PMANUMBER|SUPPLEMENTNUMBER|APPLICANT|STREET_1|STREET_2|CITY|STATE|ZIP|ZIP_EXT|GENERICNAME|TRADENAME|PRODUCTCODE|ADVISORYCOMMITTEE|SUPPLEMENTTYPE|SUPPLEMENTREASON|REVIEWGRANTEDYN|DATERECEIVED|DECISIONDATE|DOCKETNUMBER|FEDREGNOTICEDATE|DECISIONCODE|AOSTATEMENT
N12159||ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL BRAND ABSORBABLE HEMOSTAT|LMG|SU|||N|10/14/1960|10/14/1960|||APPR|
N13787||Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|Solution, cleaning/lubricating, artifical eye|ENUCLENE CLEANING/LUBRICATING SOLUTION|MSI|OP|||N|04/06/1964|03/26/1997|||APWD|
N16420||COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION|MENTOR POLYTEF PASTE FOR INJECTION|LTG|EN|||N|01/20/1972|01/20/1972|||APWD|
N16837||ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM}|LXA|CV|||N|07/01/1979|08/01/1979|||APPR|
N16895||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS CONTACT LENSES (POLYMACON)|LPM|OP|||N|03/18/1971|03/18/1971|||APPR|
N17003||HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLED P BONE CEMENT|LOD|OR|||N|10/07/1971|10/07/1971|||APRL|
N17004||HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT|LOD|OR|||N|10/07/1971|10/07/1971|||APRL|
N17113||L.D. CAULK CO.|LAKEVIEW & CLARKE AVENUES||MILFORD|DE|19963||BONE CEMENT|OMNIPLASTIC BONE CEMENT|LOD|OR|||N|02/27/1981|09/16/1981|81M-0308|12/04/1981|APRL|
N17511||COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|||N|07/07/1975|09/15/1975|||APWD|
N17600||DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)|LMF|SU|||N|05/17/1974|08/26/1976|||APPR|
N17679||COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|TETRAFILCON A|LPM|OP|||N|01/01/1975|06/18/1976|||APPR|
N17752||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|HYDROCURVE|LPM|OP|||N|11/16/1978|03/31/1979||01/11/1980|APWD|
N17755||ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|ZIMMER(R) BONE CEMENT|LOD|OR|||N|05/17/1976|05/17/1976|||APRL|
N17945||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|10/11/1977|10/11/1977|||APWD|
N17987||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CSI CONTACT LENS|LPM|OP|||N|01/09/1980|09/19/1980|||APWD|
N18033||VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE CONTACT LENS|LPM|OP|||N|01/01/1980|03/18/1980|||APPR|
N18143||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|01/24/1979|04/26/1982||06/15/1979|APWD|
N18286||PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM|LMF|SU|||N|02/22/1979|07/08/1983|83M-0243|08/29/1983|APPR|
N18466||DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|||N|02/29/1980|02/22/1984|84M-0118|04/24/1984|APRL|
N50009||PFIZER, INC.|235 E 42ND ST.||NY|NY|10017||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|TERRAMYCIN DIAGNOSTIC SUSCEPTIBILITY POWDER|JTT|MI|||N|01/01/1900|02/27/1970|||APRL|
N50016||PFIZER, INC.|235 E 42ND ST.||NY|NY|10017||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|BACITRACIN DIAGNOSTIC SUSCEPTIBILITY POWDER|JTT|MI|||N|11/24/1969|11/24/1969|||APRL|
N50036||PFIZER, INC.|235 E 42ND ST.||NY|NY|10017||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW|JTT|MI|||N|11/24/1969|11/24/1969|||APRL|
N50042||PFIZER, INC.|235 E 42ND ST.||NY|NY|10017||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|POTASSIUM PENICILLIN G DIAG SYS POWDER|JTT|MI|||N|01/01/1900|02/27/1970|||APRL|
N50061||PFIZER, INC.|235 E 42ND ST.||NY|NY|10017||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|POLYMYXIN B SULFATE SUSCEPTIBILITY TESTING|LON|MI|||N|11/24/1969|11/24/1969|||APRL|
N50062||PFIZER, INC.|235 E 42ND ST.||NY|NY|10017||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|OLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER|JTT|MI|||N|11/24/1969|11/24/1969|||APRL|
N50100||PFIZER, INC.|235 E 42ND ST.||NY|NY|10017||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN|JTT|MI|||N|09/04/1969|09/04/1969|||APRL|
N50163||THE UPJOHN CO.|7000 PORTAGE RD.||KALAMAZOO|MI|49001||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN)|JTT|MI|||N|01/01/1900|07/29/1970|||APRL|
N50407||THE UPJOHN CO.|7000 PORTAGE RD.||KALAMAZOO|MI|49001||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE|JTT|MI|||N|06/30/1971|06/30/1971|||APRL|
N50413||PFIZER, INC.|235 E 42ND ST.||NY|NY|10017||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|GEOPEN SUSCEPTIBILITY POWDER|JTT|MI|||N|09/10/1970|09/10/1970|||APRL|
N50487||MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|12/27/1976|05/09/1977|||APRL|
N50494||PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|05/01/1977|04/25/1980|||APRL|
N50510||BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|||N|12/20/1976|03/02/1978|||APRL|
N50524||ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|04/28/1978|05/04/1979|||APRL|
N50525||Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|05/05/1978|05/04/1979|||APWD|
N50531||TREK DIAGNOSTIC SYSTEMS, INC.|210 BUSINESS PARK DR.||SUN PRAIRIE|WI|53590||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|SENSITITRE|LON|MI|||N|07/19/1978|05/04/1979|||APRL|
N50538||FLOW LABORATORIES, INC.|7655 OLD SPRINGHOUSE RD.||MCLEAN|VA|22102||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|FLOW MIC SYSTEM|LON|MI|||N|09/14/1979|07/15/1980||11/20/1980|APRL|
N60242||Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL|MS 2 AUTOMATED SYSTEM|JTN|MI|||N|05/05/1978|05/04/1979|||APWD|
N61034||THE UPJOHN CO.|7000 PORTAGE ROAD||KALAMAZOO|MI|49001||SUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL|LINCOCIN SUSCEPTIBILITY PWD|JTT|MI|||N|10/09/1968|10/09/1968|||APRL|
N62160||AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|06/07/1978|04/04/1979|||APRL|
N80535||INGREDION INCORPORATED|10 FINDERNE AVENUE|SUITE C|BRIDGEWATER|NJ|08807||POWDER, DUSTING, SURGICAL|ABSORBO(R) DUSTING POWDER|KGP|HO|||N|03/02/1973|03/02/1973|||APWD|
N85356||HUBINGER CO.|601 MAIN ST.||KEOKUK|IA|52632||POWDER, DUSTING, SURGICAL|ABSORBABLE DUSTING POWDER|KGP|HO|||N|12/01/1978|12/20/1978|||APPR|
P760001||ALERE, INC.|10 Southgate Road||Scarborough|ME|04074||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AFP RIA KIT|LOK|IM|||N|12/16/1976|01/13/1984|84M-0031|02/17/1984|APWD|
P770001||FISHER SCIENTIFIC CO., LLC.|526 ROUTE 303||ORANGEBURG|NY|10962||GONOCOCCAL ANTIBODY TESTS|FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)|LGB|MI|||N|05/20/1977|07/18/1979||06/13/1980|APPR|
P770002||BIOQUEST|P.O. BOX 243||COCKEYSVILLE|MD|21030||KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE|GONOCOCCAL PILI ANTIBODY TEST|JSX|MI|||N|05/23/1977|07/18/1979||06/13/1980|APWD|
P770005||CONCEPT, INC.|12707 U.S. 19 SOUTH||CLEARWATER|FL|33546||OCCLUDER, BALLOON, VENA-CAVA|HUNTER-SESSIONS VENA-CAVA OCCLUDER|LWT|CV|||N|07/07/1977|12/19/1977||05/20/1978|APPR|
P780002||SYNOVIS SURGICAL INNOVATIONS|2575 UNIVERSITY AVE. WEST||ST. PAUL|MN|55114|1024|TISSUE GRAFT OF 6MM AND GREATER|DARDIK BIOGRAFT|LXA|CV|||N|06/12/1978|01/17/1979||07/24/1979|APWD|
P780005||Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA AP6C-2|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT AFP|LOK|IM|||N|10/03/1978|06/25/1984|84M-0238|07/25/1984|APWD|
P780006||EASTMAN KODAK COMPANY|BLDG.15,6TH FLOOR|343 STATE STREET|ROCHESTER|NY|14650|1252|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AMERSHAM AFP|LOK|IM|||N|10/12/1978|06/07/1984|84M-0227|07/06/1984|APPR|
P780007||COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|HYDRON HYDROPHILIC CONTACT LENS|LPM|OP|||N|10/16/1978|04/06/1979||08/21/1979|APPR|
P780009||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|BYREL PROGRAMABLE PACEMAKER|LWP|CV|||N|11/20/1978|03/27/1979||08/03/1979|APWD|
P780010||COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS (PERFILCON A) SOFT HYDROPHILIC CONTACT LENS|LPM|OP|||N|11/14/1978|06/11/1979||12/28/1979|APWD|
P780011||BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|||N|11/27/1978|05/15/1980|||APWD|
P780012||Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|HAVAB|LOL|MI|||N|11/03/1978|01/19/1979|79M-0145|05/15/1979|APRL|
P790002||EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIO OSTEOGEN SYSTEM 204|LOF|OR|||N|01/15/1979|11/06/1979|80M-0057|04/25/1980|APPR|
P790005||EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|01/31/1979|01/25/1980|80M-0254|07/18/1980|APPR|
P790006||Allergan, Inc.|5540 EKWILL STREET||SANTA BARBARA|CA|93111||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|ANGELCHIK ANTI-REFLUX PROSTHESIS|LEI|GU|||N|02/05/1979|10/19/1979||07/18/1980|APWD|
P790007||MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS|LWR|CV|||N|02/21/1979|11/15/1979||08/08/1980|APPR|
P790010||CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lens, contact (other material) - daily|DANKER SILICONE LENS (DIMEFOCON-A)|HQD|OP|||N|03/13/1979|05/28/1982||07/13/1982|APWD|
P790016||WESTPORT PHARMACEUTICALS, INC.|P.O. BOX 5022||WESTON|CT|06881||SALIVA, ARTIFICIAL|SALIVART|LFD|DE|||N|06/12/1979|09/19/1979|80M-0058|04/25/1980|APPR|
P790017||MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI DILATATION CATHETER|LOX|CV|||N|06/15/1979|03/24/1980|80M-0246|07/18/1980|APRL|
P790018||MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|06/29/1979|12/23/1981|82M-0003|01/29/1982|APWD|
P790019||Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M DIAGNOSTIC KIT|LOL|MI|||N|08/27/1979|06/10/1980|80M-0366|11/21/1980|APRL|
P790020||ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|PERMAFLEX (SURFILCON A)(VASURFILCON A)|LPM|OP|||N|09/04/1979|04/07/1980|85M-0167|09/16/1980|APWD|
P790025||Abbott Laboratories|100 ABBOTT PARK RD.|DEPT: 09VA BLDG: AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT HBE DIAGNOSTIC KIT|LOM|MI|||N|10/03/1979|07/15/1980|80M-0267|09/12/1980|APWD|
P790027||BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|10/26/1979|03/02/1982||03/26/1982|APWD|
P790028||BAYER HEALTHCARE|430 South Beiger Street||MISHAWAKA|IN|46544||CONTROLLER, CLOSED-LOOP BLOOD GLUCOSE|BIOSTATOR GCIIS|LHE|HO|||N|11/16/1979|12/04/1980||02/20/1981|APWD|
P790032||INCSTAR CORP.|1990 INSUSTRIAL BLVD.|P.O. BOX 285|STILLWATER|MN|55082|0285|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|GAMMA DAB (125I) AFP RIA KIT|LOK|IM|||N|12/21/1979|04/30/1986|86M-0206|06/17/1986|APWD|
P800002||C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB|LMF|SU|||N|01/18/1980|10/24/1980|83M-0026|02/15/1983|APPR|
P800003||EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||MONITOR, LUNG WATER MEASUREMENT|MODEL 9310 LUNG WATER COMPUTER|JEZ|AN|||N|01/28/1980|07/28/1980|80M-0317|09/12/1980|APWD|
P800012||OSMED, INC.|325 LAKE AVE. SOUTH - SUITE|#608|DULUTH|MN|55802||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|DRILAC CUBES{TM}|LPG|DE|||N|03/19/1980|01/28/1983|83M-0034|02/25/1983|APWD|
P800016||Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|TENNANT(TM) & KELMAN(TM) TYPE II|HQL|OP|||N|04/15/1980|03/26/1982||04/20/1992|APWD|
P800017||STORZ OPHTHALMICS, INC.|1365 HAMLET AVE.|P.O. 2498|CLEARWATER|FL|34616||intraocular lens|CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS|HQL|OP|||N|04/16/1980|12/01/1981|81M-0385|12/11/1981|APWD|
P800019||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|04/21/1980|03/06/1981||06/09/1981|APWD|
P800022||Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|05/02/1980|07/22/1981|81M-0237|09/18/1981|APWD|
P800025||Bio-Rad Laboratories, Inc.|3 Boulevard Raymond Poincare'||Marnes-la-Coquette||92430||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|QUANTITOPE 125I AFP KIT AND CONTROL SERUM|LOK|IM|||N|05/13/1980|01/13/1984|84M-0032|02/17/1985|APWD|
P800027||STORZ OPHTHALMICS, INC.|1365 HAMLET AVE.|P.O. 2498|CLEARWATER|FL|34616||intraocular lens|BINKHORST & FEDOROV I IRIS CLIP IOLS|HQL|OP|||N|05/23/1980|07/26/1982|82M-0257|08/31/1982|APWD|
P800029||ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM|LON|MI|||N|06/02/1980|01/30/1981||04/28/1981|APRL|
P800030||BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|1875 EYE ST. NW STE. 625||WASHINGTON|DC|20006||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC|LON|MI|||N|06/03/1980|02/18/1981||03/17/1981|APRL|
P800032||MILES LABORATORIES, INC.|1127 MYRTLE ST.|P.O. BOX 40|ELKHART|IN|46514||CONTROLLER, CLOSED-LOOP BLOOD GLUCOSE|BIOSTATOR GLUCOSE CONTROLLER|LHE|HO|||N|06/05/1980|05/28/1981||06/19/1981|APPR|
P800035||CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|Bone grafting material, for dental bone repair|PERI-OSS|LPK|DE|||N|06/12/1980|03/24/1981||04/13/1981|APRL|
P800036||CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|06/23/1980|03/03/1982|82M-0072|03/26/1982|APPR|
P800040||CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|||N|07/07/1980|04/14/1981|81M-0136|06/05/1981|APWD|
P800049||ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODELS 1S & 1P|HQL|OP|||N|07/17/1980|03/31/1983|83M-0122|04/26/1983|APWD|
P800058||St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|N.C.G.T. GRAFT|LXA|CV|||N|10/03/1980|09/08/1981|81M-0307|10/23/1981|APWD|
P800061||DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|10/22/1980|06/01/1981||07/14/1981|APWD|
P800064||GENETIC LABORATORIES, INC.|1385 CENTENNIAL DRIVE ST. PAUL|, MINN.|||||GRAFT, VASCULAR, HEMODIALYSIS ACCESS, SYNTHETIC/BIOLOGICAL COMPOSITE|BIOFLOW(TM)|MCI|GU|||N|12/01/1980|03/10/1982|82M-0094|07/20/1982|APPR|
P800068||INSTRUMENTATION INDUSTRIES, INC.|1211 STREETS RUN RD.||PITTSBURG|PA|15236||Changer, tube, endotracheal|ENDOTRACHEAL TUBE CHANGER|LNZ|AN|||N|11/21/1980|07/21/1981||08/14/1981|APRL|
P810001||ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODEL AC (AC1-AC5)|HQL|OP|||N|01/08/1981|03/17/1983|83M-0103|04/12/1983|APWD|
P810002||St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|||N|01/22/1981|12/17/1982|83M-0004|03/01/1983|APPR|
P810005||CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, extended wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPM|OP|||N|02/20/1981|09/24/1981|81M-0317|11/03/1981|APCB|
P810006||INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|||N|03/02/1981|12/10/1981|81M-0402|01/05/1982|APPR|
P810007||NARCO SCIENTIFIC|330 JACKSONVILLE RD.||HATBORO|PA|19040||Meter, jaundice|JAUNDICE METER 101|LMX|HO|||N|03/05/1981|11/20/1981|81M-0383|12/18/1981|APPR|
P810018||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|04/21/1981|07/16/1982|82M-0253|08/31/1982|APWD|
P810020||SMITH & NEPHEW RICHARDS, INC.|1450 BROOKS RD.||MEMPHIS|TN|38116||BONE CEMENT|PALACOS R BONE CEMENT|LOD|OR|||N|05/13/1981|02/02/1984|84M-0053|02/28/1984|APRL|
P810023||GAMBRO BCT, INC.|10811 West Collins Ave.||Lakewood|CO|80215||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|COBE CENTRY(R) TPE SYSTEM|LKN|GU|||N|05/18/1981|03/16/1982||04/09/1982|APWD|
P810024||WARNER-LAMBERT CO.|201 TABOR RD., MORRIS PLAINS N|J|||||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MTS PLUS TEST SYTEM|LON|MI|||N|05/19/1981|03/04/1982|82M-0070|03/26/1982|APRL|
P810025||Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC(R)|LZP|OP|||N|05/28/1981|10/18/1983|83M-0374|11/28/1983|APPR|
P810031||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|||N|07/07/1981|01/14/1983|83M-0022|02/08/1983|APPR|
P810032||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|||N|07/08/1981|04/23/1982|82M-0142|05/25/1982|APPR|
P810033||AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|ELECTRODE, STABILIZED EPIDURAL SPINAL|SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355|LHY|NE|||N|07/09/1981|02/02/1982|82M-0036|03/02/1982|APWD|
P810040||SUPERSTAT CORP.|2015 UNIVERSITY DR.||RANCHO DOMINGUEZ|CA|90220|6411|Agent, absorbable hemostatic, collagen based|SUPERSTAT|LMF|SU|||N|08/05/1981|01/29/1982|82M-0023|06/25/1982|APPR|
P810042||PHARMACIA, INC.|605 E. HUNTINGTON DR.|P.O. BOX 5036|MONROVIA|CA|91016||intraocular lens|MODELS 011 & 011B IRIDOCAPSULAR IOLS|HQL|OP|||N|08/17/1981|12/15/1982|83M-0005|01/25/1983|APPR|
P810044||DIABETES SENTRY PRODUCTS, LLC|501 Samuels Ave.|Unit #110|Fort Worth|TX|76102||MONITOR, SKIN RESISTANCE/SKIN TEMPERATURE,  FOR INSULIN REACTIONS|DIABETES SENTRY|LMY|HO|||N|08/28/1981|07/08/1982|82M-0243|09/17/1982|APPR|
P810046||ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|09/11/1981|03/03/1982|82M-0071|03/26/1982|APRL|
P810048||Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|||N|10/06/1981|11/05/1982|81M-0373|12/10/1982|APWD|
P810055||ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|11/25/1981|02/03/1983|83M-0047|02/25/1983|APWD|
P810056||ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|||N|11/25/1981|07/26/1983|83M-0275|08/16/1983|APWD|
P820002||STRATO MEDICAL CORP.|PFIZER HOSPITAL PRODUCTS GROUP|123 BRIMBAL AVE|BEVERLY|MA|01915||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|CRYOMAX(TM)|LKN|GU|||N|01/05/1982|01/31/1983|83M-0039|02/18/1983|APPR|
P820003||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|01/06/1982|11/16/1982|82M-0377|01/07/1983|APPR|
P820008||EBI, L.P.|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||STIMULATOR, FUNCTIONAL NEUROMUSCULAR, SCOLIOSIS|SCOLITRON(TM) STIMULATOR|LWB|PM|||N|01/29/1982|01/06/1983|83M-0053|02/25/1983|APWD|
P820009||BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Catheter, balloon for retinal reattachment|LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER|LOG|OP|||N|02/22/1982|10/25/1983|83M-0370|11/21/1983|APWD|
P820012||Integra LifeSciences Corp.|22 TERRY AVENUE||BURLINGTON|MA|01803||MONITOR, INTRACRANIAL PRESSURE, IMPLANTED|COSMAN ICP TELE-SENSOR(R)|LII|NE|||N|03/02/1982|09/02/1982|82M-0294|10/01/1982|APWD|
P820018||St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|03/30/1982|02/10/1983|83M-0055|03/11/1983|APWD|
P820021||Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|||N|04/01/1982|03/31/1983|83M-0123|04/29/1983|APPR|
P820022||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER|LWW|CV|||N|04/07/1982|11/07/1984|84M-0386|12/12/1984|APWD|
P820023||PACESETTER SYSTEMS|12884 BRADLEY AVE.||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P|LWP|CV|||N|04/12/1982|02/04/1983|83M-0048|02/25/1983|APWD|
P820027||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||System, identification, contact lens|SOFTMARK|LOH|OP|||N|04/28/1982|06/22/1983|83M-0215|07/19/1983|APWD|
P820032||FENWAL, INC.|THREE CORPORATE DRIVE||LAKE ZURICH|IL|60047||CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES|PLASMA SEPARATION SYSTEM|LMN|GU|||N|05/25/1982|10/07/1983|83M-0352|11/03/1983|APWD|
P820033||Asahi Kasei Medical Co., Ltd.|1-105 KANDA JINBOCHO|CHIYODA-KU|TOKYO||101-8|8101|Separator for therapeutic purposes, membrane automated blood cell/plasma|PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR|MDP|GU|||N|05/26/1982|07/05/1983|83M-0236|08/12/1983|APPR|
P820034||REPRO-MED SYSTEMS, INC.|24 CARPENTER RD.||CHESTER|NY|10918||DEVICE, TESTICULAR HYPOTHERMIA|REPRO-MED - THD|LOA|GU|||N|05/28/1982|12/26/1984|85M-0007|01/25/1985|APPR|
P820035||ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5)|HQL|OP|||N|05/28/1982|02/28/1986|86M-0231|06/18/1986|APWD|
P820044||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL 91-50 IOL|HQL|OP|||N|07/12/1982|12/27/1985|86M-0032|02/14/1986|APWD|
P820049||ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|07/08/1982|05/17/1983|83M-0174|06/17/1983|APWD|
P820052||DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|||N|08/03/1982|08/31/1983||10/12/1983|APWD|
P820060||Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER|LOK|IM|||N|08/13/1982|06/21/1983|83M-0217|07/19/1983|APWD|
P820072||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|09/30/1982|07/21/1983||08/09/1983|APWD|
P820073||BOEHRINGER MANNHEIM CORP.|7800 WESTPARK DR.||HOUSTON|TX|77063||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICUR-MIC SYSTEMS|LON|MI|||N|10/07/1982|06/29/1983|83M-0226|07/19/1983|APRL|
P820075||Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL(TM)|LOB|OB|||N|10/07/1982|06/21/1983|83M-0216|07/19/1983|APWD|
P820076||BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 05 A & B|LWP|CV|||N|10/12/1982|02/15/1984|84M-0089|04/06/1984|APPR|
P820077||CENTERS FOR DISEASE CONTROL AND PREVENTION|1600 CLIFTON RD, MS-C18||ATLANTA|GA|30333||CALIBRATOR FOR ALPHA-FETOPROTEIN IN MID-PREGNANCY MATERNAL SERUM|AFP MID-PREGNANCY REFERENCE PREPARATION|LTQ|IM|||N|10/19/1982|11/30/1984|84M-0410|01/03/1985|APWD|
P820078||ALDEN OPTICAL LABS., INC.|13295 BROADWAY||ALDEN|NY|14004||Lenses, soft contact, daily wear|AL-47 SOFT CONTACT LENS|LPL|OP|||N|10/27/1982|01/30/1984|84M-0055|03/09/1984|APRL|
P820079||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|CDS II (SODIUM CHONDROITIN SULFATE)|LZP|OP|||N|10/25/1982|09/30/1986|86M-0408|11/05/1986|APWD|
P820086||CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, extended wear|CIBATINT(TM) TINTING PROCESS|LPM|OP|||N|12/20/1982|02/08/1984|84M-0091|04/10/1984|APWD|
P820088||PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|||N|05/19/1982|11/28/1983|84M-0007|01/25/1984|APPR|
P830007||TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|02/07/1983|11/10/1983|83M-0389|12/07/1983|APPR|
P830010||ORGANON TEKNIKA CORP.|5300 SOUTH PORTLAND AVE.||OKLAHOMA CITY|OK|73119||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|CURESIS PLASMA SEPARATOR|LKN|GU|||N|03/02/1983|09/19/1984|84M-0338|11/09/1984|APPR|
P830018||ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||Hepatitis a test (antibody and igm antibody)|HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM|LOL|MI|||N|04/05/1983|02/06/1989|89M-0057|04/17/1989|APRL|
P830025||MEDICAL LASER, INC.|5454 WISCONSIN AVE.||CHEVY CHASE|MD|20815||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MEDITEC OPL3 ND:YAG LASER|LOI|OP|||N|06/02/1983|01/14/1985|85M-0038|02/21/1985|APPR|
P830026||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|06/06/1983|03/23/1984|84M-0130|04/25/1984|APPR|
P830028||ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||Manual antimicrobial susceptibility test systems|UNISCEPT(TM)|JWY|MI|||N|03/25/1983|03/01/1984|84M-0129|04/25/1984|APRL|
P830033||ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|||N|06/29/1983|09/05/1985|85M-0450|10/17/1985|APWD|
P830035||INDEVUS PHARMACEUTICALS, INC.|8 CLARKE DR.||CRANBURY|NJ|08512||SOLUTION, REMOVAL, CARRIES|GK-101E CARIES REMOVAL AGENT/SYSTEM|LMW|DE|||N|07/01/1983|07/06/1984|84M-0248|05/02/1986|APWD|
P830037||Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|||N|07/07/1983|04/24/1984|84M-0164|05/31/1984|APPR|APPROVAL FOR THE DURASOFT 3 (PHEMFILCON A) EXTENDED WEAR HYDROPHILIC CONTACT LENS.  THE LENS IS INDICATED FOR UP TO 14 DAYS OF CONTINUOUS WEAR BETWEEN CLEANING AND DISINFECTION (EXTENDED WEAR) BY PERSONS WITH EYES THAT ARE NON-DISEASED, NOT-APHAKIC, HAVE NO MORE THAN 2.00 DIOPTERS (D) OF ASTIGMATISM, AND REQUIRE A SPHERICAL LENS IN THE POWER RANGE FROM -20.00 D TO +0.00 D FOR THE CORRECTION OF NEARSIGHTEDNESS (MYOPIA) OR FARSIGHTEDNESS (HYPEROPIA).  THE LENS IS TO BE DISINFECTED USING EITHER A HEAT (THERMAL) OR A CHEMICAL (NOT HEAT) DISINFECTION SYSTEM.
P830039||MEDICALCV, INC.|9725 SOUTH ROBERT TRAIL||INVER GROVE HEIGHTS|MN|55077||HEART-VALVE, MECHANICAL|OMNISCEINCE PROSTHETIC CARDIAC VALVE|LWQ|CV|||N|07/07/1983|05/03/1985|85M-0386|09/11/1985|APWD|
P830040||ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|STYLES 30 & 31 POSTERIOR CHAMBER IOLS|HQL|OP|||N|07/14/1983|09/05/1985|85M-0451|10/17/1985|APWD|
P830045||St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|07/19/1983|03/22/1984|84M-0126|04/20/1984|APWD|
P830047||ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|Lenses, soft contact, extended wear|X-70 SOFT CONTACT LENS|LPM|OP|||N|07/28/1983|03/29/1985|85M-0166|05/10/1985|APWD|
P830054||COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|||N|06/03/1983|07/02/1984|84M-0244|07/30/1984|APPR|
P830055||DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM|NJL|OR|||N|08/16/1983|04/12/1985|85M-0195|05/20/1985|APPR|
P830056||CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLES 31-34 POSTERIOR IOLS|HQL|OP|||N|10/18/1983|03/28/1986|86M-0239|06/18/1986|APWD|
P830060||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS|LWS|CV|||N|09/26/1983|10/04/1985|85M-0504|11/15/1985|APPR|Approval for the Automatic Implantable Cardioverter Defibrillator (AICD).  The device is indicated for the treatment of ventricular tachycardia and ventricular fibrillation in those patients who are at high risk of sudden cardia death.  Such patients are defined as (1) those who have survived at least one episode of cardiac arrest presumably due to hemodynamically unstable ventricular tachyarrhythmia not associated with acute myocardial infarction, and (2) those who, in the absence of such previous arrest, have experienced recurrent ventricular tachyarrhythmias and are inducible into sustained hypotensive ventricular tachycardia and/or fibrillation despite conventional antiarrhythmic drug therapy.  The patients who meet the above criteria should have also undergone a complete cardiological evaluation that includes electrophysiological testing.
P830061||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING|NVN|CV|||N|10/03/1983|07/29/1986|86M-0330|08/22/1986|APPR|
P830062||NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|||N|01/25/1983|09/27/1984|84M-0353|11/26/1984|APWD|
P830063||BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|GAMBRO FIBER PLASMAFILTER|MDP|GU|||N|10/04/1983|05/27/1986|86M-0250|07/07/1986|APPR|Approval for the Gambro Fiber Plasmafilter PP.  This device is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulation plasma components or protein bound toxins.
P830069||Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN|MCM|EN|||N|10/14/1983|11/26/1984|84M-0395|12/24/1984|APWD|
P830070||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|LPL|OP|||N|10/17/1983|12/11/1984|84M-0434|01/18/1985|APWD|
P830079||ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|||N|12/23/1983|10/10/1985|85M-0507|11/15/1985|APPR|
P830080||SYNEMED, INC.|1215 - 4TH ST.||BERKELEY|CA|94710||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER|LOI|OP|||N|12/30/1983|02/17/1987|87M-0077|04/06/1987|APPR|
P840001||MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|||N|01/13/1984|11/30/1984|84M-0415|01/02/1985|APPR|
P840002||CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|STAT-PACE II|LPA|CV|||N|11/19/1984|04/30/1986|86M-0237|07/01/1986|APPR|
P840008||Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)|LNS|GU|||N|02/22/1984|12/19/1984|84M-0438|01/16/1985|APRL|
P840012||MERIDIAN AG|BIERIGUTSTRAUSS 7|CH-3608|THUN, BE||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MICRORUPTOR MR-2 ND:YAG LASER SYSTEM|LOI|OP|||N|03/19/1984|01/31/1986|86M-0106|03/28/1986|APWD|
P840014||PACESETTER SYSTEMS|12884 BRADLEY AVE.||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|DDD PULSE GENERATOR 674|LWP|CV|||N|03/21/1984|07/31/1986|86M-0343|09/08/1986|APPR|
P840015||CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|||N|03/28/1984|08/16/1985|85M-0416|09/11/1985|APPR|
P840024||Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|||N|05/31/1984|10/31/1985|85M-0524|12/09/1985|APPR|
P840027||ROCHE DIAGNOSTICS GMBH|1080 U.S. HWY. 202|BRANCHBURG TOWNSHIP|SOMERVILLE|NJ|08876|3771|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE(R) EIA|DHX|IM|||N|06/19/1984|05/13/1985|85M-0253|06/12/1985|APWD|
P840029||MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|MICROVEL(R) WITH HEMASHIELD|DSY|CV|||N|06/28/1984|04/26/1989|89M-0170|06/06/1989|APRL|
P840031||LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|SAULFON PW-70 A&B|LPM|OP|||N|07/05/1984|04/12/1985|85M-0224|06/19/1985|APWD|
P840039||Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES|HQL|OP|||N|08/27/1984|03/28/1986|86M-0169|07/01/1986|APPR|
P840040||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|||N|09/05/1984|12/19/1985|86M-0029|02/10/1986|APWD|
P840044||Toray Industries (America), Inc.|1-1-1 SONOYAMA||OTSU-SHI, SHIGA-KEN 520||520||Lenses, soft contact, extended wear|TORAY SOFT CONTACT LENSES|LPM|OP|||N|09/24/1984|01/24/1986|86M-0054|03/05/1986|APWD|
P840045||MEDICEM TECHNOLOGY S.R.O|KARLOVARSHA TRIDA 20||KAMENNE ZEHROVICE||27301||dilator, cervical, synthetic, osmotic, pregnancy termination|DILAPAN-S CERVICAL DILATOR|LOB|OB|||N|09/24/1984|04/28/1986|86M-0201|06/11/1986|APWD|
P840047||COOPERVISION-CILCO|1616 13TH AVE., HUNTINGTON, W.|VA|||||Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla|CILCO ND:YAG LASER|LXS|OP|||N|10/02/1984|08/02/1985|85M-0402|09/11/1985|APRL|
P840050||O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|||N|10/09/1984|11/20/1985|85M-0558|01/02/1986|APPR|
P840060||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|||N|11/14/1984|04/30/1986|86M-0232|06/11/1986|APPR|
P840062||COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(TM)|LPG|DE|||N|11/23/1984|11/08/1985|85M-0556|01/02/1986|APPR|
P840064||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES|LZP|OP|||N|11/29/1984|04/30/1986|86M-0207|06/06/1986|APPR|
P840065||ROCHE DIAGNOSTICS GMBH|1 SUNSET AVE.||MONTCLAIR|NJ|07042|5199|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|COBAS BACT|LON|MI|||N|11/30/1984|05/30/1986|86M-0249|07/07/1986|APRL|
P840068||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA PACEMAKER SYS; VIGOR DDD MODEL 950|LWP|CV|||N|12/21/1984|11/27/1985|85M-0579|01/24/1986|APPR|
P840070||ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST|LOM|MI|||N|12/26/1984|05/14/1986|86M-0238|07/01/1986|APPR|
P850006||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|DUROMEDICS BILEAFLET HEART VALVE|LWQ|CV|||N|02/04/1985|08/29/1986|86M-0377|09/26/1986|APPR|
P850007||Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM(TM) I & II MODEL 6000 & 7000|LOF|OR|||N|02/12/1985|02/21/1986|86M-0138|04/18/1986|APPR|
P850010||INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|||N|02/20/1985|11/08/1985|85M-0557|01/02/1986|APPR|
P850019||LASER MEDIA|77 ARKAY DR.||HAUPPAUGE|NY|11788||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|PHOTOTOME(TM) SYSTEM 2700|LOI|OP|||N|03/28/1985|08/08/1985|85M-0391|09/18/1985|APPR|
P850020||FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||Separator for therapeutic purposes, membrane automated blood cell/plasma|PROSORBA(TM) COLUMN|MDP|GU|||N|04/02/1985|12/23/1987|88M-0019|02/23/1988|APWD|
P850021||ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|||N|04/03/1985|05/30/1986|86M-0259|07/09/1986|APWD|
P850022||EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK(R) BONE GROWTH STIMULATOR|LOF|OR|||N|04/11/1985|02/18/1986|86M-0139|04/09/1986|APPR|
P850023||Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT|LMF|SU|||N|04/17/1985|05/27/1986|86M-0248|07/07/1986|APPR|
P850027||TELECTRONICS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|TELECTRONICS PASAR MODEL 4171 PG|LWW|AN|||N|05/06/1985|09/30/1986|86M-0402|11/10/1986|APPR|
P850029||Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK,|IL|60064|3537|KIT, ASSAY, ESTROGEN RECEPTOR|ABBOTT ER-EIA MONOCLONAL DIAG. KIT|LPJ|CH|||N|05/17/1985|10/17/1988|88M-0368|12/16/1988|APWD|
P850033||CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|SCANLENS (SCAFILCON A CONTACT LENS)|LPL|OP|||N|05/30/1985|11/28/1986|86M-0501|01/16/1987|APWD|
P850035||EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|||N|05/31/1985|04/30/1987|87M-0174|06/10/1987|APPR|
P850038||PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens,contact(rigid gas permeable)-extended wear|PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN|MWL|OP|||N|06/05/1985|12/31/1986|87M-0010|02/18/1987|APPR|
P850039||Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, extended wear|B&L 58(TM) (ETAFILCONA) CONTACT LENS|LPM|OP|||N|06/06/1985|08/16/1985|85M-0420|09/23/1985|APWD|
P850048||BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|MTF|IM|||N|07/09/1985|02/25/1986|86M-0137|04/09/1986|APPR|
P850049||COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|COOK BIRD'S NEST VENA CAVA FILTER|DTK|CV|||N|07/10/1985|04/26/1989|89M-0193|06/29/1989|APRL|
P850051||MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|||N|07/19/1985|06/10/1986|86M-0266|07/11/1986|APPR|
P850053||MENTOR CORP.|201 MENTOR DRIVE||SANTA BARBARA|CA|93111||Implant, dermal, for aesthetic use|FIBREL|LMH|SU|||N|07/31/1985|02/26/1988|88M-0094|05/03/1988|APWD|
P850054||MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.|112 BAUER DR.||OAKLAND|NJ|07436||LIGAMENTS AND TENDONS, SYNTHETIC|STRKYER KNEE AUGMENTATION GRAFT|LML|OR|||N|08/05/1985|12/30/1988|89M-0043|04/18/1989|APWD|
P850057||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|CUSTOMEYES(TM) 45L&55L (BUFILCON A)|LPL|OP|||N|08/12/1985|04/14/1986|86M-0184|07/01/1986|APWD|
P850058||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|CUSTOMEYES 70L & 79L (LIDOFILCON A&B)|LPL|OP|||N|08/12/1985|04/30/1986|86M-0230|07/01/1986|APWD|
P850059||BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|||N|08/15/1985|07/31/1986|87M-0008|02/18/1987|APWD|
P850062||Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|HEPATITIS DELTA SEROLOGICAL REAGENTS|ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)|LQI|MI|||N|08/29/1985|07/01/1986|86M-0308|08/07/1986|APWD|
P850063||SORIN GROUP USA INC.|14401 WEST 65TH WAY||ARVADA|CO|80004||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MICRO YAG ND:YAG LASER SYSTEM|LOI|OP|||N|09/03/1985|01/31/1986|86M-0107|05/30/1986|APWD|
P850064||BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|||N|09/04/1985|06/30/1988|88M-0263|08/10/1988|APPR|
P850068||Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, extended wear|SILSOFT (ELASTOFILCON A) CONTACT LENSES|LPM|OP|||N|09/13/1985|12/31/1985|86M-0030|02/10/1986|APPR|
P850069||3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|||N|09/19/1985|05/07/1987|87M-0173|06/16/1987|APWD|
P850072||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS|LPL|OP|||N|09/30/1985|07/17/1986|86M-0325|08/14/1986|APWD|
P850077||COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPM|OP|||N|10/30/1985|01/31/1986|86M-0108|03/28/1986|APWD|
P850078||KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, extended wear|KONTUR 55 EW|LPM|OP|||N|10/30/1985|01/31/1986|86M-0109|03/28/1986|APWD|APPROVAL FOR THE SPHERICAL AND TORIC CONFIGURATIONS OF THE KONTUR SOFTMETHAFILCON A HY4ROPHILIC CONTACT LENS THE SPHERICAL LENS IS INDICATED FORDAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT APHAKICPERSONS WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROP1C THE LENS MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1 50 DIOPTERS D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY THE LENS RANGES 1N POWERS FROM 20 00 D TO 20 00 D THE TORIC LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY 1N NOT APHAKIC PERSONS W1TH NOND1SEASED EYES THAT ARE MYOPIC HYPEROPIC OR HAVE REFRACTIVE ASTIGMATISM NOT EXCEEDING 5 00 D THAT DOES NOT 1NTERFERE WITH VISUAL ACUITY THE LENS CANGES IN POWERS FROM 20 00 D TO 10 00 D BOTH CONFIGURATIONS OF THE LENS ARE TO BE DISINFECTED USING A CHEMICAL LENS CARE SYSTEM.
P850079||COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|HYDRASOFT (METHAFILCON B) CONTACT LENS|LPM|OP|||N|10/30/1985|01/31/1986|86M-0110|03/28/1986|APPR|
P850089||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS|NVN|CV|||N|12/17/1985|07/29/1986|86M-0329|08/22/1986|APPR|
P850091||Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|YAGMASTER ND:YAG OP LASER|LOI|OP|||N|12/18/1985|04/30/1987|87M-0165|06/10/1987|APWD|
P850092||MILLIPORE CORP.|80 ASHBY RD.|P.O. BOX 9125|BEDFORD|MA|01730||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|THERAPEUTIC APHERESIS SYSTEM|LKN|GU|||N|12/18/1985|11/18/1986|86M-0481|12/24/1986|APWD|
P860002||BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|INTRAOCULAR LENS|HQL|OP|||N|01/06/1986|10/31/1986|86M-0469|12/16/1986|APWD|
P860003||THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|||N|01/24/1986|04/08/1987|87M-0136|05/18/1987|APPR|
P860004||MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM|LKK|HO|||N|02/03/1986|03/14/1988|88M-0114|05/11/1988|APPR|Approval for the Medtronic® SynchroMed™ Infusion System.  This device is indicated for chronic intravascular infusion of floxuridine (FUDR) or doxorubicin hydrochloride (Adriamycin) and, when required bacteriostatic water, physiological saline and/or heparin.
P860005||INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|Calcium salt bone void filler, drillable, non-screw augmentation|PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER|OIS|OR|||N|02/10/1986|10/29/1992|92M-0450|04/19/1993|APRL|
P860007||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH TM IMPLANTABLE PACEMAKER PULSE|LWW|CV|||N|03/03/1986|12/31/1986|87M-0031|03/11/1987|APWD|
P860008||CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7|LPA|CV|||N|03/17/1986|12/30/1986|87M-0009|02/25/1987|APPR|
P860012||COLLAGEN CORP.|2500 FABER PLACE||PALO ALTO|CA|94303||IMPLANT, ENDOSSEOUS, ROOT-FORM|ALVEOFORM TM BIOGRAFT|DZE|SU|||N|04/02/1986|10/28/1988|89M-0003|02/15/1989|APRL|
P860015||ZEUS TECHNOLOGIES|P.O. Box 38||Raritan|NJ|08869||KIT, ASSAY, ESTROGEN RECEPTOR|FLUORO-CEP{R} ESTROGEN ASSAY REAGENT|LPJ|CH|||N|04/28/1986|02/29/1988|88M-0091|05/11/1988|APWD|
P860019||SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|||N|05/23/1986|11/28/1986|86M-0496|01/16/1987|APRL|
P860022||POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens,contact(rigid gas permeable)-extended wear|BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS|MWL|OP|||N|06/02/1986|11/30/1987|87M-0395|01/19/1988|APPR|
P860026||AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR|GZE|AN|||N|07/03/1986|01/05/1987|87M-0022|02/25/1987|APPR|
P860027||CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO SERIES 500 P.G. MODELS 501, 505, 509|LWP|CV|||N|07/28/1986|02/27/1987|87M-0085|04/16/1987|APPR|
P860034||ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC-21 OMNIFIT ANTERIOR CHAMBER|HQL|OP|||N|01/20/1984|09/29/1989|89M-0425|11/13/1989|APWD|
P860035||IVAC CORPORATION|10300 CAMPUS POINT DR.||SAN DIEGO|CA|92121||CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE|TITRATOR MODEL 10K|LSX|HO|||N|08/21/1986|12/17/1987|88M-0005|02/10/1988|APPR|
P860040||WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, extended wear|SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPM|OP|||N|08/28/1986|02/19/1987|87M-0073|04/07/1987|APPR|
P860042||TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|||N|09/02/1986|02/27/1987|87M-0076|04/06/1987|APWD|
P860046||SONOCARE, INC.|21 INDUSTRIAL AVE.||U. SADDLE RIVER|NJ|07458||Ultrasound, cyclodestructive|THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA|LZR|OP|||N|10/01/1986|06/30/1988|88M-0266|08/10/1988|APPR|
P860047||Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML|LZP|OP|||N|10/06/1986|07/12/1988|88M-0271|08/18/1988|APPR|
P860057||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES|DYE|CV|||N|11/18/1986|09/26/1991|91M-0397|11/12/1991|APPR|Approval for the Carpentier-Edwards® Pericardial Bioprosthesis, Model 2700.  This device is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one.  It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement.
P860059||ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|||N|12/04/1986|02/12/1988|88M-0066|03/28/1988|APWD|
P860064||C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KIT|LNY|HO|||N|12/12/1986|02/29/1988|88M-0092|05/03/1988|APPR|
P860067||BIOSONICS, INC.|260 NEW YORK DR., SUITE A||FORT WASHINGTON|PA|19034|2504|Stimulator, salivary system|SALITRON SYSTEM|LTF|DE|||N|12/19/1986|05/17/1988|88M-0205|07/14/1988|APPR|
P870011||TOWERS PERRIN|335 MADISON AVE.||NEW YORK|NY|10017|4605|Lithotriptor, extracorporeal shock-wave,urological|HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE|LNS|GU|||N|02/27/1987|09/06/1990|90m-0303|10/19/1990|APRL|
P870013||BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR|HQL|OP|||N|03/09/1987|03/31/1988|88M-0159|07/20/1988|APWD|
P870015||MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT|LNS|GU|||N|04/13/1987|04/15/1988|88M-0186|06/07/1988|APRL|
P870018||SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|||N|04/28/1987|09/30/1988|88M-0363|11/30/1988|APRL|
P870021||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Catheters, transluminal coronary angioplasty, percutaneous|PRIME{TM} MODEL 6520, 6525, 6530 AND 6535|LOX|CV|||N|05/05/1987|02/29/1988|88M-0106|05/11/1988|APRL|
P870024||PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens,contact(rigid gas permeable)-extended wear|FLUOROPERM RGP CONTACT LENSES|MWL|OP|||N|05/20/1987|12/31/1987|88M-0013|02/22/1988|APPR|
P870025||GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY|MCP|OB|||N|05/20/1987|08/31/1988|88M-0346|11/30/1988|APWD|
P870036||MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|||N|06/16/1987|03/25/1988|88M-0160|06/24/1988|APWD|
P870038||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES|LWQ|CV|||N|06/29/1987|09/27/1991|91M-0420|11/14/1991|APPR|
P870043||TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|||N|07/29/1987|06/30/1988|88M-0264|08/10/1988|APWD|
P870045||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|SK15 AND SK16|HQL|OP|||N|07/28/1987|01/24/1990|90M-0053|02/27/1990|APWD|
P870048||DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|EBK|LOM|MI|||N|08/18/1987|07/13/1990|90M-0244|10/01/1990|APWD|
P870049||DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID PANELS|LON|MI|||N|08/20/1987|02/24/1988|88M-0083|04/11/1988|APRL|
P870054||COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR|DXY|CV|||N|09/08/1987|04/29/1988|88M-0187|06/09/1988|APWD|
P870056||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625|DYE|CV|||N|09/24/1987|09/25/1991|91M-0395|11/12/1991|APPR|Approval for the Carpentier-Edwards® Bioprosthesis, Models 2625 (aortic) and 6625 (mitral).   This device is intended for use in patients whose aortic or mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one.  It is also intended for use in patients with a previously implanted aortic or mitral valve prosthesis which is no longer functioning adequately and requires replacement.
P870059||ACTECH ADVANCED CLINICAL TECHNOLOGIES, INC.|117 BROADWAY||NORWOOD,|MA|02062||KIT, TEST, IN VITRO PERIODONTAL|PERIOCHECK TM ENZYME ACTIVITY TEST KIT|MCL|CH|||N|10/02/1987|08/14/1990|90M-0327|11/23/1990|APPR|
P870062||LAMBERTS DALSTON LTD.|DALSTON HOUSE, HASTINGS ST.||LUTON, BEDS.||LU1 5||CAP, CERVICAL, CONTRACEPTIVE|PRENTIF TM CAVITY RIM CERVICAL CAP|LLQ|OB|||N|10/05/1987|05/23/1988|88M-0212|07/19/1988|APPR|
P870069||UDL LABORATORIES, INC.|12720 DAIRY ASHFORD||SUGAR LAND|TX|77478||Dressing, wound, drug|BIOBRANE(R) II|FRO|SU|||N|11/12/1987|10/20/1989|89M-0491|12/06/1989|APWD|
P870072||THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|||N|11/24/1987|12/20/1995|97M-0136|04/11/1997|APPR|INTENDED AS A BRIDGE TO CARDIAC TRANSPLANTATION FOR USE IN PATIENTS SUFFERING FROM END-STAGE HEART FAILURE. THE PATIENT SHOULD MEET ALL OF THE FOLLOWING CRITERIA: 1)CANDIDATE FOR CARDIAC TRANSPLANTATION, 2) IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, AND 3) DEPENDENCE O N, OR INCOMPLETE RESPONSE TO, CONTINUE VASOPRESSOR SUPPORT
P870073||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|11/18/1987|03/31/1989|89M-0136|01/19/1990|APWD|
P870076||Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE RING BAND AND APPLICATOR SYSTEMS|KNH|OB|||N|12/07/1987|09/29/1993|93M-0381|11/10/1993|APPR|
P870077||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|DYE|CV|||N|12/07/1987|09/25/1991|91M-0410|11/12/1991|APPR|Approval for the Carpentier-Edwards® Duraflex™ Bioprosthesis, Models 6625 LP and 6625-ESR-LP.   These devices are intended for use in patients whose mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one.  It is also intended for use in patients with a previously implanted mitral valve prosthesis which is no longer functioning adequately and requires replacement.
P870078||MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS|DYE|CV|||N|12/08/1987|09/28/1989|89M-0426|10/27/1989|APPR|
P870080||RICHARD WOLF MEDICAL INSTRUMENTS CORP.|353 CORPORATE WOODS PKWY.||VERNON HILLS|IL|60061||Laparoscopic contraceptive tubal occlusion device|HULKA CLIP FOR TUBAL OCCLUSION|KNH|OB|||N|12/30/1987|09/05/1996|97M-0123|04/02/1997|APWD|APPROVAL FOR THE HULKA CLIP TUBAL OCCLUSION DEVICE AND APPLICATOR SYSTEMS
P880003||CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETER|LOX|CV|||N|02/02/1988|10/28/1988|88M-0383|02/07/1989|APRL|
P880006||St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM|DXY|CV|||N|02/05/1988|02/28/1989|89M-0089|04/18/1989|APPR|
P880009||QIAGEN, INC.|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT|MAQ|MI|||N|02/17/1988|12/23/1988|88M-0446|02/28/1989|APWD|
P880010||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|||N|02/16/1988|10/05/1988|88M-0362|11/30/1988|APWD|
P880011||EDAP INTERNATIONAL CORP.|TWO BURLINGTON WOODS||BURLINGTON|MA|01803||Lithotriptor, extracorporeal shock-wave,urological|TECHNOMED INTERNATIONAL SONOLITH 2000|LNS|GU|||N|02/18/1988|06/23/1989|89M-0211|07/19/1989|APRL|
P880013||NELLCOR PURITAN BENNETT, INC.|2200 FARADAY AVE.||CARLSBAD|CA|92008|7208|VENTILATOR, HIGH FREQUENCY|INFANT STAR HIGH FREQUENCY VENTILATOR|LSZ|AN|||N|02/23/1988|01/19/1990|90M-0069|03/16/1990|APWD|
P880016||ONCOR, INC.|209 PERRY PKWY.||GAITHERSBURG|MD|20877||Dna-probe, b and t lymphocyte|ONCOR B/T GENE REARRANGEMENT TEST|MAM|HE|||N|03/01/1988|10/10/1989|89M-0456|11/14/1989|APPR|
P880026||Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA AP6C-2|ABBOTT PARK|IL|60064|3500|KIT, ASSAY, ESTROGEN RECEPTOR|ABBOTT ER-ICA MONOCLONAL|LPJ|CH|||N|04/04/1988|09/30/1988|88M-0352|12/02/1988|APWD|
P880027||BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC TM (PTCA) CATHETER|LOX|CV|||N|04/07/1988|04/14/1989|89M-0143|05/19/1989|APWD|
P880028||Hospira, Inc.|275 NORTH FIELD DR.|DEPT. 389, BLDG. H2-2|LAKE FOREST|IL|60045||FLUID, HYSTEROSCOPY|DEXTRAN HM 32%|LTA|OB|||N|04/12/1988|05/30/1989|89M-0194|06/29/1989|APWD|
P880029||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|||N|04/14/1988|04/29/1988|88M-0188|07/19/1988|APWD|
P880031||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|VITRAX   SODIUM HYALURONATE|LZP|OP|||N|04/18/1988|08/10/1989|89M-0344|09/13/1989|APWD|
P880032||Bio-Rad|4000 ALFRED NOBEL DR.||HERCULES|CA|94547|1803|HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE|BIO-RAD CYCLOSPORINE BY HPLC TEST|MGS|CH|||N|04/21/1988|07/24/1989|89M-0321|08/22/1989|APRL|
P880038||St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META-MV,PACING SYSTEM|DXY|CV|||N|05/17/1988|04/07/1989|89M-0137|05/17/1989|APWD|
P880040||PIERCE BIOTECHNOLOGY, INC.|3747 NORTH MERIDIAN RD.|P.O. BOX 117|ROCKFORD|IL|60115||ASSAY, INTERLEUKIN|CELLFREE INTERLEUKIN-2RECEPTOR ASSAY KIT|MAN|IM|||N|05/31/1988|10/06/1989|89M-0455|11/14/1989|APWD|
P880042||EDAP INTERNATIONAL CORP.|179 SIDNEY ST.||CAMBRIDGE|MA|02139||Lithotriptor, extracorporeal shock-wave,urological|EDAP LT.01 SHOCK WAVE LITHOTRIPTER|LNS|GU|||N|06/02/1988|12/12/1991|91M-0507|01/15/1992|APWD|
P880045||OSI PHARMACEUTICALS, INC.|1 BIOSCIENCE PARK DRIVE||FARMINGDALE|NY|11735||DNA-PROBE, HUMAN CHROMOSOME|OSI TRANSPROBE-1|MAO|PA|||N|06/21/1988|10/03/1989|89M-0457|11/14/1989|APWD|
P880047||ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED TC7  ABSORBABLE ADHESION BARRIER|MCN|OB|||N|06/27/1988|09/15/1989|89M-0407|10/19/1989|APPR|
P880055||Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CORONARY BALLOON DILATATION CATHETER|LOX|CV|||N|07/18/1988|09/26/1990|90M-0437|01/16/1991|APWD|
P880062||LABTHERMICS TECHNOLOGIES, INC.|701 DEVONSHIRE DR., BLDG. B-1||CHAMPAIGN|IL|61820||Applicator, hyperthermia, deep heating, ultrasound|SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM|LNB|RA|||N|08/08/1988|09/29/1989|89M-0449|11/14/1989|APPR|
P880064||MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||Applicator, hyperthermia, superficial, rf/microwave|HYPERTHERMIA SYSTEM 100 A|LNC|RA|||N|08/12/1988|11/17/1989|90M-0058|03/08/1990|APPR|
P880065||Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER|LOX|CV|||N|08/19/1988|09/19/1990|90M-0319|10/23/1990|APWD|
P880070||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|||N|09/30/1988|09/20/1989|89M-0408|10/19/1989|APWD|
P880072||EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL|HQL|OP|||N|10/07/1988|09/22/1989|||APPR|
P880078||COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VH8500 HYPERTHERMIA TREATMENT SYSTEM|LMZ|RA|||N|10/31/1988|10/17/1989|89M-0461|11/17/1989|APWD|
P880081||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|11/07/1988|10/31/1989|89M-0475|11/27/1989|APPR|
P880082||EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES|HQL|OP|||N|11/08/1988|06/13/1990|90M-0210|07/10/1990|APPR|
P880085||ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 405 SPANFLEX TM IOL|HQL|OP|||N|11/15/1988|06/27/1991|91M-0247|08/02/1991|APWD|
P880086||St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS|DXY|CV|||N|11/15/1988|08/21/1989|89M-0363|09/13/1989|APPR|
P880087||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7U|HQL|OP|||N|11/15/1988|01/31/1990|90M-0054|02/27/1990|APPR|
P880089||INTL. MANAGEMENT SERVICES, INC.|362 SOUTH AVE.||NEW CANAAN|CT|06840||POWDER, DUSTING, SURGICAL|AGENASORB|KGP|HO|||N|11/18/1988|09/13/1990|90M-0312|10/23/1990|APPR|
P880090||Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|||N|11/14/1988|12/28/1989|90M-0005|01/30/1990|APPR|
P880091||STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIC UVA PC IOL.|HQL|OP|||N|12/07/1988|09/16/1991|91M-0380|11/12/1991|APPR|
P880094||ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Suture, nonabsorbable, synthetic, polyester|DACRON SURGICAL SUTURES|GAS|SU|||N|12/12/1988|09/22/1989|||APRL|
P880098||MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lens,contact(rigid gas permeable)-extended wear|MENICON SF-P RGP (MELAFOCON A) CONTACT LENS|MWL|OP|||N|12/16/1988|09/01/1989|89M-0388|10/19/1989|APWD|
P890001||LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR,INC. MODELS 1|LOX|CV|||N|02/09/1989|03/30/1990|90M-0142||APPR|
P890002||ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|POLYPROPYLENE SURGICAL SUTURE|GAW|SU|||N|01/06/1989|05/31/1989|89M-0197|06/29/1989|APRL|
P890003||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SYNERGYST  II PULSE GENERATOR MODELS 7070 & 7071|NVZ|CV|||N|01/05/1989|08/24/1989|89M-0369|09/19/1989|APPR|Approval for the Synergyst™ II Models 7070 and 7071 Pulse Generators and the Model 9710 Programmer with the Model 9739A MemoryMod®.  This device is indicated for cardiac pacing.
P890012||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SIGNATURE CONTACT LENS|LPL|OP|||N|03/03/1989|09/15/1989|89M-0463|11/27/1989|APWD|
P890013||RICHARD WOLF MEDICAL INSTRUMENTS CORP.|353 CORPORATE WOODS PKWY.||VERNON HILLS|IL|60061||Lithotriptor, extracorporeal shock-wave,urological|RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300|LNS|GU|||N|03/07/1989|09/09/1991|91M-0368|10/10/1991|APRL|
P890014||DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|HA-IGMK AND ETI-HA-IGMK|LOL|MI|||N|03/10/1989|07/24/1990|90M-0251|08/10/1990|APRL|
P890017||CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLOON EXPANDABLE STENT|MAF|CV|||N|03/13/1989|09/27/1991|91M-0398|11/14/1991|APPR|
P890019||DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|AB -HAVK|LOL|MI|||N|03/15/1989|07/13/1990|90m-0245|10/01/1990|APRL|
P890020||CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens,contact(rigid gas permeable)-extended wear|FLUOROCON TM-60|MWL|OP|||N|03/20/1989|06/23/1989|89M-0313|08/24/1989|APWD|
P890023||THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|H55 HYDROPHILIC CONTACT LENS|LPM|OP|||N|04/03/1989|09/19/1989|89M-0472|11/27/1989|APPR|
P890024||SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.|15 KIT ST.||KEENE|NH|03431||CATHETER, SAMPLING, CHORIONIC VILLUS|TROPHOCAN TM|LLX|OB|||N|04/06/1989|08/09/1990|90M-0316|10/23/1990|APWD|
P890025||Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TD CYCLOSPORINE AND METABOLITES SERUM ASSAY|MGU|TX|||N|04/10/1989|12/14/1989|89M-0523|01/19/1990|APRL|
P890027||Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN|MCM|EN|||N|05/15/1989|06/27/1990|90m-0222|07/27/1990|APPR|
P890029||CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|EXCELENS (ATLAFILCON A) CONTACT LENS|LPL|OP|||N|05/03/1989|12/28/1989|90M-0006|01/30/1990|APWD|
P890032||CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS STEERABLE PTCA BALLOON CATHETER|LOX|CV|||N|01/31/1989|03/06/1990|90M-0102|02/03/1990|APWD|
P890034||Covidien|6135 GUNBARREL AVE.||BOULDER|CO|80301||VENTILATOR, HIGH FREQUENCY|MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR|LSZ|AN|||Y|06/05/1989|12/13/1991|91M-0508||APWD|
P890039||CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MASTRO SAVVI SERIES 300 VDD PACING SYSTEM|DXY|CV|||N|07/19/1989|09/25/1990|90m-0333|11/02/1990|APPR|
P890040||Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS|LPM|OP|||N|07/18/1989|09/28/1989|89M-0437|11/03/1989|APPR|
P890043||ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|||N|08/18/1989|09/14/1990|90M-0318|10/19/1990|APWD|
P890045||CARBOMEDICS, INC.|1300-D EAST ANDERSON LN.||AUSTIN|TX|78752||GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE|GELSEAL TM TRIAXIAL VASCULAR GRAFT|MAL|CV|||N|08/21/1989|01/11/1993|93M-0023|05/03/1993|APRL|
P890047||Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC(TM)VISCOELASTIC PREPARATION|LZP|OP|||N|08/23/1989|09/26/1991|91M-0394|10/31/1991|APPR|
P890048||USCI, DIV. C.R. BARD, INC.|1200 TECHNOLOGY PARK DR.|P.O. BOX 7025|BILLERICA|MA|01821||Catheters, transluminal coronary angioplasty, percutaneous|USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM|LOX|CV|||N|08/29/1989|04/17/1991|91M-0157|06/06/1991|APRL|
P890049||LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|FINISHED METHAFILCON A CONTACT LENSES|LPM|OP|||N|07/19/1989|09/28/1989|||APWD|
P890055||CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|||N|09/28/1989|03/11/1996|96M-0239|07/16/1996|APPR|APPROVAL FOR MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP
P890056||ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|||N|10/02/1989|05/26/1994|94M-0213|07/18/1994|APWD|
P890057||CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR|LSZ|AN|||N|10/04/1989|03/29/1991|91M-0142|04/25/1991|APPR|
P890061||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE|LWS|CV|||N|11/27/1989|05/02/1991|91M-0184|06/13/1991|APPR|
P890063||MATRIA HEALTHCARE, INC.|1850 PARKWAY PLACE|SUITE 1200|MARIETTA|GA|30067||MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)|GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM|HFM|OB|||N|11/15/1989|09/12/1990|90M-0315|10/23/1990|APRL|
P890064||QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT|MAQ|MI|||N|11/17/1989|03/11/1991|91M-0108|04/10/1991|APPR|
P890065||DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|RADIOIMMUNOASSAY FOR CYCLOSPORINE|CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS|MGV|TX|||N|11/17/1989|09/28/1990|90M-0444|11/02/1990|APRL|
P890066||FOCUS SURGERY, INC.|1565 BARBER LN.||MILPITAS|CA|95035||Lithotriptor, extracorporeal shock-wave,urological|THERASONIC LITHOTRIPSY TREATMENT SYSTEM|LNS|GU|||N|12/07/1989|12/20/1991|||APWD|
P890068||CHIRON OPHTHALMICS|9342 JERONIMO RD.||IRVINE|CA|92718||intraocular lens|MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL|HQL|OP|||N|12/13/1989|01/11/1990|||APPR|
P890070||GRAIN PROCESSING CORP.|1600 OREGON ST.||MUSCATINE|IA|52761||POWDER, DUSTING, SURGICAL|PURE-DENT (R)|KGP|HO|||N|12/20/1989|08/10/1990|90M-0273|10/01/1990|APWD|
P900007||Cook Incorporated|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||CATHETER, SAMPLING, CHORIONIC VILLUS|COOK CHORIONIC VILLUS SAMPLING SET|LLX|OB|||N|02/01/1990|09/30/1994|94M-0364|11/14/1994|APPR|
P900009||BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, bone growth, non-invasive|SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A|LOF|OR|||N|02/01/1990|10/05/1994|94M-0363|11/09/1994|APPR|
P900013||Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK,|IL|60064|3537|KIT, ASSAY, PROGESTERONE RECEPTOR|ABBOTT PGR-EIA MONOCLONAL|LPI|CH|||N|02/16/1990|09/06/1990|90m-0299|10/23/1990|APWD|
P900016||TATE & LYLE|2200 EAST ELDORADO STREET||DECATUR|IL|62525||POWDER, DUSTING, SURGICAL|MIRA-FLO STARCH|KGP|HO|||N|03/01/1990|06/17/1991|91M-0243||APWD|
P900022||SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|CHORUS DDD PACEMAKER|LWP|CV|||N|04/06/1990|09/06/1991|91M-0367|10/31/1991|APPR|
P900023||ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|||N|04/06/1990|11/20/1992|92M-0477|07/02/1993|APPR|
P900025||ZEUS SCIENTIFIC, INC.|200 EVANS WAY||BRANCHBURG|NJ|08876||KIT, ASSAY, PROGESTERONE RECEPTOR|FLUORO-CEP (R) PROGESTERONE|LPI|CH|||N|04/11/1990|09/26/1990|90M-0442|11/23/1990|APWD|
P900030||Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT|LNM|GU|||N|04/27/1990|09/30/1993|||APWD|Approval for the Contigen™ Bard® Collagen Implant.  This device is indicated for use in the treatment of urinary incontinence due to intrinsic sphincter deficiency (poor or non-functioning bladder outlet mechanism) that may be helped by a locally injected bulking agent.  Contigen implant therapy is intended only for patients who have shown no improvement in their incontinence for at least 12 months.
P900032||SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|AIS EXIMER LASER ANGIOPLASTY|LPC|CV|||N|05/02/1990|01/31/1992|92M-0078|03/16/1992|APWD|
P900033||Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||Dressing, wound and burn, interactive|INTEGRA DERMAL REGENERATION TEMPLATE|MGR|SU|||N|05/07/1990|03/01/1996|96M-0203|07/18/1996|APPR|APPROVAL FOR THE INTEGRA ARTIFICAL SKIN
P900037||MEDICAL DEVELOPMENT RESEARCH, INC.|2540 118TH AVE. N.||ST. PETERSBURG|FL|33716||intraocular lens|MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS|HQL|OP|||N|05/15/1990|02/28/1991|91M-0088|04/02/1991|APPR|
P900038||SIGMEDICS, INC.|335 NORTH BROAD ST.||FAIRBORN|OH|45324||STIMULATOR, FUNCTIONAL WALKING NEUROMUSCULAR, NON-INVASIVE|PARASTEP-I|MKD|NE|||N|05/21/1990|04/20/1994|94M-0180|06/14/1994|APPR|
P900039||NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE|MBS|OR|||N|05/25/1990|05/28/1993|93M-0210|07/22/1993|APRL|
P900042||AMERICAN DRUG SCREENS, INC.|1101-A SOVEREIGN ROW||OKLAHOMA CITY|OK|73108||TEST SYSTEM, FOR DRUGS OF ABUSE|AWARE TEST SYSTEM|MGX|CH|||N|06/15/1990|01/18/1994|94M-0067|04/19/1994|APPR|
P900043||CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT|MAF|CV|||N|06/21/1990|08/02/1994|97M-0166|07/10/1997|APWD|
P900048||STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM|HQL|OP|||N|07/02/1990|09/17/1991|91M-0376|10/11/1991|APPR|
P900050||QUEST TECHNOLOGIES CORP.|766 PALOMAR AVE.||SUNNYVALE|CA|94086|9716|Wheelchair, stair climbing|ACCESS MOBILITY SYSTEM|IMK|SU|||N|07/03/1990|06/27/1991|91M-0258|08/15/1991|APPR|
P900052||SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM|LNY|HO|||N|07/19/1990|04/22/1991|91M-0167|06/07/1991|APPR|
P900053||VISION TECHNOLOGIES INTL., INC.|102 SOUTH TEJON|SUITE 1100|COLORADO SPRINGS|CO|80903||intraocular lens|MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR|HQL|OP|||N|08/07/1990|02/28/1991|91M-0089|02/28/1991|APPR|
P900056||Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|||N|08/28/1990|05/28/1993|93M-0208|07/16/1993|APPR|
P900060||SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|||N|09/24/1990|09/29/1993|93M-0383|11/09/1993|APPR|
P900061||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM|LWS|CV|||N|09/28/1990|02/11/1993|93M-0083|04/05/1993|APPR|
P900066||AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|PERFLUOROPROPANE|LPO|OP|||N|11/02/1990|02/25/1993|93M-0097|04/14/1993|APPR|
P900067||AIR LIQUIDE|6141 EASTON ROAD|P.O. BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|SULFUR HEXAFLUORIDE|LPO|OP|||N|11/02/1990|02/25/1993|93M-0096|04/14/1993|APPR|
P900070||ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACING SYSTEM|DXY|CV|||N|11/29/1990|01/30/1992|92m-0054|02/24/1992|APWD|
P910001||SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|||N|02/08/1991|02/19/1993|93M-0086|03/24/1993|APPR|APPROVAL FOR THE SPECTRANETICS CVX-300(TM) EXCIMER LASER SYSTEM, INCLUDING THE MODELS PC1014 AND PC1017 LASER CATHETERS. THIS SYSTEM IS INDICATED FOR USE IN PATIENTS WITH SINGLE OR MULTIVESSEL CORONARY ARTERY DISEASE EITHER AS A STAND ALONE MODALITY OR IN CONJUNCTION WITH PERCUTANEOUS TRANSLUMINAL CORONARY BALLOON ANGIOPLASTY (PTCA) AND WHO ARE ACCEPTABLE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. ADJUNCTIVE BALLOON ANGIOPLASTY WAS PERFORMED, AT THE CLINICAL INVESTIGATOR'S DISCRETION, IN 84 PERCENT OF THE LESIONS TREATED. CLINICAL EXPERIENCE HAS PROVIDED REASONABLE ASSURANCE THAT THE SPECTRANETICICS CVX-300(TM) EXCIMER LASER SYSTEM AND MULTIFIBER LASER CATHETERS ARE SAFE AND EFFECTIVE FOR THE FOLLOWING INDICATIONS:OCCLUDED SAPHENOUS VEIN BYPASS GRAFTS; OSTIAL LESIONS; LONG LESIONS (GREATER THAN 20 MM IN LENGTH); MODERATELY CALCIFIED STENOSES (HEAVILY CALCIFIED STENOSES ARE THOSE LESIONS THAT DEMONSTRATE COMPLETE CALCIFICATION WHEN IDENTIFIED UNDER FLUOROSCOPY PRIOR TO THE PROCEDURE. MODERATELY AND SLIGHTLY CALCIFIED STENOSES ARE ALL OTHERS.); TOTAL OCCLUSIONS TRAVERSABLE BY A GUIDEWIRE; AND LESIONS WHICH HAVE PREVIOUSLY FAILED BALLOON ANGIOPLASTY (THIS INCLUDES THOSE LESIONS THAT WERE TREATED UNSUCCESSFULLY BY PTCA. LESIONS THAT HAVE UNDERGONE A COMPLICATED PTCA PROCEDURE ARE NOT INCLUDED IN THIS CATEGORY.)  THESE LESIONS MUST BE TRAVERSABLE BY A GUIDEWIRE AND COMPOSED OF ATHERSCLEROTIC PLAQUE AND/OR CALCIFIED MATERIAL. THE LESIONS SHOULD BE WELL DEFINED BY ANGIOGRAPHY.
P910007||Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|AXSYM TOTAL PSA & ARCHITECT TOTAL PSA|MTF|IM|||N|03/01/1991|09/25/1991|91M-0411|11/12/1991|APPR|
P910016||DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NRA|OR|||N|03/25/1991|10/30/1992|92M-0446|04/26/1993|APWD|
P910018||KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).|MMY|GU|||N|03/26/1991|02/21/1996|96M-0193|07/01/1996|APPR|APPROVAL FOR THE LIPOSORBER LA-15 SYSTEM. THE DEVICE IS A LOW DENSITY LIPOPROTEIN (LDL) APHERESIS SYTEM
P910019||INTENSIVE TECHNOLOGY, INC.|3574 RUFFIN RD.||SAN DIEGO|CA|92123||CATHETER, CORONARY, ATHERECTOMY|IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)|MCX|CV|||N|03/29/1991|05/18/1993|93M-0209|07/27/1993|APWD|
P910020||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS|DXY|CV|||N|04/11/1991|06/15/1992|n2M-0263|08/07/1992|APWD|
P910023||St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|||N|04/23/1991|04/30/1993|93M-0216|07/22/1993|APPR|Approval for the Cadence® Tiered Therapy Defibrillator System.  This device is indicated for use in patients with a history of hemodynamically compromising ventricular tachyarrhythmias.  These patients may have experienced a cardiac arrest not associated with acute myocardial infarction or have ventricular tacharrhythmias.  In addition, the Cadence® can be used in patients whose primary therapy for hemodynamically significant, sustained ventricular tachycardia is antitachycardia pacing; the defibrillation capabilities of the device provide high energy therapy in the event that the arrhythmia accelerates.  The Cadence® is intended for use with the defibrillation lead systems with which it has been tested:  Ventritex epicardial defibrillation leads, and commercially available CPI defibrillation patch leads and superior vena cava (SVC) spring leads.  When used with the CPI patch lead or SVC leads, the Cadence® is intended for use as a replacement for CPI automatic implantable cardioverter defibrillators.
P910030||COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||STENT, CORONARY|GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)|MAF|CV|||N|06/06/1991|02/08/1993|93M-0212|07/22/1993|APWD|
P910031||ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|ORACLE(TM) CORONARY BALLOON DILATATION CATHETER|LOX|CV|||N|06/07/1991|09/30/1994|94M-0402|12/15/1994|APRL|
P910054||Toray Industries (America), Inc.|461 FIFTH AVENUE, 9TH FLOOR||NEW YORK|NY|10017||CATHETER, PERCUTANEOUS (VALVULOPLASTY)|INOUE BALLOON CATHETER|MAD|CV|||N|09/09/1991|06/28/1994|94M-0269|08/25/1994|APPR|
P910056||Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|||N|09/18/1991|01/17/1992|92M-0047|02/18/1992|APPR|
P910058||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHIROFLEX MODELS 32 C10XX SILICONE POSTERIOR IOL|HQL|OP|||N|09/23/1991|01/17/1992|92M-0046|02/18/1992|APWD|
P910061||BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS|HQL|OP|||N|10/08/1991|09/02/1994|94M-0339|10/14/1994|APPR|
P910062||AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX MODELB/MODEL C EXCIMER LASER SYSTEM|LZS|OP|||N|10/16/1991|09/29/1995|96M-0486|12/23/1996|APPR|APPROVAL FOR VISX EXCIMER LASER SYSTEM (MODELS B & C)
P910063||MATRIA HEALTHCARE, INC.|1850 PARKWAY PLACE|SUITE 1200|MARIETTA|GA|30067||HOME UTERINE ACTIVITY MONITOR|CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM|LQK|OB|||N|10/21/1991|09/29/1995|96M-0255|10/18/1996|APRL|APPROVAL FOR CAREFONE HOME UTERINE ACTIVITY MONITORING SYSTE, MODEL 2001
P910064||THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|F C FEMALE CONDOM|MBU|OB|||N|10/29/1991|05/07/1993|93M-0186|09/01/1993|APWD|
P910065||TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|AIA-PACK PSA|MTF|IM|||N|11/13/1991|07/07/1993|93M-0251|08/10/1993|APPR|
P910066||DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR|LOF|OR|||N|11/18/1991|03/04/1994|94M-0128|05/20/1994|APPR|
P910067||SUMMIT TECHNOLOGY, INC.|21 HICKORY DR.||WALTHAM|MA|02154||Excimer laser system|EXCIMED(TM) UV200LA LASER SYSTEM|LZS|OP|||N|11/20/1991|03/10/1995|95M-0179|07/06/1995|APWD|
P910068||AIR PRODUCTS & CHEMICALS, INC.|7201 HAMILTON BLVD.||ALLENTOWN|PA|18951|501|Fluid, intraocular|VITREON(R)|LWL|OP|||Y|12/06/1991|09/30/1997|97M-0519|01/02/1998|APWD|Approval for VITREON(R) (Perfluorophenanthrene) Intraocular Fluid.  This device is indicated for use as an intraoperative surgical aid during vitreoretinal surgery inpatients with primary and recurrent complicated reinal detachments.  Complicated cases include giant retinal tear or retinal dialysis, proliferative vitreoretinopathy, proliferative diabetic reinopathy, tractional retinal detachments, and blunt or penetrating ocular trauma.  We are pleased to inform you that the PMA is approved for a single batch (Batch #672-45-0001) of the finished product packaged in sterile 6 mL vials.
P910071||BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATOMED SILICONE OIL OP5000|LWL|OP|||Y|12/16/1991|11/04/1994|95M-0180|07/20/1995|APPR|
P910073||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD SYSTEM|LWS|CV|||N|12/19/1991|08/26/1993|94M-0064|04/19/1994|APPR|Approval for the 0060 Series ENDOTAK® Lead System.  The ENDOTAK® Lead System (hereafter referred to as the ENDOTAK® Lead System) consists of the following:   the ENDOTAK® C Lead Models 0060, 0062, 0064; Lead Stylet Models 6824 and 6825;  ENDOTAK® SQ Patch Lead Model 0063; commercially available AICD™ Y Connector Model 6836; and Model 0056 Bipolar Positive Fixation Lead and Adapter.  The ENDOTAK® Lead System is used with commercially available AICD™ Models 15050, 1555, and 1600.  The ENDOTAK® Lead System is a transvenous defibrillation leads system and is intended for the treatment of ventricular tacharrhythmias in patients who are at high risk of sudden cardiac death.   Such patients are defined as those who have experienced one or more of the following:  (1) survived at least one episode of cardiac arrest presumable due to hemodynamically unstable ventricular tachyarrhythmias unassociated with acute myocardial infarction; or (2) recurrent ventricular tachyarrhythmia’s in the absence of such previous arrest and are inducible into sustained hypotensive ventricular tachycardia (VT) or ventricular fibrillation (VF) despite conventional antiarrhythmic drug therapy.A major consideration in choosing the ENDOTAK® Lead System is that it does not require a thoracotomy.  The physician should weigh its advantages against the patient’s ability to withstand additional electrophysiological (EP) testing (arrhythmia induction and conversion testing), and a possible thoracotomy, should the lead system prove ineffective.Various factors such as cardiomegaly or drug therapy may necessitate repositioning of the defibrillating leads, or substitution of one lead system for another in order to facilitate arrhythmia conversion.  In some cases, reliable arrhythmia conversion may not be obtained with any leads at the available AICD™ energy levels.Bipolar pacmakers may be used with the ENDOTAK® Lead System and AICD™ pulse generator as long as the pacemaker and AICD™ pulse generator do not interact causing AICD™ pulse generator nondetection or false detection.The ENDOTAK® SQ Patch Lead is intended for chronic subcutaneous or submuscular implantation in conjunction with an ENDOTAK® C Lead.  The ENDOTAK® SQ Patch Leas is not intended for epicardial or pericardial placement.
P910077||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR|LWS|CV|||N|12/23/1991|06/17/1994|94M-0241|08/15/1994|APPR|
P920004||St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (TM)|MGB|CV|||N|02/03/1992|09/29/1995|95m-0394|12/15/1995|APWD|APPROVAL FOR THE VASOSEAL VASCULAR HEMOSTASIS DEVICE (VHD) IN ADDITION TO INDICATION ALREADY MENTIONED ALSO INDICATED FOR USE IN PTCA PATIENTS WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED
P920006||Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|KIT, ASSAY, PROGESTERONE RECEPTOR|IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE|LPI|CH|||N|02/06/1992|09/26/1995|96M-0219|07/12/1996|APWD|APPROVAL FOR THE ABBOTT PGR-ICA MONOCLONAL
P920011||ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||permanent pacemaker Electrode|MAXIM PFS MODEL 033-301|DTB|CV|||N|03/17/1992|11/07/1996|97M-0275|07/08/1997|APWD|APPROVAL FOR THE MAXIM(TM)(PFS) MODEL 033-301 PACING LEAD. THIS DEVICE IS INTENDED FOR CHRONIC PACING AND SENSING OF THE VENTRICLE WHEN USED WITH A COMNPATIBLE PULSE GENERATOR
P920014||THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE VE LVAS|DSQ|CV|||N|03/30/1992|09/30/1994|94M-0404|10/03/1996|APWD|APPROVAL FOR THE HEARTMATE (R) IP LVAS
P920015||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC(R) TRANSVENE LEAD SYSTEM|NVY|CV|||Y|04/01/1992|12/09/1993|94M-0063|04/19/1994|APPR|Approval for the Medtronic Transvene® Lead System.  This device is intended for single long-term use and each lead is designed to be used only with a compatible Medtronic implantable tachyarrhytmia control device along with at least one other Medtronic defibrillation lead.  The lead system has application where implantable e tachyarrhythmia cardioversion or defibrillation systems are indicated.  Current medical research indicates that such patients should:  (1) have survived at least one episode of a cardiac arrest presumably due to a ventricular tachyarrhythmia as evidenced by resuscitation using a transthoracic defibrillator.  The ventricular tachyarrhythmia should not be caused by an acute myocardial infarction; or (2) in the absence of a of a prior cardiac arrest, have poorly tolerated sustained VT and/or VF, which occurs spontaneously, or can be induced, despite the best antiarrhythmic drug therapy.The natural history of patients with hemodynamically stable sustained VT is not well defined.  While this patient population was included in the Transvene® Lead clinical study, no conclusions were drawn from the data obtained on this specific patient group.Prior to Transvene® implant, it is strongly recommended that patients undergo a complete cardiac evaluation, which should include extensive electrophysiologic testing.  Also, extensive electrophysiologic evaluation and testing of the safety and efficacy of the proposed pacing, cardioversion, or defibrillation therapies are recommended during and after the implantation of the Transvene® System.
P920023||Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESIS|MES|GU|||N|05/12/1992|05/06/1996|96M-0356|10/09/1996|APWD|APPROVAL FOR THE UROLUME ENDORETHRAL PROSTHESIS FOR URETHRAL STRICTURES (REFERRED TO AS UROLUME HEREINAFTER)
P920027||C.R. Bard, Inc.|129 CONCORD RD., BLDG.#4||BILLERICA|MA|01821||GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE|ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II|MAL|CV|||N|06/03/1992|10/21/1994|97M-0203|05/27/1997|APRL|
P920030||BAYER HEALTHCARE, LLC|511 BENEDICT AVE.||TARRYTOWN|NY|10591||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|CIBA CORNING ACS PSA IMMUNOASSAY|LTJ|IM|||N|06/26/1992|12/08/1998|94M-0349|10/27/1994|APWD|
P920031||DADE BEHRING, INC.|PO BOX 6101||NEWARK|DE|19714|6101|CYCLOSPORINE|EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY|MKW|TX|||N|06/29/1992|10/02/1996|97M-0082|03/21/1997|APRL|APPROVAL FOR THE EMIT(R) 2000 CYCLOSPORINE SPECIFIC ASSAY.  THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE ON THE ROCHE DIAGNOSTICS SYSTEMS COBAS MIRA, COBAS MIRA S, AND COBAS MIRA PLUS CHEMISTRY SYSTEMS FOR THE QUANTITATIVE ANALYSIS OF CYCLOSPORINE (CSA) IN HUMAN WHOLE BLOOD AS AN AID IN THE MANAGEMENT OF CYCLOSPORINE THERAPY IN KIDNEY, HEART, AND LIVER TRANSPLANT PATIENTS.
P920032||PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE|MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER|JOQ|CV|||N|06/30/1992|03/10/1994|94M-0129|05/06/1994|APPR|
P920034||MEDIREX, INC.|49 WALNUT PARK||WELLESLEY HILLS|MA|02181||Lithotriptor, extracorporeal shock-wave,urological|TRIPTER-X1 NOVA|LNS|GU|||N|07/09/1992|09/20/1996|96M-0473|12/10/1996|APRL|APPROVAL FOR THE TRIPTER-X1 SERIES EXTRACORPOREAL SHOCK WAVE LITHOTRIPTERS (TRIPTER-X1, TRIPTER-X1 NOVA, AND TRIPTER-X1 COMPACT
P920038||MATRIA HEALTHCARE, INC.|1850 PARKWAY PLACE|SUITE 1200|MARIETTA|GA|30067||HOME UTERINE ACTIVITY MONITOR|SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM|LQK|OB|||N|07/24/1992|09/29/1995|96m-0220|07/18/1996|APRL|APPROVAL FOR SYSTEM 37 HOME UTERINE ACTIVITY MONITOR
P920046||FEMCARE LTD.|STUART COURT, SPURSHOLT PLACE, SALISBURY RD|ROMSEY|HAMPSHIRE||SO516||Laparoscopic contraceptive tubal occlusion device|FILSHIE CLIP (MARK VI) SYSTEM|KNH|OB|||N|09/10/1992|09/05/1996|96M-0463|12/09/1996|APPR|APPROVAL FOR THE FILSHIE CLIP SYSTEM (MARK VI). THE DEVICE IS A CONTRACEPTIVE TUBAL OCCLUSION DEVICE (TOD)
P920047||Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|||N|09/28/1992|10/28/1994|95M-0121|06/07/1995|APPR|
P920048||HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)|LKV|CH|||Y|10/20/1992|09/21/1995|96M-0218|07/08/1996|APPR|
P920051||KARL STORZ ENDOSCOPY-AMERICA, INC.|1201 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|STORZ MODULITH (TM) LITHOTRIPTER|LNS|GU|||N|11/24/1992|02/17/1995|95m-0396|12/15/1995|APRL|STORZ MODULITH LITHOTRIPTER, MODEL SL20 - THE DEVICE IS AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
P930014||Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES|HQL|OP|||N|05/28/1993|12/22/1994|96M-0221|07/15/1996|APPR|Approval for the ACRYSOf® Models MA60BM and MA30BA Ultraviolet-Absorbing Acrylic Foldable UV-Absorbing Posterior Chamber Intraocular Lenses (IOLs).  These devices are indicated for replacement of the human lens to achieve visual correction of aphakia in patients 60 years of age and older when extracapsular cataract extraction or phacoemulsification are performed.  These lenses are intended for placement in the capsular bag.
P930016||AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX EXCIMER LASER SYSTEM MODELS B AND C|LZS|OP|||N|06/15/1993|03/27/1996|97M-0084|03/25/1997|APPR|APPROVAL FOR THE VISX EXCIMER LASER SYSTEM (MODELS B AND C)
P930021||THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|BIORA EMDOGAIN(R)|NQA|DE|||N|07/19/1993|09/30/1996|96M-0482|11/21/1996|APPR|APPROVAL FOR THE EMDOGAIN
P930022||MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR|NVZ|CV|||N|07/21/1993|02/07/1997|97M-0121|04/02/1997|APPR|APPROVAL FOR THE LEGEND PLUS(R) PACING SYSTEM INCLUDING THE LEGEND PLUS(R) PULSE GENERATOR MODELS 8446 AND 8448; THE MODEL 9790 AND 9790C PROGRAMMERS WITH THE MODEL 9891 BASELINE SOFTWARE AND WITH THE MODE 9807 SOFTWARE. THIS SYSTEM IS INDICATED FOR PERMANENT VENTRICULAR OR ATRIAL PACING APPLICATIONS.  ITS USE IS INDICATED IN THE TREATMENT OF PATIENTS WHO MAY BENEFIT FROM A PCING RATE THAT CHAGNES IN RESPONSE TO ACTIVITY.  VENTRICULAR INDICATIONS INCLUDE: 1)CHRONIC ATRIAL FLUTTER OR FIBRILLATION WITH SLOW VENTRICULAR RESPONSE; 2)SINUS NODE DYSFUNCTIONS OR SICK SINUS SYNDROME (E.G., SINUS BRADYCARDIA, SINUS ARREST AND/OR EXIT BLOCK, BRADYCARDIATACHYCARDIA SYNDROME, CHRONOTROPIC INSUFFICIENCY, ETC.,); AND 3)AV BLOCK.  ATRIAL INDICATIONS INCLUDE:1)SINUS NODE DYSFUNCTION OR SICK SINUS SYNDROME (E.G., SINUS BRADYCARDIA, SINUS ARREST AND/OR EXIT BLOCK, BRADYCARDIATACHYCARDIA SYNDROME, ETC.,) WITH INTACT AV CONDUCTION
P930024||LABTICIAN OPHTHALMICS, INC.|2140 WINSTON PARK DR.||OAKVILLE, ONTARIO||L6H 5||Catheter, balloon for retinal reattachment|GRIESHABER SCLERAL BUCKLING BALLOON CATHETER|LOG|OP|||N|03/16/1992|06/02/1994|94M-0229|07/22/1994|APWD|
P930027||SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS|MTF|IM|||N|08/10/1993|09/15/1995|96M-0217|09/12/1996|APPR|APPROVAL FOR THE COAT-A-COUNT PSA IRMA
P930029||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR(TM) RFCA SYSTEM|LPB|CV|||Y|08/26/1993|02/09/1995|95M-0057|04/28/1995|APPR|
P930030||COLETICA S.A.|32 RUE ST., JEAN DE DIEU||LYON||69007||Agent, absorbable hemostatic, collagen based|HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE|LMF|SU|||N|08/30/1993|08/15/1995|95m-0393|12/19/1995|APPR|
P930031||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|||Y|09/20/1993|09/29/1995|96M-0238|07/17/1996|APPR|APPROVAL FOR THE WALLSTENT TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) ENDOPROSTHESIS.
P930034||Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX EXCIMER LASER SYSTEM|LZS|OP|||N|10/12/1993|10/20/1995|96M-0274|08/15/1996|APWD|INDICATED FOR A 6.0 MM ABLATION ZONE, MYOPIC PHOTOREFRACTIVE KERATECTOMY (PRK) IN PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA:1)1.5 TO 7.0 DIOPTERS OF MYOPIA WITH ASTIGMATISM OF <- 1.5 DIOPTERS; 2)REFRACTION IS WITHIN +- 1.0 DIOPTER FOR ONE YEAR PRIOR TOT HE LASER TREATMENT; AND 3) 21 YEARS OF AGE OR OLDER
P930035||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P2 SYSTEM|LWS|CV|||N|08/30/1993|03/10/1995|95M-0072|04/21/1995|APPR|
P930036||SIEMENS HEALTHCARE DIAGNOSTICS INC.|333 CONEY  STREET||EAST WALPOLE|MA|02032||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS|LOK|IM|||N|10/18/1993|09/29/1995|95M-0195|07/03/1996|APPR|APPROVAL FOR THE CIBA CORNING ACS AFP IMMUNOASSAY
P930038||St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|Angio Seal Vascular Closure Device|MGB|CV|||N|10/28/1993|09/30/1996|97M-0259|07/10/1997|APPR|APPROVAL FOR THE ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
P930039||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568|NVN|CV|||N|11/01/1993|03/29/1996|96M-0357|10/08/1996|APPR|
P940001||GENSIA, INC.|9360 TOWNE CENTER DR.||SAN DIEGO|CA|92121||Pump, drug administration, closed loop|GENESA(R) SYSTEM|MQT|HO|||N|01/03/1994|09/12/1997|98M-0136|03/04/1998|APWD|This device indicated for delivering arbutamine, a catecholamine, through a closed-loop, computer-controlled drug-delivery system to elicit acute cardiovascular responses similar to those produced by exercise.  In pts w/suspected coronary artery disease (CAD) who cannot exercise adequately, stress induction with the GenESA(R) System is indicated as an aid in diagnosing the presence or absence of CAD.  The effectiveness of the device has been demonstrate in clinical studies using radionuclide myocardial perfusion imaging to predict the results of coronary angiography.  These studies were in patients with high and lower risks of CAD and utilized blinded, central reading of images.  Estimates of sensitivity, specificity and predictive values are presented in the "Clinical Trilas" section.  Although the effectiveness of the GenESA(R) System was also assessed in similar clinical studies utilizing echocardiography to predict the results of coronary angiography, the blinded, central reading of the images from the lower-risk echocardiography study was technically inadequate.  Estimates of sensitivity, specificity and predictive values, based ont he non-blinded readings of echocardiograms at the local study sites, are presented for the lower-risk patients (see the Clinical Trials section of the GenESA(R) (arbutamine) Package Insert).  For the study of high-risk patients, the estimates are based on valid, blinded, central reading of images.  Like exercise testing, cardiac stress testing with the GenESA(R) System must always be performed under the direct supervision of a physician, and cardiac emergency equipment and supplies (defibrillator, intravenous b-blocker, etc.) must always be available.  Arbutamine must not be administered without use of the GenESA(R) Device.
P940002||SULZERMEDICA|9900 SPECTRUM DR.||AUSTIN,|TX|78717||PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)|MBD|OR|||N|01/14/1994|03/21/1997|97M-0252|06/30/1997|APRL|APPROVAL FOR THE NATURAL-KNEE(R) AND NATURAL KNEE(R) II WITH CSTI(TM).  THESE DEVICES ARE INDICATED FOR UNCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS WITH INTACT MEDIAL AND LATERAL COLLATERAL LIGAMENTS UNDERGOING PRIMARY SURGERY FOR REHABILITATING KNEES DAMAGED AS A RESULT FO NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR INFLAMMATORY JOINT DISEASE (IJD)
P940004||VENTANA MEDICAL SYSTEMS, INC.|1910 EAST INNOVATION PARK DR.||TUCSON|AZ|85755||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI|MVD|PA|||N|02/14/1994|12/30/1997|98M-0712|09/09/1998|APWD|Approval for the Oncor(R) Inform(TM) HER-2/neu Gene Detection System.  The Oncor(R) INFORM(TM) HER-2/neu Gene Detection System is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of HER-2/neu gene amplification on formalin-fixed, paraffin-embedded human breast tissue as an aid to stratify breast cancer patients according to risk for recurrence or disease-related death.  It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priary, invasive, localized breast carcinoma and who are lymph node-negative.
P940005||ADVANCED TECHNOLOGY LABORATORIES, INC.|22100 BOTHELL EVERETT HWY.|P.O. BOX 3003|BOTHELL|WA|98041|3003|System, imaging, pulsed doppler, ultrasonic|ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM|IYN|RA|||Y|02/17/1994|04/11/1996|96M-0450|11/29/1996|APWD|APPROVAL FOR THE ULTRAMARK 9 HIGH DEFINITION IMAGING (HDI) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD
P940007||ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL|HQL|OP|||N|02/28/1994|07/20/1995|95m-0395|12/19/1995|APWD|APPROVAL FOR MODEL WS-100 PLIOLENS ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
P940008||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS|LWS|CV|||N|03/17/1994|11/28/1995|96M-0202|07/10/1996|APWD|APPROVAL APPLICATION (PMA) FOR THE RES-Q ACD (ARRYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS WHICH CONSIST OF THE FOLLOWING:  MODEL 101-01 & 101-01R RES-Q IMPLANTABLE ARRHYTHMIA CONTROL DEVICE; MODEL 531-30 RX2000 GRAPHICS PROGRAM MODULE TO BE USED WITH INTERMEDICS COMMERCIALLY AVAILABLE MODEL 522-06 RX2000 GRAPHICS PROGRAMMER; MODELS 497-05, 497-06, AND 497-09 RIGHT VENTRICULAR (RV) DEFIBRILLATION/PACING LEADS; MODEL 497-15 SUBCUTANEOUS PATCH LEAD; MODEL 497-16 SUPERIOR VENA CAVA (SVC) LEADS; MODELS 497-01, 497-02, 497-11, AND 497-12 EPICARDIAL PATCH LEADS; MODELS A67 AND L67 COMMERCIALLY AVAILABLE CPI EPICARDIAL PATCH LEADS; MODEL 370-01 ADAPTER; MODEL 370-21 Y-ADAPTER; MODEL 370-04 TEST BOX; MODELS 370-03 AND 370-23 PATIENT CABLES; MODEL 370-05 TEST LOAD; MODEL 370-02 ACCESSORY KIT; MODEL 370-10 LEAD CAPS; AND MODELS 370-11, 370-12, 370-13, 370-14, 370-15,370-16, 370-48, AND 370-49 STYLETS.  THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS:  (1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA, OR (2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).
P940009||SCIMED LIFE SYSTEMS, INC.|6655 WEDGWOOD RD.||MAPLE GROVE|MN|55311|3616|Catheters, transluminal coronary angioplasty, percutaneous|PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH|LOX|CV|||N|02/16/1994|09/29/1994|94M-0403|12/15/1994|APRL|
P940010||CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE(TM) FIBER OPTIC DIFFUSER|MVG|SU|||N|04/13/1994|12/27/1995|97M-0204||APPR|APPROVAL FOR OPTIGUIDE FIBER OPTIC DIFFUSER, MODELS DCYL 10, DCYL 15, DCYL 25
P940011||LUMENIS, INC.|3959 WEST 1820 SOUTH||SALT LAKE CITY|UT|84104||SYSTEM, LASER, PHOTODYNAMIC THERAPY|COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS|MVF|SU|||N|04/13/1994|12/27/1995|97M-0204||APWD|APPROVAL FOR THE COHERENT PLD1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
P940012||AMERICAN MEDICAL SYSTEMS, INC.|10700 BREN ROAD WEST||MINNETONKA|MN|55343||SYSTEM, LASER, PHOTODYNAMIC THERAPY|600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS|MVF|SU|||N|04/13/1994|12/27/1995|97M-0204||APWD|APPROVAL FOR THE 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG (OPERATING AT 532 NM) SURGICAL LASERS
P940013||Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|PRECISION(TM) UV (VASURFILCON)|LPM|OP|||N|05/06/1994|09/30/1994|||APWD|FOR THE PRECISION (IV' (VASURFILCON A) HYDROPHILIC CONTACTLENS FOR EXTENDED WEAR. THIS DEVICE IS INDICATED FOR NON-APHAKIC DAILY OREXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING, RINSING, ANDDISINFECTING, AS RECOMMENDED BY THE EYE CARE PRACTITIONER. CANDIDATES TO USETHE PRECISION UV'" HYDROPHILIC CONTACT LENS INCLUDE PERSONS WHO ARE NEARSIGHTED(MYOPIC) AND FARSIGHTED (HYPEROPIC) AND WHO MAY HAVE ASTIGMATISM OF 2.0DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.
P940015||GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC ONE|MOZ|OR|||N|05/31/1994|08/08/1997|98M-0217|04/07/1998|APPR|APPROVAL FOR SYNVISC(R) HYLAN G-F 20.  THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P940016||B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|H.E.L.P. SYSTEM|MMY|GU|||N|06/01/1994|09/19/1997|98M-0138|04/16/1998|APPR|Approval for the H.E.L.P. System.  The device is a low density lipoprotein cholesterol (LDL-C) apheresis system, indicated for use in perofrming LDL-C apheresis to acutely remove LDL-C from the plasma of high risk patient populations for whom diet has been ineffective or not tolerated.
P940019||BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT(R) ILIAC ENDOPROSTHESIS|NIO|CV|||N|06/09/1994|05/28/1996|97M-0054|02/21/1997|APPR|APPROVAL FOR THE 6 MM THROUGH 10 MM DIAMETER WALLSTENT ILIAC ENDOPROSTHESIS
P940022||ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT|MCM|EN|||N|06/30/1994|03/22/1996|96M-0490|12/27/1996|APCB|APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT FOR USE IN AN ADULT POPLUATION
P940024||TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable cardioverter defibrillator (non-CRT)|GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.|LWS|AN|||N|07/08/1994|07/03/1997|97M-0500|12/18/1997|APPR|APPROVAL FOR THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR SYSTEM. THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HEREAFTER REFERRED TO AS THE 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM CONSISTS OF THE FOLLOWING:  THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFBRILLATOR; IMPLANTABLE DEFIBRILLATOR PATCH LEAD MODEL 040-105, 040-106, 040-107, 040-128, 040-129 AND 040-130; MODEL 4510 IMPLANT SUPPORT DEVICE; GENERIC 4211 PERSONALITY MODEULE; AND SYSTEM ACCESSORIES (ADAPTER MODELS 040-051, 040-052, 040-047, 040-055, 033-330, AND 033-320, MODEL 042-018 PATIENT INTERFACE MODULE, MODEL 040-021, STYLET KIT AND CABLE MODELS 042-010, 042-011, 042-015, 042-238 AND 042-017).  THE 4211 SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR FIBRILLATION AND/OR VENTRICULAR TACHYRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATION:  SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS) DUE TO VENTRICULAR TACHYRHYTHMIA OR RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).  NOTE:THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS IS NOT FULLY KNOWN.  SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.
P940029||BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|PAPNET (R) TESTING SYSTEM|MNM|PA|||N|09/21/1994|11/08/1995|96M-0472|12/11/1996|APWD|APPROVAL FOR THE PAPNET TESTING SYSTEM
P940031||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|VIGOR(TM) DR PACEMAKER SYSTEM|DXY|CV|||N|09/30/1994|06/21/1995|96M-0451|11/29/1996|APPR|
P940033||THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|FEMIDOM|MBU|OB|||N|09/30/1994|04/14/1995|95M-0119|06/08/1995|APWD|
P940034||GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|MWA|MI|||Y|07/11/1994|12/15/1995|97M-0184|06/18/1997|APRL|
P940035||ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|MATRITECH NMP22(TM) TEST KIT|NAH|IM|||N|11/07/1994|07/02/1996|96M-0462|12/09/1996|APPR|APPROVAL FOR THE MATRITECH NMP22 TEST KIT. THE MATRITECH NMP22 TEST KIT IS AN ENZYME IMMUNOASSAY (EIA) FOR THE IN VITRO QUANTITATIVE DETERMINATION OF NUCLEAR MATRIX PROTEIN NMP22 IN STABILIZED VOIDED URINE.
N80023||KELLER AND HECKMAN|1001 G STREET, N.W.|SUITE 500 WEST|WASHINGTON|DC|20001|||ABSORBABLE DUSTING POWDER||HO|||N|08/02/1972|08/02/1972|||APWD|
P940036||BARTELS PROGNOSTICS, INC.|2005 NW SAMMAMISH RD.|SUITE 107|ISSAUAH|WA|98027||Test, anti-tumor cell susceptibility|BARTELS CHEMORESPONSE ASSAY|MHR|MI|||Y|11/23/1994|08/01/1996|96M-0471|12/17/1996|APPR|APPROVAL FOR THE BARTELS CHEMORESPONSE ASSAY
P940040||Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST|MWA|MI|||Y|12/22/1994|11/26/1996|97M-0125|04/01/1997|APWD|APPROVAL FOR THE AMPLICOR(R) MYCOBACTERIUM TUBERCULOSIS(MTB) TEST. THE DEVICE IS A TARGET AMPLIFIED IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF M.TUBERCULOSIS COMPLEX DNA IN CONCENTRATED SEDIMENTS PREPARED FROM SPUTUM (INDUCED OR EXPECTORATED), BRONCHIAL SPECIMENS INCLUDING BRONCHOALVEOLAR LAVAGES OR ASPIRATES, OR TRACHEAL ASPIRATES.
P950001||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285|NVN|CV|||N|01/13/1995|05/08/1996|96M-0371|10/24/1996|APPR|APPROVAL FOR THE SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 AND 4285
P950002||Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK INTERBODY FUSION SYSTEM|MAX|OR|||Y|01/17/1995|09/20/1996|96M-0424|11/18/1996|APRL|APPROVAL FOR THE BAK INTERBODY FUSION SYSTEM WITH INSTRUMENTATION.
P950005||CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER|LPB|CV|||N|04/03/1995|09/30/1997|98M-0678|09/08/1998|APPR|Approval for the Cordis Webster Diagnostic/Ablation Deflectable Tip Catheter.  This device includes the following models:  six curve types (A, B, C, D, E, and F); tip electrode (4mm tip large and grooved); connector type [Redel 10-pin connector (temperature sensing version) and Nexus plug (non-temperature-sensing version)]; spacing [standard 2-5-2 spacing (center to center measurement of ring electrode spacing)].  This device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) condution pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia; and, creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.
P950008||ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|||Y|02/22/1995|09/25/1997|97M-0521||APPR|Approval for the SILIKON 1000.  This device is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management.  Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perofrating injuries.  SILIKON 1000 is also indicated for primary use in detachments due to AIDS) related CMV retinitis and other viral infections affecting the retina.
P950009||BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM|MNM|PA|||N|02/24/1995|09/29/1995|96M-0332|09/23/1996|APPR|APPROVAL FOR THE AUTOPAP 300 QC SYSTEM
P950011||BIOMIRA, INC.|30 MERIDIAN ROAD||REXDALE, ONTARIO||M9W 4||ANTIGEN, CANCER 549|TRUQUANT(R) BR(TM) RIA|MJB|IM|||Y|02/28/1995|03/29/1996|96M-0216|07/23/1996|APPR|APPROVAL FOR AN IN VITRO DIAGNOSITC DEVICE (BIOMIRA TRUQUANT BR RIA)
P950014||Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|||Y|04/17/1995|05/03/1996|96M-0358|10/09/1996|APWD|APPROVAL FOR PROSTATRON
P950015||NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION|MNO|CV|||Y|04/18/1995|08/20/1998|99M-2672|08/17/1999|APPR|Approval for The Heart Laser CO2 TMR System.  This device is indicated for the treatment of patients with stable angina (Canadian Cardiovascular Society class 3 or 4) refractory to medical treatment and secondary to objectively demonstarted coronary artery atherosclerosis not amenable to direct coronary revascularization.
P950018||ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)|LWL|OP|||Y|04/28/1995|02/29/1996|96M-0233|07/18/1996|APPR|APPROVAL FOR PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID) THIS DEVICE, A PERFLUOROCARBON LIQUID, IS AN INTRAOPERATIVE TOOL
P950019||STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION|MAX|OR|||Y|06/14/1995|10/29/1996|97M-0052|03/03/1997|APRL|APPROVAL FOR THE RAY THREADED FUSION CAGE (TFC) WITH INSTRUMENTATION
P950020||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|FLEXATOME CUTTING BALLOON|NWX|CV|||N|06/26/1995|04/18/2000|00M-1298||APPR|THIS DEVICE IS INDICATED FOR THE DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.  IN ADDITION, THE TARGET LESION SHOULD POSSESS THE FILLOWING CHARACTERISTICS: DISCRETE (<=15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH) WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.0 MM TO 4.0 MM; READILY ACCESSIBLE TO THE DEVICE; LIGHT TO MODERATE TORTUOSITY OF PROXIMAL VESSEL SEGMENT, NON-ANGULATED LESION SEGMENT (<45 DEGREES), SMOOTH ANGIOGRAPHIC CONTOUR; AND ABSENCE OF ANGIOGRAPHICALLY-VISIBLE THROMBUS AND/OR CALCIFICATION.
P950021||SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY|MTG|IM|||N|06/27/1995|12/22/1995|96M-0200|07/15/1996|APPR|APPROVAL FOR THE TECHNICON IMMUNO 1 PSA ASSAY - THIS DEVICE IS AN IN VITRO DIAGNOSTIC DEVICE
P950022||St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|TVL(TM) LEAD SYSTEM|LWS|CV|||N|06/30/1995|05/10/1996|97M-0460|11/19/1997|APPR|APPROVAL FOR THE VENTRITEX TVL LEAD SYSTEM:TRANSVENOUS RIGHT VENTRICULAR LEAD MODELS RV-1101, RV01, AND RV02; TRANSVENOUS SUPERIOR VENA CAVA LEAD MODELS, SV-1101, SV01, SV02, AND SV03; SUBCUTANEOUS LEAD MODELS, SQ-701 AND SQ01; VEIN PICK MODEL TV-0001; SILICONE LUBRICANT MODEL TV-0013; LEAD TUNNELER KIT MODEL LTK-01; MODEL AC-2481 HIGH VOLTAGE Y-ADAPTER; MODEL AC-CDT-EX VENTRITEX EXTERNAL STIMULATOR ADAPTER; AND TVL LEAD SYSTEM ACCESSORY KIT
P950024||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695|NVN|CV|||N|07/17/1995|09/06/1996|97M-0273|07/08/1997|APPR|APPROVAL FOR THE CAPSURE EPI PACING LEAD, MODEL 4965
P950027||FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN(R)|MOZ|OR|||N|07/28/1995|05/28/1997|98M-0980|12/07/1998|APPR|THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THEKNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY, AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN
P950029||SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER|DXY|CV|||N|08/02/1995|03/10/1997|97M-0185|05/19/1997|APPR|APPROVAL FOR THE CHORUS RM MODEL 7034 DDDR PACEMAKER SYSTEM AND OPUS RM MODEL 4534 SSIR PACEMAKER SYSTEM WHICH INCLUDES AN IBM COMPATIBLE MICROCOMPUTER WHICH HAS BEEN CONFIGURED AND FURNISHED BY ELA MEDICAL, INC. WITH CSO 2.46 PROGRAMMING SOFTWARE AND IS CONNECTED TO A CPR1 PROGRAMMING HEAD.  THESE DEVICES ARE INDICATED FOR:  RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION; AND THE GENERALLY ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: *SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREEE AV BLOCK; *SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; *SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; *BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND *VASO-VAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. THE CHROUS RM IS ALSO INDICATED FOR DUAL-CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.  DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE:  *VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND *VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.
P950032||ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|||Y|10/04/1995|05/22/1998|98M-0992|12/17/1998|APCB|This device is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
P950034||GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE|MCN|SU|||Y|10/27/1995|08/12/1996|97M-0139|04/16/1997|APPR|APPROVAL FOR THE SEPRAFILM BIORESORBABLE MEMBRANE
P950035||BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM(R)|GZC|EN|||N|10/31/1995|08/15/1997|97M-0458|11/14/1997|APPR|Approval for the Freehand System(R).  The system includes: implantable receiver-stimulator Model 202-1, implantable epimysial electrode set Model 203-1, surgical electrode positioning kit Model 207-1, patient external system Model 204-1, programming system Model 209-1.  The system is an upper extremity neuroprosthesis and is intended to improve a patient's ability to grasp, hold, and release objects.  The system is indicated for use in patients who: are tetraplegic due to C5 or C6 spinal cord injury (ASIA Classification); have adequate functional range of motion of the upper extremity; have intact lower motor neuron innervation of hte forearm and hand musculature; and are skeletally mature.
P950037||BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS|DXY|CV|||N|11/16/1995|10/11/1996|97M-0251|07/02/1997|APPR|RATE ADAPTIVE PACING WITH THE DROMOS DR AND DROMOS SR PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY
P950039||HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP(R) PROCESSOR, MODEL TP 2000|MKQ|PA|||N|11/22/1995|05/20/1996|97M-0254|06/30/1997|APPR|APPROVAL FOR THE THINPREP 2000 SYSTEM
P950040||PERSONAL HEALTH & HYGIENE, INC.|2 NORTH CHARLES STREE||BALTIMORE|MD|21201||ENZYME IMMUNOASSAY, CANNABINOIDS|DR. BROWN'S HOME DRUG TESTING KIT|LDJ|TX|||N|12/19/1995|01/21/1997|97M-0257|06/30/1997|APPR|APPROVAL FOR DR. BROWN'S HOME DRUG TESTING SYSTEM. DR. BROWN'S HOME DRUG TESTING SYSTEM IS AN OVER-THE-COUNTER COLLECTION AND TRANSPORT SYSTEM INTENDED FOR USE BY INDIVIDUALS WISHING TO ANONYMOUSLY TEST URINE SAMPLES FOR DRUGS OF ABUSE (MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, PHYENCYCLIDINE (PCP), CODEINE, AND MORPHINE).
P950042||NOVADAQ TECHNOLOGIES, INC.|2585 SKYMARK AVENUE, STE. 306||MISSISSAUGA, ONTARIO||L4W 4||SYSTEM, IMAGING, FLUORESCENCE|PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA|MRK|EN|||N|12/22/1995|09/19/1996|97M-0122|04/01/1997|APPR|APPROVAL FOR THE XILLIX LIFE-LUNG FLUORESCENCE ENDOSCOPY SYSTEM
P950043||MEDISPEC, LTD.|19110 MONTGOMERY VILLAGE AVE.|SUITE 100|MONTGOMERY VILLAGE|MD|20886||Lithotriptor, extracorporeal shock-wave,urological|ECONOLITH(TM) LITHOTRIPTER|LNS|GU|||N|12/26/1995|04/07/1997|97M-0253|07/10/1997|APRL|APPROVAL FOR THE ECONLITH(TM) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER.  THE DEVICE IS INDICATED FOR USE IN THE NON-INVASIVE FRAGMENTATION OF UPPER URINARY TRACT STONES BETWEEN 5 AND 20MM IN SIZE
P960001||DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|DEPUY 1 BONE CEMENT|LOD|OR|||N|01/11/1996|02/11/1997|97M-0255|07/02/1997|APRL|APPROVAL FOR THE DEPUY 1 BONE CEMENT. THIS DEVICE IS INDICATED FOR THE FIXATION OF PROSTHESES TO LIVING BONE IN ORTHOPEDIC MUSCULOSKELETAL SURGICAL PROCEDURES FOR THEUMATOID ARTHRITIS, OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, OSTEOPOROSIS, AVASCULAR NECROSIS, COLLAGEN DISEASE, SEVERE JOINT DESTRUCTION SECONDARY TO TRAUMA OR OTHER CONDITIONS AND REVISION OF PREVIOUS ARTHOROPLASTY.
P960004||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE   ENDOCARDIAL PACING LEADS|NVN|CV|||N|01/29/1996|11/12/1996|97M-0258|07/02/1997|APPR|APPROVAL FOR THE THINLINE(TM) MODELS 430-10 AND 432-04 ENDOCARDIAL PACING LEADS INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR
P960006||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|SWEET TIP(R) RX STEROID ELUTING LEAD|NVN|CV|||N|03/04/1996|10/02/1998|99M-1982||APPR|Approval for the SWEET TIP(R) Rx Models 4143, 4144, 4145, 4243, 4244, and 4245 steroid-eluting, positive-fixation, porous tip, pacing leads.  These devices are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
P960007||SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE|MGR|SU|||N|03/29/1996|03/18/1997|98M-0993|12/07/1998|APPR|APPROVAL FOR THE DERMAGRAFT-TC(TM). THE DEVICE IS INDICATED FOR USE AS A TEMPORARY WOUND COVERING FOR SURGICALLY EXCISED FULL-THICKNESS AND DEEP PARTIAL-THICKNESS THERMAL BURN WOUNDS IN PATIENTS WHO REQUIRE SUCH A COVERING PRIOR TO AUTOGRAFT PLACEMENT
P960009||MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|||Y|05/01/1996|07/31/1997|98M-0905|11/12/1998|APPR|APPROVAL FOR THE MEDTRONIC(R) ACTIVA(TM) TREMOR CONTROL SYSTEM WHICH INCLUDES THE MODEL 3387 DBS(TM) LEAD, MODEL 7495 EXTENSION, MODEL 7424 IMPLANTABLE PULSE GENERATOR (IPG), MODEL 7458 MEMORY MODULE, MODEL 7432 CONSOLE PROGRAMMER, BUR HOLE RING AND CAP, MODEL 7452 MAGNET, MODEL 3625 TEST STIMULATOR (SCREENER) AND MODEL 3353/3354 LEAD FRAME KITS AND ACCESSORIES.  THIS DEVIC IS INDICATED FOR UNILATERAL THALAMIC STIMULATION FOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY IN PATIENTS WHO ARE DIAGNOSED WITH ESSENTIAL TREMOR OR PARKINSONIAN TREMOR NOT ADEQUATELY CONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.
P960010||MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||STENT, CORONARY|MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM|MAF|CV|||N|05/01/1996|06/27/1997|98M-0726|09/09/1998|APWD|APPROVAL FOR THE MEDTRONIC WIKTOR(R) PRIME CORONARY STENT DELIVERY SYSTEM.  THIS DEVICE IS INDICATED FOR THE TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN NATIVE CORONARY ARTERIES AND BYPASS GRAFT VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 3.0 TO 4.5 MM.
P960011||FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID|LZP|OP|||N|05/01/1996|07/16/1998|98M-0604|08/17/1998|APPR|The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery.
P960013||PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS|NVN|CV|||N|05/10/1996|06/20/1997|98M-0450|07/16/1998|APPR|APPROVAL FOR THE TENDRIL(R) DX MODELS 388T/K ENDOCARDIAL, STEROID ELUTING, SCREW-IN PACING LEADS AND VENTRITEX ASSURE(TM) AFS MODELS 7010T/K ENDOCARDIAL, STERIOID ELUTING SCREW-IN PACING LEADS.  THESE DEVICES ARE INDICATED FOR USE IN COMBINATION IWTH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM OR VENTRICLE.
P960014||GLOBAL THERAPEUTICS, INC.|2150 WEST 6TH AVE||BROOMFIELD|CO|80020||Catheters, transluminal coronary angioplasty, percutaneous|MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520|LOX|CV|||N|05/10/1996|10/05/1998|98M-0897|11/18/1998|APWD|Indicated for balloon dilatation of the stenotic portion of a coronary or bypass graft stenosis for the purpose of improving myocardial perfusion.
P960016||St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE(R) CARDIAC ABLATION SYSTEM|LPB|CV|||N|05/17/1996|05/04/1999|99M-1851|06/24/1999|APPR|Approval for the Livewire TC(TM) Cardiac Ablation System.  The device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways assocated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.
N17433||DAVIS & GECK, INC.|ONE CASPER ST.||DANBURY|CT|06810|||PRE OP SPONGE||SU|||N|01/15/1973|10/12/1978|||APPR|
N17796||SANOFI AVENTIS U.S. LLC|55 CORPORATE DRIVE||BRIDGEWATER|NJ|08807|||BRYREL SYRUP||OP|||N|09/19/1975|06/28/1976|||APPR|
N17397||Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|||ACEPTOPLAST CONTACT LENS||OP|||N|05/28/1976|05/28/1976|||APWD|
N17578||AEROJET MEDICAL AND BIOLOGICAL SYSTEMS|9200 EAST FLAIR DR||EL MONTE|CA|91734|||INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC)||MI|||N|05/28/1976|05/28/1976|||APPR|
N17622||AYERST LABORATORIES|685 THIRD AVE||NEW YORK|NY|10017|||FLOURESCEIN SODIUM OPHTHALMIC STRIPS||OP|||N|05/28/1976|05/28/1976|||APPR|
P960018||HEALTHCARE PRODUCTS PLUS, INC.|2119 NORTH KENMORE AVE.||CHICAGO|IL|60614||Device, needle destruction|THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2|MTV|HO|||N|05/28/1996|07/16/1998|98M-0619|08/17/1998|APPR|The device is indicated for use as a mobile sharps needle destruction device that is intended to oxidize non-coated stainless steel needles immediately after use.  The device will oxidize to the hub butterfly-type needles and all needles 16-30 gauge and 4-52mm in length attached to a metal or plastic hub or a vacutainer.  The device is intneded to be used in hospitals and other healthcare facilities.
P960019||LASER VISION CENTERS, INC.|540 MARYVILLE CENTRE DR., #200||ST. LOUIS|MO|63141||Excimer laser system|LASERVISION/VISX EXCIMER LASER MODEL C|LZS|OP|||N|06/03/1996|11/15/1996|97M-0256|07/23/1997|APWD|DEVICE INDICATED FOR: 1)PTK IN PATIENTS W/DECREASED BEST CORRECTED VISUAL ACUITY AND/OR WITH DISABLING PAIN THAT ARE THE RESULT OF SUPERFICIAL CORNEAL EPITHELIAL IRREGULARITIES OR STROMAL SCARS IN THE ANTERIOR ONE-THIRD OF THE CORNEA. THE PATIENTS MUST HAVE FAILED W/ALTERNATIVE TREATMENT OPTIONS. FOR SAFETY, THE IMMEDIATE POSTOPERATIVE CORNEAL THICKNESS MUST NOT BE LESS THAN 250 MICRONS. EXAMPLES OF THOSE CONDITIONS THAT WARRANT PTK ARE: A)CORNEAL SCARS & OPACITY (FROM TRAUMA AND INACTIVE INFECTIONS), B)DYSTROPHIES (REIS-BUCKLER'S, GRANULAR AND LATTICE), C)THYGESON'S SUPERFICIAL KERATITIS, D) IRREGULAR CORNEAL SURFACES ASSOCIATED W/FILAMENTARY KERATITIS AND SALZMANN'S NODULAR DEGENERATION, E)RESIDUAL BAND KERATOPATHY AFTER UNSUCCESSFUL EDTA TREATMENT, AND, F)SCARS SUBSEQUENT TO PREVIOUS (NOT CONCURRENT) PTERYGIUM EXCISION.  2)PRK FOR A 6.0 ABLATION ZONE IN PATIENTS WHO ARE MYOPIC AND MEET ALL OF THE FOLLOWING CRITERIA: 1)1.0 TO 6.0 DIOPTERS (D) OF MYOPIA WITH ASTIGMATISM OF 2.0 DIOPTERS; B)REFRACTIVE CHANGE IS WITHIN 0.5D FOR ONE YEAR PRIOR TO THE LASER TREATMENT; AND C)18 YEARS OF AGE OR OLDER.
P960020||UROMED CORP.|64 A ST.||NEEDHAM|MA|02194||Transurethral occlusion insert, urinary incontinence-control, female|RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE|OCK|GU|||Y|08/18/1995|08/16/1996|96M-0447|12/02/1996|APPR|APPROVAL FOR THE RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
P960022||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS66(TM)|LPM|OP|||N|06/28/1996|12/16/1996|97M-0183|05/22/1997|APPR|APPROVAL FOR THE BAUSCH & LOMB(R) SOFLENS66(TM) (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR.
P960025||DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||Intervertebral fusion device with bone graft, lumbar|BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS|MAX|OR|||Y|07/25/1996|02/02/1999|99M-0894|04/12/1999|APRL|Approval for the Lumbar I/F Cage(R) with VSP(R) Spine System.  The device is indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360 degrees fusion) and posterior pedicle screw fixation.  These pateints may have had a previous non-fusion spinal surgery at the involved spinal level(s).  DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
P960028||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|||N|09/03/1996|09/05/1997|97M-0499|12/09/1997|APPR|Approval for the Model SA4ON AMO(R) Array(R) Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens  (IOL).  This device is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed and who may benefit from useful near vision without reading add and increased spectacle independence across a range of distances where the potential visual effects associated with multifocality are acceptable.  The lens is intended to be placed in the capsular bag.  The lens is available in powers of +16 to +24 diopters.
P960030||PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS|NVN|CV|||N|09/09/1996|01/29/1998|98M-0605|08/12/1998|APPR|Approval for the Passive Plus(R) DX Endocardial, Steroid Eluting, Passive-Fixation Pacing Leads, Models 1342T, 1343K, 1346T, and 1345K.  This device is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1342T or 1343K) or ventricle (Models 1345K or 1346T).
P960031||XYTRONYX, INC.|6730 MESA RIDGE RD. SUITE A||SAN DIEGO|CA|92121|||PERIOGARD PERIODONTAL TISSUE MONITOR||CH|||N|09/19/1996|06/23/1997|98M-0036|01/27/1998|APWD|APPROVAL FOR THE PERIOGARD PERIODONTAL TISSUE MONITOR (PTM).  THIS DEVICE IS INDICATED FOR USE AS A RAPID, CHAIR-SIDE, VISUAL TEST FOR THE QUALITATIVE DETERMINATION OF ASPARTATE AMINOTRANSFERASE (AST) IN GINGIVAL CREVICULAR FLUID.  THE PTM KIT DETECTS ELEVATED LEVELS OF AST ASSOCAITED WITH TISSUE NECROSIS.  IT IS INTENDED TO BE USED AS AN OBJECTIVE, BIOCHEMICAL ADJUNCT TO TRADITIONAL METHODS OF MONITORING PATIENTS TO ASSIST IN THE DECISION TO APPLY TREATMENT AND IN THE EVALUATION OF TREATMENT EFFECTIVENESS.
P960033||STAAR SUGICAL|1911 WALKER AVE.||MONROVIA|CA|91016|||STAARVISC TM SODIUM HYALURONATE||NE|||N|09/23/1996|07/02/1999|99M-4693||APWD|Approval for the STAARVISC(TM) Sodium Hyaluronate Viscoelastic.  This device is indicated for use as a surgical aid in ophthalmic anterior and posterior segment surgery including: 1) Cataract extraction with or without implantation of an intraocular lens; 2) Corneal transplant surgery; 3) Glaucoma filtering surgery; and Secondary lens implantation.  STAARVISC(TM) aids in maintaining a deep anterior chamber during surgery, protecting corneal endothelial and surrounding tissues from touch by instruments or intraocular lenses, inflating the capsular bag after cataract extraction and lubricating surgical instruments.
P960034||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.||NE|||N|10/01/1996|08/12/1998|98M-0725|10/27/1998|APWD|Approval for lens models with the heparin surface modification applied to all your single-piece PMMA lenses approved in P810055.  These models will be specified with a "C" following the number designation for the corresponding non-HSM PMMA model.  The lenses will be marketed under the trade name CeeOn(TM) HSM PMMA IOLs.  This device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by an extracapsular cataract extraction (ECCE) or phacoemulsification.  They are intended to be placed in the capsular bag.
P960036||IOLTECH, S.A.|64 SCHOOSETT STREET||PENBROKE|MA|02359|1882|intraocular lens|MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A)|HQL|OP|||N|10/01/1996|12/22/1997|98M-0137|03/04/1998|APWD|Approval for the MemoryLens(TM) Model U940A ultraviolet-absorbing hydrophilic posterior chamber intraocular lens.  This device is indicated for primary implantation for the visual correction of aphakia in patients sixty years of age or older where a cataractous lens has been removed by an extracapsular cataract extraction method.  The lens is intended for placement in the capsular bag.
P960039||UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, extended wear|SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)|LPM|OP|||N|10/30/1996|04/17/1997|97M-0272|07/08/1997|APWD|APPROVAL FOR THE SOFT-55 EW APHAKIC (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR.  THIS DEVICE IS INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC PERSONS (AFTER CATARACT SURGERY) THAT ARE MYOPIC OR HYPEROPIC.  SOFT-55 EW APHAKIC LENSES MAY BE WORN BY PERSONS WHO MAY EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY
P960040||BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM|LWS|CV|||N|08/20/1996|07/18/1997|98M-0038|01/27/1998|APPR|APPROVAL FOR THE VENTAK(R) AV(TM) AICD(TM) MODEL 1810/MODEL 1815 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD(TM) WITH THE MODEL 2833 SOFTWARE APPLICATION. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA; RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT); PRIOR TO MYOCARDIAL INFARCTION, LEFT VENTRICULAR EJECTION FRACTION OF LESS THAN OR EQUAL TO 35 PERCENT, AND A DOCUMENTED EPISODE OF NONSUSTAINED VT, WITH AN INDUCIBLE VENTRICULAR TACHYARRHYTHMIA.  PATIENTS SUPPRESSIBLE WITH IV PROCAINAMIDE OR AN EQUIVALENT ANTIARRHYTHMIC HAVE NOT BEEN STUDIED.
P960042||SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH|MFA|CV|||Y|11/26/1996|12/09/1997|98M-0451|07/14/1998|APPR|Approval for the 12 French Laser Sheath Kit which consists of the 12 French Laser Sheath (Model 500-001) and Fish Tape accessory.  The device is indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
P960043||ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM|MGB|CV|||Y|11/26/1996|04/30/1997|97M-0274|07/08/1997|APPR|APPROVAL FOR THE PROSTAR(R) PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM.  THE PROSTAR(R) PVS SYSTEM CONSISTS OF THE PROSTAR(R) PVS DEVICE (9 AND 11 FRENCH SIZES) AND THE FOLLOWING ACCESSORIES: A PROSTAR(R) PRE-DILATOR (9 AND 11 FRENCH SIZES), A PERCLOSE(R) KNOT PUSHER, AND PROSTAR(R) TRANSITION GUIDEWIRE, AND A PERCLOSE(R) ARTERIAL TAMPER.  THE PROSTAR(R) PVS SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE ANC REDUCING THE TIME TO HEMOSTASIS AND AMBULATION (TIME-TO-STANDING) OF PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL PROCEDURES USING 8 TO 11 FRENCH SHEATHS
P960044||MILLENIUM MEDICAL SUPPLY, INC.|THE WILLARD OFFICE BLDG.|1455 PENNSYLVANIA AVE., N.W.|WASHINGTON, D.C.   20004|DC|20004||Device, needle destruction|NEEDLE-EASE TM 2501|MTV|HO|||N|12/06/1996|03/06/1997|97M-0186|06/11/1997|APPR|APPROVAL FOR THE NEEDLE-EASE(TM) 2501. THIS DEVICE IS A SHARPS NEEDLE DESTRUCTION DEVICE THAT IS INTENDED FOR HOME USE BY DIABETICS TO REDUCE THE INCIDENCE OF NEEDLESTICKS BY THE INCINERATION OF 28-30 GAUGE NEEDLES, 29 AND 30 GAUGE DIABETIC "PEN TIPS" AND 23-26 GAUGE DIABETIC LANCETS.
P960047||HOWMEDICA OSTEONICS CORP.|59 ROUTE 17 SOUTH||ALLENDALE|NJ|07401|1677|Prosthesis, hip, constrained, cemented or uncemented, metal/polymer|OSTEONICS CONSTRAINED ACETABULAR INSERT|KWZ|OR|||N|12/16/1996|06/13/1997|97M-0459|11/17/1997|APRL|APPROVAL FOR THE OSTEONICS CONSTRAINED ACETABULAR INSERT.  THIS DEVICE IS INDICATED FOR USE AS A COMPONENT OF A TOTAL HIP PROSTHESIS IN PATIENTS AT HIGH RISK OF HIP DISLOCATION DUE TO A HISTORY OF PRIOR DISLOCATION, BONE LOSS, JOINT LAXITY, OR INTRAOPERATIVE INSTABILITY.
P960052||CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)|MPN|SU|||Y|12/24/1996|08/26/1998|98M-0879|10/27/1998|APRL|This device is indicated for topical application to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.  DermaBond(TM) may be used in conjunction with, but not in place of, subcuticular sutures.
P960053||STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, finger, constrained, metal/polymer|BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS|KWG|OR|||N|12/24/1996|06/19/1997|97M-0393|09/23/1997|APPR|APPROVAL FOR THE AVANTA BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS.  THIS DEVICE IS INDICATED FOR TOTAL JOINT REPLACEMENT IN SKELETALLY MATURE PATIENTS WITH PAIN OR INSTABILITY OF THE TRAPEZO-METACARPAL JOINT DUE TO TRAUMA, INFLAMMATORY OR DEGENERATIVE DISEASE OR REVISION OF PREVIOUS PROCEDURES, AS AN ALTERNATIVE TO ARTHRODESIS OR RECONSTRUCTIVE SURGERY.
P960054||DEPUY, A JOHNSON & JOHNSON CO.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, constrained, cemented or uncemented, metal/polymer|S-ROM POLY-DIAL CONSTRAINED LINER|KWZ|OR|||N|12/26/1996|06/19/1997|97M-0416|10/07/1997|APRL|APPROVAL FOR THE JOHNSON AND JOHNSON'S S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER.  THIS DEVICE IS INDICATED FOR USE AS A COMPONENT OF A TOTAL HIP PROSTHESIS IN PRIMARY OR REVISION PATIENTS AT HIGH RISK OF HIP DISLOCATION DUE TO A HISTORY OF PRIOR DISLOCATION, BONE LOSS, JOINT OR SOFT TISSUE LAXITY, NEUROMUSCULAR DISEASE OR INTRAOPERATIVE INSTABILITY.
P960057||WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|||Y|12/23/1996|05/27/1998|98M-0404|06/23/1998|APWD|Approval for ADCON(R)-L Adhesion Barrier Gel.  This device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
P960058||ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION MULTI-STRATEGY COCHLEAR IMPLANT|MCM|EN|||N|12/30/1996|06/26/1997|97M-0396|09/23/1997|APPR|APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT.  THE DEVICE IS INTENDED TO RESTORE A LEVEL OF AUDITORY SENSATION TO CHILDREN WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.  CLARION IS INDICATED FOR THE FOLLOWING: 1)CHILDREN, 2 THROUGH 17 YEARS OF AGE.  IF X-RAYS DEMONSTRATE EVIDENCE OF OSSIFICATION, CHILDREN AS YOUNG AS 18 MONTHS MAY BE IMPLANTED; 2)PROFOUND, BILATERAL SENSORINEURAL DEAFNESS; 3)UNDERGONE OR BE WILLING TO UNDERGO A HEARING AID TRAIL WITH APPROPRIATELY FITTED HEARING AIDS; 4)LACK OF BENEFIT FROM APPROPRIATELY FITTING HEARING AIDS.  IN YOUNGER CHILDREN, LACK OF BENEFIT WITH HEARING AIDS IS DEFINED AS FAILURE TO ATTAIN BASIC AUDITORY MILESTONES SUCH AS A CHILD'S INCONSISTENT RESPONSE TO HIS/HER NAME IN QUIET OR TO ENVIRONMENTAL SOUNDS (MEANINGFUL AUDITORY INTEGRATION SCALE).  IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS SCORING 0% ON OPEN-SET WORD RECOGNITION (PHONETICALLY BALANCED KINDERGARTEN TEST - WORD LIST) ADMINISTERED WITH MONITORED LIVE-VOICE (70 DB SPL).  BOTH YOUNGER AND OLDER CHILDREN SHOULD DEMONSTRATE ONLY MINIMAL ABILITY ON AGE APPROPRIATE OPEN-SET SENTENCE MEASURES AND A PLATEAU IN AUDITORY DEVELOPMENT.
P970002||ALLIANCE MEDICAL TECHNOLOGIES, INC.|17590 GILLETTE AVE.||IRVINE,|CA|92614||HEART-VALVE, MECHANICAL|MONOSTRUT CARDIAC VALVE PROSTHESIS|LWQ|CV|||N|01/24/1997|09/30/1997|98M-0200|04/07/1998|APPR|Approval for the Monostrut(TM) Cardiac Valve Prosthesis.  This device is indicated for the replacement of malfunctioning native or prosthetic mitral (sizes 27, 29, 31, and 33 mm) or aortic (sizes 21, 23, 25, 27, 29, 31, and 33 mm) heart valves.
P970003||Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|||Y|01/27/1997|07/16/1997|98M-0140|03/04/1998|APPR|Approval for the NeuroCybernetic Prosthesis (NCP(R)) System which includes the Model 100 NCP Generator, the Model 300 Series NCP Vagus Nerve Stimulation Lead, the Model 400 Tunneling Tool, and NCP System Accessories.
P970004||MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|||Y|01/30/1997|09/29/1997|98M-0037|01/29/1998|APPR|APPROVAL FOR THE MEDTRONIC(R) INTERSTIM(R) SACRAL NEVE STIMULATION (SNS)(TM) SYSTEM WHICH INCLUDES THE MODEL 3886 OR 3080 LEAD, MODEL 7495 EXTENSION, MODEL 7424 IMPLANTABLE PULSE GENERATOR (IPG), MODEL 7455 MEMORY MODULE, MODEL 7432 CONSOLE PROGRAMMER, MODEL 7452 CONTROL MAGNET, MODEL 3625 TEST STIMULATOR (SCREENER), AND MODEL 3065U PNE KIT AND  ACCESSORIES.  THIS DEVICE IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE IN PATIENT WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
P970005||LASERSIGHT TECHNOLOGIES, INC.|6848 STAPOINT COURT||WINTER PARK|FL|32792||Excimer laser system|KREMER LASER SYSTEM|LZS|OP|||N|01/31/1997|07/30/1998|00M-0811||APPR|Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202.  This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1)with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery.  Note:  Patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0.5D.  Patients 21 years and older should not demonstrate a shift greater than 1.0 D.
P970007||Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK|IL|60064||ENZYME IMMUNOASSAY, TRACROLIMUS|IMX TACROLIMUS II ASSAY|MLM|TX|||Y|02/18/1997|08/26/1997|97M-0520|01/06/1998|APRL|Approval for the IMx(R) Tacrolimus II Assay.  This device is indicated for use as an in-vitro reagent sytemf or the quantitative determination of tacrolimus and some metabolites in human whole blood as an aid in the management of liver allograft patients receiving tacrolimus therapy.
P970008||Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TARGIS (T3) SYSTEM|MEQ|GU|||N|02/24/1997|08/22/1997|97M-0457|11/20/1997|APPR|Approval for the T3(R) Targeted Transurethral Thermoablation System:  Model 4000.  This device is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) and is indicated for men with prostatic lengths of 30 to 50 millimeters.
P970010||SYNTHES (USA)|1690 RUSSELL RD.|POST OFFICE BOX 1766|PAOLI|PA|19301||FILLER, BONE VOID, NON-OSTEOINDUCTION|NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT|MBS|PM|||N|02/24/1997|12/23/1998|99M-4361|10/20/1999|APRL|Indicated for use as an adjunct for fracture stabilization in the treatment of low impact, unstable, metaphyseal distal radius fractures, in cases where early mobilization (cast for 2 weeks, then removable splint for 2-4 weeks) is indicated.  Use of SRS alone in highly comminuted fractures is not indicated.
P970012||MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC.KAPPA 400 SERIES PACEMAKERS|NVZ|CV|||N|02/07/1997|01/30/1998|98M-0231|04/16/1998|APPR|Approval for the Medtronic.Kappa 400 Series Pacemakers, which includes; Medtronic.Kappa KDR 401/403 & KSR 401/403 Implantable Pulse Generators w/Medtronic.Vision (Model 9952E) Software, & Medtronic Model 9462 Remote Assistant.  These devices are indicated for the following:  1)Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent w/increases in activity and/or minute ventilation; 2)Accepted patient conditions warranting chronic cardiac pacing which include: a)symptomatic parosysmal or permanent 2nd  or 3rd degree AV block; b) symptomatic bilateral bundle branch block; c) symptomatic parosysmal or transient sinus node dysfunctions w/ or without associated AV conduction disorders; d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and e) vasovagal syndromes or hypersensitive carotid sinus syndromes. 3) Medtronic.Kappa 400 Series Pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony.  Dual chamber modes are specifcally indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include: a) various degress of AV block to maintain the atrial contribution to cardiac output; and b) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.
P970013||St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|||N|01/03/1997|12/21/2000|01M-0013|01/16/2001|APPR|APPROVAL FOR THE MICRONY(TM) SR+ MODEL 2425T SINGLE CHAMBER RATE ADAPTIVE PULSE GENERATOR, WHICH IS PROGRAMMED WITH THE APS II PROGRAMMER WITH MODLE 3204A SOFTWARE, THE APSU PROGRAMMER, AND THE MODEL 3500/3510 PROGRAMMER WITH MODEL 3304 SOFTWARE.  THE DEIVCE IS INDICATED FOR THE FOLLOWING:  1) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: SICK SINUS SYNDROME; CHRONIC, SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK; RECURRENT ADAMS-STOKES SYNDROME; AND SYMTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHY-ARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  2) ATRIAL PACING IN PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  3) VENTRICULAR PACING IN PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST REQUIRING SHORT PERIODS OF PACING SUPPORT, CHRONIC ATRIAL FIBRILLATION, AND SEVERE PHYSICAL DISABILITY.  4) RATE-MODULATED PACING IN PATIENTS WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.
P970015||SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|INTER FIX THREADED FUSION DEVICE|MAX|OR|||N|03/25/1997|05/14/1999|99M-4277||APRL|Approvalf or the INTER FIX(TM) Threaded Fusion Device.  This device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1.  DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.  These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level.  INTER FIX(TM) implants are indicated to be used with autogenous bone graft and implanted via an open anterior approach.
P970017||HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Bone sonometer|SAHARA CLINICAL BONE SONOMETER|MUA|RA|||N|04/07/1997|03/12/1998|98M-0187|04/16/1998|APRL|Approval for the Sahara Clinical Bone Sonometer.  The intended use of the Sahara Clinical Bone Sonometer is to:  Perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clincal risk factors as an aid to the physician in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the determination of fracture risk.  Sahara measures the speed of sound (SOS, in m/s) and broadband ultrasonic attenuation (BUA, in dB/MHz) of an ultrasound beam passed throught he calcaneus, and combines these results linearly to obtain the Quantitative Ultrasound Index (QUI).  The output is also expressed as a T-score and as an estimate of the Bone Mineral Density (BMD, in g/cm2) of the calcaneus as measured by Dual Energy X-ray Absorpiometry (DXA).
P970018||BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|||N|05/12/1997|06/17/1999|99M-2144|07/07/1999|APPR|This device is indicated as a liquid-based, thin-layer cell preparation process.  The system produces slides that are intended as replacements for conventional gynecologic Pap smears.  AutoCyte PREP slides are intended for use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.
P970019||HEALTH TRONICS SURGICAL SERVICES, INC.|425 FRANKLIN RD., SUITE 545||MARIETTA|GA|30067||Lithotriptor, extracorporeal shock-wave,urological|HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM|LNS|GU|||N|05/16/1997|07/21/1997|97M-0453|11/14/1997|APRL|APPROVAL FOR THE LITHOTRON(TM) LITHOTRIPSY SYSTEM.  THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH RENAL AND UPPER URETERAL CALCULI BETWEEN 4 AND 20 MM IN SIZE.
P970020||ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS|MAF|CV|||N|06/12/1997|10/02/1997|98M-0971||APPR|Approval for the ACS Multi-Link(TM) Coronary Stent System containing ACS Multi-Link(TM) CSS, ACS RX Multi-Link(TM) Coronary Stent System containing ACS Multi-Link(TM) CSS, ACS RX Multi-Link HP(TM) CSS, ACS OTW Multi-Link HP(TM) CSS, and ACS RX Multi-Link(TM) CSS delivery platforms.  The device with ACS Multi-Link(TM) CSS, ACS RX Multi-Link HP(TM) CSS and ACS OTW Multi-Link HP(TM) CSS delivery platforms is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic native coronary artery lesions (length <20 mm) with a reference vessel diameter ranging from 3.0 mm to 3.75 mm and is intended to improve coronary luminal diameter.  The device with ACS RX Multi-Link(TM) CSS delivery platform, however, is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic native coronary artery lesions (length <22mm) with a reference vessel diameter ranging from 3.0 mm to 3.5 mm and is intended to improve coronary luminal diameter.
P970021||GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM|MNB|OB|||N|06/17/1997|12/12/1997|98M-0139|03/04/1998|APWD|Approval for the ThermaChoice(TM) Uterine Balloon Therapy(TM) UBT System.  This device is indicated for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete.
P970024||SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable cardioverter defibrillator (non-CRT)|ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM.|LWS|CV|||N|06/19/1997|08/19/1998|99M-1981||APPR|The device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations:  1) Survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; and 2) Recurrnet, poolrly tolerated, sustained ventricular tachyarrhythmia.
P970025||DIASORIN, INC.|1990 INDUSTRIAL BLVD.|P.O. BOX 285|STILLWATER|MN|55082||ENZYME IMMUNOASSAY, TRACROLIMUS|PRO-TRAC II TACROLIMUS ELISA KIT|MLM|TX|||N|06/30/1997|04/27/1999|01M-0072|02/16/2001|APRL|Approval for PRO-Trac(TM) II Tacrolimus ELISA Kit.  This device is indicated for the quantitative determination of tacrolimus ELISA Kit.  This device indicated for the quantitative determination of tacrolimus (Prograf(R) FK506) and some metabolites in EDTA or heparinized human whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
P970026||MYRIAD ULTRASOUND SYSTEMS LTD.|P.O. BOX 601|WEIZMANN SCIENCE PARK|REHOVOT||76106||Bone sonometer|MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN|MUA|RA|||N|07/01/1997|05/29/1998|98M-0722|09/09/1998|APRL|Perform quantitative ultrasound measurement of tibia (shin bone), the results of which can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and medical conditions leading to reduced bone strength and ultimately, in the determination of fracture risk.  The SoundScan measures the velocity ofultrasound (speed of sound, SOS, in m/sec) along the tibia, exclusivey within bone, unaffected by overyling soft tissue.  SOS along the tibia provides an index of bone strength, with stronger bone having higher velocities.  As such the SoundScan provides a measure of skeletal fragility.  The SoundScan reports SOS along with both T- and Z-scores.
P970027||Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT AXSYM ANTIBODY TO HCV|MZO|MI|||N|07/01/1997|02/05/2004|04M-0207|05/05/2004|APWD|APPROVAL FOR THE ABBOTT AXSYM ANTIBODY TO HCV.  THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF ANTI-HCV RECOMBINANT PROTEINS IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, SODIUM EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, SODIUM CITRATE, AND POTASSIUM OXALATE).
P970029||CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|TMR HOLMIUM LASER SYSTEM|MNO|CV|||Y|07/02/1997|02/11/1999|99M-2238|07/19/1999|APPR|Approval for the Eclipse TMR Holmium Laser System.  Transmyocardial revascularization with the Eclipse TMR System is indicated for treatment of stable patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium iwth reversible ischemia not amendable to direct coronary revascularization.
P970030||St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TORONTO SPV VALVE|LWR|CV|||N|07/07/1997|11/04/1997|98M-0836||APWD|Approval for the Toronto SPV(R) Valve, Model SPA-101, sizes 21, 23, 25, 27, and 29 mm and the Toronto SPV(R) Valve Sizer Set, Model 300SPA.  The device is a tissue heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves.
P970031||MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|||N|07/14/1997|11/26/1997|98M-0906||APPR|Approval for the Medtronic FREESTYLE(R) Aortic Root Bioprosthesis, Model 995; sizes 19, 21, 23, 25, 27 mm; implantation techniqures, subcoronary, full-root, and root inclusion; and the FREESTYLE(R) Aortic Obturators, Model 7990 and the Medtronic Handle, Model 0791. This device is a replacement heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves with the optio of aortic root replacement.
P970032||HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||salivary estriol test|SALEST TM SYSTEM|PEJ|CH|||Y|07/16/1997|04/29/1998|99M-2168|07/13/1999|APWD|Approval for the SalEst(TM).  This device is intended to detect and measure by enzyme-linked immunoabsorbant assay (ELISA) technology the level of salivary estriol in pregnant women.  The device is indicated for use as an aid in identifying risk of spontaneous preterm labor and delivery in singleton pregnancies.  The device can be used every 1 to 2 weeks from gestational ages 22 to 36 weeks.  The test should be used as a component of the clinician's assessment of risk for preterm labor and delivery.
P970033||MIRABEL MEDICAL SYSTEMS, INC.|9020-1 CAPITAL OF TEXAS HGWY|SUITE 390|AUSTIN|TX|78759||Imager, breast, electrical impedance|T-SCAN 2000|NCL|RA|||N|07/16/1997|04/16/1999|99M-1073||APPR|Approval for the TransScan T-Scan 2000.  The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic finding within ACR BI-RADS (TM) categories 3 or 4.  In particular, it is nnot intended for use in cases with clear mammographic or non-mammographic indications for biopsy.  This device provides the radiologist with additional information to guide a biopsy recommendation.
P970034||AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|07/21/1997|09/25/1998|98M-0855|10/27/1998|APWD|Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation.  The intraocular lens is intended to permanently replace the natural cataractous crystalline lens and to restore useful vision.  It is intended for capsular bag placement only.  The devices are available in a range of powers from 4 diopters (D) to 34D in 0.5D increments.
P970035||MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|||N|08/05/1997|12/23/1997|98M-0973||APWD|Approval for the AVE Micro Stent(TM) II Over-the-Wire Coronary Stent System and the AVE GFX(TM) Over-the-Wire Coronary Stent System.  The devices are indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length < 30 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm.  Stenting is intended to improve coronary luminal diameter (see Individualization of Treatment).  Long term outcome (beyond 6 months) for this permanent implant is unknown at present.
P970036||NIC LTD.|320 FAIRWAY DR.||HALF MOON BAY|CA|94019||Device, needle destruction|NIC 1800 NEEDLE DISPOSAL SYSTEM|MTV|HO|||N|08/08/1997|09/26/1997|98M-0039|01/30/1998|APPR|Approval for the NiC1800 Needle Disposal System.  This device is indicated for the disposal of standard plastic syringe mounted hypodermic needles (19 gauge through 28 gauge, up to 2 inces in length) in patient treatment and clinical laboratory settings.
P970037||PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA HAFP TEST KIT|LOK|IM|||N|08/26/1997|03/31/1998|98M-0306|05/27/1998|APPR|The device is intended for the quantitative determination of human alpha-fetoprotein (AFP) in maternal serum and amniotic fluid obtained between the 15th and 21st weeks of gestation.  The assay is to be peformed on the 1235 AutoDELFIA(TM) automatic immunoassay system, and is intended for use only in conjunction with other diagnostic tools such as ultrasound and amniography as an aid in the detection of Open Neural Tube Defects (ONTDs).
P970038||BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY|MTG|IM|||N|08/29/1997|03/10/1998|98M-0201|04/16/1998|APPR|Approval for the Tandem(R)-R free PSA assay and Tandem(R)-MP free PSA assay.  The Tandem(R)-R free PSA Immunoradiometric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum.  The Tandem(R)-MP free PSA Immunoenzymetric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum.  Hybritech's Tandem free PSA assays are intened to beused with Tandem (total) PSa to calculate the ration of fee PSA to total PSA expressed as a percentage (percent free PSA).  Percent free PSA as measured by Hybritech's Tandem assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic condtions, when used in conjuction with Tandem (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/ml and digital rectal examination finding that are not suspicious for cancer.  Prostatic biopsy is required for diagnosis of cancer.
P970040||GE LUNAR CORP.|726 HEARTLAND TRAIL||MADISON|WI|53717||Bone sonometer|ACHILLES EXPRESS ULTRASONOMETER|MUA|RA|||N|09/02/1997|06/26/1998|98M-0715|10/07/1998|APRL|The device is indicated as follows:  The Achilles+ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.  The Stiffnes Index indicateds risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at teh spine or hip.  Stiffness Index results expressed as T-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are T-scores or obtained by X-ray absorpiometry.  either the Stiffness Index T-score or X-ray absorptiometry T-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.  The Stiffness Index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for moniotirng bone changes.
P970042||MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotripter, shockwave (for treating gallbladder stones)|MEDSTONE STS LITHOTRIPTER|NCV|GU|||N|09/04/1997|09/05/2000|00M-1515|09/15/2000|APWD|APPROVAL FOR THE MEDSTONE STS(TM) LITHOTRIPTER IN CONJUNCTION WITH ACTGALL(R).  WHEN USED WITH THE DRUG, THIS DEVICE IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (BETWEEN 4 AND 20 MM IN MAXIMUM DIAMETER) IN ADULT PATIENTS FOR WHOM SURGICAL REMOVAL OF THE GALLBLADDER IS MEDICALLY CONTRAINDICATED AND IN SYMPTOMATIC HIGH-RISK PATIENTS WHO HAVE ACTIVELY REFUSED SURGERY.  COMBINATION THERAPY CONSISTS OF 1) ADMINISTRATION OF ACTIGALL(R) (8-10 MG/KG/DAY) FOR AT LEAST TWO WEEKS PRE-LITHOTRIPSY, 2) LITHOTRIPSY TREATMENTS OF UP TO 2000 24 KV SHOCKS, AND 3) CONTINUED ADMINISTRATION OF ACTIGALL(R) UNTIL A STONE-FREE STATE IS ACHIEVED.
P970043||ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION EXCIMER LASER SYSTEM|LZS|OP|||N|09/05/1997|11/02/1998|00M-1592|02/05/2001|APWD|Indicated for use in photorefractive keratectomy (PRK) treatment for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics: 1) between -1.00D to -10.00D of sphere and less than or equal to -4.00D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50D and -10.00D spherical equivalent (SE) at the spectacle plane where sphere or cylinder is at least 1.00D; 2) who are 21 years of age or older; and 3) with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.50D for corrections up to -7.00D SE, and less than or equal to -1.00D for corrections greater than -7.00 D SE.
P970044||Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM|MEQ|GU|||N|09/08/1997|05/29/1998|98M-0403|06/23/1998|APWD|This device is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with prostatic lengths between 30 mm and 55 mm.
P970049||DTC EYE SURGERY CENTER|8400 EAST PRENTICE AVE.|SUITE 1200|ENGLEWOOD|CO|80111|||DISHLER EXCIMER LASER SYSTEMS||NE|||N|10/06/1997|12/16/1999|01M-0043|02/05/2001|APWD|Approval for LASIK in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from -0.5 to -13.0 diopters (D) MRSE (manifest refraction spherical equivalence) with or without -0.5 D to - 4.0 D astigmatism; and in patients with documented evidence of changes refraction of less than or equal to 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of preoperative examination.
P970051||Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|||N|11/03/1997|06/25/1998|98M-0711|09/09/1998|APPR|INTENDED TO RESTORE A LEVEL OF AUDITORY SENSATIONTO ADULTS AND CHILDREN VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.
P970052||ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||Catheters, transluminal coronary angioplasty, percutaneous|FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS|LOX|CV|||N|11/04/1997|02/20/1998|98M-0162|03/20/1998|APWD|Approval for the FACT(TM), ARC(TM), LYNX(TM) and Guardian(TM) Balloon Coronary Dilatation Catheters.  These devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purposed of improving myocardial perfusion.  The application includes authorization from Endosoncis Corp., Rancho Cordova, CA, to incorporate information contained in its approved premarket approval application and related supplements for hte Cathscanner(R) Oracle(R) Micro PTCA Catheter.
P970053||NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|EC-5000 EXCIMER LASER SYSTEM|LZS|OP|||N|11/06/1997|12/17/1998|00M-1640|12/08/2000|APPR|Approval for the Nidek EC-5000 Excimer Laser System.  This device is indicated for photorefractive keratectomy (PRK) for the reduction or elimination of mild to moderate myopia in patients with the following three characterisitics: 1) In PRK treatments for the reduction or elimination of myopia in the low, moderate, or high ranges (-0.75 Diopters (D) to -13.00D) spherical equivalent (S.E.) at the spectacle plan, uncomplicated by refractive astigmatism (i.e., <0.75D in any meridian). 2) In patients who have a stable history of pretreatment myopia, that is a change of < 0.50D in sphere or cylinder in the 12 months period preceding treatment for correction of myopia <-7.0D S.E., or a change of <1.00D in sphere or cylinder for correction of myopia >-7.0D S.E. 3) In patients who are over 21 years of age.
P970054||DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|BIOTRIN PARVOVIRUS B19 IGG|MYL|MI|||N|08/28/1997|08/06/1999|00M-1216||APPR|This device is indicated for:  The Biotrin Parvovirus B19 IgG Enzyme Immunoassay is intended for the qualitative detection of IgG antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human serum, lithium heparin, EDTA, and citrated plasma.  This test, in conjunction w/the Biotrin Parvovirus B19 IgM Enzyme Immunoassay, may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure with B19V. The results of these assays may be used tomake a serological determination of past, recent, or current infection with B19V.  The clinician should consider the results of these assays as presumptive for risk of fetal infection with B19V.  The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum).
P970055||DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)|MYM|MI|||N|08/28/1997|08/06/1999|00M-1215||APPR|The device is intended for the qualitative detection if IgM antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human seru, lithium heparin, EDTA, and citrated plasma.  This test, in conjunction with the Biotrin Parvovirus B19 IgG Enzyme Immunoassay, may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure with B19V.  The results of these assays may be used to make a serological determination of past, recent, or current infection with B19V.  The clinician should consider the results of these assays as presumptive for risk of fetal infection with B19V.  The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum).
P970056||TECHNOLAS GMBH PERFECT VISION|PO BOX 17190||ANAHEIM HILLS|CA|92817||Excimer laser system|BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM|LZS|OP|||N|11/13/1997|09/28/1999|01M-0309|07/23/2001|APWD|Approval for 16 units of the KERACOR(R) 116 ophthalmic excimer laser system.  This device is indicated for myopic photorefractive keratectomy (PRK) in patients who meet the following criteria:  1) In Photorefractive Keratectomy (PRK) treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism. 2) In patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder an sphere components) for at least one year prior to the date of the pre-operative examination. 3) In patients who are 18 yrs of age or older.
P970058||HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|M1000 IMAGECHECKER|MYN|RA|||N|12/16/1997|06/26/1998|98M-0618|08/12/1998|APPR|The Image Checker M1000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them tot he attention of the radiologist after the initial readin ghas been completed.  Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.
P970061||BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM|MAF|CV|||N|12/22/1997|07/16/1998|99M-1980|06/28/1999|APWD|The device is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length <30 mm) with a reference vessel diameter ranging from 2.75 mm to 4.25 mm and is intended to improve coronary luminal diameter.  Long-term outcome (beyond 6 months) for this permanent implatn is unknown.
P970062||BMT, INC.|660 MAIN ST. SOUTH|SUITE 7|WOODBURY|CT|06798||Lithotriptor, extracorporeal shock-wave,urological|GENESTONE 190 LITHOTRIPTER|LNS|GU|||N|12/23/1997|06/24/1998|98M-0507|10/07/1998|APRL|Approval for the Genestone 190 Lithotripter.  This device is indicated for use in the non-invasive fragmentation of kidney (renal pelvic and renal calyceal) and upper ureteral stones between 5 and 20mm in size.
P980001||Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760||STENT, CORONARY|NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM|MAF|CV|||N|01/28/1998|08/11/1998|99M-1696|06/09/1999|APWD|approval for the NIR ON(TM) Ranger(TM) and NIR ON(TM) Ranger(TM) w/SOX(TM) Premounted Stent Systems.  The device is indicated for improving coronary luminal diamter in the following patient subsets:  a)patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length <25 mm) with a reference vessel diameter of 3.0 to 4.0 mm; b) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2.5 to 4.0 mm; c) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesion length < 30 mm and reference vessel diamter in the range of 3.0 to 4.0mm.
P980003||Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED RF ABLATION SYSTEM|LPB|CV|||Y|01/30/1998|02/02/1999|99M-2016|06/28/1999|APPR|Approval for the Chili(R) Cooled Ablation System which includes: 1)Chili(R) Cooled Ablation Catheter, Standard Curve (Model 3005; 2)Chili(R) Cooled Ablation Catheter, Large Curve (Model 3006); RF Generator/Pump System (Model 8004); EGM Bypass Switch Box (model 2035); RF Filter Box (Model 2048); Chili(R) Tubing Kit (Model 2100); EGM/RF Generator Cable (Models 2001 and 2028); and EGM Generator Cable (Model 2002 and 2029). This device is indicated for cardiac electropysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.
P980006||Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR|LPM|OP|||N|03/06/1998|02/05/1999|99M-0237||APPR|Approval for the PureVision(TM) (balafilcon A) Visibility Tinted Contact Lens.  This device is indicated for daily or extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner.  The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity.
P980007||Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|AXSYM FREE PSA|MTG|IM|||N|03/09/1998|02/05/2004|04M-0253|06/05/2004|APPR|APPROVAL FOR THE AXSYM FREE PSA ASSAY.  THE DEVICE IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM.  THE AXSYM FREE PSA ASSAY IS INTENDED TO BE USED IN PSA VALUES BETWEEN 4 AND 10 NG/ML AND NON-SUSPICIOUS DRE TO DETERMINE THE % FREE PSA VALUE.  THE AXSYM% FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE.
P980008||LASERSIGHT TECHNOLOGIES, INC.|6903 UNIVERSITY BLVD.,||WINTER PARK|FL|32792||Excimer laser system|LASERSCAN LSX EXCIMER LASER SYSTEM|LZS|OP|||N|03/19/1998|11/12/1999|00M-1231||APPR|Approval for the LaserScan LSX Excimer Laser System.  The device is indicated for myopic photorefractive keratectomy: for the reduction or elimination of myopia ranging from -1.0 to less than -6.0 diopters (D) with less than or equal to 1.0 D of astigmatism; in patients with documentation of a stable manifest refraction (+-0.5D) over the prior one year; and in patients who are 18 years of age or older.
P980009||BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT ENDOPROTHESIS|MAF|CV|||N|04/01/1998|09/29/1998|99M-2028|06/24/1999|APWD|Approval for the Magic WALLSTENT(R) Endoprosthesis.  This device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discreter de novo lesions in native coronary arteries (length <35mm) with a reference vessel diameter of 3.0 to 5.5mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 3.0 to 5.5mm.
P980010||OSTEOMETER MEDITECH A/S|1, KOGLE ALLE||HORSHOLM||DK-29|2970|Bone sonometer|DTU-ONE ULTRASOUND SCANNER|MUA|RA|||N|04/15/1998|09/19/2000|00M-1615|11/15/2000|APRL|APPROVAL FOR THE DTU-ONE ULTRASOUND SCANNER.  THE DTU-ONE IS INTENDED TO PERFORM QUANTITATIVE ULTRASOUND MEASUREMENT OF THE CALCANEUS (THE HEEL BONE), THE RESULTS OF WHICH CAN BE USED IN CONJUNCTION WITH OTHER CLINICAL RISK FACTORS AS AN AID TO THE PHYSICIAN IN DIAGNOSIS OF OSTEOPOROSIS (T-SCORE) AND IN THE DETERMINATION OF FRACTURE RISK IN MEN AND WOMEN.  THE MEASUREMENT MAY ALSO BE USED IN CAUCASIAN WOMEN TO AID IN THE DETECTION OF MEDICAL CONDITIONS, OTHER THAN AGE-RELATED BONE LOSS, THAT LEAD TO REDUCED BONE DENSITY.
P980012||WORLD HEART, INC.|7799 PARDEE LN.||OAKLAND|CA|94621||Ventricular (assisst) bypass|NOVACOR LVAS|DSQ|CV|||N|04/24/1998|09/29/1998|99M-2605||APWD|Approval for the Novacor(R) LVAS.  This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure.  The LVAS is indicated for use both inside and outside the hospital.
P980015||INNOVATIVE MEDICAL SYSTEMS, INC.|3610 OAKDALE DRIVE||MOUNTAIN BROOK|AL|35223||Device, needle destruction|SHARPX|MTV|HO|||N|05/08/1998|08/06/1998|98M-0679|09/17/1998|APPR|Approval for the Sharpx(TM) Needle Destruction Unit.  The device is indicated for the destruction of 19 to 27 gauge hypodermic needles up to two inches in length.  The unit is for use by healthcare professionals in out-patient and in-patient treatment settings and clinical laboratoreis.
P980016||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|||N|05/11/1998|10/09/1998|98M-0907|12/07/1998|APPR|Approval for the Medtronic(R) Model 7271 GEM(TM) DR Dual Chamber Implantable Cardioverter Defibrillator System with Mdoel 9960 (GEM(TM) DR) Application Software, Medtronic(R) Model 6940 CapSureFix(R) Lead and Model 9466 Patient Magnet.  This system is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations:  survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to ventricular tachyarrhythmia or recurrent, poorly tolerated, sustained ventricular tachycardia. (Note: the clinical outcome for hemodynamically stable VT patients is not fully known.  Safety and effectiveness studies have not been conducted.)
P980017||POSSIS MEDICAL, INC.|9055 EVERGREEN BLVD., N.W.||MINNEAPOLIS|MN|55433|8003||PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20||CV|||Y|12/12/1997|09/25/1998|98M-0835||APWD|Approval for the Possis Perma-Seal(R) Dialysis Access Graft, Model 2C20-B.  This device is indicated for use as a subcutaneous arteriovenous shunt graft to provide immediate and subsequent chronic blood access for high-efficiency hemodialysis in patients who meet one or more of the following conditons: 1) central venous cannulation is deemed hazardous or is technically unavailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.
P980018||DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|DAKO HERCEPTEST|MVC|PA|||N|05/18/1998|09/25/1998|98M-0857|10/27/1998|APPR|Approval for the DAKO Herceptest.  This device is a semi-quantitative immunohistochemical assay to determine HER2 overexpression in breast cancer tissues routinely processed for histological evaluation.  HercepTest is indicated as an aid in the assessment of patients for whom HERCEPTIN(R)(Transtuzumab) treatment is being considered.
P980020||QCARE INTERNATIONAL, LLC.|680 ATLANTA COUNTRY CLUB DR.||MARIETTA|GA|30067||Device, needle destruction|Q 103 NEEDLE MANAGEMENT SYSTEM|MTV|HO|||N|05/26/1998|12/21/2000|00M-1684|01/03/2001|APPR|APPROVAL FOR THE QCARE NEEDLE MANAGEMENT SYSTEM.  THIS DEVICE IS A NEEDLE DESTRUCTION DEVICE INTENDED TO BE USED IN A HOME CARE ENVIRONMENT TO SEVER 1/2 INCH HYPODERMIC NEEDLES (GAUGES 28-29) FROM INSULIN SYRINGES AND STORE THEM FOR DISPOSAL.
P980022||MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|||Y|12/15/1997|06/15/1999|99M-2169|07/14/1999|APPR|The device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus.  This information is intended to supplement, not replace blood glucose information obtained using standard home glucose monitoring devices.  The information collected by the device may be downloaded and displayed on a computer and review by healthcare professionals.  This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments, which may minimize these excursions.
P980023||BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|LWS|CV|||N|06/08/1998|10/27/1998|98M-0972|11/18/1998|APPR|Approval for the Phylax Implantable Cardioverter Defibrillator (ICD) System: a) ICD PUlse Generator - Phylax XM ICD, model number 121491; Phylax XM Active Housing ICD, model number 121492; Phylax XM Replacement ICD, model number 121162 and mycroPhylax ICD, model number 121493; b) ICD Lead - SPS 75 Lead System, model number 120398; SL-ICD Lead Systems (SL-ICD 75/13, model number 120395, SL-ICD 75/16, model number 120396, SL-ICD 75/18, model number 120397, SL-ICD 100/13, model number 116414, SL-ICD 100/16, model number 118375, SL-ICD118375, SL-ICD 100/18, model number 119077); Kainox SL Lead Systems (Kainox SL 75/13, model number 124219, Kainox SL 75/16, model number 124218, Kainox SL 75/18, model number 124217, Kainox SL 100/13, model number 124238, Kainox SL 100/16, model number 124239, Kainox SL 100/18, model number 124240); Kainox RV 75 Lead System, model number 124005; and (c) Programming and Monitoring System - TMS 1000 Tachyarrhythmia Monitoring System, and Software Module SWM 1000 F00I01.  This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmia; or recurrent poorly tolerated sustained ventricular tachycardia (VT). Note: the clinical outcome for hemodynamically stable VT patients is not fully know.  Safety and effectiveness studies for this indication have not been conducted.
P980024||ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|||N|06/16/1998|12/11/1998|99M-0034|01/20/1999|APPR|Approval for the PathyVysion(TM) HER-2 DNA Probe Kit.  The PathyVysion(TM) HER-2 DNA Probe Kit (PathyVysion Kit) is designed to detect amplification ofthe HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded human breast cancer tissue speciments.  Results from the PathVysion Kit are intended for use as an adjuncto to existing clinical and pathologic information currently used as prognostic factors in state II, node-positive breast cancer patients.  The PathVysion Kit is further indicated as an aid in predct disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, dosorubicin, and 5-fluorouracil (CAF) chemotherapy.
P980025||CARESTREAM DENTAL LLC|1765 THE EXCHANGE||ATLANTA|GA|30339||Analyzer,medical image|LOGICON CARIES DETECTOR|MYN|RA|||N|06/18/1998|09/25/1998|98M-0856|10/27/1998|APPR|The Logicon Caries Detector(TM) is a sotware decison aid for the diagnosis of caries that have penetrated into the dentin, on unrestored proximal surfaces of secondary dentition, through the analysis of digital intra-oral radiographic imagery.  It is intended as an adjunct designed to work in conjunction with existing Trextrophy RVG digital x-ray radiographic system with TWI Software Version 3.0 or higher.
P980031||ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS|LQE|OP|||N|07/14/1998|04/09/1999|99M-1167||APPR|This device is indicated for the reduction or elimination of mild myopia (-2.00 to -3.00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0.50D for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1.00D or less.
P980033||BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDOPROSTHESIS|MAF|CV|||N|08/03/1998|11/16/2001|02M-0203|05/09/2002|APPR|APPROVAL FOR THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS RP DELIVERY SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS (12 MM - 16 MM VENOUS ENDOPROSTHESES).  THESE DEVICES ARE INDICATED FOR IMPROVING CENTRAL VENOUS LUMINAL DIAMETER FOLLOWING UNSECCESSFUL ANGIOPLASTY IN PATIENTS ON CHRONIC HEMODIALYSIS WITH STENOSIS OF THE VENOUS OUTFLOW TRACT.  UNSUCCESSFUL ANGIOPLASTY IS DEFINED AS RESIDUAL STENOSIS >= 30 PERCENT FOR A VEIN <= 10 MM IN DIAMETER OR >= 50 PERCENT FOR A VEIN > 10 MM IN DIAMETER, A TEAR WHICH INTERRUPTS THE INTEGRITY OF THE INTIMA OR LUMEN, ABRUPT LESION SITE OCCLUSION, OR REFRACTORY SPASM.  THE VESSELS THAT CAN BE TREATED WITH THE DEVICE ARE THE INNOMINATE AND SUBCLAVIAN VEINS RANGING FROM 8 MM TO 15 MM IN DIAMETER.
P980035||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE|NVZ|CV|||N|08/25/1998|01/29/1999|99M-2671|08/17/1999|APPR|Approval for the Medtronic.Kappa(TM) 700/600 Series Pacemakers, which include; Medtronic.Kappa(TM) Kdr 701, 703, 706, 721, 731, 733, 601, 603, and 606; Kd 701, 703, and 706; Kvdd 701; and Ksr 701, 703, and 706 implantable pacemakers with Medtronic.Vision (Model 9953E) Software.  These devices are indicated for the following: Rate adaptive pacing in patients who may benefit from increase pacing rates concurrent with increases in activity; Accepted patient conditions warranting chronic cardiac pacing which include: - Symptomatic parosysmal or permanents second or third-degree AV block; - Symptomatic bilateral bundle branch block; - Symptomatic paroxysmal or transient sinus node dysfunctions with or without assocated AV conduction disorders; - Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; - Vasovagal syndromes or hypersensitive carotid sinus syndromes.  In addition, Medtronic.Kappa(TM) 700/600 Series pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include: -various degrees of AV block to maintain the atrial contribution to cardiac output; -VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. Medtronic.Kappa(TM) 700/600 Series pacemakers are also indicated for VDD modes in patients having adequate atrial rates and the following indications: - Requirements for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present.  This includes the presence of complete AV block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome has existed or is anticipated.  Normal sinus rhythm and normal AV conduction in patients needing ventricular pacing intermittently.
P980037||Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER|MCX|CV|||Y|09/14/1998|03/12/1999|99M-2015|06/28/1999|APPR|Approval for the AngioJet(R) Rheolytic(TM) Thrombectomy system (AngioJet(R) Drive Unite, AngioJet(R) Pump Set, and AngioJet(R) Rheolytic(TM) Thrombectomy LF140 Catheter).  This device is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesion in vessels > 2.0mm in diameter prior to balloon angioplasty or stent placement.
P980040||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|||N|10/01/1998|02/03/2000|00M=0445|02/16/2000|APPR|Approval for the AMO® SENSAR™ Soft Acrylic, UV Light-Absorbing, Posterior Chamber Intraocular Lens (IOL), Model AR40.  This device is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by extracapsular cataract extraction.  The lens is intended to be placed in the capsular bag.
P980041||BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP IMMUNOASSAY SYSTEM|LOK|IM|||N|10/16/1998|02/08/1999|99M-0793|04/08/1999|APPR|Approval for the Access(R) AFP Reagents on the Access(R) Immunoassay Analyzer.  The Access(R) AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access(R) Immunoassay System for the quantitative determination fo alpha-fetoprotein (AFP) in: 1)Human seru, as an aid in management of patients with non-seminomatous testicular cancer. 2) Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD).  The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
P980043||MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|||N|10/29/1998|09/28/1999|99M-4279|10/15/1999|APPR|Approval for the Medtronic Hancock(R) II Bioprosthetic Heart Valve, Models T505 (odd sizes 21 through 29 mm) and T510 (odd sizes 25 through 33 mm).  This device is indicated for the replacement of pathologic or prosthetic aortic and mitral valves.
P980044||SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX|MOZ|OR|||N|12/01/1998|01/24/2001|01M-0342|08/13/2001|APPR|APPROVAL FOR THE SUPARTZ(TM) DISPO.  THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P980046||HOME ACCESS HEALTH CORP.|2401 W. HASSELL|SUITE 1510|HOFFMAN ESTATES|IL|60195|5200|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS|MZO|MI|||Y|12/07/1998|04/28/1999|99M-2143|07/13/1999|APPR|Approval for the Home Access(R) Hepatitis C Check(SM) and Hepatitis C Check(SM) Express.  This device is indicated for home use for collection of a dried blood spot speciment by finger-stick, and is indicated for anonymous testing for antibody to hepatitis C virus (HCV) in adults, eighteen years or older, who may have been exposed to HCV through transfusion or organ transplant before 1992, who may have injected non-prescription durgs, or who were exposed to infected needles or had sexual contacts with HCV infected individuals.
P980048||SULZER SPINE-TECH|7375 BUSH LAKE RD.||MINNEAPOLIS|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM|MAX|OR|||Y|12/15/1998|04/20/2001|03M-0122|03/31/2003|APRL|APPROVAL FOR THE BAK/CERVICAL (BAK/C(R)) INTERBODY FUSION SYSTEM.  THE DEVICE IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) OF THE CERVICAL SPINE WITH ACCOMPANYING RADICULAR SYMPTOMS AT ONE DISC LEVEL.  DDD IS DEFINED AS DISCOGENIC PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.  BAK/C IMPLANTS ARE USED TO FACILITATE FUSION IN THE CERVICAL SPINE AND ARE PLACED VIA AN ANTERIOR APPROACH AT THE C-3 TO C-7 DISC LEVELS USING AUTOGRAFT BONE.
P980049||SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|MRM|CV|||N|12/18/1998|09/15/1999|00M-0915||APPR|This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have expierienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 2) recurrent poorly tolerated, sustained ventricular tachycardia (VT).
P980050||MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF|LWS|CV|||N|12/24/1998|06/14/2000|00M-1389|07/12/2000|APPR|APPROVAL FOR THE MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), MODEL 9961 PROGRAMMER APPLICATION SOFTWARE, AND MEDTRONIC(R) SPRINT(TM) MODEL 6943 STEROID ELUTING, SCREW-IN, ATRIAL/VENTRICULAR LEAD.  THIS SYSTEM IS INDICATED FOR USE IN ICD PATIENTS EITHER WITH ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  PATIENTS INDICATED FOR AN ICD ARE THOSE PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR...
P980052||TMJ CONCEPTS|2233 KNOLL DRIVE||VENTURA|CA|93003||Joint, temporomandibular, implant|TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS|LZD|DE|||N|01/06/1999|07/02/1999|99M-2551|08/02/1999|APPR|Approval for the TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis.  The device is indicated for reconstruction of the temporomandibular joint.  Patients should be considered if they have one or more of the following conditions:  1) Inflammaotry arthritis involving the temporomandibular joint not responsive to other modalities of treatment; 2) Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; 3) Failed tissue graft; 4) Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion.
P980053||CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|||N|12/31/1998|09/13/1999|99M-4278|10/15/1999|APPR|This device is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
P990001||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2|NVZ|CV|||N|01/09/1999|09/27/1999|99M-4281|10/20/1999|APPR|Approval for the Diva Platform Implantable Pulse Generators and the ProVit III Application Software (version 3.3.2) including the Diamond II Model 820 PUlse Generator; the Ruby II Model 720 Pulse Generator; the Topaz II Model 520 Pulse Generator; the Jade II Model 220 Pulse Generator; the Vita DDR Moel 810 Pulse Generator; the Vita DDD Model 710 Pulse Generator; the Vita VVIR Model 310 Pulse Generator.
P990002||ROCHESTER MEDICAL CORP.|ONE ROCHESTER MEDICAL DR.||STEWARTVILLE|MN|55976||Transurethral occlusion insert, urinary incontinence-control, female|FEMSOFT URETHRAL INSERT|OCK|GU|||N|01/19/1999|09/30/1999|99M-4330|10/15/1999|APPR|The device is indicated for the management of stress urinary incontinence in adult females.
P990004||FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE, USP|LMF|SU|||N|01/22/1999|09/30/1999|99M-4776||APPR|Approval for the SURGIFOAM Absorbable Gelatin Sponge, U.S.P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
P990008||COOK, INC.|925 SOUTH CURRY PIKE|P.O. BOX 489|BLOOMINGTON|IN|47402||Catheters, transluminal coronary angioplasty, percutaneous|COOK MBC PTCA BALLOON DILATATION CATHETER|LOX|CV|||N|02/11/1999|09/27/1999|99M-4276|10/18/1999|APWD|Approval for the Cook(R) MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure).  This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for th epurpose of improving myocardial perfusion.
P990009||BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Absorbable collagen hemostatic agent with thrombin|FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT|PMX|SU|||N|02/22/1999|12/08/1999|00M-1229|12/08/1999|APPR|THE DEVICE IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P990010||AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX EXCIMER LASER SYSTEM MODEL C STAR|LZS|OP|||N|02/23/1999|11/19/1999|00M-1447|08/18/2000|APPR|Approval for the VISX Excimer Laser System Model C (STAR S2) which included the right to reference information contained in P930016 from VISX, Inc., of Santa Clara, CA.  This device is indicated to perfrom LASIK:  1) in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from 0 to -14.0 diopters (D) with or without -0.5 D to -5.0 D of astigmatism; and 2) in patients with documented evidence of a change in manifest refraction of less than or equalto 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination.
P990012||ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG|LOM|MI|||N|03/04/1999|06/01/2001|01M-0507|11/14/2001|APPR|APPROVAL FOR THE ELECSYS. HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG.  THE DEVICES ARE INDICATED FOR:  ELECSYS HBSAG IMMUNOASSAY IS AN IMMUNOASSAY FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA-K3, SODIUM CITRATE).  ASSAY RESULTS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B.  IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD.  THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 IMMUNOASSAY SYSTEM.  ELECSYS HBSAG CONFIRMATORY IS AN IMMUNOASSAY FOR THE IN VITRO QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA-K3, SODIUM CITRATE) SAMPLES REPEATEDLY REACTIVE WHEN TESTED WITH ELECSYS 2010 HBSAG IMMUNOASSAY.  PRECICONTROL HBSAG IS USED FOR QUALITY CONTROL OF THE ELECSYS HBSAG IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY SYSTEM WHEN TESTING HUMAN SERUM.  THE PERFORMANCE OF THE PRECICONTROL HBSAG HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAY.
P990013||STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|||N|03/05/1999|04/02/2000|00M-1230||APPR|This device is indicated for the correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification cataract extraction.  The lens is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
P990014||Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|||N|03/04/1999|11/12/1999|99M-5135|12/10/1999|APPR|This device is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed by extracapsular extraction methods.  The lens is intended for placement in the capsular bag.
P990015||LIFECORE BIOMEDICAL, INC.|3515 LYMAN BLVD.||CHASKA|MN|55318||BARRIER, ABSORABLE, ADHESION|INTERGEL ADHESION PREVENTION SOLUTION|MCN|OB|||Y|03/08/1999|11/16/2001|01M-0523|11/21/2001|APWD|APPROVAL FOR THE GYNECARE INTERGEL ADHESION PREVENTIION SOLUTION.  THE DEVICE IS INDICATED FOR USE IN PATIENTS UNDERGOING OPEN, CONSERVATIVE GYNECOLOGIC SURGERY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE TO REDUCE POST-SURGICAL ADHESIONS.  GYNECARE INTERGEL ADHESION PREVENTION SOLUTION IS ALSO INTENDED TO REDUCE THE LIKELIHOOD OF DEVELOPING MODERATE OR SEVERE POSTOPERATIVE ADNEXAL ADHESIONS IN THESE PATIENTS.
P990016||CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||Bone sonometer|MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0|MUA|RA|||N|03/08/1999|01/07/2000|00M-0580|02/15/2000|APRL|Approval to perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid for the diagnosis of osteoporosis and other medical conditions leading to reduced bone density and, ultimately, for the determination of fracture risk.
P990017||Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM|MIH|CV|||Y|03/15/1999|09/28/1999|99M-4280|10/18/1999|APWD|Approval for the ANCURE Tube and Bifurcated Systems and the ANCURE Iliac Balloon Catheter (9 mm to 14 mm sizes).  This device has the following indications for use:  The ANCURE(TM) Tube System is indicated for the endovascular treatment of infrarenal abdominal aortic aneurysms (AAA) in patients having adequate iliac/femoral access, infrarenal non-aneurysmal neck length of at least 15 mm and a diameter of no greater than 26mm, distal segment neck length of 12mm and diameter of no greater than 26mm, and morphology suitable for endovascular repair.  The ANCURE(TM) Bifurcated System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients having adequate iliac/femoral access, infrarenaln non-aneurysmal neck length of at least 15mm and a diameter of no greater than 26mm, distal segment lengths of at least 20mm and diameters no greater than 13.4mm, and morphology suitable for endovascular repair.  The ANCURE(TM) Iliac Balloon Catheter is indicated for use in securing the attachment systems in the iliac arteries and/or to expand vascular prosthesis limbs of the ANCURE(TM) ENDOGRAFT(R) Vascular Prosthesis.
P990018||MENICON CO. LTD.|269 A BALLARDVALE STREET||WILMINGTON|MA|01887||Lens,contact(rigid gas permeable)-extended wear|MENICON Z RIGID GAS PERMEABLE CONTACT LENS|MWL|OP|||N|03/18/1999|07/11/2000|00M-1414|07/25/2000|APPR|APPROVAL FOR THE MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE LENS.  MENICON Z(TM) (TISILFOCON A) SPHERICAL OR ASPHERIC LENSES AND NON-PRISM BALLAST TORIC LENSES ARE INDICATED FOR EXTENDED WEAR (FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OF THE LENSES, AS RECOMMENDED BY THE EYECARE PRACTITIONER) FOR THE CORRECTION OF REFRACTIVE ERROR (MYOPIA, HYPEROPIA, PRESBYOPIA AND/OR ASTIGMATISM) IN NON-APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENS MAY BE DISINFECTED USING A...
P990019||DUSA PHARMACEUTICALS, INC.|25 UPTON DR.||WILMINGTON|MA|01887||SYSTEM, LASER, PHOTODYNAMIC THERAPY|BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR|MVF|SU|||N|03/16/1999|12/03/1999|00M-1613|11/14/2000|APPR|The devices is indicated for use in Photodynamic Therapy with Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% for the treatment of non-hyperkeratotic actinic keratoses of the face or scalp.
P990020||Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|||Y|04/12/1999|09/28/1999|99M-4331|10/15/1999|APWD|This device is indicated for the endovascular treatment of infra renal abdominal aortic or aorto-iliac aneurysms having: 1) Adequate iliac/femoral access; 2) Infrarenal non-aneurysmal neck length of at least 1 cm at the proximal and distal ends of the aneurysm, and a vessel diameter 10-20% smaller than labeled device diameter; 3) Morphology suitable for endovascular repair; and 4) One of the following: A diameter > 5cm; A diameter of 4-5cm and has increased in size by 0.5cm in the last 6 months; or Twice the diameter of the normal infrarenal aorta.
P990021||CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, PHOTODYNAMIC THERAPY|DIOMED 630 PDT LASER|MVF|SU|||N|05/04/1999|06/30/2000|00M-1387|07/14/2000|APPR|APPROVAL FOR THE DIOMED 630 PDT LASER, MODEL T2USA.  THIS DEVICE IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN (PORFIMER SODIUM) AS A SOURCE OF ACTIVATION OF PHOTOFRIN FOR: A) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER, OR OF PATIENTS WITH PARTIALLY OBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIAN, CANNOT BE SATISFACTORILY TREATED WITH ND:YAG LASER THERAPY.  B) REDUCTION OF OBSTRUCTING AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLET
P990023||ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|||N|05/07/1999|02/24/2000|00M-0809|08/03/2000|APPR|
P990025||BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|||N|05/24/1999|06/15/2000|00M-1388|07/11/2000|APPR|APPROVAL FOR THE NAVI-STAR(R) DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER.  THE NAVI-STAR DIAGNOSTIC/ABLATION CATHETER, AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR CARDIAC MAPPING, AND WHEN USED WITH A COMPATIBLE RADIO FREQUENCY GENERATOR IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER FOR:* INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; INCLUDING PERSISTEND JUNCTIONAL RE-ENTRANT TACHYCARDIA (PJRT) ...
P990026||ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|NCT|CH|||Y|06/01/1999|03/22/2001|01M-0371|08/29/2001|APWD|APPROVAL FOR THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER.  THE DEVICE IS INDICATED FOR: THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES.  THE DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES.  THE GLUCOWATCH BIOGRAPHER IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.  THE BIOGRAPHER IS INDICATED FOR USE IN THE DETECTION AND ASSESSMENT OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS.  INTERPRETATION OF BIOGRAPHER RESULTS WHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P990027||TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)|LZS|OP|||N|05/28/1999|02/23/2000|00M-1597|11/03/2000|APPR|APPROVAL FOR THE TECHNOLAS(R) 217A EXCIMER LASER SYSTEM.  THE DEVICES IS INDICATED TO PERFORM LASER IN-SITU KERATOMILEUSIS (LASIK):  1) IN TREATMENTS FOR THE REDUCTION OR ELIMINATINO OF MYOPIA (NEARSIGHTEDNESS) FROM -1.00 TO -7.00 DIOPTERS D WITH LESS THAN -3.00 D ASTIGMATISM;  2) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS AS DEMONSTRATED BY A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS); AND,  3) IN PATIENTS 21 YEARS OF AGE OR OLDER.
P990028||GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Sealant,polymerizing|FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT|NBE|AN|||N|06/07/1999|05/26/2000|00M-1507|09/11/2000|APWD|APPROVAL FOR THE FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT.
P990030||ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Absorbable collagen hemostatic agent with thrombin|VITAGEL SURGICAL HEMOSTAT|PMX|SU|||N|06/07/1999|06/13/2000|00M-1368|07/12/2000|APWD|APPROVAL FOR COSTASIS(R) SURGICAL HEMOSTAT AND DYNASTAT(TM) SURGICAL HEMOSTAT.  THIS DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P990033||CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15|NPZ|DE|||N|06/24/1999|10/25/1999|99M-4692|11/04/1999|APWD|Approval for PepGen P-15.  This device is intended to be used for intrabony periodontal osseous defects due to moderate or severe peridontitis.
P990034||MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC ISOMED INFUSION SYSTEM|LKK|HO|||N|06/28/1999|07/21/2000|00M-1495|09/21/2000|APPR|APPROVAL FOR THE MEDTRONIC(R) ISOMED(R) CONSTANT FLOW INFUSION SYSTEM.  THIS DEVICE IS INDICATED FOR USE WHEN PATIENT THERAPY REQUIRES THE CHRONIC INFUSION OF APPROVED DRUGS OR FLUIDS.
P990035||BEAM-MED LTD|8 HALAPID STR.||PETACH TIKVA||49170||Bone sonometer|THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER|MUA|RA|||N|06/30/1999|01/20/2000|00M-0577|02/16/2000|APRL|The Sumlight Omnisense Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the velocity of ultrasound waves ("Speed of Sound" or "SOS in m/sec") propagating along the distal one-third of the radius bone.  SOS provides a measure of skeletal fragility.  The output is also expressed as a T-score and Z-score and can be used in conjunction with other clinical risk factors as an aid to the physician in diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.The SOS measured by Omnisense has a precision error low enough in comparison with the expected annual change in a pateints' measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).
P990036||CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014||Intravascular radiation delivery system|CORDIS CHECKMATE(TM) SYSTEM|MOU|CV|||Y|07/01/1999|11/03/2000|00M-1650|12/13/2000|APWD|APPROVAL FOR THE CORDIS CHECKMATE(TM) SYSTEM.  THE DEVICE IS INDICATED FOR THE DELIVERY OF THERAPEUTIC DOSES OF GAMMA RADIATION FOR THE PURPOSE OF REDUCING IN-STENT RESTENOSIS.  THE SYSTEM IS FOR USE IN THE TREATMENT OF NATIVE CORONARY ARTERIES (2.75 - 4.0 MM IN DIAMETER AND LESIONS UP TO AND INCLUDING 45 MM IN LENGTH) WITH IN-STENT RESTENOSIS FOLLOWING PERCUTANEOUS REVASCULARIZATION USING CURRENT INTERVENTIONAL TECHNIQUES.
P990037||Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|||N|06/30/1999|06/22/2000|00M-1390|07/12/2000|APPR|APPROVAL FOR THE VASCULAR SOLUTIONS DUETT(TM) SEALING DEVICE.  THIS DEVICE IS INDICATED FOR SEALING FEMORAL ARTERIAL PUNCTURE SITES AND REDUCING TIME TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F-9F INTRODUCER SHEATH WITH AN OVERALL LENGTH NOT EXCEEDING 15.2 CM.
P990038||DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI MAK-2 PLUS ASSAY|LOM|MI|||N|07/02/1999|03/30/2001|01M-0451|10/09/2001|APPR|APPROVAL FOR THE DIASORIN ETI-MAK-2 PLUS ASSAY.  THE DEVICE IS INDICATED FOR: ETI-MAK-2 PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN).  THE ETI-MAK-2 PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT.  THE DETECTION OF HBSAG IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HEPATITIS B VIRUS (HBV) INFECTION, EITHER ACUTE OR CHRONIC.  FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE.  THE ETI-MAK-2 PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.  THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.
P990039||QUIDEL CORP.|2981 COPPER RD.||SANTA CLARA|CA|||Tester,acoustic,bone quality|QUS-2 (TM) CALCANEAL ULTRASONOMETER|NAN|RA|||N|07/14/1999|08/01/2000|00M-1437|08/16/2000|APWD|APPROVAL FOR THE QUS-2 CALCANEAL ULTRASONOMETER.  THE QUS-2 ULTRASONOMETER IS A MEDICAL DEVICE THAT UTILIZES QUANTITATIVE ULTRASOUND FOR EVALUATION OF THE CALCANEUS.  ITS BUA (BROADBAND ULTRASOUND ATTENUATION) VALUE IS INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF OSTEOPOROSIS AND IN THE DETERMINATION OF RISK OF SUBSEQUENT ATRAUMATIC FRACTURE.
P990040||CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM|KGG|NE|||N|07/16/1999|09/25/2000|00M-1569|10/20/2000|APPR|APPROVAL FOR THE TRUFILL(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM.  THE DEVICE IS INDICATED FOR THE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WHEN PRESURGICAL DEVASCULARIZATION IS DESIRED.
P990041||DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285||DIASORIN ETI-AB-EBK PLUS ASSAY||MI|||N|07/02/1999|03/30/2001|01M-0452|10/09/2001|APPR|APPROVAL FOR THE DIASORIN ETI-AB-EBK PLUS ASSAY.  THE DEVICE IS INDICATED FOR:  ETI-AB-EBK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN).  THE ETI-AB-EBK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT.  THE DETECTION OF ANTI-HBE IS INDICATIVE OF LABORATORY DIAGNOSIS FOR SEROCONVERSION AND PROGRESSION TO HEPATITIS B VIRUS (HBV) CLEARANCE.  A REACTIVE TEST IS PRESUMPTIVE LABORATORY EVIDENCE OF HBV SEROCONVERSION.  FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE.  THE ANTI-HBE ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.
P990042||DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-AUK PLUS ASSAY|LOM|MI|||N|07/02/1999|03/30/2001|01M-0453|10/09/2001|APPR|APPROVAL FOR THE DIASORIN ETI-AB-AUK PLUS ASSAY.  THE DEVICE IS INDICATED FOR: ETI-AB-AUK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ERUM OR PLASMA (EDTA, CITRATE OR HEPARIN).  THE ETI-AB-AUK PLUS IS INTENDED FOR MANUAL USE ONLY.  THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS FOR SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.  ANTI-HBS IS ALSO USED TO ASSESS LABORATORY DIAGNOSIS OF PAST EXPOSURE TO HEPATITIS B IN POTENTIAL HEPATITIS B VACCINE RECIPIENTS AND TO DETERMINE THE PRESENCE OS AN IMMUNE RESPONSE IN VACCINE RECIPIENTS.  THE ANTI-HBS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HVB DISEASE OR THERAPY.
P990043||DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-EBK PLUS ASSAY|LOM|MI|||N|07/02/1999|02/08/2001|01M-0454|10/09/2001|APPR|APPROVAL FOR THE DIASORIN ETI-EBK PLUS ASSAY.  THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF HEPATITIS BE ANTIGEN (HBEAG) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN).  THE ETI-EBK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT.  THE DETECTION OF HBEAG IS INDICATIVE OF ACTIVE HBV REPLICATION, USUALLY CORRELATING WITH VIREMIA.  A REACTIVE TEST IS PRESUMPTIVE LABORATORY EVIDENCE FOR INFECTION WITH HEPATITIS B VIRUS (HBV). FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE.  THE HBEAG ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.
P990044||DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285||DIASORIN ETI-CORE-IGMK PLUS ASSAY||MI|||N|07/02/1999|03/30/2001|01M-0455|10/09/2001|APPR|APPROVAL FOR THE DIASORIN ETI-CORE-IGMK PLUS ASSAY.  THE DEVICE IS INDICATED FOR:  ETI-CORE-IGMK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY(EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN).  THE ETI-CORE-IGMK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT.  THE PRESENCE OF IGM ANTI-HBC, IN THE PRESENCE OF TOTAL ANTIBODY TO HBC (ANTI-HBC) IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR ACUTE INFECTION.  THE ABSENCE OF IGM ANTI-HBC, IN THE PRESENCE OF TOTAL ANTI-HBC, IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR RECOVERY FROM HBV INFECTION.  FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE.  THE ETI-CORE-IGMK PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.  THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.
P990045||DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285||DIASORIN ETI-AB-COREK PLUS ASSAY||MI|||N|07/02/1999|03/30/2001|01M-0456|10/09/2001|APPR|APPROVAL FOR THE DIASORIN ETI-AB-COREK PLUS ASSAY.  THE DEVICE IS INDICATED FOR:  ETI-AB-COREK PLUS IS IAN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN).  THE ETI-AB-COREK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT.  THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR EXPOSURE TO HEPATITIS B VIRUS (HBV) INFECTION .  FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE.  THE ETI-AB-COREK PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.
P990046||MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|||N|07/29/1999|10/13/2000|00M-1570|10/20/2000|APPR|APPROVAL FOR THE ATS OPEN PIVOT BILEAFLET HEART VALVE, STANDARD AORTIC MODEL A500FA 21, 23, 25, 27, AND 29 MM, STANDARD MITROAL MODEL 500DM 29, 31, AND 33 MM, ADVANCED PERFORMANCE (AP) AORTIC MODEL 501DA 18, 20, 22, 24, AND 26 MM, AND AP MITRAL MODEL 510DM 26 AND 28 MM.  THE DEVICE IN INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES.
P990048||CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||SYSTEM, LASER, PHOTODYNAMIC THERAPY|ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER|MVF|SU|||N|08/16/1999|04/12/2000|00M-1300|04/12/2000|APPR|Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
P990049||LUMENIS|3959 WEST 1820 SOUTH||SALT LAKE CITY|UT|84104||SYSTEM, LASER, PHOTODYNAMIC THERAPY|COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM|MVF|SU|||N|08/20/1999|04/12/2000|00M-1299|04/12/2000|APWD|Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
P990050||SPECTRA SCIENCE|11568 SORRENTO VALLEY RD,SUITE|11|SAN DIEGO|CA|92121||ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)|OPTICAL BIOPSY(TM) SYSTEM|MOA|GU|||N|08/24/1999|11/14/2000|01M-0478|10/19/2001|APPR|APPROVAL FOR THE OPTICAL BIOPSY(TM) SYSTEM.  THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO LOWER GASTROINTESTINAL (GI) ENDOSCOPY.  THE DEVICE IS INTENDED FOR THE EVALUATION OF POLYPS LESS THAN 1 CM IN DIAMETER THAT THE PHYSICIAN HAS NOT ALREADY ELECTED TO REMOVE.  THE DEVICE IS ONLY TO BE USED IN DECIDING WHETHER SUCH POLYPS SHOULD BE REMOVED (WHICH INCLUDES SUBMISSION FOR HISTOLOGICAL EXAMINATION).
P990052||VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM|MPV|EN|||N|09/07/1999|08/31/2000|00M-1583|10/27/2000|APPR|APPROVAL FOR THE VIBRANT SOUNDBRIDGE SYSTEM.  THIS DEVICE IS INDICATED FOR PROVIDING A USEFUL LEVEL OF SOUND PERCEPTION TO INDIVIDUALS VIA MECHANICAL STIMULATINO OF THE OSSICLES.  THE VIBRANT SOUNDBRIDGE IS INTENDED FOR USE IN ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS AND DESIRE AN ALTERNATIVE TO AN ACOUSTIC HEARING AID.  PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
P990053||NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|||N|09/21/1999|05/12/2000|00M-1448|08/24/2000|APPR|APPROVAL FOR THE NELLCOR N-400 FETAL OXYGEN SATURATION MONITORING SYSTEM (OXIFIRST(TM) SYSTEM).
P990054||Boston Scientific Corp.|2710 ORCHARD PKWY.||SAN JOSE|CA|95113||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|||N|09/20/1999|03/17/2000|00M-1517|09/26/2000|APWD|The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, RF ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.  In addition, the Chilli Catheter with Tracking is used with the Arrhythmia Mapping and Tracking System to provide catheter location information.
P990055||SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|BAYER IMMUNO 1 COMPLEXED PSA ASSAY|NAF|IM|||N|10/01/1999|09/08/2000|00M-1524|09/26/2000|APPR|APPROVAL FOR THE BAYER IMMUNO 1(TM) COMPLEXED PSA ASSAY.  THE IN VITRO DEVICE IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM ON THE BAYER IMMUNO 1(TM) SYSTEM.  THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER.  BIOPSY OF THE PROSTATE IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THIS DEVICE IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.  THIS DIAGNOSTIC METHOD IS NOT INTENDED FOR USE ON ANY OTHER SYSTEM.
P990056||ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET|MTF|IM|||N|10/04/1999|11/22/2000|00M-1660|12/12/2000|APPR|APPROVAL FOR THE ELECSYS(R) TOTAL PSA IMMUNOASSAY AND ELECSYS(R) TOTAL PSA CALSET.  THE DEVICE, A QUANTITATIVE IN VITRO DIAGNOSTIC TEST FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) IN HUMAN SERUM AND PLASMA IS INDICATED FOR THE MEASUREMENT OF TOTAL PSA IN CONJUNCTION WITH DOGOTA; RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THE TEST ID FURTHER INDICATED FOR SERIAL MEASUREMENT OF TPSA TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.  THE ELECTOCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS(R) 1010 AND 2010 IMMUNOASSAY ANALYZERS.
P990064||MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE|DYE|CV|||N|10/08/1999|07/14/2000|00M-1416|08/03/2000|APPR|APPROVAL FOR THE MOSAIC(R) PORCINE BIOPROSTHESIS, MODELS 305 AND 310 IN THE FOLLOWING SIZES: MODEL 305 (AORTIC) 21, 23, 25, 27 AND 29 MM; MODEL 310 (MITRAL) 25, 27, 29 AND 31 MM.  THIS DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL HEART VALVES.
P990065||SIRTEX MEDICAL LIMITED|UNIT F6 PARKVIEW 16 MARS ROAD||LANE COVE||NSW 2||Microspheres radionuclide|SIR-SPHERES|NAW|RA|||N|10/25/1999|03/05/2002|03M-0010|01/23/2003|APPR|APPROVAL FOR SIR-SPHERES.  THE DEVICE IS INDICATED FOR THE TREATMENT OF UNRESECTABLE METASTATIC LIVER TUMORS FROM PRIMARY COLORECTAL CANCER WITH ADJUVANT INTRA-HEPATIC ARTERY CHEMOTHERAPY (IHAC) OF FUDR (FLOXURIDINE).
P990066||GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|||N|10/29/1999|01/28/2000|00M-0579|02/16/2000|APRL|
P990069||DOT MEDICAL PRODUCTS LTD.|3 BAILY COURT, GREEN STREET||MACCLESFIELD, CHESHIRE||SK10||SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)|MTE|CV|||Y|11/01/1999|11/27/2002|03M-0240|06/24/2003|APPR|APPROVAL FOR THE ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08).  THE ALERT SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION.
P990071||BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR|LPB|CV|||N|11/09/1999|05/31/2000|03M-0045|03/01/2003|APPR|THE STOCKERT 70 RF GENERATOR SYSTEM IS INDICATED FOR USE WITH A BIOSENSE WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER TO DELIVER RF ENERGY DURING CARDIAC ABLATION PROCEDURES.
P990072||WESTCON CONTACT LENS CO., INC.|611 EISENHAUER ST.||GRAND JUNCTION|CO|81505||Lenses, soft contact, extended wear|W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|||N|11/16/1999|08/22/2000|00M-1475|08/31/2000|APWD|APPROVAL FOR THE HORIZON 55 EW AND HORIZON 55 EW WESTINT (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND VISIBILITY TINT).  THESE DEVICES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVEL FOR CLEANING, RINSING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON DISEASED EYES THAT ARE MYOPIC OR HYPEROPIC.  THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 1.50 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.
P990074||Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE BREAST IMPLANTS|FWM|SU|||N|11/16/1999|05/10/2000|01M-0012|01/18/2001|APPR|APPROVAL FOR THE MCGHAN RTV SALINE-FILLED BREAST IMPLANT.
P990075||MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES|FWM|SU|||N|11/12/1999|05/10/2000|01M-0011|01/18/2001|APPR|Approval for the mentor Corporation Saline-Filled and Spectrum Mammary Prostheses.
P990078||SUNRISE TECHNOLOGIES, INC.|3400 W. WARREN AVE.||FREMONT|CA|94538||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|HYPERION LTK SYSTEM|LOI|OP|||N|11/03/1999|06/30/2000|00M-1386|07/11/2000|APPR|APPROVAL FOR THE SUNRISE HYPERION(TM) LTK SYSTEM.  THE DEVICE IS INDICATED FOR TEMPORARY REDUCTION OF HYPEROPIA IN PATIENTS WITH +0.75 TO +2.5 DIOPTERS OF MANIFEST REFRACTION SPHERICLA EQUIVALENT (MRSE) AT THE SPECTACLE PLANE (WITH CYLINDER LESS THAN OR EQUAL TO +-0.75 DIOPTERS) WHO ARE 40 YEARS OF AGE OR OLDER WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 6 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D IN SPHERICAL, AND CYLINDRICAL COMPONENTS OF THE MANIFEST REFRACS
P990080||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A|HQL|OP|||N|11/30/1999|04/05/2001|01M-0173|04/13/2001|APPR|APPROVAL FOR THE CEEON(TM) EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS - MODEL 911A.  THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION.  THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P990081||VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|||N|12/13/1999|11/28/2000|00M-1661|12/12/2000|APPR|APPROVAL FOR THE PATHWAY(TM) HER 2 (CLONE CB11).  THE DEVICE IS A MOUSE MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF C-ERBB-2 ANTIGEN IN SECTIONS OF FORMALIN FIXED, PARAFFIN EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEMISTRY SLIDE STAINING DEVICE.  IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN(R) TREATMENT IS BEING CONSIDERED.
P990085||Johnson & Johnson Vision Care, Inc.|7500 CENTURION PKWY.|SUITE 100|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|||N|12/20/1999|02/16/2001|01M-0149|03/26/2001|APPR|THE VISTAKON SPHERICAL (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS.  THE LENS MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 1.00 DIOPTER OR LESS WHICH DOES NOT INTERFERE WITH VISUAL ACUITY.THE VISTAKON BIFOCAL (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC NOT-APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS.  THE LENS MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 1.00 DIOPTER OR LESS WHICH DOES NOT INTERFERE WITH VISUAL ACUITY.THE VISTAKON TORIC (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC OR HYPEROPIC AND HAVE 10.00 DIOPTERS OR LESS OF ASTIGMATISM. THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS.THE VISTAKON TORIC BIFOCAL (LENEFILCON A) CONTACT LENS IS INDICATED FOR DAILY AND EXTENDED WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT HAVE ASTIGMATISM OF 10.00 DIOPTERS OR LESS.  THE LENS IS INDICATED FOR DAILY WEAR IN APHAKIC PERSONS....
P990086||SANUWAVE, INC.|11680 GREAT OAKS WAY|SUITE 350|ALPHARETTA|GA|30022||Generator, shock-wave, for pain relief|HEALTHTRONICS OSSATRON|NBN|PM|||N|12/30/1999|10/12/2000|01M-0271|06/18/2001|APPR|THIS DEVICE IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE TREATMENT IN PATIENTS WITH CHRONIC PROXIMAL PLANTAR FASCIITIS THAT HAS FAILED TO RESPOND TO CONSERVATIVE TREATMENT.  CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
P000005||MEDITEAM AB|GOTEBORGSVAGEN 74,||SAVEDALEN||S-433|433|SOLUTION, REMOVAL, CARRIES|CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM|LMW|DE|||N|01/10/2000|06/27/2001|01M-0337|08/13/2001|APPR|APPROVAL FOR THE CARISOLV(TM) NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM.  THE DEVICE IS INTENDED FOR THE CHEMO-MECHANICAL SOFTENING AND REMOVAL OF DENTIN CARIES WHEN USED IN CONJUNCTION WITH A DENTAL HANDPIECE.
P000006||COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|||N|01/18/2000|07/14/2000|00M-1415|07/25/2000|APPR|APPROVAL FOR THE MENTOR ALPHA I INFLATABLE PENILE PROSTHESIS.  THIS DEVICE IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.
P000007||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P|DYE|CV|||N|01/27/2000|02/27/2001|01M-0381|09/05/2001|APPR|APPROVAL FOR THE EDWARDS PRIMA(TM) PLUS STENTLESS BIOPROSTHESIS MODEL 2500P, SIZES 21, 23, 25 AND 27 MM.  THE DEVICE IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC AORTIC VALVE USING THE SUBCORONARY IMPLANTATION TECHNIQUE.
P000008||APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|||Y|02/09/2000|06/05/2001|02M-0250|06/03/2002|APPR|APPROVAL FOR THE LAP-BAND. ADJUSTABLE GASTRIC BANDING (LAGB.) SYSTEM.  THE DEVICE IS INDICATED FOR USE IN WEIGHT REDUCTION FOR SEVERELY OBESE PATIENTS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 OR A BMI OF AT LEAST 35 WITH ONE OR MORE SEVERE COMORBID CONDITIONS, OR THOSE WHO ARE 100 LBS. OR MORE OVER THEIR ESTIMATED IDEAL WEIGHT ACCORDING TO THE 1983 METROPOLITAN LIFE INSURANCE TABLES (USE THE MIDPOINT FOR MEDIUM FRAME).  IT IS INDICATED FOR USE ONLY IN SEVERELY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.  PATIENTS WHO ELECT TO HAVE THIS SURGERY MUST MAKE THE COMMITMENT TO ACCEPT SIGNIFICANT CHANGES IN THEIR EATING HABITS FOR THE REST OF THEIR LIVES.
P000009||BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PHYLAX AV ICD SYSTEM|MRM|CV|||N|02/14/2000|09/29/2000|01M-0042|01/23/2001|APPR|APPROVAL FOR THE PHYLAX AV ICD SYSTEM INCLUDING THE PULSE GENERATOR, MODEL NUMBER 122 382 AND PHYLAX AV SOFTWARE CARTRIDGE SWM 1000/I-GAV.2.U, MODEL NUMBER 128 814.  THE DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OR MORE OF THE FOLLOWING SITUATIONS:  1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS DUE TO A VENTRICULAR TACHYARRHYTHMIA  2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT)  NOTE: THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS ID NOT FULLY KNOWN.  SAFETY AND EFFECTIVENESS STUDIES FOR THIS INDICATION HAVE NOT BEEN CONDUCTED.
P000010||Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0|MZP|MI|||Y|02/23/2000|07/05/2001|02M-0082|02/27/2002|APWD|APPROVAL FOR THE AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0.  THE DEVICE IS INDICATED FOR: THE QUALITATIVE DETECTION OF HCV RNA IN HUMAN SERUM OR PLASMA FROM BLOOD COLLECTED IN EDTA (EDTA PLASMA).  THE TEST DETECTS BY REVERSE-TRANSCRIBING TARGET HCV RNA INTO CDNA, AMPLIFYING CDNA BY POLYMERASE CHAIN REACTION (PCR), HYBRIDIZING AMPLIFIED CDNA WITH AN OLIGONUCLEOTIDE PROBE THAT BINDS ENZYME, AND CATALYZING CONVERSION OF SUBSTRATE TO A COLORED PRODUCT THAT IS RECOGNIZED BY A MICROWELL PLATE READER.  THE AMPLICOR HCV TEST, V2.0 IS INDICATED FOR PATIENTS WHO HAVE EVIDENCE OF LIVER DISEASE AND ANTIBODY EVIDENCE OF HCV INFECTION, AND WHO ARE SUSPECTED TO BE ACTIVELY INFECTED WITH HCV.  DETECTION OF HCV RNA INDICATES  THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE INFECTION.
P000011||ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM|MAF|CV|||N|02/25/2000|09/29/2000|01M-0055|03/09/2001|APWD|APPROVAL FOR THE BIODIVYSIO(TM) AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM.  THE DEVICE IS INTENDED FOR USE IN SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >= 3.0 MM TO <= 4.0 MM AND INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER.  LONG TERM OUTCOME (BEYOND SIX MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P000012||Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0|MZP|MI|||Y|02/29/2000|07/03/2001|02M-0083|02/27/2002|APWD|APPROVAL FOR THE COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0.  THE DEVICE IS INDICATED FOR: THE QUALITATIVE DETECTION OF HCV RNA IN HUMAN SERUM OR PLASMA FROM BLOOD COLLECTED IN EDTA (EDTA PLASMA).  THE TEST DETECTS BY REVERSE-TRANSCRIBING TARGET HCV RNA INTO CDNA, AMPLIFYING CDNA BY POLYMERASE CHAIN REACTION (PCR), HYBRIDIZING AMPLIFIED CDNA WITH AN OLIGONUCLEOTIDE PROBE THAT BINDS ENZYME, AND CATALYZING CONVERSION OF SUBSTRATE TO A COLORED PRODUCT THAT IS RECOGNIZED BY THE COBAS AMPLICOR ANALYZER.  THE COBAS AMPLICOR HCV TEST, V2.0 IS INDICATED FOR PATIENTS WHO HAVE EVIDENCE OF LIVER DISEASE AND ANTIBODY EVIDENCE OF HCV INFECTION, AND WHO ARE SUSPECTED TO BE ACTIVELY INFECTED WITH HCV.  DETECTION OF HCV RNA INDICATES THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE HCV INFECTION.
P000013||HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRIDENT SYSTEM|MRA|OR|||N|03/02/2000|02/03/2003|03M-0337|07/30/2003|APPR|APPROVAL FOR THE OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM.  THESE DEVICES ARE INDICATED FOR PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO PAINFUL DISABLING JOINT DISEASE OF THE HIP RESULTING FROM NON-INFLAMMATORY DEGENERATIVE ARTHRITIS (OSTEOARTHRITIS, AVASCULAR NECROSIS, TRAUMATIC ARTHRITIS, SLIPPED CAPITAL EPIPHYSIS, PELVIC FRACTURE, FEMORAL FRACTURE, FAILED FRACTURE FIXATION, OR DIASTROPHIC VARIANT).
P000014||Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS|LOM|MI|||N|03/02/2000|09/29/2000|00M-1658|12/12/2000|APPR|APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS.  THE DEVICE IS INDICATED FOR:  THE QUALITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM.  ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATINO OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.
P000015||Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Implant, auditory brainstem|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM|MHE|EN|||Y|03/29/2000|10/20/2000|00M-1659|12/12/2000|APPR|APPROVAL FOR THE NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI) SYSTEM, WHICH IS INTENDED TO RESTORE USEFUL HEARING VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS.  THE DEVICE IS INDICATED FOR INDIVIDUALS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN DIAGNOSED WITH NEUROFIBROMATOSIS TYPE 2 (NF2).  IMPLANTATION MAY OCCUR DURING FIRST OR SECOND-SIDE TUMOR REMOVAL, OR IN PATIENTS WITH PREVIOUSLY REMOVED ACOUSTIC TUMORS BILATERALLY.  BECAUSE THE SURGICAL PROCEDURE FOR TUMOR EXCISION AND ELECTRODE PLACEMENT ELIMINATES RESIDUAL HEARING, PREOPERATIVE AUDIOLOGICAL CRITERIA ARE NOT RELEVANT.  PROSPECTIVE IMPLANT RECIPIENTS AND THEIR FAMILIES SHOULD HAVE APPROPRIATE EXPECTATIONS, REGARDING THE POTENTIAL BENEFITS OF AN AUDITORY BRAINSTEM IMPLANT AND SHOULD BE HIGHLY MOTIVATED TO PARTICIPATE IN THE POSTOPEARATIVE REHABILITATION PROCESS.
P000016||GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES|8880 GORMAN ROAD||LAUREL|MD|20723||OXIMETER, FETAL PULSE|COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR|MMA|OB|||N|04/05/2000|02/09/2001|01M-0329|08/02/2001|APWD|APPROVAL FOR THE COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITN INTEGRATED FETAL OXYGEN SATURATION MONITORING, COROMETRICS FETAL PATIENT MOFULE, AND THE NELLCOR OXIFIRST(TM) FS14 SENSOR.  THE 120 F-SERIES SYSTEM CONTINUOUSLY MONITORS INTRAPARTUM FETAL OXYGEN SATURATION (FSPO2) AND IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE (FHR) MONITORING IN THE PRESENCE OF A NONREASSURING FETAL HEART RATE PATTERN.  IT SHOULD ONLY BE USED AFTER MATERNAL MEMBRANES HAVE RUPTURED AND ON A SINGLETON FETUS IN VERTEX PRESENTATION WITH A GESTATIONAL AGE GREATER THAN OR EQUAL TO 36 WEEKS.
P000018||BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH (TM) SYSTEM|MOU|CV|||Y|04/17/2000|11/03/2000|00M-1649|12/13/2000|APPR|APPROVAL FOR THE BETA-CATH(TM) SYSTEM.  THE DEVICE IS INDICATED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS (TREATABLE WITH A 20 MM BALLOON) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.
P000020||Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE|LPB|CV|||N|05/04/2000|11/29/2000|01M-0460|10/11/2001|APPR|APPROVAL FOR THE STINGER(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE.  THE DEVICE IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS, AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.
P000021||SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE|LTJ|IM|||N|06/05/2000|07/05/2001|01M-0310|07/23/2001|APPR|APPROVAL FOR THE DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE.  THE DEVICE IS INDICATED FOR THE FOLLOWING:  THE PSA METHOD FOR THE DIMENSION(R) CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM:  1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN AGED 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER.  2) AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
P000022||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM|MAF|CV|||N|05/30/2000|10/16/2000|01M-0039|01/31/2001|APWD|APPROVAL FOR THE MEDTRONIC AVE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) CORONARY STENT DELIVERY SYSTEM AND THE MEDTRONIC AVE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE (RX) CORONARY STENT DELIVERY SYSTEM.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL  DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM.
P000023||NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES|LZD|DE|||N|06/20/2000|01/05/2001|01M-0255|06/11/2001|APPR|APPROVAL FOR THE TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM.  THE DEVICE IS INDICATED FOR RECONSTRUCTION OF THE TEMPOROMANDIBULAR JOINT.  PATIENTS SHOULD BE CONSIDERED IF THEY HAVE ONE OR MORE OF THE FOLLOWING CONDITIONS:  1) INFLAMMATORY ARTHRITIS INVOLVING THE TEMPOROMANDIBULAR JOINT NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT  2) RECURRENT FIBROUS AND/OR BONY ANKYLOSIS NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT  3) FAILED TISSUE GRAFT  4) FAILED ALLOPLASTIC JOINT RECONSTRUCTION  5) LOSS OF VERTICAL MANDIBULAR HEIGHT AND/OR OCCLUSAL RELATIONSHIP DUE TO BONE RESORPTION, TRAUMA, DEVELOPMENTAL RELATIONSHIP DUE TO BONE RESORPTION, TRAUMA, DEVELOPMENTAL ABNORMALITY, OR PATHOLOGIC LESION.
P000025||MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|||N|06/29/2000|08/20/2001|02M-0006|01/11/2002|APPR|APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (COMBI 40+).  THE DEVICE IS INTENDED TO PROVIDE THE OPPORTUNITY TO DETECT AND RECOGNIZE AUDITORY INFORMATION THROUGH ELECTRICAL STIMULATION OF THE AUDITORY NERVE FOR SERVER TO PROFOUNDLY HEARING-IMPAIRED INDIVIDUALS WHO OBTAIN LITTLE OR NO BENEFIT FROM CONVENTIONAL ACOUSTIC AMPLIFICATION IN THE BEST-AIDED CONDITION.  THE COMBI 40+ IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS:  ADULTS OF EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE BILATERAL, SENSORINEURAL HEARING IMPAIRMENT AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS.  THESE INDIVIDUALS TYPICALLY DEMONSTRATE BILATERAL SEVERE TO PROFOUND SENSORINEURAL HEARING LOSS DETERMINED BY A PURE TONE AVERAGE OF 70 DB OR GREATER AT 500 HZ, 1000 HZ, AND 2000 HZ.  LIMITED BENEFIT FROM AMPLIFICATION IS DEFINED BY TEST SCORES OF 40% CORRECT OR LESS IN BEST-AIDED LISTENING CONDITION ON CD RECORDED TESTS OF OPEN-SET SENTENCE RECOGNITION HEARING IN NOISE TEST (HINT) SENTENCES.  CHILDREN AGED EIGHTEEN (18) MONTHS TO SEVENTEEN (17) YEARS ELEVEN (11) MONTHS MUST DEMONSTRATE A PROFOUND, BILATERAL SENSORINEURAL HEARING LOSS WITH THRESHOLDS OF 90 DB OR GREATER AT 1000HZ.  IN YOUNGER CHILDREN, LITTLE OR NO BENEFIT IS DEFINED BY LACK OF PROGRESS IN THE DEVELOPMENT OF SIMPLE AUDITORY SKILLS IN CONJUNCTION WITH APPROPRIATE AMPLIFICATION AND PARTICIPATION IN INTENSIVE AURAL HABILITATION OVER A THREE (3) TO SIX (6) MONTH PERIOD.  IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS < 20% CORRECT ON THE MULTI-SYLLABIC LEXICAL NEIGHBORHOOD TEST (MLNT) OR LEXICAL NEIGHBORHOOD TEST (LNT), DEPENDING UPON THE CHILD'S COGNITIVE ABILITY AND LINGUISTIC SKILLS.  A THREE (3) TO SIX (6) MONTH HEARING AID TRIAL IS REQUIRED FOR CHILDREN WITHOUT PREVIOUS EXPERIENCE WITH HEARING AIDS.  RADIOLOGICAL EVIDENCE OF COCHLEAR OSSIFICATION MAY JUSTIFY A SHORTER TRIAL WITH AMPLIFICATION.
P000026||STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||Intraocular pressure lowering implant|STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20|OGO|OP|||N|07/07/2000|07/12/2001|01M-0307|07/23/2001|APPR|APPROVAL FOR THE MODEL CGDD-20 AQUAFLOW(TM) COLLAGEN DRAINAGE DEVICE.  THE DEVICE IS INDICATED FOR THE MAINTENANCE OF A SUB-SCLERAL SPACE FOLLOWING NON-PENETRATING DEEP SCLERECTOMY USED TO FACILITATE AQUEOUS OUTFLOW FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA WHERE INTRAOCULAR PRESSURE REMAINS UNCONTROLLED WHILE ON MAXIMALLY TOLERATED MEDICAL THERAPY.
P000027||ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK|LTJ|IM|||N|07/07/2000|12/12/2000|00M-1683|01/03/2001|APPR|APPROVAL FOR THE ELECSYS(R) FREE PSA IMMUNOASSAY FOR ELECSYS 1010 AND 2010 IMMUNOASSAY ANALYZERS.  THE DEVICE IS INDICATED FOR: THE IN VITRO QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN IN HUMAN SERUM AND PLASMA.  THE ELECSYS FREE PSA IMMUNOASSAY IS INDICATED FOR MEASUREMENT OF FPSA IN CONJUNCTION WITH THE ELECSYS TOTAL PSA ASSAY TO DEVELOP A RATIO (% FPSA) OF FPSA TO TPSA.  THIS RATIO IS USEFUL WHEN USED IN CONJUNCTION WITH THE ELECSYS TOTAL PSA TEST AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIOND IN MEN AGE 50 YEARS OR OLDER WHO HAVE A DIGITAL RECTOAL EXAMINATION (DRE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND AN ELECSYS TOTAL PSA VALUE IN THE RANGE 4 NG/ML TO 10 NG/ML.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THE ELECTROCHEMILUMINESCENE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 1010 AND 2010 IMMUNOASSAY ANALYZERS.
P000028||Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|AFFINITY (TM) CAGE SYSTEM|MAX|OR|||Y|07/11/2000|06/13/2002|03M-0532|11/24/2003|APRL|APPROVAL FOR THE AFFINITY CAGE SYSTEM.  THIS DEVICE IS INDICATED FOR ANTERIOR CERVICAL INTERBODY FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH CERVICAL DISC DISEASE AT ONE LEVEL FROM THE C2-C3 DISC TO THE C7-T1 DISC.  CERVICAL DISC DISEASE IS DEFINED AS INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY WITH HERNIATED DISC AND/OR OSTEOPHYTE FORMATION ON POSTERIOR VERTEBRAL ENDPLATES PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION CONFIRMED BY RADIOGRAPHIC STUDIES.  AFFINITY IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN, ANTERIOR APPROACH.
P000029||VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL                                         REN|LNM|GU|||Y|07/11/2000|09/24/2001|01M-0439|10/01/2001|APPR|APPROVAL FOR DEFLUX INJECTABLE GEL.  THE DEVICE IS INDICATED FOR TREATMENT OF CHILDREN WITH VESICOURETERAL REFLUX (VUR) GRADES II-IV.
P000030||Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|||N|07/18/2000|10/12/2001|01M-0480|10/19/2001|APPR|APPROVAL FOR THE FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES.  THE DEVICE IS INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM.  THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR FOR 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  LENSES SHOULD BE REPLACED EVERY MONTH AND WHEN REMOVED BETWEEN REPLACEMENT TIMES MUST BE CLEANED AND DISINFECTED WITH A CHEMICAL, NOT HEAT, DISINFECTION SYSTEM BEFORE REINSERTION.
P000032||CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM|MNB|OB|||N|07/27/2000|04/20/2001|01M-0412|09/24/2001|APPR|APPROVAL FOR THE HEROPTION(TM) UTERINE CRYOBLATION THERAPY(TM) SYSTEM.  THE DEVICE IS A CLOSED-CYCLE CRYOSURGICAL DEVICE INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
P000033||MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|INTRA COIL SELF-EXPANDING PERIPHERAL STENT|NIP|CV|||Y|08/03/2000|04/03/2002|02M-0235|05/24/2002|APPR|APPROVAL FOR THE INTRACOIL SELF-EXPANDING PERIPHERAL STENT.  THIS DEVICE IS INDICATED FOR IMPROVING PERIPHERAL LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE DUE TO STENOTIC LESIONS (LENGTH <= 15 CM) OR OCCLUSIVE LESIONS (LENGTH <= 12 CM) IN FEMOROPOPLITEAL ARTERIES, TO THE BIFURCATION OF THE TIBIAL ARTERY, WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 7.8 MM.
P000035||NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA-EMINENCE PROSTHESIS(TM)|MPI|DE|||N|06/20/2000|02/27/2001|01M-0210|05/14/2001|APPR|APPROVAL FOR THE TMJ FOSSA-EMINENCE PROSTHESIS(TM).  THE DEVICE IS INDICATED FOR USE IN TREATMENT OF SEVERE TEMPOROMANDIBULAR JOINT DISEASE DUE TO: 1) INFLAMMATORY ARTHRITIS INVOLVING THE TEMPOROMANDIBULAR JOINT NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT,  2) RECURRENT FIBROSIS AND/OR BONY ANKYLOSIS NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT,  3) FAILED TISSUE GRAFT,  4) FAILED ALLOPLASTIC JOINT RECONSTRUCTION,  5) INTERNAL DERANGEMENT CONFIRMED TO BE PATHOLOGICAL IN ORIGIN BY BOTH CLINICAL OBSERVATION AND RADIOGRAPHIC FINDINGS, WHERE THE PATIENT HAS MODERATE TO SEVERE PAIN AND/OR DISABLING DYSFUNCTION AND HAS NOT RESPONDED TO LESS INVASIVE CONVENTIONAL THERAPY.
P000036||SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|||N|08/25/2000|09/28/2001|01M-0498|10/31/2001|APPR|APPROVAL FOR THE DERMAGRAFT(R).  THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF FULL-THICKNESS DIABETIC FOOT ULCERS GREATER THAN SIX WEEKS DURATION WHICH EXTEND THROUGH THE DERMIS, BUT WITHOUT TENDON MUSCLE, JOINT CAPSULE OR BONE EXPOSURE.  DERMAGRAFT(R) SHOULD BE USED IN CONJUNCTION WITH STANDARD WOUND CARE REGIMENS AND IN PATIENTS THAT HAVE ADEQUATE BLOOD SUPPLY TO THE INVOLVED FOOT.
P000037||On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA|LWQ|CV|||N|09/01/2000|05/30/2001|01M-0270|06/19/2001|APPR|APPROVAL FOR THE ON-X. PROSTHETIC HEART VALVE, MODEL ONXA IN THE AORTIC POSITION INCLUDING SIZES 19, 21, 23, 25, AND 27/29 MM.  THIS DEVICE IS INDICATED FOR REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE AORTIC POSITION.
P000039||St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM|MLV|CV|||N|09/01/2000|12/05/2001|02M-0271|06/27/2002|APPR|APPROVAL FOR THE AMPLATZER SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM.  THE AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE IS INDICATED FOR THE OCCLUSION OF ATRIAL SEPTAL DEFECTS (ASD) IN SECUNDUM POSITION.  THE ASO DEVICE IS ALSO INDICATED IN PATIENTS WHO HAVE UNDERGONE A FENESTRATED FONTAN PROCEDURE AND WHO NOW REQUIRE CLOSURE OF THE FENESTRATION.  PATIENTS INDICATED FOR ASD CLOSURE HAVE ECHOCARDIOGRAPHIC EVIDENCE OF OSTIUM SECUNDUM ATRIAL SEPTAL DEFECT AND CLINICAL EVIDENCE OF RIGHT VENTRICULAR VOLUME OVERLOAD (I.E., 1.5:1 DEGREE OF LEFT TO RIGHT SHUNT OR RV ENLARGEMENT).  THE AMPLATZER EXCHANGE SYSTEM IS INTENDED FOR THE REMOVAL OF AN AMPLATZER DELIVERY SHEATH AND SUBSEQUENT EXCHANGE FOR AN AMPLATZER DELIVERY SHEATH OF EQUAL OR LARGER DIAMETER.
P000040||Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM|MNB|OB|||N|09/25/2000|04/20/2001|01M-0578|12/21/2001|APPR|APPROVAL FOR THE HYDRO THERMABLATOR(R) ENDOMETRIAL ABLATION SYSTEM.  THE DEVICE IS INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILD BEARING IS COMPLETE.
P000041||RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|RAPIDSCREEN RS-2000|MYN|RA|||Y|10/10/2000|07/12/2001|01M-0306|07/23/2001|APPR|APPROVAL FOR THE RAPIDSCREEN(TM) RS-2000.  THE DEVICE IS A COMPUTER-AIDED DETECTION (CAD) SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON DIGITIZED FRONTAL CHEST RADIOGRAPHS.  IT IDENTIFIES FEATURES ASSOCIATED WITH SOLITARY PULMONARY NODULES FROM 9 TO 30 MM IN SIZE, WHICH COULD REPRESENT EARLY-STAGE LUNG CANCER.  THE DEVICE IS INTENDED FOR USE AS AN AID ONLY AFTER THE PHYSICIAN HAS PERFORMED AN INITIAL INTERPRETATION OF THE RADIOGRAPH.
P000043||Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|||N|10/16/2000|06/29/2001|01M-0296|07/16/2001|APPR|APPROVAL FOR THE TMX-2000(TM) BPH THERMOTHERAPY SYSTEM.  THE DEVICE IS INDICATED AS A NON-SURGICAL DEVICE FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH OF 30 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC.
P000044||Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR|LOM|MI|||N|11/01/2000|04/27/2001|01M-0226|05/14/2001|APPR|APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNODIAGNOSTIC PRODUCTS CALIBRATOR.  THE VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM.  ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B.  IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD.  THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS IMMUNODIAGNOSTIC SYSTEM FOR THE QUALITATIVE IN VITRO DETERMINATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) USING VITROS HBSAG REAGENT PACKS.  THE VITROS HBSAG CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK.  REFER TO THE VITROS HBSAG REAGENT PACK INSTRUCTIONS FOR USE FOR FURTHER DETAILS.  THE VTIROS HBSAG CONFIRMATORY KIT IS INDICATED FOR THE QUALITATIVE CONFIRMATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) SPECIMENS THAT HAVE BEEN FOUND TO BE REPEATEDLY REACTIVE USING THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR.  THE VITROS HBSAG CONFIRMATORY KIT IS FOR USE WITH THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM.
P000046||Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II|LZP|OP|||N|11/06/2000|04/18/2001|01M-0227|05/14/2001|APPR|APPROVAL FOR REFERENCE RIGHTS TO P810025, AND FOR STAAR SURGICAL COMPANY TO DISTRIBUTE THE SODIUM HYALURONATE UNDER THE TRADENAME STAARVISC(TM) II.  THE DEVICE IS INDICATED FOR USE DURING SURGERY IN THE ANTERIOR AND POSTERIOR SEGMENTS OF THE HUMAN EYE.  PROCEDURES INCLUDE: CATARACT EXTRACTION, INTRAOCULAR LENS (IOL) IMPLANTATION, CORNEAL TRANSPLANTATION SURGERY, GLAUCOMA FILTERING SURGERY AND SURGICAL PROCEDURES TO REATTACH THE RETINA.  STAARVISC9TM) II IS DESIGNED TO CREATE AND MAINTAIN ANTERIOR CHAMBER DEPTH AND VISIBILITY, PROTECT CORNEAL ENDOTHELIAL CELLS AND OTHER INTRAOCULAR TISSUES, MINIMIZE INTERATION BETWEEN TISSUES DURING SURGICAL MANIPULATION, AND ACT AS A VITREOUS SUBSTITUTE DURING RETINAL REATTACHMENT SURGERY.  STAARVISC(TM) II ALSO PRESERVES TISSUE INTEGRITY AND GOOD VISIBILITY WHEN USED TO FILL THE ANTERIOR AND POSTERIOR SEGMENTS OF THE EYE FOLLOWING OPEN SKY PROCEDURES.
P000048||Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Generator, shock-wave, for pain relief|DORNIER EPOS ULTRA|NBN|SU|||N|11/21/2000|01/15/2002|02M-0034|01/25/2002|APPR|APPROVAL FOR THE DORNIER EPOS ULTRA.  THE DORNIER EPOS ULTRA IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC PLANTAR FASCIITIS FOR PATIENTS WITH SYMPTOMS OF PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY.  PLANTAR FASCIITIS IS DEFINED AS THE TRACTION DEGENERATION OF THE PLANTAR FASCIAL BAND AT ITS ORIGIN ON THE MEDICAL TUBERCLE OF THE CALCANEUS.
P000049||NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD|MLV|CV|||N|11/21/2000|12/05/2001|02M-0272|06/27/2002|APPR|APPROVAL FOR THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD.  THE SYSTEM IS INDICATED FOR USE IN PATIENTS WITH COMPLEX VENTRICULAR SEPTAL DEFECTS (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE WHO ARE CONSIDERED TO BE AT HIGH RISK FOR STANDARD TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE BASED ON ANATOMICAL CONDITIONS AND/OR BASED ON OVERALL MEDICAL CONDITION.  HIGH RISK ANATOMICAL FACTORS FOR TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE INCLUDE PATIENTS:  1) REQUIRING A LEFT VENTRICULOTOMY OR AN EXTENSIVE RIGHT VENTRICULOTOMY;  2) WITH A FAILED PREVIOUS VSD CLOSURE;  3) WITH MULTIPLE APICAL AND/OR ANTERIOR MUSCULAR VSDS ("SWISS CHEESE SEPTUM"); OR  4) WITH POSTERIOR APICAL VSDS COVERED BY TRABECULAE.
P000052||GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|||N|12/18/2000|11/02/2001|01M-0508|11/14/2001|APWD|APPROVAL FOR THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, 27 MM GALILEO CENTERING CATHETER, AND 27 MM 32P SOURCE WIRE.  THE DEVICE IS INDICATED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS <= 47 MM IN REFERENCE VESSEL DIAMETER 2.4 MM TO 3.7 MM.
P000053||Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS SPHINCTER 800 URINARY CONTROL SYSTEM|EZY|GU|||N|12/19/2000|06/14/2001|01M-0579|12/21/2001|APPR|APPROVAL FOR THE AMS SPHINCTER 800(TM) URINARY PROSTHESIS.  THE DEVICE IS USED TO TREAT URINARY INCONTINENCE DUE TO REDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY.
P000054||Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|||N|12/20/2000|04/30/2004|04M-0249|05/26/2004|APPR|APPROVAL FOR THE INFUSE BONE GRAFT.  THE DEVICE IS INDICATED FOR TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT.  INFUSE BONE GRAFT MUST BE APPLIED WITHIN 14 DAYS AFTER THE INITIAL FRACTURE.  PROSPECTIVE PATIENTS SHOULD BE SKELETALLY MATURE.
P000055||DIAGNOSTIC MEDICAL SYSTEMS|DISTRICT DE MONTPELLIER,||PEROLS||34470||Bone sonometer|UBIS 5000 BONE SONOMETER|MUA|RA|||N|12/18/2000|07/17/2001|01M-0360|08/23/2001|APRL|APPROVAL FOR THE UBIS 5000.  THE UBIS 5000 IS A QUANTITATIVE ULTRASOUND (AUS) BONE SONOMETER AND IS INDICATED FOR THE MEASUREMENT OF BROADBAND ULTRASOUND ATTENUATION (BUA) OF THE CALCANEUS, AS AN AID TO DIAGNOSE OSTEOPOROSIS AND TO ESTIMATE THE RISK OF SUBSEQUENT ATRAUMATIC FRACTURE.  THE OUTPUT IS EXPRESSED IN TERMS OF BOTH BUA AND T-SCORE.
P000057||INTEGRA LIFESCIENCES CORPORATION|8900 CAMERON ROAD||AUSTIN|TX|78754||Finger semi-constrained pyrolytic carbon uncemented prosthesis|ASCENSION MCP|NEG|OR|||Y|12/29/2000|11/19/2001|01M-0530|11/29/2001|APPR|THIS DEVICE IS INDICATED FOR USE AS A TOTAL JOINT REPLACEMENT OF INDEX, LONG, RING, AND SMALL FINGER METACARPOPHALANGEAL JOINTS THAT EXHIBIT SYMPTOMS OF PAIN, LIMITED MOTION, OR INADEQUATE BONY ALIGNMENT (I.E., SUBLUXATION/DISLOCATION) SECONDRY TO ARTICULAR DESTRUCTION OR DEGENERATIVE DISEASE RELATED TO RHEUMATOID ARTHRITIS, LUPUS ERYTHEMATOSUS, OSTEOARTHRITIS, OR POST TRAUMATIC ARTHRITIS WHERE SOFT TISSUE RECONSTRUCTION CAN PROVIDE ADEQUATE STABILIZATION.
P000058||Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|||Y|12/22/2000|07/02/2002|02M-0310|07/11/2002|APPR|APPROVAL FOR THE INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE.  THIS DEVICE IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, FUNCTION DEFICIT AND/OR NEUROLOGICAL DEFICIT AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL.  INFUSE BONE GRAFT/LT-CAGE DEVICES ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN OR AN ANTERIOR LAPAROSCOPIC APPROACH.  PATIENTS RECEIVING THE INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/LT-CAGE DEVICE.
P010001||CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|||N|01/31/2001|02/03/2003|03M-0332|07/30/2003|APPR|APPROVAL FOR THE CERAMIC TRANSCEND HIP ARTICULATION SYSTEM.  THE DEVICE IS INDICATED FOR PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.
P010002||COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES|150 GLOVER AVE.||NORWALK|CT|06856||Tissue adhesive for the topical approximation of skin|INDERMIL(TM) TISSUE ADHESIVE|MPN|SU|||N|02/01/2001|05/22/2002|03M-0040|02/05/2003|APRL|APPROVAL FOR THE INDERMIL TISSUE ADHESIVE.  THE DEVICE IS INDICATED FOR THE CLOSURE OF TOPICAL SKIN INCISIONS INCLUDING LAPAROSCOPIC INCISIONS, AND TRAUMA-INDUCED LACERATIONS IN AREAS OF LOW SKIN TENSION THAT ARE SIMPLE, THOROUGHLY-CLEANSED, AND HAVE EASILY APPROXIMATED SKIN EDGES.  INDERMIL MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.
P010003||CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|||N|02/02/2001|12/03/2001|01M-0567|12/20/2001|APPR|APPROVAL FOR THE BIOFLUE SURGICAL ADHESIVE.  THIS DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO STANDARD METHODS OF ACHIEVING HEMOSTASIS (SUCH AS SUTURES AND STAPLES) IN ADULT PATIENTS IN OPEN SURGICAL REPAIR OF LARGE VESSELS (SUCH AS AORTA, FEMORAL AND CAROTID ARTERIES).
P010007||SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP|LOK|IM|||N|02/13/2001|11/09/2001|01M-0537|12/05/2001|APPR|APPROVAL FOR IMMULITE AFP FOR USE WITH THE IMMULITE ANALYZER  AND IMMULITE 2000 AFP FOR USE WITH THE IMMULITE 2000 ANALYZER.  THESE DEVICES ARE INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE QUANTITATIVE MEASUREMENT OF ALPHA-FETOPROTEIN (AFP) IN EITHER OF TWO CONTEXTS:  A)  SERIAL MEASUREMENTS IN HUMAN SERUM TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER: OR  B) MEASUREMENT IN MATERNAL SERUM AND AMNIOTIC FLUID DURING GESTATIONAL WEEKS 15 THROUGH 20 - USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY - TO AID IN DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS.
P010012||Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL|NIK|CV|||Y|02/27/2001|05/02/2002|02M-0236|05/22/2002|APPR|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
P010013||HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|||N|02/28/2001|09/28/2001|02M-0128|03/28/2002|APPR|APPROVAL FOR THE NOVASURE(TM) IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM.  THE DEVICE IS INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS OF PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
P010014||BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|||N|03/01/2001|04/21/2004|04M-0200|05/05/2004|APPR|APPROVAL FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (PHASE 3).  THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND INTENDED TO BE IMPLANTED WITH BONE CEMENT.
P010015||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM|LWP|CV|||Y|03/02/2001|08/28/2001|01M-0373|08/30/2001|APPR|APPROVAL FOR THE MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM INCLUDING THE MODEL 8040 INSYNC PULSE GENERATOR, THE MODEL 9980 PROGRAMMER SOFTWARE, AND THE ATTAIN LV MODEL 2187 AND ATTAIN CS MODEL 2188 LEADS.  THE PULSE GENERATOR AND LEADS ARE INDICATED AS FOLLOWS:  1) THE INSYNC MODEL 8040 PULSE GENERATOR IS INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SECERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL, MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A QRS DURATION = 130 MS.  2) THE ATTAIN LV MODEL 2187 LEAD HAS APPLICATION AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.  3) THE ATTAIN CS MODEL 2188 LEAD HAS APPLICATION WHERE PERMANENT ATRIAL, OR FUAL-CHAMBER PACING SYSTEMS ARE INDICATED, OR AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.
P010016||FORTICELL BIOSCIENCE|3960 BROADWAY||NEW YORK|NY|10032||Dressing, wound and burn, interactive|ORCEL BILAYERED CELLULAR MATRIX|MGR|SU|||N|03/05/2001|08/31/2001|01M-0413|09/20/2001|APPR|APPROVAL FOR THE ORCE BILAYERED CELLULAR MATRIX.  THE DEVICE IS INDICATED FOR THE TREATMENT OF FRESH, CLEAN SPLIT THICKNESS DONOR SITE WOUNDS IN BURN PATIENTS.
P010017||HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Full field digital,system,x-ray,mammographic|SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|||N|03/13/2001|09/25/2001|01M-0509||APRL|APPROVAL FOR THE SENOSCAN(R) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.  THE DEVICE IS A DEDICATED MAMMOGRAPHY SYSTEM INTENDED TO PRODUCE RADIOGRAPHIC IMAGES OF THE HUMAN BREAST FOR THE PURPOSE OF DIAGNOSTIC AND SCREENING MAMMOGRAPHY.  THE SENOSCAN(R) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED TO BE USED IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHY SYSTEMS.
P010018||REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT(TM) CK SYSTEM|MWD|OP|||N|03/14/2001|04/11/2002|02M-0174|04/25/2002|APPR|APPROVAL FOR THE REFRACTEC VIEWPOINT CK SYSTEM.  THIS DEVICE IS INDICATED FOR:  TEMPORARY REDUCTION OF SPHERICAL HYPEROPIA IN PATIENTS WHO HAVE 0.75 D TO 3.25 D OF CYCLOPLEGIC SPHERICAL HYPEROPIA, LESS THAN OR EQUAL TO 0.75 D OF REFRACTIVE ASTIGMATISM (MINUS CYLINDER FORMAT), A CYCLOPLEGIC SPHERICAL EQUIVALENT OF 0.75 D TO 3.00 D, AND ARE 40 YEARS OF AGE OR GREATER WITH A DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTH, AS DEMONSTRATED BY A CHANGE OF LESS THAN 0.50 D IN SPHERICAL AND CYLINDRICAL COMPONENTS OF THE MANIFEST REFRACTION.  THE MAGNITUDE OF CORRECTION WITH THIS TREATMENT DIMINISHES OVER TIME, WITH SOME PATIENTS RETAINING SOME OR ALL OF THEIR INTENDED REFRACTIVE CORRECTION.
P010019||Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|||N|03/21/2001|10/11/2001|01M-0479|10/19/2001|APPR|APPROVAL FOR THE FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR.  THE DEVICE WILL BE MARKETED WITH THE FOLLOWING TRADE NAMES AND INDICATIONS:  FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES AND WITH UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM.  FOCUS NIGHT AND DAY TORIC (LOTRAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH 6.00 DIOPTERS (D) OR LESS OF ASTIGMATISM.  FOCUS NIGHT AND DAY PROGRESSIVES (LOTRAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) AND/OR PRESBYOPIA IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY REQUIRE A READING ADDITION OF +3.00 DIOPTERS (D) OR LESS AND WHO MAY HAVE UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM.  THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR FOR UP TO 30 NIGHTS OF CONTINUOUS WEAR, WITH REMOVAL FOR DISPOSAL, OR CLEANING AND DISINFECTION PRIOR TO REINSERTION, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.
P010020||Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICON NEOSPHINCTER|MIP|GU|||N|03/30/2001|12/18/2001|01M-0581|12/26/2001|APPR|APPROVAL FOR THE AMS ACTICON NEOSPHINCTER SYSTEM.  THIS DEVICE IS INDICATED TO TREAT SEVERE FECAL INCONTINENCE IN MALES AND FEMALES EIGHTEEN YEARS AND OLDER WHO HAVE FAILED, OR ARE NOT CANDIDATES FOR, LESS INVASIVE FORMS OF RESTORATIVE THERAPY.
P010021||Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|||N|04/02/2001|08/30/2001|01M-0536|12/05/2001|APPR|APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR.  THESE DEVICES ARE INDICATED FOR: THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM.  THREE RECOMBINANT HEPATITIS C VIRUS ENCODED ANTIGENS ARE USED.  ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HEPATITIS C VIRUS (STATE OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING VITROS ANTI-HCV REAGENT PACKS.  THE VITROS ANTI-HCV CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK.
P010022||ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Sealant,polymerizing|COSEAL SURGICAL SEALANT (COSEAL)|NBE|CV|||N|04/12/2001|12/14/2001|02M-0076|02/25/2002|APWD|APPROVAL FOR THE COSEAL SURGICAL SEALANT.  THIS DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
P010023||OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|SOUNDTEC DIRECT SYSTEM|MPV|EN|||N|04/13/2001|09/07/2001|01M-0414|09/20/2001|APPR|APPROVAL FOR THE SOUNDTEC(R) DIRECT SYSTEM.  THIS DEVICE IS INDICATED FOR USE IN ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS AND DESIRE AN ALTERNATIVE TO AN ACOUSTIC HEARING AID.  PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
P010025||HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|LORAD DIGITAL BREAST IMAGER|MUE|RA|||N|04/30/2001|03/15/2002|02M-0173|04/25/2002|APRL|APPROVAL FOR THE LORAD DIGITAL BREAST IMAGER.  THE DEVICE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER.  IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM MAMMOGRAPHIC SYSTEMS.
P010027||AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)|HQL|OP|||N|04/30/2001|11/21/2001|02M-0180|05/07/2002|APWD|APPROVAL FOR THE ALLERGAN, INC. MODEL AC21B ULTRAVIOLET-ABSORBING PMMA ANTERIOR CHAMBER INTRAOCULAR LENS, AVAILABLE IN THREE OVERALL DIAMETERS (12.0 MM, 13.0 MM, 14.0 MM).  THE APPLICATION IS A LICENSING PMA IN WHICH ALLERGAN, INC. HAS GIVING OPHTHALMIC INNOVATIONS INTERNATIONAL, INC. REFERENCE RIGHTS TO P860034.  ADDITIONALLY, IT IS REQUESTED THAT ALLERGAN, INC. DISTRIBUTE THE LENS AS THE DURALENS II MODEL AC21B.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS IN THE VISUAL CORRECTION OF APHAKIA.  THE ANTERIOR CHAMBER INTRAOCULAR LENS IS TO BE USED IN PATIENTS 60 YEARS OF AGE AND OLDER WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY PRIMARY INTRACAPSULAR CATARACT EXTRACTION (ICCE); OR BY PRIMARY EXTRACAPSULAR CATARACT EXTRACTION (ECCE) WHERE THERE IS A STRUCTURAL REASON THAT THE ANTERIOR CHAMBER LENS IS THE PREFERRED ONE; OR OTHER PRIMARY ECCE PROVIDED THAT THIS BE PERFORMED ONLY AFTER THE PHYSICIAN HAS COMPARED THE PUBLISHED RESULTS OF THE ANTERIOR CHAMBER LENS WITH POSTERIOR CHAMBER LENSES; OR IN A SECONDARY IMPLANT PROCEDURE.
P010029||FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|||N|05/01/2001|12/03/2004|06M-0338|08/24/2006|APPR|APPROVAL FOR NUFLEXXA (1% SODIUM HYALURONATE).  THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
P010030||ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST|MVK|CV|||N|05/04/2001|12/18/2001|02M-0145|04/12/2002|APPR|APPROVAL FOR THE WCD 2000 SYSTEM.  THIS DEVICE IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND EITHER ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P010031||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|||Y|05/04/2001|06/26/2002|02M-0381|08/26/2002|APPR|APPROVAL FOR THE INSYNC ICD MODEL 7272 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY AND THE MODEL 9969 APPLICATION SOFTWARE.  THE INSYNC ICD MODEL 7272 IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A QRS DURATION GREATER THAN OR EQUAL TO 130 MS.
P010032||St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|||N|05/29/2001|11/21/2001|01M-0534|12/03/2001|APPR|APPROVAL FOR THE GENESIS NEUROSTIMULATION (IPG) SYSTEM.  THE SYSTEM INCLUDES THE FOLLOWING COMPONENTS: THE MODEL 3608 PULSE GENERATOR, THE MODEL 3850 PATIENT PROGRAMMER, THE MODEL 1232 PROGRAMMING WAND AND THE MODEL 1210 PATIENT MAGNET.  THE DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P010033||QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE|NCD|MI|||Y|06/01/2001|11/28/2001|02M-0218|05/13/2002|APPR|APPROVAL FOR THE CELLESTIS QUANTIFERON-TB.  THE DEVICE IS INDICATED FOR USE AS AN AID IN THE DETECTION OF INFECTION WITH MYCOBACTERIUM TUBERCULOSIS.
P010034||ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK (TM)|MYN|RA|||N|06/11/2001|01/31/2002|01M-0060|02/07/2002|APWD|APPROVAL FOR THE SECOND LOOK.   COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P010038||ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK|MYN|RA|||N|07/19/2001|01/15/2002|02M-0030|01/22/2002|APPR|APPROVAL FOR THE MAMMOREADER.  THE MAMMOREADER IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P010039||SIEMENS MEDICAL SOLUTIONS USA, INC.|51 VALLEY STREAM PKWY.||MALVERN|PA|19355|1406|Generator, shock-wave, for pain relief|SIEMENS SONOCUR BASIC SYSTEM|NBN|SU|||N|07/27/2001|07/19/2002|01M-0336|08/06/2002|APWD|APPROVAL FOR THE SIEMENS SONOCUR BASIC.  THE SIEMENS SONOCUR BASIC IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC LATERAL EPICONDYLITIS (COMMONLY REFERRED TO AS TENNIS ELBOW) FOR PATIENTS WITH SYMPTOMS OF CHRONIC LATERAL EPICONDYLITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE TREATMENTS.
P010040||RedHawk Medical Products & Services LLC|P.O. Box 53929||Lafayette|LA|70505|3929|Device, needle destruction|THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE|MTV|HO|||N|08/01/2001|03/15/2002|02M-0118|03/22/2002|APPR|APPROVAL FOR THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE.  THE DEVICE IS INDICATED FOR INSULIN NEEDLE DESTRUCTION FOR HOME USE.
P010041||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)|DYE|CV|||N|08/01/2001|06/24/2002|03M-0086|03/07/2003|APPR|APPROVAL FOR THE CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC), WHICH INCLUDES SIZES 21, 23, 25 AND 27MM.  THIS DEVICE IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC AORTIC VALVE.
P010043||YAMA, INC.|P.O. BOX 884||MILLBURN|NJ|07041||CAP, CERVICAL, CONTRACEPTIVE|LEA'S SHIELD BARRIER CONTRACEPTIVE|LLQ|OB|||N|08/13/2001|03/14/2002|02M-0471|10/30/2002|APPR|APPROVAL FOR THE LEA'S SHIELD BARRIER CONTRACEPTIVE.  THE DEVICE IS INDICATED FOR USE BY WOMEN OF CHILDBEARING AGE WHO DESIRE TO PREVENT OR POSTPONE PREGNANCY.
P010047||NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|||N|08/23/2001|01/14/2010|10M-0068|01/27/2010|APPR|APPROVAL FOR PROGEL PLEURAL AIR LEAK SEALANT.  THE DEVICE IS INDICATED FOR APPLICATION TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE WITH, FOR EXAMPLE, SUTURES OR STAPLES, OF VISIBLE AIR LEAKS (>=2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA.
P010049||SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM|MGB|CV|||N|09/10/2001|03/25/2002|02M-0134|03/29/2002|APPR|APPROVAL FOR THE QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM.  THE DEVICE IS INDICATED FOR THE DELIVERY OF GELFOAM FOR THE EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITE.  THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS.  THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND REDUCES TIME TO ACTUAL HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES.
P010050||Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE 2000 XPI HBSAG|LOM|MI|||N|08/31/2001|07/26/2002|03M-0262|06/24/2003|APPR|APPROVAL FOR THE IMMULITE HBSAG, IMMULITE 2000 HBSAG AND IMMULITE HBSAG CONFIRMATORY KIT.  THESE DEVICES ARE INDICATED FOR:  IMMULITE HBSAG:  IMMULITE HBSAG IS A SOLID-PHASED CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR IN VITRO USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE).  IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS B VIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.  IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD.  IMMULITE. 2000 HBSAG: IMMULITE 2000 HBSAG IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR IN VITRO USE WITH THE IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE).  IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS B VIRUS INFECTIONS IN CONJUNCTION  WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.  IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD.  IMMULITE HBSAG CONFIRMATORY KIT:  IMMULITE HBSAG CONFIRMATORY IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN CONJUNCTION WITH THE IMMULITE HBSAG OR THE IMMULITE 2000 HBSAG ASSAYS FOR THE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE) THAT WERE REPEATEDLY POSITIVE WHEN TESTED BY IMMULITE OR IMMULITE 2000 HBSAG.
P010051||Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE 2000 XPI ANTI-HBC|LOM|MI|||N|08/31/2001|07/24/2002|03M-0271|06/24/2003|APPR|APPROVAL FOR THE IMMULITE ANTI-HBC AND IMMULITE 2000 ANTI-HBC.  THESE DEVICES ARE INDICATED FOR:  IMMULITE. ANTI-HBC: IMMULITE ANTI-HBC IS A SOLID -PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE ON THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES AGAINST HEPATITIS  B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE).  IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ONGOING OR PREVIOUS HEPATITIS B VIRUS INFECTION.  IMMULITE. 2000 ANTI-HBC: IMMULITE 2000 ANTI-HBC IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE ON THE IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES AGAINST HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE).  IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ONGOING OR PREVIOUS HEPATITIS B VIRUS INFECTION .
P010052||Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE 2000 XPI ANTI-HBS|LOM|MI|||N|08/31/2001|07/22/2002|03M-0287|06/24/2003|APPR|APPROVAL FOR THE IMMULITE ANTI-HBS AND IMMULITE 2000 ANTI-HBS.  THE DEVICES ARE INDICATED FOR:  IMMULITE ANTI-HBS:  FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED OR EDTA).  ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.  THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.  IMMULITE 2000 ANTI-HBS:  FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED OR EDTA).  ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.  THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.
P010053||Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE 2000 XPI ANTI-HBC IMG|LOM|MI|||N|08/31/2001|07/26/2002|03M-0272|06/24/2003|APPR|APPROVAL FOR THE IMMULITE ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBC IGM.  THESE DEVICES ARE INDICATED FOR:  IMMULITE. ANTI-HBC IGM: IMMULITE ANTI-HBC IGM IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM AND PLASMA (EDTA, HEPARINIZED OR CITRATE).  IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE OR RECENT (USUALLY WITHIN 6 MONTHS) HEPATITIS B VIRAL INFECTION.  IMMULITE. 2000 ANTI-HBC IGM: IMMULITE 2000 ANTI-HBC IGM IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE WITH THE IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT IF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM AND PLASMA (EDTA, HEPARINIZED OR CITRATE).  IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE OR RECENT (USUALLY WITHIN 6 MONTHS) HEPATITIS B VIRAL INFECTION.
P010054||ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS|LOM|MI|||N|09/10/2001|02/28/2002|02M-0179|04/25/2002|APPR|APPROVAL FOR THE ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS.  THE ELECSYS ANTI-HBS IMMUNOASSAY IS INDICATED FOR:  THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (EDTA).  THE ELECTROCHEMILUMIN-ESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 IMMUNOASSAY ANALYZER.  ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.  THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.  THE ELECSYS PRECICONTROL ANTI-HBS IS INDICATED FOR:  THE PRECICONTROL ANTI-HBS IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER.  THE PERFORMANCE OF THE PRECICONTROL ANTI-HBS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.
P010055||PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH|MEQ|GU|||N|09/10/2001|12/23/2002|03M-0189|05/09/2003|APPR|APPROVAL FOR THE PROSTALUND CORETHERM MICROWAVE THERMOTHERAPY SYSTEM.  THE PROSTALUND CORETHERM IS A NON-SURGICAL, MINIMALLY INVASIVE DEVICE INTENDED TO RELIEVE SYMPTOMS ASSOCIATED WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) BYE PROSTALUND FEEDBACK TREATMENT (PLFT), AND IS INDICATED FOR MEN WITH PROSTATE SIZE OF 30 TO 100G AND PROSTATIC URETHRA LENGTH >= 35 MM.
P010058||MEDILINK|80, RUE DE L'HORTUS||CARNON||F3428||Bone sonometer|OSTEOSPACE|MUA|RA|||N|10/03/2001|03/15/2004|05M-0024|01/21/2005|APRL|APPROVAL FOR THE OSTEOSPACE.  THE OSTEOSPACE IS A QUANTITATIVE ULTRASOUND BONE SONOMETER DEVICE (QUS) TO BE USED FOR THE MEASUREMENT OF BROADBAND ULTRASOUND ATTENUATION (BUA) OF THE CALCANEUS, AS AN AID, TOGETHER WITH OTHER CLINICAL RISK FACTORS, TO DIAGNOSE OSTEOPOROSIS AND OTHER MEDICAL CONDITIONS LEADING TO REDUCED BONE STRENGTH AND TO ESTIMATE THE RISK OF SUBSEQUENT ATRAUMATIC FRACTURE.  THE OUTPUT IS EXPRESSED IN TERMS OF BUA, T-SCORE, AND Z-SCORE.
P010059||MORCHER GMBH|KAPUZINERWEG 12||STUTTGART, WURTTEMBERG-BADEN||D-703|7037|Ring, endocapsular|MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C|MRJ|OP|||Y|10/16/2001|10/23/2003|04M-0022|01/21/2004|APPR|APPROVAL FOR THE MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C.  THE DEVICE IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK OR PARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION.  CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARY ZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA OR VITRECTOMY) CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI'S SYNDROME.
P010061||PHOTO CURE ASA|HOFFSVEIEN 48||OSLO||N-037|0377|SYSTEM,NON-COHERENT LIGHT,PHOTODYNAMIC THERAPY|CURELIGHT BROADBAND (MODEL CURELIGHT 01)|MYH|SU|||N|09/27/2001|07/28/2004|04M-0345|08/04/2004|APWD|APPROVAL FOR THE CURELIGHT BROADBAND (MODEL CURELIGHT 01).  THE DEVICE IS INDICATED FOR USE IN COMBINATION WITH TRADENAME CREAM FOR TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF THE FACE AND SCALP IN IMMUNOCOMPETENT PATIENTS WHEN USED IN CONJUNCTION WITH LESION PREPARATION (DEBRIDEMENT USING A SHARP DERMAL CURETTE) IN THE PHYSICIAN'S OFFICE WHEN OTHER THERAPIES ARE UNACCEPTABLE OR CONSIDERED MEDICALLY LESS APPROPRIATE.
P010062||BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR|NUU|OP|||N|10/26/2001|06/07/2004|04M-0260|06/14/2004|APPR|APPROVAL FOR THE EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR.  THE LENSES ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES.  THE LENSES ARE INDICATED FOR OVERNIGHT WEAR FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.50 DIOPTERS.  THE LENSES MAY ONLY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM.  NOTE: TO MAINTAIN THE ORTHOKERATOLOGY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE.  FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.
P010065||E MED FUTURE|354 S. CLAY STREET||MILLERSBURG|OH|44654||Device, needle destruction|NEEDLE ZAP (R)|MTV|HO|||N|12/18/2001|03/14/2003|03M-0115|03/25/2003|APPR|APPROVAL FOR THE NEEDLEZAP.  THE DEVICE IS A PORTABLE NEEDLE DESTRUCTION DEVICE THAT IS INDICATED FOR USE BY HEALTH CARE PROFESSIONALS TO DESTROY PREVIOUSLY USED ALUMINUM AND STAINLESS STEEL NEEDLES (GAUGES 16 - 30,3/4- 2 INCHES IN LENGTH) ATTACHED TO SYRINGES.  THE NEEDLEZAP PRODUCT IS INTENDED FOR USE IN HEALTH CARE FACILITIES AND TREATMENT SETTINGS.
P010068||BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER|OAD|CV|||N|12/31/2001|09/27/2002|03M-0049|02/10/2003|APPR|APPROVAL FOR THE NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS, STOCKERT 70 GENERATOR AND ACCESSORIES.  THE NAVISTAR DS AND CELSIUS DS CATHETERS AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING), AND FOR USE WITH THE STOCKERT 70 (MODEL S7001 WITH SOFTWARE VERSION 001/033) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.  THE NAVISTAR DS CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO EP NAVIGATION SYSTEM.
P020001||NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|STAN S31 FETAL HEART MONITOR|HEO|OB|||N|01/02/2002|11/01/2005|06M-0009|01/09/2006|APPR|APPROVAL FOR THE STAN S31 FETAL HEART MONITOR.  THE DEVICE IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.  THE DEVICE IS INTENDED FOR USE IN PATIENTS WITH: 1) PLANNED VAGINAL DELIVERY; 2) >36 COMPLETED WEEKS GESTATION; 3) SINGLETON FETUS; 4) VERTEX PRESENTATION; AND 5) RUPTURED AMNIOTIC MEMBRANES.
P020002||HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP (R) IMAGING SYSTEM|MNM|PA|||N|01/07/2002|06/06/2003|03M-0339|07/30/2003|APPR|APPROVAL FOR THE THINPREP IMAGING SYSTEM.  THE DEVICE IS INDICATED FOR ASSISTING IN PRIMARY CERVICAL CANCER SCREENING OF THINPREP PAP TEST SLIDES FOR THE PRESENCE OF ATYPICAL CELLS, CERVICAL NEOPLASIA, INCLUDING ITS PRECURSOR LESIONS (LOW GRADE SQUAMOUS INTRAEPITHELIAL LESIONS, HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESIONS, AND CARCINOMA AS WELL AS ALL OTHER CYTOLOGICAL CRITERIA AS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY.
P020003||COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Prosthesis, testicular|COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS|FAF|GU|||Y|01/22/2002|07/19/2002|02M-0322|08/06/2002|APPR|APPROVAL FOR THE MENTOR SALINE-FILLED TESTICULAR PROSTHESIS.  THE DEVICE IS INDICATED FOR USE WHEN COSMETIC TESTICULAR REPLACEMENT IS INDICATED; I.E., IN THE CASE OF AGENESIS OR FOLLOWING THE SURGICAL REMOVAL OF A TESTICLE.
P020004||W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|||N|01/23/2002|11/06/2002|02M-0527|12/20/2002|APPR|APPROVAL FOR THE EXCLUDER BIFURCATED ENDOPROSTHESIS.  THE EXCLUDER BIFURCATED ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY AS DESCRIBED:  1) ADEQUATE ILIAC/FEMORAL ACCESS  2) INFRARENAL AORTIC NECK TREATMENT DIAMETER RANGE OF 19-26 MM AND A MINIMUM AORTIC NECK LENGTH OF 15 MM  3) PROXIMAL AORTIC NECK ANGULATION <= 60 DEGREES  4) ILIAC ARTERY TREATMENT DIAMETER RANGE OF 8-13.5 MM AND ILIAC DISTAL VESSEL SEAL ZONE LENGTH OF AT LEAST 10 MM.  THE AORTIC AND ILIAC EXTENDER ENDOPROSTHESES ARE INTENDED TO BE USED AFTER DEPLOYMENT OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS.  THESE EXTENSIONS ARE INTENDED TO BE USED WHEN ADDITIONAL LENGTH AND/OR SEALING FOR ANEURISMAL EXCLUSION IS DESIRED.
P020006||Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MAILSTOP: MB-16|MARLBOROUGH|MA|01752||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|ENTERYX PROCEDURE KIT|LNM|GU|||N|02/11/2002|04/22/2003|04M-0145|04/01/2004|APWD|APPROVAL FOR THE ENTERYX PROCEDURE KIT.  THE DEVICE IS INDICATED FOR ENDOSCOPIC INJECTION INTO THE REGION OF THE LOWER ESOPHAGEAL SPHINCTER (LES) FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS IN PATIENTS RESPONDING TO AND REQUIRING DAILY PHARMACOLOGICAL THERAPY WITH PROTON PUMP INHIBITORS.
P020007||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, RENAL|MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM|NIN|CV|||Y|02/15/2002|12/18/2002|03M-0487|10/28/2003|APWD|APPROVAL FOR THE MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE (OTW) RENAL STENT SYSTEM.  THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUB-OPTIMAL OR FAILED PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A DE NOVO LESION (<=15 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE AORTORENAL BORDER AND WITH A REFERENCE VESSEL DIAMETER OF 5.0 TO 7.0 MM.  SUB-OPTIMAL OR FAILED PTRA INCLUDE ANY OF THE FOLLOWING:  VISIBLE EVIDENCE OF A RESIDUAL STENOSIS >=50% AFTER OPTIMAL PTRA, VISIBLE EVIDENCE OF INTIMAL DISSECTION >6 MM, OR PEAK SYSTOLIC TRANS-STENOTIC GRADIENT OF >=20 MM HG OR A MEAN OF >=10 MM HG.
P020008||KARL STORZ ENDOSCOPY-AMERICA, INC.|600 CORPORATE POINTE||CULVER CITY|CA|90230|7600|SYSTEM, IMAGING, FLUORESCENCE|KARL STORZ AUTOFLUORESCENCE SYSTEM|MRK|EN|||N|03/07/2002|12/12/2002|03M-0011|01/22/2003|APPR|APPROVAL FOR THE KARL STORZ AUTOFLUORESCENCE SYSTEM.  THE KARL STORZ AUTOFLUORESCENCE SYSTEM IS INDICATED FOR USE IN WHITE LIGHT AND AUTOFLUORESCENCE BRONCHOSCOPY TO IDENTIFY AND LOCATE ABNORMAL BRONCHIAL TISSUE FOR BIOPSY AND HISTOLOGICAL EVALUATION.  IT IS INDICATED IN PATIENTS WHO:  1) ARE SUSPECTED OF HAVING BRONCHOGENIC CARCINOMA AND ARE SCHEDULED FOR A BRONCHOSCOPY AS PART OF A STANDARD DIAGNOSTIC STAGING OR WORK-UP  2) HAVE BEEN PREVIOUSLY DIAGNOSED WITH LUNG CANCER AND WHO ARE AT HIGH RISK FOR RECURRENCE  3) HAVE ABNORMAL SPUTUM CYTOLOGY  4) HAVE ABNORMAL CHEST X-RAY, CT SCAN OR SIMILAR TECHNOLOGY.
P020009||BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS|MAF|CV|||N|03/15/2002|09/11/2002|03M-0116|03/25/2003|APPR|APPROVAL FOR THE EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS.  THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE ASSOCIATED WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH < 18 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 5.0 MM.  2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE (AC/TAC) IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS IN NATIVE CORONARY ARTERIES OF 2.25 TO 5.0 MM (INCLUSIVE) IN DIAMETER AND < 30 MM LONG.  LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P020011||GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA QUALITATIVE ASSAY|MZP|MI|||N|03/18/2002|11/07/2002|03M-0070|02/28/2003|APPR|APPROVAL FOR THE VERSANT HCV RNA QUALITATIVE ASSAY.  THE DEVICE IS INDICATED FOR:  THE VERSANT HCV RNA QUALITATIVE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION ASSAY FOR THE DETECTION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA (EDTA, SODIUM HEPARIN, SODIUM CITRATE, AND ACD) OR SERUM.  THE VERSANT HCV RNA QUALITATIVE  ASSAY IS INDICATED FOR USE WITH FRESH OR FROZEN SPECIMENS FROM THE FOLLOWING POPULATIONS: INDIVIDUALS WITH ANTIBODY EVIDENCE OF HCV INFECTION WITH EVIDENCE OF LIVER DISEASE, AND INDIVIDUALS SUSPECTED TO BE ACTIVELY INFECTED WITH HCV WITH ANTIBODY EVIDENCE, AND INDIVIDUALS AT RISK FOR HCV INFECTION WITH ANTIBODIES TO HCV.  DETECTION OF HCV RNA IS EVIDENCE OF ACTIVE HCV INFECTION.
P020012||SUNEVA MEDICAL, INC.|5879 PACIFIC CENTER BLVD.||SAN DIEGO|CA|92121||Implant, dermal, for aesthetic use|ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER|LMH|SU|||N|04/01/2002|10/27/2006|06M-0455|11/08/2006|APPR|APPROVAL FOR THE ARTEFILL, WHICH IS INDICATED FOR CORRECTION OF NASOLABIAL FOLDS.
P020014||BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|||Y|04/22/2002|11/04/2002|03M-0175|04/28/2003|APPR|APPROVAL FOR THE ESSURE SYSTEM.  THE DEVICE IS INDICATED FOR PERMANENT BIRTH CONTROL (FEMALE STERILIZATION) BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES.
P020016||BIOMET MICROFIXATION, INC.|1520 TRADEPORT DR.||JACKSONVILLE|FL|32218||Joint, temporomandibular, implant|WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM|LZD|DE|||N|05/13/2002|09/21/2005|05M-0399|10/05/2005|APPR|APPROVAL FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.  THE DEVICE IS INDICATED FOR RECONSTRUCTION OF THE TEMPOROMANDIBULAR JOINT.  THE RECONSTRUCTION IS NECESSARY DUE TO ONE OF THE FOLLOWING DIAGNOSES: 1) ARTHRITIC CONDITIONS: OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, 2) ANKYLOSIS INCLUDING BUT NOT LIMITED TO RECURRENT ANKYLOSIS WITH EXCESSIVE HETEROTOPIC BONE FORMATION, 3) REVISION PROCEDURES WHERE OTHER TREATMENTS HAVE FAILED (E.G. ALLOPLASTIC RECONSTRUCTION, AUTOGENOUS GRAFTS), 4) AVASCULAR NECROSIS, 5) MULTIPLY OPERATED JOINTS, 6) FRACTURE, 7) FUNCTIONAL DEFORMITY, 8) BENIGN NEOPLASMS, 9) MALIGNANCY (E.G. POST-TUMOR EXCISION), 10) DEGENERATED OR RESORBED JOINTS WITH SEVERE ANATOMIC DISCREPANCIES, AND 11) DEVELOPMENTAL ABNORMALITY.
P020018||COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM|MIH|CV|||N|05/24/2002|05/23/2003|03M-0242|07/11/2003|APPR|APPROVAL FOR THE ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM.  THE DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR.
P020021||COOK ENDOSCOPY|4900 BETHANIA STATION RD.||WINSTON-SALEM|NC|27105||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER|MVG|SU|||N|05/31/2002|08/01/2003|04M-0495|11/12/2004|APWD|APPROVAL FOR THE WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER, WHICH REQUESTED APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE INDICATION FOR USE FOR ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.
P020022||SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|||Y|06/19/2002|03/28/2003|04M-0538|12/08/2004|APWD|APPROVAL FOR THE BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA).  THE DEVICE IS INDICATED FOR:  THE VERSANT HCV RNA 3.0 ASSAY (BDNA) IS A SIGNAL AMPLIFICATION NUCLEIC ACID PROBE ASSAY FOR THE QUANTITATION OF HUMAN HEPATITIS C VIRAL RNA (HCV RNA) IN THE SERUM OR PLASMA (EDTA AND ACD) OF HCV-INFECTED INDIVIDUALS USING THE BAYER SYSTEM 340 BDNA ANALYZER.  SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE BEEN VALIDATED FOR QUANTITATION IN THE ASSAY.  THE VERSANT HCV RNA 3.0 ASSAY IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTI-VIRAL THERAPY.  THE ASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND ARE USEFUL IN PREDICTING NON-RESPONSE TO HCV THERAPY, AND ARE PREDICTIVE OF NON-SUSTAINED VIROLOGICAL RESPONSE.  THE RESULTS FROM THE VERSANT HCV RNA 3.0 ASSAY (BDNA) MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.  ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED ONLY FOR INDIVIDUALS TREATED WITH INTERFERON ALFA-2B PLUS RIBAVIRIN.  NO INFORMATION IS AVAILABLE ON THE ASSAY PREDICTIVE VALUES WHEN OTHER THERAPIES ARE USED.
P020023||Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|||N|06/19/2002|12/12/2003|04M-0309|07/16/2004|APPR|APPROVAL FOR THE RESTYLANE INJECTABLE GEL.  THE DEVICE IS INDICATED FOR MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS.
P020024||AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM|MAE|CV|||N|06/24/2002|05/14/2003|06M-0075|02/16/2006|APPR|APPROVAL FOR THE AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM.  THE PERCUTANEOUS, TRANSCATHETER OCCLUSION DEVICE IS INDICATED FOR THE NON-SURGICAL CLOSURE OF PATENT DUCTUS ARTERIOSUS (PDA).
P020025||BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM|OAD|CV|||N|06/24/2002|08/25/2003|03M-0427|09/17/2003|APPR|APPROVAL FOR THE EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM. THE BLAZER II XP CARDIAC ABLATION CATHETER IS INDICATED FOR USE WITH THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.  THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.
P020026||CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER|NIQ|CV|||Y|06/28/2002|04/24/2003|03M-0172|09/08/2004|APPR|APPROVAL FOR THE CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS OF LENGTH <= 30 MM IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER OF >= 2.5 TO <= 3.5 MM.  LONG-TERM OUTCOME (BEYOND 12 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P020027||SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS|MTG|IM|||N|07/05/2002|01/24/2003|03M-0046|02/05/2003|APPR|APPROVAL FOR THE DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS.  THE DIMENSION FPSA FLEX REAGENT CARTRIDGE IS INDICATED FOR:  THE FPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE FREE PROSTATE SPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM.  MEASUREMENT OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) METHOD ON DIMENSION SYSTEM TO CALCULATE FPSA TO TPSA RATIO EXPRESSED AS A PERCENT FPSA.  THE PERCENT FPSA IS USED AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATE CONDITIONS IN MEN 50 YEARS OR OLDER WITH TPSA OF 4.0 TO 10.0 NG/ML [UG/L] AND DIGITAL RECTAL EXAMINATION (DRE) FINDINGS NOT SUSPICIOUS FOR CANCER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.  THE DIMENSION T/F PSA CALIBRATOR IS INDICATED FOR: THE T/F PSA CALIBRATOR IS AN IN VITRO DIAGNOSTIC PRODUCT INTENDED TO BE USED TO CALIBRATE THE TOTAL (TPSA) AND FREE (FPSA) PROSTATE SPECIFIC ANTIGEN METHODS FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE.  THIS PRODUCT WAS DESIGNED TO MEET THE NEEDS OF USERS TO ASSURE ACCURATE RESULTS OVER THE ASSAY RANGE OF THESE METHODS.
P020028||PHILIPS MEDICAL SYSTEMS, INC.|3000 MINUTEMAN RD. MS 0491||ANDOVER|MA|01810|1099|OXIMETER, FETAL PULSE|SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING|MMA|OB|||N|07/09/2002|01/03/2003|03M-0241|06/25/2003|APWD|APPROVAL FOR THE SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING, M1365A FETAL SPO2 PATIENT MODULE, AND THE NELLCOR OXIFIRST FS14 SENSOR.  THIS DEVICE IS INTENDED FOR CONTINUOUS MONITORING OF INTRAPARTUM FETAL OXYGEN SATURATION (FSPO2) AND THE FSPO2 PARAMETER IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE (FHR) MONITORING IN THE PRESENCE OF A NONREASSURING FETAL HEART RATE PATTERN.  IT SHOULD ONLY BE USED AFTER AMNIOTIC MEMBRANES HAVE RUPTURED AND ON A SINGLETON FETUS IN VERTEX PRESENTATION WITH A GESTATIONAL AGE GREATER THAN OR EQUAL TO 36 WEEKS.
P020030||SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD|NVN|CV|||N|07/19/2002|06/17/2004|04M-0310|07/16/2004|APPR|APPROVAL FOR THE STELID II, STELIX, AND STELIX II ENDOCARDIAL PACING LEADS.  THE STELID II, STELIX, AND STELIX II ENDOCARDIAL STEROID ELUTING PACING LEADS ARE DESIGNED TO BE USED WITH AN IMPLANTABLE PACEMAKER FOR PACING AND SENSING OF THE HEART.  THE STELID II MODELS BTF25D/26D AND UTF25D/26D ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE VENTRICLE.  THE STELID II MODELS BJF24D/25D, STELIX MODELS BR45D/46D, AND STELIX II MODELS BRF25D/26D ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE ATRIUM.
P020031||MICROSULIS MEDICAL LTD.|PARKLANDS BUSINESS PARK||DENMEAD HAMPSHIRE||PO7 6||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM|MNB|OB|||N|07/24/2002|09/23/2003|04M-0031|01/22/2004|APWD|APPROVAL FOR THE MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM.  THE DEVICE IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
P020033||INDEPENDENCE TECHNOLOGY, L.L.C.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Wheelchair, stair climbing|INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM|IMK|PM|||Y|07/31/2002|08/13/2003|03M-0375||APRL|APPROVAL FOR THE INDEPENDENCE  IBOT 3000 MOBILITY SYSTEM.  THE DEVICE IS INDICATED FOR INDIVIDUALS WHO HAVE MOBILITY IMPAIRMENTS AND THE USE OF AT LEAST ONE UPPER EXTREMITY.  THE DEVICE IS INTENDED TO PROVIDE UP TO FIVE OPERATING FUNCTIONS.  THE PURPOSES OF THESE FUNCTIONS ARE TO PROVIDE MOBILITY ON SMOOTH SURFACES AND INCLINES AT HOME, AT WORK AND IN OTHER ENVIRONMENTS; MOVEMENT ACROSS OBSTACLES, UNEVEN TERRAIN, CURBS, GRASS, GRAVEL, AND OTHER SOFT SURFACES; MOBILITY IN A SEATED POSITION AT AN ELEVATED HEIGHT; ASCENT AND DESCENT OF STAIRS WITH OR WITHOUT ASSISTANCE; AND MOBILITY AND TRANSPORTATION OF THE UNOCCUPIED PRODUCT.
P020035||St. Jude Medical, Inc.|6500 WEDGWOOD RD.||MAPLE GROVE|MN|55311||Device, hemostasis, vascular|X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM|MGB|CV|||N|09/03/2002|09/30/2003|09M-0406|09/25/2009|APWD|APPROVAL FOR THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM.  THE DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FRENCH IN SIZE.  THE DEVICE IS INTENDED TO REDUCE THE TIME TO HEMOSTASIS, TIME TO AMBULATION (100 FEET), AND TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CARDIAC CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS, INCLUDING THOSE PATIENTS RECEIVING GLYCOPROTEIN IIB/IIIA INHIBITORS.
P020036||CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|||N|09/05/2002|08/12/2003|03M-0381|08/26/2003|APPR|APPROVAL FOR THE S.M.A.R.T. NITINOL STENT SYSTEM AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM.  THE DEVICES ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 4 TO 9 MM, AND ANGIOGRAPHIC EVIDENCE OF A PATIENT PROFUNDA OR SUPERFICIAL FEMORAL ARTERY.
P020037||ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|||N|09/10/2002|06/11/2003|03M-0320|06/30/2003|APRL|APPROVAL FOR THE FX MINIRAIL TX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER.  THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY, INCLUDING IN-STENT RESTENOSIS, FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P020040||MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 8|POB 58165|TEL-AVIV||61581||STENT, CORONARY|NIRFLEX PREMOUNTED STENT|MAF|CV|||N|09/25/2002|10/24/2003|03M-0524|11/13/2003|APWD|APPROVAL FOR THE NIRFLEX PRE-MOUNTED CORONARY STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO AND RESTENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER FROM 2.5 MM TO 4.0 MM.
P020041||FEMCAP, INC.|14058 MIRA MONTANA DR.||DEL MAR|CA|92014|3455|CAP, CERVICAL, CONTRACEPTIVE|FEMCAP BARRIER CONTRACEPTIVE|LLQ|OB|||N|09/30/2002|03/28/2003|03M-0488|10/28/2003|APPR|APPROVAL FOR THE FEMCAP BARRIER CONTRACEPTIVE.  THE FEMCAP IS INDICATED FOR USE BY WOMEN OF CHILDBEARING AGE WHO DESIRE TO PREVENT OR POSTPONE PREGNANCY.
P020045||Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|||N|10/23/2002|04/17/2003|05M-0475|11/28/2005|APPR|APPROVAL FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM.  THE DEVICE IS INDICATED FOR THE CRYOABLATION OF THE CONDUCTING TISSUES OF THE HEART IN THE TREATMENT OF PATIENTS WITH ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT).
P020047||ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS|MAF|CV|||N|10/21/2002|07/16/2003|03M-0499|11/04/2003|APPR|APPROVAL FOR THE MULTI-LINK RX AND OTW VISION CORONARY STENT SYSTEMS (CSS).  THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <25 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM.  2)  PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <25 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM  3) RESTORING CORONARY FLOW IN PATIENTS EXPERIENCING ACUTE MYOCARDIAL INFARCTION, AS CONFIRMED BY ST SEGMENT ELEVATION OR ANGIOGRAPHIC FINDINGS, WHO PRESENT WITHIN 12 HOURS OF SYMPTOM ONSET WITH NATIVE CORONARY ARTERY LESIONS OF LENGTH <25 MM WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM.  OUTCOME (BEYOND 9 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P020049||LEMAITRE VASCULAR INC|63 SECOND AVENUE||BURLINGTON|MA|01803||TISSUE GRAFT OF 6MM AND GREATER|PROCOL VASCULAR BIOPROSTHESIS|LXA|CV|||N|11/12/2002|07/29/2003|03M-0352|08/07/2003|APPR|APPROVAL FOR THE PROCOL VASCULAR BIOPROSTHESIS.  THE DEVICE IS INDICATED FOR THE CREATION OF A BRIDGE GRAFT FOR VASCULAR ACCESS SUBSEQUENT TO AT LEAST ONE PREVIOUSLY FAILED PROSTHETIC ACCESS GRAFT.
P020050||Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|||N|11/20/2002|10/07/2003|03M-0491|10/28/2003|APPR|APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM.  THE DEVICE USED OPTICAL ZONES OF 6.0 AND 6.5 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, AND S INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK):  1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO -12.0 DIOPTERS (D) OF SPHERE AND UP TO -6.0 D OF ASTIGMATISM AT THE SPECTACLE PLANE;  2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND  3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P020052||St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|RESPONSE CV CATHETER SYSTEM|MTE|CV|||N|12/02/2002|05/07/2003|03M-0343|08/26/2003|APWD|APPROVAL FOR THE RESPONSE CV CATHETER SYSTEM, WHICH INCLUDES THE FOLLOWING COMPONENTS: SJM CARDIOVERSION RESPONSE (CV) ELECTROPHYSIOLOGY CATHETER; SJM CV ELECTROPHYSIOLOGY EXTENSION CABLE; SJM CARDIOVERSION SWITCHBOX SYSTEM; AND SJM CARDIOVERSION CABLE.  THIS SYSTEM IS INDICATED AS FOLLOWS:  THE SJM CARDIOVERSION RESPONSE (CV) ELECTROPHYSIOLOGY CATHETER WHEN USED WITH THE SJM CV ELECTROPHYSIOLOGY EXTENSION CABLE AND SJM SWITCHBOX SYSTEM IS INDICATED FOR USE IN THE INVASIVE EVALUATION OF CARDIAC ARRHYTHMIAS AND CAN BE USED FOR INTRACARDIAC CARDIOVERSION OF ATRIAL TACHYARRHYTHMIAS.  THE SJM CV ELECTROPHYSIOLOGY EXTENSION CABLE IS INTENDED TO CONNECT A SJM RESPONSE (CV) CARDIOVERSION ELECTROPHYSIOLOGY CATHETER TO A SJM CARDIOVERSION SWITCHBOX SYSTEM.  THE SJM CARDIOVERSION SWITCHBOX SYSTEM IS INTENDED TO CONNECT A SJM CARDIOVERSION (CV) ELECTROPHYSIOLOGY CATHETER AND SJM CV ELECTROPHYSIOLOGY EXTENSION CABLE TO A COMPATIBLE CARDIOVERTER/ DEFIBRILLATOR AND EP RECORDING SYSTEM.  THE SJM CARDIOVERSION CABLE IS INTENDED TO CONNECT THE SJM CARDIOVERSION SWITCHBOX SYSTEM TO A COMPATIBLE CARDIOVERTER.
P020055||VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY|NKF|PA|||N|12/24/2002|08/11/2004|05M-0159|05/02/2005|APPR|APPROVAL FOR THE VENTANA  MEDICAL SYSTEMS' PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY.  THE DEVICE IS INDICATED AS FOLLOWS: VENTANA MEDICAL SYSTEMS' PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY IS INTENDED FOR LABORATORY USE, VIA LIGHT MICROSCOPY, FOR THE QUALITATIVE DETECTION OF KIT PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED GASTROINTESTINAL STROMAL TUMORS (GISTS) USING EITHER AN AUTOMATED IMMUNOHISTOCHEM-ISTRY STAINING SYSTEM OR A MANUAL ASSAY.  IT IS INDICATED AS AN AID IN THE DIAGNOSIS OF GIST WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY, TUMOR MORPHOLOGY, AND OTHER DIAGNOSTIC TESTS EVALUATED BY A QUALIFIED PATHOLOGIST.  IT MAY BE USED AFTER THE DIAGNOSIS OF GIST AS AN AID IN THE SELECTION OF GIST PATIENTS WHO MAY QUALIFY FOR IMATINIB MESYLATE (GLEEVEC ) THERAPY.  PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY IS OPTIMIZED FOR USE ON VENTANA AUTOMATED SLIDE STAINER AND FOR MANUAL APPLICATION IN COMBINATION WITH VENTANA MEDICAL SYSTEMS' IVIEW DAB DETECTION KIT AND ACCESSORIES.  THE CLINICAL INTERPRETATION OF ANY STAINING, OR THE ABSENCE OF STAINING, MUST BE COMPLEMENTED BY MORPHOLOGICAL STUDIES AND EVALUATION OF PROPER CONTROLS.  EVALUATION MUST BE MADE BY A QUALIFIED PATHOLOGIST WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY AND OTHER DIAGNOSTIC TESTS.
P020056||Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|||N|12/30/2002|11/17/2006|06M-0490|11/17/2006|APPR|APPROVAL FOR THE INAMED SILICONE-FILLED BREAST IMPLANTS.  THIS DEVICE IS INDICATED FOR BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD AND FOR BREAST RECONSTRUCTION FOR WOMEN OF ANY AGE.  BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY.  BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY.  BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
P030002||Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|NAA|OP|||Y|01/24/2003|11/14/2003|04M-0012|01/12/2004|APPR|APPROVAL FOR THE CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER IOL.  THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND IS INTENDED TO PROVIDE NEAR, INTERMEDIATE AND DISTANCE VISION WITHOUT SPECTACLES.  THE CRYSTALENS IOL PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION.
P030004||EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM|MFE|NE|||N|03/18/2003|07/21/2005|05M-0328|08/22/2005|APPR|APPROVAL FOR THE ONYX LIQUID EMBOLIC SYSTEM (LES).  THE DEVICE IS INDICATED FOR PRESURGICAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS.
P030005||GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE|NKE|CV|||N|03/24/2003|01/26/2004|04M-0064|02/24/2004|APPR|APPROVAL FOR THE CONTAK RENEWAL TR.  THE DEVICE IS INDICATED S FOLLOWS:  THE CONTAK RENEWAL TR PULSE GENERATOR IS INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION).  THE DEVICE PROVIDES ATRIAL-VENTRICULAR TRACKING MODES TO HELP PRESERVE AV SYNCHRONY, AND ADAPTIVE-RATE PACING FOR PATIENTS WHO WOULD BENEFIT FROM ADJUSTED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.
P030006||MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION  SYSTEM|MEQ|GU|||N|03/24/2003|02/19/2004|04M-0116|03/09/2004|APPR|APPROVAL THE PROLIEVE THERMODILATATION SYSTEM, WHICH IS A TRANSURETHRAL MICROWAVE THERAPY DEVICE THAT PROVIDES A NON-SURGICAL, MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF SYMPTOMATIC BHP IN MEN WITH A PROSTATE SIZE OF 20 TO 80 GRAMS, A PROSTATIC URETHRA LENGTH OF 1.2 TO 5.5 CM AND IN WHOM DRUG THERAPY (E.G., PROSCAR) IN TYPICALLY INDICATED.
P030007||CARESTREAM HEALTH,INC.|150 Verona Street||ROCHESTER|NY|14608||Analyzer,medical image|KODAK MAMMOGRAPHY CAD ENGINE|MYN|RA|||N|03/31/2003|11/23/2004|05M-0087|03/09/2005|APWD|APPROVAL FOR THE KODAK MAMMOGRAPHY CAD ENGINE.  THE KODAK MAMMOGRAPHY CAD ENGINE IS A SOFTWARE PACKAGE INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING AND DIAGNOSTIC MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SOFTWARE ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P030008||Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|||N|03/19/2003|10/10/2003|03M-0492|10/28/2003|APPR|APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM.  THE DEVICES USES OPTICAL ZONES OF 6.0 AND 6.5 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK):  1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 DIOPTERS (D) OF SPHERE WITH AND WITHOUT ASTIGMATIC REFRACTIVE ERRORS UP TO 5.0 D AT THE SPECTACLE PLANE, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D;  2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND  3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY, EXCLUSIVE OF CHANGES DUE TO UNMASKING LATENT HYPEROPIA.
P030009||MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS|MAF|CV|||N|04/10/2003|10/01/2003|03M-0490|10/28/2003|APPR|APPROVAL FOR THE DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS.  THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS WITH REFERENCE VESSEL DIAMETERS OF 3.0 - 4.0 MM AND <= 30 MM IN LENGTH USING DIRECT STENTING OR PRE-DILATATION.  OUTCOME BEYOND 270 DAYS FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P030010||SIEMENS MEDICAL SOLUTION|51 VALLEY STREAM PKWY.||MALVERN|PA|19355||Full field digital,system,x-ray,mammographic|SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|||N|04/10/2003|08/20/2004|04M-0387|09/03/2004|APRL|APPROVAL FOR THE SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.  THE DEVICE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER AND IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHIC SYSTEMS.  THESE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY EITHER HARDCOPY FILM OR BY SOFTCOPY AT A WORKSTATION.
P030011||SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)|LOZ|CV|||N|04/11/2003|10/15/2004|04M-0471|10/27/2004|APPR|APPROVAL FOR THE SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T).  THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANT IN CARDIAC TRANSPLANT-ELIGIBLE CANDIDATES AT RISK OF IMMINENT DEATH FROM BIVENTRICULAR FAILURE.  ALSO, THE TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T) IS INTENDED FOR USE INSIDE THE HOSPITAL.
P030012||HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Lung computed tomography system, computer-aided diagnosis|IMAGECHECKER CT CAD SOFTWARE SYSTEM|NRR|RA|||N|04/16/2003|07/08/2004|04M-0323|07/22/2004|APCB|APPROVAL FOR THE IMAGECHECKER CT CAD SOFTWARE SYSTEM - MODEL LN-1000.  THIS SOFTWARE SYSTEM IS INDICATED TO ASSIST RADIOLOGISTS IN THE DETECTION OF SOLID PULMONARY NODULES DURING REVIEW OF MULTIDETECTOR CT (MDCT) SCANS OF THE CHEST.  IT IS INTENDED TO BE USED AS AN ADJUNCT, ALERTING THE RADIOLOGIST - AFTER HIS OR HER INITIAL READING OF THE SCAN - TO REGIONS OF INTEREST (ROIS) THAT MAY HAVE BEEN INITIALLY OVERLOOKED.
P030016||STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|VISIAN ICL (IMPLANTABLE COLLAMER LENS)|MTA|OP|||Y|05/08/2003|12/22/2005|06M-0340|08/25/2006|APPR|APPROVAL FOR THE VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODELS MICL12.1, MICL12.6, MICL13.2 AND MICL13.7.  THE DEVICE IS INDICATED FOR ADULTS 21-45 YEARS OF AGE: 1) TO CORRECT MYOPIA RANGING FROM -3.0 DIOPTERS TO <=-15.0 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) TO REDUCE MYOPIA RANGING FROM GREATER THAN -15.0 DIOPTERS TO -20.0 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE; AND 3) WITH AN ANTERIOR CHAMBER DEPTH (ACD) 3.00 MM OR GREATER, AND A STABLE REFRACTIVE HISTORY WITHIN 0.5 DIOPTER FOR 1 YEAR PRIOR TO IMPLANTATION.
P030017||Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|||N|05/14/2003|04/27/2004|04M-0256|06/10/2004|APPR|APPROVAL FOR THE PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM.  THE DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P030019||Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|||N|05/30/2003|02/04/2004|06M-0339|08/24/2006|APPR|APPROVAL FOR THE ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN.  THE DEVICE IS INDICATED FO THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
P030022||Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR SYSTEM|MRA|OR|||N|06/11/2003|12/17/2004|05M-0027|01/21/2005|APPR|APPROVAL FOR THE REFLECTION CERAMIC ACETABULAR SYSTEM.  THE DEVICE IS INDICATED FOR USE IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, OR TRAUMATIC ARTHRITIS.
P030023||OPHTEC USA, INC.|6421 CONGRESS AVE., SUITE 112||BOCA RATON|FL|33487||Ring, endocapsular|OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US|MRJ|OP|||N|06/17/2003|04/27/2004|04M-0248|05/26/2004|APPR|APPROVAL FOR THE OCULAID CAPSULAR TENSION RING (MODEL 275 10/12 MM AND MODEL 276 11/13 MM), ALSO KNOWN AS THE STABLEYES CAPSULAR TENSION RING (MODEL 275 10/12 MM AND MODEL 276 11/13 MM), TO BE DISTRIBUTED BY ADVANCED MEDICAL OPTICS.  THE DEVICE IS INDICATED FOR THE STABILIZATION OF WEAKENED, BROKEN OR MISSING ZONULES THAT ARE SUSPECTED OR OBSERVED DURING CATARACT EXTRACTION USING PHACOEMULSIFICATION AND CONTINUOUS CURVILINEAR CAPSULORHEXIS TECHNIQUES IN ADULTS.
P030024||ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR|LOM|MI|||N|06/19/2003|03/04/2004|04M-0341|08/04/2004|APPR|APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR.  THESE DEVICES ARE INDICATED FOR:  1) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK IS INDICATED FOR THE IN VITRO  QUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B CORE ANTIGEN (TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUM USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM.  ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION.  THE PRESENCE OF ANTI-HBC MAY BE USED AS AN AID IN THE DETERMINATION OF EXPOSURE TO HBV INFECTION FOR INDIVIDUALS PRIOR TO HBV VACCINATION.  2) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM WHEN USED FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B CORE ANTIGEN (TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUM USING VITROS ANTI-HBC REAGENT PACKS.
P030025||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|||N|06/19/2003|03/04/2004|04M-0403|09/08/2004|APPR|APPROVAL FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE).  THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >= 2.5 TO <= 3.75 MM IN DIAMETER.
P030026||Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR|LOM|MI|||N|06/27/2003|03/04/2004|04M-0356|08/09/2004|APPR|APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR.  THESE DEVICES ARE INDICATED FOR:  1) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (HEPARIN, EDTA AND CITRATE) AND NEONATE SERUM USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM.  ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B.   2) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR IS INDICATED FOR THE USE IN THE CALIBRATION OF THE VITROS IMMUNODIAGNOSTIC SYSTEM FOR THE IN VITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA, HEPARIN OR CITRATE) AND NEONATE SERUM USING VITRO ANTI-HBC IGM REAGENT PACKS.
P030027||MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002|0000|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND HIP ARTICULATION|MRA|OR|||N|06/12/2003|07/07/2003|03M-0356|08/12/2003|APPR|APPROVAL FOR THE TRANSCEND HIP ARTICULATION SYSTEM.  THE DEVICE IS INDICATED FOR PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.
P030028||OPHTEC BV|6421 CONGRESS AVE,SUITE 112||BOCA RATON|FL|33487||LENS, INTRAOCULAR, PHAKIC|ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)|MTA|OP|||Y|07/01/2003|09/10/2004|05M-0026|01/21/2005|APPR|APPROVAL FOR THE ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS, ALSO KNOWN AS THE VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS TO BE DISTRIBUTED BY ADVANCE MEDICAL OPTICS.  THE DEVICE IS INDICATED FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIA IN ADULTS WITH MYOPIA RANGING FROM -5 TO -20 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE AND WHOSE EYES HAVE AN ANTERIOR CHAMBER DEPTH GREATER THAN OR EQUAL TO 3.2 MILLIMETERS; AND, 2) PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 6 MONTHS, AS DEMONSTRATED BY SPHERICAL EQUIVALENT CHANGE OF LESS THAN OR EQUAL TO 0.50 DIOPTERS.
P030029||SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS|LOM|MI|||N|07/02/2003|05/14/2004|05M-0025|01/21/2005|APWD|APPROVAL FOR THE ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND ADVIA CENTAUR ANTI-HBS READYPACK CALIBRATORS.  THE DEVICE IS INDICATED FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM.  THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV  DISEASE ASSOCIATED WITH HBV INFECTION.  A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IN UNKNOWN.
P030030||C.R. Bard, Inc.|13183 HARLAND DRIVE||COVINGTON|GA|30014|6421|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|URYX URETHRAL BULKING AGENT|LNM|GU|||N|06/23/2003|12/16/2004|05M-0089|03/09/2005|APWD|APPROVAL FOR THE URYX URETHRAL BULKING AGENT (URYX).  THE DEVICE IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).
P030031||BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS|OAD|CV|||N|07/28/2003|11/05/2004|04M-0497|11/12/2004|APPR|APPROVAL FOR FOR THE NAVISTAR/CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS, WHICH INCLUDE THESE MODELS: NAVISTAR THERMOCOOL (MODELS NS75T-BCT-252-HS, NS75T-CCT-252-HS, NS75T-DCT-252-HS, NS75T-FCT-252-HS, NS75TC-BCT-252-HS, NS75TC-CCT-252-HS, NS75TC-DCT-252-HS, AND NS75TC-FCT-252-HS); AND CELSIUS THERMOCOOL (MODELS D7IT-BL-252-RT, D7IT-DL-252-RT, D7IT-FL-252-RT, D7ITC-BL-252-RT, D7ITC-DL-252-RT, AND D7ITC-FL-252-RT).  THE BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 GENERATOR, FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.  THE NAVISTAR THERMOCOOL CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO EP/XP NAVIGATION SYSTEM.
P030032||GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|HYLAFORM (HYLAN B GEL)|LMH|SU|||N|08/01/2003|04/22/2004|04M-0199|05/05/2004|APWD|APPROVAL FOR THE HYLAFORM.  THE DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
P030034||Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM|LOF|OR|||N|08/22/2003|12/23/2004|05M-0028|01/21/2005|APPR|APPROVAL FOR THE CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM.  THE CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM IS A NON-INVASIVE, PULSED ELECTROMAGNETIC BONE GROWTH STIMULATOR INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSION.
P030035||St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ANTHEM AND FRONTIER II CRT-P'S|NKE|CV|||N|08/29/2003|05/13/2004|04M-0250|05/26/2004|APPR|APPROVAL FOR THE ST. JUDE FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM.  THE FRONTIER BIVENTRICULAR PACING SYSTEM IS INDICATED FOR MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P030037||BIOTRONIK GMBH & CO. KG|WOERMANNKEHRE 1||BERLIN||D-123|1235|STENT, CORONARY|RITHRON-XR CORONARY STENT SYSTEM|MAF|CV|||N|09/02/2003|04/29/2005|05M-0193|05/18/2005|APPR|APPROVAL FOR THE RITHRON-XR CORONARY STENT SYSTEM.  THE DEVICE IS INDICATED FOR USE IN PATIENTS ELIGIBLE FOR BALLOON ANGIOPLASTY WITH SYMPTOMATIC ISCHEMIC HEART DISEASE CHARACTERIZED BY DISCRETE DE NOVO CORONARY ARTERY LESIONS WITH REFERENCE VESSEL DIAMETER FROM >=3.0 MM OR <=4.0 MM AND TARGET LESION LENGTH <=20.0 MM.
P030036||MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|MEDTRONIC SELECTSECURE LEAD MODEL 3830|NVN|CV|||N|09/04/2003|08/03/2005|05M-0380|09/23/2005|APPR|APPROVAL FOR THE SELECTSECURE LEAD MODEL 3830.  THE MODEL 3830 LEAD HAS APPLICATIONS WHERE IMPLANTABLE ATRIAL OR VENTRICULAR, SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED.  THE MODEL 3830 LEAD IS INTENDED FOR PACING AND SENSING IN THE ATRIUM OR VENTRICLE.
P030039||BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|||N|07/16/2003|12/12/2003|03M-0560|12/31/2003|APPR|APPROVAL FOR REFERENCE RIGHTS TO P010022.  THE DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
P030040||SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR  HBC IGM QUALITY CONTROL MATERIALS|LOM|MI|||N|09/11/2003|08/06/2004|05M-0158|05/02/2005|APPR|APPROVAL FOR THE ADVIA CENTAUR HBC IGM.  HBC IGM READY PACK REAGENTS: THIS DEVICE IS INDICATED FOR USE FOR THE ADVIA CENTAUR HBC IGM ASSAY AND IS AN IN VITRO  DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION IF IGM RESPONSE TO HEPATITIS B VIRUS CORE ANTIGEN IN HUMAN SERUM AND PLASMA (EDTA OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM.  THE ASSAY USES RECOMBINANT HBC ANTIGEN.  THIS ASSAY MAY BE USED IN COMBINATION WITH OTHER HEPATITIS B VIRUS (HBV) MARKET ASSAYS TO DEFINE THE CLINICAL STATUS OF KNOWN HBV INFECTED PATIENTS OR CAN BE COMBINED WITH OTHER HBV, HAV (HEPATITIS A VIRUS), AND HCV (HEPATITIS C VIRUS) ASSAYS FOR THE DIAGNOSIS OF PATIENTS PRESENTING SYMPTOMS OF ACUTE VIRAL HEPATITIS.  ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR IMMUNOCOMPRO-MISED OR IMMUNOSUPPRESSED PATIENTS, CORD BLOOD, NEONATAL SPECIMENS, INFANTS OR CHILDREN.  ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HBC IGM ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HBV SEROLOGICAL MARKERS.  HBC IGM QUALITY CONTROL MATERIALS: THE CONTROLS ARE INDICATED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HBC IGM ASSAY ON THE ADVIUA CENTAUR SYSTEMS.  THE PERFORMANCE OF THE HBC IGM QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC IGM ASSAYS.
P030042||MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM|NXT|OR|||Y|09/30/2003|11/03/2009|09M-0540|11/18/2009|APWD|APPROVAL FOR THECONSERVE PLUS TOTAL RESURFACING HIP SYSTEM.THE CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION UTILIZING CEMENTED FEMORAL HEAD COMPONENT AND CEMENTLESS ACETABULAR COMPONENT. THECONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS INTENDED FOR USE IN RESURFACING HIPARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATUREPATIENTS HAVING THE FOLLOWING CONDITIONS:1) NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS,TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS, OR DYSPLASIA/ DEVELOPMENTAL DISLOCATION OF THEHIP (DDH), OR2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.THE CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIRRELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIPARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING FUTURE IPSILATERAL HIP JOINT REVISION.
P030044||DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, epidermal growth factor receptor|DAKOCYTOMATION EGFR PHARMDX|NQF|PA|||N|09/29/2003|02/12/2004|04M-0433|09/24/2004|APPR|APPROVAL FOR THE DAKOCYTOMATION EGFR PHARMDX.  THE DEVICE IS INDICATED FOR:  THE EGFR PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM TO IDENTIFY EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXPRESSION IN NORMAL AND NEOPLASTIC TISSUES ROUTINELY-FIXED FOR HISTOLOGICAL EVALUATION.  EGFR PHARMDX SPECIFICALLY DETECTS THE EGFR (HER1) PROTEIN IN EGFR-EXPRESSING CELLS.  EGFR PHARMDX IS INDICATED AS AN AID IN IDENTIFYING COLORECTAL CANCER PATIENTS ELIGIBLE FOR TREATMENT WITH ERBITUX (CETUXIMAB).
P030045||MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, ILIAC|INTRASTENT DOUBLESTRUT STENT|NIO|CV|||N|09/30/2003|06/08/2004|04M-0259|06/14/2004|APPR|APPROVAL FOR THE INTRASTENT DOUBLESTRUT STENT.  THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 10 MM.
P030047||CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL STENT SYSTEM|NIM|CV|||Y|10/08/2003|09/22/2006|06M-0412|10/17/2006|APPR|APPROVAL FOR THE CORDIS PRECISE NITINOL STENT SYSTEM (5.5 FR AND 6.0 FR SIZES, OVER-THE-WIRE CONFIGURATION).  THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY (DEFINED IN THE IFU) WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM, AND 2) PATIENTS MUST HAVE A VESSEL DIAMETER OF 4-9MM AT THE TARGET LESION.  THE VESSEL DISTAL TO THE TARGET LESION MUST BE WITHIN THE RANGE OF 3MM AND 7.5MM TO ALLOW FOR PLACEMENT OF THE ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE.
P030049||SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL|LOM|MI|||N|11/28/2003|05/26/2005|05M-0270|07/01/2005|APPR|APPROVAL FOR THE ADVIA CENTAUR HBSAG READYPACK REAGENTS, ADVIA CENTAUR HBSAG CONFIRMATORY READYPACK REAGENTS, AND ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL:  ADVIA CENTAUR HBSAG READY PACK INDICATIONS FOR USE: THE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM.  THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B INFECTIONS.  THE ASSAY MAY ALSO BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD.  ADVIA CENTAUR HBSAG CONFIRMATORY READY PACK INDICATION FOR USE: THE ADVIA CENTAUR HBSAG CONFIRMATORY  ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, LITHIUM OR SODIUM HEPARIN) USING THE ADVIA CENTAUR SYSTEM.  THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OF HBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIA CENTAUR HBSAG ASSAY.  ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL INDICATIONS FOR USE: FOR MONITORING THE PERFORMANCE OF THE HBSAG AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS.
P030050||Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AND SCULPTRA AESTHETIC|LMH|SU|||Y|12/01/2003|08/03/2004|04M-0350|08/09/2004|APPR|APPROVAL FOR SCULPTRA.  THE DEVICE IS INTENDED FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.
P030052||ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018|||UROVYSION BLADDER CANCER KIT||PA|||N|12/10/2003|01/24/2005|05M-0130|04/12/2005|APPR|APPROVAL FOR THE UROVYSION BLADDER CANCER KIT.  THE DEVICE IS INDICATED FOR:  THE UROVYSION BLADDER CANCER KIT (UROVYSION KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17 AND LOSS OF THE 9P21 LOCUS VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN URINE SPECIMENS FROM PERSONS WITH HEMATURIA SUSPECTED OF HAVING BLADDER CANCER.  RESULTS FROM THE UROVYSION KIT ARE INTENDED FOR USE, IN CONJUNCTION WITH AND NOT IN LIEU OF CURRENT STANDARD DIAGNOSTIC PROCEDURES, AS AN AID FOR INITIAL DIAGNOSIS OF BLADDER CARCINOMA IN PATIENTS WITH HEMATURIA AND SUBSEQUENT MONITORING FOR TUMOR RECURRENCE IN PATIENTS PREVIOUSLY DIAGNOSED WITH BLADDER CANCER.
P030053||MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS|FTR|SU|||N|12/12/2003|11/17/2006|06M-0492|11/17/2006|APPR|APPROVAL FOR THE MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD AND FOR BREAST RECONSTRUCTION FOR WOMEN OF ANY AGE.  BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY.  BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY.  BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
P030054||St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST JUDE MEDICAL EPIC HF SYSTEM|NIK|CV|||N|12/19/2003|06/30/2004|04M-0313|07/16/2004|APPR|APPROVAL FOR THE ST. JUDE MEDICAL EPIC HF SYSTEM AND THE ST. JUDE MEDICAL ATLAS + HF SYSTEM. THESE SYSTEMS ARE INDICATED FOR THE FOLLOWING: THE ST. JUDE MEDICAL EPIC HF AND ATLAS + HF SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. THE EPIC HF AND ATLAS + HF SYSTEMS ARE ALSO INTENDED TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION.
P030056||SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS|MZO|MI|||N|12/24/2003|12/22/2004|05M-0478|11/28/2005|APPR|APPROVAL FOR THE ADVIA CENTAUR HCV.  HCV READYPACK REAGENTS: THE ADVIA CENTAUR HCV ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM.  THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THE DIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS C INFECTION. HCV QUALITY CONTROL MATERIALS: FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HCV ASSAY ON THE ADVIA CENTAUR SYSTEMS.  THE PERFORMANCE OF THE HCV QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HCV ASSAYS.
P040001||MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM|NQO|OR|||Y|01/06/2004|11/21/2005|06M-0014|01/13/2006|APWD|APPROVAL FOR THE X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM.  THE DEVICE IS INDICATED FOR TREATMENT OF PATIENTS AGED 50 OR OLDER SUFFERING FROM NEUROGENIC INTERMITTENT CLAUDICATION SECONDARY TO A CONFIRMED DIAGNOSIS OF LUMBAR SPINAL STENOSIS (WITH X-RAY, MRI, AND /OR CT EVIDENCE OF THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CANAL NARROWING).  THE X STOP IS INDICATED FOR THOSE PATIENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCK/GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND HAVE UNDERGONE A REGIMEN OF AT LEAST 6 MONTHS OF NONOPERATIVE TREATMENT.  THE X STOP MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.
P040002||ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOLOGIX POWERLINK SYSTEM|MIH|CV|||N|01/08/2004|10/29/2004|04M-0533|12/08/2004|APPR|APPROVAL FOR THE ENDOLOGIX POWERLINK SYSTEM. THE POWERLINK SYSTEM BIFURCATED MODELS AND PROXIMAL CUFF AND LIMB EXTENSION ACCESSORIES ARE INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA. THE ENDOLOGIX POWERLINK SYSTEM IS INDICATED FOR PATIENTS WITH SUITABLE ANEURYSM MORPHOLOGY FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED DELIVERY SYSTEMS (A DIAMETER OF >= 7 MM). 2) NON-ANEURYSMAL AORTIC NECK BETWEEN THE RENAL ARTERIES AND THE ANEURYSM.  3) AORTIC LENGTH >= 1.0 CM LONGER THAN THE BODY PORTION OF THE CHOSEN BIFURCATED MODEL. 4) COMMON ILIAC ARTERY DISTAL FIXATION SITE.
P040003||INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000 SYSTEM|NRZ|OB|||Y|01/27/2004|10/22/2004|05M-0473|11/28/2005|APPR|APPROVAL FOR THE EXABLATE 2000 SYSTEM.  THE DEVICE IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE-OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE.  PATIENTS MUST HAVE A UTERINE SIZE OF LESS THAN 24 WEEKS AND HAVE COMPLETED CHILD BEARING.
P040004||SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS|LOM|MI|||N|01/30/2004|12/22/2004|05M-0109|03/21/2005|APPR|APPROVAL FOR THE ADVIA CENTAUR HBC TOTAL.  HBC TOTAL READYPACK REAGENTS: THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE CORE ANTIGEN OF THE HEPATITIS B VIRUS (HBC TOTAL) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM.  THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND IN THE DETERMINATION OF THE CLINICAL STATUS OF HBV-INFECTED INDIVIDUALS IN CONJUNCTION WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  THIS ASSAY CAN ALSO BE USED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.  HBC TOTAL QUALITY CONTROL MATERIALS:  THE CONTROLS ARE INDICATED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HBC TOTAL ASSAY ON THE ADVIA CENTAUR SYSTEMS.  THE PERFORMANCE OF THE HBC TOTAL QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC TOTAL ASSAYS.
P040005||DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|DAKOCYTOMATION HER2 FISH PHARMDX KIT|MVD|PA|||N|01/29/2004|05/03/2005|05M-0387|09/23/2005|APPR|APPROVAL FOR THE DAKOCYTOMATION HER2 FISH PHARMDX KIT.  THE DEVICE IS INDICATED FOR:  THE DAKOCYTOMATION HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU  HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE THE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS.  HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.  RESULTS FORM THE HER2 FISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGIC INFORMATION CURRENTLY USED FOR ESTIMATING PROGNOSIS IN STAGE II, NODE POSITIVE BREAST CANCER PATIENTS.
P040006||DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|CHARITE ARTIFICIAL DISC|MJO|OR|||Y|02/13/2004|10/26/2004|05M-0092|03/09/2005|APWD|APPROVAL FOR THE CHARITE ARTIFICIAL DISC.  THE DEVICE IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS SHOULD HAVE NO MORE THAN 3 MM OF SPONDYLOLISTHESIS AT THE INVOLVED LEVEL.  PATIENTS RECEIVING THE CHARITE ARTIFICIAL DISC SHOULD HAVE FAILED AT LEAST SIX MONTHS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE CHARITE ARTIFICIAL DISC.
P040008||bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TPSA ASSAY|MTF|IM|||N|02/17/2004|07/08/2004|04M-0342|08/04/2004|APPR|APPROVAL FOR THE VIDAS TPSA ASSAY INDICATED AS FOLLOWS: VIDAS TPSA IS INTENDED FOR USE WITH A VIDAS (VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM) INSTRUMENT AS AN AUTOMATED ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM.  THE VIDAS TPSA ASSAY IS INDICATED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATE CANCER AND AS AN AID IN THE DETECTION OF PROSTATE CANCER IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGE 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER.
P040011||DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry antibody assay, c-kit|C-KIT PHARMDX|NKF|PA|||N|03/12/2004|06/27/2005|05M-0388|09/23/2005|APPR|APPROVAL FOR THE DAKOCYTOMATION   C-KIT PHARMDX.  DAKOCYTOMATION C-KIT PHARMDX ON THE DAKO AUTOSTAINER: THE C-KIT PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM USED ON THE DAKO AUTOSTAINER, FOR THE IDENTIFICATION OF C-KIT PROTEIN/CD117 ANTIGEN (C-KIT PROTEIN) EXPRESSION IN NORMAL AND NEOPLASTIC FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUES FOR HISTOLOGICAL EVALUATION.  THE C-KIT PHARMDX RABBIT POLYCLONAL ANTIBODIES SPECIFICALLY DETECT THE C-KIT PROTEIN IN CD117 ANTIGEN-EXPRESSING CELLS.  THE C-KIT PHARMDX IS INDICATED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS OF GASTROINTESTINAL STROMAL TUMORS (GIST).  AFTER DIAGNOSIS OF GIST, RESULTS FROM C-KIT PHARMDX MAY BE USED AS AN AID IN IDENTIFYING THOSE PATIENTS ELIGIBLE FOR TREATMENT WITH GLEEVEC/GLIVEC (IMATINIB MESYLATE).  RESULTS FROM HEMATOXYLIN AND EOSIN (H&E) STAINS AND A PANEL OF ANTIBODIES CAN AID IN THE DIFFERENTIAL DIAGNOSIS OF GIST.  INTERPRETATION MUST BE MADE BY A QUALIFIED PATHOLOGIST, WITHIN THE CONTEXT OF A PATIENT'S CLINICAL HISTORY, PROPER CONTROLS, AND OTHER DIAGNOSTIC TEST.  DAKO CYTOMATION C-KIT PHARMDX FOR MANUAL USE: THE C-KIT PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM USED FOR THE IDENTIFICATION OF C-KIT PROTEIN/CD117 ANTIGEN (C-KIT PROTEIN) EXPRESSION IN NORMAL AND NEOPLASTIC FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUES FOR HISTOLOGICAL EVALUATION.  THE C-KIT PHARMDX RABBIT POLYCLONAL. ANTIBODIES SPECIFICALLY DETECT THE C-KIT PROTEIN IN CD117 ANTIGEN-EXPRESSING CELLS.  THE C-KIT PHARMDX IS INDICATED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS OF GASTROINTESTINAL STROMAL TUMORS (GIST).  AFTER DIAGNOSIS OF GIST, RESULTS FROM C-KIT PHARMDX MAY BE USED AS AN AID IN IDENTIFYING THOSE PATIENTS ELIGIBLE FOR TREATMENT WITH GLEEVEC/GLIVEC (IMATINIB MESYLATE).  RESULTS FROM HEMATOXYLIN AND EOSIN (H&E) STAINS AND A PANEL OF ANTIBODIES CAN AID IN THE DIFFERENTIAL DIAGNOSIS OF GIST.  INTERPRETATION MUST BE MADE BY A QUALIFIED PATHOLOGIST, WITHIN THE CONTEXT OF A PATIENT'S...
P040013||Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S (GROWTH-FACTOR ENHANCED MATRIX|NPZ|DE|||N|03/12/2004|11/18/2005|05M-0474|11/28/2005|APPR|APPROVAL FOR THE GEM 21S (GROWTH-FACTOR ENHANCED MATRIX).  THE DEVICE IS INDICATED TO TREAT THE FOLLOWING PERIODONTALLY RELATED DEFECTS: 1) INTRABONY PERIODONTAL DEFECTS 2) FURCATION PERIODONTAL DEFECTS 3) GINGIVAL RECESSION ASSOCIATED WITH PERIODONTAL DEFECTS.
P040012||ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|||Y|03/15/2004|08/30/2004|04M-0388|09/03/2004|APPR|APPROVAL FOR THE ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM.  THE ACCULINK CAROTID STENT SYSTEM AND THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH GUIDANT CAROTID EMBOLIC PROTECTION SYSTEMS, ARE INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW. 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM, AND2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION.
P040014||IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|IBI THERAPY CARDIAC ABLATION SYSTEM                    ERS/ 1500T RF GENERATOR|LPB|CV|||N|03/15/2004|01/14/2005|05M-0088|03/09/2005|APPR|APPROVAL FOR THE IBI THERAPY CARDIAC ABLATION SYSTEM.  THE DEVICE IS INDICATED FOR MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P040016||BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE-METAL CORONARY STEM SYSTEM|MAF|CV|||N|03/26/2004|04/12/2005|05M-0192|05/18/2005|APPR|APPROVAL FOR THE BOSTON SCIENTIFIC CORPORATION LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <=28 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.75 TO 5.00 MM.
P040017||BAYER HEALTHCARE, DIAGNOSTICS DIVISION|511 BENEDICT AVE.||TARRYTOWN|NY|10591||Hepatitis a test (antibody and igm antibody)|ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS|LOL|MI|||N|04/01/2004|03/07/2005|05M-0110|03/21/2005|APRL|APPROVAL FOR THE ADVIA CENTAUR HAV TOTAL ASSAY AND QUALITY CONTROL MATERIALS.  HAV TOTAL ASSAY INDICATION FOR USE: THE ADVIA CENTAUR HAV TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS A VIRUS (ANTI-HAV ) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM.  THIS ANTI-HAV ASSAY IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION.  HAV TOTAL QUALITY CONTROL MATERIALS INDICATION FOR USE: FOR MONITORING THE PERFORMANCE OF THE HAV TOTAL ASSAY ON ADVIA CENTAUR SYSTEMS.  THE PERFORMANCE OF THE HAV TOTAL QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HAV TOTAL ASSAY.
P040018||BAYER HEALTHCARE, LLC|511 BENEDICT AVE.||TARRYTOWN|NY|10591||Hepatitis a test (antibody and igm antibody)|ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS|LOL|MI|||N|04/01/2004|12/22/2004|05M-0129|04/12/2005|APRL|APPROVAL FOR THE ADVIA CENTAUR HAV IGM.  HAV IGM READYPACK REAGENTS: THIS DEVICE IS INDICATED FOR USE FOR THE ADVIA CENTAUR HAV IGM ASSAY AND IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IGM RESPONSE TO THE HEPATITIS A VIRUS (HAV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM.  THE ASSAY IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT INFECTION (USUALLY 6 MONTHS OR LESS) WITH HEPATITIS A VIRUS.  HAV IGM QUALITY CONTROL MATERIALS: THE CONTROLS ARE INDICATED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HAV IGM ASSAY ON THE ADVIA CENTAUR SYSTEMS.  THE PERFORMANCE OF THE HAV IGM QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HAV IGM ASSAYS.
P040020||Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL|MFK|OP|||N|04/19/2004|03/21/2005|05M-0117|04/12/2005|APPR|APPROVAL FOR THE ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), MODELS MA60D3 AND SA60D3.  THIS DEVICE IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE.  THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P040021||St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE|LWR|CV|||N|04/19/2004|08/05/2005|05M-0321|08/24/2005|APPR|APPROVAL FOR THE SJM BIOCOR VALVE AND THE SJM BIOCOR SUPRA VALVE.
P040022||Medtronic Vascular|37A Cherry Hill Drive||Danvers|MA|01923||Device, hemostasis, vascular|ANGIOLINK VASCULAR CLOSURE SYSTEM|MGB|CV|||N|04/26/2004|11/03/2004|04M-0496|11/12/2004|APWD|APPROVAL FOR THE EVS VASCULAR CLOSURE SYSTEM.  THE DEVICE IS INDICATED FOR PERCUTANEOUS FEMORAL ARTERY APPROXIMATION.  THE EVS VASCULAR CLOSURE SYSTEM IS ALSO INDICATED TO REDUCE TIME TO HEMOSTASIS AT FEMORAL PUNCTURE SITES AND TO REDUCE TIME TO AMBULATION FOR PATIENTS UNDERGOING DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 6-8 FRENCH PROCEDURAL SHEATHS.
P040023||DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|||N|05/04/2004|05/03/2005|06M-0512|12/20/2006|APWD|APPROVAL FOR THE DURALOC OPTION CERAMIC HIP SYSTEM.  THE DEVICE IS INDICATED FOR NON-CEMENTED USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND POST-TRAUMATIC ARTHRITIS.
P040024||Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|||N|05/10/2004|03/25/2005|05M-0118|04/12/2005|APPR|APPROVAL FOR THE RESTYLANE INJECTABLE GEL.  THE DEVICE IS INDICATED FOR MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS.
P040025||Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP|MXM|NE|||Y|05/28/2004|12/20/2006|06M-0530|12/26/2006|APPR|APPROVAL FOR THE OLYMPIC COOL-CAP.  THE OLYMPIC COOL-CAP IS INDICATED FOR USE IN FULL-TERM INFANTS WITH CLINICAL EVIDENCE OF MODERATE TO SEVERE HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE).  COOL-CAP PROVIDES SELECTIVE HEAD COOLING WITH MILD SYSTEMIC HYPOTHERMIA TO PREVENT OR REDUCE THE SEVERITY OF NEUROLOGIC INJURY ASSOCIATED WITH HIE.
P040026||MEDISPEC, LTD.|203 PERRY PARKWAY|Suite 6|GAITHERSBURG|MD|20877||Generator, shock-wave, for pain relief|ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE|NBN|PM|||N|06/04/2004|04/01/2005|05M-0241|06/20/2005|APPR|APPROVAL FOR THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE.  THE DEVICE IS INDICATED FOR THE TREATMENT OF PROXIMAL PLANTAR FASCIITIS WITH OR WITHOUT HEEL SPUR IN PATIENTS 18 YEARS OF AGE OR OLDER.  THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY IS A NON-INVASIVE ALTERNATIVE METHOD FOR PATIENT WITH SYMPTOMS OF PROXIMAL PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPIES TO RELIEVE HEEL PAIN.  PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE PLANTAR CALCANEAL TUBEROSITY.
P040027||W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS|MIR|CV|||Y|06/09/2004|12/06/2004|06M-0411|10/17/2006|APPR|APPROVAL FOR THE GORE VIATORR TIPS ENDOPROSTHESIS.  THE DEVICE IS INDICATED FOR USE IN DE NOVO AND REVISION TREATMENT OF PORTAL HYPERTENSION AND ITS COMPLICATIONS SUCH AS VARICEAL BLEEDING, GASTROPATHY, ASCITES, AND/OR HEPATIC HYDROTHORAX.
P040028||SPECTRA SCIENCE|11568 SORRENTO VALLEY RD|SUITE 11|SAN DIEGO|CA|92121||Sensor,electro-optical(for cervical cancer)|LUMA CERVICAL IMAGING SYSTEM|MWM|OB|||Y|06/18/2004|03/16/2006|06M-0148|04/12/2006|APWD|APPROVAL FOR THE LUMA CERVICAL IMAGING SYSTEM.  THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO COLPOSCOPY FOR THE IDENTIFICATION OF HIGH-GRADE DISEASE (CIN 2, 3+) IN WOMEN REFERRED TO COLPOSCOPY WITH A PAP TEST RESULT OF ATYPICAL SQUAMOUS CELLS (ASC), LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESION (LSIL) OR HIGH-GRADE SQUAMOUS INTRAEPITHELIAL LESION OR CANCER (HSIL+).
P040029||Euclid Systems Corporation|2776 Towerview Rd.||Herndon|VA|20171||Lens, contact, orthokeratology, overnight|JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR|NUU|OP|||N|06/21/2004|09/29/2004|04M-0450|10/12/2004|APPR|APPROVAL FOR THE JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR.  THE LENSES ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES.  THE LENSES ARE INDICATED FOR OVERNIGHT WEAR FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.50 DIOPTERS.  THE LENSES MAY ONLY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM.  NOTE: TO MAINTAIN THE ORTHOKERATOLOGY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE.  FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.
P040030||BIOGENEX LABORATORIES, INC.|4600 NORRIS CANYON RD.||SAN RAMON|CA|94583||SYSTEM, TEST, HER-2/NEU, IHC|INSITE HER-2/NEU KIT|MVC|PA|||N|06/22/2004|12/22/2004|05M-0160|05/02/2005|APWD|APPROVAL FOR THE INSITE HER-2/NEU KIT.  THE DEVICE IS INDICATED FOR:  INSITE HER-2/NEU MOUSE MONOCLONAL ANTIBODY (CLONE CB11) KIT IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN IMMUNOHISTOCHEM-ISTRY (IHC) ASSAYS TO SEMI-QUANTITATIVELY LOCALIZED BY LIGHT MICROSCOPY THE OVER-EXPRESSION OF HER-2/NEU (I.E., C-ERBB-2) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED NORMAL AND NEOPLASTIC TISSUE SECTIONS.  INSITE HER-2/NEU IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) THERAPY IS BEING CONSIDERED.  CLINICAL INTERPRETATION OF INSITE HER-2/NEU IMMUNOSTAINING RESULTS (ABSENCE OR PRESENCE; SEMI-QUANTITATIVE INTENSITY SCORE) SHOULD BE COMPLEMENTED BY APPROPRIATE CONTROLS AND MORPHOLOGICAL TISSUE ANALYSIS AND BE EVALUATED BY A QUALIFIED PATHOLOGIST WITHIN THE CONTEXT OF PATIENT CLINICAL HISTORY AND OTHER DIAGNOSTIC RESULTS.
P040033||SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|||Y|07/19/2004|05/09/2006|06M-0193|05/09/2006|APPR|APPROVAL FOR THE BIRMINGHAM HIP RESURFACING (BHR) SYSTEM.  THE BHR SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD COMPONENT AND CEMENTLESS ACETABULAR COMPONENT.  THE HGR SYSTEM IS INTENDED FOR USE IN PATIENTS REQUIRING PRIMARY HIP RESURFACING ARTHROPLASTY DUE TO: 1) NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS, OR DYSPLASIA/DEVELOPMENTAL DISLOCATION OF THE HIP (DDH), OR 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.  THE BHR SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING FUTURE IPSILATERAL HIP JOINT REVISION.
P040034||INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|||N|07/20/2004|04/07/2005|05M-0191|05/18/2005|APPR|APPROVAL FOR THE DURASEAL DURAL SEALANT SYSTEM.  THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING CRANIAL SURGERY TO PROVIDE WATERTIGHT CLOSURE.  DURASEAL SHOULD ONLY BE USED WITH AUTOLOGOUS DURAPLASTY MATERIAL.
P040036||BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER|LPB|CV|||N|08/19/2004|08/11/2006|06M-0374|09/12/2006|APPR|APPROVAL FOR THE NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS WHICH INCLUDE MODELS N175TBH, N175TCH, N175TDH, N175TFH, N175TCBH, N175TCCH, N175TCDH, N175TCFH, AND N175TCJH.  THE NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORY DEVICES, WHEN USED WITH THE STOCKERT 70 RADIOFREQUENCY (RF) GENERATOR, ARE INDICATED FOR THE TREATMENT OF RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS.THE NAVISTAR THERMOCOOL CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO EP / XP NAVIGATION SYSTEM, AND CAN BE USED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING).
P040037||W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|VIABAHN ENDOPROSTHESIS|NIP|CV|||N|08/27/2004|06/14/2005|05M-0379|09/23/2005|APPR|APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS.  THE DEVICE IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.8 TO 7.5 MM.
P040038||ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|||N|09/03/2004|09/06/2005|05M-0381|09/23/2005|APPR|APPROVAL FOR THE XACT CAROTID STENT SYSTEM.  THE XACT CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH THE ABBOTT VASCULAR DEVICES EMBOLIC PROTECTION SYSTEM, IS INDICATED FOR THE IMPROVEMENT OF THE LUMEN DIAMETER OF CAROTID ARTERIES IN PATIENTS CONSIDERED AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE PERCUTANEOUS CAROTID ANGIOPLASTY AND STENTING FOR OCCLUSIVE ARTERY DISEASE AND MEET THE CRITERIA OUTLINED AS FOLLOWS: 1) PATIENTS WITH CAROTID ARTERY STENOSIS (>= 50% FOR SYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY OR >= 80% FOR ASYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY), LOCATED BETWEEN THE ORIGIN OF THE COMMON CAROTID ARTERY AND THE INTRA-CRANIAL SEGMENT OF THE INTERNAL CAROTID ARTERY; AND 2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER RANGING BETWEEN 4.8 MM AND 9.1 MM AT THE TARGET LESION
P040039||ORTHOMETRIX, INC.|5621 STRAND BLVD|SUITE 111|NAPLES|FL|34110||Generator, shock-wave, for pain relief|ORBASONE PAIN RELIEF SYSTEM|NBN|OR|||N|09/14/2004|08/10/2005|05M-0339|08/25/2005|APWD|APPROVAL FOR THE ORBASONE PAIN RELIEF SYSTEM.  THE DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE THERAPY FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS IN PATIENTS 18 YEARS OF AGE OR OLDER THAT HAVE FAILED TO RESPOND TO CONSERVATIVE THERAPY.  CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
P040040||St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|||N|09/30/2004|09/07/2007|07M-0446|11/19/2007|APPR|APPROVAL FOR THE AMPLATZER MUSCULAR VSD OCCLUDER.  THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE (LARGE VOLUME LEFT TO RIGHT SHUNT, PULMONARY HYPERTENSION AND/OR CLINICAL SYMPTOMS OF CONGESTIVE HEART FAILURE) WHO ARE CONSIDERED TO BE AT HIGH RISK FOR STANDARD TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE BASED ON ANATOMICAL CONDITIONS AND/OR BASED ON OVERALL MEDICAL CONDITION.  HIGH RISK ANATOMICAL FACTORS FOR TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE INCLUDE PATIENTS: 1) REQUIRING LEFT VENTRICULOTOMY OR AN EXTENSIVE RIGHT VENTRICULOTOMY; 2) WITH A FAILED PREVIOUS VSD CLOSURE; 3) WITH MULTIPLE APICAL AND/OR ANTERIOR MUSCULAR VSDS (?SWISS CHEESE SEPTUM?); OR 4) WITH POSTERIOR APICAL VSDS COVERED BY TRABECULAE.
P040042||IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER|OAD|CV|||N|10/04/2004|11/18/2005|05M-0476|11/28/2005|APPR|APPROVAL FOR THE THERAPY DUAL 8 CARDIAC ABLATION SYSTEM.  THE DEVICE IS INDICATED FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
P040043||W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|||Y|10/04/2004|03/23/2005|05M-0320|08/12/2005|APPR|APPROVAL FOR THE TAG THORACIC ENDOPROSTHESIS AND DELIVERY CATHETER.  THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS.  2) AORTIC INNER DIAMETER IN THE RANGE OF 23-37 MM.  3) >=2 CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.
P040044||ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MATRIX VASCULAR CLOSURE SYSTEM (VSG)|MGB|CV|||N|11/04/2004|08/17/2005|05M-0359|09/08/2005|APPR|APPROVAL FOR THE MATRIX VSG SYSTEM, MODEL MX-100.  THE DEVICE IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F, OR 7F PROCEDURAL SHEATH.
P040045||VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|||N|11/15/2004|12/20/2005|05M-0504|12/27/2005|APPR|APPROVAL FOR THE VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER.  THE DEVICE IS INDICATED FOR USE AS FOLLOWS:  THE VISTAKON (SENOFILCON A) SOFT CONTACT LENS (SPHERICAL) IS INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO HAVE 1.00D OR LESS OF ASTIGMATISM.  THE VISTAKON (SENOFILCON A) MULTIFOCAL SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC, PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 0.75D OF ASTIGMATISM OR LESS.  THE VISTAKON (SENOFILCON A) TORIC SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF VISUAL ACUITY IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE HYPEROPIC OR MYOPIC AND MAY HAVE 10.00D OF ASTIGMATISM OR LESS.  THE VISTAKON (SENOFILCON A) MULTIFOCAL-TORIC SOFT CONTACT LENS  IS INDICATED FOR THE OPTICAL CORRECTION OF DISTANCE AND NEAR IN PRESBYOPIC PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 10.00D OF ASTIGMATISM OR LESS. THE VISTAKON (SENOFILCON A) UV BLOCKING SOFT CONTACT LENS HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.  EYE CARE PROFESSIONALS MAY PRESCRIBE THE LENSES EITHER FOR SINGLE-USE DISPOSABLE WEAR OR FREQUENT/PLANNED REPLACEMENT WEAR WITH CLEANING, DISINFECTION AND SCHEDULED REPLACEMENT.  WHEN PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR THE LENSES MAY BE CLEANED AND DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY.  VISTAKON (SENOFILCON A) CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR AND EXTENDED WEAR FOR UP TO 6 NIGHTS/7 DAYS OF CONTINUOUS WEAR.  IT IS RECOMMENDED THAT THE CONTACT LENS WEARER FIRST BE EVALUATED ON A DAILY WEAR SCHEDULE.  IF SUCCESSFUL, THEN A GRADUAL INTRODUCTION OF EXTENDED WEAR CAN BE FOLLOWED AS DETERMINED BY THE PRESCRIBING EYE CARE PROFESSIONAL.
P040046||Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|||N|12/06/2004|02/20/2013|13M-0255|03/13/2013|APPR|APPROVAL FOR THE NATRELLE® 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR WOMEN FOR THE FOLLOWING USES (PROCEDURES):1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD.  BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY; AND 2)  BREAST RECONSTRUCTION. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY. BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
P040047||MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE|LNM|GU|||N|12/09/2004|11/10/2005|05M-0477|11/28/2005|APPR|APPROVAL FOR COAPTITE.  THE DEVICE IS INDICATED FOR SOFT TISSUE AUGMENTATION IN THE TREATMENT OF STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD) IN ADULT FEMALES.
P040048||ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|||N|12/14/2004|06/28/2006|07M-0259|06/28/2007|APWD|APPROVAL FOR THE TRILOGY AB ACETABULAR SYSTEM.  THE DEVICE IS INDICATED FOR EITHER CEMENTED OR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY SURGERY FOR REHABILITATING HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.
P040050||UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|||N|12/22/2004|10/30/2006|06M-0457|11/08/2006|APPR|APPROVAL FOR MACROPLASTIQUE IMPLANTS.  THE DEVICE IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) PRIMARILY DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).
P040051||STELKAST COMPANY|200 HIDDEN VALLEY ROAD||MCMURRAY|PA|15317||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|STELKAST SURPASS  ACETABULAR SYSTEM|MRA|OR|||N|12/27/2004|05/12/2006|07M-0109|03/26/2007|APWD|APPROVAL FOR THE STELKAST SURPASS ACETABULAR SYSTEM.  THE DEVICE IS INDICATED FOR CEMENTLESS USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE INDIVIDUALS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.
P040052||HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|MONOPREP PAP TEST|MKQ|PA|||N|12/30/2004|03/03/2006|06M-0264|06/26/2006|APPR|APPROVAL FOR THE MONOPREP PAP TEST (MPPT).  THE DEVICE IS INTENDED FOR USE IN COLLECTING AND PREPARING CERVICAL-VAGINAL CYTOLOGY SPECIMENS FOR PAP STAIN-BASED SCREENING FOR CERVICAL CANCER, IT'S PRECURSOR LESIONS, AND OTHER CYTOLOGICAL CATEGORIES AND CONDITIONS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY.  THE MONOPREP PAP TEST PRODUCES SLIDES THAT ARE INTENDED TO REPLACE CONVENTIONALLY PREPARED PAP SMEAR SLIDES.
P050004||ELECTRO MEDICAL SYSTEMS (EMS SA)|CH. DE LA VUARPILLIERE 31||NYON, VAUD||CH-12|1260|Generator, shock-wave, for pain relief|EMS SWISS DOLORCLAST|NBN|SU|||N|02/02/2005|05/08/2007|07M-0253|06/28/2007|APPR|APPROAL FOR THE EMS SWISS DOLORCLAST.  THE EMS SWISS DOLORCLAST IS A NON-SURGICAL ALTERNATIVE INDICATED FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PATIENTS 18 YEARS OF AGE OR OLDER WITH SYMPTOMS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY.  CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDICAL CALCANEAL TUBEROSITY.
P050006||W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX  SEPTAL OCCLUDER|MLV|CV|||N|03/01/2005|08/11/2006|06M-0341|08/25/2006|APPR|APPROVAL FOR THE GORE HELEX SEPTAL OCCLUDER.  THE DEVICE IS A PERMANENTLY IMPLANTED PROSTHESIS INDICATED FOR THE PERCUTANEOUS, TRANSCATHETER CLOSER OF OSTIUM SECUNDUM ATRIAL SEPTAL DEFECTS (ASDS).
P050007||ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|||N|02/28/2005|12/21/2005|06M-0016|01/13/2006|APPR|APPROVAL FOR THE STARCLOSE VASCULAR CLOSURE SYSTEM.  THE DEVICE IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.
P050009||Biomet, Inc.|P.O. Box 587||Warsaw|IN|46581|0587|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|C2 A-TAPER ACETABULAR SYSTEM|MRA|OR|||N|03/14/2005|12/16/2005|06M-0015|01/13/2006|APWD|APPROVAL FOR THE C2A-TAPER ACETABULAR SYSTEM.  THE DEVICE IS INDICATED FOR USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND POST-TRAUMATIC ARTHRITIS.
P050010||SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC -L TOTAL DISC REPLACEMENT DEVICE|MJO|OR|||N|03/15/2005|08/14/2006|06M-0343|08/25/2006|APPR|APPROVAL FOR THE PRODISC-L TOTAL DISC REPLACEMENT.  THE DEVICE IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L3-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS SHOULD HAVE NO MORE THAN GRADE 1 SPONDYLOLISTHESIS AT THE INVOLVED LEVEL.  PATIENTS RECEIVING THE PRODISC-L TOTAL DISC REPLACEMENT SHOULD HAVE FAILED AT LEAST SIX MONTHS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE PRODISC-L TOTAL DISC REPLACEMENT.
P050011||BAXTER HEALTHCARE CORP.|1620 WAUKEGAN ROAD||MCGAW PARK|IL|60085||BARRIER, ABSORABLE, ADHESION|ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION|MCN|OB|||N|03/16/2005|07/28/2006|06M-0322|08/17/2006|APPR|APPROVAL FOR THE ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION.  THE DEVICE IS INDICATED FOR USE INTRAPERIOTONEALLY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE FOR THE REDUCTION OF POST-SURGICAL ADHESIONS IN PATIENTS UNDERGOING GYNECOLOGICAL LAPAROSCOPIC ADHESIOLYSIS.
P050012||DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM STS CONTINOUS MONITORS|MDS|CH|||N|03/23/2005|03/24/2006|06M-0200|05/12/2006|APWD|APPROVAL FOR THE DEXCOM STS CONTINUOUS GLUCOSE MONITORING SYSTEM.  THE DEVICE IS INDICATED FOR THE FOLLOWING: 1) INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN ADULTS (18 AND OLDER) WITH DIABETES AND IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES.  THE DEVICE IS FOR PRESCRIPTION USE. 2) INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. 3) AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS.  INTERPRETATION OF THE STS SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL SENSOR READINGS OVER TIME.
P050013||TISSUE SEAL LLC|5643 Plymouth Rd||Ann Arbor|MI|48105||Tissue adhesive for the topical approximation of skin|HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE|MPN|SU|||N|03/25/2005|02/16/2007|07M-0086|03/16/2007|APRL|APPROVAL FOR THE HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE.  THE DEVICE IS INDICATED FOR TOPICAL APPLICATION TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF MINIMUM-TENSION WOUNDS FROM CLEAN SURGICAL INCISIONS AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS.  HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE MAY BE USED IN CONJUNCTION WITH BUT NOT IN PLACE OF DERMAL SUTURES.
P050014||FUJIFILM MEDICAL SYSTEM U.S.A., INC.|419 WEST AVE.||STAMFORD|CT|06902||Full field digital,system,x-ray,mammographic|FUJI'S COMPUTED RADIOGRAPHY  MAMMOGRAPHY SUITE (FCRMS)|MUE|RA|||N|03/30/2005|07/10/2006|06M-0295|07/25/2006|APRL|APPROVAL FOR THE FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS).  THE FCRMS IS A SOFTWARE DEVICE THAT, IN CONJUNCTION WITH A SPECIFIED FUJI COMPUTED RADIOGRAPHY SYSTEM, FORMS THE FUJI COMPUTED RADIOGRAPHY FOR MAMMOGRAPHY (FCRM) DEVICE.  FCRM WITH A DEDICATED MAMMOGRAPHIC X-RAY MACHINE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER.  IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM BASED MAMMOGRAPHIC (SFM) SYSTEMS.  THE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY A QUALIFIED PHYSICIAN USING EITHER HARDCOPY FILM OR SOFTCOPY DISPLAY AT A WORKSTATION.
P050016||CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|||Y|03/30/2005|07/03/2007|07M-0286|07/20/2007|APPR|APPROVAL FOR THE CORMET HIP RESURFACING SYSTEM.  THE CORMET HIP RESURFACING SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD AND CEMENTLESS ACETABULAR COMPONENT.  THE DEVICE IS INTENDED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING CONDITIONS: 1) NON-INFLAMMATORY DEGENERATIVE ARTHRITIS SUCH AS OSTEOARTHRITIS AND AVASCULAR NECROSIS; 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.  THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING IPSILATERAL HIP JOINT REVISION.
P050017||Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|||N|04/15/2005|06/26/2006|06M-0294|07/26/2006|APPR|APPROVAL FOR THE ZILVER VASCULAR STENT.  THIS DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.  PATIENTS MUST BE SUITABLE FOR PTA AND STENT TREATMENT.
P050018||SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT SCORING BALLOON CATHETER|NWX|CV|||N|05/11/2005|01/08/2007|07M-0032|01/23/2007|APPR|APPROVAL FOR THE ANGIOSCULPT SCORING BALLOON CATHETER.  THE DEVICE IS INDICATED FOR THE TREATMENT OF HEMODYNAMICALLY SIGNIFICANT CORONARY ARTERY STENOSIS, INCLUDING IN-STENT RESTENOSIS AND COMPLEX TYPE C LESIONS, FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P050019||Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|||N|05/24/2005|10/23/2008|08M-0596|12/01/2008|APPR|APPROVAL FOR THE CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS.  THE DEVICE, USED INCONJUNCTION WITH THE BOSTON SCIENTIFIC EMBOLIC PROTECTION SYSTEM, IS INDICATED FOR THE TREATMENTOF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY DUE TO EITHER ANATOMIC OR COMORBID CONDITIONS WHO REQUIRE CAROTID REVASCULARIZATION IN THE TREATMENT OF IPSILATERAL ORBILATERAL CAROTID ARTERY DISEASE AND MEET THE CRITERIA OUTLINED BELOW:1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND > 50% STENOSIS OF THE COMMON, INTERNAL CAROTIDARTERY AND/OR THE BIFURCATION BY ULTRASOUND OR ANGIOGRAM, OR PATIENTS WITHOUT NEUROLOGICALSYMPTOMS AND > 80% STENOSIS OF THE COMMON, INTERNAL CAROTID ARTERY AND/OR THEBIFURCATION BY ULTRASOUND OR ANGIOGRAM, AND;2) PATIENTS WITH A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THETARGET LESION.
P050020||Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR|MDS|CH|||Y|06/08/2005|03/12/2008|08M-0207|04/01/2008|APWD|APPROVAL FOR THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM.  THE DEVICE IS INDICATED FOR THE FOLLOWING: THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS INDICATED FOR CONTINUALLY RECORDING INTERSTITIAL FLUID GLUCOSE LEVELS IN PEOPLE (AGES 18 AND OLDER) WITH DIABETES MELLITUS FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. READINGS AND ALARMS ABOUT GLUCOSE LEVELS FROM THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM ARE NOT INTENDED TO REPLACE TRADITIONAL BLOOD GLUCOSE MONITORING.  BEFORE ADJUSTING THERAPY FOR DIABETES MANAGEMENT BASED ON THE RESULTS AND ALARMS FROM THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM, TRADITIONAL BLOOD GLUCOSE TESTS MUST BE PERFORMED.  THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM PROVIDES A BUILT-IN BLOOD GLUCOSE METER TO CONFIRM THE CONTINUOUS GLUCOSE RESULT.  THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM PROVIDES REAL-TIME READINGS, GRAPHS, TRENDS AND GLUCOSE ALARMS DIRECTLY TO THE USER.  THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS INTENDED TO BE USED IN HOME SETTINGS TO AID PEOPLE WITH DIABETES IN PREDICTING AND DETECTING EPISODES OF HYPOGLYCEMIA AND HYPERGLYCEMIA AND IN CLINICAL SETTINGS TO AID HEALTHCARE PROFESSIONALS IN EVALUATING GLUCOSE CONTROL.  THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS AVAILABLE ONLY BY PRESCRIPTION.
P050021||BIOLITEC, INC.|515 SHAKER RD.||EAST LONGMEADOW|MA|01028||SYSTEM, LASER, PHOTODYNAMIC THERAPY|CERALAS I LASER|MVF|SU|||N|06/09/2005|12/20/2005|06M-0161|04/18/2006|APWD|APPROVAL FOR THE CERALAS I LASER SYSTEM AND CERALINK SLIT LAMP ADAPTER.  THE DEVICE IS INDICATED FOR THE PHOTOACTIVATION OF THE LIGHT ACTIVATED DRUG VISUDYNE (VERTEPORFIN FOR INJECTION) IN PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA, OR PRESUMED OCULAR HISTOPLASMOSIS.
P050022||SIEMENS MEDICAL SOLUTIONS USA, INC.|51 VALLEY STREAM PKWY.,|MAIL STOP E-51|MALVERN|PA|19355||Lung computed tomography system, computer-aided diagnosis|SYNGO LUNG CAD|NRR|RA|||N|06/30/2005|10/18/2006|06M-0456|11/08/2006|APCB|APPROVAL FOR THE SYNGO LUNG CAD SOFTWARE DEVICE.  THE DEVICE IS INDICATED TO ASSIST RADIOLOGISTS IN THE DETECTION OF SOLID PULMONARY NODULES DURING REVIEW OF MULTI-DETECTOR COMPUTED TOMOGRAPHY (MDCT) EXAMINATIONS OF THE CHEST.  THE SOFTWARE IS AN ADJUNCTIVE TOOL TO ALERT THE RADIOLOGIST TO REGIONS OF INTEREST (ROI) THAT MAY HAVE BEEN INITIALLY OVERLOOKED.  THE LUNG CAD SOFTWARE DEVICE IS INTENDED TO BE USED AS A SECOND READER AFTER THE RADIOLOGIST HAS COMPLETED HIS/HER INITIAL READ.
P050023||BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD|MRM|CV|||N|07/11/2005|08/10/2006|06M-0367|09/08/2006|APPR|APPROVAL FOR THE TUPOS LV/ATX CRT-D, KRONOS LV-T CRT-D, 505.U PROGRAMMER SOFTWARE FOR THE ICS 3000, A-K00.7.U PROGRAMMER SOFTWARE FOR THE EPR/TMS 1000PLUS AND COROX OTW STEROID LEAD.  THE TUPOS LV/ATX AND KRONOS LV-T CRT-DS ARE INDICATED FOR USE IN PATIENTS WITH ALL OF THE FOLLOWING CONDITIONS: 1) INDICATED FOR ICD THERAPY; 2) RECEIVING OPTIMIZED AND STABLE CONGESTIVE HEART FAILURE (CHF) DRUG THERAPY; 3) SYMPTOMATIC CHF (NYHA CLASS III/IV AND LVEF <=35%); AND 4) INTRAVENTRICULAR CONDUCTION DELAY (QRS DURATION >=130 MS).  THE TUPOS LV/ATX IS ALSO INDICATED FOR PATIENTS WHO, IN ADDITION TO AN INDICATION FOR A CRT-D DEVICE, HAVE ATRIAL TACHYARRHYTHMIAS OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  THE COROX OTW STEROID LEADS ARE INTENDED FOR IMPLANTATION VIA THE CORONARY VEINS TO PROVIDE LONG TERM CARDIAC PACING WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.
P050024||Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CRYOCOR CRYOABLATION SYSTEM|OAD|CV|||N|07/15/2005|08/01/2007|07M-0303|08/03/2007|APWD|APPROVAL FOR THE CRYOCOR CRYOABLATION SYSTEM.  THE DEVICE IS INDICATED FOR USE IN THE ABLATION OF ISTHMUS-DEPENDENT RIGHT ATRIAL FLUTTER IN PATIENTS 18 YEARS OF AGE OR OLDER.
P050025||BOSTON SCIENTIFIC|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CAROTID|ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM|NIM|CV|||N|07/15/2005|10/27/2006|06M-0459|11/13/2006|APPR|APPROVAL FOR THE ENDOTEX NEXSTENT. THIS DEVICE IS INDICATED FOR TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW:  1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY DUPLEX ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM, AND 2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4MM AND 9MM AT THE TARGET LESION AND A STENOSIS LESS THAN 30MM IN LENGTH.
P050026||VALEANT PHARMACEUTICALS LUXEMBOURG S.A.R.L.|208 VAL DES BONS MALADES||GRAND DUCHY OF LUXEMBOURG||L-212|2121|SYSTEM, LASER, PHOTODYNAMIC THERAPY|QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS|MVF|SU|||N|07/14/2005|04/04/2006|06M-0162|04/18/2006|APPR|APPROVAL FOR THE QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS.  THE DEVICE IS INDICATED FOR THE PHOTOACTIVATION OF THE LIGHT ACTIVATED DRUG VISUDYNE (VERTEPORFIN FOR INJECTION) IN PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA, OR PRESUMED OCULAR HYSTOPLASMOSIS.
P050027||KARL STORZ ENDOSCOPY-AMERICA, INC.|2151 E. GRAND AVE.||EL SEGUNDO|CA|90245||Light source system, diagnostic endoscopic|KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM|OAY|GU|||N|07/31/2005|05/28/2010|10M-0294|06/14/2010|APPR|APPROVAL FOR THE KARL STORZPHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM. THE KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHTC (PDD) SYSTEM IN COMBINATION WITH THE OPTICAL IMAGING DRUG CYSVIEW(HEXAMINOLEVULINATE HYDROCHLORIDE) FOR INTRAVESICAL SOLUTION IS INDICATED FOR PHOTODYNAMIC BLUELIGHT CYSTOSCOPY, AS AN ADJUNCT TO WHITE LIGHT CYSTOSCOPY FOR THE DETECTION OF NON-MUSCLE INVASIVEPAPILLARY CANCER OF THE BLADDER IN PATIENTS SUSPECTED OR KNOWN TO HAVE THE LESION ON THE BASIS OF A PRIOR CYSTOSCOPY.
P050028||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST|MKT|MI|||N|08/02/2005|09/04/2008|08M-0501|09/11/2008|APPR|APPROVAL FOR COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM.  THIS DEVICE IS INDICATED FOR: THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM OR PLASMA (EDTA), USING THE HIGH PURE VIRAL NUCLEIC ACID KIT FOR MANUAL SPECIMEN PREPARATION AND THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION.  THE TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY.  THE ASSAY CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT.  THE RESULTS FROM THE COBAS TAQMAN HBV TEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.  ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH ADEFOVIR DIPIVOXIL.  ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HBV INFECTION HAS NOT BEEN ESTABLISHED.  THE COBAS TAQMAN HBV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR BLOOD OR BLOOD PRODUCTS FOR THE PRESENCE OF HBV OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV INFECTION.
P050029||STEREOTAXIS, INC.|4320 FOREST PARK AVENUE|SUITE 100|ST. LOUIS|MO|63108||Cardiac ablation percutaneous catheter|HELIOS II ABLATION CATHETER|LPB|CV|||N|08/23/2005|10/10/2008|08M-0601|12/01/2008|APPR|APPROVAL FOR THE HELIOS II ABLATION CATHETER.  THE HELIOS II ABLATION CATHETER IS INTENDED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING, DELIVERING DIAGNOSTIC PACING STIMULI, AND FOR THE CREATION OF ENDOCARDIAL LESIONS TO TREAT PATIENTS WITH SUPRAVENTRICULAR (SVT) TACHYCARDIAS.IT IS INTENDED TO ELIMINATE ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) IN PATIENTS WITH OVERT OR CONCEALED ACCESSORY PATHWAYS, TO ELIMINATE AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT), AND TO CREATE COMPLETE AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO ATRIAL FIBRILLATION.THE HELIOS II ABLATION CATHETER IS INTENDED FOR USE WITH THE BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR VIA A BIOSENSE WEBSTER CABLE MODEL C6-MR10/MSTK-S (6 FOOT) OR C10-MR10/MSTK-S (10 FOOT).  THE HELIOS II ABLATION CATHETER IS FOR USE ONLY WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND IS COMPATIBLE WITH THE CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS).
P050031||PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact, orthokeratology, overnight|PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY|NUU|OP|||N|08/26/2005|11/16/2006|06M-0473|11/27/2006|APPR|APPROVAL FOR THE PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY.  THE LENSES ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES.  THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 6.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.75 DIOPTERS.  THE LENSES MAY BE DISINFECTED USING ONLY A CHEMICAL DISINFECTION SYSTEM.  NOTE: TO MAINTAIN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE.  FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.
P050033||Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|||N|09/02/2005|12/20/2006|06M-0531|12/26/2006|APPR|APPROVAL FOR THE COSMETIC TISSUE AUGMENTATION PRODUCT.  THIS DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
P050034||VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE (IMT)|NCJ|OP|||Y|09/09/2005|07/01/2010|10M-0361|07/07/2010|APPR|APPROVAL FOR THE IMT MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X. THIS DEVICE IS INDICATED FOR MONOCULARIMPLANTATION TO IMPROVE VISION IN PATIENTS GREATER THAN OR EQUAL TO 75 YEARS OF AGE WITH STABLESEVERE TO PROFOUND VISION IMPAIRMENT (BEST CORRECTED DISTANCE VISUAL ACUITY 20/160 TO 20/800) CAUSED BY BILATERAL CENTRAL SCOTOMAS ASSOCIATED WITH END-STAGE AGE-RELATED MACULAR DEGENERATION.  PATIENTS MUST:1) HAVE RETINAL FINDINGS OF GEOGRAPHIC ATROPHY OR DISCIFORM SCAR WITH FOVEAL INVOLVEMENT, ASDETERMINED BY FLUORESCEIN ANGIOGRAPHY;2) HAVE EVIDENCE OF VISUALLY SIGNIFICANT CATARACT (> GRADE 2);3) AGREE TO UNDERGO PRE-SURGERY TRAINING AND ASSESSMENT (TYPICALLY 2 TO 4 SESSIONS) WITH LOWVISION SPECIALISTS (OPTOMETRIST OR OCCUPATIONAL THERAPIST) IN THE USE OF AN EXTERNALTELESCOPE SUFFICIENT FOR PATIENT ASSESSMENT AND FOR THE PATIENT TO MAKE AN INFORMEDDECISION;4) ACHIEVE AT LEAST A 5-LETTER IMPROVEMENT ON THE ETDRS CHART WITH AN EXTERNAL TELESCOPE;5) HAVE ADEQUATE PERIPHERAL VISION IN THE EYE NOT SCHEDULED FOR SURGERY; AND6) AGREE TO PARTICIPATE IN POSTOPERATIVE VISUAL TRAINING WITH A LOW VISION SPECIALIST.
P050037||MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 1.3CC AND 0.3CC|LMH|SU|||N|09/29/2005|12/22/2006|07M-0006|01/17/2007|APPR|APPROVAL FOR RADIESSE.  THIS DEVICE IS INDICATED FOR SUBDERMAL IMPLANTATION FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.
P050038||C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|||N|09/30/2005|09/26/2006|06M-0396|10/03/2006|APPR|APPROVAL FOR THE ARISTA AH ABSORBABLE HEMOSTAT.  THE DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P050039||EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|NOVATION CERAMIC ARTICULATION HIP SYSTEM|MRA|OR|||N|10/27/2005|07/05/2007|07M-0287|07/20/2007|APPR|APPROVAL FOR THE NOVATION CERAMIC ARTICULATION HIP SYSTEM.  THIS DEVICE IS INDICATED FOR PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.
P050040||INVITROGEN CORPORATION|3175 STALEY RD.||GRAND ISLAND|NY|14072||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|SPOT-LIGHT HER2 CISH KIT|NYQ|PA|||N|11/03/2005|07/01/2008|08M-0437|07/31/2008|APWD|APPROVAL FOR SPOT-LIGHT HER2 CISH KIT.  THIS DEVICE IS INDICATED FOR:  THE SPOT-LIGHT HER2 CISH KIT IS INTENDED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CARCINOMA TISSUE SECTIONS USING CHROMOGENIC IN SITU HYBRIDIZATION (CISH) AND BRIGHTFIELD MICROSCOPY. THIS TEST SHOULD BE PERFORMED IN A HISTOPATHOLOGY LABORATORY. THE SPOT-LIGHT HER2 CISH KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. THE ASSAY RESULTS ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGICAL INFORMATION CURRENTLY BEING USED AS PART OF THE MANAGEMENT OF BREAST CANCER PATIENTS. INTERPRETATION OF TEST RESULTS MUST BE MADE WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY BY A QUALIFIED PATHOLOGIST.
P050042||ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL|MZO|MI|||N|11/23/2005|06/07/2006|06M-0389|09/26/2006|APPR|APPROVAL FOR THE ABBOTT ARCHITECT ANTI-HCV.  THIS DEVICE IS INDICATED FOR: THE ARCHITECT ANTI-HCV ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).  ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION.  THE ARCHITECT ANTI-HCV CALIBRATOR IS USED FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).  THE ARCHITECT ANTI-HCV CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE ARCHITECT I SYSTEM WITH THE ARCHITECT ANTI-HCV REAGENT KIT.  REFER TO THE ARCHITECT ANTI-HCV ASSAY REAGENT PACKAGE INSERT FOR THE FULL LISTING OF INFORMATION REGARDING THE ASSAY.  THE ARCHITECT ANTI-HCV CONTROLS ARE USED TO PROVIDE AN ESTIMATION OF TEST PRECISION AND TO DETECT SYSTEMATIC ANALYTICAL DEVIATIONS OF THE ARCHITECT I SYSTEM (REAGENTS, CALIBRATOR, AND INSTRUMENT (WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).  THE ARCHITECT ANTI-HCV CONTROLS HAVE BEEN VALIDATED FOR USE ONLY ON THE ARCHITECT I SYSTEM WITH THE ARCHITECT ANTI-HCV REAGENT KIT.
P050043||MORRIS INNOVATIVE RESEARCH INC|907 W.SECOND ST||BLOOMINGTON|IN|47403||Device, hemostasis, vascular|FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH|MGB|CV|||N|11/23/2005|08/20/2007|07M-0344|09/18/2007|APPR|APPROVAL FOR THE FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5, 6, AND 8 FRENCH.  THE DEVICE IS INDICATED AS FOLLOWS: THE FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE IS INTENDED FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES.  THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5, 6, OR 8 FRENCH PROCEDURAL SHEATHS.
P050044||STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Absorbable collagen hemostatic agent with thrombin|VITAGEL RT3 SUTGICAL HEMOSTAT|PMX|SU|||N|11/30/2005|06/16/2006|06M-0293|07/26/2006|APPR|APPROVAL FOR THE VITAGEL SURGICAL HEMOSTAT.  THE DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P050045||DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion|DAKO TOP2A FISH PHARMDX KIT|NXG|PA|||N|11/30/2005|01/11/2008|08M-0182|03/20/2008|APPR|APPROVAL FOR THE TOP2A FISH PHARMDX KIT.  THE DEVICE IS INDICATED FOR: TOP2A FISH PHARMDX KIT IS DESIGNED TO DETECT AMPLIFICATIONS AND DELETIONS (COPY NUMBER CHANGES) OF THE TOP2A GENE USING FLUORESCENCE IN SITU HYBRIDIZATION (FISH) TECHNIQUE ON FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS.  DELETIONS AND AMPLIFICATIONS OF THE TOP2A GENE SERVE AS A MARKER FOR POOR PROGNOSIS IN HIGH-RISK BREAST CANCER PATIENTS.  RESULTS FROM THE TOP2A FISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO EXISTING CLINICAL AND PATHOLOGICAL INFORMATION.
P050046||GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE LEAD SYSTEM|OJX|CV|||N|10/14/2005|04/13/2007|07M-0154|04/19/2007|APPR|APPROVAL FOR THE ACUITY STEERABLE LEAD MODELS 4554, 4555, AND 4556. THE GUIDANT ACUITY STEERABLE IS-1 CORONARY VENOUS, STEROID-ELUTING, DUAL-ELECTRODE PACE/SENSE LEADS ARE TRANSVENOUS LEADS INTENDED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.  EXTENDED BIPOLAR PACING AND SENSING IS AVAILABLE USING ACUITY STEERABLE WITH AN RV PACE/SENSE/DEFIBRILLATION LEAD OR A BIPOLAR RV PACE/SENSE LEAD.
P050047||Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS|LMH|SU|||N|12/05/2005|06/02/2006|06M-0235|06/29/2006|APPR|APPROVAL FOR THE JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS.  THE DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
P050048||BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|MONOLISA ANTI-HBS EIA|LOM|MI|||N|12/05/2005|08/25/2006|07M-0151|04/19/2007|APPR|APPROVAL FOR THE MONOLISA ANTI-HBS EIA AND THE MONOLISA ANTI-HBS CALIBRATOR KIT.  THE DEVICES ARE INDICATED FOR: THE MONOLISA ANTI-HBS EIA IS A QUALITATIVE AND QUANTITATIVE ENZYME IMMUNOASSAY FOR THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND EDTA OR CITRATED PLASMA.  THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.  THE MONOLISA ANTI-HBS CALIBRATOR KIT IS INTENDED FOR QUANTITATIVE DETERMINATION OF ANTI-HBS IN HUMAN SERUM AND EDTA OR CITRATED PLASMA.  THE MONOLISA ANTI-HBS CALIBRATOR KIT IS TO BE USED ONLY WITH THE MONOLISA ANTI-HBS EIA.
P050049||ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS|LOM|MI|||N|12/06/2005|06/01/2006|07M-0174|05/03/2007|APWD|APPROVAL FOR THE ABBOTT AXSYM HBSAG ASSAY, WHICH IS INDICATED FOR: AXSYM HBSAG: AXSYM HBSAG IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN NEONATAL SERUM, AND ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES).  THE ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.  THE ASSAY MAY BE USED TO TEST FOR HBV INFECTION IN PREGNANT WOMEN.  AXSYM HBSAG CONFIRMATORY: AXSYM HBSAG CONFIRMATORY IN S MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN NEONATAL SERUM, AND ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES).  THE ASSAY IS USED FOR CONFIRMATION OF SAMPLES FOUND TO BE REPEATEDLY REACTIVE BY THE AXSYM HBSAG ASSAY.  THE ASSAY MAY BE USED TO CONFIRM HEPATITIS B VIRUS (HBV) INFECTION IN PREGNANT WOMAN.  AXSYM HBSAG CONTROLS: THE AXSYM HBSAG POSITIVE AND NEGATIVE CONTROLS ARE FOR USE IN MONITORING THE PERFORMANCE OF THE AXSYM HBSAG REAGENT KIT AND THE AXSYM HBSAG CONFIRMATORY KIT.  THE PERFORMANCE OF THE AXSYM HBSAG CONTROLS HAVE NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAYS.
P050050||STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)|NTG|OR|||Y|12/07/2005|05/27/2009|11M-0323|05/10/2011|APPR|APPROVAL FOR THE STAR ANKLE.  THE DEVICE IS INDICATED FOR USE AS A NON-CEMENTED IMPLANT TO REPLACE A PAINFUL ARTHRITIC ANKLE JOINT DUE TO OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS OR RHEUMATOID ARTHRITIS.
P050051||ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT AUSAB|LOM|MI|||N|12/09/2005|06/01/2006|06M-0321|08/17/2006|APPR|APPROVAL FOR THE ARCHITECT AUSAB REAGENT KIT, WHICH IS INDICATED FOR: ARCHITECT AUSAB REAGENT KIT: THE ARCHITECT AUSAB ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM.  IT IS INTENDED FOR QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE FOLLOWING HEPATITIS B VIRUS (HBV) VACCINATION, DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.  ARCHITECT AUSAB CALIBRATORS: THE ARCHITECT AUSAB CALIBRATORS ARE USED TO CALIBRATE THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT.  THE PERFORMANCE OF THE ARCHITECT AUSAB CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS. ARCHITECT AUSAB CONTROLS: THE ARCHITECT AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT.  THE PERFORMANCE OF THE ARCHITECT AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.
P050052||MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|||N|12/22/2005|12/22/2006|07M-0007|01/17/2007|APPR|APPROVAL FOR RADIESSE.  THIS DEVICE IS INDICATED FOR SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS.
P050053||MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|||N|12/30/2005|03/09/2007|07M-0084|03/13/2007|APPR|APPROVAL FOR THE INFUSE BONE GRAFT.  THE DEVICE IS INDICATED AS AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS.
P060001||MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS|NIM|CV|||N|01/09/2006|01/24/2007|07M-0049|02/09/2007|APPR|APPROVAL FOR THE PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS. THIS DEVICE IS INDICATED FOR USED IN CONJUNCTION WITH EV3 EMBOLIC PROTECTION DEVICES, ARE INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE PERCUTANEOUS CAROTID REVASCULARIZATION AND MEET THE FOLLOWING CRITERIA:1) PATIENTS WITH CAROTID ARTERY STENOSIS (>= 50% FOR SYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY OR >= 80% FOR ASYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY) OF THE COMMON OR INTERNAL CAROTID ARTERY, AND2)  PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.5 MM AND 9.5 MM AT THE TARGET LESION.
P060002||BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|||N|01/17/2006|07/23/2007|07M-0298|08/01/2007|APPR|APPROVAL FOR THE FLAIR ENDOVASCULAR STENT GRAFT.  THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF STENOSES AT THE VENOUS ANASTOMOSIS OF EPTFE OR OTHER SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFTS.
P060003||ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM, AUSAB|LOM|MI|||N|02/10/2006|08/07/2006|07M-0161|04/30/2007|APWD|APPROVAL FOR THE AXSYM AUSAB ASSAY.  THE DEVICE IS INDICATED FOR: AXSYM AUSAB REAGENT PACK IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN SODIUM HEPARIN).  THE ASSAY IS USED FOR THE QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE TO HEPATITIS B VIRUS (HBV) VACCINATION FOR THE DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.  THE AXSYM AUSAB STANDARD CALIBRATORS ARE USED FOR THE CALIBRATION OF THE AXSYM SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE AXSYM AUSAB REAGENT PACK.  THE PERFORMANCE OF THE AXSYM AUSAB STANDARD CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.  THE AXSYM AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE AXSYM SYSTEM (REAGENT, CALIBRATORS, AND INSTRUMENT) WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) WHEN USING THE AXSYM AUSAB REAGENT PACK.  THE PERFORMANCE OF THE AXSYM AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.
P060004||Carl Zeiss Meditec, Inc.|5160 Hacienda Drive||Dublin|CA|94568||Excimer laser system|MEL 80 EXCIMER LASER SYSTEM|LZS|OP|||N|02/14/2006|08/11/2006|06M-0342|08/25/2006|APPR|APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM.  THE DEVICE USES AN OPTICAL ZONE OF 6.0 TO 7.0 MM IN DIAMETER AND A TRANSITION ZONE OF 1.7 TO 1.9 MM FOR TOTAL ABLATION DIAMETER OF 7.7 TO 8.9 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIA OF LESS THAN OR EQUAL TO -7.0 D, WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF LESS THAN OR EQUAL TO -3.0 D, WITH A MAXIMUM MRSE OF -7.00 D; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; 3) WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION OVER THE PAST YEAR AS DEMONSTRATED BY CHANGE IN SPHERE AND CYLINDER OF <=0.5D.
P060005||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED|GLYN RHONWY. LLANBERIS|CAERNARFON|GWYNEDD, LL55||4EL||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS|MTG|IM|||N|02/14/2006|05/11/2007|07M-0409|11/09/2007|APPR|APPROVAL FOR THE IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAY.  THESE DEVICES ARE INDICATED FOR:  THE IMMULITE / IMMULITE 1000 FREE PSA ASSAY IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE / IMMULITE 1000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE-SPECIFIC ANTIGEN (PSA) NOT BOUND TO ALPHA 1-ANTICHYMOTRYPSIN OR OTHER BINDING PROTEINS (UNCOMPLEXED) IN HUMAN SERUM (INCLUDING SERUM COLLECTED IN SERUM GLASS, SERUM PLASTIC AN SERUM GEL SEPARATOR TUBES).  MEASUREMENT OF FREE PSA IS USED IN CONJUNCTION WITH IMMULITE / IMMULITE 1000 TOTAL PSA TO DETERMINE A RATIO OF FREE PSA TO TOTAL PSA (PERCENT FREE PSA).  THE PERCENT FREE PSA IS USED AS AN AID IN DISCRIMINATING PROSTATE CANCER FROM BENIGN DISEASE IN MEN 50 YEARS OR OLDER WITH IMMULITE / IMMULITE 1000 TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DIGITAL RECTAL EXAM (DRE) FINDINGS NOT SUSPICIOUS OF CANCER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THE IMMULITE 2000 FREE PSA ASSAY IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE-SPECIFIC ANTIGEN (PSA) NOT BOUND TO ALPHA 1-ANTICHYMOTRYPSIN OR OTHER BINDING PROTEINS (UNCOMPLEXED) IN HUMAN SERUM (INCLUDING SERUM COLLECTED IN SERUM GLASS, SERUM PLASTIC AN SERUM GEL SEPARATOR TUBES).  MEASUREMENT OF FREE PSA IS USED IN CONJUNCTION WITH IMMULITE 2000 TOTAL PSA TO DETERMINE A RATIO OF FREE PSA TO TOTAL PSA (PERCENT FREE PSA).  THE PERCENT FREE PSA IS USED AS AN AID IN DISCRIMINATING PROSTATE CANCER FROM BENIGN DISEASE IN MEN 50 YEARS OR OLDER WITH IMMULITE 2000 TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DIGITAL RECTAL EXAM (DRE) FINDINGS NOT SUSPICIOUS OF CANCER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.
P060006||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|||N|02/21/2006|12/11/2008|08M-0646|12/19/2008|APPR|APPROVAL FOR THE BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM.  THE DEVICE IS INDICATED AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A SINGLE DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESION (<=15 MM IN LENGTH) OF THE RENAL ARTERY, LOCATED WITHIN 5 MM OF THE OPACIFIED AORTIC LUMEN, WITH A REFERENCE VESSEL DIAMETER OF 4.0 ¿ 7.0 MM TO ASSIST IN THE MAINTENANCE OF VESSEL PATENCY.
P060007||Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG REAGENT KIT, CALIBRATORS,  CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT|LOM|MI|||N|02/24/2006|09/07/2006|07M-0152|04/29/2007|APWD|APPROVAL FOR THE ARCHITECT HBSAG REAGENTS, ARCHITECT HBSAG CALIBRATORS, ARCHITECT HBSAG CONTROLS, ARCHITECT HBSAG CONFIRMATORY REAGENTS, AND ARCHITECT HBSAG CONFIRMATORY MANUAL DILUENT.  THE ARCHITECT HBSAG ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA). THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT FEMALES TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION.  THE ARCHITECT HBSAG CALIBRATORS ARE USED FOR CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) USING THE ARCHITECT HBSAG AND HBSAG CONFIRMATORY REAGENT KITS. THE PERFORMANCE OF THE ARCHITECT HBSAG CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAYS.  (CONTINUED...)
P060008||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|||N|03/08/2006|10/10/2008|08M-0593|11/14/2008|APPR|APPROVAL FOR THE TAXUS LIBERTÉ PACLITAXEL-ELUTING CORONARY STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <= 28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >= 2.5 MM TO <= 4.0 MM IN DIAMETER.
P060009||ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT: 09VB BLDG: AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS|LOM|MI|||N|03/10/2006|08/25/2006|07M-0160|04/30/2007|APWD|APPROVAL FOR THE ABBOTT AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS.  THESE DEVICES ARE INDICATED FOR: THEAXSYM CORE-M 2.0 IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE IN VITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN (IGM ANTI-HBC) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES). THE ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.THE AXSYM CORE-M 2.0 CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE AXSYM SYSTEM (REAGENT AND INSTRUMENT) WHEN USED FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN (IGM ANTI HBC) WHEN USING THE AXSYM CORE-M 2.0 REAGENT PACK. THE PERFORMANCE OF THE AXSYM CORE-M 2.0 CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC ASSAYS.
P060010||SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|||N|03/14/2006|12/14/2006|06M-0529|12/26/2006|APPR|APPROVAL FOR THE SPANNER TEMPORARY PROSTATIC STENT.  THE DEVICE IS INTENDED FOR TEMPORARY USE (UP TO 30 DAYS) TO MAINTAIN URINE FLOW AND ALLOW VOLUNTARY URINATION IN PATIENTS FOLLOWING MINIMALLY INVASIVE TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) AND AFTER INITIAL POST-TREATMENT CATHETERIZATION.
P060011||RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7||intraocular lens|C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)|HQL|OP|||N|03/15/2006|05/03/2007|07M-0189|05/11/2007|APPR|APPROVAL FOR THE C-FLEX MODEL 570C INTRAOCULAR LENS (IOL).  THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICA-TION.  THE LENS IS INTENDED TO BE PLACE IN THE CAPSULAR BAG.
P060012||ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS|LOM|MI|||N|03/24/2006|09/08/2006|07M-0153|04/19/2007|APWD|APPROVAL FOR THE AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS. THIS DEVICE IS INDICATED FOR: THE AXSYM CORE 2.0 IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES (IGG AND IGM) TO HEPATITIS B VIRUS CORE ANTIGEN (ANTI HBC) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES CONTAINING LITHIUM HEPARIN). THE ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF ACUTE, CHRONIC, OR RESOLVED HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.  THE THE AXSYM CORE 2.0 CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE AXSYM SYSTEM (REAGENT AND INSTRUMENT) WHEN USED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B VIRUS CORE ANTIGEN (ANTI HBC) WHEN USING THE AXSYM CORE 2.0 REAGENT KIT. THE PERFORMANCE OF THE AXSYM CORE 2.0 CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC ASSAYS.
P060017||JANSSEN DIAGNOSTICS|700 US HIGHWAY RTE 202 SOUTH||RARITAN|NJ|08869||Rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection|GENESEARCH BREAST LYMPH NODE(BLN) ASSAY|OCB|PA|||N|05/01/2006|07/16/2007|07M-0413|11/09/2007|APWD|APPROVAL FOR THE GENESEARCH BREAST LYMPH NODE (BLN) ASSAY. THIS DEVICE IS INDICATED AS A QUALITATIVE, IN VITRO DIAGNOSTIC TEST FOR THE RAPID DETECTION OF GREATER THAN 0.2 MM METASTASES IN NODAL TISSUE REMOVED FROM SENTINEL LYMPH NODE BIOPSIES OF BREAST CANCER PATIENTS. RESULTS FROM THE ASSAY CAN BE USED TO GUIDE THE INTRA OPERATIVE OR POST-OPERATIVE DECISION TO REMOVE ADDITIONAL LYMPH NODES. POST-OPERATIVE HISTOLOGICAL EVALUATION OF PERMANENT SECTIONS OF THE TISSUE SPECIMEN, IN ACCORDANCE WITH USUAL DIAGNOSTIC PRACTICE AND USING THE VERIDEX LYMPH NODE CUTTING SCHEME, IS REQUIRED.
P060018||MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE CERVICAL DISC SYSTEM|MJO|OR|||Y|05/19/2006|07/16/2007|07M-0289|07/20/2007|APPR|APPROVAL FOR THE PRESTIGE CERVICAL DISC SYSTEM. THIS DEVICE IS INDICATED FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY.  THE PRESTIGE DEVICE IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH.  INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY SHOULD PRESENT WITH AT LEAST ONE OF THE FOLLOWING ITEMS PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION WHICH IS DOCUMENTED BY PATIENT HISTORY (E.G., PAIN [NECK AND/OR ARM PAIN], FUNCTIONAL DEFICIT, AND/OR NEUROLOGICAL DEFICIT), AND RADIOGRAPHIC STUDIES (E.G., CT, MRI, X-RAYS, ETC.): 1) HERNIATED DISC, AND/OR 2) OSTEOPHYTE FORMATION.
P060019||IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF|OAD|CV|||N|05/30/2006|03/16/2007|07M-0108|03/26/2007|APPR|APPROVAL FOR THE THERAPY COOL PATH ABLATION CATHETER AND IBI 1500T9 RF ABLATION GENERATOR.  THE THERAPY COOL PATH ABLATION CATHETER IS INTENDED FOR USE WITH A COMPATIBLE EXTERNAL INFUSION PUMP AND THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS.  THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.  THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ST. JUDE MEDICAL TEMPERATURE CONTROLLED ABLATION CATHETERS FOR CREATING ENDOCARDIAL LESIONS TO TREAT CARDIAC ARRHYTHMIAS (I.E. SUPRAVENTRICULAR TACHYCARDIAS, AND ATRIAL FLUTTER).  THE GENERATOR IS INTERNALLY LIMITED TO 50 WATTS WHEN USED WITH THE THERAPY COOL PATH CATHETERS.  A COMPATIBLE EXTERNAL INFUSION PUMP MUST BE CONNECTED WHEN USED WITH THERAPY COOL PATH CATHETERS.
P060022||Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT|HQL|OP|||N|06/29/2006|09/05/2008|08M-0515|09/19/2008|APPR|APPROVAL FOR THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL: AKREOS ADVANCED OPTICS ASPHERIC LENS, AO60.  THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFI-CATION.  THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P060023||Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|BRYAN CERVICAL DISC PROSTHESIS|MJO|OR|||N|06/29/2006|05/12/2009|09M-0243|05/27/2009|APPR|APPROVAL FOR THE BRYAN CERVICAL DISC.  THE DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY.THE BRYAN DEVICE IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. INTRACTABLE RADICULOPATHYAND/OR MYELOPATHY IS DEFINED AS ANY COMBINATION OF THE FOLLOWING: DISC HERNIATION WITHRADICULOPATHY. SPONDYLOTIC RADICULOPATHY, DISC HERNIATION WITH MYELOPATHY, OR SPONDYLOTICMYELOPATHY RESULTING IN IMPAIRED FUNCTION AND AT LEAST ONE CLINICAL NEUROLOGICAL SIGN ASSOCIATEDWITH THE CERVICAL LEVEL TO BE TREATED, AND NECESSITATING SURGERY AS DEMONSTRATED USING COMPUTEDTOMOGRAPHY (CT), MYELOGRAPHY AND CT, AND/OR MAGNETIC RESONANCE IMAGING (MR1). PATIENTSRECEIVING THE BRYAN CERVICAL DISC SHOULD HAVE FAILED AT LEAST SIX WEEKS OF NON-OPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE BRYAN CERVICAL DISC.
P060025||MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|ATS 3F AORTIC BIOPROSTHESIS|LWR|CV|||N|09/27/2006|10/30/2008|08M-0594|11/14/2008|APPR|APPROVAL FOR THE ATS 3F AORTIC BIOPROSTHESIS, MODEL 1000 (SIZES 21, 23, 25, 27 AND 29 MM).  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P060027||SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT SYSTEM|NIK|CV|||N|10/02/2006|05/15/2008|08M-0426|07/28/2008|APPR|APPROVAL FOR THE OVATIO CRT-D SYSTEM. THE OVATIO CRT-D IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING ARRHYTHMIAS. THE DEVICE IS ALSO INDICATED FOR THE REDUCTION OF HEART FAILURE SYMPTOMS IN MEDICALLY OPTIMIZED NYHA FUNCTIONAL CLASS III AND IV PATIENTS WITH LEFT VENTRICULAR EJECTION FRACTION OF 35% OR LESS, AND A QRS DURATION OF 150 MS OR LONGER. SITUS OTW LV LEAD IS DESIGNED TO PACE THE LEFT VENTRICLE THROUGH A CORONARY VEIN. IT IS INTENDED TO BE USED IN CONJUNCTION WITH ELA MEDICAL CARDIAC SYNCHRONIZATION THERAPY PULSE GENERATORS.
P060028||MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|||N|10/02/2006|06/14/2013|13M-0738|06/19/2013|APPR|APPROVAL FOR THEMEMORYSHAPE BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR FEMALES FOR THE FOLLOWING USES(PROCEDURES):1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD. BREAST AUGMENTATION INCLUDES PRIMARYBREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY.  2) BREAST RECONSTRUCTION. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACEBREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY. BREAST RECONSTRUCTION ALSO INCLUDES REVISIONSURGERY TO CORRECT OR IMPROVE THE RESULTS OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
P060029||ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Sealant,polymerizing|ETHICON OMNEX SURGICAL SEALANT|NBE|CV|||N|10/26/2006|06/03/2010|10M-0285|06/11/2010|APPR|APPROVAL FOR THE ETHICON OMNEX SURGICAL SEALANT.  THE DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
P060030||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|||N|10/27/2006|10/30/2008|09M-0033|01/27/2009|APPR|APPROVAL FOR THE COBASAMPLIPREP/COBAS TAQMAN HCV TEST. THIS DEVICE IS AN IN VITRO NUCLEIC ACID AMPLIFICATION LESTFOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA IN HUMAN PLASMA OR SERUM OF HCV-INFECTEDINDIVIDUALS USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THECOBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION ANDDETECTION. SPECIMENS CONTAINING HCV GENOTYPES 1 - 6 HAVE BEEN VALIDATED FOR QUANTITATION INTHE ASSAY.  THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST IS INTENDED FOR USE AS AN AID IN THEMANAGEMENT OF HCV-INFECTED INDIVIDUALS UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY MEASURESHCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND CAN BE UTILIZED TO PREDICT SUSTAINED ANDNON-SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY. THE RESULTS FROM THE COBASAMPIPREP/COBAS TAQMAN HCV TEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAY'S PREDICTIVE VALUE WHEN OTHER THERAPIES ARE USED. ASSAY PERFORMANCE FOR DETERMINING THE SLATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED."
P060031||Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC EIA|LOM|MI|||N|10/30/2006|04/27/2007|07M-0467|12/04/2007|APPR|APPROVAL FOR THE BIO-RAD MONOLISA ANTI-HBC EIA.  THE DEVICE IS INDICATED FOR:  THE MONOLISA ANTI-HBC EIA IS AN ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES (IGG/IGM) TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, SODIUM CITRATE, ACD (ACID CITRATE DEXTROSE), LITHIUM HEPARIN AND SODIUM HEPARIN).  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKETS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.
P060033||MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|||N|11/20/2006|02/01/2008|08M-0109|02/12/2008|APWD|APPROVAL FOR THE ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT ON THE OVER-THE-WIRE (OTW), RAPID EXCHANGE (RX), OR MULTI-EXCHANGE II (MX2) STENT DELIVERY SYSTEMS.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH <= 27 MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSELL DIAMETERS OF >= 25 MM TO <= 3.5 MM.
P060034||Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO RAD MONOLISA ANTI-HBC IGM EIA|LOM|MI|||N|11/22/2006|05/31/2007|07M-0254|06/28/2007|APPR|APPROVAL FOR THE BIO-RAD MONOLISA ANTI-HBC IGM EIA.  THE DEVICE IS INDICATED FOR:  THE BIO-RAD MONOLISA ANTI-HBC IGM EIA IS AN ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, SODIUM CITRATE, ACD [ACID CITRATE DEXTROSE], LITHIUM HEPARIN AND SODIUM HEPARIN).  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.
P060035||Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS|LOM|MI|||N|12/01/2006|11/06/2007|07M-0447|11/19/2007|APPR|APPROVAL FOR THE ARCHITECT CORE-M REAGENT KITARCHITECT CORE-M CALIBRATORS ANDARCHITECT CORE-M CONTROLS.  THE DEVICES IS INDICTED FOR: THE ARCHITECT CORE-M ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM OR PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. A TEST FOR IGM ANTI-HBC IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.  THE ARCHITECT CORE-M CALIBRATORS ARE USED FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) USING THE ARCHITECT CORE-M REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE-M CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER IGM ANTI-HBC ASSAYS. THE ARCHITECT CORE-M CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN ADULT SERUM AND PLASMA WHEN USING THE ARCHITECT CORE-M REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE-M CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER IGM ANTI-HBC ASSAYS.
P060037||ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM|NJL|OR|||N|12/18/2006|12/10/2007|08M-0522|09/26/2008|APPR|APPROVAL FOR THE ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES.  THESE DEVICES ARE INDICATED FOR PATIENTS WITH SEVERE KNEE PAIN AND DISABILITY DUE TO OSTEOARTHRITIS; PRIMARY AND SECONDARY TRAUMATIC ARTHRITIS; AVASCULAR NECROSIS OF THE FEMORAL CONDYLE; OR MODERATE VALGUS, VARUS, OR FLEXION DEFORMITIES (I.E., VALGUS/VARUS DEFORMITY OF <=15 DEGREES, FIXED FLEXION DEFORMITY OF <=10 DEGREES).  THIS DEVICE IS INTENDED FOR CEMENTED USE ONLY.
P060038||LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|||N|12/18/2006|10/23/2007|07M-0410|11/09/2007|APPR|APPROVAL FOR THE MITROFLOW AORTIC PERICARDIAL HEART VALVE, SIZES 19, 21, 23, 25, AND 27 MM.  THE DEVICE IS INTENDED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P060039||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN STARFIX MODEL 4195 LEAD|OJX|CV|||N|12/27/2006|06/13/2008|08M-0478|08/27/2008|APPR|APPROVAL FOR THE ATTAIN STARFIX MODEL 4195 LEAD.  THE ATTAIN STARFIX MODEL 4195 STEROID ELUTING, TRANSVENOUS LEAD WITH DEPLOYABLE LOBE FIXATION IS INTENDED FOR CHRONIC PACING AND SENSING OF THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE CARDIAC DEFIBRILLATOR.
P070001||SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC TM-C TOTAL DISC REPLACEMENT|MJO|OR|||N|01/03/2007|12/17/2007|08M-0013|01/10/2008|APPR|APPROVAL FOR THE PRODISC-C TOTAL DISC REPLACEMENT.  THE DEVICE IS INDICATED FOR SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE SYMPTOMATIC CERVICAL DISC DISEASE (SCDD).  SYMPTOMATIC CERVICAL DISC DISEASE IS DEFINED AS NECK OR ARM (RADICULAR) PAIN AND/OR A FUNCTIONAL/NEUROLOGICAL DEFICIT WITH AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY IMAGING (CT, MRI, OR X-RAYS):  HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR LOSS OF DISC HEIGHT.  THE PRODISC-C TOTAL DISC REPLACEMENT IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH.  PATIENTS RECEIVING THE PRODISC-C TOTAL DISC REPLACEMENT SHOULD HAVE FAILED AT LEAST SIX WEEKS OF NON-OPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE PRODISC-C TOTAL DISC REPLACEMENT.
P060040||THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|||N|12/22/2006|04/21/2008|08M-0283|05/07/2008|APPR|APPROVAL FOR THE THORATEC HEARTMATE II LVAS. THIS DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NON-REVERSIBLE LEFT VENTRICULAR FAILURE. THE HEARTMATE II LVAS IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL, OR FOR TRANSPORTATION OF VENTRICULAR ASSIST DEVICE PATIENTS VIA GROUND AMBULANCE, FIXED-WING AIRCRAFT, OR HELICOPTER.
P070004||SIENTRA, INC|6769 HOLLISTER AVENUE|SUITE 201|SANTA BARBARA|CA|93117||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SIENTRA SILICONE GEL BREAST IMPLANTS|FTR|SU|||N|01/22/2007|03/09/2012|12M-0250|03/09/2012|APPR|APPROVAL FOR THE SIENTRA SILICONE GEL BREAST IMPLANTS. THIS DEVICE IS INDICATED FOR: 1) BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD.  BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF PRIMARY BREAST AUGMENTATION SURGERY; AND 2) BREAST RECONSTRUCTION. BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY. BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULTS OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
P070005||PATHFINDER CELL THERAPY INC.|12 BOW STREET||CAMBRIDGE|MA|02138||Barrier, adhesion, cardiovascular|REPEL-CV BIORESORBABLE ADHESION BARRIER|OBD|CV|||N|01/30/2007|03/06/2009|09M-0135|03/11/2009|APWD|APPROVAL FOR THE REPEL-CV BIORESORBABLE ADHESION BARRIER.  THE DEVICE IS INDICATED FOR REDUCING THE SEVERITY OF POST-OPERATIVE CARDIAC ADHESIONS IN PEDIATRIC PATIENTS WHO ARE LIKELY TO REQUIRE REOPERATION VIA STERNOTOMY.
P070006||OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T SPOT-TB TEST|OJN|MI|||N|02/06/2007|07/30/2008|08M-0477|08/26/2008|APPR|APPROVAL FOR THE T-SPOT-TB.  THIS DEVICE IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF EFFECTOR T CELLS THAT RESPOND TO STIMULATION BY MYCOBACTERIUM TUBERCULOSIS ANTIGENS ESAT-6 AND CFP-10 BY CAPTURING INTERFERON GAMMA (IFN-¿) IN THE VICINITY OF T CELLS IN HUMAN WHOLE BLOOD COLLECTED IN SODIUM CITRATE OR SODIUM OR LITHIUM HEPARIN.  IT IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF M. TUBERCULOSIS INFECTION.  T-SPOT-TB IS AN INDIRECT TEST FOR M. TUBERCULOSIS INFECTION (INCLUDING DISEASE) AND IS INTENDED FOR USE IN CONJUNCTION WITH RISK ASSESSMENT, RADIOGRAPHY AND OTHER MEDICAL AND DIAGNOSTIC EVALUATIONS.
P070007||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|||N|03/01/2007|06/05/2008|08M-0342|06/09/2008|APWD|APPROVAL FOR THE TALENT THORACIC STENT GRAFT SYSTEM.  THE DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF FUSIFORM ANEURYSMS AND SACCULAR ANEURYSMS/ PENETRATING ULCERS OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: 1) ILIAC/FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES; 2) NON-ANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18-42MM; AND 3) NON-ANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS >=20MM.
P070008||BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD|NKE|CV|||N|03/12/2007|05/12/2008|08M-0335|06/05/2008|APPR|APPROVAL FOR THE STRATOS LV CRT-P AND STRATOS LV-T CRT-P WITH 702.U PROGRAMMER SOFTWARE FOR THE ICS 3000 AND COROX OTW BP LEAD AND COROX OTW-S BP LEAD. THE STRATOS LV CRT-P AND THE STRATOS LV-T CRT-P ARE INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS II1/IV), INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF< 35%) AND QRS > 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY. THE COROX OTW BP AND COROX OTW-S BP LEFT VENTRICULAR PACING LEADS ARE BIPOLAR STEROID-ELUTING LEADS, INTENDED FOR PERMANENT IMPLANTATION IN THE LEFT VENTRICLE VIA THE CORONARY VEINS TO PROVIDE PACING AND/OR SENSING WHEN USED IN CONJUNCTION WITH A COMPATIBLE IS-1 PULSE GENERATOR.
P070009||OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X|LTI|GU|||N|04/02/2007|09/28/2007|07M-0380|11/09/2007|APPR|APPROVAL FOR THE REALIZE ADJUSTABLE GASTRIC BAND.  THIS DEVICE IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTS AND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OF AT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS.  THE BAND IS INDICATED FOR USE ONLY IN MORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.
P070012||Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|STENT, CAROTID|EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM|NIM|CV|||N|04/30/2007|10/23/2007|07M-0411|11/09/2007|APWD|APPROVAL FOR THE EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM.  THE DEVICE IS INDICATED FOR USE, IN CONJUNCTION WITH A MEDTRONIC VASCULAR EMBOLIC PROTECTION SYSTEM, FOR IMPROVING CAROTID LUMINAL DIAMETER IN PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY EITHER ULTRASOUND OR ANGIOGRAM, OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY EITHER ULTRASOUND OR ANGIOGRAM; AND 2) PATIENTS HAVING A VESSEL WITH REFERENCE DIAMETERS BETWEEN 4.5 MM AND 9.5 MM AT THE TARGET LESION.
P070013||COLBAR LIFESCIENCE LTD.|9 HAMENOFIM ST.||HERZLIYA||46733||Implant, dermal, for aesthetic use|EVOLENCE COLLAGEN FILLER|LMH|SU|||N|04/30/2007|06/27/2008|08M-0402|07/16/2008|APWD|APPROVAL FOR THE EVOLENCE COLLAGEN FILLER, WHICH IS INDICATED FOR THE CORRECTION OF MODERATE TO DEEP FACIAL WRINKLES AND FOLDS SUCH AS NASOLABIAL FOLDS.
P070014||BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM|NIP|CV|||N|05/25/2007|02/13/2009|09M-0127|03/10/2009|APPR|APPROVAL FOR THE LIFESTENT FLEXSTAR AND FLEXSTAR XL VASCULAR STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVEMENT OF LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 160 MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.00 - 6.5 MM.
P070015||ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE AND PROMUS EVEROLIMUS ELUTING  CORONARY STENT SYSTEMS|NIQ|CV|||N|06/01/2007|07/02/2008|08M-0535|10/07/2008|APPR|APPROVAL FOR THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, WHICH WILL ALSO BE DISTRIBUTED AS THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM.
P070016||WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM|MIH|CV|||N|07/02/2007|05/21/2008|08M-0311|05/27/2008|APPR|APPROVAL FOR THE ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM.  THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS; AND 2) NON-ANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE ANEURYSM OR ULCER: A) WITH A LENGTH OF AT LEAST 25 MM; AND B) WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 38 MM AND NO LESS THAN 24 MM.
P070022||HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|||N|08/10/2007|07/06/2009|09M-0317|07/14/2009|APWD|APPROVAL FOR THE ADIANA PERMANENT CONTRACEPTION SYSTEM.  THE DEVICE IS INDICATED FOR WOMEN WHO DESIRE PERMANENT BIRTH CONTROL (FEMALE STERILIZATION) BY OCCLUSION OF THE FALLOPIAN TUBES.
P070026||DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC HIP SYSTEM|MRA|OR|||N|10/01/2007|12/23/2010|11M-0035|01/25/2011|APPR|APPROVAL FOR THE CERAMAX CERAMIC TOTAL HIP SYSTEM.  THIS DEVICE IS INDICATED FOR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY TOTAL HIP REPLACEMENT SURGERY FOR REHABILITATION OF HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ANY OF ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS, AVASCULAR NECROSIS, AND POST-TRAUMATIC ARTHRITIS.
P070027||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|THE TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|||N|10/18/2007|04/15/2008|08M-0244|04/24/2008|APPR|APPROVAL FOR THE TALENT ABDOMINAL STENT GRAFT SYSTEM.  THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS WITH OR WITHOUT ILIAC INVOLVEMENT HAVING:1) ILIAC/FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES;2)  A PROXIMAL AORTIC NECK LENGTH OF >= 10MM;  3) PROXIMAL AORTIC NECK ANGULATION <= 60?; 4) DISTAL ILIAC ARTERY FIXATION LENGTH OF >=15MM;5) AN AORTIC NECK DIAMETER OF 18-32MM AND ILIAC ARTERY DIAMETERS OF 8-22MM; AND 6) VESSEL MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR.
P080002||THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60610||Condom, female, single-use|FC2 FEMALE CONDOM|MBU|OB|||N|01/08/2008|03/10/2009|09M-0159|03/25/2009|APPR|APPROVAL FOR THE FC2 FEMALE CONDOM.  THE DEVICE IS INDICATED FOR PREVENTING PREGNANCY, HIV/AIDS, AND OTHER SEXUALLY TRANSMITTED INFECTIONS (STIS).
P080003||HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Digital breast tomosynthesis|SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|OTE|RA|||N|01/22/2008|02/11/2011|11M-0131|03/09/2011|APPR|APPROVAL FOR THE SELENIA DIMENSIONS 3D SYSTEM.  THIS DEVICE IS INDICATED TO GENERATE DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER.  THE SELENIA DIMENSIONS (2D OR 3D) SYSTEM IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS 2D MAMMOGRAPHY SYSTEMS FOR SCREENING MAMMOGRAMS.  SPECIFICALLY, THE SELENIA DIMENSIONS SYSTEM CAN BE USED TO ACQUIRE 2D DIGITAL MAMMOGRAMS AND 3D MAMMOGRAMS.  THE SCREENING EXAMINATION WILL CONSIST OF A 2D IMAGE SET OR A 2D AND 3D IMAGE SET.  THE SELENIA DIMENSIONS SYSTEM MAY ALSO BE USED FOR ADDITIONAL DIAGNOSTIC WORKUP OF THE BREAST.
P080004||HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS|HQL|OP|||N|01/31/2008|09/26/2008|08M-0536|10/07/2008|APPR|APPROVAL FOR THE HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS.  THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
P080006||MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD|OJX|CV|||N|03/14/2008|04/07/2009|09M-0182|04/10/2009|APPR|APPROVAL FOR THE ATTAIN ABILITY MODEL 4196 LEAD.  THE ATTAIN ABILITY MODEL 4196 STEROID ELUTING, DUAL ELECTRODE, IS-1TRANSVENOUS LEAD IS INDICATED FOR CHRONIC PACING AND SENSING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM. EXTENDED BIPOLAR PACING IS AVAILABLE USING THIS LEAD IN COMBINATION WITH A COMPATIBLE CRT-D SYSTEM AND RV DEFIBRILLATION LEAD OR WITH A COMPATIBLE CRT-P SYSTEM AND RV PACING LEAD.
P080007||BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT|NIO|CV|||N|03/21/2008|12/04/2008|08M-0645|12/19/2008|APPR|APPROVAL FOR THE BARD E.LUMINEXX VASULAR STENT.  THE DEVICE IS INDICATED FOR THE TREATMENT F ILIAC OCCLUSIVE DISEASE IN PATIENTS WITH SYMPTOMATIC VASCULAR DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.
P080008||bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|VIDAS FREE PSA RT ASSAY|MTG|IM|||N|03/21/2008|10/08/2009|09M-0536|11/05/2009|APWD|APPROVAL FOR THE VIDASFREE PSA RT ASSAY. THE VIDAS FPSA RT IS AN AUTOMATED QUANTITATIVETEST FOR USE ON THE VIDAS INSTRUMENTS, FOR THE QUANTITATIVE MEASUREMENT OF THE FREE FRACTION OFPROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ELFA TECHNIQUE (ENZYME LINKEDFLUORESCENT ASSAY). THE VIDAS FPSA RT IS INTENDED TO BE USED IN CONJUNCTION WITH THE VIDASTPSA ASSAY IN MEN AGE 50 YEARS OR OLDER WHO HAVE DIGITAL RECTAL EXAMINATION (DRE) THAT IS NOTSUSPICIOUS FOR PROSTATE CANCER AND VIDAS TPSA VALUES BETWEEN 4 AND 10 NG/ML TO DETERMINE THE %FREE PSA VALUE. THE VIDAS %FPSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER.
P080009||ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|||Y|03/25/2008|05/03/2013|13M-0549|05/08/2013|APPR|APPROVAL FOR THE SEDASYS® COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM. THIS DEVICE IS INDICATED FOR THE INTRAVENOUS ADMINISTRATION OF 1% (10 MG/ML) PROPOFOL INJECTABLE EMULSION FOR THE INITIATION ANDMAINTENANCE OF MINIMAL TO MODERATE SEDATION, AS DEFINED BY THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) CONTINUUM OF DEPTH OF SEDATION, IN ASA PHYSICAL STATUS I AND II PATIENTS >= 18 YEARS OLD UNDERGOING COLONOSCOPY AND ESOPHAGOGASTRODUOD-DENOSCOPY (EGD) PROCEDURES.
P080010||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|MFK|OP|||N|04/02/2008|01/16/2009|09M-0034|01/27/2009|APPR|APPROVAL FOR THE TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), MODELS ZM900 AND ZMA00.THE DEVICES ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE.
P080011||COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A)|LPM|OP|||N|04/07/2008|11/19/2008|08M-0608|11/26/2008|APPR|APPROVAL FOR THEBIOFINITY (COMFILCON A) SOFT CONTACT LENS. THIS DEVICE IS INDICATED FOR USE AS FOLLOWS:BIOFINITY (COMFILCON A) SPHERE AND ASPHERC SOFT CONTACT LENSES ARE INDICATED FOR THECORRECTION OF AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BYPERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITHVISUAL ACUITY.BIOFINITY (COMFILCON A) TORIC SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OFAMETROPIA (MYOPIA OR HYPEROPIA WITH ASTIGMATISM) IN APHAKIC AND NON-APHAKIC PERSONSWITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS AND ASTIGMATICCORRECTIONS FROM -0.25 TO -5.00 DIOPTERS.BIOFINITY (COMFILCON A) MULTIFOCAL SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) AND EMMETROPIA WITH PRESBYOPIA INAPHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS WITH ADD POWERS FROM +0.50 TO +3.00 DIOPTERS. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.BIOFINITY (COMFILCON A) CONTACT LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR FOR UP TO 6 NIGHTS AND 7 DAYS OF CONTINUOUS WEAR. IT IS RECOMMENDED THAT THE CONTACT LENS WEARER BE FIRST EVALUATED ON A DAILY WEAR SCHEDULE PRIOR TO OVERNIGHT WEAR. THE LENSES MAY BEPRESCRIBED FOR EITHER ONE WEEK DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WITH CLEANING,DISINFECTION AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR FREQUENT REPLACEMENT, THELENSES MUST BE CLEANED AND DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY.
P080012||FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|||N|04/11/2008|02/07/2012|12M-0180|02/27/2012|APPR|APPROVAL FOR THE PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM.  THE DEVICE IS INDICATED FOR INTRATHECAL INFUSION OF INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION) OR PRESERVATIVE-FREE STERILE 0.9% SALINE SOLUTION (SODIUM CHLORIDE INJECTION, USP).
P080013||INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|||N|04/25/2008|09/04/2009|09M-0485|10/06/2009|APPR|APPROVAL FOR THE DURASEAL XACT SEALANT SYSTEM.  THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING SPINAL SURGERY TO PROVIDE WATERTIGHT CLOSURE.
P080014||HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT|MAQ|MI|||N|04/28/2008|03/12/2009|09M-0299|06/30/2009|APPR|APPROVAL FOR THE CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT.  CERVISTA HPV HR INDICATIONS FOR USE: THE CERVISTA HPV HR TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNAFROM 14 HIGH-RISK- HUMAN PAPILLOMAVIRUS (HPV) TYPES (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,59, 66, AND 68) IN CERVICAL SPECIMENS. THE CERVISTA HPV HR TEST CANNOT DETERMINE THESPECIFIC HPV TYPE PRESENT.THE CERVISTA HPV HR TEST USES THE INVADER CHEMISTRY, A SIGNAL AMPLIFICATION METHOD FORDETECTION OF SPECIFIC NUCLEIC ACID SEQUENCES. THIS METHOD USES TWO TYPES OF ISOTHERMAL REACTIONS:A PRIMARY REACTION THAT OCCURS ON THE TARGETED DNA SEQUENCE AND A SECONDARY REACTION THAT PRODUCES A FLUORESCENT SIGNAL.  THE CERVISTA HPV HR TEST IS INDICATED:1) TO SCREEN PATIENTS WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASCUS)CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY.2) IN WOMEN 30 YEARS AND OLDER THE CERVISTA HPV HR TEST CAN BE USED WITH CERVICALCYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPVTYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY,OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENTMANAGEMENT.  CERVICAL SPECIMENS THAT MAY BE TESTED WITH THE CERVISTA HPV HR TEST INCLUDE THE FOLLOWINGPRESERVATION SYSTEM COLLECTION MEDIA AND COLLECTION DEVICES:¿ THINPREP PAP TEST PRESERVCYT SOLUTION¿ BROOM-TYPE DEVICE (E.G. ROVERS CERVEX BRUSH, WALLACH PAPETTE), OR ENDOCERVICALBRUSH/SPATULA.GENFIND DNA EXTRACTION KIT INDICATION FOR USE:THE GENFIND DNA EXTRACTION KIT IS INTENDED FOR USE IN THE EXTRACTION OF DNA FROMCERVICAL SPECIMENS COLLECTED IN THINPREP PAP TEST PRESERVCYT SOLUTION FOR TESTINGBY THE CERVISTA HPV HR AND CERVISTA HPV 16/18 TESTS.
P080015||HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18|MAQ|MI|||N|04/28/2008|03/12/2009|09M-0299|06/30/2009|APPR|APPROVAL FOR THECERVISTA HPV 16/18.CERVISTA HPV 16/18 INDICATIONS FOR USE:THE CERVISTA HPV 16/18 TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNA FROM HUMAN PAPILLOMAVIRUS (HPV) TYPE 16 AND TYPE 18 IN CERVICAL SPECIMENS.THE CERVISTA HPV 16/18 TEST USES THE INVADER CHEMISTRY, A SIGNAL AMPLIFICATION METHOD FORDETECTION OF SPECIFIC NUCLEIC ACID SEQUENCES. THIS METHOD USES TWO TYPES OF ISOTHERMAL REACTIONS:A PRIMARY REACTION THAT OCCURS ON THE TARGETED DNA SEQUENCE AND A SECONDARY REACTION THAT PRODUCES A FLUORESCENT SIGNAL.CERVISTA HPV 16/18 TEST IS INDICATED:1) IN WOMEN 30 YEARS AND OLDER THE CERVISTA HPV 16/1S TEST CAN BE USED ADJUNCTIVELYWITH THE CERVISTA HPV HR TEST IN COMBINATION WITH CERVICAL CYTOLOGY TO SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES 16 AND 18. THIS INFORMATION,TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.  2) TO BE USED ADJUNCTIVELY WITH THE CERVISTA HPV HR TEST IN PATIENTS WITH ATYPICALSQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS, TOASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES 16 AND 18. THIS INFORMATION,TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY.CERVICAL SPECIMENS THAT MAY BE TESTED WITH THE CERVISTA HPV 16/18 TEST INCLUDE THE FOLLOWINGPRESERVATION SYSTEM AND COLLECTION DEVICES:THINPREP PAP TEST PRESERVCYT SOLUTION; AND¿ BROOM-TYPE DEVICE (E.G. ROVERS CERVEX BRUSH, WALLACH PAPETTE), OR ENDOCERVICALBRUSH/SPATULA.
P080018||CARESTREAM HEALTH, INC.|150 Verona Street||ROCHESTER|NY|14608||Full field digital,system,x-ray,mammographic|KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY|MUE|RA|||N|07/28/2008|11/03/2010|10M-0591|11/23/2010|APRL|APPROVAL FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM.  THE DEVICE IS INDICATED FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE TOGETHER WITH KODAK DIRECTVIEW CR MAMMOGRAPHY CASSETTE COMPRISE A DEVICE WHICH, WHEN USED IN CONJUNCTION WITH A KODAK DIRECTVIEW CR SYSTEM AND A MAMMOGRAPHIC X-RAY MACHINE, GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER.  IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM BASED MAMMOGRAPHIC SYSTEMS.  THE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY A QUALIFIED PHYSICIAN USING EITHER HARDCOPY FILM OR SOFTCOPY DISPLAY AT A WORKSTATION.
P080020||SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|||N|07/31/2008|03/22/2011|11M-0198|03/31/2011|APPR|APPROVAL FOR THE GEL-ONE.  THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO NON-PHARMACOLOGIC THERAPY, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) OR ANALGESICS, E.G., ACETAMINOPHEN.
P080021||BAUSCH & LOMB INCORPORATED|50 Technology Drive||Irvine|CA|92618||intraocular lens|XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|||N|08/07/2008|02/02/2009|09M-0049|02/06/2009|APPR|APPROVAL FOR THE XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL). MODEL X-60 AND MODEL X-70. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM THE CATARACTOUS LENS HAS BEEN REMOVED BY AN EXTRACAPSULAR CATARACT EXTRACTION METHOD. THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
P080023||Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS|LOM|MI|||N|08/28/2008|04/10/2009|09M-0244|05/27/2009|APPR|APPROVAL FOR THE ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS.  THESE DEVICES ARE INDICATED FOR:ARCHITECT CORE REAGENT KIT:THE ARCHITECT CORE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY(CMIA) FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B COREANTIGEN (ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA,LITHIUM HEPARIN, SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED AS AN AID IN THE DIAGNOSIS OF ACUTE, CHRONIC, OR RESOLVED HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.ARCHITECT CORE CALIBRATOR:THE ARCHITECT CORE CALIBRATOR IS USED FOR THE CALIBRATION OF THE ARCHITECT ISYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TOHEPATITIS B CORE ANTIGEN (ANTI-HBC) WITH THE ARCHITECT CORE REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE CALIBRATOR HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC ASSAYS.ARCHITECT CORE CONTROLS:THE ARCHITECT CORE CONTROLS ARC USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) WITH THE ARCHITECT CORE REAGENT KIT. THEPERFORMANCE OF THE ARCHITECT CORE CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHERANTI-HBC ASSAYS.
P080025||MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|||N|09/26/2008|03/14/2011|11M-0175|03/31/2011|APPR|APPROVAL FOR THE MEDTRONIC INTERSTIM THERAPY SYSTEM.  THE DEVICE IS INDICATED FOR THE TREATMENT OF CHRONIC FECAL INCONTINENCE IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
P080026||ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV ASSAY|MKT|MI|||N|10/16/2008|08/13/2010|10M-0519|10/01/2010|APPR|APPROVAL FOR THE ABBOTTREALTIME HBV. THE DEVICE IS INDICATED FOR:ABBOTT REALTIME HBV ASSAY:ABBOTT REALTIME HBV ASSAY IS AN IN VITRO POLYMERASE CHAIN REACTION (PCR) ASSAY FOR USE WITH THE ABBOTT M2000 SYSTEMDNA REAGENTS AND WITH THE ABBOTT M200SP AND M2OOORT INSTRUMENTSFOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM OR PLASMA (EDTA) FROM CHRONICALLY HBV-INFECTED INDIVIDUALS. THE ASSAY IS INTENDED FOR USE AS AN AID IN THEMANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM THE ABBOTT REALTIME HBV ASSAY MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. ASSAY PERFORMANCE FOR DETERMINING THE CLINICAL STAGE OF HBV INFECTION HAS NOT BEEN ESTABLISHED. CLINICAL PERFORMANCECHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH ADEFOVIR DIPIVOXIL. THIS ASSAYIS NOT INTENDED FOR USE AS A SCREENING TEST IN BLOOD OR BLOOD PRODUCTS FOR HBV OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV INFECTION. ABBOTT REALTIME HBV ASSAY CONTROL KIT:THE ABBOTT REALTIME HBV CONTROLS ARC USED TO ESTABLISH RUN VALIDITY OF THE ABBOTT REALTIMEHBV ASSAY WHEN USED FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUMAND PLASMA (EDTA) FROM HBV INFECTED INDIVIDUALS.ABBOTT REALTIME HBV ASSAY CALIBRATOR KIT:THE ABBOTT REALTIME HBV CALIBRATORS ARE FOR CALIBRATION OF THE ABBOTT REALTIME HBV ASSAY WHEN USED FOR THE QUANTITATION DETERMINATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM AND PLASMA (EDTA) FROM HBV INFECTED INDIVIDUALS.
P080027||ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|||N|10/24/2008|06/25/2010|10M-0402|07/30/2010|APPR|APPROVAL FOR THE ORAQUICK RAPID HCV ANTIBODY TEST.  THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN VENIPUNCTURE WHOLE BLOOD SPECIMENS (EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, AND SODIUM CITRATE) FROM INDIVIDUALS 15 YEARS OR OLDER.  THE ORAQUICK HCV RAPID ANTIBODY TEST RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION.
P080028||STORZ MEDICAL AG|LOHSTAMPFESTRASSE 8||TAGERWILEN||CH-82|8274|Generator, shock-wave, for pain relief|STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY|NBN|SU|||N|11/26/2008|01/08/2016|16M-0122|01/11/2016|APPR|APPROVAL FOR THE STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY. THIS DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE TREATMENT OF HEEL PAIN DUE TO CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PATIENTS OF AGE GREATER THAN 18 YEARS WITH A HISTORY OF FAILED ALTERNATIVE CONSERVATIVE THERAPIES FOR AT LEAST SIX MONTHS. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS TRACTION DEGENERATION OF THE PLANTAR FASCIAL BAND AT THE ORIGIN ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
P080029||INTERVENTIONAL THERAPIES, LLC.|1 GORHAM ISLAND||WESTPORT|CT|06880||Device, hemostasis, vascular|QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)|MGB|CV|||N|12/05/2008|04/08/2010|10M-0220|04/23/2010|APPR|APPROVAL FOR THE QUICK-CLOSE VASCULAR SUTURING SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS:THE QUICK-CLOSE VASCULAR SUTURING SYSTEM IS INDICATED TO CLOSE FEMORAL ARTERY ACCESSSITES AND TO REDUCE TIME-TO-HEMOSTASIS AND TIME-TO-AMBULATION IN PATIENTS WHO HAVEUNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5, 6, 7, OR 8FRENCH PROCEDURAL SHEATH. ADDITIONALLY, THE QUICK-CLOSE VASCULAR SUTURING SYSTEM IS INDICATED TO REDUCE TIME-TO-HEMOSTASIS IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONALENDOVASCULAR PROCEDURES UTILIZING A 5, 6, 7, OR 8 FRENCH PROCEDURAL SHEATH, WHO HAVERECEIVED INTRAPROCEDURAL GLYCOPROTEIN IIB/IIIA INHIBITOR THERAPY.
P080030||GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L|OGO|OP|||N|12/19/2008|06/25/2012|12M-0712|07/16/2012|APPR|APPROVAL FOR THE GLAUKOS ISTENT® TRABECULAR MICRO-BYPASS STENT (MODELS: GTS-100R, GTS-100L) AND INSERTER (GTS-L00I).  THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH CATARACT SURGERY FOR THE REDUCTION OFINTRAOCULAR PRESSURE (IOP) IN ADULT PATIENTS WITH MILD TO MODERATE OPEN-ANGLE GLAUCOMA CURRENTLY TREATED WITH OCULAR HYPOTENSIVE MEDICATION.
P080032||Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|||Y|12/30/2008|04/27/2010|10M-0242|05/19/2010|APPR|APPROVAL FOR THE ALAIR BRONCHIAL THERMOPLASTY SYSTEM.  THE DEVICE IS INDICATED FOR THE TREATMENT OF SEVERE PERSISTENT ASTHMA IN PATIENT 18 YEARS AND OLDER WHOSE ASTHMA IS NOT WELL CONTROLLED WITH INHALED CORTICOSTEROIDS AND LONG ACTING BETA AGONISTS.
P090002||DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|||N|02/17/2009|06/13/2011|11M-0470|06/15/2011|APWD|APPROVAL FOR THE PINNACLE COMPLETE ACETABULAR HIP SYSTEM. THIS DEVICE IS INDICATED FOR:THE PINNACLE COMPLETE ACETABULAR HIP SYSTEM IS A SINGLE USE DEVICE INTENDED FOR UNCEMENTED FIXATION. THE PINNACLE COMPLETE ACETABULAR HIP SYSTEM IS INTENDED AS A PRIMARY JOINT REPLACEMENT PROSTHESIS IN TOTAL HIP ARTHROPLASTY FOR SKELETALLY MATURE PATIENTS SUFFERING AT LEAST MODERATE PAIN IN THE HIP JOINT FROM NON-INFLAMMATORY DEGENERATIVE JOINTDISEASE (NIDJD) AND ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS (OA) OR POST-TRAUMATICARTHRITIS.  PINNACLE COMPLETE ACETABULAR HIP SYSTEM'S INSERTS (PINNACLE ULTAMET) ARE ONLY INTENDED FOR USE WITH DEPUY'S FEMORAL AND ACETABULAR COMPONENTS HAVING MATCHING OUTER AND INNER DIAMETERS.
P090003||BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|||N|02/23/2009|03/05/2010|10M-0135|03/24/2010|APPR|APPROVAL FOR THE EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM.  THE DEVICE IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC LESIONS FOUND IN ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE DIAMETER OF 6 MM TO 10 MM.
P090006||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|||N|04/15/2009|03/17/2010|10M-0158|03/26/2010|APPR|APPROVAL FOR THE COMPLETE SE VASCULAR STENT SYSTEM (20-100MM LENGTHS).  THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ILIAC STENOSIS IN PREVIOUSLY UNSTENTED LESIONS WITH VESSEL REFERENCE DIAMETERS BETWEEN 4.5MM AND 9.5MM AND LESION LENGTHS UP TO 90MM.
P090007||ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER|MZO|MI|||N|05/15/2009|04/29/2010|10M-0261|06/14/2010|APPR|APPROVAL FOR THE ELECSYSANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV ASSAY FOR USE ON COBAS E 411IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR:ELECSYS ANTI-HCV IMMUNOASSAYTHE ROCHE ELECSYS ANTI-HCV ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETECTION OF TOTAL ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM OR PLASMA(POTASSIUM EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITHOTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE PRESUMPTIVEDIAGNOSIS OF HCV INFECTION IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE.  THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE COBAS E411 IMMUNOASSAY ANALYZER.ELECSYS PRECICONTROL ANTI-HCVELECSYS PRECICONTROL ANTI-HCV IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HCV IMMUNOASSAY ON THE COBAS E 411 IMMUNOASSAY ANALYZER.
P090008||ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER|MZO|MI|||N|05/15/2009|04/29/2010|10M-0262|06/14/2010|APPR|APPROVAL FOR THE ELECSYSANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV ASSAY FOR USE ON COBAS E 601IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR:ELECSYS ANTI-HCV IMMUNOASSAYTHE ROCHE ELECSYS ANTI-HCV ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETECTION OF TOTAL ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM OR PLASMA(POTASSIUM EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITHOTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE PRESUMPTIVE DIAGNOSIS OF HCV INFECTION IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE.  THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE COBAS E601 IMMUNOASSAY ANALYZER.
P090009||ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER|MZO|MI|||N|05/15/2009|04/29/2010|10M-0264|06/14/2010|APPR|APPROVAL FOR THE ELECSYSANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV ASSAY FOR USE ON MODULAR ANALYTICS E170 ANALYZER. THIS DEVICE IS INDICATED FOR:ELECSYS ANTI-HCV IMMUNOASSAYTHE ROCHE ELECSYS ANTI-HCV ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETECTION OF TOTAL ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITHOTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE PRESUMPTIVE DIAGNOSIS OF HCV INFECTION IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE.  THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER.
P090012||STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|||Y|06/03/2009|11/01/2011|12M-0074|01/24/2012|APPR|APPROVAL FOR THE MELAFIND DEVICE.  MELAFIND IS INTENDED FOR USE ON CLINICALLY ATYPICAL CUTANEOUS PIGMENTED LESIONS WITH ONE OR MORE CLINICAL OR HISTORICAL CHARACTERISTICS OF MELANOMA, EXCLUDING THOSE WITH A CLINICAL DIAGNOSIS OF MELANOMA OR LIKELY MELANOMA. MELAFIND IS DESIGNED TO BE USED WHEN A DERMATOLOGIST CHOOSES TO OBTAIN ADDITIONAL INFORMATION FOR A DECISION TO BIOPSY. MELAFIND SHOULD NOT BE USED TO CONFIRM A CLINICAL DIAGNOSIS OF MELANOMA.  MELAFIND IS ONLY FOR USE BY PHYSICIANS TRAINED IN THE CLINICAL DIAGNOSIS AND MANAGEMENT OF SKIN CANCER (I.E., DERMATOLOGISTS) WHO HAVE ALSO SUCCESSFULLY COMPLETED A TRAINING PROGRAM IN THE APPROPRIATE USE OF MELAFIND.THE MELAFIND RESULT IS ONE ELEMENT OF THE OVERALL CLINICAL ASSESSMENT. MELAFIND POSITIVE LESIONS (WHICH MAY INCLUDE MALIGNANT MELANOMA, MELANOMA IN SITU, HIGH GRADE DYSPLASTIC NEVI AND ATYPICAL MELANOCYTIC PROLIFERATION/HYPER-PLASIA) SHOULD BE CONSIDERED FOR BIOPSY; THE BIOPSYDECISION OF A MELAFIND NEGATIVE LESION SHOULD BE BASED ON THE REMAINDER OF THE ENTIRE CLINICAL CONTEXT. LESIONS THAT ARE "NON-EVALUABLE" BY MELAFIND SHOULD BE CAREFULLY RE-EVALUATED FOR BIOPSY.MELAFIND IS INDICATED ONLY FOR USE ON LESIONS WITH A DIAMETER BETWEEN    2 MM AND 22 MM, LESIONS THAT ARE ACCESSIBLE BY THE MELAFIND IMAGER, LESIONS THAT ARE SUFFICIENTLY PIGMENTED (I.E. NOT FOR USE ON NON-PIGMENTED OR SKIN-COLORED LESIONS), LESIONS THAT DO NOT CONTAIN A SCAR ORFIBROSIS CONSISTENT WITH PREVIOUS TRAUMA, LESIONS WHERE THE SKIN IS INTACT (LE., NON-ULCERATED OR NON-BLEEDING LESIONS), LESIONS GREATER THAN 1 CM AWAY FROM THE EYE, LESIONS WHICH DO NOT CONTAIN FOREIGN MATTER, AND LESIONS NOT ON SPECIAL ANATOMIC SITES (IE., NOT FOR USE ON ACRAL,PALMAR, PLANTAR, MUCOSAL, OR SUBUNGUAL AREAS). MELAFIND IS NOT DESIGNED TO DETECT PIGMENTED NON-MELANOMA SKIN CANCERS, SO THE DERMATOLOGIST SHOULD RELY ON CLINICAL EXPERIENCE TO DIAGNOSE SUCH LESIONS.
P090013||Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG AND PACING SYSTEM|LWP|CV|||N|06/09/2009|02/08/2011|11M-0105|02/24/2011|APPR|APPROVAL FOR THE REVO MRISURESCAN PACING SYSTEM, WHICH CONSISTS OF THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG, THE MEDTRONIC CAPSUREFIX MRI¿ SURESCAN¿ 5086MRI LEAD, AND THE REVO MRI¿ SOFTWARE APPLICATION MODEL SW018. THIS SYSTEM IS INDICATED AS FOLLOWS:THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG IS INDICATED FOR USE AS A SYSTEM CONSISTING OF A REVO MRI SURESCAN IPG IMPLANTED WITH TWO CAPSURE FIX MRI¿SURESCAN¿ 5086MRI LEADS. A COMPLETE SYSTEM IS REQUIRED FOR USE IN THE MRI ENVIRONMENT.THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG IS INDICATED FOR THEFOLLOWING:1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RALESCONCURRENT WITH INCREASES IN ACTIVITY;2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE:A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND-DEGREE OR THIRD-DEGREE AV BLOCK;B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK;C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; ANDD) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOMEFORMS OF SYMPTOMATIC TACHYARRHYTHMIAS...(SEE APPROVAL ORDER FOR ADD'L DETAIL)
P090015||Leica Biosystems|36 Cherry Hill Drive||Danvers|MA|01923||SYSTEM, TEST, HER-2/NEU, IHC|BOND ORACLE HER2 IHC SYSTEM|MVC|PA|||N|07/22/2009|04/18/2012|12M-0390|04/25/2012|APPR|APPROVAL FOR THE BOND ORACLE HER2 IHC SYSTEM.  THIS DEVICE IS INDICATED FOR:  BOND ORACLE HER2 IHC SYSTEM IS A SEMI-QUANTITATIVE IMMUNOHISTOCHEMICAL (IHC) ASSAY TO DETERMINE HER2 (HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2) ONCOPROTEIN STATUS IN FORMALIN-FIXED, PARRAFIN EMBEDDED BREAST CANCER TISSUE PROCESSED FOR HISTOLOGICAL EVALUATION FOLLOWING AUTOMATED STAINING ON THE BOND-MAX SLIDE STAINING INSTRUMENT.  THE BOND ORACLE HER2 IHC SYSTEM IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.
P090016||MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|||N|07/23/2009|11/14/2011|11M-0832|11/22/2011|APPR|APPROVAL FOR BELOTERO BALANCE.  THIS DEVICE IS INDICATED FOR INJECTION INTO THE MID-TO-DEEP DERMIS FOR CORRECTION OF MODERATE-TO-SEVERE FACIAL WRINKLES AND FOLDS SUCH AS NASOLABIAL FOLDS.
P090018||ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM|OAF|EN|||Y|08/04/2009|03/17/2010|10M-0244|05/20/2010|APPR|APPROVAL FOR THE ESTEEM.  THE ESTEEM IS INTENDED TO ALLEVIATE HEARING LOSS IN PATIENTS BY REPLICATING THE OSSICULAR CHAIN AND PROVIDING ADDITIONAL GAIN.  THE ESTEEM IS INDICATED FOR PATIENTS WITH HEARING LOSS THAT MEET THE FOLLOWING CRITERIA: 1) 18 YEARS OF AGE OR OLDER;2) STABLE BILATERAL SENSORINEURAL HEARING LOSS;3) MODERATE TO SEVERE SENSORINEURAL HEARING LOSS DEFINED BY PURE TONE AVERAGE (PTA);4) UNAIDED SPEECH DISCRIMINATION TEST SCORE GREATER THAN OR EQUAL TO 40%;5) NORMALLY FUNCTIONING EUSTACHIAN TUBE;6) NORMAL MIDDLE EAR ANATOMY;7) NORMAL TYMPANIC MEMBRANE;8) ADEQUATE SPACE FOR ESTEEM IMPLANT DETERMINED VIA A HIGH RESOLUTION CT SCAN; AND9) MINIMUM 30 DAYS OF EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
P090022||LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|||N|09/01/2009|04/12/2010|10M-0220|04/23/2010|APPR|APPROVAL FOR THE SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL).  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21.  THE LENS IS INDICATED FOR CAPSULAR BAG PLACEMENT.
P090024||SIEMENS HEALTHCARE DIAGNOSTICS|511 Benedict Avenue||Tarrytown|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL|LOM|MI|||N|10/22/2009|10/11/2011|11M-0737|10/20/2011|APPR|APPROVAL FOR ADVIA CENTAUR HBEAG ASSAY & ADVIA CENTAUR HBEAG QUALITY CONTROL MATERIAL. THIS DEVICE IS INDICATED FOR:ADVIA CENTAUR HBEAG ASSAY:THE ADVIA CENTAUR HBEAG ASSAY IS AN IN-VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF THE HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) FROM INDIVIDUALS WHO HAVE SIGNS ANDSYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS ASSAY, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, IS INTENDED ONLY FOR THE DETERMINATION OF CHRONIC INFECTION WITH HEPATITIS B VIRUS.ADVIA CENTAUR HBEAG QUALITY CONTROL MATERIAL:THE CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE HBEAG ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBEAG QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBEAG ASSAY.
P090026||BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|||N|11/17/2009|06/14/2012|12M-0638|06/20/2012|APPR|APPROVAL FOR THE ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS. THIS DEVICE IS INDICATED FOR:  THE ACCESS HYBRITECH P2PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF [-2]PROPSA ANTIGEN, AN ISOFORM OF FREEPSA, IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS.  ACCESS HYBRITECH P2PSA IS INTENDED TO BE USED IN COMBINATION WITH ACCESS HYBRITECH (TOTAL) PSA AND ACCESS HYBRITECH FREE PSA TO CALCULATE THE BECKMAN COULTER PROSTATE HEALTH INDEX (PHI), AN IN VITRO DIAGNOSTIC MULTIVARIATE INDEX ASSAY (IVDMIA).  BECKMAN COULTER PHI AS CALCULATED USING THE ACCESS HYBRITECH ASSAYS IS INDICATED FOR USE ASAN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIONS, FOR PROSTATE CANCER DETECTION IN MEN AGED 50 YEARS AND OLDER WITH TOTAL PSA >= 4.0 TO <= 10.0 NG/ML, AND WITH DIGITAL RECTAL EXAMINATION FINDINGS THAT ARE NOT SUSPICIOUS FOR CANCER.  PROSTATIC BIOPSYIS REQUIRED FOR DIAGNOSIS OF CANCER.
P090028||Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS|LOM|MI|||N|12/16/2009|05/11/2011|11M-0348|05/20/2011|APPR|APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK, CALIBRATOR AND CONTROLS.  THIS DEVICE IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK  FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM.  TEST RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION.  VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG CALIBRATOR FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION.  VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG CONTROLS - FOR USE IN MONITORING THE PERFORMANCE OF THE  VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS WHEN USED FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION WHEN USING THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBE-AG REAGENT PACK.
P090029||Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE LP CERVICAL DISC|MJO|OR|||N|12/22/2009|07/24/2014|14M-1113|08/07/2014|APPR|APPROVAL FOR THE PRESTIGE® LP CERVICAL DISC. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE LEVEL OF THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT AS COMPARED TO ADJACENT LEVELS. THE PRESTIGE® LP CERVICAL DISC IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF NON-OPERATIVE TREATMENT OR HAVE HAD THE PRESENCE OF PROGRESSIVE SYMPTOMS OR SIGNS OF NERVE ROOT/SPINAL CORD COMPRESSION IN THE FACE OF CONTINUED NON-OPERATIVE MANAGEMENT PRIOR TO IMPLANTATION OF THE PRESTIGE® LP CERVICAL DISC.
P090031||Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|MONOVISC|MOZ|OR|||N|12/29/2009|02/25/2014|14M-0254|03/05/2014|APPR|APPROVAL FOR THE MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TOCONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
P100001||ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS|LOM|MI|||N|01/29/2010|07/20/2011|11M-0563|08/01/2011|APPR|APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, CALIBRATOR AND CONTROLS. THIS DEVICE IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF CHRONIC HEPATITIS AND THOSE WHO HAVE RECOVERED FROM HBV INFECTION, USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS. FURTHER ASSESSMENT OF HBV INFECTION (BIOCHEMICAL, SEROLOGICAL AND/OR NUCLEIC ACID TESTING) IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE.  VITROS ANTI-HBE TEST PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV  DISEASE OR THERAPY.  VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS WHEN USED WITH THE VITROS ANTI-HBE TEST FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE).  VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CONTROLS FOR USE IN MONITORING THE PERFORMANCE OF THE VITROS ANTI-HBE TEST WHEN USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS.
P100003||GLOBUS MEDICAL INC.|2560 GENERAL ARMISTEAD AVE.||AUDUBON|PA|19403||PROSTHESIS, INTERVERTEBRAL DISC|SECURE-C ARTIFICIAL CERVICAL DISC|MJO|OR|||N|01/29/2010|09/28/2012|12M-1039|10/02/2012|APPR|APPROVAL FOR THE SECURE-C ARTIFICIAL CERVICAL DISC. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OFTHE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE- LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVELABNORMALITY LOCALIZED TO THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT AS COMPARED TO ADJACENT LEVELS. THE SECURE-C CERVICAL ARTIFICIAL DISC IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE SECURE-C CERVICAL ARTIFICIAL DISC.
P100005||ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|M-VU ALGORITHM ENGINE|MYN|RA|||N|02/01/2010|01/23/2012|12M-0082|01/26/2012|APPR|APPROVAL FOR THE M-VU ALGORITHM ENGINE.  THE DEVICE IS INDICATED FOR USE IN SCREENING MAMMOGRAPHY TO IDENTIFY AREAS CONSISTENT WITH BREAST CANCER FOR RADIOLOGIST REVIEW AFTER COMPLETING AN INITIAL READ.
P100006||BIOMIMETIC THERAPEUTICS,LLC|389 Nichol Mill Ln||FRANKLIN|TN|37067||Filler, bone void, synthetic peptide|AUGMENT BONE GRAFT|NOX|OR|||N|02/04/2010|09/01/2015|15M-3257|10/13/2015|APPR|APPROVAL FOR AUGMENT® BONE GRAFT. THIS DEVICE IS INDICATED FOR USE AS AN ALTERNATIVE TO AUTOGRAFT IN ARTHRODESIS (I.E., SURGICAL FUSION PROCEDURES) OF THE ANKLE (TIBIOTALAR JOINT) AND/OR HINDFOOT (INCLUDING SUBTALAR, TALONAVICULAR, AND CALCANEOCUBOID JOINTS, ALONE OR IN COMBINATION), DUE TO OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AVASCULAR NECROSIS, JOINT INSTABILITY, JOINT DEFORMITY, CONGENITAL DEFECT, OR JOINT ARTHROPATHY IN PATIENTS WITH PREOPERATIVE OR INTRAOPERATIVE EVIDENCE INDICATING THE NEED FOR SUPPLEMENTAL GRAFT MATERIAL.
P100007||ALMEN LABORATORIES, INC.|1672 GIL WAY||VISTA|CA|92084||Analyzer,medical image|BREAST COMPANION SOFTWARE SYSTEM|MYN|RA|||N|02/17/2010|02/10/2012|12M-0172|03/06/2012|APPR|APPROVAL FOR THE BREAST COMPANION SOFTWARE SYSTEM.  THE BREAST COMPANION IS A COMPUTER-AIDED SYSTEM INTENDED FOR IMPROVING THE ACR BI-RADS ASSESSMENT OF ULTRASOUND IMAGES OF LESIONS OF THE FEMALE BREAST AS PART OF THE DIAGNOSTIC WORKSHOP.
P100009||ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP DELIVERY SYSTEM|NKM|CV|||Y|03/04/2010|10/24/2013|13M-1365|11/15/2013|APPR|APPROVAL FOR THE MITRACLIP CLIP DELIVERY SYSTEM (MITRACLIP CDS). THIS DEVICE IS INDICATED FOR THE PERCUTANEOUS REDUCTION OFSIGNIFICANT SYMPTOMATIC MITRAL REGURGITATION (MR >= 3+) DUE TO PRIMARY ABNORMALITY OF THE MITRAL APPARATUS [DEGENERATIVE MR] IN PATIENTS WHO HAVE BEEN DETERMINED TO BE AT PROHIBITIVE RISK FOR MITRAL VALVE SURGERY BY A HEART TEAM, WHICH INCLUDES A CARDIAC SURGEON EXPERIENCED IN MITRAL VALVE SURGERY AND A CARDIOLOGIST EXPERIENCED IN MITRAL VALVE DISEASE, AND IN WHOM EXISTING COMORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM REDUCTION OF THE MITRAL REGURGITATION.
P100010||Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CRYOCATHETER SYSTEM|OAE|CV|||N|03/12/2010|12/17/2010|11M-0041|02/01/2011|APPR|APPROVAL OF THE ARCTIC FRONT CRYOCATHETER SYSTEM.  THE DEVICE IS INDICATED FOR THE TREATMENT OF DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION.
P100012||NUVASIVE, INC.|7475 LUSK BLVD||SAN DIEGO|CA|92121||PROSTHESIS, INTERVERTEBRAL DISC|NUVASIVE PCM CERVICAL DISC SYSTEM|MJO|OR|||N|04/01/2010|10/26/2012|12M-1111|11/08/2012|APPR|APPROVAL FOR THE PCM CERVICAL DISC SYSTEM. THIS DEVICE IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS FOR  RECONSTRUCTION OF A DEGENERATED CERVICAL DISC AT ONE LEVEL FROM C3-C4 TO C6-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT), WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE DISC SPACE, AND MANIFESTED BY AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING(CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT AS COMPARED TO ADJACENT LEVELS. THE PCM CERVICAL DISC IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE PCM CERVICAL DISC.
P100013||Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|CORDIS EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|||N|04/01/2010|05/19/2011|11M-0430|06/03/2011|APPR|APPROVAL FOR THE EXOSEAL VASCULAR CLOSURE DEVICE.  THIS DEVICE IS INDICATED AS FOLLOWS:  THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IS INDICATED FOR FEMORAL ARTERY PUNCTURE SITE CLOSURE, REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING A STANDARD 5F, 6F, OR 7F VASCULAR SHEATH INTRODUCER WITH UP TO 12 CM WORKING LENGTH.  ADDITIONALLY,  THE EXOSEAL VCD IS INDICATED TO REDUCE TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL CATHETERIZATION PROCEDURES, USING A STANDARD 6F VASCULAR SHEATH INTRODUCER UP TO A 12 CM WORKING LENGTH, WHO HAVE RECEIVED PREPROCEDURAL AND/OR INTRAPROCEDURAL GLYCOPROTEIN (GP) IIB/IIIA INHIBITOR THERAPY.
P100014||VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA INJECTABLE GEL|LNM|GU|||N|04/09/2010|05/27/2011|11M-0445|06/15/2011|APPR|APPROVAL FOR THE SOLESTA.  THIS DEVICE IS INDICATED FOR THE TREATMENT OF FECAL INCONTINENCE IN PATIENTS 18 YEARS AND OLDER WHO HAVE FAILED CONSERVATIVE THERAPY (E.G., DIET, FIBER THERAPY, ANTI-MOTILITY MEDICATIONS).
P100016||AAREN SCIENTIFIC INC|4290 EAST BRICKELL STREET|BLDG A|ONTARIO|CA|91761||intraocular lens|EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL|HQL|OP|||N|04/22/2010|10/19/2010|10M-0556|11/17/2010|APPR|APPROVAL FOR THE EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL.  THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
P100017||ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV|MZP|MI|||N|05/18/2010|05/17/2011|11M-0349|05/20/2011|APPR|THE APPROVAL OF REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT REALTIME HCV CALIBRATOR KIT, AND OPTIONAL UNG URACIL-N-GLYCOSYLASE (UNG) FOR USE IN CONJUNCTION WITH ABBOTT REALTIME HCV.  THIS DEVICE IS INDICATED FOR: ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, THE ABBOTT REAL TIME HCV ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION- POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR USE WITH THE ABBOTT MSAMPLE PREPARATION SYSTEM REAGENTS AND WITH THE ABBOTT M2000SP AND M2000RY4 INSTRUMENTS FOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA IN HUMAN SERUM OR PLASMA (EDTA) FROM HCV-INFECTED INDIVIDUALS.  SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE BEEN VALIDATED FOR QUANTITATION IN THE ASSAY.  THE ABBOTT REALTIME HCV ASSAY IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTIVIRAL THERAPY.  THE ASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND CAN BE UTILIZED TO PREDICT SUSTAINED AND NON- SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY.  THE RESULTS FROM THE REALTIME HCV ASSAY MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.  ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH PEGINTERFERON ALFA-2A OR 2B PLUS RIBAVIRIN.  NO INFORMATION IS AVAILABLE ON THE ASSAYS PREDICTIVE VALUE WHEN OTHER THERAPIES ARE USED.   ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED.  THE ABBOTT REALTIME HCV ASSAY IS NOT FOR SCREENING BLOOD, PLASMA, SERUM OR TISSUE DONORS FOR HCV, OR TO BE USED AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HCV INFECTION.  ABBOTT REALTIME HCV CONTROL KIT, THE ABBOTT REALTIME HCV CONTROLS ARE USED TO ESTABLISH RUN VALIDITY OF THE ABBOTT REALTIME HCV ASSAY WHEN USED FOR THE QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN SERUM AND PLASMA (EDTA) FROM HCV INFECTED INDIVIDUALS...FOR ADDITIONAL INFO REFER TO APPROVAL ORDER.
P100018||MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|||Y|05/18/2010|04/06/2011|11M-0284|04/20/2011|APPR|APPROVAL FOR THE PIPELINE EMBOLIZATION DEVICE.  THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (AGE 22 AND ABOVE) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS.
P100020||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|||N|06/01/2010|04/19/2011|11M-0300|05/06/2011|APPR|APPROVAL FOR THE COBAS HPV TEST.  COBAS HPV TEST INDICATIONS FOR USE:  THE COBAS HPV TEST IS A QUALITATIVE IN VITRO TEST FOR THE DETECTION OF HUMAN PAPILLOMAVIRUS (HPV) IN PATIENT SPECIMENS.  THE TEST UTILIZES AMPLIFICATION OF TARGET DNA BY THE POLYMERASE CHAIN REACTION (PCR) AND NUCLEIC ACID HYBRIDIZATION FOR THE DETECTION OF 14 HIGH-RISK (HR) HPV TYPES IN A SINGLE ANALYSIS.  THE TEST SPECIFICALLY IDENTIFIES TYPES HPV 16 AND HPV 18 WHILE CONCURRENTLY DETECTING THE REST OF THE REST OF THE HIGH RISK TYPES (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 AND 68).  THE COBAS HPV TEST IS INDICATED:  1) TO SCREEN PATIENTS 21 YEARS AND OLDER WITH ASC-US (ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE) CERVICAL CYTOLOGY TEST RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY; AND  2) TO BE USED IN PATIENTS 21 YEARS AND OLDER WITH ASC-US CERVICAL CYTOLOGY RESULTS, TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV GENOTYPES 16 AND 18.  THIS INFORMATION, TOGETHER WITH THE PHYSICIAN¿S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.  THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY; 3)  IN WOMEN 30 YEARS AND OLDER, THE COBAS HPV TEST CAN BE USED WITH CERVICAL CYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH RISK HPV TYPES.  THIS INFORMATION, TOGETHER WITH THE PHYSICIAN¿S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT; AND  4)  IN WOMEN 30 YEARS AND OLDER, THE COBAS HPV TEST CAN BE USED TO ASSESS THE PRESENCE OR ABSENCE OF HPV GENOTYPES 16 AND 18.  THIS INFORMATION, TOGETHER WITH THE PHYSICIAN¿S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT....(SEE APPROVAL ORDER FOR ADDITIONAL APPROVAL STATEMENT DETAIL).
P100021||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM|MIH|CV|||N|06/04/2010|12/16/2010|11M-0040|01/25/2011|APPR|APPROVAL FOR THE ENDURANT STENT GRAFT SYSTEM.  THE DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS IN PATIENTS WITH THE FOLLOWING CHARACTERISTICS: 1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; 2) PROXIMAL NECK LENGTH OF >= 10MM; 3) INFRARENAL NECK ANGULATION <= 60 DEGREES; 4) DISTAL FIXATION LENGTH OF >= 15 MM; 5) AORTIC NECK DIAMETERS WITH A RANGE OF 19 TO 32 MM; 6) ILIAC DIAMETERS WITH A RANGE OF 8 TO 25 MM; AND 7) MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR.
P100022||COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|||N|06/04/2010|11/14/2012|12M-1146|11/30/2012|APPR|APPROVAL FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO OR RESTENOTIC SYMPTOMATIC LESIONS IN NATIVE VASCULAR DISEASE OF THE ABOVE-THE-KNEE FEMOROPOPLITEAL ARTERIES HAVING REFERENCE VESSEL DIAMETERS FROM 4 MM TO 9 MM AND TOTAL LESION LENGTHS UP TO 140 MM PER LIMB AND 280 MM PER PATIENT.
P100023||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)|NIQ|CV|||N|06/17/2010|04/22/2011|11M-0342|05/12/2011|APPR|APPROVAL FOR THE ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM.  THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVE LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <= MM IN LENGTH.
P100024||DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|||N|06/21/2010|11/30/2011|11M-0866|12/09/2011|APPR|APPROVAL FOR THE HER2 CISH PHARMDX KIT. THIS DEVICE IS INDICATED TOR;HER2 CISH PHARMDX KIT IS INTENDED FOR DUAL-COLOR CHROMOGENIC VISUALIZATION OF SIGNALS ACHIEVED WITH DIRECTLY LABELED IN SITU HYBRIDIZATION PROBES TARGETING THE HER2 GENE AND CENTROMERIC REGION OF CHROMOSOME 17. THE KIT IS DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE STATUS IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. RED AND BLUE CHROMOGENIC SIGNALS ARE GENERATED ON THE SAME TISSUE SECTION FOR EVALUATION UNDER BRIGHT FIELD MICROSCOPY. THE CISH PROCEDURE IS AUTOMATED USING DAKO AUTOSLAINERINSTRUMENTS. HER2 CISH  PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.  RESULTS FROM THE HER2 CISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGIC INFORMATIONCURRENTLY USED FOR ESTIMATING PROGNOSIS IN STAGE II, NODE-POSITIVE BREAST CANCER PATIENTS.
P100025||OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0|OZA|MI|||N|06/22/2010|02/22/2012|12M-0207|03/07/2012|APPR|APPROVAL FOR THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0. THE BREATHTEK UBT KIT IS CURRENTLY CLEARED FOR USE INADULT PATIENTS UNDER 510(K) PREMARKET NOTIFICATION, K014225, AND THE PRANACTIN-CITRIC IS APPROVED UNDER NDA 20-586/S-004. THIS DEVICE IS INDICATED FOR: THE BREATHTEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) IS INTENDED FOR USE IN THE QUALITATIVE DETECTION OF UREASE ASSOCIATED WITH H. PYLORI IN THE HUMAN STOMACH AND IS INDICATED AS AN AID IN THE INITIAL DIAGNOSIS AND POST-TREATMENT MONITORING OF H. PYLORI INFECTION IN ADULTS, AND PEDIATRIC PATIENTS 3 TO 17 YEARS OLD. THE TEST MAY BE USED FORMONITORING TREATMENT IF USED AT 4 WEEKS FOLLOWING COMPLETION OF THERAPY.  FOR THESE PURPOSES, THE SYSTEM UTILIZES AN INFRARED SPECTROPHOTOMETER FOR THE MEASUREMENT OF THE RATIO OF 13CO2 TO 12CO2 IN BREATH SAMPLES, IN CLINICAL LABORATORIES AND POINT-OF-CARE SETTINGS. THE PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), PROVIDED AS A WEB-BASED CALCULATION PROGRAM, IS REQUIRED TO OBTAIN PEDIATRIC TEST RESULTS. THE BREATHTEK UBT KIT IS FORADMINISTRATION BY A HEALTH CARE PROFESSIONAL, AS PRESCRIBED BY A PHYSICIAN.
P100026||NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|||N|07/02/2010|11/14/2013|12M-1488|11/25/2013|APPR|APPROVAL FOR THE RNS SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS: " ... AS AN ADJUNCTIVE THERAPY IN REDUCING THE FREQUENCY OF SEIZURES IN INDIVIDUALS 18 YEARS OF AGE OR OLDER WITH PARTIAL ONSET SEIZURES WHO HAVE UNDERGONE DIAGNOSTIC TESTING THAT LOCALIZEDNO MORE THAN 2 EPILEPTOGENIC FOCI, ARE REFRACTORY TO TWO OR MORE ANTIEPILEPTIC MEDICATIONS, AND CURRENTLY HAVE FREQUENT AND DISABLING SEIZURES (MOTOR PARTIAL SEIZURES, COMPLEX PARTIAL SEIZURESAND/ OR SECONDARILY GENERALIZED SEIZURES). THE RNS SYSTEM HAS DEMONSTRATED SAFETY AND EFFECTIVENESS IN PATIENTS WHO AVERAGE 3 OR MORE DISABLING SEIZURES PER MONTH OVER THE THREE MOST RECENT MONTHS (WITH NO MONTH WITH FEWER THAN TWO SEIZURES), AND HAS NOT BEEN EVALUATED IN PATIENTS WITH LESS  FREQUENT SEIZURES."
P100027||VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|||N|07/12/2010|06/14/2011|11M-0472|06/15/2011|APPR|APPROVAL FOR THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL. THIS DEVICE IS INDICATED FOR:THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INTENDED FOR USE IN DETERMINING HER2 GENE STATUS BY ENUMERATION OF THE RATIO OF THE HER2 GENE TO CHROMOSOME 17. THE HER2 AND CHROMOSOME 17 PROBES ARE DETECTED USING TWO COLOR CHROMOGENIC IN SITU HYBRIDIZATION (ISH) IN FORMALIN-FIXED. PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS FOLLOWING STAINING ON VENTANA BENCHMARK XT AUTOMATED SLIDE STAINERS (USING NEXES SOFTWARE), BY LIGHT MICROSCOPY. THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM I-HERPCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED READER IN CONJUNCTION WITH HISTOLOGICAL EXAMINATION,  RELEVANT CLINICAL INFORMATION, AND PROPER CONTROLS.THIS REAGENT IS INTENDED FOR IN VITRO DIAGNOSTIC (IVD) USE.
P100028||COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|STENT, RENAL|FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM|NIN|CV|||N|07/19/2010|01/14/2011|11M-0056|01/26/2011|APPR|APPROVAL FOR THE FORMULA BALLOON- EXPANDABLE RENAL STENT SYSTEM.  THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUB-OPTIMAL PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC LESION (<= 18 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE RENAL OSTIUM AND WITH A REFERENCE VESSEL DIAMETER OF 4.0 - 7.0 MM.  SUPOPTIMAL PTRA IS DEFINED AS >= 50% RESIDUAL STENOSIS, >= 20 MMHG SYSTOLIC OR >= 10 MMHG MEAN TRANSLESIONAL PRESSURE GRADIENT, OR FLOW-LIMITING DISSECTION.
P100029||St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST JUDE MEDICAL TRIFECTA VALVE|LWR|CV|||N|07/20/2010|04/20/2011|11M-0296|05/06/2011|APPR|APPROVAL FOR THE ST. JUDE MEDICAL TRIFECTA VALVE.  THE TRIFECTA VALVE IS INTENDED AS A REPLACEMENT FOR A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVE.
P100030||MALLINCKRODT PHARMA IP TRADING DAC|DAMASTOWN INDUSTRIAL ESTATE||MULHUDDART||||Sealant,polymerizing|ARTERX SURGICAL SEALANT|NBE|CV|||N|07/27/2010|03/01/2013|13M-0281|03/14/2013|APPR|APPROVAL FOR THE ARTERX SURGICAL SEALANT.  THIS DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
P100031||ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC|LOM|MI|||N|07/30/2010|06/22/2011|11M-0502|07/01/2011|APPR|APPROVAL FOR THE ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUM-HEPARIN, SODIUM-CITRATE, K2-EDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ELECSYS ANTI-HBC IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING HBV DISEASE OR THERAPY. THE ELECTRO- CHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE MODULAR ANALYTICS EI70 IMMUNOASSAY ANALYZER. THE ELECSYS PRECI-CONTROL ANTI-HBC IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER.
P100032||ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER|LOM|MI|||N|07/30/2010|06/27/2011|11M-0503|07/01/2011|APPR|APPROVAL FOR THE ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUM-HEPARIN, SODIUM-CITRATE, K2-EDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ELECSYS ANTI-HBC IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER. THE ELECSYS PRECICONTROL ANTI-HBC IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER.
P100033||GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Prostrate cancer genes nucleic acid amplification test system|PROGENSA PCA3 ASSAY|OYM|PA|||N|08/10/2010|02/13/2012|12M-0173|03/06/2012|APPR|APPROVAL FOR THE PROGENSA PCA3 ASSAY.  THIS DEVICE IS INDICATED FOR:  PROGENSA PCA3 ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST.  THE ASSAY MEASURES THE CONCENTRATION OF PROSTATE CANCER GENE 3 (PCA3) AND PROSTATE-SPECIFIC ANTIGEN (PSA) RNA (RNA) MOLECULES AND CALCULATES THE RATIO OF PCA3 RNA MOLECULES TO PSA RNA MOLECULES (PCA3 SCORE) IN POST DIGITAL RECTAL EXAM (DRE) FIRST CATCH MALE URINE SPECIMENS.  THE PROGENSA PCA3 ASSAY IS INDICATED FOR USE IN CONJUNCTION WITH OTHER PATIENT INFORMATION TO AID IN THE DECISION FOR REPEAT BIOPSY IN MEN 50 YEARS OF AGE OR OLDER WHO HAVE HAD ONE OR MORE PREVIOUS NEGATIVE PROSTATE BIOPSIES AND FOR WHOM A REPEAT BIOPSY WOULD BE RECOMMENDED BY A UROLOGIST BASED ON CURRENT STANDARD OF CARE, BEFORE CONSIDERATION OF PROGENSA PCA3 ASSAY RESULTS.A PCA3 SCORE <25 IS ASSOCIATED WITH A DECREASED LIKELIHOOD OF A POSITIVE BIOPSY.  PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.
P100034||Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT|NZK|NE|||Y|08/16/2010|04/08/2011|11M-0295|05/06/2011|APPR|APPROVAL FOR THE NOVOTTF-100A SYSTEM.  THE DEVICE IS INDICATED FOR TREATMENT OF ADULT PATIENTS (22 YEARS OF AGE OR OLDER) WITH HISTOLOGICALLY- CONFIRMED GLIOBLASTOMA MULTIFORME, FOLLOWING HISTOLOGICALLY- OR RADIOLOGICALLY- CONFIRMED RECURRENCE IN THE SUPRATENTORIAL REGION OF THE BRAIN AFTER RECEIVING CHEMOTHERAPY.  THE DEVICE IS INTENDED TO BE USED AS A MONOTHERAPY, AND IS INTENDED AS AN ALTERNATIVE TO STANDARD MEDICAL THERAPY FOR GBM AFTER SURGICAL AND RADIATION OPTIONS HAVE BEEN EXHAUSTED.
P100039||SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL|LOM|MI|||N|08/17/2010|01/20/2012|12M-0075|01/24/2012|APPR|APPROVAL FOR ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL FOR USE ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS.  THIS DEVICE IS INDICATED FOR:  ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY,  THE ADVIA CENTAUR ANTI-HB2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OF PLASMA (EDTA, LITHIUM-HEPARINIZED, OR SODIUM-HEPARINIZED) AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS.  THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.THIS ASSAY HAS NOT BEEN FDA-CLEARED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.  ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL,  FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS2 ASSAY ON THE ADVIA CENTAUR SYSTEMS.  THE PERFORMANCE OF THE ANTI-HBS2 QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.
P100040||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT SYSTEM|MIH|CV|||N|10/08/2010|04/01/2011|11M-0257|04/20/2011|APPR|APPROVAL FOR THE FALIANT THORACIC STENT GRAFT WITH THE CAPTIVA DELIVERY SYSTEM.  THE DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF FUSIFORM AND ANEURYSMS/PENETRATING ULCERS OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: 1) ILIAC/FEMORAL ACCESS VESSLE MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES; 2) NON-ANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18-42 MM; AND 3) NON-ANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS >=20 MM.
P100041||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE  AND ACCESSORIES|NPT|CV|||Y|11/01/2010|11/02/2011|11M-0837|11/22/2011|APPR|APPROVAL FOR THE SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23MM AND 26MM AND ACCESSORIES.  THIS DEVICE IS INDICATED FOR TRANSFEMORAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC NATIVE AORTIC VALVE STENOSIS WHO HAVE BEEN DETERMINED BY A CARDIAC SURGEON TO BE INOPERABLE FOR OPEN AORTIC VALVE REPLACEMENT AND IN WHOM EXISTING COMORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM CORRECTION OF THE AORTIC STENOSIS.
P100042||GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|||N|11/05/2010|10/28/2011|11M-0792|11/04/2011|APPR|APPROVAL FOR THE APTIMA HPV ASSAY.APTIMA HPV ASSAY INDICATIONS FOR USE:THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTIONOFE6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18,31,33,35, 39,45,51,52,56,58,59,66, AND 68. THE APTIMA HPV ASSAY DOES NOT DISCRIMINATE BETWEEN THE14 HIGH-RISK TYPES. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTIONAND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/ SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THEAPTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM.  THE USE OF THE TEST IS INDICATED:I. TO SCREEN PATIENTS 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TOCOLPOSCOPY.  2. IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV ASSAY CAN BE USED WITH CERVICAL CYTOLOGYTO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.* BROOM-TYPE DEVICE (E.G., WALLACH PIPETTE) OR ENDOCERVICAL BRUSH/SPATULA.
P100044||INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL|OWO|EN|||N|12/06/2010|08/11/2011|11M-0600|08/19/2011|APPR|APPROVAL FOR THE PROPEL SINUS IMPLANT.  THIS DEVICE IS INDICATED FOR USE IN PATIENTS >= 18 YEARS OF AGE FOLLOWING ETHMOID SINUS SURGERY TO MAINTAIN PATENCY, THEREBY REDUCING THE NEED FOR POST-OPERATIVE INTERVENTION SUCH AS SURGICAL ADHESION LYSIS AND/OR USE OF ORAL STEROIDS.  THE PROPEL SINUS IMPLANT SEPARATES MUCOSAL TISSUES, PROVIDES STABILIZATION OF THE MIDDLE TURBINATE, PREVENTS OBSTRUCTION BY ADHESIONS, AND REDUCES EDEMA.
P100045||St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM|MOM|CV|||Y|12/15/2010|05/28/2014|14M-0727|06/10/2014|APPR|APPROVAL FOR THE CARDIOMEMS HF SYSTEM, WHICH INCLUDES THE CM2000 IMPLANTABLE PA SENSOR/MONITOR AND TRANSVENOUS CATHETER DELIVERY SYSTEM, THE CM1000 PATIENT ELECTRONICS SYSTEM (GSM), THECM1010 PATIENT ELECTRONICS SYSTEM (GSM), AND CM3000 HOSPITAL ELECTRONICS SYSTEM. THIS DEVICE IS INDICATED FOR WIRELESSLY MEASURING AND MONITORING PULMONARY ARTERY (PA) PRESSURE AND HEART RATE IN NEW YORK HEART ASSOCIATION (NYHA) CLASS III HEART FAILURE PATIENTS WHO HAVE BEEN HOSPITALIZED FOR HEART FAILURE IN THE PREVIOUS YEAR. THE HEMODYNAMIC DATA ARE USED BY PHYSICIANS FOR HEART FAILURE MANAGEMENT AND WITH THE GOAL OF REDUCING HEART FAILURE HOSPITALIZATIONS.
P100046||ATRICURE INC.|386 WEST MAIN STREET, SUITE 7||NORTHBOROUGH|MA|01532||Surgical cardiac ablation device, for treatment of atrial fibrillation|ATRICURE SYNERGY ABLATION SYSTEM|OCM|CV|||Y|12/23/2010|12/14/2011|11M-0910|12/19/2011|APPR|APPROVAL FOR THE ATRICURE SYNERGY ABLATION SYSTEM. THIS DEVICE IS INDICATED FOR THE ABLATION OF CARDIAC TISSUE FOR THETREATMENT OF PERSISTENT ATRIAL FIBRILLATION (SUSTAINED BEYOND SEVEN DAYS, OR LASTING LESS THAN SEVEN DAYS BUT NECESSITATING PHARMACOLOGIC OR ELECTRICAL CARDIOVERSION) OR LONGSTANDING PERSISTENT ATRIALFIBRILLATION (CONTINUOUS ATRIAL FIBRILLATION OF GREATER THAN ONE YEAR DURATION) IN PATIENTS WHO ARE UNDERGOING OPEN CONCOMITANT CORONARY ARTERY BYPASS GRAFTING AND/OR VALVE REPLACEMENT OR REPAIR.
P100047||Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|||N|12/28/2010|11/20/2012|12M-1184|12/05/2012|APPR|APPROVAL FOR THE HEARTWARE VENTRICULAR ASSIST SYSTEM (VAS). THIS DEVICE IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE HEART WARE VAS IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS, INCLUDING TRANSPORTATION VIA FIXED WING AIRCRAFT OR HELICOPTER.
P100049||TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|||N|12/30/2010|03/22/2012|12M-0893|08/14/2012|APPR|APPROVAL FOR THE LINX REFLUX MANAGEMENT SYSTEM.  THIS DEVICE IS INDICATED FOR PATIENTS DIAGNOSED WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD) AS DEFINED BY ABNORMAL PH TESTING, AND WHO CONTINUE TO HAVE CHRONIC GERD SYMPTOMS DESPITE MAXIMUM THERAPY FOR THE TREATMENT OF REFLUX.
P110001||ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|RX HERCULINK ELITE RENAL STENT SYSTEM|NIN|CV|||N|01/03/2011|07/20/2011|11M-0564|08/01/2011|APPR|APPROVAL FOR THE RX HERCULINK ELITE RENAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUB-OPTIMAL PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESION (<= 15 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE RENAL OSTIUM AND WITH A REFERENCE VESSEL DIAMETER OF 4.0 - 7.0 MM. SUBOPTIMAL PTRA IS DEFINED AS >= 50% RESIDUAL STENOSIS, >= 20 MMHG PEAK SYSTOLIC OR >=  10 MMHG MEAN TRANSLESIONAL PRESSURE GRADIENT, FLOW-LIMITING DISSECTION, OR TIMI [THROMBOLYSIS IN MYOCARDIAL INFARCTION] FLOW <= 3.
P110002||LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)|MJO|OR|||N|01/14/2011|08/07/2013|13M-0987|08/22/2013|APPR|APPROVAL FOR THE MOBI-C® CERVICAL DISC PROSTHESIS. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLERADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE LEVEL OF THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT COMPARED TO ADJACENT LEVELS. THE MOBI-C® CERVICAL DISC PROSTHESIS IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT ORDEMONSTRATED PROGRESSIVE SIGNS OR SYMPTOMS DESPITE NONOPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE MOBI-C® CERVICAL DISC PROSTHESIS.
P110003||GENZYME CORP.|500 KENDALL STREET||CAMBRIDGE|MA|02142|1562|Occluder, internal vessel, temporary|LEGOO|OBC|CV|||N|01/31/2011|09/28/2011|11M-0746|10/20/2011|APPR|APPROVAL FOR THE LEGOO.  THIS DEVICE IS INDICATED FOR TEMPORARY ENDOVASCULAR OCCLUSION OF BLOOD VESSELS BELOW THE NECK UP TO 4 MM IN DIAMETER.
P110004||MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|PRESILLION PLUS COCR CORONARY STENT RX SYSTEM|MAF|CV|||N|02/09/2011|04/12/2012|12M-0407|05/01/2012|APPR|APPROVAL FOR THE PRESILLION PLUS COCR CORONARY STENT ON RX SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE ASSOCIATED WITH STENOTIC LESIONS IN DE NOVO NATIVE CORONARY ARTERIES (LENGTH <= 30 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM TO 4.00MM.
P110005||IBSA INSTITUT BIOCHIMIQUE SA|VIA AL PONTE 13, CH-6903||LUGANO TICINO||6903||Acid, hyaluronic, intraarticular|SINOVIAL (SODIUM HYALURONATE 0.8%)|MOZ|OR|||N|02/10/2011|05/09/2014|14M-0691|05/29/2014|APPR|APPROVAL FOR GEL-SYN.  THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS (E.G. ACETAMINOPHEN).
P110006||U-SYSTEMS, INC.|9900 WEST INNOVATIVE DRIVE|MAIL STOP RP2138|WAUWATOSA|WI|53226||Automated breast ultrasound|SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)|PAA|RA|||N|02/11/2011|09/18/2012|12M-1011|09/25/2012|APPR|APPROVAL FOR THE SOMO-V:  AUTOMATED BREAST ULTRASOUND SYSTEM (ABUS). THIS DEVICE IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREAST CANCER SCREENING IN ASYMPTOMATIC WOMEN FOR WHOM SCREENINGMAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BI-RADS COMPOSITION/DENSITY 3 OR 4) AND HAVE NOT HAD PREVIOUS CLINICALBREAST INTERVENTION. THE DEVICE IS INTENDED TO INCREASE BREAST CANCER DETECTION IN THE DESCRIBED PATIENT POPULATION.
P110007||ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)|LZP|OP|||N|02/22/2011|07/02/2012|12M-0734|07/16/2012|APPR|APPROVAL FOR THE HEALON ENDOCOAT OVD. HEALON ENDOCOAT OVD IS AN OPHTHALMIC VISCOELASTIC CONTAINING 3% SODIUM HYALURONATE INDICATED FOR USE AS A SURGICAL AID IN PATIENTS UNDERGOING OPHTHALMIC ANTERIOR SEGMENT SURGICAL PROCEDURES INCLUDING, CATARACT SURGERY WITH AN INTRAOCULAR LENS, CATARACT SURGERY WITHOUT AN INTRAOCULAR LENS, AND SECONDARY INTRAOCULAR LENS IMPLANTATION. HEALON ENDOCOAT OVD MAINTAINS A DEEP CHAMBER DURING ANTERIOR SEGMENT SURGERY, ENHANCES VISUALIZATION DURING THE SURGICAL PROCEDURE AND PROTECTS THE CORNEAL ENDOTHELIUM AND OTHER OCULAR TISSUE. THE VISCOELASTICITY OF THE SOLUTION MAINTAINS THE NORMAL POSITION OF THE VITREOUS FACE AND PREVENTS FORMATION OF A FLAT CHAMBER DURING SURGERY. IT MAY ALSO BE USED TO COAT INTRAOCULAR LENSES AND INSERTION INSTRUMENTS PRIOR TO INTRAOCULAR LENS IMPLANTATION.
P110008||PARADIGM SPINE, LLC|505 PARK AVENUE, 14TH  FLOOR||NEW YORK|NY|10022||Prosthesis, spinous process spacer/plate|COFLEX® INTERLAMINAR TECHNOLOGY|NQO|OR|||N|03/03/2011|10/17/2012|12M-1085|11/08/2012|APPR|APPROVAL FOR THE COFLEX INTERLAMINAR TECHNOLOGY.  THIS DEVICE IS INDICATED FOR USE IN ONE- OR TWO-LEVEL LUMBAR STENOSIS FROM L1- L5 IN SKELETALLY MATURE PATIENTS WITH AT LEAST MODERATE IMPAIRMENT IN FUNCTION, WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCKS/ GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND WHO HAVE UNDERGONE AT LEAST 6 MONTH OF NON-OPERATIVE TREATMENT. THE COFLEX IS INTENDED TO BE IMPLANTED MIDLINE BETWEEN ADJACENT LAMINA OF 1 OR 2 CONTIGUOUS LUMBAR MOTION SEGMENTS. INTERLAMINAR STABILIZATION IS PERFORMED AFTER DECOMPRESSION OF STENOSIS AT THE AFFECTED LEVEL(S).
P110009||LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)|MJO|OR|||N|03/11/2011|08/23/2013|13M-1095|09/10/2013|APPR|APPROVAL FOR THE MOBI-C® CERVICAL DISC PROSTHESIS. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING DISCECTOMY AT TWO CONTIGUOUS LEVELS FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO ABNORMALITY LOCALIZED TO THE LEVEL OF THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT COMPARED TO ADJACENT LEVELS. THE MOBI-C® CERVICAL DISC PROSTHESIS IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT OR DEMONSTRATED PROGRESSIVE SIGNS OR SYMPTOMS DESPITE NONOPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE MOBIC® CERVICAL DISC PROSTHESIS.
P110010||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|||N|03/28/2011|11/22/2011|11M-0865|12/09/2011|APPR|APPROVAL FOR THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=28 MM INLENGTH.
P110011||MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|||N|04/01/2011|10/26/2011|11M-0791|11/04/2011|APPR|APPROVAL FOR THE ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING ILIAC LUMINAL DIAMETER IN PATIENTS WITH DE NOVO AND RESTENOTIC LESIONS IN THE COMMON AND EXTERNAL ILIAC ARTERIES, WITH REFERENCE VESSEL DIAMETERS BETWEEN 6 MM AND 10 MM AND LESION LENGTHS UP TO 61 MM. THE STENT IS INTENDED AS A PERMANENT IMPLANT.
P110012||ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK|OWE|PA|||Y|04/01/2011|08/26/2011|11M-0630|09/06/2011|APPR|APPROVAL FOR THE VYSIS ALK BREAK APART FISH PROBE KIT; VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT; PROBECHEK ALK NEGATIVE CONTROL SLIDES; AND PROBECHEK ALK POSITIVE CONTROL SLIDES. THIS DEVICE IS INDICATED FOR:  THE VYSIS ALK BREAK APART FISH PROBE KIT IS A QUALITATIVE TEST TO DETECT REARRANGEMENTS INVOLVING THE ALK GENE VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN FORMALIN-FIXED PARAFFIN -EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE SPECIMENS TO AID IN IDENTIFYING THOSE PATIENTS ELIGIBLE FOR TREATMENT WITH XALKORI CRIZOTINIB).  THE TEST IS FOR PRESCRIPTION USE ONLY. THE VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT IS USED TO PREPARE PARAFFIN-EMBEDDED LUNG CANCER TISSUE SECTIONS FIXED ON POSITIVELY CHARGED SLIDES FOR USE IN FLUORESCENCE IN SITU HYBRIDIZATION (FISH) WITH VYSIS DNA FISH PROBES.THE PROBECHEK ALK NEGATIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK NEGATIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK POSITIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK POSITIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020).
P110013||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE MICROTRAC/RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|||N|04/01/2011|02/17/2012|12M-0177|03/07/2012|APPR|APPROVAL FOR THE RESOLUTE MICROTRAC ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM AND RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS.  THESE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETERS IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH 27 <= MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.2 MM.
P110014||DUNE MEDICAL DEVICES INC|111 SPEEN ST SUITE 101||FRAMINGHAM|MA|01701||Diagnostic low electric field|DUNE MEDICAL DEVICES MARGINPROBE SYSTEM|OEE|SU|||Y|04/04/2011|12/27/2012|13M-0036|01/08/2012|APPR|APPROVAL FOR THE MARGINPROBE SYSTEM. THIS DEVICE IS AN ADJUNCTIVE DIAGNOSTIC TOOL FOR IDENTIFICATION OF CANCEROUS TISSUE AT THE MARGINS (<= 1MM) OF THE MAIN EX-VIVO LUMPECTOMY SPECIMEN FOLLOWING PRIMARY EXCISION AND IS INDICATED FOR INTRAOPERATIVE USE, IN CONJUNCTION WITH STANDARD METHODS (SUCH AS INTRAOPERATIVE IMAGING AND PALPATION) IN PATIENTS UNDERGOING BREAST LUMPECTOMY SURGERY FOR PREVIOUSLY DIAGNOSED BREAST CANCER.
P110015||ADVANCED BREATH DIAGNOSTICS|105 WESTPARK DR.|SUITE 150|BRENTWOOD|TN|37027||Gastric Emptying Breath Test|GASTRIC EMPTYING BREATH TEST (GEBT)|PGE|CH|||N|04/13/2011|04/06/2015|15M-1178|04/14/2015|APPR|APPROVAL  FOR THE GASTRIC EMPTYING BREATH TEST (GEBT). THIS DEVICE, TO BE USED WITH THE GEBT TEST MEAL, IS INTENDED FOR USE IN THE MEASUREMENT OF THE RATE OF GASTRIC EMPTYING OF SOLIDS AND AS AN AID IN THE DIAGNOSIS OF DELAYED GASTRIC EMPTYING (GASTROPARESIS) IN ADULT HUMANS WHO ARE SYMPTOMATIC FOR GASTOPARESIS. FOR THESE PURPOSES, THE TEST SYSTEM UTILIZES A GAS ISOTOPE RATIO MASS SPECTROMETER (GIRMS) FOR THE MEASUREMENT OF THE RATIO OF 13CO2 TO 12CO2 IN BREATH SAMPLES. THE GEBT PROCEDURE SHOULD BE ADMINISTERED UNDER SUPERVISION OF A HEALTH CARE PROFESSIONAL ALTHOUGH NO SPECIALIZED FACILITIES OR SPECIALLY LICENSED PERSONNEL ARE REQUIRED.
P110016||St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR|OAD|CV|||N|04/15/2011|01/25/2012|12M-0112|02/02/2012|APPR|APPROVAL FOR THE THERAPY COOL PATH DUO ABLATION CATHETER; SAFIRE BLU DUO ABLATION CATHETER; AND IBI 1500T-9 VI.6 CARDIAC ABLATION GENERATOR. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMPAND 1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
P110019||ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|||N|04/20/2011|11/01/2011|11M-0796|11/04/2011|APPR|APPROVAL FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32 MM) WITH REFERENCE VESSEL DIAMETERS OF >= 2.25 MM TO <= 4.25 MM.
P110020||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|||N|04/25/2011|08/17/2011|11M-0601|08/19/2011|APPR|APPROVAL FOR THE COBAS 4800 BRAF V600 MUTATION TEST.  THIS DEVICE IS INDICATED FOR:  THE COBAS 4800 BRAF V600 MUTATION TEST IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION OF THE BRAF V600E MUTATION IN DNA EXTRACTED FROM FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN MELANOMA TISSUE.  THE COBAS 4800 BRAF V600 MUTATION TEST IS A REAL-TIME PCR TEST ON THE COBAS 4800 SYSTEM, AND IS INTENDED TO BE USED AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E MUTATION FOR TREATMENT WITH VEMURAFENIB.
P110021||EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|||Y|05/02/2011|10/19/2012|12M-1088|11/07/2012|APPR|APPROVAL FOR EDWARDS SAPIEN¿ TRANSCATHETER HEART VALVE MODEL 9000TFX, SIZES 23MM AND 26MM, AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES LISTED ABOVE. THIS DEVICE IS INDICATED FOR THE FOLLOWING:TRANSAPICAL - THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23 MM AND 26 MM, IS INDICATED FOR TRANSAPICAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVESTENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION >= 20% WHO HAVE BEEN EXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TO BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >= 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >=15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT. THE ASCENDRA BALLOON CATHETER IS INDICATED FOR THE TRANSAPICAL DELIVERY OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE. TRANSFEMORALTHE EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23 MM AND 26 MM, ISINDICATED FOR TRANSFEMORAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVESTENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION >20% WHO HAVE BEENEXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TOEITHER BE: 1) INOPERABLE AND IN WHOM EXISTING CO-MORBIDITIES WOULD NOT PRECLUDE THE EXPECTEDBENEFIT FROM CORRECTION OF THE AORTIC STENOSIS; OR 2) BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A SOCIETY OF THORACIC SURGEONS PREDICTED OPERATIVE RISK SCORE  > 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT.THE RETROFLEX 3 DELIVERY SYSTEM IS INDICATED FOR THE TRANSFEMORAL DELIVERY OF THE EDWARDSSAPIEN TRANSCATHETER HEART VALVE.
P110022||ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM|LOM|MI|||N|05/09/2011|10/26/2011|11M-0786|11/04/2011|APPR|APPROVAL FOR THE ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM FOR USE ON THE COBAS E 601 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR: THE ELECSYS ANTI-HBC IGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN. SODIUM HEPARIN, SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (1IBV) INJECTION. THE PRESENCE OF ANTI-HBC IGM. IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, IS INDICATIVE OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS ANTI-HBC IGM IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.THE ELECTROCHEMILU-MINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE COBAS E 601 IMMUNOASSAY ANALYZER. PRECICONTROI ANTI-HBC IGM ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IGM  IMMUNOASSAY ON THE COBAS E 601 IMMUNOASSAY ANALYZER.
P110023||MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)|NIP|CV|||N|06/13/2011|03/07/2012|12M-0221|03/14/2012|APPR|APPROVAL FOR THE EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE NOVO OR RESTENOTIC LESIONS UP TO 180MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.5 -7.5MM.
P110024||ADVANCED CIRCULATORY SYSTEMS, INC.|1905 COUNTY ROAD C WEST||ROSEVILLE|MN|55113||Combination compression/decompression manual chest pump with impedance respiratory valve|RESQCPR SYSTEM|PIZ|CV|||Y|06/15/2011|03/06/2015|15M-0738|03/19/2015|APPR|APPROVAL FOR THE RESQCPR SYSTEM. THIS DEVICE IS INDICATED FOR USE AS A CPR ADJUNCT TO IMPROVE THE LIKELIHOOD OF SURVIVAL IN ADULT PATIENTS WITH NON-TRAUMATIC CARDIAC ARREST.
P110025||ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA|LOM|MI|||N|06/23/2011|12/14/2011|11M-0917|12/21/2011|APPR|APPROVAL FOR THE ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAL YTICS E170 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR:THE ELECSYS ANTI-HBC IGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMANSERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN, SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV)INFECTION. THE PRESENCE OF ANTI-HBC IGM, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, IS INDICATIVE OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS ANTI-HBC IGM IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.  THE ECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE MODULAR ANAL YTICS E170 IMMUNOASSAY ANALYZER.  ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBCIGM IMMUNOASSAY ON THE MODULAR ANAL YTICS E170 IMMUNOASSAY ANALYZER.
P110027||QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN KRAS RGQ PCR KIT|OWD|PA|||N|07/25/2011|05/23/2014|14M-0726|06/10/2014|APPR|APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT, WHICH IS TO BE USED AS A COMPANION DIAGNOSTIC FOR THE DRUG VECTIBIX (PANITUMUMAB). THIS DEVICE IS INDICATED FOR:THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTOR-GENE Q MDX INSTRUMENT FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN THE HUMAN KRAS ONCOGENE, USING DNA EXTRACTED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE), COLORECTAL CANCER (CRC) TISSUE. THE THERASCREEN KRAS RGQ PCR KIT IS INTENDED TO AID IN THE IDENTIFICATION OF CRC PATIENTS FOR TREATMENT WITH ERBITUX (CETUXIMAB) AND VECTIBIX (PANITUMUMAB) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT.
P110028||ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|||N|07/25/2011|02/22/2012|12M-0181|02/27/2012|APPR|APPROVAL FOR THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESIONS IN THE NATIVE COMMON ILIAC ARTERY AND NATIVE EXTERNAL ILIAC ARTERY WITH REFERENCE VESSEL DIAMETERS BETWEEN 4.3 MM AND 9.1 MM AND LESIONS LENGTHS UP TO 90 MM.
P110029||Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS|LOM|MI|||N|07/26/2011|04/12/2012|12M-0372|04/17/2012|APPR|APPROVAL FOR THE ARCHITECT HBSAG QUALITATIVE, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY MANUAL DILUENT, ARCHITECT HBSAG QUALITATIVE CALIBRATORS, AND ARCHITECT HBSAG QUALITATIVE CONTROLS. THIS DEVICE IS INDICATED FOR: ARCHITECT HBSAG QUALITATIVE - THE ARCHITECT HBSAG QUALITATIVE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA AND NEONATE SERUM. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK FOR ACQUIRING HEPATITIS BDURING THE PERINATAL PERIOD.  ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF  HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION.  NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS. ARCHITECT HBSAG QUALITATIVE CONFIRMATORY - THE ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA AND NEONATE SERUM BY MEANS OF SPECIFIC ANTIBODY NEUTRALIZATION. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH THE HEPATITIS B VIRUS (HBV) (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS B INFECTION.  NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS.  (FOR ADDITIONAL INFORMATION, PLEASE REFER TO APPROVAL ORDER).
P110030||QIAGEN MANCHESTER LTD|SKELETON HOUSE, LLOYD STREET NORTH||MANCHESTER||||Somatic gene mutation detection system|THERASCREEN KRAS RGQ PCR KIT|OWD|PA|||N|07/28/2011|07/06/2012|12M-0735|07/16/2012|APWD|APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT. THIS DEVICE IS INDICATED FOR:  THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTORGENE Q MDX INSTRUMENT FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN THE HUMAN KRAS ONCOGENE, USING DNA EXTRACTED FROM FORMALIN FIXED PARAFFIN-EMBEDDED (FFPE), COLORECTAL CANCER (CRC) TISSUE. THE THERASCREEN KRAS RGQ PCR KIT IS INTENDED TO AID IN THE IDENTIFICATION OF CRC PATIENTS FOR TREATMENT WITH ERBITUX (CETUXIMAB) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT.
P110031||ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM|LOM|MI|||N|07/29/2011|01/03/2012|12M-0024|01/10/2012|APPR|APPROVAL FOR THE ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM  FOR USE ON THE COBAS E 411 IMMUNOASSAY ANALYZER.  THE DEVICE IS INDICATED FOR: ELECSYS ANTI-HBC IGM IMMUNOASSAY,  THE ELECSYS ANTI-HBC IGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN, SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION.  THE PRESENCE OF ANTI-HBC IGM, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, IS INDICATIVE OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION.  THE ELECSYS ANTI-HBC IGM IMMUNOASSAYS PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE COBAS E 411 IMMUOASSAY ANALYZER.ELECSYS  PRECICONTROL ANTI-HBC IGM  - THE ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR THE QUALITY CONTROL OF THE ELECSYS ANTI-HBC IGM IMMUNOASSAY ON THE COBAS E 411 IMMUNOASSAY ANALYZER.
P110032||LOMBARD MEDICAL TECHNOLOGIES INC|15420 LAGUNA CANYON ROAD|SUITE 260|IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AORFIX FLEXIBLE STENT GRAFT SYSTEM|MIH|CV|||N|08/15/2011|02/14/2013|13M-0282|03/13/2013|APPR|APPROVAL FOR THE AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULARREPAIR, INCLUDING:1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, IMPLANTS, AND ACCESSORIES; 2) AORTIC NECK LANDING ZONE DIAMETERS WITH A RANGE OF 19MM TO 29MM; 3)  NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF >=  L5MM; 4) LNFRARENAL AORTIC NECK ANGULATIONS INCLUDING THOSE UP TO AND INCLUDING 90°; 5) COMMON ILIAC LANDING ZONE DIAMETERS WITH A RANGE OF 9MM TO 19MM; AND 6) DISTAL FIXATION LENGTH OF >= 15MM.
P110033||Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|||N|08/29/2011|10/22/2013|13M-1364|11/20/2013|APPR|APPROVAL FOR THE JUVEDERM VOLUMA TM XC. THIS DEVICE IS INDICATED FOR DEEP (SUBCUTANEOUS AND/OR SUPRAPERIOSTEAL) INJECTION FOR CHEEK AUGMENTATION TO CORRECT AGE-RELATED VOLUME DEFICIT IN THE MIDFACE IN ADULTS OVER THE AGE OF 21.
P110035||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC SELF-EXPANDING NITINOL STENT SYSTEM|NIO|CV|||N|09/13/2011|04/13/2012|12M-0373|04/25/2012|APPR|APPROVAL FOR THE EPIC VASCULAR SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR THE IMPROVEMENT OF LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC SYMPTOMATIC ATHEROSCLEROTIC LESIONS UP TO 120 MM IN LENGTH IN THE COMMON AND/OR EXTERNAL ILIAC ARTERIES, WITH A REFERENCE VESSEL DIAMETER BETWEEN 5 AND 11 MM.
P110037||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)|PAB|MI|||N|10/24/2011|07/05/2012|12M-0713|07/11/2012|APPR|APPROVAL FOR THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST. THIS DEVICE IS INDICATED FOR: THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATIVE MEASUREMENT OF CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMENPROCESSING AND THE COBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION.  THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF SOLID-ORGAN TRANSPLANT PATIENTS WHO ARE UNDERGOING ANTI-CMV THERAPY.  IN THIS POPULATION SERIAL DNA MEASUREMENTS CAN BE USED TO ASSESS VIROLOGICAL RESPONSE TO ANTIVIRAL TREATMENT. THE RESULTS FROM THE COBAS AMPLIPREP/COBAS TAQMAN CMVTEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF CMV DNA IN BLOOD OR BLOOD PRODUCTS.
P110038||BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|||N|11/04/2011|09/21/2012|12M-1012|10/02/2012|APPR|APPROVAL FOR THE RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF FUSIFORM ANEURYSMS AND SACCULAR ANEURYSMS/ PENETRATING ATHEROSCLEROTIC ULCERS IN THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING:  1) ILIAC OR FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; 2) NON-ANEURYSMAL AORTIC NECK DIAMETER IN THE RANGE OF 19 - 42 MM; AND 3) NON-ANEURYSMAL PROXIMAL AORTIC NECK LENGTHS BETWEEN 15 AND 25 NUN AND DISTAL AORTIC NECK LENGTHS BETWEEN 25 AND 30 MM DEPENDING ON THE DIAMETER STENT-GRAFT REQUIRED.
P110039||InSightec|5 NAHUM HETH STREET||TIRAT-CARMEL||39120||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE|NRZ|SU|||Y|12/05/2011|10/18/2012|12M-1085|11/08/2012|APPR|APPROVAL FOR THE EXABLATE SYSTEM, MODEL 2000/2100 /2100 VI. THIS DEVICE IS INDICATED FOR PAIN PALLIATION OF METASTATIC BONE CANCER IN PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE  SUFFERING FROM BONE PAIN DUE TO METASTATIC DISEASE AND WHO ARC FAILURES OF STANDARD RADIATION THERAPY, OR NOT CANDIDATES FOR, OR REFUSED RADIATION THERAPY. THE BONE TUMOR TO BE TREATED MUST BE VISIBLE ON NON-CONTRAST MR AND DEVICE ACCESSIBLE.
P110040||Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM|NIP|CV|||N|12/12/2011|09/19/2013|13M-1159|09/23/2013|APPR|APPROVAL FOR THE MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN SYMPTOMATIC PATIENTS WITH DE NOVO AND/OR RESTENOTIC LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OR PROXIMAL POPLITEAL ARTERY (PPA) WITH REFERENCE DIAMETERS RANGING FROM 4 MM TO 7 MM AND LESION LENGTHS UP TO 140 MM.
P110041||SIEMENS CORP.|511 Benedict Avenue||Tarrytown|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAGII|LOM|MI|||N|12/19/2011|05/16/2014|14M-0692|06/10/2014|APPR|APPROVAL FOR THE ADVIA CENTAUR HBSAGII, ADVIA CENTAUR HBSAG CONFIRMATORY, AND ADVIA CENTAUR HBSAG QUALITYCONTROL MATERIAL. THIS DEVICE IS INDICATED FOR:ADVIA CENTAUR HBSAGII (HBSII) -THE ADVIA CENTAUR HBSAGII (HBSII) ASSAY IS AN IN VITRO IMMUNOASSAY FOR THE QUALITATIVEDETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM AND PLASMA (EDT A, LITHIUM-HEPARIN, OR SODIUM-HEPARIN), AND NEONATAL SAMPLES USINGTHE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTIONWITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONICHEPATITIS B INFECTION. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD.ADVIA CENTAUR HBSAG CONFIRMATORYTHE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO IMMUNOASSAY FOR THE CONFIRMATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUMEDTA, LITHIUM-HEPARIN, OR SODIUM-HEPARIN), AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OFHBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIA CENTAUR HBSAGII ASSAY.ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIALFOR MONITORING THE PERFORMANCE OF THE HBSAG, HBSAGII AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBSAG QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG OR HBSAG CONFIRMATORY ASSAYS.
P110042||BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|||Y|12/23/2011|09/28/2012|12M-1048|11/01/2012|APPR|APPROVAL FOR THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THIS DEVICE IS INDICATED TO PROVIDE DEFIBRILLATION THERAPY FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS INPATIENTS WHO DO NOT HAVE SYMPTOMATIC BRADYCARDIA, INCESSANT VENTRICULAR TACHYCARDIA, OR SPONTANEOUS, FREQUENTLY RECURRING VENTRICULAR TACHYCARDIA THAT IS RELIABLY TERMINATED WITH ANTITACHYCARDIA PACING.
P110043||ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|||N|12/30/2011|07/31/2012|12M-0833|08/03/2012|APPR|APPROVAL FOR THE OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC ILIAC ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS OF >= 5.0 MM AND <= 11.0 MM AND LESION LENGTHS UP TO 50 MM.
P120002||CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS|NIP|CV|||N|02/03/2012|11/07/2012|12M-1183|12/05/2012|APPR|APPROVAL FOR THE S.M.A.R.T. CONTROL AND S.M.A.R.T. VASCULAR STENT SYSTEMS. THIS DEVICE IS INDICATED FOR USE TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF PATIENTS WITH DE NOVO OR RESTENOTIC NATIVE LESION(S) OF THE SUPERFICIAL FEMORAL ARTERY AND/OR PROXIMAL POPLITEAL ARTERY WITH TOTAL LENGTH UP TO 150 MM AND WITH A REFERENCE VESSEL DIAMETER RANGING FROM 4 MM TO 7 MM.
P120004||PARASCRIPT, LLC|6273 MONARCH PARK PLACE||LONGMONT|CO|80503||Analyzer,medical image|PARASCRIPT ACCUDETECT 6.1.0|MYN|RA|||N|03/30/2012|08/22/2013|13M-1017|09/10/2013|APPR|APPROVAL FOR THE PARASCRIPT® ACCUDETECT® 6.1.0. THIS DEVICE IS INDICATED FOR USE IN SCREENING MAMMOGRAPHY TO IDENTIFY AREAS SUSPICIOUS FOR BREAST CANCER FOR RADIOLOGIST REVIEW AFTER COMPLETING AN INITIAL READ.
P120005||DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|||N|04/09/2012|10/05/2012|12M-1049|10/12/2012|APPR|APPROVAL FOR THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS DEVICE IS INDICATED FOR:THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.THE DEXCOM G4 PLATINUM SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.  THE DEXCOM G4 PLATINUM SYSTEM AIDS IN THE DETECTION OF EPISODES OFHYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G4 PLATINUM SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P120006||TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|||N|04/11/2012|10/05/2012|12M-1110|11/08/2012|APPR|APPROVAL FOR THE OVATION ABDOMINAL STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINALAORTIC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:  1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES; 2) NON-ANEURYSMAL PROXIMAL AORTIC NECK:  A) WITH A LENGTH OF AT LEAST 7 MM PROXIMAL TO THE ANEURYSM; B) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM; AND C) WITH AN AORTIC ANGLE OF <= 60 DEGREES IF PROXIMAL NECK IS >= 10 MM AND <=45 DEGREES IF PROXIMAL NECK IS <10 MM. 3) ADEQUATE DISTAL ILIAC LANDING ZONE: A) WITH A LENGTH OF AT LEAST 10 MM; AND WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 20 MM.
P120007||GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV 16 18/45 GENOTYPE ASSAY|OYB|MI|||N|04/19/2012|10/12/2012|12M-1066|11/01/2012|APPR|APPROVAL FOR THE APTIMA HPV 16 18/45 GENOTYPE ASSAY.APTIMA HPV 16 18/45 GENOTYPE ASSAY INDICATIONS FOR USE:THE APTIMA HPV 16 18/45 GENOTYPE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) OF HUMAN PAPILLOMAVIRUS (HPV) TYPES 16, 18, AND 45 IN CERVICAL SPECIMENS FROM WOMEN WITH APTIMA HPV ASSAY POSITIVERESULTS.  THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN DIFFERENTIATE HPV 16 FROM HPV 18 AND/OR HPV 45, BUT DOES NOT DIFFERENTIATE BETWEEN HPV 18 AND HPV 45. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE ORCYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV 16 18/45 GENOTYPE ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM.  THE USE OF THE TEST IS INDICATED:  1) IN PATIENTS 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE(ASC-US) CERVICAL CYTOLOGY RESULTS, THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN BE USED TO TEST SAMPLES FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV GENOTYPES 16, 18, AND/OR 45. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY; AND 2) IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN BE USED TO TEST SAMPLES FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS. THE ASSAY RESULTS WI11 BE USED IN COMBINATION WITH CERVICAL CYTOLOGY TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV GENOTYPES 16, 18, AND/OR 45. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT * BROOM-TYPE DEVICE (E.G., WALLACH PIPETTE), OR ENDOCERVICAL BRUSH/SPATULA.
P120008||Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT ARCHITECT AFP ASSAY|LOK|IM|||N|05/01/2012|11/28/2012|12M-1176|12/05/2012|APPR|APPROVAL FOR THE ARCHITECT AFP ASSAY, ARCHITECT AFP CALIBRATORS AND ARCHITECT AFP CONTROLS. THIS DEVICE IS INDICATED FOR:THE ARCHITECT AFP ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN:1) HUMAN SERUM OR PLASMA TO AID IN MONITORING DISEASE PROGRESSION DURING THE COURSE OF DISEASE AND TREATMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER; AND 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD.  THE ARCHITECT AFP CALIBRATORS ARE FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID. THE PERFORMANCE OF THE ARCHITECT AFP CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER AFP ASSAYS.  THE ARCHITECT AFP CONTROLS ARE FOR THE ESTIMATION OF TEST PRECISION AND THE DETECTION OF SYSTEMATIC ANALYTICAL DEVIATIONS OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID. THE PERFORMANCE OF THE ARCHITECT AFP CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER AFP ASSAYS.
P120009||PFM MEDICAL, INC|1815 ASTON AVE|SUITE 106|CARLSBAD|CA|92008||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|NIT-OCCLUD PDA|MAE|CV|||N|05/04/2012|08/16/2013|13M-0988|08/26/2013|APPR|APPROVAL FOR THE NIT-OCCLUD® PDA. THIS DEVICE IS A PERMANENTLY IMPLANTED PROSTHESIS INDICATED FOR PERCUTANEOUS, TRANSCATHETER CLOSURE OF SMALL TO MODERATE SIZE PATENT DUCTUS ARTERIOSUS WITH A MINIMUMANGIOGRAPHIC DIAMETER LESS THAN 4 MM.
P120010||MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|||Y|06/05/2012|09/26/2013|13M-1206|09/30/2013|APPR|APPROVAL FOR THE MINIMED 5300 SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING:MINIMED 530G SYSTEM - THE MINIMED 530G SYSTEM IS INTENDED FOR CONTINUOUS DELIVERY OF BASAL INSULIN (AT USER SELECTABLE RATES) AND ADMINISTRATION OF INSULIN BOLUSES (IN USER SELECTABLE AMOUNTS) FOR THEMANAGEMENT OF DIABETES MELLITUS IN PERSONS, SIXTEEN YEARS OF AGE AND OLDER, REQUIRING INSULIN AS WELL AS FOR THE CONTINUOUS MONITORING AND TRENDING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN. THE MINIMED 530G SYSTEM CAN BE PROGRAMMED TO AUTOMATICALLY SUSPEND DELIVERY OF INSULIN WHEN THE SENSOR GLUCOSE VALUE FALLS BELOW A PREDEFINED THRESHOLD VALUE. FOR ADDITIONAL INFORMATION PLEASE REFER TO APPROVAL ORDER.
P120011||IDEALIMPLANT|5005 LBJ FREEWAY SUITE 900||DALLAS,|TX|75244||Prosthesis, breast, inflatable, internal, saline|IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT|FWM|SU|||N|06/25/2012|11/14/2014|14M-2042|11/25/2014|APPR|APPROVAL FOR THE IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT. THIS DEVICE IS INDICATED FOR WOMEN AT LEAST 18 YEARS OLD UNDERGOING:1) PRIMARY BREAST AUGMENTATION TO INCREASE BREAST SIZE; AND 2) REVISION BREAST AUGMENTATION TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY.
P120012||ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)|OBF|MI|||N|07/12/2012|06/20/2013|13M-0758|06/24/2013|APPR|APPROVAL FOR THE ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, AND URACIL-GLYCOSYLASE(UNG). THIS DEVICE IS INDICATED FOR:  ABBOTT REALTIME HCV GENOTYPE IITHE ABBOTT REALTIME HCV GENOTYPE II IS AN IN VITRO REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR USE WITH THE ABBOTT MSAMPLE PREPARATION SYSTEM REAGENTS AND WITH THE ABBOTT M2000SP AND M2000RT INSTRUMENTS FOR THE QUALITATIVE IDENTIFICATION OFHEPATITIS C VIRUS (HCV) GENOTYPES 1, 1A, 1B, AND 2 - 5 IN PLASMA OR SERUM FROM INDIVIDUALS CHRONICALLY INFECTED WITH HCV.THE ABBOTT REALTIME HCV GENOTYPE II IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED INDIVIDUALS AND IN GUIDING THE SELECTION OF THERAPEUTIC TREATMENT INDICATED FOR THE ABOVE LISTED GENOTYPES. THE ASSAY IS INTENDED FOR USE ON PATIENTS WHO ARE CHRONICALLY INFECTED WITH HCV, ARE BEING CONSIDERED FOR ANTIVIRAL TREATMENT, AND ARE POSITIVE FOR HCV RNA. THE ABBOTT REALTIME HCV GENOTYPE II ASSAY IS NOT FOR SCREENING BLOOD, PLASMA, SERUM OR TISSUE DONORS FOR HCV.  ABBOTT REALTIME HCV GENOTYPE II CONTROL KITTHE ABBOTT REALTIME HCV GENOTYPE II CONTROLS ARE USED TO ESTABLISH RUN VALIDITY OF THE ABBOTT REALTIME HCV GENOTYPE II ASSAY WHEN USED FOR DETERMINING THE GENOTYPE(S) OF HEPATITIS C VIRUS (HCV) IN PLASMA OR SERUM FROM INDIVIDUALS CHRONICALLY INFECTED WITH HCV.  URACIL-N-GLYCOSYLASE (UNG) THE URACIL-N-GLYCOSYLASE (UNG) PROCEDURE IS TO BE USED IN CONJUNCTION WITH ABBOTT REALTIME HCV GENOTYPE II ASSAY AS AN OPTIONAL CONTAMINATION CONTROL FOR CUSTOMER LABORATORIES THAT ARE CURRENTLY USING OR HAVE PREVIOUSLY USED AMPLIFICATION TECHNOLOGIES THATINCORPORATE URACIL INTO THE AMPLIFICATION PRODUCT.
P120014||bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||Somatic gene mutation detection system|BIOMERIEUX THXID BRAF ASSAY KIT|OWD|PA|||Y|07/31/2012|05/29/2013|13M-0709|06/14/2013|APPR|APPROVAL FOR THE THXID BRAF KIT FOR USE ON THE ABI 7500 FAST DX REAL-TIME PCR INSTRUMENT. THIS DEVICE IS INDICATED FOR: THE THXID BRAF KIT IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION OF THE BRAF V600E AND V600K MUTATIONS IN DNA SAMPLES EXTRACTED FROM FORMALIN-FIXED PARAFFINEMBEDDED (FFPE) HUMAN MELANOMA TISSUE. THE THXID BRAF KIT IS A REAL-TIME PCR TEST ON THE ABI 7500 FAST DX SYSTEM AND IS INTENDED TO BE USED AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E MUTATION FOR TREATMENT WITH DABRAFENIB [TAFINLAR®] AND AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E OR V600K MUTATION FOR TREATMENT WITH TRAMETINIB [MEKINIST].
P120016||CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|||N|08/03/2012|01/31/2013|13M-0592|05/17/2013|APPR|APPROVAL FOR THE VASCADE¿ VASCULAR CLOSURE SYSTEM (VCS). THIS DEVICE IS INDICATED FOR FEMORAL ARTERIAL ACCESS SITE CLOSURE WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVEUNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F, 6F, OR 7F PROCEDURAL SHEATH. THE VASCADE VCS IS ALSO INDICATED TO REDUCE TIME TO DISCHARGE ELIGIBILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR PROCEDURES USING A 5F, 6F, OR 7F PROCEDURAL SHEATH.
P120017||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MODEL 5071 LEAD|DTB|CV|||N|10/04/2012|04/27/2015|15M-1461|05/08/2015|APPR|APPROVAL FOR UNIPOLAR VENTRICULAR PACING AND SENSING. THE LEAD HASAPPLICATION WHERE PERMANENT VENTRICULAR OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED. TWO LEADS MAY BE USED FOR BIPOLAR PACING.
P120018||SHARPS TERMINATOR, LLC|6502 SLIDE RD SUITE 402||LUBBOCK|TX|79401||Device, needle destruction|SHARPS TERMINATOR|MTV|HO|||N|10/23/2012|02/17/2016|16M-0806|03/07/2016|APPR|Approval for the Sharps Terminator.  This device is indicated for use by individuals and healthcare professionals to safely destroy 18-27 gauge needles up to 2 inches (approx. 5 cm). The device is for use in treatment settings such as treatment rooms, emergency/trauma rooms, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, Dental Offices, and Clinical Laboratories.
P120019||ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|||Y|11/08/2012|05/14/2013|13M-0594|05/17/2013|APPR|APPROVAL FOR THE COBAS® EGFR MUTATION TEST.  THE COBAS® EGFR MUTATION TEST IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OFTHE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPET) HUMAN NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED AS AN AID IN SELECTING PATIENTS WITH METASTATIC NSCLC FOR WHOM TARCEVA® (ERLOTINIB), AN EGFR TYROSINE KINASE INHIBITOR (TK1), IS INDICATED. SPECIMENS ARE PROCESSED USING THE COBAS® DNA SAMPLE PREPARATION KIT FOR MANUAL SAMPLE PREPARATION AND THE COBAS Z 480 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION.
P120020||ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|||N|11/16/2012|03/28/2014|14M-0434|04/21/2014|APPR|APPROVAL FOR THE SUPERA® PERIPHERAL STENT SYSTEM.  THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC DE NOVO OR RESTENOTIC NATIVE LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY, WITH REFERENCE VESSEL DIAMETERS OF 4.0 TO 6.5 MM, AND LESION LENGTHS UP TO 140 MM.
P120021||St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER PFO OCCLUDER|MLV|CV|||N|11/30/2012|10/28/2016|16M-3653|11/01/2016|APPR|Approval for the AMPLATZER PFO Occluder.  The device is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.
P120022||QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN EGFR RGQ PCR KIT|OWD|PA|||Y|11/30/2012|07/12/2013|13M-0851|07/15/2013|APPR|APPROVAL FOR THE THERASCREEN® EGFR RGQ PCR KIT. THIS DEVICE IS INDICATED FOR: THE THERASCREEN® EGFR RGQ PCR KIT IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) NONSMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED TO SELECT PATIENTS WITH NSCLC FOR WHOM GILOTRJF (AFATINIB), AN EGFR TYROSINE KINASE INHIBITOR (TKI), IS INDICATED. SAFETY AND EFFICACY OF GILOTRIF (AFATINIB) HAVE NOT BEEN ESTABLISHED IN PATIENTS WHOSE TUMORS HAVE L861Q, G719X, 87681, EXON 20 INSERTIONS, AND T790M MUTATIONS, WHICH ARE ALSO DETECTED BY THE THERASCREEN® EGFR RGQ PCR KIT.  SPECIMENS ARE PROCESSED USING THE QIAAMP® DSP DNA FFPE TISSUE KIT FOR MANUAL SAMPLE PREPARATION AND THE ROTOR-GENE® Q MDX INSTRUMENT FOR AUTOMATED AMPLIFICATION ANDDETECTION.
P120023||ACUFOCUS, INC.|32 DISCOVERY|SUITE 200|IRVINE|CA|92618||Implant, corneal, refractive|KAMRA INLAY|LQE|OP|||N|12/12/2012|04/17/2015|15M-1326|04/29/2015|APPR|APPROVAL FOR THE KAMRA INLAY. THE KAMRA INLAY IS INDICATED FOR INTRASTROMAL CORNEAL IMPLANTATION TO IMPROVE NEAR VISION BY EXTENDING THE DEPTH OF FOCUS IN THE NON-DOMINANT EYE OF PHAKIC, PRESBYOPIC PATIENTS BETWEEN THE AGES OF 45 AND 60 YEARS OLD WHO HAVE CYCLOPLEGIC REFRACTIVE SPHERICAL EQUIVALENT OF +0.50 D TO -0.75 D WITH LESS THAN OR EQUAL TO 0.75 D OF REFRACTIVECYLINDER, WHO DO NOT REQUIRE GLASSES OR CONTACT LENSES FOR CLEAR DISTANCE VISION, AND WHO REQUIRE NEAR CORRECTION OF +1.00 D TO +2.50 D OF READING ADD.
P120024||AESCULAP IMPLANT SYSTEMS, LLC|3773 Corporate Parkway||Center Valley|PA|18034||PROSTHESIS, INTERVERTEBRAL DISC|ACTIVL ARTIFICIAL DISC|MJO|OR|||N|12/18/2012|06/11/2015|15M-2218|07/17/2015|APPR|APPROVAL FOR THE ACTIVL® ARTIFICIAL DISC. THIS DEVICE IS INDICATED FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL (L4-L5 OR L5-S1) FOLLOWING SINGLE-LEVEL DISCECTOMY IN SKELETALLY MATURE PATIENTS WITH SYMPTOMATIC DEGENERATIVE DISC DISEASE (DDD) WITH NO MORE THAN GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, PHYSICAL EXAMINATION, AND RADIOGRAPHIC STUDIES. THE ACTIVL® ARTIFICIAL DISC IS IMPLANTED USING AN ANTERIOR RETROPERITONEAL APPROACH. PATIENTS RECEIVING THE ACTIVL® ARTIFICIAL DISC SHOULD HAVE FAILED AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE DEVICE.
P130001||EPIGENOMICS AG|GENESTSTR.5||BERLIN||||System, colorectal neoplasia, DNA methylation and hemoglobin detection|Epi proColon|PHP|PA|||Y|01/03/2013|04/12/2016|16M-1168|05/20/2016|APPR|The Epi proColon test is a qualitative in vitro diagnostic test for the detection of methylated Septin 9 DNA in EDTA plasma derived from patient whole blood specimens. Methylation of the target DNA sequence in the promoter region of the SEPT9_v2 transcript has been associated with the occurrence of colorectal cancer (CRC). The test uses a real-time polymerase chain reaction (PCR) with a fluorescent hydrolysis probe for the methylation specific detection of the Septin 9 DNA target.  The Epi proColon test is indicated to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered and declined prior to offering the Epi proColon test. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results should be used in combination with physician's assessment and individual risk factors in guiding patient management.
P130004||OCULAR THERAPEUTICS, INC.|36 CROSBY DR SUITE 101||BEDFORD|MA|01730||Ophthalmic Sealant|RESURE SEALANT|PFZ|OP|||N|02/01/2013|01/08/2014|14M-0069|01/15/2014|APPR|APPROVAL FOR THE RESURE® SEALANT. THIS DEVICE IS INDICATED FOR INTRAOPERATIVE MANAGEMENT OF CLEAR CORNEAL INCISIONS (UP TO 3.5MM) WITH A DEMONSTRATED WOUND LEAK FOR WHICH A TEMPORARY DRY SURFACE CAN BE ACHIEVED, IN ORDER TO PREVENT POSTOPERATIVE FLUID EGRESS FROM SUCH INCISIONS FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) PLACEMENT IN ADULTS.
P130005||CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM|MCX|CV|||N|03/15/2013|10/21/2013|13M-1363|10/30/2013|APPR|APPROVAL FOR THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS). THE DEVICE IS INDICATED TO FACILITATE STENT DELIVERY IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) WHO ARE ACCEPTABLE CANDIDATES FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OR STENTING DUE TO DE NOVO, SEVERELY CALCIFIED CORONARY ARTERY LESIONS.
P130006||W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|||N|04/01/2013|12/05/2013|13M-1605|12/24/2013|APPR|APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS AND THE GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THIS DEVICE IS INDICATED FOR THE TREATMENT OF STENOSIS OR THROMBOTIC OCCLUSION AT THE VENOUS ANASTOMOSIS OF SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFTS.
P130007||ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|||N|04/17/2013|11/25/2014|14M-2246|12/18/2014|APPR|APPROVAL FOR THE ANIMAS VIBE SYSTEM. THIS DEVICE IS INDICATED FOR:THE ANIMAS® VIBE¿ SYSTEM CONSISTS OF THE ANIMAS® VIBE¿ INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER.THE ANIMAS® VIBE¿ INSULIN PUMP IS INDICATED FOR CONTINUOUS SUBCUTANEOUS INSULIN INFUSION FOR THE MANAGEMENT OF INSULIN-REQUIRING DIABETES. IT CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY AND AS PART OF THE ANIMAS® VIBE¿ SYSTEM TO RECEIVE AND DISPLAY CONTINUOUS GLUCOSE MEASUREMENTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER.THE ANIMAS® VIBE¿ SYSTEM'S CONTINUOUS GLUCOSE MONITORING (CGM) IS INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES, AND IS INTENDED TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. CGM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF RESULTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.  THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.
P130008||INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATOR|MNQ|AN|||N|05/01/2013|04/30/2014|14M-0690|05/29/2014|APPR|APPROVAL FOR THE INSPIRE UPPER AIRWAY STIMULATION (UAS) SYSTEM, WHICH INCLUDES THE MODEL 3024 IMPLANTABLE PULSE GENERATOR, THE MODEL 4063 STIMULATION LEAD, THE MODEL 4323 SENSING LEAD, THE MODEL 2740PHYSICIAN PROGRAMMER, AND THE MODEL 3032 PATIENT PROGRAMMER. THE DEVICE IS USED TO TREAT A SUBSET OF PATIENTS WITH MODERATE TO SEVERE OBSTRUCTIVE SLEEP APNEA (OSA) (APNEA-HYPOPNEA INDEX [AHI] OF GREATER OR EQUAL TO 20 AND LESS THAN OR EQUAL TO 65). INSPIRE UAS IS USED IN ADULT PATIENTS 22 YEARS OF AGE AND OLDER WHO HAVE BEEN CONFIRMED TO FAIL OR CANNOT TOLERATE POSITIVE AIRWAY PRESSURE (PAP) TREATMENTS (SUCH AS CONTINUOUS POSITIVE AIRWAY PRESSURE [CPAP] OR BILEVEL POSITIVE AIRWAY PRESSURE [BPAP] MACHINES) AND WHO DO NOT HAVE A COMPLETE CONCENTRIC COLLAPSE AT THE SOFT PALATE LEVEL.  PAP FAILURE IS DEFINED AS AN INABILITY TO ELIMINATE OSA (AHI OF GREATER THAN 20 DESPITE PAP USAGE) AND PAP INTOLERANCE IS DEFINED AS: 1) INABILITY TO USE PAP (GREATER THAN 5 NIGHTS PER WEEK OF USAGE; USAGE DEFINED AS GREATER THAN 4 HOURS OF USE PER NIGHT); OR 2) UNWILLINGNESS TO USE PAP (FOR EXAMPLE, A PATIENT RETURNS THE PAP SYSTEM AFTER ATTEMPTING TO USE IT).
P130009||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|||N|05/02/2013|06/16/2014|14M-0874|07/15/2014|APPR|APPROVAL FOR THE SAPIEN XT TRANSCATHETER HEART VALVE (THV), MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS (AORTIC VALVE AREA <=1.0 CM2 OR AORTIC VALVE AREA INDEX <=0.6 CM2/M2, A MEAN AORTIC VALVE GRADIENT OF >= 40 MMHG, OR A PEAK AORTIC-JET VELOCITY OF >= 4.0 M/S), AND WITH NATIVE ANATOMY APPROPRIATE FOR THE 23, 26, OR 29 MM VALVE SYSTEM, WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >=8% OR AT A >=15% RISK OF MORTALITY AT 30 DAYS).
P130012||Greatbatch Medical|2300 BERKSHIRE LANE NORTH||MINNEAPOLIS|MN|55441||permanent pacemaker Electrode|MYOPORE SUTURELESS MYOCARDIAL PACING LEAD|DTB|CV|||N|05/13/2013|04/30/2015|15M-1557|05/08/2015|APPR|APPROVAL FOR THE MYOPORE SUTURELESS MYOCARDIAL PACING LEAD. THIS DEVICE IS INDICATED FOR WHEN VENTRICULAR EPICARDIAL ATTACHMENT IS REQUIRED, OR WHEN A TRANSVENOUS LEAD CANNOT PROVIDE EFFECTIVE PACING. THIS TYPE OF LEAD IS USEFUL IN SITUATIONS WHERE IT IS REQUIRED THAT THE POTENTIAL FOR LEAD DISLODGEMENT BE DIMINISHED OR PACING AND/OR SENSING WILL BE ESTABLISHED SUBSEQUENT TO OPEN HEART SURGERY.
P130011||LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|FREEDOM SOLO STENTLESS HEART VALVE|LWR|CV|||N|05/13/2013|06/24/2014|14M-1064|07/23/2014|APPR|APPROVAL FOR THE FREEDOM SOLO STENTLESS HEART VALVE AND SOLO SMART STENTLESS HEART VALVE. THESE DEVICES ARE INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETICAORTIC VALVES.
P130013||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY|NGV|CV|||Y|05/14/2013|03/13/2015|15M-0910|03/13/2015|APPR|APPROVAL FOR THE WATCHMAN LAA CLOSURE TECHNOLOGY. THIS DEVICE IS INDICATED TO REDUCE THE RISK OF THROMBOEMBOLISM FROM THE LEFT ATRIAL APPENDAGE (LAA) IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION WHO: ARE AT INCREASED RISK FOR STROKE AND SYSTEMIC EMBOLISM BASED ON CHADS2 OR CHA2DS2-VASC SCORES AND ARE RECOMMENDED FOR ANTICOAGULATION THERAPY;  ARE DEEMED BY THEIR PHYSICIANS TO BE SUITABLE FOR WARFARIN; AND HAVE AN APPROPRIATE RATIONALE TO SEEK A NON-PHARMACOLOGIC ALTERNATIVE TO WARFARIN, TAKING INTO ACCOUNT THE SAFETY AND EFFECTIVENESS OF THE DEVICE COMPARED TO WARFARIN.
P130014||HYPERBRANCH MEDICAL TECHNOLOGY, INC.|800-12 Capitola Drive||Durham|NC|27713||Sealant, dural|ADHERUS AUTOSPRAY DURAL SEALANT|NQR|NE|||N|05/14/2013|03/30/2015|15M-1065|04/17/2015|APPR|APPROVAL FOR THE ADHERUS AUTOSPRAY DURAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE 13 YEARS OF AGE AND OLDER, AS AN ADJUNCT TO STANDARD METHODS OF DURAL REPAIR, SUCH AS WHEN USING SUTURES, TO PROVIDEWATERTIGHT CLOSURE DURING CRANIAL PROCEDURES.
P130015||ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG|LOM|MI|||N|05/30/2013|03/14/2014|14M-0326|03/31/2014|APPR|APPROVAL FOR THE ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG. THIS DEVICE IS INDICATED FOR:ELECSYS HBEAG IMMUNOASSAYTHE ELECSYS HBEAG IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN SERUM OR PLASMA (K2-EDTA, LITHIUM OR SODIUM HEPARIN, AND SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION. THE ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B OR RECOVERY FROM HEPATITIS B INFECTION.  THE ELECTROCHEMILUMIN-ESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE MODULAR ANALYTICS E170 ANALYZER.ELECSYS PRECICONTROL HBEAG ELECSYS PRECICONTROL HBEAG IS USED FOR QUALITY CONTROL OF THE ELECSYS HBEAG IMMUNOASSAY ON THE MODULAR ANALYTICS E170 ANALYZER.
P130016||Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|||Y|06/03/2013|03/20/2014|14M-0327|04/10/2014|APPR|APPROVAL FOR THE NUCLEUS® HYBRID L24 COCHLEAR IMPLANT SYSTEM. THE NUCLEUS® HYBRID L24 COCHLEAR IMPLANT SYSTEM IS INTENDED TO PROVIDE ELECTRIC STIMULATION TO THE MID-TO-HIGH FREQUENCY REGION OF THE COCHLEA AND ACOUSTIC AMPLIFICATION TO THE LOW FREQUENCY REGIONS, FOR PATIENTS WITH RESIDUAL LOW FREQUENCY HEARING SENSITIVITY.  THE SYSTEM IS INDICATED FOR UNILATERAL USE IN PATIENTS AGED 18 YEARS AND OLDER WHO HAVE RESIDUALLOW-FREQUENCY HEARING SENSITIVITY AND SEVERE TO PROFOUND HIGH FREQUENCY SENSORINEURAL HEARING LOSS, AND WHO OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FIT BILATERAL HEARING AIDS. TYPICAL PREOPERATIVE HEARING OF CANDIDATES RANGES FROM NORMAL TO MODERATE HEARING LOSS IN THE LOW FREQUENCIES (THRESHOLDS NO POORER THAN 60 DB HL UP TO AND INCLUDING 500 HZ), WITH SEVERE TO PROFOUND MID TO HIGH FREQUENCY HEARING LOSS (THRESHOLD AVERAGE OF 2000, 3000, AND 4000 HZ >=75 DB HL) IN THE EAR TO BE IMPLANTED, AND MODERATELY SEVERE TO PROFOUND MID TO HIGH FREQUENCY HEARING LOSS (THRESHOLD AVERAGE OF 2000, 3000, AND 4000 HZ >=60 DB HL) IN THE CONTRALATERAL EAR.  THE CNC WORD RECOGNITION SCORE WILL BE BETWEEN 10% AND 60%, INCLUSIVELY, IN THE EAR TO BE IMPLANTED IN THE PREOPERATIVE AIDED CONDITION AND IN THE CONTRALATERAL EAR WILL BE EQUAL TO OR BETTER THAN THAT OF THE EAR TO BE IMPLANTED BUT NOT MORE THAN 80% CORRECT. PROSPECTIVE CANDIDATES SHOULDGO THROUGH A SUITABLE HEARING AID TRIAL, UNLESS ALREADY APPROPRIATELY FIT WITH HEARING AIDS.
P130017||Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|||N|06/07/2013|08/11/2014|14M-1193|08/13/2014|APPR|APPROVAL FOR THE COLOGUARD.  COLOGUARD IS INTENDED FOR THE QUALITATIVE DETECTION OF COLORECTAL NEOPLASIA ASSOCIATED DNA MARKERS AND FOR THE PRESENCE OF OCCULT HEMOGLOBIN IN HUMAN STOOL. A POSITIVE RESULT MAY INDICATE THE PRESENCE OF COLORECTAL CANCER (CRC) OR ADVANCED ADENOMA (AA) AND SHOULD BE FOLLOWED BY DIAGNOSTIC COLONOSCOPY. COLOGUARD IS INDICATED TO SCREEN ADULTS OF EITHER SEX, 50 YEARS OR OLDER, WHO ARE AT TYPICAL AVERAGE-RISK FOR CRC. COLOGUARD IS NOT A REPLACEMENT FOR DIAGNOSTIC COLONOSCOPY OR SURVEILLANCE COLONOSCOPY IN HIGH RISK INDIVIDUALS.
N970003||Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE|LWP|CV|||N|09/08/1997|06/03/1999|||APPR|APPROVAL FOR YOUR PRODUCT DEVELOPMENT PROTOCOL (PDP) FOR THE:GUIDANT PULSAR MODELS 470, 970, 972, 1172, 1272 PULSE GENERATORS, GUIDANT PULSAR MAX MODELS 1170, 1171, 1270 PULSE GENERATORS, AND GUIDANT CONSULT  (MODEL 2890) SOFTWARE.GUIDANT PULSAR/PULSAR  MAX SERIES PACEMAKERS ARE INDICATED FOR THE FOLLOWING: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND. OR THIRD-DEGREE AV BLOCK SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCKSYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS (EG, SINUS BRADYCARDIA, SINUS ARREST, SINOATRIAL [SA] BLOCK) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS NEUROVASCULAR  (VASOVAGAL) SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES ADAPTIVE-RATE PACING IS INDICATED FOR PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR LEVEL OF PHYSICAL ACTIVITY.  THE PULSAR¿/PULSAR  MAX¿ SERIES PACEMAKERS' DUAL CHAMBER AND ATRIAL TRACKING MODES ARE ALSO INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. 	DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF THE FOLLOWING:CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF AV SYNCHRONY, INCLUDING VARYING DEGREES OF 	AV BLOCK VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM LOW CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE SECONDARY TO BRADYCARDIA.
N970012||Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES|JCW|GU|||N|12/22/1997|11/02/1998|||APPR|APPROVAL FOR THE AMS 700 SERIES INFLATABLE PENILE PROSTHESIS PRODUCT LINE. THIS DEVICE IS INDICATED FOR USE IN THE TREATMENT OF CHRONIC, ORGANIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE).
N980003||DJO SURGICAL|9800 METRIC BOULEVARD||AUSTIN|TX|78758||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM|MRA|OR|||N|03/08/1998|11/26/2003|||APPR|APPROVAL FOR THE PRODUCT DEVELOPMENT PROTOCOL (PDP) FOR THE KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM.  THIS DEVICE IS INDICATED FOR USC IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY FOR THE TREATMENT OF INFLAMMATORY TISSUE DISORDERS AND NONINFLAMMATORY DEGENERATIVE JOINT DISEASE, INCLUDING OSTEOARTHRITIS,  POST-TRAUMATIC ARTHRITIS OR SECONDARY ARTHRITIS, AND AVASCULAR NECROSIS.
P130018||UROMEDICA INC|1840 BERKSHIRE LANE N||PLYMOUTH|MN|55441||Device, incontinence, mechanical/hydraulic|PROACT ADJUSTABLE INCONTINENCE THERAPY FOR MEN|EZY|GU|||N|06/17/2013|11/24/2015|||APPR|APPROVAL FOR THE PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ADULT MEN WHO HAVE STRESS INCONTINENCE ARISING FROM INTRINSIC SPHINCTER DEFICIENCY OF AT LEAST TWELVE MONTHS DURATION FOLLOWING RADICAL PROSTATECTOMY OR TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AND WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE THERAPY.
P130019||ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|||N|06/21/2013|01/14/2015|15M-0201|01/16/2015|APPR|APPROVAL FOR THE MAESTRO® RECHARGEABLE SYSTEM. THIS DEVICE IS INDICATED FOR USE IN WEIGHT REDUCTION IN PATIENTS AGED 18 YEARS THROUGH ADULTHOOD WHO HAVE A BODY MASS INDEX (BMI) OF 40 TO 45 KG/M2, OR A BMI OF 35 TO 39.9 KG/M2 WITH ONE OR MORE OBESITY RELATED CO-MORBID CONDITIONS, AND HAVE FAILED AT LEAST ONE SUPERVISED WEIGHT MANAGEMENT PROGRAM WITHIN THE PAST FIVE YEARS.
P130020||GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Digital breast tomosynthesis|SENOCLAIRE|OTE|RA|||N|07/17/2013|08/26/2014|14M-1279|09/02/2014|APPR|APPROVAL FOR THE SENOCLAIRE.  THIS DEVICE IS INDICATED FOR THE ACQUISITION OF 2D IMAGES AND ALSO FOR THE ACQUISITION OF MULTIPLE PROJECTION VIEWS INTENDED TO PRODUCE 3D DBT IMAGES SUITABLE FOR SCREENING AND DIAGNOSIS OF BREAST CANCER.  SENOCLAIRE CAN BE USED FOR THE SAME CLINICAL APPLICATIONS AS TRADITIONAL MAMMOGRAPHY FOR SCREENING MAMMOGRAPHY.  A SCREENING EXAMINATION WILL CONSIST OF:1) 2D IMAGE SET CONSISTING OF A CRANIOCAUDAL VIEW AND OF A MEDIOLATERAL OBLIQUE VIEW, OR 2) A 2D CRANIOCAUDAL VIEW AND 3D MEDIOLATERAL OBLIQUE IMAGE SET.THE SENOCLAIRE DIGITAL BREAST TOMOSYNTHESIS (DBT) OPTION TO SENOGRAPHE ESSENTIAL FFDM SYSTEM MAY ALSO BE USED FOR ADDITIONAL DIAGNOSTIC WORKUP OF THE BREAST.
P130021||MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE SYSTEM|NPT|CV|||N|07/22/2013|01/17/2014|14M-0166|02/04/2014|APPR|Approval for the Medtronic CoreValve™ System.  This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ? 0.8 cm2, a mean aortic valve gradient of > 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity ? 50% at 30 days).
P130022||NEVRO CORPORATION|1800 BRIDGE PARKWAY||REDWOOD CITY|CA|94065||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|||N|10/02/2013|05/08/2015|15M-1709|05/13/2015|APPR|APPROVAL FOR THE NEVRO SENZA SCS SYSTEM. THIS DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THEFOLLOWING: FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN, AND LEG PAIN.
P130023||COHERA MEDICAL, INC|209 SANDUSKY STREET||PITTSBURG|PA|15212||Tissue adhesive for internal use|COHERA MEDICAL TISSUGLU|PJK|SU|||N|11/12/2013|02/03/2015|15M-0431|02/04/2015|APPR|APPROVAL FOR THE TISSUGLU® SURGICAL ADHESIVE. THIS DEVICE IS INDICATED FOR THE APPROXIMATION OF TISSUE LAYERS WHERE SUBCUTANEOUS DEAD SPACE EXISTS BETWEEN THE TISSUE PLANES IN ABDOMINOPLASTY.
P130025||KONING CORPORATION|150 Lucius Gordon Drive|Suite 112|W Henrietta|NY|14586||Cross-sectional mammographic xray system|KONING BREAST CT (MODEL CBCT1000)|OLQ|RA|||N|11/25/2013|01/14/2015|15M-0200|02/09/2015|APPR|APPROVAL FOR THE KONING BREAST CT (MODEL CBCT 1000). THIS DEVICE IS INDICATED AS FOLLOWS: KONING BREAST CT (CBCT1000) IS A CONE BEAM COMPUTED TOMOGRAPHY SYSTEM INTENDED TO PROVIDE THREE DIMENSIONAL IMAGES FOR DIAGNOSTIC IMAGING OF THE BREAST. KONING BREAST CT SHOULD BE READ ALONG WITH STANDARD 2-VIEW MAMMOGRAPHY (CC AND MLO VIEWS).
P130024||LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX DRUG COATED BALLOON PTA CATETER|ONU|CV|||Y|11/25/2013|10/09/2014|14M-1597|10/14/2014|APPR|APPROVAL FOR THE LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (LUTONIX DCB). THIS DEVICE IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AFTER PRE-DILATATION, OF DE NOVO OR RESTENOTIC LESIONS UP TO 150MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSELDIAMETERS OF 4-6MM.
P130026||St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|||N|11/29/2013|10/24/2014|14M-1736|11/21/2014|APPR|APPROVAL FOR THE TACTICATH QUARTZ CATHETER AND TACTISYSQUARTZ® EQUIPMENT. THIS DEVICE IS INDICATED FOR USE IN CARDIACELECTROPHYSIOLOGICAL MAPPING AND FOR THE TREATMENT OF DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED IN CONJUNCTION WITH A COMPATIBLE RADIOFREQUENCY GENERATOR AND THREE-DIMENSIONAL MAPPING SYSTEM.
P130027||QIAGEN, INC.|QAIGEN STRASSE 1|40724|HILDEN||40724||Cytomegalovirus (cmv) dna quantitative assay|ARTUS CMV RGQ MDX KIT|PAB|MI|||N|12/05/2013|06/02/2014|14M-0866|06/30/2014|APPR|APPROVAL FOR THE ARTUS CMV RGQ MDX KIT. THIS DEVICE IS INDICATED FOR:  THE ARTUS CMV RGQ MDX KIT IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HUMAN CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA. THE ARTUS CMV RGQ MDX KIT IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF SOLID ORGAN TRANSPLANT PATIENTS WHO ARE UNDERGOING ANTI-CMV THERAPY. THE TEST MEASURES CMV DNA LEVELS IN EDTA PLASMA AND CAN BE USED TO ASSESS CMV VIRAL LOAD RESPONSE TO ANTIVIRAL DRUG THERAPY. THE RESULTS FROM THE ARTUS CMV RGQ MDX KIT MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.  THE ARTUS CMV RGQ MDX KIT IS CONFIGURED FOR USE WITH THE EZ1 DSP VIRUS SYSTEM (EZ1 DSP VIRUS KIT AND EZ1 ADVANCED INSTRUMENTS) FOR DNA EXTRACTION AND THE ROTOR-GENE Q MDX INSTRUMENT FOR CMV DNA AMPLIFICATION AND QUANTITATION.  THE ARTUS CMV RGQ MDX KIT IS NOT INTENDED FOR USE AS A SCREENING TEST FOR BLOOD OR BLOOD PRODUCTS.
P130028||Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|||N|12/16/2013|11/20/2015|15M-4434|11/30/2015|APPR|APPROVAL FOR THE ALGOVITA SPINAL CORD STIMULATION SYSTEM. THIS DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P130029||BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|FLUENCY PLUS ENDOVASCULAR STENT GRAFT|PFV|CV|||N|12/17/2013|06/17/2014|14M-0875|07/15/2014|APPR|APPROVAL FOR THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT. THIS DEVICE IS INDICATED FOR USE IN THE TREATMENT OF IN-STENT RESTENOSIS IN THE VENOUS OUTFLOW OF HEMODIALYSIS PATIENTS DIALYZING BY EITHER AN ARTERIOVENOUS(AV) FISTULA OR AV GRAFT.
P130030||Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE|MAF|CV|||N|12/30/2013|06/27/2014|14M-1060|07/23/2014|APPR|APPROVAL FOR THE REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH DE NOVO LESIONS <= 28 MM IN LENGTH IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER (RVD) OF >= 2.25 TO >= 4.50 MM.
P140002||TERUMO MEDICAL CORPORATION|950 ELKTON BLVD||ELKTON|MD|21921||STENT, SUPERFICIAL FEMORAL ARTERY|MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM|NIP|CV|||N|03/06/2014|05/22/2015|15M-1958|06/05/2015|APPR|APPROVAL FOR THE MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN SYMPTOMATIC PATIENTS WITH DE NOVO OR RESTENOTIC NATIVE LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4MM TO 7MM AND LESION LENGTH UP TO 150MM.
P140003||ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA|OZD|CV|||N|03/18/2014|03/23/2015|25M-1177|04/10/2015|APPR|APPROVAL FOR THE IMPELLA. THIS DEVICE IS INDICATED FOR:THE IMPELLA 2.5 SYSTEM IS A TEMPORARY (<= 6 HOURS) VENTRICULAR SUPPORT DEVICE INDICATED FOR USE DURING HIGH RISK PERCUTANEOUS CORONARY INTERVENTIONS (PCI) PERFORMED IN ELECTIVE OR URGENT, HEMODYNAMICALLY STABLE PATIENTS WITH SEVERE CORONARY ARTERY DISEASE AND DEPRESSED LEFT VENTRICULAR EJECTION FRACTION, WHEN A HEART TEAM, INCLUDING A CARDIAC SURGEON, HAS DETERMINED HIGH RISK PCI IS THE APPROPRIATE THERAPEUTIC OPTION. USE OF THE IMPELLA 2.5 IN THESE PATIENTS MAY PREVENT HEMODYNAMIC INSTABILITY WHICH CAN RESULT FROM REPEAT EPISODES OF REVERSIBLE MYOCARDIAL ISCHEMIA THAT OCCUR DURING PLANNED TEMPORARY CORONARY OCCLUSIONS AND MAY REDUCE PERI- AND POST-PROCEDURAL ADVERSE EVENTS.
P140004||VERTIFLEX (R), INCORPORATED|1351 Calle Avanzado Suite 100||San Clemente|CA|92673||Prosthesis, spinous process spacer/plate|SUPERION INTERSPINOUS SPACER|NQO|OR|||N|03/31/2014|05/20/2015|15M-1957|06/18/2015|APPR|APPROVAL FOR THE SUPERION INTERSPINOUS SPACER (ISS). THIS DEVICE IS INDICATED TO TREAT SKELETALLY MATURE PATIENTS SUFFERING FROM PAIN, NUMBNESS, AND/OR CRAMPING IN THE LEGS (NEUROGENIC INTERMITTENT CLAUDICATION) SECONDARY TO A DIAGNOSIS OF MODERATE DEGENERATIVE LUMBAR SPINAL STENOSIS, WITH OR WITHOUT GRADE 1 SPONDYLOLISTHESIS, CONFIRMED BY X-RAY, MRI AND/OR CT EVIDENCE OF THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS, AND/OR CENTRAL CANAL OR FORAMINAL NARROWING. THE SUPERION® ISS IS INDICATED FOR THOSE PATIENTS WITH IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM SYMPTOMS OF LEG/BUTTOCK/GROIN PAIN, NUMBNESS, AND/OR CRAMPING, WITH OR WITHOUT BACK PAIN, AND WHO HAVE UNDERGONE AT LEAST 6 MONTHS OF NON-OPERATIVE TREATMENT. THE SUPERION® ISS MAY BE IMPLANTED AT ONE OR TWO ADJACENT LUMBAR LEVELS IN PATIENTS IN WHOM TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS, FROM L1 TO L5. FOR THIS INTENDED USE, MODERATE DEGENERATIVE LUMBAR SPINAL STENOSIS WAS DEFINED AS FOLLOWS:1) 25% TO 50% REDUCTION IN THE CENTRAL CANAL AND/OR NERVE ROOT CANAL (SUBARTICULAR, NEUROFORAMINAL) COMPARED TO THE ADJACENT LEVELS ON RADIOGRAPHIC STUDIES, WITH RADIOGRAPHIC CONFIRMATION OF ANY ONE OF THE FOLLOWING:A) EVIDENCE OF THECAL SAC AND/OR CAUDA EQUINA COMPRESSION;B) EVIDENCE OF NERVE ROOT IMPINGEMENT (DISPLACEMENT OR COMPRESSION) BY EITHER OSSEOUS OR NON-OSSEOUS ELEMENTS; ANDC) EVIDENCE OF HYPERTROPHIC FACETS WITH CANAL ENCROACHMENT. 2) AND ASSOCIATED WITH THE FOLLOWING CLINICAL SIGNS:A) PRESENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION (PF) DEFINED AS A SCORE OF >= 2.0 OF THE ZURICH CLAUDICATION QUESTIONNAIRE (ZCQ); ANDB) ABILITY TO SIT FOR 50 MINUTES WITHOUT PAIN AND TO WALK 50 FEET OR MORE.
P140005||ORTHOGENRX,INC|7044 ELY ROAD||NEW HOPE|PA|18938||Acid, hyaluronic, intraarticular|GENVISC 850|MOZ|OR|||N|04/16/2014|09/02/2015|15M-3258|10/15/2015|APPR|APPROVAL FOR GENVISC 850®. THIS DEVICE IS INDICATED FOR OR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P140008||APOLLO ENDOSURGERY INC|1120 S CAPITAL OF TX HWY|BLDG 1, STE 300|AUSTIN|TX|78746|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|ORBERA INTRAGASTRIC BALLOON|LTI|GU|||N|04/29/2014|08/05/2015|15M-2964|08/06/2015|APPR|APPROVAL FOR THE ORBERA INTRAGASTRIC BALLOON. THE ORBERA INTRAGASTRIC BALLOON SYSTEM IS INDICATED FOR USE AS AN ADJUNCT TO WEIGHT REDUCTION FOR ADULTS WITH OBESITY WITH BODY MASS INDEX (BMI) OF >= 30 AND <= 40 KG/M2 AND IS TO BE USED IN CONJUNCTION WITH A LONG-TERM SUPERVISED DIET AND BEHAVIOR MODIFICATION PROGRAM DESIGNED TO INCREASE THE POSSIBILITY OF SIGNIFICANT LONG-TERM WEIGHT LOSS AND MAINTENANCE OF THAT WEIGHT LOSS. ORBERA IS INDICATED FOR ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS. THE MAXIMUM PLACEMENT PERIOD FOR ORBERA IS 6 MONTHS.
P140009||St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO NEUROSTIMULATION SYSTEM|MHY|NE|||N|05/05/2014|06/12/2015|15M-2497|07/10/2015|APPR|APPROVAL FOR THE BRIO NEUROSTIMULATION SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING CONDITIONS:1) BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY TO REDUCE SOME OF THE SYMPTOMS OF ADVANCED LEVODOPA-RESPONSIVE PARKINSONS DISEASE THAT ARE NOT ADEQUATELY CONTROLLED BY MEDICATIONS; AND 2) UNILATERAL OR BILATERAL STIMULATION OF THE VENTRAL INTERMEDIATE NUCLEUS (VIM) OF THE THALAMUS FOR THE SUPPRESSION OF DISABLING UPPER EXTREMITY TREMOR IN ADULT ESSENTIALTREMOR PATIENTS WHOSE TREMOR IS NOT ADEQUATELY CONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.
P140010||MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|||Y|05/29/2014|12/30/2014|15M-0199|01/20/2015|APPR|FOR THE IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THIS DEVICE IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AFTER PREDILATATION, OF DE NOVO OR RESTENOTIC LESIONS UP TO 180 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 4-7 MM.
P140011||SIEMENS MEDICAL SOLUTIONS USA, INC.|51 VALLEY STREAM PKWY.||MALVERN|PA|19355|1406|Digital breast tomosynthesis|MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION|OTE|RA|||N|06/26/2014|04/21/2015|15M-1460|05/18/2015|APPR|APPROVAL FOR THE MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION. THIS DEVICE IS INDICATED FOR THE ACQUISITION OF 2D AS WELL AS 3D DIGITAL MAMMOGRAPHY IMAGES TO BE USED IN SCREENING AND DIAGNOSIS OF BREAST CANCER. EACH SCREENING EXAMINATION MAY CONSIST OF CC AND MLO VIEWS IN: A 2D IMAGE SET, OR A 2D AND 3D IMAGE SET. NOTE: THE SCREENING EXAMINATION MAY CONSIST OF 2D FFDM IMAGES SET WITH OR WITHOUT THE 3D  IMAGE SET.
P140012||RESHAPE MEDICAL, INC.|100 CALLE IGLESIA||SAN CLEMENTE|CA|92672||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|RESHAPE INTEGRATED DUAL BALLOON SYSTEM|LTI|GU|||N|07/01/2014|07/28/2015|15M-2740|07/29/2015|APPR|APPROVAL FOR THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM. THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM IS INDICATED FOR WEIGHT REDUCTION WHEN USED IN CONJUNCTION WITH DIET AND EXERCISE, IN OBESE PATIENTS WITH A BODY MASS INDEX (BMI) OF 30 40 KG/M2 AND ONE OR MORE OBESITY-RELATED COMORBID CONDITIONS. IT IS INDICATED FOR USE IN ADULT PATIENTS WHO HAVE FAILED WEIGHT REDUCTION WITH DIET AND EXERCISE ALONE.
P140013||MINERVA SURGICAL|101 SAGINAW DRIVE||REDWOOD CITY|CA|94063||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MINERVA ENDOMETRIAL ABLATION SYSTEM|MNB|OB|||N|07/01/2014|07/27/2015|15M-2739|08/27/2015|APPR|APPROVAL FOR THE MINERVA ENDOMETRIAL ABLATION SYSTEM. THIS DEVICE IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
P140015||Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Pump, infusion, insulin, to be used with invasive glucose sensor|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|OYC|CH|||N|07/17/2014|09/08/2015|15M-3376|10/15/2015|APPR|APPROVAL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (¿T:SLIM G4 SYSTEM¿). THIS DEVICE CONSISTS OF THE T:SLIM G4 INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER.THE T:SLIM G4 INSULIN PUMP IS INTENDED FOR THE SUBCUTANEOUS DELIVERY OF INSULIN, AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN. THE T:SLIM G4 INSULIN PUMP CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY AND AS PART OF THE T:SLIM G4 SYSTEM TO RECEIVE AND DISPLAY CONTINUOUS GLUCOSE MEASUREMENTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER. THE T:SLIM G4 SYSTEM ALSO INCLUDES CONTINUOUS GLUCOSE MONITORING (CGM) INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS WITH DIABETES FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE T:SLIM G4 SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE T:SLIM G4 SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME. THE T:SLIM G4 SYSTEM IS INDICATED FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND GREATER. THE T:SLIM G4 SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.
P140016||COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT|MIH|CV|||N|08/13/2014|09/15/2015|15M-3377|10/15/2015|APPR|APPROVAL FOR THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ISOLATED LESIONS OF THE DESCENDING THORACIC AORTA (NOT INCLUDING DISSECTIONS) HAVING VASCULAR ANATOMY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:1) ILIAC/FEMORAL ANATOMY THAT IS SUITABLE FOR ACCESS WITH THE REQUIRED INTRODUCTION SYSTEMS; AND2) NONANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE THORACIC LESION:A) WITH A LENGTH OF AT LEAST 20 MM; ANDB) WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 42 MM AND NO LESS THAN 15 MM.
P140017||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MVS83|MOUNDS VIEW|MN|55112||Pulmonary valve prosthesis percutaneously delivered|MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)|NPV|CV|||Y|08/21/2014|01/27/2015|15M-0266|01/27/2015|APPR|APPROVAL THE MELODY TRANSCATHETER PULMONARY VALVE (TPV) AND THE ENSEMBLE TRANSCATHETER VALVE DELIVERYSYSTEM. THIS DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SURGERY IN THE MANAGEMENT OF PEDIATRIC AND ADULT PATIENTS WITH THE FOLLOWING CLINICAL CONDITIONS:1) EXISTENCE OF A FULL (CIRCUMFERENTIAL) RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) CONDUIT THAT WAS EQUAL TO OR GREATER THAN 16 MM IN DIAMETER WHEN ORIGINALLY IMPLANTED, AND 2) DYSFUNCTIONAL RVOT CONDUIT WITH A CLINICAL INDICATION FOR INTERVENTION, AND: A) REGURGITATION >= MODERATE REGURGITATION, AND/OR B) STENOSIS: MEAN RVOT GRADIENT >= MMHG.
P140018||MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||Agent, occluding, vascular, permanent|VENASEAL CLOSURE SYSTEM|PJQ|CV|||N|08/25/2014|02/20/2015|15M-0690|02/20/2015|APPR|APPROVAL FOR THE VENASEAL CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERMANENT CLOSURE OF LOWER EXTREMITY SUPERFICIAL TRUNCAL VEINS, SUCH AS THE GREAT SAPHENOUS VEIN (GSV), THROUGH ENDOVASCULAR EMBOLIZATION WITH COAPTATION.  VENASEAL IS INTENDED FOR USE IN ADULTS WITH CLINICALLY SYMPTOMATIC VENOUS REFLUX AS DIAGNOSED BY DUPLEX ULTRASOUND (DUS).
P140019||CERAPEDICS, LLC|11025 DOVER STREET|SUITE 1600|WESTMINSTER|CO|80021||Filler, bone void, synthetic peptide|I-FACTOR PEPTIDE ENHANCED BONE GRAFT|NOX|OR|||N|08/27/2014|11/03/2015|15M-4343|11/30/2015|APPR|APPROVAL FOR THE I-FACTOR PEPTIDE ENHANCED BONE GRAFT. THIS COMBINATION PRODUCT IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF A DEGENERATED CERVICAL DISC AT ONE LEVEL FROM C3-C4 TO C6-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT), WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVEL ABNORMALITY LOCALIZED TO THE DISC SPACE, AND CORRESPONDING TO AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT AS COMPARED TO ADJACENT LEVELS, AFTER FAILURE OF AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT. I-FACTOR PEPTIDE ENHANCED BONE GRAFT P-15 PUTTY MUST BE USED INSIDE AN ALLOGRAFT BONE RING AND WITH SUPPLEMENTAL ANTERIOR PLATE FIXATION.
P140020||MYRIAD GENETIC LABORATORIES|320 Wakara Way||Salt Lake City|UT|84108||Cancer-related germline gene mutation detection system|BRACANALYSIS CDX|PJG|PA|||Y|09/24/2014|12/19/2014|14M-2248|12/30/2014|APPR|APPROVAL FOR THE BRACANALYSIS CDX. THIS DEVICE IS INDICATED AS FOLLOWS:  BRACANALYSIS CDX IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION AND CLASSIFICATION OF VARIANTS IN THE PROTEIN CODING REGIONS AND INTRON/EXON BOUNDARIES OF THE BRCA1 AND BRCA2 GENES USING GENOMIC DNA OBTAINED FROM WHOLE BLOOD SPECIMENS COLLECTED IN EDTA. SINGLE NUCLEOTIDE VARIANTS AND SMALL INSERTIONS AND DELETIONS (INDELS) ARE IDENTIFIED BY POLYMERASE CHAIN REACTION (PCR) AND SANGER SEQUENCING. LARGE DELETIONS AND DUPLICATIONS IN BRCA1 AND BRCA2 ARE DETECTED USING MULTIPLEX PCR. RESULTS OF THE TEST ARE USED AS AN AID IN IDENTIFYING OVARIAN CANCER PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA VARIANTS ELIGIBLE FOR TREATMENT WITH LYNPARZA (OLAPARIB). THIS ASSAY IS FOR PROFESSIONAL USE ONLY AND IS TO BE PERFORMED ONLY AT MYRIAD GENETIC LABORATORIES, A SINGLE LABORATORY SITE LOCATED AT 320 WAKARA WAY, SALT LAKE CITY, UT 84108.
P140021||ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0416|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV|MZO|MI|||N|10/01/2014|06/11/2015|15M-2217|07/10/2015|APPR|APPROVAL FOR THE ELECSYS ANTI-HCV II IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HCV. THIS DEVICE IS INDICATED FOR: ELECSYS ANTI-HCV II IMMUNOASSAYIMMUNOASSAY FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN ADULT AND PEDIATRIC (AGES 18 MONTHS THROUGH 21 YEARS) SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN, AND SODIUM CITRATE). ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE PRESUMPTIVE DIAGNOSIS OF HCV INFECTION IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE.THE ELECTROLUMINESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER.ELECSYS PRECICONTROL ANTI-HCV ELECSYS PRECICONTROL ANTI-HCV IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HCV IMMUNOASSAY ON THE COBAS E 601 AND COBAS E 602 IMMUNOASSAY ANALYZERS AND THE ELECSYS ANTI-HCV II IMMUNOASSAY ON THE COBAS E 601 IMMUNOASSAY ANALYZER.
P140023||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS KRAS MUTATION TEST|OWD|PA|||N|10/23/2014|05/07/2015|15M-1708|05/18/2015|APPR|APPROVAL FOR THE COBAS KRAS MUTATION TEST. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE COBAS KRAS MUTATION TEST, FOR USE WITH THE COBAS 4800 SYSTEM, IS A REAL-TIME PCR TEST FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN CODONS 12 AND 13 OF THE KRAS GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED HUMAN COLORECTAL CANCER (CRC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED AS AN AID IN THE IDENTIFICATION OF CRC PATIENTS FOR WHOM TREATMENT WITH ERBITUX (CETUXIMAB) OR WITH VECTIBIX (PANITUMUMAB) MAY BE INDICATED BASED ON A NO MUTATION DETECTED RESULT.SPECIMENS ARE PROCESSED USING THE COBAS DNA SAMPLE PREPARATION KIT FOR MANUAL SAMPLE PREPARATION AND THE COBAS Z 480 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION.
P140025||VENTANA MEDICAL SYSTEMS, INC.|1910 EAST INNOVATION PARK DR.||TUCSON|AZ|85755||Immunohistochemistry assay, antibody, anaplastic lymphoma kinase|VENTANA ALK (D5F3) CDX ASSAY|PKW|PA|||N|11/14/2014|06/12/2015|15M-2219|07/10/2015|APPR|APPROVAL FOR THE VENTANA ALK (D5F3) CDX ASSAY. THIS DEVICE IS INDICATED FOR THE FOLLOWING:VENTANA ALK (D5F3) CDX ASSAY IS INTENDED FOR THE QUALITATIVE DETECTION OF THE ANAPLASTIC LYMPHOMA KINASE (ALK) PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SMALL CELL LUNG CARCINOMA (NSCLC) TISSUE STAINED WITH A BENCHMARK XT AUTOMATED STAINING INSTRUMENT. IT IS INDICATED AS AN AID IN IDENTIFYING PATIENTS ELIGIBLE FOR TREATMENT WITH XALKORI® (CRIZOTINIB).
P140026||SILK ROAD MEDICAL, INC|735 NORTH PASTORIA AVE||SUNNYVALE|CA|94085||STENT, CAROTID|ENROUTE TRANSCAROTID STENT SYSTEM|NIM|CV|||N|11/17/2014|05/18/2015|15M-1956|06/02/2015|APPR|APPROVAL FOR THE ENROUTE TRANSCAROTID STENT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) FOR THE TREATMENT OF PATIENTS AT HIGH RISKFOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW.1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM; 2) PATIENTS MUST HAVE A VESSEL DIAMETER OF 4-9MM AT THE TARGET LESION; AND 3) CAROTID BIFURCATION IS LOCATED AT MINIMUM 5 CM ABOVE THE CLAVICLE TO ALLOW FOR PLACEMENT OF THE ENROUTE TRANSCAROTID NPS.
P140028||BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|||N|12/10/2014|07/21/2015|15M-2618|08/28/2015|APPR|APPROVAL FOR THE INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR: THE INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY (PPA) WITH REFERENCE VESSEL DIAMETERS FROM 4.0 MM TO 7.0 MM AND LESION LENGTHS UP TO 190 MM.
P140030||BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||STENT, ILIAC|ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM|NIO|CV|||N|12/18/2014|12/17/2015|15M-4947|12/22/2015|APPR|APPROVAL FOR THE ASTRON PERIPHERAL SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETERIN PATIENTS WITH ILIAC ATHEROSCLEROTIC LESIONS IN VESSEL REFERENCE DIAMETERS BETWEEN 4.3MM AND9.5MM AND LESION LENGTHS UP TO 105MM.
P140031||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|||Y|12/22/2014|06/17/2015|15M-2499|07/16/2015|APPR|APPROVAL FOR THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, MODEL 9600TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE 8% OR AT A 15% RISK OF MORTALITY AT 30 DAYS).
P150001||MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Artificial pancreas device system, threshold suspend|MINIMED 630G SYSTEM WITH SMARTGUARD|OZO|CH|||N|01/08/2015|08/10/2016|16M-2500|09/06/2016|APPR|Approval for the MiniMed 630G System with SmartGuard.
P150003||BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|||N|01/15/2015|10/02/2015|15M-4014|11/02/2015|APPR|APPROVAL FOR THE SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE, STABLEANGINA, UNSTABLE ANGINA, NON-ST ELEVATION MI OR DOCUMENTED SILENT ISCHEMIA DUE TO ATHEROSCLEROTIC LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.0 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
P150004||Spinal Modulation, Inc|1135 O'BRIEN DR||MENLO PARK|CA|94025||Dorsal root ganglion stimulator for pain relief|Axium Neurostimulator System|PMP|NE|||N|01/29/2015|02/11/2016|16M-0804|03/07/2016|APPR|Approval for the Axium Spinal Modulation Neurostimulator System. This device is indicated for: spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II**. *	Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study. **	Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively.
P150005||Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OPEN-IRRIGATED ABLATION CATHETER|OAD|CV|||N|02/02/2015|02/24/2016|16M-0807|03/07/2016|APPR|Approval for the Blazer Open-Irrigated Ablation Catheter, when used with a Maestro 4000 Radiofrequency (RF) Controller and MetriQ Irrigation Pump, is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent Type I Atrial Flutter (AFL) in patients age 18 or older.
P150006||VASORUM LTD|2012 ORCHARD AVE|CITYWEST BUSINESS CAMPUS|DUBLIN||24||Device, hemostasis, vascular|CELT ACD VASCULAR CLOSURE DEVICE|MGB|CV|||N|02/03/2015|07/20/2016|16m-2185|07/25/2016|APPR|Approval for the  Celt ACD Vascular Closure Device.  This device is indicated for the percutaneous closure of common femoral artery puncture sites while reducing time-to-hemostasis in patients who have undergone diagnostic or interventional intra-arterial catheterization procedures where either 5F or 6F introducer sheaths have been used.
P150010||FIDIA FARMACEUTICI|PONTE DELLA FABBRICA 3/A||ABANO TERME||35031||Acid, hyaluronic, intraarticular|HYMOVIS|MOZ|OR|||N|02/25/2015|08/28/2015|15M-3256|10/14/2015|APPR|APPROVAL FOR HYMOVIS. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
P150011||LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|PERCEVAL SUTURELESS HEART VALVE|LWR|CV|||N|03/02/2015|01/08/2016|16M-0123|01/11/2016|APPR|Approval for the Perceval Sutureless Heart Valve. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
P150012||BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD|LWP|CV|||N|03/03/2015|04/25/2016|16M-1222|05/11/2016|APPR|Approval for The ImageReady MR Conditional Pacing System.  The device is indicated for the treatment of the following conditions:1) Symptomatic paroxysmal or permanent second- or third-degree AV block;2) Symptomatic bilateral bundle branch block;3) Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block);4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and5) Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes.Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity.Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony.Dual chamber modes are specifically indicated for treatment of the following:1) Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block;2) VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm; and3) Low cardiac output or congestive heart failure secondary to bradycardia. Passive-fixation Non-MRI Models 7631, 7632, 7635 and 7636 and MRI Models 7731, 7732, 7735 and 7736 are indicated for chronic pacing and sensing in the right atrium (Preformed Atrial J) or right ventricle (Straight) when used with a compatible pulse generator.Active-fixation Non-MRI Models 7640, 7641, and 7642 and MRI Models 7740, 7741, and 7742 are indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.The intended use of the slit suture sleeve accessory is to secure and immobilize Boston Scientific Ingevity leads at the venous entry site.The delivery stylet accessory is indicated for use with Boston Scientific implantable transvenous leads.
P150013||DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC 22C3 PHARMDX|PLS|PA|||Y|04/06/2015|10/02/2015|15M-3520|11/02/2015|APPR|APPROVAL FOR THE PD-L1 IHC 22C3 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING:  PD-L1 IHC 22C3 PHARMDX IS A QUALITATIVE IMMUNOHISTOCHEMICAL ASSAY USING MONOCLONAL MOUSE ANTI-PD-L1, CLONE 22C3 ANTIBODY INTENDED FOR USE IN THE DETECTION OF PD-L1PROTEIN IN FORMALIN FIXED, PARAFFIN EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48. PD-L1 PROTEIN EXPRESSION IS DETERMINED BY USING TUMOR PROPORTION SCORE (TPS), WHICH IS THE PERCENTAGE OF VIABLE TUMOR CELLS SHOWING PARTIAL OR COMPLETE MEMBRANE STAINING. THE SPECIMEN SHOULD BE CONSIDERED PD-L1 POSITIVE IF TPS >= 50% OF THE VIABLE TUMOR CELLS EXHIBIT MEMBRANE STAINING AT ANY INTENSITY. PD-L1 IHC 22C3 PHARMDX IS INDICATED AS AN AID IN IDENTIFYING NSCLC PATIENTS FOR TREATMENT WITH KEYTRUDA (PEMBROLIZUMAB).
P150014||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS HBV TEST|MKT|MI|||N|04/24/2015|10/14/2015|15M-4069|11/05/2015|APPR|APPROVAL FOR THE COBAS HBV. THIS DEVICE IS INDICATED FOR:  COBAS HBV IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN EDTA PLASMA OR SERUM OF HBV-INFECTED INDIVIDUALS. THIS TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY. THE TEST CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM COBAS HBV MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.THE COBAS HBV IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HBV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV INFECTION.
P150015||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS HCV TEST|MZP|MI|||N|04/27/2015|10/14/2015|15M-4018|11/03/2015|APPR|APPROVAL FOR THE COBAS HCV. THIS DEVICE IS INDICATED FOR:  COBAS HCV IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR BOTH THE DETECTION AND QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA, IN HUMAN EDTA PLASMA OR SERUM, OF HCV ANTIBODY POSITIVE OR HCV-INFECTED INDIVIDUALS. SPECIMENS CONTAINING HCV GENOTYPES 1 TO 6 ARE VALIDATED FOR DETECTION AND QUANTITATION IN THE ASSAY.  COBAS HCV IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF HCV INFECTION IN THE FOLLOWING POPULATIONS: INDIVIDUALS WITH ANTIBODY EVIDENCE OF HCV WITH EVIDENCE OF LIVER DISEASE, INDIVIDUALS SUSPECTED TO BE ACTIVELY INFECTED WITH HCV ANTIBODY EVIDENCE, AND INDIVIDUALS AT RISK FOR HCV INFECTION WITH ANTIBODIES TO HCV. DETECTION OF HCV RNA INDICATES THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE INFECTION.COBAS HCV IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY CAN BE USED TO MEASURE HCV RNA LEVELS AT BASELINE, DURING TREATMENT, AT THE END OF TREATMENT, AND AT THE END OF FOLLOW UP OF TREATMENT TO DETERMINE SUSTAINED OR NON-SUSTAINED VIRAL RESPONSE. THE RESULTS MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.COBAS HCV HAS NOT BEEN APPROVED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HCV IN BLOOD OR BLOOD PRODUCTS.  ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH CERTAIN DIRECT-ACTING ANTIVIRAL AGENTS (DAA) REGIMENS. NO INFORMATION IS AVAILABLE ON THE ASSAYS PREDICTIVE VALUE WHEN OTHER DAA COMBINATION THERAPIES ARE USED.
P150016||NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|TRIDYNE VASCULAR SEALANT|NBE|CV|||N|04/27/2015|04/11/2016|16M-1166|05/11/2016|APPR|The Tridyne Vascular Sealant is indicated for use in aortic surgery when adjunctive measures to achieve hemostasis are required by mechanically sealing areas of leakage.
P150017||Cartiva, Inc|6120 Windward Parkway|Suite 220|Alpharetta|GA|30005||Prosthesis, metatarsophalangeal joint cartilage replacement implant|CARTIVA SYNTHETIC CARTILAGE IMPLANT|PNW|OR|||N|05/01/2015|07/01/2016|16M-1916|07/08/2016|APPR|Approval for use in the treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus.
P150019||MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|||N|06/10/2015|12/07/2015|15M-4728|12/22/2015|APPR|APPROVAL FOR THE PARADIGM REAL-TIME REVEL SYSTEM. THIS DEVICE IS INDICATED FOR:PARADIGM REAL-TIME REVEL INSULIN PUMP.  THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-523/MMT-723) ARE INDICATED FOR THE CONTINUOUS DELIVERY OF INSULIN, AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN.  THE PARADIGM REAL-TIME REVEL SYSTEM CONSISTS OF THE PARADIGM MMT-523/MMT-723 INSULIN PUMPS, THE ENLITE GLUCOSE SENSOR (MMT-7008), AND THE MINILINK TRANSMITTER (MMT-7703). USE OF THE PARADIGM MMT-523/MMT-723 INSULIN PUMPS WITH THE OPTIONAL SENSOR AND TRANSMITTER COMPONENTS IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, AND POSSIBLE LOW AND HIGH BLOOD GLUCOSE EPISODES IN ADULTS (AGES 18 AND OLDER).  ENLITE SENSOR:  THE ENLITE SENSOR (MMT-7008) IS INTENDED FOR USE WITH THE PARADIGM REAL-TIME REVEL INSULIN PUMP SYSTEMS (MMT-523/MMT-723) TO CONTINUOUSLY MONITOR GLUCOSE LEVELS IN PERSONS WITH DIABETES.GLUCOSE VALUES PROVIDED BY THE PARADIGM REAL-TIME REVEL SYSTEM ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON THE SENSOR GLUCOSE READINGS PROVIDED BY THE PARADIGM REAL-TIME REVEL SYSTEM.
P150021||Abbott Diabetes Care Inc.|1360 SOUTH LOOP RD.||ALAMEDA|CA|94502||Sensor, glucose, invasive|FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM|MDS|CH|||N|06/19/2015|09/23/2016|16M-2971|09/26/2016|APPR|The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The System is intended for use by health care professionals and requires a prescription. Readings from the FreeStyle Libre Pro Sensor are only made available to patients through consultation with a health care professional. The System does not require user calibration with blood glucose values.The FreeStyle Libre Pro System aids in the detection of glucose level excursions above or below the desired range, facilitating therapy adjustments. Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should be based on the trends and patterns analyzed through time using the reports available.
P150022||REX MEDICAL, L.P.|555 E. NORTH LANE SUITE 5035||CONSHOHOCKEN|PA|19428||Device, hemostasis, vascular|CLOSER VASCULAR SEALING SYSTEM|MGB|CV|||N|06/25/2015|02/12/2016|16M-0805|03/03/2016|APPR|Approval for the Closer Vascular Sealing System (VSS). This device is indicated for the percutaneous closure of femoral artery access sites while reducing times to hemostasis and ambulation as compared to Performance Goals in patients who have undergone diagnostic or interventional endovascular procedures utilizing 5, 6 and 7 Fr procedural sheaths.
P150023||ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||Absorbable coronary drug-eluting stent|ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM|PNY|CV|||N|07/01/2015|07/05/2016|16M-1914|07/21/2016|APPR|Approval for the ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) System.  This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions >=2.5 mm to <=3.75 mm in diameter in lesions <=24 mm in length.
P150024||ASPIRE BARIATRICS INC|3200 HORIZON DRIVE|SUITE 100|King of Prussia|PA|19406||Aspiration therapy system|AspireAssist|OYF|GU|||N|07/08/2015|06/14/2016|16m-1754|06/14/2016|APPR|Approval for the AspireAssist® is intended to assist in weight reduction of obese patients. It is indicated for use in adults aged 22 or older with a Body Mass Index (BMI) of 35.0-55.0 kg/m2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy. The AspireAssist is intended for a long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.
P150025||DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC NIVOLUMAB PHARMDX|PLS|PA|||N|07/09/2015|10/09/2015|15M-4016|11/02/2015|APPR|APPROVAL FOR THE PD-L1 IHC 28-8 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING:1) PD-L1 IHC 28-8 PHARMDX IS A QUALITATIVE IMMUNOHISTO-CHEMICAL ASSAY USING MONOCLONAL RABBIT ANTI-PD-L1, CLONE 28-8 INTENDED FOR USE IN THE DETECTION OF PD-L1 PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48; 2) PD-L1 PROTEIN EXPRESSION IS DEFINED AS THE PERCENTAGE OF TUMOR CELLS EXHIBITING POSITIVE MEMBRANE STAINING AT ANY INTENSITY; AND3) PD-L1 EXPRESSION AS DETECTED BY PD-L1 IHC 28-8 PHARMDX IN NON-SQUAMOUS NSCLC MAY BE ASSOCIATED WITH ENHANCED SURVIVAL FROM OPDIVO  (NIVOLUMAB).
P150026||CARDIOFOCUS, INC.|500 NICKERSON ROAD||MARLBOROUGH|MA|01752||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM|OAE|CV|||N|07/30/2015|04/01/2016|16M-1124|04/12/2016|APPR|The HeartLight® Endoscopic Ablation System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation
P150027||DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC NIVOLUMAB PHARMDX|PLS|PA|||N|08/04/2015|01/23/2016|16M-0803|03/03/2016|APPR|APPROVAL FOR THE PD-L1 IHC 28-8 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING:PD-L1 IHC 28-8 PHARMDX IS A QUALITATIVE IMMUNOHISTOCHEMICAL ASSAY USING MONOCLONAL RABBIT ANTI-PD-L1, CLONE 28-8 INTENDED FOR USE IN THE DETECTION OF PD-L1 PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SQUAMOUS NON SMALL CELL LUNG CANCER (NSCLC) AND MELANOMA TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48. PD-L1 PROTEIN EXPRESSION IS DEFINED AS THE PERCENTAGE OF TUMOR CELLS EXHIBITING POSITIVE MEMBRANE STAINING AT ANY INTENSITY.  PD-L1 EXPRESSION AS DETECTED BY PD-L1 IHC PHARMDX IN NONSQUAMOUS NSCLC MAY BE ASSOCIATED WITH ENHANCED SURVIVAL FROM OPDIVO® (NIVOLUMAB).POSITIVE PD-L1 STATUS AS DETERMINED BY PD-L1 IHC 28-8 PHARMDX IN MELANOMA IS CORRELATED WITH THE MAGNITUDE OF THE TREATMENT EFFECT ON PROGRESSION-FREE SURVIVAL FROM OPDIVO®.
P150028||NUMED, INC.|2880 MAIN ST.||HOPKINTON|NY|12965||Aortic stent|CHEATHAM PLATINUM STENT SYSTEM|PNF|CV|||Y|08/05/2015|03/25/2016|16M-1122|04/12/2016|APPR|Approval for the Cheatham Platinum (CP) Stent System, including the CP Stent, Mounted CP Stent, Covered CP Stent, and Covered Mounted CP Stent.  The CP Stent and Mounted CP Stent are indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving a compliant aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery and balloon angioplasty is contraindicated or predicted to be ineffective.The Covered CP Stent and Covered Mounted CP Stent are indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving the aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery associated with one or more of the following: Acute or chronic aortic wall injury; Nearly atretic descending aorta of 3 mm or less in diameter; A non-compliant stenotic aortic segment found on pre-stent balloon dilation; A genetic or congenital syndrome associated with aortic wall weakening or ascending aortic aneurysm.
P150029||MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|IPRO2 CGM SYSTEM WITH ENLITE SENSOR|MDS|CH|||N|08/10/2015|06/17/2016|16m-1755|06/24/2016|APPR|Approval for the iPro2 System. This device is indicated for:The iPro2 Recorder is to be used with either Enlite sensor or Sof-Sensor and is intended to continuously record interstitial glucose levels in persons with diabetes mellitus.  This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring device.  The information collected by the iPro2 Recorder may be uploaded to a computer (with Internet access) and reviewed by healthcare professionals.  This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.The iPro2 system:1)	Is intended for prescription use only;2)	Does not allow data to be made available directly to patients in real time;3)	Provides data that will be available for review by physicians after the recording interval (up to 144 hours);4)	Is intended for occasional rather than everyday use; and5)	Is to be used only as a supplement, and not a replacement for, standard invasive measurement.
P150030||Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|R3 DELTA CERAMIC HIP SYSTEM|MRA|OR|||N|08/20/2015|10/17/2016|16M-3430|10/20/2016|APPR|Approval for the R3TM delta Ceramic Acetabular System.  This device is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
P150033||MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM|PNJ|CV|||Y|09/17/2015|04/06/2016|16M-1125|04/12/2016|APPR|Approval for the Micra Transcatheter Pacemaker System (Pacemaker Model MC1VR01 and Programmer Application Software model SW022 Version 1.1).  This device is indicated for use in patients who have experienced one or more of the following conditions:• symptomatic paroxysmal or permanent high-grade AV block in the presence of AF• symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy• symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapyRate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity.
P150034||REVISION OPTICS, INCORPORATED|25651 Atlantic Ocean Dr Ste A1||Lake Forest|CA|92630||Implant, corneal, refractive|Raindrop Near Vision Inlay|LQE|OP|||N|09/24/2015|06/29/2016|16M-1837|07/08/2016|APPR|Approval for the Raindrop® Near Vision Inlay. This device is indicated for intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age, who have manifest refractive spherical equivalent of (MRSE) +1.00 diopters (D) to -0.50 D with less than or equal to 0.75 D of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1.50 D to +2.50 D of reading add.
P150036||EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||heart-valve, non-allograft tissue|EDWARDS INTUITY ELITE VALVE SYSTEM|LWR|CV|||N|10/13/2015|08/12/2016|16M-2485|08/15/2016|APPR|Approval for the EDWARDS INTUITY Elite Valve System.  This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
P150037||Alcon Research, Ltd|6201 South Freeway||Fort Worth|TX|76134||Intraocular pressure lowering implant|CyPass Micro-Stent|OGO|OP|||N|10/21/2015|07/29/2016|16M-2333|08/18/2016|APPR|Approval for the CyPass® System, Model 241-S.  This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).
P150038||InSightec|5 NAHUM HETH STREET||TIRAT-HACARMET||39120||MR-Guided Focused Ultrasound System|EXABLATE|POH|NE|||N|10/21/2015|07/11/2016|16M-2183|07/25/2016|APPR|Approval for the ExAblate Model 4000 Type 1.0 System (ExAblate Neuro).  This device is indicated for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the ExAblate device.
P150040||Carl Zeiss Meditec, Inc.|5160 Hacienda Drive||Dublin|CA|94568||Femtosecond laser system for refractive correction|VISUMAX FEMTOSECOND LASER|OTL|OP|||N|10/30/2015|09/13/2016|16M-2735|09/16/2016|APPR|Approval for the VisuMax Femtosecond Laser.  This device is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >= -1.00 D to <= -8.00 D, with <= -0.50 D cylinder and MRSE <= -8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <= 0.50 D MRSE.
P150041||ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, chromosome 17p deletion (TP53)|VYSIS CLL FISH PROBE KIT|PNK|PA|||N|10/30/2015|04/11/2016|16M-1167|05/11/2016|APPR|The Vysis CLL FISH Probe Kit is a test to detect deletion of the LSI TP53 probe target via fluorescence in situ hybridization (FISH) in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).The test is indicated for detecting deletion of the LSI TP53 probe target (17p-) as an aid in identifying those patients with CLL for whom treatment with VENCLEXTA® (venetoclax) is indicated. Vysis CLL FISH Probe Kit is not intended for monitoring of residual disease.
P150043||QView Medical, Inc.|4546 EL CAMINO REAL|SUITE 215|LOS ALTOS|CA|94022||Analyzer,medical image|QVCAD SYSTEM|MYN|RA|||N|11/23/2015|11/09/2016|16M-3914|11/16/2016|APPR|Approval for the QVCAD System.  The QVCAD System is indicated for use as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System (screening mammography BI- RADS® Assessment Category 1 or 2, and BI-RADS Composition/Density c or d) to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators produced by the QVCAD System are not  intended  to  be  used  for  diagnostic  characterization  of  suspicious findings.
P150044||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|cobas EGFR MUTATION TEST v2|OWD|PA|||Y|11/23/2015|09/28/2016|16M-2973|10/10/2016|APPR|The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients.  Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug                     FFPET	                           PlasmaTARCEVA® (erlotinib)	 Exon 19 deletions and L858R	Exon 19 deletions and L858RTAGRISSO  (osimertinib) 790M        T790M*Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.  *The efficacy of TAGRISSO (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas® EGFR Mutation Test v2:  Table 2Drug	               FFPET                                             PlasmaTARCEVA® (erlotinib) G719X, exon 20 insertions, T790M, S768I and L861Q   G719X, exon 20 insertions, T790M, S768I and L861QTAGRISSO (osimertinib)	G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q     G719X, exon 19 deletions, L858R, exon 20 insertions,  S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.
P150047||Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|cobas EGFR MUTATION TEST v2|OWD|PA|||Y|12/09/2015|06/01/2016|16M-1459|06/06/2016|APPR|Approval for the cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients.  Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling.Table 1 Drug	FFPET	PlasmaTARCEVA® (erlotinib)	Exon 19 deletions and L858R	Exon 19 deletions and L858RTAGRISSO (osimertinib)	T790M		Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA® (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas® EGFR Mutation Test v2.  Table 2 Drug	FFPET	PlasmaTARCEVA® (erlotinib)	G719X, exon 20 insertions, T790M, S768I and L861Q	G719X, exon 20 insertions, T790M, S768I and L861QTAGRISSO (osimertinib)	G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q	G719X, exon 19 deletions, L858R, exon 20 insertions, T790M, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.
P160001||OBALON THERAPEUTICS, INC.|5421 AVENIDA ENCINAS|SUITE F|CARLSBAD|CA|92008||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|OBALON BALLOON SYSTEM|LTI|GU|||N|01/07/2016|09/08/2016|16M-2651|09/14/2016|APPR|Approval for the Obalon Balloon System.  The device is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 to 40 kg/m2) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program.  All balloons must be removed 6 months after the first balloon is placed.
P160002||VENTANA MEDICAL SYSTEMS, INC.|1910 EAST INNOVATION PARK DR.||TUCSON|AZ|85755||Immunohistochemistry assay, antibody, programmed death-ligand 1|VENTANA PD-L1(SP142) CDX ASSAY|PLS|PA|||N|01/13/2016|05/18/2016|16M-1400|06/03/2016|APPR|Approval for the PD-L1(SP142) Assay. The device is indicated for the following:  VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplifcation Kit on a VENTANA BenchMark ULTRA instrument. PD-L1 status is determined by the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity.  PD-L1 expression in >= 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) in a non-randomized study of TECENTRIQ (atezolizumab).
P160004||W. L. GORE & ASSOCIATES, INC.|3250 WEST KILTIE LANE||FLAGSTAFF|AZ|86005||STENT, SUPERFICIAL FEMORAL ARTERY|GORE TIGRIS VASCULAR STENT|NIP|CV|||N|02/01/2016|07/27/2016|16M-2332|08/05/2016|APPR|Approval for the GORE TIGRIS Vascular Stent.  This device is intended to improve luminal diameter in patients with symptomatic de-novo or restenotic lesions or occlusions in the native superficial femoral artery (SFA) and proximal popliteal artery (PPA) with reference vessel diameters ranging from 4.0-6.5 mm and lesion lengths up to 240 mm.
N10389|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|11/19/1980|01/06/1981|||APPR|
N10389|S010|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|10/21/1980|01/06/1981|||APPR|
N10389|S011|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/1980|07/07/1981|||APPR|
N10389|S012|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE (PALIN!CHROMIC) ABSORBABLE|GAL|SU|||N|01/30/1981|04/24/1981|||APPR|
N10389|S013|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|05/19/1981|08/11/1981|||APPR|
N10389|S014|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|05/19/1981|07/28/1981|||APPR|
N10389|S015|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|03/04/1982|07/21/1982|||APPR|
N10389|S016|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|07/23/1982|12/22/1982|||APPR|
N10389|S017|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|12/08/1982|07/05/1983|||APPR|
N10389|S018|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|02/24/1983|04/04/1983|||APPR|
N10389|S019|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|04/27/1983|06/03/1983|||APPR|
N10389|S020|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|05/09/1983|11/17/1983|||APPR|
N10389|S021|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|09/09/1983|11/17/1983|||APPR|
N10389|S022|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|01/26/1984|04/04/1984|||APPR|
N10389|S023|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|10/21/1985|06/20/1986|||APPR|
N10389|S024|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N10389|S025|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/1987|08/28/1987|||APPR|
N10389|S026|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/02/1987|10/05/1987|||APPR|
N11397|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|10/10/1980|03/03/1981|||APPR|
N11397|S013|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|10/21/1980|01/06/1981|||APPR|
N11397|S014|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE|GAP|SU|||N|12/04/1980|07/07/1981|||APPR|
N11397|S015|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|05/19/1981|08/11/1981|||APPR|
N11397|S017|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|03/04/1982|07/21/1982|||APPR|
N11397|S018|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|05/13/1982|07/09/1982|||APPR|
N11397|S019|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|10/18/1982|12/02/1982|||APPR|
N11397|S020|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|10/20/1982|12/08/1982|||APPR|
N11397|S021|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|11/02/1982|03/15/1983|||APPR|
N11397|S022|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|02/16/1983|06/07/1983|||APPR|
N11397|S023|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|06/20/1983|09/28/1983|||APPR|
N11397|S024|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|||N|10/21/1985|06/20/1986|||APPR|
N11397|S025|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N11397|S026|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/1987|08/28/1987|||APPR|
N11397|S027|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1988|12/28/1988|||APPR|
N11397|S028|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/1990|03/20/1990|||APPR|
N12159|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|||N|06/27/1979|04/14/1980|||APPR|
N12159|S002|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|||N|11/18/1980|02/02/1981|||APPR|
N12159|S003|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|||N|08/11/1981|09/15/1982|||APPR|
N12159|S005|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|||N|03/29/1982|06/15/1982|||APPR|
N12159|S006|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|||N|03/13/1986|03/31/1986|||APPR|
N12159|S007|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/1987|08/05/1987|||APPR|
N12159|S008|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1987|04/21/1988|||APPR|
N12159|S010|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/1989|05/22/1989|||APPR|
N12159|S011|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL|LMG|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/16/1989|08/23/1989|||APPR|
N12159|S012|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/1993|10/13/1993|||APPR|
N12159|S013|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/1993|01/16/1996|||APPR|APPROVAL 1)PROCESS CHANGE THAT DELETES THE USE OF THE IN-PROCESS SOLVENT FREON AND REPLACES IT WITH PERFLUOROHEXANE 2) CHANGE OF IN-PROCESS MANUFACTURING FACILITY TO NORAMCO, INC., 1440 OLYMPIC DR., P.O. BOX 800001, ATHENS, GA 30608-8001 3)CHANGE OF QUALITY ASSURANCE SITE TO, JOHNSON AND JOHNSON MEDICAL, INC., U.S. HIGHWAY 75S AND 1417W, SHERMAN, TX 75091-9100 4)ADDITION OF ALTERNATE STERILIZATION SITE, JOHNSON & JOHNSON MEDICAL, INC., U.S. HIGHWAY 75S AND 1417W, SHERMAN, TX 75091-9100
N12815|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE POLYESTER SUTURE|GAO|SU|||N|10/09/1980|01/06/1981|||APPR|
N12815|S002|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|12/04/1980|07/07/1981|||APPR|
N12815|S011|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|10/21/1980|01/06/1981|||APPR|
N12815|S012|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|05/19/1981|08/11/1981|||APPR|
N12815|S013|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|02/11/1982|11/15/1982|||APPR|
N12815|S014|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|03/04/1982|07/21/1982|||APPR|
N12815|S015|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|02/16/1983|06/07/1983|||APPR|
N12815|S016|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|04/20/1983|07/05/1983|||APPR|
N12815|S017|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|06/07/1983|11/03/1983|||APPR|
N12815|S018|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|Normal 180 Day Track||N|06/20/1983|09/28/1983|||APPR|
N12815|S019|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|02/01/1984|03/29/1984|||APPR|
N12815|S020|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|||N|10/21/1985|06/20/1986|||APPR|
N12815|S021|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N12815|S022|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/1987|08/28/1987|||APPR|
N12815|S023|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Suture, nonabsorbable|MERSILENE*POLYESTER SUTURE|GAO|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1988|12/22/1988|||APPR|
N14226|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|11/19/1980|01/06/1981|||APPR|
N14226|S002|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|COLLAHEN SUTURE (PLAIN & CHROMIC) ABSORBABLE SURGI|GAL|SU|||N|12/04/1980|07/07/1981|||APPR|
N14226|S003|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|05/19/1981|08/11/1981|||APPR|
N14226|S004|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|06/05/1981|08/17/1981|||APPR|
N14226|S005|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|03/04/1982|07/21/1982|||APPR|
N14226|S006|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|10/21/1985|06/20/1986|||APPR|
N14226|S007|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N14226|S008|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/1987|08/28/1987|||APPR|
N15405|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|COLLAGEN SUTURE (PLAIN!CHROMIC) ABSORBABLE|GAL|SU|||N|12/04/1980|01/06/1981|||APPR|
N15405|S002|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|12/04/1980|07/07/1981|||APPR|
N15405|S003|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|ABSORBABLE SURGICAL SUTURE, USP|GAL|SU|||N|02/09/1981|04/24/1981|||APPR|
N15405|S004|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|COLLAGEN SUTURE (PLAIN!CHROMIC) ABSORBABLE|GAL|SU|||N|05/19/1981|08/11/1981|||APPR|
N15405|S005|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|COLLAGEN SUTURE (PLAIN!CHROMIC) ABSORBABLE|GAL|SU|||N|03/04/1982|07/21/1982|||APPR|
N15405|S006|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|COLLAGEN SUTURE (PLAIN!CHROMIC) ABSORBABLE|GAL|SU|||N|10/21/1985|06/20/1986|||APPR|
N15405|S007|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|COLLAGEN SUTURE (PLAIN CHROMIC) ABSORBABLE|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N16374|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|09/25/1980|12/31/1980|||APPR|
N16374|S002|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|10/20/1980|01/14/1981|||APPR|
N16374|S021|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|12/01/1980|01/06/1981|||APPR|
N16374|S022|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE POLYPROPYLENE NONAB.SURG. SUTURE|GAT|SU|||N|02/11/1981|06/11/1981|||APPR|
N16374|S023|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|05/19/1981|08/11/1981|||APPR|
N16374|S024|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|03/04/1982|07/21/1982|||APPR|
N16374|S025|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|12/20/1982|05/02/1984|||APPR|
N16374|S026|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|03/04/1983|04/07/1983|||APPR|
N16374|S027|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|12/09/1983|03/12/1984|||APPR|
N16374|S028|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|03/05/1984|06/10/1985|||APPR|
N16374|S029|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|11/29/1985|01/23/1986|||APPR|
N16374|S030|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|||N|03/21/1986|05/23/1986|||APPR|
N16374|S031|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N16374|S032|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N16374|S033|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/1987|08/28/1987|||APPR|
N16374|S034|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S|GAT|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/1988|10/07/1988|||APPR|
N16420|S001|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION|MENTOR POLYTEF PASTE FOR INJECTION|LTG|EN|Normal 180 Day Track||N|05/23/1983|12/20/1983|||APPR|
N16420|S004|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION|POLYTEF PASTE FOR VOCAL CORD INJECTION|LTG|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/1992|12/08/1993|||APPR|
N16837|S001|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|SURGIKOS ARTIGRAFT|LXA|CV|||N|06/29/1979|08/01/1979|||APPR|
N16881|S001|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON|GAM|SU|||N|10/22/1980|01/06/1981|||APPR|
N16881|S002|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON POLYGLYCOLIC ACID ABSORBABLE SURGICAL SUTURE|GAM|SU|||N|11/17/1980|07/20/1981|||APPR|
N16881|S003|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON POLYGLYCOLIC ACID SUTURES, SYNTHETIC|GAM|SU|||N|08/29/1980|03/03/1982|||APPR|
N16881|S004|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON|GAM|SU|||N|05/19/1981|07/15/1981|||APPR|
N16881|S005|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON|GAM|SU|||N|06/04/1981|09/01/1981|||APPR|
N16881|S006|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON|GAM|SU|||N|07/01/1981|12/04/1981|||APPR|
N16881|S008|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON|GAM|SU|||N|03/25/1986|07/07/1986|||APPR|
N16881|S009|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON|GAM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|05/19/1987|||APPR|
N16881|S010|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON|GAM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1987|06/05/1987|||APPR|
N16881|S011|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|DEXON|GAM|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/14/1987|11/30/1987|||APPR|
N16895|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track||N|03/02/1979|03/12/1979|||APPR|
N16895|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|12/11/1978|03/14/1979|||APPR|
N16895|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|02/15/1979|01/14/1980|||APPR|
N16895|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|06/06/1979|03/06/1980|||APPR|
N16895|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|07/13/1979|08/21/1979|||APPR|
N16895|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|08/02/1979|05/27/1980|||APPR|
N16895|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|02/05/1980|03/18/1980|||APPR|
N16895|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|04/21/1980|08/07/1980|||APPR|
N16895|S009|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|05/05/1980|09/17/1980|||APPR|
N16895|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|08/01/1980|02/17/1981|||APPR|
N16895|S011|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|08/15/1980|01/27/1981|||APPR|
N16895|S012|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B&L STERILE SALINE SOLUTION UNIT DOSE|LPM|OP|||N|08/25/1980|12/04/1981|||APPR|
N16895|S013|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|08/25/1980|02/02/1981|||APPR|
N16895|S014|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|09/26/1980|03/12/1981|||APPR|
N16895|S015|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|DISINFECTING UNIT III|LPM|OP|||N|12/30/1980|12/04/1981|||APPR|
N16895|S017|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|05/05/1981|09/23/1981|||APPR|
N16895|S018|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|07/29/1981|12/04/1981|||APPR|
N16895|S019|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS(R)  (POLYMACON) P.A.1 SERIES|LPM|OP|||N|10/19/1981|11/16/1982||12/17/1982|APPR|
N16895|S020|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|12/17/1981|03/03/1982|||APPR|
N16895|S021|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|02/19/1982|04/26/1982|||APPR|
N16895|S023|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|05/20/1982|08/23/1982|||APPR|
N16895|S024|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|07/20/1982|07/05/1983|||APPR|
N16895|S025|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|03/04(TM) LENS SERIES|LPM|OP|||N|08/25/1982|07/25/1983||08/16/1983|APPR|
N16895|S026|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|12/16/1982|02/10/1983|||APPR|
N16895|S027|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|12/27/1982|03/15/1983|||APPR|
N16895|S028|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|04/13/1983|12/05/1983|||APPR|
N16895|S029|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|11/14/1983|02/21/1986|||APPR|
N16895|S031|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|05/08/1984|05/02/1985|||APPR|
N16895|S033|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|06/22/1984|06/19/1985|||APPR|
N16895|S036|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|07/23/1984|08/14/1985|||APPR|
N16895|S037|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|02/07/1985|04/30/1986|||APPR|
N16895|S038|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|03/20/1985|05/02/1985|||APPR|
N16895|S040|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|08/30/1985|02/24/1986|||APPR|
N16895|S041|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|03/18/1986|07/31/1986|||APPR|
N16895|S042|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track||N|03/18/1986|05/30/1986|||APPR|
N16895|S043|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|||N|04/22/1986|07/23/1986|||APPR|
N16895|S044|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/20/1986|01/12/1987|||APPR|
N16895|S045|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Other Report|N|01/05/1987|08/31/1988|||APPR|
N16895|S046|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1987|09/21/1987|||APPR|
N16895|S047|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1987|05/05/1987|||APPR|
N16895|S048|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Other Report|N|05/15/1987|02/23/1988|||APPR|
N16895|S049|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|08/06/1987|09/21/1987|||APPR|
N16895|S050|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/02/1987|08/22/1988|||APPR|
N16895|S051|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/15/1987|05/02/1988|||APPR|
N16895|S052|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/1988|11/28/1988|||APPR|
N16895|S053|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/1988|02/09/1989|||APPR|
N16895|S054|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/20/1988|12/23/1988|||APPR|
N16895|S055|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/06/1988|04/20/1989|||APPR|
N16895|S056|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/1988|08/17/1989|||APPR|
N16895|S057|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1988|08/17/1989|||APPR|
N16895|S058|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1988|06/23/1989|||APPR|
N16895|S059|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/1989|04/12/1989|||APPR|
N16895|S060|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/25/1989|11/16/1989|||APPR|
N16895|S061|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/1989|12/28/1989|||APPR|
N16895|S062|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1989|09/21/1990|||APPR|
N16895|S063|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|12/28/1989|||APPR|
N16895|S064|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/1989|01/22/1990|||APPR|
N16895|S066|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/1989|12/28/1989|||APPR|
N16895|S067|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|1ROFESSIONAL ASEPTOR DISINFECTING UNIT|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/1990|09/28/1990|||APPR|
N16895|S068|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PROFESSIONAL ASEPTOR DISINFECTING UNIT|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/1990|11/29/1990|||APPR|
N16895|S069|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PROFESSIONAL ASEPTOR DISINFECTING UNIT|LPM|OP|Normal 180 Day Track|Other Report|N|08/23/1990|12/19/1990|||APPR|
N16895|S070|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|~HFTLENS(R) (POLYMACON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|11/12/1991|||APPR|
N16895|S071|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFTLENS(R) (POLYMACON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|11/12/1991|||APPR|
N16895|S074|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFTLENS(R) (POLYMACON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/1991|08/13/1991|||APPR|
N16895|S075|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFTLENS(R) (POLYMACON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/1991|08/08/1991|||APPR|
N16895|S076|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|COMPACT DISINFECTING UNIT|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/1991|06/26/1992|||APPR|
N16895|S077|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/1991|10/30/1991|||APPR|
N16895|S079|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB CONTACT LENSES  RD-454(POLYMACON)|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/1991|03/03/1992|||APPR|
N16895|S080|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS(R) (POLYMACON) CONTACT LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1991|03/05/1992|||APPR|
N16895|S081|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS(R) (POLYMACON) CONTACT LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/1992|02/26/1993|||APPR|
N16895|S082|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB NATURAL TINT(TM) POLYMACON LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/1993|10/31/1994|||APPR|
N16895|S083|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB NATURAL TINT(TM) POLYMACON LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1994|02/23/1995|||APPR|
N16993|S001|ALCON LABORATORIES|P.O. BOX 289 4218 HOWARD AVE.||KENSINGTON|MD|20795||Accessories, soft lens products|ADAPPTE ARTIFICIAL TEAR|LPN|OP|||N|10/19/1979|03/21/1980|||APPR|
N16993|S002|ALCON LABORATORIES|P.O. BOX 289 4218 HOWARD AVE.||KENSINGTON|MD|20795||Accessories, soft lens products|ADAPPTE ARTIFICIAL TEAR|LPN|OP|||N|03/13/1980|03/27/1980|||APPR|
N16993|S003|ALCON LABORATORIES|P.O. BOX 289 4218 HOWARD AVE.||KENSINGTON|MD|20795||Accessories, soft lens products|ADSORBOTEAR(R)|LPN|OP|Normal 180 Day Track||N|02/02/1980|03/15/1982|||APPR|
N16993|S004|ALCON LABORATORIES|P.O. BOX 289 4218 HOWARD AVE.||KENSINGTON|MD|20795||Accessories, soft lens products|ADAPPTE ARTIFICIAL TEAR|LPN|OP|||N|05/05/1980|06/04/1980|||APPR|
N16993|S005|ALCON LABORATORIES|P.O. BOX 289 4218 HOWARD AVE.||KENSINGTON|MD|20795||Accessories, soft lens products|ADAPPTE ARTIFICIAL TEAR|LPN|OP|||N|06/19/1980|12/11/1980|||APPR|
N16993|S006|ALCON LABORATORIES|P.O. BOX 289 4218 HOWARD AVE.||KENSINGTON|MD|20795||Accessories, soft lens products|ADAPPTE ARTIFICIAL TEAR|LPN|OP|||N|03/30/1981|08/11/1981|||APPR|
N16993|S007|ALCON LABORATORIES|P.O. BOX 289 4218 HOWARD AVE.||KENSINGTON|MD|20795||Accessories, soft lens products|ADAPPTE ARTIFICIAL TEAR|LPN|OP|||N|07/14/1981|10/26/1981|||APPR|
N16993|S008|ALCON LABORATORIES|P.O. BOX 289 4218 HOWARD AVE.||KENSINGTON|MD|20795||Accessories, soft lens products|ADAPPTE ARTIFICIAL TEAR|LPN|OP|||N|08/27/1981|01/28/1982|||APPR|
N17003|S001|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX BONE CEMENT|LOD|OR|Normal 180 Day Track||N|03/03/1981|11/13/1981|||APPR|
N17003|S002|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1990|03/07/1991|||APPR|
N17003|S003|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/1991|10/01/1992|||APPR|
N17003|S004|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/1993|06/08/1993|||APPR|
N17004|S001|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX RADIOPAQUE BONE CEMENT|LOD|OR|||N|03/03/1981|11/13/1981|||APPR|
N17004|S002|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1990|03/07/1991|||APPR|
N17004|S003|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/1991|10/01/1992|||APPR|
N17004|S004|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/1993|12/30/1994|||APPR|
N17004|S005|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/1994|11/21/1995|||APPR|APPROVAL FOR CHANGE IN STERILIZATION OF SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT
N17004|S006|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/1994|02/24/1995|||APPR|
N17367|S001|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Sterilizer, soft-lens, thermal, ac-powered|HYDROCURVE PATIENT DISINFECTION UNIT|HRD|OP|||N|02/06/1979|08/21/1979|||APPR|
N17367|S005|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Sterilizer, soft-lens, thermal, ac-powered|HYDROCURVE PATIENT DISINFECTION UNIT|HRD|OP|||N|10/01/1974|10/01/1976|||APPR|
N17367|S009|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Sterilizer, soft-lens, thermal, ac-powered|HYDROCURVE PATIENT DISINFECTION UNIT|HRD|OP|||N|02/05/1980|03/26/1980|||APPR|
N17367|S011|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Sterilizer, soft-lens, thermal, ac-powered|HYDROCURVE PATIENT DISINFECTION UNIT|HRD|OP|||N|11/14/1983|11/14/1984|||APPR|
N17367|S012|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Sterilizer, soft-lens, thermal, ac-powered|SOFT MATE(R) DW (HEFILICON A) CONTACT LENS|HRD|OP|||N|12/20/1983|04/16/1984|||APPR|
N17367|S013|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Sterilizer, soft-lens, thermal, ac-powered|HYDROCURVE PATIENT DISINFECTION UNIT|HRD|OP|||N|03/04/1985|11/18/1986|||APPR|
N17375|S001|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON BANDAGE LENS|LPL|OP|||N|07/31/1979|08/21/1979|||APPR|
N17375|S002|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON BANDAGE LENS|LPL|OP|||N|11/14/1979|03/18/1980|||APPR|
N17375|S004|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON BANDAGE LENS|LPL|OP|||N|04/17/1980|01/27/1981|||APPR|
N17375|S007|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON BANDAGE LENS|LPL|OP|||N|01/17/1985|07/22/1985|||APPR|
N17375|S010|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON BANDAGE LENS|LPL|OP|||N|03/04/1986|05/21/1986|||APPR|
N17375|S011|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON BANDAGE LENS|LPL|OP|||N|03/18/1986|06/24/1986|||APPR|
N17472|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE DYED|GAN|SU|||N|11/17/1980|12/31/1980|||APPR|
N17472|S018|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|||N|04/23/1981|12/14/1981|||APPR|
N17472|S028|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRLY (POLYGLACTIN 910) SUTURE|GAN|SU|||N|10/21/1980|01/06/1981|||APPR|
N17472|S032|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910)SUTURE SHYTHETIC ABSORBABL|GAN|SU|||N|12/04/1980|07/07/1981|||APPR|
N17472|S033|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910)|GAN|SU|||N|02/11/1981|06/11/1981|||APPR|
N17472|S034|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|||N|05/19/1981|08/11/1981|||APPR|
N17472|S035|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|||N|03/04/1982|07/21/1982|||APPR|
N17472|S036|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|||N|05/13/1982|07/09/1982|||APPR|
N17472|S037|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|||N|12/20/1982|05/02/1984|||APPR|
N17472|S038|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|||N|05/05/1983|03/27/1984|||APPR|
N17472|S040|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N17472|S041|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N17472|S042|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/1987|08/28/1987|||APPR|
N17472|S043|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC|VICRYL (POLYGLACTIN 910) SUTURE|GAN|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/1987|10/05/1987|||APPR|
N17482|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICROL SYNTHETIC ABSORABLE SUTURE UNDYED||SU|||N|11/17/1980|12/31/1980|||APPR|
N17482|S013|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|||N|04/23/1981|12/14/1981|||APPR|
N17482|S023|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|||N|10/21/1980|01/06/1981|||APPR|
N17482|S027|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|||N|12/04/1980|07/07/1981|||APPR|
N17482|S028|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL (POLYGLACTIN 910)||SU|||N|02/11/1981|06/11/1981|||APPR|
N17482|S029|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|||N|05/19/1981|08/11/1981|||APPR|
N17482|S030|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|||N|03/04/1982|07/21/1982|||APPR|
N17482|S031|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|||N|12/20/1982|05/02/1984|||APPR|
N17482|S032|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|||N|05/05/1983|03/27/1984|||APPR|
N17482|S034|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N17482|S035|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876|||VICRYL MESH||SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N17511|S001|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|||N|04/22/1981|12/14/1981|||APPR|
N17511|S002|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|||N|08/18/1982|10/14/1982|||APPR|
N17511|S003|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|||N|09/10/1982|04/22/1983|||APPR|
N17511|S004|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|||N|03/30/1984|05/29/1987|||APPR|
N17511|S005|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|||N|03/30/1984|05/30/1984|||APPR|
N17511|S006|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|||N|01/11/1985|09/30/1985|||APPR|
N17511|S008|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|||N|02/03/1986|08/17/1987|||APPR|
N17511|S009|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1991|01/24/1992|||APPR|
N17511|S010|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/1993|07/18/1995|||APPR|APPROVAL FOR REVISED LABELING
N17511|S011|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/1994|07/18/1995|||APPR|APPROVAL FOR THE USE OF A LAGARDE STERILIZER, 551015, IN YOUR CLAYTON, N.C. FACILITY TO TERMINALLY STERILIZE HYSKON HYSTEROSCOPY FLUID, 32% (DEXTRAN 70) IN 100 ML TO 250 ML GLASS BOTTLE:TRANSFER OF OWNERSHIP TO MADISAN PHARMACEUTICALS, INC.
N17554|S003|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON CONTACT LENS|LPL|OP|||N|01/17/1985|07/01/1985|||APPR|
N17554|S005|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1986|09/21/1987|||APPR|
N17554|S006|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS|LPL|OP|||N|11/20/1985|03/17/1986|||APPR|
N17554|S007|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS|LPL|OP|||N|03/04/1986|05/21/1986|||APPR|
N17554|S008|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS|LPL|OP|||N|03/18/1986|06/24/1986|||APPR|
N17554|S011|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1988|01/12/1989|||APPR|
N17554|S012|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/1989|01/31/1990|||APPR|
N17600|S001|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|||N|01/28/1980|04/22/1981|||APPR|
N17600|S002|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|||N|06/16/1980|12/23/1980|||APPR|
N17600|S003|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|||N|07/08/1980|12/18/1980|||APPR|
N17600|S004|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|||N|07/21/1980|03/31/1981|||APPR|
N17600|S005|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|||N|08/20/1981|11/03/1981|||APPR|
N17600|S007|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|||N|02/02/1982|04/02/1982|||APPR|
N17600|S008|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|||N|08/26/1983|11/17/1983|||APPR|
N17600|S009|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|Special (Immediate Track)|Other Report|N|09/16/1986|10/24/1986|||APPR|
N17600|S010|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/1991|08/12/1994|||APPR|
N17600|S011|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1993|09/29/1993|||APPR|
N17600|S012|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/1994|01/20/1995|||APPR|
N17654|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|01/19/1979|03/01/1980|||APPR|
N17654|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|02/26/1979|03/14/1980|||APPR|
N17654|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|05/22/1981|07/31/1981|||APPR|
N17654|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|05/04/1982|08/10/1983|||APPR|
N17654|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|10/25/1982|01/27/1983|||APPR|
N17654|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|12/14/1983|05/02/1984|||APPR|
N17654|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|12/14/1983|07/24/1984|||APPR|
N17654|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|03/08/1984|05/23/1986|||APPR|
N17654|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|04/30/1984|12/17/1984|||APPR|
N17654|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|06/12/1984|05/08/1986|||APPR|
N17654|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|11/20/1984|02/17/1987|||APPR|
N17654|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|11/20/1984|12/22/1986|||APPR|
N17654|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|||N|02/25/1986|07/15/1988|||APPR|
N17654|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/1986|07/31/1986|||APPR|
N17654|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1987|04/16/1987|||APPR|
N17654|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/17/1987|02/10/1988|||APPR|
N17654|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/17/1987|03/15/1988|||APPR|
N17654|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/16/1988|11/01/1988|||APPR|
N17676|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|12/19/1978|02/26/1979|||APPR|
N17676|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|04/20/1979|08/31/1979|||APPR|
N17676|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|06/25/1979|08/06/1979|||APPR|
N17676|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|06/26/1979|01/30/1980|||APPR|
N17676|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|09/17/1979|11/02/1979|||APPR|
N17676|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|MIRACON(TM) (HEFILCON B)|LPL|OP|Special (Immediate Track)||N|06/16/1980|06/16/1980|||APPR|
N17676|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|MIRACON (HEFILCON B) TORIC CONTACT LENS|LPL|OP|||N|02/26/1981|09/29/1981|||APPR|
N17676|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|11/02/1983|06/10/1985|||APPR|
N17676|S009|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|12/20/1983|04/16/1984|||APPR|
N17676|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|05/08/1984|05/02/1985|||APPR|
N17676|S011|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|05/17/1984|05/02/1985|||APPR|
N17676|S012|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|05/21/1984|05/02/1985|||APPR|
N17676|S013|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|06/22/1984|05/30/1985|||APPR|
N17676|S014|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|06/14/1985|01/10/1986|||APPR|
N17676|S015|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|||N|08/30/1985|03/04/1986|||APPR|
N17676|S016|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1987|05/08/1987|||APPR|
N17676|S017|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/1987|09/11/1990|||APPR|
N17676|S018|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/14/1988|03/09/1989|||APPR|
N17676|S019|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|NATUREVUE CONTACT LENSE|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/1989|03/06/1990|||APPR|
N17676|S020|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|11/12/1991|||APPR|
N17676|S021|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|11/12/1991|||APPR|
N17676|S022|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/15/1990|02/07/1991|||APPR|
N17676|S024|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|BAUSCH & LOMB (HEFILCON C) CONTACT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1990|07/02/1993|||APPR|
N17676|S025|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|BAUSCH & LOMB (HEFILCON C) CONTACT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/1990|07/02/1991|||APPR|
N17676|S027|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|BAUSCH & LOMB (HEFILCON C) CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/1991|10/30/1991|||APPR|
N17679|S001|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|05/01/1979|08/09/1979|||APPR|
N17679|S003|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|01/08/1980|11/07/1980|||APPR|
N17679|S006|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|07/02/1984|02/25/1986|||APPR|
N17679|S007|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|08/07/1984|12/17/1985|||APPR|
N17679|S008|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|12/21/1984|10/30/1985||02/14/1986|APPR|
N17679|S009|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|05/30/1985|03/10/1986|||APPR|
N17679|S010|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|01/06/1986|03/31/1986|||APPR|
N17679|S011|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|01/08/1986|03/31/1986|||APPR|
N17679|S012|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUASEPT II|LPM|OP|||N|03/03/1986|08/27/1986|||APPR|
N17679|S013|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUAFLEX HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/1987|12/14/1987|||APPR|
N17679|S014|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|QUASEPT II|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/1987|10/27/1987|||APPR|
N17679|S015|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUAFLEX HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/1987|03/15/1988|||APPR|
N17679|S016|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|QUASEPT II|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/1987|12/01/1987|||APPR|
N17679|S017|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|QUASEPT II|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/24/1988|05/10/1988|||APPR|
N17679|S018|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|QUASEPT II|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/1988|08/11/1988|||APPR|
N17679|S019|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|QUASEPT II|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/1989|08/11/1989|||APPR|
N17679|S020|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUAFLEX|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1989|09/06/1989|||APPR|
N17679|S021|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|AQUAFLEX|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|12/28/1989|||APPR|
N17679|S022|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|PERMAFLEX THIN & THIN COLOR COLLECTION|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/1990|09/14/1990|||APPR|
N17679|S023|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|PERMAFLEX THIN & THIN COLOR COLLECTION|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/1990|01/10/1991|||APPR|
N17679|S024|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|VANTAGE & VANTAGE THIN (TETRAFILCON A) CONTACT LEN|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/1990|08/29/1991|||APPR|
N17679|S025|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|VANTAGE & VANTAGE THIN (TETRAFILCON A) CONTACT LEN|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/1991|09/13/1991|||APPR|
N17679|S027|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|VANTAGE (TETRAFILCON A ) CONTACT LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1993|11/23/1993|||APPR|
N17679|S028|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|VANTAGE (TETRAFILCON A ) CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/1993|05/10/1994|||APPR|
N17722|S001|DOW CORNING OPHTHALMICS, INC.|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|GELFLEX(R) (DIMEFILCON A) CONTACT LENS|LPL|OP|||N|02/14/1979|03/01/1979|||APPR|
N17722|S002|DOW CORNING OPHTHALMICS, INC.|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|GELFLEX(R) (DIMEFILCON A) CONTACT LENS|LPL|OP|||N|06/20/1979|08/21/1979|||APPR|
N17722|S003|DOW CORNING OPHTHALMICS, INC.|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|GELFLEX(R) (DIMEFILCON A) CONTACT LENS|LPL|OP|||N|04/17/1979|08/31/1979|||APPR|
N17722|S004|DOW CORNING OPHTHALMICS, INC.|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|GELFLEX(R) (DIMEFILCON A) CONTACT LENS|LPL|OP|||N|10/30/1979|03/14/1980|||APPR|
N17722|S005|DOW CORNING OPHTHALMICS, INC.|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|GELFLEX(R) (DIMEFILCON A) CONTACT LENS|LPL|OP|||N|07/23/1981|02/26/1982|||APPR|
N17734|S002|STRIETER LABORATORIES, INC.|222 VANDALIA ST.||COLLINSVILLE|IL|62234||Lenses, soft contact, daily wear|ACCUSEPT DISINFECTING UNIT|LPL|OP|||N|01/20/1982|03/05/1982|||APPR|
N17734|S003|STRIETER LABORATORIES, INC.|222 VANDALIA ST.||COLLINSVILLE|IL|62234||Lenses, soft contact, daily wear|ACCUGEL 1T|LPL|OP|||N|02/15/1984|07/13/1984|||APPR|
N17734|S004|STRIETER LABORATORIES, INC.|222 VANDALIA ST.||COLLINSVILLE|IL|62234||Lenses, soft contact, daily wear|ACCUSEPT DISINFECTING UNIT|LPL|OP|||N|11/19/1984|08/15/1985|||APPR|
N17734|S005|STRIETER LABORATORIES, INC.|222 VANDALIA ST.||COLLINSVILLE|IL|62234||Lenses, soft contact, daily wear|ACCUSEPT DISINFECTING UNIT|LPL|OP|||N|09/05/1985|03/17/1986|||APPR|
N17752|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|11/16/1978|03/31/1979||03/14/1980|APPR|
N17752|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|08/03/1979|11/13/1979|||APPR|
N17752|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|08/10/1979|03/14/1980|||APPR|
N17752|S005|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|08/10/1979|01/11/1980|||APPR|
N17752|S006|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|01/08/1980|01/14/1981||03/20/1981|APPR|
N17752|S007|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|02/15/1980|08/05/1980|||APPR|
N17752|S008|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|03/26/1980|06/16/1980|||APPR|
N17752|S009|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|06/06/1980|08/05/1980|||APPR|
N17752|S010|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE II|LPL|OP|||N|11/04/1980|03/05/1982|||APPR|
N17752|S012|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE II (BUFILCON A) CONTACT LENSES|LPL|OP|||N|04/07/1981|02/05/1982|||APPR|
N17752|S013|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVEII (BUFILCON A) CONTACT LENSES|LPL|OP|||N|04/06/1981|08/19/1981|||APPR|
N17752|S014|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE II (BUFILCON A) CONTACT LENSES|LPL|OP|||N|04/14/1981|06/04/1981|||APPR|
N17752|S015|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|07/07/1982|10/03/1983|||APPR|
N17752|S016|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE II BIFOCAL LENS|LPL|OP|||N|06/13/1983|01/28/1985||03/22/1985|APPR|
N17752|S017|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|06/24/1983|03/15/1985|||APPR|
N17752|S018|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|10/06/1983|07/31/1984|||APPR|
N17752|S019|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|10/26/1983|01/12/1984|||APPR|
N17752|S020|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|08/24/1984|06/19/1985|||APPR|
N17752|S021|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|09/14/1984|08/13/1986|||APPR|
N17752|S022|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|02/04/1985|08/28/1985|||APPR|
N17752|S023|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|02/04/1985|01/10/1986|||APPR|
N17752|S024|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|05/20/1985|10/10/1985|||APPR|
N17752|S025|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|11/04/1985|06/20/1986|||APPR|
N17752|S026|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|||N|04/29/1986|07/11/1986|||APPR|
N17752|S027|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/05/1987|02/25/1988|||APPR|
N17752|S028|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|Normal 180 Day Track|Other Report|N|01/12/1987|04/14/1988|||APPR|
N17752|S029|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/1987|06/10/1987|||APPR|
N17752|S030|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/1987|10/27/1987|||APPR|
N17752|S031|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/1987|02/24/1988|||APPR|
N17752|S032|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/17/1989|11/21/1989|||APPR|
N17752|S033|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/23/1990|||APPR|
N17752|S034|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1989|09/08/1989|||APPR|
N17752|S035|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/1994|11/09/1994|||APPR|
N17755|S019|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|09/01/1980|02/26/1981|||APPR|
N17755|S021|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|05/22/1981|06/16/1981|||APPR|
N17755|S022|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|06/29/1981|09/01/1981|||APPR|
N17755|S024|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|02/11/1982|07/23/1982|||APPR|
N17755|S025|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|07/07/1982|07/27/1982|||APPR|
N17755|S026|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|08/06/1982|09/29/1982|||APPR|
N17755|S027|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|08/18/1982|09/22/1982|||APPR|
N17755|S028|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|10/26/1982|11/23/1982|||APPR|
N17755|S029|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|01/03/1983|01/27/1983|||APPR|
N17755|S031|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|||N|08/24/1984|12/20/1984|||APPR|
N17755|S033|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|Normal 180 Day Track|Other Report|N|09/03/1986|10/14/1986|||APPR|
N17755|S034|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|THIRTY DAY TRACK|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1988|04/28/1988|||APPR|
N17755|S035|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/08/1990|08/02/1990|||APPR|
N17755|S036|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/1990|06/04/1990|||APPR|
N17755|S037|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|BONECEMENT|LOD|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/1990|05/22/1990|||APPR|
N17755|S039|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/1992|10/22/1992|||APPR|
N17755|S040|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT|LOD|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/1992|07/27/1992|||APPR|
N17755|S041|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1992|11/25/1992|||APPR|
N17755|S042|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/1994|06/09/1995|||APPR|
N17755|S043|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT|LOD|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/1994|08/12/1994|||APPR|
N17755|S044|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|OSTEOBOND(TM) COPOLYMER BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1994|08/11/1995|||APPR|CHANGES IN THE BONE CEMENT COMPOSITION TRADE NAME:OSTEOBOND COPOLYMER BONE CEMENT
N17786|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) CLEANING & DISINFECTING SOLUTION|LPN|OP|||N|11/07/1980|07/07/1981|||APPR|
N17786|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING AND SOAKING SOL.|LPN|OP|||N|11/07/1980|08/20/1982|||APPR|
N17786|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING AND SOAKING SOL.|LPN|OP|||N|02/12/1981|05/29/1981|||APPR|
N17786|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING AND SOAKING SOL.|LPN|OP|||N|05/19/1981|07/31/1981|||APPR|
N17786|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING AND SOAKING SOL.|LPN|OP|||N|07/28/1981|09/22/1981|||APPR|
N17786|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|||N|03/04/1982|04/09/1986|||APPR|
N17786|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|||N|03/29/1982|09/14/1982|||APPR|
N17786|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|||N|04/12/1982|05/26/1982|||APPR|
N17786|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|||N|05/06/1982|07/16/1982|||APPR|
N17786|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|||N|06/07/1982|09/14/1982|||APPR|
N17786|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|||N|09/29/1982|10/26/1982|||APPR|
N17786|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|||N|04/23/1984|11/29/1984|||APPR|
N17786|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|||N|06/04/1984|11/29/1984|||APPR|
N17786|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1987|04/08/1987|||APPR|
N17786|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/1988|03/14/1988|||APPR|
N17786|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
N17786|S021|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/15/1989|10/17/1989|||APPR|
N17786|S022|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTLENS CLEANING & DISINFECTING SOLN.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
N17793|S001|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFT SITE (HEFICON A)|LPL|OP|||N|10/22/1979|04/22/1980|||APPR|
N17793|S003|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFT SITE (HEFILCON A) CONTACT LENS|LPL|OP|||N|05/28/1980|10/30/1980|||APPR|
N17793|S004|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFT SITE (HEFILCON A) CONTACT LENS|LPL|OP|||N|11/06/1980|06/25/1981|||APPR|
N17793|S005|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|||N|01/08/1982|03/03/1982|||APPR|
N17793|S006|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|||N|07/11/1983|09/30/1985||11/21/1985|APPR|
N17793|S008|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|||N|11/04/1983|02/15/1984|||APPR|
N17793|S009|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|||N|08/19/1985|11/18/1985|||APPR|
N17793|S010|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|||N|09/16/1985|01/22/1986|||APPR|
N17793|S011|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|||N|09/16/1985|03/03/1986|||APPR|
N17793|S012|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/1986|12/04/1986|||APPR|
N17793|S013|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/1987|10/05/1987|||APPR|
N17793|S014|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|SOFTSITE (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/1987|10/05/1987|||APPR|
N17804|S001|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|11/19/1980|01/06/1981|||APPR|
N17804|S003|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND* POLYESTER SUTURE (DYED) NONABSORBAB|GAS|SU|||N|12/04/1980|07/07/1981|||APPR|
N17804|S023|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|10/21/1980|01/06/1981|||APPR|
N17804|S024|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND POLYESTER NONABSORBABLE SURG. SUTURE|GAS|SU|||N|02/11/1981|06/11/1981|||APPR|
N17804|S025|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|05/19/1981|08/11/1981|||APPR|
N17804|S026|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|05/19/1981|08/11/1981|||APPR|
N17804|S027|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|02/11/1982|11/15/1982|||APPR|
N17804|S028|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|03/04/1982|07/21/1982|||APPR|
N17804|S029|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|12/20/1982|05/02/1984|||APPR|
N17804|S030|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|02/16/1983|06/07/1983|||APPR|
N17804|S031|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|04/20/1983|07/14/1983|||APPR|
N17804|S032|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|05/05/1983|03/27/1984|||APPR|
N17804|S033|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|08/24/1984|02/28/1985|||APPR|
N17804|S034|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|10/21/1985|06/20/1986|||APPR|
N17804|S035|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N17804|S036|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1987|06/18/1987|||APPR|
N17804|S037|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/1987|08/28/1987|||APPR|
N17804|S038|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1988|12/22/1988|||APPR|
N17809|S001|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|11/19/1980|01/06/1981|||APPR|
N17809|S002|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|12/04/1980|07/07/1981|||APPR|
N17809|S003|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|05/19/1981|08/11/1981|||APPR|
N17809|S004|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|02/11/1982|11/15/1982|||APPR|
N17809|S005|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|03/04/1982|07/21/1982|||APPR|
N17809|S006|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|12/20/1982|05/02/1984|||APPR|
N17809|S007|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|02/16/1983|06/07/1983|||APPR|
N17809|S008|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|04/20/1983|07/14/1983|||APPR|
N17809|S009|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|05/05/1983|03/27/1984|||APPR|
N17809|S010|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|08/24/1984|02/28/1985|||APPR|
N17809|S011|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|||N|10/21/1985|06/20/1986|||APPR|
N17809|S012|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Suture, nonabsorbable, synthetic, polyester|ETHIBOND*|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N17825|S001|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|||N|11/24/1980|01/06/1981|||APPR|
N17825|S008|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE POLYPROPYLEME NONABSORBABLESUTURES|GAT|SU|||N|12/01/1980|01/30/1981|||APPR|
N17825|S009|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|||N|07/06/1981|09/24/1981|||APPR|
N17825|S010|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|||N|06/17/1982|07/16/1982|||APPR|
N17825|S011|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|||N|06/17/1982|07/16/1982|||APPR|
N17825|S012|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|||N|07/08/1981|06/30/1983|||APPR|
N17825|S013|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|||N|02/06/1984|03/12/1984|||APPR|
N17825|S014|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|||N|07/02/1985|08/23/1985|||APPR|
N17825|S015|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1987|06/05/1987|||APPR|
N17825|S016|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1988|03/01/1988|||APPR|
N17825|S017|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|SURGILENE|GAT|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/1988|06/06/1988|||APPR|
N17852|S001|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|12/11/1978|09/13/1979|||APPR|
N17852|S002|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|10/12/1979|03/18/1980|||APPR|
N17852|S003|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|07/08/1980|10/17/1980|||APPR|
N17852|S004|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|09/02/1980|02/20/1981|||APPR|
N17852|S005|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT SX4 & DURASOFT SX4 (PHEMFILCON A )|LPL|OP|||N|02/02/1981|09/04/1981|||APPR|
N17852|S006|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|05/27/1981|08/27/1982|||APPR|
N17852|S007|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|11/12/1981|08/27/1982|||APPR|
N17852|S008|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT(R) TRUFOCAL(TM)|LPL|OP|||N|07/22/1982|04/20/1983||06/03/1983|APPR|
N17852|S009|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|12/30/1982|02/28/1983|||APPR|
N17852|S010|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|03/01/1983|08/04/1983|||APPR|
N17852|S011|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|09/12/1983|12/08/1983|||APPR|
N17852|S012|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|11/21/1984|11/05/1985|||APPR|
N17852|S013|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT(R) 2 BIFOCAL|LPL|OP|||N|01/04/1985|06/19/1985|||APPR|
N17852|S014|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|||N|11/04/1985|12/13/1985|||APPR|
N17852|S015|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track||N|03/10/1986|04/10/1987|||APPR|
N17852|S016|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/08/1986|11/12/1986|||APPR|
N17852|S017|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/22/1987|06/26/1987|||APPR|
N17852|S018|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/22/1987|07/07/1987|||APPR|
N17852|S019|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/1987|07/01/1987|||APPR|
N17852|S020|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/1987|09/17/1987|||APPR|
N17852|S021|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/1987|10/07/1987|||APPR|
N17852|S022|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/1987|11/30/1988|||APPR|
N17852|S023|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1987|11/30/1988|||APPR|
N17852|S024|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/1987|08/10/1987|||APPR|
N17852|S025|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/1987|11/03/1987|||APPR|
N17852|S026|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1988|08/31/1988|||APPR|
N17852|S027|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1988|05/05/1989|||APPR|
N17852|S028|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1989|08/28/1989|||APPR|
N17852|S029|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1989|06/01/1989|||APPR|
N17852|S030|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/1989|11/02/1989|||APPR|
N17852|S031|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|08/29/1990|||APPR|
N17852|S032|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENSES /SHELF LIFE|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/1989|03/05/1990|||APPR|
N17852|S033|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Lenses, soft contact, daily wear|DURASOFT CONTACT LENSES /SHELF LIFE|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/1991|10/04/1991|||APPR|
N17855|S001|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|TRESOFT SOFT CONTACT LENSE|LPL|OP|||N|06/24/1979|10/02/1979|||APPR|
N17855|S002|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|TRESOFT SOFT CONTACT LENSE|LPL|OP|||N|10/04/1979|05/05/1980|||APPR|
N17855|S003|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|TRESOFT SOFT CONTACT LENSE|LPL|OP|||N|05/10/1982|07/15/1982|||APPR|
N17855|S004|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|TRESOFT SOFT CONTACT LENSE|LPL|OP|||N|11/04/1983|03/29/1984|||APPR|
N17855|S005|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|TRESOFT SOFT CONTACT LENSE|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/1986|09/15/1986|||APPR|
N17855|S006|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|TRESOFT SOFT CONTACT LENSE|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/1987|06/08/1988|||APPR|
N17878|S001|DANKER LABORATORIES, INC.|2202 SOUTH PRIEST DR.||TEMPLE|AZ|85282||Lens, contact (other material) - daily|MESO(CELLULOSE ACETATE BUTYRATE) HARD CONTACT LENS|HQD|OP|Normal 180 Day Track||N|09/02/1980|02/24/1981|||APPR|
N17908|S001|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|01/31/1977|05/12/1977|||APPR|
N17908|S003|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|SOLUTION|LPN|OP|||N|06/19/1979|07/10/1979|||APPR|
N17908|S004|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK|LPN|OP|||N|06/19/1979|08/13/1979|||APPR|
N17908|S006|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|06/04/1979|06/26/1979|||APPR|
N17908|S007|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|06/18/1979|07/10/1979|||APPR|
N17908|S013|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|05/03/1979|05/29/1979|||APPR|
N17908|S014|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|04/21/1980|08/06/1980|||APPR|
N17908|S018|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|07/24/1979|08/17/1979|||APPR|
N17908|S019|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|08/24/1979|11/02/1979|||APPR|
N17908|S020|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|09/06/1979|10/12/1979|||APPR|
N17908|S021|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|11/28/1979|01/30/1980|||APPR|
N17908|S022|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|04/07/1980|03/15/1982|||APPR|
N17908|S023|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|04/25/1980|06/19/1980|||APPR|
N17908|S024|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|05/05/1980|11/14/1980|||APPR|
N17908|S025|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|05/06/1980|11/12/1980|||APPR|
N17908|S026|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|Special (Immediate Track)||N|05/16/1980|05/16/1980|||APPR|
N17908|S027|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|06/19/1980|12/11/1980|||APPR|
N17908|S028|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|09/02/1980|02/13/1981|||APPR|
N17908|S029|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|09/02/1980|02/09/1981|||APPR|
N17908|S032|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|11/13/1981|03/15/1982|||APPR|
N17908|S033|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|03/23/1982|04/26/1982|||APPR|
N17908|S034|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|04/01/1983|08/24/1983|||APPR|
N17908|S035|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|12/08/1983|11/02/1984|||APPR|
N17908|S036|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|06/05/1984|06/20/1985|||APPR|
N17908|S037|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|07/18/1984|05/03/1985|||APPR|
N17908|S038|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|09/04/1984|05/09/1985|||APPR|
N17908|S039|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|ALCON SALINE SOLUTION FOR SENSITIVE EYES|LPN|OP|||N|05/29/1984|12/06/1985|||APPR|
N17908|S040|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|||N|12/26/1984|11/12/1986|||APPR|
N17908|S041|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1988|02/21/1989|||APPR|
N17908|S042|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1989|06/26/1989|||APPR|
N17908|S043|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|BOIL N SOAK CONTACT LENS FLUID|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/1990|03/05/1990|||APPR|
N17908|S045|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|SOFT MATE SALINE SOLUTION / SENSITIVE EYES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/1993|09/09/1994|||APPR|
N17908|S046|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|SOFT MATE SALINE SOLUTION / SENSITIVE EYES|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
N17945|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|09/06/1979|10/12/1979|||APPR|
N17945|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Special (Immediate Track)||N|09/06/1979|09/06/1979|||APPR|
N17945|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|09/06/1979|10/12/1979|||APPR|
N17945|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|04/07/1980|03/15/1982|||APPR|
N17945|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|05/05/1980|11/14/1980|||APPR|
N17945|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|06/19/1980|12/11/1980|||APPR|
N17945|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES STERILE LUBRICATING & REWETTING SOLN|LPN|OP|||N|09/02/1980|02/25/1981|||APPR|
N17945|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|09/16/1980|03/02/1981|||APPR|
N17945|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|03/05/1981|09/30/1981|||APPR|
N17945|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Normal 180 Day Track||N|08/28/1981|01/28/1982|||APPR|
N17945|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|04/01/1983|08/24/1983|||APPR|
N17945|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|12/08/1983|11/02/1984|||APPR|
N17945|S018|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|07/18/1984|06/07/1985|||APPR|
N17945|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Normal 180 Day Track||N|07/30/1984|12/13/1985|||APPR|
N17945|S020|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES LUBRICATION & REWETTING SOLN FOR SENSITI|LPN|OP|||N|12/10/1984|12/20/1985|||APPR|
N17945|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|||N|07/17/1985|08/13/1985|||APPR|
N17945|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1987|12/13/1988|||APPR|
N17945|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1987|03/14/1988|||APPR|
N17945|S024|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/1989|06/01/1989|||APPR|
N17945|S025|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/1989|10/16/1989|||APPR|
N17945|S027|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
N17951|S001|APPLIED OPTICS, INC.|4218 HOWARD AVE.||KENSINGTON|MD|20895||Lenses, soft contact, daily wear|TRI POL 43 CONTACT LENS|LPL|OP|||N|12/12/1978|03/23/1979|||APPR|
N17951|S002|APPLIED OPTICS, INC.|4218 HOWARD AVE.||KENSINGTON|MD|20895||Lenses, soft contact, daily wear|TRI POL 43 CONTACT LENS|LPL|OP|||N|12/26/1978|02/26/1979|||APPR|
N17951|S003|APPLIED OPTICS, INC.|4218 HOWARD AVE.||KENSINGTON|MD|20895||Lenses, soft contact, daily wear|TRI POL 43 CONTACT LENS|LPL|OP|||N|09/16/1979|01/30/1980|||APPR|
N17974|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETLE|LPN|OP|||N|03/23/1979|05/22/1979|||APPR|
N17974|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|03/12/1979|08/13/1980|||APPR|
N17974|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|06/24/1979|08/13/1979|||APPR|
N17974|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|07/23/1979|08/17/1979|||APPR|
N17974|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|08/29/1979|01/30/1980|||APPR|
N17974|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|09/06/1979|10/12/1979|||APPR|
N17974|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|11/28/1979|01/30/1980|||APPR|
N17974|S020|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|04/07/1980|03/15/1982|||APPR|
N17974|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|04/25/1980|06/19/1980|||APPR|
N17974|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|05/05/1980|11/14/1980|||APPR|
N17974|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|08/05/1980|11/12/1980|||APPR|
N17974|S024|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|Special (Immediate Track)||N|05/16/1980|05/16/1980|||APPR|
N17974|S025|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|06/19/1980|12/11/1980|||APPR|
N17974|S026|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|09/03/1980|02/26/1981|||APPR|
N17974|S027|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX STERILE CLEANING SOLM|LPN|OP|||N|09/02/1980|02/25/1981|||APPR|
N17974|S028|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|09/16/1980|03/02/1981|||APPR|
N17974|S029|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX|LPN|OP|||N|03/05/1981|09/30/1981|||APPR|
N17974|S030|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|04/01/1983|08/24/1983|||APPR|
N17974|S032|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|08/27/1981|01/28/1982|||APPR|
N17974|S034|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|03/23/1982|04/26/1982|||APPR|
N17974|S036|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|12/08/1983|11/02/1984|||APPR|
N17974|S037|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|12/14/1983|06/29/1984|||APPR|
N17974|S038|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|06/08/1984|06/20/1985|||APPR|
N17974|S039|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|07/18/1984|06/30/1985|||APPR|
N17974|S040|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEXSOL|LPN|OP|||N|07/18/1984|12/13/1985|||APPR|
N17974|S041|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES|LPN|OP|||N|12/10/1984|12/20/1985|||APPR|
N17974|S042|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/1987|12/13/1988|||APPR|
N17974|S043|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1987|02/23/1988|||APPR|
N17974|S044|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/1988|03/29/1989|||APPR|
N17974|S047|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
N17976|S001|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lenses, soft contact, daily wear|FLEXLENS|LPL|OP|||N|05/19/1980|10/28/1980|||APPR|
N17976|S002|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lenses, soft contact, daily wear|FLEXLENS|LPL|OP|||N|06/03/1982|12/02/1982|||APPR|
N17976|S003|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lenses, soft contact, daily wear|FLEXLENS|LPL|OP|||N|04/27/1984|12/10/1984|||APPR|
N17976|S004|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lenses, soft contact, daily wear|FLEXLENS|LPL|OP|Normal 180 Day Track|Other Report|N|09/24/1987|04/04/1988|||APPR|
N17976|S005|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lenses, soft contact, daily wear|FLEXLENS|LPL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1987|05/13/1988|||APPR|
N17976|S008|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lenses, soft contact, daily wear|FLEXLENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/1989|01/16/1990|||APPR|
N17976|S010|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lenses, soft contact, daily wear|FLEXENS (HEFILCON A) SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1990|07/12/1990|||APPR|
N17985|S001|ORGANON, INC.|9440 TELSTAR AVENUE, SUITE 7||EL MONTE|CA|91731||KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE|GONOSTICON DRI-DOT|JSX|MI|||N|02/23/1981|04/14/1981|||APPR|
N17985|S002|ORGANON, INC.|9440 TELSTAR AVENUE, SUITE 7||EL MONTE|CA|91731||KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE|GONOSTICON DRI-DOT TEST|JSX|MI|||N|11/29/1982|01/04/1983|||APPR|
N17987|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|09/14/1979|09/30/1980|||APPR|
N17987|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|11/15/1979|12/30/1981|||APPR|
N17987|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|11/17/1980|06/11/1981|||APPR|
N17987|S006|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|11/12/1981|03/03/1982|||APPR|
N17987|S007|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|01/17/1983|12/16/1983||01/17/1984|APPR|
N17987|S008|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|03/30/1983|06/30/1983|||APPR|
N17987|S009|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|07/28/1983|10/25/1983|||APPR|
N17987|S010|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|01/25/1984|04/17/1987|||APPR|
N17987|S011|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|09/24/1984|12/18/1985|||APPR|
N17987|S012|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|04/02/1985|10/10/1985|||APPR|
N17987|S013|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|||N|12/10/1985|04/14/1986|||APPR|
N17987|S014|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Other Report|N|05/26/1987|06/16/1987|||APPR|
N17987|S015|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1987|07/31/1987|||APPR|
N17987|S016|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/1987|05/12/1988|||APPR|
N17987|S017|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/13/1988|09/27/1989|||APPR|
N17987|S018|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/1988|12/15/1988|||APPR|
N17987|S019|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1988|10/04/1989|||APPR|
N17987|S020|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/23/1990|||APPR|
N17987|S021|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/1989|09/18/1989|||APPR|
N17987|S024|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|CSI COLOURS CONTACT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1992|06/22/1993|||APPR|
N18001|S002|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|MINITHEERM|LPL|OP|||N|03/02/1979|08/08/1979|||APPR|
N18001|S003|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|TETRAFILCON A HYDROPHILIC CONTACT LENS|LPL|OP|||N|09/22/1980|11/13/1981|||APPR|
N18001|S004|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|MINITHEERM|LPL|OP|||N|09/18/1981|04/19/1982|||APPR|
N18001|S005|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|MINITHEERM|LPL|OP|||N|02/12/1982|04/19/1982|||APPR|
N18001|S006|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|MINITHEERM|LPL|OP|||N|01/17/1985|07/22/1985|||APPR|
N18001|S008|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|MINITHEERM|LPL|OP|||N|03/04/1986|05/21/1986|||APPR|
N18001|S009|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|MINITHEERM|LPL|OP|||N|03/18/1986|08/04/1986|||APPR|
N18018|S001|LOMBART OPTICAL OF VIRGINIA, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23501||Lenses, soft contact, daily wear|ARMSOF SOFT CONTACT LENSE|LPL|OP|||N|12/01/1978|05/07/1979|||APPR|
N18018|S002|LOMBART OPTICAL OF VIRGINIA, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23501||Lenses, soft contact, daily wear|ARMSOF SOFT CONTACT LENSE|LPL|OP|||N|06/28/1979|09/26/1979|||APPR|
N18018|S003|LOMBART OPTICAL OF VIRGINIA, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23501||Lenses, soft contact, daily wear|ARMSOF SOFT CONTACT LENSE|LPL|OP|||N|12/31/1979|05/21/1980|||APPR|
N18018|S004|LOMBART OPTICAL OF VIRGINIA, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23501||Lenses, soft contact, daily wear|ARMSOF SOFT CONTACT LENSE|LPL|OP|||N|04/09/1984|11/29/1984|||APPR|
N18020|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|08/17/1979|11/02/1979|||APPR|
N18020|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|01/02/1980|05/22/1980|||APPR|
N18020|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|01/15/1980|08/05/1980|||APPR|
N18020|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|09/23/1980|03/02/1981|||APPR|
N18020|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|09/23/1980|07/27/1982|||APPR|
N18020|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|B & L STERILE PRESERVED SALINE SOLUTION|LPN|OP|||N|05/05/1980|04/01/1981|||APPR|
N18020|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|12/15/1980|04/19/1982|||APPR|
N18020|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|06/22/1981|03/15/1982|||APPR|
N18020|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|04/12/1982|05/26/1982|||APPR|
N18020|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SORBI-CARE(TM) SALINE SOLN|LPN|OP|||N|04/30/1982|07/05/1983|||APPR|
N18020|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|12/07/1982|04/27/1983|||APPR|
N18020|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|11/01/1983|10/23/1985|||APPR|
N18020|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|04/23/1984|11/29/1984|||APPR|
N18020|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN PRESERVED SALINE SOLUTION|LPN|OP|||N|06/04/1984|11/29/1984|||APPR|
N18020|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|||N|09/05/1984|12/02/1986|||APPR|
N18020|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1987|09/28/1987|||APPR|
N18020|S022|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1987|04/08/1987|||APPR|
N18020|S023|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/1987|05/09/1988|||APPR|
N18020|S024|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/1988|04/06/1988|||APPR|
N18020|S025|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
N18020|S026|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/1988|11/21/1988|||APPR|
N18020|S027|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/1989|05/02/1989|||APPR|
N18020|S028|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1989|10/16/1989|89M-0471|11/22/1989|APPR|
N18020|S029|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/1989|10/13/1989|||APPR|
N18020|S030|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
N18020|S031|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/1989|01/22/1990|||APPR|
N18020|S032|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS FRESH(TM) LUBRICATING & REWETTING SOLN|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/04/1989|02/16/1990|||APPR|
N18020|S033|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS STERILE SALINE SOLUTION (BUFFERED)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/1990|05/08/1990|||APPR|
N18020|S034|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS STERILE SALINE SOLUTION (BUFFERED)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/1990|03/06/1991|||APPR|
N18020|S035|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS STERILE SALINE SOLUTION (BUFFERED)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/1990|02/05/1991|||APPR|
N18020|S036|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) PRESERVED SALINE SOL. (0.005% PURITE)|LPN|OP|Normal 180 Day Track|Other Report|N|10/09/1990|07/15/1991|||APPR|
N18020|S037|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) PRESERVED SALINE SOL. (0.005% PURITE)|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/1990|05/28/1991|||APPR|
N18020|S038|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/1993|06/29/1993|||APPR|
N18032|S001|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|CABCURVE CONTACT LENS (POROFOCOM B)|HPX|OP|||N|11/05/1979|07/31/1980|||APPR|
N18032|S002|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|CABCURVE CONTACT LENS (POROFOCON B)|HPX|OP|||N|12/16/1980|03/03/1982|||APPR|
N18032|S003|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|CABCURVE (POROFOCAN B)|HPX|OP|||N|12/14/1981|03/01/1982|||APPR|
N18032|S004|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|GP-II(TM) (POROFOCON B) CONTACT LENS|HPX|OP|||N|01/21/1982|03/25/1982|||APPR|
N18032|S005|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|CABCURVE (POROFOCAN B)|HPX|OP|||N|08/25/1982|02/10/1983|||APPR|
N18032|S006|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|CABCURVE (POROFOCAN B)|HPX|OP|||N|04/05/1983|10/25/1983|||APPR|
N18033|S001|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|08/28/1979|10/01/1979|||APPR|
N18033|S003|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO-MARC (ETALFILCON A) CONTACT LENES|LPL|OP|||N|03/05/1981|07/10/1981|||APPR|
N18033|S004|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|VISTAMARC(TM) CONTACT LENS|LPL|OP|||N|04/08/1982|11/02/1982|||APPR|
N18033|S005|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|07/07/1982|09/09/1982|||APPR|
N18033|S006|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|12/27/1982|08/10/1984||09/17/1984|APPR|
N18033|S007|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|03/24/1983|11/07/1983|||APPR|
N18033|S008|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|07/15/1983|03/19/1984|||APPR|
N18033|S009|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|12/21/1983|03/29/1984|||APPR|
N18033|S010|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|12/10/1984|06/25/1985|||APPR|
N18033|S011|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|02/25/1985|10/04/1985|||APPR|
N18033|S013|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|09/11/1985|12/15/1986|||APPR|
N18033|S014|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|HYDRO MARC LENSES (HYDROPHILIC)|LPL|OP|||N|03/26/1986|10/15/1986|||APPR|
N18033|S015|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|VISTAMARC TORIC (ETAFILCON A)|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1986|02/26/1988|||APPR|
N18033|S016|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|VISTAMARC TORIC (ETAFILCON A)|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/18/1987|07/14/1987|||APPR|
N18033|S017|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|ISTAMARC TORIC (ETAFILCONA))|LPL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/1987|10/05/1987|||APPR|
N18033|S018|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|ISTAMARC TORIC (ETAFILCONA))|LPL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/1987|11/25/1987|||APPR|
N18033|S019|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|ISTAMARC TORIC (ETAFILCONA))|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1988|09/14/1988|||APPR|
N18033|S020|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|ISTAMARC TORIC (ETAFILCONA))|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|12/28/1989|||APPR|
N18033|S021|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|ISTAMARC TORIC (ETAFILCONA))|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|10/23/1989|||APPR|
N18033|S022|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|ISTAMARC TORIC (ETAFILCONA))|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|12/29/1989|||APPR|
N18033|S024|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|ACUVUE(R) (ETAFILICON A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/05/1990|10/27/1993|||APPR|
N18033|S025|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|VISTAKON  (ETAFILICON A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Other Report|N|09/21/1990|01/24/1991|||APPR|
N18033|S026|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|VISTAKON  (ETAFILICON A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/1992|11/04/1993|||APPR|
N18033|S027|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, daily wear|VISTAKON  (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/1993|02/13/1995|||APPR|
N18073|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE|LPN|OP|||N|06/23/1979|08/09/1979|||APPR|
N18073|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOL.|LPN|OP|||N|02/05/1980|08/07/1980|||APPR|
N18073|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOL.|LPN|OP|||N|04/13/1982|02/17/1983|||APPR|
N18073|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOL.|LPN|OP|||N|06/07/1983|10/03/1983|||APPR|
N18073|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOL.|LPN|OP|||N|04/08/1985|12/31/1985|||APPR|
N18073|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOL.|LPN|OP|||N|08/12/1985|01/06/1986|||APPR|
N18073|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOL.|LPN|OP|||N|08/12/1985|12/31/1985|||APPR|
N18073|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Other Report|N|06/11/1986|10/27/1986|||APPR|
N18073|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/02/1986|12/15/1986|||APPR|
N18073|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1986|01/09/1987|||APPR|
N18073|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1986|12/22/1986|||APPR|
N18073|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|THIRTY DAY TRACK|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/1986|12/04/1986|||APPR|
N18073|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/1987|03/09/1987|||APPR|
N18073|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/30/1987|07/27/1988|||APPR|
N18073|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/1989|11/21/1989|||APPR|
N18073|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1990|06/05/1990|||APPR|
N18073|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/1990|05/28/1991|||APPR|
N18073|S022|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1990|04/13/1994|||APPR|
N18073|S023|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/1992|05/18/1993|||APPR|
N18078|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM|LPN|OP|||N|07/31/1979|07/27/1981|||APPR|
N18078|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|08/09/1979|03/24/1980|||APPR|
N18078|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|07/24/1980|12/11/1980|||APPR|
N18078|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|04/06/1981|12/10/1981|||APPR|
N18078|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE THERMAL|LPN|OP|||N|04/13/1981|12/10/1981|||APPR|
N18078|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|04/13/1982|02/17/1983|||APPR|
N18078|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE THERMAL PRESERVED SALINE SOLUTION|LPN|OP|||N|06/17/1982|02/17/1983|||APPR|
N18078|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|PRESERVATIVE-FREE SOFT LENS RINSE|LPN|OP|||N|04/28/1983|08/04/1983|||APPR|
N18078|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|05/16/1983|10/03/1983|||APPR|
N18078|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) LENS DROPS|LPN|OP|||N|01/04/1984|12/13/1984|||APPR|
N18078|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|05/03/1984|10/22/1985|||APPR|
N18078|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|08/27/1984|02/20/1986|||APPR|
N18078|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|01/02/1985|01/06/1986|||APPR|
N18078|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|01/23/1985|12/31/1985|||APPR|
N18078|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|04/08/1985|12/31/1985|||APPR|
N18078|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|07/05/1985|12/20/1985|||APPR|
N18078|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|07/23/1985|01/06/1986|||APPR|
N18078|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|04/09/1985|01/10/1986|||APPR|
N18078|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|12/13/1985|11/12/1986|||APPR|
N18078|S021|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|01/21/1986|04/14/1986|||APPR|
N18078|S022|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|03/13/1986|10/03/1986|||APPR|
N18078|S023|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|||N|03/24/1986|05/28/1986|||APPR|
N18078|S024|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/1986|07/01/1986|||APPR|
N18078|S025|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/1986|07/07/1986|||APPR|
N18078|S026|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/1986|10/14/1986|||APPR|
N18078|S027|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/1986|10/15/1986|||APPR|
N18078|S028|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/1986|12/31/1986|||APPR|
N18078|S029|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|THIRTY DAY TRACK|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/1986|12/04/1986|||APPR|
N18078|S030|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/1987|03/26/1987|||APPR|
N18078|S031|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/1987|07/01/1987|||APPR|
N18078|S032|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/1987|07/23/1987|||APPR|
N18078|S033|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/1987|12/01/1987|||APPR|
N18078|S034|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/1987|04/04/1988|||APPR|
N18078|S035|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/1987|03/15/1988|||APPR|
N18078|S036|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/30/1987|07/27/1988|||APPR|
N18078|S037|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/30/1987|07/27/1988|||APPR|
N18078|S038|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/1988|05/10/1988|||APPR|
N18078|S039|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/1988|08/11/1988|||APPR|
N18078|S040|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/1988|10/28/1988|||APPR|
N18078|S041|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1989|02/01/1990|||APPR|
N18078|S042|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1989|09/14/1989|||APPR|
N18078|S043|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/1989|11/03/1989|||APPR|
N18078|S044|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/1989|11/14/1989|||APPR|
N18078|S045|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTHERM SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/1990|05/28/1991|||APPR|
N18078|S047|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOL.|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1990|04/13/1994|||APPR|
N18078|S048|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SALINE SOLUTION FOR SENSITIVE EYES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/1992|05/18/1993|||APPR|
N18114|S003|RYNCO SCIENTIFIC CORP.|2 SOUTH TYSON AVENUEK|P.O. BOX 270|FLORAL PARK|NY|10001||Lens, contact (polymethylmethacrylate)|RX-56 POROFOCON A CONTACT LENS|HPX|OP|||N|08/19/1980|03/16/1981|||APPR|
N18114|S004|RYNCO SCIENTIFIC CORP.|2 SOUTH TYSON AVENUEK|P.O. BOX 270|FLORAL PARK|NY|10001||Lens, contact (polymethylmethacrylate)|RX-56 POROFOCON A CONTACT LENS|HPX|OP|||N|08/19/1980|03/16/1981|||APPR|
N18114|S005|RYNCO SCIENTIFIC CORP.|2 SOUTH TYSON AVENUEK|P.O. BOX 270|FLORAL PARK|NY|10001||Lens, contact (polymethylmethacrylate)|RX-56 SEMI-RIGID GAS PERMEABLE CONTACT LENS|HPX|OP|||N|02/03/1981|06/30/1982|||APPR|
N18114|S007|RYNCO SCIENTIFIC CORP.|2 SOUTH TYSON AVENUEK|P.O. BOX 270|FLORAL PARK|NY|10001||Lens, contact (polymethylmethacrylate)|RX-56 POROFOCON A CONTACT LENS|HPX|OP|||N|09/01/1982|09/24/1982|||APPR|
N18120|S002|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON HARD CONTACT LENSE|HPX|OP|||N|03/08/1981|03/08/1981|||APPR|
N18120|S003|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|05/14/1979|09/13/1979|||APPR|
N18120|S005|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|06/26/1980|04/19/1982|||APPR|
N18120|S006|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|07/28/1980|07/10/1981|||APPR|
N18120|S007|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|08/01/1980|12/10/1980|||APPR|
N18120|S008|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|05/28/1981|07/15/1982||09/21/1982|APPR|
N18120|S009|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|02/23/1982|05/14/1982|||APPR|
N18120|S010|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|07/06/1982|08/06/1982|||APPR|
N18120|S011|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|11/26/1982|02/02/1983|||APPR|
N18120|S012|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|03/30/1983|06/30/1983|||APPR|
N18120|S013|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|04/27/1984|11/19/1984|||APPR|
N18120|S014|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|05/01/1984|04/30/1985|||APPR|
N18120|S015|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|11/13/1984|12/12/1985||02/10/1986|APPR|
N18120|S016|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|||N|02/15/1985|05/03/1985|||APPR|
N18120|S017|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|Normal 180 Day Track|Other Report|N|05/18/1987|04/28/1988|||APPR|
N18120|S018|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|05/26/1987|06/16/1987|||APPR|
N18120|S019|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/1987|05/10/1988|||APPR|
N18120|S021|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/1988|11/15/1988|||APPR|
N18120|S022|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/27/1988|12/21/1988|89M-0002|03/07/1989|APPR|
N18120|S023|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/23/1990|||APPR|
N18120|S024|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON CONTACT LENS|HPX|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/1989|09/06/1991|||APPR|
N18120|S025|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON (SILAFOCON A) CONTACT LENSES|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/1990|07/10/1990|||APPR|
N18120|S026|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON (SILAFOCON A) CONTACT LENSES|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/1990|07/12/1990|||APPR|
N18120|S027|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|POLYCON (SILAFOCON A) CONTACT LENSES|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/1990|06/24/1991|||APPR|
N18143|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEX CARE SOLUTIONS|LPN|OP|||N|01/01/1900|05/22/1979|||APPR|
N18143|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEX CARE SOLUTIONS|LPN|OP|||N|06/04/1979|08/19/1980|||APPR|
N18143|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEX CARE SOLUTIONS|LPN|OP|||N|07/02/1979|07/11/1979|||APPR|
N18143|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEX CARE SOLUTIONS|LPN|OP|||N|07/05/1979|08/01/1979|||APPR|
N18143|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEX CARE SOLUTIONS|LPN|OP|||N|07/24/1979|08/17/1979|||APPR|
N18143|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEX CARE SOLUTIONS|LPN|OP|||N|08/29/1979|01/30/1980|||APPR|
N18143|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEX CARE SOLUTIONS|LPN|OP|||N|08/29/1979|11/02/1979|||APPR|
N18143|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEX CARE SOLUTIONS|LPN|OP|||N|09/06/1979|10/12/1979|||APPR|
N18143|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|11/28/1979|01/30/1980|||APPR|
N18143|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|04/07/1980|03/15/1982|||APPR|
N18143|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|04/25/1980|06/19/1980|||APPR|
N18143|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|05/05/1980|11/14/1980|||APPR|
N18143|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|05/06/1980|11/12/1980|||APPR|
N18143|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|Special (Immediate Track)||N|05/12/1980|05/12/1980|||APPR|
N18143|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|06/19/1980|12/11/1980|||APPR|
N18143|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|09/02/1980|02/27/1981|||APPR|
N18143|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|09/16/1980|03/02/1981|||APPR|
N18143|S018|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEX-CARE|LPN|OP|||N|03/05/1981|09/30/1981|||APPR|
N18143|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|04/01/1983|08/24/1983|||APPR|
N18143|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|11/13/1981|03/15/1982|||APPR|
N18143|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|03/23/1982|04/26/1982|||APPR|
N18143|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|11/26/1982|03/15/1984|||APPR|
N18143|S024|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|12/08/1983|11/02/1984|||APPR|
N18143|S025|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|12/14/1983|06/29/1984|||APPR|
N18143|S027|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|06/08/1984|05/20/1985|||APPR|
N18143|S028|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX AND FLEXCARE SOL.|LPN|OP|||N|07/18/1984|06/10/1985|||APPR|
N18143|S029|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEX-CARE II|LPN|OP|||N|12/31/1984|08/27/1986|||APPR|
N18143|S031|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEX-CARE II|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/21/1989|06/04/1990|||APPR|
N18143|S032|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEX-CARE II|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
N18146|S001|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, daily wear|SOFFORM CONTACT LENS|LPL|OP|||N|04/24/1979|05/25/1979|||APPR|
N18146|S002|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, daily wear|SOF FORM CONTACT LENSE|LPL|OP|||N|05/01/1979|05/08/1980|||APPR|
N18146|S003|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, daily wear|SOF FORM (DELTAFILCON A)|LPL|OP|||N|02/29/1980|02/29/1980|||APPR|
N18146|S005|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, daily wear|SOF FORM (DELTAFILCON A)|LPL|OP|||N|06/11/1980|07/10/1981|||APPR|
N18146|S006|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, daily wear|SOF FORM (DELTAFILCON A)|LPL|OP|||N|11/17/1980|11/27/1981|||APPR|
N18146|S007|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, daily wear|SOF FORM (DELTAFILCON A)|LPL|OP|||N|07/21/1981|11/27/1981|||APPR|
N18162|S001|AQUARIUS SOFT LENS, INC.|1718 LAFAYETTE RD.||INDIANAPOLIS|IN|46222||Lenses, soft contact, daily wear|TRI POL|LPL|OP|||N|05/21/1979|06/07/1979|||APPR|
N18162|S002|AQUARIUS SOFT LENS, INC.|1718 LAFAYETTE RD.||INDIANAPOLIS|IN|46222||Lenses, soft contact, daily wear|AQUA-SOFT (DELTAFILC|LPL|OP|||N|06/27/1979|08/31/1979|||APPR|
N18162|S003|AQUARIUS SOFT LENS, INC.|1718 LAFAYETTE RD.||INDIANAPOLIS|IN|46222||Lenses, soft contact, daily wear|AQUA SOFT CONTACT LENS|LPL|OP|||N|08/31/1982|10/21/1982|||APPR|
N18175|S001|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|04/02/1980|05/02/1980|||APPR|
N18175|S002|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|09/12/1980|12/17/1980|||APPR|
N18175|S003|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|11/13/1980|12/31/1980|||APPR|
N18175|S004|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL (POLYGLACTIN 910) SUTURE (DYED)|GAK|SU|||N|12/04/1980|07/07/1981|||APPR|
N18175|S005|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|CPATED VICRYL (POLYGLACTIN 910) ABSORBABLE|GAK|SU|||N|02/11/1981|06/11/1981|||APPR|
N18175|S006|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|05/11/1981|09/24/1981|||APPR|
N18175|S007|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|05/19/1981|08/11/1981|||APPR|
N18175|S008|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|08/04/1981|09/21/1981|||APPR|
N18175|S009|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|05/13/1982|07/09/1982|||APPR|
N18175|S010|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|03/04/1982|07/21/1982|||APPR|
N18175|S012|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|12/20/1982|05/02/1984|||APPR|
N18175|S013|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|||N|05/05/1983|03/27/1984|||APPR|
N18175|S015|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA|GAK|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N18176|S001|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|04/02/1980|05/02/1980|||APPR|
N18176|S002|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|09/12/1980|12/17/1980|||APPR|
N18176|S003|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|11/13/1980|12/31/1980|||APPR|
N18176|S004|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL (POLYGLACTIN 910)|GAK|SU|||N|12/04/1980|07/07/1981|||APPR|
N18176|S005|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|02/11/1981|06/11/1981|||APPR|
N18176|S006|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|05/11/1981|09/24/1981|||APPR|
N18176|S007|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|05/19/1981|08/11/1981|||APPR|
N18176|S008|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|08/04/1981|09/21/1981|||APPR|
N18176|S009|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|03/04/1982|07/21/1982|||APPR|
N18176|S011|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|12/20/1982|05/02/1984|||APPR|
N18176|S012|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|||N|05/05/1983|03/27/1984|||APPR|
N18176|S014|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N18176|S015|ETHICON, INC.|P.O. BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876|0151|SUTURE, ABSORBABLE|COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED)|GAK|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N18180|S001|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|TRIPOL 43|LPL|OP|||N|05/21/1979|06/07/1979|||APPR|
N18180|S003|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|CUSTOMFLEX (DELTAFILCON A) HYDROPHILIC CONTACT LEN|LPL|OP|||N|01/19/1981|05/11/1981|||APPR|
N18180|S004|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|CUSTOMFLEX CONTACT LENS|LPL|OP|||N|02/13/1981|05/22/1981|||APPR|
N18180|S006|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|CUSTOMFLEX CONTACT LENS|LPL|OP|||N|10/23/1981|02/05/1982|||APPR|
N18286|S003|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/23/1989|07/24/1989|||APPR|
N18286|S004|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/1989|05/23/1990|||APPR|
N18286|S005|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1991|04/30/1992|||APPR|
N18286|S006|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/24/1991|07/21/1992|||APPR|
N18286|S007|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1992|09/10/1992|||APPR|
N18331|S001|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|12/28/1981|01/28/1982|||APPR|
N18331|S002|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|01/15/1982|04/05/1982|||APPR|
N18331|S003|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|01/15/1982|04/05/1982|||APPR|
N18331|S004|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|01/25/1982|05/21/1982|||APPR|
N18331|S005|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|02/25/1982|03/15/1982|||APPR|
N18331|S006|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|02/25/1982|07/14/1982|||APPR|
N18331|S007|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|03/04/1982|07/21/1982|||APPR|
N18331|S008|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|10/18/1982|12/22/1982|||APPR|
N18331|S009|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|12/20/1982|05/02/1984|||APPR|
N18331|S010|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|02/24/1983|04/04/1983|||APPR|
N18331|S011|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|03/04/1983|04/18/1983|||APPR|
N18331|S012|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|03/17/1983|09/06/1984|||APPR|
N18331|S013|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|05/05/1983|03/27/1984|||APPR|
N18331|S014|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|08/08/1983|11/23/1983|||APPR|
N18331|S015|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|12/08/1983|06/05/1984|||APPR|
N18331|S016|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|||N|03/08/1985|06/06/1986|86M-0270|07/22/1986|APPR|
N18331|S017|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N18331|S018|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N18331|S019|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/1987|08/28/1987|||APPR|
N18331|S020|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/1987|10/05/1987|||APPR|
N18331|S021|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS SUTURE (DYED)|NEW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/1989|05/17/1989|||APPR|
N18331|S022|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED|NEW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/1990|03/20/1990|||APPR|
N18331|S023|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED|NEW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/1993|12/09/1993|||APPR|
N18331|S024|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED|NEW|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/1994|12/21/1994|||APPR|
N18387|S001|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|01/15/1982|04/05/1982|||APPR|
N18387|S002|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|01/15/1982|04/05/1982|||APPR|
N18387|S003|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|01/25/1982|05/21/1982|||APPR|
N18387|S004|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|02/25/1982|03/15/1982|||APPR|
N18387|S005|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|02/25/1982|07/14/1982|||APPR|
N18387|S006|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|03/04/1982|07/21/1982|||APPR|
N18387|S007|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|12/20/1982|05/02/1984|||APPR|
N18387|S008|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|04/18/1983|06/07/1983|||APPR|
N18387|S009|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|05/05/1983|03/27/1984|||APPR|
N18387|S010|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|||N|08/08/1983|11/23/1983|||APPR|
N18387|S011|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N18387|S012|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|PDS(TM) SUTURE (CLEAR)|GAM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1987|06/18/1987|||APPR|
N18466|S001|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|||N|08/06/1984|08/28/1984|||APPR|
N18466|S002|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|||N|11/08/1984|06/04/1985|||APPR|
N18466|S003|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|||N|02/22/1985|04/24/1985|||APPR|
N18466|S004|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|||N|02/20/1986|05/23/1986|||APPR|
N18466|S005|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/1986|08/01/1986|||APPR|
N18466|S006|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/1988|01/19/1989|||APPR|
N18466|S007|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1988|05/19/1989|||APPR|
N18466|S008|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1988|01/13/1989|||APPR|
N18466|S009|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/22/1989|06/08/1990|||APPR|
N18466|S011|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW(TM) RADIOPAQUE BONE CEMENT, HALF PACK|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1990|06/04/1991|||APPR|
N18466|S012|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW(TM)2 QUICK SETTING BONE CEMENT|LOD|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/14/1991|07/02/1991|||APPR|
N18466|S013|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|ACRYLOC BONE CEMENT|LOD|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/03/1991|07/02/1991|||APPR|
N18466|S014|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|PROSFIX(TM) BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/1991|02/19/1993|||APPR|
N18466|S015|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW ORTHOPAEDIC BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/1993|02/15/1994|||APPR|
N18466|S016|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW ORTHOPEDIC  BONE CEMENT|LOD|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/08/1994|06/21/1995|||APPR|
N50485|S001|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|10/22/1979|04/11/1980|||APPR|
N50485|S002|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIBACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|10/29/1979|08/14/1980|||APPR|
N50485|S003|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|08/12/1980|01/15/1981|||APPR|
N50485|S005|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|12/01/1981|08/06/1982|||APPR|
N50485|S006|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|07/26/1983|03/15/1984|||APPR|
N50485|S007|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|09/13/1983|03/15/1984|||APPR|
N50485|S009|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|12/08/1983|06/08/1984|||APPR|
N50485|S010|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|01/05/1984|03/26/1985|||APPR|
N50485|S011|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|03/02/1984|04/10/1984|||APPR|
N50485|S012|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|Normal 180 Day Track||N|04/23/1984|07/20/1984|||APPR|
N50485|S013|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|Normal 180 Day Track||N|04/23/1984|07/20/1984|||APPR|
N50485|S014|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|||N|08/16/1984|08/22/1985|||APPR|
N50485|S015|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/1987|08/10/1987|||APPR|
N50485|S016|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|Normal 180 Day Track|Other Report|N|06/12/1987|08/10/1987|||APPR|
N50485|S017|ORGANON TEKNIKA CORP.|800 CAPITOLA DR.||DURHAM|NC|27713||DISCS, ELUTION|AMIKACIN ELUTION DISK FOR AUTOBAC|LTX|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1987|04/05/1988|||APPR|
N50487|S001|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|12/27/1978|04/10/1979|||APPR|
N50487|S003|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|10/02/1979|04/11/1980|||APPR|
N50487|S004|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|04/14/1980|10/14/1980|||APPR|
N50487|S005|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|08/04/1980|10/17/1980|||APPR|
N50487|S006|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|12/12/1980|05/06/1981|||APPR|
N50487|S007|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|UTI MIC TEST PANEL|LON|MI|||N|12/16/1980|05/06/1981|||APPR|
N50487|S008|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|12/16/1980|05/06/1981|||APPR|
N50487|S009|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|03/23/1981|04/30/1981|||APPR|
N50487|S010|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|08/13/1981|09/22/1981|||APPR|
N50487|S011|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|04/22/1982|11/16/1982|||APPR|
N50487|S012|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|05/19/1982|11/16/1982|||APPR|
N50487|S013|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|06/29/1982|10/08/1982|||APPR|
N50487|S015|MICROTECH MEDICAL SYSTEMS, INC.|13930 RIVER RD.||POTOMIC|MD|20854||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST PANELS|LON|MI|||N|07/13/1983|03/01/1984|||APPR|
N50494|S003|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|10/24/1980|03/03/1981|||APPR|
N50494|S004|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|12/07/1981|03/12/1982|||APPR|
N50494|S005|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|02/16/1982|06/30/1982|||APPR|
N50494|S006|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|05/04/1982|11/02/1983|||APPR|
N50494|S007|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|07/26/1982|09/03/1982|||APPR|
N50494|S008|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|10/18/1982|12/22/1982|||APPR|
N50494|S009|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|11/03/1982|12/01/1982|||APPR|
N50494|S010|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|04/04/1983|07/08/1983|||APPR|
N50494|S011|PASCO LABORATORIES, INC.|12750 WEST 42ND AVE.||WHEAT RIDGE|CO|80033||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC ANTIBIOTIC TEST PANELS|LTT|MI|||N|04/05/1983|07/25/1983|||APPR|
N50510|S001|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|E COLI EXTENSION|LTW|MI|||N|04/24/1979|08/01/1979|||APPR|
N50510|S002|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|E COLI STORAGE CONDITION|LTW|MI|||N|05/02/1979|08/01/1979|||APPR|
N50510|S005|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|03/28/1980|06/16/1980|||APPR|
N50510|S006|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|01/28/1982|07/26/1982|||APPR|
N50510|S007|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|06/14/1984|02/19/1985|||APPR|
N50510|S008|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|06/25/1984|02/19/1985|||APPR|
N50510|S009|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|07/02/1984|02/19/1985|||APPR|
N50510|S010|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|07/16/1984|02/19/1985|||APPR|
N50510|S011|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|07/30/1984|02/19/1985|||APPR|
N50510|S012|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|08/13/1984|02/19/1985|||APPR|
N50510|S013|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|10/22/1984|02/19/1985|||APPR|
N50510|S014|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|11/01/1984|02/19/1985|||APPR|
N50510|S015|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|11/01/1984|03/01/1985|||APPR|
N50510|S017|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|12/04/1984|02/19/1985|||APPR|
N50510|S018|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|12/26/1984|03/01/1985|||APPR|
N50510|S019|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|02/15/1985|06/04/1985|||APPR|
N50510|S020|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|08/30/1985|12/20/1985|||APPR|
N50510|S021|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|10/21/1985|02/11/1986|||APPR|
N50510|S022|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|12/05/1985|02/28/1986|||APPR|
N50510|S023|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|02/19/1986|03/27/1986|||APPR|
N50510|S024|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMMENDMENT TO E. COLI ASC|LTW|MI|||N|03/28/1986|05/21/1986|||APPR|
N50510|S025|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS CEFOTETAN CARD|LTW|MI|Normal 180 Day Track|Other Report|N|07/29/1986|09/29/1986|||APPR|
N50510|S026|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS CEFOTETAN CARD|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/1987|07/16/1987|||APPR|
N50510|S027|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/1987|07/16/1987|||APPR|
N50510|S028|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/1987|07/20/1987|||APPR|
N50510|S029|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/08/1987|11/17/1987|||APPR|
N50510|S030|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1987|12/17/1987|||APPR|
N50510|S031|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/1987|01/13/1988|||APPR|
N50510|S032|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1988|08/10/1988|||APPR|
N50510|S033|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1988|08/10/1988|||APPR|
N50510|S034|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Other Report|N|07/12/1988|08/22/1988|||APPR|
N50510|S035|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1988|09/07/1988|||APPR|
N50510|S036|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Other Report|N|08/15/1988|09/26/1988|||APPR|
N50510|S037|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Other Report|N|08/31/1988|10/24/1988|||APPR|
N50510|S038|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/1988|11/01/1988|||APPR|
N50510|S039|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1988|12/22/1988|||APPR|
N50510|S040|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1988|04/12/1989|||APPR|
N50510|S041|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/06/1989|03/08/1990|||APPR|
N50510|S042|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK MINOCYCLINE CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1990|08/03/1990|||APPR|
N50510|S043|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK IMIPENUM CARD|LTW|MI|Normal 180 Day Track|Other Report|N|06/05/1990|10/22/1990|||APPR|
N50510|S044|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) AMPICILLIN/SULBACTAM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/22/1990|10/04/1990|||APPR|
N50510|S045|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/1990|09/24/1990|||APPR|
N50510|S046|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1991|06/22/1992|||APPR|
N50510|S051|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/25/1992|11/19/1992|||APPR|
N50510|S052|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1992|06/24/1993|||APPR|
N50510|S057|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/09/1993|02/23/1995|||APPR|
N50510|S058|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/1993|06/17/1994|||APPR|
N50510|S059|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1993|08/30/1994|||APPR|
N50510|S061|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/1994|03/01/1995|||APPR|
N50510|S063|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK LOMEFLOXACIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1994|11/16/1995|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIMICROBIAL LOMOFLOXACIN OT THE VITEK GRAM NEGATIVE ANTIMICROBIAL PANELS
N50510|S064|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK PIPERACILLIN/TAZOBACTAM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1994|11/27/1995|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIMICROBIAL PIPERACILLIN/TAZOBACTAM TO THE VITEK GRAM NEGATIVE ANTIMICROBIAL PANELS
N50510|S065|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/1994|12/14/1994|||APPR|
N50510|S066|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|||N|10/04/1994|11/03/1994|||APPR|
N50524|S001|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|09/10/1979|09/21/1979|||APPR|
N50524|S002|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|06/21/1979|01/14/1980|||APPR|
N50524|S003|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST SYSTEM|LON|MI|||N|01/14/1980|02/15/1980|||APPR|
N50524|S004|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MIC TEST SYSTEM|LON|MI|||N|01/14/1980|02/15/1980|||APPR|
N50524|S005|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|03/17/1980|04/25/1980|||APPR|
N50524|S006|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|03/17/1980|04/22/1980|||APPR|
N50524|S007|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|09/29/1980|03/16/1981|||APPR|
N50524|S008|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|11/10/1980|04/14/1981|||APPR|
N50524|S009|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|12/01/1981|08/06/1982|||APPR|
N50524|S010|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|01/12/1982|03/01/1983|||APPR|
N50524|S011|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|03/12/1982|04/19/1982|||APPR|
N50524|S012|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|02/15/1983|07/18/1983|||APPR|
N50524|S013|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|07/12/1983|02/15/1984|||APPR|
N50524|S014|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|09/13/1983|10/18/1983|||APPR|
N50524|S016|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|11/30/1983|11/27/1985|||APPR|
N50524|S018|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|01/05/1984|11/21/1985|||APPR|
N50524|S019|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|03/28/1984|09/13/1984|||APPR|
N50524|S020|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|||N|10/15/1985|03/17/1986|||APPR|
N50524|S021|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1987|04/05/1988|||APPR|
N50524|S022|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/1988|04/12/1988|||APPR|
N50524|S023|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/1988|04/20/1988|||APPR|
N50524|S024|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1988|07/20/1988|||APPR|
N50524|S025|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/1988|07/07/1988|||APPR|
N50524|S026|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/11/1988|06/22/1988|||APPR|
N50524|S027|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/1988|07/21/1988|||APPR|
N50524|S028|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1988|08/22/1988|||APPR|
N50524|S029|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1988|09/26/1988|||APPR|
N50524|S030|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1988|10/18/1988|||APPR|
N50524|S031|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1988|12/28/1988|||APPR|
N50524|S032|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/1989|06/13/1989|||APPR|
N50524|S033|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1989|01/22/1990|||APPR|
N50524|S035|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MIC TEST SYSTEM|LON|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/04/1989|12/07/1989|||APPR|
N50525|S001|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MS 2 MICROBIAL SYSTEM|LON|MI|||N|07/16/1979|01/10/1980|||APPR|
N50525|S002|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|05/12/1981|10/13/1981|||APPR|
N50525|S003|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|11/05/1981|02/05/1982|||APPR|
N50525|S004|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|12/18/1981|03/11/1982|||APPR|
N50525|S005|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|08/16/1982|12/27/1982|||APPR|
N50525|S006|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|10/26/1982|03/15/1983|||APPR|
N50525|S007|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|05/05/1983|10/06/1983|||APPR|
N50525|S008|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|10/12/1983|01/04/1984|||APPR|
N50525|S009|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|08/10/1984|05/14/1985|||APPR|
N50525|S010|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|||N|11/20/1984|10/08/1985|||APPR|
N50525|S011|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Other Report|N|08/12/1986|04/16/1987|||APPR|
N50525|S012|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Other Report|N|09/05/1986|04/16/1987|||APPR|
N50525|S013|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/23/1987|07/16/1987|||APPR|
N50525|S014|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Special (Immediate Track)|Other Report|N|04/23/1987|07/16/1987|||APPR|
N50525|S015|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/27/1987|01/11/1988|||APPR|
N50525|S016|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1987|01/11/1988|||APPR|
N50525|S017|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Special (Immediate Track)|Other Report|N|03/11/1988|04/20/1988|||APPR|
N50525|S018|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/11/1988|04/20/1988|||APPR|
N50525|S019|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/1988|06/08/1988|||APPR|
N50525|S020|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/09/1988|11/10/1988|||APPR|
N50525|S021|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/10/1989|03/10/1989|||APPR|
N50525|S022|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/10/1989|03/09/1989|||APPR|
N50525|S023|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/13/1989|11/16/1989|||APPR|
N50525|S024|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/1989|09/25/1989|||APPR|
N50525|S025|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/07/1989|12/19/1989|||APPR|
N50525|S026|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA  AP6C-2|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/1990|05/04/1990|||APPR|
N50531|S003|TREK DIAGNOSTIC SYSTEMS, INC.|210 BUSINESS PARK DR.||SUN PRAIRIE|WI|53590||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|SENSITITRE|LON|MI|||N|05/19/1980|08/13/1980|||APPR|
N50531|S004|TREK DIAGNOSTIC SYSTEMS, INC.|210 BUSINESS PARK DR.||SUN PRAIRIE|WI|53590||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|SENSITITRE|LON|MI|||N|01/30/1981|04/14/1981|||APPR|
N50531|S005|TREK DIAGNOSTIC SYSTEMS, INC.|210 BUSINESS PARK DR.||SUN PRAIRIE|WI|53590||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|SENSITITRE|LON|MI|||N|11/02/1981|04/08/1982|||APPR|
N50531|S006|TREK DIAGNOSTIC SYSTEMS, INC.|210 BUSINESS PARK DR.||SUN PRAIRIE|WI|53590||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|SENSITITRE|LON|MI|||N|10/20/1982|02/17/1983|||APPR|
N50531|S007|TREK DIAGNOSTIC SYSTEMS, INC.|210 BUSINESS PARK DR.||SUN PRAIRIE|WI|53590||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|SENSITITRE|LON|MI|||N|10/17/1983|03/07/1984|||APPR|
N50538|S001|FLOW LABORATORIES, INC.|7655 OLD SPRINGHOUSE RD.||MCLEAN|VA|22102||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|3M BRAND MICROBIAL PROFILE SYSTEM|LON|MI|||N|03/02/1981|04/17/1981|||APPR|
N5798|S001|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Agent, absorbable hemostatic, non-collagen based|OXYCEL|LMG|SU|||N|10/27/1980|12/17/1980|||APPR|
N5798|S002|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Agent, absorbable hemostatic, non-collagen based|OXYCEL|LMG|SU|||N|10/29/1980|12/17/1980|||APPR|
N5798|S003|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Agent, absorbable hemostatic, non-collagen based|OXYCEL|LMG|SU|||N|06/29/1982|12/17/1982|||APPR|
N5798|S004|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Agent, absorbable hemostatic, non-collagen based|OXYCEL|LMG|SU|||N|04/21/1983|06/03/1983|||APPR|
N5798|S005|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Agent, absorbable hemostatic, non-collagen based|OXYCEL   OXIDIZED|LMG|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/1988|02/08/1991|||APPR|
N5798|S006|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Agent, absorbable hemostatic, non-collagen based|OXYCELL|LMG|SU|Normal 180 Day Track|Other Report|N|12/19/1990|02/08/1991|||APPR|
N62160|S001|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|12/26/1979|04/11/1980|||APPR|
N62160|S004|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|07/31/1980|02/10/1981|||APPR|
N62160|S005|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|02/23/1981|05/11/1981|||APPR|
N62160|S006|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|06/21/1982|11/18/1982|||APPR|
N62160|S007|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|12/22/1982|02/03/1983|||APPR|
N62160|S008|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|04/07/1983|08/10/1983|||APPR|
N62160|S009|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|05/17/1983|09/28/1983|||APPR|
N62160|S010|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|09/19/1983|10/12/1983|||APPR|
N62160|S011|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|10/27/1983|01/30/1984|||APPR|
N62160|S012|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|11/02/1983|01/30/1984|||APPR|
N62160|S013|AMERICAN MICRO SCAN|1580 DELL AVE.||CAMPBELL|CA|95008||PANELS, TEST, SUSCEPTIBILITY, ANTIMICROBIAL|MIC PANELS|LTT|MI|||N|06/12/1984|03/05/1985|||APPR|
N6264|S003|JOHNSON & JOHNSON MEDICAL, INC.|1 JOHNSON & JOHNSON PLAZA||NEW BRUNSWICK|NJ|08933||POWDER, DUSTING, SURGICAL|BIO-SORB ABSORBABLE DUSTING POWDER|KGP|HO|||N|08/21/1985|09/10/1985|||APPR|
N80535|S001|INGREDION INCORPORATED|10 FINDERNE AVENUE|SUITE C|BRIDGEWATER|NJ|08807||POWDER, DUSTING, SURGICAL|HALLMARK ABSORBO ABSORBABLE DUSTING POWDER|KGP|HO|Normal 180 Day Track|Other Report|N|03/02/1973|03/02/1973|||APPR|
N80535|S002|INGREDION INCORPORATED|10 FINDERNE AVENUE|SUITE C|BRIDGEWATER|NJ|08807||POWDER, DUSTING, SURGICAL|HALLMARK ABSORBO ABSORBABLE DUSTING POWDER|KGP|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/02/1973|03/02/1973|||APPR|
N80535|S003|INGREDION INCORPORATED|10 FINDERNE AVENUE|SUITE C|BRIDGEWATER|NJ|08807||POWDER, DUSTING, SURGICAL|ENTER CORRECT TRADE NAME|KGP|HO|Normal 180 Day Track|Other Report|N|03/02/1973|03/02/1973|||APPR|
N80535|S004|INGREDION INCORPORATED|10 FINDERNE AVENUE|SUITE C|BRIDGEWATER|NJ|08807||POWDER, DUSTING, SURGICAL|HALLMARK ABSORBO ABSORBABLE DUSTING POWDER|KGP|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1974|03/12/1975|||APPR|
N80535|S005|INGREDION INCORPORATED|10 FINDERNE AVENUE|SUITE C|BRIDGEWATER|NJ|08807||POWDER, DUSTING, SURGICAL|HALLMARK ABSORBO ABSORBABLE DUSTING POWDER|KGP|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1989|12/13/1989|||APPR|
N80535|S006|INGREDION INCORPORATED|10 FINDERNE AVENUE|SUITE C|BRIDGEWATER|NJ|08807||POWDER, DUSTING, SURGICAL|HALLMARK ABSORBO ABSORBABLE DUSTING POWDER|KGP|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/1990|09/19/1990|||APPR|
N80838|S001|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|||N|11/02/1982|07/05/1983|||APPR|
N80838|S002|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|||N|11/02/1982|07/05/1983|||APPR|
N80838|S006|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|||N|03/07/1984|05/15/1984|||APPR|
N80838|S007|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|||N|11/13/1984|02/28/1985|||APPR|
N80838|S008|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|||N|03/27/1985|05/17/1985|||APPR|
N80838|S009|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|||N|06/05/1985|07/23/1985|||APPR|
N80838|S010|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1986|08/05/1986|||APPR|
N80838|S011|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|Normal 180 Day Track|Other Report|N|02/11/1987|06/29/1987|||APPR|
N80838|S012|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|Normal 180 Day Track|Other Report|N|07/21/1987|09/09/1987|||APPR|
N80838|S013|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/1988|08/31/1988|||APPR|
N80838|S014|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/27/1989|08/02/1989|||APPR|
N80838|S015|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/1989|06/08/1989|||APPR|
N80838|S016|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/20/1989|10/19/1989|||APPR|
N80838|S017|S. Jackson, Inc.|15 ROTH ST.|P.O. BOX 4487|ALEXANDRIA|VA|22303||Suture, nonabsorbable, synthetic, polyamide|SUPRAMID EXTRA SUTURES|GAR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1989|01/26/1990|||APPR|
N80950|S001|LOOK, INC.|2020 LONNIE ABBOTT INDUSTRIAL|BLVD. P.O.BOX 2087|ADA|OK|74820||Suture, nonabsorbable, synthetic, polyester|POLYVIOLENE SUTURE|GAS|SU|||N|07/10/1984|03/22/1985|||APPR|
N80950|S002|LOOK, INC.|2020 LONNIE ABBOTT INDUSTRIAL|BLVD. P.O.BOX 2087|ADA|OK|74820||Suture, nonabsorbable, synthetic, polyester|POLYVIOLENE SUTURE|GAS|SU|||N|01/28/1986|02/28/1986|||APPR|
N80950|S003|LOOK, INC.|2020 LONNIE ABBOTT INDUSTRIAL|BLVD. P.O.BOX 2087|ADA|OK|74820||Suture, nonabsorbable, synthetic, polyester|POLYVIOLENE SUTURE|GAS|SU|||N|03/21/1986|06/09/1986|||APPR|
N80989|S001|LUKENS CORP.|51 CHUBB WAY||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURES|GAP|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/1987|04/24/1987|||APPR|
N80989|S003|LUKENS CORP.|51 CHUBB WAY||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURES|GAP|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/1988|03/16/1988|||APPR|
N80989|S004|LUKENS CORP.|51 CHUBB WAY||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURES|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/1988|10/07/1988|||APPR|
N80989|S005|LUKENS CORP.|51 CHUBB WAY||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SILK|SILK SUTURES|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/1988|08/01/1989|||APPR|
N83038|S001|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|05/19/1981|09/01/1981|||APPR|
N83038|S011|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|08/18/1978|11/23/1981|||APPR|
N83038|S012|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|08/18/1978|11/23/1981|||APPR|
N83038|S013|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|08/18/1978|11/23/1981|||APPR|
N83038|S014|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|06/17/1982|07/16/1982|||APPR|
N83038|S015|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|06/17/1982|07/16/1982|||APPR|
N83038|S016|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|12/29/1982|03/02/1983|||APPR|
N83038|S017|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|01/18/1983|03/15/1983|||APPR|
N83038|S018|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|11/29/1983|04/27/1984|||APPR|
N83038|S019|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|06/22/1984|09/17/1985|||APPR|
N83038|S020|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT STERILE ABSORBABLE SUTURES|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/1986|02/20/1987|||APPR|
N83074|S001|LOOK, INC.|2020 LONNIE ABBOTT IND. BLVD.||ADA|OK|74820||MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)|NON-ABSORBABLE BLACK SILK SUTURE|CAP|SU|||N|07/10/1984|03/22/1985|||APPR|
N83074|S002|LOOK, INC.|2020 LONNIE ABBOTT IND. BLVD.||ADA|OK|74820||MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)|NON-ABSORBABLE BLACK SILK SUTURE|CAP|SU|||N|03/21/1986|06/09/1986|||APPR|
N83074|S004|LOOK, INC.|2020 LONNIE ABBOTT IND. BLVD.||ADA|OK|74820||MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)|NON-ABSORBABLE BLACK SILK SUTURE|CAP|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/1990|09/12/1990|||APPR|
N83433|S001|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|05/19/1981|09/01/1981|||APPR|
N83433|S002|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|10/02/1981|05/20/1982|||APPR|
N83433|S009|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|04/12/1978|11/23/1981|||APPR|
N83433|S010|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|04/12/1978|11/23/1981|||APPR|
N83433|S011|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|04/12/1978|11/23/1981|||APPR|
N83433|S012|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|05/21/1982|10/26/1982|||APPR|
N83433|S013|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|06/17/1982|07/16/1982|||APPR|
N83433|S014|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|06/17/1982|07/16/1982|||APPR|
N83433|S015|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|12/29/1982|03/02/1983|||APPR|
N83433|S016|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|01/18/1983|03/15/1983|||APPR|
N83433|S017|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|02/18/1983|04/07/1983|||APPR|
N83433|S018|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|03/21/1983|08/18/1983|||APPR|
N83433|S019|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|||N|06/22/1984|09/17/1985|||APPR|
N83433|S020|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT STERILE ABSORBABLE SUTURES|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/1986|02/20/1987|||APPR|
N83509|S001|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|||N|02/01/1980|01/02/1981|||APPR|
N83509|S002|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|||N|12/16/1980|07/20/1981|||APPR|
N83509|S004|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|||N|12/15/1981|05/18/1982|||APPR|
N83509|S005|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|||N|06/17/1982|07/16/1982|||APPR|
N83509|S006|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|||N|06/17/1982|07/16/1982|||APPR|
N83509|S007|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|||N|12/29/1982|03/02/1983|||APPR|
N83509|S008|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/1986|09/30/1986|||APPR|
N83509|S009|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1986|11/17/1986|||APPR|
N83509|S010|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/1986|02/20/1987|||APPR|
N83509|S011|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NON-ABSORBABLE (POLYESTER FIBER) SUTURES|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1987|06/05/1987|||APPR|
N83511|S001|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|||N|12/16/1980|07/20/1981|||APPR|
N83511|S002|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|||N|08/26/1981|10/20/1981|||APPR|
N83511|S004|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|||N|12/15/1981|05/18/1982|||APPR|
N83511|S005|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|||N|12/29/1982|03/02/1983|||APPR|
N83511|S006|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/1986|09/30/1986|||APPR|
N83511|S007|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1986|11/17/1986|||APPR|
N83511|S008|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/1986|02/20/1987|||APPR|
N83511|S009|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/1986|02/20/1987|||APPR|
N83511|S010|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyamide|NON-ABSORBABLE SUTURES NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1987|06/05/1987|||APPR|
N84047|S001|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|||N|09/12/1980|01/23/1981|||APPR|
N84047|S002|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|||N|12/16/1980|07/20/1981|||APPR|
N84047|S004|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|||N|12/15/1981|05/18/1982|||APPR|
N84047|S006|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|||N|06/17/1982|07/16/1982|||APPR|
N84047|S007|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|||N|06/17/1982|07/16/1982|||APPR|
N84047|S008|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|||N|12/29/1982|03/02/1983|||APPR|
N84047|S010|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|||N|04/29/1986|07/02/1986|||APPR|
N84047|S011|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/1986|09/30/1986|||APPR|
N84047|S012|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/1986|11/17/1986|||APPR|
N84047|S013|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/1986|05/27/1987|||APPR|
N84047|S014|DAVIS & GECK, INC.|AMERICAN CYNAMID COMPANY|ONE CASPER STREET|DANBURY|CT|06810||SUTURE, NONABSORBABLE, SILK|SILK NONABSORBABLE SUTURES, USP|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1987|06/05/1987|||APPR|
N84348|S001|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SILK|NONABSORBABLE SURG. SUTURES, BRAIDED SILK|GAP|SU|||N|09/23/1980|12/31/1980|||APPR|
N84348|S002|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SILK|NONABSORBABLE SURG. SUTURES, BRAIDED SILK|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1987|07/14/1988|||APPR|
N84348|S003|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SILK|NONABSORBABLE SURG. SUTURES, BRAIDED SILK|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1987|02/22/1988|||APPR|
N84348|S004|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SILK|NONABSORBABLE SURG. SUTURES, BRAIDED SILK|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/1987|01/31/1989|||APPR|
N84348|S005|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SILK|NONABSORBABLE SURG. SUTURES, BRAIDED SILK|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/1988|04/28/1988|||APPR|
N84348|S006|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SILK|NONABSORBABLE SURG. SUTURES, BRAIDED SILK|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/1989|06/16/1989|||APPR|
N84380|S001|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT SUTURES|GAL|SU|||N|02/05/1981|05/01/1981|||APPR|
N84380|S002|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT|GAL|SU|||N|04/08/1981|08/11/1981|||APPR|
N84380|S003|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT SUTURES|GAL|SU|||N|04/14/1983|06/14/1983|||APPR|
N84380|S004|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT SUTURES|GAL|SU|||N|05/09/1984|07/12/1984|||APPR|
N84380|S005|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT SUTURES|GAL|SU|||N|06/21/1984|02/27/1985|||APPR|
N84380|S006|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT SUTURES|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1987|02/22/1988|||APPR|
N84380|S007|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT SUTURES|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/1987|01/31/1989|||APPR|
N84380|S008|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|PLAIN GUT SUTURES|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/1988|04/28/1988|||APPR|
N84381|S001|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT SUTURE|GAL|SU|||N|02/05/1981|05/01/1981|||APPR|
N84381|S002|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|GUT|GAL|SU|||N|04/08/1981|08/11/1981|||APPR|
N84381|S003|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT SUTURE|GAL|SU|||N|04/14/1983|06/14/1983|||APPR|
N84381|S004|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT SUTURE|GAL|SU|||N|05/09/1984|07/12/1984|||APPR|
N84381|S005|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT SUTURE|GAL|SU|||N|06/21/1984|02/27/1985|||APPR|
N84381|S006|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT SUTURE|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1987|02/22/1988|||APPR|
N84381|S007|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT SUTURE|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/1987|01/31/1989|||APPR|
N84381|S008|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, ABSORBABLE, NATURAL|CHROMIC GUT SUTURE|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/1988|04/28/1988|||APPR|
N85060|S001|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||Suture, nonabsorbable, synthetic, polyamide|NONABSORBABLE SURG. SUTURES, NYLON|GAR|SU|||N|09/23/1980|12/31/1980|||APPR|
N85060|S002|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||Suture, nonabsorbable, synthetic, polyamide|NONABSORBABLE SURG. SUTURES, NYLON|GAR|SU|||N|06/21/1984|02/27/1985|||APPR|
N85060|S003|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||Suture, nonabsorbable, synthetic, polyamide|NONABSORBABLE SURG. SUTURES, NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1987|07/14/1988|||APPR|
N85060|S004|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||Suture, nonabsorbable, synthetic, polyamide|NONABSORBABLE SURG. SUTURES, NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1987|02/22/1988|||APPR|
N85060|S005|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||Suture, nonabsorbable, synthetic, polyamide|NONABSORBABLE SURG. SUTURES, NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/1987|01/31/1989|||APPR|
N85060|S006|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||Suture, nonabsorbable, synthetic, polyamide|NONABSORBABLE SURG. SUTURES, NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/1988|04/28/1988|||APPR|
N85060|S007|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||Suture, nonabsorbable, synthetic, polyamide|NONABSORBABLE SURG. SUTURES, NYLON|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/1989|06/16/1989|||APPR|
N85143|S001|SHARPOINT, INC.|824 TWELFTH AVE.||BETHLEHEM|PA|18018||SUTURE, NONABSORBABLE, SILK|SUTURES|GAP|SU|||N|12/26/1984|10/27/1986|||APPR|
N85143|S002|SHARPOINT, INC.|824 TWELFTH AVE.||BETHLEHEM|PA|18018||SUTURE, NONABSORBABLE, SILK|SUTURES|GAP|SU|Normal 180 Day Track|Other Report|N|02/13/1987|04/03/1987|||APPR|
N85143|S003|SHARPOINT, INC.|824 TWELFTH AVE.||BETHLEHEM|PA|18018||SUTURE, NONABSORBABLE, SILK|SUTURES|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/1987|08/27/1987|||APPR|
N85143|S004|SHARPOINT, INC.|824 TWELFTH AVE.||BETHLEHEM|PA|18018||SUTURE, NONABSORBABLE, SILK|SILK SURGICAL SUTURES|GAP|SU|Normal 180 Day Track|Other Report|N|06/03/1987|08/31/1988|||APPR|
N85143|S005|SHARPOINT, INC.|824 TWELFTH AVE.||BETHLEHEM|PA|18018||SUTURE, NONABSORBABLE, SILK|SILK SURGICAL SUTURES|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/1987|10/13/1987|||APPR|
N85143|S006|SHARPOINT, INC.|824 TWELFTH AVE.||BETHLEHEM|PA|18018||SUTURE, NONABSORBABLE, SILK|SILK SURGICAL SUTURES|GAP|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1988|03/22/1988|||APPR|
N85143|S007|SHARPOINT, INC.|824 TWELFTH AVE.||BETHLEHEM|PA|18018||SUTURE, NONABSORBABLE, SILK|SILK SURGICAL SUTURES|GAP|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1988|07/19/1988|||APPR|
N85316|S001|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|11/19/1980|01/06/1981|||APPR|
N85316|S002|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON!NUROLON NYLON SUTURE, USP|GAR|SU|||N|12/04/1980|07/07/1981|||APPR|
N85316|S003|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|05/19/1981|08/11/1981|||APPR|
N85316|S004|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|08/11/1981|10/26/1981|||APPR|
N85316|S005|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|03/04/1982|09/09/1982|||APPR|
N85316|S006|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|05/13/1982|07/09/1982|||APPR|
N85316|S007|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|02/16/1983|06/07/1983|||APPR|
N85316|S008|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|03/30/1983|05/20/1983|||APPR|
N85316|S009|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|06/20/1983|09/28/1983|||APPR|
N85316|S010|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|08/08/1983|11/14/1983|||APPR|
N85316|S011|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|06/04/1984|07/11/1984|||APPR|
N85316|S012|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|||N|10/21/1985|06/20/1986|||APPR|
N85316|S013|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1986|12/03/1986|||APPR|
N85316|S014|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N85316|S015|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/1987|08/28/1987|||APPR|
N85316|S016|ETHICON, INC.|ROUTE 22 WEST|PO BOX 151|SOMERVILLE|NJ|08876||Suture, nonabsorbable, synthetic, polyamide|ETHILON/NUROLON NYLON SUTURES|GAR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1988|12/22/1988|||APPR|
N85356|S001|HUBINGER CO.|601 MAIN ST.||KEOKUK|IA|52632||POWDER, DUSTING, SURGICAL|ABSORBABLE DUSTING POWDER|KGP|HO|||N|01/01/1900|12/20/1978|||APPR|
N8536|S001|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|12/01/1980|01/06/1981|||APPR|
N8536|S008|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|10/21/1980|01/06/1981|||APPR|
N8536|S009|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|11/19/1980|01/06/1981|||APPR|
N8536|S010|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE (PLAIN!CHROMIC) ABSORBABLE|GAL|SU|||N|12/04/1980|07/07/1981|||APPR|
N8536|S011|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|Normal 180 Day Track||N|02/05/1981|04/24/1981|||APPR|
N8536|S012|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|05/19/1981|08/11/1981|||APPR|
N8536|S013|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|05/19/1981|07/28/1981|||APPR|
N8536|S014|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|03/04/1982|07/21/1982|||APPR|
N8536|S015|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|07/23/1982|12/22/1982|||APPR|
N8536|S016|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|12/08/1982|07/05/1983|||APPR|
N8536|S017|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|02/24/1983|04/04/1983|||APPR|
N8536|S018|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|03/30/1983|06/07/1983|||APPR|
N8536|S019|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|05/09/1983|11/17/1983|||APPR|
N8536|S020|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|09/09/1983|11/17/1983|||APPR|
N8536|S021|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|01/26/1984|04/04/1984|||APPR|
N8536|S022|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|||N|10/21/1985|06/20/1986|||APPR|
N8536|S023|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1987|06/18/1987|||APPR|
N8536|S024|ETHICON, INC.|P.O BOX 151, ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, ABSORBABLE, NATURAL|CATGUT SUTURE|GAL|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1988|12/22/1988|||APPR|
P760001|S001|ALERE, INC.|10 Southgate Road||Scarborough|ME|04074||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AFP RIA KIT|LOK|IM|Normal 180 Day Track||N|06/22/1982|03/01/1984|||APPR|
P770010|S001|MEDISERVE INTERNATIONAL, INC.|GRANGER, INDIANA||||||TEST REAGENTS, NEISSERIA GONORRHOEAE BIOCHEMICAL|GONODECTEN|LTS|MI|||N|06/10/1980|06/10/1980|||APPR|
P770010|S002|MEDISERVE INTERNATIONAL, INC.|GRANGER, INDIANA||||||TEST REAGENTS, NEISSERIA GONORRHOEAE BIOCHEMICAL|GONODECTEN|LTS|MI|||N|10/14/1981|11/19/1981|||APPR|
P780002|S001|SYNOVIS SURGICAL INNOVATIONS|2575 UNIVERSITY AVE. WEST||ST. PAUL|MN|55114|1024|TISSUE GRAFT OF 6MM AND GREATER|DARDIK BIOGRAFT FOR USE IN PERIPHERAL VASCULAR SUR|LXA|CV|||N|03/12/1981|07/10/1981|||APPR|
P780002|S002|SYNOVIS SURGICAL INNOVATIONS|2575 UNIVERSITY AVE. WEST||ST. PAUL|MN|55114|1024|TISSUE GRAFT OF 6MM AND GREATER|DARDIK BIOGRAFT|LXA|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/1980|12/01/1981|||APPR|
P780002|S004|SYNOVIS SURGICAL INNOVATIONS|2575 UNIVERSITY AVE. WEST||ST. PAUL|MN|55114|1024|TISSUE GRAFT OF 6MM AND GREATER|DARDIK BIOGRAFT|LXA|CV|||N|11/12/1981|11/30/1981|||APPR|
P780002|S005|SYNOVIS SURGICAL INNOVATIONS|2575 UNIVERSITY AVE. WEST||ST. PAUL|MN|55114|1024|TISSUE GRAFT OF 6MM AND GREATER|DARDIK BIOGRAFT|LXA|CV|||N|03/12/1984|05/19/1986|||APPR|
P780002|S008|SYNOVIS SURGICAL INNOVATIONS|2575 UNIVERSITY AVE. WEST||ST. PAUL|MN|55114|1024|TISSUE GRAFT OF 6MM AND GREATER|DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE|LXA|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/1990|09/11/1990|||APPR|
P780005|S001|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA AP6C-2|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT AFP|LOK|IM|||N|12/16/1983|04/24/1985|||APPR|
P780006|S002|EASTMAN KODAK COMPANY|BLDG.15,6TH FLOOR|343 STATE STREET|ROCHESTER|NY|14650|1252|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AMERSHAM AFP|LOK|IM|||N|10/31/1985|03/17/1986|||APPR|
P780006|S003|EASTMAN KODAK COMPANY|BLDG.15,6TH FLOOR|343 STATE STREET|ROCHESTER|NY|14650|1252|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AMERSHAM AFP|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1989|09/26/1989|||APPR|
P780007|S001|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON SEMI SCLERAL, MINI, TORIC|LPL|OP|Normal 180 Day Track||N|09/27/1979|12/17/1979|||APPR|
P780007|S002|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON SEMI SCLERAL, MINI, TORIC|LPL|OP|||N|10/31/1979|01/30/1980|||APPR|
P780007|S003|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON SEMI SCLERAL, MINI, TORIC|LPL|OP|||N|10/31/1979|03/14/1980|||APPR|
P780007|S004|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON SEMI SCLERAL, MINI, TORIC|LPL|OP|||N|11/19/1979|03/18/1980|||APPR|
P780007|S005|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON SEMI SCLERAL, MINI, TORIC|LPL|OP|||N|02/01/1980|06/05/1980|||APPR|
P780007|S006|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON SEMI SCLERAL, MINI, TORIC|LPL|OP|||N|04/15/1980|11/07/1980|||APPR|
P780007|S007|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track||N|11/07/1980|06/02/1981|||APPR|
P780007|S008|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|07/31/1981|12/10/1981|||APPR|
P780007|S009|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|03/09/1982|03/25/1982|||APPR|
P780007|S010|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|04/29/1982|06/22/1982|||APPR|
P780007|S012|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|04/29/1982|06/22/1982|||APPR|
P780007|S014|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|09/02/1983|03/29/1984|||APPR|
P780007|S015|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|01/26/1984|08/21/1984|||APPR|
P780007|S016|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|07/27/1984|08/09/1985||11/18/1985|APPR|
P780007|S017|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|C&H SOFT (POLYMACON) HYDROPHILIC CONTACT LENSES|LPL|OP|||N|09/10/1984|07/25/1985|||APPR|
P780007|S018|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|10/09/1984|05/30/1985|||APPR|
P780007|S019|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|10/11/1984|03/05/1985|||APPR|
P780007|S020|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|11/07/1984|01/22/1986|||APPR|
P780007|S023|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|||N|02/25/1985|12/09/1985|||APPR|
P780007|S024|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1986|11/14/1986|||APPR|
P780007|S025|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1986|06/22/1987|||APPR|
P780007|S026|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1986|05/19/1988|||APPR|
P780007|S027|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/28/1987|06/16/1987|||APPR|
P780007|S028|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/1988|03/18/1988|88M-0129|06/08/1988|APPR|
P780007|S029|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/1988|09/30/1988|||APPR|
P780007|S031|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1988|09/20/1988|||APPR|
P780007|S032|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/1988|01/03/1989|||APPR|
P780007|S033|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/09/1989|06/26/1989|||APPR|
P780007|S034|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|9YDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|12/28/1989|||APPR|
P780007|S035|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1990|01/14/1992|||APPR|
P780007|S036|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/1990|09/10/1991|||APPR|
P780007|S037|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRON HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/17/1991|01/31/1992|||APPR|
P780007|S038|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|POLYMACON CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1992|04/12/1993|||APPR|
P780007|S039|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|POLYMACON CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/1993|11/23/1993|||APPR|
P780008|S005|SHILEY, INC.|17600 GILLETTE AVE.|P.O. BOX 19503|IRVINE|CA|92714||HEART-VALVE, MECHANICAL|BJORK-SHILEY CARDIAC VALVE|LWQ|CV|||N|10/26/1981|02/05/1982|||APPR|
P780008|S007|SHILEY, INC.|17600 GILLETTE AVE.|P.O. BOX 19503|IRVINE|CA|92714||HEART-VALVE, MECHANICAL|BJORK-SHILEY CARDIAC VALVE|LWQ|CV|||N|10/19/1982|05/20/1983|||APPR|
P780008|S011|SHILEY, INC.|17600 GILLETTE AVE.|P.O. BOX 19503|IRVINE|CA|92714||HEART-VALVE, MECHANICAL|BJORK-SHILEY CARDIAC VALVE|LWQ|CV|||N|08/08/1983|05/15/1984|||APPR|
P780008|S013|SHILEY, INC.|17600 GILLETTE AVE.|P.O. BOX 19503|IRVINE|CA|92714||HEART-VALVE, MECHANICAL|BJORK-SHILEY CARDIAC VALVE|LWQ|CV|||N|11/21/1983|10/31/1986|||APPR|
P780008|S014|SHILEY, INC.|17600 GILLETTE AVE.|P.O. BOX 19503|IRVINE|CA|92714||HEART-VALVE, MECHANICAL|BJORK-SHILEY CARDIAC VALVE|LWQ|CV|Normal 180 Day Track||N|08/22/1983|04/09/1985|||APPR|
P780008|S015|SHILEY, INC.|17600 GILLETTE AVE.|P.O. BOX 19503|IRVINE|CA|92714||HEART-VALVE, MECHANICAL|BJORK-SHILEY CARDIAC VALVE|LWQ|CV|||N|12/08/1983|11/26/1984|||APPR|
P780009|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|BYREL PROGRAMABLE PACEMAKER|LWP|CV|||N|06/12/1981|07/21/1981|||APPR|
P780010|S002|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS (PERFILCON) HYDROPHILIC CONTACT LENSES F|LPM|OP|||N|10/26/1979|03/02/1981|||APPR|
P780010|S008|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS (PERFILCON) HYDROPHILIC CONTACT LENS|LPM|OP|Normal 180 Day Track||N|12/29/1980|01/29/1981|||APPR|
P780010|S010|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|||N|04/18/1983|01/12/1984|||APPR|
P780010|S011|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|||N|05/16/1983|07/05/1983|||APPR|
P780010|S012|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|||N|05/24/1983|09/12/1983|||APPR|
P780010|S013|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|||N|11/18/1983|01/26/1984|||APPR|
P780010|S014|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|||N|07/11/1985|03/31/1986|||APPR|
P780010|S015|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/28/1988|05/25/1988|||APPR|
P780010|S016|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1989|06/13/1989|||APPR|
P780010|S017|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|YERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|09/18/1989|||APPR|
P780010|S018|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|YERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|Normal 180 Day Track|Other Report|N|07/24/1989|01/23/1990|||APPR|
P780010|S019|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS EXTENDED WEAR CONTACT LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1991|02/25/1992|||APPR|
P780011|S001|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI-BALLOON DETACHABLE BALLOON SYSTEM|KRD|CV|||N|02/26/1981|11/27/1981|||APPR|
P780011|S003|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|||N|02/26/1981|11/20/1981|||APPR|
P780011|S004|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|||N|02/26/1981|12/18/1981|||APPR|
P780011|S005|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|||N|05/12/1981|11/27/1981|||APPR|
P780011|S006|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|||N|05/03/1982|06/04/1982|||APPR|
P780011|S007|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|||N|08/16/1984|01/23/1985|||APPR|
P780011|S010|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/1987|01/29/1988|||APPR|
P780011|S011|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|Normal 180 Day Track|Other Report|N|05/31/1988|10/18/1988|||APPR|
P780011|S012|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Device, Vascular, for Promoting Embolization|MINI BALLOON|KRD|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/1989|10/30/1989|||APPR|
P780012|S001|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|HAVAB|LOL|MI|||N|10/04/1979|04/11/1980|||APPR|
P780012|S002|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|HAVAB|LOL|MI|||N|11/26/1979|04/04/1980|||APPR|
P780012|S003|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|HAVAB|LOL|MI|||N|02/23/1982|04/30/1982|||APPR|
P780012|S004|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|HAVAB|LOL|MI|||N|03/25/1982|06/25/1982|||APPR|
P780012|S005|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|IMX(R) HAVAB|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1991|10/25/1991|||APPR|
P780012|S006|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|IMX(R) HAVAB|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/10/1992|03/09/1992|||APPR|
P780012|S007|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|IMX(R) HAVAB|LOL|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/1992|09/12/1994|||APPR|
P780013|S001|GBF CONTACT LENSES, INC.|4217 VIRGINIA BEACH BLVD.||VIRGINIA BEACH|VA|23452||Lenses, soft contact, daily wear|TRI POL 43R HYDROPHILIC CONTACT LENS|LPL|OP|||N|08/13/1979|01/02/1980|||APPR|
P780013|S002|GBF CONTACT LENSES, INC.|4217 VIRGINIA BEACH BLVD.||VIRGINIA BEACH|VA|23452||Lenses, soft contact, daily wear|TRI POL 43 CONTACT LENS|LPL|OP|||N|01/10/1980|06/19/1980|||APPR|
P780013|S004|GBF CONTACT LENSES, INC.|4217 VIRGINIA BEACH BLVD.||VIRGINIA BEACH|VA|23452||Lenses, soft contact, daily wear|TRI POL 43 CONTACT LENS|LPL|OP|||N|08/15/1983|02/10/1984||04/17/1984|APPR|
P780013|S005|GBF CONTACT LENSES, INC.|4217 VIRGINIA BEACH BLVD.||VIRGINIA BEACH|VA|23452||Lenses, soft contact, daily wear|TRI POL 43 CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/25/1989|02/26/1991|||APPR|
P780013|S006|GBF CONTACT LENSES, INC.|4217 VIRGINIA BEACH BLVD.||VIRGINIA BEACH|VA|23452||Lenses, soft contact, daily wear|V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/1991|08/13/1991|||APPR|
P780013|S007|GBF CONTACT LENSES, INC.|4217 VIRGINIA BEACH BLVD.||VIRGINIA BEACH|VA|23452||Lenses, soft contact, extended wear|V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/1992|05/19/1993|||APPR|
P780016|S001|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|CORAB|LOM|MI|||N|11/13/1979|04/11/1980|||APPR|
P780016|S002|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|CORAB|LOM|MI|||N|11/26/1979|03/17/1980|||APPR|
P780016|S003|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|CORAB|LOM|MI|||N|02/04/1982|03/15/1982|||APPR|
P780016|S004|Abbott Laboratories|100 ABBOTT PARK ROAD|DEPT 9VA AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|CORAB|LOM|MI|||N|01/03/1984|10/11/1984|||APPR|
P790001|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COLD DISINFECTION REGIMEN|LPN|OP|||N|10/01/1979|01/02/1980|||APPR|
P790001|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COLD DISINFECTION REGIMEN|LPN|OP|||N|06/24/1980|07/20/1981|||APPR|
P790001|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COLD DISINFECTION REGIMEN|LPN|OP|||N|06/22/1981|03/03/1982|||APPR|
P790001|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COLD DISINFECTION REGIMEN|LPN|OP|||N|08/12/1985|12/31/1985|||APPR|
P790001|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COLD DISINFECTION REGIMEN|LPN|OP|||N|01/21/1986|04/16/1986|||APPR|
P790001|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|3-SOLUTION DISINFECTION REGIMEN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/1986|10/27/1986|||APPR|
P790001|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|3-SOLUTION DISINFECTION REGIMEN|LPN|OP|Normal 180 Day Track|Other Report|N|11/06/1986|12/01/1986|||APPR|
P790002|S001|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIO OSTEOGEN SYSTEM 204|LOF|OR|||N|04/01/1982|05/19/1982|||APPR|
P790002|S002|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIO OSTEOGEN SYSTEM 204|LOF|OR|||N|07/15/1982|08/20/1982|||APPR|
P790002|S003|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIO OSTEOGEN SYSTEM 204|LOF|OR|||N|09/15/1982|12/22/1982|||APPR|
P790002|S004|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIO OSTEOGEN SYSTEM 204|LOF|OR|||N|03/02/1983|10/03/1983|||APPR|
P790002|S006|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIO OSTEOGEN SYSTEM 204|LOF|OR|||N|04/15/1985|08/20/1985|||APPR|
P790002|S008|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM MODEL 1020|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/1986|06/26/1987|||APPR|
P790002|S009|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/1987|06/23/1987|||APPR|
P790002|S010|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/02/1989|04/05/1990|||APPR|
P790002|S011|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/14/1989|08/10/1989|||APPR|
P790002|S012|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1989|12/13/1989|||APPR|
P790002|S013|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)-MODEL 1026|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1991|04/12/1993|||APPR|
P790002|S014|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)-MODEL 123|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/1992|06/14/1993|||APPR|
P790002|S015|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/1994|03/12/1998|||APPR|Approval for the FLX(R)-S Coils (model numbers FLX 2-S, FLX 3-S, and FLX 4-S) which will be used to deliver the single repetitive pulse (SRP) signal produced by the EBI Bone Healing System(R) Model 1020-S control unit.  The device, as modified, will be marketed under the trade name EBI FLX(R)-S Coils and used with the EBI Bone Healing System(R) Model 1020-S control unit which is indicated for the treatment of nonunions, failed fusions, and congenital pseudarthroses.
P790005|S001|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOTIM BGS|LOE|OR|||N|03/17/1980|03/17/1980|||APPR|
P790005|S003|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|||N|10/27/1980|01/23/1981|||APPR|
P790005|S004|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|TELECTRONICS OSTEOSTIM BONW GROWTH STIMULATOR MODE|LOE|OR|Normal 180 Day Track||N|12/16/1980|02/03/1981|||APPR|
P790005|S006|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|||N|04/06/1981|07/09/1981|||APPR|
P790005|S007|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|||N|05/22/1981|07/15/1981|||APPR|
P790005|S009|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|||N|07/29/1981|09/08/1981|||APPR|
P790005|S010|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|||N|09/24/1981|12/24/1981|||APPR|
P790005|S011|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|||N|03/03/1982|04/14/1982|||APPR|
P790005|S012|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|||N|03/08/1982|03/26/1982|||APPR|
P790005|S013|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|||N|04/13/1982|05/18/1982|||APPR|
P790005|S016|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|STIMETICS|LOE|OR|||N|03/07/1983|06/14/1983|||APPR|
P790005|S021|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|07/20/1983|10/14/1983|||APPR|
P790005|S022|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|08/31/1983|10/26/1983|||APPR|
P790005|S023|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|09/21/1983|04/04/1984|||APPR|
P790005|S024|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|10/04/1983|11/17/1983|||APPR|
P790005|S025|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|11/28/1983|12/23/1983|||APPR|
P790005|S026|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|06/13/1985|09/04/1985|||APPR|
P790005|S027|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|09/06/1985|12/22/1986|||APPR|
P790005|S028|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|||N|10/30/1985|12/22/1986|||APPR|
P790005|S029|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(R)|LOE|OR|Normal 180 Day Track|Other Report|N|11/07/1986|12/03/1986|||APPR|
P790005|S030|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Other Report|N|06/10/1987|06/23/1987|||APPR|
P790005|S031|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/1988|04/21/1988|||APPR|
P790005|S032|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1988|04/21/1988|||APPR|
P790005|S033|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/22/1989|04/05/1990|||APPR|
P790005|S034|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/1990|04/25/1990|||APPR|
P790005|S035|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/1990|10/22/1990|||APPR|
P790005|S037|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|ORTHOGEN/OSTEOGEN IMPLANT. BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/1994|04/06/1995|||APPR|
P790006|S001|Allergan, Inc.|5540 EKWILL STREET||SANTA BARBARA|CA|93111||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|ANTI-REFLUX PROSTHESIS|LEI|GU|||N|01/10/1980|09/10/1980|||APPR|
P790006|S002|Allergan, Inc.|5540 EKWILL STREET||SANTA BARBARA|CA|93111||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|ANGEL CHIK ANTI-REFLUX PROSTHESIS|LEI|GU|||N|04/02/1981|05/14/1981|||APPR|
P790006|S003|Allergan, Inc.|5540 EKWILL STREET||SANTA BARBARA|CA|93111||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|ANGELCHIK ANTI-REFLUX PROSTHESIS|LEI|GU|||N|06/13/1983|07/02/1984|||APPR|
P790006|S004|Allergan, Inc.|5540 EKWILL STREET||SANTA BARBARA|CA|93111||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|ANGELCHIK ANTI-REFLUX PROSTHESIS|LEI|GU|||N|05/03/1984|07/02/1984|||APPR|
P790006|S005|Allergan, Inc.|5540 EKWILL STREET||SANTA BARBARA|CA|93111||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|ANGELCHIK ANTI-REFLUX PROSTHESIS|LEI|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/1990|10/25/1990|||APPR|
P790007|S001|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS|LWR|CV|||N|12/27/1979|03/06/1980|||APPR|
P790007|S002|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS|LWR|CV|||N|12/27/1979|01/30/1980|||APPR|
P790007|S003|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE AORTIC BIOPROSTHESIS|LWR|CV|||N|12/27/1979|03/06/1980|||APPR|
P790007|S004|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|||N|10/06/1980|09/01/1981|||APPR|
P790007|S005|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS|LWR|CV|||N|05/04/1981|09/01/1981|||APPR|
P790007|S007|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS|LWR|CV|||N|02/08/1985|05/30/1985|||APPR|
P790007|S009|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/1989|11/14/1989|||APPR|
P790007|S010|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/1992|02/02/1993|||APPR|
P790007|S011|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/1992|07/02/1993|||APPR|
P790007|S012|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE BIOPROSTHESIS MODEL 250|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/1993|12/08/1993|||APPR|
P790008|S001|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Stimulator, invasive bone growth|ZIMMER DIRECT CURRENT BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track||N|03/08/1982|05/03/1982|||APPR|
P790008|S003|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Stimulator, invasive bone growth|ZIMMER DIRECT CURRENT BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track||N|07/29/1982|08/17/1982|||APPR|
P790008|S004|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Stimulator, invasive bone growth|ZIMMER DIRECT CURRENT BONE GROWTH STIMULATOR|LOE|OR|THIRTY DAY TRACK|Other Report|N|03/02/1988|04/21/1988|||APPR|
P790008|S005|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Stimulator, invasive bone growth|~[24~R DIRECT CURRENT BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/1989|03/29/1991|||APPR|
P790010|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, extended wear|DANKER SILICONE LENS (DIMEFOCON-A)|LPM|OP|||N|06/25/1982|08/25/1982|||APPR|
P790010|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, extended wear|DANKER SILICONE LENS (DIMEFOCON-A)|LPM|OP|||N|12/15/1982|09/15/1983|||APPR|
P790010|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, extended wear|DANKER SILICONE LENS (DIMEFOCON-A)|LPM|OP|||N|06/23/1983|12/13/1984|||APPR|
P790010|S005|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, extended wear|DANKER SILICONE LENS (DIMEFOCON-A)|LPM|OP|||N|05/25/1984|08/16/1985|||APPR|
P790010|S006|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, extended wear|DANKER SILICONE LENS (DIMEFOCON-A)|LPM|OP|Normal 180 Day Track|Other Report|N|09/24/1987|12/29/1987|||APPR|
P790010|S007|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, extended wear|DANKER SILICONE LENS (DIMEFOCON-A)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/23/1990|||APPR|
P790011|S001|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|06/24/1980|12/31/1980|||APPR|
P790011|S002|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|04/02/1981|09/23/1981|||APPR|
P790011|S003|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|04/28/1981|09/01/1981|||APPR|
P790011|S005|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|06/08/1982|07/27/1982|||APPR|
P790011|S006|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|06/25/1982|02/02/1983|||APPR|
P790011|S007|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|04/18/1983|06/07/1983|||APPR|
P790011|S008|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|07/13/1983|09/13/1983|||APPR|
P790011|S009|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|09/13/1983|12/05/1983|||APPR|
P790011|S010|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|||N|04/23/1985|12/09/1985|||APPR|
P790011|S011|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1986|05/25/1988|||APPR|
P790011|S012|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/1987|09/09/1987|||APPR|
P790011|S013|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/1987|07/02/1987|||APPR|
P790011|S014|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/1987|10/18/1988|||APPR|
P790011|S015|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/1987|03/14/1988|||APPR|
P790011|S016|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/1989|08/30/1989|||APPR|
P790011|S017|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/1989|06/01/1989|||APPR|
P790011|S018|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/1989|08/01/1989|||APPR|
P790011|S020|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|UNISOL PLUS(TM) PH BALANCED SALINE SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P790015|S002|ADVANCED SOFT OPTICS, INC.|113 23RD AVE N.||NASHVILLE|TN|||Lenses, soft contact, daily wear|SOFTICS (DELTAFILCON A) LENS|LPL|OP|||N|04/02/1980|04/25/1980|||APPR|
P790017|S001|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CORNARY BALLOON DILATATION CA|LOX|CV|Normal 180 Day Track||N|12/22/1980|02/17/1981|||APPR|
P790017|S002|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|||N|08/04/1981|09/30/1981|||APPR|
P790017|S003|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|||N|08/04/1981|09/30/1981|||APPR|
P790017|S004|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|||N|05/18/1982|10/04/1982|||APPR|
P790017|S005|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|||N|10/25/1982|12/27/1982|||APPR|
P790017|S006|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|||N|11/05/1982|01/12/1983|||APPR|
P790017|S007|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|||N|07/22/1983|12/14/1983|||APPR|
P790017|S008|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|PLUS XX AND PROFILE PLUS|LOX|CV|Normal 180 Day Track||N|10/12/1983|10/07/1986|||APPR|
P790017|S009|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|||N|01/19/1984|02/22/1984|||APPR|
P790017|S011|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|||N|06/14/1985|06/15/1987|||APPR|
P790017|S012|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI{R} SLIDEWIRE{TM} STEERABLE GUIDE WIRES|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1986|10/31/1986|||APPR|
P790017|S013|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/1987|06/15/1987|||APPR|
P790017|S015|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/15/1987|11/13/1987|||APPR|
P790017|S016|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/1987|02/19/1988|||APPR|
P790017|S017|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1987|03/18/1988|||APPR|
P790017|S018|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/1987|06/07/1988|||APPR|
P790017|S019|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/1988|05/17/1988|||APPR|
P790017|S020|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/1988|05/24/1988|||APPR|
P790017|S021|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1988|06/09/1988|||APPR|
P790017|S022|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/1988|03/14/1991|||APPR|
P790017|S025|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/1988|01/19/1989|||APPR|
P790017|S026|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/1989|06/07/1989|||APPR|
P790017|S027|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/1989|12/14/1989|||APPR|
P790017|S028|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/1989|09/19/1989|||APPR|
P790017|S031|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/1989|09/14/1989|||APPR|
P790017|S039|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) FORCE(R) BALL. DIL. CATH. W/PRO/PEL COAT.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/1991|12/06/1991|||APPR|
P790017|S040|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) SPRINT(TM) BALL. DIL. CATH. W/PRO/PEL COAT|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/1991|12/06/1991|||APPR|
P790017|S041|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) SOLO(TM) BALL. DIL. CATH. W/PRO/PEL COAT|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1991|10/20/1992|||APPR|
P790017|S043|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) SPRINT(TM) BALL. DIL. CATH. WITH BANKA(TM)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/1992|06/04/1993|||APPR|
P790017|S044|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1992|01/07/1994|||APPR|
P790017|S045|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/1991|01/07/1994|||APPR|
P790017|S046|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R)SOLITAIRE(TM) BALL.DIL.CATH.W/PRO/PEL(TM)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/1992|05/20/1993|||APPR|
P790017|S047|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) XPRT(TM) BALL. DIL. CATH. W/PRO/PEL(TM)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/1992|05/20/1993|||APPR|
P790017|S049|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R)BALLOON DILATATION CATH. W/PETELITE(TM)|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1992|02/26/1996|||APPR|APPROVAL FOR MANUFACTURING CHANGES TO THE BALLOON AND INCLUDED THE USE OF A BALLOON PROTECTOR. THE DEVICES, AS MODIFIED, WILL BE MARKETED WITH THE PETELITE BALLOON DESIGNATION
P790017|S052|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R)GRUNTZIG DILACA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/1993|04/18/1996|||APPR|APPROVAL FOR A STERILIZATION SITE CHANGE AND A CHANGE IN THE STERILIZATION CYCLE
P790018|S001|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|02/02/1982|03/26/1982|||APPR|
P790018|S002|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|02/12/1982|06/25/1982|||APPR|
P790018|S003|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|07/29/1982|09/22/1982|||APPR|
P790018|S004|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|11/24/1982|01/12/1983|||APPR|
P790018|S005|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|06/13/1983|06/03/1986|||APPR|
P790018|S006|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|12/07/1983|12/05/1985|||APPR|
P790018|S007|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|02/29/1984|09/24/1985|||APPR|
P790018|S008|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|09/22/1983|11/01/1985|||APPR|
P790018|S010|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|05/02/1984|02/08/1985|||APPR|
P790018|S012|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|12/06/1984|09/24/1985|||APPR|
P790018|S013|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|12/04/1985|05/09/1988|||APPR|
P790018|S014|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|||N|12/06/1985|05/09/1988|||APPR|
P790018|S016|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1989|03/27/1990|||APPR|
P790018|S017|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Other Report|N|12/10/1991|08/25/1992|||APPR|
P790018|S018|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/10/1992|02/25/1992|||APPR|
P790018|S019|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (22MM)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/1992|11/06/1992|||APPR|
P790018|S020|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Other Report|N|04/16/1992|09/03/1992|||APPR|
P790018|S021|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Other Report|N|01/06/1993|01/29/1993|||APPR|
P790018|S022|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1993|05/09/1994|||APPR|
P790018|S023|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|4EDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Other Report|N|03/25/1994|04/12/1994|||APPR|
P790019|S001|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M DIAGNOSTIC KIT|LOL|MI|||N|02/23/1982|04/30/1982|||APPR|
P790019|S002|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M DIAGNOSTIC KIT|LOL|MI|||N|03/04/1982|06/25/1982|||APPR|
P790019|S004|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M DIAGNOSTIC KIT|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1990|10/16/1990|||APPR|
P790019|S005|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M DIAGNOSTIC KIT|LOL|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/1992|09/12/1994|||APPR|
P790020|S001|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SOFLOW PW (LIDOFILCON B)|LPM|OP|||N|05/02/1980|06/16/1981||03/04/1981|APPR|
P790020|S002|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) 70 (LIDOFILCON A)|LPM|OP|||N|09/01/1981|09/23/1982||05/10/1985|APPR|
P790020|S003|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SOFLOW PW (LIDOFILCON B)|LPM|OP|||N|09/21/1981|11/09/1981|||APPR|
P790020|S004|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLOW(R) PW (LIDOFILCON B) CONTACT LENS|LPM|OP|||N|12/04/1981|04/08/1982|||APPR|
P790020|S005|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|05/03/1982|06/22/1982|||APPR|
P790020|S006|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SOFT MATE(R) CLEANING & DISINFECTING SOLN.|LPM|OP|||N|05/18/1982|07/21/1982|||APPR|
P790020|S008|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|08/26/1982|05/09/1983||05/10/1985|APPR|
P790020|S009|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|09/29/1982|11/23/1982|||APPR|
P790020|S010|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|06/15/1982|12/05/1983|||APPR|
P790020|S011|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|06/08/1983|06/08/1984|||APPR|
P790020|S012|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|06/08/1983|09/08/1983|||APPR|
P790020|S013|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|07/01/1983|07/03/1983|||APPR|
P790020|S015|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|GENESIS-4 (LIDOFILCON A)|LPM|OP|||N|09/09/1983|12/23/1983|||APPR|
P790020|S017|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|10/06/1983|11/17/1983|||APPR|
P790020|S018|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|11/23/1983|04/10/1984|||APPR|
P790020|S019|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|11/30/1983|07/17/1984|||APPR|
P790020|S021|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|01/10/1984|08/02/1984|||APPR|
P790020|S022|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|01/11/1984|02/22/1984|||APPR|
P790020|S023|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|02/06/1984|03/01/1984|||APPR|
P790020|S024|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|05/15/1984|05/02/1985|||APPR|
P790020|S025|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|05/17/1984|04/12/1985|||APPR|
P790020|S027|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|05/30/1984|06/05/1985|||APPR|
P790020|S028|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|06/26/1984|04/09/1985|||APPR|
P790020|S029|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|07/02/1984|07/10/1985|||APPR|
P790020|S030|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|10/01/1984|05/21/1985|||APPR|
P790020|S031|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|03/25/1985|09/25/1986|||APPR|
P790020|S032|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|09/06/1985|03/04/1986|||APPR|
P790020|S033|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|11/25/1985|12/20/1985|||APPR|
P790020|S034|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|||N|04/02/1986|08/04/1986|||APPR|
P790020|S035|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Normal 180 Day Track|Other Report|N|01/20/1987|10/07/1987|||APPR|
P790020|S036|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|THIRTY DAY TRACK|Other Report|N|02/17/1987|08/10/1987|||APPR|
P790020|S037|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Normal 180 Day Track|Other Report|N|07/02/1987|08/29/1990|||APPR|
P790020|S038|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Normal 180 Day Track|Other Report|N|03/14/1988|08/22/1988|||APPR|
P790020|S039|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/1988|09/23/1988|||APPR|
P790020|S040|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/27/1988|05/25/1988|||APPR|
P790020|S041|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/1988|03/01/1989|||APPR|
P790020|S042|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Panel Track|Other Report|N|05/26/1988|12/16/1988|||APPR|
P790020|S043|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/1988|05/10/1989|||APPR|
P790020|S044|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/1988|08/08/1989|||APPR|
P790020|S046|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SAUFLON(R) PW (LIDOFILCON B)|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1989|06/26/1989|||APPR|
P790020|S047|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SURFILCON A/VASURFILCON A|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/16/1989|09/19/1989|||APPR|
P790020|S049|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SURFILCON A/VASURFILCON A|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/19/1989|11/30/1989|||APPR|
P790020|S050|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|LIDOFILCON A HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/1989|12/11/1989|||APPR|
P790020|S051|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|SURFILCON A/VASURFILCON A|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/1989|12/20/1989|||APPR|
P790020|S053|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|PERMAFLEX(R) NATURALS AND PERMAFLEX(R) UV NATURALS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/1991|05/30/1991|||APPR|
P790020|S054|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|PERMAFLEX(R) NATURALS AND PERMAFLEX(R) UV NATURALS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/1993|12/22/1993|||APPR|
P790023|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|||N|11/06/1981|03/03/1982|||APPR|
P790023|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|||N|11/06/1981|03/03/1982|||APPR|
P790023|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|||N|04/12/1982|05/26/1982|||APPR|
P790023|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|||N|07/19/1982|12/30/1982|||APPR|
P790023|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|||N|11/01/1982|08/06/1985|||APPR|
P790023|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|||N|05/23/1983|08/03/1983|||APPR|
P790023|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|||N|04/23/1984|11/29/1984|||APPR|
P790023|S009|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|||N|06/04/1984|11/29/1984|||APPR|
P790023|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1987|05/05/1987|||APPR|
P790023|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
P790023|S012|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSOAK|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
P790024|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|03/11/1981|07/07/1981|||APPR|
P790024|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|04/20/1982|05/21/1982|||APPR|
P790024|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|04/20/1982|07/21/1982|||APPR|
P790024|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SORBI-CARE(TM) DAILY LENS CLEANER|LPN|OP|||N|04/29/1982|12/18/1984|||APPR|
P790024|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|10/01/1982|11/18/1982|||APPR|
P790024|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|04/23/1984|11/29/1984|||APPR|
P790024|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|06/04/1984|11/29/1984|||APPR|
P790024|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|08/08/1984|10/31/1986|||APPR|
P790024|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|08/27/1984|06/07/1985|||APPR|
P790024|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|||N|04/23/1985|03/11/1987|||APPR|
P790024|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/1986|08/14/1987|||APPR|
P790024|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|THIRTY DAY TRACK|Other Report|N|12/03/1986|03/20/1987|||APPR|
P790024|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/1987|07/28/1987|||APPR|
P790024|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 DAILY CONTACT LENS CLEANER|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1987|04/27/1987|||APPR|
P790024|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|C-65 DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/1987|12/30/1987|||APPR|
P790024|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|C-65 DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
P790024|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|C-65 DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/1988|09/22/1988|||APPR|
P790024|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|C-65 DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1989|08/17/1989|||APPR|
P790024|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|C-65 DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/03/1989|09/18/1989|||APPR|
P790024|S022|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|C-65 DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
P790024|S023|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 (R) DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/1992|08/11/1993|||APPR|
P790025|S001|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT: 09VA BLDG: AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT HBE DIAGNOSTIC KIT|LOM|MI|Normal 180 Day Track||N|08/08/1980|10/22/1980|||APPR|
P790025|S002|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT: 09VA BLDG: AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|HBE RIA DIAGNOSTIC KIT|LOM|MI|Normal 180 Day Track||N|03/12/1981|07/02/1981|||APPR|
P790025|S004|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT: 09VA BLDG: AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT HBE DIAGNOSTIC KIT|LOM|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1986|11/14/1986|||APPR|
P790027|S001|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOL|HQL|OP|||N|10/26/1979|10/01/1982|||APPR|
P790027|S002|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|02/25/1982|06/10/1982|||APPR|
P790027|S003|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|06/11/1982|09/14/1982|||APPR|
P790027|S004|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|09/09/1982|03/13/1985|||APPR|
P790027|S005|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|02/10/1983|05/31/1985|||APPR|
P790027|S006|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|03/22/1983|04/26/1983|||APPR|
P790027|S007|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|05/19/1983|03/13/1985|||APPR|
P790027|S008|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|05/31/1983|03/13/1985|||APPR|
P790027|S009|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|06/06/1983|05/17/1985|||APPR|
P790027|S011|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|02/27/1984|05/17/1985|||APPR|
P790027|S013|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|10/02/1984|08/08/1985|||APPR|
P790027|S014|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|11/06/1984|09/05/1985|||APPR|
P790027|S015|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|12/18/1984|08/08/1985|||APPR|
P790027|S016|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|03/07/1985|07/23/1985|||APPR|
P790027|S017|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|06/07/1985|01/22/1986|||APPR|
P790027|S018|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|06/18/1985|10/30/1985|||APPR|
P790027|S019|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|08/21/1985|05/30/1986|||APPR|
P790027|S020|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|01/30/1986|02/21/1986|||APPR|
P790027|S021|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|||N|11/12/1985|06/05/1986|||APPR|
P790027|S022|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/25/1986|11/03/1986|||APPR|
P790027|S023|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Other Report|N|08/04/1986|09/26/1986|||APPR|
P790027|S024|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/1986|11/10/1986|||APPR|
P790027|S025|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/1986|02/11/1987|||APPR|
P790027|S027|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/04/1987|10/16/1987|||APPR|
P790027|S028|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1987|12/07/1987|||APPR|
P790027|S029|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Panel Track|Other Report|N|07/14/1987|09/30/1988|88M-0353|11/30/1988|APPR|
P790027|S030|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1987|02/08/1988|||APPR|
P790027|S032|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/1988|05/09/1988|||APPR|
P790027|S033|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1988|03/17/1989|||APPR|
P790027|S034|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|04/18/1988|08/18/1989|89M-0353|04/05/1990|APPR|
P790027|S035|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/1988|03/02/1989|||APPR|
P790027|S037|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/22/1988|10/03/1988|||APPR|
P790027|S038|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS 101, 101B, 101T|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1988|12/22/1989|||APPR|
P790027|S040|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS G187G, G786B, G787B|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1988|12/13/1989|||APPR|
P790027|S041|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS G187G, G786B, G787B|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1988|11/20/1989|||APPR|
P790027|S043|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS G187G, G786B, G787B|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1988|06/22/1990|||APPR|
P790027|S046|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS G187G, G786B, G787B|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1989|03/19/1990|||APPR|
P790027|S047|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS G187G, G786B, G787B|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1989|03/19/1990|||APPR|
P790027|S050|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS G187G, G786B, G787B|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1989|12/11/1989|||APPR|
P790027|S051|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS G187G, G786B, G787B|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1989|12/13/1989|||APPR|
P790027|S052|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHAMBER LENS MODELS G187G, G786B, G787B|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1989|12/27/1989|||APPR|
P790027|S054|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|VIOLET MONOFILAMENT HAPTICS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1990|07/20/1990|||APPR|
P790027|S055|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|ONE PIECE POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/1990|06/15/1990|||APPR|
P790027|S056|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL 3091B IOL /W 5.0 MM OPTICS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/1992|11/17/1993|||APPR|
P790028|S001|BAYER HEALTHCARE|430 South Beiger Street||MISHAWAKA|IN|46544||CONTROLLER, CLOSED-LOOP BLOOD GLUCOSE|BIOSTATOR GCIIS|LHE|HO|||N|10/04/1982|11/18/1982|||APPR|
P790028|S002|BAYER HEALTHCARE|430 South Beiger Street||MISHAWAKA|IN|46544||CONTROLLER, CLOSED-LOOP BLOOD GLUCOSE|BIOSTATOR GCIIS|LHE|HO|||N|04/21/1983|08/08/1983|||APPR|
P790029|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|06/22/1981|03/17/1982|||APPR|
P790029|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|02/01/1983|08/04/1983|||APPR|
P790029|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|04/01/1983|07/05/1983|||APPR|
P790029|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) DISINFECTING SOLUTION|LPN|OP|||N|09/12/1983|02/08/1984|||APPR|
P790029|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|11/01/1983|05/01/1984|||APPR|
P790029|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|04/08/1985|12/31/1985|||APPR|
P790029|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|08/12/1985|01/10/1986|||APPR|
P790029|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|08/12/1985|12/31/1985|||APPR|
P790029|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|01/21/1986|04/16/1986|||APPR|
P790029|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|||N|03/24/1986|05/28/1986|||APPR|
P790029|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/1986|10/27/1986|||APPR|
P790029|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/1986|01/09/1987|||APPR|
P790029|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1986|12/01/1986|||APPR|
P790029|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|THIRTY DAY TRACK|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/1986|12/04/1986|||APPR|
P790029|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/1987|03/26/1987|||APPR|
P790029|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/30/1987|07/27/1988|||APPR|
P790029|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/1989|11/07/1989|||APPR|
P790029|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/1989|11/21/1989|||APPR|
P790029|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/1990|05/28/1991|||APPR|
P790029|S023|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1990|04/13/1994|||APPR|
P790032|S001|INCSTAR CORP.|1990 INSUSTRIAL BLVD.|P.O. BOX 285|STILLWATER|MN|55082|0285|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|GAMMA DAB (125I) AFP RIA KIT|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/10/1986|08/22/1986|||APPR|
P790032|S002|INCSTAR CORP.|1990 INSUSTRIAL BLVD.|P.O. BOX 285|STILLWATER|MN|55082|0285|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]|LOK|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/1990|03/28/1991|||APPR|
P790032|S003|INCSTAR CORP.|1990 INSUSTRIAL BLVD.|P.O. BOX 285|STILLWATER|MN|55082|0285|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]|LOK|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/1991|07/23/1993|||APPR|
P800001|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|COMBIFLEX|LPN|OP|||N|03/23/1982|04/26/1982|||APPR|
P800002|S001|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE(R) NON-WOVEN WEB|LMF|SU|||N|04/09/1981|06/12/1981|||APPR|
P800002|S002|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB|LMF|SU|||N|01/27/1981|12/18/1981|||APPR|
P800002|S003|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB|LMF|SU|||N|01/07/1982|01/28/1982|||APPR|
P800002|S004|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB|LMF|SU|||N|08/30/1983|01/17/1984|||APPR|
P800002|S005|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB|LMF|SU|||N|10/11/1983|11/17/1983|||APPR|
P800002|S007|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1988|06/01/1988|||APPR|
P800002|S008|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB|LMF|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1991|01/07/1992|||APPR|
P800002|S009|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1992|04/09/1993|||APPR|
P800002|S010|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/1993|09/09/1994|||APPR|
P800003|S001|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||MONITOR, LUNG WATER MEASUREMENT|MODEL 9310 LUNG WATER COMPUTER|JEZ|AN|||N|03/17/1981|06/12/1981|||APPR|
P800005|S001|Abbott Laboratories|.||NORTH CHICAGO|IL|60064||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-RIA DIAGNOSTIC TEST KIT|DHX|IM|||N|02/10/1981|03/06/1981|||APPR|
P800005|S002|Abbott Laboratories|.||NORTH CHICAGO|IL|60064||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA|DHX|IM|||N|02/10/1981|03/06/1981|||APPR|
P800005|S003|Abbott Laboratories|.||NORTH CHICAGO|IL|60064||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA|DHX|IM|||N|07/02/1981|08/11/1981|||APPR|
P800005|S004|Abbott Laboratories|.||NORTH CHICAGO|IL|60064||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA|DHX|IM|||N|03/02/1982|03/29/1982|||APPR|
P800011|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES|LPL|OP|||N|10/27/1980|04/14/1981|||APPR|
P800011|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES|LPL|OP|||N|09/14/1981|12/02/1982|||APPR|
P800011|S005|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES|LPL|OP|||N|05/27/1982|11/23/1982|||APPR|
P800011|S006|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES|LPL|OP|||N|01/30/1984|07/16/1984|||APPR|
P800011|S007|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES|LPL|OP|||N|10/30/1985|12/31/1985|||APPR|
P800011|S008|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/1987|10/19/1988|||APPR|
P800011|S009|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|05/10/1988|||APPR|
P800011|S010|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/1989|12/19/1989|||APPR|
P800012|S002|OSMED, INC.|325 LAKE AVE. SOUTH - SUITE|#608|DULUTH|MN|55802||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|DRILAC{TM} CUBES|LPG|DE|Normal 180 Day Track|Other Report|N|12/17/1984|01/29/1987|||APPR|
P800012|S004|OSMED, INC.|325 LAKE AVE. SOUTH - SUITE|#608|DULUTH|MN|55802||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|DRILAC{TM} CUBES|LPG|DE|Normal 180 Day Track|Other Report|N|08/14/1986|12/22/1986|||APPR|
P800012|S006|OSMED, INC.|325 LAKE AVE. SOUTH - SUITE|#608|DULUTH|MN|55802||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|DRILAC{TM} CUBES / GRANULES|LPG|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/1993|06/28/1994|||APPR|
P800013|S001|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES|LPL|OP|||N|04/09/1981|02/05/1982|||APPR|
P800013|S002|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES|LPL|OP|||N|08/13/1981|09/23/1981|||APPR|
P800016|S001|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|TENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|||N|03/23/1983|05/25/1983|||APPR|
P800016|S003|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|TENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|||N|12/20/1983|06/28/1985|||APPR|
P800016|S005|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|TENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|||N|03/08/1985|07/25/1985|||APPR|
P800016|S006|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|TENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|||N|12/10/1985|01/08/1986|||APPR|
P800016|S007|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|TENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|||N|04/16/1986|06/13/1986|||APPR|
P800016|S011|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|TENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/1988|05/09/1988|||APPR|
P800016|S012|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|TENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/1988|03/02/1989|||APPR|
P800016|S013|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|TENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1989|03/19/1990|||APPR|
P800016|S014|Bausch & Lomb, Inc.|1400 North Goodman Street||Rochester|NY|14609||TRANSDUCER, ULTRASONIC, OBSTETRIC|YENNANT(TM) & KELMAN(TM) TYPE II|HGL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/1989|12/11/1989|||APPR|
P800017|S002|STORZ OPHTHALMICS, INC.|1365 HAMLET AVE.|P.O. 2498|CLEARWATER|FL|34616||intraocular lens|CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS|HQL|OP|||N|02/19/1985|08/08/1985|||APPR|
P800017|S003|STORZ OPHTHALMICS, INC.|1365 HAMLET AVE.|P.O. 2498|CLEARWATER|FL|34616||intraocular lens|CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1987|09/21/1987|||APPR|
P800017|S004|STORZ OPHTHALMICS, INC.|1365 HAMLET AVE.|P.O. 2498|CLEARWATER|FL|34616||intraocular lens|CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/30/1987|01/27/1988|||APPR|
P800018|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|||N|04/13/1982|02/17/1983|||APPR|
P800018|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|||N|10/05/1982|01/25/1983|||APPR|
P800018|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|||N|12/20/1982|08/04/1983|||APPR|
P800018|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|||N|05/27/1983|10/03/1983|||APPR|
P800018|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|||N|01/02/1985|12/31/1985|||APPR|
P800018|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|||N|08/12/1985|12/31/1985|||APPR|
P800018|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/1986|10/27/1986|||APPR|
P800018|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1986|12/01/1986|||APPR|
P800018|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/1987|03/26/1987|||APPR|
P800018|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/1987|03/21/1988|||APPR|
P800018|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/30/1987|07/27/1988|||APPR|
P800018|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/06/1989|06/19/1989|||APPR|
P800018|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/1989|11/21/1989|||APPR|
P800018|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1990|06/05/1990|||APPR|
P800018|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/1990|05/28/1991|||APPR|
P800018|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1990|04/13/1994|||APPR|
P800018|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/1992|03/25/1993|||APPR|
P800019|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|04/24/1981|06/12/1981|||APPR|
P800019|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|07/28/1981|10/26/1981|||APPR|
P800019|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|09/14/1981|12/24/1981|||APPR|
P800019|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|09/14/1981|01/08/1982|||APPR|
P800019|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|01/13/1982|06/01/1982|||APPR|
P800019|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|05/20/1982|06/25/1982|||APPR|
P800019|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|06/20/1985|07/29/1985|||APPR|
P800019|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|||N|06/20/1985|08/29/1985|||APPR|
P800019|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH IV UNIPOLAR PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Other Report|N|09/15/1989|02/16/1990|||APPR|
P800020|S001|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|SILSOFT (ELASTOFILCON A) CONTACT LENS|LPL|OP|||N|08/29/1980|09/01/1981|||APPR|
P800020|S002|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|SILSOFT (ELASTOFILCON A ) CONTACT LENS|LPL|OP|||N|07/23/1981|02/26/1982|||APPR|
P800020|S003|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|SILSOFT (ELASTOFILCON A ) CONTACT LENS|LPL|OP|||N|06/04/1982|09/02/1982|||APPR|
P800020|S004|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|SILSOFT (ELASTOFILCON A ) CONTACT LENS|LPL|OP|||N|06/04/1982|03/11/1983|||APPR|
P800020|S005|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|SILSOFT (ELASTOFILCON A ) CONTACT LENS|LPL|OP|||N|09/10/1982|11/23/1982|||APPR|
P800020|S006|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|SILSOFT (ELASTOFILCON A ) CONTACT LENS|LPL|OP|||N|03/29/1983|05/03/1983|||APPR|
P800020|S007|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 1767||MIDLAND|MI|48640||Lenses, soft contact, daily wear|SILSOFT (ELASTOFILCON A ) CONTACT LENS|LPL|OP|||N|08/28/1985|11/05/1985|||APPR|
P800022|S001|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|10/21/1981|11/19/1981|||APPR|
P800022|S002|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|10/27/1981|11/20/1981|||APPR|
P800022|S003|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|10/08/1982|10/26/1982|||APPR|
P800022|S004|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|11/30/1982|03/02/1983|||APPR|
P800022|S005|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|03/16/1983|08/18/1983|||APPR|
P800022|S006|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|02/25/1983|04/07/1983|||APPR|
P800022|S007|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|04/19/1983|06/08/1984|||APPR|
P800022|S008|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|07/20/1983|02/23/1984|||APPR|
P800022|S009|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|||N|06/18/1984|07/26/1984|||APPR|
P800022|S011|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R)|LMH|SU|||N|10/25/1984|06/24/1985|||APPR|
P800022|S013|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|IMPLANT, COLLAGEN FOR NON-AESTHETIC USE|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMI|SU|||N|08/26/1985|11/22/1985|||APPR|
P800022|S015|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/1988|11/22/1988|||APPR|
P800022|S016|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/08/1988|02/08/1991|||APPR|
P800022|S017|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/1989|04/13/1990|||APPR|
P800022|S018|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1989|07/17/1990|||APPR|
P800022|S020|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/1990|02/20/1990|||APPR|
P800022|S021|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/1990|10/12/1990|||APPR|
P800022|S022|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/1990|06/07/1991|||APPR|
P800022|S023|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/1991|06/16/1995|||APPR|
P800022|S025|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1991|09/30/1991|||APPR|
P800022|S027|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/04/1991|12/16/1991|||APPR|
P800022|S028|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM COLLAGEN IMPLANT (ZYDERM CI)|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/16/1991|01/08/1992|||APPR|
P800022|S029|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1991|12/16/1991|||APPR|
P800022|S030|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1991|12/06/1991|||APPR|
P800022|S032|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/1991|07/07/1992|||APPR|
P800022|S033|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) COLLAGEN IMPLANT (3.0 CC SYRINGE)|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1992|07/27/1992|||APPR|
P800022|S034|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) COLLAGEN IMPLANT|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/1992|07/07/1992|||APPR|
P800022|S035|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Other Report|N|03/20/1992|04/17/1995|||APPR|
P800022|S036|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R)COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/1992|09/02/1992|||APPR|
P800022|S038|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R)COL.IMPLANT/DEAERATING|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/1992|04/12/1993|||APPR|
P800022|S039|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R)COL.IMP./QUAL.CON.CHANGE|LMH|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/1992|09/30/1993|||APPR|
P800022|S040|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/1993|11/01/1993|||APPR|
P800022|S041|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/1993|11/01/1993|||APPR|
P800022|S042|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1992|05/13/1993|||APPR|
P800022|S044|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1993|11/01/1993|||APPR|
P800022|S045|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/11/1994|11/14/1994|||APPR|
P800022|S046|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/20/1994|05/24/1995|||APPR|
P800024|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLUTION|LPN|OP|||N|10/08/1980|07/31/1981|||APPR|
P800024|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|02/26/1981|09/01/1981|||APPR|
P800024|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|08/11/1981|09/22/1981|||APPR|
P800024|S004|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|08/09/1982|10/21/1982|||APPR|
P800024|S006|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|02/28/1983|08/12/1983|||APPR|
P800024|S007|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|04/01/1983|08/24/1983|||APPR|
P800024|S008|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|07/25/1983|04/19/1985|||APPR|
P800024|S009|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|09/01/1983|03/19/1984|||APPR|
P800024|S010|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|12/08/1983|09/25/1984|||APPR|
P800024|S011|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|02/08/1984|01/29/1985|||APPR|
P800024|S012|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|||N|03/04/1985|03/19/1987|||APPR|
P800024|S013|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1987|06/22/1987|||APPR|
P800024|S014|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1988|07/06/1988|||APPR|
P800024|S015|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB STERILE PRESERVED SALINE SOLN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/1988|11/21/1988|||APPR|
P800024|S016|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB RENEW (R) SALINE SOLN. (BL-101-BEU13|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1990|02/28/1991|||APPR|
P800025|S001|Bio-Rad Laboratories, Inc.|3 Boulevard Raymond Poincare'||Marnes-la-Coquette||92430||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AFP/OB(TM) RIA KIT|LOK|IM|||N|01/26/1984|02/22/1984|||APPR|
P800025|S003|Bio-Rad Laboratories, Inc.|3 Boulevard Raymond Poincare'||Marnes-la-Coquette||92430||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|QUANTITOPE 125I AFP KIT AND CONTROL SERUM|LOK|IM|||N|04/01/1985|07/17/1985|||APPR|
P800025|S004|Bio-Rad Laboratories, Inc.|3 Boulevard Raymond Poincare'||Marnes-la-Coquette||92430||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|QUANTITOPE 125I AFP KIT AND CONTROL SERUM|LOK|IM|||N|03/18/1986|04/21/1988|||APPR|
P800026|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|||N|06/20/1985|08/26/1986|||APPR|
P800026|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|||N|01/08/1986|03/21/1986|||APPR|
P800026|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/05/1987|07/23/1987|||APPR|
P800026|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/1988|06/16/1988|||APPR|
P800026|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1988|01/10/1989|||APPR|
P800026|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/1988|06/26/1989|||APPR|
P800026|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/1989|08/30/1989|||APPR|
P800026|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P800028|S001|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|06/18/1981|07/27/1981|||APPR|
P800028|S002|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|06/04/1981|07/27/1981|||APPR|
P800028|S003|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|10/27/1981|10/01/1982||02/18/1983|APPR|
P800028|S004|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|04/22/1982|05/11/1982|||APPR|
P800028|S005|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|05/11/1982|07/30/1982|||APPR|
P800028|S006|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|06/01/1982|07/30/1982|||APPR|
P800028|S007|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|08/04/1982|09/14/1982|||APPR|
P800028|S008|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|11/16/1983|01/26/1984|||APPR|
P800028|S009|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|11/15/1983|03/22/1984|||APPR|
P800028|S010|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|12/21/1983|05/25/1984|||APPR|
P800028|S011|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|03/02/1984|05/11/1984|||APPR|
P800028|S012|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|08/09/1984|05/15/1985|||APPR|
P800028|S013|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|||N|11/05/1985|01/22/1986|||APPR|
P800028|S014|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/1987|05/19/1987|||APPR|
P800028|S015|BLAIREX LABORATORIES, INC.|4810 TECUMSEH LN,|P.O. BOX 15190|EVANSVILLE|IN|47716|0190|Accessories, soft lens products|THE BLAIREX SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/1987|11/20/1987|||APPR|
P800029|S001|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS|LON|MI|||N|02/12/1981|02/24/1981|||APPR|
P800029|S002|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS|LON|MI|||N|06/19/1981|07/27/1981|||APPR|
P800029|S003|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM|LON|MI|||N|05/12/1982|06/18/1982|||APPR|
P800029|S005|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|OMNISCEPT(TM) KB SYSTEM|LON|MI|||N|12/03/1982|07/05/1983|||APPR|
P800029|S007|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM|LON|MI|||N|06/28/1983|11/25/1983|||APPR|
P800029|S008|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM|LON|MI|||N|08/23/1983|11/17/1983|||APPR|
P800029|S009|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM|LON|MI|||N|04/05/1984|04/24/1984|||APPR|
P800029|S010|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM|LON|MI|||N|04/17/1984|05/04/1984|||APPR|
P800030|S001|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|1875 EYE ST. NW STE. 625||WASHINGTON|DC|20006||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC|LON|MI|||N|06/08/1981|08/26/1981|||APPR|
P800030|S002|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|1875 EYE ST. NW STE. 625||WASHINGTON|DC|20006||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC|LON|MI|||N|10/13/1982|03/01/1983|||APPR|
P800030|S003|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|1875 EYE ST. NW STE. 625||WASHINGTON|DC|20006||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC|LON|MI|||N|10/04/1982|01/24/1983|||APPR|
P800030|S004|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|1875 EYE ST. NW STE. 625||WASHINGTON|DC|20006||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC|LON|MI|||N|01/07/1983|04/28/1983|||APPR|
P800030|S005|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|1875 EYE ST. NW STE. 625||WASHINGTON|DC|20006||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC|LON|MI|||N|01/19/1983|06/03/1983|||APPR|
P800030|S006|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|1875 EYE ST. NW STE. 625||WASHINGTON|DC|20006||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC|LON|MI|||N|02/08/1984|11/05/1984|||APPR|
P800031|S001|N&N MENICON, INC.|4201 198TH S.W. #1035||LYNNWOOD|WA|98036||Lenses, soft contact, daily wear|(MAFILCON) SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/1988|05/05/1989|||APPR|
P800032|S001|MILES LABORATORIES, INC.|1127 MYRTLE ST.|P.O. BOX 40|ELKHART|IN|46514||CONTROLLER, CLOSED-LOOP BLOOD GLUCOSE|BIOSTATOR GLUCOSE CONTROLLER|LHE|HO|||N|04/28/1983|06/02/1983|||APPR|
P800034|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|||N|05/24/1982|07/16/1982|||APPR|
P800034|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|||N|10/19/1982|07/05/1983|||APPR|
P800034|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|||N|07/12/1983|10/18/1983|||APPR|
P800034|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|||N|01/20/1984|10/30/1985|||APPR|
P800034|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|||N|06/20/1985|08/26/1986|||APPR|
P800034|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|||N|01/08/1986|03/21/1986|||APPR|
P800034|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|Normal 180 Day Track|Other Report|N|10/01/1986|05/12/1987|||APPR|
P800034|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/1987|07/28/1987|||APPR|
P800034|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/1988|06/27/1988|||APPR|
P800034|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/1988|08/09/1988|||APPR|
P800034|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1988|06/22/1989|||APPR|
P800034|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|8LERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/1989|08/30/1989|||APPR|
P800034|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|8LERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P800035|S001|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|IMPLANT, ENDOSSEOUS, ROOT-FORM|SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)|DZE|DE|||N|12/14/1981|03/12/1982|||APPR|
P800035|S002|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|IMPLANT, ENDOSSEOUS, ROOT-FORM|SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)|DZE|DE|||N|06/30/1982|07/16/1982|||APPR|
P800035|S003|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|IMPLANT, ENDOSSEOUS, ROOT-FORM|SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)|DZE|DE|||N|10/22/1982|11/08/1982|||APPR|
P800035|S004|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|IMPLANT, ENDOSSEOUS, ROOT-FORM|SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)|DZE|DE|||N|12/20/1982|06/07/1983|||APPR|
P800035|S005|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|IMPLANT, ENDOSSEOUS, ROOT-FORM|SYNTHOGRAFT(TM) LARGE GRANULAR (LG)|DZE|DE|||N|06/15/1982|08/09/1982|||APPR|
P800035|S007|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|IMPLANT, ENDOSSEOUS, ROOT-FORM|SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)|DZE|DE|||N|09/13/1983|08/07/1984|||APPR|
P800035|S008|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|IMPLANT, ENDOSSEOUS, ROOT-FORM|AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG|DZE|DE|||N|10/11/1983|11/10/1983|||APPR|
P800036|S001|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/10/1982|06/23/1982|||APPR|
P800036|S002|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|07/12/1982|02/25/1983|||APPR|
P800036|S003|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|02/22/1983|06/02/1983|||APPR|
P800036|S004|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|02/22/1983|07/05/1983|||APPR|
P800036|S005|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|06/22/1983|06/04/1984|||APPR|
P800036|S006|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|08/26/1983|10/30/1985|||APPR|
P800036|S007|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|01/31/1984|09/30/1985|||APPR|
P800036|S008|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|05/03/1984|08/06/1986|||APPR|
P800036|S009|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|05/07/1984|10/30/1985|||APPR|
P800036|S011|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|09/20/1984|06/19/1986|||APPR|
P800036|S012|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|||N|09/12/1984|11/12/1985|||APPR|
P800036|S013|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/1985|11/04/1988|82M-0072|02/01/1989|APPR|
P800036|S015|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/16/1987|09/20/1995|||APPR|APPROVAL FOR CHANGE IN LABELING TO INCLUDE EPIDURAL AND INTRATHECAL ADMINISTRATION OF INFUMORPH 200 & 500 CII (PRESERVATIVE-FREE MORPHINE) IN PATIENTS SUFFERING FROM SEVERE AND PROLONGED PAIN WHO ARE NO  LONGER RESPONSIVE TO CONVENTIONAL FORMS OF ANALGESIA
P800036|S016|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1987|03/22/1988|||APPR|
P800036|S018|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/28/1988|08/08/1989|||APPR|
P800036|S019|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/23/1989|08/10/1989|||APPR|
P800036|S021|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|NFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4|LKK|HO|Normal 180 Day Track||N|06/12/1989|10/18/1989|||APPR|
P800036|S024|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID REFILL KIT|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/29/1990|10/19/1990|||APPR|
P800036|S025|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID REFILL KIT|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1990|10/19/1990|||APPR|
P800036|S029|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/1992|06/17/1993|||APPR|
P800036|S030|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/29/1993|08/14/1995|||APPR|APPROVAL FOR LABELING CHANGE
P800036|S031|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/1994|12/23/1996|||APPR|APPROVAL FOR THE UNFUSAID(TM) 14G INTRASPINAL CATHETER KIT, AN ACCESSORY TO THE INFUSAID IMPLANTABLE INFUSION PUMP.
P800038|S001|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|05/14/1982|10/04/1982||02/18/1983|APPR|
P800038|S002|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|05/23/1983|08/12/1983|||APPR|
P800038|S003|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|09/22/1983|03/01/1984|||APPR|
P800038|S004|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|10/28/1983|02/23/1984|||APPR|
P800038|S005|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|06/26/1984|05/15/1985|||APPR|
P800038|S006|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|09/10/1984|05/21/1985|||APPR|
P800038|S007|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|04/15/1985|10/03/1985|||APPR|
P800038|S008|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|06/24/1985|12/16/1985|||APPR|
P800038|S009|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|||N|04/01/1986|06/09/1986|||APPR|
P800038|S010|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/1987|02/04/1988|||APPR|
P800038|S011|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/1987|05/05/1988|||APPR|
P800038|S012|MARLIN INDUSTRIES|P.O. BOX 284||TARZANA|CA|91356||Accessories, soft lens products|MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/1989|11/22/1989|||APPR|
P800040|S001|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|||N|06/23/1981|10/26/1981|||APPR|
P800040|S002|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|||N|08/03/1981|03/01/1982|||APPR|
P800040|S003|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|||N|03/17/1982|04/02/1982|||APPR|
P800040|S004|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|||N|04/26/1982|07/22/1982|||APPR|
P800040|S005|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|||N|11/16/1983|03/08/1984|||APPR|
P800040|S006|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|||N|03/16/1984|05/21/1984|||APPR|
P800040|S007|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|||N|07/09/1984|06/13/1985|||APPR|
P800040|S008|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1986|08/20/1986|||APPR|
P800040|S009|CORDIS CORP.|PO BOX 525700||MIAMI|FL|33152||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/1987|03/22/1988|||APPR|
P800041|S001|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP|DTB|CV|Normal 180 Day Track|Other Report|N|12/17/1982|01/27/1983|||APPR|
P800041|S002|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP|DTB|CV|||N|08/18/1983|09/20/1983|||APPR|
P800041|S003|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP|DTB|CV|||N|11/19/1984|04/12/1985|||APPR|
P800041|S005|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP|DTB|CV|||N|10/17/1985|02/12/1986|||APPR|
P800041|S006|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP|DTB|CV|Normal 180 Day Track|Other Report|N|08/12/1986|09/02/1986|||APPR|
P800041|S007|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/1987|06/22/1987|||APPR|
P800041|S008|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/1989|06/19/1989|||APPR|
P800041|S009|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1990|12/10/1990|||APPR|
P800041|S010|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K|DTB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/1990|12/18/1990|||APPR|
P800041|S011|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/1991|05/25/1994|||APPR|
P800041|S012|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|CARBON TIPPED LEAD ALT.PROD.TRAYS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|11/18/1992|||APPR|
P800041|S014|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|CARBON TIP CARDIAC PACING LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/26/1993|10/17/1994|||APPR|
P800043|S001|RADIOMETER AMERICA, INC.|811 SHARON DR.||WESTLAKE|OH|44145||MONITOR, CARBON-DIOXIDE, CUTANEOUS|RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO|LKD|AN|||N|08/25/1981|09/21/1981|||APPR|
P800043|S002|RADIOMETER AMERICA, INC.|811 SHARON DR.||WESTLAKE|OH|44145||MONITOR, CARBON-DIOXIDE, CUTANEOUS|RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO|LKD|AN|||N|05/10/1982|03/01/1984||04/13/1984|APPR|
P800043|S003|RADIOMETER AMERICA, INC.|811 SHARON DR.||WESTLAKE|OH|44145||MONITOR, CARBON-DIOXIDE, CUTANEOUS|RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO|LKD|AN|||N|09/04/1984|02/22/1985|||APPR|
P800043|S004|RADIOMETER AMERICA, INC.|811 SHARON DR.||WESTLAKE|OH|44145||MONITOR, CARBON-DIOXIDE, CUTANEOUS|RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO|LKD|AN|||N|07/09/1984|02/21/1986|||APPR|
P800049|S001|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODELS 1S & 1P|HQL|OP|||N|07/12/1983|05/09/1985|||APPR|
P800049|S003|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODELS 1S & 1P|HQL|OP|||N|04/30/1985|10/01/1985|||APPR|
P800049|S004|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODELS 1S & 1P|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/1991|05/29/1992|||APPR|
P800049|S005|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P800054|S001|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|08/13/1981|03/17/1982|||APPR|
P800054|S002|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|10/29/1981|02/16/1982|||APPR|
P800054|S003|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|01/05/1982|02/12/1982|||APPR|
P800054|S004|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|11/22/1982|11/09/1983||12/12/1983|APPR|
P800054|S005|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|12/27/1982|05/16/1983|||APPR|
P800054|S006|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|03/31/1983|05/03/1983|||APPR|
P800054|S007|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|09/13/1983|11/01/1983|||APPR|
P800054|S008|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|10/06/1983|10/31/1984|||APPR|
P800054|S009|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|11/30/1983|03/12/1984|||APPR|
P800054|S010|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|P.O. BOX 2693||NORFOLK|VA|23501||Lenses, soft contact, daily wear|SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR|LPL|OP|||N|05/08/1985|11/18/1985|||APPR|
P800055|S001|APOTHECARY PRODUCTS, INC.|BURNSVILLE MN||BURNSVILLE|MN|55337||Accessories, soft lens products|THE NORMALINE KIT|LPN|OP|||N|01/15/1982|02/05/1982|||APPR|
P800055|S002|APOTHECARY PRODUCTS, INC.|BURNSVILLE MN||BURNSVILLE|MN|55337||Accessories, soft lens products|THE NORMALINE KIT|LPN|OP|||N|09/15/1982|05/27/1983||06/17/1983|APPR|
P800056|S001|Abbott Laboratories|.||NORTH CHICAGO|IL|60064||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA--RIA DIXGNOSTIC TEST KIT|DHX|IM|||N|12/31/1980|03/11/1981|||APPR|
P800056|S002|Abbott Laboratories|.||NORTH CHICAGO|IL|60064||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-EIA DIAGNOSTIC TEST KIT|DHX|IM|||N|02/10/1981|03/06/1981|||APPR|
P800056|S003|Abbott Laboratories|.||NORTH CHICAGO|IL|60064||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT CEA-EIA TEST KIT|DHX|IM|||N|07/13/1981|03/03/1982|||APPR|
P800058|S001|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|N.C.G.T. GRAFT|LXA|CV|||N|08/11/1982|07/20/1987|||APPR|
P800058|S003|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|N.C.G.T. GRAFT|LXA|CV|||N|03/06/1986|07/11/1986|||APPR|
P800058|S005|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|N.C.G.T. GRAFT|LXA|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1986|07/30/1987|||APPR|
P800058|S006|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|N.C.G.T. GRAFT|LXA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/1986|06/14/1988|||APPR|
P800058|S007|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|N.C.G.T. GRAFT|LXA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/1986|11/02/1987|||APPR|
P800058|S008|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|N.C.G.T. GRAFT|LXA|CV|Normal 180 Day Track|Other Report|N|09/09/1988|01/19/1989|||APPR|
P800058|S011|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|N.C.G.T. GRAFT|LXA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1990|09/19/1991|||APPR|
P800058|S014|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|BIOPOLYMERIC(TM) VASCULAR GRAFT|LXA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1991|08/29/1991|||APPR|
P800058|S015|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||TISSUE GRAFT OF 6MM AND GREATER|BIOPOLYMERIC(TM) VASCULAR GRAFT|LXA|CV|Normal 180 Day Track|Other Report|N|01/23/1993|10/25/1994|||APPR|
P800060|S001|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|STEVENS POINT|||WI|54481||Accessories, soft lens products|THE SOFT RINSE SYSTEM|LPN|OP|||N|01/15/1982|02/05/1982|||APPR|
P800060|S002|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|STEVENS POINT|||WI|54481||Accessories, soft lens products|SOFT RINSE 250(TM)|LPN|OP|||N|05/24/1982|10/04/1982|||APPR|
P800060|S003|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|STEVENS POINT|||WI|54481||Accessories, soft lens products|THE SOFT RINSE SYSTEM|LPN|OP|||N|08/17/1982|10/21/1982||02/18/1983|APPR|
P800060|S005|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|STEVENS POINT|||WI|54481||Accessories, soft lens products|THE SOFT RINSE SYSTEM|LPN|OP|Normal 180 Day Track||N|09/22/1983|04/04/1984|||APPR|
P800060|S006|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|STEVENS POINT|||WI|54481||Accessories, soft lens products|THE SOFT RINSE SYSTEM|LPN|OP|||N|12/04/1984|07/30/1985|||APPR|
P800060|S007|DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS|STEVENS POINT|||WI|54481||Accessories, soft lens products|THE SOFT RINSE SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/06/1990|03/05/1991|||APPR|
P800061|S001|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN I125|LPJ|CH|||N|10/22/1980|06/02/1981|||APPR|
P800061|S002|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|04/09/1982|05/21/1982|||APPR|
P800061|S003|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|10/18/1982|12/22/1982|||APPR|
P800061|S004|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|10/18/1982|12/22/1982|||APPR|
P800061|S005|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|11/15/1982|01/24/1983|||APPR|
P800061|S006|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|03/26/1984|04/24/1984|||APPR|
P800061|S007|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|06/14/1984|03/26/1985|||APPR|
P800061|S008|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|01/22/1985|03/26/1985|||APPR|
P800061|S009|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|04/15/1985|07/23/1985|||APPR|
P800061|S010|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, ESTROGEN RECEPTOR|RIANEN 3H|LPJ|CH|||N|11/19/1985|01/16/1986|||APPR|
P800063|S001|HOFFMANN-LA ROCHE, INC.|.||NUTLEY|NJ|||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE TEST KIT|DHX|IM|||N|09/11/1981|03/03/1982|||APPR|
P800063|S002|HOFFMANN-LA ROCHE, INC.|.||NUTLEY|NJ|||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE TEST KIT|DHX|IM|||N|08/20/1982|09/16/1982|||APPR|
P800063|S003|HOFFMANN-LA ROCHE, INC.|.||NUTLEY|NJ|||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE TEST KIT|DHX|IM|||N|09/15/1982|10/21/1982|||APPR|
P800063|S004|HOFFMANN-LA ROCHE, INC.|.||NUTLEY|NJ|||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE TEST KIT|DHX|IM|||N|12/15/1982|10/18/1983|||APPR|
P800065|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|TEAR REWETTER|LPN|OP|||N|02/25/1982|07/02/1982|||APPR|
P800065|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|||N|04/20/1982|09/27/1982|||APPR|
P800065|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|||N|12/20/1982|08/04/1983|||APPR|
P800065|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|||N|01/25/1983|08/20/1985|||APPR|
P800065|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|||N|10/12/1983|12/06/1985|||APPR|
P800065|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|||N|04/23/1984|11/29/1984|||APPR|
P800065|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|||N|06/04/1984|11/29/1984|||APPR|
P800065|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/16/1986|02/17/1987|||APPR|
P800065|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/1986|05/18/1987|||APPR|
P800065|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/1988|05/10/1988|||APPR|
P800065|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
P800065|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/1988|11/21/1988|||APPR|
P800065|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
P800069|S001|AMCON, INC.|1102 MAIN ST.|P.O. BOX 176|GRANDVIEW|MO|64030||Accessories, soft lens products|NOR-SA-TAB|LPN|OP|||N|01/15/1982|02/05/1982|||APPR|
P800069|S002|AMCON, INC.|1102 MAIN ST.|P.O. BOX 176|GRANDVIEW|MO|64030||Accessories, soft lens products|THE AMCON WAY PLUS|LPN|OP|||N|05/12/1982|10/05/1982||02/22/1983|APPR|
P800069|S003|AMCON, INC.|1102 MAIN ST.|P.O. BOX 176|GRANDVIEW|MO|64030||Accessories, soft lens products|AMCON DUO|LPN|OP|||N|05/12/1982|02/28/1983|||APPR|
P800069|S004|AMCON, INC.|1102 MAIN ST.|P.O. BOX 176|GRANDVIEW|MO|64030||Accessories, soft lens products|THE AMCON WAY II|LPN|OP|||N|05/12/1982|02/28/1983|||APPR|
P800069|S006|AMCON, INC.|1102 MAIN ST.|P.O. BOX 176|GRANDVIEW|MO|64030||Accessories, soft lens products|NOR-SA-TAB|LPN|OP|||N|04/16/1985|07/31/1985|||APPR|
P800069|S007|AMCON, INC.|1102 MAIN ST.|P.O. BOX 176|GRANDVIEW|MO|64030||Accessories, soft lens products|NOR-SA-TAB|LPN|OP|||N|05/24/1985|08/28/1985|||APPR|
P800069|S008|AMCON, INC.|1102 MAIN ST.|P.O. BOX 176|GRANDVIEW|MO|64030||Accessories, soft lens products|NOR-SA-TAB|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/1986|12/04/1986|||APPR|
P800069|S009|AMCON, INC.|1102 MAIN ST.|P.O. BOX 176|GRANDVIEW|MO|64030||Accessories, soft lens products|87R-SA-TAB|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/1987|07/15/1988|||APPR|
P800070|S001|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT(TM) (DELTAFILCON A)|LPL|OP|||N|12/14/1981|03/01/1982|||APPR|
P800070|S002|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT(TM) (DELTAFILCON A)|LPL|OP|||N|12/16/1982|04/04/1983|||APPR|
P800070|S003|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT(TM) (DELTAFILCON A)|LPL|OP|||N|12/13/1983|06/26/1984|||APPR|
P800070|S004|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT(TM) (DELTAFILCON A)|LPL|OP|||N|11/30/1984|05/20/1985|||APPR|
P810001|S001|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODEL AC (AC1-AC5)|HQL|OP|||N|01/24/1983|01/31/1986|||APPR|
P810001|S002|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODEL AC (AC1-AC5)|HQL|OP|||N|07/12/1983|04/12/1985|||APPR|
P810001|S004|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODEL AC (AC1-AC5)|HQL|OP|||N|04/30/1985|10/01/1985|||APPR|
P810001|S005|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODEL AC (AC1-AC5)|HQL|OP|||N|04/08/1986|09/29/1986|||APPR|
P810001|S006|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODEL AC (AC1-AC5)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1987|11/03/1987|||APPR|
P810001|S007|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODEL AC (AC1-AC5)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1987|05/03/1988|||APPR|
P810001|S008|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|MODEL AC (AC1-AC5)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/1987|05/03/1988|||APPR|
P810001|S010|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P810002|S001|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|||N|02/28/1983|04/27/1983|||APPR|
P810002|S002|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|||N|03/17/1983|07/12/1983|||APPR|
P810002|S003|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|||N|04/11/1983|03/01/1984|||APPR|
P810002|S004|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|||N|01/27/1984|05/16/1984|||APPR|
P810002|S006|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|||N|07/27/1984|01/08/1985|||APPR|
P810002|S008|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Other Report|N|06/14/1986|12/11/1987|||APPR|
P810002|S009|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/1986|11/24/1986|||APPR|
P810002|S010|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/1986|05/02/1991|||APPR|
P810002|S011|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/1986|12/03/1987|||APPR|
P810002|S012|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1986|10/05/1987|||APPR|
P810002|S013|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/04/1987|11/30/1989|||APPR|
P810002|S014|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1987|02/29/1988|||APPR|
P810002|S015|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1987|05/18/1988|||APPR|
P810002|S016|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/31/1987|01/20/1988|||APPR|
P810002|S017|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/25/1988|11/30/1989|||APPR|
P810002|S018|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Other Report|N|06/15/1988|09/30/1991|||APPR|
P810002|S019|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MODEL AT-103(SIZES 19-31MM) & MT-103(SIZES 19-33MM|LWQ|CV|Normal 180 Day Track|Other Report|N|06/26/1990|09/21/1990|||APPR|
P810002|S020|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MODEL AT-103(SIZES 19-31MM) & MT-103(SIZES 19-33MM|LWQ|CV|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/1990|08/29/1991|||APPR|
P810002|S021|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM AORTIC VALVED GRAFT (AVG) PROSTHESIS|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/1991|11/06/1991|||APPR|
P810002|S022|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM AORTIC VALVED GRAFT (AVG) PROSTHESIS|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/20/1991|01/09/1992|||APPR|
P810002|S024|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/17/1992|10/27/1992|||APPR|
P810002|S025|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +|LWQ|CV|Normal 180 Day Track|Other Report|N|01/04/1993|03/31/1994|||APPR|
P810002|S026|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC +|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/1993|09/23/1993|||APPR|
P810002|S027|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MODEL CAVG-404 PROTHESIS|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/15/1993|02/10/1994|||APPR|
P810002|S028|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MODEL CAVG-304 PROTHESIS|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/1994|05/10/1994|||APPR|
P810002|S029|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM PYROLYTIC CARBON|LWQ|CV|Normal 180 Day Track|Other Report|N|03/02/1994|04/08/1994|||APPR|
P810002|S030|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM PYROLYTIC CARBON|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/1994|04/13/1994|||APPR|
P810002|S032|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1994|07/29/1994|||APPR|
P810005|S001|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|10/13/1981|11/29/1982|||APPR|
P810005|S002|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|10/13/1981|06/15/1982||07/27/1982|APPR|
P810005|S003|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|03/26/1982|04/19/1982|||APPR|
P810005|S004|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|10/04/1982|05/04/1983|||APPR|
P810005|S005|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|11/22/1982|02/02/1983|||APPR|
P810005|S006|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|11/22/1982|03/02/1983|||APPR|
P810005|S007|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|04/15/1983|06/07/1983|||APPR|
P810005|S009|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|12/01/1983|01/20/1984|||APPR|
P810005|S010|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|03/13/1984|04/04/1984|||APPR|
P810005|S011|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|04/26/1984|07/18/1984|||APPR|
P810005|S012|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|01/17/1985|05/15/1985|||APPR|
P810005|S013|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|05/07/1985|11/18/1985|||APPR|
P810005|S014|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|07/02/1985|06/07/1988|||APPR|
P810005|S015|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|07/08/1985|11/18/1985|||APPR|
P810005|S016|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|02/04/1986|04/22/1986|||APPR|
P810005|S017|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|02/20/1986|03/31/1987|87M-0124|05/04/1987|APPR|
P810005|S018|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|05/01/1986|07/07/1986|||APPR|
P810005|S020|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1988|07/25/1988|||APPR|
P810005|S021|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1988|01/23/1989|||APPR|
P810005|S022|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/1989|08/08/1989|||APPR|
P810005|S023|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/16/1990|||APPR|
P810005|S024|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/1989|01/31/1990|||APPR|
P810005|S025|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1989|03/21/1991|||APPR|
P810005|S026|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1991|08/06/1991|||APPR|
P810005|S027|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBA OPAQUE(TEFILICON)(HYDROPHILIC) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/1991|12/10/1991|||APPR|
P810006|S001|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|||N|01/27/1982|05/26/1982|||APPR|
P810006|S002|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|||N|02/11/1982|04/12/1982|||APPR|
P810006|S003|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|||N|05/09/1983|11/09/1983|||APPR|
P810006|S005|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|||N|08/19/1983|10/22/1984|||APPR|
P810006|S006|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|||N|05/22/1984|02/04/1985|||APPR|
P810006|S007|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|||N|03/05/1985|05/02/1985|||APPR|
P810006|S008|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|||N|09/06/1985|06/23/1987|||APPR|
P810006|S009|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/1988|04/14/1989|||APPR|
P810006|S011|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/1988|09/26/1989|||APPR|
P810006|S012|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1989|12/19/1989|||APPR|
P810006|S013|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/1991|09/17/1991|||APPR|
P810006|S016|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT HEMO SPONGE CHANGE IN PACKAGING|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1992|11/01/1993|||APPR|
P810006|S017|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT MICROFIBRILLAR HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/1993|05/13/1993|||APPR|
P810006|S018|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/1993|12/21/1993|||APPR|
P810008|S001|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|MIRASOL(TM)|LPN|OP|||N|04/23/1982|07/02/1982|||APPR|
P810008|S002|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|MIRASOL(TM)|LPN|OP|||N|09/29/1982|11/22/1982|||APPR|
P810008|S003|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|MIRASOL(TM)|LPN|OP|||N|10/19/1982|07/01/1983|||APPR|
P810008|S004|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|MIRASOL(TM)|LPN|OP|||N|06/17/1983|08/26/1983|||APPR|
P810008|S006|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Accessories, soft lens products|MIRASOL(TM)|LPN|OP|||N|02/03/1986|06/17/1986|||APPR|
P810009|S001|HORIZON PHARMACAL, INC.|PO BOX 9812||KANSAS CITY|MO|64134||Accessories, soft lens products|THE HORIZON SYSTEM|LPN|OP|||N|01/15/1982|02/05/1982|||APPR|
P810009|S002|HORIZON PHARMACAL, INC.|PO BOX 9812||KANSAS CITY|MO|64134||Accessories, soft lens products|THE HORIZON SYSTEM|LPN|OP|||N|04/06/1982|10/01/1982||02/18/1983|APPR|
P810009|S003|HORIZON PHARMACAL, INC.|PO BOX 9812||KANSAS CITY|MO|64134||Accessories, soft lens products|THE HORIZON SYSTEM|LPN|OP|||N|01/10/1983|05/03/1983|||APPR|
P810009|S004|HORIZON PHARMACAL, INC.|PO BOX 9812||KANSAS CITY|MO|64134||Accessories, soft lens products|THE HORIZON SYSTEM|LPN|OP|||N|08/18/1983|04/04/1984|||APPR|
P810009|S005|HORIZON PHARMACAL, INC.|PO BOX 9812||KANSAS CITY|MO|64134||Accessories, soft lens products|THE HORIZON SYSTEM|LPN|OP|||N|06/22/1984|05/03/1985|||APPR|
P810015|S001|CIBA VISION CARE|2910 AMWILER COURT||ATLANTA|GA|30360||Accessories, soft lens products|SALT TABLETS|LPN|OP|||N|03/01/1982|10/05/1982||02/18/1983|APPR|
P810015|S003|CIBA VISION CARE|2910 AMWILER COURT||ATLANTA|GA|30360||Accessories, soft lens products|SALT TABLETS|LPN|OP|||N|04/30/1982|08/06/1982|||APPR|
P810015|S004|CIBA VISION CARE|2910 AMWILER COURT||ATLANTA|GA|30360||Accessories, soft lens products|SALT TABLETS|LPN|OP|||N|08/30/1982|05/03/1983|||APPR|
P810017|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|||N|03/09/1982|03/25/1982|||APPR|
P810017|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|||N|02/01/1983|08/05/1983|||APPR|
P810017|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) PREMIXED PROTEIN REMOVER SOLUTION|LPN|OP|||N|01/05/1984|10/16/1986|||APPR|
P810017|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|||N|05/02/1984|07/14/1986|||APPR|
P810017|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|||N|03/04/1985|11/14/1986|||APPR|
P810017|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|||N|08/12/1985|12/31/1985|||APPR|
P810017|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|||N|08/12/1985|12/31/1985|||APPR|
P810017|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/1986|10/27/1986|||APPR|
P810017|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|THIRTY DAY TRACK|Other Report|N|11/06/1986|12/01/1986|||APPR|
P810017|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/1987|03/26/1987|||APPR|
P810017|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/14/1987|03/02/1988|||APPR|
P810017|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Special (Immediate Track)|Other Report|N|12/22/1987|03/14/1988|||APPR|
P810017|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/1989|10/13/1989|||APPR|
P810017|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/1989|11/16/1989|||APPR|
P810017|S017|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1990|06/05/1990|||APPR|
P810017|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/1990|05/28/1991|||APPR|
P810017|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE WEEKLY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1990|04/13/1994|||APPR|
P810018|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|12/15/1981|03/10/1983||04/01/1983|APPR|
P810018|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|09/15/1982|03/29/1985|||APPR|
P810018|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|05/06/1983|07/23/1985|||APPR|
P810018|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|07/12/1983|05/14/1985|||APPR|
P810018|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|07/12/1983|05/14/1985|||APPR|
P810018|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|04/30/1985|10/01/1985|||APPR|
P810018|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|09/12/1985|04/11/1986|||APPR|
P810018|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|06/22/1982|01/22/1986|||APPR|
P810018|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|11/01/1985|06/11/1986|||APPR|
P810018|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|11/12/1985|04/11/1986|||APPR|
P810018|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|11/07/1985|05/01/1986|||APPR|
P810018|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|01/24/1986|03/11/1986|||APPR|
P810018|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|02/27/1986|03/12/1986|||APPR|
P810018|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|11/01/1985|04/21/1988|||APPR|
P810018|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|12/30/1985|05/30/1986|||APPR|
P810018|S018|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|||N|04/08/1986|09/29/1986|||APPR|
P810018|S020|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/1986|10/06/1986|||APPR|
P810018|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/1986|10/07/1986|||APPR|
P810018|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/1987|01/22/1988|||APPR|
P810018|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/1987|02/08/1988|||APPR|
P810018|S024|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/1988|05/26/1988|||APPR|
P810018|S027|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/1988|10/19/1989|||APPR|
P810018|S030|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/1991|05/29/1992|||APPR|
P810018|S031|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P810018|S032|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|LASER WELDING (RHAR) PMMA HAPTICS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/1992|05/05/1994|||APPR|
P810020|S001|SMITH & NEPHEW RICHARDS, INC.|1450 BROOKS RD.||MEMPHIS|TN|38116||BONE CEMENT|PALACOS R BONE CEMENT|LOD|OR|||N|06/04/1984|08/14/1984|||APPR|
P810020|S002|SMITH & NEPHEW RICHARDS, INC.|1450 BROOKS RD.||MEMPHIS|TN|38116||BONE CEMENT|PALACOS R BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/1988|01/30/1989|||APPR|
P810020|S003|SMITH & NEPHEW RICHARDS, INC.|1450 BROOKS RD.||MEMPHIS|TN|38116||BONE CEMENT|PALACOS R BONE CEMENT|LOD|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1991|02/14/1992|||APPR|
P810022|S001|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|08/06/1981|11/19/1981|||APPR|
P810022|S003|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|03/02/1984|06/15/1984|||APPR|
P810022|S004|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|03/30/1984|06/15/1984|||APPR|
P810022|S005|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|06/04/1984|09/13/1984|||APPR|
P810022|S006|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|06/18/1984|09/21/1984|||APPR|
P810022|S007|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|10/19/1984|12/04/1984|||APPR|
P810022|S008|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|01/07/1985|03/11/1985|||APPR|
P810022|S009|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|02/19/1985|09/03/1985|||APPR|
P810022|S010|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|05/06/1985|07/01/1985|||APPR|
P810022|S011|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|||N|07/12/1985|11/21/1985|||APPR|
P810022|S012|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|Normal 180 Day Track||N|03/31/1986|06/05/1986|||APPR|
P810022|S013|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1986|01/29/1987|||APPR|
P810022|S014|NOVAMETRIX MEDICAL SYSTEMS, INC.|1 BARNES INDUSTRIAL PARK RD.|P.O. BOX 690|WALLINGFORD|CT|06492||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCO2M MODEL 818 MONITOR|LKD|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1987|10/09/1987|||APPR|
P810023|S002|GAMBRO BCT, INC.|10811 West Collins Ave.||Lakewood|CO|80215||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|COBE CENTRY(R) TPE SYSTEM|LKN|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1993|07/05/1994|||APPR|
P810024|S001|WARNER-LAMBERT CO.|201 TABOR RD., MORRIS PLAINS N|J|||||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MTS PLUS TEST SYTEM|LON|MI|||N|10/20/1983|11/25/1983|||APPR|
P810024|S002|WARNER-LAMBERT CO.|201 TABOR RD., MORRIS PLAINS N|J|||||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MTS PLUS TEST SYTEM|LON|MI|||N|10/15/1985|03/17/1986|||APPR|
P810024|S003|WARNER-LAMBERT CO.|201 TABOR RD., MORRIS PLAINS N|J|||||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MTS PLUS TEST SYTEM|LON|MI|||N|10/18/1985|03/17/1986|||APPR|
P810024|S004|WARNER-LAMBERT CO.|201 TABOR RD., MORRIS PLAINS N|J|||||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|AUTOBAC MTS PLUS TEST SYTEM|LON|MI|||N|10/21/1985|04/12/1988|||APPR|
P810025|S001|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC(TM)|LZP|OP|||N|02/10/1984|05/02/1986|||APPR|
P810025|S002|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYVISC(R)|LZP|OP|||N|02/10/1984|03/26/1984|||APPR|
P810025|S003|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYVISC(R)|LZP|OP|||N|12/17/1984|05/09/1985|||APPR|
P810025|S004|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYVISC(R)|LZP|OP|||N|03/18/1985|06/12/1985|||APPR|
P810025|S005|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYVISC(R)|LZP|OP|||N|11/13/1985|09/10/1987|||APPR|
P810025|S006|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC (R)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1987|10/13/1987|||APPR|
P810025|S007|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC (R)|LZP|OP|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/1987|04/04/1988|||APPR|
P810025|S008|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC (R)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/1988|08/25/1988|||APPR|
P810025|S009|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC (R)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/1988|03/10/1988|||APPR|
P810025|S010|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC (R)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/1988|05/26/1988|||APPR|
P810025|S011|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC (R)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1988|07/26/1988|||APPR|
P810025|S013|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC (R)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1988|01/03/1990|||APPR|
P810025|S015|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC (R)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/1994|03/10/1995|||APPR|
P810028|S001|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|||N|04/26/1983|06/22/1983|||APPR|
P810028|S002|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|||N|05/26/1983|11/17/1983|||APPR|
P810028|S003|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|||N|06/15/1983|12/23/1983|||APPR|
P810028|S004|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|||N|06/21/1984|02/27/1985|||APPR|
P810028|S005|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|||N|09/07/1984|12/17/1984|||APPR|
P810028|S006|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1987|07/14/1988|||APPR|
P810028|S007|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1987|02/22/1988|||APPR|
P810028|S008|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/1987|01/31/1989|||APPR|
P810028|S009|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/1988|04/28/1988|||APPR|
P810028|S010|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1988|02/02/1989|||APPR|
P810028|S011|DEKNATEL, INC.|600 AIRPORT RD.||FALL RIVER|MA|02720||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|DEKLENE(TM)|GAT|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/1989|06/16/1989|||APPR|
P810029|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLN|LPN|OP|||N|06/16/1980|08/21/1981|||APPR|
P810029|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLN|LPN|OP|Special (Immediate Track)||N|06/16/1981|07/21/1982|||APPR|
P810029|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLN|LPN|OP|||N|06/22/1981|03/15/1982|||APPR|
P810029|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLN|LPN|OP|||N|04/12/1982|05/26/1982|||APPR|
P810029|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLN|LPN|OP|||N|03/26/1984|08/07/1984|||APPR|
P810029|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLN|LPN|OP|||N|04/23/1984|11/29/1984|||APPR|
P810029|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLN|LPN|OP|||N|06/04/1984|11/29/1984|||APPR|
P810029|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLN|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1987|05/05/1987|||APPR|
P810029|S009|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
P810029|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|LENSRINS(R) STERILE PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
P810030|S001|CENTRAL PHARMACEUTICALS, INC.|110-128 EAST 3RD ST.||SEYMOUR|IN|47274||Accessories, soft lens products|CENTRAL'S PHARM. SALT TABLETS FOR DISINFECTION|LPN|OP|||N|03/14/1985|08/22/1985|||APPR|
P810031|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|||N|08/31/1983|11/01/1983|||APPR|
P810031|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|||N|01/27/1984|03/15/1984|||APPR|
P810031|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|||N|02/10/1984|05/15/1984|||APPR|
P810031|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|||N|02/23/1984|05/09/1984|||APPR|
P810031|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|||N|09/17/1984|11/19/1984|||APPR|
P810031|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|||N|11/07/1985|11/26/1985|||APPR|
P810031|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|Normal 180 Day Track||N|06/03/1986|07/24/1986|||APPR|
P810031|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/1987|08/27/1987|||APPR|
P810031|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/1988|07/29/1988|||APPR|
P810031|S012|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1988|12/01/1989|||APPR|
P810031|S013|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1989|12/06/1991|||APPR|
P810031|S014|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON(R)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/1990|03/09/1992|||APPR|
P810031|S017|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON GV(TM)|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/23/1994|04/28/1994|||APPR|
P810031|S018|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON(R) VISCOELASTIC PRODUCTS|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/1994|02/17/1995|||APPR|
P810031|S019|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON(R) VISCOELASTIC PRODUCTS|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/1994|05/03/1995|||APPR|
P810032|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|||N|12/28/1982|04/11/1983|||APPR|
P810032|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|||N|06/17/1983|07/27/1983|||APPR|
P810032|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|||N|07/21/1983|06/19/1985|||APPR|
P810032|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|||N|01/26/1984|06/13/1985|||APPR|
P810032|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|||N|08/09/1985|10/10/1985|||APPR|
P810032|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|||N|12/24/1985|01/15/1987|||APPR|
P810032|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|||N|01/23/1986|12/12/1986|||APPR|
P810032|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/1986|01/13/1987|||APPR|
P810032|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/1986|02/17/1987|||APPR|
P810032|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/1987|11/24/1987|||APPR|
P810032|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Other Report|N|05/18/1987|05/03/1988|||APPR|
P810032|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1987|05/03/1988|||APPR|
P810032|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/1987|05/26/1988|||APPR|
P810032|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|7ODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/1987|02/08/1988|||APPR|
P810032|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/1988|06/29/1988|||APPR|
P810032|S020|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/1988|08/14/1989|||APPR|
P810032|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/1988|10/19/1989|||APPR|
P810032|S024|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|1CDELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/1988|08/14/1989|||APPR|
P810032|S025|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1988|11/13/1989|||APPR|
P810032|S026|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/1988|01/16/1990|||APPR|
P810032|S027|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|1CDELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1988|01/16/1990|||APPR|
P810032|S028|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|1CDELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1988|11/22/1989|||APPR|
P810032|S030|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|1CDELS B-13F (P-10) & B-1H (P-11)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1988|01/16/1990|||APPR|
P810032|S041|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|IOL LENS MODEL MC40CM|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/25/1991|11/26/1991|||APPR|
P810032|S042|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|IOL LENS MODEL MC40CM|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/1991|05/29/1992|||APPR|
P810032|S043|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P810032|S044|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|LASER WELDING/(RHAR)PMMA HAPTICS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/1992|05/05/1994|||APPR|
P810032|S045|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|UV ABSORBING POST.CHAM.IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1993|05/01/1995|||APPR|
P810034|S002|BIONOMICS INTL., INC.|7803 SOMERSET BLVD.||PARAMOUNT|CA|90723||Accessories, soft lens products|EYERISOL(R)|LPN|OP|||N|11/04/1983|05/28/1985|||APPR|
P810034|S003|BIONOMICS INTL., INC.|7803 SOMERSET BLVD.||PARAMOUNT|CA|90723||Accessories, soft lens products|EYERISOL(R)|LPN|OP|||N|03/31/1986|08/11/1986|||APPR|
P810037|S001|KONTRON CARDIOVASCULAR|9 PLYMOUTH ST.||EVERETT|MA|02149||MONITOR, CARBON-DIOXIDE, CUTANEOUS|KONTRON CUTANEOUS PCO2 MONITOR|LKD|AN|||N|08/02/1982|09/16/1982|||APPR|
P810037|S002|KONTRON CARDIOVASCULAR|9 PLYMOUTH ST.||EVERETT|MA|02149||MONITOR, CARBON-DIOXIDE, CUTANEOUS|KONTRON CUTANEOUS PCO2 MONITOR|LKD|AN|||N|09/14/1982|12/22/1982|||APPR|
P810037|S003|KONTRON CARDIOVASCULAR|9 PLYMOUTH ST.||EVERETT|MA|02149||MONITOR, CARBON-DIOXIDE, CUTANEOUS|KONTRON CUTANEOUS PCO2 MONITOR|LKD|AN|||N|08/23/1984|01/29/1985|||APPR|
P810037|S004|KONTRON CARDIOVASCULAR|9 PLYMOUTH ST.||EVERETT|MA|02149||MONITOR, CARBON-DIOXIDE, CUTANEOUS|KONTRON CUTANEOUS PCO2 MONITOR|LKD|AN|||N|03/26/1985|09/12/1985|||APPR|
P810037|S005|KONTRON CARDIOVASCULAR|9 PLYMOUTH ST.||EVERETT|MA|02149||MONITOR, CARBON-DIOXIDE, CUTANEOUS|KONTRON CUTANEOUS PCO2 MONITOR|LKD|AN|||N|03/26/1985|08/22/1985|||APPR|
P810037|S006|KONTRON CARDIOVASCULAR|9 PLYMOUTH ST.||EVERETT|MA|02149||MONITOR, CARBON-DIOXIDE, CUTANEOUS|KONTRON CUTANEOUS PCO2 MONITOR|LKD|AN|||N|05/21/1985|09/12/1985|||APPR|
P810039|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|11/15/1982|12/30/1982|||APPR|
P810039|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|12/03/1982|02/10/1983|||APPR|
P810039|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|02/28/1983|02/25/1985|||APPR|
P810039|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|04/01/1983|08/24/1983|||APPR|
P810039|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|04/22/1983|02/25/1985|||APPR|
P810039|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|07/25/1983|02/08/1984|||APPR|
P810039|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|12/08/1983|02/25/1985|||APPR|
P810039|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|12/12/1983|02/27/1987|||APPR|
P810039|S009|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|02/08/1984|01/29/1985|||APPR|
P810039|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|||N|04/09/1984|08/29/1985|||APPR|
P810039|S011|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/24/1986|07/11/1986|||APPR|
P810039|S012|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/1986|08/07/1986|||APPR|
P810039|S013|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1987|06/22/1987|||APPR|
P810039|S014|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/1988|03/14/1988|||APPR|
P810039|S015|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1988|07/07/1988|||APPR|
P810039|S016|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Other Report|N|08/05/1988|09/26/1988|||APPR|
P810039|S017|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Accessories, soft lens products|SENSITIVE EYES(TM) SALINE SOLUTION (2ML) SIZE|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|05/28/1993|||APPR|
P810040|S001|SUPERSTAT CORP.|2015 UNIVERSITY DR.||RANCHO DOMINGUEZ|CA|90220|6411|Agent, absorbable hemostatic, collagen based|SUPERSTAT|LMF|SU|Normal 180 Day Track||N|02/17/1982|06/23/1982|||APPR|
P810040|S003|SUPERSTAT CORP.|2015 UNIVERSITY DR.||RANCHO DOMINGUEZ|CA|90220|6411|Agent, absorbable hemostatic, collagen based|SUPERSTAT|LMF|SU|||N|09/29/1983|07/18/1984|||APPR|
P810040|S005|SUPERSTAT CORP.|2015 UNIVERSITY DR.||RANCHO DOMINGUEZ|CA|90220|6411|Agent, absorbable hemostatic, collagen based|SUPERSTAT|LMF|SU|||N|12/14/1983|02/22/1984|||APPR|
P810040|S006|SUPERSTAT CORP.|2015 UNIVERSITY DR.||RANCHO DOMINGUEZ|CA|90220|6411|Agent, absorbable hemostatic, collagen based|SUPERSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/1988|01/30/1989|||APPR|
P810040|S007|SUPERSTAT CORP.|2015 UNIVERSITY DR.||RANCHO DOMINGUEZ|CA|90220|6411|Agent, absorbable hemostatic, collagen based|SUPERSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/1991|04/21/1995|||APPR|
P810041|S001|LOBOB LABORATORIES, INC.|1440 ATTEBERRY LN.||SAN JOSE|CA|95131|1410|Accessories, soft lens products|SOF!PRO-CLEAN CONTACT LENS CLEANER|LPN|OP|||N|07/08/1982|08/20/1982|||APPR|
P810041|S003|LOBOB LABORATORIES, INC.|1440 ATTEBERRY LN.||SAN JOSE|CA|95131|1410|Accessories, soft lens products|SOF!PRO-CLEAN CONTACT LENS CLEANER|LPN|OP|||N|12/07/1983|06/04/1984|||APPR|
P810041|S004|LOBOB LABORATORIES, INC.|1440 ATTEBERRY LN.||SAN JOSE|CA|95131|1410|Accessories, soft lens products|SOF!PRO-CLEAN CONTACT LENS CLEANER|LPN|OP|||N|03/15/1985|07/07/1986|||APPR|
P810041|S005|LOBOB LABORATORIES, INC.|1440 ATTEBERRY LN.||SAN JOSE|CA|95131|1410|Accessories, soft lens products|SOF PRO-CLEAN CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/1986|06/24/1986|||APPR|
P810041|S006|LOBOB LABORATORIES, INC.|1440 ATTEBERRY LN.||SAN JOSE|CA|95131|1410|Accessories, soft lens products|SOF PRO-CLEAN CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/30/1986|03/16/1988|||APPR|
P810041|S007|LOBOB LABORATORIES, INC.|1440 ATTEBERRY LN.||SAN JOSE|CA|95131|1410|Accessories, soft lens products|SOF PRO-CLEAN CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/1990|09/13/1990|||APPR|
P810044|S001|DIABETES SENTRY PRODUCTS, LLC|501 Samuels Ave.|Unit #110|Fort Worth|TX|76102||MONITOR, SKIN RESISTANCE/SKIN TEMPERATURE,  FOR INSULIN REACTIONS|SLEEP SENTRY(TM)|LMY|HO|||N|11/23/1982|09/13/1983|||APPR|
P810044|S002|DIABETES SENTRY PRODUCTS, LLC|501 Samuels Ave.|Unit #110|Fort Worth|TX|76102||MONITOR, SKIN RESISTANCE/SKIN TEMPERATURE,  FOR INSULIN REACTIONS|SLEEP SENTRY(TM)|LMY|HO|||N|03/16/1983|04/27/1983|||APPR|
P810044|S003|DIABETES SENTRY PRODUCTS, LLC|501 Samuels Ave.|Unit #110|Fort Worth|TX|76102||MONITOR, SKIN RESISTANCE/SKIN TEMPERATURE,  FOR INSULIN REACTIONS|SLEEP SENTRY(TM)|LMY|HO|||N|04/19/1984|05/03/1984|||APPR|
P810046|S001|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|03/22/1982|04/27/1982|||APPR|
P810046|S002|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|11/17/1982|01/14/1983|||APPR|
P810046|S003|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|04/22/1983|07/25/1983|||APPR|
P810046|S004|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|05/02/1983|11/07/1984|||APPR|
P810046|S006|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|05/31/1983|07/26/1983|||APPR|
P810046|S007|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|06/07/1983|11/21/1984|||APPR|
P810046|S008|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|06/21/1983|06/08/1984|||APPR|
P810046|S009|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|11/14/1983|03/25/1985|||APPR|
P810046|S010|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|01/19/1984|11/30/1984|||APPR|
P810046|S011|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|04/27/1984|11/08/1984|||APPR|
P810046|S012|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|12/19/1984|09/10/1985|||APPR|
P810046|S014|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|07/22/1985|09/10/1985|||APPR|
P810046|S015|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|08/01/1985|03/06/1986|||APPR|
P810046|S016|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|09/10/1985|03/06/1986|||APPR|
P810046|S017|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|10/03/1985|12/12/1985|||APPR|
P810046|S018|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|10/15/1985|01/09/1986|||APPR|
P810046|S019|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|10/18/1985|03/27/1986|||APPR|
P810046|S020|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|10/25/1985|03/27/1986|||APPR|
P810046|S021|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|||N|01/14/1986|05/23/1986|||APPR|
P810046|S023|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Other Report|N|06/02/1986|08/25/1986|||APPR|
P810046|S024|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/1986|07/17/1986|||APPR|
P810046|S025|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/1986|03/05/1987|||APPR|
P810046|S026|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1986|05/22/1987|||APPR|
P810046|S027|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Other Report|N|09/12/1986|02/03/1987|||APPR|
P810046|S029|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1987|06/26/1987|||APPR|
P810046|S031|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/1987|06/26/1987|||APPR|
P810046|S032|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Other Report|N|05/26/1987|08/22/1988|||APPR|
P810046|S033|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/1987|08/12/1987|||APPR|
P810046|S034|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/1987|09/16/1987|||APPR|
P810046|S035|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/1987|01/29/1988|||APPR|
P810046|S036|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/1987|10/06/1987|||APPR|
P810046|S038|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/08/1987|03/17/1988|||APPR|
P810046|S039|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1987|02/02/1988|||APPR|
P810046|S040|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/1987|02/02/1988|||APPR|
P810046|S041|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1987|03/17/1988|||APPR|
P810046|S042|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/1987|02/29/1988|||APPR|
P810046|S043|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/1988|04/22/1988|||APPR|
P810046|S044|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/28/1988|04/22/1988|||APPR|
P810046|S045|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1988|09/23/1988|||APPR|
P810046|S046|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/1988|06/27/1988|||APPR|
P810046|S047|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Panel Track|Change Design/Components/Specifications/Material|N|05/03/1988|01/11/1989|89M-0024|03/02/1989|APPR|
P810046|S048|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/1988|07/11/1988|||APPR|
P810046|S049|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/1988|12/28/1988|||APPR|
P810046|S050|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1988|02/02/1989|||APPR|
P810046|S051|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1988|05/22/1989|||APPR|
P810046|S052|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1988|01/27/1989|||APPR|
P810046|S053|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1989|03/09/1989|||APPR|
P810046|S054|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1989|03/09/1989|||APPR|
P810046|S055|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/1989|07/20/1989|||APPR|
P810046|S057|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1989|09/11/1989|||APPR|
P810046|S058|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|PINKERTON .018(TM) COMPOSITE DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1989|01/18/1990|||APPR|
P810046|S059|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|~RMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/1989|02/07/1990|||APPR|
P810046|S060|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/1989|09/29/1989|||APPR|
P810046|S061|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/1989|09/29/1989|||APPR|
P810046|S062|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1989|10/16/1989|||APPR|
P810046|S063|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/1989|03/06/1990|||APPR|
P810046|S064|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1989|12/14/1989|||APPR|
P810046|S065|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS HARTZLER ACX II CORONARY DILATATION BALLOON CA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/1989|04/24/1990|||APPR|
P810046|S066|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS PINKERTON .018  CORONARY DILATATION BALLOON CA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1989|02/21/1990|||APPR|
P810046|S067|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1989|04/20/1990|||APPR|
P810046|S068|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS R STACK PERFUSION DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/21/1989|02/27/1990|||APPR|
P810046|S069|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS HATZLER MICRO-600 DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1989|02/28/1990|||APPR|
P810046|S070|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HARTZLER EXCEL II TM CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/22/1990|07/16/1990|||APPR|
P810046|S071|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA PRIME  CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Other Report|N|03/14/1990|05/30/1990|||APPR|
P810046|S072|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/1990|12/12/1990|||APPR|
P810046|S073|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/1990|09/12/1990|||APPR|
P810046|S074|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) STACK PERFUSION(R) CORONARY DIL. CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/1990|06/19/1990|||APPR|
P810046|S075|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) STACK 40(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/1990|08/23/1990|||APPR|
P810046|S076|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) STACK PERFUSION(R) CORONARY DILATATION CATH|LOX|CV|Normal 180 Day Track|Other Report|N|05/29/1990|08/23/1990|||APPR|
P810046|S077|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) HARTZLER EXCEL CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1990|12/18/1990|||APPR|
P810046|S078|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) STACK PERFUSION(R) CORONARY DILATATION CATH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1990|09/14/1990|||APPR|
P810046|S079|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) RX PERFUSION(TM) CORONARY DILATATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/1990|10/04/1990|||APPR|
P810046|S080|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/1990|10/10/1990|||APPR|
P810046|S081|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA(TM) .014 CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/05/1990|08/23/1990|||APPR|
P810046|S083|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX(R) - .014 CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1990|10/05/1990|||APPR|
P810046|S084|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/27/1990|11/01/1990|||APPR|
P810046|S085|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) TEN(TM) (.010) DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1990|12/10/1990|||APPR|
P810046|S086|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) STACK 40-S(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1990|11/15/1990|||APPR|
P810046|S087|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1990|01/14/1991|||APPR|
P810046|S088|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SLALOM(TM) DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/1990|12/04/1990|||APPR|
P810046|S089|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) STACK PERFUSION(R) DISTAL FLOW COR. DIL. CA|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/15/1990|09/21/1990|||APPR|
P810046|S091|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SLALOM(TM) DILATATION CATHETRER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/1990|12/27/1990|||APPR|
P810046|S093|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA(TM) .014 CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/1990|11/14/1990|||APPR|
P810046|S094|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS HP CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/09/1990|01/17/1991|||APPR|
P810046|S095|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) STACK PERFUSION(R) CORONARY DILATATION CATH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1990|03/20/1991|||APPR|
P810046|S096|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA(TM) .018 CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/20/1990|05/30/1991|||APPR|
P810046|S097|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS PINKERTON .018(TM)CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1990|03/20/1991|||APPR|
P810046|S098|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA(TM).010 CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1990|06/27/1991|||APPR|
P810046|S099|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SELF-VENT TO ACS CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/07/1991|06/17/1991|||APPR|
P810046|S100|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SELF-VENT TO ACS CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/1991|07/25/1991|||APPR|
P810046|S101|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA .014 QUARTER SIZE BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/1990|04/25/1991|||APPR|
P810046|S102|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS, OMEGA DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1991|01/02/1992|||APPR|
P810046|S103|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SPECTRUM(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/1991|06/25/1991|||APPR|
P810046|S104|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HARTZLER ACX II(R) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/1991|01/17/1992|||APPR|
P810046|S105|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX(R) ALPHA .O14 CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1991|08/15/1991|||APPR|
P810046|S106|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS XT 600 CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1991|02/10/1992|||APPR|
P810046|S107|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CORONARY DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/1991|11/20/1991|||APPR|
P810046|S108|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA CORONARY DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/18/1991|08/06/1991|||APPR|
P810046|S109|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA CORONARY DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/08/1991|09/04/1991|||APPR|
P810046|S110|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ALPHA CORONARY DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/1991|03/04/1992|||APPR|
P810046|S111|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SLALOM(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/1991|01/16/1992|||APPR|
P810046|S112|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SLALOM(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/17/1991|02/04/1992|||APPR|
P810046|S113|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SLALOM(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1991|02/07/1992|||APPR|
P810046|S114|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY BALLOON DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1991|01/17/1992|||APPR|
P810046|S115|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS (R) RX STREAK (TM)CORONARY DILATION CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/1991|01/16/1992|||APPR|
P810046|S116|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS (R) RX STREAK (TM)CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1991|03/24/1992|||APPR|
P810046|S117|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/23/1991|04/09/1992|||APPR|
P810046|S118|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) RX FLOWTRACK(TM) 40 CORONARY DILITATIN CATH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1991|10/29/1992|||APPR|
P810046|S119|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS STACK 40-S(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1992|07/10/1992|||APPR|
P810046|S121|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX PERFUSION CORON. DILATION CATHETER ADD 2.0|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/1992|07/10/1992|||APPR|
P810046|S122|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|STACK PERFUSION IV CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/1992|07/29/1993|||APPR|
P810046|S123|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CHANGES TO ACS(R) RX STREAK(TM).014 & .010 CATH.|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/1992|03/24/1992|||APPR|
P810046|S124|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/1992|09/30/1993|||APPR|
P810046|S125|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/1992|07/07/1993|||APPR|
P810046|S126|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CHANGES TO PINKERTON & OMEGA CORO.DIL. CATHETERS|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1992|07/21/1993|||APPR|
P810046|S127|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ELIPSE & ELIPSE II CORO.DIL. CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/1992|09/14/1993|||APPR|
P810046|S129|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX STREAK (TM) & FLOWTRACK DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1992|02/11/1993|||APPR|
P810046|S130|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS EDGE(TM) CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1992|07/23/1993|||APPR|
P810046|S131|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX PRIMAFLOW (TM) CORO.DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/1992|06/14/1994|||APPR|
P810046|S132|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX STREAK(TM) .014 CORONARY DILATATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/1992|10/01/1992|||APPR|
P810046|S133|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX PERFUSION(TM)   CORONARY DILATATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/03/1992|11/05/1992|||APPR|
P810046|S134|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS STACK 40-S(TM)  CORONARY DILATATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/03/1992|03/18/1993|||APPR|
P810046|S135|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX STREAK(TM) .010 CORONARY DILATATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/1992|02/11/1993|||APPR|
P810046|S136|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS PRISM(TM) & PINKERTON .018(TM)COR.DIL. CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1992|03/19/1993|||APPR|
P810046|S137|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS TEN (TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1992|04/28/1993|||APPR|
P810046|S138|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX PERFUSION(TM)  DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1992|05/04/1993|||APPR|
P810046|S139|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/1992|08/06/1993|||APPR|
P810046|S140|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ELIPSE(TM) .014 CORONARY DILITATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/1993|10/21/1993|||APPR|
P810046|S141|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX FLOWTRACK (TM) 40 CORO.  DILITATION CATH.|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/1993|08/24/1993|||APPR|
P810046|S142|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1993|09/02/1993|||APPR|
P810046|S143|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/1993|01/27/1994|||APPR|
P810046|S144|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS EDGE (TM)DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/12/1993|06/13/1994|||APPR|
P810046|S145|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SPACTRUM(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/1993|10/13/1993|||APPR|
P810046|S146|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|RX ELIPSE(TM) .014 CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/1993|11/08/1993|||APPR|
P810046|S147|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX PERFUSION(TM) CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/1993|04/04/1994|||APPR|
P810046|S148|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX FLOWTRACK(TM) LONG COR. DILITATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1994|07/11/1994|||APPR|
P810046|S149|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ELIPSE(TM) .014 CORNARY DILITATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1994|08/04/1994|||APPR|
P810046|S150|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1994|06/14/1994|||APPR|
P810046|S151|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1994|03/23/1995|||APPR|
P810046|S152|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX FLOWTRACK LONG(TM) CORONARY DILATATION CATH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/1994|11/14/1994|||APPR|
P810046|S153|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX LIFESTREAM(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1994|03/23/1995|||APPR|
P810047|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|HYDRON(TM) SALINE SYSTEM (135 & 250MG)|LPN|OP|||N|05/18/1982|07/16/1982|||APPR|
P810047|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|HYDRON(TM) SALINE SYSTEM (135 & 250MG)|LPN|OP|||N|05/28/1982|10/21/1982||02/25/1983|APPR|
P810048|S001|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Normal 180 Day Track||N|12/21/1982|02/09/1983|||APPR|
P810048|S003|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Normal 180 Day Track||N|07/26/1983|10/26/1983|||APPR|
P810048|S006|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Normal 180 Day Track||N|12/13/1984|03/06/1985|||APPR|
P810048|S007|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Normal 180 Day Track||N|02/19/1985|03/22/1985|||APPR|
P810048|S008|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Normal 180 Day Track||N|02/26/1985|03/22/1985|||APPR|
P810048|S009|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Special (Immediate Track)||N|12/26/1985|06/03/1986|||APPR|
P810048|S010|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Normal 180 Day Track||N|05/01/1986|11/05/1986|||APPR|
P810048|S011|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/30/1986|07/01/1987|||APPR|
P810048|S012|Smith & Nephew, Inc.|1450 BROOKS RD.||MEMPHIS|TN|38116||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEO CERAMIC HIP|MRA|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/28/1986|05/10/1988|||APPR|
P810050|S001|OPTECH, INC.|7310 SOUTH ALTON WAY, SUITE E||ENGLEWOOD|CO|80112||Lenses, soft contact, daily wear|OPTECH FRE-FLEX SOFT CONTACT LENS|LPL|OP|||N|05/02/1983|07/05/1983|||APPR|
P810050|S002|OPTECH, INC.|7310 SOUTH ALTON WAY, SUITE E||ENGLEWOOD|CO|80112||Lenses, soft contact, daily wear|OPTECH FRE-FLEX SOFT CONTACT LENS|LPL|OP|||N|07/21/1983|11/20/1984|||APPR|
P810055|S002|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|04/08/1983|05/03/1983|||APPR|
P810055|S003|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|05/31/1983|04/22/1985|||APPR|
P810055|S004|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|06/09/1983|04/11/1985|||APPR|
P810055|S005|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|08/08/1983|07/19/1985|||APPR|
P810055|S006|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|09/02/1983|07/19/1985|||APPR|
P810055|S008|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|12/02/1983|09/05/1985|||APPR|
P810055|S010|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|05/31/1984|01/31/1986|||APPR|
P810055|S012|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|10/01/1984|07/23/1985|||APPR|
P810055|S013|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|04/11/1985|02/20/1986|||APPR|
P810055|S014|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|04/22/1985|05/17/1985|||APPR|
P810055|S015|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|05/02/1985|07/19/1985|||APPR|
P810055|S016|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|||N|05/02/1985|08/07/1985|||APPR|
P810055|S017|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Panel Track|Other Report|N|03/28/1986|10/06/1987|87M-0347|11/16/1987|APPR|
P810055|S018|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1986|01/16/1987|||APPR|
P810055|S019|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1987|10/16/1987|||APPR|
P810055|S020|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1987|10/16/1987|||APPR|
P810055|S021|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1987|01/20/1988|||APPR|
P810055|S022|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1987|02/19/1988|||APPR|
P810055|S023|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/1987|03/02/1988|||APPR|
P810055|S024|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/13/1987|12/22/1987|||APPR|
P810055|S025|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1987|12/22/1989|||APPR|
P810055|S026|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1987|03/30/1990|||APPR|
P810055|S027|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/1987|03/14/1988|||APPR|
P810055|S028|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/11/1988|03/01/1988|||APPR|
P810055|S029|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/1988|04/12/1988|||APPR|
P810055|S030|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1988|08/11/1988|||APPR|
P810055|S031|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/1988|08/18/1989|||APPR|
P810055|S032|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|10/27/1988|01/10/1989|||APPR|
P810055|S033|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1988|12/04/1989|||APPR|
P810055|S034|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1989|08/22/1989|||APPR|
P810055|S037|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 019B, 019C, 019E, 019F, 019J, & 019K|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/1989|03/19/1990|||APPR|
P810055|S038|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 720M ULTRAVIOLET LIGHT-ABSORBING LENS (POST)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1989|08/31/1990|||APPR|
P810055|S039|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 720M ULTRAVIOLET LIGHT-ABSORBING LENS (POST)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/1989|01/08/1990|||APPR|
P810055|S040|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UV95 ULTRAVIOLET LIGHT-ABSORBING LENS (POST)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/1989|04/16/1990|||APPR|
P810055|S041|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/1989|01/14/1991|||APPR|
P810055|S042|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/1990|03/20/1991|||APPR|
P810055|S043|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/1990|05/08/1990|||APPR|
P810055|S044|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/1990|11/06/1992|||APPR|
P810055|S047|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS 150A  150SE ULTRA VOILET-ABSORB. POSTERIOR|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/1990|03/20/1991|||APPR|
P810055|S050|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|TIER A LENS MODEL 722D|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/1991|07/03/1991|||APPR|
P810055|S051|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|KABI PHARMACIA ONE PIECE LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/1991|09/20/1994|||APPR|
P810055|S052|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|GETINGE ETHYLENE OXIDE STERILIZER|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1991|08/27/1991|||APPR|
P810055|S053|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|CM(TM) LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1992|08/23/1994|||APPR|
P810055|S054|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|CM(TM) LENSES       MODEL 722D|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/1992|01/27/1994|||APPR|
P810055|S055|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|CM(TM) LENSES       MODEL 820A|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/1992|01/27/1995|||APPR|
P810055|S056|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|ONE PIECE (NON-CM) TM POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/1992|01/05/1995|||APPR|
P810055|S057|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 727A POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1992|01/05/1995|||APPR|
P810055|S058|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 734A POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/1992|01/05/1995|||APPR|
P810055|S059|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|ONE PIECE CM (R) POS.CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/1992|01/05/1995|||APPR|
P810055|S061|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 809F TIER A POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/1992|01/27/1995|||APPR|
P810055|S063|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 809A POTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/1993|12/02/1994|||APPR|
P810056|S002|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|||N|07/15/1985|03/11/1986|||APPR|
P810056|S003|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1986|10/15/1986|||APPR|
P810056|S004|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/1986|01/13/1987|||APPR|
P810056|S005|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1987|12/07/1987|||APPR|
P810056|S006|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|Normal 180 Day Track|Other Report|N|06/24/1987|12/18/1987|||APPR|
P810056|S007|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/1988|08/16/1988|||APPR|
P810056|S008|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1988|02/27/1989|||APPR|
P810056|S009|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC10 & AC20 IOLS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/10/1988|02/14/1989|||APPR|
P810057|S001|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|||N|09/07/1982|10/08/1982|||APPR|
P810057|S002|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1987|02/08/1989|||APPR|
P810057|S003|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/1988|08/11/1988|||APPR|
P810057|S004|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/1989|09/19/1989|||APPR|
P810057|S005|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1989|06/22/1989|||APPR|
P810057|S006|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1989|09/22/1989|||APPR|
P810057|S007|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/1990|05/08/1990|||APPR|
P810057|S008|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/1990|08/31/1990|||APPR|
P810057|S009|COOPERVISION, INC.|200 WILLOWBROOK OFFICE PARK||FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1990|03/28/1991|||APPR|
P820001|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|||N|06/07/1983|01/10/1985|||APPR|
P820001|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|||N|11/04/1983|07/24/1984|||APPR|
P820001|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|||N|12/08/1983|02/06/1987|||APPR|
P820001|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-ZYME(TM) ENZYMATIC CLEANER|LPN|OP|||N|04/16/1984|12/18/1984|||APPR|
P820001|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-ZYME(TM) ENZYAMTIC CLEANER|LPN|OP|||N|04/18/1984|06/04/1984|||APPR|
P820001|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|||N|08/21/1985|02/14/1986|||APPR|
P820001|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|||N|09/13/1985|04/14/1986|||APPR|
P820001|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|||N|09/24/1985|03/06/1987|||APPR|
P820001|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/11/1986|02/06/1987|||APPR|
P820001|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1987|02/19/1988|||APPR|
P820001|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/1987|12/27/1989|||APPR|
P820001|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/10/1988|12/20/1988|||APPR|
P820001|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/1989|05/02/1989|||APPR|
P820001|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1988|09/19/1990|||APPR|
P820001|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/1990|07/17/1990|||APPR|
P820001|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ALCON ENZYME CLEANER|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P820002|S001|STRATO MEDICAL CORP.|PFIZER HOSPITAL PRODUCTS GROUP|123 BRIMBAL AVE|BEVERLY|MA|01915||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|CRYOMAX(TM)|LKN|GU|||N|03/15/1983|04/26/1983|||APPR|
P820002|S002|STRATO MEDICAL CORP.|PFIZER HOSPITAL PRODUCTS GROUP|123 BRIMBAL AVE|BEVERLY|MA|01915||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|CRYOMAX(TM)|LKN|GU|||N|05/02/1983|08/03/1983|||APPR|
P820003|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|11/17/1982|03/01/1983|||APPR|
P820003|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|01/03/1983|04/22/1983|||APPR|
P820003|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|02/01/1983|11/17/1983|||APPR|
P820003|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|02/14/1983|11/17/1983|||APPR|
P820003|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|05/10/1983|06/03/1983|||APPR|
P820003|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|05/31/1983|09/13/1983|||APPR|
P820003|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|11/10/1983|06/04/1984|||APPR|
P820003|S009|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|12/06/1983|04/27/1984|||APPR|
P820003|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|02/08/1984|09/05/1984|||APPR|
P820003|S011|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|05/29/1984|08/21/1984|||APPR|
P820003|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|10/02/1984|02/02/1985|||APPR|
P820003|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|10/26/1984|04/22/1985|||APPR|
P820003|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|12/13/1984|02/02/1985|||APPR|
P820003|S016|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|01/04/1985|10/10/1985|||APPR|
P820003|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|02/22/1985|04/22/1985|||APPR|
P820003|S018|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|02/28/1985|04/22/1985|||APPR|
P820003|S019|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|03/14/1985|05/17/1985|||APPR|
P820003|S021|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|06/25/1985|11/05/1985|||APPR|
P820003|S022|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|09/20/1985|03/27/1986|||APPR|
P820003|S023|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|10/22/1985|02/26/1986|||APPR|
P820003|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|11/08/1985|05/07/1986|||APPR|
P820003|S025|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|12/24/1985|03/27/1986|||APPR|
P820003|S026|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|02/03/1986|04/25/1986|||APPR|
P820003|S027|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|||N|03/19/1986|06/30/1986|||APPR|
P820003|S028|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/1986|07/17/1986|||APPR|
P820003|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1986|02/10/1987|||APPR|
P820003|S030|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1986|03/02/1987|||APPR|
P820003|S031|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/1987|06/26/1987|||APPR|
P820003|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Other Report|N|06/29/1987|07/28/1987|||APPR|
P820003|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/1987|09/16/1987|||APPR|
P820003|S034|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1987|11/02/1987|||APPR|
P820003|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/1988|04/14/1988|||APPR|
P820003|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1988|04/21/1988|||APPR|
P820003|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/17/1988|05/09/1988|||APPR|
P820003|S038|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/14/1988|12/29/1988|||APPR|
P820003|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1988|12/12/1988|||APPR|
P820003|S040|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYNERGYST PULSE GENERATORS MODEL 7026/7027|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1988|02/06/1989|||APPR|
P820003|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYNERGYST PULSE GENERATORS MODEL 7026/7027|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/1989|02/06/1989|||APPR|
P820003|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYNERGYST PULSE GENERATORS MODEL 7026/7027|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/22/1989|04/13/1989|||APPR|
P820003|S043|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYNERGYST PULSE GENERATORS MODEL 7026/7027|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1989|11/16/1989|||APPR|
P820003|S044|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYNERGYST PULSE GENERATORS MODEL 7026/7027|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/1989|09/06/1989|||APPR|
P820003|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 9710E ENHEANCED PROGRAMMING SYSTEM|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/1989|10/30/1989|||APPR|
P820003|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 9710E ENHEANCED PROGRAMMING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1989|01/04/1990|||APPR|
P820003|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 9710E ENHEANCED PROGRAMMING SYSTEM|LWP|CV|Normal 180 Day Track|Other Report|N|11/30/1989|01/18/1990|||APPR|
P820003|S048|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 9710E ENHEANCED PROGRAMMING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1990|06/28/1990|||APPR|
P820003|S049|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 9710E ENHEANCED PROGRAMMING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/1990|07/20/1990|||APPR|
P820003|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 5345 & 5342 TEMPORARY PULSE GENERATORS|LWP|CV|Normal 180 Day Track|Other Report|N|03/13/1990|11/06/1990|||APPR|
P820003|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX MODEL 7000 PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/1990|07/05/1990|||APPR|
P820003|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 9710A PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1990|12/04/1990|||APPR|
P820003|S053|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX(TM) CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Other Report|N|08/14/1990|05/08/1991|||APPR|
P820003|S054|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYMBIOS MODEL 7006 & SYNERGYST MODEL 7026 PULSE G.|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/1990|12/18/1990|||APPR|
P820003|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYMBIOS MODEL 7006 & SYNERGYST MODEL 7026 PULSE G.|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1990|12/27/1990|||APPR|
P820003|S056|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|9751A SYSTEM ENHANCEMENT MODULE (SEM)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1990|04/02/1991|||APPR|
P820003|S057|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 5342 & 5345 TEMPORARY PULSE GENERATORS|LWP|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|01/04/1991|02/06/1991|||APPR|
P820003|S058|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX,SYMBIOS, & SYNERGYST MODELS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/1991|05/08/1991|||APPR|
P820003|S059|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|9751B SYSTEM ENHANCEMENT MODULE PRINTER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/1991|09/27/1991|||APPR|
P820003|S060|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC(R) 7000 VERSATRAX(R) PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1991|12/18/1991|||APPR|
P820003|S061|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC(R) MODEL 5342 & 5245 PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/1991|06/16/1992|||APPR|
P820003|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC(R) MODEL 7000 VERSATRAX(R) PULSE GEN.|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/22/1991|02/07/1992|||APPR|
P820003|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC(R) MODELS 5342 & 5345 TEMP. PULSE GEN.|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/1992|06/09/1992|||APPR|
P820003|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1992|11/16/1992|||APPR|
P820003|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC(R) MODEL 5346 TEMPORARY PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/1993|08/04/1993|||APPR|
P820003|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC VERSATRAX PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Other Report|N|06/14/1993|01/26/1994|||APPR|
P820003|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 5423 ECG CABLE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1993|08/10/1993|||APPR|
P820003|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/1994|08/15/1994|||APPR|
P820003|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1994|01/23/1995|||APPR|
P820005|S001|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|(POLYMACON) CONTACT LENSES|LPL|OP|||N|06/15/1982|07/21/1982|||APPR|
P820005|S003|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|CELUSOFT (POLYMACON) LENS|LPL|OP|||N|12/27/1982|03/15/1983|||APPR|
P820005|S004|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|(POLYMACON) CONTACT LENSES|LPL|OP|||N|03/04/1983|02/20/1987|||APPR|
P820005|S006|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|(POLYMACON) SOF-FORM II CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/1989|01/31/1990|||APPR|
P820005|S007|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|(POLYMACON) SOF-FORM II CONTACT LENSES|LPL|OP|Normal 180 Day Track|Other Report|N|08/02/1990|09/07/1990|||APPR|
P820008|S001|EBI, L.P.|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||STIMULATOR, FUNCTIONAL NEUROMUSCULAR, SCOLIOSIS|SCOLITRON(TM) STIMULATOR|LWB|PM|||N|01/17/1983|06/14/1983|||APPR|
P820008|S002|EBI, L.P.|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||STIMULATOR, FUNCTIONAL NEUROMUSCULAR, SCOLIOSIS|SCOLITRON(TM) STIMULATOR|LWB|PM|||N|09/03/1985|01/17/1986|||APPR|
P820008|S003|EBI, L.P.|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||STIMULATOR, FUNCTIONAL NEUROMUSCULAR, SCOLIOSIS|SCOLITRON(TM) STIMULATOR|LWB|PM|||N|07/01/1985|09/12/1986|||APPR|
P820008|S004|EBI, L.P.|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||STIMULATOR, FUNCTIONAL NEUROMUSCULAR, SCOLIOSIS|SCOLITRON(TM) STIMULATOR|LWB|PM|Normal 180 Day Track|Other Report|N|10/10/1986|01/07/1987|||APPR|
P820008|S005|EBI, L.P.|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||STIMULATOR, FUNCTIONAL NEUROMUSCULAR, SCOLIOSIS|SCOLITRON(TM) STIMULATOR|LWB|PM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/16/1987|04/02/1987|||APPR|
P820009|S001|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Catheter, balloon for retinal reattachment|LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER|LOG|OP|Normal 180 Day Track||N|06/27/1985|09/05/1985|||APPR|
P820009|S003|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Catheter, balloon for retinal reattachment|LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER|LOG|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/1986|09/18/1986|||APPR|
P820012|S001|Integra LifeSciences Corp.|22 TERRY AVENUE||BURLINGTON|MA|01803||MONITOR, INTRACRANIAL PRESSURE, IMPLANTED|ICP TELE-MONITOR & ICP TELE-SENSOR|LII|NE|||N|10/04/1982|11/08/1982|||APPR|
P820012|S002|Integra LifeSciences Corp.|22 TERRY AVENUE||BURLINGTON|MA|01803||MONITOR, INTRACRANIAL PRESSURE, IMPLANTED|COSMAN ICP TELE-SENSOR(R) & COSMAN|LII|NE|||N|11/02/1982|11/23/1982|||APPR|
P820012|S003|Integra LifeSciences Corp.|22 TERRY AVENUE||BURLINGTON|MA|01803||MONITOR, INTRACRANIAL PRESSURE, IMPLANTED|COSMAN ICP TELE-SENSOR(R)|LII|NE|||N|11/01/1983|10/19/1984||11/21/1984|APPR|
P820012|S005|Integra LifeSciences Corp.|22 TERRY AVENUE||BURLINGTON|MA|01803||MONITOR, INTRACRANIAL PRESSURE, IMPLANTED|COSMAN ICP TELE-SENSOR(R)|LII|NE|||N|08/09/1984|09/19/1984|||APPR|
P820014|S001|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|03/02/1982|11/24/1982|||APPR|
P820014|S002|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|09/24/1982|02/17/1983|||APPR|
P820014|S003|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|04/21/1983|07/28/1983|||APPR|
P820014|S004|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|04/27/1983|07/28/1983|||APPR|
P820014|S005|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|08/22/1983|09/23/1983|||APPR|
P820014|S006|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|12/08/1983|03/08/1984|||APPR|
P820014|S007|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|01/10/1984|02/08/1984|||APPR|
P820014|S008|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|09/06/1984|11/19/1984|||APPR|
P820014|S009|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|09/10/1984|06/19/1985|||APPR|
P820014|S010|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|10/15/1984|06/10/1985|||APPR|
P820014|S012|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|12/24/1984|05/05/1986|||APPR|
P820014|S014|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|12/31/1984|04/09/1985|||APPR|
P820014|S015|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|02/25/1985|04/17/1985|||APPR|
P820014|S017|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|04/09/1985|06/11/1985|||APPR|
P820014|S019|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|07/12/1985|08/12/1985|||APPR|
P820014|S020|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|08/09/1985|12/30/1985|||APPR|
P820014|S021|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|10/15/1985|11/05/1985|||APPR|
P820014|S022|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|11/20/1985|02/12/1986|||APPR|
P820014|S023|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|12/06/1985|03/14/1986|||APPR|
P820014|S024|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|02/14/1986|03/11/1986|||APPR|
P820014|S025|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|||N|03/26/1986|05/05/1986|||APPR|
P820014|S026|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/1986|10/20/1986|||APPR|
P820014|S027|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/1986|02/18/1987|||APPR|
P820014|S028|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Special (Immediate Track)|Other Report|N|10/16/1986|12/01/1986|||APPR|
P820014|S029|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/1986|02/03/1987|||APPR|
P820014|S030|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1987|04/03/1987|||APPR|
P820014|S031|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/1987|04/03/1987|||APPR|
P820014|S032|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1987|01/11/1988|||APPR|
P820014|S033|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Other Report|N|01/15/1988|04/06/1988|||APPR|
P820014|S034|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/1988|03/17/1988|||APPR|
P820014|S035|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1988|04/12/1988|||APPR|
P820014|S036|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/1988|07/28/1988|||APPR|
P820014|S037|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/14/1988|08/04/1988|||APPR|
P820014|S038|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/1988|07/21/1988|||APPR|
P820014|S039|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1988|12/12/1988|||APPR|
P820014|S041|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/1989|04/18/1989|||APPR|
P820014|S042|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/1989|03/22/1990|||APPR|
P820014|S043|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|CORDIS SEQUICOR THETA MODELS 233D & 233E|LWP|CV|Normal 180 Day Track|Other Report|N|01/16/1990|02/02/1990|||APPR|
P820014|S044|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|SEQUICOR SERIES PULSE GEN. MODELS 233F,233G,& 240G|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1990|05/09/1990|||APPR|
P820016|S002|CILCO, INC.|1616 13TH AVENUE  HUNTINGTON,|WEST VIRGINIA|||||intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P820017|S001|HYDRACON|718 PASEO MONTECITO||NEWBURY PARK|CA|91320||Lenses, soft contact, daily wear|HYDRACON(R) CONTACT LENSES|LPL|OP|||N|09/22/1982|08/16/1985||11/19/1985|APPR|
P820017|S002|HYDRACON|718 PASEO MONTECITO||NEWBURY PARK|CA|91320||Lenses, soft contact, daily wear|HYDRACON(R) CONTACT LENSES|LPL|OP|||N|08/16/1982|07/11/1984||08/07/1984|APPR|
P820017|S003|HYDRACON|718 PASEO MONTECITO||NEWBURY PARK|CA|91320||Lenses, soft contact, daily wear|HYDRACON(R) CONTACT LENSES|LPL|OP|||N|03/14/1983|04/28/1983|||APPR|
P820017|S004|HYDRACON|718 PASEO MONTECITO||NEWBURY PARK|CA|91320||Lenses, soft contact, daily wear|HYDRACON(R) CONTACT LENSES|LPL|OP|||N|03/14/1983|06/02/1983|||APPR|
P820017|S005|HYDRACON|718 PASEO MONTECITO||NEWBURY PARK|CA|91320||Lenses, soft contact, daily wear|HYDRACON(R) CONTACT LENSES|LPL|OP|||N|03/14/1983|04/28/1983|||APPR|
P820017|S008|HYDRACON|718 PASEO MONTECITO||NEWBURY PARK|CA|91320||Lenses, soft contact, daily wear|HYDRACON(R) CONTACT LENSES|LPL|OP|||N|11/16/1984|10/04/1985|||APPR|
P820017|S009|HYDRACON|718 PASEO MONTECITO||NEWBURY PARK|CA|91320||Lenses, soft contact, daily wear|HYDRACON(R) CONTACT LENSES|LPL|OP|||N|04/01/1985|10/30/1985|||APPR|
P820017|S012|HYDRACON|718 PASEO MONTECITO||NEWBURY PARK|CA|91320||Lenses, soft contact, daily wear|HYDRACON(R) CONTACT LENSES|LPL|OP|||N|08/20/1984|03/10/1986|||APPR|
P820018|S001|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|02/22/1983|06/06/1983|||APPR|
P820018|S005|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|03/28/1983|03/23/1984|||APPR|
P820018|S006|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|05/05/1983|06/03/1983|||APPR|
P820018|S009|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|06/13/1983|07/14/1983|||APPR|
P820018|S010|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|04/02/1984|05/21/1984|||APPR|
P820018|S011|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|04/12/1984|05/21/1984|||APPR|
P820018|S012|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|10/22/1984|04/18/1985|||APPR|
P820018|S013|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|11/30/1984|02/27/1985|||APPR|
P820018|S014|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|12/10/1984|04/18/1985|||APPR|
P820018|S016|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|05/08/1985|12/26/1985|||APPR|
P820018|S017|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|05/30/1985|12/27/1985|||APPR|
P820018|S018|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|06/13/1985|07/15/1985|||APPR|
P820018|S019|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|09/03/1985|10/01/1985|||APPR|
P820018|S020|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|11/27/1985|01/30/1986|||APPR|
P820018|S021|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|12/16/1985|01/28/1986|||APPR|
P820018|S022|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|12/31/1985|01/30/1986|||APPR|
P820018|S023|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|01/17/1986|09/26/1988|||APPR|
P820018|S024|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|02/26/1986|03/27/1986|||APPR|
P820018|S025|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|||N|02/26/1986|03/27/1986|||APPR|
P820018|S026|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1986|10/10/1986|||APPR|
P820018|S027|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1987|03/27/1987|||APPR|
P820018|S028|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/1988|07/25/1988|||APPR|
P820018|S029|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1988|01/27/1989|||APPR|
P820018|S031|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/1989|04/18/1989|||APPR|
P820018|S032|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/17/1989|08/08/1989|||APPR|
P820018|S033|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1989|09/13/1989|||APPR|
P820018|S034|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/1989|12/28/1989|||APPR|
P820018|S035|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA(TM) MODEL 2251 & MODEL 2600|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/1989|03/22/1990|||APPR|
P820018|S036|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|CETA DDD MODEL 1230 PACER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1989|06/12/1990|||APPR|
P820018|S039|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|META DDD MODEL 1230 PACER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1989|03/26/1991|||APPR|
P820018|S040|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/1989|08/29/1990|||APPR|
P820018|S041|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN|LWP|CV|Normal 180 Day Track|Other Report|N|01/16/1990|02/02/1990|||APPR|
P820018|S042|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/1990|09/17/1990|||APPR|
P820018|S043|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/1990|08/23/1990|||APPR|
P820018|S044|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1990|05/09/1990|||APPR|
P820018|S045|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|LEX MODEL 8220E SINGLE CHAMBER PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/29/1990|10/15/1990|||APPR|
P820018|S046|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA PACING SYSTEM (META DDD MODEL 1230)|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/12/1990|10/15/1990|||APPR|
P820018|S047|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|9600 NETWORK PROGRAMMER & X92 PULSE GEN. MODELS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/1990|11/13/1991|||APPR|
P820018|S048|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA MODELS 6291 AND 6292 PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/1991|03/14/1991|||APPR|
P820018|S049|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 5603 PROGRAMMER SOFTWARE, VP.11P.|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/22/1991|08/21/1991|||APPR|
P820018|S050|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1991|07/31/1991|||APPR|
P820018|S051|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|REFLEX MODEL 8223E DUAL CHAMBER PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1991|10/25/1991|||APPR|
P820018|S052|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA MODEL 2251 GENERATOR & MODEL 2600 PROGRAMME|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1991|10/25/1991|||APPR|
P820018|S053|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA MODEL 2251 GENERATOR & MODEL 2600 PROGRAMME|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1991|12/20/1991|||APPR|
P820018|S054|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA MODEL 6291,2,6 & META DDD MODEL 1230|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1991|12/06/1991|||APPR|
P820018|S055|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 5603 PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1991|11/20/1991|||APPR|
P820018|S056|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 5603,9600 PROGRAMMER NEW SOFTWARE,V4.10UE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1992|02/05/1993|||APPR|
P820018|S057|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 5603,9600 PROGRAMMER INTERFACE CABLE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/1992|04/19/1993|||APPR|
P820018|S058|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 9600 NETWORK PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1992|06/18/1993|||APPR|
P820018|S059|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA (TM) MODEL 2251,& 2600|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/1993|04/21/1993|||APPR|
P820018|S060|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA (TM) MODEL 2251,& 2600|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1993|02/24/1994|||APPR|
P820018|S061|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA/AURORA CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1993|07/12/1995|||APPR|APPROVAL FOR ADDITION OF NON-INVASIVE PROGRAMMED STIMULATION (NIPS)
P820018|S063|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA/AURORA CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/1994|07/23/1996|||APPR|APPROVAL FOR A CHANGE IN STERILIZATION CONTRACTOR. THE PROPOSED STERILIZATION CONTRACTOR IS:GRIFFITH MICRO SCIENCE, INC., 2973 OLYMPIC INDUSTRIAL DRIVE, SMYRNA, GA 30080-7322
P820018|S064|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|REFLEX MODEL 8223E|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/18/1994|08/30/1994|||APPR|
P820018|S065|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|REFLEX MODEL 8223E|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/1994|07/23/1996|||APPR|APPROVAL FOR A CHANGE IN STERILIZATION CONTRACTOR. THE PROPOSED STERILIZATION CONTRACTOR IS: GRIFFITH MICRO SCIENCE, INC. 2973 OLYMPIC INDUSTRIAL DRIVE, SMYRNA, GEORGIA 30080-7322
P820019|S002|BIOCHEM INTERNATIONAL, INC.|10238 N. 1650 ROCKWOOD DR.||WAUKESHA|WI|53186||MONITOR, CARBON-DIOXIDE, CUTANEOUS|LIFESPAN(TM) 100 TCPCO2 MONITOR|LKD|CV|||N|04/18/1983|05/26/1983|||APPR|
P820019|S003|BIOCHEM INTERNATIONAL, INC.|10238 N. 1650 ROCKWOOD DR.||WAUKESHA|WI|53186||MONITOR, CARBON-DIOXIDE, CUTANEOUS|LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE|LKD|CV|||N|05/08/1984|08/21/1985|||APPR|
P820019|S005|BIOCHEM INTERNATIONAL, INC.|10238 N. 1650 ROCKWOOD DR.||WAUKESHA|WI|53186||MONITOR, CARBON-DIOXIDE, CUTANEOUS|LIFESPAN(TM) 100 TCPCO2 MONITOR|LKD|CV|||N|12/11/1984|11/19/1985|||APPR|
P820019|S006|BIOCHEM INTERNATIONAL, INC.|10238 N. 1650 ROCKWOOD DR.||WAUKESHA|WI|53186||MONITOR, CARBON-DIOXIDE, CUTANEOUS|LIFESPAN(TM) 100 TCPCO2 MONITOR|LKD|CV|||N|02/15/1985|01/27/1986|||APPR|
P820019|S007|BIOCHEM INTERNATIONAL, INC.|10238 N. 1650 ROCKWOOD DR.||WAUKESHA|WI|53186||MONITOR, CARBON-DIOXIDE, CUTANEOUS|LIFESPAN(TM) 100 TCPCO2 MONITOR|LKD|CV|||N|01/17/1986|03/03/1986|||APPR|
P820021|S001|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON(R) (VIFILCONA)|LPM|OP|||N|06/07/1983|09/16/1983|||APPR|
P820021|S002|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON(R) (VIFILCONA)|LPM|OP|||N|05/17/1983|08/12/1983|||APPR|
P820021|S003|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON(R) (VIFILCONA)|LPM|OP|||N|01/10/1985|07/22/1985|||APPR|
P820021|S005|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|||N|02/05/1986|09/21/1987|||APPR|
P820021|S006|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|||N|03/07/1986|03/17/1986|||APPR|
P820021|S007|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|||N|03/04/1986|05/21/1986|||APPR|
P820021|S008|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|||N|03/18/1986|06/24/1986|||APPR|
P820021|S009|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1987|04/17/1987|||APPR|
P820021|S010|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/1987|07/11/1988|||APPR|
P820021|S012|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/1988|06/21/1988|||APPR|
P820021|S013|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/04/1988|09/14/1988|||APPR|
P820021|S014|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1988|01/23/1989|||APPR|
P820021|S015|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1988|08/14/1989|||APPR|
P820021|S016|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1989|05/03/1989|||APPR|
P820021|S017|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/16/1990|||APPR|
P820021|S018|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/1989|11/20/1989|||APPR|
P820021|S019|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/1989|04/11/1990|||APPR|
P820021|S021|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES|LPM|OP|Normal 180 Day Track|Other Report|N|03/28/1990|08/17/1990|||APPR|
P820021|S022|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/1990|01/14/1992|||APPR|
P820021|S023|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1991|08/06/1991|||APPR|
P820021|S024|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|NEWVUES(R) THERAPEUTIC(TM) (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1994|02/13/1995|||APPR|
P820022|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER|LWW|CV|||N|06/20/1985|07/29/1985|||APPR|
P820022|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER|LWW|CV|Normal 180 Day Track|Other Report|N|09/18/1989|02/16/1990|||APPR|
P820023|S002|PACESETTER SYSTEMS|12884 BRADLEY AVE.||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P|LWP|CV|||N|03/25/1983|05/03/1983|||APPR|
P820023|S003|PACESETTER SYSTEMS|12884 BRADLEY AVE.||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P|LWP|CV|||N|06/06/1983|08/10/1983|||APPR|
P820023|S004|PACESETTER SYSTEMS|12884 BRADLEY AVE.||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P|LWP|CV|||N|08/09/1983|11/21/1983|||APPR|
P820023|S005|PACESETTER SYSTEMS|12884 BRADLEY AVE.||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P|LWP|CV|||N|11/03/1983|02/23/1984|||APPR|
P820024|S001|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|||N|08/17/1982|03/16/1984|||APPR|
P820024|S002|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|||N|03/23/1984|04/11/1984|||APPR|
P820024|S003|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|||N|04/30/1984|11/08/1985|||APPR|
P820024|S004|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|||N|06/07/1984|05/13/1985|||APPR|
P820024|S005|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|||N|11/14/1984|05/13/1985|||APPR|
P820024|S007|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|||N|05/21/1986|07/10/1986|||APPR|
P820024|S008|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/1986|11/17/1986|||APPR|
P820024|S009|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Normal 180 Day Track|Other Report|N|12/12/1986|01/21/1987|||APPR|
P820024|S010|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Normal 180 Day Track|Other Report|N|12/15/1986|01/21/1987|||APPR|
P820024|S011|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|05/08/1987|10/06/1987|||APPR|
P820024|S012|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/1988|07/19/1988|||APPR|
P820024|S013|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/1989|12/05/1990|||APPR|
P820024|S014|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/1989|08/09/1990|||APPR|
P820024|S015|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/1990|04/02/1991|||APPR|
P820024|S016|DEPUY, INC.|PO BOX 988||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented|PROSTHESIS, HIP, HEMI-FEMORAL, METAL|LPF|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/1991|12/04/1991|||APPR|
P820025|S001|NARCO SCIENTIFIC|330 JACKSONVILLE RD.||HATBORO|PA|19040||MONITOR, CARBON-DIOXIDE, CUTANEOUS|TCPCO2 MONITORING SYSTEM|LKD|CV|||N|01/11/1984|04/18/1984|||APPR|
P820026|S001|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT|LPL|OP|||N|06/03/1985|10/25/1985|||APPR|
P820026|S002|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT|LPL|OP|||N|09/24/1985|04/13/1988|||APPR|
P820026|S003|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/1988|02/21/1989|||APPR|
P820026|S004|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1988|11/10/1988|||APPR|
P820026|S005|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1988|03/01/1989|||APPR|
P820026|S006|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1989|10/13/1989|||APPR|
P820026|S007|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/1989|01/31/1990|||APPR|
P820026|S008|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT|LPL|OP|Normal 180 Day Track|Other Report|N|07/23/1990|09/17/1990|||APPR|
P820027|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||System, identification, contact lens|SOFTMARK|LOH|OP|||N|08/04/1983|11/01/1983|||APPR|
P820027|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||System, identification, contact lens|SOFTMARK|LOH|OP|||N|06/13/1985|10/01/1985|||APPR|
P820031|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|||N|12/08/1983|11/01/1984|||APPR|
P820031|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|||N|02/01/1984|03/19/1984|||APPR|
P820031|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|||N|02/08/1984|01/29/1985|||APPR|
P820031|S005|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|||N|06/28/1984|09/09/1987|||APPR|
P820031|S006|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|||N|08/27/1984|04/03/1987|||APPR|
P820031|S007|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1987|05/29/1987|||APPR|
P820031|S008|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/23/1987|03/18/1988|88M-0128|06/01/1988|APPR|
P820031|S009|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1988|07/06/1988|||APPR|
P820031|S010|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/1988|09/26/1988|||APPR|
P820031|S011|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|0ENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/14/1989|02/06/1990|||APPR|
P820032|S001|FENWAL, INC.|THREE CORPORATE DRIVE||LAKE ZURICH|IL|60047||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PLASMA SEPARATION SYSTEM|LKN|GU|||N|11/22/1983|12/05/1983|||APPR|
P820032|S002|FENWAL, INC.|THREE CORPORATE DRIVE||LAKE ZURICH|IL|60047||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PLASMA SEPARATION SYSTEM|LKN|GU|||N|04/30/1984|06/13/1984|||APPR|
P820032|S003|FENWAL, INC.|THREE CORPORATE DRIVE||LAKE ZURICH|IL|60047||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PLASMA SEPARATION SYSTEM|LKN|GU|||N|05/07/1984|06/13/1984|||APPR|
P820032|S004|FENWAL, INC.|THREE CORPORATE DRIVE||LAKE ZURICH|IL|60047||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PLASMA SEPARATION SYSTEM|LKN|GU|||N|06/07/1985|07/09/1985|||APPR|
P820032|S005|FENWAL, INC.|THREE CORPORATE DRIVE||LAKE ZURICH|IL|60047||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PLASMA SEPARATION SYSTEM|LKN|GU|Normal 180 Day Track|Other Report|N|07/07/1987|08/25/1987|||APPR|
P820033|S001|Asahi Kasei Medical Co., Ltd.|1-105 KANDA JINBOCHO|CHIYODA-KU|TOKYO||101-8|8101|Separator for therapeutic purposes, membrane automated blood cell/plasma|PLASMAFLO AP-05H ASAHI PLASMA SEPARATOR|MDP|GU|||N|04/20/1984|01/08/1986|||APPR|
P820034|S001|REPRO-MED SYSTEMS, INC.|24 CARPENTER RD.||CHESTER|NY|10918||DEVICE, TESTICULAR HYPOTHERMIA|REPRO-MED - THD|LOA|GU|||N|01/09/1985|01/31/1985|||APPR|
P820034|S002|REPRO-MED SYSTEMS, INC.|24 CARPENTER RD.||CHESTER|NY|10918||DEVICE, TESTICULAR HYPOTHERMIA|REPRO-MED - THD|LOA|GU|||N|02/04/1985|05/12/1987|||APPR|
P820034|S003|REPRO-MED SYSTEMS, INC.|24 CARPENTER RD.||CHESTER|NY|10918||DEVICE, TESTICULAR HYPOTHERMIA|REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY|LOA|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/1992|04/28/1993|||APPR|
P820034|S004|REPRO-MED SYSTEMS, INC.|24 CARPENTER RD.||CHESTER|NY|10918||DEVICE, TESTICULAR HYPOTHERMIA|REPRO-MED - THD|LOA|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1992|04/29/1993|||APPR|
P820035|S008|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1987|11/03/1987|||APPR|
P820035|S009|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1987|05/03/1988|||APPR|
P820035|S010|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/1987|05/03/1988|||APPR|
P820035|S012|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P820036|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|||N|12/08/1983|02/06/1987|||APPR|
P820036|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|||N|01/10/1984|03/14/1985|||APPR|
P820036|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|||N|07/18/1984|06/07/1985|||APPR|
P820036|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|||N|07/17/1985|08/06/1985|||APPR|
P820036|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|||N|07/19/1985|10/16/1986|||APPR|
P820036|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/1987|12/13/1988|||APPR|
P820036|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1987|03/14/1988|||APPR|
P820036|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/21/1988|08/10/1989|||APPR|
P820036|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/1989|10/16/1989|||APPR|
P820036|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN(TM) LC 1323|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/1990|06/22/1990|||APPR|
P820036|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN DAILY CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/21/1990|10/05/1990|||APPR|
P820036|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN DAILY CLEANER|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P820040|S001|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|||N|03/24/1983|12/23/1983|||APPR|
P820040|S002|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|||N|01/03/1984|10/03/1984|||APPR|
P820040|S003|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|||N|07/17/1984|10/04/1985|||APPR|
P820040|S004|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|||N|08/30/1984|08/20/1985|||APPR|
P820040|S005|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|||N|05/02/1985|06/24/1985|||APPR|
P820040|S006|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|||N|05/20/1985|06/20/1986|||APPR|
P820040|S007|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|||N|09/30/1985|02/02/1989|||APPR|
P820040|S009|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Other Report|N|10/15/1985|07/30/1987|||APPR|
P820040|S010|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|||N|02/26/1986|05/05/1986|||APPR|
P820040|S011|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/1986|07/31/1986|||APPR|
P820040|S012|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|THIRTY DAY TRACK|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/1986|04/08/1987|||APPR|
P820040|S013|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1987|05/22/1987|||APPR|
P820040|S014|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/1987|09/30/1987|||APPR|
P820040|S015|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/1987|08/14/1987|||APPR|
P820040|S016|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1987|09/30/1987|||APPR|
P820040|S017|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1987|12/30/1987|||APPR|
P820040|S019|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|01/27/1988|05/06/1988|||APPR|
P820040|S020|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/1988|05/26/1989|||APPR|
P820040|S021|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1988|11/22/1989|||APPR|
P820040|S022|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/1988|03/02/1989|||APPR|
P820040|S023|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/1989|04/20/1989|||APPR|
P820040|S025|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/1989|12/06/1989|||APPR|
P820040|S026|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/1990|08/08/1991|||APPR|
P820040|S027|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|AOSEPT(R) & LENSEPT(R) SOLUTIONS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/1990|06/03/1991|||APPR|
P820040|S029|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|AOSEPT(R) & LENSEPT(R) SOLUTIONS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1990|02/04/1991|||APPR|
P820040|S030|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|OSEPT(R) & LENSEPT(R) SOLUTIONS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/03/1991|09/30/1994|||APPR|
P820040|S031|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|LENSEPT(R) DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1991|12/10/1991|||APPR|
P820040|S032|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|AOSEPT (R) LENS CUP & AODISC NEUTRALIZER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1994|10/23/1995|||APPR|APPROVAL FOR MODIFICATIONS TO THE CURRENTLY APPROVED AOSEPT LENS CUP AND AODISC NEUTRALIZER TO INLCUDE A CUP MANUFACTURING SITE CHANGE, CUP MATERIAL CHANGE, CUP AND DISC DESIGN CHANGE, AND CORRESPONDING LABELING CHANGES.  THE NEW PRIMARY MANUFACTURING SITE IS TENAX CORPORATION, 124 FRANKLIN PARK AVENUE, YOUNGSVILLE, NC 27596.  SECONDARY MANUFACTURING SITE IS TENAX CORP, 2450 LAURA DUNCAN ROAD, APEX, NC 27502
P820044|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL 91-50 IOL|HQL|OP|||N|02/27/1984|01/08/1986|||APPR|
P820044|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL 91-50 IOL|HQL|OP|||N|01/30/1986|02/21/1986|||APPR|
P820044|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL 91-50 IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1989|03/19/1990|||APPR|
P820049|S001|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|03/05/1984|10/03/1985|||APPR|
P820049|S002|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|06/21/1984|09/30/1985|||APPR|
P820049|S003|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|07/15/1985|03/11/1986|||APPR|
P820049|S004|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|11/18/1985|03/31/1986|||APPR|
P820049|S005|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|11/25/1985|02/19/1986|||APPR|
P820049|S006|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|12/23/1985|07/01/1986|||APPR|
P820049|S007|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|02/28/1986|03/07/1986|||APPR|
P820049|S008|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|03/28/1986|09/24/1986|||APPR|
P820049|S009|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|||N|04/24/1986|07/01/1986|||APPR|
P820049|S010|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1986|10/15/1986|||APPR|
P820049|S011|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1986|11/18/1986|||APPR|
P820049|S012|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/1986|02/06/1987|||APPR|
P820049|S013|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/06/1986|01/13/1987|||APPR|
P820049|S014|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1986|05/20/1987|||APPR|
P820049|S015|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1986|05/22/1987|||APPR|
P820049|S016|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1986|02/11/1987|||APPR|
P820049|S017|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/1986|01/13/1987|||APPR|
P820049|S018|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1986|05/19/1987|||APPR|
P820049|S019|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1987|09/21/1987|||APPR|
P820049|S020|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/1987|12/30/1987|||APPR|
P820049|S021|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/1987|07/16/1987|||APPR|
P820049|S022|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/28/1987|11/24/1987|||APPR|
P820049|S023|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1987|12/07/1987|||APPR|
P820049|S024|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Other Report|N|06/24/1987|12/21/1987|||APPR|
P820049|S025|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/1987|03/14/1988|||APPR|
P820049|S026|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/1987|01/11/1988|||APPR|
P820049|S027|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/1987|02/19/1988|||APPR|
P820049|S028|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/1987|01/13/1988|||APPR|
P820049|S029|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Other Report|N|08/28/1987|02/23/1988|||APPR|
P820049|S031|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/1987|03/07/1988|||APPR|
P820049|S032|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/13/1987|03/23/1988|||APPR|
P820049|S033|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1987|11/18/1988|||APPR|
P820049|S034|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/29/1988|06/24/1988|||APPR|
P820049|S035|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Other Report|N|02/29/1988|04/27/1988|||APPR|
P820049|S036|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/1988|08/16/1988|||APPR|
P820049|S037|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1988|02/27/1989|||APPR|
P820049|S038|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1988|11/21/1988|||APPR|
P820049|S039|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/10/1988|02/14/1989|||APPR|
P820049|S042|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/1988|11/29/1989|||APPR|
P820049|S043|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1988|11/03/1989|||APPR|
P820049|S044|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1988|11/14/1989|||APPR|
P820049|S045|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1989|08/10/1989|||APPR|
P820049|S046|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1989|08/10/1989|||APPR|
P820049|S047|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC10 & PC21|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1989|08/10/1989|||APPR|
P820049|S048|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-40NJB (TIER)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/1989|05/23/1990|||APPR|
P820049|S049|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-40NJB (TIER)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/1990|06/15/1990|||APPR|
P820049|S050|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-38NB  (TIER)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/1990|11/15/1990|||APPR|
P820049|S051|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-36CNB (TIER A)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1990|06/20/1991|||APPR|
P820049|S052|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|POSTERIOR CHAMBER MONOFOCAL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/1991|02/21/1991|||APPR|
P820049|S053|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODIFIED J & C LLOP POST. CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/1991|08/11/1993|||APPR|
P820049|S054|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-10 POST CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1992|11/09/1992|||APPR|
P820049|S055|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-10 POST CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1992|11/09/1992|||APPR|
P820049|S056|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-42ANB POSTERIOR IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1993|08/04/1994|||APPR|
P820049|S057|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC-43,44,45 NB UV ABSORBING IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/1993|10/04/1994|||APPR|
P820049|S058|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC-52ANB,PC-53ANB,PC-53ATB,PC-54ANB IOL'S|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/1993|08/09/1994|||APPR|
P820049|S059|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PS-100A,PS-101A,PS-102A,PS-103A,PS-104A IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1993|06/01/1995|||APPR|
P820050|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|10/18/1983|12/08/1983|||APPR|
P820050|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|10/18/1983|12/08/1983|||APPR|
P820050|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|04/02/1984|03/29/1985|||APPR|
P820050|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|04/30/1984|03/05/1985|||APPR|
P820050|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|04/30/1984|02/15/1985|||APPR|
P820050|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|09/05/1984|06/07/1985|||APPR|
P820050|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|09/05/1984|05/31/1985|||APPR|
P820050|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|09/05/1984|05/16/1985|||APPR|
P820050|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|05/16/1985|10/01/1985|||APPR|
P820050|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|05/16/1985|09/20/1985|||APPR|
P820050|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|04/15/1985|09/20/1985|||APPR|
P820050|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|07/23/1985|03/27/1987|||APPR|
P820050|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|||N|05/24/1985|10/03/1985|||APPR|
P820050|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/1987|09/09/1987|||APPR|
P820050|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/1987|06/16/1987|||APPR|
P820050|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1987|04/08/1987|||APPR|
P820050|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/1987|04/14/1988|||APPR|
P820050|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/1989|04/05/1989|||APPR|
P820050|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
P820051|S002|OCU-EASE OPTICAL PRODUCTS, INC.|629 TENNENT AVE.||PINOLE|CA|94564||Lenses, soft contact, daily wear|OCU-FLEX|LPL|OP|||N|08/05/1985|02/20/1986|||APPR|
P820051|S003|OCU-EASE OPTICAL PRODUCTS, INC.|629 TENNENT AVE.||PINOLE|CA|94564||Lenses, soft contact, daily wear|OCU-FLEX|LPL|OP|Normal 180 Day Track||N|06/03/1986|09/29/1986|||APPR|
P820051|S008|OCU-EASE OPTICAL PRODUCTS, INC.|629 TENNENT AVE.||PINOLE|CA|94564||Lenses, soft contact, daily wear|STERILIZED FINISHED OCUFILCON B LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/07/1988|09/19/1988|||APPR|
P820051|S009|OCU-EASE OPTICAL PRODUCTS, INC.|629 TENNENT AVE.||PINOLE|CA|94564||Lenses, soft contact, daily wear|STERILIZED FINISHED OCUFILCON B LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/22/1989|08/22/1991|||APPR|
P820051|S010|OCU-EASE OPTICAL PRODUCTS, INC.|629 TENNENT AVE.||PINOLE|CA|94564||Lenses, soft contact, daily wear|STERILIZED FINISHED OCUFILCON B LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/1989|06/28/1990|||APPR|
P820051|S012|OCU-EASE OPTICAL PRODUCTS, INC.|629 TENNENT AVE.||PINOLE|CA|94564||Lenses, soft contact, daily wear|CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/1989|02/15/1991|||APPR|
P820051|S014|OCU-EASE OPTICAL PRODUCTS, INC.|629 TENNENT AVE.||PINOLE|CA|94564||Lenses, soft contact, daily wear|OCU-FLEX-53 SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/1991|09/11/1992|||APPR|
P820051|S015|OCU-EASE OPTICAL PRODUCTS, INC.|629 TENNENT AVE.||PINOLE|CA|94564||Lenses, soft contact, daily wear|PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/18/1992|02/26/1993|||APPR|
P820052|S001|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|||N|11/29/1983|02/08/1984|||APPR|
P820052|S002|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|||N|11/29/1983|02/08/1984|||APPR|
P820052|S003|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|||N|12/08/1983|02/08/1984|||APPR|
P820052|S004|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|||N|12/08/1983|02/08/1984|||APPR|
P820052|S005|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|||N|06/15/1984|03/26/1985|||APPR|
P820052|S006|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|||N|01/22/1985|03/26/1985|||APPR|
P820052|S007|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|||N|04/15/1985|07/23/1985|||APPR|
P820052|S008|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||KIT, ASSAY, PROGESTERONE RECEPTOR|RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT|LPI|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/15/1991|08/06/1991|||APPR|
P820053|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|||N|03/22/1984|04/23/1986|||APPR|
P820053|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|||N|05/15/1985|10/01/1986|||APPR|
P820053|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|||N|08/12/1985|01/10/1986|||APPR|
P820053|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|||N|01/21/1986|04/16/1986|||APPR|
P820053|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1986|12/01/1986|||APPR|
P820053|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/05/1987|04/04/1988|||APPR|
P820053|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/1987|08/12/1987|||APPR|
P820053|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/1987|08/14/1987|||APPR|
P820053|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/1988|11/29/1988|||APPR|
P820053|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/1989|05/02/1989|||APPR|
P820053|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/1989|12/31/1992|||APPR|
P820053|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/1989|11/07/1989|||APPR|
P820053|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/1989|11/21/1989|||APPR|
P820053|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1990|06/05/1990|||APPR|
P820053|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/1990|05/28/1991|||APPR|
P820053|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE REGIMEN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1990|04/13/1994|||APPR|
P820053|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/03/1992|05/21/1992|||APPR|
P820053|S021|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/1992|05/18/1993|||APPR|
P820053|S022|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/1992|07/28/1993|||APPR|
P820056|S001|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL K|HQD|OP|||N|05/11/1983|10/31/1985|||APPR|
P820056|S002|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|08/08/1983|01/05/1984|||APPR|
P820056|S003|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|11/03/1983|08/07/1986|||APPR|
P820056|S005|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|01/20/1984|06/08/1984|||APPR|
P820056|S006|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|05/03/1984|02/15/1985|||APPR|
P820056|S007|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|09/17/1984|02/15/1985|||APPR|
P820056|S009|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|05/02/1985|10/10/1985|||APPR|
P820056|S010|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL II BLUE|HQD|OP|||N|08/19/1985|12/06/1985|||APPR|
P820056|S011|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 VIOLET CONTACT LENS|HQD|OP|||N|08/19/1985|11/02/1987|||APPR|
P820056|S012|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track||N|12/27/1985|03/31/1986|||APPR|
P820056|S013|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track||N|02/11/1986|06/12/1986|||APPR|
P820056|S014|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|04/01/1986|06/20/1986|||APPR|
P820056|S016|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|04/16/1986|06/24/1986|||APPR|
P820056|S017|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|04/29/1986|07/01/1986|||APPR|
P820056|S018|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|||N|05/06/1986|08/04/1986|||APPR|
P820056|S020|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Other Report|N|09/05/1986|10/01/1986|||APPR|
P820056|S021|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1986|05/26/1987|||APPR|
P820056|S022|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Other Report|N|11/17/1986|12/04/1986|||APPR|
P820056|S023|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Other Report|N|12/29/1986|03/14/1988|||APPR|
P820056|S024|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1987|01/28/1988|||APPR|
P820056|S025|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Other Report|N|02/02/1987|05/05/1987|||APPR|
P820056|S026|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Other Report|N|01/05/1987|03/24/1987|||APPR|
P820056|S027|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Other Report|N|04/06/1987|05/05/1987|||APPR|
P820056|S029|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Other Report|N|06/09/1987|07/23/1987|||APPR|
P820056|S030|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Other Report|N|08/31/1987|09/21/1987|||APPR|
P820056|S031|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/1987|02/04/1988|||APPR|
P820056|S032|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/1987|05/05/1988|||APPR|
P820056|S035|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/1988|03/17/1988|||APPR|
P820056|S036|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1988|09/30/1988|||APPR|
P820056|S037|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/1988|10/03/1988|||APPR|
P820056|S041|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1988|07/28/1988|||APPR|
P820056|S042|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/1988|07/28/1988|||APPR|
P820056|S043|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/1989|09/22/1989|||APPR|
P820056|S044|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1989|11/02/1989|||APPR|
P820056|S045|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1989|01/31/1990|||APPR|
P820056|S046|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/1989|01/16/1990|||APPR|
P820056|S047|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1990|05/07/1990|||APPR|
P820056|S048|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/1991|08/07/1991|||APPR|
P820056|S049|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 - CLEAR|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1991|08/15/1991|||APPR|
P820056|S050|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1992|02/25/1992|||APPR|
P820056|S051|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 (KOLFOCON A)RGP BROWN TINT|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|06/11/1992|||APPR|
P820056|S052|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/1992|03/30/1992|||APPR|
P820056|S053|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/1992|11/25/1992|||APPR|
P820056|S054|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/1993|04/14/1993|||APPR|
P820056|S055|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/04/1994|||APPR|
P820056|S056|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/04/1994|||APPR|
P820059|S001|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|10/21/1983|01/26/1984|||APPR|
P820059|S002|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|03/15/1984|12/10/1984|||APPR|
P820059|S003|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|04/26/1984|10/05/1984|||APPR|
P820059|S004|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|06/07/1984|10/23/1985|||APPR|
P820059|S005|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|09/04/1984|05/02/1986|||APPR|
P820059|S006|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|09/04/1984|11/30/1984|||APPR|
P820059|S007|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|06/19/1985|10/04/1985|||APPR|
P820059|S008|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|06/07/1984|01/27/1986||03/14/1986|APPR|
P820059|S009|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|||N|08/12/1985|01/27/1986||03/26/1986|APPR|
P820059|S010|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1986|08/04/1986|||APPR|
P820059|S011|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|Normal 180 Day Track|Other Report|N|08/05/1986|11/12/1986|||APPR|
P820059|S012|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/1986|01/29/1987|||APPR|
P820059|S013|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1987|05/26/1987|||APPR|
P820059|S015|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/23/1990|||APPR|
P820059|S016|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|PERMATINT(R)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/1989|09/18/1989|||APPR|
P820059|S018|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|POLYMACON CONTACT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/1991|03/05/1992|||APPR|
P820059|S019|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|POLYMACON CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/1992|09/30/1993|||APPR|
P820059|S020|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lenses, soft contact, daily wear|POLYMACON CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/1992|11/23/1993|||APPR|
P820060|S001|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER|LOJ|IM|||N|07/06/1983|08/31/1983|||APPR|
P820060|S002|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER|LOJ|IM|||N|02/21/1984|05/07/1985|||APPR|
P820060|S003|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER|LOJ|IM|||N|05/15/1986|03/09/1987|||APPR|
P820060|S004|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1988|05/09/1989|||APPR|
P820060|S005|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT COMMANDER(R) PPC AFP-EIA|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1990|08/21/1990|||APPR|
P820060|S006|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT IMX AFP ADDITIONAL PURIFICATION STEP|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1992|07/01/1993|||APPR|
P820060|S007|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AFP-EIA LABELING CHANGE|LOJ|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/1993|05/13/1993|||APPR|
P820060|S008|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AXSYM AFP (LIST 7A48)|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1994|03/27/1995|||APPR|
P820061|S001|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS CLEAR & BLUE|HPX|OP|||N|07/31/1984|12/06/1985|||APPR|
P820061|S002|DUPONT LEGAL|4417 LANCASTER PIKE||WILMINGTON|DE|19805||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS CLEAR & BLUE|HPX|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1989|08/28/1990|||APPR|
P820062|S001|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lens, contact (other material) - daily|PARAPERM O2 CLEAR & BLUE LENS|HQD|OP|||N|02/23/1984|03/16/1984|||APPR|
P820063|S001|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|11/29/1983|01/09/1984|||APPR|
P820063|S002|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|11/04/1983|12/23/1983|||APPR|
P820063|S004|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|03/12/1984|05/19/1987|||APPR|
P820063|S005|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|03/13/1984|06/04/1984|||APPR|
P820063|S006|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|03/30/1984|05/22/1987|||APPR|
P820063|S007|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track||N|06/04/1984|09/19/1985|||APPR|
P820063|S008|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|06/01/1984|05/03/1985|||APPR|
P820063|S009|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|07/18/1984|06/05/1985|||APPR|
P820063|S010|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|07/20/1984|06/05/1985|||APPR|
P820063|S011|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|12/12/1984|06/05/1985|||APPR|
P820063|S012|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|01/31/1985|06/03/1985|||APPR|
P820063|S013|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|02/08/1985|03/09/1987|||APPR|
P820063|S014|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|||N|04/17/1985|10/03/1985|||APPR|
P820063|S015|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Other Report|N|06/09/1986|05/22/1987|||APPR|
P820063|S016|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1986|06/24/1986|||APPR|
P820063|S017|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Other Report|N|04/09/1987|05/08/1987|||APPR|
P820063|S018|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Other Report|N|05/22/1987|06/16/1987|||APPR|
P820063|S019|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Other Report|N|06/04/1987|06/16/1987|||APPR|
P820063|S020|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Other Report|N|08/25/1987|09/21/1987|||APPR|
P820063|S022|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/1987|12/17/1987|||APPR|
P820063|S024|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1987|04/06/1988|||APPR|
P820063|S025|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1987|04/06/1988|||APPR|
P820063|S028|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1988|05/09/1988|||APPR|
P820063|S030|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/1988|05/05/1988|||APPR|
P820063|S032|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/1988|09/26/1988|||APPR|
P820063|S035|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/1988|08/09/1988|||APPR|
P820063|S036|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/1988|08/09/1988|||APPR|
P820063|S037|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/1988|11/28/1988|||APPR|
P820063|S038|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/1989|02/21/1989|||APPR|
P820063|S039|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1989|05/31/1989|||APPR|
P820063|S040|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/1989|12/28/1989|||APPR|
P820063|S041|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/1989|01/16/1990|||APPR|
P820063|S042|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/1989|11/21/1989|||APPR|
P820063|S043|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/1990|03/15/1990|||APPR|
P820063|S044|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1990|05/10/1990|||APPR|
P820063|S045|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/1990|06/07/1990|||APPR|
P820063|S046|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/1990|07/23/1990|||APPR|
P820063|S047|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/1990|10/31/1990|||APPR|
P820063|S048|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/1990|02/05/1991|||APPR|
P820063|S049|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1991|08/15/1991|||APPR|
P820063|S050|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1992|02/20/1992|||APPR|
P820063|S051|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) BROWN ,GRAY TINT|HPX|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|06/11/1992|||APPR|
P820063|S052|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/1992|03/30/1992|||APPR|
P820063|S053|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/1993|04/14/1993|||APPR|
P820063|S054|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/04/1994|||APPR|
P820063|S055|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (polymethylmethacrylate)|PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/04/1994|||APPR|
P820065|S001|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|09/15/1983|12/23/1983|||APPR|
P820065|S005|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|03/12/1984|07/18/1984|||APPR|
P820065|S006|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|04/30/1984|06/15/1984|||APPR|
P820065|S007|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|05/22/1984|02/28/1985|||APPR|
P820065|S008|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|05/22/1984|11/12/1985|||APPR|
P820065|S009|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|05/11/1984|02/28/1985|||APPR|
P820065|S010|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|06/14/1984|01/31/1985|||APPR|
P820065|S011|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|07/02/1984|03/01/1985|||APPR|
P820065|S012|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|AQUAFLEX(R) HGP(TM) RIGID GAS PERMEABLE LENSES|HPX|OP|||N|08/20/1984|03/05/1985|||APPR|
P820065|S013|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|10/05/1984|03/01/1985|||APPR|
P820065|S014|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|10/09/1984|03/01/1985|||APPR|
P820065|S015|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|12/17/1984|03/01/1985|||APPR|
P820065|S016|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|02/04/1985|07/22/1985|||APPR|
P820065|S017|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|02/04/1985|07/25/1985|||APPR|
P820065|S018|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|02/15/1985|07/25/1985|||APPR|
P820065|S019|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|03/27/1985|07/25/1985|||APPR|
P820065|S020|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|04/09/1985|07/25/1985|||APPR|
P820065|S021|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|05/07/1985|08/11/1986|||APPR|
P820065|S022|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|06/21/1985|08/05/1985|||APPR|
P820065|S023|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|08/07/1985|10/10/1985|||APPR|
P820065|S025|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|09/09/1985|12/15/1986|||APPR|
P820065|S026|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|10/10/1985|12/15/1986|||APPR|
P820065|S027|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|10/25/1985|05/26/1987|||APPR|
P820065|S028|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|12/19/1985|12/15/1986|||APPR|
P820065|S030|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|01/29/1986|04/25/1986|||APPR|
P820065|S032|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|03/18/1986|12/04/1986|||APPR|
P820065|S033|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|||N|05/20/1986|06/27/1986|||APPR|
P820065|S034|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/1986|07/01/1986|||APPR|
P820065|S035|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/1986|07/31/1986|||APPR|
P820065|S036|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Other Report|N|08/12/1986|09/29/1986|||APPR|
P820065|S038|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|10/28/1986|11/18/1986|||APPR|
P820065|S039|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|11/04/1986|12/01/1986|||APPR|
P820065|S042|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/1987|07/31/1987|||APPR|
P820065|S043|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|05/06/1987|06/16/1987|||APPR|
P820065|S044|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|07/14/1987|08/10/1987|||APPR|
P820065|S045|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Other Report|N|07/21/1987|08/05/1987|||APPR|
P820065|S047|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/1987|09/17/1987|||APPR|
P820065|S048|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|08/07/1987|09/21/1987|||APPR|
P820065|S049|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Other Report|N|09/18/1987|10/30/1987|||APPR|
P820065|S051|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/1988|03/17/1988|||APPR|
P820065|S052|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Other Report|N|02/03/1988|03/17/1988|||APPR|
P820065|S053|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/1988|04/06/1988|||APPR|
P820065|S054|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/12/1988|11/03/1988|||APPR|
P820065|S055|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1988|07/21/1988|||APPR|
P820065|S056|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/1988|07/21/1988|||APPR|
P820065|S057|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1988|08/08/1988|||APPR|
P820065|S058|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/1988|08/22/1988|||APPR|
P820065|S059|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|10/27/1988|12/12/1988|||APPR|
P820065|S060|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/1988|12/13/1988|||APPR|
P820065|S061|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1989|09/19/1989|||APPR|
P820065|S062|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/1989|09/19/1989|||APPR|
P820065|S063|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/1989|10/10/1989|||APPR|
P820065|S064|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1989|02/09/1990|||APPR|
P820065|S065|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS(R) LENS - CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/1989|02/28/1990|||APPR|
P820065|S066|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/1990|03/29/1990|||APPR|
P820065|S067|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/1990|03/29/1990|||APPR|
P820065|S068|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1990|03/29/1990|||APPR|
P820065|S070|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1990|06/25/1990|||APPR|
P820065|S071|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/1990|10/24/1990|||APPR|
P820065|S072|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1990|12/12/1990|||APPR|
P820065|S073|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/1990|02/04/1991|||APPR|
P820065|S074|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/1991|03/21/1991|||APPR|
P820065|S075|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/1991|04/05/1991|||APPR|
P820065|S076|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/1992|01/14/1992|||APPR|
P820065|S077|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/1992|02/20/1992|||APPR|
P820065|S078|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/1992|04/06/1992|||APPR|
P820065|S079|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1992|08/06/1992|||APPR|
P820065|S080|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV|HPX|OP|Normal 180 Day Track|Other Report|N|08/02/1993|09/07/1993|||APPR|
P820065|S081|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV|HPX|OP|Normal 180 Day Track|Other Report|N|08/02/1993|09/07/1993|||APPR|
P820065|S082|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Lens, contact (polymethylmethacrylate)|BOSTON LENS II & IV|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/1994|02/16/1994|||APPR|
P820069|S001|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|||N|12/22/1983|03/16/1984|||APPR|
P820069|S002|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|B&L CONCENTRATED CLEANER|LPN|OP|||N|02/07/1984|02/01/1985|||APPR|
P820069|S003|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|||N|02/07/1984|03/24/1988|||APPR|
P820069|S004|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|||N|02/15/1984|09/25/1984|||APPR|
P820069|S005|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|||N|03/27/1984|02/05/1985|||APPR|
P820069|S006|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|||N|04/23/1984|07/31/1985|||APPR|
P820069|S007|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|||N|07/10/1984|05/15/1985|||APPR|
P820069|S008|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|||N|08/16/1984|05/15/1985|||APPR|
P820069|S010|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|THIRTY DAY TRACK|Other Report|N|09/17/1987|10/27/1987|||APPR|
P820069|S011|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/1988|06/21/1988|||APPR|
P820069|S012|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/1989|07/13/1990|||APPR|
P820069|S013|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|BOSTON LENS(R) CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/1994|08/15/1994|||APPR|
P820070|S001|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|||N|12/22/1983|06/13/1984|||APPR|
P820070|S002|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|B & L WETTING/SOAKING SOLUTION|LPN|OP|||N|02/07/1984|02/01/1985|||APPR|
P820070|S003|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|||N|02/07/1984|03/24/1988|||APPR|
P820070|S004|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|||N|02/15/1984|03/29/1984|||APPR|
P820070|S005|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|||N|03/27/1984|02/05/1985|||APPR|
P820070|S006|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|||N|04/23/1984|11/02/1984|||APPR|
P820070|S007|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|||N|05/22/1984|10/10/1985|||APPR|
P820070|S008|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|||N|07/10/1984|06/07/1985|||APPR|
P820070|S009|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|||N|08/16/1984|06/10/1985|||APPR|
P820070|S011|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/1986|12/01/1987|||APPR|
P820070|S012|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/1987|12/01/1987|||APPR|
P820070|S013|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/1988|06/21/1988|||APPR|
P820070|S014|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/1988|06/01/1989|||APPR|
P820070|S015|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Accessories, soft lens products|BOSTON LENS(R) CONDITIONING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/1989|07/13/1990|||APPR|
P820072|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track||N|12/20/1983|06/28/1985|||APPR|
P820072|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|11/20/1984|07/10/1985|||APPR|
P820072|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|03/08/1985|07/25/1985|||APPR|
P820072|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|03/29/1985|10/09/1985|||APPR|
P820072|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|05/02/1985|06/13/1985|||APPR|
P820072|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|06/04/1985|07/10/1985|||APPR|
P820072|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|09/13/1985|03/03/1986|||APPR|
P820072|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track||N|10/18/1985|02/28/1986|||APPR|
P820072|S011|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|12/10/1985|01/08/1986|||APPR|
P820072|S012|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|12/10/1985|01/08/1986|||APPR|
P820072|S013|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|||N|04/16/1986|06/13/1986|||APPR|
P820072|S014|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1986|12/23/1986|||APPR|
P820072|S017|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/1987|12/07/1987|||APPR|
P820072|S018|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/1987|02/16/1989|||APPR|
P820072|S020|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1987|12/29/1989|||APPR|
P820072|S021|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/1988|05/09/1988|||APPR|
P820072|S022|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|03/28/1988|08/21/1989|89M-0362|11/13/1989|APPR|
P820072|S023|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/1988|03/02/1989|||APPR|
P820072|S024|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/22/1988|10/03/1988|||APPR|
P820072|S025|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1988|10/12/1989|||APPR|
P820072|S026|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1988|09/27/1989|||APPR|
P820072|S027|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/1988|11/20/1989|||APPR|
P820072|S028|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1988|11/20/1989|||APPR|
P820072|S029|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1988|11/27/1989|||APPR|
P820072|S031|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1989|03/19/1990|||APPR|
P820072|S032|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1989|03/19/1990|||APPR|
P820072|S033|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1989|12/11/1989|||APPR|
P820072|S034|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1989|12/13/1989|||APPR|
P820072|S035|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1989|09/28/1990|||APPR|
P820074|S001|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (other material) - daily|OPUS - III CONTACT LENSES|HQD|OP|||N|09/09/1983|11/17/1983|||APPR|
P820074|S002|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (other material) - daily|OPUS - III CONTACT LENSES|HQD|OP|||N|03/01/1984|06/25/1984|||APPR|
P820074|S003|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (other material) - daily|OPUS - III CONTACT LENSES|HQD|OP|||N|05/01/1984|06/08/1984|||APPR|
P820074|S004|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (other material) - daily|OPUS - III CONTACT LENSES|HQD|OP|||N|07/27/1984|06/25/1985|||APPR|
P820074|S006|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (other material) - daily|OPUS - III CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/1987|06/29/1988|||APPR|
P820075|S001|Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL(TM)|LOB|OB|||N|12/03/1984|02/12/1985|||APPR|
P820075|S002|Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL(TM)|LOB|OB|||N|12/03/1984|08/22/1986|||APPR|
P820075|S004|Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL(TM)|LOB|OB|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1988|05/24/1988|||APPR|
P820075|S005|Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL(R) OSSMOTIC CERVICAL DILATOR|LOB|OB|Normal 180 Day Track||N|07/05/1991|10/09/1991|||APPR|
P820076|S001|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 03|LWP|CV|||N|10/22/1984|02/12/1986|||APPR|
P820076|S002|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 03|LWP|CV|||N|02/20/1985|11/21/1985|||APPR|
P820076|S003|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 03|LWP|CV|||N|06/10/1985|03/06/1986|||APPR|
P820076|S004|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 03|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/1987|05/17/1988|||APPR|
P820076|S005|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 03|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1988|09/09/1988|||APPR|
P820076|S006|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 03|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/1988|02/22/1989|||APPR|
P820076|S007|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 03|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1989|12/04/1989|||APPR|
P820076|S008|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DIPLOS MODEL 03|LWP|CV|Normal 180 Day Track|Other Report|N|12/07/1989|01/18/1990|||APPR|
P820076|S009|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|SOFTWARE RELEASE NUMBER 2.4 4.31|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/1990|06/13/1990|||APPR|
P820076|S010|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|GEMNOS (TM) CARDIAC PACEMAKER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1990|07/26/1991|||APPR|
P820076|S011|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|GEMNOS (TM) CARDIAC PACEMAKER (4.34)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/1991|12/20/1991|||APPR|
P820076|S012|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|PMS-600 PROGRAMMER|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/06/1991|06/17/1991|||APPR|
P820076|S013|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|PMS-600 PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/1991|02/07/1992|||APPR|
P820076|S014|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|GEMNOS(TM) 04 CARDIAC PACEMAKER & SWN 600/C00U02|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1991|02/09/1993|||APPR|
P820076|S015|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|GEMNOS(TM)04A CARDIAC PACEMAKER & SWM 600/C00U02|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/1993|12/08/1993|||APPR|
P820076|S016|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|GEMNOS TC 04 PULSE GENERATOR & SOFTWARE MODULE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/1993|09/19/1994|||APPR|
P820076|S017|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/1994|09/07/1995|||APPR|APPROVAL FOR THE SWM 600 VERSION DO5U01 SOFTWARE MODULE FOR USE WITH THE MODEL PMS 600 PROGRAMMER
P820082|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Sterilizer, soft-lens, thermal, ac-powered|THE SOFT LENS THERMAL DISINFECTING UNIT|HRD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1987|08/27/1987|||APPR|
P820082|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Sterilizer, soft-lens, thermal, ac-powered|THE SOFT LENS THERMAL DISINFECTING UNIT|HRD|OP|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|06/25/1987|07/31/1987|||APPR|
P820082|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Sterilizer, soft-lens, thermal, ac-powered|LENS PLUS COMPACT HEAT UNIT|HRD|OP|Normal 180 Day Track|Other Report|N|02/15/1990|10/28/1991|||APPR|
P820083|S001|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|||N|04/08/1986|05/12/1986|||APPR|
P820083|S002|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|||N|05/02/1986|06/05/1986|||APPR|
P820083|S003|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|||N|05/23/1986|06/09/1986|||APPR|
P820083|S004|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1986|08/05/1986|||APPR|
P820083|S005|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/1987|07/31/1987|||APPR|
P820083|S006|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/1987|12/14/1987|||APPR|
P820083|S007|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Other Report|N|09/26/1988|03/09/1989|||APPR|
P820083|S008|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1988|05/02/1989|||APPR|
P820083|S009|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1988|03/09/1989|||APPR|
P820083|S010|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/1989|05/26/1989|||APPR|
P820083|S012|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Other Report|N|08/17/1990|10/19/1990|||APPR|
P820083|S013|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/1991|07/01/1993|||APPR|
P820083|S014|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1992|10/15/1993|||APPR|
P820083|S015|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) EXPANDED PTFE SUTURE|GAW|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/22/1993|04/08/1994|||APPR|
P820083|S016|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) SUTURE|GAW|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/1993|01/10/1994|||APPR|
P820083|S017|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) SUTURE|GAW|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/1994|08/19/1994|||APPR|
P820083|S018|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) SUTURE|GAW|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/18/1994|08/11/1994|||APPR|
P820083|S019|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) SUTURE|GAW|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/1994|01/23/1995|||APPR|
P820086|S001|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|||N|03/09/1984|05/02/1985|||APPR|
P820086|S003|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|||N|01/17/1985|06/25/1985|||APPR|
P820086|S004|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|||N|02/07/1985|07/30/1985|||APPR|
P820086|S005|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|||N|05/10/1985|03/31/1986|||APPR|
P820086|S006|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|||N|02/20/1986|03/31/1987|87M-0124|05/04/1987|APPR|
P820086|S008|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1988|01/12/1989|||APPR|
P820086|S010|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/16/1990|||APPR|
P820086|S011|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/1989|11/23/1993|||APPR|
P820086|S012|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Lenses, soft contact, daily wear|CIBATINT(TM) TINTING PROCESS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/1989|01/31/1990|||APPR|
P820087|S001|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|||N|11/08/1983|02/08/1985|||APPR|
P820087|S002|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|||N|11/08/1983|02/08/1985|||APPR|
P820087|S003|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|||N|04/16/1985|11/04/1985|||APPR|
P820087|S004|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|||N|04/16/1985|11/18/1985|||APPR|
P820087|S005|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|||N|03/04/1986|07/07/1986|||APPR|
P820087|S006|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|||N|03/04/1986|07/07/1986|||APPR|
P820087|S007|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/1987|09/09/1987|||APPR|
P820087|S008|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|Normal 180 Day Track|Other Report|N|05/04/1987|11/27/1987|||APPR|
P820087|S009|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/1987|01/19/1988|||APPR|
P820087|S010|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1987|10/30/1987|||APPR|
P820087|S011|ATRION MEDICAL PRODUCTS, INC.|1426 CURT FRANCIS RD.||ARAB|AL|35016||Accessories, soft lens products|KESTREL NO. 695 HEATER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1987|06/17/1988|||APPR|
P820088|S001|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|||N|09/29/1983|01/27/1984|||APPR|
P820088|S002|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|Normal 180 Day Track||N|11/28/1983|07/24/1984||08/27/1984|APPR|
P820088|S003|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|||N|09/04/1984|10/29/1984|||APPR|
P820088|S004|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|||N|04/23/1985|10/01/1985|||APPR|
P820088|S005|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/1986|09/23/1986|||APPR|
P820088|S006|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/03/1987|12/13/1988|||APPR|
P820088|S008|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/14/1989|03/28/1991|||APPR|
P820088|S011|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1989|06/21/1990|||APPR|
P820088|S014|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD 1000 HYPERTHERMIA SYSTEM|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1991|11/26/1991|||APPR|
P830001|S001|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Sterilizer, soft-lens, thermal, ac-powered|HEATCASE(TM)|HRD|OP|||N|11/14/1983|11/30/1984|||APPR|
P830001|S002|WESLEY JESSEN CORP.|400 WEST SUPERIOR ST.||CHICAGO|IL|60610||Sterilizer, soft-lens, thermal, ac-powered|HEATCASE(TM)|HRD|OP|||N|12/09/1983|01/18/1984|||APPR|
P830003|S002|OPTICAL PLASTIC RESEARCH|1150 BURNETT AVE. STE. A||CONCORD|CA|94529||Lenses, soft contact, daily wear|SOFTVIEW SPHERICAL & TORIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1987|09/28/1987|||APPR|
P830003|S004|OPTICAL PLASTIC RESEARCH|1150 BURNETT AVE. STE. A||CONCORD|CA|94529||Lenses, soft contact, daily wear|SOFTVIEW SPHERICAL & TORIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1987|12/01/1987|||APPR|
P830003|S005|OPTICAL PLASTIC RESEARCH|1150 BURNETT AVE. STE. A||CONCORD|CA|94529||Lenses, soft contact, daily wear|SOFTVIEW SPHERICAL & TORIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1987|09/28/1987|||APPR|
P830006|S001|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT II (POLYMACON)|LPL|OP|||N|12/13/1983|05/09/1985|||APPR|
P830006|S002|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT II (POLYMACON)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/1986|07/31/1986|||APPR|
P830006|S003|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT II (POLYMACON)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1986|08/07/1986|||APPR|
P830006|S004|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT II (POLYMACON)|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/1989|01/22/1990|||APPR|
P830006|S005|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT II (POLYMACON)|LPL|OP|Normal 180 Day Track|Other Report|N|04/18/1990|05/08/1990|||APPR|
P830006|S006|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT II (POLYMACON)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/1992|04/15/1992|||APPR|
P830006|S007|PREMIER CONTACT LENS|201 FOURTH AVENUE NORTH||NASHVILLE|TN|37219|2040|Lenses, soft contact, daily wear|SOFTACT II (POLYMACON)|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/1994|03/01/1994|||APPR|
P830007|S001|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|09/23/1983|12/06/1983|||APPR|
P830007|S002|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|12/08/1983|03/07/1984|||APPR|
P830007|S003|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|01/17/1984|02/07/1984|||APPR|
P830007|S004|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track||N|10/15/1984|06/10/1985|||APPR|
P830007|S005|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track||N|01/08/1985|04/09/1985|||APPR|
P830007|S006|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track||N|01/08/1985|05/05/1986|||APPR|
P830007|S007|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track||N|02/25/1985|04/17/1985|||APPR|
P830007|S009|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|05/30/1985|06/25/1985|||APPR|
P830007|S010|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|06/03/1985|06/25/1985|||APPR|
P830007|S012|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|07/12/1985|08/12/1985|||APPR|
P830007|S013|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|08/09/1985|10/21/1985|||APPR|
P830007|S014|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|10/15/1985|03/11/1986|||APPR|
P830007|S015|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|11/20/1985|02/12/1986|||APPR|
P830007|S016|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|||N|12/05/1985|03/14/1986|||APPR|
P830007|S017|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/1986|10/20/1986|||APPR|
P830007|S018|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Special (Immediate Track)|Other Report|N|10/16/1986|12/01/1986|||APPR|
P830007|S019|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/1986|01/30/1987|||APPR|
P830007|S020|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1987|03/27/1987|||APPR|
P830007|S021|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/1987|04/08/1987|||APPR|
P830007|S022|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1987|01/11/1988|||APPR|
P830007|S023|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/1988|04/06/1988|||APPR|
P830007|S024|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1988|04/12/1988|||APPR|
P830007|S025|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1988|03/17/1988|||APPR|
P830007|S026|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/1988|08/04/1988|||APPR|
P830007|S027|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/14/1988|08/04/1988|||APPR|
P830007|S028|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/1988|07/21/1988|||APPR|
P830007|S029|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/1989|04/18/1989|||APPR|
P830007|S030|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1989|03/22/1990|||APPR|
P830007|S031|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Other Report|N|01/16/1990|02/02/1990|||APPR|
P830007|S032|TELECTRONICS PACING SYSTEMS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||Implantable pulse generator, pacemaker (non-CRT)|GEMINI(R) THETA MODEL 415A CARDIAC PACER|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1990|05/09/1990|||APPR|
P830008|S001|SENSORMEDICS CORP.|1630 S. STATE COLLEGE BLVD.||ANAHEIM|CA|92806||MONITOR, CARBON-DIOXIDE, CUTANEOUS|CUTANIOUS GAS MONITOR|LKD|CV|||N|02/16/1984|10/29/1984|||APPR|
P830008|S002|SENSORMEDICS CORP.|1630 S. STATE COLLEGE BLVD.||ANAHEIM|CA|92806||MONITOR, CARBON-DIOXIDE, CUTANEOUS|CUTANIOUS GAS MONITOR|LKD|CV|||N|10/23/1984|01/11/1985|||APPR|
P830008|S003|SENSORMEDICS CORP.|1630 S. STATE COLLEGE BLVD.||ANAHEIM|CA|92806||MONITOR, CARBON-DIOXIDE, CUTANEOUS|CUTANIOUS GAS MONITOR|LKD|CV|||N|11/06/1984|02/29/1988|||APPR|
P830009|S001|EATON MEDICAL CORP.|2288 DUNN AVE.||MEMPHIS|TN|38114||Accessories, soft lens products|EASY EYES (TM)|LPN|OP|||N|09/30/1983|02/08/1984|||APPR|
P830009|S002|EATON MEDICAL CORP.|2288 DUNN AVE.||MEMPHIS|TN|38114||Accessories, soft lens products|EASY EYES (TM)|LPN|OP|||N|10/07/1983|11/17/1983|||APPR|
P830009|S003|EATON MEDICAL CORP.|2288 DUNN AVE.||MEMPHIS|TN|38114||Accessories, soft lens products|EASY EYES (TM)|LPN|OP|||N|11/22/1983|05/15/1984|||APPR|
P830009|S004|EATON MEDICAL CORP.|2288 DUNN AVE.||MEMPHIS|TN|38114||Accessories, soft lens products|EASY EYES (TM)|LPN|OP|||N|02/14/1984|08/10/1984|||APPR|
P830009|S005|EATON MEDICAL CORP.|2288 DUNN AVE.||MEMPHIS|TN|38114||Accessories, soft lens products|EASY EYES (TM)|LPN|OP|||N|02/14/1984|03/15/1984|||APPR|
P830009|S006|EATON MEDICAL CORP.|2288 DUNN AVE.||MEMPHIS|TN|38114||Accessories, soft lens products|EASY EYES (TM)|LPN|OP|||N|05/07/1984|04/23/1985|||APPR|
P830009|S007|EATON MEDICAL CORP.|2288 DUNN AVE.||MEMPHIS|TN|38114||Accessories, soft lens products|EASY EYES (TM)|LPN|OP|||N|05/22/1984|04/23/1985|||APPR|
P830009|S008|EATON MEDICAL CORP.|2288 DUNN AVE.||MEMPHIS|TN|38114||Accessories, soft lens products|EASY EYES (TM)|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/1987|03/23/1988|||APPR|
P830010|S001|ORGANON TEKNIKA CORP.|5300 SOUTH PORTLAND AVE.||OKLAHOMA CITY|OK|73119||Separator for therapeutic purposes, membrane automated blood cell/plasma|CURESIS PLASMA SEPARATOR|MDP|GU|||N|11/19/1984|02/12/1985|||APPR|
P830010|S003|ORGANON TEKNIKA CORP.|5300 SOUTH PORTLAND AVE.||OKLAHOMA CITY|OK|73119||Separator for therapeutic purposes, membrane automated blood cell/plasma|CURESIS PLASMA SEPARATOR|MDP|GU|||N|07/30/1985|12/06/1985|||APPR|
P830012|S001|IDEAL OPTICS, INC.|4000 CUMBERLAND PARKWAY,|BLDG.500|ATLANTA|GA|30339||Lenses, soft contact, daily wear|SOFTICS(TM) (POLYMACON)|LPL|OP|Normal 180 Day Track|Other Report|N|05/22/1987|09/09/1987|||APPR|
P830012|S003|IDEAL OPTICS, INC.|4000 CUMBERLAND PARKWAY,|BLDG.500|ATLANTA|GA|30339||Lenses, soft contact, daily wear|SOFTICS(TM) (POLYMACON)|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1988|08/29/1988|||APPR|
P830012|S004|IDEAL OPTICS, INC.|4000 CUMBERLAND PARKWAY,|BLDG.500|ATLANTA|GA|30339||Lenses, soft contact, daily wear|SOFTICS(TM) (POLYMACON)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/1989|06/25/1990|||APPR|
P830013|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L SENSITIVE EYES(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1987|06/11/1987|||APPR|
P830013|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L SENSITIVE EYES(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1987|08/15/1990|||APPR|
P830013|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L SENSITIVE EYES(TM) DAILY CLEANER|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/1988|03/14/1988|||APPR|
P830013|S004|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L SENSITIVE EYES(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/1988|09/26/1988|||APPR|
P830013|S005|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L SENSITIVE EYES(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1993|04/13/1994|||APPR|
P830014|S001|Abbott Laboratories|ABBOTT PARK||NORTH CHICAGO|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|CORAB-M|LOM|MI|||N|02/13/1984|05/03/1984|||APPR|
P830017|S001|ORGANON TEKNIKA CORP.|||WEST ORANGE|NJ|07052||Hepatitis a test (antibody and igm antibody)|9EPANOSTIKA(TM) ANTI-HAV IGM|LOL|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/1989|03/21/1990|||APPR|
P830018|S001|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||Hepatitis a test (antibody and igm antibody)|HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM|LOL|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/1989|03/21/1990|||APPR|
P830023|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|COOPERVISION PEROXIDE SYSTEM|LPN|OP|||N|04/25/1986|06/03/1986|||APPR|
P830023|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|COOPERVISION PEROXIDE SYSTEM|LPN|OP|THIRTY DAY TRACK|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/1986|03/06/1987|||APPR|
P830023|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|COOPERVISION PEROXIDE SYSTEM|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/1987|09/15/1987|||APPR|
P830023|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|COOPERVISION PEROXIDE SYSTEM|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/1987|07/31/1987|||APPR|
P830023|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|COOPERVISION PEROXIDE SYSTEM|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/1988|03/27/1989|||APPR|
P830023|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|COOPERVISION PEROXIDE SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/1989|08/30/1989|||APPR|
P830023|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|COOPERVISION PEROXIDE SYSTEM|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P830025|S001|MEDICAL LASER, INC.|5454 WISCONSIN AVE.||CHEVY CHASE|MD|20815||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MEDITEC OPL3 ND:YAG LASER|LOI|OP|||N|02/22/1985|06/25/1985|||APPR|
P830025|S002|MEDICAL LASER, INC.|5454 WISCONSIN AVE.||CHEVY CHASE|MD|20815||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MLI 1000 ND:YAG OP LASER|LOI|OP|||N|07/29/1985|09/06/1985|||APPR|
P830026|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|07/02/1984|02/07/1985|||APPR|
P830026|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|08/16/1984|02/12/1986|||APPR|
P830026|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|10/03/1984|11/16/1984|||APPR|
P830026|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|11/29/1984|02/27/1985|||APPR|
P830026|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|01/22/1985|02/27/1985|||APPR|
P830026|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|02/15/1985|07/10/1985|||APPR|
P830026|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NOVA(TM) PULSE GENERATOR 7 RX 2000(TM) PROGRAMMER|LWP|CV|||N|02/21/1985|07/11/1985|||APPR|
P830026|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|03/06/1985|07/11/1985|||APPR|
P830026|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|06/17/1985|08/05/1985|||APPR|
P830026|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|07/22/1985|08/14/1985|||APPR|
P830026|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|09/27/1985|11/05/1985|||APPR|
P830026|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|12/17/1985|02/12/1986|||APPR|
P830026|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|12/23/1985|03/06/1986|||APPR|
P830026|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|02/18/1986|08/28/1986|||APPR|
P830026|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|||N|05/06/1986|09/10/1986|||APPR|
P830026|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/1986|08/28/1986|||APPR|
P830026|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1986|08/28/1986|||APPR|
P830026|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Special (Immediate Track)|Other Report|N|09/26/1986|02/03/1987|||APPR|
P830026|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1986|02/10/1987|||APPR|
P830026|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1986|02/03/1987|||APPR|
P830026|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/1987|03/24/1987|||APPR|
P830026|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/1987|03/24/1987|||APPR|
P830026|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/1987|06/26/1987|||APPR|
P830026|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/1987|06/26/1987|||APPR|
P830026|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/11/1987|06/26/1987|||APPR|
P830026|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/13/1987|08/10/1987|||APPR|
P830026|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Special (Immediate Track)|Other Report|N|05/12/1987|06/26/1987|||APPR|
P830026|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/1987|10/21/1987|||APPR|
P830026|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/1987|08/21/1987|||APPR|
P830026|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1987|09/18/1987|||APPR|
P830026|S033|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/22/1987|10/16/1987|||APPR|
P830026|S034|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/1988|10/24/1988|||APPR|
P830026|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1988|10/24/1988|||APPR|
P830026|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1988|10/24/1988|||APPR|
P830026|S037|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1988|11/23/1988|||APPR|
P830026|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/1989|05/05/1989|||APPR|
P830026|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(TM) SYSTEM|LWP|CV|Normal 180 Day Track|Other Report|N|09/15/1989|02/16/1990|||APPR|
P830026|S040|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX2000(TM) GRAPHICS PROGRAM MODULE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1990|05/30/1990|||APPR|
P830026|S041|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX2000(TM) GRAPHICS PROGRAMMER-MODEL 522-06|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/1990|05/30/1990|||APPR|
P830026|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS, NOVA, NOVA II, & QUANTUM II|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1990|05/30/1990|||APPR|
P830026|S043|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS II(R) PULSE GENERATORS MODEL 283-03, 284-05|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1990|05/30/1990|||APPR|
P830026|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NOVA II-281-05,282--04,QUANTUM II,253-25,254-30|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1990|07/18/1990|||APPR|
P830026|S045|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NOVA II MODEL 282-04R PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1991|05/16/1991|||APPR|
P830026|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NOVA II MODEL 282-04Y PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1991|05/16/1991|||APPR|
P830026|S047|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NOVA II MODEL 282-04Y PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/1991|11/26/1991|||APPR|
P830026|S048|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NOVA II MODEL 282-04Y PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/1991|07/31/1991|||APPR|
P830026|S049|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS II IMPLANTABLE PACEMAKER PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1991|11/20/1991|||APPR|
P830026|S051|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 282-04R NOVA(TM)II|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1991|01/17/1992|||APPR|
P830026|S052|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 282-04Y NOVA(TM)II|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1991|01/21/1992|||APPR|
P830026|S053|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 370-08 WAND EXTENSION FOR COSMOS(R)RX2000|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/1992|03/20/1992|||APPR|
P830026|S054|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R)|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1992|12/29/1992|||APPR|
P830026|S055|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1992|01/11/1993|||APPR|
P830026|S056|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1992|05/06/1994|||APPR|
P830026|S057|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX222 MODEL 522-10 POCKET PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1992|03/03/1993|||APPR|
P830026|S058|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS II MODELS 284-05,283-03 PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1993|08/04/1993|||APPR|
P830026|S059|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS II MODELS 284-05,283-03 PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1993|05/17/1994|||APPR|
P830026|S060|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS II MODELS 284-05,283-03 PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/1993|05/17/1994|||APPR|
P830026|S061|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 522-12 RX5000(TM) PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1994|03/09/1995|||APPR|
P830028|S001|ANALYTICAL PRODUCTS, INC.|200 EXPRESS STREET||PLAINVIEW|NY|11803||Manual antimicrobial susceptibility test systems|UNISCEPT(TM)|JWY|MI|||N|01/25/1984|03/09/1984|||APPR|
P830033|S001|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|||N|07/25/1983|11/25/1985|||APPR|
P830033|S002|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|||N|10/16/1985|11/25/1985|||APPR|
P830033|S003|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|||N|04/14/1986|04/25/1986|||APPR|
P830033|S004|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|||N|04/14/1986|04/25/1986|||APPR|
P830033|S005|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|||N|03/28/1986|09/26/1986|||APPR|
P830033|S006|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1986|06/27/1986|||APPR|
P830033|S007|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/1986|12/12/1986|||APPR|
P830033|S008|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/1986|01/12/1987|||APPR|
P830033|S009|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/10/1986|08/01/1989|||APPR|
P830033|S010|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1986|08/01/1989|||APPR|
P830033|S012|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1988|10/13/1988|||APPR|
P830033|S013|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/1988|09/01/1989|||APPR|
P830033|S014|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|09/29/1988|10/17/1989|89M-0458|11/14/1989|APPR|
P830033|S015|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|11/09/1988|08/18/1989|||APPR|
P830033|S016|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|STYLE 17 & 17A POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/1988|11/30/1989|||APPR|
P830033|S018|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|SINGLE-PIECE UV-ABSORBING POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/27/1989|07/20/1990|||APPR|
P830033|S021|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|SINGLE-PIECE UV-ABSORBING POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1990|10/05/1990|||APPR|
P830033|S022|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|MODEL 5BUV20-24DO IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/1990|11/15/1990|||APPR|
P830033|S023|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|MODELS PCUB-32D0 AND PCUB-53D0|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/1990|05/28/1991|||APPR|
P830033|S024|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|MODEL 56BUV20-24DO IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1991|10/07/1991|||APPR|
P830033|S025|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|TIER B MODEL SBUV20-23DO IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1991|03/20/1992|||APPR|
P830033|S026|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|MODELS PCUB-30SEO AND PCUB-32SEO IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/1994|06/05/1995|||APPR|
P830033|S027|ADVANCED VISION SCIENCE|5743 THORNWOOD DR.||GOLETA|CA|93117||intraocular lens|SINGLE-PIECE AND THREE PIECE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/1994|01/29/1996|||APPR|APPROVAL TO CHANGE VENDORS OF THE POLYMETHYLMETHACRYLATE (PMMA) MATERIAL USED TO MANUFACTURE IOLS APROVED UNDER THIS PMA AND ITS SUPPLEMENTS
P830034|S001|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|||N|04/11/1985|10/22/1985|||APPR|
P830034|S002|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|||N|10/22/1985|05/22/1987|||APPR|
P830034|S003|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/1987|07/21/1988|||APPR|
P830034|S004|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/17/1987|06/27/1988|||APPR|
P830034|S005|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/1988|05/02/1989|||APPR|
P830034|S006|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/1989|06/05/1989|||APPR|
P830034|S008|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/1989|06/01/1989|||APPR|
P830034|S009|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/22/1989|02/28/1990|||APPR|
P830034|S010|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|POLYQUAT DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/1989|04/16/1990|||APPR|
P830034|S011|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING, DISINFECTING & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/1989|03/29/1990|||APPR|
P830034|S012|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING, DISINFECTING & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/1990|05/08/1990|||APPR|
P830034|S013|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING, DISINFECTING & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/1990|05/22/1991|||APPR|
P830034|S015|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING, DISINFECTING & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/02/1990|07/17/1990|||APPR|
P830034|S016|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE REWETTING DROPS & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/02/1990|11/21/1990|||APPR|
P830034|S017|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-CLEAN II DAILY CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/21/1990|10/05/1990|||APPR|
P830034|S018|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING,& STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/29/1990|10/25/1990|||APPR|
P830034|S019|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING,& STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Other Report|N|10/10/1990|03/14/1994|||APPR|
P830034|S020|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING,& STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/1990|08/06/1991|||APPR|
P830034|S022|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION|LPN|OP|||N|06/13/1990|08/06/1992|||APPR|
P830034|S023|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/23/1992|12/02/1993|||APPR|
P830034|S025|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P830035|S001|INDEVUS PHARMACEUTICALS, INC.|8 CLARKE DR.||CRANBURY|NJ|08512||SOLUTION, REMOVAL, CARRIES|GK-101E CARIES REMOVAL AGENT/SYSTEM|LMW|DE|||N|10/01/1984|04/18/1985|||APPR|
P830035|S002|INDEVUS PHARMACEUTICALS, INC.|8 CLARKE DR.||CRANBURY|NJ|08512||SOLUTION, REMOVAL, CARRIES|CARIDEX(TM) REMOVAL SYSTEM|LMW|DE|||N|05/13/1985|08/28/1985|||APPR|
P830035|S003|INDEVUS PHARMACEUTICALS, INC.|8 CLARKE DR.||CRANBURY|NJ|08512||SOLUTION, REMOVAL, CARRIES|CARIDEX(TM) REMOVAL SYSTEM|LMW|DE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/1986|11/25/1987|||APPR|
P830037|S001|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|||N|04/27/1984|06/08/1984|||APPR|
P830037|S003|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|||N|06/21/1984|07/05/1984|||APPR|
P830037|S004|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|||N|11/21/1984|11/18/1985|||APPR|
P830037|S005|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|THIRTY DAY TRACK|Other Report|N|06/18/1985|11/06/1986|||APPR|
P830037|S006|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|||N|07/23/1985|11/06/1986|||APPR|
P830037|S007|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|||N|10/04/1985|08/07/1986|||APPR|
P830037|S008|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|||N|11/04/1985|12/13/1985|||APPR|
P830037|S009|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/08/1986|11/12/1986|||APPR|
P830037|S010|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/1986|02/17/1987|||APPR|
P830037|S011|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/1986|02/17/1987|||APPR|
P830037|S012|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/1987|04/27/1987|||APPR|
P830037|S013|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1987|06/22/1987|||APPR|
P830037|S014|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Other Report|N|05/20/1987|06/22/1987|||APPR|
P830037|S015|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Other Report|N|06/08/1987|07/07/1987|||APPR|
P830037|S016|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/1987|11/30/1988|||APPR|
P830037|S018|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/1987|08/10/1987|||APPR|
P830037|S019|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/1987|11/30/1988|||APPR|
P830037|S020|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1987|12/17/1987|||APPR|
P830037|S021|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT(R) 3 FOR EXT WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/1987|10/27/1987|||APPR|
P830037|S022|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1988|05/02/1989|||APPR|
P830037|S023|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1989|08/28/1989|||APPR|
P830037|S024|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1989|06/01/1989|||APPR|
P830037|S025|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1989|10/13/1989|||APPR|
P830037|S026|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|12/28/1989|||APPR|
P830037|S027|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/1989|01/23/1990|||APPR|
P830037|S028|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1989|11/03/1989|||APPR|
P830037|S029|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/1989|03/06/1990|||APPR|
P830037|S030|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|08/29/1990|||APPR|
P830037|S031|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT R3 (PHEMFILCON A) LENSES/SHELF LIFE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/1989|03/05/1990|||APPR|
P830037|S032|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT R3 (PHEMFILCON A) LENSES/SHELF LIFE|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/1991|10/04/1991|||APPR|
P830037|S033|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT R3 (PHEMFILCON A) LENSES/SHELF LIFE|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/1991|01/31/1994|||APPR|
P830037|S034|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT R3 (PHEMFILCON A) LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/1993|01/31/1994|||APPR|
P830037|S035|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT  3 (PHEMFILCON A) LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/1993|03/03/1994|||APPR|
P830037|S036|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT  3 (PHEMFILCON A) LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/28/1994|04/28/1994|||APPR|
P830037|S037|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT  3 (PHEMFILCON A) LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/1994|05/27/1994|||APPR|
P830037|S038|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT  3 (PHEMFILCON A) LENSES|LPM|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/1994|06/13/1994|||APPR|
P830039|S002|MEDICALCV, INC.|9725 SOUTH ROBERT TRAIL||INVER GROVE HEIGHTS|MN|55077||HEART-VALVE, MECHANICAL|OMNISCEINCE PROSTHETIC CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/1988|08/18/1988|||APPR|
P830040|S001|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|STYLES 30 & 31 POSTERIOR CHAMBER IOLS|HQL|OP|||N|11/09/1984|11/01/1985|||APPR|
P830040|S002|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|STYLES 30 & 31 POSTERIOR CHAMBER IOLS|HQL|OP|||N|04/10/1985|12/31/1985|||APPR|
P830040|S008|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|STYLES 30 & 31 POSTERIOR CHAMBER IOLS|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|11/14/1988|09/18/1989|||APPR|
P830040|S009|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|STYLES 30 & 31 POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/1988|09/18/1989|||APPR|
P830040|S010|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|STYLES 30 & 31 POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1988|10/10/1989|||APPR|
P830040|S011|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|8TYLES 30 & 31 POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1988|10/10/1989|||APPR|
P830040|S013|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|STYLES 30 & 31 POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1989|06/28/1990|||APPR|
P830040|S014|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|POLYMETHYLMETHACRYLATE POSTERIOR CHAMBER INTR. LEN|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/1990|06/15/1990|||APPR|
P830040|S015|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|POLYMETHYLMETHACRYLATE POSTERIOR CHAMBER INTR. LEN|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/1990|12/05/1990|||APPR|
P830040|S017|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/1991|07/03/1991|||APPR|
P830040|S018|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES STYLE 38XE|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/1991|09/23/1991|||APPR|
P830040|S020|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES STYLE 58LE|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1991|03/09/1992|||APPR|
P830040|S021|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES STYLE 58LE|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/1991|03/09/1992|||APPR|
P830040|S022|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES STYLE 150X|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/1991|03/31/1992|||APPR|
P830040|S023|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV|HQL|OP|Normal 180 Day Track||N|10/01/1991|10/17/1991|||APPR|
P830045|S001|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|04/27/1984|10/09/1984|||APPR|
P830045|S002|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|08/09/1984|01/08/1985|||APPR|
P830045|S003|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|09/07/1984|11/19/1984|||APPR|
P830045|S004|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|09/21/1984|02/02/1985|||APPR|
P830045|S005|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|09/28/1984|11/16/1984|||APPR|
P830045|S006|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track||N|10/24/1984|01/09/1985|||APPR|
P830045|S007|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|01/04/1985|02/27/1985|||APPR|
P830045|S008|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|02/06/1985|06/19/1985|||APPR|
P830045|S009|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|||N|02/20/1985|09/26/1985|||APPR|
P830045|S011|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/1986|02/13/1987|||APPR|
P830045|S013|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/1987|08/10/1988|||APPR|
P830045|S014|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/1988|09/08/1988|||APPR|
P830045|S015|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1988|03/09/1989|||APPR|
P830045|S016|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1988|04/13/1989|||APPR|
P830045|S017|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/30/1988|04/13/1989|||APPR|
P830045|S018|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Other Report|N|01/13/1989|05/01/1989|||APPR|
P830045|S019|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/1989|08/17/1989|||APPR|
P830045|S020|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1989|09/19/1989|||APPR|
P830045|S021|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/1989|05/04/1990|||APPR|
P830045|S022|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 3033C FUCTION PACT USE W/MODEL 3000 PROGRAMM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1989|05/04/1990|||APPR|
P830045|S024|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/1989|03/30/1990|||APPR|
P830045|S025|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER|LWP|CV|Normal 180 Day Track|Other Report|N|11/13/1989|01/18/1990|||APPR|
P830045|S026|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/1990|07/26/1990|||APPR|
P830045|S027|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER|LWP|CV|Normal 180 Day Track|Other Report|N|07/24/1990|12/19/1990|||APPR|
P830045|S028|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1990|01/31/1991|||APPR|
P830045|S029|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PARAGON(TM) MODEL 2011M/S PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/29/1990|12/20/1990|||APPR|
P830045|S030|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 283 PULSE GENERATOR & MODEL 370 PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1990|08/07/1991|||APPR|
P830045|S031|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PACESETTER MODEL 3070 & PACE MEDICAL MODEL 4553|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/04/1991|09/11/1991|||APPR|
P830045|S032|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PACESETTER MODEL 3070 & PACE MEDICAL MODEL 4553|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/1991|01/11/1993|||APPR|APPROVAL FOR RELOCATING THE MANUFACTURING FACILITIES TO 15900 VALLEYVIEW COURT, SYLMAR, CA., 91392-9221
P830045|S033|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|APS-II MODEL 3003 PROGRAMMER|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/1991|09/16/1991|||APPR|
P830045|S034|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 3037A FUNCTION PACK|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/1991|12/24/1991|||APPR|
P830045|S035|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 3037A FUNCTION PACK|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1991|10/28/1991|||APPR|
P830045|S036|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 283 PULSE GENERATOR & MODEL 370 PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1991|02/25/1992|||APPR|
P830045|S037|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 3038 FUNCTION PACT FOR ASP-II 3003 PROGRAMME|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1991|04/14/1992|||APPR|
P830045|S038|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/17/1992|02/05/1993|||APPR|
P830045|S039|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1992|11/18/1992|||APPR|
P830045|S041|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1992|01/22/1993|||APPR|
P830045|S042|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/1993|06/04/1993|||APPR|
P830045|S043|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYS. MODEL 385 G FUNCTION PACK|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1993|07/12/1994|||APPR|
P830045|S044|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYS. MODEL 3039  FUNCTION PACK|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1993|07/12/1994|||APPR|
P830045|S045|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|SIEMENS PACESETTER MODEL 3070|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/1993|09/02/1993|||APPR|
P830045|S046|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1993|09/27/1994|||APPR|
P830045|S047|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1994|03/27/1995|||APPR|
P830045|S048|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/12/1994|12/13/1994|||APPR|
P830045|S049|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/1994|01/05/1995|||APPR|
P830047|S001|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|Lenses, soft contact, extended wear|X-70 SOFT CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/1986|11/14/1986|||APPR|
P830047|S002|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|Lenses, soft contact, extended wear|X-70 SOFT CONTACT LENS|LPM|OP|Normal 180 Day Track|Other Report|N|07/21/1987|08/12/1987|||APPR|
P830047|S003|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|Lenses, soft contact, extended wear|X-70 SOFT CONTACT LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/04/1987|01/20/1988|||APPR|
P830047|S004|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|Lenses, soft contact, extended wear|X-70 SOFT CONTACT LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|12/28/1989|||APPR|
P830047|S005|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|Lenses, soft contact, extended wear|M-70 (LIDOFILCON A) HYDROPHILIC CONTACT LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1990|11/14/1990|||APPR|
P830047|S006|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|Lenses, soft contact, extended wear|OMNIFLEX(TM) SOFBLUE(R) HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/1991|07/26/1991|||APPR|
P830050|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lens, contact (polymethylmethacrylate)|B&L(R) (AMEFOCON A)  OXYGEN PERMEABLE LENS|HPX|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1987|05/08/1987|||APPR|
P830051|S001|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|05/23/1984|10/22/1984|||APPR|
P830051|S002|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|03/06/1985|08/08/1985|||APPR|
P830051|S003|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|04/30/1985|12/18/1985|||APPR|
P830051|S004|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|05/07/1985|07/12/1985|||APPR|
P830051|S005|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|08/16/1985|04/16/1986|||APPR|
P830051|S006|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|10/08/1985|09/24/1986|||APPR|
P830051|S007|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|02/05/1986|10/01/1986|||APPR|
P830051|S008|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|03/06/1986|04/30/1986|||APPR|
P830051|S009|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|04/10/1986|10/01/1986|||APPR|
P830051|S010|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|||N|04/10/1986|10/01/1986|||APPR|
P830051|S011|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/29/1986|11/14/1986|||APPR|
P830051|S012|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1986|11/05/1986|||APPR|
P830051|S013|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1986|10/22/1986|||APPR|
P830051|S014|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/1987|08/26/1987|||APPR|
P830051|S015|TECHNICARE CORP.|PO BOX 5130||CLEVELAND|OH|44101||System, nuclear magnetic resonance imaging|TESLACON(TM) NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1988|07/14/1988|||APPR|
P830052|S002|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Other Report|N|03/06/1984|07/02/1986|||APPR|
P830052|S003|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track||N|10/12/1984|02/05/1986|||APPR|
P830052|S005|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track||N|08/28/1985|05/28/1986|||APPR|
P830052|S006|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track||N|02/14/1986|08/07/1986|||APPR|
P830052|S007|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Other Report|N|05/28/1986|09/22/1986|||APPR|
P830052|S008|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Other Report|N|08/21/1986|09/29/1987|||APPR|
P830052|S009|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1986|11/20/1987|||APPR|
P830052|S010|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/1987|11/05/1987|||APPR|
P830052|S011|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1987|03/01/1988|||APPR|
P830052|S012|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1987|04/14/1988|||APPR|
P830052|S013|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1987|04/26/1988|||APPR|
P830052|S014|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/1987|04/26/1988|||APPR|
P830052|S015|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/1987|05/16/1988|||APPR|
P830052|S016|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/1988|04/28/1988|||APPR|
P830052|S017|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/1988|05/16/1988|||APPR|
P830052|S018|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|04/01/1988|06/13/1988|||APPR|
P830052|S019|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1988|07/27/1988|||APPR|
P830052|S021|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|07/05/1988|07/14/1988|||APPR|
P830052|S022|PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.|595 MINER RD.||CLEVELAND|OH|44143||System, nuclear magnetic resonance imaging|NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000|LNH|RA|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|07/05/1988|07/14/1988|||APPR|
P830053|S001|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS MT/S (MAGNETIC TOMOGRAPHY/SUPERCONDUCTIN|LNH|RA|||N|06/19/1984|08/14/1984|||APPR|
P830053|S003|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|08/22/1984|01/11/1985|||APPR|
P830053|S004|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|10/05/1984|10/12/1984|||APPR|
P830053|S006|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|12/13/1984|01/11/1985|||APPR|
P830053|S007|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|12/24/1984|05/07/1985|||APPR|
P830053|S008|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|01/10/1985|03/19/1985|||APPR|
P830053|S009|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|02/22/1985|02/11/1986|||APPR|
P830053|S010|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|02/22/1985|02/11/1986|||APPR|
P830053|S011|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|04/01/1985|06/18/1985|||APPR|
P830053|S012|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|04/11/1985|04/22/1985|||APPR|
P830053|S013|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|05/23/1985|07/10/1985|||APPR|
P830053|S014|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|10/07/1985|12/30/1985|||APPR|
P830053|S015|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|10/09/1985|12/18/1985|||APPR|
P830053|S016|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|11/26/1985|12/24/1985|||APPR|
P830053|S018|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|03/12/1986|06/05/1986|||APPR|
P830053|S019|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|||N|05/13/1986|08/08/1986|||APPR|
P830053|S020|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/1986|03/17/1987|||APPR|
P830053|S021|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/17/1986|11/26/1986|||APPR|
P830053|S022|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/12/1986|03/30/1987|||APPR|
P830053|S023|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1986|01/07/1987|||APPR|
P830053|S024|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Other Report|N|11/19/1986|03/17/1987|||APPR|
P830053|S025|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1987|03/20/1987|||APPR|
P830053|S026|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|03/19/1987|07/13/1987|||APPR|
P830053|S027|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1987|06/22/1987|||APPR|
P830053|S028|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|02/02/1988|03/03/1988|||APPR|
P830053|S029|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/1988|07/07/1988|||APPR|
P830053|S030|DIASONICS, INC.|533 CABOT RD.||S. SAN FRANCISCO|CA|94080||System, nuclear magnetic resonance imaging|DIASONICS NMR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Other Report|N|06/06/1988|07/27/1988|||APPR|
P830054|S001|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|||N|11/20/1984|01/16/1985|||APPR|
P830054|S002|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|||N|11/27/1984|05/09/1985|||APPR|
P830054|S003|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track||N|12/10/1984|02/15/1985|||APPR|
P830054|S005|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|||N|01/03/1985|02/15/1985|||APPR|
P830054|S006|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|||N|06/21/1985|02/10/1986|||APPR|
P830054|S009|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/1986|11/07/1986|86M-0486|12/31/1986|APPR|
P830054|S010|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1986|08/11/1986|||APPR|
P830054|S011|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1986|09/25/1986|||APPR|
P830054|S012|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/1986|10/16/1986|||APPR|
P830054|S013|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/1986|10/15/1986|||APPR|
P830054|S015|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/1986|12/01/1986|||APPR|
P830054|S016|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/1986|10/31/1986|||APPR|
P830054|S017|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1987|03/31/1987|||APPR|
P830054|S018|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1987|05/19/1987|||APPR|
P830054|S019|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/1987|07/21/1987|||APPR|
P830054|S020|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1987|12/01/1987|||APPR|
P830054|S021|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/1988|08/30/1988|||APPR|
P830054|S022|COHERENT MEDICAL DIVISION|3270 WEST BAYSHORE RD.|P.O. BOX 10122|PALO ALTO|CA|94303||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/1989|08/29/1989|||APPR|
P830055|S001|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Normal 180 Day Track||N|12/18/1984|04/25/1985|||APPR|
P830055|S002|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Normal 180 Day Track||N|03/11/1985|04/12/1985||05/20/1985|APPR|
P830055|S003|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|||N|04/17/1985|11/08/1985|||APPR|
P830055|S005|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(TM) TOTAL KNEE SYSTEM|NJL|OR|||N|06/11/1985|08/29/1985|||APPR|
P830055|S006|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|||N|11/18/1985|01/08/1986|||APPR|
P830055|S007|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|||N|01/22/1986|02/21/1986|||APPR|
P830055|S008|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|||N|03/25/1986|04/25/1986|||APPR|
P830055|S009|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|||N|05/21/1986|07/10/1986|||APPR|
P830055|S010|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|06/10/1986|07/24/1986|||APPR|
P830055|S012|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/13/1988|07/25/1988|||APPR|
P830055|S013|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1988|08/14/1989|||APPR|
P830055|S014|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/16/1989|09/26/1990|90M-0335|11/28/1990|APPR|
P830055|S015|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/1989|07/05/1990|||APPR|
P830055|S016|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/1991|04/02/1991|||APPR|
P830055|S017|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/26/1991|02/24/1994|94M-0062|04/18/1994|APPR|
P830055|S018|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/1991|09/23/1991|||APPR|
P830055|S019|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/1991|12/04/1991|||APPR|
P830055|S021|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/1992|12/19/1994|||APPR|
P830055|S022|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1992|12/03/1992|||APPR|
P830055|S023|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Other Report|N|11/02/1992|07/22/1993|||APPR|
P830055|S024|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1992|01/08/1993|||APPR|
P830055|S025|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1992|06/04/1993|||APPR|
P830055|S027|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1992|06/04/1993|||APPR|
P830055|S028|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/1992|06/04/1993|||APPR|
P830055|S029|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/1993|06/04/1993|||APPR|
P830055|S030|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/1993|03/17/1994|||APPR|
P830055|S031|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/1993|03/17/1994|||APPR|
P830055|S032|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/10/1993|08/10/1994|||APPR|
P830055|S033|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1994|08/10/1994|||APPR|
P830055|S034|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1994|11/30/1994|||APPR|
P830055|S035|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/22/1994|01/18/1995|||APPR|
P830055|S036|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1994|08/23/1994|||APPR|
P830055|S038|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/1994|04/05/1995|||APPR|
P830056|S001|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLES 31-34 POSTERIOR IOLS|HQL|OP|||N|03/28/1986|03/31/1986|||APPR|
P830056|S002|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLES 31-34 POSTERIOR IOLS|HQL|OP|||N|02/24/1986|04/29/1986|||APPR|
P830056|S003|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLES 31-34 POSTERIOR IOLS|HQL|OP|||N|01/30/1986|07/25/1986|||APPR|
P830056|S004|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLES 31-34 POSTERIOR IOLS|HQL|OP|||N|04/25/1986|05/30/1986|||APPR|
P830056|S005|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLES 31-34 POSTERIOR IOLS|HQL|OP|||N|04/25/1986|05/30/1986|||APPR|
P830056|S006|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLES 31-34 POSTERIOR IOLS|HQL|OP|||N|04/25/1986|05/30/1986|||APPR|
P830056|S007|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLES 31-34 POSTERIOR IOLS|HQL|OP|||N|04/25/1986|05/30/1986|||APPR|
P830056|S008|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Other Report|N|06/09/1986|06/23/1986|||APPR|
P830056|S009|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/1986|07/24/1986|||APPR|
P830056|S011|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/1986|08/08/1986|||APPR|
P830056|S012|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/1986|08/28/1986|||APPR|
P830056|S013|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/1986|08/28/1986|||APPR|
P830056|S014|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Other Report|N|08/25/1986|09/29/1986|||APPR|
P830056|S015|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/1986|11/26/1986|||APPR|
P830056|S016|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/1986|12/29/1986|||APPR|
P830056|S017|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV31 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/1986|12/23/1986|||APPR|
P830056|S018|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV31 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1986|03/18/1987|||APPR|
P830056|S019|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV31 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1986|03/11/1987|||APPR|
P830056|S020|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV31 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1986|03/11/1987|||APPR|
P830056|S021|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1986|03/11/1987|||APPR|
P830056|S022|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/28/1986|01/09/1987|||APPR|
P830056|S023|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1986|03/18/1987|||APPR|
P830056|S024|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/16/1987|03/18/1987|||APPR|
P830056|S025|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Other Report|N|02/19/1987|04/10/1987|||APPR|
P830056|S026|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/1987|03/31/1987|||APPR|
P830056|S027|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Other Report|N|03/24/1987|05/19/1987|||APPR|
P830056|S028|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/1987|10/16/1987|||APPR|
P830056|S029|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/11/1987|01/13/1988|||APPR|
P830056|S030|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/1987|02/19/1988|||APPR|
P830056|S031|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Other Report|N|09/11/1987|02/23/1988|||APPR|
P830056|S032|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/1987|04/21/1988|||APPR|
P830056|S033|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1987|06/20/1989|||APPR|
P830056|S035|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/1988|05/03/1988|||APPR|
P830056|S036|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1988|08/22/1988|||APPR|
P830056|S039|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/1988|08/22/1988|||APPR|
P830056|S040|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/1988|08/15/1989|||APPR|
P830056|S041|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/1988|01/26/1989|||APPR|
P830056|S042|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/1988|08/18/1989|||APPR|
P830056|S043|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/1988|09/29/1989|||APPR|
P830056|S044|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1988|08/18/1989|||APPR|
P830056|S046|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1988|08/18/1989|||APPR|
P830056|S047|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1988|08/18/1989|||APPR|
P830056|S050|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|STYLE UV40 POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1988|06/26/1989|||APPR|
P830056|S055|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|MODEL U58OH POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/1988|12/29/1989|||APPR|
P830056|S060|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|MODEL U58OH POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/1989|06/26/1989|||APPR|
P830056|S061|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|MODEL U58OH POSTERIOR CHAMBER LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/1989|08/10/1989|||APPR|
P830056|S068|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|MODELS UV33A2 & UV33B2 J-LOOP INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/1989|03/28/1990|||APPR|
P830056|S069|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|ULTRAVIOLET ABSORBING POSTERIOR CHAMBER IOL LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/1990|10/25/1990|||APPR|
P830056|S070|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENS MODEL C410H|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/1990|06/12/1991|||APPR|
P830056|S071|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/1990|12/05/1990|||APPR|
P830056|S072|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENS MODEL C420F|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1990|11/27/1991|||APPR|
P830056|S074|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|MODELS UV42D2 AND U642B1 INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1993|05/17/1994|||APPR|
P830056|S075|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|POSTERIOR CHAMBER INTROCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/17/1994|04/02/1996|||APPR|APPROVAL FOR MODELS C420P, C540U, C445F, C840U, U240F0, C540MC, U211F, AND U241FO POSTERIOR CHAMBER INTRAOCULAR LENSES AS TIER A MODIFICATIONS OF CLINICALLY STUDIED PARTENT LENSES
P830060|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|||N|12/03/1985|03/27/1986|||APPR|
P830060|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|||N|02/03/1986|06/03/1986|||APPR|
P830060|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|Special (Immediate Track)|Other Report|N|08/06/1986|09/25/1986|||APPR|
P830060|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/1986|10/03/1986|||APPR|
P830060|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/22/1987|11/18/1987|||APPR|
P830060|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1988|07/25/1988|||APPR|
P830060|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/15/1988|11/08/1988|||APPR|
P830060|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/13/1989|08/15/1989|||APPR|
P830060|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/1989|01/05/1990|||APPR|
P830060|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1989|01/25/1990|||APPR|
P830060|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6577 STERILIZABLE TELEMETRY WAND|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1989|01/11/1990|||APPR|
P830060|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK 1550 PULSE GENERATOR|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/1989|01/04/1990|||APPR|
P830060|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK 1550 PULSE GENERATOR|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/1990|05/17/1991|||APPR|
P830060|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK 1550 PULSE GENERATOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/15/1990|05/04/1990|||APPR|
P830060|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK 1550 PULSE GENERATOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/1990|03/30/1990|||APPR|
P830060|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6836 Y CONNECTOR (AID B/BR)|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/1990|04/20/1990|||APPR|
P830060|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) MODEL 1555 PULSE GENERATOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/04/1990|09/13/1990|||APPR|
P830060|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) MODEL 1555 PULSE GENERATOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1990|09/17/1990|||APPR|
P830060|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CPI SUTURELESS MYOCARDIAL LEAD MODEL 4320|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/15/1990|01/07/1991|||APPR|
P830060|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID(R) B/BR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1990|02/08/1991|||APPR|
P830060|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CPI MODEL 6826 & 6828 AICD LEAD STYLET|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/27/1990|10/31/1990|||APPR|
P830060|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6837 & 6839 INDUCTION/MONITOR & 6871 O-RINGS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1990|05/16/1991|||APPR|
P830060|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(TM) ECD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1991|08/12/1991|||APPR|
P830060|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6577 STERILIZABLE TELEMETRY WAND|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/1991|11/20/1991|||APPR|
P830060|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6866 AICD SPLICE TOOL KIT,6862,63,65,34|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1991|12/18/1991|||APPR|
P830060|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ALTERNATE STERILIZATION/VENTAK(TM)1550,55 PULSE|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/1991|10/30/1992|||APPR|
P830060|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1991|12/26/1991|||APPR|
P830060|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MODELS 1550 AND 1555|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/1992|05/14/1992|||APPR|
P830060|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MODELS 1550 AND 1555|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1992|09/24/1992|||APPR|
P830060|S033|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MODEL  6910 LEAD ADAPTOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/1993|12/14/1993|||APPR|
P830060|S034|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MODELS 1550 AND 1555|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/1993|08/08/1994|||APPR|
P830060|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/1994|11/23/1994|||APPR|
P830061|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING|DTB|CV|Normal 180 Day Track|Other Report|N|09/11/1986|09/25/1986|||APPR|
P830061|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Other Report|N|09/25/1986|10/31/1986|||APPR|
P830061|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/1987|06/30/1987|||APPR|
P830061|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/1987|04/30/1987|||APPR|
P830061|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/20/1988|02/29/1988|||APPR|
P830061|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/1988|02/10/1989|||APPR|
P830061|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/1988|02/06/1989|||APPR|
P830061|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/23/1989|06/23/1989|||APPR|
P830061|S009|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/1989|04/26/1989|||APPR|
P830061|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1989|08/07/1991|||APPR|
P830061|S011|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MODELS 4004/4504 PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1989|03/28/1990|||APPR|
P830061|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R)SP MODELS 4024/4524 PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/1990|08/19/1991|||APPR|
P830061|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R)SP PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1990|09/27/1990|||APPR|
P830061|S014|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R)SP PACING LEADS|DTB|CV|Normal 180 Day Track|Other Report|N|07/24/1990|12/10/1990|||APPR|
P830061|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R)SP PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/07/1990|03/20/1991|||APPR|
P830061|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R) SP PACING LEADS|DTB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/1992|02/14/1992|||APPR|
P830061|S019|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R) SP PACING LEADS|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/15/1992|12/21/1993|||APPR|
P830061|S021|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R) SP PACING LEADS|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/1992|03/17/1994|||APPR|
P830061|S022|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) MODEL 4003M,4503M,4504M,& 4523 PACING|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1993|03/17/1994|||APPR|
P830061|S023|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/14/1994|01/31/1995|||APPR|
P830061|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/1994|12/12/1994|||APPR|
P830062|S001|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|||N|07/12/1984|10/23/1984|||APPR|
P830062|S002|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|||N|10/15/1984|02/14/1985|||APPR|
P830062|S006|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|||N|03/04/1985|05/02/1985|||APPR|
P830062|S007|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|||N|09/16/1985|11/26/1985|||APPR|
P830062|S009|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|||N|03/19/1986|04/08/1987|87M-0139|05/18/1987|APPR|
P830062|S010|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/02/1986|12/01/1986|||APPR|
P830062|S011|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/1987|06/11/1987|||APPR|
P830062|S012|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/15/1988|07/28/1988|||APPR|
P830062|S014|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/1989|08/30/1989|||APPR|
P830062|S015|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1989|09/08/1989|||APPR|
P830062|S016|NIDEK, INC.|47651 WESTINGHOUSE DR.||FREMONT|CA|94539||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|ND:YAG POSTERIOR CAPSULOTOMY MODEL 100|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/12/1990|03/13/1990|||APPR|
P830064|S001|COBURN OPTICAL IND., INC.|PROFFESSIONAL PRODUCTS DIV.|PO BOX 2498|CLEARWATER|FL|33517||Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla|NEODYMIUM-YAG OP LASER OPL-3|LXS|OP|||N|10/11/1984|02/06/1985|||APPR|
P830064|S002|COBURN OPTICAL IND., INC.|PROFFESSIONAL PRODUCTS DIV.|PO BOX 2498|CLEARWATER|FL|33517||Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla|NEODYMIUM-YAG OP LASER OPL-3|LXS|OP|||N|11/07/1984|12/13/1984|||APPR|
P830064|S003|COBURN OPTICAL IND., INC.|PROFFESSIONAL PRODUCTS DIV.|PO BOX 2498|CLEARWATER|FL|33517||Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla|NEODYMIUM-YAG OP LASER OPL-3|LXS|OP|||N|08/08/1985|05/28/1986|||APPR|
P830066|S001|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-RIA MONOCLONAL|DHX|IM|||N|12/16/1983|08/21/1984|||APPR|
P830066|S002|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT CEA-EIA KIT|DHX|IM|||N|03/05/1986|07/07/1986|||APPR|
P830066|S003|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT CEA-EIA KIT|DHX|IM|||N|03/26/1986|07/07/1986|||APPR|
P830066|S004|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT CEA-EIA ONE-STEP|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1987|11/02/1987|||APPR|
P830066|S006|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT CEA-EIA|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1988|03/28/1988|||APPR|
P830066|S007|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT CEA-EIA|DHX|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/1989|12/13/1989|||APPR|
P830066|S008|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT CEA-EIA|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1989|01/10/1990|||APPR|
P830066|S009|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT IMX-CEA (LIST 3A33)|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/1991|07/17/1992|||APPR|
P830066|S011|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT AXSYM CEA (LIST 7A47)|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1994|03/27/1995|||APPR|
P830069|S001|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN|MCM|EN|||N|02/11/1985|06/17/1985|||APPR|
P830069|S002|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN|MCM|EN|||N|04/10/1986|05/22/1986|||APPR|
P830070|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track||N|01/11/1985|05/03/1985|||APPR|
P830070|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|||N|01/28/1985|11/18/1985|||APPR|
P830070|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|||N|11/04/1985|12/13/1985|||APPR|
P830070|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/1986|04/13/1988|88M-0185|06/27/1988|APPR|
P830070|S005|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|07/01/1987|10/27/1987|||APPR|
P830070|S006|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/1987|03/01/1988|||APPR|
P830070|S007|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/1988|05/05/1988|||APPR|
P830070|S008|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1988|03/14/1988|||APPR|
P830070|S009|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Other Report|N|02/03/1988|03/14/1988|||APPR|
P830070|S010|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1988|03/17/1988|||APPR|
P830070|S011|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/1988|05/05/1988|||APPR|
P830070|S012|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1988|05/05/1988|||APPR|
P830070|S013|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/1988|05/05/1988|||APPR|
P830070|S014|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/1988|08/09/1988|||APPR|
P830070|S015|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/1988|08/09/1988|||APPR|
P830070|S016|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1988|08/08/1988|||APPR|
P830070|S017|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/1988|09/09/1988|||APPR|
P830070|S018|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/1988|08/09/1988|||APPR|
P830070|S019|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|07/15/1988|08/09/1988|||APPR|
P830070|S020|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/1988|08/09/1988|||APPR|
P830070|S021|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/1988|09/22/1988|||APPR|
P830070|S022|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/1988|08/22/1988|||APPR|
P830070|S023|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|08/15/1988|09/22/1988|||APPR|
P830070|S024|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/1988|09/20/1988|||APPR|
P830070|S025|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|09/06/1988|09/22/1988|||APPR|
P830070|S026|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Other Report|N|09/08/1988|09/22/1988|||APPR|
P830070|S027|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/1988|09/26/1988|||APPR|
P830070|S028|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1988|11/10/1988|||APPR|
P830070|S029|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1988|11/29/1988|||APPR|
P830070|S030|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|11/15/1988|12/21/1988|||APPR|
P830070|S031|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/1988|02/06/1989|||APPR|
P830070|S032|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1989|08/28/1989|||APPR|
P830070|S033|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|08/29/1990|||APPR|
P830071|S001|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|IMPROVED SOACLENS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/02/1988|08/05/1988|||APPR|
P830071|S002|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|IMPROVED SOACLENS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/1987|12/30/1987|||APPR|
P830071|S003|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|PD1413 WETTING, SOAKING AND DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/15/1990|02/16/1994|||APPR|
P830071|S004|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|PD1413 WETTING, SOAKING AND DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/1991|02/16/1994|||APPR|
P830071|S005|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|PD1413 WETTING, SOAKING AND DISINFECTING SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P830074|S001|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|||N|04/29/1985|09/10/1985|||APPR|
P830074|S002|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|||N|05/21/1985|10/18/1985|||APPR|
P830074|S003|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|||N|05/30/1985|10/30/1985|||APPR|
P830074|S004|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|||N|06/21/1985|11/27/1985|||APPR|
P830074|S005|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|||N|09/12/1985|08/04/1986|||APPR|
P830074|S006|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|||N|11/14/1985|07/17/1986|||APPR|
P830074|S007|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|||N|12/20/1985|05/05/1986|||APPR|
P830074|S009|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|Normal 180 Day Track|Other Report|N|10/22/1986|12/18/1986|||APPR|
P830074|S010|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|Normal 180 Day Track|Other Report|N|12/23/1986|03/30/1987|||APPR|
P830074|S011|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/18/1987|06/18/1987|||APPR|
P830074|S012|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/1987|11/25/1987|||APPR|
P830074|S013|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|Normal 180 Day Track|Other Report|N|08/25/1987|07/15/1988|||APPR|
P830074|S014|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/1987|05/05/1988|||APPR|
P830074|S015|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/1988|05/02/1988|||APPR|
P830074|S016|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/1988|06/30/1988|||APPR|
P830074|S017|GENERAL ELECTRIC CO.|P0 BOX 414||MILWAUKEE|WI|||System, nuclear magnetic resonance imaging|GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS|LNH|RA|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|07/18/1988|07/29/1988|||APPR|
P830076|S001|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|||N|03/08/1985|07/10/1985|||APPR|
P830076|S002|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|||N|03/22/1985|11/12/1985|||APPR|
P830076|S003|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|||N|01/09/1986|10/22/1986|||APPR|
P830076|S004|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|||N|01/16/1986|10/08/1986|||APPR|
P830076|S005|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|Normal 180 Day Track||N|03/31/1986|10/08/1986|||APPR|
P830076|S006|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|||N|04/21/1986|11/28/1986|||APPR|
P830076|S007|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/1986|12/05/1986|||APPR|
P830076|S008|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1987|06/22/1987|||APPR|
P830076|S009|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/1987|04/15/1988|||APPR|
P830076|S010|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1987|04/12/1988|||APPR|
P830076|S011|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/1987|04/12/1988|||APPR|
P830076|S012|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/12/1988|07/12/1988|||APPR|
P830076|S013|FONAR CORP.|110 MARCUS DR.||MELVILLE|NY|11747||System, nuclear magnetic resonance imaging|FONAR NMR WHOLE BODY SCANNER BETA 3000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/1988|05/24/1988|||APPR|
P830077|S001|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METRO 55 (METHAFILCON A)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/1988|02/21/1989|||APPR|
P830077|S002|METROSOFT, INC.|P.O. BOX 14847||AUSTIN|TX|78761|4847|Lenses, soft contact, daily wear|METRO 55 (METHAFILCON A)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1988|03/02/1989|||APPR|
P830079|S001|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|||N|11/07/1985|12/02/1985|||APPR|
P830079|S002|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Other Report|N|09/09/1986|01/21/1987|||APPR|
P830079|S003|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/1986|08/12/1987|||APPR|
P830079|S006|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/1988|07/18/1988|||APPR|
P830079|S007|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/1988|08/28/1989|||APPR|
P830079|S008|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/1990|03/22/1991|||APPR|
P830079|S009|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/1990|09/12/1990|||APPR|
P830079|S010|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/1990|08/28/1990|||APPR|
P830081|S001|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|||N|12/07/1984|07/10/1985|||APPR|
P830081|S002|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|||N|01/24/1985|03/08/1985|||APPR|
P830081|S003|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|||N|02/27/1985|06/06/1985|||APPR|
P830081|S004|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Other Report|N|03/18/1985|09/08/1986|||APPR|
P830081|S005|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|||N|04/25/1985|11/10/1986|||APPR|
P830081|S006|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|||N|01/13/1986|12/24/1986|||APPR|
P830081|S007|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|||N|03/21/1986|06/03/1986|||APPR|
P830081|S008|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/1986|03/26/1987|||APPR|
P830081|S009|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1986|12/23/1986|||APPR|
P830081|S010|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/09/1986|12/18/1986|||APPR|
P830081|S011|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/1987|05/05/1987|||APPR|
P830081|S012|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Other Report|N|03/19/1987|04/10/1987|||APPR|
P830081|S013|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Other Report|N|06/12/1987|12/29/1987|||APPR|
P830081|S014|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1987|08/26/1987|||APPR|
P830081|S015|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/1987|03/03/1988|||APPR|
P830081|S016|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|01/20/1988|02/19/1988|||APPR|
P830081|S017|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|03/28/1988|04/15/1988|||APPR|
P830081|S018|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/1988|05/24/1988|||APPR|
P830081|S019|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1988|07/12/1988|||APPR|
P830081|S022|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||System, nuclear magnetic resonance imaging|MAGNETOM|LNH|RA|Normal 180 Day Track|Other Report|N|07/07/1988|07/25/1988|||APPR|
P840001|S001|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track||N|01/18/1985|02/07/1985|||APPR|
P840001|S002|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track||N|02/13/1985|03/26/1985|||APPR|
P840001|S003|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|||N|03/20/1985|05/31/1985|||APPR|
P840001|S004|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track||N|04/10/1985|06/04/1985|||APPR|
P840001|S005|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|||N|11/07/1985|04/14/1986|||APPR|
P840001|S006|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|||N|04/04/1986|06/05/1986|||APPR|
P840001|S007|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|||N|04/11/1986|06/05/1986|||APPR|
P840001|S008|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/1986|07/14/1986|||APPR|
P840001|S009|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/1987|06/22/1987|||APPR|
P840001|S010|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/1987|08/05/1987|||APPR|
P840001|S011|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/1987|08/14/1987|||APPR|
P840001|S012|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/1988|09/15/1988|||APPR|
P840001|S013|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/1988|11/29/1988|||APPR|
P840001|S014|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/1988|11/10/1988|||APPR|
P840001|S015|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/1989|08/02/1989|||APPR|
P840001|S016|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/1989|12/08/1989|||APPR|
P840001|S017|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/1989|08/01/1989|||APPR|
P840001|S018|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL TOTALLY IMPLANTABLE  SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/18/1990|04/06/1990|||APPR|
P840001|S019|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL TOTALLY IMPLANTABLE  SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/1990|04/19/1990|||APPR|
P840001|S020|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL TOTALLY IMPLANTABLE  SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1990|09/27/1990|||APPR|
P840001|S021|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL TOTALLY IMPLANTABLE  SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1990|08/08/1990|||APPR|
P840001|S022|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1990|01/17/1992|||APPR|
P840001|S023|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC MODEL 7441NC CORDIS/ ITREL II ADAPTOR|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/1991|04/03/1991|||APPR|
P840001|S024|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC MODEL 7441NC CORDIS/ ITREL II ADAPTOR|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/1991|08/29/1991|||APPR|
P840001|S025|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL II MODELS 7495,7496,7441,7441NC|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1991|07/09/1992|||APPR|
P840001|S026|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC MODEL 7497 NEUROMED/MEDTRONIC ADAPTER|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1992|04/05/1993|||APPR|
P840001|S028|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC INTREL & INTREL II SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1992|03/31/1993|||APPR|
P840001|S029|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC INTREL & INTREL II SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1993|12/07/1993|||APPR|
P840001|S030|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC INTREL(R) SPINAL CORD STIMULATION SYS.|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/1994|05/25/1994|||APPR|
P840001|S031|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC INTREL(R) SPINAL CORD STIMULATION SYS.|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/15/1994|01/05/1995|||APPR|
P840001|S032|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC INTREL(R) SPINAL CORD STIMULATION SYS.|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/1994|10/17/1995|||APPR|APPROVAL FOR AN ALTERNATE BEAD BLAST FINISH
P840001|S034|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/1994|04/27/1995|||APPR|
P840001|S035|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1994|01/23/1995|||APPR|
P840002|S001|CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|STAT-PACE II|LPA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/1993|01/11/1994|||APPR|
P840004|S001|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|B&L (SYNERGICON A) SYNERCON(TM) CONTACT LENS|HPX|OP|||N|03/12/1985|04/18/1985|||APPR|
P840004|S002|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|SATURN II(TM) (SYNERGICON A) CONTACT LENS|HPX|OP|||N|04/17/1986|05/21/1986|||APPR|
P840004|S003|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|SATURN II(TM) (SYNERGICON A) CONTACT LENS|HPX|OP|THIRTY DAY TRACK|Other Report|N|11/25/1986|01/29/1987|||APPR|
P840004|S005|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|SATURN II(TM) (SYNERGICON A) CONTACT LENS|HPX|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/1989|12/06/1989|||APPR|
P840004|S006|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|SATURN II(TM) (SYNERGICON A) CONTACT LENS|HPX|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1992|05/13/1993|||APPR|
P840004|S007|WESLEY JESSEN CORP.|333 E. HOWARD AVE.||DES PLAINES|IL|60018|5903|Lens, contact (polymethylmethacrylate)|SATURN II(TM) (SYNERGICON A) CONTACT LENS|HPX|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/06/1992|10/14/1993|||APPR|
P840006|S001|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS|LPL|OP|||N|02/25/1985|05/17/1985|||APPR|
P840006|S002|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS|LPL|OP|||N|02/27/1985|10/10/1985|||APPR|
P840006|S004|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS|LPL|OP|Normal 180 Day Track|Other Report|N|08/02/1990|09/07/1990|||APPR|
P840006|S005|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1990|04/24/1991|||APPR|
P840006|S006|SALVATORI OPHTHALMICS MFG. CORP.|6416 PARKLAND DR.||SARASOTA|FL|34243||Lenses, soft contact, daily wear|SOF-FORM ALLVUE MULTIFOCAL (POLYMACON) CONTACT LEN|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1990|02/07/1991|||APPR|
P840007|S001|ELSCINT, INC.|930 COMMONWEALTH AVE.||BOSTON|MA|02215||System, nuclear magnetic resonance imaging|GYREX, MODELS S3500 & S5000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1986|04/02/1987|||APPR|
P840007|S002|ELSCINT, INC.|930 COMMONWEALTH AVE.||BOSTON|MA|02215||System, nuclear magnetic resonance imaging|GYREX, MODELS S3500 & S5000|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1987|10/08/1987|||APPR|
P840007|S003|ELSCINT, INC.|930 COMMONWEALTH AVE.||BOSTON|MA|02215||System, nuclear magnetic resonance imaging|GYREX|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1988|04/26/1988|||APPR|
P840008|S001|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track||N|10/31/1985|04/14/1986|||APRL|
P840008|S002|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track||N|11/22/1985|02/05/1986|||APRL|
P840008|S003|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track||N|12/24/1985|04/14/1986|||APRL|
P840008|S004|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track||N|02/28/1986|06/20/1986|||APRL|
P840008|S005|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|06/10/1986|08/27/1986|||APRL|
P840008|S006|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1986|05/06/1987|||APRL|
P840008|S007|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/03/1986|09/30/1986|||APRL|
P840008|S008|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Other Report|N|09/09/1986|05/06/1987|||APRL|
P840008|S009|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Other Report|N|12/12/1986|06/11/1987|||APRL|
P840008|S010|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/1987|09/17/1987|||APRL|
P840008|S011|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/13/1987|06/09/1987|||APRL|
P840008|S012|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1987|12/29/1987|||APRL|
P840008|S013|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1987|12/29/1987|||APRL|
P840008|S014|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Other Report|N|06/23/1987|12/31/1987|||APRL|
P840008|S015|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1987|02/03/1988|||APRL|
P840008|S016|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/1987|01/19/1989|||APRL|
P840008|S018|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/1987|07/16/1990|||APRL|
P840008|S019|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|05/09/1988|09/30/1988|||APRL|
P840008|S021|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/1989|10/19/1989|||APRL|
P840008|S023|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL HM3|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/1990|05/03/1990|||APRL|
P840008|S024|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL MFL5000|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/1990|07/03/1991|||APRL|
P840008|S025|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER, MODEL MFL5000|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/1990|07/03/1991|||APRL|
P840008|S026|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MPL 9000 - RENAL APPLICATION|LNS|GU|Panel Track|Change Design/Components/Specifications/Material|N|05/21/1990|08/12/1991|||APRL|
P840008|S027|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MPL 9000 - RENAL APPLICATION|LNS|GU|Normal 180 Day Track|Other Report|N|01/09/1991|01/18/1991|||APRL|
P840008|S028|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MPL 9000 - MOBILE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/11/1991|08/13/1991|||APRL|
P840008|S029|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER MODELS HM3 AND HM4|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1991|07/25/1991|||APRL|
P840008|S030|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER MODELS HM3 AND HM4|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1991|08/06/1991|||APRL|
P840008|S031|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER MODEL MFL 5000|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/1991|12/20/1991|||APRL|
P840008|S032|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER HM4 MOBILE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/26/1991|11/06/1991|||APRL|
P840008|S033|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MPL9000 LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/11/1991|10/04/1991|||APRL|
P840008|S034|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MODELS HM3 & HM4 LITHOTRIPTER|LNS|GU|Normal 180 Day Track||N|09/30/1991|01/02/1992|||APRL|
P840008|S035|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1991|01/02/1992|||APRL|
P840008|S037|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/03/1992|07/29/1992|||APRL|
P840008|S038|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MODELS MFL5000 SHOCK WAVE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1992|12/04/1992|||APRL|
P840008|S039|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MODELS MPL9000 MODIFICATIONS|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/04/1992|10/29/1992|||APRL|
P840008|S040|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|MODEL MFL5000 EXPANSION OF INDICATION RANGE|LNS|GU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/11/1992|03/08/1993|93M-0124||APRL|
P840008|S041|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|MODEL MFL5000 CHANGE TO ELECTRODE PACKAGE INSERT|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/1992|08/06/1992|||APRL|
P840008|S042|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|MODEL HM4 LITHOTRIPTER CHANGE KV SETTING|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/07/1992|12/08/1992|||APRL|
P840008|S044|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|MODEL MFL 5000 MOBILE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/1993|07/19/1993|||APRL|
P840008|S045|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|MODEL MFL 5000 LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/1993|04/12/1995|||APRL|
P840008|S046|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|MODEL MFL 5000 LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/1993|08/04/1993|||APRL|
P840008|S047|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER COMPACT|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1993|09/12/1994|||APRL|
P840008|S048|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER COMPACT|LNS|GU|Normal 180 Day Track|Other Report|N|04/18/1994|05/04/1994|||APRL|
P840008|S049|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER MFL5000 MOBILE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1994|07/27/1994|||APRL|
P840012|S001|MERIDIAN AG|BIERIGUTSTRAUSS 7|CH-3608|THUN, BE||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MICRORUPTOR MR-2 ND:YAG LASER SYSTEM|LOI|OP|||N|01/22/1986|05/30/1986|||APPR|
P840012|S002|MERIDIAN AG|BIERIGUTSTRAUSS 7|CH-3608|THUN, BE||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MICRORUPTOR MR-2 ND:YAG LASER SYSTEM|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/1987|06/22/1987|||APPR|
P840012|S003|MERIDIAN AG|BIERIGUTSTRAUSS 7|CH-3608|THUN, BE||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MICRORUPTOR MR-2 ND:YAG LASER SYSTEM|LOI|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/1987|08/27/1987|87M-0305|10/19/1987|APPR|
P840012|S005|MERIDIAN AG|BIERIGUTSTRAUSS 7|CH-3608|THUN, BE||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MICRORUPTOR MR-2 ND:YAG LASER SYSTEM|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/04/1988|10/26/1988|||APPR|
P840012|S006|MERIDIAN AG|BIERIGUTSTRAUSS 7|CH-3608|THUN, BE||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|LASAG TOPAZ ND:YAG LASER SYSTEM|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/1989|05/01/1990|||APPR|
P840012|S007|MERIDIAN AG|BIERIGUTSTRAUSS 7|CH-3608|THUN, BE||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|LASAG MICRORUPTOR III Q-SWITCH ND:YAG|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1989|04/05/1991|||APPR|
P840015|S001|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|||N|08/23/1985|10/31/1985|||APPR|
P840015|S002|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|||N|11/01/1985|12/13/1985|||APPR|
P840015|S003|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|||N|11/20/1985|04/15/1986|||APPR|
P840015|S004|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|||N|04/01/1986|06/12/1986|||APPR|
P840015|S005|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/14/1987|12/18/1987|||APPR|
P840015|S006|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/26/1987|01/21/1988|||APPR|
P840015|S007|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/1987|12/29/1987|||APPR|
P840015|S008|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/1987|02/19/1988|||APPR|
P840015|S009|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1987|12/29/1987|||APPR|
P840015|S010|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1987|02/29/1988|||APPR|
P840015|S011|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1987|04/05/1988|||APPR|
P840015|S012|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/1988|08/22/1988|||APPR|
P840015|S013|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV|LOC|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/30/1988|12/15/1988|||APPR|
P840015|S014|CLINI-THERM CORP.|11410 PAGEMILL RD.||DALLAS|TX|75243||System, rf/microwave hyperthermia, cancer treatment|CLINI-THERM MARK I/IV/ DIPOLE ARRAY APPLICATOR|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/1989|07/17/1990|||APPR|
P840019|S001|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY|DHX|IM|||N|08/01/1984|03/25/1985|||APPR|
P840019|S002|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY|DHX|IM|||N|03/29/1985|05/03/1985|||APPR|
P840019|S003|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY|DHX|IM|||N|08/23/1985|03/06/1986|||APPR|
P840019|S004|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY|DHX|IM|Normal 180 Day Track|Other Report|N|03/20/1986|09/23/1986|||APPR|
P840019|S005|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY|DHX|IM|Normal 180 Day Track|Other Report|N|09/17/1986|11/05/1986|||APPR|
P840019|S006|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/1987|04/30/1987|||APPR|
P840019|S007|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY|DHX|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/1989|09/06/1989|||APPR|
P840019|S008|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY|DHX|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/1989|12/13/1989|||APPR|
P840019|S009|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/1990|04/17/1990|||APPR|
P840019|S010|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/1991|03/17/1994|||APPR|
P840019|S011|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1992|01/13/1994|||APPR|
P840020|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES CHEMICAL DISINFECTANT|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/05/1987|06/16/1987|||APPR|
P840020|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES CHEMICAL DISINFECTANT|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1987|06/10/1987|||APPR|
P840020|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES CHEMICAL DISINFECTANT|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/1987|03/14/1991|||APPR|
P840024|S001|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|||N|11/19/1985|05/15/1986|||APPR|
P840024|S002|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|||N|05/15/1986|07/24/1986|||APPR|
P840024|S003|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Other Report|N|06/26/1986|10/24/1986|||APPR|
P840024|S005|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1986|12/31/1986|||APPR|
P840024|S006|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1987|09/02/1987|||APPR|
P840024|S007|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1987|09/02/1987|||APPR|
P840024|S008|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/11/1987|10/19/1987|||APPR|
P840024|S009|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/1987|08/27/1987|||APPR|
P840024|S010|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1987|08/31/1987|||APPR|
P840024|S011|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1987|10/19/1987|||APPR|
P840024|S012|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/1987|11/17/1987|||APPR|
P840024|S013|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1987|04/28/1988|||APPR|
P840024|S014|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/07/1987|03/29/1991|||APPR|
P840024|S015|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1987|07/07/1988|||APPR|
P840024|S017|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/1988|09/09/1988|||APPR|
P840024|S018|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/1988|05/16/1988|||APPR|
P840024|S019|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/13/1988|10/11/1989|||APPR|
P840024|S020|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/13/1989|04/14/1989|||APPR|
P840024|S021|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/1989|11/13/1989|||APPR|
P840024|S022|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1989|10/11/1989|||APPR|
P840024|S023|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1989|01/16/1990|||APPR|
P840024|S024|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/1990|06/08/1990|||APPR|
P840024|S025|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/1990|08/17/1990|||APPR|
P840024|S026|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/1990|10/25/1990|||APPR|
P840024|S027|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Other Report|N|08/16/1990|12/24/1990|||APPR|
P840024|S028|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/1990|07/28/1995|||APPR|APPROVAL FOR DISTRIBUTION OF THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT FOR PRELINGUISTICALLY & PERILINGUISTICALLY DEAFENED ADULTS
P840024|S029|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/12/1990|03/24/1992|||APPR|
P840024|S030|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1990|09/10/1991|||APPR|
P840024|S031|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1991|05/16/1991|||APPR|
P840024|S032|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/1991|08/15/1991|||APPR|
P840024|S033|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/1991|08/15/1991|||APPR|
P840024|S034|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/1991|03/09/1994|||APPR|
P840024|S035|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|OMIT ULTRASONIC WELD|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/1991|05/20/1993|||APPR|
P840024|S036|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|IF4 BOARD FOR THE DUAL PROCESSOR INTERFACE SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1991|09/14/1992|||APPR|
P840024|S037|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|LAPEL MICROPHONE/MINI SPEECH PROCESSER|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1991|05/21/1992|||APPR|
P840024|S038|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|COCHLEAR'S MINI 22 COCHLEAR IMPLANT (MODEL CI22M)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/1992|04/05/1993|||APPR|
P840024|S039|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|MAGNET OPTION (Z11020)      IMPLANT (MODEL CI22M)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1992|05/20/1993|||APPR|
P840024|S040|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/1992|07/07/1992|||APPR|
P840024|S041|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/1992|07/07/1992|||APPR|
P840024|S042|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1992|07/07/1992|||APPR|
P840024|S043|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1992|07/07/1992|||APPR|
P840024|S044|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMP DPS SOFTWARE|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1992|02/26/1993|||APPR|
P840024|S045|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/1992|03/09/1994|||APPR|
P840024|S046|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR|MCM|EN|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/1992|08/21/1995|95M-0398|12/19/1995|APPR|APPROVAL FOR NUCLEUS 22-CHANNEL COCHLEAR IMPLANT FOR USE IN AN EXPANDED ADULT POPULATION.
P840024|S047|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/08/1992|03/19/1993|||APPR|
P840024|S048|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|MINI SPEECH PROCESSOR|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/1993|04/28/1994|||APPR|
P840024|S049|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/07/1993|03/30/1994|||APPR|
P840024|S050|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1993|03/09/1994|||APPR|
P840024|S051|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1993|03/09/1994|||APPR|
P840024|S052|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/06/1994|09/27/1994|||APPR|
P840024|S053|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/1994|04/17/1995|||APPR|
P840024|S055|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1994|02/13/1996|||APPR|APPROVAL FOR COMPONENT AND PROCESS CHANGE TO THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE COMPONENT CHANGE CONSISTS OF REPLACING THE LOWER VALUE NPO DIELECTRIC TRIM CAPACITOR WITH THE SAME BX DIELECTRIC MATERIAL AS USED FOR THE HIGHER VALUE TRIM CAPACITOR. THE PROCESS CHANGE CONSISTS OF PREHEATING THE CAPACITORS AND PRINTED CIRCUIT BOARD PRIOR TO SOLDERING THE CAPACITORS TO THE PCB
P840025|S001|AMERICAN EDWARDS LABORATORIES|CLAYTON PROFESSIONAL BLDG.|SUITE 3A  118 NORTH STREET|ELKTON|MD|21921|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|GARREN GASTRIC BUBBLE|LTI|GU|||N|10/28/1985|12/18/1985|||APPR|
P840025|S002|AMERICAN EDWARDS LABORATORIES|CLAYTON PROFESSIONAL BLDG.|SUITE 3A  118 NORTH STREET|ELKTON|MD|21921|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|GARREN GASTRIC BUBBLE|LTI|GU|||N|11/04/1985|01/23/1986|||APPR|
P840025|S003|AMERICAN EDWARDS LABORATORIES|CLAYTON PROFESSIONAL BLDG.|SUITE 3A  118 NORTH STREET|ELKTON|MD|21921|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|GARREN GASTRIC BUBBLE|LTI|GU|||N|11/29/1985|01/23/1986|||APPR|
P840025|S004|AMERICAN EDWARDS LABORATORIES|CLAYTON PROFESSIONAL BLDG.|SUITE 3A  118 NORTH STREET|ELKTON|MD|21921|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|GARREN GASTRIC BUBBLE|LTI|GU|||N|12/16/1985|01/23/1986|||APPR|
P840025|S005|AMERICAN EDWARDS LABORATORIES|CLAYTON PROFESSIONAL BLDG.|SUITE 3A  118 NORTH STREET|ELKTON|MD|21921|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|GARREN{TM}-EDWARDS GASTRIC BUBBLE|LTI|GU|Normal 180 Day Track||N|03/27/1986|05/12/1986|||APPR|
P840025|S006|AMERICAN EDWARDS LABORATORIES|CLAYTON PROFESSIONAL BLDG.|SUITE 3A  118 NORTH STREET|ELKTON|MD|21921|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|GARREN GASTRIC BUBBLE|LTI|GU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/1986|07/25/1986|||APPR|
P840025|S008|AMERICAN EDWARDS LABORATORIES|CLAYTON PROFESSIONAL BLDG.|SUITE 3A  118 NORTH STREET|ELKTON|MD|21921|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|GARREN GASTRIC BUBBLE|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1986|10/16/1986|||APPR|
P840025|S011|AMERICAN EDWARDS LABORATORIES|CLAYTON PROFESSIONAL BLDG.|SUITE 3A  118 NORTH STREET|ELKTON|MD|21921|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|GARREN GASTRIC BUBBLE|LTI|GU|Special (Immediate Track)|Other Report|N|10/20/1986|03/17/1987|||APPR|
P840027|S001|ROCHE DIAGNOSTICS GMBH|1080 U.S. HWY. 202|BRANCHBURG TOWNSHIP|SOMERVILLE|NJ|08876|3771|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE(R) EIA|DHX|IM|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1986|09/08/1986|||APPR|
P840027|S002|ROCHE DIAGNOSTICS GMBH|1080 U.S. HWY. 202|BRANCHBURG TOWNSHIP|SOMERVILLE|NJ|08876|3771|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE(R) EIA|DHX|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/19/1986|02/19/1987|||APPR|
P840027|S003|ROCHE DIAGNOSTICS GMBH|1080 U.S. HWY. 202|BRANCHBURG TOWNSHIP|SOMERVILLE|NJ|08876|3771|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE(R) EIA|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1988|07/07/1988|||APPR|
P840027|S004|ROCHE DIAGNOSTICS GMBH|1080 U.S. HWY. 202|BRANCHBURG TOWNSHIP|SOMERVILLE|NJ|08876|3771|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE(R) EIA|DHX|IM|Normal 180 Day Track|Other Report|N|10/27/1988|11/29/1988|||APPR|
P840027|S005|ROCHE DIAGNOSTICS GMBH|1080 U.S. HWY. 202|BRANCHBURG TOWNSHIP|SOMERVILLE|NJ|08876|3771|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE(R) EIA|DHX|IM|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/1989|05/01/1989|||APPR|
P840027|S006|ROCHE DIAGNOSTICS GMBH|1080 U.S. HWY. 202|BRANCHBURG TOWNSHIP|SOMERVILLE|NJ|08876|3771|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|CEA-ROCHE(R) EIA|DHX|IM|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/1989|05/01/1989|||APPR|
P840029|S002|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|MICROVEL(R) WITH HEMASHIELD|DSY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/1990|07/18/1990|||APPR|
P840029|S004|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD ETS(TM) FLANGED GRAFT|DSY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/1990|05/17/1993|||APPR|
P840029|S005|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS|DSY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1991|05/11/1993|||APPR|
P840029|S006|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM|DSY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1991|05/17/1993|||APPR|
P840029|S007|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM|DSY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1991|05/17/1993|||APPR|
P840029|S008|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM|DSY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/06/1992|05/11/1993|||APPR|
P840029|S009|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS|DSY|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1992|05/11/1993|||APPR|
P840029|S010|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS|DSY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/04/1992|05/11/1993|||APPR|
P840029|S011|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470|||HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/1992|05/17/1993|||APPR|
P840029|S014|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT|DSY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/1992|05/17/1993|||APPR|
P840029|S015|MAQUET CARDIOVASCULAR, LLC|45 BARBOUR POND DRIVE||WAYNE|NJ|07470||PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER|HEMASHIELD(R) WOVEN DOUBLE VELOUR GRAFT|DSY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/1992|05/11/1993|||APPR|
P840031|S001|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|SAULFON PW-70 A&B|LPM|OP|||N|04/01/1985|04/17/1985|||APPR|
P840031|S003|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|SAULFON PW-70 A&B|LPM|OP|||N|08/22/1985|03/17/1986|||APPR|
P840031|S004|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|SAULFON PW-70 A&B|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/1987|06/10/1987|||APPR|
P840031|S006|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|SAULFON PW-70 A&B|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/1987|06/10/1987|||APPR|
P840031|S007|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|SAULFON PW-70 A&B|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/1988|10/03/1988|||APPR|
P840031|S008|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|SAULFON PW-70 A&B|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/1989|12/19/1989|||APPR|
P840033|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MODELS KR2V, SK21V, S2BV|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/1991|05/29/1992|||APPR|
P840033|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|LASER WELDING/RHAR,PMMA HAPTICS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/1992|05/05/1994|||APPR|
P840035|S001|BECKMAN COULTER, INC.|7330 CARROLL RD.|P.O. BOX 269006|SAN DIEGO|CA|92196||KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|TANDEM(R)-E AFP|LOJ|IM|||N|08/23/1985|03/06/1986|||APPR|
P840035|S002|BECKMAN COULTER, INC.|7330 CARROLL RD.|P.O. BOX 269006|SAN DIEGO|CA|92196||KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ENCORE AFP|LOJ|IM|||N|01/22/1986|04/08/1986|||APPR|
P840035|S003|BECKMAN COULTER, INC.|7330 CARROLL RD.|P.O. BOX 269006|SAN DIEGO|CA|92196||KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|TANDEM(R)-E AFP|LOJ|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/03/1986|04/29/1988|88M-0184|06/27/1988|APPR|
P840035|S004|BECKMAN COULTER, INC.|7330 CARROLL RD.|P.O. BOX 269006|SAN DIEGO|CA|92196||KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|TANDEM(R)-E AFP|LOJ|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/06/1986|09/02/1986|||APPR|
P840035|S006|BECKMAN COULTER, INC.|7330 CARROLL RD.|P.O. BOX 269006|SAN DIEGO|CA|92196||KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|TANDEM(R)-E AFP|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/04/1987|08/05/1987|||APPR|
P840035|S007|BECKMAN COULTER, INC.|7330 CARROLL RD.|P.O. BOX 269006|SAN DIEGO|CA|92196||KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|TANDEM(R)-E AFP|LOJ|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/06/1988|06/03/1988|||APPR|
P840037|S001|GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES|61 BURNES PARK RD. N., WALLING|FORD, CT 06492-0333|||||MONITOR, CARBON-DIOXIDE, CUTANEOUS|MODEL 515 NEONATAL MONIOTR|LKD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1986|11/19/1986|||APPR|
P840039|S002|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1987|09/21/1987|||APPR|
P840039|S003|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/30/1987|01/27/1988|||APPR|
P840039|S006|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|08/01/1988|08/21/1989|89M-0361|09/13/1989|APPR|
P840039|S007|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1988|10/12/1989|||APPR|
P840039|S012|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1988|10/12/1989|||APPR|
P840039|S013|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1988|11/06/1989|||APPR|
P840039|S015|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1988|01/08/1990|||APPR|
P840039|S018|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1988|10/27/1989|||APPR|
P840039|S021|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/1988|11/29/1989|||APPR|
P840039|S022|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1988|11/29/1989|||APPR|
P840039|S028|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1990|11/15/1990|||APPR|
P840039|S029|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J LOOP POSTERIOR CHAMBER TYPE II 0 & 10|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/1990|07/03/1990|||APPR|
P840039|S030|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|TIER A UV-ABSORBING POSTERIOR CHAMBER INTARA. LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/1991|02/07/1996|||APPR|APPROVAL FOR THE ADDITION OF D & C GREEN NO.6 DYE TO THE HAPTICS OF THE SINGLE-PIECE POLYMETHYLMETHACRYLATE (PMMA) IOLS UNDER THIS PMA AND MANUFACTURED FROM PMMA SUPPLIED FROM THE ST. LOUIS FACILITY
P840039|S031|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1991|02/07/1996|||APPR|APPROVAL FOR AN ADDITIONAL/ALTERNATEIVE VENDOR FOR POLYMETHYLMETHACRYLATE (PMMA) IWTH ULTRAVIOLET-ABSORBER CYASORB 24 AND NEW FORMULATION OF THE PMMA.
P840039|S032|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J-LOOP POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/08/1991|03/28/1994|||APPR|
P840039|S034|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|MODELS P328UV,P329UV,P351UV,P356UV, & P359UV LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/17/1992|03/31/1993|||APPR|
P840039|S035|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|MODEL P399UV (TIER A MODIFICATION)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1992|04/28/1993|||APPR|
P840039|S036|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1992|04/10/1992|||APPR|
P840039|S037|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J-LOOP POST.CHAM. IOL TYPE II|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1992|03/28/1994|||APPR|
P840039|S038|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J-LOOP POST.CHAM. IOL|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/27/1992|04/28/1993|||APPR|
P840039|S039|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|J-LOOP POST.CHAM. IOL  (WORLD DIST.)|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/27/1992|04/28/1993|||APPR|
P840039|S040|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1992|08/25/1994|||APPR|
P840039|S041|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/1992|08/09/1994|||APPR|
P840039|S042|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|MODEL 72NUV 1 PIECE POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1993|06/27/1994|||APPR|
P840039|S043|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|MODEL 71 UV 3 PIECE POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/1993|06/27/1994|||APPR|
P840039|S044|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|1 PIECE POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1993|10/25/1994|||APPR|
P840039|S045|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|ONE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/1993|01/10/1995|||APPR|
P840039|S046|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|ONE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/1994|07/29/1994|||APPR|
P840040|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|||N|01/03/1986|03/25/1986|||APPR|
P840040|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|||N|02/21/1986|07/11/1986|||APPR|
P840040|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/1987|02/19/1988|||APPR|
P840040|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1987|04/20/1988|||APPR|
P840040|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/1988|06/09/1988|||APPR|
P840040|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/24/1988|05/24/1988|||APPR|
P840040|S008|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1988|08/10/1988|||APPR|
P840040|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Other Report|N|06/13/1988|08/31/1988|||APPR|
P840040|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/1989|05/01/1989|||APPR|
P840040|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1989|11/01/1989|||APPR|
P840040|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/1989|12/14/1989|||APPR|
P840040|S013|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/1989|02/07/1990|||APPR|
P840040|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER 018 CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/1990|12/19/1990|||APPR|
P840040|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER 014 & SLIDER 018 BIFURCATED CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/1990|09/27/1990|||APPR|
P840040|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|GLIDER AND COATED GLIDER CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/1990|11/08/1990|||APPR|
P840040|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER .014 AND COATED GLIDER PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1990|11/19/1990|||APPR|
P840040|S019|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|GLIDER PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1990|11/14/1990|||APPR|
P840040|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PROACT TW PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/1990|01/31/1991|||APPR|
P840040|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|\EART TRAK,HART TRAK III,MAX TRAK,MAX TRAK DP,PROA|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/1990|12/10/1990|||APPR|
P840040|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|HEART TRAK PTCA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/1990|01/30/1991|||APPR|
P840040|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|HEART TRAK PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1990|03/08/1991|||APPR|
P840040|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|HEART TRAK PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/1990|07/12/1991|||APPR|
P840040|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|HEART TRAK PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1990|07/12/1991|||APPR|
P840040|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|HEART TRAK PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1991|05/30/1991|||APPR|
P840040|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETER EXTENSION OF SILICONE COATING|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/1991|02/25/1992|||APPR|
P840040|S028|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NITECH TM 018 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/1991|05/29/1992|||APPR|
P840040|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SYNERGY(TM)CONV. RAPID EXCHANGE PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/1991|01/12/1993|||APPR|
P840040|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER(TM) 018 CORONARY BALLOON DILITATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1992|07/13/1992|||APPR|
P840040|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER(TM) 018 CORONARY BALLOON SLEEVE MODIFI.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/1992|07/29/1992|||APPR|
P840040|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER(TM)/SUPER THIN CORONARY BALLOON DILATION C|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1992|04/28/1993|||APPR|
P840040|S033|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER(TM)/2.0 MM BALLOON DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/28/1992|11/20/1992|||APPR|
P840040|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NITECH(TM) CORONARY BALLOON DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/1992|12/30/1992|||APPR|
P840040|S035|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER(TM) STRETCH CORONARY BALL. DILITATION CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1992|12/30/1992|||APPR|
P840040|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SYNERGY(TM)II CONVERTIBLE RAPID EXCHANGE PTCA CATH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1992|03/17/1994|||APPR|
P840040|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SLIDER (TM)3.4F LONG BALLOON DILATATION  PTCA CATH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/1993|07/08/1993|||APPR|
P840040|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA BALLOON DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/1993|10/21/1993|||APPR|
P840040|S039|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SYNERGY(TM) CONVERTIBLE RAPID EXCHANGE PTCA CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/1993|08/17/1993|||APPR|
P840040|S040|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|POBA(TM) AND SAAVY(TM) PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/1993|06/24/1994|||APPR|
P840040|S041|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MIGHTY(TM) CORONARY BALLOON DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1993|11/07/1994|||APPR|
P840040|S042|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CORONARY BALLOON DILITATION CATHETERS PTCA|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1993|01/23/1995|||APPR|
P840040|S043|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|3.4F SYNERGY(TM) II LONG BALL. DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/11/1994|10/06/1994|||APPR|
P840040|S044|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SYNERGY(TM) CONVERTIBLE RAPID EXCHANGE PTCA CATH|LOX|CV|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/1994|07/26/1994|||APPR|
P840040|S045|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|2.9F-TO-3.4F ALLY(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/1994|09/30/1994|||APPR|
P840040|S046|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MIGHTY(TM) PTCA BALLOON DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1994|09/27/1994|||APPR|
P840041|S001|DAVIS & GECK, INC.|ONE CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NOVAFIL(TM)|GAS|SU|Normal 180 Day Track|Other Report|N|11/04/1986|01/13/1987|||APPR|
P840041|S002|DAVIS & GECK, INC.|ONE CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NOVAFIL(TM)|GAS|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1987|06/05/1987|||APPR|
P840041|S003|DAVIS & GECK, INC.|ONE CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NOVAFIL(TM)|GAS|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/1988|07/06/1990|||APPR|
P840041|S004|DAVIS & GECK, INC.|ONE CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NOVAFIL(TM)|GAS|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/09/1989|08/08/1989|||APPR|
P840041|S005|DAVIS & GECK, INC.|ONE CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NOVAFIL(TM)|GAS|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1993|04/20/1994|||APPR|
P840044|S001|Toray Industries (America), Inc.|1-1-1 SONOYAMA||OTSU-SHI, SHIGA-KEN 520||520||Lenses, soft contact, extended wear|TORAY SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/1989|12/19/1989|||APPR|
P840044|S002|Toray Industries (America), Inc.|1-1-1 SONOYAMA||OTSU-SHI, SHIGA-KEN 520||520||Lenses, soft contact, extended wear|TORAY SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/1989|02/01/1990|||APPR|
P840045|S002|MEDICEM TECHNOLOGY S.R.O|KARLOVARSHA TRIDA 20||KAMENNE ZEHROVICE||27301||dilator, cervical, synthetic, osmotic, pregnancy termination|DILAPAN(TM)|LOB|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/1987|09/28/1988|||APPR|
P840045|S003|MEDICEM TECHNOLOGY S.R.O|KARLOVARSHA TRIDA 20||KAMENNE ZEHROVICE||27301||dilator, cervical, synthetic, osmotic, pregnancy termination|DILAPAN(TM)|LOB|OB|Normal 180 Day Track|Other Report|N|08/21/1987|12/14/1987|||APPR|
P840047|S001|COOPERVISION-CILCO|1616 13TH AVE., HUNTINGTON, W.|VA|||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|CILCO ND:YAG LASER|LOI|OP|||N|09/06/1985|11/26/1985|||APPR|
P840047|S002|COOPERVISION-CILCO|1616 13TH AVE., HUNTINGTON, W.|VA|||||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|CILCO ND:YAG LASER|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/1986|01/09/1987|||APPR|
P840049|S001|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER|P.C.A.(TM) TOTAL KNEE SYSTEM|HRY|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/1989|09/10/1991|||APPR|
P840050|S001|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track||N|11/01/1985|12/09/1985|||APPR|
P840050|S002|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK||N|12/10/1985|07/02/1987|||APPR|
P840050|S003|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track||N|02/28/1986|04/14/1986|||APPR|
P840050|S005|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track||N|05/08/1986|05/21/1986|||APPR|
P840050|S006|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/1986|08/11/1986|||APPR|
P840050|S008|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|08/27/1986|10/01/1986|||APPR|
P840050|S009|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|10/15/1986|11/14/1986|||APPR|
P840050|S010|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|12/03/1986|12/31/1986|||APPR|
P840050|S011|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|02/04/1987|05/05/1987|||APPR|
P840050|S012|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|04/06/1987|05/26/1987|||APPR|
P840050|S013|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/1987|09/28/1987|||APPR|
P840050|S014|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|05/13/1987|06/22/1987|||APPR|
P840050|S015|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|07/21/1987|08/12/1987|||APPR|
P840050|S016|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|07/31/1987|10/19/1987|||APPR|
P840050|S017|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|08/17/1987|09/21/1987|||APPR|
P840050|S018|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|08/19/1987|09/09/1987|||APPR|
P840050|S019|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|08/25/1987|09/09/1987|||APPR|
P840050|S020|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|09/16/1987|10/13/1987|||APPR|
P840050|S021|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|09/30/1987|10/27/1987|||APPR|
P840050|S022|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|10/05/1987|10/27/1987|||APPR|
P840050|S023|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1987|12/04/1987|||APPR|
P840050|S024|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1987|12/01/1987|||APPR|
P840050|S025|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/1987|12/01/1987|||APPR|
P840050|S026|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1987|02/04/1988|||APPR|
P840050|S027|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/1987|01/22/1988|||APPR|
P840050|S028|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/1987|01/11/1988|||APPR|
P840050|S029|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/1987|01/22/1988|||APPR|
P840050|S030|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1988|03/18/1988|||APPR|
P840050|S031|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|02/10/1988|05/05/1988|||APPR|
P840050|S032|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|03/02/1988|03/17/1988|||APPR|
P840050|S033|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/1988|05/05/1988|||APPR|
P840050|S034|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/1988|05/26/1988|||APPR|
P840050|S035|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/1988|08/09/1988|||APPR|
P840050|S036|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/1988|08/09/1988|||APPR|
P840050|S037|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/1988|09/22/1988|||APPR|
P840050|S038|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/1988|09/26/1988|||APPR|
P840050|S039|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/1988|11/10/1988|||APPR|
P840050|S040|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/04/1989|02/21/1989|||APPR|
P840050|S041|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/1989|02/21/1989|||APPR|
P840050|S042|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/1989|01/31/1990|||APPR|
P840050|S043|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(TM) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/1990|05/10/1990|||APPR|
P840050|S044|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(R) (NEFOCON A) CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/1992|03/23/1992|||APPR|
P840050|S045|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|intraocular lens|OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/1992|06/26/1992|||APPR|
P840050|S046|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/1992|07/09/1992|||APPR|
P840050|S047|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/1992|10/29/1992|||APPR|
P840050|S048|O.S.I. CORP.|601 GATEWAY BLVD.,#1050,||SOUTH SAN FRANCISCO|CA|94080|0000|Lens, contact (other material) - daily|OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/04/1993|04/14/1993|||APPR|
P840051|S001|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU|GAM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1987|06/05/1987|||APPR|
P840051|S003|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU|GAM|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/1989|06/07/1989|||APPR|
P840051|S004|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU|GAM|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/1991|03/29/1991|||APPR|
P840051|S005|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU|GAM|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/1991|10/17/1991|||APPR|
P840051|S006|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU|GAM|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/1991|03/24/1992|||APPR|
P840054|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Sterilizer, soft-lens, thermal, ac-powered|MODEL NO. ALS-IV  HEAT DISINFECTION UNIT|HRD|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/04/1987|05/10/1988|||APPR|
P840055|S001|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/1986|03/24/1987|||APPR|
P840055|S002|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/1986|04/16/1987|||APPR|
P840055|S003|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|THIRTY DAY TRACK|Other Report|N|12/03/1986|04/27/1987|||APPR|
P840055|S004|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|THIRTY DAY TRACK|Other Report|N|01/14/1987|05/12/1987|||APPR|
P840055|S005|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Other Report|N|02/09/1987|05/26/1987|||APPR|
P840055|S006|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|THIRTY DAY TRACK|Other Report|N|03/12/1987|05/26/1987|||APPR|
P840055|S007|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|THIRTY DAY TRACK|Other Report|N|05/15/1987|06/11/1987|||APPR|
P840055|S008|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/1987|12/08/1987|||APPR|
P840055|S009|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/1988|05/10/1988|||APPR|
P840055|S010|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/1988|05/03/1988|||APPR|
P840055|S011|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/1988|10/19/1988|||APPR|
P840055|S012|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1988|06/23/1989|||APPR|
P840055|S013|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Other Report|N|02/17/1989|03/17/1989|||APPR|
P840055|S014|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/1989|09/08/1989|||APPR|
P840055|S015|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1989|10/02/1990|||APPR|
P840055|S016|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP LENS(TM)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/1989|04/11/1990|||APPR|
P840055|S017|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/1990|03/15/1990|||APPR|
P840055|S018|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/1990|07/05/1990|||APPR|
P840055|S019|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/1990|10/31/1990|||APPR|
P840055|S020|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/1990|10/31/1990|||APPR|
P840055|S021|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|THIRTY DAY TRACK|Other Report|N|11/08/1990|12/12/1990|||APPR|
P840055|S022|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/1991|05/06/1991|||APPR|
P840055|S023|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/1991|08/07/1991|||APPR|
P840055|S024|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1991|01/14/1992|||APPR|
P840055|S025|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/1992|04/14/1992|||APPR|
P840055|S026|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1992|09/30/1992|||APPR|
P840055|S027|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1992|11/30/1992|||APPR|
P840055|S028|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/1992|01/31/1994|||APPR|
P840055|S029|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1992|12/04/1992|||APPR|
P840055|S030|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/1992|07/12/1993|||APPR|
P840055|S031|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1993|05/27/1993|||APPR|
P840055|S032|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1993|02/04/1994|||APPR|
P840060|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|||N|11/05/1985|08/29/1986|||APPR|
P840060|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|||N|04/08/1986|09/29/1986|||APPR|
P840060|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1986|12/03/1986|||APPR|
P840060|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1987|11/03/1987|||APPR|
P840060|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/1987|05/09/1988|||APPR|
P840060|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1987|05/03/1988|||APPR|
P840060|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/1987|05/03/1988|||APPR|
P840060|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|CR-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/1988|03/02/1988|||APPR|
P840060|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/1988|08/10/1989|||APPR|
P840060|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1988|08/10/1989|||APPR|
P840060|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/30/1988|09/07/1989|||APPR|
P840060|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|SM-1, CR-1, & GR-1 IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/1989|09/07/1989|||APPR|
P840060|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|IOL LENS MODEL GR1A|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/25/1991|03/24/1992|||APPR|
P840060|S018|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|IOL LENS MODEL GR1A|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/1991|05/29/1992|||APPR|
P840060|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P840060|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1993|02/20/1996|||APPR|APPROVAL FOR A NUMBER OF TIER A MODELS. THE MODELS LISTED IN ATTACHMENT 1 ARE INTENDED FOR BOTH CILIARY SULCUS AND CAPSULAR BAG IMPLANTATION; MODELS LX10BD AND MZ40BD ARE INTENDED FOR CAPSULAR BAG IMPLANTATION ONLY
P840062|S001|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(TM)|LPG|DE|Normal 180 Day Track||N|11/27/1985|03/13/1986|||APPR|
P840062|S002|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS|LPG|DE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/1990|05/08/1990|||APPR|
P840062|S003|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS|LPG|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/1991|03/27/1992|||APPR|
P840062|S004|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS|LPG|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/1992|06/24/1993|||APPR|
P840063|S001|PHILIPS MEDICAL SYSTEMS, INC.|710 BRIDGEPORT AVE.|P.O. BOX 860|SHELTON|CT|06484||System, nuclear magnetic resonance imaging|GYROSCAN(TM)|LNH|RA|Normal 180 Day Track|Other Report|N|10/16/1986|03/03/1987|||APPR|
P840063|S002|PHILIPS MEDICAL SYSTEMS, INC.|710 BRIDGEPORT AVE.|P.O. BOX 860|SHELTON|CT|06484||System, nuclear magnetic resonance imaging|GYROSCAN(TM)|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1986|01/30/1987|||APPR|
P840063|S003|PHILIPS MEDICAL SYSTEMS, INC.|710 BRIDGEPORT AVE.|P.O. BOX 860|SHELTON|CT|06484||System, nuclear magnetic resonance imaging|GYROSCAN(TM)|LNH|RA|Normal 180 Day Track|Other Report|N|11/07/1986|04/08/1987|||APPR|
P840063|S004|PHILIPS MEDICAL SYSTEMS, INC.|710 BRIDGEPORT AVE.|P.O. BOX 860|SHELTON|CT|06484||System, nuclear magnetic resonance imaging|GYROSCAN(TM)|LNH|RA|Special (Immediate Track)|Other Report|N|04/08/1987|07/13/1987|||APPR|
P840063|S005|PHILIPS MEDICAL SYSTEMS, INC.|710 BRIDGEPORT AVE.|P.O. BOX 860|SHELTON|CT|06484||System, nuclear magnetic resonance imaging|GYROSCAN(TM)|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/1987|08/11/1987|||APPR|
P840063|S006|PHILIPS MEDICAL SYSTEMS, INC.|710 BRIDGEPORT AVE.|P.O. BOX 860|SHELTON|CT|06484||System, nuclear magnetic resonance imaging|GYROSCAN(TM)|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/1987|05/05/1988|||APPR|
P840063|S007|PHILIPS MEDICAL SYSTEMS, INC.|710 BRIDGEPORT AVE.|P.O. BOX 860|SHELTON|CT|06484||System, nuclear magnetic resonance imaging|GYROSCAN(TM)|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/1987|05/02/1988|||APPR|
P840064|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/1986|03/06/1987|||APPR|
P840064|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/08/1986|03/02/1987|||APPR|
P840064|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/1987|04/27/1987|||APPR|
P840064|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/1987|10/27/1987|||APPR|
P840064|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1987|11/04/1987|||APPR|
P840064|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/21/1987|12/01/1987|||APPR|
P840064|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/1989|03/29/1990|||APPR|
P840064|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/1989|08/29/1990|||APPR|
P840064|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1990|03/19/1991|||APPR|
P840064|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/1990|12/12/1990|||APPR|
P840064|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/28/1993|08/17/1994|||APPR|
P840066|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1986|12/01/1986|||APPR|
P840066|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/1986|11/10/1987|||APPR|
P840066|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Other Report|N|04/24/1987|03/29/1988|||APPR|
P840066|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/1987|05/05/1988|||APPR|
P840066|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/1987|12/01/1987|||APPR|
P840066|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/1987|04/14/1988|||APPR|
P840066|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/1987|03/31/1988|||APPR|
P840066|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1988|07/14/1988|||APPR|
P840066|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/1988|07/28/1988|||APPR|
P840066|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/1988|08/08/1988|||APPR|
P840066|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/1988|08/09/1988|||APPR|
P840066|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/1988|08/16/1988|||APPR|
P840066|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/1988|10/28/1988|||APPR|
P840066|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/06/1989|08/23/1989|||APPR|
P840066|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/1989|11/03/1989|||APPR|
P840066|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/1989|01/31/1990|||APPR|
P840066|S021|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/1989|11/14/1989|||APPR|
P840066|S022|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1990|06/05/1990|||APPR|
P840066|S023|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) CONSEPT R-2 NEUTRALIZING & RINSING|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/07/1990|08/15/1990|||APPR|
P840066|S024|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(R) CONSEPT R-2 NEUTRALIZING & RINSING|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/1990|05/28/1991|||APPR|
P840066|S026|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|PRESERVED SOFT MATE(R) CONSEPT(R)2 NEUT.& RINS SOL|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/1990|01/18/1991|||APPR|
P840066|S027|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|PRESERVED SOFT MATE(R) CONSEPT(R)2 NEUT.& RINS SOL|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1990|04/13/1994|||APPR|
P840066|S028|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|PRESERVED SOFT MATE(R) CONSEPT(R)2 NEUT.& RINS SOL|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/1991|03/31/1994|||APPR|
P840066|S029|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|UNPRESERVED CONSEPT-2 RINSING & NEUTRALIZING SOL.|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1991|02/29/1996|||APPR|APPROVAL FOR THE UNPRESERVED FORMULATION OF CONSEPT-2 NEUTRALIZING AND RINSING SOLUTION TO BE PACKAGED IN A NON-AEROSOL MULTI-DOSE 8 AND 12 FLUID PZ CONTAINERS WITH A FILTER/VALVE CLOSURE SYSTEM LABELED WITH A DISCARD DATE OF 60 DAYS
P840066|S030|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(TM)CONCEPT CLEANING & DISINFECTING SOLUT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/1991|01/07/1993|||APPR|
P840066|S031|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE(TM)CONCEPT CLEANING & DISINFECTING SOLUT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/1991|11/04/1993|||APPR|
P840066|S032|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/06/1991|12/26/1991|||APPR|
P840068|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 925, 2040, 2041, 6564|LWP|CV|||N|01/16/1986|04/15/1986|||APPR|
P840068|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 925, 2040, 2041, 6564|LWP|CV|||N|03/20/1986|06/30/1986|||APPR|
P840068|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 925, 2040, 2041, 6564|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1986|06/26/1987|||APPR|
P840068|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 925, 2040, 2041, 6564|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/1987|04/12/1988|||APPR|
P840068|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 925, 2040, 2041, 6564|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1988|07/07/1988|||APPR|
P840068|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 925, 2040, 2041, 6564|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1988|02/21/1989|||APPR|
P840068|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 925, 2040, 2041, 6564|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/1988|10/07/1988|||APPR|
P840068|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 940 & 941 VISTA DDD GEN. & MODEL 2050 MODUL|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/1989|06/13/1990|||APPR|
P840068|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 6577 STERILIZABLE TELEMETY WAND|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1989|01/11/1990|||APPR|
P840068|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1989|05/23/1990|||APPR|
P840068|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD|LWP|CV|Normal 180 Day Track|Other Report|N|01/25/1990|02/21/1990|||APPR|
P840068|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/1990|05/17/1991|||APPR|
P840068|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 446 & 447 VISTA T,MODEL 940 & 941 VISTA DDD|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/1990|08/31/1990|||APPR|
P840068|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 446 & 447 VISTA T,MODEL 940 & 941 VISTA DDD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1990|08/23/1990|||APPR|
P840068|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 6577 STERILIZABLE TELEMETRY WAND|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1991|11/20/1991|||APPR|
P840068|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 925 DELTA PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1991|12/09/1991|||APPR|
P840068|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ALTERNATE STERILIZATION /VISTA(TM)T PRODUCTS|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/1991|07/26/1994|||APPR|
P840068|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA(R) PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/1992|02/05/1993|||APPR|
P840068|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/05/1992|06/19/1996|||APPR|APPROVAL FOR TWO NEW MODELS OF VISTA DDD PULSE GENERATORS AND A SOFTWARE MODULE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME VISTA DDD MODEL 942, VISTA DDD MODEL 944 AND SOFTWARE MODULE MODEL 2052 WITH THE COMMERCIALLY AVAILABLE HANDHELD PROGRAMMER MODEL 2035
P840068|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA(R) PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/1992|12/08/1994|||APPR|
P840068|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DDD PACEMAKER SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/1993|10/21/1994|||APPR|
P840068|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR SSI PACEMAKER SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/1993|03/15/1995|||APPR|
P840069|S001|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHARTER LABS SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/1986|05/19/1987|||APPR|
P840069|S002|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHARTER LABS SALINE SOLUTION|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|05/11/1987|09/09/1987|||APPR|
P840069|S003|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHARTER LABS SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1987|09/30/1987|||APPR|
P840069|S004|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHARTER LABS SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/31/1987|04/01/1988|||APPR|
P840069|S005|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHARTER LABS SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1988|07/29/1988|||APPR|
P840069|S006|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHARTER LABS SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|11/07/1989|||APPR|
P840070|S001|ORGANON TEKNIKA CORP.|100 AKZO AVE.||DURHAM|NC|27712||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST|LOM|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/1989|03/21/1990|||APPR|
P840071|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|TINTED TETRAFILCON A CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/1987|10/27/1987|||APPR|
P850001|S001|COOPERVISION, INC.|NORTE INDUSTRIAL PARK|CARR 362, KM 0.5|SAN GERMAN|PR|00753||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|HORIZON(TM) YAG LASER MODEL 2000|LOI|OP|||N|07/23/1985|10/22/1985|||APPR|
P850001|S002|COOPERVISION, INC.|NORTE INDUSTRIAL PARK|CARR 362, KM 0.5|SAN GERMAN|PR|00753||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|HORIZON(TM) YAG LASER MODEL 2000|LOI|OP|||N|03/25/1985|09/18/1985|||APPR|
P850001|S003|COOPERVISION, INC.|NORTE INDUSTRIAL PARK|CARR 362, KM 0.5|SAN GERMAN|PR|00753||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|HORIZON(TM) YAG LASER MODEL 2000|LOI|OP|||N|09/03/1985|10/03/1985|||APPR|
P850001|S005|COOPERVISION, INC.|NORTE INDUSTRIAL PARK|CARR 362, KM 0.5|SAN GERMAN|PR|00753||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|HORIZON(TM) YAG LASER MODEL 2000|LOI|OP|||N|05/20/1986|06/20/1986|||APPR|
P850001|S006|COOPERVISION, INC.|NORTE INDUSTRIAL PARK|CARR 362, KM 0.5|SAN GERMAN|PR|00753||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|HORIZON(TM) YAG LASER MODEL 2000|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/1986|12/01/1986|||APPR|
P850001|S007|COOPERVISION, INC.|NORTE INDUSTRIAL PARK|CARR 362, KM 0.5|SAN GERMAN|PR|00753||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|HORIZON(TM) YAG LASER MODEL 2000|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/1986|04/20/1987|87M-0158|06/08/1987|APPR|
P850001|S009|COOPERVISION, INC.|NORTE INDUSTRIAL PARK|CARR 362, KM 0.5|SAN GERMAN|PR|00753||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|HORIZON(TM) YAG LASER MODEL 2000|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/1987|10/27/1987|||APPR|
P850002|S001|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lenses, soft contact, daily wear|ALGES(TM) (HEFILCON A) CONTACT LENS|LPL|OP|||N|08/13/1985|02/28/1986||04/28/1986|APPR|
P850002|S002|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lenses, soft contact, daily wear|ALGES(TM) (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/1988|09/22/1988|||APPR|
P850002|S003|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lenses, soft contact, daily wear|ALGES(TM) (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/1988|03/23/1989|||APPR|
P850002|S005|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lenses, soft contact, daily wear|ALGES(TM) (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1989|06/06/1989|||APPR|
P850002|S006|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lenses, soft contact, daily wear|ALGES(TM) (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/1991|06/12/1991|||APPR|
P850002|S007|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lenses, soft contact, daily wear|ALGES(TM) (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/1991|08/28/1991|||APPR|
P850002|S008|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lenses, soft contact, daily wear|UNILENS   (HEFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/13/1991|11/17/1993|||APPR|
P850002|S009|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lenses, soft contact, daily wear|SIMULVUE  (HEFILCON A) BIFOCAL CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/13/1991|11/17/1993|||APPR|
P850007|S001|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|AME BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/1986|09/10/1986|||APPR|
P850007|S002|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|AME BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/1986|12/23/1986|||APPR|
P850007|S003|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|AME BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1987|07/20/1987|||APPR|
P850007|S004|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|AME BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1987|10/13/1987|||APPR|
P850007|S005|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|AME BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/28/1988|02/19/1988|||APPR|
P850007|S006|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|AME BONE GROWTH STIMULATOR|LOF|OR|Panel Track|Other Report|N|06/06/1988|02/07/1990|90M-0067|03/08/1990|APPR|
P850007|S007|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|AME BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/1989|03/24/1989|||APPR|
P850007|S008|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|MODEL 8500 AME BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1989|04/25/1990|||APPR|
P850007|S010|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM(R)|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/1990|12/06/1993|||APPR|
P850007|S011|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM(R)|LOF|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/1990|02/15/1991|||APPR|
P850007|S012|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM(TM)|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/1991|06/27/1991|||APPR|
P850007|S013|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM(TM)|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/1992|07/29/1993|||APPR|
P850007|S014|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|SPINAL-STIM(R)|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/1994|09/19/1996|||APPR|COMPANY PROVIDED FINAL DRAFT LABELING MODIFIED TO REFLECT THE LONG-TERM SUCCESS RATES FOR THE DEVICE. TRADE NAME:SPINAL-STIM
P850008|S001|Unilens Corp., USA|10431 72ND ST. NORTH|P.O. BOX 2530|LARGO|FL|34647||Lens, contact (polymethylmethacrylate)|THE BOSTON LENS II ALGES(R) BIFOCAL CONTACT LENS|HPX|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/14/1986|12/01/1986|||APPR|
P850009|S001|CENTOCOR, INC.|200 GREAT VALLEY PKWY.||MALVERN|PA|19355|1307|TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)|CA 125 ANTIBODY RIA|LTK|IM|Normal 180 Day Track|Other Report|N|06/08/1987|07/28/1987|||APPR|
P850009|S002|CENTOCOR, INC.|200 GREAT VALLEY PKWY.||MALVERN|PA|19355|1307|TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)|CA 125 ANTIBODY RIA|LTK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/1989|02/13/1990|||APPR|
P850009|S004|CENTOCOR, INC.|200 GREAT VALLEY PKWY.||MALVERN|PA|19355|1307|TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)|CA 125 ANTIBODY RIA|LTK|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/1990|03/28/1991|||APPR|
P850009|S005|CENTOCOR, INC.|200 GREAT VALLEY PKWY.||MALVERN|PA|19355|1307|TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)|CA 125 ANTIBODY RIA|LTK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/23/1992|07/15/1992|||APPR|
P850009|S006|CENTOCOR, INC.|200 GREAT VALLEY PKWY.||MALVERN|PA|19355|1307|TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)|CA 125 ANTIBODY RIA|LTK|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/1993|03/23/1994|||APPR|
P850009|S007|CENTOCOR, INC.|200 GREAT VALLEY PKWY.||MALVERN|PA|19355|1307|TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)|CA 125 ANTIBODY RIA|LTK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/1993|12/21/1994|||APPR|
P850010|S001|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|||N|12/13/1985|01/17/1986|||APPR|
P850010|S002|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|06/19/1986|08/18/1986|||APPR|
P850010|S003|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1986|09/22/1986|||APPR|
P850010|S004|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/1986|03/31/1987|||APPR|
P850010|S005|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/1987|08/13/1987|||APPR|
P850010|S006|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/1987|02/17/1987|||APPR|
P850010|S007|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/02/1987|08/03/1987|||APPR|
P850010|S010|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1988|02/09/1989|||APPR|
P850010|S011|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELITENE (R) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/1990|02/28/1990|||APPR|
P850010|S012|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/1990|06/22/1990|||APPR|
P850010|S013|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/18/1991|03/27/1992|||APPR|
P850010|S014|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/1992|06/08/1993|||APPR|
P850012|S001|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC|LPN|OP|Normal 180 Day Track|Other Report|N|05/11/1987|09/21/1987|||APPR|
P850012|S002|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1987|03/14/1988|||APPR|
P850012|S003|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1988|07/29/1988|||APPR|
P850012|S004|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1988|08/08/1988|||APPR|
P850012|S005|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|11/07/1989|||APPR|
P850019|S001|LASER MEDIA|77 ARKAY DR.||HAUPPAUGE|NY|11788||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|PHOTOTOME(TM) SYSTEM 2700|LOI|OP|||N|10/28/1985|12/24/1985|||APPR|
P850019|S002|LASER MEDIA|77 ARKAY DR.||HAUPPAUGE|NY|11788||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|PHOTOTOME(TM) SYSTEM 2700|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/1986|01/09/1987|||APPR|
P850020|S003|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA(TM) COLUMN|LKN|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/1990|02/06/1991|||APPR|
P850020|S004|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA(TM) COLUMN|LKN|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/1992|02/20/1993|||APPR|
P850020|S005|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA(TM) COLUMN|LKN|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1993|04/29/1993|||APPR|
P850020|S006|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA(TM) COLUMN|LKN|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/1993|04/29/1993|||APPR|
P850020|S008|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA(TM) COLUMN|LKN|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/12/1994|09/27/1996|||APPR|APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT (I.E., REVISIONS TO THE SECTIONS ENTITLED COLUMN PREPARATION, OFF-LINE PROCEDURE AND ON-LINE PROCEDURE, INCLUDING MORE DETAILED INSTRUCTIONS FOR USE, ILLUSTRATIONS OF THE DEVICE SET-UP, INCREASED PATIENT MONITORING AND REFINEMENT OF SPECIFIED PLASMA FLOW RATES) AND A PROCEDURE CHANGE INVOLVING THE USE OF AN "IN-LINE" LEUKOCYTE REMOVAL FILTR FOR MICROAGGREGATE REMOVAL WHICH IS TO BE INSERTED IN TE BLOOD LINE RETURNING TREATED PLASMA TO THE PATIENT
P850021|S001|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Other Report|N|11/28/1986|01/08/1987|||APPR|
P850021|S002|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/1987|03/02/1988|||APPR|
P850021|S003|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/1987|09/16/1987|||APPR|
P850021|S004|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Other Report|N|10/09/1987|06/06/1988|||APPR|
P850021|S005|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1988|06/22/1988|||APPR|
P850021|S006|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/29/1988|02/02/1989|||APPR|
P850021|S007|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1989|04/03/1990|||APPR|
P850021|S008|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/1989|04/30/1990|||APPR|
P850021|S009|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1989|06/22/1990|||APPR|
P850021|S010|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|1MER, ED. LABS. PTCA|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/1990|11/14/1990|||APPR|
P850021|S011|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETER WITH 3.5 MM BALLOON|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/1990|12/18/1990|||APPR|
P850021|S012|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|02/04/1991|||APPR|
P850021|S013|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|THE INTREPID(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1990|04/22/1991|||APPR|
P850021|S014|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMERICAN EDWARDS LABS HYBRID PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/15/1991|09/16/1991|||APPR|
P850021|S015|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMERICAN EDWARDS LABS HYBRID PTCA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/1991|03/04/1992|||APPR|
P850021|S016|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|REACH(TM).14 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/15/1991|01/07/1992|||APPR|
P850021|S017|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SLINKY(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/28/1991|02/14/1992|||APPR|
P850021|S018|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SLINKY(TM),EDGE(TM),QUICK(TM),PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/1991|01/22/1993|||APPR|
P850021|S019|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|REACH(TM).14 PTCA CATH.1.5MM & 4.0MM BALL. SIZES|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1991|03/13/1992|||APPR|
P850021|S020|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|LONG REACH(TM) 30MM PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/1992|01/29/1993|||APPR|
P850021|S021|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|OEACH(TM).14,& READY(TM).14,PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/1992|02/04/1994|||APPR|
P850021|S022|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|REACH(TM).14 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/1992|07/01/1993|||APPR|
P850021|S023|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID (TM)&QUICK(TM) 14 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/1992|02/10/1994|||APPR|
P850021|S024|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/1993|10/25/1993|||APPR|
P850021|S025|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1993|07/26/1994|||APPR|
P850021|S026|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/1994|07/26/1994|||APPR|
P850021|S027|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/1994|12/13/1994|||APPR|
P850021|S028|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/1994|08/19/1994|||APPR|
P850022|S001|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK(R) BONE GROWTH STIMULATOR|LOF|OR|Special (Immediate Track)|Other Report|N|09/16/1986|10/08/1986|||APPR|
P850022|S003|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK(R) BONE GROWTH STIMULATOR|LOF|OR|Special (Immediate Track)|Other Report|N|11/17/1986|12/16/1986|||APPR|
P850022|S004|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK(R) BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/04/1987|09/17/1987|||APPR|
P850022|S005|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK(R) BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/1989|02/24/1989|||APPR|
P850022|S006|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK(R) BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1989|12/13/1989|||APPR|
P850022|S007|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK(R) BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/1992|03/09/1994|||APPR|
P850022|S008|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK(R) BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/1992|08/06/1993|||APPR|
P850023|S001|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT|LMF|SU|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|08/12/1986|09/18/1986|||APPR|
P850023|S002|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Other Report|N|10/29/1986|01/29/1987|||APPR|
P850023|S003|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/1987|07/28/1987|||APPR|
P850023|S004|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1987|01/04/1988|||APPR|
P850023|S005|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/04/1987|05/17/1989|||APPR|
P850023|S006|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/1987|09/09/1988|||APPR|
P850023|S008|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/1988|03/09/1989|||APPR|
P850023|S009|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/1989|09/28/1990|||APPR|
P850023|S010|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/1991|11/16/1992|||APPR|
P850023|S011|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/1991|10/04/1991|||APPR|
P850023|S013|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|ABSORBABLE COLLAGEN HEMOSTAT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/22/1992|08/26/1992|||APPR|
P850023|S014|Datascope Corp.|14 PHILIPS PKWY.||MONTVALE|NJ|07645||Agent, absorbable hemostatic, collagen based|ABSORBABLE COLLAGEN HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/1994|12/22/1994|||APPR|
P850025|S001|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|NON-PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/1986|09/09/1986|||APPR|
P850025|S002|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|NON-PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1986|07/31/1987|||APPR|
P850025|S003|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|NON-PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Other Report|N|05/11/1987|10/07/1987|||APPR|
P850025|S004|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|NON-PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1987|05/02/1988|||APPR|
P850025|S005|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|NON-PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1988|07/29/1988|||APPR|
P850025|S006|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|NON-PRESERVED SALINE SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1988|08/08/1988|||APPR|
P850025|S007|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|NON-PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1989|08/10/1989|||APPR|
P850026|S001|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|HYDROGEN PEROXIDE DISINFECTION SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1987|09/21/1987|||APPR|
P850026|S002|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|HYDROGEN PEROXIDE DISINFECTION SOLUTION|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|05/21/1987|09/14/1987|||APPR|
P850026|S003|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|HYDROGEN PEROXIDE DISINFECTION SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/20/1988|01/12/1989|||APPR|
P850026|S004|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|HYDROGEN PEROXIDE DISINFECTION SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1988|07/29/1988|||APPR|
P850026|S005|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|HYDROGEN PEROXIDE DISINFECTION SOLUTION|LPN|OP|Normal 180 Day Track|Other Report|N|03/20/1989|09/26/1989|||APPR|
P850026|S006|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|HYDROGEN PEROXIDE DISINFECTION SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|11/07/1989|||APPR|
P850027|S001|TELECTRONICS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|TELECTRONICS PASAR MODEL 4171 PG|LWW|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1987|03/27/1987|||APPR|
P850027|S002|TELECTRONICS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|TELECTRONICS PASAR MODEL 4171 PG|LWW|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/1989|04/18/1989|||APPR|
P850027|S003|TELECTRONICS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|TELECTRONICS PASAR MODEL 4171 PG|LWW|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/1989|03/22/1990|||APPR|
P850027|S005|TELECTRONICS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|TELECTRONICS PASAR MODEL 4171 PG|LWW|AN|Normal 180 Day Track|Other Report|N|01/16/1990|02/02/1990|||APPR|
P850027|S006|TELECTRONICS, INC.|7400 SOUTH TUCSON WAY||ENGLEWOOD|CO|80112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|TELECTRONICS PASAR MODEL 4171 PG|LWW|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1990|05/09/1990|||APPR|
P850033|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, extended wear|SCANLENS (SCAFILCON A CONTACT LENS)|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/1988|07/28/1988|||APPR|
P850035|S002|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Other Report|N|01/15/1988|03/17/1988|||APPR|
P850035|S003|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/1988|04/21/1988|||APPR|
P850035|S004|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1988|04/21/1988|||APPR|
P850035|S005|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/1988|09/22/1988|||APPR|
P850035|S006|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/1988|10/28/1988|||APPR|
P850035|S007|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1988|01/13/1989|||APPR|
P850035|S008|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/1990|08/31/1990|||APPR|
P850035|S010|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1990|11/15/1993|||APPR|
P850035|S012|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/1991|08/12/1991|||APPR|
P850035|S013|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF(R) IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/1992|03/09/1994|||APPR|
P850035|S016|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF(R) IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/1994|04/06/1995|||APPR|
P850035|S017|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF(R) IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/22/1994|12/21/1994|||APPR|
P850036|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L SENSITIVE EYES(TM) SALINE/CLEANING  SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1993|11/07/1994|||APPR|
P850036|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L SENSITIVE EYES(TM) SALINE/CLEANING  SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1994|02/23/1995|||APPR|
P850037|S001|AKORN, INC.|3001 19TH ST.||METAIRIE|LA|70002||Accessories, soft lens products|SODIUM CHLORIDE TABLETS, USP|LPN|OP|||N|04/01/1986|06/09/1986|||APPR|
P850038|S001|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/1987|12/14/1987|||APPR|
P850038|S003|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1987|04/06/1988|||APPR|
P850038|S005|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/1989|03/27/1989|||APPR|
P850038|S006|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1989|05/31/1989|||APPR|
P850038|S007|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/1989|12/27/1989|||APPR|
P850038|S008|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/1989|01/18/1990|||APPR|
P850038|S009|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/1989|11/22/1989|||APPR|
P850038|S010|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/1990|03/29/1990|||APPR|
P850038|S011|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1990|05/10/1990|||APPR|
P850038|S012|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/1990|08/28/1990|||APPR|
P850038|S013|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/1990|07/23/1990|||APPR|
P850038|S014|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/1990|10/31/1990|||APPR|
P850038|S015|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/1990|02/05/1991|||APPR|
P850038|S016|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1991|08/15/1991|||APPR|
P850038|S017|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1992|02/18/1992|||APPR|
P850038|S018|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON C) RGP GRAY TINT|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|06/12/1992|||APPR|
P850038|S019|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/1992|03/30/1992|||APPR|
P850038|S020|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/1992|11/25/1992|||APPR|
P850038|S021|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/1993|04/14/1993|||APPR|
P850038|S022|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/04/1994|||APPR|
P850038|S023|PARAGON OPTICAL CO.|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/04/1994|||APPR|
P850039|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, daily wear|B&L 58(TM) (ETAFILCONA) CONTACT LENS|LPL|OP|||N|03/18/1986|07/31/1986|||APPR|
P850039|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, daily wear|B&L 58(TM) (ETAFILCONA) CONTACT LENS|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1987|05/08/1987|||APPR|
P850039|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, daily wear|B&L 58(TM) (ETAFILCONA) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/1987|09/11/1990|||APPR|
P850039|S004|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, daily wear|B&L 58(TM) (ETAFILCONA) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/18/1988|02/21/1989|||APPR|
P850039|S005|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, daily wear|B&L 58(TM) (ETAFILCONA) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|02/01/1990|||APPR|
P850039|S006|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, daily wear|B&L 58(TM) (ETAFILCONA) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/1991|10/30/1991|||APPR|
P850043|S001|THOMSON-CGR MEDICAL CORP.|10150 OLD COLUMBIA RD.||COLUMBIA|MD|21046||System, nuclear magnetic resonance imaging|MAGNISCAN 5000 MRI SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/1987|12/30/1987|||APPR|
P850043|S002|THOMSON-CGR MEDICAL CORP.|10150 OLD COLUMBIA RD.||COLUMBIA|MD|21046||System, nuclear magnetic resonance imaging|MAGNISCAN 5000 MRI SYSTEM|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1987|12/29/1987|||APPR|
P850044|S001|SORIN BIOMEDICA, FIAT, USA, INC.|FIAT USA INC.|375 PARK AVE.|NY|NY|10152||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AB-CORE K HEPATITIS B CORE ANTIGEN 125I|LOM|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/1986|08/26/1986|||APPR|
P850044|S002|SORIN BIOMEDICA, FIAT, USA, INC.|FIAT USA INC.|375 PARK AVE.|NY|NY|10152||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AB-CORE K HEPATITIS B CORE ANTIGEN 125I|LOM|MI|Normal 180 Day Track|Other Report|N|08/01/1986|10/31/1986|||APPR|
P850044|S003|SORIN BIOMEDICA, FIAT, USA, INC.|FIAT USA INC.|375 PARK AVE.|NY|NY|10152||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AB-CORE K HEPATITIS B CORE ANTIGEN 125I|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1986|02/17/1987|||APPR|
P850045|S001|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/1986|06/27/1986|||APPR|
P850045|S002|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/1986|08/27/1987|||APPR|
P850045|S003|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Other Report|N|01/23/1987|09/21/1987|||APPR|
P850045|S004|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1987|09/28/1987|||APPR|
P850045|S005|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/1987|10/20/1987|||APPR|
P850045|S006|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1987|12/30/1987|||APPR|
P850045|S008|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/1987|02/23/1988|||APPR|
P850045|S010|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1988|06/29/1988|||APPR|
P850045|S011|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Other Report|N|06/28/1988|05/02/1989|||APPR|
P850045|S013|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/1988|10/28/1988|||APPR|
P850045|S014|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1989|06/26/1989|||APPR|
P850045|S015|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/1992|05/27/1994|||APPR|
P850045|S016|BLAIREX LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 2127|COLUMBUS|IN|47201||Accessories, soft lens products|BLAIREX STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/1992|05/27/1994|||APPR|
P850047|S001|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|THIMEROSAL PRESERVED SALINE SOLUTION|LPN|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/1987|12/29/1987|||APPR|
P850047|S002|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|THIMEROSAL PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1988|07/29/1988|||APPR|
P850047|S003|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|THIMEROSAL PRESERVED SALINE SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1988|08/08/1988|||APPR|
P850047|S004|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|THIMEROSAL PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|11/07/1989|||APPR|
P850048|S001|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/1987|07/23/1987|||APPR|
P850048|S002|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/1987|07/10/1987|||APPR|
P850048|S003|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/1989|08/21/1989|||APPR|
P850048|S004|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/1989|08/10/1989|||APPR|
P850048|S005|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/1990|07/10/1990|||APPR|
P850048|S006|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1990|11/05/1990|||APPR|
P850048|S007|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|HYBRITECH(R) STRATUS(R) PSA ASSAY FLOUROMETRIC|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1991|05/21/1992|||APPR|
P850048|S008|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1991|03/24/1992|||APPR|
P850048|S009|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC|LTJ|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/29/1992|08/25/1994|94M-0327|10/14/1994|APPR|
P850049|S001|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|COOK BIRD'S NEST VENA CAVA FILTER|DTK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/1991|12/08/1992|||APPR|
P850049|S002|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|COOK BIRD'S NEST VENA CAVA FILTER|DTK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/09/1991|05/02/1991|||APPR|
P850049|S003|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|COOK BIRD'S NEST VENA CAVA FILTER|DTK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/22/1993|09/23/1993|||APPR|
P850049|S004|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|COOK BIRD'S NEST VENA CAVA FILTER|DTK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/1994|08/09/1994|||APPR|
P850051|S001|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/1986|03/02/1988|||APPR|
P850051|S002|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/1986|01/09/1987|||APPR|
P850051|S003|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/1986|02/03/1987|||APPR|
P850051|S004|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/1986|09/04/1986|||APPR|
P850051|S005|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/1986|09/10/1986|||APPR|
P850051|S006|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1986|09/10/1986|||APPR|
P850051|S007|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Other Report|N|01/30/1987|06/26/1987|||APPR|
P850051|S008|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/1987|06/26/1987|||APPR|
P850051|S010|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Other Report|N|06/29/1987|07/28/1987|||APPR|
P850051|S011|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/11/1987|11/18/1987|||APPR|
P850051|S012|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1987|07/15/1988|||APPR|
P850051|S013|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/17/1988|05/09/1988|||APPR|
P850051|S014|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/1988|04/21/1988|||APPR|
P850051|S015|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1988|07/12/1988|||APPR|
P850051|S016|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/1988|08/11/1988|||APPR|
P850051|S017|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/1988|11/23/1988|||APPR|
P850051|S020|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/20/1989|07/31/1989|||APPR|
P850051|S021|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX MODELS 8400, 8402, 8403|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1989|09/26/1989|||APPR|
P850051|S022|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|LEGEND MODELS 8416/8417/8418,ST MODELS 8406/8407|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1989|10/18/1989|||APPR|
P850051|S023|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|UNIPOLAR IS-1 CONNECTOR RECEPTACLE MODEL|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1989|03/06/1990|||APPR|
P850051|S024|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|UNIPOLAR IS-1 CONNECTOR RECEPTACLE MODEL|LWO|CV|Normal 180 Day Track|Other Report|N|11/30/1989|01/18/1990|||APPR|
P850051|S025|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC MICRO MINIX PULSE GENERATOR MODEL 8360|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/29/1990|10/30/1990|||APPR|
P850051|S026|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|LEGEND/LEGEND ST PULSE GENERATORS : NEW IC|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1990|07/17/1990|||APPR|
P850051|S027|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTRIVITRAX & II MODEL 8400 & 8412 & LEGEND 8416|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/1990|12/12/1990|||APPR|
P850051|S028|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|LEGEND PULSE GENERATORS & MICRO MINIX|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/1990|02/06/1991|||APPR|
P850051|S029|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|LEGEND PULSE GENERATORS & MICRO MINIX|LWO|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1990|12/27/1990|||APPR|
P850051|S030|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX,ATRIVITRAX II, LEGEND, & MICRO MINIX|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/1991|07/26/1991|||APPR|
P850051|S031|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX PACING SYSTEM|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/1991|05/08/1991|||APPR|
P850051|S032|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|LEGEND II MODELS 8424,8426,8427 AND 8430 PULSE G.|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/1991|11/25/1991|||APPR|
P850051|S033|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MODELS 8416 AND 8418 LEGEND PACEMAKERS|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/1991|10/25/1991|||APPR|
P850051|S034|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MODELS 8416,17,18,19 LEGEND PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1991|12/18/1991|||APPR|
P850051|S035|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC LEGEND,LEGEND II  & TRIUMPH VR PULSE GEN|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/26/1992|04/10/1992|||APPR|
P850051|S036|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC LEGEND II,MICRO MINIX MODIFICATIONS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/1992|11/05/1992|||APPR|
P850051|S037|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC LEGEND II,MICRO MINIX MODIFICATIONS|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/09/1992|04/21/1993|||APPR|
P850051|S038|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC LEGEND II,MICRO MINIX MODIFICATIONS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/16/1993|05/18/1993|||APPR|
P850051|S039|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC MODEL 8360 MICRO MINIX|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/1993|07/02/1993|||APPR|
P850051|S040|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC ACTIVITRAX PULSE GENERATOR|LWO|CV|Normal 180 Day Track|Other Report|N|06/14/1993|01/26/1994|||APPR|
P850051|S041|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/1994|01/31/1995|||APPR|
P850051|S043|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1994|10/06/1994|||APPR|
P850051|S044|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/1994|09/06/1994|||APPR|
P850051|S045|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1994|03/01/1995|||APPR|
P850051|S046|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/1994|01/05/1995|||APPR|
P850051|S048|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/1994|01/05/1995|||APPR|
P850051|S049|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/1994|01/05/1995|||APPR|
P850053|S001|MENTOR CORP.|201 MENTOR DRIVE||SANTA BARBARA|CA|93111||Implant, dermal, for aesthetic use|FIBREL|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/1988|07/18/1988|||APPR|
P850053|S002|MENTOR CORP.|201 MENTOR DRIVE||SANTA BARBARA|CA|93111||Implant, dermal, for aesthetic use|FIBREL|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/18/1988|06/27/1990|||APPR|
P850053|S003|MENTOR CORP.|201 MENTOR DRIVE||SANTA BARBARA|CA|93111||Implant, dermal, for aesthetic use|FIBREL|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/11/1989|02/09/1989|||APPR|
P850053|S004|MENTOR CORP.|201 MENTOR DRIVE||SANTA BARBARA|CA|93111||Implant, dermal, for aesthetic use|FIBREL|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/10/1991|08/14/1991|||APPR|
P850055|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|MIRAFLOW EXTRA STRENGTH CLEANER|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/1987|07/23/1987|||APPR|
P850055|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|MIRAFLOW EXTRA STRENGTH CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/1988|05/05/1988|||APPR|
P850055|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|MIRAFLOW EXTRA STRENGTH CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/1989|09/14/1989|||APPR|
P850055|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|MIRAFLOW EXTRA STRENGTH CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/1990|05/22/1990|||APPR|
P850055|S006|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|MIRAFLOW(R) EXTRA STRENGTH DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/1990|06/03/1991|||APPR|
P850055|S009|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|MIRAFLOW(R) EXTRA STRENGTH DAILY CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1990|03/18/1991|||APPR|
P850057|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CUSTOMEYES(TM) 45L&55L (BUFILCON A)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/1986|05/08/1987|87M-0191|06/29/1987|APPR|
P850057|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CUSTOMEYES(TM) 45L&55L (BUFILCON A)|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/1986|01/29/1987|||APPR|
P850057|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CUSTOMEYES(TM) 45L&55L (BUFILCON A)|LPM|OP|Normal 180 Day Track|Other Report|N|12/23/1986|02/17/1987|||APPR|
P850057|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CUSTOMEYES(TM) 45L&55L (BUFILCON A)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/23/1990|||APPR|
P850058|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CUSTOMEYES 70L & 79L (LIDOFILCON A&B)|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/1986|01/29/1987|||APPR|
P850058|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CUSTOMEYES 70L & 79L (LIDOFILCON A&B)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/23/1990|||APPR|
P850059|S001|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Other Report|N|02/20/1987|10/17/1989|||APPR|
P850059|S005|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/14/1987|06/13/1989|||APPR|
P850059|S006|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/1988|05/09/1988|||APPR|
P850059|S007|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|CELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/1988|03/02/1989|||APPR|
P850059|S008|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/22/1988|10/03/1988|||APPR|
P850059|S009|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1988|04/11/1990|||APPR|
P850059|S010|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1988|04/11/1990|||APPR|
P850059|S011|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/28/1988|04/11/1990|||APPR|
P850059|S012|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1989|03/19/1990|||APPR|
P850059|S013|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1989|12/11/1989|||APPR|
P850059|S014|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|KELMAN(TM) OMNIFIT II MODEL 2100|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1989|09/28/1990|||APPR|
P850061|S001|ZIMMER, INC.|PO BOX 708||WARSAW|IN|46580|0708|PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED|BIAS(R) FIBER METAL TOTAL HIP SYSTEM|LPH|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/1989|03/29/1989|||APPR|
P850061|S002|ZIMMER, INC.|PO BOX 708||WARSAW|IN|46580|0708|PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED|BIAS(R) FIBER METAL TOTAL HIP SYSTEM|LPH|OR|Normal 180 Day Track|Other Report|N|08/13/1990|03/08/1991|||APPR|
P850062|S001|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|HEPATITIS DELTA SEROLOGICAL REAGENTS|ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)|LQI|MI|||N|08/30/1985|07/29/1986|||APPR|
P850063|S001|SORIN GROUP USA INC.|14401 WEST 65TH WAY||ARVADA|CO|80004||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|MICRO YAG ND:YAG LASER SYSTEM|LOI|OP|||N|05/19/1986|06/17/1986|||APPR|
P850064|S001|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Other Report|N|09/19/1988|02/02/1989|||APPR|
P850064|S002|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/1989|03/15/1989|||APPR|
P850064|S003|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|01/26/1990|||APPR|
P850064|S005|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/1990|03/17/1994|||APPR|
P850064|S006|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1991|01/09/1992|||APPR|
P850064|S009|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY JET VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/1992|04/02/1993|||APPR|
P850064|S010|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY JET VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1994|11/18/1994|||APPR|
P850065|S001|STERICON, INC.|19742 MACARTHUR BLVD.|SUITE 235|IRVINE|CA|92715||Accessories, soft lens products|CRYSTALENS SALINE SPRAY|LPN|OP|||N|02/25/1986|06/27/1986|||APPR|
P850065|S002|STERICON, INC.|19742 MACARTHUR BLVD.|SUITE 235|IRVINE|CA|92715||Accessories, soft lens products|CRYSTALENS SALINE SPRAY|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/1986|09/23/1986|||APPR|
P850065|S006|STERICON, INC.|19742 MACARTHUR BLVD.|SUITE 235|IRVINE|CA|92715||Accessories, soft lens products|CRYSTALENS SALINE SPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/1987|09/09/1987|||APPR|
P850065|S007|STERICON, INC.|19742 MACARTHUR BLVD.|SUITE 235|IRVINE|CA|92715||Accessories, soft lens products|CRYSTALENS SALINE SPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/1987|09/30/1987|||APPR|
P850065|S008|STERICON, INC.|19742 MACARTHUR BLVD.|SUITE 235|IRVINE|CA|92715||Accessories, soft lens products|CRYSTALENS SALINE SPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/1987|08/17/1987|||APPR|
P850065|S009|STERICON, INC.|19742 MACARTHUR BLVD.|SUITE 235|IRVINE|CA|92715||Accessories, soft lens products|CRYSTALENS SALINE SPRAY|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/13/1987|02/23/1988|||APPR|
P850065|S012|STERICON, INC.|19742 MACARTHUR BLVD.|SUITE 235|IRVINE|CA|92715||Accessories, soft lens products|CRYSTALENS SALINE SPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/1988|12/11/1989|||APPR|
P850065|S013|STERICON, INC.|19742 MACARTHUR BLVD.|SUITE 235|IRVINE|CA|92715||Accessories, soft lens products|CRYSTALENS SALINE SPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/1990|10/24/1990|||APPR|
P850068|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lens, contact (polymethylmethacrylate)|SILSOFT (ELASTOFILCON A) CONTACT LENSES|HPX|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1987|05/08/1987|||APPR|
P850068|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lens, contact (polymethylmethacrylate)|SILSOFT (ELASTOFILCON A) CONTACT LENSES|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/1987|09/11/1990|||APPR|
P850068|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lens, contact (polymethylmethacrylate)|SILSOFT (ELASTOFILCON A) CONTACT LENSES|HPX|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/1988|02/10/1989|||APPR|
P850068|S004|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lens, contact (polymethylmethacrylate)|SILSOFT (ELASTOFILCON A) CONTACT LENSES|HPX|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/18/1989|01/31/1990|||APPR|
P850068|S005|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lens, contact (polymethylmethacrylate)|SILSOFT (ELASTOFILCON A) CONTACT LENSES|HPX|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|11/15/1991|||APPR|
P850068|S006|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lens, contact (polymethylmethacrylate)|SILSOFT (ELASTOFILCON A) CONTACT LENSES|HPX|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|11/15/1991|||APPR|
P850068|S007|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lens, contact (polymethylmethacrylate)|SILSOFT (ELASTOFILCON A) CONTACT LENSES|HPX|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/1991|10/30/1991|||APPR|
P850069|S001|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/1988|07/14/1988|||APPR|
P850069|S002|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1988|09/07/1988|||APPR|
P850069|S003|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/1988|01/13/1989|||APPR|
P850069|S004|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/1989|11/22/1989|||APPR|
P850069|S005|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/1989|03/08/1990|||APPR|
P850069|S006|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/1989|12/31/1992|93M-0018|05/03/1993|APPR|
P850069|S007|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1989|10/17/1990|||APPR|
P850069|S008|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1991|01/28/1992|||APPR|
P850069|S009|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track||N|09/13/1991|03/13/1992|||APPR|
P850069|S010|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1994|05/19/1994|||APPR|
P850069|S011|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|LIGAMENTS AND TENDONS, SYNTHETIC|KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE|LML|PM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/1994|11/28/1994|||APPR|
P850070|S002|AUTOMATIC LIQUID PACKAGING, INC.|2200 W. LAKE SHORE DR.||WOODSTOCK|IL|60098||Accessories, soft lens products|STERICON SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1987|12/29/1987|||APPR|
P850070|S003|AUTOMATIC LIQUID PACKAGING, INC.|2200 W. LAKE SHORE DR.||WOODSTOCK|IL|60098||Accessories, soft lens products|STERICON SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/1989|09/18/1989|||APPR|
P850070|S004|AUTOMATIC LIQUID PACKAGING, INC.|2200 W. LAKE SHORE DR.||WOODSTOCK|IL|60098||Accessories, soft lens products|4 OZ. STERILE UNPRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1989|03/15/1990|||APPR|
P850070|S005|AUTOMATIC LIQUID PACKAGING, INC.|2200 W. LAKE SHORE DR.||WOODSTOCK|IL|60098||Accessories, soft lens products|STERILE UNPRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/1990|06/22/1990|||APPR|
P850070|S006|AUTOMATIC LIQUID PACKAGING, INC.|2200 W. LAKE SHORE DR.||WOODSTOCK|IL|60098||Accessories, soft lens products|STERILE UNPRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/1990|11/05/1990|||APPR|
P850072|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1986|04/09/1987|||APPR|
P850072|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS|LPM|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/12/1987|02/24/1988|88M-0082|03/30/1988|APPR|
P850072|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1989|08/28/1989|||APPR|
P850072|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|12/28/1989|||APPR|
P850072|S005|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|08/29/1990|||APPR|
P850072|S006|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|DURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/1989|03/05/1990|||APPR|
P850072|S007|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|DURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/1989|03/09/1990|||APPR|
P850074|S001|W.L. GORE & ASSOCIATES,INC|1500 NORTH FOURTH ST.|DOCK 3 P.O. BOX 800|FLAGSTAFF|AZ|86002||PROSTHESIS, LIGAMENT, PTFE|GORE-TEX EXPANDED PTFE PROSTHETIC LIGAMENT|LWA|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1986|01/16/1987|||APPR|
P850074|S003|W.L. GORE & ASSOCIATES,INC|1500 NORTH FOURTH ST.|DOCK 3 P.O. BOX 800|FLAGSTAFF|AZ|86002||PROSTHESIS, LIGAMENT, PTFE|GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS|LWA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/1987|06/30/1987|||APPR|
P850074|S004|W.L. GORE & ASSOCIATES,INC|1500 NORTH FOURTH ST.|DOCK 3 P.O. BOX 800|FLAGSTAFF|AZ|86002||PROSTHESIS, LIGAMENT, PTFE|GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS|LWA|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/11/1988|12/12/1988|||APPR|
P850074|S006|W.L. GORE & ASSOCIATES,INC|1500 NORTH FOURTH ST.|DOCK 3 P.O. BOX 800|FLAGSTAFF|AZ|86002||PROSTHESIS, LIGAMENT, PTFE|GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS|LWA|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/1989|08/03/1989|||APPR|
P850074|S008|W.L. GORE & ASSOCIATES,INC|1500 NORTH FOURTH ST.|DOCK 3 P.O. BOX 800|FLAGSTAFF|AZ|86002||PROSTHESIS, LIGAMENT, PTFE|GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS|LWA|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/1991|03/03/1993|||APPR|
P850075|S001|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Normal 180 Day Track|Other Report|N|01/16/1987|09/09/1987|||APPR|
P850075|S002|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1987|09/28/1987|||APPR|
P850075|S003|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/1987|02/08/1988|||APPR|
P850075|S004|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1988|07/29/1988|||APPR|
P850075|S005|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1988|08/08/1988|||APPR|
P850075|S006|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/06/1989|04/12/1990|||APPR|
P850075|S007|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|11/07/1989|||APPR|
P850075|S008|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/1990|10/31/1990|||APPR|
P850076|S001|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1987|09/21/1987|||APPR|
P850076|S002|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED DAILY CLEANER|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/1987|02/10/1988|||APPR|
P850076|S003|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1988|07/19/1988|||APPR|
P850076|S005|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED DAILY CLEANER|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1988|08/08/1988|||APPR|
P850076|S006|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED DAILY CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1988|11/10/1988|||APPR|
P850076|S007|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED DAILY CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/06/1989|10/16/1989|||APPR|
P850076|S008|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1989|11/07/1989|||APPR|
P850077|S001|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|||N|10/02/1985|06/25/1986|86M-0310|08/07/1986|APPR|
P850077|S002|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/1986|09/29/1986|||APPR|
P850077|S004|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|12/11/1986|02/17/1987|||APPR|
P850077|S005|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/02/1987|02/10/1988|||APPR|
P850077|S006|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/1988|07/21/1988|||APPR|
P850077|S008|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/1988|10/28/1988|||APPR|
P850077|S010|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/1988|09/06/1989|||APPR|
P850077|S011|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|11/30/1989|||APPR|
P850077|S012|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/1989|02/28/1990|||APPR|
P850077|S013|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/1990|01/14/1991|||APPR|
P850077|S014|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/1991|02/18/1992|||APPR|
P850077|S015|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|REVOLUTION(TM) (METHAFILCON A) HYDROPHILIC LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/1991|08/27/1991|||APPR|
P850077|S017|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SEDUCTIONS(TM) (METHAFILCON A) HYDROPHILIC LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/1992|02/10/1993|||APPR|
P850077|S018|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|REVOLUTIONS (TM) ALT. MANU. SITE CONTACTS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/1992|05/05/1995|||APPR|
P850077|S019|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/1994|04/28/1995|||APPR|
P850077|S020|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/27/1994|05/05/1995|||APPR|
P850078|S001|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) CONTACT LNS|LPL|OP|||N|10/02/1985|06/25/1986|86M-0304|08/07/1986|APPR|
P850078|S002|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1986|09/29/1986|||APPR|
P850078|S003|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1987|09/28/1987|||APPR|
P850078|S004|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1987|09/28/1987|||APPR|
P850078|S006|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1987|12/01/1987|||APPR|
P850078|S007|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/1987|09/30/1987|||APPR|
P850078|S008|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/1987|08/10/1987|||APPR|
P850078|S010|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/1988|03/14/1989|||APPR|
P850078|S012|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|12/11/1989|||APPR|
P850078|S013|KONTUR KONTACT LENS CO., INC.|642 ALFRED NOBEL DR.||HERCULES|CA|94547||Lenses, soft contact, daily wear|KONTUR SOFT (METHAFILCON A) LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/18/1989|01/03/1990|||APPR|
P850079|S001|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|||N|10/02/1985|06/25/1986|86M-0306|08/07/1986|APPR|
P850079|S002|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/1986|11/12/1986|||APPR|
P850079|S003|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/1986|11/12/1986|||APPR|
P850079|S004|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/1986|09/22/1986|||APPR|
P850079|S005|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/12/1986|11/18/1986|||APPR|
P850079|S007|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/1987|06/22/1987|||APPR|
P850079|S008|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/1987|05/10/1988|||APPR|
P850079|S009|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Other Report|N|11/12/1987|03/15/1988|||APPR|
P850079|S010|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/1988|05/02/1989|||APPR|
P850079|S011|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/1988|11/14/1990|||APPR|
P850079|S012|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1988|09/19/1989|||APPR|
P850079|S013|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/06/1989|09/06/1989|||APPR|
P850079|S014|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/1989|12/11/1989|||APPR|
P850079|S015|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/1990|12/10/1990|||APPR|
P850079|S016|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/1990|08/17/1990|||APPR|
P850079|S017|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON B) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/07/1990|03/11/1993|||APPR|
P850079|S018|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON B) VISIBILITY TINT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/10/1990|04/25/1991|||APPR|
P850079|S019|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/15/1991|10/23/1991|||APPR|
P850079|S020|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/1991|08/06/1992|||APPR|
P850079|S021|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/11/1991|03/11/1993|||APPR|
P850079|S024|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT KERATOCONUS METHAFILCON B|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/1993|04/06/1993|||APPR|
P850079|S025|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT KERATOCONUS METHAFILCON B|LPL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/04/1994|06/24/1994|||APPR|
P850083|S001|CARL ZEISS, INC.|ONE ZEISS DR.||THORNWOOD|NY|10594||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|VISULAS ND:YAG LASER|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/15/1986|03/10/1987|||APPR|
P850083|S003|CARL ZEISS, INC.|ONE ZEISS DR.||THORNWOOD|NY|10594||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|VISULAS ND:YAG LASER|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/08/1986|12/04/1986|||APPR|
P850083|S004|CARL ZEISS, INC.|ONE ZEISS DR.||THORNWOOD|NY|10594||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|VISULAS ND:YAG LASER|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/14/1986|03/31/1987|87M-0138|05/13/1987|APPR|
P850083|S005|CARL ZEISS, INC.|ONE ZEISS DR.||THORNWOOD|NY|10594||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|VISULAS ND:YAG LASER|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/12/1987|09/30/1987|||APPR|
P850083|S006|CARL ZEISS, INC.|ONE ZEISS DR.||THORNWOOD|NY|10594||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|VISULAS ND:YAG LASER|LOI|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/14/1987|10/05/1987|||APPR|
P850083|S007|CARL ZEISS, INC.|ONE ZEISS DR.||THORNWOOD|NY|10594||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|VISULAS ND:YAG LASER|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/1988|07/15/1988|||APPR|
P850083|S008|CARL ZEISS, INC.|ONE ZEISS DR.||THORNWOOD|NY|10594||Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary|VISULAS ND:YAG LASER|LOI|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/1988|08/02/1989|||APPR|
P850086|S001|SANDOZ PHARMACEUTICALS CORP.|RTE 10||E. HANOVER|NJ|07936||CYCLOSPORINE RADIOIMMUNOASSAY|SANDIMMUNE(R) RADIOIMMUNOASSAY KIT|LTB|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/1990|12/17/1991|||APPR|Approval for a change in the polyclonal antibody to a monoclonal specific and a monoclonal non-specific antibody assay.
P850087|S001|LITTON DATAMEDIX|RTE ONE||SHARON|MA|02067||MONITOR, CARBON-DIOXIDE, CUTANEOUS|LITTON TRANSCUTANEOUS CO2 SYSTEM|LKD|AN|Normal 180 Day Track|Other Report|N|09/12/1986|11/14/1986|||APPR|
P850088|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|OXYSEPT SYSTEM|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1987|05/08/1987|||APPR|
P850088|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|OXYSEPT SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/1987|02/08/1988|||APPR|
P850088|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|OXYSEPT SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
P850088|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|OXYSEPT SYSTEM|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1988|09/27/1989|||APPR|
P850088|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|OXYSEPT SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/1989|05/01/1990|||APPR|
P850088|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|OXYSEPT SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
P850088|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|OXYSEPT SYSTEM|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/1989|11/20/1989|||APPR|
P850088|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS OXYSEPT 2 NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1989|02/16/1990|||APPR|
P850088|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS OXYSEPT 2 NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1989|05/08/1990|||APPR|
P850088|S011|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS OXYSEPT 2 NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/1989|12/19/1989|||APPR|
P850088|S012|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS OXYSEPT 2 NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/1989|09/18/1990|||APPR|
P850088|S013|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS OXYSEPT 2 NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/11/1989|01/16/1990|||APPR|
P850088|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS OXYSEPT 2 NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/1989|01/31/1990|||APPR|
P850088|S016|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(R) OXYSEPT(R) 1 DISINFECTING SOL. 2 NEUT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/1990|08/29/1990|||APPR|
P850088|S018|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(R) OXYSEPT(R) 1 DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/1990|07/05/1990|||APPR|
P850088|S019|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(R) OXYSEPT(R) 1 DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/1990|08/06/1991|||APPR|
P850088|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/1990|02/21/1992|||APPR|
P850088|S021|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1990|03/21/1991|||APPR|
P850088|S022|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/1991|03/23/1992|||APPR|
P850088|S024|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS PLUS(R) OXYSEPT(R) DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/1991|12/10/1991|||APPR|
P850088|S025|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) DISINFECTION SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/10/1992|05/05/1992|||APPR|
P850088|S026|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/1992|06/09/1993|||APPR|
P850088|S027|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1992|06/26/1992|||APPR|
P850088|S028|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/28/1992|03/09/1993|||APPR|
P850088|S029|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/28/1992|12/15/1993|||APPR|
P850088|S030|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1992|07/22/1994|||APPR|
P850088|S031|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1994|09/09/1994|||APPR|
P850089|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MODEL 5525 TRANSVENOUS ATRAIL & MODEL 5025 VENTRIC|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/1986|11/24/1986|||APPR|
P850089|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MODEL 5525 TRANSVENOUS ATRAIL & MODEL 5025 VENTRIC|DTB|CV|Normal 180 Day Track|Other Report|N|09/11/1986|09/25/1986|||APPR|
P850089|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/25/1986|10/07/1986|||APPR|
P850089|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/1987|02/26/1988|||APPR|
P850089|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/1987|12/03/1987|||APPR|
P850089|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/1988|11/03/1988|||APPR|
P850089|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1988|03/21/1988|||APPR|
P850089|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/1988|02/03/1989|||APPR|
P850089|S009|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/1988|12/19/1989|||APPR|
P850089|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/1989|04/20/1989|||APPR|
P850089|S011|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/1989|04/26/1989|||APPR|
P850089|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MODEL 5023M UNIPOLAR PACING LEAD|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/1990|08/28/1990|||APPR|
P850089|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MODEL 5024 TRANSVENOUS PACING LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/1990|09/27/1990|||APPR|
P850089|S014|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1990|09/27/1990|||APPR|
P850089|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1990|12/10/1990|||APPR|
P850089|S016|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1991|12/20/1991|||APPR|
P850089|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) MODEL 5023M,5024M PACING LEADS|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/29/1991|12/20/1991|||APPR|
P850089|S018|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) SP MODEL 5024M TRANSVENOUS PACING LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1991|03/05/1992|||APPR|
P850089|S020|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSURE(R)&CAPSURE(R) SP PACING LEADS|DTB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/1992|02/14/1992|||APPR|
P850089|S023|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CPI DEXATIP(TM) MODEL 4262 TRANSVENOUS PACING LEAD|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/1992|04/09/1992|||APPR|
P850089|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CPI MODEL4262 PACE LEAD ,MODIFY TECH MANUAL|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/15/1992|12/17/1992|||APPR|
P850089|S026|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R)SP LEADS|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/1992|03/17/1994|||APPR|
P850089|S027|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R)SP LEADS|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/1993|12/06/1993|||APPR|
P850089|S028|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R)SP LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/1993|03/04/1994|||APPR|
P850089|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R)SP LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/1994|12/08/1994|||APPR|
P850089|S030|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R)SP LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1994|01/31/1995|||APPR|
P850089|S031|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R)SP LEADS|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/1994|12/13/1994|||APPR|
P850093|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L THERMA-ZYME, FIZZICLEAN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/1987|07/24/1987|||APPR|
P850093|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L THERMA-ZYME, FIZZICLEAN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/1987|09/02/1988|||APPR|
P850093|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L THERMA-ZYME, FIZZICLEAN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/1987|09/19/1989|||APPR|
P850093|S004|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L THERMA-ZYME, FIZZICLEAN|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/1987|08/05/1987|||APPR|
P850093|S006|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L THERMA-ZYME, FIZZICLEAN|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1987|04/11/1988|||APPR|
P850093|S007|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L THERMA-ZYME, FIZZICLEAN|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1988|07/06/1988|||APPR|
P850093|S008|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L THERMA-ZYME, FIZZICLEAN|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/1989|08/11/1989|||APPR|
P850093|S009|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L THERMA-ZYME, FIZZICLEAN|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/1989|04/17/1990|||APPR|
P850093|S010|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|B&L RENU ENZYMATIC CLEANING TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1989|12/22/1993|||APPR|
P860002|S001|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1987|09/21/1987|||APPR|
P860002|S002|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/30/1987|01/27/1988|||APPR|
P860002|S005|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/1990|10/24/1990|||APPR|
P860002|S006|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|COBURN(R) POSTERIOR INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Other Report|N|10/23/1990|11/15/1990|||APPR|
P860002|S009|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|MODEL 120 POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/05/1992|08/06/1992|||APPR|
P860002|S010|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|MODEL 120 POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/1992|06/11/1992|||APPR|
P860002|S012|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1992|08/25/1994|||APPR|
P860002|S013|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/1992|08/09/1994|||APPR|
P860002|S014|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1993|06/27/1994|||APPR|
P860002|S015|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/1994|07/29/1994|||APPR|
P860003|S001|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1987|05/15/1987|||APPR|
P860003|S002|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1987|09/09/1987|||APPR|
P860003|S003|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/1987|11/06/1987|||APPR|
P860003|S004|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1987|11/06/1987|||APPR|
P860003|S005|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/1988|02/10/1988|||APPR|
P860003|S006|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1988|12/29/1988|||APPR|
P860003|S007|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/1988|06/17/1988|||APPR|
P860003|S008|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1988|06/30/1988|||APPR|
P860003|S009|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/1988|10/07/1988|||APPR|
P860003|S010|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/1988|12/28/1988|||APPR|
P860003|S011|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/1989|04/12/1989|||APPR|
P860003|S012|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/1989|02/23/1990|||APPR|
P860003|S013|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1989|12/22/1989|||APPR|
P860003|S014|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/1989|01/26/1990|||APPR|
P860003|S017|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/1990|12/13/1990|||APPR|
P860003|S018|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1990|02/13/1991|||APPR|
P860003|S019|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/1990|03/11/1991|||APPR|
P860003|S020|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/1991|12/07/1993|||APPR|
P860003|S021|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|TPS 102 PHOTOCEPTOR ACTIVATION CHAMBER|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/1991|06/19/1992|||APPR|
P860003|S022|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|TPS 101 PHOTOPHERESIS BLOOD TUBING SET|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1991|06/19/1992|||APPR|
P860003|S023|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHORESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/1993|01/26/1995|||APPR|
P860003|S024|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHORESIS SYSTEM|LNR|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/1994|05/18/1995|||APPR|
P860004|S001|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/1987|07/25/1991|91M-0321|09/11/1991|APPR|
P860004|S002|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYSTEM COMPONENTS AND MODELS NUMBERS|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/29/1988|05/24/1988|||APPR|
P860004|S003|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1988|11/17/1988|||APPR|
P860004|S004|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Other Report|N|06/03/1988|01/27/1989|||APPR|
P860004|S005|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/1988|01/11/1989|||APPR|
P860004|S006|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1988|02/02/1989|||APPR|
P860004|S007|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/1988|02/02/1989|||APPR|
P860004|S008|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1988|02/02/1989|||APPR|
P860004|S010|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/1989|06/26/1989|||APPR|
P860004|S011|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/1989|08/12/1992|||APPR|
P860004|S012|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1989|01/26/1990|||APPR|
P860004|S013|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/25/1989|03/11/1991|||APPR|
P860004|S014|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/28/1989|06/21/1990|||APPR|
P860004|S016|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC MODEL 8502 CATHETER ACCESS PORT|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/1990|11/06/1990|||APPR|
P860004|S017|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC(R) SYNCROMED(R) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1991|06/26/1991|||APPR|
P860004|S019|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MODEL 8810 SYNCHROMED PROGRAMMER|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/1991|09/24/1991|||APPR|
P860004|S020|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCROMED(R) INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/1991|10/28/1991|||APPR|
P860004|S022|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/1991|07/29/1996|||APPR|APPROVAL FOR (1) THE 10 CC SYNCHROMED IMPLANTABLE PROGRAMMABLE INFUSION PUMP, MODELS 8616-10 AND 8617-10 FOR USE IN THE PEDIATRIC AND ADULT POPULATION FOR THE INTRATHECAL DELIVERY OF LIORESAL INTRATHECAL (BACLOFEN INJECTION( FOR THE MANAGEMENT OF SEVERE SPASTICITY OF SPINAL AND CEREBRAL ORIGIN, AND (2) TO CHANGE THE INDICATIONS FOR THE INTRATHECAL DELIVERY OF LIORESAL INTRATHECAL (BACLOFEN INJECTION) FOR THE 18 CC RESERVOIR SYNCHROMED IMPLANTABLE, PROGRAMMABLE INFUSION PUMPS, MODELS 8616-18, 8617-18, 8617L-18, 8618-18, AND 8618L-18 TO INCLUDE SEVERE SPASTICITY OF CEREBRAL ORIGIN
P860004|S023|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCROMED INFUSION SYS. MODEL 8550 REFIL|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1991|03/24/1992|||APPR|
P860004|S024|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCROMED PROG.MODEL 8810 3.0 SOFTWARE|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/1992|06/30/1994|||APPR|
P860004|S026|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED LIORESAL (R) MODELS 8610H,8611H,8615|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/1992|01/26/1993|||APPR|
P860004|S027|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYS. MODEL 8551 REFILL KIT|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/1992|08/30/1994|||APPR|
P860004|S028|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED MODEL 8820 PROGRAMMER  (ALTERNATE)|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1992|08/04/1994|||APPR|
P860004|S029|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED MODEL 8502S ACCESS PORT|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1993|05/04/1994|||APPR|
P860004|S030|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED MODEL 8703W INTRASPINAL CATHETER|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1993|10/17/1994|||APPR|
P860004|S031|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PUMPS|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/07/1993|09/01/1994|||APPR|
P860004|S032|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/1994|08/30/1994|||APPR|
P860005|S001|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|INTERPORE PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FILLER|MBS|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/1993|03/17/1994|||APPR|
P860005|S002|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX|MBS|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/1993|11/17/1993|||APPR|
P860005|S003|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX|MBS|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1993|03/17/1994|||APPR|
P860005|S004|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX|MBS|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/1994|08/08/1994|||APPR|
P860007|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH TM IMPLANTABLE PACEMAKER PULSE|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/15/1989|05/22/1989|||APPR|
P860007|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH TM IMPLANTABLE PACEMAKER PULSE|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/1989|10/16/1989|||APPR|
P860007|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH TM IMPLANTABLE PACEMAKER PULSE|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1989|02/13/1990|||APPR|
P860007|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH TM IMPLANTABLE PACEMAKER PULSE|LWW|CV|Normal 180 Day Track|Other Report|N|09/15/1989|02/16/1990|||APPR|
P860007|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R) II IMPLANT. PACEMAKER PULSE GENERATOR|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1990|07/02/1991|||APPR|
P860007|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH & INTERTACH II PULSE GENERATORS|LWW|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/1991|11/19/1991|||APPR|
P860007|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH & INTERTACH II PULSE GENERATORS|LWW|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/1991|10/16/1991|||APPR|
P860007|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH & INTERTACH II PULSE GENERATORS|LWW|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/12/1992|03/03/1992|||APPR|
P860007|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R)II & RX2000(R) GRAPHICS PROGRAM MODULE|LWW|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1992|12/29/1992|||APPR|
P860007|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R)II MODELS 262-16/262-16R DISCON.TEST|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1992|01/11/1993|||APPR|
P860007|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R)II MODELS 262-16|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/15/1993|01/18/1995|||APPR|
P860007|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R)II MODELS 262-16|LWW|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/1993|08/04/1993|||APPR|
P860007|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R)II MODELS 262-16|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1993|05/17/1994|||APPR|
P860007|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R)II MODELS 262-16|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1993|05/17/1994|||APPR|
P860008|S001|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7|LPA|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/1987|03/17/1988|||APPR|
P860008|S002|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7|LPA|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1988|06/17/1988|||APPR|
P860008|S003|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7|LPA|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/05/1988|07/27/1988|||APPR|
P860008|S005|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7|LPA|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/1988|12/27/1988|||APPR|
P860008|S007|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7|LPA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/1989|04/18/1989|||APPR|
P860008|S008|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7|LPA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1989|12/06/1989|||APPR|
P860008|S009|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ESOPHAGEAL CARDIAC RECORDING & PACING CATHETER|LPA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/1990|03/25/1991|||APPR|
P860008|S010|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO OCTAPOLAR ESOPHAGEAL PACE & RECORD CATHETER|LPA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/20/1991|05/09/1991|||APPR|
P860008|S011|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS|LPA|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/20/1991|08/06/1992|||APPR|
P860009|S001|CONTAMAC LTD.|ORCHARD HOUSE|BEARWALDEN BUSINESS PARK|ESSEX||CB11-|4JX|Lenses, soft contact, daily wear|IDEL 67 CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/1987|10/13/1987|||APPR|
P860009|S002|CONTAMAC LTD.|ORCHARD HOUSE|BEARWALDEN BUSINESS PARK|ESSEX||CB11-|4JX|Lenses, soft contact, daily wear|IGEL 67 CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/06/1989|05/09/1989|||APPR|
P860010|S001|PALOMEX INSTRUMENTARIUM CORP.|HELSINKI, FINLAND||HELSINKI|TX|22222|2222|System, nuclear magnetic resonance imaging|ACUTSCAN MODEL 100 MRI SYSTEM|LNH|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/1987|04/22/1987|||APPR|
P860010|S002|PALOMEX INSTRUMENTARIUM CORP.|HELSINKI, FINLAND||HELSINKI|TX|22222|2222|System, nuclear magnetic resonance imaging|INSTRUMENTARIUM ULF MR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Other Report|N|04/20/1987|05/26/1987|||APPR|
P860010|S003|PALOMEX INSTRUMENTARIUM CORP.|HELSINKI, FINLAND||HELSINKI|TX|22222|2222|System, nuclear magnetic resonance imaging|INSTRUMENTARIUM ULF MR IMAGING SYSTEM|LNH|RA|Normal 180 Day Track|Other Report|N|01/20/1988|06/12/1988|||APPR|
P860012|S001|COLLAGEN CORP.|2500 FABER PLACE||PALO ALTO|CA|94303||BONE GRAFTING MATERIAL, ANIMAL SOURCE|ALVEOFORM TM BIOGRAFT|NPM|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/1988|12/13/1988|||APPR|
P860012|S002|COLLAGEN CORP.|2500 FABER PLACE||PALO ALTO|CA|94303||BONE GRAFTING MATERIAL, ANIMAL SOURCE|ALVEOFORM TM BIOGRAFT|NPM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1989|07/17/1990|||APPR|
P860012|S003|COLLAGEN CORP.|2500 FABER PLACE||PALO ALTO|CA|94303||BONE GRAFTING MATERIAL, ANIMAL SOURCE|ALVEOFORM TM BIOGRAFT|NPM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/1990|07/06/1990|||APPR|
P860012|S004|COLLAGEN CORP.|2500 FABER PLACE||PALO ALTO|CA|94303||BONE GRAFTING MATERIAL, ANIMAL SOURCE|ALVEOFORM TM BIOGRAFT|NPM|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/31/1990|09/12/1990|||APPR|
P860012|S005|COLLAGEN CORP.|2500 FABER PLACE||PALO ALTO|CA|94303||BONE GRAFTING MATERIAL, ANIMAL SOURCE|ALVEOFORM TM BIOGRAFT|NPM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/1994|03/21/1995|||APPR|
P860015|S001|ZEUS TECHNOLOGIES|P.O. Box 38||Raritan|NJ|08869||KIT, ASSAY, ESTROGEN RECEPTOR|FLUORO-CEP{R} ESTROGEN ASSAY REAGENT|LPJ|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/1991|04/21/1992|||APPR|
P860015|S002|ZEUS TECHNOLOGIES|P.O. Box 38||Raritan|NJ|08869||KIT, ASSAY, ESTROGEN RECEPTOR|FLUORO-CEP{R} ESTROGEN ASSAY REAGENT|LPJ|CH|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/1991|04/17/1992|||APPR|
P860019|S001|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/04/1987|03/13/1987|||APPR|
P860019|S002|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1987|10/07/1987|||APPR|
P860019|S003|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1987|11/10/1987|||APPR|
P860019|S004|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/1987|03/07/1988|||APPR|
P860019|S005|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1987|02/19/1988|||APPR|
P860019|S006|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/1987|05/18/1988|||APPR|
P860019|S007|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/16/1988|07/12/1988|||APPR|
P860019|S008|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/1988|05/18/1988|||APPR|
P860019|S009|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1988|07/18/1988|||APPR|
P860019|S010|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/1988|06/27/1988|||APPR|
P860019|S011|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/09/1988|06/27/1988|||APPR|
P860019|S012|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/1988|09/23/1988|||APPR|
P860019|S013|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/1988|08/31/1988|||APPR|
P860019|S014|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/1988|12/21/1988|||APPR|
P860019|S015|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1988|10/24/1988|||APPR|
P860019|S016|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1988|02/21/1989|||APPR|
P860019|S017|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1988|03/20/1989|||APPR|
P860019|S018|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Other Report|N|10/11/1988|02/24/1989|||APPR|
P860019|S019|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/1989|03/13/1989|||APPR|
P860019|S020|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/1989|12/04/1989|||APPR|
P860019|S021|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1989|12/01/1989|||APPR|
P860019|S022|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/1989|02/06/1990|||APPR|
P860019|S023|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/14/1989|02/06/1990|||APPR|
P860019|S024|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/1989|02/06/1990|||APPR|
P860019|S025|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/1990|07/20/1990|||APPR|
P860019|S026|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|0CIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/1990|09/12/1990|||APPR|
P860019|S027|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|0CIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/1990|12/27/1990|||APPR|
P860019|S028|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Other Report|N|03/16/1990|05/16/1990|||APPR|
P860019|S029|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/1990|07/10/1990|||APPR|
P860019|S030|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1990|01/25/1991|||APPR|
P860019|S031|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1990|03/20/1991|||APPR|
P860019|S032|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|08/16/1990|09/17/1990|||APPR|
P860019|S033|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/1990|12/19/1990|||APPR|
P860019|S034|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/1990|12/19/1990|||APPR|
P860019|S035|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1990|04/05/1991|||APPR|
P860019|S037|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM)|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/1990|12/13/1990|||APPR|
P860019|S038|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM)|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/31/1990|01/18/1991|||APPR|
P860019|S039|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/1991|04/03/1991|||APPR|
P860019|S040|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED TRAPPER(TM) EXCHANGE DEVICE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1991|11/19/1991|||APPR|
P860019|S041|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/1991|08/27/1991|||APPR|
P860019|S042|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED COBRA 10(TM) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1991|02/25/1992|||APPR|
P860019|S043|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|ACE(TM) AND LONG ACE(TM) MODELS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1991|08/29/1991|||APPR|
P860019|S044|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED ACE(TM) & EXPRESS(TM) PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/31/1991|11/19/1991|||APPR|
P860019|S045|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|STRONG SHADOW(TM) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1991|10/01/1992|||APPR|
P860019|S046|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PHANTOM(TM) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/1991|11/27/1991|||APPR|
P860019|S047|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED COBRA 14 CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1991|12/20/1991|||APPR|
P860019|S048|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED ACE(TM)&LONG ACE(TM)PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/1991|02/14/1992|||APPR|
P860019|S050|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|THE SHADOW(TM) P-14 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/19/1991|01/16/1992|||APPR|
P860019|S051|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA CATHETER (TRAPPER(TM))|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/09/1991|01/16/1992|||APPR|
P860019|S052|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED QUANTUM(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1991|07/21/1993|||APPR|
P860019|S053|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED ACE(TM) & LONG ACE(TM) PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/06/1992|01/28/1993|||APPR|
P860019|S054|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED LONG KING COBRA 30 & 40 PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/1992|02/05/1993|||APPR|
P860019|S055|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER  KING COBRA (TM)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|02/05/1993|||APPR|
P860019|S056|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER SHADOW(TM)P-14|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/14/1992|06/15/1993|||APPR|
P860019|S058|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) GRAFT ACE(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/1992|02/05/1993|||APPR|
P860019|S059|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/1992|04/28/1993|||APPR|
P860019|S060|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RALLY(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/1992|05/04/1993|||APPR|
P860019|S061|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) TRAPPER (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1992|05/04/1993|||APPR|
P860019|S063|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) ACE,LONG,GRAFT PTCA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/1992|04/28/1993|||APPR|
P860019|S064|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) ACE,LONG,EXPR. HYPO-SEAL(TM) ACCESSORY|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1992|04/28/1993|||APPR|
P860019|S065|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) ACE,LONGACE (TM)PTCA CATHETER CHANGES|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/1992|02/05/1993|||APPR|
P860019|S066|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER  NC COBRA 14|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1992|06/15/1993|||APPR|
P860019|S067|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER  NC COBRA 14|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/1992|06/14/1993|||APPR|
P860019|S068|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) NC RALLY(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/1993|07/01/1993|||APPR|
P860019|S069|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) LONG RALLY (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/1993|09/03/1993|||APPR|
P860019|S070|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/1993|02/11/1993|||APPR|
P860019|S071|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) SC COBRA(TM) 14 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1993|11/08/1993|||APPR|
P860019|S072|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/03/1993|01/04/1994|||APPR|
P860019|S073|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) ACE(TM) 1CM TIP PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/1991|09/13/1993|||APPR|
P860019|S074|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PIVOT (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/1993|07/29/1993|||APPR|
P860019|S075|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RALLY TURBO (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/1993|01/27/1994|||APPR|
P860019|S076|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RALLY TURBO (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1993|01/27/1994|||APPR|
P860019|S077|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1993|04/29/1994|||APPR|
P860019|S079|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) NC CRUISE(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1993|04/14/1994|||APPR|
P860019|S080|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1993|04/29/1994|||APPR|
P860019|S081|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) LONG CRUISE (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/1993|05/06/1994|||APPR|
P860019|S082|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) LONG CRUISE (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/1994|03/18/1994|||APPR|
P860019|S083|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) TRIO(TM) 14 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/13/1994|10/14/1994|||APPR|
P860019|S084|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) NC COBRA 18 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1994|11/15/1994|||APPR|
P860019|S085|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/12/1994|09/13/1994|||APPR|
P860019|S086|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/13/1994|08/25/1994|||APPR|
P860019|S087|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) INDY(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/1994|09/22/1994|||APPR|
P860019|S088|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) DYNA-MITE(T)PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/1994|12/13/1994|||APPR|
P860019|S089|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) NC COBRA(TM) 14 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1994|08/29/1994|||APPR|
P860019|S090|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1994|09/12/1994|||APPR|
P860019|S091|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/1994|09/27/1994|||APPR|
P860019|S093|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/1994|10/17/1994|||APPR|
P860019|S094|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/1994|12/07/1995|||APPR|APPROVAL FOR A CHANGE IN STERILIZATION PROCESS FROM 12/88 ETHYLENE OXIDE/CFC-12 TO 8.6/91.6 OXYFUME 2000 MIXTURE
P860019|S095|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/1994|01/23/1995|||APPR|
P860019|S096|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/1994|01/05/1995|||APPR|
P860022|S001|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/1988|08/22/1988|||APPR|
P860022|S002|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|02/03/1988|08/22/1988|||APPR|
P860022|S003|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|02/26/1988|08/22/1988|||APPR|
P860022|S004|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/1988|12/08/1988|||APPR|
P860022|S005|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/1988|10/26/1988|||APPR|
P860022|S006|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/1988|08/22/1988|||APPR|
P860022|S007|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1988|04/12/1989|||APPR|
P860022|S008|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1988|08/22/1988|||APPR|
P860022|S010|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/1988|08/22/1988|||APPR|
P860022|S011|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1988|03/15/1989|||APPR|
P860022|S012|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/1988|11/08/1988|||APPR|
P860022|S013|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/1988|12/13/1988|||APPR|
P860022|S014|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/16/1989|10/02/1989|||APPR|
P860022|S016|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/05/1989|12/27/1989|||APPR|
P860022|S017|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/1989|12/27/1989|||APPR|
P860022|S018|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1989|09/19/1989|||APPR|
P860022|S019|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/1989|09/19/1989|||APPR|
P860022|S020|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/1989|11/02/1989|||APPR|
P860022|S021|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/1989|12/11/1989|||APPR|
P860022|S022|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1989|01/31/1990|||APPR|
P860022|S023|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/1989|03/05/1990|||APPR|
P860022|S024|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (INAFLUOROFOCON) CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/1990|03/30/1990|||APPR|
P860022|S025|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (INAFLUOROFOCON) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/1990|03/29/1990|||APPR|
P860022|S026|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (INAFLUOROFOCON) CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1990|03/29/1990|||APPR|
P860022|S028|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (ITAFLUOROFOCON A)CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1990|06/25/1990|||APPR|
P860022|S029|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (ITAFLUOROFOCON A)CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/1990|10/24/1990|||APPR|
P860022|S030|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|THE BOSTON EQUALENS (ITAFLUOROFOCON A)CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1990|12/19/1990|||APPR|
P860022|S031|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1990|04/16/1991|||APPR|
P860022|S032|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/1990|02/04/1991|||APPR|
P860022|S033|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/1991|03/21/1991|||APPR|
P860022|S034|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/1991|04/05/1991|||APPR|
P860022|S035|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) EQUALENS(R) & BOSTON(R) RXD(TM)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1991|12/02/1991|||APPR|
P860022|S036|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1991|11/05/1992|||APPR|
P860022|S037|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/1992|01/14/1992|||APPR|
P860022|S038|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/1992|02/20/1992|||APPR|
P860022|S039|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) RXD(TM)& EQUALENS (TM) MANU.& DISTRIB.|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/1992|04/06/1992|||APPR|
P860022|S040|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) EQUALENS (R) SCLERAL CONTACT LENS DESIGN|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/1992|03/01/1994|||APPR|
P860022|S041|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON(R) EQUALENS (R) AND RXD (R) MANU./ DIST.|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1992|08/06/1992|||APPR|
P860022|S043|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON EQUALENS(R) AND BOSTON RXD(R)|HQD|OP|Normal 180 Day Track|Other Report|N|08/02/1993|09/07/1993|||APPR|
P860022|S044|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON EQUALENS(R) AND BOSTON RXD(R)|HQD|OP|Normal 180 Day Track|Other Report|N|08/02/1993|09/07/1993|||APPR|
P860022|S045|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON EQUALENS(R) AND BOSTON RXD(R)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/1994|02/16/1994|||APPR|
P860023|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES CLEANING/DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/1988|07/14/1988|||APPR|
P860023|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES CLEANING/DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/03/1988|10/26/1988|||APPR|
P860023|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES CLEANING/DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/19/1988|09/02/1988|||APPR|
P860023|S004|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES CLEANING/DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Other Report|N|10/14/1988|06/05/1989|||APPR|
P860023|S005|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES CLEANING/DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/1989|03/29/1990|||APPR|
P860023|S006|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/1991|01/24/1994|||APPR|
P860023|S008|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/1994|11/07/1994|||APPR|
P860026|S001|AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR|GZE|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/1989|09/29/1989|||APPR|
P860026|S002|AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR|GZE|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/17/1990|11/15/1990|||APPR|
P860026|S003|AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR|GZE|AN|Normal 180 Day Track||N|05/28/1991|11/06/1991|||APPR|
P860026|S004|AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR|GZE|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1993|03/03/1998|||APPR|Approval for bilateral stimulus output redundancy, external breathing rate control, antenna indicators which verify stimulus output and antenna integrity, concealed factory controls, additional covering to the battery connector, and design improvements to existing architecture that do no increase stimulus parameters above what was approved on January 5, 1987.  The device, as modified, will be marketed under the trade name mark IV and is indicated for persons who require chronic ventilatory support because of upper motor neuron respiratory muscle paralysis (RMP) or because of contral alveolar hypoventilation (CAH) and whose remaining phrenic nerve, lung, and diaphragm functions is sufficient ota ccommodate electrical stimulation.
P860027|S001|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO SERIES 500 P.G. MODELS 501, 505, 509|LWP|CV|Normal 180 Day Track|Other Report|N|10/14/1987|12/22/1987|||APPR|
P860027|S002|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO SERIES 500 P.G. MODELS 501, 505, 509|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1988|12/28/1988|||APPR|
P860027|S003|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO SERIES 500 P.G. MODELS 501, 505, 509|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/1988|10/18/1988|||APPR|
P860027|S004|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG|LWP|CV|Normal 180 Day Track|Other Report|N|03/20/1990|03/28/1990|||APPR|
P860027|S005|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1990|05/22/1990|||APPR|
P860027|S006|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1990|01/10/1991|||APPR|
P860027|S007|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/08/1990|01/30/1991|||APPR|
P860027|S008|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/1991|04/25/1991|||APPR|
P860027|S009|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO(R) RELEASE III SOFTWARE 5OO SERIES|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1992|06/03/1993|||APPR|
P860033|S001|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|HYPO-CARE STERILE SALINE SPRAY|LPN|OP|Normal 180 Day Track|Other Report|N|07/29/1987|12/01/1987|||APPR|
P860033|S002|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|HYPO-CARE STERILE SALINE SPRAY|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1987|10/27/1987|||APPR|
P860033|S003|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|HYPO-CARE STERILE SALINE SPRAY|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/12/1987|11/19/1987|||APPR|
P860033|S004|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|HYPO-CARE STERILE SALINE SPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/1989|01/05/1990|||APPR|
P860033|S005|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BUFFERED AEROSOL SALINE SOLUTION (BL-2700-NS9)|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1990|09/14/1990|||APPR|
P860034|S007|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL AC-21 OMNIFIT ANTERIOR CHAMBER|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/1990|06/15/1990|||APPR|
P860034|S008|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|ANTERIOR CHAMBER MONOFOCAL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/1991|02/21/1991|||APPR|
P860034|S009|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1992|11/09/1992|||APPR|
P860034|S010|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1992|11/09/1992|||APPR|
P860034|S011|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/13/1994|02/03/1995|||APPR|
P860035|S001|IVAC CORPORATION|10300 CAMPUS POINT DR.||SAN DIEGO|CA|92121||CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE|TITRATOR{TM} MODEL 10K|LSX|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/15/1989|05/01/1989|||APPR|
P860035|S002|IVAC CORPORATION|10300 CAMPUS POINT DR.||SAN DIEGO|CA|92121||CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE|TITRATOR{TM} MODEL 10K|LSX|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/22/1990|12/20/1990|||APPR|
P860035|S003|IVAC CORPORATION|10300 CAMPUS POINT DR.||SAN DIEGO|CA|92121||CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE|TITRATOR{TM} MODEL 10K|LSX|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1990|04/18/1991|||APPR|
P860035|S004|IVAC CORPORATION|10300 CAMPUS POINT DR.||SAN DIEGO|CA|92121||CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE|TITRATOR{TM} MODEL 10K|LSX|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/1990|12/28/1990|||APPR|
P860035|S005|IVAC CORPORATION|10300 CAMPUS POINT DR.||SAN DIEGO|CA|92121||CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE|TITRATOR{TM} MODEL 10K|LSX|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/1992|03/10/1993|||APPR|
P860040|S001|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1987|07/07/1987|||APPR|
P860040|S002|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|NPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/1987|05/01/1989|||APPR|
P860040|S003|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|1PHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1989|11/09/1990|||APPR|
P860040|S004|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|NPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/1989|07/27/1989|||APPR|
P860040|S006|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|NPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/19/1989|12/11/1989|||APPR|
P860040|S007|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1989|11/21/1990|||APPR|
P860040|S008|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/1990|10/29/1991|||APPR|
P860040|S009|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/1990|11/19/1990|||APPR|
P860040|S010|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/1991|08/29/1991|||APPR|
P860040|S011|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/1992|12/12/1994|||APPR|
P860040|S012|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/1993|01/27/1994|||APPR|
P860042|S001|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Other Report|N|04/28/1987|08/28/1987|||APPR|
P860042|S002|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/1987|07/14/1987|||APPR|
P860042|S003|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/1987|11/18/1987|||APPR|
P860042|S004|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1987|06/14/1988|||APPR|
P860042|S005|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/02/1988|10/07/1988|||APPR|
P860042|S006|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1988|02/09/1989|||APPR|
P860042|S007|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1988|01/24/1989|||APPR|
P860042|S008|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/21/1988|03/09/1990|||APPR|
P860042|S009|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/1988|04/19/1989|||APPR|
P860042|S010|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/1988|05/01/1989|||APPR|
P860042|S011|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1988|06/09/1989|||APPR|
P860042|S012|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/1988|06/06/1989|||APPR|
P860042|S013|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/10/1989|07/20/1989|||APPR|
P860042|S014|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/1989|07/21/1989|||APPR|
P860042|S015|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/1989|08/08/1989|||APPR|
P860042|S016|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/1989|06/06/1989|||APPR|
P860042|S017|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/1989|09/11/1990|||APPR|
P860042|S019|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/14/1989|06/09/1989|||APPR|
P860042|S020|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1989|02/01/1990|||APPR|
P860042|S021|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/1989|02/09/1990|||APPR|
P860042|S022|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/1989|03/06/1990|||APPR|
P860042|S023|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/1989|01/18/1990|||APPR|
P860042|S024|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1989|06/25/1990|||APPR|
P860042|S025|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/1990|02/25/1991|||APPR|
P860042|S026|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1991|03/17/1994|||APPR|
P860042|S027|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||Device. Laser peripheral angioplasty|TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE|LWX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/1993|03/01/1994|||APPR|
P860044|S001|BOEHRINGER MANNHEIM CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250|0457|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ENZYMUN-TEST{R} AFP|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1990|08/03/1990|||APPR|
P860044|S002|BOEHRINGER MANNHEIM CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250|0457|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ENZYMUN-TEST{R} AFP|LOJ|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1990|07/19/1991|||APPR|
P860044|S003|BOEHRINGER MANNHEIM CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250|0457|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ENZYMUN-TEST{R} AFP|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1990|09/03/1991|||APPR|
P860047|S001|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/1989|03/05/1990|||APPR|
P860047|S002|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/1990|05/21/1991|||APPR|
P860047|S003|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, MDR CORP.|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/1992|01/11/1993|||APPR|
P860047|S004|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, WORLD OPTICS|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/1992|01/11/1993|||APPR|
P860047|S005|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, DGR,INC.|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/28/1992|01/11/1993|||APPR|
P860047|S007|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/1993|06/30/1994|||APPR|
P860047|S008|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/1994|10/13/1994|||APPR|
P860050|S001|OPTOPICS LABORATORIES CORP.|P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|STERIDYNE DYNASPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/1987|11/17/1987|||APPR|
P860050|S002|OPTOPICS LABORATORIES CORP.|P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|STERIDYNE DYNASPRAY|LPN|OP|Normal 180 Day Track|Other Report|N|03/30/1987|07/07/1987|||APPR|
P860050|S005|OPTOPICS LABORATORIES CORP.|P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|STERIDYNE DYNASPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1987|05/09/1988|||APPR|
P860050|S006|OPTOPICS LABORATORIES CORP.|P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|STERIDYNE DYNASPRAY|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/1988|01/05/1989|||APPR|
P860050|S007|OPTOPICS LABORATORIES CORP.|P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|STERIDYNE DYNASPRAY|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/1990|05/31/1990|||APPR|
P860057|S001|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS, MODEL 2700|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/1994|01/04/1996|||APPR|APPROVAL FOR A NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS, MODEL 2700, AND APPROVAL FOR A REDUCED SEWING RING (RSR) VERSION OF THE VALVE WHICH WILL BE NAMED THE CARPENTIER-EDWARDS PERIMOUNT RSR BIOPROSTHESIS, MODEL 2800 AND APPROVAL FOR THE USE OF THE CURRENT MODEL 1161 VALVE SIZERS WITH THE MODEL 2800 VALVE, AND APPROVAL FOR A NEW SET OF VALVE SIZERS, MODEL 1127, FOR USE WITH THE MODEL 2700 VALVE. THE APPROVAL ALSO DISCONTINUES THE USE FO THE CURRENT DEVICE NAME, THE CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE ANEM CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS PERIMOUNT RSR BIOPROSTHESIS, MODEL 2800 AND WILL CONTINUE TO USE THE SAME INDICATIONS FOR USE AND REMAIN AVAILABLE IN THE AORTIC SIZES OF 19, 21, 23, 25, 27, AND 29MM
P860058|S001|BOEHRINGER MANNHEIM CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250|0457|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ENZYMUN TEST{R} CEA|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/1991|07/29/1993|||APPR|
P860059|S001|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1987|05/03/1988|||APPR|
P860059|S002|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1987|09/30/1988|||APPR|
P860059|S003|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|01/05/1988|10/17/1988|88M-0384|12/16/1988|APPR|
P860059|S004|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/1988|08/18/1988|||APPR|
P860059|S005|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/15/1988|01/31/1989|||APPR|
P860059|S006|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/1988|05/25/1988|||APPR|
P860059|S007|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1988|08/16/1988|||APPR|
P860059|S008|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1988|12/12/1988|||APPR|
P860059|S009|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/1988|01/26/1989|||APPR|
P860059|S010|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1988|02/06/1989|||APPR|
P860059|S011|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1988|02/21/1989|||APPR|
P860059|S013|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/1988|02/21/1989|||APPR|
P860059|S014|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/1988|02/21/1989|||APPR|
P860059|S015|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/1988|03/27/1989|||APPR|
P860059|S016|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1988|03/29/1989|||APPR|
P860059|S017|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Other Report|N|10/04/1988|05/05/1989|||APPR|
P860059|S019|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/1988|10/11/1989|||APPR|
P860059|S020|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/1988|10/19/1989|||APPR|
P860059|S021|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1988|10/19/1989|||APPR|
P860059|S023|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/10/1988|10/19/1989|||APPR|
P860059|S026|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/1988|10/19/1989|||APPR|
P860059|S029|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1988|10/19/1989|||APPR|
P860059|S031|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 304 (ULTRA C-LOOP)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1988|10/19/1989|||APPR|
P860059|S033|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS U260,U360,U360N,U365,U370,&UP383 LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1988|12/04/1989|||APPR|
P860059|S036|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS U260,U360,U360N,U365,U370,&UP383 LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1988|10/19/1989|||APPR|
P860059|S037|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS U260,U360,U360N,U365,U370,&UP383 LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/1989|08/18/1989|||APPR|
P860059|S045|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS U260,U360,U360N,U365,U370,&UP383 LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/1989|09/19/1989|||APPR|
P860059|S046|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS U260,U360,U360N,U365,U370,&UP383 LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/1989|12/13/1989|||APPR|
P860059|S048|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UB260S|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1989|02/16/1990|||APPR|
P860059|S049|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|UPB260S|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/1989|05/07/1990|||APPR|
P860059|S050|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/1990|12/04/1990|||APPR|
P860059|S051|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UP675 POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/1990|10/09/1991|||APPR|
P860059|S053|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UP350  -  POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/1990|10/09/1991|||APPR|
P860059|S054|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/1990|03/27/1992|||APPR|
P860059|S056|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MDOEL UPB380 POSTERIOR CHAMBER INTAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/28/1990|10/02/1992|||APPR|
P860059|S058|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS UB308E AND UB350ES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/1991|03/27/1992|||APPR|
P860059|S059|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UPB350S POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/1991|10/09/1991|||APPR|
P860059|S061|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UPB385 POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/16/1991|10/02/1992|||APPR|
P860059|S062|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UPB350NS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/16/1991|03/28/1994|||APPR|
P860059|S063|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UPB365 POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1991|10/01/1992|||APPR|
P860059|S064|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UPB240 POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/11/1991|10/30/1991|||APPR|
P860059|S065|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UPB380S POSTERIOR CHAMBER INTAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1991|03/03/1992|||APPR|
P860059|S066|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|UV-PMMA ALTERNATE VENDOR  /UV ABSORBING IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/1991|11/27/1991|||APPR|
P860059|S067|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UPB350FS UV/ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1991|11/06/1992|||APPR|
P860059|S068|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UP330F   UV/ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1991|03/09/1992|||APPR|
P860059|S069|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL UP350    UV/ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/1992|03/09/1992|||APPR|
P860059|S070|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|UV/ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/1992|08/15/1994|||APPR|
P860059|S071|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|UV/ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1992|10/01/1992|||APPR|
P860059|S073|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|UV/ABSORBING POSTERIOR CHAMBER IOL MODEL UPB330GS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/1992|08/05/1994|||APPR|
P860059|S074|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|UV/ABSORBING POSTERIOR CHAMBER IOL MODEL UPB330FS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/1992|08/05/1994|||APPR|
P860060|S001|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|CIBA VISION LENS DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/1988|08/08/1988|||APPR|
P860060|S002|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|CIBA VISION LENS DROPS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/1989|03/28/1990|||APPR|
P860061|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRAZYME PROTEIN CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1987|08/27/1987|||APPR|
P860061|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRAZYME PROTEIN CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1987|12/11/1987|||APPR|
P860061|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRAZYME PROTEIN CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/1988|08/09/1988|||APPR|
P860061|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRAZYME PROTEIN CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/1989|07/05/1990|||APPR|
P860061|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRAZYME PROTEIN CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/1989|03/25/1991|||APPR|
P860061|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALTRAZYME PROTEIN CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/30/1991|12/15/1993|||APPR|
P860061|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|HYDROZYME WEEKLY ENZYMATIC CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/11/1992|02/22/1994|||APPR|
P860061|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|HYDROZYME WEEKLY ENZYMATIC CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/1993|07/06/1994|||APPR|
P860061|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRAZYME(R) ENZYMATIC CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/24/1994|05/25/1995|||APPR|
P860062|S001|RESONEX, INC.|720 PALOMAR AVE.||SUNNYVALE|CA|94086||System, nuclear magnetic resonance imaging|RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST|LNH|RA|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|04/11/1988|05/25/1988|||APPR|
P860062|S002|RESONEX, INC.|720 PALOMAR AVE.||SUNNYVALE|CA|94086||System, nuclear magnetic resonance imaging|RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST|LNH|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1988|07/27/1988|||APPR|
P860064|S001|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DUPEN LONG TERM EPIDNRAL  CATHETER|LNY|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/1988|02/24/1989|||APPR|
P860064|S002|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DAVOL EXTERNALIZED EPIDURAL CATHETER|LNY|HO|Normal 180 Day Track|Other Report|N|09/06/1988|03/01/1989|||APPR|
P860064|S003|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DAVOL EXTERNALIZED EPIDURAL CATHETER|LNY|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1989|12/22/1989|||APPR|
P860064|S004|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DAVOL EXTERNALIZED EPIDURAL CATHETER|LNY|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/1989|06/11/1990|||APPR|
P860064|S005|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DAVOL EXTERNALIZED EPIDURAL CATHETER|LNY|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/1990|10/19/1990|||APPR|
P860064|S006|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DAVOL EXTERNALIZED EPIDURAL CATHETER|LNY|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/1991|12/26/1991|||APPR|
P860066|S001|VISIONCARE ASSOC.|480 SOUTH|SAN VICENTE BOULEVARD|LOS ANGELES|CA|90048||Accessories, soft lens products|ISOTONIC STERILE UNPRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/1987|06/10/1987|||APPR|
P860066|S002|VISIONCARE ASSOC.|480 SOUTH|SAN VICENTE BOULEVARD|LOS ANGELES|CA|90048||Accessories, soft lens products|ISOTONIC STERILE UNPRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/1988|03/03/1989|||APPR|
P870002|S001|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/1988|05/25/1988|||APPR|
P870002|S002|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/1988|04/20/1989|||APPR|
P870002|S003|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|07/25/1988|08/25/1988|||APPR|
P870002|S004|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/23/1989|04/05/1989|||APPR|
P870002|S005|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/1989|10/17/1989|||APPR|
P870002|S006|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/1989|02/16/1990|||APPR|
P870002|S009|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/1990|03/07/1991|||APPR|
P870002|S010|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1992|05/11/1993|||APPR|
P870002|S011|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/1992|09/01/1992|||APPR|
P870002|S012|APPLIED LABORATORIES, INC.|3240 NORTH INDIANAPOLIS RD.|P.O. BOX 448|COLUMBUS|IN|47201||Accessories, soft lens products|APPLIED LABORATORIES STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/1992|05/19/1994|||APPR|
P870005|S001|CIBA-GEIGY CORP.|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|IN A WINK CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1988|12/28/1988|||APPR|
P870005|S003|CIBA-GEIGY CORP.|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|IN A WINK CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/1989|07/31/1989|||APPR|
P870007|S001|OPTOPICS LABORATORIES CORP.|32 MAIN ST., P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|STERIDYNE STERILE PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1988|07/19/1988|||APPR|
P870007|S003|OPTOPICS LABORATORIES CORP.|32 MAIN ST., P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|SORBIC ACID PRESERVED SALINE SOLUTION|LPN|OP|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|05/11/1990|06/07/1990|||APPR|
P870007|S005|OPTOPICS LABORATORIES CORP.|32 MAIN ST., P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|SORBIC ACID PRESERVED SALINE SOL.PH CHANGE|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1992|02/25/1992|||APPR|
P870007|S006|OPTOPICS LABORATORIES CORP.|32 MAIN ST., P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|SORBIC ACID PRESERVED SALINE SOL.PH CHANGE|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/1992|04/14/1993|||APPR|
P870009|S001|3M COMPANY|3M CENTER|BLDG. 275-3SE-08|ST. PAUL|MN|55144|1000|Lens, contact (polymethylmethacrylate)|3M FLUOROPOLYMER CONTACT LENS (FLUROFOCON A)|HPX|OP|Panel Track|Change Design/Components/Specifications/Material|N|09/23/1987|06/21/1988|88M-0255|08/04/1988|APPR|
P870013|S002|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/22/1988|10/03/1988|||APPR|
P870013|S003|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1988|03/06/1990|||APPR|
P870013|S004|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/1989|03/19/1990|||APPR|
P870013|S005|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1989|12/11/1989|||APPR|
P870013|S006|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1989|09/28/1990|||APPR|
P870015|S001|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1988|06/28/1988|||APRL|
P870015|S002|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/1988|06/14/1988|||APRL|
P870015|S003|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/1988|10/26/1988|||APRL|
P870015|S008|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT|LNS|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/1989|09/13/1989|||APRL|
P870015|S009|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE 1050 EXTRACORPOREAL SHOCK WAVE LITHOTRIPT|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/20/1990|02/06/1991|||APRL|
P870015|S010|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE 1050 EXTRACORPOREAL SHOCK WAVE LITHOTRIPT|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1990|12/24/1990|||APRL|
P870015|S012|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/1991|11/07/1991|||APRL|
P870015|S013|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1991|08/13/1992|||APRL|
P870015|S015|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/1992|05/19/1992|||APRL|
P870015|S016|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1992|07/13/1992|||APRL|
P870015|S017|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/1992|07/27/1992|||APRL|
P870015|S018|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1992|12/22/1994|||APRL|
P870015|S019|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/1994|01/06/1995|||APRL|
P870015|S020|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Other Report|N|04/12/1994|04/19/1994|||APRL|
P870017|S001|VISIONCARE ASSOC.|480 SOUTH|SAN VICENTE BOULEVARD|LOS ANGELES|CA|90048||Accessories, soft lens products|VIS-SOL STERILE PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1987|10/19/1987|||APPR|
P870017|S002|VISIONCARE ASSOC.|480 SOUTH|SAN VICENTE BOULEVARD|LOS ANGELES|CA|90048||Accessories, soft lens products|VIS-SOL STERILE PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/1990|07/05/1990|||APPR|
P870018|S001|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1988|04/18/1989|||APRL|
P870018|S002|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/1989|08/08/1989|||APRL|
P870018|S003|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Other Report|N|11/15/1990|12/24/1990|||APRL|
P870018|S004|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/07/1990|03/18/1991|||APRL|
P870018|S005|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/1991|02/05/1992|||APRL|
P870018|S006|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR CHANGES TO SETTING AND MONITOR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1992|08/11/1992|||APRL|
P870018|S007|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR CHANGES TO SETTING AND MONITOR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1992|10/05/1992|||APRL|
P870018|S008|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Other Report|N|02/07/1994|05/05/1994|||APRL|
P870018|S009|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/1994|05/04/1994|||APRL|
P870019|S001|HANITA CONTACT LENS LABORATORY|333 EAST 57TH ST.||NEW YORK|NY|10022||Lenses, soft contact, daily wear|ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/1989|11/20/1989|||APPR|
P870019|S002|HANITA CONTACT LENS LABORATORY|333 EAST 57TH ST.||NEW YORK|NY|10022||Lenses, soft contact, daily wear|ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/14/1989|12/11/1989|||APPR|
P870019|S003|HANITA CONTACT LENS LABORATORY|333 EAST 57TH ST.||NEW YORK|NY|10022||Lenses, soft contact, daily wear|ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/1989|03/28/1990|||APPR|
P870021|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Catheters, transluminal coronary angioplasty, percutaneous|PRIME{TM} MODEL 6520, 6525, 6530 AND 6535|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/1988|10/13/1988|||APPR|
P870021|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Catheters, transluminal coronary angioplasty, percutaneous|PRIME{TM} MODEL 6520, 6525, 6530 AND 6535|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/19/1988|04/18/1989|||APPR|
P870021|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Catheters, transluminal coronary angioplasty, percutaneous|PRIME{TM} MODEL 6520, 6525, 6530 AND 6535|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/1989|09/05/1989|||APPR|
P870021|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Catheters, transluminal coronary angioplasty, percutaneous|PRIME{TM} MODEL 6520, 6525, 6530 AND 6535|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1990|10/04/1990|||APPR|
P870023|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|DE-STAT 3 CLEANING SOAKING CONDITIONING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/1989|01/14/1991|||APPR|
P870023|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SYSTEM -3 CLEANING/DISINFECTING STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/1992|08/24/1993|||APPR|
P870023|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|BRITE STOCK CLEANING / DISINFECTING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/10/1993|01/04/1994|||APPR|
P870024|S001|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/1987|04/11/1988|||APPR|
P870024|S002|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Panel Track|Change Design/Components/Specifications/Material|N|03/09/1988|05/31/1988|88M-0220|07/12/1988|APPR|
P870024|S003|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1988|11/15/1988|||APPR|
P870024|S004|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1988|11/15/1988|||APPR|
P870024|S005|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/1988|03/09/1989|||APPR|
P870024|S007|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/1989|03/27/1989|||APPR|
P870024|S008|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1989|05/31/1989|||APPR|
P870024|S009|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/1989|12/27/1989|||APPR|
P870024|S010|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/1989|12/27/1989|||APPR|
P870024|S011|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/1989|03/30/1990|||APPR|
P870024|S012|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1989|03/30/1990|||APPR|
P870024|S013|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/1989|01/16/1990|||APPR|
P870024|S014|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/1989|11/22/1989|||APPR|
P870024|S015|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM RGP CONTACT LENSES|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/1989|07/12/1990|||APPR|
P870024|S016|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/1990|03/29/1990|||APPR|
P870024|S017|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1990|05/08/1990|||APPR|
P870024|S018|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/1990|07/05/1990|||APPR|
P870024|S019|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/1990|10/25/1990|||APPR|
P870024|S020|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/1990|07/13/1990|||APPR|
P870024|S022|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/1990|10/31/1990|||APPR|
P870024|S023|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/1990|02/12/1991|||APPR|
P870024|S024|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/1990|02/05/1991|||APPR|
P870024|S025|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/18/1991|06/28/1991|||APPR|
P870024|S026|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1991|08/15/1991|||APPR|
P870024|S027|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/1991|10/23/1991|||APPR|
P870024|S029|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM 60 (PAFLUFOCON B) CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/06/1991|06/22/1993|||APPR|
P870024|S030|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A, B, AND C) CONTACT LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/12/1991|02/25/1992|||APPR|
P870024|S031|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A)ALTERNATE MANU.SITE|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1992|02/25/1992|||APPR|
P870024|S032|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A)ALTERNATE MANU.SITE|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/1992|03/30/1992|||APPR|
P870024|S033|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A,B,C )VIOLET TINT|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/1992|12/30/1992|||APPR|
P870024|S034|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A,B,C )CLEAR & TINTS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/1992|11/25/1992|||APPR|
P870024|S035|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM (PAFLUFOCON A,B,C )CLEAR & TINTS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1992|01/26/1993|||APPR|
P870024|S036|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM 151 (PAFLUFOCON D) CLEAR & TINTS W/O UV|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1992|11/23/1993|||APPR|
P870024|S037|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/1993|04/02/1993|||APPR|
P870024|S038|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/1993|04/14/1993|||APPR|
P870024|S039|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/04/1994|||APPR|
P870024|S040|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/04/1994|||APPR|
P870025|S001|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY|MCP|OB|Special (Immediate Track)|Other Report|N|10/11/1988|10/20/1988|||APPR|
P870025|S002|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR|MCP|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/1994|04/13/1995|||APPR|
P870026|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|DURACLEAN(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
P870026|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|DURACLEAN(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
P870026|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|0URACLEAN(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/1990|03/29/1990|||APPR|
P870026|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|RESOLVE/GP(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Other Report|N|07/25/1990|12/30/1992|||APPR|
P870026|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|RESOLVE/GP(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/1992|09/28/1993|||APPR|
P870029|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|STAY WET 3 & STAY WET 3 (SA)|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1989|12/28/1989|||APPR|
P870029|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|STAY WET 3 & STAY WET 3 (SA)|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/1990|01/14/1991|||APPR|
P870029|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SYSTEM 3 WETTING IN EYE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/1992|09/29/1993|||APPR|
P870029|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|BRITE STOCK RE-WETTING/COMFORT DROPS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/1993|01/04/1994|||APPR|
P870036|S001|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/1988|08/10/1988|||APPR|
P870036|S002|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1989|04/19/1989|||APPR|
P870036|S003|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/1989|06/06/1989|||APPR|
P870036|S004|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/1989|06/20/1989|||APPR|
P870036|S005|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/1989|06/23/1989|||APPR|
P870036|S006|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/1989|02/07/1990|||APPR|
P870036|S007|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1989|06/25/1990|||APPR|
P870036|S008|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/08/1990|12/18/1990|||APPR|
P870036|S009|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1990|12/20/1990|||APPR|
P870036|S010|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|BUSHINDER THRUFLEX OVER-THE-WIRE BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/1990|01/30/1991|||APPR|
P870036|S011|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|BUSHINDER OMNIFLEX OVER-THE-WIRE BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/1991|03/20/1991|||APPR|
P870036|S012|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) 18K(TM) OVER THE WIRE BALL. CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/1991|10/04/1991|||APPR|
P870036|S013|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC BUSHBINDER(R) OMNIFLEX(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/1991|02/12/1993|||APPR|
P870036|S014|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) 14K OVER THE WIRE CORONARY BALL.CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/12/1991|02/13/1992|||APPR|
P870036|S015|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) 18K(TM) OVER-THE-WIRE CORO.BALL.CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1991|06/22/1992|||APPR|
P870036|S016|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) CORONARY BALLOON DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/1992|08/03/1992|||APPR|
P870036|S017|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R)THRUFLEX(TM) II OVER-THE-WIRE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|12/24/1992|||APPR|
P870036|S018|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R)THRUFLEX(TM) II OVER-THE-WIRE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/1992|12/29/1992|||APPR|
P870036|S019|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/16/1992|04/28/1993|||APPR|
P870036|S020|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1992|05/04/1993|||APPR|
P870036|S021|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/1992|08/27/1993|||APPR|
P870036|S023|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) SPIRIT(TM) CORONARY BALL. DILAT. CATH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/05/1993|08/06/1993|||APPR|
P870036|S024|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) 14K(TM)CORONARY BALL DILATATION CATH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/1993|08/09/1993|||APPR|
P870036|S025|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) 14K(TM)CORONARY BALL DILATATION CATH|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1993|11/09/1994|||APPR|
P870036|S026|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) RAIDER(TM) CORONARY BALL. DILI. CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/29/1993|11/04/1993|||APPR|
P870036|S027|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R)PANTHER(TM) CORONARY BALL. DILI. CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1993|11/05/1993|||APPR|
P870036|S028|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R)SPIRIT(TM)30 & 40 COR.BALL. DIL. CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/1994|07/26/1994|||APPR|
P870036|S029|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) PANTHER (TM) 40 COR..BALL. DIL. CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1994|08/30/1994|||APPR|
P870036|S030|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) EVERGREEN(TM) COR.BALL.DIL. CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1994|08/30/1994|||APPR|
P870036|S031|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) FALCON(TM) COR. BALL. DIL. CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/1994|02/15/1995|||APPR|
P870036|S032|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) EVERGREEN 40 CORONARY BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1994|04/27/1995|||APPR|
P870037|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/30/1987|02/08/1988|||APPR|
P870037|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/30/1987|07/21/1988|||APPR|
P870037|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1988|08/31/1988|||APPR|
P870037|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/1988|06/05/1989|||APPR|
P870037|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/1989|08/15/1990|||APPR|
P870037|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1989|10/24/1989|||APPR|
P870043|S001|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/1988|12/15/1988|||APPR|
P870043|S002|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/13/1988|11/30/1989|||APPR|
P870043|S003|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/1988|04/19/1989|||APPR|
P870043|S004|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1988|09/26/1989|||APPR|
P870043|S005|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/1988|06/06/1989|||APPR|
P870043|S006|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/10/1989|07/20/1989|||APPR|
P870043|S007|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/1989|09/12/1990|||APPR|
P870043|S008|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/1989|04/04/1990|||APPR|
P870043|S009|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/1989|12/13/1989|||APPR|
P870043|S010|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1989|06/25/1990|||APPR|
P870043|S011|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/1990|11/14/1990|||APPR|
P870043|S013|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/1990|08/20/1991|||APPR|
P870043|S014|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/23/1991|01/29/1992|||APPR|
P870043|S015|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/1991|03/20/1992|||APPR|
P870043|S016|TRIMEDYNE, INC.|25901 COMMERCENTRE DR||LAKE FOREST|CA|92630||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1991|03/17/1994|||APPR|
P870045|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODELS SK53UM & SK57UM|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1988|02/02/1990|||APPR|
P870045|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODELS CM52UB & CM53UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1988|02/02/1990|||APPR|
P870045|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL SK52UB & SK58UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1988|02/02/1990|||APPR|
P870045|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL SAL1U|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1988|02/02/1990|||APPR|
P870045|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODELS SP14UB & SP15UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/1988|02/02/1990|||APPR|
P870045|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODELS SK11U,SK14U,SK15U, & SK16U|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/1988|02/02/1990|||APPR|
P870045|S009|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODELS SP13UB & SP16UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/1988|06/05/1990|||APPR|
P870045|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CM14U AND CM15U|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1988|02/02/1990|||APPR|
P870045|S011|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|SP12UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1988|06/05/1990|||APPR|
P870045|S016|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/1990|03/29/1990|||APPR|
P870045|S017|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL SAL2UB|HQL|OP|Normal 180 Day Track|Other Report|N|02/28/1990|05/28/1991|||APPR|
P870045|S018|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV ABSORBING POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Other Report|N|03/22/1990|06/22/1990|||APPR|
P870045|S019|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/28/1990|07/20/1990|||APPR|
P870045|S020|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/1990|05/09/1990|||APPR|
P870045|S021|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Other Report|N|07/12/1990|08/15/1990|||APPR|
P870045|S022|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL SAL3UB UV POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/1990|12/13/1990|||APPR|
P870045|S023|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL SP17UB UV POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1990|03/20/1991|||APPR|
P870045|S024|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Other Report|N|09/13/1990|12/19/1990|||APPR|
P870045|S025|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|TIER A - LENS MODEL SP18UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/17/1990|09/05/1991|||APPR|
P870045|S026|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|TIER B - LENS MODEL SP24UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/1991|08/22/1991|||APPR|
P870045|S027|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|TIER A - LENS MODEL CM11UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/15/1991|08/22/1991|||APPR|
P870045|S028|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|TIER A - LENS MODEL SP29UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1991|02/21/1992|||APPR|
P870045|S029|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/1991|11/17/1993|||APPR|
P870045|S031|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL CM19UB POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/10/1991|12/06/1991|||APPR|
P870045|S032|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL JM19UB POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1991|12/06/1991|||APPR|
P870045|S033|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL JM19UB POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/10/1991|07/28/1994|||APPR|
P870045|S034|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/1992|06/24/1992|||APPR|
P870045|S035|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES MODEL CM21U|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1993|08/11/1994|||APPR|
P870045|S036|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES MODEL SP38UB|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1993|08/11/1995|||APPR|APPROVAL FOR MODEL SP38UB
P870048|S001|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|EBK|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/1990|01/10/1991|||APPR|
P870049|S001|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/13/1988|03/16/1989|||APPR|
P870049|S002|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/1989|08/02/1989|||APPR|
P870049|S003|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/20/1989|10/03/1989|||APPR|
P870049|S004|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/1989|01/22/1990|||APPR|
P870049|S005|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/1989|08/03/1990|||APPR|
P870049|S008|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/1990|12/20/1990|||APPR|
P870049|S009|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/1990|01/08/1991|||APPR|
P870049|S010|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/1990|01/08/1991|||APPR|
P870049|S011|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN(R) WALKAWAY(TM)-40|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1991|11/06/1991|||APPR|
P870049|S012|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN(R)|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/1991|11/06/1991|||APPR|
P870049|S013|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN(R)|LON|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/1991|11/06/1991|||APPR|
P870049|S014|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN(R)|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/1991|03/12/1993|||APPR|
P870049|S015|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/29/1991|12/18/1991|||APPR|
P870049|S016|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/1992|02/28/1992|||APPR|
P870049|S018|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|RAPID POSITIVE MIC PANEL|LON|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/1993|05/09/1994|||APPR|
P870049|S020|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|10/20/1993|02/10/1994|||APPR|
P870049|S021|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/1994|10/04/1994|||APPR|
P870049|S022|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/1994|12/08/1994|||APPR|
P870050|S001|TRP COMPANY|1575 DELUCCI LANE #115||RENO|NV|89502||Accessories, soft lens products|SEREINE CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1990|12/12/1990|||APPR|
P870050|S003|TRP COMPANY|1575 DELUCCI LANE #115||RENO|NV|89502||Accessories, soft lens products|SEREINE CLEANER,15ML NEW SAMPLE SIZE|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1991|01/28/1992|||APPR|
P870051|S001|TRP COMPANY|1575 DELUCCI LANE #115||RENO|NV|89502||Accessories, soft lens products|SEREINE WETTING & SOAKING SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1990|12/06/1990|||APPR|
P870051|S003|TRP COMPANY|1575 DELUCCI LANE #115||RENO|NV|89502||Accessories, soft lens products|SEREINE WETTING & SOAKING SOLUTION 15ML SAMPLE SIZ|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1991|01/28/1992|||APPR|
P870054|S001|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/10/1988|03/29/1989|||APPR|
P870054|S002|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/17/1989|03/22/1989|||APPR|
P870054|S003|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/23/1989|09/19/1989|||APPR|
P870054|S004|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/13/1989|06/20/1989|||APPR|
P870054|S005|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/1989|12/06/1989|||APPR|
P870054|S006|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1989|07/31/1989|||APPR|
P870054|S009|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1989|10/31/1990|||APPR|
P870054|S010|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|MODEL Q (UNIPOLAR) & R (BIPOLAR) ENDOCARDIAL LEADS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/1990|06/19/1990|||APPR|
P870054|S011|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN (R) PACING SYSTEM|DXY|CV|Normal 180 Day Track|Other Report|N|03/05/1990|03/19/1990|||APPR|
P870058|S001|ARMSTRONG LABORATORIES, INC.|423 LA GRANGE ST.||WEST ROXBURY|MA|02132||Accessories, soft lens products|ARMSTRONG STERILE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/1988|10/13/1988|||APPR|
P870059|S001|ACTECH ADVANCED CLINICAL TECHNOLOGIES, INC.|117 BROADWAY||NORWOOD,|MA|02062||KIT, TEST, IN VITRO PERIODONTAL|PERIOCHECK TM ENZYME ACTIVITY TEST KIT|MCL|CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/06/1991|10/16/1991|||APPR|
P870062|S002|LAMBERTS DALSTON LTD.|DALSTON HOUSE, HASTINGS ST.||LUTON, BEDS.||LU1 5||CAP, CERVICAL, CONTRACEPTIVE|PRENTIF TM CAVITY RIM CERVICAL CAP|LLQ|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1991|08/20/1991|||APPR|
P870069|S001|UDL LABORATORIES, INC.|12720 DAIRY ASHFORD||SUGAR LAND|TX|77478||Dressing, wound, drug|BIOBRANE|FRO|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/1989|03/08/1990|||APPR|
P870069|S003|UDL LABORATORIES, INC.|12720 DAIRY ASHFORD||SUGAR LAND|TX|77478||Dressing, wound, drug|BIOBRANE (R) II BLUE LABEL PRODUCT|FRO|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/1990|02/22/1991|||APPR|
P870071|S001|G V MEDICAL, INC,|3750 ANNAPOLIS LN.||MINNEAPOLIS|MN|55441||DEVICE, ANGIOPLASTY, LASER, CORONARY|LASTAC SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1988|02/02/1989|||APPR|
P870071|S002|G V MEDICAL, INC,|3750 ANNAPOLIS LN.||MINNEAPOLIS|MN|55441||DEVICE, ANGIOPLASTY, LASER, CORONARY|LASTAC SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1988|04/04/1989|||APPR|
P870071|S003|G V MEDICAL, INC,|3750 ANNAPOLIS LN.||MINNEAPOLIS|MN|55441||DEVICE, ANGIOPLASTY, LASER, CORONARY|LASTAC SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1988|04/06/1989|||APPR|
P870071|S004|G V MEDICAL, INC,|3750 ANNAPOLIS LN.||MINNEAPOLIS|MN|55441||DEVICE, ANGIOPLASTY, LASER, CORONARY|LASTAC SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1988|03/30/1989|||APPR|
P870071|S005|G V MEDICAL, INC,|3750 ANNAPOLIS LN.||MINNEAPOLIS|MN|55441||DEVICE, ANGIOPLASTY, LASER, CORONARY|LASTAC SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/1989|03/31/1989|||APPR|
P870071|S006|G V MEDICAL, INC,|3750 ANNAPOLIS LN.||MINNEAPOLIS|MN|55441||DEVICE, ANGIOPLASTY, LASER, CORONARY|LASTAC SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/1989|06/25/1991|||APPR|
P870071|S007|G V MEDICAL, INC,|3750 ANNAPOLIS LN.||MINNEAPOLIS|MN|55441||DEVICE, ANGIOPLASTY, LASER, CORONARY|LASTAC SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/1990|02/08/1991|||APPR|
P870071|S008|G V MEDICAL, INC,|3750 ANNAPOLIS LN.||MINNEAPOLIS|MN|55441||DEVICE, ANGIOPLASTY, LASER, CORONARY|LASTAC SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/1990|08/06/1991|||APPR|
P870073|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1988|12/22/1989|||APPR|
P870073|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/1988|11/30/1989|||APPR|
P870073|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/1990|03/05/1990|||APPR|
P870073|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1990|09/26/1990|||APPR|
P870073|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/1990|10/24/1990|||APPR|
P870073|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/08/1991|03/28/1994|||APPR|
P870073|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/10/1992|04/28/1993|||APPR|
P870073|S009|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1992|04/10/1992|||APPR|
P870073|S012|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1992|01/26/1995|||APPR|
P870073|S013|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/1992|08/09/1994|||APPR|
P870073|S014|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL KR10UV,THREE PIECE IOL/W PMMA HAPTICS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/1993|06/27/1994|||APPR|
P870073|S015|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL KR10UV,THREE PIECE IOL/W PMMA HAPTICS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/1994|07/29/1994|||APPR|
P870075|S001|NEWLENSCO|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|CLASSIC SERIES TM POSTERIOR CHAMBER INTRAOCULAR|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|08/10/1988|12/06/1989|||APPR|
P870075|S003|NEWLENSCO|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|NEWLENSCO CLASSIC SERIES(TM) MODEL MP-2410 TIER B|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/1991|09/13/1991|||APPR|
P870075|S004|NEWLENSCO|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|NEWLENSCO CLASSIC SERIES(TM) MODEL MP-2410 TIER B|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/1991|12/06/1991|||APPR|
P870077|S001|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|LOW PRESSURE BIOPROSTHESIS (MODELS 6625LP & 6625)|DYE|CV|Normal 180 Day Track|Other Report|N|08/05/1993|09/24/1993|||APPR|
P870078|S001|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK I BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/1989|11/09/1989|||APPR|
P870078|S002|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK   BIOPROSTHESIS MODELS 242,342,343C,342R|DYE|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/1992|01/29/1993|||APPR|
P870078|S003|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK   BIOPROSTHESIS MODELS 242,342,343C,342R|DYE|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/1992|07/02/1993|||APPR|
P870079|S001|UNITED CONTACT LENS, INC.|917-134TH ST. S.W., #A-4||EVERETT|WA|98204||Lenses, soft contact, daily wear|TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/1988|05/26/1989|||APPR|
P870079|S002|UNITED CONTACT LENS, INC.|917-134TH ST. S.W., #A-4||EVERETT|WA|98204||Lenses, soft contact, daily wear|TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/1988|06/02/1989|||APPR|
P870079|S003|UNITED CONTACT LENS, INC.|917-134TH ST. S.W., #A-4||EVERETT|WA|98204||Lenses, soft contact, daily wear|TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/1989|03/29/1990|||APPR|
P870079|S005|UNITED CONTACT LENS, INC.|917-134TH ST. S.W., #A-4||EVERETT|WA|98204||Lenses, soft contact, daily wear|TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1989|01/22/1990|||APPR|
P880001|S001|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/1988|11/10/1988|||APPR|
P880001|S002|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1988|03/28/1989|||APPR|
P880001|S003|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1988|02/10/1989|||APPR|
P880001|S004|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1988|12/29/1988|||APPR|
P880001|S005|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1988|01/26/1989|||APPR|
P880001|S006|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/1988|02/09/1989|||APPR|
P880001|S007|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/1989|02/09/1989|||APPR|
P880001|S008|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/1989|07/20/1990|||APPR|
P880001|S009|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/1989|04/19/1989|||APPR|
P880001|S010|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Other Report|N|02/16/1989|07/25/1989|||APPR|
P880001|S011|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1989|03/27/1989|||APPR|
P880001|S012|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/1989|04/18/1989|||APPR|
P880001|S013|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1989|05/05/1989|||APPR|
P880001|S014|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1989|11/20/1989|||APPR|
P880001|S015|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/1989|09/08/1989|||APPR|
P880001|S016|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1989|07/20/1990|||APPR|
P880001|S017|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1989|09/22/1989|||APPR|
P880001|S018|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1989|09/22/1989|||APPR|
P880001|S019|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1989|09/22/1989|||APPR|
P880001|S020|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1989|02/09/1990|||APPR|
P880001|S021|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/1989|11/03/1989|||APPR|
P880001|S023|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|8LUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/1989|11/22/1989|||APPR|
P880001|S024|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|8LUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1989|12/28/1989|||APPR|
P880001|S025|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|8LUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/1990|05/22/1990|||APPR|
P880001|S026|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|8LUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/1990|06/26/1990|||APPR|
P880001|S027|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|8LUOREX (TM) 600 (FLURSILFOCON A)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/1990|08/09/1990|||APPR|
P880001|S028|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/06/1990|03/18/1991|||APPR|
P880001|S029|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/1990|12/12/1990|||APPR|
P880001|S030|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM)  FLUSILFOCON) 700,500,300 RGP LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/1991|08/21/1991|||APPR|
P880001|S031|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1991|07/27/1992|||APPR|
P880001|S032|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/1992|02/14/1992|||APPR|
P880001|S033|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/1992|04/14/1992|||APPR|
P880001|S034|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/1992|05/04/1992|||APPR|
P880001|S035|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/1992|06/26/1992|||APPR|
P880001|S036|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1992|09/30/1992|||APPR|
P880001|S037|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/1993|03/31/1993|||APPR|
P880001|S038|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1993|05/11/1993|||APPR|
P880001|S039|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|08/24/1993|09/15/1993|||APPR|
P880001|S040|G.T. LABORATORIES, INC.|111 NO. WABASH AVE.||CHICAGO|IL|60602||Lens, contact (other material) - daily|FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1993|11/23/1993|||APPR|
P880003|S001|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/1988|01/11/1989|||APPR|
P880003|S003|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/1989|03/31/1989|||APPR|
P880003|S005|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|HELIX PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/1990|08/06/1991|||APPR|
P880003|S006|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|HELIX PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/1991|10/04/1991|||APPR|
P880003|S007|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|HELIX PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/1992|06/12/1992|||APPR|
P880003|S008|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|HELIX UPGRADE PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1992|12/18/1992|||APPR|
P880003|S009|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|HELIX PTCA DILATION CATHETERS AND Y- CONNECTORS|LOX|CV|Normal 180 Day Track|Other Report|N|05/21/1992|07/13/1992|||APPR|
P880003|S010|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|SLEEK PTCA DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/1992|06/17/1993|||APPR|
P880003|S011|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|OLYMPIX & SLEUTH XT PTCA CATHETERS W/3CM BALLOONS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1992|06/17/1993|||APPR|
P880003|S012|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|OLYMPIX & SLEUTH XT PTCA CATHETERS W/4CM BALLOONS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/1992|06/17/1993|||APPR|
P880003|S013|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|SLEEK PTCA DILATATION CATHETERS W/3 & 4CM BALLONS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1992|07/07/1993|||APPR|
P880003|S014|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PREDATOR PTCA DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/12/1993|07/21/1993|||APPR|
P880003|S015|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PREDATOR PTCA DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/16/1993|08/20/1993|||APPR|
P880003|S016|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS OLYMPIX,SLEEK, & PREDATOR PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/1993|09/23/1993|||APPR|
P880003|S017|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS OLYMPIX,SLEUTH,& PREDATOR PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/1993|01/12/1994|||APPR|
P880003|S018|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS SLEEK PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/1993|07/29/1993|||APPR|
P880003|S019|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1993|08/02/1993|||APPR|
P880003|S020|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/1993|01/07/1994|||APPR|
P880003|S021|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/1993|01/27/1994|||APPR|
P880003|S023|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS EUROPASS PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1993|09/30/1994|||APPR|
P880003|S024|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS SLEEK PLUS PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/26/1993|04/20/1994|||APPR|
P880003|S025|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILITATION CARTHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/1993|08/04/1995|||APPR|APPROVAL FOR ALTERNATE STERILIZATION SITE AND ELIMINATION OF CHLOROFLUOROCARBONS (CFC'S) FROM THE STERILIZATION PROCESS
P880003|S026|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|QRAKSTAR 14 PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/27/1993|08/18/1994|||APPR|
P880003|S027|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|TRAKSTAR 18 PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/06/1994|08/12/1994|||APPR|
P880003|S028|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS WORLDPASS PTCA DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/14/1994|09/29/1994|||APPR|
P880003|S029|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS SLEEK DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/29/1994|09/29/1994|||APPR|
P880003|S030|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PREDATOR PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/1994|09/29/1994|||APPR|
P880003|S031|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS BASIC 18 PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1994|10/25/1994|||APPR|
P880003|S032|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1994|03/09/1995|||APPR|
P880003|S033|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1994|03/21/1995|||APPR|
P880006|S001|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1989|04/03/1990|||APPR|
P880006|S002|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/1989|08/29/1989|||APPR|
P880006|S004|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1989|05/04/1990|||APPR|
P880006|S005|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM|DXY|CV|Normal 180 Day Track|Other Report|N|11/13/1989|01/18/1990|||APPR|
P880006|S006|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/1990|04/03/1990|||APPR|
P880006|S007|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B|DXY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/10/1990|05/30/1990|||APPR|
P880006|S008|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/28/1990|09/03/1991|||APPR|
P880006|S009|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/1991|01/11/1993|||APPR|APPROVAL FOR RELOCATING THE MANUFACTURING FACILITIES TO 15900 VALLEYVIEW COURT, SYLMAR, CA., 91392-9221
P880006|S010|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APS-II MODEL 3003 PROGRAMMER|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/1991|09/16/1991|||APPR|
P880006|S011|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3037A FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/1991|12/24/1991|||APPR|
P880006|S012|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG(R)III & DIALOG(R)II PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/09/1991|02/25/1992|||APPR|
P880006|S013|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3038 FUNCTION PACK FOR ASP-II 3003 PROGRAMME|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1991|04/14/1992|||APPR|
P880006|S014|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG (R) ALTERNATE PRODUCT TRAY|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|11/18/1992|||APPR|
P880006|S016|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG (R) MODEL 3038 SOFTWARE MODIFICATION|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1992|01/22/1993|||APPR|
P880006|S017|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG (R)  ULTILOG (TM) MODELS 2040K,2040T|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1993|01/12/1995|||APPR|
P880006|S018|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG (R)MODEL 3039 FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/1993|07/12/1994|||APPR|
P880006|S020|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|OG(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/26/1993|09/27/1994|||APPR|
P880006|S021|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1994|03/27/1995|||APPR|
P880009|S001|QIAGEN, INC.|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT|MAQ|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/1989|06/06/1989|||APPR|
P880009|S002|QIAGEN, INC.|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/1989|08/21/1989|||APPR|
P880009|S003|QIAGEN, INC.|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT|MAQ|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/1989|02/01/1990|||APPR|
P880009|S004|QIAGEN, INC.|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT|MAQ|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/24/1991|08/19/1991|||APPR|
P880009|S005|QIAGEN, INC.|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT|MAQ|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/1991|05/17/1993|||APPR|
P880010|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|10/13/1988|05/04/1989|89M-0187|06/29/1989|APPR|
P880010|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|11/04/1988|08/17/1989|89M-0357|04/05/1990|APPR|
P880010|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1988|11/06/1989|||APPR|
P880010|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/1988|10/23/1989|||APPR|
P880010|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1988|01/30/1990|||APPR|
P880010|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/27/1988|01/16/1990|||APPR|
P880010|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1988|01/16/1990|||APPR|
P880010|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/1989|01/16/1990|||APPR|
P880010|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|INTRAOCULAR LENS MODELS C118;C119;C138 AND C139|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/1991|03/24/1992|||APPR|
P880010|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P880010|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|LASER WELDING REVERSE HAPTIC ASPECT RATIO|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/1992|05/05/1994|||APPR|
P880011|S001|EDAP INTERNATIONAL CORP.|TWO BURLINGTON WOODS||BURLINGTON|MA|01803||Lithotriptor, extracorporeal shock-wave,urological|TECHNOMED INTERNATIONAL SONOLITH 2000|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/1989|06/27/1989|||APRL|
P880011|S002|EDAP INTERNATIONAL CORP.|TWO BURLINGTON WOODS||BURLINGTON|MA|01803||Lithotriptor, extracorporeal shock-wave,urological|TECHNOMED INTERNATIONAL SONOLITH 2000|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/1989|12/27/1989|||APRL|
P880011|S003|EDAP INTERNATIONAL CORP.|TWO BURLINGTON WOODS||BURLINGTON|MA|01803||Lithotriptor, extracorporeal shock-wave,urological|TECHNOMED INTERNATIONAL SONOLITH 2000|LNS|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1990|09/06/1995|||APRL|
P880011|S004|EDAP INTERNATIONAL CORP.|TWO BURLINGTON WOODS||BURLINGTON|MA|01803||Lithotriptor, extracorporeal shock-wave,urological|TECHNOMED INTERNATIONAL SONOLITH 2000|LNS|GU|Normal 180 Day Track|Other Report|N|09/24/1990|12/24/1990|||APRL|
P880011|S007|EDAP INTERNATIONAL CORP.|TWO BURLINGTON WOODS||BURLINGTON|MA|01803||Lithotriptor, extracorporeal shock-wave,urological|TECHNOMED INTERNATIONAL SONOLITH 3000 (LITHORAY)TM|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1991|02/10/1992|||APRL|
P880011|S008|EDAP INTERNATIONAL CORP.|TWO BURLINGTON WOODS||BURLINGTON|MA|01803||Lithotriptor, extracorporeal shock-wave,urological|TECHNOMED INTERNATIONAL SONOLITH 3000|LNS|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|03/08/1994|04/18/1994|||APRL|
P880013|S001|NELLCOR PURITAN BENNETT, INC.|2200 FARADAY AVE.||CARLSBAD|CA|92008|7208|VENTILATOR, HIGH FREQUENCY|HFV STAR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/1992|02/05/1993|||APPR|
P880013|S002|NELLCOR PURITAN BENNETT, INC.|2200 FARADAY AVE.||CARLSBAD|CA|92008|7208|VENTILATOR, HIGH FREQUENCY|HFV STAR   (NEW MANUFACTURING SITE)|LSZ|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/1992|08/11/1993|||APPR|
P880013|S003|NELLCOR PURITAN BENNETT, INC.|2200 FARADAY AVE.||CARLSBAD|CA|92008|7208|VENTILATOR, HIGH FREQUENCY|HFV STAR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/1993|10/26/1993|||APPR|
P880016|S001|ONCOR, INC.|209 PERRY PKWY.||GAITHERSBURG|MD|20877||Dna-probe, b and t lymphocyte|ONCOR B/T GENE REARRANGEMENT TEST|MAM|HE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/1989|04/24/1990|||APPR|
P880016|S002|ONCOR, INC.|209 PERRY PKWY.||GAITHERSBURG|MD|20877||Dna-probe, b and t lymphocyte|ONCOR B/T GENE REARRANGEMENT TEST|MAM|HE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/1990|04/24/1990|||APPR|
P880016|S003|ONCOR, INC.|209 PERRY PKWY.||GAITHERSBURG|MD|20877||Dna-probe, b and t lymphocyte|ONCOR B/T GENE REARRANGEMENT TEST|MAM|HE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/07/1991|01/23/1992|||APPR|
P880016|S004|ONCOR, INC.|209 PERRY PKWY.||GAITHERSBURG|MD|20877||Dna-probe, b and t lymphocyte|ONCOR B/T GENE REARRANGEMENT TEST|MAM|HE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/26/1992|01/13/1993|||APPR|
P880024|S002|THE LAGADO CORP.|2890 SOUTH TEJON ST.||ENGLEWOOD|CO|80110||Lens, contact (other material) - daily|N-18 (KOLFOCON A),N-32 (KOLFOCON B)  LENS MATERIAL|HQD|OP|Normal 180 Day Track|Other Report|N|03/05/1993|02/24/1994|||APPR|
P880024|S003|THE LAGADO CORP.|2890 SOUTH TEJON ST.||ENGLEWOOD|CO|80110||Lens, contact (other material) - daily|N-18 (KOLFOCON A),N-32 (KOLFOCON B)  LENS MATERIAL|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/1993|03/04/1994|||APPR|
P880025|S001|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED|DURALOC(TM) 300S ACETABULAR CUP WITH POROCOAT(TM)|LPH|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/1990|02/08/1991|||APPR|
P880025|S002|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED|AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS|LPH|OR|Normal 180 Day Track|Other Report|N|08/21/1990|10/12/1990|||APPR|
P880025|S003|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED|AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS|LPH|OR|Normal 180 Day Track||N|07/08/1991|12/04/1991|||APPR|
P880027|S001|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC TM (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/19/1989|06/23/1989|||APPR|
P880027|S002|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC TM (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/1989|09/13/1989|||APPR|
P880027|S003|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC TM (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/27/1989|05/25/1990|||APPR|
P880027|S004|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC TM (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/1989|06/11/1990|||APPR|
P880027|S005|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC TM (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/1989|08/10/1990|||APPR|
P880027|S006|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MODELS P15-020,15-025,15-030,15-035, & P15-040|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/1990|09/10/1990|||APPR|
P880027|S007|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC (R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/26/1990|08/29/1990|||APPR|
P880027|S008|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC (R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/1990|09/27/1990|||APPR|
P880027|S009|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|MICROSOFTRAC (R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1990|01/18/1991|||APPR|
P880027|S010|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MAGNUM-MEIER(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/1990|01/18/1991|||APPR|
P880027|S011|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MICROSOFTRAC/MONORAIL PICCOLINO|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/1990|04/03/1991|||APPR|
P880027|S012|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1990|05/16/1991|||APPR|
P880027|S013|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/1991|03/26/1991|||APPR|
P880027|S014|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER XLP(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/1991|08/06/1991|||APPR|
P880027|S015|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/1991|05/21/1991|||APPR|
P880027|S016|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1991|05/21/1991|||APPR|
P880027|S017|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MONORAIL PICCOLINO(R) FORTE PTCA CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/1991|01/24/1992|||APPR|
P880027|S018|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MONORAIL PICCOLINO(R) FORTE PTCA CATH.|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/22/1991|06/13/1991|||APPR|
P880027|S019|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MAGNARAIL (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1991|01/30/1992|||APPR|
P880027|S020|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MICROSOFTRAC(R) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/03/1991|01/24/1992|||APPR|
P880027|S021|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER XLP(TM)30 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1991|01/24/1992|||APPR|
P880027|S022|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MONGOOSE(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/1992|10/29/1992|||APPR|
P880027|S023|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER XLP & PICCOLINO PTCA CATHETER CHANGES|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1992|12/30/1992|||APPR|
P880027|S024|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MYSTIC (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/29/1992|03/23/1993|||APPR|
P880027|S025|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/1992|02/12/1993|||APPR|
P880027|S026|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/04/1993|08/12/1993|||APPR|
P880027|S027|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER FREEHAND (TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1993|09/23/1993|||APPR|
P880027|S028|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MC RAIL(TM) 20,30,40 SLIDING RAIL PTCA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/1993|04/29/1994|||APPR|
P880027|S029|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER FREEHAND(TM) MODELS FH20-20,25,30,35,40|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1993|12/07/1993|||APPR|
P880027|S030|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MYSTIC(TM) 20,30,40 MC PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1993|05/17/1994|||APPR|
P880027|S031|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER FREEHAND(TM) & MC RAIL PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/1994|03/24/1995|||APPR|
P880027|S032|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER FREEFLIGHT(TM) PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1994|03/23/1995|||APPR|
P880027|S033|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER FREEHAND(R) PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1994|03/24/1995|||APPR|
P880028|S001|Hospira, Inc.|275 NORTH FIELD DR.|DEPT. 389, BLDG. H2-2|LAKE FOREST|IL|60045||FLUID, HYSTEROSCOPY|DEXTRAN HM 32|LTA|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1989|12/29/1989|||APPR|
P880028|S002|Hospira, Inc.|275 NORTH FIELD DR.|DEPT. 389, BLDG. H2-2|LAKE FOREST|IL|60045||FLUID, HYSTEROSCOPY|DEXTRAN HM 32|LTA|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/1990|11/15/1990|||APPR|
P880029|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/10/1988|03/13/1989|||APPR|
P880029|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/1988|10/28/1988|||APPR|
P880029|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/23/1989|02/21/1989|||APPR|
P880029|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|02/01/1990|||APPR|
P880029|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|02/01/1990|||APPR|
P880029|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/18/1989|01/31/1990|||APPR|
P880029|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Other Report|N|08/23/1990|11/19/1990|||APPR|
P880029|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|12/04/1991|||APPR|
P880029|S009|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|B AND L 70 LIDOFILCON A  CONTACT LENSE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1990|12/04/1991|||APPR|
P880029|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB FW TORIC (LIDOFILCON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/15/1990|02/12/1991|||APPR|
P880029|S013|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB FW TORIC (LIDOFILCON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/1991|10/30/1991|||APPR|
P880029|S014|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB MEDALIST TORIC (LIDOFILCON A) LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1991|02/14/1992|||APPR|
P880031|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|VITRAX OPHTHALMIC SURGICAL AID|LZP|OP|Normal 180 Day Track|Other Report|N|06/12/1991|02/10/1992|||APPR|
P880031|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|VITRAX OPHTHALMIC SURGICAL AID|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/1992|01/10/1994|||APPR|
P880031|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|VITRAX OPHTHALMIC SURGICAL AID|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1992|01/10/1994|||APPR|
P880031|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|VITRAX OPHTHALMIC SURGICAL AID|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/1992|01/10/1994|||APPR|
P880031|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|AMO(R) VITRAX(R) VISCOELASTIC SOLUTION|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1994|07/11/1994|||APPR|
P880032|S001|Bio-Rad|4000 ALFRED NOBEL DR.||HERCULES|CA|94547|1803|HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE|BIO-RAD CYCLOSPORINE BY HPLC TEST|MGS|CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/06/1990|03/14/1991|||APPR|
P880032|S002|Bio-Rad|4000 ALFRED NOBEL DR.||HERCULES|CA|94547|1803|HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE|BIO-RAD CYCLOSPORINE BY HPLC TEST|MGS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/1993|03/01/1996|||APPR|CHANGE IN MANUFACTURER SITE OF THE ANALYTICAL CARTRIDGE FROM THE LIFE SCIENCE GROUP OF BIO-RAD LABORATORIES LOCATED IN RICHMOND, CA TO THE CLINICAL SYSTEMS DIVISION OF THE DIAGNOSTICS GROUP OF BIO-RAD LABORATORIES LOCATED IN HERCULES, CA., AND CHANGING THE VENDOR OF THE "CLEAN UP" COLUMNS FOR THE CYCLOSPORIN TEST BY HPLC
P880035|S001|VISTA OPTICS, LTD.|10-12 LARKSTORE PARK, LODGE|ROAD,|STAPLEHURST, KENT||TN 12||Lens, contact (other material) - daily|OPTACRYL RIGID GAS PERMEABLE CONTACT LENS MATERIAL|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/1991|02/20/1992|||APPR|
P880035|S002|VISTA OPTICS, LTD.|10-12 LARKSTORE PARK, LODGE|ROAD,|STAPLEHURST, KENT||TN 12||Lens, contact (other material) - daily|VISTACRYL 18(KOLFOCON A) 32(KOFOCON B) RGP LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/1992|05/19/1993|||APPR|
P880035|S006|VISTA OPTICS, LTD.|10-12 LARKSTORE PARK, LODGE|ROAD,|STAPLEHURST, KENT||TN 12||Lens, contact (other material) - daily|VISTACRYL 18(KOLFOCON A) 32(KOLFOCON B) RGP LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/1993|08/11/1993|||APPR|
P880038|S001|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META-MV,PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/1989|05/10/1989|||APPR|
P880038|S002|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META-MV,PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/1989|07/27/1989|||APPR|
P880038|S003|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META-MV,PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/1989|01/23/1990|||APPR|
P880038|S004|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META-MV,PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/13/1989|09/14/1989|||APPR|
P880038|S005|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META-MV,PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/1989|10/16/1989|||APPR|
P880038|S006|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META-MV,PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/1989|07/25/1990|||APPR|
P880038|S008|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META DDD MODEL 1230 PACER|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1989|03/22/1990|||APPR|
P880038|S010|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META DDD MODEL 1230 PACER|DXY|CV|Normal 180 Day Track|Other Report|N|01/16/1990|02/02/1990|||APPR|
P880038|S011|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META DDD MODEL 1230 PACER|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/1990|09/10/1990|||APPR|
P880038|S012|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META MV MODEL 1202 & 1202 PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1990|05/09/1990|||APPR|
P880038|S013|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META II MODEL 1204 CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1990|10/11/1991|||APPR|
P880038|S014|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META MV MODEL 1202 CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1990|10/15/1990|||APPR|
P880038|S015|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META MV MODEL 1202 CARDIAC PACING SYSTEM|DXY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/27/1990|09/19/1990|||APPR|
P880038|S016|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META MV MODEL 1202 CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1990|10/22/1990|||APPR|
P880038|S017|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META MV MODEL 1202 CARDIAC PACING SYSTEM|DXY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/1990|12/13/1990|||APPR|
P880038|S018|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META MV MODEL 1202 CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track||N|08/05/1991|12/09/1991|||APPR|
P880038|S019|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META II MODEL 1204 CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1991|01/21/1992|||APPR|
P880038|S020|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META III MODEL 1206,1206E,1206M PACING SYSTEMS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/30/1991|01/07/1993|||APPR|
P880038|S021|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META II  MODEL 1204H    CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/1992|02/28/1992|||APPR|
P880038|S022|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 9600 AUX.INSTRUMENTS INTERFACE CABLE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/1992|04/19/1993|||APPR|
P880038|S023|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 9600 VERSION SC.11 PERSONALITY MODULE SOFT|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1992|06/17/1993|||APPR|
P880038|S024|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MEDA-MV PACING SYSTEM|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/1993|04/19/1993|||APPR|
P880038|S025|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MEDA-MV PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1993|02/24/1994|||APPR|
P880038|S028|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MEDA-MV PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/1994|07/23/1996|||APPR|APPROVAL FOR A CHANGE IN STERILIZATION CONTRACTOR. THE PROPOSED STERILIZATION CONTRACTOR IS: GRIFFITH MICROSCIENCE, INC., 2973 OLYMPIC INDUSTRIAL DRIVE, SMYRNA, GEORGIA 30080-7322
P880041|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Lens, contact (other material) - daily|MODEL UV44B INTRAOCULAR LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/1990|05/08/1990|||APPR|
P880041|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Lens, contact (other material) - daily|VALIDATION/GETINGE ETHYLENE OXIDE STERILIZER|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1991|08/27/1991|||APPR|
P880042|S001|EDAP INTERNATIONAL CORP.|179 SIDNEY ST.||CAMBRIDGE|MA|02139||Lithotriptor, extracorporeal shock-wave,urological|EDAP LT.01 SHOCK WAVE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Other Report|N|02/14/1994|04/18/1994|||APPR|
P880047|S001|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED TC7  ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/1990|07/18/1990|||APPR|
P880047|S003|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/1993|01/18/1996|||APPR|ALTERNATE STERILIZATION SITE, AS WELL AS A NEW MANUFACTURING SITE FOR BULK ROLL OF INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
P880049|S001|EPCON LABORATORIES|5927 CROMO||EL PASO|TX|79912||Lenses, soft contact, daily wear|EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/1991|07/19/1991|||APPR|
P880049|S002|EPCON LABORATORIES|5927 CROMO||EL PASO|TX|79912||Lenses, soft contact, daily wear|EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/1991|07/23/1992|||APPR|
P880052|S001|Abbott Laboratories|625 CLEVELAND AVE.||COLUMBUS|OH|43215||Accessories, soft lens products|MURINE CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1989|07/10/1990|||APPR|
P880053|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ENZYME/ SURFACTANT TABLET|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/1989|10/16/1989|||APPR|
P880053|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ENZYME/ SURFACTANT TABLET|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/11/1989|11/17/1989|||APPR|
P880053|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ENZYME/ SURFACTANT TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/1989|08/15/1990|||APPR|
P880053|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ENZYME/ SURFACTANT TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1990|12/19/1990|||APPR|
P880053|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ENZYME/ SURFACTANT TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/1990|02/09/1993|||APPR|
P880053|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|RGP DAILY CLEANING TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/1991|05/21/1992|||APPR|
P880055|S002|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MICROSS-SL(TM) PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1990|03/28/1991|||APPR|
P880055|S003|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MICROSS-SL(TM) PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/1991|07/19/1991|||APPR|
P880056|S001|Abbott Laboratories|625 CLEVELAND AVE.||COLUMBUS|OH|43215||Accessories, soft lens products|MURINER LUBRICATING & REWETTING DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/1989|10/13/1989|||APPR|
P880056|S002|Abbott Laboratories|625 CLEVELAND AVE.||COLUMBUS|OH|43215||Accessories, soft lens products|MURINE  LUBRICATING & REWETTING DROPS(CLEAR EYES )|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/1992|04/14/1994|||APPR|
P880062|S001|LABTHERMICS TECHNOLOGIES, INC.|701 DEVONSHIRE DR., BLDG. B-1||CHAMPAIGN|IL|61820||Applicator, hyperthermia, deep heating, ultrasound|SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM|LNB|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1990|08/23/1990|||APPR|
P880065|S001|Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||PULSE-GENERATOR, PROGRAM MODULE|MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER|LOT|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/29/1990|12/10/1990|||APPR|
P880070|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/1989|03/20/1990|||APPR|
P880070|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/1990|05/08/1990|||APPR|
P880070|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|VALIDATION/GETINGE ETHYLENE OXIDE STERILIZER|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1991|08/27/1991|||APPR|
P880070|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL UV65 SERIES ANTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/1992|01/23/1995|||APPR|
P880070|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL UV65 SERIES ANTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1992|10/17/1994|||APPR|
P880072|S001|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODEL  P12 MODEIFIED C LOOP W/NOTCH POSTERIOR CHAM|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1988|10/23/1989|||APPR|
P880072|S003|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODEL  P13 MODEIFIED C LOOP POSTERIOR CHAMBER|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1988|10/23/1989|||APPR|
P880072|S005|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1988|10/23/1989|||APPR|
P880072|S007|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|ASSORTED MOD. C LOOPS|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|12/19/1988|09/27/1989|||APPR|
P880072|S008|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|ASSORTED MOD. C LOOPS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/1989|12/01/1989|||APPR|
P880072|S010|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/1990|02/22/1990|||APPR|
P880072|S011|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/1990|02/22/1990|||APPR|
P880072|S012|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/1990|02/22/1990|||APPR|
P880072|S014|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Other Report|N|05/15/1990|07/13/1990|||APPR|
P880072|S015|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Other Report|N|05/15/1990|07/13/1990|||APPR|
P880072|S016|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Other Report|N|05/15/1990|07/13/1990|||APPR|
P880072|S018|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/1990|06/04/1991|||APPR|
P880072|S019|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP POSTERIOR CHAMBER SINGLE PIECE|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/1991|01/17/1992|||APPR|
P880072|S021|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODELS PA15,30,35,36,48,58|HQL|OP|Normal 180 Day Track|Other Report|N|04/15/1992|07/28/1995|||APPR|
P880076|S001|DOW CORNING WRIGHT|5677 AIRLINE RD.|P.O. BOX 100|ARLINGTON|TN|38002||PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED|WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS|LPH|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1990|06/17/1991|||APPR|
P880078|S001|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VOL. HYPERTHERMIA TREATMENT SYSTEM MODAL VH8500|LMZ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/1990|09/20/1991|||APPR|
P880078|S002|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500|LMZ|RA|Normal 180 Day Track|Other Report|N|06/12/1990|05/02/1991|||APPR|
P880078|S004|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500|LMZ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/1990|10/17/1990|||APPR|
P880078|S005|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500|LMZ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/1990|10/28/1991|||APPR|
P880078|S006|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500|LMZ|RA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/1991|02/25/1992|||APPR|
P880078|S007|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VH8500 HYPERTHERMIA TREATMENT SYSTEM|LMZ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/1992|05/21/1992|||APPR|
P880078|S008|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VH8500 HYPERTHERMIA TREATMENT SYSTEM|LMZ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/1992|05/21/1992|||APPR|
P880078|S009|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VH8500 HYPERTHERMIA TREATMENT SYSTEM|LMZ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/1992|08/31/1992|||APPR|
P880078|S010|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VH8500 HYPERTHERMIA TREATMENT SYSTEM|LMZ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/1992|05/21/1993|||APPR|
P880078|S011|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||Applicator, hyperthermia, interstitial|VH8500 HYPERTHERMIA TREATMENT SYSTEM|LMZ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1993|01/26/1994|||APPR|
P880079|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/1988|06/25/1990|||APPR|
P880079|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/1989|06/26/1990|||APPR|
P880079|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/1989|08/11/1989|||APPR|
P880079|S005|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|9IBA VISION(R) STERILE BUFFERED AEROSOL SALINE|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/1989|09/14/1989|||APPR|
P880079|S007|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|9IBA VISION(R) STERILE BUFFERED AEROSOL SALINE|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/1989|10/13/1989|||APPR|
P880079|S008|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/1989|04/11/1990|||APPR|
P880079|S010|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/1991|07/15/1991|||APPR|
P880079|S011|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/1991|12/03/1991|||APPR|
P880079|S012|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|SOFTWARE(R) PLUS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/14/1993|09/09/1994|||APPR|
P880080|S001|STERIDYNE LABORATORIES, INC.|22 HILLWOOD RD.||EAST BRUNSWICK|NJ|08816||Accessories, soft lens products|DYNASOL (R) PRESERVATIVE-FREE SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/01/1989|08/28/1989|||APPR|
P880080|S002|STERIDYNE LABORATORIES, INC.|22 HILLWOOD RD.||EAST BRUNSWICK|NJ|08816||Accessories, soft lens products|SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1989|04/19/1990|||APPR|
P880080|S004|STERIDYNE LABORATORIES, INC.|22 HILLWOOD RD.||EAST BRUNSWICK|NJ|08816||Accessories, soft lens products|DYNASOL 4|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/02/1991|06/20/1991|||APPR|
P880081|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|UV-ABSORBING SILICONE POSTERIOR CHAMBER INTROCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1989|09/14/1990|||APPR|
P880081|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL SI-19NB (PHACOFLEX)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1989|09/14/1990|||APPR|
P880081|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL SI-18NB (PHACOFLEX)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/1989|09/14/1990|||APPR|
P880081|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SILICON ELASTOMERIC POSTERIOR CHAMBER INTRAOCULAR|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/1990|09/11/1990|||APPR|
P880081|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SILICON ELASTOMERIC POSTERIOR CHAMBER INTRAOCULAR|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/1990|06/15/1990|||APPR|
P880081|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SILICON ELASTOMERIC POSTERIOR CHAMBER INTRAOCULAR|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/27/1989|02/21/1991|||APPR|
P880081|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODELS SS-25NB & SS-26NB SILICONE ELASTOMERIC POST|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/1990|01/14/1991|||APPR|
P880081|S009|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SILICONE ELASTOMERIC POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/1991|02/21/1991|||APPR|
P880081|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|PHACO-FLEX(TM) MODELS SI-18B & SI-18NB IOL|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/04/1992|09/19/1994|||APPR|
P880081|S012|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SLM-2 SILICONE UV-ABSORBING IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/1992|09/27/1994|||APPR|
P880081|S013|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SI-18B/SI-18NB UV-ABSORBING SILICONE POSTERIOR IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1992|11/09/1992|||APPR|
P880081|S014|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SI-18B/SI-18NB UV-ABSORBING SILICONE POSTERIOR IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1992|11/09/1992|||APPR|
P880081|S017|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/1993|01/18/1995|||APPR|
P880082|S002|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/1989|06/26/1990|||APPR|
P880082|S003|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1989|09/14/1990|||APPR|
P880082|S005|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|MODEL 24070 UV ABSORBING POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1990|09/11/1990|||APPR|
P880082|S007|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|MODEL 14660 UV ABSORBING POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1990|06/28/1990|||APPR|
P880082|S008|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|MODEL 13060 UV ABSORBING POSTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1990|06/28/1990|||APPR|
P880082|S009|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|THREE & SINGLE PIECE BIOCONVEX INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1990|07/23/1991|||APPR|
P880082|S011|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/1991|05/01/1991|||APPR|
P880082|S012|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|TIER A MODELS 24050,24150,25050,25350-125 LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/1991|09/04/1991|||APPR|
P880082|S013|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|TIER A MODELS 24050,24150,25050,25350-125 LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/24/1991|08/06/1991|||APPR|
P880082|S014|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|MODIFIED LABELING FOR IOL 60 MOS.STERILITY EXPIR.|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1992|05/15/1992|||APPR|
P880082|S017|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/03/1994|10/04/1994|||APPR|
P880086|S001|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3003 PROGRAMMER MODEL 3036B FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1989|05/04/1990|||APPR|
P880086|S002|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY MODEL 2020T PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1989|09/18/1989|||APPR|
P880086|S003|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3033C FUNCTION PACT|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1989|05/04/1990|||APPR|
P880086|S004|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY II MODELS 2022T & 2023M - 2002T & 2003M|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1989|06/13/1990|||APPR|
P880086|S005|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY II MODELS 2022T & 2023M - 2002T & 2003M|DXY|CV|Normal 180 Day Track|Other Report|N|11/13/1989|01/18/1990|||APPR|
P880086|S006|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY MODEL 2020T CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/1990|12/18/1990|||APPR|
P880086|S007|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1990|02/13/1991|||APPR|
P880086|S008|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/29/1990|01/31/1991|||APPR|
P880086|S009|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1990|06/26/1991|||APPR|
P880086|S010|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/1991|01/11/1993|||APPR|APPROVAL FOR RELOCATING THE MANUFACTURING FACILITIES TO 15900 VALLEYVIEW COURT, SYLMAR, CALIFORNIA, 91392-9221
P880086|S011|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APS-11 MODEL 3003 PROGRAMMER|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/1991|09/16/1991|||APPR|
P880086|S012|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3037A FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/1991|12/24/1991|||APPR|
P880086|S013|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SOLUS 2002,2003 & SYNCHRONY II 2022,2023 PULSE GEN|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1991|08/19/1991|||APPR|
P880086|S014|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG 2020T, SESOLOG II 2022T, SOLUS 200T|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/1991|09/16/1991|||APPR|
P880086|S015|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3038 FUNCTION PACK FOR APS-II 3003 PROGRAMME|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1991|04/14/1992|||APPR|
P880086|S016|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SOLUS(R) II MODELS 2006L,2006T,2007K,2007M/S PULSE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/1992|02/05/1993|||APPR|
P880086|S017|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R)MODEL 2020T PULSE GEN.,& 3000 PROGRAMM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1992|02/05/1993|||APPR|
P880086|S018|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R)ALTERNATE PRODUCT TRAY|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1992|11/18/1992|||APPR|
P880086|S020|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R) SOFTWARE CHANGE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/22/1992|08/11/1992|||APPR|
P880086|S021|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SOLUS (R) MODELS 2002,2003,SYNCHRONY(R)2022,2023|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/1993|06/04/1993|||APPR|
P880086|S022|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY MODELS PARAGON III/PHOENIX III PACERS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1993|10/17/1994|||APPR|
P880086|S023|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY PACING SYS. MODEL 385 FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/1993|07/12/1994|||APPR|
P880086|S024|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY PACING SYS. MODEL 3039 FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/1993|07/12/1994|||APPR|
P880086|S025|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/1993|08/30/1994|||APPR|
P880086|S026|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1993|10/31/1994|||APPR|
P880086|S027|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/1993|09/27/1994|||APPR|
P880086|S028|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/14/1994|06/07/1995|||APPR|
P880086|S029|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1994|03/27/1995|||APPR|
P880086|S030|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/1994|01/23/1995|||APPR|
P880087|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MTA1 THROUGH MTA7 & MTA1U THROUGH MTA7U|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/1990|05/22/1990|||APPR|
P880087|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/1991|12/20/1991|||APPR|
P880090|S001|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1988|07/03/1990|||APPR|
P880090|S002|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1988|06/27/1990|||APPR|
P880090|S003|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1990|11/15/1990|||APPR|
P880090|S004|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Other Report|N|06/06/1990|11/15/1990|||APPR|
P880090|S005|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL 121UV ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/10/1990|09/28/1990|||APPR|
P880090|S006|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/1990|10/24/1990|||APPR|
P880090|S007|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|STORZ IOL DISTRIBUTE/OPTICAL RADIATION|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/08/1991|08/11/1993|||APPR|
P880090|S008|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODELS 121UV & S121UV ULTRAVIOLET-ABSORBING LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/15/1991|08/11/1993|||APPR|
P880090|S009|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODELS 121UV & S121UV ULTRAVIOLET-ABSORBING LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/10/1992|06/21/1994|||APPR|
P880090|S010|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODELS 121UV & S121UV ULTRAVIOLET-ABSORBING LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/1992|05/22/1995|||APPR|
P880090|S011|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Other Report|N|09/14/1992|08/09/1994|||APPR|
P880090|S012|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 120UV|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/29/1992|03/31/1995|||APPR|
P880090|S013|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 120UV|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1993|06/27/1994|||APPR|
P880090|S014|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1993|11/29/1994|||APPR|
P880090|S015|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/1994|07/29/1994|||APPR|
P880090|S016|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1994|02/08/1995|||APPR|
P880091|S002|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/1992|04/03/1995|||APPR|
P880091|S003|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|MODEL AA-4203F SINGLE PIECE IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/1992|07/29/1994|||APPR|
P880091|S004|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIC LENS(TM) AA-4203 & CHIROFLEX(TM) 32-C10XX|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/1992|08/30/1994|||APPR|
P880098|S001|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, daily wear|MENICON SF-P RGP (MELAFOCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1989|02/08/1990|90M-0068|03/08/1990|APPR|
P880098|S002|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, daily wear|MENICON SF-P RGP (MELAFOCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/1989|11/02/1989|||APPR|
P880098|S003|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, daily wear|MENICON SF-P RGP (MELAFOCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/1989|05/03/1990|||APPR|
P880098|S004|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, daily wear|MENICON SF-P RGP (MELAFOCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/1990|09/21/1990|||APPR|
P880098|S005|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, daily wear|MENICON SUPER EX CONTACT LENS|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/08/1991|08/25/1992|||APPR|
P880098|S006|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, daily wear|MENICON SUPER EX CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1993|03/23/1993|||APPR|
P880101|S002|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|AQUAFLEX[TETRAFILCON A] CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/1989|08/29/1990|||APPR|
P880101|S003|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/1989|03/05/1990|||APPR|
P880101|S004|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE|LPL|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/1989|09/14/1990|90M-0317|11/02/1990|APPR|
P880101|S005|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/1991|12/03/1991|||APPR|
P880101|S006|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, daily wear|AQUAFLEX DAILY & EXTENDED WEAR HYDROPHILIC LENS|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|05/03/1994|06/13/1994|||APPR|
P880102|S001|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, daily wear|LOMBART (POLYMACON) SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/1991|03/05/1992|||APPR|
P880102|S002|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, daily wear|LOMBART (POLYMACON)POLYMER BUTTONS & LATHE LL-38L|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/1991|05/05/1993|||APPR|
P890001|S001|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR,INC. MODELS 7.5S|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/1990|12/20/1990|||APPR|
P890001|S002|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR,INC. CORFLO(TM) MODEL 7.5S PTCA CATHETERS|LOX|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/17/1990|02/15/1994|94M-0065||APPR|
P890001|S003|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR,INC. PICOCATH CATHETER 2,2.5,3,3.5, BALLOON|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/14/1990|03/08/1991|||APPR|
P890001|S004|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR CORFLO(TM) MODEL 7.5PT PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1990|06/12/1991|||APPR|
P890001|S005|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR PICOCATH(TM) MODEL PICO-ST|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/1991|05/04/1993|||APPR|
P890001|S006|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR PICOCATH(TM) MODEL PICO-ST|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/1991|10/25/1991|||APPR|
P890001|S007|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR CORFLO(TM) MODEL 7.1PT (COATED)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1991|05/04/1993|||APPR|
P890001|S009|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR PICO RUNNER CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/16/1993|07/28/1994|||APPR|
P890001|S010|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/1993|08/04/1994|||APPR|
P890001|S011|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1994|06/13/1996|||APPR|APPROVAL FOR CHANGES IN THE INSTRUCTIONS FOR USE, THE ADDITION OF A PUMP HEAD WITH LONGER TUBING, A CHANGE IN THE CLEANING PROCESS, AND THE ADDITION OF STOPCOCKS ON THE PUMPS
P890003|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SYSNERGYST II PULSE GENERATOR MODELS 7070 & 7071|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/1989|01/04/1990|||APPR|
P890003|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SYSNERGYST II PULSE GENERATOR MODELS 7070 & 7071|DXY|CV|Normal 180 Day Track|Other Report|N|11/30/1989|01/18/1990|||APPR|
P890003|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC ELITE(TM) MODELS 7074,7075,7076,& 7077|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1990|04/24/1991|||APPR|
P890003|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/1990|12/18/1990|||APPR|
P890003|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC SYNERGYST II MODEL 7070 PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1990|12/27/1990|||APPR|
P890003|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SYNERGYST(TM) II MODELS 7070/7071 (M) (A)|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/1991|07/26/1991|||APPR|
P890003|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9760 PROGRAMMING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/1991|12/29/1992|||APPR|
P890003|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9852 SOFTWARE SYSTEM|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/1991|08/19/1991|||APPR|
P890003|S009|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9855 SOFTWARE SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/1991|11/25/1991|||APPR|
P890003|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODELS 7070,7071,7071M,SYNERGEST(TM)II PULSE GEN|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1991|12/18/1991|||APPR|
P890003|S011|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODELS 7107,7108 MINUET PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1991|03/20/1992|||APPR|
P890003|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9760 PROGRAMMING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/1991|04/03/1992|||APPR|
P890003|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 7074, 7075 AND 7077 ELITE(TM) PULSE GENERATO|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/22/1991|02/28/1992|||APPR|
P890003|S014|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 7074, 7075 AND 7077 ELITE(TM) PULSE GENERATO|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/26/1992|04/10/1992|||APPR|
P890003|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|ELITE & PRELUDE DR PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/1992|05/04/1992|||APPR|
P890003|S016|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC (R) ELITE II PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/1992|12/04/1992|||APPR|
P890003|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 9855 SOFTWARE CHANGE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1992|08/18/1992|||APPR|
P890003|S018|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODELS ELITE,MINUET,& PRELUDE DR MODIF.|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/1992|11/05/1992|||APPR|
P890003|S019|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 9858 SOFTWARE DISKETTES|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1992|02/19/1993|||APPR|
P890003|S020|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 9858 A SOFTWARE DISKETTES|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/1992|06/03/1993|||APPR|
P890003|S021|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC ELITE II MODEL 7086|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1993|11/08/1993|||APPR|
P890003|S022|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC SYNERGYST II PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/1993|01/26/1994|||APPR|
P890003|S023|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 5424 ELECTROCARDIOGRAM CABLE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1993|08/10/1993|||APPR|
P890003|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC ELITE II(TM) PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1993|04/29/1994|||APPR|
P890003|S025|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC DUAL CHAMBER PACEMAKERS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/1994|01/31/1995|||APPR|
P890003|S027|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) SYNERGYST II|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1994|11/29/1994|||APPR|
P890003|S028|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) MODEL 9870A SOFTWARE DISKETTES|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/16/1994|01/11/1995|||APPR|
P890003|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC DUAL CHAMBER PACEMAKERS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1994|10/06/1994|||APPR|
P890003|S030|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC DUAL CHAMBER PACEMAKERS|DXY|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/1994|09/06/1994|||APPR|
P890003|S031|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(TM) PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/23/1994|01/10/1995|||APPR|
P890003|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(TM) PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1994|03/01/1995|||APPR|
P890003|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(TM) PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/1994|01/05/1995|||APPR|
P890012|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|8IGNATURE CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/1989|06/14/1990|||APPR|
P890012|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|8IGNATURE CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/1990|05/28/1991|||APPR|
P890012|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|8IGNATURE CONTACT LENS|LPM|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/1994|11/09/1994|||APPR|
P890014|S001|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|ETI-HA-IGMK|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1990|09/16/1991|||APPR|
P890017|S002|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|JJIS PALMAZ(TM) BALLOON-EXPANDABLE STENT|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1992|12/11/1992|||APPR|
P890017|S004|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLOON-EXPANDABLE STENT/ILIAC ARTERIES|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/1994|05/20/1996|||APPR|ALTERNATE MANUFACTURING FACILITY FOR FINISHING, PACKAGING, AND DISTRIBUTION OF THE DEVICE
P890019|S001|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|ETI-AB-HAVK|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/1990|03/01/1991|||APPR|
P890020|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens, contact (polymethylmethacrylate)|FLUOROCON TM-60|HPX|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/29/1989|12/28/1990|91M-0013|12/28/1990|APPR|
P890020|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lens,contact(rigid gas permeable)-extended wear|FLUOROCON TM-60|MWL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/1990|09/18/1990|||APPR|
P890023|S001|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|H55 HYDROPHILIC CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/1990|09/10/1991|||APPR|
P890023|S002|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|H55 HYDROPHILIC CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/1993|08/15/1994|||APPR|
P890024|S001|SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.|15 KIT ST.||KEENE|NH|03431||CATHETER, SAMPLING, CHORIONIC VILLUS|TROPHOCAN TM|LLX|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/14/1990|08/17/1990|||APPR|
P890024|S002|SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.|15 KIT ST.||KEENE|NH|03431||CATHETER, SAMPLING, CHORIONIC VILLUS|TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER|LLX|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1990|02/25/1992|||APPR|
P890024|S003|SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.|15 KIT ST.||KEENE|NH|03431||CATHETER, SAMPLING, CHORIONIC VILLUS|TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER|LLX|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/1991|04/21/1992|||APPR|
P890024|S004|SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.|15 KIT ST.||KEENE|NH|03431||CATHETER, SAMPLING, CHORIONIC VILLUS|TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER|LLX|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/1991|04/21/1992|||APPR|
P890024|S005|SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.|15 KIT ST.||KEENE|NH|03431||CATHETER, SAMPLING, CHORIONIC VILLUS|TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER|LLX|OB|Normal 180 Day Track|Other Report|N|05/04/1992|12/27/1993|||APPR|
P890025|S001|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUM ASSAY|MGU|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1990|05/04/1990|||APPR|
P890025|S002|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES WHOLE BLOOD ASSAY|MGU|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/1990|10/04/1990|||APPR|
P890025|S003|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY|MGU|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/1991|03/18/1992|||APPR|
P890025|S004|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY|MGU|TX|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/1992|12/17/1992|||APPR|
P890025|S005|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY|MGU|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1992|12/17/1992|||APPR|
P890025|S006|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY|MGU|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1992|12/15/1992|||APPR|
P890025|S007|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY|MGU|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1992|12/15/1992|||APPR|
P890025|S008|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY|MGU|TX|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1993|03/31/1994|||APPR|
P890027|S001|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL|MCM|EN|Normal 180 Day Track|Other Report|N|01/08/1991|09/10/1991|||APPR|
P890027|S002|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1991|05/16/1991|||APPR|
P890027|S003|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/1991|08/15/1991|||APPR|
P890027|S004|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/1991|08/15/1991|||APPR|
P890027|S005|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/1991|03/09/1994|||APPR|
P890027|S006|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS MINI 22 IMPLANT -OMIT ULTRASONIC WELD|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/1991|05/20/1993|||APPR|
P890027|S007|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|IF4 BOARD FOR THE DUAL PROCESSOR INTERFACE SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1991|09/14/1992|||APPR|
P890027|S008|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|LAPEL MICROPHONE MODIFICATION|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/1991|05/29/1992|||APPR|
P890027|S009|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|COCHLEAR'S MINI 22 COCHLEAR IMPLANT (MODEL CI22M)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/1992|04/05/1993|||APPR|
P890027|S010|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|MAGNET OPTION (Z11020)  IMPLANT MODEL CI22C|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1992|05/20/1993|||APPR|
P890027|S011|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/1992|07/07/1992|||APPR|
P890027|S012|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/1992|07/07/1992|||APPR|
P890027|S013|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1992|07/07/1992|||APPR|
P890027|S014|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1992|07/07/1992|||APPR|
P890027|S015|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMP DPS SOFTWARE|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1992|02/26/1993|||APPR|
P890027|S016|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/1992|03/09/1994|||APPR|
P890027|S017|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/08/1992|03/19/1993|||APPR|
P890027|S018|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|MINI SPEECH PROCESSOR|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/1993|04/28/1994|||APPR|
P890027|S019|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/07/1993|03/30/1994|||APPR|
P890027|S020|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1993|03/09/1994|||APPR|
P890027|S021|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1993|03/09/1994|||APPR|
P890027|S022|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/06/1994|09/27/1994|||APPR|
P890027|S023|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/1994|05/15/1995|||APPR|
P890027|S025|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1994|02/13/1996|||APPR|APPROVAL FOR COMPONENT AND PROCESS CHANGES TO THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE COMPONENT CHANGE CONSISTS OF REPLACING THE LOWER VALUE NPO DIELECTRIC TRIM CAPACITOR WITH THE SAME BX DIELECTRIC MATERIAL AS USED FOR THE HIGHER VALUE TRIM CAPACITOR. THE PROCESS CHANGE CONSISTS OF PREHEATING THE CAPACITORS AND PRINTED CIRCUIT BOARD PRIOR TO SOLDERING THE CAPACITORS TO THE PCB
P890029|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|EXCELENS (ATLAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1989|03/06/1990|||APPR|
P890029|S002|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|EXCELENS (ATLAFILCON A) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1990|08/02/1993|||APPR|
P890029|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Lenses, soft contact, daily wear|CIBA 2000(TM) (ATLAFILCON A) SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1990|09/11/1992|92M-0390|05/03/1993|APPR|
P890031|S001|OCULAR TECHNOLOGIES, INC.|3803B COMPUTER DR.||RALEIGH|NC|27609||Lenses, soft contact, daily wear|OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/1989|03/06/1991|||APPR|
P890031|S002|OCULAR TECHNOLOGIES, INC.|3803B COMPUTER DR.||RALEIGH|NC|27609||Lenses, soft contact, daily wear|OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/1989|11/15/1990|||APPR|
P890031|S003|OCULAR TECHNOLOGIES, INC.|3803B COMPUTER DR.||RALEIGH|NC|27609||Lenses, soft contact, daily wear|OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/1990|04/25/1991|||APPR|
P890032|S001|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|ANGIOPLASTY (PTCA) DILATATION CATHETERS|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/1990|04/30/1990|||APPR|
P890032|S002|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Other Report|N|03/28/1990|07/23/1992|||APPR|
P890032|S003|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1990|09/14/1990|||APPR|
P890032|S004|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/1990|11/08/1990|||APPR|
P890032|S006|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALL. CATH. 1.5 CM TIP|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/17/1990|08/15/1990|||APPR|
P890032|S007|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS 3.5 MM SOFT-WIRE ORION STEERABLE PTCA BALL.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1990|02/14/1992|||APPR|
P890032|S008|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION EXTENSION|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/1990|03/26/1991|||APPR|
P890032|S009|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1990|07/25/1991|||APPR|
P890032|S010|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1990|04/26/1991|||APPR|
P890032|S011|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/22/1991|10/04/1991|||APPR|
P890032|S012|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/1991|12/03/1991|||APPR|
P890032|S013|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1991|04/03/1992|||APPR|
P890032|S014|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION II STEERABLE BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/1992|06/17/1993|||APPR|
P890032|S015|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA CATH. W/GLISSADE HYDRO|LOX|CV|Special (Immediate Track)|Other Report|N|03/24/1992|06/22/1992|||APPR|
P890032|S016|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS 3.5MM SOFT-WIRE ORION STEERABLE PTCA CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1992|11/06/1992|||APPR|
P890032|S017|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/1993|04/28/1994|||APPR|
P890032|S018|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1993|08/04/1995|||APPR|APPROVAL FOR:ALTERNATE STERILIZATION SITE; ELIMINATION OF CHLOROFLUOROCARBONS FROM THE STERILIZATION PROCESS
P890034|S001|Covidien|6135 GUNBARREL AVE.||BOULDER|CO|80301||VENTILATOR, HIGH FREQUENCY|MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/12/1993|09/10/1993|||APPR|
P890034|S002|Covidien|6135 GUNBARREL AVE.||BOULDER|CO|80301||VENTILATOR, HIGH FREQUENCY|MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1993|03/28/1994|||APPR|
P890034|S003|Covidien|6135 GUNBARREL AVE.||BOULDER|CO|80301||VENTILATOR, HIGH FREQUENCY|MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/1993|06/17/1994|||APPR|
P890034|S004|Covidien|6135 GUNBARREL AVE.||BOULDER|CO|80301||VENTILATOR, HIGH FREQUENCY|MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/1993|06/14/1995|||APPR|
P890039|S001|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|POLYSAFE(TM) A-TRACK(TM) MODEL AT-332 ENDOCARDIAL|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/1990|01/21/1992|||APPR|
P890039|S002|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/1991|04/25/1991|||APPR|
P890039|S003|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1991|01/21/1992|||APPR|
P890039|S004|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/1991|10/04/1991|||APPR|
P890039|S005|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/1991|10/04/1991|||APPR|
P890039|S006|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/1992|09/14/1992|||APPR|
P890039|S007|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) SAVVI(TM) SERIES 305 VDD PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/1992|04/05/1993|||APPR|
P890039|S008|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|CCS MODEL 333 PACEMAKER SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/1992|06/24/1993|||APPR|
P890039|S009|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|CCS MODEL 333 PACEMAKER INTRO. 3 NEW MODELS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1992|08/03/1992|||APPR|
P890039|S010|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|CCS MODEL 300 PACEMAKER MAESTRO|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/1992|02/12/1993|||APPR|
P890039|S011|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|CCS MODEL 325 PACEMAKER SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/1993|08/26/1993|||APPR|APPROVAL FOR THE MAESTRO SAVVI MODEL 325 PULSE GENERATOR
P890039|S012|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|CCS MODEL 325 PACEMAKER SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1993|12/02/1994|||APPR|
P890039|S013|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1994|04/29/1994|||APPR|
P890040|S001|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/1989|11/28/1989|||APPR|
P890040|S002|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1990|04/24/1991|||APPR|
P890040|S003|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Other Report|N|02/11/1991|07/23/1991|||APPR|
P890040|S004|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1991|06/29/1992|||APPR|
P890043|S001|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/1990|12/19/1990|||APPR|
P890043|S002|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1990|12/19/1990|||APPR|
P890043|S003|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/09/1990|12/18/1990|||APPR|
P890043|S004|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/1990|06/12/1991|||APPR|
P890043|S005|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/29/1990|12/27/1990|||APPR|
P890043|S006|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/1990|03/19/1991|||APPR|
P890043|S007|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/1991|01/22/1991|||APPR|
P890043|S008|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/1991|02/21/1991|||APPR|
P890043|S009|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/1991|04/03/1991|||APPR|
P890043|S011|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM) SCA-LP(TM) DEVICE|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/1991|08/27/1991|||APPR|
P890043|S012|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(R) SCA-EX DEVICE|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1991|03/20/1992|||APPR|
P890043|S013|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/1991|02/11/1993|||APPR|
P890043|S014|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/1991|01/16/1992|||APPR|
P890043|S015|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/1991|12/07/1992|||APPR|
P890043|S016|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1992|01/12/1993|||APPR|
P890043|S017|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(R) (SCA(TM))|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/1992|05/04/1993|||APPR|
P890043|S020|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(R) (SCA(TM))DEV.MOD.|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/1992|05/23/1994|||APPR|
P890043|S021|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(R) (GTO)(TM) DEVICE|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/13/1993|01/12/1994|||APPR|
P890043|S022|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SCA-EX 7F GRAFT DEVICE|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/1993|04/13/1994|||APPR|
P890043|S025|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/1994|12/02/1994|||APPR|
P890043|S026|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/13/1994|01/31/1995|||APPR|
P890043|S027|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/1994|08/17/1995|||APPR|APPROVAL FOR REVISED PRODUCT LABELING FOR THE SCA-EX AND ATHEROCATH-GTO MODELS OF THE SIMPSON CORONARY ATHEROCATH
P890044|S001|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/1990|05/07/1990|||APPR|
P890044|S002|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/1990|05/08/1990|||APPR|
P890044|S003|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/1990|06/04/1990|||APPR|
P890044|S004|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/1990|06/25/1990|||APPR|
P890044|S005|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Special (Immediate Track)|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/1990|07/05/1990|||APPR|
P890044|S006|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/1990|07/23/1990|||APPR|
P890044|S007|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/1990|08/15/1990|||APPR|
P890044|S008|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1990|09/14/1990|||APPR|
P890044|S009|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/1990|10/25/1990|||APPR|
P890044|S010|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/1990|12/19/1990|||APPR|
P890044|S011|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|HYDROPERM (TM)  RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/13/1991|04/05/1991|||APPR|
P890044|S012|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|HYDROPERM (TM)  RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/1991|03/18/1991|||APPR|
P890044|S013|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|HYDROPERM (TM)  RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/1991|05/17/1991|||APPR|
P890044|S014|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|HYDROPERM (TM)  RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1991|07/08/1991|||APPR|
P890044|S015|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|HYDROPERM (TM)  RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/1991|07/19/1991|||APPR|
P890044|S016|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|HYDROPERM (TM)  RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/1991|09/19/1991|||APPR|
P890044|S017|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|HYDROPERM (TM)  RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/1991|10/23/1991|||APPR|
P890044|S018|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|HYDROPERM (TM)  RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1991|12/18/1991|||APPR|
P890044|S019|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|ADD RGP LENS FINISHING LABORATORIES.|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/1992|02/06/1992|||APPR|
P890044|S020|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|ADD RGP LENS FINISHING LABORATORIES.|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/1992|04/14/1992|||APPR|
P890044|S021|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|ADD RGP LENS FINISHING LABORATORIES.|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/1992|06/26/1992|||APPR|
P890044|S022|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|ADD RGP LENS FINISHING LABORATORIES.|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/1992|09/01/1992|||APPR|
P890044|S023|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|ADD RGP LENS FINISHING LABORATORIES.|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1992|09/30/1992|||APPR|
P890044|S024|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|ADD RGP LENS FINISHING LABORATORIES.|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/1992|02/05/1993|||APPR|
P890044|S025|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1993|02/09/1993|||APPR|
P890044|S026|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/1993|05/27/1993|||APPR|
P890044|S027|RAND SCIENTIFIC CORP.|4135 NORTHGATE BLVD., SUITE 9||SACRAMENTO|CA|95834||Lens, contact (other material) - daily|TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/1993|01/26/1994|||APPR|
P890045|S001|CARBOMEDICS, INC.|1300-D EAST ANDERSON LN.||AUSTIN|TX|78752||GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE|VASCUTEK GELSOFT(TM) VASCULAR GRAFT|MAL|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1993|07/05/1995|||APPR|APPLYING THE GELATIN COATING TO THE VASCUSOFT, A DIFFERENT SUBSTRATE GRAFT.THE MODIFIED DEVICE WILL BE MARKETED UNDER TRADE NAME:VASCUTEK GELSOFT VASCULAR GRAFT
P890045|S003|CARBOMEDICS, INC.|1300-D EAST ANDERSON LN.||AUSTIN|TX|78752||GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE|VASCUTEK GELSOFT(TM) VASCULAR GRAFT|MAL|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1993|12/07/1993|||APPR|
P890045|S005|CARBOMEDICS, INC.|1300-D EAST ANDERSON LN.||AUSTIN|TX|78752||GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE|VASCUTEK GELSEAL(TM) VASCULAR GRAFT|MAL|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1994|04/13/1995|||APPR|
P890045|S006|CARBOMEDICS, INC.|1300-D EAST ANDERSON LN.||AUSTIN|TX|78752||GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE|VASCUTEK GELSEAL(TM) VASCULAR GRAFT|MAL|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/1994|07/22/1994|||APPR|
P890046|S001|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/1990|09/10/1990|||APPR|
P890046|S002|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1990|09/10/1990|||APPR|
P890046|S003|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/1990|09/18/1990|||APPR|
P890046|S004|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/1990|10/24/1990|||APPR|
P890046|S005|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/1990|11/05/1990|||APPR|
P890046|S006|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Other Report|N|11/08/1990|12/19/1990|||APPR|
P890046|S007|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/1991|02/12/1991|||APPR|
P890046|S008|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/1991|04/22/1991|||APPR|
P890046|S009|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/1991|05/17/1991|||APPR|
P890046|S010|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/1991|06/04/1991|||APPR|
P890046|S011|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/1991|07/19/1991|||APPR|
P890046|S012|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1991|09/13/1991|||APPR|
P890046|S013|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1991|10/30/1991|||APPR|
P890046|S014|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/1991|12/18/1991|||APPR|
P890046|S015|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1992|02/06/1992|||APPR|
P890046|S016|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/1992|06/10/1992|||APPR|
P890046|S017|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS ADD FINISH LABS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1992|07/14/1992|||APPR|
P890046|S018|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS ADD FINISH LABS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/1992|12/04/1992|||APPR|
P890046|S019|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS ADD FINISH LABS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1992|01/14/1993|||APPR|
P890046|S020|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS ADD FINISH LABS|HQD|OP|Normal 180 Day Track|Other Report|N|05/21/1993|09/20/1993|||APPR|
P890046|S021|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|06/14/1993|09/20/1993|||APPR|
P890046|S022|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|06/29/1993|09/20/1993|||APPR|
P890046|S023|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/1993|09/30/1993|||APPR|
P890046|S024|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/1993|11/04/1993|||APPR|
P890046|S025|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/1993|01/13/1994|||APPR|
P890046|S026|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/1994|03/01/1994|||APPR|
P890046|S027|OPTICAL POLYMER RESEARCH, INC.|5921 N.E. 38TH ST.||GAINESVILLE|FL|32609||Lens, contact (other material) - daily|O-PERM F60 RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1994|03/01/1994|||APPR|
P890047|S001|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC TM VISCOELASTIC PREPARATION|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1992|07/20/1993|||APPR|
P890047|S002|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC TM VISCOELASTIC PREPARATION|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/28/1993|08/17/1994|||APPR|
P890047|S003|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC TM VISCOELASTIC PREPARATION|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/1994|06/22/1994|||APPR|
P890047|S004|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC TM VISCOELASTIC PREPARATION|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/1994|12/13/1994|||APPR|
P890048|S003|USCI, DIV. C.R. BARD, INC.|1200 TECHNOLOGY PARK DR.|P.O. BOX 7025|BILLERICA|MA|01821||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/1992|05/17/1995|||APPR|
P890049|S001|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, daily wear|FINISHED METHAFILCON A CONTACT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/1989|10/10/1989|||APPR|
P890049|S002|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, daily wear|FINISHED METHAFILCON A CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/1991|07/19/1991|||APPR|
P890049|S003|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, daily wear|FINISHED METHAFILCON A CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1993|07/06/1994|||APPR|
P890053|S001|N & N CONTACT LENS CO., LTD.|P.O. BOX 1035|19031 33RD AVE. WEST|LYNWOOD|WA|98046||Lenses, soft contact, daily wear|O.P.R. -55 SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1989|03/06/1990|||APPR|
P890053|S002|N & N CONTACT LENS CO., LTD.|P.O. BOX 1035|19031 33RD AVE. WEST|LYNWOOD|WA|98046||Lenses, soft contact, daily wear|O.P.R. -55 SOFT CONTACT LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/1990|09/11/1990|||APPR|
P890054|S001|POLYMER TECHNOLOGY CORP.|100 RESEARCH DR.||WILMINGTON|MA|01887||Accessories, soft lens products|THE BOSTON TM CLEANER II|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/1994|08/15/1994|||APPR|
P890056|S001|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/1991|02/08/1995|||APPR|
P890057|S001|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1991|06/27/1991|||APPR|
P890057|S002|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100A FREQUENCY OSCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/03/1992|06/22/1992|||APPR|
P890057|S003|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.|LSZ|AN|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/29/1992|09/15/1995|||APPR|
P890057|S004|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.|LSZ|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1993|06/12/1995|||APPR|
P890057|S005|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/15/1993|03/23/1995|||APPR|
P890058|S001|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/1990|08/15/1990|||APPR|
P890058|S002|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/1990|09/14/1990|||APPR|
P890058|S003|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1990|10/25/1990|||APPR|
P890058|S004|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1990|10/31/1990|||APPR|
P890058|S005|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1990|11/14/1990|||APPR|
P890058|S006|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS (ROSILFOCON A)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/1990|12/19/1990|||APPR|
P890058|S007|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS (ROSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/1991|07/19/1991|||APPR|
P890058|S008|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS (ROSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/1991|03/21/1991|||APPR|
P890058|S009|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS (ROSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/1991|05/28/1991|||APPR|
P890058|S010|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS (ROSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1992|09/02/1993|||APPR|
P890058|S011|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS (ROSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/1993|04/06/1993|||APPR|
P890058|S012|OCUTEC CORPORATION, INC.|2700-200 GATEWAY CENTER BLVD.||MORRISVILLE|NC|27560||Lens, contact (other material) - daily|NOVALENS (ROSILFOCON A)|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/1993|01/04/1994|||APPR|
P890059|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PD 1343 DISINFECTING TABLET|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1994|12/13/1994|||APPR|
P890061|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P MODELS 1600&1610 & SOFTWARE MODULE 2830|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/1991|02/10/1992|||APPR|
P890061|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6577 STERILIZABLE TELEMETRY WAND|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/1991|11/26/1991|||APPR|
P890061|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P MODEL 1600|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/1992|05/14/1992|||APPR|
P890061|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P MODEL 1600|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1992|09/24/1992|||APPR|
P890061|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P MODEL 6910|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/1993|12/14/1993|||APPR|
P890061|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P MODEL 1600|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/1993|08/08/1994|||APPR|
P890062|S003|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|CIBA VISION CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1990|03/21/1991|||APPR|
P890063|S002|MATRIA HEALTHCARE, INC.|1850 PARKWAY PLACE|SUITE 1200|MARIETTA|GA|30067||MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)|GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.|HFM|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/21/1990|04/10/1991|||APPR|
P890063|S003|MATRIA HEALTHCARE, INC.|1850 PARKWAY PLACE|SUITE 1200|MARIETTA|GA|30067||MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)|GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.|HFM|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/1991|01/31/1994|||APPR|
P890063|S004|MATRIA HEALTHCARE, INC.|1850 PARKWAY PLACE|SUITE 1200|MARIETTA|GA|30067||MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)|GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)|HFM|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1993|06/16/1995|||APPR|
P890064|S001|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT|MAQ|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/1991|05/17/1993|||APPR|
P890064|S002|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1992|05/19/1994|||APPR|
P890064|S003|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/27/1993|04/28/1995|||APPR|
P890065|S001|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|RADIOIMMUNOASSAY FOR CYCLOSPORINE|1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS|MGV|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/1990|01/30/1991|||APPR|
P890066|S001|FOCUS SURGERY, INC.|1565 BARBER LN.||MILPITAS|CA|95035||Lithotriptor, extracorporeal shock-wave,urological|THERASONIC LITHOTRIPSY TREATMENT SYSTEM|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/1991|03/01/1992|||APPR|
P890066|S003|FOCUS SURGERY, INC.|1565 BARBER LN.||MILPITAS|CA|95035||Lithotriptor, extracorporeal shock-wave,urological|THERASONIC LITHOTRIPSY TREATMENT SYSTEM|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1991|10/29/1992|||APPR|
P890066|S004|FOCUS SURGERY, INC.|1565 BARBER LN.||MILPITAS|CA|95035||Lithotriptor, extracorporeal shock-wave,urological|THERASONIC LITHOTRIPSY TREATMENT SYSTEM|LNS|GU|Normal 180 Day Track|Other Report|N|03/10/1992|03/26/1992|||APPR|
P890066|S005|FOCUS SURGERY, INC.|1565 BARBER LN.||MILPITAS|CA|95035||Lithotriptor, extracorporeal shock-wave,urological|THERASONIC LITHOTRIPSY TREATMENT SYSTEM|LNS|GU|Normal 180 Day Track|Other Report|N|02/15/1994|04/18/1994|||APPR|
P890067|S001|STERIDYNE LABORATORIES, INC.|3238 CANYON LAKE DR.||LOS ANGELES|CA|90068||Accessories, soft lens products|STERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/1990|01/18/1991|||APPR|
P890067|S004|STERIDYNE LABORATORIES, INC.|3238 CANYON LAKE DR.||LOS ANGELES|CA|90068||Accessories, soft lens products|STERILE PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/30/1993|12/12/1994|||APPR|
P890067|S005|STERIDYNE LABORATORIES, INC.|3238 CANYON LAKE DR.||LOS ANGELES|CA|90068||Accessories, soft lens products|STERILE PRESERVED SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/1993|04/13/1994|||APPR|
P890068|S001|CHIRON OPHTHALMICS|9342 JERONIMO RD.||IRVINE|CA|92718||intraocular lens|TIER A & B INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/1991|10/22/1993|||APPR|
P890070|S001|GRAIN PROCESSING CORP.|1600 OREGON ST.||MUSCATINE|IA|52761||POWDER, DUSTING, SURGICAL|PURE-DENT (R)|KGP|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/1991|03/20/1991|||APPR|
P890070|S002|GRAIN PROCESSING CORP.|1600 OREGON ST.||MUSCATINE|IA|52761||POWDER, DUSTING, SURGICAL|PURE-DENT (R)|KGP|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1994|11/30/1994|||APPR|
P890070|S003|GRAIN PROCESSING CORP.|1600 OREGON ST.||MUSCATINE|IA|52761||POWDER, DUSTING, SURGICAL|PURE-DENT (R)|KGP|HO|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|08/18/1994|01/27/1995|||APPR|
P890072|S002|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1990|07/02/1991|||APPR|
P890072|S003|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/1991|07/19/1991|||APPR|
P890072|S004|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/1991|01/28/1992|||APPR|
P890072|S005|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/1992|07/22/1992|||APPR|
P890072|S006|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1992|02/09/1993|||APPR|
P890072|S007|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1993|03/23/1993|||APPR|
P890072|S008|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/1993|05/27/1993|||APPR|
P890072|S009|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|08/06/1993|09/07/1993|||APPR|
P890072|S010|PROGRESSIVE CHEMICAL RESEARCH LTD.|P.O. BOX 8218, STN. "F"||CALGARY, ALBERTA||T2J 2||Lens, contact (other material) - daily|ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1993|01/07/1994|||APPR|
P900001|S001|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP II - F CONTACT LENS|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/1991|03/18/1991|||APPR|
P900001|S002|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|SGP II - F CONTACT LENS|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/1991|05/06/1991|||APPR|
P900001|S003|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/1991|08/06/1991|||APPR|
P900001|S004|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1991|01/14/1992|||APPR|
P900001|S005|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/1992|04/14/1992|||APPR|
P900001|S006|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1992|10/02/1992|||APPR|
P900001|S007|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/1992|12/04/1992|||APPR|
P900001|S008|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/1992|12/04/1992|||APPR|
P900001|S009|THE LIFESTYLE CO., INC.|712 GINESI DR.||MORGANVILLE|NJ|07751||Lens, contact (other material) - daily|RIGID GAS PERMEABLE CONTACT LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1993|05/27/1993|||APPR|
P900010|S001|OPTICAL RADIATION CORP.|1300 OPTICAL DR.||AZUSA|CA|91702||AID, SURGICAL, VISCOELASTIC|ORCOLON (R) (POLYACRYLAMIDE)|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/14/1991|07/03/1991|||APPR|
P900010|S002|OPTICAL RADIATION CORP.|1300 OPTICAL DR.||AZUSA|CA|91702||AID, SURGICAL, VISCOELASTIC|ORCOLON (R) (POLYACRYLAMIDE)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1991|07/31/1991|||APPR|
P900022|S001|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|CHORUS(R) MODEL 6004&6034 DDD MODEL CPRI MODEL P2A|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1991|03/18/1992|||APPR|
P900022|S003|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|CHORUS(R) MODEL 6001,3,33 DDD MODEL CPRI MODEL P2A|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/1991|03/13/1992|||APPR|
P900023|S001|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/06/1993|07/12/1993|||APPR|
P900023|S002|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/22/1993|04/08/1993|||APPR|
P900023|S004|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/1993|08/20/1993|||APPR|
P900023|S005|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1993|11/23/1993|||APPR|
P900023|S006|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/1993|11/23/1993|||APPR|
P900023|S007|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/1993|06/21/1994|||APPR|
P900023|S008|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1993|01/24/1994|||APPR|
P900023|S009|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/1994|11/17/1994|||APPR|
P900023|S010|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/1994|09/23/1994|||APPR|
P900023|S011|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/1994|09/30/1994|||APPR|
P900023|S012|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1994|01/24/1995|||APPR|
P900023|S013|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/31/1994|01/29/1996|||APPR|APPROVAL FOR INCREASING THE LEFT SIDE FLOW CAPACITY OF THE ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM BY APPROXIMATELY 1 LITE/MINUTE (I.E., FROM 5 LITERS/MINUTE TO APPROXIMATELY 6 LITERS/MINUTE
P900023|S014|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1994|03/23/1995|||APPR|
P900025|S001|ZEUS SCIENTIFIC, INC.|200 EVANS WAY||BRANCHBURG|NJ|08876||KIT, ASSAY, PROGESTERONE RECEPTOR|FLUORO-CEP (R) PROGESTERONE|LPI|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/1991|04/21/1992|||APPR|
P900025|S002|ZEUS SCIENTIFIC, INC.|200 EVANS WAY||BRANCHBURG|NJ|08876||KIT, ASSAY, PROGESTERONE RECEPTOR|FLUORO-CEP (R) PROGESTERONE|LPI|CH|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/1991|04/17/1992|||APPR|
P900030|S001|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1993|03/28/1994|||APPR|
P900030|S002|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT|LNM|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/1994|11/23/1994|||APPR|
P900030|S003|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1994|03/03/1995|||APPR|
P900032|S001|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER (LASER CATHETER-MODEL PC4010(1.3MM))|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1992|06/22/1993|||APPR|
P900032|S002|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER (LASER CATHETER-MODEL PC4021(1.6MM))|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1992|06/22/1993|||APPR|
P900032|S003|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER (LASER CATHETER-MODEL PC4030(2.0MM))|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1992|10/19/1993|||APPR|
P900032|S006|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER MODEL PC4016(1.3MM),4026(1.6MM)|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/1992|08/12/1993|||APPR|
P900032|S013|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER MODEL LAISER II|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/1992|01/08/1993|||APPR|
P900032|S015|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER MODEL DYMER (R) 200+|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1992|10/25/1993|||APPR|
P900032|S016|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER MODEL DYMER (R) 200+|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/17/1992|03/18/1993|||APPR|
P900032|S018|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/1993|06/14/1994|||APPR|
P900032|S019|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/1993|06/14/1994|||APPR|
P900032|S020|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1993|11/23/1993|||APPR|
P900039|S001|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE|MBS|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/03/1992|01/27/1994|||APPR|
P900039|S002|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE|MBS|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1993|08/05/1993|||APPR|
P900039|S003|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE|MBS|OR|Normal 180 Day Track|Other Report|N|10/01/1993|12/09/1993|||APPR|
P900039|S005|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT(TM) BONE GRAFT MATRIX|MBS|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/20/1994|09/30/1994|||APPR|
P900039|S006|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT(TM) BONE GRAFT MATRIX|MBS|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/1994|03/21/1995|||APPR|
P900047|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK(TM) REWETTING DROPS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1994|04/05/1994|||APPR|
P900048|S001|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/1991|03/05/1992|||APPR|
P900048|S002|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/28/1992|08/23/1993|||APPR|
P900050|S001|QUEST TECHNOLOGIES CORP.|766 PALOMAR AVE.||SUNNYVALE|CA|94086|9716|Wheelchair, stair climbing|ACCESS MOBILITY SYSTEM|IMK|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1992|06/14/1993|||APPR|
P900052|S002|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST|LNY|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/1994|10/13/1995|||APPR|APPROVAL FOR A STERILIZATION PROCESS CHAGE FROM BETA IRRADIATION TO ETHYLENE OXIDE GAS, PACKAGING CHANGES TO A INNER AND OUTER TRAY CONFIGURATION WITH A SHELF CARTON AND REMOVAL (PER OUR GUIDANCE) OF THE SHELF-LIFE STERILITY DATING FOR THE PORT-A-CATH INTRASPINAL IMPLANTABLE ACCESS SYSTEM
P900056|S001|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/1993|03/17/1994|||APPR|
P900056|S002|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1993|01/10/1994|||APPR|
P900056|S003|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1993|01/07/1994|||APPR|
P900056|S004|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1993|01/24/1995|||APPR|
P900056|S005|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/1993|12/07/1993|||APPR|
P900056|S006|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/1993|07/12/1995|||APPR|APPROVAL TO RELOCATE MANUFACTURING FACILITY TO REDMOND, WASHINGTON
P900056|S008|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1994|05/22/1995|||APPR|
P900058|S001|WESTCON CONTACT LENS CO., INC.|2775 CROSSROADS BLVD.|SUITE 110|GRAND JUNCTION|CO|81506||Lenses, soft contact, daily wear|FLEXLENS (HEFILCON A) SOFT CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/1991|08/29/1991|||APPR|
P900059|S001|MOLECULAR BIOSYSTEMS, INC.|10030 BARNES CANYON RD.||SAN DIEGO|CA|92121||Contrast media, ultrasound|ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES|MJS|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/12/1994|07/31/1995|||APPR|APPROVAL FOR 2 TRAINING VIDOES.FDA HAS RECEIVED A JOURNAL ADVERTISING INSERT, PRODUCT FOLDER, & 2 JOURNAL ARTICLES & FIND THAT THEY ARE CONSISTENT WITH APPROVED LABELING.EXPIRATION DATING 12 MONTHS REFRIGERATED AT 2 TO 8 DEGREES CELSIUS
P900059|S002|MOLECULAR BIOSYSTEMS, INC.|10030 BARNES CANYON RD.||SAN DIEGO|CA|92121||Contrast media, ultrasound|ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES|MJS|RA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/1994|03/01/1996|||APPR|APPROVAL FOR RELEASE OF THE FINAL PRODUCT BASED ON USP STERILITY TESTING PERFORMED BY MOLECULAR BIOSYSTEMS, INC. RATHER THAN NAMSA, IRVINE, CA
P900060|S001|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1993|04/13/1994|||APPR|
P900060|S002|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/1993|12/21/1993|||APPR|
P900060|S003|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1994|02/16/1995|||APPR|
P900060|S004|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/22/1994|04/13/1994|||APPR|
P900060|S005|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/23/1994|07/08/1994|||APPR|
P900060|S006|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/1994|08/14/1995|||APPR|REPLACEMENT OF THE DEPYROGENATION OVENS USED IN THE DEPYROGENATION PROCESS OF THE CPHV
P900061|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MULTIPROGRAMMABLE TACHYARRHYTHMIA CONTROL SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/1993|06/01/1994|||APPR|
P900061|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/1993|03/31/1994|||APPR|
P900061|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/1993|04/04/1994|||APPR|
P900061|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1994|05/25/1994|||APPR|
P900061|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1994|05/25/1994|||APPR|
P900061|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 7217D PCD(TM) TACHYARRHYTHMIA CONTROL SYS.|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1994|07/20/1994|||APPR|
P900061|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1994|03/17/1995|||APPR|
P900061|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/1994|08/22/1995|||APPR|APPROVAL FOR MEDTRONIC, INC., MED-REL, ROAD 909, KM. 0.4., BARRIO MARIANA, HUMACAO, PUERTO RICO, TO MANUFACTURE THE MODEL 7219D JEWEL PCD AND THE MODEL 7202D JEWEL CD
P900065|S001|WESTCON CONTACT LENS CO., INC.|2775 CROSSROADS BLVD.|SUITE 110|GRAND JUNCTION|CO|81506||Lenses, soft contact, daily wear|TECHNICON-38 (POLYMACON) HYDROPHYLIC   LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/1991|08/29/1991|||APPR|
P900065|S003|WESTCON CONTACT LENS CO., INC.|2775 CROSSROADS BLVD.|SUITE 110|GRAND JUNCTION|CO|81506||Lenses, soft contact, daily wear|TECHNICON-38 POLYMACON HYDROPHILIC LENS|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/1992|02/11/1993|||APPR|
P900070|S001|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACING SYSTEM MODEL 1254/FUNC.1250H|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1992|06/29/1993|||APPR|
P900070|S002|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|MODEL 9600 PROG.,1250H GENERATOR SOFTWARE V4.10UE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1992|01/07/1993|||APPR|
P900070|S003|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|CODEL 9600,4810,4510 5603,INTERFACE CABLE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/1992|04/19/1993|||APPR|
P900070|S004|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACING SYSTEM|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/1993|04/21/1993|||APPR|
P900070|S005|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1993|02/24/1994|||APPR|
P900070|S006|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B (FORMERLY 1256R)|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1993|12/20/1996|||APPR|APPROVAL FOR THE META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B TO BE MANUFACTURED AT THE MIAMI LAKES, FLORIDA SITE.
P900070|S007|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1993|07/12/1995|||APPR|APPROVAL FOR ADDITION OF NON-INVASIVE PROGRAMMED STIMULATION (NIPS)
P900070|S009|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/1994|07/23/1996|||APPR|APPROVAL FOR A CHANGE IN STERILIZATION CONTRACTOR. THE PROPOSED STERILIZATION CONTRACTOR IS: GRIFFITH MICRO SCIENCE, INC., 2973 OLYMPIC INDUSTRIAL DRIVE, SMYRNA, GEORGIA 30080-7322
P910001|S001|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1992|10/18/1993|||APPR|
P910001|S002|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/1992|09/23/1993|||APPR|
P910001|S005|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1993|07/31/1995|||APPR|APPROVAL FOR VITESSE-E (MODEL 117-005) & VITESSE-E II (MODEL 117-205) CATHETERS TO BE USED WITH THE CVX-300 EXCIMER LASER SYSTEM ON ECCENTRIC LESIONS MEETING ONE OR MORE OF YOUR APPROVED INDICATIONS FOR USE
P910001|S006|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/07/1993|10/31/1994|||APPR|
P910001|S007|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/16/1994|11/15/1994|||APPR|
P910001|S008|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1994|07/12/1995|||APPR|APPROVAL FOR UPGRADED SOFTWARE (VERSION 3.4) FOR THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
P910001|S009|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Other Report|N|09/12/1994|03/24/1995|||APPR|
P910001|S010|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/1994|05/16/1995|||APPR|
P910007|S001|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ABBOTT IMX(R) PSA*|LTJ|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/1992|09/13/1994|||APPR|
P910007|S002|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ABBOTT AXSYM PSA (LIST 7A49)|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1994|03/29/1995|||APPR|
P910007|S003|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ABBOTT IMX PSA|LTJ|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/1994|10/17/1994|||APPR|
P910007|S004|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ABBOTT IMX PSA|LTJ|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/02/1994|08/07/1997|97M-0501||APPR|Approval for the addition of a new intended use and is indicated for the quantitative measurement of Prostate Specific Antigen (PSA) in: 1) Human serum as an adjunctive test used as an aid in the management of prostate cancer patients; 2) Human serum as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men aged 50 years or older.  Prostatic biopsy is required for diagnosis of cancer.
P910016|S002|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE|MBD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/1993|06/08/1993|||APPR|
P910016|S004|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE|MBD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1994|08/23/1994|||APPR|
P910019|S001|INTENSIVE TECHNOLOGY, INC.|3574 RUFFIN RD.||SAN DIEGO|CA|92123||CATHETER, CORONARY, ATHERECTOMY|IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/13/1994|01/05/1995|||APPR|
P910020|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/1992|12/29/1992|||APPR|
P910020|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1992|01/11/1993|||APPR|
P910020|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY/DASH/STRIDE & DART PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1992|05/06/1994|||APPR|
P910020|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|UNITY - C MODEL 292-06 PULSE GENERATOR & ACCS.|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/1992|01/23/1995|||APPR|
P910020|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY-DASH PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/1993|06/09/1994|||APPR|
P910020|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY-DASH PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/1993|01/18/1995|||APPR|
P910020|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY-DASH PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1993|01/17/1995|||APPR|
P910020|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY/DASH/STRIDE/DART PACING SYSTEMS|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/1994|04/27/1995|||APPR|
P910023|S001|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1993|07/29/1994|||APPR|
P910023|S002|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/1993|05/09/1994|||APPR|
P910023|S003|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/1993|10/28/1994|||APPR|
P910023|S004|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1993|06/16/1994|||APPR|
P910023|S005|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/1994|03/28/1994|||APPR|
P910023|S006|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/1994|10/28/1994|||APPR|
P910023|S007|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/1994|01/17/1995|||APPR|
P910023|S008|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/26/1994|10/31/1995|||APPR|APPROVAL FOR THE CADENCE V-112 PULSE GENERATOR SERIES (B,C,D,E) WITH PROGRAMMER SOFTWARE VERSION 3.3
P910023|S009|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/1994|01/23/1995|||APPR|
P910029|S001|LES LABORATORIES BLONCHARD|1552, RUE KING OUEST|SUITE 200|SHERBROOKE|IL|00000|0000|Lenses, soft contact, daily wear|HYDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1992|06/29/1993|||APPR|
P910029|S002|LES LABORATORIES BLONCHARD|1552, RUE KING OUEST|SUITE 200|SHERBROOKE|IL|00000|0000|Lenses, soft contact, daily wear|\YDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1993|11/23/1993|||APPR|
P910030|S001|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||STENT, CORONARY|GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1992|08/30/1993|||APPR|
P910030|S002|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||STENT, CORONARY|GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/14/1993|01/27/1994|||APPR|
P910030|S003|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||STENT, CORONARY|GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/1994|05/17/1995|||APPR|
P910031|S001|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|ORACLE(TM) CORONARY BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1994|06/05/1995|||APPR|
P910056|S001|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|CHIROFLEX II MODIFIED J LOOP SILICONE INTRA. LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/06/1991|03/31/1995|||APPR|
P910056|S002|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|CHIROFLEX II MODIFIED J LOOP SILICONE INTRA. LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/1992|03/28/1994|||APPR|
P910056|S003|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|CHIROFLEX II MULTI PIECE SILICON IOL CHANGE TEST|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/1992|02/17/1995|||APPR|
P910058|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHIROFLEX(TM) MODEL C10UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1991|03/29/1995|||APPR|
P910058|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHIROFLEX(TM) SINGLE PIECE SILICONE POST. CHAM.IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/1991|07/29/1994|||APPR|
P910058|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHIROFLEX(TM) ADD MODEL 32-C11XX SINGLE PIECE  IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/1992|07/29/1994|||APPR|
P910058|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHIROFLEX(TM) MODEL 32-C10XX SILICONE POS.CHA.IOL|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/1993|08/11/1994|||APPR|
P910060|S001|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIMIDE(TM) IOL MODEL AQ-2010|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/1992|04/20/1994|||APPR|
P910064|S001|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Other Report|N|05/26/1993|07/24/1995|||APPR|APPROVAL FOR THE ACCELERATED & REAL-TIME AGING STUDIES TO ESTABLISH A NEW SHELF LIFE FOR THE REALITY FEMALE CONDOM
P910064|S002|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY(TM) VAGINAL POUCH|MBU|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/1993|07/09/1993|||APPR|
P910064|S003|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Other Report|N|07/06/1993|10/18/1994|||APPR|
P910064|S004|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Other Report|N|07/12/1993|07/24/1995|||APPR|PROVIDED ADD'L DATA ON THE IN VITRO BARRIER PROPERTIES OF THE DEVICE WITH RESPECT TO SEXUALLY TRANSMITTED DISEASES.  THESE DATA WERE PROVIDED IN SATISFACTION OF THE CONDITIONS OF APPROVAL CONTAINED IN FDA'S MAY 7, 1993 LETTER
P910064|S005|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/1993|04/13/1994|||APPR|
P910064|S006|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/30/1993|07/24/1995|||APPR|APPROVAL OF THE FOCUS GROUP STUDY PROTOCOL TO ASSESS PATIENT COMPREHENSION OF PRODUCT LABELING
P910064|S007|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1993|07/31/1995|||APPR|APPROVAL FOR CHANGE TO THE PROFESSIONAL MONOGRAPH & PATIENT DEVICE LABELING TO INCLUDE INFORMATION ON, OR INSTRUCTIONS FOR, THE CONCOMITANT USE OF A SPERMICIDE CONTAINING NONOXYNOL-9 W/REALITY FEMALE CONDOM
P910064|S008|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/1993|07/31/1995|||APPR|APPROVAL FOR AN EXTENSION OF PRODUCT SHELF LIFE:EXPIRATION DATING 36 MONTHS
P910064|S009|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Other Report|N|01/18/1994|07/24/1995|||APPR|ADDITIONAL DATA PROVIDED ON THE IN VITRO BARRIER PROPERTIES OF THE DEVICE WITH RESPECT TO SEXUALLY TRANSMITTED DISEASES.THESE DATA WERE PROVIDED IN SATISFACTION OF THE CONDITIONS OF APPROVAL CONTAINED IN FDA'S MAY 7, 1993 LETTER
P910071|S001|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL 5000|LWL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1994|11/30/1994|||APPR|
P910073|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) C LEAD, MODELS 0070, 0072,0074|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/1993|08/05/1994|||APPR|
P910073|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) CLEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1993|09/13/1994|||APPR|
P910073|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) SQ LEAD ARRAY MODEL 0048|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1994|04/17/1995|||APPR|
P910073|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/1994|11/23/1994|||APPR|
P910073|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/1994|01/25/1995|||APPR|
P910073|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1994|08/01/1995|||APPR|
P910075|S001|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WESLEY-JESSEN (R) WJD-1 MULTI-PURPOSE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/1994|04/28/1995|||APPR|
P910075|S002|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) REWETTING DROPS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/1993|03/23/1995|||APPR|
P910077|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/1994|11/23/1994|||APPR|
P910077|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX II/III AICD SYSTEM AND IS-1/DF-1 LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/1994|05/02/1995|||APPR|
P910077|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX(R) AICD(TM) SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/1994|08/03/1995|||APPR|APPROVAL FOR PROGRAM DISK MODEL 2860 REVISION 11.2 SOFTWARE OF VENTAK PRX AICD SYSTEM
P920015|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) TRANSVENE LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1994|06/24/1994|||APPR|
P920015|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) TRANSVENE LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1994|05/25/1994|||APPR|
P920015|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) TRANSVENE LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1994|07/20/1994|||APPR|
P920045|S001|STELLAR CONTACT LENS, INC.|8131 TRIPP AVENUE||SKOKIE|IL|60076||Lens, contact (other material) - daily|OP-3 (TM) RGP CONTACT LENS|HQD|OP|Normal 180 Day Track|Other Report|N|01/27/1994|02/24/1994|||APPR|
P920047|S001|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 TC CARDIAC ABLATION SYSTEM WITH TEMPERATURE CONTROL|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1994|11/08/1995|||APPR|APPROVAL FOR AN ALTERNATE CONFIGURATION OF THE EPT-1000 CARDIAC ABLATION CONTROLLER WHICH INCORPORATES A TEMPERATURE CONTROL FEATURE
P920047|S002|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|E P TECH CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1994|08/14/1995|||APPR|APPROVAL FOR EPT-1000 GRAPHICS SOFTWARE
P940013|S001|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, daily wear|PRECISION(TM) UV (VASURFILCON)|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/1994|02/09/1995|||APPR|
P940013|S002|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, daily wear|PRECISION(TM) UV (VASURFILCON)|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/1994|11/09/1994|||APPR|
N17600|S013|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/1995|12/27/1995|||APPR|APPROVAL FOR AN ALTERNATIVE FINISHED DEVICE FACILITY AT 160 NEW BOSTON STREET, WOBURN, MA 01801
N17600|S014|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/1995|09/14/1995|||APPR|APPROVAL FOR THE ADDITION OF SPRAY DELIVERY DEVICES FOR AVITENE MICROFIBRILLAR COLLAGTEN HEMOSTAT
N17679|S029|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|VANTAGE (TETRAFILCON A ) CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1995|07/28/1995|||APPR|APPROVAL FOR REDUCTION OF THE INCUBATION TIEM OF THE BIOLOGICAL INDICATOR USED IN THE LENS STERILIZATION PROCESS TO FORTY-EIGHT HOURS.
N18073|S024|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1995|10/31/1995|||APPR|APPROVAL FOR ALTERNATE STERILIZATION FACILITY LOCATED AT STERIGENICS (FORMERLY RADIATION STERILIZATION, INC.) 344 BONNIE CIRCLE, CORONA, CA FOR THE GAMMA IRRADIATION OF THE CONTAINER/CLOSURE COMPONENTS FOR THE ABOVE REFERENCED DEVICES
N18078|S049|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFTMATE SALINE SOLUTION FOR SENSITIVE EYES|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1995|10/31/1995|||APPR|APPROVAL FOR ALTERNATE STERILIZATION FACILITY LOCATED AT STERIGENICS (FORMERLY RADIATION STERILIZATION, INC.), 344 BONNIE CIRCLE, CORONA, CA FOR THE GAMMA IRRADIATION OF THE CONTAINER/CLOSURE COMPONENTS FOR THE ABOVE REFERENCED DEVICES.
N50510|S067|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/22/1995|04/19/1995|||APPR|
N5798|S007|BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC|ONE BECTON DR.||FRANKLIN LAKES|NJ|07417|1880|Agent, absorbable hemostatic, non-collagen based|OXYCELL|LMG|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/1995|07/24/1995|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR POST-STERILIZATION LOTS OF OXYCEL
N80023|S001|KELLER AND HECKMAN|1001 G STREET, N.W.|SUITE 500 WEST|WASHINGTON|DC|20001|||ABSORBABLE DUSTING POWDER||HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/1995|02/20/1998|||APPR|Approval for a change to the manufacturing process.
P790018|S024|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE AND VALVED CONDUITS|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/1995|05/13/1996|||APPR|APPROVAL FOR THE USE OF OCCLUDERS MADE BY MEDTRONIC CARBON IMPLANTS (MCI) OF AUSTIN, TEXAS, AS A COMPONENT OF THE MEDTRONIC HALL PROSTHETIC HEART VALVE AND VALVED CONUITS, MODELS A7700, M7700, C7700, AND Z7700
P790018|S025|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/1995|01/02/1996|||APPR|APPROVAL FOR THE 24MM MEDTRONIC-HALL PROSTHETIC HEART VALVE, MODEL A7700 AHK
P790019|S006|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M DIAGNOSTIC KIT|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1994|05/29/1996|||APPR|APPROVAL TO EXTEND EXPIRATION DATING TO 70DAYS FROM THE DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUS
P790019|S007|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M EIA DIAGNOSTIC KIT|LOL|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1994|05/29/1996|||APPR|APPROVAL TO EXTEND EXPIRATION DATING TO 8 MONTHS FROM THE DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUS
P790025|S006|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT: 09VA BLDG: AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT HBE (RDNA) EIA|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/02/1994|05/17/1996|||APPR|APPROVAL TO MODIFY THE PRODUCT LABELING TO ENHANCE THE SAFETY IN THE USE OF THE ABBOTT HBE (RDNA) EIA. THE LIMITATIONS SECTION WILL BE MODIFIED TOSTATE THAT "SAMPLES CONTAINING RHEUMATOID FACTOR AMY DEMONSTRATE FALSELY ELEVATED VALUES IN THE HBEAG ASSAY," AND THE INTERPRETATION OF RESULTS SECTION WILL BE MODIFIED TOSTATE THAT "IT IS RECOMMENDED THAT PATIENTS BE SCREENED FOR THE PRESENCE OF HBSAG PRIOR TO BEING EVALUATED FOR THE PRESENCE OF HBEAG."
P790025|S007|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT: 09VA BLDG: AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT HBE (RDNA) EIA TEST KIT|LOM|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/1995|02/16/1996|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS FROM THE USE OF RECALCIFIED ANTI-HBE POSITIVE HUMAN PLASMA FROM ONE DONOR TO THE USE OF AN ALTERNATE SOURCE OF ANTI-HBE POSITIVE PLASMA FOR BEAD COATING
P800018|S020|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|SOFT MATE COMFORT DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1995|10/31/1995|||APPR|APPROVAL FOR ALTERNATE STERILIZATION FACILITY LOCATED AT STERIGENICS (FORMERLY RADIATION STERILIZATION, INC.), 344 BONNIE CIRCLE, CORONA, CA, FOR THE GAMMA IRRADIATION OF THE CONTAINER/CLOSURE COMPONENTS FOR THE ABOVE-REFERENCED DEVICES
P800024|S017|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB RENEW (R) SALINE SOLN. (BL-101-BEU13|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/1995|05/05/1995|||APPR|
P800049|S006|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P810001|S011|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P810002|S033|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R)|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/09/1994|03/14/1995|||APPR|
P810002|S034|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R)|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/1994|02/16/1995|||APPR|
P810002|S035|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/1995|07/31/1995|||APPR|APPROVAL FOR USE OF THE WOODRIDGE CARBON TECHNOLOGY CENTER, LITTLE CANADA, MINNESOTA, AS AN ALTERNATE SUPPLIER OF THE PYROLITIC CARBON LEAFLET & ORIFICE COMPONENTS USED IN THE ST.JUDE MEDICAL MECHANICAL HEART VALVE
P810018|S034|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|UV ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P810032|S047|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|UV ABSORBING POST.CHAM.IOL|HQL|OP|||N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P810046|S154|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX LIFESTREAM(TM) CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1995|06/14/1995|||APPR|
P820003|S070|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 5348 TEMPORARY PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/1995|10/31/1995|||APPR|
P820018|S066|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|REFLEX MODEL 8223E|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/1995|07/11/1996|||APPR|APPROVAL FOR THE USE OF WILSON GREATBATCH BATTERIES WHICH HAVE UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING
P820021|S025|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/1995|12/13/1995|||APPR|APPROVAL FOR THE LENS BLANKS FOR NEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES MANUFACTURED AT CIBA VISION CORORATION, 2910 AMWILER COURT, ATLANTA, BA TO BE FINAL CURED, WET PROCESSED, TINTED, PACKGED, AND STERILIZAED AT THE ALTERNATE MANUFACTURING SITE, CIBA VISION BATAM, BATAM INDUSTRIAL PARK, LOT #204, MUKA KUNING 29433, BATAM ISLAND, INDONESIA
P820021|S026|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/17/1995|03/31/1995|||APPR|
P820035|S013|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P820049|S060|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC-58NBM & PC-58NBZ IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/30/1994|10/18/1995|||APPR|APPROVAL FOR MODELS PC-58NBM AND PC-58NBZ AS LOW-DIOPTER, TIER A MODIFICATIONS OF A PREVIOUSLY APPROVAL ALLERGAN MEDICAL OPTICS LENS.  THESE LENSES WILL BE OFFERED IN POWERS FROM -10.0 TO +5.5 DIOPTERS
P820053|S023|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1995|10/31/1995|||APPR|APPROVAL FOR ALTERNATE STERILIZATION FACILITY LOCATED AT STERIGENICS (FORMERLY RADIATION STERILIZATION, INC.) 344 BONNIE CIRCLE, CORONA, CA FOR THE GAMMA IRRADIATION OF THE CONTAINER/CLOSURE COMPONENTS FOR THE ABOVE-REFERENCED DEVICES
P820076|S018|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|BIOTRONIK GEMNOS 04 AND GEMNOS TC O4|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/1995|11/21/1996|||APPR|USE OF SELF-SEALING HEADER AND SPRING CONTACTOR, WHICH REPLACES THE CURRENT HEADER DESIGN UTILIZING SEPARABLE SETSCREWS AND SEALING CAPS
P820083|S020|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) SUTURE|GAW|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1995|06/05/1995|||APPR|
P830026|S062|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 531-45 GRAPHICS PROGRAM MODULE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1994|01/23/1995|||APPR|
P830026|S063|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 531-45 GRAPHICS PROGRAM MODULE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1994|01/23/1995|||APPR|
P830034|S026|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1995|10/31/1995|||APPR|APPROVAL OF A MULTI-PURPOSE SOLUTION FOR CLEANING, RINSING, DISINFECTING, AND STORING SOFT (HYDROPHILIC) CONTACT LENSES. THIS DEVICE IS A MODIFICATION OF THE APPROVED OPTI-FREE RINSING, DISINFECTING, AND STORAGE SOLUTION DUE TO THE ADDITION OF LOW CONCENTRATIONS OF SURFACTANTS. THE SOLUTION WILL BE MARKETED IN 1.5FL.OZ, 4FL.OZ., 8FL.OZ., 12FL.OZ., & 16FL.OZ. SIZE BOTTLES
P830040|S024|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P830055|S040|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/1995|11/01/1995|||APPR|APPROVAL FOR ADDTION OF A CONTRACT STERILIZATION VENDOR, SWANN-MORTON LIMITED, OWLERTON GREEN, SHEFFIELD, ENGLAND
P830055|S041|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/1995|11/06/1995|||APPR|APPROVAL OF ETHYLENE OXIDE STERILIZATION OFR POLYETHYLENE COMPONENTS AS AN ALTERNATIVE TO GAMMA RADIATION STERILIZATION
P830060|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1994|04/13/1995|||APPR|
P830060|S037|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1994|04/13/1995|||APPR|
P830061|S025|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1995|10/31/1995|||APPR|APPROVAL FOR A CHANGE IN THE STERILIZATION PROCESS FROM THE USE OF 12 PERCENT ETHYLENE OXIDE (ET0), 88 PERCENT CFC, TO 100 PERCENT ETO
P840001|S036|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/1994|07/13/1995|||APPR|APPROVAL FOR RELOCATION OF THE STERILIZATION/PACKAGING FACILITY & A MODIFICATION IN THE STERILIZATION PROCESS FOR MODELS:7491,7492,7493,7494,7495,7496 & ASSOCIATED LEADS,RECEIVERS, & ACCESSORIES NEW FACILITY:COLUMBIA HEIGHTS,MINNESOTA 55421
P840001|S037|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/17/1995|08/29/1995|||APPR|APPROVAL FOR MEDTRONIC ITREL 3 SPINAL CORD STIMULATION (SCS) SYSTEM FOR THE TREATMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND OR LIMBS
P840008|S050|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1995|08/21/1995|||APRL|APPROVAL FOR A NEW MODEL LITHOTRIPTER TRADE NAME:DORNIER LITHOTRIPTER
P840024|S056|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1995|08/31/1995|||APPR|APPROVAL FOR THE INTRODUCTION OF A DPI TRIGGER OUT CABLE
P840024|S057|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1995|08/24/1995|||APPR|APPROVAL FOR MODIFICATION TO THE NEGATIVE BATTERY TERMINAL ON THE SPECTRA-22 AND MINI SPEECH PROCESSORS
P840039|S047|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|ONE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1994|02/08/1995|||APPR|
P840040|S047|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SYNERGY II CONVERTIBLE RAPID EXCHANGE CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/1995|02/23/1995|||APPR|
P840060|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P840064|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(TM)|LZP|OP|Normal 180 Day Track|Other Report|N|01/10/1995|04/18/1995|||APPR|
P840066|S033|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/1995|10/31/1995|||APPR|APPROVAL FOR ALTERNATE STERILIZATION FACILITY LOCATED AT STERIGENICS (FORMERLY RADIATION STERILIZATION, INC.) 344 BONNIE CIRCLE, CORONA, CA FOR THE GAMMA IRRADIATION OF THE CONTAINER/CLOSURE COMPONENTS FOR THE ABOVE REFERENCED DEVICES
P840068|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR SSI PACEMAKER SYSTEM|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1994|04/13/1995|||APPR|
P840068|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR SSI PACEMAKER SYSTEM|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/1995|06/05/1995|||APPR|
P850021|S029|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|AMERICAN EDWARDS LABORATORIES HYBRID PTCA CATHETER, PURSUIT 14 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1994|11/27/1995|||APPR|APPROVAL FOR THE PURSUITE 14 PTCA CATHETER
P850021|S030|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/1995|07/12/1995|||APPR|APPROVAL FOR A MANUFACTURING MODIFICATION TO THE INNER BODY OF THE ABOVE CATHETERS
P850049|S005|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|COOK BIRD'S NEST VENA CAVA FILTER|DTK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/06/1995|09/17/1996|||APPR|APPROVAL FOR REVISED LABELING
P850077|S021|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/1994|05/25/1995|||APPR|
P850088|S032|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1995|05/15/1995|||APPR|
P850089|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R)SP LEADS|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1995|10/31/1995|||APPR|APPROVAL FOR A CHANGE IN THE STERILIZATION PROCESS FROM HTE USE OF 12 PERCENT ETHYLENE OXIDE (ET0), 88 PERCENT CFC, TO 100 PERCENT ET0
P860002|S016|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1994|02/08/1995|||APPR|
P860003|S025|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM|LNR|GU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1995|10/03/1996|||APPR|APPROVAL FOR PACKAGING THE THREE DISPOSABLE TREATMENT COMPONENTS (TPS101 BLOOD TUBINT SET, TPS102 PHOTOCEPTOR, AND A COMMERCIALLY AVAILABLE BLOOD CENTRIFUGE BOWL) INTO A SINGEL PROCEDURAL KIT PRIOR TO STERILIZATION; 2) PACKAGING THREE PROCEDURAL KITS TOGETHER IN A SINGLE OVERSHIPPER CARTON; 3) CHANGING THE STERILIZATION CYCLE TO OE WHICH PROVIDES FOR ALONGER EXPOSURE TIME, HIGHER CONCENTRATIONS OF ETHYLENE OXIDE, AND ALLOWS FOR A COOLER PRODUCT TEMPERATURE AT THE BEGINNING OF THE EXPOSURE PHASE OF THE CYCLE; AND 4) THE USE OF ONE THERMOCOUPLE IN EACH PALLET TO MONITOR PRODUCT TEMPERATURE DURING ROUTINE STERILIZATION
P860007|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R)II MODELS 262-16|LWW|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1994|03/01/1995|||APPR|
P860019|S097|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) LEAP TRIO(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/1994|05/16/1995|||APPR|
P860019|S098|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED POC BANDIT PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/1995|05/16/1995|||APPR|
P860027|S010|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/1995|09/26/1995|||APPR|APPROVAL FOR THE MAWSTRO II MODEL 533 PACEMAKER SYSTEM
P860040|S013|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, daily wear|BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES|LPL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/1995|11/27/1995|||APPR|APPROVAL FOR RELOCATION OF THE ALTERNATE MANUFACTURER, WESTCON CONTACT LENS CO., FROM 2775 CROSSROADS BOULEVARD, #110, GRAND JUNCTION, CO 81506 TO 611 EISENHAUER STREET, GRAND JUNCTION, CO 81505 AND FOR A CHANGE IN THE STERILIZATION PROCESS TO INCLUDE PARAMETRIC RELEASE AT WESTCON CONTACT LENS CO., 611 EISENHAUER STREET, GRAND JUNCTION, CO 81505 FOR HORIZON 55 SPHERICAL AND HORIZON 55 TORIC (METHAFILCON A) HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR
P870025|S003|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR|MCP|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/1995|04/13/1995|||APPR|
P870036|S034|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) FALCON(TM) COR. BALL. DIL. CATH.|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/1995|05/16/1995|||APPR|
P870049|S023|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/1995|05/05/1995|||APPR|
P870073|S016|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL KR10UV,THREE PIECE IOL/W PMMA HAPTICS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/1994|02/08/1995|||APPR|
P880003|S034|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1994|01/05/1995|||APPR|
P880003|S036|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/1995|04/27/1995|||APPR|
P880003|S037|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/20/1995|04/27/1995|||APPR|
P880006|S022|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SENSOLOG(R) CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1995|12/06/1996|||APPR|APPROVAL FOR AN ALTERNATIVE STERILIZATION CYCLE AND A NEW STERILIZATION SITE AT THE SOLNA, SWEDEN, MANUFACTURING SITE
P880010|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|LASER WELDING REVERSE HAPTIC ASPECT RATIO|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P880027|S034|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER SHORTGOOSE NONCOMPLIANT CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/13/1995|06/05/1995|||APPR|
P880038|S029|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MEDA-MV PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/1995|07/11/1996|||APPR|APPROVAL FOR USE OF WILSON GREATBATCH BATTERIES WHICH HAVE UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING
P880038|S030|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MEDA-MV PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1995|08/14/1995|||APPR|APPROVAL FOR TELEMETRY COIL IMPROVEMENT, SCAMP PROCESSOR MICROCODE MODIFICATION, & SUBSTITUTION OF DOW SILASTIC MEDICAL ADHESIVE TYPE A FOR THE LOCTITE USED IN THE ATTACHMENT OF OSCILLATOR CRYSTALS TO CERAMICS SUBSTRATES
P880079|S013|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, soft lens products|SOFTWARE(R) PLUS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/06/1995|02/09/1995|||APPR|
P880087|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P890001|S012|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/1995|04/27/1995|||APPR|
P890003|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(TM) PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/1994|02/15/1995|||APPR|
P890003|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(TM) PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/16/1995|07/31/1995|||APPR|APPROVAL FOR UPDATED CONFIGURATION OF MODEL 979OC PROGRAMMER, & UPDATED BASELINE OPERATING SOFTWARE MODEL 9877E
P890027|S026|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1995|08/31/1995|||APPR|APPROVAL FOR THE INTRODUCTION OF A DPI TRIGGER OUT CABLE
P890027|S027|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1995|08/24/1995|||APPR|APPROVAL FOR MODIFICATION TO THE NEGATIVE BATTERY TERMINAL ON THE SPECTRA-22 AND MINI SPEECH PROCESSORS
P890032|S019|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/1994|12/13/1994|||APPR|
P890032|S020|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1995|04/27/1995|||APPR|
P890039|S014|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/1995|05/16/1995|||APPR|
P890043|S028|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM),SCA-EX(TM), SCA-EX 7 FRENCH GRAFT AND ATHEROCATH-GTO(R)|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/1994|07/12/1995|||APPR|APPROVAL FOR ADDITION OF MANUFACTURING SITE:TEMECULA, CA
P890047|S005|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC TM VISCOELASTIC PREPARATION|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/1995|04/18/1995|||APPR|
P890061|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P MODEL 1600|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1994|04/11/1995|||APPR|
P900009|S001|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A|LPQ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/1995|07/07/1995|||APPR|APPROVAL FOR SUPPLEMENTARY REFERENCES FOR PHYSICIAN INSTALLATION AND PATIENT USE OF THE SAFHS MODEL 2A DEVICE
P900039|S007|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT(TM) BONE GRAFT MATRIX|MBS|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/24/1995|02/14/1995|||APPR|
P900056|S009|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/1994|08/14/1995|||APPR|CHANGE IN LOCATION FOR SEAMED CORPORATION, THE MANUFACTURER OF THE CONSOLE USED WITH THE ROTABLATOR SYSTE, FROM 11810 NORTH CREEK PARKWAY NORTH, BOTHELL, WASHINGTON, TO WEST WILLOWS TECHNOLOGY CENTER, N.E. 87TH STREET, REDMOND, WASHINGTON
P900056|S010|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/07/1995|04/27/1995|||APPR|
P900060|S007|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1994|10/26/1995|||APPR|APPROVAL TO ADD AN ADDITIONAL STERILIZATION PROTOCOL TO THE CPHV INSTRUMENTATION INSTRUCTIONS FOR USE
P900060|S009|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/1995|08/14/1995|||APPR|USE OF A MODIFIED VALVE HOLDER USED AS AN ACCESSORY WITH THE CARBOMEDICS PROSTHETIC HEART VALVE, MODELS A500, R500, M700, & S500
P900060|S010|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/1995|07/02/1996|||APPR|
P900061|S009|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/1994|06/23/1995|||APPR|
P900070|S010|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACING SYSTEM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/1995|07/11/1996|||APPR|APPROVAL FOR THE USE OF WILSON GREATBATCH BATTERIES WHICH HAVE UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING
P900070|S011|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/1995|06/21/1996|||APPR|APPROVAL FOR A MINOR MODIFICATION IN THE PULSE GENERATOR DESIGN IN THE TELEMETRY COIL CONNECTION
P910020|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY/DASH/STRIDE/DART PACING SYSTEMS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1994|03/01/1995|||APPR|
P910064|S010|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1994|07/31/1995|||APPR|
P910071|S002|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL 5000|LWL|OP|Normal 180 Day Track|Other Report|N|12/28/1994|07/14/1995|||APPR|APPROVAL FOR A PROTOCOL FOR A POSTAPPROVAL PROSPECTIVE STUDY
P910073|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1994|04/13/1995|||APPR|
P910073|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1994|04/13/1995|||APPR|
P910073|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/1995|04/27/1995|||APPR|
P910075|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) REWETTING DROPS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/1995|05/15/1995|||APPR|
P910077|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX (TM) II AICD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/1994|04/13/1995|||APPR|
P920014|S001|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE(R) 1000A IP LVAD|DSQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/1994|12/16/1999|||APPR|Approval to use Cardioflex(R) instead of Biomer for manufacturing the diaphragms for the device.  The device is indicated for use as a bridge to transplantation in cardiac trnasplant candidates at risk of imminent death from nonreversible left ventricular failure.
P920015|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) TRANSVENE LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/1995|08/14/1995|||APPR|APPROVAL FOR MODIFICATIONS TO THE TRANSVENE LEAD TECHNICAL MANUALS
P920032|S001|PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE|MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER|JOQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/1994|08/28/1995|||APPR|APPROVAL FOR THE MICRO-PACE MODELS 4570, 4573, & 4575 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKERS
P920047|S003|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|E P TECH EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1994|02/05/1996|||APPR|
P920047|S004|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|E P TECH EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/1995|08/14/1995|||APPR|RELOCATION OF ONE OF THE CONTRACT MANUFACTURERS (SEAMED CORPORATION) WHO MANUFACTURERS THE EPT-1000 RF GENERATOR
P930014|S001|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/1995|07/24/1995|||APPR|APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
P930029|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR(TM) RFCA SYSTEM|LPB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/15/1995|05/17/1995|||APPR|
P930029|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR(TM) RFCA SYSTEM AND THR RF MARINR NTC|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/20/1995|06/23/1995|||APPR|
P930035|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P3 AICD(TM) SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/10/1994|09/08/1995|||APPR|APPROVAL FOR VENTAK P3 W/VENTAK SOFTWARE MODULE, ENDOTAK C LEAD, ENDOTAK SQ PATCH LEAD, ENDOTAK SQ LEAD ARRAY, AICD Y CONNECTOR, EPICARDIAL PATCH LEAD; SOFTWARE MODULE MODEL 2836 REVISION 2.1 SOFTWARE; AND ALTERNATE STERILIZATION PROCESS
P940013|S004|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, daily wear|PRECISION(TM) UV (VASURFILCON)|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/1994|04/19/1995|||APPR|
N17679|S030|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|VANTAGE (TETRAFILCON A ) CONTACT LENS|LPM|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/1995|04/17/1995|||APPR|
P790020|S056|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/1995|04/17/1995|||APPR|
P800022|S047|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/1995|04/26/1995|||APPR|
P820018|S067|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AUTIMA AURORA CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/29/1995|04/23/1996|||APPR|APPROVAL FOR SUBSTRATE DESIGN CHANGES ALREADY IMPLEMENTED
P880040|S003|PIERCE BIOTECHNOLOGY, INC.|3747 NORTH MERIDIAN RD.|P.O. BOX 117|ROCKFORD|IL|60115||ASSAY, INTERLEUKIN|CELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT|MAN|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/1995|08/07/1996|||APPR|APPROVAL FOR A CHANGE IN ADDRESS OF THE MANUFACTURING SITE AND UPDATES AND REVISIONS IN STANDARD OPERATING PROCEDURES AND MANUFACTURING INFORMATION
P910031|S002|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|ORACLE(TM) CORONARY BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/1995|10/03/1995|||APPR|APPROVAL FOR THE FACT BALLOON CORONARY DILATATION CATHETER MARKETED UNDER TRADE NAME FACT BALLOON CORONARY DILATATION CATHETER
P920047|S005|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|E P TECH EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/1995|05/16/1995|||APPR|
P930035|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P3 AICD(TM) SYSTEM|LWS|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/1995|05/25/1995|||APPR|
N12159|S014|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/1995|05/12/1995|||APPR|
N17786|S024|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
N18020|S039|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN HYDROCARE PRESERVED SALINE SOLUTION, SORBICARE SALINE, AND PRESERVED SALINE|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE,AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
N18286|S008|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/1995|05/16/1995|||APPR|
N50510|S068|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1995|01/17/1996|||APPR|APPROVAL FOR OFLOXACIN TO BE INCLUDED ON THE GRAM NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 1, 4, AND 10 MCG/ML)
P790017|S056|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) GRUNTZIG DILACA CATHETER|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/1995|06/12/1995|||APPR|
P790024|S024|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|EASYCLEAN/GP, LC-65, LENS CLEAR, AND LENS PLUS, DAILY CLEANERS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
P800065|S014|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
P810046|S155|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILITATION CATHETER|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/1995|06/07/1995|||APPR|
P820049|S061|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC-58NBM & PC-58NBZ IOLS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/04/1995|07/28/1995|||APPR|APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR STERILIZATION OF LENSES USING PREVIOUSLY APPROVED 100% (ETO) STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE-POUCH/100% ETO STERILIZED LENSES
P820076|S019|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1995|01/24/1996|||APPR|APPROVAL FOR THE MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
P830055|S042|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1995|12/13/1995|||APPR|APPROVAL OF MINIMUM DOSE GAMMA IRRADIATION VALIDATION FOR POLYETHYLENE COMPONENTS
P830060|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1995|11/20/1995|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR ASSEMBLY OF THE EXTERNAL PRODUCTS (PROGRAMMERS, SOFTWARE MODULES/DISKS, EXTERNAL CARDIOVERTER DEFIBRILLATORS, AND RELATED ACCESSORIES) WHICH ARE USED WITH CPI PACEMAKER AND AICD SYSTEMS. THE PROPOSED ALTERNATE MANUFACTURING SITE (CARDIGAN FACILITY) IS LOCATED AT THE FOLLOWING ADDRESS:CPI CARDIGAN FACILITY, 599 CARDIGAN ROAD, SHOREVIEW, MINNESOTA 55126
P830060|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 0010 BIPOLAR ENDOCARDIAL LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/1995|08/28/1995|||APPR|APPROVAL FOR DESIGN CHANGES TO THE MODEL 0010 LEAD AND TO USE A "TRAY-IN-TRAY" PACKAGING SYSTEM FRO THE LEAD
P840008|S051|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/1995|10/05/1995|||APRL|APPROVAL FOR A TRANSPORTABLE VERSION OF THE DORNIER LITHOTRIPTER COMPACT.  THE DEVICE, AS MODIFED, WILL BE MARKETED UNDER TRADE NAME:DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)
P840040|S048|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/1995|08/29/1995|||APPR|APPROVAL FOR NEW PTCA CATHETER CREATED BY THE MODIFICATION OF THE SYNERGY II PTCA CATHETER MARKETED UNDER THE TRADE NAME:SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER
P840068|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA PACEMAKER SYSTEM|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1995|11/20/1995|||APPR|APPROVAL FOR ALTERNATE MANUFACTURING SITE FOR ASSEMBLY OF THE EXTERNAL PRODUCTS (PROGRAMMERS, SOFTWARE MODULES/DISKS, EXTERNAL CARDIOVERTER DEFIBRILLATORS, AND RELATED ACCESSORIES) WHICH ARE USED WITH CPI PACEMAKER AND AICD SYSTEMS. THE PROPOSED ALTERNATE MANUFACTURING SITE (CARDIGAN FACILITY) IS LOCATED AT THE FOLLOWING ADDRESS:CPI CARDIGAN FACILITY, 599 CARDIGAN ROAD, SHOREVIEW, MINNESOTA 55126
P850007|S016|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|SPINAL-STIM(R)|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/05/1995|09/19/1996|||APPR|COMPANY PROVIDED FINAL DRAFT LABELING MODIFIED TO REFLECT TO THE LONG-TERM SUCCESS RATES FOR THE DEVICE
P850021|S031|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HYBRID (PTCA) CATHETER|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/12/1995|06/12/1995|||APPR|
P850051|S050|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/1995|05/23/1995|||APPR|
P850064|S011|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/1995|12/18/1995|||APPR|APPPROVAL FOR AN ENDOTRACHEAL TUBE ADAPTER FOR USE WITH THE MODEL 203 LIFE PULSE HIGH FREQUENCY JET VENTILATOR. THE ENDOTRACHEAL TUBE ADAPTOR WILL BE MARKETED UNDER THE NEW TRADE NAME AS THE "LIFEPORT" ENDOTRACHEAL TUBE ADAPTER
P850079|S026|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT KERATOCONUS METHAFILCON B|LPL|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1995|05/15/1995|||APPR|
P850088|S033|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|OXYSEPT 1 & ULTRACARE DISINFECTING SOLUTIONS & OXYSEPT 2 NEUTRALIZING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
P850089|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE Z MODELS 5034/5534/5033 PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/1995|12/21/1995|||APPR|APPROVAL FOR MODELS 5034, 5534, 5033 PACING LEADS - THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES CAPSURE Z MODEL 5-34, 5534, AND 5033 PACING LEADSAND HAVE APPLICATIONS WHERE PERMANENT VENTRICULAR, ATRIAL, OR DUAL CHAMBERED PACING SYSTEMS ARE INDICATED. THE LEADS ARE USED TO PROVIDE CHANNELED, ELECTRICALLY CONDUCTIVE PATHWASY BETWEEN THE PULSE GENERATOR AND THE HEART
P860004|S033|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/1995|06/05/1995|||APPR|
P860004|S034|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1995|05/22/1995|||APPR|
P860019|S099|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED POC BANDIT PTCA CATHETER|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/1995|05/16/1995|||APPR|
P860022|S046|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON EQUALENS(R) AND BOSTON RXD(R)|HQD|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/27/1995|06/05/1995|||APPR|
P860022|S047|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON EQUALENS(R) AND BOSTON RXD(R)|HQD|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/1995|06/05/1995|||APPR|
P860034|S012|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/1995|07/28/1995|||APPR|APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR, STERILIZATION OF LENSES USING PREVIOUSLY APPROVED 100% (ETO) STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE-POUCH/100% ETO STERILIZED LENSES
P860047|S009|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/24/1995|06/09/1995|||APPR|
P870026|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|RESOLVE/GP(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION ISTE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
P870036|S035|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) CORONARY BALLOON DILATATION CATHETERS MODELS 18K, 14K SPIRT, EVERGREEN, FALCON AND PANTHER|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/1995|04/27/1995|||APPR|
P870037|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
P870045|S039|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES MODEL CM22UB|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/1995|10/11/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION CYCLE WITH REVISED PARAMETERS
P880003|S038|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/03/1995|04/27/1995|||APPR|
P880003|S039|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/1995|04/27/1995|||APPR|
P880003|S040|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/1995|04/27/1995|||APPR|
P880003|S041|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1995|05/17/1995|||APPR|
P880003|S042|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/05/1995|06/05/1995|||APPR|
P880003|S043|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/06/1995|06/05/1995|||APPR|
P880003|S044|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/06/1995|06/05/1995|||APPR|
P880003|S045|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/06/1995|06/05/1995|||APPR|
P880003|S046|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/05/1995|05/22/1995|||APPR|
P880003|S047|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/1995|05/22/1995|||APPR|
P880003|S048|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/04/1995|08/14/1995|||APPR|APPROVAL FOR TITAN XL PTCA DILATATION CATHETERS WITH A USABLE LENGTH OF 155CM
P880027|S035|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MICROSOFT(TM) PTCA CATHETERS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1995|05/16/1995|||APPR|
P880065|S002|Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||PULSE-GENERATOR, PROGRAM MODULE|MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER|LOT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/1995|10/23/1995|||APPR|APPROVAL FOR A NEW CONTRACT STERILIZER AND A CHANGE IN THE STERILIZATION PROCEDURE
P880081|S018|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1995|07/28/1995|||APPR|APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR, STERILZATION OF LENSES USING PREVIOUSLY APPROVED 100% ETO STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE POUCH/100% ETO STERILIZED LENSES
P880086|S031|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY(R) CARDIAC PACING SYSTEM|DXY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/1995|06/21/1995|||APPR|
P890003|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(TM) PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/1995|10/31/1995|||APPR|APPROVAL FOR MODIFIED REDUCED SIZE VERSIONS OF THE THERA DR (APPROVED UNDER P890003/S31).  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME:MEDTRONIC THERA-I SERIES AND PRODIGY PULSE GENERATORS, MODEL 9879 SOFTWARE, AND MODELS 9759/9772 MEMORYMODS.
P890003|S038|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(TM) PULSE GENERATORS|DXY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/1995|05/23/1995|||APPR|
P890003|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(R) VDD, MODEL 896I, PRODIGY(TM) VDD, MODEL 8168 PULSE GENERATORS AND CAPURE(R) VDD, MODEL 5032 LEAD,|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/1995|03/22/1996|||APPR|APPROVAL FOR THE MEDTRONIC THERA VDD MODEL 8968I AND PRODIGY VDD MODEL 8168 PULSE GENERATORS, MODEL 5032 CAPSURE VDD LEAD, MODEL 9879E SOFTWARE, AND MODEL 9759 MEMORYMOD
P890003|S040|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC(R) THERA(TM) PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1995|08/15/1995|||APPR|APPROVAL FOR THE MODEL 9877A SOFTWARE DISKETTE WHICH PROVIDES ELECTROPHYSIOLOGY STUDY (EPS) SOFTWARE WITH BACKUP VENTRICULAR PACING
P890032|S021|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/06/1995|05/17/1995|||APPR|
P890048|S004|USCI, DIV. C.R. BARD, INC.|1200 TECHNOLOGY PARK DR.|P.O. BOX 7025|BILLERICA|MA|01821||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/1995|06/14/1995|||APPR|
P890056|S002|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1995|07/28/1995|||APPR|APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR, STERILIZATION OF LENSES USING PREVIOUSLY APPROVED 100% ETO STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE-POUCH/100% ETO STERILIZED LENSES
P890061|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P MODEL 1600|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1995|11/20/1995|||APPR|APPROVAL FOR ALTERNATE MANUFACTURING SITE FOR ASSEMBLY OF THE EXTERNAL PRODUCTS (PROGRAMMERS, SOFTWARE MODULES/DISKS, EXTERNAL COARDIOVERTER DEFIBRILLATORS, AND RELATED ACCESSORIES) WHICH ARE USED WITH CPI PACEMAKER AND AICD SYSTEMS. THE PROPOSED ALTERNATE MANUFACTURING SITE (CARDIGAN FACILITY) IS LOCATED AT THE FOLLOWING ADDRESS: CPI CARDIAGAN FACILITY, 599 CARDIGAN ROAD, SHOREVIEW, MINNESOTA 55126
P900022|S004|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|CHORUS(R) MODEL 6001,3,33 DDD MODEL CPRI MODEL P2A|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/1995|05/16/1995|||APPR|
P900023|S015|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/1995|06/22/1995|||APPR|
P900043|S002|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/1995|05/01/1996|||APPR|APPROVAL FOR REVISED DEVICE LABELING
P900047|S003|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK(TM) REWETTING DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THEUSE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
P900056|S011|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/1995|01/18/1996|||APPR|APPROVAL FOR THE REMOVAL OF THE DRIVESHAFT DISTAL HEATSHRINK
P900061|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/1995|04/27/1995|||APPR|
P910016|S005|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE|MBD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1995|12/13/1995|||APPR|APPROVAL OF MINIMUM DOSE GAMMA IRRADIATION VALIDATION FOR POLYETHYLENE COMPONENTS
P910016|S006|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE|MBD|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/1995|12/13/1995|||APPR|APPROVAL OF ETHYLENE OXIDE STERILIZATION FOR POLYETHYLENE COMPONENTS
P910023|S010|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1995|04/27/1995|||APPR|
P910073|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/1995|05/16/1995|||APPR|
P910073|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/1995|06/07/1995|||APPR|
P910073|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/1995|11/27/1995|||APPR|APPROVAL FOR THE DECREASE IN THE LEAD BODY DIAMETER TO BE A MAXIMUM DIAMETER OF 10 FRENCH AND MODIFICATIONS IN THE LEAD COMPONENTS - THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK DSP LEAD MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125
P910075|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COMPLETE BRAND LUBRICATING AND REWETTING DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1995|12/05/1995|n  -||APPR|APPROVAL FOR THE FOLLOWING ALTERNATE MANUFACTURING SITE:ALLERGAN AMERICA, PUERTO RICO ROAD 345 KM 1.5, HORMIGUEROS, PUERTO RICO, 00660
P910075|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) REWETTING DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1995|04/12/1996|||APPR|APPROVAL FOR ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
P910077|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX (TM) II AICD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1995|11/20/1995|||APPR|APPROVAL FOR ALTERNATE MANUFACTURING SITE FOR ASSEMBLY OF THE EXTERNAL PRODUCTS (PROGRAMMERS, SOFTWARE MODULES/DISKS, EXTERNAL CARDIOVERTER DEFIBRILLATORS, AND RELATED ACCESSORIES) WHICH ARE USED WITH DPI PACEMAKER AND AICD SYSTEMS. THE PROPOSED ALTERNATE MANUFACTURING SITE (CARDIGAN FACILITY) IS LOCATED AT THE FOLLOWING ADDRESS: CPI CARDIGAN FACILITY, 599 CARDIGAN ROAD, SHOREVIEW, MINNESOTA 55126
P930029|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR(TM) RFCA SYSTEM|LPB|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|04/14/1995|05/25/1995|||APPR|
P930035|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AICD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1995|11/20/1995|||APPR|APPROVAL FOR ALTERNATE MANUFACTURING SITE FOR ASSEMBLY OF EXTERNAL PRODUCTS (PROGRAMMERS, SOFTWAE MDULES/DISKS, EXTERNAL CARDIOVERTER DEFIBRILLATORS, AND RELATED ACCESSORIES) WHICH ARE USED WITH CPI PACEMAKER AND AICD SYSTEMS. THE PROPOSED ALTERNATE MANUFACTURING SITE (CARDIGAN FACILITY) IS LOCATED AT THE FOLLOWING ADDRESS: CPI CARDIGAN FACILITY, 599 CARDIGAN ROAD, SHOREVIEW, MINNESOTA 55126
P820076|S020|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|BIOTRONIK GEMNOS 04, 04A, AND TC 04|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/04/1995|12/22/1995|||APPR|APPROVAL FOR THE CHANGE IN THE BURN-IN PROCESSING OF THE WILSON GREATBATCH BATTERIES WHICH ARE USED IN YOUR LISTED PACEMAKERS. THIS PROCESS CHANGE IS A REDUCTION OF THE BATTERY BURN-IN TIME FROM 35 DAYS TO 4 DAYS
P870018|S010|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1995|07/13/1995|||APRL|APPROVAL FOR A MODIFIED IMAGE INTENSIFIER TO BE USED WITH THE LITHOSTAR SYSTEM
P810002|S036|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/05/1995|11/28/1995|||APPR|APPROVAL FOR A ROTATABLE VERSION OF THE ST.JUDE MEDICAL MECHANICAL HEART VALVE - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME:ST. JUDE MEDICAL MASTER SERIES AND WILL BE AVAILABLE IN THE FOLLOWING MODEL NUMBERS AND SIZES:AJ-501 AND AECJ-502 (19, 21, 23, 25, 27, 29, AND 31 MM), MJ-501 AND MECJ-502 (19, 21, 23, 25, 27, 29, 31, AND 33MM) AND AHPJ-505, MHPJ-505, AEJPJ-506, AND MEHPJ-506 (17, 19, 21, 23, 25, AND 27MM). THE SUPPLEMENT ALSO INCLUDES A VALVE HOLDER/ROTATOR ACCESSORY WHICH WILL BE INCLUDED AS A COMPONENT OF THE MECHANICAL HEART VALVE SIZER SET MODEL 905
P830034|S027|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/1995|09/26/1995|||APPR|APPROVAL TO MODIFY THE LABELING FOR THE OPTI-ONE MULTI-PURPOSE SOLUTION BY EXPANDING THE APPROVAL FOR INDICATIONS FOR USE
P910073|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/1995|04/04/1996|||APPR|ALTERNATIVE MANUFACTURING SITE: CARDIAC PACEMAKERS, INC., DEL CARIBE, ROAD 698 LOT NO. 12, DORADO, PUERTO RICO  00646
P880098|S008|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, extended wear|MENICON SF-P (MELAFOCON A) CONTACT LENS|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/1995|06/23/1995|||APPR|
P820075|S006|Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL(R) OSSMOTIC CERVICAL DILATOR|LOB|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/1995|10/10/1995|||APPR|APPROVAL FOR NEW ACCELERATED TESTING PROTOCOL TO ESTABLISH THE SHELF-LIFE OF YOUR PRODUCT TO 24 MONTHS
P880072|S026|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1995|07/24/1995|||APPR|APPROVAL FOR MODELS GS55A-OUV & GS55B-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOLS AS TIER A MODIFICATIONS OF MODEL PA90E-2UV AND FOR IMPLANTATION IN THE CAPSULAR BAG ONLY
P820021|S027|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES|LPM|OP|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/1995|06/28/1995|||APPR|
P910023|S011|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1995|10/31/1995|||APPR|APPROVAL FOR THE PROGRAMMER SOFTWARE VERSION 4.0 WITH THE CADENCE MODELS V-100, V-110 OR V-112 IMPLANTABLE DEFIBRILLATOR
P850057|S005|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CUSTOMEYES(TM) 45L&55L (BUFILCON A)|LPM|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/1995|09/22/1995|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS USING ULTRAVIOLET LIGHT INITIATOR IN THE MODIFIED CURE PROCESS FOR BUFILCON A (55% WATER) CONTACT LENSES
N17752|S036|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE (BUFILCON A CONTACT LENSES)|LPL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/1995|09/22/1995|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS USING ULTRAVIOLET LIGHT INITIATOR IN THE MODIFIED CURE PROCESS FOR BUFILCON A (55% WATER) CONTACT LENSES AS REFERENCED ABOVE
P890043|S030|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1995|06/12/1995|||APPR|
P910073|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1995|08/14/1995|||APPR|APPROVAL FOR THE MODEL 6946 LEAD REPAIR KIT.
P880027|S036|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1995|11/21/1995|N||APPR|APPROVAL FOR THE FOLLOWING:1)NEW LABELING WHICH COMPLIES TO THE FDA'S PTCA PACKAGE INSERT TEMPLATE 2)ALTERNATIVE PACKAGING DESIGN AND MATERIALS 3)A CHANGE IN THE MATERIAL OF THE PROXIMAL TO DISTAL INNER MEMBER TRANSITION SLEEVE 4)ADDITION OF 2.25, 2.75, 3.25, AND 3.75 MM BALLOONS WITH LENGTHS OF 20, 30, AND 40MM 5)AN INCREASE IN THE INNER AND OUTER DIAMETERS OF THE PROXIMAL SHAFT AND DISTAL STEM OF THE CATHETERS HAVING 20 MM BALLOONS 6)AN ALTERNATIVE DESIGN CONFIGURATION WHICH PLACES THE SHAFT TO STEM BOND DISTAL TO THE INNER MEMBER HYPOTUBE TRANSITION, NOT PROXIMAL
P880072|S027|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/1995|07/24/1995|||APPR|APPROVAL FOR MODELS LP50A-OUV, PB06B-OUV, & PB05A-OUV AS TIER A MODIFICATIONS OF A PREVIOUSLY APPROVED MEDICAL DEVELOPMENTAL RESEARCH, INC., PARENT IOL
P880042|S002|EDAP INTERNATIONAL CORP.|179 SIDNEY ST.||CAMBRIDGE|MA|02139||Lithotriptor, extracorporeal shock-wave,urological|EDAP LT.02 SHOCK WAVE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1995|12/18/1996|||APPR|APPROVAL FOR A NEW MODEL LITHOTRIPTER, TO BE MANUFACTURED AT THE VAULX-EN-VELIN (FRANCE) FACILITY.
P880027|S037|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER FREEHAND(R) PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/22/1995|07/31/1995|||APPR|APPROVAL FOR ADDITIONAL QUARTER SIZE MODELS OF THE MC RAIL, MYSTIC, & FREEHAND CATHETER LINES
P900060|S011|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1995|08/12/1996|||APPR|APPROVAL FOR THE 21MM MITRAL CPHV, MODEL M700
P910054|S001|Toray Industries (America), Inc.|461 FIFTH AVENUE, 9TH FLOOR||NEW YORK|NY|10017||CATHETER, PERCUTANEOUS (VALVULOPLASTY)|INOUE BALLOON CATHETER|MAD|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/1995|11/30/1995|||APPR|APPROVAL FOR A MODIFICATION OF THE STERILIZATION CYCLE
P830055|S043|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1995|01/02/1996|||APPR|APPROVAL OF GAS PLASMA STERILIZATION FOR POLYETHYLENE COMPONENTS
P820075|S007|Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL(R) OSMOSTIC CERVICAL DILATOR|LOB|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/1995|01/03/1996|||APPR|APPROVAL FOR RELOCATING CABOT'S LAMICEL PROCESSING EQUIPMENT AND THE ASSOCIATED METHODS OR PROCEDURESTO THE MEROCEL FACILITY AT 950 FLANDERS ROAD, MYSTIC, CONNECTICUT, 06355
N18331|S025|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED|NEW|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/24/1995|11/02/1995|||APPR|APPROVAL FOR USE OF THE PDS II SUTURE IN HTE PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
P910016|S007|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE|MBD|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/1995|01/02/1996|||APPR|APPROVAL OF GAS PLASMA STERILIZATION FOR POLYETHYLENE COMPONENTS
P880072|S028|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/1995|07/24/1995|||APPR|APPROVAL FOR MODELS LP50A-OUV, PB06B-OUV, PB05A-OUV AS TIER A MODIFICATIONS OF A PREVIOUSLY APPROVED MEDICAL DEVELOPMENTAL RESEARCH INC. PARENT IOL
P880072|S029|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/1995|07/24/1995|||APPR|APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENS MODEL RM60D-2UV
P880072|S030|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/1995|08/24/1995|||APPR|RESPONSE TO FDA'S LETTER OF APRIL 28, 1995, RE:YOUR 1992 AND 1993 ANNUAL REPORTS & REQUESTED TIER A APPROVAL FOR MDLS:GL55A-OUV, GL55B-OUV,PS40D-OUV,PS60C-OUV,PB61B-OUV,PB07C-OUV & LP57L-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOLS
P900013|S001|Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK,|IL|60064|3537|KIT, ASSAY, PROGESTERONE RECEPTOR|ABBOTT PGR-EIA MONOCLONAL|LPI|CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/1995|07/07/1995|||APPR|MINOR LABELING CHANGES TO ASSIST USERS IN AVOIDING INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION,ADDING REFERENCE ON THE EFFECT OF METHYLENE BLUE ON ESTROGEN RECEPTORS
P850029|S001|Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK,|IL|60064|3537|KIT, ASSAY, ESTROGEN RECEPTOR|ABBOTT ER-EIA MONOCLONAL DIAG. KIT|LPJ|CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/1995|07/12/1995|||APPR|MINOR LABELING CHGS TO ASSIST USERS TO AVOID INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION, INSTRUCTIONS TO REPORT PRESENCE OR ABSENCE OF SURGICAL DYES
N18020|S040|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/1995|09/20/1995|||APPR|APPROVAL FOR A REVISED PACKAGE INSERT TEXT WHICH IS TO BE PRINTED ON THE 8 FL. OZ AND 15 FL. OZ. AEROSOL CANS OF THE REFERENCED DEVICE AND THE ELIMINATION OF THE PACKAGE INSERT FOR THESE SIZE CONTAINERS
P880072|S032|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/18/1995|07/24/1995|||APPR|APPROVAL FOR MODELS LP50A-OUV, PBO6B-OUV, & PBO5A-OUV AS TIER A MODIFICATIONS OF A PREVIOUSLY APPROVED MEDICAL DEVELOPMENTAL RESEARCH, INC. PARENT IOL
P880072|S033|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/17/1995|07/24/1995|||APPR|APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENS MODEL CS55B-OUV
P860047|S010|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE)|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/31/1995|07/18/1995|||APPR|APPROVAL FOR CHANGE IN LABELING
P880003|S049|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/1995|09/18/1995|||APPR|APPROVAL FOR A NEW PACKAGING TRAY MATERIAL (ACRYLIC XT POLYMER)
P900061|S011|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/1995|08/01/1995|||APPR|APPROVAL FOR TECOTHANE 75D POLYURETHANE RESIN IN MEDTRONIC IMMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P890047|S007|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|DUOVISC VISCOELASTIC SYSTEM|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/1995|08/02/1995|||APPR|APPROVAL FOR A MODIFICATION TO THE DUOVISC PACKAGE INSERT TO ALLOW FOR THE USE OF BOTH DEVICES IN A SINGLE OPHTHALMIC PROCEDURE
P900061|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/1995|08/22/1995|||APPR|APPROVAL FOR MEDTRONIC, INC., MED-REL, ROAD 909, KM. 0.4., BARRIO MARIANA, HUMACAO, PUERTO RICO, TO MANUFACTURE THE MODEL 7220 B/D/E JEWEL PLUS ARRHYTHMIA CONTROL SYSTEM
P900029|S001|CIBA VISION CORPORATION|2910 AMWILER CT.||ATLANTA|GA|30360||Accessories, soft lens products|NDS LENS MAINTENANCE SYSTEM|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1995|08/01/1995|||APPR|APPROVAL FOR LABELING CHANGES TO ENHANCE THE INSTRUCTIONS TO BETTER COMMUNICATE THE PROPER LENS STORAGE TIMEFRAMES WHEN USING THE QUICK CARE SYSTEM.
P910031|S003|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|CATHSCANNER ORACLE MICRO PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/1995|12/07/1995|||APPR|APPROVAL  FOR THE ENDOSONICS ORACLE FOCUS PTCA CATHETER, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ENDOSONICS ORACLE FOCUS PTCA CATHETER
P840064|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DUOVISC VISCOELASTIC SYSTEM|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/1995|08/02/1995|||APPR|APPROVAL FOR A MODIFICATION TO THE DUOVISC PACKAGE INSERT TO ALLOW FOR THE USE OF BOTH DEVICES IN A SINGLE OPHTHALMIC PROCEDURE
P860061|S010|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRAZYME(R) ENZYMATIC CLEANER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1995|10/11/1995|||APPR|APPROVAL FOR USE OF DEVICE (SMALL TABLET FORMULATION) IN LENS CASES WITH VOLUMES RANGING FROM 1.8ML TO 4ML PER WELL
N50510|S069|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1995|08/07/1996|||APPR|APPROVAL FOR REMOVAL OF LIMITATION FOR SUSCEPTIBILITY TESTING OF ENTEROCOCCI/VANCOMYCIN TESTING ON THE VITEK GENERAL SUSCEPTIBILITY CARD
P900059|S003|MOLECULAR BIOSYSTEMS, INC.|10030 BARNES CANYON RD.||SAN DIEGO|CA|92121||Contrast media, ultrasound|ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES|MJS|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/1995|08/28/1995|||APPR|APPROVAL FOR RELEASE OF FINAL PRODUCT BASED ON RESULTS FROM KINETIC QUANTITATIVE CHROMOGENIC LAL BATERIAL ENDOTOXIN TEST AND REPLACEMENT OF TAII COULTER COUNTER WITH MULTISIZER IIE COULTER COUNTER FOR PARTICLE SIZE MEASUREMENT
P880003|S050|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TRASKAR 18 PTCA DILITATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1995|12/05/1995|||APPR|APPROVAL FOR A MODIFICATION OF THE EXIT MARKER MATERIAL AND APPLICATION PROCESS
P850088|S034|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICES
P900047|S004|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK(TM) REWETTING DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICE
P870054|S014|COOK PACEMAKER CORP.|ROUTE 66 RIVER RD.|P.O. BOX 529|LEECHBURG|PA|15656||implantable pacemaker Pulse-generator|KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1995|07/12/1995|||APPR|APPROVAL FOR A CHANGE IN THE ACCELERATED BURN-IN PROCEDURE ON THE LITHIUM/IODINE POWER SOURCE (BATTERY) BY THE VENDOR
P800065|S015|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LENS-WET(TM)|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CPAS USED IN THE MANUFACTURE OF THE DEVICE
P870037|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|WET-N-SOAK|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, ITPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICES
P870026|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|RESOLVE/GP(TM) DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR THE STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATIN SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICE
P910075|S006|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) REWETTING DROPS|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICE
N17786|S025|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS
N18020|S041|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE SUE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS USED IN THE MNAUFACTURE OF THE DEVICE
P790024|S025|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|LC-65 (R) DAILY CONTACT LENS CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/1995|02/23/1996|||APPR|APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICE
P790002|S016|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1995|04/09/1996|||APPR|CHANGES TO LABELING INCLUDING THE ADDITION OF INFORMATION REGARDING "TREATMENT COMPLETION," (AFFECTS PHYSICIAN INSTRUCTION MANUAL), A DESCRIPTION OF THE PMA POPULATION AND ORIGINAL AND FOUR YEAR SUCCESS RATES (AFFECTS PHYSICIAN INSTRUCTION AND PATIENT MANUALS) AND THE ADDITION OF A CONTRAINDICATION FOR PATEINTS WEARING IMPALNTABLE DEFIBRILLATORS (AFFECTS PHYSICIAN INSTRUCTION MANUAL)
P910064|S011|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/1995|11/16/1995|||APPR|APPROVAL FOR A CHANGE IN THE TYPE OF PACKAGING USED TO SUPPLY THE EXTRA LUBRICANT THAT IS SOLD WITH REALITY
P860019|S100|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|LEAP EXPRESS PLUSS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1995|08/17/1995|||APPR|NEW PTCA CATHETER BASED ON 4 MODIFICATIONS TO SCIMED EXPRESS PLUS II PTCA CATHETER:ADDTION OF LEAP BALLOON MATERIAL,THINNER BALLOON MARKER BAND,ORANGE MANIFOLD,II WILL BE DROPPED FROM NAME TRADE NAME:SCIMED LEAP EXPRESS PLUS PTCA CATHETER
P820001|S018|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-FREE(R) SUPRA-CLENS DAILY PROTEIN REMOVER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1995|12/28/1995|||APPR|APPROVAL FOR A PANCREATIN-BASED LIQUIED ENZYMATIC CLEANER - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME:OPTI-FREE SUPRA-CLENS DAILY PROTEIN REMOVER
P910077|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI AICD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/13/1995|12/21/1995|||APPR|APPROVAL FOR THE VENTAK MINI AICD SYSTEM, WHICH INCLUDES:MODEL NUMBERS 1645, 1740, 1741, 1745, AND 1746 PULSE GENERATORS; MODEL 2840 SOFTWARE APPLICATION; MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU); AND MODEL 6996 DF-1 PLUG
P890034|S005|Covidien|6135 GUNBARREL AVE.||BOULDER|CO|80301||VENTILATOR, HIGH FREQUENCY|MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1995|12/28/1995|||APPR|APPROVAL FOR AN PROXIMAL MONITORING ENDOTRACHEAL TUBE ADAPTER FOR USE WITH THE ADULT STAR MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR - THE PROXIMAL MONITORING ADAPTER WILL BE MARKETED UNDER THE NEW TRADE NAME AS THE "PROXIMAL MONITORING ADAPTER"
P850048|S011|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY|LTJ|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/14/1995|11/06/1995|||APPR|APPROVAL FOR INCLUSION OF INFORMATION AND ATA ON PSA FORMS IN THE TANDEM PSA LABELING
P830079|S011|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/13/1995|07/07/1995|||APPR|APPROVAL TO MARKET INSTAT COLLAGEN ABSORABLE HEMOSTAT (ALL SIZES) FOR ENDOSCOPIC PROCEDURES
P880082|S018|EYETECH, LLC.|7016 6TH ST. NORTH||OAKDALE|MN|55128||intraocular lens|CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/1995|09/28/1995|||APPR|APPROVAL FOR THE USE OF A NEW CLEANING AGENT
P830055|S044|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1995|12/28/1995|||APPR|APPROVAL FOR THE ADDITION OF SMALL AND SMALL+ SIZED BEARING COMPONENTS
P850007|S017|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|SPINAL-STIM(R) MODEL 8212C|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/1995|01/09/1997|||APPR|APPROVAL FOR THE MODEL 8000C CONTROL UNIT WHICH IS TO BE USED IN CONJUNCTION WITH THE EXISTING MODEL 212 TREATMENT TRANSDUCERS, AND FOR MINOR MODIFICATIONS TO THE LABELING OF THE PHYSICIAN MANUAL REGARDING PATIENT COMPLIANCE DATA RETRIEVAL AND ERASURE. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPINAL-STIM(R) AND IS INDICATED AS A SURGICAL ADJUNCT FOR SPINAL FUSION OR AS A NONOPERATIVE TREATMENT WHERE AT LEAST NINE MONTHS HAVE ELAPSED SINCE THE LAST SURGERY.
P910077|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX(R) AICD(TM) SYSTEM FOR PECTORAL REPLACEMENT OF VENTAK PRXIII PULE GENERATOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/14/1995|03/14/1996|||APPR|APPROVAL FOR SUBPECTORAL IMPLANTATION OF THE VENTAK PRX III PULSE GENERATOR
P830066|S012|Abbott Laboratories|DEPT: 09V8 BLDG: AP5-2|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064|3500|SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|ABBOTT CEA-RIA MONOCLONAL|DHX|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/14/1995|07/12/1995|||APPR|APPROVAL FOR MODIFICATION OF THE PACKAGE LABELING TO DECREASE THE "HOOK" VALUE FROM 100,00 TO 60,000 NG CEA/ML
P880028|S003|Hospira, Inc.|275 NORTH FIELD DR.|DEPT. 389, BLDG. H2-2|LAKE FOREST|IL|60045||FLUID, HYSTEROSCOPY|DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM|LTA|OB|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/19/1995|12/15/1995|||APPR|APPROVAL FOR DELETING THE TEST FOR ANTIGENIC IMPURITIES IN THE TESTING SPECIFICATIONS FOR THE DEXTRAN 70 (CODE 59479) BULK DRUG SUBSTANCE
P910077|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX (TM) II AICD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/1995|02/05/1996|||APPR|APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR AICD MODELS:1705, PRX II MODEL 1715, AND PRX III MODELS 1720/1725, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE
P840068|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/1995|04/16/1996|||APPR|APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE CARDIAC PACEMAKER MODELS, PELLETHANE 2363-75D POLYURETHANE WITH TECOTHANE TT1075D-M POLYURETHANE
P890061|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P MODEL 1600|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/1995|02/20/1996|||APPR|APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE AICD MODEL, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE
P930035|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P3 AICD(TM) SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/1995|02/20/1996|||APPR|APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE AICD MODELS, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE
P940031|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR(TM) DR PACEMAKER SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/1995|02/20/1996|||APPR|APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE PULSE GENERATOR MODELS, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE
P900061|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL(TM) MODELS 7219 B/D/E, 7202 B/D/E JEWEL PLUS 7220 B/D/E|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/1995|04/15/1996|||APPR|APPROVAL FOR MODEL 7219 B/D/E JEWEL(TM), MODEL 7202 D/E/ JEWEL(TM), MODEL 7220 B/D/E JEWEL PLUS DEVICE WITH ENDOTAK SERIES LEADS
P900052|S003|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST|LNY|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/1995|12/21/1995|||APPR|APPROVAL FOR THE ADDITION OF A 16 GAUGE, THIN-WALL INTRODUCER NEEDLE (MANAN EPIDURAL NEEDLE (K852428)) TO THE PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
P880072|S034|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/1995|08/24/1995|||APPR|TIER A APPROVAL FOR MODEL PL52B-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOL
P820021|S028|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/27/1995|03/18/1996|||APPR|APPROVAL FOR AN AUTOMATED MANUFACTURING LINE AND PROCESS FOR FOCUS AND NEWVUES (VIFILCON A) SOFT (HYDROPHILIC( CONTACT LENSES
P920015|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) MODEL 6937 TRANSVENE SVC LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/1995|03/22/1996|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 6937 TRANSVENE SUPERIOR VENA CAVA LEAD
P840001|S038|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 7495, ITREL II PERMANENT EXTENSION|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/1995|12/06/1995|||APPR|APPROVAL FOR THE USE OF SEALING RINGS IN THE MODEL 7495 PERMANENT EXTENSION
P890032|S022|CORDIS CORP.|P.O. BOX 025700||MIAMI|FL|33102|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS ORION STEERABLE PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1995|10/31/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE (ISOMEDIX NORTHBOROUGH, MASSACHUSETTS
P900056|S012|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/1995|01/29/1996|||APPR|APPROVAL FOR THE ROTAWIRE GUIDE WIRE LINE
P810002|S037|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MECHANICAL HEART VALVE SJM(R) MASTER SERIES|LWQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/1995|08/11/1995|||APPR|APPROVAL FOR THE USE OF PROOF TESTING IN THE EVALUATION OF ST.JUNDE MEDICAL MECHANICAL HEART VALVES CONSTRUCTED WITH CARBOMEDICS, INC. MANUFACTURED COMPONENTS.
P860019|S101|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|LEAP EXPRESS PLUSS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/05/1995|08/22/1995|||APPR|APPROVAL TO CHANGE THE SCIMED EXPRESS PLUS II PTCA CATHETER'S NAME TO POC EXPRESS PLUS AND TO MODIFY THE LABELING TO BE CONSISTENT WITH THE OTHER PTCA CATHETERS UNDER P860019
P840024|S058|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/1995|01/24/1996|||APPR|APPROVAL FOR THE MODIFICATION OF THERAPEUTIC CLAIMS OF DEVICE EFFECTIVENESS FOR ADULT USERS OF THE NUCLEUS 22-CHANNEL COCHLEAR IMPLANT
P830063|S001|BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER|MDP|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/1995|08/28/1996|||APPR|APPROVAL FOR A CHANGE OF MATERIAL USED IN THE HOUSING OF THE DEVICE, END CAP CONFIGURAITON MODIFICATION AND SPECIFICATION CHAGNES TO THE DEVICE MEMBRANE (I.E., DECREASE IN NUMBER OF HOLLOW FIBERS AND INCREASE IN HOLLOW FIBER LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER AND IS INDICATED FOR USE IN THERAPEUTIC PLASMAFILTRATION IN DISEASES WHERE REMOVAL OF PLASMA COMPONENTS ARE INDICTED, INCLUDING PLASMAFILTRATION PROCEDURESWHERE FILTERED PLASMA IS REINFUSED
P910023|S012|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/1995|12/22/1995|||APPR|APPROVAL FOR CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM WITH "C" AND "D" HEADER STYLES FOR CADET V-105 AND V-115, AND PROGRAMMER MODEL PR-1500 SOFTWARE VERSION 4.1
P860019|S102|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETERS AND TRAPPER EXCHANGE DEVICE|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/1995|11/20/1995|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY AT SCIMED LIFE SYSTEMS, INC., 6655 WEDGEWOOD RD., MAPLE GROVE, MINNESOTA; AND THE MANUFACTURE OF THE TRAPPER PTCA EXCHANGE DEVICE IN A NON-CLEANROOM ENVIORNMENT
P920021|S001|BEHRING DIAGNOSTICS, INC.|151 UNIVERSITY AVE.||WESTWOOD|MA|02090||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|OPUS(R) CEA TEST SYSTEM|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/03/1995|02/23/1996|||APPR|APPROVAL TO ADD THE CEA TEST SYSTEM TO THE OPUS PLUS AND OPUS MAGNUM ANALYZERS. THE SAME TEST SYSTEM IS USED ON ALL THREE INSTRUMENTS
P900061|S014|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/03/1995|12/06/1995|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN ARRHYTHMIA MANAGEMENT SYSTEMS. THE MODEL 7220C WAS WITHDRAWN FROM THE REFERENCED APPLICATION, AND THEREFORE APPROVAL IS NOT GRANTED FOR THAT MODEL
P880003|S051|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIA PTCA DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/1995|12/06/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE (ISOMEDIX) NORTHBOROUGH, MASSACHUSETTS
P800036|S032|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/1995|12/30/1996|||APPR|APPROVAL FOR THE STRATO/INFUSAID PRIMING KIT, AN ACCESSORY TO THE INFUSAID IMPLANTABLE INFUSION PUMP.
P860019|S103|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|LEAP EXPRESS PLUSS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/1995|08/15/1995|||APPR|APPROVAL FOR ADDITION OF QUARTER SIZE BALLOONS TO THE SCIMED BANDIT, SCIMED LONG BANDIT 30, AND THE SCIMED LONG BANDIT 40 PTCA CATHETER LINES
P850051|S051|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1995|10/31/1995|||APPR|APPROVAL FOR THE ADDITION OF THREE MODELS OF PULSE GENERATORS TO YOUR ACTIVITRAX CARDIAC PACING SYSTEM. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAEM OF PREVAIL (MODELS 8084, 8085, AND 8086) USING MODEL 9885E SOFTWARE WITH THE ALREADY APPROVED PROGRAMMERS MODELS 9760 AND 9790, AND MOMORYMOD MODEL 9773 FOR USE WITH THE ALREADY APPROVED MODEL 9710A PROGRAMMER.
P870015|S021|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/1995|09/15/1995|||APRL|APPROVAL FOR THE FOLLOWING MODIFICATIONS:USE OF ALTERNATE ULTRASOUND IMAGING UNIT; USE OF ALTERNATE DIGITIZER PAD; MODIFICATION OF SYSTEM SOFTWARE TO VERSION 7.10; AND REVISIONS TO SYSTEMS USER'S MANUAL
P920015|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/1995|08/17/1995|||APPR|APPROVAL TO ELIMINATE CFC TO MANUFACTURE THE REFERENCED DEFIBRILLATION LEADS
P900061|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL ACTIVE CAN & JEWEL PLUS ACTIVE CAN ARRHYTHMIA MGMT SYSTEMS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/1995|08/17/1995|||APPR|APPROVAL TO ELIMINATE CFC TO MANUFACTURE THE REFERENCED DEFIBRILLATION LEADS
P900061|S016|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 5420 PATIENT CABLE|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/1995|08/01/1995|||APPR|APPROVAL FOR MODEL 5420 PATIENT CABLE TO BE USED WITH MEDTRONIC, INC.'S IMPLANTABLE DEFIBRILLATORS
P810020|S004|SMITH & NEPHEW RICHARDS, INC.|1450 BROOKS RD.||MEMPHIS|TN|38116||BONE CEMENT|PALACOS E-FLOW (OSTEOPAL) BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/1995|07/30/1998|||APPR|Approval for changes in the bone cement composition.  The device, as modified, will be marketed under the trade name Osteopal (E-Flow) and is indicated for use as a bone cement in arthroplastic procedures of the hip, knee, and other joins to fix plastic and metal prosthetic parts to living bone when recondstruction is necessary because of osteoarthritis, nonunion of fractures of the neck of the femur, sickle cell anemai, osteoporosis, secondary severe joint destruction following trauma or toehr conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
P860019|S104|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NC BANDIT PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/1995|10/02/1995|||APPR|APPROVAL FOR 15 MM LENGTH NC BANDIT PTCA CATHETER LINE
P920051|S001|KARL STORZ ENDOSCOPY-AMERICA, INC.|1201 ROBERTS BLVD.||KENNESAW|GA|30144|||STORZ MODULITH (TM) LITHOTRIPTER||GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/1995|12/19/1995|||APRL|APPROVAL FOR AMOBILE VERSION OF THE STORZ MODULITH LITHOTRIPTER, MODEL SL20
P840062|S006|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS|LPG|DE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/1995|09/08/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY FOR COLLACOTE, COLLATAPE AND COLLAPLUG DRESSINGS AT FRIFFITH MICROSCIENCE, INC., 27 PARK ROAD, GLEN FALLS, NY 12801
P880072|S035|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODEL PS50C-OUV|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/1995|08/07/1995|||APPR|REQUESTED APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENS MODEL PS50C-OUV
P850010|S015|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/1995|09/12/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY FOR HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT AT GRIFFITH MICROSCIENCE, INC. 27 PARK ROAD, GLEN FALLS, NY 12801
P810006|S019|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/1995|09/12/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY FOR COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE AT GRIFFITH MICROSCIENCE, INC. 27 PARK ROAD, GLEN FALLS, NY 12801
P820040|S033|CIBA VISION CARE|11460 JOHNS CREEK PKWY.||DULUTH|GA|30136|1518|Accessories, soft lens products|AOSEPT DISINFECTANT|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/27/1995|12/13/1995|||APPR|APPROVAL FOR LABELING MODIFICATIONS IN THE PACKAGE INSERT
P860019|S105|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED NC EXPRESS PLUS HD PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/1995|10/31/1995|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXPRESS PLUS II CATHETER LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES:NC EXPRESS PLUS & NC EXPRESS PLUS HD
P910023|S013|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1995|05/13/1996|||APPR|APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS AND USE OF EASY-TO-RETRIEVE BIOLOGICAL INDICATORS
P880086|S032|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY III AND PARAGON III DUAL-CHAMBER PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/1995|11/01/1995|||APPR|APPROVAL FOR ALTERNATIVE HYBRID SUBSTRATE
P880086|S033|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TRILOGY PULSE GENERATOR MODELS 235OL, 2250L, AND 2308L|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/1995|11/01/1995|||APPR|APPROVAL FOR ALTERNATIVE HYBRID SUBSTRATE
P900039|S008|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT(TM) BONE GRAFT MATRIX|MBS|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/1995|10/30/1995|||APPR|APPROVAL FOR MODIFICATIONS OT THE PRODUCT LABELING PERTAINING TO POLYMYOSITIS(PM)/DERMATOMYOSITIS(DM)
P920015|S007|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) MODEL 6934S TRANSVENE RV LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/1995|03/13/1996|||APPR|APPROVAL FORTHE MEDTRONIC MODEL 6934S TRANSVENE RIGHT VENTRICULAR LEAD
N18331|S026|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED|NEW|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1995|09/07/1995|||APPR|APPROVAL FOR A CHANGE IN THE STERILIZATION PROCESS FROM USE OF ETHYLENE OXIDE/FREON GAS MIXTURE OR ETHYLENE OXIDE/NITROGEN MIXTURE TO ETHYLENE OXIDE/OXYFUME GAS MIXTURE
P840001|S039|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL II SPINAL CORD STIMULATION SYSTE, INCLUDING A BIFURCATED Y-EXTENSION|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1995|02/28/1997|||APPR|APPROVAL FOR A Y-EXTENSION (MODEL 7498) AND Y-SCREENING CABLE (MODEL 3552).
P940031|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR DR PACEMAKER SYSTEM; VIGOR DR MODEL 1230||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1995|02/26/1996|||APPR|APPROVAL FOR ADDING AN ALTERNATE LOWER PROFILE CONNECTOR TOP FOR THE VIGOR DR MODEL 1230 PACEMAKERS
P800049|S007|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|IRIDOCAPSULAR INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
P870007|S009|OPTOPICS LABORATORIES CORP.|32 MAIN ST., P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|SORBIC ACID PRESERVED SALINE SOL.PH CHANGE|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/1995|09/20/1995|||APPR|APPROVAL FOR MODIFICATION OF THE STABILITY SPECIFICATIONS FOR SORBIC ACID CONCENTRATION FROM A RANGE OF 0.80 MG/ML - 1.20 MG/ML TO 0.70 MG/ML - 1.20 MG/ML
P880010|S018|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIMEA ND THEESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
P880087|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|n||APPR|APPROVAL FOR AN ALTERNATE STERILIZTION PROCESS INCLUDING AERATIO TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
P820035|S014|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
P810001|S012|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
P840068|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA PACEMAKER SYSTRM; VIGOR DDD MODEL 950 (MASTER)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1995|03/12/1996|||APPR|APRPOVAL FOR ADDING AN ALTERNATE LOWER PROFILE CONNECTOR TOP FOR THE VIGOR DDD MODEL 950 PACEMAKER
P810032|S048|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|UV ABSORBING POST.CHAM.IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
P830040|S025|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
P810018|S035|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|UV ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
P840060|S024|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1995|12/13/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATIO PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOL9OGICAL INDICATOR INCUBATION TIME
P900061|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODELS 7200B/C/D/E|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1995|05/07/1996|||APPR|APPROVAL FOR MEDTRONIC MODELS 7220B/C/D/E WITH MODIFIED MICROPROCESSOR
P850051|S052|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC SINGLE CHAMBER PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1995|03/13/1996|||APPR|APPROVAL FOR A STERILIZATION PROCESS CHANGE
P900061|S018|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1995|11/29/1995|||APPR|APPROVAL FOR USE OF AN ALTERNATE STERILIZATION PROCESS AND A MODIFICATION TO THE DISTAL END OF THE TRANSVENE LEADS
P840008|S052|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER TRANSPORTABLE (DLT)|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/1995|10/05/1995|||APRL|APPROVAL FOR A NEW MODEL LITHOTRIPTER, THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME DORNIER LITHOTRIPTER TRANSPORTABLE
P820003|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1995|03/13/1996|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS
P920015|S008|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC TRANSVENE LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1995|12/07/1995|||APPR|APPROVAL FOR USE OF AN ALTERNATE STERILIZATION PROCESS AND A MODIFICATION TO THE DISTAL END OF THE TRANSVENE LEADS
P890003|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC SYNERGYST II PULSE GENERATOR SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/1995|12/06/1995|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS
P870049|S024|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1995|03/12/1996|||APPR|APPROVAL FOR OFLOXACIN TO BE ADDED TOTHE GRAM-NEGATIVE RAPID FLUOROGENIC PANELS AT THE EQUIVALENCY CONCENTRATIONS OF 0.25 UG/ML TO 16 UG/ML
P890001|S014|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/1995|06/13/1996|||APPR|APPROVAL FOR REVISED LABELING
P900061|S019|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 9881E SOFTWARE (9881E 217214 REVISION:C)|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/14/1995|11/06/1995|||APPR|APPROVAL FOR MODEL 9881E SOFTWARE, 9881E 217214 REVISION:C, FOR MODEL 9790 AND 9790C PROGRAMMERS WITH MODEL 7216/7217 PCD AND 7201 CD DEVICES
P890047|S008|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|DUOVISC VISCOELASTIC SYSTEM|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/1995|03/22/1996|||APPR|APPROVAL FOR 1)ALTERNATE MANUFACTURING SITE (PUURS, BELGIUM; 2)USE OF 100% ETHYLENE OXIDE IN THE STERILIZATION PROCESS; 3)INCLUSION OF THE DELIVERY CANNULA WITH THE SYRINGE ASSEMBLY INSIDE THE PLASTIC TRAY; AND 4)CHANGE IN THE BLISTER TRAY MATERIAL FROM POLYVINYL CHLORIDE TO POLYETHYLENE TEREPHTHALATE GLYCOL
P810002|S038|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MECHANICAL HEART VALVE SJM(R) MASTER SERIES|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/1995|03/13/1996|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE (ALL CURRENTLY APPROVED MODELS) AND THE COATED AORTIC VALVED GRAFT (CAVG), MODEL CAVG-404
P900023|S016|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/1995|03/12/1996|||APPR|APPROVAL FOR A CHANGE  TO A COMPONENT IN THE BVS 5000 CONSOLE, THE HONEYWELL SOLENOID VALVE , AND TO EXTEND THE RECOMMENDED REPLACEMENT ITME
P890003|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/1995|10/31/1995|||APPR|APPROVAL TO MARKET SOFTWARE (MODEL 9889E) WHICH IS DESIGNED TO PROVIDE PROGRAMMING CAPABILITIES, USING THE ALREADY APPROVED 9790 AND 9790A PROGRAMMERS FOR THREE MODELS OF PULSE GENERATORS AS RELABELED FOR DISTRIBUTION BY ANOTHER COMPANY, CPI UNDER THEIR TRADE NAMES.  THE PACEMAKERS ARE: THE LEGEND TO BE RELABELED AS TRIUMPH VR, ELITE TO BE RELABELED AS PRELUDE DR AND SYNERGYST II TO BE RELABELED AS TRIUMPH DR.
P920014|S002|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE(R) 1000A IP LVAD|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/1995|11/17/1995|||APPR|APPROVAL FOR AN INTERIM DESIGN CHANGE OF THE PERCUTANEOUS VENT LEAD (PVL)
P840064|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT VISCOELASTIC SYSTEM|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/1995|03/22/1996|||APPR|APPROVAL FOR: 1)ALTERNATE MANUFACTURING SITE AT PUURS, BELGIUM; 2)USE OF 100% ETHYLENE OXIDE IN THE STERILIZATION PROCESS; AND 3)INCREASE IN THE ALLOWABLE FILL VOLUME TO 0.75 ML (THIS WAS INADVERTENTLY NOT INCLUDED IN OUR APPROVABLE LETTER OF 13-FEB-96)
P820036|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN DAILY CLEANER|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/1995|09/08/1995|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TO INCLUDE ELIMINATING AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS
N17945|S028|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/1995|09/08/1995|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TOINLCUDE ELIMINATING AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS
N17974|S048|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/1995|09/08/1995|||APPR|APPROVAL FOR CHANGES IN MANUFACTURING PROCESS TO INCLUDE ELIMINIATING AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS
P830034|S028|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/1995|09/08/1995|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TO ELIMINATE AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS
P830060|S040|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6888 LEAD TUNNELER ACCESSORY|LWS|CV|Normal 180 Day Track||N|02/10/1995|10/03/1995|||APPR|APPROVAL FOR CPI MODEL 6888 LEAD TUNNELER
P860019|S106|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED NC EXPRESS PLUS PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1995|10/31/1995|||APPR|APPROVAL FOR THE ADDITION OF XTRA SILICONE COATING TO THE POC BANDIT AND BANDIT PTCA CATHETER LINES
P910031|S004|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|CATHSCANNER ORACLE MICRO PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1995|01/18/1996|||APPR|APPROVAL FOR THE 25MM FACT CORONARY BALLOON DILATATION CATHETER
P820018|S068|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|REFLEX MODEL 8223E|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/15/1995|10/10/1995|||APPR|APPROVAL FOR THE ADDITION OF A POLYAMIDE INSULATOR TO THE TELEMETRY COIL
P910064|S012|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/14/1994|10/05/1995|||APPR|APPROVAL FOR CHANGES IN THE LABELING "KEY ELEMENTS".
P810046|S156|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1995|11/07/1995|||APPR|APPROVAL FOR AN ALTERNATIVE PACKAGING CONFIGURATION OFR THE FINAL PRODUCT PACKAGING FOR ACS CORONARY DILATATION CATHETERS
P900061|S020|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES.|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/1995|12/14/1995|||APPR|APPROVAL FOR MED REL, ROAD 909, KM.0.4, BARRIO MARIANA, HUMACAO, PUERTO RICO 00661 TO MANUFACTURE THE MODELS 7219B, 7219E, AND 7202E
P880072|S036|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J-LOOP POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/1995|02/12/1996|||APPR|APPROVAL FOR AN ALTERNATE CONTRACT STERILIZER, MEDICAL MANUFACTURING CORP., AT 2205 EAST 33RD STREET, ERIE, PA 16510, AND CONVERSION FROM 12/88 ETHYLENE OXIDE (ETO)/FREON TO 100% ETO STERILIZATION
P820036|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-CLEAN DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/1995|01/04/1996|||APPR|APPROVAL TO USE 100% ETHYLENE OXIDE AS AN ALTERNATE STERILIZATION METHOD OF PRIMARY PACKAGING COMPONENTS  -  THE ALTERNATE STERILIZATION METHOD WILL BE PERFORMED AT ISOMEDIX, 2072 SOUTHPORT RD., SPARTANBURG, SC
N17974|S049|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PREFLEX DAILY CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/1995|01/04/1996|||APPR|APPROVAL TO USE 100% ETHYLENE OXIDE AS AN ALTERNATE STERILIZATION METHOD OF PRIMARY PACKAGING COMPONENTS - THE ALTERNATE STERILIZATION METHOD WILL BE PERFORMED AT ISOMEDIX, 2072 SOUTHPORT RD., SPARTANBURG, SC
N17945|S029|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|ADAPETTES LUBRICATING AND REWETTING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/1995|01/04/1996|||APPR|APPROVAL TO USE 100% ETHYLENE OXIDE AS AN ALTERNATE STERILIZATION METHOD OF PRIMARY PACKAGING COMPONENTS - THE ALTERNATE STERILIZATION METHOD WILL BE PERFORMED AS ISOMEDIX, 2072 SOUTHPORT RD., SPARTANBURG, SC
P910020|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY/DASH/STRIDE/DART PACING SYSTEMS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/1995|03/15/1996|||APPR|ALTERNATE ACCELEROMETER
P930029|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR(TM) RFCA SYSTEM|LPB|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|08/30/1995|09/30/1996|||APPR|APPROVAL FOR THE ADDTION OF A GRAPH SHOWING THE RELATIONSHIP OF INITIAL ATAKR POWER OUTPUT TO TEMPERATURE SET POINT DURING THE RAMP UP PERIOD IN TEMPERATURE CONTROL MODE AND THE ADDTION OF A WARNING STATEMENT REARDING PROPER CONNECTION TECHNIQURES WHEN UTILIZING THE ATAKR SYSTEM WITH OTHER CATHETER LABORATORY EQUIPMENT
P870076|S001|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM|KNH|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/1995|01/02/1996|||APPR|APPROVAL FOR A CHANGE OF STERILIZATION FACILITY TO THE GRIFFITH MICROSCIENCE FACILITY IN WILLOWBROOK, ILLINOIS, FOR THE PRODUCTS INCLUDING THE DISPOSABLE FALOPE-RING APPLICATOR KIT WITH 8MM TROCAN DISPOSABLE TROCAR AND CANNULA, (REORDER NUMBER 005280-901), AND DISPOSABLE FALOPE-RING APPLICATOR KIT WITHOUT 8MM TROCAN DISPOSABLE TROCAR AND CANNULA, (REORDER NUMBER 006889-901)
P910073|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1995|04/02/1996|||APPR|APPROVAL FOR LEAD ADAPTER MODELS 6024, 6833, 6931
N12159|S015|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL* FIBRILLAR ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|09/01/1995|02/01/1996|||APPR|APPROVAL FOR A MANUFACTURING CHANGE WHICH ADDS A STEP TO FORM A FIBRILLAR STRUCTURE FOR THE DEVICE. AS MODIFIED THE DEVICE WILL MARKETED UNDER THE TRADE NAME SURGICEL
P840040|S049|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER|LOX|CV|THIRTY DAY TRACK|Labeling Change - Indications/instructions/shelf life/tradename|N|09/05/1995|10/19/1995|||APPR|APPROVAL FOR REVISED LABELING TO ADDRESS OUR PTCA LABELING LETTER OF JANUARY 7, 1995, AND CHANGE THE CORPORATE NAME ON YOUR LABELING FROM MANSFIELD/BOSTON SCIENTIFIC CORPORATION TO SCIMED/BOSTON SCIENTIFIC CORPORATION
P870018|S011|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR SHOCK WAVE SYSTEM C|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/1995|03/01/1996|||APRL|APPROVAL FOR MODIFICATIONS MADE TO THE SHOCK TUBE, WATER CONDITIONING SYSTEM, SHOCK WAVE GENERATOR, SHOCK WAVE ENERGY SETTING, AND LABELING. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR SHOCK WAVE SYSTEM C
P880047|S004|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED TC7  ABSORBABLE ADHESION BARRIER|MCN|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/05/1995|02/08/1996|||APPR|APPROVAL FOR LABELING CHANGES FOR INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
P910020|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY/DASH/STRIDE/DART PACING SYSTEMS|DXY|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/1995|03/22/1996|||APPR|APPROVAL FOR THE CHANGE IN STERILANT FROM AMIXTURE OF 12% ETHYLENE OXIDE AND 88% FREON TO A MIXTURE OF 8.5% ETHYLENE OXIDE AND 91.5% CARBON DIOXIDE
P840040|S050|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/06/1995|10/19/1995|||APPR|APPROVAL FOR REVISED LABELING TO ADDRESS OUR PTCA LABELING LETTER OF JAN 7, 1995 AND CHANGE THE CORPORATE NAME ON YOUR LABELING FROM MANSFIELD/BOSTON SCIENTIFIC CORP TO SCIMED/BOSTON SCIENTIFIC CORP
P910031|S005|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|ORACLE(TM) CORONARY BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/07/1995|03/13/1996|||APPR|APPROVAL FOR THE ARC CORONARY BALLOON DILATATION CATHETER
P810002|S039|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF)|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1995|03/21/1996|||APPR|APPROVAL FOR AN EXPANDED VERSION OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE WITH TEFLON SEWING CUFF. THE NEW MODELS WILL BE AVAILABLE IN THE AORTIC SIZES OF 19, 21, 23, 25, 27, 29, AND 31 MM (AET-104) AND THE MITRAL SIZES OF 19, 21, 23, 25, 27, 29, 31, AND 33MM (MET-104)
P810002|S040|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1995|05/01/1996|||APPR|APPROVAL FOR AN INCREASE OF THE LEAFLET LOT SIZES DURING THE PYROLYTIC CARBON COATING PROCESS AT THE WOODBRIDGE PYROLYTIC CARBON COATING FACILITY
P780002|S012|SYNOVIS SURGICAL INNOVATIONS|2575 UNIVERSITY AVE. WEST||ST. PAUL|MN|55114|1024|TISSUE GRAFT OF 6MM AND GREATER|DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT|LXA|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/1995|11/24/1995|||APPR|
P910020|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/1995|07/31/1996|||APPR|APPROVAL FOR THE UNITY MODEL 292-07 SINGLE PASS (VDDR) PULSE GENERATOR WITH UNIPASS LEADS MODELS 425-02, 425-04 AND 425-06 AND MODEL 531-60 GRAPHICS PROGRAM MODULE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UNITY
P840068|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR MODEL 2880 SOFTWARE APPLICATION|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/1995|03/22/1996|||APPR|APPROVAL FOR THE USE OF THE VIGOR MODEL 2880 SOFTWARE APPLICATION USED IN CONJUNCTION WITH THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) ON THE MODEL 2950 PRM FOR PROGRAMMING OF ALL COMMERCIALLY AVAILABLE VIGOR PACEMAKERS
P940031|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR(TM) DR PACEMAKER SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/1995|03/21/1996|||APPR|APPROVAL FOR THE USE OF THE VIGOR MODEL 2880 SOFTWARE APPLICATION USED IN CONJUNCTION WITH THE MODEL 2909 MULTIPLE APPLICATIO UTILITY (MAU) ON THE MODEL 2950 PRM FOR PROGRAMMING OF ALL COMMERCIALLY AVAILABLE VIGRO PACEMAKERS
P920030|S001|BAYER HEALTHCARE, LLC|511 BENEDICT AVE.||TARRYTOWN|NY|10591||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|CIBA CORNING ACS PSA IMMUNOASSAY|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/1995|12/13/1995|||APPR|APPROVAL FOR A CHANGE IN THE METHOD OF STANDARDIZATION OF THE CALIBRATORS FOR THE ASSAY
P810046|S157|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/14/1995|12/05/1995|||APPR|APPROVAL FOR THE ACS OTW LIFESTREAM CORONARY DILATATION CATHETER
P860019|S107|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED LEAP EXPRESS PLUS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/1995|10/31/1995|||APPR|APPROVAL FOR THE ADDITION OF QUARTER SIZED BALLOON DIAMETERS AND THE USE OF AN ALTERNATE ORANGE COLORANT IN THE BALLOON MANIFOLDS FOR THE LEAP EXPRESS PLUS PTCA CATHETER LINE
P830026|S064|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS FAMILY OF PULSE GENERATORS|LWP|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1995|04/01/1996|||APPR|ALTERNATE STERILIZATION PROCESS
P940008|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS|LWS|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1995|03/21/1996|||APPR|ALTERNATE STERILIZATION PROCESS
P860007|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R) FAMILY OF PULSE GENERATORS|LWW|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1995|05/21/1996|||APPR|ALTERNATE STERILIZATION PROCESS
P920051|S002|KARL STORZ ENDOSCOPY-AMERICA, INC.|1201 ROBERTS BLVD.||KENNESAW|GA|30144|||STORZ MODULITH (TM) LITHOTRIPTER||GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/1995|12/11/1995|||APRL|APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1)INCLUSION OF AN UPGRADED VIDEO MIXER; 2) MODIFICATION OF THE WATER CIRCUIT TO INCLUDE PRESSURE FEEDBACK; 3) REPLACEMENT OF THE NYLON/ALUMINUM PATIENT TABLE WITH A CARBON FIBER MODEL; 4) ADDITION OF THE FVP-30 X-RAY IMAGE PROCESSING FEATURE (WHICH ALSO INCLUDED REVISIONS OT THE X-RAY OPERATOR'S AND SERVICE MANUALS)
P840060|S025|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/31/1995|10/05/1995|||APPR|APPROVAL FOR MODEL MC50CD ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
N18466|S019|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS|LOD|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/20/1995|11/20/1995|||APPR|APPROVAL FOR CMW 1 RADIOPAQUE, CMW2 AND CMW3 TO BE MARKETED UNDER WRIGHT MEDICAL AS:ORTHOSET 1, ORTHOSET 2, AND ORTHOSET 3 BONE CEMENT, RESPECTIVELY.
P840019|S012|HYBRITECH, INC.|11095 TORREYANA RD.|P.O. BOX 269006|SAN DIEGO|CA|92126||SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN|TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY|DHX|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/1995|03/07/1996|||APPR|MODIFICATIONS TO THE HYBRITECH TANDEM-E CEA ASSAY WHITH ENHANCEMENTS IN THE FORMUALTION OF THE ALKALINE PHOSPHATASE-LABELED ANTI-CEA ANTIBODY CONJUGATE AND THE ADDTION OF THE BLOCKING REAGENT POLY MAK 33, A COPOLYMER OF INTACT AND FAB FRAGMENTED MOUSE ANTI-HUMAN CK-MM ANTIBODIES
P790017|S057|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI XPRT WITH PRO/PEL COATING BALLOON DILATATION|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/20/1995|01/25/1996|||APPR|APPROVAL FOR REVISED LABELING
P810046|S158|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CONCORFE(TM) CORONARY DILATION BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/1995|02/05/1996|||APPR|APPROVAL FOR ACS CONCORDE CORONARY DILATATION CATHETER
P930029|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RFCA SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/1995|06/11/1996|||APPR|APPROVAL FOR THE ADDITION OF THE RF PERFORMER SERIES OF CARDIAC ABLATION CATHETERS FOR THE ATAKR RFCA SYSTEM
P840064|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DUOVISC VISCOELASTIC SYSTEM|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1995|03/26/1996|||APPR|APPROVAL FOR MANUFACTURE OF DUOVISC AT ALCON-COUVREUR, PUURS, BELGIUM AND A SINGLE BLISTER PACKAGE WHICH WILL CONTAIN BOTH PROVISC AND VISCOAT WITH THEIR DELIVERY CANNULAS (24 MONTHS EXPIRATION)
P890047|S009|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|DUOVISC VISCOELASTIC SYSTEM|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1995|03/26/1996|||APPR|APPROVAL FOR MANUFACTURE OF DUOVISC AT ALCON-COUVREUR, PUURS, BELGIUM AND A SINGLE BLISTER PACKAGE WHICH WILL CONTAIN BOTH PROVISC AND VISCOAT WITH THEIR DELIVERY CANNULAS (24 MONTHS EXPIRATION)
P930014|S002|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/1995|03/26/1996|||APPR|ALTERNATE STERILIZATION PROCESS INCLUDING AERATION AND TH4E ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME AT YOUR HUNTINGTON, WEST VIRGINIA SITE
P870049|S025|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS|LON|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/1995|05/03/1996|||APPR|APPROVAL FOR EXPANDED GENTAMICIN DILUTIONS AT CONCENTRATIONS OF 0.12-4, 6, AND 8UG/ML, THE REMOVAL OF THE LIMITATION FOR THE TESTING OF SALMONELLA/SHIGELLA WITH GENTAMICIN, AND ADDITIONAL LIMITATIONS FOR THE TESTING OF ACINETOBACTER BAUMANII AND STENOTROPHOMONAS MALTOPHILIA WITH GENTAMICIN
N18466|S020|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.|LOD|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/1995|11/20/1995|||APPR|APPROVAL FOR THE FOLLOWING:1)ADDITION OF A DISTRIBUTOR LABEL TO BE PLACED ON TO THE BOTTOM OF THE OUTER CARTON; AND 2) THE STERILE POWDER PACKAGE WILL BE PLACED INTO A NONSTERILE PROTECTIVE LAMINATED FOIL POUCH
P830037|S039|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FRESHLOOK COLORS UV AND FRESHLOOK LITETINT UV (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1995|01/25/1996|||APPR|APPROVAL FOR INCORPORATING AN ULTRA-VIOLET ABSORBER INTO THE DEVICE
P790017|S058|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI GRUNTZIG DILICA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI PROCROSS ELITE OVER THE WIRE W/PRO/PEL COATING|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1995|05/13/1996|||APPR|APPROVAL FOR THE USCI PROCROSS ELITE OVER THE WIRE BALLOON DILATATION CATHETER WTIH PRO/PEL COATING AND ANTI BACK BLEED DEVICE
P880091|S005|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIC LENS AND ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/1995|01/18/1996|||APPR|APPROVAL TO CHANGE THE MOLDING PARAMETERS
P910073|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) LEAD SYSTEM/MODEL 6952 LEAD EXTENDER|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1995|04/01/1996|||APPR|MODEL 6952 LEAD EXTENDER
P890023|S003|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1995|07/12/1996|||APPR|APPROVAL FOR TINTING, WET PROCESSING, PACKAGING, AND STERILIZATION OF THE ABOVE-REFERENCED LENSES AT THE COMPANY'S FACILITY LOCATED AT SANTA ISABEL INDUSTRIAL PARK (FORMALLY KNOWN AS FELICIA WARD INDUSTRIAL PARK); HIGHWAY 538, KM 0.7, PUERTO RICO 00757
P800041|S015|PACESETTER SYSTEMS|15900 VALLEYVIEW COURT|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|CARBON TIP CARDIAC PACING LEAD|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1995|01/04/1996|||APPR|APPROVAL FOR THE ADDITION OF A "NITROGEN BLANKET" TO STERILIZATION PROCESS
P830045|S050|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM|LWP|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1995|11/13/1995|||APPR|APPROVAL FOR THE INCORPORATION OF A "NITROGEN BLANKET" TO THE STERILIZATION PROCESS USED AT THE SYLMAR, CA, FACILITY OF PACESETTER, INC.
P880006|S023|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1995|11/13/1995|||APPR|APPROVAL FOR THE INCORPORATION OF A "NITROGEN BLANKET" TO THE STERILIZATION PROCESS USED AT THE SYLMAR, CA, FACILITY OF PACESETTER, INC.
P880086|S034|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM|DXY|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1995|11/13/1995|||APPR|APPROVAL FOR THE INCORPORATION OF A "NITROGEN BLANKET" TO THE STERILIZATION PROCESS USED AT THE SYLMAR, CA, FACILITY OF PACESETTER,  INC.
P870007|S010|OPTOPICS LABORATORIES CORP.|32 MAIN ST., P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|SORBIC ACID PRESERVED SALINE SOL.PH CHANGE|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/1995|04/22/1996|||APPR|APPROVAL FOR TRANSFER OF THE PROCESSING SITE FOR 100 PERCENT ETHYLENE OXIDE (ETO) STERILIZATION OF PLASTIC CONTAINERS, TIPS AND CLOSURES USED IN THE MANUFACTURE OF SORBIC ACID PRESERVED STERILE SALINE FOR SOFT CONTACT LENSES. THE ETO STERILIZATION FACILITY IS GRIFFITH MICROSCIENCE GLEN FALLS FACILITY, LOCATED IN GLEN FALLS, NY
P860003|S027|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHORESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/1995|05/17/1996|||APPR|APPROVAL TO CHANGE THE MANUFACTURING FACILITY FOR THE TPS102 PHOTOCEPTOR COMPONENT OF THE UVAR PHOTOPHERESIS SYSTEM FROM THERAKOS TO HARMAC MEDICAL PRODUCTS AT 2201 BAILEY AVENUE IN BUFFALO, NEW YORK (ESTABLISHMENT REGISTRATION #1317547)
P870076|S003|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM|KNH|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/1995|03/01/1996|||APPR|APPROVAL FOR A CHANGE OF STERILIZATION FACILITY TO THE MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA FOR THE PRODUCTS INCLUDING THE FALOPE-RING BAND:BOX OF 30 STERILE PROCEDURE KITS (REORDER NUJBER 000719-250), AND FALOPE-RING BAND: BOX OF 100 STERILE PROCEDURE KITS (REORDER NUMBER 001452-901)
N17755|S045|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|ZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT|LOD|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/1995|10/17/1996|||APPR|CHANGE IN ETHYLENE OXIDE STERILIZATIN PROCESS USED IN THE STERILIZATION OF THE EXTERNAL SURFACE OF THE BONE CEMENT'S MONOMER AMPULES
P910077|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) PRX (TM) II AICD SYSTEM|LWS|CV|Normal 180 Day Track||N|08/25/1995|02/05/1996|||APPR|APPROVAL FOR THE USE OF MODEL 2872 SOFTWARE APPLICATION, REV. 4.1 AND MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) WITH THE VENTAK PRX II/III PULSE GENERATOR AND MODEL 2950 PRM
P910077|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM|LWS|CV|Normal 180 Day Track||N|09/12/1995|04/29/1996|||APPR|APPROVAL FOR THE VENTAK MINI HC (MODELS 1742, 1743, AND 1640) WHICH IS AN ACTIVE CAN VERSION OF YOUR COMMERCIALLY AVAILABLE VENTAK MINI AICD SYSTEM AND THE VENTAK MINI II HC AICD SYSTEM (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH IS A DOWN-SIZED VERSION OF THE VENTAK MINI HC AICD SYSTEM. THE MINI II HC MAXIMUM ENERGY LEVELS ARE 25 AND 27 JEWELS WHERE THE MINI HC MAXIMUM ENERGY LEVEL IS 29 JEWELS
P930031|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT(R) TIPS ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1995|01/29/1996|||APPR|APPROVAL FOR THE ADDITION OF 10 MM DIAMETER BY 94 MM LENGTH WALLSTENT TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) ENDOPROSTHESIS
P930012|S001|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|PAS LACROSSE TM PTCA CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/1995|04/02/1996|||APPR|APPROVAL FOR THE USE OF 100% ETHYLENE OXIDE STERILIZATION TO BE PERFORMED AT MEDICAL MANUFACTURING CORPORATION, ERIE, PA
P930012|S002|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|EXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1995|04/16/1996|||APPR|ADDITION OF 1.5MM DIAMETER, 20 MM LENGTH BALLOON; ADDITION OF 2.5MM, 3.0MM, AND 4.0MM BALLOONS, ALL WITH 30MM LENGTH; CHANGE IN RATED BURST OF THE 2.0MM AND 2.5MM BALLOONS WITH 20MM LENGTH
P840039|S048|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|EZE-FIT(TM)|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/10/1995|07/18/1996|||APPR|APPROVAL FOR THE TRADE NAME EZE-FIT FOR YOUR ONE-PIECE POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
P800022|S048|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM I AND II AND ZYPLAST COLLAGEN IMPLANTS|LMH|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/1995|02/01/1996|||APPR|APPROVAL FOR A MANUFACTURING CHANGE
P900030|S004|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN BARD COLLAGEN IMPLANT|LNM|GU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/1995|02/01/1996|||APPR|APPROVAL FOR A MANUFACTURING CHANGE
P900039|S009|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT BONE GRAFT MATRIX|MBS|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/1995|02/01/1996|||APPR|APPROVAL FOR A MANUFACTURING CHANGE
P870036|S036|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR|LOX|CV|Normal 180 Day Track||N|07/17/1995|04/08/1996|||APPR|REVISED LABELING
N17755|S046|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|OSTEOBOND(TM) COPOLYMER BONE CEMENT|LOD|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/1995|11/20/1995|||APPR|APPROVAL FOR THE ADDITION TO THE LABELING OF THE FOLLOWING WARNING STATEMENT: "DO NOT CENTRIGUGE OSTEOBOND COPOLYMER BONE CEMENT. ALTHOUGH CENTRIFUGATION HAS BEEN SHOWN IN SOME CASES TO IMPROVE THE PHYSICAL STRENGTH OF THE CURED CEMENT BY REMOVAL OF ENTRAPPED AIR AND OTHER GASES, A UNIFORM DISPERSION OF THE RADIOPACIFIER CANNOT BE ASSURED. THEREFORE, THE USE OF CENTRIGUGATION IS NOT ADVISABLE."
P900023|S017|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/1995|11/30/1995|||APPR|APPROVAL FOR THE ADDITION OF REFERENCE CARDS TO BE PLACED IN A HOLDER ATTACHED TO THE CONSOLE
P840002|S007|CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|TAPSYSTEM 2A|LPA|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1995|10/03/1997|||APPR|Approval for a manufacturing site lcoated at Haller Industries, Inc. 4895 West Waters, Suite J, Tampa Florida.
P880072|S037|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODIFIED J & C LOOP MODEL PA36 POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1995|11/01/1995|||APPR|APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENS MODEL PA84B-OUV
P880031|S009|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|AMO(R) VITRAX(R) VISCOELASTIC SOLUTION|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/1995|04/09/1996|||APPR|NEW STERILIZATION SITE AT GRIFFITH MICRO SCIENCE IN GLEN FALLS, NEW YORK AND A NEW STERILIZATION PROCESS, 100% ETHYLENE OXIDE, FOR AMO VITRAX (SODIUM HYALURONATE) IN FINAL PACKAGING
P930027|S001|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|IMMULITE(R) THIRD GENERATION PSA|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/1995|07/11/1996|||APPR|APPROVAL FOR CHANGING THE COAT-A-COUNT PSA IRMA FROM AN IMMUNORADIOMETRIC TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM TO A SOLID PHASE, TWO-SITE CHEMILUMINESCENT IMMUNOMETRIC ASSAY FOR USE ON THE IMMULITE AUTMOATED IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE PSA
P810046|S159|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/1995|02/26/1996|||APPR|APPROVAL FOR THE ACS ENDURA CORONARY DILATATION CATHETER
P890023|S004|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES|LPM|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1995|08/28/1996|||APPR|APPROVAL FOR THE FOLLOWING: 1)MODIFYING THE MANUFACTURING PROCESS FOR THE OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR LENSES FROM A LOCATOR TINT DIPPING PROCESS AT THE END OF THE MANUFACTURING PROCEDURE TO THE ADDITION OF AN IN-MONOMER TINT INCORPORATING VAT BLUE 6 DYE DURING THE POLYMERIZATION PHASE OF THE MANUFACTURING PROCESS; 2)USING BLISTER PACKAGINAS ALTERNATE PACKAGING MATERIAL; AND 3)ADDING THE FOLLOWING ALTERNATE MANUFACTUIRING SITE FOR LENSES MANUFACTURED BY THE PROCESS DESCRIBED IN ITEM 1: OCULAR SCIENCES/AMERICAN HYDRON, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE S053 4 ND, ENGLAND
P800022|S049|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYPLAST COLLAGEN IMPLANT ZYDERM I AND II COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/1995|11/30/1995|||APPR|APPROVAL FOR THE USE OF A RANGE OF FILL VOLUMES FOR THE ABOVE REFERENCED PRODUCTS FROM 0.1ML (TEST DOSE) TO 3ML
P860026|S005|AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR|GZE|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/1995|07/09/1996|||APPR|APPROVAL FOR A CHANGE IN MANUFACTURING FACILITY TO AVERY LABORATORIES INC., COMMACK, NEW YORK
P850048|S012|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/1995|05/03/1996|||APPR|CHANGE IN HYBRITECH'S IMMUNOENZYMETRIC PSA ASSAY FROM A BEAD FORMAT TO A MICROPLATE (MP) FORMAT (TANDEM-MP PSA ASSAY)
P940007|S001|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL/FOLDABLE IOL MODEL 127(920)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/30/1995|05/20/1996|||APPR|APPROVAL FOR TIER B POSTERIOR CHAMBER INTRAOCULAR LENS MDOEL 127 AS A PARENT LENS AND THE BLUE CORE POLYMETHYLMETHACRYLATE HAPTIC MATERIAL. THE DEVICE, LENS MODEL 127, WILL BE MARKETED UNDER THE TRADE NAME MDOEL 920
P860057|S003|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS(R) PERICARDIAL BIOPROSTHESIS, MODEL 2700|DYE|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1995|12/06/1996|||APPR|ADDITIONAL MANUFACTURING FACILITY LOCATED AT BAXTER HEALTHCARE CORPORATION, EDWARDS CVS DIVISION, 1435 MCGAW AVE., IRVINE, CA  92714
P870077|S002|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)|DYE|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1995|12/06/1996|||APPR|ADDITIONAL MANUFACTURING FACILITY LOCATED AT BAXTER HEALTHCARE CORPORATION, EDWARDS CVS DIVISION, 1435 MCGAW AVE., IRVINE, CA  92714
P870056|S002|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS LOW PRESSURE BIOPROSTHESIS MODELS 2625 (AORTIC) AD 6625 (MITRAL)|DYE|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1995|12/06/1996|N||APPR|ADDITIONAL MANUFACTURING FACILITY LOCATED AT BAXTER HEALTHCARE CORPORATION, EDWARDS CVS DIVISION, 1435 MCGAW AVENUE, IRVINE, CALIFORNIA, 92714.
P790027|S059|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1995|05/01/1996|||APPR|APPROVAL OF THE FOLLOWING: IMPLEMENTATION OF NEW MANUFACTURING PROCESSES OF CLEAR AND VIOLET HAPTIC POLYMETHYLMETHACRYLATE (PMMA) ONE-PIECE POSTERIOR CHAMBER LENSES; THE USE OF A NEW TUMBLING PROCESS FOR YOUR THREE-PIECE LENSES; AND THE INTRODUCTION OF SEVERAL TIER A POSTERIOR CHAMBER LENSES, MODELS 8192B, 8490B, 8492B, 8090B, 8091B, 8193B, 8491B, 8493B, 8990B, 8991B, 8093B, 8095B, 8195B, AND 8594B.
P870013|S008|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1995|05/01/1996|||APPR|APPROVAL OF THE FOLLOWING: IMPLEMENTATION OF NEW MANUFACTURING PROCESSES OF CLEAR AND VIOLET HAPTIC POLYMETHYLMETHACRYLATE (PMMA) ONE-PIECE POSTERIOR CHAMBER LENSES; THE USE OF A NEW TUMBLING PROCESS FOR YOUR THREE-PIECE LENSES; AND THE INTRODUCTION OF SEVERAL TIER A POSTERIOR CHAMBER LENSES, MODELS 8192, 8490B, 8492B, 8090B, 8091B, 8193B, 8491B, 8493B, 8990B, 8991B, 8093B, 8095B, 8195B, AND 8594B
P850059|S016|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/1995|05/01/1996|||APPR|APPROVAL OF THE FOLLOWING:IMPLEMENTATION OF NEW MANUFACTURING PROCESSES OF CLEAR AND VIOLET HAPTIC POLYMETHYLMETHACRYLATE (PMMA) ONE-PIECE POSTERIOR CHAMBER LENSES; THE USE OF A NEW TUMBLING PROCESS FOR YOUR THREE-PIECE LENSES; AND THE INTRODUCTION OF SEVERAL TIER A POSTERIOR CHAMBER LENSES, MODELS 8192B, 8490B, 8492B, 8090B, 8091B, 8193B, 8491B, 8493B, 8491B, 8493B, 8990B, 8991B, 8093B, 8095B, 8195B, AND 8594B
P870036|S037|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER 30 AND 40|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1995|12/07/1995|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE ADHESIVE ON HTE REFERENCED PTCA CATHETERS (VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM - MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER, PANTHER 30, AND PANTHER 40 PTCA CATHETERS)
P790018|S026|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/1995|12/07/1995|||APPR|APPROVAL FOR 100% ETO STERILIZATION
P930030|S001|COLETICA S.A.|32 RUE ST., JEAN DE DIEU||LYON||69007||Agent, absorbable hemostatic, collagen based|ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/02/1995|11/30/1995|||APPR|APPROVAL FOR A CHANGE IN TRADE NAME THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
P840024|S059|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/1995|12/11/1995|||APPR|APPROVAL TO MAKE CHANGES TO THE MINI 22 COCHLEAR IMPLANT INTEGRATED CIRCUIT (IC) TEST SOFTWARE (K15001) IN ORDER TO ADD SEVERAL TEST OF IMPROVED QUALITY ASSURANCE. ONE MODIFICATION YOU HAVE REQUESTED IS TO ADD A POWER SUPPLY LEAKAGE TEST TO AID IN ENSURING THAT THE BIPOLAR TANTALUM POWER SUPPLY CAPACITOR IS NOT ASSEMBLED IN THE REVERSE DIRECTION. THE SECOND MODIFICATION YOU HAVE REQUESTED IS TO IMPLEMENT AN AUTOMATIC EVALUATION OF THE DATA MEASURED FORMT HE INTEGRATED CIRCUTI PRIOR TO ITS FINAL ASEMBLY IN ORDER TO ELIMINATE OPERATOR ERROR
P890027|S028|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/1995|12/11/1995|||APPR|APPROVAL TO MAKE CHANGES TO THE MINI 22 COCHLEAR IMPLANT INTEGRATED CIRCUIT (IC) TEST SOFTWARE (K15001) IN ORDER TO ADD SEVERAL TEST OF IMPORVED QUALITY ASSURANCE. ONE MODIFICATION YOU HAVE REQUESTED IS TO ADD A POWER SUPPLY LEAKAGE TEST TO AID IN ENSURING THAT THE BIPOLAR TANTALUM POWER SUPPLY CAPACITOR IS NOT ASSEMBLED IN THE REVERSE DIRECTION. THE SECOND MODIFICATION YOU HAVE REQUESTED IS TO IMPLEMENT AN AUTOMATIC EVALUATION OF THEDATA MESURED FROM THE INTEGRATED CIRCUIT PRIOR TO ITS FINAL ASSEMBLY IN ORDER TO ELIMINATE OPERATOR ERROR
P860019|S108|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED WAVE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1995|06/10/1996|||APPR|APPROVAL FOR THE SCIMED WAVE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PERFUSION CATHETER. THE DEVICE AS MODIFIED WILL BE MARKETED FOR THE BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION
P900030|S005|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN BARD COLLAGEN IMPLANT|LNM|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/1995|03/08/1996|||APPR|APPROVAL FOR:1) MARKETINGTHE CURRENT CONTIGEN IMPLANT PRODUCT LINE IN A MODIFIED PACKAGING CONFIGURATION INSTEAD OF THE CURRENT CONFIGURATION, 2)CHANGING THE LOCATION OF THE SKINT TEST PACKAGING OPERATIN FROM COLLAGEN CORP, FREMONT, CA, TO BARD UROLOGICAL DIV, COVINGTON, GA 3)REVISING THE WARNING STATEMENT REGARDING CONNECTIVE TISSUE DISEASE IN THE PACKAGE INSERTS, PATIENT BROCHURES AND SAFETY SUMMARIES, AND 4)UPDATING THE PATIENT RECORD AND SKIN TEST CARD LABELING
P900061|S021|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODTRONIC(R) MODELS 7219/B/C/D/E AND 7202C/D/E|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1995|02/04/1997|||APPR|APPROVAL FOR ALTERNATE FIRMWARE/HARDWARE DESIGN FOR THE MEDTRONIC (R) MODELS 7219B/C/D/E AND 7202C/D/E
P910031|S006|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|CATHSCANNER ORACLE MICRO PTCA CATHETER FACT BALLOON CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/1995|01/30/1996|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE:13900 ALTON PARKWAY, SUITE 122, IRVINE, CALIFORNIA, 92718 FOR THE FACT BALLOON CORONARY DILATATION CATHETER
P930029|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1995|02/22/1996|||APPR|APPROVAL OF THE ABLATION TRACKR SOFTWAE FOR USE WITH THE ATAKR RF CATHETER ABLATION GENERATOR SYSTEM
P820049|S062|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC-58NBM & PC-58NBZ IOLS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1995|10/07/1997|||APPR|Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."
P890056|S003|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1995|10/07/1997|N||APPR|Approval to modify the current maximum level of ethylene oxide residual     from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."
P880081|S019|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1995|10/07/1997|||APPR|Approval to modify the current maximum level of ethylene oxide residual    from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."
P860034|S013|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1995|10/07/1997|||APPR|Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."
P850070|S008|AUTOMATIC LIQUID PACKAGING, INC.|2200 W. LAKE SHORE DR.||WOODSTOCK|IL|60098||Accessories, soft lens products|STERILE SALINE PRESERVED SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1995|07/10/1996|||APPR|APPROVAL FOR AN ALTERNATE CLOSURE DESIGN WHICH UTILIZES A PIERCING CAP AND "FLIP-TOP" ON 12 OZ. AND 16 OZ. PRESERVED SLINE SOLUTION CONTAINERS ONLY
P950009|S001|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM|MNM|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/06/1995|04/25/1996|||APPR|APPROVAL FOR CHANGES MADE TO THE MANUAL TO IMPROVE HOW THE REPORT FORMS WILL LOOK, FOR CLARITY.
P910023|S014|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1995|06/11/1996|||APPR|APPROVAL FOR THE VENTRITEX EXTERNAL STIMULATOR ADAPTER (VESA) AND THE VENTRITEX HIGH VOLTAGE Y-ADAPTER
P890023|S005|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/1995|05/06/1997|||APPR|APPROVAL FOR THE CAST MOLDING METHOD FOR THE MANUFACTURE OF THE OCUFILCON D 55% HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR AT THE COMPANY'S FACILITY LOCATED AT SANT ISABEL INDUSTRIAL PARK (FORMALLY KNOWN AS FELICIA WARD INDUSTRIAL PARK); HIGHWAY 538, KM 0.7, PUERTO RICO 00757.
P930012|S003|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|PROGRESSIVE ANGTIOPLASTY SYSTEMS (PAS) CHAMPION PTCA CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1995|05/22/1996|||APPR|APPROVAL FOR THE PAS CHAMPION PTCA CATHETERS
P890056|S004|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1995|03/11/1996|||APPR|APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSEE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND APCKAGED IN THE SINGLE-POUCH TYVEK PACKAGING CONFIGURATION CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZAITON SERVICES OF GEORGIA (SSG)
P880028|S006|Hospira, Inc.|275 NORTH FIELD DR.|DEPT. 389, BLDG. H2-2|LAKE FOREST|IL|60045||FLUID, HYSTEROSCOPY|DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM|LTA|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/1995|01/04/1996|||APPR|APPROVAL FOR ALTERNATE MANUFACTURING FACILITY WITH ROQUEETE AMERICA, INC. IN KEOKUK, IOWA, FOR DEXTROSE USP. HYDROUS BULK DRUG AS A COMPONENT OF DEXTROSE HM 32%
P820049|S063|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC-58NBM & PC-58NBZ IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1995|03/11/1996|||APPR|APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSEE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND PACKAGED IN THE SINGLE-POUCH TYVEK PACKAGING CONFIGURATION CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZATION SERVICES OF GEORGIA (SSG)
P880081|S020|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1995|03/11/1996|||APPR|APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSEE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND PACKAGED IN THE SINGLE-POUCH TYVEK PACKAGING CONFIGURATIN CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZATION SERVICES OF GEORGIA(SSG)
P860034|S014|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/1995|03/11/1996|||APPR|APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND PACKAGED IN THE SINGLE-POUCH TYVEK PACKAGIN CONFIGURATIO CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZATION SERVICES OF GEORGIA (SSG)
P880003|S052|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|TITAN AND TITAN XL PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1995|03/13/1996|||APPR|APPROVAL FOR: 1)TITAN AND TITAN XL PTCA DILATATION CATHETERS WITH 3.25MM AND 3.75MM DIAMETER BALLOONS AVAILABLE IN 9MM OR 18MM LENGTHS 2)A MODIFIED HUB BONDING PROCESS 3)A CHANGE IN THE DEVICE NAME FROM TITAN 18 PTCA DILATATION CATHEGTERS TO TITAN PTCA DILATATION CATHETERS 4)ONE SET OF INSTRUCTION FOR USE FOR ALL TITAN AND TITAN XL PTCA DILATATION CATHETERS
P810046|S160|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS|LOX|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/22/1995|12/28/1995|||APPR|APPROVAL FOR MODIFICATIONS OF THE INFLATION/DEFLATION NOTCH OF THE ABOVE CATHETERS AND CHANGES TO THE GUIDE WIRE EXIT NOTCH AND PROXIMAL ADATPION VISUAL INSPECTIN CRITERIA OF THE RX LIFESTREAM CATHETER
P820060|S009|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AXSYM AFP (LIST 7A48)|LOJ|IM|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/22/1995|12/26/1995|||APPR|APPROVAL FOR A MODIFICATION OF THE POTENCY TEST FOR THE ANTI-AFP: ALKALINE PHOSPHATASE CONJUGATE
P880031|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|AMO VITRAX (SODIUM HYALURONATE)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1995|04/08/1996|||APPR|USE OF "PHARMACEUTICAL GRADE" SODIUM HYALURONATE POWDER SUPPLIED BY AKZO NOBEL CORPORATION, DIOSYNTH BV, KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLANDS, AS AN ALTERNATE SUPPLY OF SODIUM HYALURONATE POWDER FOR USE IN THE MANUFACTURE OF AMO VITRAX SODIUM HYALURONATE
P840024|S060|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1995|03/26/1996|||APPR|APPROVAL TO MAKE THE FOLLOWING CHANGES TO THE SPECTRA 22 SPEECH PROCESSOR:1)THE PRINTED CIRCUIT BOARD WILL BE REDESIGNED FROM A MULTI-LAYER BOARD CONFIGURATION TO A SINGLE-LAYER BOARD CONFIGURATION. 2)AN AUDIO MIXING FUNCTION, CALLED THE AUTOSWITCHING AUDIO CIRCUIT, WILL BE INCLUDED. 3) THE CLOCK OSCILLATOR FREQUENCY WILL BE CHANGED FROM A NOMINAL 5 MHZ TO 5.011 MHZ. 4)COMPONENTS WILL BE ADDED TO GIVE FURTHER PROTECTION FROM ELECTROSTATIC DISCHARGE (ESD). 5)THE EAR-LEVEL MICROPHONE POWER SUPPLY WILL BE CHANGED TO A COSTANT CURRENT SOURCE. 6)THE EXTERNAL INPUT SOCKET WILL BE REPLACED WITH AMORE ROBUST TYPE. 7)THE PATIENT SWITCH POSITIONS WILL BE CHANGED TO PUT THE "NORMAL" SENSITIVITY SELECTION FIRST. 8)A LONGER-LIFE BATTERY WILL BE PROVIDED. 9)A RESISTOR WILL BE INSERTED IN SERIES TO PROTECT THE BACK-UP BATTERY FROM EXCESSIVE CURRENT. 10)THERE WILL BE A VERSION OF THE SPECTRA 22 SPEECH PROCESSOR WHICH PROVIDES INCREASED TRANSMITTER POWER. 11)SOME MANUFACTURING TEST PARAMETERS WILL BE SLIGHTLY MODIFIED. 12)FOUR TESTS WILL BE ADDED DURING THE MANUFACTURING PROCESS. 13)THE USER INSTRUCTION MANUAL WILL BE REVISED
P890027|S029|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1995|03/26/1996|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE SPECTRA 22 SPEECH PROCESSOR: 1)THE PRINTED CIRCUIT BOARD WILL BE REDESIGNED FROM A MULTI-LAYER BOARD CONFIGURATION TO A SINGLE-LAYER BOARD CONFIGURATION. 2)AN AUDIO MIXING FUNCTION, CALLED THE AUTOSWITCHING AUDIO CIRCUIT, WILL BE INCLUDED. 3)THE CLOCK OSCILLATOR FREQUENCY WILL BE CHANGED FROM A NOMINAL 5 MHZ TO 5.011 MHZ. 4) COMPONENTS WILL BE ADDED TO GIVE FURTHER PROTECTION FROM ELECTROSTATIC DISCHARGE (ESD). 5)THE EAR-LEVEL MICROPHONE POWER SUPPLY WILL BE CHANGED TO A CONSTANT CURRENT SOURCE. 6)THE EXTERNAL INPUT SOCKET WILL BE REPLACED WITH AMORE ROBUST TYPE. 7)THE PATIENT SWITCH POSITIONS WILL BE CHANGED TO PUT THE "NORMAL" SENSITIVITY SELECTION FIRST. 8)A LONGER-LIFE BATTERY WILL BE PROVIDED. 9)A RESISTOR WILL BE INSERTED IN SERIES TO PROTECT THE BACK-UP BATTERY FROM EXCESSIVE CURRENT. 10)THERE WILL BE A VERSION OF THE SPECTRA 22 SPEECH PROCESSOR WHICH PROVIDES INCREASED TRANSMITTER POWER. 11)SOME MANUFACTURING TEST PARAMETERS WILL BE SLIGHTLY MODIFIED. 12)FOUR TESTS WILL BE ADDED DURIG THE MANUFACTURING PROCESS. 13) THE USER INSTRUCITON MANUAL WILL BE REVISED
P920032|S002|PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE|MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER|JOQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/27/1995|04/26/1996|||APPR|APPROVAL FOR THE PACESETTER, INC., MODEL 3070B PRIVATE LABEL VERSION OF THE PACE MEDICAL MODEL 4575
P910058|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|MODEL C11UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/1995|12/14/1995|n||APPR|APPROVAL FOR MODEL C11UB ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
P830055|S046|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/1995|07/17/1996|||APPR|ADDITIONAL OF THE POROUS-COATED METAL-BACKED, TEXTURED METAL-BACKED, AND ALL-POLYETHYLENE THREE-PEGGED PATELLA COMPONENT OPTIONS TO THE NEW JERSEY LCS TOTAL KNEE SYSTEM
P870025|S004|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR|MCP|OB|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/1995|02/01/1996|||APPR|APPROVAL FOR CHANGES IN THE QUALITY CONTROL AND MANUFACUTRING PRACTICES FOR THE TRANSDUCER IN COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR
P890001|S015|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR PICO RUNNER(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/1995|06/07/1996|||APPR|APPROVAL FOR AN EXTENSION OF THE LEOCOR PICO RUNNER PTCA CATHETER LINE TO INCLUDE A 4.0MM BALLOON DIAMETER
P920014|S003|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE(R) 1000A IP LVAD|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1995|04/12/1996|||APPR|APPROVAL FOR CHANGE IN THE DESIGN OF THE NON-BLOOD CONTACTING TITANIUM COMPONENTS USED IN THE INFLOW AND OUTFLOW VALVE CONDUITS AND IN THE OUTFLOW GRAFT CONDUIT
P830071|S006|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1995|06/04/1996|||APPR|APPROVAL FOR AN ALTERNATE FORMULATION. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392
P840008|S053|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER MOBILE|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1995|04/11/1996|||APRL|APPROVAL FOR A NEW MODEL LITHOTRIPTER. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME:DORNIER LITHOTRIPTER MOBILE
P910058|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHIROFLEX(TM)MODEL C10UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/1995|01/02/1996|||APPR|APPROVAL FOR ALLERGAN MEDICAL OPTICS TO DISTRIBUTE YOUR CHIROFLEX MODEL C1OUB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS AS THE AMO SINGLFLEX MODEL SI-14PB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER IOL
P880072|S039|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1995|04/08/1996|||APPR|APPROVAL FOR MODEL PA48A-OUV AS A TIER A MODIFICATION OF A PREVIOUSLY APPROVED MEDICAL DEVELOPMENTAL RESEARCH, INC. PARENT IOL. MODEL PA48A-OUV
P880072|S040|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/1995|04/17/1996|||APPR|APPROVAL FOR MODELS GL65C-OUV AND PS50D-OUV AS TIER A MODIFICATIONS OF PREVIOUSLY APPROVED MEDICAL DEVELOPMENTAL REASEARCH, INC. PARENT IOLS
P880003|S053|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1995|04/12/1996|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE TRAKSTAR 14 PTCA DILATATION CATHETER. AS MODIFIED THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME CORDIS THOR PTCA DILATATION CATHETER
P880091|S006|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/1995|07/01/1996|||APPR|APPROVAL TO ADD AN ALTERNATE VENDOR FOR PART OF YOUR MANUFACTURING PROCESS
P820018|S069|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|NETWORK PROGRAMMER MODEL 9602|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/1995|06/25/1996|||APPR|APPROVAL FOR THE NETWORK PROGRAMMER MODEL 9602 WITH APPLICATION SOFTWARE VERSION R5.3
P880038|S031|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|NETWORK PROGRAMMER MODEL 9602|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/1995|06/25/1996|||APPR|APPROVAL FOR THE NETWORK PROGRAMMER MODEL 9602 WITH APPLICATION SOFTWARE VERSION R5.3
P900070|S012|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|NETWORK PROGRAMMER MODEL 9602|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/1995|06/25/1996|||APPR|APPROVAL FOR THE NETWORK PROGRAMMER MODEL 9602 WITH APPLICATION SOFTWARE VERSION R5.3.
P850035|S018|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/08/1995|01/16/1996|||APPR|APPROVAL FOR REVISIONS TO THE PATIENT BROCHURE TITLED "ANSWERS TO YOUR QUESTIONS ABOUTTHE SPF SPINAL FUSION STIMULATOR." THESE CHANGES INCLUDE DELETION OF SPECIFIC, UNSUBSTNATIATED CLAIMS REGARDING PATIENTS SAFETY AND INCLUSION OF INFORMATION REGARDING DEVICE EXPLANATATION AND MRI WARNING AND PRECAUTION STATEMENTS, AS REQUESTED IN OUR JULY 18, 1995, LETTER
P880003|S054|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/1995|06/13/1996|||APPR|APPROVAL FOR ALTERNATE STERILIZATION SITE (ISOMEDIX) IN NORTHBOROUGH, MASSACHUSETTS
P880003|S055|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETER AND CORDIS VALOR AND VALOR XL PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/1995|04/23/1996|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE TRAKSTAR 14 PTCA DILATATION CATHETER - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME CORDIS VALOR AND VALOR XL PTCA DILATATION CATHETER
P910020|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/1995|05/03/1996|||APPR|APPROVAL FOR THE MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66 GRAPHICS PROGRAM MODULE. THE MARATHON FAMILY OF PULSE GENERATORS CONSISTS OF THE FOLLOWING MODELS: - MARATHON DR MODELS 294-09, 293-09, 294-09R, 294-10; MARATHON SR MODELS 292-09, 291-09, 292-09R, 292-10, 292-09X; COSMOS 3 MODELS 283-09, 284-09, 284-09R
P830026|S065|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX5000 PROGRAMMER MODEL 522-12|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1995|05/30/1996|||APPR|APPROVAL FOR ALTERNATE COMPPONENTS FOR THE RX5000 PROGRAMMER
P900009|S002|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A|LPQ|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/1995|04/02/1996|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY WHICH IS OWNED AND OPERATED BY HI-TRONICS DESIGNS, INC. AND LOCATED AT 999 WILLOW GROVE ST., BUILDING 2, SUITES 4A, 4B AND 18E, HACKETTSTOWN, NJ  07840. THE SAFHS MODEL 2A WILL BE MANUFACTURED AT THIS SITE
P840051|S007|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE|GAM|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/1995|01/11/1996|||APPR|APPROVAL FOR A REVISION OF THE EXISTING PACKAGE INSERTS, UNDER THE PROVISIONS OF 814.39(D)(1), SPECIAL PMA SUPPLEMENT-CHANGES BEING EFFECTED
P840041|S006|DAVIS & GECK, INC.|ONE CASPER ST.||DANBURY|CT|06810||Suture, nonabsorbable, synthetic, polyester|NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE|GAS|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/1995|01/11/1996|||APPR|APPROVAL FOR A REVISION OF THE EXISTING PACKAGE INSERTS, UNDER THE PROVISIONS OF 814.39(D)(1), SPECIAL PMA SUPPLEMENT-CHANGES BEING EFFECTED
P840039|S049|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|ONE PIECE POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/1995|06/05/1996|||APPR|APPROVAL TO EXTEND THE POWER RANGE FOR YOUR ONE-PIECE POSTERIOR CHAMBER IOLS FORM (+4.0 D) - (+34 D) TO (-18.0 D) - (+45 D).
P860002|S017|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/1995|06/05/1996|||APPR|APPROVAL TO EXTEND THE POWER RANGE FOR YOUR ONE-PIECE POSTERIOR CHAMBER IOLS FROM (+4.0 D) - (+34 D) TO (-18.0 D) - (+45 D)
P880090|S017|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/1995|06/05/1996|||APPR|APPROVAL TO EXTEND THE POWER RANGE FOR YOUR ONE-PIECE ANTERIOR CHAMBER IOLS FROM (+4.0 D) - (+34 D) TO (-4.5 D) - (+45D)
P860019|S109|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED WAVE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/1995|02/05/1996|||APPR|APPROVAL FOR THE USE OF AN EPOXY ADHESIVE IN THE MANIFOLD OF THE BANDIT, POC BANDIT, AND THE 15 MM NC BANDIT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETERS
P830060|S041|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1995|09/20/1996|||APPR|APPROVAL FOR MODELS 0012/0013 BIPOLAR ENDOCARDIAL LEADS; AND 0014/0015 POSITIVE-FIXATION PROTECTED-HELIX BIPOLAR ENDOCARDIAL LEADS TO BE USED IN CONJUNCTIO WITH AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR (AICD) PULSE GENERATORS
P920014|S004|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE(R) 1000A IP LVAS|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/1995|03/13/1996|||APPR|APPROVAL FOR REVISING THE LABELING TO DELETE THE HEMODYNAMIC CRITERIA FROM THE INDICATIONS FOR USE
P930034|S001|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)|LZS|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/1995|02/05/1997|||APPR|APPROVAL TO USE LASER VISION CORRECTION OR LVC AS A SYNONYM FOR PHOTOREFRACTIVE KERATECTOMY OR PRK IN YOUR LABELING.  THE APPLICATION IS APPROVED SUBJECT TO THE CONDITION THAT LVC WILL NOT BE USED IN THE FOLLOWING INSTANCES: 1)IN ADS TO PRACTITIONERS; 2)IN SECTION THAT CONTAIN THE APPROVED INDICATION, CONTRAINDICATION, WARNING, PRECAUTION, CAUTION, AND "A-J" STATEMENTS IN THE FDA APPROVAL ORDER DATED OCTOBER 20, 1995; 3) ON THE TITLE PAGE OF THE PATIENT INFORMATION BOOKLET; 4) AT THE BEGINNING OF TEXT IN A BOOKLET OR AN AD, UNTIL THE TERM "LASER VISION CORRECTION (LVC)" IS DEFINED AS A REPLACEMENT FOR PRK; AND 5) WHEN DISTINGUISHING THE VARIOUS SURGERIES, E.G., PTK AND PRK (NOT LVC).
P860027|S011|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM|LWP|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/1995|07/09/1996|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCEDURE
P890047|S010|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC VISCOELASTIC MATERIAL|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/1995|06/21/1996|||APPR|1)USE OF AN ALTERNATE STERILIZATION PROCESS USING 100% ETHYLENE OXIDE (ETO)/NITROGEN PURGE BY THE CONTRACT STERILIZER, STERI-TECH, INC. OF SALINAS, PUERTO RICO; 2)SHELF LIFE OF 24 MONTHS FOR VISCOAT AND 36 MONTHS FOR PROVISC AND 3)ALTERNATE PACKAGING FOR PROVISC
P880031|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|AMO(R) VITRAX(R) VISCOELASTIC SOLUTION|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/1995|04/09/1997|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE AT ALLERGAN BOTOX, LTD., WESTPORT, COUNTY MAYO, IRELAND; AN ALTERNATE CONTRACT STERILIZATION FACILITY, ISOTRON IRELAND, LTD., TULLAMORE, COUNTY OFFALY, IRELAND; AND AN 18 MONTH SHELF LIFE.
P880003|S056|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETERS AND CORDIS THOR PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/27/1995|04/23/1996|||APPR|APPROVAL FOR ADDITIONAL BALLOON SIZES FOR THE THOR PTCA DILATATION CATHETERS. THE ADDITIONAL BALLOON SIZES INCLUDE 2.75MM, 3.25MM, AND 3.75MM DIAMETERS AND 30MM LENGTHS
P840064|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT VISCOELASTIC SOLUTION|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/1995|06/21/1996|||APPR|1)USE OF ALTERNATE STERILIZATION PROCESS USING 100% ETHYLENE OXIDE (ETO)/NITROGEN PURGE BY THE CONTRACT STERILIZER, STERI-TECH, INC. OF SALINAS, PUERTO RICO; 2)SHELF LIFE OF 24 MONTHS FOR VISCOAT AND 36 MONTHS FOR PROVISC; 3) ALTERNATE PACKAGING FOR PROVISC
P800025|S005|Bio-Rad Laboratories, Inc.|3 Boulevard Raymond Poincare'||Marnes-la-Coquette||92430||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|QUANTITOPE 125I AFP KIT AND CONTROL SERUM|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1995|10/02/1996|||APPR|REPLACEMENT OF THE CURRENT RADIOLABELED AFP WITH A NEW AFP ANTIGEN
P900009|S003|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000|LPQ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/02/1996|03/27/1997|||APPR|APPROVAL FOR THE SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000(TM).
P840002|S008|CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|STAT-PACE II ESOPHAGEAL PACING SYSTEM|LPA|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/1996|05/07/1998|||APPR|
P880098|S009|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, extended wear|MENICON SF-P (MELAFOCON A) CONTACT LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/04/1996|04/03/1996|||APPR|APPROVAL FOR LABELING CHANGES INCLUDING ADDING TO THE APPROVED LABELING ALLERGAN INC.'S DESTAT 4 SYSTEM AND ALCON LABORATORIES, INC.'S OPTI-SOAK SYSTEM. NO FURHTER CHANGES WILL BE MADE IN THE LABELING.
P920004|S001|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (TM)|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/1996|08/01/1996|||APPR|APPROVAL FOR THE ADDITION OF A REDUCED TIME TO AMBULATION CLAIM TO THE INDICATIOS FOR USE
P900056|S014|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/1996|05/16/1996|||APPR|APPROVAL FOR THE SUPPORT ROTAWIRE AND RAIL ROTAWIRE GUIDE WIRES FOR USE WITH THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
P880003|S057|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETER, TITAN AND TITAN XL PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/16/1996|05/06/1996|||APPR|APPROVAL FOR 1)TITAN AND TITAN XL PTCA DILATATION CATHETERS WITH 4.5MM AND 5.0MM DIAMETER BALLOONS AVAILABLE IN 20MM LENGTHS; AND 2)A MODIFIED HUB BONDING PROCESS
P890025|S009|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY|MGU|TX|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/1996|04/01/1996|||APPR|NEW PROBE CLEANING PROCEDURE
P900056|S015|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL|MCX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/1996|04/23/1996|||APPR|ELIMINATION OF THE USP MOUSE SAFETY TEST AS A STERILIZATION LOAD RELEASE CRIETERIA
P860019|S110|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) 10MM & 20MM NC BANDIT(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/1996|02/26/1996|||APPR|APPROVAL FOR:1)10 AND 20 MM BALLOON LENGTHS; 2) 2.0 AND 2.25 DIAMETER BALLOONS IN THE 20 MM LENGTH; AND 3) THE USE OF AN EPOXY ADHESIVE FORTHE MANIFOLD BOND
P920032|S003|PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE|MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER|JOQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/1996|07/19/1996|||APPR|ALTERNATE VENDOR FOR THE CALIBRATED MODULE ASSEMBLY FOR THE MICRO-PACE MODEL 4553, PART NUMBER 02-025-000
P880072|S042|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES MODELS PA38E-OUV AND PL52A-OUV|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/1996|04/24/1996|||APPR|APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENSES MODELS PA38E-OUV AND PL52A-OUV.
P940031|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR(TM) DR PACEMAKER SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/1996|10/18/1996|||APPR|NEW PULSE GENERATOR MODE THE VIGOR(R) DR FAMILY OF PACEMAKER SYSTEMS
P910031|S007|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/1996|05/30/1996|||APPR|APPROVAL FOR: 1)AN ADDITIONAL MANUFACTURING SITE (13900 ALTON PARKWAY, SUITE 122, IRVINE, CA, 92718); 2) AN ALTERNATE STERILIZATION SITE (GRIFFITH MICRO SCIENCE, 4900 GIFFORD AVE., LOS ANGELES, CA, 90058); AND 3) AN INCREASE IN THE SHELF LIFE FROM ONE TO TWO YEARS
P930034|S002|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX PLUS EXIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1996|02/07/1997|||APPR|APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER SYSTEM.
P910067|S001|SUMMIT TECHNOLOGY, INC.|21 HICKORY DR.||WALTHAM|MA|02154||Excimer laser system|SVS APEX PLUS EXCIMER LASER WORKSTATION|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1996|02/07/1997|||APPR|APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER SYSTEM.
P810046|S161|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/1996|07/29/1996|||APPR|APPROVAL FOR THE ACS OTW LIFESTREAM CORONARY DILATATION CATHETER WITH A 30 MM BALLOON LENGTH
P870072|S001|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/1996|07/10/1996|||APPR|APPROVAL FOR ADDING REFERENCES TO THE DIRECTIONS FOR USE FOR THE THORATEC VAD SYSTEM
P910020|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY/DASH/STRIDE/DART PACING SYSTEMS|DXY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/1996|03/03/1996|||APPR|APPROVAL FOR THE INTRODUCTION OF LABELING ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:RELAY:293-03/294-03/294-03R  --  DASH:291-03/292-03/292-03R  --  STRIDE:294-05  --  DART:292-05  --  UNITY-C:292-06
P860007|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH(R)II MODELS 262-16|LWW|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/1996|03/22/1996|||APPR|APPROVAL FOR THE INTRODUCTION OF LABELNG ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:INTERTACH II 262-16/262-16R
P830026|S066|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX5000(TM) PROGRAMMER|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/1996|03/22/1996|||APPR|APPROVAL FOR THE INTRODUCTION OF LABELING ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY, THE FOLLOWING MODELS ARE AFFECTED:COSMOS II 284-05/283-03  --  NOVA II 282-04/281-05/281-05S/282-04R/282-04Y  --  QUANTUM II 254-30/253-25  --  NOVA III 282-09/282-09R/282-07/281/07  --  QUANTUM III 254-27  --  SUPRIMA III 254-31
P940029|S001|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|PAPNET (R) TESTING SYSTEM|MNM|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/31/1996|10/21/1996|||APPR|APPROVAL FOR A SECOND INDICATION FOR USE
P920015|S009|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC TRANSVENE LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/1996|04/08/1996|||APPR|APPROVAL FOR THE MODEL 6707 ADAPTER
P940008|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS|LWS|CV|Normal 180 Day Track|Other Report|N|02/05/1996|08/20/1996|||APPR|APPROVAL FOR A SUPPLEMENT WHICH SATISFIES THE REQUIREMENT TO SUBMIT A POST-APPROVAL STUDY PROTOCOL FOR THE INTERMEDICS EPICARDIAL PATCH DEFIBRILLATION LEADS. THE POST APPROVAL STUDY WAS REQUIRED AS A CONIDTIN OF APPROVAL IN OUR LETTER DATED NOVEMBER 7, 1995
N18033|S028|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON  (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS|LPM|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/1996|03/05/1996|||APPR|APPROVAL FOR UTILIZING AN ALTERNATE PROTOCOL FOR ESTABLISHING SHELF-LIFE STABILITY
P780007|S041|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|POLYMACON CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/1996|09/27/1996|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE REFERENCED DEVICE AT RELIANT CLOSE, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE, S053 4ND, ENGLAND
P870076|S004|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM|KNH|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/1996|06/14/1996|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE ON CIRCON-CABOT MEDICAL'S RACINE, WISCONSIN FACILITY FOR 1) DISPOSABLE FALOPE-RING APPLICATOR KIT WITH 8MM TROCAR DISPOSABLE TROCAR, AND CANNULA: BOX OF 8 STERILE PROCEDURE KITS (RE-ORDER NUMBER 005280-901); AND 2) DISPOSABLE FALOPE-RING APPLICATOR KIT WITHOUT 8MM TROCAR, DISPOSABLE TROCAR, AND CANNULA: BOX OF 8 STERILE PROCEDURE KITS (RE-ORDER NUMBER 006889-901)
P900060|S012|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/1996|03/07/1997|||APPR|APPROVAL FOR A VALVED GRAFT VERSION OF THE CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARBOMEDICS(R) CARBO-SEAL(TM) ASCENDING AORTIC PROSTHESIS (AAP) AND IS INDICATED FOR USE IN OPEN HEART SURGERY FOR SIMULTANEOUS REPLACEMENT OF THE ASCENDING AORTA AND THE AORTIC VALVE IN CASES OF ANEURYSM, DISSECTION, OR OTHER DISEASE CONDITIONS OF HTE AORTA COMBINED WITH DISEASE OR DEGENERATION OF THE AORTIC VALVE.  THE DEVICE IS AVAILABLE IN THE SIZES OF 21, 23, 25, 27, 29, 31, AND 33 MM.
P870025|S005|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR|MCP|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/1996|07/17/1996|||APPR|APPROVAL FOR A LABELING CHANGE TO PERMIT INTERFACE OF THE COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR WITH THE COROMETRICS MODEL 155 FETAL MONITOR
P890003|S043|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC THERA, PRODIGY AND PREVA PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/1996|07/01/1996|||APPR|APPROVAL FOR MARKETING OF A SUBSET OF PULSE GENERATROS FROM THE APPROVED THERA-I/PRODIGY HARDWARE AND SOFTWARE PLATFORMS. THE DEVICES AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES:MEDTRONIC:THERA MODEL 7968I PULSE GENERATOR; PRODIGY MODEL 8158 PULSE GENERATOR; PREVA MODELS 7088, 7089, 8088, AND 8089 PULSE GENERATORS; MODELS 9898E AND 9899E SOFTWARE - VITATRON:LEGACY II MODELS 126/128/526/528/726/728/826/828 PULSE GENERATORS; VISA MODELS 115/116/415/416/425/426/435/436 PULSE GENERATORS; AND MODEL 9849E SOFTWARE
P910031|S008|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|FACT(TM) BALLOON CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/1996|09/17/1996|||APPR|APPROVAL FOR THE ENDOSONICS ORACLE MEGASONICS PTCA CATHETER
P880027|S038|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|ASUKA AND ASUKA LONGY OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/1996|06/12/1996|||APPR|APPROVAL FOR THE ASUKA AND ASUKA LONGY OVER-THE-WIRE PTCA CATHETERS
P890023|S006|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/1996|10/02/1996|||APPR|ALTERNATE MANUFACTURING FACILITY AT RELIANT CLOSE, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE, S053 4ND, ENGLAND
P900061|S022|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/15/1996|07/01/1996|||APPR|APPROVAL FOR MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL WITH THE MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894 SOFTWARE
P910066|S002|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/1996|01/03/1997|||APPR|APPROVAL FOR A LABELING CHANGE FOR THE DEVICE TO REFERENCE THE RESULTS OF AN EXPANDED PATIENT DATA REGISTRY FOR PATIENTS TREATED WITH THE DEVICE DURING THE FIRST TWO YEARS OF MARKETING FOR THE APPROVED INDICATION.
P840001|S040|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/1996|04/25/1997|||APPR|APPROVAL FOR DESIGN CHANGES FOR THE ITREL(R) SERIES OF NEUROLOGICAL PULSE GENERATORS, INCLUDING THE INTREL(R), ITREL(R) II, AND ITREL(R) 3.
P940008|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS||CV|Normal 180 Day Track|Other Report|N|02/20/1996|08/22/1996|||APPR|APPROVAL TO CONSIDER THE INFORMATION PROVIDED IN THIS SUPPLEMENT AS AN ALTERNATIVE RESPONSE TO THE CONDITIONS OF APPROVAL SET FORTH IN THE FDA LETTER DATED NOVEMBER 7, 1995. THE CONDITION REQUIRED THAT REMAINING MINOR SOFTWARE ANOMALIES BE CORRECTED
P900052|S004|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST|LNY|HO|Normal 180 Day Track||N|02/23/1996|05/23/1997|||APPR|APPROVAL FOR A CHANGE IN INDICATIONS FOR USE TO INCLUDE LONG-TERM, REPEATED ACCESS TO THE EPIDURAL SPACE FOR THE DELIVERY OF PRESERVATIVE-FREE MORPHINE SULFATE TO RELIEVE CHRONIC INTRACTABLE PAIN OF NON-MALIGNANT ORIGIN.
P940034|S001|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|MWA|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/1996|04/23/1996|||APPR|APPROVAL FOR: 1)A COMPONENT (NALC) IN A LIQUID REAGENT (ENZYME DILUTION BUFFER) IS MOVED TO A LYOPHILIZED REAGENT (ENZYME REAGENT), RESULTING IN A STABILITY SHELF LIFE OF 1 YEAR FOR THE REAGENTS AND 1 YEAR FOR THE KIT; 2) ADD AN ADDITIONAL VENDOR OF REVERSE TRANSCRIPTASE; AND, 3) INSIGNIFICANT CHANGES TO THE PACKAGE INSERT
P840024|S061|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/1996|04/04/1996|||APPR|MODIFICATIONS TO THE AUDIO INPUT SELECTOR (AIS), AN OPTIONAL ACCESSORY FOR THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. MODIFICATIONS CONSIST OF REPLACING THE AUGAT, TYPE ASE/F/FO SERIES SWITCHES WITH AUGAT, TYPE MMS SERIES SWITCHES AND REMOUNTING RESISTORS R1 AND R2 TO THE SURFACE OF THE PCB
P890027|S030|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/1996|04/04/1996|||APPR|MODIFICATIONS TO THE AUDIO INPUT SELECTOR (AIS), AN OPTIONAL ACCESSORY FOR THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE MODIFICATIONS CONSIST OF REPLACING THE AUGAT, TYPE ASE/F/FO SERIES SWITCHES WITH AUGAT, YPE MMS SERIES SWITCHES AND REMOUNTING RESISTORS R1 AND R2 TO THE SURFACE OF THE PCB
P890057|S007|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/1996|12/20/1996|||APPR|APPROVAL FOR REPLACEMENT FLEXIBLE TUBING AND HEATED WIRE ACCESSORIES AND IS INDICATED FOR USE WITH MDOE 3100 AND 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR.
P870018|S013|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/1996|03/13/1996|||APRL|APPROVAL FOR MODIFICATIONS MADE TO THE ZOOM FUNCTION AND LABELING
P900060|S013|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/1996|08/27/1996|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE CONTROLLED ENVIRONMENT FOR CPHV MANUFACTURING OPERATIONS. THE ALTERNATE CONTROLLED ENVIRONMENT WILL BE LOCATED WITHIN YOUR EXISTING MANUFACTURING FACILITY IN CALGARY, ALBERTA, CANADA
P790017|S059|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) PROCROSS(TM) OVER-THE-WIRE BALLOON DILATION WITH RELY(TM) BALLOON MATERIAL AND HYDRO/PEL(R) COATING|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/1996|09/03/1996|||APPR|APPROVAL FOR USCI PROCROSS OVER-THE-WIRE BALLOON DILATATION CATHETER WITH RELY BALLOON MATERIAL AND HYDRO/PEL COATING
P900047|S005|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|CLARIS(TM) REWETTING DROPS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/1996|06/20/1996|||APPR|APPROVAL TO 1)DUPLICATE WET-N-SOAK REWETTING DROPS UNDER THE TRADE NAME CLARIS REWETTING DROPS TO BE USED WITH CLARIS CLEANING AND SOAKING SOLUTION (ALLERGAN'S TRADE NAME FOR DESTAT 4 CLEANING, DISINFECTING, STORAGE SOLUTION (P870023)) AND 2)ADD THE FOLLOWING TO THE DIRECTIONS SECTION FOR CLARIS REWETTING DROPS: BEFORE WEARING LENSES: PLACE 1 OR 2 DROPS OF CLARIS REWETTING DROPS ON EACH SIDE OF EACH LENS BEFORE APPLICATION
N12159|S016|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FIBRILLAR ABSORBABLE HEMOSTATT|LMG|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/1996|05/15/1996|||APPR|APPROVAL FOR THE 4"X4" SIZE OF SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT
P880027|S039|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|GOLDIE(TM) AND GOLDIE(TM) LONGY PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/1996|07/01/1996|||APPR|APPROVAL FOR THE GOLDIE AND GOLDIE LONGY PTCA CATHETER LINES
P790018|S027|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC-HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1996|08/19/1996|||APPR|APPROVAL FOR THE TRANSFER OF SEWING RING FABRICATION AND ATTACHMENT, AND STERILE PACKAGING MANUFACTURING PROCESSES FROM YOUR FACILITY LOCATED AT 7000 CENTRAL AVE., MINNEAPOLIS, MN TO YOUR FACILITY AT 18011 S.MITCHELL, IRVINE, CA
P810002|S041|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MECHANICAL HEART VALVE SJM(R) MASTER SERIES|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/1996|09/04/1996|||APPR|APPROVAL FOR A NEW STERILE PACKAGE SYSTEM FOR ALL OF THE ST. JUDE MEDICAL MECHANICAL HEART VALVE MODELS, AS DESCRIBED IN ATTACHMENT 1 OF YOUR SUBMISSION
P860007|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH II MODELS 262-16|LWW|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1996|08/19/1996|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS
P830026|S067|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS/NOVA/QUANTUM/SUPRIMA/PULSE GENERATORS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1996|08/19/1996|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS
P910020|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY/DASH/STRIDE/DART PACING SYSTEMS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1996|08/19/1996|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS
P930034|S003|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX APEX EXIMER LASER WORKSTATION|LZS|OP|Normal 180 Day Track|Other Report|N|03/12/1996|11/25/1996|||APPR|ALL LABELING MUST CONTAIN THE FOLLOWING PRECAUTION STATEMENT:  PRECAUTION: ALTHOUGH THE EFFECTS OF PRK ON VISUAL PERFORMANCE UNDER POOR LIGHTING CONDITIONS HAVE NOT BEEN DETERMINED, IT IS POSSIBLE THAT YOU WILL FIND IT MORE DIFFICULT THAN USUAL TO SEE IN CONDITIONS SUCH AS VERY DIM LIGHT, RAIN, SNOW, FOG, OR GLARE FROM BRIGHT LIGHTS AT NIGHT.
P830045|S051|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PHOENIX 2 AND PARAGON II PACING SYSTEMS|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/1996|10/09/1996|||APPR|MODIFICATION OF LABELING TO INCLUDE A "CELLULAR TESTED" LOGO TO THE SHELF PACKAGE OF THE FOLLOWING PACEMAKER MODELS: PHOENIX 2 (2005/2008/2009), PARAGON (2010/2011/2012), PARAGON II (2016), SYNCHRONY (2020), SYNCHRONY II (2022/2023), SYNCHRONY III (2028/2029), SOLUS (2002/2003), SOLUS II (2006/2007), TRILOGY (2350/2308/2250) AND REVISION OF THE PATIENT MANUAL TO INCLUDE THE LOGO AND LANGUAGE INFORMING THE PATIENT THAT NO SPECIAL CELL PHONE PRECAUSTIONS NEED BE TAKEN BY PATIENTS RECEIVING THESE MODELS
P880086|S035|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/1996|10/09/1996|||APPR|MODIFICATION TO THE LABELING TO INCLUDE A "CELLULAR TESTED" LOGO TO THE SHELF PACKAGE OF THE FOLLOWING PACEMAKER MODELS: PHOENIX 2 (2005/2008/2009), PARAGON (2010/2011/2012), PARAGON II (2016), SYNCHRONY (2020), SYNCHRONY II (2022/2023), SYNCHRONY III (2028/2029), SOLUS (2002/2003), SOLUS II (2006/2007), TRILOGY (2350/2308/2250) AND REVISION OF THE PATIENT MANUAL TO INCLUDE THE LOGO AND LANGUAGE INFORMING THE PATIENT THAT NO SPECIAL CELL PHONE PRECAUTIONS NEED TO BE TAKEN BY PATIENTS RECEIVING THESE MODELS
P870018|S014|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR LITHOTRIPTER SHOCK WAVE SYSTEM C|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/1996|06/06/1996|||APRL|APPROVAL FOR 1)MODIFICATIONS TO A PROGRAMMABLE READ ONLY MEMORY INTEGRATED CIRCUIT; AND 2)MINOR LABELING CHANGES. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR SHOCK WAVE SYSTEM C
P860059|S075|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/1996|05/30/1996|||APPR|APPROVAL FOR TIER A POSTERIOR CHAMBER LENSES, MODELS UPB38ON, UPB30OC, UPB320F, UPB320V, UPB330F, UPB382, AND UPB300F
P850035|S019|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/1996|11/15/1996|||APPR|TRANSFER OF THE TEST ANALYSIS FOR THE DEVICE FROM CARIBBEAN BIORESEARCH LABORATORIES AND GENEVA LABORATORIES TO ELECTRO-BIOLOGY, INC., IN GUAYNABO, PUERTO RICO
P790005|S038|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI ORTHOGEN(R)/OSTEOGEN(TM) IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/1996|11/15/1996|||APPR|TRANSFER OF THE TEST ANALYSIS FOR THE DEVICE FROM CARIBBEAN BIORESEARCH LABORATORIES AND GENEVA LABORATORIES TO ELECTRO-BIOLOGY, INC., IN GUAYNABO, PUERTO RICO
P890003|S044|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC 9891 BASELINE SOFTWARE/9891 A EPS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/1996|09/18/1996|||APPR|APPROVAL FOR THE MODELS 9891 AND 9891A PROGRAMMER SOFTWARE (BASELINE 7) FOR USE WITH THE MODEL 9790 AND 9790C PROGRAMMERS
P930029|S007|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/1996|09/06/1996|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC CARDIORHYTHM, SUNNYVALE, CA
P910023|S015|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/1996|03/03/1997|||APPR|APPROVAL FOR VENTRITEX(R) HOUSECALL(TM) SYSTEM WITH TRANSMITTER MODEL TR 2400 (SOFTWARE VERSION 1.1) AND RECEIVER MODEL RE 2400 (SOFTWARE VERSION 1.0)
P880086|S036|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L   PULSE GENERATORS MODELS 2360L AND 2364L|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/1996|09/30/1996|||APPR|APPROVAL FOR THE TRILOGY DR+ PACING SYSTEM INCLUDING MODELS 2360L AND 2364L, AND THE MODEL 3203A FUNCTION PACK
P830055|S047|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES|NJL|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/1996|05/06/1996|||APPR|COMBINATION LABELING TO INCLUDE THE CEMENTED AND CEMENTLESS DEVICE CONFIGURATIONS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM INTO ONE SINGLE LABEL
P900056|S016|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/22/1996|09/13/1996|||APPR|APPROVAL TO EXTEND THE SHELF LIFE OF THE A-19 ROTABLATOR ADVANCER/CATHETER FROM 2 YEARS TO 4 YEARS
P840068|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR MODEL 2880 SOFTWARE APPLICATION|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1996|11/07/1996|||APPR|1)NEW PROGRAMMING SYSTEM, WITH MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VIGOR FAMILY OF PULSE GENERATORS AND ACCESSORIES, AND 2)A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC., (EMD), 4065 THEURER BLVD., WINONA, MN 55987
P940031|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Programmer, pacemaker|MODEL 2901 PROGRAMMERR SYSTEM|KRG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1996|11/07/1996|||APPR|APPROVAL FOR 1)A NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VIGOR FAMILY OF PULSE GENERATORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING COTRACT FACILIYT, EMD ASSOCIATES, INC., (EMD), 4065 THEURER BLVD., WINONA, MN 55987
P880027|S040|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|CHUBBY(TM) PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1996|09/04/1996|||APPR|APPROVAL FOR THE CHUBBY SLIDING RAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
P910023|S016|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/1996|04/26/1996|||APPR|APPROVAL TO STERILIZE VENTRITEX PRODUCTS AT SOREX MEDICAL, INC., USING CHAMBER 9
P840008|S054|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER AND DORNIER LITHOTRIPTER TRANSPORTABLE|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/22/1996|10/08/1996|||APRL|APPROVAL FOR (I) A PATIENT AUTOMATIC POSITIONING FEATURE, (II) PATIENT DATA MANAGMENT SOFTWARE, (III) THE PERFORMA ULTRASOUND SYSTE, AND (IV) MINOR DEVICE MODIFICATIONS TO BOTH THE DORNIER LITHOTRIPTER AND THE DORNIER LITHOTRIPTER TRANSPORTABLE
P910023|S017|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/1996|09/25/1996|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION 4.1G OF THE PROGRAMMER MODEL PR-1500
P910077|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Programmer, pacemaker|MODEL 2901 PROGRAMMER|KRG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/1996|11/07/1996|||APPR|APPROVAL FOR A 1)NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VENTAK PRXII/PRXIII, MINI PULSE GENERTORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING  CONTRACT FACILITY, EMD ASSOCIATES, INC. (EMD), 4065 THEURER BLVD., WINONA, MN 55987
P880091|S007|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/1996|04/04/1997|||APPR|APPROVAL TO REVISE THE DIRECTIONS FOR USE INSERT TO RECOMMEND AN ADD'L INSERTION INSTRUMENT, THE MICROSTAAR(TM) INJECTION SYSTEM (MODELS MSI-TD AND MSI-PD)
P870023|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|CLARIS(R) CLEANING AND SOAKING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/1996|07/12/1996|||APPR|ALTERNATE MANUFACTURING SITE:ALLERGAN OPTICAL, 8301 MARS DRIVE, WACO, TEXAS 76712.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARIS CLEANING AND SOAKING SOLUTION
N50510|S070|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/1996|04/22/1996|||APPR|APPROVAL FOR THE ADDITION OF A LIMITATION STATEMENT REQUIRING A ALTERNATE METHOD OF TESTING FOR PIPERACLLIN IN SUSCEPTIBILITY TESTING OF PSEUDOMONAS AERUGINOSA
P940029|S002|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|PAPNET (R) TESTING SYSTEM|MNM|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1996|09/30/1996|||APPR|APPROVAL FOR MODIFICATIONS TO THE MAPPING UNTI USED IN THE PAPNET TESTING SYSTEM
P880028|S007|Hospira, Inc.|275 NORTH FIELD DR.|DEPT. 389, BLDG. H2-2|LAKE FOREST|IL|60045||FLUID, HYSTEROSCOPY|DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM|LTA|OB|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/1996|09/05/1996|||APPR|APPROVAL TO ALLOW FOR THE ROUTINE PARAMETRIC RELEASE OF TERMINALLY MOIST-HEAT STERILIZED SOLUTIONS BY THE OCNTROL OF PROCESS PARAMETERS FOR DEXTROSE HM 32%
P860023|S010|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/03/1996|09/27/1996|||APPR|APPROVAL FOR MODIFYING THE CURRENT EYE CARE PRACTITIONER TRIAL LENS DISINFECTION AND STORAGE INSTRUCTIONS TO EXTEND THE MAXIMUM RECOMMENDED STORAGE TIME FROM THE CURRENTLY APPROVED 7 DAYS TO 30 DAYS IN BAUSCH & LOMB RE NU MULTI-PURPOSE SOLUTION. ALL OTHER ASPECTS OF THE LABELING REMAIN UNCHANGED FROM THOSE PREVIOUSLY APPROVED
P900023|S018|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/1996|05/02/1996|||APPR|APPROVAL TO CLARIFY THE LABELED INDICATION FOR THE BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
P900061|S023|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC JEWEL CARDIOVERTER DEFIBRILLATOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1996|09/25/1996|||APPR|APPROVAL FOR MODEL 9895E APPLICATION SOFTWARE, VERSION T6E6V3, FOR MODEL 9790 AND 9790C PROGRAMMERS WHICH PROGRAM THE MODELS 7616/7217, 7201, 7219/02 AND 7220 IMPLANTABLE ARRHYTHMIA MANAGEMENT DEVICES
P940013|S005|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, daily wear|PRECISION(TM) UV (VASURFILCON)|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1996|10/07/1996|||APPR|APPROVAL FOR THE TINTING OF THE DEVICE WITH AN ALTERNATE, NON-REACTIVE, LIGHT BLUE-GREEN LOCATOR TINT (D&C GREEN NO. 6, C.I. NO. 61565) USING AN IN-MONOMER TINTING PROCESS FOR THE PRECISION(TM) UN (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR
P930031|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT(R) TIPS ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/1996|10/07/1996|||APPR|ADDITION OF THE 12 MM DIAMETER STENT, AND THE HALO(TM) RADIOPAQUE WIRE
P860059|S076|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|TIER A LENS MODELS UPB360GN AND UP320F|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/1996|09/17/1996|||APPR|APPROVAL OF MODELS UPB360GN AND UP320F AS TIER A MODIFICATIONS OF PREVIOUSLY APPROVED PARENT IOLS. MODEL UPB360GN WILL BE MARKETED UNDER THE TRADE NAME TOP NOTCH
P870015|S022|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/1996|08/19/1996|||APRL|APPROVAL FOR HARDWARE AND SOFTWARE CHANGES TO YOUR MEDSTONE STS LITHOTRIPTER
P910066|S004|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC 1000 BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/1996|06/25/1997|||APPR|APPROVAL FOR THE ORTHOLOGIC 1000 SINGLE CLOSED COIL SOFT PACK BONE GROWTH STIMULATOR IN SIZES XS, S, M, L, AND XL AND FOR THE ORTHOLOGIC 1000 BONE GROWTH STIMULATOR IN THE MEDIUM SIZE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES OL 1000-CC AND OL 1000 (MEDIUM) AND ARE INDICATED FOR THE NONINVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VETEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED.
P940022|S001|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342|||CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/1996|08/02/1996|||APPR|APPROVAL TO MODIFY THE DESIGN OF THE CLARION MULTI-STRATEGY COCHLEAR IMPALTN FROM THE ORIGINAL 1.0 VERSION TO THE MINIATURIZED 1.2 VERSION
P820003|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 5388 TEMPORARY PACEMAKER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/1996|03/27/1997|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 5388 TEMPORARY PACEMAKER
P910023|S018|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADET TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/1996|06/11/1996|||APPR|APPROVAL FOR TWO HEADER CONFIGURATIONS (MODELS V-105/V115 AND MODELS V-105B/V-115B, AS PART OF THE CADET TIERED THERAPY DEFIBRILLATOR SYSTEM
P870072|S002|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/1996|05/01/1996|||APPR|APPROVAL TO ADD AN INCOMING INSPECTION TEST TO THE QUALITY ASSURANCE PROCEDURES FOR EPROM INTEGRATED CIRCUITS
P870018|S015|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|MOBILE LITHOSTAR WITH SHOCK WAVE SYSTEM C (SWSC)|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/11/1996|06/05/1996|||APRL|APPROVAL FOR A MOBILE VERSION OF THE LITHOSTAR SHOCK WAVE SYSTEM C. THE DEVICE AS MODIFIED, WILL BE MARKEDTED UNDER THE TRADE NAME MOBILE LITHOSTAR SHOCK WAVE SYSTEM C
P900056|S017|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/12/1996|09/27/1996|||APPR|APPROVAL FOR REVISED PRODUCT LABELING
P810002|S042|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/1996|05/14/1996|||APPR|APPROVAL FOR LABELING CHANGE TO THE ST. JUDE MEDICAL COATED AORTIC VALVED GRAFT (CAVG), MODEL CAVG-404. THE WARNING WILL INSTRUCT THE PHYSICIAN TO WET THE GRAFT WITH SLINE BEFORE CAUTERIZING IN ORDER TO PREVENT IGNITION
P860057|S004|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/1996|10/17/1996|||APPR|MODIFICATION OF YOUR STERILIZATION PROCESS TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PORCESS AND REPLACE IT WITH A TERMINAL STERILIZATION PROCESS
P870077|S003|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/1996|10/17/1996|||APPR|MODIFICATION OF YOUR STERILIZATION PROCESS TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PROCESS AND REPLACE IT WITH A TERMINAL STEERILIZATION PROCESS
P870056|S003|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/1996|10/17/1996|||APPR|MODIFICATION OF YOUR STERILIZATION PROCES TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PROCESS TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PROCESS AND REPLACE IT WITH A TERMINAL STERILIZATION PROCESS
P920051|S003|KARL STORZ ENDOSCOPY-AMERICA, INC.|1201 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|STORZ MODULITH LITHOTRIPTER, MODEL SLX|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/17/1996|06/21/1996|||APRL|APPROVAL FOR A NEW MODEL LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH LITHOTRIPTER, MODEL SLX
P810046|S162|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX STREAK & ACS FLOW TRACK 40|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/1996|11/05/1996|||APPR|APPROVAL FOR THE ADDITION OF NEW PRODUCT NAMES TO ALLOW CONCURRENT DISTRIBUTIO BY A SECOND COMPANY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ACS RX GAZELLE CORONARY DILATATION CATHETER AND ACS RX FLEXFLO CORONARY DILATATION CATHETER
P870036|S038|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/1996|09/25/1996|||APPR|APPROVAL FOR THE INTRODUCTION OF A NEW PRODUCT LINE. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MILLENIA CORONARY BALLOON DILATATION CATHETER
P860019|S111|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) SURPASS(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/1996|07/01/1996|||APPR|APPROVAL FOR THE SCIMED SURPASS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PERFUSION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED FOR THE BALLOON DILATATION OF THE STENOTIC PORTIO OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION
P880091|S008|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|UV-ABSORBING ELASTIMIDE(TM) MODELS AQ-1016VL, AQ-2003VL, AQ-2010VL POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/1996|10/17/1996|||APPR|APPROVAL FOR TIER A MODELS A1-1016VL, AQ-2003VL, AND AQ-2010VL
P810046|S163|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS(R) PINKERTON .018(TM) CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/1996|09/13/1996|||APPR|APPROVAL FOR THE ACS PINKERTON .018 CORONARY DILATATION CATHETER WITH THE 4.5 MM AND 5.0 MM BALLOON LENGTHS
P890001|S016|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/1996|09/17/1996|||APPR|APPROVAL FOR THE LEOCOR 30 MM PICO RUNNER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
P910023|S019|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADET(TM) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/19/1996|05/07/1996|||APPR|APPROVAL FOR THE CADET TIERED THERAPY DEFIBRILLATOR SYSTEM (PECTORAL USE)
P910020|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|MARATHON PACING SYSYTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/1996|10/16/1996|||APPR|APPROVAL FOR THE RX5000 VERSION 2.00.01 SOFTWARE FOR USE WITH THE RX5000 MODEL 522-12 PROGRAMMER TO PROGRAM THE MARATHON PACING SYSTEM.
P870015|S024|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR|LNS|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/1996|05/24/1996|||APRL|APPROVAL FOR REVISION OT THE "PRECAUTIONS" SECTION OF THE USER'S MANUAL
P840024|S062|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1996|05/20/1996|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXTERNAL TRANSMITTER COIL OF THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE MODIFICATIONS CONSIST OF CONNECTING TWO DIODES IN PARALLEL WITH THE EXTERNAL TRANSMITTER COIL TO LIMIT ESD ENERGY BEING TRANSMITTED TO THE IMPALNT BY THE COIL. A CHANGE IN THE MANUFACTURING METHOD FOR THE COIL WINDINGS WILL ALSO REDUCE THE EFFECTIVE COIL DIAMETER BY APPROXIMATELY 0.1MM.
P890027|S031|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1996|05/20/1996|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXTERNAL TRANSMITTER COIL OF THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE MODIFICATIONS CONSIST OF CONNECTING TWO DIODES IN PARALLEL WITH THE EXTERNAL TRANSMITTER COIL TO LIMIT ESD ENERGY BEING TRANSMITTED TO THE IMPLANT BY THE COIL. A CHANGE IN THE MANUFACTURING METHOD FOR THE COIL WINDINGS WILL ALSO REDUCE THE EFFECTIVE COIL DIAMETER BY APPROXIMATELY 0.1MM.
P900061|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7223CX MICRO JEWEL II(TM)|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1996|11/08/1996|||APPR|APPROVAL FOR MEDTRONIC MODEL 7218 B/C/D/E WITH THE MODEL 9896 SOFTWARE AND THE MEDTRONIC MODEL 7223 CX MICRO JEWELL II WITH MODEL 5705 ACTIVE CAN EMULATOR AND MODEL 9955 SOFTWARE
P930016|S001|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX EXCIMER LASER SYSTEM MODELS B AND C|LZS|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/18/1996|10/15/1996|||APPR|LABELING CHANGES (I.E., MINOR EDITORAL CHANGES TO THE PATIENT INFORMATION BOOKLET, CONTRAST SENSITIVITY/GLARE PRECAUTIONARY STATEMENT IN LIEU OF A POSTAPPROVAL CONTRAST SENSITIVITY STUDY, AND DEFINITIONS OF POTENTIAL RISKS WITH PRK)
P890027|S032|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/25/1996|06/13/1996|||APPR|APPROVAL FOR REVISIONS TO THE WARNING SECTION IN THE PACKAGE INSERT AND PATIENT IDENTIFICATION CARD FOR THE NUCLEUS 22 COCHLEAR IMPLANT SYSTEM. THE REVISIONS CLARIFY THE WARNING ON THE USE OF MONOPOLAR ELECTROSURGICAL INSTRUMENTS ON IMPLANT PATIENTS AND PROVIDES ADD'L INSTRUCTIONS FOR THE SAFE USE OF BIPOLAR INSTRUMENTS
P840024|S063|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/25/1996|06/20/1996|||APPR|APPROVAL FOR REVISIONS TO THE WARNINGS SECTION IN THE PACAKGE INSERT AND PATIENT IDENTIFICATION CARD FOR THE NUCLEUS 22 COCHLEAR IMPLANT SYSTEM. THE REVISIONS CLARIFY THE WARNING ON THE USE OF MONOPOLAR ELECTROSURGICAL INSTRUMENTS ON IMPLANT PATIENTS AND PROVIDES USE OF MONOPOLAR ELECTROSURGICAL INSTRUMENTS ON IMPLANT PATIENTS AND PROVIDES ADDTIONIAL INSTRUCTIONS FOR THE SAFE USE OF BIPOLAR INSTRUMENTS
P860005|S005|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)|MBS|OR|Normal 180 Day Track|Other Report|N|04/29/1996|07/18/1996|||APPR|APPROVAL FOR A REVISION TO THE POST-MARKET STUDY PROTOCOL
P860019|S112|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED RANGER PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/1996|08/29/1996|||APPR|APPROVAL FOR THE SCIMED RANGER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTCA) CATHETER
P880003|S059|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS|LOX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/1996|06/05/1996|||APPR|APPROVAL FOR A MODIFIED BALLOON FOLDING MACHINE
P900023|S019|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/1996|08/19/1996|||APPR|APPROVAL TO ELIMINATE THE ISOLATOR VALVE ASSEMBLY FROM THE BVS CONSOLE
P910075|S007|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COMPLETE BRAND LUBRICATING AND REWETTING DROPS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1996|09/13/1996|||APPR|APPROVAL FOR A FORMULA MODIFICATION THAT INCLUDES THE ADDTION OF HYDROXYPROPYL METHYLCELLULOSE TO THE FORMULATION OF THE DEVICE. THE INDICATIONS FOR USE REMAIN UNCHANGED
P860019|S113|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1996|04/09/1997|||APPR|APPROVAL FOR A NEW BALLOON DILATATION AND INFUSION CATHETER.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SCIMED(R) TRANSPORT(R) CORONARY BALLOON DILATATION-INFUSION CATHETER AND IS INDICATD FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FO RTHE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE TRANSPORT(R) CATHETER IS ALSO INTENDED TO INFUSION FLUIDS SUCH AS HEPARINIZED SALINE, AND THROMBOLYTIC AGENTS SUCH AS UROKINASE, INTOT EH VASCULATURE WHEN THE DILATATION BALLOON IS DEFLATED OR INFLATED TO PRESSURES UP TO 3 ATMOSPHERES.
P830061|S026|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) POLYURETHANE STEROID-ELUTING LEAD|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/1996|08/12/1996|||APPR|ALTERNATE PACKAGING DESIGN
P860059|S077|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|IOPTEX PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/1996|10/07/1996|||APPR|REDUCTION OF THE INCUBATION TIME FOR BIOLOGICAL INDICATORS USED IN STERILITY TESTING
P850089|S034|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC SILICONE STEROID-ELUTING LEAD|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/1996|08/12/1996|||APPR|ALTERNATIVE PACKAGING DESIGN
P930039|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) SCREW-IN STEROID ELUTING LEAD|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/1996|08/12/1996|||APPR|ALTERNATIVE PACKAGING DESIGN
P890003|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC VDD STEROID-ELUTING LEAD|DXY|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/1996|08/12/1996|||APPR|ALTERNATIVE PACKAGING DESIGN
P840024|S064|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/1996|06/13/1996|||APPR|APPROVAL FOR A REDESIGN OF THE MINI COCHLEAR IMPLANT'S INTEGRATED CIRCUIT (IC2401)
P890027|S033|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/1996|06/13/1996|||APPR|APPROVAL FOR A REDESIGN OF THE MINI COCHLEAR IMPLANT'S INTEGRATED CIRCUIT (IC2401)
P850007|S018|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM LITE BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/07/1996|04/16/1997|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN AND LABELING OF THE PHYSIO-STIM(R) BONE GROWTH STIMULATOR.  THE DEVICE, AS MODIFIED, IS TO BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM(R) LITE AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING BERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED.  A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE INJURY AND THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HELAING FOR A MINIMUM OF THREE MONTHS (NO CHANGE IN THE FRACTURE CALLUS)
P860004|S035|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/08/1996|09/10/1996|||APPR|APPROVAL TO ADD TO THE LABELING FOR THE 10 CC SYNCHROMED IMPLANTABLE PROGRAMMABLE INFUSION PUMP, MOELS 8616-10 AND 8617-10 THE FOLLOWING INDICATIONS:1)THE CHRONIC INTRASPINAL (EPIDURAL/INTRATHECAL) INFUSION OF PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION IN THE TREATEMTN OF CHRONIC INTRACTABLE PAIN; 2)THE CHRONIC INTRAVASCULAR INFUSION OF FLOXURIDINE, DOXORUBICIN, CISPLATIN, OR METHOTREXATE FOR THE TREATEMENT OF PRIMARY OR METASTATIC CANCER; AND 3)THE INTRAVENOUS INFUSION OF CLINDAMYCIN FOR THE TREATMENT OF OSTEOMYELITIS
P920023|S001|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT|UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS|MER|GU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/06/1996|04/11/1997|98M-0050|02/09/1998|APPR|APPROVAL FOR THE UROLUME(TM) ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY(BPH).  THIS DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YRS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.5CM IN LENGTH.
P890064|S004|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY|MAQ|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/03/1996|08/28/1996|||APPR|APPROVAL FOR CHANGES IN MANUFACTURING METHODS AND PROCEDURES, AND LABELING MODIFICATIONS
P850089|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS|DTB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/1996|03/07/1997|||APPR|APPROVAL FOR THE USE OF NUSIL MED-4719 AS AN ALTERNATE SILICONE INSULATOR FOR MDX4-4516
P800034|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|CLERZ LUBRICATING & REWETTING EYE DROPS|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/1996|09/24/1996|||APPR|APPROVAL FOR A STABILITY TESTING PROTOCOL
P790007|S013|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE II AORTIC BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/13/1996|12/10/1996|||APPR|APPROVAL FOR TWO ADD'L STYLES (TYPE F AND TYPE G) OF THE MODEL 250 VALVE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES HANCOCK(R) MODIFIED ORIFICE II AORTIC BIOPROSTHESIS, MODEL 250, EXTENDED SUPRA-ANNULAR FLANGE (TYPE F) AND HANCOCK(R) MODIFIED ORIFICE II AORTIC BIOPROSTHESIS, MODEL 250, SUPRA-ANNULAR FLANGE (TYPE G). THE INDICATION FOR USE AND AVAILABLE SIZES (19, 21, 23, AND 25 MM) FOR THE MDOEL 250 VALVES HAVE NOT CHANGED.
P860047|S011|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1996|11/08/1996|||APPR|EXTENSION OF THE SHELF LIFE FOR OCUCOAT FROM 18 MONTHS TO TWO YEARS
P820021|S029|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/10/1996|09/25/1996|||APPR|APPROVAL FOR REVISED LABELING (I.E., PACKAGE INSERT, PRACTITIONER FITTING GUIDE, AND SEPARATE PATIENT INFORMATION BOOKLETS FOR LENSES PRESCRIBED FOR FREQUENT REPLACEMENT WEAR (FOCUS, FOCUS TORIC, AND NEWVUES (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES) AND DISPOSABLE WEAR (NEWVUES (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES). REVISIONS INCLUDED (1)MERGING PLANNED REPLACEMENT AND DISPOSABLE WEARING SCHEDULES FOR THE LENSESE INTO ONE PACKAGE INSERT AND DIRECTING THE PACKAGE ISERT TO THE EYECARE PRACTITIONER, (2)WRITING SEPARATE PATIENT INSTRUCTIONS FOR LENSES PRESCRIBED FOR DISPOSABLE AND FREQUENT REPLACEMENT WEAR, (3)UPDATING THE PROFESSIONAL FITTING GUIDE FOR CONSISTENCY WITH OTHER LABELING ITEMS, AND (4)BRINGING THE LABELING UP-TO-DATE WITH FDA'S CURRENT RECOMMENDATIONS IN AN EFFORT TO INCREASE CONSUMER COMPREHENSION AND COMPLIANCE. THE REVISIONS DO NO RESULT IN CHANGES IN THE DEVICES THEMSELVES OR THE INDICATIONS FOR USE OF THE DEVICES
P910077|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|05/10/1996|05/15/1996|||APPR|APPROVAL FOR THE VENTAK PRX AICD (MODELS 1700 AND 1705), VENTAK PRX II AICD MODEL 1715, VENTAK PRX III AICD (MODELS 1720 AND 1725), VENTAK MINI AICD (MODELS 1645, 1740, 1741, 1745, AND 1746), VENTAK MINI HC AICD (MODELS 1742, 1743 AND 1640), AND VENTAK MINI AICD (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE
P930035|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|05/10/1996|05/15/1996|||APPR|APPROVAL FOR THE VENTAK P2 AICD MODEL 1625 AND THE VENTAK PC AICD MODELS 1630 AND 1635 WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE
P910073|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/10/1996|05/15/1996|||APPR|APPROVAL FOR THE ENDOTAK C LEAD (MODELS 0060, 0062, 0064, 0065, 0066, 0067, AND 0068), ENDOTAK SQ PATCH LEAD (MODEL 0047 AND 0063), ENDOTAK C LEAD (MODELS 0070, 0072, 0073, 0074, 0075, 0113, AND 0115), ENDOTAK SQ LEAD ARRAY (MODELS 0048 AND 0049), AND ENDOTAK DSP LEAD (MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125), WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE
P950014|S001|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/1996|06/20/1996|||APPR|APPROVAL TO SUPPLY THE PROSTATRON TREATMENT CATHETER (I.E., THE PROSTAPROBE) IN STERILE FORM
P930016|S002|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX EXCIMER LASER SYSTEM MODELS B AND C|LZS|OP|Normal 180 Day Track|Other Report|N|05/16/1996|11/07/1996|||APPR|APPROVAL FOR: 1)A PROTOCOL FOR A PROSPECTIVE POSTAPPROVAL STUDY TO DETECT RARE BUT SERIOUS ADVERSE EVENTS; AND, 2)CHANGES TO UPDATE YOUR PHASE III PRK PROTOCOL FOR POSTAPPROVAL FOLLOW-UP PURPOSES. FDA ACKNOWLEDGES THAT SUPPLEMENT 1 (APPROVED ON 15-OCT-96) NEGATES THE NEED FOR A CONTRAST SENSITIVITY/GLARE STUDY OR PROTOCOL. PLEASE NOTE THAT LONG-TERM DATA MUST BE REFLECTED IN THE LABELING (VIA A SUPPLEMENT TO THE PMA) WHEN THE ADD'L FOLLOW-UPS AND/OR POSTAPPROVAL STUDIES ARE COMPLETED
P930031|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT(R) TIPS ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/13/1996|01/03/1997|||APPR|APPROVAL FOR MODIFYING THE WIRE DIAMETER AND NUMBER OF WIRES IN THE 12 MM DIAMETER STENT, AND CORRECTS THE ACTUAL LENGTH TO BE MARKETED.
P910031|S009|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1996|08/20/1996|||APPR|APPROVAL FOR THE 22 MM MODELS OF THE FACT AND ARC BALLOON CORONARY DILATATION CATHETERS
P830045|S052|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1996|11/19/1996|||APPR|APPROVAL FOR THE MODEL 3203A FUNCTION PACK FOR USE WITH THE APS II PROGRAMMER
P880006|S024|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/1996|10/30/1996|N||APPR|APPROVAL FOR THE MODEL 3203A FUNCTION PACK FOR USE WITH THE APS II PROGRAMMER
P870007|S011|OPTOPICS LABORATORIES CORP.|32 MAIN ST., P.O. BOX 210||FAIRTON|NJ|08320|0210|Accessories, soft lens products|SORBIC ACID PRESERVED SALINE SOL.PH CHANGE|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1996|11/13/1996|||APPR|APPROVAL TO MARKET THE DEVICE IN A 16 FL. OZ. CONTAINER SIZE
P870018|S016|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/1996|06/21/1996|||APRL|APPROVAL FOR MODIFYING YOUR USER'S MANUAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR
P890003|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC 9766A/9766AL PROGRAMMING HEAD|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1996|10/30/1996|||APPR|APPROVAL FOR THE MODEL 9766AQ AND MODEL 9766AL PROGRAMMER HEADS FOR USE WITH THE MODEL 9790 AND MODEL 9790C PROGRAMMERS
P940034|S002|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|MWA|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/22/1996|06/05/1996|||APPR|APPROVAL FOR CHANGING THE PACKAGE INSERT TO INCLUDE MORE DETAILS ON ADEQUATE VORTEXING
P920015|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT TM MODEL 6932 LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/1996|08/06/1996|||APPR|APPROVAL FOR THE MEDTRONIC SPRINT MODEL 6932 LEAD
P920015|S011|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT TM MODEL 6932 LEAD|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/1996|07/26/1996|||APPR|APPROVAL FOR THE MEDTRONIC PUERTO RICO, INC., VILLALBA WEST INDUSTRIAL AREA, VILLALBA, PUERTO RICO TO MANUFACTURE THE MEDTRONIC MODEL 6932 LEAD
P880070|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL UV65 SERIES ANTERIOR CHAMBER LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1996|02/02/1998|||APPR|Approval for the use of an alternate sterilizer at the manufacturing site in Groningen, The Netherlands.
P810055|S066|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/1996|02/02/1998|||APPR|Approval for the use of an alternate sterilizer at the manufacturing site in Groningen, The Netherlands.
P800026|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/1996|09/24/1996|||APPR|APPROVAL FOR A STABILITY TESTING PROTOCOL
P880091|S009|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/1996|11/14/1996|||APPR|ADDITION OF AN ALTERNATE STEAM STERILIZER AND REVERSE OSMOSIS UNIT TO YOUR STERILIZATION PROCESS
P830056|S077|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|POSTERIOR CHAMBER INTROCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/1996|08/01/1996|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MENTOR CARIBE, LOT 2 JIBARO INDUSTRIAL PARK, CIDRA, PR 00639
P870051|S006|TRP COMPANY|1575 DELUCCI LANE #115||RENO|NV|89502||Accessories, soft lens products|SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/04/1996|06/02/1997|||APPR|Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
P870050|S006|TRP COMPANY|1575 DELUCCI LANE #115||RENO|NV|89502||Accessories, soft lens products|SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/1996|06/02/1997|||APPR|Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
P810046|S165|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS TX2000TM CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/1996|10/25/1996|||APPR|APPROVAL FOR THE ACS TX2000 CORONARY DILATATION CATHETER
P890055|S001|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/1996|06/27/1996|||APPR|APPROVAL FOR THE ADDITION OF THE "MODEL 3000 MEDICATION CALCULATOR" TO THE LABELING FOR THE M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
P950009|S002|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM|MNM|PA|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/06/1996|05/05/1998|98M-0521|08/12/1998|APPR|The AutoPap(R) Primary Screening System is an automated cervical cytology screening device intended for use in initial screening of Papanicolaou (Pap) smear slides.  The AutoPap(R) Primary Screening System identifies up to 25% of successfully processed slides as requiring no further review.  The AutoPap(R) Primary Screening System also identifies as least 15% of all successfully processed slides for a second manual review.  The device is to be used only on conventionally prepared Pap smear slides and is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as "high risk".  Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.
P950039|S001|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP(R) PROCESSOR|MKQ|PA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/1996|08/22/1996|||APPR|APPROVAL FOR RELOCATION OF CYTYC CORP., FROM 237 CEDAR HILL ST., MARLBOROUGH, MA TO 85 SWANSON RD., BOXBOROUGH, MA
P840024|S065|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1996|09/09/1996|||APPR|APPROVAL FOR IMPLEMENTING A TEST SYSTEM TO CONFIRM OR RULE OUT POTENTIAL IMPLANT MALFUNCTION AND FOR MARKETING OF ONE OF THE COMPONENTS OF THIS TEST SYSTEM AS A SEPARATE DEVICE
P890027|S034|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/1996|09/09/1996|||APPR|APRPOVAL FOR IMPLEMENTING A TEST SYSTEM TO CONFIRM OR RULE OUT POTENTIAL IMPLANT MALFUNCTION AND FOR MARKETING OF ONE OF THE COMPONENTS OF THIS TEST SYTEM AS A SEPARATE DEVICE
P820003|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 5348 TEMPORARY PACEMAKER KEYPAD COMPONENT|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/1996|07/16/1996|||APPR|APPROVAL FOR MODIFICATIONS TO THE KEYPAD OF THE MODEL 5348 TEMPORARY PACEMAKER
P850007|S019|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|SPINAL-STIM LITE SPINAL FUSION SYSTEM|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1996|09/19/1997|||APPR|Approval for the Spinal-Stim(R) Lite Spinal Fusion System, Model 212L.  The device will be marketed under the trade name Spinal-Stim(R) and is indicated as a spinal fusion adjunct to increase the probability of fusion success ans as a nonooperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
P910023|S020|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/14/1996|09/09/1996|||APPR|APPROVAL FOR THE VENTRITEX CONTOUR CARDIOVERTER DEFIBRILLATOR SYSTEM (MODELS V-145D AND LT MODEL V-135D, PROGRAMMER SOFTWARE VERSION 4.1.5. AND ACCESSORIES
P940034|S003|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|MWA|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/17/1996|08/22/1996|||APPR|APPROVAL FOR CHANGING THE PACKAGE INSERT FOR THE MTD KIT TO INCLUDE AN ADDITIONAL WARNING AND AN EXPANDED LIMITATION REGARDIGN LOW POSITIVE RESULTS WITH MOTT.
P860019|S114|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED NC BANDIT PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1996|08/27/1996|||APPR|APPROVAL FOR A MODIFICATION TO THE WRAP-IT ACCESSORY TOOL
P880085|S003|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|IOPTEX PMMA ANTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/1996|10/07/1996|||APPR|REDUCTION OF THE INCUBATION TIME FOR BIOLOGICAL INDICATORS USED IN STERILITY TESTING
P850079|S027|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|HYDRASOFT METHAFILCON B|LPM|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/1996|12/11/1996|||APPR|ALTERNATE MANUFACTURING PROCESS AND POLYMERIZATION METHOD
P840024|S066|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/1996|08/28/1996|||APPR|APPROVAL FOR IMPLEMENTING A NEW DIAGNOSTIC AND PROGRAMMING SYSTEM SOFTWARE. THIS VERSION OF SOFTWARE IS THE DPS VERSION 6.125.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM:DPS SOFTWARE VERSION 6.125.
P890027|S035|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/1996|08/28/1996|||APPR|APPROVAL FOR IMPLEMENTING A NEW DIAGNOSTIC AND PROGRAMMING SYSTEM SOFTWARE. THIS VERSION OF SOFTWARE IS THE DPS VERSION 6.125.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM, DPS SOFTWARE VERSION 6.125.
P900056|S018|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/1996|02/13/1997|||APPR|APPROVAL FOR THE ROTALINK(TM) EXCHANGEABLE CATHETER FOR THE ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM AND IS INDICATED FOR USE IN PATIENTS WITH CORONARY ARTERY DISEASE SHO ARE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG) SRUGERY AND WHO MEET ONE OF THE FOLLOWING CRITERIA:SINGLE VESSEL ATHEROSCLEROTIC CORONARY ARTERY DISEASE WITH A STENOSIS THAT CAN BE PASSED WITH A GUIDE WIRE; MULTIPLE VESSEL CORONARY ARTERY DISEASE THAT IN THE PHYSICIAN'S JUDGMENT DOES NOT POSE UNDO RISK TO THE PATIENT; CERTAIN PATIENTS WITH PREVIOUS PTCA, AND WHO HAVE A RESTENOSIS OF THE NATIVE VESSEL; OR NATIVE VESSEL ATHEROSCLEROTIC CORONARY ARTERY DISEASE THAT IS LESS THAN 25 MM IN LENGTH.
N17755|S047|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|OSTEOBOND(TM) COPOLYMER BONE CEMENT|LOD|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/1996|07/31/1996|||APPR|APPROVAL FOR THE ADDITION OF TERMINOLOGY OF "HALF BATCH, SINGLE BATCH, DOUBLE BATCH, HALF PACK, SINGLE PACK, AND DOUBLE PACK" TO THE PACKAGE LABELS FOR OSTEOBOND COPOLYMER BONE CEMENT
P920004|S002|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (TM)|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/1996|08/01/1996|||APPR|APPROVAL FOR A "SPECIAL PMA SUPPLEMENT - CHANGES BEING EFFECTED" AND PROVIDES FOR CHANGES TO THE INSTRUCTIONS FOR USE TO ENHANCE THE SAFETY OF THE USE OF THE DEVICE
P920004|S003|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (TM)|MGB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/1996|12/18/1996|||APPR|APPROVAL FOR DOSIMETRIC RELEASE OF VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE PRODUCTS.
P870036|S039|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1996|08/30/1996|||APPR|APPROVAL FOR NEW BALLOON SIZES TO BE ADDED TO THE FALCON 20 CORONARY BALLOON DILATATION CATHETER LINE AND THE ADDTION OF THE FALCON 30 AND FALCON 40 COROANRY BALLOON DILATATION CATHETER LINES. ALSO, SPECIFICATION AND QUALITY CONTROL INSPECTION CHANGES WERE REQUESTED
P930039|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/1996|01/02/1997|||APPR|APPROVAL FOR THE ADDITION OF MODEL 4067, 4568, 5067, 5068 AND 5568 TO THE CAPSUREFIX(R) LINE. THESE LEAD MODELS WILL ALSO BE DISTRIBUTED BY VIATRON, INC., UNDER THE TRADENAME "PIROUT" (MODELS IMU49, IMU49JB, IMX49, IMX49B AND IMU49JB).
P920048|S001|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|ADEZA FETAL FIBRONECTIN EIK|LKV|CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/1996|01/08/1997|||APPR|APPROVAL FOR A MODIFICATION OF THE INTENDED USE STATEMENT AS FOLLOWS:  "THE DEVICE IS FURTHER INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL INFO AS AN AID IN ASSESSING THE RISK OF PRETERM DELIVERY IN < 34 WEEKS, 6 DAYS WHEN A CERVICOVAGINAL SAMPLE IS OBTAINED DURING A ROUTINE PRENATAL VISIT BETWEEN 22 WEEKS, 0 DAYS AND 30 WEEKS, 6 DAYS OF GESTATION IN WOMEN WITH A SINGLETON GESTATION. THE POSITIVE PREDICTIVE VALUE RANGES FROM 13.3% TO 31.7% FOR DELIVERY IN < 34 WEEKS, 6 DAYS AND REPRESENTS AN APPROXIMATE 4- TO 7-FOLD INCREASE IN RISK OVER THE RELIABILITY OF PREDICTING DELIVERY GIVEN NO TEST INFO.  THE NEGATIVE PREDICTIVE VALUE RANGES FROM 96.4% TO 97.9% MAKING IT HIGHLY LIKELY THAT DELIVERY WILL NOT OCCUR IN THESE TIME FRAMES."
P810046|S166|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX COMET(TM) CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/1996|11/18/1996|||APPR|APPROVAL FOR ACS RX COMET(TM) CORONARY DILATATION CATHETER
P930012|S004|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/1996|11/18/1996|||APPR|ADDITION OF THE FOLLOWING BALLOON SIZES TO BE ADDED TO THE PAS CHAMPION(TM) PTCA CATHETER LINE:  2.5MM X 30MM; 3.0MM X 30MM; AND 3.5MM X 30MM
P890055|S002|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP WITH BOLUS SAFETY VALVE|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/1996|02/04/1997|||APPR|APPROVAL FOR (1) A CHANGE IN LABELING FOR THE MDOEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP WITH BOLUS SAFETY VALVE TO INCLUDE AN INDICATION FOR THE INTRASPINAL DELVIERY OF PRESERVATIVE-FREE MORPHINE SULFATE FOR THE TREATMENT OF PAIN OF MALIGNANT ORIGIN AND (2) THE INTRASPINAL CATHETER KIT.
P840008|S056|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER COMPACT S|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1996|11/05/1996|||APRL|DESIGN MODIFICATIONS:1)THE USE OF THE PERFORMA ULTRASOUND IMAGING SYSTEM 2)ADDITION OF X-RAY IMAGING AND 3)MINOR DESIGN CHANGES. THE DEVICE AS MODIFIED WILL E MARKETD UNDER THE TRADE NAME DORNIER COMPACT S LITHOTRIPTER AND IS INDICATED FOR THE FRAGMENTATION OF 5 TO 25 MILLIMETER KIDNEY STONES SUCH AS RENAL CALYX STONES AND RENAL PELVIC STONES
P890043|S031|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1996|11/18/1996|||APPR|APPROVAL FOR THE ATHEROCATH-BANTAM(TM) DCA SYSTEM
P900056|S019|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/03/1996|09/04/1996|||APPR|APPROVAL TO MARKET THE RAIL ROTAWIRE UNDER THE NAME EXTRASUPPORT ROTAWIRE
P890039|S015|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333|DXY|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/1995|07/09/1996|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION PROCEDURE
P940010|S001|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE(TM) FIBER OPTIC DIFFUSER|MVG|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/03/1996|08/07/1996|||APPR|APPROVAL FOR CHANGE IN LABELING CONSISTING OF ADDING AN ADDITIONAL WARNING STATEMENT CONCERNING POSSIBLE LEAKAGE OF BLOOD INTO DIFFUSER CAP
P880003|S060|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|THOR PTCA DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/1996|07/26/1996|||APPR|APPROVAL FOR A MODIFIED HUB BONDING PROCESS
P810046|S167|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/1996|01/08/1997|||APPR|APPROVAL FOR THE ACS CONCORDE(TM) CORONARY DILATATION CATHETER WITH QUARTER SIZE DIAMETERS IN THE 30 MM AND 40 MM BALLOON LENGTHS, A CHANGE IN THE PROXIMAL CATHETER MARKING MATERIAL AND CHANGES TOT HE MANUFACTURING PROCESS.
P910077|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ABBOTT IMX SA|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/1996|11/18/1996|||APPR|APPROVAL FOR MODEL 2840, SOFTWARE APPLICATION, VERSION 2.2 WHICH IS A MODIFICATION OF VERSION 2.1
P860019|S115|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/1996|09/30/1996|||APPR|APPROVAL FOR THE SCIMED RANGER WITH XTRA SILICONE COATING AND QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTCA) CATHETERS
P850079|S028|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, daily wear|HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES|LPL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/1996|08/01/1996|||APPR|APPROVAL FOR REFORMATTING THE PACKAGE INSERT, PROFESSIONAL FITTING AND INFORMATION GUIDE, AND PATIENT INSTRUCTIONS. THE MODIFIED LABELING DOES NOT RESULT IN CHANGES IN THE INDICATIONS FOR USE FOR THE DEVICES
P900061|S027|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE|LWS|CV|Normal 180 Day Track||N|07/15/1996|10/22/1996|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE TO 18 MONTHS FOR THE MODELS 7219 B/D/E, 7202 D/E JEWEL, 7220 B/C/D/E/ JEWEL PLUS AND 7221 B/C/CX/D/E/ MICROJEWEL(TM)
P900061|S028|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/15/1996|08/06/1996|||APPR|APPROVAL FOR THE MODEL 7221B/CX/D/E/ MICRO JEWEL WITH ENDOTAK SERIES LEADS INLCUDING 60, 70 AND 110 SERIES LEADS (MODELS 0060, 0062, 0063, 0064, 0070, 0072, 0073, 0074, 0075, 0113, 0115) AND THE MODEL 6836 Y CONNECTOR
P860019|S116|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/1996|06/11/1997|||APPR|APPROVAL FOR AN ALTERNATIVE PACKAGING CONFIGURATION.
N18033|S029|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)|LPM|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/1996|10/07/1996|||APPR|ADDITION OF A UV BLOCKER, NORBLOC(R) 7966, TO THE APPROVED MOLDED ETAFILCON A EXTENDED WEAR CONTACT LENS (CLEAR AND WITH VISIBILITY TINT), AND A MULTI-FOCAL DESIGN WHICH WAS REVIOUSLY CLEARED FOR THE DAILY WEAR ETAFILCON A LENS UNDER K953804
P910075|S008|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COMPLETE BRAND LUBRICATING AND REWETTING DROPS|LPN|OP|||N|07/11/1996|09/05/1996|||APPR|APPROVAL FOR A CHANGE IN THE STERILIZING FILTER (0.22 MICRON)
P850035|S020|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/1996|08/20/1996|||APPR|APPROVAL FOR THE SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR SHICH IS A MODIFICATION OF THE SPF-XL IMPLANTABLE SPINAL FUSION STIMULATOR. THE SPF-XL IMPLANTABLE SPINAL FUSION STIMULATOR CONSISTS OF 4 LEADS, EACH BEING 12 CM IN LENGTH WHILE THE SPF-XL II WILL HAVE ONLY 2 LEADS, EACH BEING 24 CM IN LENGTH. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR
P890039|S016|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||implantable pacemaker Pulse-generator|POLY-SAFE(TM) A-TRACK(TM) PACING LEADS|DXY|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/19/1996|11/09/1998|||APPR|Approval for the use of BioSpan(R) (MS/0.4 as a raw material for the polyurethane insulation for the above lead models.
P830056|S078|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1996|01/29/1998|||APPR|Approval for lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5.  These lenses are intended to be used for primary implantation for the visula correction of aphakia in patients 50 years of age or older where a cataractous lens has been removed using extracapsular extraction methods.  The lenses are intended to be placed in either the ciliary sulcus or capsular bag.
P790018|S028|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/1996|04/07/1997|||APPR|APPROVAL FOR A MODIFICATION TO THE STERILIZATION METHOD AND PACKAGING SYSTEM FOR THE DEVICE REFERENCED ABOVE
P910031|S010|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1996|12/02/1996|||APPR|APPROVAL FOR MODELS OF THE FACT(TM) AND ARC(TM) BALLOON CORONARY DILATATIN CATHETERS WITH AN ADD'L RADIOPAQUE MARKER
P880003|S061|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|THOR PTCA DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1996|01/17/1997|||APPR|APPROVAL FOR A MODIFIED INNER BODY MATERIAL, AN OPTIONAL GUIDEWIRE LUMEN COATING, AN OPTIONAL TIP LENGTH, OPTIONAL DUAL MARKER BANDS, AND A SIX-PLEAT BALLOON FOLDING PROCESS ON THE TITAN AND TITAN XL PTCA DILATATION CATHETERS.
P950014|S002|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|MOBILE PROSTATRON|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1996|10/16/1996|||APPR|APPROVAL FOR A MOBILE VERSION OF THE PROSTATRON
P940005|S001|ADVANCED TECHNOLOGY LABORATORIES, INC.|22100 BOTHELL EVERETT HWY.|P.O. BOX 3003|BOTHELL|WA|98041|3003|System, imaging, pulsed doppler, ultrasonic|HDI 3000 ULTRASOUND SYSTEM|IYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/1996|12/23/1996|||APPR|APPROVAL FOR A DESIGN CHANGE FROM THE ULTRAMARK(R) 9 ULTRASOUND SYSTEM WITH HIGH DEFINITION(TM) IMAGING (HDI(TM)) AND L10-5 SCANHEAD TO A HDI 3000(R) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD FOR THE INDICATION OF AN ADJUNCT TO MAMMOGRAPHY AND PHYSICAL BREAST EXAMINATION, TO PROVIDE A HIGH DEGREE OF PHYSICIAN CONFIDENCE IN DIFFERENTIATING BENIGN FROM MALIGNANT OR SUSPICIOUS BREAST LESIONS.
P950039|S002|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP(R) 2000 SYSTEM|MKQ|PA|Normal 180 Day Track|Other Report|N|07/30/1996|02/25/1997|N||APPR|APPROVAL FOR THE USE OF THE COMBINATION OF ENDOCERVICAL BRUSH AND PLASTIC SPATULA AS AN ALTERNATIVE TOT HE BROOM-TYPE SAMPLING DEVICE FOR THE THINPREP 2000 SYSTEM
P830034|S029|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-ONE(R) MULTI-PURPOSE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/1996|11/21/1996|N||APPR|APPROVAL FOR USE OF OPTI-ONE(R) MULTI-PURPOSE SOLUTION AS A DILUENT FOR OPTI-ZYME(R) ENZYMATIC CLEANER TABLETS
P820001|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-ZYME ENZYMATIC CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/1996|11/21/1996|||APPR|APPROVAL FOR THE USE OF OPTI-ONE(R) MULTI-PURPOSE SOLUTION AS A DILUENT FOR OPTI-ZYME(R) ENZYMATIC CLEANER TABLETS
P930012|S005|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|PAS CHAMPION HP PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1996|01/29/1997|||APPR|APPROVAL FOR THE PAS CHAMPION(TM) HP (HIGH PRESSURE) PTCA CATHETER WITH THE FOLLOWING BALLOON SIZES:3.0 MM, 3.5 MM, 4.0 MM DIAMETERS WITH 15 MM AND 20 MM LENGTHS. THIS DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P880086|S037|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L   PULSE GENERATORS MODELS 2360L AND 2364L|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1996|06/30/1997|||APPR|APPROVAL FOR THEMODEL 3250 APSU PROGRAMMER WITH MODEL 3263 SOFTWARE AND MODEL 3251 BASE STATION WITH MODEL 3265 SOFTWARE.
P880006|S025|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1996|06/30/1997|||APPR|APPROVAL FOR THE MODEL 3250 APSU PROGRAMMER WITH MODEL 3263 SOFTWARE AND MODEL 3251 BASE STATION WITH MODEL 3265 SOFTWARE.
P830045|S053|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFP PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/1996|06/30/1997|||APPR|APPROVAL FOR THE MODEL 3250 APSU PROGRAMMER WITH MODEL 3263 SOFTWARE AND MODEL 3251 BASE STATION WITH MODEL 3265 SOFTWARE.
P910023|S022|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/1996|11/08/1996|||APPR|APPROVAL FOR CADET HIGH-VOLTAGE CAN ICD MODELS V-105AC AND V-115AC, CADET TEST CAN MODEL AC-CDT-TCN, CADET TEST CABLE MODEL AC-CDT-TCB, CONTOUR HIGH-VOLTAGE CAN ICD MODELS V-135AC AND V-145AC, CONTOUR TEST CAN MODEL AC-TCN AND CONTOUR TEST CABLE MODEL AC-TCB
P820018|S070|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/1996|10/03/1996|||APPR|MODIFICATIONS TO THE LABELING TO INCLUDE INFORMATION REGARDING THE USE OF CELLULAR TELEPHONES WITH PATIENTS WEARING THESE DEVICES
P910020|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|MARATHON PACING SYSYTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1996|02/10/1997|||APPR|APPROVAL FOR MODIFICATIONS TO THE MARATHON DR AND SR PULSE GENERATORS, GRAPHICS PROGRAM MODULE MODEL 570-01, AND TO THE RELEASE 2.00 SOFTWARE FOR USE WITH THE RX5000 GRAPHICS PROGRAMMER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MARATHON Z PULSE GENERATOR MAODELS 294-09Z AND 292-09Z, MOMENTUM DR PULSE GENERATOR MODELS 294-23, 294-23Z, AND 292-23, GRAPHICS PROGRAM MODULE MODEL 570-01, AND RELEASE 2.02 SOFTWARE WITH USE WITH RX5000 GRAPHICS PROGRAMMER, AND IS INDICATED FOR LONG TERM CARDIAC PACING
P860019|S117|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/1996|01/17/1997|||APPR|APPROVAL FOR THE SCIMED(R) LONG SURPASS(TM) 30 PTCA PERFUSION CATHETER. THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTIONOF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING YOCARDIAL PERFUSION AND TO PROVIDE DISTAL BLOOD PERFUSION DURING BALLOON INFLATION.
P840024|S067|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/1996|09/10/1996|||APPR|APPLICANT REQUESTED APPROVAL TO USE A CERAMIC LID ON THE IC2406 CERAMIC PACKAGE INSTEAD OF THE KOVAR LID CURRENTLY USED
P890027|S036|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/1996|09/10/1996|||APPR|APPLICANT REQUESTED APPROVAL TO USE A CERAMIC LID ON THE IC2406 CERAMIC PACKAGE INSTEAD OF THE KOVAR LID CURRENTLY USED
P930014|S003|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P800049|S008|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|IRIDOCAPSULAR INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resteriliztion in the event of an "aborted cycle."
P810018|S036|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|UV ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P810001|S013|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P810032|S049|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|UV ABSORBING POST.CHAM.IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P820035|S015|ALCON|6201 South Freeway||Fort Worth|TX|76134|2099|intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P830040|S026|ALCONRESEARCH,LTD.|6201 SOUTH FREEWAY||FORT WORTH,|TX|76134||intraocular lens|3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alterante microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P840060|S026|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P880010|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbioloigcal monitoring system and one resterilization in the event of an "aborted cycle."
P880087|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/1996|09/04/1998|||APPR|Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P880038|S033|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|META(TM) III PULSE GENERATOR MODELS 1206, 1206E, 1206M|DXY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/09/1996|09/30/1996|||APPR|APPROVAL FOR AMODIFICATION TO THE LABELING REGARDING THE PROPER INSERTIO OF A LEAD INTO THE CONNECTOR PORT
P880086|S038|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/12/1996|05/13/1999|||APPR|Approval for the AddVent(R) VDDR Pacing System consisting of Models 2060BL and 2060LR pulse generators and the AV Plus(R) Model 1368 single-pass lead.  The indications are specified in Attachment A.
P880086|S039|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TRILOGY SR+ MODEL 2260L & 2264L CARDIAC PULSE GENERATORS WITH THE MODEL 3023 PDX FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/14/1996|03/12/1997|||APPR|APPROVAL FOR THE TRILOGY SR+ MODEL 2260L AND 2264L CARDIAC PULSE GENERATORS WITHT HE MODEL 3023 PD(X) FUNCTION PACK
P900043|S003|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/16/1996|12/20/1996|||APPR|APPROVAL FOR A SAPHENOUS VEIN GRAFT INDICATION AND OTHER MINOR MODIFICATIONS TO THE CURRENT LABEL.
P900033|S001|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||Dressing, wound and burn, interactive|INTEGRA (ARTIFICIAL SKIN)|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/1996|09/23/1996|||APPR|APPROVAL FOR SIZES 8"X10" AND 4"X5"
N18143|S033|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1996|02/10/1997|||APPR|APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOSE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES.
P830071|S007|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392|LPN|OP|Normal 180 Day Track||N|08/20/1996|02/10/1997|||APPR|APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOESE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES.
P830034|S030|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|ALCON MULTI-PURPOSE SOLUTION ID 81573|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1996|02/10/1997|||APPR|APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOSE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES.
P820001|S020|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1996|02/10/1997|||APPR|APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOESE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES) , AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE)BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE LDPE) BOTTLES.
N17908|S047|ALCON LABORATORIES|6201 SOUTH FREEWAY|PO BOX 6600|FORT WORTH|TX|76134|2099|Accessories, soft lens products|ALCON SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1996|02/10/1997|||APPR|APPROVAL TO REDUCE THE MINIMUM GAMMA RADIATION STERILIZATION DOESE SPECIFICATION FROM 25.0 KGY TO 16.2 KGY FOR THE MAJORITY OF PRIMARY PACKAGING COMPONENTS (BOTTLES, PLUGS AND CLOSURES), AND FROM 25.0 KGY TO 18.0 KGY FOR THE 8 OZ. HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AND THE 15 OZ. LOW DENSITY POLYETHYLENE (LDPE) BOTTLES.
P880003|S062|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|VALOR AND VALOR XL PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/1996|11/07/1996|||APPR|APPROVAL FOR QUARTER-SIZE BALLOONS ON THE VALOR AND VALOR XL PTCA DILATATION CATHETERS WHICH ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION O F A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPSOE OF IMPROVING MYOCARDIAL PERFUSION
P810046|S168|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ELIPSE 14,000.014 CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/1996|04/21/1997|||APPR|APPROVAL FOR THE USE OF A NEW ADHESIVE IN THE MANUFACTURING OF THE ACS RX ELIPSE(TM) .014 CORONARY DILATATION CATHETER
P900066|S002|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN TM PERFLUOROPROPANE (C3F8)GAS|LPO|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1996|09/24/1996|||APPR|APPROVAL TO ADD A 20 GRAM AND A 125 GRAM ALUMINUM LECTURE BOTTLE SIZE FOR THE REFERENCED DEVICES.
P900067|S002|AIR LIQUIDE|6141 EASTON ROAD|P.O. BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS|LPO|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1996|09/24/1996|||APPR|APPROVAL TO ADD A 20 GRAM AND A 125 GRAM ALUMINUM LECTURE BOTTLESIZE FOR THE REFERENCED DEVICES
P850088|S036|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|ULTRA CARE (TM) NEUTRALIZING TABLET|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1996|07/03/1997|||APPR|APPROVAL FOR AN ALTERNATE FORMULATION USING CATALASE RAW MATERIAL DERIVED FROM A NON-ANIMAL SOURCE AND AN ASSOCIATED CHANGE IN THE MINIMUM NEUTRALIZATION SOAK TIME FROM 2 TO 4 HOURS.  THE ALTERNATE FORMULATION INCLUDES NO CHANGES IN THE INDICATIONS FOR USE.
P930016|S003|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX EXCIMER LASER SYSTEM MODELS B AND C|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|08/26/1996|04/24/1997|97M-0084|04/17/1998|APPR|APPROVAL FOR THE VISX EXCIMER LASER SYSTEM (MODELS B & C).  THIS DEVICE IS INDICATED FOR MYOPIC ASTIGMATIC PHOTOREFRACTIVE KERATECTOMY (PRKA) USING AN ABLATION ZONE WITH A 6.0 MM MAJOR AXIS
P910031|S011|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/26/1996|04/09/1997|||APPR|APPROVAL FOR THE FOLLOWING:  1) A CHANGE IN THE BALLOON DESIGN FROM A DOUBLE LAYER OF POLYETHYLENE WITH A POLYETHYLENE TEREPHALATE CENTER REGION TO A SINGLE LAYER OF POLYETHYLENE TEREPHALATE; 2) A CHANGE IN CATHETER SHAFT MATERIAL FROM POLYETHYLENE TO NYLON; 3) A CHANGE IN THE INTERNAL SHAFT DESIGN FROM A TWO LUMEN SIDE BY SIDE DESIGN TO A TWO LUMEN COAXIAL DESIGN; 4) A CHANGE IN THE BALLOON/SHAFT BONDING METHOD FROM HEAT SEALING TO A URETHANE ADHESIVE; 5) A CHANGE IN THE BALLOON LENGTHS FROM 25 MM TO 22 MM AND FROM 20 MM TO 18 MM; AND 6)  A CHANGE IN THE COLOR OF THE CATHETER SHAFT FROM BLUE TO TEAL.
P910019|S002|INTENSIVE TECHNOLOGY, INC.|3574 RUFFIN RD.||SAN DIEGO|CA|92123||CATHETER, CORONARY, ATHERECTOMY|IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)|MCX|CV|Special (Immediate Track)|Other Report|N|08/27/1996|09/17/1996|||APPR|APPROVAL FOR MODIFICATIONS TO THE REAR SEAL ASSEMBLY OF THE TEC DRIVE COMPONENT OF THE TEC CORONARY ATHERECTOMY SYSTEM
P920051|S004|KARL STORZ ENDOSCOPY-AMERICA, INC.|1201 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|STORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION)|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/1996|01/10/1997|||APRL|APPROVAL OF A MOBILE VERSION OF THE MODULITH(R) SLX LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH(R) SLX MOBILE LITHOTRIPTER, AND IS INDICATED FOR USE IN THE NONINVASIVE GRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER.
N17755|S048|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|OSTEOBOND(TM) COPOLYMER BONE CEMENT|LOD|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/1996|10/28/1997|||APPR|Approval for a change in the gamma sterilization method of the Osteobond Copolymer Bone Cement powder component.
P820083|S021|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(R) SUTURE|GAW|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/1996|09/24/1996|||APPR|APPROVAL FOR COMBINING EPTFE PLEDGETS WITH GORE-TEX SUTURE AND APPROVAL FOR MODIFIED PACKAGING OF THE GORE-TEX SUTURE
P880003|S063|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|VALOR AND VALOR XL PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/03/1996|11/20/1996|||APPR|APPROVAL FOR VALOR AND VALOR XL PTCA DILATATION CATHETERS WITH 10MM AND 15MM BALLOON LENGTHS INDICATED FOR BALLOON DIALTATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION
P820083|S022|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX SUTURE WITH PLEDGETS|GAW|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/1996|09/24/1996|||APPR|APPROVAL FOR COMBINING EPTFE PLEDGETS WITH GORE-TEX SUTURE AND APPROVAL FOR MODIFIED PACKAGING OF THE GORE-TEX SUTURE
P910077|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/1996|05/06/1997|||APPR|APPROVAL FOR RHYTHMLINE(TM) TRANSTELEPHONIC INTERROGATION SYSTEM WHICH WILL PROVIDE REMOTE INTERROGATION AND DATA RETRIEVAL AND ECG MONITORING OF PATIENTS WITH VENTAK PRX II AND PRX III PULSE GENERATORS.
P930035|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/1996|12/11/1996|||APPR|APPROVAL FOR PECTORAL PLACEMENT OF THE VENTAK(R) P3 PULSE GENERATOR
P890048|S005|USCI, DIV. C.R. BARD, INC.|1200 TECHNOLOGY PARK DR.|P.O. BOX 7025|BILLERICA|MA|01821||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/1996|11/26/1996|||APPR|MODIFICATION TO THE PACKAGE TRAY OF THE USCI(R) PROBE(TM) III BALLOON-ON-A-WIRE(TM) DILATATION SYSTEM
P910075|S009|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COMPLETE BRAND LUBRICATING AND REWETTING DROPS|LPN|OP|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/1996|09/24/1996|||APPR|APPROVAL FOR USE OF A NEW METHOD TO ASSAY THE ACTIVE INGREDIENT, POLYHEXAMETHYLENE BIGUANIDE (PHMB)
P920023|S002|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT|UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS|MER|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/1996|09/27/1996|||APPR|APPROVAL TO INCREASE THE NUMBER OF INVESTIGATIONAL SITES FROM 7 TO 8 FOR THE "POST APPROVAL STUDY FOR THE UROLUME ENDOPROSTHESIS FOR TREATING RECURRENT BULBAR URETHRAL STRICTURE DISEASE
P890001|S018|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR SABLE(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/1996|06/11/1997|||APPR|APPROVAL FOR A NEW MODEL PTCA CATHETER, THE SABLE(TM) PTCA CATHETER.  THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION
N50510|S071|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/1996|12/20/1996|||APPR|APPROVAL FOR MEROPENEM TO BE INCLUDED ON THE GRAM NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 2, 4, AND 8UG/ML).
P830055|S048|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/1996|10/11/1996|||APPR|PACKAGING CHANGE FROM A BLISTER PACK WITH TYVEK LID TO A CHEVRON PEEL POUCH FOR TEXTURED AND POROUS PATELLA COMPONENTS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM
P900059|S004|MOLECULAR BIOSYSTEMS, INC.|10030 BARNES CANYON RD.||SAN DIEGO|CA|92121||Contrast media, ultrasound|ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED|MJS|RA|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/03/1996|06/17/1997|97M-0392|09/23/1997|APPR|APPROVAL FOR ALBUNEX(R).  THE DEVICE IS INDICATED FOR USE WITH TRANSVAGINAL ULTRASOUND TO ASSESS FALLOPIAN TUBE PATENCY.
P830055|S049|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/10/1996|10/10/1996|||APPR|MODIFICATION TO THE PEG DESIGN OF THE POROUS-COATED THREE-PEGGED PATELLA COMPONENT OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM
P830055|S050|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/1996|10/10/1996|||APPR|CORRECTIONS MADE TO THE PART NUMBERS FOR THE DEEP DISH ROTATING PLATFORM BRIDGING BEARING COMPONENTS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM
P900070|S014|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|TEMPO DR 2102 AND TEMP D 2902|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/16/1996|08/27/1997|||APPR|Approval for the Tempo DR Model 2102, Tempo D Model 2902, Tempo VR Model 1102, and Tempo V Model 1902 Pulse Generators.
P820083|S023|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(TM) SUTURE|GAW|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/1996|10/03/1996|||APPR|ADDITION OF TWO NEW INDICATIONS: FOR USE IN THE REPAIR OF DURA MATER AND FOR USE IN THE REPAIR OF REPLACEMENT OF CHORDAE TENDINEAE
P880003|S064|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|TITAN MEGA  AND TITAN MEGA XL|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/16/1996|02/10/1997|||APPR|APPROVAL FOR TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS. THESE CATHETERS ARE INDICATED FOR BALLOON DILATATION OF TH ESTENOTIC PORTION OF A COARONARY ARTERY OR BYAPSS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P820083|S024|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(TM) SUTURE|GAW|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/1996|10/03/1996|||APPR|APPROVAL FOR THE ADDITION OF TWO NEW INDICATIONS: FOR USE IN THE REPAIR OF DURA MATER AND FOR USE I THE REPAIR OFREPLACEMENT OF CHORDAE TENDINEAE
P870036|S040|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS|LOX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/1996|10/25/1996|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR THE MEDTRONIC(R) FALCON(R) FAMILY OF CORONARY BALLOON DILATATION CATHETERS
P860019|S118|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R)REBEL(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/1996|04/24/1997|||APPR|APPROVAL FOR A NEW SINGLE-OPERATOR EXCHANGE CATHETER WITH A SELF-CONTAINED CONTRAST DISPLACEMENT SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCIMED(R) REBEL(TM) PTCQA CATHETHER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PROTION OF A CORONARY ARTYER OR BYPASS GRAT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
N18331|S027|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE|PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED|NEW|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/1996|05/12/1997|||APPR|APPROVAL FOR THE USE OF PDS II (POLYDIOXANONE) SUTURE AS A COMPONENT OF THE ETHICON ENDOSUTURE SYSTEM AND FOR THE ADDITION OF ETHICON LTD., SCOTLAND, (ETHICON, LTD., P.O. BOX 408, BANKHEAD AVE., EDINBURGH, SCOTLAND AND ETHICON, LTD., KIRKTON CAMPUS, LIVINGSTON, WEST LOTHIAN, SCOTLAND) AS A MANUFACTURER OF PDS II SUTURE USED IN THE ETHICON ENDOSUTURE SYSTEM AND FOR THE ASSEMBLY OF THE SYSTEM COMPONENTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ETHICON ENDOSUTURE SYSTEM AND IS INDICATED FOR USE IN ALLTYPES OF SOFT TISSUE APPROXIMATION, INCLUDING USE IN PEDIATRIC CARDIOVASCULAR TISSUE WHERE GROWTH IS EXPECTED TO OCCUR AND OPHTHALMIC SURGERY.  PDS II SUTURE IS NOT INDICATED IN ADULT CARDIOVASCULAR TISSUE, MICROSURGERY AND NEURAL TISSUE.  THESE SUTURES ARE PARTICULARLY USEFUL WHERE THE COMBINATION OF AN ABSORBABLE SUTURE AND EXTENDED WOUND SUPPORT (UP TO SIX WEEKS) IS DESIRABLE.
P790020|S057|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/25/1996|11/21/1996|||APPR|CHANGES TO THE LABELING TO COMBINE THE PROFESSIONAL FITTING GUIDE, INSTRUCTIONS FOR WEARER BOOKLET, AND PACKAGE INSERT
P830055|S051|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/25/1996|10/11/1996|||APPR|MINOR DESIGN MODIFICATION TO THE POROUS COATED AND TEXTURED FEMORAL COMPONENTS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM
P900056|S020|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/1996|05/13/1997|||APPR|APPROVAL FOR AN ADDITIONAL CONTRACT STERILIZATION FACILITY, SOREX MEDICAL, SALT LAKE CITY, UTAH.
P950039|S003|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP(R) PROCESSOR|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/27/1996|04/08/1997|||APPR|APPROVAL FOR THE USE OF POLYETHYLENE TEREPHTHALATE (POLYESTER) AS AN ALTERNATIVE MEMBRANE MATERIAL FOR THE TRANSCYT FILTER FOR GYNECOLOGICAL SPECIMENS AND THEU SE OF THE POLYCARBONATE TRANSCYT FILTERS WITH  THE MODIFIED SOFTWARE ON THE THINPREP 2000 SYSTEM
P880081|S022|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/27/1996|03/24/1997|||APPR|APPROVAL FOR REVISING THE LABELING
P950014|S003|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Other Report|N|09/23/1996|12/27/1996|||APPR|APPROVAL FOR CHANGES TO THE PROSTATRON(TM) POSTAPPROVAL STUDY CASE REPORT FORM.
P910031|S012|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|ARC(TM) BALLOON CORONARY DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1996|02/27/1997|||APPR|APPROVAL FOR THE ADDITION OF THE 2.0 MM BALLON SIZE TO THE ARC(TM) BALLOON CORONARY DILATATION CATHETERS
P830039|S006|MEDICALCV, INC.|9725 SOUTH ROBERT TRAIL||INVER GROVE HEIGHTS|MN|55077||HEART-VALVE, MECHANICAL|OMNISCEINCE CARDIAC VALVE PROSTHESIS EXTENSION OF SHELF LIFE|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/1996|03/26/1997|||APPR|APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM THREE YEARS TO TEN YEARS AFTER THE INITIAL STERILIZATION OF THE OMNISCIENCE VALVE.
P890003|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SYNERGYST II,ELITE & LEGEND PULSE GENERATORS|DXY|CV|Normal 180 Day Track||N|10/01/1996|10/30/1996|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9892E SOFTWARE FOR USE WITH THE MODELS 9790 AND 9790C PROGRAMMERS
N16895|S084|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS (POLYMACON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/1996|01/30/1997|||APPR|APPROVAL FOR LABELING MODIFICTIONS TO SOFLENS(R) (POLYMACON) CONTACT LENSES INCLUDING THE FOLLOWING LENS TYPES (SERIES): 03, 04, OCCASIONS(TM) MULTIFOCAL, OPTIMA(TM) 38, OPTIMA(TM) 38/SP, U3, U4, SOFSPIN(TM), H03, H04, B3, B4, P.A.1, F3, H3, H4, N, NATURALTINE, OPTIMA(TM) FW, AND SEEQUENCE(TM). MODIFICATIONS INCLUDE: 1)REMOVING THE REPLACEMENT SYSTEM DESCRIPTORS FROM LABELING SPECIFIC TO THE OPTIMA(TM) FW CONTACT LENSES; 2)ADDING MONOVISIO FITTING TECHNIQUE FOR ALL BAUSCH & LOMB SOFLENS(R) (POLYMACON) CONTACT LENSES IN THIS SUPPLEMENT;3)CONSOLIDATING INFO IN SIX FITTING GUIDES INTO 3 FITTING GUIDES FOR SOFLENS(R), NATURALTINT(R), OCCASIONS(TM) MULTIFOCAL, AND P.A.1 CONTACT LENSES; 4)CONSOLIDATING 2 PATIENT INFO BOOKLETS (1 FOR FREQUENT REPLACEMENT USE AND 1 FOR DISPOSABLE USE) FOR SEEQUENCE(TM) (POLYMACON) VISIBILITY TINTED CONTACT LENSES INTO A SINGLE PATIENT INFO BOOKLET (THIS MODIFICATION RESULTS IN DELETION OF THE DISPOSABLE WEAR INDICATION); 5)FORMATTING CHANGES TO PACKAGE INSERTS, FITTING FUIDES & PATIENT INFO BOOKLETS TO BRING LABELING UP-TO-DATE WITH RECOMMENDATIONS IN CDRH'S CURRENT LABELING GUIDANCE; AND 6)SEPARATING THE THERAPEUTIC INDIATION FROM THE COSMETIC LABELING INCLUDED IN THIS SUPPLEMENT.
P950039|S004|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1996|10/08/1997|||APPR|Approval for use of PreservCyt Solution as an alternative collection and transport medium for gynecologic specimens tested with the Digene Hybrid Capture System HPV DNA Assay.
P930034|S006|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX APEX EXIMER LASER WORKSTATION|LZS|OP|||N|06/24/1996|10/22/1996|||APPR|APPROVAL FOR DISCONTINUING FURTHER FOLLOW-UP AND REPORT OF THE <6.0 MM SUBJECTS IN ACCORDANCE WITH THE POST APPROVAL REQUIREMENTS
P910023|S023|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/1996|04/17/1997|||APPR|APPROVAL FOR A NEW VERSION OF PROGRAMMER SOFTWARE FOR THE VENTRITEX(R) PROGRAMMER PR-1500.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRS V4.2H AND IS INDICATED FOR USE WITH PROGRAMMER PR-1500 AND CADENCE PULSE GENERATOR MODELS V-105, V-115 AND CONTOUR PULSE GENERATOR MODELS V-135, V-145.
P810046|S169|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACX RX COMET VP CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1996|02/04/1997|||APPR|APPROVAL FOR THE ACS RX COMET VP(TM) CORONARY DILATATION CATHETER. THIS DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PROTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR HTE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P920051|S005|KARL STORZ ENDOSCOPY-AMERICA, INC.|1201 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|STORZ MODULITH LITHOTRIPTER, MODEL SLX|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1996|12/27/1996|||APRL|APPROVAL FOR CHANGES TO THE X-RAY IMAGING SYSTEM OF THE STORZ MODULITH(R) LITHOTRIPTER, MODEL SLX.
P820031|S014|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/10/1996|03/10/1997|||APPR|APPROVAL FOR REDUCING THE FILL VOLUME FOR RENU(R) LENS REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME 7.5 ML BOTTLE.
P880013|S007|NELLCOR PURITAN BENNETT, INC.|2200 FARADAY AVE.||CARLSBAD|CA|92008|7208|VENTILATOR, HIGH FREQUENCY|HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/1996|06/24/1997|||APPR|APPROVAL FOR A MANUFACTURING SITE AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA.
P950022|S001|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|TVL(TM) LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1996|04/23/1997|N||APPR|APPROVAL FOR RV LEAD MODEL RV03, SVC LEAD MODELS SV04 AND SV05 WITH A SOLID SUTURE SLEEVE, STYLET MODELS S-70-4, S-70-F, S-45-X, S-55-X AND S-70-X AND FOR USE OF A LSER PROCESS TO REMOVE EXCESS SILICONE RUBBER FROM THE DEFIBRILLATION COILS.
P880072|S044|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|TC65B-SUV|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/1996|04/15/1997|||APPR|APPROVAL FOR MODEL TC65B-SUV AS A TIER A MODIFICATION OF PARENT MODEL PA17E-OUV.
P930031|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1996|04/15/1997|||APPR|APPROVAL FOR AN ALTERNATIVE DELIVERY SYSTEM WHICH ALLOWS THE USER TO PARTIALLY DEPLOY AND THEN RECONSTRAIN THE STENT TO FACILITATE PLACEMENT.
P830060|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1996|11/12/1996|||APPR|ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT WAS REVIEW UNDER THE PILOT PROGRAM DESCRIBED IN 4/20/96 DEAR CEO LTR - THIS APPROVAL APPLIES ONLY TO THE STERILIZATION SITE -
P890061|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P MODEL 1600|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1996|11/12/1996|||APPR|ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT REVIEWED UNDER THE SUPPLEMENT PILOT PROGRAM - THIS APPROVAL APPLIES ONLY TO THE NEW STERILIZATION SITE REQUEST
P910073|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1996|11/12/1996|||APPR|ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT REVIEWED UNDER THE PILOT PROGRAM AND THIS APPROVAL ONLY APPLIES TO THE REQUEST FOR A NEW STERILIZATION SITE
P910077|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1996|11/12/1996|||APPR|ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT WAS REVIEWED UNDER THE SUPPLEMENT PILOT PROGRAM - THIS APPROVAL APPLIES ONLY TO THE REQUEST FOR A NEW STERILIZATION SITE -
P930035|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1996|11/12/1996|||APPR|ALTERNATE STERILIZATION SITE LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT REVIEWED UNDER THE PILOT PROGRAM - THIS APPROVAL APPLIES ONLY TO THE REQUEST FOR A NEW STERILIZATION SITE
P940031|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR(TM) DR PACEMAKER SYSTEM||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1996|11/12/1996|||APPR|ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT WAS REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL APPLIES ONLY TO THE REQUEST FOR A NEW STERILIZATION FACILITY
P950001|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1996|11/12/1996|||APPR|ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL ONLY APPLIES TO THE REQUEST FOR A NEW STERILIZATION SITE
P840068|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR MODEL 2880 SOFTWARE APPLICATION|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1996|11/12/1996|||APPR|ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - (THIS PMA WAS REVIEWED UNDER THE PMA SUPPLEMENT PILOT PROGRAM THIS APPROVAL APPLIES ONLY TO THE NEW STERILIZATION SITE)
P870015|S025|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) LITHOTRIPTER|LNS|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/1996|11/18/1996|||APRL|USE OF THE PHYSICIAN'S REFERENCE GUIDE ENTITLED "PHYSICIAN'S REFERENCE GUIDE FOR THE MEDSTONE STS(R) SHOCK WAVE THERAPY SYSTEM"
P890034|S006|Covidien|6135 GUNBARREL AVE.||BOULDER|CO|80301||VENTILATOR, HIGH FREQUENCY|MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/1996|06/24/1997|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY AT NELLCOR PURITAN BENNETT, 2200 FARADAY AVE., CARLSBAD, CA.
P790005|S039|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1996|07/17/1997|||APPR|Approval for the Model ST-72 Implant Tester for use with the SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R)-2T, SpF(R)-4T, SpF(R)-XL, and the SpF(R)-XL II) and the OsteoGen(TM) Implantable Spinal Fusion Stimulator product line.
P850035|S021|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/1996|07/17/1997|||APPR|Approval for the Model ST-72 Implant Tester for use with the SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R) -2T, SpF(R)-4T, SpF(R)-XL, and the SpF(R)-XL II) and the OsteoGen(TM) Implantable Spinal Fusion Stimulator product line.
P940019|S002|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT(R) ILIAC ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1996|04/14/1997|||APPR|APPROVAL FOR AN ALTERNATE DELIVERY SYSTEM FOR THE WALLSTENT(TM) ILIAC ENDOPROSTHESIS (THE UNISTEP(TM) PLUS DELIVERY SYSTEM)
P890001|S019|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR PICO-ST|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1996|06/09/1997|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE PICO-ST(TM) PTCA CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PICO-ST(TM) II PTCA CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P870072|S003|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/1996|04/17/1997|||APPR|APPROVAL FOR ADDING AN ALTERNATE CONTRACT STERILIZER FACILITY, AND CHANGING THE MATERIAL AND CONFIGURATION OF THE STORAGE BOX FOR THE PUMPS AND CANNULAE
P940007|S002|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL/FOLDABLE IOL MODEL 127(920)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/1996|12/10/1996|||APPR|TRANSFER THE MANUFACTURING FACILITY FROM PHARMACIA IOVISION, INC., 34-B MAUCHLY ST., IRVINE, CA 92718.
P950018|S001|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)|LWL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/1996|12/11/1996|||APPR|APPROVAL FOR A MODIFICATION OF THE STABILITY PROTOCOL TO INCREASE THE ACCEPTANCE CRITERIA LIMIT FOR UV/VIS ABSORBANCE ON ACCELERATED AGIN (45 DEGREES C) SAMPLES FROM <0.2 TO <0.4 ABSORBANCE UNITS CM-1 AT 220NM
P890003|S048|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|PREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/1996|11/19/1996|||APPR|APPROVAL TO COMMERCIALLY DISTRIBUTE THE MEDTRONIC PREVA ST DR MODEL 7078 AND PREVA D MODEL 7068 PULSE GENERATORS; AND THE MODEL 9959 SOFTWARE
P950034|S001|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE|MCN|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/1996|11/07/1996|||APPR|CHANGE IN THE CURRENT HA/CMC SPECIFICATION FOR THE UREA ASSAY FROM THE CURRENT 3 - 15% TO A SPECIFICATION OF 10-18% FOR THE MODIFIED ASSAY. THE SUPPLEMENT ALSO REQUESTS THE REPLACEMENT OF THE USP RABBIT PYROGEN ASSAY WITH THE LIMULUS AMOEBOCYTE LYSATE (LAL) ASSAY AS THE STANDARD PYROGEN TEST
P920004|S004|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (TM)|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/1996|12/02/1996|||APPR|CHANGES TO THE INDICATIONS FOR USE TO INCLUDE USE OF VASOSEAL(R) FOLLOWING NON-CORONARY ANGIOGRAPHY AND NON-CORONARY BALLOON ANGIOPLASTY PROCEDURES
P940008|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RES-Q(TM) MICRON ICD SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/1996|02/28/1997|||APPR|APPROVAL FOR A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RES-Q(TM) MICRON MODEL 101-09 AND MDOEL 101-05
P930014|S004|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/1996|04/22/1997|||APPR|APPROVAL FOR LABELING CHANGES FOR THE ACRYSOF(R) MOLDED ACRYLIC IOLS.
P920047|S006|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|E P TECH EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/1996|03/12/1997|||APPR|APPROVAL FOR AN ALTERNATIVE HANDLE CONFIGURATION FOR THEIR EXISTING  CARDIAC ABLATION CATHETERS.
P830039|S007|MEDICALCV, INC.|9725 SOUTH ROBERT TRAIL||INVER GROVE HEIGHTS|MN|55077||HEART-VALVE, MECHANICAL|OMNICARBON CARDIAC VALVE PROSTHESIS|LWQ|CV|Panel Track|Change Design/Components/Specifications/Material|N|10/24/1996|07/26/2001|01M-0380|09/05/2001|APPR|APPROVAL FOR THE OMNICARBON(TM) CARDIAC VALVE PROSTHESIS, AORTIC MODEL 3313 IN SIZES 23, 25, 27, AND 29 MM, AND MITRAL SUPRA-ANNULAR MODEL 3523 IN SIES 27, 29, 31, AND 33 MM.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF DYSFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL HEART VALVES.
P950014|S004|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/25/1996|10/29/1996|||APPR|UPGRADES IN 1)THE LUXTRON THERMOMETRY UNIT FROM MODEL 3000-4 TO MODEL 3100; 2) THE COMPUTER PROCESSOR FROM 386 TO PENTIUM; AND 3) THE SOFTWARE FROM VERSION 3.07 TO VERSION 3.09
P840051|S008|DAVIS & GECK, INC.|1 CASPER ST.||DANBURY|CT|06810||SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID|MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE|GAM|SU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1996|11/15/1996|||APPR|APPROVAL OF A NEW SUPPLIER OF TRIMETHYLENE CARBONATE.
P950014|S005|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/1996|11/22/1996|||APPR|ADDITION OF A PRECAUTIONARY STATEMENT TO THE LABELING REGARDING THE STEPS THAT SHOULD BE TEKN IN THE EVENT OF PROSTAPROBE BALLOON DEFLATION DIFFICULTY
P840008|S057|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1996|04/29/1997|||APRL|ApproVAL FOR NON-ECG SHOCK WAVE TRIGGER MODES FOR THE ABOVE DEVICES
P890064|S005|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/1996|08/15/1997|||APPR|Approval for use of a cervical broom specimen collected and transported in the Cytyc Corporation PreservCyt(R) Solution for testing in the Digene Corporation Hybrid Capture(TM) System HPV DNA Assay.
P900070|S015|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|TEMPO DR 2102 AND TEMP D 2902|DXY|CV|Normal 180 Day Track|Other Report|N|11/06/1996|11/27/1996|||APPR|MODIFICATION TO THE LABELING REGARDING THE PROPER INSERTION OF A LEAD INTO THE CONNECTOR PORT
P880027|S042|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER CHUBBY(TM) PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/06/1996|02/04/1997|||APPR|ADDITIONAL BALLOON SIZES OF 4.5 AND 5.0 MM IN THE CHUBBY PTCA CATHETER LINE.
P880086|S040|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TRILOGY DC + PULSE GENERATOR, MODEL 2318L|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/1996|01/10/1997|||APPR|APPROVAL FOR THE TRILOGY DC+ MODEL 2318L PULSE GENERATOR WITH MODEL 3204A FUNCTION PACK FOR USE WITH THE APS II MODEL 30003 PROGRAMMER.
P860023|S012|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Accessories, soft lens products|BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1996|07/03/1997|||APPR|APPROVAL FOR A CHANGE IN THE FORMULATION AND CORRESPONDING MODIFICATIONS TO THE LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB RENU MULTIPLUS(TM) MULTI-PURPOSE SOLUTION AND IS INDICATED FOR USE IN THE DAILY CLEANING, PROMOTION OF DAILY PROTEIN REMOVAL, RINSING, CHEMICAL (NOT HEAT) DISINFECTION AND STORAGE OF SOFT (HYDROPHILIC) CONTACT LENSES AS RECOMMENDED BY THE EYE CARE PRACTITIONER.
P940022|S002|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342|||CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1996|01/10/1997|||APPR|APPROVAL FOR A MODIFICATION OF THE ELECTRODE COUPLING, REFERRED TO AS "ENHANCED BIPOLAR."
P820060|S010|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AXSYM AFP (LIST 7A48)|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1996|12/02/1996|||APPR|APPROVAL FOR MOVING THE NORMAL MOUSE SERUM CONTAINED IN THE CONJUGATE COMPONENT TO THE ASSAY DILUENT COMPONENT
N17004|S008|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1996|12/18/1996|||APPR|APPROVAL FOR MINOR CHANGES TO PACKAGING AND LABELING OF THE PRODUCT.
P950034|S002|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE|MCN|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/1996|12/17/1996|||APPR|NEW MANUFACTURING SITE LOCATED AT GENZYME FINE CHEMICAL, QUALITY CONTROL LABORATORY, ENGLAND
P900061|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/1996|03/07/1997|||APPR|APPROVAL FOR JEWEL(R) MODELS 7219 B/D/E, 7202 D/E, 7220 B/D/E, 7221 B/CX/D/E MICROJEWEL(TM), AND 7223 MICRO JEWEL II(TM) WITH ENDOTAK(R) DSP LEAD MODELS 0092, 0093, 0094, 0096, 0097, 0123, AND 0125 AND THE MODEL 6836 Y CONNECTOR.
P840066|S034|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/1996|01/23/1997|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE REFERENCED DEVICE TO BE LOCATED AT ALLERGAN OPTICAL, 8301 MARS DRIVE, WACO, TX  76712
P850089|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/20/1996|02/04/1997|||APPR|APPROVAL FOR DISTRIBUTION BY VIATRON, INC. OF THE MODELS CAPSURE(R) Z, 5033, 5934, 5534 AND CAPSUREFIX(R) 4068 UNDER A NEW TRADE NAME. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAMES VITATRON(R) IMPULSE(TM) IMG 49, IMPULSE(TM) IMG 49B, IMPULSE(TM) IMG 49JB, AND PIROUET(TM)+IMU 49B. AND ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE.
P940031|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR(TM) DR PACEMAKER SYSTEM||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/1996|01/14/1997|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085. THIS SUPPLEMENT QUALIFIED FOR REVIEW UNDER THE PMA SUPPLEMENT PILOT DESCRIBED IN THE MARCH 20, 1996 "DEAR PRESIDENT OR CEO" LETTER REGARDING CHANGES IN MANUFACTURING SITES.
N50510|S072|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/20/1996|02/19/1997|||APPR|APPROVAL FOR CEFEPIME TO BE INLCUDED ON THE GRAM NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 4, 8 AND 16UG/ML)
P910067|S002|SUMMIT TECHNOLOGY, INC.|21 HICKORY DR.||WALTHAM|MA|02154||Excimer laser system|SVS APEX PLUS EXCIMER LASER WORKSTATION|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/20/1996|03/12/1997|||APPR|APPROVAL FOR A NEW LASER CALIBRATION MEDIUM AND PROCEDURE.
P930034|S007|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX APEX EXIMER LASER WORKSTATION|LZS|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/1996|03/12/1997|||APPR|APPROVAL FOR A NEW LASER CALIBRATION MEDIUM AND PROCEDURE.
P870036|S041|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/1996|03/07/1997|||APPR|APPROVAL FOR A MODIFIED BONDING PROCESS FOR THE RADIOPAQUE MARKER BANDS
P930039|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSUREFIX(R) MODEL 4068 PACING LEAD|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/1996|02/04/1997|||APPR|APPROVAL FOR DISTRIBUTION BY VIATRON, INC. OF THE MODELS CAPSURE(R) Z, 5033, 5034, 5534 AND CAPSUREFIX(R) 4068 UNDER A NEW TRADE NAME.  THE DEVICES WILL BE MARKETED UNDER THE TRADE NAMES VITATRON(R) IMPULSE(TM) IMG 49, IMPULSE(TM) IMG 49B, IMPULSE(TM) IMG 49JB, AND PIROUET(TM)+IMU 49B. AND ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE.
P950039|S005|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP(R) PROCESSOR|MKQ|PA|||N|10/15/1996|11/06/1996|||APPR|NEW LABELING INCLUDING STATISTICAL ANALYSIS OF THE DATA
P810037|S007|KONTRON CARDIOVASCULAR|9 PLYMOUTH ST.||EVERETT|MA|02149||MONITOR, CARBON-DIOXIDE, CUTANEOUS|KONTRON CUTANEOUS PCO2 MONITOR|LKD|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/1996|11/25/1997|||APPR|Approval for modification of MicroGas 7640 with COMBI 81.  The device, as modified, will be marketed under the trade name MicroGas 7650 with COMBI M82.
P850077|S022|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, daily wear|SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN|LPL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/1996|03/10/1997|||APPR|APPROVAL FOR AN ALTERNATE MOLDED LENS MANUFACTURING PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND ARE INDICATED AS FOLLOWS:  1)MULTIPLES TORIC LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSON WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROPIC AND AHVE REFRACTIVE ASTIGMATISM NOT EXCEEDING 7.00 DIOPTERS (D).  2)  MULTIPLES SPHERICAL LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROPIC.  THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1.50 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENSES RANGE IN POWER FROM -20.00 D TO +10.00 D.  3)  MULTIPLES APHAKIC LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC PERSONS WITH NONDISEASED EYES THAT ARE HYPEROPIC.  THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1.50 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENSES RANGE IN POWER FROM +10.50 D TO +20.00 D.
P860019|S119|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1996|06/09/1997|||APPR|APPROVAL FOR THE NC RANGER PTCA CATHETER.
P950034|S003|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE|MCN|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/22/1996|12/16/1996|||APPR|APPROVAL TO EXTEND THE APPROVED 12-MONTH EXPIRATORY PERIOD TO 18 MONTHS.
P910023|S024|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1996|05/22/1997|||APPR|APPROVAL TO USE THE PATIENT MANUAL, "PEACE OF MIND."
P810046|S170|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS CORONARY DILATATION CATHETERS (INDICATION)|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|11/25/1996|05/13/1997|||APPR|APPROVAL FOR: A) THE ADDITION OF THE INDICATION "BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION OFR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION"; AND (B) OTHER MODIFICATIONS OT THE CURRENT LABEL TO REFLECT THIS NEW INDICATION.
P910030|S005|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||STENT, CORONARY|GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/26/1996|05/12/1997|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE ORIGINAL GIANTURCO-ROUBIN CORONARY FLEX STENT(TM).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GR II(TM) CORONARY STENT AND IS INDICATED FOR TREATMENT OF ACUTE OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.1 MM TO 4.0 MM.
P960019|S001|LASER VISION CENTERS, INC.|540 MARYVILLE CENTRE DR., #200||ST. LOUIS|MO|63141||Excimer laser system|MOBILEXCIMER FOR PTK AND PRK|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/1996|04/07/1997|||APPR|APPROVAL FOR THE LASERVISION(R)/VISX EXCIMER LASER SYSTEM MODEL C FOR PTK AND PRK TO BE INSTALLED IN THE CALUMET COACH MODEL MMT-436V SEMI-TRAILER COACH, WHICH WILL BE MANUFACTURED BY THE CALUMET COACH COMPANY, 2150 E.DALTON RD., CALUMET CITY, IL  60409-1411.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MOBILEXCIMER(R) FOR PHOTOTHERAPEUTIC KERATECTOMY (PTK) AND PHOTOREFRACTIVE KERATECTOMY (PRK) THE DEVICE INDICATIONS REMAINED THE SAME
P870076|S005|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM|KNH|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/1996|12/12/1996|||APPR|NEW MANUFACTURING SITE LOCATED AT CIRCON-CABOT MEDICAL, RACINE, WISCONSIN.
P910001|S012|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/1996|09/24/1997|||APPR|Approval for the 2.0 mm Vitesse(TM)-EII (Eccentric Monorail) Catheter, Model 120-008.
P880003|S065|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|PTCA DILATATION CATHETERS FOR VALOR AND VALOR XL PTCA|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/1996|04/30/1997|||APPR|
P890001|S020|LEOCOR, INC.|1301 REGENTS PK. DR.||HOUSTON|TX|77058||Catheters, transluminal coronary angioplasty, percutaneous|LEOCOR SABLE(TM) PTCA CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/1996|01/16/1997|||APPR|MODIFIED DEVICE PACKAGING FOR ALL LEOCOR'S CURRENTLY MARKETED PTCA CATHETERS.
P840064|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT VISCOELASTIC SOLUTION|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/1996|03/17/1998|||APPR|APPROVAL FOR THE INCORPORATION OF VISCOAT AND PROVISC, WHICH MAKE UP THE DUOVISC PRODUCT, INTO A SINGLE PLASTIC TRAY, TO BE STERILIZED AND PROCESSED AT ALCON'S PUERTO RICO FACILITY; AND A CHANGE IN THE STERILIZATION PROCESS AT ALCON'S PUERTO RICO FACILITY FOR THE DUOVISC SYSTEM.
P890047|S011|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC VISCOELASTIC MATERIAL|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/1996|03/17/1998|||APPR|Approval for the incorporation of VISCOAT and PROVISC, which make up the DUOVISC product, into a single plastic tray, to be sterilized and processed at Alcon's Puerto Rico; and a change in the sterilization process at Alcon's Puerto Rico facility for the DUOVISC System.
P880087|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/1996|04/22/1997|||APPR|APPROVAL FOR LABELING CHANGES FOR THE MODELS MT, MTU, MTA, AND MTAU IOLS
P900023|S020|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/1996|12/31/1996|||APPR|APPROVAL FOR CHANGING THE TUBING DIAMETER OF THE TUBES LEADING TO/FROM THE LEFT SIDE FLOW TRANSDUCER FROM 1/4 INCH TO 1/16 INCH ID (INNDER DIAMETER) AND CHANGING THE CONSOLE COOLING FAN FROM ONE HAVING A CAPACITY OF 94 CFM (CUBIC FEET PER MINUTE) TO ONE HAVING A CAPACITY OF 55 CFM.
P840060|S027|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|IOL MODELS MZ60PD AND MZ60MD|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1996|06/06/1997|||APPR|APPROVAL FOR MODELS MZ60PD AND MZ60MD POSTERIOR CHAMBER IOLS.
P840024|S068|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1996|04/04/1997|||APPR|APPROVAL FOR MARKETING OF THE AUDALLION BEAM FORMING PRE-PROCESSOR AND FOR APPROVAL OF DEVICE EFFECTIVENESS CLAIMS FOR THE AUDALLIN AS USED WIT THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (SPEAK SPEECH PROCESSOR).  THE AUDALLION IS INDICATED FOR USE BY ADULTS WHO ARE USING THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM TO AID THEM IN IMPROVING SPEECH UNDERSTADNING IN NOISY ENVIRONMENTS WHEN THE SPEECH AND THE NOISE ARE NOT COMING FROM THE SAME DIRECTION
P840008|S058|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1996|05/05/1997|||APRL|APPROVAL FOR A NON-ECG SHOCK WAVE TRIGGER MODE FOR THE DORNIER COMPACT S AND THE MOVE AND SHOOT FEATURE FOR THE DORNIER LITHOTRIPTER (STATIONARY AND TRANSPORTABLE).
P880003|S066|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|THOR PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/1996|04/30/1997|||APPR|APPROVAL FOR THOR(TM) PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS
P820034|S005|REPRO-MED SYSTEMS, INC.|24 CARPENTER RD.||CHESTER|NY|10918||DEVICE, TESTICULAR HYPOTHERMIA|REPRO-MED - THD|LOA|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/1996|01/14/1997|||APPR|APPROVAL TO MOVE THE MANUFACTURING SITE LOCATED AT REPRO-MED SYSTEMS, MIDDLETOWN, NY TO REPRO-MED SYSTEMS, 24 CARPENTER RD., CHESTER, NY.  THIS SUPPLEMENT QUALIFIED FOR REVIEW UNDER THE PMA SUPPLEMENT PILOT DESCRIBED IN THE 20-MAR-96 "DEAR PRESIDENT OR CEO" LETTER RE: CHANGES IN MANUFACTURING SITES.
P880072|S045|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|TC65B-SUV|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/1996|03/13/1997|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT TRI-STATE, HOSPITAL SUPPLY CORP., 3310 S. MAIN ST., SALISBURY, N.C.  28147
P880062|S002|LABTHERMICS TECHNOLOGIES, INC.|701 DEVONSHIRE DR., BLDG. B-1||CHAMPAIGN|IL|61820||Applicator, hyperthermia, deep heating, ultrasound|SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM|LNB|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1996|02/13/1997|||APPR|APPROVAL FOR CHANGES TO THE COMPUTER SYSTEM AND REVISIONS TO THE OPERATOR'S MANUAL FOR THE SONOTHERM 1000.
P940035|S001|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074|||MATRITECH NMP22(TM) TEST KIT||IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1996|03/19/1997|||APPR|APPROVAL FOR THE CHANGE IN SPECIMEN COLLECTION TO A SINGLE VOID OF URINE, COLLECTED BETWEEN MIDNIGHT AND NOON, WHICH WILL BE TESTED USING THE MATRITECH NMP22(R) TEST KIT.
P840008|S059|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER COMPACT S MOBILE|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/1996|12/20/1996|||APRL|APPROVAL OF A MOBILE VERSION OF THE COMPACT S LITHOTRIPTER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DORNIER COMPACT S MOBILE AND IS INDICATED FOR THE FRAGMENTATION OF 5 TO 25 MILLIMETER KIDNEY STONES SUCH AS RENAL CALYX STONES AND RENAL PELVICE STONES.
P840008|S060|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER COMPACT S TRANSPORTABLE|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/1996|12/20/1996|||APRL|APPROVAL OF A TRANSPORTABLE VERSION OF THE COMPACT S LITHOTRIPTER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DORNIER COMPACT S TRANSPORTABLE AND IS INDICATED FOR THE FRAGMENTATION OF 5 TO 25 MILLIMETER KIDNEY STONES SUCH AS RENAL CALYX STONES AND RENAL PELVIC STONES.
P790017|S060|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R)TELESCOPE(TM) SINGLE OPERATOR BALLOON|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/1996|12/15/1997|||APPR|Approval for a new PTCA catheter line.  The device, as modified, will be marketed under the trade name USCI(R) Telescope(TM) Single Operator Overl-the-Wire Balloon Catheter with Rely(TM) Balloon Material and Hydro/Pel(R) Coating and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P820001|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-ZYME ENZYMATIC CLEANER|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/1996|05/15/1997|||APPR|APPROVAL FOR (1) USE OF OPTI-SOAK(R) CONDITIONING SOLUTION AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER, (2) TO EXPAND THE INDICATIONS FOR USE OF OPTI-FREE(R) SUPRACLENS(TM) TO ALLOW FOR USE WITH RIGID GAS PERMEABLE (RGP) CONTACT LENSES, AND (3) FOR USE OF OPTI-CLEAN(R) II DAILY CLEANER AS AN ALTERNATE DAILY CLEANER IN THE OPTI-SOAK(R) LENS CARE REGIMEN.
P830071|S008|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/1996|05/15/1997|||APPR|APPROVAL FOR (1) USE OF OPTI-SOAK(R) CONDITIONING SOLUTION AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER, (2) TO EXPAND THE INDICATIONS FOR USE OF OPTI-FREE(R) SUPRACLENS(TM) TO ALLOW FOR USE WITH RIGID GAS PERMEABLE (RGP) CONTACT LENSES, AND (3) FOR USE OF OPTI-CLEAN(R) II DAILY CLEANER AS AN ALTERANTE DAILY CLEANER IN THE OPTI-SOAK(R) LENS CARE REGIMEN.
P830037|S040|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES|LPM|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/1996|05/15/1997|||APPR|APPROVAL TO ADD AN ULTRA VIOLET ABSORBER TO THE CLEAR AND LITETINE LATHE CUT POLYMER RODS FOR THE SUBJECT DEVICES.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES DURASOFT(R)3 AND DURASOFT(R)3 UV (PHEMFILCON A) SPHERICAL AND OPTIFIT(R) TORIC CLEAR, LITETINT, COLORS, AND COLOR COMPLEMENTS SOFT (HYDROPHILIC) CONTACT LENSES (LATHE CUT) FOR EXTENDED WEAR WITH NO CHANGE IN THE CURRENTLY APPROVED INDICATIONS FOR USE.
P930016|S004|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX EXCIMER LASER SYSTEM MODELS B AND C|LZS|OP|Normal 180 Day Track|Other Report|N|12/17/1996|06/12/1997|||APPR|APPROVAL FOR REVISED PROTOCOL FOR POST-APPROVAL STUDY TO DETECT AND REPORT RARE BUT SERIOUS ADVERSE EVENT.  *PLEASE NOTE THAT LONG-TERM DATA MUST BE REFLECTED IN THE LABELING (VIA A SUPPLEMENT TO THE PMA) WHEN THE ADDITIONAL FOLLOW-UPS AND/OR POST-APPROVAL STUDIES ARE COMPLETED.
P920004|S005|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (TM)|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/1996|01/07/1997|||APPR|APPROVAL FOR INCLUDING THE VASOSEAL(R) PATIENT INFORMATION GUIDE IN THE SHIPPING CONTAINER FOR THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE.
P890048|S006|USCI, DIV. C.R. BARD, INC.|1200 TECHNOLOGY PARK DR.|P.O. BOX 7025|BILLERICA|MA|01821||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/1996|02/04/1997|||APPR|MODIFIED LABELING FOR USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) DILATATION SYSTEM.
P830034|S031|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE REWETTING DROPS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|03/26/1997|||APPR|APPROVAL FOR REDUCING THE FILL VOLUME OF OPTI-FREE(R) REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME OPAQUE LOW DENSITY POLYETHYLENE (LDPE) BOTTLE.
P900061|S030|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|03/06/1997|||APPR|APPROVAL FOR USE OF THE WILSON GREATBACH LIMITED MODEL 9517 BATTERY AS AN ALTERNATE POWER SOURCE FOR THE MODEL 7221 MICRO JEWEL(R)
P810046|S171|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX COMET CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|05/12/1997|||APPR|APPROVAL FOR THE ACS RX COMET(TM) CORONARY DILATATION CATHETER WITH THE 40 MM BALLOON LENGTHS WITH THE HALF SIZES (I.E., 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, 4.0 MM), THE 15 MM BALLOON LENGTHS WITH THE QUARTER SIZES (I.E., 2.75 MM, 3.25 MM AND 3.75 MM DIAMETERS), THE 30 MM BALLOON LENGTHS (I.E., 2.75 MM, 3.25 MM, 3.75 MM AND 4.0 MM DIAMETERS) AND A SINGLE 20 MM BALLOON LENGTH (I.E., 1.5 MM) AND MODIFICATION OF THE BALLOON COMPLIANCE CHART OF THE ACS RX COMET(TM) CORONARY DILATATION CATHETER TO INLCUDE DATA UP TO 18 ATM FOR BALLOONS WITH A RATED BURST PRESSURE (RBP) OF 14 ATM TO BE CONSISTENT WITH OTHER PTCA MANUFACTURERS.
P940029|S003|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|PAPNET (R) TESTING SYSTEM|MNM|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|06/25/1997|||APPR|APPROVAL FOR SPECIFIC COMPUTER HARDWARE AND SOFTWARE CHANGES FOR THE REVIEW STATION COMPONENT OF THE PAPNET TESTING SYSTEM.
P960012|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||Accessories, soft lens products|REFRESH CL(TM)/LUBRICATING AND REWETING DROPS|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/23/1996|04/24/1997|||APPR|APPROVAL TO ADD RIGID GAS PERMEABLE CONTACT LENSES TO THE LABEL INDICATIONS.
N50510|S073|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/23/1996|02/19/1997|||APPR|APPROVAL FOR CEFPODOXIME TO BE INCLUDED ON THE GRAM NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATION (EQUIVALENT TO 1, 2 AND 4 UG/ML)
P810046|S172|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS TX2000 VP CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|04/07/1997|||APPR|APPROVAL FOR THE ACS TX2000 VP(TM) CORONARY DILATATION CATHETER.  THIS CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION
P940019|S003|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT(R) ILIAC ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|06/16/1997|||APPR|APPROVAL FOR AN ALTERNATE STENT MATERIAL.
P910016|S008|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE|MBD|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/1996|01/29/1997|||APPR|APPROVAL FOR SIX SIZE OPTIONS, TWO FIXATION PEGS ON THE FEMORAL COMPONENT, A 7 DEGREE DISTAL BONE CUT SURFACE ON THE FEMORAL COMPONENT, AND A SINGLE MENISCAL BEARING TRACK ACROSS ALL SIZES OF THE TIBIAL COMPONENT FOR THE SECOND GENERATION OF TH E NEW JERSEY LCS TOTAL KNEE SYSTEM UNICOMPARTMENTAL DEVICE CONFIGURATION.
P950002|S001|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK INTERBODY FUSION SYSTEM|MAX|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/1996|07/22/1997|||APPR|APPROVAL TO INCLUDE THE LAPAROSCOPIC SURGICAL APPROACH IN THE LABELING FOR THE BAK INTERBODY FUSION SYSTEM.
P930029|S008|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/1996|07/29/1997|||APPR|APPROVAL FOR THE 5 FRENCH RF MARINR CATHETER.
P890057|S008|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/1997|05/02/1997|||APPR|APPROVAL FOR A GAS PRESSURE REGULATOR ADJUSTOR SCREW CHANGE.
P880027|S043|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|ASUKA(TM) AND ASUKA(TM) LONGY PTCA CATHETERS|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/1997|02/19/1997|||APPR|INCREASE IN RATED BURST PRESSURE FOR THE SCHNEIDER ASUKA(TM) AND ASUKA(TM) LONGY PTCA CATHETERS
P880027|S044|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|GOLDIE TM AND GOLDIE TM LONGY PTCA CATHETERS|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/1997|02/19/1997|||APPR|INCREASE IN RATED BURST PRESSURE FOR THE GOLDIE(TM) AND GOLDIE(TM) LONGY PTCA CATHETERS.
N50510|S074|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/1997|03/17/1997|||APPR|APPROVAL FOR LEVOFLOXACIN TO BE INCLUDED ON THE GRAM POSITIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 2, 4 AND 8UG/ML).
P910023|S025|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/1997|03/03/1997|||APPR|APPROVAL FOR USE OF PROGRAMMER SOFTWARE VERSION 4.1.5G
P810046|S173|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|TX-2000|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/16/1997|04/21/1997|||APPR|APPROVAL FOR THE ACS TX2000(TM) CORONARY DILATATION CATHETER WITH NEW BALLOON LENGTHS (15 MM AND 40 MM), ADDITIONAL BALLOON DIAMETERS FOR THE 20 MM AND 30 MM BALLOON LENGTHS, AND REVISED LABELING.
P900043|S005|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/1997|03/13/1997|||APPR|APPROVAL FOR CHANGES IN THE BALLOON FOLDING AND STENT CRIMPING MANUFACTURING PROCESS AND THE ADDITION OF A NEW STENT RETENTION TEST
P820053|S025|ADVANCED MEDICAL OPTICS, INC.|2525 DUPONT DR.||IRVINE|CA|92612||Accessories, soft lens products|COMFORTCARE GP(R) WETTING AND SOAKING SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/1997|02/13/1997|N||APPR|APPROVAL FOR ALLERGAN, 8301 MARS DR., WACO, TX 76712 AS AN ALTERNATE MANUFACTURING SITE
P840068|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/17/1997|03/25/1997|||APPR|APPROVAL FOR THE VIGOR MODEL 2880 SOFTWARE APPLICATION VERSION 3.0, TO BE USED WITH MODEL 2950 OR MODEL 2901 PROGRAMMER/RECORDER/MONITOR DEVICES.
P940031|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR MODEL 2880 SOFTWARE APPLICATION (REV 3.0)||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/17/1997|03/25/1997|||APPR|APPROVAL FOR THE VIGOR MODEL 2880 SOFTWARE APPLICATION VERSION 3.0, TO BE USED WITH MODEL 2950 OR MODEL 2901 PROGRAMMER/RECORDER/MONITOR DEVICES.
P840002|S009|CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|STAT-PACE II ESOPHAGEAL PACING SYSTEM|LPA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/1997|09/03/1997|||APPR|Approval for design and labeling modification to the Tapsystem 2A and the STAT-PACE II Esophageal Pacing Systems.
P850062|S002|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|HEPATITIS DELTA SEROLOGICAL REAGENTS|ABBOTT ANTI-DELTA EIA|LQI|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/1997|02/26/1997|||APPR|CHANGE IN THE SPECIFICATIONS FOR THE CONJUGATE CONCENTRATE FROM A NEGATIVE CONTROL SAMPLE WITH A STANDARD RATION OF 0.90- 1.10, TO A NEGATIVE CONTROL MEAN O.D. OF 1.17 - 1.43
P790017|S061|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI(R)PROCROSS(TM) OVER THE WIRE BALLON DILATATION CATHETERT WITH RELY TM BALLOON MATERIAL AND HYDRO/PEL|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/1997|03/03/1997|||APPR|APPROVAL FOR ADDITIONAL QUARTER MILLIMETER DIAMETER SIZE MODELS OF THE PROCROSS(TM) CATHETER LINE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME USCI(R) PROCROSS(TM) OVER-THE-WIRE DILATATION CATHETER WITH RELY(TM) BALLOON MATERIAL AND HYDRO/PEL(R) COATING AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P960004|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|THINLINE   ENDOCARDIAL PACING LEADS|DXY|CV|Normal 180 Day Track||N|01/27/1997|08/29/1997|||APPR|Approval for the ThinLine(TM) EZ Model 438-10 Endocardial Pacing Lead.  This device is indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator.
P930038|S001|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/1997|09/17/1997|||APPR|Approval for revising the device labeling to include an indication for early ambulation in diagnostic angiography patients.
P870036|S042|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL|LOX|CV|||N|01/29/1997|07/28/1997|||APPR|APPROVAL FOR THE ADDITION OF AN ACCESSORY DEVICE, THE FOLIO BALLOON SHAPING TOOL, TO YOUR CURRENTLY MARKETED LINE OF MEDTRONIC (R) MILLENIA(TM) CORONARY BALLOON DILATATION CATHETERS.
P840068|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|02/18/1997|||APPR|APPROVAL FOR THE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS.
P910077|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|02/18/1997|||APPR|APPROVAL FOR THE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS.
P940031|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR(R) DR/SR PACEMAKER SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1996|02/18/1997|||APPR|APPROVAL FORT HE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MDOEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS.
P860003|S028|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHORESIS SYSTEM|LNR|GU|||N|01/30/1997|03/25/1997|||APPR|APPROVAL FOR THE USE OF EXTERNAL BIOLOGICAL INDICATORS TO MONITOR THE STERILIZATIN CYCLES FOR THE PHOTOPHERESIS TPS101 BLOOD TUBING SET, TPS102 PHOTOCEPTOR(R), AND A COMMERCIALLY AVAILABLE BLOOD CENTRIFUGE BOWL.
P950040|S001|PERSONAL HEALTH & HYGIENE, INC.|2 NORTH CHARLES STREE||BALTIMORE|MD|21201||ENZYME IMMUNOASSAY, CANNABINOIDS|DR. BROWN'S HOME DRUG TESTING KIT|LDJ|TX|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/1997|02/26/1997|||APPR|APPROVAL FOR A VOLUNTARY PLEDGE AND CONSENT FORM AS PART OF THE LABELING
P940034|S004|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|MWA|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/1997|05/15/1998|||APPR|Approval for:1)reagent manufacturing modifications that include reformulation of the specimen dilution buffer and enzyme dilution buffer reagents; packaging of the amplification reagent in one vial, a modified lyophilization cycle for the hybridization reagent, and an increased volume of reconstituion buffer provided; 2) kit configuration changes that include deletion of the termination reagent and hybridization controls; and 3)assay protocol changes that include use of increased sample size, decreased volume of specimen dilution buffer, reduced amplification time, increased selection time, and elimination of the termination step.  The MTD Test is indicated for the direct detection of Mycobacterium tuberculosis complex rRNA in evaluating AFB smear positive sediments prepared using NALC-NaOH digestion-decontamination of respiratory specimens from untreated patients suspected of having tuberculosis.  Patients who have received no anti-tuberculous therapy, less than 7 days of such therapy, or have not received such therapy in the last 12 months may be evaluated with this test.  The MTD test should be performed only in laboratories proficient in the culture and identification of M.tuberculosis (Level II and III, or extent 3 and 4 laboratories).  The MTD should always be performed in conjuction with mycobacterial culture.
P950040|S002|PERSONAL HEALTH & HYGIENE, INC.|2 NORTH CHARLES STREE||BALTIMORE|MD|21201||ENZYME IMMUNOASSAY, CANNABINOIDS|DR. BROWN'S HOME DRUG TESTING KIT|LDJ|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/1997|02/05/1997|||APPR|APPROVAL FOR: CHANGING THE TESTING LABORATORY TO AMERICAL MEDICAL LABORATORY (AML); INCLUDING HEROIN TESTING AS PART OF THE TEST SYSTEM; AND REVISED LABELING IN ASSOCIATION WITH THE ADDED HEROIN TESTING.
P950002|S002|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK INTERBODY FUSION SYSTEM|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/1997|05/09/1997|||APPR|APPROVAL OF THE ADDITION OF THE FOLLOWING SIZES TO THE BAK PRODUCT LINE: A) BAK IMPLANTS (MINOR DIAMETER (MM) X LENGTH (MM)) 11X20, 11X24, 11X28, 11X32, 11X36; 13X24, 13X28, 13X32, 13X36, 13X40; 15X28, 15X32, 15X36, 15X40, 15X44; 17X20, 17X32, 17X36, 17X40, 17X44; 19X24, 19X28, 19X32, 19X36, 19X40, 19X44; 21X28, 21X32, 21X36, 21X40, 21X44; AND (B) END CAPS (DIAMETER (MM)) 11; 19; AND 21.
P940010|S002|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE(TM) FIBER OPTIC DIFFUSER|MVG|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1997|01/09/1998|||APPR|Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated and approval to add a 2.0 cm diffuser to the DCYL Series of diffusers.
P880003|S067|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1997|08/08/1997|||APPR|APPROVAL FOR THE CORDIS TITAN(TM) MEGA AND TITAN(TM) MEGA XL FAMILY OF PTCA DILATATION CATHETERS.
P790002|S018|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/1997|06/11/1997|||APPR|APPROVAL FOR THE FLX(R) COILETTE WHICH WILL BE USED TO DELIVERY THE APPROVED REPETITIVE PULSE BURST SIGNAL PRODUCED BY THE EBI BONE HEALING SYSTEM MODEL 1200.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI FLX COILETTE TO BE USED WITH THE EBI BONE HEALING SYSTEM MODEL 1200 WHICH IS INDICATED FOR NONUNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDARTHROSES.
P900070|S016|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|META DDDR MODEL 1256 PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/1997|08/07/1997|||APPR|APPROVAL FOR EXTENSION OF SHELF LIFE FROM 12 MONTHS TO 18 MONTHS
P820018|S071|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/1997|08/07/1997|||APPR|APPROVAL FOR EXTENSION OF SHELF LIFE FROM 12 MONTHS TO 18 MONTHS
P940012|S001|AMERICAN MEDICAL SYSTEMS, INC.|10700 BREN ROAD WEST||MINNETONKA|MN|55343|||600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS||SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/1997|01/09/1998|||APPR|Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer patients for whom surgery and radiotherapy are not indicated.
P840064|S020|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(R)|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/1996|03/03/1998|||APPR|Approval for a change in method of sterilization from 12/88 EtO/Freon mixture to 100% Ethylene Oxide for a 0.75 mL fill volume of VISCOAT at Alcon's Puerto Rico manufacturing facility.
P920047|S007|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|E P TECH EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/1997|06/24/1997|||APPR|APPROVAL TO PERMIT EPT'S MANUFACTURING FACILITY, LOCATED AT 350 POTRERO AVE., SUNNYVALE, CA  94086, TO BE MOVED TO A NEW FACILITY AT 2710 ORCHARD PARKWAY, SAN JOSE, CA.
P940011|S001|LUMENIS, INC.|3959 WEST 1820 SOUTH||SALT LAKE CITY|UT|84104|||COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS||SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/1997|01/09/1998|||APPR|Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.
P850070|S009|AUTOMATIC LIQUID PACKAGING, INC.|2200 W. LAKE SHORE DR.||WOODSTOCK|IL|60098||Accessories, soft lens products|STERILE SALINE PRESERVED SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/1997|06/20/1997|||APPR|ELIMINATION OF ETHYLENE OXIDE STERILIZATION OF THE PIERCING CAP ATTACHED TO SEALED 12 OZ. AND 16 OZ. CONTAINERS OF STERILE PRESERVED SALINE SOLUTION.
P900061|S031|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/1997|03/13/1997|||APPR|APPROVAL FOR THE MODEL 6925 UPSIZING SLEEVE WHICH WILL ALLOW A 5.0 MM LEAD CONNECTOR TO FIT INTO A 6.5 MM CONNECTOR PORT OF A MEDTRONIC IMPLANTABLE DEFIBRILLATOR
N50510|S075|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/1997|04/24/1997|||APPR|APPROVAL FOR SPARFLOXACIN TO BE INCLUDED ON THE GRAM POSITIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 0.5, 1 AND 2 UG/ML)
P940010|S003|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE(TM) FIBER OPTIC DIFFUSER|MVG|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/18/1997|04/04/1997|||APPR|APPROVAL FOR LABELING CHANGES ASSOCIATED WITH THE INTRODUCTION OF A SECOND DISTRIBUTOR
P840024|S069|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/1997|05/15/1997|||APPR|APPROVAL FOR ADDITION OF A NEW STERILIZATION SITE AT GRIFFITH MICROSCIENCE, WILLOWBROOK, ILLINOIS.
P890027|S037|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/1997|04/01/1997|||APPR|APPROVAL FOR ADDITION OF A NEW STERILIZATION SITE AT GRIFFITH MICROSCIENCE, WILLOWBROOK, IL.
N50510|S076|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/1997|03/27/1997|||APPR|APPROVAL FOR LEVOFLOXACIN TO BE INCLUDED ON THE GRAM NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 1, 4 AND 8 UG/ML)
N50510|S077|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/1997|04/24/1997|||APPR|APPROVAL FOR LOMEFLOXACIN TO BE INCLUDED ON THE GRAM POSITIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIOS (EQUIVALENT TO 2, 4 AND 8UG/ML).
P790018|S029|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/1997|03/17/1997|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC INC., SPRING LAKE PARK, MN
P790019|S008|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|ABBOTT IMX(R) HAVAB(R)-M|LOL|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|01/31/1997|03/27/1997|||APPR|APPROVAL FOR A CHANGE IN THE REFERENCE  PANEL, TO REMOVE THE IGM ANTI-HBC POSITIVE PLASMA AND THE RHEUMATOID FACTOR POSITIVE PLASMA MIXED WITH HIGH TITER ANTI-HAV IGG POSITIVE PLASMA
P930034|S008|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX AND SVS APEX PLUS EXCIMER LASER WORKSTATIONS|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/1997|10/08/1998|||APPR|Approval for the central island pretreatment software option.
P960001|S001|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|ENDURANCE BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/1997|11/12/1997|||APPR|Approval for new PMMA/MMA-Styrene co-polymer formulation.  The device, as modified, will be marketed under the trade Endurace Bone Cement and is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal srugical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other condtions and revision of previous arthroplasty.
P810046|S174|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS TX2000 VP CORONARY DILITATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/1997|06/11/1997|||APPR|APPROVAL FOR A MODIFICATION TO THELABELING OF THE ACS RX COMET(TM) CORONARY DILATATION CATHER AND ACS TX2000(TM) CORONARY DILATATION CATHETER.
P920004|S006|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (TM)|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/1997|04/15/1997|N||APPR|APPROVAL FOR A CHANGE TO THE INDICATIONS FOR USE TO INCLUDE SUE OF VASOSEAL(R) FOLLOWING STENT IMPLANTATION.  THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE IS NOW INDICATED FOR USE IN REDUCING TIEM TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY, BALLOON ANGIOPLASTY OR STENT PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH.  THE VASOSEAL(R) VHD IS ALSO INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS IN BALLOON ANGIOPLASTY AND STENT PATIENTS WHEN IMMEDIATE SHEALTH REMOVAL IS DESIRED.  HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DEMONSTRATED.
P910066|S005|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/26/1997|05/09/1997|||APPR|APPROVAL FOR THE USE OF IN VITRO, AND IN VIVO DATA FROM STUDIES INVESTIGATING THE BIOLOGICAL EFFECTS OF COMBINED MAGNETIC FIELDS ON BONE HEALING AT THE CELLULAR LEVEL.
P890055|S003|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/26/1997|09/22/1997|||APPR|Approval for the intraspinal delivery of preservative free morphine for patient with intractable chronic pain.
P900070|S017|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|TEMPO VR 1102 AND TEMPO V 1902|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/1997|08/27/1997|||APPR|Approval for the Tempo DR Model 2102, Tempo D Model 2902, Tempo VR Model 1102, and Tempo V Model 1902 Pulse Generators.
P860019|S120|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) NC REBEL (TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/1997|08/01/1997|||APPR|APPROVAL FOR THE NC REBEL(TM) PTCA CATHETER.
P860004|S036|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/1997|07/17/1997|||APPR|Approval for the use of an alternative bead blasted shield surface finish long with an associated change to the laser engraving for the Medtronic SynchroMed pump's titanium shields.  The bead blasted shield finish, and associated continuous laser power engraving process, may serve as an alternative to the current straight line shield finish in that either finish may be used on the device.
P810002|S043|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/1997|07/23/1998|||APPR|Approval for the SJM(R) Master Series, Models ATJ-503, AETJ-504, MTJ-503, and METJ-504, with a PTFE sewing cuff.
P860004|S037|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/28/1997|06/28/1999|N||APPR|Approval for a labeling change to include the use of the SynchroMed Infusion System in a magnetic resonance imaging (MRI) environment.
P890025|S010|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY|MGU|TX|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/1997|02/13/1998|||APPR|Approval for change in monoclonal antibody manufacturing site from Sandoz Pharmaceuticals AG., Switzerland to Abbott Laboratories, Abbott Park, IL USA, under the trade name TDx(R)/TDxFLx(R) Cyclosporine Monoclonal Whole Blood Assay,  It is indicated for the quantitative measurement of cyclosporine as an aid in the management of cardiac, liver, and renal transplant patients.
P910064|S013|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60654||Condom, female, single-use|REALITY FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/28/1997|03/07/1997|N||APPR|APPROVAL FOR 1)A MODIFICATION OF THE SHELF LIFE PROTOCOL TO REVISE THE FILM STRENGTH SPECIFICATION FROM 35 MPA TO 25.8 MPA; 2) A MODIFICATION ON THE SHELF LIFE PROTOCOL TO ASSESS THE FINAL RESULTS OF EACH LOT ON AN INDIVIDUAL BASIS, INSTEAD OF AS AN AVERAGE OF A SERIES; AND 3) AN EXTENSION OF THE PRODUCT SHELF LIFE FROM 36 MONTHS TO 60 MONTHS FOR PRODUCT PRODUCT MANUFACTURED AT BOTH THE WISCONSIN PHARMACAL AND THE CHARTEX MANUFACTURING PLANTS.
P830071|S009|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-SOAK(R) CONDITIONING SOLUTION ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/1997|03/19/1997|||APPR|APPROVAL FOR A MODIFICATION IN THE PACKAGE INSERT TO INCLUDE ADDITION OF THE FOLLOWING STATEMENT IN THE DIRECTIONS SECTIONS:  "YOU MAY STORE YOUR LENSES IN THE UNOPENED CASE UNTIL READY TO WEAR, UP TO A MAXIMUM OF THIRTY DAYS.  IF YOUR LENSES ARE STORED FOR LONGER PERIODS OF TIME, THEY MUST BE CLEANED AND DISINFECTED WITH FRESH SOLUTION EVERY THIRTY DAYS AND PRIOR TO WEAR."
P830034|S033|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|OPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION|LPN|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/1997|03/19/1997|||APPR|APPROVAL FOR A MODIFICATION IN THE PACKAGE INSERT TO INCLUDE ADDITION OF THE FOLLOWING STATEMENT IN THE DIRECTIONS SECTIONS:  "YOU MAY STORE YOUR LENSES IN THE UNOPENED CASE UNTIL READY TO WEAR, UP TO A MAXIMUM OF THIRTY DAYS.  IF YOUR LENSES ARE STORED FOR LONGER PERIODS OF TIME, THEY MUST BE CLEANED AND DISINFECTED WITH FRESH SOLUTION EVERY THIRTY DAYS AND PRIOR TO WEAR."
P830034|S034|ALCON LABORATORIES|R||VAN NUYS|CA|30348||Accessories, soft lens products|ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 81573|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/1997|07/02/1997|||APPR|APPROVAL TO ALLOW FOR THE USE OF ALCON MULTI-PURPOSE SOLUTION ID 81573 (OPTI-ONE MULTI-PURPOSE SOLUTION) AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(R) DAILY PROTEIN REMOVER.
P870036|S043|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1997|08/12/1997|||APPR|APPROVAL FOR: A) THE ADDITIO OF 15 MM LENGTHS TO THE MILLENIA(TM) CORONARY BALLOON DILATATION CATHETER LINE; B) A CHANGE IN THE METHOD USED TO TEST FOR BURST STRENGTH OF THE BALLOONS; AND C) THE ADDITION OF THE FOLIO BALLOON SHAPING TOOL AS AN ACCESSORY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC(R) MILLENIA(TM) 15 CORONARY BALLOON DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P820001|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-FREE SUPRACLENS|LPN|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/1997|07/02/1997|||APPR|APPROVAL TO ALLOW FOR THE USE OF ALCON MULTI-PURPOSE SOLUTION ID 81573 (OPTI-ONE MULTI-PURPOSE SOLUTION) AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(R) DAILY PROTEIN REMOVER.
P810046|S175|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX LIFESTREAM|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1997|07/03/1997|||APPR|APPROVAL FOR AN ALTERNATE METHOD OF STERILIZATION FOR THE ACS RX LIFESTREAM(TM) CORONARY DILATATION CATHETER.
P880065|S003|Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||PULSE-GENERATOR, PROGRAM MODULE|MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER|LOT|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/1997|09/08/1997|||APPR|Approval for: 1) an alternate manufacturing and sterilization facility; 2) use of the Oxyfume 2000 sterilant gas mixture for sterilization; 3) use of a parametric release instead of the biological indicators product release process; and 4) use of a revised labeling format, which replaces the Mansfield name with the SCIMED(R) name.
P910058|S009|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|CHIROFLEX(TM)MODEL C10UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/1997|05/07/1997|||APPR|APPROVAL FOR REVISED LABELING
P910056|S006|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/1997|05/07/1997|||APPR|APPROVAL FOR REVISED LABELING.
P930012|S006|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|THE WRAP(PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/1997|05/29/1997|||APPR|APPROVAL FOR THE WRAP(TM) PTCA CATHETER.
P830026|S069|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX5000 (TM) GRAPHICS PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/1997|04/28/1997|||APPR|APPROVAL FOR ALTERNATE COMPONENTS TO BE USED IN THE MANUFACTURE OF THE RX5000(TM) GRAPHICS PROGRAMMER
P810055|S067|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/1997|05/28/1997|||APPR|APPROVAL FOR TIER A POSTERIOR CHAMBER INTRAOCULAR LENS MODEL 777A.  THIS INTRAOCULAR LENS IS INDICATED FOR USE IN THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE AND OLDER, WHO ARE UNDERGOING A PRIMARY LENS IMPLANTATION, IN EITHER THE CILIARY SULCUS OR CAPSULAR BAG FOLLOWING AN EXTRACAPSULAR CATARACT EXTRACTION.
P850020|S009|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA(TM) COLUMN|LKN|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/1997|04/17/1997|||APPR|APPROVAL FOR THE CONSOLIDATION OF MANUFACTURING OPERATIONS AT CYPRESS BIOSCIENCE, 14787 NE 95TH ST., REDMOND, WA 98052.
P850022|S009|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|SPINALPAK(R) STIMULATOR|LOF|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/13/1997|09/24/1999|00M-0901||APPR|Approval for SpinalPak Bone Growth Stimulator.  The device is indicated as a noninvasive bone growth stimulator for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
P790018|S030|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/1997|09/29/1997|||APPR|Approval for the Rotatable Aortic Valved Collagen Impregnated Conduit (Rotatable AVCIC, Model R7700).
P810046|S176|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX LIFESTREAM|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/1997|07/17/1997|||APPR|Approval for ACS RX LIFESTREAM(TM) Coronary Dilatation Catheter with 4.5 mm and 5.0 mm balloon diamters by 15 mm, 20 mm and 30 mm balloon lengths.
P830026|S070|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX5000 (TM) GRAPHICS PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/1997|04/17/1997|||APPR|APPROVAL FOR THE RX5000 MODEL 522-12 VERSION 2.01.03 OPERATING SYSTEM.
P860019|S121|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/14/1997|09/12/1997|||APPR|Approval for a new indication for use, the post-delivery expansion of the Palmaz-Schatz Coronary Stent, for the 3.0 mm - 4.0 mm balloon models of the NC Bandit(TM) PTCA Catheter.
P920015|S012|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT TM MODEL 6942 LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/18/1997|07/18/1997|||APPR|Approval for the Medtronic(R) Sprint(TM) Model 6942 Lead System.
P870076|S006|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM|KNH|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/1997|03/21/1997|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CIRCON-SURGITEK, 3037 MT. PLEASANT ST., RACINE, WI.
P950019|S001|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/18/1997|04/11/1997|||APPR|APPROVAL FOR ADDITIONAL INSTRUMENTS AND A CHANGE TO THE SURGICAL TECHNIQUE MANUAL.
P920034|S001|MEDIREX, INC.|49 WALNUT PARK||WELLESLEY HILLS|MA|02181||Lithotriptor, extracorporeal shock-wave,urological|TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS|LNS|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/18/1997|03/26/1997|||APRL|APPROVAL FOR LABELING CHANGES DESCRIBING THE TRANSPORTABILITY OF THE DEVICE
P810037|S010|KONTRON CARDIOVASCULAR|9 PLYMOUTH ST.||EVERETT|MA|02149||MONITOR, CARBON-DIOXIDE, CUTANEOUS|KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505|LKD|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/1997|05/22/1998|||APPR|Approval for converstion of the stand-alone MicroGas 7640 P02/PC02 Monitor to a plug-in module for the Kolormon Plus host.  The device, as modified, will be marketed under the trade name Kontron Kolormon Plus BloodGas Module 7267-505 and is indicated for cutaneous measurement of blood gas tensions (P02 or PC02).
P950002|S003|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK INTERBODY FUSION SYSTEM|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/1997|10/15/1997|||APPR|Approval for the BAK/RLP (Reduced Lateral Profile) implant configuration of the BAK Interbody Fusion System.
P960001|S002|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|ENDURANCE BONE CEMENT|LOD|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/1997|04/03/1997|||APPR|APPROVAL FOR PACKAGING DEPUY 1 BONE CEMENT POWDER WITHOUT THE FOIL POUCH
P940008|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RES-Q(TM) MICRON ICD SYSTEM||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/1997|04/25/1997|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 531-30 RX2000 GRAPHICS PROGRAM MODULE
P930038|S002|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|||N|03/21/1997|04/25/1997|||APPR|APPROVAL FOR LABELING CHANGES
P920051|S006|KARL STORZ ENDOSCOPY-AMERICA, INC.|1201 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER        VERSION)                                     ANSPORTABLE VERSION)|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/1997|03/27/1997|||APRL|APPROVAL FOR THE OEC SERIES 9600 MOBILE IMAGING UNIT AND A PORTABLE COLLISION PROTECTOR TO BE USED WITH A TRANSPORTABLE VERSION OF YOUR SLX LITHOTRIPTER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRANSPORTABLE MODULITH(R) SLX LITHOTRIPTER AND IS INDICATED FOR USE IN THE NONINVASIVE FRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER.
P880091|S010|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/1997|06/30/1997|||APPR|APPROVAL FOR LENS MODEL AA-4207VF.  THE DEVICE IS TO BE PLACED IN THE CAPSULAR BAG OF THE EYE AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM THE CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION OR EXTRACAPSULAR CATARACT EXTRACTION.
P900023|S021|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/1997|04/16/1997|||APPR|APPROVAL FOR AN INCREASE IN THE STERILIZER LOAD SIZE.
P830055|S053|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/1997|02/12/1998|||APPR|Approval for gas plasma sterilization of the textrued rotating patella components of the new jersey LCS(R) Total Knee System.
P900023|S022|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1997|06/04/1997|||APPR|APPROVAL FOR MODIFYING THE INDICATIONS FOR USE.
P950037|S001|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/1997|03/13/1998|||APPR|Approval for a capacitive sensor, integrated circuit change and its supporting circuityr, hybrid circuit modification, battery change, pacemaker housing change, modified header, PMS 1000 C programmer, and the SWM 1000 F01.B00.U Software.  The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following:Actros DR, D, SR, and S models, PMS 1000 C programmers, SWM 1000 (Version F01.B00.U).  Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increase pacing rates concurrent with physical activity.  Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrom (i.e., bradycardiatachcardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome.  Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of te dual-chamber or atrial pacing modes.  Dual-chamber modes are specfically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with coduction distrurbances, and tachyarrhythmias that are suppressed by chronic pacing.
P930038|S004|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/1997|04/25/1997|||APPR|APPROVAL FOR MODIFICATIONS TO THE ANGIO-SEAL(TM) MANUFACTURING PROCESS TO ELIMINATE THE POTENTIAL FOR DAMAGE OF THE SUTURE COMPONENT.
P860040|S014|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, extended wear|BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1997|11/04/1997|||APPR|Approval for adding a visibility tint to the contact lens and revised labeling for the spherical lens to reflect the addition ofthe visibility tint.  There are no changes in the previously approved indications for use.
P910031|S015|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|ORACLE MEGASONICS FIVE-64 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/1997|05/01/1998|||APPR|Approval for Oracle MegaSonics Five-64(TM) PTCA Catheter.  The device, as modified, will be marketed under the trade name Oracle MegaSonics Five-64(TM) PTCA Catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion.  The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) dimensional measurements from the image.
P940002|S001|SULZERMEDICA|9900 SPECTRUM DR.||AUSTIN,|TX|78717||PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NATURAL-KNEE(R) WITH CSTI(TM)|MBD|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/1997|04/30/1997|||APPR|APPROVLA FOR POSTAPPROVAL PROTOCOL AND MODIFICATIONS TO YOUR PACKAGE INSERTS
P950001|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/1997|09/19/1997|||APPR|Approval for a manufacturing site lcoated at Cardiac pacemakers, Inc., Del Caribe, Road 698 Lot No. 12, Dorado, PR 00646.
P910073|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/1997|09/19/1997|||APPR|Appproval for a manufacturing site located at Cardiac Pacemakers, Inc., Del Caribe, Road 698 Lot No. 12, Dorado, PR 00646.
P930034|S009|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/1997|03/11/1998|98M-0329|05/27/1998|APPR|Approval for the SVS Apex Plus Excimer Laser Workstation and emphasis(R) disc.  These devices are indicated to perform myopic astigmatic photorefractive keratectomy (Toric PRK): 1) for the reduction or elimination of mild to moderate myopia (-1.00 to < -6.00 D) and concomitant reduction or elimination of mild to moderate astigmatism (-1.00 to < -4.00D), in which the combined attempted correction must be < -6.00D spherical equivalent at the spectacle plane; 2) in patients with documentation of a stable manifest refraction(+- 1D) over the past year; and, 3) in patients who are 21 years of age or older.
P830055|S054|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/07/1997|04/30/1997|||APPR|APPROVAL FOR A CHANGE TO THE DEPTH OF THE BONE GRAFT POCKETS OF THE TEXTURED AND POROUS COATED FEMORA COMPONENTS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM
P950014|S006|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1997|11/24/1997|||APPR|Approval for changes to the Prostatron(R) software program to include a high energy treatment protocol (using either the single or dual-module hardware configurations).
P960007|S001|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT-TC(TM)|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/08/1997|10/17/1997|||APPR|Approval  for the new indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
P850035|S022|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/08/1997|04/22/1997|||APPR|APPROVAL FOR THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR WHICH IS A MODIFICATION OF THE SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR.  THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR HAS A SMALLER GENERATOR CASE THAN THE SPF-XL II IMPLANTALBLE SPINAL FUSION STIMULATOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR AND IS INDICATED FOR USE AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 3 OR MORE LEVELS.
P900070|S018|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|MODEL 1256D META MV CARDIAC PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/1997|04/29/1997|||APPR|APPROVAL FOR ALTERNATE MANUFACTURING SITE LOCATED AT SYLMAR, CA.
P850064|S012|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER|LSZ|AN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/1997|05/16/1997|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE AN ADDITIONAL WARNING ADVISING AGAINST TROUBLESHOOTING WHILE THE VENTILATOR IS IN OPERATION.
P960024|S001|CIBA VISION CORPORATION|11460 JOHNS CREEK PKWY.||DULUTH|GA|30097||Accessories, solution, ultrasonic cleaners for lenses|UNIZYME(TM) ENZYMATIC CLEANER|LYL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/1997|07/03/1997|||APPR|Approval for addition of Ciba Vision's SOLOCare(TM) Brand Multi-Purpose Solution to the labeling of the Unizyme(TM) Enzymatic Cleaner as a diluent to be used sequentially with the Unizyme(TM) enzyme.
P950022|S002|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|SPL LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/14/1997|09/11/1997|||APPR|Approval for the Ventritex(R) SPL(TM) Lead system Models SP01, SP02, SP03, And SP04.
P930038|S005|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/1997|05/01/1997|||APPR|CHANGE TO THE INDICATIONS FOR USE FOR THE ANGIO-SEAL(TM) DEVICE.  THE ANGIO-SEAL(TM) HEMOSTATIC PUNCTURE CLOSURE DEVICE IS NOW INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR INTERVENTIONAL PROCEDURES USING AN RETROGRADE APPROACH AND AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.
P950034|S005|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|Real-Time Process|Postapproval Study Protocol - ODE/OIR|N|04/16/1997|02/25/1998|||APPR|In this supplment the applicant agrees to submit an Investigational Device Exemptions (IDE) application for the modified postapproval safety study, is approved.  We believe that this study, with the modifications as discussed, will satisfy the condition ofapproval for this PMA, but we may have additional comments on the IDE botha s it related to the objectives of the postapproval study, depending on your responses, and your objective of collecting outcomes data on the incidence of small bowel obstruction.
P960004|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|ADDITION OF ALTERNATE TUBING EXTRUDER|DXY|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/1997|10/23/1997|||APPR|Approval for the use of an alternate tubing extrusion process for the Pellethane(R) 55D used in the ThinLine(TM) family of pacing leads.
P850077|S023|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS|LPM|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/1997|05/19/1997|||APPR|APPROVAL FOR AN ALTERNATE MOLDED LENS MANUFACTURING PROCESS FOR A MULTIFOCAL LENS DESIGN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND IS INDICATED FOR DIALY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENS IS INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE PRESBYOPIC, WITH OR WITHOUT ASSOCIATED AMETROPIA.  THE LENS MAY BE WORN BY PERSONS WHO REQUIRE UP TO +3.00 DIOPTERS (D) OF ADD AND WHO EXHIBIT REFRACTIVE ASTIGMATISM OF NO MORE THAN 1.50 D THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENS RANGES IN SPHERICAL POWER FROM -20.00D TO +10.00 D.
P900070|S019|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|MODEL 1256D META MV CARDIAC PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1997|04/29/1997|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR MODEL 9602 PROGRAMMER.  THE SITE IS LOCATED AT PACESETTER, INC., 15900 VALLEY VIEW CT., SYLMAR, CA
P810046|S177|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ESPRIT|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/1997|09/19/1997|||APPR|Approval for the ACS RX ESPRIT(TM) Coronary Dilatation Catheter.  THe device is indicated for: 1)balloon dilatation fo the stenotic portion of a coronary artery or bypass draft stenosis for the purpose of improving myocardial perfusion; and 2)balloon dilatation of a coronary artery occlusion ofr the purpose of restoring coronary flow in patients iwth S-T segment elevation myocardial infarction.
P820060|S011|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AXSYM AFP|LOJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/1997|05/16/1997|||APPR|APPROVAL FOR THE ADDITION OF A SYSTEM PERFORMED AUTOMATED DILUTION PROTOCOL FOR A 1:101 SAMPLE DILUTION OF AMNIOTIC FLUID AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1)HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER. (2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION OT AID INT HE DETECTION OF FETAL OPEN NEURAL TUBE DETECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD.
P910074|S001|EUREKA LABORATORIES, INC.|CHEMIN CHARLEMAGNE|41220 CELLETTES|||||Accessories, soft lens products|CONTACLAIR MULTI-PURPOSE SOLUTION|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/18/1997|07/03/1997|||APPR|APPROVAL FOR EXPANDING THE INDICATIONS TO INCLUDE USE WITH SILICONE/ACRYLATE AND FLUOROSILICONE/ACRYLATE RIGID GAS PERMEABLE (RGP) CONTACT LENSES.  WHEN USED WITH RGP LENSES, THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME, CONTACLAIR(R) RGP MULTI-PURPOSE SOLUTION, AND IS INDICATED FOR USE IN CLEANING, RINSING, DISINFECTING AND STORING DAILY AND EXTENDED WEAR RGP CONTACT LENSES.
P840024|S070|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1997|06/11/1997|||APPR|APPROVAL TO IMPLEMENT A DESIGN CHANGE TO THE TWO-PIN SOCKET ON THE HEADSET MICROPHONE.  THE TRANSMITTING COIL IS CONNECTED TO THE MICROPHONE VIA A CABLE WHICH IS PLUGGED INTO THIS TWO-PINC SOCKET.  THIS CHANGE WOULD ALSO ENTAIL MAKING A SLIGHT MODIFICATION TO THE DESIGN OF THE SHELL OF THE HEADSET MICROPHONE IN ORDER TO ACCOMMODATE THE NEW DESIGN OF THE TWO-PIN SOCKET.  THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT IS INDICATED FOR USE IN ADULTS WITH BILATERAL, SENSORINEURAL, SEVERE-TO-PROFOUND DEAFNESS, AGES 18 YEARS AND OLDER, WHO OBTAIN UP TO 30% SPEECH RECOGNITION ON TESTS OF RECORDED SENTENCE MATERIALS IN THE BEST-AIDED CONDITION.  IT IS INDICATED FOR USE IN CHILDREN WITH BILATERAL, SENSORINEURAL, PROFOUND DEAFNESS, AGES 2 YEARS TO 17 YEARS, WHO OBTAIN LITTLE OR NOT BENEFIT FROM CONVENTIONAL AMPLIFICATION IN THE BEST-AIDED TEST CONDITION.
P890027|S038|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1997|06/11/1997|||APPR|APPROVAL TO IMPLEMENT A DESIGN CHANGE TO THE TWO-PIN SOCKET ON THE HEADSET MICROPHONE.  THE TRANSMITTING COIL IS CONNECTED TO THE MICROPHONE VIA A CABLE WHICH IS PLUGGED INTO THIS TWO-PIN SOCKET.  THIS CHANGE WOULD ALSO ENTAIL MAKING A SLIGHT MODIFICATION OT THE DESIGN OF THE SHELL OF THE HEADSET MICROPHONE IN ORDER TO ACCOMMODATE THE NEW DESIGN OF THE TWO-PIN SOCKET.
P880027|S048|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BONNIE (TM) PTCA CATHERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/1997|10/09/1997|||APPR|Approval for a new model PTCA catheter.  This device, as modified, will be marketed under the trade name Bonnie(TM) Sliding Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P880038|S034|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 9602 PROGRAMMER|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/1997|04/29/1997|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE MODEL 9602 PROGRAMMER. THE SITE IS LOCATED AT PACESETTER, INC., 15900 VALLEY VIEW CT., SYLMAR CA.
P820018|S072|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MODEL 9602 PROGRAMMER|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/1997|04/29/1997|||APPR|ALTERNATE MANUFACTURING SITE FOR THE MODEL 9602 PROGRAMMER.  THE SITE IS LOCATED AT PACESETTER, INC., 15900 VALLEY VIEW CT., SYLMAR, CA.
P920023|S003|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT|UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS|MER|GU|Real-Time Process|Postapproval Study Protocol - ODE/OIR|N|04/25/1997|04/29/1997|||APPR|APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDIES.
P790019|S009|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|ABBOTT IMX(R) HAVAB(R)-M|LOL|MI|Special (Immediate Track)||N|04/23/1997|05/28/1997|||APPR|APPROVAL FOR A CHANGE IN THE SPECIFICATIONS FOR THE POSITIVE CONTROL SAMPLE TO STANDARD RATIO FROM 0.90-1.15 TO 0.85-1.15, AND A CHANGE IN THE EVALUATION OF THE HEPATITIS A VIRUS SOLUTION AND THE HAVAB(R)-M EIA CONJUGATE FROM A SAMPLE TO STANDARD RATIO TO A SAMPLE TO TARGET RATIO.
P810002|S044|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track|Other Report|N|04/23/1997|10/20/1997|||APPR|Approval for the termination of the PVG and CAVG postapproval studies.  These studies were required by the supplement 3 and supplement 27 approval letter dated March 1, 1984, and February 10, 1997, respectively.
N17755|S049|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|BONE CEMENT|OSTEOBOND(TM) COPOLYMER BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/1997|09/05/1997|||APPR|Approval for the addition of a second location to manufacture Osteobond Copolymer Bone Cement.
P870050|S007|TRP COMPANY|1575 DELUCCI LANE #115||RENO|NV|89502||Accessories, soft lens products|SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/1997|10/15/1997|||APPR|Approval for an expansion of the indicatiosn for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
P870051|S007|TRP COMPANY|1575 DELUCCI LANE #115||RENO|NV|89502||Accessories, soft lens products|SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)|LPN|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/1997|10/15/1997|||APPR|Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
P960043|S001|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/1997|11/05/1997|||APPR|Approval for modified Percutaneous Vascular Surgical devices.  The devices, as modified, will be marketed under the trade names Techstar(TM) 6 French Percutaneous Vascular Surgical (PVS) System and Techstar(TM) XL 6 French PVS System and are indicated for the percutaneous delivery of sutures for closing the common femoral artery access site of patients who have undergone diagnostic catheterization procedures using 5 to 6 French sheaths.
P850076|S009|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED DAILY CLEANER|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/1997|07/02/1997|||APPR|APPROVAL FOR RELOCATION OF THE GRIFFITH MICROSCIENCE STERILIZATION SITE TO 27 PARK RD., GLEN FALLS, NY.
P850075|S009|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|SORBIC ACID PRESERVED LENS LUBRICANT|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/1997|07/02/1997|||APPR|APPROVAL FOR RELOCATION OF THE GRIFFITH MICROSCIENCE STERILIZATION SITE TO 27 PARK RD., GLEN FALLS, NY.
P840069|S007|PACO PHARMACEUTICAL SERVICES, INC.|1200 PACO WAY|BUILDING 19|LAKEWOOD|NJ|08701||Accessories, soft lens products|CHARTER LABS SALINE SOLUTION|LPN|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/1997|07/02/1997|||APPR|APPROVAL FOR RELOCATION OF THE GRIFFITH MICROSCIENCE STERILIZATION SITE TO 27 PARK RD., GLEN FALLS, NY.
P910023|S026|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1997|07/01/1997|||APPR|APPROVAL FOR THE "C" HEADER CONFIGURATION FOR THE CONTOUR(TM) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM.
N18033|S030|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/02/1997|05/14/1997|||APPR|APPROVAL TO MAKE A MINOR CHANGE IN THE INITIATOR RATIO (INCREASED AMOUNT) FOR THE ACUVUE(R) (ETAFILCON A) CONTACT LENS, WHICH WAS APPROVED AS N18-033/S29 ON OCTOBER 7, 1996.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE CURRENT TRADE NAME WITH NO CHANGE TO THE INDICATIONS FOR USE OR THE ESTABLISHED SHELF-LIFE.
P920014|S006|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE(R) 1000A IP LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/1997|05/22/1997|||APPR|APPROVAL FOR A CHANGE TO THE INTERIM PERCUTANEOUS DRIVE LINE DESIGN
P860064|S008|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DUPEN LONG TERM EPIDURAL CATHETER|LNY|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1997|08/08/1997|||APPR|APPROVAL FOR A CHANGE IN THE STERILANT FORM 12% FREON/ 88% ETHYLENE OSIDE TO 100% ETHYLENE OXIDE AND TO CHANGE THE STERILIZATION FACILITY FROM DAVOL, INC., A C.R. BARD FACILITY IN CRANSTON, R.I., TO A CONTRACT STERILIZER, SOREX MEDICAL, INC., IN SALT LAKE CITY, UTAH.
P890003|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/05/1997|06/03/1998|||APPR|Approval for new pacing lead models.  The devices, as modified, will be marketed under the trade names:  Medtronic Models 5038-58, 5038-65, 5038-52, 5038S-58, and 5038L-65 CapSure VDd-2 and Vitatron Models IMW 14Q/15Q/16Q/17Q/18Q Brilliant S+ VDD Pacing Leads and are indicated for bipolar sensing in the atrium and bipolar sensing and pacing in the ventricle when used with current Medtronic(R) VDD pacemakers.
P900061|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/05/1997|06/12/1997|||APPR|APPROVAL FOR LABELING CHANGES (LANGUAGE FOR "INDICATIONS FOR USE").
P810002|S045|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/1997|10/21/1999|||APPR|Approval for an increase of the orifice lot sizes during the pyrolytic carbon coating process at the Woodrige manufacturing facility.
P960007|S002|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT-TC(TM)|MGR|SU|Real-Time Process|Postapproval Study Protocol - ODE/OIR|N|05/05/1997|05/29/1998|||APPR|Approval for a post approval study assessing the incidence of burn wound infection in in patients who require a temporary wound covering, Dermagraft-TC, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patients who require sucha covering prior to autograft placement.
P900060|S014|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/1997|05/27/1997|||APPR|APPROVAL FOR REDUCTION IN THE INCUBATION PERIOD FOR BIOLOGICAL INDICATORS FOR STERILITY RELEASE TO THREE DAYS.
P850077|S024|COOPER VISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/1997|06/20/1997|||APPR|APPOVAL FOR CONSOLIDATED AND REFORMATEED LABELING FOR THE ECLIPSE, SUNFLEX, TORIC 15.0, REVOLUTION, SPORTSOFT, APHAKIC, AND MULTIFOCAL LENSES.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ECLIPSE(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, TORIC 15.0(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SUNFLEX(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, REVOLUTION (TM) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SPORTSOFT(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) APHAKIC EXTENDED WEAR CONTACT LENSES, SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) APHAKIC EXTENDED WEAR CONTACT LENS, AND SUNSOFT MULTIFOCAL(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES. THE INDICATIONS AND SHELF-LIFE FOR THESE DEVICES REMAIN UNCHANGED FROM THAT PREVIOUSLY APPROVED.
P910023|S027|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/07/1997|09/15/1997|||APPR|Approval of Programmer Model PR-3500, Programmer Wand Model AC-3500 Programmer Software Version 5.0 and PR-3500 Accessories.
P860019|S122|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Special (Immediate Track)|Other Report|N|05/09/1997|06/05/1997|||APPR|APPROVAL FOR ADDITIONAL STATEMENTS TO SECTIONS F4 AND 4G OF THE INSTRUCTIONS FOR USE ADVISING THE USER TO DEPRESS THE LOCK BUTTON BEFORE ADVANCING OR WITHDRAWING THE CONTRAST DISPLACEMENT ROD (CDR).
P830055|S055|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEW JERSEY LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/09/1997|06/11/1997|||APPR|APPROVAL FOR AN INCREASE IN THE THICKNESS OF THE ALL-POLYETHYLENE THREE-PEGGED PATELLA COMPONENTS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM
P880003|S068|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/1997|11/18/1997|||APPR|Approval for an additional marker band on the 10 mm balloon length of the THOR(TM) PTCA Dilatation Catheters.
P870024|S041|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (other material) - daily|FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES|HQD|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/1997|08/25/1997|||APPR|Approval for Viscon Contact Lens Manufacturing Ltd., 10214-112 Street, Edmonton, Alberta, Canada T5K1M4, as an alternate manufacturing and distribution site for the device.
P880027|S049|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|TAKUMI OVER THE WIRE PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/12/1997|11/10/1997|||APPR|Approval for a new model PTCA catheter.  The device, as modified, will be marketed under the trade name Takumi(TM) Over the Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P810055|S068|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/14/1997|10/22/1997|||APPR|Approval to extend the dioptric power range of Model 812B to -10D to +40D.  The device is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoing a primary lens implantation, in either the ciliary sulcus or capsular bag following an extracapsular cataract extraction.
P860005|S007|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)|MBS|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/1997|05/30/1997|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, INTERNATIONAL, 344 BONNIE CIRCLE, CORONA, CA.
P810002|S046|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1997|03/24/1998|||APPR|Approval for the addition of silver to the sewing cuff of the St. Jude Medical Mechanical Heart Valve SJM Masters Series.  The device, as modified, will be marketed under the trade name St. Jude Medical Mechanical Heart Valve SJM Masters Series with Silzone Coating and will be available in the following model numbers and sizes:  AS-601 and AECS-602 (19, 21, 23, 25, 27, 29, and 31 mm), MS-601 and MECS-602 (19, 21, 23, 25, 27, 29, 31, and 33 mm), and AHPS-605, MHPS-605, AEHPS-606, and MEHPS-606 (17, 19, 21, 23, 25, and 27 mm).
P890057|S009|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/1997|07/08/1997|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING OF THE PATIENT CIRCUIT TO ULTRASONIC WELDING.
P900061|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1997|07/02/1997|||APPR|APPROVAL FOR A MODIFICATION OF THE CX CONNECTOR MODULE FORTHE MODEL 7223 MICRO JEWEL(TM) II.
P910023|S028|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/09/1997|05/29/1997|||APPR|APPROVAL TO DISTRIBUTE THE DEVICE NOTIFICATION UPDATE LETTER AND THE CRYSTAL DATA.
P910031|S016|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|ORACLE MEGASONICS FIVE-64 PTCA CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/1997|06/27/1997|||APPR|APPROVAL FOR THE ADDITION OF THE 30 MM BALLOON LENGTH TO THE ARC(TM) BALLOON CORONARY DILATATION CATHETERS.
P860004|S038|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/1997|09/18/1997|||APPR|Approval for the inclusion of an add'l precaution regarding the complications associated with the development of an "inflammatory mass" at the tip of the implanted catheter to the SynchroMed Infusion System Techinical Manual and the Model 8703W InDura Intraspinal Catheter Technical Manual.
P870072|S004|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/1997|07/10/1997|||APPR|Approval for changing the test methodology for measuring molecualr weight of BPS-215 from gel permeation chromatography to intrinsic viscosity during the manufacturing process.
P940005|S002|ADVANCED TECHNOLOGY LABORATORIES, INC.|22100 BOTHELL EVERETT HWY.|P.O. BOX 3003|BOTHELL|WA|98041|3003|System, imaging, pulsed doppler, ultrasonic|HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD|IYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/1997|07/21/1998|||APPR|Approval for design change from HDI 3000(R) Ultrasound System with L10-5 Scanhead to HDI 3000(R) Ultrasound System with L12-5 Scanhead for the indication of an adjunct o mammography and physical breast examination, to provide a high degree of physician confidence in differentiating benign from malignant or suspicious breast lesions.  This device provides the physician with additional information to guide a biopsy decision.  Utlity of this system has been demonstrated for lesions with an indeterminate Level of Suspicion (LOS 2-4) by conventional diagnostic modalities.  Using the HDI system in the evaluation of solid mass characteristics can reduce the number of biopsies perofrmed on indeterminate lesions.
P790017|S062|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI APOLLO RELY OVER-THE-WIRE BALLON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/1997|12/01/1997|||APPR|Approval for a new PTCA catheter line.  The device, as modified, will be marketed under the trade name USCI* Apollo* Rely Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel* Coating and Miniquet* Device and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P950034|S006|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/1997|06/30/1997|||APPR|APPROVAL FOR A 24 MONTH EXPIRATION DATE FOR SEPRAFILM BIORESORBABLE MEMBRANE.
P960043|S002|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/1997|12/29/1997|||APPR|Approval for modified Percutaneous Vascular Surgical (PVS) Systems.  The devices, as modified, will be marketed under the trade names Prostar(R) Plus 8 French, Prostar(R) Plus 10 French, and Prostar(R) XL 8 French PVS Systems.  The Prostar(R) Plus and Prostar(R) XL PVS Systems consist of a PVS Device and a Perclose(R) Knot Pusher.  The Prostar(R) Plus and Prostart(R) XL PVS Systems are indicated for the percutaneous deliveyr of sutures for closing the common femoral artery access site and reducing hte time to hemostasis and ambulation (patient walks ten feet) of patients who have undegone catheterization procedures using 6.5 French to 10 French sheaths.
P850070|S010|AUTOMATIC LIQUID PACKAGING, INC.|2200 W. LAKE SHORE DR.||WOODSTOCK|IL|60098||Accessories, soft lens products|STERILE SALINE PRESERVED SOLUTION|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/1997|07/02/1997|||APPR|APPROVAL TO ELIMINATE ETHYLENE OXIDE STERILIZATION OF THE FLIP-TOP PIERCING CAP ATTACHED TO SEALED 12 OZ. AND 16 OZ. CONTAINERS OF STERILE PRESERVED SALINE SOLUTION.
P880003|S069|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CHARGER PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/1997|07/18/1997|||APPR|Approval for the Cordis Charger(TM) family of PTCA Dilatation Catheters.
P880027|S050|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BONNIE (TM) PTCA CATHERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/1997|10/24/1997|||APPR|Approval for 15 mm length models of the Bonnie(TM) PTCA Catheter.  The new models will be marketed under the trade name Bonnie(TM) Monorail(R) Percutaneous Transluminal Coronary Agnioplasty (PTCA) Catheters and are indicated for balloon dilatation of the stenotic portion of a coronary arteyr or bypass graft stenosis for the purpose of improving myocardial perfusion.
P910020|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|EDGEBAND PACER RELAY MODEL 294-03E|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/1997|11/18/1997|||APPR|Approval for the Relay Model 294-03E edgeband pulse generator.
P910061|S001|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL LI51U & LI61U SOFLEX UV-ABSORBING SILICONE PC IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/1997|10/21/1997|||APPR|Approval for the Models LI51U and LI61U IOLs.
P820001|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Accessories, soft lens products|OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER|LPN|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/1997|07/03/1997|||APPR|Approval for a 1.5ml fill volume in the same container as the currently approved 3.0ml fill size.
P860027|S012|CARDIAC CONTROL SYSTEMS, INC.|3 COMMERCE BLVD.||PALM COAST|FL|32164||Implantable pulse generator, pacemaker (non-CRT)|MAESTRO(R) II MODEL 534 PACEMAKER SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/12/1997|07/29/1997|||APPR|APPROVAL FOR THE MAESTRO II MODEL 534 PACEMAKER SYSTEM.
N17004|S009|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/16/1997|08/08/1997|||APPR|APPROVAL FOR ALTERNATIVE SUPPLIER OF METHYL METHACRYLATE MONOMER.
P860019|S123|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED NC BIB RANGER PTCA CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/16/1997|07/15/1997|||APPR|Approval for the SCIMED(R) NC BIG Ranger(TM) PTCA Catheter.
P860019|S124|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1997|07/15/1997|||APPR|Approval for a change from 1 to 2 marker bands for the 20 mm balloon length Ranger(TM) PTCA Catheter and for a change that makes all Ranger(TM) PTCA Catheter (20, 30, and 40 mm balloon lengths) marker band locations proximal and distal.
P860019|S125|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1997|08/12/1997|||APPR|APPROVAL FOR ADDITIONAL BALLOON SIZES (2.75 MM, 3.25 MM, AND 3.75 MM) FOR THE SCIMED(R) 15 MM AND 20 MM QUANTUM RANGER(TM) PTCA CATHETER.
P950002|S004|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK INTERBODY FUSION SYSTEM|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/1997|06/30/1997|||APPR|APPROVAL OF DESIGN CHANGES TO THE INSERTION END OF THE POLYETHYLENE ENDCAP AND THE INSERTION TOOLS USED AS PART OF THE BAK INTERBODY FUSION SYSTEM.
P870018|S017|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR MULTILINE|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1997|08/26/1998|||APRL|Approval for a new configuration of the Lithostar(R).  The device, as modified, will be marketed under the trade name Lithostar(R) Multiline and is indicated for use in patients with renal and upper ureteral caculi between 5mm and 15mm.
P930038|S006|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/1997|07/28/1997|||APPR|APPROVAL FOR EXPANDING THE RANGE OF THE DEVICE USERS TO INCLUDE HEALTH CARE PROFESSIONALS OTHER THAN PHYSICIANS.
P900023|S023|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1997|09/03/1997|||APPR|Approval for use of a 42 French atrial and a 42 French arterial cannula to be used with the BVS 5000(R) Bi-Ventricular Support System.
P810046|S179|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ROCKET TM AND ACS AVENGER CORONARY DILATATION CAHTETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1997|11/07/1997|||APPR|Approval for the ACS RX Rocket(TM) and ACS Avenger(TM) Coronary Dilatation Catheters.  The device is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for ht epurpose of improving myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with S-T segment elevation myocardial infarction.
P790019|S010|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|ABBOTT IMX(R) HAVAB(R)-M|LOL|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/20/1997|07/24/1997|||APPR|APPROVAL FOR A CHANGE IN THE EVALUATION OF THE HAVAB-M EIA CONJUGATE CONCENTRATE, POSITIVE CONTROL FROM A SAMPLE TO STANDARD RATIO TO A SAMPLE TO TARGET RATIO.
P950043|S001|MEDISPEC, LTD.|19110 MONTGOMERY VILLAGE AVE.|SUITE 100|MONTGOMERY VILLAGE|MD|20886||Lithotriptor, extracorporeal shock-wave,urological|ECONOLITH(TM) LITHOTRIPTER|LNS|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/1997|06/30/1997|||APRL|APPROVAL FOR A TRANSPORTABLE VERSION OF THE ECONOLITH(TM) LITHOTRIPTER.
P930014|S005|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF(R) ACRYLIC POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/1997|10/09/1998|||APPR|Approval for changes to the labeling.
P910023|S029|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/1997|08/12/1997|||APPR|APPROVAL OF ADDITIONAL HEADERS (MODELS V-145 AND V-145B) FOR THE CONTOUR(TM) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM.
P890055|S004|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1997|03/17/1998|||APPR|Approval for the Arrow Model 3000-16 Constant Flow Implantable Pump with Bolus Safety Valve for adult use for the following indications: 1)the intraspinal delivery of preservative free morphine for patients with intractable chronic pain, 2)the intraspinal delivery of preservative free morphine for the treatment of pain of malignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5-fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.
P910020|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|MOMENTUM PACERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/23/1997|07/29/1997|||APPR|APPROVAL FOR THE MOMENTUM PULSE GENERATOR MODELS 294-23, 294-23Z, AND 293-23 WITH RX5000 PROGRAMMER MODEL 522-12 WITH MARATHON APPLICATION SOFTWARE VERSION 3.00
P950027|S001|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN(R)|MOZ|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/1997|07/08/1997|||APPR|APPROVAL FOR THE U.S. DISTRIBUTOR, SANOFI PHARMACEUTICALS, INC., NEW YORK, NEW YORK.  ADDITIONALLY, WE HAVE REVIEWED THE EDITORIAL CHANGES YOU PROPOSE FOR THE LABELING FOR YOUR PRODUCT AND HAVE DETERMINED THAT THEY ARE APPROPRIATE.
P940002|S002|SULZERMEDICA|9900 SPECTRUM DR.||AUSTIN,|TX|78717||PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NATURAL-KNEE(R) WITH CSTI(TM)|MBD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1997|10/16/1997|||APPR|Approval for another sterilization site located at SteriGenics International, 3125 Wichita Court, Forth Worth, Texas 76140.
P890003|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|PREVA, PRODIGY, VITATRON AND THERA PACEMAKERS|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/1997|11/18/1997|||APPR|Approval for cell phone labeling for the Prevail, Preva, Prodigy, Thera-i, and Vitatron pacemakers.
P850051|S054|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|PREVAIL PACEMAKERS|LWO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/1997|11/18/1997|||APPR|Approval for cell phone labeling for the Prevail, Preva, Prodigy, Thera-i, and Vitatron pacemakers.
P880098|S010|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lenses, soft contact, extended wear|MENICON SF-P (MELAFOCON A) CONTACT LENS|LPM|OP|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/30/1997|08/25/1997|||APPR|Approval for an alternate packaging process where Barnes Hind(R) Comfort Care(R) GP Wetting and Soaking Solution is added to the lens shipping case.  Lenses will be shipped wet with a storage period of up to 30 days from the date of hydration.
P820049|S064|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODELS PC-58NBM & PC-58NBZ IOLS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1997|10/02/1997|||APPR|Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salina, Puerto Rico.
P890056|S005|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||intraocular lens|MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1997|10/02/1997|||APPR|Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, Puerto Rico.
P860034|S015|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1997|10/02/1997|||APPR|Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, Puerto Rico.
P880081|S023|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1997|10/02/1997|||APPR|Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, Puerto Rico.
P900030|S006|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN BARD COLLAGEN IMPLANT|LNM|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/1997|07/11/1997|||APPR|Approval for a labeling change.
P900033|S002|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||Dressing, wound and burn, interactive|INTEGRA (ARTIFICIAL SKIN)|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/1997|08/07/1997|||APPR|APPROVAL FOR A 24 MONTH EXPIRATION DATE FOR INTEGRA ARTIFICIAL SKIN.
P810046|S180|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX COMET CORONARY DILATATION CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/1997|08/12/1997|||APPR|APPROVAL FOR MODIFICATION TO THE INSTRUCTIONS FOR USE.
P890027|S039|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/1997|12/28/1997|||APPR|Approval for expansion ofthe indication for use of hte Nucleus 22 Channel Cochlear Implant to include children 18 months and older.
P950040|S003|PERSONAL HEALTH & HYGIENE, INC.|2 NORTH CHARLES STREE||BALTIMORE|MD|21201||ENZYME IMMUNOASSAY, CANNABINOIDS|DR. BROWN'S HOME DRUG TESTING KIT|LDJ|TX|||N|06/10/1997|08/15/1997|||APPR|Approval for labeling of your device in final printed form and for a change in the group providing phone services related to your device from Joseph J. Sheerin to National Medical Review Officers, Inc.
P940034|S005|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|MWA|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/1997|01/07/1998|||APPR|Approval for Physician Prescribing Information to be considered a component of the labeling for MTD.  At this time there are no provisions for "in vitro" device labeling other than prescribed 21 CFR 809.10 (b); however, the Physician Prescribing Information may be used as promotional and advertising material.
P920014|S007|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE(R) VE LVAS|DSQ|CV|Panel Track|Change Design/Components/Specifications/Material|N|07/02/1997|09/29/1998|99M-1520|06/09/1999|APPR|approval for the HeartMate(R) VE LVAS.  This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure.  The HeartMate(R) VE LVAS is indicated for use both inside and outside the hospital.
P860019|S126|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/1997|08/12/1997|||APPR|APPROVAL FOR ADDITIONAL BALLOON SIZES (22 MM AND 30 MM LENGTHS WITH  BALLOON SIZES OF 2.5 MM UP TO 4.0 MM IN 1/4 SIZES) FOR THE SCIMED(R) QUANTUM RANGER(TM) PTCA CATHETER.
P890057|S010|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/03/1997|06/15/1998|||APPR|Approval for changes to the oscillating mechanism and an increased range of continuous flow.
N18033|S031|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)|LPM|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/03/1997|07/11/1997|||APPR|Approval for changes in the Package Insert and Fitting and Patient Management Guide pertaining to the ACUVUE(R) BIFOCAL (etafilcon A) Contact Lens.  The changes are designed to enhance practitioners' fitting performance and early visual success of the patient.  No changes are made tot he remaining portions of approved labeling.
P940022|S003|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342|||CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) S-SERIES TM SPEECH PROCESSOR||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1997|09/05/1997|||APPR|Approval for the S-Series Speech Processor.
P960058|S001|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/1997|09/05/1997|||APPR|Approval for the S-Series(TM) Speech Processor.
P880064|S002|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||Applicator, hyperthermia, superficial, rf/microwave|HYPERTHERMIA SYSTEM 100 A|LNC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/15/1997|09/17/1997|||APPR|Approval for a design change to enhance the heat focusing capabilities of the Microfocus 1000 Hyperthermia System.
P890043|S032|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM|MCX|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/1997|06/08/1998|||APPR|Approval for a change in the biological indicator incubation time from 7 to 5 days.
P880003|S071|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS TITAN & TITAL XL DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/17/1997|08/04/1998|||APPR|Approval for a new indication for use:  the post-delivery expansion of the Palmaz-Schatz(TM) Coronary Stet, with the Titan(TM) and Tita(TM) XL PTCA Dilatation Catheters (3.0 mm, 3.25 mm, 3.5mm, 3.75 mm balloon diamters with 9 mm and 18 mm balloon lengths, and a 4.0 mm balloon diameter with 9 mm balloon length.)
P860019|S128|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1997|09/30/1997|||APPR|
P900043|S007|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1997|12/19/1997|||APPR|Approval for the Palmaz-Schatz(TM) Crown balloon expandable stent in diameters of 3.0, 3.5, and 4.0 mm and lengths of 15, 22 and 30 mm.  In addition approval for primary stenting of de novo lesions up to 25 mm in length and other modifications to the current label.
P790017|S063|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|PROCROSS RELY SP PTCA CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/31/1997|08/26/1997|||APPR|Approval for the addition of ten models to your currently marketed line of USCI(R) ProCross(TM) Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel(R) Coating.  The device, as modified, will be marketed under the trade name USCI(R) ProCross(TM) SP Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel(R) Coating and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P790018|S031|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1997|11/24/1997|||APPR|Approval for a modification to the controlled environment area for certain manufacturing steps.
P920015|S013|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6943 AND 6945|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/1997|09/10/1997|||APPR|Approval for Medtronic(R) Sprint(TM) Models 6943 and 6945 leads.
P910077|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/1997|08/08/1997|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).
P840068|S033|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/1997|08/08/1997|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).
P940031|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VIGOR(R) DR/SR PACEMAKER SYSTEM||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/1997|08/08/1997|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).
P840001|S041|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/1997|01/20/1998|||APPR|Approval for the use of an alternative packaging material, uncoated PETG (polyethylene terephthalate, glycol modifed) for the manufacture of the inner and outer packaging trays.  The device, as modified, will be marketed under the trade name Itrel and is indicated for Spinal Cord Stimulation.
P930016|S005|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX EXCIMER LASER SYSTEM MODELS B AND C|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|07/23/1997|01/29/1998|99M-0293|07/15/1999|APPR|Approval for the VISX Excimer Laser System (Models B and C).  This device is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0 mm major axis.  The PRK procedure is intended for use:  1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2) in patients 18-20 years of age in PRK treatments for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0 D spherical equivelent at the corneal plane with less than or equal to -1.0 D of astigmatism; or 3) in patients 21 years of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0 D spherical myopia at the spectacle plane and up to -4.0 D of astigmatism.
P910077|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/1997|01/23/1998|||APPR|Approval for higher shock energy for the VENTAK MINI HE, the downsized VENTAK MINI III, revisions to the VENTAK MINI Application Software-Model 2840, and labeling revisions ot indicate shock energy as joules "stored" and updating the indications for use.
P940008|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RES-Q(TM) MICRON ICD SYSTEM||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/25/1997|08/13/1997|||APPR|THIS SUPPLEMENT CONTAINS THE CHANGES TO A DOCUMENT THAT WAS ORIGINALLY SUBMITTED WITH THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) SUPPLEMENT APPLICATION G950212/S8.  THE IDE SUPPLEMENT REQUESTED TO CLOSE THE CLINICAL INVESTIGATION OF RES-Q II ACD DEVICES.  SINCE THE IDE WAS OFFICIALLY CLOSED, FDA RECOMMENDED TO USE THIS PMA SUPPLEMENT AS AN ADMINISTRATIVE VEHICLE TO ADDRESS THE DEAR DOCTOR LETTER THAT WAS PREVIOUSLY SUBMITTED AS PART OF THE IDE SUPPLEMENT.  FDA ACKNOWLEDGES THAT ALTHOUGH THE ABOVE INFORMATION HAS BEEN SUBMITTED AS A SUPPLEMENT TO THIS PMA, THE RES-Q II ACD IS NOT PART OF THE FAMILY OF SULZER INTERMEDICS PMA APPROVED PRODUCTS.  FDA FURTHER ACKNOWLEDGES THAT SULZER INTERMEDICS IS NOT SEEKING COMMERCIAL APPROVAL OF THE RES-Q II ACD DEVICE.  BASED UPON THE INFORMATION SUBMITTED, THE PMA SUPPLEMENT IS APPROVED WITHOUT CONDITIONS.
P810055|S069|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/1998|12/03/1999|||APPR|Approval for the use of UVEX 326 polymethylmethacrylate (PMMA) material in the manufacture of one-piece PMMA posterior chamber intraocular lenses (IOLs) approved under P810055.
P830045|S054|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|APS III MODEL 3500 PROGRAMMER|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/1997|10/07/1997|||APPR|Approval for the APS II Model 3500 Programmer with Mdoel 3302 Software.
P880086|S041|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APS III MODEL 3500 PROGRAMMER|DXY|CV|Normal 180 Day Track||N|07/31/1997|10/07/1997|||APPR|Approval for the APS III Model 3500 Programmer with Model 3302 Software.
P960040|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV AICD TM SYSTEM||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/1997|08/08/1997|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).
P950014|S007|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/1997|10/27/1997|||APPR|Approval for a single-module version of the Prostatron, as well as minor hardware and software changes to both the single and dual-module Prostatron versions.
P930038|S007|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/1997|02/02/1998|||APPR|Approval for modifications to the tamper tube component of the Angio-Seal(TM) Hemostatic Puncture Closure Device.
N16895|S085|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS (POLYMACON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1997|10/15/1997|||APPR|Approval for labeling modifications: 1) combination of the separate package insert and professional fitting guide into a single package insert and fitting guide; and 2) incorporation of information in the package insert and fitting guide related to prescribing the lenses for frequent replacement and disposable wear, along with separate patient information booklets for disposable and frequent replacement wear.
P960022|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS66(TM)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/1997|09/30/1997|||APPR|
P970003|S001|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROTHESIS SYSTEM|LYJ|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1997|08/21/1997|||APPR|Approval for a manufacturing site located at Texcel, Inc., 55 Deer Park Drive, E. Longmeadow, MA  01028.
P920004|S007|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (TM)|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/08/1997|09/15/1997|||APPR|Approval for expanding the range of device users to include health care professionals other than physicians.
P900023|S024|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/1997|09/26/1997|||APPR|Approval for a change in the manufacturing process to allow the coupling nut to be annealed prior to assembly of the blood pump.
P880027|S051|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BONNIE (TM) PTCA CATHERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/1997|10/23/1997|||APPR|Approval for 30 and 40 mm length models of the Bonnie(TM) PTCA Catheter.  The new models will be marketed under the trade name Bonnie(TM) Monorail(R) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters and are indicated for balloon dilatation for the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P880091|S011|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/14/1997|07/20/1998|||APPR|Approval to package the MicroSTAAR injector cartridges with the ELASTIMIDE(TM) lenses, and for a five-year shelf life for the cartridges sterilized via your new ethylene oxide (EtO) cycle.
P920047|S008|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|E P TECH EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/1997|12/18/1997|||APPR|Approval for addition of a new manufacturing facility located at SeaMED Corp., 21621 30th Avenue NE, Bothell, WA  98021.
P890003|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9802 E REVEAL INSERTABLE LOOP RECORDER SOFTWARE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1997|01/29/1998|||APPR|Approval for the Model 9802E Reveal(TM) Insertable Loop Recorder Software for use with the Model 9790/9790C Programmers.
P880091|S012|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1997|04/17/1998|||APPR|Approval for parametric release of lenses sterilized in the previously approved sterilizer.
P950034|S007|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1997|09/11/1997|||APPR|Approval for an alternate manufacturing facility for labeling and packaging located at Deknatel Inc., 600 Airport Road, Fall River, MA.
P930012|S008|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|CHAMPION WRAP PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/1997|02/02/1998|||APPR|Approval for:  1) a line of Champion(TM) HP PTCA Catheters packaged with the Wrap(TM) Sheathing System; 2) the additionof quarter-sized balloons to this line of catheters extending the balloon diameter limits from 3.0-4.0 mm to 2.5-4.5mm; and 3) a revised package insert which streamlines the Instructions for Use and compresses the previous package inserts for the 15 mm and 20 mm long balloons into one combined insert.
P810046|S181|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS TX 2000 VP CORONARY DILATATION CATHETER          CAHTETERS|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/1997|11/26/1997|||APPR|Approval for the ACS Tx2000VP(TM) coronary dilatation catheter with additional balloon sizes 2.75, 3.25, and 3.75 x 15 mm and 20 mm.
P900056|S021|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/1997|12/19/1997|||APPR|Approval for an alternate manufacturing facility located at SeaMED Corporation, 21621 30TH Avenue NE, Bothell, WA 98021.
P850007|S020|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/1997|03/09/2000|||APPR|Approval to modify the device labeling to include Patient Registry data in addition to the original data contained in the PMA
P960031|S001|XYTRONYX, INC.|6730 MESA RIDGE RD. SUITE A||SAN DIEGO|CA|92121|||PERIOGARD PERIODONTAL TISSUE MONITOR||CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1997|09/30/1997|||APPR|
P970008|S001|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1997|08/28/1997|||APPR|Approval for a change in trade name.  The device will be marketed under the trade anme Urologix Targis(TM) system and is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) in ment with prostatic lengths of 30 to 50 millimeters.
P860005|S008|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)|MBS|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1997|09/11/1997|||APPR|Approval for a new sterilization site located at Isomedix Operations, Inc., Sand Utah Division, 9120 South 150 East, Sandy, UT.
P950014|S008|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1997|11/07/1997|||APPR|Approval for a new sterilization facility located at Griffith Micro Science, 8 rue de Parmentier, 60290 Rantigny, France.
P910071|S004|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL 5000|LWL|OP|Normal 180 Day Track|Other Report|N|07/08/1997|12/24/1997|||APPR|Requested that a Phase IV trial of AdatoSil 5000(TM) no longer be required as a condition of approval for this PMA, and that the current labeling be revised to state more specificaly the role of the physician in determining the use and removal of AdatoSil 5000(TM) silicone oil.
P970008|S002|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIC TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/1997|01/09/1998|||APPR|Approval for a new manufacturing facility located at SeaMED Corp., 21621 30th ave., NE, Bothell, WA  98021.
P970003|S002|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROTHESIS SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/1997|10/09/1997|||APPR|Approval for the modified NCP(R) System Lead Connector Boot Design and the NCP(R) System Programming Software Version 4.1.
P970003|S003|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROTHESIS SYSTEM|LYJ|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/1997|11/21/1997|||APPR|Approval for the Model 250 NCP Software Version 5.0 modification.
P970003|S004|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROTHESIS SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/18/1997|01/29/1998|||APPR|Approval for NCP(R) Model 100C Pulse Generator with modifications to the microcontroller and battery.  The device, as modified, will be marketed under the trade name NCP(R) Model 100C Pulse Generator ans is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with pertial onset seizures, which are refractory to anti-epileptic medications.
P970003|S005|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROTHESIS SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/1997|10/09/1997|||APPR|Approval for the modified NCP(R) System Lead Connector Boot Design and the NCP(R) System Programming Software Version 4.1.
P910023|S030|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/08/1997|02/02/1998|||APPR|Approval for the Contour(TM) II/Angstrom(TM) II IMplantable Cardioverter/Defibrillator (ICD) System (Contour(TM) II ICD Models V-185, V-185B, V-185C, V-185D and V-185AC, Angstrom(TM) II ICD Models V-180F and V-180HV3, Torque Drive Model AC-TD, DF-1 Receptacle Plug Model AC-DP and PRogrammer Software Version 5.1), a modification to Programmer Software Version 5.1 to allow use with the Ventritex(R) Programmer Model PR-1500, use of the Contour(TM) II and Angstrom(TM) II pulse generator with the Medtronic(R) Transvene(R) Leads, changes in the Contour(TM) II/Angstrom(TM) II Labeling and modifications to PRogrammer Software Version 5.1 to improve the ECG display and theaccuracy of the reported data.
P800036|S034|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/1997|12/19/1997|||APPR|Approval for the use of Arrow 22 gauge non-coring (hubber) needles (Catalog #s AP-04009, AP-04011, and AP-04030) to access Infusaid Model 400 infusion pumps.
P890055|S005|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|FLEX TIP INTRASPINAL KIT, CATALOG AP-07008|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/1997|12/23/1998|||APPR|Approval for the Flex tip Plus Intraspinal Catheter Kit, Catalog AP-07008.  This Catheter Kit will be used with the model 3000 Implantable Pump with Bolus Safety Valve for intraspinal delivery of preservative free morphine to patients with chronic intractable pain.
P880027|S052|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BONNIE (TM) PTCA CATHERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/1997|08/27/1998|||APPR|Approval for a new PTCA catheter.  The device, as modified, will be marketed under the trade name Bypass Speedy(TM) Monorail(R) PTCA Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpsoe of improving myocardial perfusion.
P900070|S020|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|MODEL 1256D META MV CARDIAC PULSE GENERATOR|DXY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/10/1997|10/07/1997|||APPR|Approval for the change in companies from Telectronics to Pacesetter.  The device, as modified, will be marketed under the brand name Pacesetter for the dual chamber pacing models of the META(TM) DDDR Model 1250H Pulse Generator (hereinafter referred to as the META(TM) DDDR) which is indicated where maintenance of atrio-ventricular synchrony is required.  This requirement is associated with the generally accepted indication for permanaent cardiac pacing which includes, but are not limited to: 1) sick sinus node syndorme; 2)symptomatic bradycardia; 3)symptomatic A-V block; 4)recurrent Stokes-Adams syndrome; 5)carotid sinus syncope; and 6)suppression of tachycardia.
P860003|S029|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHORESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1997|02/26/1998|||APPR|Approval for Griffith Micro Science in Glens Falls, New York, to serve as the contract sterilization facility for th esterilization of the TK001 Photopheresis Procedural Kit, which is validated utilizing a biological indicator system internal to the product.
P910023|S031|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/12/1997|11/05/1997|||APPR|Approval of the Ventritex Cadence(R) and Cadet(R) with the Medtronic Transvene(R) defibrillation leads.
P940034|S006|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121|||GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)||MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/1997|10/30/1997|||APPR|Approval for manufacturing facility relocation to 10210 Genetic Center Dr., San Diego, CA.
P860022|S048|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|IPAFLUOROFOCON A AND B|HQD|OP|Normal 180 Day Track|Other Report|N|09/16/1997|10/15/1997|||APPR|Approval for the five additional finishing laboratories listed in the enclosure to become additional manufacturers and distributors of the contact lenses.  FDA also acknowledges your notification of a new adopted USAN name for EQUALENS II (oprifocon A).
P950014|S009|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/1997|09/24/1997|||APPR|Approval for the following changes in intended to minimize the risk of Prostaprobe balloon deflation difficulty:  1)modification of the Prostaprobe manufacturing procedures, and 2) addition of a labeling precaution.
P870015|S026|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/1997|09/29/1997|||APRL|
P840040|S051|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROOVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/1997|11/21/1997|||APPR|Approval for a change in adhesive.
P960013|S001|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/1997|03/19/1998|||APPR|Approval for the use of Thermedics Tecothane T11075D-M for molded polyurethane components as a replacement for Pellethane 2363-75D.  FDA also acknowledges your marketing of the Tenril DX Model 1388T/C lead, which is identical to the approved Model 1388t lead, except that it is packaged only with the clip-on tool accessory.
P860019|S129|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/25/1997|08/20/1998|||APPR|Approval for a new indication for the SCIMED(R) NC Ranger and NC Rebel PTCA Catheters.  The new indication is post-delivery expansion of balloon expandable stents.
P840024|S071|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/1997|06/26/1998|||APPR|Approval for anew sterilization facility located at cochlear limited, 14 mars road, lane cove, new south wales 2066, australia.
P890027|S040|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/1997|06/26/1998|||APPR|Approval for a New Sterilizatin facility located at Cochlear Limited, 14 Mars Road, Lane Cove, New South Wales 2066, Australia.
P960028|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|||N|09/19/1997|10/07/1997|||APPR|Approval to modify the current maximum level of ethylene ixide residual from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."
P860019|S130|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/24/1997|10/31/1997|||APPR|Approval for additional balloon sizes (22, 25, and 30 mm balloon lengths with balloon diameters ranging from 2.5 to 4.0 mm in 0.25 mm increments) for the NC Ranger(TM) PTCA Catheter.
P900070|S021|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|TEMPO PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/1997|10/16/1997|||APPR|Approval for an alternate manufacturing facility located at Pacesetter, Inc., St. Jude Medical cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar CA.
P890055|S006|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/1997|09/15/1998|||APPR|Approval for the addition of Lioresal Intrathecal (baclofen injection) to the list of drugs approved for use with the M-3000 Implantable Drug Delivery Pump With Bolus Safety Valve.
P910007|S005|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ABBOTT AXSYM TOTAL PSA|LTJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|09/25/1997|02/02/2004|||APPR|APPROVAL FOR THE ABBOTT AXSYM TOTAL PSA ASSAY.  THE AXSY TOTAL PSA IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE DETERMINATION OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1 ANTICHYMOTRYPSIN) IN HUMAN SERUM:  1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.  2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
P960040|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV AICD TM SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1997|12/09/1997|||APPR|Approval for the VENTAK(R) AV II pulse generator Models 1820 and 1825, Model 2833 Application Software, Version 2.8 and revised labeling to include shock energy as Joules "stored" rather than Joules "delivered".
P930035|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/1997|12/15/1997|||APPR|Approval for the VENTAK(R) AV II pulse generator Models 1820 and 1825, Model 2833 Application Software, Version 2,8 and revised labeling to include shock energy as Joules "stored" rahter than Joules "delivered".
P890064|S006|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1997|03/17/1999|||APPR|Approval for chaning the solid phase on which the RNA:DNA hybrids are captured from polystyrene tubes to a 96-well microtiter place addition of a new cervical specimen collection kit (Digene Cervical Sampler), addition of the Digene Sample Conversion Kit,a nd the addition of new assay performance characteristics.  The device, as modified, will be marketed under the trade name Digene HPV Test Using Hybrid Capture(R) II Technology (HCII HPV) witht he following indications:  The Digene HPV Test using Hybrid Capture II technology is a nucleic acid signal enhanced solution hybridization microplate assay using chemiluminescence for the qualitative detection of eighteen types of human papillomavirus (HPV) DNA in cervical specimens.  The Digene HPV Test can differentiate between two HPV DNA groups: low risk HPV types 6/11/42/43/44; and high/intermediate risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68, but cannot determine the specific HPV type present.  Cervical specimens which may be tested with the Digene HPV Test include the following: 1) Specimens collected with the Digene Cervical Sampler; 2) Biopsies collected in the Digene Specimen Transport Medium; 3) Specimens collected using a broom-type collection device and placed in Cytye PreservCyt Solution (refer to the Digen Sample Converstion Kit package insert for complete details).
P950001|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE PICOTIP STEROID ELUTING LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/1997|04/08/1998|||APPR|Approval for:  a) Selute(R) Picotip(TM) Steroid Eluting, Endocardial Pacing Lead Model 4030, 4031, 4032, 4033, 4034, and 4035 which are indicated for chronic pacing and asensing of the ventricle when used with a compatible pulse generator, and b) the use of the Cosmed of Illinois facility as an alternate sterilization site.
P950014|S010|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/1997|10/07/1997|||APPR|Approval for a transmobile version fothe Prostatron (dual module version).
P960043|S003|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/1997|11/18/1997|||APPR|Approval for changes tot he Precautions and Clinical Procedure sections of the Instructions for Use.
P840024|S072|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1997|06/26/1998|||APPR|Approval for modifications to your device to allow the patient to undergo Magnetic Resonance Imaging (MRI).
P890027|S041|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1997|06/26/1998|||APPR|Approval for modifications to your device to allow the patient to undergo Magnetic Resonance Imaging (MRI).
P860019|S131|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1997|06/29/1998|||APPR|Approval for a modification of the SCIMED Ranger(TM) PTCA Catheter, with the primary difference being use of a new balloon material.  The device, as modified, will be marketed under the trade name SCIMED(R) COYOTE(TM) Percutaneous Transluminal Angioplasty Coronary (PTCA) Catheter and is indicated for the balloon dilatation of coronary arteries or bypass graft stenoses for the prupose of improving myhocardial perfusion and (balloon models 2.5-4.0 mm only) the post-delivery expansion of balloon expandable stents.
P870015|S027|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) LITHOTRIPTER|LNS|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/1997|10/31/1997|||APRL|Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
N50510|S078|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/1997|12/08/1997|||APPR|Approvalf or the removal of the disclaimer for Ticarcillin/Clavulanic Acid when testing Pseudomonas aeruginosa.
P870072|S005|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/1997|05/21/1998|99M-1521|06/09/1999|APPR|Approval for the Thoratec(R) Ventricular Assist Device (VAD) System.  This device is now also indicated for post-cardiotomy patients who are unable to be weaned from cardiopulmonary bypass.
P920051|S007|KARL STORZ ENDOSCOPY-AMERICA, INC.|1201 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER        VERSION)                                     ANSPORTABLE VERSION)|LNS|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/1997|10/31/1997|||APRL|Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
P910031|S017|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/14/1997|11/10/1997|||APPR|Approval for a change in the trade name from the LYNX(TM) to the Guardian(TM) Coronary Balloon Dilatation PTCA Catheter.
P850089|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/10/1997|11/21/1997|||APPR|Approval for a change in connector design for the Model 5023M pacing lead.
P860019|S132|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/1997|12/08/1997|||APPR|Approval for an additional balloon length of 25 mm with balloon sizes of 2.5 mm up to 4.0 mm in 1/4 sizes for the SCIMED(R) NC REBEL(TM) PTCA Catheter.
P960044|S001|MILLENIUM MEDICAL SUPPLY, INC.|THE WILLARD OFFICE BLDG.|1455 PENNSYLVANIA AVE., N.W.|WASHINGTON, D.C.   20004|DC|20004||Device, needle destruction|NEEDLE-EASE MODEL 3500|MTV|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/1997|02/11/1998|||APPR|Approval for a modified needle destruction device.  The device, as modified, will be marketed under the trade name Needle-Ease(R) 3500 and is indicated for the disposal of standard plstic syringe-mounted hypodermic needles and aluminum hubbed dental needles in doctor's and dentist's offices.
P910073|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/1997|11/17/1997|||APPR|Approval for changes to the IS-1 terminal of the DSP lead.
P860019|S133|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED BANDIT AND RANGER PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/1997|10/31/1997|||APPR|Additional manufacturing site located at Boston Scientific Ireland and the sterilization facility at Isotron Ireland, Ltd.
P820060|S012|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AXSYM AFP|LOJ|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/15/1997|10/29/1997|||APPR|Approval for changes in the labeling regarding limitations of the procedure
P920047|S009|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|E P TECH EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1997|04/06/1998|||APPR|Approval for design modifications that provide for new circuitry to an accessory of the system (Automatic Personality Module) which permits filtering of electrograms during ablation.
P840008|S061|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/1997|11/03/1997|||APRL|Approval to offer the Dornier X-ray Imaging Module, the Extended Image Stoarage component, and an alterantive electrocardiogram monitor as options ofor your device.  In addition, the Advance Technology Laboratories ultrasound system will no longer be an option on your device.  Finall, the wording of your precaution on hypertension has been modified as requested by FDA after our review of your postapproval study results.
P860019|S134|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/1997|12/08/1997|||APPR|Approval for an additional balloon length of 25 mm with balloon sizes fo 2.5 mm up to 4.0 mm in 1/4 sizes for the SCIMED(R) Quantum Ranger(TM) PTCA Catheter.
P960007|S003|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT-TC(TM)|MGR|SU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|10/22/1997|11/24/1997|||APPR|Approval for a change of Dermagraft-TC storage conditions to include -20C frost-free freezers.
P970008|S003|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIC TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/1997|10/28/1997|||APPR|Approval for the addition of a capacitor to the circuitry leading to each of the five sensors withing the rectal thermosensing unit (RTU) of the Targis(TM) System to improve the accuracy of the RTU temperature readings.
P930038|S009|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/1997|11/17/1997|||APPR|Approval for changes to the Information Card and Patient Brochure.
P940031|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/1997|04/30/1998|||APPR|Approval for the addition of the MERIDIAN(TM) and DISCOVER(TM) Pacemaker Systems to the current VIGOR family of pacemakers.  The device, as modified, will be marketed under the trade name MERIDIAN(TM) and DISCOVERY(TM) Pacemaker Systems and is generally indicated for long-term cardiac pacing.  Generally accepted indications for long-term cardiac pacing include, but are not limited to, sick sinus syndrome; chronic sinus arrhythmias, including sinus bradycardia, sinus arrest, and sinoatrial (SA) block; second-and third-degree atrioventricular (AV) block; bradycardia-tachycardia syndrome; and carotid sinus syndrome.  Patients who demonstrate hemodynamic improvement from atrioventricular synchrony should be considered for one ofthe dual-chamber or atrial pacing modes.  Dual-chamber modes are specifically indicated for treatment of atrioventricular synchrony, including varying degrees of AV block; low cardiac output or congestive heart failure related to bradycardia; and certain tachyarrhythmias.  Teh adaptive-rate pacing modes of the pacemaker are indicated for patients exhibiting chronotropic incompetence and who would benefit by increase pacing rates concurrent with elevated metabolic demand.
P960028|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/1997|12/30/1997|||APPR|Approval for the addition of an alternate manufacturing site, A.M.O. Puerto Rico, Inc., and an alternate sterilization site, Steri-Tech, Inc.
P970004|S001|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM|EZW|GU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1997|10/31/1997|||APPR|Approval for the Medtronic(R) Model 041826 Self-Adhesive Ground Pad Bulk Accessory.
P960007|S004|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT-TC(TM)|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/1997|05/12/1998|||APPR|Approval for the new product label and directions for use for the new indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
N17004|S010|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/1997|11/13/1997|||APPR|Approval for the elimination of a series of duplicative tests that are performed on the Surgical Simplex(R) P Bone Cement.
P880027|S053|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BONNIE SLIDING RAIL PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/1997|11/21/1997|||APPR|Approval for a 3 and 1/2 year shelf life for the Bonnie(TM) Slidng Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.
P800036|S035|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/1997|12/19/1997|||APPR|Approval for packaging and sterilizing the Arrow 22 gauge non-coring needle inside the Strato/Infusaid Refill Kit (#103381) in addition to the individually packaged sterile needle configuration.
P860005|S009|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES|MBS|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/27/1997|04/28/1998|||APPR|Approval for several labeling changes as identified and agreed upon in an April 17, 1998 facsimile of the labeling.  The device name will also be modified and will be marketed under the trade name "Pro Osteon(R) Implant 500 Porous Hydroxyapatite Bone Graft Substitute Blocks and Granules."  The device is indicated for the repair of metaphyseal fracture defects and long bone cyst and tumor defects.  For metaphyseal fracture defects, the device is indicated for treatment which occurs within one month of fracture.  The device is to be used in conjunction with rigid internal fixation as dictated by the clinical use requirements in skeletally mature individuals.
P940008|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RES-Q(TM) MICRON ICD SYSTEM||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/29/1997|11/21/1997|||APPR|Approval for an alternate battery.
P940008|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RES-Q(TM) MICRON ICD SYSTEM||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/26/1997|12/29/1997|||APPR|Approval for a design change to the IS-1 connector of the existing defibrillation/pacing leads.
P880011|S009|EDAP INTERNATIONAL CORP.|TWO BURLINGTON WOODS||BURLINGTON|MA|01803||Lithotriptor, extracorporeal shock-wave,urological|SONOLITH 3000 LITHOTRIPTER|LNS|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/29/1997|11/06/1997|||APRL|Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
P910019|S003|INTENSIVE TECHNOLOGY, INC.|3574 RUFFIN RD.||SAN DIEGO|CA|92123||CATHETER, CORONARY, ATHERECTOMY|IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1997|01/29/1998|N||APPR|Approval for a change to the 5.5F TEC(R) cutter catheter, involving an increase in the skirt length of the cutter component from 0.079 inches to 0.104 inches.
P960007|S005|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT-TC(TM)|MGR|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1997|02/12/1998|||APPR|Approval for a change in manufacturing to automate the cell expansion process used to prepare the fibroblast cells for inoculation into the Dermagraft-TC growth system.
P910019|S004|INTENSIVE TECHNOLOGY, INC.|3574 RUFFIN RD.||SAN DIEGO|CA|92123||CATHETER, CORONARY, ATHERECTOMY|IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/30/1997|12/30/1998|||APPR|Approval for a change to the TEC System Power Pack circuitry involving the replacement of the current analog motor control circuitry (integrated circuit, LM1014N-2) with new digital circuitry (integrated circuit microcontroller, PIC16C711).
P850089|S038|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/1997|06/01/1998|||APPR|Approval for the addition of four transvenous leads to the CapSure(R) product line.  The device, will be marketed under the trade names CapSure(R) Z Novus Models 5054 and 5554 and CapSure(R) SP Novus Models 5092 and 5592 and are indicated for pacing and sensing in the atrium or ventricle where implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated.
P930029|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1997|12/18/1997|||APPR|Approval to implement design changes in the RF Performr catheter that will result in the ability of the catheter to deflect in two directions rather than one and the inclusion of a self reference electrode on some models.  The device, as modified, will be marketed under the trade name the RF Conductr MC Self-Reference Catheters and is indicated for the interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia, for the treatment of AV nodal re-entrant tachycardia, and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.
P960040|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV II DR AICD||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1997|03/13/1998|||APPR|Approval for the VENTAK(R) AV(TM) II DR pulse generator Models 1821 and 1826, Model 2843 Application Software, Version 1.3 and revisions to the Physician's Manual, Package Labeling and Patient's Manual.
P970019|S001|HEALTH TRONICS SURGICAL SERVICES, INC.|425 FRANKLIN RD., SUITE 545||MARIETTA|GA|30067||Lithotriptor, extracorporeal shock-wave,urological|HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/05/1997|11/10/1997|||APRL|Approval to offer the HealthTronics LithoTron(TM) Lithotripsy System in both a mobile and transportable version.
P860019|S135|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/1997|12/22/1997|||APPR|Approval for: 1)the addition of balloon diameters of 4.5 mm and 5.0 mm to the currently approved 15 mm length of the NC REBEL(TM) PTCA Catheter, and 2) an additional balloon length of 30 mm with balloon diameters of 2.5 mm up to 4.0 mm in 1/4 mm increments for the NC REBEL(TM) PTCA Catheter.
P900056|S022|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTAWIRE FLOPPY GOLD GUIDE WIRE/ROTABLATOR SYSTEMS GUIDE WIRE LINE|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/1997|08/06/1998|||APPR|Approval for the RotaWire(TM) Floppy Gold Guide Wire for use with the Rotablator(R) Rotational Angioplasty System.
P950005|S001|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/10/1997|05/07/1998|||APPR|Approval for the 6 Fr and 7 Fr Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters - Thermistor and Non-Temperature Sensing Model and Interface Cables used with the EP Technologies 1000 RF Generator.
P920004|S008|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL ES  DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/1997|12/11/1998|||APPR|Approval to market a modified version of the VasoSeal(R) Vascular Hemostasis Device.  The device, as modified, will be marketed under the trade name VasoSeal(R) Extra Security (ES) Device and is indicated for reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography or interventional procedures.
P970008|S004|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIC TARGIS SYSTEM|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/1997|11/26/1997|||APPR|Approval for a change to the physician training manual for the addition of a module for patient comfort management.
P900061|S034|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1997|11/26/1997|||APPR|Approval for the addition of silicone gel over the internal surfaces of the Fast Recovery Diode in the Medtronic(R) Implantable Cardioverter Defibrillator Models 7219, 7220, 7221, and 7223.
P910066|S007|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/1997|04/03/1998|||APPR|Approval for a manufacturing site located at Orthologic Corp., 1275 W. Washington Street, Temple, AZ.
N50510|S079|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/1997|12/08/1997|||APPR|Approval for the removal of the disclaimer for piperacillin when testing Pseudomonas aeruginosa.
P930039|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|SUREFIX TM  MODEL 5072 LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/1997|06/03/1998|||APPR|Approval for the SureFix(TM) Model 5072 Steroid-Eluting Screw-In Pacing Lead with a Non-Retractable Helix.  The device, as modified, will be marketed under the trade name SureFix(TM) Model 5072 Pacing Lead and is designed to be used with a pulse generator as part of a cardiac pacing system.  The lead has application where implantable atrial or ventricular, single chamber or dual chamber pacing systems are indicated.
P860005|S010|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE|MBS|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1997|01/08/1998|||APPR|Approval for a change to the name of the product from "Bone Void Filler" to "Bone Graft Substitute."  The device, as modified in designation, will be marketed under the trade name "Pro Osteon Implant 500 Porous Coralline Hydroxyapatite Bone Graft Substitute Blocks and Granules," and is indicated for the same indications approved in the original PMA and in P860006/S002.
P960009|S001|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Normal 180 Day Track|Other Report|N|11/19/1997|03/27/1998|||APPR|Approval for three of the four conditions of approval, i.e., studies to further characterize long term safety and effectiveness, obtain follow-up mortality and autopsy information, and evaluate patients following implantation of multiple leads and implantation of replacement leads.
P960007|S006|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT-TC(TM)|MGR|SU|Normal 180 Day Track|Other Report|N|11/24/1997|08/05/1999|||APPR|Approval for "A Randomized, Controlled, Within-Patient-Paired Study to Compare the Effectiveness of TransCyte and Biobrane in the Treatment of Mid-Dermal to Indeterminate Depth Burn Wounds."  This study addresses one of the Conditions of Approval in the October 17, 1997 Agency letter for the indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.  The condition was for a postapproval protocol for a multi-center study utilizing a within patient comparison of Dermagraft-TC (TransCyte) to a control treatment for partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.  Included in this submission was to be a sample size justification for the number of patients to be evaluated.  The endpoints of this study were also to include evaluation of infection rates and rate of patients who go on to require autografting.
P900023|S025|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1997|03/13/1998|||APPR|Approval for four new 32 French atrial cannulae which are 90 degrees Bend with Lighthouse Tip, Straight with Lighthouse Tip, 90 degrees Bend with Beveled Tip, and Straight with Beveled Tip.
P960001|S003|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|ENDURANCE BONE CEMENT|LOD|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/1997|01/27/1998|||APPR|Approval for the following changes:  1) to remove ascorbic acid and ethanol from the liquid monomer formulation; and 2) omit the quality control test for dimensional change from the finished product specification.
P930038|S010|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1997|06/03/1998|||APPR|Approval for changes in the Instructions for Use to include a secondary manual tamp during deployment of the device.
P860019|S136|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/1997|07/29/1998|||APPR|Approval for a manufacturing site located at SCIMED Life Systems, Inc., 2 SCIMED Place, Maple Grove, Minnesota 55311.
P960010|S001|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||STENT, CORONARY|MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1997|05/21/1998|||APPR|Approval for the Medtronic Model 6322 Wiktor(R) Rival(TM) Coronary Stent System.  This device is indicated for the treatment of abrupt or threatened closure in patients with failed interventional therapy in native coronary arteries and bypass grafts vessels with reference diameters in the range of 3.0 to 4.5mm.
P860004|S039|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC INDURA 1P ONE PIECE INTRATHECAL CATHETER|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1997|05/21/1998|||APPR|Approval for implementation of the Medtronic(R) InDura(R) 1P One Piece Intrathecal Catheter Model 8709 with your SynchroMed(TM) Infusion System.
P910016|S009|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|LCS(R)TOTAL KNEE SYSTEM|MBD|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1997|01/15/1998|||APPR|Approval for a change to the name of the Unicompartmental Configuration of the new jersey LCS(R) Total Knee System.  This device will now be marketed under the trade name Unicompartmental Configuraiton ofthe LCS(R) Total Knee System and is indicated for uncemented use in patients over 60 years old undergoing unicompartmental knee surgery for rehabilitating knees when only one condyle has been damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis or post-traumatic arthritis.
P830055|S056|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1997|05/14/1998|||APPR|Approval for change to the name of the new jersey LCS(R) Total Knee System.  The system will now be marketed under the trade name LCS(R) Total Knee System.
P960058|S002|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR||EN|Normal 180 Day Track|Other Report|N|11/25/1997|06/22/1998|||APPR|Approval for Postmarket Language study.  A postapproval languate study consisting of 20 to 30 children under age 6 will be undertaken using the Reynell Development Language Scales revised (RDLS).  Data will be collected for 3 years at 6-month intervals.The data analysis will include a statistical analysis of effectiveness data -- both the subset of speech intelligibility measures used during the postapproval study as described in amendment#11, dated June 20, 1997, and the Reynell test of expressive and receptive ability.Results of the long-term data must be reflected in the labeling, via a PMA supplement, when the postapproval study is completed.
P810046|S182|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS TX 2000 VP CORONARY DILATATION CATHETER          CAHTETERS|LOX|CV|Normal 180 Day Track||N|11/24/1997|01/27/1998|N||APPR|Approval for an E-beam sterilization process validation protocol and a manufacturing site located at Guidant Corporation, Advanced Cardiovascular Systems, 26531 Ynez Rd., Temecula, CA  92591-4628.
P880027|S054|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BONNIE TM SLIDING RAIL PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1997|12/23/1997|||APPR|Approval for modified labeling for the Magic Help Threader which is packaged with the Bonnie(TM) PTCA Catheters.
P930038|S011|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/1997|12/23/1997|||APPR|Approval for changes to the in-coming specifications for the anchor material.
N17511|S012|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON (32% DEXTRAN 70)|LTA|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/1997|12/30/1997|||APPR|Approval for a manufacturing facility located at NPBI, Nederlands Produktielaboratorium Voor, Bloedtransfusieapparatuur en Infusievloeistoffen B.V., Runde ZZ 41, 7881 HM Emmer-Compascuum, The Netherlands.
P960040|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV DDD FAMILY OF AICD SYSTEMS||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/1997|12/04/1997|N||APPR|Approval for Software Application Model 2833 Version 3.0 which corrects a hardware limit anomaly.
P880047|S005|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED TC7  ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/03/1997|02/09/1998|||APPR|Approval for 1)the addition of an alternate 60 denier yarn constructed of 24 filaments instead of 18 filaments, and 2) the addition of the alternate final product release site of somerville, New Jersey.  The device, as modified, will be marketed under the trade name INTERCEED*(TC7) and is indicated as an adhesion barrier to be used as an adjuvant to gynecologic pelvic surgery.
P880003|S072|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CHARGER PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1997|06/03/1998|||APPR|Approval for an additional marker band on the 10 mm balloon length of the Cordis Charger(TM) PTCA Dilatation Catheters.
P880086|S043|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TRILOGY DC+ MODEL 2318L PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/1997|12/29/1997|||APPR|Approval for the APS III Model 3500 with Model 3302 Software Version 1.02.
P830045|S055|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|APS III MODEL 3500 PROGRAMMER|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/1997|12/29/1997|||APPR|Approval for the APS III Model 3500 with Model 3302 Software Version 1.02.
P840024|S073|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1997|01/12/1998|||APPR|Approval to modify the locating rabs on the battery lids of the Mini Speech Processor case and the Spectra Speech Processor case.
P890027|S042|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/1997|01/12/1998|||APPR|Approval to modify the locating tabs on the battery lids of the Mini Speech Processor case and the Spectra Speech Processor case.
P870018|S019|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR MULTILINE|LNS|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/11/1997|12/29/1997|||APRL|Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
P960042|S001|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159||SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1997|06/16/1998|||APPR|Approval for the 12 French Outer Sheath.  The device is an accessory to the 12 French Laser Sheath and will be packaged in the 12 French Laser Sheath Kit.
P960013|S002|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|LOCATOR STEERABLE STYLET MODEL 4036|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/1997|06/15/1998|||APPR|
P910016|S010|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|LCS(R)TOTAL KNEE SYSTEM|MBD|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/1997|01/15/1998|||APPR|Approval for the use of multilingual package labeling and a multilingual package insert for the components of the Unicompartmental Configuration of the LCS(R) Total Knee System.
P900043|S008|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/1997|06/08/1998|||APPR|Approval for the indication of treatment of restenotic native coronary artery lesions with a reference diameter in the range of 3-4 mm, and modifications to the current label that include addition of the Stars Trial results to the clinical summary section.
P920004|S009|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL ANCHOR DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/16/1997|06/12/1998|||APPR|Approval for modifying the precautions section of the VasoSeal(R) Instructions for Use regarding repuncture of a previously treated VasoSeal(R) site.
P950002|S005|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK INTERBODY FUSION SYSTEM|MAX|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/1997|02/06/1998|||APPR|Approval for an additional packaging configuration and gamma sterilization for the BAK and BAK/Proximity implants.
P930038|S012|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/1997|06/16/1998|||APPR|Approval for changes in the design of the anchor and collagen sponge componenets of the Agnio-Seal(TM) device.
P810046|S183|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ROCKET ACS AVENGER CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/1997|05/14/1998|||APPR|Approval for the ACS RX Rocket(TM) and ACS Avenger(TM) Coronary Dilatation Catheters with design modifications and additional balloon sizes for the ACS RX Rocket(TM) Coronary Dilatation Catheter.
P970030|S001|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TORONTO SPV VALVE|LWR|CV|Normal 180 Day Track|Other Report|N|12/22/1997|09/30/1998|||APPR|Approval for the proposed post-approval study protocols submitted in response to fda's conditions of approval, items 1 and 2.
P870072|S006|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/1997|01/21/1998|N||APPR|Approval for 1) changing the thread sealant/thread locking material for the stinless steel pneumatic driveline fitting to the polysulfone VAD case cap from room temperature vulcanizing (RTV) silicone to Master Bond Polymer System EP21LV, and 2) replacing the current two-piece welded hand pump bulb witha  single-piece molded bulb.
P860022|S049|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|IPAFLUOROFOCON A AND B|HQD|OP|Normal 180 Day Track|Other Report|N|12/22/1997|02/06/1998|||APPR|Approval for one additional finishing laboratory to become an additional manufacturer and distributor of the contact lenses.  The laboratory to be added is Gelflex Laboratories, 3 Hutton Street, Osborne Park, Perth, Wester Australia 60017.
P940022|S004|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342|||CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1997|03/17/1998|||APPR|Approval of a modified ICS lead electrode, i.e., the Flex Lead Electrode.
P960058|S003|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/1997|03/17/1998|||APPR|Approval of a modified ICS electrode, i.e., the Flex Lead Electrode.
P930012|S009|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|CHAMPION WRAP PTCA CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/08/1998|02/23/1998|||APPR|Approval for the addition of (1) quarter-size diameter balloons, including sizes of 2.5 mm, 2.75 mm, 3.25 mm, 3.75 mm, 4.25 mm, and 4.5 mm, and (2) a second radiopaque marker to all 20 mm long balloon catheters.  The referenced devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P970031|S003|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/24/1997|06/16/1998|||APPR|Approval for the patient brochure for the device.
P910023|S032|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Other Report|N|12/29/1997|02/02/1998|||APPR|Approval for use of Ventritex Contour(TM) Model V-145 and Contour(TM) LT Model V-135 pulse generators with the Medtronic(R) Transvene(R) Leads and changes in the Physician's Manuals.
P910020|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|MOMENTUM PACERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/08/1998|01/30/1998|||APPR|Approval for the Edgeband Design on the Marathon SR Model 292-09, Relay Model 293-03, Marathon DR Model 293-09, Marathon DR Model 294-09, and Mementum DR Model 294-23.  The devices, as modified, will be marketed under the trade name Edgeband pacemakers, with the following models:  Marathon SR Model 292-09E, Relay Model 293-03E, Marathone DR Model 293-09E, Marathon DR Model 294-09E, and Momentum DR Model 294-23E.  The supplement also requested approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all Edgeband and all Side-Lock(TM) pulse generator models.
P950014|S011|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PRAKTIS|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/1997|03/13/1998|||APPR|Approval for a new hardware and software configuration of the Prostatron(TM).  The device, as modified, will be marketed under the trade name Prostatron(TM) Praktis and is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia (BPH).  It is intended that the Prostatron(TM) Praktis deliver a complete thermal therapy treatment during a single treatment session.  The Prostatron(TM) Praktis is available with two treatment protocols, each requiring a unique treatment catheter.  Protocol 2.0, which uses the standard Prostaprobe (Black) treatment catheter, is indicated for patients with prostatic lengths of 35 to 50 mm.  The higher energy Protocol 2.5, which uses the Prostaprobe (Blue) treatment catheter, is indicated for patients with prostatic lengths of 25 to 50 mm in whom the benefits of obstructive improvement outweigh the attendant risks.
P890014|S002|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|DIASORIN ETI-HA-IGMK PLUS|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1997|09/16/1998|||APPR|Approval for a change in the Enzyme tracer and Tracer Diluent from a IgG (sheep) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a chang ein the Positive Control material to a human source sera; the elimination of the mercury preservative in the reagents; a change in the incubation times from an overnight procedure to a four and one-half hour incubation; the addition of an indicator dye; and the addition of a Calibrator reagent.  The device, as modified, will be marketed under the trade name DiaSorin ETI-HA-IGMK PLUS and is intended for use in the qualitative determination of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum or plasma.  This assay is indicated for use as an aid in the diagnosis and monitoring of acute or recent hepatitis A virus infection.
P890019|S005|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1997|09/22/1998|||APPR|Approval for a change in the Enzyme tracer and Tracer Diluent from an IgG (Human) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a change in the Positive Control and Negative Control materials to human source sera; the elimination of the mercury preservative in the reagents; and the addition of a neutralizing solution, incubation buffer and a Calibrator reagent.  The device, as modified, will be marketed under the trade name DiaSorin ETI-AB-HAVK PLUS and is intended for the qualitative determination of total antiboides to hepatitis A virus (anti-HAV) in human serum or plasma.  This assay is indicated for use as an aid in the dignosis of current or previous hepatitis A virus infection and  as an aid in the diagnosis of current or previous hepatitis A virus infection and as an aid in the identification of HAV-susceptible individuals for vaccination.
P940008|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RES-Q(TM) MICRON ICD SYSTEM||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/1997|03/17/1998|||APPR|Approval for new Models of Res-Q(TM) Micron ICD (Models 101-10 and 101-10A) and modifications to the existing Res-Q(TM) Micron ICD Models 101-05, and 101-09.
P880091|S014|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, TORIC OPTICS|UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC|MJP|OP|Panel Track|Change Design/Components/Specifications/Material|N|12/16/1997|11/04/1998|98M-0998|12/17/1998|APPR|This device is indicated for improving uncorrected visual acuity, correcting aphakia and decreasing refractive cylinder resulting from corneal astigmatism in persons aged 60 and over.
P910066|S008|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/30/1997|06/12/1998|||APPR|Approval for a change in the indications for use language to state "The Orthologic 1000 Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones.  A nonunion is considered to be established when the fracture site show no visibly progressive sign s of healing"; and "The Orthologic CC Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauam, ecxluding vertebrae and all flate bones.  A nonunion is considred to be established when the fracture site shows no visibly progressive signs of healing."
P900023|S026|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/02/1998|02/02/1998|||APPR|Approval to change the current BVS battery to a Hawker Genesis HrD 13 Ah battery, Model G12V13Ah10EP.
P870080|S001|RICHARD WOLF MEDICAL INSTRUMENTS CORP.|353 CORPORATE WOODS PKWY.||VERNON HILLS|IL|60061||Laparoscopic contraceptive tubal occlusion device|HULKA CLIP FOR TUBAL OCCLUSION|KNH|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/1998|03/12/1998|||APPR|Approval for the instruction manual "Hulka Clips for Hulka Clip Applicators" - E36 to be included with each box of clips sold.
P960007|S007|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT-TC(TM)|MGR|SU|Normal 180 Day Track|Other Report|N|01/09/1998|05/29/1998|||APPR|Approval for a post approval study assessing the incidence of burn wound infection in patients who require a temporary wound covering, Dermagraft-TC, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patients who require such a covering prior to autograft placement.
P930021|S001|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|BIORA EMDOGAIN(R)|NQA|DE|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/1998|05/18/1999|||APPR|Approval for manufacturing and packaging changes for EMDOGAIN(R).
P860019|S137|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED REBEL PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/1998|04/15/1998|||APPR|Approval for placement of additional marker bands on the 20 mm and 30 mm SCIMED REBEL PTCA Catheters.
P950014|S012|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON MAXIS|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/14/1998|01/22/1998|||APPR|Approval for a new trade name for the single-module configuration of the PRostatron.  The device will be marketed under the trade name Prostatron Maxis and is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).
P900007|S001|Cook Incorporated|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||CATHETER, SAMPLING, CHORIONIC VILLUS|COOK CHORIONIC VILLUS SAMPLING SET|LLX|OB|Normal 180 Day Track|Other Report|N|01/15/1998|07/08/1998|||APPR|Approval for removing the condition of approval regarding collection of individual outcome data from each CVS case.
P860004|S040|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Normal 180 Day Track||N|01/15/1998|04/13/1998|||APPR|Approval to modify the prescription caution statement on the SynchroMed prouduct labeling from "Caution: Federal law restricts this device to sale, distribution, and use by or on the order of a physician," to that specified in 21 CFR 801.109(b)(1), "Caution:  Federal law restricts this device to sale by or on the order of a physician".  FDA also acknowledges and approves the substitution of "(USA)" for "Federal law" for devices distributed outside of the United States.
P860064|S009|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DUPEN LONG TERM EPIDURAL CATHETER|LNY|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/1998|01/26/1998|||APPR|Approval for modifications to the instructions for use (IFU) for the DuPen Long Term Epidural Catheter and the DuPen Catheter Repair Kit.  These six modifications are:  1) to delete references to resterilization of product; 2) to add a caution to the Repair Kit IFU to examine the package and not use or resterilize if package is damaged; 3) to add the prescription statement to the Repair Kit IFU; 4) To add international units of measurea nd general international requirements; 5) To add a general biohazard statement concerning handling of product after use to the IFUs and product labels; and 6) to add an international symbol (explained in the device IFU) tot he external catheter sleeve "Attention, See Instructions for Use."
P790017|S064|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|TELESCOPE PTCA BALLOON CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/20/1998|02/12/1998|||APPR|Approval to sell the USCI(R) Telescope(TM) Balloon Dilatation Catheter with Hydro/Pel(R) Coating to Cordis Corp. for distribution.
P810046|S185|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/20/1998|06/08/1998|||APPR|Approval for an additional balloon length, the addition of HYDROCOAT(TM) hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and packaging and an increase in the rated ubrst pressure for the 3.25mm through 4.0mm balloon diameters.  The device as modified, will be marketed under the trade name ACS RX Comet VP(TM) Coronary Dilatation Catheters with HYDROCOAT(TM) Hydrophilic coating and is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improvng myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purose of restoring coronary flow in patients with ST-segment elevation yocardial infarction.
P970031|S004|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Other Report|N|01/12/1998|09/18/1998|N||APPR|Approval for the protocols to be used for the short term and long term post approval studies.
P850079|S029|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/1998|07/02/1998|||APPR|Approval for spherical and toric configurations (clear and visibility tinted) of methafilcon A hydrophilic contact lenses for extended wear manufactured by a cast-molding process by Aspect Vision Care, Ltd., Hamble, United Kingdom.
P920034|S002|MEDIREX, INC.|49 WALNUT PARK||WELLESLEY HILLS|MA|02181||Lithotriptor, extracorporeal shock-wave,urological|TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/1998|03/05/1998|||APRL|Approval for non-electrocardiographic (ECG) gating in patients with renal and upper tract calculi.
P960040|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV DDD FAMILY OF AICD SYSTEMS||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/1998|02/02/1998|||APPR|Approval for changes in the VENTAK(R) AV II Physician's Manual and Device Warranty.
P810046|S186|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/23/1998|03/13/1998|||APPR|Approval for ACS Swap-It(TM) Guide Wire Exchange Device which is an accessory to Guidant ACS RX (Rail) catheters.  This device will be marketed under the trade name ACS Swap-It(TM) Guide Wire Exchange Device and is indicated for use within a guiding catheter to facilitate the exchange of a 0.014 inch guide wire while maintaining the position of an ACS RX(R) (Rail) catheter.
P950002|S006|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK INTERBODY FUSION SYSTEM|MAX|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/1998|05/12/1998|||APPR|Approval for a new manufacturing site for the BAK and BAK/Proximity implants, Riteway Precision Machine, Inc.
P810046|S187|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/1998|12/28/1998|||APPR|Approval to conduct pyrogen testing of ACS Coronary Dilatation Catheters prior to sterilization by E-beam radiation.
P880031|S012|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|AMO(R) VITRAX(R) VISCOELASTIC SOLUTION|LZP|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/1998|02/19/1998|||APPR|Approval for a modification to final product release testing requirements for AMO(R) VITRAX(R).
P910030|S008|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||STENT, CORONARY|GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/1998|05/05/1998|||APPR|Approval for a labeling change in the Instructions for Use ("Technical Information and Suggested Instructions for Placement") of the GR II(TM) Coronary Stent.
P970035|S002|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/1998|02/23/1998|||APPR|Approval for a manufacturing site located at 3576 Unocal Place, Bldg. B, Santa Rosa, CA and 7975 Cameron Drive (extrusion) Windsor, CA.
P900056|S023|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM CONTRACT STERILIZER|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/1998|02/23/1998|||APPR|Approval for an alternate contract sterilizer at Griffith Micro Science, New York facility, 84 Park Road, Queensbury, NY 12804.
P920032|S004|PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE|MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER|JOQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/1998|02/27/1998|||APPR|Approval for a modified switch guard design.
P790018|S032|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/1998|07/01/1998|||APPR|Approval to manufacture the sewing ring component of the Medtronic Hall(TM) Prosthetic Heart Valves with knitted polytetrafluoroethylene (PTFE) fabric constructed of PTFE yarn from an alternate supplier.  The models affected by the change include Model A7700 (sizes 21, 23, 25, 27, 29, and 31 mm) and Model M7700 (sizes 23, 25, 27, 29, and 31 mm).
P880006|S026|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/1998|05/07/1998|||APPR|Approval for the Regency SC+, Regency SC, and Regency SCX Pulse Generators which are programmed by the APS II Programmer with Model 3204a Function Pack.
P970020|S001|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591|||ACS MULTI-LINK TM CORONARY STENT SYSTEM WITH THE 25MM STENT LENGTH||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/03/1998|08/04/1998|||APPR|Approval for ACS RX Multi-Link HP(TM) Coronary Stent System with the 25 mm stent length.
P910019|S005|INTENSIVE TECHNOLOGY, INC.|3574 RUFFIN RD.||SAN DIEGO|CA|92123||CATHETER, CORONARY, ATHERECTOMY|IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/1998|02/23/1998|||APPR|Approval for a change to the 5.5F-7.5F TEC cutter catheters, involving the addition of a spiral groove on the inner surface of the cutter component.
N17004|S011|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT|LOD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/1998|03/18/1998|||APPR|Approval for Isotron Ireland, LTD., to be certified as an alternate supplier for your ETO sterilization process.
P780012|S008|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|IMX(R) HAVAB|LOL|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/06/1998|05/12/1998|||APPR|Approval for the Abbott IMx(R) HAVAB(R).  This device is indicated for the qualitative determiantion of total antibody to heaptitis A antigen in human serum or plasma.
P970003|S008|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROTHESIS SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1998|03/13/1998|||OK30|
P840024|S074|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/1998|03/06/1998|||APPR|Approval for changes in the package insert labeling to 1) include the indication for children age 18 months to 17 years and 2) to modify the adverse effects section.
P890027|S043|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/1998|03/06/1998|||APPR|Approval for changes in the package insert labeling to 1) include the indication for children age 18 months to 17 years and 2) to modify the adverse effects section.
P970021|S001|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM|MNB|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/1998|03/06/1998|||APPR|Approval for a new manufacturing site located at SeaMed Corporation, 21621 30th Ave., NE, Bothell, WA  98021.
P950034|S008|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/1998|08/18/1998|||APPR|Approval for the extension of the expiration dating period for Seprafilm(R) Bioresorbable membrane from 24 monts to 30 months.
P970008|S005|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIC TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/1998|02/20/1998|||APPR|Approval for changes to allow for the transport of the Targis(TM) Control Unit from site to site.
P860019|S138|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED REBEL PTCA CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/1998|04/06/1998|||APPR|Approval for additional balloon lengths of 16 mm and 18 mm with balloon sizes of 2.5 mm up to 4.0 mm in 1/4 mm increments for the SCIMED(R) NC Ranger(TM) PTCA Catheter.
P950035|S001|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM(R)|GZC|EN|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1998|03/20/1998|||APPR|Approval for a change in the supplier of the Platinum-Iridium (Pt-Ir) electrode discs used in the manufacture of the Freehand Epimysial Electrodes and a change in the Model Numbering for the Freehand System.
P790017|S065|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/1998|03/23/1998|||APPR|Approval for a new PTCA catheter line.  The device, as modified, will be marketed under the trade name USCI(R) Apollo(TM) Rely(R) SP Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel(R) Coating and Miniquet Device and is indicated for balloon dilatation  of the stenotic portion of a coronary artery or bypass graft stenosisfor the purpose of improving myocardial perfusion.
P920048|S002|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|ADEZA FETAL FIBRONECTIN EIK|LKV|CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|02/13/1998|08/14/1998|||APPR|Approval for a rapid, qualitative test for detecting the presence of fetal fibronective (fFN) in cerviocovaginal secretions.  The device, as modified, will be marketed under the trade name Fetal Fibronectin Rapid System and is indicated as an aid to rapidly assess the risk of preterm delivery in <7 or <14 days from the time of cervicovaginal sample collection in pregnant women withsigns and symptoms of early preterm labor intact amniotic membranes and minimal cervical dilatation (<3 cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation.  The device is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in <34 weeks, 6 days when a cerviocovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.
N17679|S032|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|VANTAGE (TETRAFILCON A ) CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1998|07/02/1998|||APPR|Approval for the following: 1)Aspect Vision Care, Ltd., Hamble, United Kingdom as an alternate manufacturing site; 2)an alternate manufacturing process of fully molded; 3)a change in the initiator used in the polymerization method; and 4)expansion of the parameter range.
P900061|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC(R) MODEL 7227CX GEM (TM) IMPLANTABLE CARDIOVERTER|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/1998|10/05/1998|||APPR|Approval for the Medtronic(R) Model 7227Cx GEM(TM) Implantabel Cardioverter Defibrillator with Model 9962 Software and the Model 9466 Patient Magnet.
P910020|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/1998|05/21/1998|||APPR|Approval for the following pacemakers which incorporate the Edgebadn Design: Cosmos 3 Model 284-09E; Cosmos II Model 284-05E; Stride Model 294-05E; Dash Model 292-03E; Dart Model 292-05E; Unity Model 292-07E; Nova III Model 282-07E; and the Quantum III Model 254-27E.  Supplement is approved for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all the Edgeband models listed above and the folowing additional models: the Side-Lock(TM) implantable pulse generator models 282-07, 254-27, and 254-31, and the Nova II Model 281-05 and Nova III Model 282-04 pulse generators.
P830026|S071|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/1998|05/21/1998|||APPR|Approval for the following pacemakers whcih incorporate the Edgeband Design:  Cosmos 3 Model 284-09E; Cosmos II Model 284-05E; Stride Model 294-05E; Dash Model 292-03E; Dart Model 292-05E; Unity Model 292-07E; Nova III Model 282-07E; and theQuantum III Model 254-27E.  In addition approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all the Edgeband models listed above and the following additional models:  the Side-Lock(TM) implantable pulse generator models 282-07, 254-27, and 254-31, and the Nova II Model 281-05 and Nova III Model 282-04 pulse generators.
P880065|S004|Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||PULSE-GENERATOR, PROGRAM MODULE|MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER|LOT|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1998|04/21/1999|||APPR|Approval for a manufacturing site located at SCIMED Life Systems, Inc., Two SCIMED Place, Maple Grove, MN  55311.
P910073|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/1998|08/13/1998|||APPR|Approval for a design change to provide higher pacing impedance.  Teh device, as modified, will be marketed under the trade name ENDOTAK(R) Endurance(TM) Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and delivery cardioversiona nd defibrillation shocks for AICD automatic implantable cardioverter defibrillator systems.
P860022|S050|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|IPAFLUOROFOCON A AND B|HQD|OP|THIRTY DAY TRACK|Change Design/Components/Specifications/Material|N|02/20/1998|03/31/1998|||APPR|Approval for the three additional finishing laboratories listed to become additional manufacturers and distributors of the device:Premier Contact Lens, 111 28th Avenue South, Nashville, TN  37212 and Premier Contact Lens, 3614 S.Perkins, Memphis, TN  38118.
P930012|S010|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|CHAMPION WRAP PTCA CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/08/1998|06/15/1998|||APPR|Approval for 1) a change in trade names for the Champion(TM) HP PTCA Catheters and Champion(TM) HP PTCA Catheters with Wrap(TM) Sheathing System previously approved under PMA supplements 5, 8, and 9, and 2) a reduction in the wall thickness of the 3.5 mm and 4.0 mm diameter balloons used in these designs.  the devices, as modified, will be marketed under the trde names Champion(TM) NC PTCA Catheter and Wrap(TM) NC PTCA Catheter, and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P970020|S002|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/1998|02/03/1999|||APPR|Approval for an alternate method of sterilization (Electron Beam) for the ACS RX Multi-Link(TM) HP and the ACS OTW Multi-Link(TM) HP Coronary Stent Systems.
P930027|S003|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|IMMULITE PSA CATALOG # LKPS1,5)|LTJ|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/1998|05/08/1998|||APPR|Approval for adding information on the percentage for each PSA range for healthy male subjects as one group in the expected value section.
P970031|S005|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Other Report|N|02/11/1998|09/18/1998|N||APPR|Approval for the protocols to be used for the short term and long term post approval studies.
P970012|S001|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/1998|05/21/1998|||APPR|Approval for an update to the Medtronic.Vision Software Model 9952 - Series 2.0.  The update will add the ability to program the Medtronic.Kappa 400 Models K(DR) 401/403, K(SR) 401/403, the Medtronic DX2 Models 7970/7972, and will add Electrophysiological Studies (EPS) capability to the Kappa 400 pacemakers.  The update also incorporates performance enhancements which shorten boot and application load times, provide quicker screen transitions, and reporting and usability enhancements.
P940031|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/1998|03/27/1998|||APPR|Approval for design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the VIGOR Models 950, 1230, and 1232.
P840068|S034|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/1998|03/27/1998|||APPR|Approval for design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the VIGOR Models 950, 1230, and 1232.
P860019|S140|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/1998|08/24/1998|||APPR|Approval for a modified WRAP-IT(TM) Accessory Tool for use with the SCIMED(R) NC PTCA Catheters.
P860019|S141|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/18/1998|09/30/1998|||APPR|Approval for a new indication for the SCIMED(R) Quantum Ranger(TM) PTCA Catheter.  The new indication is for post-delivery expansion of balloon expandable stents.
P870015|S028|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/1998|03/05/1998|||APRL|Approval for modification of the Medstone STS(TM) Lithotripter to include an alternate model x-ray generator (i.e., the Creos XHF-40PF).
P870056|S006|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/1998|08/07/1998|||APPR|Approval for adding the Model 4300 valved conduit and is indicated for correction of pulmonary stenosis or atresia and complex congenital malformations requiring Rastelli-type operations, and for correction of tricuspid atresia.
P840008|S062|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER AND DORNIER COMPACT S LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/1998|05/14/1998|||APRL|Approval for hardware and software modifications to the Dornier Lithotripter and Dornier Compact S Lithotripter, including modifications to the shock wave therapy source of each system.
P970004|S002|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/1998|07/08/1998|||APPR|Approval for marketing the Medtronic InterStim(R) Model 3023 Implantable Pulse Generator (IPG) and its control devices (model 3031 Patient Programmer with Model 7440 Optional antenna and Model 3051 Software Cartridge Memory Module (MemMod(R)) and is indicated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.
P930039|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE FIX MODELS 4067,4068, 4568,5068,5568 PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/1998|09/01/1998|||APPR|Approval for modifications to the CapSureFix(R) pacing lead family.
P830061|S027|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/1998|08/27/1998|||APPR|Approval for new pacing leads models.  The devices, as modified, will be marketed under the trade names CapSure(R) SP Novus Models 4092 and 4592 and Vitatron Excellence PS+ Models IMK49B and IMK49JB and are indicated for permanent pacing and sensing of the strium or ventricle.
P970002|S001|ALLIANCE MEDICAL TECHNOLOGIES, INC.|17590 GILLETTE AVE.||IRVINE,|CA|92614||HEART-VALVE, MECHANICAL|MONOSTRUT CARDIAC VALVE PROSTHESIS|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/1998|03/23/1998|||OK30|
P850007|S021|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|SPINAL-STIM LITE SPINAL FUSION SYSTEM|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/1998|05/14/1998|||APPR|Approval for the Spinal-Stim(R) Lite Spinal Fusion System, Model 212LE. The device will be marketed under the trade name Spinal-Stim(R) and is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
P950014|S013|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON MAXIS|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/1998|03/10/1998|||APPR|Approval for 1) the addition of a barcode identification label to the Prostaprobe, and 2) modifications to the Prostatron(TM) Maxis and dual module configurations to require entry of the Prostaprobe barcode information prior to treatment.
P960047|S001|HOWMEDICA OSTEONICS CORP.|59 ROUTE 17 SOUTH||ALLENDALE|NJ|07401|1677||OSTEONICS CONSTRAINED ACETABULAR INSERT||OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/1998|04/02/1998|N||APPR|Approval for: 1) The introduction of 10 additional sizes to the PMA-approved constrained acetabular insert product line; 2) A minor modification in the packaging scheme applicable to the PMA-approved constrained acetabular insert product line; 3) Manufacturing tolerance changes to the PMA-approved constrained acetabular insert product line; and 4) An inspection code modification on the engineering drawing for the PMA-approved constrained acetabular insert product line.  The device, as modified, will be marketed under the trade name Osteonics Constrained Acetabular Insert and is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
P930016|S006|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S2 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/26/1998|03/20/1998|||APPR|Approval for for 1)laser removal of the epithelium; 2)visibility upgrade; 3)swivel mounted vacuum nozzle; 4)integrated hardware module with all unapproved indications "locked out"; 5)variable Hertz rate from 1.5 to 10 Hertz; 6)smoothing; 7)installation of software Version 2.2 with all unapproved indications "locked out"; and, 8)revised Operator's Manual.  The device as modified will be marketed under the trade name VISX START S2 Excimer Laser System and is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0mm major axis.  The PRK procedure is intended for use:  1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2)in patient 18-20 years of age in PRK treatment for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0D sphereical equivalent at the corneal plane with less than or equal to -1.0D of astigmatism; or 3)in patients 21 years of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0D spherical myopia at the spectacle plane and up to -4.0D of astigmatism.
P930016|S007|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S2 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/1998|11/02/1998|00M-1391|07/14/2000|APPR|Approval for the VISX Excimer Laser System.  This device is indicated for hyperopic PRK using an ablation zone with a correction diameter of 5.0 mm and an overall diameter of 9.0mm.
P900043|S009|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/1998|06/24/1998|||APPR|Approval for addition of the patient manual titled "Understanding Coronary Artery Disease and your Stent:  A Guide for Patients.".
P930038|S013|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/1998|02/12/1999|||APPR|Approval for modifications to the suture tensioning mechanism component of the Angio-Seal(TM) device.
P790017|S066|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|USCI APOLLO RELY ADDITIONAL SIZES|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/1998|05/18/1998|||APPR|Approval for the addition of three balloon sizes to the USCI(R) Apollo(TM) Rely(R) Over-the-Wire Balloon Dilatation Catheter with Hydro/Pel(R) Coating and Miniquet Device catheter line.  The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P960043|S005|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1998|09/02/1998|||APPR|Approval for a modified Percutaneous Vascular Surgical (PVS) System.  The device, as modified, will be marketed under the trade name Prostar(R) XL 10 French Percutaneous Vascular Surgical (PVS) System and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths.
P960042|S002|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159||14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/1998|09/04/1998|||APPR|Approval for the 14 French (Fr.) and 16 Fr. Laser Sheath Kits and individually packaged accessory devices (14 Fr. and 16 Fr. Outer Sheaths and Fish Tape).  The Laser Sheath Kits include:  one Laser Sheath (14 Fr. or 16 Fr.), two Outer Sheaths (14 Fr. or 16 Fr.), and a Fish Tape.  The laser Sheath Kits, as modified, will be marketed under the trade names 14 Fr. and 16 Fr. Laser Sheath Kits and are indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
P970003|S009|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROTHESIS SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1998|03/13/1998|||OK30|
P860022|S051|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|ITAFLUOROFOCON A AND B|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/1998|03/31/1998|||APPR|Approval for an additional finishing laboratory to become an additional manufacturer and distributor for the device:Diversified Ophthalmics, 1308 West 500 North, Salt Lake City, UT 84116.
P830045|S056|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|APSU PROGRAMMER, APSU SOFTWARE, BASE STATION|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/1998|09/04/1998|||APPR|Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.
P880006|S027|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APSU PROGRAMMER, APSU SOFTWARE, BASE STATION|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/1998|09/04/1998|||APPR|Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.
P960043|S006|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/13/1998|04/06/1998|||APPR|Approval for changes to the PVS patient guide and post-procedure (nursing) guide.
P880086|S045|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APSU PROGRAMMER, APSU SOFTWARE, BASE STATION|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/1998|09/04/1998|||APPR|approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, jarfalla, Sweden.
P880086|S046|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APSU PROGRAMMER, APSU SOFTWARE, BASE STATION|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/1998|09/03/1998|||APPR|Approval for modifications to the approved labeling including: the addition of a "Cellular Tested" logo and associated language in the Patient and Physican manuals specifying those cellular telephone protocols for which testing has been peroformed and shown no interaction.
P900070|S022|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|TEMPO PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/1998|09/03/1998|||APPR|Approval for modifications to the approved labeling including the: addition of a "Cellular Tested" logo and associated language in the Patient and Physician manuals specifying those cellular telephone protocols for which testing has been performed and shown no interaction.
P860019|S142|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/1998|05/13/1998|||APPR|Approval to extend the product line of the SCIMED(R) NC Ranger(TM) PTCA Catheter to include a 9 mm length balloon with diameters ranger from 2.5 mm to 4.0 mm in 0.25 mm increments.  The device, as modified, will be marketed under the trade name SCIMED(R) 9 mm NC Ranger(TM) PTCA Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P870015|S029|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS(TM) LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/1998|03/27/1998|||APRL|Approval for modification of the Medstone STS(TM) Lithotripter to include an alternate model x-ray generator (i.e., the Creos XHF-30-ESU).
P890027|S044|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/1998|04/01/1998|||OK30|The 30-day Notice requested a change in the cleaning operations of the Cochlear Implant Components from the present use of Freon to the proposed use of a general purpose degreaser 4-850.
P840024|S075|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/1998|04/01/1998|||OK30|The 30-day Notice requested a change in the cleaning operations of the Cochlear Implant Components from the present use of Freon to the proposed use of a general purpose degreaser 4-850.
P910001|S013|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/1998|03/12/1999|||APPR|Approval for Software Versions 3.51 and 3.6.
P840064|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(R) VISCOELASTIC SOLUTION|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/1998|06/29/1998|||APPR|Approval for the addition of a cannula locking ring to the currentl-marketed delivery system for VISCOAT(R).
P790017|S067|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/1998|09/18/1998|||APPR|Approval to market new PTCA catheter models.  The devices, as modified, will be marketed under the trade names USCI(R) Neptune(TM) X-act(R) and the Neptune(TM) X-act(R) Duo Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel(R) Coating and Anti Back Bleed Device and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P950005|S002|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|DIAGNOSTIC/ABLATION DEFLECTABLE BRAIDED-TIP CATHETER (WITHOUT THERMOCOUPLE) & CELSIUS (WITH THERMOCOUPLE)|DRF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/1998|07/22/1998|||APPR|Approval for the 7 Fr and 8 Fr braided tip version of the Diagnostic/Ablation Deflectable Tip Catheter (with and without temperature sensors).
P930029|S011|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/1998|04/20/1998|||APPR|Approval for a manufacturing site located at Medtronic Milaca, 900 Sixth Ave., NE, Milaca, MN 56353 (ERN 2183613).
P940010|S004|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE(TM) FIBER OPTIC DIFFUSER|MVG|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/24/1998|12/23/1998|||APPR|Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
P940011|S002|LUMENIS, INC.|3959 WEST 1820 SOUTH||SALT LAKE CITY|UT|84104|||COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS||SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/1998|12/23/1998|||APPR|Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
P830055|S057|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/1998|05/01/1998|||APPR|Approval for the addition of posterior stabilized femoral and tibial bearing components and rotating platform (RP II) tibial trays and bearing components to the LCS(R) Total Knee System.
P940022|S005|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342|||CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/1998|05/28/1998|||APPR|Approval for the modified CLARION device in which the implantable cochlear stimulator (ICS) housing is made of zirconia instead of alumina.  The new housing configuration is to be referred to as the CIM 3.
P960058|S004|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/1998|05/28/1998|||APPR|Approval for the modified CLARION device in which the implantable cochlear stimulator (ICS) housing is made of zirconia instead of alumina.  The new housing configuration is to be referred to as the CIM 3.
P880013|S008|NELLCOR PURITAN BENNETT, INC.|2200 FARADAY AVE.||CARLSBAD|CA|92008|7208|VENTILATOR, HIGH FREQUENCY|HFV INFANT STAR VENTILATOR|LSZ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/1998|04/07/1998|||OK30|
P960053|S001|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, finger, constrained, metal/polymer|TOTAL TRAPEZIO METACARPAL PROSTHESIS|KWG|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/1998|06/04/1998|||APPR|APPROVAL FOR 1) PACKAGING THE IMPLANT IN A SINGLE BOX CONTAINING BOTH THE PROXIMAL AND DISTAL COMPONENTS AND CHANGING PACKAGE LABELS ACCORDINGLY, AND 2) CHANGING THE COLOR OF STOCK USED FOR PRINTING BOX LABELS.
N50510|S080|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/1998|04/14/1998|||APPR|Approval for the addition of a limitation to use an alternative method to confirm results for the testing of Pseudomonas aeruginosa with the antibiotic cefepime.  The device, as modified, will be marketed under the trade name Vitek Gram Negative Susceptibility Card in three concentrations (equivalent to 4, 8 and 16 ug/ml) and is indciated for the testing of rapidly growing aerobic and/or facultatively anaerobic gram negative bacilli.
P940012|S002|AMERICAN MEDICAL SYSTEMS, INC.|10700 BREN ROAD WEST||MINNETONKA|MN|55343|||600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS||SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/24/1998|12/23/1998|||APPR|Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstrucint endobronchial nonsmall cell lung cancer (NSCLC).
P890003|S054|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 8090 ANALYZER MODEL 5436 ANALYZER PATIENT CABLE, 5104/5104ANALYZER ADAPTORS, AND 8190 ANALYZER SOFTWARE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/1998|09/24/1998|||APPR|Approval for the Medtronic "The Analyzer" Lead Analysis dEvice Model 8090 including the Model 5436 Analyzer Patient Cable, the Models 5103 and 5104 Analyzer Adaptors, and the Model 8190 Version 1.1 Software.  "The Analyzer" is attached to the Medtronic Model 9790 Programmer (approved as P890003/S027) and the Model 8190 Software is installed onto the hard dirve of this Programmer.  The device will be marketed under the trade name "Medtronic THE ANALYZER(TM) Lead Analysis Device Model 8090" and is indicated for use by a clinician to assess the pacing and sensing performance of the lead system during arrhythmia management device implantation or during invasive lead system troubleshooting.
P900023|S027|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/1998|05/28/1998|||APPR|Approval for a change in the manufacturing process to allow the outflow connector to be annealed prior to assembly of the blood pump.
P970052|S001|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||Catheters, transluminal coronary angioplasty, percutaneous|LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).|LOX|CV|||N|03/03/1997|04/08/1998|||APPR|
P970052|S002|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||Catheters, transluminal coronary angioplasty, percutaneous|GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1997|05/19/1998|||APPR|Approval for modifications to the Guardian(TM) Balloon Coronary Dilatation Catheter.
P870078|S004|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHETIC HEART VALVE|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1998|08/20/1998|||APPR|Approval for an alternate polyester for use in the sewing ring of the three heart valves.
P790007|S014|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE|LWR|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1998|08/20/1998|||APPR|Approval for an alternate polyester for use in the sewing ring ofthe three heart valves.
P970031|S006|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/1998|08/20/1998|||APPR|Approval for an alternate polyester for use in the sewing ring of the three heart valves
P900052|S005|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST|LNY|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/1998|10/20/1998|||APPR|Approval for 1) The following design modifications to the current, legally marketed PORT-A-CATH(R) II:  a smaller (25.4mm.  based diameter, a 12.7mm. height, and a 8.9mm. septum diameter), lighter weight (5.0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(SS) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the CATH-SHIELD catheter connector; and 2) the labeling revisions as delineated in the first amendment dated 6/23/98.
P950043|S002|MEDISPEC, LTD.|19110 MONTGOMERY VILLAGE AVE.|SUITE 100|MONTGOMERY VILLAGE|MD|20886||Lithotriptor, extracorporeal shock-wave,urological|ECONOLITH(TM) LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/1998|05/05/1998|||APRL|Approval for non-synchronized ESWL, addition of a ECG simulator/adapter, and appropriate labeling revisions.
P910016|S011|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|LCS(R)TOTAL KNEE SYSTEM|MBD|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/1998|03/04/1999|||APPR|Approval for a sterilization site located at DePuy International Ltd., St. Anthony's Road, Leeds LS11 8DT, England.
P830055|S058|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/1998|02/25/1999|||APPR|Approval for a sterilization site located at DePuy International Ltd., St. Anthony's Road, Leeds LS11 8DT, England.
P970012|S002|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/1998|11/19/1998|||APPR|Approval for ICD compatibility labeling for the Medtronic.Kappa 400 pacemaker.
P860019|S143|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/14/1998|09/16/1998|||APPR|Approval for new PTCA catheter models.  The devices, as modified, will be marketed under the trade names SCIMED(R) VIVA(TM) PTCA Catheters and SCIMED(R) LONG VIVA(TM) PTCA Catheters and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P790005|S040|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/1998|05/01/1998|||APPR|Approval for the addition of a 8-cm mesh cathode to be used with the EBI OsteoGen(TM) Bone Growth Stimulator.
P960043|S007|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||PERCLOSE PROSTAR XL 8 & 10 FRENCH PVS SYSTEM||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/1998|05/05/1999|||APPR|Approval for an additional effectiveness claim (i.e., reduced time to discharge) for the Prostar(R) XL 8F Percutaneous Vascular Surgical (PVS) System.  The device will be marketed under the trade name Prostar(R) XL 8F Percutaneous Vascular Surgical (PVS) System and is now indicated for: "the percutaneous delivery of sutures for closing the common femoral artery access site and reducing time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 6.5 Fr. to 8 Fr. sheaths.  The Prostar XL 8 Fr. System reduces the time to discharge in patients having undergone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations)."
P850035|S023|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/1998|05/01/1998|||APPR|Approval for the addition of a 4cm mesh cathode to be used with the SpF-2T stimulator and a 8cm mesh cathode to be used with the SpF-XL IIb stimulator.  The device, as modified, will be marketed under the trade names SpF-2T/CM and SpF-XL IIb 2/DM and is indicated for the same used as the SpF-2T and SpF-XL IIb.
P960009|S002|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|03/05/1998|09/01/1998|||APPR|Approval of a protocol to assess the neurotoxicity and carcinogenicity of the Medtronic Model 3387 DBS Lead.  The work performed under this protocol is intended to fulfill one of the four conditions of approval of the PMA.
P810046|S188|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ROCKET CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/1998|06/29/1998|||APPR|Approval for the addition of two quality control tests to the manufacturing process of the ACS RX ROCKET(TM) Coronary dilatation Catheter.
P960053|S002|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, finger, constrained, metal/polymer|TOTAL TRAPEZIO METACARPAL PROSTHESIS|KWG|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/1998|06/04/1998|||APPR|Approval for 1) packaging the implant in a single box containing both the proximal and distal components and changing package labels accordingly, and 2) changing the color of stock used for printing box labels.
P960019|S002|LASER VISION CENTERS, INC.|540 MARYVILLE CENTRE DR., #200||ST. LOUIS|MO|63141||Excimer laser system|LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)|LZS|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/1998|05/05/1998|||APPR|Approval for two add'l indications, myopic astigmatic PRK (PRKa) and high myopia with and without astigmatism for the device.  The device, as modified, will be marketed under the trade name MobilExcimer(R) for PTK and PRK.  The MobilExcimer(R) for PTK and PRK remains indicated for the indications listed in FDA's letter of 4/27/97 (P960019/S001 and the new indications contained in this supplement.
P920030|S002|BAYER HEALTHCARE, LLC|511 BENEDICT AVE.||TARRYTOWN|NY|10591||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|CIBA CORNING ACS PSA IMMUNOASSAY|LTJ|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/1998|12/08/1998|00M-1536|09/27/2000|APPR|Approval for the addition of a new indication for use.  The device, as modified, will be marketed under the trade names ACS:180 PSA2 assay and ACS:Centaur PSA2 assay and is indicated for the following indications for use: as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older.  Prostatic biopsy is required for the diagnosis of cancer; and as aid in the management of patients with prostate cancer.
P950024|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/1998|08/12/1998|||APPR|Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc.,   (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P930039|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|SUREFIX TM  MODEL 5072 LEAD|DTB|CV|||N|04/20/1998|08/12/1998|||APPR|Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc.,   (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P920015|S014|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6943 AND 6945|LWS|CV|||N|04/20/1998|08/12/1998|||APPR|Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc.,  (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P890003|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE|DXY|CV|||N|04/20/1998|08/12/1998|||APPR|Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc.,(MPRI), Road 149, Rm. 56.3, Vilalba, Puerto Rico 00755.
P850089|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS|DTB|CV|||N|04/20/1998|08/12/1998|||APPR|Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P830061|S028|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/1998|08/12/1998|||APPR|Approval for a manufacturing site located at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
P930031|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/1998|11/30/1998|||APPR|Approval for the Unistep(TM) Plus 8 Fr delivery system.
P960040|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/1998|08/31/1998|||APPR|Approval for the VENTAK(R) AV III DR AICD(TM) System with Model 2843 Software, Version 2.6, the use of Version 2.6 with the VENTAK(R) AV II DR System and modifications to the Physician's Manual and the DR System and modifications tot he Physicians's Manual and the Patient's Manual.
N50510|S081|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL)|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/1998|08/14/1998|||APPR|Approval for the testing of Escherichia coli, Klebsiella pneumoniae, and K. oxytoca for the presence of extended-spectrum beta lactamases (ESBL).
P820076|S021|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|DROMOS S.L. PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/1998|11/04/1998|||APPR|Approval for pacing system which includes a new single-pass VDD pacing lead, a pulse generator with high atrial sensitivity, and a new software module for use with the PMS 1000/1000C programmers.  The device, as modified, will be marketed under the trade name Dromos SL Pacing System SWM 1000/F05.B00.U, and three versions of the single-pass lead, Models SL/11-BP, SL/13-BP and SL/15-BP.  This pacing system is indicated for VDD pacing for patients with a healthy sinus node.
P830055|S059|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO|NJL|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/27/1998|05/14/1998|||APPR|Approval for the use of multilingual package labeling and a multilingual package insert for the components of the LCS(R) Total Knee System.
P860019|S144|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/1998|10/01/1998|||APPR|Approval for the SCIMED(R) MAXXUM(TM) PTCA Catheter.  The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P890003|S056|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/1998|05/21/1998|||APPR|Approval for a hardware upgrade to the Model 9790C Programmer (from a Intel 80486 to an Intel Pentium MMX 166 MHz) and the Model 9891 PE Software.
P860003|S030|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHORESIS SYSTEM|LNR|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/29/1998|09/07/1999|||APPR|Approval for a labeling change to reflect the use of UVADEX(R), the sterile liquid formulation of 8-methoxypsoralen (8-mop).
P870018|S021|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|MODULARIS LITHO|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/1998|09/21/1998|||APRL|Approval for a compact transportable (within the hospital only) configuration of the Lithostar(R) Shock Wave System C.  The device, as modified, will be marketed under the trade name Lithostar(R) Modularis and is indicated for use in the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
P810046|S189|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ESPRIT CORONARY DILATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/1998|06/27/1998|||APPR|Approval for an alternate E-beam sterilization facility located at Titan Scan Systems, 9020 Activity Rd., Suite D, San Diego, CA 92126.
P950042|S001|NOVADAQ TECHNOLOGIES, INC.|2585 SKYMARK AVENUE, STE. 306||MISSISSAUGA, ONTARIO||L4W 4||SYSTEM, IMAGING, FLUORESCENCE|XILLIX-LIFE-LUNG|MRK|EN|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|04/30/1998|07/21/1998|||APPR|Approval to amend the post-market study.  A third investigator will be added to assist in collecting sets of images whichwill be used to produce the "test set" of images for the reproducibility testing.
P970008|S006|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIC TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/05/1998|07/27/1998|||APPR|Approval for an expansion of the indication for use statement to include relief o obstruction.  The indication for use, as modified, is "The Urologix Targis System is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethra lengths of 30 to 50 mm.
P930036|S001|SIEMENS HEALTHCARE DIAGNOSTICS INC.|333 CONEY  STREET||EAST WALPOLE|MA|02032||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACS: CENTAUR AFP IMMUNOASSAY|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|05/01/1998|07/15/1998|||APPR|Approval to add the existing AFP assay performed on the ACS:180 to a new generation of instrumentation, the Centaur and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in the following:human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neura tube defects (NTDs) when used in conjucntion with ultrasonography and amniography testing, using the Chiron Diagnostics ACS:Centaur(TM) Automated Chemiluminescence System.
P890049|S004|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|FINISHED METHAFILCON A CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/1998|05/29/1998|||OK30|
P940031|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/1998|05/28/1998|||APPR|Approval for the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software.
P840068|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/1998|05/28/1998|||APPR|Approval for the VIGOR Model 2880 Software Application, Version 4.1, which corrects anomalies discovered during clinical use of the programmer software.
P950019|S002|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/08/1998|06/08/1998|||APPR|Approval for additional instruments and a change to the surgical technique manual.
P970020|S003|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/11/1998|11/24/1998|||APPR|Approval for a change in the Mean Stent Compliance Outer Diameter specification, associated with the ACS RX Multi-Link HP(TM) and ACS OTW Multi-Link HP(TM) Coronary Stents Systems.
P860057|S006|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|11/28/1997|08/26/1998|||APPR|Approval for closure of the PMA post-approval study for the Model 2700.
P900043|S010|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/12/1998|08/20/1998|||APPR|Approval for a decrease in the distal balloon leg length of the PowerGrip(TM) delivery catheter from 3 mm to 1 mm.
P790007|S015|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE|LWR|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|05/12/1998|10/30/1998|||APPR|Approval for exemption from annual reporting on the post-market study for this device.
P880027|S055|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BONNIE TM SLIDING RAIL PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/1998|06/15/1998|||APPR|Approval for a modified package label, removing specification of the deflated profile.
P860019|S145|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/1998|07/10/1998|||APPR|Approval to extend the product line of the SCIMED(R) Quantum Ranger(TM) PTCA Catheter to include additional balloon lengths of 9 mm, 16 mm, and 18 mm with balloon diameters ranging from 2.5 mm to 4.0 mm in 0.25 mm increments and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P910067|S003|SUMMIT TECHNOLOGY, INC.|21 HICKORY DR.||WALTHAM|MA|02154||Excimer laser system|SVS APEX PLUS EXCIMER LASER WORKSTATION|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/1998|06/04/1998|||APPR|Approval for an external chiller option for the SVS Apex Plus Excimer Laser System.
P970020|S004|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX DUET TM AND ACS MULTI-LINK OTW DUET TM CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/1998|11/05/1998|||APPR|Approval for the ACS Multi-Link RX Duet(TM) and ACS Multi-Link OTW Duet(TM) Coronary Stent Systems.  These devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic lesions in native coronary arteries (length < 25mm) with a reference vessel diameter ranging from 3.0 mm to 4.0 mm.
P880003|S074|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CHARGER PTCA DILATATION CATHETERS|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/13/1998|08/10/1998|||APPR|Approval for addition of 1.5 mm and 2.0 mm balloon diamters with 20, 30 and 40 mm balloon lenghts, and 4.5 mm and 5.0 mm balloon diameters with 20 mm balloon length to the Charger(TM) PTCA Dilatation Catheter line.
P930034|S011|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX PLUS EXCIMER LASER WORKSTATION|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/1998|06/04/1998|||APPR|Approval for an external chiller option for the SVS Apex Plus Excimer Lasery System.
P950043|S004|MEDISPEC, LTD.|19110 MONTGOMERY VILLAGE AVE.|SUITE 100|MONTGOMERY VILLAGE|MD|20886||Lithotriptor, extracorporeal shock-wave,urological|ECONOLITH(TM) LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/1998|05/21/1998|||APRL|Approval for minor labeling and hardware changes.
P970019|S002|HEALTH TRONICS SURGICAL SERVICES, INC.|425 FRANKLIN RD., SUITE 545||MARIETTA|GA|30067||Lithotriptor, extracorporeal shock-wave,urological|HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/1998|07/14/1998|||APRL|Approval for non-synchronized shockwave delivery.
P840008|S063|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)|LNS|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/18/1998|06/19/1998|||APRL|Approval for revision of labeling regarding:  1) the risk of hypertension folloiwng renal lithotripsy, consistent with the conclusions of final postapproval study report (all models) 2) the maximum patient weight to be treated (HM4); and 3) additional safe treatment practices regarding non-ECG gated treatment (MFL 5000).
P860008|S016|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER|LPA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/1998|08/28/1998|||APPR|The device is indicated for 1) the termination of supraventricular tachycardia (atrial flutter and re-entrant atrial or atrio-ventricular paroxysmal tachycardias) in children via an esophageal catheter electrode; 2) the acceleration of heart rate in adults via a Pill-Electrode as an alternative to exercise during diagnostic studies such as echocardiography or radionuclide ventriculography; and 3) use in patients who develop bradycardia during general anesthesia and require acceleration of heart rate.
P860007|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH II MODELS 262-16|LWW|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/1998|07/06/1998|||APPR|Approval for alternate Polyethylene Terephthalate Glycol (PETG) packaging material for the Intetach II, Model 262-16 pulse generator.
P870036|S044|MEDTRONICS INTERVENTIONAL VASCULAR|3576 UNO CAL PLACE||SANTA ROSA|CA|95403||Catheters, transluminal coronary angioplasty, percutaneous|THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1998|11/17/1998|||APPR|Approval for a new product line.  The device, as modified, will be marketed under the trade name Medtronic(R) Achiever(TM) Coronary Balloon Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P860040|S015|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, extended wear|BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1998|03/04/1999|||APPR|Approval for a toric configuration of the BIOCURVE SOFT FW (methafilcon A) CONTACT LENS (clear and handling tint).  The device, as modified, will be marketed under the trade name BIOCURVE SOFT TORIC FW (methafilcon A) CONTACT LENS and is indicated for daily wear or extended wear by not-aphakic persons with non-diseased eyes.  The lenses are for the correct of refractive ametropia (myopia, hyperopia, and astigmatism).  The spherical lens may be worn by persons with up to 1.50 diopters of astigmatism that does not interfere with visual acuity; the toric lens corrects astigmatism of 5 diopters or less.  Lenses prescribed for extended wear may be worn from 1 to 7 days between removals for cleaning, rinsing, and disinfection or replacement, as recommended by the eyecare practitioner.  The lenses may be disinfected using a chemical disinfection system only.
P840008|S064|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/1998|06/05/1998|||APRL|Approval for changes to the therapy head positioning, modifications of the control panel, addition of a servicing modem, changes to the air flow within the device, material changes to the patient table, ECG monitor model replacement, change of the available X-ray features, software modifications, labeling changes, and integration of the water circulation device with its control computer.  The device, as modified, will be marketed under the trade name Dorneir Lithotripter S and is indicated for the fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelvic stones.
P910077|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/1998|07/31/1998|||APPR|Approval for an update to the Model 2881 Software Application to inlcude the DELTA/VISTA pacemakers series, resulting in Version 1.3 of the Model 2881 Software Application.
P910023|S033|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/22/1998|10/21/1998|||APPR|Approval of the Ventritex(R) Contour(R) MD Models V-175, V-175B, V-175C, V-175D and V-175AC and the Angstrom(TM) MD Models v-190F and V-190HV3.
P810046|S190|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX ESPRIT CORONARY DILATION CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/1998|07/30/1998|||APPR|Approval for additional balloon sizes for the ACS Avenger(TM) Coronary dilatation Catheter (quarter sizes within the range of 2.25-3.75 mm for the currently marketed 15mm and 20mm balloon lengths and half sizes in the rang eof 2.5-4.0mm for a 25mm balloon length.
P950014|S014|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/1998|06/09/1998|||APPR|Approval for an upgrade to the Prostatron's (TM) operating software to Prostasoft 4.0 (aslo referred to as "Prostasoft 98").
P890055|S007|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ARROW INTERNATIONAL MODEL 3000-50 ML CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/1998|01/11/1999|||APPR|Approval for the Arrow Model 3000-50 Constant Flow Implantable Pump for adults for the following indications: 1)the intraspinal delivery of preservative free morphine for patient with intractable chronic pain, 2) the intraspinal deliery of preservative free morphine for the treatment of pain ofmalignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.
P950019|S003|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY TFC DEVICE WITH INSTRUMENTATION (20MM)|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/1998|06/17/1998|||APPR|Approval for the addition of 20mm cages and modified labeling.
P950037|S002|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/1998|08/13/1998|||APPR|Approval for the Scan Hysteresis feature, Repetitive Hysteresis feature, and Night Mode feature associated with the PMS 1000 C Programmer, and the SWM 1000 F03.B00.U Software.  The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, and S models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U).  Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity.  Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrome (i.e., bradycardiatachcardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome.  Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes.  Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
P900060|S017|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/1998|06/11/1998|||OK30|Requested a modification in the type of biological indicator used in the sterility release of the Carbo-Seal AAP from the AMSCO Spordex Bacillus subtilis globigii spore strips to the 3M Healthcare Attest Bacillus subtilis globigii self-contained biological indicator.  The stzated reason for the change is to reduce the incubation period from seven to two days, and to reduce the change of operator error by eliminating the possibilitry of contaimination that may occur when spore strips in glassine envelopes are transferred to growth medium.
P880003|S075|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|NINJA PTCA DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/1998|12/11/1998|||APPR|Approval for the Cordis Ninja PTCA Balloon Dilatation Catheters.  The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis fo rth epurpose of improving myocardial perfusion.
P800068|S001|INSTRUMENTATION INDUSTRIES, INC.|1211 STREETS RUN RD.||PITTSBURG|PA|15236||Changer, tube, endotracheal|ENDOTRACHEAL TUBE CHANGER|LNZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/1998|07/23/1999|||APPR|Approval for the following changes:  1)Changes in manufacturing: a) new vendor for lumen extrusion; b) new vendor for imprinting the ink (reacted with a hardener) onto the tube changer; and c) eight additional sizes and three additional colors. 2) Change in labeling: a) change in the indications for use statement to reflect the eight new models; and b) revisions in the instructions for use.
P900052|S006|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST|LNY|HO|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/04/1998|09/15/1998|||APPR|Approval for a change in the postapproval protocol to allow the use of anesthetics or analgesics approved for epidural delivery when toxicity symptoms related to the use of preservative-free morphine develop or if there is inadequate pain relief.
P950037|S003|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/1998|08/13/1998|||APPR|Approval for the Scan Hysteresis feature, Repetitive Hysteresis feature, and Night Mode feature associated with the PMS 1000 C programmer, and the SWM 1000 F03.B00.U Software.  The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following:  Actros DR, D, SR, and S models, PMS 1000 Cprogrammer, SWM 1000 (Version F03.B00.U).  Rate adaptive pacing with the Actros DR and Actros SR pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity.  Generally accepted indications for long-term cardiac pacing include, but not limited to:sick sinus syndrom (i.e., bradycardiatachcardia syndrom, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome.  Patients who demonstate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes.  Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
P900043|S011|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/1998|06/29/1998|||APPR|Approval for a redesigned taper tip configuration of the Power Grip(TM) Delivery System.  The modification results in an increase in top length from 5 mm to 7 mm and a decrease in tip inner diameter from 0.020" to 0.016."
P870049|S027|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN(R) RAPID FLUOROGENIC PANELS|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/09/1998|06/30/1998|||APPR|Approval for the addition of a limitation to use an alternative method to confirm results for the testing of Staphylococcus spp. with the antibiotic Vancomycin.  The device, as modified, will be marketed under the trade name MicroScan(R) Rapid Fluorogenic.
P930038|S014|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/1998|11/25/1998|||APPR|Approval for the addition of printed markings to the outer surface of the insertion sheath.
P930012|S011|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES|LOX|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/1998|09/02/1998|||APPR|Approval for modifications to the Y-adapter, packaging and labeling of the LaCrosse(TM) PTCA Catheter, Wrap(TM) PTCA Cathter, Champion(TM) NC PTCA Catheter and Wrap(TM) NC PTCA Catheter product lines.
P880086|S047|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/1998|09/13/1999|||APPR|Approval for the Polarity Pulse Generator Models 2091K and 2091M/S.
P890003|S057|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/1998|07/14/1998|||OK30|Requested a change in the application pattern of the epoxy area that affixes the device battery to the insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.
P970012|S003|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/1998|07/14/1998|||OK30|Requested a change in the application pattern of the epoxy ara that affixes the device battery tot he insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.
P960001|S004|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|DEPUY 3 BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1998|07/13/1999|||APPR|Approval for a new bone cement formulation, in order to change the cement's handling characteristics.  The device is indicated for the fixation of prostheses to living bone in Orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.
P970044|S001|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/15/1998|06/23/1998|||APPR|Approval for the removal of the External INterstitial Thermometry System from the Urowave(R).
P840068|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/1998|07/31/1998|||APPR|Approval for an update to the Model 2881 Software Application to include the DELTA/VISTA pacemakers, series, resulting in Version 1.3 of the Model 2881 Software Application.
P910031|S019|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|THE ORACLE MEGASONICS FIVE-64 PTCA CATHER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/15/1998|12/11/1998|||APPR|Approval for modifications to the Endosonics Oracle MegaSonics Five-64(TM) PTCA Catheter.
P970012|S004|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/1998|09/22/1998|||APPR|Approval for Version .13 firmware which incorporates Automatic Polarity configuration (APC).
P810055|S070|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1998|07/15/1998|||APPR|Approval for a new test method and specification for ethylene oxide residuals prior to product release.
P880070|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL UV65 SERIES ANTERIOR CHAMBER LENSES|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1998|07/15/1998|||APPR|Approval for a new test method and specification for ethylene oxide residuals prior to product release.
P940031|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR PACEMAKERS, MODELS 460 AND 1130|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/1998|08/26/1998|||APPR|Approval for minor changes to the pacemaker top (header) and minor laeling changes for the Vigor SSI, Model 460 and Vigor SR, Model 1130.
P880086|S048|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/12/1998|07/14/1998|||APPR|Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer Software Model 3302 revision C (Paragon Version 1.03).
P830045|S057|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|APSU PROGRAMMER, APSU SOFTWARE, BASE STATION|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/12/1998|07/14/1998|||APPR|approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).
P860019|S146|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1998|08/10/1998|||APPR|Approval for the following additional models of the COYOTE(TM) PTCA Catheter:  a)the addition of 1/4 mm balloon diameter sizes from 2.25 mm to 3.75 mm for the 20 mm balloon length; b) balloon lengths of 9 mm, 15 mm, and 25 mm in balloon diameters of 2.5 mm to 4.0 mm in 1/4 mm increments; and c) balloon lengths of 20 mm and 40 mm in balloon diameters of 2.0 mm to 4.0 mm in 1/4 mm increments.  These PTCA catheter models are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.  The 2.5 mm - 5.0 mm balloon models are also indicated for ht epost-delivery expansion of balloon expandable stents.
P950032|S001|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/1998|07/09/1998|||OK30|The 30-day Notice requested a manufacturing process change fro Apligraf(TM).  The requested change will replace 8 laboratory-scale incubators currently used in the Apligraf(TM) manufacturing process, FORMA Steri-Cult 200, model #3033, with 6 production-scale incubators manufactured by Lunaire Corporation (model # CI0641W-6SPL).  The change will require a lower temperature setpoint in the Lunaire incubators during manufacturing.
P930038|S015|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/1998|12/11/1998|||APPR|Approval for modifications to the material used for the anchor component of the device.
P850022|S011|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK II BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/1998|07/14/1998|||APPR|Approval for the following modifications:1)The "tombstone" - No part Number a)Change of indication b)Minor grammatical corrections of labeling 2)The Physician Manual-Part Number 380-0001-0001-844 a)Change of indication b)Removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)Minor grammatical corrections of labeling 3)The Patient Manual - Part Number 380-0002-0001-844 a)change of indication b)removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)added the section "Electrode Retainers" (copied from Physician Manual) f)Minor grammatical corrections.  The indication change listed above in each section is as follows:  removal of the reference to a nine month clinical study time in the approved labels ("A non-union is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visible progressives signs of healing for a minimum of 3 months - no change in fracture callus") and to insert language as suggested in the FDA letter of June 3, 1998 ("A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing").  The device as modified, will be marketed under the trade name OrthoPak(R) and is indicated for treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where width of the defect is less than on-half the width of the defect is less than one-half the width of the bone to be treated.
P810046|S192|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX SOLARIS CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/1998|10/16/1998|||APPR|Approval for the ACS RX SOLARIS(TM) Coronary Dilatation Catheter and a modification to the Instructions for Use for ACS PTCA Catheters.  The ACS RX SOLARIS(TM) Coronary Dilatation Catheter is indicated for balloon dilatation of: 1) the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.
P960043|S008|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/22/1998|07/17/1998|||APPR|Approval for revised labeling and training materials including, the PVS Guidelines for post-procedural care and the training video entitled PVS Post Procedure Care.
P920023|S004|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT|UROLUME(TM)ENDOPROSTHESIS|MER|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/22/1998|07/15/1998|||APPR|Approval to: 1)increase the number or investigational sites in the post-approval study of new patients (post-approval study#2) under the recurrent bulbar urethral strictures application, and 2) increase the patient enrollment limit to 132 (to include 57 original and 75 new patients) for the post-approval study of the BPH application.
P900056|S024|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/1998|09/02/1998|||APPR|Approval to provide the Rotablator(R) RotaLink system to the user in a pre-connected configuration.  The device, as modified, will be marketed under the trade name Rotoblator(R) RotaLink Plus(TM) Rotational Angioplasty system and is indicated as a means of providng percutaneous rotational coronary angioplasty, as a sole therapy or with adjunctive balloon angioplasty, in patients with coronary artery disease who are candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria:  1) single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guide wire; 2) multiple vessel coronary artery disease that in the physician's judgment does not pose undue risk to the patient; 3) certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA), and who have a restenosis of the native vessel; or 4) native vessel atherosclerotic coronary artery disease that is less than 25mm in length.
P970035|S003|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1998|07/10/1998|||OK30|Requested a revision in the Installation Qualification (IQ) and Operational Qualification (OQ) validations for the Strain Relief Equipment, as well as a revision int he preventative maintenance procedure for Strain Relief Equipment to include monthly wire integrity verification.
P960001|S005|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|DEPUY 3 BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/1998|08/26/1999|||APPR|Approval for a manufacturing site located at DePuy International, Blackpool, Lancashire FY4 4QQ, England.
P850007|S022|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/1998|08/13/1998|||APPR|Approval for a modification to the definition of non-union in the labeling (i.e., a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).
P790005|S041|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/1998|07/24/1998|||APPR|Approval for revision of the indications and usage section ofthe labeling to include the definitiono f nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
P790002|S019|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM(R)|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/1998|07/27/1998|||APPR|Approval for revision of the indications and usage section of the labeling for Models 1200, 1020-S, 1026, and 101, to include the definition of nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
P930038|S016|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/1998|07/17/1998|||APPR|Approval for labeling changes intended to minimize the occurrence of vesse occlusion events associated iwth use of the device.
P840031|S009|LOMBART LENSES, LTD.|1215 BOISSEVAIN AVE.||NORFOLK|VA|23507||Lenses, soft contact, extended wear|LL-79 LIDOFILCON B (HYDROPHILIC) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/1998|07/09/1998|||OK30|The 30-day Notice requested that the device, which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
P960039|S001|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, extended wear|SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/1998|07/09/1998|||OK30|Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
P840008|S065|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER COMPACT DELTA|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/25/1998|07/07/1998|||APRL|Approval for changes tot he therapy head movement capabilities, alteration of the hand held control unit, modification of the X-ray range of movement, addition of an X-ray image storage feature, ECG monitor model replacement, replacement of the charging unit, a new mounting orientation for the ultrasound arm, design changes to the patient table, a new design for the phantom support accessory, software modifications, and labeling changes.  The device, as modified, will be marketed under the trade name Dornier Compact Delta Lithotripter and is indicated for fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelivc stones.
P810002|S047|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/1998|07/14/1998|||OK30|The 30 day requested approval for a PTFE fabric supplier change.
P900043|S012|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/1998|08/04/1998|||APPR|Approval for the indication of treatment of restenotic native coronary artery lesions with arefernce diameter in the range of 3-4 mm, and modifications ot the current albel that include addition ofthe Stars Trial results to the clinical summary section.
P910020|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/1998|08/06/1998|||APPR|Approval for modifications of the SideLock subsystem.
P950035|S002|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM(R)|GZC|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/29/1998|07/28/1998|||APPR|Application submitted to inform the Agency of the potential for device malfunction induced by electrostatic discharge and the changes being implementing to address the effects of ESD on the device.  The Special Supplement requested approval for revised manufacturing procedures, revised labeling for the clinician, and revised patient labeling.
P790020|S058|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/1998|07/09/1998|||OK30|Requested the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
P830026|S073|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/1998|08/06/1998|||APPR|Approval for modification of the SideLock subsystem.
P920023|S005|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT|UROLUME(TM)ENDOPROSTHESIS|MER|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/1998|07/07/1998|||APPR|Approval to add a new contraindication regarding fracture distraction defects of the posterior urethra to the labeling of the UroLume(R) stricture application.  Your supplement also requested approval to modify the labeling of the stricture and BPH applications to clarify that the UroLume(R) is not intended for temporary use.
P930029|S012|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/1998|08/14/1998|||APPR|Approval for a manufacturing site located at Medtronic Puerto Rico, Inc., Road 149, Km. 56.3, Villalba, Puerto Rico 00755.
P880086|S049|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1998|07/14/1998|||APPR|Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer Software Model 3302 Revision C (Paragon Version 1.03).
P830045|S058|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|APSU PROGRAMMER, APSU SOFTWARE, BASE STATION|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1998|07/14/1998|||APPR|Approval for software modifications to the APS III Programmer Software Model 3302 Revision B (Paragon Version 1.02) resulting in APS III Programmer software Model 3302 Revision C (Paragon Version 1.03).
P860019|S147|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/1998|08/06/1998|||APPR|Approval for changes to the instructions for use regarding the proper removal ofthe catheter from the packaging.
P970008|S007|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIC TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1998|07/07/1998|||APPR|Approval for the Targis(TM) Patient Comfort Kit which includes the MDS Holder and Knee Cusions.
P970044|S002|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/1998|07/10/1998|||APPR|Approval for a mobile/transportable Urowave(R).
P940031|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1998|07/24/1998|||APPR|Approval for a modification to the specification of the "runaway" rate for the above referenced families of pacemakers from 220+10% to 205+5%.
P950024|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1998|09/16/1999|||APPR|Approval for a new pacing lead model and is indicated for use with a pulse generator as part of a cardiac pacing system.  The lead has application where implantable epicardial atrial or ventricular, single or dual chamber pacing systems are indicated.
N50510|S082|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 SYSTEM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/1998|06/16/1999|||APPR|Approval for major modifications to the design of the device in order to automate manual operations and enhance its performance.  The device as modified will be marketed under the trade name VITEK(R) 2 System and is intended as a laboratory aid in the determination of the in vitro susceptibility of aerobic gram negative bacilli when tested on a Gram Negative Susceptibility Test Card.
P900009|S006|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000|LPQ|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/1998|02/22/2000|00M-0810||APPR|
P960001|S006|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|DEPUY 3 BONE CEMENT|LOD|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/1998|09/20/1999|||APPR|Approval for a change in the bone cement formulation to alter the handling characteristics.
P910066|S009|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/1998|07/14/1998|||APPR|Approval for marketing circular.
P830037|S041|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILLIC) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/1998|05/20/1999|||APPR|Approval for the DuraSoft(R) 3 UV (phemfilcon A) Spherical and Optifit Toric Clear, Handling Tint, Colors, and Color Complements Soft (hydrophilic) Contact Lens (lathe cut) for Extended Wear to incorporate the pigment carbazole violet as a handling tint at Wesley Jessen - Cidra Operation, Road 173, KM 1.1, Cidra, PR 00739.  The pigment will be incorporated as an in-monomer tint by entrapment.
P850035|S024|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/1998|04/07/1999|||APPR|Approval for labeling changes stating the device was MR Safe.
P940031|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/1998|10/02/1998|||APPR|Approval for changes to the Model 2890 Software Application from Version 1.20 to Version 2.12 which consist primarily of usability changes (screen changes, usability features), corrections of anomalies, and the addition of a high rate single chamber temporary pacing mode (up to 380 ppm) to the DISCOVERY(TM)/MERIDIAN(TM) pacemakers which provides consistency with the VIGOR pacemakers.
P970008|S008|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIC TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/09/1998|07/17/1998|||APPR|Approval for a change in the design of the capcitor used in the antenna within the MDS catheter.
P940011|S003|LUMENIS, INC.|3959 WEST 1820 SOUTH||SALT LAKE CITY|UT|84104|||COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS||SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/1998|11/24/1998|||APPR|Approval to relocate manufacturing facility from Coherent, Inc., 3270 W.Bayshore Rd., Palo Alto, CA to Coherent, Inc., 2400 Condensa St., Santa Clara, CA.
P940022|S006|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342|||CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE||EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/1998|09/04/1998|||APPR|Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following questioin and answer has been afixed to page 29:  "Are there any restrictions on physical activities with CLARION?"  "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity.  For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, sucha s using a protective helmet to reduce the risk of device failure."
P960058|S005|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE||EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/1998|09/04/1998|||APPR|Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following question and answer has been affixed to page 29:  "Are there any restriction on physical activities with CLARION?"  "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity.  For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, such as using a protective helmet, to reduce the risk of device failure."
N50510|S083|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD|LTW|MI|Normal 180 Day Track||N|07/09/1998|09/15/1998|N||APPR|Approval for the removal of a limitation for the testing of Pseudomonas aeruginosa with the antibiotic cefepime.
P960007|S008|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE|MGR|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/1998|08/14/1998|||APPR|Approval for changing the name of the product from Dermagraft-TC to TransCyte(TM) and for minor editoral changes to the Directions for Use and product label.  The device, as modified, will be marketed under the trade name TransCyte(TM) and is indicated for use as a temporary wound covering for sugically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
P930038|S017|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1998|09/25/1998|||APPR|Approval for modifications to packaging system components (i.e., insulated shipping container, ice pack, component tray and guidewire tray) of the Angio-Seal(TM) device.
P870072|S007|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/1998|07/20/1998|||OK30|Requested change in the supplier of the valves used to control the direction of blood flow in the Ventricular Assist Device.  The supplier will be changed from Sorin biomedical in Irvine, California to Arrow International in Reading Pennsylvania.
P790018|S033|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC(R) HALL PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/1998|08/06/1998|||APPR|Approval for relocation of manufacturing facility from Medtronic, Inc., Cardiovascular Business Center, Minneapolis, MN, to Medtronic, Inc., 8299 Central Ave., NE, Spring Lake Park, MN.
P930034|S012|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/14/1998|10/21/1999|00M-0424||APPR|Approval for the SVS Apex Plus Excimer Laser Workstation, emphasis(R) discs K and L, and axicon.  These devices are indicated to perform hyperopic PRK.
P950014|S015|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/1998|08/19/1998|||APPR|Approval for: 1) the use of an alternate thermometry system (Luxtron Model 3204), with related changes to the Prostaprobe and software; 2) the use of an upgraded microprocessor in the main computer; 3) a change of the material of several cabinet panels from metal to plastic; and 4) the addition of electromagnetic shielding to the cooling system regulation board.
P970051|S001|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/1998|09/21/1998|||APPR|Approval to strengthen the C124M implant case by adding a ceramic disc between the implant case and the ceramic feed through.
P970015|S001|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||NOVUS (TM) LC INTERBODY FUSION DEVICE||OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/1998|05/14/1999|||APPR|Supplement received prior to original approval.  This supplement was approved as part of the original approval order.
P870015|S030|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS-T TRANSPORTABLE LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/1998|09/16/1998|||APRL|Approval for a transportable configuration of the Medstone STS lithotripter.  The devices, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated for use in fragmentation of upper urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
P950032|S002|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Other Report|N|06/30/1998|01/06/1999|||APPR|Response to conditions of approval cited in May 22, 1998, Approval Order: 1)revisions in karyology, growth rate and morphology testing and 2)Protocol 98-VSU-002, "A Prospective Study to Determine the Longevity of Apligraf Cells on Patients with Venous Ulcers" as well as the cited methods for obtaining documentation on the viral inactivation processes for transferrin.
P970051|S002|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/1998|07/22/1998|||APPR|Approval for two minor design changes to the ESPrit (ear level) speech processor: 1) the addition of a 47uF capacitor; and 2) the lowering of the crystal Q with insertion of a low value resistor (R3-120).  As stated in the submission and described in the telephone conference on July 22, 1998, these two changes have been tested and validated.  With reference to item 1), this change would lower the total harmonic distoriton resulting in improved audio signal.  In item 2) you would improve the oscillator stability over a specified temperature range resulting in better production yield.
P950043|S005|MEDISPEC, LTD.|19110 MONTGOMERY VILLAGE AVE.|SUITE 100|MONTGOMERY VILLAGE|MD|20886||Lithotriptor, extracorporeal shock-wave,urological|ECONOLITH(TM) LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/1998|09/14/1998|||APRL|Approval for relocation of manufacturing facility from Medispec, Ltd., 28 Hacharoshet T., Or-Yehuda, Israel to Medispec, Ltd., 24 Hatasiya St., Yahud, Or-Yehuda, Israel.
P850007|S023|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/1998|08/14/1998|||APPR|Approval for the elimination of daily shut down after three hours ofuse and a change int he overall device lock-up time from 270 days to 365 days.
P880028|S008|Hospira, Inc.|275 NORTH FIELD DR.|DEPT. 389, BLDG. H2-2|LAKE FOREST|IL|60045||FLUID, HYSTEROSCOPY|DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM|LTA|OB|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1998|01/29/1999|||APPR|Approval for a change in the approved marketed product stability protocol for the Dextran HM 32% to delete 3 and 6 month test stations from the approved stability protocol.
P850020|S011|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA(TM) COLUMN|LKN|GU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/1998|03/15/1999|99M-0871|04/15/1999|APPR|Approval for the Prosorba(R) Column.  This device is indicated for: 1) use in the therapeutic removal of immunoglobulin G (IgG) and IgG-containting circulating immune complexes from plasma in patients with idiopathic thrombocytopenic purpura (ITP) having platelet counts less than 100,000mm3 and 2) for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients with long-standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
P960043|S009|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/1998|05/05/1999|||APPR|Approval for additional effectiveness claims (i.e., reduced time to ambulation and reduced time to discharge) for the Techstar(R) XL 6 Fr. Percutaneous Vascular Surgical (PVS) System.  The device will be marketed under the trade name Techstar XL 6F Percutaneous Vascular Surgical (PVS) System and is now indicated for:  "the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to ambulation (patient walks ten feet) of patients who have undergone diagnostic catheterization procedures using 5 Fr. to 6 Fr. sheaths.  The Techstar XL 6 Fr. PVS System reduces the time to discharge in patients having undegone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations)."
P910077|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6998 IS-1 LEAD PORT PLUG|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/19/1998|10/26/1998|||APPR|Approval for the model 6988 IS-1 Lead Port Plug.
P970036|S002|NIC LTD.|320 FAIRWAY DR.||HALF MOON BAY|CA|94019|||NIC2800 NEEDLE DISPOSAL SYSTEM||HO|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/1998|07/29/1998|||APPR|Approval to market a battery operated version of the NiC 1800 Needle Disposal System.  The device, as modified, will be marketed under the trade name NiC 2800 Needle Disposal System and is indicated for the disposal of standard plastic syring mounted hypodermic needles (19-28 gauge/up to 2" in length) in patient treatment and clinical laboratory settings.
N17600|S015|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1998|08/10/1998|||OK30|Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of Avitene MCH Flur, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.
P800002|S011|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/1998|08/10/1998|||OK30|Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of Avitene MCH Flour, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.
P830039|S008|MEDICALCV, INC.|9725 SOUTH ROBERT TRAIL||INVER GROVE HEIGHTS|MN|55077||HEART-VALVE, MECHANICAL|OMNISCIENCE AND OMNICARBON CARDIAC VALVES|LWQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/1998|09/25/1998|||APPR|Approval for modifications to various cleaning methods utilized during production of the Omniscience(R) valve to remove chlorofluorocarbon solvents.
P820083|S025|W.L. GORE & ASSOCIATES,INC|1500 N. FOURTH ST.|P.O. BOX 3000|FLAGSTAFF|AZ|86003||SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE|GORE-TEX(TM) SUTURE|GAW|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/1998|08/27/1998|||APPR|Approval for 1) a change in suture needle material 2) a change in suture needle geometry, and 3) addition of a silicone coating to the suture needle.
P970019|S003|HEALTH TRONICS SURGICAL SERVICES, INC.|425 FRANKLIN RD., SUITE 545||MARIETTA|GA|30067||Lithotriptor, extracorporeal shock-wave,urological|HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM|LNS|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/1998|11/18/1998|||APRL|Approval for modifications to the LithoTron(TM) Lithotripsy System's labeling to reflect the results of this final report.  Based upon the information submitted, FDA believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that this postapproval requirement is now considered complete.
P930012|S012|PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.|1350 WILLOW RD. SUITE 201||MENLO PARK|CA|94025||Catheters, transluminal coronary angioplasty, percutaneous|LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/1998|08/25/1998|||APPR|Approval for a change in labeling for the LaCrosse(TM) PTCA and Champion(TM) PTCA Catheter Product Lines.  Specifically, the change included a reduction in the labeled rated burst pressures for the 2.5mmx20mm, 3.0mmx30mm, and 3.5mmx30mm LaCrosse(TM) PTCA Catheters and the 2.0mmx20mm Champion(TM) PTCA Catheter.
P970038|S001|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY|MTG|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/1998|09/24/1998|||APPR|Approval for changes to the patient labeling.
P960007|S009|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE (DERMAGRAFT-TC)|MGR|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/1998|12/01/1998|||APPR|Approval that the ATP assay be used in place of the MTT assay as a means of monitoring and predicting product characteristics.  The product release criteria of the ATP assay stipulate that production lots of TransCyte will be harvested between incubation days 12 to 16 and must have an ATP value in the range of 0.083 to 0.127 moles per bioreactor to be considered an acceptable lot.
P950024|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/1998|02/01/1999|||APPR|Approval for a modified distal strain relief for the Model 4965 lead.
P950005|S003|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR|DRF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/27/1998|01/26/1999|||APPR|Approval for expanded indications for use for the 6 Fr and 7 Fr Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters and interface cables.  In addition to the previously approved indications for interruption of accessory AV conduction pathways associated with tachycardia, the treatment of AV nodal reentrant tachycardia (AVNRT), and creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia, your ablation system is now approved to treat patients with the following Indications for Use: 1) Pediatric Patients (age 4 years or older); 2) Patients with Persistent Junctional Reciprocating Tachycardia (PJRT); and 3) Patients with Mahaim Fibers.
P870076|S007|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM|KNH|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/1998|03/02/1999|||APPR|Approval for dimensional and design changes of the Falope-Ring(R) Applicators.
P840008|S066|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER COMPACT DELTA LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/1998|08/21/1998|||APRL|Approval for modifications to the X-ray module, changes to the device labeling, and approval of the mobile and transportable versions of the Compact Delta.
P940031|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/1998|08/21/1998|||APPR|Approval for modifications to the DISCOVERY and MERIDIAN pacemakers consisting of changes to the firmware to enhance the performance of existing diagnostic features, and a hardware change to the mixed mode integrated circuit chip to increase the maximum selectable pacing amplitude.
P910073|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1998|01/27/1999|||APPR|Approval for the Models 0144, 0145 and 0146 endocardial defibrillation leads.  The device, as modified, will be marketed under the trade name ENDOTAK(R) ENDURANCE (Rx(TM)) Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for VENTAK AICD automatic implantable cardioverter defibrillator systems.
P960001|S007|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|DEPUY 3 BONE CEMENT|LOD|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/1998|08/27/1998|||APPR|Approval for the inclusion of Endurance Bone Cement within a pre-packaged "kit" for cemented hip or knee replacement procedures.
P880086|S050|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1998|01/22/1999|||APPR|Approval for the Affinity DR Model 5330 L/R Dual-Chamber and Affinity SR Model 5130 L/R Single-Chamber Rate-Adaptive Pulse Generators with AutoCapture.  The devices, as modified, will be marketed under the trade Affinity DR Model 5330 L/R and Affinity Sr Model 5130 L/R and are indicated for rate-adaptive support pacing.
P830045|S059|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|APS III PROGRAMMER WITH MODEL 3303 SOFTWARE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1998|01/21/1999|||APPR|Approval for the Model 3303 Software version 1.01 for use with the APS III Model 3500 Programmer.
P940007|S004|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|SILICONE POSTERIOR CHAMBER INTRACULAR LENSES         IOL MODEL 127(920)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1998|09/29/1998|||APPR|Approval for a manufacturing site located at Pharmacia & Upjohn Groningen BV, Van Swietenlaan 5, NL-9728, NX Groningen, The Netherlands.
P970004|S003|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/1998|11/02/1998|||APPR|Approval for marketing the Medtronic(R) Model 3057 Test Stimulation Lead Bulk Accessory/Medtronic(R) Model 3065U Test Stimulation Lead Kit for use with the Medtronic(R) Interstim(R) Continence Control System which is inidcated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.
P960043|S010|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/03/1998|12/21/1998|||APPR|approval to expand the range of users of the Prostar(R) and Techstar(R) PVS systems to inlcude healthcare professionals other than physicians.
P950029|S001|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1998|12/22/1998|||APPR|Approval for functional changes to reduce size and update algorithms and features in previously approved Chorus RM Model 7034 and Opus RM Model 4534.  The device, as modified, will be marketed under the trade name Brio and is indicated for: The generally accepted patient conditions warranting chronic cardiac pacing which include:  1) Symptomatic paroxysmal or permanent second or third-degree AV block; 2) Symptomatic bilateral bundle branch block; 3) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conductions disorders; 4) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomaitc tachyarrhythmias; and 5) Vaso-vagal syndrome or hypersensitive carotid sinus syndromes.  The Brio is also indicated for dual-chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony.  Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony which include: 1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.
P840068|S037|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/1998|08/26/1998|||APPR|Approval for minor changes to the pacemaker top (header) and minor labeling changes for the Vigor SSI, Model 460 and Vigor SR, Model 1130.
P820012|S006|Integra LifeSciences Corp.|22 TERRY AVENUE||BURLINGTON|MA|01803||MONITOR, INTRACRANIAL PRESSURE, IMPLANTED|COSMAN ICP TELE-SENSOR(R)|LII|NE|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/1998|07/29/1999|||APPR|Approval for the addition of a polypropylene connector to the ventricular catheter side of the Tele-Sensor(R).
P950027|S002|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN(R)|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/1998|12/18/1999|||APPR|Approval for modification of labeling to be modified and to add the information about the current clinical experience of the device as detailed in the amendment of 12/10/99.
P860003|S031|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1998|08/10/1999|||APPR|Approval for engineering changes to the UVAR(R) Photopheresis System including the following:  1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centrifuge assembly that includes an optical detector; 2) Replacing the electronic roller pumps and mechanical clamps with a pneumatically-driven fluid management system, including the cassette, fluid logic module and fluid logic controller; 3) Modifying the Photoceptor(R) photoactivation chamber; 4) Redesigning the treatment kit; and 5) Redesigning the user interface and system software.  The device is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug methoxsalen (8-methoxypsoralen or 8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy.
P970061|S001|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/10/1998|02/04/1999|||APPR|Approval for a modification ot the indications statement to include the treatment of saphenous vein graft lesions.  The SCIMED RADIUS(TM) Coronary Stent (14 mm and 20 mm lengths) with Delivery System is indicated for use in patients with symptomaitc ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diamter ranging from 2.75 to 4.25 mm and is intended to improve coronary luminial diameter.
P810046|S193|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX GEMINI CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/1998|12/22/1998|||APPR|Approval for the ACS RX Gemini Coronary Dilatation Catheter.
P870013|S009|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1998|05/13/1999|||APPR|APPROVAL FOR A MANUFACTURING AND STERILIZATION FACILITY LOCATED AT BAUSCH & LOMB SURGICAL, INC., CLEARWATER, FLORIDA.
P790027|S060|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1998|05/13/1999|||APPR|APPROVAL FOR A MANUFACTURING AND STERILIZATION FACILITY LOCATED AT BAUSCH & LOMB SURGICAL, INC. CLEARWATER, FLORIDA.
P910061|S003|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1998|03/08/1999|||APPR|Approval for a manufacturings qualification protocol and a manufacturing site located at 21 Park Place Blvd., N., Clearwater, FL 33759.
P910023|S034|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CONTOUR(R) II/ANGSTROM(TM) II ICD SYSTEMS|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/1998|10/22/1998|||APPR|Approval for a manufacturing site located at St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, Ca 91342-3577.
P930031|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/12/1998|07/21/1999|||APPR|Approval for labeling changes and claims for MRI compatibility for the Wallstent(R) TIPS Endoprosthesis.
P970061|S002|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM||CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|08/13/1998|04/21/1999|||APPR|Proposal for 5 year post-approval study protocol.
P850059|S017|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/1998|05/13/1999|||APPR|APPROVAL FOR A MANUFACTURING AND STERILIZATION FACILITY LOCATED AT BAUSCH & LOMB SURGICAL, INC., CLEARWATER, FLORIDA.
P940034|S007|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121|||GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)||MI|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|08/17/1998|09/02/1999|||APPR|Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents.  The supplement included a protocol for assessing effectiveness of user controls with rRNA controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for P940034/S004.
P900056|S025|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Other Report|N|08/14/1998|02/09/1999|||APPR|Approval for the validation protocol for the extended three year shelf life for the BSC Northwest guide wires.
P840024|S076|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1998|11/19/1998|||APPR|Approval for modifications to the device to use silicone materials supplied by two new vendors (NuSil Technology and Applied Silicone).
P890027|S045|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1998|11/19/1998|||APPR|Approval for modifications to the device to use silicone materials supplied by two new vendors.
P970051|S003|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1998|11/19/1998|||APPR|Approval for modifications to the devie to use silicone materials supplied by two new vendors.
P970020|S005|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/1998|02/18/1999|||APPR|Approval to add the indication for abrupt or threatened abrupt closure to the product labeling for the ACS Multi-Link(TM) (OTW, RX HP(TM), and OTW HP(TM)), ACS Multi-Link RX, ACS Multi-Link (RX and OTW) Duet(TM) Coronary Stent Systems (CSS); and approval for additional stent sizes for the ACS Multi-Link RX (stents with 2.5 mm diameter or 35 mm length) and ACS Multi-Link (RX and OTW) Duet(TM) (stents with 2.5 mm diameter or 38 mm length)CSS.  These devices are indicated for use as follows: The ACS Multi-Link(TM) OTW, RX HP(TM), and OTW HP(TM) CSS is indicated for use in patients with symptomatic ischemic heart disease: due to discrete de novo native coronary artery lesions (length < 20 mm) with a reference vessel diameter ranging from 3.0 mm to 3.75 mm; due to discrete restenotic native coronary artery lesions (length < 20mm) with a reference vessel deameter ranging from 3.0 mm to 3.75mm; presenting with abrupt or threatened abrupt closure of native coronary arteries (lesion length < 20mm) with a reference vessel diameter ranging from 3.0mm to 3.75mm); and is intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present.  The ACS Multi-Link(TM) RX CSS is indicated for use in patients with symptomatic ischemic heart disease: due to discrete de novo native coronary artery lesions (length < 22mm) with a reference vessel diameter raning from 3.0mm to 3.5mm; due to discrete restenotic native coronary artery lesions (length <22mm) with a reference vessel diameter raning from 3.0mm to 3.5mm; presenting with abrupt or threatened abrupt closure of native coronary arteries (lesion length <32mm) with a reference vessel diameter raning from 2.5mm to 3.5mm; and is intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present. Note: The 2.5mm diamter and 35mm length stents are indicated solely for use in patients with abrupt or threatened
N50510|S084|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 SYSTEM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/1998|06/28/1999|||APPR|Approval for the addition of four antibiotics to the Gram Positive Susceptibility Card.  The device as modified will be marketed under the trade name VITEK(R) 2 System and is intended as a laboratory aid in the determination of the in vitro susceptibility of aerobic gram positive bacteria when tested on a Gram Positive Susceptibility Test Card with specific antimicrobial agents and concentrations.
P950019|S004|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY TFC DEVICE WITH INSTRUMENTATION|MAX|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/18/1998|08/27/1998|||APPR|Approval for modified labeling and labeling procedures for the instruments.
P970061|S003|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1998|09/15/1998|||APPR|Approval for a manufacturing site located at Scimed Life Systems, One Scimed Place, Maple Grove, Minnesota.
P950022|S003|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|SPL TRIPOLAR, TINED TRANSVENOUS DEFIBRILLATION LEADS|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/1998|10/22/1998|||APPR|Approval for a manufacturing site located at St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA  91342-3577
P910066|S011|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR|LOF|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/20/1998|12/17/1999|00M-1073||APPR|Change to the indications for use and will be marked under the tradename SpinaLogic.
P900056|S026|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/1998|09/16/1999|||APPR|Approval for the RotaGlide(TM) Lubricant.
P880086|S051|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFFINITY DR & AFFINITY SR PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1998|01/21/1999|||APPR|Approval for the Model 3303 Software version 1.01 for use with the APS III Model 3500 Programmer.
P970019|S004|HEALTH TRONICS SURGICAL SERVICES, INC.|425 FRANKLIN RD., SUITE 545||MARIETTA|GA|30067||Lithotriptor, extracorporeal shock-wave,urological|LITHOTRON ULTRA LITHOSTRIPSY SYSTEM|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/1998|09/11/1998|||APRL|Approval for the following modifications to the LithoTron(TM) Lithotripsy System: 1) replacement of the transportable C-arm fluoroscopy system with an upgraded, stationary x-ray imaging system, 2) replacement of the existing patient table with one that offers Trendelenburg positioning, and 3) the addition of motorized movement of the shock wave therapy head.  The device is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.
P910061|S004|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODELS L15IU AND L16IU|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/18/1998|10/02/1998|||APPR|Approval for a change in the raw material specifications for SOFLEX IOLs.
P860019|S149|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/1998|05/28/1999|||APPR|Approval requested for the SCIMED REMEDY Coronary Balloon Dilatation Infusion Catheter .  The device is indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion , and to infuse fluids such as heparinized saline, and thrombolytic agents such as urokinase, into the vasculature when the dilatation balloon is deflated or inflated to pressures up to 3 atm.  The REMEDY catheter (2.5 - 4.0 mm balloon diameters)is also indicated for the post-delivery expansion of balloon expandable stents.
P940010|S005|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC|MVG|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/1998|11/23/1998|||APPR|Approval for commerical distributing of the modified DCYL Cylindrical Fiber Optics which incorporate a glued diffusing tip in place of the previously approved threaded tip.  The device, as modified, will be marketed under the trade name OPTIGUIDE Cylindrical Fiber Optic (DCYL2 Diffuser Series and is indicated for:  palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinon of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy, and treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.
P960058|S006|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1998|09/05/2000|||APPR|APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT WITH THE ELECTRODE POSITIONER FOR PEDIATRIC USES.
P940022|S007|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342|||CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1998|12/23/1999|||APPR|Approval for the CLARION Multi-Strategy Cochlear Implant (Adult) Electrode Positioner.
P950027|S003|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN(R)|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/1998|12/18/1999|||APPR|Approval for modification of labeling and additional information about the current clinical experience of the device as detailed in amendment received 12/10/99.
P980001|S001|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PRIMO PREMOUNTED STENT SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1998|05/20/1999|||APPR|Approval  for the NIR Primo Premounted Stent System.
P910001|S014|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|VITESSE-C OS CATHETER MODELS 114-009, 117-016, AND 120-009|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1998|01/28/2000|||APPR|Approval is for the Vitesse-C OS Laser Angioplasty Cathethers, Models 114-009, 117-016, and 120-009.
P970012|S006|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC VISION SOFTWARE MODEL 9952-SERIES 2.1 AND MEDTRONIC. VISION SOFTWARE MODEL 9952A-SERIES 2.1|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/1998|10/15/1998|||APPR|Approval for software changes to the Medtronic.Vision Model 9952 Series 2.1 and 9952A Series 2.1 Software.
P950029|S002|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/1998|10/09/1998|||APPR|Approval for the new Model CPR1D Programmer Head.
P940013|S006|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|PRECISION(TM) UV (VASURFILCON)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1998|01/07/1999|||APPR|Approval for modifications to the labeling, including an additional indications statement, "Precision UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye"; and modified Note and Warning as stated below:  "Warning: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area.  You should continue to use UV-absorbing eyewear as directed."
P860003|S032|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/26/1998|09/01/1998|||APPR|Approval for a labeling change to include a natural rubber latex caution statement in the labels for the Photopheresis Procedural Kit, the Photoactivation Line, and the Photopheresis Procedural Kit Carton.
P910023|S035|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|VENTRITEK CONTOUR II TIERED THERAPY IMPLANTABLE DEFIBRILLATOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/1998|09/03/1998|||APPR|Approval for a modification of the defibrillation ports of the Ventritex(R) Contour(R) II Model V-185D Implantable Cardioverter Defibrillator (ICD).
P830079|S012|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1998|05/05/1999|||APPR|Approval for an additional location for final product release located at Ethicon, Inc., U.S. Route 22, Somerville, NJ 08876 and duplication of final packaging process at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico 00754.
P960057|S001|WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1998|09/11/1998|||OK30|The 30-day Notice requested that FDA review a change in the manufacturing process.  A Vertrod Thermal Impulse Heat Sealer will be used in place of an Audion Future Jaw clamp pouch sealer to seal the Tyvek pouch containing the aluminum tube of ADCON(R)-L Adhesion Control Barrier Gel.  This change does not affect the currently approved Tyvek seal integrity testing method or specification.
N12159|S017|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1998|05/05/1999|||APPR|Approval for an additional location for the final product release located at Ethicon, Inc., U.S. Route 22, Somerville, NJ 08876 and duplication of final packaging process at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico 00754.
P880047|S006|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED  ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/1998|05/05/1999|||APPR|Approval for a manufacturing site located at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico.
P960028|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/1998|02/24/1999|||APPR|Approval for changes to the physician and patient labeling.
P850064|S014|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER|LSZ|AN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/1998|09/16/1998|||APPR|Approval for the addition of a caution to the labeling.
P950037|S004|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/1998|09/24/1998|||APPR|Approval for a slightly downsized header for the Actros DR, D, SR, and S pulse generators as well as approval for the Actros DR-A which is compatible with 5-mm leads and the Actros SR-B which is compatible with 6-mm leads.  The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, S, DR-A, and SR-B models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U).
P960011|S001|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/1998|09/09/1998|||APPR|Approval for Akorn, Inc. to distribute BioLon(TM) in the United States.
P830061|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSURE SP MODEL 4523M|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1998|10/09/1998|||APPR|Approval for removing the platinum sputtering from the conductor coil of the device.
P960058|S007|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)||EN|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/1998|02/19/1999|||APPR|Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium.
P940022|S008|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342|||CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE||EN|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/1998|02/19/1999|||APPR|Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium.
P890017|S005|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/1998|09/25/1998|||OK30|The 30-day notice requested that FDA review a change involving the transfer of an intermediate manufacturing process.  The electropolishing of the metal stent and post-polishing stent inspection operation will be transferred from Corids Corporation to one of the suppliers, Norman Noble, Inc. of Cleveland, Ohio.
P940034|S008|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121|||GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST||MI|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/04/1998|09/30/1999|00M-0578|02/15/2000|APPR|This device, a target-amplified nucleic acid probe test, is indicated for: the in vitro diagnostic detection of Mycobacterium tuberculosis complex rRNA in acid-fast bacilli (AFB) smear positive and negative concentrated sediments prepared from sputum (induced or expectorated), bronchial specimens (e.g., bronchalveolar lavages or bronchial aspirates) or tracheal aspirates.  The MTD test is intended for use only with specimens from patients showing signs and symptoms consistent with active pulmonary tuberculosis.  MTD is to be used as an adjunctive test for evaluating either AFB smear positive or negative sediments prepared using NALC-NaOH digestion-decontamination of respiratory specimens.  Patients who are suspected of having pulmonary TB based on clinical evaluation and who have received no antituberculous therapy, less than 7 days of such therapy, or have not received such therapy in the last 12 months may be evaluated with this test.  The MTD test should be performed only in laboratories proficient in the culture and identification of M.tuberculosis (Level II and III or extent 3 and 4).  The MTD test must be performed in conjunction with mycobacterial culture.
P970061|S004|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/04/1998|09/25/1998|||APPR|Approval for revisions to the Instructions for Use.
P970061|S005|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||SCIMED RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/08/1998|02/11/1999|N||APPR|Approval for a Single-Operator Exchange (SOE) Delivery System for the SCIMED(R) RADIUS(TM) Stent.  The device, as modified, will be marketed under the trade name SCIMED(R) RADUS(TM) Coronary Stent with Single-Operator Exchange (SOE) Delivery System and is indicated for use in pateitns with symptomatic ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diameter ranging from 2.75 to 4.25mm and is intended to improve coronary luminal diameter.
N50510|S085|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 SYSTEM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/1998|07/09/1999|||APPR|Approval for the addition of three antibiotics to the Gram Positive Susceptibility Card.  The device is intended as laboratory aid in the determination of the in vitro susceptibility of aerobic gram positive bacteria when tested on a Gram Positive Susceptibility Test Card with varioius antimicrobial agents and concentrations.
P900070|S023|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|TEMPO AND META PULSE GENERATORS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/1998|10/15/1998|||OK30|The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
P830045|S060|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|PARAGON II AND PHOENIX PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/1998|10/15/1998|||OK30|The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
P880006|S028|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/1998|10/15/1998|||OK30|The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
P880086|S052|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY, SOLUS, PHOENIX, PARAGON AND TRILOGY FAMILY OF PULSE GENERATORS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/1998|10/15/1998|||OK30|The 30-day Notice requested use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
P910077|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI ACID FAMILY SYSTEMS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/10/1998|12/02/1998|||APPR|Approval for VENTAK(R) MINI(TM) IV Models 1790, 1792, 1793, and 1796; VENTAK(R) MINI(TM) III+HE Models 1788 and 1789; VENTAK(R) MINI(TM) Application Software Model 2840 (Version 4.0); and the sensitivity adjustment for VENTAK(R) MINI(TM) and MINI(TM) II ICD systems.
P900022|S005|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|CHORUS PACEMAKERS|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1998|11/18/1998|||APPR|Approval for a sterilization site located at Griffith MicroScience S.A., 8 rue Parmentier, 60290 Rantigny, France
P880086|S053|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/1998|10/21/1998|||APPR|Approval for the APS III Model 3500 Programmer Software Revision D (version 1.04)
P830045|S061|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/1998|10/21/1998|||APPR|Approval for the APS III Model 3500 Programmer Software Revision D (version 1.04).
P830055|S060|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/1998|11/10/1999|||APPR|Approval for gas plasma sterilization of the porous coated rotating patella components of the LCS Total Knee System.
P970015|S002|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||NOVUS TM LC THREADED INTERBODY FUSION DEVICE (TIBFD)||OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/1998|05/14/1999|||APPR|Supplement received prior to original approval.  Supplement approved as part of the original approval order.
P940019|S004|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT ILIAC ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/14/1998|03/30/1999|||APPR|Approval for labeling changes related to MRI claims.
P810020|S005|SMITH & NEPHEW RICHARDS, INC.|1450 BROOKS RD.||MEMPHIS|TN|38116||BONE CEMENT|OSTEOPAL|LOD|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/1998|10/15/1998|||APPR|Approval for changes to Osteopal's package insert.
P970003|S010|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/1998|09/25/1998|||OK30|30-day notice requested the addition of a cleanroom equivalent to one already in use.
P950029|S003|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|OPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/1998|11/18/1998|||APPR|Approval for a sterilization site located at Griffith MicroScience S.A., 8 rue Parmentier, 60290 Rantigny, France.
P930016|S008|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)|LZS|OP|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|09/15/1998|02/23/1999|||APPR|Approval to consider report of the postapproval studies a final report and to discontinue all PRK postapproval study requirements.  The Model C(STAR) device, as modified in supplement 7, will be marketed under the trade name VISX STAR S2 Excimer Laser System and is indicated for the treatment of myopia, astigmatism and hyperopia (sphere only).
P960030|S003|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/1998|10/15/1998|||OK30|The 30-day Notice requested approval for use of parametric release as ana lternate to the current use of biological indicators in the releae of sterilized products.
P960013|S004|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL DX ENDOCARDIAL PACING LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/1998|10/15/1998|||OK30|The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
P960028|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR (IOL)|MFK|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/1998|06/08/1999|||APPR|Approval to expand the diopter range of the ARRAY(R) IOL from 16-24D to 6-30D in half diopter increments.
P840024|S077|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|AUDALLION BEAMFORMER|MCM|EN|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/1998|09/25/1998|||APPR|Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default.  With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejction of the overall RF interference.  For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge.  Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available procesor settings on the Audallion, enabling the device to be more user friendly.
P890027|S046|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|AUDALLION BEAMFORMER|MCM|EN|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/1998|09/25/1998|||APPR|Approval of four minor design changes to the Audallion Beamformer Noise Reduction System:  1) switch on/off circuit improvements, 2) replacement of the LC filter with an RC filter, 3) battery spring design change, and 4) a minor software change pertaining to the volume default.  With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion.  Regarding item 2), the RC filter will improve the rejection of the overall RF interference.  For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge.  Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available processor settings on the Audallion, enabling the device to be more user friendly.
P960030|S004|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/1998|10/08/1998|||OK30|The 30-day Notice requested that FDA review a change in material from ETR and MDX silicone rubber to liquid silicone rubber, and a change in the manufacturing process, from transfer molding to liquid injection molding, using an approved vendor.  These changes apply to the fins, tines, and suture sleeve components of the Passive Plus(R) Endocardial Pacing Leads.
N18286|S010|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM STERILE SPONGE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/1998|10/14/1998|||OK30|The 30-day Notice request the addition of a new packaging machine (Doyen) to package/seal the outer envelope (primary sterile barrier) of the Gelforam(R) sterile sponge.  The addition of the new packaging machine resulted in other hcange that included a new paper vendor and a change in the application of the adhesive pattern on the package.  The label copy will be printe don line and no longer supplied by the paper vendor; and the smallest Gelfoam(R) package size, 12-7 (3"x71/2") was changed to 4"x71/2" due to limitations of the Doyen packaging machine.  As  a result of this packaging size change, the sterilization process was validated successfully.  A UV decontamination procedure was also incorporated into the Standard Operating Procedure for Container Closure Integrity testing to minimize the risk of th false-positive results during sterility testing.  The added packaging equipment will be used as the primary packaging line, while the ucrrent packaging equipment (Circle) will be used as an alternate.
P980001|S002|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR ON RANGER PREMOUNTED STENT SYSTEMS||CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|09/14/1998|08/03/1999|||APPR|Approval for the postapproval study protocol for the NIR ON(TM) Ranger w/SOX(TM) and NIR ON(TM) Ranger(TM) Premounted Stent Systems.
P880003|S077|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CHARGER PTCA DILATION CATHETERS|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/1998|11/16/1998|||APPR|Approval for the 18mm and 25mm length Charger PTCA catheters with 3.0mm, 3.5mm and 4.0mm balloon diameters.  The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P880091|S015|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, TORIC OPTICS|ELASTIC AND ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES|MJP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/1998|03/15/1999|||APPR|Approval for a modification to the manufacturing process.
P900060|S018|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|SULZER CARBOMEDICS ORBIS PROSTHETIC HEART VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/18/1998|03/17/1999|||APPR|Approval for a sewing cuff modification of the CarboMedics(R) Prosthetic Heart Valve.  The device, as modified, will be marketed under the trade name Sulzer Carbomedics Orbis(TM) Prosthetic Heart Valve and will be available in the following model numbers and sizes:  Model 100 (aortic sizes 19, 21, 23, 25, 27, 29, and 31mm), and Model 200 (mitral sizes 21, 23, 25, 27, 29, 31, and 33mm).
P970035|S005|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/1998|09/30/1998|||OK30|Requested a change to utilize a circular "ring" light source to apply the UV light during the UV adhesive curing process.  The requested change will provide constant 360 degree application of UV light to the UV adhesive and will no longer require rotation of the catheter assembly.  This process change will eliminate the need for nitrogen cooling gas and will reduce the process time for the distal luer bond from 60 seconds to 38 seconds.
P970035|S006|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|09/21/1998|04/27/1999|||APPR|Approval for the 5-year post-approval study protocol for the Micro Stent(R) II and GFX(TM) Over-the-Wire Coronary Stent Systems.
P970035|S007|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1998|09/30/1998|||OK30|Requested a change in the current balloon bond process from a manual to an automated process.
P910066|S012|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC 1000 SC|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/1998|10/16/1998|||APPR|Modifications to the sizes of the device.  The device, as modified, will be marketed under the trade name Orthologic 1000-SC and is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones.  A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
P850007|S024|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/1998|11/03/1998|||APPR|Approval t use a smaller gauge wire for the Transducer Coil, change from PVC to Neoprene for the inside and outside covers of both front and rear transducer coils, and slightly reduce the thickness of the Kydex material.  The device will be marketed under the trade name Spinal-Stim(R) and is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
P950015|S001|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|THE HEART LASER CO2 TMR SYSTEM|MNO|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|09/21/1998|10/06/1998|||APPR|Approval for the post approval clinical study to be conducted as a condition of approval.
P950037|S005|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|KAIROS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/26/1998|11/19/1998|||APPR|Approval for the Kairos family of pulse generators with B-G00.0.U Programmer Software for use with the Model 1000/1000C Programmers. As a discrete subset of the approved Actros family of pulse generators, the Kairos family is approved for the same indications.
P970012|S008|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 400 SERIES IPG'S|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/1998|03/12/1999|||APPR|Approval for a manufacturing site located at Medtronic Europe S.A., Route de Molliau, Tolochenaz, Switzerland and a final packaging site located at Medtronic B.V., Kerkrade, Wenckebachstraat 10, 6466, Postbus, 1013-6460 BA, Kerkrade, The Netherlands.
P920023|S006|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESIS|MER|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/1998|10/02/1998|||APPR|Approval for the addition of a warning to the device labeling to reflect an unexpected adverse event.
P950014|S016|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/1998|10/14/1998|||APPR|Approval for modifications to the Prostatron's(R) labeling which summarize the results of the postapproval study.
P920015|S015|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT MODELS 6943/6945|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/1998|11/23/1998|||APPR|Approval for a manufacturing and sterilization site located at Medtronic Puerto Rico, Inc., Villalba West Industrial Area, Villalba, Puerto Rico 00766.
P940015|S001|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC (HYLAN G-F 20|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/29/1998|11/05/1998|||APPR|Approval for labeling changes, including addition of the statement:  "The packaging of this product contains dry natural rubber latex."
P970058|S001|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/1998|10/21/1998|||APPR|Approval for design changes that relocate the SCSI, support a new paper printer, correct several minor bugs and add minor operational enhancements.
P900070|S024|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|TEMPO FAMILY OF PULSE GENERATORS|DXY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/1998|10/29/1998|||APPR|Approval for an extension of product shelf life from 12 months to 18 months.
P880086|S056|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TRILOGY FAMILY OF PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/02/1998|11/03/1998|||APPR|Approval for a change in the insulating ring surrounding the negative pin of the battery in Trilogy pacers.
P970003|S011|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/1998|10/16/1998|||OK30|The 30-day Notice requested that a welding process be added to the firms' internal manufacturing capabilities.  This process is equivalent to the welding process already performed by Cyberonics' subcontractors.  The process is being brougth in-house in order to simplify the manufacturing process, improve control of product flow, and improve product availability.
P970058|S002|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER M1000 SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/1998|01/16/1999|||APPR|Approval for new software that significantly reduces extraneous marks while providing a modest increase in sensitivity for detecting of masses.
N18466|S023|DEPUY, INC.|P.O. BOX 988||WARSAW|IN|46581|0988|BONE CEMENT|ORTHOSET BONE CEMENT|LOD|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/1998|10/21/1998|||APPR|Approval to remove the ascorbic acid and ethanol components from the liquid monomer formulation in your Orthoset 1, Orthoset 2, and Orthoset 3 bone cements, as well as approval to omit the quality control test for dimensional change from the finished product specification.
P850089|S040|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE SP NOVUS|DTB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/1998|10/29/1998|||APPR|Approval for distribution under a new trade name.  The devices will be marketed under the trade name Vitatron(R) Excellence SS+ Models IML 49B and IML 49JB and indicated for use with pulse generators as part of a caridac pacing system to provide chronic pacing and sensing of the ventricle.
P840001|S042|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|DUAL CHANNEL ITREL SYNERGY NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/1998|11/19/1999|||APPR|Approval for the Dual Chamber Intrel(R) Synergy(TM) Neurostimulation System as well as the Model 7459 MemoryMod Software for use with the existing Itrel(R) 3 Spinal cord Stimulation System.
P920023|S007|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT,URETHRAL,EXTERNAL SPHINCTER,PERMANENT|UROLUME ENDOPROSTHESIS|MXQ|GU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/1998|03/29/1999|99M-0870|04/15/1999|APPR|
P970031|S007|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/1998|10/30/1998|||OK30|The 30-day Notice requested a change in the method in which a raw material (AOA compound) is synthesized.  This will result in the raw material being received in a more purified form.  The quality control test performed in incoming inspection will change from the Gravimetric test method to the Ninhydrin test method.
P960043|S011|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR XL & PROSTAR XL PERCTANEOUS VASCULAR SURGICAL DEVICE||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1998|04/09/1999|||APPR|Approval for a modification to the suture lumen.
P910023|S036|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE (R) TIERED THERAPY DEFIBRILLAATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1998|11/04/1998|||APPR|Approval for the Ventritex(R) Profile(TM) II Tiered-Therapy Defibrillator System (Models V-184F and V-184HV3), Profile(TM) MD Tiered-Therapy Defibrillator System (Models V-186F and V-186HV3), Model 1500 Programmer Application Software Version 5.2, and Test Can Model AC-PFL-TCN.
P860019|S150|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/1998|04/08/1999|||APPR|Approval for the SCIMED NC MAXXUM(TM) PTCA Catheter (20mm balloon length with balloon diameters of 2.0mm, 2.5-4.0mm in 1/4mm increments and 4.5mm, -5.0mm in 1/2mm increments; and 9mm and 15mm lengths with balloon diameterrs of 2.5-4.0mm in 1/4mm increments and 4.5mm - 5.0mm) in 1/2mm increments.  The NC MAXXUM(TM) PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or byapss graft stenosis for th epurpose of improving myocardial perfusion.  The NC MAXUUM(TM) PTCA Catheter (balloon models 2.5-4.0mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.
P920047|S010|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/1998|04/14/1999|||APPR|Approval for an alternate contract sterilizer and a change of biological indicator.
P850049|S006|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER|DTK|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/1998|12/21/1998|||APPR|approval for a change to the packaging.
P960006|S001|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/1998|04/09/1999|||APPR|Approval for several new lead models:  the SWEET PICOTIP(TM) Rx Models 4050, 4051, 4052, 4053, 4054, and 4055 Steroid Eluting, Positive-Fixation, Porous Tip Pacing Leads.  These devices are indicated for chornic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
P960009|S003|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/1998|09/30/1999|||APPR|Approval for the Model 3389 DBS(TM) Lead (as an alternative tot he existing Model 3387 DBS(TM) Lead) for use in conjunction with the existing Medtronic Activa Tremor Control System.
P970035|S008|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|GFX-XP/GFX2 CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1998|04/08/1999|||APPR|Approval for the Medtronic AVE GFX(R) 2 Over-The-Wire Coronary Stent System.  The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length < 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm.  Long term outcome (beyond six months) for this permanent implant is unknown at present.
P830026|S074|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX 7000 PROGRAMMING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/09/1998|02/18/1999|||APPR|Approval for Rx7000 Programming System Model 522-17 with R1.00.00 Software.  The device, as modified, will be marketed under the trade name Rx7000 Model 522-17 Porgrammer and is indicated for the interrogation and programming of Sulzer Intermedics pulse generators.
P870056|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/1998|10/26/1998|||OK30|The 30-day Notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprotheses.
P870077|S008|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS MODELS 6625LP AND 6625 LP-ESR|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/1998|10/26/1998|||OK30|The 30-day notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprostheses.
P860057|S009|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE MODELS 2700 AND 2800|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/1998|10/26/1998|||OK30|The 30-day Notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprostheses.
P830060|S043|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BIPOLAR ENDOCARDIAL LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/13/1998|11/04/1998|||APPR|Approval for changes to the IS-1 terminal pin for Lead Models 0013 and 0015, and minor labeling changes.
P950009|S003|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|AUTOPAP SYSTEM|MNM|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/13/1998|01/19/1999|||APPR|Approval for removal of the stage three-alarm unit.  The device is to be used only on conventionally prepared Pap smear slides and is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as "high risk."  Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.
P960018|S001|HEALTHCARE PRODUCTS PLUS, INC.|2119 NORTH KENMORE AVE.||CHICAGO|IL|60614||Device, needle destruction|THE NEEDLE DESTROYER|MTV|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/14/1998|11/17/1998|||APPR|Approval for a change to the battery charger and the associated instructions for use.
P790020|S059|ADVANCED MEDICAL OPTICS, INC.|1700 EAST ST. ANDREW PL.||SANTA ANA|CA|92705||Lenses, soft contact, extended wear|PERMAFLEX NATURALS|LPM|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/1998|10/27/1998|||APPR|Approval for a ten year expiration date for the Permaflex Naturals (Surfilcon A) Hydrophilic contact lenses.
P940015|S002|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC (HYLAN G-F 20)|MOZ|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/1998|02/19/1999|||APPR|Approval for a manufacturing site located at Biomatrix, Inc., 1125 Pleasantview Terrace, Radgefield, NJ.
P940034|S009|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121|||AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST||MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/19/1998|12/01/1998|||APPR|Approval for additional text under Warnings:  "Sediments prepared using Alpha-Tec Systems, Inc. NAC-PAC(TM) XPR-plus(TM) A.F.B. Processing Buffer have been shown to interfere with amplification."
P970020|S006|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/1998|11/10/1998|||OK30|The 30-day Notice requested that FDA review a change in the manufacturing process, removing the C-flex Junction Shear Strength Test, a design verification test, from production testing of the ACS RX MULTI-LINK(TM) Coronary Stent System and the ACS RX MULTI-LINK HP(TM) Coronary Stent System.
P960043|S012|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR/PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/1998|02/19/1999|||APPR|Approval for a manufacturing site located at Perclose, Inc., 400 Saginaw Dr., Redwood City, CA.
P950019|S005|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY TFC DEVICE INSTRUMENTATION|MAX|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/1998|10/29/1998|||APPR|Approval for modified instrument inserts.
P970035|S009|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/1998|11/17/1998|||OK30|The 30-day Notice requested a change int he current Thermal Transfer Printing on the Strain Relief to Ink Jet Printing on the Proximal Two-arm Luer Adapter.
P970035|S010|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|GFX OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/1998|11/17/1998|||OK30|The 30-day Notice requested a change in the current Secure Strain Relief Process et temperature from 300 degrees F to 260 degrees F in order to optimize the process.
P970008|S009|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|RECTAL THERMOSENSING UNIT RTU|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/1998|10/29/1998|||APPR|Approval for minor changes in the design and labeling of the Rectal Thermosensing Unit.
P970004|S004|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/1998|04/15/1999|99M-1306|07/12/1999|APPR|Approval for the Medtronic(R) Interstim(R) System for Urinary Control.  This device is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequency in patients who have failed or could not tolerate more conservative treatments.
P970034|S001|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|UV ABSORBING-PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/1998|11/20/1998|||OK30|The 30-day Notice requested approval to introduce a manufacturing process change for the device.  The nature of the change is to use an alternate sterilization chambera t Griffith MicroScience, the same sterilization contractor approved in the firm's original PMA.  Griffith is upgrading the chamber that was previously used.  Some of the parameters of the sterilization process are being changed.  The changes include reduction of the minimum preconditioning time, specification of the transfer time to move the load from the preconditioning room into the sterilization chamber, use of a larger sterilization chamber, use of a computer-controlled process versus a manually-controlled process and the addition of post-ethylene oxide exposure vacuum dwell times.
P850064|S015|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/1998|04/05/1999|||APPR|Approval for extending the duration of use for the breathing circuit.
P790018|S034|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/1998|11/16/1998|||OK30|The 30-day notice requested a change in the supplier of a raw material (yarn) for the device because the current supplier of Polytetrafluoroethylene (PTFE) yarn has chosen to withdraw this material from the implantable medical device industry.
P960058|S008|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)||EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/27/1998|01/19/1999|||APPR|Approval for expansion of the indication for use of the Advanced Bionics CLARION Multi-Strategy Cochlear Implant to include children 18 months and older.
P950032|S004|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|10/28/1998|01/06/1999|||APPR|Response to conditions of approval cited in May 22, 1998, Approval Order: 1) Revisions in karyology, growth rate and morphology testing and 2) Protocol 98-VSU-002, "A Prospective Study to Determine the Longevity of Apligraf Cells on Patients with Venous Ulcers" as well as the cited methods for obtaining documentation of the viral inactivation processes for transferrin.
P780010|S020|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMLENS|LPM|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/28/1998|12/04/1998|||APPR|Approval for a ten (10) year expiration date for the Permalens (perfilcon A) Hydrophilic contact lenses.  The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications.
P910061|S005|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1998|12/28/1998|||APPR|Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P870045|S040|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1998|12/28/1998|||APPR|Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P790027|S061|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1998|12/28/1998|||APPR|Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P870013|S010|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1998|12/28/1998|||APPR|Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P850059|S018|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/1998|12/28/1998|||APPR|Approval for use of an alternate sterilization chamber at Griffith MicroScience.
P980009|S001|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT ENDOPROTHESIS NATIVE CORONARY INDICATION|MAF|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|10/30/1998|01/27/1999|||APPR|Approval for protocol for the post approval study.
P980016|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MODEL 7271 ICD||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/1998|01/06/1999|||APPR|Approval for a manufacturing site located at Medtronic, Inc., Med Rel, Road 909, KM 0.4, Barrio Mariana, Humacao, Puerto Rico, 00661.
P940016|S001|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1998|04/26/1999|N||APPR|Approval for a change in the potting resin material (i.e., from polypropylene Valtech (Montell) HH-44 to polypropylene Pro-Fax PH920S) used to seal the end caps of the H.E.L.P. System Precipitate Filter.
P910018|S001|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1998|10/29/1999|||APPR|Approval for the following changes:  1) replacing the Membrane Filter Unit (MFU) located in the Liposorber LA-15 adsorption column, with the Cardioplegia Supor-1220 filter, which is bonded to the Extracoporeal Blood Tubing System, LT-MA2; 2) removing the maintenance unit and adding a clamp valve cover plate to the MA-01 Apheresis Unit; 3) making nine software changes, most of which are intended to either simplify procedures, ease the display of treatment parameters, or to make the therapy safer for the patients; and, 4) revising the Operators' Manual to incorporate the revisions associated with the hardware and software changes.
P960057|S002|WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON -L ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/1998|11/25/1998|N||APPR|Approval for a change in ADCON-L kit packaging configuration, i.e., replacing the aluminum tube with a polypropylene syringe, and replacing the PVC application with a polypropylene applicator.
P810002|S048|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MASTERS SERIES MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/1998|04/16/1999|||APPR|Approval for the addition of 35mm and 37mm mitral valve sizes to the SJM(R) Master Series Mechanical Heart Valve product line (SJM(TM) Master Series with Polyester Cuff, model number MJ-501, and SJM(R) Master Series with Silzone(TM) coating, Polyester Cuff, model number MS-601).
P890040|S005|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/1998|03/23/2000|||APPR|Approval for a manufacturing site located at Unilens Corporation, Largo, Florida.
P830060|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SWEET TIP|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/1998|12/08/1998|||APPR|Approval for use of a larger diameter wire helix in the lead's tip electrode, and associated labeling changes.
P860004|S041|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED PUMP HYBRID|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|11/09/1998|12/04/1998|||APPR|Approval for modifications to the device: 1) Replacement of the quartz crystal oscillator with a surface mount crystal oscillator with the same electrical operating specifications, 2) Replacement of the ceramic wiring board with a fiberglass printed wiring board, 3)Mounting the antenna/reedswitch assembly directly on the wiring board 4) Replacement of the ceramic chip carrier packaging of the microprocessor and integrated circuit with plastic packages, 5) Attachment of the hybrid printed wiring board to the pump center plate with two sided, acrylic adhesive tape rather than a bracket and plastic cup assembly.
P970024|S001|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable cardioverter defibrillator (non-CRT)|LYRA IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR:ANGEPASS DEFIBRILLATION LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/10/1998|03/05/1999|||APPR|Approval for the Lyra(TM) ICD System (Models 2020, 2021, and 2022), Model 6200 Programmer Software, Smart Wand Programming Head Model 3009, Angepass(TM) RV Defibrillation Lead System (Model 4040, 4041, and 4042), and AngePass(TM) SVC Defibrillation Lead System (Models 4080, 4081, and 4082). The devices as modified will be marketed under the trade names Lyra(TM) and AngePass(TM), and are indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) Survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; and 2)Recurrent, poorly tolerated, sustained ventricular tachyarrhythmia.
P830056|S079|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||intraocular lens|MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1998|05/11/1999|||APPR|Approval for posterior chamber intraocular lens models C451F, C421F, and C455A5.  These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed using extracapsular extraction methods.  The lenses are intended to be placed in either the ciliary sulcus or capsular bag.
P970017|S001|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Bone sonometer|HOLOGIC SAHARA CLINICAL BONE SONOMETER|MUA|RA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1998|04/29/1999|||APPR|Approval for a change in the manufacturing site to 35 Crosby Dr., Bedford, MA 01730.
P970035|S011|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1998|06/03/1999|||APPR|Approval for the Medtronic AVE S540(TM) Over-The_Wire Coronary Stent System.  The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (length <24 mm) within a native coronary artery or arterial bypass graft conduit with a reference diameter between 2.2 and 2.9mm.  Long term outcome (beyond 30 days) for this permanent implant is unknown at present.
P960043|S013|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR AND PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/1998|12/07/1998|||APPR|Approval for an alternate sterilization facility located at Griffith Micro Science, Inc. 4900 South Gifford Ave., Los Angeles, CA 90058.
P970019|S005|HEALTH TRONICS SURGICAL SERVICES, INC.|425 FRANKLIN RD., SUITE 545||MARIETTA|GA|30067||Lithotriptor, extracorporeal shock-wave,urological|LITHO TRON LITHOTRIPSY SYSTEM|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/1998|11/17/1998|||APRL|Approval for use of a new patient table model with the LithoTron(TM) Lithotripsy System, with associated labeling changes.
P920034|S003|MEDIREX, INC.|49 WALNUT PARK||WELLESLEY HILLS|MA|02181||Lithotriptor, extracorporeal shock-wave,urological|TRIPTER-X1|LNS|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|11/12/1998|12/14/1998|||APRL|1)Contained the final report of postapproval study regarding the possible relationship between extracorporeal shock wave lithotripsy and the onset of hypertension, and 2) requested approval for modifications to the Tripter-X1's labeling to reflect the results of this final report.
P960043|S014|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||PROSTAR XL AND TECHSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/16/1998|12/21/1998|||APPR|Approval for adding precautions to the Clinical Procedure section of the Instructions for Use regarding suture lumen clamping.
P960006|S002|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET TIP RX MODELS 4143/4144/4145/4243/4244/4245 ACTIVE-FIXATION, STEROID ELUTING, ENDOCARDIAL PACING LEADS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/29/1998|11/17/1998|||APPR|Approval for a change in the IS-1 terminal connector.
P870072|S009|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/1998|03/19/1999|||APPR|Approval to move manufacturing facility located at Thoratec Lab, 2023 Eighth St., Berkeley, CA, to Thoratec Lab, 6035 Stoneridge Dr., Pleasanton, CA.
P970003|S012|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/1998|12/18/1998|||APPR|Approval for the Model 250 NCP Programming Software Version 4.3 (for use with Model 100 NCP Pulse Generator Versions B and C).
P900039|S010|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT STRIP BONE GRAFT MATRIX|MBS|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/1998|12/07/1998|||APPR|Approval for changes to your manufacturing process.  These changes involve 1) moving some of the manufacturing operations currently performed in a Class 100 room to a "controlled" environment that provides the equivalent of a Class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the LAL pyrogenicity assay, as described in the supplement.
P970061|S006|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM/31MM RADIUS OTW & 31 MM RADIUS SOE||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/1998|06/30/1999|||APPR|Approval for the 31 mm SCIMED(R) RADIUS(TM) Coronary Stent with Over-The-Wire (OTW) and Single-Operator (SOE) Delivery Systems.
P960040|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV AICD FAMILY SYSTEMS||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/1998|12/08/1998|||APPR|Approval for revisions to the Physician's Manuals of the Ventak(R) AV(TM) AICD(TM) Systems.
P950032|S007|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/1998|02/01/1999|||APPR|Approval for responses to condition of approval cited in FDA's 5/22/98 Approval Order, i.e., concerning the purity of the transferrin used in device manufacture.
P900043|S013|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/1998|04/15/1999|||APPR|Approval for the PALMAZ-SCHATZ(TM) MiniCrown Balloon Expandable Stent with Dynasty(TM) Over the Wire Delivery System (11 mm and 15 mm stent lengths with 2.25, 2.50, 2.75, 3.00, and 3.25 mm balloon diameters).  The device is indicated for improving coronary luminal diameter in the following:  Treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions (< 25mm) with a reference vessel diameters in the range of 2.25 to 3.25mm.  Long term outcome (beyond 1 month) for this permanent implant is unknown at present.
P910061|S006|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|BAUSCH & LOMB SURGICAL SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER LENS|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/1998|12/14/1998|||APPR|Approval for the addition of a tumbling and an alternative extraction process to the manufacture of silicone lenses.
P910023|S037|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/23/1998|12/09/1998|||APPR|Approval to use alternate silicone materials in the manufacture of Ventritex implantable defibrillators.
P950022|S004|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|TVL LEAD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/23/1998|12/09/1998|||APPR|Approval to use alternate silicone materials in the manufacture of Ventritex defibrillator leads.
P960040|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV II/III DR AICD SYSTEMS||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/03/1998|12/08/1998|N||APPR|Approval for Software Application Model 2843 Version 2.7 for use with VENTAK(R) AV II/III(TM) Systems.
P950035|S003|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM|GZC|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/1998|01/19/1999|||APPR|Approval for a new manufacturing site located at NeuroControl Corporation, 8333 Rockside Road, Valley View, OH.
P810046|S194|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX SOLARIS CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/1998|04/14/1999|||APPR|Approval for additional balloon sizes and an additional indication for use for the ACS RX Solaris(TM) Coronary Dilatation Catheter.  The device as indicated for: a)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.  b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. c) Balloon dilatation of the ACS MULTI-LINK DUET(TM) stent after implantation.  This indication applies to the following balloon sizes and stent lengths:  Ballon Size:3.0-4.0mmx9mm    Stent Length: 13mm            3.0-4.0mmx15mm                 18mm            3.0-4.0mmx20mm                 23mm            3.0-4.0mmx25mm                 28mm
P950032|S008|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|12/04/1998|02/23/1999|||APPR|Approval for a protocol for evaluating the karyology of keratinocyte and fibroblast cell strains used in Apligraf manufacture.
P970015|S003|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||INTER FIX THREADED FUSION DEVICE||OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/04/1998|05/14/1999|||APPR|
P970003|S013|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/04/1998|12/18/1998|||APPR|Approval for the Model 500 NCP Accessory Pack.
P980016|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC MODEL 7273 GEM II DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9964 (GEM II DR) AP||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/1998|01/28/1999|||APPR|Approval for the Medtronic(R) GEM(TM) II DR Model 7273 Implantable Cardioverter Defibrillator with Medtronic(R) Model 9964 GEM(TM) II DR Programmer Application Software.
P960042|S003|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159||14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/14/1998|02/08/1999|||APPR|Approval for separately packaged 12 French Outer Sheaths.
P830039|S009|MEDICALCV, INC.|9725 SOUTH ROBERT TRAIL||INVER GROVE HEIGHTS|MN|55077||HEART-VALVE, MECHANICAL|OMNISCIENCE CARDIAC VALVE PROSTHESIS|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/1998|12/30/1998|||OK30|1. MIXTURE OF STERILANT GAS FOR THE ETHYLENE OXIDE GAS NOW USED 2. A CHANGE IN THE VEHICLE FOR THE BACILLUS SUBTILIS VAR. NIGER BIOLOGICAL INDICATOR SAMPLES USED FOR STERILITY 3. REDUCTION OF THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS
P980015|S001|INNOVATIVE MEDICAL SYSTEMS, INC.|3610 OAKDALE DRIVE||MOUNTAIN BROOK|AL|35223||Device, needle destruction|SHARP NEEDLE DESTRUCTION UNIT|MTV|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/1998|12/14/1998|||APPR|Approval for the modifications of device and to the labeling.  The modifications to the device were noted to include the addition of a charger base and modifications to the device housing, electrode assembly and filter.
P970020|S007|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX DUET CORONARY STENT SYSTEM AND THE ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/1998|01/12/1999|||APPR|Approval for an alternate sterilization site located at Advanced Cardiovascular Systems, 26531 Ynez Road, Temecular, CA 92591-4628.
P950037|S006|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|ACTROS+|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/1998|01/05/1999|||APPR|Approval for a name change of the approved ACTROS Pulse Generator family to the ACTROS+ Pulse Generator family.  The device, which has not been modified, will be marketed under the trade name ACTROS+ and is indicated for patients exhibiting chronotropic incompetence and who would benefit from increase pacing rates concurrent with physical activity.  Generally accepted indications for long-term cardiac pacing inlcude, but are not limited to:sick sinus syndrom (i.e., bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial(SA) block, second- and third- degree AV block and carotid sinus syndrome.  Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual-chamber or atrial pacing modes.  Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both resoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.
P790017|S068|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|OVER THE WIRE DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/1998|01/08/1999|||OK30|The 30-Day Notice requested to modify the sterilization parameters to address the excessively long Ethylene Oxide residue quarantine times by reducing as exposure minor modifications to the sterilization parameters are also being introduced to improve efficiency and increase flexibility at the contract sterilization facility.
P970035|S012|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/1998|12/29/1998|||OK30|The 30-Day Notice requested to add an additional step in the manufacturing of multilumen tubing.  The additional step would consist of compounding the virgin resin HDPE/Black-Colorant blend prior to the extrusion of multilumen tubing by AVE.  The compounding will be done by a vendor via machine mixing, extruded and then re-pelletized to provide compounded resin pellets of the blend required for extrusion of AVE's multilumen tubing.
P860019|S151|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/14/1998|01/11/1999|||APPR|Approval for the reduction in the rated burst pressure from 16 to 14 atm for all available lengths (20, 30, and 40mm) of the 2.0mm and 2.5mm diameter balloon sizes of the COYOTE(TM) PTCA catheter.
P930014|S006|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF SINGLE-PIECE FOLDABLE ACRYLIC POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/1998|09/20/1999|||APPR|Approval for the AcrySof(R) Single-Piece Foldable Acrylic Posterior Chamber IOL, Model SA30EL.
P940016|S004|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM|MMY|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|12/15/1998|08/12/1999|||APPR|Approval for administering the SF-36 quality of life (QOL) survey on an annual basis, instead of on a quarterly basis, of rthe patient registry/post approval study of the H.E.L.P. System.
P910018|S002|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|12/15/1998|04/09/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE PATIENT REGISTRY/POST-MARKET STUDY OF THE LIPOSORBER. LA-15 SYSTEM.
P960043|S015|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/1998|06/11/1999|||APPR|Approval for a modified needle holder.
P970058|S003|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER|MYN|RA|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|12/16/1998|02/10/1999|||APPR|Approval for proposed post approval study protocol for the ImageChecker M1000.
P810046|S195|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS OTW SOLARIS CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1998|05/19/1999|||APPR|Approval for a new catheter model.
P910077|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6960 SWITCHABLE ECG PATIENT CABLE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/1998|01/20/1999|||APPR|Approva for a switchable ECG cable that allows the clinician to display and record ECG signals from seven different vectors (leads) without moving the ECG electrodes that are attached to the patient.  The device, as modified, will be marketed under the trade name Model 6960 Switchable ECG Cable and is indicated for use as an accessory to the Models 2950 and 2901 Programmer/Recorder/Monitors (PRMs).
N17600|S016|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)|LMF|SU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/1998|02/28/2000|||APPR|Approval to market a product line extension.
N16374|S036|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE|PRONOVA ABSORABLE SUTURE, USP|GAT|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1998|06/24/1999|||APPR|Approval for the PRONOVA Non-absorbable Suture manufactured from poly (vinylidene fluoride) and poly (vinylidene fluoride-co-hexafluoropropylene).  The device, as modified, will be marketed under the trade name PRONOVA and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
P970003|S014|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/21/1998|01/20/1999|||APPR|Approval for labeling changes being made to the Model 100 NCP PUlse Generator Physician's Manual, the Model 300 NCP Bipolar Lead Physician's Manual, and the Patient's Manual for the NCP System.
P960057|S003|WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON -L ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/1998|01/14/1999|||OK30|The 30-Day Notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the Adcon(R)-L Adhesion Control Barrier Gel.  The proposed modifications are designed to increase the efficiency of the gel manufacturing process.
P970034|S002|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|UV-PMMA PCLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/1998|01/12/1999|||APPR|Approval for a packaging facility located at 1501 W. 9th Street, Suite D, Upland, CA 91785.
P790002|S020|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/22/1998|01/26/1999|||APPR|Approval for the EBI Bone Healing System - Model 2001, indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudoarthroses in the appendicular system.
P810046|S196|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)|LOX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/1998|01/22/1999|||APPR|Approval for the implementation of an additional quality control inspection to further ensure that hte balloon size designation on the proximal adaptor is correct fo rthe ACS RX Comet VP(TM) Coronary Dilatation Catheter and the other ACS Coronary Dilatation Catheters listed in the supplement.
P880047|S007|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED*(TC7) ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/1998|05/24/1999|||APPR|Approval for revised labeling to reflect a recent study finding that laproscopic use increased adhesions compared to the control group.
P910061|S007|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX UV ABSORBING SILICONE POSTERIOR INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/1998|03/08/1999|||APPR|Approval for a manufacturing qualification protocol and a manufacturing site located at 21 Park Place Blvd., N., Clearwater, FL  33759.
P950021|S001|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|BAYER IMMUNO 1 SYSTEM|LTJ|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/1998|06/25/1999|99M-2748||APPR|Approval for the Bayer Immuno 1(TM) PSA assay.  This device is indicated for the measurement of serum PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older.  This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.
P890043|S033|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/23/1998|09/30/1999|||APPR|Approval for a change in the labeling for the Simpson Coronary AtheroCath(R) SCA-EX(TM), GTO(R), and BANTAM(TM) Atherectomy Catheters to 1) include clinical data from the Balloon versus Optimal Atherectomy Trial (BOAT) and 2) streamline the remainder of the text.
P950027|S004|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/23/1998|08/30/2000|||APPR|APPROVAL TO MODIFY LABELING, ADDING INFORMATION ABOUT THE CURRENT CLINICAL EXPERIENCE OF THE DEVICE.
P950034|S010|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/1998|01/13/1999|||OK30|The 30-Day Notice requested a manufacturing process change for Seprafilm(R) Bioresorbable Membrane.  The requested change would allow processed ethanol to be reused during the precipitation step of the sodium hyaluronate/carboxymethylecellulose (HA/CMC) powder manufacturing process.
P970020|S008|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX AND OTW DUET CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/1998|01/25/1999|||OK30|The 30-day Notice requested the addition of an on-line inspection to the manufacturing process to provide additional assurance of stent security on the delivery system.
P970020|S009|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK STENTS|MAF|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/1998|01/28/1999|||APPR|Approval for implementation of an additional quality control inpsection to further ensure that the balloon size designation on the proximal adaptor is correct for the ACS Multi-Link and ACS Multi-Link Duet Coronary Stent Systems listed in the supplement.
P970003|S015|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/1998|01/28/1999|||APPR|Approval for a new manufacturing site located at Cyberonics, Inc., 16511 Space Center Blvd., Suite 500, Houston, TX.
P980009|S002|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|12/28/1998|07/28/1999|||APPR|Approval to add an indication for the treatment of saphenous vein grafts.  The device is now indicated for improving luminal diameter in the following:  1)pts w/symptomatic ischemic disease due to discrete de novo lesion in native coronary arteries (length < 35 mm) wiht a reference vessel diameter of 3.0 to 5.5 mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 3.0 to 5.5 mm.  3) Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesions length < 35mm and reference vessel diameter in the range of 3.0 to 5.5mm.
P850059|S019|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|ANTERIOR CHAMBER IOL'S|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1998|01/28/1999|||APPR|Approval for an alternate packaging configuration for the PMMA IOLs, manufactured at Claremont, CA facility.
P870013|S011|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|ANTERIOR CHAMBER IOL'S|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1998|01/28/1999|||APPR|Approval for an alternate packaging configuration for the PMMA IOLs, manufactured at Claremont, CA facility.
P790027|S062|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER IOL'S|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1998|01/28/1999|||APPR|Approval for an alternate packaging configuration for the PMMA IOLs, manufactured at Claremont, CA facility.
P980017|S001|POSSIS MEDICAL, INC.|9055 EVERGREEN BLVD., N.W.||MINNEAPOLIS|MN|55433|8003||POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/29/1998|03/24/1999|||APPR|Approval for extending the shelf life of the device from 3 to 6 years, and is indicated for use as a subcutaneous arteriovenous shunt graft to provide immediate and subsequent chronic blood access for high-efficiency hemodialysis in patients who meet one or more of the following conditions:  1)central venous cannulation is deemed hazardous or is technically unabailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.
P960009|S004|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MRDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/29/1998|03/25/1999|||APPR|Approval for corrections to an educational brochure which contains instructions for routing and implantation of the lead to extension connection and the addition of a new warning label.
P890017|S006|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLON-EXPANABLE STENT|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/1998|02/05/1999|||APPR|Approval for a manufacturing site located at Cordis Corporation, 14201 N.W. 60th Ave., Miami Lakes, FL 33014.
P870049|S028|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/04/1999|01/25/1999|||APPR|Approval for the addition of a limitation to use an alternative method for testing of Proteus mirabilis and Enterobacter spp. with the antibiotic Cefazolin in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.
P970003|S016|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/04/1999|02/18/1999|||APPR|Approval for the Model 201 NCP Programming Wand (for use with Model 100 NCP Pulse Generator Versions B and C).
P970003|S017|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/04/1999|01/28/1999|||OK30|The 30-Day Notice requested to bring in-house a seam welding process equivalent to processes performed by subcontractors.  The welding process involves welding the can bottom half of the Pulse Generator to a can lid.
P880081|S024|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/1999|07/02/1999|||APPR|Approval for modifications to the labeling for SLM-2/UV intraocular lenses (IOLs) to incorporate recent findings regarding the comparative incidence of posterior capsule opacification and Nd:YAG capsulotomy with silicone IOLs approved under this PMA versus polymethylmethacrylate (PMMA) IOLs.
P960043|S016|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/08/1999|05/28/1999|||APPR|Approval for modifications to the instructions for use to include an alternative surgical knot.
P970051|S004|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/1999|06/09/1999|||APPR|Approval for Continuous Interleaved Sampling (CIS) and Advanced Combination Encoders (ACE) speech coding strategies.
P960040|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK VR OMDEL 1774/MODEL 1775 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH MODEL 2841 SOFTWARE APPLICATION||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/12/1999|05/03/1999|||APPR|Approval for the VENTAK(R) VR AICD(TM) System with Model 2841 Software, Version 1.4.
P840001|S043|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/1999|02/10/1999|||APPR|Approval for revisions to the existing Model 7495 Quadripolar Extension Kit used in conjunction with the Medtronic Itrel Spinal Cord Stimulation System.
P960009|S005|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/1999|02/10/1999|||APPR|Approval for revisions to the existing Model 7495 Quadripolar Extension Kit used in conjunction with the Medtronic Activa Tremor Control System.
P870018|S022|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|TRANSMOBILE LITHOSTAR MODULARIS|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/1999|01/21/1999|||APRL|Approval for a transportable (between hospitals) Lithostar Modularis.
P950014|S017|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON, MAXIS AND PRAKTIS|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/13/1999|01/25/1999|||APPR|Approval for minor changes to the design of the Prostaprobe.
P960040|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||VENTAK AV  AICD & VENTAK AV II DDD AICD||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/1999|01/20/1999|||APPR|Approval for Software Application Model 2833 Version 3.1 for use with VENTAK(R) AV I/II(TM) DDD AICD(TM) Systems.
P790017|S069|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|D114S OVER-THE-WIRE BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/1998|07/22/1999|||APPR|Approval for the D114S Over-the-Wire Balloon Dilatation Catheter.  The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P980001|S003|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEM||CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/1999|02/25/1999|||APPR|
P980009|S003|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/19/1999|02/17/1999|||APPR|Approval for change to the Instructions for Use.
P970003|S018|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/19/1999|02/18/1999|||APPR|Approval for the Model 250 NCP Programming Software Version 4.4 (for use with Model 100 NCP Pulse Generator Versions B and C).
P950019|S006|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY FUSION THREADED CAGE (TFC) DEVICE|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/20/1999|02/05/1999|||APPR|Approval for modified, lengthened instruments.
P950037|S007|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/20/1999|08/04/1999|||APPR|Approval for a VDDR single pass lead system.  The device is indicated for the following:  The Actros SLR+ and Kairos SL pacemakers are intended to provide VDD or VDDR pacing for patients with a healthy sinus node and AV conduction abnormalities. These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. this include the presence of complete A-v block when: 1) atrial contribution is needed for hemodynamic benefit; and 2) pacemaker syndrome had existed or is anticipated. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration or rate and AV synchrony such as AV nodal disease, diminished cardiac output, or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing. Additional indications include: normal sinus rhythm and normal A-V conduction in patients who intermittently need ventricular pacing support.
P880091|S016|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIMIDE UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/22/1999|08/31/1999|||APPR|Approval for lens Model AQ-5010V in the power range of -4.0 to +4.0 diopters in 1.0 diopter increments.
P860019|S152|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED SINGLE OPERATOR EXCHANGE PTCA CATHETERS|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/1999|02/26/1999|||APPR|Approval to incorporate the term "Monorail" in the labeling for Scimed single Operator Exchange (SOE) PTCA catheters.
P970043|S001|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/1999|09/24/1999|||APPR|Approval for the inclusion of labeling claims in the Patient Information Booklet, Physician's Booklet, and System Operation Manual regarding the effectiveness of the eye tracker component of the LADARVision(R) Excimer Laser System when used for the approved indication.  Other requested modifications to the labeling included updates to data tables in the Physician's Booklet, and editorial changes and revised operational procedures in the System Operation Manual.
P860019|S153|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/1999|05/11/1999|||APPR|Approval for a sterilization facility located at Griffith Micro Science Wallonie, Zoning Industrial De Petit-Rechain, 4800 Verviers, Belgium.
P970044|S003|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROWAVE|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/1999|03/12/1999|||APPR|Approval for a manufacturing site located at Dornier Medizintechnik GmbH, Argeisrieder Feld 7, D-82234 Wessling, Germany.
P840008|S067|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA|LNS|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/1999|03/12/1999|||APRL|Approval for a manufacturing site located at Dornier Medizintechnik GmbH, Argeisrieder Feld 7, D-82234 Wessling, Germany.
P970021|S002|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|THERMA CHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/03/1999|11/02/1999|||APPR|Approval for the following modifications:  1) change in balloon material from latex to silicone; 2) addition of fluid circulation mechanism (i.e., impeller) within catheter; 3) change in software language from Assembly to a combination of C and Assembly; and 4) other minor modifications to the device system.  In addition, changes also include a change in the manufacturer of the catheter controller to RELA, Inc., located at 410 S. Sunset, Bldg., D., Longmont, CO  80501.  The device is intended for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete.
P960058|S009|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/04/1999|03/22/1999|||APPR|Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.
P910023|S038|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/04/1999|02/12/1999|||APPR|Approval for minor labeling changes in the Profile MD User's Manual.
P940022|S010|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)|MCM|EN|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/1999|03/22/1999|||APPR|Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.
P890055|S008|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|FLEX TIP PLUS INTRASPINAL CATHETER KIT(CATHETER CONNECTOR)|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/1999|12/10/1999|||APPR|Approval for the following modifications of the existing Flex Tip Plus Intraspinal Catheter Kit catalog #AP-07008:  1) Addition of a "locking feature" to the current catheter connector design to prevent the connector from being inadvertently opened.  2) Addition of a "stylet" to the kit. 3) Replacement of the blunt flushing needle with the "Snap Lock Flushing Adapter". 4) Addition of the "threading guide" and the "attachable wing hub". 5) Increasing the Flex Tip Plus Intraspinal Catheter length.
P980016|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/1999|07/27/1999|||APPR|Approval for the Model 7229 (GEM(TM) II VR) Implantable Cardioverter Defibrillator and Model 9964 Application Software and the quality assurance test method and specification for screening the GEM(TM) II VR for premature battery depletion, and the revised L222 integrated circuit.
P940010|S006|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE CYLINDRICAL FIBER OPTIC(DCYL2 DIFFUSER SERIES)|MVG|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/1999|03/04/1999|||APPR|Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
P910023|S039|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/1999|03/01/1999|||APPR|Approval to provide the standard Medic Alert(R) information with the Ventritex implantable cardiovertor defibrillators.
P980016|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC MODEL 6940 STERIOC ELUTING BIPOLAR IMPALNTABLE SCREW-IN VENTRICULAR/ATRIAL TRANSVENOUS LEAD||CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/1999|03/05/1999|||APPR|Approval for use of the Model 6940 CapSureFix Ventricular/Atrial Transvenous Lead.  The device, as modified will be marketed under the trade name Model 6940 CapSureFix Lead and is intended for single long-term use in the right ventricle or right atrium for pacing and sensing.
P900043|S014|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ CROWN STENT WITH POWERGRIP OTW DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/1999|03/31/1999|||APPR|Approval for an extension in shelf life from 1 year to 18 months.
P970024|S002|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable cardioverter defibrillator (non-CRT)|MULTI-PARTITION OPERATING ENVIRONMENT (MOE), VERSION 1.0|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/1999|02/23/1999|||APPR|Approval for Multi-partition Operating Environment version 1.0.
P880072|S047|EYEKON MEDICAL, INC.|2451 ENTERPRISE RD.||CLEARWATER|FL|33763||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/1999|06/20/2000|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT MEDICAL DEVELOPMENTAL RESEARCH, INC., CLEARWATER, FLORIDA 33763.
P950022|S005|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|TVL LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/1999|03/26/1999|||APPR|Approval for a manufacturing site located at the St. Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577.
P910023|S040|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/1999|03/26/1999|||APPR|Approval for a manufacturing site located at the St. Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577.
P980001|S004|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR ON RANGER AND NIR ON RANGER WITH/SOX||CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1999|03/10/1999|||APPR|Approval for a change in the specification of the balloon component for the NIR ON(TM) Ranger(TM) Premounted Stent System.  This change applies only to the 9 mm length NIR ON(TM) Ranger(TM) Premounted Stent System with the 3.0mm, 3.5mm and 4.0mm balloon diameters.
P810002|S049|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MASTERS SERIES COATED AORTIC VALVED GRAFT(MODEL CAVGJ-514)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/1999|07/28/1999|||APPR|Approval for the SJM(R) Master Series Aortic Valved Graft with Meadox(R) Hemashield(R) Woven Double Velour Graft, Model CAVGJ-514, in sizes 19, 21, 23, 25, 27, 29, 31, and 33 mm.  This device is indicated for use when the aortic valve and the ascending aorta must be replaced.
P810046|S197|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX GEMINI CORONARY DILATATION CATHETER|LOX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/1999|03/04/1999|||APPR|Approval for the implementation of an additional quality control inspection to further ensure that the balloon size designation on the proximal adaptor is correct for the ACS RX Gemini(TM) Coronary Dilatation Catheter.
P970010|S001|SYNTHES (USA)|1690 RUSSELL RD.|POST OFFICE BOX 1766|PAOLI|PA|19301||BONE CEMENT|NORIAN SRS CEMENT|LOD|PM|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|02/08/1999|07/16/1999|||APPR|Approval for the post-approval clinical and animal study protocols that were requested as Conditions of Approval for the PMA.
P790027|S063|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV ABSORBING PMMA ANTERIOR AND POSTERIOR CHAMBER IOLS|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1999|03/15/1999|||APPR|Approval for minor revision to the labeling and an alternate sterilization method.
P850059|S020|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|UV ABSORBING PMMA ANTERIOR AND POSTERIOR CHAMBER IOLS|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1999|03/15/1999|||APPR|Approval for minor revision to the labeling and an alternate sterilization method.
P870013|S012|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV ABSORBING PMMA ANTERIOR AND POSTERIOR CHAMBER IOLS|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1999|03/15/1999|||APPR|Approval for minor revision to the labeling and an alternate sterilization  method.
P910061|S008|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX UV ABSORBING SILICONE POSTERIOR CHAMBER IOLS|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/1999|03/15/1999|||APPR|Approval for minor revision to the labeling and an alternate sterilization method.
P930034|S013|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|SVS APEX PLUS EXCIMER LASER WORKSTATION|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|02/11/1999|10/21/1999|00M-1591|11/03/2000|APPR|APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS(R) "M" DISCS (M00-M09)  THESE DEVICES ARE INDICATED TO PERFORM LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM 0.0 TO -14.0 DIOPTERS (D) WITH OR WITHOUT ASTIGMATISM RANGING FROM -0.5D TO -5.0D; 2) IN PATIENTS 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION (+0.5D) OVER THE PAST YEAR.
P950018|S002|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLURON|LWL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/1999|03/05/1999|||APPR|Approval for the following changes:  use of an alternate Fluorotec S2-F451W stopper; changes in the aseptic filling and packaging processes to use the CBL Autobloc automated filling line; an alternate fill volume (2 ml) for Perfluoron in a unit package; a new Master Batch Record for the automated filling line which includes 2 ml, 5 ml and 7 ml fill volumes and a lot size increase to a maximum of 9,000 vials per lot; secondary packaging configurations designed to provide a vial (5ml or 7ml) in a unit package without other kit components as well as in as accessory kit; and the kit components provided as a stand-alone accessory kit.
P950034|S011|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/1999|03/11/1999|||APPR|Approval for the extension of the expiration dating of Seprafilm(TM) Bioresorbable Membrane from 30 months to 36 months.
P900052|S007|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH EPIDURAL/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM|LNY|HO|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|02/11/1999|04/21/1999|||APPR|Approval for a change in the postapproval protocol to allow the use of Low Profile system which was approved on 10/28/98.
P950002|S007|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/1999|05/01/2002|||APPR|APPROVAL TO ADD THE BP/LORDOTIC TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BP/LORDOTIC AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L4-L5 AND/OR L5-S1 LEVELS.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S).  BP/LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR LAPAROSCOPIC APPROACH.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.  THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.
P870018|S023|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR MULTILINE|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/1999|04/30/1999|||APRL|Approval for a manufacturing site located at Siemens AG, Roentgenstrasse 19-21, Kemnath, Germany.  Final assembly and system testing of the Lithostar Multiline will be performed at this facility.
P960057|S004|WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON-L ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/1999|08/11/1999|||APPR|Approval for a patient brochure.  The device is indicated for use during single level, posterior lumbar laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
P970053|S001|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/16/1999|09/29/1999|00M-1664|12/13/2000|APPR|Approval for the Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism.  This device is intended for use in:  1) the reduction or elimination of myopia with astigmatism raning in severity from -1.00 to -8.00 diopters (D), in terms of manifest refraction spherical equivalent (MRSE), with refractive astigmatism ranging in severity from -0.5 to -4.00 D cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion.  A nomogram lookup table is provided for specific treatment combinations.  2) patients who have a stable history of both pretreatment myopic astigmatism (i.e., magnitude of change in manifest refraction of <0.5D per year in terms of MRSE for at least one year proceeding treatment) and pretreatment astigmatism (i.e., a magnitude of change of <0.5D per year in cylinder for at least one year preceding treatment); and 3) patients who are over 21 years of age.
P970008|S010|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/16/1999|02/19/1999|||APPR|Approval for an alternate supplier (Nortech Fiberonic) for the Targis(TM) Systems's fiber optic temperature sensor system.
P970008|S011|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/16/1999|05/03/1999|||APPR|Approval for modifications to the software to 1) add the cruise control option to the Targis(TM) System treatment and 2) make minor changes to the operation ofd the coolant system.
P970040|S001|GE LUNAR CORP.|726 HEARTLAND TRAIL||MADISON|WI|53717||Bone sonometer|ACHILLES EXPRESS ULTRASONOMETER|MUA|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/16/1999|04/23/1999|||APPR|Approval for a design change that was primarily to replace the open water bath with water enclosed in silicone membranes.  The device, as modified, will be marketed under the trade name Achilles Express and is indicated for:  The Achilles Express ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.  The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by x-ray absorptiometry at the spine or hip.
P910077|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/1999|03/17/1999|||APPR|Approval for a design and manufacturing change to the pulse generator hybrid assembly for the VENTAK(R) MINI III(TM) and MINI IV(TM) AICD(TM) Systems (Models 1782, 1783, 1786, 1788, 1789, 1790, 1792, 1793, and 1796).
P960042|S004|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159||SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FR||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/17/1999|08/03/1999|||APPR|Approval for a 2-year shelf life for the 14 Fr and 16 Fr Laser Sheath Kits.
P790027|S064|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOLAB BRAND UVBLOC PLUS(LC) UV-ABSORBING PMMA PC IOL'S|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1999|05/13/1999|||APPR|Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., 21 Park Place Blvd., North, Clearwater, FL 33759.
P870013|S013|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1999|05/13/1999|||APPR|Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., 21 Park Place Blvd., North, Clearwater, FL 33759.
P850059|S021|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|IOLAB BRAND MODEL 2192 KELMAN UVBLOC PLUS (LC) UV-ABSORBING PMMA AC IOLS|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/1999|05/13/1999|||APPR|Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., 21 Park Place Blvd., North, Clearwater, FL 33759.
P950019|S007|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION|MAX|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/1999|03/19/1999|||APPR|Approval for modified device outer box labels.
P960057|S005|WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON-L ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/1999|03/18/1999|||OK30|Accepted for an eight-day holding period for filled syringes prior to sterilization.
P910066|S013|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC 1000 BONE GROWTH STIMULATOR/PATIENT REGISTRY MARKETING BROCHURE|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/1999|04/20/1999|||APPR|Approval for updating the Patient Registry Data Sheet.
P950005|S004|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE|DRF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/1999|04/05/1999|||APPR|Approval for the 7 Fr and 8 Fr catheters incorporating a 5mm tip electrode.  The device, as modified, will be marketed under the trade name Celsius(TM) Diagnostic/Ablation Deflectable Braided Tip Catheter (5mm Tip Electrode) and is indicated for interruption of accessory AV conduction pathways assocated with tachycardia, the treatment of AV nodal reentrant tachycardia (AVNRT), and creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.  In addition to these indications, the 7 Fr catheter is also indicated for persistent junctional reciprocating tachycardia, Mahaim fibers, and pediatric patients (age 4 years or older).
P980023|S001|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|PHYLAX ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/1999|04/19/1999|||APPR|Approval for modifications to the programmer software used with Biotronik's MycroPhylax and Phylax XM ICD's.
P890055|S009|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CONSTANT FLOW IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/1999|01/21/2000|||APPR|Approval for adding the Drug Lioresal (Baclofen) to the list of drugs approved for use with the Model 3000-16 and Model 3000-50 Implantable Drug Delivery Pumps.  Also, the label will clearly indicate that baclofen is stable for 44 days at 37C.
N17679|S034|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|TETRAFILCON A|LPM|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/1999|03/17/1999|||APPR|Approval for an alternate tinting process, In-Monomer-Tinting Process.
P840008|S068|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/24/1999|02/26/1999|||APRL|Approval for the use of two alternative patient labels with the Dornier Compact Delta and Compact S Lithotripters.
P960009|S006|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/24/1999|03/25/1999|||APPR|Approval for corrections to an educational brochure which contains instructions for routing and implantation of the lead to extension connection and the addition of a new warning label.
P950029|S005|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/1999|08/25/1999|||APPR|Approval for access to programmable rest-rate and non-invasive physiological stimulation (NIPS) parameters.  The device is indicated for dual-chamber cardiac pacing with the ability to perform limited non-invasive electrophysiological studies.
P860004|S042|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED IMPLANTABLE INFUSION PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|02/26/1999|03/18/1999|||APPR|Approval for addition of an alternate catheter port for use with the SynchroMed pump, Model 8508 CAP; Addition of an Application Specific Integrated Circuit (ASIC) buffer chip to the pumps hybrid to improve battery longevity; addition of another suture loop to the shield; change in the device name from SynchroMed(TM) to SynchroMed EL(TM); change in model numbers (new model numbers represent new SynchroMed EL Pumps); and change to labeling.
P970020|S011|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|02/26/1999|05/06/1999|||APPR|Approval for a 5-year post-approval study protocol for the ACS MULTI-LINK RX and OTW DUET(TM) Coronary Stent Systems.
P950037|S008|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|ACTROS+ FAMILY OF PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/1999|08/24/1999|||APPR|Approval for 1) Non-Invasive Programmed Stimulation (NIPS) feature to be unlocked; 2) Automatic Sensor Gain (ASG) feature to be allowed in Actros+ family; 3) Release of programmer software version B-H02.0.U; 4) Change of trade name of PMS 1000C programmer to EPR 1000PLUS; and 5) Use of the B-H02.0.U PCMIA software cartridge with TMS1000 Tachyarrhythmia Monitoring System (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS.
N18033|S032|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|MOLDED ETAFILCON A SOFT CONTACT LENSES|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/1999|03/16/1999|||APPR|Approval for an alternate shelf-life protocol.
P940008|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RES-Q MICRON ADVANTAGE||CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|03/02/1999|03/31/1999|||APPR|
P980035|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953-SERIES 1.1 SOFTWARE||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/1999|04/01/1999|||APPR|Approval for the Medtronic.Vision Software Models 9953 and 9953A (Series 1.3) for use with the Medtronic Model 9790 programmers to program the Medtronic Kappa 700 series pacemakers.  The device, as modified, will be marketed under the trade name Medtronic.Vision Software Models 9953/9953A and is indicated for use with the Medtronic Kappa 700 series pacemakers to allow electrophysiology stimulation (EPS) functions.
P860019|S154|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|ADANTE PTCA CATHETER|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/1999|04/05/1999|||APPR|Approval for the ADANTE(TM) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (20 mm length with balloon diameters of 1.5 mm, and 2.0 -4.0 mm in 1/4 mm increments, and 30 and 40 mm lengths with balloon diameters of 2.0 - 4.0 mm in 1/4 mm increments).  The ADANTE(TM) PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocaridal perfusion.  The ADANTE(TM) PTCA Catheter (balloon models 2.5 - 4.0 mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents.
P940031|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY & MERIDIAN PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/1999|05/06/1999|||APPR|Approval for the introduction of an alternative lid for the accelerometer (to metal from ceramic) and the use of a silver thermoplastic to bond the accelerometer to the hybrid instead of epoxy.
P870015|S031|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS-T LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/1999|03/11/1999|||APRL|Approval for minor software upgrades to version 1999.0, minor hardware changes, and associated changes to the device labeling.
P980003|S001|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|03/03/1999|06/14/1999|||APPR|Approval of proposed postapproval study for the Chilli(R) Cooled Ablation System for Ischemic Ventricular Tachycardia.
P960013|S005|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|LOCATOR STEERABLE STYLET|DTB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/1999|04/09/1999|||APPR|Approval for changes to the User's Manual and package label for the Locator(TM) Steerable Stylet Model 4036.
P970043|S002|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADAR VISION EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/1999|12/03/1999|||APPR|Approval to modify the current labeling by 1)updating the clinical results with 12-month data; 2)presenting the 12-month data stratified into three groups (low myopia, low myopia with astigmatism, and high myopia with and without astigmatism)  based on preoperative refractive error, and 3) including new contrast sensitivity claims based on a contrast sensitivity study of 284 pts.  Other modifications to the labeling include editorial changes, the addition of new data tables reformatted to reflect the revised stratification of data, and the inclusion of a revised contrast sensitivity labeling statement to read:  "In a constrast sensitivity study designed to assess theeffects of LADARVision surgery on how well patients can see in conditions such as very dim light, rain, snow, fog or glare from bright lights at night, the percentages of patients showing clinically significant losses were 10.6% at 6 months and 6.6% at 12 months after surgery, and the percentages of patients showing clinically significant improvements were 5.9% at 6 months and 3.3% at 12 months after surgery."
P910001|S015|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXTREME XTO .9 MM CORONARY ANGIOPLASTY CATHETER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1999|07/11/2000|||APPR|APPROVAL FOR THE EXTREME 0.9 MM CORONARY ANGIOPLASTY CATHETER.
P900061|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/1999|12/02/1999|||APPR|Approval for the Medtronic(R) Model 7227 GEM(TM) Implantable Cardioverter Defibrillator with Connector Configuration Modules 5227B, 5227D, and 5227E.
P980035|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/1999|08/09/1999|||APPR|Sigma family of pulse generators & software. The DR & SR series are indicated for rate adaptive pacing in pts who may benefit fr   increased pacing rates concurrent w/increases in activity. The DR & D Series, SR & S Series, & VVI series are indicated for accepted pt     conditions warranting chronic cardiac pacing which include:Symptomatic paroxysmal or permanent second- or third-degree AV block; Symptomatic bilateral bundle branch block; Symptomatic paroxysmal or transient sinus node dysfunctions w/or w/o associated AV conduction disorders; Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.The DR & D series pacemakers are also indicated for dual chamber & atrial tracking modes in pts whomay benefit fr maintenance of AV synchrony.Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include:Various degrees of AV block to maintain the atrial contribution to cardiac output; VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. The pulse generator, Medtronic.Sigma(TM) Model SVDD303 Pulse Generator is indicated for the following: accepted patient conditions warranting chronic cardiac pacing which includes: Symptomatic paroxysmal or permanent second- or third-degree AV block; Symptomatic bilateral bundel branch block.  These pacemakers are also indicated for dual chamber & atrial tracking modes in pts who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include: various degrees of AV block to maintain the atrial contribution to cardiac output; VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.  The VDD Series pacemakers are also indicated for VDD modes in pts having adequae atrial rates & various indications.
P920023|S008|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESIS DELIVERY TOOL|MES|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/1999|04/13/1999|||APPR|Approval for a windowless version of the UroLume(R) Endoprosthesis delivery tool.
P960057|S006|WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON-L ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/1999|04/21/1999|||APPR|Approval for extending the expiration dating for ADCON-L Adhesion Control in a Barrier Gel syring configurations from 6 months to 12 months.  The device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
P860019|S155|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA CATHETER|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/1999|04/09/1999|||APPR|Approval for minor labeling revisions to the Instructions for Use manual for the Scimed(R) PTCA Catheters.
N50510|S086|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 SYSTEM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/1999|06/24/1999|||APPR|Approval for software revisions for major modifications to the design of the device in order to automate manual operations and enhance performance.  The device as modified will be marketed under the trade name VITEK(R) 2 System and is intended as a laboratory aid in the determination of the in vitro susceptibility of bacteria when tested on a Gram Negative Susceptibility Test Card or a Gram Positive Susceptibility Test Card containing antimicrobial agents at selected concentrations.
P920014|S008|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE IP LVAS|DSQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/17/1999|03/25/1999|||APPR|Approval to modify section 9.6 of the current directions for use to include instructions for adding an additional retaining suture from the Outflow Graft Screw Ring to the Outflow Elbow Screw Ring to secure the outflow graft and outflow conduit.
P980015|S002|INNOVATIVE MEDICAL SYSTEMS, INC.|3610 OAKDALE DRIVE||MOUNTAIN BROOK|AL|35223||Device, needle destruction|SHARP NEEDLE DESTRUCTION UNIT|MTV|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/1999|03/19/1999|||APPR|Approval for the modifications of the device circuitry.
P850079|S030|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/11/1999|04/15/1999|||APPR|Approval for an alternate tinting process, In-Monomer-Tinting Process.
P970003|S019|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/1999|04/05/1999|||OK30|The 30-Day Notice requested relocation of the Seam Welding Equipment from the Webster, Texas manufacturing facility to the existing Houston, Texas (Space Center) manufacturing facility.
P810046|S198|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS OTW PHOTON CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/1999|06/04/1999|||APPR|The device is indicated for:  1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.
P910073|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK ENDURANCE EZ ENDOCARDIAL DIFIBRILLATION LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/1999|06/15/1999|||APPR|The device is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for AICS automatic implantable cardioverter defibrillator systems.
P970003|S020|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/1999|04/05/1999|||OK30|The 30-Day Notice requested relocation of the Feed Through Welding Equipment fromt he Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility.
P970003|S021|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/1999|04/05/1999|||OK30|The 30-Day Notice requested relocation of the Laser Marking Equipment from the Webster, TX manufacturing facility to the existing Houston, TX (Space Center) manufacturing facility.
P880086|S060|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3510 PROGRAMMER/ 3303 SOFTWARE|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/1999|04/21/1999|||APPR|Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software.  The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers.
P830045|S064|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3510 PROGRAMMER/3303 SOFTWARE|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/1999|04/21/1999|||APPR|Approval for the Model 3510 Programmer with Model 3303 version 1.02 Software.  The device, as modified, will be marketed under the trade name the Model 3510 Programmer with Model 3303 version 1.02 Software and is indicated for the programming and interrogation of implanted St. Jude Pacemakers.
P920047|S012|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134|||EPT-1000 CARDIAC ABLATION SYSTEM||CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/1999|03/30/1999|||APPR|Approval for a new technique for bonding the proximal to distal segment of the catheters.
P970034|S003|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|UV-PMMA PCL'S|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/1999|04/16/1999|||OK30|The 30-day Notice requested introduction of a manufacturing process change to use an alternate sterilization chamber (chamber #1) at Griffith MicroScience, the same sterilization contractor approved in the original PMA.  Griffith is upgrading the chamber that was previously used.  The proposed cycle is nearly identical to the currently-approved cycle for chamber #8, both chambers will use the computer-controlled process; the primary differences are that the chamber is smaller and an additional air wash with vacuum hold have beed added after the gas-dwell phase.
P940022|S011|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION DEVICE FITTING SOFTWARE (SCLIN)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/24/1999|07/16/1999|||APPR|Approval for the modifications to the Device Fitting Software for adults and pediatrics.  The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.
P960058|S010|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION DEVICE FITTING SOFTWARE (SCLIN)||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/24/1999|07/16/1999|||APPR|Approval for the modifications to the Device Fitting Software for adults and pediatrics.  The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.
P890012|S004|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/1999|09/12/2000|||APPR|APPROVAL FOR 1) A CHANGE IN MANUFACTURING METHOD FROM LATHE-CUT TO CAST-MOLDED; 2) A CHANGE IN HANDLING TINT FROM VAT DYES TO D & C GREEN #6; 3) TO ADD AN ULTRAVIOLET ABSORBER INTO NETRAFILCON A LENS MATERIAL; 4) AN ALTERNATE MANUFACTURING SITE AT WESLEY JESSEN PBH, LTD., SOUTHAMPTON, UNITED KINGDOM; 5) MODIFICATION TO THE INDICATINOS FOR USE INCLUDING THE SENTENCE "GENTLE TOUCH(TM) UV (NETRAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES HELP TO PROTECT AGAINST THE TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE"; AND 6) MODIFICATION OF THE NOTE AND WARNING IN LABELING.
P910065|S001|TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ST AIA-PACK PA|LTJ|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/1999|09/10/1999|00M-1523|09/21/2000|APPR|Approval for the AIA-PACK PA.  The device is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA System analyzers.  This device is indicated for the measurement of serum PSA in conjunction with Digital Rectal Examination (DRE) as an aid in the detection of prostate cancer (CaP) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer.  The device is further indicated for the serial measurement of PSA in human serum to be used as an aid in the management of patients with prostatic cancer.
P950032|S009|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF TM|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/1999|04/19/1999|||OK30|The 30-day Notice requested a manufacturing process change for Apligraf(TM).  The requested change will place into the manufacturing process 3 additional production-scale incubators manufactured by Lunaire Corporation (model #CI0641W-6SPL).
P960020|S001|UROMED CORP.|64 A ST.||NEEDHAM|MA|02194||Transurethral occlusion insert, urinary incontinence-control, female|RELIANCE URINARY CONTROL INSERT & SIZING DEVICE|OCK|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|03/17/1999|04/01/1999|||APPR|Approval for suspension of postapproval study because company is discontinuing manufacture and distribution of device.
P950018|S003|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON (TM)|LWL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/1999|10/12/1999|||APPR|Approval for a manufacturing site located at Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 76134-2099.
P970051|S005|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (2-METER INTRA-OPERATIIVE CABLE|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/1999|05/12/1999|||APPR|Approval for a longer two meter cable for use with the H58 handset in the Nucleus 24 Cochlear Implant System.
P870056|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/1999|04/13/1999|||OK30|The 30-day notice requested the following manufacturing changes:  1) Modify the environmental classification for the area in which wireforming operations are performed.  2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly.
P870077|S009|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/1999|04/13/1999|||OK30|The 30-day notice requested the following manufacturing changes:  1) Modify the environmental classification for the area in which wireforming operations are performed.  2) Add a validated cleaning process for the wireform in a class 10,000 environment prior to stent assembly.
P860057|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/1999|04/13/1999|||OK30|The 30-day notice requested the following manufacturing changes:  1) Modify the environmental classification for the area in which wireforming operations are performed.  2) Add a validated cleaning process for the wireform in a class 10,000 environmental prior to stent assembly.
P970029|S001|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|ECLIPSE TMR HOLMIUM LASER SYSTEM|MNO|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|03/26/1999|09/17/1999|||APPR|Approval for a proposed post-approval study protocol.  In addition, all advertising and promotional materials must include the warning aobut the use of TMR in a patient with unstable angina, the need for patients to sign a consent form and the requirements that apply to the training of practitioners who may use the device.
P970020|S012|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/1999|04/22/1999|||OK30|The 30-Day Notice requested that "end-product" pyrogen testing be performed on non-sterile samples prior to E-beam sterilization, in addition to the current method of testing sterile samples.
P960011|S002|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON TM|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/1999|07/01/1999|||APPR|Approval for the use of a new packaging suite and for the use of a semi-automatic provess for assembly and labeling of the BioLon(TM) syringes.
P900043|S015|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/1999|09/14/1999|||APPR|Approval to market a new stent system.  The device is indicated for improving coronary luminal diameter in the following:  Patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary arteries (length < 30 mm) with a reference vessel diameter of 3.0 to 4.0 mm.  Long term outcome (beyond 6 months) for this permanent implant is unknown at present.
P910023|S041|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|VENTRITEX CONTOUR II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1999|04/19/1999|||APPR|Approval for an extension of the shelf life from 9 months to 18 months for the Contour(R) MD Model V-175 and the Contour(R) II Model V-185 Implantable Cardioverter Defibrillators.
P910023|S042|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|VENTRITEX CONTOUR II/MD; ANGSTROM II/MD; PROFILE II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/1999|04/19/1999|||APPR|Approval for a labeling change to reflect compatibility of the Contour II/MD, Angstrom II/MD, and Profile II/MD implantable defibrillators with cellular phones.
N80535|S009|INGREDION INCORPORATED|10 FINDERNE AVENUE|SUITE C|BRIDGEWATER|NJ|08807||POWDER, DUSTING, SURGICAL|ABSORBO HP-ABSORBABLE DUSTING POWDER|KGP|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/1999|07/16/1999|||APPR|Approval for revised labeling.  The request to replace the warning statement:  "WARNING-The Powder Should Be Washed Off Gloves with Sterile Solution Before Treated Gloves Are Used In Surgery," with the statement:  "Caution: After donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective method," is acceptable.
P970003|S022|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/1999|05/05/1999|||APPR|Approval for the Model 101 NCP Pulse Generator (for use with Model 201 NCP Programming Wand and Model 250 NCP Programming Software Version 4.4).
P980016|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||GEM II DR MODEL 7273||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/1999|04/15/1999|||APPR|Approval for screening the Medtronic(R) Model 7271 GEM(TM) II Dual Chamber Implantable Cardioverter Defibrillators for premature battery depletion.
P900061|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM MODEL 7227 CX ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/1999|04/15/1999|||APPR|Approval to implement a new test Method and specification for screening the Medtronic(R) Model 7227 Cx GEM(TM) Implantable Defibrillators for premature battery depletion.
P960030|S005|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/1999|08/26/1999|||APPR|Approval for the Model 1336T Passive Plus(R) DX Endocardial, Steroid Eluting, Passive Fixation pacing lead.  This device is indicated for permanent pacing and sensing of the ventricle when used with a compatible pulse generator.
N18033|S033|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE (ETAFILCON A) CONTACT LENS|LPM|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/1999|05/05/1999|||APPR|Approval for a change in the indications statement to add the sentence "ACUVUE UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye;" and modified Note and Warning.
P900023|S028|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/1999|11/24/1999|||APPR|Approval for a 10mm Arterial Cannula with 10mm Hemashield(R) woven graft.
P900023|S029|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/1999|05/19/1999|||APPR|Approval to modify the Operator's Manual to add information about transporting a patient to another institution while on BVS 5000 support, and to add information about the console display that has occurred during weaning from the device.
P830037|S042|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL SOFT HYDROPHILIC CONTACT LENSES|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/07/1999|05/07/1999|||APPR|Approval for the following:  1) minor modification of the polymer formulation to include changes in the ratio of ingredients; 2) configuration change to include a bifocal design for the device; 3) modifications to the labeling to include the presbyopic indication and add the sentence "FreshLook(R) Lenses with UV-absorbing monomer help protect against the transmission of harmful UV radiation tot he cornea and into the eye"; 4) modification of the Note and Warning; 5) combining the package inserts for the bifocal, spherical and toric configurations; and 6) minor editorial changes to the spherical and toric indications.
P960043|S017|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/1999|05/05/1999|||APPR|Approval for modifications to the labeling and placement of the outer package label.
P930038|S018|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/1999|04/27/1999|||APPR|Approval for a modification to the collagen sponge shape.
P950015|S002|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|THE HEART LASER CO2 TMR SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/1999|04/27/1999|||APPR|Approval for changes to the labeling.
P940015|S003|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC (HYLAN G-F 20)|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/1999|12/20/1999|||APPR|Approval for a labeling change in the Physician Package Insert to reflect information in the Patient Package Insert regarding the time of maximum treatment effect.
N18286|S011|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM ABSORBABLE GELATIN POWDER|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/05/1999|04/26/1999|||APPR|Approval for changing the name of the product form Gelfoam Sterile Powder to Gelfoam Absorbable Gelatin Powder.
P950035|S004|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM|GZC|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/1999|05/18/1999|||APPR|Approval for the following: 1) Changing the manufacturing site for the Epimysial Probe, Anode Plate, and Epimysial Electrode to Lewicki Microelectronic, GmbH; 2) Changing the site for packaging and sterilization of the Freehand System Electrode Positioning Kit and Epimysial Electrode to Lewicki Microelectronic , GmbH; 3) Addition of two paper measuring tapes to the Electrode Positioning Kit; 4) Changing the materila used to support the Anode Plate and the coating over this material; 5) Changing the material used to coat the weld of the Epimysial Electrode; 6) Changing the vendor for the connector pin, strain relief springs, and center springs of the Implantable Connector of the Epimysial Electrode; 7) Changing the manufacturing procedures, packaging, and sterlization process; and 8) Changing the labeling to include symbols that conform to European CE Marketing requirements.
P950032|S010|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/1999|05/03/2000|||APPR|Approval for a change in the source and composition of the Apligraf growth media.
P850079|S031|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY 55 UV (SPHERICAL & TORIC ) SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/1999|07/28/1999|||APPR|Approval for the Frequency(TM) 55 UV lens in spherical and toric configuration for extended wear.
P980003|S002|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/1999|05/06/1999|||APPR|Approval for hardware and software changes made to support a single board computer, as well as software changes to allow the use of user-selected flow rates for the pump.
P970051|S006|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/1999|05/07/1999|||OK30|The 30-day Notice requested a manufacturing process change from Freon to Lenium TS for use in the expansion of silicone tubing and moldings.
P840024|S078|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (ADULT)|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/1999|05/07/1999|||OK30|The 30-day Notice requested a manufacturing process change from Freon to Lenium TS for use in the expansion of silicone tubing and moldings.
P890027|S047|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (CHILDREN)|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/1999|05/07/1999|||OK30|The 30-day Notice requested a manufacturing process change from Freon to Lenium TS for use in the expansion of silicone tubing and moldings.
P970020|S014|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX AND OTW DUET CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/1999|05/14/1999|||OK30|The 30-Day Notice requested a change in the manufacturing operation for the stent systems packaging.
P780010|S021|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS (PERFILCON A)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/19/1999|05/12/1999|||APPR|Approval for a consolidated package insert.
P970053|S002|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Change Design/Components/Specifications/Material|Y|04/19/1999|04/14/2000|01M-0014|01/16/2001|APPR|INDICATIONS FOR USE OF THE NIDEK EC-5000 EXCIMER LASER SYSTEM.
P950019|S008|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/1999|10/04/1999|||APPR|Approval for the Ray TFC(TM) Unite Device, a modified version of the approved Ray TFC(TM).
P970061|S007|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||SCIMED RADIUS CORONARY STENT||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/1999|09/17/1999|||APPR|Approval for the addition of a centerless grinding process to widen trace element nitinol tubing material.
P890023|S007|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/1999|05/10/1999|||APPR|Approval for the addition of a ultraviolet blocker into the matrix of the Biomedics 55 (ocufilcon D) soft (hydrophilic) lens for extended wear, a change in the indications statement to add the sentence "Biomedics UV Blocking Contact Lenses help protect against transmission of harmful UV radiation ot the cornea and in the eye;" and a modified Warning and Note.
P970035|S014|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S670 OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/1999|11/16/1999|||APPR|Approval for the Medtronic AVE (AVE) S670 with Discrete Technology(TM) Over-The Wire Coronary Stent System.  The device is indicated for improving coronary luminal diameter in patients with symptomiatic ischemic heart disease due to discrete de novo lesions (length <30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm.  Long term outcome (beyond 14 days) for this permanent implant is unknown at present.
P860057|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS|DYE|CV|Panel Track|Change Design/Components/Specifications/Material|N|04/22/1999|08/28/2000|00M-1483|09/11/2000|APPR|APPROVAL FORTHE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 6900 MITRAL, SIZES 25, 27, 29, 31, AND 33 MM.  THIS DEVICE IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC MITRAL VALVE.
P860005|S011|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES|MBS|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/1999|05/25/1999|||APPR|Approval for updated labeling that reflects the results of the completed post-market approval study.
P960043|S018|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/1999|05/26/1999|||APPR|Approval for the use of an additional package label identifying the sterile barrier.
P910023|S043|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|VENTRITEX HOUSECALL RECEIVER/TRANSMITTER|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1999|08/04/1999|||APPR|Approval for the transtelephonic follow-up system.  The device, as modified, will be marketed under the trade name Housecall(TM) 2.0 system and is indicated for use with the Ventritex(R) Tiered-Therapy Defibrillators.
P970035|S015|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S670 RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1999|11/23/1999|N||APPR|The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length <30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm.  Long term outcome (beyond 14 days) for this permanent implant is unknown at present.  The rapid exchange delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressue during the 15-30 second stent deployment procedure only.  The rapid exchange stent delivery system is not intended for use as a stand alone PTCA perfusion catheter.
P970035|S016|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/1999|05/14/1999|||OK30|The 30-Day Notice requested that GFX(R) ring components annealed at 985 degrees Celsius for 20 minutes be utilized for the manufacturing of the GFX2 stent component.  The change is being requested in order to utilize the existing inventory of GFX ring components for the manufacture of GFX2 stent.
P970020|S015|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACA MULTI-LINK & DUET CSS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/1999|05/20/1999|||OK30|30-day Notice to modify the process by which the stents are passivated and include four other minor changes.
P980001|S006|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIROYAL ADVANCE PREMOUNTED STENT SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/1999|05/24/2000|||APPR|Approval for the NIROYAL Advance Premounted Stent System.
P950032|S011|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/1999|06/24/1999|||APPR|Approval to use a new keratinocyte cell strain (i.e., HEP 608) in the manufacture of Apligraf.
P850048|S013|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/1999|06/16/1999|||APPR|Approval for an alterante manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN  55318.
P970038|S002|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY|MTG|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/1999|06/16/1999|||APPR|Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318.
P970043|S003|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADAR VISION EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/1999|05/12/1999|||APPR|Approval for labeling changes (i.e., minor editorial changes and the addition of a precaution statement to the Patient Information Booklet, Physicians' Booklet, and System Operation Manual.  The System Operation Manual also included some revised instructions for use, including directions to follow in the event of a power interruption before or during treatment).
P940015|S004|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC (HYLAN G-F 20)|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/03/1999|05/26/1999|||APPR|Approval for labeling changes to the Physician Package Insert.  The device, as modified, will be marketed under the trade name Synvisc(R) (Hylan G-F 20) and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen.
P850089|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSURE SP NOVUS|DTB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/03/1999|06/11/1999|||APPR|Approval for labeling changes to the Technical Specification manuals for the CapSure(R) Z Novus Model 5554 and CapSure(R) SP Novus Model 5592 pacing leads.
P960043|S019|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||CLOSER PERCUTANEOUS VASCULAR SURGERY DEVICE||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/1999|11/22/1999|||APPR|Approval for the Closer(TM) PVS Device and the following accessories:  the Perclose Mini Knot Pusher, Perclose Snared Knot Pusher and the Clincher(TM) Knot Tying Device.  The device is indicated for the percutaneous delivery of suture for closing hte common femoral artery access sie of patients who have undergone diagnostic catheterization procedures using 5 to 6 Fr. sheaths.  The Closer(TM) 6 Fr. PVS System reduces the times to hemostasis, ambulation (5 meters or 16 feet) and discharge in patients who have undergone diagnostic catherization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations in the device labeling).
P950019|S009|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY TFC DEVICE AND RAY TFC UNITE DEVICE|MAX|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/03/1999|03/02/2000|00M-1212||APPR|Modified indications for use for the Ray TFC and Unite Threaded Fusion Cage with instrumentation.  These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (DDD) at one or two levels for L2 to S1.
P830039|S010|MEDICALCV, INC.|9725 SOUTH ROBERT TRAIL||INVER GROVE HEIGHTS|MN|55077||HEART-VALVE, MECHANICAL|OMNISCIENCE CARDIAC VALVE|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/04/1999|10/29/1999|||APPR|Approval for modifications to the Omni-Series Instructions for Handling and Use.
P960016|S001|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM-ADDITION OF LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/06/1999|06/18/1999|||APPR|Approval for four curve versions of the TC(TM) catheter line with increased lateral stability, known as the XLS(TM) series.
P980001|S008|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PRIMO PREMOUNTED STENT SYSTEM||CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/1999|06/11/1999|||APPR|Approval for a change in the specification of the balloon component for the NIR(TM) Primo(TM) Premounted Stent System.  This change applies only to the 9 mm length NIR(TM) Primo(TM) Premounted Stent System with the 3.0 mm, 3.5 mm, and 4.0 mm balloon diameters.
P830055|S061|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM-ADDITION OF ROTATING PLATFORM TIBIAL TRAY WITH KEEL|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/1999|05/19/1999|||APPR|Approval for the addition of the Rotating Platform Tibial Tray with Keel to the LCS(R) Total Knee System.
P940034|S010|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121|||GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/1999|05/25/1999|||OK30|30-day Notice for the following changes: revised performance specifications for specific materials and the addition of qualified vendors; and implementation of additional in-process qualification procedures for testing oligonucleo tide materials.
P960057|S008|WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON-L ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/1999|06/02/1999|||APPR|Approval for new quality control measures and is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
P900060|S019|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|SULZER CARBOMEDICS CPHV OPTIFORM VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/1999|06/01/1999|||APPR|Approval for a sewing cuff modification of the CarboMedics(R) Prosthetic Heart Valve.  The device, as modified, will be marketed under the trade name CPHV(TM) OptiForm(TM) Valve and will be available in the following model numbers and sizes:  Aortic Model F500 (sizes 19, 21, 23, 25, 27, 29, and 31 mm), and Mitral Model F700 (sizes 21, 23, 25, 27, 29, 31, and 33 mm).  The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves.
P950037|S009|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|ACTROS DR+ -B PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/1999|06/07/1999|||APPR|Approval for the B-H00.O.U Software module for use with the Biotronik PMS1000 series programmers, and the Actros DR+-B with dual 6mm header ports.
P950015|S003|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|HEART LASER CO2 TMR SYSTEM|MNO|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/14/1999|11/10/1999|||APPR|Approval for a new study protocol, having both an accelerated aging and a real time aging arm, to demonstrate a two year shelf life for the TMR Disposable Kit (an accessory for The Heart Laser(TM) System).  In addition, approval is requested to extend the shelf life for the TMR Disposable Kit from one year to two years, based on results of the accelerated aging portion of the proposed new protocol.
P950014|S018|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/1999|05/19/1999|||APPR|Approval for upgrades to the Prostasoft software to version 4.02.
P970038|S003|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY|MTG|IM|Normal 180 Day Track|Express GMP Supplement|N|05/14/1999|06/16/1999|||APPR|Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318.
P910068|S001|AIR PRODUCTS & CHEMICALS, INC.|7201 HAMILTON BLVD.||ALLENTOWN|PA|18951|501|Fluid, intraocular|VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)|LWL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/1999|04/04/2001|||APPR|APPROVAL FOR  1) MANUFACTURING SITE CHANGE:  THE NEW SITE FOR MANUFACTURING THE BULK MEDICAL GRADE PERFLUOROPERHYDROPHENANTHRENE (APF-215M) WILL BE AT FLUOROMED, L.P. (FMLP), ROUND ROCK, TEXAS 78664;  2) MANUFACTURING CHANGE: APF-215M WILL BE MANUFACTURED FROM PERFLUOROPERHYDROPHENANTHRENE RAW MATERIAL INSTEAD OF FROM PHENANTHRENE RAW MATERIAL; AND  3) APF-215M SPECIFICATION CHANGE REGARDING TESTING PARAMETER FOR LOWER BOILING COMPONENTS.
P890055|S010|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/1999|05/27/1999|||APPR|Approval for the following modifications to the device:  1)Replacement of the standard 50 ml syring with a calibrated syringe in the refill kit and related labeling; 2) the incorporation of a special bolus winged infusion set; 3) Increase the volume of water placed into the pump reservoir prior to sterilization; 4) Revise the labeling to refer the user to the instruction for use of the device.
P900043|S016|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY OVER THE WIRE DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/1999|05/27/1999|||APPR|Approval for the addition of a label to the outside front panel of the MiniCrown carton that states the following:  "Do not induce a vacuum on the delivery system prior to reaching the target lesion."
P850048|S014|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/1999|06/16/1999|||APPR|Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Dr., Chaska, MN 55318.
P980035|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC VISION SOFTWARE (MODEL 9953A)||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/1999|06/11/1999|||APPR|Approval for a modification to the Medtronic.Vision Model 9953A Series 1.3 Software, used with the Model 9790 Programmer, to correct a software installation anomaly.
P950043|S006|MEDISPEC, LTD.|19110 MONTGOMERY VILLAGE AVE.|SUITE 100|MONTGOMERY VILLAGE|MD|20886||Lithotriptor, extracorporeal shock-wave,urological|ECONOLITH LITHOTRIPTER|LNS|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|05/19/1999|08/27/1999|||APRL|Approval for the final report of the postapproval study regarding the possible relationship between extracorporeal shcok wave lithotripsy and the onset of hypertension, and 2) modifications tothe Econolith(TM) Lithotripter's labeling to reflect the results of the final report.  Based upon the information submitted, FDA believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that the postapproval requirement is now complete.
P960016|S002|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/20/1999|11/15/1999|||APPR|Approval for eight new catheters marketed under the trade name Livewire TC(TM) Steerable Electrophysiology Catheter with Universal Temperature Monitoring and the Livewire TC(TM) Steerable Electrophysiology Thermistor Extension Cable.  The device is indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for:  interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.
P900056|S027|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/1999|06/16/1999|||APPR|Approval for a labeling change for the Rotablator System.
P880086|S061|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|AFFINITY DR & DC; ENTITY DR & DC|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/1999|06/17/1999|||APPR|Approval to distribute various pulse generators.
N50510|S087|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-AMPICILLIN/SULBACTAM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1999|07/09/1999|||APPR|Approval for the removal of a limitation for the testing of Enterobacter cloacae with the antibiotic ampicillin/sulbactam.
N50510|S088|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-CEFTRIAXONE|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1999|07/12/1999|||APPR|Approval for the removal of a limitation for the testing of Klebsiella spp. with the antibiotic ceftriaxone.
N50510|S089|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK GRAM POSITIVE SUSCEPTIBILITY FOR OXACILLIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1999|07/26/1999|||APPR|Approval for the addition to the VITEK(R) Gram Positive Susceptibility Panels, the antibiotic oxacillin at equivalent concentrations of 0.5, 2, and 5 ug/ml.
P950022|S006|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|VENTRITEX TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/1999|11/23/1999|||APPR|Approval for the TVL-ADX Model 1559 Tachyarrhythmia Lead System.
P960001|S008|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|BONE CEMENT|DEPUY 1 AND ENDURANCE BONE CEMENTS|LOD|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/1999|09/01/1999|||APPR|Approval for minor labeling changes: 1) change the package insert labeling for DePuy 1 Bone Cement from multilingual to English only; and 2) change to the package labeling for DePuy 1 and Endurance Bone Cements to remove reference to pack sizes that are approved but not currently marketed.
P960004|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FINELINE|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/14/1999|07/01/1999|||APPR|Approval for the ThinLine(TM) pacing leads under the Guidant FINELINE(TM) trade name.  These devices are indicated for permanent pacing and sensing in the ventricle and/or the atrium when used with a compatible pulse generator.
P880086|S062|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|AFFINITY SR/DR|KRG|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/1999|06/21/1999|||OK30|The 30-Day Notice requested elimination of redundant testing in the Affinity pulse generator manufacturing process.
P930021|S002|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN|NQA|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/26/1999|07/23/1999|||APPR|Approval for revised labeling.
P930021|S003|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN|NQA|DE|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/1999|08/24/1999|||APPR|Approval for packaging changes for EMDOGAIN(R).  The following packaging changes are now approved:  1) a change in the size of the glass vial in which the EMDOGAIN powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10 mg of the product in addition to the originally approved 30 mg of the product.
P900061|S038|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/1999|06/16/1999|||APPR|Approval to revise the circuitry of the high power hybrids used in the Model 7227Cx GEM(TM) and the Model 7273 GEM(TM) II DR implantable cardioverter defibrillators to correct the premature low battery problem.
P980016|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC MODEL 7273 GEM II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/1999|06/16/1999|||APPR|Approval to revise the circuitry of the high power hybrids used in the Model 7227Cx GEM(TM) and the Model 7273 GEM(TM) II DR implantable cardioverter defibrillators to correct the premature low battery problem.
P830061|S030|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSURE SP NOVUS MODEL 4092 VITATRON EXCELLENCE PS+ MODEL IMK 49B TRANVENOUS VENTRICULAR LEAD|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/24/1999|06/16/1999|||APPR|Approval for a tine design change for the Model 4092 and IMK49B leads.
P980001|S009|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEMS||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/1999|07/01/1999|||APPR|Approval for the additional sterilization facility located at Griffith Micro Sciences, Park Industrial De Petit Rechain, Verviers 4800, Belgium.
P980023|S002|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/01/1999|09/13/1999|||APPR|Approval for device hardware and software modifications.  The device, as modified, will be marketed under the trade name mycroPhylax(Plus), Phylax XM, and TMS 1000(Plus) Tachyarrhythmia Monitoring System.  The devices are indicated for use in patients who are at risk of sudden death due to ventriular arrhythmias and have experienced one of the following situations:  survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmias; or recurrent poorly tolerated sustained ventricular tachycardia (VT).
P890003|S058|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|REVEAL PLUS INSERTABLE LOOP RECORDER MODEL 9809 SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/1999|12/27/1999|||APPR|The device is indicated for the programming of the adjustable parameters of the implantable recorder used in the device.
P940031|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/1999|06/29/1999|||APPR|Approval for an alternate manufacturing facility located at Guidant Ireland, Cashel Road, Clonmel Tipperary, Ireland and an alternate sterilization sited located at Isotron Ireland Ltd., Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland.
P960025|S001|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE WITH VSP SPINAL SYSTEM|MCV|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/1999|07/16/1999|||APPR|Approval for the packaging and distribution facility located at DePuy AcroMed, Inc., 325 Paramount Drive, Rayhnam, Massachusetts 02767.
P960052|S001|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND TOPICAL SKIN ADHESIVE|MPN|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/09/1999|02/15/2001|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO CLARIFY SAFE USE OF THE PRODUCT.
P870049|S029|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/10/1999|06/24/1999|||APPR|Approval for the addition of a limitation to not report results for the testing of Escherichia coli and Klebsiella spp. with the antibiotic ticarcillin/K clavulanate in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.
P910001|S016|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/14/1999|12/10/1999|||APPR|Approval for software modifications for the Power Error audible tone warning and Fault 10 display features.
P870015|S033|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|MEDSTONE STS-T LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/14/1999|06/21/1999|||APRL|Approval for use of an alternate ECG monitor, minor software upgrades to version 1999.2, and associated changes to the device labeling.
P930016|S010|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S2 AND S3 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|06/18/1999|10/18/2000|01M-0015|01/22/2001|APPR|THESE DEVICES ARE INDICATED FOR PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENTS:  IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D PER YEAR FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; ANDIN PATIENTS 21 YEARS OF AGE OR OLDER FOR THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +0.5 AND + 5.0 D SPHERE AT THE SPECTACLE PLANE WITH REFRACTIVE ASTIGMATISM FROM +0.5 TO +4.0 D WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D.
P970020|S017|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX/OTW TRISTAR CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1999|12/22/1999|||APPR|Approval for the ACS Multi-Link RX and OTW Tristar(TM) Coronary Stent Systems.
P970058|S004|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|THE IMAGECHECKER SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/1999|09/02/1999|||APPR|Approval for new software that places circle markers around correlated mass markers.
P830055|S062|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/21/1999|07/22/1999|||APPR|Approval for the addition of apolyethylene replacement bearing for metal-backed patella components to the LCS(R) Total Knee System.
P900056|S028|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/1999|08/09/1999|||OK30|The 30-Day Notice requested the use of alternate biological indicators with a reduced incubation time.
P960004|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINELINE/FINELINE II ENDOCARDIAL PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/1999|01/07/2000|||APPR|
P850020|S012|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA TREATMENT COLUMN FOR RA AND ITP|LKN|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/21/1999|12/17/1999|||APPR|Approval of post-approval study protocols.
P880086|S063|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/1999|07/21/1999|||APPR|Approval for modifications to the Model 3303 V1.03 programmer software for use with the Models 3500/3510 Programmers.
P830045|S065|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/1999|07/21/1999|||APPR|Approval for modifications to the Model 3303 V1.03 programmer software for use with the Models 3500/3510 Programmers.
P970033|S001|MIRABEL MEDICAL SYSTEMS, INC.|9020-1 CAPITAL OF TEXAS HGWY|SUITE 390|AUSTIN|TX|78759||Imager, breast, electrical impedance|TS2000|NCL|RA|Normal 180 Day Track||N|06/23/1999|11/15/1999|||APPR|Approval for changes in the electronic circuitry, elimination of all but the 200 Hz frequency, optional small probe, and optional phantom.  The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within ACR BI-RADS(TM) categories 3 or 4.  In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy.  This device provides the radiologist with additional information to guide a biopsy recommendation.
P820075|S008|Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL OSMOTIC CERVICAL DILATOR|LOB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/1999|07/09/1999|||OK30|The 30-Day Notice requested a change in the approved sterilization process of e-beam to gamma radiation process.
P820075|S009|Medtronic Xomed, Inc.|6743 SOUTHPOINT DR. N.||JACKSONVILLE|FL|32216||dilator, cervical, synthetic, osmotic, pregnancy termination|LAMICEL OSMOTIC CERVICAL DILATOR|LOB|OB|Normal 180 Day Track|Express GMP Supplement|N|06/24/1999|07/16/1999|||APPR|Approval for a new sterilization facility located at Sterigenics Intl., Inc., 10811 Withers Cove Park Dr., Charlotte, N.C.
P970008|S012|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/1999|12/04/1999|||APPR|Approval for modifying the contraindications regarding use in patients with implants.
P920032|S005|PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE|MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER|JOQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/1999|02/02/2000|||APPR|Approval is for an alternate vendor located at Princeton Technology, Inc., 12 Park Avenue, Hudson, New Hampshire.
P930038|S019|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/1999|03/08/2000|||APPR|Approval for the 6F Angio-Seal(TM) Hemostatic Puncture Closure Device.  The device, as modified, will be marketed under the trade name 6F Angio-Seal(TM) Hemostatic Puncture Closure Device and is indicated for closing the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures using a retrograde approach and a 6 French or smaller procedureal sheath.  The Angio-Seal (TM) device reduces the times to hemostasis, ambulation and discharge in patients who have undergone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations).
P980012|S001|WORLD HEART, INC.|7799 PARDEE LN.||OAKLAND|CA|94621||Ventricular (assisst) bypass|NOVACOR LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/1999|12/21/1999|||APPR|Approval to introduce the Novacor LVAS Compact Controllers with AutoTuning Software.
P960016|S003|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION CATHETER|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/1999|12/13/1999|||APPR|Approval for a change in sterilization process from 12% EtO/88% CFC to 100% EtO (while at the same time transferring the sterilization to an outside contract sterilization facility).
P950015|S005|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER)|MNO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/1999|03/08/2000|||APPR|Approval for specific software revisions addressed to disarming the laser after it has fired and to resolving a minor Y2K problem.
P980006|S001|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/1999|08/25/1999|||APPR|Approval for a manufacturing site located at Bausch & Lomb Ireland, Contact Lens Plant, Unit 424/425, Industrial Estate, Cork Road, Waterford, Ireland.
P940007|S005|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/1999|07/30/1999|||APPR|Approval for changes to the Warning Section of the lens package insert.  Specifically:  "When implanting a lens with a smaller optic (less than or equal to 5.5mm), it is recommended that capsulorhexis, with a diameter smaller than the lens optic, be performed.  A thorough cortical cleaning before lens insertion is also recommended."
P970024|S003|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable cardioverter defibrillator (non-CRT)|ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT|LWS|CV|Normal 180 Day Track|Express GMP Supplement|N|07/01/1999|09/14/1999|||APPR|Approval for removal of patient monitoring for the capacitor part number 200068-106 of the post-approval requirement.
P880086|S064|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|ADDVENT/AV PLUS DX|DXY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/1999|07/23/1999|||APPR|Approval for an extension of the approved shelf life for the device including pulse generator Models 2060BL and 2060LR (12 to 18 months), and the Model 1368 Single Pass Lead (12 to 24 months).
P900043|S017|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH HEPACOAT OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1999|02/01/2000|||APPR|Additioin of a heparin coating on the PALMAZ-SCHATZ MiniCrown Balloon-Expandable Stent on Dynasty Over the Wire Delivery System
P820060|S013|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT ARCHITECHT AFP|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1999|02/02/2004|||APPR|APPROVAL FOR THE ADDITION OF THE AFP ASSAY ON THE ARCHITECT IMMUNOASSAY INSTRUMENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT AFP ASSAY AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN : 1) HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOSUS TESTICULAR CANCER.  2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (NTD).
P880086|S065|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TENDRIL/PASSIVE PLUS/AV PLUS DX|DXY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/1999|11/10/1999|||APPR|Approval for the use of two alternate medical adhesives.
P960030|S006|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL/PASSIVE PLUS/AV PLUS DX|DTB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/1999|11/10/1999|||APPR|Approval for the use of two alternate medical adhesives.
P960013|S006|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL/PASSIVE PLUS/AV PLUS DX|DTB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/1999|11/10/1999|||APPR|Approval for the use of two alternate medical adhesives.
P920031|S001|DADE BEHRING, INC.|PO BOX 6101||NEWARK|DE|19714|6101|CYCLOSPORINE|EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY|MKW|TX|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1999|08/11/2000|||APPR|APPROVAL FOR EMIT(R) CYCLOSPORINE SAMPLE PRETREATMENT REAGENT AND COBAS INTEGRA 700 CYCLOSPORINE.
N50510|S090|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1999|09/17/1999|||APPR|Approval for the addition of the antibiotic tobramycin to the Vitek(R) 2 Gram Negative Susceptibility Test System.  The device, as modified, will be marketed under the trade name Vitek(R) 2 and is indicated for use in the Vitek(R) 2 gram negative susceptibility panel for the susceptibility testing of gram negative isolates to tobramycin in the range of <1 to >16 ug/ml.
N50510|S091|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR CIPROFLOXACIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/1999|09/23/1999|||APPR|Approval for the addition of the antibiotic ciprofloxacin at concentrations of 0.5, 2 and 4 ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System.  the device, as modified, will be marketed under the trade name Vitek(R) 2 and is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to ciprofloxacin in the range of <0.25 to >4 ug/ml.
P920004|S010|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL  VHD|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/1999|08/10/1999|||APPR|Approval for a revision to the Instructions for Use.
P970019|S006|HEALTH TRONICS SURGICAL SERVICES, INC.|425 FRANKLIN RD., SUITE 545||MARIETTA|GA|30067||Lithotriptor, extracorporeal shock-wave,urological|LITHOTRON ULS|LNS|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/1999|12/17/1999|||APRL|Approval for addition of an ultrasonic stone location accessory.  The device is indicated for preliminary localization of a target stone prior to extracorporeal shock wave lithotripsy with the Lithotron(TM) Lithotripsy System.  The indications for use have not changed.
P880086|S066|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFFINITY/ENTITY DR,DC,SR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/1999|07/27/1999|||APPR|Approval for minor modifications to the firmware of the Affinity series of pulse generators.
P980016|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MODEL 7271 GEM DR ICD||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/07/1999|08/12/1999|||APPR|Approval for modifications to the high power circuitry of the Medtronic(R) Model 7271 GEM(R) DR Implantable Cardioverter Defibrillator.
P900009|S007|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|SONIC ACCELERATED FRACTURE HEALING SYSTEM|LPQ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/07/1999|08/25/1999|||APPR|Approval for a name change from SAFHS 2000(R) to Exogen 2000(R).  The device is indicated for the acceleration of the time to a healed fracture for fresh*, closed, posteriorly displaced distal radius (Colles') fractures, and fresh*, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.  *All fractures in both clinical studies were treated with SAFHS(R) therapy within seven days for fracture.
P940010|S007|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE CYLINDRICAL FIBER OPTIC|MVG|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/1999|08/13/1999|||APPR|Approval for revision ot the package labeling and package insert labeling.  The approved modifications include clarification of directions for use and device descriptions and simplification of use of trademark or registered trademark symbols.
P980001|S010|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/1999|07/22/1999|||OK30|The 30-Day Notice requested modification of the dimensions of two packaging components (packaging tube and balloon/stent protector) to allow for easier device removal.
P850089|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE SP NOVUS MODEL 5092 (AND VITATRON EXCELLENCE SS+ MODEL IML 49B)|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/09/1999|08/11/1999|||APPR|Approval for a tine design change for Model 5092 and IML 49B leads.
P830055|S063|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/1999|08/05/1999|||APPR|Approval to allow DePuy the option of manufacturing the LCS Rotating Platform Tibial Inserts, Meniscal Bearing Tibial Inserts and All Polyethylene Tibial Components from Ultra High Molecular Weight Polyethylene (UHMWPE) that is vacuum packaged in foil barrier bags and gamma sterilized (the GVF process).
P850022|S012|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/1999|07/26/1999|||APPR|Approval for addition of a 3x5-inch package insert (to be used as a daily patient reminder of the key elements of OrthoPak unit maintenance) into the case of every shipped OrthoPak(R) unit.  Each card contains the following information:  Bioelectron, Inc., 800-524-0677 Call this number for batteries, electrodes, questions or billing inquiries.  1) Change battery every morning. 2) Change electrodes every 3-7 days or when they will not stick to your skin.  Make sure yoru skin is clean and dry before applying new electrodes.
P970032|S001|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089|||SALEST SYSTEM||CH|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/1999|08/26/1999|||APPR|Approval for a contract packaging site located at Biotecnica Continental SA DE CV, Libramiento Oriente 124-C, Tijuana, BC 22490, Mexico.
P870024|S042|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens,contact(rigid gas permeable)-extended wear|VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)|MWL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/1999|01/31/2000|||APPR|Approval is for wet shipping and up to 30 day storage of the extended wear rigid gas permeable lenses in Alcon Wetting, Soakig, Conditioning and Disinfecting Solution ID 84392.
P850048|S015|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY|LTJ|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/1999|08/03/1999|||OK30|The 30-day Notice requested a change in a raw material from bovine serum to bovine serum albumin, which is used in the manufacture of a component in the Tandem(R)-MP PSA kit to improve the consistency between lots.  In addition, a change in the microplate vendor to permit an additional source of microplates and to reduce manufacturing costs.
N50510|S092|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/1999|11/05/1999|||APPR|Approval for the addition of the antibiotic trimethoprim/sulfamethoxazole at concentrations of 0.5/9.5, 2/38 and 16/304ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System.  The device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to trimethoprim/sulfamethoxazole in the range of <1/19 to >16/304ug/ml.
P970020|S018|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/1999|08/13/1999|||OK30|The 30-Day Notice requested the elimination of the pre-expansion step for the 3.0 mm, 3.5 mm, and 4.0 mm sizes.
P890017|S007|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLOON EXPANDABLE STENTS|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/1999|01/28/2000|||APPR|Approval is for additional models of the PALMAZ balloon expandable stent and the use of the OPTA LP and Powerflex Plus balloon catheters as delivery systems for the stents.  The additional stent models include stents with  an expansion range from 6 to 8 mm and lengths from 10 to 30 mm.
P920014|S009|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE IP & VE LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/1999|08/10/1999|||APPR|Approval to change the material of the retaining suture that TCI includes with each implant kit from Tevdek II 7-776 to #2 NOVAFIL(TM).
P820003|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EXTERNAL PULSE GENERATOR|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/1999|09/01/1999|||APPR|Approval for labeling changes for the Model 5388 External Pulse Generator.
P930038|S020|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/1999|12/08/1999|||APPR|Approval for the alternate manufacturing facility located at the Daig Corporation, 14901 DeVeau Place, Minnetonka, Minnesota  55345.
P900060|S020|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/1999|06/29/2000|||APPR|APPROVAL FOR THE USE OF A NITINOL LOCK WIRE AS AN ALTERNATIVE MATERIAL FOR THE SEWING CUFF ATTACHMENT MECHANISM OF THE PRODUCTS LISTED.
P910073|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/1999|09/29/1999|||APPR|Approval for a modified DF-1 terminal of the ENDOTAK(R) series of Endocardial Defibrillation Leads and the Model 6952 Lead Extender, which consists of a shorter terminal pin, a counter bore in the terminal pin, and a modified coil transition.
P880006|S029|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|REGENCY SC+, REGENCY SC, REGENCY SCX|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/1999|01/28/2000|||APPR|Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers.  The device is indicated for the programming and interrogation of implanted St. Jude pacemakers.
N50510|S093|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/1999|11/10/1999|||APPR|Approval for the addition of the antibiotic aztreonam at concentrations of 2, 8 and 32ug/ml tot he Vitek(R) 2 Gram Negative Susceptibility Test System.  The device is indicated ofr use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to aztreonam in the range of <1 to >64ug/ml.
N50510|S094|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/1999|10/07/1999|||APPR|Approval for the addition of the antibiotic amikacin at concentrations of 8, 16 and 64 ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System.  The device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to amikacin in the range of <2 to >64 ug/ml.
N50510|S095|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR CEFOTETAN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/1999|11/08/1999|||APPR|Approval for the addition of the antibiotic cefotetan at concentrations of 2, 8, and 32 ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System.  This device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testingo f gram negative isolates to cefotetan int he range of <4 to >64ug/ml.
P880086|S067|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|3500/3510 PROGRAMMER|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/1999|01/28/2000|||APPR|Approval is for the Model 3304 Programmer Software for use with the Model 3500 and 3510 Programmers.  The device is indicated for programming and interrogation of implanted St. Jude pacemakers.
P830045|S066|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|3500/3510 PROGRAMMER|KRG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/1999|01/28/2000|||APPR|Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers.  The device is indicated for the programming and interrrogation of implanted St. Jude pacemakers.
P940035|S002|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|MATRITECH NMP22 TEST KIT|NAH|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/1999|01/18/2000|00M-1522|09/21/2000|APPR|The device is used as an aid 1)in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (TCC) of the bladder (cut-off >= 7.5U/ml) in conjunction with and not in lieu of current standard diagnostic procedures and 2) in the management of patients with transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring TCC (cut-off >10U/ml).
N50510|S096|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/1999|12/10/1999|||APPR|Approval for the addition of the antibiotic piperacillin at concentrations of 4, 16 and 64ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System.  The device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to piperacillin in the range of <4 to >128ug/ml.
P960043|S020|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||TECHSTAR XL 6 FR. PERCUTANEOUS VASCULAR SURGICAL DEVICES||CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/1999|09/16/1999|||APPR|Approval for modifications to the manufacture and quality control of the Techstar(R) XL PVS System.
P980016|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||GEM II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDS||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/1999|12/11/2000|||APPR|APPROVAL FOR LABELING CHANGES OF THE MEDTRONIC MODELS 7221, 7223, 7227, 7229, 7271 AND 7273.
P900061|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM MODEL 7227/MICROJEWEL MODELS 7221, 7223 ICDS|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/1999|12/11/2000|||APPR|APPROVAL FOR LABELING CHANGES OF THE MEDTRONIC MODELS 7221, 7223, 7227, 7229, 7271 AND 7273.
N17987|S026|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/1999|08/30/1999|||APPR|Approval to transfer manufacturing of the CSI lens to the manufacturing site located at Wesley Jessen, Inc., Route 173, El Jibaro Industrial Park, Cidra, Puerto Rico.
P980001|S011|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR W/SOX PREMOUNTED STENT SYSTEM||CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/1999|03/16/2000|||APPR|Approval for the NIR (TM) w/SOX(TM) Premounted Stent System.
N50510|S097|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/1999|12/03/1999|||APPR|Approval for the addtion of the antibiotic ampicillin/sulbactam at concentrations of 4/2, 16/8, 32/16ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System.  The device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to ampicillin/sulbactam in the range of <2/1 to >32/16ug/ml.
N50510|S098|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR LEVOFLOXACIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/1999|11/05/1999|||APPR|Approval for the addition of the antibiotic levofloxacin at concentrations of 0.5, and 8ug/ml to the Vitek(R) 2 Gram Negative Susceptibility Test System.  The device is indicated for use in Vitek(R) 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to levofloxacin in the range of <0.25 to >8ug/ml.
N16837|S003|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT BOVINE HETEROGRAFT|LXA|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/1999|02/11/2000|||APPR|Approval of a manufacturing site located at Artegraft, Inc., North Brunswick NJ.
P890023|S008|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|BIOMEDICS 55 (OCUFILCON D) UV BLOCKER IMT SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/1999|08/13/1999|||OK30|The 30-Day Notice requested a UV blocker process change at Ocular Sciences' Santa Isabel facility.
P960054|S002|DEPUY, A JOHNSON & JOHNSON CO.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, constrained, cemented or uncemented, metal/polymer|S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER|KWZ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/1999|12/07/1999|||APPR|Approval for a design modification made to the S-ROM constrained liner so to be used withthe DePuy Duraloc and Solution Acetabular Cup Systems.  This device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
P880091|S017|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIC UVA PC IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/1999|09/02/1999|||OK30|The 30-Day Notice requested that STAAR Surgical Company be permitted to implement a Gentinge Castle Autoclave to sterilize products during the scheduled or unscheduled shutdown of the primary autoclave manufactured by Kuhlman Technologies, Inc.
N50510|S099|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/1999|11/15/1999|||APPR|Approval for the addition of the antibiotic benzylpenicillin at concentrations of 0.125, 0.25, 1, 2, 8 and 64ug/ml to the Vitek(R) 2 Gram Positive Susceptibility Test System.  The device is indicated for use in Vitek(R) 2 Gram Positive Susceptibility test Cards for the susceptibility testing of gram positive organism to benzylpenicillin in the range of <0.03 to >64ug/ml.
P950005|S006|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELLSIUS INTERFACE CABLES (AUTOCLAVABLE)|DRF|CV|||N|08/02/1999|02/01/2000|||APPR|
P970015|S005|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||INTER FIX RP THREADED FUSION DEVICE||OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/02/1999|04/12/2000|N||APPR|Approval for the INTER FIX RP Threaded Fusion Device
P960011|S003|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON 1% SODIUM HYALURONATE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/1999|09/02/1999|||OK30|The 30-Day Notice requested a manufacturing process change for BioLon(TM) (1% sodium hyaluronate).  The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade.
P860019|S156|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAXXUM PTCA CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/03/1999|02/01/2000|||APPR|Additional approval for the MAXXUM PTCA Catheter (balloon diamters ranging from 2.5-4.0 mm), the post-delivery expansion of balloon expandable stents.
P950034|S012|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/1999|08/27/1999|||OK30|The 30-Day Notice requested a manufacturing process change for Seprafilm(R) Bioresorbable Membrane.  The requested change would allow the use of LabelMax software and high speed laser printers to print the entire Seprafilm(R) Pouch Front Label and a new 10 Pack Box/Envelop Carton Label.
N50510|S101|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) 2 GRAM POSITIVE AST FOR ERYTHROMYCIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1999|12/10/1999|||APPR|Approval for the addition of the antibiotic erythromycin at concentrations of 0.25, 0.5, and 2ug/ml to the Vitek(R) 2 Gram Positive Susceptibility Test System.  The device is indicated for use in Vitek(R) 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive isolates to erythromycin in the range of <0.25 to >8ug/ml.
N50510|S102|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR CIPROFLOXACIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/1999|12/10/1999|||APPR|Approval for the addition of the antibiotic ciprofloxacin at concentrations of 1, 2 and 4 ug/ml to the Vitek(R) 2 Gram Positive Susceptibility Test System.  The device is indicated for use in Vitek(R) 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive organism to ciprofloxacin in the range of <0.5 to >8ug/ml.
P970033|S002|MIRABEL MEDICAL SYSTEMS, INC.|9020-1 CAPITAL OF TEXAS HGWY|SUITE 390|AUSTIN|TX|78759||Imager, breast, electrical impedance|TRANSCAN T-SCAN 2000|NCL|RA|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/15/1999|05/03/2000|||APPR|Approval of a protocol for a postapproval study to examine the effects of the mentrual cycle on the results of the device.
P950034|S013|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/1999|09/03/1999|||OK30|The 30-Day Notice requested a manufacturing process change for Seprafilm(R) Bioresorbable Membrane.  The requested change would allow the use of a new Urania Heat Sealer, Model 3500-P, to seal the foil pouches containing Seprafilm(R).
P960054|S003|DEPUY, A JOHNSON & JOHNSON CO.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, constrained, cemented or uncemented, metal/polymer|S-ROM POLY-DAIL CONSTRAINED LINER|KWZ|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/1999|12/22/1999|||APPR|Approva for the cleaning and packaging site located at DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork. Ireland and the sterilization facility located at ISOTRON plc, Marcus Close, Tilehurst, Reading, Berkshire FG30 4EA, England.
N50510|S103|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 ADVANCED EXPERT SYSTEM SOFTWARE|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/1999|11/10/1999|||APPR|Approval for the Vitek(R) 2 Advanced Expert System as an optional software accessory for the Vitek(R) 2 Susceptibility Test System.
P920015|S016|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT FAMILY OF TRANSVENOUS DEFIBRILLATION LEADS|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/12/1999|09/24/1999|||APPR|Approval for adding a caution label to the Medtronic(R) Sprint(TM) Lead Models 6932, 6937, 6942, 6943 and 6945.
P970051|S007|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NECLEUS 24 COCHLEAR IMPLANT SYSTEM SOFTWARE|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|08/13/1999|08/20/1999|||APPR|Approval for a software modification, the WinDPS Service Release 3.
P820076|S022|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|GEMNOS & DROMOS SL PULSE GENERATORS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/1999|08/24/1999|||APPR|Approval for 1) Non-Invasive Programmed Stimulation (NIPS) feature to be unlocked; 2) Automatic Sensor Gain (ASG) feature to be allowed in Actros+ family; 3) Release of programmer software version B-H02.0.U; 4) Change of trade name of PMS 1000C programmer to EPR 1000PLUS;  and 5) Use of the B-H02.0.U PCMIA software cartridge with the TMS1000 Tachyarrhythmia Monitoring system (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS.
P850059|S022|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|PMMA ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|08/16/1999|05/08/2001|||APPR|APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.
P870013|S014|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|PMMA ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|08/16/1999|05/08/2001|||APPR|APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.
P790027|S065|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|08/16/1999|05/08/2001|||APPR|APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMAA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMAA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.
P970031|S008|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/1999|02/23/2000|||APPR|A pre-trimmed subcoronary configuration, Model 995CS.
P920023|S009|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESES|MES|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/1999|09/17/1999|||APPR|Approval for a new manufacturing site located at American Medical Systems, 10700 Bren Road West, Minnetonka, MN.
P960007|S011|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE|MGR|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/1999|11/26/1999|||APPR|Approval for changing the frequency of the in-process sterility testing conducted on the device.
P970043|S004|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADAR VISION TREATMENTS|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/1999|09/24/1999|||APPR|Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use.  These indications for use remain:  PRK for the reduction or elimination of -1.00 to -10.00 D of spherical myopia with or without -1.00 to -4.00 D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50 and -10.00 D SE at the spectacle plane where sphere or cylinder magnitude is at least 1.00 D.
N50510|S104|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/20/1999|01/06/2000|||APPR|Approval for the addition of the antibiotic gentamicin at concentrations of 4, 16, and 32 ug/ml to the Viteck 2 Gram Negative Susceptibility Test System.  The device, as modified, will be marketed under the trade name Vitek 2 and is indicated for use in Vitek 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to gentamicin in the range of <=1 to >=16 ug/ml.
N50510|S106|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/20/1999|01/10/2000|||APPR|Approval for the addition of the antibiotic levofloxacin at concentrations of 0.25, 2 and 8ug/ml to the Vitek 2 Gram Positive Susceptibility Test System.  The device, as modified, will be marketed under the trade name Vitek 2 and is indicated for use in Vitek 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive organism to levofloxacin in the range of <=.125 to >= 8ug/ml.
P850049|S007|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER|DTK|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/20/1999|09/14/1999|||APPR|Approval to add a Patient Guide booklet to each device shipment.
P840008|S069|Dornier MedTech America, Inc.|1155 ROBERTS BLVD.||KENNESAW|GA|30144||Lithotriptor, extracorporeal shock-wave,urological|DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/20/1999|09/02/1999|||APRL|Approval for a change that would allow the option of a rotating x-ray anode in addition to the currently available stationary anode.
P930038|S021|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/1999|09/10/1999|||OK30|The 30-Day Notice requested a change from 10 weeks to 24 weeks as the maximum duration time between the molding date of the anchor and the sterilization date of the finished device that includes the anchor.
P960040|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM DR/VR AICD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1999|01/21/2000|||APPR|Approval is for modifications to VENTAK DR/VR AICD.  The device, as modified, will be marketed under the tradename VENTAK PRIZM DR/VR AICD System, Models 1850, 1851, 1855 and 1856 with Model 2844 Software, Version 1.1 and the indications remains the same as in the original PMA.
P910023|S044|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED-THERAPYDEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Express GMP Supplement|N|08/23/1999|10/13/1999|||APPR|Approval for an alternate manufacturing site for accessories and the DP-3238 Defibrillation Patch Lead located at St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577.
P950029|S006|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|TALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/1999|05/18/2000|||APPR|Approval for the introduction of Talent Rate Responsive Pacemaker Models DR213, DR223, and SR113; the Optus G Rate Responsive Pacemaker Models 4621 and 4624; and the CSO 4.12 Programming Software.
P970035|S017|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S660TM WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/1999|05/09/2000|||APPR|Approval for the Medtronic AVE (AVE) S660 with Discrete Technology Over-the-Wire and Rapid Exchange Coronary Stent Systems.
P900070|S025|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||implantable pacemaker Pulse-generator|R5.111WE(REVISION OF R5.85WE)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/1999|09/24/1999|||APPR|Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.
P880038|S035|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|NETWORK PROGRAMMER|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/1999|09/24/1999|||APPR|Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.
P820018|S073|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|NETWORK PROGRAMMER|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/1999|09/24/1999|||APPR|Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.
P880086|S068|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|CARDIAC PACEMAKER PROGRAMMER & BASE STATION|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/1999|09/24/1999|||APPR|Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSu Programmer.
P830045|S067|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|CARDIAC PACEMAKER PROGRAMMER & BASE STATION|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/1999|09/24/1999|||APPR|Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSU Programmer.
P880006|S030|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SOFTWARE MODEL 3264 REV A|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/1999|09/24/1999|||APPR|Approval for the Model 3264 rev A programmer software for use with the  Model 3250 APSu Programmer.
N50510|S107|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/1999|01/21/2000|||APPR|Approval for the addition of the antibiotic nitrofurantoin at concentrations of 16, 32, and 64 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.  The device, as modified, will be marketed under the tradename Vitek 2 and is indicated for use in Vitek 2 Gram Negative Susceptibility Test Card for the susceptibility testing of gram negative isolates to nitrofurantoin in the range of <= 16 to >= 512ug/ml.
P830060|S045|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|STYLET ACCESSORY KIT|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/1999|01/19/2000|||APPR|Supplemental approval is for the stylet accessory kit Models 6983 and 6985.
N50510|S108|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/1999|01/24/2000|||APPR|
N50510|S110|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/1999|01/31/2000|||APPR|Approval is for the addition of the antibiotic norfloxacin at concentrations of 0.5, 1 and 4ug/ml to the Vitek 2 Gram Positive Susceptibility Test System.  The device, as modified, will be marketed under the trade name Vitek 2 and is indicated for use in Vitek 2 Gram Positive Susceptibility Cards for the susceptibility testing of gram  positive organism to norfloxacin in the range of <= 0.25 to >=16ug/ml.
P950029|S007|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|BRIO CARDIAC PACEMAKERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/26/1999|09/16/1999|||APPR|Approval for the introduction of version 5 of the Brio pacemakers, including the introudction ofthe dedicated bipolar Model 222.
P970004|S005|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/1999|09/03/1999|||APPR|Approval for an alternate insulation material for the Medtronic(R) Model 3057 Temporary Test Stimulation Lead.
P970038|S004|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/1999|02/24/2000|||APPR|Supplemental approval for the addition of the Access Hybritech free PSA assay on the Access Immunoassay analyzer to the other approved instrument platforms.
N50510|S111|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR GENTAMICIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/30/1999|01/31/2000|||APPR|
N50510|S112|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR TICARCILLIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/30/1999|02/01/2000|||APPR|the additioin of the antibiotic ticarcillin at concentrations of 16, 32, and 64mg/ml to the Vitek 2 Gram Negative Susceptibility Test System
N50510|S113|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN|LTW|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/30/1999|02/08/2000|||APPR|The addition of the antibiotic streptomycin at a concentration of 1000mg/ml to the Vitek 2 Gram Positive Susceptibility Test System.
P910023|S045|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/1999|09/27/1999|||APPR|Approval to implement a minor manufacturing change (increase in the number of Kapton layers between the high voltage capacitors) in the Contour and Angstrom implantable defibrillators.
P830055|S064|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LSC REVISION SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/30/1999|10/04/1999|||APPR|Approval for a line extension consisting of the addition of LCS Revision System components include LCS cemented revision femoral, tibial tray, and augment components.  The stems of the LCS revision tibial tray and femoral components are designed to allow for the use of ancillary stem extensions and sleeves from cleared and currently marketed devices.  The device is indicated for the cemented revision of failed knee prostheses.
P970031|S009|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Express GMP Supplement|N|08/30/1999|09/29/1999|||APPR|Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
P790018|S035|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVE, AORTIC VALVED CONDUIT, AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT|LWQ|CV|Normal 180 Day Track|Express GMP Supplement|N|08/31/1999|09/29/1999|||APPR|Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
P870078|S005|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK 1 STANDARD BIOPROSTHETIC VALVE|DYE|CV|Normal 180 Day Track|Express GMP Supplement|N|08/31/1999|09/29/1999|||APPR|Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
P790007|S016|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES|LWR|CV|Normal 180 Day Track|Express GMP Supplement|N|08/31/1999|09/29/1999|||APPR|Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
P960004|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THIN LINE AND FINELINE PACING LEADS|DTB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/1999|10/21/1999|||APPR|Approval for a manufacturing process change.
P960004|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE/FINELINE|DTB|CV|Normal 180 Day Track|Express GMP Supplement|N|08/31/1999|09/27/1999|||APPR|Approval for the alternate manufacturing facility located at Guidant Puerto Rico, No. 12 Road No. 698, Dorado, Puerto Rico 00646 and the alternate sterilization facility located at COSMED of Illinois, 1160 Northpoint Blvd., Waukegan, Illinois 60085.
P930031|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT(R) TIPS ENDOPROSTHESIS AND UNISTEP(TM) PLUS DELIVERY SYSTEM|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1999|05/04/2000|||APPR|Approval for adding a reduced profile Unistep Plus delivery system for 10 mm diameter stents.
P940019|S005|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ILIAC ENDOPROSTHESIS|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/1999|05/05/2000|||APPR|Approval for a reduced profile delivery system.
N17987|S027|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CSI (CROFILCON A) EXTENDED WEAR SOFT|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|09/01/1999|11/18/1999|||APPR|Approval for a manufacturing site transfer of the CTL process for the CSI(TM) Lens from San Diego, CA to Wesley Jessen, Inc., Route 173, Kilometer 1.1, El Jibaro Industrial Park, P.O. Box 1980, Cidra, Puerto Rico 00739.
P980006|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/1999|11/23/1999|||APPR|Approval for: 1) adding a contraindication for the use of Allergan Ultracare disinfecting System to the product labeling (package insert/fitting guide and patient information booklet for frequent replacement wear); 2) removing references to thermal disinfection in the product labeling (package insert and patient information booklets); and 3) adding "The BAUSCH & LOMB(R) PureVision(TM) (balafilcon A) Visibility Tinted Contact Lenses are manufactured by a cast-molding process and are surface treated by the Performa(TM) surface treatment process which transforms hydrophobic silicone to hydrophilic silicate" to the Description section of the package insert/fitting guide.
P960007|S013|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE|MGR|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/02/1999|03/16/2000|||APPR|Approval to extend the expiration date to 20 months and to revise product labeling to indicate that the device may be stored by the end user at temperatures between -70C and -20C.
P910056|S007|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL LI63U|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/1999|12/16/1999|||APPR|Approvalfor Model LI63U and to use MED-6812SH silicone material as an alternative to RMX-3 silicone for models with polyimide haptics approved under this PMA.
P830055|S065|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/02/1999|10/07/1999|||APPR|Approval for a modification to the LCS Polyethylene Three-Pegged Patellar Component of the LCS Total Knee System.  The current modification reduces the thickness of the three-pegged polyethylene patellar components by approximately two millimeters.
P950032|S014|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF(R) (GRAFTSKIN)|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/02/1999|10/14/1999|||APPR|Approval to introduce a new cell strain into the production of Apligraf (i.e., HEP 601).
P950032|S015|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF(R)(GRAFTSKIN)|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/1999|09/28/1999|||OK30|The 30-day Notice requested a manufacturing process change.  The requested change will place into the manufacturing process the final 3 production-scale incubators manufactured by Lunaire Corporation (model #CI0641W-6SPL).
P970043|S005|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/03/1999|05/09/2000|00M-1593|11/14/2000|APPR|Approval for the LADARVision Excimer Laser System indicated for laser in-situ keratomileusis (LASIK).
P800068|S002|INSTRUMENTATION INDUSTRIES, INC.|1211 STREETS RUN RD.||PITTSBURG|PA|15236||Changer, tube, endotracheal|ENDOTRACHEAL TUBE CHANGERS|LNZ|AN|Normal 180 Day Track|Express GMP Supplement|N|09/03/1999|11/04/1999|||APPR|Approval for a manufacturing site located at FBK Medical Tubing, Inc., 511 Cobb St., Birmingham, AL  35209.
P830026|S075|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX5000 PROGRAMMER|LWP|CV|Normal 180 Day Track|Express GMP Supplement|N|09/07/1999|09/24/1999|||APPR|Approval for a manufacturing site located at Benchmark Electronics, 4065 Theurer Blvd., Winona, MN  55987.
P900052|S008|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM|LNY|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/1999|09/23/1999|||OK30|The 30-day Notice requested a manufacturing process change for the Port-A-Cath(R) Epidural Implantable Access System and for the Port-A-Cath(R)II Epidural Low Profile(TM) Implantable Access System.  This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the LAL-5000 System with PYROS Software.
P860003|S033|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVADEX(R) STERILE LIQUID|LNR|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/1999|03/06/2000|||APPR|Approval for a labeling change to reflect the use of UVADEX, the sterile liqud formulation of 8-methoxypsoralen.
P970058|S005|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER M1000|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/1999|10/05/1999|||APPR|Approval for the addition of the Canon Model 300 digitizer as an optional digitizer for the ImageChecker M1000.
P910058|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES WITH PLATE HAPTICS|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|09/09/1999|05/09/2001|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA.
P850064|S016|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/10/1999|10/05/1999|||APPR|Approval for the addition of three warnings.
P960013|S007|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL SDX|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/1999|03/07/2000|||APPR|Approval for the Tendril SDX Model 1488/K/TC endocardial, steroid-eluting, active-fixation pacing leads.
P890043|S034|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|SIMPSON CORONARY ATHEROCATH-GTO|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/1999|10/12/1999|||OK30|The 30-Day Notice requested implementation of two additional on-line inspections to the current manufacturing process to provide added assurance that the manufacturing step for attaching the nose cone to the housing has been performed correctly.
N50510|S114|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE NORFLOXACIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/1999|02/07/2000|||APPR|The addition of the antibiotic norfloxacin at concentrations of 1, 8, and 32ug/ml to the Vitek 2 gram Negative Susceptibility Test System.
N50510|S115|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE TETRACYCLINE|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/1999|02/08/2000|||APPR|Additioin of the antibiotic tetracycline at concentrations of 2,4,and 8mg/ml to the Vitek 2 Gram Negative Susceptibility Test System
P980015|S003|INNOVATIVE MEDICAL SYSTEMS, INC.|3610 OAKDALE DRIVE||MOUNTAIN BROOK|AL|35223||Device, needle destruction|SHARP(X)TM NEEDLE DESTRUCTION UNIT|MTV|HO|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/14/1999|09/17/1999|||APPR|Approval for a modification of a contraindication statement in the labeling.
P980022|S001|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325|||MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM||CH|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|09/15/1999|08/09/2000|||APPR|APPROVAL FOR THE POSTAPPROVAL STUDY PROTOCOLS.
N50510|S116|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) GRAM POSITIVE AST FOR NITROFURANTOIN|LTW|MI|Normal 180 Day Track||N|09/15/1999|02/08/2000|||APPR|The addition of the antibiotic nitrofurantoin at concentration fo 16,32 and 64 mg/ml to the Vitek 2 Gram Positive Susceptibility Test System.
P850029|S002|Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK,|IL|60064|3537|KIT, ASSAY, ESTROGEN RECEPTOR|ER-EIA MONOCLONAL|LPJ|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/1999|09/22/1999|||APPR|Approval for adding "Caution:  This Product Contains Natural Dry Rubber" to labeling.
P900013|S002|Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK,|IL|60064|3537|KIT, ASSAY, PROGESTERONE RECEPTOR|PGR-EIA MONOCLONAL|LPI|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/1999|09/22/1999|||APPR|Approval for adding "Caution:  This Product Contains Natural Dry Rubber" to the labeling.
P950029|S008|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/16/1999|12/03/1999|||APPR|Approval for the Multi-Partition Operating Environment to be used on ELA Medical programmers.
P970007|S001|Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK|IL|60064||ENZYME IMMUNOASSAY, TRACROLIMUS|ABBOTT IMX TACROLIMUS II|MLM|TX|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/1999|09/22/1999|||APPR|Approval for adding "Caution:  This Product Contains Natural Dry Rubber" to the labeling.
P900056|S029|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/1999|10/15/1999|||APPR|Approval for labeling changes to the Instructions for Use for the Rotablator System.
P890023|S009|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|BIOMEDICS 55 (OCUFILCON D) HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|09/17/1999|12/14/1999|||APPR|Approval for a new manufacturing facility located at Ocular Sciences/American Hydron, Juana Diaz Industrial Park, 500 Road 531, Juana Diaz, Puerto Rico.
P780007|S042|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|BIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|09/17/1999|12/14/1999|||APPR|Approval for a new manufacturing facility located at Ocular Sciences/American Hydron, Juana Diaz Industrial Park, 500 Road 531, Juana Diaz, Puerto Rico.
P830055|S066|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS POSTERIOR STABILIZED TIBIAL INSERTS|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/20/1999|10/07/1999|||APPR|Approval for a design modification to the LCS PS (Posterior Stabilized) Tibial Inserts of the LCS Total Knee System.  The proposed modifications to the PS Tibial Inserts include a reduction in the height of the anterior lip and a change in the medial/lateral angle of the tibial spine.
P980001|S012|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEMS||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/20/1999|03/20/2000|||APPR|Approval for a modification to the Indications for Use statement and the Instructions for Use (IFU) to include the results of the nine-month follow-up of the NIRVANA clinical trial for the NIR ON Ranger and NIR Primo Premounted Stent Systems.
P970051|S008|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS N24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/1999|07/11/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GRIFFITH ANALYTICAL, BURR RIDGE, ILLINOIS.
P790027|S066|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV-ABSORBING PMMA POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|09/21/1999|05/08/2001|||APPR|APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.
P810031|S022|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON(R) SODIUM HYALURONATE|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/1999|12/21/1999|||APPR|Approval for a modification to the final product release testing requirements for the family of Healon(R) Sodium Hyaluronate viscoelastic products.
P900066|S003|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY|LPO|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/1999|03/16/2000|||APPR|1)Change in manufacturing site; 2)Alternate synthesis route for perfluoropropane; and 3) Changing release specification for the perfluoropropane gas.
P940010|S008|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC|MVG|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/1999|07/07/2000|||APPR|APPROVAL FOR THE ADDITION OF SURGICAL TECHNOLOGIES, INC. AS AN ALTERNATE PACKAGING AND STERILIZATION SITE, AND MODIFICATIONS TO THE FIBER OPTIC REEL AND PRIMARY PACKAGING BOX.
P810002|S050|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VAVLE|LWQ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/1999|02/28/2000|||APPR|Describes a validation for the sterilization change.
P890025|S012|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD|MGU|TX|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/23/1999|09/29/1999|||APPR|Approval for adding "Caution:  This product contains natural dry rubber" to the labeling.
P950019|S010|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY THREADED FUSION CAGE(TFC)|MAX|OR|Normal 180 Day Track|Express GMP Supplement|N|09/27/1999|12/01/1999|||APPR|Approval for the Sulzer Spine-Tech facility located at 8990 Springbrook Drive, #10, Minneapolis, Minnesota 55433 as an alternate site for assembly, packaging and quality control of the device and the BioTest Laboratories, Inc., located at 7375 Bush Lake Rd., Minneapolis, Minnesota 55439 as an alternate site for assembly, packaging and labeling of the device.
P870013|S015|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|UV-ABSORBING ONE-PIECE PMMA ANTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|09/21/1999|05/08/2001|||APPR|APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.
P850059|S023|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|UV-ABSORBING PMMA ANTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|09/21/1999|05/08/2001|||APPR|APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.
P970043|S006|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADAR VISION EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/22/1999|01/07/2000|||APPR|Addition of the following statement to the warnings section: "A minimum of pre-operative pupillary dilation of 7mm and a maximum dilation of 11mm must be achieved and maintained in all patients throughout the refractive procedure to optimize tracker performance.
P850079|S032|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A SOFT HYDROPHILIC SPERICAL/TORIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/1999|11/24/1999|||APPR|Approval for adding disposable and frequent/planned replacement to the wearing schedule.
P910001|S017|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT|LPC|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/1999|03/17/2000|||APPR|The 135-day supplement requested approval for the addition of ethylene oxide sterilization equipment.
P960042|S005|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159||SPECTRANETICS LASER SHEATHS (SLS)||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/1999|03/17/2000|||APPR|The 135-day supplement requested apprroval for the addition of ethylene oxide sterilization equipment.
P960036|S001|IOLTECH, S.A.|64 SCHOOSETT STREET||PENBROKE|MA|02359|1882|intraocular lens|MEMORY LENS MODEL U940A UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL|HQL|OP|Real-Time Process|Other Report|N|08/23/1999|08/25/2000|||APPR|APPROVAL FOR A SHELF-LIFE EXTENSION TO 18 MONTHS, A PROPOSED PROTOCOL FOR ADDITIONAL SHEL-LIFE EXTENSIONS, AND A NEW DIMENSIONAL SPECIFICATION.
P920023|S010|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME(R) ENDOPROSTHESIS|MES|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/29/1999|02/14/2000|||APPR|Extend the shelf life expiration dating up to 5 years.
P940031|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/1999|10/22/1999|||APPR|Approval for addition of a non-conducting epoxy preform between layers of the "triple stack".
P960058|S011|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1999|11/18/1999|||APPR|Approval for the SCLIN 2000 Device Fitting Software for the CLARION(TM) Multi-Strategy Cochlear Implant (Pediatric).
P940022|S012|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1999|11/08/1999|||APPR|Approval for the SCLIN 2000 Device Fitting Software for the CLARION(R) Multi-Strategy Cochlear Implant (Adult).
P990017|S001|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE TUBE AND BIFURCATED SYSTEMS & ILIAC BALLOON CATHETER|MIH|CV|Normal 180 Day Track|Express GMP Supplement|N|09/30/1999|10/20/1999|||APPR|Approval for a new manufacturing facility located at Guidant Corporation, 1525 O'Brien Drive, Menlo Park, CA.
P960009|S007|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS|MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM|NHL|NE|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/1999|01/14/2002|02M-0217|05/13/2002|APPR|APPROVAL FOR THE MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY WHICH INCLUDES THE MODEL 3387 DBS LEAD, MODEL 3389 DBS LEAD, MODEL 7482 EXTENSION, MODEL 7495 EXTENSION, MODEL 7426 SOLETRA NEUROSTIMULATOR, BURR HOLE RING AND CAP, MODEL 7432 PHYSICIAN PROGRAMMER, MODEL 7460 MEMORYMOD SOFTWARE CARTRIDGE, MODEL 7452 PATIENT MAGNET, MODEL 3625 TEST STIMULATOR, MODEL 3353/3354 LEAD FRAME KIT, AND ACCESSORIES.  THE DEVICE IS INDICATED FOR BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPA-RESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.
P950009|S004|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|AUTOPAP PRIMARY SCREENING SYSTEM|MNM|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/1999|10/05/2001|||APPR|APPROVAL FOR USE OF THE DEVICE WITH AUTOCYTE PREP CERVICAL CYTOLOGY SLIDES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AUTOPAP PRIMARY SCREENING SYSTEM AND IS INDICATED FOR:  THE AUTOPAP PRIMARY SCREENING SYSTEM IS AN AUTOMATED CERVICAL CYTOLOGY SCREENING DEVICE INTENDED FOR USE IN INITIAL SCREENING OF CERVICAL CYTOLOGY SLIDES. THE AUTOPAP PRIMARY SCREENING SYSTEM IDENTIFIES UP TO 25% OF SUCCESSFULLY PROCESSED SLIDES AS REQUIRING NO FURTHER REVIEW.  THE AUTOPAP PRIMARY SCREENING SYSTEM ALSO IDENTIFIES AT LEASE 15% OF ALL SUCCESSFULLY PROCESSED SLIDES FOR A SECOND MANUAL REVIEW.  THE DEVICE IS INTENDED TO BE USED ON BOTH CONVENTIONALLY-PREPARED AND AUTOCYTE PREP CERVICAL CYTOLOGY SLIDES.  FOR BOTH PREPARATION METHODS, THE DEVICE IS INTENDED TO DETECT SLIDES WITH EVIDENCE OF SQUAMOUS CARCINOMA AND ADENOCARCINOMA AND THEIR USUAL PRECURSOR CONDITIONS; IT IS NOT INTENDED TO BE USED ON SLIDES DESIGNATED BY THE LABORATORY AS HIGH RISK.  INTENDED USERS ARE TRAINED CYTOLOGY LABORATORY PERSONNEL OPERATING UNDER THE DIRECT SUPERVISION OF A QUALIFIED CYTOLOGY SUPERVISOR OR LABORATORY MANAGER/DIRECTOR.
P880003|S079|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|RAPTOR PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/1999|04/27/2000|||APPR|Approval for the Raptor PTCA Catheter (balloon diameters ranging from 1.5 mm to 5.0 mm with lengths ranging from 10 mm to 35 mm).
P920004|S011|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL (VASCULAR HEMOSTASIS DEVICE)|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/1999|10/22/1999|||OK30|The 30-Day Notice proposed a change in the quality cotnrol tests used to delcare sterility of the VasoSeal(R) Needle Depth Indicator Kit.  The change will allow for dosimetric release following gamma radiation sterilization in accordance with ANSI/AAMI/ISO 11137-1995 Requirements for validation and routine control - Radiation sterilization.
P870056|S012|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/1999|10/22/1999|||OK30|The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves.  The change will allow for parametric release following terminal liquid sterilization in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process.
P870077|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS DURAFLEX BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/1999|10/22/1999|||OK30|The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves.  The change will allow for parametric release following terminal liquid sterilization in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process.
P860057|S012|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice||N|10/04/1999|10/22/1999|||OK30|The 30-Day Notice proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves.  The change will allow for parametric release following terminal liquid steriliztion in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process.
P990001|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON DIVA|DXY|CV|Normal 180 Day Track|Express GMP Supplement|N|10/05/1999|11/10/1999|||APPR|Approval for a manufacturing site located at Medtronic Swiss Manufacturing Facility, Medtronic S.A., Route du Molliau, 1131, Tolochenaz, Switzerland.
P960054|S004|DEPUY, A JOHNSON & JOHNSON CO.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, constrained, cemented or uncemented, metal/polymer|S-ROM POLY-DIAL CONSTRAINED LINER|KWZ|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/1999|11/10/1999|||APPR|Approval for a cleaning and packaging facility located at DePuy Orthopaedics, Inc., 700 Orthopaedic Drive, Warsaw, IN  46581.
P970015|S008|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||INTER FIX THREADED FUSION DEVICE||OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/1999|04/12/2000|N||APPR|Approval of the the 22mm and 24mm diameter Interfix Threaded Fusion Device.
P980001|S013|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/1999|11/04/1999|||OK30|The 30-Day Notice requested an alternate manufacturing method of attaching the core wire to the hypotube sub assembly on the NIR(TM) PRIMO(TM) Premounted Stent Delivery System.
P860019|S157|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/1999|11/03/1999|||OK30|The 30-Day Notice requested an alternate manufacturing method of attaching the proximal shaft to t he core wire sub-assembly on the following PTCA catheters:  Viva(TM) P860019/S143; Maxxum(TM) P860019/S144; NC Maxxum(TM) P860019/S150; Adante(TM) P860019/S154.
P840068|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA/VISTA PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/1999|11/05/1999|||APPR|Approval for modifications to the Programmer Software Model 2881 version 1.3 and its labeling, used with the Model 2950 and Model 2901 PRM Prorammers, to correct software anomalies and update features.
P910077|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DELTA/VISTA PACEMAKERS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/1999|11/05/1999|||APPR|Approval for modifications to the Programmer Software Model 2881 version 1.3 and its labeling, used with the model 2950 and 2901 PRM Programmers, to correct software anomalies and update features.
P880003|S080|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|NINJA FX PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/07/1999|07/07/2000|||APPR|APPROVAL FOR NINJA(FX) PTCA DILATATION CATHETER WITH THE FOLLOWING BALLOON SIZES: 1.5 MM X 20 MM, 25 MM, AND 30 MM; 2.0 MM X 20 MM, 25 MM, AND 30 MM; 2.25 MM - 4.0 MM (IN 1/4 MM SIZES) X 10 MM, 15 MM, 18MM, 20 MM, 25 MM, AND 30 MM; 4.5 MM X 20 MM; AND 5.0 MM X 20 MM.  THE NINJA(FX) PTCA DILATATINO CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P940031|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN PACEMAKER SYSTEMS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/04/1999|10/20/1999|||APPR|Approval for Software Application Model 2890 Revision 3.27 which removes automatic Minute Ventilation (MV) initialization, adds a "pop-up" warning ont he programmer screen prior to manual MV initialization, and corrects several minor anomalies applicable to the entire PDM pacemaker line.
P900023|S030|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1999|03/13/2000|||APPR|Approval for using model EWS300P-24 AC/DC Converter manufactured by Lambda, Melville, NY as an alternate AC/DC Converter in the BVS 5000 and BVS 5000i consoles.
P970015|S009|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||INTER FIX RP THREADED FUSION DEVICE||OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/1999|04/12/2000|||APPR|Approval for the 22 and 24 mm Diameter Inter Fix RP Threaded Fusion Device.
P830026|S076|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RX5000 PROGRAMMER|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/07/1999|10/29/1999|||APPR|Approval for a modification to the as shipped configuration for refurbished and repaired Rx5000 Pacemaker Programmers.  Specifically, to offer the Triangular Chest Lead Cable Model 526-04 as a purchasable accessory and no longer include it with the shipped units.
P810046|S199|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS OTW PHOTON CORONARY DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/1999|10/29/1999|||OK30|The 30-Day Notice requested: 1) modification of the manufacturing process by which the proximal adapter is bonded to the proximal portion of the ACS OTW PHOTON(TM) Coronary Dilatation Catheter; and 2) modification of the adaptation tensile test at the finished device audit process.
N50510|S117|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR OXACILLIN|LTW|MI|||N|09/27/1999|02/15/2000|||APPR|
N50510|S118|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR CEFOXITIN|LTW|MI|||N|09/30/1999|02/10/2000|||APPR|
N50510|S119|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN/TAZOBACTAM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/1999|02/17/2000|||APPR|The addition of the antibiotic piperacillin/tazobactam at concentrations of 4/4, 16/4, and 128/4ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.
N50510|S120|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR CEFPODOXIME|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/1999|02/01/2000|||APPR|The addition of the antibiotic cefpodoxime at concentrations fo 0.5, 1, 4mg/ml to the Vitek 2 Gram Negative Susceptibility Test System.
N50510|S121|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/1999|03/09/2000|||APPR|Approval for the addition of the antibiotic meropenem at concentrations of 0.5, 4, and 16 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.
P880003|S081|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|NC NINJA PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/1999|09/21/2000|||APPR|APPROVAL FOR THE NC RAPTOR PTCA CATHETER (BALLOON DIAMETERS RANGING FROM 2.25 MM TO 4.0 MM AND LENGTHS RANGING FROM 10 MM TO 30 MM).  THE NC RAPTOR PTCA CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  MODELS WITH THE FOLLOWING BALLOON SIZES (LENGTH X DIAMETER) ARE ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS: 2.25 MM X 10 MM TO 15 MM; 3.0 MM X 20 MM TO 30 MM; AND 4.0 MM X 15 MM TO 30 MM.
P890055|S011|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/1999|10/25/1999|||APPR|Approval for the following modifications: 1) Increasing the Flex Tip Plus Intraspinal Catheter length; 2) Combining the infusion pump and the approved refill kit to facilitate the pump pre-implant procedure; 3) Adding a thermometer to the packaging for the monitoring of water bath temperature; and 4) Adding an informational chart of drug solution to the labeling.
P990001|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON DIVA IMPLANTABLE PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/1999|11/12/1999|||APPR|Approval for modifications to the Diva family implantable pulse generator:  adding the following new models: Diamond II Model 820E; Ruby II Model 720E; Topaz II Model 520E; Jade II Model 220E; vita DDDr Model 810E; Vita DDD Model 710E; Vita VVIR Model 310E.  Introduction of 3.2mm models the Diamond II Model 822E and Topaz II Model 522E; modifying the programmer software to recognize the new model numbers; modifying the header to be consistent with the Medtronic Kappa 400; move to mulitple feedthroughs from a single feedthrough design; change the tissue contracting materials and packaging to those currently used in Medtronic's Kappa 400; and modify the labeling to accommoate the additional models and attendant software changes.
N50510|S122|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR CEFTIZOXIME|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/1999|03/20/2000|||APPR|Approval for the addition of the antibiotic ceftizoxime at concentrations of 2, 8, and 32ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.
P950029|S009|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/1999|11/19/1999|||APPR|Approval for the CSO 4.10 UG Programmer Software, for use with the ELA programmers.
N50510|S123|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/14/1999|03/20/2000|||APPR|Approval for the addition of the antibiotic nalidixic acid at concetrations of 8, 16, and 32ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.
N50510|S124|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/14/1999|03/20/2000|||APPR|Approval for the addition of the antibiotic amoxicillin/clavulanic acid at concentrations of 4/2, 16/8, and 32/16ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.
P880031|S013|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/15/1999|11/08/1999|||APPR|Approval to 1) extend the finished product UV absorbance specification from 0.012 AU to 0.016 AU and 2) eliminate the UV absorbance specification from the 24 month shelf-life.
P980049|S001|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140|||DEFENDER IV MODEL 612 DUAL-CHAMBER, RATE-RESPONSIVE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, ELA MEDICAL PROMGRAMMER||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/1999|05/18/2000|||APPR|Approval for Defender IV DR Model 612.
P860004|S043|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC MODEL 8711 TWO PIECE INTRATHECAL CATHETER|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|10/18/1999|10/29/1999|||APPR|Approval for a design change to the Model 8703W intraspinal catheter.  The resulting catheter incorporates the same materials and basic design as Model 8703W except for a closed distal tip with six side holes instead of a single open tip.  The device, as modified, will be marketed under the trade name Medtronic(R) Model 8711 Two Piece Intrathecal Catheter and is indicated for the containment and delivery of parenteral drugs to the intrathecal space of the spinal cord.
P830055|S067|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|10/18/1999|11/22/1999|||APPR|Approval for several sizes of newly developed trochlear groove implants to be used in conjunction with currently marketed patellar componenets of the LCS Total Knee System for the purpose of resurfacing the patellofemoral joint.  This device is indicated for patients with isolated patellofemoral osteoarthritis, a history of patellar dislocation or patellar fracture, or a failed previous surgery where pain, deformity or dysfunction persist.  The trochlear implants are intended for cemented use only.
P850048|S016|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ACCESS(R) HYBRITECH PSA ASSAY|LTJ|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/18/1999|02/24/2000|||APPR|Approval for addition of the Access Hybritech PSA Assay on the Access Immunoassay analyzer to other approved instrument platforms.
P900056|S030|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|10/20/1999|12/02/1999|||APPR|Approval for modifications to existing related quality assurance inspections, manufacturing changes, and labeling changes, which are being implemented to correct a brake mechanism failure problem.
P900056|S031|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/1999|12/02/1999|||APPR|Approval for manufacturing and design modifications, which are being implemented to correct a brake mechanism failure problem.
P890027|S048|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|ESPRIT22 SPEECH PROCESSOR|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/1999|12/23/1999|||APPR|Approval for the ESPrit 22 Speech Processor.
P840024|S079|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|ESPRIT22 SPEECH PROCESSOR|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/1999|12/23/1999|||APPR|Approval for the ESPrit 22 Speech Processor.
P960028|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRALOCULAR|MFK|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/1999|12/09/1999|||APPR|Approval for expansion of the diopter range from 10-30D to 6-30D.
P900023|S031|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/21/1999|04/14/2000|||APPR|Approval for the Abiomed BVS 5000t Bi-Ventricular Support System Transport/Backup Console.
P980009|S004|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT(R) SELF-EXPANDING CORONARY STENT|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/1999|11/29/1999|||APPR|Approval for a change to the package labeling and Instructions for approval for a change to the package labeling and Instructions for Use.
P950002|S008|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK/L INTERBODY FUSION SYSTEM|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/1999|12/20/1999|||APPR|Approval for the additional sizes to the BAK product line.
P830026|S077|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE PACEMAKER|LWP|CV|Normal 180 Day Track|Express GMP Supplement|N|10/25/1999|12/02/1999|||APPR|Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798.
P860007|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|IMPLANTABLE PACEMAKER LEADS|LWW|CV|Normal 180 Day Track|Express GMP Supplement|N|10/25/1999|12/02/1999|||APPR|Approval for the manufacturing and labeling facility located at Guidant    Corp., St. Paul, MN 55112-5798.
P910020|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|IMPLANTABLE PACEMAKER LEADS|DXY|CV|Normal 180 Day Track|Express GMP Supplement|N|10/25/1999|12/02/1999|||APPR|Approval for the manufacturing and labeling facility located at Guidant    Corp., St. Paul, MN 55112-5798.
P940008|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||IMPLANTABLE PACEMAKER LEAD||CV|Normal 180 Day Track|Express GMP Supplement|N|10/25/1999|12/02/1999|||APPR|Approval for the manufacturing and labeling facility located at Guidant    Corp., St. Paul, MN 55112-5798.
P960004|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|IMPLANTABLE PACEMAKER LEAD|DTB|CV|Normal 180 Day Track|Express GMP Supplement|N|10/25/1999|12/02/1999|||APPR|Approval for the manufacturing and labeling facility located at Guidant     Corp., St. Paul, MN 55112-5798.
N13787|S003|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|Solution, cleaning/lubricating, artifical eye|ENUCLENE(R) OPHTHALMIC SOLUTION|MSI|OP|Normal 180 Day Track|Express GMP Supplement|N|10/25/1999|12/10/1999|||APPR|Approval for the alternate manufacturing facility located at Alcon Laboratories, Inc., ASPEX Manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134.
N50510|S125|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1999|03/31/2000|||APPR|This device will be marketed as Vitek 2 which tests for the antibiotic ampicillin/sulbactam at concentrations of 4/2, 8/4, 16/8 and 64/32 micrograms per milliliter.
N50510|S126|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1999|03/31/2000|||APPR|This device will be marketed under the tradename Vitek 2 and adds the antibiotic cefazolin at concentrations 4,8,and 16 micrograms per millileter to the Vitek 2 Gram Positive Susceptibility Test System.
N50510|S127|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR AMPICILLIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/1999|04/05/2000|||APPR|Approval for the addition of the antibiotic ampicillin at concentrations of 4, 8, and 21 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System.
N16895|S086|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH AND LOMB POLYMACON CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/1999|11/02/1999|||OK30|The 30-Day Notice requested introduction of a manufacturing process change for the Polymacon Contact Lenses for extended wear.  The requested change will allow the lenses to be manufactured using an alternate polyvinyl chloride resin mold material.  The manufacturing process and procedures will not change.
N17987|S028|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CSI(CROFILCON A)EXTENDED WEAR SOFT|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|10/27/1999|09/18/2000|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.
P950039|S006|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 3000 PROCESSOR|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/1999|05/25/2000|||APPR|Approval for a second generation model of TP-2000 that has the capability of automatically preparing up to 80 cytology specimens.
P900009|S008|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 3000|LPQ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/1999|04/14/2000|||APPR|Approval for various design and manufacturing changes which do not affect the output of the device.  The device, as modified, will be marketed under the trade name Exogen 3000.
P970004|S006|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM CONTINENCE CONTROL SYSTEM|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/28/1999|11/04/1999|||APPR|Approval for a revised Implant Patient Manual that will be given to the patient prior to the implant surgery.
P960009|S008|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL THERAPY SYSTEM|MHY|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/1999|12/17/1999|||APPR|Approval for a manufacturing site located at Medtronic Puerto Rico, Villalba, Puerto Rico.  The percutaneous extension accessory device (Part #502644-TAB) will be manufactured at this facility.
P980035|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC 350 SERIES PACING SYSTEM||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/11/1999|12/09/1999|||APPR|Approval for the Medtronic Model 350 Series Pacing System Programmed by the Medtronic Model 9790/C Programmer with Sigma Model 9963/9963A software.
P900043|S018|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|CROSSFLEX LC BALLOON EXPANDABLE STENT WITH OTW DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|11/01/1999|02/25/2000|||APPR|Approval of 5-year post approval study.
P950014|S019|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON PRAKTIS|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/1999|11/05/1999|||APPR|Approval for 1) disabling the hardware that controls the minimum coolant temperature, and 2) modifying the maximum microwave power rating on the faceplate label.
P990017|S002|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112|||ANCURE TUBE AND BIFURCATED ENDOVASCULAR SYSTEMS||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/1999|01/13/2000|||APPR|Approval for manufacturing changes.
P980037|S001|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|N|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1999|04/03/2000|||APPR|Approval for the model TF140 Catheter, a modification to the currently apprved LF140 catheter.
P980035|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC KAPPA 400/DX2 AND KAPPA 700/600 PACEMAKERS||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/1999|12/23/1999|||APPR|Approval for the Medtronic Vision software Model 9952/9952A series 3.0 (to program the Medtronic Kappa 400/DX2 devices) and the Medtronic Vision software Model 9953/9953A series 3.0 (to program the Medtronic Kappa 700/600 devices).  The devices are indicated for use with the Medtronic Model 9790 and Model 9790C Programmers for the interrogation and programming of implantable pulse generators via radiofrequency telemetry.
P980031|S001|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)|LQE|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/1999|11/29/1999|||OK30|The 30-day Notice requested the implementation of the View Engineering voyage Model V1212 Dimensional Non-contact Measurement system for the inspection of thickness, width and symmetry of the Intacs(TM) (Intrastromal Corneal Ring Segements).
P980023|S003|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|DTA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/1999|05/01/2000|||APPR|Approval for: 1) the introduction of Patient data Manager Softward, PDM 2000, and 2) a new method for determining the Use Before Date of Biotronik's ICDs.
P980016|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MODEL 7271 GEM DR ICD||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/1999|12/23/1999|||APPR|Approval for low power hybrid circuitry changes which will improve the patient alert drive transistors, the charge pump circuit and the manufacturing process.
P980016|S011|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC MODEL 7271 GEM DR ICD||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/1999|06/15/2000|||APPR|APPROVAL FOR MODIFICATIONS TO THE CIRCUITRY OF THE MEDTRONIC(R) MODEL 7271 GEM(TM) DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR.
P920047|S013|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134|||EPT-1000 CARDIAC ABLATION SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/1999|11/30/1999|||OK30|The 30-Day Notice requested a change in the manufacturing (sterilization) process for therapeutic ablation catheters used with the EPT-1000 that will allow the use of alternate biological indicators with a reduced incubation time.
P860003|S034|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/1999|11/29/1999|||OK30|The 30-Day Notice requested a change in the sterilization process to place the biological indicator, that is normally placed inside of the treatment kit packaging, in an external challenge device on the outside of the kits.
P900033|S003|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||Dressing, wound and burn, interactive|INTEGRA  ARTIFICIAL SKIN|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1999|11/23/1999|||OK30|The 30-Day Notice requested a change to the Quality Control test used to determine the chondroitin-6-sulfate content in INTEGRA(R) Artificial Skin, Dermal Regeneration Template.
P990033|S001|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN-P15|NPZ|DE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/1999|01/27/2000|||APPR|Approval is for a new sterilization facility located at STERIS-Isomedix Services, 9120 South 150 East, Sandy, Utah.
P980016|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||GEM II IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR MODELS 7273 & 7229||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/08/1999|12/13/1999|||APPR|Approval for modifications to the circuitry of the Medtronic(R) Models 7273 and 7229 Implantable Cardioverter Defibrillators.
P860019|S158|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/1999|02/23/2000|||APPR|Alternative catheter packaging configuration.
P960058|S012|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355|||CLARION MULTI-STRATEGY COCHLEAR IMPLANT SYSTEM||EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1999|02/02/2000|||APPR|Size reduction in the speech processor known as the Platinum Sound Processor.
P940022|S013|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|PLATINUM SOUND PROCESSOR (COCHLEAR IMPLANT)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/1999|02/02/2000|||APPR|Size reduction in the speech processor known as the Platinum Sound Processor.
P990004|S001|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876|||SURGIFOAM ABSORBABLE GELATIN SPONGE, USP||SU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/15/1999|12/02/1999|||APPR|Approval for the addition of sponges 3mm and 7mm thick.
P950001|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE(R) PICOTIP(TM) STEROID-ELUTING ENDOCARDIAL ATRIAL-J LEADS|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/1999|05/10/2000|||APPR|Approval for the Atrial J SELUTE PICOTIP Steroid Eluting Pacing Lead, Models 4063 and 4064.
N16895|S087|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS (POLYMACON) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/16/1999|03/26/2001|||APPR|APPROVAL FOR  1) THE ESTABLISHMENT OF SEPARATE LABELING FOR THE THERAPEUTIC USE INDICATION; AND,  2) COMBINING THE PACKAGE INSERT AND PROFESSIONAL FITTING GUIDE INTO A SINGLE REFERENCE INTENDED FOR THE EYE CARE PRACTITIONER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SOFLENS(R) (POLYMACON) CONTACT LENSES (PLANO T) AND BAUSCH & LOMB OPTIMA(R) FW (POLYMACON) VISIBILITY TINTED CONTACT LENSES.  THE LENSES ARE INDICATED FOR USE IN THE TREATMENT AND MANAGEMENT OF ACUTE AND CHRONIC CORNEAL PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL ULCERS AND EROSION, DRY EYES, KERATITIS PROTECTION OF CORNEA DURING AND AFTER SURGERY, ACCIDENTAL OR SURGICAL TRAUMA, AND ENTROPION.  WHEN PRESCRIBED FOR THERAPEUTIC USE, THE SOFLENS(R) (POLYMACON) CONTACT LENSES (PLANO T AND OPTIMA(R) FW) MAY BE WORN FOR DAILY OR EXTENDED WEARING PERIODS.  THE EYE CARE PRACTITIONER SHOULD RECOMMEND EITHER SINGLE-USE DISPOSABLE WEAR OR A SCHEDULE OF PERIODIC REPLACEMENT, AND SHOULD PROVIDE INSTRUCTIONS FOR CLEANING, DISINFECTION, AND REPLACEMENT OF THE LENSES.  THE LENSES MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM.  THE LENS SHOULD BE INSERTED AND REMOVED ONLY AS THE EYE CARE PRACTITIONER HAS INSTRUCTED.
P990004|S002|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876|||SURGIFORM ABSORBABLE GELATION SPONGE, USP||SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/16/1999|02/08/2000|||APPR|A change in the "Indications for Use" statement.
P870015|S034|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|TRANSPORTABLE MODEL STS-T LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/1999|11/19/1999|||APRL|Approval for minor changes to the hardware (i.e., modification to the remote control, addition of a foot switch, increase in the travel distance of the shockwave positionere, and modification to the printed circuit board that interfaces the computer with the axis controllers) and software (i.e., upgrade to version 1999.3), as well as minor changes tot he device's labeling.
P900043|S019|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/1999|04/06/2000|||APPR|Approval of the addition of the abrupt and threatened closure indication for the Cross flex LC Balloon Expandable Stent with over-the-wire Delivery System.
P990020|S001|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/1999|12/10/1999|||OK30|The 30-Day Notice requested a change to add a supplier of expanded stents.
P890057|S013|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|ELECTROMECHANICAL ENHANCEMENT TO DRIVER|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/1999|04/11/2000|||APPR|Approval for a modified 3.0 ohms drivers coil assembly.
P960004|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE ENDOCARDIAL PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/1999|03/29/2000|||APPR|Approval for the use of Nusil MED 4870 as an alternate material for the suture sleeve and extension of the shelf life of your devices to 4 years.
P900056|S032|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/23/1999|01/28/2000|||APPR|Approval is for a labeling change to the console instructions for use.
P880027|S056|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/1999|01/07/2000|||APPR|Revisions to the box and pouch labels for the Bonnie PTCA catheter.
P970015|S010|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|LORDOTEC(TM) TAPERED FUSION DEVICE|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/1999|09/28/2000|||APPR|APPROVAL FOR A TAPERED VERSION OF THE INTERFIX(TM) THREADED FUSION DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LT-CAGE(TM) TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL.  LT-CAGE(TM) IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH.  PATIENTS RECEIVING THE LT-CAGE(TM) LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE LT-CAGE(TM)
P950015|S006|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|HEART LASER(TM) CO2 TMR SYSTEM|MNO|CV|Special (Immediate Track)||N|11/24/1999|01/11/2000|||APPR|SUPPLEMENTARY PRODUCT LABELING
P950005|S007|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER THERMOCOUPLE OR THERMISTOR|DRF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/26/1999|03/13/2000|N||APPR|Approval for a six-month shelf life.
P950014|S020|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/26/1999|04/13/2000|||APPR|Approval for changes to the Prostatron software program to include the 30-Minute TUMT treatment protocol.
P970043|S007|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)|LZS|OP|Panel Track|Change Design/Components/Specifications/Material|Y|09/03/1999|09/22/2000|00M-1612|11/21/2000|APPR|APPROVAL FOR THE LADARVISION(R) EXCIMER LASER SYSTEM.  THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATINO OF REFRACTIVE ERROR OF LESS THAN OR EQUAL TO +6.00D OF SPHERE AND -6.00D OF CYLINDER AT THE SPECTACLE PLANE (HYPEROPIA WITH OR WITHOUT ASTIGMATISM AND MIXED ASTIGMATISM); 1) IN SUBJECTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D FOR CORRECTIONS UP TO +6.00D SE; AND, 3) IN SUBJECTS WHO ARE 21 YEARS OF AGE OR OLDER.
P960043|S021|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIES||CV|Normal 180 Day Track|Express GMP Supplement|N|11/30/1999|03/02/2000|||APPR|Express supplement approval for an alternate sterilization facility located at Griffith Micro Science, Los Angeles, California.
P910073|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/11/2000|04/20/2000|||APPR|Approval for changes to the helix mechanism of the ENDOTAK ENDURANCE EZ Endocardial Defibrillation Lead.
P790002|S021|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM-MODEL 1026|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/1999|12/29/1999|||APPR|Seven modifications to the Model 1026.  Addition of components to the printed wiring board, addition of a ferrite sleeve, change in the control unit and labeling changes.
P990017|S003|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112|||EVT ABDOMINAL AORTIC TUBE/EVT ABDOMINAL AORTIC BIF||CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|11/01/1999|03/29/2000|||APPR|Approval for shelf life extension test protocol.
P920014|S010|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE IP AND VE LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/01/1999|12/10/1999|||APPR|Approval to introduce self-locking screw rings to attach the pump elbows to the two valved conduits and the outflow valved conduit to the outflow graft.
P950035|S005|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM|GZC|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/1999|01/13/2000|||APPR|1)Replace the MRI warning in the package insert,clinician manual and user manual with a precaution statement that provides information for performing MRI scanning of patients with the Freehand System; 2) modify the IDE card  to include wording advising NeuroControl be contacted for information prior to MRI scanning; 3) "MRI Information Sheet" which provides guidance for MRI scanning will be provided upon request.
P970003|S024|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/03/1999|12/18/1999|||APPR|Approval for labeling changes to enhance the safety of Model 400 NCP Tunneling Tool.
P970035|S018|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S540 OVER THE WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/1999|12/22/1999|||OK30|Manufacturing changes being made to the inner member necking process
P970012|S009|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC VISION SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/1999|12/23/1999|||APPR|Approval for the Medtronic Vision software Model 9952/9952A series 3.0 (to program the Medtronic Kappa 400/DX2 devices) and the Medtronic Vision software Model 9953/9953A series 3.0 (to program the Medtronic Kappa 700/600 devices).  The devices are indicated for use with the Medtronic Model 9790 and Model 9790C Programmers for the interrogation and programming of implantable pulse generators via radiofrequency telemetry.
P980035|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC.KAPPA 700/600 SERIES OF PACEMAKERS||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/06/1999|12/20/1999|||APPR|Approval for a correction to the shipping box label for the Model KDR 721 pacemaker properly identifying the contents as a "Dual Chamber Rate Responsive Pacemaker."
P970020|S019|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/1999|12/22/1999|||OK30|Addition of on-line inspection step for various lengths and diameters of the ACS Multi-Link DUET RX and OTW Coronary Stent Systems
P970029|S003|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|ECLIPSE TMR HOLMIUN LASER SYSTEM|MNO|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|12/06/1999|03/22/2000|||APPR|Approval of a new test fiber and four new labels.
P970030|S003|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST JUDE TORONTO SPV VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/1999|01/06/2000|||OK30|Six manufacturing process chemical solution changes used in the production of the St. Jude Medical Toronto SPV Valve.
P950022|S007|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|VENTRITEX SPL LEAD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/14/1999|01/20/2000|||APPR|Approval is for minor modifications to SPL Leads ( Models SP01, SP02, SP03, and SP04).
P990017|S004|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112|||ANCURE(TM) ENDOGRAFT(R) SYSTEM||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/14/1999|01/07/2000|||APPR|Approval for labeling changes under 21 CFR 814.39(d)
P960006|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET TIP RX STEROID ELUTING LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1999|03/10/2000|||APPR|Approval for the use of a modified suture sleeve.
P830060|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1999|03/10/2000|||APPR|Approval for the use of a modified suture sleeve.
P910077|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1999|03/10/2000|||APPR|Approval for the use of a modified suture sleeve.
P930038|S022|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1999|04/06/2000|||APPR|Approval for a modification to the 8F Angio-Seal device to include a  monofold design for the insertion sheath component.
P950001|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE(R) STEROID-ELUTING LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1999|03/10/2000|||APPR|Approval is for the use of a modified suture sleeve.
P910073|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/1999|03/10/2000|||APPR|Approval for the use of a modified suture sleeve.
P910065|S002|TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|AIA PACK PA|LTJ|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/16/1999|03/03/2000|||APPR|Approval for the addition of the AIA 600 II analyzer instrument to the list of approved analyzers using the AIA-Pack PA assay.
P970008|S013|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS(TM) SYSTEM|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/16/1999|06/05/2000|||APPR|APPROVAL FOR THE 28.5 MINUTE TREATMENT OPTION.
P900056|S033|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/17/1999|05/30/2000|||APPR|APPROVAL FOR A LABELING CHANGE TO CLARIFY THE APPARENT ABSENCE OF THE CATHETER CONNECTOR.
P970051|S009|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|SPRINT LONG RANGE COIL|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/1999|12/23/1999|||APPR|Approval for the SPrint Long Range Coil.
P900061|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/1999|03/02/2000|||APPR|Approval for modifications to the circuitry of the Medtronic Model 7227 GEM Implantable Cardioverter Defibrillator.
P940031|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 6698 PATIENT TEST MAGNET|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2000|02/25/2000|||APPR|Approval for the Model 6698 Patient Test Magnet.
P910077|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 2920 PRM SYSTEM ZOOM (VENTAK PRX AICD SYSTEM)|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1999|05/18/2000|||APPR|Approval for the Model 2920 ZOOM Programming System.
P960040|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 2920 (PRM) SYSTEM ZOOM (VENTAK AV AICD SYSTEM)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1999|05/18/2000|||APPR|Approval for the Model 2920 ZOOM Programming System.
P940031|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 2920 (PRM) SYSTEM ZOOM (VIGOR DR/SR PACEMAKER SYSTEM)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1999|05/18/2000|||APPR|Approval for the Model 2920 ZOOM Programming System.
P840068|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 2920 (PRM) SYSTEM ZOOM (DELTA PACEMAKER SYSTEM)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1999|05/18/2000|||APPR|Approval for the Model 2920 ZOOM Programming System.
P960034|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||POLYMETHYLMETHACRYLATE(PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES||NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/1999|02/07/2000|||APPR|
P970015|S011|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||INTER FIX III THREADED FUSION DEVICE||OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/1999|06/06/2000|||APPR|APPROVAL FOR ADDITION OF HOLES IN THE ENDCAPS OF THE INTER FIX(TM) THREADED FUSION DEVICE.
P950032|S016|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/23/1999|06/20/2000|00M-1508|09/11/2000|APPR|APPROVAL FOR USE WITH STANDARD DIABETIC FOOT ULCER CARE FOR THE TREATMENT OF FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS OF GREATER THAN THREE WEEKS DURATION WHICH HAVE NOT ADEQUATELY RESPONDED TO CONVENTIONAL ULCER THERAPY AND WHICH EXTEND THROUGH THE DERMIS BUT WITHOUT TENDON, MUSCLE, CAPSULE OR BONE EXPOSURE.
N17752|S037|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A)|LPL|OP|Normal 180 Day Track|Express GMP Supplement|N|12/23/1999|09/18/2000|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.
P980031|S002|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)|LQE|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/1999|01/12/2000|||OK30|The 30-day notice requested the implementation of a qualified sampling plan for dimensional inspection of the product attributes: width, arc length, outside diameter, symmetry and hole placement.
P850057|S006|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A)|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|12/23/1999|09/18/2000|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.
P970003|S025|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/1999|02/16/2000|||APPR|Changes to the approved patient labeling for the NCP system.
P900043|S020|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY(TM) STENT WITH RAPTOR OVER-THE WIRE DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/27/1999|05/11/2000|||APPR|Approval for a modified stent system.
P860003|S035|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHORESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/1999|01/14/2000|||APPR|Approval is for a new material, Codan Polypropylene RE764F/Cawiton, to be used in the body of the drip chamber of the UVAR XTS System's disposable set.
P900007|S002|Cook Incorporated|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||CATHETER, SAMPLING, CHORIONIC VILLUS|COOK CHORIONIC VILLUS SAMPLING (CVS) SET|LLX|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2000|06/12/2000|||APPR|APPROVAL FOR A SMALLER SIZE CVS SET (5.3 FR, 24 CM).
P850089|S043|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE Z/SP|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2000|01/28/2000|||OK30|The 30-day notice requested changes to the connector ring backfilling process.
P930039|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|SUREFIX|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2000|01/28/2000|||OK30|The 30-day notice requested changes to the connector ring backfilling process.
P930034|S015|Alcon Laboratories, Inc.|2501 DISCOVERY DRIVE,SUITE 500||ORLANDO|FL|32826|3714|Excimer laser system|INFINITY LS EXCIMER LASER SYSTEM|LZS|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/06/2000|02/03/2000|||APPR|Change tradename to Infinity LS Excimer Laser System
N17511|S013|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON HYSTEROSCOPY FLUID|LTA|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2000|02/09/2000|||OK30|The 30-day notice reqeusted the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility for the device.
P960004|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE/FINELINE ENDOCARDIAL PACING LEADS|DTB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/11/2000|02/23/2000|||APPR|Approval to market all previously marketed Intermidics shylets kits under new Guidant modelnumbers and provide an alternate stylet kit package insert.
P910073|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/11/2000|02/23/2000|||APPR|All previously marketed Intermedics stylets to be marketed under new Guidant model numbers 6032-6066,6765-6770,6826,6828,6963,6964,6971,6972,6983,and 6985.  Also approved an alternate stylet kit package insert
P830060|S047|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/11/2000|02/23/2000|||APPR|All previously marketed Intermedics stylets to be marketed under new Guidant model numbers, and an alternate stylet kit package insert.
P830061|S031|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE/CAPSURESP/NOVUS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2000|01/28/2000|||OK30|The 30-day notice requested a change in material used to manufacture the anchoring sleeves.
P850089|S044|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSUREZ NOVUS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2000|01/28/2000|||OK30|The 30-day notice requested a change in material used to manufacture the anchoring sleeves.
P930039|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSUREFIX/SUREFIX|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2000|01/28/2000|||OK30|The 30-day notice requested a change in material used to manufcture the anchoring sleeves.
P900043|S021|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/11/2000|02/04/2000|||APPR|(1)  the addition of a note in the Instructions for Use regarding correct prepping procedures for the balloon; (2) the addition of new width and height specifications for the inflation lumen tubing, and (3) the addition of an automated deflation test prior to product release.
P910058|S011|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES,MODEL C11UB|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2000|04/18/2000|||APPR|Approval for an alternate packaging configuration comprising a different lens carrier design and a single, rather than double, autoclavable pouch.
P900056|S034|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2000|02/16/2000|||APPR|The addition of a ground test to the calibration and final test procedure for the Rotablator console.
P970058|S006|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER M1000 SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/2000|04/17/2000|||APPR|Approval for a software change that impoves the device sensitivity for detecting masses and reduces the number of extraneous maks produced per case.
P910073|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/14/2000|04/11/2000|||APPR|Approval for an extra lead port to the the ENDOTAK SQ Array XP Subcutaneous Lead Model 0049 and a modified DF-1 terminal of: the ENDOTAK SQ Array XP Subcutaneous Lead Model 0049; ENDOTAK SQ Patch Lead Model 0047; ENDOTAK SQ Array Subcutaneous Lead Model 0049; DF-1 Lead Adapters Models 6833, 6835, 6931 and the Epicardial patches models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition.
P910077|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD, SQ PATCH LEAD, EPICARDIAL PATCHES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/14/2000|04/11/2000|||APPR|Approval for an extra lead port to the ENDOTAK SQ Array XP subcutaneous Lead Model 0049 and a modified DF-1 terminal of: the ENDOTAK SQ Array XP Subcutaneous Lead Model 0049; ENDOTAK SQ Patch Lead Model 0047; ENDOTAK SQ Array Subcutaneous Lead Model 0049; DF-1 Lead Adapters Models 6833, 6835, 6931 and the Epicardial Patches Models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition.
P970008|S014|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/2000|03/02/2000|||APPR|Approval for a modification to the software to add the auto-control option to the Targis System treatment.
P840001|S044|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2000|03/21/2000|||APPR|Approval for device and manufacturing process changes to the existing Model 7424 ITREL II Neurostimulator, for use in conjunction with the Medtronic Itrel Spinal Cord Stimulation System.
P960009|S009|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2000|03/21/2000|||APPR|Approval for device and manufacturing process changes to the existing Model 7424 ITREL II Neurostimulator, and rebranding of this device under the new tradename, Soletra Model 7426 Neurostimulator, for use in conjunction with the existing Medtronic Activa Tremor Control System.
P810046|S200|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/2000|02/16/2000|||APPR|A revision to the Instructions for Use booklet for ACS RX SOLARIS and ACS OTW SOLARIS Coronary Dilatation Catheters to include the addition fo the ACS Multi-Link Tristar Stent to the sections pertaining to post-implant stent dilatation.
P990020|S002|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2000|02/08/2000|||OK30|The 30-day notice requested changes to eliminate a final cleaning step and to add a supplier of nitinol tubing and as-cut stents.
P990020|S003|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2000|02/08/2000|||OK30|The 30-day notice reqeusted changes to eliminate a final cleaning step and to add a supplier of nitinol tubing and as-cut stents.
P900056|S035|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2000|02/11/2000|||OK30|The 30-day notice requested two changes;the addition of an inspection of the advancer short drive shaft following the wet test and an additional glue application during assembly of the large hypo tube and liner components.
P920023|S011|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESIS|MES|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2000|02/09/2000|||APPR|Modification to the delivery tool handle.
P970061|S008|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||RADIUS CORONARY STENT WITH DELIVERY SYSTEM||CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2000|02/11/2000|||APPR|Approval of the addition of two tensile strenght specifications for the pullwire assembly.
P930038|S023|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/2000|03/01/2000|||APPR|Approval for modifications to the anchor failure yield strength specifications.
P840001|S045|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 7421 ITREL(R), 7424 ITREL(R) II, 7425 ITREL(R) III AND MEDEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS|LGW|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/24/2000|06/13/2000|||APPR|APPROVAL FOR EXPANSION OF THE INDICATIONS FOR USE FOR MODEL 7421 ITREL(R), 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) DEVICES.  THESE DEVICES ARE INDICATED "AS N AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND LIMBS, INCLUDING-CHRONIC AND INTRACTABLE UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK...
P980001|S014|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIROYAL(TM) ADVANCE PREMOUNTED STENT SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2000|07/13/2000|||APPR|APPROVAL  FOR THE 4.5 AND 5.0 MM DIAMETER NIROYAL(TM) ADVANCE PREMOUNTED STENT SYSTEMS.
P860022|S052|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens, contact (other material) - daily|BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)|HQD|OP|THIRTY DAY TRACK|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2000|02/04/2000|||APPR|Approval under a 30-day notice for addition of one finishing laboratory, Procornea Nederland BV, Kollergan9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distributino site for the referenced devices.
P970058|S007|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER M1000 SYSTEM|MYN|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/2000|05/16/2000|||APPR|Approval for a change in labeling with respect to efficacy.
P830063|S002|BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N|MDP|GU|Normal 180 Day Track|Other Report|N|01/18/2000|08/28/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE REQUIREMENTS OF THE POST-MARKET STUDY FOR THE DEVICE.
P900043|S022|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2000|03/02/2000|||APPR|Modification of the manufacturing process to form balloon shoulders at the distal and proximal ends of the stent.
P880086|S069|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2000|02/18/2000|||OK30|The 30-day notice requested the elimination of in-process x-ray imaging for all bradycardia pulse generators.
P900070|S026|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||Programmer, pacemaker|TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO|KRG|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2000|02/18/2000|||OK30|The 30-day notice requested the elimination of in-process x-ray imaging for all bradycardia pulse generators.
P830045|S068|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO|KRG|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2000|02/18/2000|||OK30|The 30-day notice requested the elimination of in-process x-ray imgaing for all bradycardia pulse generators.
P970004|S007|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM FOR URINARY CONTROL THERAPY|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/15/2000|02/29/2000|||APPR|Approval for a quick guide to the Model 3031 Patient Programmer that will be provided to implanting physicians for distribution to both currently implanted and future patients.
P900056|S036|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2000|03/08/2000|||APPR|Approval for an additional step to the inspection procedure of the infusion tube to ensure adequate cleaning of the component.
P970015|S013|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||INTER FIX THREADED FUSION DEVICE||OR|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|02/02/2000|07/11/2000|||APPR|APPROVAL OF A POST APPROVAL STUDY FOR THE INTER FIX(TM) THREADED FUSION DEVICE.
P850079|S034|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A|LPM|OP|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|02/02/2000|05/05/2000|||APPR|Approval of a protocol to extend the shelf life of methafilcon A blister packaged products from three years to six years.
P830055|S068|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Express GMP Supplement|N|02/03/2000|03/06/2000|||APPR|Express supplement approval for manufacturing facility located at DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork, Ireland.
P900056|S037|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2000|03/08/2000|||APPR|Approval to add an additional step to the inspection procedure of the insert hub to confirm that the depth of the grooves are within specification.
P900043|S023|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|PALMAZ-SCHATZ(R) MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY(TM) OVER THE WIRE DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/04/2000|05/24/2000|||APPR|Approval for modifications to the labeling for the PALMAZ-SCHATZ MiniCrown Balloon-Expandable Stent with Dynasty Over-the-Wire Delivery System to include 6-month data.
P980001|S016|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR(TM) PREMOUNTED STENT SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2000|02/25/2000|||OK30|The 30-day notice requested to increase the tolerance allowed in the stent overlap to markerband placement by 0.25 mm (from 0.25mm to 0.50mm)
P990017|S005|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM/ANCURE ILIAC BALLOON CATHETER|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2000|03/24/2000|||APPR|Approval to add the Ancure Bifurcated Endograft with differential limb lengths to the product line.
P900043|S024|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/2000|07/21/2000|||APPR|APPROVAL FOR THE ADDITION OF A HEPARIN COATING TO THE BX VELOCITY(TM) CORONARY STENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR(TM) STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS  (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 TO 4.00 MM.
P910001|S018|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/2000|08/04/2000|||APPR|APPROVAL FOR THE VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER, MODEL 110-003.
P970004|S008|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM FOR URINARY CONTROL|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/29/2000|03/09/2000|||APPR|Approval for 1)elimination of the OR screening cable from the Model 3080 and 3886 lead kits, 2) to use the generic term "fluoropolymer" in place of "PTFE," and 3) to make numerous minor revisions to the Physician and Hospital Staff Manual for the Model 3012 Quadripolar Neurostimulator, Models 3080 and 3886 Leads, and Model 3095 Extension.
P970034|S004|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/2000|04/28/2000|||APPR|Approval for Allergan Surgical to distribute the Models RS-50B, RS-55B, RS-60B, RS-65, SP-60A, and SP-65A2 ultraviolet-absorbing posterior chamber intraocular lenses as Allergan's Duralens Models 52, 53, 54, 59, 60, and 65T, respectively.
P970034|S005|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2000|03/27/2000|||APPR|Approval for reducing the frequency of ethylene chlorohydrin residual testing from a quarterly basis to an annual basis.
P830055|S069|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM DESIGN MODIFICATION TO ROTATING PLATFORM BEARINGS|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2000|03/16/2000|||APPR|Approval for a design modification to the proximal articular surface of the LCS Rotating Platform Bearings to match the geometry of the PFC sigma femoral components that are implanted using slightly different distal cuts than the current LCS femoral components.
P840001|S046|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/10/2000|04/12/2000|||APPR|Approval for the Model 7499 Extension, Connector Boot, and Extension Passer Tunneling System, for use in conjunction with the Medtronic Itrel Spinal Cord Stimulation System.  Also, approval for labeling modifications.
P870015|S035|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|TRANSPORTABLE MODEL STS-T LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/15/2000|02/25/2000|||APRL|Approval for (1) minor changes to the labeling to minimize the risk of electrical shock from the U-arm, and (2) the additon of protective covers for the U-arm's electrical connections.
P910066|S014|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/15/2000|03/09/2000|||APPR|Approval for revisions to the Physician Manual and Package Insert, and the Patient Manual.
P890064|S007|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/2000|03/16/2000|||APPR|Approval for removal of the reagent component "Probe A" and Indication number 1.  The device, as modified, will be marketed under the trade name Digene High-Risk HPV DNA Test using Hybrid Capture.
P950018|S004|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2000|06/15/2000|||APPR|APPROVAL FOR THE FILTER STERILIZATION AND ASEPTIC FILL FACILITY LOCATED AT CHESAPEAKE BIOLOGICAL LABORATORIES (CBL), IND., BALTIMORE, MARYLAND 21230.
P830055|S070|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Express GMP Supplement|N|02/17/2000|03/30/2000|||APPR|Approval for the additional manufacturing facility located at DePuy-Raynham, a Division of DePuy Orthopaedics, Raynham, Massachusetts.
P950034|S014|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2000|03/23/2000|||APPR|Approval for the use of Denatured Alcohol 3C to precipitate the sodium hyaluronate/carboxymethylcellulose powder (HA/CMC) rather than ethyl alcohol.
P980031|S003|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS CORNEAL RING SEGMENTS|LQE|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2000|03/17/2000|||OK30|The 30-day Notice requested the implementation of modifications made to the tumble polishing and final cleaning process used for the Intacs corneal ring segments.
P960009|S010|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2000|04/12/2000|||APPR|Approval for the Model 7482 Extension, Connector Boot, and Extension Passer Tunneling System, for use in conjunction with the existing Medtronic Activa Tremor Control System.  Also approval for labeling modifications.
P970020|S020|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK DUET & TRISTAR CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2000|03/20/2000|||OK30|The 30-day Notice requested changes to the electropolishing parameters of the stent.  the reason for the change is to opitmize the efficiency of the electropolishing process.
P980031|S004|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS PRESCRIPTION INSERTS|LQE|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/2000|10/11/2001|||APPR|APPROVAL FOR 0.275 MM AND 0.325 MM INTACS(TM) AS WELL AS FOR A NEW TRADE NAME, "INTACS(TM) PRESCRIPTION INSERTS."
P980001|S017|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIROYAL(TM1) ELITE PREMOUNTED STENT SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/2000|08/03/2000|||APPR|APPROVAL FOR THE NIROYAL(TM) ELITE PROMOUNTED STENT SYSTEMS.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: *PATIENTS WITH SYMOPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 4.0 MM;  * TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED IN TERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND  * PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS WITH LESION LENGTH <= 30 MM AND REFERENCE DIAMETER IN THE RANGE OF 3.0 TO 4.0 MM.
P970051|S010|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|CI24R(ST) COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/2000|08/21/2000|||APPR|APPROVAL FOR A DESIGN MODIFICATION INCLUDING THE STRAIGHT ELECTRODE OF THE CI 24 M WITH THE 24 K DOWNSIZED STIMULATOR RECEIVER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CI 24R(ST), AND IS INDICATED FOR CHILDREN AGE 18 MONTHS THROUGH 17 YEARS OF AGE WHO HAVE BILATERAL PROFOUND SENSORINEURAL DEAFNESS AND DEMONSTRATE LITTLE OR NO BENEFIT FROM APPROPRIATE BINAURAL HEARING AIDS, AND FOR ADULTS, AGE 18 YEARS AND OLDER WHO HAVE BILATERAL MODERATE TO PROFOUND SENSORINEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FROM APPROPRIATE HEARING AIDS.
P980009|S005|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|02/25/2000|03/23/2000|||APPR|Approval for the alternate sterilization facility located at Gammaster Ireland Ltd., Westport, County Mayo, Ireland.
P890012|S005|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, extended wear|GENTLETOUCH (NETRAFILCON A)EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|02/28/2000|05/02/2000|||APPR|Approval for a manufacturing site transfer to Wesley Jessen Inc., Cidra, Puerto Rico.
P810046|S201|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CROSSSAIL/OPENSAIL CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/2000|06/05/2000|||APPR|APPROVAL FOR THE CROSSSAIL AND OPENSAIL CORONARY DILATION CATHETERS.  THESE CATHETERS ARE INDICATED FOR: (A) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND (B) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.
P950035|S006|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM|GZC|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/29/2000|07/05/2000|||APPR|APPROVAL FOR THE DISTRIBUTION OF AN INTRAMUSCULAR ELECTRODE AND INTRAMUSCULAR ELECTRODE INSERTION TOOL KIT AS COMPONENTS TO THE FREEHAND(TM) SYSTEM, AND LABELING CHANGES.
P980037|S002|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|POSSIS ANGIOJET(R) RHEOLYTIC(TM) THROMBECTOMY SYSTEM - CORONARY USE|MCX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/29/2000|03/17/2000|||APPR|Approval for the additiion of a label to the current inventory of the LF 140 Catheter which reads "Caution: Do not inject fluids in catheter outflow lumen".
P930029|S013|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|MEDTRONIC MODEL 4806 ATAKR II RF POWER GENERATOR|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/29/2000|11/27/2000|||APPR|APPROVAL FOR A NEW RF GENERATOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATAKR II AND IS INDICATED FOR INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA, TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA, AND CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P860019|S159|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/29/2000|03/24/2000|||APPR|Approval for a labeling change that advises the user not to use the PTCA catheter if the proximal shaft has been bent or kinked.
P960007|S014|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE(TM)|MGR|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2000|05/19/2000|||APPR|APPROVAL TO CONDUCT THE FINAL PRODUCT STERILITY TEST IN-HOUSE UNDER THE CONDITIONS OF AN ISOLATOR ENVIRONMENT.
P790017|S071|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2000|08/28/2000|||APPR|APPROVAL FOR THE R1S RAPID EXCHANGE BALLOON DILATATION CATHETER.  THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE R1S RAPID EXCHANGE BALLOON DILATATION CATHETER IS NOT INTENDED FOR USE AS A PTCA PERFUSION CATHETER BEYOND 60 SECONDS OF BALLOON INFLATION.
P900056|S038|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2000|03/24/2000|||APPR|Approval of a change in the acceptance criterion, from <= 15 psi to <= 13psi, for the quality assurance wet test for the A19 model.
P890043|S035|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/2000|04/06/2001|||APPR|APPROVAL FOR THE FLEXI-CUT(TM) DIRECTION DEBULKING SYSTEM.  THE FLEXI-CUT(TM) DIRECTION DEBULKING SYSTEM IS INDICATED FOR USE IN CORONARY ARTERY DISEASE ACCESSIBLE TO DCA (DIRECTIONAL CORONARY ATHERECTOMY), GENERALLY IN THE PROXIMAL OR MID-PORTION OF CORONARY VESSELS.  IT CAN BE USED ALONE OR IN CONJUNCTION WITH OTHER CORONARY INTERVENTIONAL DEVICES.  DCA IS INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER BY MECHANICALLY SHAVING AND REMOVING ATHEROSCLEROTIC MATERIAL FROM THE DISEASED VESSEL.
P900056|S039|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTAGLIDE LUBRICANT STERILIZATION VESSEL CHANGE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2000|04/01/2000|||OK30|Change in a vessel used in the air/steam sterilization of the Rotaglide Lubricant, an accessory to the Rotablator Rotational Angioplasty System.
P850079|S036|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2000|03/23/2000|||OK30|Introduction of an alternate manufacturing process for the extended wear contact lens.
P960025|S002|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE WITH VSP SPINE SYSTEM|MCV|OR|Normal 180 Day Track|Other Report|N|03/06/2000|02/28/2001|||APPR|APPROVAL FOR THE CLINICAL PROTOCOL FOR A POST-APPROVAL STUDY.
P950032|S017|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF(R)(GRAFTSKIN)|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/07/2000|06/16/2000|||APPR|APPROVAL FOR A CHANGE IN THE DESCRIPTION OF APLIGRAF FROM THE TERM "VIABLE" TO THE TERM "LIVING".
P930038|S024|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL|MGB|CV|Normal 180 Day Track|Express GMP Supplement|N|03/07/2000|03/23/2000|||APPR|Approval for an alternate sterilization facility located at SteriGenics International, Inc., Gurnee, Illinois.
P880086|S070|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/13/2000|04/06/2000|||APPR|Approval for the Integrity Afx DR Model and SR Model 5142.
P880086|S071|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFFINITY VDR MODEL 5430 PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/13/2000|04/06/2000|||APPR|Approval for the affinity VDR Model 5430 Pulse Generator.
P900056|S040|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM FLOPPY GOLD GUIDE WIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2000|04/01/2000|||OK30|Change to the manufacturing process of the Floppy Gold Guide Wire.
P930021|S004|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN|NQA|DE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2000|01/19/2001|||APPR|APPROVAL TO CHANGE FROM THE EMDOGAIN(R) TWO VIAL SYSTEM TO THE EMOGAIN(R) GEL FILLED STERILE SYRINGES.
N50510|S128|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID|LTW|MI|Normal 180 Day Track||N|03/09/2000|04/17/2000|||APPR|Approval for the addition of the antibiotic ticarcillin/clavulanic acid at concentrations of 8/2, 32/2, 64/2 ug/ml ot the Vitek 2 Gram Negative Susceptibility Test System.
N50510|S129|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM|LTW|MI|Normal 180 Day Track||N|03/09/2000|04/26/2000|||APPR|The device, as modified, will be marketed under the trade name Vitek 2 Gram Negative Susceptibility Test Cards. Approval for the addition of the antibiotic imipenem at concentrations of 2, 4 and 16 micrograms/ml to the Vitek 2 Gram Negative Susceptibility Test System.
P920004|S012|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL ES (ES DEVICE)|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/10/2000|04/10/2000|||APPR|Approval for changes to the Instructions for Use.
P990020|S004|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2000|04/12/2000|||OK30|30-Day notice requested the addition of suppliers of sewn stent grafts.
P900023|S032|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/13/2000|05/12/2000|||APPR|Approval for the Instructions for Use for the BVS 5000 Cannulae that were modified to address specific concerns associated with the Hemashield graft and the silicone-coated graft.
P850007|S025|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/2000|05/31/2000|||APPR|APPROVAL TO MODIFY THE PHYSIO-STIM, MODEL 7215 AS FOLLOWS: 1.  COMBINE THE TRANSDUCER AND CONTROL UNITS INTO A SINGLE UNIT; 2. POWER THE DEVICE WITH ONE 9-VOLT DISPOSABLE BATTERY RATHER THAN A MULTIPLE CELL NI-CAD BATTERY PACK WITH CHARGER UNIT; 3. BASED ON THE ABOVE CHANGES, REDUCE THE WEIGHT AND OVERALL DIMENSIONS OF THE DEVICE; 4. INDICATE THE OPERATING STATUS OF THE DEVICE WITH THREE LED SIGNAL LIGHTS RATHER THAN AN LCD READOUT; AND 5. CONTROL POWER TO THE DEVICE WITH AN ON/OFF BUTTON RATHER
P930039|S009|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSUREFIX(R)|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/2000|08/31/2000|||APPR|APPROVAL FOR AN EXTENDABLE/RETRACTABLE SCREW-IN PACING LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MEDTRONIC CAPSURE(R)FIX NOVUS MODEL 5076 AND VITATRON CRYSTALLINE(R) ACTFIX MODEL ICF09 PACING LEADS.  THESE DEVICES ARE INDICATED FOR PERMANENT PACING AND SENSING OF THE VENTRICLE AND/OR ATRIUM WHEN USED WITH A COMPATIBLE PULE GENERATOR.
P980022|S003|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325|||CONTINUOUS GLUCOSE MONITORING SYSTEM||CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2000|03/10/2000|||APPR|Approval for the Sen-Serter Auto Inserter to be used with the MiniMed Continuous Glucose Monitoring System as an aid for insertion of the MimiMed Glucose Sensor.
P960040|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM DR/VR HE AICD|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/05/2000|07/13/2000|||APPR|APPROVAL FOR THE SOFTWARE THAT CONTROLS PROGRAM/RECORDER/MONITORS MODELS 2901 AND 2910.
P950035|S007|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM|GZC|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|03/14/2000|06/23/2000|||APPR|APPROVAL FOR THE DISTRIBUTION OF AN IMPLANT TESTER ACCESSORY WHICH IS USED IN FINAL DEVICE TESTING AT THE COMPLETION OF SURGERY.
P990017|S006|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/15/2000|04/14/2000|||APPR|Approval for the addition of a hydrophilic coating with the trade name HYDRACOAT to the outer surface of the ANCURE Delivery Catheter jacket.
P900056|S041|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2000|04/10/2000|||APPR|Approval for a quality control change that increases the monitoring of the strike bath used in the gold plating process of the Floppy Gold Guide Wire.
P900056|S042|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2000|04/04/2000|||OK30|Change to the manufacturing process of the Rotablator RotaLink Advancer/Catheter.
P900056|S043|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2000|04/11/2000|||APPR|Approval for a quality control change that increases the number of times the burr size is verified or measured during the manufacturing process.
P970020|S021|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/2000|09/08/2000|||APPR|APPROVAL FOR THE ACS MULTI-LINK RX AND OTW ULTRA(TM) CORONARY STENT SYSTEMS.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYNTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM TO 5.0 MM; AND 2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 3.5 MM TO 5.0 MM.  LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. NOTE:  THE 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE.
P990019|S001|DUSA PHARMACEUTICALS, INC.|25 UPTON DR.||WILMINGTON|MA|01887||SYSTEM, LASER, PHOTODYNAMIC THERAPY|BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR|MVF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/20/2000|09/26/2000|||APPR|APPROVAL FOR THE MODIFIED VERSION OF THE BLU-U(TM) BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BLU-U(TM) MODEL 4170.
P950022|S008|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2000|04/19/2000|||OK30|Designation of alternate vendor of the silicone materials and medical adhesives used in the TVL and SPL tachycardia leads.
P950019|S011|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION|MAX|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2000|03/30/2000|||OK30|REMOVAL OF THE POST STERILIZATION INSPECTION FOR THE RAY THREADED FUSION CAGE WITH INSTRUMENTATION.
P940031|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN/PULSAR PACEMAKERS|LWP|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2000|06/20/2000|||APPR|APPROVAL TO MARKET BOTH COATED AND UNCOATED VERSIONS OF THE ABOVE PACEMAKERS.
P980001|S018|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEM||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/22/2000|04/25/2000|||APPR|Approval for an addition of a note to the Instructions for Use of the NIR Primo Premounted Stent System.
P880027|S057|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BOSTON SCIENTIFIC SCIMED PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Express GMP Supplement|N|03/22/2000|04/26/2000|||APPR|Approval for a manufacturing site located at Boston Scientific Ireland Ltd., Galway, Ireland and for a sterilization site located at Isotron Ireland Ltd, County Offaly, Ireland.
P940022|S014|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/22/2000|07/13/2000|||APPR|APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR POST-LINGUAL SEVERE TO PROFOUND HEARING LOSS WHERE LIMITED BENEFIT HAS BEEN OBTAINED WITH THE USE OF HEARING AIDS.
P890017|S008|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMZ BALLOON EXPANDABLE STENTS|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2000|07/11/2000|||APPR|APPROVAL TO MODIFY THE DEVICE LABELING TO SPECIFY THE CORDIS MAXI DS BALLOON CATHETER AS THE RECOMMENDED DELIVERY SYSTEM FOR THE P308 PALMAZ(TM) BALLOON EXPANDABLE STENT.
P960043|S022|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||CLOSER 6 FR. SUTURE-MEDIATED CLOSURE DEVICE||CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2000|05/19/2000|||APPR|APPROVAL FOR A MODIFICATION TO THE MECHANISM FOR FOOT DEPLOYMENT AND FOOT PARKING OF THE CLOSER(TM) SMC DEVICE.
P960025|S003|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE WITH VSP SPINE SYSTEM|MCV|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2000|04/10/2000|||APPR|Approval of additional sizes for the Lumbar I/F Cage.
P980046|S002|HOME ACCESS HEALTH CORP.|2401 W. HASSELL|SUITE 1510|HOFFMAN ESTATES|IL|60195|5200|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|HEPATITIS C CHECK TESTING SERVICE|MZO|MI|30-Day Notice||N|03/23/2000|04/12/2000|||OK30|As a final packaging option, the outer packaging of the Hepatitis C Check product may be assembled in a Softpak package or the currently approved paperboard packaging when shipped directly to clients.
P940002|S003|SULZERMEDICA|9900 SPECTRUM DR.||AUSTIN,|TX|78717||PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NATURAL KNEE & NATURAL KNEE II|MBD|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2000|04/18/2000|||APPR|Approval for use of forged Ti alloy as a material for the construction of the stemmed tibial base plate component of the devices.
P960047|S002|HOWMEDICA OSTEONICS CORP.|59 ROUTE 17 SOUTH||ALLENDALE|NJ|07401|1677||OSTEONICS CONSTRAINED ACETABULAR INSERT||OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2000|05/01/2000|||APPR|Approval for the addition of the Trident Constrained Acetabular insert design, and the Modified PCA Co Cr, Modified V40 Co Cr, PCA CoCr+15 mm, PCA Zirconia and V40 Zirconia Femoral Heads to the Osteonics Constrained Acetabular Insert PMA.
P970010|S002|SYNTHES (USA)|1690 RUSSELL RD.|POST OFFICE BOX 1766|PAOLI|PA|19301||BONE CEMENT|NORIAN SRS CEMENT|LOD|PM|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|03/02/2000|04/28/2000|||APPR|Approval of the real time shelf life protocol for purposes of extending the shelf life.
P970021|S003|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/28/2000|08/14/2000|||APPR|APPROVAL FOR REVISED LABELING THAT INCLUDES THREE-YEAR POST-TREATMENT INFORMATION, AS REQUIRED AS A CONDITION OF APPROVAL FOR THE ORIGINAL PMA APPLICATION.
P870018|S024|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR MODULARIS|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2000|04/17/2000|||APRL|Approval for a LithoShare option for the Lithostar Modularis.
P960016|S004|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC COMPASS STEERABLE ELECTROPHYSIOLOGY CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/2000|06/14/2001|||APPR|APPROVAL FOR 1 (ONE) YEAR SHELF-LIFE, THE INCORPORATION OF ADDITIONAL ELECTRODES FOR STIMULATION AND MAPPING (10 ELECTRODES TOTAL), AND OTHER MINOR DEVICE MODIFICATIONS.  THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC COMPASS CATHETER AND IS INDICATED FOR USE FOR CARDIAC ELECTROPHYSIOLOGICAL. MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL BLOCK RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETION AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR TO AN ATRIAL ARRHYTHMIA.
P830055|S072|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM: REMAINING ULTRAHIGH MOLECULAR WEIGHT POLYETHYLENE DEVICES|NJL|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2000|04/28/2000|||APPR|Approval to allow the option of manufacturing all approved LCS Total Knee System Ultra High Molecular Weight Polyethylene (UHMWPE) components vacuum-packaged in foil bags and gamma radiation sterilized (the GVF process).
P840045|S006|MEDICEM TECHNOLOGY S.R.O|KARLOVARSHA TRIDA 20||KAMENNE ZEHROVICE||27301||dilator, cervical, synthetic, osmotic, pregnancy termination|DILAPAN-S|LOB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2000|10/25/2002|||APPR|APPROVAL FOR A NEW DEVICE DESIGN AND NEW MANUFACTURING LOCATION.  THE DEVICE, AS MODIFIED AND WITH REVISED LABELING, WILL BE MARKETED UNDER THE TRADE NAME DILAPAN-S AND IS INDICATED FOR DILATATION OF THE CERVIX UTERI PRIOR TO TERMINATION OF PREGNANCY UP TO 16 WEEKS GESTATION.  A SINGLE DILAPAN-S IS INSERTED INTO THE ENDOCERVICAL CANAL AND MAY REMAIN IN SITU FOR UP TO FOUR HOURS.  THE DEVICE WILL BE MANUFACTURED AT A NEW FACILITY LOCATED AT GELMED INTERNATIONAL, IN THE CZECH REPUBLIC AND STERILIZED AT A CONTRACT STERILIZATION FACILITY LOCATED AT BIOSTER A.S., IN THE CZECH REPUBLIC.
P860019|S160|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER|LOX|CV|Normal 180 Day Track||N|03/31/2000|09/27/2000|||APPR|APPROVAL FOR THE BOSTON SCIENTIFIC SCIMED MAVERICK(TM) MONORAIL(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (9, 12, 25, AND 30 MM LENGTHS WITH BALLOON DIAMETERS OF 2.0 - 4,0 MM IN 1/4 MM INCREMENTS, AND 15 AND 20 MM LENGTHS WITH BALLOON DIAMETERS OF 1.5 MM AND 2.0 - 4.0 MM IN 1/4 MM INCREMENTS.  THE MAVERICK(TM) MONORAIL PTCA CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE MAVERICK(TM) MONORAIL PTCA CATHETER (2.25 - 4.0 MM BALLOON DIAMETERS) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P910066|S015|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|SPINALOGIC BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2000|08/23/2000|||APPR|APPROVAL TO *REMOVE THE FOLLOWING PRECAUTION FROM THE SUMMARY OF SAFETY AND EFFECTIVENESS AND PROFESSIONAL LABELING; "THE SAFETY AND EFFECTIVENESS OF THE SPINALOGIC(R) HAS ONLY BEEN STUDIED IN PATIENTS HAVING SPINAL FUSION TREATMENT.  THE SAFETY AND EFFECTIVENESS OF THIS DEVICE IN PATIENTS RECEIVING INSTRUMENTATION, WHICH MAY DISTORT THE MAGNETIC FIELD GENERATED BY THE DEVICE AND THUS PRODUCE A LESS EFFECTIVE TREATMENT, HAS NOT BEEN ESTABLISHED"; AND *MODIFY THE FOLLOWING STATEMENT I NTHE RISKS AND BENEFITS SECTION OF THE PATIENT LABELING FROM: "THE SAFETY AND BENEFIT OF THE SPINALOGIC(R) WAS NOT STUDIED FOR PATIENTS WHO ALSO HAVE METAL IMPLANTS AT THE SPOT OF THEIR BACK SURGERY," TO "THE SPINALOGIC(R) WAS NOT STUDIED FOR PATIENTS WHO ALSO HAVE METAL IMPLANTS AT THE SPOT OF THEIR BACK SURGERY."
N50510|S130|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM NEGATIVE AST FOR CEFEPIME|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/2000|05/18/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CEFEPIME AT CONCENTRATIONS OF 2, 8, 16 AND 32 MICROGRAMS/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK 2 SYSTEM.
P830055|S073|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2000|05/19/2000|||APPR|Approval for design modifications to the LCS Total Knee System Femoral Components.
P900009|S009|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000|LPQ|OR|Normal 180 Day Track|Express GMP Supplement|N|04/03/2000|06/22/2000|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY AT SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION, MEMPHIS, TENNESSEE 38116.
P940015|S005|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC (HYLAN G-F 20)|MOZ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2000|09/12/2000|||APPR|APPROVAL FOR A LABELING CHANGE EXTENDING THE TIME OF TREATMENT EFFECT TO 26 WEEKS.
P960043|S023|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIES||CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2000|05/19/2000|||APPR|Approval for a manufacturing modification to the Snared Knot Pusher, and accessory of The Closer SMC Device.
P960043|S024|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||CLOSER 6 FR. SUTURE MEDIATED CLOSURE DEVICE||CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2000|05/19/2000|||APPR|APPROVAL FOR A MODIFICATION TO THE MARKER TUBE OF THE CLOSER(TM) SMC DEVICE.
N50510|S131|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR CEFOTAXIME|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/2000|06/06/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CEFOTAXIME AT CONCENTRATIONS OF 0.06, 0.25, 0.5 AND 1 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO CEFOTAXIME IN THE RANGE OF <=0.06 TO >=4 MICROGRAMS/ML.
N50510|S132|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR CHLORAMPHENICOL|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/2000|06/08/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CHLORAMPHENICOL AT CONCENTRATIONS OF 2, 8 AND 16 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO CHLORAMPHENICOL IN THE RANGE OF <=2 TO >=32 MICROGRAMS/ML.
N50510|S133|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/2000|06/09/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC BENZYLPENICILLIN AT CONCENTRATIONS OF 0.03, 0.06, 0.25 AND 0.5 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO BENZYLPENICILLIN IN THE RANGE OF <=0.06 TO >=2 MICROGRAMS/ML.
P970020|S022|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX TRISTAR/ACS MULTI-LINK OTW TRISTAR|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|04/06/2000|05/16/2000|||APPR|Approval for an alternate manufacturing facility located at Guidant Corporation, Guidant Ireland located in County Tipperary, Ireland, and an alternate sterilization facility located in Oxfordshire, United Kingdom.
N50510|S134|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR ERYTHROMYCIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2000|06/14/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC ERYTHROMYCIN AT CONCENTRATIONS OF 0.12, 0.25 AND 0.5 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE, AS MOFIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO ERYTHROMYCIN IN THE RANGE OF <=0.06 TO >=1 MICROGRAMS/ML.
N50510|S135|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR CEFTRIAXONE|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2000|06/21/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CEFTRIAXONE AT CONCENTRATIONS OF 0.06, 0.25, 0.5, AND 1 MICROGRAM/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO CEFTRIAXONE IN THE RANGE OF ,+0.06 TO >=4 MICROGRAMS/ML.
N50510|S136|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR TETRACYCLINE|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2000|06/21/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC TETRACYCLINE AT CONCENTRATIONS OF 0.5, 1 AND 2 MICROGRAMS/.ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE, AD MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO TETRACYCLINE IN THE RANGE OF <=1 TO >=16 MICROGRAMS/ML.
P960025|S004|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE WITH VSP SPINE SYSTEM|MCV|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2000|01/12/2001|||APPR|APPROVAL FOR THE USE OF THE LUMBAR I/F CAGE COMPONENT OF THE LUMBAR I/F CAGE(R) WITH VSP(R) SPINE SYSTEM WITH ADDITIONAL PEDICLE SCREW SPINAL SYSTEMS.  SPECIFICALLY, FOR USE WITH THE FOLLOWING SIX ADDITIONAL POSTERIOR PEDICLE SCREW SPINAL SYSTEMS:  1) THE TI ALLOY VERSION OF THE VSP SPINE SYSTEM;  2) TI ALLOY AND STAINLESS STEEL VERSIONS OF THE ISOLA SPINE SYSTEM;  3) TIMX SPINE SYSTEM; AND  4) THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE MOSS MIAMI SPINE SYSTEM.  IN ADDITION, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMBAR I/F CAGE SYSTEM.  THE INDICATION FOR THESE IMPLANTS HAS NOT BEEN CHANGED FROM THAT APPROVED ON FEBRUARY 2, 1999.
P860019|S161|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2000|04/26/2000|||OK30|Change in manufacturing method from an acid-etch to a centerless grinding process for the  distal taper in the corewire subassembly in fixed wire models of PTCA catheters, including the Long ACE, Graft ACE, PIVOT, and ACE.
P860004|S045|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC ONE PIECE VASCULAR CATHETERS|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2000|04/14/2000|||APPR|Approval for changes in the Anchor Rings - The anchor rings at the tip of the Model 8700A catheter are to be changed from a tapered design to a smaller, rounded bead design at the distal end of the catheter; changes to the Catheter Tubing Composition - the composition of the tubing for the Model 8700A, Model 8700V, and Model 8702 catheters is to be changed to Biomedical Grade ETR Q7-4765; changes to the Technical Manual - the Model 8700A, Model 8700V, and Model 8702 catheters are covered in the same technical manual.
P950037|S011|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|PHILOS PULSE GENERATOR|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2000|06/28/2000|||APPR|APPROVAL FOR THE USE OF A DIFFERENT SUBSTRATE MATERIAL (DYCOSTRATE(R).
N50510|S137|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/2000|06/21/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC OFLOXACIN AT CONCENTRATIONS OF 1, 2 AND 4 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO OFLOXACIN IN THE RANGE OF <-1 TO >=8 MICROGRAMS/ML.
N50510|S138|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/2000|08/11/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC VANCOMYCIN AT CONCENTRATIONS OF 0.5 AND 1 UG/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO VANCOMYCIN IN THE RANGE OF <=1 TO >=2 MICROGRAMS/ML.
P980035|S007|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||KAPPA 706 SR IPG||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2000|05/11/2000|||APPR|Approval for a modification to header part number 149422 for use with the Kappa SR Model 706.
P960011|S004|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2000|03/23/2001|||APPR|APPROVAL FOR CIBA VISION TO MARKET BIOLON(TM) 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY IN THE UNITED STATES UNDER THE TRADE NAME "UNIVISC".
P790005|S042|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOGEN(R) D40 IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2000|05/10/2000|||APPR|Approval for a two lead OsteoGen Implantable Bone Growth Stimulator.
N50510|S139|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/2000|06/26/2000|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC TRIMETHOPRIM/SULFAMETHOXAZOLE AT CONCENTRATIONS OF 2/38, 8/152, 16/304 AND 32/608 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO TRIMETHOPRIM/SULFAMETHOXAZOLE IN THE RANGE OF <=0.5/9.5 TO >=16/304
P810002|S051|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MASTERS SERIES COATED AORTIC VALVED GRAFT|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/12/2000|05/05/2000|||APPR|Approval for change to the method of forming the vascular graft taper and an increase in the sewing cuff fabric diameter per valve graft size.
P860019|S162|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/2000|10/05/2000|||APPR|APPROVAL FOR THE BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE (OTW) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (9, 12, 15, 20, 25 AND 30 MM LENGTHS WITH BALLOON DIAMETERS OF 2.0 - 4.0 MM IN 1/4 MM INCREMENTS, AND 9, 15 AND 20 MM LENGTHS WITH BALLOON DIAMETERS OF 1.5 MM).  THE MAVERICK(TM) OTW PTCA CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE MAVERICK(TM) OTW PTCA CATHETER (2.25 - 4.0 MM BALLOON DIAMETERS) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P930016|S011|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/12/2000|04/20/2000|||APPR|The device, as modified, will be marketed under the trade name VISX STAR S3Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (PRK) and myopic and astigmatic laser assisted in-situ keratomileusis (LASIK).
P910062|S001|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/12/2000|04/20/2000|||APPR|The device, as modified, will be marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (PRK) and myopic and astigmatic laser assisted in-situ keratomileusis (LASIK).
P990010|S001|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/12/2000|04/20/2000|||APPR|The device, as modified, will be marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (PRK) and myopic and astigmatic laser assisted in-situ keratomileusis (LASIK).
P970020|S023|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/2000|10/03/2000|||APPR|APPROVAL FOR THE ACS MULTI-LINK RX AND OTW TETRA(TM) CORONARY STENT SYSTEMS.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM; AND  2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 MM TO 4.0 MM.  LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  NOTE:  THE 2.5 MM AND 2.75 MM DIAMETER STENTS AND THE 33 MM AND 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED  ABRUPT CLOSURE.
P970035|S019|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S670 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2000|05/11/2000|||OK30|Requesting that the three-step manufacturing process of the distal and intermediate tubing be reduced to a two-step manufacturing process of the distal and intermediate tubing be reduced to a two-step process whereby the forming step will be completely removed and the tubing will be extruded to the final dimensions.
P950001|S006|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2000|05/19/2000|||APPR|Approval for: 1) use of a new mechanically interlocking component design to connect the terminal pin to the terminal ring, and 2) use of a shorter IS-1 connector terminal.
P960009|S012|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/18/2000|04/28/2000|||APPR|Approval to correct an inaccuracy in Medtronic's technical manual, patient manual, and other corresponding documentation.
P970034|S006|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2000|08/31/2000|||APPR|APPROVAL TO EXTEND THE POWER RANGE FOR YOUR LENSES TO INCLUDE POWERS BETWEEN +3.5 AND -12.0 DIOPTERS (EXCLUDING ZERO DIOPTER) IN 0.5 DIOPTER INCREMENTS.
P900056|S044|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2000|05/15/2000|||OK30|Modify the release criteria for sterile loads by removing the Product Verification testing after sterilization.
P950005|S008|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|BIOSENSE WEBSTER TEMPERATURE CABLES|DRF|CV|Normal 180 Day Track|Express GMP Supplement|N|04/19/2000|05/30/2000|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCARTED AT BIOSENSE WEBSTER, INC., CORDIS DE MEXICO, CHIHUAHUA, MEXICO.
P970004|S009|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION SYSTEM|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/2000|10/18/2000|||APPR|APPROVAL FOR THE MODEL 3095A LEAD EXTENSION KIT FOR USE WITH THE MEDTRONIC(R) INTERSTIM(R) SYSTEM FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE, URINARY RETENTION, AND SIGNIFICANT SYMPTOMS OF URGENCY/FREQUENDY IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
P990023|S001|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2000|05/19/2000|||APPR|Approval for changing the finish product's pH release specification from 7.0-7.4 to 6.9-7.1.
P960011|S005|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2000|05/19/2000|||OK30|Sterility release be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and that external sterility testing of Biolon syringe surfaces be discontinued.
P900009|S010|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|SONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM)|LPQ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/2000|05/10/2000|||APPR|Approval for a change in the wording of the indication statement.
P830060|S048|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6577 STERILIZABLE TELEMETRY WAND|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2000|05/30/2000|||APPR|APPROVAL FOR THE MODEL 6577 STERILIZABLE TELEMETRY WAND.
P970053|S003|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/2000|10/25/2000|||APPR|APPROVAL FOR THE INCORPORATION OF THE NOMOGRAM FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS INTO THE NIDEK EC-5000 SOFTWARE, ALONG WITH THE NOMOGRAM FOR PRK FOR MODERATE MYOPIA WITH ASTIGMATISM.
P850035|S025|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2000|09/27/2000|||APPR|APPROVAL FOR REVISED LABELING BASED ON THE FINDINGS OF THE POST-APPROVAL STUDY FOR THE SPF(R) IMPLANTABLE BONE GROWTH STIMULATOR.
P920004|S013|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL ES DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2000|08/03/2001|||APPR|APPROVAL TO MODIFY THE IFU FOR THE VASOSEAL ES DEVICE TO INCLUDE ANGIOGRAPHY DATA.
P860026|S006|AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHRAGMATIC PACEMAKER PHRENIC NERVE|GZE|AN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/27/2000|07/07/2000|||APPR|APPROVAL FOR PROCESS VALIDATION OF THE PROPOSED DEVICE STERILIZATION PROCEDURE, PROPOSED LABELING FOR THE DEVICE PACKAGING, AND THE PROPOSED CHANGES TO THE INSTRUCTION MANUAL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MARK IV AND IS INDICATED FOR PERSONS WHO REQUIRE CHRONIC VENTILATORY SUPPORT BECAUSE OOF UPPER MOTOR NEURON RESPIRATORY MUSCLE PARALYSIS (RMP) OR BECAUSE OF CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION
P970035|S020|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S670 W/DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2000|05/16/2000|||OK30|Changes to modify the electropolish process.
P980001|S019|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2000|05/30/2000|||OK30|MINOR MODIFICATION TO AN IN-PROCESS MANUFACTURING STEP FOR THE BALLOON COMPONENT OF THE NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEM.
P900023|S033|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2000|06/22/2000|||APPR|APPROVAL FOR A 36 FRENCH POLYURETHANE ARTERIAL CANNULA WITH A STAINLESS STEEL WIRE REINFORCED COIL AND A 10 MM HEMASHIELD(R) GRAFT.
P960058|S013|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2000|06/16/2000|||APPR|APPROVAL FOR THE FABRICATION PROCESS CHANGE FOR THE INTEGRATED CIRCUITS IN THE DEVICE.
P940022|S015|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2000|06/16/2000|||APPR|APPROVAL FOR THE FABRICATION PROCESS CHANGE FOR THE INTEGRATED CIRCUITS IN THE DEVICE
P950037|S012|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2000|06/22/2000|||APPR|APPROVAL FOR THE PHILOS PULSE GENERATOR FAMILY AND THE SWM1000 B-K00.0.U SOFTWARE CARTRIDGE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PHILOS DR, PHILOS DR-B, PHILOS D, PHILOS SR, PHILOS SR-B, PHILOS S, PHILOS SLR, AND THE SWM1000 B-K00.0.U SOFTWARE CARTRIDGE.
P960004|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE II/ FINELINE II PACING LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2000|06/07/2000|||OK30|FIVE MINOR CHANGES MADE TO THE THINLINE II(TM) AND FINELINE II(TM) MANUFACTURING PROCESSES.
P830055|S074|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2000|06/22/2000|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE ROTATING PLATFORM TIBIAL TRAYS AND BEARINGS THAT WERE ORIGINALLY SUBMITTED AND APPROVED AS PART OF SUPPLEMENTS 57, 61, AND 69.
P960004|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE(TM)II/FINELINE(TM) II LEADS|DTB|CV|Normal 180 Day Track|Express GMP Supplement|N|05/15/2000|06/09/2000|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT GUIDANT PUERTO RICO B.V., DORADO, PUERTO RICO, 00646 AND THE STERILIZATION FACILITY LOCATED AT GUIDANT CORPORATION, ST. PAUL, MINNESOTA, 55112.
P880086|S072|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/24/2000|06/15/2000|||APPR|APPROVAL FOR THE MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER.
P830045|S069|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/24/2000|06/15/2000|||APPR|APPROVAL FOR THE MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER.
P880006|S031|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/24/2000|06/15/2000|||APPR|APPROVAL FOR THE MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER.
P930038|S025|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/2000|07/17/2000|||APPR|APPROVAL FOR A MODIFICATION TO THE DEPLOYMENT FORCE SPECIFICATION.
P990001|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON DIVA PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/2000|07/26/2000|||APPR|APPROVAL FOR THE PARYLENE COATED VERSION OF THE SELECTION AFM 902 PULSE GENERATOR AND THE MODEL VSA02, VERSION 6.0 PROGRAMMER SOFTWARE.
P990001|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON(R) DEMA PACING SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2000|11/13/2000|||APPR|APPROVAL FOR THE DEMA PACING SYSTEM AND THE CITATRON APPLICATION SOFTWARE MODEL VSA02, VERSION 6.  THE DEMA PACING SYSTEM CONSISTS OF THE FOLLOWING PULSE GENERATORS: CLARITY DDR MODELS 860, 862, 865; CLARITY SSIR MODELS 560, 562, 565; DIAMOND 3 MODEL 840; RUBY 3 MODEL 740; TOPAZ 3 MODEL 540; JADE 3 MODEL 340; VITA 2 DDR MODEL 830; VITA 2 MODEL 530.
P870049|S030|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN(R) RAPID FLUOROGENIC PANELS|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/17/2000|06/05/2000|||APPR|APPROVAL FOR LABELING CHANGE THAT ADDS A CONTRAINDICATION TO THE GRAM NEGATIVE MICROSCAN RAPID FLUOROGENIC PANELS OF "DO NOT REPORT" WHEN TESTING ALL GRAM NEGATIVE ORGANISMS WITH CEFOPERAZONE USING EITHER THE MIC OR BREAKPOINT FORMATS.
P870056|S013|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2000|06/16/2000|||OK30|CHANGE IN VENDOR SUPPLIER FOR THE MATERIAL IDENTIFIED AS POLYESTER.
P870077|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS, MODELS 6625LP/ESR|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2000|06/16/2000|||OK30|CHANGE IN VENDOR SUPPLER FOR THE MATERIAL IDENTIFIED AS POLYESTER.
P860057|S013|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE, MODELS 2700 AND 2800|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2000|06/16/2000|||OK30|CHANGE IN VENDOR SUPPLIER FOR THE MATERIAL IDENTIFIED AS POLYESTER.
P980035|S008|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC SIGMA SERIES PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM||CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2000|10/10/2000|||APPR|APPROVAL FOR MODIFICATIONS TO THE SIGMA AND 350 PACING SYSTEMS, SPECIFICALLY:  MODIFY THE BOTTOM OF THE CONNECTOR BY ADDING A 0.020 RECESS ON THE UNDERSIDE AREA BETWEEN THE CONNECTOR AND THE CAN; CHANGE INTERCONNECT RIBBON MATERIAL; MODIFY CONNECTOR ICR AREA BY ADDING WALLS BETWEEN INTERCONNECT RIBBONS; MODIFY ICR WELD CONFIGURATION; CHANGE MATERIAL FOR SET SCREW BLOCKS; MODIFY 3.2MM CONNECTOR BORES; INCREASE POLYURETHANE THICK NESS ON OUTSIDE OF CONNECTOR IN ULTRASONIC WELD ZONES; PREFORMED ICRS; MINIMUM ADHESIVE FILL LINE ADDED AROUND THE PERIMETER OF THE FILL AREA
P920014|S011|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE 1000A IP LVAS|DSQ|CV|Normal 180 Day Track|Other Report|N|05/15/2000|07/20/2000|||APPR|APPROVAL OF THE PROTOCOL TO BE USED TO EXTEND THE SHELF LIFE FROM 2 YEARS TO 3 YEARS FOR PRODUCTS THAT ARE ETHYLENE OXIDE (EO) STERILIZED PER SPECIFICATION 24215 REV G IN THE FOLLOWING TYPES OF PACKAGING: BLISTER TRAY 0.040" PETG WITH TYVEK 1073B LID (COATED ONE SIDE WITH ADHESIVE) AND TYVEK POUCHES (INNER AND OUTER POUCHES) MADE WITH 1073B TYVEK, SEALED TO 48 GA PETG/2.0 MIL POLYETHYLENE.
P810031|S023|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON 5 SODIUM HYALURONATE|LZP|OP|Normal 180 Day Track||N|05/12/2000|11/22/2000|||APPR|APPROVAL FOR HEALON(R)5 SODIUM HYALURONATE VISCOELASTIC.
P950037|S013|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|ACTROS SLR PULSE GENERATOR|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/08/2000|10/13/2000|||APPR|APPROVAL FOR REMOVAL OF THE WARNING LABEL WHICH RECOMMENDED PROGRAMMING DYNAMIC HYSTERESIS ON WHEN THE DEVICE IS PROGRAMMED TO THE VDDR MODE.
N17004|S012|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT|LOD|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2000|06/20/2000|||APPR|APPROVAL FOR CHANGE TO THE PACKAGING OF THE PRODUCT.
P970015|S014|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132|||INTERFIX THREADED FUSION DEVICE||OR|Normal 180 Day Track|Express GMP Supplement|N|05/23/2000|08/09/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SOFAMOR DANEK MANUFACTURING, WARSAW, INDIANA 46582.
P970043|S008|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|SUMMIT AUTONOMOUS LADARVISION 4000 SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/05/2000|07/11/2000|||APPR|APPROVAL FOR THE CORRESPONDING COMPANY NAME CHANGE, DEVICE NAME CHANGE, AND SOME EXTERNAL CHANGES TO THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUMMIT AUTONOMOUS LADARVISION 4000 LASER SYSTEM.
P860019|S163|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM RANGER, NC RANGER, COYOTE, AND MAXXUM PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2000|06/14/2000|||OK30|MINOR MODIFICATIONS TO THE EXISTING TRIFORMING AND TRIFOLDING MANUFACTURING PROCESS USED FOR THE QUANTUM RANGER, NC RANGER, COYOTE, AND MAXXUM PTCA CATHETERS.
P940010|S009|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM|MVG|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/17/2000|09/29/2000|||APPR|APPROVAL FOR MODIFICATION OF THE OPTIGUIDE FIBER OPTIC DIFFUSE TO INCLUDE USE OF A STERILE, SINGLE USE SHEATH WITH A REUSABLE DIFFUSING FIBER OPTIC.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM, SERIES DCYL 4 AND IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN(R) (PORFIMER SODIUM) FOR INJECTION FOR THE:  1) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER, OR OF PATIENTS WITH PARTIALLY OBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIANS, CANNOT BE SATISFACTORILY TREATED WITH ND:YAG LASER THERAPY, 2) REDUCTION OF OBSTTUCTION AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLY OBSTRUCTING ENDOBRONCHIAL NONSMALL CELL LUNG CANCER (NSCLC), 3) TREATMENT OF MICROINVASIVE ENDOBRONCHIAL NSCLC IN PATIENTS OF WHOM SURGERY AND RADIOTHERAPY ARE NOT INDICATED.
P950034|S015|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM(TM) BIORESORBABLE MEMBRANE|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2000|06/23/2000|||OK30|THE ELIMINATION OF ANNUAL LOT STABILITY TESTING FOR SEPRAFILM(TM) BIORESORBABLE MEMBRANE (SEPRAFILM(TM)).  THIS CHANGE WILL ELIMINATE THE ANNUAL LOT STABILITY TESTING REQUIREMENT, AND DECREASE THE QUANTITY OF THE PRODUCT USED FOR STABILITY LOT FAILURES DURING A TESTING PERIOD OF OVER THREE YEARS.
P860003|S036|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2000|11/22/2000|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT HARMAC MEDICAL PRODUCTS, CHEEKTOWAGA, NEW YORK.
P980001|S020|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2000|06/13/2000|||OK30|CHANGE IN MANUFACTURING PROCESS TO REMOVE TWO INSPECTION STEPS FOR MARKERBAND PLACEMENT ON THE NIR(TM) W/SOX(TM) PREMOUNTED STENT DELIVERY SYSTEM.
P950037|S014|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|ACTROS FAMILY OF PULSE GENERATORS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2000|06/20/2000|||OK30|CHANGE TO SMALLER BLISTER PACKAGING IN THE MANUFACTURING PROCESS OF ALL CURRENT AND FUTURE BIPOLAR PULSE GENERATOR FAMILIES.
P960004|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE II/ FINELINE II|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/2000|11/21/2000|||APPR|APPROVAL FOR THE SILICONE AND POLYURETHANE THINLINE(TM) II STEROX AND FINELINE(TM) II STEROID ELUTING PACING LEADS.  THE DEVICES ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE VENTRICLE AND/OR ATRIUM WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
P870018|S025|SIEMENS CORP.|186 WOOD AVE., SOUTH||ISELIN|NJ|08830||Lithotriptor, extracorporeal shock-wave,urological|LITHOSTAR MODULARIS|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/10/2000|07/17/2000|||APRL|APPROVAL FOR THE MOBILE CONFIGURATION OF THE LITHOSTAR MODULARIS.
P890003|S060|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SYNERGYST II PMA FAMILY OF IMPLANTABLE PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/2000|07/21/2000|||APPR|APPROVAL FOR THE USE OF HEADER PART NUMBER 149422-002 IN THE FOLLOWING PULSE GENERATORS: PREVAIL MODEL 8085, PREVA SR MODEL 8089, PRODIGY S MODEL 8165, PRODIGY SR MODEL 8161, THERA-I S MODEL 8965I, THERA-I SR MODEL 8961I, VITATRON VISA S MODEL 115, VITATRON VISA SR MODEL 415.
P950034|S016|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|Real-Time Process|Other Report|N|05/30/2000|07/07/2000|||APPR|APPROVAL FOR ELIMINATION OF THE RAT CECAL ABRASION BIOASSAY AS A FINISHED PRODUCT RELEASE CRITERION AND AS A STABILITY TEST.
P850035|S028|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF SPINAL FUSION STIMULATOR|LOE|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2000|06/23/2000|||APPR|APPROVAL FOR A CHANGE FROM A LITHIUM IODINE BATTERY (CRC 1935M) TO A LITHIUM MANGANESE BATTERY (RENATA, CR-2032AMT207-1) IN THE SPF(R) 2T, 4T AND XLIIB SPINAL FUSION STIMULATORS.
P970058|S008|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER M1000 SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2000|07/05/2000|||APPR|APPROVAL FOR THE ADDITION OF A NEW MASS MARKER.  THIS MARKER (A CIRCLE) IS INTENDED TO ENABLE THE USER OF THE IMAGECHECKER TO DIFFERENTIATE OBVIOUS MASSES FROM MORE SUBTLE MASSES THAT APPEAR IN ANALYZED MAMMOGRAMS.
P900056|S045|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTAGLIDE(TM) LUBRICANT|MCX|CV|30-Day Notice||N|05/18/2000|06/06/2000|||OK30|CHANGES IN THE MANUFACTURING PROCESS, REMOVING ONE OF THE STEPS FROM THE RELEASE CRITERIA FOR ROTAGLIDE(TM) LUBRICANT, TO MOVE THE PACKAGING INSPECTION AND REVIEW OF THE CERTIFICATE OF ANALYSIS FROM BOSTON SCIENTIFIC CORP. NORTHWEST TO BOSTON SCIENTIFIC CORP'S MARINA BAY DISTRIBUTION CENTER IN QUINCY, MASSECHUSETTS.
P900056|S046|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice||N|05/19/2000|06/13/2000|||OK30|ALTERNATE VENDOR FOR THE BAKE HYPO TUBES USED IN THE MANUFACTURING OF THE ROTABLATOR ROTALINK ADVANCER AND PASSIVATED AT THE VENDOR, AN ADDITIONAL MANUFACTURING STEP FOR THE COMPONENT.
P970020|S024|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX DUET (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/2000|06/23/2000|||APPR|APPROVAL FOR INCLUSION OF THE SIX-MONTH CLINICAL TRIAL DATA FROM THE DUET STUDY IN THE INSTRUCTIONS FOR USE (IFU) FOR THE ACS MULTI-LINK RX AND OTW DUET(TM) CORONARY STENT SYSTEMS.
P840001|S047|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/01/2000|02/21/2001|||APPR|APPROVAL FOR EXPANSION OF THE INDICATIONS FOR USE OF THE MEDTRONIC MODEL 7421 ITREL, 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION SYSTEMS.  THESE DEVICES ARE NOW INDICATED "AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BCK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME OR HERNIATED DISC, POST-LAMINECTOMY PAIN, MULTIPLE BACK OPERATIONS, UNSUCCESSFUL DISC SURGERY, DEGENERATIVE DISC DISEASE (DDD/HERNIATED DISC PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS, PERIPHERAL CAUSALGIA, EPIDURAL FIBROSIS, ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS, COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA".
P950001|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/31/2000|06/29/2000|||APPR|APPROVAL FOR CHANGES TO THE LEAD STABILIZER COMPONENT.
P970003|S026|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEURO CYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/01/2000|07/19/2000|||APPR|APPROVAL FOR THE MODEL 400S NCP TUNNELING TOOL (FOR USE WITH THE NCP SYSTEM).
N18286|S012|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM STERILE POWDER|LMF|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/08/1999|10/16/2000|00M-1616|11/15/2000|APPR|APPROVAL FOR THE ADDITION OF BONE HEMOSTASIS TO THE INDICATIONS FOR USE
P890017|S009|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLOON EXPANDABLE STENT|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/26/2000|07/11/2000|||APPR|APPROVAL FOR A REVISED INSTRUCTIONS FOR USE (IFU) FOR THE CORDIS PALMAZ(TM) BALLOON EXPANDABLE STENT.
P790005|S043|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2000|06/23/2000|||APPR|APPROVAL FOR A CHANGE FROM A LITHIUM IODINE BATTERY (CRC 1935M) TO A LITHIUM MANGANESE BATTERY (RENATA, CR-2032AMT207-1) IN THE OSTEOGEN BONE GROWTH STIMULATORS.
P960025|S005|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE WITH VSP SPINE SYSTEM|MCV|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/2000|09/08/2000|||APPR|APPROVAL FOR CHANGING THE MATERIAL OF THE I/F CAGE DEVICE COMPONENT FROM INJECTION MOLDED PEKEKK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70 TO INJECTION MOLDED PEEK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70.
P880086|S073|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/25/2000|06/26/2000|||APPR|APPROVAL FOR MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS
P880006|S032|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/25/2000|06/26/2000|||APPR|APPROVAL FOR MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS.
P830045|S070|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/25/2000|06/26/2000|||APPR|APPROVAL FOR MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS.
P950022|S009|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|VENTRITEX(R) TVL(R) LEAD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/08/2000|07/06/2000|||APPR|APPROVAL FOR THE TVL RIGHT VENTRICULAR (RV) LEAD MODELS RV06 AND RV07.
P960040|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/08/2000|08/04/2000|||APPR|APPROVAL FOR THE PULSE GENERATOR MODELS 1860 AND 1861, PULSE GENERATOR SOFTWARE VERSION 1.3, AND PROGRAM/RECORDER/MONITOR SOFTWARE MODEL 2844, VERSION 3.1.
P970035|S021|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S660 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2000|06/30/2000|||OK30|CHANGE IN THE FORMING STEP FROM A THREE-STEP PROCESS TO A TWO-STEP PROCESS.
P970010|S004|SYNTHES (USA)|1690 RUSSELL RD.|POST OFFICE BOX 1766|PAOLI|PA|19301||BONE CEMENT|NORIAN SRS BONE CEMENT|LOD|PM|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/06/2000|08/31/2000|||APPR|APPROVAL FOR CHANGING THE VOLUME OF MATERIAL USED IN THE POST-APPROVAL RABBIT STUDY.
P810002|S052|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MASTERS SERIES VALVE: PTFE SEWING CUFF|LWQ|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|05/22/2000|06/30/2000|||APPR|APPROVAL TO REMOVE THE CONDITION OF APPROVAL IN THE JULY 23,1998 APPROVAL ORDER THAT THE FIRM PROVIDE RESULTS FROM TESTS WHICH DEMONSTRATE THE LONG-TERM INTEGRITY OF THE SEWING CUFF ATTACHMENT MECHANISM OF THE ST. JUDE MEDICAL(R) MASTER SERIES VALVE MODELS.
P910030|S009|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||STENT, CORONARY|GIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2000|02/13/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK, INC., BLOOMINGTON, INDIANA.  PACKAGING OF THE DEVICES WILL TAKE PLACE AT THIS FACILITY.
P850049|S008|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER|DTK|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2000|02/13/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK INC., BLOOMINGTON, INDIANA.
P880098|S011|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lens, contact (other material) - daily|MENICON SF-P (TM)|HQD|OP|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/13/2000|09/06/2000|||APPR|APPROVAL OF PROCEDURES TO ADD LENS FINISHING LABORATORIES AS MANUFACTURERS AND DISTRIBUTORS OF CLASS III RGP EXTENDED WEAR CONTACT LENSES.
P780012|S009|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|ABBOTT AXSYM HAVAB 2.0|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2000|02/02/2004|||APPR|APPROVAL FOR THE ABBOTT AXSYM HAVAB 2.0.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT AXSYM HAVAB 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODY TO HEPATITIS A VIRUS (ANTI-HAV) IN HUMAN SERUM OR PLASMA.  A TEST FOR ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION.
P910023|S047|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Panel Track|Change Design/Components/Specifications/Material|N|06/14/2000|10/27/2000|01M-0041|01/29/2001|APPR|APPROVAL FOR THE PHOTON(TM) DR ICD SYSTEM PROGRAMMER SOFTWARE, MODEL AC-IP IS-1 RECEPTABLE PLUG, AND MODEL 442-2 TORQUE DRIVER/TORQUE WRENCH.  THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A HISTORY OF HEMODYNAMICALLY COMPROMISING VENTRICULAR TACHYARRHYTHMIAS.  THESE PATIENTS MAY HAVE EXPERIENCED A CARDIAC ARREST NOT ASSOCIATED WITH ACUTE MYOCARDIAL INFARCTION OR HAVE VENTRICULAR TACHYARRHYTHMIAS.  IN ADDITION, THE PULSE GENERATOR CAN BE USED IN PATIENTS WHOSE PRIMARY THERAPY FOR HEMODYNAMICALLY SIGNIFICANT, SUSTAINED VENTRICULAR TACHYCARDIA IS ANTITACHYCARDIA PACING; THE DEFIBRILLATION CAPABILITIES OF THE DEVICE PROVIDE HIGH-ENERGY THERAPY IN THE EVENT THAT THE ARRHYTHMIA ACCELERATES.  THE PULSE GENERATOR CAN BE IMPLANTED IN EITHER THE PECTORAL REGION OR THE ABDOMINAL REGION, AT THE PHYSICIAN'S DISCRETION.
P910071|S005|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OIL 5000 SILICONE OIL|LWL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/2000|03/22/2001|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:  1) CHANGE OF MANUFACTURING SITE TO PHARM PUR GMBH, AUGSBURG, GERMANY  2) SPECIFICATION REVISIONS: A) CHANGE TO THE FOLLWOING SPECIFICATIONS: VISCOSITY; RESISTIVITY; AND CONTEND OF OLIGOSILOXANES; AND B) ADDITION OF THE FOLLOWING SPECIFICATIONS AND THEIR TEST METHODS; CONTENT OF CATALYST; HEAVY METALS; ENDOTOXINS; ACID CONTENT; CYTOTOXIDITY AND ACETONE  3) CHANGE IN THE FOLLOWING METHOD: DETERMINATION OF CONTENT OF OH-END GROUPS (CHANGED FROM HNMR TO KARL FISHER TITRATION).
P900056|S047|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2000|07/11/2000|||APPR|APPROVAL FOR A QUALITY CONTROL CHANGE TO ENSURE ADEQUATE INSPECTION OF GUIDE WIRES FOR THE APPROPRIATE APPLICATION OF LUBRICANT.
P980050|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF SYSTEM|LWS|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/15/2000|04/06/2001|01M-0254|06/06/2001|APPR|APPROVAL FOR THE MEDTRONIC(R) MODEL 7250 JEWEL(R) AF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM, MEDTRONIC MODEL 9465 INCHECK(TM) PATIENTS ASSISTANT AND THE MEDTRONIC TRANSVENE(R) CS/SVC MODEL 6937A LEAD.  THE SYSTEM IS INTENDED TO PROVIDE PACING, CARDIOVERSION AND DEFIBRILLATION FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC DRUG REFRACTORY ATRIAL FIBRILLATION AND/OR LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS.
P920014|S012|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE IP & VE LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/15/2000|06/23/2000|||APPR|APPROVAL FOR OUTFLOW GRAFT BEND RELIEF (OGER) AND FOR A MODIFICATION TO THE STAND ALONE OUTFLOW GRAFT.
P900056|S048|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTALINK|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2000|07/21/2000|||APPR|APPROVAL FOR THE USE OF A MODIFIED FORMED CATHETER TUBE IN THE RATABLATOR(R) ROTALINK SYSTEM.
P950008|S001|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2000|07/11/2000|||APPR|APPROVAL FOR A MODIFICATION TO THE MOLECULAR WEIGHT SPECIFICATION RANGE FROM 38,000-48,000 DALTONS TO 36,000-48,000 DALTONS.
P970004|S010|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION SYSTEM|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2000|06/28/2000|||APPR|APPROVAL FOR 1) INCLUSION OF DEPTH INDICATORS ALONG THE BODY OF THE MODEL 3057 TEST STIMULATION LEAD AND ASSOCIATED LABELING CHANGES (3057 TEST STIMULATION COMPONENTS MANUAL AND 3065U MANUAL), AND 2) OTHER MINOR LABELING CHANGES TO THESE MANUALS FOR CLARIFICATION OF INSTRUCTIONS AND MINOR REFINEMENTS TO THE LEAD TESTING SPECIFICATIONS.
P920015|S017|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO MODEL 6944 LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2000|12/15/2000|||APPR|APPROVAL FOR THE MEDTRONIC(R) SPRINT(TM) QUATTRO(TM) MODEL 6944 LEAD WHICH IS INTENDED FOR SINGLE LONG-TERM USE IN THE RIGHT VENTRICLE.  THIS LEAD HAS APPLICATION FOR PATIENTS IN WHICH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS ARE INDICATED.
P910018|S005|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2000|12/06/2000|||APPR|APPROVAL FOR 1) REPLACING THE STERILIZATION DATE WITH THE ACTUAL EXPIRATION DATE, EXPRESSED AS MONTH AND YEAR, FOR THE LIPOSORBER(R) LA-15 SYSTEM COMPONENTS:  LIPOSORBER(R) LA-15 COLUMN, SULFLUX(R) FS-05 PLASMA SEPARATOR, AND THE TUBING SYTEM FOR PLASMAPHERESIS LT-MA2; 2) REPLACING THE SLIP-TYPE MALE TUBING CONNECTORS WITH LUER-LOCK TYPE CONNECTORS ON THE SEPARATOR END-CAPS OF TE SULFLUX FS-05 PLASMA SEPARATOR;  3) MAKING THE FOLLOWING CHANGES TO THE TUBING SYSTEM FOR THE PLASMAPHERESIS LT-MA2: A) PROVIDING STERILE TRANSDUCER PROTECTIVE FILTERS (FOUND SUBSTANTIALLY EQUIVALENT UNDER 510(K) K983076) IN PACKAGES OF TEN; B) REDUCING THE NUMBER OF CONNECTION TUBES FROM TEN TO EIGHT, ADDING PINCH CLIPS AND REDUCING THE SHARPNESS OF THE PLASTIC SPIKE ON EACH END OF THE CONNECTION TUBE; C) REPLACING THE STAINLESS STEEL NEEDLES, USED TO CONNECT EACH INFUSION LINE TO A BAG OR BOTTLE OF SALINE OR REGENERATION FLUID, WITH PLASTIC SPIKES; D) ADDING A LUER-LOCK "MALE" AND "FEMALE" CONNECTOR TO THE END OF THE WASTE LINES; E) INCREASING THE LENGTH OF THE TUBING SECTION BETWEEN THE BLOOD PUMP AND CHANBER LEVEL 1 FROM 80 MM TO 90 MM AND THE LENGTH OF THE TUBING SECTION BETWEEN THE WASTE DRIP CHAMBER AND A "T" DCONNECTOR ON THE WASTE LINE FROM 35 M TO 50 MM; AND F) ADDING AN INFUSION LINE.
P860019|S164|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2000|06/29/2000|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION FCILITY AT IBA (FORMERLY GRIFFITH MICRO SCIENCE, INC.), WILLOWBROOK, ILLINOIS 60521.
P960058|S014|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/22/2000|11/15/2000|||APPR|APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR PEDIATRIC USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE AND IS INDICATED FOR SEVERELY AND PROFOUNDLY HEARING IMPAIRED CHILDREN AGES 18-MONTHS TO 17-YEARS.
P880081|S026|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|PHACOFLEX II(R) SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/2000|11/20/2000|||APPR|APPROVAL FOR ADDITIONAL LABELING STATEMENTS.
P960057|S011|WRIGHTMEDICALTECHNOLOGYINC|5677 AIRLINE RD.||ARLINTON|TN|38002||INHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER)|ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL|MLQ|PM|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2000|09/27/2000|||APPR|APPROVAL FOR MODIFICATIONS TO PROCEDURES USED FOR THE MANUFACTURE AND TESTING OF THE DEVICE.  THE DEVICE IS INDICATED FOR USE DURING SINGLE LEVEL, POSTERIOR LUMBAR LAMINECTOMY OR LAMINOTOMY PROCEDURES WHERE NERVE ROOTS ARE EXPOSED TO INHIBIT POSTSURGICAL PERIDURAL FIBROSIS.
P910073|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2000|10/05/2000|||APPR|APPROVAL FOR THE ENDOTAK FAMILY OF DEFIBRILLATION LEADS AND THE ACCESSORY STYLET KIT.
P940008|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||LEAD CAP ACCESSORY KIT||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2000|10/05/2000|||APPR|APPROVAL FOR THE LEAD CAPS FOR USE WITH ALL GUIDANT COMPATIBLE LEADS INCLUDING THE RELIANCE(TM) AND RELIANCE S(TM) LEADS.
P990035|S001|BEAM-MED LTD|8 HALAPID STR.||PETACH TIKVA||49170||Bone sonometer|OMNISENSE 7000S ULTRASOUND BONE SONOMETER|MUA|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/2000|06/21/2001|||APPR|APPROVAL FOR THE ADDITION OF TWO NEW PROBES FOR USE ON TWO ADDITIONAL SKELETAL SITES, THE PROXIMAL THIRD PHALANX AND THE FIFTH METATARSAL.  THE DEVICE, AS MODIFIED, IS INDICATED AS FOLLOWS:  "A NONINVASIVE DEVICE THAT IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF THE SIGNAL VELOCITY OF ULTRASONIC WAVES ("SPEED OF SOUND" OR "SOS" IN M/SEC) PROPAGATING AT MULTIPLE SKELETAL SITES (I.E., THE DISTAL ONE-THIRD OF THE RADIUS, THE PROXIMAL THIRD PHALANX, AND THE FIFTH METATARSAL).  SOS PROVIDES AN ESTIMATE OF SKELETAL FRAGILITY.  THE OUTPUT IS ALSO EXPRESSED AS A T-SCORE AND A Z-SCORE, AND CAN BE USED IN CONJUNCTION WITH OTHER CLINICAL RISK FACTORS AS AN AID TO THE PHYSICIAN IN THE DIAGNOSIS OF OSTEOPOROSIS AND OTHER MEDICAL CONDITIONS LEADING TO REDUCED BONE STRENGTH AND, ULTIMATELY , IN THE DETERMINATION OF FRACTURE RISK.  MULTIPLE SKELETAL SITE TESTING PROVIDES CLINICIANS WITH ALTERNATIVES IF ONE SITE IS NOT ACCESSIBLE AND WITH ADDITIONAL SKELETAL INFORMATION (I.E., FROM BONES WITH DIFFERENT COMBINATIONS OF CORTICAL AND CANCELLOUS MATERIAL AND FROM WEIGHT BEARING AND NON-WEIGHT BEARING SITES) THAT ASSISTS IN DIAGNOSING OSTEOPOROSIS AND RISK FRACTURE.  THE SOS MEASUREMENT BY OMNISENSE HAS A PRECISION ERROR LOW ENOUGH IN COMPARISON WITH THE EXPECTED ANNUAL CHANGE IN A PATIENT'S MEASUREMENT TO MAKE IT SUITABLE FOR MONITORING BONE CHANGES WHICH OCCUR IN THE EARLY YEARS FOLLOWING MENOPAUSE (I.E., AGE RANGE APPROXIMATELY 50-65 YEARS)."
P930038|S026|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR DEVICE - 8F AND 6F|MGB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2000|11/29/2000|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT ST. JUDE MEDICAL, PUERTO RICO, CAGUAS, PUERTO RICO.
P850051|S055|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|8085 PREVAIL IMPLANTABLE PULSE GENERATOR|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/2000|07/21/2000|||APPR|APPROVAL FOR THE USE OF HEADER PART NUMBER 149422-002 IN THE FOLLOWING PULSE GENERATORS: PREVAIL MODEL 8085, PREVA SR MODEL 8089, PRODIGY S MODEL 8165, PRODIGY SR MODEL 8161, THERA-I S MODEL 8965I, THERA-I SR MODEL 8961I, VITATRON VISA S MODEL 115 AND VITATRON VISA SR MODEL 415.
P990071|S001|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|STOCKERT 70 RF GENERATOR AND ACCESSORIES/INTERFACE CABLE|DRF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2000|07/21/2000|||APPR|APPROVAL FOR A CHANGE IN MANUFACTURING FACILITY ADDRESS TO STOCKERT GMBH, FREIBURG, GERMANY.
P930029|S014|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR(R) RFCA ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/28/2000|07/31/2000|||APPR|APPROVAL FOR A MODIFICATION TO THE TIP ELECTRODE LENGTH (5 MM).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONDUCTR(R) MC-5MM, AND IS INDICATED FOR THE INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA, FOR THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA, AND FOR CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P900056|S049|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2000|07/27/2000|||APPR|APPROVAL FOR A QUALITY CONTROL CHANGE TO THE STEPS INVOLVED IN INSTALLATION AND INSPECTION OF THE INFUSION HOSE.
P900056|S050|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2000|07/24/2000|||OK30|CHANGE IN THE GOLD STRIPPING PROCESS.  THE STRIPPING CYCLE WILL NOW BE REPEATED WHEN A VISUAL INSPECTION INDICATES THAT GOLD PARTICULES REMAIN ON THE WIRE.
P960040|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK(R) PRIZM(TM) DR/VR HE SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2000|08/07/2000|||APPR|APPROVAL FOR THE HIGH ENERGY AUTOMATIC IMPLANTABLE CARDIOVASCULAR DEFIBRILLATOR (AICD) SYSTEM, MODELS 1852, 1853, 1857, AND 1858.
P980001|S021|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR(R) PREMOUNTER STENT SYSTEMS||CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2000|07/14/2000|||APPR|APPROVAL FOR AN ALTERNATE CONTRACT STERILIZATION FACILITY LOCATED AT IBA (FORMERLY GRIFFITH MICRO SCIENCE, INC.), WILLOWBROOK, ILLINOIS.
P900056|S051|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2000|07/24/2000|||OK30|ALTERNATE VENDOR FOR THE LARGE FRONT AND FRONT INSERT HYPO TUBES USED IN THE MANUFACTURE OF THE ADVANCER.
P900056|S052|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2000|07/27/2000|||APPR|APPROVAL FOR A QUALITY CONTROL CHANGE TO ADD A PACKAGE LABEL VERIFICATION STEP AT GUIDE WIRE PACKAGING.
P960043|S025|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||CLOSER (TM) SUTURE MEDIATED CLOSURE DEVICE||CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2000|08/03/2000|||APPR|APPROVAL FOR A MANUFACTURING MODIFICATION TO THE FOOT COMPONENT OF THE CLOSER(TM) SMC DEVICE.
P980049|S002|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140|||ORCHESTRA PROGRAMMER||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/2000|11/13/2000|||APPR|APPROVAL FOR ORCHESTRA PROGRAMMER WITH THE FOLLOWING APPLICATION SOFTWARE PACKAGES: MANAGER SOFTWARE APPLICATION VERSION 1.02, CSO A PROGRAMMER APPLICATION VERSION 2.21, CSO-WINDOWS PROGRAMMER APPLICATION VERSION 1.03, DEFENDER II PROGRAMMER APPLICATION VERSION 2.03, AND DEFENDER IV PROGRAMMER APPLICATION VERSION 1.03.
P860003|S037|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS(TM) PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/07/2000|01/05/2001|||APPR|APPROVAL FOR THE FOLLOWING SOFTWARE CHANGES:  1) REMOVAL OF SYSTEM ERROR F522:0000,  2) REMOVAL OF SYSTEM ERROR F581:0000,  3) CHANGE IN THE ALARM THRESHOLD FOR THE CENTRIFUGE BOWL VACUUM, AND  4) ADDITION OF NEW PRIMING STATE.
P970034|S007|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|PC-IOL|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2000|01/17/2001|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT OPHTHALMIC INNOVATIONS INTERNATIONAL, INC., ONTARIO, CALIFORNIA.
P790019|S011|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|ABBOTT AXSYM HAVAB-M 2.0|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2000|02/02/2004|||APPR|APPROVAL FOR THE ABBOTT AXSYM HAVAB-M 2.0.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AXSYM HAVAB-M 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION IF IGM ANTIBODY TO HEPATITIS A VIRUS (IGM ANTI-HAV) IN HUMAN SERUM OR PLASMA.  A TEST FOR IGM ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS A VIRAL INFECTION.
P900043|S025|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY(TM) STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2000|02/02/2001|||APPR|APPROVAL FOR A NEW INDICATION (I.E., DE NOVO AND RESTENOTIC LESIONS) AND ADDITIONAL STENT DIAMETERS (I.E., 4.5 AND 5.0 MM) FOR THE BX VELOCITY(TM) STENT WITH RAPTOR(TM) OVER-THE-WIRE DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<=30 MM INLENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM; AND   2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM.  THE 2.25 MM, 2.5 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
P940004|S001|VENTANA MEDICAL SYSTEMS, INC.|1910 EAST INNOVATION PARK DR.||TUCSON|AZ|85755||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|INFORM HER-2/NEU|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2000|08/01/2000|||OK30|RAW MATERIAL SUBSTITUTION OF REPLACING NONIDET P-40, RAW MATERIAL WITH IGEPAL CA-630, AND CHANGES FOR THE USE OF DRY POWDERS OR SOLUTIONS THAT ARE PURCHASED RATHER THAN MANUFACTURED WHILE KEEPING THE FINAL FORMULATION AND SPECIFICATIONS THE SAME.
P950035|S008|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM|GZC|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2000|11/14/2000|||APPR|APPROVAL FOR  1) CHANGING THE MANUFACTURING SITE FOR THE FREEHAND IMPLANTABLE RECEIVER-STIMULATOR TO LEWICKI MICROELECTRONIC, GMBH;  2) ADDITION OF A RADIOGRAPHIC IDENTIFICATION LABEL TO THE IMPLANTABLE RECEIVER-STIMULATOR; AND  3) IMPLEMENTING SEVERAL DESIGN MODIFICATIONS INVOLVING THE ENCAPSULATING MATERIAL AND CIRCUITRY OF THE FREEHAND IMPLANTABLE RECEIVER-STIMULATOR.
P910073|S033|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2000|09/12/2000|||APPR|APPROVAL FOR INTERNAL COMPONENT CHANGES TO THE IS-1 CONNECTOR TERMINAL OF THE MODEL 6952 LEAD EXTENDER.
P980008|S002|LASERSIGHT TECHNOLOGIES, INC.|6903 UNIVERSITY BLVD.,||WINTER PARK|FL|32792||Excimer laser system|LASERSCAN LSX EXCIMER LASER|LZS|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2000|10/27/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT LASERSIGHT TECHNOLOGIES, INC., WINTER PARK, FLORIDA.
P870056|S014|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2000|08/04/2000|||OK30|CHANGE IN VENDOR SUPPLIER FOR THE MATERIAL IDENTIFIED AS POLYESTER USED IN THE MANUFACTURE OF THE BIOPROSTHESIS.
P870077|S012|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2000|08/04/2000|||OK30|CHANGE IN VENDOR SUPPLIER FOR THE MATERIAL IDENTIFIED AS POLYESTER USED IN THE MANUFACTURE OF THE BIOPROSTHESIS.
P860057|S014|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2000|08/04/2000|||OK30|CHANGE IN VENDOR SUPPLIER FOR THE MATERIAL IDENTIFIED AS POLYESTER USED IN THE MANUFACTURE OF THE HEART VALVE.
P980001|S022|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIROYAL(TM) ELITE OVER-THE-WIRE(OTW) STENT SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/2000|02/16/2001|||APPR|APPROVAL FOR THE NIROYAL(TM) ELITE OTW STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS IN NATIVE CORONARY ARTERIES (LENTH <=25 MM) IN REFERENCE VESSEL DIAMETER 3.0 TO 4.0 MM;  2) TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND  3) PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS WITH LESION LENGTH <=30 MM AND REFERENCE DIAMETER IN THE RANGE OF 3.0 TO 4.0 MM.
P790017|S072|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER|LOX|CV|30-Day Notice||N|07/14/2000|07/24/2000|||OK30|CHANGE IN SUPPLIER OF THE HIGH MOLECULAR WEIGHT HIGH-DENSITY POLYETHYLENE INNER SHAFT USED IN AVE IRELAND'S MANUFACTURING NEPTUNE(TM) X-ACT(R) AND D114S OVER-THE-WIRE PTCA CATHETERS OPERATIONS.
P930016|S012|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|07/14/2000|04/27/2001|01M-0305|07/23/2001|APPR|APPROVAL FOR THE VISX STAR S2 AND S3 EXCIMER LASER SYSTEMS.  THE DEVICES ARE INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS:  1) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE  EXAMINATION; AND  2) IN PATIENTS 21 YEARS OF AGE OR OLDER IN TREATMENTS FOR THE REDUCTION OF ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +05 AND +5.0 D SPHERE AT THE SPECTACLE PLANE WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO +3.0 D, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D.
P970061|S009|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT||CV|Normal 180 Day Track|Express GMP Supplement|N|07/17/2000|08/22/2000|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC/SCIMED, INC., PLYMOUTH, MINNESOTA 55442 AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA, WILLOWBROOK, ILLINOIS 60521.
P870015|S036|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotriptor, extracorporeal shock-wave,urological|TRANSPORTABLE MODEL STS-T LITHOTRIPTER|LNS|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/2000|07/26/2000|||APRL|APPROVAL FOR MINOR SOFTWARE UPGRADES (VERSION 2000.0) AND ASSOCIATED CHANGES TO THE DEVICE LABELING.
P880086|S075|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFFINITY PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/01/2000|08/15/2000|||APPR|APPROVAL FOR REMOVAL OF THE PARYLENE COATING FROM THE AFFINITY MODELS DR 5330, SR 5130, DC 5230, ENTITY DR 5326, AND ENTITY DC 5226 PULSE GENERATORS.
P880086|S076|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AV PLUS DX MODEL 1368 LEAD|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/01/2000|08/25/2000|||APPR|APPROVAL FOR AN ADDITIONAL LEAD LENGTH OF 65 CM.
P980008|S003|LASERSIGHT TECHNOLOGIES, INC.|6903 UNIVERSITY BLVD.,||WINTER PARK|FL|32792||Excimer laser system|LASER SCAN LSX EXCIMER LASER|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/2000|08/15/2000|||APPR|APPROVAL FOR A CHANGE IN THE LASER PULSE REPETITION RATE FROM 100 TO 200 HZ.
P970051|S011|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/2000|11/01/2000|||APPR|MODIFICATION OF THE ELECTRODE FOR THE NUCLEUS CI24 COCHLEAR IMPLANT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM WITH THE FOLLOWING CHANGES TO THE INDICATIONS FOR USE:  1) APPROVAL TO IMPLANT INDIVIDUALS, AGE 18 YEARS AND OLDER, WHO OBTAIN LIMITED BENEFIT FROM AMPLIFICATION AS DEFINED BY TEST SCORES OF <=50% CORRECT IN THE EAR TO BE IMPLANTED, (<=60% IN THE BEST AIDED LISTENING CONDITION) ON TAPE RECORDED TESTS OF OPEN SET SENTENCE RECOGNITION.  2) APPROVAL TO IMPLANT CHILDREN 12 MONTHS OF AGE AND OLDER WHO HAVE BILATERAL PROFOUND SENSORINEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.
P950029|S010|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|TALENT AND BRIO PACEMAKERS (RIGID CONNECTOR)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2000|10/10/2000|||APPR|APPROVAL TO CHANGE THE HEADER MATERIAL IN THE TALENT AND BRIO PACEMAKERS FROM SILICONE RUBBER TO TECOTHANE 75D POLYURETHANE
P950029|S011|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|ELA RATE-RESPONSIVE PACEMAKERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/2000|10/11/2000|||APPR|APPROVAL IS FOR THE FOLLOWING MODIFICATIONS TO YOUR BRIO FAMILY OF PACEMAKERS:  1) MODIFY THE VALUE FOR THE NUMBER OF CYCLES THE DEVICE WILL ALLOW BEFORE A SELF TEST IS INITIATED WHEN THE SENSOR "CALLS FOR AN ELEVATED PACING RATE FOR A DURATION OR FREQUENCY THAT EXCEES REASONABLE PHYSIOLOGIC LIMITS" FROM 30,000 TO 100,000 CYCLES; AND2)  CHANGING THE MINIMUM SENSING THRESHOLD DURING T-WAVE PROTECTION FROM 2.2 TO 2.5MV.
P950029|S012|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|ELA RATE-RESPONSIVE PACEMAKERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/14/2000|09/13/2000|||APPR|APPROVAL FOR CHANGES TO THE IMPLANT AND PROGRAMMER SOFTWARE FOR THE TALENT AND BRIO FAMILIES OF PACEMAKERS.
P950037|S015|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/07/2000|09/05/2000|||APPR|APPROVAL FOR THE ACTIVATION OF THE PMT MANAGEMENT AND AV DELAY FEATURES IN THE PHILOS PULSE GENERATOR FAMILY, MODIFICATIONS TO THE PROGRAMMER SOFTWARE RESULTING IN VERSION B-K01.0.U, THE PGH 3000 PROGRAMMER HEAD, AND THE VK-92 PROGRAMMER PRINTER CABLE.
P990013|S001|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2000|09/25/2000|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY AT STAAR SURGICAL CO., MONROVIA, CALIFORNIA.
P960040|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV DDD/AV II DDDD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/2000|12/13/2000|||APPR|APPROVAL FOR THE VENTAK(R) AV DDD/ AV II DDD MODEL 2833 VERSION 4.0 SOFTWARE, THE VENTAK(R) VR MODEL 2841 VERSION 4.0 SOFTWARE AND THE DELTA(R)/ VISTA(R) MODEL 2881 VERSION 2.0 SOFTWARE.
P840068|S040|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA/VISTA|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/2000|12/13/2000|||APPR|APPROVAL FOR THE VENTAK(R) AV DDD/ AV II DDD MODEL 2833 VERSION 4.0 SOFTWARE, THE VENTAK(R) VR MODEL 2841 VERSION 4.0 SOFTWARE AND THE DELTA(R)/ VISTA MODEL 2881 VERSION 2.0 SOFTWARE.
P930021|S005|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN GEL|NQA|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/2000|06/04/2002|||APPR|APPROVAL FOR THE REVISIONS TO THE PACKAGE INSERT AS LISTED BELOW BASED ON NEW DATA THAT HAS BEEN PRESENTED IN THIS PMA SUPPLEMENT.  1) INCLUSION OF THE FOLLOWING STATEMENT IN THE CLINICAL CONSIDERATIONS SECTION:  "HISTOLOGICAL STUDIES HAVE DEMONSTRATED RESULTS RANGING FROM COMPLETE PERIODONTAL REGENERATION (NEWLY FORMED CEMENTUM, PERIODONTAL LIGAMENT, AND ALVEOLAR BONE) TO REPAIR INCLUDING NEW CONNECTIVE TISSUE ATTACHMENT (CONNECTIVE TISSUE ADAPTATION VIA NEW CEMENTUM) AND A NEW ATTACHMENT MEDIATED BY AN EPITHELIAL ATTACHMENT (LONG JUNCTIONAL EPITHELIUM).  THE LONG-TERM STABILITY OF THE REGENERATED TISSUE HAS NOT BEEN ESTABLISHED.  AS IN ANY PERIODONTAL SURGICAL THERAPY, DEFECT MORPHOLOGY, SURGICAL TECHNIQUE AND HOST RESPONSE ARE IMPORTANT PARAMETERS FOR SUCCESSFUL OUTCOMES."  2) INCLUSION OF THE FOLLOWING STATEMENTS IN THE CLINICAL CONSIDERATIONS SECTION: A) PATIENTS TEND TO REPORT LESS POST-SURGICAL DISCOMFORT; B) CLINICIANS HAVE REPORTED ON ENHANCED WOUND HEALING.
P940040|S001|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST|MWA|MI|Normal 180 Day Track||N|07/26/2000|09/12/2000|||APPR|APPROVAL FOR CURRENT FACILITY PLANS, REVISED BATCH RECORDS, REVISED QC SPECIFICATIONS, REVISED PACKAGING ORDERS AND REVISED LABELS.
P990028|S001|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Mesh, surgical, polymeric|FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT|FTL|AN|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/28/2000|04/20/2001|||APPR|APPROVAL FOR THE POST APPROVAL STUDY PROTOCOL PMS-0001-0.
P990066|S001|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2000|11/13/2000|||APPR|APPROVAL FOR USE OF THE REVIEW WORKSTATION FOR FINAL INTERPRETATION OF EXAMINATIONS.
P950021|S002|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY|LTJ|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/2000|12/22/2000|01M-0038|02/07/2001|APPR|APPROVAL FOR THE ACS:180 AND ADVIA CENTAUR IMMUNOASSAY ANALYZERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ACS:180 PSA IMMUNOASSAY AND ADVIA CENTAUR PSA IMMUNOASSAY AND IS INDICATED FOR THE FOLLOWING:  THE BAYER ACS:180(TM) AND ADVIA CENTAUR(TM) PSA ASSAYS ARE IN VITRO DEVICES INTENDED FORO THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM.  THESE DEVICES ARE INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THESE DEVICES ARE FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
P990064|S001|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705|||MOSAIC PORCINE BIOPROSTHESIS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2000|08/29/2000|||OK30|CHANGE IN THE METHOD IN WHICH A RAW MATERIAL (AOA COMPOUND) IS SYNTHESIZED.  THIS WILL RESULT IN THE RAW MATERIAL BEING RECEIVED IN A MORE PURIFIED FORM.  IN ADDITION, THE QUALITY CONTROL TEST PERFORMED ON INCOMING INSPECTION WILL CHANGE FROM THE GRAVIMETRIC TEST METHOD TO THE NINHYDRIN TEST METHOD.
P950005|S009|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CORDIS WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2000|09/29/2000|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., IRWINDALE, CALIFORNIA.
P990025|S001|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2000|09/28/2000|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC. ,IRWINDALE, CALIFORNIA.
P990064|S002|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705|||MOSAIC PORCINE BIOPROSTHESIS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2000|08/29/2000|||OK30|CHANGE IN THE VENDOR OF THE POLYESTER YARN USED IN THE MANUFACTURE OF THE MOSAIC PORCINE BIOPROSTHESIS.  ALSO, INCLUSION OF THE PMA PRODUCT IN THE "MASTER SUBMISSION" SUBMITTED APRIL 3, 1998 TO P970031/S006 FREESTYLE AORTIC BIOPROSTHESIS.  THE INFORMATION CONTAINED IN THE "MASTER SUBMISSION" IS DIRECTLY APPLICABLE TO THE POLYESTER YARN VENDOR CHANGE.
P990018|S001|MENICON CO. LTD.|269 A BALLARDVALE STREET||WILMINGTON|MA|01887||Lens,contact(rigid gas permeable)-extended wear|MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS|MWL|OP|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/28/2000|09/06/2000|||APPR|APPROVAL OF PROCEDURES TO ADD LENS FINISHING LABORATORIES AS MANUFACTURERS AND DISTRIBUTORS OF CLASS III RGP EXTENDED WEAR CONTACT LENSES.
P980001|S023|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIROYAL(R) ELITE PREMOUNTED STENT SYSTEM||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/2000|01/25/2001|||APPR|APPROVAL FOR ADDITIONAL STENT LENGTHS (I.E., 9 MM, 12 MM AND 18 MM) FOR THE NIROYAL(TM) ELITE PREMOUNTED STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYNPTOMATIC ISCHEMIC DISEASE ASSOCIATED WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <=25 MM) IN REFERENCE VESSEL DIAMETER OF 3.0 TO 4.0 MM;  2) TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND  3) PATIENTS WITH SYNPTOMATIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS WITH LESION LENGTH <=30 MM AND REFERENCE DIAMETER IN THE RANGE OF 3.0 TO 4.0 MM.
P980001|S024|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR ELITE MONORAIL AND OVER-THE-WIRE(OTW) STENT SYSTEMS||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/2000|02/16/2001|||APPR|APPROVAL FOR THE NIR(TM) ELITE MONORAIL AND OTW STENT SYSTEMS.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE ASSOCIATED WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <=25 MM) IN REFERENCE VESSEL DIAMETER OF 3.0 TO 4.0 MM;  2) TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 TO 4.0 MM; AND  3) PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS WITH LESION LENGTH <=30 MM AND REFERENCE DIAMETER IN THE RANGE OF 3.0 TO 4.0 MM.
P900009|S011|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM|LPQ|OR|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/11/2000|09/08/2000|||APPR|APPROVAL FOR A CHANGE IN THE CONDITIONS OF APPROVAL TO TERMINATE THE REQUIREMENT FOR A PRESCRIPTION REGISTRY.
P890003|S061|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC 9790/9790C PROGRAMMER|DXY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/02/2000|10/02/2000|||APPR|APPROVAL FOR MODIFICATION OF LABELING REGARDING THE VGA VIDEO OUTPUT PORT ON THE MODEL 9790/9790C SERIES PROGRAMMERS, WHICH INSTRUCTS USERS TO CONTACT MEDTRONIC TECHNICAL SERVICES FOR GUIDANCE IN USING THE PORT.
P810002|S053|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2000|11/21/2000|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE ORIFICE GRAPHITE SUBSTRATE.
P960036|S002|IOLTECH, S.A.|64 SCHOOSETT STREET||PENBROKE|MA|02359|1882|intraocular lens|MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track||N|07/17/2000|08/25/2000|||APPR|APPROVAL FOR THE MANUFACTURING CHANGES THAT WERE IMPLEMENTED AS A RESULT OF THE VOLUNTARY RECALL.
P970021|S004|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|THERMA CHOICE UTERINE BALLON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2000|02/13/2001|||APPR|APPROVAL TO TRANSFER THE THERMACHOICE CATHETER MANUFACTURING OPERATIONS TO A NEW MANUFACTURING FACILITY LOCATED AT ETHICON, INC., CHIHUAHUA, MEXICO.
P910018|S006|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER(R) LA-15 SYSTEM|MMY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2000|08/21/2000|||OK30|CHANGE IN THE STERILIZATION PROCESS EQUIPMENT FOR THE PLASMAPHERESIS(R) LT-MA2 TUBING SYSTEM THAT IS USED WITH THE LIPOSORBER(R) LA-15 SYSTEM.
P900060|S021|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2000|09/05/2000|||OK30|CHANGE TO A LARGER CAPACITY CHAMBER USED TO STERILIZE THE SULZER CARBOMEDICS CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS.  THIS LARGER CAPACITY CHAMBER IS LOCATED AT THE FACILITY IDENTIFIED AS SULZER VASCUTEK LOCATED IN SCOTLAND.
P970003|S027|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS(NCP(R)) SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2000|08/24/2000|||OK30|CHANGE IN THE STERILIZATION LOAD CONFIGURATION FROM USING A 3-TOTE LOAD TO A 12-TOTE LOAD.
P970018|S001|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|AUTOCYTE PREP SYSTEM|MKQ|PA|Real-Time Process|Postapproval Study Protocol - ODE/OIR|N|08/08/2000|08/29/2000|||APPR|APPROVAL FOR THE PROTOCOL FOR THE AUTOCYTE PREP POST-APPROVAL STUDY.
P950032|S018|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF(R)|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2000|08/31/2000|||APPR|APPROVAL TO INTRODUCE NEW CELL STRAINS INTO THE PRODUCTION OF APLIGRAF (I.E., HDF B677 AND HEP B677).
P900056|S053|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2000|08/22/2000|||OK30|CHANGE IN THE POLYPROPYLENE MATERIAL USED IN THE MANUFACTURE OF THE ROTABLATOR ROTALINK ADVANCER FRONT SEAL.
P960042|S006|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159||LASER SHEATH||CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/11/2000|01/17/2001|||APPR|APPROVAL FOR AN INCREASE IN THE LASER "ON" TIME TO 10 SECONDS AND A DECREASE IN THE LASER "OFF" TIME TO 5 SECONDS.  THESE DEVICES ARE INDICATED FOR USE AS AN ADJUNCT TO CONVENTIONAL LEAD EXTRACTION TOOLS IN PATIENTS SUITABLE FOR TRANSVENOUS REMOVAL OF CHRONICALLY IMPLANTED PACING OR DEFIBRILLATOR LEADS CONSTRUCTED WITH SILICONE OR POLYURETHANE OUTER INSULATION.
P990048|S001|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||SYSTEM, LASER, PHOTODYNAMIC THERAPY|VISULAS 690S AND VISULINK PDT/U ADAPTER|MVF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/14/2000|09/27/2001|||APPR|APPROVAL FOR A REVISION OF THE INDICATION FOR USE STATEMENT TO READ "FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO MACULAR DEGENERATION, PRESUMED OCULAR HISTOPLASMOSIS, OR PATHOLOGIC MYOPIA."
P880086|S077|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AV PLUS DX|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2000|09/07/2000|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
P960030|S007|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRILL PASSIVE PLUS/AU PLUS DX|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2000|09/07/2000|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
P910023|S048|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2000|09/07/2000|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
P950022|S010|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|VENTRITEX TUL LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2000|09/07/2000|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
P900070|S027|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||Programmer, pacemaker|TRILOGY/SOLUS II/PARAGON III/PHOENIX III|KRG|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2000|09/07/2000|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY ST STERIS ISOMEDIX, MINNEAPOLIS, MN.
P880006|S033|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|V.1 2A PROGRAMMER SOFTWARE|KRG|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2000|09/07/2000|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
P960013|S008|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL SDX|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2000|09/07/2000|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
P830045|S071|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|V1. 2A PROGRAMMER SOFTWARE|KRG|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2000|09/07/2000|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FICILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS MN.
P850079|S037|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/16/2000|09/25/2000|||APPR|APPROVAL FOR THE FREQUENCY COLORS CONTACT LENSES IN PHERICAL, ASPHERIC AND TORIC CONFIGURATIONS.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES FREQUENCY COLORS, FREQUENCY ASPHERIC COLORS AND FREQUENCY TORIC COLORS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR.  THE FREQUENCY COLORS, FREQUENCY ASPHERIC COLORS ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THEY ARE ALSO INDICATED TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE, INCLUDING OCULAR MASKING, EITHER IN SIGHTED OR NON-SIGHTED EYES THAT REQUIRE A PROSTHETIC CONTACT LENS FOR THE MANAGEMENT OF CONDITIONS SUCH AS CORNEAL, IRIS OR LENS ABNORMALITIES.  THE LENS MAY ALSO BE PRESCRIBED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY OR FOR OCCLUSIVE THERAPY FOR CODITIONS SUCH AS DIPLOPIA, AMBLYOPIA OR EXTREME PHOTOPHOBIA.  THE FREQUENCY TORIC COLORS LENSES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THEY ARE ALSO INDICATED TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE, INCLUDING OCULAR MASKING, EITHER IN SIGHTED OR NON-SIGHTED EYES THAT REQUIRE A PROSTHETIC CONTACT LENS FOR THE MANAGEMENT OF CONDITIONS SUCH AS CORNEAL, IRIS OR LENS ABNORMALITIES.  THE LENS MAY ALSO BE PRESCRIBED FOR THE CORRECTINO OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENSES MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 12.00 DIOPTERS OR LESS OR FOR OCCLUSIVE THERAPY FOR CONDITIONS SUCH AS DIPLOPIA, AMBLYOPIA OR EXTREME PHOTOPHOBIA.
P990017|S008|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2000|10/16/2000|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MANUFACTURING PROCESS FOR THE ANCURE SYSTEM
P990049|S001|LUMENIS|3959 WEST 1820 SOUTH||SALT LAKE CITY|UT|84104||SYSTEM, LASER, PHOTODYNAMIC THERAPY|COHERENT OPAL PHOTOACTIVATOR|MVF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/16/2000|09/27/2001|||APPR|APPROVAL FOR A REVISION OF THE INDICATION FOR USE STATEMENT TO READ "FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA OR PRESUMED OCULAR HISTOPLASMOSIS."
P830055|S075|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2000|04/17/2001|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYCAM, INC. HOUSTON, PENNSYLVANIA.
P950022|S011|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|TVL LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Express GMP Supplement|N|08/17/2000|09/25/2000|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR LEAD PROCESSING AT ST. JUDE MEDICAL, SYLMAR, CALIFORNIA.
P960016|S005|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM:THERMISTOR ONLY TEMPERATURE SENSING|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/2000|12/01/2000|||APPR|APPROVAL FOR EIGHT NEW 4 MM TIP ELECTRODE CATHETERS WITH THERMISTOR ONLY TEMPERATURE SENSING.  THE CATHETERS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM.  THE SYSTEM IS INDICATED FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSICIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P950001|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2000|09/25/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P830060|S049|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6577 STERILIZABLE TELEMETRY WAND|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2000|09/25/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P890061|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P MODEL 16OO|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2000|09/25/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P910073|S034|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2000|09/25/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P910077|S033|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2000|09/25/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P960004|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE II/FINELINE II|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2000|09/25/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P960006|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET TIP RX STEROID ELUTING LEAD|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2000|09/25/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P970043|S009|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/04/2000|08/28/2000|||APPR|APPROVAL FOR REDUCING BY 20% THE ABLATION DEPTH VALUES THAT ARE PROVIDED IN THE PHYSICIAN BOOKLET AND DISPLAYED BY THE DEVICE.
P960016|S006|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: 5MM TIP ELECTRODE|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/2000|12/01/2000|||APPR|APPROVAL FOR TWELVE NEW CATHETERS WITH A 5 MM TIP ELECTRODE.  THE CATHETERS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC(TM) XLS(TM) CARDIAC ABLATION SYSTEM.  THE SYSTEM IS INDICATED FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P910018|S007|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Express GMP Supplement|N|08/22/2000|03/06/2003|||APPR|APPROVAL FOR THE TRANSFER OF THE ASSEMBLY AND SOLDERING OF PRINTED CIRCUIT BOARDS USED IN CONJUNCTION WITH THE FINAL ASSEMBLY OF THE MA-01 APHERESIS MACHINE TO YOKOGAWA IBIDEN COMPONENTS CORPORAITON, OUME-CITY, TOKYO 198 JAPAN.
P890064|S008|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|HCS HPV, HCII HPV|MAQ|MI|Normal 180 Day Track|Express GMP Supplement|N|08/25/2000|09/12/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT DIGENE CORPORATION, GAITHERSBURG, MD, 20878.
P990074|S001|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2000|12/06/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MCGHAN MEDICO, S.A., BARREAL DE HEREDIA, COST RICA.
P970021|S005|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2000|10/19/2001|||APPR|APPROVAL TO RELOCATE DEVICE MANUFACTURING DUE TO THE CLOSURE OF THE GYNECARE MENLO PARK FACILITY.  MANUFACTURING WILL BE PERFORMED AT RELA/COLORADO MEDTECH, INC, LONGMONT, COLORADO AND AT ETHICON, INC., SOMERVILE, NEW JERSEY.
P990064|S004|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705|||MEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL)||CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|08/29/2000|06/07/2001|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE MEDTRONIC MOSAIC PORCINE BIOPROSTHESES, MODEL 305 (AORTIC) AND MODEL 310 (MITRAL).
P980016|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||SMARTMAGNET(TM)||CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2000|02/22/2001|||APPR|APPROVAL FOR THE MODEL 9322 SMARTMAGNET(TM).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTMAGNET(TM) AND IS INDICATED FOR KEEPING MEDTRONIC ICDS FROM DELIVERING INAPPROPRIATE THERAPY, SUCH AS SHOCKS, TO PATIENTS DURING SURGICAL PROCEDURES THAT REQUIRE CAUTERY OR OTHER ELECTRICALLY NOISY DEVICES.
P960036|S003|IOLTECH, S.A.|64 SCHOOSETT STREET||PENBROKE|MA|02359|1882|intraocular lens|MEMORY LENS(R) UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Other Report|N|08/31/2000|09/25/2000|||APPR|APPROVAL TO MODIFY THE EUROPEAN PHASE-IN STUDY DESCRIBED IN SUPPLEMENT 2 DATED 8/25/00 FOR THE MEMORY LENS(R)
P960043|S026|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||CLOSER S(TM) 6FR. SMC DEVICE||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2000|09/29/2000|||APPR|APPROVAL FOR THE CLOSER S(TM) 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM.  THE DEVICE, AS MODIFIED, IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS.  THE CLOSER S(TM) 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM REDUCES THE TIMES TO HEMOSTASIS, AMBULATION (5 METERS OR 16 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS IN THE DEVICE LABELING).
P940007|S006|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|CEEON SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|09/05/2000|04/02/2001|||APPR|APPROVAL FOR STERILIZING THE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 912, AT THE FACILITY IN GRONINGEN, THE NETHERLAND AND FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS FOR MODEL 912 FROM 100% ETHYLENE OXIDE (ET0) TO 20 % ET0/80% CARBON DIOXIDE.
P880086|S078|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|INTEGRITY AFX DR/INTEGRITY SR|DXY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/2000|10/02/2000|||APPR|APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.
P900066|S004|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY|LPO|OP|Special (Immediate Track)|Postapproval Study Protocol - ODE/OIR|N|08/18/2000|09/05/2000|||APPR|APPROVAL FOR A CHANGE TO THE TOXICITY TEST PROTOCOL TO INCREASE THE NUMBER OF SAMPLES TO BE TESTED FROM EACH PRODUCTION LOT OF PERFLUOROPROPANE FROM ONE SAMPLE PER LOT TO THREE SAMPLES PER LOT.
P900056|S054|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2000|09/18/2000|||OK30|CHANGE TO THE MANUFACTURING PROCESS TEST SPECIFICATION FOR THE MINIMUM DYNAMIC DISTAL FLOW RATE.
P980016|S014|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/2000|11/29/2000|||APPR|APPROVAL FOR MEDTRONIC GEM III DR MODEL 7275 ICD AND MEDTRONIC MODEL 9970 (GEM III DR) PROGRAMMER APPLICATION SOFTWARE.  THE DEVICE, AS MODIFIED, IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIA.
P900056|S055|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2000|10/05/2000|||APPR|APPROVAL FOR A QUALITY CONTROL CHANGE FOR RECEIVING INSPECTION TO INSPECT THE SHUTTLE SPRING FOR SHARP EDGES.
P950015|S007|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|THE HEART LASER(TM)CO2 TMR SYSTEM|MNO|CV|Real-Time Process|Postapproval Study Protocol - ODE/OIR|N|09/12/2000|09/27/2000|||APPR|APPROVAL TO MODIFY THE EXISTING POST-APPROVAL STUDY TO NO LONGER REQUIRE STUDY ENROLLMENT AT NEW SITES, AND TO LIMIT STUDY PARTICIPATION TO THOSE (EXISTING) SITES WHICH HAVE ENROLLED PATIENTS.
P990052|S001|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT P SOUNDBRIDGE/VIBRANT D SOUNDBRIDGE SYSTEM|MPV|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/2000|09/21/2000|||APPR|APPROVAL FOR INCORPORATION OF A RELEASABLE BATTERY DOOR FOR THE AUDIO PROCESSOR D (MODEL 304).
P960043|S027|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||KNOT PUSHER WITH TRIMMER(TM)||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2000|10/17/2000|||APPR|APPROVAL IS FOR THE KNOT PUSHER WITH TRIMMER, AN ACCESSORY TO THE CLOSER 6 FR. SMC SYSTEM AND THE CLOSER S 6 FR. SMC SYSTEM
P910073|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE/RELIANCE S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2000|11/02/2000|||APPR|APPROVAL FOR THE LUBRICIOUS COATING, REMOVAL OF ONE SUTURE SLEEVE (ON MODELS 127, 128, 147, 148), REDUCTION OF THE YOKE (ON MODELS 147, 148, 149), AND ADDITION OF THE PUERTO RICO FACILITY FOR PACKAGING, LABELING, AND STERILIZATION.
P920048|S003|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|RAPID FFN FOR THE TLI SYSTEM|LKV|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/2000|03/09/2001|||APPR|APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN THE CALIBRATION PROCEDURE THAT ALLOWS FOR EXTENDED CALIBRATION, ACCOMPLISHED WITH A SOFTWARE MODIFICATION AND NO LONGER REQUIREING THE USE OF THE FFN POSITIVE REFERENCE CALIBRATOR;  AND  2) THE ADDITION OF A QUALITY CONTROL COMPONENT, THE TLI QC CASSETTE, FOR THE TLI ANALYZER COUPLED WITH A DECREASE IN FREQUENCY OF TESTING LIQUID CONTROLS.
P920014|S013|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE VE LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2000|10/20/2000|||APPR|APPROVAL TO MODIFY THE HEARTMATE VE SYSTEM CONTROLLER (C/N 1215) TO ACCOMODATE A NEW FOUR CELL BATTERY MODULE (BATTERY CELL), RESULTING IN VE SYSTEM CONTROLLER C/N 1216 AND BATTERY MODULE C/N 1264.
P830055|S076|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2000|11/08/2000|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE LCS ROTATING PATELLAR BEARING REPLACEMENT COMPONENT FOR THE METAL-BACKED 3-PEG ROTATING PATELLA.  THE DEVICE, AS MODIFIED, WILL BE MARKETED AS THE MODIFIED PFJ ROTATING PATELLAR BEARING REPLACEMENT COMPONENT.
P960036|S004|IOLTECH, S.A.|64 SCHOOSETT STREET||PENBROKE|MA|02359|1882|intraocular lens|MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER (IOL)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/2000|03/16/2001|||APPR|APPROVAL FOR THE CHANGE OF THE VIAL MATERIAL FROM GLASS TO PLASTIC FOR THE MEMORY LENS(R) IOL.
P980001|S025|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2000|10/12/2000|||OK30|THE 30-DAY NOTICE PROPOSED A CHANGE IN AN IN-PROCESS INSPECTION STEP TO REMOVE THE STENT IMPRINT AS A REJECTION CRITERION FOR THE ELASTOMERIC RETAINING SLEEVE COMPONENT ACCEPTANCE
P990017|S009|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/2000|01/19/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE ANCURE SYSTEM INSTRUCTIONS FOR USE.
P790017|S073|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2000|12/21/2001|||APPR|APPROVAL TO CHANGE THE SUPPLIER OF THE POLYETHYLENE TEREPHTHLATE (PET) ALLOY BALLOON TUBING USED IN THE MANUFACTURING OF THE DEVICES.
P790017|S074|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|D114S OTW BALLOON DILATATION CATHETER|LOX|CV|Real-Time Process|Other Report|N|09/14/2000|01/08/2001|||APPR|APPROVAL FOR THE ADDITION OF SIX (6) CATALOGUE ITEMS TO THE APPROVED D114S OVER-THE-WIRE BALLOON DILATATION CATHETER PRODUCT LINE.  THESE SIX ITEMS CONSIST OF A 10 MM BALLOON LENGTH IN EACH OF THE CURRENT BALLOON DIAMETERS OF 1.5 MM, 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, AND 4.0 MM.  IN ADDITION, APPROVAL FOR A MINOR DIMENSIONAL CHANGE TO THE 1.5 MM DIAMETER EXTRUDED BALLOON TUBING (0.0135"/0.0205" ID/OD FROM THE CURRENT 0.014"/0.022" ID/OD.  THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P990075|S001|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618|||SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS||SU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/08/2000|02/27/2001|||APPR|APPROVAL FOR THE MENTOR SALINE AND SPECTRUM MAMMARY PROSTHESES RETRIEVAL PROTOCOL.
P990074|S002|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|MC GHAN SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/09/2000|12/21/2000|||APPR|APPROVAL FOR THE PROTOCOLS FOR THE CONDITIONS OF APPROVAL.
P980022|S006|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325|||CONTINUOUS GLUCOSE MONITORING SYSTEM||CH|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2000|01/09/2001|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE FOR THE MANUFACTURER OF THE EXTERNAL COMPONENTS OF THE DEVICE.  THE NEW SITE IS MINIMED, INC., NORTHRIDGE, CALIFORNIA.
P830045|S072|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL|KRG|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/22/2000|10/02/2000|||APPR|APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.
P990017|S010|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2000|11/21/2000|||APPR|APPROVAL FOR THE ADDITION OF A COATING TO THE INFERIOR (TUBE ONLY) AND SUPERIOR CAPSULES (ALL CONFIGURATIONS) OF THE ANCURE(R) DELIVERY CATHETERS.
P990017|S011|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOVASCULAR GRAFT TUBE AND BIFURCATED SYSTEMS|MIH|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|09/25/2000|09/20/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE FIVE YEAR FOLLOW-UP PROTOCOL:  A) CHANGING THE FOLLOW-UP SCHEDULE;  B) REMOVING THE ULTRASOUND AND ANKLE BRACHIAL INDICES (ABI) ASSESSMENTS;  C) REPLACING THE ANNUAL PHYSICAL EXAM FOR CONTROL PATIENTS WITH AN ANNUAL TELEPHONE SURVEY AND COMPUTED TOMOGRAPHY (CT) AND PHYSICAL EXAM AT THE FIVE YEAR MARK;  D) ALLOWING AN OPTIONAL TELEPHONE SURVEY FOR PATIENTS UNABLE OR UNWILLING TO COME TO THE INVESTIGATIONAL SITE; AND  E) EXCLUDING PATIENTS WHO HAVE BEEN CONVERTED FROM FURTHER STUDY FOLLOW-UP.
P830055|S077|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2000|11/13/2000|||APPR|APPROVAL FOR A CHANGE TO THE PACKAGE INSERT REGARDING THE INDICATED USES FOR THE P.F.C. SIGMA RP CURVED TIBIAL BEARINGS.  THIS CHANGE IN INDICATION WOULD ALLOW THE P.F.C. SIGMA RP CURVED BEARINGS TO BE USED IN POSTERIOR CRUCIATE RETAINING PROCEDURES WHEN USED WITH THE P.F.C. SIGMA CRUCIATE RETAINING FEMORAL COMPONENT.
P950037|S016|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|PHILOS FAMILY OF PULSE GENERATORS|DTB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2000|10/31/2000|||APPR|APPROVAL FOR THE USE OF ALTERNATIVE COMPONENTS IN THE PHILOS FAMILY OF PULSE GENERATORS, SPECIFICALLY:  1) THE LITRONIK GMBH AND CO. MODEL LIS 3150 BATTERY; AND  2) A LOW TEMPERATURE CO-FIRE CERAMIC (LTCC) SUBSTRATE.
P950037|S017|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY|DTB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2000|05/24/2001|||APPR|APPROVAL FOR THE USE OF THE LITRONIK BATTERY MODEL LIS 3150 IN THE ACTROS+ AND KAIROS PULSE GENERATOR FAMILIES.
P960011|S006|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON(TM) 1% SODIUM HYALURONATE|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2000|03/08/2001|||APPR|APPROVAL TO CHANGE THE CLEANING IN PLACE AND STERILIZATION IN PLACE PROCESSES AND INTRODUCE AN EQUILIBRATION STEP IN THE MANUFACTURING OF BIOLON(TM).
P810002|S054|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2000|10/23/2000|||APPR|APPROVAL FOR A CHANGE TO THE AORTIC POLYESTER CUFF CONFIGURATION OF THE SJM(R) MASTER SERIES HP VALVE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM(R) MASTER SERIES HEMODYNAMIC PLUS (HP) WITH FLEX CUFF(TM), MODEL AFHPJ-505, AVAILABLE IN AORTIC SIZES 17, 19, 21, 23, 25, AND 27 MM.
P930014|S008|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF MULTI-PIECE POSTERIOR CHAMBER (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2000|10/23/2000|||OK30|THE IMPLEMENTATION OF AN AUTOMATED FINAL DIMENSIONAL INSPECTION STATION.
P950021|S003|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ACS:180 AND ADVIA CENTAUR PSA IMMUNOASSAYS|LTJ|IM|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2000|08/06/2001|||APPR|APPROVAL FOR PROCESSING AND FINAL PACKAGING AT BAYER DIAGNOSTICS, WALPOLE, MASSACHUSETTS.
P900056|S056|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2000|10/24/2000|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORK LTD., CORK, IRELAND AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND.
P910073|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/2000|10/12/2000|||APPR|APPROVAL FOR MODEL 6888 LEAD TUNNELER KIT AFTER REPLACING TUNNELING TIP MODEL 6995 WITH MODEL 6804 (USED WITH THE ENDOTAK RELIANCE / RELIANCE S LEADS
P930038|S027|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL(TM) EV VASCULAR CLOSURE DEVICE/8 AND 6 FRENCH|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/2000|10/31/2000|||APPR|APPROVAL FOR A DEVICE NAME MODIFICATION AND LONGER GUIDEWIRE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL(TM) ACCESS CLOSURE FOLLOWING 8F AND 6F DIAGNOSTIC ANGIOGRAPHY AND INTERVENTIONAL (8F ONLY) PROCEDURES.
P960028|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY(R) SILICONE MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/2000|04/25/2001|||APPR|APPROVAL FOR THE SA40N2 AND SA40E LENS MODELS.
P990004|S003|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876|||SURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGE||SU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/02/2000|11/15/2000|||APPR|APPROVAL FOR A NEW CONFIGURATION (HEMORRHOIDECTOMY SPONGE) OF THE ABSORBABLE GELATIN SPONGE, USP AS WELL AS A NEW BUBBLE WRAP PACKAGE, A CHANGE IN THE STERILIZATION PROCEDURE INVOLVING THE USE OF E-BEAM STERILIZATION, AND SOME MINOR CHANGES TO THE PACKAGE LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM(R) ABSORBA LE GELATIN SPONGE, USP, HEMORRHOIDECTOMY SPONGE AND IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT UROLOGIC AND OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P990037|S001|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DIAGNOSTIC DUETT|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/2000|11/02/2001|||APPR|APPROVAL FOR THE CHANGE IN DILUENT AND PROCOAGULANT COMPONENTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIAGNOSTIC DUETT AND IS INDICATED FOR SEALING FEMORAL ARTERIAL PUNCTURE SITES AND REDUCING TIME TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F-9F INTRODUCER SHEATH WITH AN OVERALL LENGTH NOT EXCEEDING 15.2 CM.
P980053|S001|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2000|11/01/2000|||OK30|ADDITION OF AN ALTERNATE SUBCONTRACTOR TO HEAT-SEAL THE TRAY LID PACKAGE FOR THE DURASPHERE INJECTABLE BULKING AGENT(R) AND AN ALTERNATE SUPPLIER FOR TYVEC 1078B LID FOR USE BY THE ALTERNATE SUBCONTRACTOR.
P830037|S043|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2000|11/09/2000|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN PBH LIMITED, SOUTHAMPTON, UNITED KINGDOM.
P860057|S015|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 6900 MITRAL|DYE|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|10/10/2000|05/15/2001|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOLS AND FOR A LABELING REVISION BASED ON THE RESULTS OF THE MAGNETIC RESONANCE IMAGING STUDY.
P980001|S026|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR(TM) PREMOUNTED STENT SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2000|11/08/2000|||OK30|MANUFACTURING CHANGE TO INCLUDE THE USE OF SCRAPPED MATERIAL IN FINAL FUNCTIONAL TESTING TO OBTAIN TRENDING DATA FOR SOX SECUREMENT.
P890019|S006|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS|LOL|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2000|02/02/2001|||APPR|APPROVAL FOR A CHANGE IN PURIFICATION PROCESS AND STORAGE CONDITIONS OF COMPONENTS OF THE AB-HAVK RIA DEVICE AND THE ETI-AB-HAVK PLUS DEVICE.
P870048|S008|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|EBK RIA ASSAY/ETI-EBK|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2000|02/02/2001|||APPR|APPROVAL FOR A CHANGE IN THE NEGATIVE AND POSITIVE CONTROLS AND THE NEUTRALIZING SOLUTIONS FROM DEFIBRINATED PLASMA TO SERUM AND A CHANGE IN THE PURIFICATION PROCESS AND SHELF LIFE OF SOME COMPONENTS OF THE EBK DEVICE AND THE ETI-EBK DEVICE.
P890014|S003|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS|LOL|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2000|02/02/2001|||APPR|APPROVAL FOR A CHANGE IN THE STORAGE CONDITIONS AND PURIFICATION PROCESS OF SOME COMPONENTS OF THE HA-IGMK RIA DEVICE, AND THE ETI-HA-IGMK PLUS DEVICE.
P990027|S001|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217A EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2000|12/22/2000|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TECHNOLAS GMBH, KIRCHEIM/HEIMSTETTEN, GERMANY.
P880086|S079|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFFINITY FAMILY OF PULSE GENERATORS|DXY|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2000|11/21/2000|||APPR|APPROVAL FOR THE ADDITION OF A LAYER OF KAPTON TAPE (A POLYIMIDE FILM) TO THE EDGE SIDE OF THE DEVICES' BATTERY CASE OF THE AFFINITY FAMILY OF PULSE GENERATORS.
P810046|S202|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CROSS SAIL CORONARY DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2000|11/03/2000|||OK30|MODIFICATIONS AS FOLLOWS:  1) MODIFY THE TROUBLESHOOTING PROCESS DESCRIBING HOW TO RELEASE THE TUBING FORM A MOLD; 2) MODIFY THE SET-UP/CLEANING PROCESS PRIOR TO JOINING THE DEVICE AT THE MOD-LAP JOINT; 3) MODIFY THE SET-UP PROCESS PRIOR TO PLASMA TREATING THE DEVICE.
P950020|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/2000|11/21/2000|||APPR|APPROVAL FOR A MODIFICATION TO THE DISTAL TIP OF THE CUTTING BALLOON(TM).
P810046|S203|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|RX CHASSIS I CORONARY DILATATION CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2000|01/11/2001|||APPR|APPROVAL FOR THE RX CHASSIS 1(TM) CORONARY DILATATION CATHETER.  THE DEVICE, AS MODIFIED, IS INDICATED FOR  A) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OF BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND  B) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION.
P790018|S036|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2000|11/09/2000|||OK30|ALTERNATE SUPPLIER FOR THE POLYTETRAFLUOROETHYLENE (PTFE) FABRIC CONSTRUCTED OF PTFE YARN.  THIS FABRIC IS USED TO MANUFACTURE THE SEWING RING COMPONENT FOR THE MEDTRONIC HALL PROSTHETIC HEART VALVE,  MODEL A7700, SIZES 20, 22, AND 24 MM.
P990030|S001|ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Agent, absorbable hemostatic, collagen based|COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/18/2000|01/02/2001|||APPR|APPROVAL FOR A CHANGE IN THE METHOD OF TERMINAL STERILIZATION FROM E-BEAM TO GAMMA IRRADIATION AND REQUESTED AN ADDITIONAL 3-ML DELIVERY SYRINGE DEVICE WITH THE ASSOCIATED LABELING CHANGE.
P990086|S001|SANUWAVE, INC.|11680 GREAT OAKS WAY|SUITE 350|ALPHARETTA|GA|30022||Generator, shock-wave, for pain relief|HEALTHTRONICS OSSATRON|NBN|PM|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|10/19/2000|05/01/2001|||APPR|APPROVAL FOR THE POST MARKET APPROVAL STUDY PROTOCOL.
P970035|S022|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/2000|04/04/2001|||APPR|APPROVAL FOR THE S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RZ) CORONARY STENT SYSTEMS.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM AND 4.0 MM.  LONG TERM OUTCOME (BEYOND 14 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  THE RX RELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2 CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY  THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND ALONE PTCA PERFUSION CATHETER.
P810046|S204|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2000|03/02/2001|||APPR|APPROVAL FOR NEW CATHETER MODELS.  THE DEVICES, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES POWERSAIL(TM) AND HIGHSAIL(TM) CORONARY DILATATION CATHETERS AND ARE INDICATED FOR:  1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.  3) BALLOON DILATATION OF THE ACS MULTI-LINK(TM), ACS MULTI-LINK(TM), ACS MULTI-LINK DUET(TM), ACS MULTI-LINK TRISTAR(TM), MULTI-LINK TETRA(TM) OR ACS MULTI-LINK ULTRA(TM) STENTS AFTER IMPLANTATION.
P990009|S002|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX HEMOSTATIC SEALANT|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/2000|12/12/2000|||APPR|APPROVAL FOR A LABELING CHANGE.
P940034|S011|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121|||GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)||MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2000|11/21/2000|||APPR|APPROVAL FOR MODIFICATION OF THE ENZYME DILUTION BUFFER AND TENTATIE RECONSTITUTED STABILITY (PENDING COMPLETION OF REAL-TIME STUDIES) OF THE ENZYME REAGENT FOR 30 DAYS WITH AN ADDED PRECAUTION, AND OTHER MINOR CHANGES TO THE LABELING (INCLUDING CLARIFICATION OF CONTROL TESTING PROCEDURES).
P990075|S002|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618|||MENTOR SALINE-FILLED MAMMARY PROSTHESES||SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/2000|12/22/2000|||APPR|APPROVAL FOR AN INCREASED SHELL THICKNESS OF THE CONTOUR TALL PROFILE STYLES 5000, 5000PT, 6000, AND 6000PT.
P960009|S014|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Normal 180 Day Track|Express GMP Supplement|N|10/26/2000|11/28/2000|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE MODEL 3387 AND MODEL 3389 DBS LEADS LOCATED AT MEDTRONIC NEUROLOGICAL PUERTO RICO, VILLALBA, PUERTO RICO.
P990034|S001|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED CONSTANT FLOW INFUSION PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2000|11/20/2000|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE MODEL 8472 PUMP:  1) MODIFICATION OF THE MOUNTING OF THE BELLOWS INFUSATE RESERVOIR; 2) SLIGHT CHANGES IN THE CONFIGURATION OF FIVE COMPONENT PARTS IN ORDER TO MAINTAIN THE HEIGHTS OF THE PUMPS FOLLOWING THE CHANGE IN MOUNTING; AND 3) REQUIRED CHANGES IN FIVE WELDS TO FACILITATE THE PREVIOUSLY STATED MODIFICATIONS.
P830063|S003|BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|GAMBRO PLASMAFILTER, PF2000N|MDP|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/2000|11/20/2000|||APPR|APPROVAL TO  1) EXPAND THE INSTRUCTIONS FOR USE (IFUS) TO PERMIT THE BLOOD FLOW DIRECTION DURING USE TO BE OPPOSITE TO THE DIRECTION OF FLOW OF THE RINSING AND PRIMING SOLUTIONS, AND TO 2) REMOVE THE BLOOD FLOW DIRECTION ARROW FROM THE DEVICE LABEL.
P000011|S001|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|BIODIVYSIOI AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Other Report|N|11/01/2000|05/07/2001|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BIODIVYSIO(TM) AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM.
P980016|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||GEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD)||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2000|12/12/2000|||APPR|APPROVAL FOR MEDTRONIC GEM III VR MODEL 7231 ICD AND MEDTRONIC MODEL 9971 (GEM III VR) PROGRAMMER APPLICATION SOFTWARE.  THE DEVICE, AS MODIFIED, IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIA.
P910023|S049|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|VENTRITEX ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2000|11/27/2000|||APPR|APPROVAL FOR MODEL 3510 PROGRAMMER AND SOFTWARE MODEL 3307 (V2.0).
P880086|S080|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|VENTRITEX ICD'S|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2000|11/27/2000|||APPR|APPROVAL FOR MODEL 3510 PROGRAMMER AND SOFTWARE MODEL 3307 (V2.0).
P830045|S073|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|VENTRITEX ICD'S|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2000|11/27/2000|||APPR|APPROVAL FOR MODEL 3510 PROGRAMMER AND SOFTWARE MODEL 3307 (V2.0).
P950032|S019|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF(R)(GRAFTSKIN)|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/03/2000|11/19/2001|||APPR|APPROVAL FOR PATIENT BROCHURES FOR PATIENTS WITH CHRONIC VENOUS INSUFFICIENCY AND DIABETIC ULCERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APLIGRAF AND IS INDICATED FOR USE WITH STANDARD THERAPEUTIC COMPRESSION FOR THE TREATMENT OF NON-INFECTED PARTIAL AND FULL-THICKNESS SKIN ULCERS DUE TO VENOUS INSUFFICIENCY OF GREATER THAN 1 MONTH DURATION AND WHICH HAVE NOT ADEQUATELY RESPONDED TO CONVENTIONAL ULCER THERAPY AND FOR USE WITH STANDARD DIABETIC FOOT ULCER CARE FOR THE TREATMENT OF FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS OF GREATER THAN THREE WEEKS DURATION WHICH HAVE NOT ADEQUATELY RESPONDED TO CONVENTIONAL ULCER THERAPY AND WHICH EXTEND THROUGH THE DERMIS BUT WITHOUT TENDON, MUSCLE, CAPSULE OR BONE EXPOSURE.
N18033|S034|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|11/03/2000|05/18/2001|||APPR|APPROVAL FOR ADDING THE MANUFACTURING FACILITY AT VISTAKON, JOHNSON & JOHNSON (IRELAND) LTE., LIMERICK, IRELAND, FOR THE MANUFACTURE OF ACCUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENSES.
P990001|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON DIVA PLATFORM|DXY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/08/2000|01/08/2001|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE DATE TO 18 MONTHS FROM 12 MONTHS AND RELATED LABELING CHANGES.
P960030|S008|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRILL PASSIVE PLUS/AU PLUS DX|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2000|12/07/2000|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE SUTURE SLEEVES USED WITH THE PACEMAKER LEADS: THE INCORPORATION OF TITANIUM DIOXIDE INTO THE SUTURE SLEEVE MATGERIAL TO MAKE THE MATERIAL "MORE VISIBLE DURING IMPLANT"; INCREASING THE INNER DIAMETER OF THE SLEEVE AND; REMOVAL OF THE SLEEVE EYELET'S.
P960013|S009|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL SDX|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2000|12/07/2000|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE SUTURE SLEEVES USED WITH THE PACEMAKER LEADS: THE INCORPORATION OF TITANIUM DIOXIDE INTO THE SUTURE SLEEVE MATERIAL TO MAKE THE MATERIAL "MORE VISIBLE DURING IMPLANT"; INCREASING THE INNER DIAMETER OF THE SLEEVE AND; REMOVEL OF THE SLEEVE EYELET'S.
P880086|S081|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2000|12/12/2000|||APPR|APPROVAL FOR PULSE GENERATOR MODELS INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS.
P990052|S002|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT D SOUNDBRIDGE SYSTEM|MPV|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2000|01/03/2001|||APPR|APPROVAL FOR THE INCORPORATION OF AN ALTERNATE SOURCE SUPPLIER'S SIGNAL PROCESSING CIRCUIT INTO THE AUDIO PROCESSOR(TM) D (MODEL 404).  THE DEVICE IS INDICATED FOR ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS AND DESIRE AN ALTERNATIVE TO AN ACOUSTIC HEARING AID.  PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
P990017|S012|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEMS|MIH|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/06/2000|02/15/2001|||APPR|APPROVAL FOR A MODIFICATION TO THE TRAINING PROGRAM TO ALLOW LESS THAN 100% CASE SUPPORT AT CENTERS THAT MEET THE ESTABLISHED CRITERIA.  THIS CHANGE AFFECTS THE CONDITIONS OF APPROVAL DESCRIBED IN THE ORIGINAL APPROVAL ORDER, DATED SUPTEMBER 28, 1999.
P970020|S026|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|TETRA(TM) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2000|12/05/2000|||OK30|CHANGE IN THE INSTRUCTIONS TO THE STENT CRIMP OPERATOR FOR ACCEPTABLE TWIST OF THE BALLOON FOLDS.
P000022|S001|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/06/2000|12/14/2000|||APPR|APPROVAL FOR A CHANGE IN THE LABELING TO THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE (RX) CORONARY STENT DELIVERY SYSTEM.  THE DEVICE IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYNPTOMATIC ISCHENIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM.  LONG TERM OUTCOME FOR THIS IMPLANT IS UNKNOWN AT PRESENT.  THE RAPID EXCHANGE DELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY.  THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND ALONE PTCA PERFUSION CATHETER.
P900056|S057|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2000|12/05/2000|||OK30|ALTERNATE VENDOR FOR THE BRAKE CYLINDER USED IN THE MANUFACTURE OF THE ROTABLATOR ROTALINK ADVANCER.
P910077|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI IV (AICD)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2000|12/06/2000|||APPR|APPROVAL FOR THE MODIFICATION OF THE MINI(TM) IV AICD(TM) HEADER AND REMOVING THE STERILE MINERAL OIL AND HEX WRENCH FROM THE PACKAGE.
P980050|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM III AT MODEL 7276 (ICD)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2000|02/13/2001|||APPR|APPROVAL FOR THE MEDTRONIC GEM III AT MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH THE MODEL 9465 PATIENT ASSISTANT.
P950032|S020|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/2000|11/07/2001|||APPR|APPROVAL FOR A CHANGE IN THE FINAL PRODUCT SHIPPING MEDIUM INCLUDING THE REPLACEMENT OF BOVINE INSULIN WITH FULL CHAIN HUMAN RECOMBINANT INSULIN AND THE ELIMINATION OF BSA, TRANSFERRIN, AND TRIIODOTHYRONINE.
P990078|S001|SUNRISE TECHNOLOGIES, INC.|3400 W. WARREN AVE.||FREMONT|CA|94538||Laser, ophthalmic|HYPERION LTK SYSTEM|HQF|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/2000|12/11/2000|||APPR|APPROVAL FOR A CHANGE IN THE WARNING SECTION OF THE LABELING.
P970029|S005|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|ECLIPSE TMR HOLMIUM LASER SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/2000|12/08/2000|||APPR|APPROVAL FOR TWO SPECIFIC ADDITIONAL QUALITY CONTROL INSPECTION STEPS DURING THE MANUFACTURING OF THE SOLOGRIP HANDPIECE AND THE ADDITION OF SPECIFIC LANGUAGE IN THREE PLACES TO THE INSTRUCTIONS FOR USE FOR THE SOLOGRIP HANDPIECE.
P860019|S166|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAXXUM AND NC MAXXUM PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2000|12/08/2000|||OK30|ALTERNATE MANUFACTURING METHOD FOR TAPERING THE DISTAL END OF THE CATHETER TIP BY A GRINDING METHOD.
P920015|S020|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 6725 PIN-PLUG FOR IS-1 PORT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2000|02/05/2001|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 6725 PIN-PLUG KIT.
P960043|S028|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063|||THE CLOSER(TM) AND THE CLOSER S(TM) DEVICES||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2000|12/12/2000|||OK30|REDUCING THE SHEATH TO GUIDE TENSILE STRENGTH ACCEPTANCE CRITERIA TO A MINIMUM OF 5 LBF. FROM 7 LBF.
P970012|S010|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 400 PACING SYSTEM WITH MODEL 9952 VISION - SERIOE 1.3 SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2001|03/08/2001|||APPR|APPROVAL FOR THE KAPPA 650 SERIES PULSE GENERATORS AND VISION SOFTWARE SERIES 4.0.
P980035|S009|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953 - SERIES 1.1 SOFTWARE||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2001|03/08/2001|||APPR|APPROVAL FOR THE KAPPA 650 SERIES PULSE GENERATORS AND VISION SOFTWARE SERIES 4.0.
P890003|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2001|05/07/2001|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9809 SERIES 2.0 SOFTWARE FOR USE WITH THE MEDTRONIC MODEL 9790 PROGRAMMER SERIES FOR USE IN PROGRAMMING THE MODEL 9526 REVEAL IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR.
P000018|S001|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE(TM) BETA-CATH(TM) SYSTEM|MOU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/14/2000|12/13/2000|||APPR|APPROVAL FOR THE ADDITION OF A PRECAUTION TO THE ISOTOPE IDENTIFICATION LABEL.
P900023|S034|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/15/2000|03/12/2001|||APPR|APPROVAL TO REVISE THE LABELING TO INCLUDE CANNULATION OF THE LEFT VENTRICULAR APEX WITH ANY OF THE ATRIAL CANNULAE.
P990046|S001|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/2000|05/10/2001|||APPR|APPROVAL FOR VALVE SIZES 16/19 MM AORTIC AND 24/27 MM MITRAL AND THE ADDITION OF A VALVE RESTERILIZATION INSTRUCTION IN THE LABELING.
P990046|S003|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/2000|05/10/2001|||APPR|APPROVAL FOR VALVE SIZES 16/19 MM AORTIC AND 24/27 MM MITRAL AND THE ADDITION OF A VALVE RESTERILIZATION INSTRUCTION IN THE LABELING.
N50510|S140|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE|LTW|MI|Normal 180 Day Track|Other Report|N|11/16/2000|03/09/2001|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC MINOCYCLINE AT CONCENTRATIONS OF 0.125, 0.5, AND 1 UG/ML TO THE VITEK(R) 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 AND INDICATED FOR USE IN VITEK(R) 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF GRAM POSITIVE ISOLATES TO MINOCYCLINE IN THE RANGE OF <=0.5 TO >=16 UG/ML.
N50510|S141|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN|LTW|MI|Normal 180 Day Track|Other Report|N|11/16/2000|05/14/2001|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC SPARFLOXACIN AT CONCENTRATIONS OF 0.5, 1.0, AND 8.0 MCG/ML TO THE VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK. 2 GRAM POSITIVE AST FOR SPARFLOXACIN AND IS INDICATED FOR USE IN VITEK. 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO SPARFLOXACIN IN THE RANGE OF <= 0.25 TO >= 8 MCG/ML.
P860026|S007|AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHAGMATIC/PHRENIC NERVE STIMULATOR|GZE|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2000|01/26/2001|||APPR|APPROVAL FOR CHANGING THE METHOD OF ATTACHING THE BATTERY CONNECTOR AND WIRING FROM THE POWER SWITCHES TO THE PRINTED CIRCUIT BOARD, CHANGING THE POINT WHERE THE SIGNAL IS TAKEN TO ILLUMINATE THE BATTERY LED INDICATOR, ADDING THE ENERGY SOURCE ROUTING TO THE FRONT PANEL OF THE RESPIRATORY RATE CONTROL CIRCUITRY, CHANGING THE POINT WHEE THE BATTERY POWER IS OBTAINED FOR EACH STIMULATOR OUTPUT AMPLIFIER CIRCUIT, AND DECREASING THE SENSITIVITY OF THE OSCILLATOR CIRCUIT TO TRANSISTOR OUTPUT CAPACITANCE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MARK IV AND IS INDICATED FOR PERSONS WHO REQUIRE CHRONIC VENTILATORY SUPPORT BECAUSE OF UPPER MOTOR NEURON RESPIRATORY MUSCLE PARALYSIS (RMP) OR BECAUSE OF CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION IS SUFFICIENT TO ACCOMODATE ELECTRICAL STIMULATION.
P960009|S015|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2000|12/13/2000|||OK30|MANUFACTURING PROCESS CHANGE FROM A RESISTANCE WELD TO A LASER WELD.
P940022|S016|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2000|01/12/2001|||APPR|APPROVAL FOR INCORPORATION OF THE SIZE-REDUCED SPEECH PROCESSOR TO BE WORN BEHIND THE EAR, KNOWN AS THE PLATINUM BTE(TM) SOUND PROCESSOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT PLATINUM BTE SOUND PROCESSOR.  THE DEVICE IS INDICATED TO RESTORE A LEVEL OF AUDITORY SENSATION TO INDIVIDUALS WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.  ADULTS:  1) 18 YEARS OF AGE OR OLDER  2) PROFOUND, BILATERAL SENSORINEURAL DEAFNESS (>=90DB)  3) POSTLINGUALLY DEAFENED  4) LACK OF BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.
P960058|S015|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2000|01/12/2001|||APPR|APPROVAL FOR INCORPORATION OF THE SIZE-REDUCED SPEECH PROCESSOR TO BE WORN BEHIND THE EAR, KNOWN AS THE PLATINUM BTE(TM) SOUND PROCESSOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT PLATINUM BTE(TM) SOUND PROCESSOR.  THE DEVICE IS INDICATED TO RESTORE A LEVEL OF AUDITORY SENSATION TO INDIVIDUALS WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.  CHILDREN:  1) TWO YEARS OF AGE THROUGH 17 YEARS, IF X-RAYS DEMONSTRATE EVIDENCE OF OSSIFICATION, CHILDREN AS YOUND AS 18 MONTHS MAY BE IMPLANTED.  2) PROFOUND, BILATERAL SENSORINEURAL DEAFNESS (>=90DB)  3) UNDERGONE OR BE WILLING TO UNDERGO A HEARING ADI TRIAL WITH APPROPRIATELY FITTED HEARING AIDS  4) LACK OF BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.  IN YOUNGER CHILDREN, LACK OF BENEFIT WITH HEARING AIDS IS DEFINED AS FAILURE TO ATTAIN BASIC AUDITORY MILESTONES WUCH AS A CHILD'S INCONSISTENT RESPONSE TO HIS/HER NAME ION QUIET OR TO ENVIRONMENTAL SOUNDS (MEANINGFUL AUDITORY INTEGRATION SCALE).  IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS SCORING 0% ON OPEN-SET WORK RECOGNITION (PHONETICALLY BALANCED KINDERGARTEN TEST-WORD LIST) ADMINISTERED WITH MONITORED LIVE-VOICE (70 DB SPL).  BOTH YOUNGER AND OLDER CHILDREN SHOULD DEMONSTRATE ONLY MINIMAL ABILITY ON AGE APPROPRIATE OPEN-SET SENTENCE MEASURES AND A PLATEAU IN AUDITORY DEVELOPMENT.
P000022|S002|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Other Report|N|11/16/2000|03/15/2001|||APPR|APPROVAL FOR THE POSTAPPROVAL STUDY PROTOCOL FOR THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM.
P840001|S049|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2000|12/13/2000|||OK30|A MANUFACTURING PROCESS CHANGE FROM A RESISTANCE WELD TO A LASER WELD.
P860019|S167|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|(R) QUANTUM MONORAIL(TM) PTCA CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2000|01/11/2001|||APPR|APPROVAL FOR THE BOSTON SCIENTIFIC SCIMED QUANTUM MONORAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (9, 12, 15, 18, AND 20 MM LENGTHS WITH BALLOON DIAMETERS OF 2.5 - 4.0 MM IN 1/4 MM INCREMENTS).  THE QUANTUM MONORAIL PTCA CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE QUANTUM MONORAIL PTCA CATHETER (2.5 - 4.0 MM BALLOON DIAMETERS) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P000018|S002|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE(TM) BETA-CATH(TM) SYSTEM|MOU|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2000|12/18/2000|||APPR|APPROVAL FOR THE ADDITION OF A NEW QUALITY CONTROL TEST METHOD DURING THE MANUFACTURING PROCESS OF THE B-CATH(TM) DELIVERY CATHETER.
P900056|S058|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2000|12/12/2000|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR THE ROTABLATOR ROTALINK EXCHANGEABLE CATHETER TO INCREASE THE MAXIMUM ALLOWED ENERGY USED DURING THE LASER WELD PROCESS ON THE CATHETER DRIVE ASSEMBLY HANDSHAKE.
P840062|S007|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/18/2000|12/07/2000|||APPR|APPROVAL FOR AN ADDITIONAL TRADE NAME FOR COLLACOTE, COLLATAPE AND COLLAPLUG.  THESE DEVICES WILL ALSO BE KNOWN AS HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY.  THE SIZES OF THE WOUND DRESSINGS WILL BE IDENTICAL TO THE THREE COLLACOTE PRODUCTS.  THERE WILL BE NO CHANGES IN THE DEVICE EXCEPT THE USE OF AN ADDITIONAL NEW TRADE MANE.
P870072|S010|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track||N|04/11/2000|11/15/2000|||APPR|APPROVAL FOR A SURGICAL IMPLANT ACCESSORY KIT WITH THE FOLLOWING ACCESSORIES: VENTRICULAR CANNULA VENTING CONNECTOR, VALVE HOUSING CAPS, CANNULA PLUGS, ATRIAL CANNULA TIP CAP, AND Y-CONNECTOR CAP.  THE ACCESSORY KIT WILL BE MANUFACTURED AT HORIZON MEDICAL, INC., SANTA ANA, CALIFORNIA, AND STERILIZED BY STERIGENICS, TUSTIN, CALIFORNIA.
P870072|S011|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track||N|04/24/2000|11/15/2000|||APPR|APPROVAL TO USE A HOT MELT ADHESIVE AT CABLE CONNECTION POINTS WITHIN THE UNINTERRUPTIBLE POWER SUPPLY (UPS) BATTERY PACK ASSEMBLY.
P870072|S012|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASIST DEVICE|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2000|06/01/2001|||APPR|APPROVAL FOR THE ADDITION OF THE TLC-II PORTABLE PNEUMATIC DRIVER TO THE THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM.  THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED TO BE INTERCHANGEABLE WITH THE DUAL DRIVE CONSOLE IN THE (CURRENTLY APPROVED) THORATEC PARACORPOREAL VENTRICULAR DEVICE SYSTEM FOR EITHER BRIDGE TO TRANSPLANT PATIENTS OR FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS.  THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED FOR USE EITHER IN THE HOSPITAL OR IN A MEDICALLY MONITORED RESIDENCE FACILITY.  IN ADDITION, THE TLC-II PORTABLE PNEUMATIC DRIVER CAN BE USED TO ALLOW SUITABLY QUALIFIED PATIENTS TO TAKE OFF-SITE EXCURSIONS WITHIN A TWO-HOUR TRAVEL RADIUS OF THE HOSPITAL IN THE COMPANY OF A TRAINED CAREGIVER.
P870072|S013|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/30/2000|10/31/2001|||APPR|APPROVAL FOR DESIGN CHANGES OF THE TUNNELER USED TO FACILITATE IMPLANTATION OF THE THORATEC VAD CANNULAE.
P990020|S006|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2000|02/07/2002|||APPR|APPROVAL FOR REVISIONS TO THE LABELING FOR THE DEVICE.
P980049|S003|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALTO DR ICD|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2000|12/14/2000|||APPR|APPROVAL FOR ALTO DR MODEL 614 ICD AND MODEL 61X (VERSION 1.04) PROGRAMMER APPLICATION SOFTWARE.
P950032|S021|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF(R)(GRAFTSKIN)|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2000|12/21/2000|||OK30|CHANGE IN THE RELATIVE HUMIDITY OF THE LUNAIRE INCUBATORS USED IN THE APLIGRAF MANUFACTURING PROCESS.  THE CHANGE WILL DECREASE THE RISK OF BACTERIAL CONTAMINATION DUE TO WATERBORNE ORGANISMS DURING THE MANUFACTURING PROCESS.
P970035|S023|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S670/S660/BESTENT(TM)2/WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2000|12/19/2000|||OK30|MANUFACTURING BONDING PROCESS CHANGE FOR CONVERSION BONDS AND JACKET BONDS.
P000022|S003|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|S670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2000|12/19/2000|||OK30|MANUFACTURING BONDING PROCESS CHANGE FOR CONVERSION BONDS AND JACKET BONDS.
P990027|S002|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217A EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/2000|05/17/2002|02M-0299|07/02/2002|APPR|APPROVAL THE TECHNOLAS 217A EXCIMER LASER SYSTEM.  THIS DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS:  1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -12.00 D MRSE, WITH SPHERE BETWEEN >-7.00 D TO -10.99 D AND CYLINDER BETWEEN 0.00 AND <-3.00 D;  2)  IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION; AND,  3) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER.
P970008|S015|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM CONTROL UNIT|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2000|12/06/2001|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, LONGMONT, COLORADO.
P910073|S037|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/01/2000|01/23/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 6942 BI-DIRECTIONAL TORQUE WRENCH.
P910077|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI IV (AICD)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/01/2000|01/23/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 6942 BI-DIRECTIONAL TORQUE WRENCH.
P850051|S056|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|PREMIER PACING SYSTEM|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2000|04/18/2001|||APPR|APPROVAL FOR THE PREMIER PACING SYSTEM, INCLUDING THE PREMIER MODEL 8081 VVI PACEMAKER, THE CAPSURE MODEL 4003M ENDOCARDIAL LEAD AND THE MODEL 9884 SOFTWARE FOR THE MODEL 9790 AND 9790C PROGRAMMERS.
P990017|S013|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/27/2000|12/28/2000|||APPR|APPROVAL FOR THE ADDITION OF WARNING IN THE INSTRUCTIONS FOR USE.
P930035|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/01/2000|01/23/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 6942 BI-DIRECTIONAL TORQUE WRENCH.
P960040|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV FOR ASTRID|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/01/2000|01/23/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 6942 BI-DIRECTIONAL TORQUE WRENCH.
P950034|S017|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM(R) BIORESORBABLE MEMBRAND|MCN|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2000|12/20/2000|||APPR|APPROVAL FOR A NEW SIZE OF SEPRAFILM(R) AND TO CHANGE THE NAME OF THE PRODUCT FROM SEPRAFILM(R) BIORESORBABLE MEMBRANE TO SEPRAFILM(R) ADHESION BARRIER.  THE LABELING HAS BEEN MODIFIED TO REFLECT THE NEW NAME AND NEW SIZE AND THE PACKAGE INSERT WAS MODIFIED TO BE INCLUDED WITH BOTH SIZES.  FURTHERMORE, THE LABELING HAS BEEN MODIFIED TO OMIT THE REFERENCE TO THE CLINICAL STUDY IN THE FOREIGN BODY PRECAUTION.
P990074|S003|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE FILLED BREAST IMPLANT|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2000|12/15/2000|||OK30|CHANGE IN THE PRODUCT LAL TESTING FROM A RELEASE TEST FOR EVERY STERILIZATION LOT, TO A MANUFACTURING CHANGE CONTROL TOOL USED FOR PROCESS AND MATERIAL CHANGES.  THERE WILL BE NO ADVERSE EFFECT TO THE DEVICE AS A RESULT OF CHANGING THE LAL TESTING FROM A RELEASE TEST TO A QUALIFICATION TEST. HISTORICAL RECORDS OF LAL TESTING ON FINISHED PRODUCT DEMONSTRATE THE PRODUCT MANUFACTURING PROCESS IS CONTROLLED AND PREDICTABLE, DELIVERING AN ENDOTOXIN-FREE PRODUCT.
P860019|S168|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NC MAXXUM PTCA CATHETER|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2000|06/04/2001|||APPR|APPROVAL FOR AN IMPROVED PROCESS WHICH WILL ALLOW USE OF N-HEPTANE FOR CLEANING BALLOONS AND CATHETER SHAFT COMPONENTS PRIOR TO BONDING.
P960043|S029|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|CLOSER/CLOSER S SMC 6 FRENCH SYSTEMS|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/29/2000|10/09/2001|||APPR|APPROVAL FOR EXPANDED INDICATIONS FOR USE (I.E., INTERVENTIONAL PROCEDURES).  THE CLOSER AND THE CLOSER S 6 FR. SMC SYSTEMS ARE INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS.  THE CLOSER AND THE CLOSER S 6 FR. SMC SYSTEMS REDUCE THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS).
P970051|S012|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/29/2000|01/16/2001|||APPR|APPROVAL FOR MODIFICATION TO THE FIRMWARE, COMPONENTS AND LABELING OF THE PORTABLE PROGRAMMING SYSTEM (PPS) WITH NO CHANGE TO THE CURRENTY APPROVED INDICATIONS FOR USE.
P890027|S049|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM- CHILDREN|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/29/2000|01/16/2001|||APPR|APPROVAL FOR MODIFICATION TO THE FIRMWARE, COMPONENTS AND LABELING OF THE PORTABLE PROGRAMMING SYSTEM (PPS) WITH NO CHANGE TO THE CURRENTLY APPROVED INDICATIONS FOR USE.
P840024|S080|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM- ADULTS|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/29/2000|01/16/2001|||APPR|APPROVAL FOR MODIFICATION TO THE FIRMWARE, COMPONENTS AND LABELING OF THE PORTABLE PROGRAMMING SYSTEM (PPS) WITH NO CHANGE TO THE CURRENTLY APPROVED INDICATIONS FOR USE.
P830045|S074|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|INTEGRITY DR MODEL 5336/INTEGRITY SR MODEL 5136|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2000|12/12/2000|||APPR|APPROVAL FOR PULSE GENERATOR MODELS INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS.
P980001|S027|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT DELIVERY SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2000|12/27/2000|||OK30|ELIMINATION OF THE CREEP TEST FOR ASSESSING PACKAGE SEAL INTEGRITY.
P970018|S002|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|AUTOCYTE PREP SYSTEM|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/2000|05/25/2001|||APPR|APPROVAL FOR THE ADDITION OF THE PREPMATE ACCESSORY (PREPMATE METHOD), WHICH AUTOMATES THE INITIAL MANUAL STEPS OF THE AUTOCYTE PREP LABORATORY PROCESS.  THE PREPMATE AUTOMATICALLY MIXES AND REMOVES THE SPECIMEN FROM THE GYN PRESERVATIVE VIALS, AND LAYERS THE SPECIMEN ONTO CYTORICH DENSITY REAGENT IN A TEST TUBE, AND FOR THE ADDITION OF THE MANUAL METHOD, IN WHICH, RATHER THAN USING THE AUTOCYTE PREP SYSTEM FOR CELL SUSPENSION AND SLIDE STAINING, THE CELL SUSPENSION IS MANUALLY LAYERED ONTO THE SLIDE AND STAINED BY A LABORATORY TECHNICIAN.
N17004|S013|HOWMEDICA CORP.|359 VETERANS BLVD.||RUTHERFORD|NJ|07070||BONE CEMENT|SURGICAL SIMPLEX P BONE CEMENT|LOD|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/2000|12/15/2000|||APPR|APPROVAL FOR REMOVAL OF THE REDUNDANT CHEMICAL NAME LOCATED DIRECTLY BELOW THE BRAND NAME.
P900043|S026|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT ON RAPTOR RAIL STENT DELIVERY SYSTEM (RX)|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/04/2000|04/06/2001|||APPR|APPROVAL FOR A MIDIFIED STENT/DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BX VELOCITY(TM) STENT ON RAPTORRAIL(TM) STENT DELIVERY SYSTEM (RX) AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM.
P970015|S017|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE|MAX|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2000|12/13/2000|||APPR|APPROVAL FOR THE INTERFIX(TM) RP THREADED FUSION DEVICE TO BE ALSO KNOWN AS THE INTERFIX(TM) RP THREADED FUSION DEVICE - REDUCED PROFILE.  THE DEVICE WILL NOW BE MARKETED UNDER BOTH TRADE NAMES AND WILL REMAIN INDICATED FOR USE WITH AUTOGENOUS BONE BRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL.  THE DEVICE IS TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.  THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.
P920014|S014|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|TCI HEARTMATE VE LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/2000|03/02/2001|||APPR|APPROVAL TO CHANGE THE METHOD OF CONNECTING THE PERCUTANEOUS CONTROLLER CABLE (P/N 28702) TO THE VE SYSTEM CONTROLLER (C/N 1216).
P900056|S059|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2000|12/29/2000|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR THE ROTABLATOR ROTALINK ADVANCER.  THE CHANGE WILL INCREASE THE PRESSURE WITH WHICH THE FRONT PLUG IS PRESSED INTO THE TURBINE HOUSING.
P850089|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554|DTB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/07/2000|01/08/2001|||APPR|APPROVAL TO DISTRIBUTE THE MEDTRONIC(R) CAPSURE(R) Z NOVUS MODELS 5054 AND 5554 PACING LEADS UNDER A NEW TRADE NAME.  THE DEVICES WILL BE MARKETED UNDER THE TRADE NAME VITATRON IMPLUSE II MODELS IHP 09B AND IHP 09JB AND ARE INDICATED FOR PROVIDING PERMANENT PACING AND SENSING OF THE VENTRICLE (MODEL IHP 09B) AND ATRIUM (MODEL IHP 09JB) WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
P970058|S009|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|PROMINENT CALC FEATURE MARKER|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/2000|01/22/2001|||APPR|APPROVAL FOR THE ADDITION OF A NEW CALCIFICATION MARKER.  THIS MARKER (A CIRCLE) IS INTENDED TO ENABLE THE USER OF THE IMAGECHECKER TO DIFFERENTIATE OBVIOUS CALCIFICATIONS FROM MORE SUBTLE CALCIFICATIONS THAT APPEAR IN ANALYZED MAMMOGRAMS.
P950005|S010|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/08/2000|10/05/2001|||APPR|APPROVAL FOR EXPANDING THE INDICATIONS FOR USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND IS INDICATED AS FOLLOWS:  THE BIOSENSE WEBSTER CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORIES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
P920023|S013|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESIS|MES|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/2000|05/01/2001|||APPR|APPROVAL FOR AN AUTOMATED MANUFACTURING PROCESS TO CUT STENTS TO LENTH.
P990025|S002|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER|DRF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/11/2000|09/26/2001|||APPR|APPROVAL FOR EXPANDING THE INDICATIONS FOR USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NAVISTART DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER AND IS INDICATED A FOLLOWS:  THE BIOSENSE WEBSTER NAVI-STAR DIAGNOSTIC/ABLATION CATHETER, AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING, AND FOR USE WITH A COMPATIBLE RF GENERATOR IN ADULTS AND CHILDREN 4 YEARS OF AGE AND OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.  WHEN USED WITH THE CARTO EP NAVIGATION SYSTEM, THE NAVI-STAR DIAGNOSTIC/ABLATION CATHETER PROVIDES LOCATION INFORMATION.
P000009|S001|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TACHOS DR, TACHOS DR- ATRIAL TX,TACHOS ATX|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/2000|03/05/2001|||APPR|APPROVAL FOR A NEW ICD SYSTEM WHICH INCLUDES THE FOLLOWING: TACHOS DR ICD (MODEL 335572), TACHOS DR TEST HOUSING (MODEL 122068), AND TACHOS DR AND TMS 1000 APPLICATION SOFTWARE I-HDR.0.U (MODEL 334802).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTICULAR ARRHYTHMIAS.
P990002|S001|ROCHESTER MEDICAL CORP.|ONE ROCHESTER MEDICAL DR.||STEWARTVILLE|MN|55976||Transurethral occlusion insert, urinary incontinence-control, female|FEMSOFT URETHRAL INSERT|OCK|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/14/2000|12/28/2000|||APPR|APPROVAL TO ADD THE PRECAUTION "AVOID HEAT" TO THE LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FEMSOFT(R) INSERT AND IS INDICATED FOR THE MANAGEMENT OF STRESS URINARY INCONTINENCE IN ADULT FEMALES.
P950029|S013|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/11/2001|02/02/2001|||APPR|APPROVAL FOR A NEW DIGITAL PACING CHIP, THE LOGAUTO H5, BRIO AND TALENT FIRMWARE MASK L4, AND CSO VERSION 4.16UG PROGRAMMER SOFTWARE.
P860057|S016|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|Normal 180 Day Track||N|11/17/2000|11/29/2001|||APPR|APPROVAL FOR CHANGES TO THE SUPPORT ASSEMBLY COMPONENTS OF THE SIZE 25, 27, 29, AND 31 MM VALVES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS, MODEL 6900P AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC MITRAL HEART VALVES.
P870038|S004|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|STARR EDWARDS SILASTIC BALL VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2000|01/05/2001|||OK30|CHANGE IN THE PACKAGING DESIGN FROM A TWO-PIECE MOLDED POLYSULFONE CANISTER TO A THERMOFORMED POLYCARBONATE TRAY WITH INSERT AND TYVEK LID.
P890047|S013|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|DUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/2000|02/13/2001|||APPR|APPROVAL FOR LABELING CHANGES THAT ADD TWO PRECAUTIONARY STATEMENTS TO THE DUOVISC SYSTEM  LABELING INSERT.
P840064|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT(R) SODIUM HYALURONATE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/2000|02/13/2001|||APPR|APPROVAL FOR LABELING CHANGES THAT ADD TWO PRECAUTIONARY STATEMENTS TO THE VISCOAT SOLUTION AND DUOVISC SYSTEM LABELING INSERT.
P920023|S014|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME(R) ENDOPROSTHESIS|MES|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2000|06/07/2001|||APPR|APPROVAL FOR A 1.5 CM STENT LENGTH, A MODIFICATION OF THE BENIGN PROSTATIC HYPERTROPHY (BPH) INDICATION, AND CORRECTION OF DELIVERY TOOL LABELING.  THE DEVICE, AS MIDIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLUME(R) ENDOPROSTHESIS.  THE BPH INDICATION OF THE UROLUME(R) ENDOPROSTHESIS WILL BE MODIFIED AS FOLLOWS:  THE DEVICE IS INTENDED TO RELIEVE PROSTATIC OBSTRUCTION SECONDARY TO BPH IN MEN AT LEAST 60 YEARS OF AGE, OR MEN UNDER 60 YEARS OF AGE WHO ARE POOR SURGICAL CANDIDATES, AND WHOSE PROSTATES ARE AT LEAST 2.0 CM IN LENGTH.
P930038|S028|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2000|01/16/2001|||OK30|CHANGE FROM A MANUAL CRIMPING PROCEDURE TO AN AUTOMATED PNEUMATIC PROCESS TO SEAL THE CRIMP STOP ONTO THE SUTURE.
N50510|S142|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN|LTW|MI|Normal 180 Day Track|Other Report|N|12/18/2000|05/30/2001|||APPR|APPROVAL FOR THE ADDITION TO THE VITEK. GRAM POSITIVE SUSCEPTIBILITY PANELS, THE ANTIBIOTIC MOXIFLOXACIN AT EQUIVALENT CONCENTRATIONS OF 1, 2, AND 4 MCG/ML.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR MOXIFLOXACIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS ISOLATES TO MOXIFLOXACIN IN THE RANGE OF <=0.25 TO >=8 MCG/ML.
N50510|S143|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN|LTW|MI|Normal 180 Day Track|Other Report|N|12/18/2000|06/13/2001|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC GATIFLOXACIN AT CONCENTRATIONS OF 1, 4, AND 8 MCG/ML TO THE VITEK.GRAM POSITIVE SUSCEPTIBILITY PANEL.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS AND STAPHYLOCOCCUS SAPROPHYTICUS ISOLATES TO GATIFLOXACIN IN THE RANGE OF <=0.5 TO >=8 MCG/ML.
P990074|S004|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/2000|11/07/2001|||APPR|APPROVAL FOR REVISED PATIENT LABELING THAT INCORPORATES THE RESULTS OF THE FOCUS GROUP STUDY.
P000018|S003|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH(TM) SYSTEM|MOU|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|12/19/2000|04/24/2001|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BETA-CATH(TM) SYSTEM.  THE POST-APPROVAL STUDY IS INTENDED TO VERIFY THAT THE CORRECTIVE ACTIONS, INTENDED TO HELP MINIMIZE THE INCIDENCE OF DEVICE FAILURES AND MALFUNCTIONS SEEN DURING THE PREMARKET CLINICAL INVESTIGATION, ARE SUCCESSFUL IN REDUCING THE DEVICE FAILURE AND MALFUNCTION RATE.
P980037|S003|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET(R) RHEOLYTIC THROMBECTOMY SYSTEM DRIVE UNIT|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2000|11/20/2001|||APPR|APPROVAL FOR REPLACEMENT OF THE OUTFLOW BUBBLE DETECTOR SHUTDOWN FUNCTION ON THE DRIVE UNIT 3000A WITH A VISUAL ALARM THAT IS ACTIVATED WHEN BUBBLES ARE DETECTED IN THE OUTFLOW LINE.
P980008|S005|LASERSIGHT TECHNOLOGIES, INC.|6903 UNIVERSITY BLVD.,||WINTER PARK|FL|32792||Excimer laser system|LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/2000|09/28/2001|01M-0490|10/26/2001|APPR|APPROVAL FOR THE LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK).  THE DEVICE IS INDICATED FOR LASIK:  1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM -0.5 TO LESS THAN -6.0 DIOPTERS (D) SPHERICAL EQUIVALENT, WITH ASTIGMATISM LESS THAN OR EQUAL TO 4.5 D, AS MEASURED AT THE SPECTACLE PLANE;  2) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D, OR <= 10% OF PREOPERATIVE SPHERICAL EQUIVALENT REFRACTION (SER) SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND,  3) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER.
P810046|S205|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/2000|01/24/2001|||APPR|APPROVAL FOR THE REVISION OF THE CROSSSAIL AND OPENSAIL CORONARY DILATATION CATHETER'S COMPLIANCE CHARTS.  THESE CATHETERS ARE INDICATED FOR:  1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND  2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.
P990066|S002|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2000|01/08/2001|||APPR|APPROVAL FOR THE KODAK DRYVIEW 8610 PRINTER FOR USE WITH THE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
P910023|S050|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2000|01/18/2001|||OK30|USE OF AN ALTERNATE STERILIZATION CHAMBER FOR THE ICDS AND TACHYCARDIA LEADS AND IS ALSO REQUESTING APPROVAL FOR USE OF PARAMETRIC RELEASE AS AN ALTERNATE TO THE CURRENT USE OF BIOLOGICAL INDICATORS IN THE RELEASE OF STERILIZED PRODUCTS.
P950022|S012|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2000|01/18/2001|||OK30|USE OF AN ALTERNATE STERILIZATION CHAMBER FOR THE ICDS AND TACHYCARDIA LEADS AND IS ALSO REQUESTING APPROVAL FOR USE OF PARAMETRIC RELEASE AS AN ALTERNATE TO THE CURRENT USE OF BIOLOGICAL INDICATORS IN THE RELEASE OF STERILIZED PRODUCTS.
P970042|S001|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotripter, shockwave (for treating gallbladder stones)|MEDSTONE STS LITHOTRIPTER|NCV|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|12/18/2000|02/05/2001|||APPR|APPROVAL FOR SEVERAL CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.  SPECIFICALLY, THESE CHANGES ARE  1) CHANGES TO INCLUSION CRITERIA 3 AND 5  2) CHANGES TO EXCLUSION CRITERIA 7, 8, 9, 10, 11, 13, 15, AND 16  3) ELIMINATION OF THE ULTRASOUND EVALUATION IMMEDIATELY POST-LITHOTRIPSY,  4) ELIMINATION OF THE ORAL CHOLECYSTOGRAM AT THE SIX-MONTH VISIT, AND  5) ADDITION OF STATEMENTS TO CLARIFY GUIDELINES FOR SCHEDULING FOLLOW-UP VISITS AND TO LIST PROTOCOL REQUIREMENTS BY STUDY VISIT.
P950037|S018|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|PHILOS PACING SYSTEM|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/2001|02/05/2001|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION B-K02.V.U.
P910001|S019|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/2000|06/19/2001|||APPR|VITESSE POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODEL 110-004, AND THE EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODEL 110-002:  1) A CHANGE IN THE LASTING TIME FROM 5 SECONDS ON AND 10 SECONDS OFF TO 10 SECONDS ON AND 5 SECONDS OFF;  2) A CHANGE IN THE FLUENCE AND REPETITION RATE FROM 30-60 FLUENCE AND 25-40 HZ TO 30-80 FLUENCE AND 25-80 HZ;  3) A LABELING CHANGE FROM "LASER ADVANCEMENT OF APPROXIMATELY 1 MM PER SECOND" TO "MAINTAIN CONSTANT CATHETER TIP CONTACT WITH THE LESION BY APPLYING MILD FORWARD PRESSURE TO THE SHAFT OF THE CATHETER"; AND  4) A CHANGE IN THE PIN CODE ON THE COUPLER SO THAT THE CATHETERS INSTRUCT THE LASER SYSTEM TO ALLOW INCREASED LASING PARAMETERS.
P990025|S003|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER\|DRF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2000|01/11/2001|||OK30|CHANGE TO THE POLYMERIC MIXTURE USED TO MANUFACTURE THE CATHETER'S TIP.  THE CHANGE IS INTENDED TO STANDARDIZE PROCESSES ACROSS THE NAVI-STAR PRODUCT LINE.
P950035|S009|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND II SYSTEM|GZC|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2000|01/18/2002|||APPR|APPROVAL FOR THE UNIVERSAL EXTERNAL CONTROLLER (UEC), REVISED FREEHAND CLINICIAN PROGRAMMING INTERFACE SOFTWARE, VERSION 5.0, WHICH ARE USED TO OPERATE AND PROGRAM THE FREEHAND IMPLANTABLE-RECEIVER STIMULATOR, AND SUBSEQUENT CHANGES TO THE LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FREEHAND II SYSTEM.
P960043|S030|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|THE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2000|02/02/2001|||APPR|APPROVAL FOR DESIGN CHANGES TO THE MULTI-LUMEN STRUCTURE OF THE SHEATH (FROM 5 LUMENS TO 3 LUMENS), AS WELL AS COMBINING THE EXIT RAMP AND PEBAX BEADING INTO A SINGLE INJECTION MOLDED PEBAX COMPONENT TO SIMPLIFY THE MANUFACTURING PROCESS.  THESE MODIFICATIONS APPLY TO BOTH THE CLOSER 6 FR. SMC SYSTEM AND THE CLOSER S 6 FR. SMC SYSTEM.
P990078|S004|SUNRISE TECHNOLOGIES, INC.|3400 W. WARREN AVE.||FREMONT|CA|94538||Laser, ophthalmic|SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)|HQF|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/2000|03/16/2001|||APPR|APPROVAL FOR A SOFTWARE MODIFICATION TO THE EYE TRACKER.
P960004|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE II/FINELINE II STEROX PACING LEADS|DTB|CV|Normal 180 Day Track|Express GMP Supplement|N|12/26/2000|02/15/2001|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.  THE MANUFACTURING SITE WILL PERFORM THE STERILIZATION, PACKAGING AND LABELING OF THE DEVICE.
P960040|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK(R) PRIZM(TM) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD-TM) SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2000|02/01/2001|||APPR|APPROVAL FOR THE MODIFICATION OF THE PRIZM AICD HEADER.
N16420|S005|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION|POLYTEF PASTE FOR INJECTION|LTG|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2000|05/30/2001|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MENTOR CORPORATION, MINNEAPOLIS, MN, AND APPROVAL FOR TWO STERILIZATION SITES LOCATED AT STERIS ISOMEDIX, INC., MINNEAPOLIS, MN, AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MN.
P920004|S014|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL EXTRA SECURITY (ES) DEVICE|MGB|CV|Normal 180 Day Track|Express GMP Supplement|N|12/26/2000|03/13/2001|||APPR|APPROVAL TO MANUFACTURE THE VASOSEAL ES DEVICE AT A NEW FACILITY LOCATED AT DATASCOPE CORP. MAHWAH, NEW JERSEY.
P000018|S005|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE 40 MM BETA-CATH SYSTEM|MOU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/28/2000|06/15/2001|||APPR|APPROVAL FOR THE NOVOSTE(TM) 40 MM BETA-CATH SYSTEM.  THE NOVOSTE(TM) 40 MM BETA-CATH(TM) SYSTEM IS INTENDED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS (TREATABLE WITH A 20 MM BALLOON) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 TO 4.0 MM.
P970051|S013|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/2000|03/02/2001|||APPR|APPROVAL FOR A NEW HEADSET, HS9, WHICH CONSISTS OF A LAPEL MICROPHONE, A TRANSMITTING COIL AND A CABLE DESIGNED TO CONNECT DIRECTLY TO THE SPRINT SPEECH PROCESSOR.
P990033|S002|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15 FLOW (FORMERLY PEPGEN P-15 PUTTY)|NPZ|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/02/2001|08/09/2001|||APPR|APPROVAL FOR A MODIFICATION TO PEPGEN P-15 TO FORM PEPGEN P-15 PUTTY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PEPGEN P-15 FLOW, BUT HAVE THE SAME INDICATIONS FOR USE AS PEPGEN P-15.
P930027|S004|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000|LTJ|IM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/02/2001|06/19/2001|01M-0535|12/05/2001|APPR|IMMULITE PSA, IMMULITE. THIRD GENERATION PSA, IMMULITE 2000 PSA, AND IMMULITE 2000 THIRD GENERATION PSA.  IMMULITE. PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER.  IMMULITE THIRD GENERATION PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER.  IMMULITE 2000 PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER.  IMMULITE 2000 THIRD GENERATION PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OF OLDER.
N50510|S144|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN|LTW|MI|Normal 180 Day Track|Other Report|N|01/03/2001|06/13/2001|||APPR|APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC QUINUPRISTIN/DALFOPRISTIN AT CONCENTRATIONS OF 0.75, 1.5, AND 3 MCG/ML TO THE VITEK. GRAM POSITIVE SUSCEPTIBILITY PANEL.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS,  VANCOMYCIN-RESISTANT ENTEROCOCCUS FAECIUM, STAPHYLOCOCCUS EPIDERMIDIS, AND STREPTOCOCCUS AGALACTIAE ISOLATE TO QUINUPRISTIN/DALFOPRISTIN IN THE RANGE OF <=.5 TO >=4 MCG/ML.
P950029|S014|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2001|07/03/2001|||APPR|APPROVAL FOR THE AUTOTHRESHOLD FEATURE ON TWO TALENT MODEL PACEMAKERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT MODELS DR233 AND SR133 AND IS INDICATED FOR THE FOLLOWING: RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY.  THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: 1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK; 2) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; 3) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; 4) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; 5) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES.  DUAL-CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.  DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE:  1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; 2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.
P990054|S001|Boston Scientific Corp.|2710 ORCHARD PKWY.||SAN JOSE|CA|95113||Cardiac ablation percutaneous catheter|CHILLI  COOLED ABLATION SYSTEM|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/05/2001|02/15/2001|||APPR|APPROVAL FOR AN ACCELERATED AGING PROTOCOL TO BE USED TO EXTEND THE SHELF LIFE OF THE APPROVED DEVICES.
P000018|S006|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2001|01/29/2001|||OK30|CHANGE IN THE INSERT MOLDING PROCESS PARAMETERS FOR A COMPONENT OF THE PROPRIETARY CONNECTOR (THE PUCK), WHICH IS MOLDED TO THE 3-LUMEN TUBING OF THE DELIVERY CATHETER.
P930038|S029|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE:SELF-TIGHTENING SLIPKNOT(STS)|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/2001|07/26/2001|||APPR|APPROVAL FOR THE SELF-TIGHTENING SLIPKNOT (STS) MODIFICATION TO THE ANGIO-SEAL VASCULAR CLOSURE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE: SELF-TIGHTENING SLIPKNOT (STS) AND IS INDICATED FOR CLOSING AND REDUCING THE TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERTONE A DIAGNOSTIC ANGIOGRAPHIC PROCEDURE OR AN INTERVENTIONAL PROCEDURE USING AN 8FRENCH PROCEDURAL SHEATH FOR THE 8F ANGIO-SEAL STS DEVICE AND A 6F OR SMALLER PROCEDURAL SHEATH FOR THE 6F ANGIO-SEAL STS DEVICE.
P000020|S001|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER(TM) AND STINGER S(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/2001|05/18/2001|||APPR|APPROVAL FOR A CHANGE TO THE MATERIALS OF THE CATHETER TIP TO INCREASE ITS STIFFNESS AND OTHER MINOR DEVICE MODIFICATIONS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STIN S ABLATION CATHETER AND IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS, AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.
P860057|S017|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/2001|05/15/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE SIZE 33 MM VALVE.
P000020|S002|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER(TM) M ABLATION CATHETER/TEMPLINK(TM) M EXTENSION CABLE|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2001|02/07/2001|||APPR|APPROVAL FOR THE STINGER M ABLATION CATHETER (MODELS 210001M - 210006M) AND THE TEMPLINK M CABLE (MODEL 210078M).  THE DEVICES ARE INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCDURES TO TREAT ARRHYTHMIAS AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.
P990028|S002|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Mesh, surgical, polymeric|FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT|FTL|AN|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2001|07/16/2001|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT CHESAPEAKE BIOLOGICAL LABORATORIES, INC., BALTIMORE, MD.  THE FACILITY WILL PERFORM THE ASEPTIC FORMULATION AND FILLING OF PRIMER VIAL 2 OF FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT.
P980006|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH AND LOMB BALAFILCON A HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2001|06/28/2002|||APPR|APPROVAL FOR AN ALTERNATE BIOLOGICAL INDICATOR, THE 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR, TO MONITOR THE STERILIZATION PROCESSES AND TO USE ONLY THE FLUORESCENT ENZYME 3 HOUR READOUT SYSTEM FOR ROUTINE DISPOSITION OF THE PRODUCT.  THE FLUORESCENT READOUT SYSTEM BY ITSELF WILL NOT BE USED TO VALIDATE THE STERILIZATION PROCESSES.
P960022|S002|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH AND LOMB ALPHAFILCON A HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2001|06/28/2002|||APPR|APPROVAL FOR AN ALTERNATE BIOLOGICAL INDICATOR, THE 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR, TO MONITOR THE STERILIZATION PROCESSES AND TO USE ONLY THE FLUORESCENT ENZYME 3 HOUR READOUT SYSTEM FOR ROUTINE DISPOSITION OF THE PRODUCT.  THE FLUORESCENT READOUT SYSTEM BY ITSELF WILL NOT BE USED TO VALIDATE THE STERILIZATION PROCESSES.
P980053|S002|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2001|01/23/2001|||OK30|ADDITION OF AN ALTERNATE VENDOR, CARBON COATING TECHNOLOGIES, TO SUPPLY THE PYLORIC CARBON COATED BEAD COMPONENT OF THE DURASPHERE INJECTABLE BULKING AGENT(R)
P850068|S008|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, extended wear|BAUSCH AND LOMB ELASTOFILCON A HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2001|06/28/2002|||APPR|APPROVAL FOR AN ALTERNATE BIOLOGICAL INDICATOR, THE 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR, TO MONITOR THE STERILIZATION PROCESSES AND TO USE ONLY THE FLUORESCENT ENZYME 3 HOUR READOUT SYSTEM FOR ROUTINE DISPOSITION OF THE PRODUCT.  THE FLUORESCENT READOUT SYSTEM BY ITSELF WILL NOT BE USED TO VALIDATE THE STERILIZATION PROCESSES.
N16895|S088|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH AND LOMB POLYMACON HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2001|06/28/2002|||APPR|APPROVAL FOR AN ALTERNATE BIOLOGICAL INDICATOR, THE 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR, TO MONITOR THE STERILIZATION PROCESSES AND TO USE ONLY THE FLUORESCENT ENZYME 3 HOUR READOUT SYSTEM FOR ROUTINE DISPOSITION OF THE PRODUCT.  THE FLUORESCENT READOUT SYSTEM BY ITSELF WILL NOT BE USED TO VALIDATE THE STERILIZATION PROCESSES.
N17676|S028|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14692|0450|Lenses, soft contact, daily wear|BAUSCH AND LOMB HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES|LPL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2001|06/28/2002|||APPR|APPROVAL FOR AN ALTERNATE BIOLOGICAL INDICATOR, THE 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR, TO MONITOR THE STERILIZATION PROCESSES AND TO USE ONLY THE FLUORESCENT ENZYME 3 HOUR READOUT SYSTEM FOR ROUTINE DISPOSITION OF THE PRODUCT.  THE FLUORESCENT READOUT SYSTEM BY ITSELF WILL NOT BE USED TO VALIDATE THE STERILIZATION PROCESSES.
P880029|S015|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH AND LOMB LIDOFILCON A AND B HYDROPHILIC CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2001|06/28/2002|||APPR|APPROVAL FOR AN ALTERNATE BIOLOGICAL INDICATOR, THE 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR, TO MONITOR THE STERILIZATION PROCESSES AND TO USE ONLY THE FLUORESCENT ENZYME 3 HOUR READOUT SYSTEM FOR ROUTINE DISPOSITION OF THE PRODUCT.  THE FLUORESCENT READOUT SYSTEM BY ITSELF WILL NOT BE USED TO VALIDATE THE STERILIZATION PROCESSES.
P970024|S004|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable cardioverter defibrillator (non-CRT)|LYRA(TM) ICD SYSTEMS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/2000|02/06/2001|||APPR|APPROVAL FOR THE FIRMWARE MODIFICATIONS IN THE LYRA(TM) ICD SYSTEMS.
P980049|S004|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ORCHESTRA PROGRAMMER|MRM|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/2001|01/31/2001|||APPR|APPROVAL FOR A "CAUTION:" LABEL TO BE PLACED ON THE ORCHESTRA PROGRAMMER.
P990086|S002|SANUWAVE, INC.|11680 GREAT OAKS WAY|SUITE 350|ALPHARETTA|GA|30022||Generator, shock-wave, for pain relief|HEALTHTRONICS OSSATRON|NBN|PM|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/2001|03/30/2001|||APPR|APPROVAL FOR CERTAIN ERGONOMIC AND SAFETY DESIGN CHANGES AND A DEVICE PERFORMANCE CHANGE, I.E., PROVIDING THE OPTION OF USING 4 HZ FREQUENCY OF THE SHOCK WAVE DELIVERY, AS WELL AS LABELING CHANGES IN THE OPERATOR MANUAL TO PROVIDE ADEQUATE INSTRUCTIONS AND INFORMATION ABOUT THESE CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEALTHTRONICS OSSATRON(R) AND IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE (ESW) TREATMENT IN PATIENTS WITH CHRONIC PROXIMAL PLANTAR FASCIITIS THAT HAVE FAILED TO RESPOND TO CONSERVATIVE TREATMENT.  CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS PAIN IN THE AREA OF INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
P990009|S004|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX (AKA PROCEED) HEMOSTATIC SEALANT|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2001|02/28/2001|||APPR|APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM.
P970051|S014|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (NUCLEUS 24 CONTOUR COCHLEAR IMPLANT|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/2001|02/08/2001|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM SIX (6) MONTHS TO TWO (2) YEARS.
P970020|S027|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2001|05/07/2001|||APPR|APPROVAL FOR THE ACS MULTI-LINK CORONARY STENT SYSTEMS.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYNMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH # 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM; AND  2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (# MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 MM TO 4.0 MM.  LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  NOTE: THE 2.5 MM AND 2.75 MM DIAMETERS, AND 33 MM AND 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE.
P950032|S022|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF(GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2001|04/26/2001|||APPR|APPROVAL FOR REPLACEMENT OF THE SOYBEAN TRYPSIN INHIBITOR REAGENT IN APLIGRAF MANUFACTURE WITH THE NEWLY DEFINED TRYPSIN QUENCHING MEDIUM.
P000018|S007|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH(TM)SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2001|02/13/2001|||OK30|CHANGE IN THE SUPPLIER AND THE MANUFACTURING METHOD USED IN FORMING THE PROPRIETARY CONNECTOR OF THE BETA-CATH(TM) DELIVERY CATHETER, FROM A MACHINED TO A MOLDED PROCESS.
P920032|S006|PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||PULSE-GENERATOR, PACEMAKER, EXTERNAL|MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER|DTE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/18/2001|04/06/2001|||APPR|APPROVAL TO MODIFY THE TEMPORARY PACEMAKERS BY REPLACING THE ZENER DIODES USED FOR PROTECTING THE INTERNAL ELECTRONICS FROM HIGH VOLTAGE TRANSIENTS WITH A TRANSIENT VOLTAGE SUPPRESSOR.
P940031|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY(TM)/MERIDIAN(TM)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/19/2001|02/26/2001|||APPR|APPROVAL FOR THE INTRODUCTION OF THE PDM SOFTWARE APPLICATION MODEL 28990 VERSION 4.3.
P000011|S002|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|BIODIVYSIO AS OTW|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/18/2001|07/03/2001|||APPR|APPROVAL FOR THE 11 MM AND 15 MM BIODIVYSIO(TM) AS OTW.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO(TM) AS OTW AND IS INDICATED FOR: "USE IN SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >= 3.0 MM TO <= 4.0 MM AND INTENDED TO IMPROVE CORONARY LUMEN DIAMETER.  LONG TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT."
P900060|S022|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2001|02/16/2001|||OK30|INCREASING THE STERILIZATION LOAD SIZE FOR CPHV(TM) AND UTILIZE MIXED LOADS OF CPHV(TM) AND ANNULOPLASTY RINGS (ANNULOFLO(R), AND/OR ANNULOFLEX(TM), TO MAXIMUM OF 384 BARRIERS IN THE SAME CYCLE AT TH EAUSTIN AND CALGARY FACILITIES.
P970004|S011|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM FOR URINARY CONTROL THERAPY, 3080/3886 LEAD KITS|EZW|GU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2001|02/05/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATIVE TUNGSTEN STYLET FOR LEAD KITS 3080/3886 AND MINOR CHANGES TO THE LABELING.
P990037|S002|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369|||VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2001|03/14/2001|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE MANUAL.
P950008|S002|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2001|02/08/2001|||APPR|APPROVAL FOR CHANGE OF STOPPER FOR THE CONTAINER/CLOSURE SYSTEM FOR SILIKON(TM) 1000.
P980001|S028|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2001|02/21/2001|||OK30|CHANGE IN THE ACCEPTANCE CRITERIA OF A GEL LUMP FROM 0.005" TO 0.010" ON THE SOX(TM) COMPONENT.
N17600|S017|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE ULTRA FOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) SPONGE|LMF|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2000|07/11/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE SLURRY PREPARATION AND LYOPHILIZATION PROCESS AND ADJUSTMENTS TO THE PRODUCT SPECIFICATIONS RESULTING FROM THESE MANUFACTURING CHANGES.
P990009|S003|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL (R) MATRIX HEMOSTATIC SEALANT AND PROCEED (TM) HEMOSTATIC SEALANT|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2000|07/10/2001|||APPR|APPROVAL FOR A DRY FORM OF FLOSEAL(R) MATRIX AND PROCEED(TM) HEMOSTATIC SEALANTS.
P970020|S028|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/2001|03/02/2001|||APPR|APPROVAL FOR A MODIFIED PRECAUTION STATEMENT IN THE INSTRUCTIONS FOR USE OF THE ACS MULTI-LINK RX AND OTW ULTRA(TM) CORONARY STENT SYSTEMS.
P970020|S029|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX TETRA CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2001|02/26/2001|||OK30|MANUFACTURING PROCESS CHANGE TO THE INNER SUPPORT MANDREL IN THE RPAID EXCHANGE (RX) VERSION OF THE MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM.
P990050|S001|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD,SUITE|11|SAN DIEGO|CA|92121||ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)|OPTICAL BIOPSY(TM) SYSTEM|MOA|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/25/2001|02/16/2001|||APPR|APPROVAL FOR TWO ADDITIONAL WORKING LENGTHS OF OPTICAL FIBERS TO BE INCLUDED WITH THE OPTICAL BIOPSY(TM) SYSTEM.
P950015|S008|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|HEART LASER 2 (HL2)|MNO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2000|01/29/2001|||APPR|APPROVAL FOR A MANUFACTURING CHANGE TO UP-DATE THE LASER CONSOLE PORTION OF THE DEVICE SYSTEM FROM THE CURRENTLY APPROVED HL1 (HEART LASER(TM)) TO THE HL2 (HEAR LASER 2).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEART LASER 2 (HL2), AND IS INDICATED FOR USE IN THE TREATMENT OF PATIENTS WITH STABLE ANGINA (CANADIAN CARDIOVASCULAR SOCIETY CLASS 3 OR 4) REFRACTORY TO MEDICAL TREATMENT AND SECONDARY TO OBJECTIVELY DEMONSTRATED CORONARY ARTERY ATHEROSCLEROSIS AND WITH A REGION OF THE MYOCARDIUM NOT AMENABLE TO DIRECT CORONARY REVASCULARIZATION.
P900009|S012|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM|LPQ|OR|Normal 180 Day Track||N|10/12/2000|02/21/2001|||APPR|APPROVAL FOR A CHANGE IN LABELING FOR THE EXOGEN 3000(R), TO INCORPORATE BOTH THE FRESH FRACTURE AND NONUNION INFORMATION INTO ONE SET OF PHYSICIAN'S INSTRUCTIONS FOR USE, PATIENT'S INSTRUCTIONS FOR USE, AND PRODUCT INSERT BULLETIN; TO MAKE MANUAL SIZE AND FORMATTING CHANGES, AND TO ADD NONUNION BACKGROUND INFORMATION.
P990009|S001|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|PROCEED HEMOSTATIC SEALANT|LMF|SU|Real-Time Process|Other Report|N|10/04/2000|01/22/2001|||APPR|APPROVAL FOR THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" FOR PROCEED(TM) HEMOSTATIC SEALANT.
P990001|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|DEMA, DIVA AND AFM PULSE GENERATORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2001|03/07/2001|||APPR|APPROVAL FOR THE SOFTWARE VERSION PRO VIT VSA02 V6.1 DEMA, DIVA, AND SELECTION OF AFM PULSE GENERATORS.
P970003|S030|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|MODEL 150 NEUROCYBERNETIC PROSTHESIS SYSTEM PROGRAMMING SOFTWARE (VERSION 6)|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/26/2001|02/27/2001|||APPR|APPROVAL FOR THE SYSTEM MODEL 250 NCP PROGRAMMING SOFTWARE (VERSION 6).
P810002|S055|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MECHANICAL HEART VALVE, MASTER SERIES COATED AORTIC VALVED GRAFT|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2001|03/16/2001|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT STERIS ISOMEDIX, VEGA ALTA, PUERTO RICO.
P990074|S005|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|MCGHAN SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/2001|04/09/2001|||APPR|APPROVAL FOR A NEW SERIES OF SIZES FOR THE STYLE 363 SALINE-FILLED BREAST IMPLANT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MCGHAN SALINE-FILLED BREAST IMPLANTS, STYLE 363LF AND IS INDICATED FOR:  1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER AND  2) BREAST RECONSTRUCTION.
P960043|S031|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|CLOSER / CLOSER S 6 FRENCH SMC SYSTEMS|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2001|11/20/2001|||APPR|APPROVAL FOR THE CLOSER 6 FR. SYSTEMS DURING INTERVENTIONAL CATHETERIZATION (EXPANDED INDICATIONS FOR USE) REQUIRING 7 TO 8 FR. SHEATHS.  THE CLOSER AND THE CLOSER S 6 FR. SMC SYSTEMS ARE MODIFIED, AS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 8 FR. SHEATHS.  THE CLOSER AND THE CLOSER S 6 FR. SMC SYSTEMS REDUCED THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS).
P840001|S050|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) 3 SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/2001|07/26/2001|||APPR|APPROVAL FOR THE ITREL(R) EZ(TM) MODEL 7434A PATIENT PROGRAMMER, TO BE USED WITH THE MODEL 7425 ITREL(R) 3 IMPLANTABLE PULSE GENERATOR, AND LABELING MODIFICATIONS RESULTING FROM THE INTRODUCTION OF THE NEW PATIENT PROGRAMMER.
P960039|S002|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, extended wear|SOFT-55 EW APHAKIC (VIFILCON A) SOFT(HYDROPHILIC) SPHERICAL CONTACT LENS FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2001|01/03/2002|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT UNILENS CORPORATION, USA, LARGO, FLORIDA.
P970053|S005|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/2001|03/15/2001|||APPR|APPROVAL TO MODIFY THE DEVICE BY THE ADDITION OF SECURITY SOFTWARE AND A HARDWARE BLOCK TO PRECLUDE THE USE OF UNAPPROVED SOFTWARE.
P970029|S006|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TMR2000 HOLMIUM LASER SYSTEM|MNO|CV|Normal 180 Day Track|Other Report|N|01/24/2001|12/03/2002|||APPR|APPROVAL FOR MODIFICATION TO THE POST-APPROVAL STUDY FOR THE DEVICE.
N18033|S035|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/2001|04/12/2001|||APPR|APPROVAL FOR AN ETAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR WITH UV BLOCKER AND THE FOLLWOING LISTED COLOR ADDITIVES: IRON OXIDE BLACK, IRON OXIDE BROWN, IRON OXIDE RED, IRON OXIDE YELLOW, TITANIUM DIOXIDE, PHTHALOCYANINATO (2-) COPPER, PHTHALOCYANINE GREEN AND VAT ORANGE 1.  THE DEVICE WILL BE MARKETED WITH THE FOLLOWING TRADE NAMES AND INDICATNIONS:  THE ACUVUE (R) 2 COLOURS CONTACT LENSES ARE INDICATED FOR DAILY WEAR TO ENHANCE OR LATER THE APPARENT COLOR OF THE EYE AND/OR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 1.00D OR LESS OF ASTIGMATISM.  THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC, APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 0.75D OF ASTIGMATISM OR LESS.  THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE HYPEROPIC OR MYOPIC AND MAY HAVE 10.00D OF ASTIGMATISM OR LESS.  THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) TORIC-BIFOCAL CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED WHO MAY HAVE 10.00D OR ASTIGMATISM OR LESS.  ACUVUE(R) 2 COLOURS UV BLOCKING CONTACT LENSES HELP PROTECT AGAINST TRANSMISSINO OF HARMFUL UV RADIATINO TO THE CORNEA AND INTO THE EYE.  THE ACUTVUE(R) 2 COLOURS CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR.  EYE CARE PRACTITIONERS MAY PRESCRIBE THE LENSES EITHER FOR SINGLE-USE DISPOSABLE WEAR OR FREQUENT/PLANNED REPLACEMENT WEAR WITH CLEANING, DISINFECTION AND SCHEDULED REPLACEMENT (SEE "WEARING SCHEDULE".)  WHEN PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR, THE LENSES MAY BE DISINFECTED USING A CHEMICAL DISINFECTIO
P860003|S038|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR(R) XTS(R) PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2001|02/15/2001|||OK30|CHANGE IN THE USE OF DYMAX 29048 UV CURABLE ADHESIVE FOR SEALING THE TWO ACRYLIC PHOTOACTIVATION PLATES TO USING RADIO FREQUENCY WELDING.
P980037|S004|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC XMI THROMBECTOMY CATHETER|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2001|11/20/2001|||APPR|APPROVAL FOR THE XMI CATHETER, A MODIFICATION OF THE LF140 CATHETER.  THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME POSSIS ANGIOJET XMI RHEOLYTIC THROMBECTOMY SYSTEM, AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SAPHENOUS VEIN GRAFT LESIONS IN VESSELS >=2.0 MM IN DIAMETER PRIOR TO BALLOON ANGIOPLASTY OR STENT PLACEMENT.
P990009|S005|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL(R) MATRIX/PROCEED(TM) HEMOSTATIC SEALANT|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2001|03/15/2001|||APPR|APPROVAL FOR A MODIFICATION KIT CONFIGURATION WITHOUT THE THROMBIN COMPONENT.
P850007|S026|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track|Express GMP Supplement|N|02/01/2001|03/09/2001|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHOFIX, INC., MCKINNEY, TEXAS.
P880086|S082|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2001|03/02/2001|||APPR|APPROVAL FOR THE PROGRAMMER SOFTWARE MODEL 3307 V2.1.
P830045|S075|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2001|03/02/2001|||APPR|APPROVAL FOR THE PROGRAMMER SOFTWARE MODEL 3307 V2.1.
P910023|S051|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2001|03/02/2001|||APPR|APPROVAL FOR THE PROGRAMMER SOFTWARE MODEL 3307 V2.1.
P000018|S008|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/02/2001|10/26/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE STERILE BAG AND FLUID COLLECTION BAG PROVIDED IN THE PROCEDURE ACCESSORY PACK.
P980016|S016|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276||CV|Normal 180 Day Track|Express GMP Supplement|N|02/05/2001|05/25/2001|||APPR|APPROVAL FOR AN ALTERNATE FACILITY FOR THE MANUFACTURING, PACKAGING, AND STERILIZATION OF THE MODEL 7227CX, MODEL 7275, MODEL 7231, AND MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS LOCATED AT MEDTRONIC S.A., TOLOCHENAZ, SWITZERLAND.
P920015|S021|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/2001|06/11/2001|||APPR|APPROVAL FOR THE MODEL 6996 SQ LEAD SYSTEM AND THE 6996T TUNNELING TOOL.  THE MODEL 6996 SQ LEAD SYSTEM IS FOR SINGLE, LONG-TERM SUBCUTANEOUS USE AND IS INTENDED FOR USE IN PATIENTS IN WHICH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) ARE INDICATED.  THE LEAD IS INTENDED FOR USE IF A STANDARD ICD SYSTEM WITH ONE OR TWO TRANSVENOUS LEADS HAS NOT BEEN EFFICACIOUS IN PROVIDING ACCEPTABLE DFT MEASUREMENTS.  THE MODEL 6996 SQ LEAD IS INTENDED FOR USE ONLY WITH THE FOLLOWING SYSTEMS: A MEDTRONIC ICD FEATURING A CONNECTOR BLOCK WITH AT LEAST TWO DF-1 CONNECTOR PORTS; AND A MEDTRONIC RIGHT VENTRICULAR LEAD FOR DEFIBRILLATING/PACING/SENSING.  IN ADDITION, A THIRD DEFIBRILLATION LEAD, SUCH AS ANY MEDTRONIC SVC LEAD, MAY BE USED WITH A LEAD ADAPTOR.
P900061|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276|LWS|CV|Normal 180 Day Track|Express GMP Supplement|N|02/05/2001|05/25/2001|||APPR|APPROVAL FOR AN ALTERNATE FACILITY FOR THE MANUFACTURING, PACKAGING, AND STERILIZATION OF THE MODEL 7227CX, MODEL 7275, MODEL 7231, AND MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS LOCATED AT MEDTRONIC S.A., TOLOCHENAZ, SWITZERLAND.
P980050|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276|LWS|CV|Normal 180 Day Track|Express GMP Supplement|N|02/05/2001|05/25/2001|||APPR|APPROVAL FOR AN ALTERNATE FACILITY FOR THE MANUFACTURING, PACKAGING, AND STERILIZATION OF THE MODEL 7227CX, MODEL 7275, MODEL 7231, AND MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS LOCATED AT MEDTRONIC S.A., TOLOCHENAZ, SWITZERLAND.
P970020|S030|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX AND OTW PIXEL CORONARY STENT SYSTEMS|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2001|06/01/2001|||APPR|APPROVAL FOR THE ACS MULTI-LINK CORONARY STENT SYSTEMS.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING:  PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <25 MM) WITH REFERENCE DIAMETERS FROM 2.0 TO 2.5 MM.  LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P930016|S013|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S2/S3 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/2001|03/19/2001|||APPR|APPROVAL TO ADD AN 8 MM BLEND ZONE THAT INCREASES THE OVERALL DIAMETER OF THE ABLATION ZONE FROM 6.5 TO 8.0 MM.
P900056|S060|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTALINK ROTATIONAL ANGIOPLASTY SYSTEM AND ROTALINK(TM) PLUS WITH EXCHANGEABLE CATHETER|MCX|CV|Normal 180 Day Track|Express GMP Supplement|N|02/06/2001|03/21/2001|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORK LTD. (BSCL), CORK, IRELAND AND A STERILIZATION FACILITY LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND.
P990037|S003|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369|||VASCULAR SOLUTIONS DUETT MODEL 1000 SEALING DEVICE||CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/07/2001|03/22/2001|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTINOS FOR USE MANUAL TO INCLUDE THE OUTCOME DATA (REGISTRY RESULTS) REGARDING PATIENTS TREATED WITH PLATELET GP IIB/IIIA INHIBITORS.
P000018|S009|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|Normal 180 Day Track|Other Report|N|02/12/2001|10/26/2001|||APPR|APPROVAL FOR THE REVISED SOURCE SEED SPECIFICATION (2.7 - 40 MCI) FOR THE BETA-CATH SYSTEM.
P990036|S001|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014||Intravascular radiation delivery system|CORDIS CHECKMATE SYSTEM|MOU|CV|Normal 180 Day Track||N|02/13/2001|06/13/2002|||APPR|APPROVAL FOR A MODIFICATION TO THE EXISTING RADIATION DOSIMETRY PROTOCOL FROM A PROTOCOL THAT IS BASED ON INTRAVASCULAR ULTRASOUND (IVUS) TO A PROTOCOL THAT PRESCRIBES A FIXED DOSE OF 14 GY AT A DISTANCE OF 2 MM FROM THE CENTERLINE OF THE SOURCE AND IS INDICATED FOR THE TREATMENT OF NATIVE CORONARY ARTERIES (2.75 - 4.0 MM IN DIAMETER AND LESIONS UP TO AND INCLUDING 45 MM IN LENGTH) WITH IN-STENT RESTENOSIS FOLLOWING PERCUTANEOUS REVASCULARIZATION USING CURRENT INTERVENTIONAL TECHNIQUES.
P930038|S030|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL(TM) VASCULAR CLOSURE DEVICE, 8F/6F|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2001|03/12/2001|||OK30|REMOVAL OF THE HEPA WORK STATIONS IN THE PUERTO RICO MANUFACTURING FACILITY AND TO CHANGE THE ENVIRONMENTAL MONITORING PROCEDURE FROM A QUARTERLY PROCESS TO A MONTHLY PROCESS.
P000018|S010|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH(TM) SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2001|03/09/2001|||OK30|CHANGE IN THE MANUFACTURING METHOD USED IN CUTTING THE DELIVERY CATHETER, FROM A MANUAL TO AN AUTOMATED PROCESS.
P970004|S012|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM(R) THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/20/2001|08/06/2001|||APPR|APPROVAL FOR THE MODEL 3031A PATIENT PROGRAMMER FOR USE WITH THE MEDTRONIC(R) INTERSTIM(R) THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE, URINARY RETENTION, AND SIGNIFICANT SYMPTOMS OF URGENCY/FREQUENCY IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
P970035|S024|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2001|03/19/2001|||OK30|CHANGE FROM AN OIL-BASE COOLANT USED DURING RING MACHING PROCESS TO A WATER-BASE COOLANT, AND PROPOSES TO CHANGE THE ALCOHOL AND HFE SOLVENT CLEANER USED DURING RING MACHINING TO A WATER-BASE CLEANING SOLUTION FOR BOTH THE S670 AND S660 PRODUCTS.
P960004|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE II/FINELINE II STEROX PACING LEADS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/20/2001|04/06/2001|||APPR|APPROVAL FOR THE USE OF MANNITOL AS AN ALTERNATE MATERIAL TO COVER THE HELIX ON THE ABOVE REFERENCED ACTIVE FIXATION PACING LEADS.  THE DEVICES ARE INDICATED FOR PERMANENT PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
P970008|S016|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2001|12/06/2001|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT UROLOGIX, INC., MINNEAPOLIS, MINNEAPOLIS.
P950005|S011|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/2001|06/27/2001|||APPR|APPROVAL FOR CHANGES IN THE SCREWING MECHANISM OF THE REDEL CONNECTOR AND THE VENT HOLE PLACEMENT IN THE CELSIUS(TM) CATHETER.
P000018|S011|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE(TM) BETA-CATH(TM) SYSTEM|MOU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2001|08/22/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE PROXIMAL MARKER OF THE SOURCE TRAIN.
P970035|S025|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S670 AND S660 WITH DISCRETE TECHNOLOGY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2001|03/19/2001|||OK30|OPTION TO USE AN AUTOMATED FILLING AND EVACUATING COATING CHAMBER, THAT THEN AUTOMATICALLY TRANSFERS THE CATHETERS TO THE CURING CHAMBER.
P000022|S004|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|BESTENT 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2001|03/19/2001|||OK30|OPTION TO USE AN AUTOMATED FILLING AND EVACUATING COATING CHAMBER, THAT THEN AUTOMATICALLY TRANSFERS THE CATHETERS TO THE CURING CHAMBER.
P890057|S014|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)|LSZ|AN|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/2001|09/24/2001|01M-0520|11/19/2001|APPR|APPROVAL FOR THE MODEL 3100B HFOV.  THE DEVICE IS INDICATED FOR USE IN THE VENTILATORY SUPPORT AND TREATMENT OF SELECTED PATIENTS 35 KILOGRAMS AND GREATER WITH ACUTE RESPIRATORY FAILURE.
P900061|S043|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC VISION SOFTWARE SERIES 4.0|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2001|03/15/2001|||APPR|APPROVAL FOR THE PROGRAMMING SOFTWARE TO BE USED WITH THE MEDTRONIC GEM (MODEL 9962 SOFTWARE) ICD SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OF MEDTRONIC VISION SOFTWARE SERIES 4.0.
P980016|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC VISION SOFTWARE SERIES 4.0||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2001|03/15/2001|||APPR|APPROVAL FOR THE PROGRAMMING SOFTWARE TO BE USED WITH THE MEDTRONIC GEM DR (MODEL 9960 SOFTWARE), GEMII VR (MODEL 9965 SOFTWARE), AND GEM II DR (MODEL 9964 SOFTWARE) ICD SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OF MEDTRONIC VISION SOFTWARE SERIES 4.0.
P970004|S013|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2001|08/17/2001|||APPR|APPROVAL FOR THE MODEL 3550-03 TWIST-LOCK SCREENING CABLE AND MODEL 3550-05 PERCUTANEOUS EXTENSION AND TUNNELING TOOL KIT FOR TEMPORARY SACRAL NERVE STIMULATION AS PART OF A STAGED IMPLANT TECHNIQUE FOR THE MEDTRONIC(R) INTERSTIM(R) THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE, URINARY RETENTION, AND SIGNIFICANT SYMPTOMS OF URGENCY-FREQUENCY IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
P920014|S015|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE XVE LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2001|05/31/2001|||APPR|APPROVAL TO INCLUDE THE HEARTMATE. XVE LVAS UNDER P920014, WITH THE SAME INDICATIONS FOR USE AS FOR THE PREVIOUSLY APPROVED (IN SUPPLEMENT S7, APPROVAL LETTER DATED OCTOBER 6, 1998) VE LVAS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEARTMATE. XVE LVAS AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE.  THE HEARTMATE. SVE LVAS IS INDICATED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.
P950037|S019|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|HOME MONITORING SYSTEM|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/2001|10/11/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE HARDWARE AND SOFTWARE, INCLUDING:  1) THE ADDITION OF A LOW-POWER, RADIOFREQUENCY (RF) TRANSMITTER TO THE IMPLANTABLE PULSE GENERATOR (IPG);  2) MODIFICATION OF THE IPG SOFTWARE TO PERMIT RF TRANSMISSION OF PATIENT AND DEVICE DATA FROM THE IPG;  3) THE ADDITION OF A CELL-PHONE-LIKE PATIENT DEVICE THAT RECEIVES RF DATA TRANSMITTED BY THE IPG THEN FORWARDS THE DATA TO ABIOTRONIK SERVICE CENTER VIA A CELLULAR TELEPHONE DIGITAL DATA TRANSMISSION SERVICE; AND 4) MODIFICATION OF THE PROGRAMMER SOFTWARE TO PERMIT PROGRAMMING OF THESE NEW IPG CAPABILITIES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HOME MONITORING SYSTEM, INCLUDING MODEL BA03 DDDR PULSE GENERATOR, MODEL RUC 200 PATIENT DEVICE, AND MODEL B-KT0.0.A PROGRAMMER SOFTWARE, AND IS INDICATED FOR PATIENTS WITH THE FOLLOWING CONDITIONS:  RATE-ADAPTIVE PACING WITH THE BA03 DDDR PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.  GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO:  SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. PATIENTS WHOM DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL-CHAMBER OR ATRIAL PACING MODES.  DUAL-CHAMBER MODES ARE SPECIFICALLY INDICTED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.  ADDITIONAL INDICATIONS INCLUDE: NORMAL SINUS RHYTHM AND NORMAL A-V CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT.  NOTE: PATIENTS WITH KNOWN PAROXYSMAL ATRIAL...
P980046|S004|HOME ACCESS HEALTH CORP.|2401 W. HASSELL|SUITE 1510|HOFFMAN ESTATES|IL|60195|5200|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|HOME ACCESS HEPATITIS C CHECK TEST|MZO|MI|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2001|03/21/2001|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT HOME ACCESS HEALTH CORPORATION, HOFFMAN ESTATES, ILLINOIS.
P980009|S006|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT ENDOPROSTHESIS|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2001|03/16/2001|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC IRELAND LTD., GALWAY, IRELAND.
P900023|S035|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2001|03/15/2001|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT ABIOMED, INC., DANVERS, MASSACHUSETTS.
P960040|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM IMPLANTABLE CARIOVERTER DEFIBRILLATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/26/2001|04/05/2001|||APPR|APPROVAL FOR VENTAK(R) PRIZM(TM) MODEL 2844 SOFTWARE APPLICATION, VERSION 3.3.
P950018|S005|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2001|03/27/2001|||OK30|TO ELIMINATE THE WATER CONTENT TESTING AND THE ODOR CHECK ON THE PERFLUORO-N-OCTANE RAW MATERIAL.
P970007|S002|Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK|IL|60064||ENZYME IMMUNOASSAY, TRACROLIMUS|IMX TACROLIMUS II|MLM|TX|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/27/2001|03/30/2001|||APPR|APPROVAL FOR A CHANGE TO THE CURRENT LABELING FOR THE DEVICE PER 21 CFR 814.39(D)(2).  THE CURRENT PACKAGE INSERT STATES "HEMATOCRIT VALUES RANGING FROM 25 TO 45% RESULTED IN LESS THAN 12% ERROR IN DETECTING TACROLIMUS."  THE PACKAGE INSERT WILL BE MODIFIED TO STATE "HEMATOCRIT INTERFERENCE WAS EVALUATED BY SPIKING KNOWN AMOUNTS OF TACROLIMUS INTO POOLED, WHOLD BLOOD SAMPLES DILUTED WITH SALINE.  HEMATOCRIT VALUES RANGING FROM 25 TO 45% RESULTED IN LESS THAN 31% ERROR IN DETECTING TACROLIMUS.
P860019|S169|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2001|03/27/2001|||OK30|CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.
P880027|S058|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2001|03/27/2001|||OK30|CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.
P880065|S005|Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||PULSE-GENERATOR, PROGRAM MODULE|AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER|LOT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2001|03/27/2001|||OK30|CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.
P970061|S010|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||RADIUS(TM) CORONARY STENT WITH DELIVERY SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2001|03/27/2001|||OK30|CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.
P980001|S029|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR(R) PREMOUNTED STENT DELIVERY SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2001|03/27/2001|||OK30|CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.
P990009|S006|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX/MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/02/2001|04/30/2001|||APPR|APPROVAL FOR THE ADDITION OF LANGUAGE TO THE PACKAGE INSERT REGARDING THE USE OF FLOSEAL(R) MATRIX AND PROCEED(TM) HEMOSTATIC SEALANTS AS AGENTS FOR NASAL/SINUS BLEEDING.
P830037|S044|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|PHEMFILCON A SOFT (HYCROPHILIC) CONTACT LENS|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2001|09/14/2001|||APPR|APPROVAL FOR A MATERIAL CHANGE TO INCORPORATE THE USE OF A DIFFERENT ADHESION PROMOTER TO BE USED IN THE PIGMENT APPLICATION PROCESS.
P990020|S007|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/2001|05/09/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE DELIVERY CATHETER FOR THE 28 MM ANEURX STENT GRAFT SYSTEM.
P860003|S039|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR(R) XTS(TM) PHOTOPHERESIS SYSTEM|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2001|05/22/2001|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS RELATED TO THE ENUMERATION OF BUFFY COAT MODE CYCLES AND TO THE COLLECTION VOLUME OF BUFFY COAT PRIOR TO THE IRRADIATION PROCESS.
P000014|S001|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2001|03/20/2001|||OK30|CHANGE TO TEST AND RELEASE LIMITS THAT ARE APPLIED TO THE RESULTS FROM IN-HOUSE CONTROLS USED DURING THE TESTING AND RELEASE PROCESS FOR THIS PRODUCT.
P990009|S007|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX HEMOSTATIC SEALANT|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2001|04/10/2001|||APPR|APPROVAL FOR THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" FOR FLOSEAL MATRIX(R) HEMOSTATIC SEALANT.
P880086|S083|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/2001|07/11/2001|01M-0462|10/11/2001|APPR|APPROVAL FOR THE INTEGRITY AFX DR MODEL 5346 PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A.  THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: 1)SYNCOPE 2) PRESYNCOPE  3) FATIGUE  4) DISORIENTATION  5) OR ANY COMBINATION OF THOSE SYMPTOMS.  RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.  DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING:  1) SICK SINUS SYNDROME  2) CHRONIC, SYMPTOMATIC SECOND- AND THIRD DEGREE AV BLOCK  3) RECURRENT ADAMS-STOKES SYNDROME  4) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND:  1) NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST  2) CHRONIC ATRIAL FIBRILLATION  3) SEVERE PHYSICAL DISABILITY.  DYNAMIC ATRIAL OVERDRIVE IS INDICATED FOR SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS INCLUDING PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P830045|S076|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE|KRG|CV|Panel Track|Change Design/Components/Specifications/Material|N|03/08/2001|07/11/2001|01M-0461|10/11/2001|APPR|APPROVAL FOR THE INTEGRITY AFX DR MODEL 5346 PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A.  THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: 1)SYNCOPE 2) PRESYNCOPE  3) FATIGUE  4) DISORIENTATION  5) OR ANY COMBINATION OF THOSE SYMPTOMS.  RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.  DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING:  1) SICK SINUS SYNDROME  2) CHRONIC, SYMPTOMATIC SECOND- AND THIRD DEGREE AV BLOCK  3) RECURRENT ADAMS-STOKES SYNDROME  4) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND:  1) NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST  2) CHRONIC ATRIAL FIBRILLATION  3) SEVERE PHYSICAL DISABILITY.  DYNAMIC ATRIAL OVERDRIVE IS INDICATED FOR SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS INCLUDING PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P950002|S009|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM|MAX|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/2001|04/03/2001|||APPR|APPROVAL FOR A CHANGE TO THE LABELING OF THE BAK INTERBODY FUSION SYSTEM ADDING A PRECAUTION STATEMENT (IE., THE BAK/PROXIMITY DEVICE IS TO BE USED ONLY IN CONJUNCTINO WITH A STANDARD BAK DEVICE.  THE SAFETY AND EFFECTIVENESS OF THE BAK/PROXIMITY DEVICE HAS NOT BEEN ESTABLISHED WHEN USED OTHERWISE.) EFFECTIVE APRIL 1, 2001.
P980040|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|03/08/2001|04/18/2001|||APPR|APPROVAL FOR THE ACRYLIC SHEET CASTING AND BUTTON FABRICATION MANUFACTURING PROCESSES TO BE PERFORMED AT A.M.O. PUERTO RICO, INC., ANASCO, PUERTO RICO.
P950039|S007|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP(R) 2000 SYSTEM|MKQ|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/23/2001|08/06/2001|||APPR|APPROVAL TO INCLUDE IN THE CURRENT PACKAGE INSERT, DATA AND INFORMATION FROM A DIRECT-TO-VIAL CLINICAL STUDY FOR HIGH GRADE SQUAMOUS INTRAEPITHELIAL AND MORE SEVERE LESIONS.
P990052|S003|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT D SOUNDBRIDGE SYSTEM|MPV|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/2001|04/02/2001|||APPR|APPROVAL TO CHANGE THE HINGE BOSS AND TO CHANGE THE NEGATIVE BATTERY CONTACT.  THE INDICATINOS FOR UE FOR THE DEVICE HAVE NOT CHANGED.
P000018|S012|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE(TM) BETA-CATH(TM) SYSTEM|MOU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2001|08/01/2001|||APPR|APPROVAL FOR AN ALTERNATE METHOD OF RECEIPT AND ASSEMBLING OF SOURCE TRAINS.
P990048|S002|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||SYSTEM, LASER, PHOTODYNAMIC THERAPY|VISULAS 690S LASER AND VISULINK PDT ADAPTER|MVF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/2001|07/03/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE VISULINK PDT ADAPTER IN ORDER TO MAKE THE VISULAS 790S LASER COMPATIBLE WITH BOTH ZEISS AND HAAG STREIT SLIT LAMPS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULINK PDT/U ADAPTER AND  IS INDICATED FOR USE WITH THE VISULAS 690S LASER  THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE(VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION (AMD) IN PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION( CNV).
P920004|S015|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL ES AND VHD DEVICES|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/2001|09/20/2001|||APPR|APPROVAL TO MODIFY LANGUAGE IN THE INSTRUCTIONS FOR USE (IFU) FOR THE VASOSEAL EA AND VASOSEAL VHD DEVICES TO ADD CLINICAL STUDY DATA TO THE LABELING FOR BOTH DEVICES IN SUPPORT OF A NEW CLAIM FOR REDUCED TIME-TO-DISCHARGE FOR DIAGNOSTIC ANGIOGRAPHY PATIENTS AND TO EXPAND THE INDICATIONS FOR USE FOR THE VASOSEAL VHD DEVICE FROM BALLOON ANGIOPLASTY OR STENT PROCEDURES TO THE GENERAL CATEGORY OF INTERVENTIONAL PROCEDURES.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES VASOSEAL ES AND VASOSEAL VHD AND THE VASSEAL VHD IS INDICATED FOR USE IN SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND RETROGRADE APPROACH.  THE VASOSEAL VHD REDUCES TIME TO HEMOSTASIS, AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES.  IN ADDITION, THE VASOSEAL VHD REDUCES TIME TO DISCHARGE IN DIAGNOSTIC PATIENTS.  THE VASOSEAL VHD ALSO REDUCES TIME TO HEMOSTASIS IN INTERVENTIONAL PATIENTS, WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED.  HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DEMONSTRATED.
P980001|S030|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2001|04/10/2001|||OK30|EMODIFICATION TO THE ACCEPTANCE CRITERIA FOR THE GEL LUMP SIZE TO THE SOX(TM) COMPONENT FROM 0.005" TO <= 0.010".
P980001|S031|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2001|04/10/2001|||OK30|CHANGE IN THE MANUFACTURING PROCESS BY USING SCRAPPED MATERIAL IN THE FINAL FUNCTIONAL TESTING FOR THE SOX(TM) COMPONENT TO MINIMIZE THE AMOUNT OF DESTROYED PRODUCT AT FINAL TESTING.
P000014|S002|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2001|08/29/2001|||APPR|APPROVAL TO CHANGE THE TEST RELEASE LIMITS APPLIED TO THE OUTPUT OF THAT MODEL FOR THE VITROS ANTI-HBS ASSAY.
P980053|S003|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/2001|04/02/2001|||APPR|APPROVAL TO REVISE LABELING'S DIRECTIONS FOR USE TO ADD INSTRUCTIONS FOR INJECTION OF DURASPHERE(R) VIA A PERIURETHRAL ROUTE.
P960052|S002|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND TOPICAL SKIN ADHESIVE (2-OCTYL CYANOACRYLATE)|MPN|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/2001|04/04/2001|||APPR|APPROVAL TO MODIFY THE LABELING IN ORDER TO CLARIFY THE INSTRUCTIONS FOR PREPARING AND STORING THE DEVICE.
P860019|S170|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK MONORAIL|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2001|04/05/2001|||OK30|CHANGES IN THE MANUFACTURING PROCESS FOR THE MAVERICK MONORAIL PRODUCT LINE TO INCLUDE THE USE OF A NON-TAPERED PRODUCTION MANDREL WITH BLUNT ENDS, AND ADDITIONAL PREVENTIVE MEASURES TO ENSURE THAT A THIN WALL CONDITION DOES NOT OCCUR IN THE INFLATION LUMEN, ICLUDING THE ADDITION OF A 100% VACUUM DECAY TEST FOR BOTH THE MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS.
P970013|S001|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY II SR MODEL 2525T/MICRONY K SR MODEL 2535K PULSE GENERATORS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/2001|04/30/2001|||APPR|APPROVAL FOR MICRONY II SR+ MODEL 2525T AND MICRONY K SR MODEL 2535K PULSE GENERATORS.
P900056|S061|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2001|04/13/2001|||OK30|CHANGE IN THE VENDOR FOR WATER FOR INJECTION (WFI) WHICH IS A COMPONENT OF THE ROTAGLIDE(TM) LUBRICANT AND IS USED IN THE ROTABLATOR SYSTEM.  FRESENIUS KABI WILL PRODUCE WFI AT THEIR FACILITY IN ACCORDANCE WITH USP SPECIFICATIONS.
P970053|S006|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/2001|09/04/2001|||APPR|APPROVAL TO MODIFY THE APPROVED CLAIM FOR THE EC-5000 EXCIMER LASER SYSTEM TO ALLOW FOR THREATMENTS USING AN OPTICAL ZONE SIZE OF 5.5 MM TO 6.5 MM, IN ADDITION TO THE APPROVED OPTICAL ZONE SIZE OF T.T MM, FOR LASIK TREATMENT OF MYOPIA AND MYOPIA WITH ASTIGMATISM.  THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME NIDEK EC-5000 EXCIMER LASER SYSTEM AND REMAINS INDICATED FOR THE REDUCTION OR ELIMINATION OF -1.00 D TO -14.00 D MYOPIA SPHERICAL EQUIVALENT WITH OR WITHOUT <=-4 D ASTIGMATISM.
P810046|S206|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|OPEN SAIL CORONARY DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2001|04/13/2001|||OK30|CHANGE TO MODIFY THE SIDEARM ASSEMBLY AND INSPECTION PROCESS.
N17511|S014|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON HYSTEROSCOPY FLUID|LTA|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2001|08/17/2001|||APPR|APPROVAL FOR THE ADDITION OF A NEW WATER FOR INJECTION(WFI) GENERATION SYSTEM FOR THE WFI COMPONENT OF THE HYSKON(R) HYSTEROSCOPY FLUID.
P970051|S015|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11=11=2M DOUBLE ARRAY COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/2001|06/06/2002|||APPR|APPROVAL FOR THE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11+11+2M DOUBLE ARRAY COCHLEAR IMPLANT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH 11+11+2M DOUBLE ARRAY AND IS INDICATED FOR PATIENTS WHO HAVE COCHLEAR OSSIFICATION PREVENTING FULL INSERTION OF A STANDARD NUCLEUS 24 COCHLEAR IMPLANT ELECTRODE ARRAY.
P970003|S031|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2001|05/01/2001|||APPR|APPROVAL FOR THE NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM MODEL 300 NCP BIPOLAR LEAD (SINGLE RIBBON ELECTRODE).
P930038|S031|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/20/2001|08/28/2001|||APPR|APPROVAL FOR ADDING THE LOCKING CAP FEATURE ONTO THE DELIVERY SYSTEM OF THE ANGIO-SEAL VASCULAR CLOSURE DEVICE WITH SELF-TIGHTENING SLIPKNOT (STS).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND IS INDICATED FOR CLOSING AND REDUCING THE TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHIC PROCEDURES OR INTERVENTIONAL PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH FOR THE 8F ANGIO-SEAL DEVICE AND A 6 FRENCH OR SMALLER PROCEDURAL SHEATH FOR THE 6F ANGIO-SEAL DEVICE.
P900043|S027|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/2001|09/21/2001|||APPR|APPROVAL FOR THE ELECTIVE INDICATION AS SPECIFIED:  FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<=30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 TO 5.0 MM.
P000014|S003|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2001|04/19/2001|||OK30|CHANGE TO THE TYPE OF DISPENSER USED TO DISPENSE THE COATING SOLUTION AND WASH BUFFERS DURING THE MANUFACTURING OF THE COATED MICROWELLS, A COMPONENT OF THE PRODUCT.
P940034|S012|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121|||GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST||MI|Normal 180 Day Track|Other Report|N|03/02/2001|08/30/2001|||APPR|APPROVAL FOR CHANGES TO THE PACKAGE INSERT IN LIEU OF A POST-MARKETING STUDY.  THE CHANGES INCLUDE ADDITION OF INTERPRETIVE CRITERIA FROM THE CENTER FOR DISEASE CONTROL AND PREVENTION'S JULY 7, 2000, MMWR "UPDATE: NUCLEIC ACID AMPLIFICATION TEST FOR TUBERCULOSIS" AND THE CHANGE OF A PRECAUTION STATEMENT CONCERNING NEGATIVE TEST RESULTS TO A WARNING STATEMENT.  THESE CHANGES WILL BE PROVIDED IN A TECHNICAL BULLETIN THAT WILL ACCOMPANY THE PACKAGE INSERT FOR THE NEXT 4-6 MONTHS UNTIL THE NEXT PRINTING OF THE PACKAGE INSERT.
P840068|S041|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR SOFTWARE APPLICATION; VERSION 5.2|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2001|04/30/2001|||APPR|APPROVAL FOR THE VIGOR MODEL 2880 V5.2 SOFTWARE.
P940031|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR SOFTWARE APPLICATION; VERSION 5.2|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2001|04/30/2001|||APPR|APPROVAL FOR THE VIGOR MODEL 2880 V5.2 SOFTWARE.
P970003|S032|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/23/2001|05/10/2001|||APPR|APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERITEC, INC., ATHENS, TEXAS, AS WELL AS LABELING PROCESS AND PACKAGING CHANGES, AND A COMBINED MODEL PHYSICIAN'S MANUAL.
P920047|S014|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134|||EPT-1000 CARDIAC ABLATION SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2001|04/24/2001|||OK30|CHANGES IN THE MANUFACTURING OPERATION: A CHANGE IN THE WELDING PROCESS FROM A MANUAL TO AN AUTOMATED PROCESS, A CHANGE IN THE GRIT BLAST MEDIA, AND REMOVAL OF A CHEMICAL TO THE WELD JOINT.
P970034|S008|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/2001|12/31/2001|||APPR|APPROVAL FOR MODEL UB55AC POSTERIOR CHAMBER INTRAOCULAR LENS.
P810002|S056|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2001|05/03/2001|||APPR|APPROVAL FOR CHANGES TO THE COUNTRY OF ORIGIN OF THE BOVINE COLLAGEN USED FOR THE HEMASHIELD(R) GRAFT, WHICH IS A COMPONENT OF THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE - MASTER SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-51400 IN SIZES 19, 21, 23, 25, 27, 29, 31, AND 33 MM, AND IS INDICATED FOR THE REPLACEMENT OF THE AORTIC VALVE AND THE ASCENDING AORTA.
P000014|S004|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATORS|LOM|MI|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2001|04/19/2001|||APPR|APPROVAL FOR THE SHIPPING CONTAINERS, WHEN USED AS STATED, TO MAINTAIN A TEMPERATURE WITHIN THE RANGE OF 2 TO 20 DEGREES CELCIUS.
P960025|S006|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE SYSTEM|MCV|OR|Normal 180 Day Track|Other Report|N|03/27/2001|05/14/2001|||APPR|APPROVAL FOR THE FOLLOWING FOUR CHANGES TO THE INVESTIGATIONAL PLAN (IP) FOR THE POSTAPPROVAL STUDY:  1) THE USE OF ADDITIONAL PEDICLE SCREW SPINAL SYSTEMS WITH THE I/F CAGE COMPONENT, I.E., TO ALLOW FOR TH EUSE OF THE TI ALLOY VERSION OF THE VSP SPINE SYSTEM, THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE ISOLA SPINE SYSTEM, THE TIMX SPINE SYSTEM AND THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE MOSS MIAMI SPINE SYSTEM IN ADDITION TO THE STAINLESS STEEL VERSION OF THE VSP SPINE SYSTEM;  2) A CHANGE IN THE NAME OF THE DEVICE SYSTEM TO BE EVALUATED IN THE POSTAPPROVAL STUDY TO BE CONSISTENT WITH THE RECENTLY APPROVED DEVICE SYSTEM NAME CHANGE;  3) A MODIFICATION OF THE INTRA-OP CASE REPORT FORM TO ALLOW INVESTIGATORS TO RECORD WHICH PEDICLE SCREW SPINAL SYSTEM IDENTIFIED IN ITEM 1 ABOVE WAS ACTUALLY IMPLANTED; AND  4) A CHANGE TO THE REQUIRED RADIOGRAPHIC ASSESSMENT METHODS, I.E., THE OPTIONAL USE OF T1-WEIGHTED MRI AND DISCOGRAPHY.
P940008|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||INTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORS||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/2001|04/25/2001|||APPR|APPROVAL FOR LABELING CHANGES TO THE FOLLOW-UP INDICATORS REFLECTING BATTERY LONGEVITY.
P990055|S001|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS|NAF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/2001|12/07/2001|||APPR|APPROVAL FOR THE ADDITION OF THE ASSAY TO THE BAYER ACS:180 AND ADVIA CENTAUR ANALYZERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BAYER ACS:180 OR ADVIA CENTAUR COMPLEXED PSA ASSAY AND ARE INDICATED AS FOLLOWS:  THIS IN VITRO DEVICE IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM USING THE BAYER DIAGNOSTICS IMMUNO 1, THE ACS:180 SYSTEM, OR THE ADVIA CENTAUR SYSTEM.  THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER.
P840001|S051|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL(R) 3 AND SYNERGY(TM) SPINAL CORD STIMULATION SYSTEMS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/2001|07/31/2001|||APPR|APROVAL FOR THE MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION WHICH WILL BE USED WITH THE ITREL(R) 3 AND SYNERGY(TM) SPINAL CORD STIMULATION SYSTEMS.
P790017|S075|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2001|06/01/2001|||APPR|APPROVAL FOR THE R2L RAPID EXCHANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CATHETERS WITH EXTENDED PRESSURE RANGE.  THE DEVICES ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P980024|S001|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2001|12/31/2001|02M-0172|04/25/2002|APPR|APPROVAL FOR THE PATHVYSION HER-2 DNA PROBE KIT.  THIS DEVICE IS INDICATED TO DETECT AMPLIFICATION OF THE HER-2/NEU GENE VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS.  RESULTS FROM THE PATHVYSION KIT ARE INTENDED FOR USE AS AN ADJUNCT TO EXISTING CLINICAL AND PATHOLOGIC INFORMATION CURRENTLY USED AS PROGNOSTIC FACTORS IN STAGE II, NODE-POSITIVE BREAST CANCER PATIENTS.  THE PATHVYSION KIT IS FURTHER INDICATED AS AN AID TO PREDICT DISEASE-FREE AND OVERALL SURVIVAL IN PATIENTS WITH STAGE II, NODE POSITIVE BREAST CANCER TREATED WITH ADJUVANT CYCLOPHOSPHAMIDE, DOXORUBICIN, AND 5-FLUOROURACIL (CAF) CHEMOTHERAPY.  THE PATHVYSION KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT).
P900056|S062|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES|MCX|CV|Normal 180 Day Track|Express GMP Supplement|N|03/30/2001|04/17/2001|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC MIAMI TECHNOLOGY CENTER (BSMTC), MIAMI, FLORIDA.
P910001|S020|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2001|10/10/2001|||APPR|APPROVAL FOR AN ADDITIONAL INDICATION, THE TREATMENT OF RESTENOSIS IN 316L STAINLESS STEEL STENTS, PRIOR TO THE ADMINISTRATION OF INTRAVASCULAR BRACHYTHERAPY, FOR THE CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM.  THE INDICATION IS IN ADDITION TO THOSE LISTED IN THE FEBRUARY 19, 1993, APPROVAL LETTER.
N17752|S038|CIBA VISION CORPORATION|11460 JOHNS CREEK PARKWAY||DULUTH|GA|30097||Lenses, soft contact, daily wear|HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS|LPL|OP|Normal 180 Day Track|Express GMP Supplement|N|03/30/2001|08/16/2001|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT CIBA VISION (FORMERLY WESLEY JESSEN), CIDRA, PUERTO RICO.
P990046|S004|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/26/2001|06/14/2001|||APPR|APPROVAL FOR A SHELF LIFE EXTENSION FROM 3 YEARS TO 5 YEARS.
P990064|S005|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2001|11/21/2001|||APPR|APPROVAL FOR THE MOSAIC PORCINE BIOPROSTHESIS, MODEL 310 MITRAL, 33 MM.
P880003|S082|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|RAPTORAIL PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2001|09/27/2001|||APPR|APPROVAL FOR A NEW CATHETER MODEL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RAPTORAIL(TM) PTCA DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P890055|S012|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2001|04/24/2001|||APPR|APPROVAL FOR THE ADDITION OF:  1) AN OR PUMP HEATER (AP-09100) AND DRAPE (AP-09150) AS AN OPTION TO THE TRADITIONAL WATER BATH;  2) A MICROPIPETTE OR PREP KIT (AP-07004) FOR THE MEASUREMENT OF FLOW FROM THE IMPLANTABLE PUMP PRIOR TO IMPLANTATION; AND  3) ACCESSORIES TO THE INTRASPINAL KIT (AP-07009), INCLUDING AN ADDITIONAL NEEDLE AND BOTH WINGED AND TRADITIONAL CATHETER ANCHORS.
P970035|S026|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S670 WITH D OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS, S660 WITH DISCRETE TECH OVER-THE-WIRE AND RAPID EXS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2001|05/03/2001|||OK30|OPTION TO USE A LASER TO BOND THE MARKER BAND TO THE INNER-MEMBER OF THE CATHETERS.
P000022|S005|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2001|05/03/2001|||OK30|OPTION TO USE A LASER TO BOND THE MARKET BAND TO THE INNER-MEMBER OF THE CATHETERS.
P860019|S171|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2001|05/01/2001|||OK30|CHANGE TO ELIMINATE THE USE OF CREEP TESTING AND USE ONLY BURST TESTING AS A SINGLE STANDARD FOR DETERMINING PACKAGING SEAL STRENGTH INTEGRITY AT INCOMING INSPECTION AND ONLINE PRODUCTION.
P990066|S003|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/2001|04/24/2001|||APPR|APPROVAL FOR REVISED ACQUISITION WORKSTATION (AWS) MONITOR SPECIFICATIONS.
P900043|S028|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2001|09/21/2001|||APPR|APPROVAL FOR A NEW INDICATION (ELECTIVE STENTING OF DE NOVO AND RESTENOTIC CORONARY ARTERIES) AND ADDITIONAL STENT DIAMETERS (4.5 AND 5.0 MM) FOR THE BX VELOCITY WITH HEPACOAT ON  STENT SYSTEM.  THE DEVICE, AS MODIFIED, IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (= 30 MM IN LENGTH IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM; AND  2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM IN 4.00 MM.  THE 2.25 MM, 2.50 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
P950020|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON|LOX|CV|Normal 180 Day Track|Express GMP Supplement|N|04/06/2001|05/08/2001|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY LOCATED AT THE FRENCH VALLEY FACILITY, MURRIETA, CALIFORNIA.
P970015|S019|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE|MAX|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/09/2001|07/19/2001|||APPR|APPROVAL FOR USE OF DUAL INTERFIX-RP(TM) THREADED FURSION DEVICES (INSTEAD OF THE ALREADY APPROVED USE OF A SINGLE INTERFIX-RP(TM) THREADED FUSION DEVICE USED IN CONJUNCTION WITH AN INTERFIX(TM) THREADED FUSION DEVICE)  THE UNMODIFIED DEVICE WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME INTERFIX-RP(TM) THREADED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WTIH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL.  INTERFIX-RP(TM) THREADED FUSION DEVICES ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH.  PATIENTS RECEIVING THE INTERFIX-RP(TM) THREADED FUSION DEVICES SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INTERFIX-RP(TM) THREADED FUSION DEVICE.
P990053|S001|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|04/09/2001|10/05/2001|||APPR|APPROVAL FOR CHANGES TO THE POST APPROVAL STUDY PLAN.
P960052|S003|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND(R) TOPICAL SKIN ADHESIVE|MPN|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/2001|11/19/2001|||APPR|APPROVAL FOR THE ADDITION OF A STATEMENT IN THE LABELING THAT THE DEIVCE PROVIDES MICROBIAL BARRIER PROPERTIES.
P840001|S052|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 7421 ITREL(R) 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/2001|08/03/2001|||APPR|APPROVAL FOR A CHANGE IN THE INDICATIONS FOR USE FROM "CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS" TO "CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS".  THE INDICATION STATEMENT HAS BEEN REVISED TO STATE "THE MEDTRONIC [TRADE NAME] SYSTEM IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME OR HERNIATED DISC, POST-LAMINECTOMY PAIN, MULTIPLE BACK OPERATIONS, UNSUCCESSFUL DISC SURGERY, DEGENERATIVE DISC DISEASE (DDD)/HERNIATED DISC PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS, PERIPHERAL CAUSALGIA, EPIDURAL FIBROSIS, ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS, COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA."
P890003|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|9767/9767L PROGRAMMING HEAD AND MODEL9990 DESKTOP SOFTWARE|DXY|CV|Normal 180 Day Track||N|04/11/2001|05/07/2001|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9767/9767L PROGRAMMING HEAD AND MODEL 9990 DESKTOP SOFTWARE.
P970020|S031|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/2001|06/05/2001|||APPR|APPROVAL FOR THE ADDITION OF A NEW INDICATION FOR THE ACS MULTI-LINK RX AND OTW D, TRISTAR, ULTR TETRA CORONARY STENT SYSTEMS AND ACS MULTI-LINK. STENT AND THE FOUR DELIVERY SYSTEMS.  THE NEW ADDITIONAL INDICATION FOR THESE DEVICES IS FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH = 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM.
P860019|S172|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2001|05/02/2001|||OK30|ALTERNATE MANUFACTURING PROCESS FOR TRI-FORMING BALLOONS IN THE MANUFACTURE OF THE NC MAXXUM PTCA CATHETER SYSTEM USING THE SOFT V-BLADE BALLOON FORMER MACHINE.
P910066|S016|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS|LOF|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/2001|05/18/2001|||APPR|APPROVAL TO:  1)REFORMAT THE PATIENT MANUALS FOR THE OL 1000 AND OL 1000 SC BONE GROWTH STIMULATORS PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING,  2) REFORMAT THE PATIENT MANUAL FOR THE SPINALOGIC(TM) BONE GROWTH STIMULATOR PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING.
P980035|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC KAPPA 700/600 PULSE GENERATOR||CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2001|05/14/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPOXY APPLICATION PATTERN AND A WIRE BOND LOOP PROGRAM IN THE ABOVE REFERENCED FAMILY OF PULSE GENERATORS.
P860019|S173|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NC MONORAIL PTCA CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2001|05/16/2001|||APPR|APPROVAL FOR NC MONORAIL PTCA CATHETER WITH WRAP-IT ACCESSORY TOOL.  THE DEVICE, AS MODIFIED IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS BRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P900033|S005|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/2001|04/30/2001|||APPR|APPROVAL FOR A CHANGE IN THE TRADE NAME.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME INTEGRA(R) DERMAL REGENERATION TEMPLATE AND IS INDICATED FOR THE POST EXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL-THICKNESS THERMAL INJURY WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT.
P900043|S029|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM (RX)|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/13/2001|10/16/2001|||APPR|APPROVAL FOR THE BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<=30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM; AND  2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM.  THE 2.25 MM 2.5 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
P950005|S012|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS/CELSIUS II DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|Normal 180 Day Track|Express GMP Supplement|N|04/13/2001|05/25/2001|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY LOCATED AT BIOSENSE WEBSTER, INC., JUAREZ, CHIHUAHUA, MEXICO.
P980050|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/2001|05/22/2001|||APPR|APPROVAL FOR LABELING FOR THE MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR WHICH REFLECTS THE "AF ONLY" INDICATION (I.E., INDICATED FOR USE IN ICD PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS).
N50510|S145|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE|LTW|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2001|06/25/2001|||APPR|APPROVAL FOR CHANGES IN THE ANTIBIOTIC DESIGN SPECIFICATION FOR THE ANTIBIOTIC TRIMETHOPRIM/SULFAMETHOXAZOLE AT CONCENTRATIONS OF 2/38, 8/152, 16/304, AND 32/608 UG/ML TO THE VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK 2 AND IS INDICATED FOR USE IN VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE ISOLATES TO TRIMETHOPRIM/SULFAMETHOXAZOLE IN THE RANGE OF <= .5/9.5 TO >= 16/304 UG/ML.
P000022|S006|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RX CORONARY STENT DELIVERY SYSTEMS|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/2001|06/05/2001|||APPR|APPROVAL FOR THE UPDATED LABELING FOR THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE AND OVER-THE-WIRE CORONARY STENT DELIVERY SYSTEMS.
P840001|S053|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2001|08/06/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE MODEL 7495 AND MODEL 7495LZ EXTENSIONS.  THE FICILITY IS LOCATED AT MEDTRONIC NEUROLOGICAL PUERTO RICO OPERATIONS, VILLALBA, PUERTO RICO.
P990017|S015|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2001|08/17/2001|||APPR|REQUEST APPROVAL FOR CHANGING PLASTIC MACHINED COMPONENTS TO INJECTION-MOLDED COMPONENTS FOR THE DELIVERY CATHETER HANDLE AND CONTRALATERAL CUTTER.
P960009|S016|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL THERAPY SYSTEM|MHY|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2001|08/06/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE MODEL 7495 EXTENSION.  THE FICILITY IS LOCATED AT MEDTRONIC NEUROLOGICAL PUERTO RICO OPERATIONS, VILLALBA, PUERTO RICO.
P990017|S016|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2001|08/17/2001|||APPR|APPROVAL FOR CHANGES TO DELIVERY CATHETER IPSILATERAL CAPSULE AND CONTRALATERAL PULLWIRE.
P990074|S006|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Express GMP Supplement|N|04/17/2001|05/15/2001|||APPR|APPROVAL FOR MOVING THE MANUFACTURING AND DRY HEAT STERILIZATION OF SALINE-FILLED BREAST IMPLANTS TO MCGHAN MEDICAL CORPORATION, SANTA BARBARA, CALIFORNIA.
P900061|S044|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MICRO JEWEL/JEWEL II|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2001|05/14/2001|||APPR|APPROVAL FOR THE GENERAL USE INDICATION FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS MICRO JEWEL 7221, MICRO JEWEL II 7223, GEM DR 7271, GEM II DR 7273 AND GEM II VR 7229 AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
P980016|S018|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||GEM DR/GEM II DR/GEM II VR||CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2001|05/14/2001|||APPR|APPROVAL FOR THE GENERAL USE INDICATION FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS MICRO JEWEL 7221, MICRO JEWEL II 7223, GEM DR 7271, GEM II DR 7273 AND GEM II VR 7229 AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
P990017|S017|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2001|08/17/2001|||APPR|APPROVAL FOR LABELING CHANGES, INCLUDING USE OF STENTS AND GUIDEWIRES, AND JACKET RETRACTION TECHNIQUE.
P780010|S022|COOPERVISION, INC.|6150 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|04/18/2001|11/16/2001|||APPR|APPROVAL FOR A CHANGE IN INITIATOR FOR THE REFERENCED DEVICES MANUFACTURED AT AN ALTERNATE MANUFACTURING SITE LOCATED IN COOPERVISION, HUNTINGTON BEACH, CALIFORNIA.
P970034|S009|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|POSTERIOR CHAMBER IOL'S|HQL|OP|Normal 180 Day Track|Other Report|N|04/19/2001|06/29/2001|||APPR|APPROVAL FOR OPHTHALMIC INNOVATIONS INTERNATIONAL, INC. TO PRIVATE-LABEL ITS PMA-APPROVED POSTERIOR-CHAMBER INTRAOCULAR LENSES FOR DISTRIBUTION IN THE UNITED STATES BY CIBA VISION CORPORATION.  THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE-NAMES, CIBA VISION INTRAOCULAR LENS MODELS 0420F, 0455F, 0440U, 0840U, 0430M, 0840Z2, AND 0840Z, AND ARE INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER, WHO ARE UNDERGOING EXTRACAPSULAR EXTRACTION AND PRIMARY LENS IMPLANTATION.
P840024|S081|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2001|07/24/2001|||APPR|APPROVAL FOR THE CRYSTAL INTEGRITY TEST SYSTEM THAT PROVIDES A WAY OF PERFORMING A SERIES OF INTEGRITY CHECKS ON EITHER CURRENT OR PAST GENERATION NUCLEUS COCHLEAR IMPLANTS.
P890027|S050|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2001|07/24/2001|||APPR|APPROVAL FOR THE CRYSTAL INTEGRITY TEST SYSTEM THAT PROVIDES A WAY OF PERFORMING A SERIES OF INTEGRITY CHECKS ON EITHER CURRENT OR PAST GENERATION NUCLEUS COCHLEAR IMPLANTS.
P970051|S016|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2001|07/24/2001|||APPR|APPROVAL FOR THE CRYSTAL INTEGRITY TEST SYSTEM THAT PROVIDES A WAY OF PERFORMING A SERIES OF INTEGRITY CHECKS ON EITHER CURRENT OR PAST GENERATION NUCLEUS COCHLEAR IMPLANTS.
P790018|S037|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|HALL (TM) EASY-FIT PROSTHETIC HEART VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/19/2001|11/09/2001|||APPR|APPROVAL FOR THE HALL EASY-FIT PROSTHETIC HEART VALVE, MODELS A7700 (AORTIC) AND M7700 (MITRAL), AVAILABLE IN AORTIC SIZES 19, 21, 23, 25, 27, AND 29 MM, AND IN MITRAL SIZES 23, 25, 27, 29, AND 31 MM.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES.  THE HALL  PROSTHETIC HEART VALVE IS A MODIFICATION OF THE APPROVED MEDTRONIC HAL PROSTHETIC HEART VALVE; THE MODIFICATION CONSISTING OF A NEW SEWING CUFF MATERIAL AND DESIGN, INTENDED FOR SUPRA-ANNULAR PLACEMENT.  THE SUPPLEMENT ADDITIONALLY REQUESTED INTRODUCTION OF THE HALL E PROSTHETIC HEART VALVE PRODUCT LINE INTO THE APPROVED STEAM STERILIZATION PROCESS FOR THE MEDTRONIC H PROSTHETIC HEART VALVE.
P970058|S010|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER (CAD) SYSTEM, M1000|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2001|05/29/2001|||APPR|APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE TO COVER DIAGNOSTIC AS WELL AS SCREENING MAMMOGRAMS.  THE NEW INDICATIONS FOR USE IS:  THE IMAGECHECKER M1000 IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING AND DIAGNOSTIC MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P990026|S001|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2001|05/03/2001|||APPR|APPROVAL FOR THE ADDITION OF A PRESERVATIVE IN THE AUTOSENSORS.
P990014|S001|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|HYDROVIEW COMPOSITE HYDROGEL FOLDABLE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2001|10/19/2001|||APPR|APPROVAL TO USE THE SUREFOLD 1.5 PACKAGING FOR THE HYDROVIEW IOL.
P950018|S006|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2001|05/15/2001|||OK30|ELIMINATION OF REDUNDANT IN PROCESS TESTING FOR %PFNO, FLUORIDE ION, NON-VOLATILE RESIDUES AND HEAVY METALS.
P920032|S007|PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||PULSE-GENERATOR, PACEMAKER, EXTERNAL|BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170|DTE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/2001|10/26/2001|||APPR|APPROVAL FOR THE MODEL 4170 BEDSIDE SINGLE CHAMBER, EXTERNAL PULSE GENERATOR.  THE MODEL 4170 IS INDICATED FOR "ANY CLINICAL SITUATION IN WHICH THE USE OF TEMPORARY PACEMAKER ON A PATIENT PROVIDES THERAPEUTIC OR DIAGNOSTIC VALUE, OR SERVES A PROPHYLACTIC PURPOSE.  SPECIFICALLY, INDICATIONS FOR TEMPORARY PACEMAKERS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:  INTERMITTENT OR COMPLETE HEART BLOCK ASSOCIATED WITH ASYSTOLE OR BRADYCARDIA, SYMPTOMATIC SINUS BRADYCARDIA, SURGICALLY-INDUCED HEART BLOCK AND HEART BLOCK ACCOMPANYING AN ACUTE MYOCARDIAL INFARCTION."
P980048|S001|SULZER SPINE-TECH|7375 BUSH LAKE RD.||MINNEAPOLIS|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM|MAX|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2001|05/02/2001|||APPR|APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS ISOMEDIX SERVICES, MINNEAPOLIS, MINNESOTA.
P000018|S013|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH(TM) SYSTEM|MOU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2001|10/18/2001|||APPR|APPROVAL FOR MODIFICATION TO THE DESIGN OF THE TRANSFER DEVICE, THE ADDITION OF A TWIN TRANSPORT CASE TO THE TRANSPORT SYSTEM, A MODIFICATION TO THE SOURCE COLLECTION CONTAINER, AND A MODIFICATION TO THE FLUID COLLECTION BAG,K OF THE 30 MM AND 40 MM NOVOSTE BETA-CATH SYSTEMS.
P970020|S032|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2001|05/24/2001|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR STENT PRODUCTION.
P990027|S003|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS(R)217A OPHTHALMIC EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/2001|09/25/2001|||APPR|APPROVAL TO ADD AN ACTIVE EYETRACKER AS AN ACCESSORY TO THE LASER SYSTEM.
P970004|S014|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/2001|10/24/2001|||APPR|APPROVAL FOR LEAD MODELS 3092 AND 3966 FOR USE WITH THE MEDTRONIC(R) INTERSTIM(R) THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE, URINARY RETENTIOIN, AND SIGNIFICANT SYMPTOMS OF URGENCY-FREQUENCY IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
P000007|S001|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|04/27/2001|02/12/2002|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL TO ADDRESS THE ISSUE OF LONG-TERM CLINICAL EFFECTIVENESS OF THE EDWARDS XENOLOGIX ANTICALCIFICATION TREATMENT AS STIPULATED IN THE FEBRUARY 27, 2001 APPROVAL ORDER.
P980040|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTEROIR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/2001|10/24/2001|||APPR|APPROVAL FOR UPDATED ANTERIOR LENS TISSUE ONGROWTH LABELING.
P950032|S023|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF(R)|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/30/2001|05/09/2001|||APPR|APPROVAL TO INTRODUCE A NEW KERATINOCYTE CELL STRAIN INTO THE PRODUCTION OF APLIGRAF (I.E., HEP 663).
P900009|S013|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))|LPQ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/2001|09/04/2001|||APPR|APPROVAL FOR THE LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEM-SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTBLISHED NONUNIONS* EXLUDING SKULL AND VERTEBRA.  IN ADDITION, THE EXOGEN 2000+(TM) OR SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FRACTURE FOR FRESH, CLOSED, POSTERIORLY DISPLACED DISTAL RADIUS FRACTURES AND FRESH, CLOSED OR GRADE 1 OPEN TIBIAL DIAPHYSIS IN SKELETALLY MATURE INDIVIDUALS WHEN THESE FRACTURES ARE ORTHOPEDICALLY MANAGED BY CLOSED REDUCTION AND CAST IMMOBILIZATION.  * A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HEALING.
P900056|S063|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2001|05/21/2001|||OK30|TRANSFER OF THE BURR PLATING PROCESS TO THE BOSTON SCIENTIFIC CORK LTD. FACILITY.
P960052|S004|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY|MPN|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2001|12/31/2002|||APPR|APPROVAL FOR THE ADDITION OF A HIGHER VISCOSITY PRODUCT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE AND IS INTENDED FOR TOPICAL APPLICATION ONLY TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF WOUNDS FROM SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS.  HIGH VISCOSITY DERMABOND ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.
P990037|S005|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2001|10/31/2001|||APPR|APPROVAL FOR A MODIFIED CATHETER TO BE USED WITH THE DUETT MODEL 1000 SEALING DEVICE.
P970031|S010|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY, MODEL 995MS|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2001|10/31/2001|||APPR|APPROVAL FOR THE FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, AVAILABLE IN SIZES 19 MM, 21 MM, 23 MM, 25 MM, AND 27 MM.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P930031|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT(R) TRANSJUGLAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2001|05/29/2001|||OK30|CHANGE TO THE INTERNAL ACTION LEVEL FOR PARTICULATE COUNT OF FINISHED PRODUCT.
P940019|S007|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT(R) ILLIAC ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2001|05/29/2001|||OK30|CHANGE TO THE INTERNAL ACTION LEVEL FOR PARTICULATE COUNT OF FINISHED PRODUCT.
P000044|S001|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBS AG REAGENT PACK/CALIBRATOR/CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2001|05/24/2001|||OK30|CHANGE TO THE TYPE OF DISPENSER USED TO DISPENSE THE COATING SOLUTIO NAND WASH BUFFERS DURING THE MANUFACTURE OF THE COATED MICROWELLS, A COMPONENT OF THE PRODUCT.
P970020|S033|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2001|06/01/2001|||APPR|APPROVAL FOR A REPLACEMENT WHITE FOIL MARKER MATERIAL ON THE FOLLOWING  FAMILY OF CORONARY STENT SYSTEMS: MULTI-LINK TET, MULTI-LINK ULTR, MULTI-LINK PENTA AND MULTI-LINK PIX (CURRENTLY UNDER REVIEW).
P810046|S207|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|HIGHSAIL CORONARY DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2001|05/24/2001|||OK30|MANUFACTURING CHANGE TO MODIFY THE SIDEARM ASSEMBLY AND INSPECTION PROCESS.
P970003|S033|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/2001|06/07/2001|||APPR|APPROVAL FOR LABELING CHANGES.  THE CHANGES ARE INTENDED TO: 1) ADD A WARNING THAT RECOMMENDS THAT PHYSICIANS USE CARE WHEN TREATING PATIENTS WITH PRE-EXISTING OBSTRUCTIVE SLEEP APNEA (OSA), AND  2) ADD AND STRENGTHEN PRECAUTIONS REGARDING: A) ELECTROSURGERY, B) THERAPEUTIC ULTRASOUND, C) EXPOSURE TO ENVIRONMENTS THAT ARE PROTECTED BY A WARNING NOTICE PREVENTING ENTRY BY PATIENTS WITH AN IMPLANTED PACEMAKER, AND D) APPLICATION OF OTHER THERAPIES INVOLVING ELECTRIC CURRENT, SUCH AS TENS DEVICES.
P970040|S002|GE LUNAR CORP.|726 HEARTLAND TRAIL||MADISON|WI|53717||Bone sonometer|ACHILLES INSIGHT ULTRASONOMETER|MUA|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/07/2001|10/24/2001|||APPR|APPROVAL FOR:  1) THE ADDITION OF 2-D REAL TIME PREVIEW IMAGING;  2) A NEW RECEIVER TRANSDUCER ARRAY;  3) HIGHER CONTRAST COLOR LCD GRAPHICS AND IMAGING; AND  4) AN OPTIONAL LARGER SCREEN DISPLAY.
P980001|S032|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEMS||CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2001|05/29/2001|||APPR|APPROVAL FOR A REDUCTION OF THE INTERNAL DIAMETER OF THE PROXIMAL SHAFT FROM 0.0205" TO 0.0190" ON THE FOLLOWING PREMOUNTED STENT SYSTEMS: NOROYAL(TM) ADVANCE, NIROYAL(TM) ELITE AND NIR(TM) ELITE.
P860019|S174|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2001|05/25/2001|||APPR|APPROVAL FOR A REDUCTION OF THE INTERNAL DIAMETER OF THE PROXIMAL SHAFT FROM 0.0205" TO 0.0190" ON THE FOLLOWING CATHETERS: MAXXUM(TM), NC MAXXUM(TM) AND ADANTE(TM).
P990026|S002|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH (R) AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/08/2001|05/22/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE AUTOSENSOR PACKAGING.
P910023|S052|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|PHOTON MICRO(U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTW3|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/09/2001|06/13/2001|||APPR|APPROVAL FOR PHOTON(TM) MICRO (U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTWARE, V2.3. THESE DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTI-TACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P810046|S208|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CORONARY DILATATION CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2001|06/05/2001|||APPR|APPROVAL FOR MODIFICATIONS OF WHITE FOIL MARKERS IN THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), AND ACS ESPRIT PTCA CATHETERS.
P000046|S001|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|SHELLGEL(TM) SODIUM HYALURONATE|LZP|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/10/2001|06/11/2001|||APPR|APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH CYTOSOL OPHTHALMICS, INC.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SHELLGEL(TM) SODIUM HYALURONATE.
P940013|S007|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, daily wear|PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR|LPL|OP|Normal 180 Day Track|Express GMP Supplement|N|05/10/2001|10/04/2001|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITIES LOCATED AT CIBA VISION CORPORATION, ATLANTA, GEORGIA AND CIBA VISION BATAM, BATAM ISLAND, INDONESIA.
P970035|S027|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 WITH DIS OVER-THE WIRE CORONARY STENT SYSTEM AND S7 WITH DISCRETE TECHN RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2001|05/29/2001|||OK30|CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE LENGTH AND INNER DIAMETER OF THE THIRD AND FOURTH TFE BAKING SHEATHS IN SIZE TO FACILITATE THEIR APPLICATION DURING THE STENT/BALLOON BAKING PROCESS.
P970035|S028|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/11/2001|04/29/2002|||APPR|APPROVAL FOR THE THUNDER HIGH SCAFFOLDING OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RX) SAPHENOUS VEIN GRAFT (SVG) STENT SYSTEMS; THE ADDITION OF A NEW MANUFACTURING FACILITY, AVE IRELAND LIMITED, GALWAY, IRELAND; AND THE ADDITION OF A NEW CONTRACT STERILIZER, IOTRON EBIS INDUSTRIES UK, LTD., OXFORDSHIRE, UNITED KINGDOM.  THE DEVICES, WILL BE MARKETED UNDER THE TRADE NAMES OF THE THUNDER HIGH SCAFFOLDING OTW AND RX SVG STENT SYSTEMS, AND ARE INDICATED FOR IMPROVING VESSEL LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS (LENGTH <= 40 MM) IN SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS BETWEEN 3.0 MM AND 5.0 MM.  LONG TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  THE RX DELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2 CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY.  THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND ALONE PTCA PERFUSION CATHETER.
P990075|S003|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618|||HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000||SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/2001|06/18/2001|||APPR|APPROVAL FOR THE HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000.
P960016|S007|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4MM TIP|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/2001|10/04/2001|||APPR|APPROVAL FOR A CATHETER WITH A SYMMETRICALLY BIDIRECTIONAL DEFLECTABLE TIP.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIVEWIRE TC(TM) CARDIAC ABLATION SYSTEM: BIDIRECTIONAL 4 MM TIP AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR CARDIAC MAPPING, AND WHEN USED WITH A COMPATIBLE RADIOFREQUENCY GENERATOR FOR:  1) INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA;  2) THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA; AND  3) CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P990017|S020|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE(R) ENDOGRAFT(R) SYSTEM|MIH|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2001|08/17/2001|||APPR|APPROVAL FOR CHANGES TO MANUFACTURING PROCESS (ADDITION OF NEW IN-PROCESS QUALITY CHECKS, QUANTIFICATION OF INSPECTION CRITERIA, REMOVAL OF REDUNDANT WIRE INSPECTION, DEFINITION OF TESTING REQUIREMENTS FOR NEW LOTS OF ELGILOY WIRE, DIMENSIONAL CHANGES, AND ADDITION OF REQUIREMENTS FOR CONDUCTING CORROSION FATIGUE TESTING).
P990017|S021|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/2001|08/17/2001|||APPR|APPROVAL FOR CHANGES TO DESIGN AND MANUFACTURING TO ADDRESS INFERIOR RELEASE WIRE GETTING STUCK OR BREAKING IN THE ANCURE TUBE DEVICES DURING WIRE RETRACTION.
P830055|S078|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2001|06/13/2001|||APPR|APPROVAL FOR THE ADDITION OF REVISION TIBIAL BEARINGS, POROUS-COATED REVISION FEMORAL COMPONENTS, AND FEMORAL AND TIBIAL SLEEVE COMPONENTS.  ALSO, APPROVAL FOR MODIFICATIONS TO THE CURRENT TEXTURED REVISION FEMORAL COMPONENTS AND CURRENT REVISION FEMORAL AND TIBIAL AUGMENT COMPONENTS.  THE DEVICES, AS MODIFIED, WILL BE MARKETED AS LCS COMPLETE COMPONENTS.
P980001|S033|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR(R) PREMOUNTED STENT SYSTEM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2001|06/07/2001|||OK30|CHANGE IN THE ACCEPTANCE CRITERIA FOR AN IN-PROCESS INSPECTION STEP FOR THE BALLOON COMPONENT USED IN THE MANUFACTURE OF THE NIR(R) PREMOUNTED STENT SYSTEMS.
P800022|S050|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN|LMH|SU|Panel Track|Change Design/Components/Specifications/Material|N|05/16/2001|03/11/2003|03M-0114|03/28/2003|APPR|APPROVAL FOR COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN.  THE INDICATIONS FOR USE ARE AS FOLLOWS: COSMODERM 1 HUMAN-BASED COLLAGEN AND COSMODERM 2 HUMAN-BASED COLLAGEN ARE INJECTED INTO THE SUPERFICIAL PAPILLARY DERMIS FOR CORRECTION OF SOFT TISSUE CONTOUR DEFICIENCIES, SUCH AS WRINKLES AND ACNE SCARS, AND COSMOPLAST HUMAN-BASED COLLAGEN IS INJECTED INTO THE MID TO DEEP DERMIS FOR CORRECTION OF SOFT TISSUE CONTOUR DEFICIENCIES, SUCH AS WRINKLES AND ACNE SCARS.
P980049|S005|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ORCHESTRA PROGRAMMER|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2001|06/08/2001|||APPR|APPROVAL FOR PROGRAMMER APPLICATION SOFTWARE ELAVIEW (VERSION 1.04UG1).
P000006|S001|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|ALPHA I INFLATABLE PENILE PROSTHESIS|FHW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2001|06/14/2002|||APPR|APPROVAL FOR HYDROPHILIC COATING OF THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR ALPHA 1 INFLATABLE PENILE PROSTHESIS WITH HYDROPHILIC COATING AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.
P810046|S209|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|PERCUTANEOUS CORONARY DILATATION CATHETERS|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/17/2001|08/22/2001|||APPR|APPROVAL FOR MODIFICATIONS IN THE INSTRUCTIONS FOR USE BOOKLETS OF THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), ACS OTW PHOTON(TM), ACS RX GEMINI(TM), AND ACS RX ESPRIT PTCA CATHETERS.
P960025|S007|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE SYSTEM|MCV|OR|Normal 180 Day Track|Express GMP Supplement|N|05/17/2001|09/17/2001|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT DEPUY ACROMED, RAYNHAM, MASSACHUSETTS.
P970008|S017|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TARGIS SYSTEM|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/24/2001|06/05/2001|||APPR|APPROVAL TO REVISE THE LABELING TO 1) ADD PRIOR PELVIC RADIATION AS A CONTRINDICATION; AND 2) UPDATE THE LIST OF POTENTIAL ADVERSE EVENTS TO INCLUDE THE RISK OF RECTAL FISTULA.
P870025|S006|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR|MCP|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2001|11/09/2001|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT WIPRO GE MEDICAL SYSTEMS, BANGALORE, INDIA.
P000016|S001|GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES|8880 GORMAN ROAD||LAUREL|MD|20723||OXIMETER, FETAL PULSE|COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY|MMA|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2001|11/09/2001|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT WIPRO GE MEDICAL SYSTEMS, BANGALORE, INDIA.
P990017|S022|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2001|08/17/2001|||APPR|APPROVAL FOR LABELING AND MANUFACTURING CHANGES.
P990017|S023|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/2001|08/17/2001|||APPR|APPROVAL FOR MODIFICATIONS RELATED TO FORCE REQUIRED TO RETRACT DELIVERY CATHETER JACKET.
P850089|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE SP NOVUS LEAD MODEL 5594|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2001|06/14/2001|||APPR|APPROVAL FOR CAPSURE SP NOVUS LEAD MODEL 5594.  THE DEVICE IS INDICATED FOR PACING AN DSENSING IN THE ATRIUM.  THE LEAD HAS APPLICATIONS WHERE IMPLANTABLE ATRIAL SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED.
P990037|S006|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369|||VASCULAR SOLUTIONS DUETT SEALING DEVICE||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/21/2001|06/14/2001|||APPR|APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT ADD AND STRENGTHEN THE PRECAUTIONS AND INSTRUCTIONS.
P990017|S024|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE(R) ENDOGRAFT(R) SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2001|06/07/2001|||OK30|CHANGES TO IMPROVE THE DEBURRING PROCESS FOR THE TWO SLOT AREAS OF THE SMALL HYPOTUBE.
P970003|S034|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2001|06/29/2001|||APPR|APPROVAL FOR THE MODEL 101 IN-LINE PULSE GENERATOR (VERSION 2.0), MODEL 302 IN-LINE BIPOLAR LEADS (VERSION 1.0), MODEL 402 IN-LINE TUNNELING TOOL (VERSION 1.0 AND LABELING CHANGES.
P910054|S002|Toray Industries (America), Inc.|461 FIFTH AVENUE, 9TH FLOOR||NEW YORK|NY|10017||CATHETER, PERCUTANEOUS (VALVULOPLASTY)|INOUE BALLOON CATHETER|MAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/2001|02/13/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE INOUE BALLOON CATHETER WHICH IS INDICATED FOR PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY IN PATIENTS WITH HEMODYNAMICALLY SIGNIFICANT MITRAL VALVULAR STENOSIS RESULTING PRIMARILY FROM COMMISSURAL FUSION OF THE MITRAL VALVE CUSPS.
P990017|S025|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2001|08/17/2001|||APPR|APPROVAL FOR MODIFICATIONS RELATED TO THE CONTRALATERAL TORQUE CATHETER.
P990017|S026|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/22/2001|08/17/2001|||APPR|APPROVAL FOR MODIFICATIONS (20 MANUFACTURING PROCESS CHANGES AND ONE DESIGN CHANGE) RELATED TO THE DELIVERY CATHETER.
P980023|S004|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|DTA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/2001|07/12/2001|||APPR|APPROVAL FOR A NEW ICD SYSTEM THAT INCLUDES THE FOLLOWING: BELOS VR ICD (MODEL 330 444), BELOS TEST HOUSING (MODEL 331 116), AND BELOS VR PHYLAX XM/MYCROPHYLAX/PHYLAX 06/TMS 1000 APPLICATION SOFTWARE 1-K01.0.A (MODEL 338 045).  THE DEVICE, AS MODIFIED IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P960040|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2001|06/13/2001|||APPR|APPROVAL FOR MODEL 2725 VENTAK(R) PRIZM(TM) DIAGNOSTIC/RESTORATION TOOL VERSION 1.5.  THE DEVICE IS INDICATED TO DIAGNOSE AND RESTORE TO FACTORY NORMAL SETTINGS VENTAK PRIZM/PRIZM HE DEVICES THAT HAVE BEEN AFFECTED BY A SPECIFIC MEMORY INTERATION THAT RESULTS IN SAFETY MODE.
P960009|S017|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/2001|06/22/2001|||APPR|APPROVAL FOR A CHANGE TO THE LABELING TO ADD A CONTRAINDICATION REGARDING THE USE OF DIATHERMY ON PATIENTS IMPLANTED WITH A MEDTRONIC ACTIVA(R) TREMOR CONTROL SYSTEM.
P840001|S054|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|INTREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/2001|06/22/2001|||APPR|APPROVAL FOR A CHANGE TO THE LABELING TO ADD A CONTRAINDICATION REGARDING THE USE OF DIATHERMY ON PATIENTS IMPLANTED WITH A MEDTRONIC SPINAL CORD STIMULATION SYSTEM.
P980009|S007|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2001|08/16/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL) GALWAY, IRELAND.
N17600|S018|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2001|06/18/2001|||OK30|ELIMINATION OF CERTAIN IN PROCESS OR FINAL DEVICE TESTS PERFORMED ON AVITENE(R) COLLAGEN HEMOSTASIS (MCH) PRODUCTS.  THIS WILL ELIMINATE TEST REDUNDANCY, WASTE AND/OR PROVIDE A MORE EFFICIENT UTILIZATION OF TEST SAMPLES SELECTED DURING THE PROCESSING OF AVITENE.
P800002|S012|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2001|06/18/2001|||OK30|ELIMINATION OF CERTAIN IN PROCESS OR FINAL DEVICE TESTS PERFORMED ON AVITENE COLLAGEN HEMOSTASIS (MCH) PRODUCTS.  THIS WILL ELIMINATE TEST REDUNDANCY, WASTE AND/OR PROVIDE A MORE EFFICIENT UTILIZATION OF TEST SAMPLES SELECTED DURING THE PROCESSING OF AVITENE.
P950005|S013|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS II BIDIRECTIONAL DEFLECTING DIAGNOSTIC/ABLATION CATHETER|DRF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2001|06/22/2001|||APPR|APPROVAL FOR THE BIDIRECTIONAL CATHETER TIP TO BE MODIFIED FROM A DUAL LUMEN TO A QUAD LUMEN.
P970029|S007|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|ECLIPSE TMR HOLMIUM LASER SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/2001|11/01/2001|||APPR|APPROVAL FOR REVISIONS TO THE SOLOGRIP III INSTRUCTIONS FOR USE.
P970004|S015|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM(R) THERAPY FOR URINARY CONTROL|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/2001|06/26/2001|||APPR|APPROVAL FOR A CHANGE TO THE LABELING TO ADD A CONTRAINDICATION REGARDING THE USE OF DIATHERMY ON PATIENTS IMPLANTED WITH A MEDTRONIC INTERSTIM(R) SYSTEM.
P000044|S002|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2001|06/18/2001|||OK30|CHANGE TO THE ACCEPTANCE CRITERIA APPLIED TO THE TEST FOR HUMAN PLASMA USED AS A RAW MATERIAL IN THE FORMULATION OF ASSAY REAGENT, A COMPONENT OF THE VITROS HBSAG REAGENT PACK AND IN THE FORMULATION OF SAMPLE DILUENT, A COMPONENT OF THE VITROS HBASAG CONFIRMATORY KIT.
P900056|S064|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM CONSOLE AND DYNAGLIDE(TM)FOOT PEDAL|MCX|CV|Normal 180 Day Track|Express GMP Supplement|N|05/30/2001|09/07/2001|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITIES LOCATED AT PLEXUS CORPORATION, BOTHELL, WASHINGTON FOR THE MANUFACTURE OF THE ROTABLATOR(R) CONSOLE AND DYNAGLIDE(TM) FOOT PEDAL AND BOSTON SCIENTIFIC SCIMED IVUS TECHNOLOGY CENTER, FREMONT, CALIFORNIA FO RINSPECTION FUNCTIONS.
P990040|S001|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL(R) N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|Normal 180 Day Track|Other Report|N|03/01/2001|05/30/2001|||APPR|APPROVAL FOR REMOVAL OF THE POST ETHYLENE OXIDE STERILIZATION PYROGEN TEST OF THE N-BCA, REMOVAL OF THE POST-STERILIZATION FUNCTIONAL TESTING OF THE TANTALUM POWDER, THE ADDITION OF A PYROGEN TEST OF THE TANTALUM POWDER, AND THE VALIDATION OF THE PYROGENICITY TEST.
P950005|S014|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND TEMPERATURE CABLES|DRF|CV|Normal 180 Day Track|Express GMP Supplement|N|05/29/2001|06/27/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.
P920015|S022|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/31/2001|06/15/2001|||APPR|APPROVAL FOR MODEL 6726 DF-1 Y-ADAPTOR/EXTENDER KIT.  THE DEVICE IS INDICATED TO ADAPT TWO DF-1 LEAD CONNECTORS TO A SINGLE DF-1 COMPATIBLE CONNECTOR PORT AND/OR WILL EXTEND THE LENGTH OF A DF-1 LEAD CONNECTOR.  THE MODEL 6726 HAS APPLICATION FOR PATIENTS IN WHICH IDC SYSTEMS ARE INDICATED.
P980006|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES|LPM|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/2001|11/20/2001|01M-0531|11/29/2001|APPR|APPROVAL FOR THE PURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS.  THE DEVICE IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS OR LESS, THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +8.00D TO -20.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO -20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS.
P970031|S011|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/01/2001|11/16/2001|||APPR|APPROVAL FOR THE FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODEL 995, SIZE 29 MM; IMPLANTATION TECHNIQUES, SUBCORONARY, FULL-ROOT, AND ROOT INCLUSION.  THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHESTIC AORTIC VALVES WITH THE OPTION OF AORTIC ROOT REPLACEMENT.
P850079|S038|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/01/2001|07/25/2001|||APPR|APPROVAL FOR THE FREQUENCY MULTIFOCAL (METHAFILCONA) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED).  THE LENSES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THEY ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES WITH MYOPIA OR HYPEROPIA AND ARE PRESBYOPIC.  THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.
P930016|S014|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/04/2001|11/06/2001|01M-0522|11/21/2001|APPR|APPROVAL FOR THE VISX STAR S2 AND S3 EXCIMER LASER SYSTEMS.  THE DEVICES ARE INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS:  1) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND  2) IN PATIENTS 21 YEARS OF AGE OF OLDER IN TREATMENTS FOR THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM WHERE THE MAGNITUDE OF CYLINDER (<=6.0 D AT THE SPECTACLE PLANE) IS GREATER THAN THE MAGNITUDE OF SPHERE AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS.
P880027|S059|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BONNIE & BYPASS SPEEDY PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2001|06/21/2001|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE MANIFOLD COMPONENT OF THE BONNIE AND BYPASS SPEEDY PTCA CATHETERS.
P990053|S002|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST(TM) FETAL SENSOR FS14-SERIES|MMA|OB|Normal 180 Day Track|Express GMP Supplement|N|06/05/2001|12/19/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT TYCO HEALTHCARE GROUP, TIJUANA, MEXICO.
P980022|S007|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/2001|02/20/2002|||APPR|APPROVAL FOR A NEW VERSION OF SOFTWARE.
P960040|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS|LWP|CV|Normal 180 Day Track|Express GMP Supplement|N|06/06/2001|06/27/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING AND STERILIZATION FACILITY LOCATED AT GUIDANT IRELAND, CLONMEL TIPPERARY, IRELAND AND ALTERNATE STERILIZATION FACILITIES LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND AND GUIDANT, ST. PAUL, MINNESOTA.
P890055|S013|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/06/2001|10/18/2002|||APPR|APPROVAL FOR THE INDICATIONS FOR USE TO INCLUDE GLYCERIN INJECTION AS AN INFUSATE FOR USE WITH PATIENTS WHO ARE RECEIVING CONTINUOUS HEPATIC ARTERIAL FUDR CHEMOTHERAPY WITH THE ARROW INTERNATIONAL MODEL 3000 SERIES OF IMPLANTABLE INFUSION PUMPS TO KEEP THE CATHETER PATENT OR TO EXTEND THE REFILL INTERVAL FOR PATIENTS WHO REQUIRE THERAPY OR WITHDRAWAL.
P870072|S015|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/07/2001|11/30/2001|||APPR|APPROVAL FOR THE ISSUANCE OF TECHNICAL BULLETIN #009.
P890043|S037|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM|MCX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/07/2001|12/05/2001|||APPR|APPROVAL FOR LABELING CHANGES FOR THE FLEXI-CUT(TM) DIRECTIONAL DEBULKING SYSTEM.  THE LABELING CHANGES INCLUDE THE ADDITION OF A SUMMARY OF THE PHYSICIAN PREFERENCE TESTING INFORMATION, AND THE ADDITION OF A WARNING STATEMENT TO REMOVE ATHEROMATOUS TISSUE FROM THE NOSECONE FREQUENTLY TO AVOID GUIDEWIRE RESTRICTION.
P850010|S016|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/2001|06/29/2001|||APPR|APPROVAL FOR THE REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE INDICATIONS STATEMENT.
P810006|S020|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/2001|07/05/2001|||APPR|APPROVAL FOR THE REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE INDICATIONS STATEMENT.
P990066|S004|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/2001|12/06/2001|||APPR|APPROVAL FOR CHANGES TO THE IMAGE CHAIN SOFTWARE, SPECIFICALLY THE AUTOMATIC OPERATING PARAMETERS (AOP) AND THE AUTO-CONTRAST AND THICKNESS COMPENSATION ALGORITHMS; THE ADDITION OF SOME NEW FEATURES TO THE ACQUISITION WORK STATION AND THE REVIEW WORK STATION THAT PROVIDE MORE OPTIONS FOR IMAGE DISPLAY AND PRINTING; AND REVISED LABELING TO ADDRESS THE CHANGES.
P950037|S020|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/2001|10/10/2001|||APPR|APPROVAL FOR PULSE GENERATOR AND PROGRAMMER SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INOS2+ AND IS INDICATED FOR THE FOLLOWING APPLICATIONS:  1) RATE ADAPTIVE PACING WITH THE INOS PACING SYSTEM IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.  2) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME.  3)  PATIENTS WHOM DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
P990074|S007|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2001|07/03/2001|||OK30|ADDITION OF A SUPPLIER OF PROCESSED SILICONE SHEETING MATERIALS AND SILICONE COMPONENTS USED IN THE FABRICATION OF SALINE-FILLED BREAST IMPLANTS.
P850022|S013|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR|LOF|OR|Normal 180 Day Track|Express GMP Supplement|N|06/11/2001|10/10/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT ELECTRO-BIOLOGY, INC., GUAYNABO, PUERTO RICO.
P900056|S065|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS|MCX|CV|Normal 180 Day Track|Express GMP Supplement|N|06/12/2001|07/16/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC, LTD., CORK, IRELAND.
P000018|S014|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH(TM) SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2001|07/13/2001|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P960009|S018|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/15/2001|07/12/2001|||APPR|APPROVAL FOR A CHANGE TO THE LABELING TO ADD A PRECAUTION REGARDING THE PROGRAMMING OF DIFFERENT NEUROSTIMULATOR MODELS.
P980050|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6943 SPRINT(R) LEAD|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/14/2001|07/11/2001|||APPR|APPROVAL TO WITHDRAW THE ATRIAL INDICATION FOR THE MODEL 6943 LEAD.
P000040|S001|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR(R) ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|06/18/2001|07/10/2001|||APPR|APPROVAL FOR MANUFACTURING CHANGES TO THE PHYSICAL STRUCTURE OF THE HYDRO THERMABLATOR(R) UNIT.
P980007|S001|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ABBOTT AXSYM FREE PSA|MTG|IM|Normal 180 Day Track|Express GMP Supplement|N|06/15/2001|04/15/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT HEALTH PRODUCTS, BARCELONETA, PUERTO RICO.
P910007|S006|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ABBOTT AXSYM/TOTAL PSA|LTJ|IM|Normal 180 Day Track|Express GMP Supplement|N|06/15/2001|03/03/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT HEALTH PRODUCTS, INC., BARCELONETA, PUERTO RICO.
P980009|S008|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT(R) ENDOPROSTHESIS WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2001|08/16/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND.
P860004|S046|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED IMPLANTABLE INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|06/18/2001|06/29/2001|||APPR|APPROVAL FOR THREE NEW PUMP CONNECTOR DESIGNS AND A CHANGE IN THE MODEL 8709 CATHETER KIT CONTENTS:  1) NEW MODEL 8575 400 PUMP CONNECTOR FOR THE MODEL 8709 INTRATHECAL CATHETER.  2) NEW MODEL 8577 900 PUMP CONNECTOR FOR THE MODEL 8709 INTRATHECAL CATHETER.  3) NEW MODEL 8576 900 PUMP CONNECTOR FOR USE WITH THE MODEL 8700A AND MODEL 8700V VASCULAR CATHETERS. 4) NEW MODEL 8709 CATHETER KITS WILL REPLACE THE CURRENT CATHETERS WITH THE 400 MODEL 8575 PUMP CONNECTOR FOR SYNCHROMED PUMPS WITH A CAP (CATHETER ACCESS PORT), OR A MODEL 8577 900 PUMP CONNECTOR FOR A SYNCHROMED PUMP WITHOUT A CAP.
P950032|S024|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF/GRAFTSKIN|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2001|07/16/2001|||OK30|CHANGE TO USE AN ADDITIONAL SHIPPING CONTAINER FOR THE APLIGRAF(TM) DEVICE THAT WOULD MAINTAIN PRODUCT INTEGRITY FOR A PERIOD OF 72 HOURS.  THE CHANGE WILL ALLOW FOR GREATER FLEXIBILITY WITH DOMESTIC SHIPMENTS BY ENSURING PRODUCT INTEGRITY FOR A LONGER PERIOD, AND REDUUCE WASTE.
P990009|S008|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FUSION MATRIX-DRY|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2001|07/20/2001|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT FUSION MEDICAL TECHNOLOGIES, INC., FREMONT, CALIFORNIA.
P900033|S006|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA/DERMAL REGENERATION TEMPLATE|MDD|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/19/2001|08/10/2001|||APPR|APPROVAL FOR AN UPDATE OF THE DEVICE LABELING TO INCORPORATE THE RESULTS OF THE POSTAPPROVAL STUDY.
P830055|S079|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2001|07/06/2001|||APPR|APPROVAL FOR A LINE EXTENSION TO THE LCS TOTAL KNEE SYSTEM.  THE LINE EXTENSION CONSISTS OF ADDING MEDIUM SIZED COMPONENT OPTIONS TO APPROVED LCS TOTAL KNEE SYSTEM COMPONENTS.
P990052|S004|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE SYSTEM|MPV|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2001|07/24/2001|||APPR|APPROVAL FOR MODIFICATION TO THE MOUNTING OF THE ELECTRONIC MODULE ASSEMBLY, THE MICROPHONE AND THE PROGRAMMING SOCKET; CHANGE IN THE PHYSICAL SHAPE OF THE MAGNET FROM A NOTCHED-SHAPE TO A FULL ROUND SHAPE; CHANGE IN THE MATERIAL OF THE TIP COVER OF THE AUDIO PROCESSOR (AP) TO ACRYLONITRILE-BUTADIENE-STYRENE COPOLYMER (ABS) AND ADDITION OF THREE DIFFERENT COLORS (LIGHT BROWN, BROWN AND GRAY) TO BETTER MATCH THE HAIR COLORS OF THE FINAL USERS; AND PICTORIAL AND TEXT CHANGES TO REFLECT THE NEW SHAPE AND COLOR OF THE AP IN REFERENCE MANUAL FOR AUDIOLOGISTS AND PATIENT USER MANUAL.
P960047|S003|HOWMEDICA OSTEONICS CORP.|59 ROUTE 17 SOUTH||ALLENDALE|NJ|07401|1677||HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT||OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/22/2001|07/25/2001|||APPR|APPROVAL FOR 1) A DESIGN CHANGE TO THE OUTER BEARING INSERT OF THE TRIDENT(R) CONSTRAINED ACETABULAR INSERT - LATERALIZING THE HEAD CENTER BY 4 MM;  2) THE ADDITION OF ALUMINA FEMORAL HEADS FOR USE WITH THE HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT AND THE TRIDENT(R) CONSTRAINED ACETABULAR INSERT.
P970051|S017|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/22/2001|08/01/2001|||APPR|APPROVAL FOR SOFTWARE VERSIION R126.
P000015|S001|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/22/2001|08/01/2001|||APPR|APPROVAL FOR SOFTWARE VERSION R126.
P980023|S005|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS|DTA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/25/2001|10/24/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE LEGALLY MARKETED KAINOX RV AND KAINOX SL LEAD SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEROX RV 65 (MODEL 332 232), TEROX RV 75 (MODEL 332 231),KAINOX SL 65/13 (MODEL 124 235),KAINOX SL 65/16 (MODEL 124 236), KAINOX SL 65/18 (MODEL 124 237), AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).
P970004|S016|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2001|09/07/2001|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC NEUROLOGICAL PUERTO RICO OPERATIONS (MNPRO), VILLALBA, PUERTO RICO.
P890025|S013|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD|MGU|TX|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2001|09/05/2002|||APPR|APPROVAL TO PLACE INTO EFFECT THE UPDATED QUALITY CONTROL TEST FOR EVALUATING SHEEP ANTISERUM.
P960007|S015|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE|MGR|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/2001|08/30/2001|||APPR|APPROVAL FOR AMENDED LABELING TO INCLUDE INFORMATION REGARDING THE RESULTS OF TESTING THE DONOR MOTHER'S SERA FOR VIRUSES AND OTHER INFECTIOUS AGENTS.
P990009|S009|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM)|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/26/2001|08/10/2001|||APPR|APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM, THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE INDICATIONS STATEMENT AND THE ADDITION OF THE NASAL/SINUS INSTRUCTIONS AND INORMATION TO THE LABELING OF THE "DRY" FORM OF THE FUSION MATRIX PRODUCT.
P980048|S002|SULZER SPINE-TECH|7375 BUSH LAKE RD.||MINNEAPOLIS|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM|MAX|OR|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/22/2001|06/19/2002|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BAC/C DEVICE.  THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE APRIL 20, 2001, APPROVAL ORDER FOR P980048.
P990035|S002|BEAM-MED LTD|8 HALAPID STR.||PETACH TIKVA||49170||Bone sonometer|SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER|MUA|RA|Normal 180 Day Track|Express GMP Supplement|N|06/26/2001|07/27/2001|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT SUNLIGHT MEDICAL LTD., TEL-AVIV, ISRAEL.
P800035|S010|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|IMPLANT, ENDOSSEOUS, ROOT-FORM|PERI-OSS|DZE|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/2001|10/04/2001|||APPR|APPROVAL FOR A NEW TRADE NAME.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, PERI-OSS AND IS INDICATED FOR REPAIR OF PERIODONTAL AND PERIAPICAL BONY DEFECTS.
P910023|S053|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/28/2001|07/18/2001|||APPR|APPROVAL FOR THE USE OF A NEW BATTERY MODEL (WGL 2150) FOR THE LEGALLY MARKETED ST. JUDE MEPRO MD (MODELS V-186F AND V-1 DR (MODEL V-230HV) AND P 5 VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-194 AND V-232).  IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL FOR THE USE OF AN ALTERNATE IS-1 RECEPTACLE PLUG, MODEL AC-IP-2, FOR TH 5 DEVICES.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE MD (MODELS V-186F AND V-1 DR (MODEL V-230HV) IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND ARE INDICATED FOR USE IN PATIENTS WITH A HISTORY OF HEMODYNAMICALLY COMPROMISING VENTRICULAR TACHYARRHYTHMIAS.  THESE PATIENTS MAY HAVE EXPERIENCED A CARDIAC ARREST NOT ASSOCIATED WITH ACUTE MYOCARDIAL INFARCTION OR HAVE VENTRICULAR TACHYARRHYTHMIAS.  IN ADDITION, THESE PULSE GENERATORS CAN BE USED IN PATIENTS WHOSE PRIMARY THERAPY FOR HEMODYNAMICALLY SIGNIFICANT, SUSTAINED VENTRICULAR TACHYCARDIA IS ANTI-TACHYCARDIA PACING; THE DEFIBRILLATION CAPABILITIES OF THESE DEVICES PROVIDE HIGH-ENERGY THERAPY IN THE EVENT THAT THE ARRHYTHMIA ACCELERATES.  THE PULSE GENERATORS CAN BE IMPLANTED IN EITHER THE PECTORAL REGION OR THE ABDOMINAL REGION, AT THE PHYSICIAN'S DISCRETION.  THE PHOTON 5 VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-194 AND V-232) ARE INTENDED TO PROVIDE VENTRICULAR ANTI-TACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING  VENTRICULAR ARRHYTHMIAS.
P870072|S016|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track||N|06/29/2001|01/30/2002|||APPR|APPROAL FOR A BEVELED-TIP ATRIAL CANNULA TO REPLACE THE ORIGINAL ATRIAL CANNULA DESIGN.
P990036|S002|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014||Intravascular radiation delivery system|CORDIS CHECKMATE(TM) SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2001|07/27/2001|||OK30|CHANGE TO THE MANUFACTURING PROCESSING AND COLORANT OF THE UNI-DUMMY RIBBON ASSEMBLY TO THE CHECKMATE SYSTEM.
N18033|S036|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ETAFILCON HYDROPHILIC CONTACT LENSES|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2001|07/30/2001|||APPR|APPROVAL FOR AN ALTERNATE PACKAGE INTEGRITY TEST METHOD TO SUPPORT SHELF-LIFE AND ASSIGN EXPIRATION DATES IN LIEU OF STERILITY TESTING.
P960009|S019|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL THEREAPY SYSTEM|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/03/2001|12/31/2001|||APPR|APPROVAL FOR THE MODEL 7438 THERAPY CONTROLLER WHICH IS INTENDED TO BE USED AS AN ALTERNATIVE TO THE EXISTING MODEL 7452 CONTROL MAGNET AS A COMPONENT OF THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM.
P860004|S047|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/05/2001|08/01/2001|||APPR|APPROVAL FOR ADDITIONAL LABELING FOR PUMP REPLACEMENT PROCEDURES.
P900033|S007|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/2001|08/10/2001|||APPR|APPROVAL FOR MINOR CHANGES TO THE DEVICE LABELING.
P990013|S003|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STARR COLLAMER (TM) UV ABSORBING PC IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2001|07/20/2001|||OK30|CHANGE OF MANUFACTURING METHOD FOR STAAR COLLAMER(TM) INTRAOCULAR LENSES THAT INVOLVES THE ADDITION OF A SECONDARY CHROMOPHORE PURIFICATION PROCESS.
P950014|S021|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON (TM) SYSTEM DISPOSABLE TREATMENT APPLICATOR|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2001|09/19/2001|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT VENUSA DE MEXICO S.A. DE C.V, CHIHUAHUA, MEXICO, IN WHICH THE PROSTATRON DISPOSABLE TREATMENT APPLICATOR WILL BE ASSEMBLED.  IN ADDITION, APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT VENUSA LTD., EL PASO, TEXAS, FOR THE RECEIPT, INSPECTION, STORAGE, AND RELEASE OF COMPONENTS AND THE QUARANTINE OF FINISHED STERILIZED DEVICES.  ALSO, THE APPLICATOR WILL BE STERILIZED AT GRIFFITH MICROSCIENCE, SANTA TERESA, NEW MEXICO.
P830055|S080|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2001|10/03/2001|||APPR|APPROVAL FOR A MODIFICATION TO THE PACKAGING COMPONENTS OF THE LCS COMPLETE FEMORAL COMPONENTS AND ADDITION OF A PACKAGING SITE FOR THE METAL COMPONENTS OF THE LCS TOTAL KNEE SYSTEM AT DEPUY-RAYNHAM, RAYNHAM, MASSACHUSETTS.
P980050|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY)|LWS|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/27/2001|08/29/2001|||APPR|APPROVAL FOR THE POST-APPROVAL PROTOCOL FOR CONTINUED FOLLOW-UP OF THE PATIENTS WHO RECEIVED THE MODEL 7250 FOR THE AF ONLY INDICATION.
P840001|S055|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC MODEL 7424 ITREL(R) II, MODEL 7425 ITREL(R) III, AND MODEL 7427 SYNEEDRGY SPINAL CORD STIMULATION SYSTEMS|LGW|NE|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2001|08/14/2001|||APPR|APPROVAL FOR AN ADDITIONAL QUALITY CONTROL STEP TO VERIFY THAT THE NEUROSTIMULATORS ARE MANUFACTURED TO THERI SPECIFICATION, I.E. THAT THE NEUROSTIMULATOR HAS THE SPECIFIED INSULATION BETWEEN THE BATTERY AND THE INTERNAL SURFACE OF THE TITANIUM (CASE) SHIELD.
P960009|S020|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL THERAPY SYSTEM|MHY|NE|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2001|08/10/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ADDITIONAL QUALITY CONTOROL PROCESS STEP TO VERIFY THAT NEUROSTIMULATORS ARE MANUFACTURED TO THEIR SPECIFICATION, E.G., THE NEUROSTIMULATOR HAS THE SPECIFIED INSULATION BETWEEN THE BATTERY AND THE INTERNAL SURFACE OF THE TITANIUM CASE (SHIELD).
P990026|S004|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2001|08/03/2001|||OK30|CHANGE IN MANUFACTURING METHODS AND PROCEDURES TO UPGRADE FROM A MANUAL PROCESS AT CYGNUS, INC. TO AN EXPANDED AUTOMATED PROCESS AT CORIUM MANUFACTURING GROUP.
P990075|S004|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618|||SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY||SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/10/2001|09/05/2001|||APPR|APPROVAL FOR  1) AN INCREASE IN THE THICKNESS OF THE SHELL RADIUS/BASE FOR STYLE 5000PT AND  2) A DECREASE IN THICKNESS OF THE TEXTURED LAYER FROM 0.02" TO 0.01" FOR STYLES 5000, 5000PT, 6000 AND 6000PT.  THE SECOND CHANGE EFFECTIVELY WITHDRAWS THE APPROVED CHANGE IN SUPPLEMENT 2.
P960006|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 6616|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2001|02/04/2002|||APPR|APPROVAL FOR THE FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATION TOOL MODEL 6616.  THE FLEXTEND PACING LEADS MODELS 4086, 4087, AND 4088 ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
P990075|S005|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED MAMMARY PROSTHESES|FWM|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/2001|10/31/2001|||APPR|APPROVAL FOR REVISED PATIENT LABELING THAT INCORPORATES THE RESULTS OF THE FOCUS GROUP STUDY.
P940019|S008|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|ILIAC WALLSTENT SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|08/13/2001|||APPR|APPROVAL FOR A CHANGE TO A WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
P880065|S006|Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||PULSE-GENERATOR, PROGRAM MODULE|BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER|LOT|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|07/30/2001|||APPR|APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.
P000021|S001|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION PSA FLEX REAGENT CARTRIDGE|LTJ|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|07/31/2001|||APPR|APPROVAL FOR THE ADDITION OF THE DIMENSION(R) PSA FLEX(R) REAGENT CARTRIDGE FOR USE WITH THE DIMENSION(R) XPAND(TM) SYSTEM.
P900056|S066|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|08/13/2001|||APPR|APPROVAL FOR A CHANGE IN THE WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
P880027|S060|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|BOSTON SCINTIFIC SCIMED PTCA CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|07/30/2001|||APPR|APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.
P860019|S175|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA CATHETERS|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|08/14/2001|||APPR|APPROVAL FOR A LABELING CHANGE THAT STRENGTHENS A WARNING STATEMENT INCLUDED IN THE DIRECTIONS FOR USE MANUAL.  SPECIFICALLY, THE LABELING STATEMENT IS BEING MODIFIED TO EXPAND THE INFORMATION PROVIDED REGARDING THE AFFECT OF RE-PROCESSING OR RE-STERILIZATION.  THE CHANGE APPLIES TO ALL DIRECTIONS FOR USE MANUALS OF CURRENTLY MARKETED PTCA CATHETERS APPROVED UNDER THIS PMA.
P980009|S009|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|SCIMED MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|08/16/2001|||APPR|APPROVAL FOR A CHANGE IN THE WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
P980001|S035|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR CORONARY STENT WITH DELIVERY SYSTEM||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|08/16/2001|||APPR|APPROVAL FOR A CHANGE IN THE WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
P970061|S011|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311|||RADIUS CORONARY STENT WITH DELIVERY SYSTEM||CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|08/13/2001|||APPR|APPROVAL FOR A CHANGE IN THE WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
P930031|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|SCIMED TIPS WALLSTENT SYSTEM|MIR|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2001|08/13/2001|||APPR|APPROVAL FOR A CHANGE TO A WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
P940002|S005|SULZERMEDICA|9900 SPECTRUM DR.||AUSTIN,|TX|78717||PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|NATURAL-KNEE AND NATURAL-KNEE II|MBD|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2001|08/01/2001|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TO FURTHER ASSURE THE CLEANLINESS OF THE DEVICES.
P000007|S002|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/2001|03/26/2002|||APPR|APPROVAL FOR THE SIZE 29 MM PRIMA PLUS STENTLESS BIOPROSTHESIS.
P950018|S007|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2001|08/07/2001|||OK30|ELIMINATION OF FINISHED PRODUCT INTRAVITREAL TESTING FOR PERFLUORON  AND REVISION OF THE "PURIFIED PERFLUORO-N-OCTANE ANALYTICAL TEST MONOGRAPH" REGARDING CALCULATION OF IMPURITIES.  THE SPECIFICATION OF >=99.9% FOR PURIFIED PERFLUORO-N-OCTANE REMAINS UNCHANGED.
P970020|S034|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2001|08/14/2001|||OK30|CHANGE IN THE PYROGEN SAMPLING PLAN FOR THE MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS.
P980015|S004|INNOVATIVE MEDICAL SYSTEMS, INC.|3610 OAKDALE DRIVE||MOUNTAIN BROOK|AL|35223||Device, needle destruction|SHARPX NEEDLE DESTRUCTION UNIT|MTV|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/2001|08/15/2001|||APPR|APPROVAL FOR LABELING.
P980035|S011|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTS||CV|Normal 180 Day Track|Express GMP Supplement|N|07/16/2001|08/22/2001|||APPR|APPROVAL FOR ALTERNATE MANUFACTURING, PACKAGING AND STERILIZATION FACILITIES AT MEDTRONIC BV, THE NETHERLANDS AND MEDTRONIC EUROPE S.A., TOLOCHENAZ, SWITZERLAND.
P830061|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC PACING LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P850089|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC PACING LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P890003|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC PACING LEADS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P900061|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MICRO JEWEL/JEWEL II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P920015|S023|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P930039|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSUREFIX (R)|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P950024|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 4695|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P980016|S019|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||GEM DR/GEM II DR/GEM II VR||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P980050|S007|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7250 ARRHYTHMIA MANAGEMENT DEVICE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2001|08/08/2001|||OK30|CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
P950032|S025|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/19/2001|08/10/2001|||APPR|APPROVAL TO INTRODUCE A NEW CELL STRAIN INTO THE PRODUCTION OF APLIGRAF (I.E., HEP 700).
P990050|S002|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD,SUITE|11|SAN DIEGO|CA|92121||ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)|WAVSTAT OPTICAL BIOPSY SYTEM|MOA|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/2001|08/17/2001|||APPR|APPROVAL FOR A CHANGE IN THE TRADE NAME OF THE DEVICE AND RELATED ACCESSORIES TO ADD THE WORD "WAVSTAT(TM)" TO THE BEGINNING OF THE TRADE NAME.  THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO LOWER GASTROINTESTINAL (GI) ENDOSCOPY.  THE DEVICE IS INTENDED FOR THE EVALUATION OF POLYPS LESS THAN 1 CM IN DIAMETER THAT THE PHYSICIAN HAS NOT ALREADY ELECTED TO REMOVE.  THE DEVICE IS ONLY TO BE USED IN DECIDING WHETHER SUCH POLYPS SHOULD BE REMOVED (WHICH INCLUDES SUBMISSION FOR HISTOLOGICAL EXAMINATION).
P000020|S003|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|BARD STINGER ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/2001|08/20/2001|||APPR|APPROVAL FOR AN ADDITIONAL "G" CURVE CONFIGURATION AND ADDITIONAL LENGTH OF 85 CENTIMETERS FOR THE STINGER, STINGER M, AND STINGER S ABLATION CATHETERS.
P890023|S011|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/2001|01/16/2002|||APPR|APPROVAL FOR THE HYDROGENICS 60 (OCUFILCON F) UV IN-MONOMER TINT CONTACT LENS INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATIONS:  SPHERICAL: HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM UP TO 2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  TORIC: HYDROGENICS (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO -6.00 DIOPTERS.  THE OVERALL POWER RANGE IS +8.00D TO -10.00D SPHERE AND PL TO -6.00D CYLINDER.  THE LENS MAY BE PRESCRIBED FOR DAILY OR EXTENDED WEAR IN NOT-APHAKIC PERSONS.  WHEN PRESCRIBING FOR EXTENDED WEAR, THE EYE CARE PRACTITIONER MAY RECOMMEND LENS WEAR UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION.  THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENS FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULES REPLACEMENT.  WHEN PRESCRIBING FOR SCHEDULED REPLACEMENT WEAR, THE CONTACT LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) DISINFECTING SYSTEM.  HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
P980001|S036|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2001|08/21/2001|||OK30|CHANGE IN THE CLEANING PROCESS FOR THE STENT.
P970051|S018|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/2001|01/07/2002|||APPR|APPROVAL FOR THE MOST RECENT SOFTWARE VERSION FOR THE NEURAL RESPONSE TELEMETRY (NRTV3) TO BE USED WITH THE DEVICE.
P000015|S002|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/2001|01/07/2002|||APPR|APPROVAL FOR THE MOST RECENT SOFTWARE VERSION FOR THE NEURAL RESPONSE TELEMETRY (NRTV3) TO BE USED WITH THIS DEVICE.
P990074|S008|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2001|08/08/2001|||OK30|CHANGE IN MANUFACTURING METHOD.  THE CHANGE ADDS AN ALTERNATIVE METHOD FOR A CASTING PROCESS USING THE MOLDING METHOD OF THE STYLE 68 SALINE-FILLED BREAST IMPLANT SHELL COMPONENT USED IN THE FABRICATION OF SALINE-FILLED BREAST IMPLANTS.  THERE WILL BE NO CHANGES TO COMPONENT SPECIFICATIONS, DESIGNED PERFORMANCE SPECIFICATIONS OF THE FINISHED DEVICE, OR TO THE PMA DESIGNATED PHYSICAL AND CHEMICAL SPECIFICATIONS OF THE FINISHED DEVICE.
P900061|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) MODEL 5460 ACE HEADER|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/25/2001|09/05/2001|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) AND MODEL 5460 ACE HEADER.  THE DEVICE IS USED TO EMULATE AN IMPLANTABLE DEVICE DURING DEFIBRILLATION EFFICACY TESTING.
P850020|S013|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA COLUMN|LKN|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/2001|10/26/2001|||APPR|APPROVAL FOR REVISED LABELING THAT RELATES NEW POST-MARKET SAFETY INFORMATION REGARDING EPISODES OF VASCULITIS IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH THE PROSORBA(R) COLUMN.
P960043|S032|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|CLOSER / CLOSER S PERCUTANEOUS VASCULAR SURGERY DEVICES|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2001|08/15/2001|||APPR|APPROVAL FOR A MANUFACTURING AND SPECIFICATION CHANGE TO THE KNOT PUSHER WITH TRIMMER (SUTURE TRIMMER) HOOK ACCESSORY.
P990075|S006|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618|||MENTOR SALINE-FILLED BREAST IMPLANTS||SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2001|08/09/2001|||APPR|APPROVAL FOR LAL TESTING TO BE DONE ON A SKIP LOT AUDIT BASIS EVERY SIX MONTHS.
P960042|S007|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|16F LASER SHEATH ENHANCEMENT MODEL#500-013|MFA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/2001|01/25/2002|||APPR|APPROVAL FOR A MODIFICATION TO THE 16F LASER SHEATH KIT.
P990064|S006|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/2001|01/18/2002|||APPR|APPROVAL FOR THE MOSAIC PORCINE BIOPROSTHESIS, MODEL 305 AORTIC, 19MM.
P950037|S021|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/2001|09/10/2001|||APPR|APPROVAL FOR THE EXTERNAL DUAL-CHAMBER PACEMAKER MODELS EDP 30.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EDP 30 AND IS INDICATED FOR:  1) TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK;  2) PRE-, INTRA-, AND POSTOPERATIVE TEMPORARY STIMULATION OF PATIENTS UNDERGOING CARDIAC SURGERY;  3) PROPHYLACTIC PACING FOR PREVENTION OF ARRHYTHMIAS, AND  4) EMERGENCY PACING.
P990017|S027|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOVASCULAR SOLUTIONS ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2001|08/17/2001|||APPR|APPROVAL FOR THREE MONTH SHELFT LIFE BASED ON CHANGES TO PACKAGING.
P970007|S003|Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK|IL|60064||ENZYME IMMUNOASSAY, TRACROLIMUS|IMX TACROLIMUS II|MLM|TX|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2001|09/05/2002|||APPR|APPROVAL FOR CHANGES TO THE ABBOTT IMX TACROLIMUS II MASTER LOT TESTING.
P970007|S004|Abbott Laboratories|200 ABBOTT PARK RD.||ABBOTT PARK|IL|60064||ENZYME IMMUNOASSAY, TRACROLIMUS|IMX TACROLIMUS II|MLM|TX|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2001|09/05/2002|||APPR|APPROVAL FOR THE ADDITION OF TESTING OF MODEL 1 CALIBRATOR TO VERIFY THE PROPER FILLING OF THE CALIBRATOR.
P000018|S015|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH 3.5 FR SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/2001|02/08/2002|||APPR|APPROVAL FOR THE NOVOSTE BETA-CATH 3.5 FR SYSTEM.  THE NOVOSTE BETA-CATH 3.5 FR SYSTEM IS INDICATED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS (TREATABLE WITH A 20 MM BALLOON) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.
P990026|S005|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/2001|08/28/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER.
P870072|S017|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/2001|10/09/2002|||APPR|APPROVAL TO EXPAND THE INDICATIONS FOR USE FOR THE TLC-II PORTABLE VAD DRIVER SYSTEM TO INCLUDE THE TRANSPORTATION OF VAD PATIENTS VIA GROUND AMBULANCE.
P980001|S037|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR PREMOUNTED STENT DELIVERY SYSTEMS||CV|Normal 180 Day Track|Express GMP Supplement|N|08/01/2001|09/20/2001|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITIES FOR PACKAGING AND LABELING LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY MASSACHUSETTS AND BOSON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
P930029|S015|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONTACTR  ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/06/2001|10/09/2001|||APPR|APPROVAL FOR ADDITION OF A SECONDARY DISTAL CURVE FEATURE CAPABLE OF DEFLECTIONS OF UP TO 135 DEGREES AND THE REMOVAL OF THE VARIABLE CURVE REACH FEATURE AND OTHER MINOR DESIGN CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RF CONTACTR ABLATION CATHETER AND IS INDICATED FOR USE WITH A MEDTRONIC RF POWER GENERATOR FOR THE INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA FOR THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA AND FOR CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P970020|S035|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/06/2001|01/14/2002|||APPR|APPROVAL FOR THE ADDITION OF AN INDICATION TO USE THE 4.5 MM AND 5.0 MM ULTRA OTW AND RX FOR THE TREATMENT OF SAPHENOUS VEIN GRAFT (SVG) LESIONS.  THE MULTI-LINK RX ULTRA AND MULTI-LINK OTW ULTRA CORONARY STENT SYSTEM WILL INCLUDE THE FOLLOWING INDICATION:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL EIAMETERS RANGING FROM 3.5 MM TO 5.0 MM;  2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <=35) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.5 MM TO 5.0 MM; AND  3) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=35 MM IN LENGTH WITH REFERENCE DIAMETERS IN THE RANGE OF 3.5 MM TO 5.0 MM.  LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  NOTE: THE 38 MM LENTGH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE AND PATIENTS WITH LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS.
P980016|S020|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||MEDTRONIC GEM DR MODEL 7271||CV|Normal 180 Day Track|Express GMP Supplement|N|08/06/2001|09/05/2001|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING AND STERILIZATION FACILITY LOCATED AT MEDTRONIC EUROPE S.A., TOLOCHENAZ, SWITZERLAND AND AN ALTERNATE PACKAGING FACILITY LOCATED AT MEDTRONIC BV, KERKRADE, THE NETHERLANDS.
P860019|S176|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Express GMP Supplement|N|08/06/2001|09/07/2001|||APPR|APPROVAL FOR THE ALTERNATE FACILITIES FOR PACKAGING AND LABELING LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY, MASSACHUSETTS AND BONSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
P880027|S061|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|SCHNEIDER PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Express GMP Supplement|N|08/06/2001|09/07/2001|||APPR|APPROVAL FOR THE ALTERNATE FACILITIES FOR PACKAGING AND LABELING LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
P970020|S036|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX PENTA CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/2001|01/14/2002|||APPR|APPROVAL FOR THE ADDITION OF AN INDICATION TO USE THE 3.0 MM TO 4.0 MM PENTA(TM) OTW AND TX FOR THE TREATMENT OF SVG LESIONS.  THE MULTI-LINK RX PENTA AND MULTI-LINK OTW PENTA CORONARY STENT SYSTEM WILL INCLUDE THE FOLLOWING INDICATION:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENC EVESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM;  2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <=35 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM; AND  3) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=35 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 MM TO 4.0 MM.  LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  NOTE: THE 2.5 MM AND 2.75 MM STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE.  THE 33 MM AND 38 MM LENGTH STENTS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE AND PATIENTW WITH LESIONS IN SAPHENOUS BEIN BYPASS GRAFTS.
P000018|S016|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|Real-Time Process|Postapproval Study Protocol - ODE/OIR|N|08/07/2001|01/30/2002|||APPR|APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE 30 MM AND 40 MM BET SYSTEMS.  THE REVISED POST-APPROVAL STUDY IS INTENDED TO VERIFY THAT THE CORRECTIVE ACTIONS, INTENDED TO HELP MINIMIZE THE INCIDENCE OF DEVICE FAILURES AND MALFUNCTIONS SEEN DURING THE PREMARKET CLINICAL INVESTIGATIONS, ARE SUCCESSFUL IN REDUCING THE DEVICE FAILURE AND MALFUNCTION RATE.
P850020|S014|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA COLUMN|LKN|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2001|08/28/2001|||OK30|ELIMINATION OF THE SHAKING STEP FROM THE MANUFACTURING PROCESS.
P960011|S007|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)|LZP|OP|Normal 180 Day Track|Express GMP Supplement|N|08/08/2001|11/01/2002|||APPR|APPROVAL FOR A NEW STERILIZATION FACILITY LOCATED AT MEDIPLAST ISRAEL, LTD., YAVNEM, ISRAEL
P000032|S001|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION UTERINE CRYOBLATION THERAPY SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/09/2001|09/07/2001|||APPR|APPROVAL FOR REVISIONS TO THE HER OPTION(TM) UTERINE CRYOBLATION THERAPY(TM) SYSTEM LABELING.
P890057|S015|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|HIGH FREQUENCY OSCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/2001|01/08/2002|||APPR|APPROVAL OF A MODIFICATION TO THE DESIGN OF THE DRIVER DIAPHRAGM IN THE DEVICE.
P990035|S003|BEAM-MED LTD|8 HALAPID STR.||PETACH TIKVA||49170||Bone sonometer|SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER|MUA|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/2001|05/24/2002|||APPR|APPROVAL FOR CHANGING THE MANUFACTURING CALIBRATION SOFTWARE BY ADDING A NEW SPECIFICATION AND TEST METHODS THAT LIMITS THE AMPLITUDES OF THE THREE DIFFERENT PROBES WHICH ARE USED FOR THE APPROVED MULTIPLE SKELETAL SITES TO LESS THAN 520MV AND NORMALIZES THE PROBES TO PREDEFINED VALUES OF APPROXIMATELY 400MV.
P950022|S013|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|TVL LEAD SYSTEM|LWS|CV|Normal 180 Day Track|Express GMP Supplement|N|08/10/2001|09/26/2001|||APPR|APPROVAL FOR THE ALTERNATE MANUFACTURING FACILLITY LOCATED AT ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION, SYLMAR, CALIFORNIA.
P000009|S002|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TACHOS DR IMPLANTALBLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2001|09/04/2001|||APPR|APPROVAL FOR CHANGES TO THE EMBEDDED AND PROGRAMMER SOFTWARE FOR THE TACHOS DR.  THE NEW VERSION NUMBER FOR THE SOFTWARE CARTRIDGE FOR TACHOS DR/PHYLAX AV/TMS 1000 APPLICATIONS IS I-HDR.0.U/4 (MODEL 338 373).  THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P880086|S084|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2001|09/05/2001|||APPR|APPROVAL FOR THE MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE.
P830045|S077|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2001|09/05/2001|||APPR|APPROVAL FOR THE MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE.
P910023|S054|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2001|09/05/2001|||APPR|APPROVAL FOR THE MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE.
P990066|S005|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2001|09/12/2001|||OK30|MANUFACTURING PROCESS CHANGE, ADDING ADDITIONAL TEST TO ONE OF THE INCOMING INSPECTION TESTS FOR THE DETECTOR.  THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
P950035|S010|BIOCONTROL TECHNOLOGY, INC.|1945 EAST 97TH||CLEVELAND|OH|44106|4720|Stimulator, neuromuscular, implanted|NEUROCONTROL FREEHAND SYSTEM|GZC|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/14/2001|09/13/2001|||APPR|APPROVAL FOR REVISIONS TO THE LABELING THAT SPECIFY THE MAXIMUM DEPTH BELOW THE SURFACE OF THE SKIN AT WHICH THE IMPLANTABLE RECEIVER-STIMULATOR (IRS) SHOULD NOT EXCEED WHEN IMPLANTED AND CLARIFYING THE INSTRUCTIONS FOR CONNECTING THE EXTERNAL CONTROLLER TO THE CLINICAL PROGRAMMING STATION.
P970035|S029|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2001|10/04/2001|||APPR|APPROVAL FOR THE S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RX) CORONARY STENT SYSTEMS USING THE AV100 BALLOON MATERIAL.  (NOTE THAT ALTHOUGH THIS MATERIAL WAS INCLUDED IN PRODUCT USED IN THE CLINICAL TRIAL REPORTED IN SUPPLEMENT 22, APPROVAL WAS ONLY SOUGHT AND GRANTED FOR THE AV2000 BALLOON MATERIAL.)
P900061|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM VR MODELS 7227 B/D/E/CX|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/2001|10/10/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE CONNECTOR MODULES AND CONNECTOR ASSEMBLY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GEM VR MODELS 7227 B/D/E/CX AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS:  1) SURVIVAL OF AT LEAST ONE EPISODE OF A CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA  2) RECURRENT, POORLY TOLERATED, SUSTAINED VENTRICULAR TACHYCARDIA.
P990026|S006|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2001|09/04/2001|||OK30|CHANGE IN SUPPLIER OF GLUCOSE OXIDASE FOR THE AUTOSENSOR TO TOYOBO RESEARCH CENTER CO. LTD.
P950032|S026|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2001|09/14/2001|||OK30|MODIFICATION TO THE SHIPPER BOX TO NOW CONTAIN 12 POUNDS OF EUTECTIC BRICKS TO MAINTAIN TEMPERATURES ABOVE 20 DEGREES CELCIUS FOR THE 72 HOUR DURATION.
P920032|S008|PACE MEDICAL|391 TOTTEN POND RD.||WALTHAM|MA|02451||PULSE-GENERATOR, PACEMAKER, EXTERNAL|MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER|DTE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/2001|02/20/2002|||APPR|APPROVAL FOR THE MICRO-PACE MODEL 4580.  THE DEVICE IS INDICATED FOR "ANY CLINICAL SITUATION  IN WHICH THE USE OF TEMPORARY PACEMAKER ON A PATIENT PROVIDES THERAPEUTIC OR DIAGNOSTIC VALUE, OR SERVES A PROPHYLACTIC PURPOSE.  SPECIFICALLY, INDICATIONS FOR TEMPORARY PACEMAKERS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:  INTERMITTENT OR COMPLETE HEART BLOCK ASSOCIATED WITH ASYSTOLE OR BRADYCARDIA, SYMPTOMATIC SINUS BRADYCARDIA, SURGICALLY-INDUCED HEART BLOCK AND HEART BLOCK ACCOMPANYING AN ACUTE MYOCARDIAL INFARCTION.  ADDITIONALLY, TEMPORARY CARDIAC PACING HAS BEEN USED TO OVERDRIVE AND THEREBY TERMINATE ATRIAL ARRHYTHMIAS, INCLUDING ATRIAL FLUTTER.  IT HAS BEEN USED IN PREPARATION FOR PERMANENT PACEMAKER IMPLANTATION TO ASCERTAIN THE THRESHOLDS FOR SENSING AND PACING ON THE ACUTE LEAD SYSTEM."
P950034|S018|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK|MCN|SU|Real-Time Process|Other Report|N|08/20/2001|10/04/2001|||APPR|APPROVAL FOR AN ALTERNATE PRODUCT RELEASE FACILITY AT GENZYME SURGICAL PRODUCTS, FALL RIVER, MASSACHUSETTS.
P000022|S007|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|BESTENT (TM) 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|08/20/2001|09/26/2001|||APPR|APPROVAL FOR AMENDING THE TEST OF THE BESTENT 2 POST-APPROVAL STUDY PROTOCOL TO REFLECT ADMINISTRATIVE UPDATES.
P990078|S005|SUNRISE TECHNOLOGIES, INC.|3400 W. WARREN AVE.||FREMONT|CA|94538||Laser, ophthalmic|HYPERION LTK SYSTEM|HQF|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2001|05/08/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT A-PLUS/C-MAC, FREMONT, CALIFORNIA.
P950020|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/2001|01/23/2002|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE DEVICE:  1) MODIFICATION OF THE DESIGN AND MATERIALS OF CONSTRUCTION OF THE Y-SITE ASSEMBLY;  2) USE OF A COLORANT IN THE GUIDEWIRE LUMEN TUBING;  3) NEW PACKAGING CONFIGURATION AND MATERIALS; AND  4) USE OF AN ALTERNATIVE STERILIZER.
P990085|S001|Johnson & Johnson Vision Care, Inc.|7500 CENTURION PKWY.|SUITE 100|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|LENEFILCON A HYDROPHILIC CONTACT LENSES|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2001|09/19/2001|||APPR|APPROVAL FOR AN ALTERNATE PACKAGE INTEGRITY TEST METHOD TO SUPPORT SHELF-LIFE AND ASSIGN EXPIRATION DATES IN LIEU OF STERILITY TESTING.
P880086|S085|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|INTEGRITY AFX DR MODEL 5346|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2001|10/02/2001|||APPR|APPROVAL FOR THE MODEL 3307 V2.4.1A PROGRAMMER SOFTWARE WHICH ALLOWS FOR THE INTEGRITY AFX DR MODEL 5342 AND INTEGRITY U DR MODEL 5336 TO ACCESS THE DYNAMIC ATRIAL OVERDRIVE (DAO) AND ADVANCED HYSTERESIS FEATURES.
P830045|S078|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|INTEGRITY AFX DR MODEL 5346|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2001|10/02/2001|||APPR|APPROVAL FOR THE MODEL 3307 V2.4.1A PROGRAMMER SOFTWARE WHICH ALLOWS FOR THE INTEGRITY AFX DR MODEL 5342 AND INTEGRITY U DR MODEL 5336 TO ACCESS THE DYNAMIC ATRIAL OVERDRIVE (DAO) AND ADVANCED HYSTERESIS FEATURES.
P910023|S055|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|PROFILE MD (MODELS V-186F AND V-186HV3), PHOTON DR (MODEL V-230HV) AND PHOTON U VR/DR IMPLANTABLE CARDIOVERTER|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2001|10/02/2001|||APPR|APPROVAL FOR THE MODEL 3307 V2.4.1A PROGRAMMER SOFTWARE WHICH ALLOWS FOR THE INTEGRITY AFX DR MODEL 5342 AND INTEGRITY 5 DR MODEL 5336 TO ACCESS THE DYNAMIC ATRIAL OVERDRIVE (DAO) AND ADVANCED HYSTERESIS FEATURES.
P000020|S004|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER SM ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2001|10/10/2001|||APPR|APPROVAL FOR THE ADDITION OF ANOTHER ABLATION CATHETER MODEL TO THE EXISTING STINGER(TM) PRODUCT LINE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STINGER(TM) SM ABLATION CATHETER AND IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC STIMULI.
P970003|S035|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/27/2001|09/04/2001|||APPR|APPROVAL FOR A CHANGE TO THE LABELING TO ADD A CONTRAINDICATION REGARDING THE USE OF DIATHERMY ON PATIENTS IMPLANTED WITH THE NEUROCYBERNETIC PROSTHESIS (NCP(R)) SYSTEM.
P000018|S017|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE (TM) BETA-CATH(TM) SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2001|09/26/2001|||OK30|ALTERNATE METHOD OF MANUFACTURE FOR THE DRYING OPERATION OF THE BETA-CATH(TM) DELIVERY CATHETER.
P990026|S007|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|Normal 180 Day Track|Express GMP Supplement|N|08/28/2001|10/25/2001|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT CYGNUS, INC., REDWOOD, CALIFORNIA.
P000011|S003|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)|MAF|CV|Normal 180 Day Track||N|06/28/2001|12/21/2001|||APPR|APPROVAL FOR:  1) THE BIODIVYSIO(TM) SV OTW IN 10 MM, 15 MM AND 18 MM STENT LENGTHS AND 2.0 MM AND 2.5 MM DIAMETERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO(TM) SV OTW AND IS INDICATED FOR "IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS EXPERIENCING ABRUPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >=2.0 MM TO <=3.0 MM BY VISUAL ESTIMATE.  LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT."  2) THE BIODIVYSIO(TM) AS OTW IN 11 MM AND 15 MM STENT LENGTHS AND 3.0 MM, 3.5 MM AND 4.0 MM DIAMETERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO(TM) AS OTW AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: A)SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >=3.0 MM TO 4.0 MM;  B)SUBJECTS EXPERIENCING ABURPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH REFERENCE VESSEL DIAMETER RANGING FROM >=3.0 MM TO <=4.0 MM BY VISUAL ESTIMATION.  LONG TERM OUTCOME (BEYOND 6 MONTHS) FOR THESE PERMANENT IMPLANTS ARE UNKNOWN AT PRESENT.
P950034|S020|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM BIORESORBABLE MEMBRANE|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2001|09/28/2001|||OK30|CHANGE INVOLVING CONVERTING THE SEPRAFILM MANUFACTURING AREA FROM A DEDICATED AREA TO A SHARED AREA SHERE STERILE HYALURONIC ACID (HA) WILL BE PRODUCED.  THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES WITH THE PROPER CLEANING OF THE THREE VESSELS.  THE CLEANING PROCESS HAS BEEN VALIDATED.
P980001|S038|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760|||NIR STENT DELIVERY SYSTEMS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2001|09/26/2001|||OK30|ALTERNATIVE MANUFACTURING PROCESS TO PRODUCE BALLOONS FOR NIR(R) AND NIROYAL(R) STENT DELIVERY SYSTEMS.  THE ALTERNATIVE PROCESS AFFECTS ONLY THE METHOD OF STRETCHING THE BALLOON TUBING PRIOR TO MOLDING THE BALLOON.
P000018|S018|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE 60 MM BETA-CATH 5 FR SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/31/2001|03/25/2002|||APPR|APPROVAL FOR THE NOVOSTE BETA-CATH 60 MM 5 FR SYSTEM.  THE NOVOSTE BETA-CATH 60 MM 5 FR SYSTEM IS INTENDED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS WITH INJURY AREAS UP TO 40 MM IN A REFERENCE VESSLE DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.
P000011|S004|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|BIODIVYSIO OC/OTW STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/31/2001|03/01/2002|||APPR|APPROVAL FOR THE BIODIVYSIO OC OTW IN 11 MM, 15 MM, 18 MM, 22 MM AND 28 MM STENT LENGTHS AND 3.0 MM, 3.5 MM AND 4.0 MM DIAMETERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO OC OTW AND IS INDICATED FOR:  "USE IN SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >= 3.0 MM TO <= 4.0 MM AND INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER.  LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT."
P990074|S009|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|MCGHAN RTV SALINE-FILLED BREAST IMPLANTS - STYLES 68, 163, 168, 363 AND 468|FWM|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2001|09/21/2001|||APPR|APPROVAL TO ADD MECHANICAL TESTING OF SAMPLE SHELLS PRODUCED AS PART OF THE INCOMING INSPECTION PROCESS FOR THE RTV SILICONE DISPERSION.  THIS TESTING SERVES AS AN ADDITIONAL CRITERION FOR THE ACCEPTANCE OF THE RAW MATERIAL USED TO MAKE ALL STYLES OF THE SALINE-FILLED BREAST IMPLANTS.
P990009|S010|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/31/2001|02/06/2002|||APPR|APPROVAL FOR THE REMOVAL OF THE UROLOGICAL EXCLUSION FROM THE INTENDED USE STATEMENT.
P960025|S008|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE(R) SYSTEM|MCV|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2001|03/01/2002|||APPR|APPROVAL FOR A WEDGED VERSION OF THE I/F CAGE COMPONENT.  THE INDICATION FOR THESE IMPLANTS HAS NOT BEEN CHANGED FROM THAT APPROVED ON FEBRUARY 2, 1999.
P990066|S006|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2001|10/01/2001|||OK30|ADDITION OF A SUPPLIER FOR THE COLUMN MOUNTED ON THE SENOGRAPHE 2000D SYSTEM.  THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES (ASSEMBLY AND TESTING).  THERE ARE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
P990080|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A||OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2001|10/16/2001|||APPR|APPROVAL FOR A NEW FOLDABLE, ULTRAVIOLET LIGHT-ABSORBING, POSTERIOR CHAMBER INTRAOCULAR LENS MODEL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL Z9000 AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION.  THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P930038|S032|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|8F ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2001|10/02/2001|||OK30|ST. JUDE TO MANUFACTURE THE 8F ARTERIAL ANCHORS IN-HOUSE.
P000037|S001|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Panel Track|Change Design/Components/Specifications/Material|N|09/07/2001|03/06/2002|02M-0255|06/05/2002|APPR|APPROVAL FOR THE ON-X PROSTHETIC HEART VALVE, MODEL ONXM IN SIZES 25 MM, 27/29 MM, 31/33 MM, AND MODEL ONXMC IN SIZE 25/33 MM IN THE MITRAL POSITION.  THIS DEVICE IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE MITRAL POSITION.
P990042|S001|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS ASSAY|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/2001|02/04/2002|||APPR|APPROVAL FOR THE MODIFICATION TO THE ASSAY CUTOFF FROM 15 MIU/ML TO 10 MIU/ML.
P970035|S030|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7/S670/S660/BESTENT WITH DISCRETE TECHNOLOGY (TM) RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2001|10/02/2001|||OK30|CHANGES IN THE MANUFACTURING PROCESS OF JOINING THE TWO TYPES OF TUBING TO A PROCESS WHERE THE JACKET IS EXTRUDED DIRECTLY ONTO THE HYPOTUBE.
P000022|S008|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, CORONARY|S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2001|10/02/2001|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF JOINING THE TWO TYPES OF TUBING TO A PROCESS WHERE THE JACKET IS EXTRUDED DIRECTLY ONTO THE HYPOTUBE.
P810002|S057|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL REGENT MECHANICAL HEART VALVE (AORTIC)|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/07/2001|03/04/2002|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE SJM STANDARD VALVE, SIZES 19, 21, 23, 25 AND 27 MM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REGENT MECHANICAL HEART VALVE AND IS INDICATED AS A REPLACEMENT VALVE IN PATIENTS WITH A DISEASED, DAMAGED, OR MALFUNCTIONING AORTIC VALVE.  THIS DEVICE MAY ALSO BE USED TO REPLACE A PREVIOUSLY IMPLANTED PROSTHETIC HEART VALVE.
P900052|S009|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH EPIDURAL SYSTEMS|LNY|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2001|10/01/2001|||OK30|ELIMINATE THE INSPECTION PROCEDURE ON SOME INCOMING COMPONENTS USED IN THE MANUFACTURE OF THE PORT-A-CATH(R) EPIDURAL SYSTEMS.
P960043|S033|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|THE CLOSER AND CLOSER S SUTURE MEDIATED CLOSURE DEVICES|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2001|11/28/2001|||APPR|APPROVAL FOR A CHANGE IN THE INSPECTION METHOD FOR THE CUFF TABS.
N50510|S146|BIOMERIEUX VITEK, INC.|595 ANGLUM DR.||HAZELWOOD|MO|63042|2395|SUSCEPTIBILITY TEST CARDS, ANTIMICROBIAL|VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL|LTW|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/2001|10/17/2001|||APPR|APPROVAL FOR A LABELING CHANGE TO ADD AN INSTRUCTION TO THE VITEK 2 USER'S MANUAL WHICH DESCRIBES ADDITIONAL VISUAL OBSERVATION STEPS TO THE PROCEDURE FOR THE INSTALLATION OF THE VITEK 2 ACCESSORY KIT AND SALINE BAG.
P910023|S056|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/17/2001|10/15/2001|||APPR|APPROVAL FOR MINOR UPDATES TO THE DEVICE SOFTWARE FOR THE PHOTON DR ICD (MODEL V-230HV) AND THE PHOTON MICRO (U) VR/DR ICDS (MODELS V-194/V-232) AND MINOR UPDATED TO THE PROGRAMMER SOFTWARE SUPPORTING THE MODEL 3500 AND MODEL 3510 PROGRAMMERS AS WELL AS THE SOFTWARE SUPPORTING THE PR-1500 AND PR-3500 MODEL PROGRAMMERS.
P950020|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON MONORAIL|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/17/2001|02/15/2002|||APPR|APPROVAL FOR A RAPID EXCHANGE VERSION OF THE CUTTING BALLOON.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL AND IS INDICATED FOR DILATATION OF STENOSIS IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.  IN ADDITION, THE TARGET LESION SHOULD POSSES THE FOLLOWING CHARACTERISTICS: DISCRETE (<=15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH); WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.0 MM TO 4.0 MM; READILY ACCESSIBLE TO THE DEVICE; LIGHT TO MODERATE TORTUOSITY OF PROXIMAL VESSEL SEGMENT, NON-ANGULATED LESION SEGMENT (<45 DEGREES), SMOOTH ANTIOGRAPHIC CONTOUR; AND ABSENCE OF ANGIOGRAPHICALLY-VISIBLE THROMBUS AND/OR CALCIFICATION.
P990050|S003|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD,SUITE|11|SAN DIEGO|CA|92121||ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)|WAVSTAT (TM) OPTICAL BIOPSY SYSTEM|MOA|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/17/2001|11/28/2001|||APPR|APPROVAL FOR A NEW CONSOLE TO BE USED WITH THE OBS.  THIS NEW CONSOLE CONSISTS OF A RECONFIGURATINO OF THE ORIGINAL CONSOLE AND INCORPORATES SEVERAL FEATURES INTENDED TO IMPROVE USABILITY OF THE DEVICE.
P960009|S021|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2001|10/19/2001|||APPR|APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO ADD QUALITY CONTROL PROCESS STEPS TO VERIFY THAT THE DEEP BRAIN STIMULATION LEADS, MODELS 3387 AND 3389, ARE MANUFACTURED TO THEIR SPECIFICATION.
P990026|S008|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|09/19/2001|08/26/2002|02M-0412|09/16/2002|APPR|APPROVAL FOR THE GLUCOWATCH G2 BIOGRAPHER, WHICH EXPANDS THE INDICATIONS FOR USE TO INCLUDE CHILDREN/ADOLESCENTS (AGE 7 TO 17) TO THE CURRENTLY APPROVED INDICATIONS FOR USE.  THIS DEVICE IS NOW INDICATED FOR THE FOLLOWING:  1) THE GLUCO WATCH G2 BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) AND CHILDREN/ADOLESCENTS (AGE 7 TO 17) WITH DIABETES.  THIS DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES.  THE DEVICE IS FOR PRESCRIPTION USE ONLY.  2) THE GLUCOWATCH G2 BIOGRAPHER IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.  3)  THE BIOGRAPHER IS INDICATED FOR USE IN THE DETECTION AND ASSESSMENT OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZED THESE EXCURSIONS.  INTERPRETATION OF BIOGRAPHER RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P950037|S022|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|AXIOS PULSE GENERATOR FAMILY/B-K05.S.U PROGRAMMER SOFTWARE|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/28/2001|10/26/2001|||APPR|APPROVAL FOR THE AXIOS FAMILY OF PULSE GENERATORS AND THE B-K05.S.U PROGRAMMER SOFTWARE.  THE AXIOS PULSE GENERATORS ARE INDICATED AS FOLLOWS:  1) RATE-ADAPTIVE PACING WITH AXIOS PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.  2) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME.  3) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
P900039|S011|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT STRIP BONE GRAFT MATRIX|MBS|OR|Normal 180 Day Track|Express GMP Supplement|N|09/19/2001|07/02/2002|||APPR|APPROVAL FOR ADDITION MANUFACTURING SITES LOCATED AT:  BIOSERV CORPORATION, SAN DIEGO, CALIFORNIA; BIOLOGICAL TEST CENTER, B. BRAUN MEDICAL, INC., IRVINE, CALIFORNIA; NEUCOLL, INC., CAMBELL, CALIFORNIA; AND PHARMACEUTICAL SYSTEMS, INC., MUNDALEIN, ILLINOIS.
P990055|S002|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|COMPLEXED PSA MICROTITER ELISA|NAF|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/20/2001|03/19/2002|||APPR|APPROVAL TO ADD A MICROTITER PLATE CAPTURE SYSTEM TO THE CURRENT DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONCOGENE SCIENCE COMPLEXED PSA MICROTITER ELISA AND IS INDICATED FOR THE FOLLOWING:  THE ONCOGENE SCIENCE COMPLEXED PSA MICROTITER ELISA IS AN IN VITRO DIAGNOSTIC ASSAY INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PSA (CPSA) IN HUMAN SERUM.  THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM CPSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THE ONCOGENE SCIENCE COMPLEXED PSA MICROTITER ELISA IS FURTHER INDICATED FOR FOLLOW-UP AND MONITORING OF PATIENTS WITH PROSTATE CANCER.  CPSA LEVELS MEASURED BY THIS DEVICE SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL AND OTHER DIAGNOSTIC PROCEDURES IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
P950021|S004|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TOTAL PSA MICROTITER ELISA|LTJ|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/20/2001|03/19/2002|||APPR|APPROVAL TO ADD A MICROTITER PLATE CAPTURE SYSTEM TO THE CURRENT DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA AND IS INDICATED FOR THE FOLLOWING:  THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS AN IN VITRO DIAGNOSTIC ASSAY INTENDED TO QUANTITATIVELY MEASURE TOTAL PSA IN HUMAN SERUM.  THE ASSAY DETECTS PSA BOTH AS A FREE MOLECULE, AND WHEN COMPLEXED BY OTHER MOLECULES, PRINCIPALLY ALPHA-1-ANTICHYMOTRYPSIN (ACT).  THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THE ONCOGENE SCIENCE TOTAL PSA MICROTITER ELISA IS FURTHER INDICATED FOR FOLLOW-UP AND MONITORING OF PATIENTS WITH PROSTATE CANCER.  PSA LEVELS MEASURED BY THIS DEVICE SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL AND OTHER DIAGNOSTIC PROCEDURES IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
P990055|S003|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|COMPLEXED PSA MICROTITER ELISA|NAF|IM|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2001|03/13/2002|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT BAYER DIAGNOSTICS, ELKHART, INDIANA AND ONCOGENE SCIENCE, CAMBRIDGE, MASSACHUSETTS.
P950021|S005|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|TOTAL PSA MICROTITER ELISA|LTJ|IM|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2001|03/13/2002|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT BAYER DIAGNOSTICS, ELKHART, INDIANA AND ONCOGENE SCIENCE, CAMBRIDGE, MASSACHUSETTS.
P000010|S001|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900||COBAS AMPLICOR HCV TEST, V2.0||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2001|10/12/2001|||OK30|CHANGE IN QUALITY CONTROL SPECIFICATIONS.
P000012|S001|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2001|10/12/2001|||OK30|CHANGE IN QUALITY CONTROL SPECIFICATIONS.
P000020|S005|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|BARD STINGER AND STINGER S ABLATION CATHETER AND TEMPLINK EXTENSION CABLE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/24/2001|11/21/2001|||APPR|APPROVAL FOR USE OF THE BARD STINGER AND STINGER S ABLATION CATHETER AND TEMPLINK EXTENSION CABLE FOR USE WITH THE CORDIS STOCKERT 70W RF GENERATOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.
P990001|S008|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|DEMA/DIVA IMPLANTABLE PULSE GENERATORS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2001|10/24/2001|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P980016|S021|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE|LWS|CV|Normal 180 Day Track||N|09/06/2001|12/21/2001|||APPR|APPROVAL FOR THE MODEL 2490A CARELINK MONITOR WITH MODEL 2491 DDMA SERVER-RESIDENT SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 2490A CARELINK MONITOR AND IS INDICATED FOR USE IN THE TRANSFER OF PATIENT DATA FROM MEDTRONIC GEM II ICDS (GEM II VR MODEL 7229 AND GEM II DR MODEL 7273).
P010015|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC IMPLANTABLE PULSE GENERATORS, MODEL 8040|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2001|10/24/2001|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P980016|S022|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112|||GEM DR, GEM II VR, GEM II DR, AND GEM III IMPLANTABLE CARDIOVERTER DEFIBRILLATORS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2001|10/24/2001|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P980050|S009|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC JEWEL AF ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2001|10/24/2001|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P970012|S011|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|KAPPA 400 IMPLANTABLE PULSE GENERATOR|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2001|10/24/2001|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P980035|S012|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112|||MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2001|10/24/2001|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P000011|S005|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|BIODIVYSIO AS OTW|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2001|10/22/2001|||OK30|AMENDING EXISTING PROCEDURES TO IMPROVE THE INSPECTION OF STENTS AFTER LASER CUTTING, PRIOR TO AND AFTER ELECTROPOLISHING; AND ADDITION OF THE UNIVERSAL STENT CRIMPER.
P990052|S006|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE SYSTEM|MPV|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2001|10/26/2001|||APPR|APPROVAL FOR DESIGN CHANGES TO THE AUDIO PROCESSOR MODEL 404.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VIBRANT(R) SOUNDBRIDGE(TM) AUDIO PROCESSOR MODEL 404SR.  THE INDICATIONS FOR USE FOR THE DEVICE HAVE NOT CHANGED.
P900061|S048|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2001|10/24/2001|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P890003|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC/VITATRON CARELINK PROGRAMMER|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/2001|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P980035|S013|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE|NVZ|CV|Panel Track|Change Design/Components/Specifications/Material|N|09/17/2001|03/26/2003|03M-0190|05/09/2003|APPR|APPROVAL FOR THE MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE.  THE MEDTRONIC AT500 DDDRP PACING SYSTEM IS INDICATED FOR THE FOLLOWING:  1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY.  2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: A)SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK.  B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK.  C)  SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS.  D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS. THE MEDTRONIC AT500 SYSTEM IS ALSO INDICATED FOR DUAL CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE:  1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT.  2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.  ANTITACHYCARDIA PACING (ATP) IS INDICATED FOR TERMINATION OF ATRIAL TACHYARRHYTHMIAS IN BRADYCARDIA PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.  ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS) ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN BRADYCARDIA PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P990046|S005|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2001|06/07/2002|||APPR|APPROVAL TO COMBINE THE ATS OPEN PIVOT BILEAFLET HEART VALVE (APPROVED ON OCTOBER 13, 2000 UNDER P990046) WITH THE MEADOX HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT (APPROVED ON MAY 11, 1993 UNDER P840029/S005).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT, MODELS 502AG21 THROUGH 502AG29, AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES, WHERE A REPLACEMENT VALVE AND REPLACEMENT OR REPAIR OF THE AORTA IS REQUIRED.
P990009|S011|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/25/2001|10/31/2001|||APPR|APPROVAL FOR AN ALTERNATE KIT CONFIGURATION THAT DOES NOT CONTAIN THE THROMBIN COMPONENT.
P860022|S053|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens,contact(rigid gas permeable)-extended wear|BOSTON EQUALENS/BOSTON EQUALENS II|MWL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2001|11/21/2001|||APPR|APPROVAL FOR WET SHIPPING AND UP TO 30 DAYS STORAGE IN BOSTON ADVANCE COMFORT FORMULA CONDITIONING SOLUTION.
P990035|S004|BEAM-MED LTD|8 HALAPID STR.||PETACH TIKVA||49170||Bone sonometer|SUNLIGHT OMNISENSE 7000S|MUA|RA|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2001|11/30/2001|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AR RND NETWORKS LTD, JERUSALEM, ISREAL.
P850064|S017|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/2001|09/05/2002|||APPR|APPROVAL FOR A NEW PATIENT BOX.
P990017|S028|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2001|12/17/2001|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS OF THE CONTRALATERAL PULL WIRE.
P990001|S009|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|DEMA/DIVA IMPLANTABLE PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/2001|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P900061|S049|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/2001|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P970058|S011|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER (CAD) SYSTEM, M100|MYN|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2001|11/13/2001|||APPR|APPROVAL FOR THE USE OF THE IMAGECHECKER M1000 WITH INPUT FROM THE GENERAL ELECTRIC MEDICAL SYSTEMS' SENOGRAPHE 2000 FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
P840024|S082|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS/ESPRIT 22|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2001|02/19/2002|||APPR|APPROVAL FOR THE ADDITION OF A RESISTOR TO THE INTEGRATED CIRCUIT FOR THE ESPRIT 22 SPEECH PROCESSOR.
P890027|S051|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR CHILDREN/ESPRIT 22|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2001|02/19/2002|||APPR|APPROVAL FOR THE ADDITION OF A RESISTOR TO THE INTEGRATED CIRCUIT FOR THE ESPRIT 22 SPEECH PROCESSOR.
P970013|S002|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PULSE GENERATORS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2001|10/25/2001|||OK30|ELIMINATINO OF THE IN-PROCESS X-RAY IMAGING OF THE MICRONY AND REGENCY SC+ PULSE GENERATORS.
P880006|S034|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|REGENCY SC+ PULSE GENERATORS|KRG|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2001|10/25/2001|||OK30|ELIMINATION OF THE IN-PROCESS X-RAY IMAGING OF THE MICRONY AND REGENCY SC+ PULSE GENERATORS.
P820060|S014|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT IMX AFP ASSAY|LOJ|IM|Special (Immediate Track)|Other Report|N|09/28/2001|09/05/2002|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
P970035|S031|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 W/DISCRETE TECHNOLOGY(TM)OTW/RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2001|03/01/2002|||APPR|APPROVAL TO UPDATE THE MEDTRONIC AVE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM LABELING TO INCLUDE 6-MONTH POST-PROCEDURE RESULTS FOR THE STUDY POPULATION.
P920015|S024|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/2001|11/02/2001|||APPR|APPROVAL FOR THE MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD.  THE DEVICE IS INDICATED FOR SINGLE LONG-TERM USE IN THE RIGHT VENTRICLE.  THIS LEAD HAS APPLICATION FOR PATIENTS IN WHICH ARRHYTHMIA MANAGEMENT SYSTEMS ARE INDICATED.
P890064|S009|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST|MAQ|MI|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2001|03/31/2003|04M-0147|04/01/2004|APPR|APPROVAL FOR THE DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST.  THE DEVICE IS INDICATED FOR:  1) TO SCREEN PATIENTS WITH ASCUS (ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE) PAP SMEAR RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY.  THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY.  2) IN WOMEN 30 YEARS AND OLDER THE HC2 HIGH-RISK HPV DNA TEST CAN BE USED WITH PAP TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES.  THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.
P860057|S018|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/2001|11/14/2003|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING MODIFICATIONS TO THE SEWING RING/SUPPORT ASSEMBLY COMPONENTS OF THE MODEL 2800 AORTIC VALVE, SIZES 19, 21, 23, 25, 27, AND 29 MM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC AND IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVES USING THE SUPRA-ANNULAR OR INTRA-ANNULAR IMPLANTATION TECHNIQUE.
P000018|S019|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE(TM) BETA-CATH(TM) SYSTEM|MOU|CV|Normal 180 Day Track||N|10/02/2001|05/02/2002|||APPR|APPROVAL FOR THE NOVOSTE BETA-CATH XL DELIVERY CATHETER (TOTAL LENGTH 267 CM.) TO BE USED WITH THE 30 AND 40 MM NOVOSTE BETA-CATH SYSTEMS.
P870024|S043|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact, orthokeratology, overnight|PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..|NUU|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/2001|06/13/2002|02M-0295|07/02/2002|APPR|APPROVAL FOR THE FOLLOWING DEVICES AND INDICATIONS:  THE PARAGON CRT (PAFLUFOCON B) AND PARAGON CRT 100 (PAGLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES FOR CORNEAL REFRACTIVE THERAPY ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES.  THE LENSES ARE INDICATED  FOR OVERNIGHT WEAR IN A CONTACT LENSES CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 6.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.75 DIOPTERS.  THE LENSES MAY BE DISINFECTED USING ONLY A CHEMICAL DISINFECTION SYSTEM.  THE PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES FOR CORNEAL REFRACTIVE THERAPY ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES.  THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN A CONTACT LENS CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 3.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.50 DIOPTERS.  THE LENSES MAY BE DISINFECTED USING ONLY A CHEMICAL DISINFECTION SYSTEM.  NOTE: TO MAINTAIN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY EFFECT OF MYOPIA REDUCTION OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE.  FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.
P980035|S014|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2001|12/14/2001|||APPR|APPROVAL FOR THE MEDTRONIC KAPPA 900/800 PACEMAKER SERIES MODELS K(DR)901, K(DR)903, K(DR)906, K(DR)921, K(DR)931, K(DR)933, K(DR)801, K(DR)803, K(DR)806, K(D)901, K(D)903, K(D)906, KVDD901, KSR901, KSR903, AND KSR906 AND MODEL 9988 SOFTWARE SERIES 1.1.  THE DEVICES ARE INDICATED FOR THE FOLLOWING:  1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY.  2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES.  3) MEDTRONIC KAPPA 900/800 SERIES PACEMAKERS ARE ALSO INDICATED FOR DUAL CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE: A) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND B) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.  4)  MEDTRONIC KAPPA 900/800 SERIES PACEMAKERS ARE ALSO INDICATED FOR VDD PACING IN PATIENTS HAVING ADEQUATE ATRIAL RATES AND THE FOLLOWING INDICATIONS: A) REQUIREMENTS FOR VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT.  THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT OR WHEN PACEMAKER SYNDROME HAS EXISTED OR IS ANTICIPATED. B) NORMAL SINUS RHYTHM AND NORMAL AV CONDUCTION IN PATIENTS NEEDING VENTRICULAR PACING INTERMITTENTLY.
P850062|S003|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|HEPATITIS DELTA SEROLOGICAL REAGENTS|ABBOTT ANTI-DELTA (EIA) ASSAY|LQI|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2001|09/05/2002|||APPR|APPROVAL FOR CHANGES TO THE ABBOTT ANTI-DELTA (EIA) MASTER LOT TESTING.
P780012|S010|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|HAVAB (R) EIA|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2001|09/05/2002|||APPR|APPROVAL TO ADD TESTING OF A SENSITIVITY PANEL TO THE DILUTION FACTOR CONFIRMATION PERFORMED IN THE TESTING OF THE HAVAB CONJUGATE AND TO ADD ADDITIONAL TESTING OF THE HAVAB EIA MASTERLOT TO PROVIDE A QUALITY CHECK OF THE FINAL PACKAGED KIT.
P790019|S012|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M (R) EIA|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2001|09/05/2002|||APPR|APPROVAL TO ADD ADDITIONAL TESTING TO THE HAVAB-M EIA MASTERLOT TO PROVIDE A QUALITY CHECK OF THE FINAL PACKAGED KIT.
P790019|S013|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2001|09/05/2002|||APPR|APPROVAL TO ADD TESTING OF A SENSITIVITY PANEL FOR QUALIFICATION OF THE HEPATITIS A VIRUS EXTRACT USED IN THE HAVAB ASSAYS TO COAT THE SOLID PHASE OF THE BEAD AND TO TIGHTEN ASSAY ACCEPTANCE SPECIFICATIONS FOR HAV ANTIGEN QUALIFICATION.
P780012|S011|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|ABBOTT HAVAB/HAVAB EIA/IMX HAVAB|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2001|09/05/2002|||APPR|APPROVAL TO ADD TESTING OF A SENSITIVITY PANEL FOR QUALIFICATION OF THE HEPATITIS A VIRUS EXTRACT USED IN THE HAVAB ASSAYS TO COAT THE SOLID PHASE OF THE BEAD AND TO TIGHTEN ASSAY ACCEPTANCE SPECIFICATION FOR HAV ANTIGEN QUALIFICATION.
P960004|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE II/FINELINE II AND THINLINE II/FINELINE II STEROX LEADS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/04/2001|10/26/2001|||APPR|APPROVAL TO CREATE SEPARATE ACCESSORY PACKS WHICH WILL INCLUDE THE MODELS 6220 AND 6221 SUTURE SLEEVES.
P790019|S014|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|ABBOTT HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2001|09/05/2002|||OK30|ADDITION OF A MANUFACTURERS WORKING CELL BANK (MWCB) AND LIMITING THE NUMBER OF CELL PASSAGES THAT CAN BE PERFORMED FOR ANTIGEN PRODUCTION USING CELLS FROM THE NEW MWCB.
P990026|S009|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|10/04/2001|11/30/2001|||APPR|APPROVAL FOR THE GLUCOWATCH ANALYZER SOFTWARE PACKAGE AS AN ACCESSORY TO THE GLUCOWATCH BIOGRAPHER.
P780012|S012|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|ABBOTT HAVAB/HAVAB EIA/IMX HAVAB|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2001|09/05/2002|||OK30|ADDITION OF A MANUFACTURERS WORKING CELL BANK (MWCB) AND LIMITING THE NUMBER OF CELL PASSAGES THAT CAN BE PERFORMED FOR ANTIGEN PRODUCTION USING CELLS FROM THE NEW MWCB.
P950008|S003|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/2001|01/23/2002|||APPR|APPROVAL FOR MODIFICATION OF THE MOLECULAR WEIGHT RANGE SPECIFICATION FOR SILIKON 1000 FROM 36,000 - 48,000 DALTON TO 32,850 - 47,000 DALTON.
P980008|S008|LASERSIGHT TECHNOLOGIES, INC.|6903 UNIVERSITY BLVD.,||WINTER PARK|FL|32792||Excimer laser system|LASERSCAN LSX EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2001|10/25/2001|||APPR|APPROVAL TO INCREASE THE PULSE RATE OF THE LASER FROM 100 TO 200 HZ.
P860019|S177|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK OVER THE WIRE PTCA CAHTHETER|LOX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2001|11/08/2001|||APPR|APPROVAL FOR THE ADDITION OF A QUALITY CDONTROL INSPECTION STEP FOR MARKER BAND PLACEMENT DURING THE MANUFACTURING PROCESS OF THE MAVERICK OVER THE WIRE PTCA CATHETER.
P960040|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM II AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2001|10/26/2001|||APPR|APPROVAL FOR THE MINOR HEADER MODIFICATION TO PRIZM II (MODELS 1860 AND 1861).
P980035|S015|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 700/600 PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Express GMP Supplement|N|10/05/2001|10/31/2001|||APPR|APPROVAL FOR ALTERNATE MANUFACTURING, PACKAGING AND STERILIZATION FACILITIES AT MEDTRONIC EUROPE S.A., TOLOCHENAZ, SWITZERLAND.
P970029|S008|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|ECLIPSE TMR HOLMIUM LASER SYSTEM|MNO|CV|Normal 180 Day Track|Express GMP Supplement|N|10/05/2001|11/29/2001|||APPR|APPROVAL FOR A CHANGE IN MANUFACTURING LOCATION TO VENTREX, INC. VENTURA, CALIFORNIA.
P000040|S002|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR. ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/09/2001|12/07/2001|||APPR|APPROVAL FOR USING MOLDING AND EXTRUDING TECHNIQUES RATHER THAN MACHINING THE COMPONENTS THAT NMAKE UP THE DISPOSABLE SHEATH OF THE HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM.
P990056|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/09/2001|02/08/2002|||APPR|APPROVAL FOR THE ADDITION OF THE ASSAY TO THE MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS TOTAL PSA IMMUNOASSAY AND ELECSYS TOTAL PSA CALSET AND ARE INDICATED AS FOLLOWS:  THE ELECSYS TOTAL PSA IMMUNOASSAY, A QUANTITATIVE IN VITRO DIAGNOSTIC TEST FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) IN HUMAN SERUM AND PLASMA, IS INDICATED FOR THE MEASUREMENT OF TOTAL PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER.  THE TEST IS FURTHER INDICATED FOR SERIAL MEASUREMENT OF TPSA TO AID IN THE MANAGEMENT OF CANCER PATIENTS.  THE ELECTROCHEMILUMIN-ESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS.
P970061|S012|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|10/09/2001|11/29/2001|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND, LTD, GALWAY, IRELAND AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND.
P990053|S003|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2001|11/09/2001|||OK30|CHANGE IN THE STERILIZATION PROCESS BY ELIMINATING THE POST STERILIZATION VISUAL INSPECTION FOR THE OXYFIRST FETAL SENSOR FS14-SERIES.  ALSO, A CHANGE IN THE SITE OF FINAL PRODUCT DISTRIBUTION FROM THE PRESENT FACILITY IN CARLSBAD, CALIFORNIA TO A TYCO DISTRIBUTION FACILITY IN ATLANTA, GEORGIA.
P870049|S031|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID FLUOROGENIC PANELS|LON|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2001|11/09/2001|||APPR|APPROVAL FOR LABELING CHANGES TO STRENGTHEN CONTRAINDICATIONS TO THE RAPID GRAM NEGATIVE PROCEDURAL MANUALS FOR BOTH MIC AND BREAKPOINT FORMATS, WHICH DESCRIBES A LIMITATION FOR PERFORMANCE CHARACTERISTICS FOR ESBL PRODUCING ORGANISMS AND A LIMITATION FOR THOSE ORGANISMS (E.G., ENTEROBACTER SPECIES) WHICH EXPRESS INDUCIBLE BETA-LACTAMASE ENZYMES.
P990016|S001|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||Bone sonometer|MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM|MUA|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2001|11/08/2001|||APPR|APPROVAL FOR A SOFTWARE UPDATE FROM V4.2.0 TO V4.2.1 AND A NEW PHANTOM (QA COUPLER).
P000005|S001|MEDITEAM AB|GOTEBORGSVAGEN 74,||SAVEDALEN||S-433|433|SOLUTION, REMOVAL, CARRIES|CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM|LMW|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/2001|02/05/2002|||APPR|APPROVAL FOR THE CARISOLV POWER DRIVE.
P950032|S027|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF (GRAFTSKIN)|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/15/2001|11/07/2001|||APPR|APPROVAL TO INTRODUCE A NEW CELL STRAIN INTO THE PRODUCTION OF APLIGRAF (I.E., HEP 010) AND A MODIFICATION OF THE METHODS FOR KERATINOCYTE DISSOCIATION.
P980016|S023|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/2001|03/01/2002|||APPR|APPROVAL FOR MEDTRONIC MODEL 7274 MARQUIS DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9966 (MARQUIS DR) APPLICATION SOFTWARE, MODEL 9990 DESKTOP SOFTWARE, MODEL 9322 PATIENT MAGNET, AND MODEL 9767/9767L TELEMETRY PROGRAMMING HEAD (TELEMETRY B).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 7274 MARQUIS DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P990066|S007|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/2001|04/12/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE SYSTEM TO PERMIT INTEGRATION AND USE OF THE IMAGECHECKER M1000-DM COMPUTER AIDED DETECTION (CAD) SYSTEM MANUFACTURED BY R2 TECHNOLOGY, INC.
P820021|S030|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|SOFTCON(VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|10/16/2001|12/12/2001|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT CIBA VISION CORP, CIDRA, PUERTO RICO.
P920014|S016|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)|DSQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|10/16/2001|11/06/2002|||APPR|APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE SNAP VE LVAS.  THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE.  IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV END STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 60 OF THE LAST 90 DAYS, AND WHO HAVE A LIFE EXPECTANCY OF LESS THAN TWO YEARS, AND WHO ARE NOT ELIGIBLE FOR CARDIAC TRANSPLANTATION.  THE DEVICE SYSTEM IS APPROVED FOR USE BOTH INSIDE AND OUTSIDE OF THE HOSPITAL.
P970004|S017|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2001|11/01/2001|||APPR|APPROVAL TO MANUFACTURE THE INTERSTIM MODELS 3080 AND 3886 LEAD KITS AND ACCESSORIES AT MEDTRONIC NEUROLOGICAL PUERTO RICO OPERATIONS, VILLALBA, PUERTO RICO.
P970020|S037|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|10/12/2001|05/01/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P010016|S001|FORTICELL BIOSCIENCE|3960 BROADWAY||NEW YORK|NY|10032||Dressing, wound and burn, interactive|ORCEL BILAYERED CELLULAR MATRIX|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/18/2001|12/06/2001|||APPR|APPROVAL FOR THE USE OF CELL LINES FS-143 AND FS-145 IN THE COMMERCIAL MANUFACTURE OF ORCEL BILAYERED CELLULAR MATRIX.
N17600|S019|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE ULTRA WRAP COLLAGEN HEMOSTAT|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/18/2001|12/06/2001|||APPR|APPROVAL FOR MANUFACTURING MODIFICATIONS TO THE AVITENE ULTRAFOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) SPONGE AND MODIFICATIONS TO THE LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AVITENE ULTRAWRAP COLLAGEN HEMOSTAT AND IS INDICATED FOR USE IN SURGICAL PROCEDURES AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P840001|S058|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2001|12/14/2001|||APPR|APPROVAL FOR THE MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTACTABLE PAIN OF THE TRUNK OR LIMBS.
P870072|S018|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/2001|04/18/2002|||APPR|APPROVAL FOR UPGRADING THE EMBEDDED SOFTWARE (FIRMWARE) FOR THE TLC-II PORTABLE VAD DRIVER FROM VERSION 4.03 TO VERSION 4.11.
P970051|S019|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/2001|03/21/2002|||APPR|APPROVAL FOR THE SP-10 BEHIND-THE-EAR SPEECH PROCESSOR WITH ACE, CIS AND SPEAK SPEECH CODING STRATEGIES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ESPRIT3G AND IS INTENDED TO BE USED WITH THE CI24M, CI24R(ST) AND CI24R(CS) COCHLEAR IMPLANTS.
P880086|S086|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|IDENTITY XL DR MODEL 5376 PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/29/2001|11/27/2001|||APPR|APPROVAL FOR THE IDENTITY PULSE GENERATOR MODEL XL DR 5376.  THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION OR ANY COMBINATION OF THESE SYMPTOMS.  RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.  DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME; CHRONIC, SYMPTOMATIC SECOND- AND THIRD DEGREE AV BLOCK; RECURRENT ADAMS-STOKES SYNDROME; AND SYMPTOMATIC BILATERAL BUNDLE BRANCH CLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IN INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST; CHRONIC ATRIAL FIBRILLATION; AND SEVERE PHYSICAL DISABILITY.
P830045|S079|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|IDENTITY PULSE GENERATOR MODEL DR 5370|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/29/2001|11/27/2001|||APPR|APPROVAL FOR THE IDENTITY PULSE GENERATOR MODEL DR 5370.  THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION OR ANY COMBINATION OF THESE SYMPTOMS.  RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.  DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME; CHRONIC, SYMPTOMATIC SECOND- AND THIRD DEGREE AV BLOCK; RECURRENT ADAMS-STOKES SYNDROME; AND SYMPTOMATIC BILATERAL BUNDLE BRANCH CLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IN INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST; CHRONIC ATRIAL FIBRILLATION; AND SEVERE PHYSICAL DISABILITY.
P950032|S028|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APILGRAF(GRAFTSKIN)|MGR|SU|Normal 180 Day Track|Other Report|N|10/24/2001|01/17/2002|||APPR|APPROVAL FOR REMOVAL OF THE CMV IGG ANTIBODY TEST FROM THE ANTEPARTUM MATERNAL DONOR SERUM TESTING PANEL, WHILE CONTINUING TO TEST THE MATERNAL DONOR SERA FOR CMV IGM ANTIBODIES AND THE MASTER CELL BANK FOR CMV VIA PCR.
P900033|S008|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/2001|04/19/2002|02M-0216|05/13/2002|APPR|APPROVAL FOR THE INTEGRA DERMAL REGENERATION TEMPLATE.  THIS DEVICE IS INDICATED FOR "THE POSTEXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL-THICKNESS THERMAL INJURIES WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT.  INTEGRA DERMAL REGENERATION TEMPLATE IS ALSO INDICATED FOR THE REPAIR OF SCAR CONTRACTURES WHEN OTHER THERAPIES HAVE FAILED OR WHEN DONOR SITES FOR REPAIR ARE NOT SUFFICIENT OR DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT."
P980008|S009|LASERSIGHT TECHNOLOGIES, INC.|6903 UNIVERSITY BLVD.,||WINTER PARK|FL|32792||Excimer laser system|LASERSCAN LSX EXCIMER LASER SYSTEM|LZS|OP|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2001|11/09/2001|||APPR|APPROVAL FOR A CHANGE TO THE QUALITY CONTROL PROCESS THAT WILL EXTEND THE BEAM REPEATABILITY TEST FROM 2 TO 8 HOURS TO MORE ACCURATELY RESEMBLE ACTUAL FIELD USE.
P900061|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM ICD|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/2001|11/14/2001|||APPR|APPROVAL FOR THE GENERAL USE INDICATION FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS 7227CX, 7227B, 7227D AND 7227E AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
N16420|S006|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION|MENTOR POLYTEF PASTE /FOR INJECTION|LTG|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2001|11/21/2001|||APPR|APPROVAL FOR RELOCATION OF THE FORMULATION OF THE BULK PASTE AND THE EQUIPMENT AND PROCESSES ASSOCIATED WITH COMPOUNDING TO MENTOR, MINEAPOLIS, MINNISOTA.
P990066|S008|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|MOBILE SENOGRAPHE 2000D|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/26/2001|12/18/2001|||APPR|APPROVAL TO MAKE A MOBILE VERSION OF THE DEVICE, THAT IS CAPABLE OF MOVING FROM PLACE TO PLACE IN AN AIR-RIDE VAN AND ABLE TO TRANSMIT IMAGES FROM THESE LOCATIONS VIA A WIRELESS COMMUNICATIONS LINK.
P950029|S015|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|TALENT AND BRIO PACEMAKERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2001|11/26/2001|||APPR|APPROVAL TO CHANGE THE SILICONE HEADER CURRENTLY IN USE WITH THE SINGLE CHAMBER TALENT AND BRIO DEVICES TO TECOTHANE 75D POLYURETHANE HEADER (RIGID HEADER).
P910023|S057|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|IDENTITY SR MODEL 5172 PULSE GENERATOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/29/2001|11/27/2001|||APPR|APPROVAL FOR THE IDENTITY PULSE GENERATOR MODEL SR 5172.  THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION OR ANY COMBINATION OF THESE SYMPTOMS.  RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.  DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME; CHRONIC, SYMPTOMATIC SECOND- AND THIRD DEGREE AV BLOCK; RECURRENT ADAMS-STOKES SYNDROME; AND SYMPTOMATIC BILATERAL BUNDLE BRANCH CLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IN INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF AV BLOCK OR SINUS ARREST; CHRONIC ATRIAL FIBRILLATION; AND SEVERE PHYSICAL DISABILITY.
P950009|S005|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|FOCALPOINT SYSTEMCREENING SYSTEM|MNM|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/2001|11/02/2001|||APPR|APPROVAL FOR NAME CHANGES FROM AUTPAP PRIMARY SCREENING SYSTEM AND AUTOPAP SYSTEM TO FOCALPOINT SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FOCALPOINT SYSTEM.  THE FOCALPOINT SYSTEM (AUTOPAP PRIMARY SCREENING SYSTEM) IS INDICATED FOR:  THE FOCALPOINT SYSTEM IS AN AUTOMATED CERVICEL CYTOLOGY SCREENING DEVICE INTENDED FOR USE IN INITIAL SCREENING OF CERVICAL CYTOLOGY CLIDES.  THE FOCALPOINT SYSTEM IDENTIFIES UP TO 25% OF SUCCESSFULLY PROCESSED SLIDES AS REQUIRING NO FURTHER REVIEW.  THE FOCALPOINT SYSTEM ALSO IDENTIFIES AT LEAST 15% OF ALL SUCCESSFULLY PROCESSED SLIDES FOR A SECOND MANUAL REVIEW.  THE DEVICE IS INTENDED TO BE USED ON BOTH CONVENTIONALLY-PREPARED AND PREPSTAIN SYSTEM CERVICAL CYTOLOGY SLIDES.  FOR BOTH PREPARATION METHODS, THE DEVICE IS INTENDED TO DETECT SLIDES WITH EVIDENCE OF SQUAMOUS CARCINOMA AND ADENOCARCONOMA AND THEIR USUAL PRECURSOR CONDITIONS; IT IS NOT INTENDED TO BE USED ON SLIDES DESIGNATED BY THE LABORATORY AS HIGH RISK.  INTENDED USERS ARE TRAINED CYTOLOGY LABORATORY PERSONNEL OPERATING UNDER THE DIRECT SUPERVISION OF A QUALIFIED CYTOLOGY SUPERVISOR OR LABORATORY MANAGER/DIRECTOR.
P970018|S003|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/26/2001|11/02/2001|||APPR|APPROVAL FOR NAME CHANGES FROM AUTOCYTE PREP SYSTEM TO PREPSTAIN SYSTEM AND FROM CYTORICH TO SUREPATH.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PREPSTAIN SYSTEM AND SUREPATH.  THE PREPSTAIN SYSTEM AND SUREPATH IS INDICATED AS A LIQUID-BASED, THIN LAYER CELL PREPARATION PROCESS.  THE PREPSTAIN SYSTEM PRODUCES SLIDES THAT ARE INTENDED AS REPLACEMENTS FOR CONVENTIONAL GYNECOLOGIC PAP SMEARS.  THE PREPSTAIN SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER, PRECANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES.
P910073|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK: DSP, ENDURANCE EZ, AND ENDURANCE RX LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2001|01/11/2002|||APPR|APPROVAL FOR THE PEEK SUPPORT CLIP FOR THE ENDOTAK DSP LEAD MODELS 0094, 0095, 0125, ENDOTAK ENDURANCE LEAD MODELS 0134, 0135, 0136 AND ENDOTAK ENDURANCE EZ LEAD MODELS 0154, 0155 AND 0156.
P900052|S010|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM|LNY|HO|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2001|06/11/2002|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT THE FINISHING/POLISHING FACILITY LOCATED AT ELTRONIC, COON RAPIDS, MINNESOTA.
P980049|S006|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALTO ICD MODELS 614 AND 615|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2001|12/21/2001|||APPR|APPROVAL FOR ALTO ICD MODELS 614 AND 615.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALTO DR MODEL 614 ICD AND ALTO VR MODEL 615, AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS:  1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA;  2) RECURRENT, POORLY TOLERATED, SUSTAINED VENTRICULAR TACHYCARDIA (VT).  NOTE: THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE VT PATIENTS IS NOT FULLY KNOWN.  SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.
P790018|S038|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700|LWQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P900043|S030|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/2001|04/29/2002|||APPR|APPROVAL FOR THE BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<=30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM; AND  2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM.  THE 2.25 MM, 2.5 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
P960007|S016|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE|MGR|SU|Real-Time Process|Postapproval Study Protocol - ODE/OIR|N|11/05/2001|12/26/2001|||APPR|APPROVAL FOR THE CEASING OF ENROLLMENT OF NEW PATIENTS IN THE POST-MARKET APPROVAL STUDY: TC-01-07-0597 "AN OPEN LABEL STUDY TO EVALUATE THE INCIDENCE OF WOUND INFECTION IN PATIENTS REQUIRING A TEMPORARY COVERING FOR EXCISED BURN WOUNDS"
P790018|S039|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700|LWQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/04/2001|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT MEDTRONIC, INC., SPRING LAKE PARK, MINNESOTA.
P870049|S032|DADE INTL., INC.|1584 ENTERPRISE BLVD.||WEST SACRAMENTO,|CA|95691||SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION|MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS|LON|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/2001|11/30/2001|||APPR|APPROVAL FOR LABELING CHANGES TO THE RAPID GRAM POSITIVE PROCEDURAL MANUALS FOR INTERPRETIVE CRITERIA FOR PENICILLIN AND AMPICILLIN WHEN TESTING STREPTOCOCCUS SPECIES OTHER THAN STREPTOCOCCUS PNEUMONIA.
P790017|S076|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|STORMER OVER THE WIRE BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/2001|04/19/2002|||APPR|APPROVAL FOR THE MEDTRONIC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER.
P990086|S003|SANUWAVE, INC.|11680 GREAT OAKS WAY|SUITE 350|ALPHARETTA|GA|30022||Generator, shock-wave, for pain relief|HEALTHTRONICS OSSATRON|NBN|PM|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/2001|03/14/2003|03M-0173|05/01/2003|APPR|APPROVAL FOR THE HEALTHTRONICS OSSATRON.  THE DEVICE IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE (ESW) TREATMENT IN PATIENTS WITH CHRONIC LATERAL EPICONDYLITIS (TENNIS ELBOW) THAT HAS FAILED TO RESPOND TO CONSERVATIVE TREATMENT.  CHRONIC LATERAL EPICONDYLITIS IS DEFINED AS LATERAL EPICONDYLITIS THAT HAS PERSISTED FOR 6 MONTHS OR MORE WITH A HISTORY OF UNSUCCESSFUL CONSERVATIVE TREATMENT.
P920047|S015|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2001|04/18/2002|||APPR|APPROVAL FOR NEW INDICATIONS FOR USE FOR ONE DEVICE COMPONENT OF THE EPT-1000 CARDIAC ABLATION SYSTEM.  THE DEVICE COMPONENT, AS MODIFIED, WILL, BE MARKETED UNDER THE TRADE NAME EPT-1000 TC CARDIAC ABLATION CONTROLLER WITH TEMPERATURE CONTROL AND IS INDICATED FOR USE IN CONJUNCTION WITH THE APPROPRIATE RADIOFREQUENCY ABLATION CATHETER FOR CARDIAC ABLATION PROCEDURES.
P970004|S018|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/05/2001|||APPR|APPROVAL FOR ADDING AN ADDITIONAL METHOD FOR MONITORING ETHYLENE OXIDE GAS CONCENTRATIONS DURING THE STERILIZATION PROCESS.
P000027|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/2001|04/29/2002|||APPR|APPROVAL FOR THE ADDITION OF THE ELECSYS FREE PSA ASSAY TO THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS FREE PSA IMMUNOASSAY, ELECSYS FREE PSA CALSET AND ELECSYS FREE PSA CALCHECK AND ARE INDICATED AS FOLLOWS:  IMMUNOASSAY FOR THE IN VITRO QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN IN HUMAN SERUM AND PLASMA.  THE ELECSYS FREE PSA IMMUNOASSAY IS INDICATED FOR MEASUREMENT OF FPSA IN CONJUNCTION WITH THE ELECSYS TOTAL PSA TO DEVELOP A RATIO (% FPSA) OF FPSA TO TPSA.  THIS RATIO IS USEFUL WHEN USED IN CONJUNCTION WITH THE ELECSYS TOTAL PSA TEST AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN  PROSTATE CONDITIONS IN MEN AGE 50 YEARS OR OLDER WHO HAVE A DIGITAL RECTAL EXAMINATION (DRE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND AN ELECSYS TOTAL PSA VALUE IN THE RANGE 4-10NG/ML.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS.  ELECSYS FREE PSA CALSET IS USED FOR CALIBRATING THE QUANTITATIVE ELECSYS FREE PSA ASSAY ON THE ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY SYSTEMS.  FREE PSA CALCHECK IS FOR USE IN THE VERIFICATION OF THE CALIBRATION ESTABLISHED BY THE ELECSYS FREE PSA REAGENT ON ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS.
P830055|S081|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2001|02/05/2002|||APPR|APPROVAL FOR ALLOWING THE MBT REVISION TIBIAL TRAY AND TRAY COMPONENTS, E.G., AUGMENTS, STEM EXTENSIONS, TIBIAL SLEEVES, AND WEDGES, TO BE USED WITH THE ORTHOGENESIS LPS TIBIAL HINGE BEARINGS THAT WERE CLEARED IN K011810.
P910023|S058|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ATLAS DR/VR IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2001|12/21/2001|||APPR|APPROVAL FOR THE ATLAS(TM) DR/VR (MODELS V-240 AND V-199) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTWARE VERSION 3.1.  THESE DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P880086|S087|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2001|12/21/2001|||APPR|APPROVAL FOR THE ATLAS (TM) DR/VR (MODELS V-240 AND V-199) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTWARE VERSION 3.1.  THESE DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P830045|S080|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2001|12/21/2001|||APPR|APPROVAL FOR THE ATLAS DR/VR (MODELS V-240 AND V-199) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTWARE VERSION 3.1.  THESE DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION,FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P960009|S022|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2001|12/11/2001|||APPR|APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE AN ADDITIONAL METHOD FOR MONITORING ETHYLENE GAS CONCENTRATIONS DURING THE STERILIZATION PROCESS.
P840001|S059|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC SPINAL CORD STIMULATION SYSTEM|LGW|NE|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2001|12/11/2001|||APPR|APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE AN ADDITIONAL METHOD FOR MONITORING ETHYLENE GAS CONCENTRATIONS DURING THE STERILIZATION PROCESS.
P810046|S210|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|POWERSAIL/HIGHSAIL CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/2001|02/15/2002|||APPR|APPROVAL FOR MODIFICATIONS IN MANUFACTURING PROCESS OF THE POWERSAIL AND HIGHSAIL PTCA CATHETERS.
P830063|S004|BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|GAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N|MDP|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/2001|05/10/2002|||APPR|APPROVAL FOR THE PERMANENT BONDING OF TUBING LINES ONTO THE PLASMAFILTER PF2000N.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISM TPE 2000 SET, AND IS INDICATED FOR USE IN PERFORMING THERAPEUTIC PLASMA SEPARATION FROM WHOLE BLOOD IN A CLINICAL SETTING TO REMOVE CIRCULATING PLASMA COMPONENTS OR PROTEIN BOUND TOXINS.
P890003|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|THERA/THERA-I FAMILY OF PULSE GENERATORS|DXY|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P970035|S032|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2001|01/31/2002|||APPR|APPROVAL FOR THE MEDTRONIC AVE S660 2.75 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF ACUTE OR THREATENED CLOSURE DURING A PLANNED INTERVENTIONAL PROCEDURE IN DE NOVO LESIONS (<=24 MM IN LENGTH) IN NATIVE CORONARY ARTERY OR ARTERIAL BYPASS GRAFT CONDUIT WITH A REFERENCE DIAMETER BETWEEN 2.2 MM AND 2.9 MM.  LONG-TERM OUTCOME (BEYOND 30 DAYS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT.
P960040|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2001|04/23/2003|||APPR|APPROVAL FOR VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (VITALITY DR MODEL 1871, VITALITY VR MODEL 1870 AND VITALITY + DR MODEL 1872), AND MODEL 2857 SOFTWARE, VERSION 1.5.  THE DEVICE IS INDICATED FOR USE IN THE FOLLOWING:  THE VITALITY AICD SYSTEM IS INTENDED TO PROVIDE THERAPY FOR THE AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT AICD INCLUDE:  1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR  2)  PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <= 30% (AS DEFINED IN THE MADIT II CLINICAL STUDY APPENDIX).
P990074|S010|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2001|12/12/2001|||OK30|ELIMINATION OF DESTRUCTIVE FINISHED PRODUCT RELEASE TESTING (FPRT) BASED ON AN ASSESSMENT OF THE CRITICAL CONTROL POINTS OF THE MANUFACTURING PROCESS BY THE HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) METHOD.
P860064|S010|C.R. Bard, Inc.|605 N 5600 W||SALT LAKE CITY|UT|84116||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|DUPEN LONG-TERM EPIDURAL CATHETER|LNY|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2001|12/07/2001|||OK30|MANUFACTURING CHANGE IN ETO STERILIZATION CYCLE PARAMETERS.
P990066|S009|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2001|06/05/2002|||APPR|APPROVAL FOR THE ADDITION OF GRME AS AN ALTERNATIVE SUPPLIER OF THE GENERATOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM.
P970004|S019|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2001|12/14/2001|||OK30|CHANGE IN THE STERILE PACKAGING OPERATION FROM A CLASS 10,000 CONTROLLED ENVIRONMENT AREA (CEA) TO A CLASS 100,000 CEA.
P990066|S010|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2001|12/03/2001|||APPR|APPROVAL FOR A MODIFIED CONTROL CONSOLE INCLUDING MINOR HARDWARE AND SOFTWARE MODIFICATIONS TO THE APPROVED SYSTEM.  THE SUPPLEMENT ALSO INCLUDES APPROPRIATE CHANGES IN THE LABELING TO REFLECT THESE CHANGES.
P960004|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FINELINE II STEROX  LEADS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2001|12/18/2001|||APPR|APPROVAL FOR USE OF DEXAMETHASONE ACETATE (DXA) AS AN ALTERNATE STEROID COLLAR ON THE FINELINE II STEROX LEAD MODELS 4456, 4457, 4458, 4459, 4469, 4470, 4471, 4472, 4473, 4479 AND 4480.
P790018|S040|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2001|12/19/2001|||OK30|ADDITION OF AN ALTERNATE STEAM (AUTOCLAVE) STERILIZER WITH A CHANGE IN STERILIZATION TIME FROM 24 TO 40 MINUTES.
P790018|S041|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/2001|04/23/2002|||APPR|APPROVAL FOR A CHANGE TO THE COUNTRY OF ORIGIN FOR THE COLLAGEN USED IN THESE PRODUCTS.  THE INTENT OF THE CHANGE IS TO SOURCE THE COLLAGEN FROM A COUNTRY THAT IS FREE FROM BOVINE SPONGIFORM ENCEPHALOPATHY (BSE).
P000020|S006|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER S, STINGER M, STINGER SM ABLATION CATHETERS|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/19/2001|01/28/2002|||APPR|APPROVAL TO ADD THE REUSE CLAIM TO THE LABELING FOR THE BARD ELECTROPHY AN M EXTENSION CABLES.
P880081|S027|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL'S|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|11/19/2001|05/01/2002|||APPR|APPROVAL FOR THE ALTERNATE STERILIZATION FACILITY LOCATED AT EDWARDS LIFESCIENCES LLC, ANASCO, PUERTO RICO.
P960028|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY MULTIFOCAL ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL|MFK|OP|Normal 180 Day Track|Express GMP Supplement|N|11/19/2001|05/01/2002|||APPR|APPROVAL FOR THE ALTERNATE STERILIZATION FACILITY LOCATED AT EDWARDS LIFESCIENCES LLC, ANASCO, PUERTO RICO.
P980040|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|ALLERGAN SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|11/19/2001|05/01/2002|||APPR|APPROVAL FOR THE ALTERNATE STERILIZATION FACILITY LOCATED AT EDWARDS LIFESCIENCES LLC, ANASCO, PUERTO RICO.
P990026|S010|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/19/2001|11/30/2001|||APPR|APPROVAL FOR EXTENDED SHELF LIFE OF THE QC TEST SOLUTION FROM 6 MONTHS TO 24 MONTHS.
P960043|S035|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/19/2001|12/28/2001|||APPR|APPROVAL FOR A MODIFICATION OF THE CLOSER S SUTURE-MEDIATED CLOSURE (SMC) DEVICE TO ALLOW FOR A PRE-TIED KNOT UPON DEVICE USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS.  THE CLOSER II 6 FR. SMC SYSTEM REDUCES THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS.
P000052|S001|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2001|12/18/2001|||OK30|MODIFICATION OF A MANUFACTURING PROCESS, INCORPORATING ADDITIONAL ENVIRONMENTAL CONTROLS, FOR THE GDT-P32-2 (27 MM) SOURCE WIRE COMPONENT OF THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM.
P990030|S002|ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Agent, absorbable hemostatic, collagen based|COSTASIS/DYNASTAT SURGICAL HEMOSTAT|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/20/2001|12/21/2001|||APPR|APPROVAL FOR MODIFICATIONS TO THE COSTASIS(R)/DYNASTAT(TM) SURGICAL HEMOSTATS' PRODUCT LABELING.
P010023|S001|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|SOUNDTEC DIRECT IPCA SYSTEM|MPV|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2001|09/04/2002|||APPR|APPROVAL FOR THE SOUNDTEC DIRECT IPCA SYSTEM.  THE INDICATIONS FOR USE HAS NOT BEEN CHANGED.
P920047|S016|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2001|12/18/2001|||OK30|USE OF A CURRENT VENDOR, MEMRY CORPORATION IN BETHEL, CONNECTICUT, TO PRODUCE STEERING WIRE SUBASSEMBLIES CURRENTLY MANUFACTURED IN-HOUSE AT BOSTON SCIENTIFIC CORPORATION.
P970020|S038|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/23/2001|05/22/2002|||APPR|APPROVAL FOR INCLUSION OF SIX-MONTH TRIAL DATA IN THE INSTRUCTIONS FOR USE BOOKLET FOR THE MULTI-LINK RX AND OTW PENTA CORONARY STENT SYSTEMS.  THE MULTI-LINK RX AND OTW PENTA CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH REFERENCE VESSEL DIAMETERS OF 3.0 MM TO 4.0 MM;  2) PATIENTS WITH SYMPTOMATIC  ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <= 35 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 TO 4.0 MM; AND  3) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 2.5 MM TO 4.0 MM.  LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  NOTE: THE 2.5 MM AND 2.75 MM DIAMETER STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE.  THE 33 MM AND 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS  WITH ABRUPT OR THREATENED ABRUPT CLOSURE AND PATIENTS WITH LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS.
P860004|S048|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PROGRAMMABLE INFUSION PUMPS|LKK|HO|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/05/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P980035|S016|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|KAPPA 700/600, SIGMA AND 350 SERIES FAMILIES OF PULSE GENERATORS|DXY|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P900061|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM ICD/IPG|LWS|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P980016|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II FAMILY OF ICD/PULSE GENERATORS|LWS|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P970012|S012|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|KAPPA 400|DXY|CV|Special (Immediate Track)||N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P920015|S025|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT FAMILY OF LEADS|LWS|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P950024|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE EPI 4965/4968|DTB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P990001|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|DEMA/DIVA IMPLANTABLE PULSE GENERATORS|DXY|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P980050|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT MODEL 7276 ICD/PULSE GENERATORS|LWS|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P830061|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE FAMILY OF LEADS/ACCESSORIES|DTB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P010015|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC IPG MODEL 8040 BIVENTRICULAR PULSE GENERATOR SYSTEM|LWP|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P010015|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN OTW MODEL 4193|LWP|CV|Normal 180 Day Track||N|11/19/2001|05/02/2002|||APPR|APPROVAL FOR THE ATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD.  THE MODEL 4193 IS INDICATED FOR USE AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.
P850089|S049|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE AND CAPSURE NOVUS FAMILIES OF LEADS/ACCESSORIES|DTB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P850089|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE SP MODEL 5024M AND SUREFIX MODEL 5072 LEADSRIES|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2001|12/19/2001|||APPR|APPROVAL FOR THE FOLLOWING:  1) A CHANGE IN OUTER INSULATION TREATMENT FROM SILACURE TO SILOXANE FOR THE CAPSURE SP MODEL 5024M LEAD;  2) A MATERIAL CHANGE FROM MDX SILICONE TO MED 4719 SILICONE FOR SUREFIX MODEL 5072 INNER AND OUTER INSULATION (OUTER INSULATION WITH SILOXANE TREATMENT); AND  3) ASSOCIATED MINOR LABELING CHANGES.
P930039|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSUREFIX FAMILY OF LEADS|DTB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2001|12/11/2001|||APPR|APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
P930039|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSURE SP MODEL 5024M|DTB|CV|Real-Time Process|Other Report|N|11/14/2001|12/19/2001|||APPR|APPROVAL FOR THE FOLLOWING:  1) A CHANGE IN OUTER INSULATION TREATMENT FROM SILACURE TO SILOXANE FOR THE CAPSURE SP MODEL 5024M LEAD;  2) A MATERIAL CHANGE FROM MDX SILICONE TO MED 4719 SILICONE FOR SUREFIX MODEL 5072 INNER AND OUTER INSULATION (OUTER INSULATION WITH SILOXANE TREATMENT); AND  3) ASSOCIATED MINOR LABELING CHANGES.
P980016|S025|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2001|01/18/2002|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE CONNECTOR ASSEMBLY FOR THE GEM DR MODEL 7271, GEN II DR MODEL 7273 AND GEM III DR MODEL 7275.
P980050|S011|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT MODEL 7276|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2001|01/18/2002|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE CONNECTOR ASSEMBLY FOR THE GEM III AT MODEL 7276.
P970020|S039|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX TETRA/OTW TETRA CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track||N|11/27/2001|05/23/2002|||APPR|APPROVAL FOR INCLUSION OF SIX-MONTH TRIAL DATA IN THE INSTRUCTIONS FOR USE BOOKLET FOR THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS.  THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH REFERENCE VESSEL DIAMETERS OF 3.0 MM TO 4.0 MM;  2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <= 35 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 TO 4.0 MM; AND  3)  TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 2.5 MM TO 4.0 MM.  LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  NOTE:  THE 2.5 MM AND 2.75 MM DIAMETER STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE.  THE 33 MM AND 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE AND PATIENTS WITH LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS.
P000052|S002|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|11/27/2001|04/19/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.  THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE NOVEMBER 2, 2001 APPROVAL ORDER FOR P000052.
P990018|S002|MENICON CO. LTD.|269 A BALLARDVALE STREET||WILMINGTON|MA|01887||Lens,contact(rigid gas permeable)-extended wear|MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR|MWL|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2001|07/12/2002|02M-0335|08/06/2002|APPR|APPROVAL FOR THE MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS.  THIS DEVICE IS INDICATED FOR:  MENICON Z (TISILFOCON A) SPHERICAL, ASPHERIC, NON-PRISM BALLAST TORIC AND NON-PRISM BALLAST MULTIFOCAL LENSES ARE INDICATED FOR EXTENDED WEAR (FROM 1 TO 30 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OF THE LENSES, AS RECOMMENDED BY THE EYECARE PROFESSIONAL) FOR THE CORRECTION OF REFRACTIVE ERROR (MYOPIA, HYPEROPIA, PRESBYOPIA AND/OR ASTIGMATISM) IN NON-APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENS MAY BE PRESCRIBED IN SPHERICAL AND ASPHERIC POWERS RANGING FROM -25.00 D TO +25.00 D FOR DAILY WEAR AND        -25.00 D TO +8.00 D FOR UP TO 30 DAYS  EXTENDED WEAR.  TORIC LENSES ARE DESIGNED TO CORRECT UP TO 5.00 D OF ASTIGMATISM AND MULTIFOCAL LENSES TO PROVIDE UP TO +3.00 D OF READING ADD POWER FOR UP TO 30 DAYS EXTENDED WEAR.  THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY.  (THE MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS WAS CLEARED FOR DAILY WEAR UNDER K962006, K970019 AND K972443).
P990037|S007|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2001|12/31/2001|||APPR|APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT STRATIFIES ADVERSE EVENTS INTO DIAGNOSTIC AND INTERVENTIONAL PATIENT POPULATIONS.
P990017|S029|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2001|12/11/2001|||APPR|APPROVAL FOR TEMPORARY ADDITION OF A LABEL TO INSPECT THE CONTRALATERAL CUTTER PACKAGED WITH THE ANCURE DEVICE.  THE CHANGE WOULD APPLY TO 436 DEVICES MANUFACTURED BETWEEN OCTOBER 12, 2001 AND NOVEMBER 12, 2001.
P900056|S067|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES|MCX|CV|Normal 180 Day Track|Express GMP Supplement|N|11/29/2001|01/09/2002|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY LOCATED AT THE COSMED GROUP, INC., COVENTRY, RHODE ISLAND.
P000052|S003|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/2001|12/17/2001|||APPR|APPROVAL FOR AN ALTERNATE WHITE FOIL MATERIAL FOR USE AS FEMORAL AND BRACHIAL MARKERS ON THE CENTERING CATHETER.
P980049|S007|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ORCHESTRA PROGRAMMER|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/2001|01/11/2002|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE ELAVIEW 1.06 UGI OF THE ORCHESTRA PROGRAMMER.
P980035|S017|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC SIGMA AND MEDTRONIC 350 SERIES PULSE GENERATORS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2001|12/28/2001|||OK30|CHANGE IN THE CLEANING PROCESS TO ADD AN ATMOSPHERIC GLOW DISCHARGE PROCESS IN PLACE OF THE HEPTANE WIPE.
P010015|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM|LWP|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|12/03/2001|05/31/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.  THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE AUGUST 28, 2001 APPROVAL ORDER FOR P010015.
P970008|S018|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/03/2001|09/04/2002|||APPR|APPROVAL FOR A CHANGE FROM THE STANDARD ANTENNA (2.8 CM IN LENGTH) TO A SHORTENED VERSION (2.0 CM IN LENGTH).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM, AND IS INTENDED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASMIA (BPH), AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 2.5 TO 3.5 CM.
P860005|S012|INTERPORE INTL.|181 TECHNOLOGY DR.||IRVINE|CA|92618|2402|FILLER, BONE VOID, NON-OSTEOINDUCTION|PRO OSTEON 500 BONE GRAFT SUBSTITUTE|MBS|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2001|05/31/2002|||APPR|APPROVAL TO REPLACE STATIC COMPRESSION TESTING WITH ULTIMATE COMPRESSION TESTING DURING THE MANUFACTURING PROCESS FOLLOWING DEPYROGENATION.
P910007|S007|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ABBOTT ARCHITECT TOTAL PSA|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/2001|02/02/2004|||APPR|APPROVAL FOR THE ABBOTT ARCHITECT TOTAL PSA ASSAY.  THE ARCHITECT TOTAL PSA ASSAY IS INDICATED:  1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.  2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
P890017|S010|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLOON-EXPANDABLE STENT|MAF|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/06/2001|07/10/2002|02M-0348|08/08/2002|APPR|APPROVAL FOR THE CORDIS PALMAZ BALLOON EXPANDABLE STENT (MODELS P104R, P154R, P204R).  THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUBOPTIMAL PERCUTANEOUS RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC LESION (<=22 MM IN LENGTH) LOCATED WITHIN 10 MM OF THE AORTORENAL ARTERY BORDER AND WITH A REFERENCE VESSEL DIAMETER OF >= 4 MM AND <= 8 MM.  SUBOPTIMAL PTRA RESULTS ARE DEFINED BY ONE OR MORE OF THE FOLLOWING UNFAVORABLE RESULTS: >= 50% RESIDUAL STENOSIS BY VISUAL ESTIMATE, >= 20 MM HG PEAK TRANSLESIONAL PRESSURE GRADIENT, >= 10 MM HG MEAN TRANSLESIONAL PRESSURE GRADIENT, AND/OR GRADE D DISSECTION (A SPIRAL SHAPED FILLING DEFECT WITHIN THE LUMEN OF THE VESSEL) OR ANY DISSECTION WITH SIGNIFICANT COMPROMISE IN LUMEN FLOW.
P850079|S039|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|EXPRESSIONS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|12/06/2001|01/17/2002|||APPR|APPROVAL FOR AN ALTERNATE FACILITY FOR PAD PRINTING LOCATED AT ASPECT VISION CARE, SOUTHAMPTON, UNITED KINGDOM.
P910031|S021|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|JOMED JOCATH GLADIATOR PTCA CATHETER (OTW)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/2001|08/01/2003|||APPR|APPROVAL FOR THE JOMED JOCATH GLADIATOR PTCA CATHETER (OTW).  THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P900009|S014|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM|LPQ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/07/2001|11/18/2002|||APPR|APPROVAL FOR LABELING CHANGES TO THE PHYSICIAN'S INSTRUCTIONS FOR USE.
P980009|S010|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT EDNDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|12/07/2001|01/22/2002|||APPR|APPROVAL FOR TWO ALTERNATE MANUFACTURING FACILITIES FOR PACKAGING AND LABELING OPERATIONS LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
P970061|S013|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|MAGIC WALLSTENT ENDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|12/07/2001|01/22/2002|||APPR|APPROVAL FOR TWO ALTERNATE MANUFACTURING FACILITIES FOR PACKAGING AND LABELING OPERATIONS LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
P840001|S060|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2001|01/03/2002|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P960009|S023|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2001|01/03/2002|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
P950039|S008|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSOR (MODEL TP-2000)|MKQ|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/2001|06/05/2002|||APPR|APPROVAL FOR THE PRESERVCYT SOLUTION COMPONENT OF THE THINPREP 2000 SYSTEM TO BE USED AS AN ALTERNATIVE COLLECTION AND TRANSPORT MEDIUM FOR GYNECOLOGIC SPECIMENS TESTED WITH THE ROCHE COBAS AMPLICOR CT/NG TEST.
P000052|S004|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO (TM) III INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2001|09/19/2002|||APPR|APPROVAL FOR THE GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM AND IS INDICATED AS FOLLOWS:  "THE GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM IS INTENDED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS <= 47 MM IN A REFERENCE VESSEL DIAMETER 2.4 MM TO 3.7 MM."
P990026|S011|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH 2 BIOGRAPHER|CGA|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2001|03/21/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE ELECTRICAL HARDWARE AND SOFTWARE OF THE ORIGINAL GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLUCOWATCH2 BIOGRAPHER AND IS INDICATED FOR:  THE GLUCOWATCH2 BIOGRAPHER IS A GLUCOSE MONITORING DEVICE INTENDED FOR DETECTING TRENDS AND TRACKING PATTERNS IN GLUCOSE LEVELS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES.  THIS DEVICE IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTHCARE FACILITIES.  THE DEVICE IS FOR PRESCRIPTION USE ONLY.  THE GLUCOWATCH 2 BIOGRAPHER IS INTENDED FOR USE AS AN ADJUNCTIVE DEVICE TO SUPPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.  THE GLUCOWATCH2 BIOGRAPHER IS INDICATED FOR USE IN THE DETECTION AND ASSESSMENT OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS.  INTERPRETATION OF BIOGRAPHER RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P990037|S008|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTION DUETT SEALING DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2001|05/29/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE DELIVERY CANNULAE AND THE PROCOAGULANT AND CHANGING THE BUFFERING AGENT IN THE DILUTENT TO TROMETHAMINE USP (TRIS).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DUETT FLOWABLE HEMOSTAT DEVICE AND IS INDICATED FOR USE AS ADJUNCT TREATMENT IN OBTAINING HEMOSTASIS IN SEALING RESIDUAL OOZING OF TISSUE TRACTS OF FEMORAL ACCESS SITES THAT HAVE BEEN PREVIOUSLY CLOSED BY SUTURE MEDIATED/COLLAGEN-BASED HEMOSTATIC DEVICES.
P910016|S012|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|LCS UNI TOTAL KNEE SYSTEM|MBD|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/12/2001|02/04/2002|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE TIBIAL TRAY AND TIBIAL BEARING COMPONENTS OF THE LCS UNI TOTAL KNEE SYSTEM.  THESE MODIFICATIONS INCLUDE: A CHANGE TO THE PROXIMAL ARTICULATING SURFACE OF THE TIBIAL BEARING IN ORDER TO ACCOMMODATE IT'S USE WITH THE PRESERVATION UNI FEMORAL COMPONENT; A CHANGE IN POLYETHYLENE RAW MATERIAL; A 1 MM REDUCTION IN THE DOVETAIL HEIGHT OF THE POLYETHYLENE BEARING; REFINING THE OUTER PROFILE OF THE TIBIAL TRAY TO BE LEFT/RIGHT SPECIFIC AND TO OPTIMIZE THE TIBIAL BONE COVERAGE; CEMENTED USE ONLY; REPLACING THE POROUS COATING ON THE TIBIAL TRAY WITH A GRIT-BLAST SURFACE FINISH; AND, REPLACING THE FIXATION PEG WITH A FIXATION KEEL.  THE DEVICE COMPONENTS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRESERVATION UNI MOBILE BEARING KNEE SYSTEM, AND ARE INDICATED FOR CEMENTED USE IN PATIENTS OVER 60 YEARS OLD UNDERGOING UNICOMPARTMENTAL KNEE SURGERY FOR REHABILITATING KNEES WHEN ONLY ONE CONDYLE HAS BEEN DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS OR POST-TRAUMATIC ARTHRITIS.
P900009|S015|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM|LPQ|OR|Normal 180 Day Track|Express GMP Supplement|N|12/13/2001|03/29/2002|||APPR|APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT SMITH & NEPHEW, INC., MEMPHIS, TENNESSEE.
P890003|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|THERA/THERA-I|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2001|01/03/2002|||OK30|CHANGE IN A CONTROLLED ENVIRONMENTAL AREA FROM CLASS 10,000 TO A MINIMUM OF CLASS 100,000.
P990027|S004|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217A EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/14/2001|02/25/2003|03M-0174|04/28/2003|APPR|APPROVAL FOR THE TECHNOLAS 217A EXCIMER LASER SYSTEM.  THE DEVICE USES AN OPTICAL ZONE TREATMENT RANGE FROM 5.00 MM TO 6.00 MM WITH A BLEND ZONE OF 1.90 MM FOR SPHERICAL HYPEROPIA AND 1.75 MM FOR HYPEROPIC ASTIGMATISM.  THE LASER IS LOCKED OUT FOR REFRACTIVE CORRECTIONS GREATER THAN +4.00 D SPHERE AND GREATER THAN +2.00 D CYLINDER.  THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS:  1) FOR THE REDUCTION OR ELIMINATION OF LOW-TO-MODERATE NATURALLY OCCURRING HYPEROPIA UP TO +4.00 DIOPTERS (D) MRSE, WITH SPHERE BETWEEN +1.00 TO +4,00 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO +2.00 D AT THE SPECTACLE PLANE;  2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND,  3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION.
P910077|S037|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/|LWS|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|12/14/2001|07/18/2002|02M-0352|08/08/2002|APPR|APPROVAL FOR THE VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856, VENTAK PRIZM VR/DR HE MODELS 1852/1853, VENTAK MINI IV MODELS 1790/1793/1796 AND VENTAK MINI III HE MODEL 1789.  THESE DEVICES ARE INDICATED IN PATIENTS WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS.  IN ADDITION, THESE DEVICES ARE INDICATED FOR PROPHYLACTIC TREATMENT OF PATIENTS WITH A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION (EF) <=30% (AS DEFINED IN THE CLINICAL STUDY SECTION).
P960040|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM 2 VR/DR MODELS 1860/1861; VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856; VENTAK PRIZM VR/DR HE MODELS 1852|LWP|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|12/14/2001|07/18/2002|02M-0353|08/08/2002|APPR|APPROVAL FOR THE VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856, VENTAK PRIZM VR/DR HE MODELS 1852/1853, VENTAK MINI IV MODELS 1790/1793/1796 AND VENTAK MINI III HE MODEL 1789.  THESE DEVICES ARE INDICATED IN PATIENTS WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS.  IN ADDITION, THESE DEVICES ARE INDICATED FOR PROPHYLACTIC TREATMENT OF PATIENTS WITH A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION (EF) <=30% (AS DEFINED IN THE CLINICAL STUDY SECTION).
P990050|S004|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD,SUITE|11|SAN DIEGO|CA|92121||ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)|WAVSTAT OPTICAL BIOPSY SYSTEM|MOA|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/2001|06/14/2002|||APPR|APPROVAL FOR THE USE OF THE REUSABLE WAVSTAT OPTICAL BIOPSY FORCEPS WITH THE WAVSTAT OPTICAL BIOPSY SYSTEM.
P940034|S013|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST)|MWA|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2001|01/25/2002|||APPR|APPROVAL FOR CHANGES TO THE RELATIVE LIGHT UNITS (RLU) SPECIFICATION FOR THE 0.2-0.3 MM WASHED GLASS BEADS (PART NO. 101321) AND FILLED LYSING TUBES (PART NO. 102606).
P000025|S001|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+COCHLEAR IMPLANT SYSTEM,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2001|07/29/2002|||APPR|APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, C40+S (COMPRESSED) ELECTRODE ARRAY AND THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, C40+ GB (SPLIT) ELECTRODE ARRAY.
P950008|S004|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|30-Day Notice||N|12/06/2001|01/03/2002|||OK30|MODIFICATION OF TESTING METHODOLOGY FOR LOW MOLECULAR WEIGHT SILOXANES DETERMINATION IN SILIKON 1000.
P990017|S030|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE/AORTOILIAC ENDOGRAFT SYSTEM|MIH|CV|Panel Track|Change Design/Components/Specifications/Material|N|12/19/2001|04/24/2002|02M-0298|07/02/2002|APPR|APPROVAL FOR THE ANCURE AORTOILIAC SYSTEM.  THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS IN PATIENTS WHOSE ANATOMY DOES NOT ALLOW THE USE OF A TUBE OR BIFURCATED DEVICE.
P000057|S001|INTEGRA LIFESCIENCES CORPORATION|8900 CAMERON ROAD||AUSTIN|TX|78754||Finger semi-constrained pyrolytic carbon uncemented prosthesis|ASCENSION MCP|NEG|OR|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|12/19/2001|02/08/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950037|S023|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|PHILOS DR-T PULSE GENERATOR|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2002|04/02/2002|||APPR|APPROVAL FOR CHANGES TO THE PULSE GENERATOR TO ALLOW TRANSMISSION OF DIAGNOSTIC INFORMATION, AND FOR CHANGES TO THE PROGRAMMER SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS DR-T PULSE GENERATOR AND B-K00.T.U PROGRAMMER SOFTWARE, AND HAS THE SAME INDICATIONS AS THE CURRENTLY MARKETED PHILOS DR.  SPECIFICALLY:  1) RATE ADAPTIVE PACING WITH PHILOS DR-T PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.  2) INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E., BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD-DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME.  3) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
P930031|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS|MIR|CV|Normal 180 Day Track|Express GMP Supplement|N|12/20/2001|01/10/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND AND AN ALTERNATE STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND.
P940019|S009|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|12/20/2001|01/10/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND AND AN ALTERNATE STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND.
P980033|S001|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|12/20/2001|01/10/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND AND AN ALTERNATE STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND.
P000043|S001|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2001|05/23/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT MANUFACTURING AND RESEARCH, INC., TUCSON, ARIZONA.  THE RX-200 APPLICATOR WILL BE MANUFACTURED AT THIS FACILITY.
P000043|S002|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 (TM) BPH THERMOTHERAPY SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2001|01/11/2002|||APPR|APPROVAL FOR DESIGN CHANGES TO THE RX-200 APPLICATOR OF THE TMX-2000 BPH THERMOTHERAPY SYSTEM.
P900043|S031|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track||N|12/21/2001|05/10/2002|||APPR|APPROVAL FOR THE HEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<= 30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM; AND  2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM.  THE 2.25 MM, 2.5 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
P960043|S036|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|THE CLOSER/ CLOSER S THUMBCAP ASSEMBLY|MGB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2001|02/05/2002|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE THUMBCAP ASSEMBLY.
P990035|S005|BEAM-MED LTD|8 HALAPID STR.||PETACH TIKVA||49170||Bone sonometer|OMNISENSE 7000S ULTRASOUND BONE SONOMETER|MUA|RA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2001|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZICON LTD., PETAH-TIKVA, ISRAEL.
P960036|S005|IOLTECH, S.A.|64 SCHOOSETT STREET||PENBROKE|MA|02359|1882|intraocular lens|MEMORYLENS MODEL U940A UV-ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL|HQL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2001|05/23/2002|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESSES FOR THE MEMORYLENS IOL.
P790018|S042|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|HALL EASY-FIT PROSTHETIC HEART VALVE|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/2001|01/11/2002|||APPR|APPROVAL TO INCLUDE ONE ADDITIONAL PRECAUTION STATEMENT TO THE INSTRUCTIONS FOR USE.
P960025|S009|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE SYSTEM|MCV|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2001|02/04/2002|||APPR|APPROVAL FOR THE USE OF THE MONARCH SPINAL SYSTEM TO BE USED WITH THE LUMBAR I/F CAGE SYSTEM.
P810046|S211|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/2001|02/22/2002|||APPR|APPROVAL FOR A SINGLE PROCESS CHANGE CONCERNING THE TEMPERATURE FOR THE ACCELERATING AGING PROTOCOL FOR THE SHELF-LIFE TESTING OF THE POWERSAIL AND HIGHSAIL CORONARY DILATATION CATHETERS.
P970035|S033|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2001|04/24/2002|||APPR|APPROVAL FOR THE ADDITION OF AN OPTIONAL MECHANICAL FIXATION STEP TO THE STENT SECUREMENT PROCESS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM AND IS INDICATED FOR THE IMPROVEMENT OF CORONARY LUMINAL DIAMETER.
P950018|S008|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2001|07/29/2002|||APPR|APPROVAL FOR ADDING BLISTER PACKAGING TO THE VIAL PRODUCT THAT IS THEN SUBJECTED TO A STEAM STERILIZATION PROCESS IN ORDER TO PROVIDE A FINISHED PRODUCT VIAL WITH A STERILE EXTERIOR.  ALSO, APPROVAL OF A 10 ML VIAL FOR THE 7 ML FILL PRODUCT TO ALLOW STERILIZATION HEADSPACE.
P900067|S003|AIR LIQUIDE|6141 EASTON ROAD|P.O. BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY|LPO|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/2001|01/29/2002|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO IMPROVE THE PATIENT'S AND DOCTOR'S KNOWLEDGE REGARDING THE HAZARDS OF USING NITROUS OXIDE FOR A SUBSEQUENT SURGICAL PROCEDURE WHEN GAS IS STILL PRESENT IN THE EYE.
P970020|S040|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS|MAF|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/2001|08/06/2002|04M-0024|01/21/2004|APPR|APPROVAL FOR THE ADDITION OF A NEW INDICATION.  THE ACS MULTI-LINK DEVICES ARE INDICATED FOR THE FOLLOWING (SEE INDIVIDUALIZATION OF TREATMENT):  1) IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS LENGTH <= 25 MM WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM.   2) IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS LENGTH <= 35 MM WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM.  3) RESTORING CORONARY FLOW IN PATIENTS EXPERIENCING ACUTE MYOCARDIAL INFARCTION, AS CONFIRMED BY ST SEGMENT ELEVATION OR ANGIOGRAPHIC FINDINGS, WHO PRESENT WITHIN 12 HOURS OF SYMPTOM ONSET WITH NATIVE CORONARY ARTERY LESIONS OF LENGTH <= 35 MM WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM TO 4.0 MM.  4) TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS LENGTH <= 35 MM WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM TO 4.0 MM.  LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P930014|S009|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF NATURAL SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL SB30AL)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/2001|06/24/2003|||APPR|APPROVAL FOR THE ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS (MODEL SB30AL).  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICA-TION ARE PERFORMED.  THESE LENSES ARE INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
P990030|S003|ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Agent, absorbable hemostatic, collagen based|COSTASIS/DYNASTAT SURGICAL HEMOSTATS|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/2001|03/14/2002|||APPR|APPROVAL OF THE UROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COSTASIS/DYNASTAT SURGICAL HEMOSTAT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO THE HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P990053|S005|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/2001|06/28/2002|||APPR|APPROVAL FOR SOFTWARE UPGRADE.
P950037|S024|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|SOLOX VDD PACING LEAD|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/2001|04/23/2003|||APPR|APPROVAL FOR THE SOLOX VDD PACING LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOLOX VDD PACING LEAD AND IS INDICATED AS FOLLOWS:  THE SOLOX LEAD IS INDICATED FOR USE AS PART OF A SYSTEM ONLY.  THE SYSTEM INCLUDES ANY OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS AND THE SOLOX VDD LEAD.  THEREFORE, THE INDICATIONS FOR THE SOLOX VDD LEAD ARE IDENTICAL TO THE INDICATIONS FOR USE OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS.  BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS ARE PRIMARILY INTENDED TO PROVIDE VDD PACING FOR PATIENTS WITH A HEALTHY SINUS NODE.  THESE PULSE GENERATORS ARE SPECIFICALLY INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES ARE PRESENT.  THIS INCLUDES THE PRESENCE OF COMPLETE A-V BLOCK WHEN:  1) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT AND  2) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED.  ADDITIONAL INDICATIONS INCLUDE: NORMAL SINUS RHYTHM AND NORMAL A-V CONDUCTIONS IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT.  NOTE: PATIENTS WITH KNOWN PAROXYSMAL ATRIAL FIBRILLATION/FLUTTER MAY REQUIRE FURTHER EVALUATION PRIOR TO IMPLANTATION.  OTHER PACING MODES ARE INCORPORATE DIN THE PULSE GENERATOR (VDDR, VVI, VVIR, VOO, VOOR, VDT, VVT, AND VDI) IN ORDER TO PROVIDE CLINICAL  FLEXIBILITY TO MANAGE CHANGES IN THE PATIENT'S CONDITION, FOR DIAGNOSTIC PURPOSES, OR IN THE EVENT THAT VDD PACING BECOMES INAPPROPRIATE.
P900043|S032|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT WITH HEPACOAT ON RAPTORAIL(RX)/RAPTOR(OTW) STENT DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/04/2002|01/31/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING, ADDING SEVERAL WARNINGS FOR OPENING THE PACKAGING.
P990054|S003|Boston Scientific Corp.|2710 ORCHARD PKWY.||SAN JOSE|CA|95113||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Express GMP Supplement|N|12/26/2001|01/08/2002|||APPR|APPROVAL FOR THE ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA.
P980003|S004|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Express GMP Supplement|N|12/26/2001|01/08/2002|||APPR|APPROVAL FOR THE ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA.
P990001|S011|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2002|02/13/2002|||APPR|APPROVAL FOR PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM PULSE GENERATORS.
P000009|S003|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2002|03/11/2002|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE CARTRIDGE  I-KDR.0.U, EMBEDDED SOFTWARE CHANGES AND MINOR HARDWARE CHANGES TO THE TACHOS DR ICD.
P970061|S014|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|SCIMEN RADIUS STENT WITH MONORAIL DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/08/2002|02/15/2002|||APPR|APPROVAL FOR MINOR LABELING CHANGES TO THE PACKAGE LABELING AND THE "DIRECTIONS FOR USE" MANUAL FOR THE RADIUS CORONARY STENT SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCIMED RADIUS STENT WITH MONORAIL DELIVERY SYSTEM AND IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY AND SAPHENOUS VEIN BYPASS GRAFT LESIONS (LENGTH < 30 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.75 TO 4.25 MM AND IS INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER.
P940019|S010|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2002|02/12/2002|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE AND THE PACKAGE LABELING.
P930031|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2002|02/12/2002|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE AND THE PACKAGE LABELING.
P910065|S003|TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|AIA-PACK PA|LTJ|IM|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2002|09/09/2002|||APPR|APPROVAL TO CHANGE THE LOCATION OF THE MANUFACTURING FACILITY OF THE ASCITES FLUID USED IN THE PREPARATION OF THE MONOCLONAL ANTIBODIES FROM THE TOSOH TOKYO RESEARCH CENTER IN AYASE, JAPAN TO NISSEIKEN, CO. LTD. IN TOKYO, JAPAN.
P000049|S001|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD|MLV|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|01/10/2002|04/19/2002|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD.
P970003|S037|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/10/2002|02/22/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MATERIAL OF THE SEPTUM USED ON THE MODEL 101 NCP PULSE GENERATOR.
P000049|S002|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL|MLV|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|01/11/2002|04/19/2002|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD.
P000008|S001|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|BIOENTERICS LAP-BAND|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/2002|08/26/2002|||APPR|APPROVAL FOR A MANUFACTURING METHOD CHANGE WITH A CORRESPONDING CHANGE IN MATERIAL.
P960043|S037|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2002|02/13/2002|||OK30|RECLASSIFICATION OF THE CLEANROOM FROM CLASS 10,000 OF THE FEDERAL STANDARD 209E TO CLASS 8 OF ISO 14644-1 USED IN THE MANUFACTURE OF THE PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS.
P900066|S005|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY|LPO|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/2001|01/29/2002|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO IMPROVE THE PATIENT'S AND DOCTOR'S KNOWLEDGE REGARDING THE HAZARDS OF USING NITROUS OXIDE FOR A SUBSEQUENT SURGICAL PROCEDURE WHEN GAS IS STILL PRESENT IN THE EYE.
P990033|S003|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15/PEPGEN P-15 FLOW|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2002|01/25/2002|||OK30|CHANGE IN MANUFACTURER/VENDOR FOR THE P-15 PEPTIDE.
P990037|S009|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/15/2002|04/03/2002|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE DUETT SEALING DEVICE AND DIAGNOSTIC DUETT SEALING DEVICE.  SPECIFICALLY, A RELIEF VALVE COMPONENT WILL REPLACE THE PILOT BALLOON ASSEMBLY ON BOTH DEVICES.
P010016|S002|FORTICELL BIOSCIENCE|3960 BROADWAY||NEW YORK|NY|10032||Dressing, wound and burn, interactive|ORCEL BILAYERED CELLULAR MATRIX|MGR|SU|Real-Time Process|Other Report|N|12/27/2001|01/17/2002|||APPR|APPROVAL FOR USE OF CELL LINE FS-183 IN THE COMMERCIAL MANUFACTURE OF ORCEL BILAYERED CELLULAR MATRIX.
P930036|S002|SIEMENS HEALTHCARE DIAGNOSTICS INC.|333 CONEY  STREET||EAST WALPOLE|MA|02032||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACS:180/ADVIA CENTAUR AFP IMMUNOASSAY|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2002|02/12/2002|||APPR|APPROVAL FOR THE USE OF PURIFIED MOUSE AFP CLONE ML355-7G12.2A6.5C4 ANTIBODY IN THE PRODUCTION OF THE BAYER ACS:180 AND ADVIA CENTAUR AFP SOLID PHASE.
P990016|S002|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||Bone sonometer|MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM|MUA|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/16/2002|03/28/2002|||APPR|APPROVAL OF THE CUBACLINICAL DATA CONTROLLER (DATA CONTROLLER).  THE DATA CONTROLLER IS A HAND-HELD CONTROL DEVICE THAT ENABLES THE USER TO OPERATE THE CUBACLINICAL WITHOUT THE COMPUTER AND THE SOFTWARE FOR DATA ANALYSIS.  THE MODIFICATIONS TO THE BONE SONOMETER CONSIST OF THE INTEGRATION OF THE DATA CONTROLLER AND ASSOCIATED SOFTWARE, SIMPLE REPLACEMENT OF THE CUBACLINICAL SERIAL CONNECTOR, AND DATA CONTROLLER OPERATING INSTRUCTIONS.  THE RESULTS ARE DISPLAYED ON AN LCD SCREEN DISPLAY AND THE PRINTOUT SHOWS A GRAPHICAL DISPLAY OF PATIENT DATA.
P990026|S012|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2002|02/04/2002|||OK30|CHANGE IN THE SAMPLING PLAN FOR INCOMING AND IN-PROCESS COMPONENTS AND FINISHED PRODUCTS.
P990038|S002|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/2002|03/07/2002|||APPR|APPROVAL FOR INCLUSION OF THE INSTRUMENT REPRODUCIBILITY STUDY IN THE PACKAGE INSERT.
P970004|S020|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM FOR URINARY CONTROL|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/2002|02/04/2002|||APPR|APPROVAL FOR  1) THE ADDITION OF TEST STIMULATION CABLES TO THE EXISTING MODEL 3057 TEST STIMULATION LEAD PACKAGE AND THE MODEL 3065U TEST STIMULATION LEAD KIT, AND  2) ASSOCIATED LABELING REVISIONS TO THE MODEL 3065U INTERSTIM TEST STIMULATION LEAD KIT TECHNICAL MANUAL AND THE INTERSTIM TEST STIMULATION COMPONENTS INSTRUCTIONS FOR USE.
P960042|S008|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH|MFA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/17/2002|05/02/2002|||APPR|APPROVAL FOR A MODIFICATION TO THE 12F AND 14F LASER SHEATH KITS (MODELS 500-001 AND 500-012).
P980035|S018|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|KAPPA 900/800 IMPLANTABLE PULSE GENERATOR FAMILY SERIES|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2002|02/07/2002|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA FROM CLASS 10,000 TO A MINIMUM OF CLASS 100,000.
P970004|S021|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/17/2002|02/15/2002|||APPR|APPROVAL FOR THE REVISED INDICATION: "INTERSTIM THERAPY FOR URINARY CONTROL IS INDICATED FOR THE TREATMENT OF URINARY RETENTION AND THE SYMPTOMS OF OVERACTIVE BLADDER, INCLUDING URINARY URGE INCONTINENCE AND SIGNIFICANT SYMPTOMS OF URGENCY-FREQUENCY ALONE OR IN COMBINATION, IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS".
P990045|S002|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/18/2002|03/07/2002|||APPR|APPROVAL FOR INCLUSION OF THE INSTRUMENT REPRODUCIBILITY STUDY IN THE PACKAGE INSERT.
P980023|S006|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|BELOS VR ICD SYSTEM|DTA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2002|03/11/2002|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE CARTRIDGE  I-K01.0.A/4, MINOR EMBEDDED SOFTWARE CHANGES, MINOR HARDWARE CHANGES, AND A CORRECTION TO THE "USE BEFORE" DATE.
P950022|S014|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA SERIES 1500 DEFIBRILLATION LEAD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/31/2002|03/11/2002|||APPR|APPROVAL FOR NEW DEFIBRILLATION LEAD SYSTEMS AND ACCESSORIES.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIAT SERIES 1500 (MODELS 1570, 1571, 1580 AND 1581) DEFIBRILLATION LEAD SYSTEM AND ACCESSORIES (S-65-S, S-65-F, S-65-X, TX-070).  THESE DEVICES ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS (REFER TO THE APPLICABLE DEFIBRILLATOR MANUAL FOR SYSTEM INDICATIONS.).  THEY PROVIDE PACING AND SENSING AND DELIVER CARDIOVERSION/DEFIBRILLATION THERAPY TO THE HEART.
P990041|S001|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-EBK PLUS|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/2002|03/07/2002|||APPR|APPROVAL FOR REPRODUCIBILITY STUDIES USING SERUM IN THE PACKAGE INSERT.
P990044|S001|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/2002|03/06/2002|||APPR|APPROVAL FOR INCLUSION OF REPRODUCIBILITY STUDIES IN THE PACKAGE INSERT.
P010013|S001|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/2002|05/23/2002|||APPR|APPROVAL FOR A REVISED PATIENT BROCHURE.
P980023|S007|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|KENTROX RV LEAD SYSTEMS|DTA|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/2002|02/21/2002|||APPR|APPROVAL FOR A NAME CHANGE FOR THE TEROX RV 65 AND TEROX RV 75 LEADS.  THE DEVICE WILL NOW BE MARKETED UNDER THE TRADE NAME KENTROX RV 65 (MODEL 332 232) AND KENTROX RV 75 (MODEL 332 231) AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).
P860019|S178|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK MONORAIL PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2002|02/21/2002|||OK30|ALTERNATIVE MANUFACTURING METHOD FOR JOINING THE POLYMER MIDSHAFT TO THE HYPOTUBE MIDSHAFT ON THE MAVERICK MONORAIL PRODUCT LINE.
P890023|S013|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/18/2002|03/11/2002|||APPR|APPROVAL FOR BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS/ 6 NIGHTS).  THE SPONSOR ALSO REQUESTED APPROVAL OF THE SUBJECT DEVICES TO INCLUDE A STATEMENT THAT THE UV ABSORBING CONTACT LENSES HELP TO PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION:  THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES WHICH MANIFEST MYOPIA (NEARSIGHTEDNESS), HYPEROPIA (FARSIGHTEDNESS) AND ASTIGMATIC CORRECTION LOWER THAN -2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR.  FOR EXTENDED WEAR, THE LENS MAY BE PRESCRIBED FOR UP TO 7 DAYS/6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION; OR FOR DISPOSABLE WEAR AS DIRECTED BY THE EYE CARE PRACTITIONER.  THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT.  WHEN PRESCRIBED FOR SCHEDULED REPLACEMENT THE LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) OR HYDROGEN PEROXIDE DISINFECTING SYSTEM.  THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
P990043|S002|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/2002|03/11/2002|||APPR|APPROVAL FOR INCLUSION OF THE INSTRUMENT REPRODUCIBILITY STUDY IN THE PACKAGE INSERT.
P990017|S031|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Express GMP Supplement|N|01/22/2002|02/14/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P000008|S002|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2002|08/01/2002|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE LAP-BAND ADUSTABLE GASTRIC BANDING (LAGB) SYSTEM:  1) INTRODUCTION OF A REDESIGNED ACCESS PORT (ACCESS PORT II);  2) REPLACE THE CALIBRATION TUBE (CALIBRATION TUBE I) CURRENTLY PROVIDED IN THE LAGB) SYSTEM WITH A REDESIGNED CALIBRATION TUBE (CALIBRATION TUBE II); AND  3) INTRODUCTION OF 2" ACCESS PORT NEEDLES TO BE SOLD AS AN ACCESSORY ITEM.  IN ADDITION TO BEING SOLD AS COMPONENTS OF THE LAGB SYSTEM, BOTH THE ACCESS PORT II AND THE CALIBRATION TUBE II WILL BE SOLD AS SEPARATE ACCESSORIES.
P980035|S019|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 900/800 PACEMAKER SERIES|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/2002|08/07/2003|||APPR|APPROVAL FOR EXPANDED PROGRAMMABLE UPPER TRACKING RATE OPTIONS AND POST MODE SWITCH OVERDRIVE PACING.
P990042|S002|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/24/2002|03/05/2002|||APPR|APPROVAL FOR INCLUSION OF PLASMA REPRODUCIBILITY STUDIES IN THE PACKAGE INSERT.
P980052|S001|TMJ CONCEPTS|2233 KNOLL DRIVE||VENTURA|CA|93003||Joint, temporomandibular, implant|TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM|LZD|DE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2002|03/01/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TMJ CONCEPTS, VENTURA, CALIFORNIA.
P000039|S001|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|THE AMPLATZER SEPTAL OCCLUDER DEVICE|MAE|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|01/28/2002|03/27/2002|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE.
P910071|S006|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL SYRINGE|LWL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/29/2002|12/23/2002|||APPR|APPROVAL FOR THE FOLLOWING CHANGES FOR ADATO SIL-OL 5000 SILICONE OIL:  1) ADDITION OF  A NEW PRIMARY CONTAINER CLOSURE SYSTEM (GLASS SYRINGE);  2) PHARM PUR GMBH, AUGSBURG, GERMANY, AS THE SITE FOR FILLING, STERILIZATION, LABELING AND PACKAGING FOR ADATO SIL-OL 5000 SILICONE OIL PACKAGED IN A SYRINGE;  3) PARAMETRIC RELEASE OF THE ADATO SIL-OL 5000 SILICONE OIL SYRINGE PACKAGED PRODUCT IN LIEU OF END PRODUCT STERILITY TESTING; AND  4)  DOUBLE POUCH PACKAGING FOR ADATO SIL-OL 5000 SILICONE OIL SYRINGE.
P860022|S054|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens,contact(rigid gas permeable)-extended wear|BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS|MWL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/2002|05/06/2002|||APPR|APPROVAL FOR AN ASPHERIC DESIGN FOR EXTENDED WEAR AND LABELING CHANGES FOR THE DEVICE.  REQUESTED LABELING CHANGES INCLUDE:  1) CHANGE FROM THE TITLE "PATIENT INSTRUCTIONS" TO "PATIENT CARE GUIDE".  2) UPDATE THE PRESCRIPTION CAUTION STATEMENT.  3) MODIFY THE PRODUCT DESCRIPTION SECTION OF THE PACKAGE INSERT AND PROFESSIONAL FITTING AND INFORMATION GUIDE AS FOLLOWS: A) ADD THE DESCRIPTIONS FOR BOTH THE ASPHERIC DESIGN (EXTENDED AND DAILY WEAR) AND THE PREVIOUSLY APPROVED BIFOCAL LENS (DAILY WEAR ONLY) AND SPECIFY DAILY WEAR FOR THE TORIC AND BIFOCAL DESIGNS; B) REMOVE FROM THESE PRODUCT DESCRIPTION SECTIONS THE PHRASE "WITHOUT UV" BECAUSE THIS OPTION IS NO LONGER AVAILABLE; AND C) CHANGE THE COLOR NAME OF THE BLUE LENS MATERIAL FROM "DARK BLUE" TO "ELECTRIC BLUE".  4)  CORRECT THE MANUFACTURER'S ADDRESS.  5) UPDATE THE WORDING OF THE UV WARNING AND CLARIFY THE EXTENDED WEAR INDICATION AS IN THE INDICATION STATED BELOW."THE BOSTON EQUALENS (ITAFLUOROFOCON A) RGP CONTACT LENS IS INDICATED FOR DAILY OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THE LENS IS INDICATED FOR EXTENDED WEAR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00D TO +12.00D.  THE LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA, ASTIGMATISM AND PRESBYOPIA) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY."
P990027|S005|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217A EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Express GMP Supplement|N|01/31/2002|03/13/2002|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT BAUSCH & LOMB TECHNOLAS GMBH, FELDKIRCHEN, GERMANY.
P800012|S008|OSMED, INC.|325 LAKE AVE. SOUTH - SUITE|#608|DULUTH|MN|55802||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|DRILAC GRANULES|LPG|DE|Normal 180 Day Track|Express GMP Supplement|N|01/31/2002|03/05/2002|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT KENSEY NASH CORPORATION, EXTON, PENNSYLVANIA.  THE GRANULATION AND SYRINGE CUTTING PROCESSES WILL BE CONDUCTED AT THIS FACILITY.
P990071|S002|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR|DRF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/29/2001|02/15/2002|||APPR|APPROVAL FOR  1) ADAPTER CABLES (MODELS D-1170-27-001, D-1170-28-001, AND D-1170-29-001) THAT CONNECT THE STOCKERT 70 RF GENERATOR CABLE TO COMPATIBLE CATHETERS AND  2) A NEW INDICATIONS FOR USE FOR THE STOCKERT 70 RF GENERATOR.  THE ADAPTER CABLES WILL BE MARKETED UNDER THE TRADE NAME STOCKERT 70 RF GENERATOR CABLE   ADAPTERS FOR CARDIAC ABLATION.  BOTH THE STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION AND STOCKERT 70 RF GENERATOR ARE INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES.
P980007|S002|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ABBOTT ARCHITECT FREE PSA|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/2002|02/05/2004|||APPR|APPROVAL FOR THE ARCHITECT FREE PSA ASSAY.
P880003|S083|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|RAPTORAIL  PTCA DILATATION CATHETER (RX)|LOX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2002|02/12/2002|||APPR|APPROVAL FOR CHANGES TO THE QUALITY PLAN:  1) THE ADDITION OF A 100% VISUAL MARKER BAND PLACEMENT VERIFICATION;  2) THE ADDITION OF A QC AUDIT FOR MARKER BAND PLACEMENT VERIFICATION; AND  3) THE ADDITION OF A QC FUNCTIONAL TEST FOR INFLATION/DEFLATION TIME VERIFICATION.
P900043|S033|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT ON RAPTORRAIL/WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2002|03/05/2002|||APPR|APPROVAL FOR TWO CHANGES TO THE QUALITY PLAN FOR THE PRODUCTS.
P000011|S006|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|BIODIVYSIO SV OTW PHOSPHORYLCHOLINE COATED STENT DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track||N|02/01/2002|07/26/2002|||APPR|APPROVAL FOR THE ADDITION OF THE 7 MM STENT LENGTH (IN ALL DIAMETERS, 2.0, 2.25 AND 2.5 MM) AND 2.25 MM DIAMETER BIODIVYSIO SV OTW PRODUCT TO PREVIOUSLY APPROVED STENT LENGTHS OF 10, 15 AND 18 MM (SUPPLEMENT 3).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO SV OTW AND IS INDICATED FOR:  "IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS EXPERIENCING ABRUPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH REFERENCE VESSEL DIAMETER RANGING FROM >=2.0 MM TO <=2.75 MM BY VISUAL ESTIMATE.  LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS IMPLANT IS UNKNOWN AT PRESENT.
P990052|S007|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR|MPV|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2002|04/17/2002|||APPR|APPROVAL FOR THE ADDITION OF THE DIRECT DRIVE DEMONSTRATOR TO THE VIBRANT SOUNDBRIDGE SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR.  THE INDICATIONS FOR USE FOR THE DEVICE HAVE NOT CHANGED.
P950032|S029|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2002|03/14/2002|||APPR|APPROVAL OF A NEW CELL STRAIN FOR THE PRODUCTION OF APLIGRAF (I.E., HEP990), AND THE REPLACEMENT OF FLOW CYTOMETRIC ALLOGENICITY AND IMMUNO-PHENOTYPING ASSAYS USED IN CELL STRAIN CHARACTERIZATION WITH A SIMILAR CELL PURITY ASSAY.
P900043|S034|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY BALLOON-EXPANDABLE STENT WITH RAPTOR OVER THE WIRE DELIVERY SYSTEM/BX VELOCITY WITH HEPACOAT ON RAPTOR STENT|MAF|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2002|03/05/2002|||APPR|APPROVAL FOR A CHANGE TO THE QUALITY PLAN FOR THE PRODUCTS.
P970008|S019|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/04/2002|08/01/2002|||APPR|APPROVAL FOR MODIFICATION OF THE TARGIS SYSTEM LABELING REGARDING THE TREATMENT OF PATIENTS WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS).
P970058|S012|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER M1000|MYN|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/05/2002|02/11/2002|||APPR|APPROVAL FOR A CHANGE TO THE NEW EFFICACY CLAIM IN PMA SUPPLEMENT 7 (VERSION 2.2 SOFTWARE).  THE CHANGE IS FROM: "FOR EVERY 100,000 CANCERS CURRENTLY DETECTED BY SCREENING MAMMOGRAPHY, THE USE OF THE IMAGECHECKER COULD RESULT IN EARLY DETECTION OF AN ADDITIONAL 30,500 BREAST CANCERS."  TO: "USE OF THE IMAGECHECKER COULD RESULT IN EARLIER DETECTION OF UP TO 23.4% (95% CI, 19.4% - 27.4%) OF THE CANCERS CURRENTLY DETECTED WITH SCREENING MAMMOGRAPHY IN THOSE WOMEN WHO HAD A PRIOR SCREENING MAMMOGRAM 9-24 MONTHS EARLIER."
P920004|S016|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL VHD & ES DEVICES|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/05/2002|03/07/2002|||APPR|APPROVAL FOR A CHANGE IN THE INSTRUCTIONS FOR USE.  SPECIFICALLY, TO REMOVE THE OCCLUSIVE PRESSURE WHILE MAINTAINING ADHESIVE (DEVICE) PLUNGER PRESSURE AND POSITIONS AFTER THE FIRST COLLAGEN CARTRIDGE HAS BEEN DEPLOYED.
P900056|S068|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES GOLD PLATING PROCESS/FLOPPY GOLD|MCX|CV|Normal 180 Day Track|Express GMP Supplement|N|02/05/2002|02/21/2002|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORPORATION, MIAMI TECHNOLOGY CENTER, MIAMI, FLORIDA.  THE FLOPPY GOLD GUIDE WIRE GOLD PLATING PROCESS WILL BE PERFORMED AT THIS FACILITY.
P990050|S005|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD,SUITE|11|SAN DIEGO|CA|92121||ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)|WAVSTAT OPTICAL BIOPSY SYSTEM|MOA|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/2002|08/06/2002|||APPR|APPROVAL FOR THE WAVSTAT OPTICAL BIOPSY SYSTEM (OBS) TO BE EXTENDED TO INCLUDE THE WAVSTAT OPTICAL BIOPSY SYSTEM MODEL III CONSOLE.
P010030|S001|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WCD 3000 SYSTEM|MVK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/2002|10/09/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE WCD MONITOR (P010030/S001) AND ELECTRODE BELT/CHEST GARMENT SYSTEM (P010030/S003).  THE SYSTEM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3000 SYSTEM AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND EITHER ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P990066|S011|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2002|02/22/2002|||OK30|ADDITION OF A SUPPLIER FOR THE GANTRY ELECTRONIC BOARDS OF THE SENOGRAPHE 2000D FFDM SYSTEM.  THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
P860019|S179|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK 2 MONORAIL PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/2002|11/20/2002|||APPR|APPROVAL FOR THE MAVERICK2 MONORAIL PTCA CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAVERICK2 MONORAIL PTCA CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE MAVERICK2 BALLOON CATHETER (2.25 - 4.00 MM) IS ALSO INDICATED FOR THE POST DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P970003|S038|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2002|03/28/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 250 PROGRAMMING SOFTWARE, RESULTING IN NEW VERSIONS 4.6 AND 6.1.
P950019|S012|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY TFC DEVICE/RAY TFC UNITE DEVICE|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2002|04/02/2002|||APPR|APPROVAL FOR ADDITIONAL INSTRUMENTS FOR THE ALIF-OPEN SURGICAL TECHNIQUE FOR THE RAY TFC AND RAY TFC UNITE DEVICES AND REVISED LABELING.
P920004|S017|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL 4-5 FRENCH SYSTEM|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/14/2002|06/11/2002|||APPR|APPROVAL TO MARKET A SMALLER VERSION OF THE VASOSEAL VHD DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VASOSEAL 4-5 FRENCH SYSTEM AND IS INDICATED FOR "USE IN SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES USING A 4 OR 5 FRENCH PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH.  THE VASOSEAL 4-5 FRENCH SYSTEM REDUCES TIME TO HEMOSTASIS, AMBULATION AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES."
P980035|S020|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 900/800 SERIES PLUSE GENERATORS|DXY|CV|Normal 180 Day Track|Express GMP Supplement|N|02/14/2002|02/26/2002|||APPR|APPROVAL FOR ALTERNATE FACILITIES FOR THE MANUFACTURING, PACKAGING AND STERILIZATION OF THE MEDTRONIC KAPPA 900/800 SERIES PULSE GENERATOR PRODUCTS: MEDTRONIC BV, KERKRADE, THE NETHERLANDS AND MEDTRONIC EUROPE S.A., TOLOCHANEZ, SWITZERLAND.
P970020|S041|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX PIXEL/OTW PIXEL CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track||N|02/15/2002|06/28/2002|||APPR|APPROVAL FOR INCLUSION OF SIX-MONTH TRIAL DATA IN THE INSTRUCTIONS FOR USE BOOKLET FOR THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS.
N18286|S013|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2002|03/20/2002|||OK30|CHANGE TO THE BACTERIAL ENDOTOXIN TEST METHOD FOR GELFOAM ABSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM IN ORDER TO COMPLY WITH THE RECENTLY HARMONIZED USP, EP AND JP COMPENDIA FOR BACTERIAL ENDOTOXIN ASSAY.
P970058|S013|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER M1000 SYSTEM|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/19/2002|04/24/2002|||APPR|APPROVAL FOR THE ADDITION OF "SMARTVIEW", A FEATURE THAT ENABLES A USER TO SEE WITH MORE DETAIL THE REGION UNDERLYING A MARKER PLACED ON A MAMMOGRAM DISPLAY.
P900043|S035|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|HEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/2002|08/02/2002|||APPR|APPROVAL FOR A MODIFICATION OF THE INDICATIONS FOR THE HEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<=30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM INVOLVING DIRECT STENTING OR PREDILATATION; AND  2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.0 MM.  THE 2.25 MM, 2.5 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
P920031|S002|DADE BEHRING, INC.|PO BOX 6101||NEWARK|DE|19714|6101|CYCLOSPORINE|COBAS INTEGRA CYCLOSPORINE|MKW|TX|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/2002|02/26/2002|||APPR|APPROVAL TO EXPAND THE USE OF THE COBAS INTEGRA CYCLOSPORING REAGENT SYSTEM TO THE COBAS INTEGRA 400 AND COBAS INTEGRA 800 ANALYZERS.
N18033|S037|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER|LPM|OP|Special (Immediate Track)||N|02/19/2002|03/18/2002|||APPR|APPROVAL FOR LABELING CHANGES FOR THE DEVICE.  THE CHANGES WILL ADD ADDITIONAL STATEMENTS TO THE "PRECAUTIONS" SECTION OF THE PACKAGE INSERT TO ALERT BOTH DOCTORS AND PATIENTS ABOUT VISUAL SYMPTOMS AND/OR PERIPHERAL AWARENESS THAT PATIENTS MIGHT EXPERIENCE DUE TO A REDUCTION IN THE VISIBLE LIGHT TRANSMISSION.  THE FOLLOWING ADDITIONAL PRECAUTION STATEMENT WILL BE ADDED TO THE PACKAGE INSERT:  "DUE TO REDUCTION IN LIGHT TRANSMITTANCE WITH COSMETICALLY TINTED LENSES, SOME PATIENTS MAY EXPERIENCE VISUAL SYMPTOMS WHILE WEARING ACUVUE 2 COLOURS BRAND.  IN ADDITION, SOME PATIENTS MAY EXPERIENCE PERIPHERAL AWARENESS DUE TO THE OPAQUE IRIS PATTERN."  THE FOLLOWING ADDITIONAL PRECAUTION STATEMENT WILL BE ADDED TO THE PATIENT INSTRUCTION GUIDES:  "WHEN WEARING LENSES THAT ALTER YOUR EYE COLOR, YOU MAY NOTICE TEMPORARY DIFFERENCES IN YOUR VISION DUE TO A CHANGE IN THE AMOUNT OF LIGHT THAT ENTERS YOUR EYES.  IF THESE DIFFERENCES IN VISION PERSIST WHEN WEARING ACUVUE 2 COLOURS BRAND, IT IS IMPORTANT THAT YOU CONSULT YOUR EYE CARE PROFESSIONAL."
P930038|S033|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2002|03/20/2002|||APPR|APPROVAL FOR 3 CHANGES TO THE INSTRUCTIONS FOR USE FOR THE ANGIO-SEAL DEVICE FAMILY.
P890047|S014|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/2002|03/25/2002|||APPR|APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO ENHANCE THE SAFE USE OF THE DEVICE.
P840064|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/2002|03/25/2002|||APPR|APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE PROVISC PORTION OF THE DUOVISC INSERT TO ENHANCE THE SAFE USE OF THE DEVICE.  THE PROVISC SYRINGE ASSEMBLY INSTRUCTIONS WILL STANDARDIZE INSTRUCTIONS WITHIN THE DUOVISC INSERT.
P000052|S005|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/2002|08/22/2002|||APPR|APPROVAL FOR HARDWARE AND SOFTWARE CHANGES FOR THE GALILEO SOURCE DELIVERY UNIT, I.E., AN ALTERNATE PRIMARY CIRCUIT BOARD (AMPRO BOARD), LCD DISPLAY AND ASSOCIATED SOFTWARE.  THESE CHANGES ARE APPLICABLE TO THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM, WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, THE 27 MM 32P SOURCE WIRE AND THE 27 MM GALILEO CENTERING CATHETER.
P970042|S002|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotripter, shockwave (for treating gallbladder stones)|MEDSTONE STS LITHOTRIPTER|NCV|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2002|08/20/2002|||APPR|APPROVAL FOR  1) THE USE OF TWO GENERIC URSODIOLS, ONE MANUFACTURED BY AMIDE PHARMACEUTICAL AND ONE BY TEVA PHARMACEUTICAL, IN ADDITION TO ACTIGALL;  2) A CHANGE IN THE POST-APPROVAL STUDY'S MEDICAL MONITOR TO JOAN L. DRUCKER M.D., R.S.I.; AND  3) SEVERAL MINOR CLARIFICATIONS, CORRECTIONS AND EDITORIAL CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, MEDSTONE STS LITHOTRIPTER, AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (BETWEEN 4 AND 20 MM IN MAXIMUM DIAMETER) IN ADULTS PATIENTS FOR WHOM SURGICAL REMOVAL OF THE GALLBLADDER IS MEDICALLY CONTRAINDICATED AND IN SYMPTOMATIC HIGH-RISK PATIENTS WHO HAVE ACTIVELY REFUSED SURGERY.  COMBINATION THERAPY CONSISTS OF  1)ADMINISTRATION OF NOVARTIS PHARMACEUTICAL ACTIGALL, OR AMIDE PHARMACEUTICAL URSODIOL, OR TEVA PHARMACEUTICAL URSODIOL (8-10 MG/KG/DAY) FOR AT LEAST TWO WEEKS PRE-LITHOTRIPSY,  2) LITHOTRIPSY TREATMENTS OF UP TO 2000 24 KV SHOCKS, AND  3) CONTINUED ADMINISTRATION OF URSODIOL UNTIL A STONE-FREE STATE IS ACHIEVED.
P000025|S002|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/2002|07/11/2002|||APPR|APPROVAL FOR THE REPLACEMENT OF COMBI 40+ COCHLEAR IMPLANT SYSTEM DOS BASED SOFTWARE WITH CI.STUDIO+, VERSION 1.0 SOFTWARE, FOR "REMOTE CONSULTATIVE SERVICES".
P000052|S006|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2002|08/02/2002|||APPR|APPROVAL FOR CHANGES TO COMPONENTS USED IN THE SDU HEAD AND CARTRIDGE OF THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM.  THE DEVICE MODIFICATIONS INCLUDE CHANGES TO THE EMERGENCY RETRACT SYSTEM, THE STOP COLLAR/WIRE DRIVES AND THE CARTRIDGE LATCHING MECHANISM.
P990034|S002|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED IMPLANTABLE INFUSION PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/2002|03/11/2002|||APPR|APPROVAL FOR:  1) PROPELLANT CHANGE FROM CFC-114 TO N-BUTANE;  2) CAPILLARY TUBING ADJUSTMENT AS A RESULT OF CHANGE TO N-BUTANE;  AND 3) UPDATES TO THE TECHNICAL MANUAL.
P960009|S024|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA PARKINSON CONTROL SYSTEM|MHY|NE|Real-Time Process|Other Report|N|02/25/2002|07/29/2002|||APPR|APPROVAL FOR MINOR CHANGES TO THE LABELING OF THE EXISTING MEDTRONIC ACCESS REVIEW MODEL 7438 THERAPY CONTROLLER TO BE USED WITH MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM.
P960013|S010|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2002|03/27/2002|||APPR|APPROVAL FOR THE LOCATOR STEERABLE STYLET MODEL 4036 FOR USE WITH TENDRIL DX MODEL 1388 T/TC/K AND TENDRIL SDX MODEL 1488 T/TC/K ENDOCARDIAL PACING LEADS.
P900043|S036|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM, BX VELOCITY STENT ON RAPTORRAIL TX DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/2002|08/22/2002|||APPR|APPROVAL TO AMEND THE LABELING (INSTRUCTIONS FOR USE) FOR THE DEVICES.
P900043|S037|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY WITH HEPACOAT ON RAPTOR STENT SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/2002|08/22/2002|||APPR|APPROVAL TO AMEND THE LABELING (INSTRUCTIONS FOR USE) FOR THE DEVICES.
P900043|S038|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/2002|08/02/2002|||APPR|APPROVAL FOR A MODIFICATION OF THE INDICATIONS FOR THE BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING:  1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<=30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM INVOLVING DIRECT STENTING OR PREDILATATION; AND  2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.0 MM.  THE 2.25 MM, 2.5 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
P980053|S004|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2002|07/30/2002|||APPR|APPROVAL FOR THE USE OF GRAPHITE BEAD SUBSTRATE MATERIAL AS AN ALTERNATE TO ZIRCONIUM OXIDE IN THE DEVICE.
P900060|S023|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2002|04/30/2002|||APPR|APPROVAL FOR THE REMOVAL OF THE BIOLITE CARBON COATING FROM THE SEWING CUFF OF THE ABOVE REFERENCED PRODUCTS.
P990037|S010|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2002|04/30/2002|||APPR|APPROVAL FOR CHANGING THE SUPPLIER FROM COOK PHARMACEUTICALS TO CHESAPEAKE BIOLOGICAL LABORATORIES.  THIS CHANGE WILL ALSO AFFECT THE APPROVED DILUENT.  SPECIFICALLY, THE CURRENT APPROVED BUFFERING AGENT COMPONENT, 0.1% TROLAMINE NF (TEA) WILL BE CHANGED TO 0.1% TROMETHAMINE USP (TRIS).
P910023|S060|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|PHOTON MICRO MODEL V-194, V-232 AND ATLAS MODEL V-199 , V-240 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2002|03/01/2002|||APPR|APPROVAL FOR AN ADDITIONAL SCREENING PROCEDURE TO CONFIRM OUTPUT FLEX PERFORMANCE.
P950034|S021|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2002|03/26/2002|||OK30|MANUFACTURING CHANGE TO REPLACE THE CURRENT MANUAL CLEANING PROCESS FOR REMOVING RESIDUAL MANUFACTURING MATERIALS FROM EQUIPMENT WITH A SEMI-AUTOMATIC SUBSTRATE WASHER.  THE SEMI-AUTOMATIC SUBSTRATE WASHER WOULD DECREASE THE TIME AND LABOR USED IN THE MANUFACTURING CLEANING PROCESS.
P880003|S084|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|RAPTORRAIL PTCA DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Express GMP Supplement|N|03/01/2002|04/16/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT CORDIS DE MEXICO SA DE CV, CHIHUAHUA, MEXICO.
P830061|S034|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE SENSE  LEAD MODELS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2002|07/23/2002|||APPR|APPROVAL FOR PACING LEADS THAT INCORPORATE A NEW SURFACE COATING, A NEW ELECTRODE GEOMETRY, A NEW COMBINATION OF PREVIOUSLY USED STEROIDS, AND A NEW TAPERED STYLET.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES CAPSURE SENSE LEAD MODELS 4074/4574/4073 AND THE VITATRON CRYSTALLINE LEAD MODELS ICM09B, ICM09JB, AND ICM09.  THESE DEVICES ARE INDICATED FOR PACING OR SENSING IN THE ATRIUM OR VENTRICLE.  THE LEADS HAVE APPLICATION WHERE IMPLANTABLE ATRIAL OR VENTRICULAR SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED.
P980035|S021|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 700 SERIES PULSE GENERATOR PRODUCT FAMILY|DXY|CV|Normal 180 Day Track|Express GMP Supplement|N|03/01/2002|03/18/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC ARIZONA DEVICE MANUFACTURING, TEMPE, ARIZONA.
P010015|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/2002|02/25/2003|||APPR|APPROVAL FOR THE INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE WHICH IS INDICATED AS FOLLOWS:  THE INSYNC III MODEL 8042 DEVICE IS INDICATED FOR THE REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III OR IV), IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35%, AND A QRS >=130 MS.  RATE ADAPTIVE PACING IS PROVIDED FOR THOSE PATIENTS DEVELOPING A BRADYCARDIA INDICATION WHO MIGHT BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASE IN ACTIVITY.  DUAL CHAMBER AND ATRIAL TRACKING MODES ARE INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.
P010034|S001|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/2002|05/07/2002|||APPR|APPROVAL FOR AN OVERALL UPGRADE TO THE HARDWARE AND SOFTWARE IN THE DEVICE.  THESE CHANGES IMPROVED THE SENSITIVITY, DECREASED THE MARKS PER CASE AND MADE AN IMPROVEMENT IN FALSE NEGATIVES.  IN ADDITION, SOFT-COPY, INCREASED STORAGE, AND DICOM INTERFACING WERE ADDED ALONG WITH SUNDRY OTHER OPERATING IMPROVEMENTS.
P000036|S002|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2002|03/19/2002|||APPR|APPROVAL FOR A CHANGE IN THE CAUTION STATEMENT IN THE DIRECTIONS FOR USE FROM "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE" TO "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE INDICATED ON THE LABELED UNIT CARTON."
P900056|S069|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2002|04/04/2002|||OK30|CHANGE IN THE QA AUDIT PROCESS.
P980016|S026|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2002|03/28/2002|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA FROM CLASS 10,000 TO A MINIMUM OF CLASS 100,000.
P990055|S004|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ACS:180 & ADVIA CENTAUR CPSA IMMUNOASSAYS|NAF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/2002|07/19/2002|||APPR|APPROVAL FOR THE ADJUSTMENT OF THE CALIBRATION OF THE DEVICE.
P890055|S014|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS|LKK|HO|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/07/2002|03/29/2002|||APPR|APPROVAL FOR AN ALTERNATE QUICK START TECHNIQUE TO THE PUMP IMPLANT PROCEDURE.
P970004|S022|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2002|09/24/2002|||APPR|APPROVAL FOR LEAD MODELS 3889 AND 3093 FOR USE WITH THE MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY RETENTION AND THE SYMPTOMS OF OVERACTIVE BLADDER, INCLUDING URINARY URGE INCONTINENCE AND SIGNIFICANT SYMPTOMS OF URGENCY-FREQUENCY ALONE OR IN COMBINATION, IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
P980009|S011|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|SCIMED MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/2002|04/12/2002|||APPR|APPROVAL FOR A MODIFICATION TO A PROCESS STEP IN WHICH THE MAGIC WALLSTENT DEVICE TIP IS INSERT-MOLDED ONTO THE INNER CATHETER SHAFT RATHER THAN ADHESIVELY ATTACHED.
P010015|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2002|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P980050|S012|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC JEWEL/GEM ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2002|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P980035|S022|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA/SIGMA PACEMAKER FAMILIES|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2002|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P980016|S027|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM & MARQUIS FAMILY ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2002|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P970012|S013|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|KAPPA 400 PACEMAKER FAMILY|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2002|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P930022|S001|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|LEGEND PLUS PACEMAKER FAMILY|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2002|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P850051|S057|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX PACEMAKER FAMILY|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2002|03/13/2002|||APPR|APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE.  IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P910073|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE/RELIANCE S STEROID ELUTING EXTENDABLE/RETRACTABLE HELIX ENDOCARDIAL DEFIBRILLATION LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/11/2002|07/25/2002|||APPR|APPROVAL FOR MODIFIED ACTIVE FIXATION DEFIBRILLATION LEADS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ENDOTAK RELIANCE AND RELIANCE/S LEADS AND IS INDICATED FOR PACING AND RATE-SENSING AND TO DELIVER CARDIOVERSION AND DEFIBRILLATION SHOCKS FOR AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS.
P810046|S212|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||CATHETER, FLOW DIRECTED|HIGHSAIL CORONARY DILATATION CATHETERS|DYG|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2002|05/10/2002|||APPR|APPROVAL TO MODIFY THE PACKAGING BY ELIMINATING THE FLUSHING TOOL AND REPLACING THE DISPENSER TUBING COIL.
P900056|S070|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2002|04/11/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO ELIMINATE THE POST-STERILIZATION VERIFICATION PROCESS.
P000039|S002|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/2002|05/03/2002|||APPR|APPROVAL FOR THE ADDITION OF A CAUTION LABEL.
P980035|S023|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 700/600/800/900 PULSE GENERATORS|DXY|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2002|03/15/2002|||APPR|APPROVAL FOR TWO CHANGES IN THE MANUFACTURING PROCESS INVOLVING THE EPOXY DISPENSE PROGRAM AND THE WIRE BOND LOOP PROGRAM.
P010030|S002|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST|MVK|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/2002|03/20/2002|||APPR|APPROVAL FOR A NEW TRADE NAME FOR THE WCD DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND EITHER ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P990066|S012|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2002|04/03/2002|||OK30|ADDITION OF A SUPPLIER OF THE HIGH VOLTAGE (HV) TANK ELECTRONIC BOARDS.  THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
P000008|S003|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track|Express GMP Supplement|N|03/13/2002|05/24/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MCGHAN MEDICO, BARREAL DE HEREDIA, COSTA RICA.
P970035|S035|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2002|04/11/2002|||OK30|CHANGE IN THE PROCESS OF FORMING THE RING OF THE STENT.
P000008|S004|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/2002|09/10/2002|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE LAP-BAND SYSTEM'S ACCESS PORT WITH TAPERED CONNECTOR.
P860003|S040|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/2002|04/12/2002|||APPR|APPROVAL FOR A LABELING CHANGE (INCLUSION OF AN ADDITIONAL WARNING) TO ADDRESS THE POTENTIAL FOR THE DEVELOPMENT OF HYPOVOLEMIA AND HYPOTENSION DURING PHOTOPHERESIS TREATMENTS IN PATIENTS WITH ELEVATED TRIGLYCERIDE LEVELS (HYPERLIPIDEMIA), SUCH AS PATIENTS RECEIVING CERTAIN CUTANEOUS T-CELL LYMPHOMA DRUGS, LIKE TARGRETIN. (BEXAROTENE).
P850010|S017|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/15/2002|04/03/2002|||APPR|APPROVAL FOR THE MARKETING OF THE HELITENE FIBRILS, IN A PAD FORM.
P000046|S002|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2002|08/30/2002|||APPR|APPROVAL FOR AN ADDITIONAL CLEANROOM AREA.
P000052|S007|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2002|04/17/2002|||OK30|CHANGES RELATED TO THE DISPLAY STOP SCREW AND THE MOTOR COUPLING SCREW IN MANUFACTURING THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM.
P960011|S008|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON(1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)|LZP|OP|Normal 180 Day Track|Express GMP Supplement|N|03/18/2002|04/01/2002|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION AND FINAL CARTONING FACILITY LOCATED AT MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA.
P930029|S017|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF ENHANCER 7 FRENCH, 5 MM ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2002|05/31/2002|||APPR|APPROVAL FOR ABLATION CATHETERS WHICH FEATURE DESIGN CHANGES TO THE PERFORMER CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER THE TRADE NAME RF ENHANCER 7FRENCH, 5 MM ABLATION CATHETER AND IS INDICATED FOR USE WITH THE MEDTRONIC RF POWER GENERATOR TO DELIVER RF ENERGY FOR INTRACARDIAC ABLATION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA FOR THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA AND FOR CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P910007|S008|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|IMX AND AXSYM PSA|LTJ|IM|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2002|09/05/2002|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
P890025|S014|Abbott Laboratories|ABBOTT LABS||ABBOTT PARK|IL|60064||FLUROESENCE POLORIZATION IMMUNOASSAY FOR CYCLOSPORINE|TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD|MGU|TX|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2002|09/05/2002|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
P970020|S042|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI LINK RX ZETA CORONARY STENT SYSTEM/ MULTI LINK OTW ZETA CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/2002|09/13/2002|||APPR|APPROVAL FOR THE MULTI-LINK RX AND OTW ZETA CORONARY STENT SYSTEMS.  THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING:  1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM.  2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <= 35 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM.  3) RESTORING CORONARY  FLOW IN PATIENTS EXPERIENCING ACUTE MYOCARDIAL INFARCTION, AS CONFIRMED BY ST SEGMENT ELEVATION OR ANGIOGRAPHIC FINDINGS, WHO PRESENT WITHIN 12 HOURS OF SYMPTOM ONSET WITH NATIVE CORONARY ARTERY LESIONS OF LENGTH <= MM WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM TO 4.0 MM.  4) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 2.5 MM TO 4.0 MM.  LONG-TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P940015|S006|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC HYLAN G-F 20|MOZ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2002|09/26/2003|||APPR|APPROVAL FOR LABELING CHANGES INCLUDING REMOVAL OF A PRECAUTION REGARDING REPEAT COURSES OF INJECTION, AND ADDING INFORMATION ABOUT ADVERSE EVENTS.
P970043|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Change Design/Components/Specifications/Material|N|03/18/2002|10/18/2002|02M-0487|11/18/2002|APPR|APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM.  THIS DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -7.0 DIOPTERS (D) AS MEASURED BY MANIFEST REFRACTION, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK):  1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE;  2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND  3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50 D.
P890003|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC PACING LEADS|DXY|CV|Normal 180 Day Track||N|10/15/2001|03/01/2002|||APPR|APPROVAL FOR MEDTRONIC MODEL 72 DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH M DR) APPLICATION SOFTWARE, MODEL 9990 DESKTOP SOFTWARE, MODEL 9322 PATIENT MAGNET, AND MODEL 9767/9767L TELEMETRY PROGRAMMING HEAD (TELEMETRY B).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC M DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P790018|S043|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT|LWQ|CV|Normal 180 Day Track|Express GMP Supplement|N|03/22/2002|04/09/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC, SPRING LAKE PARK, MINNESOTA.  MANUFACTURING OPERATIONS RELATED TO FABRICATION OF THE SEWING RING, ATTACHMENT OF THE CONDUIT AND SEWING RING TO THE DISC AND HOUSING SUBASSEMBLY, AND STERILE AND FINAL PACKAGING PROCESSES FOR THE MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT PROSTHESIS (MODEL R7700) WILL BE PERFORMED AT THIS FACILITY.
P810025|S020|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC/AMVISC PLUS SODIUM HYALURONATE|LZP|OP|Normal 180 Day Track|Express GMP Supplement|N|03/22/2002|07/19/2002|||APPR|APPROVAL FOR A NEW ASEPTIC MANUFACTURING SUITE LOCATED AT ANIKA THERAPEUTICS, INC., WOBURN, MASSACHUSETTS.
P000009|S004|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM|MRM|CV|Panel Track|Change Design/Components/Specifications/Material|N|03/22/2002|09/09/2002|07M-0408|11/09/2007|APPR|APPROVAL FOR THE TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, MODEL 122499 WITH SOFTWARE CARTRIDGE SWM / I-KDR.0.C, MODEL 339684.  THE DEVICE IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  THE DEVICE IS INDICATED FOR USE IN ICD PATIENTS WITH EITHER ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.
P990020|S008|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2002|04/23/2002|||OK30|CHANGE FROM A MANUAL INSPECTION PROCESS TO AN ELECTRONIC INSPECTION PROCESS FOR THE ANEURX STENT GRAFT SYSTEM.
P970035|S036|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 WITH DISCRETE TECHNOLOGY OVER-THE -WIRE CORONARY STENT SYSTEM/S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/2002|09/13/2002|||APPR|APPROVAL FOR THE FOLLOWING EXPANDED DEVICE INDICATIONS:  THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV 2000 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANTING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION.  LONG-TERM OUTCOME (BEYOND 180-DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT."  THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV100 BALLOON IS INDICATED FOR:  "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION.  LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT."  THE S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLOON IS INDICATED FOR:  "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING PREDILATATION.  LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  THE RAPID EXCHANGE DELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2 CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY.  THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND-ALONE PTCA PERFUSION CATHETER."  THE S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV100 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= MM) IN...
P000025|S003|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40 + COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2002|04/12/2002|||OK30|MANUFACTURING PROCESS CHANGE FOR THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.
P950032|S031|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/2002|04/09/2002|||APPR|APPROVAL FOR REVISIONS IN THE PRODUCT LABELING INCLUDING INCLUSION OF A STATEMENT CONCERNING THE VIRUS TESTING FOR EACH DONOR CELL STRAIN.
P780012|S013|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|IMX HAVAB|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2002|09/05/2002|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REGENT PACK IS PACKAGED.
P790019|S015|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|IMX HAVAB-M|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2002|09/05/2002|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
P990075|S007|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SPECTRUM SALINE-FILLED MAMARY PROSTHESES|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2002|04/23/2002|||OK30|CHANGE OF A SUPPLIER OF SILICONE GEL MATERIALS USED IN THE LUBRICATION OF THE SPECTRUM VALVE CHANNEL IN THE MENTOR SPECTRUM SALINE-FILLED BREAST IMPLANTS.  THERE WILL BE NO CHANGES IN ANY MANUFACTURING PROCESSES.
P960043|S038|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|THE CLOSURE 6 FR., S 6 FR. AND II 6 FR. SUTURE MEDIATED CLOSURE SYSTEMS|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2002|04/29/2002|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE SUTURE TRIMMER, AN ACCESSORY DEVICE TO THE CLOSER SYSTEMS PREVIOUSLY APPROVED UNDER PMAS P960043/S027 AND S032.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUTURE TRIMMER AND IS INDICATED, AS AN ACCESSORY DEVICE, FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS.  THE CLOSER II 6 FR. SMC SYSTEM REDUCES THE TIME TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS.
P920004|S018|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL ELITE VHD/ES DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/2002|08/13/2002|||APPR|APPROVAL FOR THE USE OF A SINGLE SPONGE COLLAGEN PLUG.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES VASOSEAL ELITE VHD OR ES DEVICE AND IS INDICATED FOR:  "SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH.  THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS, AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES.  IN ADDITION, THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO DISCHARGE IN DIAGNOSTIC PATIENTS RECEIVING 5-6 FRENCH PROCEDURAL SHEATHS.  VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS IN INTERVENTIONAL, PATIENTS, WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED."  THE VASOSEAL ELITE VHD DEVICE INDICATIONS INCLUDE THE STATEMENT: "HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DETERMINED."
P990053|S006|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2002|01/07/2003|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE N-400 FETAL PULSE OXIMETER.  THE MANUFACTURING SITE IS LOCATED AT NELLCOR PURITAN BENNETT IRELAND, GALWAY, IRELAND.
P000021|S002|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION TPSA FLEX REAGENT CARTRIDGE|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/2002|09/10/2002|||APPR|APPROVAL FOR DESIGN CHANGES.  THE DESIGN CHANGES INCLUDE MODIFICATION OF THE ASSAY RESPONSE TO PROVIDE EQUIVALENT RESULTS FOR SAMPLES WITH VARYING MIXTURES OF FREE PSA AND PSA-ACT AND OPTIMIZATION OF THE METHOD DESIGN TO MINIMIZE METHOD RESPONSE TO HUMAN ANTI-MURINE IMMUNOGLOBULIN ANTIBODIES AND HUMAN ANTI-BOVINE IMMUNOGLOBULIN ANTIBODIES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIMENSION TPSA FLEX REAGENT CARTRIDGE AND IS INDICATED FOR:  THE TPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM AND PLASMA:  1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER  2) AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
P870072|S019|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/2002|04/18/2002|||APPR|APPROVAL FOR ADDITION OF A CAUTION STATEMENT TO THE PACKAGE LABELING.
P980016|S028|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 2490A CARELINK MONITOR AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE MODEL 2491 VERSION 1.0|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/27/2002|04/16/2002|||APPR|APPROVAL FOR EXPANSION OF THE FUNCTIONALITY OF THE MODEL 2490A CARELINK MONITOR AND MODEL 2491 SOFTWARE, VERSION 1.0 TO INCLUDE THE GEM, GEM DR, GEM II VR, GEM II DR, GEM III VR AND GEM III DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P830055|S082|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Express GMP Supplement|N|03/28/2002|10/04/2002|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY LOCATED AT ISOTRON, BERKSHIRE, ENGLAND.
P830037|S045|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2002|05/01/2002|||APPR|APPROVAL FOR A CHANGE OF TINT FROM PHTHALOCYANINE GREEN TO CARBAZOLE VIOLET FOR FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) UV SOFT (HYDROPHILIC) CONTACT LENSES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION:  FRESHLOOK SPHERICAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 2.0 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  FRESHLOOK TORIC (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 6.0 DIOPTERS.  FRESHLOOK BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY AND PRESBYOPIA IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO .75 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR IN NOT-APHAKIC PERSONS FROM 1-7 DAYS BETWEEN REMOVAL FOR CLEANING AND DISINFECTION OR DISPOSAL, AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THE EYE CARE PRACTITIONER MAY PRESCRIBE THE LENS IN EITHER A SINGLE USE DISPOSABLE PROGRAM OR IN A FREQUENT REPLACEMENT PROGRAM WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT.  WHEN PRESCRIBED IN A FREQUENT REPLACEMENT PROGRAM, THE LENS MAY BE DISINFECTED USING A CHEMICAL (HOT HEAT) DISINFECTION SYSTEM.  FRESHLOOK LENSES WITH UV ABSORBING MONOMER HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
P990055|S005|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|IMMUNO 1 COMPLEXED PSA ASSAY|NAF|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/28/2002|09/04/2002|||APPR|APPROVAL FOR LABELING CHANGES.  THE LABELING CHANGES INCLUDE THE REVISION OF LITERATURE CITED IN THE SUMMARY AND EXPLANATION SECTION AND THE ADDITION OF SUMMARY DATA FROM A NEW CLINICAL STUDY.  THERE IS NO CHANGE IN THE INDICATION FOR USE.
P010025|S001|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/29/2002|10/02/2002|||APPR|APPROVAL FOR AN AMORPHOUS SELENIUM DIGITAL RECEPTOR, A CHANGE IN THE NAME OF THE PRODUCT TO SELENIA AND THE ADDITION OF A SOFT COPY DISPLAY FOR INTERPRETATION OF SCREENING AND DIAGNOSTIC MAMMOGRAMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM AND IS INDICATED FOR GENERATING DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER.  THE SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM MAMMOGRAPHIC SYSTEMS.  MAMMOGRAPHIC IMAGES CAN BE INTERPRETED ON EITHER HARD COPY FILM OR THE SELENIA SOFT COPY REVIEW WORKSTATION.  ALSO, APPROVAL FOR THE ADDITION OF THE LORAD FACILITY, DANBURY, CONNECTICUT, AS A MANUFACTURING SITE FOR THE SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
P940015|S007|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC(HYLAN G-F 20)|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/2002|04/26/2002|||APPR|APPROVAL FOR THE ADDITION OF THE FOLLOWING STATEMENT TO THE SYNVISC PHYSICIAN PACKAGE INSERT: "PRECAUTION: DO NOT OVER TIGHTEN OR APPLY EXCESSIVE LEVERAGE WHEN ATTACHING THE NEEDLE OR REMOVING THE NEEDLE GUARD, AS THIS MAY BREAK THE TIP OF THE SYRINGE."
P000052|S008|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2002|08/09/2002|||APPR|APPROVAL FOR A MANUFACTURING CHANGE, USING AN AUTOMATED SOURCE WIRE QUALITY CONTROL MACHINE AS AN ALTERNATIVE TO MANUAL SOURCE WIRE FINAL TESTING AND INSPECTION.
P970008|S020|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR TREATMENT OF BPH|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/2002|04/10/2002|||APPR|APPROVAL FOR CHANGES TO THE "CONTRAINDICATIONS" AND PRECAUTIONS" SECTIONS OF THE LABELING.
P860003|S041|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2002|11/25/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT MACK MOLDING COMPANY, ARLINGTON, VERMONT.  THE FACILITY WILL MANUFACTURE THE XTS INSTRUMENT AND XT20 LIGHT ASSEMBLY.
P990025|S004|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|QWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12)|DRF|CV|Normal 180 Day Track||N|04/01/2002|12/18/2002|||APPR|APPROVAL FOR A NEW INTERFACE CABLE AND DESIGN CHANGES (E.G., ADDITIONAL LOCATION SENSOR) TO THE CATHETER PREVIOUSLY APPROVED UNDER P990025 AND IT'S SUPPLEMENTS, IN ORDER TO ENABLE ADDITIONAL MAPPING CAPABILITIES.
P790017|S077|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|STORMER ZIPPER MX BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/2002|09/18/2002|||APPR|APPROVAL FOR THE STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY, WHICH IS INDICATED FOR BALLOON DILATATION OF THE STENOIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P860019|S180|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|SCIMED NC RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER|LOX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/04/2002|10/01/2002|||APPR|APPROVAL FOR MINOR CHANGES TO THE BALLOON CATHETER COMPLIANCE CHARTS IN THE PRODUCT LABELING.
P990042|S003|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-AUK PLUS ASSAY|LOM|MI|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|04/04/2002|06/24/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.  THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE MARCH 30, 2001 APPROVAL ORDER FOR P990042.
P800035|S011|CURASAN AG|LINDIGSTRASSE 4||KLEINOSTHEIM||D-638|6380|Bone grafting material, for dental bone repair|CERASORB DENTAL|LPK|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/2002|12/08/2003|||APPR|APPROVAL FOR DESIGN CHANGES, A TRADE NAME CHANGE, AND NEW MANUFACTURING SITES.  THIS APPROVAL ALSO ACKNOWLEDGES THAT OWNERSHIP HAS BEEN TRANSFERRED FROM MITER, INC. TO CURASAN AG.  CERASORB DENTAL WILL BE MANUFACTURED AT TWO NEW FACILITIES LOCATED AT CURASAN AG, GERMANY AND WILLY RUSCH AG, GERMANY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERASORB DENTAL AND IS INDICATED FOR DEFECTS AFTER EXTIRPATION OF DENTAL ALVEOLAR CYSTS; REPAIR OF MARGINAL AND PERIAPICAL PERIODONTAL ALVEOLAR BONY POCKETS AS WELL AS BIFURCATIONS AND TRIFURCATIONS OF THE TEETH; AUGMENTATION OF THE ATROPHIED ALVEOLAR RIDGE; ALVEOLAR AUGMENTATION OF MANDIBULAR AND MAXILLARY RIDGES; DEFECTS AFTER APICOECTOMY; AND FILLING BONE DEFECTS AFTER SURGICAL RESECTION OF IMPACTED TEETH (WITHOUT IMPLANTATION).
P990053|S007|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2002|04/18/2002|||OK30|CHANGE IN THE MANUFACTURING SITE FOR THE FETAL SENSOR EMITTER, A COMPONENT OF THE OXIFIRST FETAL SENSOR.  THE SENSOR EMITTER WILL BE MANUFACTURED AT THE TYCO FACILITY IN INSURGENTES, TIJUANA, MEXICO,  WHERE THE FETAL SENSORS ARE MANUFACTURED.
P010019|S001|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|04/05/2002|07/05/2002|||APPR|APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.  THE POST-APPROVAL STUDY PROTOCOL WAS SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE OCTOBER 11, 2001 APPROVAL ORDER FOR P010019.
P980035|S024|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 700 SERIES OF IPGS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2002|05/07/2002|||OK30|CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA FROM CLASS 10,000 TO A MINIMUM OF CLASS 100,000.
P980043|S001|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510|DYE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/08/2002|04/16/2002|||APPR|APPROVAL TO REVISE ONE CAUTION STATEMENT AND TO INCLUDE REFERENCES TO A NEW VALVE HANDLE (MODEL 7639) WITHIN THE INSTRUCTIONS FOR USE.
P900043|S039|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM(RX)/BX VELOCITY STENT WITHHEPACOAT ON RAPTORRAIL STENT DELIVERY|MAF|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2002|05/03/2002|||APPR|APPROVAL FOR FOUR CHANGES TO THE QUALITY PLAN FOR THE DEVICE.
P010030|S003|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WCD 3000 SYSTEM|MVK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/2002|10/09/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE WCD MONITOR (P010030/S001) AND ELECTRODE BELT/CHEST GARMENT SYSTEM (P010030/S003).  THE SYSTEM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3000 SYSTEM AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND EITHER ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P790027|S067|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|PMMA INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|04/08/2002|05/21/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT BAUSCH & LOMB, INC. WILMINGTON, MASSACHUSETTS.  THE CLEAR COMPRESSION MOLDED BLANK PMMA MATERIAL WILL BE MANUFACTURED AT THIS FACILITY.
P790002|S022|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM - MODEL 2001|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/2002|08/13/2002|||APPR|APPROVAL FOR VARIOUS HARDWARE AND SOFTWARE CHANGES.
P840039|S050|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|PMMA INTAOCULAR LENS|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|04/08/2002|05/21/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT BAUSCH & LOMB, INC. WILMINGTON, MASSACHUSETTS.  THE CLEAR COMPRESSION MOLDED BLANK PMMA MATERIAL WILL BE MANUFACTURED AT THIS FACILITY.
P980023|S008|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|BELOS VR-T ICD|DTA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/08/2002|04/24/2002|||APPR|APPROVAL FOR THE BELOS VR-T ICD HOME MONITORING SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BELOS VR-T ICD WITH PROGRAMMER SOFTWARE (I-K01.0.A/5) AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P010049|S001|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL ARTERIAL CLOSURE SYSTEM WITH Q-FOAM|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/2002|09/16/2002|||APPR|APPROVAL FOR A CHANGE IN HEMOSTATIC MATERIAL FROM GELFOAM TO Q-FOAM.
P980003|S005|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/2002|06/28/2002|||APPR|APPROVAL FOR:  1) USE OF A COMPATIBLE RADIOFREQUENCY (RF) GENERATOR FOR DELIVERY OF RF ENERGY THROUGH THE TIP OF THE CHILLI COOLED ABLATION CATHETER AND THE ADDITION OF ACCESSORIES TO CONNECT THE CATHETER TO THE RF GENERATOR;  2) A TEMPERATURE SENSOR CONVERTER (MODEL 2067 THERMOCOUPLE TO THERMISTOR TRANSLATOR (TTT) MODULE) FOR THE THERMOCOUPLE OUTPUT OF THE CHILLI COOLED ABLATION CATHETER TO THE THERMISTOR INPUT OF THE COMPATIBLE RF GENERATOR; AND  3) A SEPARATE, COMPATIBLE PUMP (MODEL 8005 PUMP SYSTEM) FOR DELIVERY OF FLUID FLOW THROUGH THE TIP OF THE CHILLI/COOLED ABLATION CATHETER AND A NEW TUBING KIT ACCESSORY (MODEL 2104 STERILE DISPOSABLE TUBE SET) WHICH CONNECTS THE CATHETER TO THE PUMP.
P900056|S071|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2002|05/02/2002|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM.  THE CHANGE INVOLVES A REDUCTION IN THE NUMBER OF AUDIT SAMPLES TAKEN FOR DESTRUCTIVE PULL TESTING FROM THE LASER SUBASSEMBLY LINE.
P860019|S181|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK MONORAIL/OVER THE WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PICA) CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2002|04/24/2002|||OK30|ALTERNATE MANUFACTURING PROCESS TO PRODUCE BALLOONS FOR THE MAVERICK MONORAIL PTCA CATHETER AND THE MAVERICK OTW PTCA CATHETER.  THE ALTERNATE PROCESS AFFECTS ONLY THE METHOD OF STRETCHING THE BALLOON TUBING PRIOR TO MOLDING THE BALLOON.
P990054|S004|Boston Scientific Corp.|2710 ORCHARD PKWY.||SAN JOSE|CA|95113||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/2002|06/28/2002|||APPR|APPROVAL FOR:  1) USE OF A COMPATIBLE RADIOFREQUENCY (RF) GENERATOR FOR DELIVERY OF RF ENERGY THROUGH THE TIP OF THE CHILLI COOLED ABLATION CATHETER AND THE ADDITION OF ACCESSORIES TO CONNECT THE CATHETER TO THE RF GENERATOR;  2) A TEMPERATURE SENSOR CONVERTER (MODEL 2067 THERMOCOUPLE TO THERMISTOR TRANSLATOR (TTT) MODULE) FOR THE THERMOCOUPLE OUTPUT OF THE CHILLI COOLED ABLATION CATHETER TO THE THERMISTOR INPUT OF THE COMPATIBLE RF GENERATOR; AND  3) A SEPARATE, COMPATIBLE PUMP (MODEL 8005 PUMP SYSTEM) FOR DELIVERY OF FLUID FLOW THROUGH THE TIP OF THE CHILLI/COOLED ABLATION CATHETER AND A NEW TUBING KIT ACCESSORY (MODEL 2104 STERILE DISPOSABLE TUBE SET) WHICH CONNECTS THE CATHETER TO THE PUMP.
P970015|S020|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|LT-CAGE TAPERED FUSION DEVICE|MAX|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/04/2002|08/12/2002|||APPR|APPROVAL FOR A REVISED LAPAROSCOPIC SURGICAL TECHNIQUE FOR IMPLANTATION OF THE LT-CAGE.  THE DEVICE REMAINS MARKETED UNDER THE TRADE NAME LT-CAGE TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FORM L2-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL.  LT-CAGE IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH.  PATIENTS RECEIVING THE LT-CAGE LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TREATMENT WITH THE LT-CAGE.
P940022|S020|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|BTE(BEHIND-THE-EAR)T-MIC|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/12/2002|04/23/2002|||APPR|APPROVAL FOR THE BTE T-MIC, AND IN-THE-EAR MICROPHONE ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR, AND APPROVAL OF THE HIFOCUS I SURGICAL INSTRUCTION VIDEO, WHICH WILL BE DISTRIBUTED AS PART OF THE SURGEON'S KIT.
P960058|S020|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|BTE(BEHIND-THE-EAR)T-MIC|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/12/2002|04/23/2002|||APPR|APPROVAL FOR THE BTE T-MIC, AND IN-THE-EAR MICROPHONE ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR, AND APPROVAL OF THE HIFOCUS I SURGICAL INSTRUCTION VIDEO, WHICH WILL BE DISTRIBUTED AS PART OF THE SURGEON'S KIT.
P850020|S015|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA COLUMN|LKN|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2002|05/15/2002|||OK30|REDUCTION IN THE TIME OF THE REACTION STEP IN THE MANUFACTURING PROCESS AND A DECREASE IN THE AMOUNT OF CARBODIIMIDE USED IN THE PROCESS.
P980022|S008|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2002|09/05/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE AND A DESIGN MODIFICATION OF THE GLUCOSE SENSOR COMPONENT OF THE CONTINUOUS GLUCOSE MONITORING SYSTEM.
P000037|S002|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2002|10/11/2002|||APPR|APPROVAL FOR A MODIFIED AORTIC SEWING CUFF AS AN EXTENSION TO THE LINE OF AVAILABLE VALVES; THE REQUEST APPLIED TO THE AORTIC SIZES 19, 21, 23, 25, AND 27/29 MM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE AND WILL BE GIVEN THE MODEL DESIGNATION OF MODEL ONXAC AND IS INDICATED FOR REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE AORTIC POSITION.
P860019|S182|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2002|10/01/2002|||APPR|APPROVAL FOR THE QUANTUM MAVERICK MONORAIL AND OTW PTCA CATHETERS AND APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY, COSMED OF RI, COVENTRY, RHODE ISLAND.  THE QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS ARE AVAILABLE IN LENGTHS OF 8, 12, 15, 20 AND 30 MM, WITH DIAMETERS RANGING FROM 2.00 TO 4.00 MM IN 1/4MM INCREMENTS AND 4.5 TO 5.0 MM IN 1/2 MM INCREMENTS (EXCEPT FOR THE 20 MM LENGTH). THE DEVICES, AS MODIFIED, ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND FOR THE POST DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P990025|S005|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER|DRF|CV|Normal 180 Day Track|Express GMP Supplement|N|04/17/2002|11/13/2002|||APPR|APPROVAL FOR THE STERILIZATION FACILITY LOCATED AT COSMED OF CALIFORNIA, SAN DIEGO, CALIFORNIA.
P990053|S008|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2002|11/25/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT NELLCOR PURITAN BENNETT, INC., MINNEAPOLIS, MINNESOTA.  FACTORY SERVICE OPERATIONS FOR THE N-400 FETAL OXYGEN SATURATION MONITORS WILL BE PERFORMED AT THIS FACILITY.
P960043|S039|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|THE CLOSER AK 6 FR. SMC DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2002|05/21/2002|||APPR|APPROVAL FOR MANUFACTURING AND MATERIAL DESIGN CHANGES, I.E., CHANGING TO A PRESS-FIT HANDLE, TO A GREEN AND WHITE SUTURE, TO AN INTERNAL SUTURE STORAGE, CHANGING THE THUMB CAP/PLUNGER ATTACHMENT BACK TO WHAT WAS PREVIOUSLY APPROVED IN P960043/S036, AND A CHANGE IN THE O-RING MATERIAL.  IN ADDITION, THE LABELING IS BEING MODIFIED TO INCLUDE OTHER HEALTHCARE PROFESSIONALS IN THE PRECAUTION ON THE LIMITATION OF USE TO PHYSICIANS WHO HAVE BEEN TRAINED IN THE USE OF THIS DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLOSER AK 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS.  THE CLOSER 6 FR. SMC SYSTEMS REDUCE THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS).
P000046|S003|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|COEASE SODIUM HYALURONATE|LZP|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2002|05/08/2002|||APPR|APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH ADVANCED MEDICAL OPTICS.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME COEASE SODIUM HYALURONATE AND WILL BE DISTRIBUTED IN VOLUMES OF 0.5 ML AND 0.8 ML.
P970003|S039|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESES(NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2002|06/18/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 402 TUNNELING TOOL (VERSION 1), RESULTING IN THE NEW VNS THERAPY TUNNELER, MODEL 402 (VERSION 2), AND MODIFICATIONS TO THE EXISTING MODEL 500 ACCESSORY PACK, RESULTING IN THE NEW VNS THERAPY ACCESSORY PACK, MODEL 502.
P010040|S001|RedHawk Medical Products & Services LLC|P.O. Box 53929||Lafayette|LA|70505|3929|Device, needle destruction|THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE|MTV|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|04/16/2002|04/18/2002|||APPR|APPROVAL FOR A CHANGE IN THE DEVICE TO ADD A PORT FOR DESTRUCTION OF LANCETS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DISINTEGRATOR PLUS NEEDLE DESTRUCTION UNIT AND IS INDICATED FOR HOME USE TO DESTROY 27 TO 30 GAUGE INSULIN HYPODERMIC NEEDLES FROM 5/16 TO = INCHES IN LENGTH, ATTACHED TO INSULIN PENS AND DISPOSABLE INSULIN SYRINGES OF 1/3 CC TO 1.0 CC VOLUME IN SIZE AND LANCETS.
P980001|S039|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760||STENT, CORONARY|NIR STENT DELIVERY SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2002|05/01/2002|||OK30|MANUFACTURING PROCESS CHANGE TO REMOVE THE STENT SECUREMENT AUDIT.
P990053|S009|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXI FIRST FETAL OXYGEN  SATURATION MONITORING SYSTEM|MMA|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2002|11/25/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT NELLCOR PURITAN BENNETT, INC., MINNEAPOLIS, MINNESOTA.  THIS FACILITY WILL PERFORM MANUFACTURING OF THE FSP02-PM FETAL PATIENT MODULES.
P990015|S001|LIFECORE BIOMEDICAL, INC.|3515 LYMAN BLVD.||CHASKA|MN|55318||BARRIER, ABSORABLE, ADHESION|GYNECARE INTERGEL ADHESION PREVENTION SOLUTION|MCN|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2002|07/09/2002|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY FOR THE BLOW/FILL/SEAL AND ASEPTIC FILLING OF THE GYNECARE INTERGEL ADHESION PREVENTION SOLUTION.  THE FACILITY IS LOCATED AT CARDINAL HEALTH MANUFACTURING SERVICES, AUTOMATIC LIQUID PACKAGING, INC., WOODSTOCK, ILLINOIS.
P970003|S040|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/19/2002|06/20/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 101 (VERSION 2) IN-LINE NCP PULSE GENERATOR AND MODEL 302 (VERSION 1) IN-LINE NCP BIPOLAR LEAD, RESULTING IN THE NEW VNS THERAPY PULSE, MODEL 102 GENERATOR AND THE VNS THERAPY LEAD, MODEL 302 (VERSION 1.1).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VNS THERAPY SYSTEM.
P980049|S008|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2002|02/14/2003|||APPR|APPROVAL FOR A DEFIBRILLATION LEAD PREVIOUSLY APPROVED FOR MANUFACTURE BY ANGEION UNDER THE TRADE NAME ANGEPASS.  THE LEAD IS NOW BEING MANUFACTURED BY ELA MEDICAL, S.A.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SWIFT 1CT 4040 SERIES LEAD AND IS INDICATED FOR USE WITH AN ELA MEDICAL ICD IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS:  1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA;  2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYARRHYTHMIA.
P010049|S002|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/2002|06/13/2002|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE OF THE APPROVED QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM FROM 6 TO 24 MONTHS.
P990033|S004|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15 AND PEPGEN P-15 FLOW|NPZ|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/2002|06/14/2002|||APPR|APPROVAL FOR THE ADDITION OF THE FOLLOWING INDICATIONS FOR USE; AUGMENTATION OF BONY DEFECTS OF THE ALVEOLAR RIDGE, FILLING TOOTH EXTRACTION SITES, AND SINUS ELEVATION GRAFTING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PEPGEN P-15 AND PEPGEN P-15 FLOW.
P880013|S009|NELLCOR PURITAN BENNETT, INC.|2200 FARADAY AVE.||CARLSBAD|CA|92008|7208|VENTILATOR, HIGH FREQUENCY|NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Express GMP Supplement|N|04/22/2002|12/17/2002|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT NELLCOR PURITAN BENNETT, INC., MINNEAPOLIS, MINNESOTA.
P970035|S038|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/23/2002|10/15/2002|||APPR|APPROVAL FOR THE FOLLOWING TRADE NAMES AND EXPANDED DEVICE INDICATIONS:  THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV2000 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <=30 MM) IN NATIVE CORONARY ARTERIES AND SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION.  LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT."  THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV100 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <=30 MM) IN NATIVE CORONARY ARTERIES AND SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION.  LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT."  THE S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <=30 MM) IN NATIVE CORONARY ARTERIES AND SAPHEOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION.  LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.  THE RAPID EXCHANGE DELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2 CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY.  THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND-ALONE PTCA PERFUSION CATHETER."  THE S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV100 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH...
P860004|S050|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|VASCULAR CATHETER|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|04/23/2002|05/02/2002|||APPR|APPROVAL FOR CATHETER MODEL 8708 IN WHICH THE STRAIGHT CONNECTOR IS REPLACED WITH RIGHT ANGLE CONNECTOR, THE NUMBER OF ANCHOR BEADS IS INCREASED TO 12.  ALSO, REMOVAL OF ACCESSORY COMPONENTS SPECIFIED AS GUIDE WIRE, TUNNELING ACCESSORIES AND TWO PRE-ATTACHED ANCHORS FROM MODEL 8700A, 8700V AND 8702 PACKAGE.  THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER THE TRADE NAME MEDTRONIC VASCULAR CATHETER MODEL 8708 AND IS INDICATED FOR USE WITH THE MEDTRONIC IMPLANTABLE INFUSION PUMPS TO PROVIDE FLUID PATHWAY.
P970035|S039|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S670 W/DISCRETE TECHNOLOGY(TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/24/2002|04/17/2003|||APPR|APPROVAL TO UPDATE THE LABELING OF THE S670 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS TO INCLUDE POST-PROCEDURE RESULTS FOR THE PREDICT STUDY POPULATION AND REMOVE REFERENCES TO THE EUROPEAN RACECAR STUDY.
P930031|S013|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS|MIR|CV|Normal 180 Day Track|Express GMP Supplement|N|04/24/2002|05/10/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE STENT COMPONENT OF THE WALLSTENT PRODUCTS LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND.
P940019|S011|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS, ILIAC, VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|04/24/2002|05/10/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE STENT COMPONENT OF THE WALLSTENT. PRODUCTS LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND.
P980033|S002|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|04/24/2002|05/10/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE STENT COMPONENT OF THE WALLSTENT. PRODUCTS LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND.
P960043|S040|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|THE CLOSER S 6FR. SMC|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2002|06/05/2002|||APPR|APPROVAL TO MODIFY THE OUTER DIAMETER OF THE NEEDLE SHAFT OF THE CLOSER S 6 FR. SMC, FROM 0.020" (INCHES) TO 0.022".
P970003|S041|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/29/2002|06/18/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 250 PROGRAMMING SOFTWARE VERSION 6.1 (BUILD 4), RESULTING IN THE NEW VERSION 6.1 (BUILD 5).
P990030|S004|ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Agent, absorbable hemostatic, collagen based|COSTASIS SURGICAL HEMOSTAT|LMF|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2002|06/13/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COHESION TECHNOLOGIES, PALO ALTO, CALIFORNIA.
P970003|S042|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2002|07/29/2002|||APPR|APPROVAL FOR MINOR LABELING MODIFICATIONS TO THE EXISTING MODEL 100/101 NCP PULSE GENERATOR PHYSICIAN'S MANUAL.
P000018|S021|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH XL DELIVERY CATHETER - 60 MM|MOU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/01/2002|10/25/2002|||APPR|APPROVAL FOR THE 60 MM BETA-CATH XL DELIVERY CATHETER.
P990052|S008|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE SYSTEM|MPV|EN|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2002|07/02/2002|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING SPECIFICATION CRITERIA FOR THE FLOATING MASS TRANSDUCER.
P980043|S002|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS MODEL T505 (AORTIC)|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2002|10/28/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE VALVE HOLDERS FOR THE HANCOCK II BIOPROSTHESIS.  THE HOLDERS ARE TO BE USED WITH THE FOLLOWING APPROVED VALVE MODELS AND SIZES: HANCOCK II PORCINE BIOPROSTHESIS, MODEL T505 (AORTIC, SIZES 21, 23, 25, 27, AND 29 MM.  THESE AORTIC VALVES ARE INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P860004|S051|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|04/29/2002|05/14/2002|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO INTRATHECAL CATHETER MODEL 8711:  1) ADDITION OF NUMERICAL MARKINGS (IN CM) ON THE CATHETER TUBING,  2) CHANGE IN V-WING ANCHOR MATERIAL FOR IMPROVED VISIBILITY,  3) REMOVAL OF PROXIMAL ANCHOR; TUNNELING ROD TIPS AND WRENCH FROM THE CATHETER KIT, AND  4) UPDATE MODEL 8711 TECHNICAL MANUAL TO PROVIDE DETAILED INSTRUCTIONS AND CAUTIONS.
P990046|S006|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET|LWQ|CV|Normal 180 Day Track|Express GMP Supplement|N|05/01/2002|05/29/2002|||APPR|APPROVAL TO TRANSFER THE MANUFACTURING OF THE PYROLYTIC CARBON COATED HEART VALVE COMPONENTS FROM SULZER CARBOMEDICS, INC., TO ATS MEDICAL INC., MINNEAPOLIS, MINNESOTA.
P860019|S183|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK XL PTCA CATHETER (MONORAIL)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/2002|10/24/2002|||APPR|APPROVAL FOR MAVERICK XL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PTCA) CATHETERS (MONORAIL) AND APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY, COSMED OF RI, COVENTRY, RHODE ISLAND.  THE MAVERICK XL PTCA CATHETERS ARE AVAILABLE IN LENGTHS OF 15 AND 20 MM, WITH DIAMETERS OF 4.0, 4.5, 5.0, 5.5 AND 6.0 MM.  THE DEVICES, AS MODIFIED, ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND FOR THE POST DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P010003|S001|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2002|07/29/2002|||APPR|APPROVAL FOR  1) ADDING AN ADDITIONAL VENDOR, DOMNICK HUNTER, PLC, FOR THE 0.2 UM-FILTER TO FILTER BULK COMPONENT SOLUTIONS, AND  2) ADDING A SOLUTION MIXING SYSTEM FOR THE BOVINE SERUM ALBUMIN BULK SOLUTION FOR BAGS UP TO 20L IN CAPACITY.
P990064|S007|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS MODEL 305 (AORTIC)|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/2002|10/28/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE VALVE HOLDERS FOR THE MOSAIC BIOPROSTHESIS.  THE HOLDERS ARE TO BE USED WITH THE FOLLOWING APPROVED VALVE MODELS AND SIZES: MOSAIC PORCINE BIOPROSTHESIS, MODEL 305 (AORTIC, SIZES 19, 21, 23, 25, 27, AND 29 MM.  THESE AORTIC VALVES ARE INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P830039|S011|MEDICALCV, INC.|9725 SOUTH ROBERT TRAIL||INVER GROVE HEIGHTS|MN|55077||HEART-VALVE, MECHANICAL|OMNICARBON CARDIAC VALVE PROSTHESIS|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/07/2002|10/29/2002|||APPR|APPROVAL FOR THE OMNICARBON CARDIAC VALVE PROSTHESIS IN THE ADDITIONAL SIZE OF 21 MM OF THE MODEL 3313 (AORTIC) AND SIZE 25 MM OF THE MODEL 3523 (MITRAL).  THE SUPPLEMENT REQUESTED APPROVAL OF THESE SIZES AS AN ADDITION TO THE EXISTING, APPROVED (JULY 26, 2001; P830039/S007) PRODUCT LINE OF AORTIC SIZES 23, 25, 27 AND 29 MM, AND MITRAL SIZES 27, 29, 31, AND 33 MM.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL VALVES.
P010012|S001|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD SYSTEM|NIK|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|05/07/2002|05/20/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P860004|S052|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC N'VISION PROGRAMMING SYSTEM AND SYNCHRONMED APPLICATION SOFTWARE|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/07/2002|10/29/2002|||APPR|APPROVAL FOR THE MEDTRONIC N'VISION PROGRAMMING SYSTEM AND SYNCHROMED APPLICATION SOFTWARE.
P010013|S002|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2002|06/05/2002|||OK30|MODIFICATIONS TO THE MANUFACTURING PROCESSES FOR THE NOVASURE DISPOSABLE DEVICE, INCLUDING INJECTION MOLDING OF THE PLASTIC COMPONENTS, INCORPORATION OF THE NON-CONDUCTING LINES OF THE ARRAY INTO THE PEAK II KNITTING PROCESS, AND THE INCORPORATION OF THREE SEPARATE TUBES INTO A SINGLE MULTI-LUMEN EXTRUSION.
P810044|S004|DIABETES SENTRY PRODUCTS, LLC|501 Samuels Ave.|Unit #110|Fort Worth|TX|76102||MONITOR, SKIN RESISTANCE/SKIN TEMPERATURE,  FOR INSULIN REACTIONS|SLEEP SENTRY|LMY|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/2002|06/12/2003|||APPR|APPROVAL FOR CHANGES TO THE PHYSICAL DESIGN AND LAYOUT OF THE DEVICE, DEVICE LABELING, AND MANUFACTURING FACILITIES AND PROCESSES.  THE MANUFACTURING SITES ARE LOCATED AT DIABETES SENTRY PRODUCTS, INC. (DSP), BELLINGHAM WASHINGTON AND DATREND SYSTEMS, INC., RICHMOND, BC CANADA.
P840001|S061|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2002|10/31/2002|||APPR|APPROVAL FOR THE MODEL 8870 N'VISION APPLICATION CARD.  THE MODEL 8870 N'VISION APPLICATION CARD IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
P960009|S025|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA AND ITREL II NEUROSTIMULATORS FOR DEEP BRAIN STIMULATION (DBS) SOFTWARE|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2002|10/31/2002|||APPR|APPROVAL FOR THE MODEL 8870 N'VISION APPLICATION CARD.  THE MODEL 8870 N'VISION APPLICATION CARD IS AN ACCESSORY TO THE SOLETRA AND ITREL II NEUROSTIMULATORS FOR DBS.
P810025|S021|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2002|12/03/2002|||APPR|APPROVAL FOR A BUFFERED FORMULATION (PH 6.8 - 7.6) FOR AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS.
P990075|S008|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2002|06/07/2002|||OK30|CHANGE OF SUPPLIER FOR MOLDED SILICONE COMPONENTS TO PORGES, DIVISION OF MENTOR, SARLAT SEDEX, FRANCE AND A CHANGE IN SUPPLIER OF THE RAW MATERIAL FROM DOW CORNING TO NUSIL FOR ONE MOLDED COMPONENT.
P990066|S013|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2002|06/05/2002|||OK30|ADDITION OF A SIEMENS MODEL 6GF6300-1BW04 AWS MONITOR WITH PDS CRT AS AN ALTERNATIVE SUPPLIER OF THE AWS MONITOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM AND SUPPRESSION OF THE AWS MONITOR CALIBRATION TEST.
P890003|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/13/2002|06/12/2002|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9896 SOFTWARE FOR USE WITH THE MEDTRONIC MODEL 2090 PROGRAMMER SERIES FOR USE IN PROGRAMMING THE JEWEL MODEL 7218.
P010032|S002|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS XP & GENESIS DUAL XP NEUROSTIMULATION SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2002|07/16/2002|||APPR|APPROVAL FOR THE GENESIS XP NEUROSTIMULATION SYSTEM AND GENESIS XP DUAL NEUROSTIMULATION SYSTEM WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P850079|S040|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS)|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/2002|06/13/2002|||APPR|APPROVAL FOR EXTENDED WEAR APPROVAL FOR THE FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES WITH UV ABSORBING MONOMER.  THESE DEVICES, PREVIOUSLY CLEARED FOR DAILY WEAR UNDER K020392, WILL BE MARKETED UNDER THE TRADE NAMES LISTED BELOW FOR THE FOLLOWING INDICATIONS FOR USE:FREQUENCY 55 UV AND FREQUENCY 55 UV ASPHERIC LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THEY ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NOT APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  FREQUENCY 55 UV TORIC LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THEY ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA, AND ASTIGMATISM) IN APHAKIC AND NOT APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENSES MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 12.00 DIOPTERS OR LESS.  FREQUENCY 55 UV MULTIFOCAL LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THEY ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES WITH MYOPIA OR HYPEROPIA AND ARE PRESBYOPIC.  THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION INTO THE CORNEA AND THE EYE.  NOTE:  ONLY CHEMICAL (NOT HEAT) AND HYDROGEN PEROXIDE DISINFECTION SYSTEMS MAY BE USED WITH FREQUENCY 55 UV LENSES.  FREQUENT/PLANNED REPLACEMENT  WHEN PRESCRIBED FOR...
P920031|S003|DADE BEHRING, INC.|PO BOX 6101||NEWARK|DE|19714|6101|CYCLOSPORINE|COBAS INTEGRA 400 PLUS CYCLOSPORINE|MKW|TX|Normal 180 Day Track||N|05/17/2002|07/24/2002|||APPR|APPROVAL FOR EXPANDING THE USE OF THE COBAS INTEGRA CYCLOSPORINE REAGENT TO THE COBAS INTEGRA 400 PLUS ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS INTEGRA CYCLOSPORINE AND IS INDICATED FOR QUANTITATIVE DETERMINATION OF CYCLOSPORINE IN WHOLE BLOOD AS AN AID IN THE MANAGEMENT OF CYCLOSPORINE THERAPY IN KIDNEY, HEART AND LIVER TRANSPLANT PATIENTS.
P000049|S004|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIKLOAD|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2002|06/19/2002|||OK30|CHANGE TO THE INCOMING INSPECTION FOR TYVEK/MYLAR POUCHES USED FOR PACKAGING THE IMPLANT AND DELIVERY SYSTEM.
P900056|S072|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2002|06/27/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION CORK, LTD. (BSCL), CORK, IRELAND, AS THE MANUFACTURING FACILITY FOR THE MOLDED SHUTTLE SEAL AND LIP SEAL COMPONENTS OF THE ROTABLATOR DEVICES.
P840001|S062|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM|LGW|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2002|07/25/2002|||APPR|APPROVAL FOR THE MODEL 3550-16 EZ ANCHOR ACCESSORY KIT WHICH WILL BE LABELED FOR USE WITH THE FOLLOWING MEDTRONIC, INC. LEADS: PISCES-QUAD MODEL 3487A, RESUME MODEL 3587A, TEMPORARY SCREENING LEAD MODEL 3861, PISCES-QUAD COMPACT MODEL 3887, PISCES-QUAD PLUS MODEL 3888 AND THE PISCES-OCTAD MODEL 3898.  THE MODEL 3550-16 EZ ANCHOR IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
P000043|S003|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|Normal 180 Day Track|Express GMP Supplement|N|05/20/2002|06/25/2002|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT TRICOR SYSTEMS, INC., ELGIN , ILLINOIS.  THE TMX-2000 CONTROL SYSTEM WILL BE MANUFACTURED AT THIS FACILITY.
P000046|S004|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2002|12/03/2002|||APPR|APPROVAL FOR A BUFFERED FORMULATION (PH 6.8 - 7.6) FOR STAARVISC II, SHELLGEL, AND COEASE VISCOELASTICS.
P900043|S040|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY BALLOON EXPANDABLE STENT WITH RAPTOR OTW DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTOR OTW|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2002|05/31/2002|||OK30|MODIFICATION IN THE STENT CRIMPING PROCESS.
P950020|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/22/2002|07/17/2002|||APPR|APPROVAL FOR THE 6 MM CUTTING BALLOON.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL/OTW (6 MM) AND IS INDICATED FOR DILATATION OF STENOSIS IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.  IN ADDITION, THE TARGET LESION SHOULD POSSESS THE FOLLOWING CHARACTERISTICS: DISCRETE (<= 15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH); WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.0 MM TO 4.0 MM; READILY ACCESSIBLE TO THE DEVICE; LIGHT TO MODERATE TORTUOSITY OF PROXIMAL VESSEL SEGMENT, NON-ANGULATED LESION SEGMENT (<45 DEGREES), SMOOTH ANGIOGRAPHIC CONTOUR; AND ABSENCE OF ANGIOGRAPHICALLY-VISIBLE THROMBUS AND/OR CALCIFICATION.
P840001|S063|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, SYNERGY AND SYNDERGY VERSITREL NEUROSTIMULATORS|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/22/2002|06/12/2002|||APPR|APPROVAL FOR UPDATING THE MAGNETIC RESONANCE IMAGING (MRI) TEXT IN THE SPINAL CORD STIMULATION PAIN THERAPY MANUALS.
P970053|S007|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/23/2002|10/28/2002|||APPR|APPROVAL FOR THE ADDITION OF A WINDOWS OPERATING SYSTEM AND EYE TRACKING SYSTEM TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM.
P010002|S001|COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES|150 GLOVER AVE.||NORWALK|CT|06856||Tissue adhesive for the topical approximation of skin|INDERMIL TISSUE ADHESIVE|MPN|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/24/2002|06/20/2002|||APPR|APPROVAL FOR LABELING CHANGES TO INCLUDE AN EXTENSION TO THE LABELED DEVICE SHELF-LIFE FROM 12 MONTHS TO 24 MONTHS AND A 4-WEEK AMBIENT STORAGE CLAIM.
P960058|S021|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION MULTI STRATEGY COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/28/2002|06/06/2002|||APPR|APPROVAL FOR THE CPI SWITCH BOX (FORMERLY A/B SWITCH BOX).  THE CPI SWITCH BOX IS AN INTERFACE BOX TO FACILITATE THE CONNECTION OF TWO PROGRAMMING CABLES TO THE EXISTING CPI (CLINICIAN'S PROGRAMMING INTERFACE).
P940022|S021|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|BTE (BEHIND-THE-EAR) SYSTEM SENSOR (ADULT)|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/28/2002|06/06/2002|||APPR|APPROVAL FOR THE BTE SYSTEM SENSOR, AN ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR FOR LIMITED VERIFICATION OF SYSTEM FUNCTIONALITY.
P960058|S022|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC)|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/28/2002|06/06/2002|||APPR|APPROVAL FOR THE BTE SYSTEM SENSOR, AN ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR FOR LIMITED VERIFICATION OF SYSTEM FUNCTIONALITY.
P940022|S022|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CPI SWITCH BOX|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/28/2002|06/06/2002|||APPR|APPROVAL FOR THE CPI SWITCH BOX (FORMERLY A/B SWITCH BOX).  THE CPI SWITCH BOX IS AN INTERFACE BOX TO FACILITATE THE CONNECTION OF TWO PROGRAMMING CABLES TO THE EXISTING CPI (CLINICIAN'S PROGRAMMING INTERFACE).
P010002|S002|COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES|150 GLOVER AVE.||NORWALK|CT|06856||Tissue adhesive for the topical approximation of skin|INDERMIL TISSUE ADHESIVE|MPN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/28/2002|||OK30|PACKAGING CHANGE FROM A 5 AND 20 UNIT DOSE CONFIGURATION TO A NEW 12 AND 24 UNIT DOSE CONFIGURATION.  THE PACKAGING CHANGES WILL MAKE GREATER USE OF THE SPACE WITHIN THE PACKAGING AND ALLOW MORE UNITS TO BE SHIPPED IN THE SAME OR SLIGHTLY INCREASED VOLUME PACKAGING.
P860019|S184|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/25/2002|||OK30|ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
P880027|S062|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/25/2002|||OK30|ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
P880065|S007|Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||PULSE-GENERATOR, PROGRAM MODULE|AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER|LOT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/25/2002|||OK30|ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
P930031|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TRANSJUGLAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/25/2002|||OK30|ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
P940019|S012|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ILLIAC ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/25/2002|||OK30|ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
P970061|S015|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|RADIUS CORONARY STENT WITH DELIVERY SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/25/2002|||OK30|ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
P980001|S040|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760||STENT, CORONARY|NIR PREMOUNTED STENT DELIVERY SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/25/2002|||OK30|ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
P980033|S003|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2002|06/25/2002|||OK30|ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
P900056|S073|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2002|06/26/2002|||OK30|CHANGE IN THE BURR ADHESION PROCESS.
P900061|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2002|06/12/2002|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9896 SOFTWARE FOR USE WITH THE MEDTRONIC MODEL 2090 PROGRAMMER SERIES FOR USE IN PROGRAMMING THE JEWEL MODEL 7218.
P980015|S005|INNOVATIVE MEDICAL SYSTEMS, INC.|3610 OAKDALE DRIVE||MOUNTAIN BROOK|AL|35223||Device, needle destruction|SHARPX NEEDLE DESTRUCTION UNIT|MTV|HO|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/2002|06/12/2002|||APPR|APPROVAL FOR THE EXPANSION OF THE NEEDLE GAUGE RANGE TO INCLUDE 18-30 GAUGE NEEDLES, AND MINOR LABELING CHANGES.
P990020|S009|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/2002|11/21/2002|||APPR|APPROVAL FOR THE XPEDIENT DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANEURX STENT GRAFT WITH EXPEDIENT DELIVERY SYSTEM AND IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING:  1) INFRARENAL, NON-ANEURYSMAL, NECK LENGTH OF GREATER THAN 1 CM AT THE PROXIMAL AND DISTAL ENDS OF THE ANEURYSM AND AN INNER VESSEL DIAMETER APPROXIMATELY 10-20% SMALLER THAN THE LABELED DEVICE DIAMETER:  2) MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR;  3) ONE OF THE FOLLOWING: A) ANEURYSM DIAMETER > 5 CM;  B) ANEURYSM DIAMETER OF 4-5 CM WHICH HAS ALSO INCREASED IN SIZE BY 0.5 CM IN THE LAST 6 MONTHS; OR  C) ANEURYSM WHICH IS TWICE THE DIAMETER OF THE NORMAL INFRARENAL AORTA.
P900056|S074|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM             WIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2002|06/28/2002|||OK30|ALTERNATE MANUFACTURING PROCESS TO THE ELECTROPLATING PROCESS FOR THE ROTABLATOR SYSTEM FLOPPY GOLD GUIDE WIRE.
P990066|S014|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/2002|06/13/2002|||APPR|APPROVAL FOR THE ADDITION OF GRME AS AN ALTERNATIVE SUPPLIER OF THE GENERATOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM.
P990009|S012|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX HEMOSTATIC SEALANT DEVICE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2002|06/28/2002|||OK30|CONVERT TO CLEANROOM AND CONTROLLED ENVIRONMENT STANDARD ISO 14644-1:1999.
P980023|S009|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|KAINOX RV-S/ KAINOX VCS ICD LEADS|DTA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2002|11/25/2002|||APPR|APPROVAL FOR THE KAINOX RV-S ACTIVE FIXATION, SINGLE SHOCK COIL ICD LEAD AND THE KAINOX VCS SINGLE SHOCK COIL ICD LEAD FOR USE AS AN ADJUNCT TO MODIFY THE SHOCK CONFIGURATION OF ICD SYSTEMS.  TOGETHER WITH LEGALLY MARKETED BIOTRONIK ICDS, THESE LEAD SYSTEMS PROVIDE THE PATIENT WITH A SYSTEM THAT IS CAPABLE OF DETECTING AND TREATING VENTRICULAR TACHYARRHYTHMIAS.
P860019|S185|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|BOSTON SCIENTIFIC/SCIMED PTCA/PERFUSION CATHETERS|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/05/2002|06/25/2002|||APPR|APPROVAL FOR THE INCLUSION OF A TABLE SPECIFYING THE RECOMMENDED MINIMUM GUIDING CATHETER INNER DIAMETER IN THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING PTCA CATHETER MODELS:  NC MONORAIL, NC RANGER 15 MM, NC RANGER 22/25/30 MM, NC RANGER 16/18 MM AND NC RANGER 9 MM.
P980022|S009|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Express GMP Supplement|N|06/06/2002|06/25/2002|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT MEDTRONIC MIMIMED, NORTHRIDGE, CALIFORNIA.
P960036|S006|IOLTECH, S.A.|64 SCHOOSETT STREET||PENBROKE|MA|02359|1882|intraocular lens|CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/06/2002|06/20/2002|||APPR|APPROVAL FOR A TRADE NAME CHANGE OF THE MEMORYLENS IOL.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE OF OLDER WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY AN EXTRACAPSULAR CATARACT EXTRACTION METHOD.  THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
P000018|S022|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE/BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2002|06/28/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO ELIMINATE AN INSPECTION TEST.
P010012|S002|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/07/2002|12/20/2002|||APPR|APPROVAL FOR THE COMMERCIAL INTRODUCTION OF THE CONTAK RENEWAL MODEL H135 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE MODEL 2845 VERSION 1.7 SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTAK RENEWAL AND IS INDICATED AS FOLLOWS:  THE CONTAK RENEWAL HEART FAILURE DEVICE SYSTEM IS INDICATED FOR USE IN THE FOLLOWING:  PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <35%) AND QRS DURING >120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY.  PATIENT POPULATIONS AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS INCLUDE, BUT ARE NOT LIMITED TO, THOSE WITH:  1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA.  2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).  NOTE: THE CLINICAL OUTCOME OF HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS IS NOT FULLY KNOWN.  SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.  3) PRIOR MYOCARDIAL INFARCTION, LEFT VENTRICULAR EJECTION FRACTION OF <35%, AND A DOCUMENTED EPISODE OF NONSUSTAINED VT, WITH AN INDUCIBLE VENTRICULAR TACHYARRHYTHMIA.  4) PATIENTS SUPPRESSIBLE WITH IV PROCAINAMIDE OR AN EQUIVALENT ANTIARRHYTHMIC (DRUG) HAVE NOT BEEN STUDIED.
P940016|S009|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM|MMY|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2002|09/20/2002|||APPR|APPROVAL FOR  1) THE TRANSFER OF THE STERILIZATION PROCESS FOR THE BLOOD TUBING LINE COMPONENT OF B. BRAUN MEDICAL, INC.'S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM FROM ITS CURRENT, PMA APPROVED LOCATION TO THE B. BRAUN CAREX S.P.A. FACILITY; AND  2) THE PROPOSAL TO STERILIZE THE BLOOD TUBING LINES USING 10 PERCENT ETHYLENE OXIDE (ETO) AND 90 PERCENT CARBON DIOXIDE (CO2).
P990036|S003|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014||Intravascular radiation delivery system|CORDIS CHECKMATE SYSTEM|MOU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/10/2002|07/25/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE REGARDING THE RECOILING OF THE SOURCE RIBBON ON THE SPOOL OF THE DELIVERY DEVICE AND THE USE OF THE METAL CAPS ON THE ENDS OF THE DELIVERY DEVICE.
P990017|S032|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Express GMP Supplement|N|06/10/2002|07/25/2002|||APPR|APPROVAL FOR THE TRANSFER OF THE JACKET SUBASSEMBLY AND PARTS WASHING TO GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
P950005|S015|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER|DRF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2002|11/13/2002|||APPR|APPROVAL FOR THE STERILIZATION FACILITY LOCATED AT COSMED OF CALIFORNIA, SAN DIEGO, CALIFORNIA.
P980012|S003|WORLD HEART, INC.|7799 PARDEE LN.||OAKLAND|CA|94621||Ventricular (assisst) bypass|NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/2002|01/10/2003|||APPR|APPROVAL FOR OPTIONAL USE OF THE RE-DESIGNED EPTFE INFLOW CONDUIT WITH THE NOVACOR N100PC LVAS DEVICE SYSTEM.
P900060|S024|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/2002|12/10/2002|||APPR|APPROVAL TO COMBINE THE CARBOMEDICS PROSTHETIC HEART VALVE (CPHV; APPROVED ON SEPTEMBER 29, 1993 UNDER P900060) WITH THE SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS (CLEARED ON JUNE 13, 2002 UNDER K013022).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS, MODEL CP-(SIZE), WILL BE AVAILABLE IN SIZES 21, 23, 25, 27, 29, 31, AND 33 MM, AND IS INDICATED FOR USE IN OPEN HEART SURGERY FOR SIMULTANEOUS REPLACEMENT OF THE ASCENDING AORTA AND THE AORTIC VALVE IN CASES OF ANEURYSM, DISSECTION, OR OTHER DISEASE CONDITIONS OF THE AORTA COMBINED WITH DISEASE OR DEGENERATION OF THE AORTIC VALVE.
P990025|S006|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS|DRF|CV|Real-Time Process|Other Report|N|06/07/2002|04/22/2003|||APPR|APPROVAL FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS (FROM CONVENTIONAL ETHYLENE OXIDE PROCESSING TO EO EXPRESS).
P950005|S016|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS|DRF|CV|Real-Time Process|Other Report|N|06/07/2002|04/22/2003|||APPR|APPROVAL FOR CHANGES IN THE STERILIZATION CYCLE PARAMETERS.
P940010|S010|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)|MVG|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/2002|08/01/2003|||APPR|APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE ADDITIONAL INDICATION FOR USE FOR THE ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.
P990021|S001|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, PHOTODYNAMIC THERAPY|DIOMED 630 PDT LASER|MVF|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/2002|08/01/2003|||APPR|APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE ADDITIONAL INDICATION FOR USE FOR THE ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.
P950032|S032|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/12/2002|07/02/2002|||APPR|APPROVAL TO INTRODUCE A NEW CELL STRAIN INTO THE PRODUCTION OF APLIGRAF (I.E., HEP 012).
P970051|S020|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH STYLET REPLACEMENT TOOL|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/2002|06/20/2002|||APPR|APPROVAL FOR A STYLET REPLACEMENT TOOL.
P850035|S029|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|MODEL SPF-60 SPINAL FUSION STIMULATOR|LOE|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/13/2002|12/06/2002|||APPR|APPROVAL FOR THE MODEL SPF-60 IMPLANTABLE SPINAL FUSION STIMULATOR AND IS INDICATED FOR USE AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS.
P930021|S006|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN GEL|NQA|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/17/2002|03/28/2003|||APPR|APPROVAL FOR EXTENSION OF THE EXPIRATION DATE ON EMDOGAIN GEL FROM 18 MONTHS TO 24 MONTHS.
P000023|S001|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM|LZD|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/2002|09/12/2002|||APPR|APPROVAL FOR THE "SURGEON'S MANUAL."
P000035|S001|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM|MPI|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/2002|09/12/2002|||APPR|APPROVAL FOR THE "SURGEON'S MANUAL."
P980041|S001|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/2002|10/01/2002|||APPR|APPROVAL FOR EXPANDING THE USE OF THE AFP IMMUNOASSAY ON THE ACCESS 2 ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME ACCESS AFP IMMUNOASSAY SYSTEM AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN:  1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER.  2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO 20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD).  TEST RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD.  THE ASSAY IS INTENDED FOR USED IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY.
P990074|S011|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/17/2002|09/04/2002|||APPR|APPROVAL FOR REVISED LABELING THAT REFLECTS 5-YEAR POST-APPROVAL STUDY DATA.
P000023|S002|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM|LZD|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/20/2002|09/12/2002|||APPR|APPROVAL FOR THE "CRYSTAL CLEAR ANATOMICAL MODEL PACKAGE INSERT."
P000035|S002|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM|MPI|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/20/2002|09/12/2002|||APPR|APPROVAL FOR THE "CRYSTAL CLEAR ANATOMICAL MODEL PACKAGE INSERT."
P000023|S003|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA EMINENCE PROSTHESIS SYSTEM|LZD|DE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2002|01/22/2004|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE FOR THE CRYSTALCLEAR ANATOMICAL MODEL.  THE SITE IS LOCATED AT TMJ IMPLANTS, INC., GOLDEN, COLORADO.
P000035|S003|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM|MPI|DE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2002|01/22/2004|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE FOR THE CRYSTALCLEAR ANATOMICAL MODEL.  THE SITE IS LOCATED AT TMJ IMPLANTS, INC., GOLDEN, COLORADO.
P970008|S021|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/2002|04/01/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE MICROWAVE DELIVERY SYSTEM (REFERRED TO AS THE "COOLED THERMOCATH") AND ASSOCIATED CHANGES TO THE TREATMENT PARAMETERS.
P890055|S015|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|IMPLANTABLE INFUSION PUMPS|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/2002|09/24/2002|||APPR|APPROVAL FOR A CHANGE TO THE LABELING TO ADD A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY STATEMENT.  ONE LABEL IS A MRI DATA CHART AND ONE LABEL IS A TECHNICAL REPORT DESCRIBING THE EFFECTS OF MRI ON THE DEVICE.
P840001|S064|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/2002|09/26/2002|||APPR|APPROVAL FOR THE MODEL 3890 PISCES Z QUAD LEAD, MODEL 3891 PISCES Z QUAD COMPACT LEAD, MODEL 3892 PISCES Z QUAD PLUS LEAD AND MODEL 3550-22 AND 3550-23 LEAD REVISION KITS.  THE DEVICES ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
P990026|S013|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2002|07/25/2002|||OK30|CHANGE IN THE GLUCOPAD ASSEMBLY PROCESS IN THE AUTOSENSOR ASSEMBLY SEQUENCE TO INCREASE THE EFFICIENCY OF THE PROCESS.
P990017|S034|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOCRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2002|07/24/2002|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR THE ANCURE ENDOGRAFT SYSTEM TO ADD AN INSPECTION STEP IN ONE MANUFACTURING PROCEDURE FOR THE CONTRALATERAL PULLWIRE.
P960052|S005|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND TOPICAL SKIN ADHESIVE|MPN|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2002|07/24/2002|||APPR|APPROVAL FOR A CHANGE IN INDICATIONS TO CLARIFY THE USE OF THE DEVICE.
P970035|S040|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MODELS S7, S670 AND S660 DISCRETE TECHNOLOGY OVER-THE-WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2002|07/24/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF APPLYING THE MARKER BANDS ON THE PROXIMAL TUBING.
P950020|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/2002|03/11/2003|||APPR|APPROVAL FOR:  1) USE OF THE BIOSLIDE COATING ON ALL CUTTING BALLOON MODELS, AND  2) USE OF A REVISED Y-SITE ON OVER-THE-WIRE (OTW) CUTTING BALLOON MODELS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL/OTW AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.  IN ADDITION, THE TARGET LESION SHOULD POSSES THE FOLLOWING CHARACTERISTICS: DISCRETE (<= 15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH); WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.0 MM TO 4.0 MM; READILY ACCESSIBLE TO THE DEVICE; LIGHT TO MODERATE TORTUOSITY OF PROXIMAL VESSEL SEGMENT, NON-ANGULATED LESION SEGMENT (< 45 DEGREES), SMOOTH ANGIOGRAPHIC CONTOUR; AND ABSENCE OF ANGIOGRAPHICALLY-VISIBLE THROMBUS AND/OR CALCIFICATION.
P980016|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/2002|12/17/2002|||APPR|APPROVAL FOR MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS WITH MODEL 9967 (MARQUIS VR) APPLICATION SOFTWARE FOR USE WITH THE COMMERCIALLY AVAILABLE MODEL 9322 PATIENT MAGNET, THE MODEL 9790C PROGRAMMING SYSTEM [9790C PROGRAMMER, MODEL 9990 DESKTOP SOFTWARE AND MODEL 9767/9767L TELEMETRY PROGRAMMING HEAD (TELEMETRY B)] AND WITH THE MODEL 2090 PROGRAMMING SYSTEM [2090 PROGRAMMER, MODEL 9986 DESKTOP SOFTWARE AND MODEL 2067/2067L TELEMETRY PROGRAMMING HEAD (TELEMETRY PROGRAMMING HEAD (TELEMETRY B)].  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P930021|S007|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN GEL|NQA|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2002|05/20/2003|||APPR|APPROVAL OF THE ADDITIONAL INDICATIONS FOR USE AS AN ADJUNCT TO PERIODONTAL SURGERY FOR MANDIBULAR CLASS II FURCATIONS WITH MINIMAL INTERPROXIMAL BONE LOSS.
P000052|S009|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS|MOU|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2002|12/10/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE CARTRIDGE SHIPPING CONTAINER AND THE ADDITION OF AN ELECTROSTATIC DISCHARGE WARNING LABEL ON THE CARTRIDGE.
P900023|S037|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2002|04/28/2003|||APPR|APPROVAL FOR THE ADDITION OF THE AB5000 PNEUMATIC DRIVE CONSOLE TO THE BVS 5000 DEVICE SYSTEM.  THE AB5000 CONSOLE CAN BE USED TO DRIVE ONE OR TWO BVS 5000 BLOOD PUMPS; IT CAN BE USED EITHER IN THE HOSPITAL OR FOR TRANSPORT OF PATIENTS BETWEEN HOSPITALS.
P920023|S015|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY|MES|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/01/2002|07/22/2004|||APPR|APPROVAL TO CONCLUDE THE BENIGN PROSTATIC HYPERTROPHY PORTION OF THE UROLUME POST-APPROVAL STUDY AND TO INCLUDE THE PROBABILITY OF EXPLANT DUE TO TISSUE RESPONSE AT 10 YEARS IN THE LABELING.
P010015|S007|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD|LWP|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|06/28/2002|12/23/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P010032|S003|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2002|09/18/2002|||APPR|APPROVAL FOR THE MODEL 3811 PAINDOC COMPUTERIZED SUPPORT SYSTEM, VERSION 2.01 FOR USE WITH THE GENESIS MODEL 3850 PATIENT PROGRAMMER WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK  AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P970018|S004|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/02/2002|10/01/2002|||APPR|APPROVAL FOR STOPPING THE POST-APPROVAL REPORTING REQUIREMENT FOR A DIRECT-TO-VIAL STUDY FOR THE PREPSTAIN SYSTEM.
P970042|S003|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotripter, shockwave (for treating gallbladder stones)|MEDSTONE STS-TC/U LITHOTRIPTER|NCV|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/03/2002|02/14/2003|||APPR|APPROVAL FOR THE STS-TC/U LITHOTRIPTER (TRANSPORTABLE VERSION OF THE STS LITHOTRIPTER WITH ULTRASOUND).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTONE STS-TC/U LITHOTRIPTER AND IS INDICATED FOR  1) THE FRAGMENTATION OF SYMPTOMATIC UPPER URINARY TRACT STONES, I.E., RENAL CALYCEAL STONES, RENAL PELVIC STONES, AND UPPER URETERAL STONES, AND  2) WHEN USED IN CONJUNCTION WITH CERTAIN URSODIOLS, IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (BETWEEN 4 AND 20 MM IN MAXIMUM DIAMETER) IN ADULT PATIENTS FOR WHOM SURGICAL REMOVAL OF THE GALLBLADDER IS MEDICALLY CONTRAINDICATED AND IN SYMPTOMATIC HIGH-RISK PATIENTS WHO HAVE ACTIVELY REFUSED SURGERY.  COMBINATION THERAPY CONSISTS OF 1) ADMINISTRATION OF NOVARTIS PHARMACEUTICAL ACTIGALL., OR AMIDE PHARMACEUTICAL URSODIOL, OR TEVA PHARMACEUTICAL URSODIOL (8-10 MG/KG/DAY) FOR AT LEAST TWO WEEKS PRE-LITHOTRIPSY,  2) LITHOTRIPSY TREATMENTS OF UP TO 2000 24 KV SHOCKS, AND  3) CONTINUED ADMINISTRATION OF URSODIOL UNTIL A STONE-FREE STATE IS ACHIEVED.
P000052|S010|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2002|08/02/2002|||OK30|AMENDING IMPLEMENTATION OF MANUFACTURING CHANGES DESCRIBED IN P000052/S007, APPROVED APRIL 17, 2002 AND ADDING A VERIFICATION STEP TO THE PREVENTIVE MAINTENANCE CHECKLIST FOR THE GALILEO SOURCE DELIVERY UNIT.
P960036|S007|IOLTECH, S.A.|64 SCHOOSETT STREET||PENBROKE|MA|02359|1882|intraocular lens|CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2002|07/26/2002|||OK30|ADDITION OF AN ALTERNATE STEAM STERILIZER FOR THE TERMINAL STERILIZATION OF THE CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS.
P990075|S009|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS.|FWM|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2002|09/03/2002|||APPR|APPROVAL FOR REVISED LABELING THAT REFLECTS 5-YEAR POST-APPROVAL STUDY DATA.
P000028|S001|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|AFFINITY ANTERIOR CERVICAL CAGE SYSTEM|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/09/2002|08/13/2002|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE DEVICE:  1) MINOR DESIGN CHANGES TO THE CAGE, MAINLY CONSISTING OF MINOR CHANGES TO THE THREADS;  2) PROVIDE THE DEVICE STERILE; AND  3) CHANGE THE DEVICE NAME TO THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFFINITY ANTERIOR CERVICAL CAGE SYSTEM AND IS INDICATED FOR ANTERIOR CERVICAL INTERBODY FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH CERVICAL DISC DISEASE AT ONE LEVEL FROM THE C2-C3 DISC TO THE C7-T1 DISC.  CERVICAL DISC DISEASE IS DEFINED AS INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY WITH HERNIATED DISC AND/OR OSTEOPHYTE FORMATION ON POSTERIOR VERTEBRAL ENDPLATES PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION CONFIRMED BY RADIOGRAPHIC STUDIES.  AFFINITY IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH.
P000005|S005|MEDITEAM AB|GOTEBORGSVAGEN 74,||SAVEDALEN||S-433|433|SOLUTION, REMOVAL, CARRIES|CARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM|LMW|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/2002|10/23/2002|||APPR|APPROVAL FOR A MODIFICATION TO THE FORMULATION OF CARISOLV.
P000020|S007|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER, STINGER M, STINGER S AND STINGER SM ABLATION CATHETERS WITH 8F/5MM DISTAL ELECTRODE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/10/2002|08/19/2002|||APPR|APPROVAL FOR THE LINE OF STINGER CATHETERS CONFIGURED WITH AN 8F/5MM DISTAL ELECTRODE.
P810031|S024|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON SODIUM HYALURONATE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2002|07/25/2002|||APPR|APPROVAL FOR MODIFICATION OF THE "PRECAUTION" SECTION OF THE PACKAGE INSERT TO INCLUDE THE FOLLOWING: "BEFORE INITIATING PHACOEMULSIFICA-TION, USE IRRIGATION/ ASPIRATION TO CREATE A FLUID-FILLED SPACE ABOVE THE LENS.  THIS REDUCES THE RISK OF INITIAL VISCO-OCCULSION OF THE PHACO TIP OR THE IRRIGATION LINE WHICH COULD CAUSE PHACO TIP HEATING."
P990042|S004|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS ASSAY|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2002|11/14/2002|||APPR|APPROVAL FOR USE OF ETI-AB-AUK PLUS ASSAY ON THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT.
P970008|S022|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2002|08/01/2002|||OK30|CHANGE OF SUPPLIER FOR THE FIBER OPTIC TEMPERATURE SENSOR PROBE COMPONENT FROM THE LUXTRON CORPORATION IN SANTA CLARA, CALIFORNIA TO THE UROLOGIX FACILITY AND A CHANGE IN THE USE OF AN ADHESIVE BONDING PROCESS TO AN ANNEALING PROCESS ON THE COOLANT BAG.
P950029|S016|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|TALENT II DUAL-SENSOR IMPLANTABLE CARDIAC PACEMAKERS, MODELS DR233 AND SR133|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2002|12/18/2002|||APPR|APPROVAL FOR THE ADDITION OF THE AUTOSENSING FEATURE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT II, MODELS DR233 AND SR133, AND IS INDICATED FOR RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY.  THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE:  1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD DEGREE AV BLOCK;  2) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK;  3) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS;  4) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS;  5) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES.THE MODEL DR233 IS ALSO INDICATED FOR DUAL-CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHOM MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.  DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE:  1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT;  2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.
P970058|S014|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER M1000 SYSTEM|MYN|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/15/2002|09/13/2002|||APPR|APPROVAL FOR A REVISION OF THE LABELING FOR THE DEVICE BASED ON NEW ANALYSIS OF THE ORIGINAL PMA CLINICAL DATA.
P960009|S026|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC MODEL 7482 DBS EXTENSION|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/15/2002|10/31/2002|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE APPROVED MODEL 7482 DBS EXTENSION; COMBINE LOW PROFILE DESIGN AND TECHNOLOGY WITH A LOW IMPEDANCE CONDUCTOR, CHANGE THE COATING USED ON THE OUTSIDE DIAMETER TO SILOXANE, ADD A NEW TORQUE WRENCH TO THE EXTENSION PACKAGE, AND ADD A NEW MODEL 3550-25 BOOTS ACCESSORY KIT.
P000028|S002|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|AFFINITY ANTERIOR CERVICAL CAGE SYSTEM|MAX|OR|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/15/2002|12/03/2002|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM.
P970051|S021|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 CONTOUR ADVANCE|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/2002|11/22/2002|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATION TO THE CONTOUR 24 COCHLEAR IMPLANT ELECTRODE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTOUR SOFTIP ELECTRODE.
P830037|S046|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|PHEMFILCON A|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/2002|09/04/2002|||APPR|APPROVAL FOR A LABELING MODIFICATION OF THE SECONDARY BOX CARTON TO INCLUDE THE CLAIM "IMPROVED COMFORT".
P950032|S033|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2002|08/12/2002|||OK30|ELIMINATION OF TWO MEDIA FEEDS OF APLIGRAF DURING MANUFACTURE.
P880086|S088|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/17/2002|07/30/2002|||APPR|APPROVAL FOR A DOWNSIZED VERSION OF THE PHOTON UDR/VR DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V235) AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P860019|S186|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2002|11/21/2002|||APPR|APPROVAL FOR A MODIFICATION OF THE LASER WELDING PROCESS FOR THE MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS.
P830045|S081|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/17/2002|07/30/2002|||APPR|APPROVAL FOR A DOWNSIZED VERSION OF THE PHOTON UDR/VR DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V235) AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P910023|S061|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/17/2002|07/30/2002|||APPR|APPROVAL FOR A DOWNSIZED VERSION OF THE PHOTON UDR/VR DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V235) AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P000018|S023|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE(TM) BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2002|07/31/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO IMPLEMENT A NEW PROCESS OF APPLYING THE O-RINGS TO THE PROPRIETARY CONNECTOR USING AN O-RING INSTALLATION TOOL.
P970061|S016|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|SCIMED RADIUS STENT AND DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2002|07/31/2002|||OK30|CHANGE TO USE AN ALTERNATE SPRAY WASHER METHOD FOR IN-PROCESS RADIUS STENT CLEANING.
P990027|S006|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION|LZS|OP|Panel Track|Change Design/Components/Specifications/Material|N|07/18/2002|10/10/2003|03M-0533|11/24/2003|APPR|APPROVAL FOR THE BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION.  THE DEVICE USES AN OPTICAL ZONE SIZE BETWEEN 6.0 MM AND 7.0 MM WITH A CONSTANT BLEND ZONE OF .875 MM, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK):  1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO -3.00 D AND MRSE <=7.50 D AT THE SPECTACLE PLANE;  2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO +=0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION;  AND 3) IN PATIENTS 21 YEARS OF AGE OR OLDER.
P980023|S010|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)|DTA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2002|08/30/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE PCMCIA SOFTWARE CARTRIDGE INCLUDING AN INCREASE IN MEMORY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U) AND IS INTENDED TO ALLOW INTERROGATION AND PROGRAMMING OF BIOTRONIK ICD'S AND PACEMAKERS.
P980041|S002|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2002|12/06/2002|||APPR|APPROVAL FOR EXPANDING THE USE OF THE AFP IMMUNOASSAY ON THE SYNCHRON LXI 725 SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME ACCESS AFP IMMUNOASSAY SYSTEM AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN:  1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER.  2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO 20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD).  TEST RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD.  THE ASSAY IS INTENDED FOR USE IN CONJUNCTION  WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY.
P990074|S012|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|MCGHAN SALINE-FILLED BREAST IMPLANT|FWM|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/2002|08/08/2002|||APPR|APPROVAL FOR  1) DESIGN MODIFICATIONS TO THE PATCH CONFIGURATION,  2) CHANGES TO THE PATCH VULCANIZATION PROCESS, AND  3) CHANGES TO THE VALVE VULCANIZATION PROCESS.
P000058|S001|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/23/2002|10/04/2002|||APPR|APPROVAL OF THE POST-APPROVAL CLINICAL STUDY FOR THE DEVICE.  THE POST-APPROVAL CLINICAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE JULY 2, 2002 APPROVAL ORDER FOR P000058.
P900043|S041|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/ON RAPTORRAIL STENT DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/2002|08/22/2002|||APPR|APPROVAL FOR A CHANGE TO THE "USED BY" DATING ON THE DEVICES.
P010012|S003|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EASYTRAK LEAD MODELS 4510, 4511, 4512 AND 4513 CORONARY VENOUS STEROID ELUTING SINGLE-ELECTRODE PACE/SENSE LEADS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/2002|01/22/2003|||APPR|APPROVAL FOR ADDING A POLYURETHANE SLEEVE OVER THE SILICONE INSULATION IN THE TERMINAL CONNECTOR AREA AND MINOR CHANGES TO IMPROVE LEAD MANUFACTURABILITY.
P960043|S041|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|THE PERCLOSE A-T (AUTO TIE) SMC DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/2002|08/21/2002|||APPR|APPROVAL FOR A DEVICE NAME CHANGE, COMPANY NAME CHANGE, AND LABELING CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PERCLOSE A-T (AUTO TIE) SUTURE MEDIATED CLOSURE (SMC) DEVICE AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS.  THE PERCLOSE A-T 6 FR. SMC SYSTEMS REDUCE THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS.
P010041|S001|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|07/25/2002|01/17/2003|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P940022|S023|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/2002|09/09/2002|||APPR|APPROVAL FOR THE COMMERCIAL DISTRIBUTION OF THE CLARION HIFOCUS ELECTRODE WITHOUT THE POSITIONER (MODEL AB-5100-11A) IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17-YEARS, 11-MONTHS OF AGE).  IT ALSO REQUESTED APPROVAL OF THE HIGH RESOLUTION SPEECH PROCESSING STRATEGY (HIRES SOFTWARE, MODEL NUMBER CI-6055) FOR BOTH PATIENT POPULATIONS.
P960058|S023|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION CII BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/2002|09/09/2002|||APPR|APPROVAL FOR THE COMMERCIAL DISTRIBUTION OF THE CLARION HIFOCUS ELECTRODE WITHOUT THE POSITIONER (MODEL AB-5100-11A) IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17-YEARS, 11-MONTHS OF AGE).  IT ALSO REQUESTED APPROVAL OF THE HIGH RESOLUTION SPEECH PROCESSING STRATEGY (HIRES SOFTWARE, MODEL NUMBER CI-6055) FOR BOTH PATIENT POPULATIONS.
P930016|S015|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2002|08/07/2002|||APPR|APPROVAL FOR THE ADDITION OF AN AUTO-CENTERING FUNCTION TO THE VISX STAR S4 ACTIVE TRAK EYE TRACKING SYSTEM THAT INCLUDES MINOR DESIGN AND LABELING CHANGES.
P970004|S023|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL                 STIMULATON DESKTOP SOFTWARE|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/2002|01/23/2003|||APPR|APPROVAL FOR THE MODEL 8870 INTERSTIM APPLICATION SOFTWARE TO OPERATING ON THE MODEL 8840 CLINICIAN PROGRAMMER, USE OF ENHANCED STIMULATION DESKTOP SOFTWARE, AN EXPANDED MEMORY CARD STORAGE, AND UPDATED LABELING.  THESE CHANGES ARE USED WITH THE MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY RETENTION AND THE SYMPTOMS OF OVERACTIVE BLADDER, INCLUDING URINARY URGE INCONTINENCE AND SIGNIFICANT SYMPTOMS OF URGENCY-FREQUENCY ALONE OR IN COMBINATION, IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
P990014|S002|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|HYDROVIEW IOL BLANK MATERIAL|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|08/01/2002|09/04/2002|||APPR|APPROVAL FOR THE TRANSFER OF THE LENS BLANK MATERIAL MANUFACTURING FACILITY TO BAUSCH & LOMB INC., WILMINGTON, MASSACHUSETTS.
P010012|S004|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/2002|10/07/2002|||APPR|APPROVAL FOR THE MODELS H115 AND H119 CONTAK CD 2 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D).  THE CONTAK CD 2 CRT-D SYSTEM IS INDICATED FOR PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <=35%) AND QRS DURATION >=120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY.  PATIENTS POPULATIONS AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS INCLUDE, BUT ARE NOT LIMITED TO THOSE WITH:  1) SURVIVAL  OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA.  2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).   NOTE: THE CLINICAL OUTCOME OF HYMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS IS NOT FULLY KNOWN.  SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.  3) PRIOR MYOCARDIAL INFARCTION, LEFT VENTRICULAR EJECTION FRACTION OF <=35%, AND A DOCUMENTED EPISODE OF NONSUSTAINED, VT, WITH AN INDUCIBLE VENTRICULAR TACHY-ARRHYTHMIA.  PATIENTS SUPPRESSIBLE WITH IV PROCAINAMIDE OR AN EQUIVALENT ANTIARRHYTHMIC (DRUG) HAVE NOT BEEN STUDIED.
P960040|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 2844 APPLICATION SOFTWARE, VERSION 3.5|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/2002|10/07/2002|||APPR|APPROVAL FOR MODEL 2844 SOFTWARE, VERSION 3.5.
P840001|S065|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/01/2002|10/03/2002|||APPR|APPROVAL FOR THE MODEL 3898 PISCES-OCTAD LEAD AND THE MODEL 7471 OCTAPOLAR EXTENSION WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
P000043|S004|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/02/2002|08/22/2002|||APPR|APPROVAL TO REMOVE THE CONTRAINDICATION FOR PATIENTS WITH PROSTATIC OR BLADDER CANCER, AND ADD THE PRECAUTION STATING THAT THE SAFETY AND EFFECTIVENESS OF THE THERMATRX TMX-2000 HAS NOT BEEN ESTABLISHED IN PATIENTS WITH CLINICAL OR HISTOLOGICAL EVIDENCE OF PROSTATE OR BLADDER CANCER.
P970042|S004|MEDSTONE INTL., INC.|100 COLUMBIA, SUITE 100||ALISO VIEJO|CA|92656|4114|Lithotripter, shockwave (for treating gallbladder stones)|MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES|NCV|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|08/02/2002|01/28/2003|||APPR|APPROVAL FOR  1) A CHANGE IN THE INCLUSION AGE LIMIT FOR THE POST-APPROVAL STUDY FROM 18-70 TO 18 AND OVER;  2) A CHANGE IN THE POST APPROVAL STUDY'S MONITORING FROM RSI TO MEDSTONE; AND  3) A CHANGE IN THE POST-APPROVAL STUDY'S MEDICAL MONITOR FROM RSI TO MICHAEL ALBERT, M.D.
P880086|S089|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/02/2002|08/13/2002|||APPR|APPROVAL FOR THE MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND THE MODEL 3160 ECG ADAPTER CABLE.
P830045|S082|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/02/2002|08/13/2002|||APPR|APPROVAL FOR THE MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND THE MODEL 3160 ECG ADAPTER CABLE.
P910023|S062|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/02/2002|08/13/2002|||APPR|APPROVAL FOR THE MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND THE MODEL 3160 ECG ADAPTER CABLE.
P970035|S041|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/05/2002|12/06/2002|||APPR|APPROVAL TO MODIFY THE LABELING FOR THE MEDTRONIC AVE S660, S670 & S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS TO REFLECT A MINIMUM GUIDE CATHETER INNER DIAMETER OF 0.056".
P010034|S002|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY|MYN|RA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2002|03/07/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, INC., BOULDER, COLORADO.
P950032|S034|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2002|10/15/2002|||APPR|APPROVAL FOR THE INTRODUCTION OF A SODIUM HYDROXIDE STEP INTO THE BOVINE COLLAGEN PRODUCTION METHOD AND THE DISCONTINUATION OF VIRAL TESTING ON INDIVIDUAL LOTS OF COLLAGEN.
P960040|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM AVT AICD SYSTEM|LWP|CV|Panel Track|Change Design/Components/Specifications/Material|N|08/05/2002|03/27/2003|05M-0435|10/31/2005|APPR|APPROVAL FOR THE VANTAK PRIZM AVT AICD SYSTEM.  THE DEVICE IS INDICATED FOR USE IN THE FOLLOWING: PATIENTS WHO ARE ICD INDICATED AND WHO HAVE ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE:  1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR  2) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <=30% (AS DEFINED IN THE MADIT II CLINICAL STUDY APPENDIX).
P920047|S017|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/2002|09/27/2002|||APPR|APPROVAL FOR REVISED INDICATIONS FOR USE FOR THE STEEROCATH-T, POLARIS-T, AND BLAZER II ABLATION CATHETERS, WHICH ARE COMPONENTS OF THE EPT-1000 CARDIAC ABLATION SYSTEM.  THE CATHETERS ARE INDICATED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIA.
P000006|S002|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|MENTOR TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/2002|01/14/2003|||APPR|APPROVAL FOR REPROCESSING FINAL, STERILIZED ALPHA I INFLATABLE PENILE PROSTHESES TO INCORPORATE THE HYDROPHILIC COATING THAT WAS PREVIOUSLY APPROVED FOR USE ON NEWLY MANUFACTURED PROSTHESES IN SUPPLEMENT 1.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR TITAN INFLATABLE PENILE PROSTHESIS AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.
P960016|S008|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/08/2002|09/27/2002|||APPR|APPROVAL FOR REVISED INDICATIONS FOR USE FOR LIVEWIRE TC ABLATION CATHETERS.  THE CATHETERS ARE INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
P990026|S014|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/08/2002|08/23/2002|||APPR|APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE AUTOSENSOR FROM 6 MONTHS TO 18 MONTHS.
P010022|S001|ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Sealant,polymerizing|COSEAL SURGICAL SEALANT (PREMIXED)|NBE|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/09/2002|02/04/2003|||APPR|APPROVAL FOR:  1) CHANGE IN PACKAGING OF THE POLYMER RESINS TO A PRE-MIXED CONFIGURATION;  2) CHANGE IN BUFFER A TO A DILUTE HYDROGEN CHLORIDE SOLUTION WITH A PH OF 2.2;  3) CHANGE IN STERILIZATION TO GAMMA RADIATION; AND  4) CHANGE TO ROOM TEMPERATURE STORAGE.
P990074|S013|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/2002|08/23/2002|||APPR|APPROVAL FOR THE ADDITION OF  1) STYLES 68HP AND 68LP AND  2) CORRESPONDING PACKAGE LABELING.
P800012|S009|OSMED, INC.|325 LAKE AVE. SOUTH - SUITE|#608|DULUTH|MN|55802||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|DRILAC CUBES AND GRANULES|LPG|DE|Normal 180 Day Track|Express GMP Supplement|N|08/12/2002|09/17/2002|||APPR|APPROVAL FOR NEW MANUFACTURING AND STERILIZATION SITES.  THE MANUFACTURING SITE IS LOCATED AT KENSEY NASH CORPORATION, EXTON, PA.  THE NEW STERILIZATION SITE IS LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NJ.
P900066|S006|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY|LPO|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2002|12/10/2002|||APPR|APPROVAL TO ADD A MOLECULAR SIEVE SCRUBBING STEP AT THE END OF THE GAS MANUFACTURING PROCESS.
P990017|S035|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Express GMP Supplement|N|08/15/2002|09/10/2002|||APPR|APPROVAL FOR THE TRANSFER OF THE BALLOON CATHETER SUBASSEMBLY TO GUIDANT PUERTO RICO, DURADO, PUERTO RICO.
P870072|S020|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/2002|10/07/2002|||APPR|APPROVAL FOR A CHANGE IN THE SUPPLIER OF THE MICROPROCESSOR USED ON THE CONTROLLER BOARD IN THE TLC-II PORTABLE VAD DRIVER.
P850020|S016|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA COLUMN|LKN|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/16/2002|02/12/2003|||APPR|APPROVAL FOR AN EXTENSION TO THE PROSORBA COLUMN'S EXPIRATION DATE FROM 12 MONTHS TO 18 MONTHS.
P850048|S017|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2002|11/27/2002|||APPR|APPROVAL FOR THE ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER.  THE DEVICE IS INDICATED FOR:  THE ACCESS HYBRITECH PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ACCESS IMMUNOASSY SYSTEMS.  THE DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.  THE DEVICE IS FURTHER INDICATED FOR THE SERIAL MEASUREMENT OF PSA TO AID IN THE PROGNOSIS AND MANAGEMENT OF PATIENTS WITH PROSTATE CANCER.
P970038|S005|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2002|11/27/2002|||APPR|APPROVAL FOR THE ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER.  THE DEVICE IS INDICATED FOR:  THE ACCESS HYBRITECH FREE PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF FREE PROSTATE SPECIFIC ANTIGEN (FREE PSA) IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS.  ACCESS HYBRITECH FREE PSA IS INTENDED TO BE USED WITH HYBRITECH (TOTAL) PSA TO CALCULATE THE RATIO OF FREE PSA TO TOTAL PSA EXPRESSED AS A PERCENTAGE (PERCENT FREE PSA).  PERCENT FREE PSA AS MEASURED BY THE HYBRITECH ASSAYS IS INDICATED FOR USE AS AN  AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIONS, WHEN USED IN CONJUNCTION WITH HYBRITECH (TOTAL) PSA FOR PROSTATE CANCER DETECTION IN MEN AGED 50 YEARS AND OLDER WITH TOTAL PSA BETWEEN 4 AND 10 NG/ML WITH DIGITAL RECTAL EXAMINATION FINDINGS THAT ARE NOT SUSPICIOUS FOR CANCER.  PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.
P850079|S041|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Express GMP Supplement|N|08/20/2002|02/12/2003|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT COOPERVISION, INC., NORFOLK, VIRGINIA.
P000025|S004|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|08/20/2002|09/04/2002|||APPR|APPROVAL FOR THE MODIFICATION TO REPLACE COMBI 40+ COCHLEAR IMPLANT SYSTEM "INSERTION ELECTRODE" WITH THE INSERTION TEST DEVICE (ITD).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL INSERTION TEST DEVICE AND IS INDICATED FOR INDIVIDUALS UNDERGOING COCHLEAR IMPLANT SURGERIES AFTER A MASTOIDECTOMY, POSTERIOR TYMPANOTOMY, AND COCHLEOSTOMY HAVE BEEN PERFORMED AND WHERE ACCESS TO THE COCHLEA HAS BEEN SECURED.
P990081|S001|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY  HER 2 (CLONE CB11)|MVC|PA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2002|11/27/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT VENTANA MEDICAL SYSTEMS, TUCSON, ARIZONA.
P970035|S042|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MEDTRONIC AVE S660 ZIPPER MX CORONARY STENT SYSTEM            AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2002|10/02/2002|||APPR|APPROVAL FOR THE MEDTRONIC AVE S660 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM.
P990004|S004|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN POWDER|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2002|09/25/2002|||APPR|APPROVAL FOR MARKETING A POWDERED FORM OF THE ABSORBABLE GELATIN SPONGE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN POWDER (MADE FROM ABSORBABLE GELATIN SPONGE, USP) AND IS INDICATED FOR VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P990025|S007|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|Normal 180 Day Track|Express GMP Supplement|N|08/23/2002|09/10/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.
P990037|S011|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DIAGNOSTIC DUETT SEALING DEVICE, MODEL 2200; DIAGNOSTIC DUETT PRO SEALING DEVICE, MODEL 2210; AND D-STAT FLOWABLE HEMOS0|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2002|09/23/2002|||OK30|CHANGE IN THE ENDOTOXIN EXTRACTION PROCEDURE FOR TESTING THE SEALING AND HEMOSTASIS DEVICES.
P990026|S015|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH G2 BIOGRAPHER|CGA|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2002|09/23/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO FULLY AUTOMATE THE AUTOSENSOR ASSEMBLY PROCESS.
P970018|S005|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2002|10/27/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN BURLINGTON, NORTH CAROLINA.
P960009|S027|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/2002|12/16/2003|||APPR|APPROVAL FOR THE MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM WHICH INCLUDES THE MODEL 7428 KINETRA NEUROSTIMULATOR, MODEL 7436 ACCESS THERAPY CONTROLLER, MODEL 8840 N'VISION PROGRAMMER, MODEL 8870 SOFTWARE APPLICATION CARD, MODEL 7459 MEMORYMOD SOFTWARE CARTRIDGE, AND MODEL 3550-09 ACCESSORY KIT.  THESE ARE REVISIONS TO THE EXISTING MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY ALSO KNOWN AS THE ACTIVA SYSTEM.  THE MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM IS ONLY INDICATED FOR BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPA-RESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.  ADDITIONALLY, THIS SUPPLEMENT ALSO INCORPORATES THE LATEST MAGNETIC RESONANCE IMAGING (MRI) LABELING INFORMATION WITH RESPECT TO THE ABOVE SYSTEMS.
P010013|S003|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED EMDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2002|11/25/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT SANMINA-SCI CORPORATION, SAN JOSE, CALIFORNIA.  THE NOVACEPT RF CONTROLLER WILL BE MANUFACTURED AT THIS FACILITY.
P920047|S018|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER RPM CARDIAC ABLATION CATHETERS|LPB|CV|Normal 180 Day Track||N|08/28/2002|02/12/2003|||APPR|APPROVAL FOR THE BLAZER RPM CATHETER WHICH FEATURED MINOR DESIGN CHANGES (E.G., ADDITION OF THREE TRANSDUCER RINGS, LASER WELDED CENTER SUPPORT AND MULTIPLE COAXIAL DESIGN) TO THE BLAZER II CATHETER.
P950002|S011|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK VISTA INTERBODY FUSION DEVICE|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/2002|07/08/2003|||APPR|APPROVAL TO ADD THE BAK VISTA INTERBODY FUSION DEVICE, WHICH IS MANUFACTURED FROM 65% PEEK OPTIMA AND 35% TOHO BESFIGHT C6-UH CARBON FIBER, TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME BAK VISTA INTERBODY FUSION DEVICE AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L2-S1 SPINAL LEVELS.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S).  BAK DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR POSTERIOR APPROACH.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.  THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.
P890027|S052|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM/CHILDREN|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/2002|09/24/2002|||APPR|APPROVAL FOR PROPOSED LABELING CHANGES AS OUTLINED IN ATTACHMENT 3.
P840024|S083|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM/ADULTS|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/2002|09/24/2002|||APPR|APPROVAL FOR PROPOSED LABELING CHANGES AS OUTLINED IN ATTACHMENT 3.
P970051|S022|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/2002|09/24/2002|||APPR|APPROVAL FOR PROPOSED LABELING CHANGES AS OUTLINED IN ATTACHMENT 3.
P960007|S017|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE|MGR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/22/2002|06/28/2004|||APPR|APPROVAL FOR THE TERMINATION OF THE POST-APPROVAL STUDY PROTOCOL ENTITLE: "A RANDOMIZED, CONTROLLED WITHIN-PATIENT-PAIRED STUDY TO COMPARE THE EFFECTIVENESS OF TRANSCYTE AND BIOBRANE IN THE TREATMENT OF MID-DERMAL TO INDETERMINATE DEPTH BURN WOUNDS."
P000018|S024|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2002|09/30/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE NOVOSTE BETA-CATH SYSTEM SOURCE TRAIN GOLD MARKERS WHICH INVOLVES THE REMOVAL OF THE ELECTROLESS NICKEL FLASHING PROCESS.
P960040|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/03/2002|03/26/2003|||APPR|APPROVAL FOR THE ADDITION OF ATRIAL ARRHYTHMIA THERAPIES TO THE VITALITY AICD SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY AVT AND PROGRAMMER SOFTWARE APPLICATION MODEL 2812, AND IS INDICATED FOR USE IN THE FOLLOWING:  PATIENTS WHO ARE ICD INDICATED AND WHO HAVE ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE:  1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR  2) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <=30% (AS DEFINED IN THE MADIT II CLINICAL STUDY APPENDIX).
P900052|S011|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS|LNY|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2002|10/03/2002|||OK30|CHANGE IN THE METHOD OF MARKING THE PRODUCT NAME AND LOT NUMBER ON THE PORTAL RESERVOIRS FROM ENGRAVING TO LASER MARKING.
P990034|S003|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED IMPLANTABLE FLOW INFUSION PUMP|LKK|HO|Normal 180 Day Track|Express GMP Supplement|N|09/04/2002|11/08/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING, PACKAGING AND STERILIZATION FACILITY AT MEDTRONIC NEUROLOGICAL AND SPINAL DIVISION, COLUMBIA HEIGHTS, MINNESOTA.
P910001|S021|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|0.7 MM EXTREME CATHETER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/2002|02/04/2003|||APPR|APPROVAL FOR THE 0.7 MM SIZE OF THE EXTREME OTW X80 PERCUTANEOUS EXCIMER LASER CORONARY ANGIOPLASTY CATHETER.
P790027|S068|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Express GMP Supplement|N|08/30/2002|01/27/2003|||APPR|APPROVAL FOR A FACILITY CHANGE TO PRODUCE THE VIOLET COMPRESSION MOLDED (BCM) BLANK PMMA MATERIAL AT BAUSCH & LOMB, INC., WILMINGTON, MASSACHUSETTS.
P970043|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2002|11/07/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON, CORK, IRELAND.
P870072|S021|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/2002|05/14/2003|||APPR|APPROVAL FOR THE USE OF A REVERSE-ENGINEERED DIRECTIONAL FLOW VALVE, TO BE MANUFACTURED AT THE SITE LOCATED IN PLEASANTON, CALIFORNIA.
P800012|S010|OSMED, INC.|325 LAKE AVE. SOUTH - SUITE|#608|DULUTH|MN|55802||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|DRILAC CUBES AND GRANULES|LPG|DE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2002|10/09/2002|||APPR|APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE LABELING.
P000029|S001|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2002|09/23/2002|||OK30|CHANGE IN THE SITE FOR BACTERIAL ENDOTOXIN TESTING OF CERTAIN COMPONENTS USED IN DEFLUX INJECTABLE GEL, INTENDED FOR TREATMENT OF VESICOURETERAL REFLUX IN CHILDREN.
P820060|S015|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AXSYM AFP|LOJ|IM|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2002|09/12/2002|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
P900056|S075|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2002|09/30/2002|||OK30|CHANGE IN THE NUMBER OF AUDIT SAMPLES TAKEN FOR DESTRUCTIVE COMPRESSION TESTING ON THE UV BOND SUBASSEMBLY LINE.
P930014|S010|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOR SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL SA60AT ECTEDED DIOPTER RANGE|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/11/2002|10/07/2002|||APPR|APPROVAL TO EXTEND THE MODEL SA60AT POWER RANGE FROM +6.0D THROUGH +34.0D TO +6.0 THROUGH +40.0D.
P900039|S012|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT STRIP BONE GRAFT MATRIX|MBS|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2002|10/10/2002|||OK30|CHANGE IN THE DEFINITION OF A SAMPLE ITEM PORTION (SIP) FROM A STRIP ALONE TO A STRIP PLUS INNER PACKAGING (INNER TRAY, INNER TRAY LID, LIFT TAB, AND TRAY RETAINER).  ONLY A SINGLE SIP MAY BE SOURCED FROM EACH TRAY.
P930021|S008|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN GEL|NQA|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/2002|12/02/2003|||APPR|APPROVAL FOR THE ADDITION OF THE FOLLOWING INDICATION FOR USE:  "ENDOGAIN GEL IS INDICATED FOR USE IN CORONALLY POSITIONED FLAP PROCEDURES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS".  THE DEVICE, WITH THIS ADDITIONAL INDICATION FOR USE, WILL BE MARKETED UNDER THE TRADE NAME ENDOGAIN GEL.
P990020|S010|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/2002|12/23/2002|||APPR|APPROVAL FOR THE FORMAT TO BE USED FOR A CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIAN USERS AT LEAST ANNUALLY.  THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT.
P860004|S053|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED EL PROGRAMMABLE PUMP|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/2002|10/09/2002|||APPR|APPROVAL FOR CHANGES TO THE SYNCHROMED EL PROGRAMMABLE PUMP TECHNICAL MANUAL FOR NEW WARNINGS AND INFORMATION REGARDING INFLAMMATORY MASS, PUMP OVERPRESSURIZATION, DIATHERMY AND OTHER TEXT CHANGES.
P010031|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC INSYNC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODEL 7272|NIK|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|09/13/2002|10/25/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P840001|S066|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2002|10/29/2002|||APPR|APPROVAL FOR THE MODEL 7489 EXTENSION WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
P990080|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2002|09/24/2002|||APPR|APPROVAL FOR A NEW TRADE NAME FOR THE MODEL Z9000 FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS, AND OTHER LENS MODELS WHICH INCORPORATE THE MODIFIED PROLATE ANTERIOR OPTIC SURFACE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECHNIS, WITH Z-SHARP OPTIC TECHNOLOGY AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFI-CATION.  THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P960058|S024|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|BTE FIREFLY (PEDIATRIC)|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2002|09/23/2002|||APPR|APPROVAL FOR THE BTE FIREFLY, MODEL CI-5705.  THIS DEVICE PROVIDES SYSTEM VERIFICATION CAPABILITY TO CLINICIANS AND PARENTS INCLUDING BATTERY CHARGE STATUS, SYSTEM LOCK STATUS, AND PROGRAM SLOT INFORMATION.
P940022|S024|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|BTE FIREFLY (ADULT)|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2002|09/23/2002|||APPR|APPROVAL FOR THE BTE FIREFLY, MODEL CI-5705.  THIS DEVICE PROVIDES SYSTEM VERIFICATION CAPABILITY TO CLINICIANS AND PARENTS INCLUDING BATTERY CHARGE STATUS, SYSTEM LOCK STATUS, AND PROGRAM SLOT INFORMATION.
P940035|S003|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|NMP22 BLADDERCHEK TEST KIT|NAH|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/2002|04/25/2003|||APPR|APPROVAL FOR NEW TEST FORMAT TO BE MANUFACTURED AT MATRITECH, INC., NEWTON, MASSACHUSETTS AND AT A NEW FACILITY, UNOTECH DIAGNOSTICS, INC., SAN LEANDRO, CALIFORNIA.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NMP22 BLADDERCHEK KIT AND IS INDICATED FOR THE FOLLOWING:  THE MATRITECH NMP22 BLADDERCHEK TEST IS AN IN VITRO IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF NMP22 NUCLEAR MATRIX PROTEIN IN URINE OF PERSONS WITH RISK FACTORS OR SYMPTOMS OF BLADDER CANCER OR WITH A HISTORY OF BLADDER CANCER.  THIS TEST IS INDICATED FOR PROFESSIONAL USE AND PRESCRIPTION HOME USE AS AN AID IN DIAGNOSING AND MONITORING BLADDER CANCER PATIENTS, IN CONJUNCTION WITH STANDARD DIAGNOSTIC PROCEDURES.
P860004|S054|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC INTRATHECAL CATHETER MODEL 8731, MEDTRONIC INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2002|10/11/2002|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO INTRATHECAL CATHETER MODEL 8731:  1) PRE-ATTACHED TWO-PIECE CONNECTOR/ANCHOR  2) CATHETER TUBING MATERIAL WITH IMPROVED PHYSICAL PROPERTIES,  3) CATHETER TIP WITH IMPROVED RADIOPACITY,  4) LONGER INTRODUCER NEEDLE WITH DEPTH MARKINGS,  5) REVISION KITS (MODELS 8596 AND 8598), AND  6) CATHETER PASSER KITS (MODEL 8583 & 8686).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 8731 CLOSED-TIP INTRATHECAL CATHETER AND IS INDICATED FOR USE WITH THE MEDTRONIC SYNCHROMED OR ISOMED IMPLANTABLE INFUSION PUMP SYSTEMS TO ADMINISTER PARENTERAL DRUGS.
P990015|S002|LIFECORE BIOMEDICAL, INC.|3515 LYMAN BLVD.||CHASKA|MN|55318||BARRIER, ABSORABLE, ADHESION|GYNECARE INTERGEL ADHESION PREVENTION SOLUTION|MCN|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/2002|03/18/2003|||APPR|APPROVAL FOR CHANGES TO THE LABELING IN RESPONSE TO ADVERSE EVENT REPORTS OF ADDITIONAL SURGERY, INCLUDING HYSTERECTOMY, THAT OCCURRED FOLLOWING POST-OPERATIVE PAIN, ASCITES, NON-INFECTIOUS PERITONITIS, AND/OR POSSIBLE DELAYED CLEARANCE OF GYNECARE INTERGEL.
P940022|S025|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/2002|09/23/2002|||APPR|APPROVAL FOR CHANGING THE PRODUCT NAME OF THE HIRES SOFTWARE, MODEL NUMBER CI-6055.  THE SOFTWARE WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE, MODEL NUMBER CI-6055, AND IS INDICATED FOR USE IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12 MONTHS TO 17 YEARS, 11-MONTHS OF AGE).
P960058|S025|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/2002|09/23/2002|||APPR|APPROVAL FOR CHANGING THE PRODUCT NAME OF THE HIRES SOFTWARE, MODEL NUMBER CI-6055.  THE SOFTWARE WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE, MODEL NUMBER CI-6055, AND IS INDICATED FOR USE IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12 MONTHS TO 17 YEARS, 11-MONTHS OF AGE).
P010003|S002|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2002|10/08/2002|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CRYOLIFE, INC., KENNESAW, GEORGIA.
P860019|S187|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2002|10/23/2002|||OK30|CHANGE INVOLVING THE REDUCTION OF BIOSLIDE CURING TIME BY INCREASING THE ALLOWED PERCENT OXYGEN AND LEVEL OF UV EXPOSURE.
P980001|S041|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760||STENT, CORONARY|PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2002|10/23/2002|||OK30|CHANGE INVOLVING THE REDUCTION OF BIOSLIDE CURING TIME BY INCREASING THE ALLOWED PERCENT OXYGEN AND LEVEL OF UV EXPOSURE.
P020009|S001|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2002|10/23/2002|||OK30|CHANGE INVOLVING THE REDUCTION OF BIOSLIDE CURING TIME BY INCREASING THE ALLOWED PERCENT OXYGEN AND LEVEL OF UV EXPOSURE.
P990020|S011|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Express GMP Supplement|N|09/24/2002|10/24/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT MEDTRONIC AVE, INC., SANTA ROSA, CALIFORNIA.
P950034|S022|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/2002|10/25/2002|||APPR|APPROVAL FOR REVISED LABELING FOR SEPRAFILM ADHESION BARRIER TO REFLECT THE INTERIM FINDINGS OF THE STUDY APPROVED UNDER G980066, "A PROSPECTIVE, RANDOMIZED, MULTICENTER, CONTROLLED EVALUATION OF THE EFFICACY AND SAFETY OF SEPRAFILM BIORESORBABLE MEMBRANE IN THE REDUCTION OF THE INCIDENCE OF BOWEL OBSTRUCTION OF GENERAL SURGERY."  THE DEVICE, WITH THE MODIFIED LABELING, WILL BE MARKETED UNDER THE TRADE NAME SEPRAFILM ADHESION BARRIER, AND IS INDICATED FOR USE IN PATIENTS UNDERGOING ABDOMINAL OR PELVIC LAPAROTOMY AS AN ADJUNCT INTENDED TO REDUCE THE INCIDENCE, EXTENT, AND SEVERITY OF POSTOPERATIVE ADHESIONS BETWEEN THE ABDOMINAL WALL AND THE UNDERLYING VISCERA SUCH AS OMENTUM, SMALL BOWEL, BLADDER AND STOMACH, AND BETWEEN THE UTERUS AND SURROUNDING STRUCTURES SUCH AS TUBES AND OVARIES, LARGE BOWEL, AND BLADDER.
P000049|S005|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2002|10/23/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE DEVICE WHICH INVOLVES THE REMOVAL OF THE REQUIREMENT FOR ROUTINE TESTING OF ANAEROBIC BACTERIA FROM NMT PRODUCT BIOBURDEN PROCEDURE.
P000009|S005|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/25/2002|12/20/2002|||APPR|APPROVAL FOR  1) NEW ADDITIONAL PULSE GENERATORS TO THE BELOS FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND  2) MODIFICATIONS TO THE LEGALLY MARKETED BELOS VR/VR-T ICD SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BELOS DR, DR-T, VR, VR-T ICD SYSTEMS AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYMIAS.
P810046|S213|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||CATHETER, FLOW DIRECTED|ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS|DYG|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2002|10/23/2002|||OK30|CHANGE TO A REVISED SAMPLING GROUP AND A PYROGEN SAMPLING PLAN FOR CORONARY DILATATION CATHETERS.
P870072|S022|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2002|10/29/2002|||APPR|APPROVAL FOR THE ADDITION OF INSPECTIONS, TEST METHODS, AND SPECIFICATIONS FOR THE CONTROLLER BOARDS FOR THE TLC-II PORTABLE VAD DRIVER.
P000052|S011|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2002|02/10/2003|||APPR|APPROVAL FOR CERAMIC GLASS FIBER AS AN ALTERNATE SOURCE WIRE FIBER MATERIAL IN THE GDT-P32-1 SOURCE WIRE, A COMPONENT OF THE GALILEO III INTRAVASCULAR THERAPY SYSTEM.
P990019|S002|DUSA PHARMACEUTICALS, INC.|25 UPTON DR.||WILMINGTON|MA|01887||SYSTEM, LASER, PHOTODYNAMIC THERAPY|BLU-U|MVF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2002|01/09/2003|||APPR|APPROVAL FOR EXTENSION OF THE CALIBRATION INTERVAL FROM THE CURRENTLY APPROVED 500 CYCLES (WITH A 50 CYCLE BUFFER) TO 1600 CYCLES (WITH A 50 CYCLE BUFFER).
P990071|S003|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|STOCKERT 70 RF GENERATOR WITH SOFTWARE VERSION 1.033|DRF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/2002|10/21/2002|||APPR|APPROVAL TO MODIFY THE STOCKERT 70 GENERATOR SO AS TO DELIVER UP TO 70 WATTS OF POWER WHEN USED WITH THE NAVISTAR DS AND CELSIUS DS CATHETERS.  THE STOCKERT 70 RF GENERATOR IS INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CATHETER ABLATION PROCEDURES.
P930016|S016|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Panel Track|Change Design/Components/Specifications/Material|N|10/01/2002|05/23/2003|03M-0333|07/30/2003|APPR|APPROVAL FOR THE VIXX STAR S4 ACTIVETRAK  EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM.  THE DEVICE USES A 6.00 MM OPTICAL ZONE, AN 8.00 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR:  1) THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D;  2) PATIENTS 21 YEARS OF AGE OR OLDER; AND  3) PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.50 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.
P990066|S015|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/2002|11/21/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE APPROVED SYSTEM TO PERMIT USE OF AN OPTIONAL CONTRAST ENHANCEMENT ALGORITHM (DYNAMIC RANGE MANAGEMENT) INTRODUCTION OF NEW DISPLAY PROTOCOLS AND MINOR CHANGES IN THE DISPLAY SCENARIOS, AND ADDITION OF KEYBOARD SHORTCUTS FOR WINDOW WIDTH/WINDOW LEVEL SETTINGS.  THE SUPPLEMENT ALSO INCLUDES CHANGES IN THE LABELING TO REFLECT THE MODIFICATIONS LISTED ABOVE.
P850048|S018|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM|LTJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|10/04/2002|01/09/2003|||APPR|APPROVAL TO ADD THE ACCESS HYBRITECH PSA ASSAY TO THE SYNCHRON LXI 725 SYSTEM.
P010031|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC MODEL 7272 INSYNC ICD|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/02/2002|10/23/2002|||APPR|APPROVAL FOR A CHANGE TO THE CONNECTOR ASSEMBLY OF THE MEDTRONIC MODEL 7272 INSYNC ICD.
P790019|S016|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|HAVAB-M EIA|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2002|11/06/2002|||OK30|CHANGES TO  1) REPLACE LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM LITTON BIONETICS WITH NON-LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM JACKSON IMMUNO RESEARCH.  2) REPLACE RHEOPHORESIS TESTING FOR GOAT ANTI-HUMAN IGM (ANTIBODY) IDENTITY/SPECIFICITY WITH IMMUNOELECTRO-PHORESIS (IEP) TESTING.  3) REPLACE HAVAB-M RIA (RADIOIMMUNOASSAY) ANTIBODY BEAD COAT EFFICACY TESTING WITH SMALL-SCALE ANTIBODY DILUTION FACTOR DETERMINATION AND CONFIRMATION TESTING USING HAVAB-M EIA (ENZYME IMMUNOASSAY) TO ESTABLISH THE OPTIMAL DILUTION FACTOR OF THE GOAT ANTI-HUMAN IGM ANTIBODY TO BE USED FOR FULL-SCALE PRODUCTION BEAD COATING.
P020009|S002|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2002|11/05/2002|||OK30|CHANGING THE QUALITY CONTROL ACCEPTANCE CRITERIA FOR THE STAINLESS STEEL TUBING (RAW MATERIAL) USED TO MANUFACTURE THE STENT COMPONENT FOR THE DEVICES.
P970038|S006|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 SYSTEM|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|10/07/2002|01/09/2003|||APPR|APPROVAL TO ADD THE ACCESS HYBRITECH FREE PSA ASSAY TO THE SYNCHRON LXI 725 SYSTEM.
P860019|S188|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK OTW/RANGER PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2002|10/24/2002|||APPR|APPROVAL FOR AN ALTERNATE PACKAGING AND STERILIZATION FACILITY LOCATED AT COSMED GROUP, INC., COVENTRY, RHODE ISLAND.
P010033|S001|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2002|10/24/2002|||OK30|CHANGE IN THE MANUFACTURING OF MICROTITER PLATES FROM A SEMI-MANUAL TO AN AUTOMATED PROCESS.
P960043|S042|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE A-T 6 FR. SUTURE MEDICATED CLOSURE (SMC) SYSTEM|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/08/2002|11/12/2002|||APPR|APPROVAL FOR EXPANDING THE INDICATIONS FOR USE OF THE CLOSER A-T 6 FR. SMC SYSTEM TO INCLUDE 7 AND 8 FR. SHEATH SIZES AND TO CHANGE THE LABELING TO INCLUDE <0.038" GUIDEWIRES.
P970061|S017|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|RADIUS CORONARY STENT AND DELIVERY CATHETER|MAF|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2002|10/29/2002|||APPR|APPROVAL FOR AN ALTERNATE PACKAGING CONFIGURATION.
P860019|S189|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NC MONORAIL/NC BIG RANGER/NC RANGER PTCA CATHETHERS|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/2002|11/06/2002|||APPR|APPROVAL FOR AN ADDITIONAL INSTRUCTION IN THE DIRECTIONS FOR USE MANUAL IN ORDER TO ENHANCE SAFE DEVICE USE.
P000049|S006|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QUICK LOAD|MLV|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2002|02/21/2003|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY LOCATED AT PROFESSIONAL CONTRACT STERILIZATION, INC, TAUNTON, MASSACHUSETTS.
P000027|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/2002|02/24/2003|||APPR|APPROVAL FOR DESIGN CHANGES TO MODIFY THE COMPOSITION AND VOLUMES OF THE REAGENTS, AND LABELING CHANGES TO ADD CLAIMS FOR THE USE OF LITHIUM AND NH4-HEPARIN PLASMA SAMPLES, TO ELIMINATE THE RECOMMENDATION FOR NA CITRATE PLASMA, AND TO OMIT THE SAMPLE DILUTION CLAIM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS FREE PSA IMMUNOASSAY AND IS INDICATED FOR THE IN VITRO QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN IN HUMAN SERUM AND PLASMA.  THE ELECSYS FREE PSA IMMUNOASSAY IS INDICATED FOR MEASUREMENT OF FPSA IN CONJUNCTION WITH THE ELECSYS TOTAL PSA ASSAY TO DEVELOP A RATIO (%FPSA) OF FPSA TO TPSA.  THIS RATIO IS USEFUL WHEN USED IN CONJUNCTION WITH THE ELECSYS TOTAL PSA TEST AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIONS IN MEN AGE 50 YEARS OR OLDER WHO HAVE A DIGITAL RECTAL EXAMINATION (DRE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND AN ELECSYS TOTAL PSA VALUE IN THE RANGE 4 NG/ML TO 10 NG/ML.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THE ELECTROCHEMILUMI-NISCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE DIAGNOSTICS ELECSYS 1010 AND 2010, AND THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS.
P000011|S007|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|BIODIVYSIO OC/SV OTW STENT DELIVERY SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2002|11/14/2002|||OK30|CHANGE IN VENDOR FOR THE BALLOON MATERIAL.
P000046|S006|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2002|03/18/2003|||APPR|APPROVAL FOR AN ADDITIONAL METHOD FOR ENDOTOXIN TESTING.
P000025|S005|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/15/2002|10/29/2002|||APPR|APPROVAL FOR THE MED-EL SURGICAL CLAW, WORKING ANGLE -45 DEGREES, AS A MODIFICATION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL SURGICAL CLAW, WORKING ANGLE -45 DEGREES, AND IS INDICATED FOR USE WHERE THERE IS PLANNED ACCESS TO THE INNER EAR DURING SURGERY.
P000018|S025|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|Normal 180 Day Track||N|10/15/2002|01/06/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATION AND MANUFACTURING PROCESS FOR THE BETA-RAIL 3.5F DELIVERY CATHETER (WITH 30 AND 40 MM INDICATOR SOURCE TRAIN).
P990017|S036|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE SYSTEM|MIH|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2002|11/08/2002|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO.
P000006|S003|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|MENTOR TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/2002|07/14/2003|||APPR|APPROVAL FOR MARKETING CLAIMS REGARDING WATER ABSORPTION BY THE TITAN INFLATABLE PENILE PROSTHESIS.
P890019|S007|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|DIASORIN ETI-AB-HAVK PLUS|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2002|11/08/2002|||OK30|CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
P890014|S004|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|ETI-HA-IGMK PLUS KIT|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2002|11/08/2002|||OK30|CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
P990038|S003|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-MAK-2 PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2002|11/08/2002|||OK30|CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
P990041|S002|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2002|11/08/2002|||OK30|CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
P990043|S003|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2002|11/08/2002|||OK30|CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
P990044|S002|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-CORE-IGMK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2002|11/08/2002|||OK30|CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
P990045|S003|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2002|11/08/2002|||OK30|CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
P990028|S005|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Mesh, surgical, polymeric|FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT|FTL|AN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/2002|11/25/2002|||APPR|APPROVAL FOR THE ADDITION OF A BOX AROUND THE CONTRAINDICATIONS SECTION OF THE INSTRUCTIONS FOR USE FOR FOCALSEAL-L SEALANT.
P970035|S043|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MEDTRONIC AVE S7 ZIPPER MX CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/18/2002|10/28/2002|||APPR|APPROVAL FOR THE ADDITION OF TWO NEW INDICATIONS FOR THE MEDTRONIC AVE S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM, SPECIFICALLY FOR DIRECT STENTING AND FOR THE TREATMENT OF SAPHENOUS VEIN GRAFTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC AVE S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <=30 MM) IN NATIVE CORONARY ARTERIES AND SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM USING DIRECT STENTING OR PRE-DILATATION.  LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P000018|S026|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH 3.5F SYSTEM|MOU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/18/2002|11/13/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE USER'S MANUAL, USER'S GUIDE AND CUSTOMER TRAINING TO INCLUDE ADDITIONAL INFORMATION ON SCENARIOS WHERE THE BETA-RAIL 3.5F DELIVERY CATHETER TIP MAY BE SUBJECTED TO EXCESSIVE FORCE AND THE TECHNIQUES FOR AVOIDING AND/OR RESOLVING THESE SCENARIOS.
P900043|S042|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS) - SAPHENOUS VEIN GRAFN|MAF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/2002|03/04/2004|||APPR|APPROVAL FOR A NEW SAPHENOUS VEIN GRAFT (SVG) INDICATION FOR THE BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE (OTW) OR RAPTORRAIL (RX) STENT DELIVERY SYSTEMS (SDS).  THE DEVICE IS INDICATED FOR THE TREATMENT OF: PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<= 30 MM IN LENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM;ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM; AND,PATIENTS WITH DE NOVO OR RESTENOTIC SAPHENOUS VEIN GRAFT LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM
P010018|S001|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CK SYSTEM (KERATOPLAST TIP COMPONENT)|MWD|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2002|10/28/2002|||OK30|ALTERNATIVE/ EQUIVALENT UV CURABLE ADHESIVE TO BE USED IN THE BONDING PROCESS DURING MANUFACTURE OF THE KERATOPLAST TIP.
P000052|S012|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|10/21/2002|11/18/2002|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P000018|S027|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2002|10/23/2003|||APPR|APPROVAL TO CHANGE AN ELECTRONIC DATA MANAGEMENT SYSTEM, REFERRED TO AS THE BETACAL SYSTEM.
P990018|S003|MENICON CO. LTD.|269 A BALLARDVALE STREET||WILMINGTON|MA|01887||Lens,contact(rigid gas permeable)-extended wear|MENICON Z|MWL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2002|11/06/2002|||APPR|APPROVAL FOR ALCON UNIQUE-PH MULTI-PURPOSE SOLUTION AS AN ALTERNATE WET SHIPPING SOLUTION FOR THE MENICON Z RIGID GAS PERMEABLE CONTACT LENS.
P990053|S010|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/2002|11/15/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING.
P970058|S015|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER|MYN|RA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2002|03/04/2003|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT R2 TECHNOLOGIES, INC. SUNNYVALE, CALIFORNIA.
P970061|S018|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|RADIUS CORONARY STENT W/DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2002|11/25/2002|||APPR|APPROVAL FOR AN ALTERNATE STERILILZATION FACILITY LOCATED AT COSMED GROUP, INC.COVENTRY, RHODE ISLAND.
P010032|S005|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2002|12/23/2002|||APPR|APPROVAL FOR THE QUICK LINK CONTROLLER MODEL 3860 FOR USE WITH THE GENESIS MODEL 3608, 3609, 3644 AND 3604 IMPLANTED PULSE GENERATORS WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P860019|S190|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|BOSTON SCIENTIFIC ACE/TRAPPER/SURPASS/REMEDY PTCA CATHETERS|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2002|11/25/2002|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED GROUP, INC., COVENTRY, RHODE ISLAND.
P860026|S008|AVERY BIOMEDICAL DEVICES, INC.|61 MALL DR.||COMMACK|NY|11725|5703|implanted diaphragmatic/phrenic nerve Stimulator|DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR|GZE|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/2002|03/03/2003|||APPR|APPROVAL FOR SELECTING A FINAL VALUE OF C22 AND C50 CAPACITORS DURING PRODUCTION TESTING BASED ON PARAMETERS MEASURED WITH CALIBRATED TEST EQUIPMENT TO RESULT IN PEAK OPERATING PERFORMANCE OF THE TRANSMITTER.
P970003|S045|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/2002|02/28/2003|||APPR|APPROVAL FOR THE FOLLOWING LABELING CHANGE TO THE INDIVIDUALIZATION OF TREATMENT SECTION OF THE MODEL 100/101 AND 102 PHYSICIAN'S MANUALS  "PRECLINICAL STUDY, TERATOGENIC EFFECTS; THERE ARE NO ADEQUATE AND WELL-CONTROLLED STUDIES OF VNS IN PREGNANT WOMEN.  REPRODUCTION STUDIES HAVE BEEN PERFORMED USING FEMALE RABBITS STIMULATED WITH THE COMMERCIALLY AVAILABLE VNS THERAPY SYSTEM AT STIMULATION DOSE SETTINGS SIMILAR TO THOSE USED FOR HUMANS.  THESE ANIMAL STUDIES HAVE REVEALED NO EVIDENCE OF IMPAIRED FERTILITY OR HARM TO THE FETUS DUE TO VNS THERAPY.  BECAUSE ANIMAL REPRODUCTION STUDIES ARE NOT ALWAYS PREDICTIVE OF HUMAN RESPONSE AND ANIMAL STUDIES CANNOT ADDRESS DEVELOPMENTAL ABNORMALITIES, VNS SHOULD BE USED DURING PREGNANCY ONLY IF CLEARLY NEEDED.  ALTHOUGH THE OPERATING RANGES OF THE VNS THERAPY SYSTEM AND FETAL MONITORS ARE DISSIMILAR AND NO INTERACTION WOULD BE EXPECTED, TESTING HAS NOT BEEN PERFORMED.  THEREFORE, THE POTENTIAL MAY EXIST FOR INTERACTION BETWEEN THE VNS THERAPY SYSTEM AND FETAL MONITORING SYSTEMS."
P980046|S005|HOME ACCESS HEALTH CORP.|2401 W. HASSELL|SUITE 1510|HOFFMAN ESTATES|IL|60195|5200|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|HOME ACCESS HEPATITIS C TEST SERVICE|MZO|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/2002|12/06/2002|||APPR|APPROVAL FOR A REDUCTION OF A SUPPLEMENT TESTING RANGE (STR) FROM SPECIMENS WITH A SIGNAL-TO-CUTOFF VALUE FROM 5.0 TO 4.2.
P940022|S026|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CLARION CII BIONIC EAR SYSTEM (ADULT)|MCM|EN|Real-Time Process|Other Report|N|10/25/2002|11/01/2002|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE POSTMARKET STUDY PROTOCOL:  1) USE OF ONLY THE PB-K TEST TO DETERMINE CANDIDACY IN CHILDREN 4 YEARS THROUGH 17 YEARS OF AGE AT TIME OF IMPLANT.  2) SUBSTITUTION OF THE PB-K TEST FOR THE ESP TEST AS AN OUTCOME MEASURE.  3) DIVISION OF THE YOUNGEST AGE GROUP INTO TWO GROUPS.  4)  ADDITIONAL INCLUSION/EXCLUSION CRITERIA FOR ADULTS AND CHILDREN.
P960058|S026|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)|MCM|EN|Real-Time Process|Postapproval Study Protocol - ODE/OIR|N|10/25/2002|11/01/2002|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE POSTMARKET STUDY PROTOCOL:  1) USE OF ONLY THE PB-K TEST TO DETERMINE CANDIDACY IN CHILDREN 4 YEARS THROUGH 17 YEARS OF AGE AT TIME OF IMPLANT.  2) SUBSTITUTION OF THE PB-K TEST FOR THE ESP TEST AS AN OUTCOME MEASURE.  3) DIVISION OF THE YOUNGEST AGE GROUP INTO TWO GROUPS.  4)  ADDITIONAL INCLUSION/EXCLUSION CRITERIA FOR ADULTS AND CHILDREN.
P960058|S027|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2002|11/06/2002|||APPR|APPROVAL FOR A REVISION TO THE PACKAGE INSERT (DOCUMENT NUMBER 9196252-001) THAT MODIFIED THE PERCENTAGE OF PATIENTS WHO PREFERRED HIGH RESOLUTION SOUND PROCESSING TO CONVENTIONAL SOUND PROCESSING.  THIS MODIFICATION IS BASED ON UPDATED DATA RECEIVED FROM PATIENTS AT THE 12-MONTH FOLLOW-UP VISIT WHICH SHOWED THAT THREE OF THE FIVE PATIENTS WHO ORIGINALLY PREFERRED THEIR CONVENTIONAL STRATEGY AT THE THREE-MONTH EXPERIMENTAL STRATEGY VISIT SWITCHED THEIR PREFERENCE TO HIRES.  THUS, 48 OF 50 PATIENTS (96%) ULTIMATELY PREFERRED HIRES.
P940022|S027|ADVANCED BIONICS CORP.|12740 SAN FERNANDO RD.||SYLMAR|CA|91342||IMPLANT, COCHLEAR|CALRION CII BIONIC EAR SYSTEM (ADULT)|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2002|11/06/2002|||APPR|APPROVAL FOR A REVISION TO THE PACKAGE INSERT (DOCUMENT NUMBER 9196252-001) THAT MODIFIED THE PERCENTAGE OF PATIENTS WHO PREFERRED HIGH RESOLUTION SOUND PROCESSING TO CONVENTIONAL SOUND PROCESSING.  THIS MODIFICATION IS BASED ON UPDATED DATA RECEIVED FROM PATIENTS AT THE 12-MONTH FOLLOW-UP VISIT WHICH SHOWED THAT THREE OF THE FIVE PATIENTS WHO ORIGINALLY PREFERRED THEIR CONVENTIONAL STRATEGY AT THE THREE-MONTH EXPERIMENTAL STRATEGY VISIT SWITCHED THEIR PREFERENCE TO HIRES.  THUS, 48 OF 50 PATIENTS (96%) ULTIMATELY PREFERRED HIRES.
P830037|S047|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/25/2002|11/26/2002|||APPR|APPROVAL FOR AN ADDITIONAL COLORANT TO BE USED IN THE COLORANT PROCESS AND A REVISION TO THE LABELING TO MOVE THE STATEMENT "THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE" FROM THE ACTIONS SECTION OF THE PACKAGE INSERT TO THE INDICATIONS SECTION.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FRESHOOK TRADE NAME WITH THE FOLLOWING INDICATIONS:  VISION CORRECTION SPHERICAL: FRESHLOOK SPHERICAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 2.0 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE.  TORIC FRESHLOOK TORIC (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 6.0 DIOPTERS.  THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE.  THE LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR IN NOT-APHAKIC PERSONS FROM 1 TO 7 DAYS BETWEEN REMOVAL FOR CLEANING AN DISINFECTION OR DISPOSAL, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL OR FOR DAILY WEAR IN APHAKIC PERSONS.  THE EYE CARE PROFESSIONAL MAY PRESCRIBE THE LENS IN EITHER THE SINGLE-USE DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WITH CLEANING, DISINFECTION AND SCHEDULED REPLACEMENT.  WHEN PRESCRIBED FOR FREQUENT REPLACEMENT, THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM.  FRESHLOOK SOFT CONTACT LENSES WITH UV-ABSORBING MONOMER HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
P010038|S001|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|ICAD|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/2002|02/24/2003|||APPR|APPROVAL FOR USE OF THE 3.9.3.7 VERSION OF THE SOFTWARE.  THE NEW SOFTWARE IS INTENDED TO IMPROVE THE OVERALL SENSITIVITY, IMPROVE THE BREAST SEGMENTATION PROCESS, REDUCE THE FALSE MARKER RATE AND IMPROVE THE OVERALL CONSISTENCY OF THE ALGORITHM.  THE CLINICAL PERFORMANCE CLAIMS ARE NOT CHANGED.
P000058|S002|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/2002|07/29/2004|||APPR|APPROVAL FOR 1) THE EXTENSION OF THE LEVELS OF USE OF THE DEVICE FROM L4-S1 TO L2-S1 2) MODIFICATION OF THE INDICATION TO ALLOW FOR THE DEVICE TO BE USED IN SUBJECTS WHO MAY HAVE RETROLISTHESIS IN CONJUNCTION WITH DEGENERATIVE DISC DISEASE 3) CHANGE IN STORAGE TEMPERATURE LIMIT AND 4) REVISIONS TO INSTRUCTION FOR USE.
P010038|S002|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|ICAD|MYN|RA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/28/2002|11/20/2002|||APPR|APPROVAL FOR A DEVICE NAME CHANGE FROM "MAMMOREADER" TO "ICAD."
P990038|S004|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN HBSAG CONFIRMATORY TEST|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/29/2002|03/14/2003|||APPR|APPROVAL FOR USE OF A DIASORIN HBSAG CONFIRMATORY REAGENT TO CONFIRM ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES, AND USE OF A DIASORIN CONFIRMATORY REAGENT SPECIFICALLY IN PRENATAL SCREENING TO CONFIRM ALL ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES IN THE ABSENCE OF OTHER HBV MARKER TESTING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIASORIN HBSAG CONFIRMATORY TEST AND IS INDICATED FOR AN IN VITRO NEUTRALIZATION ASSAY FOR QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA SAMPLES (EDTA, HEPARIN, AND CITRATE) FOUND TO BE REPEATEDLY REACTIVE FOR HBSAG BY ETI-MAK-2 PLUS.  THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.
P990042|S005|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2002|11/26/2002|||OK30|CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
P900052|S012|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM|LNY|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2002|12/17/2002|||APPR|APPROVAL FOR:  1) THE ADDITION OF PROCEDURAL ACCESSORIES TO THE PORT-A-CATH EPIDURAL SYSTEM KIT, 2) AN  ALTERNATE PACKAGING CONFIGURATION AND  3) CHANGE IN ETHYLENE OXIDE RESIDUAL LIMITS.  THESE ADDED ACCESSORIES ARE EXACTLY THE SAME AS THOSE DESCRIBED IN P900052/S005 FOR PORT-A-CATH II EPIDURAL LOW-PROFILE SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH EPIDURAL SYSTEM KITS.
P970015|S021|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE|MAX|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2002|06/24/2003|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY TO PERFORM PACKAGING FOR TERMINAL STERILIZATION.  THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK, WARSAW, INDIANA.  ALSO, APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA STERIGENICS, WESTERVILLE, OHIO AND AN ADDITIONAL TESTING FACILITY LOCATED AT NAMSA, NORTHWOOD, OHIO.
P970015|S022|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/30/2002|09/10/2003|||APPR|APPROVAL FOR THE LT-CAGE PEEK LUMBER TAPERED FUSION DEVICE, WHICH IS MANUFACTURED FROM POLYETHERETHERKE-TONE, WITH THE TRADE NAME OF PEEK-OPTIMA LT1.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGERNERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL.  LT-CAGE PEEK IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH.  PATIENTS RECEIVING THE LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE SHOULD HAVE AT LEAST SIX MONTHS OF NON-OPERATIVE TREATMENT PRIOR TREATMENT WITH THE LT-CAGE PEEK DEVICE.
P840024|S084|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2002|12/09/2002|||APPR|APPROVAL FOR EXPANSION OF THE MANUFACTURING FACILITY LOCATED AT COCHLEAR LIMITED, LANE COVE, AUSTRALIA.
P890027|S053|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT FOR CHILDREN|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2002|12/09/2002|||APPR|APPROVAL FOR EXPANSION OF THE MANUFACTURING FACILITY LOCATED AT COCHLEAR LIMITED, LANE COVE, AUSTRALIA.
P980008|S012|LASERSIGHT TECHNOLOGIES, INC.|6903 UNIVERSITY BLVD.,||WINTER PARK|FL|32792||Excimer laser system|LSX EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2002|12/16/2002|||APPR|APPROVAL FOR AN INCREASE OF THE PULSE REPETITION FREQUENCY FROM THE PRESENT VALUE (200 HZ.) TO 300 HZ.
P970051|S023|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2002|12/09/2002|||APPR|APPROVAL FOR EXPANSION OF THE MANUFACTURING FACILITY LOCATED AT COCHLEAR LIMITED, LANE COVE, AUSTRALIA.
P000015|S003|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2002|12/09/2002|||APPR|APPROVAL FOR EXPANSION OF THE MANUFACTURING FACILITY LOCATED AT COCHLEAR LIMITED, LANE COVE, AUSTRALIA.
P010012|S005|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FINISHING WIRE UNIVERSAL|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2002|12/30/2002|||APPR|APPROVAL FOR A MODIFICATION TO THE EASYTRAK FINISHING WIRE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FINISHING WIRE UNIVERSAL, MODELS 6001 - 6007 AND IS INDICATED FOR USE WITH GUIDANT CORONARY VENOUS LEADS.
P960058|S028|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2002|11/25/2002|||APPR|APPROVAL FOR MINOR CHANGES TO THE HIFOCUS ELECTRODE TO BETTER FACILITATE THE PACKING OF THE COCHLEOSTOMY AND ELECTRODE INSERTION.  SPECIFICALLY, THE CHANGES ARE TO MOVE THE OFFSET REGION APPROXIMATELY 3 MM FURTHER AWAY FROM THE CURRENT LOCATION.
P990035|S006|BEAM-MED LTD|8 HALAPID STR.||PETACH TIKVA||49170||Bone sonometer|SUNLIGHT OMNISENSE BONE SONOMETER|MUA|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2002|04/24/2003|||APPR|APPROVAL FOR SOFTWARE MANAGEMENT MODULE "SUNLIGHT DESKTOP" (SLD).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNLIGHT DESKTOP, SLD AND IS AN ADD-ON TO THE OMNISENSE SOFTWARE THAT WILL FUNCTION AS AN INDEPENDENT APPLICATION.  THE SUNLIGHT DESKTOP SOFTWARE ENABLES THE USER TO SHUT DOWN THE OMNISENSE SOFTWARE LEAVING THE PC SYSTEM OPERATING, SO THAT THE USER CAN THEN INITIATE ANY OTHER INSTALLED SOFTWARE (PER THE SOFTWARE MANUFACTURER REQUIREMENTS, WHICH WILL OPERATE INDEPENDENT OF THE OMNISENSE SOFTWARE.  THIS WILL ALLOW THE USE OF SEVERAL DEVICES WITH THE CONTROL OF ONE PC.
P950020|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON ULTRA|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2002|04/30/2003|||APPR|APPROVAL FOR DESIGN CHANGES IN THE CUTTING BALLOON, BOTH THE OVER-THE-WIRE (OTW) AND MONORAIL (MR) CONFIGURATIONS, AND FOR MANUFACTURING CHANGES FOR THE MR CONFIGURATION.  ADDITIONALLY, APPROVAL TO ADD THE TRADE NAME CUTTING BALLOON ULTRA2 FOR BOTH CONFIGURATIONS AND TO ADD WARNINGS TO THE INSTRUCTIONS FOR USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON ULTRA2 AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.  IN ADDITION, THE TARGET LESION SHOULD POSSES THE FOLLOWING CHARACTERISTICS: DISCRETE (<= 15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH); WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.0 MM TO 4.0 MM; READILY ACCESSIBLE TO THE DEVICE; LIGHT TO MODERATE TORTUOSITY OF PROXIMAL VESSEL SEGMENT, NON-ANGULATED LESION SEGMENT (<45 DEGREES), SMOOTH ANGIOGRAPHIC CONTOUR; AND ABSENCE OF ANGIOGRAPHICALLY-VISIBLE THROMBUS AND/OR CALCIFICATION.
P000025|S006|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2002|03/18/2003|||APPR|APPROVAL FOR BROADENING THE INDICATION OF THE C40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE CHILDREN AGED TWELVE MONTHS OR OLDER.
P970037|S001|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA HAFP TEST KIT|LOK|IM|Special (Immediate Track)||N|10/18/2002|11/27/2002|||APPR|APPROVAL FOR LABELING CHANGES TO THE PATIENT AND PHYSICIAN BROCHURES AND 3 VERSIONS OF THE PACKAGE INSERT FOR THE LABORATORY.
P010032|S006|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS G4 NEUROSTIMULATION(IPG)SYSTEM(MODEL 3604)|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2002|12/23/2002|||APPR|APPROVAL FOR THE GENESIS G4 NEUROSTIMULATION (IPG) SYSTEM (MODEL 3604) WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P930029|S018|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2002|12/17/2002|||APPR|APPROVAL FOR A CABLE THAT WILL ALLOW A MEDTRONIC RADIO-FREQUENCY ABLATION CATHETER TO FUNCTION AS A DIAGNOSTIC CATHETER BY PROVIDING CONNECTIVITY TO AN EP RECORDING SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE AND IS INDICATED FOR USE DURING DIAGNOSTIC ELECTROPHYSIOLOGIC STUDIES IN CONJUNCTION WITH MEDTRONIC ELECTRODE CATHETERS.  THE CABLE IS USED DURING ELECTROPHYSIOLOGY STUDIES TO CONNECT THE ELECTRODE CATHETER TO THE ECG RECORDING/ STIMULATION EQUIPMENT.
P930038|S034|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/2002|12/20/2002|||APPR|APPROVAL FOR THE ADDITION OF CLINICAL DATA RELATED TO USE OF THE ANGIO-SEAL STS 6FR DEVICE IN DIAGNOSTIC PATIENTS.
P830055|S083|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/05/2002|12/17/2002|||APPR|APPROVAL FOR THE ADDITION OF THICKER POLYETHYLENE TIBIAL BEARING COMPONENTS FOR THE SIGMA RP STABILIZED POLYETHYLENE BEARING COMPONENTS OF THE LCS TOTAL KNEE SYSTEM.
P000052|S013|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2002|01/21/2003|||APPR|APPROVAL FOR AN AUTOMATED PROCESS FOR THE TIP FORMING OPERATION OF THE GALILEO III CENTERING CATHETER.
P000028|S003|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|AFFINITY ANTERIOR CERVICAL CAGE SYSTEM|MAX|OR|Normal 180 Day Track|Express GMP Supplement|N|11/08/2002|07/02/2003|||APPR|APPROVAL FOR ADDITIONAL MANUFACTURING FACILITY TO PERFORM PACKAGING FOR TERMINAL STERILIZATION.  THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK, WARSAW, INDIANA.  ALSO, APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA STERIGENICS, WESTERVILLE, OHIO AND AN ADDITIONAL TESTING FACILITY LOCATED AD NAMSA, NORTHWOOD, OHIO.
P970021|S006|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|CATHETER, BALLOON, TRANSCERVICAL|THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MKN|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/2002|05/07/2003|||APPR|APPROVAL FOR A MATERIAL CHANGE TO THE SILIXONE BALLOON.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM.
P960053|S003|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, finger, constrained, metal/polymer|BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS|KWG|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2002|12/31/2002|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT RMS CO., MINNEAPOLIS, MINNESOTA AND A NEW STERILIZATION FACILITY LOCATED AT MICRONET MEDICAL, INC., ST. PAUL, MINNESOTA.
P020003|S001|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Prosthesis, testicular|MENTOR SALINE-FILLED TESTICULAR PROSTHESIS|FAF|GU|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|11/07/2002|02/05/2003|||APPR|APPROVAL FOR REVISION OF THE POSTAPPROVAL STUDY PROTOCOL TO DISCONTINUE THE REQUIREMENT FOR BLOOD COLLECTION AT THE 5-YEAR EXAM.
P920014|S017|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORETEC HEARTMATE XVE LVAS|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/12/2002|04/04/2003|||APPR|APPROVAL FOR AN EXPANDED INDICATION FOR USE FOR THE THORATEC HEARTMATE XVE LVAS.  THIS DEVICE SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE.  IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV END STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 60 OF THE LAST 90 DAYS, AND WHO HAVE A LIFE EXPECTANCY OF LESS THAN TWO YEARS, AND WHO ARE NOT ELIGIBLE FOR CARDIAC TRANSPLANTATION.  THE DEVICE SYSTEM IS APPROVED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.
P920014|S018|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE LVAS|DSQ|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2002|04/01/2003|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT THORATEC CORPORATION, PLEASANTON, CALIFORNIA.
P860057|S019|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2002|05/09/2003|||APPR|APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).
P010041|S002|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. PORCINE BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2002|05/09/2003|||APPR|APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).
P000007|S003|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2002|05/09/2003|||APPR|APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).
P870077|S013|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2002|05/09/2003|||APPR|APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).
P870056|S015|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND|DYE|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2002|08/22/2003|||APPR|APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERTNIC TEMPERATURE INDICATOR (HIGH AND LOW).
P010012|S006|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD/EASYTRAK LEADS & ACCESSORIES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P950001|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE LEADS AND ACCESSORIES|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P830060|S051|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK LEADS AND ACCESSORIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P910073|S040|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK/ENDURANCE/RELIANCE LEADS AND ACCESSORIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P910077|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX LEADS AND ACCESSORIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P960004|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE/FINELINE LEADS AND ACCESSORIES|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P960006|S007|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEETIP RX/SWEET PICOTIP RX/FLEXTEND|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P940008|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q ACCESSORIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P930035|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 LEADS AND ACCESSORIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2002|12/13/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
P860019|S191|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER|LOX|CV|Normal 180 Day Track|Express GMP Supplement|N|11/14/2002|01/27/2003|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED GROUP, INC., COVENTRY, RHODE ISLAND.
P980018|S001|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|DAKO HERCEPTEST|MVC|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/15/2002|12/12/2002|||APPR|APPROVAL FOR MINOR LABELING CHANGES.
P010049|S003|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM|MGB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2002|11/27/2002|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY TO PERFORM DEVICE ASSEMBLY AND PACKAGING, LOCATED AT SUB-Q, INC., SAN CLEMENTE, CALIFORNIA.
P950037|S028|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/15/2002|12/06/2002|||APPR|APPROVAL FOR  1) THE COMBINATION OF ALL THE FEATURES OF THE PHILOS FAMILY WITH THE CLOSED LOOP STIMULATION (CLS METHOD OF RATE ADAPTIVE PACING; AND  2) THE ADDITION OF THE PROTOS APPLICATION TO THE SWM AND ATA PROGRAMMER SOFTWARE CARTRIDGES,   THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROTOS VR AND PROTOS DR; AND SOFTWARE CARTRIDGES              B-K00.P.U AND     A-K00.0.U, AND IS INDICATED FOR:  A) RATE ADAPTIVE PACING WITH THE PROTOS PACING SYSTEM IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.  B)  GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD-DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME.  C) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
P960043|S043|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|SUTURE TRIMMER FOR THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/18/2002|12/20/2002|||APPR|APPROVAL FOR DESIGN CHANGES TO THE SUTURE TRIMMER (ST).  SPECIFICALLY THE ST WAS MODIFIED TO OPERATE BY SLIDING RATHER THAN BY CLEAVING THE SUTURE BY CUTTING SURFACE ROTATION.
P010031|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION 3|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/2002|03/27/2003|||APPR|APPROVAL FOR THE MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY AND INSYNC MARQUIS APPLICATION SOFTWARE MODEL 9983 AND FOR THE SYSTEM TO BE MANUFACTURED AT MED REL, HUMACACO, PUERTO, RICO, MEDTRONIC, EUROPE S.A, TOLOCHENAZ, SWITZERLAND AND MEDTRONIC BV, KERKRADE, THE NETHERLANDS.
P990009|S013|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/2002|03/10/2005|||APPR|APPROVAL FOR AN ALTERNATE KIT CONFIGURATION THAT CONTAINS A HUMAN THROMBIN COMPONENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL HEMOSTATIC MATRIX AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P010039|S002|SIEMENS MEDICAL SOLUTIONS USA, INC.|51 VALLEY STREAM PKWY.||MALVERN|PA|19355|1406|Generator, shock-wave, for pain relief|SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM|NBN|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|11/13/2002|04/03/2003|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.  THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE JULY, 19, 2002 APPROVAL ORDER FOR P010039.
P880098|S012|MENICON CO. LTD.|269A BALLARDVALE ST.||WILMINGTON|MA|01887||Lens, contact (other material) - daily|MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS|HQD|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/19/2002|12/10/2002|||APPR|APPROVAL FOR ALCON UNIQUE-PH MULTI-PURPOSE SOLUTION AS AN ALTERNATE WET SHIPPING SOLUTION FOR THE MENICON SF-P RIGID GAS PERMEABLE CONTACT LENS, LABELING CHANGES TO REFLECT THE USE OF ALCON UNIQUE-PH AS A PACKAGING SOLUTION AND TO UPDATE THE LABELING IN ACCORDANCE WITH RECENTLY APPROVED MENICON RIGID GAS PERMEABLE CONTACT LENS LABELING.
P930038|S035|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2002|12/20/2002|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSERTION SHEATH (ADDITION OF PUNCTURE HOLES), GUIDEWIRE (INCREASE GUIDEWIRE SIZE FOR THE 6FR. DEVICE), PUNCTURE LOCATOR (MOVE LOCATOR HOLES, LABEL LOCATION (MOVE TO OUTSIDE OF PACKAGE) AND THE INSTRUCTIONS FOR USE (REVISE LABELING TO INCLUDE NEW INSTRUCTIONS RELATED TO THESE DESIGN CHANGES).
P010050|S001|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE,IMMULITE 1000 HBSAG,CONFIRMATORY AND IMMULITE 2000 HBSAG,CONFIRMATORY KIT|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2002|03/13/2003|||APPR|APPROVAL FOR USE OF THE IMMULITE/IMMULITE 1000 HBSAG/CONFIRMATORY AND IMMULITE 2000 HBSAG/CONFIRMATORY KIT ON THE IMMULITE 1000 AUTOMATED ANALYZER.
P010051|S001|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2002|03/13/2003|||APPR|APPROVAL FOR USE OF THE IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBC IGM ON THE IMMULITE 1000 AUTOMATED ANALYZER.
P010052|S001|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2002|03/13/2003|||APPR|APPROVAL FOR USE OF THE IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS ON THE IMMULITE 1000 AUTOMATED ANALYZER.
P010053|S001|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2002|03/13/2003|||APPR|APPROVAL FOR USE OF THE IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC ON THE IMMULITE 1000 AUTOMATED ANALYZER.
P820076|S023|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|PERMANENT PACEMAKER ELECTRODE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2002|12/20/2002|||OK30|REDUCTION IN THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS UTILIZED DURING THE STANDARD STERILIZATION PROCESS, FROM 7 DAYS TO 3 DAYS.
P950037|S029|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|PROTOS FAMILY OF PULSE GENERATORS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2002|12/20/2002|||OK30|REDUCTION IN THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS UTILIZED DURING THE STANDARD STERILIZATION PROCESS, FROM 7 DAYS TO 3 DAYS.
P000009|S006|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2002|12/20/2002|||OK30|REDUCTION IN THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS UTILIZED DURING THE STANDARD STERILIZATION PROCESS, FROM 7 DAYS TO 3 DAYS.
P980023|S011|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S)|DTA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2002|12/20/2002|||OK30|REDUCTION IN THE INCUBATION TIME OF THE BIOLOGICAL INDICATORS UTILIZED DURING THE STANDARD STERILIZATION PROCESS, FROM 7 DAYS TO 3 DAYS.
P000052|S014|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/2002|12/17/2002|||APPR|APPROVAL TO INCLUDE A WARNING STATEMENT IN THE INSTRUCTIONS FOR USE FOR THE GALILEO III CENTERING CATHETER ADVISING THE USER NOT TO EXCEED A PRESSURE OF 4 ATM, AS POSSIBLE OVEREXPANSION OF THE INFLATION LUMEN COULD RESULT.
P000008|S005|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2002|01/08/2003|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT INAMED CORPORATION, SANTA BARBARA, CALIFORNIA.
P970055|S001|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|BIOTRON PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|MYM|MI|Special (Immediate Track)||N|11/15/2002|01/09/2003|||APPR|APPROVAL FOR ADDING A QUALITY ASSURANCE INSPECTION STEP.
P970054|S001|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY|MYL|MI|Special (Immediate Track)||N|11/15/2002|01/09/2003|||APPR|APPROVAL FOR ADDING A QUALITY ASSURANCE INSPECTION STEP.
P000029|S002|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2002|12/18/2002|||OK30|CHANGE IN SITE FOR BACTERIAL ENDOTOXIN TESTING FOR THE DEFLUX NEEDLE, A COMPONENT OF THE DEFLUX DEVICE.  THE TESTING IS CURRENTLY CONDUCTED AT A CONTRACT FACILITY, NAMSA, AND WILL BE MOVED TO Q-MED'S MICROBIOLOGY QC LABORATORY IN UPPSALA, SWEDEN.  THERE WILL ALSO BE A CHANGE OF TEST METHOD FROM KINETIC-CHROMOGENIC LAL PROCEDURE TO THE GEL CLOT LAL TEST.
P960013|S011|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL SDX MODEL 1488T/TC/K|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/22/2002|02/25/2003|||APPR|APPROVAL FOR TENDRIL LEAD LENGTH CHANGE.
P990001|S012|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/2002|05/20/2003|||APPR|APPROVAL FOR THE MODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS INCLUDING THE UPGRADE OF THE SELECTION AFM MODEL 902 TO INCLUDE VENTRICULAR RATE STABILIZATION.
P860019|S192|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NC BIG RANGER PTCA CATHETER|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/2002|12/17/2002|||APPR|APPROVAL TO MODIFY THE LABELING TO EXTEND THE BALLOON COMPLIANCE CHART DIAMETERS TO HUNDREDTHS AND TO ADD A NOTE TO THE DIRECTIONS FOR USE STATING THE RECOMMENDED MINIMUM GUIDE CATHETER LUMEN INNER DIAMETER.
P000049|S007|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIK LOAD|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2002|12/23/2002|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO ADD AN ALTERNATE VENDOR FOR THE DELIVERY SYSTEM Y-BODY ASSEMBLY.
P820060|S016|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER|LOJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/26/2002|02/02/2004|||APPR|APPROVAL FOR THE USE OF THE ABBOTT ARCHITECT AFP ASSAY ON THE ARCHITECT I2000SR ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT ARCHITECT AFP ASSAY FOR THE ARCHITECT I2000 ANALYZER AND IS INDICATED FOR THE FOLLOWING: 1) HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOSUS TESTICULAR CANCER.  2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF OPEN NEURAL TUBE DEFECTS (NTD).  TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD.
P860003|S042|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2002|12/20/2002|||OK30|CHANGE IN THE STERILIZATION PROCESS FOR THE UVAR XTS PHOTOPHERESIS SYSTEM.
P990017|S037|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE ENDOGRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Express GMP Supplement|N|11/27/2002|01/02/2003|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE FOLDED BALLOON SUBASSEMBLY LOCATED AT GUIDANT CORPORATION, TEMECULA, CALIFORNIA.
P000046|S007|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2002|03/12/2003|||APPR|APPROVAL FOR USE OF AN ALTERNATE RAW MATERIAL SOURCE.
P980052|S002|TMJ CONCEPTS|2233 KNOLL DRIVE||VENTURA|CA|93003||Joint, temporomandibular, implant|TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM|LZD|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/27/2002|01/14/2003|||APPR|APPROVAL FOR THE ADDITION OF THE STERILE PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TO BE STERILIZED AT TMJ CONCEPTS, VENTURA, CALIFORNIA.
P860004|S055|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED APPLICATION SOFTWARE FOR MODEL 8870, MEDTRONIC INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2002|12/17/2002|||APPR|APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE 8870 SYNCHROMED APPLICATION SOFTWARE, APPROVED AS P860004/S052, FOR USE WITH THE N'VISION PROGRAMMING SYSTEM CONTAINED ON MODEL 8870 APPLICATION CARD.  THE SPECIFIC CHANGES ARE:  1) A CHANGE TO THE 8870 SYNCHROMED APPLICATION PROTOCOL DRIVER TO ENSURE SYNCHRONIZATION AND  2) A MICROPROCESSOR-RESET FEATURE TO THE THERAPY STOP FUNCTION TO RESET THE STACK POINTER.
P980053|S005|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2002|05/28/2003|||APPR|APPROVAL FOR MARKETING DURASPHERE PACKAGED IN 3 ML SYRINGES.
P010049|S004|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL II ARTERIAL CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2002|02/10/2003|||APPR|APPROVAL TO MODIFY THE DESIGN OF THE DEPTH MARKET COMPONENT AND ELONGATE THE EXISTING CAVITY IN THE TRAY TO ACCOMMODATE THE DEPTH MARKET MODIFICATION.
P970003|S046|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2002|09/30/2003|||APPR|APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS (HYDROGEN PEROXIDE GAS PLASMA USING  THE STERRAD 200 GMP STERILIZER) FOR THE MODEL 401 TUNNELER AND APPROVAL OF A PROTOCOL FOR B1 INCUBATION REDUCTION AND SHELF LIFE STUDY, AS WELL AS A NEW STERILIZATION FACILITY (CYBERONICS, INC., HOUSTON, TEXAS).
P980022|S010|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)|MDS|CH|Panel Track|Change Design/Components/Specifications/Material|N|11/29/2002|01/07/2004|12M-0965|09/12/2012|APPR|APPROVAL FOR THE GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS).  THE DEVICE IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF INTERSTITIAL GLUCOSE VALUES IN PERSONS WITH DIABETES MELLITUS.  GLUCOSE VALUES CALCULATED BY THE DEVICE WILL BE USED TO TRIGGER HYPO- AND HYPERGLYCEMIA ALERTS BUT GLUCOSE VALUES WILL NOT BE DISPLAYED.  UP TO 21 DAYS OF STORED DATA CAN BE DOWNLOADED TO A PERSONAL COMPUTER TO IDENTIFY PATTERNS AND OPTIMIZE DIABETES MANAGEMENT.
P980035|S025|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|KAPPA 700/600, 900/800, SIGMA/MEDTRONIC 350|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2002|02/21/2003|||APPR|APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
P870072|S023|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/03/2002|11/20/2003|||APPR|APPROVAL FOR THE USE OF THE VAD SYSTEM IN THE HOME ENVIRONMENT AND FOR THE ADDITION OF TWO ACCESSORIES FOR THE THORATEC VAD SYSTEM: THE MOBILE COMPUTER AND THE CAR POWER ADAPTER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM AND TLC-II PORTABLE VAD DRIVER.  THE PVAD IS INDICATED FOR USE IN BRIDGE TO TRANSPLANT PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA: CANDIDATE FOR CARDIAC TRANSPLANTATION, IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, DEPENDENCE ON, OR INCOMPLETE RESPONSE TO, CONTINUED VASOPRESSOR SUPPORT.  IT IS ALSO INDICATED FOR POST CARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS.  THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL OR FOR TRANSPORTATION OF VAD PATIENTS VIA GROUND AMBULANCE.
P970012|S014|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|KAPPA 400|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2002|02/21/2003|||APPR|APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
P900061|S053|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM MODEL 7227 CX/B/D/E|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2002|02/21/2003|||APPR|APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
P980016|S030|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III DR 7275, GEM III VR 7231, GEM DR 7271|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2002|02/21/2003|||APPR|APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
P980050|S013|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT 7276|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2002|02/21/2003|||APPR|APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
P010015|S008|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC IPG 8040|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2002|02/21/2003|||APPR|APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
P010031|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC ICD 7272|NIK|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2002|02/21/2003|||APPR|APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
P990001|S013|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|DIVA PLATFORM,DERMA PLATFORM|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2002|02/21/2003|||APPR|APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
P000029|S003|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/03/2002|12/13/2002|||APPR|APPROVAL FOR AN INCREASE IN THE LABELED STORAGE TEMPERATURE TO 25 DEGREES C AND AN EXPIRATION DATE OF 18 MONTHS AFTER MANUFACTURE.
P980041|S003|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM|LOK|IM|Real-Time Process|Other Report|N|12/04/2002|01/29/2003|||APPR|APPROVAL FOR EXPANDING THE USE OF ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCESS AFP IMMUNOASSAY SYSTEM AND IS INDICATED FOR THE QUANTITATIVE DETERMINATIONS OF ALPHA-FETOPROTEIN (AFP) IN:  1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER.  2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO 20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD).  TEST RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD.  THE ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMIOGRAPHY.
P950022|S015|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA SERIES DEFIBRILLATION LEAD SYSTEM|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/04/2002|01/22/2003|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING AND TACHYCARDIA LEADS.
P960030|S009|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T|DTB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/04/2002|01/22/2003|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.
P880086|S090|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|AV PLUS DX, MODEL 1368|KRG|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/04/2002|01/22/2003|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.
P960013|S012|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K|DTB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/04/2002|01/22/2003|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.
P860057|S020|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2002|12/31/2002|||OK30|CHANGE IN THE METHOD TO REDUCE BIOBURDEN.
P870056|S016|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2002|12/31/2002|||OK30|CHANGE IN THE METHOD TO REDUCE BIOBURDEN.
P870077|S014|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2002|12/31/2002|||OK30|CHANGE IN THE METHOD TO REDUCE BIOBURDEN.
P010041|S003|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2002|12/31/2002|||OK30|CHANGE IN THE METHOD TO REDUCE BIOBURDEN.
P840024|S085|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/2002|04/02/2003|||APPR|APPROVAL FOR THE NEW R126 VERSION 2 SOFTWARE AND IF6 CARD.
P890027|S054|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/2002|04/02/2003|||APPR|APPROVAL FOR THE NEW R126 VERSION 2 SOFTWARE AND IF6 CARD.
P970051|S024|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/2002|04/02/2003|||APPR|APPROVAL FOR THE NEW R126 VERSION 2 SOFTWARE AND IF6 CARD.
P000015|S004|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/06/2002|04/02/2003|||APPR|APPROVAL FOR THE NEW R126 VERSION 2 SOFTWARE AND IF6 CARD.
P000025|S007|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/2002|06/05/2003|||APPR|APPROVAL OF AN INDICATION FOR USE ALLOWING THE USE OF MAGNETIC RESONANCE IMAGING (MRI) AT 0.2 TESLA FOR PATIENTS IMPLANTED WITH COMBI 40+ COCHLEAR IMPLANTS (C40+, C40+S AND C40+GB ELECTRODE ARRAYS).
P870072|S024|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/11/2002|12/31/2002|||APPR|APPROVAL FOR THE ADDITION OF A WARNING STATEMENT TO THE PACKAGE LABELS AND TO THE INSTRUCTIONS FOR USE FOR THE BEVELED-TIP ATRIAL CANNULA, AS USED WITH THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM.
P010033|S002|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2002|12/17/2002|||OK30|CHANGE IN THE SUBSTRATE REAGENT USED IN THE KIT FROM A TWO-SOLUTION SUBSTRATE SYSTEM TO A ONE-SOLUTION SUBSTRATE SYSTEM.
P910077|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND MINI ICDS|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/2002|03/21/2003|||APPR|APPROVAL FOR CHANGES TO THE PATIENT HANDBOOKS.
P940031|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR AND DISCOVERY MERIDIAN AR|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/2002|03/21/2003|||APPR|APPROVAL FOR CHANGES TO THE PATIENT HANDBOOKS.
P960040|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV AND VENTAK PRIZM DR/VR AICDS|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/2002|03/21/2003|||APPR|APPROVAL FOR CHANGES TO THE PATIENT HANDBOOKS.
P010012|S007|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD|NIK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/2002|03/21/2003|||APPR|APPROVAL FOR CHANGES TO THE PATIENT HANDBOOKS.
P930031|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2002|01/10/2003|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATIC CLEANING AND PASSIVATION PROCESS.
P940019|S013|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2002|01/10/2003|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATIC CLEANING AND PASSIVATION PROCESS.
P980033|S004|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2002|01/10/2003|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATIC CLEANING AND PASSIVATION PROCESS.
P010002|S003|COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES|150 GLOVER AVE.||NORWALK|CT|06856||Tissue adhesive for the topical approximation of skin|INDERMIL TISSUE ADHESIVE|MPN|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/13/2002|01/31/2003|||APPR|APPROVAL FOR THE ADDITION OF A PATIENT INSTRUCTION SHEET TO THE APPROVED LABELING.
P990026|S016|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH G2 BIOGRAPHER|CGA|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2002|12/31/2002|||OK30|CHANGE IN THE PCBA WASH PROCESS IN THE PCBA ASSEMBLY SEQUENCE TO INCREASE THE EFFICIENCY OF THE PROCESS AND TO REDUCE COST.
P930029|S019|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|MEDTRONIC ENHANCER ABLATION CATHETERS|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2002|01/08/2003|||APPR|APPROVAL FOR A MANUFACTURING PROCESS CHANGE TO ADD AN ADDITIONAL QUALITY CONTROL INSPECTION.
P000039|S003|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2002|01/15/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO OBTAIN AN ALTERNATE SUPPLIER FOR COMPONENTS USED WITH THE AMPLATZER SEPTAL OCCLUDER AND DELIVERY EXCHANGE SYSTEMS.
P840024|S086|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS)|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2002|12/27/2002|||APPR|APPROVAL FOR MODIFICATION OF THE COIL/CABLE OF THE ESPRIT 3G SPEECH PROCESSOR TO ENABLE NUCLEUS 22 USERS TO ACCESS THE TECHNOLOGICAL BENEFITS OF THE ESPRIT 3G.
P890027|S055|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT FOR CHILDREN|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2002|12/27/2002|||APPR|APPROVAL FOR MODIFICATION OF THE COIL/CABLE OF THE ESPRIT 3G SPEECH PROCESSOR TO ENABLE NUCLEUS 22 USERS TO ACCESS THE TECHNOLOGICAL BENEFITS OF THE ESPRIT 3G.
P000058|S003|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2002|06/24/2003|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR ASSEMBLING AND PACKAGING THE PARTS OF THE INFUSE BONE GRAFT COMPONENT OF THE DEVICE.  THE FACILITY IS LOCATED AT MEDTRONIC SOFAMOR DANEK USA, INC., MEMPHIS, TENNESEE.
N18033|S038|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2002|01/08/2003|||APPR|APPROVAL FOR AN ALTERNATIVE BINDING POLYMER TO THE ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER.
P930031|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2002|01/17/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE WALLSTENT DELIVERY SYSTEM WHICH INVOLVES THE REPLACEMENT OF THE CATHETER HUB BOND TO STAINLESS STEEL TUBE BOND CURE TIME WITH A REDUCED SET TIME.
P790017|S078|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2002|02/04/2003|||APPR|APPROVAL FOR MANUFACTURING CHANGES TO THE STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY.
P980033|S005|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2002|01/17/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE WALLSTENT DELIVERY SYSTEM WHICH INVOLVES THE REPLACEMENT OF THE CATHETER HUB BOND TO STAINLESS STEEL TUBE BOND CURE TIME WITH A REDUCED SET TIME.
P940019|S014|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2002|01/17/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE WALLSTENT DELIVERY SYSTEM WHICH INVOLVES THE REPLACEMENT OF THE CATHETER HUB BOND TO STAINLESS STEEL TUBE BOND CURE TIME WITH A REDUCED SET TIME.
P900061|S054|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2002|01/06/2003|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING AND PACKAGING FACILITY LOCATED AT MEDTRONIC ARIZONA DEVICE MANUFACTURING, TEMPE, ARIZONA.
P000052|S015|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2002|01/17/2003|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR MOUNTING THE FPGA CHIP OF THE GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM.
P790025|S008|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT: 09VA BLDG: AP6C-2|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT HBE (RDNA) EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2002|01/17/2003|||OK30|CHANGES TO MANUFACTURING PROCESS, TEST METHOD ADDITIONS, AND SPECIFICATION CHANGES.
P980037|S006|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2002|01/14/2003|||APPR|APPROVAL FOR MODIFICATION TO THE MANUFACTURING PROCEDURES FOR MOUNTING OF THE HARDWARE TO THE DRIVE UNIT CONTROL BOARD (I.E., IMPLEMENTATION OF A MINIMUM TORQUE REQUIREMENT).
P000009|S007|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TACHOS ATX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND PROGRAMMER SOFTWARE|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2002|05/29/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, TACHOS ATX AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING ARRHYTHMIAS.  THE DEVICE IS INDICATED FOR USE IN ICD PATIENTS EITHER WITH ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.
P910016|S013|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|LCS UNICOMPARTMENTAL KNEE SYSTEM|MBD|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2002|12/17/2003|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT DEPUY IRELAND, LTD., CORK, IRELAND.
P850048|S019|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS|LTJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2002|03/03/2003|||APPR|APPROVAL TO ADD THE ACCESS HYBRITECH PSA ASSAY TO THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM.
P970038|S007|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2002|02/28/2003|||APPR|APPROVAL TO ADD THE ACCESS HYBRITECH FREE PSA ASSAY TO THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM.
P980016|S031|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 7230 MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2002|03/06/2003|||APPR|APPROVAL FOR A MOVE OF THE EUROPEAN OPERATIONS CENTER FROM KERKRADE, THE NETHERLANDS TO MEDTRONIC B.V., HEERLEEN, THE NETHERLANDS.
P910066|S017|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS|LOF|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/2002|08/01/2003|||APPR|APPROVAL FOR VARIOUS LABELING, SOFTWARE AND HARDWARE CHANGES.
P900009|S016|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM|LPQ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/2002|02/21/2003|||APPR|APPROVAL FOR CHANGES TO THE EXOGEN 3000* LABELING IN ORDER THAT IT MORE CLOSELY RESEMBLE THE APPROVED LABELING FOR THE EXOGEN 2000+*.
P020014|S001|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2002|03/06/2003|||APPR|APPROVAL FOR A MODIFIED DELIVERY CATHETER CALLED THE COIL CATHETER AND A MODIFIED SPLIT INTRODUCER.
P950029|S017|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2002|10/24/2003|||APPR|APPROVAL FOR NEW PACEMAKER MODELS, SYMPHONY MODELS 2550, AND 2250 AND ELA RHAPSODY MODELS 2530, 2510 AND 2210.  THE SYMPHONY AND ELA RHAPSODY PACEMAKER SYSTEMS ARE INDICATED FOR:  1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY.  2) THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE, BUT ARE NOT RESTRICTED TO: A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND- OR THIRD-DEGREE AV BLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS: D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES.  IN ADDITION, THE DUAL-CHAMBER AND ATRIAL TRACKING MODES (SYMPOHONY DR MODEL 2550 AND ELA RHAPSODY DR MODELS 2530 AND 2510) ARE INDICATED FOR PATITNES WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.  DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE:  1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND 2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.
P020009|S004|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS AND EXPRESS2 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2002|01/22/2003|||OK30|ALTERNATE LASER CUTTING SPEED TO MANUFACTURE THE STENT COMPONENT FOR THE EXPRESS AND EXPRESS2 CORONARY STENT SYSTEMS.
P990080|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SILICONE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2002|02/04/2003|||APPR|APPROVAL FOR TESTING ETHYLENE OXIDE RESIDUALS ON A QUARTERLY BASIS.
P010012|S008|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK RENEWAL 3 CRT-D MODELS H170/H175, CONTAK RENEWAL 3 HE CRT-D MODELS H177/H179, AND MODEL 2845 VERSION 2.2 SOFTWARE|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/2002|06/13/2003|||APPR|APPROVAL FOR THE CONTAK RENEWAL 3 CRT-D MODELS H170/H175, CONTAK RENEWAL 3 HE CRT-D MODELS H177/H179, AND MODEL 2845 VERSION 2.2 SOFTWARE.  THE CONTAK RENEWAL 3 SYSTEM IS INDICATED FOR PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY. PATIENT POPULATIONS AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS INCLUDE, BUT ARE NOT LIMITED TO, THOSE WITH:1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA.  2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).  NOTE: THE CLINICAL OUTCOME OF HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS IS NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.  3) PRIOR MYOCARDIAL INFARCTION, LEFT VENTRICULAR EJECTION FRACTION OF <=35%, AND A DOCUMENTED EPISODE OF NONSUSTAINED VT, WITH AN INDUCIBLE VENTRICULAR TACHY-ARRHYTHMIA. PATIENTS SUPPRESSIBLE WITH IV PROCAINAMIDE OR AN EQUIVALENT ANTIARRHYTHMIC (DRUG) HAVE NOT BEEN STUDIED.
P880086|S091|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2002|01/22/2003|||APPR|APPROVAL FOR MODEL 3307 (VERSION 4.1A) PROGRAMMER SOFTWARE FOR SJM MODELS 3500/3510 PROGRAMMER.
P830045|S083|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2002|01/22/2003|||APPR|APPROVAL FOR MODEL 3307 (VERSION 4.1A) PROGRAMMER SOFTWARE FOR SJM MODELS 3500/3510 PROGRAMMER.
P910023|S063|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2002|01/22/2003|||APPR|APPROVAL FOR MODEL 3307 (VERSION 4.1A) PROGRAMMER SOFTWARE FOR SJM MODELS 3500/3510 PROGRAMMER.
P900070|S028|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||Programmer, pacemaker|APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2002|01/22/2003|||APPR|APPROVAL FOR MODEL 3307 (VERSION 4.1A) PROGRAMMER SOFTWARE FOR SJM MODELS 3500/3510 PROGRAMMER.
P010013|S004|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2002|01/16/2003|||APPR|APPROVAL FOR A MANUFACTURING AND MATERIAL CHANGE TO THE CERVICAL COLLAR COMPONENT OF THE DISPOSABLE DEVICE.
P860019|S194|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER|LOX|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2002|04/01/2003|||APPR|APPROVAL TO MANUFACTURE THE REMEDY CATHETER BALLOON COMPONENT AT BOSTON SCIENTIFIC IRELAND LIMITED, GALWAY, IRELAND.
P020009|S005|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/24/2002|01/24/2003|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) TO MORE CLEARLY INSTRUCT THE USER REGARDING THE METHODS FOR REMOVAL OF AN UNEXPANDED STENT.
P830061|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC MODELS CAPSURE SP 4092, CAPSURE SP 4592, CAPSURE SP 4023, CAPSURE SP 4523 AND CAPSURE SENSE 4073; VITATRON...|DTB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2002|05/09/2003|||APPR|APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.
P930039|S014|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MDX SILICONE TUBING|DTB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2002|05/09/2003|||APPR|APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.
P980016|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL CAPSUREFIX 6940|LWS|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2002|05/09/2003|||APPR|APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.
P850089|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC MODELS CAPSURE SP 5023M, CAPSURE SP 5524M AND CAPSURE Z 5033|DTB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2002|05/09/2003|||APPR|APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.
P950024|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC MODEL CAPSUREEPI 4695 AND CAPSUREEPI 4968|DTB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2002|05/09/2003|||APPR|APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.
P000023|S004|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS|LZD|DE|Normal 180 Day Track|Other Report|N|12/26/2002|10/14/2003|||APPR|APPROVAL FOR THE PACKAGING/SHELF LIFE TESTING PROTOCOL TO EXTEND THE SHELF LIFE BEYOND 6 MONTHS.
P000035|S004|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS|MPI|DE|Normal 180 Day Track|Other Report|N|12/26/2002|10/14/2003|||APPR|APPROVAL FOR THE PACKAGING/SHELF LIFE TESTING PROTOCOL TO EXTEND THE SHELF LIFE BEYOND 6 MONTHS.
P950022|S016|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA DEFIBRILLATION LEAD SYSTEM MODEL 1572 AND 1582|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/31/2002|03/25/2003|||APPR|APPROVAL FOR SINGLE DEFIBRILLATION COIL LEAD MODELS 1572 AND 1582.
P020004|S001|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER TM BIFURCATED ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2002|01/30/2003|||OK30|ALTERNATE VENDOR FOR THE LEG HOLD RING USED IN THE MANUFACTURE OF THE GORE EXCLUDER BIFURCATED ENDOPROSTHESIS.
P950005|S017|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS AND CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/02/2003|02/04/2003|||APPR|APPROVAL FOR ESTABLISHING AND EXTENDING PACKAGE AND PRODUCT SHELF LIVES.
P010068|S001|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS|OAD|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/02/2003|02/04/2003|||APPR|APPROVAL FOR ESTABLISHING AND EXTENDING PACKAGE AND PRODUCT SHELF LIVES.
P990025|S008|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|DRF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/02/2003|02/04/2003|||APPR|APPROVAL FOR ESTABLISHING AND EXTENDING PACKAGE AND PRODUCT SHELF LIVES.
P020004|S002|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROSTHEIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/2003|05/05/2003|||APPR|APPROVAL FOR A MODIFICATION MADE TO THE MATERIAL OF THE DEPLOYMENT LINE OF THE DELIVERY SYSTEM FOR THE EXCLUDER BIFURCATED ENDOPROSTHESIS.
P000018|S028|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH 3.5F SYSTEM - 60 MM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/06/2003|06/25/2003|||APPR|APPROVAL FOR THE 60 MM BETA-CATH 3.5F SYSTEM.  THE DEVICE, AS MODIFIED, IS INDICATED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS (TREATABLE WITH A 20 MM BALLOON FOR THE 30 MM AND 40 MM SYSTEMS AND INJURY AREAS UP TO 40 MM FOR THE 60 MM SYSTEM) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.
P970008|S023|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2003|07/07/2003|||APPR|APPROVAL FOR 1) THE RTU PLUS, A MODIFIED VERSION OF THE RECTAL THERMOSENSING UNIT (RTU), AND  2) LABELING CHANGES.  THE RTU PLUS INCLUDES A DISPOSABLE BALLOON AND REUSABLE HANDLE, AND WILL BE AVAILABLE AS AN ALTERNATIVE TO THE EXISTING SINGLE USE RTU.
P950037|S030|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/09/2003|08/04/2003|||APPR|APPROVAL FOR A MODIFIED PHILOS DR PACING SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1 AND IS INDICATED FOR USE IN PATIENTS WITH STANDARD BRADYCARDIA PACING INDICATIONS.  RATE-ADAPTIVE PACING WITH THE PHILOS DR ACC PULSE GENERATOR IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.  GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME.  PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.
P780007|S043|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|BIOMEDICS 38 (POLYMACON) UV BLOCKING CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Express GMP Supplement|N|01/10/2003|09/12/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT OCULAR SCIENCES, ALBUQUERQUE, NEW MEXICO.
P960058|S029|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CLARION CII BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/2003|02/04/2003|||APPR|APPROVAL FOR AN OPTIONAL, ADJUNCT SOFTWARE [NEURAL RESPONSE IMAGING (NRI)] TO IMPLEMENT A CAPABILITY TO MEASURE AND RECORD A NEURAL RESPONSE USING THE SIGNAL GENERATED AND DETECTED BY THE IMPLANT ELECTRONICS.
P970021|S007|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|CATHETER, BALLOON, TRANSCERVICAL|GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MKN|OB|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2003|03/27/2003|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, INC., BOULDER, COLORADO. THE GYNECARE THERMACHOICE CONTROLLER WILL BE MANUFACTURED AT THIS FACILITY.
P990028|S006|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Mesh, surgical, polymeric|FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT|FTL|AN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/15/2003|02/04/2003|||APPR|APPROVAL FOR REVISION OF STORAGE INSTRUCTIONS IN THE PRODUCT LABEL.
P940015|S008|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC|MOZ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/15/2003|07/09/2003|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF SYNVISC TO 36 MONTHS AT 30 DEGREES C.
P970021|S008|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|CATHETER, BALLOON, TRANSCERVICAL|GYNECARE THERMACHOICE II UTERINE BALLOON THERAPY SYSTEM|MKN|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/15/2003|07/14/2003|||APPR|APPROVAL FOR MODIFIED LABELING FOR THE THERMACHOICE II.
P910018|S009|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2003|02/14/2003|||OK30|CHANGE IN PACKAGING FOR THE LIPOSORBER LA-15 SYSTEM.
P790017|S079|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2003|03/04/2003|||APPR|APPROVAL TO MAKE MODIFICATIONS TO THE STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER AND ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE NC STORMER BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM - 4.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.  NOTE:  BENCH TESTING WAS CONDUCTED WITH THE NC STORMER BALLOON DILATATION CATHETER AND MARKETED BALLOON EXPANDABLE STENTS.  CONSIDERATION WOULD BE TAKEN WHEN THE DEVICE IS USED WITH DIFFERENT MANUFACTURERS' STENTS DUE TO DIFFERENCES IN STENT DESIGN.
P910023|S064|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ST.JUDE MEDICAL EPIC/ATLAS DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2003|02/12/2003|||OK30|CHANGE IN THE SUPPLIER FOR THE HIGH VOLTAGE CAPACITOR CATHODE MATERIAL USED FOR THE ST. JUDE MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P000052|S016|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Normal 180 Day Track|Express GMP Supplement|N|01/17/2003|06/27/2003|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SOURCE BLANK SUBASSEMBLY.  THE FACILITY IS LOCATED AT GUIDANT CORPORATION, HOUSTON, TEXAS.
P990037|S012|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/17/2003|01/30/2003|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE.  SPECIFICALLY,  1) REMOVAL OF THE SILICONE GASKET FROM THE PRESSURE RELIEF VALVE DESIGN;  2) REMOVAL OF A LUER LOCK THREAD/ATTACHMENT WHICH WAS USED TO CONNECT THE CATHETER TO THE PRESSURE RELIEF VALVE AND REPLACE WITH AN ADHESIVE BOND;  3) REMOVAL OF THE CAP COVER AND THREADS FROM THE RELIEF VALVE, AND  4) SHORTENING OF THE LENGTH AND HEIGHT OF THE RELIEF VALVE.
P000018|S029|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH 3.5F SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/2003|07/18/2003|||APPR|APPROVAL FOR THE BETA-RAIL 3.5F XL DELIVERY CATHETER AND ENHANCED BETA-RAIL 3.5F DELIVERY CATHETER.
P000040|S003|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO-THERMABLATOR(HTA) ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2003|02/20/2003|||APPR|APPROVAL FOR A REVISED HTA SYSTEM INSTALLATION AND OPERATOR'S MANUAL.
P950039|S009|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2003|02/05/2003|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT:  1) THE ADDITION OF A CONTRAINDICATION FOR THOSE SAMPLES PROCESSED USING THE THINPREP 3000 PROCESSING SYSTEM.  2) THE ADDITION OF A PRECAUTION TO ADDRESS THE ALTERNATIVE SPECIMEN PROCESSING METHODS USING THE THINPREP 2000 PROCESSING SYSTEM FOR THOSE SAMPLES THAT WILL BE TESTED FOR CHLAMYDIA TRACHOMATIS  AND NEISSERIA GONORRHOEAE USING THE ROCHE DIAGNOSTICS COBAS AMPLICOR CT/NG TEST.  3) THE ADDITION OF THE ALTERNATIVE SPECIMEN HANDLING METHOD TO TABLE 1 OF THE PACKAGE INSERT.
P010007|S001|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|IMMULITE AFP AND IMMULITE 2000 AFP|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|01/21/2003|02/24/2003|||APPR|APPROVAL FOR USE OF THE IMMULITE AFP ON THE IMMULITE 1000 AUTOMATED ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE/IMMULITE 1000 AFP AND IS INDICATED:  FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE AND IMMULTE 1000 ANALYZERS - FOR THE QUANTITATIVE MEASUREMENT OF ALPHA-FETOPROTEIN (AFP) IN EITHER OF TWO CONTEXTS: (A) SERIAL MEASUREMENTS IN HUMAN SERUM TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER; OR (B) MEASUREMENTS IN MATERNAL SERUM AND AMNIOTIC FLUID DURING GESTATIONAL WEEKS 15 THROUGH 20 - USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY - TO AID IN DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS.
P930027|S005|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA|LTJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|01/21/2003|02/28/2003|||APPR|APPROVAL FOR THE ADDITION OF THE IMMULITE 1000 ANALYZER TO THE ANALYZERS USED FOR THE IMMULITE PSA AND IMMULITE THIRD GENERATION PSA ASSAYS.
P990037|S013|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT SEALING DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2003|02/21/2003|||OK30|CHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING ACHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING AND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.ND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.
P010032|S007|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/23/2003|03/05/2003|||APPR|APPROVAL FOR THE RAPID PROGRAMMER WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P000039|S004|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2003|02/21/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE SUPPLIER FOR THE END SCREW ATTACHMENT AND DELIVERY CABLE DISTAL END SCREW OF THE AMPLATZER SEPTAL OCCLUDER AND AMPLATZER   45 DEGREE DELIVERY AND EXCHANGE SYSTEMS.
P900023|S038|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2003|09/24/2003|||APPR|APPROVAL FOR THE AB5000 BLOOD PUMP, USED ONLY WITH THE AB5000 CONSOLE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM AND IS INDICATED FOR USE IN PATIENTS SUFFERING FROM REVERSIBLE VENTRICULAR DYSFUNCTION.  THESE ARE PATIENTS WHO HAVE UNDERGONE SUCCESSFUL CARDIAC SURGERY AND SUBSEQUENTLY DEVELOP LOW CARDIAC OUTPUT, OR PATIENTS WHO SUFFER FROM ACUTE CARDIAC DISORDERS LEADING TO HEMODYNAMIC INSTABILITY.  THE INTENT OF AB5000 SYSTEM THERAPY IS TO PROVIDE CIRCULATORY SUPPORT, RESTORE NORMAL HEMODYNAMICS, REDUCE VENTRICULAR WORK, AND ALLOW THE HEART TIME TO RECOVER ADEQUATE MECHANICAL FUNCTION. THE AB5000 VENTRICLE IS EXTERNAL TO THE PATIENT AND IS INTENDED FOR SHORT-TERM USE.  APPROPRIATE PATIENT GROUPS INCLUDE THOSE THAT ARE LIKELY TO RECOVER CARDIAC FUNCTION AFTER THE MYOCARDIUM IS PERMITTED TO REST ON VENTRICULAR SUPPORT. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO: 1) PATIENTS WHO FAIL TO WEAN FROM CARDIOPULMONARY BYPASS FOLLOWING HEART SURGERY.  2) FAILED TRANSPLANT PATIENTS WHO REQUIRE VENTRICULAR ASSIST FOLLOWING HEART TRANSPLANTATION.  3) PATIENTS WHO REQUIRE RIGHT HEART ASSIST (RVAD) SUPPORT WHILE ON IMPLANTABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD).  4) PATIENTS SUFFERING FROM ACUTE CARDIAC DISORDERS SUCH AS VIRAL MYOCARDITIS.  A PATIENT IS A CANDIDATE FOR MECHANICAL ASSISTANCE WITH THE AB5000 SYSTEM IF SHE/HE MEETS ALL OF THE FOLLOWING CRITERIA: A) PATIENT HAS A BODY SURFACE AREA > 1.3 M(SQUARED) AND IS <= 75 YEARS OF AGE.  B) PATIENT IS IN RELATIVELY GOOD HEALTH OTHER THAN THE CARDIOVASCULAR PROBLEM FOR WHICH SURGERY WAS UNDERTAKEN.  C) ALL APPROPRIATE MEASURES HAVE BEEN ATTEMPTED TO CORRECT LOW ARTERIAL PH, ARTERIAL BLOOD GAS ABNORMALITIES, ELECTROLYTES, HYPOVOLEMIA, HYPERVOLEMIA, INADEQUATE CARDIAC RATE, DYSRHYTHMIAS, AND RESIDUAL HYPOTHERMIA.D) CARDIAC RESUSCITATION EMPLOYING PHARMACOLOGIC AGENTS HAS BEEN ATTEMPTED. WHILE THE USE OF THE INTRA-AORTIC BALLOON PUMP (IABP) IS RECOMMENDED PRIOR TO...
P900061|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2003|02/25/2003|||APPR|APPROVAL FOR THE MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) WHICH ARE INDICATED FOR USE BY THE PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P980016|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2003|02/25/2003|||APPR|APPROVAL FOR THE MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) WHICH ARE INDICATED FOR USE BY THE PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P980035|S026|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2003|02/25/2003|||APPR|APPROVAL FOR THE MODEL 2490D/E CARELINK MONITORS AND THE SERVER-BASED MODEL 2491 DEVICE DATA MANAGEMENT SOFTWARE APPLICATION (DDMA) WHICH ARE INDICATED FOR USE BY THE PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P980012|S005|WORLD HEART, INC.|7799 PARDEE LN.||OAKLAND|CA|94621||Ventricular (assisst) bypass|NOVACOR N100PCQ LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2003|01/02/2004|||APPR|APPROVAL FOR SEVERAL SPECIFIC ENGINEERING ENHANCEMENTS TO THE IMPLANTED (PUMP/DRIVE UNIT, BLOOD CONDUITS, AND PERCUTANEOUS LEAD) COMPONENTS OF THE NOVACOR N100PC LVAS SYSTEM AS WELL AS MODIFICATIONS TO THE SOFTWARE TO UPGRADE TO THE N100PCQ LVAS SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NOVACOR N100PCQ LVAS SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FUNCTION FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL.
P010031|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2003|07/21/2003|||APPR|APPROVAL FOR THE INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE.  THE SYSTEM AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSYNC II MARQUIS AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35 PERCENT AND A QRS DURATION GREATER THAN OR EQUAL TO 130 MS.
P980023|S012|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|KENTROX RV-S/KENTROX SL-S ICD LEADS|DTA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2003|11/18/2003|||APPR|APPROVAL FOR THE KENTROX RV-S AND KENTROX SL-S LEADS.
P000020|S008|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER, STINGER S, STINGER M, AND STINGER SM ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2003|02/26/2003|||OK30|CHANGE IN THE PACKAGING FOR THE BARD STINGER, STINGER S, STINGER M, AND STINGER SM ABLATION CATHETERS.
P820060|S017|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|AFP CONTROL PACK|LOJ|IM|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2003|03/05/2003|||APPR|APPROVAL FOR INITIATING HEAT STRESS REFERENCE TESTING FOR THE PLASMA DIAGNOSTIC BASE (PDB; CONTROL DILUENT) USED IN THE PREPARATION OF THE CONTROLS FOR THE AFP ASSAYS.
P000014|S005|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2003|02/24/2003|||OK30|CHANGE IN THE ACCEPTANCE CRITERIA FOR SPECIFIC ACTIVITY APPLIED TO THE RAW MATERIAL HEPATITIS B SURFACE ANTIGEN SUB-TYPE AD FROM >3.0 X 10(5) PEI U/MG TO >=2.85 X 10(5) PEI U/MG.
P020004|S003|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2003|04/22/2003|||APPR|APPROVAL FOR A CHANGE IN THE PACKAGING AND STERILIZATION CYCLE.
P910001|S023|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM|LPC|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/31/2003|05/02/2003|||APPR|APPROVAL FOR THE REVISED INSTRUCTIONS FOR USE THAT INCLUDE THE ADJUDICATED RESULTS FROM THE LARS INVESTIGATION.
P980007|S003|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ABBOTT IMX FREE PSA|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2003|02/05/2004|||APPR|APPROVAL FOR MODIFICATION OF THE ABBOTT ARCHITECT FREE PSA REAGENTS TO BE USED WITH THE IMX FREE PSA AND IS INDICATED FOR:  THE IMX FREE PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM.  THE IMX FREE PSA ASSAY IS INTENDED TO BE USED IN CONJUNCTION WITH THE IMX TOTAL PSA ASSAY IN MEN AGED 50 YEARS OR OLDER WITH TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND NON-SUSPICIOUS DRE TO DETERMINE THE % FREE PSA VALUE.  THE IMX % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE.
P910007|S009|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ABBOTT IMX TOTAL PSA|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2003|02/02/2004|||APPR|APPROVAL FOR THE ABBOTT IMX TOTAL PSA ASSAY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT IMX TOTAL PSA ASSAY AND IS INDICATED AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN AGED 50 YEARS OR OLDER.  PROSTATIC BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER.
P020009|S006|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 MR/OTW CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Express GMP Supplement|N|01/30/2003|03/12/2003|||APPR|APPROVAL FOR AN ALTERNATE FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND, LTD. (BSIL), GALWAY, IRELAND FOR THE MANUFACTURE OF THE STENT COMPONENT OF THE STENT SYSTEM.
P980009|S012|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT ENDOPROSTHESIS                                     SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2003|02/26/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO TRANSFER SEVERAL PRODUCTION STEPS TO AN ALTERNATE SET OF PRODUCTION EQUIPMENT & RE-ORDERING THE MANUFACTURING PROCESS SEQUENCE AND ELIMINATING DUPLICATE INSPECTION CHECKS.
P000013|S001|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEONICS ABC/TRIDENT SYSTEMS|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2003|03/17/2003|||APPR|APPROVAL FOR THE FOLLOWING ITEMS:  1) USE OF THE TRIDENT ACETABULAR SYSTEM WITH V40 ALUMINA HEADS AND ADDITIONAL C-TAPER ALUMINA HEAD SIZES (AND ASSOCIATED STEMS)  2) USE OF THE TRIDENT ACETABULAR SYSTEM WITH V40/C-TAPER AND MORSE TAPER ADAPTER SLEEVES (AND ASSOCIATED FEMORAL STEMS)  3) USE OF ADDITIONAL STYLES OF TRIDENT ACETABULAR SHELLS; AND  4) ASSOCIATED LABELING CHANGES DUE TO MODIFICATIONS IDENTIFIED ABOVE.
P010012|S009|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EASYTRAK 3 PACING LEAD|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2003|03/25/2003|||APPR|APPROVAL FOR TITANIUM OXIDE-IMPREGNATED SUTURE SLEEVE AND IS INDICATED FOR USE WITH GUIDANT EASYTRAK LEADS.
P020009|S007|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2003|03/07/2003|||OK30|MANUFACTURING CHANGE IN THE FINAL CLEANING PROCEDURE FOR THE STENT COMPONENT OF THE EXPRESS/EXPRESS2 CORONARY STENT SYSTEM.
P990020|S012|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|THE ANEURX STENT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2003|06/19/2003|||APPR|APPROVAL FOR THE MODIFICATION TO THE MANUFACTURING PROCESS TO ALLOW THE ANEURX STENT GRAFT TO BE UNLOADED AND RELOADED INTO A NEW PMA-APPROVED DELIVERY SYSTEM.
P900056|S076|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2003|03/07/2003|||OK30|MODIFICATION OF THE PROCESSING PARAMETERS WITHIN THE SAME STERILIZATION FACILITY.
P950037|S031|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|CARDIOMESSENGER HOME MONITORING SYSTEM|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2003|02/25/2003|||APPR|APPROVAL FOR OPTIMIZED CIRCUITRY, UPGRADED MODEM, UPGRADED BATTERY, AND AESTHETIC CHANGES.
P000018|S030|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE TM BETA-CATH TM SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2003|02/26/2003|||OK30|ALTERNATE METHOD OF MANUFACTURE FOR THE LEAK TESTING AND DRYING OPERATION OF THE BETA-RAIL 3.5F DELIVERY CATHETER.
P990075|S010|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2003|03/07/2003|||OK30|USE OF A LASER TO ENGRAVE THE MENTOR NAME, LOGO, DEVICE LOT NUMBER, AND DEVICE VOLUME ONTO THE PATCH ON THE SHELL OF THE SALINE FILLED BREAST IMPLANTS.
P990020|S013|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|02/07/2003|05/23/2003|||APPR|APPROVAL OF MODIFICATIONS TO THE POST-APPROVAL STUDY FOR THE DEVICE.
P830037|S048|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/6 NIGHTS (SPHERICAL|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2003|03/06/2003|||APPR|APPROVAL FOR THE FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENS INDICATED FOR EXTENDED WEAR UP TO 6 NIGHTS/7 DAYS.  THIS DEVICE WILL BE AN OPTIMIZED COMBINATION OF TWO OF THE PREVIOUSLY APPROVED PROCESSES; NAMELY, CURRENT FRESHLOOK COLORBLENDS (MULTIPLE PRINT) PRINTING PROCESS (P830037/S045) AND THE FRESHLOOK HANDLING TINT MONOMER TINTING PROCESS (830037/S039).  THIS ADDITIONAL PROCESS OF PRINTING ONTO A TINTED LENS FOR THE FRESHLOOK (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FAMILY OFFERS THE PATIENT A CONTACT LENS OPTION WITH A BETTER CONTRAST IN THE PRINTED PORTION OF THE LENS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FRESHLOOK TRADE NAME WITH THE FOLLOWING INDICATION:  FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 2.0 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE.  FRESHLOOK TORIC (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 6.0 DIOPTERS.  THE LENS ACTS TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE.  THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR IN NOT-APHAKIC PERSONS FROM 1-7 DAYS BETWEEN REMOVAL FOR CLEANING AND DISINFECTION OR DISPOSAL, AS RECOMMENDED BY THE EYE CARE PRACTITIONER.  THE EYE CARE PRACTITIONER MAY PRESCRIBE THE LENS IN EITHER A SINGLE USE DISPOSABLE PROGRAM OR IN A FREQUENT REPLACEMENT PROGRAM WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT.  WHEN PRESCRIBED IN A FREQUENT REPLACEMENT PROGRAM, THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM.  FRESHLOOK SOFT CONTACT LENSES WITH UV ABSORBING MONOMER HELP PROTECT...
P910023|S065|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/2003|04/23/2003|||APPR|APPROVAL FOR THE EPIC PLUS DR/VR DEVICE WITH MODEL 3307 VERSION 4.3A PROGRAMMER SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-196 AND V-236) AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  THE PROGRAMMER SOFTWARE MODEL 3307 VERSION 4.3A SUPPORTS ST. JUDE MEDICAL'S BRADYCARDIA AND TACHYCARDIA PULSE GENERATORS.
P880086|S092|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/2003|04/23/2003|||APPR|APPROVAL FOR THE MODEL 3307 VERSION 4.3A PROGRAMMER SOFTWARE.
P830045|S084|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|KRG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/07/2003|04/23/2003|||APPR|APPROVAL FOR THE MODEL 3307 VERSION 4.3A PROGRAMMER SOFTWARE.
P990017|S038|Boston Scientific Corp.|4100 Hamline Avenue North||St. Paul|MN|55112||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANCURE SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|02/10/2003|08/08/2003|||APPR|APPROVAL FOR THE FORMAT TO BE USED FOR THE CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIANS USERS AT LEAST ANNUALLY.  THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT.
P000052|S017|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS|MOU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/10/2003|04/09/2003|||APPR|APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, SOFTWARE VERSION 63-0033/M.
P910001|S024|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS|LPC|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/10/2003|08/08/2003|||APPR|APPROVAL FOR CHANGES TO INSTRUCTIONS FOR USE, INCLUDING CHANGES TO THE CONTRAINDICATIONS SECTION, FOR THE VITESSE COS RX, VITESSE E, AND EXTREME OTW CATHETERS.
P010038|S003|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|ICAD|MYN|RA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2003|03/06/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ICAD, INC. NASHUA, NEW HAMPSHIRE.
P000009|S008|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS A+ /BELOS A+/T, /KAINOX A+ 75/15, /KAINOX A+ 75/17|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/10/2003|03/19/2004|||APPR|APPROVAL FOR THE BELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM).  IT IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P920014|S019|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE XVE LVAS|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|02/07/2003|06/29/2004|||APPR|APPROVAL OF THE POST APPROVAL STUDY FOR THE DEVICE.
P960030|S010|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ISOFLEX S PERMANENT PACING LEAD MODELS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2003|04/10/2003|||APPR|APPROVAL FOR REDUCED LEAD BODY SIZE FOR THE PASSIVE PLUS DX LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOFLEX S AND IS INDICATED FOR USE IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM (MODELS 1643K AND 1642T) OR VENTRICLE (MODELS 1645K AND 1646T).
P960016|S009|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2003|03/28/2003|||APPR|APPROVAL FOR REVISED INDICATIONS FOR USE FOR THESE MODELS OF LIVEWIRE TC ABLATION CATHETERS: 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH UNIVERSAL SENSOR (MODELS 402205-402208); 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH THERMISTOR (MODELS 402209-402212); 5MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETERS XLS WITH THERMOCOUPLE (MODELS 402213-402216); 4MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETHER WITH THERMISTOR (MODELS 402229-402232); AND 4MM LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER XLS WITH THERMISTOR (MODELS 402233-402236).  THE CATHETERS ARE INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
P990074|S014|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|MCGHAN SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2003|03/12/2003|||APPR|APPROVAL TO MANUFACTURE MCGHAN SALINE-FILLED BREAST IMPLANTS, STYLES 168, 163, 363LF, AND 468 AT INAMED CORPORATION'S FACILITY LOCATED IN BARREAL DE HEREDIA, COSTA RICA.
P950019|S013|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY TFC UNITE PRODUCT LINE|MAX|OR|Normal 180 Day Track No User Fee|Express GMP Supplement|N|02/13/2003|07/15/2003|||APPR|APPROVAL FOR NEW MANUFACTURING FACILITIES FOR THE RAY TFC UNITE PRODUCT LINE.  THE FACILITIES ARE LOCATED AT CENTERPULSE SPINE-TECH, MINNEAPOLIS, MINNESOTA AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MINNESOTA.
P950019|S014|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY TFC AND RAY TFC UNITE|MAX|OR|Normal 180 Day Track No User Fee|Express GMP Supplement|N|02/13/2003|03/25/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRYKER SPINE, CESTAS, FRANCE.
P000041|S001|RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|RAPIDSCREEN RS-2000D|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/13/2003|06/30/2003|||APPR|APPROVAL FOR THE ADDITION OF THE ABILITY OF THE RAPIDSCREEN RS-2000D TO PROCESS DIGITAL IMAGES IN ADDITION TO FILM/SCREEN IMAGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RAPIDSCREEN RS-2000D AND IS INDICATED FOR:  THE RS-2000D IS A COMPUTER-AIDED DETECTION (CAD) SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON DIGITAL OR DIGITALIZED FRONTAL CHEST RADIOGRAPHS.  IT IDENTIFIES FEATURES ASSOCIATED WITH SOLITARY PULMONARY NODULES FROM 9 TO 30 MM IN SIZE, WHICH COULD REPRESENT EARLY-STAGE LUNG CANCER.  THE DEVICE IS INTENDED FOR THE USE AS AN AID ONLY AFTER THE PHYSICIAN HAS PERFORMED AN INITIAL INTERPRETATION OF THE RADIOGRAPH.
P000018|S031|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH 3.5 SYSTEM|MOU|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2003|03/17/2003|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING PROCESS OF THE BETA-RAIL 3.5F DELIVERY CATHETER.
P940015|S009|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC (HYLAN G-F 20)|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/2003|03/14/2003|||APPR|APPROVAL FOR THE ADDITION OF THE FOLLOWING PRECAUTION STATEMENT TO THE SYNVISC PHYSICIAN PACKAGE INSERT:  "TWIST THE GRAY TIP CAP BEFORE PULLING IT OFF, AS THIS WILL MINIMIZE PRODUCT LEAKAGE".
P930029|S020|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|MEDTRONIC ATAKR II MODEL 4802 (60W) SOFTWARE VERSION 1.36|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2003|03/03/2003|||APPR|APPROVAL FOR A SOFTWARE UPGRADE (VERSION 1.36) FOR THE MEDTRONIC ATAKR II MODEL 4802 (60SW) RADIO FREQUENCY GENERATOR.
P950018|S009|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2003|03/20/2003|||APPR|APPROVAL FOR A NEW STABILITY PROTOCOL THAT WILL EXTEND THE EXPIRATION DATING FOR PERFLUORON FROM 2 YEARS TO UP TO 4 YEARS FOR THE CURRENTLY APPROVED PRODUCT CONFIGURATION, WITH STABILITY TESTING DATA REPORTED VIA ANNUAL REPORTS IN THE FUTURE.
P950039|S010|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2003|03/27/2003|||APPR|APPROVAL FOR LABELING CHANGES FOR THE PRESERVCYT SOLUTION AS AN ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTICS COBAS AMPLICOR CT/NG TEST.
P010001|S001|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/20/2003|04/04/2003|||APPR|APPROVAL FOR THE ADDITION OF THE LINEAGE ACETABULAR SHELL TO BE USED WITH THE TRANSCEND CERAMIC LINERS.
P010033|S003|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB|NCD|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/2003|03/17/2003|||APPR|APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE THAT ENHANCE THE SAFE USE OF THE QUANTIFERON-TB BY INCORPORATING RECOMMENDATIONS FROM THE "CDC GUIDELINES FOR USING THE QUANTIFERON-TB TEST FOR DIAGNOSING LATENT MYCOBACTERIUM TUBERCULOSIS INFECTION" (MMWR DISPATCH, VOL. 51/DECEMBER 18, 2002).
P990001|S014|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON DA+ C SERIES PULSE GENERATORS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/20/2003|09/16/2003|||APPR|APPROVAL FOR MODIFICATIONS TO RATE RESPONSE FEATURES, ADDITION OF TELEMETRY B, AND OTHER DIAGNOSTIC ENHANCEMENTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/VITATRON DA+ C-SERIES IMPLANTABLE GENERATORS AND IS INDICATED AS FOLLOWS:   1)   DUAL CHAMBER PACING IS INDICATED IF AV SYNCHRONY NEEDS TO BE RESTORED IN ORDER TO OPTIMIZE CARDIAC OUTPUT. FOR EXAMPLE, PATIENTS WITH SYMPTOMATIC SECOND OR THIRD DEGREE AV BLOCK.  2) DUAL CHAMBER RATE RESPONSIVE PACING MODES ARE OF SPECIFIC BENEFIT TO PATIENTS WITH CHRONOTROPIC INCOMPETENCE OF THE SINUS NODE.  3) RATE RESPONSIVE MODES CAN HELP PATIENTS WHO HAVE A REQUIREMENT FOR ANINCREASE IN PACING RATE IN RESPONSE TO PHYSICAL ACTIVITY. 4) SINGLE CHAMBER VENTRICULAR PACING CAN HELP PATIENTS WITH PERMANENT ATRIALTACHYARRHYTHMIAS, INCLUDING ATRIAL FIBRILLATION AND FLUTTER.  5) SINGLE CHAMBER ATRIAL PACING CAN HELP PATIENTS WITH SYMPTOMATIC BRADYARRHYTHMIASAND NORMAL AV CONDUCTION.
P920014|S020|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE STROKE VOLUME LIMITER|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2003|03/21/2003|||APPR|APPROVAL FOR SPECIFIC ADDITIONAL SAFETY INSTRUCTIONS TO THE LABELING FOR THE STROKE VOLUME LIMITER.
P010049|S005|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2003|03/12/2003|||APPR|APPROVAL FOR TWO LABELING ADDITIONS TO THE APPROVED PREMARKET APPROVAL APPLICATION.
P000052|S018|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2003|03/20/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR GUIDANT'S P-32 SOURCE WIRE.
P970020|S043|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ACS MULTI-LINK DUET CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2003|07/22/2003|||APPR|APPROVAL TO CHANGE THE POST-APPROVAL REQUIREMENT PERIOD FROM 5 TO 4 YEARS AND TO UPDATE THE LABELING WITH CLINICAL DATA FROM 4 YEAR FOLLOW-UP.
P990037|S014|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2003|03/14/2003|||APPR|APPROVAL FOR AN ADDITIONAL INCOMING INSPECTION REQUIREMENT TO MEASURE THE OUTER DIAMETER (OD) OF THE DISTAL END OF THE STOPCOCK AND TO TIGHTEN THE TOLERANCE AROUND THE ORIGINALLY APPROVED OD ON THE STOPCOCK DISTAL END.
P010019|S002|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS|LPM|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/24/2003|03/19/2003|||APPR|APPROVAL FOR THE FOLLOWING INDICATION:  NIGHT & DAY SOFT CONTACT LENSES ARE ALSO INDICATED FOR THERAPEUTIC USE.  USE AS A BANDAGE TO PROTECT THE CORNEA AND TO RELIEVE CORNEAL PAIN DURING THE TREATMENT OF ACUTE OR CHRONIC OCULAR PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL EROSIONS, ENTROPION, CORNEAL EDEMA, AND CORNEAL DYSTROPHIES AS WELL AS POST-SURGICAL CONDITIONS RESULTING FROM CATARACT EXTRACTION AND CORNEAL SURGERY.  NIGHT & DAY SOFT CONTACT LENSES FOR THERAPEUTIC USE CAN ALSO PROVIDE OPTICAL CORRECTION DURING HEALING IF REQUIRED.
P990075|S011|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED BREAST IMPLANT|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2003|03/26/2003|||OK30|CHANGE FOR ALTERNATIVE CALENDARING EQUIPMENT AN DAN ALTERNATIVE MATERIAL SUPPLIER FOR THE SILICONE SHEETING.
P960025|S010|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|LUMBAR I/F CAGE SYSTEM|MCV|OR|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2003|03/17/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT DEPUY ACROMED SARL, LELOCLE, SWITZERLAND.
P010040|S002|RedHawk Medical Products & Services LLC|P.O. Box 53929||Lafayette|LA|70505|3929|Device, needle destruction|DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE|MTV|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/2003|04/04/2003|||APPR|APPROVAL FOR CLINICAL USE OF THE DEVICE, THE COMPONENTS AND SHIELDING TO MINIMIZE EMI LEVELS, A HIGHER CURRENT CAPACITY FOR AC OPERATION AND TWO ADAPTERS TO ACCOMMODATE DESTRUCTION OF CONVENTIONAL NEEDLES RANGING IN SIZE FROM 5/16 TO 1 INCH IN LENGTH AND 20-30 GAUGE THAT ARE ATTACHED TO 1 TO 3 CC SYRINGES.  THE DEVICE, AS MODIFIED, WHICH WILL BE MARKETED UNDER THE TRADE NAME DISINTEGRATOR PRO, IS A SHARPS NEEDLE DESTRUCTION DEVICE FOR CLINICAL USE THAT IS INDICATED FOR THE DESTRUCTION OF LANCETS AND 20 TO 30 GAUGE NEEDLES FORM 5/16 TO 1 INCH IN LENGTH.
P950034|S023|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER & SEPRAFILM PROCEDURE PACK|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2003|03/25/2003|||OK30|THE RETURN OF DISTRIBUTION ACTIVITIES FOR SEPRAFILM ADHESION BARRIER AND SEPRAFILM PROCEDURE PACK TO THE FRAMINGHAM, MASSACHUSETTS, MANUFACTURING FACILITY.
P010034|S003|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2003|08/11/2003|||APPR|APPROVAL FOR THE SECOND LOOK DIGITAL CAD SYSTEM FOR GEMS SENOGRAPHIE 2000D FULL FIELD DIGITAL MAMMOGRAPHY.  THE CHANGES INCLUDE SOFTWARE UPGRADE TO ACCOMMODATE DIGITAL IMAGE PROCESSING AND AN ADDITION OF RACK MOUNTABLE HARDWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY AND IS INDICATED FOR IDENTIFICATION AND MARKING REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM GENERAL ELECTRIC MEDICAL SYSTEMS SENOGRAPHIE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.
P010033|S004|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM|NCD|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2003|08/07/2003|||APPR|APPROVAL FOR THE USE OF THE QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM FOR USE WITH THE QUANTIFERON-TB TEST.  THE DEVICE ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON-TB  ANALYSIS SOFTWARE PROGRAM AND IS INDICATED AS A STAND ALONE PROGRAM FOR ANALYSIS OF RAW EIA DATA AND CALCULATION OF QUANTIFERON-TB ASSAY RESULTS.
P950037|S032|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/2003|03/31/2004|||APPR|APPROVAL FOR ADDING AXVX ADAPTIVE RATE PACING CAPABILITY TO THE PROTOS FAMILY OF PULSE GENERATORS, THE ADDITION OF THE DATA TRANSFER UTILITY SOFTWARE, AND MODIFICATIONS TO THE AXIOS FAMILY OF PULSE GENERATORS.
P960043|S044|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2003|04/04/2003|||APPR|APPROVAL TO: REPLACE THE BRAINED SUTURE WITH A MONOFILAMENT POLYPROPYLENE SUTURE; COMBINE THE INSTRUCTIONS FOR USE OF THE PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CHITO-SEAL DEVICE INTO A SINGLE PAMPHLET.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 8 FR. SHEATHS.  THE PERCLOSE A-T MONOFILAMENT 6 FR. SMC SYSTEM REDUCES THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS.
P980023|S013|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||TESTER, PACEMAKER ELECTRODE FUNCTION|KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18|DTA|CV|Normal 180 Day Track|Postapproval Study Protocol - ODE/OIR|N|02/19/2003|07/29/2003|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P880086|S093|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2003|03/20/2003|||APPR|APPROVAL FOR THE IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A.  THESE DEVICES ARE INDICATED AS FOLLOWS:  IMPLANTATION OF IDENTITY ADX MODELS5386 AND 5380 PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS.  DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME, CHRONIC SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK, RECURRENT ADAMS-STOKES SYNDROME, AND SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARREST, CHRONIC ATRIAL FIBRILLATION AND SEVERE PHYSICAL DISABILITY.  AF SUPPRESSION IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P000018|S032|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH 3.5 SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2003|03/13/2003|||OK30|ALTERNATE METHOD OF MANUFACTURE OF THE BETA-CATH 3.5F SYSTEM FLUSHING ADAPTER.
P830045|S085|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2003|03/20/2003|||APPR|APPROVAL FOR THE IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A.  THESE DEVICES ARE INDICATED AS FOLLOWS:  IMPLANTATION OF IDENTITY ADX MODELS5386 AND 5380 PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS.  DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME, CHRONIC SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK, RECURRENT ADAMS-STOKES SYNDROME, AND SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARREST, CHRONIC ATRIAL FIBRILLATION AND SEVERE PHYSICAL DISABILITY.  AF SUPPRESSION IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P910023|S066|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2003|03/20/2003|||APPR|APPROVAL FOR THE IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A.  THESE DEVICES ARE INDICATED AS FOLLOWS:  IMPLANTATION OF IDENTITY ADX MODELS5386 AND 5380 PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS.  DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME, CHRONIC SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK, RECURRENT ADAMS-STOKES SYNDROME, AND SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARREST, CHRONIC ATRIAL FIBRILLATION AND SEVERE PHYSICAL DISABILITY.  AF SUPPRESSION IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P960022|S003|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2003|04/04/2003|||APPR|APPROVAL FOR A TORIC DESIGN WITH AN EXTENDED WEAR INDICATION FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR THE ABOVE REFERENCED DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB SOFLENS66 TORIC (ALPHAFILCONA) VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 5.00 DIOPTERS (D) THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00 D TO -9.00D WHEN PRESCRIBED FOR USE TO 7 DAYS OF EXTENDED WEAR.
P900009|S017|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM|LPQ|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2003|04/22/2003|||APPR|APPROVAL FOR THE ADDITION OF A NEW CIRCUIT BOARD INSPECTION STEP FOR THE EXOGEN 2000+ DEVICE.
P830061|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE SP/SENSE/SP NOVUS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2003|04/03/2003|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF POLYETHERURETHANE.
P850089|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE SP NOVUS/Z NOVUS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2003|04/03/2003|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF POLYETHERURETHANE.
P920015|S027|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT/SPRINT QUATTRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2003|04/03/2003|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF POLYETHERURETHANE.
P930039|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE FIX/NOVUS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2003|04/03/2003|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF POLYETHERURETHANE.
P980016|S034|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2003|04/03/2003|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF POLYETHERURETHANE.
P910073|S041|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/2003|11/04/2003|||APPR|APPROVAL TO MODIFY THE ACTIVE AND PASSIVE FIXATION ENDOTAK FAMILY OF DEFIBRILLATION LEADS AND TO PACKAGE THE LEADS WITH A TRANSVALVULAR INSERTION TOOL FOR USE WITH A HEMOSTATIC INTRODUCER.  THE LEADS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK RELIANCE G ENDOCARDIAL DEFIBRILLATION LEAD, MODELS 0164, 0165, 0166, 0167, 0174, 0175, 0176, 0177 AND ENDOTAK RELIANCE SG ENDOCARDIAL DEFIBRILLATION LEAD, MODELS 0160, 0161, 0162, 0163.
P010022|S002|ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2003|03/18/2003|||APPR|APPROVAL FOR A LABELING CHANGE TO ADD A BOXED WARNING REGARDING SWELL VOLUMES OF THE SEALANT.
P960016|S010|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2003|08/20/2004|||APPR|APPROVAL FOR MODIFYING THE MANUFACTURING CLEANING SOLVENT; AND CLEANING AND RESTERILIZATION OF THE CABLES UP TO TEN (10) TIMES IN EITHER A STERRAD 100S GAS PLASMA STERILIZER OR UP TO TEN (10) TIMES WITH ETO GAS STERILIZER USING THE CYCLE PARAMETERS SPECIFIED IN THE INSTRUCTIONS FOR USE.
P010015|S009|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III MODEL 8042 ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE|LWP|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2003|03/27/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC B.V., EUROPEAN OPERATIONS CENTER, HEERLEN, THE NETHERLANDS.  FINAL DEVICE PACKAGING WILL BE PERFORMED AT THIS FACILITY.
P000044|S003|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK/ CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2003|03/20/2003|||OK30|ADDITION OF RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS.
P000043|S005|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2003|03/19/2003|||APPR|APPROVAL TO CHANGE THE MANUFACTURING SITE FOR THE FINAL PRODUCT ACCEPTANCE FOR THE RX-200 TREATMENT CATHETER TO MANUFACTURING AND RESEARCH, INC., TUCSON, ARIZONA.
P980053|S006|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE EXP|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2003|08/26/2003|||APPR|APPROVAL FOR A MODIFIED BEAD SPECIFICATION (90-212 UM) FOR THE PYROLYTIC CARBON COATED ZIRCONIUM OXIDE AND GRAPHITE BEADS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DURASPHERE EXP AND IS INDICATED FOR USE IN THE TREATMENT OF ADULT WOMEN WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).
P970004|S024|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2003|04/01/2003|||APPR|APPROVAL TO LIMIT USE OF THE MODEL 8870 APPLICATION CARD TO ONLY THE INTERSTIM AND ENTERRA APPLICATIONS BY MODIFYING THE DESKTOP SOFTWARE, TO REMOVE THE MODEL 8529 MAGNET USED WITH THE SYNCHROMED DRUG PUMP APPLICATION FROM THE PROGRAMMING UNIT, AND TO MODIFY THE LABELING TO REFLECT THESE CHANGES.
P870072|S025|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VAD SYSTEM; SEALED ARTERIAL CANNULAE, 14 MM AND 18 MM GRAFT|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/2003|04/25/2003|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE ARTERIAL CANNULAE USED WITH THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE.
P000025|S008|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2003|03/25/2003|||APPR|APPROVAL FOR THE FOLLOWING CHANGES IN THE LABELING:  1) INFORMATIONAL STATEMENTS REGARDING MENINGITIS, THE USE OF PROPHYLACTIC ANTIBIOTICS, AND VACCINATIONS  2) INFORMATIONAL STATEMENTS REGARDING ELECTROSTATIC DISCHARGE (ESD) PREVENTIONS.
N18286|S014|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM ABORBABLE GELATIN SPONGE|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2003|04/21/2003|||APPR|APPROVAL FOR MODIFIED LABELING DISCUSSING THE USE OF GELFOAM WITH BOVINE THROMBIN.
P980023|S014|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|CARDIAC AIRBAG / CARDIAC AIRBAG-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/2003|05/14/2003|||APPR|APPROVAL FOR THE CARDIAC AIRBAG AND CARDIAC AIRBAG-AT AND ARE INTENDED TO PROVIDE VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING ARRHYTHMIAS IN INDIVIDUALS NOT EXPECTED TO HAVE GREATER THAN 3 EPISODES OF VENTRICULAR ARRHYTHMIAS REQUIRING ICD THERAPY DURING THE ANTICIPATED LIFETIME OF THE DEVICE.
P990037|S015|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT PRO SEALING DEVICE (MODEL 1010) AND DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210)|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/11/2003|05/20/2003|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE DEUTT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE.
P020014|S002|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|03/11/2003|07/01/2003|||APPR|APPROVAL FOR A CHANGE TO THE ANCHORING OF THE PROXIMAL LONGITUDINAL POLYETHYLENE TEREPTHALATE (PET) FIBERS ON THE IMPLANT.
P980033|S006|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/12/2003|04/01/2003|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) MANUAL, NAMELY A MODIFICATION TO THE SIZING REQUIREMENTS OF THE INTRODUCER SHEATHS AND A MODIFICATION TO THE DESCRIPTION OF THE RECOMMENDED GUIDE WIRE TO BE USED WITH THE WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM.
P010012|S010|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EASYTRAK LEAD MODELS IS-1 4535/4536/4537/4538 CORONARY VENOUS STEROID-ELUTING SINGLE-ELECTRODE PACE/SENSE LEAD|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2003|06/13/2003|||APPR|APPROVAL FOR CHANGE FROM A LV-1 LEAD CONNECTOR TO AN IS-1 LEAD CONNECTOR DESIGN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EASYTRAK IS-1 LEAD, AND IS INDICATED FOR CHRONIC LEFT VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE.
P020014|S003|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/13/2003|04/11/2003|||APPR|APPROVAL FOR LABELING CHANGES TO ADDRESS THE DIFFICULTY/FAILURE TO DISENGAGE OR DETACH THE DELIVERY WIRE FROM THE ESSURE MICRO-INSERT AND LABELING CHANGES TO STRENGTHEN THE RECOMMENDATION REGARDING USE OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) PRIOR TO THE ESSURE PROCEDURE.
P920004|S019|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL DEVICES|MGB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2003|04/03/2003|||APPR|APPROVAL TO MOVE THE REMAINING CHEMICAL PROCESSING AND TEXTILING OPERATIONS FROM THE MANUFACTURING FACILITY IN VAALS, THE NETHERLANDS TO DATASCOPE'S FACILITY LOCATED IN MAHWAH, NEW JERSEY.
P960040|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY DS ICD SYSTEMS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/2003|07/10/2003|||APPR|APPROVAL FOR THE VITALITY DS VR MODEL T135, VITALITY DS MODEL T125, AND VITALITY EL MODEL T127 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY DS VR MODEL T135, VITALITY DS MODEL T125, AND VITALITY EL MODEL T127 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6, AND THE INDICATION FOR USE IS AS FOLLOWS:GUIDANT ICDS ARE INTENDED TO PROVIDE THERAPY FOR THE AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE  1)  THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR  2) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION OF <=30% (AS DEFINED IN APPENDIX E ).
P010012|S011|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD 2 CRT-D SYSTEMS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/2003|07/10/2003|||APPR|APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6
P960058|S030|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/18/2003|07/07/2003|||APPR|APPROVAL FOR THE REPACKAGED ICS (IMPLANTABLE COCHLEAR STIMULATOR), REFERRED TO AS HIRES 90K, AND ITS ASSOCIATED SURGICAL TOOLS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS AND THE PEDIATRIC POPULATION AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS OF AGE.
P960006|S008|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/20/2003|05/30/2003|||APPR|APPROVAL FOR CHANGE IN THE DUROMETER HARDNESS FROM 55D TO 70D.
P860047|S012|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT(2%HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2003|04/16/2003|||OK30|CHANGE IN THE FREQUENCY OF THE FOLLOWING INCOMING INSPECTION TESTS:  HPMC CONTENT, TOTAL CHLORIDES, OSMOLARITY, PARTICULATES, PROTEIN, DENSITY, HPMC VOLUME, PH AND VISCOSITY.
P950020|S008|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON ULTRA 2|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/2003|06/04/2003|||APPR|APPROVAL FOR A TWO YEAR SHELF LIFE FOR BOTH THE OVER-THE-WIRE (OTW) AND MONORAIL (MR) DEVICES.
P010043|S001|YAMA, INC.|P.O. BOX 884||MILLBURN|NJ|07041||CAP, CERVICAL, CONTRACEPTIVE|LEA'S SHIELD BARRIER CONTRACEPTIVE|LLQ|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2003|05/26/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT YAMA, INC., UNION, NEW JERSEY.
P840001|S067|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2003|05/09/2003|||APPR|APPROVAL FOR THE SNAP LID SCREENING CABLE, THE OCTAD PERCUTANEOUS EXTENSION AND THE OCTAD STYLET WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
P970018|S006|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN (TM) SYSTEM|MKQ|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/24/2003|05/02/2003|||APPR|APPROVAL TO MODIFY THE CURRENT APPROVED LABELING TO INCLUDE DATA AND INFORMATION FROM A DIRECT-TO-VIAL CLINICAL STUDY FOR HIGH GRADE SQUAMOUS INTRAEPITHELIAL AND MORE SEVERE LESIONS.
P010049|S006|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL II ARTERIAL CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2003|04/24/2003|||APPR|APPROVAL TO LENGTHEN THE APPROVED GUIDEWIRE FROM 55 CM TO 70 CM.
P990065|S001|SIRTEX MEDICAL LIMITED|UNIT F6 PARKVIEW 16 MARS ROAD||LANE COVE||NSW 2||Microspheres radionuclide|SIR-SPHERES|NAW|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/2003|04/24/2003|||APPR|APPROVAL FOR ADDITIONAL WARNING ON THE LABEL.
P860057|S021|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS,MODEL 6900P,MITRAL|DYE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/26/2003|04/18/2003|||APPR|APPROVAL FOR CHANGES TO THE WARNING AND PRECAUTION INFORMATION , AS WELL AS THE INSTRUCTIONS FOR THE USE OF THE DEVICE.
P950034|S024|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER AND SEPRAFILM PROCEDURE PACK|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2003|04/25/2003|||OK30|MANUFACTURING CHANGE BY THE ADDITION OF AN ALTERNATE RAW MATERIAL SUPPLIER OF HYALURONIC ACID (HA).
P010025|S002|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/28/2003|09/24/2003|||APPR|APPROVAL FOR THE FOLLOWING CHANGES IN THE SELENIA QC MANUAL:  1) CHANGE THE MINIMUM SCORES FOR THE ACR PHANTOM TEST TO 5 FIBERS, 4 SPECS, AND 4 MASSES FORM 4 FIBERS, 4 SPECS, AND 3 MASSES.  2) CHANGE THE SIGNAL-TO-NOISE TEST RESULT MINIMUM FROM 40 TO 35.  THE 40 VALUE WAS BASED ON THE USE OF THE BR-12 PHANTOM, WHEREAS THE STANDARD PHANTOM IS THE ACT WITH A MINIMUM VALUE OF 35.  3) ADD A SPECIFICATION OF 28 K VP AND 65 MAS FOR PERFORMANCE OF QC TESTING.
P000025|S009|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2003|08/27/2003|||APPR|APPROVAL FOR THE COMBI 40+ SYSTEM MEDIUM ACTIVE ELECTRODE ARRAY (C40+M) TO BE PART OF THE C40+ COCHLEAR IMPLANT SYSTEM (IMPLANT C40+ WITH STANDARD C40+, SPLIT C40+ GB, AND COMPRESSED C40+ S ELECTRODE ARRAYS).
P980035|S027|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|AT500DDDRP PACING SYSTEM & MODEL 9968 SOFTWARE|DXY|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2003|04/16/2003|||APPR|APPROVAL TO MOVE THE MANUFACTURING SITE FROM MEDTRONIC'S EUROPEAN OPERATIONS CENTER (EOC) IN KERKRADE, THE NETHERLANDS TO MEDTRONIC'S EOC, HEERLEN, THE NETHERLANDS.
P930038|S036|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/31/2003|05/02/2003|||APPR|APPROVAL FOR MODIFYING AND STANDARDIZING THE ABSORBABLE ANCHOR COMPONENT OF THE DEVICE SO THAT THE SAME COMPONENT COULD BE USED IN EITHER MARKETED PLATFORM.
P010031|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM|NIK|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|04/01/2003|04/24/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT EUROPEAN OPERATIONS CENTER, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.  FINAL DEVICE PACKAGING WILL BE PERFORMED AT THIS FACILITY.
P970035|S045|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S7 AND S660 ZIPPER MX CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2003|05/02/2003|||OK30|CHANGE TO THE ADHESION PROCESS FOR THE Z-COMPONENT IN THE MANUFACTURE OF THE DEVICES.
P900061|S056|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM MODEL 7227 ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/27/2002|04/16/2002|||APPR|APPROVAL FOR EXPANSION OF THE FUNCTIONALITY OF THE MODEL 2490A CARELINK MONITOR AND MODEL 2491 SOFTWARE, VERSION 1.0 TO INCLUDE THE GEM, GEM DR, GEM II VR, GEM II DR, GEM III VR AND GEM III DR IMPLANTABLE CARDIOVETER DEFIBRILLATORS.
P840001|S068|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/2003|05/09/2003|||APPR|APPROVAL FOR LABELING CHANGES TO PISCES Z QUAD LEAD TECHNICAL MANUALS AND A CHANGE TO THE NEEDLE IN THE PISCES Z QUAD LEAD KITS AND IN THE MODEL 3550-22 AND MODEL 3550-23 ACCESSORY KITS FROM 15 GAUGE TO THE 14 GAUGE.
P990042|S006|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/2003|06/30/2003|||APPR|APPROVAL FOR INCLUSION OF POST-APPROVAL STUDY RESULTS IN THE PACKAGE INSERT.
P990045|S004|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/2003|06/26/2003|||APPR|APPROVAL FOR THE REVISED PACKAGE INSERT.
P860004|S056|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/2003|09/12/2003|||APPR|APPROVAL FOR THE MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM WHICH INCLUDES MODEL 8637 SYNCHROMED II PROGRAMMABLE PUMP, SYNCHROMED II APPLICATION SOFTWAARE ON THE MODEL 8870 APPLICATION CARD, MODEL 8551 REFILL KIT, MODEL 8540 CATHETER ACCESS PORT KIT, AND MODEL 8590-1 POUCH KIT.
P990044|S003|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/09/2003|06/26/2003|||APPR|APPROVAL FOR THE REVISED PACKAGE INSERT.
P860047|S013|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT(2%HYDROXYPROPYLMETHLCELLULOSE SOLUTION)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2003|05/08/2003|||OK30|CHANGE IN THE STERILIZATION CYCLE PARAMETERS FOR OCUCOAT AS IT IS STERILIZED BY ABBOTT LABORATORIES.
P990043|S004|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/2003|06/26/2003|||APPR|APPROVAL FOR THE REVISED PACKAGE INSERT.
P810006|S021|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE AND FIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2003|05/05/2003|||OK30|CHANGES EFFECTING MANUFACTURING PROCESSES INCLUDING:  1) QUALIFYING ADDITIONAL SPACE IN THE SAME FACILITY FOR THE ENZYME TREATMENT PROCESS USING THE SAME DEDICATED EQUIPMENT,  2) EQUIPPING THE ALKALI TREATMENT PROCESSING VESSELS WITH A DEDICATED TEMPERATURE PROBE AND CHART RECORDER TO CONTINUOUSLY MONITOR AND RECORD PRODUCT IN THE VESSELS DURING PROCESSING,  3) USE OF AN ADDITIONAL MANUFACTURING AREA, AND  4) USING A MICROWAVE MOISTURE ANALYZER, INSTEAD OF A DRY HEAT OVEN, FOR DRYING THE WEIGHTED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.
P010021|S001|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2003|04/30/2003|||OK30|ADDITIONAL RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS.  THE ADDITIONAL SUPPLIER WILL BE TECH GROUP IRELAND.
P010015|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 4193 ATTAIN OTW LEAD|LWP|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2003|05/09/2003|||APPR|APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS.
P990039|S001|QUIDEL CORP.|2981 COPPER RD.||SANTA CLARA|CA|||Tester,acoustic,bone quality|QUS-2 CALCANEAL ULTRASONOMETER|NAN|RA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|04/14/2003|06/19/2003|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT PLEXUS EA, SEATTLE, BOTHELL, WA.
P880086|S094|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|IDENTITY ADX XL DC,& SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2003|05/09/2003|||APPR|APPROVAL FOR PULSE GENERATOR MODELS AND PROGRAMMER SOFTWARE MODEL 3307 V4.4A.
P830045|S086|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2003|05/09/2003|||APPR|APPROVAL FOR PULSE GENERATOR MODELS AND PROGRAMMER SOFTWARE MODEL 3307 V4.4A.
P910023|S067|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2003|05/09/2003|||APPR|APPROVAL FOR PULSE GENERATOR MODELS AND PROGRAMMER SOFTWARE MODEL 3307 V4.4A.
P990044|S004|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-CORE-IGMK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2003|05/07/2003|||OK30|CHANGE IN THE QUANTITY OF NON-SPECIFIC MOUSE IGG USED IN THE PREPARATION OF THE SAMPLE DILUENT, POSITIVE CONTROL AND NEGATIVE CONTROL KIT REAGENTS OF THE DIASORIN ETI-CORE-IGMK PLUS.
P890014|S005|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|DIASORIN ETI-HA-IGMK PLUS|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2003|05/06/2003|||OK30|CHANGE IN THE QUANTITY OF NON-SPECIFIC MOUSE IGG USED IN THE PREPARATION OF THE SAMPLE DILUENT, POSITIVE CONTROL AND NEGATIVE CONTROL KIT REAGENTS OF THE DIASORIN ETI-HA-IGMK PLUS.
P850010|S018|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE & FIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2003|05/05/2003|||OK30|CHANGES EFFECTING MANUFACTURING PROCESSES INCLUDING:  1) QUALIFYING ADDITIONAL SPACE IN THE SAME FACILITY FOR THE ENZYME TREATMENT PROCESS USING THE SAME DEDICATED EQUIPMENT,  2) EQUIPPING THE ALKALI TREATMENT PROCESSING VESSELS WITH A DEDICATED TEMPERATURE PROBE AND CHART RECORDER TO CONTINUOUSLY MONITOR AND RECORD PRODUCT IN THE VESSELS DURING PROCESSING,  3) USE OF AN ADDITIONAL MANUFACTURING AREA, AND  4) USING A MICROWAVE MOISTURE ANALYZER, INSTEAD OF A DRY HEAT OVEN, FOR DRYING THE WEIGHTED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.
P000039|S005|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER, AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2003|05/13/2003|||OK30|ALTERNATE SUPPLIER FOR THE END SCREW ATTACHMENT OF THE DEVICE AS WELL AS THE DELIVERY CABLE DISTAL END SCREW, AND PROXIMAL SCREW ATTACHMENT ON THE DELIVERY CABLE.
P850020|S017|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA COLUMN|LKN|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/2003|04/15/2004|||APPR|APPROVAL FOR LABELING CHANGES TO 1) ADD A PRECAUTION ABOUT THE USE OF PEDIATRIC ASPIRIN FOR RHEUMATOID ARTHRITIS (RA) PATIENTS DUE TO THE INCREASES RISK OF THROMBOSIS, AND 2) SPECIFY THE TREATMENT REGIMEN FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS SO THAT PATIENTS RECEIVE 6 TREATMENTS, 2-3 TIMES A WEEK FOR 2 OR 3 WEEKS.
P900033|S009|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2003|05/05/2003|||OK30|CHANGES EFFECTING MANUFACTURING PROCESSES INCLUDING:  1) QUALIFYING ADDITIONAL SPACE IN THE SAME FACILITY FOR THE ENZYME TREATMENT PROCESS USING THE SAME DEDICATED EQUIPMENT,  2) EQUIPPING THE ALKALI TREATMENT PROCESSING VESSELS WITH A DEDICATED TEMPERATURE PROBE AND CHART RECORDER TO CONTINUOUSLY MONITOR AND RECORD PRODUCT IN THE VESSELS DURING PROCESSING,  3) USE OF AN ADDITIONAL MANUFACTURING AREA, AND  4) USING A MICROWAVE MOISTURE ANALYZER, INSTEAD OF A DRY HEAT OVEN, FOR DRYING THE WEIGHTED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.
P840062|S008|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLAPLUG, COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2003|05/16/2003|||OK30|CHANGES AFFECTING MANUFACTURING PROCESSES INCLUDING:  1) QUALIFYING ADDITIONAL MANUFACTURING ROOM,  2) MODIFYING THE TEMPERATURE MONITORING METHOD,  3) ADDITION OF A DIFFERENT AGENT FOR CLEANSING THE MANUFACTURING AREA, AND  4) MODIFYING THE METHOD FOR DRYING THE WEIGHED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.
P010025|S003|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2003|10/10/2003|||APPR|APPROVAL FOR THE FOLLOWING USER ENHANCEMENTS AND COMPONENTS; AN ADDITIONAL PERIPHERAL CONTRAST ENHANCEMENT (PCE) BASED IMAGE PROCESSING MECHANISM;  THE ADDITION OF A HIGH RESOLUTION FUJI FM-DP L IMAGE PRINTER; AND UPDATED LABELING CHANGES FOR THE SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (FFDM).
P990080|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS TECNIS, WITH Z-SHARP OPTIC TECHNOLOGY|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/2003|03/01/2004|||APPR|APPROVAL TO REVISE THE PACKAGE INSERT WITH CLAIMS REGARDING REDUCTION IN POSTOPERATIVE SPHERICAL ABERRATIONS COMPARED TO LENSES WITH SPHERICAL OPTICS AND IMPROVED NIGHT DRIVING SIMULATOR PERFORMANCE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECNIS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFI-CATION.  THE LENSES ARE INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P890017|S011|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|CORDIS PALMAZ BALLOON EXPANDABLE STENTS|MAF|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2003|07/15/2003|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.
P960043|S045|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER M|MGB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2003|05/16/2003|||APPR|APPROVAL FOR INTRODUCING A NEW TEST METHOD TO EVALUATE THE LINK TO CUFF JOINT STRENGTH.
P010033|S005|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB KIT|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2003|05/12/2003|||OK30|CHANGE THE SUPPLIER FOR PHYTOHAEMAGGLU-TININ (PHA-P), WHICH IS USED TO FORMULATE THE MITOGEN COMPONENT IN THE QUANTIFERON-TB KIT.
P990041|S003|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/18/2003|06/11/2003|||APPR|APPROVAL FOR THE REVISED PACKAGE INSERT.
P990055|S006|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS|NAF|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/21/2003|05/09/2003|||APPR|APPROVAL FOR LABELING CHANGES TO THE ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS.
P820088|S016|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD-500 HYPERTHERMIA SYSTEM|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/2003|10/08/2003|||APPR|APPROVAL TO REPLACE THE COMPUTER AND MONITOR AND FOR THE MINOR UPGRADE FOR THERMOMETRY CALIBRATION METHOD.
P830055|S084|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/22/2003|06/10/2003|||APPR|APPROVAL FOR TWO LINE EXTENSIONS:  THE ADDITION OF PFC SIGMA RP TC3 TIBIAL INSERTS THAT ARE COMPATIBLE WITH THE MBT REVISION TIBIAL TRAY COMPONENTS, AND ADDING A SMALLER (SIZE 1.5) PFC SIGMA RP TIBIAL INSERT IN BOTH CURVED AND STABILIZED VERSIONS.
P960013|S013|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL SDX PERMANENT PACEMAKER LEADS, MODELS 1688T/TC|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/23/2003|06/13/2003|||APPR|APPROVAL FOR ADDITION OF A FLUOROSCOPIC MARKER IN THE HELIX TIP, AND IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE ATRIUM OR THE VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
P020007|S001|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, RENAL|MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|04/22/2003|05/15/2003|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P850022|S014|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR|LOF|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/23/2003|05/23/2003|||APPR|APPROVAL FOR ADDITIONAL LABELING TO EMPHASIZE THE PROPER USE OF THE DEVICE ELECTRODES.
P890047|S015|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/24/2003|05/23/2003|||APPR|APPROVAL FOR ADDITION FOR THE FOLLOWING PRECAUTION TO THE PRODUCT INSERT:  "USE ONLY IF THE CONTAINER IS UNDAMAGED."
P840064|S024|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/24/2003|05/23/2003|||APPR|APPROVAL FOR ADDITION FOR THE FOLLOWING PRECAUTION TO THE PRODUCT INSERT:  "USE ONLY IF THE CONTAINER IS UNDAMAGED."
P000046|S008|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II,  SHELLGEL AND COEASE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2003|05/22/2003|||OK30|MANUFACTURING CHANGE FOR AN ADDITIONAL PROCESS CONTROL TREATMENT FOR STAARVISC II, SHELLGEL AND COEASE.
P010022|S003|ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Sealant,polymerizing|COSEAL SURGICAL SEALANT (ORIGINAL AND PRE-MIXED)|NBE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/26/2003|05/06/2003|||APPR|APPROVAL FOR MODIFIED REAL-TIME STABILITY PROTOCOLS AND REAL-TIME COMMERCIAL LOT AGING PROTOCOLS TO INCLUDE MECHANICAL AND VISCOSITY TESTING.
P000032|S003|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|04/24/2003|08/08/2003|||APPR|APPROVAL FOR EARLY TERMINATION OF THE CLINICAL TECHNIQUE STANDARDIZATION POST-APPROVAL STUDY.
P010012|S012|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION (VERSION 3.2)|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2003|07/02/2003|||APPR|APPROVAL FOR THE MODEL 2848 CONTAK CD PROGRAMMER SOFTWARE APPLICATION, VERSION 3.2.
P010013|S005|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|04/25/2003|05/27/2003|||APPR|APPROVAL FOR REMOVAL OF THE OPTION TO OVERRIDE THE CAVITY INTEGRITY ASSESSMENT SYSTEM.
P010012|S013|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FINISHING WIRE UNIVERSAL|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/25/2003|06/09/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE FINISHING WIRE CAP SECTION OF THE COMMERCIALLY AVAILABLE FINISHING WIRE UNIVERSAL WHICH WILL ALLOW IT TO BE COMPATIBLE WITH THE IS-1 TERMINAL PIN AS WELL AS THE LV-1 TERMINAL PIN OF THE EASYTRAK LEADS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FINISHING WIRE UNIVERSAL, MODELS 6001-6007 AND IS INDICATED FOR USE WITH GUIDANT CORONARY VENDUS LEADS.
P990069|S001|DOT MEDICAL PRODUCTS LTD.|3 BAILY COURT, GREEN STREET||MACCLESFIELD, CHESHIRE||SK10||SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|ALERT SYSTEM-COMPANION II|MTE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/2003|09/29/2003|||APPR|APPROVAL FOR THE ALERT SYSTEM, COMPANION II.  THE DEVICE, AS MODIFIED, IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION.
P810025|S022|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC & AMVISC PLUS|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2003|08/19/2003|||APPR|APPROVAL FOR A CHANGE IN THE USE OF HYALURONIC ACID POWDER AS AN ALTERNATE RAW MATERIAL AND FOR THE USE OF AN ALTERNATE ENDOTOXIN TEST.
P990009|S014|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL NT HEMOSTATIC MATRIX|LMF|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/29/2003|07/10/2003|||APPR|APPROVAL FOR AN ALTERNATE TRADE NAME FOR THE APPROVED KIT CONFIGURATION THAT DOES NOT CONTAIN A THROMBIN COMPONENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL NT HEMOSTATIC MATRIX AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P900060|S025|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/2003|08/01/2003|||APPR|APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE TO FIVE YEARS FOR THE CARBOMEDICSCARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP).
P990037|S018|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT PRO SEALING DEVICE, DIAGNOSTIC DUETT PRO SEALING DEVICE  AND D-STAT FLOWABLE HEMOSTAT|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2003|05/27/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT VASCULAR SOLUTIONS, INC., MINNEAPOLIS, MINNESOTA.
P950034|S025|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2003|05/28/2003|||OK30|MANUFACTURING PROCESS CHANGE TO EXTEND THE ENDOTOXIN SPECIFICATION LIMIT OF HYALURONIC ACID (HA) RAW MATERIAL FROM <=0.04 EU/MG TO <=0.08 EU/MG.
P850020|S018|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA COLUMN|LKN|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2003|05/30/2003|||OK30|CHANGES TO THE STERILIZATION LOAD CONFIGURATION AND LENGTH OF STERILIZATION CYCLE.
P020026|S001|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2003|10/21/2003|||APPR|APPROVAL FOR AN ADDITIONAL TEST LAB FOR POST-STERILE ANALYTICAL TESTING.  THE FACILITY IS LOCATED AT CARDINAL HEALTH PHARMACEUTICAL TECHNOLOGIES AND SERVICES CENTER, SOMERSET, NEW JERSEY.
P980035|S028|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE|DXY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|05/01/2003|10/03/2003|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P790017|S080|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|STORMER Z BALLOON DILATATION/NC STORMER Z BALLOON DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2003|05/02/2003|||OK30|CHANGE TO THE ADHESION PROCESS FOR THE Z-COMPONENT IN THE MANUFACTURE OF THE DEVICES.
P960052|S006|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND TOPICAL SKIN ADHESIVE|MPN|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2003|06/13/2003|||APPR|APPROVAL FOR TWO CHANGES TO THE LABELING:  1) CHANGE THE INSTRUCTIONS FOR USE TO STATE THAT TWO LAYERS OF ADHESIVE SHOULD BE APPLIED INSTEAD OF THREE LAYERS AND  2) THE ADDITION OF LANGUAGE STATING THAT THE DEVICE CAN ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN INTACT.
P980031|S005|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS PRESCRIPTION INSERTS|LQE|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2003|05/30/2003|||OK30|IMPLEMENTING THE OUTSOURCING OF THE INSPECTION, CLEANING AND PACKAGING OPERATIONS FOR INTACS INSERTS TO THE QUALIFIED CONTRACT MANUFACTURER, BIOTEST LABORATORIES, INC.
P920047|S019|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2003|06/19/2003|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT PLEXUS EA SEATTLE, BOTHELL, WASHINGTON.
P960040|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/2003|10/22/2003|||APPR|APPROVAL TO ENABLE THE AUTOMATIC INTRINSIC RHYTHM ID ALGORITHM UPDATE FEATURE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY VR/DR/VITALITY+ DR AICD SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2857 VERSION 1.6 AND IS INDICATED FOR USE AS FOLLOWS:  THE VITALITY VR/DR/VITALITY+ DR AICE SYSTEM IS INDICATED FOR USE IN PATIENTS WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS.  IN ADDITION, THIS DEVICE IS INDICATED FOR PROPHYLACTIC TREATMENT OF PATIENTS WITH A PRIOR MYOCARDIAL INFARCTION AND EF <30%.
P910073|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/05/2003|06/24/2003|||APPR|APPROVAL FOR 70-CM LEAD LENGTHS FOR THE ENDOTAK RELIANCE STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD (MODELS 0143 AND 0153).
P860047|S014|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2003|06/06/2003|||OK30|CHANGE IN THE FREQUENCY OF THE BIOBURDEN TESTING FOR OCUCOAT.
P920014|S021|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE XVE LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2003|10/31/2003|||APPR|APPROVAL FOR THE USE OF A NEW INFLOW VALVE ASSEMBLY DESIGN FOR THE THORATEC HEARTMATE XVE LVAS.
P970058|S016|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER M1000 SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/08/2003|09/10/2003|||APPR|APPROVAL FOR A NEW SOFTWARE RELEASE (V5.0) THAT:  1) PROVIDES THE USER WITH A CHOICE OF TWO OPERATING POINTS (ONE WITH HIGHER SENSITIVITY AND INCREASED FALSE MARKS AND THE OTHER WITH LOWER FALSE MARKS WITH DECREASED SENSITIVITY, CHOSEN AT THE TIME OF DEVICE INSTALLATION) FOR USE WITH FILM/SCREEN IMAGES ONLY;  2) WHEN PACKAGED WITH V3.1A SOFTWARE IN A SINGLE IMAGE CHECKER HOUSING, ALLOWS THE PROCESSING OF BOTH ANALOG AND GE FFDM IMAGES;  3) ALLOWS CAD PROCESSING OF GE FFDM DICOM IMAGES FORMATTED FOR PRESENTATION; AND  4) REDUCES THE NUMBER OF OVERSIZED MALIGNANT CALCIFICATION  CLUSTERS MISSED BY EARLIER ALGORITHMS.
P960043|S046|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|CLOSER XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM|MGB|CV|Normal 180 Day Track||N|06/17/2003|11/25/2003|||APPR|APPROVAL FOR VARIOUS DIMENSIONAL CHANGES WHICH RESULT IN A LARGER VERSION OF THE ORIGINAL DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLOSER XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITES OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 8 FR SHEATHS.
P000018|S033|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2003|06/11/2003|||OK30|CONVERTING DEMONSTRATOR DEVICES TO COMMERCIALLY AVAILABLE DEVICES BY ADDING AN ANTIMICROBIAL FLUSH TO THE MANUFACTURING PROCESS.
P970020|S044|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX ZETA CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/13/2003|07/16/2003|||APPR|APPROVAL FOR A MODIFICATION TO THE DELIVERY SYSTEM FOR THE MULTI-LINK RX ZETA CORONARY STENT SYSTEM.
P980003|S007|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETERS|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/2003|09/02/2003|||APPR|APPROVAL FOR THE CHILLI II COOLED ABLATION CATHETER.  THE DEVICE IS INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING; DELIVERY DIAGNOSTIC PACING STIMULI; AND RADIOFREQUENCY ABLATION OF MAPPABLE VENTRICULAR TACHYCARDIAS ATTRIBUTABLE TO ISCHEMIC HEART DISEASE OR CARDIOMYOPATHY IN PATIENTS WHO HAVE FAILED DRUG THERAPY.
P010018|S002|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CK SYSTEM|MWD|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2003|06/09/2003|||OK30|ALTERNATE TEST METHOD FOR EVALUATION OF THE RADIOFREQUENCY OUTPUT OF THE RCS-300 CONSOLE DURING FINAL DEVICE TESTING.
P980031|S006|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS PRESCRIPTION INSERTS|LQE|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2003|11/05/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE IN SUNNYVALE, CALIFORNIA.
P980018|S002|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|DAKOCYTOMATION HERCEP TEST|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2003|06/11/2003|||OK30|CHANGE IN THE MANUFACTURING METHOD FOR THE CONJUGATION OF THE TWO PROTEINS TO THE ACTIVATED DEXTRAN TO ONE STEP FOLLOWED BY ONLY ONE PURIFICATION STEP.
P990037|S019|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/16/2003|06/13/2003|||APPR|APPROVAL FOR A SHELF-LIFE EXTENSION OF THE TRIS DILUENT COMPONENT, FOR THE DEVICES LISTED ABOVE, FROM THE APPROVED 24 MONTHS TO 36 MONTHS.
P010002|S004|COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES|150 GLOVER AVE.||NORWALK|CT|06856||Tissue adhesive for the topical approximation of skin|INDERMIL TISSUE ADHESIVE|MPN|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/2003|11/12/2003|||APPR|APPROVAL FOR THE ADDITION OF A CANNULA TO THE APPLICATOR AND A MICROBIAL BARRIER CLAIM TO THE LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INDERMIL. TISSUE ADHESIVE AND IS INDICATED FOR THE CLOSURE OF TOPICAL SKIN INCISIONS INCLUDING LAPAROSCOPIC SKIN INCISIONS, AND TRAUMA-INDUCED LACERATIONS IN AREAS OF LOW SKIN TENSION THAT ARE SIMPLE, THOROUGHLY-CLEANSED, AND HAVE EASILY APPROXIMATED SKIN EDGES.  IN VITRO STUDIES HAVE ALSO SHOWN THAT INDERMIL MAY ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN THE ADHESIVE FILM REMAINS UNBROKEN.  INDERMIL TISSUE ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.
P990046|S007|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2003|08/01/2003|||APPR|APPROVAL FOR A CUFF DESIGN CHANGE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATS OPEN PIVOT BILEAFLET HEART VALVE, APEX AORTIC MODELS 503DA16, 503DA18, 503DA20, 503DA22, 503DA24, 503DA26, AND 503DA28, AND APEX MITRAL MODELS 503DM24, 503DM26, AND 503DM28 AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES.
P980049|S009|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2003|07/02/2003|||APPR|APPROVAL FOR DOWN-SIZED VERSIONS OF THE ALTO MODELS DR 614 AND VR 615 IMPLANTABLE CARDIOVERTER DEFIBRILLATOS (ICDS), MODIFICATIONS TO THE ORCHESTRA APPLICATION SOFTWARE, AND THE ADDITION OF SEPARATELY PACKAGED IS-1 AND DF-1 PORT PLUGS.  THE ICD DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ALTO DR MODEL 624 ICD AND ALTO VR MODEL 625, AND ARE INDICATED FOR USE IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS:  (1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA; (2) RECURRENT, POORLY TOLERATED, SUSTAINED VENTRICULAR TACHYCARDIA (VT).  NOTE:  THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE VT PATIENTS IS NOT FULLY KNOWN.  SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.   THE MODIFIED APPLICATION SOFTWARE WILL BE MARKETED UNDER THE TRADE NAME ORCHESTRA APPLICATION SOFTWARE (ELAVIEW 1.06 UG2).
P920015|S028|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO STEROID-ELUTING LEAD MODEL 6944|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2003|07/21/2003|||APPR|APPROVAL FOR ADDITION OF THE DEXAMETHASONE SODIUM PHOSPHATE (DSP) STEROID TO THE LEAD TIP.
P010050|S003|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS.|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2003|06/11/2003|||OK30|ADDITIONS TO THE MANUFACTURING PROCESS AND PROVIDE ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH AND RELIABILITY FOR THE DEVICE.
P890064|S012|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 HPV DNA TEST|MAQ|MI|Special (Immediate Track)||N|05/20/2003|06/20/2003|||APPR|APPROVAL FOR MODIFICATION OF LOT RELEASE TESTING FOR DETECTION REAGENT 1 (DR1) COMPONENT.
P000043|S006|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/2003|06/24/2003|||APPR|APPROVAL TO EXTEND THE SHELF LIFE OF THE RX-200 TREATMENT CATHETER (A COMPONENT OF THE TMX-2000 BPH THERMOTHERAPY SYSTEM) TO THREE (3) YEARS.
P960058|S031|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2003|06/06/2003|||APPR|APPROVAL FOR CHANGES TO THE FOLLOWING PARTS OF THE BEHIND-THE-EAR (BTE) SOUND PROCESSOR:  1) THE TOGGLE SWITCH,  2) THE BTE BATTERY,  3) THE ACCESSORIES AVAILABLE WITH THE CURRENT BTE,  4) THE NEW ACCESSORY ITEMS,  5) THE AURIA HEADPIECE, AND  6) THE ESD WARNING IN THE PACKAGE INSERT.
P860047|S015|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2003|11/25/2003|||APPR|APPROVAL FOR A CHANGE IN THE FREQUENCY OF THE EO RESIDUAL TESTING FOR THE OCUCOAT.
P980035|S029|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC SIGMA PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2003|06/06/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE CONNECTOR IN THE SIGMA AND 350 SERIES PACEMAKERS TO IMPROVE YIELD AND MANUFACTURABILITY.
P000053|S001|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS SPHINCTER 800 URINARY CONTROL SYSTEM|EZY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/27/2003|06/16/2003|||APPR|APPROVAL OF THE "QUICK CONNECT" SUTURELESS WINDOW 3-WAY CONNECTOR, AN ACCESSORY TO THE AMS SPHINCTER 800 URINARY PROSTHESIS.
P960040|S033|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM AVT|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2003|06/25/2003|||APPR|APPROVAL FOR THE VENTAK PRIZM AVT AICD, MODEL 2849, PROGRAMMER SOFTWARE VERSION 2.5.
P010032|S008|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/28/2003|08/22/2003|||APPR|APPROVAL FOR THE USE OF THE MODEL A127 LEAD EXTENSION (MODELS 2341, 2342, 2343 AND 2346) WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P980046|S006|HOME ACCESS HEALTH CORP.|2401 W. HASSELL|SUITE 1510|HOFFMAN ESTATES|IL|60195|5200|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|HOME ACCESS HEPATITIS C CHECK TEST SERVICE|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2003|09/08/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FITZCO, INC., SPRING PARK, MINNESOTA.
P000018|S034|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2003|06/25/2003|||OK30|CHANGE OF ADDITIONAL PROGRAMMING AND USE OF A REWORKED PRINTED CIRCUIT BOARD ASSEMBLY.
P010034|S004|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/2003|10/31/2003|||APPR|APPROVAL FOR THREE USER PREFERRED THRESHOLD SETTINGS FOR THE PERFORMANCE OF SECOND LOOK ANALOG 6.0 CAD SYSTEM, UPDATED CAD ALGORIGHMS TO INCREASE SENSITIVITY, AND NEW UPDATED COMMERCIAL DATABASE DRIVER FOR IMPROVED SPEED AND RELIABILITY FOR THE SYSTEM.
P020004|S004|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/2003|10/15/2003|||APPR|APPROVAL FOR THE ADDITION OF LARGER SIZE CONTRALATERAL LEG COMPONENTS FOR THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE) AND FOR THE ADDITION OF THE W.L. GORE & ASSOCIATES WOODY SPRINGS FACILITY LOCATED IN FLAGSTAFF, ARIZONA, WHICH WILL BE USED TO MANUFACTURE THE LARGER SIZED CONTRALATERAL LEG COMPONENTS.
P990026|S017|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||GLUCOSE OXIDASE, GLUCOSE|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|CGA|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2003|06/17/2003|||OK30|CHANGE TO AN EQUIVALENT IN-HOUSE SUPPLIER OF THE RAW MATERIAL PLATINUM/CARBON (PT/C) COMPOSITE ELECTRODE INK FOR THE MANUFACTURE OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR.
P900043|S044|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|STENT, CORONARY|BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2003|07/02/2003|||APPR|APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT CORDIS DE MEXICO S.A. DE C.V., CHIHUAHUA, MEXICO.
P960028|S009|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY 2 MODEL SA44 MULTIFOCAL INTRAOCULAR LENS (IOL)|MFK|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/2003|08/29/2003|||APPR|APPROVAL FOR EXTENDING THE POWER RANGE OF THE ARRAY 2 MODEL SA44 MULTIFOCAL IOL UP TO 35 DIOPTERS.
P860057|S022|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2003|01/26/2004|||APPR|APPROVAL FOR THE ADDITION OF A POST-FIXATION TISSUE HEAT TREATMENT STEP IN GLUTARALDEHYDE SOLUTION PRIOR TO THE EDWARDS XENOLOGIX TISSUE VALVE PROCESSING STEPS.  THE DEVICES, AS MODIFIED, WILL BE MARKETED WITH THE REFERENCE TO THERMAFIX AS THE TRADEMARK/BRAND NAME FOR THE TISSUE PROCESSING METHOD AND WILL BE IDENTIFIED ACCORDING TO THE FOLLOWING MODIFIED MODEL NUMBERS: MODELS 2700TFX, 2800TFX, 6900PTFX, AND 3000TFX.
P960004|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2003|07/02/2003|||OK30|ADDITION OF A BIOCOMPATIBLE ADHESIVE TO THE LEAD WHICH WILL ENHANCE THE ABILITY TO MAINTAIN THE POSITION OF THE DRUG-ELUTING COLLAR AT ITS DESIGNED LOCATION.
P860019|S195|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2003|10/17/2003|||APPR|APPROVAL FOR AN ALTERNATE PROCESS TO FORM AND FOLD THE BALLOON WINGS.
P850007|S027|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2003|04/05/2005|||APPR|APPROVAL TO MODIFY THE PHYSIO-STIM LITE, MODELS 202L, 303L, 215L, 313L, 314L AND SPINAL-STIM MODELS 212L AND 212LE AS FOLLOWS: 1) CHANGE THE POWER SOURCE FROM A 9-VOLT DISPOSABLE BATTERY TO AN 11.1-VOLT RECHARGEABLE; 2) CHANGE THE USER INTERFACE FROM A THREE COLOR LED TO A BACKLIT LCD DISPLAY; 3) CHANGE THE CIRCUIT ASSEMBLY FROM SEPARATE BOARDS FOR THE DRIVE CIRCUIT AND MICROCONTROLLER TO A SINGLE BOARD; 4) ADD AN OPTIONAL PERSONAL DATA ASSISTANT (PDA) THAT MAY BE USED TO SET DAILY SHUTDOWN TIME FOR ORTHOFIX PERSONNEL USE ONLY; AND 5) CHANGE THE SERIAL PORT CABLE ON THE COMPLIANCE PRINTER TO AN INFRARED PORT.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 ANDSPINAL-STIM MODEL 2212.  THE PHYSIO-STIM MODELS ARE INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECTS IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED.  A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HEALING.  THE SPINAL-STIM IS A NONINVASIVE ELECTROMAGNETIC BONE GROWTH STIMULATOR INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS AND AS A NONOPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE LAST SURGERY.
P990074|S015|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|MCGHAN SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2003|07/22/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INAMED CORPORATION, WICKLOW, IRELAND.
P980035|S030|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|ENPULSE INPLANTABLE PULSE GENERATOR|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/2003|12/18/2003|||APPR|APPROVAL FOR ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENPULSE IPG AND IS INDICATED AS FOLLOWS: ENPULSE PACEMAKERS ARE INDICATED FOR USE IN PATIENTS WHO ARE EXPERIENCING ACCEPTED CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE:  1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK.  2) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK.3) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS.4) BRADYCARDIA-TACHYCARDIA SYNDROME.5) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES.  ENPULSE PACEMAKERS ARE ALSO INDICATED FOR USE IN PATIENTS WHO MAY BENEFIT FROM RATE RESPONSIVE PACING TO SUPPORT CARDIAC OUTPUT DURING VARYING LEVELS OF ACTIVITY.  USING RATE RESPONSE MODES MAY RESTORE HEART RATE VARIABILITY BY IMPROVING CARDIAC OUTPUT.  THESE DEVICES ARE ALSO INDICATED FOR USE IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY THROUGH THE USE OF DUAL CHAMBER MODES AND ATRIAL TRACKING MODES.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY.  DUAL CHAMBER MODES ARE INDICATED FOR USE IN PATIENTS WHO HAVE EXPERIENCED ONE OR BOTH OF THE FOLLOWING CONDITIONS:  1) VARIOUS DEGREES OF AV BLOCK  2) VVI INTOLERANCE (FOR EXAMPLE, PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.  THIS DEVICE IS ALSO INDICATED FOR VDD PACING IN PATIENTS WHO HAVE ADEQUATE RATES AND ONE OR BOTH OF THE FOLLOWING CONDITIONS:  1) A REQUIREMENT FOR VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT.  THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT OR WHEN PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED.  2) A REQUIREMENT FOR INTERMITTENT VENTRICULAR PACING DESPITE A NORMAL SINUS RHYTHM AND NORMAL...
P020045|S001|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CYROABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/05/2003|04/13/2004|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P000008|S006|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/2003|12/05/2003|||APPR|APPROVAL FOR AN ADDITIONAL SIZE (11.0 CM) FOR THE LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VANGUARD LAP-BAND.
P970004|S025|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM|EZW|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/02/2003|06/08/2004|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P000049|S009|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2003|07/03/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVES A CHANGE TO BACTERIAL ENDOTOXIN ASSAY SAMPLE SIZE.
P830055|S085|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2003|02/25/2004|||APPR|APPROVAL FOR A MANUFACTURING FACILITY FOR THE TROCHLEAR COMPONENTS OF THE PATELLOFEMORAL REPLACEMENT SYSTEM, IN VANDALIA, OHIO.
P950022|S017|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|ST.JUDE MEDICAL RIATA DEFIBRILLATION LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2003|07/01/2003|||APPR|APPROVAL FOR THE ADDITION OF A FLUOROSCOPIC MARKER IN THE HELIX TIP AND THE ADDITION OF NEW LEAD LENGTHS AND MINOR MODIFICATIONS TO THE SUTURE SLEEVE.  THE LEADS ARE INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE ATRIUM OR THE VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
P910065|S004|TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ST AIA-PACK PA|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2003|08/12/2003|||APPR|APPROVAL FOR DESIGN CHANGES TO INCLUDE REDUCTION OF THE INCUBATION TIME FROM 40 TO 10 MINUTES, CHANGE IN THE CONJUGATE DILUENT, DECREASE IN ALP ACTIVITY AND CHANGE IN PACKAGING SIZE FROM  200 TESTS TO 100 TESTS PER BOX.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST AIA-PACK PA AND IS INDICATED FOR:  ST AIA-PACK PA IS DESIGNED FOR IN VITRO DIAGNOSTIC USE ONLY FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM ON TOSOH AIA NEX*IA AND TOSOH AIA-600 II ANALYZERS.  THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER (CAP) IN MEN FIFTY YEARS OF AGE AND OLDER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER.  THE DEVICE IS FURTHER INDICATED FOR THE SERIAL MEASUREMENT OF PSA IN HUMAN SERUM TO BE USED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATIC CANCER.
P000013|S002|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEONICS ABC/TRIDENT SYSTEMS|MRA|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/2003|09/12/2003|||APPR|APPROVAL FOR REVISIONS TO THE TRIDENT ACETABULAR SYSTEM PACKAGE INSERT AND PATIENT LABELING.  THESE CHANGES INCLUDE EDITING TEXT FOR CONCISENESS AND CLARITY, REORGANIZING ELEMENTS TO MORE CLEARLY CONVEY INTENT, AND PRESENTING DATA IN A MANNER THAT IS LESS CONFUSING AND MORE MEANINGFUL TO PATIENTS AND SURGEONS.
P900056|S077|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2003|07/08/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WHICH INVOLVES THE ELIMINATION OF THE QA AUDIT FOR THE CATHETER BURR SUBASSEMBLY.
P800002|S013|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2003|07/11/2003|||OK30|CHANGE THE PROCEDURE FOR RECORDING TEMPERATURES DURING THE DRY HEAT STERILIZATION PROCESS OF THE AVITENE PRODUCTS.
N17600|S020|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)  FLOUR AND AVITENE ULTRAFOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2003|07/11/2003|||OK30|CHANGE THE PROCEDURE FOR RECORDING TEMPERATURES DURING THE DRY HEAT STERILIZATION PROCESS OF THE AVITENE PRODUCTS.
P790027|S069|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|PMMA POSTERIOR CHAMBER IOL|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P840039|S051|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P850059|S024|BAUSCH & LOMB SURGICAL, INC.|1400 N. GOODMAN ST.||ROCHESTER|NY|14609||intraocular lens|POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P860002|S018|BAUSCH & LOMB|1400 North Goodman Street||Rochester|NY|14609||intraocular lens|POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P870013|S016|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P870073|S017|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P880090|S018|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P910056|S008|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|SILICONE INTRAOCULAR LENSES|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P910058|S012|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|intraocular lens|SILICONE INTRAOCULAR LENSES|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P910061|S009|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SILICONE INTRAOCULAR LENSES|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P990014|S003|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|HYDROVIEW IOLS|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
P990009|S015|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX HEMOSTATIC SEALANT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2003|07/03/2003|||OK30|CHANGE FROM A MANUAL PACKAGING PROCESS TO A SEMI-AUTOMATED PROCESS.
P920014|S022|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE XVE AND VE LEST VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/2003|12/02/2003|||APPR|APPROVAL FOR A MODIFIED STROKE VOLUME LIMITER DESIGN FOR THE HEARTMATE XVE AND SNAP-VE DEVICES.
P000025|S010|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/16/2003|07/25/2003|||APPR|APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE THE FOLLOWING ACCESSORIES FOR THE TEMPO+ SPEECH PROCESSOR: TELEMIC AND MICROPHONE TEST DEVICE (MTD).  THE TELEMIC IS INDICATED FOR THE COMBI 40+ COCHLEAR IMPLANT USER WHO DESIRES EITHER A DIRECT CONNECTION TO A TELEPHONE OR AN INDUCTION LOOP OR ADDITIONAL AMPLIFICATION OF THE TEMPO+ SPEECH PROCESSOR INTERNAL MICROPHONE.  THE MTD IS INDICATED FOR INDIVIDUALS WHO WISH TO QUALITATIVELY MONITOR THE MICROPHONE SIGNAL OF THE TEMPO+ SPEECH PROCESSOR.
P000014|S006|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2003|07/09/2003|||OK30|INTRODUCTION OF AN ADDITIONAL RAW MATERIALS SUPPLIER FOR UNCOATED MICROWELLS THAT ARE USED FOR THE MANUFACTURE OF THE COATED MICROWELLS BY ORTHO-CLINICAL DIAGNOSTIC FOR THE ANTI-HBS REAGENT PACK.
P990037|S020|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2003|07/11/2003|||OK30|CHANGE IN THE TENSILE TEST METHOD, WHICH TESTS THE FUNCTIONALITY OF THE CATHETER USING A METHOD THAT ALIGNS IT WITH THE REQUIRED SPECIFICATION.
P990034|S004|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC ISOMED MODEL 8472 FIXED RATE INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/2003|07/21/2003|||APPR|APPROVAL FOR LABELING CHANGES TO THE MODELS 8553 AND 8555 ISOMED REFILL KIT INSTRUCTIONS FOR USE AND THE TECHNICAL MANUAL.
P020014|S004|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/21/2003|07/17/2003|||APPR|APPROVAL FOR NEW EXPIRATION DATES FOR THE GAMMA CATHETER (WITH PACKAGING PROCESS IMPROVEMENTS) AND THE COIL CATHETER (WITH PACKAGING PROCESS IMPROVEMEMENTS.)
P960043|S047|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR XL 8 AND 10 FRENCH, CLOSER, CLOSER S, PERCLOSE AT, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/2003|09/02/2003|||APPR|APPROVAL TO ADD WORDING IN THE PRECAUTIONS SECTION IN THE LABELING, INFORMING THE USER THAT REACCESS/REPUNCTURE OF THE FEMORAL ARTERY WITH THE ABOVE LISTED DEVICES IS NOT RESTRICTED FOR PATIENTS WHO HAVE PREVIOUSLY RECEIVED THESE DEVICES IN EARLIER ARTERIOTOMY REPAIRS.
P000025|S011|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2003|07/22/2003|||APPR|APPROVAL FOR VERTICAL INTEGRATION OF THE COCHLEAR IMPLANT LASER WELDING PROCESS AT THE MANUFACTURING SITE LOCATED AT MED-EL MEDICAL ELECTRONICS, INNSBRUCK, AUSTRIA.
P970003|S047|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2003|08/14/2003|||APPR|APPROVAL FOR THE NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM MODEL 102R GENERATOR, HUMAN FACTORS IMPROVEMENTS TO THE MODEL 102 GENERATOR AND LABELING CHANGES TO THE MODEL 302 LEAD WHICH ARE INDICATED FOR USE AS AN ADJUNCTIVE THERAPY IN REDUCING THE FREQUENCY OF SEIZURES THAT ARE REFRACTORY TO ANTIEPILEPTIC MEDICATIONS.
P010038|S004|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|ICAD SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/2003|10/10/2003|||APPR|APPROVAL FOR A CHANGE IN THE MAMMOGRAPHY FILM DIGITIZER FROM THE FORMERLY APPROVED MULTIRAD 860 TO THE FULCRUM.
P970021|S009|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|CATHETER, BALLOON, TRANSCERVICAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MKN|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2003|12/22/2003|||APPR|APPROVAL FOR THE REMOVAL OF THE PRESSURE RELIEF VALVE (PRV).
P980003|S008|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/20/2003|08/07/2003|||APPR|APPROVAL FOR A CHANGE IN THE POST-APPROVAL STUDY PROTOCOL TO ALLOW FOR THE MAXIMUM LIMIT OF 40 PATIENTS OR 20 PERCENT OF THE TOTAL STUDY ENROLLMENT AT ANY ONE SITE.
P010012|S014|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179)|NIK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/20/2003|10/21/2003|||APPR|APPROVAL FOR AN EXPANDED INDICATION FOR YOUR MARKETED CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES.   THE DEVICES ARE INDICATED FOR:  PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >=120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY.  PATIENT POPULATIONS AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS INCLUDE, BUT ARE NOT LIMITED TO THOSE WITH:  1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA.  2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).  NOTE:  THE CLINICAL OUTCOME OF HEMODYNAMICALLY STABLE SUSTAINED VT PATIENTS IS NOT FULLY KNOWN.  SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.  3) PRIOR MYOCARDIAL INFARCTION, LEFT VENTRICULAR EJECTION FRACTION OF <=35%, AND A DOCUMENTED EPISODE OF NONSUSTAINED VT, WITH AN INDUCIBLE VENTRICULAR TACHYARRHYTHMIA.  PATIENTS SUPPRESSIBLE WITH IV PROCAINAMIDE OR AN EQUIVALENT ANTIARRHYTHMIC DRUG HAVE NOT BEEN STUDIED.  4) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <=30%.
P840039|S052|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|BIOBURDEN TESTING|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2003|07/23/2003|||OK30|CHANGE IN THE FREQUENCY OF THE BIOBURDEN TESTING.
P880090|S019|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|PMMA IOL'S: MODELS EZE-50, 55, 60, 65, 70, P359UV, P366UV, IO359, IO379, S122UV AND L122UV|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2003|07/23/2003|||OK30|CHANGE IN THE FREQUENCY OF THE BIOBURDEN TESTING.
P910061|S010|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|BIOBURDEN TESTING|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2003|07/23/2003|||OK30|CHANGE IN THE FREQUENCY OF THE BIOBURDEN TESTING.
P950037|S033|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|PHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/2003|12/17/2003|||APPR|APPROVAL FOR MODIFICATIONS TO HOME MONITORING THAT WILL ALLOW PHYSICIANS TO RECEIVE THE IMPLANT DATA VIA THE INTERNET, EMAIL, FAX OR MOBILE PHONE.  HOME MONITORING MAY BE USED WITH THE FOLLOWING BIOTRONIK DEVICES: PHILOS DR-T, BELOS DR-T, BELOS VR-T, AND CARDIAC AIRBAG-T.
P020026|S003|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER|NIQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2003|10/10/2003|||APPR|APPROVAL FOR THE ADDITION OF A SECOND IDENTITY METHOD FOR RAPAMYCIN IN CYPHER SIROLIMUS-ELUTING CORONARY STENTS.  THIS METHOD WILL BE PERFORMED IN CONJUNCTION WITH THE CURRENTLY APPROVED IDENTITY METHOD.  THE ADDITION OF THE SECOND IDENTITY METHOD IS IN ACCORDANCE WITH ONE OF THE CONDITIONS OF APPROVAL COMMITMENTS MADE FOR THIS PMA.
P020026|S004|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2003|04/13/2007|||APPR|APPROVAL FOR A NEW ELUTION TEST METHOD AND REVISED ELUTION SPECIFICATIONS.
P900060|S026|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE {CPHV}|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2003|07/25/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE PAPER USED IN THE MANUFACTURE OF THE VENT COVERS INCLUDED IN THE PACKAGING OF THE CARBOMEDICS PROSTHETIC HEART  VALVE  (CPHV).
P960016|S011|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2003|08/04/2004|||APPR|APPROVAL FOR MODIFYING THE MANUFACTURING CLEANING SOLVENT.
P010049|S008|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/2003|08/13/2003|||APPR|APPROVAL TO MODIFY THE DEVICE TO REDUCE THE NUMBER OF PREPARATION STEPS, SIMPLIFY THE METHOD OF STAGING THE HEMOSTATIC SPONGE INTO DELIVERY CANNULA AND PROVIDE AN EASIER INTERFACE FOR FLUSHING THE DEPTH MARKER.
P000052|S019|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS|MOU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/2003|07/24/2003|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE LABELING:  1) ADDING A WARNING STATEMENT ALERTING USERS TO THE POTENTIAL FOR A RADIATION OVERDOSE IF AN INTERRUPTED TREATMENT IS NOT RESUMED APPROPRIATELY.  2) MODIFYING THE EMERGENCY RESPONSE PROCEDURES TO ASSIST USERS TO RETRACT THE ACTIVE WIRE IN THE MOST EXPEDITIOUS MANNER WHILE MAINTAINING SAFETY OF THE PATIENT AND THE RADIATION PERSONNEL INVOLVED IN CASE OF AN EMERGENCY.
P020009|S009|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2003|07/25/2003|||OK30|CHANGE TO THE MANUFACTURING COATING PROCESS FOR ALL CURRENTLY MARKETED PTCA CATHETERS AND CORONARY STENT (BALLOON EXPANDABLE) DELIVERY SYSTEMS.
P860019|S196|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2003|07/25/2003|||OK30|CHANGE TO THE MANUFACTURING COATING PROCESS FOR ALL CURRENTLY MARKETED PTCA CATHETERS AND CORONARY STENT (BALLOON EXPANDABLE) DELIVERY SYSTEMS.
P980001|S043|Boston Scientific Corp.|One Boston Scientific Place||Natick|MA|01760||STENT, CORONARY|NIR PREMOUNTED STENT DELIVERY SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2003|07/25/2003|||OK30|CHANGE TO THE MANUFACTURING COATING PROCESS FOR ALL CURRENTLY MARKETED PTCA CATHETERS AND CORONARY STENT (BALLOON EXPANDABLE) DELIVERY SYSTEMS.
P000011|S009|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2003|12/08/2003|||APPR|APPROVAL FOR THE ADDITION OF AN 8 MM STENT IN DIAMETERS OF 3.0, 3.5, AND 4.0 MM FOR THE BIODIVYSIO OC OTW SYSTEM.
P980016|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2003|07/30/2003|||APPR|APPROVAL FOR THE USE OF THE MODEL 2490E CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE WITH THE MARQUIS VR ICD.
P990026|S018|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY|GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR|NCT|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2003|11/20/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE SIGNAL PROCESSING ROUTINE AND DATA POINT SCREENING PARAMETERS OF THE BIOGRAPHER TO REDUCE THE NUMBER OF SKIPPED READINGS, MODIFICATIONS TO THE DOWN ALERT OF THE BIOGRAPHER TO INCREASE THE SPECIFICITY OF THE ALARM FEATURE AND AN AUTOSENSOR FORMULATION CHANGE TO IMPROVE THE BIOGRAPHER CALIBRATION.
P000057|S002|INTEGRA LIFESCIENCES CORPORATION|8900 CAMERON ROAD||AUSTIN|TX|78754||Finger semi-constrained pyrolytic carbon uncemented prosthesis|ASCENSION MCP|NEG|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/2003|08/11/2003|||APPR|APPROVAL TO EXTEND THE SHELF LIFE EXPIRATION DATE FROM 2 YEARS TO 4 YEARS.
P970043|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/2003|07/16/2003|||APPR|APPROVAL FOR AN EXPANSION OF +- 0.75 D FOR THE ALLOWABLE TARGET OFFSET PARAMETER RANGE FOR THE WAVEFRONT-GUIDED MYOPIC LASIK INDICATION.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADARVISION 4000 EXCIMER LASER SYSTEM AND IS INDICATED FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE.
P020026|S005|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER|NIQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2003|11/17/2004|||APPR|APPROVAL FOR AN ADDITIONAL 500X VISUAL INSPECTION PRIOR TO CRIMPING.
P000058|S004|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2003|12/01/2003|||APPR|APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS FOR USE WITH THE INFUSE BONE GRAFT COMPONENT.  THE FOLLOWING PART NUMBERS WERE NOT INCLUDED AS PART OF THIS REQUEST: 890226, 890229, 890243, 890246, 890249, 9012426 AND 9012429;  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES:  INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE; INFUSE BONE GRAFT/INTER FIX THREADED FUSION DEVICE; AND INFUSE BONE GRAFT/INTER FIX RP THREADED FUSION DEVICE.  FOR PURPOSES OF CLARITY, THE LT-CAGE LUMBAR TAPERED FUSION DEVICE, INTER FIX THREADED FUSION DEVCIE, AND INTER FIX RP THREADED FUSION DEVICE COMPONENTS ARE COLLECTIVELY REFERRED TO AS "INTERBODY FUSION DEVICE" FOR THE REMAINDER OF THIS APPROVAL ORDER.  THE DEVICE IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, FUNCTION DEFICIT AND/OR NEUROLOGICAL DEFICIT AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. THE INFUSE BONE GRAFT/LT-CAGE DEVICES ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN OR A LAPAROSCOPIC APPROACH.   THE INFUSE BONE GRAFT/INTER FIX THREADED FUSION DEVICE; AND INFUSE BONE GRAFT/INTER FIX RP THREADED FUSION DEVICE ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN APPROACH ONLY.  PATIENTS RECEIVING THE INFUSE BONE GRAFT/INTERBODY FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/INTERBODY FUSION DEVICE.
P930039|S016|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MODEL 5076 CAPSURE FIX NOVUS ELECTRODE|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2003|08/25/2003|||APPR|APPROVAL FOR TITANIUM NITRIDE COATING OF THE ELECTRODE HELIX TIP.
P000009|S009|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM)|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/03/2003|11/13/2003|||APPR|APPROVAL FOR THE LEXOS FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND SOFTWARE MODIFICATIONS TO THE BELOS FAMILY OF ICDS, THE CARDIAC AIRBAG-T AND THE MICROPHYLAX ICD.  THE NEW DEVICE WILL BE MARKETED UNDER THE TRADE NAME LEXOS VR, LEXOS VR-T, LEXOS DR, LEXOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND PROGRAMMER SOFTWARE (A-K00.1.U/4).
P870072|S026|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER|DSQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/03/2003|11/26/2003|||APPR|APPROVAL TO EXPAND THE INDICATIONS FOR USE TO INCLUDE TRANSPORT OF PATIENTS IN FIXED WING AIRCRAFT AND IN HELICOPTERS.  THIS DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM AND TLC-II PORTABLE VAD DRIVER.  THE PVAD IS INDICATED FOR USE IN BRIDGE TO TRANSPLANT PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA: CANDIDATE FOR CARDIAC TRANSPLANTATION, IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, DEPENDENCE ON, OR INCOMPLETE RESPONSE TO, CONTINUED VASOPRESSOR SUPPORT.  IT IS ALSO INDICATED FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS.  WHEN USED WITH THE TLC-II PORTABLE PNEUMATIC DRIVER, THE PVAD IS INTENDED FOR USE FOR TRANSPORTATION OF VAD PATIENTS VIA GROUND AMBULANCE, FIXED WING AIRCRAFT OR HELICOPTER.  IN ADDITION, THE TLC-II PORTABLE PNEUMATIC DRIVER CAN BE USED TO ALLOW SUITABLY-QUALIFIED PATIENTS TO TAKE OFF-SITE EXCURSIONS WITHIN A TWO-HOUR TRAVEL RADIUS OF THE HOSPITAL IN THE COMPANY OF A TRAINED CAREGIVER.
P830055|S086|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/07/2003|11/18/2003|||APPR|APPROVAL FOR A LINE EXTENSION TO THE LCS COMPLETE FEMORAL COMPONENTS.  THAT IS, THE ADDITION OF LCS COMPLETE MODULAR FEMORAL COMPONENTS (SIZES SMALL - LARGE+).  THE LCS COMPLETE MODULAR FEMORAL COMPONENTS COMBINE FEATURES OF THE PREVIOUSLY APPROVED LCS COMPLETE PRIMARY AND REVISION FEMORAL COMPONENTS.
P990026|S019|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY|GLUCOWATCH G2 BIOGRAPHER|NCT|CH|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|07/07/2003|08/28/2003|||APPR|APPROVAL OF A POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.
P970058|S017|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2003|11/25/2003|||APPR|APPROVAL FOR THE ADDITION OF A NEW DIGITIZER, THE VIDAR DIAGNOSTIC PRO FILM DIGITIZER AND NEW CAD SOFTWARE, VERSION 6.0.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMAGECHECKER LX AND IMAGECHECKER DX DEPENDING UPON OPTIONS CHOSEN.  THE INDICATIONS ARE:  THE IMAGECHECKER LX/DX IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND VIEW.
P920023|S016|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESIS|MES|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/11/2003|08/08/2003|||APPR|APPROVAL FOR ADDITIONAL DETAILED INSTRUCTIONS FOR PROSTHESIS REMOVAL AFTER UROTHELIAL COVERAGE.
P950037|S034|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/2003|03/08/2004|||APPR|APPROVAL FOR ADDITION OF A DRUG COLLAR TO THE PACING LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX SR AND IS INDICATED AS FOLLOWING:  BOTRONIK'S SELOX SR TRANSVENOUS, STEROID-ELUTING, ACTIVE FIXATION ENDOCARDIAL LEADS ARE INDICATED FOR PERMANENT PACING AND SENSING.  ACTIVE FIXATION PACING LEADS WITH A BIPOLAR (BP) IS-1 CONNECTOR CONFIGURATION ARE DESIGNED FOR USE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS.  THE LEADS MAY BE USED WITH SINGLE OR DUAL CHAMBER PACING SYSTEMS.  THE SELOX SR LEAD MODELS ARE INTENDED FOR PLACEMENT IN EITHER THE RIGHT ATRIUM OR RIGHT VENTRICLE.
P000043|S007|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/2003|04/28/2004|||APPR|APPROVAL FOR A DESIGN CHANGE FOR THE RX-200 APPLICATOR FROM A 2.5 CM COIL TO A 2.0 CM COIL.
P990020|S014|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2003|08/08/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM WHICH INVOLVES A CHANGE IN THE METHOD OF THE JOINING PROCESS FROM ADHESIVE TO LASER-WELD FOR BOTH THE 16 FR AND 12 FR DELIVERY SYSTEMS.
P960016|S012|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/15/2003|11/21/2003|||APPR|APPROVAL FOR THE NEW LIVEWIRE TC CATHETER EXTENSION CABLE-STOCKERT, A NEW CABLE WITH THERMOCOUPLE SENSING ONLY FOR USE WITH THE STOCKERT 70 RADIOFREQUENCY CARDIAC ABLATION GENERATOR.
P020052|S001|St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|CARDIOVERSION SWITCHBOX II SYSTEM|MTE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/15/2003|08/22/2003|||APPR|APPROVAL FOR THE CARDIOVERSION SWITCHBOX II SYSTEM.  THE DEVICE IS INDICATED AS FOLLOWS:  THE CARDIOVERSION SWITCHBOX II SYSTEM CONNECTS A ST. JUDE MEDICAL CARDIOVERSION (CV) CATHETER AND EXTENSION CABLE TO A COMPATIBLE CARDIOVERTER/DEFIBRILLATOR AND EP RECORDING SYSTEM.
P990055|S007|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|BAYER ADVIA IMS CPSA ASSAY|NAF|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/2003|09/02/2003|||APPR|APPROVAL FOR THE ADDITION OF THE CPSA ASSAY TO THE BAYER ADVIA IMS SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAYER ADVIA IMS CPSA ASSAY AND IS INDICATED AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER IN CONJUNCTION WITH DIGITAL RECTAL EXAM.
P950021|S006|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|BAYER ADVIA IMS PSA ASSAY|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/2003|09/02/2003|||APPR|APPROVAL OF THE IMMUNO 1 PROSTATE SPECIFIC ANTIGEN (PSA) ON THE ADVIA INTEGRATED MODULAR SYSTEM (IMS).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA IMS PROSTATE SPECIFIC ANTIGEN (PSA) AND IS INDICATED FOR:  THE ADVIA IMS PROSTATE SPECIFIC ANTIGEN (PSA) METHOD IS FOR IN VITRO DIAGNOSTIC USE TO QUANTITATIVELY MEASURE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM.  THIS ASSAY IS INDICATED FOR THE MEASUREMENT OF THE SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEAR AND OLDER.  THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.  THIS DIAGNOSTIC METHOD IS NOT INTENDED FOR USE ON ANY OTHER SYSTEM.
P990075|S012|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2003|08/15/2003|||OK30|CHANGE IN THE SUPPLIER FOR THE SILICONE ELASTOMER FILL TUBE.
P010018|S003|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CK SYSTEM|MWD|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2003|11/06/2003|||APPR|APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS.
P990038|S005|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-MAK-2 PLUS ASSAY|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/2003|08/20/2003|||APPR|APPROVAL FOR A REVISION IN THE ASSAY PACKAGE INSERT THAT INCORPORATES A CHANGE IN THE INTERPRETATION ALGORITHM FOR REPEAT TESTING RESULTS THAT MAKE IT THE SAME AS THE INTERPRETATION FOR INITIAL TESTING.  "THE USER SHOULD APPLY THE SAME INTERPRETATION OF RESULTS (I.E. REACTIVE SAMPLES SHOULD HAVE AN ABSORBANCE VALUE GREATER THAN 90% OF THE CUTOFF) WHEN INITIAL TESTING FOR SOME SAMPLES AND REPEAT TESTING FOR OTHER SAMPLES ARE PERFORMED ON THE SAME PLATE."
P980023|S015|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-168|LWS|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|07/16/2003|10/31/2003|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P910077|S040|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/2003|12/17/2003|||APPR|APPROVAL FOR LABELING CHANGES SPECIFIC TO DEFIBRILLATOR IMPLANT TESTING CRITERIA.
P960040|S034|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/2003|12/17/2003|||APPR|APPROVAL FOR LABELING CHANGES SPECIFIC TO DEFIBRILLATOR IMPLANT TESTING CRITERIA.
P010012|S015|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|NIK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/2003|12/17/2003|||APPR|APPROVAL FOR LABELING CHANGES SPECIFIC TO DEFIBRILLATOR IMPLANT TESTING CRITERIA.
P010018|S004|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CK SYSTEM|MWD|OP|Normal 180 Day Track No User Fee|Express GMP Supplement|N|07/16/2003|07/31/2003|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE.  THE MANUFACTURING FACILITY IS LOCATED AT REFRACTEC, INC., IRVINE, CALIFORNIA.
P010030|S004|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFE VEST, MODEL  WCD 3000|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/2003|09/02/2003|||APPR|APPROVAL FOR MINOR SOFTWARE, HARDWARE, AND LABELING CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST (WCD 3000) WEARABLE DEFIBRILLATOR AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P000015|S005|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2003|08/22/2003|||APPR|APPROVAL FOR THE ADDITION OF A POLYTEREPHTHALATE (PET) MESH DISK.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT WITH PET MESH DISK AND IS INTENDED TO RESTORE USEFUL HEARING IN INDIVIDUALS WITH NEUROFIBROMATOSIS TYPE 2 (NF2) WHO ARE 12 YEARS OF AGE OR OLDER, VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS.
P000041|S002|RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|RAPIDSCREEN RS-2000D|MYN|RA|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2003|08/08/2003|||APPR|APPROVAL FOR A SECOND DEVICE NAME OF "RAPIDSCREEN DIGITAL" (ABBREVIATED "RS-DIGITAL").
P890055|S016|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/2003|08/12/2003|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:  1) REPLACE THE CURRENTLY APPROVED CATHETER KIT (AP-07002) WITH THE IP-36633 AND IP-3757 KITS,  2) REPLACE IP-36633 AND IP-3757 CONNECTOR WITH CODMAN 3000 (AP-07002) CONNECTOR, AND INCLUDE TITANIUM AS AN ALTERNATIVE CONNECTOR MATERIAL,  3) ADD ADDITIONAL COMPONENTS TO THE KIT AS A CONVENIENCE TO THE PHYSICIANS AND  4) LABELING CHANGE TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT INSTRUCTIONS FOR USE TO REFLECT THE CORRECT CATHETER VOLUME.
P840001|S069|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|INTREL 3, SYNERGY  AND SYNERGY VERSITREL NEUROSTIMULATORS|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/2003|01/06/2004|||APPR|APPROVAL FOR A REVISED LABELING ARCHITECTURE.
P000039|S006|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND PFO OCCLUDER AMPLATZER 45 DEGREE DELIVERY AND EXANGE SYSTEMS|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2003|08/21/2003|||OK30|ALTERNATE SUPPLIER FOR THE DELIVERY SHEATH, DILATOR, AND LOADING DEVICE COMPONENTS OF THE AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS AND SOME MINOR MANUFACTURING CHANGES TO ALLOW FOR COLOR CODING OF COMPONENTS.
P010017|S004|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Full field digital,system,x-ray,mammographic|SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2003|05/12/2004|||APPR|APPROVAL FOR CHANGES IN THE X-RAY FILTER, SKIN LINE ALGORITHM, OPERATOR'S MANUAL AND QC MANUAL CHANGES UNDER MQSA.
P000037|S003|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2003|12/16/2003|||APPR|APPROVAL FOR A CHANGE TO THE VENT HOLE CONFIGURATION OF THE PACKAGE AND RELATED CHANGE TO THE VENT COVER SEALER PATTERN.
P930014|S011|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) WITH THE ACRYSERT DELIVERY SYSTEM|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/25/2003|08/29/2003|||APPR|APPROVAL FOR THE ACRYSOF SINGLE-PIECE POSTERIOR CHANGER INTRAOCULAR LENS (IOL) WITH THE ACRYSERT DELIVERY SYSTEM (MODEL SA60AS), AND FOR A SHELF LIFE EXTENSION PROTOCOL.
N12159|S018|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL/SURGICEL NU-KNIT/SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT|LMG|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/25/2003|08/20/2003|||APPR|APPROVAL FOR LABELING CHANGE TO INCLUDE FOUR ANTIBIOTIC RESISTANT BACTERIAL STRAINS TO THE EXISTING LIST OF  BACTERIAL STRAINS.
P950019|S015|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY THREADED FUSION CAGE (TFC)|MAX|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2003|09/04/2003|||APPR|APPROVAL FOR LABELING CHANGES AND CHANGES IN PART NUMBERS.
P970031|S013|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2003|12/08/2003|||APPR|APPROVAL FOR THE FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM.  THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED (OCTOBER 31, 2001, UNDER SUPPLEMENT S010) PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P950037|S035|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|IMPLANT CONTROL SYSTEM (ICS) 3000|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2003|05/18/2005|||APPR|APPROVAL FOR THE IMPLANT CONTROL SYSTEM (ICS) 3000 PACEMAKER PROGRAMMING SYSTEM, USING SOFTWARE VERSION 402.U.
P010038|S005|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|ICAD SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/2003|10/31/2003|||APPR|APPROVAL FOR  1) AN UPGRADED ALGORITHM FOR THE ICAD SYSTEM,  2) USE OF THE ICAD SYSTEM DIRECTLY WITH IMAGES OBTAINED ON THE FISCHER SENOSCAN FFDM SYSTEM, AND  3) THE NEW INCLUSION OF WOMEN WITH BREAST IMPLANTS IN THE TARGET POPULATION IN THE INDICATIONS FOR USE (IFU).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ICAD SYSTEM WITH THE FOLLOWING INDICATIONS FOR USE:  THE ICAD IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDING VIEWS FROM CASES FOR PATIENTS WITH BREAST IMPLANTS AND IMAGES FROM QUALIFIED FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS, TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P990075|S013|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2003|08/14/2003|||OK30|CHANGE IN THE QUALITY CONTROL TEST SPECIFICATION TO REPLACE THE TENSILE STRENGTH SPECIFICATION WITH A BREAK FORCE SPECIFICATION FOR THE SILICONE ELASTOMER FILL TUBE COMPONENT OF THE MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES.
P990026|S020|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY|GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER|NCT|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2003|08/20/2003|||OK30|CHANGE TO THE MANUFACTURING PROCESS OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR TO ADD A SECONDARY VISUAL INSPECTION OF THE AUTOSENSORS REJECTED BY THE AUTOMATED, CAMERA-BASED INSPECTION TO INCREASE PRODUCT YIELD AND REDUCE PRODUCTION COSTS.
P960025|S011|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM|SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE|MCV|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/2003|03/05/2004|||APPR|APPROVAL FOR THE SABER LUMBER I/F CAGE.  IN ADDITION, THIS SUPPLEMENT REQUESTED THE APPROVAL OF TWO NEW SIZES, WHICH WILL NOW BE MARKETED AS THE JAGUAR LUMBAR I/F CAGE.  THESE DEVICES ARE INDICATED FOR AN OPEN POSTERIOR APPROACH USING AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE OR TWO SPINAL LEVELS FROM L2-S1 WHOSE CONDITION REQUIRES THE USE OF INTERBODY FUSION COMBINED WITH POSTEROLATERAL FUSION (360 DEGREES FUSION) AND POSTERIOR PEDICLE SCREW FIXATION .  THESE PATIENTS MAY HAVE HAD PREVIOUS NON-FUSION SPINAL SURGERY AT THE INVOLVED SPINAL LEVELS(S).  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.
P950034|S026|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFLIM ADHESION BARRIER|MCN|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/2003|09/29/2003|||APPR|APPROVAL FOR THE SEPRAFILM LABELING.
P880086|S095|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2003|08/15/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE FIRMWARE OF THE ADX FAMILY OF PULSE GENERATORS AND FOR PROGRAMMING SOFTWARE MODEL 3307 V4.4.2A TO IMPLEMENT THE MODIFIED FIRMWARE IN IMPLANTED DEVICES.
P930014|S012|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/2003|09/02/2003|||APPR|APPROVAL TO MODIFY THE PACKAGE INSERT TO CREATE A NEW WARNING BY MOVING AND STRENGTHENING EXISTING TEXT WITHIN THE APPROVED INSERT TO READ AS FOLLOWS: "THE CLINICAL STUDY OF THE ACRYSOF NATURAL SINGLE-PIECE LENS (REFERENCED IN TABLES 2 THROUGH 5) WAS CONDUCTED WITH THE LENS INTENDED FOR IMPLANTATION IN THE CAPSULAR BAG ONLY.  THERE IS NO CLINICAL DATA TO DEMONSTRATE ITS SAFETY AND EFFECTIVENESS FOR PLACEMENT IN THE CILIARY SULCUS."
P990020|S015|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2003|01/30/2004|||APPR|APPROVAL FOR USE OF A HIGH-DENSITY GRAFT MATERIAL (HDM) IN THE MANUFACTURE OF THE ANEURX STENT GRAFT.
P910023|S068|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|ADX PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2003|08/15/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE FIRMWARE OF THE ADX FAMILY OF PULSE GENERATORS AND FOR PROGRAMMING SOFTWARE MODEL 3307 V4.4.2A TO IMPLEMENT THE MODIFIED FIRMWARE IN IMPLANTED DEVICES.
P990020|S016|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT WITH XPEDIRNT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2003|08/29/2003|||OK30|ELIMINATION OF THE DESTRUCTIVE FUNCTIONAL TESTING OF STERILE FINISHED DEVICES.
P020037|S001|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|FX MINIRAIL RX PTCA CATHETER|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2003|08/28/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT CORPORATION VASCULAR INTERVENTION GROUP, TEMECULA, CALIFORNIA.
P830045|S087|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|ADX PULSE GENERATOR|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2003|08/15/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE FIRMWARE OF THE ADX FAMILY OF PULSE GENERATORS AND FOR PROGRAMMING SOFTWARE MODEL 3307 V4.4.2A TO IMPLEMENT THE MODIFIED FIRMWARE IN IMPLANTED DEVICES.
P880081|S029|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/06/2003|08/25/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE TO INCLUDE AN ADDITIONAL PRECAUTION/WARNING STATEMENT REGARDING STORAGE CONDITIONS: "AVOID EXPOSURE TO VOLATILE CHEMICALS."
P960028|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS|MFK|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/06/2003|08/25/2003|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE TO INCLUDE AN ADDITIONAL PRECAUTION/WARNING STATEMENT REGARDING STORAGE CONDITIONS: "AVOID EXPOSURE TO VOLATILE CHEMICALS."
P860019|S197|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK MONORAIL/QUANTUM MAVERICK MONORAIL PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2003|09/03/2003|||OK30|CHANGE IN THE STERILIZATION PARAMETERS.
P020009|S010|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2003|09/03/2003|||OK30|CHANGE IN THE STERILIZATION PARAMETERS.
P000052|S020|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/2003|09/03/2003|||APPR|APPROVAL FOR LABELING CHANGES AS A SHORT TERM CORRECTIVE ACTION TO A COMPLAINT INVESTIGATION.
P000011|S010|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590|9018|STENT, CORONARY|PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO SV AND OC OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/14/2003|11/05/2003|||APPR|APPROVAL TO UPDATE THE COMPLIANCE CHARTS TO ENHANCE THE ACCURACY OF THE LABELING FOR THE PC COATED BIODIVYSIO SV AND OC OTW STENT DELIVERY SYSTEMS.
P930031|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2003|09/11/2003|||OK30|CHANGE IN STERILIZATION PARAMETERS FROM 50 DEGREES C PULSED CYCLE TO DART 50 DEGREES C CYCLE.
P940019|S015|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT LLIAC ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2003|09/11/2003|||OK30|CHANGE IN STERILIZATION PARAMETERS FROM 50 DEGREES C PULSED CYCLE TO DART 50 DEGREES C CYCLE.
P980033|S007|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT  VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2003|09/11/2003|||OK30|CHANGE IN STERILIZATION PARAMETERS FROM 50 DEGREES C PULSED CYCLE TO DART 50 DEGREES C CYCLE.
P020045|S002|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2003|10/28/2003|||APPR|APPROVAL FOR MANUFACTURING AND MINOR DESIGN CHANGES TO THE CCT.2 CRYOCONSOLE.
P940015|S010|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC HYLAN G-F 20|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/2003|09/12/2003|||APPR|APPROVAL FOR CHANGES TO THE PATIENT PACKAGE INSERT FOR SYNVISC THAT ARE INTENDED TO STRENGTHEN THE INFORMATION FOR PATIENTS BY INCREASING THE TYPE SIZE, DECREASING THE READING LEVEL, MORE FULLY DESCRIBING THE U.S. CLINICAL TRIAL, DESCRIBING THE SIGNS OF AN ALLERGIC REACTION, AND BY MAKING OTHER REVISIONS TO THE INSERT.
P820060|S019|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER|ABBOTT AXSYM AFP|LOJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|08/14/2003|02/02/2004|||APPR|APPROVAL FOR A CHANGE IN PROTOCOL FOR THE AUTOMATED DILUTION PROTOCOL IN ABBOTT AXSYM SOFTWARE VERSION 3.60 AND VERSION 4.01.
P860019|S198|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NC MONORAIL PTC CATHETER, QUANTUM MONORAIL PTCA CATHETER, MAXXUM PTCA CATHETER, VIVA PTCA CATHETER AND ADANTE PTCA CATHR|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2003|09/03/2003|||OK30|CHANGE IN THE STERILIZATION PARAMETERS.
P950032|S035|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2003|09/15/2003|||OK30|SUBSTITUTION OF THE CURRENT MANUFACTURER (ELI LILLY AND CO., DISTRIBUTED BY GIBCO) TO A DIFFERENT MANUFACTURER (NOVO NORDISK S/A, DISTRIBUTED BY GIBCO).  ALSO, SUBSTITUTING NON-HUMAN COMPONENTS WITH HUMAN COMPONENTS.
P840001|S070|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, SYNERGY AND SYNERGY VERSITREL|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2003|09/17/2003|||APPR|APPROVAL FOR THE RESUME II MODEL 3587A, THE RESUME TL MODEL 3986A, THE ON-POINT MODEL 3987A AND THE SYMMIX MODEL 3982A LEADS.
P010031|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR INSYNC ICD, MODEL 7272 AND INSYNC MARQUIS, M|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2003|09/17/2003|||APPR|APPROVAL FOR THE MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH THE INSYNC ICD MODEL 7272 & INSYNC MARQUIS MODEL 7277.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P890003|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SYNERGYST II PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2003|09/17/2003|||APPR|APPROVAL FOR THE MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH THE INSYNC ICD MODEL 7272 & INSYNC MARQUIS MODEL 7277.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P990046|S008|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS MEDICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2003|09/16/2003|||OK30|ADDITION OF A SOURCE SUPPLIER.
P970043|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/21/2003|09/12/2003|||APPR|APPROVAL FOR THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE TO BE USED WITH THE LADARVISION 4000 EXCIMER LASER SYSTEM WHICH WILL ALLOW TREATMENT PLANNING BY THE PRACTITIONER PRIOR TO THE ACTUAL DATE OF SURGERY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADARVISION 4000 EXCIMER LASER SYSTEM AND IS INDICATED FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE.
P010031|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC INSYNC 11 PROTECT MODEL 7295 WITH THE MODEL 9992 APPLICATION SOFTWARE|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/2003|02/06/2004|||APPR|APPROVAL FOR THE MEDTRONIC INSYNC II PROTECT MODEL 7295 WITH MODEL 9992 APPLICATION SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC INSYNC II PROTECT MODEL 7295 WITH MODEL 9992 APPLICATION SOFTWARE AND IS INDICATED AS FOLLOWS:  THE INSYNC  II PROTECT PROVIDES VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A QRS DURATION >= 130 MS. THE INSYNC II PROTECT DEVICE ONLY ALLOWS ARRHYTHMIAS IN THE VF ZONE TO RECEIVE TREATMENT.  ARRHYTHMIAS IN THE MONITOR ONLY ZONE WILL NOT BE TREATED BY THE DEVICE.
P000018|S035|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/2003|02/17/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE ALPHA-SERIES TRANSFER DEVICES (ALPHA IV, REV. 2, ALPHA V, AND ALPHA VI), AND MODIFICATIONS TO THE LABELING FOR THE BETA-CATH 5F AND BETA-CATH 3.5F SYSTEMS.
P900060|S027|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|09/23/2003|||OK30|ADDITIONAL SUPPLIER OF BOVINE BONES.
P000058|S005|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/22/2003|12/27/2004|||APPR|APPROVAL FOR THE DRAFT PROTOCOL FOR THE RABBIT REPRO/TOX STUDY REQUIRED AS A CONDITIONS OF APPROVAL.  THE PROPOSED STUDY IS DESIGNED TO EVALUATE THE IMPACT OF A MATERNAL IMMUNE RESPONSE ON THE DEVELOPMENT OF OFFSPRING.  THIS IS DETERMINED VIA AN ASSESSMENT OF "ETAL MORTALITY, FETAL WEIGHT, AND FETAL PLACENTAL MORPHOLOGY
P890003|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SYNERGYST PULSE II GENERATOR|DXY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P010031|S009|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MODEL 7272|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P970012|S015|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC. KAPPA 400 SERIES PACEMAKERS|DXY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P980050|S014|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF 7250|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P010015|S011|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM|LWP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P980016|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC. GEM DR MODEL 7271 D|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P970004|S026|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM MODEL 3023 AND TRANSCEND MODEL 3726 IMPLANTABLE NEUROSTIMULATORS|EZW|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P840001|S071|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL (R) TOTALLY IMPLANTABLE|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P980035|S031|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 700/600 SERIES|DXY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P000040|S004|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/2003|02/24/2004|||APPR|APPROVAL FOR UPDATED LABELING THAT REFLECTS THE 2 AND 3 YEAR PATIENT FOLLOW-UP DATA.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTZ SYSTEM AND IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
P990014|S004|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/2003|09/16/2003|||APPR|APPROVAL FOR A NEW TRADE NAME FOR THE HP60M HYDROGEL IOL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME "MERIDIAN" AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE OR OLDER WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.  THE LENS IS DESIGNED FOR IMPLANTATION IN THE CAPSULAR BAG FOLLOWING EXTRACAPSULAR CATARACT EXTRACTION.
P960009|S028|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2003|11/17/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
P970015|S025|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|INTER FIX THREADED FUSION DEVICE|MAX|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/25/2003|09/17/2003|||APPR|APPROVAL FOR A MODIFICATION TO THE APPROVED POST-APPROVAL STUDY.
P830079|S014|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT ABSORBABLE COLLAGEN HEMOSTAT|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/2003|09/26/2003|||APPR|APPROVAL FOR REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSTAT ABSORBABLE COLLAGEN HEMOSTAT AND IS INDICATED FOR USE "IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMOLOGICAL SURGERY) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL PROCEDURES IN INEFFECTIVE OR IMPRACTICAL.  INSTAT HEMOSTAT CAN BE CUT TO SIZE FOR USE IN ENDOSCOPIC PROCEDURES."
P000058|S006|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/26/2003|09/17/2003|||APPR|APPROVAL FOR A RETRIEVED IMPLANT PROTOCOL USED TO OBTAIN DATA TO COMPLY WITH ONE OF THE CONDITIONS OF APPROVAL.
N12159|S019|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL/SURGICEL NU-KNIT/SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2003|11/17/2003|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO.
P000028|S004|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|AFFINITY ANTERIOR CERVICAL CAGE SYSTEM|MAX|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/27/2003|11/13/2003|||APPR|APPROVAL FOR A REVISED EXPLANT PROTOCOL.
P970051|S025|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR ADVANCE|MCM|EN|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/2003|11/07/2003|||APPR|APPROVAL OF A MARKETING NAME CHANGE FROM NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR SOFTIP ELECTRODE TO NUCLEUS 24 CONTOUR ADVANCE.
P990046|S009|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS AVG (AORTIC VALVED GRAFT)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2003|09/23/2003|||OK30|CHANGE IN THE STERILIZATION VALIDATION PROTOCOL FOR THE ATS AVG (AORTIC VALVED GRAFT)
P790018|S044|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVES (MODELS A7700 AND M7700)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2003|09/23/2003|||OK30|ELIMINATION OF THE PRODUCTION PULSE DUPLICATION TEST FROM THE MANUFACTURING PROCESS.
P980035|S032|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/2003|02/20/2004|||APPR|APPROVAL FOR THE ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33, E2D01, E2D03, E2VDD01, E2SR01, E2SR03, E2SR06 WITH ATRIAL CAPTURE MANAGEMENT AND MODEL 9991 APPLICATION SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENPULSE IPG AND IS INDICATED AS FOLLOWS:  ENPULSE PACEMAKERS ARE INDICATED FOR USE IN PATIENTS WHO ARE EXPERIENCING ACCEPTED CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE:  1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK  2) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK  3) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS.  4) BRADYCARDIA-TACHYCARDIA SYNDROME  5) VASOVAGAL SYNDROMES OR HYPERSENSITITVE CAROTID SINUS SYNDROMES.  ENPULSE PACEMAKERS ARE ALSO INDICATED FOR USE IN PATIENTS WHO MAY BENEFIT FROM RATE RESPONSIVE PACING TO SUPPORT CARDIAC OUTPUT DURING VARYING LEVELS OF ACTIVITY.  USING RATE RESPONSE MODES MAY RESTORE HEART RATE VARIABILITY BY IMPROVING CARDIAC OUTPUT.  THESE DEVICES ARE ALSO INDICATED FOR USE IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY THROUGH THE USE OF DUAL CHAMBER MODES AND ATRIAL TRACKING MODES.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY.  DUAL CHAMBER MODES ARE INDICATED FOR USE IN PATIENTS WHO HAVE EXPERIENCED ONE OR BOTH OF THE FOLLOWING CONDITIONS.  1) VARIOUS DEGREES OF AV BLOCK  2) VVI INTOLERANCE (FOR EXAMPLE, PACEMAKER SYNDROME) IN PRESENCE OF PERSISTENT SINUS RHYTHM.  THE DEVICE IS ALSO INDICATED FOR VDD PACING IN PATIENTS WHO HAVE ADEQUATE RATES AND ON OR BOTH OF THE FOLLOWING CONDITIONS.  1) A REQUIREMENT FOR VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT.  THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT OR WHEN...
P010018|S005|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CK SYSTEM|MWD|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/27/2003|03/16/2004|04M-0134|03/23/2004|APPR|APPROVAL FOR THE VIEWPOINT CK SYSTEM.  THE DEVICE IS INDICATED FOR THE TEMPORARY INDUCTION OF MYOPIA (-1.00 D TO -2.00 D) TO IMPROVE NEAR VISION IN THE NON-DOMINANT EYE OF PRESBYOPIC HYPEROPES OR PRESBYOPIC EMMETROPES, VIA SPHERICAL HYPEROPIC TREATMENT OF 1.00 TO 2.25 D, IN PATIENTS:  1) 40 YEARS OF AGE OF GREATER; 2) WITH A DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF <0.50 D IN SPHERICAL AND CYLINDRICAL COMPONENTS OF THE MANIFEST REFRACTION; 3) WITH <=0.75 D OF CYCLOPLEGIC REFRACTIVE CYLINDER; AND 4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION WEAR (I.E., DOMINANT EYE CORRECTED FOR DISTANCE VISION AND NON-DOMINANT EYE CORRECTED FOR NEAR VISION).
P020004|S005|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/2003|02/25/2004|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE GORE EXCLUDER BIFURCATED ENDOPROSTHESIS.
P990066|S016|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/2003|02/19/2004|||APPR|APPROVAL FOR CHANGES IN ERGONOMICS, THE IMAGE ACQUISITION CHAIN, IMAGE PRESENTATION ON THE AWS, AND CONNECTIVITY.  IN ADDITION THE APPLICATION REQUESTED ADDITIONAL IMAGE QUALITY CLAIMS AND QC MANUAL CHANGES FOR QC TEST TECHNIQUE FACTORS AND PROCEDURES UNDER MQSA.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
P970051|S026|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR SOFTIP ELECTRODE|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2003|09/25/2003|||APPR|APPROVAL FOR DECREASING THE RADIUS OF THE MAGNET OPENING IN THE SILICONE FROM 6 MM TO 5.3 MM.
P880047|S008|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED (TC7) ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track No User Fee|Express GMP Supplement|N|09/04/2003|10/21/2003|||APPR|APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS-ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO.
P960043|S048|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/2003|02/11/2004|||APPR|APPROVAL FOR A NAME CHANGE, FROM PERCLOSE AT MONO-GLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM TO PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PERCLOSE PROGLIDE SUTURE MEDIATED CLOSER (SMC) SYSTEMS AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 8 FR. SHEATHS.  THE PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEMS REDUCE THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS.
P980016|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2003|10/06/2003|||APPR|APPROVAL TO MODIFY THE MARQUIS VR AND DR SYSTEMS TO PROVIDE INCREASED ENERGY OUTPUT (35J).  THE DEVICES WILL BE USED WITH THE FOLLOWING APPLICATION SOFTWARE VERSIONS: MODEL 9978 VERSION 1.0 APPLICATION SOFTWARE FOR USE WITH THE MAXIMO DR, AND MODEL 9979 VERSION 1.0 APPLICATION SOFTWARE FOR USE WITH MAXIMO VR.  THE APPLICATION SOFTWARE MAY BE INSTALLED ON EITHER 9790C OR 2090 PROGRAMMERS.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAXIMO DR/VR ICD SYSTEM AND ARE INDICATED AS FOLLOWS:  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P940031|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SOFTWARE APPLICATION MODEL 2890 VERSION 4.10|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2003|10/31/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE SOFTWARE APPLICATIONS FOR THE PULSAR, PULSAR MAX, DISCOVERY, MERIDIAN, CONTAK TR, PULSAR MAX II, AND DISCOVERY II PACEMAKER SYSTEMS.
P960016|S013|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/10/2003|10/03/2003|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO INCLUDE WARNINGS REGARDING PROPER MOVEMENT OF THE CATHETER.
P980049|S010|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ORCHESTRA PROGRAMMER|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/2003|10/14/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE PROGRAMMING HEAD OF THE ORCHESTRA PROGRAMMER, INCLUDING THE ADDITION OF HIGH-SPEED TELEMETRY AND OTHER CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CPR3 PROGRAMMING HEAD AND IS INDICATED FOR USE WITH THE ORCHESTRA DEDICATED PROGRAMMER TO INTERROGATE AND PROGRAM ELA MEDICAL PULSE GENERATORS VIA BI-DIRECTIONAL TELEMETRY.
P960040|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/2003|10/06/2003|||APPR|APPROVAL FOR A FAST-CHARGE VERSION OF THE DEVICE (MODEL A155) AND TO CORRECT SOFTWARE ANOMALIES (MODELS A155 AND A135).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VENTAK VITALITY AVT AICD SYSTEM AND IS INDICATED AS FOLLOWS:  THE VITALITY AVT AICD SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE ICD INDICATED AND WHO HAVE ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS; OR, PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <=30%.
P910023|S069|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|ATLAS+ DR/BR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/2003|10/17/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC+ ICDS TO INCLUDE HIGHER ENERGY OUTPUT, SOFTWARE MODIFICATIONS, AND A DIFFERENT HEADER TYPE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODELS V-242, V-243, V-193 AND V-193C, EPIC+ MODELS V-233, V-239 AND V196, AND MODEL 3307 V.4.5A SOFTWARE, AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATIONS
P880086|S096|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND MODEL 3307 V.4.5A SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/2003|10/17/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC+ ICDS TO INCLUDE HIGHER ENERGY OUTPUT, SOFTWARE MODIFICATIONS, AND A DIFFERENT HEADER TYPE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODELS V-242, V-243, V-193 AND V-193C, EPIC+ MODELS V-233, V-239 AND V196, AND MODEL 3307 V.4.5A SOFTWARE, AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATIONS
P830045|S088|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/2003|10/17/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC+ ICDS TO INCLUDE HIGHER ENERGY OUTPUT, SOFTWARE MODIFICATIONS, AND A DIFFERENT HEADER TYPE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODELS V-242, V-243, V-193 AND V-193C, EPIC+ MODELS V-233, V-239 AND V196, AND MODEL 3307 V.4.5A SOFTWARE, AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATIONS
P900056|S078|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTAWIRE FLOPPY GOLD GUIDE WIRE|MCX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2003|10/22/2003|||APPR|APPROVAL FOR CHANGES TO THE ROTAWIRE GOLD PLATING MANUFACTURING EQUIPMENT AND MONITORING.
P000018|S036|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2003|10/09/2003|||OK30|CHANGE IN THE BETA-CATH TRANSFER DEVICES INSPECTION PROCESS.
P000018|S037|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2003|10/09/2003|||OK30|CHANGE IN THE HYDRAULIC PRESSURE USED IN THE FUNCTIONAL SOURCE TRAIN TRANSPORT INSPECTION OF THE DELIVERY CATHETER.
P000016|S002|GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES|8880 GORMAN ROAD||LAUREL|MD|20723||OXIMETER, FETAL PULSE|COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING|MMA|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/2003|10/15/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING.
P980023|S016|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|KENTROX SL ICD LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2003|03/12/2004|||APPR|APPROVAL FOR CHANGES IN COMPONENT DIMENSIONS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME KENTROX SL AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD.  CURRENTLY, DATA IS NOT AVAILABLE REGARDING THE USE OF THIS LEAD SYSTEM WITH ICDS OF OTHER MANUFACTURERS.  USE OF OTHER ICDS MAY ADVERSELY AFFECT SENSING AND/OR THERAPY DELIVERY.
P810046|S214|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||CATHETER, FLOW DIRECTED|VOYAGER OTW CORONARY DILATION CATHETER|DYG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2003|03/12/2004|||APPR|APPROVAL FOR A NEW CORONARY DILATATION CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER OTW CORONARY DILATATION CATHETER AND IS INDICATED FOR  1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, 3) BALLOON DILATATION OF A STENT AFTER IMPLANTATION.
P830055|S087|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2003|11/18/2003|||APPR|APPROVAL FOR A LINE EXTENSION TO THE P.F.C. SIGMA COMPONENTS.  THAT IS, THE ADDITION OF P.F.C. SIGMA RPF FEMORAL COMPONENTS AND TIBIAL BEARINGS (SIZES 1, 1.5, 2, 2.5, 3, 4, 5, AND 6).  THE P.F.C. SIGMA RPF COMPONENTS ALLOW FOR A HIGHER THAN NORMAL DEGREE OF FLEXION AFTER TOTAL KNEE ARTHROPLASTY (~155 DEGREES).
P970003|S048|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/2003|10/22/2003|||APPR|APPROVAL FOR A CHANGE TO THE PRECAUTION REGARDING BRADYCARDIA AND/OR ASYSTOLE.
P020018|S001|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|09/22/2003|02/02/2004|||APPR|APPROVAL FOR THE LONG-TERM STUDY OF THE DEVICE.
P980049|S011|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ORCHESTRA PROGRAMMER|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/23/2003|10/21/2003|||APPR|APPROVAL FOR THE ORCHESTRA APPLICATION SOFTWARE (ELAVIEW 1.20 UG1) WHICH ALLOWS HIGH-SPEED TELEMETRY AND CORRECT MINOR ANOMALIES.
P020025|S001|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP CARDIAC ABLATION SYSTEM|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2003|02/23/2004|||APPR|APPROVAL FOR THE BLAZER XP RPM CATHETER WHICH COMBINES THE FEATURES OF THE BLAZER II XP WITH THE REAL TIME POSITION MANAGEMENT (RPM) TRACKING SYSTEM TECHNOLOGY APPROVED FOR THE CHILLI RPM CATHETER.
P820088|S017|PYREXAR MEDICAL INC|2188 WEST 2200 SOUTH|SUITE A|SALT LAKE CITY|UT|84119||System, rf/microwave hyperthermia, cancer treatment|BSD-500 HYPERTHERMIA SYSTEM|LOC|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/2003|01/20/2004|||APPR|APPROVAL TO REPLACE THE GENERATOR APPROVED IN PMA P820088/S005.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, BSD-500 HYPERTHERMIA SYSTEM AND IS INDICATED FOR TREATMENT OF SOLID MALIGNANT TUMORS BY LOCALIZED HEAT DELIVERY.
P950019|S016|STRYKER SPINE|2 Pearl Court||Allendale|NJ|07401||Intervertebral fusion device with bone graft, lumbar|RAY TFC UNITE|MAX|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2003|10/10/2003|||APPR|APPROVAL FOR LABELING CHANGES (CHANGE OF ADDRESS, CHANGE IN CE MARK, ADDITIONAL PATENT STATEMENT) AND CHANGES IN PART NUMBERS.
P800022|S052|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|COSMODERM AND COSMOPLAST HUMAN-BASED COLLAGEN|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/2003|05/11/2004|||APPR|APPROVAL FOR A NEW RAW MATERIAL SUPPLIER FOR THE HUMAN COLLAGEN COMPONENT OF COSMODERM AND COSMOPLAST (I.E., IMMUCOR/GAMMA BIOLOGICALS OF HOUSTON, TEXAS).
P950002|S012|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK VISTA INTERBODY FUSION CAGE|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2003|10/31/2003|||APPR|APPROVAL TO ADD THE 9MM X 20MM BAK VISTA INTERBODY FUSION DEVICE, WHICH IS MANUFACTURED FROM 65% PEEK OPTIMA AND 35% TOHO BESFIGHT C6-UH CARBON FIBER, TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME BAK VISTA INTERBODY FUSION DEVICE AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L2-S1 LEVELS.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S).  BAK DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR POSTERIOR APPROACH.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.  THESE PATIENTS WOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.
P020027|S001|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/29/2003|10/10/2003|||APPR|APPROVAL OF THE FOLLOWING MODIFICATIONS TO THE DIMENSION FPSA FLEX REAGENT CARTRIDGE:  1) ADDITION OF LITHIUM HEPARIN PLASMA AS A SAMPLE TYPE IN THE INTENDED USE AND THE PACKAGE LABELING.  2) ADDITION OF THE DISCLAIMER "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS" TO THE RESULTS SECTION OF THE PACKAGE LABELING.  3) CORRECTION OF THE UNITS FOR IGG IN THE PACKAGE LABELING FROM 6 G/ML TO 6 G/DL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, DIMENSION FPSA FLEX REAGENT CARTRIDGE AND IS INDICATED AS FOLLOWS:  THE FPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE FREE PROSTATE SPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM AND PLASMA.  MEASUREMENTS OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) ON THE DIMENSION SYSTEM TO CALCULATE FPSA TO TPSA RATIO EXPRESSED AS PERCENT FPSA.  THE PERCENT FPSA IS USED AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATE CONDITIONS IN MEN 50 YEARS OR OLDER WITH TPSA OF 4.0 TO 10/0 NG/ML (UG/L) AND DIGITAL RECTAL EXAMINATION (DRE) FINDINGS NOT SUSPICIOUS FOR CANCER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER.
P000009|S010|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS AND CARDIAC AIRBAG FAMILIES|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2003|10/14/2003|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE CHANGES TO CORRECT ANOMALOUS BEHAVIOR FOR THE BELOS AND CARDIAC AIRBAG FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS.
P970043|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2003|06/29/2004|04M-0312|07/16/2004|APPR|APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM.  THE DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.00 MM ABLATION ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -9.75 DIOPTERS (D) SPHERE, -5.00D CYLINDER, AND -10.63D SPHERICAL EQUIVALENT (SE), AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK):  1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -8.00D SPHERE WITH -0.50 TO -4.00D CYLINDER AND UP TO -8.00D SE AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE IN SPHERE AND CYLINDER OF LESS THAN OR EQUAL TO 0.50D FOR A SE OF UP TO -6.00D AND LESS THAN OR EQUAL TO 0.75D FOR A SE GREATER THAN -6.00D.
P000052|S021|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS|MOU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2003|03/04/2004|||APPR|APPROVAL FOR A CHANGE TO THE P-32 SOURCE WIRE MANUFACTURING PROCESS TO INCORPORATE AN AUTOMATED SOURCE WIRE ASSEMBLY STATION (SWAS) AS AN ALTERNATE PROCESS FOR FINAL ASSEMBLY OF P-32 SOURCE WIRES.
P950032|S036|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2003|10/24/2003|||OK30|CHANGE FROM INDIVIDUAL MEDIUM COMPONENTS TO A BULK MEDIUM FORMULATION AND CHANGE IN THE METHOD OF DELIVERING THE KERATINOCYTES TO FORM A BILAYERED DERMAL-EPIDERMAL CONSTRUCT.
P850022|S015|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2003|01/12/2004|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE BIOELECTRON SPINALPAK FUSION STIMULATOR.  THE MODIFICATIONS ARE:  1) THE CURRENT SPINALPAK IS POWERED BY 1 ALKALINE 9 VOLT BATTERY THAT MUST BE REPLACED DAILY.  THE MODIFIED VERSION WILL BE POWERED BY 1 NIMN "AA" RECHARGEABLE CELL.  THE CHARGER WILL BE INCLUDED.  2) THE HOUSING HAS BEEN MODIFIED TO ACCOMMODATE FOR A RECHARGEABLE BATTERY AND AN LCD DISPLAY.  THE CURRENT SPINALPAK HAS AN LED DISPLAY.  THE MODIFIED VERSION WILL HAVE A 6 MESSAGE LCD DISPLAY.  3) THE PCB CIRCUITRY HAS BEEN MODIFIED TO ACCOMMODATE THE LCD DISPLAY AND THE RECHARGEABLE BATTERY PACK.  4) THE ORIGINAL SOFTWARE WAS WRITTEN IN ASSEMBLY CODE.  THE MODIFIED VERSION WAS REWRITTEN IN C.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
P890064|S013|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST|MAQ|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2003|11/07/2003|||APPR|APPROVAL FOR:  1) MODIFICATION OF HYBRIDIZATION PROCEDURAL STEPS AND SEQUENCE;  THIS MODIFICATION ENTAILS REVERSING THE ADDITION ORDER OF THE HPV RNA PROBES AND DENATURED SPECIMEN WITH NO CHANGE IN PROBE OR SPECIMEN VOLUME.  AN ADDITIONAL 10 MINUTE INCUBATION PERIOD AT ROOM TEMPERATURE (15 DEGREES C TO 30 DEGREES C) WAS ADDED AFTER REMOVAL OF THE SPECIMEN FROM THE 65 += 2 DEGREES C, 60 MINUTES HYBRIDIZATION INCUBATION STEP.  2) ADDITION OF AN EQUIVOCAL RESULT ZONE, WHICH REQUIRES REPEATING SPECIMENS THAT HAVE RESULTS WITHIN THIS RESULT ZONE, FOR SPECIMENS COLLECTED IN PRESERVCYT TRANSPORT MEDIUM.  THIS EQUIVOCAL RESULT ZONE HAS BEEN ESTABLISHED TO BE >=1.0 AND <+ 2.5 RLU/CO.  3)_ REMOVAL OF THE EQUIVOCAL RESULT ZONE FROM SPECIMENS COLLECTED IN THE DIGENE SPECIMEN TRANSPORT MEDIUM.
P990026|S021|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY|GLUCOWATCH G2 BIOGRAPHER|NCT|CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2003|02/25/2004|||APPR|APPROVAL FOR AN EXPANSION OF THE LABELING TO INCLUDE A DESCRIPTION OF PRE-TREATMENT PRODUCTS AND A METHOD TO MINIMIZE THE AFFECTS OF SKIN IRRITATION WITHOUT AFFECTING THE ACCURACY OF G2 BIOGRAPHER GLUCOSE MEASUREMENTS.
P020009|S011|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2003|10/28/2003|||OK30|CHANGE TO PARTIAL AUTOMATION OF THE STENT FINISHING PROCESS.
P020047|S001|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK RX AND OTW VISION CORONARY STENT SYSTEMS|MAF|CV|Special (Immediate Track)||N|10/02/2003|10/08/2003|||APPR|APPROVAL FOR THE ADDITION OF A TEMPORARY, POST-STERILE SAMPLING INSPECTION PLAN FOR THE SMALL (3.0 MM DIAMETER) MULTI-LINK VISION CORONARY STENT SYSTEM.
P010049|S009|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/2003|12/23/2003|||APPR|APPROVAL TO REDUCE THE MINIMUM REQUIRED ACCESS SITE DEPTH FROM 3 CENTIMETERS TO 2 CENTIMETERS IN THE INSTRUCTIONS FOR USE.
P000018|S038|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2003|10/14/2003|||OK30|CHANGE IN THE SUPPLIERS OF TWO COMPONENTS USED IN THE ROUTINE MAINTENANCE AND SERVING OF THE ALPHA TRANSFER DEVICES.
P990054|S005|Boston Scientific Corp.|2710 ORCHARD PKWY.||SAN JOSE|CA|95113||Cardiac ablation percutaneous catheter|CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/02/2003|02/09/2004|||APPR|APPROVAL FOR THE USE OF THE CHILLI AND CHILLI RPM CATHETERS WITH THE EPT-1000 XP RF GENERATOR USING THE SAME MAXIMUM OUTPUT POWER AS THAT USED WITH THE MODEL 8004 AND EPT-1000 TC GENERATORS.
P980003|S009|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/02/2003|02/05/2004|||APPR|APPROVAL FOR THE USE OF THE CHILLI CATHETERS WITH THE EPT-1000 XP RF GENERATOR USING THE SAME MAXIMUM OUTPUT POWER AS THAT USED WITH THE MODEL 8004 AND EPT-1000 TC GENERATORS.
P010034|S005|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/03/2003|10/08/2003|||APPR|APPROVAL FOR THE USE OF THE SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY WITH THE FISHER IMAGING'S SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
P020009|S012|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS|MAF|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2003|10/24/2003|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST TO EVALUATE THE ELONGATION PROPERTY OF THE EXTRUDED DISTAL OUTER SHAFT COMPONENT FOR THE EXPRESS2 STENT DELIVERY CATHETER.
P970051|S027|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH NUCLEUS 24 CONTOUR ADVANCE/SOFTIP II ELECTRODE AND INSERTION TOOL|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2003|05/18/2004|||APPR|APPROVAL FOR AN ELECTRODE INSERTION TOOL TO FACILITATE PLACEMENT OF THE ELECTRODE INTO THE COCHLEA AS WELL AS MINOR MODIFICATIONS TO THE SOFTIP ELECTRODE TO OPTIMIZE ITS INTERACTION WITH THE INSERTION TOOL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSERTION TOOL FOR THE NUCLEUS 24 CONTOUR ADVANCE/SOFTIP ELECTRODE II.
P020018|S002|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/2003|02/12/2004|||APPR|APPROVAL TO INCREASE THE DIAMETER OF THE SUPRARENAL ATTACHMENT BARB (FROM .0093 INCHES TO .011 INCHES) OF THE ZENITH AAA ENDOVASCULAR GRAFT.
P980016|S038|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 7232|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/07/2003|10/23/2003|||APPR|APPROVAL FOR BATTERY CHANGES TO THE CHI 4420L BATTERY IN THE MEDTRONIC MARQUIS DR MODEL 7274, MARQUIS VR MODEL 7230, MAXIMO DR MODEL 7278, MAXIMO VR MODEL 7232, INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289.
P010031|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2003|10/23/2003|||APPR|APPROVAL FOR BATTERY CHANGES TO THE CHI 4420L BATTERY IN THE MEDTRONIC MARQUIS DR MODEL 7274, MARQUIS VR MODEL 7230, MAXIMO DR MODEL 7278, MAXIMO VR MODEL 7232, INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289.
P010013|S006|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2003|02/05/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT NOVACEPT, HEREDIA, COSTA RICA.
P010012|S016|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK RENEWAL AND CONTAK RENEWAL 3|NIK|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/2003|10/24/2003|||APPR|APPROVAL FOR LABELING CHANGES TO THE SYSTEM GUIDE AND TECHNICAL MANUALS FOR THE CONTAK RENEWAL AND CONTAK RENEWAL 3 SYSTEMS.
P880086|S097|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYNCHRONY MODEL 2020T PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/07/2003|10/31/2003|||APPR|APPROVAL FOR MODIFICATION TO THE MODEL 3510 PROGRAMMER PLATFORM BY ADDING A VIDEO DISPLAY OUT PORT AND THE ADDITION OF A NEW VIDEO CABLE, MODEL 3134.
P830045|S089|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/07/2003|10/31/2003|||APPR|APPROVAL FOR MODIFICATION TO THE MODEL 3510 PROGRAMMER PLATFORM BY ADDING A VIDEO DISPLAY OUT PORT AND THE ADDITION OF A NEW VIDEO CABLE, MODEL 3134.
P910023|S071|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/07/2003|11/06/2003|||APPR|APPROVAL FOR MODIFICATIONS TO THE HOUSECALL 2.0 SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM AND IS INDICATED AS FOLLOWS:   THE HOUSECALL PLUS SYSTEM IS INDICATED FOR USE IN PERFORMING REMOTE FOLLOW-UP MONITORING ON PATIENTS HAVING THE FOLLOWING ST. JUDE MEDICAL CARDIOVERTER/ DEFRIBRILLATORS:  ATLAS DR MODEL V-240, ATLAS VR MODEL V-199, EPIC+ DR MODEL V-236, EPIC+ VR MODEL V-1961, EPIC DR MODEL V-235 AND EPIC VR MODEL V-197.
P790019|S017|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|IMX HAVAB -M (LIST NUMBER 2263)|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2003|11/06/2003|||OK30|DISCONTINUE THE USE OF REFERENCE PANEL 4 AND ELIMINATE ALL ASSOCIATED VALIDITY AND ACCEPTANCE CRITERIA FROM BOTH THE INCOMING ALKALINE PHOSPHATASE AND THE IMX HAVAB-M CONJUGATE CONCENTRATE TESTING.
P960052|S007|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND TOPICAL SKIN ADHESIVE|MPN|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/09/2003|12/01/2003|||APPR|APPROVAL FOR A LABELING CHANGE TO MODIFY A WARNING STATEMENT (6TH BULLET) TO READ, "HIGH VISCOSITY DERMABOND ADHESIVE SHOULD NOT BE USED IN HIGH SKIN TENSION AREAS OR ACROSS AREAS OF INCREASED SKIN TENSION, SUCH AS KNUCKLES, ELBOWS, OR KNEES, UNLESS THE JOINT WILL BE IMMOBILIZED DURING THE SKIN HEALING PERIOD OR UNLESS SKIN TENSION HAS BEEN REMOVED BY APPLICATION OF ANOTHER WOUND CLOSURE DEVICE (E.G., SUTURES OR SKIN STAPLES) PRIOR TO THE APPLICATION OF HIGH VISCOSITY DERMABOND ADHESIVE."
P020024|S001|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM|MAE|CV|30-Day Notice||N|10/14/2003|11/13/2003|||OK30|ALTERNATE MANUFACTURING VENDOR FOR THE AMPLATZER 180 DELIVERY AND EXCHANGE SYSTEM.
P000013|S003|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/13/2003|11/13/2003|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.
P920023|S017|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOURETHRAL PROSTHESIS|MES|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/16/2003|11/14/2003|||APPR|APPROVAL FOR CHANGES TO THE LABELING REGARDING THE DEPLOYMENT OF THE DEVICE AND WITHDRAWAL OF THE DELIVERY INSTRUMENT.
P850020|S019|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA COLUMN|LKN|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|10/17/2003|04/14/2004|||APPR|APPROVAL FOR SEVERAL CHANGES TO THE RA-4 POST-APPROVAL STUDY PROTOCOL.  SPECIFICALLY, THESE ARE: 1) A CHANGE IN INCLUSION CRITERION 6 TO ALLOW THE ENROLLMENT OF PATIENTS WHO HAVE BEEN ON METHOTREXATE (>= 15 MG/WEEK) FOR AT LEAST THREE MONTHS PRIOR TO SCREENING, RATHER THAN SIX MONTHS PRIOR TO SCREENING; 2) THE ADDITION OF AN INCLUSION CRITERION TO ALLOW THE ENROLLMENT OF PATIENTS WHO HAVE HAD TOXICITY TO METHOTREXATE AT A DOSE OF >= 15 MG/WEEK IF THEY CAN BE ON A DOSE OF 12.5 MG/WEEK; 3) THE INCLUSION OF PATIENTS RECEIVING CONCOMITANT TREATMENT WITH OTHER DISEASE-MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS); AND 4) THE INCLUSION OF PATIENTS WITH 12 OR MORE JOINTS TENDER OR PAINFUL ON MOTION OR PRESSURE, RATHER THAN 16 SUCH JOINTS.
P990045|S005|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-COREK PLUS ASSAY|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2003|11/26/2003|||APPR|APPROVAL FOR EXTENSION OF THE ETI-AB-COREK PLUS ASSAY EXPIRATION DATING FROM 7 MONTHS AND A MINOR LABELING CHANGE IN THE ANALYTICAL SENSITIVITY SECTION OF THE PACKAGE INSERT TO CORRECT A CALCULATION ERROR.
P970003|S049|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/2003|11/20/2003|||APPR|APPROVAL FOR CHANGES TO SIMPLIFY THE LANGUAGE IN THE PATIENT'S MANUAL.
P970058|S018|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2003|11/26/2003|||APPR|APPROVAL FOR THE USE OF THE IMAGECHECKER SYSTEM WITH THE FISCHER IMAGING'S SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER D (DIGITAL MAMMOGRAPHY ONLY), IMAGECHECKER DM (DIGITAL AND ANALOG MAMMOGRAPHY), AND IMAGECHECKER OEM-D (DIGITAL MAMMOGRAPHY ONLY, SOLD BY FFDM VENDOR).  THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.1.  THE INDICATIONS FOR USE ARE:  THE IMAGECHECKER D/DM.OEM-D IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P990023|S002|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/2003|11/14/2003|||APPR|APPROVAL FOR ADDING THE PRECAUTION, "USE ONLY IF THE CONTAINER IS UNDAMAGED".
P970003|S050|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|10/27/2003|07/15/2005|05M-0283|07/18/2005|APPR|APPROVAL FOR THE VNS THERAPY SYSTEM.  THE DEVICE IS INDICATED FOR THE ADJUNCTIVE LONG-TERM TREATMENT OF CHRONIC OR RECURRENT DEPRESSION FOR PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE EXPERIENCING A MAJOR DEPRESSIVE EPISODE AND HAVE NOT HAD AN ADEQUATE RESPONSE TO FOUR OR MORE ADEQUATE ANTIDEPRESSANT TREATMENTS.
P960043|S049|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/27/2003|11/25/2003|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE.  THESE CHANGES STRENGTHEN THE PROCEDURAL INSTRUCTIONS FOR USING THE DEVICE AND ADD A PRECAUTION TO NOT USE EXCESSIVE FORCE OR TORQUE TO ADVANCE THE DEVICE, STATING THAT SUCH ACTIONS MAY RESULT IN: "IGNIFICANT ARTERIAL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE SURGICAL REMOVAL OF THE DEVICE AND ARTERIAL REPAIR."  IN ADDITION TO THESE LABELING CHANGES, YOU HAVE ALSO INDICATED THAT THE PHYSICIAN TRAINING PROTOCOL HAS BEEN REVISED TO FURTHER ADDRESS THIS CONCERN.
P920047|S020|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2003|11/25/2003|||OK30|ELIMINATION OF A CHEMICAL FROM THE RING CLEANING PROCEDURE AND THE IMPLEMENTATION OF THE NEW AUTOMATED UV CURING FIXTURE.
P860022|S055|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens,contact(rigid gas permeable)-extended wear|BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR|MWL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/28/2003|11/25/2003|||APPR|APPROVAL FOR COMBINING THE DAILY WEAR AND EXTENDED WEAR LABELING OF THE DEVICE TO BRING THE EXTENDED WEAR LABELING INTO ALIGNMENT WITH THE DAILY WEAR LABELING.
P020036|S001|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2003|05/12/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CORDIS DE MEXICO, CHIHUAHUA, MEXICO.
P830060|S052|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942)|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/30/2003|11/21/2003|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE TEXT VERSIONS AND MORE DESCRIPTIVE APPLICATION DIAGRAMS FOR USING THE BI-DIRECTIONAL TORQUE WRENCH (MODEL 6942) AND HEX WRENCH (MODEL 6501).  THE NEW LABELING ALSO SPECIFIED THAT THE DEVICE IS STERILIZED, NON-PYROGENIC AND SINGLE USE ONLY.
P930035|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|HEX WRENCH(MODEL 6501)|LWS|CV|Special (Immediate Track)||N|10/30/2003|11/21/2003|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE TEXT VERSIONS AND MORE DESCRIPTIVE APPLICATION DIAGRAMS FOR USING THE BI-DIRECTIONAL TORQUE WRENCH (MODEL 6942) AND HEX WRENCH (MODEL 6501).  THE NEW LABELING ALSO SPECIFIED THAT THE DEVICE IS STERILIZED, NON-PYROGENIC AND SINGLE USE ONLY.
P980040|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2003|12/15/2003|||APPR|APPROVAL FOR CHANGES TO THE ACRYLIC BUTTON ANNEALING CYCLE.
P020025|S002|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 CARDIAC ABLATION SYSTEM|OAD|CV|Normal 180 Day Track No User Fee|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2003|12/31/2003|||APPR|APPROVAL FOR A STERILIZATION FACILITY LOCATED AT COSMED OF RHODE ISLAND, INC., COVENTRY, RHODE ISLAND.
P010068|S002|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/2003|01/14/2004|||APPR|APPROVAL FOR MODIFICATIONS MAD TO THE NAVISTAR DS 8MM TIP DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER APPROVED UNDER P010068 AND THE QWIKSTAR 4 MM DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER APPROVED UNDER P990025/S004.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER AND IS INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING) AND WHEN USED WITH THE STOCKERT 70 RF GENERATOR (SOFTWARE VERSION 1.033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS 18 YEARS OR OLDER.
P860004|S057|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC MODEL 8749 INTRATHECAL CATHETER|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/2003|11/18/2003|||APPR|APPROVAL FOR THE CHANGES TO THE MODEL 8731 INTRATHECAL CATHETER TO INCLUDE  1) A CHANGE TO THE LENGTH OF PROXIMAL AND DISTAL SEGMENTS OF THE CATHETER;  2) A CHANGE TO THE TUBING CONNECTOR,  3) REVISIONS TO MODEL 8596 AND MODEL 8749 REVISION KITS,  4) REVISIONS TO THE CATHETER TUBING SPECIFICATIONS; AND 5) ADDITION OF A CRIMP SLEEVE TO THE GUIDE WIRE.
P950037|S036|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2003|03/31/2004|||APPR|APPROVAL FOR ADDITIONAL FEATURES ADDED TO THE PHILOS FAMILY OF PACEMAKERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS II AND IS INDICATED AS FOLLOWS: RATE-ADAPTIVE PACING WITH THE PHILOS II PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.PHILOS II SLR PULSE GENERATORS ARE PRIMARILY INTENDED TO PROVIDE VDD OR VDDR PACING FOR PATIENTS WITH A HEALTHY SINUS NODE AND AV CONDUCTION ABNORMALITIES.  THESE MODES ARE INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT.  THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN: 1) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT AND 2) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED. ADDITIONAL INDICATIONS INCLUDE NORMAL SINUS RHYTHM AND NORMAL AV CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT.
P950039|S011|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2003|02/09/2004|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE FOR THE FILTER MANUFACTURING PROCESS.  THE SITE IS LOCATED AT CYTYC NEW HAMPSHIRE, LONDONDERRY, NEW HAMPSHIRE.
P920047|S021|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETHER, STEEROCATH-A CARDIAC ABLATION CATHETER,STEEROCATH-T CARDIAC ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2003|12/31/2003|||APPR|APPROVAL FOR A STERILIZATION FACILITY LOCATED AT COSMED OF RHODE ISLAND, INC., COVENTRY, RHODE ISLAND.
P990054|S006|Boston Scientific Corp.|2710 ORCHARD PKWY.||SAN JOSE|CA|95113||Cardiac ablation percutaneous catheter|CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2003|12/31/2003|||APPR|APPROVAL FOR A STERILIZATION FACILITY LOCATED AT COSMED OF RHODE ISLAND, INC., COVENTRY, RHODE ISLAND.
P980003|S010|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2003|12/31/2003|||APPR|APPROVAL FOR A STERILIZATION FACILITY LOCATED AT COSMED OF RHODE ISLAND, INC., COVENTRY, RHODE ISLAND.
P020035|S001|St. Jude Medical, Inc.|6500 WEDGWOOD RD.||MAPLE GROVE|MN|55311||Device, hemostasis, vascular|X-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2003|12/18/2003|||APPR|APPROVAL FOR A NEW ACCESSORY THAT INCORPORATES THE KNOT PUSHER AND SUTURE CUTTER ACCESSORIES INTO A SINGLE DEVICE.  THIS NEWLY CREATED ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME X-PRESS TRIMMER, WHICH ALLOWS THE OPERATOR TO PUSH THE CLINCH KNOT AND CUT THE SUTURE BELOW THE SKIN LINE FOLLOWING THE USE OF THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM.
P990071|S004|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|STOCKERT 70 RADIOFREQUENCY GENERATOR|DRF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/05/2003|02/24/2004|||APPR|APPROVAL FOR THE ADDITION OF A STOCKERT REMOTE CONTROL AND CONNECTION CABLE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STOCKERT REMOTE CONTROL AND CONNECTION CABLE AND IS INDICATED FOR USE IN CONJUNCTION WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR TO BE USED IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES.
P000018|S039|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2003|11/18/2003|||OK30|NEW SUPPLIER FOR THE PRESSURE INDICATOR PRINTED CIRCUIT BOARD ASSEMBLY (PIB).
P010013|S007|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/2003|12/05/2003|||APPR|APPROVAL FOR A CHANGE TO A WARNING IN THE LABELING REGARDING UTERINE PERFORATIONS.
P890064|S014|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/2003|05/04/2004|||APPR|APPROVAL TO INCLUDE THE OPTIONAL USE OF AN AUTOMATED, HIGH-THROUGHPUT ROBOTIC PIPETTING AND MICROPLATE HANDLING SYSTEM KNOWN AS THE DIGENE RAPID CAPTURE SYSTEM (RCS).
P920015|S029|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6949 AND 6931 LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/06/2003|06/08/2004|||APPR|APPROVAL FOR THE ADDITION OF A POLYURETHANE OVERLAY.
P900033|S010|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2003|12/04/2003|||OK30|ADDING AN ALTERNATE MATERIAL VENDOR FOR PRIMARY FOIL POUCH PACKAGING.
P880070|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|MODEL HSM65 UV ABSORBING PMMA ANTERIOR CHAMBER LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2003|03/17/2004|||APPR|APPROVAL TO CHANGE THE MATERIAL AND THE MANUFACTURING PROCESS, TO ADD A HEPARIN SURFACE MODIFICATION, AND TO CHANGE THE LENS MODEL DESIGNATION FORM UV65B TO HSM65.
P020009|S013|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2003|12/10/2003|||OK30|CHANGE TO THE MANUFACTURING PROCESS INVOLVING THE FULL AUTOMATION OF THE STENT FINISHING PROCESS (CLEANING AND ELECTROPOLISHING) FOR THE STENT COMPONENT FOR THE EXPRESS/ EXPRESS2 CORONARY STENT SYSTEM.
P970043|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADAR VISION 4000 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/10/2003|02/09/2004|||APPR|APPROVAL FOR A NEW LASER ASSEMBLY SYSTEM TO REPLACE THE EXISTING ASSEMBLY IN THE APPROVED LADARVISION 4000 EXCIMER LASER SYSTEM.
P020014|S005|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/10/2003|06/10/2004|||APPR|APPROVAL FOR THE DEVICE LABELING TO INCLUDE 3-YEAR EFFECTIVENESS RESULTS AND OTHER LABELING CHANGES.
P020006|S001|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MAILSTOP: MB-16|MARLBOROUGH|MA|01752||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|ENTERYX PROCEDURE KIT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2003|11/26/2003|||OK30|MODIFY THE METHOD OF CAPPING THE VIALS OF ENTERYX AND DMSO AND MODIFY THE OVERLAYING PROCESS.
P990028|S007|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Mesh, surgical, polymeric|FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT|FTL|AN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2003|12/04/2003|||APPR|APPROVAL FOR COMPLAINT RETURN AND INVESTIGATION OPERATIONS TO BE TRANSFERRED FROM THE GENZYME FACILITY IN LEXINGTON, MASSACHUSETTS TO THE GENZYME FACILITY IN FARMINGHAM, MASSACHUSETTS.
P990033|S005|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY|NPZ|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/2003|03/15/2004|||APPR|APPROVAL FOR: 1) THE ADDITION OF A PASTE FORM OF PEPGEN P-15,  2) MODIFICATION OF THE DEVICE LABELING FOR ALL PEPGEN P-15 DEVICES, AND  3) CHANGING OF THE CONTRACT MANUFACTURER FOR THE DEVICE CARRIER TO HYALURON, INC., WOBURN, MASSACHUSETTS.
P790018|S045|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT|LWQ|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|11/12/2003|11/28/2003|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTEST LABORATORIES, INC. MINNEAPOLIS, MINNESOTA.
P970043|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM|LZS|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/12/2003|11/21/2003|||APPR|APPROVAL FOR LABELING CHANGES TO THE SURGERY PLANNING SOFTWARE.
P970003|S051|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2004|04/29/2004|||APPR|APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS (HYDROGEN PEROXIDE GAS PLASMA USING THE STERRAD 200 GMP STERILIZER) FOR THE MODEL 302 LEAD AND MODEL 502 ACCESSORY PACK AND APPROVAL FOR A THREE YEAR SHELF LIFE FOR THE MODEL 302 LEAD AND MODEL 502 ACCESSORY PACK.
P010032|S009|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2003|01/20/2004|||APPR|APPROVAL FOR THE USE OF THE AXXESS PERCUTANEOUS LEAD MODELS 4143, 4146, 4153 AND 4156 WITH THE ANS GENESIS NEUROSTIMULATION (IPG) MODEL 3608, THE ANS GENESIS XP NEUROSTIMULATION (IPG) MODEL 3609, THE ANS GENESIS DUAL XP NEUROSTIMULATION (IPG) MODEL 3644 AND THE ANS GENESIS G4 NEUROSTIMULATION (IPG) MODEL 3604 WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P010065|S002|E MED FUTURE|354 S. CLAY STREET||MILLERSBURG|OH|44654||Device, needle destruction|NEEDLE ZAP|MTV|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2003|02/05/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FRANTZ MEDICAL DEVELOPMENT, LTD., MENTOR, OHIO.
P960040|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/12/2003|02/06/2004|||APPR|APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE AND CLINICAL STUDY SECTION LABELING.  THE DEVICES ARE INDICATED FOR:  FOR ICDS (VENTAK PRX, MINI, VITALITY, VENTAK AV AND PRIZM): GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  FOR VITALITY AVT:GUIDANT VITALITY AVT IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THIS DEVICE IS ALSO INTENDED TO PROVIDE ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT IN PATIENTS WHO HAVE OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.FOR CRT-DS (CONTAK CD AND RENEWAL):GUIDANT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  GUIDANT CRT-DS ARE ALSO INDICATED FOR REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) IN PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF    <= 35%) AND QRS DURATION >= 120 MS.
P910077|S041|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2003|02/06/2004|||APPR|APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE AND CLINICAL STUDY SECTION LABELING.  THE DEVICES ARE INDICATED FOR:  FOR ICDS (VENTAK PRX, MINI, VITALITY, VENTAK AV AND PRIZM): GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  FOR VITALITY AVT:GUIDANT VITALITY AVT IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THIS DEVICE IS ALSO INTENDED TO PROVIDE ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT IN PATIENTS WHO HAVE OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.FOR CRT-DS (CONTAK CD AND RENEWAL):GUIDANT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  GUIDANT CRT-DS ARE ALSO INDICATED FOR REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) IN PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF    <= 35%) AND QRS DURATION >= 120 MS.
P010012|S017|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|NIK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2003|02/06/2004|||APPR|APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE AND CLINICAL STUDY SECTION LABELING.  THE DEVICES ARE INDICATED FOR:  FOR ICDS (VENTAK PRX, MINI, VITALITY, VENTAK AV AND PRIZM): GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  FOR VITALITY AVT:GUIDANT VITALITY AVT IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THIS DEVICE IS ALSO INTENDED TO PROVIDE ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT IN PATIENTS WHO HAVE OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.FOR CRT-DS (CONTAK CD AND RENEWAL):GUIDANT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  GUIDANT CRT-DS ARE ALSO INDICATED FOR REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) IN PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF    <= 35%) AND QRS DURATION >= 120 MS.
P930039|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSUREFIX NOVUS MODEL 4076 LEAD|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2003|02/09/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 4076 LEAD.
P930031|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|11/17/2003|12/11/2003|||APPR|APPROVAL FOR THE ADDITION OF TWO MANUFACTURING FACILITIES LOCATED AT BOSTON SCIENTIFIC CORP., QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, MAASTRICHT-AIRPORT, THE NETHERLANDS.  THESE FACILITIES WILL PERFORM PACKAGING AND LABELING OPERATIONS FOR THE WALLSTENT ENDOPROSTHESIS WITH THE UNISTEP PLUS DELIVERY SYSTEM.
P980033|S008|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2003|12/11/2003|||APPR|APPROVAL FOR THE ADDITION OF TWO MANUFACTURING FACILITIES LOCATED AT BOSTON SCIENTIFIC CORP., QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, MAASTRICHT-AIRPORT, THE NETHERLANDS.  THESE FACILITIES WILL PERFORM PACKAGING AND LABELING OPERATIONS FOR THE WALLSTENT ENDOPROSTHESIS WITH THE UNISTEP PLUS DELIVERY SYSTEM.
P940019|S016|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALL STENT ILIAC ENDOPROSTHESIS|MAF|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|11/17/2003|12/11/2003|||APPR|APPROVAL FOR THE ADDITION OF TWO MANUFACTURING FACILITIES LOCATED AT BOSTON SCIENTIFIC CORP., QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, MAASTRICHT-AIRPORT, THE NETHERLANDS.  THESE FACILITIES WILL PERFORM PACKAGING AND LABELING OPERATIONS FOR THE WALLSTENT ENDOPROSTHESIS WITH THE UNISTEP PLUS DELIVERY SYSTEM.
P960007|S018|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE|MGR|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2003|12/15/2003|||APPR|APPROVAL FOR THE ADDITION OF A DIRECT CULTURE-BASED 28-DAY PROCEDURE FOR MYCOPLASMA DETECTION BEFORE TRANCYTE MARKETING RELEASE.
P000036|S003|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL REPLACEMENT|MGR|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2003|12/15/2003|||APPR|APPROVAL FOR THE ADDITION OF A DIRECT CULTURE-BASED 28-DAY PROCEDURE FOR MYCOPLASMA DETECTION BEFORE DERMAGRAFT PRODUCT RELEASE.
P810031|S025|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON SODIUM HYALURONATE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2003|12/12/2003|||OK30|INSTALLATION OF A NEW AUTOCLAVE (HE-AC006) FOR THE HEALON SODIUM HYALURONATE.
P000052|S022|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS|MOU|CV|30-Day Notice||N|11/18/2003|12/18/2003|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR GUIDANT'S P-32 SOURCE WIRE BY USING AN ALTERNATE NEEDLE COATING PROCESS AND MATERIAL.
P970021|S010|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|CATHETER, BALLOON, TRANSCERVICAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MKN|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2003|12/02/2003|||APPR|APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS CORPORATION, ISOMEDIX SERVICES, EL PASO, TEXAS.
P990075|S014|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS|FWM|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/20/2003|01/16/2004|||APPR|APPROVAL FOR REVISED LABELING THAT REFLECTS 7-YEAR POST-APPROVAL STUDY DATA.
P960040|S037|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTTAK AV/PRIZM/PRIZM2,VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2003|12/19/2003|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FROM THE USE OF BIOLOGICAL INDICATORS TO PARAMETRIC RELEASE.
P910077|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI III,MINI IV|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2003|12/19/2003|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FROM THE USE OF BIOLOGICAL INDICATORS TO PARAMETRIC RELEASE.
P940031|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN, DISCOVERY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2003|12/19/2003|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FROM THE USE OF BIOLOGICAL INDICATORS TO PARAMETRIC RELEASE.
P010012|S018|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD/CD2, RENEWAL|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2003|12/19/2003|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FROM THE USE OF BIOLOGICAL INDICATORS TO PARAMETRIC RELEASE.
P930014|S013|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IOL MODEL SN60WF|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2003|12/24/2003|||APPR|APPROVAL FOR MODEL SN60WF.
P000043|S008|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2003|12/22/2003|||APPR|APPROVAL FOR THERMATRX, INC., NORTHBROOK, ILLINOIS AS AN ALTERNATE MANUFACTURING SITE FOR THE TEMPERATURE SENSOR AND TEMPERATURE REFERENCE PROBE.
P890055|S017|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN MODEL 3000 SERIES CONSTANT FLOW IMPLANTABLE PUMP|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2003|08/18/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CODMAN & SHURTLEFF, INC., RAYNHAM, MASSACHUSETTS.
P020036|S002|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2003|03/19/2004|||APPR|APPROVAL FOR THE FOLLOWING CHANGE TO THE DELIVER SYSTEM OF THE S.M.A.R.T. CONTROL NITINOL STENT SYSTEM: 1) THE WIRE LUMEN OF THE DELIVERY SYSTEM  WILL BE FABRICATED FROM DIFFERENT MATERIALS. 2) THE NEW WIRE LUMEN INNER DIAMETER SPECIFICATION HAS BEEN INCREASED. 3) THE PROXIMAL LAND SECTION OF THE DISTAL TIP HAS BEEN INCREASED. 4) THE INNER DIAMETER SPECIFICATION OF THE DISTAL TIP HAS BEEN INCREASE.
P980037|S007|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/26/2003|05/05/2004|||APPR|APPROVAL FOR THE XMI RAPID EXCHANGE (XMI-RX) CATHETER, A MODIFICATION OF THE XMI-OTW CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME POSSIS ANGIOJET XMI RAPID EXCHANGE RHEOLYTIC THROMBECTOMY SYSTEM, AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SAPHENOUS VEIN GRAFT LESIONS IN VESSELS >=2.0 MM IN DIAMETER PRIOR TO BALLOON ANGIOPLASTY OR STENT PLACEMENT.
P960040|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM MODELS 1850 AND 1851|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/26/2003|12/24/2003|||APPR|APPROVAL FOR LABELING CHANGES TO UPDATE BATTERY LONGEVITY INFORMATION.
P930027|S006|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA|LTJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2003|12/31/2003|||APPR|APPROVAL FOR THE INTRODUCTION OF THE IMMULITE 2500 PSA AND IMMUITE 2500 THIRD GENERATION PSA TESTS FOR USE ON THE IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2500 PSA AND IMMULITE 2500 THIRD GENERATION PSA ASSAYS FOR THE FOLLOWING INDICATION:  "THE IMMULITE 2500 PSA AND IMMUITE 2500 THIRD GENERATION PSA ASSAYS ARE FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2500 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER.  EACH ASSAY IS FURTHER INDICATED AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS."
P930016|S017|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2003|12/14/2004|05M-0055|02/09/2005|APPR|APPROVAL FOR THE STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM.  THE DEVICE USES A 6.00 MM OPTICAL ZONE, A 9.00 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AN D HYPEROPIC ASTIGMATISM UP TO 3.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND 2.00 D; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 1.0 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.
P910077|S043|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI I, II,III|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/26/2003|12/24/2003|||APPR|APPROVAL FOR LABELING CHANGES TO UPDATE BATTERY LONGEVITY INFORMATION.
P010012|S019|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD 2 MODEL H115|NIK|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/26/2003|12/24/2003|||APPR|APPROVAL FOR LABELING CHANGES TO UPDATE BATTERY LONGEVITY INFORMATION.
P970018|S007|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/2003|05/28/2004|||APPR|APPROVAL FOR MODIFIED LABELING OF THE PREPSTAIN SYSTEM FOR USE WITH AN ALTERNATE SPECIMEN COLLECTION DEVICE.
P980041|S004|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER|LOK|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2003|01/20/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BECKMAN COULTER, INC., CHASKA, MINNESOTA.
P880086|S098|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/02/2003|01/30/2004|||APPR|APPROVAL TO MODIFY THE HEADER DESIGN OF A CURRENTLY MARKETED DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERITY ADX XL VDR MODEL 5456I AND IS INDICATED AS FOLLOWS:  THE VERITY ADX XL VDR MODEL 5456I IS INDICATED FOR USE ONLY WITH AV PLUS MODEL 1328C OR 1358C SINGLE-PASS IN-LINE QUADRIPOLAR LEADS (THE VERITY ADX XL VDR PACING SYSTEM).  THE VERITY ADX XL VDR PACING SYSTEM IS INTENDED TO PROVIDE VDD OR VDDR PACING FOR PATIENTS WITH A HEALTHY SINUS NODE AND AV CONDUCTION ABNORMALITIES.  THESE MODES ARE INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT.  THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN:  A) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT, AND  B) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED.  ADDITIONAL INDICATIONS INCLUDE NORMAL SINUS RHYTHM AND NORMAL AV CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING.
P830045|S090|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/02/2003|01/30/2004|||APPR|APPROVAL TO MODIFY THE HEADER DESIGN OF A CURRENTLY MARKETED DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERITY ADX XL VDR MODEL 5456I AND IS INDICATED AS FOLLOWS:  THE VERITY ADX XL VDR MODEL 5456I IS INDICATED FOR USE ONLY WITH AV PLUS MODEL 1328C OR 1358C SINGLE-PASS IN-LINE QUADRIPOLAR LEADS (THE VERITY ADX XL VDR PACING SYSTEM).  THE VERITY ADX XL VDR PACING SYSTEM IS INTENDED TO PROVIDE VDD OR VDDR PACING FOR PATIENTS WITH A HEALTHY SINUS NODE AND AV CONDUCTION ABNORMALITIES.  THESE MODES ARE INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES AND ADEQUATE INTRACAVITARY ATRIAL COMPLEXES ARE PRESENT.  THIS INCLUDES THE PRESENCE OF COMPLETE AV BLOCK WHEN:  A) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT, AND  B) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED.  ADDITIONAL INDICATIONS INCLUDE NORMAL SINUS RHYTHM AND NORMAL AV CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING.
P010049|S010|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/2003|05/25/2004|||APPR|APPROVAL TO MODIFY THE DESIGN OF THE QUICKSEAL ARTERIAL CLOSURE SYSTEM TO ALLOW THE DELIVERY OF Q-FOAM HEMOSTATIC SPONGE THROUGH AN INTRODUCER DELIVERY SHEATH AND ELIMINATE THE DEPTH MARKET COMPONENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKSEAL SURESHOT AND IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTATIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS.  THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND REDUCES TIME TO ACTUAL HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES.
P890003|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|2490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2003|12/29/2003|||APPR|APPROVAL FOR THE MODEL 2490E CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH THE MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II MARQUIS, MODEL 7289 DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P980016|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2003|12/29/2003|||APPR|APPROVAL FOR THE MODEL 2490E CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH THE MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II MARQUIS, MODEL 7289 DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P010031|S011|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2003|12/29/2003|||APPR|APPROVAL FOR THE MODEL 2490E CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH THE MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II MARQUIS, MODEL 7289 DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P910073|S043|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE  G/SG LEAD MODELS 0180-0187|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/04/2003|03/02/2004|||APPR|APPROVAL FOR ADDITION OF AN EPTFE COATING TO THE SHOCK COILS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK RELIANCE G/SG LEAD MODELS AND IS INDICATED FOR PROVIDING PACING AND RATE-SENSING AND TO DELIVER CARDIOVERSION AND DEFIBRILLATION SHOCKS FOR ICD AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS.
P900056|S079|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2003|01/08/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE FOR THE CONSOLE AND ASSOCIATED ACCESSORIES LOCATED AT PLEXUS EA SEATTLE, BOTHELL, WASHINGTON.
P010033|S006|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON -TB GOLD|NCD|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/2003|12/02/2004|||APPR|APPROVAL FOR THE USE OF SYNTHETIC PEPTIDE ANTIGENS ESAT-6 AND CFP-10 AND REMOVAL OF THE TUBERCULIN PPD AND M. AVIUM PPD ANTIGENS USED IN THE QUANTIFERON - TB.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING PEPTIDE COCKTAILS SIMULATING ESAT-6 AND CFP-10 PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD.  DETECTION OF INTERFERON-Y BY ELISA IS USED TO IDENTIFY IN VITRO RESPONSES TO ESAT-6 AND CFP-10 THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION.  THE DEVICE APPROVAL IS FOR USE OF AN 8-POINT CALIBRATION CURVE WITH MANUAL CALCULATIONS.
P010018|S006|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CK SYSTEM|MWD|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2003|01/15/2004|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE COMPONENT AT STELLARTECH RESEARCH CORP., SUNNYVALE, CALIFORNIA.
P960004|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FINELINE II PACING LEADS|DTB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2003|12/19/2003|||APPR|APPROVAL FOR THE ADDITION OF A SPECIFICATION FOR THE CONDUCTOR-TO-TERMINAL PIN WELD STRENGTH.
P950029|S019|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/04/2003|02/13/2004|||APPR|APPROVAL FOR THE FIRMWARE MODIFICATIONS (VERSION GXD T3) OF THE SYMPHONY AND ELA RHAPSODY PACEMAKERS.
P970003|S052|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|12/23/2003|||OK30|CHANGE IN THE LOCATION OF THE PERFORMANCE OF THE ENVIRONMENTAL TESTING.
P980033|S009|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P990054|S007|Boston Scientific Corp.|2710 ORCHARD PKWY.||SAN JOSE|CA|95113||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEMS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P930031|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLENSTENT TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P940019|S017|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT LILIAC ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P020009|S014|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P950020|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P970061|S020|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|RADIUS CORONARY STENT WITH DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P860019|S199|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA/PERFUSION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P020025|S003|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP RF ABLATION SYSTEMS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P880027|S063|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P880065|S009|Boston Scientific Corp.|One Scimed Place||Maple Grove|MN|55311||PULSE-GENERATOR, PROGRAM MODULE|AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER|LOT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P900056|S080|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM WIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P920047|S022|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEMS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P980003|S011|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABALATION SYSTEMS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|01/07/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION.
P020014|S006|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/08/2003|07/22/2004|||APPR|APPROVAL FOR MODIFICATION OF A WARNING STATEMENT IN THE ESSURE PHYSICIAN LABELING REGARDING THERMAL ENDOMETRIAL ABLATION IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE.
P000032|S004|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CYROABLATION THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2003|03/31/2004|||APPR|APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT AMERICAN MEDICAL SYSTEMS, INC., MINNETONKA, MINNESOTA.
P960058|S032|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/09/2003|12/16/2003|||APPR|APPROVAL FOR AN OPTIONAL ACCESSORY ITEM THAT CAN BE USED WITH THE PLATINUM HEADPIECE AND AURIA HEADPIECE.  THIS ITEM, NAMED HEADPIECE SPACER, IS A PASSIVE PIECE OF ELASTOMER INTENDED TO BE PLACED BETWEEN THE HEADPIECE INNER SURFACE AND THE PATIENT'S SCALP.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17 YEARS, 11-MONTHS OF AGE).
P930029|S021|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/10/2003|02/05/2004|||APPR|APPROVAL FOR A LINE EXTENSION TO THE COMMERCIALLY AVAILABLE RF ENHANCR CATHETER LINE WITH THE CHANGES LIMITED TO A NEW HANDLE DESIGN AND ASSOCIATED PACKAGING CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS AND IS INDICATED FOR USE WITH THE MEDTRONIC RF POWER GENERATOR TO DELIVER RF ENERGY FOR INTRACARDIAC ABLATION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA FOR THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA AND FOR CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
P980050|S015|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/12/2003|04/12/2004|||APPR|APPROVAL FOR THE MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974.  THE DEVICE IS INDICATED AS FOLLOWS: THE MODEL 7276 GEM III AT WITH APP IS INDICATED FOR USE IN ICD PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  IN ADDITION, THE DEVICE IS INTENDED TO PROVIDE PACING, CARDIOVERSION, AND DEFIBRILLATION FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC, DRUG-REFRACTORY ATRIAL FIBRILLATION, AND/OR LIFE THREATENING VENTRICULAR TACHYARRHYTHMIAS.  ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP) AND POST MODE SWITCH OVERDRIVE (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND ONE OR MORE OF THE ABOVE ICD INDICATIONS.  NOTES: THE USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS.  THE EFFECTIVENESS OF HIGH FREQUENCY BURST PACING  (ATRIAL-50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.8%, IN THE VT/AT PATIENT POPULATION STUDIED.  THE EFFECTIVENESS OF HIGH FREQUENCY BURST PACING (ATRIAL-50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 11.7%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 18.2%, IN THE AF-ONLY PATIENT POPULATION STUDIED.
P010007|S002|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|IMMULITE 2500 AFP, MODEL L5KAP|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/12/2003|12/31/2003|||APPR|APPROVAL FOR USE OF THE IMMULITE 2000 AFT ON THE IMMULITE 2500 AUTOMATED ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2500 AFP AND IS INDICATED:  "FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2500 ANALYZERS FOR THE QUANTITATIVE MEASUREMENT OF ALPHA-FETOPROTEIN (AFP) IN EITHER OF TWO CONTEXTS: (1) SERIAL MEASUREMENTS IN HUMAN SERUM TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER; OR (2) MEASUREMENTS IN MATERNAL SERUM AND AMNIOTIC FLUID DURING GESTATIONAL WEEKS 15 THROUGH 20, USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY, TO AID IN DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS."
P900023|S039|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/2003|12/23/2003|||APPR|APPROVAL FOR AN ADDITIONAL LABEL IN THE FORM OF A PACKAGING STICKER STATING, "ONLY USE THREADED RESTRAINTS WITH THE AB5000 VENTRICLE.  USE OF NON-THREADED CANNULA RESTRAINTS MAY RESULT IN: 1) CANNULAE BECOMING DISCONNECTED FROM THE VENTRICLE, AND  2) THROMBUS FORMATION."
P950008|S006|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2003|12/22/2003|||APPR|APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR THE FINISHED PRODUCT VISCOSITY RANGE, I.E., FROM THE RANGE OF 900 TO 1200 CS TO THE RANG OF 900 TO 1250 CS.
P930016|S018|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/2003|06/07/2004|||APPR|APPROVAL FOR SOFTWARE UPGRADE: WAVESCAN SOFTWARE VERSION 3.5 CHANGES FROM CURRENTLY APPROVED VERSION 3.07 (UNDER P930016/S016) FOR VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM FOR WAVEFRONT-GUIDED LASIK TREATMENTS OF MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D.
P000018|S040|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH 3.5F SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2003|06/10/2004|||APPR|APPROVAL FOR THE BETA-RAIL 3.5F DELIVERY CATHETER WITH DISTAL IMPROVEMENTS, AND A CHANGE IN THE PROCEDURE ACCESSORY PACK.
P020026|S008|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2003|06/14/2004|||APPR|APPROVAL FOR A MODIFICATION TO THE RESIDUAL SOLVENT TEST METHOD FOR THE CYPHER SIROLIMUS-ELUTING CORONARY STENT.
P000021|S003|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION TPSA FLEX REAGENT CARTRIDGE|LTJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2003|12/30/2003|||APPR|APPROVAL OF THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION RXL MAX ANALYZER.  THE DEVICE WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR:  THE TPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM AND PLASMA:  1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.  2) AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
P030039|S001|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2003|01/12/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAXTER HEALTHCARE CORPORATION, BAXTER BIOSCIENCES, DIVISION, FREMONT, CALIFORNIA.
P020025|S004|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP CARDIAC ABLATION SYSTEM|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2003|06/09/2004|||APPR|APPROVAL FOR A CHANGE IN DESIGN OF THE EPT-1000 XP CARDIAC ABLATION CONTROLLER.  THE CHANGE IN DESIGN INCORPORATES THE ORIGINALLY APPROVED EPT-1000 XP CONTROLLER WITH TRACK WHILE ABLATE (TWA) TECHNOLOGY TO VISUALIZE CATHETER NAVIGATION DURING RF ENERGY DELIVERY USING THE REAL TIME POSITION MANAGEMENT (RPM) SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRACK WHILE ABLATE (TWA) EPT-1000 XP CARDIAC ABLATION SYSTEM.  THE TWA EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.
P000029|S005|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2003|01/13/2004|||OK30|CHANGE IN THE VISUAL INSPECTION PROCESS TO EMPLOY A NEW SEMI-AUTOMATIC INSPECTION MACHINE.
P010025|S004|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2003|03/02/2004|||APPR|APPROVAL FOR SELENIA FFDM SYSTEM FOR USE IN A MOBILE ENVIRONMENT AND QC MANUAL CHANGES.
P920015|S030|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6948 AND 6930 LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2003|06/08/2004|||APPR|APPROVAL FOR THE ADDITION OF A POLYURETHANE OVERLAY.
N18033|S039|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/22/2003|02/04/2004|||APPR|APPROVAL FOR AN ALTERNATIVE BINDING POLYMER TO THE ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER.
P960040|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY 2 AICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2) AND QUICK PROFILE|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/22/2003|03/08/2004|||APPR|APPROVAL FOR THE VITALITY 2 ICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2), AND QUICK PROFILES DISK (MODEL 2828 VERSION 1.0).  THE DEVICE IS INDICATED FOR USE IN THE FOLLOWING: GUIDANT ICDS ARE INTENDED TO PROVIDE THERAPY FOR THE AUTOMATED TREATMENT OFLIFE-THREATENING VENTRICULAR ARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE:  1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR  2) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION OF <= 30%.
P000025|S012|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH MED-EL CI.STUDIO+ RELEASE VERSION 2.0 SOFTWARE|MCM|EN|Normal 180 Day Track||N|12/16/2003|05/14/2004|||APPR|MED-EL CI.STUDIO+ RELEASE VERSION 2.0 SOFTWARE FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
P990071|S005|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR|DRF|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2003|06/06/2005|||APPR|APPROVAL FOR MANUAL OPERATION OF THE COOLFLOW IRRIGATION PUMP WITH THE BIOSENSE WEBSTER THERMOCOOL CATHETERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLFLOW IRRIGATION PUMP.  THE COOLFLOW IRRIGATION PUMP AND TUBING SET IS A PERISTALTIC IRRIGATION PUMP DESIGNED FOR THE DELIVERY OF SALINE SOLUTION WHEN USED IN CONJUNCTION WITH THE STOCKERT 70 RF GENERATOR AND THE THERMOCOOL IRRIGATION CATHETERS.
P020018|S003|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2003|04/15/2004|||APPR|APPROVAL TO INCREASE THE STENT SPACING (FROM 0-3 MM TO 5 += 1MM) ON THE MAIN BODY AND THE MAIN BODY EXTENSION COMPONENTS OF THE ZENITH AAA ENDOVASCULAR GRAFT.
P980043|S004|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROTHESIS MODELS T505, T510|DYE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2003|01/23/2004|||APPR|APPROVAL FOR A MODIFICATION TO THE INSTRUCTIONS FOR USE.
P890023|S014|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|HYDROGENICS 60 (OCUFILCON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track No User Fee|Express GMP Supplement|N|12/22/2003|01/14/2004|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT OCULAR SCIENCES PUERTO RICO IN JUANA DIAZ, PUERTO RICO AND SANTA ISABEL, PUERTO RICO.
P990064|S009|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS MODELS 305, 310|DYE|CV|Special (Immediate Track)||N|12/22/2003|01/23/2004|||APPR|APPROVAL FOR A MODIFICATION TO THE INSTRUCTIONS FOR USE.
P020023|S001|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/29/2003|02/04/2004|||APPR|APPROVAL FOR INCREASING THE EXPIRATION DATING FROM RESTYLANE FORM 12 MONTHS TO 24 MONTHS.
P950002|S013|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|VISTA LORDOTIC INTERBODY FUSION CAGE|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2003|01/29/2004|||APPR|APPROVAL FOR THE VISTA LORDOTIC DEVICE TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VISTA LORDOTIC AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE OR TWO CONTINUOUS LEVELS FROM L4-L5 AND/OR L5-S1.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S).  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.  THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.  VISTA LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH.
P950032|S037|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APILGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2003|01/23/2004|||OK30|TWO MANUFACTURING CHANGES INVOLVING THE SEED POOL PRODUCTION PROCESS.
P020045|S003|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/29/2003|07/19/2004|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER Y-BLOCK.
P790017|S081|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2003|06/23/2004|||APPR|APPROVAL FOR MINOR DESIGN, PACKAGING AND LABELING CHANGES TO THE STORMER OTW BALLON DILATATION CATHETER INCLUDING THE ADDITION OF 6 MM AND 12 MM BALLOON LENGTHS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPRINTER OTW BALLOON DILATATION CATHETER AND IS INDICATED AS FOLLOWS:  FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE SPRINTER OTW BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM - 4.0 MM) IS ALSO INDICATED FOR POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.  NOTE: BENCH TESTING WAS CONDUCTED WITH THE SPRINTER OTW BALLOON DILATATION CATHETER AND MARKETED BALLOON EXPANDABLE STENTS.  CONSIDERATION SHOULD BE TAKEN WHEN THIS DEVICE IS USED WITH DIFFERENT MANUFACTURERS' STENTS DUE TO DIFFERENCES IN STENT DESIGN.
P900033|S011|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|DERMAL REGENERATION TEMPLATE|MDD|SU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/02/2004|04/23/2004|||APPR|APPROVAL FOR TERMINAL STERILIZATION OF THE DERMAL REGENERATION TEMPLATE BY E-BEAN STERILIZATION.
P970004|S027|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/02/2004|01/28/2004|||APPR|APPROVAL FOR A CHANGE IN THE TECHNICAL MANUAL TO PROVIDE PHYSICIANS WITH INSTRUCTIONS ON REMOVAL OF THE TINED LEAD.
P870072|S027|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/06/2004|08/03/2004|||APPR|APPROVAL FOR THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) AS AN ALTERNATE VAD BLOOD PUMP FOR USE IN THE APPROVED THORATEC VENTRICULAR ASSIST DEVICE SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE AND IS INDICATED FOR USE IN BRIDGE TO TRANSPLANT PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA: CANDIDATE FOR CARDIAC TRANSPLANTATION, IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, DEPENDENCE ON, OR INCOMPLETE RESPONSE TO, CONTINUED VASOPRESSOR SUPPORT.  IT IS ALSO INDICATED FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS.  IN ADDITION, THE IVAD IS DESIGNED TO BE COMPATIBLE WITH BOTH THE DUAL DRIVER CONSOLE AND TLC-II PORTABLE VAD DRIVER.
P920014|S023|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/09/2004|07/08/2004|||APPR|APPROVAL FOR USE OF THE POWERSONIC SEALED LEAD ACID BATTERY (MODEL PS-1223) AS A REPLACEMENT FOR THE NO LONGER MANUFACTURED PANASONIC SEALED LEAD ACID BATTERY (MODEL LC-SA122R3EU) AS A SOURCE OF BATTERY POWER TO DRIVE THE HEARTMATE VE AND ZVE LEFT VENTRICULAR ASSIST SYSTEMS.
P000052|S023|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/09/2004|03/16/2004|||APPR|APPROVAL TO IMPLEMENT A NEW SOFTWARE REVISION, VERSION 63-033/N.  THE SOFTWARE WAS REVISED TO INCREASE THE DISTAL STOP FORCE OF THE ACTIVE SOURCE WIRE.
P960004|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FINELINE/ THINLINE|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P960006|S009|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P960040|S040|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/ PRIZM/PRIZM2/ VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P830060|S053|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P010012|S021|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD/CD2/RENEWAL/EASYTRAK|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P910073|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK/ ENDURANCE/ RELIANCE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P910077|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX/ MINI III/ MINI IV|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P940008|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P940031|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN DISCOVERY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P950001|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2004|02/10/2004|||OK30|CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
P010033|S007|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON - TB|NCD|MI|30-Day Notice||N|01/14/2004|02/10/2004|||OK30|CHANGE TO THE MANUFACTURING PROCESS OF THE QUANTIFERON-TB TO ALLOW THE USE OF K-BLUE MAX SUBSTRATE AS AN ALTERNATIVE SUBSTRATE REAGENT TO INCREASE THE SHELF LIFE OF THE KIT TO 3 YEARS.
P980003|S012|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2004|02/09/2004|||OK30|FOUR MANUFACTURING CHANGES:  1) CHANGE TO COOLING LUMEN EXTRUSION;  2) CHANGE TO FLUX CLEANING PROCESS;  3) CHANGE FROM 1X TO 2X KEVLAR WRAP; AND  4) CHANGE FROM MOLDED TO MACHINED DISTAL RING ELECTRODE GROOVES.
P860004|S058|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/2004|04/26/2004|||APPR|APPROVAL FOR THE MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT THAT IS INTENDED TO PROVIDE ACCESS TO THE EPIDURAL OR INTRATHECAL SPACE FOR UP TO 4 DAYS.
P010012|S022|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EASYTRAK IS-1 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513|NIK|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/2004|02/12/2004|||APPR|APPROVAL TO MODIFY LEAD MANUALS.
P960040|S041|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM AICD, VENTAK PRIZM HE AICE, VENTAK PRIZM 2 AICD AND VITALITY DS/EL AICD SYSTEMS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2004|03/09/2004|||APPR|APPROVAL FOR THE FIRMWARE MODIFICATIONS OF THE FOLLOWING AICD SYSTEMS:  VENTAK PRIZM AICD SYSTEM (MODELS 1850, 1851, 1855, 1856) FIRMWARE VERSION 1.2 PATCH H, VENTAK PRIZM HE AICD SYSTEM (MODELS 1852, 1853, 1857, 1858) FIRMWARE VERSION 1.2 PATCH H, VENTAK PRIZM 2 AICD SYSTEM (MODELS 1860, 1861) FIRMWARE VERSION 1.4 PATCH C,  VITALITY DS/EL AICD SYSTEM (MODELS T125, T127, T135) FIRMWARE VERSION  1.0 PATCH B, CONTAK CD 2 (MODELS H115, H119) FIRMWARE VERSION 1.2 PATCH H, AND THE APPLICATION SOFTWARE MODEL 2844 VERSION 3.7.
P010012|S023|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD 2 (MODELS H115, H119) AND APPLICATION SOFTWARE MODEL 2844|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2004|03/09/2004|||APPR|APPROVAL FOR THE FIRMWARE MODIFICATIONS OF THE FOLLOWING AICD SYSTEMS:  VENTAK PRIZM AICD SYSTEM (MODELS 1850, 1851, 1855, 1856) FIRMWARE VERSION 1.2 PATCH H, VENTAK PRIZM HE AICD SYSTEM (MODELS 1852, 1853, 1857, 1858) FIRMWARE VERSION 1.2 PATCH H, VENTAK PRIZM 2 AICD SYSTEM (MODELS 1860, 1861) FIRMWARE VERSION 1.4 PATCH C,  VITALITY DS/EL AICD SYSTEM (MODELS T125, T127, T135) FIRMWARE VERSION  1.0 PATCH B, CONTAK CD 2 (MODELS H115, H119) FIRMWARE VERSION 1.2 PATCH H, AND THE APPLICATION SOFTWARE MODEL 2844 VERSION 3.7.
P000033|S001|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|INTRACOIL PERIPHERAL STENT|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2004|02/13/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE WIRE POLISHING VENDOR FOR THE NITINOL WIRE POLISHING PROCESS.
P860008|S017|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES|LPA|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|01/16/2004|02/03/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE AT CARDIOCOMMAND, INC., TAMPA, FLORIDA.
P840002|S010|CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES|LPA|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|01/16/2004|02/03/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE AT CARDIOCOMMAND, INC., TAMPA, FLORIDA.
P000032|S005|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/2004|11/09/2004|||APPR|APPROVAL FOR A REVISED USER'S MANUAL AND PACKAGE INSERT WHICH REFLECTS THE RESULTS OF THE LONG TERM FOLLOW-UP OF STUDY SUBJECTS AND A QUICK REFERENCE GUIDE.
P020023|S002|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2004|02/13/2004|||OK30|TWO MANUFACTURING CHANGES INVOLVING THE RESTYLANE PRODUCTION PROCESS.
P020026|S010|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/2004|04/15/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM (CYPHER STENT) INSTRUCTIONS FOR USE (IFU).
P910066|S019|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/20/2004|09/10/2004|||APPR|APPROVAL FOR 1) CHANGE IN THE LABELING TO REFLECT THE NEW COMPANY OWNERSHIP FROM ORTHOLOGIC TO DJ ORTHOPEDICS/ REGENTEK; 2) ADDITION OF A PRODUCT SPECIFICATIONS SECTION TO ALL MANUALS TO COMPLY WITH CANADIAN STANDARDS ASSOCIATION. (APPLIES TO OL SERIES AND SPINALOGIC MANUALS); 3) ADDITION OF REFERENCE SECTION (APPLIES TO SPINALOGIC MANUALS ONLY); AND 4) IN RISK AND BENEFITS SECTION OF THE SPINALOGIC PATIENT MANUAL, REVISION THE STATEMENT "20% GREATER CHANCE OF BACK SURGERY HEALING" TO "THE BENEFIT OF THE SPINALOGIC IS THAT YOU HAVE A GREATER CHANCE OF YOUR BACK SURGERY HEALING IF YOU USE THE DEVICE EVERY DAY THAN IF YOU DON NOT USE IT."
P960040|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK VITALITY AVT AICD SYSTEM (MODEL A135)|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2004|03/19/2004|||APPR|APPROVAL FOR THE SYSTEM GUIDE LABELING REINSERT (CHANGE TACHY MODE WITH MAGNET FEATURE).
P950002|S014|Zimmer Spine, Inc|7375 Bush Lake Road||Minneapolis|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK VISTA INTERBODY FUSION CAGE|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/21/2004|07/01/2004|||APPR|APPROVAL TO ADD THE FOLLOWING SIZES TO THE BAK VISTA DEVICE: 9X24 MM, 11X24 MM, 13X24 MM, 15X24 MM, 17X24 MM, 19X24 MM.  THE BAK VISTA INTERBODY FUSION DEVICE, WHICH IS MANUFACTURED FROM 65% PEEK OPTIMA AND 35% TOHO BESFIGHT C6-UH CARBON FIBER, TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME BAK VISTA INTERBODY FUSION DEVICE AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L2-S1 LEVELS.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVELS.  BAK DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR POSTERIOR APPROACH.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.  THESE PATIENTS WOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.
P010059|S001|MORCHER GMBH|KAPUZINERWEG 12||STUTTGART, WURTTEMBERG-BADEN||D-703|7037|Ring, endocapsular|ALCON REFORM CAPSULAR TENSION RING|MRJ|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/2004|03/15/2004|||APPR|APPROVAL FOR A PRIVATE LABEL DISTRIBUTOR AGREEMENT WITH ALCON LABORATORIES, INC., FORT WORTH, TEXAS.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ALCON REFORM CAPSULAR TENSION RINGS (MODELS ACTR10, ACTR11, AND ACTR12).
P010030|S005|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST (WCD 3000S) WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/21/2004|05/03/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE LIFEVEST WCD 3000 DEVICE TO BETTER FACILITATE SHORT-TERM USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3000S AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.  THE LIFEVEST WCD 3000S SYSTEM IS INTENDED FOR SHORT-TERM USE IN A MEDICALLY SUPERVISED ENVIRONMENT.  THE DEVICE IS NOT INTENDED TO BE WORN HOME.
P940034|S015|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST|MWA|MI|30-Day Notice||N|01/22/2004|02/10/2004|||OK30|CHANGE TO QC SPECIFICATION FOR THE RELEASE OF THE AMPLIFICATION REAGENT.
P980016|S040|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ONYX SYSTEM, DEVICE MODEL 7290CX AND SOFTWARE MODEL 9999|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2004|03/08/2004|||APPR|APPROVAL FOR DEVICE MODIFICATIONS TO THE GEM II/III VR SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC ONYX SYSTEM, DEVICE MODEL 7290CX AND SOFTWARE MODEL 9999 AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
P000025|S013|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2004|02/25/2004|||OK30|ADDITION OF AN ALTERNATIVE SUPPLIER FOR THE ELECTRODE WIRE USED IN THE MED-EL COMBI 40+ COCHLEAR IMPLANT.
P990004|S005|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2004|07/29/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM.
P810046|S215|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||CATHETER, FLOW DIRECTED|RX CHASSIS 3 CORONARY DILATATION CATHETER|DYG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/2004|07/16/2004|||APPR|APPROVAL FOR THE RX CHASSIS 3 CORONARY DILATION CATHETER.  THE DEVICE, AS MODIFIED, IS INDICATED FOR 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND 2) BALLOON DILATATION OF A CORONARY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.
P830055|S088|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/26/2004|07/01/2004|||APPR|APPROVAL FOR THE ADDITION OF CEMENTED POSTERIOR STABILIZED (PS) FEMORAL COMPONENTS AND TIBIAL BEARING COMPONENTS TO THE EXISTING LCS TOTAL KNEE SYSTEM.  THAT IS, THE ADDITION OF THE LCS COMPLETE M1 PS COMPONENTS (SIZES STANDARD, STANDARD+, AND LARGE).  THE LCS COMPLETE M1 PS CEMENTED FEMORAL COMPONENT COMBINES FEATURES OF THE PREVIOUSLY APPROVED LCS PS AND LCS COMPLETE FEMORAL COMPONENTS AND ALSO INCLUDES MODIFICATION TO THE GEOMETRY AND POSITION OF THE ANTERIOR AND POSTERIOR FEMORAL CAMS. ALONG WITH ASSOCIATED MODIFICATION TO THE LENGTH OF THE PATELLO-FEMORAL ARTICULATION.  THE LCS COMPLETE M1 PS TIBIAL INSERT COMPONENT COMBINES FEATURES OF THE PREVIOUSLY APPROVED LCS PS AND LCS COMPLETE RP TIBIAL BEARING COMPONENTS AND  IS MODIFIED TO ACCOMMODATE THE CHANGES IN ANTERIOR AND POSTERIOR FEMORAL CAM GEOMETRY.
P980035|S033|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC SIGMA MODELS SS106, SSR306, SC203, SDR203, SD303, SDR303, DR353 AND SVDD303|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2004|02/17/2004|||APPR|APPROVAL FOR MINOR MANUFACTURING MODIFICATIONS AND IMPROVEMENTS.
P000053|S002|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS SPHINCTER 800 URINARY CONTROL SYSTEM|EZY|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/15/2004|03/16/2004|||APPR|APPROVAL FOR REVISION OF THE LABELING TO DESCRIBE AN ALTERNATE SURGICAL APPROACH (I.E., TRANSVERSE SCROTAL IMPLANTATION).
P990046|S010|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2004|02/27/2004|||OK30|CHANGE IN THE GRINDING OPERATION USED DURING MANUFACTURING OF ORIFICES.
P900009|S018|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 2000+ AND EXOGEN 3000|LPQ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/29/2004|03/12/2004|||APPR|APPROVAL FOR TWO DESIGN AND COMPONENT CHANGES: 1) CHANGES TO EXOGEN 2000+ PRINTED CIRCUIT BOARD TO IMPLEMENT CORRECTIVE ACTION FOR FIELD FAILURE AND RETURNS.  THIS CORRECTIVE ACTION INVOLVES TWO DESIGN CHANGES: I) REPLACE 2 DIODES ON TE PRINTED CIRCUIT BOARD WITH LIGHT EMITTING DIODES. II) ADD A 1000 PF CAPACITOR TO REDUCE ELECTRICAL NOISE.  2) REPLACE BOTH EXOGEN 2000+ AND EXOGEN 3000 TRANSDUCER CABLES WITH A MORE COST EFFECTIVE MODEL.
P990043|S005|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-EBK PLUS ASSAY|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2004|02/12/2004|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT:  THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."
P020024|S002|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2004|09/16/2005|||OK30|ALTERNATE TRIMMING METHOD OF THE NITINOL WIRE BRAIDS.
P970003|S053|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2004|03/03/2004|||OK30|CHANGES IN THE MANUFACTURING PROCESS TO PROPOSE USING CYBERONICS, INC. AS AN ADDITIONAL IN-HOUSE FACILITY FOR BIOBURDEN TESTING ON PRODUCTS AND REDUCING THE FREQUENCY OF SAMPLING OF TUNNELING TOOLS AND ACCESSORY PACKS.
P000039|S007|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2004|09/16/2005|||OK30|ALTERNATE TRIMMING METHOD OF THE NITINOL WIRE BRAIDS.
P030005|S001|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|permanent pacemaker Electrode|CONTAK RENEWAL TR, MODELS H120, H125|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2004|03/03/2004|||OK30|CHANGE IN THE METHOD THAT IS USED TO RELEASE STERILIZED PRODUCT, FROM THE USE OF BIOLOGICAL INDICATORS TO PARAMETRIC RELEASE.
P960022|S004|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFTLENS66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2004|03/04/2004|||OK30|ADDITION OF AN AUTOMATED INSPECTION PROCESS FOR THE SOFTLENS66.
P980006|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS|LPM|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|01/06/2004|02/11/2004|||APPR|APPROVAL TO MODIFY THE POST-APPROVAL STUDY FOR THE DEVICE.
P030009|S001|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER MX2 CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2004|08/04/2004|||APPR|APPROVAL FOR ADDING THE MX2 CATHETER TO THIS PRODUCT LINE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DRIVER MX2 CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS WITH REFERENCE VESSEL DIAMETERS OF 3.0 - 4.0 MM AND <=30 MM IN LENGTH USING DIRECT STENTING OR PRE-DILATATION.  OUTCOME BEYOND 270 DAYS FROM THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P970003|S054|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2004|03/03/2004|||OK30|MANUFACTURING PROCESS CHANGE TO REDUCE THE MINIMUM VACUUM BAKE PROCESS TIME FOR THE CYBERONICS MODELS 102/102R PULSE GENERATORS.
P960058|S033|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2004|02/18/2004|||APPR|APPROVAL FOR A NEW AURIA (BEHIND-THE-EAR) ACCESSORY, CALLED THE AURIA T-COIL.  THE ACCESSORY PROVIDES AURIA USERS AN OPTIONAL INTERFACE FOR TELEPHONES AND INDUCTION LOOP-BASED ASSISTIVE LISTENING SYSTEM.
P010015|S012|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC LEFT VENTRICULAR PACING LEAD, ATTAIN BIPOLAR OTW MODEL 4194|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/2004|08/20/2004|||APPR|APPROVAL FOR MODIFICATION TO THE COIL AND INNER LUMEN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATTAIN BIPOLAR OTW MODEL 4194 AND IS INDICATED FOR USE AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.
P990041|S004|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-EBK PLUS ASSAY|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2004|02/20/2004|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT:  THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."
P890019|S009|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|DIASORIN ETI-AB-HAVK PLUS ASSAY|LOL|MI|Special (Immediate Track)||N|01/30/2004|02/20/2004|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT:  THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."
P930039|S018|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC MODEL 5076 LEAD|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2004|03/10/2004|||OK30|USE OF MED-2000 SILICONE ADHESIVE AS AN ALTERNATIVE FOR MED-1137 SILICONE ADHESIVE.
P980035|S034|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATIONS SOFTWARE|DXY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2004|08/25/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO.
P990086|S004|SANUWAVE, INC.|11680 GREAT OAKS WAY|SUITE 350|ALPHARETTA|GA|30022||Generator, shock-wave, for pain relief|HEALTHTRONICS OSSATRON|NBN|PM|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/2004|08/06/2004|||APPR|APPROVAL FOR INSERTION OF A TABLE OF ADVERSE EVENTS AND A BRIEF PARAGRAPH FOLLOWING THE POST-APPROVAL STUDY OF ESW TREATMENT OF PLANTAR FASCIITIS CONSTITUTING THE LABELING CHANGES IN THE OPERATING MANUAL.
P000029|S006|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2004|03/01/2004|||OK30|CHANGES IN BIOBURDEN TEST SITE FROM AN EXTERNAL LAB TO IN-HOUSE, AN IDENTITY TEST METHOD FOR A RAW MATERIAL, AND SPECIFICATION LIMITS FOR A RAW MATERIAL.
P020023|S003|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2004|03/03/2004|||OK30|CHANGES IN THE RESTYLANE RAW MATERIAL, SODIUM HYALURONATE.
P950037|S037|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|PHILOS DR-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2004|03/31/2004|||APPR|APPROVAL FOR THE ADDITION OF TWO CARDIO REPORT TRIGGERS FOR THE PHILOS DR-T PULSE GENERATOR AND FOR REVISIONS TO THE A-K00.1.U/5 PROGRAMMER SOFTWARE WHICH ARE NECESSARY IN ORDER TO UTILIZE THE MODIFIED PHILOS DR-T.
P000012|S003|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/13/2004|08/30/2004|||APPR|APPROVAL FOR THE COBAS AMPLIPREP/ COBAS AMPLICOR HCV TEST, V2.0 INSTRUMENT WHICH FULLY AUTOMATES THE SPECIMEN TESTING PORTION OF THE TEST.
P980049|S012|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALTO DR MODEL 614, ALTO VR MODEL 615, ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625|MRM|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/17/2004|03/15/2004|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE A MORE ACCURATE BATTERY LONGEVITY DATA.
P890003|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 2490D CARELINK MONITOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2004|03/08/2004|||APPR|APPROVAL FOR THE MODEL 2490D CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH ENPULSE AND KAPPA DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P980035|S035|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2004|03/08/2004|||APPR|APPROVAL FOR THE MODEL 2490D CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH ENPULSE AND KAPPA DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P890047|S016|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VICOSURGICAL DEVICE|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2004|03/05/2004|||APPR|APPROVAL TO MODIFY THE PH RELEASE AND STABILITY SPECIFICATION RANGES FOR PROVISC OPHTHALMIC VISCOSURGICAL DEVICE CONTAINED WITHIN THE DUOVISC VISCOELASTIC SYSTEM FROM PH 7.0-7.3 TO PH 7.0-7.4 FOR RELEASE AND PH 7.0-7.5 TO PH 6.8-7.5 FOR STABILITY.
P840064|S025|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DUOVISC VISCOELASTIC SYSTEM|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2004|03/05/2004|||APPR|APPROVAL TO MODIFY THE PH RELEASE AND STABILITY SPECIFICATION RANGES FOR PROVISC OPHTHALMIC VISCOSURGICAL DEVICE CONTAINED WITHIN THE DUOVISC VISCOELASTIC SYSTEM FROM PH 7.0-7.3 TO PH 7.0-7.4 FOR RELEASE AND PH 7.0-7.5 TO PH 6.8-7.5 FOR STABILITY.
P020003|S002|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Prosthesis, testicular|MENTOR SALINE-FILLED TESTICULAR PROSTHESIS|FAF|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2004|03/18/2004|||OK30|CHANGE INVOLVING THE ENGRAVING PROCESS, A CHANGE IN A RAW MATERIAL SUPPLIER AND A MINOR CHANGE IN THE MOLDING PROCESS.
P960043|S052|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM|MGB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2004|03/18/2004|||APPR|APPROVAL FOR CHANGING TO A NEW SUTURE VENDOR (SURGIPRO II MONOFILAMENT POLYPROPYLENE SUTURE.)
P980049|S013|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ORCHESTRA PROGRAMMER|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/20/2004|03/16/2004|||APPR|APPROVAL FOR ELAVIEW 1.22 UG1 APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER, RAM PATCH P2 FOR ALTO 2 ICD SYSTEM, RAM PATCH TI V5 FOR SYMPHONY AND ELA RHAPSODY PACEMAKERS, AND HSO 2.68 SOFTWARE AND V10+ HARDWARE FOR THE CPR3 PROGRAMMING HEAD.
P980049|S014|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2004|04/15/2004|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE ALTO 2 SHOCK MODULE.
P010012|S024|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EASYTRAK 2 AND EASYTRAK 2 IS-1 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD AND EASYTRAK FINISHING WIRE MODE0|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/2004|08/06/2004|||APPR|APPROVAL FOR CHANGES IN LEAD LENGTHS, ADDITION OF IS-1 CONNECTOR AND ENABLING BIPOLAR PACE/SENSE CAPABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EASYTRAK 2 AND IS INDICATED FOR CHRONIC, LEFT VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS, WHEN USED IN CONJUNCTION WITH A COMPATIBLE GUIDANT CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE.
P860004|S059|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2004|03/17/2004|||APPR|APPROVAL FOR: THE ADDITION OF TIME LABELS AND A DAILY DOSE FILED TO THE PROGRAMMING SCREENS; THE ADDITION OF RECENTLY APPROVED CATHETER MODELS, MODEL 8731 AND MODEL 8749, TO THE DROP-DOWN LIST; CHANGES TO THE SCREEN USED TO ENTER THE DEMO MODE, AND THE RESULTING UPDATES TO THE PROGRAMMING GUIDES.
P990026|S022|ANIMAS CORP.|200 LAWRENCE DR.||WEST CHESTER|PA|19380||INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY|GLUCOWATCH G2 BIOGRAPHER|NCT|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/26/2004|06/22/2004|||APPR|APPROVAL FOR MULTIPLE-PATIENT USE OF THE GLUCOWATCH G2 BIOGRAPHER.
P030019|S001|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2004|08/06/2004|||APPR|APPROVAL FOR AN ALTERNATE RAW MATERIAL SOURCE.
P970058|S019|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2004|04/07/2004|||APPR|APPROVAL FOR THE USE OF THE IMAGECHECKER SYSTEM WITH THE HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHIC SYSTEM AND EQUIVALENT PRIVATE LABEL DEVICES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER  M5000D (DIGITAL MAMMOGRAPHY ONLY) AND IMAGECHECKER M5000DM (DIGITAL AND ANALOG MAMMOGRAPHY).  THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.2.  THE INDICATIONS FOR USE ARE: THE IMAGECHECKER M5000D/DM IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P930039|S019|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MEDTRONIC CAPSUREFIX NOVUS|DTB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2004|06/08/2004|||APPR|APPROVAL TO MARKET THESE LEAD MODELS MANUFACTURED USING MED 2000 SILICONE ADHESIVE.
P830061|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPUSRE SP/SENSE SP NOVUS|DTB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2004|06/08/2004|||APPR|APPROVAL TO MARKET THESE LEAD MODELS MANUFACTURED USING MED 2000 SILICONE ADHESIVE.
P850089|S053|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|CAPSURE SP NOVUS Z NOVUS|DTB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2004|06/08/2004|||APPR|APPROVAL TO MARKET THESE LEAD MODELS MANUFACTURED USING MED 2000 SILICONE ADHESIVE.
P980035|S036|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/02/2004|03/31/2004|||APPR|APPROVAL FOR THE ADDITION OF THE ATRIAL CAPTURE MANAGEMENT (ACM) AND POST MODE SWITCH OVERDRIVE PACING (PMOP) FEATURES TO ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E1DR01, E1DR03, E1DR06, AND E1DR21.  IN ADDITION, YOU REQUESTED APPROVAL FOR MINOR UPDATES TO THE ASSOCIATED PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE.
P000053|S003|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2004|03/24/2004|||OK30|CHANGE IN MOLDING VENDORS, FROM IN-HOUSE PRODUCTION TO PURCHASE FORM AN OUTSIDE VENDOR.
P000049|S011|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2004|03/24/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD WHICH INVOLVES A CHANGE TO THE BIOBURDEN SAMPLING PLAN TO ELIMINATE REDUNDANT QUARTERLY TESTING.
P980049|S015|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ORCHESTRA PROGRAMMER|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2004|05/04/2004|||APPR|APPROVAL FOR TWO ADDITION FEATURES (TELASSISTANCE AND CLINICAL REGISTRY) TO THE ELAVIEW 1.22 UG APPLICATION SOFTWARE.
P870072|S028|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2004|08/03/2004|||APPR|APPROVAL FOR A MODIFICATION TO THE CIRCUITRY ASSOCIATED WITH THE BATTERY SUPERVISOR CHIP USED IN THE BATTERY PACKS THAT PROVIDE POWER FOR THE TLC-II PORTABLE PNEUMATIC DRIVER.
P960058|S034|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/2004|07/19/2004|||APPR|APPROVAL FOR AN ALTERNATE ELECTRODE CONFIGURATION FOR THE HIRES90K IMPLANT.  THIS ALTERNATE ELECTRODE IS A MODIFIED VERSION OF THE CURRENT HIFOCUS ELECTRODE, IDENTIFIED AS HIFOCUS HELIX ELECTRODE.
P000009|S011|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TACHOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2004|04/22/2004|||APPR|APPROVAL FOR THE AUTOMATIC BATTERY MANAGEMENT FEATURE FOR THE TACHOS FAMILY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5.
P980016|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INTRINSIC 30 DUAL CHAMBER INPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/2004|06/25/2004|||APPR|APPROVAL FOR THE MEDTRONIC INTRINSIC 30 MODEL 7287 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WITH MODEL 9996 APPLICATION SOFTWARE AND MEDTRONIC INTRINSIC MODEL 7288 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WITH MODEL 9997 APPLICATION SOFTWARE, WHICH ARE INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
P000058|S007|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/2004|03/30/2004|||APPR|APPROVAL FOR A MODIFICATION TO THE PACKAGE INSERT.  SPECIFICALLY, ADDING THE FOLLOWING ADDITIONAL EVENTS TO THE "POSSIBLE ADVERSE EVENTS" SECTION OF THE INSERT: "EDEMA (SWELLING), INFLAMMATION, ERYTHEMATOUS, ALLERGIC REACTION, DYSPHASIA, ITCHING, ANAPHYLACTIC REACTION, ELEVATED ERYTHROCYTE SEDIMENTATION RATE, PAIN, HEMATOMA."
P840001|S072|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITRELL 3, SYNERGY AND SYNGERY VERSITREL SPINAL CORD STIMULATION SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/2004|04/15/2004|||APPR|APPROVAL TO USE EALSTHANE RESINS AS ALTERNATE MATERIALS TO PELLETHANE RESINS IN LEADS, EXTENSIONS AND ACCESSORIES.  THE FOLLOWING LEADS, EXTENSIONS AND ACCESSORIES WILL BE AFFECTED: MODEL 3487A - PISCES QUAD, MODEL 3887 - PISCES QUAD COMPACT, MODEL 3888 - PISCES QUAD PLUS, MODEL 3890 - PISCES Z QUAD, MODEL 3891 - PISCES Z QUAD COMPACT, MODEL 3892 - PISCES Z QUAD PLUS, MODEL 3898 - PISCES OCTAD, MODEL 3998 - SPECIFY, MODEL 3982A - SYMMIX, MODEL 3861 - TEMPORARY SCREENING LEAD, MODEL 3862 - VERIFY, MODEL 3587A - RESUME II, MODEL 3986A RESUMETL, MODEL 7471 EXTENSION, MODEL 7489 EXTENSION, MODEL 7495 EXTENSION, MODEL 7495LZ EXTENSION, MODEL 7496 EXTENSION, MODEL 7498 EXTENSION, MODEL 3550-09 - ACCESSORY KIT, MODEL 7441 - ACCESSORY KIT AND MODEL 7441NC - ACCESSORY KIT.
P010020|S001|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICO N NEOSPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2004|03/24/2004|||OK30|CHANGE IN MOLDING VENDORS, FROM IN-HOUSE PRODUCTION TO PURCHASE FORM AN OUTSIDE VENDOR.
P900009|S019|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 2000+|LPQ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2004|05/07/2004|||APPR|APPROVAL FOR THE ADDITION OF 2 DIODES IN SERIES WITH THE POSITIVE LEAD OF THE 5-CELL BATTERY PACK ON THE EXOGEN 2000+ LOW INTENSITY ULTRASOUND FRACTURE HEALING SYSTEM.
P810046|S216|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|VOYAGER RX CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/2004|06/18/2004|||APPR|APPROVAL FOR THE VOYAGER RX CORONARY DILATATION CATHETER.  THE DEVICE, AS MODIFIED, IS INDICATED FOR 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, 2) BALLOON DILATATION OF A CORONARY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, AND 3) BALLOON DILATATION OF STENT AFTER IMPLANTATION (TESTING INCLUDING THE FOLLOWING GUIDANT STENTS: MULTI-LINK: PIXEL AND PENTA AND ZETA CORONARY STENT SYSTEMS).
P020031|S001|MICROSULIS MEDICAL LTD.|PARKLANDS BUSINESS PARK||DENMEAD HAMPSHIRE||PO7 6||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MICROSULIS MICROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/2004|05/25/2005|||APPR|APPROVAL FOR THE SINGLE USE MEA APPLICATOR.
P840002|S011|CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|STAT PACE II|LPA|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/09/2004|10/01/2004|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT MARTECH MEDICAL PRODUCTS, BAJA CALIFORNIA, MEXICO AND HARLEYSVILLE, PENNSYLVANIA.
P000025|S014|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSARCI100 COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/2004|11/17/2004|||APPR|APPROVAL FOR THE PULSARCI100 COCHLEAR IMPLANT, A MEMBER OF COMBI C40+ COCHLEAR IMPLANT SYSTEM.
P020047|S002|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2004|03/22/2004|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT GUIDANT CORPORATION, GUIDANT IRELAND, CLONMEL, IRELAND.
P010012|S025|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EASYTRAK 3 CORONARY VENOUS STERIOD ELUTING BIPOLAR PACE/SENSE LEAD|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/2004|08/06/2004|||APPR|APPROVAL FOR CHANGES IN FIXATION DESIGN, LEAD LENGTHS AND ENABLING BIPOLAR PACE/SENSE CAPABILITY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EASYTRAK 3 AND IS INDICATED FOR CHRONIC, LEFT VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS, WHEN USED IN CONJUNCTION WITH A COMPATIBLE GUIDANT CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE.
P930038|S038|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULARCLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2004|04/08/2004|||OK30|CHANGE TO INCLUDE AN ADDITIONAL VENDOR.
P010068|S003|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|OAD|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/11/2004|04/02/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., JUAREZ, MEXICO.
P000053|S004|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS SPHINCTER 800 URINARY PROSTHESIS|EZY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/11/2004|05/07/2004|||APPR|APPROVAL FOR A NEW MANUFACTURING PROCEDURE TO PRODUCE THE CUFF BACKING, A DESIGN CHANGE TO THE THICKNESS OF THE CUFF BACKING, A MATERIAL CHANGE IN THE SILICONE, AND A PROMOTIONAL CLAIM REGARDING THE CUFF WEAR CHARACTERISTICS OF THE MODIFIED DESIGN.
P950022|S018|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA DEFIBRILLATION LEAD FAMILY|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/11/2004|04/21/2004|||APPR|APPROVAL FOR MODIFICATION TO THE RIATA DEFIBRILLATION LEAD FAMILY TO INCLUDE INTEGRATED BIPOLAR LEADS (MODELS 1560, 1561, 1562, 1590, 1591 AND 1592).
P990041|S005|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-EBK PLUS|LOM|MI|30-Day Notice||N|03/11/2004|03/26/2004|||OK30|CHANGE IN THE QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL USED IN THE PREPARATION OF COATED STRIPS OF THE ETI-AB-EBK PLUS WHICH IS AN IN VITRO ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B E ANTIGEN IN HUMAN SERUM OR PLASMA.
P990043|S006|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-EBK PLUS|LOM|MI|30-Day Notice||N|03/11/2004|03/26/2004|||OK30|CHANGE IN THE QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL USED IN THE PREPARATION OF COATED STRIPS OF THE ETI- EBK PLUS WHICH IS AN IN VITRO ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN IN HUMAN SERUM OR PLASMA.
P030006|S001|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|03/11/2004|04/15/2004|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P960043|S053|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE 6FR SUTURE-MEDIATED CLOSURE (SMC) SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/2004|04/22/2004|||APPR|APPROVAL FOR REVISED INSTRUCTIONS FOR USE, INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
P980012|S006|WORLD HEART, INC.|7799 PARDEE LN.||OAKLAND|CA|94621||Ventricular (assisst) bypass|WORLD HEART NOVACOR N100PC AND N100PCQ :VAS|DSQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/10/2004|07/21/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE DEVICE SYSTEM LABELING; SPECIFICALLY, CHANGES TO (ONLY) THE DEVICE RELIABILITY PORTION OF SECTION 7 (CLINICAL STUDY) OF THE PHYSICIAN'S MANUAL.
P900023|S040|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2004|06/28/2004|||APPR|APPROVAL FOR THE ADDITION OF TWO INFLOW CANNULAE (MALLEABLE 42 FR. AND 32 FR.) TO BE ADDED TO THE CURRENTLY APPROVED CANNULAE USED WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM.
P030019|S003|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2004|04/09/2004|||OK30|ADDITIONAL PROCESS CONTROL STEP USED IN THE PRODUCTION OF ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN.
P030024|S001|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2004|04/02/2004|||OK30|REPLACEMENT OF KEY EQUIPMENT USED IN PERFORMING THE COATED WELL TEST PROCEDURE AND THE ACCEPTANCE CRITERIA ASSOCIATED WITH ITS USE.  IN ADDITION, THE COATED WELL SAMPLING PLAN, RANDOMIZATION METHODS FOR SAMPLING, AND TEST ERROR CORRECTION METHODS HAVE BEEN IMPROVED TO FURTHER ENSURE BATCH QUALITY AND REDUCTION OF PRODUCTION WASTE FOR THE MANUFACTURE OF THE COATED MICROWELLS.
P010003|S003|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)|MUQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2004|05/03/2004|||APPR|APPROVAL FOR A DISPOSABLE DUAL-BARREL PISTON-DRIVEN SYRINGE DISPENSING SYSTEM AS AN ALTERNATE TO THE CURRENT DUAL-BARREL REUSABLE RATCHETING PISTON-DRIVEN CARTRIDGE SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BG3500 AND IS INDICATED FOR USE AS AN ADJUNCT TO STANDARD METHODS OF ACHIEVING HEMOSTASIS (SUCH AS SUTURES AND STAPLES) IN ADULT PATIENTS IN OPEN SURGICAL REPAIR OF LARGE VESSELS (SUCH AS AORTA, FEMORAL, AND CAROTID ARTERIES).
P910061|S011|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2004|06/14/2004|||APPR|APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM.  STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY.  THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH &  LOMB, INC., CLEARWATER, FLORIDA.
P840039|S053|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2004|06/14/2004|||APPR|APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM.  STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY.  THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH &  LOMB, INC., CLEARWATER, FLORIDA.
P880090|S020|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2004|06/14/2004|||APPR|APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM.  STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY.  THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH &  LOMB, INC., CLEARWATER, FLORIDA.
P860047|S016|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT|LZP|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2004|06/14/2004|||APPR|APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM.  STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY.  THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH &  LOMB, INC., CLEARWATER, FLORIDA.
P000058|S008|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMAR TAPERED FUSION DEVICE|NEK|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2004|04/16/2004|||APPR|APPROVAL OF THE ELIMINATION OF THE REAMING STEP IN THE SURGICAL IMPLANTATION PROCEDURES FOR THE LT CAGE PEEK LUMBAR TAPERED FUSION DEVICE, THE LT CAGE LUMBER TAPERED FUSION DEVICE, AND THE INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE.
P970015|S026|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE|MAX|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2004|04/16/2004|||APPR|APPROVAL OF THE ELIMINATION OF THE REAMING STEP IN THE SURGICAL IMPLANTATION PROCEDURES FOR THE LT CAGE PEEK LUMBAR TAPERED FUSION DEVICE, THE LT CAGE LUMBER TAPERED FUSION DEVICE, AND THE INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE.
P970015|S027|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|LT-CAGE LUMBAR TAPERED FUSION DEVICE|MAX|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2004|04/16/2004|||APPR|APPROVAL OF THE ELIMINATION OF THE REAMING STEP IN THE SURGICAL IMPLANTATION PROCEDURES FOR THE LT CAGE PEEK LUMBAR TAPERED FUSION DEVICE, THE LT CAGE LUMBER TAPERED FUSION DEVICE, AND THE INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE.
P910023|S072|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/22/2004|04/09/2004|||APPR|APPROVAL FOR THE USE OF TANTALUM CAPACITORS IN EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T PULSE GENERATORS (P910023/S072) AND THE MODEL 3307 PROGRAMMER SOFTWARE V 4.6M (P830045/S091 AND P880086/S099).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T AND MODEL 3307 PROGRAMMER SOFTWARE V 4.6M.
P970020|S045|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|(ASC)MULTI-LINK CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2004|03/22/2004|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT GUIDANT CORPORATION, GUIDANT IRELAND, CLONMEL, IRELAND.
P880086|S099|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/22/2004|04/09/2004|||APPR|APPROVAL FOR THE USE OF TANTALUM CAPACITORS IN EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T PULSE GENERATORS (P910023/S072) AND THE MODEL 3307 PROGRAMMER SOFTWARE V 4.6M (P830045/S091 AND P880086/S099).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T AND MODEL 3307 PROGRAMMER SOFTWARE V 4.6M.
P830045|S091|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/22/2004|04/09/2004|||APPR|APPROVAL FOR THE USE OF TANTALUM CAPACITORS IN EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T PULSE GENERATORS (P910023/S072) AND THE MODEL 3307 PROGRAMMER SOFTWARE V 4.6M (P830045/S091 AND P880086/S099).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EPIC+ VR MODEL V-196T AND EPIC+ DR MODEL V-239T AND MODEL 3307 PROGRAMMER SOFTWARE V 4.6M.
P890055|S018|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN SERIES 3000 IMPLANTABLE INFUSION PUMPS|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/22/2004|03/25/2004|||APPR|APPROVAL FOR THE FOLLOWING:  MINOR DESIGN AND MATERIAL MODIFICATIONS TO THE CONNECTOR; ADDITION OF A SILICONE STRAIN RELIEF SLEEVE; AND MINOR DESIGN AND MATERIAL MODIFICATIONS TO THE ANCHORS.
P020045|S004|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/22/2004|05/03/2004|||APPR|APPROVAL FOR MODIFICATIONS MADE TO THE FREEZOR CARDIAC CRYOABLATION CATHETER APPROVED UNDER P020045.
P000029|S007|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2004|04/21/2004|||OK30|CHANGES TO THE ACCESSORY DEVICE, THE DEFLUX METAL NEEDLE, TO INCLUDE ADDITION OF BIOBURDEN AND STERILITY TESTING AND TO REMOVE THE BIOINDICATOR USAGE DURING ORDINARY MANUFACTURING.
P010032|S010|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2004|04/15/2004|||APPR|APPROVAL FOR THE USE OF THE C-SERIES LAMITRODE SPINAL CORD STIMULATION LEADS, MODEL NUMBERS 3245 (LAMITRODE 44C) AND 3289 (LAMITRODE 88C) FOR USE WITH THE ANS GENESIS NEUROSTIMLATION (IPG) MODEL 3608, THE ANS GENESIS XP NEUROSTIMULATION (IPG) MODEL 3609, THE ANS GENESIS DUAL XP NEUROSTIMULATION (IPG) MODEL 3644 AND THE ANS GENESIS G4 NEUROSTIMULATION (IPG) MODEL 3604 WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P020014|S007|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/24/2004|04/08/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT VENUSA, LTD., CHIHUAHUA, MEXICO.
P860004|S060|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2004|03/29/2004|||APPR|APPROVAL FOR THE FOLLOWING CHANGES INVOLVING THE MOTOR COIL FOR THE SYNCHROMED II IMPLANTABLE INFUSION PUMP:  1) CHANGE FROM A CRIMPED TO A HEAT-WELDED MOTOR COIL CONNECTOR PIN; AND 2) CHANGE TO A SILICON VARNISH SURFACE COATING OF THE MOTOR COIL, THE SAME COATING AS APPLIED TO THE MOTOR COIL OF THE SYNCHROMED EL IMPLANTABLE INFUSION PUMP.
P900023|S041|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2004|06/28/2004|||APPR|APPROVAL FOR THE ADDITION OF THE SEWING CUFF FOR CANNULA PLACEMENT FOR THE USE WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM.
P030025|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2004|08/06/2004|||APPR|APPROVAL FOR THE ADDITION OF A NEW SUPPLIER FOR SOLVENTS USED IN THE FABRICATION OF THE POLYMER COATING FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM.
P980016|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 7278 MAXIMO DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND MODEL 7232 MAXIMO VR SINGLE CHAM|LWS|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/26/2004|04/08/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEDREL, JUNCOS, PUERTO RICO.
P010012|S026|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A|NIK|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|03/29/2004|09/14/2004|04M-0430|09/24/2004|APPR|APPROVAL FOR THE CONTAK CD, CONTAK CD 2, RENEWAL, AND RENEWAL 3 DEVICES.  THESE DEVICES ARE INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS.
P840039|S054|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2004|05/27/2004|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT COSMED, INC., PLAINFIELD, NEW JERSEY.
P910061|S012|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2004|05/27/2004|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT COSMED, INC., PLAINFIELD, NEW JERSEY.
P880090|S021|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2004|05/27/2004|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT COSMED, INC., PLAINFIELD, NEW JERSEY.
P860047|S018|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2004|05/27/2004|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT COSMED, INC., PLAINFIELD, NEW JERSEY.
P970029|S009|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|SOLARGEN 2100S LASER|MNO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/24/2004|12/23/2004|||APPR|APPROVAL FOR THE SOLARGEN 2100S LASER TO REPLACE THE TMR2000 LASER IN THE CARDIOGENESIS TMR HOLMIUM LASER SYSTEM.  THE SOLARGEN 2100S WILL BE MANUFACTURED BY NEW STAR LASERS, INC. OF ROSEVILLE, CALIFORNIA.
P910007|S010|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ABBOTT ARCHITECT TOTAL PSA ASSAY|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/2004|04/28/2004|||APPR|APPROVAL FOR THE ABBOTT ARCHITECT TOTAL PSA ASSAY TO BE USED ON THE ARCHITECT I2000SR PLATFORM, A MEMBER OF THE ARCHITECT I2000 INSTRUMENT FAMILY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME ARCHITECT TOTAL PSA ASSAY AND IS INDICATED:  THE ARCHITECT TOTAL PSA ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPSIN [PSA-ACT]) IN HUMAN SERUM:  1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER.  PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.  2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
P980007|S004|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ABBOTT ARCHITECT FREE PSA|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/2004|05/07/2004|||APPR|APPROVAL FOR ADDITION OF THE ARCHITECT FREE PSA TO THE I2000SR PLATFORM, A MEMBER OF THE ARCHITECT I2000 INSTRUMENT FAMILY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT FREE PSA AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM.  THE ARCHITECT FREE PSA IS INTENDED TO BE USED IN CONJUNCTION WITH THE ARCHITECT TOTAL PSA ASSAY IN MEN AGED 50 YEARS OR OLDER WITH TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND DRE NON-SUSPICIOUS FOR CANCER TO DETERMINE THE % FREE PSA VALUE.  THE ARCHITECT % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE.
P920047|S023|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER RPM CARDIAC ABLATION CATHETERS|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/2004|05/18/2004|||APPR|APPROVAL FOR A CHANGE IN THE EXPIRATION DATE FROM ONE-YEAR TO THREE-YEARS.
P000006|S004|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|MENTOR INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2004|04/28/2004|||OK30|CHANGE IN THE RAW MATERIAL SUPPLIER OF A CHEMICAL USED IN THE MANUFACTURING OF MENTOR'S INFLATABLE PENILE PROSTHESIS.
P000049|S012|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD|MLV|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/2004|05/10/2004|||APPR|APPROVAL FOR THE ADDITION OF A WARNING TO THE LABELING THAT PROTAMINE SULFATE SHOULD NOT BE USED FOR HEPARIN REVERSAL BECAUSE OF THE POTENTIAL FOR THROMBUS FORMATION.
P930038|S039|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/2004|04/30/2004|||APPR|APPROVAL TO ADD LANGUAGE THAT INSTRUCTS THE USER IN THE METHOD ASSOCIATED WITH REPUNCTURE OF THE SAME LOCATION OF PREVIOUS ANGIO-SEAL USE WHEN THE PREVIOUS USE OCCURRED IN LESS THAN OR EQUAL TO 90 DAYS.
P020023|S004|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice||N|04/05/2004|05/05/2004|||OK30|ADDITION OF A 1 ML VIAL SIZE FOR THE RESTYLANE INJECTABLE GEL.
P990044|S005|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-CORE-IGMK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2004|04/30/2004|||OK30|CHANGE IN THE QUALITY CONTROL TESTS USED TO DETERMINE SPECIFIC ATTRIBUTES OF INCOMING RAW MATERIALS.
P990045|S006|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-COREK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2004|04/30/2004|||OK30|CHANGE IN THE QUALITY CONTROL TESTS USED TO DETERMINE SPECIFIC ATTRIBUTES OF INCOMING RAW MATERIALS.
P790017|S082|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|NC STORMER MX2/OTW BALLOON DILATATION CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/05/2004|03/04/2005|||APPR|APPROVAL FOR ADDITION OF THE NC STORMER MX2 CATHETER WITH TWO ADDITIONAL LENGTHS (AS A MODIFIED VERSION OF THE APPROVED NC STORMER MX CATHETER) AND THE ADDITION OF TWO ADDITIONAL LENGTHS FOR THE NC STORMER OTW CATHETER.
P990043|S007|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2004|04/30/2004|||OK30|CHANGE IN THE QUALITY CONTROL TESTS USED TO DETERMINE SPECIFIC ATTRIBUTES OF INCOMING RAW MATERIALS.
P990042|S007|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-AUK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2004|04/30/2004|||OK30|CHANGE IN THE QUALITY CONTROL TESTS USED TO DETERMINE SPECIFIC ATTRIBUTES OF INCOMING RAW MATERIALS.
P990041|S006|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2004|04/30/2004|||OK30|CHANGE IN THE QUALITY CONTROL TESTS USED TO DETERMINE SPECIFIC ATTRIBUTES OF INCOMING RAW MATERIALS
P990038|S006|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-MAK-2-PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2004|05/03/2004|||OK30|CHANGE IN THE QUALITY CONTROL TESTS USED TO DETERMINE SPECIFIC ATTRIBUTES OF INCOMING MATERIALS.
P990038|S007|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-MAK-2 PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2004|04/30/2004|||OK30|CHANGE IN THE QUALITY CONTROL SPECIFICATIONS RELATED TO THE POSITIVE CONTROL OD AND CONCENTRATION LIMITS FOR KIT AND COMPONENT RELEASE.
P020009|S015|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS|MAF|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2004|05/05/2004|||APPR|APPROVAL TO IMPLEMENT THE FOLLOWING:  1) THE ADDITION OF AN ADDITIONAL IN-PROCESS INSPECTION,  2) MODIFICATION OF A CURRENT IN-PROCESS INSPECTION, AND  3) MODIFICATION OF A MANUFACTURING PROCESS TO ADDRESS COMPLAINTS RELATED TO FAILURE OF THE DELIVERY SYSTEM BALLOON TO PROPERLY DEFLATE FOLLOWING STENT DEPLOYMENT.
P030025|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS|NIQ|CV|Special (Immediate Track)||N|04/05/2004|05/05/2004|||APPR|APPROVAL TO IMPLEMENT THE FOLLOWING:  1) THE ADDITION OF AN ADDITIONAL IN-PROCESS INSPECTION,  2) MODIFICATION OF A CURRENT IN-PROCESS INSPECTION, AND  3) MODIFICATION OF A MANUFACTURING PROCESS TO ADDRESS COMPLAINTS RELATED TO FAILURE OF THE DELIVERY SYSTEM BALLOON TO PROPERLY DEFLATE FOLLOWING STENT DEPLOYMENT.
P980023|S017|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|KENTROX RV-S STEROID AND KENTROX SL-2 STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2004|09/30/2004|||APPR|APPROVAL FOR ADDITION OF A STEROID COLLAR TO SINGLE COIL AND DUAL COIL LEAD VERSIONS, AND MODIFICATIONS TO THE CONDUCTOR COIL AND FIXATION HELIX.
P940040|S003|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST|MWA|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2004|04/22/2004|||OK30|CHANGE TO THE MANUFACTURING PROCESS OF THE DEVICE TO INCORPORATE A TERMINAL 0.2UM FILTRATION STEP TO THE AVIDIN-HORSERADISH PEROXIDASE (HRP) BGG CONJUGATE REAGENT MANUFACTURING PROCESS TO ENSURE THE REMOVAL OF ADVENTITIOUS AGENTS REMAINING IN THE REAGENT FOLLOWING FORMULATION.
P910065|S005|TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ST AIA-PACK PA|LTJ|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/2004|05/25/2004|||APPR|APPROVAL OF THE TOSOH ST AIA-PACK PA ASSAY TO BE USED ON THE TOSOH AIA-360 AND TOSOH AIA-1800 AUTOMATED IMMUNOASSAY SYSTEMS, MEMBERS OF THE TOSOH AIA AUTOMATED IMMUNOASSAY SYSTEM FAMILY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME ST AIA-PACK PA AND IS INDICATED FOR:  ST AIA-PACK PA IS DESIGNED FOR IN VITRO DIAGNOSTIC USE ONLY FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM ON TOSOH AIA NEX*IA, AIA-600 II, AIA-1800 AND AIA-360 ANALYZERS.  THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER (CAP) IN MEN FIFTY YEARS OF AGE AND OLDER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER.  THIS DEVICE IS FURTHER INDICATED FOR THE SERIAL MEASUREMENT OF PSA IN HUMAN SERUM TO BE USED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATIC CANCER.
P000052|S024|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2004|05/04/2004|||APPR|APPROVAL FOR THE ADDITION OF A SECONDARY WIPE STATION TO THE MANUFACTURING PROCESS FOR THE GDT-P32-1 SOURCE WIRES.
P960040|S043|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY 2 SYSTEM GUIDE|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/08/2004|05/04/2004|||APPR|APPROVAL FOR MINOR UPDATES TO THE VITALITY 2 SYSTEM GUIDE CLINICAL SECTION.
P990052|S011|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE|MPV|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2004|11/23/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MED-EL MEDICAL ELECTRONICS, INNSBRUCK, AUSTRIA.
P930031|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2004|05/07/2004|||OK30|CHANGE IN THE MANUFACTURING MATERIAL USED IN THE MANUFACTURE OF THE EXTERIOR TUBE FOR THE DEVICE.
P980033|S010|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2004|05/07/2004|||OK30|CHANGE IN THE MANUFACTURING MATERIAL USED IN THE MANUFACTURE OF THE EXTERIOR TUBE FOR THE DEVICE.
P020006|S004|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MAILSTOP: MB-16|MARLBOROUGH|MA|01752||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|ENTERYX PROCEDURE KIT|LNM|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2004|05/26/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT LIFE SCIENCE OUTSOURCING, BREA, CALIFORNIA.  FINAL ASSEMBLY OF THE ENTERYX INJECTOR AND THE KITTING PROCEDURES WILL BE PERFORMED AT THIS FACILITY.
P010032|S011|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2004|05/05/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADVANCED NEUROMODULATION SYSTEMS, INC., PLANO, TEXAS.
P980048|S003|SULZER SPINE-TECH|7375 BUSH LAKE RD.||MINNEAPOLIS|MN|55439||Intervertebral fusion device with bone graft, lumbar|BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE|MAX|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/2004|10/06/2004|||APPR|APPROVAL FOR THE BAK/C VISTA DEVICE, A MODIFICATION TO THE ALREADY APPROVED BAK/C DEVICE.  THE BAK/C VISTA DIFFERS FROM THE BAK/C DEVICE IN THE FOLLOWING MANNERS: 1) THE BAK/C VISTA HAS TWO LARGE OFFSET SUPERIOR-INFERIOR (SI) HOLES FOR BONE INGROWTH WHEREAS THE BAK/C HAS MANY SMALL HOLES AT VARIOUS CIRCUMFERENTIAL AND LONGITUDINAL LOCATIONS, AND 2) THE BAK/C VISTA IS MADE OF PEEK OPTIMA LT1 AND THE BAK/C IS MADE OF TITANIUM (TI-6A1-4V).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAK/C VISTA AND IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE DDD) OF THE CERVICAL SPINE WITH ACCOMPANYING RADICULAR SYMPTOMS AT ONE DISC LEVEL.  DDD IS DEFINED AS DISCOGENIC PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.  BAK/C IMPLANTS ARE USED TO FACILITATE FUSION IN THE CERVICAL SPINE AND ARE PLACED VIA AN ANTERIOR APPROACH AT THE C-3 TO C-7 DISC LEVELS USING AUTOGRAFT BONE.
P020047|S003|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK MINI VISION CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/12/2004|09/10/2004|||APPR|APPROVAL FOR THE NEW PRODUCT LINE, THE MULTI-LINK MINI VISION CORONARY STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL DIAMETERS FROM 2.0 TO 2.5 MM.
P990066|S017|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/12/2004|06/07/2004|||APPR|APPROVAL FOR A NAME CHANGE FOR THE SENOGRAPHE 2100D FFDM SYSTEM TO THE SENOGRAPHE DS FFDM SYSTEM.
P000009|S012|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG|MRM|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/12/2004|06/22/2004|||APPR|APPROVAL FOR CHANGES TO THE CURRENT FDA-APPROVED LABELING FOR BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P000010|S003|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST,VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2004|05/06/2004|||OK30|INCORPORATION OF A TERMINAL 0.2 UM FILTRATION STEP TO THE AVIDIN-HORSERADISH PEROXIDASE (HRP) BGG CONJUGATE REAGENT MANUFACTURING PROCESS.  THE SUBMISSION IDENTIFIED THE CHANGE FOR WHICH THE APPROVAL IS BEING REQUESTED AND PROVIDES THE RATIONALE FOR THE CHANGE.
P030025|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|REDUCTION IN THE SAMPLING PLAN FOR DESTRUCTIVE BALLOON BURST TESTING.
P020009|S016|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|REDUCTION IN THE SAMPLING PLAN FOR DESTRUCTIVE BALLOON BURST TESTING.
P010012|S027|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD, CONTAK CD 2, EASYTRAK, CONTAK RENEWAL, CONTAK RENEWAL 3|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P830060|S054|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK BIPOLAR ENDOCARDIAL LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P890061|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P910073|S045|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P910077|S045|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX,VENTAK MINI|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P930035|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2,VENTAK P3|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P940031|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR, DISCOVERY, MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P950001|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE,SELUTE PICOTIP|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P960004|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FINELINE,FINELINE II|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P960006|S010|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P960040|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV, VENTAK VR, VENTAK PRIZMALITY, VITALITY 2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2004|05/14/2004|||OK30|CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
P000013|S004|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEONICS ABC/TRIDENT SYSTEMS|MRA|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/2004|08/16/2004|||APPR|APPROVAL OF THE TRIDENT "T" SHELL FOR USE WITH THE TRIDENT ALUMINA INSERT.  THE TRIDENT "T" SHELL, WHICH FEATURES A THICKER SHELL WALL, IS A LINE EXTENSION TO THE TRIDENT ACETABULAR SHELLS PREVIOUSLY APPROVED FOR USE WITH THE TRIDENT ALUMINA INSERT.
P960058|S035|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2004|05/14/2004|||OK30|EXPANSION OF STERILIZATION CAPACITY USING AN ALTERNATE STERILIZATION CHAMBER.
P020023|S005|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2004|05/10/2004|||OK30|THREE CHANGES IN THE MANUFACTURING PROCESSES.
P910023|S073|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2004|05/12/2004|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS RECEIVER SOFTWARE (VERSION 2.0) WHICH ALSO INCLUDES THE SUPPORT FOR THE ST. JUDE MEDICAL EPIC AND ATLAS ICD FAMILIES.
P980035|S037|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|AT500 DDDRP PACING SYSTEM|DXY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|04/16/2004|06/07/2004|||APPR|APPROVAL FOR CHANGES TO THE INVESTIGATIONAL PLAN FOR THE MEDTRONIC'S AT500 DDDRP PACING SYSTEM'S POST-APPROVAL STUDY.
P930014|S014|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER IOL|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/2004|04/29/2004|||APPR|APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.
P810032|S050|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF UV-ABSORBING MULTI-PIECE PC IOL|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/2004|04/29/2004|||APPR|APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.
P840060|S028|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF UV-ABSORBING SINGLE-PIECE PC IOL|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/2004|04/29/2004|||APPR|APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.
P000049|S013|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2004|05/14/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE VENDOR FOR THE DEVICE.
P880087|S010|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF UV-ABSORBING PMMA SINGLE-PIECE ANTERIOR CHAMBER|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/2004|04/29/2004|||APPR|APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY.  PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED.  THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.
P020023|S006|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2004|05/10/2004|||OK30|CHANGES IN INCREASING UTILIZATION FOR SOME OF THE MANUFACTURING PROCESS EQUIPMENT.
P970053|S008|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/19/2004|05/28/2004|||APPR|APPROVAL TO REPLACE THE 60HZ EYETRACKER WITH THE 200 HZ EYETRACKER IN THE NIDEK EC-5000 EXCIMER LASER SYSTEM FOR THE TREATMENT OF MYOPIA AND MYOPIC ASTIGMATISM.
P000049|S014|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2004|05/21/2004|||OK30|CHANGES RELATED TO THE IMPLANT FABRIC.  THE PROPOSED CHANGES INVOLVE TRANSFERRING THE FABRIC HEAT SET AND FABRIC CUT STEPS TO AN ALTERNATE VENDOR.
P960058|S036|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/2004|08/04/2004|||APPR|APPROVAL FOR LABELING CHANGES TO INDICATE THAT THE HIRESOLUTION BIONIC EAR SYSTEM IS SAFE FOR MRI AT LEVELS OF 0.3 TESLA/12 MHZ AND 1.5 TESLA/64 MHZ.
P990038|S008|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-MAK-2 PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2004|05/19/2004|||OK30|CHANGE IN THE MANUFACTURING MATERIALS USED TO PRODUCE THE ETI-MAK-2 PLUS TRACER DILUENT.  THIS CHANGE WAS TO ADD INACTIVATED HORSERADISH PEROXIDASE, 2.5 MG/L, TO THE ETI-MAK-2 PLUS TRACER DILUENT.
P010038|S006|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|ICAD SYSTEM|MYN|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2004|05/21/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SCANOPTICS, INC, MANCHESTER, CONNECTICUT.
P990046|S011|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2004|07/25/2007|||APPR|APPROVAL FOR A CUFF DESIGN CHANGE.
P000058|S009|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/20/2004|04/20/2005|||APPR|APPROVAL FOR TWO CHANGES TO THE PROCESSING OF THE RHBMP-2 COMPONENT OF THE DEVICE - THE USE OF A NEW WORKING CELL BANK AND THE  USE OF A LONGER HOLD-TIME (<=120 HOURS AT 2-8 DEGREES C COMPARED TO THE CURRENT 24 HOURS) FOR THE MATREX CELLUFINE SULFATE COLUMN.
P980035|S038|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/2004|04/28/2005|||APPR|APPROVAL FOR THE MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT.  THE CEVICE IS INDICATE FOR THE FOLLWOING: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY. 2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK, SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK, SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS, AND BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS.  THE DEVICE IS ALSO INDICATED FOR DUAL CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.  DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CINDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, HICH INCLUDE:  VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT AND VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SIUNS RHYTHM.  ANTITACHYCARDIA PACING (ATP) IS INDICATED FOR TERMINATINO OF ATRIAL TACHYARRHYMIAS IN BRADYCARDIA PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.  ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN BRADYCARDIA PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P020050|S001|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track No User Fee|Express GMP Supplement|N|05/21/2004|06/04/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WAVELIGHT LASER TECHNOLOGIE AG, PRESSATH, GERMANY.
P030008|S001|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track No User Fee|Express GMP Supplement|N|05/21/2004|06/04/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WAVELIGHT LASER TECHNOLOGIE AG, PRESSATH, GERMANY.
P830079|S015|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT COLLAGEN HEMOSTAT|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2004|06/22/2004|||APPR|APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO; AND A LOWERED MINIMUM RADIATION STERILIZATION DOSE.
P010038|S007|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|ICAD SYSTEM|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2004|05/19/2004|||APPR|APPROVAL FOR REPLACING THE ICAD SYSTEM'S CAD SOFTWARE WITH THE SECOND LOOK CAD SOFTWARE AND INCREASING THE SYSTEM MEMORY FROM 1 GIGABYTE TO 2 GIGABYTES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK 200 AND IS INDICATED FOR:  SECOND LOOK IS A COMPUTED SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDING VIEWS FROM PATIENTS WITH BREAST IMPLANTS AND IMAGES FROM QUALIFIED FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS, TO BRING TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P980044|S001|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2004|05/27/2004|||OK30|CHANGE IN THE CARTON PACKAGING PROCESS FOR SUPARTZ FROM MANUAL TO AUTOMATED.
P900039|S013|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|NEUGRAFT|MBS|OR|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/2004|06/07/2004|||APPR|APPROVAL FOR THE ADDITION OF THE PRODUCT "NEUGRAFT".  COLLAGRAFT STRIP BONE GRAFT MATRIX (COLLAGRAFT) WAS ORIGINALLY APPROVED BY THE FDA ON JANUARY 27, 1994 (REVIEW OF P900039).  THE PRODUCT CURRENTLY CONTINUES TO BE MARKETED BY THAT NAME.  NEUGRAFT IS IDENTICAL TO COLLAGRAFT STRIP BONE GRAFT MATRIX, EXCEPT THAT THE BRAND NAME ON THE LABELING IS DIFFERENT.  THE LABELING FOR NEUGRAFT INDICATED AND EXPLAINS THAT THE TWO PRODUCTS ARE THE SAME, BUT ARE SOLD THROUGH DIFFERENT DISTRIBUTION CHANNELS.  AS PROPOSED, THE PRODUCT WILL CONTINUE TO BE SOLD USING BOTH NAMES COLLAGRAFT AND NEUGRAFT.  THERE WILL BE NO CHANGE AFFECTING SAFETY AND EFFECTIVENESS FOR THIS PRODUCT.
P860040|S016|WAVETOUCH TECHNOLOGIES, LLC|15970 BERNARDO CENTER DR.||SAN DIEGO|CA|92127||Lenses, soft contact, extended wear|BIOCURVE SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Express GMP Supplement|N|05/05/2004|05/28/2004|||APPR|APPROVAL TO RELOCATE SOME MANUFACTURING PROCESSES TO THE SITE LOCATED AT AMERICAN BIOCURVE, INC., SAN DIEGO, CALIFORNIA.
P000014|S007|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2004|05/14/2004|||OK30|REPLACEMENT OF KEY EQUIPMENT USED IN PERFORMING THE COATED WELL TEST PROCEDURE AND THE ACCEPTANCE CRITERIA ASSOCIATED WITH ITS USE.  IN ADDITION, THE COATED WELL SAMPLING PLAN, RANDOMIZATION METHODS FOR SAMPLING, AND TEST ERROR CORRECTION METHODS HAVE BEEN IMPROVED TO FURTHER ENSURE BATCH QUALITY AND REDUCE PRODUCTION WASTE.  THE COATED WELL TEST PROCEDURE IS USED TO VERIFY AN ACCEPTABLE LEVEL OF WELL-TO-WELL PRECISION AND OUTLIER-LEVEL INCIDENCE IN THE COATED WELLS MANUFACTURED FOR THE VITROS ANTI-HBS ASSAY.
P000046|S009|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II,SHELLGEL AND COEASE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2004|06/04/2004|||OK30|ADDITION OF A QUALITY TEST METHOD FOR STAARVISC II, SHELLGEL AND COEASE.
P030019|S004|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2004|06/04/2004|||OK30|ADDITION OF A NEW QUALITY CONTROL TEST.
P010025|S005|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/07/2004|02/18/2005|||APPR|APPROVAL FOR ADDITION OF AUTOMATIC EXPOSURE (AEC) SYSTEM, AND RELATED CHANGES IN OPERATOR'S MANUAL AND QC TEST AND QC MANUAL UNDER MQSA.
P020045|S005|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Real-Time Process||N|05/10/2004|06/10/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE FREEZOR. AND FREEZOR. XTRA CRYOABLATION SYSTEMS.
P020004|S006|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROTHESIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2004|06/02/2004|||APPR|APPROVAL FOR A LOW PERMEABILITY  VERSION OF THE GORE EXCLUDER BIFURCATED ENDOPROSTHESIS.
P990004|S006|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/10/2004|06/28/2004|||APPR|APPROVAL FOR REVISION ON THE LABELING TO INCLUDE THE USE OF THE PRODUCT WITH THROMBIN.
P020045|S006|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2004|10/26/2004|||APPR|APPROVAL FOR THE 9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE, A MODIFICATION TO THE FREEZOR XTRA CARDIAC CRYOABLATION SYSTEM PREVIOUSLY APPROVED UNDER P020045/S005.  THE DEVICE IS INDICATED FOR MINIMALLY INVASIVE CARDIAC SURGERY PROCEDURES, INCLUDING SURGICAL TREATMENT OF CARDIAC ARRHYTHMIAS.
P960058|S037|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Special (Immediate Track)||N|05/10/2004|07/23/2004|||APPR|APPROVAL FOR EXPANSION OF THE IN-PROCESS INSPECTION PROCEDURE FOR THE HIRES 90K IMPLANT.  NAMELY, THE PMA SUPPLEMENT PROPOSED TO ADD AN ADDITIONAL VISUAL INSPECTION STEP TO ENSURE WELD INTEGRITY BY USING A MINIMUM OF 80X MAGNIFICATION TO VERIFY THE FOLLOWING: 1) COMPLETE CLOSURE OF THE WELD HOLD, 2) ACCEPTABLE WELD QUALITY, AND 3) ABSENCE OF FOREIGN MATERIAL AT THE WELD SITE.
P010032|S012|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2004|11/09/2004|||APPR|APPROVAL FOR THE GENESIS RC NEUROSTIMULATION SYSTEM, MODEL 3708, AND THE GENESIS RC DUAL (IPG) SYSTEM, MODEL 3744, WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P010031|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC INSYNC ICD MODEL 7272 AND MODEL 9969 APPLICATION SOFTWARE|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|01/28/2004|05/28/2004|||APPR|APPROVAL FOR 1) CHANGES TO THE INVESTIGATIONAL PLAN AND IMPLANT FORMS OF THE POST-APPROVAL STUDY AND 2) THE ADDITION OF THE INSYNC MODEL 7277 WITH MODEL 9983 APPLICATION SOFTWARE TO THE STUDY.
P010031|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROG|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2004|06/23/2004|||APPR|MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROGRAMMER SYSTEM.
P970004|S028|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, LEAD MODELS 3080, 3886, 3889, 3092, 3093, 3966, AND 3095|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2004|05/27/2004|||OK30|CHANGE IN THE SUPPLIER OF RAW MATERIALS USED TO MANUFACTURE THE PRODUCTS.
P810025|S023|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC TM & AMVISC TM PLUS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2004|06/04/2004|||OK30|ADDITION OF A NEW QUALITY CONTROL TEST METHOD FOR THE AMVISC TM AND THE AMVISC TM PLUS.
P860019|S200|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK MONORAIL PTCA CATHETER SYSTEM AND MAVERICK2 MONORAIL PTCA CATHETER SYSTEM|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2004|06/10/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE ALTERNATIVE PARAMETERS FOR LASER WELDING OF THE PORT BOND ON THE MAVERICK AND MAVERICKRAIL PTCA CATHETER SYSTEMS.
P010031|S014|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC II PROTECT MODEL 7295 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2004|06/24/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC), JUNCOS, PUERTO RICO.
P020018|S004|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|H&LB ONE-SHOT DELIVERY SYSTEM FOR USE WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/11/2004|07/15/2004|||APPR|APPROVAL FOR MODIFICATIONS MADE TO THE H&LB ONE-SHOT DELIVERY SYSTEM.
P990023|S003|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/14/2004|05/26/2004|||APPR|APPROVAL TO ADD SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE LABELING.
P880086|S100|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2004|07/21/2004|||APPR|APPROVAL FOR THE MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS.
P950014|S022|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON PRAKTIS|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2004|06/10/2004|||APPR|APPROVAL FOR DESIGN CHANGES TO INCLUDE CHANGING THE CONTACTS ON THE INTERNAL WIRING FROM TIN TO GOLD AND A MODIFICATION TO THE SOFTWARE TO INCLUDE AN ADDITIONAL ALARM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROSTATRON PRAKTIS AND IS INDICATED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH).
P020047|S004|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2004|09/10/2004|||APPR|APPROVAL FOR THE 2.75 MM LINE EXTENSION FOR THE MULTI-LINK VISION CORONARY STENT SYSTEM.  THE DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.75 MM.
P980031|S007|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS PRESCRIPTION INSERTS|LQE|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2004|08/21/2007|||APPR|APPROVAL FOR PACKAGING OPERATIONS FOR THE INTACS PRESCRIPTION INSERTS TO BE TRANSFERRED TO THE SUNNYVALE, CALIFORNIA FACILITY.
P900056|S081|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2004|06/18/2004|||OK30|REDUCTION IN TEST FREQUENCY FOR IN-PROCESS, DESTRUCTIVE PACKAGE TESTING.
P000052|S025|GUIDANT CORP.|26531 YNEZ RD.||TEMECULA|CA|92591|4630|Intravascular radiation delivery system|GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2004|06/10/2004|||OK30|DISCONTINUE THE PREVENTATIVE MAINTENANCE PROGRAM ON THE HEAD AND BASE COMPONENTS OF THE GALILEO SOURCE DELIVERY UNIT (SDU).
P860004|S061|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED IMPLANTABLE INFUSION SYSTEM|LKK|HO|Special (Immediate Track)||N|05/19/2004|06/04/2004|||APPR|APPROVAL FOR A CHANGE TO THE MEDTRONIC MODEL 8840 N'VISION PROGRAMMER TECHNICAL MANUAL TO ADD A PRECAUTION TO IDENTIFY AN ENVIRONMENT IN WHICH THE DEVICE IS NOT CERTIFIED FOR USE.
P980037|S008|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2004|07/15/2004|||APPR|APPROVAL FOR CHANGES TO ANGIOJET XMI CATHETER WHICH INCLUDED: 1) ADDITION OF A PROXIMAL MARKER BAND; 2) CHANGES TO THE PROXIMAL SHAFT; AND 3) CHANGES TO THE STRAIN RELIEF.
P980037|S009|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2004|06/22/2004|||APPR|APPROVAL FOR CHANGES TO THE PUMP SET (ALSO CALLED THE PUMP SET PLUS) WHICH INCLUDED: 1) MODIFICATION TO THE PUMP OUTLET AND INLET FITTINGS; 2) CHANGES TO THE DEPTH OF THE CHECK BALL SEAT AND ELIMINATION OF THE CHECK BALL SPRING; 3) CHANGES TO THE PRIME SENSOR CUP; 4) CHANGES TO THE PISTON HEAD; 5) COLOR CHANGES TO THE LUER; AND 6) CHANGES TO THE PARATUBING ASSEMBLY.
P840001|S073|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 SYNERGY AND SYNERGY VERITREL SPINAL CORD STIMULATION SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2004|06/16/2004|||APPR|APPROVAL FOR A NEW PERMANENTLY IMPLANTED SURGICAL LEAD (MODEL 3999 HINGED 2 X 4 LEAD) TO BE USED WITH MEDTRONICS FULLY IMPLANTABLE NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (P840001) OR THE EXTERNAL RADIO FREQUENCY NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (K934065).
P980037|S010|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET PHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2004|06/22/2004|||APPR|APPROVAL FOR CHANGES TO THE PACKAGING SPECIFICALLY TO THE INNER TRAY AND OUTER POUCH.
P000028|S005|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|AFFINITY ANTERIOR CERVICAL CAGE SYSTEM|MAX|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/2004|06/18/2004|||APPR|APPROVAL FOR AN ALTERNATIVE SURGICAL TECHNIQUE IN WHICH THE REAMING STEP IS REMOVED FROM THE SURGICAL PROCEDURE.
P010015|S013|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC REGISTRY|LWP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|05/19/2004|08/12/2005|||APPR|APPROVAL TO INCORPORATE CRT DEVICES WITH DEFIBRILLATOR CAPABILITIES (CRT-D INTO THE INSYNC REGISTRY.
P790019|S018|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|DEVICE: ABBOTT AXSYM HAVAB-M 2.0|LOL|MI|Special (Immediate Track)||N|05/21/2004|06/16/2004|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
P010049|S011|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/24/2004|07/01/2004|||APPR|APPROVAL TO ADD THROMBIN TO THE HEMOSTATIC PLEDGET.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM AND IS INDICATED FOR " OF T-FOAM FOR EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITES.  THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS.  THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND REDUCES TIME TO ACTUAL HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES."
P030026|S001|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2004|06/14/2004|||OK30|CHANGE IN THE MANUFACTURING EQUIPMENT AND MANUFACTURING PROCESS STEPS ACCEPTANCE CRITERIA ASSOCIATED WITH THIS EQUIPMENT CHANGE.
P000058|S010|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT-LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2004|06/10/2004|||APPR|APPROVAL FOR 1) AN INCREASE IN THE EXPIRATION DATE OF THE 4.2 AND 12 MG VIALED RHBMP-2 COMPONENT OF THE REFERENCED DEVICES FROM 36 TO 48 MONTHS; 2) AN INCREASE IN THE EXPIRATION DATE OF THE COMMERCIAL KIT COMPONENT FROM 24 TO 36 MONTHS; AND 3) THE PROTOCOL TO BE FOLLOWED FOR ALL FUTURE EXPIRATION DATE CHANGES.
P000054|S001|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2004|06/10/2004|||APPR|APPROVAL FOR 1) AN INCREASE IN THE EXPIRATION DATE OF THE 4.2 AND 12 MG VIALED RHBMP-2 COMPONENT OF THE REFERENCED DEVICES FROM 36 TO 48 MONTHS; 2) AN INCREASE IN THE EXPIRATION DATE OF THE COMMERCIAL KIT COMPONENT FROM 24 TO 36 MONTHS; AND 3) THE PROTOCOL TO BE FOLLOWED FOR ALL FUTURE EXPIRATION DATE CHANGES.
P990013|S004|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENSES|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/24/2004|06/23/2004|||APPR|APPROVAL TO MODIFY THE PACKAGE INSERT.
P020025|S005|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP CARDIAC ABLATION SYSTEM|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2004|07/07/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICE CORPORATION, BOTHELL, WASHINGTON.
P920047|S024|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II XP AND BLAZER XP RPM CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/2004|07/27/2004|||APPR|APPROVAL  FOR THE ELIMINATION OF EXCESS WIRING IN THE SUBASSEMBLY OF THE BLAZER II XP AND BLAZER XP RPM CATHETERS.
P020025|S006|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP CARDIAC ABLATION SYSTEM|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/2004|07/27/2004|||APPR|APPROVAL FOR THE ELIMINATION OF EXCESS WIRING IN THE SUBASSEMBLY OF EPT-1000 XP CATHETERS.
P950032|S038|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/2004|06/14/2004|||APPR|APPROVAL TO INTRODUCE A NEW CELL STRAIN INTO THE PRODUCTION OF APLIGRAF (I.E., HDF B700) AND A MODIFICATION OF THE METHODS FOR DETECTING CYTOMEGALOVIRUS (CMV).
P940040|S004|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST|MWA|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2004|06/23/2004|||OK30|CHANGE IN PROCESS POINTS AT WHICH CHEMICAL AND FUNCTIONAL TESTING ARE PERFORMED.
P950037|S038|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/2004|11/10/2004|||APPR|APPROVAL FOR THE ADDITION OF A DRUG COLLAR TO THE PACING LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX ST/JT AND IS INDICATED AS FOLLOWS:  SELOX ST AND SELOX JT STEROID ELUTING LEADS ARE DESIGNED FOR USE WITH IMPLANTABLE PULSE GENERATORS THAT REQUIRE PACING LEADS WITH A BIPOLAR 3.2 MM IS-1 CONNECTOR CONFIGURATION; THEY MAY BE USED WITH SINGLE OR DUAL CHAMBER PACING SYSTEMS.  THE LEADS ARE DESIGNED FOR USE IN PATIENTS FOR WHOM SINGLE OR DUAL CHAMBER PULSE GENERATOR THERAPY IS MEDICALLY INDICATED.  THIS INDICATION FOLLOWS THAT RECOMMENDED IN THE CLASS I DEFINITION OF THE ACC/AHA/NASPE TASK FORCE REPORT, ENTITLED "ACC/AHA/NASPE 2002 GUIDELINE UPDATE FOR IMPLANTATION OF CARDIAC PACEMAKERS AND ANTIARRHYTHMIA DEVICES: A REPORT OF THE AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION TASK FORCE ON PRACTICE GUIDELINES (ACC/AHA/NASPE COMMITTEE ON PACEMAKER IMPLANTATION)" (GREGORATOS ET AL. 2002).
P890064|S015|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 HPV DNA TEST|MAQ|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/2004|07/29/2004|||APPR|APPROVAL FOR REVISIONS TO THE ASSAY'S LABELING PERFORMANCE CHARACTERISTICS SECTION.  THE CHANGE INVOLVES MOVING THE SECTION "RELATIVE FALSE-POSITIVE AND FALSE-NEGATIVE RATE" FROM THE LABELING'S CLINICAL PERFORMANCE SECTION TO THE ANALYTICAL SECTION WITH NARRATIVE REVISIONS.  THE NEW SECTION IS ENTITLED "EXTERNAL STUDY USING CLINICAL SPECIMENS."  A NEW NOTE HAS BEEN ADDED TO THE CURRENT LABELING'S TABLE 10 REFERENCED TO SNIJDERS, PJF, VAN DE BRULE, AJC, AND MEIJER, CJLM, "THE CLINICAL RELEVANCE OF HUMAN PAPILLOMAVIRUS TESTING: RELATIONSHIP BETWEEN ANALYTICAL AND CLINICAL SENSITIVITY".  J PATHOL 2003; 201: 1-6.
P010031|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC SENTRY MODEL 7297 ICD AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.2|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2004|10/26/2004|||APPR|APPROVAL FOR THE INSYNC SENTRY MODEL 7297 ICD AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.2.  THE DEVICE IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A ARS DURATION >= 130MS.
P030025|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/01/2004|08/18/2004|||APPR|APPROVAL FOR EXTENSION OF THE PRODUCT SHELF LIFE.
P960009|S029|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA PARKINSON CONTROL THERAPY|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/01/2004|07/16/2004|||APPR|APPROVAL TO INCORPORATE A POLYETHER URETHANE MATERIAL CHANGE TO THE APPROVED MEDTRONIC MODELS 3387 AND 3389 DBS LEAD KITS, MODELS 7482 AND 7495 EXTENSION KITS FOR DBS, AND MODEL 3550-09 ACCESSORY KIT.
P850035|S030|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR AND EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Normal 180 Day Track||N|06/09/2004|06/03/2005|||APPR|APPROVAL FOR A MODIFIED, SMALLER VERSION OF THE DEVICES.
P790005|S044|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR|LOE|OR|Normal 180 Day Track||N|06/09/2004|06/03/2005|||APPR|APPROVAL FOR A MODIFIED, SMALLER VERSION OF THE DEVICES.
P990001|S015|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON T60 DR AND T20 SR SYSTEMS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2004|07/12/2004|||APPR|APPROVAL FOR THE VITATRON T60 DR AND T20 SR SYSTEMS, WHICH CONSIST OF THE FOLLOWING: 1) THE VITATRON T60 DR SYSTEM INCLUDES THE VITATRON T60 DR MODEL T60A1, THE VSF07/VSF08 VERSION 1.0 APPLICATION SOFTWARE, AND THE VITATRON DESKTOP MODEL VSH03/VSH04 VERSION 2.0 SR1. 2) THE VITATRON T20 SR SYSTEM INCLUDES THE VITATRON T20 SR MODEL T20A1, THE VSF07/VSF08 VERSION 1.0 APPLICATION SOFTWARE, AND THE VITATRON DESKTOP MODEL VSH03/VSH04 VERSION 2.0 SR1.  NOTE: THE ABOVE REFERENCED APPLICATION SOFTWARE AND DESKTOP WILL BE DISTRIBUTED ON THE MODEL VSE03/VSE04 VERSION 2.0 CD-ROM.
P020040|S001|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 8|POB 58165|TEL-AVIV||61581||STENT, CORONARY|NIRFLEX PREMOUNTED CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2004|07/02/2004|||OK30|MODIFICATION TO THE STENT ELECTRO-POLISHING PROCESS.
P030017|S001|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2004|06/28/2004|||OK30|ADDITION OF A LARGER STERILIZATION CHAMBER.
P860008|S018|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR|LPA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/04/2004|08/27/2004|||APPR|APPROVAL FOR THE INTERCHANGEABILITY OF EXISTING APPROVED PRODUCTS.  THOSE PRODUCTS ARE EXTERNAL PULSE GENERATORS (MODELS 2A, 7A, AND 7B) AND ESOPHAGEAL CATHETER SYSTEMS (MODELS 205, 210, 210S, 1600, 500 SERIES, AND TAPSUL.)
P840002|S012|CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR|LPA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/04/2004|08/27/2004|||APPR|APPROVAL FOR THE INTERCHANGEABILITY OF EXISTING APPROVED PRODUCTS.  THOSE PRODUCTS ARE EXTERNAL PULSE GENERATORS (MODELS 2A, 7A, AND 7B) AND ESOPHAGEAL CATHETER SYSTEMS (MODELS 205, 210, 210S, 1600, 500 SERIES, AND TAPSUL.)
P980044|S002|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/07/2004|09/10/2004|||APPR|APPROVAL FOR ADDITION OF A PLASTIC SYRING BARREL WITH LUER LOCK, IN ADDITION TO THE EXISTING GLASS SYRINGE BARREL PRODUCT.
P950029|S020|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|SYMPHONY AND ELA RHAPSODY PACEMAKERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2004|07/15/2004|||APPR|APPROVAL FOR UNCOATED VERSIONS OF THE SYMPHONY AND ELA RHAPSODY PACEMAKERS.
P010014|S001|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/04/2004|03/23/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P030005|S002|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|permanent pacemaker Electrode|CONTAK RENEWAL TR (MODEL H120 AND H125)|DTB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/2004|06/28/2004|||APPR|APPROVAL FOR MINOR LABELING CHANGES TO THE CRT-P DEVICE.
P010019|S003|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/2004|09/27/2004|||APPR|APPROVAL FOR 1) A MODIFICATION TO THE LOTRAFILCON A MATERIAL TO MARKET LOTRAFILCON B CONTACT LENSES WITH AN INDICATION FOR UP TO 6 NIGHTS OF EXTENDED WEAR; 2) INCORPORATION OF A LIGHT BLUE HANDLING TINT, COPPER PHTHALOCYANINE, TO BOTH THE LOTRAFILCON A AND LOTRAFILCON B LENS MATERIALS; AND 3) A LABELING CHANGE FOR LOTRAFILCON A LENSES TO ALLOW FOR USE WITH ENZYMATIC CLEANERS.  THE LOTRAFILCON B LENS WILL BE MARKETED UNDER THE TRADE NAME O2 OPTIX (LOTRAFILCON B) SOFT CONTACT LENSES FOR EXTENDED WEAR AND IS INDICATED FOR THE FOLLOWING: O2 OPTIX (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO APPROXIMATELY 1.50 DIOPTERS (D) OF ASTIGMATISM THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  O2 OPTIX TORIC (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO 6.00 D OR LESS OF ASTIGMATISM.  O2 OPTIX PROGRESSIVE (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) AND/OR PRESBYOPIA IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY REQUIRE A READING ADDITION OF +3.00 D OR LESS AND WHO MAY HAVE UP TO APPROXIMATELY 1.50 D OF ASTIGMATISM.  O2 OPTIX PROGRESSIVE TORIC (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA, ASTIGMATISM, AND PRESBYOPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENSES MAY BE WORN BY PERSONS WHO HAVE 0.75 TO 2.75 D OF REFRACTIVE AND/OR CORNEAL ASTIGMATISM.  THE LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR FOR UP TO 6 NIGHTS OF CONTINUOUS WEAR WITH REMOVAL FOR DISPOSABLE, OR CLEANING AND DISINFECTION (CHEMICAL, NOT HEAT) PRIOR TO REINSERTION, AS RECOMMENDED BY THE EYE CARE PROF.
P030017|S002|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2004|10/01/2004|||APPR|APPROVAL FOR THE MODEL SC-1110 IMPLANTED PULSE GENERATOR (IPG), THE MODEL SC-5110 EXTERNAL TRIAL STIMULATOR (ETS), THE MODEL SC-5210 REMOTE CONTROL AND UPDATES TO THE CLINICIAN PROGRAMMER.
P980031|S008|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS PRESCRIPTION INSERTS|LQE|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2004|07/08/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADDITION TECHNOLOGY, INC., SUNNYVALE, CALIFORNIA.
P990037|S021|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/15/2004|07/14/2004|||APPR|APPROVAL FOR MODIFYING THE PRESSURE RELIEF VALVE COMPONENT ON THE CATHETER AND REPLACING THE MIXING 20 GAUGE NEEDLE SYRINGE WITH A NEEDLELESS NON-CORING VIAL ACCESS DEVICE.
P830060|S055|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD ADAPTERS MODEL 6833, 6836, 6931|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2004|07/06/2004|||OK30|CHANGE IN THE SUPPLIER FOR THE MOLD RELEASE, A CHANGE IN THE TYPE OF LUBRICANT, AND A CHANGE IN THE PROCESS OF APPLYING THE LUBRICANT.
P910073|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 6931|LWS|CV|30-Day Notice||N|06/14/2004|07/06/2004|||OK30|CHANGE IN THE SUPPLIER FOR THE MOLD RELEASE, A CHANGE IN THE TYPE OF LUBRICANT, AND A CHANGE IN THE PROCESS OF APPLYING THE LUBRICANT.
P970027|S001|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT AXSYM ANTI-HCV|MZO|MI|Special (Immediate Track)||N|06/14/2004|06/30/2004|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
P980023|S018|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|KENTROX RV STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/14/2004|07/27/2004|||APPR|APPROVAL FOR ADDITION OF THE STEROID COLLAR TO THE DISTAL END OF THE LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME KENTROX SL STEROID AND KENTROX RV STEROID AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD.
P900060|S029|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2004|07/02/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE STERILIZATION PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN A BIOLOGICAL INDICATOR.
P990037|S022|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT PRO SEALING DEVICE MODEL 1010|MGB|CV|Normal 180 Day Track No User Fee|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2004|07/09/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS CORP., ISOMEDIX SERVICES, MINNEAPOLIS, MINNESOTA.
P980037|S011|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE|MCX|CV|Special (Immediate Track)||N|06/16/2004|06/30/2004|||APPR|APPROVAL FOR THE ADDITION OF A BOXED WARNING REGARDING USE IN PULMONARY VASCULATURE TO ALL POSSIS ANGIOJET CATHETER INSTRUCTION FOR USE DOCUMENTS.
P020023|S007|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2004|07/07/2004|||OK30|CHANGE IN THE CLEANING PROCESS.
P000046|S010|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II, SHELLGEL, COEASE SODIUM HYALURONATE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2004|07/16/2004|||OK30|CHANGE IN PROCEDURE FOR THE QUALITY CONTROL TEST METHOD (OWL MONKEY TEST) FOR STAARVISC II, SHELLGEL AND COEASE.
P030019|S005|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MODECULAR WEIGHT HYALURNAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2004|07/14/2004|||OK30|CHANGE IN A QUALITY CONTROL METHOD FOR ORTHOVISC, HIGH MOLECULAR WEIGHT HYALURONATE.
P000029|S008|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2004|07/09/2004|||OK30|CHANGE FROM WASHING MANUFACTURING EQUIPMENT MANUALLY TO USE OF A DISHWASHER.  IN ADDITION, THE SUPPLEMENT COVERS THE ELIMINATION OF THE USE OF DETERGENT TO USE OF WATER ONLY.
P980050|S016|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL 9974|LWS|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/18/2004|08/31/2004|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P010012|S029|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK RENEWAL AND CONTAK RENEWAL 3|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/21/2004|08/06/2004|||APPR|APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 2.4.
P030005|S003|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|permanent pacemaker Electrode|CONTAK RENEWAL TR|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/21/2004|08/06/2004|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE APPLICATION MODEL 2865 VERSION 1.9.
P020004|S007|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/17/2004|10/20/2004|||APPR|APPROVAL FOR THE FORMAT TO BE USED FOR A CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIAN USERS AT LEAST ANNUALLY.
P840064|S026|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/2004|03/23/2005|||APPR|APPROVAL FOR THE DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.
P020023|S008|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/22/2004|07/23/2004|||APPR|APPROVAL FOR THE PRODUCT BOX LABEL TO SAY "SYRINGE CONTENTS ARE STERILE".
P030032|S001|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|HYLAFORM PLUS (HYLAN B GEL)|LMH|SU|Panel Track|Change Design/Components/Specifications/Material|N|06/22/2004|10/13/2004|04M-0467|10/27/2004|APPR|APPROVAL FOR THE HYLAFORM PLUS.  THE DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
P010038|S008|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/2004|09/01/2004|||APPR|APPROVAL FOR THE USE OF THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM WITH THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM AND IS INDICATED FOR:  THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P810025|S024|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC & AMVISC PLUS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2004|07/16/2004|||OK30|ELIMINATION OF THE OWL MONKEY TEST FOR INFLAMMATORY POTENTIAL OF BULK AND FINISHED PRODUCT FORMULATION OF AMVISC & AMVISC PLUS.
P020022|S001|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2004|12/14/2004|||APPR|APPROVAL FOR CHANGES TO BULK AND RAW MANUFACTURING PROCEDURES.
P010012|S030|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FINISHING WIRE UNIVERSAL , MODEL NUMBERS 6002,6003,6004,6005,6007|NIK|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/2004|07/21/2004|||APPR|APPROVAL FOR ADDING INSTRUCTIONS IN THE LABELING TO CONTINUE FLUOROSCOPY DURING REMOVAL OF THE GUIDING CATHETER.
P930031|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS AND VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice||N|06/25/2004|07/22/2004|||OK30|REDUCTION IN BOND CURE TIMES FOR TWO PROCESSING STEPS USED IN THE MANUFACTURE OF THE STENT DELIVERY CATHETER FOR THE ABOVE-STATED DEVICES.
P980033|S011|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS AND VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2004|07/22/2004|||OK30|REDUCTION IN BOND CURE TIMES FOR TWO PROCESSING STEPS USED IN THE MANUFACTURE OF THE STENT DELIVERY CATHETER FOR THE ABOVE-STATED DEVICES.
P970058|S020|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/2004|02/17/2005|||APPR|APPROVAL FOR IMPROVEMENTS IN THE CAD DETECTION ALGORITHM AND THE INTRODUCTION OF MORE CHOICE IN OPERATING POINTS FOR BOTH ANALOG AND DIGITAL IMAGES.
P980053|S007|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE EXP|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/2004|10/27/2004|||APPR|APPROVAL FOR 1 ML SYRINGES WITH SYNTHETIC RUBBER STOPPERS.  THESE SYRINGES ARE INTENDED TO STORE DURASPHERE EXP.
P030002|S001|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMMODATING INTRAOCULAR LENS (IOL)|NAA|OP|Real-Time Process||N|06/28/2004|08/16/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE PHYSICIAN'S LABELING.
P000018|S041|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA - CATH SYSTEM|MOU|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2004|10/04/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN NORCROSS, GEORGIA, TO PROCESS RADIATION SOURCE TRAINS FOR THE BETA-CATH SYSTEM.
P010013|S008|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2004|08/13/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE RF CONTROLLER, MODEL 09.
P030054|S001|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST. JUDE MEDICAL EPIC HF DEFIBRILLATOR MODEL V-337, ST. JUDE MEDICAL ATLAS+ HF DEFIBRILLATOR MODEL V-343|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2004|11/17/2004|||APPR|APPROVAL FOR THE ADDITION OF A PROGRAMMABLE INTERVENTRICULAR PACE DELAY FEATURE TO THE CURRENTLY MARKET-APPROVED CRT-D DEVICES.
P030019|S006|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC SODIUM HYALURONATE|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2004|12/28/2004|||APPR|APPROVAL TO MODIFY THE LABELING TO INCLUDE SAFETY INFORMATION CONCERNING A REPEAT COURSE OF TREATMENT OF ORTHOVISC.
P030025|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2004|03/31/2005|||APPR|APPROVAL TO USE STERIS ISOMEDIX (FORMERLY COSMED OF RHODE ISLAND) AS AN ALTERNATE STERILIZATION SITE FOR DEVICES MANUFACTURED AT GALWAY, IRELAND.
P970015|S028|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|INTER FIX THREADED FUSION DEVICE|MAX|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2004|07/19/2004|||OK30|CHANGE OF STERILIZATION VALIDATION METHODS FOR THE INTER FIX THREADED FUSION DEVICE.
P980041|S005|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2004|07/15/2004|||OK30|CHANGES IN THE MANUFACTURING PROCESS TO THE REAGENT PACK INTERMEDIATE COMPONENTS FOR THE ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER.
P970051|S028|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2004|03/01/2005|||APPR|APPROVAL FOR A NEW RECEIVER/STIMULATOR COMPONENT (CI24RE), A NEW SPEECH PROCESSOR (SP12), THE PIF4 PROGRAMMING INTERFACE, THE CS14 PROGRAMMING SOFTWARE, AND UPGRADED NEURAL RESPONSE TELEMETRY SOFTWARE (EPS5).
P960043|S054|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE A-T AND PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE (SMC) SYSTEMS|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2004|07/15/2004|||APPR|APPROVAL FOR MODIFIED SHEATH AND FOOT ASSEMBLIES ON THE PERCLOSE A-T AND PROGLIDE DEVICES AND THE ADDITION OF A SUTURE CUTTER ON THE PERCLOSE A-T DEVICE.
P010062|S001|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT|NUU|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/2004|08/02/2004|||APPR|APPROVAL FOR THE PROTOCOL TO BE USED TO ADD CONTACT LENS FINISHING LABORATORIES TO MANUFACTURE THE SUBJECT DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT AND IS INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES.  THE LENSES ARE INDICATED FOR OVERNIGHT WEAR FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.5 DIOPTERS.  THE LENSES MAY ONLY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM.  NOTE: TO MAINTAIN THE ORTHOKERATOLOGY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE.  FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.
P890023|S015|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|HYDROGENICS 60 (OCUFILICON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track No User Fee|Express GMP Supplement|N|07/02/2004|08/02/2004|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT OCULAR SCIENCES, INC., ALBUQUERQUE NEW MEXICO.
P970021|S011|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|CATHETER, BALLOON, TRANSCERVICAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MKN|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/07/2004|08/23/2004|||APPR|APPROVAL FOR LABELING CHANGES FOR THE THERMACHOICE III.
P000014|S008|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS  REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2004|07/16/2004|||OK30|REMOVAL OF THE IN-PROCESS TESTING OF THE FORMULATED CALIBRATOR BEFORE DISPENSING INTO VIALS SINCE THE TEST IS REPEATED DURING THE QUALITY CONTROL RELEASE OF THE ANTI-HBS REAGENT PACK AND CALIBRATORS.
P010021|S002|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2004|07/16/2004|||OK30|REMOVAL OF THE IN-PROCESS TESTING OF THE FORMULATED CALIBRATOR BEFORE DISPENSING INTO VIALS SINCE THE TEST IS REPEATED DURING THE QUALITY CONTROL RELEASE OF THE ANTI-HCV REAGENT PACK AND CALIBRATORS.
P980016|S043|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/07/2004|08/18/2004|||APPR|APPROVAL FOR A RAMWARE UPDATE TO THE MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS.
P960043|S055|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE 6 FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/2004|08/30/2004|||APPR|APPROVAL FOR REVISED INSTRUCTIONS FOR USE INTENDED TO ENHANCE THE SAFE USE OF THE DEVICES.
P950015|S010|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|THE HEART LASER CO2 TMR SYSTEM|MNO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/06/2004|03/21/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE ELECTRONIC PRE-IGNITION SYSTEM USED BY THE LASER MEDICAL DEVICE.
P010013|S009|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/2004|08/02/2004|||APPR|APPROVAL FOR LABELING CHANGES.
P020023|S009|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/2004|08/06/2004|||APPR|APPROVAL FOR INCREASING THE EXPIRATION DATING FOR RESTYLANE FROM 24 MONTHS TO 36 MONTHS.
P960011|S009|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/2004|01/27/2005|||APPR|APPROVAL FOR A CHANGE IN MANUFACTURING SITE TO THE BIO-TECHNOLOGY GENERAL, LTD. FACILITY IN BE'ER TUVIA, ISRAEL, AND FOR A CHANGE IN THE SPECIFICATIONS FOR THE ACTIVE PHARMACEUTICAL PRODUCT IN BIOLON.
P000029|S009|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2004|07/30/2004|||OK30|CHANGE IN A TEST SITE.
P020003|S003|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Prosthesis, testicular|SALINE-FILLED TESTICULAR PROSTHESIS|FAF|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2004|07/28/2004|||APPR|APPROVAL TO ADD A CAUTIONARY STATEMENT TO THE OUTER PACKAGING SPECIFYING THAT THE DEVICE SHOULD BE FILLED WITH SALINE PRIOR TO IMPLANTATION.
P890057|S017|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR|LSZ|AN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2004|02/25/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIRD PRODUCTS CORPORATION, PALM SPRINGS, CALIFORNIA.
P030009|S002|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/2004|04/21/2006|||APPR|APPROVAL FOR THE MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND THE MICRO-DRIVER MX2 CORONARY STENT SYSTEM.  THE SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS WITH REFERENCE VESSEL DIAMETERS OF 2.25-2.75 MM AND <=21 MM IN LENGTH.  OUTCOME BEYOND 270 DAYS FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P970040|S003|GE LUNAR CORP.|726 HEARTLAND TRAIL||MADISON|WI|53717||Bone sonometer|ACHILLES EXPRESS ULTRASONOMETER|MUA|RA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|07/15/2004|07/30/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GE MEDICAL SYSTEMS CHINA CO., LTD., JIANSGU, P.R. CHINA.
P020030|S001|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/2004|11/22/2004|||APPR|APPROVAL FOR THE INTRODUCTION OF THE EASYTURN DEPLOYMENT MECHANISM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASYTURN AND IS INDICTED FOR USE WITH AN IMPLANTABLE PACEMAKER.  THEY ARE INTENDED FOR PERMANENT  PACING AND SENSING OF THE ATRIUM.
P960030|S011|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ISOFLEX S PERMANENT PACING LEAD MODELS PASSIVE PLUS DX|DTB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2004|06/29/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, BS, CAGUAS, PUERTO RICO 00725.
P010021|S003|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2004|07/30/2004|||OK30|CHANGE IN THE MANUFACTURING EQUIPMENT AND MANUFACTURING PROCESS STEPS ACCEPTANCE CRITERIA ASSOCIATED WITH THIS EQUIPMENT CHANGE.  THE PROPOSED CHANGES AFFECT THE MANUFACTURING OF VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK.
P010049|S012|SUB-Q, INC.|1062-D CALLE NEGOCIO||SAN CLEMENTE|CA|92673||Device, hemostasis, vascular|SURESTAT ARTERIAL CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/19/2004|08/31/2004|||APPR|APPROVAL TO ADD A POLYSACCHARIDE (CHITOSAN) TO THE HEMOSTATIC PLEDGET FORMULATION AND REQUESTED TO RENAME THE DEVICE FROM THE QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM TO THE SURESTAT ARTERIAL CLOSURE SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURESTAT ARTERIAL CLOSURE SYSTEM AND IS INDICATED FOR "DELIVERY OF T-FOAM FOR EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITES.  THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS.  THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND REDUCES TIME TO ACTUAL HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES."
P020006|S005|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MAILSTOP: MB-16|MARLBOROUGH|MA|01752||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|ENTERYX PROCEDURE KIT, MODEL M000572600|LNM|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/2004|08/20/2004|||APPR|APPROVAL FOR CHANGES TO THE PHYSICIAN AND PATIENT LABELING WHICH ENHANCES INFORMATION REGARDING ADVERSE EVENTS.
P960009|S030|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PARKINSON'S CONTROL THERAPY|MHY|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|07/20/2004|01/14/2005|||APPR|APPROVAL FOR A REVISED POST-APPROVAL STUDY FOR THE DEVICE.
P030035|S001|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER II BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2004|08/16/2004|||APPR|APPROVAL FOR THE FRONTIER II MODEL 5586 BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE.
P960040|S045|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2004|08/17/2004|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO EXPAND THE GUIDANT CLONMEL, IRELAND PLANT BY ADDING HYBRID FABRICATION CAPABILITY TO THE VITALITY FAMILY OF DEVICES.
P780012|S014|Abbott Laboratories|100 ABBOTT PARK ROAD|D-049C/AP6C-2|ABBOTT PARK|IL|60064||Hepatitis a test (antibody and igm antibody)|AXSYM HAVAB 2.0|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2004|07/30/2004|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
P010017|S005|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Full field digital,system,x-ray,mammographic|SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/2004|03/07/2005|||APPR|APPROVAL FOR ADDITION OF AUTOMATIC EXPOSURE SYSTEM, AND RELATED CHANGES IN OPERATOR'S MANUAL AND QC TEST AND QC MANUAL UNDER MQSA.
P870072|S029|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC PVAD SYSTEM AND TLC-II PORTABLE VAD DRIVER|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|02/23/2004|09/13/2004|||APPR|APPROVAL FOR THE POST APPROVAL STUDY HOME-DISCHARGE REGISTRY PROTOCOL.
P980016|S044|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MAXIMO VR MODELS 7232B AND 7232 IMPLANTABLE CARDIAC DEFIBRILLATORS (ICDS)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2004|08/25/2004|||APPR|APPROVAL FOR THE ADDITION OF B AND E CONNECTORS TO THE MAXIMO VR MODEL 7232.
P030032|S002|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|CAPTIQUE INJECTABLE GEL|LMH|SU|Normal 180 Day Track||N|07/28/2004|11/12/2004|||APPR|APPROVAL FOR A NEW SOURCE OF HYALURONIC ACID OBTAINED FROM BACTERIAL FERMENTATION.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CAPTIQUE AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
P860057|S023|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX|DYE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/27/2004|04/07/2005|||APPR|APPROVAL FOR EXTENSION OF THE SHELF LIFE FROM ONE TO TWO YEARS.
P960058|S038|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2004|08/24/2004|||APPR|APPROVAL FOR AN INTERIM DESIGN CHANGE FOR THE AURIA POWERPAK ACCESSORY TO THE HIRESOLUTION BIONIC EAR SYSTEM.  SPECIFICALLY, YOU PROPOSE THE ADDITION OF AN INSULATING WASHER TO THE AURIA POWERPAK ASSEMBLY WHILE YOU DEVELOP A FINAL DESIGN SOLUTION FOR THE RECENTLY DISCOVERED SAFETY ISSUE ASSOCIATED WITH THIS DEVICE.  WE NOTE THAT YOU AGREE TO DESIGN, TEST, MANUFACTURE, AND DISTRIBUTE THE REVISED AURIA POWERPAK MODEL WITH THE FINAL DESIGN SOLUTION WITHIN SIX MONTHS OF THE DATE OF THIS LETTER.  WE FURTHER NOTE THAT YOU AGREE TO SUBMIT A SUPPLEMENT TO FDA FOR THE PROPOSED FINAL DESIGN ONCE THE DESIGN AND TEST ACTIVITIES HAVE BEEN COMPLETE AND WILL NOT DISTRIBUTE THE REVISED AURIA POWERPAK WITHOUT FDA APPROVAL.
P010068|S004|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER|OAD|CV|Real-Time Process|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2004|09/10/2004|||APPR|APPROVAL FOR AN ALTERNATIVE STERILIZATION METHOD (I.E., EO EXPRESS FOR BIOLOGICAL INDICATOR RELEASE) FOR THE NAVISTAR DS 8MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER.
P030006|S002|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|CELSION PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/2004|09/17/2004|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS INCLUDING ADJUSTMENT OF TOLERANCE LIMITS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROLIEVE THERMODILATION SYSTEM (PROLIEVE).  PROLIEVE IS A TRANSURETHRAL MICROWAVE THERAPY DEVICE THAT PROVIDES A NON-SURGICAL, MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF SYMPTOMATIC BPH IN MEN WITH A PROSTATE SIZE OF 20 TO 80 GRAMS, A PROSTATIC URETHRA LENGTH OF 1.2 TO 5.5 CM AND IN WHOM DRUG THERAPY (E.G., PROSCAR) IS TYPICALLY INDICATED.
P910007|S011|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE|ABBOTT AXSYM TOTAL PSA ASSAY|JJE|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/29/2004|09/27/2004|||APPR|APPROVAL OF THE FOLLOWING MODIFICATIONS TO THE ABBOTT AXSYM TOTAL PSA ASSAY: 1) CHANGE THE FUNCTIONAL SENSITIVITY CLAIM TO 0.06 NG/ML 2) ADDITION OF FLOMAX TO THE ANALYTICAL SPECIFICITY SECTION OF THE PACKAGE INSERT 3) MINOR LABELING CHANGES TO THE PACKAGE INSERT FOR THE PURPOSE OF CLARIFICATION, UPDATES AND CONFORMATION TO REQUIREMENTS OF THE EUROPEAN COMMUNITY DIRECTIVES.  THE AXSYM  TOTAL PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPSIN) IN HUMAN SERUM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER.  PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
P980041|S006|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2004|08/04/2004|||APPR|APPROVAL OF THE ADDITION OF AN ASSAY PROTOCOL FILE TO THE ASSAY SOFTWARE OF THE ACCESS AFP REAGENT FOR ON-BOARD SYSTEM AUTO-DILUTION OF HUMAN SERUM AND AMNIOTIC FLUID SAMPLES FOR ALL ACCESS IMMUNOASSAY ANLAYZERS (ACCESS, ACCESS 2, SYNCHRON LXI 725 AND UNICEL DXI 800).  THE ACCESS AFP ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE USE WITH THE ACCESS IMMUNOASSAY SYSTEMS FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN:  1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER.  2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD).  TEST RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD.  THE ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY.
P000028|S006|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|AFFINITY ANTERIOR CERVICAL CAGE SYSTEM|MAX|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2004|08/24/2004|||OK30|CHANGE OF STERILIZATION VALIDATION METHODS FOR THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM.
P010055|S001|PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/2004|07/07/2005|||APPR|APPROVAL FOR TECHNOLOGICAL MODIFICATIONS TO THE CORETHERM SYSTEM TO COMPLY WITH THE NEW EDITION OF IEC 6061-1-2 "MEDICAL ELECTRICAL EQUIPMENT - PART1: GENERAL REQUIREMENTS FOR SAFETY; ELECTROMAGNETIC COMPATIBILITY REQUIREMENTS AND TESTS" (2ND EDITION, 2001).
P000054|S002|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/02/2004|08/09/2004|||APPR|APPROVAL FOR EXPANSION OF THE UPPER END OF THE STORAGE TEMPERATURE LIMIT FOR THE INFUSE BONE GRAFT COMPONENT OF THE DEVICE FROM 25 DEGREES C TO 30 DEGREES C.  THE DEVICE IS INDICATED FOR TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT.  INFUSE BONE GRAFT MUST BE APPLIED WITHIN 14 DAYS AFTER THE INITIAL FRACTURE.  PROSPECTIVE PATIENTS SHOULD BE SKELETALLY MATURE.
P960030|S012|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS|DTB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/2004|04/27/2005|||APPR|APPROVAL FOR THE ADDITION OF A POLYURETHANE INSULATOR.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ISOFLEX P 1644T AND ISOFLEX P 1648T LEADS AND ARE INDICATED FOR USE IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM (MODEL 1644T) OR VENTRICLE (MODEL 1648T).
P990020|S017|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/2004|10/28/2004|||APPR|APPROVAL FOR MODIFICATIONS MADE TO THE ANEURX DELIVERY SYSTEM, A CHANGE IN STERILIZATION METHOD, AND CHANGES TO THE INSTRUCTIONS FOR USE.
P980007|S005|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ABBOTT AXSYM FREE PSA ASSAY|MTG|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/2004|09/10/2004|||APPR|APPROVAL FOR THE ADDITION OF FLOMAX TO THE ANALYTICAL SPECIFICITY SECTION OF THE PACKAGE INSERT AND MINOR LABELING CHANGES TO THE ABBOTT AXSYM FREE PSA ASSAY FOR THE PURPOSE OF CLARIFICATION, UPDATES AND CONFORMATION TO REQUIREMENTS OF THE EUROPEAN COMMUNITY DIRECTIVES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME AXSYM FREE PSA ASSAY AND IS INDICATED AS FOLLOWS:  THE AXSYM FREE PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM.  THE AXSYM FREE PSA ASSAY IS INTENDED TO BE USED IN PSA VALUES BETWEEN 4 AND 10 NG/ML AND NON-SUSPICIOUS DRE TO DETERMINE THE % FREE PSA VALUE.  THE AXSYM % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE.
P990075|S015|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS|FWM|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2004|01/20/2006|||APPR|APPROVAL FOR AN OPTIONAL MANUFACTURING METHOD FOR THE ROUND SHELLS.  MORE SPECIFICALLY, APPROVAL FOR A SPRAY-FORMING PROCESS FOR SHELLS USED FOR ROUND STYLES 1600, 2000, 2600, 3000, 1400 AND 2400.
P920014|S024|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/2004|02/02/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXISTING SYSTEM MONITOR DESIGN, WHICH IS USED WITH THE HEARTMATE XVE AND VE DEVICES.
P960043|S056|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|GATED SUTURE TRIMMER ACCESSORY|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2004|09/10/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE GATED SUTURE TRIMMER ACCESSORY, SPECIFICALLY, OVERMOLDING THE TIP-SHEATH PROFILE AND INCREASING THE DIAMETER OF THE SHEATH TO MATCH THE NEW TIP DIAMETERS.
P950037|S039|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|PROTOS DR/CLS AND PROTOS VR/CLS|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/09/2004|06/22/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING.
P950039|S012|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/10/2004|08/05/2005|||APPR|APPROVAL FOR AN ADDITION TO THE CURRENT LABELING, WITH REGARD TO THE EVALUATION OF GLANDULAR ABNORMALITIES USING THE THINPREP 2000 SYSTEM.
P990027|S007|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION|LZS|OP|Normal 180 Day Track||N|09/10/2004|03/15/2006|||APPR|APPROVAL FOR: 1) AN INCREASE IN THE LASER PULSE REPETITION FREQUENCY FROM THE CURRENT 50 HZ TO 100 HZ; 2)REPLACEMENT OF THE CERATUBE MIDI V.4.1 LASER WITH THE CERATUBE MIDI V.5.2 LASER; 3) SOFTWARE REVISIONS TO ACCOMMODATE THE NEW LASER AND PULSE RATE;  4) LABELING CHANGES TO DOCUMENT THESE MODIFICATIONS.
P000049|S015|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD|MLV|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/2004|09/13/2004|||APPR|APPROVAL TO MODIFY THE PATIENT INFORMATION CARD TO INCLUDE A REVISED MRI COMPATIBILITY STATEMENT THAT SPECIFIES THAT THE COMPATIBILITY TESTING WAS PERFORMED WITH A 1.5 TESLA MAGNETIC FIELD.
P010013|S010|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/2004|09/09/2004|||APPR|APPROVAL FOR LABELING CHANGES.
P030035|S002|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM|NKE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/13/2004|01/14/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR YOUR DEVICE.
P030054|S002|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST JUDE MEDICAL EPIC HF MODEL V-338 AND ATLAS + HF MODEL V-340 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/16/2004|01/14/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR YOUR DEVICE.
P910073|S047|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD ADAPTERS MODEL NUMBER 6024|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2004|09/13/2004|||OK30|CHANGE IN THE SUPPLIER THAT PROVIDES THE MOLD RELEASE COATING THAT IS USED ON THE SLEEVE OF THE LEAD ADAPTERS TO PREVENT THE BONDING OF THE SILICON SLEEVE TO ITSELF.
P030017|S003|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM LEAD ASSEMBLY|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/17/2004|01/19/2005|||APPR|APPROVAL FOR CHANGES TO THE LEAD ASSEMBLY.
P010012|S031|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 RF/HE CRT-D,CONSULT PROGRAMMER SOFT WARE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/2004|02/09/2005|||APPR|APPROVAL FOR THE ADDITION OF WANDLESS TELEMETRY TO YOUR CURRENTLY MARKET-APPROVED CRT-D DEVICES THAT WILL ALLOW COMMUNICATION WITH THE PROGRAMMER AT AN INCREASED DISTANCE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTAK RENEWAL 3 RF AND IS INDICATED FOR THE FOLLOWING:  THE CONTAK RENEWAL 3 RF CRT-D IS INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS.
P980049|S016|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2004|11/17/2004|||APPR|APPROVAL FOR CHANGES TO THE ALTO 2 ICD LOW-POWER MODULE AND FINAL DEVICE ASSEMBLY PROCESS PERFORMED AT ELA MEDICAL, S.A.
P020033|S001|INDEPENDENCE TECHNOLOGY, L.L.C.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Wheelchair, stair climbing|INDEPENDENCE IBOT 3000 MOBILITY SYSTEM|IMK|PM|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2004|08/27/2004|||APPR|APPROVAL FOR A CHANGE TO THE DESIGN OF THE WHEEL CLUSTER HOUSING ACCESS PORT CAP/COVER AS WELL AS LABELING CHANGES TO THE USER MANUAL THAT ADD A WARNING, A CAUTION, AND ASSOCIATED INSTRUCTIONS REGARDING DRIVING THROUGH DEBRIS.
P890023|S016|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED  WEAR|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/2004|09/24/2004|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO INCORPORATE THE ASPHERIC VERSION OF THE LENS; A MINOR EDGE CONFIGURATION CHANGE; AND MINOR LABELING CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR AND IS INDICATED AS FOLLOWS:  HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THEY ARE ALSO INDICATED FOR EXTENDED WEAR UP TO 7 DAYS/6NIGHTS.  THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENSES FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WEAR.  WHEN PRESCRIBED FOR FREQUENT REPLACEMENT/ PLANNED REPLACEMENT, THE LENSES MAY BE DISINFECTED USING A CHEMICAL OR HYDROGEN PEROXIDE DISINFECTING SYSTEM.  THE DEVICE HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
P960052|S009|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND TOPICAL SKIN ADHESIVE|MPN|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2004|09/24/2004|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY AND TO ANOTHER KNOWN METHOD OF STERILIZATION LOCATED AT STERIGENICS (FORMERLY IBA/GRIFFITH), CHARLOTTE, NORTH CAROLINA.
P970051|S029|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/17/2004|01/19/2005|||APPR|APPROVAL FOR A NEW INJECTION-MOULDED CERAMIC FEEDTHROUGH COMPONENT AND ITS RELATED MANUFACTURING PROCESSES.
P930038|S040|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 AND 610131|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2004|09/13/2004|||APPR|APPROVAL FOR A NEW 9 HOLE, HOUR-GLASS SHAPE COLLAGEN SPONGE AND A COATED SUTURE WITH MINOR CHANGES TO THE CARRIER TUBE TO INCORPORATE THE COLLAGEN SPONGE CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 (6 FR.) AND 610131 (8 FR.).
P900033|S012|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2004|09/17/2004|||OK30|EXTENSION OF THE ALLOWED HOLDING TIME FOR ONE OF THE MANUFACTURING PROCESSES.
P890003|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847...|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2004|09/15/2004|||APPR|APPROVAL TO UPDATE THE LONGEVITY PROJECTIONS FOR THE MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847 SOFTWARE FOR 7968-I THERA DR DEVICE AND MODEL 9980 SOFTWARE FOR THE INSYNC 8040 DEVICE.
P010015|S014|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC 8040 DEVICES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2004|09/15/2004|||APPR|APPROVAL TO UPDATE THE LONGEVITY PROJECTIONS FOR THE MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847 SOFTWARE FOR 7968-I THERA DR DEVICE AND MODEL 9980 SOFTWARE FOR THE INSYNC 8040 DEVICE.
P020023|S010|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice||N|08/24/2004|09/17/2004|||OK30|CHANGE OF LOCATION FOR A MANUFACTURING PROCESS.
P930016|S019|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/07/2004|02/18/2005|||APPR|APPROVAL FOR THE ADDITION OF AN IRIS IDENTIFICATION AND REGISTRATION SYSTEM AND AN OZONE  SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STAR S4-IR EXCIMER LASER SYSTEM.
P980022|S011|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Panel Track||Y|08/20/2004|07/18/2005|05M-0454|11/15/2005|APPR|APPROVAL FOR THE GUARDIAN RT.  THE DEVICE IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN IN ADULTS (AGES 18 AND OLDER) WITH DIABETES MELLITUS FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT.  IT ALERTS IF A GLUCOSE LEVEL FALLS BELOW OR RISES ABOVE PRESET VALUES.  VALUES ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGER STICK MAY BE REQUIRED.  ALL THERAPY ADJUSTMENTS WOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON GUARDIAN VALUES.  GUARDIAN RT PROVIDES REAL-TIME GLUCOSE VALUES THAT ALLOW USERS TO TRACK PATTERNS IN GLUCOSE CONCENTRATIONS AND TO POSSIBLY IDENTIFY EPISODES OF LOW AND HIGH BLOOD GLUCOSE EPISODES.  IT ALSO STORES THE DATA SO THAT IT CAN BE ANALYZED TO TRACK PATTERNS.  GLUCOSE DATA CAN BE FURTHER DOWNLOADED TO PC SOFTWARE FOR ANALYSIS OF HISTORICAL GLUCOSE VALUES.
P980035|S039|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|KAPPA 700, 800, 900/SIGMA/ENPULSE|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2004|09/22/2004|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P970012|S016|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC KAPPA 400 SERIES PACEMAKERS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2004|09/22/2004|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P890003|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON LEGACY 11 DR|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2004|09/22/2004|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P980016|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS VR, DR/MAXIMO/ MAXIMO DR/ INTRINSIC 30/INTRINSIC|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2004|09/22/2004|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P010031|S016|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS/INSYNC III (MARQUIS)/INSYNC II (MARQUIS)/INSYNC II (PROTECT)/INSYNC MAXIMO/PRODIGY DR|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2004|09/22/2004|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P000009|S013|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PROGRAMMER SOFTWARE               A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2004|09/17/2004|||APPR|APPROVAL FOR THE USE OF THE PROGRAMMER SOFTWARE               A-K00.2.U IN THE LEXOS, BELOS AND CARDIAC AIRBAG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P980007|S006|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ABBOTT ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2004|09/10/2004|||OK30|CHANGES TO THE METHOD FOR ADDITION OF MAK-33 TO THE ANTI-PSA COATED MICROPARTICLES COMPONENT OF THE REAGENT PACK FOR THE ABBOTT ARCHITECT FREE PSA.
P910007|S012|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE|ABBOTT ARCHITECT TOTAL PSA|JJE|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2004|09/10/2004|||OK30|CHANGES TO THE METHOD FOR ADDITION OF MAK-33 TO THE ANTI-PSA COATED MICROPARTICLES COMPONENT OF THE REAGENT PACK FOR THE ABBOTT ARCHITECT TOTAL PSA.
P030002|S002|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMODATING INTRAOCULAR LENS (IOL)|NAA|OP|Special (Immediate Track)|Other Report|N|08/30/2004|09/29/2004|||APPR|APPROVAL TO MODIFY THE DEVICE DESCRIPTION IN THE PHYSICIAN LABELING.
P980003|S013|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/30/2004|10/14/2004|||APPR|APPROVAL FOR CHANGES MADE TO THE INTERNAL DISTAL TIP CONFIGURATION AND THE CATHETER SHAFT AS WELL AS CHANGES IN THE MANUFACTURING PROCESS TO BOND THE STEERING MECHANISM TO THE BRAIDED SHAFT FOR THE CHILLI II CARDIAC ABLATION CATHETER.
P970004|S029|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM                  FOREMAN NEEDLE|EZW|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/30/2004|08/04/2005|||APPR|APPROVAL FOR: 1) SHIPMENT OF PATIENT CABLE (MODEL 041831) AFTER MANUFACTURING TO MEDTRONIC NEUROLOGICAL DIVISION, SULLIVAN LAKE FACILITY, MINNEAPOLIS, MINNESOTA, FOR CLEANING, PACKAGING AND ETHYLENE OXIDE STERILIZATION, 2) EXTENSION OF THE CURRENT 2-YEAR SHELF LIFE OF THE PATIENT CABLE TO 4 YEARS USING ETHYLENE OXIDE STERILIZATION AND 3) LABELING CHANGES THAT INVOLVE COMBINING THE SEPARATE MANUALS FOR THE MODEL 3065U KIT AND THE MODEL 3057 LEAD INTO ONE MANUAL AND TO REPLACE THE COMBINED MANUAL FOR MODELS 041831, 041829, 041828, 041827 AND 041826 WITH SEPARATE SINGLE SHEET IFUS (INFORMATION FOR USE).
P970004|S030|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM TINED LEAD|EZW|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/30/2004|11/24/2004|||APPR|APPROVAL FOR MODIFICATION OF THE INFORMED CONSENT DOCUMENT, CASE REPORT FORMS, THE INVESTIGATOR AGREEMENT, AND THE VOIDING DIARY.
P880086|S101|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/30/2004|11/22/2004|||APPR|APPROVAL FOR THE FOLLOWING: 1) A FIRMWARE MODIFICATION TO THE IDENTITY/IDENTITY ADX FAMILY OF PACEMAKERS TO CORRECT A POTENTIAL CONDITION THAT WOULD RESULT IN HARDWARE BACK-UP VVI PACING; AND 2) A COMPONENT DESIGN CHANGE TO IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILY OF PACEMAKERS MODIFYING THE PRINTED CIRCUIT BOARD USED TO CONNECT THE FEEDTHROUGH TO THE PACEMAKER CIRCUITRY.
P990030|S005|ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|3600 S.W 47TH AVENUE||GAINESVILLE|FL|32608||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/2004|09/13/2004|||APPR|APPROVAL FOR A NEW TRADE NAME FOR THE DEVICE PREVIOUSLY KNOWN AS THE COSTASIS/DYNASTAT SURGICAL HEMOSTAT:  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL SURGICAL HEMOSTAT AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P870024|S044|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (orthokeratology)|PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES|MUW|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2004|09/24/2004|||OK30|MODIFICATION OF A SPECIFIC PROCESS OF MANUFACTURE TO REDUCE THE HYDRATION TIME AND IMPROVE THE COMFORT FOR THE CONTACT LENS USER.
P010062|S002|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT|NUU|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/2004|12/03/2004|||APPR|APPROVAL TO REVISE THE PROFESSIONAL FITTING AND INFORMATION GUIDE PRODUCT LABELING TO INCLUDE FITTING GUIDELINES FOR CORNEAL TOPOGRAPHY-BASED FITTING METHODS AND OTHER MINOR CHANGES AND GRAMMATICAL CORRECTIONS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE SAME PRIOR APPROVED INDICATIONS FOR USE.
P990046|S013|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVES|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/2004|08/16/2007|||APPR|APPROVAL FOR 22/25 MM MITRAL VALVES, MODELS 501DM22, 503DM22 AND 500DM25.
P910077|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/2004|02/10/2005|||APPR|APPROVAL FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM.  THE MODEL 3120 PRM IS INTENDED TO BE USED AS A COMPLETE SYSTEM TO COMMUNICATE WITH GUIDANT IMPLANTABLE PULSE GENERATORS.  THE SOFTWARE IN USE CONTROLS ALL COMMUNICATION FUNCTIONS FOR THE PULSE GENERATOR. FOR DETAILED SOFTWARE APPLICATION INSTRUCTIONS, REFER TO THE SYSTEM GUIDE FOR THE GUIDANT PULSE GENERATOR BEING INTERROGATED.
P910066|S020|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL1000/OL1000 SC AND SPINALOGIC BONE BROWTH STIMULATORS|LOF|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2004|04/13/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT DJ ORTHOPEDICS, LLC, VISTA, CALIFORNIA.
P910023|S075|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|DXY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/2004|01/19/2005|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO DESCRIBE THE PROTOCOL AND RESULTS FROM THE DEFINITE CLINICAL TRIAL.
P010013|S011|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/2004|03/07/2005|||APPR|APPROVAL FOR REVISED INSTRUCTIONS FOR USE, INCLUDING RESULTS FROM THE THREE-YEAR FOLLOW UP, IMPROVED CONSISTENCY, AND A REVISION TO THE CONTRAINDICATIONS REGARDING LONG-TERM MEDICAL THERAPY.
P020033|S002|INDEPENDENCE TECHNOLOGY, L.L.C.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Wheelchair, stair climbing|INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM|IMK|PM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/2004|03/15/2005|||APPR|APPROVAL FOR GENERATIONAL CHANGES TO THE APPROVED DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INDEPENDENCE IBOT 4000 MOBILITY SYSTEM.  THE DEVICE IS INDICATED FOR INDIVIDUALS WHO HAVE MOBILITY IMPAIRMENTS AND THE USE OF AT LEAST ON UPPER EXTREMITY.  THE DEVICE IS INTENDED TO PROVIDE MOBILITY ON SMOOTH SURFACES AND INCLINES AT HOME, AT WORK ,AND IN OTHER ENVIRONMENTS; MOVEMENT ACROSS OBSTACLES, UNEVEN TERRAIN, CURBS, GRASS, GRAVEL AND OTHER SOFT SURFACES; MOBILITY IN A SEATED POSITION AT AN ELEVATED HEIGHT; ASCENT AND DECENT OF STAIRS WITH OR WITHOUT ASSISTANCE; AND MOBILITY AND TRANSPORTATION.
P000013|S005|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEONICS ABC/TRIDENT SYSTEMS|MRA|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2004|10/22/2004|||APPR|APPROVAL FOR EXPANDED INDICATIONS FOR USE (INFLAMMATORY JOINT DISEASE AND REVISION HIP ARTHROPLASTY) AS WELL AS REVISIONS TO THE PACKAGE INSERT AND PATIENTS LABELING.
P830055|S089|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2004|10/14/2004|||APPR|APPROVAL FOR THE ADDITION OF 29 MM MBT REVISION SLEEVES, SIZE MEDIUM LCS COMPLETE FEMORAL AUGMENT BLOCKS, AND THICKER MBT REVISION TIBIAL TRAYS TO THE EXISTING SYSTEM TO PROVIDE SURGEONS WITH A FULL RANGE OF IMPLANT OPTIONS FOR TOTAL KNEE ARTHROPLASTY.
P950020|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, angioplasty, peripheral, transluminal|FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)|LIT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/2004|07/18/2005|||APPR|APPROVAL FOR DESIGN, MANUFACTURING, AND LABELING CHANGES IN THE CUTTING BALLOON, BOTH OVER-THE-WIRE (OTW) AND MONORAIL (MR) CONFIGURATIONS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLEXTOME CUTTING BALLOON AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.
P980044|S003|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/14/2004|01/20/2006|||APPR|APPROVAL FOR LABELING CHANGES INCLUDING MODIFYING THE DIRECTIONS FOR USE SECTION TO INCLUDE A STATEMENT REGARDING THE USE OF A COURSE OF 3 INJECTIONS, AND ADDING INFORMATION ABOUT ADVERSE EVENTS.
P980049|S017|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2004|12/08/2004|||APPR|APPROVAL FOR THE ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWARE FOR THE CPR3 PROGRAMMING HEAD.
P020025|S007|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000XP CARDIAC ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2004|10/12/2004|||OK30|ELIMINATION OF A CLEANING AGENT FROM THE RING CLEANING PROCEDURE AND THE IMPLEMENTATION OF A NEW AUTOMATED UV CURING FIXTURE.
P000014|S009|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/2004|09/27/2004|||APPR|APPROVAL FOR A CHANGE FROM THE QUALITATIVE DETECTION OF TOTAL ANTI-HBS IN HUMAN SERUM TO A QUANTITATIVE DETECTION OF TOTAL ANTI-HBS IN HUMAN SERUM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS.  THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK IS INDICATED FOR:  "THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM.  ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS, IN WHOM ETIOLOGY IS UNKNOWN."  THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS IS INDICATED FOR: "FOR USE IN THE CALIBRATION OF THE VITROS ICI/ECIQ IMMUNODIAGNOSTIC SYSTEM FOR THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK."
P040012|S001|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|09/16/2004|09/24/2004|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P000043|S009|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 BPH|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2004|10/18/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE AT AMERICAN MEDICAL SYSTEMS (AMS), MINNETONKA, MINNESOTA.  AMS WILL DUPLICATE MANUFACTURE THE TEMPERATURE SENSOR AND REFERENCE PROBE AND CONDUCT LAPTOP IMAGING AND CONSOLE BURN-IN.
P030025|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/20/2004|10/21/2004|||APPR|APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTION REGARDING APPROPRIATE METHODS TO BE USED WHEN A PHYSICIAN EXPERIENCES WITHDRAWAL RESISTANCE FOLLOWING STENT DEPLOYMENT AND BALLOON DEFLATION.
P020014|S008|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2004|01/31/2005|||APPR|APPROVAL FOR A PROPOSED PACKAGING MODIFICATION AND SUBSEQUENT CHANGES TO THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE AND SHELF LIFE VALIDATION STUDY.
P890003|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MODEL 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/20/2004|10/19/2004|||APPR|APPROVAL FOR MODEL 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE.
P010003|S004|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|CRYOLIFE BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/21/2004|10/20/2004|||APPR|APPROVAL FOR ADDING A BOXED WARNING TO BE ADDED TO THE LABELING.
P000029|S010|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/22/2004|11/02/2004|||APPR|APPROVAL FOR MODIFICATION OF THE PARENT/PATIENT BROCHURE.
P000054|S003|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2004|08/22/2005|||APPR|APPROVAL FOR THE ADDITION OF A RAW MATERIAL SUPPLIER.
P000058|S014|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2004|08/22/2005|||APPR|APPROVAL FOR THE ADDITION OF A RAW MATERIAL SUPPLIER.
P930016|S020|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/21/2004|03/17/2005|05M-0151|04/19/2005|APPR|APPROVAL FOR THE VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM.  THE DEVICE USES A 6.0 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR EE AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS; 2) IN PATIENTS 21 YEARS OF ATH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.
P940034|S016|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST|MWA|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2004|10/08/2004|||OK30|ELIMINATION OF A SPECIFICATION FOR THE CONTROL REAGENTS THAT ARE NO LONGER INCLUDED AS PART OF THE MTD TEST KIT.
P930039|S020|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 6947|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/10/2004|02/07/2006|||APPR|APPROVAL FOR CHANGE TO THE MONOLITHIC CONTROLLED-RELEASED DEVICE (MCRD) AND ADDITION OF DEXAMETHASONE SODIUM PHOSPHATE (DSP) TO THE DISTAL TIP OF THE LEADS PREVIOUSLY LISTED.
P970015|S029|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|LT-CAGE LUMBAR TAPERED FUSION DEVICE|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/2004|07/22/2005|||APPR|APPROVAL FOR THE ADDITION OF THE 14MM X 26MM CAGE TITANIUM LT-CAGE LUMBAR TAPERED FUSION DEVICE.  THE DEVICE REMAINS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL.  LT-CAGE DEVICES ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH.  PATIENTS RECEIVING THE LT-CAGE LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE LT-CAGE DEVICE.
P920015|S031|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 6947|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/10/2004|02/07/2006|||APPR|APPROVAL FOR CHANGE TO THE MONOLITHIC CONTROLLED-RELEASED DEVICE (MCRD) AND ADDITION OF DEXAMETHASONE SODIUM PHOSPHATE (DSP) TO THE DISTAL TIP OF THE LEADS PREVIOUSLY LISTED.
P930038|S041|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2004|11/04/2004|||APPR|APPROVAL FOR A NEW ANCHOR DESIGN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIOSEAL VASCULAR CLOSURE DEVICE STS PLUS.
P990064|S010|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES|DYE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/23/2004|11/18/2004|||APPR|APPROVAL FOR ADDITIONAL PRODUCT LINES OF THE MOSAIC PORCINE BIOPROSTHESIS AND THE HANCOCK II BIOPROSTHESIS WHICH WILL USE SMALLER SEWING RING DIAMETERS.
P980043|S005|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/23/2004|11/18/2004|||APPR|APPROVAL FOR ADDITIONAL PRODUCT LINES OF THE MOSAIC PORCINE BIOPROSTHESIS AND THE HANCOCK II BIOPROSTHESIS WHICH WILL USE SMALLER SEWING RING DIAMETERS.
P010012|S032|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 3 IS-1 LEAD MODELS: 4548/4549/4550|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/23/2004|11/24/2004|||APPR|APPROVAL FOR CHANGE OF LEAD CONNECTOR FROM LV-1 TO IS-1.
P860057|S024|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS, MODELS 2700, 2700TFX, 2800,2800TFX, 3000, 3000TFX,6900P (PERI...|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2004|12/29/2004|||APPR|APPROVAL FOR AN ALTERNATIVE LIQUID STERILANT PROCESSING SOLUTION.
P870056|S017|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 AND VALVED CONDUIT MODEL 4300|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2004|12/29/2004|||APPR|APPROVAL FOR AN ALTERNATIVE LIQUID STERILANT PROCESSING SOLUTION.
P870077|S015|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2004|12/29/2004|||APPR|APPROVAL FOR AN ALTERNATIVE LIQUID STERILANT PROCESSING SOLUTION.
P000007|S004|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2004|12/29/2004|||APPR|APPROVAL FOR AN ALTERNATIVE LIQUID STERILANT PROCESSING SOLUTION.
P010041|S004|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2004|12/29/2004|||APPR|APPROVAL FOR AN ALTERNATIVE LIQUID STERILANT PROCESSING SOLUTION.
P010031|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MAXIMO MODEL 7303 AND MODEL 9998 APPLICATION SOFTWARE, VERSION 1.2|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2004|10/19/2004|||APPR|APPROVAL FOR A SOFTWARE UPDATE TO THE MODEL 9998 APPLICATION SOFTWARE.
P030054|S003|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2004|10/25/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE FEEDTHROUGH ASSEMBLY OF THE EPIC HF DEVICE MODEL V-338 AND MINOR MODIFICATIONS TO PROVIDE CONSISTENCY IN THE MANUFACTURING PROCESS OF EPIC HF AND EPIC DR/VR ICDS.
P000029|S011|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2004|11/12/2004|||APPR|APPROVAL FOR AN INCREASE IN THE SHELF LIFE OF DX-10 FROM 6 MONTHS TO 12 MONTHS.
P950005|S018|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S|DRF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2004|12/16/2005|||APPR|APPROVAL FOR ADDING REMOTE MAGNETIC NAVIGATION TECHNOLOGY TO THE PREVIOUSLY APPROVED CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING AND FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR (4) YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
P870072|S030|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2004|01/19/2005|||APPR|APPROVAL FOR A MODIFIED IVAD TUNNELED PNEUMATIC FITTING AND TO ADD TWO (2) CANNULAE FOR THE IVAD DEVICE; IVAD CURVED SHORT ARTERIAL CANNULA AND IVAD SHORT VENTRICULAR CANNULA WITH 2 SIDE HOLES.
P990012|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/29/2004|03/13/2007|||APPR|APPROVAL FOR THE ADDITION OF A NEW INSTRUMENT PLATFORM. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG AND IS INDICATED:  ELECSYS HBSAG IMMUNOASSAY - FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (SODIUM HEPARIN, K3-EDTA, SODIUM CITRATE). ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD.  THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY ?ECLIA? IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS.  THE ELECSYS HBSAG CONFIRMATORY TEST - FOR THE IN VITRO QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND PLASMA (SODIUM HEPARIN, EDTA-K3, SODIUM CITRATE) SAMPLES REPEATEDLY REACTIVE WHEN TESTED WITH THE ELECSYS HBSAG IMMUNOASSAY. THE ELECSYS HBSAG CONFIRMATORY IMMUNOASSAY IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS.  ELECSYS PRECICONTROL HBSAG - FOR QUALITY CONTROL OF THE ELECSYS HBSAG IMMUNOASSAY ON THE ELECSYS 2010 AND MODULAR ANALYTICS E170 ANALYZERS WHEN TESTING HUMAN SERUM. THE PERFORMANCE OF THE PRECICONTROL HBSAG HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAY.
P010059|S002|MORCHER GMBH|KAPUZINERWEG 12||STUTTGART, WURTTEMBERG-BADEN||D-703|7037|Ring, endocapsular|CIONNI CAPSULAR TENSION RINGS|MRJ|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/2004|10/14/2005|||APPR|APPROVAL FOR THE MORCHER CIONNI CAPSULAR TENSION RINGS (TYPES 1L, 2L, AND 2C).  THE DEVICE IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK OR PARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION.  CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARY ZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA OR VITRECTOMY), CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI'S SYNDROM.
P950014|S023|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2004|02/18/2005|||APPR|APPROVAL FOR MODIFICATION OF THE PROSTATRON LABELING REGARDING THE TREATMENT OF PATIENTS 1) WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS),  2) IN URINARY RETENTION, AND 3) WITH MEDIAN PROSTATIC LOBES.
P030035|S003|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS|NKE|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2004|04/29/2005|05M-0289|07/26/2005|APPR|APPROVAL FOR THE FRONTIER CARDIAC RESYNCHRONIZATION THERAPY SYSTEM.  THESE DEVICES ARE INDICATED FOR:  1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. 2) THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION.
P010055|S002|PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|CORETHERM SYSTEM MICROWAVE THERMOTHERAPY|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2004|11/05/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MRI MANUFACTURING AND RESEARCH INC (MRI MEDICAL), 4700 S. OVERLAND DRIVE, TUCSON, ARIZONA 85714-3430.  MRI MEDICAL WILL DUPLICATE MANUFACTURE THE MODIFIED PROSTALUND FEEDBACK TREATMENT (PLFT) CATHETER.
P920023|S018|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESIS|MES|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2004|10/15/2004|||APPR|APPROVAL FOR THE USE OF NUSIL MED 360 (1,000 CP) TO LUBRICATE THE DELIVERY TOOL AND TO CHANGE THE POSITIONING OF THE GRAPPLE PORTION OF THE DELIVERY TOOL.
P970008|S024|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2004|02/18/2005|||APPR|APPROVAL FOR MODIFICATION OF THE PROSTATRON LABELING REGARDING THE TREATMENT OF PATIENTS 1) WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS),  2) IN URINARY RETENTION, AND 3) WITH MEDIAN PROSTATIC LOBES.
P950042|S003|NOVADAQ TECHNOLOGIES, INC.|2585 SKYMARK AVENUE, STE. 306||MISSISSAUGA, ONTARIO||L4W 4||SYSTEM, IMAGING, FLUORESCENCE|ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)|MRK|EN|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2004|06/30/2005|05M-0284|07/18/2005|APPR|APPROVAL FOR THE ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE).  THIS DEVICE IS INDICATED FOR USE WITH FLUORESCENCE IMAGING DURING BRONCHOSCOPY AS AN ADJUNCT TO WHITE LIGHT IMAGING, TO DETECT AND LOCALIZE TISSUE SUSPICIOUS FOR MODERATE OR SEVERE DYSPLASIA, CARCINOMA IN SITU, OR INVASIVE CANCER IN PATIENTS WITH SUSPECTED OR PREVIOUSLY TREATED LUNG CANCER.
P020026|S011|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2004|05/29/2005|||APPR|APPROVAL FOR AN ANALYTICAL TESTING LABORATORY LOCATED AT PHARMACEUTICAL SOURCING GROUP AMERICAS (PSGA), ALSO KNOWN AS JANSSEN PHARMACEUTICALS, INC., TITUSVILLE, NEW JERSEY.
P030006|S003|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|10/01/2004|03/24/2005|||APPR|APPROVAL OF A MODIFIED POST-APPROVAL STUDY FOR THE DEVICE.
P960028|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|SOFT ACRYLIC MULTIFOCAL ARRAY 2 (MODELS AA40E AND AA50) AND REZOOM (MODEL NXG1) INTRAOCULAR LENSES|MFK|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/2004|03/23/2005|||APPR|APPROVAL FOR SOFT ACRYLIC MULTIFOCAL ARRAY 2 (MODELS AA40E AND AA50) AND REZOOM (MODEL NXG1) INTRAOCULAR LENSES.
P800002|S014|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2004|10/29/2004|||OK30|ELIMINATION AND MODIFICATION OF THE ENDOTOXIN TESTING AND MODIFICATION OF THE LIT SEAL STRENGTH TESTING AND MODIFICATION OF THE FOIL POUCH SEAL STRENGTH TESTING.
P890003|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|2490D/E CARELINK MONITORS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2004|10/25/2004|||APPR|APPROVAL FOR THE MODEL 2490E & 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH INSYNC II PROTECT MODEL 7295, INSYNC MAXIMO MODEL 7303, ONYX VR MODEL 7290CX, INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
N17600|S021|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) FLOUR|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2004|10/29/2004|||OK30|ELIMINATION AND MODIFICATION OF THE ENDOTOXIN TESTING AND MODIFICATION OF THE LIT SEAL STRENGTH TESTING AND MODIFICATION OF THE FOIL POUCH SEAL STRENGTH TESTING.
P960040|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DIAGNOSTIC RESTORATION TOOL (DRT) MODEL 2725, VERSION 2.2|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2004|10/29/2004|||APPR|APPROVAL FOR THE DIAGNOSTIC RESTORATION TOOL (DRT) MODEL 2725 VERSION 2.2.
P960040|S047|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 2844 VERSION 3.8|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2004|10/29/2004|||APPR|APPROVAL FOR THE PROGRAMMER'S APPLICATION SOFTWARE MODEL 2844 VERSION 3.8.
P010012|S033|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRISM/PRIZM 2/ CONTAK CD2/VITALITY DS/EL MODEL 2844 VERSION 3.8|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2004|10/29/2004|||APPR|APPROVAL FOR THE PROGRAMMER'S APPLICATION SOFTWARE MODEL 2844 VERSION 3.8.
P030050|S001|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|10/04/2004|04/11/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P950029|S021|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|SYMPHONY & ELA RHAPSODY PACEMAKERS|DXY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/07/2004|10/27/2004|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE SYMPHONY AND ELA RHAPSODY PACEMAKERS TO INCLUDE INSTRUCTIONS ABOUT TESTING, SENSING OR PACING WHILE THE PACEMAKER IS OUT OF THE POCKET.
P840001|S074|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/2004|04/08/2005|||APPR|APPROVAL FOR THE RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 6) PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS; 8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC  DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK SURGERIES.
P030025|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2004|05/19/2005|||APPR|APPROVAL FOR EXTENSION OF THE PRODUCT SHELF LIFE FROM 9 MONTHS TO 12 MONTHS.
P000012|S004|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2004|11/04/2004|||OK30|ELIMINATION OF IN-PROCESS TESTING PROVEN AS REDUNDANT.
P880087|S011|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2004|03/04/2005|||APPR|APPROVAL FOR THE USE OF AN ADDITIONAL SUPPLIER OF POLYMETHYLMETHACRYLATE (PMMA) FOR THE PMMA IOLS.
P810032|S051|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA VS-100 MP PC IO|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2004|03/04/2005|||APPR|APPROVAL FOR THE USE OF AN ADDITIONAL SUPPLIER OF POLYMETHYLMETHACRYLATE (PMMA) FOR THE PMMA IOLS.
P840060|S029|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE IOL|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2004|03/04/2005|||APPR|APPROVAL FOR THE USE OF AN ADDITIONAL SUPPLIER OF POLYMETHYLMETHACRYLATE (PMMA) FOR THE PMMA IOLS.
P840001|S075|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, SYNERGY AND SYNERGY VERSITREL IMPLANTABLE SCS SYSTEMS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/2004|04/15/2005|||APPR|APPROVAL FOR THE 1 X 8 LEAD SYSTEM.
P860004|S063|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2004|11/12/2004|||OK30|UPDATING THE FINAL FUNCTIONAL TEST SOFTWARE TO REDUCE HUMAN DATA ENTRY ERRORS AND ADDING AN ADDITIONAL EQUIPMENT INTERFACE TO AVOID CALIBRATION CONSTANT ENTRY ERRORS BY MANUFACTURING OPERATORS.
P950039|S013|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2004|12/06/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORPORATION, MARLBOROUGH, MASSACHUSETTS.
P950020|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, angioplasty, peripheral, transluminal|CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)|LIT|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2004|03/08/2005|||APPR|APPROVAL FOR AN ALTERNATE IN-HOUSE STERILIZATION SITE LOCATED IN QUINCY, MASSACHUSETTS.
P930035|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P3|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P800019|S011|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P940008|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P940031|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR,DISCOVERY,MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P820022|S003|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|CYBERTACH|LWW|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P950001|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE,SELUTE PICOTIP|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P830026|S078|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P960004|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FINELINE,FINELINE II|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P830060|S056|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK BIPOLAR ENDOCARDIAL|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P960006|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P960040|S048|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV,VENTAK VR,VENTAK PRIZM,VITALITY,VITALITY 2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P010012|S034|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD, CONTAK CD 2, EASYTRAK, EASYTRACK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P030005|S004|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|permanent pacemaker Electrode|CONTACK RENEWAL TR|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P840068|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA, VISTA|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P860007|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH|LWW|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P030025|S008|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 CORONARY STENT SYSTEM|NIQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/22/2004|||APPR|APPROVAL FOR ADDITION OF SPECIFICATIONS FOR THE DVT VISUAL INSPECTION THAT IS CONDUCTED AFTER THE CONE-PUFF PROCEDURE.
P890061|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P910020|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P910073|S048|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK,ENDOTAK ENDURANCE, ENDOTAK RELIANCE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P910077|S047|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX, VENTAK MINI|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2004|11/19/2004|||OK30|CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
P990001|S016|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|SELECTION AFM, VITATRON C60 DR, C20 SR, T60 DR, AND T20 SR PACING SYSTEMS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2004|11/22/2004|||APPR|APPROVAL FOR SOFTWARE REVISIONS.
P030025|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2004|03/09/2005|||APPR|APPROVAL FOR MODIFICATIONS TO LABELING CONTAINED IN THE WARNINGS/ PRECAUTIONS SECTIONS OF THE DIRECTIONS FOR USE (DFU) AND PATIENT GUIDES BASED UPON UPDATED SAFETY INFORMATION RELATED TO MAGNETIC RESONANCE IMAGING (MRI) PERFORMED AT 3 TESLA.
P020009|S017|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2004|03/09/2005|||APPR|APPROVAL FOR MODIFICATIONS TO LABELING CONTAINED IN THE WARNINGS/ PRECAUTIONS SECTIONS OF THE DIRECTIONS FOR USE (DFU) AND PATIENT GUIDES BASED UPON UPDATED SAFETY INFORMATION RELATED TO MAGNETIC RESONANCE IMAGING (MRI) PERFORMED AT 3 TESLA.
P990074|S016|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINED-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2004|12/17/2004|||APPR|APPROVAL FOR REVISED LABELING THAT REFLECTS 7-YEAR POST-APPROVAL STUDY DATA.
P000044|S004|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2004|11/04/2004|||OK30|ADDITION OF NEW REAGENT DISPENSING EQUIPMENT.
P010021|S004|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2004|11/04/2004|||OK30|ADDITION OF NEW REAGENT DISPENSING EQUIPMENT.
P000014|S010|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC ANTI-HBS REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2004|11/04/2004|||OK30|ADDITION OF NEW REAGENT DISPENSING EQUIPMENT.
P030024|S002|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice||N|10/26/2004|11/04/2004|||OK30|ADDITION OF NEW REAGENT DISPENSING EQUIPMENT.
P030026|S002|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2004|11/04/2004|||OK30|ADDITION OF NEW REAGENT DISPENSING EQUIPMENT.
P010013|S012|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE GLOBAL IMPENDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2004|03/24/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC SURGICAL PRODUCTS, HEREDIA, COSTA RICA.
P870072|S031|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2004|11/17/2004|||OK30|CHANGE IN TH JOINING PROCESS FOR THE PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) CASE FITTINGS AND A CHANGE FROM A MACHINING PROCESS TO AN INJECTION MOLDING PROCESS FOR THE MANUFACTURE OF PVAD COMPONENTS.
P010039|S003|SIEMENS MEDICAL SOLUTIONS USA, INC.|51 VALLEY STREAM PKWY.||MALVERN|PA|19355|1406|Generator, shock-wave, for pain relief|SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)|NBN|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|10/28/2004|09/27/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL PROTOCOL.
P860019|S201|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK 2 MONORAIL AND MAVERICK OTW PTCA CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2004|05/11/2005|||APPR|APPROVAL FOR CHANGE IN THE MANUFACTURING PROCESS FOR FORMING THE FOLDING THE BALLOON WINGS FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P890003|S079|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|CARELINK MONITOR MODELS 2490G, 2490H AND 2490J|DXY|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|11/01/2004|02/15/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORPORATION, BOTHELL, WASHINGTON.
P810046|S217|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|RX VOYAGER CORONARY DILATATION CATHETER|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2004|11/22/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT IRELAND, TIPPERY, IRELAND.
P030025|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2004|11/11/2004|||OK30|CHANGE IN THE BACTERIAL ENDOTOXIN TEST USED AS PART OF THE FINISHED DEVICE TESTING.
P010012|S036|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 1/3/3HE CRT-D DEVICES|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2004|03/23/2007|||APPR|APPROVAL FOR THE CONSULT SOFTWARE MODEL 2845 V2.10 TO BE USED TO ENABLE THE ABILITY TO PROGRAM THE V-V TIMING INTERVAL IN THE CONTAK RENEWAL MODEL H135; CONTAK RENEWAL 2 MODELS H170 AND 175; AND CONTAK RENEWAL 3 HE MODELS H177 AND H179 CRT-D DEVICES.
P910031|S022|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2004|02/16/2006|||APPR|APPROVAL FOR THE MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW).  THE MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE NC MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P010068|S005|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS DS 8MM DIAGNOSTIC/ABLATION TIP CATHETER|OAD|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|11/03/2004|11/16/2004|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.
P020009|S018|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 STENT DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2004|11/30/2004|||OK30|ADDITION OF AN ALTERNATIVE SUPPLIER OF STAINLESS STEEL USED IN THE MANUFACTURE OF STENT COMPONENTS.
P030025|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 STENT DELIVERY SYSTEM|NIQ|CV|30-Day Notice||N|11/05/2004|11/30/2004|||OK30|ADDITION OF AN ALTERNATIVE SUPPLIER OF STAINLESS STEEL USED IN THE MANUFACTURE OF STENT COMPONENTS.
P970003|S055|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/08/2004|02/01/2005|||APPR|APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE - VERSION 7.0 FOR USE WITH MODEL 100 VERSIONS B AND C, MODEL 101 VERSIONS 1 AND 2, AND MODELS 102 AND 102R PULSE GENERATORS.
P950020|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, angioplasty, peripheral, transluminal|ULTRA2 CUTTING BALLOON MONORAIL(MR)|LIT|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2004|03/16/2005|||APPR|APPROVAL FOR  MANUFACTURING SITES LOCATED AT INTERVENTIONAL TECHNOLOGIES EUROPE, LTD., DONEGAL, IRELAND AND EBIS IOTRON, LTD., OXON, GREAT BRITAIN.
P010012|S037|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK RENEWAL 3 AVT CRT-D SYSTEM|NIK|CV|Panel Track|Change Design/Components/Specifications/Material|N|11/10/2004|03/13/2008|08M-0243|04/24/2008|APPR|APPROVAL FOR THE CONTAK RENEWAL 3 AVT AND CONTAK RENEWAL 3 AVT HE SYSTEMS.  THE SYSTEMS ARE INDICATED FOR THE FOLLOWING: CONTAK RENEWAL 3 AVT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS. CONTAK RENEWAL 3 AVT PROVIDES ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT FOR PATIENTS WITH A HISTORY OF OR WHO ARE AT RISK OF DEVELOPING ATRIAL ARRHYTHMIAS.
P020004|S008|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2004|12/02/2004|||OK30|CHANGE INVOLVING A NEW SPECIFICATION FOR THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (TRUNK) SEAMLINE INSPECTION.
P980018|S003|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2004|12/30/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARK A/S, GLOSTRUP, DENMARK.
P030017|S004|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/12/2004|01/21/2005|||APPR|APPROVAL FOR LABELING CHANGES.
P010012|S038|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2004|12/15/2004|||OK30|ADDITION OF AN ADHESIVE, A NEW MANUFACTURING STEP, AND PRE-FORMING OF A WIRE.
P990009|S016|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL MATRIX HEMOSTATIC AGENT FLOSEAL ENDOSCOPIC APPLICATOR|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/15/2004|03/31/2005|||APPR|APPROVAL FOR A MODIFICATION TO THE ENDOSCOPIC APPLICATOR AND A MODIFICATION OF THE "INDICATION FOR USE" FOR THE ENDOSCOPIC APPLICATOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL ENDOSCOPIC APPLICATOR AND IS INDICATED FOR USE IN DELIVERING FLOSEAL MATRIX HEMOSTATIC SEALANT TO BLEEDING SURGICAL SITES THROUGH A 5 MM OR LARGER TROCAR.
P000044|S005|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2004|12/08/2004|||OK30|CHANGE IN THE MANUFACTURING EQUIPMENT AND MANUFACTURING PROCESS STEPS ACCEPTANCE CRITERIA ASSOCIATED WITH THIS EQUIPMENT CHANGE.
P970015|S030|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)|MAX|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/15/2004|02/04/2005|||APPR|APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS.  SPECIFICALLY, THESE DESIGN CHANGES INVOLVED THE INCORPORATION OF A ROUNDED PROFILE TO THE CLOSED END OF THE TAPERED CAGE COMPONENTS.  THE MODIFIED TAPERED CAGE COMPONENTS CAN ONLY BE IMPLANTED VIA AN ANTERIOR OPEN SURGICAL APPROACH.
P000058|S015|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPARED FUSION DEVICE|NEK|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/15/2004|02/04/2005|||APPR|APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS.  SPECIFICALLY, THESE DESIGN CHANGES INVOLVED THE INCORPORATION OF A ROUNDED PROFILE TO THE CLOSED END OF THE TAPERED CAGE COMPONENTS.  THE MODIFIED TAPERED CAGE COMPONENTS CAN ONLY BE IMPLANTED VIA AN ANTERIOR OPEN SURGICAL APPROACH.
P000021|S004|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION TPSA FLEX REAGENT CARTRIDGE|LTJ|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|11/15/2004|12/02/2004|||APPR|APPROVAL OF THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION XPAND PLUS ANALYZER.
P950029|S022|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|SYMPHONY DR 2550 MODE AND ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2004|04/27/2005|||APPR|APPROVAL FOR THE AAISAFER2 PACING MODE AND THE ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYMPHONY DR 2550 AND IS INDICATED FOR: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY.  2) THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE, BUT ARE NOT RESTRICTED TO: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK, SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK, SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS, BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS AND VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES.  IN ADDITION, THE DUAL-CHAMBER AND ATRIAL TRACKING MODES IS INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.  DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE: VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT AND VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.
P010031|S018|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC INSYNC III MARQUIS,MAXIMO & SENTRY|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2004|04/08/2005|||APPR|APPROVAL FOR THE MEDTRONIC INSYNC III MARQUIS MODEL 7279 WITH MODEL 9989 APPLICATION SOFTWARE, MEDTRONIC INSYNC MAXIMO MODELS 7303 AND 7304 WITH MODEL 9998 APPLICATION SOFTWARE, MEDTRONIC INSYNC SENTRY MODELS 7297 AND 7299 WITH MODEL 9998 APPLICATION SOFTWARE.  THE DEVICES ARE INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THIS SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION.
P990004|S007|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P|LMF|SU|Normal 180 Day Track No User Fee|Express GMP Supplement|N|11/16/2004|01/07/2005|||APPR|APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT ISOTRON PLC, SWINDON, UNITED KINGDOM.
P030025|S013|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|11/17/2004|10/19/2006|||APPR|APPROVAL FOR A REVISION PARTICULATE TESTING METHOD AND REVISING REGULATORY AND BATCH RELEASE PARTICULATE SPECIFICATIONS.
P970027|S002|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2004|12/03/2004|||OK30|CHANGE TO THE ACCEPTANCE CRITERIA FOR MICROPARTICLE MANUFACTURING.
P970027|S003|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT AXSYM ANTI-HCV|MZO|MI|Special (Immediate Track)||N|11/18/2004|12/14/2004|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
P910077|S048|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/19/2004|03/02/2005|||APPR|APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1 WHICH IS INDICATED FOR INTERROGATING AND DOWNLOADING DIAGNOSTIC INFORMATION OBTAINED BY GUIDANT'S PACEMAKER AND DEFIBRILLATOR CARDIAC RESYNCHRONIZATION THERAPY (CRT-P AND CRT-D DEVICES.
P980035|S040|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|KAPPA 700, KAPPA 900, ENPULSE|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2004|12/20/2004|||OK30|REDUCTION OF HYBRID BURN-IN TIME FOR SEVERAL MEDTRONIC PRODUCTS.
P890064|S017|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE HPV DNA TEST|MAQ|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/19/2004|12/14/2004|||APPR|APPROVAL FOR PACKAGING QUALITY CONTROL MATERIAL IN THE HYBRID CAPTURE 2 HPV DNA TEST KITS THAT WAS PREVIOUSLY PROVIDED UNDER A SEPARATE PRODUCT CODE, AS WELL AS THE ADDITION OF AN UPPER LIMIT FOR THE HPV POSITIVE CONTROL TEST VALUES.
P970058|S021|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER D|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|11/19/2004|01/05/2005|||APPR|APPROVAL TO EXPAND THE USE OF THE IMAGECHECKER D TO ALLOW COMPUTER AIDED DETECTION (CAD) PROCESSING OF FULL-FLIED DIGITAL MAMMOGRAPHY (FFDM) IMAGES ACQUIRED WITH THE SIEMENS NOVATION FFDM SYSTEM.
P840001|S076|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL3, SYNERGY, SYNERGY VERSITREL, AND RESTORE SPINAL CORD STIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/2004|06/06/2005|||APPR|APPROVAL FOR MRI LABELING UPDATES TO THE ABOVE LISTED SPINAL CORD STIMULATION (SCS) SYSTEMS.
P030005|S005|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|permanent pacemaker Electrode|GUIDANT CONTAK RENEWAL TR MODELS H125 AND H120|DTB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/22/2004|03/08/2005|||APPR|APPROVAL FOR MODIFIED DEVICE LABELING TO DESCRIBE THE COMPANION CLINICAL STUDY.
P990053|S011|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2004|02/25/2005|||APPR|APPROVAL FOR THE QUALIFICATION OF AN ADDITIONAL SUPPLIER FOR THE TWO LIGHT EMITTING DIODES WITHIN THE OXIMETRY SENSOR.
P920004|S020|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL ON-SITE PRECISION CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/22/2004|05/19/2005|||APPR|APPROVAL FOR THE VASOSEAL ON-SITE PRECISION CLOSURE DEVICE.
P960040|S049|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PROGRAMMER SOFTWARE APPLICATION MODEL 2812 VERSION 1.3|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/26/2004|02/18/2005|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE MODEL 2812 VERSION 1.3.
P970043|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADAR 6000 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/2004|05/01/2006|||APPR|APPROVAL FOR CHANGES IN THE LADARVISION 4000 SYSTEM INCLUDING A NEW CONFIGURATION OF THE ILLUMINATION SYSTEM, UPGRADES TO THE LASER COMPUTER AND OPERATING SYSTEM, AND VARIOUS OTHER HARDWARE AND SOFTWARE CHANGES INTENDED TO ADDRESS COMPLIANCE WITH EMI REQUIREMENTS, MANAGE COMPONENT OBSOLESCENCE, REDUCE MAINTENANCE REQUIREMENTS, AND ENHANCE ERGONOMIC AND USER INTERFACE FEATURES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADAR 6000 EXCIMER LASER SYSTEM.
P840001|S077|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY PLUS+ (MODEL 7479) AND SYNERGY COMPACT+ (MODEL 7479B) NEUROSTIMULATION SYSTEMS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/2004|04/15/2005|||APPR|APPROVAL FOR THE SYNERGY PLUS+ (MODEL 7479) AND SYNERGY COMPACT+ (MODEL 7479B) NEUROSTIMULATION SYSTEMS WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 6) PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS; 8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC  DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK SURGERIES.
P800019|S012|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P860007|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH|LWW|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P820022|S004|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|CYBERTACH|LWW|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P830026|S079|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P830060|S057|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK, BIPOLAR ENDOCARDIAL|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P910020|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||implantable pacemaker Pulse-generator|RELAY|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P910073|S049|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P840068|S043|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA, VISTA|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P980046|S007|HOME ACCESS HEALTH CORP.|2401 W. HASSELL|SUITE 1510|HOFFMAN ESTATES|IL|60195|5200|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|HEPATITS C CHECK TEST SYSTEM|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/10/2004|||OK30|CHANGE TO A SUPPLIER OF A COMPONENT OF THE HEPATITIS C CHECK TEST SYSTEM.
P910077|S049|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX, VENTAK MINI|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P960006|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P930035|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2, VENTAK P3|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P940008|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P960040|S050|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV, VENTAK VR, VENTAK PRIZM, VITALITY, VITALITY 2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P940031|S033|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR, DISCOVERY, MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P010012|S040|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD, CONTAK CD2, EASYTRAK, EASYTRAK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P950001|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE, SELUTE PICOTIP|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P960004|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FINELINE, FINELINE II|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P030005|S006|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|permanent pacemaker Electrode|CONTAK RENEWAL TR|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P890061|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2004|12/22/2004|||OK30|USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
P890003|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/06/2004|02/18/2005|||APPR|APPROVAL FOR THE ADDITION OF DISTANCE TELEMETRY FUNCTIONALITY TO THE CURRENTLY APPROVED PROGRAMMER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
P040002|S001|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOLOGIX POWERLINK SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/03/2004|02/15/2005|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
N16420|S007|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION|MENTOR POLYTEF PASTE FOR INJECTION|LTG|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2004|01/03/2005|||OK30|CHANGE IN VENDOR OF A RAW MATERIAL FOR POLYTEF PASTE FOR INJECTION.
P960040|S051|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE MODEL T182 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/10/2004|03/01/2005|||APPR|APPROVAL FOR THE VITALITY HE MODEL T182 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2896 VERSION 1.0.  THE DEVICE IS INDICATED FOR USE AS FOLLOWS: GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR ARRHYTHMIAS.
P790017|S083|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|SPRINTER MX2 BALLOON DILATATION CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/10/2004|06/22/2005|||APPR|APPROVAL FOR ADDING A NEW CATHETER TO THE APPROVED PRODUCT LINE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPRINTER MX2 AND IS INDICATED FOR BALLOON DILATATION FOR THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM ? 4.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.  NOTE: BENCH TESTING WAS CONDUCTED WITH THE SPRINTER BALLOON DILATATION CATHETER AND MARKETED BALLOON EXPANDABLE STENTS.  CONSIDERATION SHOULD BE TAKEN WHEN THIS DEVICE IS USED WITH DIFFERENT MANUFACTURERS? STENTS DUE TO DIFFERENCES I STENT DESIGN.
P990034|S005|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED FIXED RATE INFUSION PUMP|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/2004|12/23/2004|||APPR|APPROVAL FOR CHANGES TO THE ISOMED FIXED RATE INFUSION PUMP TECHNICAL MANUAL FOR NEW WARNINGS AND INFORMATION REGARDING INFLAMMATORY MASS AND OTHER TEXT CHANGES.
P980023|S019|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2004|07/18/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES KENTROX RV, KENTROX RV STEROID, KENTROX SL, KENTROX SL STEROID, KENTROX RV-S, KENTROX RV-S STEROID, AND KENTROX SLS STEROID AND ARE INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD.
P950034|S027|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/06/2005|07/11/2007|||APPR|APPROVAL FOR LABELING CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SEPRAFILM ADHESION BARRIER AND IS INDICATED FOR USE IN PATIENTS UNDERGOING ABDOMINAL OR PELVIC LAPAROTOMY AS AN ADJUNCT INTENDED TO REDUCE THE INCIDENCE, EXTENT AND SEVERITY OF POSTOPERATIVE ADHESIONS BETWEEN THE ABDOMINAL WALL AND THE UNDERLYING VISCERA SUCH AS OMENTUM, SMALL BOWEL, BLADDER, AND STOMACH, AND BETWEEN THE UTERUS AND SURROUNDING STRUCTURES SUCH AS TUBES AND OVARIES, LARGE BOWEL, AND BLADDER.
P910031|S023|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2004|02/16/2006|||APPR|APPROVAL FOR THE MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW).  THE MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE NC MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P960058|S040|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2004|03/07/2005|||APPR|APPROVAL FOR UPGRADES TO THE AURIA POWERPAK FOR THE HIRES AURIA PROCESSOR (BEHIND-THE-EAR).
P870024|S045|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens, contact (orthokeratology)|FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES|MUW|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2004|01/07/2005|||OK30|MODIFICATION OF A SPECIFIC PROCESS OF MANUFACTURE TO REDUCE THE HYDRATION TIME AND IMPROVE THE COMFORT FOR THE CONTACT LENS USER.
P030026|S003|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2004|01/04/2005|||OK30|REMOVAL OF IN PROCESS CALIBRATOR TESTING.
P860004|S064|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/16/2004|03/24/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING OF THE SYNCHROMED EL PUMPS TO INCREASE THE SHELF LIFE OF THE 10ML PUMPS TO 24 MONTHS AND THE 18ML PUMPS TO 48 MONTHS.
P860004|S065|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2004|02/22/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE 1) PROTOCOL DRIVER FOR THE SYNCHROMED II APPLICATION SOFTWARE, 2) SYNCHROMED II APPLICATION SOFTWARE, AND 3) FINAL FUNCTIONAL TEST (FFT) MANUFACTURING SOFTWARE.
P040027|S001|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2004|12/29/2004|||OK30|REMOVAL OF A MANUFACTURING AID AND SOME PROCESSING STEPS.
P010032|S013|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2004|05/11/2005|||APPR|APPROVAL FOR THE ADDITION OF FOUR MODELS OF THE S-SERIES LAMITRODE LEADS AS ACCESSORIES TO THE GENESIS FAMILY OF NEUROSTIMULATION IPG DEVICES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME S-SERIES LAMITRODE LEADS (MODEL NUMBERS3243, 3246, 3283 AND 3286) AND IS INDICATED FOR USE AS THE LEAD COMPONENT OF A SPINAL CORD STIMULATION SYSTEM.  THE SPINAL CORD STIMULATION SYSTEM IS USED TO AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR EXTREMITIES.
P920047|S025|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2004|01/10/2005|||OK30|CHANGE IN THE TORQUE HOLE ADHESIVE CURE TIME.
P020025|S008|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2004|01/10/2005|||OK30|CHANGE IN THE TORQUE HOLE ADHESIVE CURE TIME.
P030054|S004|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE 1056T LEFT VENTRICULAR PACING LEAD|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/2004|04/11/2005|||APPR|APPROVAL FOR THE QUICKSITE 1056T LEFT VENTRICULAR PACING LEAD.
P970021|S012|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|CATHETER, BALLOON, TRANSCERVICAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MKN|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/17/2004|01/03/2005|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE, OPERATING MANUAL AND CONTROLLER PULL-OUT CARD.
P030031|S001|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BIOSENSE WEBSTER NAVISTAR/ CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS|OAD|CV|Normal 180 Day Track No User Fee|Other Report|N|12/17/2004|12/19/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P000025|S017|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track||N|12/17/2004|07/10/2008|||APPR|APPROVAL FOR MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH PULSARCI100 IMPLANTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH PULSARCI100 IMPLANTS AND IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: 1) ADULTS EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE A SEVERE TO PROFOUND, BILATERAL SENSONNEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FORM APPROPRIATELY FITTED BINAURAL HEARING AIDS [NOTE: THIS HEARING LOSS MAY BE EVIDENCED BY A BILATERAL PURE TONE AVERAGE OF 70 DB OR GREATER AT 500, 1000 AND 2000 HZ AND BY BEST-AIDED SCORE OF <=40% CORRECT ON OPEN-SET HEARING IN NOISE TEST SENTENCES (HINT)]; 2) CHILDREN TWELVE (12) MONTHS OF AGE AND OLDER WHO DEMONSTRATE A PROFOUND, BILATERAL SENSONNEURAL HEARING LOSS WITH THRESHOLDS OF 90 DB OR GREATER AT 1000 HZ AND OBTAIN LITTLE TO NO BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS [NOTE: THIS HEARING LOSS IN YOUNGER CHILDREN MAY BE EVIDENCED BY A LACK OF PROGRESS IN SIMPLE AUDITORY SKILL DEVELOPMENT, DESPITE APPROPRIATE AMPLIFICATION AND AURAL HABITATION, OVER A THREE TO SIX-MONTH PERIOD.  THIS HEARING LOSS IN OLDER CHILDREN MAY BE EVIDENCED BY A SCORE OF <20% CORRECT ON THE MLNT OR LNT].
P940019|S018|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice||N|12/20/2004|01/14/2005|||OK30|CHANGES IN THE MANUFACTURING PROCESS: 1) INTRODUCTION OF A TIP TUG TEST ON-LINE AT THE FINAL INSPECTION STEP, 2) INTRODUCTION OF AN AUTOMATED AUTO-FEED SYSTEM TO THE EXISTING SWAGER UNIT, AND 3) INTRODUCTION OF SEMI-AUTOMATED MANUFACTURING SIDE ARM CONNECTORS AS AN ALTERNATIVE TO THE MANUAL MANUFACTURING PROCESS.
P930031|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice||N|12/20/2004|01/14/2005|||OK30|CHANGES IN THE MANUFACTURING PROCESS: 1) INTRODUCTION OF A TIP TUG TEST ON-LINE AT THE FINAL INSPECTION STEP, 2) INTRODUCTION OF AN AUTOMATED AUTO-FEED SYSTEM TO THE EXISTING SWAGER UNIT, AND 3) INTRODUCTION OF SEMI-AUTOMATED MANUFACTURING SIDE ARM CONNECTORS AS AN ALTERNATIVE TO THE MANUAL MANUFACTURING PROCESS.
P980033|S012|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice||N|12/20/2004|01/14/2005|||OK30|CHANGES IN THE MANUFACTURING PROCESS: 1) INTRODUCTION OF A TIP TUG TEST ON-LINE AT THE FINAL INSPECTION STEP, 2) INTRODUCTION OF AN AUTOMATED AUTO-FEED SYSTEM TO THE EXISTING SWAGER UNIT, AND 3) INTRODUCTION OF SEMI-AUTOMATED MANUFACTURING SIDE ARM CONNECTORS AS AN ALTERNATIVE TO THE MANUAL MANUFACTURING PROCESS.
P860057|S025|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700,2700TFX,2800,2800TFX,3000,3000TFX,6900P PERIMOUNT PLUS AND 6900PTFX|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2004|01/19/2005|||OK30|CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.
P870077|S016|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS, MODELS 6625L AND 6625-ESR-LP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2004|01/19/2005|||OK30|CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.
P000007|S005|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2004|01/19/2005|||OK30|CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.
P010041|S005|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-SUPRANNULAR BIOPROSTHESIS MODEL 2650|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2004|01/19/2005|||OK30|CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.
P870056|S018|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2004|01/19/2005|||OK30|CHANGE IN THE SUPPLIER OF THE KNITTING OPERATION OF THE POLYESTER FABRIC.
P030026|S004|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2004|01/14/2005|||OK30|MODIFICATION TO THE MICROWELL COATING SPECIFICATION.
P890043|S038|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM|MCX|CV|30-Day Notice||N|12/21/2004|01/14/2005|||OK30|CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE).
P810046|S218|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|CROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2004|01/14/2005|||OK30|MANUFACTURING PROCESS CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE).
P980053|S008|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2004|09/26/2005|||APPR|APPROVAL FOR THE 1 ML SYRINGE USED TO DEPLOY DURASPHERE INJECTABLE BULKING AGENT TO BE CHANGED FROM A POLYCARBONATE SYRINGE WITH THE LATEX-FREE COMPOUND TIP TO A SYRINGE WITH A POLYPROPYLENE SILICONE TIP.
P900023|S042|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/22/2004|03/23/2005|||APPR|APPROVAL FOR A CHANGE TO ONLY THE AB5000 CIRCULATORY SUPPORT SYSTEM THAT WILL ALLOW THE USER AN ALTERNATE MEANS OF REDUCING BLOOD FLOW DURING WEANING BY ADJUSTING THE LEVEL OF VACUUM APPLIED TO THE AB5000 BLOOD PUMP.
P010054|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2004|03/13/2007|||APPR|APPROVAL FOR THE ADDITION OF A NEW INSTRUMENT PLATFORM, AND CHANGING THE ASSAY FROM A QUALITATIVE ASSAY TO A QUANTITATIVE ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS AND IS INDICATED:  ELECSYS ANTI-HBS IMMUNOASSAY -FOR THE IN VITRO QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (EDTA). THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY ?ECLIA? IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS. ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAYBE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.  ELECSYS PRECICONTROL ANTI-HBS - FOR THE QUALITY CONTROL OF THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS. THE PERFORMANCE OF ELECSYS PRECICONTROL ANTI-HBS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.
P900056|S082|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/2004|02/09/2005|||APPR|APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE (DFU) MANUAL FOR THE ROTABLATOR CONSOLE UNIT.  THE CHANGES INCLUDE REMOVAL OF THE REFERENCES TO THE CONSOLE RECORDER CONNECTION, UPDATES TO THE CONTACT INFORMATION AND CATALOG NUMBERS, AND OTHER MINOR CLARIFICATIONS.
P010030|S006|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST (WCD 300) DEVICE WITH APPLICATION SOFTWARE VERSION 4.0|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/27/2004|02/15/2005|||APPR|APPROVAL FOR MINOR CHANGES IN SOFTWARE, HARDWARE AND ASSOCIATED LABELING.
P900039|S015|NEUCOLL, INC.|105 COOPER CT.||LOS GATOS|CA|95032|7604|FILLER, BONE VOID, NON-OSTEOINDUCTION|COLLAGRAFT STRIP BONE GRAFT MATRIX|MBS|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2004|01/24/2005|||OK30|CHANGE IN THE FINAL PRODUCT TESTING FROM RABBIT PYROGENICITY TEST TO A LIMULUS AMEBOCYTE LYSATE (LAL) GEL-CLOT TEST FOR DETERMINING THE PRESENCE OF ENDOTOXINS.
P870072|S033|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2004|03/22/2005|||APPR|APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT TRI-STATE HOSPITAL SUPPLY CORPORATION, YUMA, ARIZONA AND FOR A CHANGE IN THE CYTOTOXICITY TESTING PROCESS.
P920014|S025|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE LVAS SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2004|03/22/2005|||APPR|APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT TRI-STATE HOSPITAL SUPPLY CORPORATION, YUMA, ARIZONA AND FOR A CHANGE IN THE CYTOTOXICITY TESTING PROCESS.
P010032|S014|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/27/2004|03/04/2005|||APPR|APPROVAL FOR THE EON NEUROSTIMULATION SYSTEM, MODEL 3716, WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P000006|S005|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/30/2004|01/12/2005|||APPR|APPROVAL FOR THE ADDITION OF AN ADAPTER TO THE REAR TIP EXTENDERS INCLUDED IN THE ASSEMBLY KIT.
P020018|S005|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/2005|06/09/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE ANCILLARY COMPONENTS FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT.
P980040|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/2005|02/04/2005|||APPR|APPROVAL TO MODIFY THE "INDICATIONS" STATEMENTS FOR ALL LEGALLY MARKETED IOLS UNDER THE ABOVE REFERENCED PMAS TO REFLECT ADULTS AS OPPOSED TO ADULTS OLDER THAN 60 YEARS OF AGE.
P810002|S058|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/03/2005|02/14/2005|||APPR|APPROVAL FOR AN ADDITIONAL CONFIGURATION OF THE AORTIC VALVED GRAFT USING THE SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515) AND IS INDICATED FOR THE REPLACEMENT OF A MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVE AND ASCENDING AORTA.
P000053|S005|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|SPHINCTER 800 URINARY CONTROL SYSTEM|EZY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2005|10/13/2006|||APPR|APPROVAL FOR THE ADDITION OF INHIBIZONE TREATMENT TO COMPONENTS OF THE SPHINCTER 800 URINARY CONTROL SYSTEM, SPECIFICALLY THE CUFFS, PUMPS, AND KINK RESISTANT TUBING.
P890057|S018|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV)|LSZ|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2004|03/10/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE HEAT AND FILTER ON THE EXHALED GAS LIMB OF THE EXISTING PATIENT CIRCUIT.
P810055|S071|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/2005|02/04/2005|||APPR|APPROVAL TO MODIFY THE "INDICATIONS" STATEMENTS FOR ALL LEGALLY MARKETED IOLS UNDER THE ABOVE REFERENCED PMAS TO REFLECT ADULTS AS OPPOSED TO ADULTS OLDER THAN 60 YEARS OF AGE.
P880070|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/2005|02/04/2005|||APPR|APPROVAL TO MODIFY THE "INDICATIONS" STATEMENTS FOR ALL LEGALLY MARKETED IOLS UNDER THE ABOVE REFERENCED PMAS TO REFLECT ADULTS AS OPPOSED TO ADULTS OLDER THAN 60 YEARS OF AGE.
P990080|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON EDGE AND TECNIS FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/2005|02/04/2005|||APPR|APPROVAL TO MODIFY THE "INDICATIONS" STATEMENTS FOR ALL LEGALLY MARKETED IOLS UNDER THE ABOVE REFERENCED PMAS TO REFLECT ADULTS AS OPPOSED TO ADULTS OLDER THAN 60 YEARS OF AGE.
P860004|S066|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED IMPLANTABLE INFUSION SYSTEM FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE)|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2005|02/14/2005|||APPR|APPROVAL FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNCHROMED IMPLANTABLE INFUSION SYSTEM AND IS INDICATED FOR THE CHRONIC INTRATHECAL INFUSION OF PRESERVATIVE-FREE ZICONOTIDE STERILE SOLUTION FOR THE MANAGEMENT OF SEVERE, CHRONIC PAIN.
P970027|S004|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36)|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2005|01/31/2005|||OK30|CHANGE IN THE MANUFACTURE AND TESTING FLOW OF INDEX CALIBRATOR.
P980037|S012|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2005|02/04/2005|||OK30|CHANGE FOR THE SUPPLY LINE NUT OF THE ANGIOJET PUMP SET.
P040006|S001|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|CHARITE ARTIFICIAL DISC|MJO|OR|Normal 180 Day Track No User Fee|Express GMP Supplement|N|01/07/2005|06/16/2005|||APPR|APPROVAL FOR A MANUFACTURING SITES LOCATED AT DEPUY (IRELAND) LTD, CORK, IRELAND, FOR MANUFACTURING AND ISOTRON PLC, MARCUS CLOSE, BERKSHIRE, UNITED KINGDOM, FOR STERILIZATION.
P020006|S008|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MAILSTOP: MB-16|MARLBOROUGH|MA|01752||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|ENTERYX PROCEDURE KIT|LNM|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2005|06/02/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION, WAYNE, NEW JERSEY TO CONDUCT PACKAGING AND LABELING OPERATIONS.
P010012|S041|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3, MODELS H170, H175, H177 AND H179|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/10/2005|02/11/2005|||APPR|APPROVAL FOR LABELING CHANGES.
P970018|S009|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/10/2005|02/11/2005|||APPR|APPROVAL FOR MODIFICATION TO THE SUREPATH SLIDE PREPARATION METHOD WHICH WILL BE MARKETED UNDER THE TRADE NAME PREPSTAIN SYSTEM AND IS INDICATED FOR USE AS A LIQUID-BASED THIN LAYER CELL PREPARATION PROCESS.  THE PRESTAIN SYSTEM PRODUCES SUREPATH SLIDES THAT ARE INTENDED AS REPLACEMENTS FOR CONVENTIONAL GYNECOLOGIC PAP SMEARS.  SUREPATH SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER, PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES.
P980016|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/12/2005|06/14/2005|||APPR|APPROVAL FOR THE MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND THE MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT ARE INDICATED FOR USE IN ICD PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  THE ENTRUST MODELS D153DRG, D153VRC AND D154 DRG ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  THE ENTRUST MODELS D153ATG AND D1534ATG ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  IN ADDITION, THE DEVICE IS INTENDED TO PROVIDE PACING, CARDIOVERSION, AND DEFIBRILLATION FOR TREATMENT OF PATIENTS WITH: 1) SYMPTOMATIC, DRUG-REFRACTORY ATRIAL FIBRILLATION AND/OR 2) LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS.  ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP) AND POST MODE SWITCH OVERDRIVE (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND  ONE OR MORE OF THE ABOVE ICD INDICATIONS.  NOTES:  A) USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS.  B) THE EFFECTIVENESS OF HIGH FREQUENCY BURST PACING (ATRIAL-50HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17% , AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.85% IN THE VT/AT POPULATION STUDIED.  C) THE EFFECTIVENESS OF HIGH FREQUENCY BURST PACING (ATRIAL-50HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 11.7% , AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 18.2% IN THE AF ONLY POPULATION STUDIED.
P010012|S042|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL CRT-D MODEL H125|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2005|02/02/2005|||APPR|APPROVAL FOR HEADER ASSEMBLY CHANGES TO THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTAK RENEWAL CRT-D MODEL H135.
P870038|S005|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2005|07/20/2005|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF POLYETHYLENE  TETRAFLUOROETHYLENE (PTFE) THREAD, NAMELY W.L. GORE, AND FOR A CHANGE FROM MULTIFILAMENT PTFE THREAD TO MONOFILAMENT PTFE THREAD USED IN THE FINAL SEWING OF THE CLOTH TO COMPLETE THE SEWING RING OF THE STARR-EDWARDS SILASTIC BALL PROSTHESIS, MODELS 1260 & 6120.
P010029|S001|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|NUXFLEXXA (SODIUM HYALURONATE)|MOZ|OR|Normal 180 Day Track||N|01/13/2005|02/27/2006|||APPR|APPROVAL FOR 1) CHANGING THE STORAGE CONDITIONS SPECIFIED IN THE PRODUCT LABELING FROM, ?STORE IN A COLD DARK PLACE [2 ? 8 DEGREES C (36-46 DEGREES F)].  PROTECT FROM LIGHT.  DO NOT FREEZE?.  2) CHANGE THE SPECIFIED SHELF LIFE TIME IN THE LABELING FORM 3 YEARS (AT REFRIGERATED TEMPERATURES) TO 12 MONTHS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EUFLEXXA AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN.)
P010038|S009|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM|MYN|RA|Normal 180 Day Track No User Fee|Other Report|N|01/18/2005|03/07/2005|||APPR|APPROVAL FOR PRIVATE LABEL DISTRIBUTION (HOLOGIC, INC. TO DISTRIBUTE SECOND LOOK).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECURLOOK AND IS INDICATED FOR: THE SECURLOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS OF THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P900023|S043|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2005|03/11/2005|||APPR|APPROVAL FOR THE ADDITION OF FOUR NEW INFLOW CANNULAE (32/42 FR APICAL CANNULA WITH SIDE HOLES AND 32/42 FR APICAL CANNULA WITHOUT SIDE HOLES) FOR USE WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM.
P950027|S006|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN|MOZ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2005|07/19/2005|||APPR|APPROVAL FOR MODIFYING THE SPECIFICATIONS FOR THE ACTIVE INGREDIENT (SODIUM HYALURONATE) BY ELIMINATING THE ABNORMAL TOXICITY TEST AND REPLACING THE RABBIT PYROGEN TEST WITH THE BACTERIAL ENDOTOXINS TEST (LIMULUS AMOEBOCYTE LYSATE (LAL) TEST) AND MODIFYING THE SPECIFICATIONS FOR THE FINISHED PRODUCT TO REPLACE THE RABBIT PYROGEN TEST WITH THE LAL TEST.
P950014|S024|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTATRON|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/19/2005|02/23/2005|||APPR|APPROVAL TO CHANGE LOCATION BALLOON MATERIAL FROM LATEX TO SILICONE, TO CHANGE THE METHOD OF ATTACHING THE LOCATION BALLOON DUE TO THE NEW MATERIAL, AND TO REMOVE THE CURRENT LATEX SENSITIVITY CAUTION AND OTHER REFERENCES TO LATEX IN THE LABELING.
P970020|S046|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK CORONARY STENT SYSTEMS|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/2005|04/21/2005|||APPR|APPROVAL TO UPDATE THE IFU TO REVISE THE MRI STATEMENT.
P030010|S001|SIEMENS MEDICAL SOLUTION|51 VALLEY STREAM PKWY.||MALVERN|PA|19355||Full field digital,system,x-ray,mammographic|SIEMENS MAMMOMAT NOVATION FFDM SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/2005|07/07/2005|||APPR|APPROVAL TO CHANGE THE ACQUISITION WORKSTATION (AWS) FROM THE CURRENTLY APPROVED UNIX-BASED SUN WORKSTATION WITH SOLARIS 8 OPERATING SYSTEM TO A FUJITSU/SIEMENS M420PC WITH SYNGO OPERATING SYSTEM AND THE PROPOSED CHANGES ALLOWING THE SOFTWARE DRIVERS FOR THE DETECTOR INTERFACE (DRUL) TO BE WINDOWS XP BASED.
P890003|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE|DXY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2005|03/31/2005|||APPR|APPROVAL FOR THE MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR USE WITH THE INSYNC SENTRY MODEL 7297, INSYNC II PROTECT MODEL 7295, INSYNC MAXIMO MODEL 7303, ONYX VR MODEL 7290CX, INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P020014|S009|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/24/2005|07/12/2005|||APPR|APPROVAL FOR MODIFICATION OF DEVICE LABELING TO INCLUDE 4- AND 5-YEAR EFFECTIVENESS RESULTS AND OTHER LABELING CHANGES.
P000009|S014|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2005|04/28/2005|||APPR|APPROVAL FOR THE XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME XELOS DR-T ICD SYSTEM AND IS INDICATED TO PROVIDE  VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P030054|S005|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF & ATLAS + HF CRT-D SYSTEMS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2005|03/08/2005|||APPR|APPROVAL FOR MODEL 3307 V.4.8.3 AND MODEL 3307 V.4.8.4 PROGRAMMER SOFTWARE.
P880086|S102|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|SYCHRONY PULSE GENERATOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2005|03/08/2005|||APPR|APPROVAL FOR MODEL 3307 V.4.8.3 AND MODEL 3307 V.4.8.4 PROGRAMMER SOFTWARE.
P930038|S042|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2005|05/16/2005|||APPR|APPROVAL FOR AN ALTERNATIVE BACKUP DEPLOYMENT REST METHODOLOGY.
P910023|S076|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/25/2005|03/01/2005|||APPR|APPROVAL FOR THE EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR.
P920047|S026|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2005|02/28/2005|||APPR|APPROVAL FOR THE BLAZER II AND BLAZER II XP CATHETERS WITH MODIFIED STEERING WIRE SUBASSEMBLIES.
P020025|S010|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP CARDIAC ABLATION SYSTEM|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2005|02/28/2005|||APPR|APPROVAL FOR THE BLAZER II AND BLAZER II XP CATHETERS WITH MODIFIED STEERING WIRE SUBASSEMBLIES.
P020009|S019|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS, EXPRESS2 CORONARY STENT SYSTEM (MOMORAIL AND OVER-THE-WIRE)|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/2005|02/15/2005|||APPR|APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTIONS REGARDING APPROPRIATE METHODS TO BE USED WHEN A PHYSICIAN EXPERIENCES WITHDRAWAL RESISTANCE FOLLOWING STENT DEPLOYMENT AND BALLOON DEFLATION.
P030025|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/2005|02/15/2005|||APPR|APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTIONS REGARDING APPROPRIATE METHODS TO BE USED WHEN A PHYSICIAN EXPERIENCES WITHDRAWAL RESISTANCE FOLLOWING STENT DEPLOYMENT AND BALLOON DEFLATION.
P020004|S010|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2005|05/10/2005|||APPR|APPROVAL FOR THE ADDITION OF A NEW CLEANROOM AND CONTROLLED ENVIRONMENT AREA.
P980035|S041|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|AT500 DDDRP PACING SYSTEM (MODEL AT500) AND MODEL 9968 SOFTWARE POST-MARKET (RESPECT): ADDING THE ENRHYTHM MODEL P1501DR|DXY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|01/27/2005|06/20/2005|||APPR|APPROVAL TO ADD THE ENRHYTHM MODEL P1501DR TO THE POST-APPROVAL STUDY OF THE DEVICE.
P900060|S030|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTETIC HEART VALVE (CPHV)|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2005|04/08/2005|||APPR|APPROVAL FOR A CHANGE IN THE LOCK WIRE FABRICATION FOR THE CARBOMEDICS PROSTHETIC HEART VALVE.
P880081|S030|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/03/2005|02/04/2005|||APPR|APPROVAL TO MODIFY THE "INDICATIONS" STATEMENTS FOR ALL LEGALLY MARKETED IOLS UNDER THE ABOVE REFERENCED PMAS TO REFLECT ADULTS AS OPPOSED TO ADULTS OLDER THAN 60 YEARS OF AGE.
P970015|S031|SOFAMOR DANEK|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|INTER FIX TM THREADED FUSION DEVICE|MAX|OR|Normal 180 Day Track No User Fee|Other Report|N|01/28/2005|07/27/2005|||APPR|APPROVAL FOR THE POST APPROVAL STUDY.  THE DEVICE REMAINS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1.  DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES.  THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL.  INTER FIX IMPLANTS AND INTER FIX RP IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH.
P030006|S004|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2005|03/11/2005|||APPR|APPROVAL FOR A NEW INK TO BE USED TO MARK THE CATHETER COMPONENT OF THE DEVICE USING THE SAME PAD PRINTING PROCESS FOR APPLYING THESE MARKINGS.
P000054|S004|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/26/2005|04/20/2005|||APPR|APPROVAL FOR TWO CHANGES TO THE PROCESSING OF THE RHBMP-2 COMPONENT OF THE DEVICE - THE USE OF A NEW WORKING CELL BANK AND THE  USE OF A LONGER HOLD-TIME (<=120 HOURS AT 2-8 DEGREES C COMPARED TO THE CURRENT 24 HOURS) FOR THE MATREX CELLUFINE SULFATE COLUMN.
P860004|S067|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/31/2005|03/02/2005|||APPR|APPROVAL FOR CHANGES TO THE WARNING STATEMENTS OF THE TECHNICAL MANUALS FOR BOTH THE SYNCHROMED EL AND SYNCHROMED II PROGRAMMABLE INFUSION PUMPS.
P980049|S018|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ELA MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2005|02/28/2005|||OK30|CHANGE IN STERILIZATION PROCESS PARAMETERS.
P980016|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INSYNC MAXIMO MODEL 7303 ONYX VR|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2005|03/31/2005|||APPR|APPROVAL FOR THE MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR USE WITH THE INSYNC SENTRY MODEL 7297, INSYNC II PROTECT MODEL 7295, INSYNC MAXIMO MODEL 7303, ONYX VR MODEL 7290CX, INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P020022|S002|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|01/31/2005|03/25/2005|||APPR|APPROVAL FOR ADDITION OF LABORATORY INFORMATION SYSTEM INTERFACE (VERSION 1.0) TO THE BAYER SYSTEM 340 BDNA ANALYZER DMS.
P950029|S023|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|ELA MEDICAL RATE-RESPONSIVE PACEMAKERS|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2005|02/28/2005|||OK30|CHANGE IN STERILIZATION PROCESS PARAMETERS.
P010031|S019|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES|NIK|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2005|03/31/2005|||APPR|APPROVAL FOR THE MODELS 2490G AND 2490J CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR USE WITH THE INSYNC SENTRY MODEL 7297, INSYNC II PROTECT MODEL 7295, INSYNC MAXIMO MODEL 7303, ONYX VR MODEL 7290CX, INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 IMPLANTABLE DEVICES.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P980003|S014|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2005|03/01/2005|||OK30|CHANGES TO THE SOLDER AND ADHESIVE APPLICATION PROCESSES.
P020050|S002|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/31/2005|02/15/2005|||APPR|APPROVAL FOR NOTEBOOK SOFTWARE CHANGES TO THE NEW SOFTWARE VERSION (NB-042201) THAT INVOLVE: 1) A CHANGE IN THE NOTATION USED TO ENTER REFRACTION; AND 2) THE SOFTWARE MENU LOCATION AT WHICH USERS MAY SELECT DIFFERENT VALUES FOR FLAP THICKNESS BASED ON THE TYPE OF MICROKERATOME USED TO CREATE CORNEAL FLAPS.
P030008|S002|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EXCIMER LASER SYSTEMS|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/31/2005|02/15/2005|||APPR|APPROVAL FOR NOTEBOOK SOFTWARE CHANGES TO THE NEW SOFTWARE VERSION (NB-042201) THAT INVOLVE: 1) A CHANGE IN THE NOTATION USED TO ENTER REFRACTION; AND 2) THE SOFTWARE MENU LOCATION AT WHICH USERS MAY SELECT DIFFERENT VALUES FOR FLAP THICKNESS BASED ON THE TYPE OF MICROKERATOME USED TO CREATE CORNEAL FLAPS.
P860057|S026|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700, 2700TFX 2800TFX|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2005|02/28/2005|||OK30|ADDITION OF AN ADDITIONAL SEMI-AUTOMATIC TORQUE MACHINE AND ASSOCIATED TOOLING.
P870077|S017|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSTHESIS, MODEL 6625LP AND 6625-ESR-LP|DYE|CV|30-Day Notice||N|01/31/2005|02/28/2005|||OK30|ADDITION OF AN ADDITIONAL SEMI-AUTOMATIC TORQUE MACHINE AND ASSOCIATED TOOLING.
P000007|S006|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P|DYE|CV|30-Day Notice||N|01/31/2005|02/28/2005|||OK30|ADDITION OF AN ADDITIONAL SEMI-AUTOMATIC TORQUE MACHINE AND ASSOCIATED TOOLING.
P010041|S006|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2005|02/28/2005|||OK30|ADDITION OF AN ADDITIONAL SEMI-AUTOMATIC TORQUE MACHINE AND ASSOCIATED TOOLING.
P870056|S019|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS, MODEL 2625, 6625 AND VALVED CONDUIT MODEL 4300|DYE|CV|30-Day Notice||N|01/31/2005|02/28/2005|||OK30|ADDITION OF AN ADDITIONAL SEMI-AUTOMATIC TORQUE MACHINE AND ASSOCIATED TOOLING.
P030030|S001|C.R. Bard, Inc.|13183 HARLAND DRIVE||COVINGTON|GA|30014|6421|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|TEGRESS URETHRAL IMPLANT|LNM|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/2005|02/09/2005|||APPR|APPROVAL FOR MODIFICATION OF THE LABELING TO REFLECT A NEW DEVICE TRADE NAME.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEGRESS URETHRAL IMPLANT AND IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).
P970008|S025|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2005|02/15/2005|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE DEVICE: 1) THE CHANGE OF THE INSERTION TIP AND ADHESIVE OF THE COOLED THERMOCATH MICROWAVE DELIVERY SYSTEM (CTC MDS) TO INCREASE TO THE FLEXIBILITY OF THE CATHETER; 2) THE CHANGE OF THE INSERTION TIP AND ADHESIVE OF THE TARGIS MICROWAVE DELIVERY SYSTEM TO THE SAME CATHETER TYPE AS THE CTC MDS; AND 3) THE ADDITION OF TEXIN 950 UV STABILIZED TUBING FOR THE SHAFT OF THE CTC CATHETER.
P860019|S202|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2|LOX|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2005|02/15/2005|||APPR|APPROVAL TO ADD A SPECIFICATION FOR ACCEPTABLE PYROGEN LEVEL TO THE HYPOTUBE COMPONENT.
P020009|S020|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2|MAF|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2005|02/15/2005|||APPR|APPROVAL TO ADD A SPECIFICATION FOR ACCEPTABLE PYROGEN LEVEL TO THE HYPOTUBE COMPONENT.
P030025|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PTCA BALLOON CATHETERS, EXPRESS2 CORONARY STENT SYSTEM AND TAXUS EXPRESS2|NIQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2005|02/15/2005|||APPR|APPROVAL TO ADD A SPECIFICATION FOR ACCEPTABLE PYROGEN LEVEL TO THE HYPOTUBE COMPONENT.
P980006|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENS|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2005|03/17/2005|||APPR|APPROVAL FOR THE TORIC DESIGN WITH AN EXTENDED WEAR INDICATION FOR UP TO 30 DAYS CONTINUOUS WEAR BETWEEN REMOVALS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB PURE VISION TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENS AND IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 5.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENS MAYBE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00 TO -9.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO -20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS.
P010021|S005|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|02/02/2005|02/11/2005|||APPR|APPROVAL FOR MODIFICATION OF RAW MATERIAL SPECIFICATION.
P000021|S005|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION TPSA FLEX REAGENT CARTRIDGE|LTJ|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2005|02/11/2005|||OK30|CHANGE TO DECREASE THE QUANTITY OF REJECTED PRODUCT.
P020027|S002|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2005|02/11/2005|||OK30|CHANGE TO DECREASE THE QUANTITY OF REJECTED PRODUCT.
P000058|S016|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPAERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2005|04/20/2005|||APPR|APPROVAL FOR A NEW REFERENCE STANDARD FOR THE RHBMP-2 COMPONENT.
P000054|S005|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2005|04/20/2005|||APPR|APPROVAL FOR A NEW REFERENCE STANDARD FOR THE RHBMP-2 COMPONENT.
P860004|S068|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/07/2005|03/10/2005|||APPR|APPROVAL FOR A TECHNICAL MANUAL ADDENDUM TO BE ADDED TO THE PACKAGED CATHETER KIT TO STRENGTHEN THE INSTRUCTIONS FOR THE PROPER USE OF THE CONNECTOR.
P000025|S018|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+/PULSAR COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2005|02/28/2005|||OK30|NEW SILICONE SUPPLIER.
P020008|S001|KARL STORZ ENDOSCOPY-AMERICA, INC.|600 CORPORATE POINTE||CULVER CITY|CA|90230|7600|SYSTEM, IMAGING, FLUORESCENCE|KARL STORZ AUTOFLURESCENCE SYSTEM|MRK|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2005|03/04/2005|||OK30|CHANGE IN THE OEM SENSOR FOR THE KARL STORZ AUTOFLUORESCENCE SYSTEM.
P930038|S043|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2005|05/12/2005|||APPR|APPROVAL FOR CHANGING THE LOT RELEASE SAMPLING PLAN AND PERFORMANCE SPECIFICATION.
P810031|S026|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON SODIUM HYALURONATE VISCELASTIC PRODUCTS, HEALON,HEALON GV, HEALON 5|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2005|03/04/2005|||OK30|CHANGE IN VENDOR OF A RAW MATERIAL FOR HEALON PRODUCTS.
P020023|S011|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/2005|03/11/2005|||APPR|APPROVAL FOR CHANGES IN PRODUCT LABELING.
P960052|S010|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE|MPN|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2005|03/21/2005|||APPR|APPROVAL FOR THE ADDITION OF PROPEN AND PROPEN XL APPLICATORS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES HIGH VISCOSITY DERMABOND PROPEN TOPICAL ADHESIVE AND HIGH VISCOSITY DERMABOND PROPEN XL TOPICAL SKIN ADHESIVE PRODUCTS AND ARE INDICATED FOR TOPICAL APPLICATION TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF WOUNDS FROM SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS. HIGH VISCOSITY DERMABOND PROPEN AND PROPEN XL MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF SUBCUTICULAR SUTURES.  DERMABOND ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF DEEP DERMAL STITCHES.
P950039|S014|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2005|03/18/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORPORATION, MARLBOROUGH, MASSACHUSETTS.
P020045|S007|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2005|03/29/2005|||APPR|APPROVAL FOR A MODIFICATION FROM TEMPERATURE TO FLOW CONTROL IN CRYOABLATION MODE OF THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE.
P030034|S001|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL-STIM CERVICAL FUSION SYSTEM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2005|05/16/2005|||APPR|
P980022|S012|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN RT|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/2005|08/24/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE SENSOR TO INCLUDE THE USE OF HUMAN SERUM ALBUMIN IN PLACE OF BOVINE SERUM ALBUMIN AS A STABILIZER AND A CHANGE TO THE MANUFACTURING PROCESS REMOVING THE OUTER HYDROPHILIC MEMBRANE.
P990071|S006|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR|DRF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/17/2005|03/21/2005|N||APPR|APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE  INSTRUCTIONS FOR USE.
P990001|S017|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWA|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2005|03/16/2005|||APPR|APPROVAL FOR THE VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWARE (VSF11/VSF12 VERSION 1.0); AND THE T-SERIES APPLICATION SOFTWARE (VSF07/VSF08 VERSION 1.2); AND CD-ROM (VSE03/VSE04 VERSION 2.3).
P880086|S103|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2005|04/06/2005|||APPR|APPROVAL FOR PRE-MOLDED HEADER DESIGN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380, IDENTITY ADX VDR MODEL 5480, AND INTEGRITY ADX DR MODEL 5360.
P040006|S002|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|CHARITE ARTIFICIAL DISC|MJO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2005|03/29/2006|||APPR|APPROVAL FOR 1) NEW ENDPLATES COATED WITH VACUUM PLASMA-SPRAYED PURE TITANIUM AND CALCIUM PHOSPHATE; 2) THREE NEW INTERMEDIATE ENDPLATE SIZES UTILIZING THIS SAME COATING; AND 3) VARIOUS SURGICAL INSTRUMENTS TO ACCOMMODATE THE PROPOSED NEW ENDPLATES.
P000058|S017|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE-GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2005|03/11/2005|||APPR|APPROVAL FOR USE OF NEW SHIPPING CONTAINER.  THE NEW CONTAINER IS LIGHTER THAN THE CURRENT CONTAINER AND USES POLYSTYRENE INSULATION INSTEAD OF POLYURETHANE.
P000054|S006|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2005|03/11/2005|||APPR|APPROVAL FOR USE OF NEW SHIPPING CONTAINER.  THE NEW CONTAINER IS LIGHTER THAN THE CURRENT CONTAINER AND USES POLYSTYRENE INSULATION INSTEAD OF POLYURETHANE.
P010032|S016|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS DUAL 4-CHANNEL IMPLANTABLE PULSE GENERATOR (IPG)|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2005|05/05/2005|||APPR|APPROVAL FOR THE GENESIS DUAL 4-CHANNEL IMPLANTABLE PULSE GENERATOR (IPG), MODEL 3643 WHICH IS INDICATED AS AN AID IN THE MANAGEMENT  OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P910073|S050|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK FAMILY INCLUDES ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2005|03/24/2005|||OK30|CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
P950001|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE FAMILY (INCLUDES SELUTE, SELUTE PICOTIP)|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2005|03/24/2005|||OK30|CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
P000032|S006|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2005|03/21/2005|||OK30|ADDITION OF A NEW TYPE OF FILTER TO THE CRYOSTAT, A CHANGE TO ENHANCE THE CORROSION RESISTANCE OF THE CRYOSTAT TUBING AND A CHANGE IN THE CRYOSTAT CLEANING METHOD.
P960004|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FINELINE FAMILY INCLUDES FINELINE, FINELINE II|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2005|03/24/2005|||OK30|CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
P960006|S014|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SWEET TIP RX FAMILY INCLUDING SWEET TIP RX, SWEET PICOTIP RX FLEXTEND FAMILY|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2005|03/24/2005|||OK30|CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
P010012|S043|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK FAMILY INCLUDES EASYTRAK, EASYTRAK 2, EASYTRAK 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2005|03/24/2005|||OK30|CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
P970008|S026|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/2005|06/16/2005|||APPR|APPROVAL FOR A LONGER VERSION OF THE COOLED THERMOCATH MICROWAVE DELIVERY CATHETER.  THE LONGER ANTENNA IS 37 MM COMPARED TO THE 28 MM ANTENNA IN THE CURRENTLY APPROVED COOLED THERMOCATH CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLED THERMOCATH 4.5+ AND IS INDICATED FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 4.5 CM OR GREATER.
P010018|S007|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CONDUCTIVE KERATOPLASTY SYSTEM|MWD|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2005|03/22/2005|||OK30|ALTERNATE MANUFACTURING METHOD FOR THE TROCAR AND STOP SUBASSEMBLY OF THE DISPOSABLE KERATOPLAST TIP.
P000014|S011|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HB REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2005|03/29/2005|||OK30|CHANGE TO THE TEST AND RELEASE LIMIT THAT IS APPLIED TO THE DOSE-RESPONSE CURVE SHAPE PARAMETERS.
P030054|S006|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC, EPIC+, AND EPIC HE ICD SYSTEMS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/02/2005|03/30/2005|||APPR|APPROVAL FOR A NEW CAPACITOR USED IN THE EPIC, EPIC+, AND EPIC HE ICD SYSTEMS.
P990019|S003|DUSA PHARMACEUTICALS, INC.|25 UPTON DR.||WILMINGTON|MA|01887||SYSTEM, LASER, PHOTODYNAMIC THERAPY|BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170|MVF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2005|10/06/2005|||APPR|APPROVAL OF AN ALTERNATE MANUFACTURING SITE LOCATED AT DUSA PHARMACEUTICALS, INC., WILMINGTON, MASSACHUSETTS.
P980006|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES-THERAPEUTIC USE|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/2005|05/27/2005|||APPR|APPROVAL FOR ADDING A THERAPEUTIC INDICATION FOR THE PUREVISION CONTACT LENS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS FOR THERAPEUTIC USE AND IS INDICATED FOR THERAPEUTIC USE AS A BANDAGE CONTACT LENS FOR CORNEAL PROTECTION AND CORNEAL PAIN RELIEF DURING TREATMENT OF OCULAR PATHOLOGIES AS WELL AS POST-SURGICAL CONDITIONS.  APPLICATIONS OF THE PUREVISION CONTACT LENS INCLUDE BUT ARE NOT LIMITED TO CONDITIONS SUCH AS THE FOLLOWING: 1) FOR CORNEAL PROTECTION IN CONDITIONS SUCH AS ENTROPION, TRICHIASIS, TARSAL SCARS, RECURRENT CORNEAL EROSION AND POST SURGICAL PTOSIS FOR CORNEAL PROTECTION; 2) FOR CORNEAL PAIN RELIEF IN CONDITIONS SUCH AS BULLOUS KERATOPATHY, EPITHELIAL EROSION AND ABRASION, FILAMENTARY KERATITIS, POST-KERATOPLASTY; 3) FOR USE AS A BANDAGE DURING THE HEALING PROCESS OF CONDITIONS SUCH AS CHRONIC EPITHELIAL DEFECTS, CORNEAL ULCER, NEUROTROPHIC KERATITIS, NEUROPARALYTIC KERATITIS, CHEMICAL BURNS, AND POST SURGICAL EPITHELIAL DEFECTS; AND 4) FOR POST SURGICAL CONDITIONS THAT INCLUDE BANDAGE USE SUCH AS LASIK, PRK, PK, PTK, LAMELLAR GRAFTS, CORNEAL FLAPS, AND ADDITIONAL CORNEAL SURGICAL CONDITIONS.  PURE VISION CONTACT LENSES FOR THERAPEUTIC USE CAN ALSO PROVIDE CORRECTION DURING HEALING IF REQUIRED.
P910077|S050|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE...|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/2005|08/15/2005|||APPR|APPROVAL FOR THE ADDITION OF A SECOND INTERNAL ANTENNA TO THE MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR, A LABELING UPDATE FOR THE MODEL 3122 ANTENNA ACCESSORY, CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12, AND MINOR MANUFACTURING PROCESS CHANGES.
P990053|S012|NELLCOR PURITAN BENNETT, INC.|4280 HACIENDA DR.||PLEASANTON|CA|94588|2719|OXIMETER, FETAL PULSE|OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM|MMA|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2005|06/24/2005|||APPR|APPROVAL FOR AN ALTERNATIVE VENDOR OF RAW CABLE AND FETAL SENSOR CABLE WITHIN THE OXIMETRY SENSOR.
P010012|S044|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 RF CRT-D SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/2005|08/15/2005|||APPR|APPROVAL FOR CONTAK RENEWAL 3 RF PULSE GENERATOR SOFTWARE VERSION 1.2 AND CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12.  ALSO APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
P940040|S005|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST|MWA|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2005|04/22/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMMERVILLE, NEW JERSEY, FOR KIT PACKAGING AND STAGING ACTIVITIES.
P000010|S004|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV, TEST VERSION 2.0|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2005|04/22/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMMERVILLE, NEW JERSEY, FOR KIT PACKAGING AND STAGING ACTIVITIES.
P000012|S005|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2005|04/22/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMMERVILLE, NEW JERSEY, FOR KIT PACKAGING AND STAGING ACTIVITIES.
P810044|S005|DIABETES SENTRY PRODUCTS, LLC|501 Samuels Ave.|Unit #110|Fort Worth|TX|76102||MONITOR, SKIN RESISTANCE/SKIN TEMPERATURE,  FOR INSULIN REACTIONS|DIABETES SENTRY|LMY|HO|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/28/2005|04/08/2005|||APPR|APPROVAL FOR THE CHANGE OF THE DEVICE WEB ADDRESS, AND A CHANGE TO THE NAME OF THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIABETES SENTRY.
P870025|S007|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR|MCP|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2005|03/24/2005|||OK30|CHANGE IN MANUFACTURER FOR THE PLASTIC HOUSING.
P860004|S069|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2005|04/07/2005|||APPR|APPROVAL FOR THE PUMP HEAD COVER ASSEMBLY MODIFICATIONS, ROLLER ARM AND SUPPORT ASSEMBLY MODIFICATIONS AND SHAFT ASSEMBLY MODIFICATIONS.
P930016|S021|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/2005|08/30/2005|05M-0382|09/23/2005|APPR|APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM.  THE DEVICE USES A 6.0 MM OPTICAL ZONE, AN 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA AND MYOPIC ASTIGMATISM FROM -6.0 TO -11.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER, AND 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 1.00 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.
P970051|S030|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2005|03/30/2005|||OK30|CHANGE OF SUPPLIER FOR THREE SILICONE PRODUCTS (SILICONE HCRP 50, SILICONE LSR 30, AND RTV SILICONE ADHESIVE) AND CHANGE THE CATALYST IN TWO ADDITIONAL SILICONE PRODUCTS (MED4515 & MED4516).
P000015|S006|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2005|03/30/2005|||OK30|CHANGE OF SUPPLIER FOR THREE SILICONE PRODUCTS (SILICONE HCRP 50, SILICONE LSR 30, AND RTV SILICONE ADHESIVE) AND CHANGE THE CATALYST IN TWO ADDITIONAL SILICONE PRODUCTS (MED4515 & MED4516).
P030017|S006|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2005|04/08/2005|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE SUPPLIER OF THE PRECISION SYSTEM LEAD AND LEAD EXTENSIONS.
P960009|S032|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2005|04/27/2005|||OK30|MODIFICATION FOR THE EPOXY DISPERSE PATTERN OF THE WIRE BOND.
P990004|S008|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFLO HEMOSTATIC MATRIX|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/2005|05/05/2005|||APPR|APPROVAL FOR MARKETING A PRE-FILLED PASTE PREPARED FROM THE POWDERED FORM OF THE ABSORBABLE GELATIN SPONGE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFLO HEMOSTATIC MATRIX AND IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT UROLOGIC AND OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P990080|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/14/2005|04/13/2005|||APPR|APPROVAL FOR THE TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS MODEL ZA9003 WITH CLAIMS REGARDING REDUCTION IN POSTOPERATIVE SPHERICAL ABERRATIONS COMPARED TO LENSES WITH SPHERICAL OPTICS AND IMPROVED NIGHT DRIVING SIMULATOR PERFORMANCE.
P970055|S002|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|MYM|MI|30-Day Notice||N|03/23/2005|04/01/2005|||OK30|
P970054|S002|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY|MYL|MI|30-Day Notice||N|03/23/2005|04/01/2005|||OK30|
P970051|S031|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|03/15/2005|04/13/2005|||APPR|APPROVAL FOR AN OPTIONAL BODY-WORN BATTERY PACK AND CONTROLLER (BWBP) FOR USE WITH THE SP12 SPEECH PROCESSOR.
P910077|S051|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/15/2005|09/08/2005|||APPR|APPROVAL FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM INCLUDING THE MODEL 6482 LATITUDE COMMUNICATOR V1.4 AND THE SUPPLEMENTAL APPLICATION SERVER (SAS) SOFTWARE V1.0.1 FOR USE IN MONITORING PATIENTS IMPLANTED WITH A CONTAK RENEWAL 3 RF.
P980003|S015|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/2005|05/20/2005|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM SIX (6) MONTHS TO ON (1) YEAR; AND, PACKAGING CHANGES FOR THE CHILLI II ABLATION CATHETER.
P010012|S045|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD2, CONTAK RENEWAL/RENEWAL 3/ RENEWAL 3/3HE RF|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2005|04/08/2005|||APPR|APPROVAL FOR THE USE OF A LUBRICANT, MED-420 ON SEAL PLUGS OF THE HEART FAILURE, TACHY AND BRADY DEVICES.
P930014|S015|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SA60T3, SA60T4 AND SA60T5|HQL|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/18/2005|09/14/2005|05M-0378|09/23/2005|APPR|APPROVAL FOR THE ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SA60T3, SA60T4 AND SA60T5.  THE DEVICES ARE INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION OF RESIDUAL REFRACTIVE CYLINDER AND INCREASED SPECTACLE INDEPENDENCE FOR DISTANCE VISION.
P030005|S008|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2005|04/08/2005|||APPR|APPROVAL FOR THE USE OF A LUBRICANT, MED-420 ON SEAL PLUGS OF THE HEART FAILURE, TACHY AND BRADY DEVICES.
P960040|S052|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY DEVICES & VENTAK PRISM DEVICES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2005|04/08/2005|||APPR|APPROVAL FOR THE USE OF A LUBRICANT, MED-420 ON SEAL PLUGS OF THE HEART FAILURE, TACHY AND BRADY DEVICES.
P940031|S034|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY & MERIDIAN DEVICE|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2005|04/08/2005|||APPR|APPROVAL FOR THE USE OF A LUBRICANT, MED-420 ON SEAL PLUGS OF THE HEART FAILURE, TACHY AND BRADY DEVICES.
P000009|S015|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2005|06/22/2005|||APPR|APPROVAL FOR THE IMPLANT CONTROL SYSTEM (ICS) 3000 PROGRAMMING SYSTEM, USING SOFTWARE VERSION 501.U FOR USE WITH THE BELOS, CARDIAC AIRBAG, LEXOS, AND XELOS FAMILIES OF ICDS.
P010012|S046|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2005|04/14/2005|||OK30|HYBRID FABRICATION TO ALSO BE PERFORMED IN CLONMEL, IRELAND.
P860019|S203|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P860057|S027|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODEL 2700, 2700TFX, 2800TFX, 3000, 3000TFX, 6900, 6900P PERIMOUN|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2005|04/08/2005|||OK30|CHANGE TO THE SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) YARN AND THREAD.
P980033|S013|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (VENOUS)|MAF|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P980009|S013|BOSTON SCIENTIFIC SCIMED, INC.|TWO SCIMED PLACE||MAPLE GROVE|MN|||STENT, CORONARY|MAGIC WALLSTENT ENDOPROSTHESIS|MAF|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P870077|S018|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSOTHESIS MODELS 6625LP AND 6625-ESR LP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2005|04/08/2005|||OK30|CHANGE TO THE SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) YARN AND THREAD.
P020009|S021|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P030025|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P880027|S064|BOSTON SCIENTIFIC|One Scimed Place||Maple Grove|MN|55311||Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P930031|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (TIPS)|MIR|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P940019|S019|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (ILIAC)|MAF|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P970061|S021|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|RADIUS CORONARY STENT WITH DELIVERY SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/14/2005|10/31/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS.  THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS.
P000007|S007|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2005|04/08/2005|||OK30|CHANGE TO THE SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) YARN AND THREAD.
P010041|S007|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2005|04/08/2005|||OK30|CHANGE TO THE SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) YARN AND THREAD.
P870056|S020|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS MODELS 2625,6625, VALVED CONDUIT MODEL 4300|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2005|04/08/2005|||OK30|CHANGE TO THE SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) YARN AND THREAD.
P030006|S005|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER|MEQ|GU|Normal 180 Day Track No User Fee|Express GMP Supplement|N|03/23/2005|06/30/2005|||APPR|APPROVAL FOR ACCELLENT JUAREZ (MANUFACTURING SITE) LOCATED IN, CHIHUAHUA, MEXICO; ACCELLENT EL PASO (WAREHOUSE) LOCATED IN EL PASO, TEXAS; AND STERIGENICS INTERNATIONAL, INC. (STERILIZER) LOCATED IN SANTA TERESA, NEW MEXICO.
P000037|S004|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2005|05/04/2005|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO INCLUDE AN ADDITIONAL STANDARD LEAFLET INSPECTION STEP FOR REWORKED PRODUCT WITH UNACCEPTABLY HIGH LEAK TEST RESULT.
P030025|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2005|07/08/2005|||APPR|APPROVAL TO CHANGE THE IN-PROCESS COATING WEIGHT ACCEPTANCE CRITERIA.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >=2.5 TO <=3.75 MM IN DIAMETER.
P950022|S019|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA DEFIBRILLATION LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2005|05/16/2005|||APPR|APPROVAL FOR CHANGES TO THE STYLET RING AND THE LEAD HEADER COUPLING.
P960040|S053|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE MODEL T180 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2005|05/18/2005|||APPR|APPROVAL FOR THE VITALITY HE MODEL T180 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2896 VERSION 1.0.  THE DEVICE IS INDICATED AS FOLLOWS:  GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
P000020|S009|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER, STINGER S, STINGER M, & STINGER SM ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2005|06/16/2005|||APPR|APPROVAL FOR PACKAGING CHANGES FOR THE BARD STINGER, STINGER S, STINGER M, AND STINGER SM ABLATION CATHETER.
P810046|S219|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER RX CORONARY DILATATION CATHETER|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2005|04/26/2005|||OK30|CHANGE IN THE TRIMMING PROCESS OF THE INNER MEMBER OF THE CATHETER.
P930016|S022|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SOFTWARE, VERSION 5.10|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2005|05/02/2005|||APPR|APPROVAL FOR SOFTWARE AND LABELING CHANGES REGARDING THE IRIS REGISTRATION FUNCTIONALITY OF THE DEVICE.
P030025|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2005|04/13/2005|||OK30|ALTERNATIVE ANALYTICAL METHOD TO BE USED FOR THE NON-COMPENDIAL FUNCTIONAL EXCIPIENT ANALYSIS OF POLY (STYRENE-ISOBUTYLENE-STYRENE) TRI-BLOCK COPOLYMER, SIBS IN THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM.
P010031|S020|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2005|07/26/2005|||APPR|APPROVAL FOR THE MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE FOR USE IN THE TRANSFER OF PATIENT AND DEVICE DATA.
P980016|S048|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2005|07/26/2005|||APPR|APPROVAL FOR THE MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE FOR USE IN THE TRANSFER OF PATIENT AND DEVICE DATA.
P890003|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|2020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2005|07/26/2005|||APPR|APPROVAL FOR THE MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE FOR USE IN THE TRANSFER OF PATIENT AND DEVICE DATA.
P970003|S057|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM, MODEL 250 PROGRAMMING SOFTWARE SOFTWARE VERSION 7.0 INSTRUCTION CARD|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2005|04/29/2005|||APPR|APPROVAL FOR TEXT CHANGES TO THE PRINTED INSTRUCTION CARD.
P000032|S008|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2005|04/22/2005|||OK30|CHANGE IN THE JOINING OPERATIONS FOR THE HER OPTION CRYOABLATION THERAPY SYSTEM.
P860004|S070|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2005|09/26/2005|||APPR|APPROVAL FOR THE MODEL 8832 PERSONAL THERAPY MANAGER (PTM), AN ACCESSORY TO THE SYNCHROMED II IMPLANTABLE INFUSION SYSTEM, INDICATED FOR THE PATIENT TO ACTIVATE DELIVERY OF PHYSICIAN PROGRAMMED SUPPLEMENTAL DOSES OF PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION FROM THE SYNCHROMED II PUMP FOR THE TREATMENT OF CHRONIC INTRACTABLE PAIN.
P040014|S001|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|IBI CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/2005|01/20/2006|||APPR|APPROVAL FOR THE IBI THERAPY ABLATION CATHETER (4 MM TIP) TO BE USED WITH THE 1711-M CABLE WHICH CONNECTS THE IBI THERAPY ABLATION CATHETER TO THE MEDTRONIC CARDIO RHYTHM ATAKR GENERATOR AS WELL AS FOR THE IBI THERAPY ABLATION CATHETER (4 MM TIP) TO BE USED WITH THE 1713-W CABLE WHICH CONNECTS THE IBI THERAPY ABLATION CATHETER TO THE BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR.
P950039|S015|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Normal 180 Day Track||N|04/01/2005|09/28/2005|||APPR|APPROVAL FOR ADDITIONAL CLAIMS TO THE CURRENT APPROVED LABELING FOR THINPREP 2000 SYSTEM REGARDING REMOVAL OF A 4 ML ALIQUOT FROM THE PRESERVCYT VIAL PRIOR TO PREPARATION OF THE THINPREP PAP TEST(TPPT). THIS ALIQUOT IS ONLY TO BE USED TO SUPPORT PERFORMANCE OF ANCILLARY TESTS APPROVED BY THE FDA ON PRESERVCYT MATERIAL.
P020050|S003|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EYE-Q LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/2005|06/16/2006|||APPR|APPROVAL FOR A CHANGE IN REPETITION RATE FROM 200 HZ TO 400 HZ.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER:  1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO -12.0 DIOPTERS (D) OF SPHERE AND UP TO -6.0 D OF ASTIGMATISM AT THE SPECTACLE PLANE IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 2) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 D OF SPHERE WITH AND WITHOUT ASTIGMATIC REFRACTIVE ERRORS UP TO 5.0 D AT THE SPECTACLE PLANE, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY, EXCLUSIVE OF CHANGES DUE TO UNMASKING LATENT HYPEROPIA.
P020027|S003|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|04/01/2005|06/02/2005|||APPR|APPROVAL FOR THE ADDITION OF THE STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE TO THE DIMENSION RXL MAX.
P000021|S006|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION TPSA FLEX REAGENT CARTRIDGE|LTJ|IM|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|04/01/2005|06/02/2005|||APPR|APPROVAL FOR THE ADDITION OF THE STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE TO THE DIMENSION RXL MAX.
P030008|S003|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/2005|06/16/2006|||APPR|APPROVAL FOR A CHANGE IN REPETITION RATE FROM 200 HZ TO 400 HZ.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER:  1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO -12.0 DIOPTERS (D) OF SPHERE AND UP TO -6.0 D OF ASTIGMATISM AT THE SPECTACLE PLANE IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 2) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 D OF SPHERE WITH AND WITHOUT ASTIGMATIC REFRACTIVE ERRORS UP TO 5.0 D AT THE SPECTACLE PLANE, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY, EXCLUSIVE OF CHANGES DUE TO UNMASKING LATENT HYPEROPIA.
P950032|S040|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2005|04/25/2005|||OK30|CHANGES TO THE FORMULATION OF THE TRYPSIN QUENCHING SOLUTION USED IN THE APLIGRAF MANUFACTURING PROCESS.
P950022|S020|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF DEFIBRILLATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2005|05/05/2005|||OK30|DIMENSIONAL CHANGES TO THE RIATA LEADS.
P950022|S021|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF DEFIBRILLATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2005|05/05/2005|||OK30|CHANGE FROM WELDING TO CRIMPING CONNECTORS.
P950022|S022|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF DEFIBRILLATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2005|05/05/2005|||OK30|CHANGE FROM MANUAL TO AUTOMATED PROCESSING.
P950022|S023|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF DEFIBRILLATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2005|05/05/2005|||OK30|CHANGE IN THE ORDER OF MANUFACTURING STEPS FOR THE CRIMPING PROCESS.
P860004|S071|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED II IMPLANTABLE INFUSION PUMP SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2005|04/29/2005|||OK30|CHANGES TO THE HYBRID TEST SUITE TO ADD A MARCHING RAM TEST FOR THE MICROPROCESSOR'S ONBOARD RAM.
P840064|S027|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/05/2005|04/12/2005|||APPR|APPROVAL FOR THE ADDITION OF A 1.0 ML FILL SIZE TO THE PRODUCT LINE.
P990046|S014|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS MEDIAL HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2005|01/17/2006|||APPR|APPROVAL FOR A NEW VENDOR FOR THE LEAFLET SUBSTRATE COMPONENT.
P030026|S005|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2005|04/15/2005|||OK30|MODIFICATION IN TESTING OF INCOMING MATERIAL.
P970008|S027|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/07/2005|04/29/2005|||APPR|APPROVAL FOR UPGRADING A TARGIS CONTROL BOARD (LUXTRON SUB-ASSEMBLY).
P000029|S012|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|04/08/2005|08/02/2005|||APPR|APPROVAL FOR MODIFICATION OF THE POST APPROVAL STUDY PROTOCOL TO: 1) REPLACE THE 1- AND 5-YEAR VOIDING CYSTOURETHROGRAM MEASUREMENTS WITH CLINICAL ASSESSMENTS OF "FEBRILE UTI;" AND 2) DECREASE THE TOTAL SAMPLE SIZE FROM 200 TO 149 PATIENTS.
P000044|S006|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR AND THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIR|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2005|05/05/2005|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS WHICH ADD AN INCOMING RAW MATERIAL TEST.
P030024|S003|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2005|05/05/2005|||APPR|APPROVAL FOR THE ADDITION OF AN INCOMING RAW MATERIAL TEST.
P900056|S083|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTAWIRE GUIDE WIRE, A COMPONENT OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2005|09/27/2005|||APPR|APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC. (FORMERLY COSMED STERILIZATION GROUP OF NEW JERSEY), SOUTH PLAINFIELD, NEW JERSEY.
P990071|S007|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/11/2005|07/12/2005|||APPR|APPROVAL FOR REPLACING SOFTWARE VERSION 1.034B WITH VERSION 1.035.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STOCKERT 70 RF GENERATOR FOR CARDIAC ABLATION AND IS INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES.
P910023|S077|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ICD FIRMWARE VERSION 6.6.7 FOR EPIC, EPIC +, ATLAS AND ATLAS +, AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/12/2005|06/17/2005|||APPR|APPROVAL FOR THE ICD FIRMWARE VERSION 6.6.7 FOR EPIC MODELS V-233, V-239, V-239T, V-196, V-196T, V-338, V-337, EPIC PLUS MODELS V-236, V-196, ATLAS AND ATLAS PLUS MODELS V-242, V243, V-193, V-193C, V340, V-343; AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5.
P030054|S007|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS AND ATLAS+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/12/2005|06/17/2005|||APPR|APPROVAL FOR THE ICD FIRMWARE VERSION 6.6.7 FOR EPIC MODELS V-233, V-239, V-239T, V-196, V-196T, V-338, V-337, EPIC PLUS MODELS V-236, V-196, ATLAS AND ATLAS PLUS MODELS V-242, V243, V-193, V-193C, V340, V-343; AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5.
P960006|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FLEXTEND LEADS, MODELS 4086, 4087, AND 4088|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2005|05/06/2005|||OK30|CHANGE OF SILICONE ADHESIVE.
P980049|S019|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALTO SHOCK 4 MODULES|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2005|05/13/2005|||OK30|CHANGES TO THE MANUFACTURING PROCESS AT INTERNATIONAL RECTIFIER, LEOMINSTER, MASSACHUSETTS AND THALES, NEUILLY-SUR-SEINE, FRANCE.  THE MODIFICATIONS INCLUDE: 1) CHANGING THE EPOXY RESIN FOR ENCAPSULATION 2) REMOVING THE PARYLENE COATING 3) CHANGING THE PHOTOCOUPLER AND DISCHARGE CIRCUITS FORM SEPARATE COMPONENTS TO A SINGLE COMPONENT COATED WITH EPOXY 4) CHANGING THE EPOXY FOR ATTACHING THE TRANSFORMER, AND 5) ADDING A SILICONE COVER OVER CERTAIN CAPACITORS PRIOR TO THE FINAL ASSEMBLY PROCESS.
P950014|S025|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX PROSTATRON SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2005|05/25/2005|||APPR|APPROVAL TO MODIFY A VOLTAGE TOLERANCE SETTING AND TO REPLACE THE CURRENT SOFTWARE WITH ITS PREVIOUSLY APPROVED VERSION.
P910023|S078|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1)|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2005|05/24/2005|||APPR|APPROVAL FOR THE SOFTWARE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS RECEIVER SOFTWARE (VERSION 2.1).
P010003|S005|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2005|01/20/2006|||APPR|APPROVAL FOR: 1) ADDITION OF TWO SPREADER TIPS, SIZE 12 MM AND 16 MM; 2) ADDITION OF A GREEN COLORANT (FDA 21 CFR 178.3297 COMPLIANT MBPP 11962) TO THE COLLAR OF THE MIXING TIP FOR EASIER VISUALIZATION OF THE MATING MECHANISM; 3) MODIFICATION (BLUNTING THE END RATHER THAN POINTED TIP) OF THE MIXING CHAMBER STEM END TO ACCEPT THE NEW APPLICATOR TIPS; 4) MODIFICATION OF THE COLLAR FORMULATION FOR THE POLYPROPYLENE; 5) USE OF A NEW MATERIAL FOR THE SPREADER EXTENSION; AND 6) MODIFICATION OF THE STEM MATERIAL.
P890003|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITORS, MODELS 2490G AND 2490J|NVZ|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|04/15/2005|01/24/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA, FOR THE FINAL TESTING, LABELING AND PACKAGING OF THE DEVICE.
P980016|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CARELINK MONITORS, MODELS 2490G AND 2490J|LWS|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|04/15/2005|01/24/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA, FOR THE FINAL TESTING, LABELING AND PACKAGING OF THE DEVICE.
P010031|S022|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CARELINK MONITORS, MODELS 2490G AND 2490J|NIK|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|04/15/2005|01/24/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA, FOR THE FINAL TESTING, LABELING AND PACKAGING OF THE DEVICE.
P040043|S001|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2005|05/10/2005|||OK30|ADDITION OF A NEW CLEANROOM AND CONTROLLED ENVIRONMENT AREA.
P030054|S008|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MERLIN PATIENT CARE SYSTEM MODEL 3650|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2005|10/12/2005|||APPR|APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM WITH THE MODEL 3330 VERSION 1.0 SOFTWARE.
P990066|S019|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2005|05/25/2005|||APPR|APPROVAL FOR CHANGES IN TWO SOFTWARE MODIFICATIONS THAT HAVE BEEN MADE TO THE ACQUISITION WORKSTATION (AWS) AND FOR AN ADDITIONAL SUPPLIER FOR THE CONDITIONER (CHILLER FOR THE IMAGE RECEPTOR).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM AND IS INDICATED AS FOLLOWS:  THE SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER.  THE SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED TO BE USED IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHIC SYSTEM.
P030032|S003|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|HYLAFORM, HYLAFORM PLUS, ND CAPTIQUE|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|04/20/2005|07/01/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P950022|S024|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST LEAD MODELS 7000, 7001, AND 7002|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2005|06/03/2005|||APPR|APPROVAL FOR ADDITION OF THE RIATA ST LEAD MODELS 7000, 7001, AND 7002 TO THE RIATA DEFIBRILLATION LEAD SYSTEM.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA ST MODELS 7000, 7001, AND 7002 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.
P040043|S002|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2005|05/20/2005|||OK30|CHANGE FROM A HAND ASSEMBLY PROCESS TO A SEMI-AUTOMATED PROCESS IN THE ASSEMBLY OF THE DELIVERY CATHETER.
P910023|S079|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2005|05/09/2005|||OK30|ALTERNATE PROCESS FOR REMOVING EPOXY FROM THE CONNECTOR BLOCK THREADED BORES OF THE ICD DEVICES.
P030054|S009|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|DUAL CHAMBER IMPLANTABLE CARDIOVERTER|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2005|05/09/2005|||OK30|ALTERNATE PROCESS FOR REMOVING EPOXY FROM THE CONNECTOR BLOCK THREADED BORES OF THE ICD DEVICES.
P980006|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/25/2005|05/27/2005|||APPR|APPROVAL FOR A MULTIFOCAL DESIGN OF THE BAUSCH & LOMB PUREVISION VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) AND PRESBYOPIA IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS OR LESS, THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00D TO -18.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00 TO -20.00 FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS WITH ADD POWERS RANGING FROM +0.75 TO +5.00D.
P790019|S019|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|ABBOTT HAVAB -M EIA|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2005|05/25/2005|||APPR|APPROVAL FOR CHANGE IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, OR OTHERWISE PROVIDE ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH, OR RELIABILITY OF THE ABBOTT HAVAB -M EIA ASSAY.
P980053|S009|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/06/2005|05/25/2005|||APPR|APPROVAL FOR INCLUSION OF THE 5-YEAR POST-MARKET STUDY INFORMATION IN THE DIRECTIONS FOR USE.
P900056|S084|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)||N|04/25/2005|05/25/2005|||APPR|APPROVAL FOR AN ADDITIONAL QUALITY CONTROL (QC) INSPECTION METHOD USING THE PASSAGE OF GUIDEWIRE THROUGH THE ROTALINK PLUS DEVICE LUMEN TO VERIFY THE DEVICE IS FREE FROM OBSTRUCTIONS.
P010062|S003|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR|NUU|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|04/18/2005|02/21/2006|||APPR|APPROVAL OF REVISIONS TO THE POST-APPROVAL REGRESSION ANALYSIS PROTOCOL.
P010014|S002|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2005|05/27/2005|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE TIBIAL BASEPLATE.
P860057|S028|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 6900,X|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2005|05/20/2005|||OK30|CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.
P990025|S009|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/2005|01/26/2006|||APPR|APPROVAL FOR ADDING REMOTE MAGNETIC NAVIGATION TECHNOLOGY TO THE PREVIOUSLY APPROVED CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING AND FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR (4) YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.  WHEN USED WITH THE CARGO? EP NAVIGATION SYSTEM, THE NAVISTAR RMT CATHETER PROVIDES LOCATION INFORMATION.
P870077|S019|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2005|05/20/2005|||OK30|CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.
P000007|S008|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500, 2500P|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2005|05/20/2005|||OK30|CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.
P010041|S008|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650,6650|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2005|05/20/2005|||OK30|CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.
P870056|S021|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPRSOTHESIS, MODEL 2625,6625|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2005|05/20/2005|||OK30|CHANGE IN THE SUPPLIER OF POLYETHYLENE TEREPHTHALATE (PET) POLYESTER YARN AND KNITTED POLYESTER FABRIC.
P970008|S028|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2005|02/06/2006|||APPR|APPROVAL FOR MODIFICATION OF THE CONTROL UNIT (TARGIS "COOL WAVE" CONTROL UNIT MODEL 5000A OR NEXT GENERATION CONTROL UNIT - NGCU), SOFTWARE, AND OPERATING MODES FOR BOTH THE TARGIS MICROWAVE DELIVERY SYSTEM (MDS) AND TARGIS COOLED THERMOCATH MDS.
P980049|S020|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/2005|04/28/2006|||APPR|APPROVAL FOR AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT COMBINES FEATURES OF THE ALTO 2 DR 624, ALTO 2 VR 625 ICDS, AND SYMPHONY 2550 PACEMAKER, INCLUDING REDUCED SIZE, MODIFIED SHOCK CIRCUITRY AND OTHER CHANGES.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD WITH HSO 2.76 SOFTWARE AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR TACHYARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO VENTRICULAR TACHYARRHYTHMIA, 2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT).NOTE:  THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE VT PATIENTS IS NOT FULLY KNOWN.  SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.
P900009|S020|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2005|05/19/2005|||OK30|ADDITION OF A NEW CONTRACT VENDOR FOR THE SUPPLY OF COMPONENTS/ MATERIALS USED IN THE MANUFACTURING PROCESS.
P980037|S013|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-ANGIOJET XMI-RX+CATHETER|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/02/2005|01/10/2007|||APPR|APPROVAL FOR ANGIOJET XMI-RX+ CATHETER.
P910066|S021|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|SPINALOGIC 1000 BONE GROWTH STIMULATOR|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/01/2005|07/19/2005|||APPR|APPROVAL FOR THE DESCRIBED COIL MODIFICATIONS INCLUDING GEOMETRIC CHANGES, TURN SCHEDULE CHANGES, AND MANUFACTURING CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC 1000 BONE GROWTH STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
P960028|S013|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|Normal 180 Day Track||N|06/28/2005|12/21/2005|||APPR|APPROVAL FOR MODIFICATION OF THE INDICATION STATEMENT WITH STANDARDIZED LANGUAGE FOR THE MODELS OF THE ARRAY FAMILY OF MULTIFOCAL INTRAOCULAR LENSES (MODELS SA40N, SA40N2, SA40E, AA40E, AA50 AND NXG1).  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARRAY AND ARE INDICATED FOR: THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT READING ADD AND INCREASED SPECTACLE, INDEPENDENCE.
P000032|S009|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2005|05/26/2005|||OK30|ADDITION OF A NEW TYPE OF FILTER TO THE CRYOSTAT, CHANGE TO ENHANCE THE CORROSION RESISTANCE OF THE CRYOSTAT TUBING, CHANGE IN THE CRYOSTAT CLEANING METHOD.
P020002|S001|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP IMAGING SYSTEM|MNM|PA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|05/03/2005|06/08/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORPORATION, MARLBOROUGH, MASSACHUSETTS.
P850079|S042|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|COOPERVISION, INC. HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHAFILCON B) SOFT (HYDROPHILIC)...|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2005|06/14/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOPERVISION, INC., SCOTTSVILLE, NEW YORK.
P960058|S042|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2005|09/21/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE FOR RECEIVING, RECEIVING INSPECTION, STAGING, PACKAGING FINISHED GOODS, AND SHIPPING LOCATED AT ADVANCED BIONICS, SYLMAR, CALIFORNIA.
P030017|S007|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINALCORD STIMULATION|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2005|09/16/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE FOR RECEIVING, RECEIVING INSPECTION, STAGING, PACKAGING, FINISHED GOODS, AND SHIPPING LOCATED AT ADVANCED BIONICS, SYLMAR, CALIFORNIA.
P990066|S020|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2005|07/01/2005|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE SENOGRAPHE DS AND (2000D) FFDM ACQUITION WORKSTATION (AWS) AND REVIEW WORKSTATION TO ALLOW USERS TO SELECT THE PREMIUM VIEW (PV) ALGORITHM AS PRIMARY IMAGE PROCESSING.
P000037|S005|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2005|06/03/2005|||OK30|CHANGE IN THE SEWING RING CLOTH ENDOTOXIN TESTING TO ALLOW FOR COMBINATION OF SAMPLES.
P030030|S002|C.R. Bard, Inc.|13183 HARLAND DRIVE||COVINGTON|GA|30014|6421|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|BARD TEGRESS URETHRAL IMPLANT|LNM|GU|Normal 180 Day Track No User Fee||N|05/04/2005|05/27/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE AT BARD SHANNON LTD., LAS PIEDRAS, PUERTO RICO, 00771.
P040043|S003|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2005|05/27/2005|||OK30|EXPANSION OF THE CONTROLLED MANUFACTURING ENVIRONMENT AT WOODY SPRINGS.
P890003|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|EDTRONIC 2030A BATTERYCHECK MONITOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/05/2005|06/08/2005|||APPR|APPROVAL FOR THE MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR MODEL 7278, MAXIMO VR MODEL 7232, MARQUIS DR MODEL 7274, AND MARQUIS VR MODEL 7230.
P980016|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR...|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/05/2005|06/08/2005|||APPR|APPROVAL FOR THE MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR MODEL 7278, MAXIMO VR MODEL 7232, MARQUIS DR MODEL 7274, AND MARQUIS VR MODEL 7230.
P010031|S023|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR...|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/05/2005|06/08/2005|||APPR|APPROVAL FOR THE MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR MODEL 7278, MAXIMO VR MODEL 7232, MARQUIS DR MODEL 7274, AND MARQUIS VR MODEL 7230.
P910007|S013|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE|ABBOTT IMX TOTAL PSA|JJE|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|05/05/2005|06/13/2005|||APPR|APPROVAL OF THE NEW METHOD COMPARISONS BETWEEN THE IMX TOTAL PSA ASSAY AND THE IMX PSA ASSAY.  THE COMPARISONS INCLUDE REGRESSION ANALYSES (PASSING-BABLOK AND LEAST SQUARES LINEAR REGRESSION) AND BIAS ANALYSIS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME IMX TOTAL PSA ASSAY AND IS INDICATED AS FOLLOWS:  THE IMX TOTAL PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPSIN) IN HUMAN SERUM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER.  PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.  2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.
P020026|S013|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE WIRE DELIVERY|NIQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/05/2005|06/06/2005|||APPR|APPROVAL FOR LABELING CHANGES TO BETTER INFORM PATIENTS AND HEALTH CARE PROVIDERS ABOUT THE RISKS OF EARLY DISCONTINUATION OF ANTIPLATELET THERAPY AND THAT RESPONDS TO A LETTER SENT TO CORDIS BY FDA DATED APRIL 21, 2005.
P020004|S011|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/2005|09/28/2005|||APPR|APPROVAL FOR THE ADDITION OF A SHORTER (12 CM) TRUNK/IPSILATERAL COMPONENT TO THE GORE EXCLUDER? BIFURCATED ENDOPROSTHESIS PRODUCT LINE.
P890003|S086|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|CARELINK PROGRAMMER (MODEL 2090)/ANALYZER (MODEL 2290)|DXY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/2005|09/28/2005|||APPR|APPROVAL FOR "SOFTWARE ENHANCEMENTS" TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE CARELINK PROGRAMMER AND THE MODEL 8190 ANALYZER SOFTWARE FOR THE MODEL 2290 ANALYZER.
P030002|S003|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)|NAA|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2005|06/06/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT LIFE SCIENCES OUTSOURCING (LSO), BREA, CALIFORNIA.
P000014|S012|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2005|05/25/2005|||OK30|CHANGE IN SCALE OF REAGENT MANUFACTURING.
P970008|S029|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2005|03/23/2006|||APPR|APPROVAL FOR THE ADDITION OF A RADIO FREQUENCY IDENTIFICATION (RFID) SYSTEM TO PREVENT REUSE OF THE DISPOSABLE DEVICE COMPONENTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE DELIVERY OF MICROWAVE ENERGY TO THE PROSTATE FOR THE TREATMENT OF BPH IN A SINGLE SESSION.  IT IS INDICATED FOR PATIENTS WITH PROSTATIC LENGTHS OF 30 TO 50 MM.
P030025|S019|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2005|06/07/2005|||OK30|TIGHTENING OF ACCEPTANCE CRITERIA FOR AN IN-PROCESS INSPECTION TEST FOR THE MATTE FINISH LENGTH.
P020009|S022|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2005|06/07/2005|||OK30|TIGHTENING OF ACCEPTANCE CRITERIA FOR AN IN-PROCESS INSPECTION TEST FOR THE MATTE FINISH LENGTH.
P040016|S001|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2005|06/07/2005|||OK30|TIGHTENING OF ACCEPTANCE CRITERIA FOR AN IN-PROCESS INSPECTION TEST FOR THE MATTE FINISH LENGTH.
P030011|S001|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T)|LOZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|05/10/2005|10/26/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P990020|S018|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2005|06/17/2005|||OK30|CHANGE IN THE MANUFACTURING PROCESS IMPLEMENTING ADDITIONAL INSPECTION AND PROCESS CLARIFICATIONS TO ENSURE PROPER FUNCTION OF THE XCELERANT DELIVERY SYSTEM USED TO DELIVER THE ANEURX STENT GRAFT.
P020004|S012|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2005|06/07/2005|||OK30|CHANGE TO THE JOINING METHOD AT A JUNCTION ON THE TUBING.
P960011|S010|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY|LZP|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/11/2005|09/15/2005|||APPR|APPROVAL TO INCLUDE IOLTECH, CIDRA, PUERTO RICO AS A DISTRIBUTOR FOR BIOLON IN THE UNITED STATES.
P970004|S032|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/2005|05/27/2005|||APPR|APPROVAL FOR THE ADDITION OF A PRECAUTION STATEMENT TO THE TECHNICAL MANUAL OF THE MODEL 8840 N'VISION PROGRAMMER REGARDING THE PRESENCE OF FLAMMABLE ANESTHETIC AGENTS.
P010013|S014|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/2005|07/22/2005|||APPR|APPROVAL FOR A MODIFICATION TO THE DEVICE PERFORMANCE PROTOCOL USED TO ESTABLISH THE SHELF LIFE OF THE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM.  THE PROTOCOL USED TO ASSESS PACKAGE INTEGRITY, I.E., PPQ-012, PREVIOUSLY APPROVED IS UNCHANGED.)
P960040|S054|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2896 VERSION 2.0|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2005|06/03/2005|||APPR|APPROVAL FOR THE CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2896 VERSION 2.0.
P980049|S021|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ISOLINE 2CR DEFIBRILLATION LEADS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/2005|01/15/2008|||APPR|APPROVAL FOR: 1) MODIFICATIONS TO THE SWIFT 1CT SERIES ICD LEAD TO CREATE A DUAL-COIL, INTEGRATED BIPOLAR, ACTIVE-FIXATION ICD LEAD.  THE NEW LEAD WILL BE MARKETED UNDER THE NAME ISOLINE 2CR AND IS INDICATED FOR USE WITH ELA MEDICAL IMPLANTABLE DEFIBRILLATORS; 2) MANUFACTURING SITE AT SORIN BIOMEDICA CRM SRL, SALUGGIA, ITALY AND TWO STERILIZATION SITES AT BIOSTER SPA, BERGAMO, ITALY.
P900060|S032|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS & CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTH|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2005|03/30/2006|||APPR|
P990001|S019|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|VITATRON T-SERIES SOFTWARE MODEL VSF07/08, VSE03/04|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2005|09/21/2005|||APPR|APPROVAL FOR CHANGES TO THE CALIBRATOR AND CONTROL RECOVERY RANGES.
P920047|S027|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS|LPB|CV|Real-Time Process||N|05/19/2005|06/17/2005|||APPR|APPROVAL FOR THE BLAZER II AND BLAZER II XP CATHETERS WITH MODIFIED MECHANICAL PERFORMANCE SPECIFICATIONS.
P020025|S011|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II/BLAZER II XP CARDIAC ABLATION CATHETERS|OAD|CV|Real-Time Process||N|05/19/2005|06/17/2005|||APPR|APPROVAL FOR THE BLAZER II AND BLAZER II XP CATHETERS WITH MODIFIED MECHANICAL PERFORMANCE SPECIFICATIONS.
P020018|S006|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2005|06/14/2005|||OK30|ALTERNATIVE SUPPLIER OF WOVEN POLYESTER FABRIC.
P030010|S002|SIEMENS MEDICAL SOLUTION|51 VALLEY STREAM PKWY.||MALVERN|PA|19355||Full field digital,system,x-ray,mammographic|SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2005|06/20/2005|||APPR|APPROVAL FOR LABELING CHANGES TO THE OPERATORS MANUAL WHICH ADD OR STRENGTHEN A CONTRAINDICATION, WARNING, PRECAUTION, OR INFORMATION ABOUT AN ADVERSE REACTION AND ADD OR STRENGTHEN AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
P040043|S004|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|04/21/2005|05/27/2005|||OK30|EXPANSION OF THE CONTROLLED MANUFACTURING ENVIRONMENT AT ELK HILL.
P910016|S014|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|UNICOMPARTMENTAL DEVICE CONFIGURATION OF THE LCS TOTAL KNEE SYSTEM|MBD|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|05/23/2005|09/26/2005|||APPR|APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDY.
P040043|S005|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2005|06/14/2005|||OK30|CHANGE FROM A MANUAL CUTTING PROCESS TO AN AUTOMATED CUTTING PROCESS FOR CUFF COMPONENTS.
P020004|S013|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2005|06/14/2005|||OK30|CHANGE FORM A MANUAL CUTTING PROCESS TO AN AUTOMATED CUTTING PROCESS FOR CUFF COMPONENTS.
P950032|S041|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2005|06/20/2005|||OK30|CHANGES TO FORMULATIONS USED IN THE APLIGRAF MANUFACTURING PROCESS.
P960040|S055|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|LWP|CV|30-Day Notice||N|05/26/2005|06/14/2005|||OK30|USE OF AN ALTERNATE EPOXY IN THE MANUFACTURE OF POWER MODULES FOR THE VITALITY FAMILY OF ICDS AND THE CONTAK RENEWAL FAMILY OF CRT-D DEVICES.
P010012|S047|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2005|06/14/2005|||OK30|USE OF AN ALTERNATE EPOXY IN THE MANUFACTURE OF POWER MODULES FOR THE VITALITY FAMILY OF ICDS AND THE CONTAK RENEWAL FAMILY OF CRT-D DEVICES.
P900060|S033|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2005|07/21/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT THE SORIN BIOMEDICA CARDIO, S.R.L. FACILITY IN SALUGGIA, ITALY TO MANUFACTURE PYROLYTIC CARBON COMPONENTS FOR THE CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES.
P970043|S020|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/27/2005|05/01/2006|06M-0323|08/17/2006|APPR|APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM.  THESE DEVICES USE A 6.5 MM OPTICAL ZONE AND A 9.0 TREATMENT ZONE AND ARE INDICATED FOR WAVE-FRONT GUIDED CUSTOMCORNEA LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AND HYPEROPIC ASTIGMATISM OF +0.75 D TO LESS THAT +5.00 D OF SPHERE WITH UP TO -3.00 D OF CYLINDER (WHICH HAS A MAGNITUDE LESS THAN OR EQUAL TO THE SPHERE IN MINUS CYLINDER CONVENTION) AND UP TO +5.00 CYCLOPLEGIC SPHERICAL EQUIVALENT AT THE SPECTACLE PLANE; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE IN SPHERE AND CYLINDER OF LESS THAN OR EQUAL TO 0.50 D.
P830060|S058|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GUIDANT PULSE GENERATORS|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/27/2005|06/20/2005|||APPR|APPROVAL FOR ADDITIONAL INSTRUCTION FOR USE FOR FREEING STUCK SETSCREWS USING THE BI-DIRECTIONAL TORQUE WRENCH.
P030017|S008|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/2005|08/18/2005|||APPR|APPROVAL FOR ARTISAN 2 X 8 PADDLE LEAD, MODEL SC-8116-XX.
P960058|S043|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2005|12/23/2005|||APPR|APPROVAL FOR PROCESS CONTROL IMPROVEMENTS TO THE HIRES90K COIL-CASE/ELECTRODE SUBASSEMBLY FINAL MOLDING PROCESS.  THE PROPOSED CHANGES INCLUDE AN EXTERNAL THERMOCOUPLE TO PROVIDE CLOSED-LOOP CONTROL OF THE MOLD TEMPERATURE, THEREBY PROVIDING BETTER CONTROL OF THE CURING TEMPERATURE OF THE SILICONE, AND BY CONFIGURING THE MOLD TOOL WITH SPRING WASHER (BELLEVILLE WASHERS) TO ALLOW FOR SMOOTHER MOVEMENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR INDIVIDUALS AGED 12 MONTHS AND OLDER WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS TO RESTORE A LEVEL OF AUDITORY SENSATION VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.
P950022|S025|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|ST.JUDE MEDICAL RIATA/ RIATA I DEFIBRILLATION LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/2005|11/04/2005|||APPR|APPROVAL FOR THE ADDITION OF SIX LEAD MODELS WITH ELAST-EON 2A LEAD BODY INSULATION MATERIAL TO THE ST. JUDE MEDICAL RIATA/RIATA I DEFIBRILLATION LEAD SYSTEM.
P030006|S006|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/31/2005|07/22/2005|||APPR|APPROVAL FOR USE OF A NEW COMPUTER MOTHERBOARD TO REPLACE AN OBSOLETE MOTHERBOARD CURRENTLY USED IN THE PROLIEVE THERMODILATATION SYSTEM.
P990066|S021|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track||N|06/01/2005|04/11/2006|||APPR|APPROVAL FOR SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM WITH INCREASED DETECTOR AREA TO ACCOMMODATE A LARGER RANGE OF BREAST SIZES FOR THE PURPOSE OF SCREENING AND DIAGNOSIS.
P030026|S006|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2005|06/22/2005|||OK30|ADDITION OF SERUM TO THE LIST OF RAW COMPONENTS.
P880091|S018|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2005|06/28/2005|||OK30|ALTERNATE SUPPLIER FOR THE UV CHROMOPHORE.
P990044|S007|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-CORE-IGMK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2005|06/22/2005|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P990043|S009|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2005|06/22/2005|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P990041|S008|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2005|06/22/2005|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P990038|S010|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-MAK-2PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2005|06/22/2005|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P890019|S011|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|DIASORIN ETI-AB-HAVK PLUS|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2005|06/22/2005|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P890014|S007|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|DIASORIN ETI-HA-IGMK PLUS|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2005|06/22/2005|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P890003|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|MEDTRONIC MODEL 2490G CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2005|07/18/2005|||APPR|APPROVAL FOR THE CARELINK MONITOR MODEL 2490G FOR USE WITH ADDITIONAL PULSE GENERATOR MODELS, SPECIFICALLY THE INSYNC SENTRY MODEL 7299, INSYNC MAXIMO MODEL 7304, AND THE V-V TIMING FEATURE FOR BOTH THE INSYNC SENTRY MODEL 7297 AND THE INSYNC MAXIMO MODEL 7303.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P010031|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC INSYNC MAXIMO MODEL 7304 AND MODEL 7303|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2005|07/18/2005|||APPR|APPROVAL FOR THE CARELINK MONITOR MODEL 2490G FOR USE WITH ADDITIONAL PULSE GENERATOR MODELS, SPECIFICALLY THE INSYNC SENTRY MODEL 7299, INSYNC MAXIMO MODEL 7304, AND THE V-V TIMING FEATURE FOR BOTH THE INSYNC SENTRY MODEL 7297 AND THE INSYNC MAXIMO MODEL 7303.  THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
P000029|S013|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2005|12/12/2005|||APPR|APPROVAL FOR PERFORMING THE PROTEIN TESTING IN-HOUSE AT THE Q-MED QUALITY CONTROL LABORATORY AND TO CHANGE THE TEST METHOD SO AS TO ALLOW FOR THE DETECTION OF LOWER AMOUNTS OF PROTEIN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEFLUX AND IS INDICATED FOR THE TREATMENT OF VESICOURETERAL REFLUX IN CHILDREN.
P020023|S012|Q-Med AB|SEMINARIEGATAN 21|SE-752 28|UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2005|10/21/2005|||APPR|APPROVAL FOR PERFORMING THE PROTEIN TESTING IN-HOUSE AT THE Q-MED QUALITY CONTROL LABORATORY AND TO CHANGE THE TEST METHOD SO AS TO ALLOW FOR THE DETECTION OF LOWER AMOUNTS OF PROTEIN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RESTYLANE AND IS INDICATED AS AN INJECTABLE GEL FOR AESTHETIC USE.
P020045|S008|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2005|06/24/2005|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS OF THE INCOMING INSPECTION OF THE STOP BUTTON SUBASSEMBLY AND THE FINAL INSPECTION OF THE FINISHED PRODUCT.
P990020|S019|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2005|06/24/2005|||APPR|APPROVAL TO ADD AN ADDITIONAL TENSILE TEST OF THE DELIVERY SYSTEM DURING THE DEVICE MANUFACTURING PROCESS.
P910065|S006|TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|AIA-PACK PA PSA, ST AIA-PACK PA PSA|LTJ|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/2005|11/30/2005|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS OF THE MONOCLONAL ANTIBODIES USED IN THE PRODUCTION OF THE ASSAYS AND CHANGE IN THE MANUFACTURING FACILITY USED FOR THE ABOVE MANUFACTURING PROCESS FROM NISSEIKEN CO., LTD., TOKYO, JAPAN TO TOSOH AIA, INC. IN TOYAMA, JAPAN.
P030054|S010|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC AND ATLAS+ HF CRT-D SYSTEMS|NIK|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/06/2005|11/18/2005|05M-0492|12/19/2005|APPR|APPROVAL FOR THE MODIFICATION OF THE INDICATIONS FOR THE EPIC AND ATLAS+ HF CRT-D SYSTEMS, SPECIFICALLY THE MAINTENANCE OF SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE. THE ST. JUDE MEDICAL THE EPIC AND ATLAS+ HF CRT-D SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.   IN PATIENTS INDICATED FOR AN ICD, THE EPIC AND ATLAS+ HF CRT-D SYSTEMS ARE ALSO INTENDED:1) TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P000033|S002|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|INTRACOIL SELF-EXPANDING PERIPHERAL STENT|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2005|07/07/2005|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO THE LABEL PRINTING AND LABEL VERIFICATION PROCESS.
P030025|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)|NIQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/07/2005|06/29/2005|||APPR|APPROVAL FOR LABELING (DIRECTIONS FOR USE (DFU), PATIENT GUIDE AND PATIENT CARD) CHANGES.
P020045|S009|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2005|06/27/2005|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS AND MANUFACTURING PROCESS THAT ADD A NEW SPECIFICATION FOR THE STOP BUTTON AND THE ADDITION OF A NEW VALIDATION TEST FOR THE STOP BUTTON.
P000032|S011|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2005|06/30/2005|||OK30|USE OF MECHANICAL CRIMPING, INSTEAD OF SOLDERING, TO FORM A JOINT THAT CONNECTS A CAPILLARY TUBE TO A COMPRESSOR CIRCUIT OF THE CRYOSTAT SUBASSEMBLY.
P000020|S010|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|SCORPION/SCORPION M ABLATION CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2005|02/16/2006|||APPR|APPROVAL FOR THE ADDITION OF A SECOND ARTICULATION TO THE STINGER S/STINGER SM LINE OF RF ABLATION CATHETERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCORPION/SCORPION M, AND IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS, AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.  IN ADDITION, APPROVAL FOR A CHANGE IN THE INDICATIONS FOR USE OF THE TEMPLINK/ TEMPLINK M CONNECTION CABLES TO INCLUDE THE SCORPION/SCORPION M CATHETERS IN THE LIST OF CATHETERS WITH WHICH IT CAN BE USED.
P930038|S044|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/13/2005|09/02/2005|||APPR|APPROVAL FOR INSTRUCTIONS FOR USE/LABELING CHANGES.
P960040|S056|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, PRIZM 2, PRIZM HE, VITALITY, VITALITY AVT, VITALITY DS, VITALITY 2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2005|07/07/2005|||OK30|REMOVAL OF A MANUAL AUDIT OF AN INCOMING INSPECTION PROCESS FOR IC WAFERS
P010012|S048|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTRK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2005|07/07/2005|||OK30|REMOVAL OF A MANUAL AUDIT OF AN INCOMING INSPECTION PROCESS FOR IC WAFERS.
P910073|S051|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE TRANSVENOUS ENDOCARDIAL DEFIBRILLATION LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2005|07/08/2005|||OK30|USE OF AN ALTERNATIVE SILICONE ADHESIVE IN THE MANUFACTURE OF THE RELIANCE FAMILY OF LEADS.
P900030|S009|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN BARD COLLAGEN IMPLANT|LNM|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|06/13/2005|09/21/2006|||APPR|APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDE INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT B.
P040024|S001|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTION GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2005|07/12/2005|||OK30|CHANGES TO PROCESSING METHODS USED IN THE MANUFACTURING OF RESTYLANE INJECTABLE GEL.
P020045|S010|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/16/2005|09/02/2005|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE STOP BUTTON ON THE CRYOCONSOLE FROM THE CURRENT SIZE OF 19 MM TO THE PROPOSED 16 MM SIZE STOP BUTTON.
P000009|S016|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/16/2005|08/11/2005|||APPR|APPROVAL TO IMPLEMENT INTRACARDIAC ELECTROGRAM (IEGM) SNAPSHOTS OF TACHYCARDIA EVENTS INTO HOME MONITORING TRANSMISSIONS.  IN ORDER TO ACCOMPLISH THIS, YOU HAVE REQUESTED THE APPROVAL OF THE LUMOS FAMILY OF ICDS PROGRAMMER SOFTWARE UPGRADES, AND AN UPGRADE TO THE CURRENTLY MARKETED HOME MONITORING SERVICE CENTER.
P790002|S023|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|EBI BONE HEALING SYSTEM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2005|09/26/2005|||APPR|APPROVAL FOR THREE NEW COILS: THE FLX 5, THE XL COILETTE AND THE MINI COILETTE AND A MODIFIED VERSION OF THE BONE HEALING SYSTEM MODEL 2001 CONTROLLER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI BONE HEALING SYSTEM AND IS INDICATED FOR THE TREATMENT OF FRACTURE NON-UNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDOARTHROSES IN THE APPENDICULAR SYSTEM.
P000037|S006|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2005|07/11/2005|||OK30|CHANGE IN THE CLEANING METHODS USED TO REMOVE MANUFACTURING MATERIALS.
P880086|S104|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|PULSE GENERATOR|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2005|07/08/2005|||OK30|REMOVAL OF AN AUTOMATIC WASHING MACHINE STEP IN THE CURRENT WASHING PROCESS OF PACEMAKERS.
P980018|S004|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEP TEST|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2005|07/13/2005|||OK30|CHANGE IN THE SUPPLIER OF THE REAGENT FOR IMMUNIZATION OF RABBITS AND SUBSEQUENT CHANGES IN MANUFACTURING PROCESS AND QUALITY CONTROL PROCEDURES.
P000040|S005|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2005|07/12/2005|||APPR|APPROVAL FOR MANUFACTURING PROCESS AND QUALITY CONTROL CHANGES TO THE ADAPTERS USED TO CONNECT A HYSTEROSCOPE TO THE HTA SYSTEM PROCEDURE SHEATH.
P980024|S002|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|VYSIS PATH VYSION HER-2 DNA PROBE KIT|MVD|PA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|06/20/2005|05/10/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT DES PLAINES, DES PLAINES, ILLINOIS.
P030052|S001|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|06/20/2005|05/10/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT DES PLAINES, DES PLAINES, ILLINOIS.
P960040|S058|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY ICD MODELS T125, T127, T135 AND VITALITY AVT ICD MODEL A155|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2005|07/21/2005|||OK30|REMOVAL OF THE TIME-LIMITED ZOOM PROGRAMMER TEST FROM THE MANUFACTURING PROCESS.
P960040|S059|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM ICS MODELS 1850, 1851, 18521853|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2005|07/21/2005|||OK30|CHANGE IN THE SET SCREW PRELOAD VERIFICATION PROCESS.
P010012|S049|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD CRT-D MODELS H115, H119 AND CONTAK RENEWAL CRT-D MODELS H120, H125|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2005|07/21/2005|||OK30|CHANGE IN THE SET SCREW PRELOAD VERIFICATION PROCESS.
P030005|S009|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VITALITY AVT ICDS MODELS A135, A155|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2005|07/21/2005|||OK30|CHANGE IN THE SET SCREW PRELOAD VERIFICATION PROCESS.
P860004|S072|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2005|07/19/2005|||OK30|CHANGE IN QUALITY CONTROL TESTS USED ON COMPONENTS IN THE SYNCHROMED II PUMP.
P960040|S061|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, PRIZM 2, VITALITY, VITALITY 2 & VITALITY AVT|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2005|07/21/2005|||OK30|REMOVAL OF A SECOND CYCLE OF ELECTRICAL TESTING FOR CAPACITORS.
P010012|S050|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL & CONTAK RENEWAL 3 RF|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2005|07/21/2005|||OK30|REMOVAL OF A SECOND CYCLE OF ELECTRICAL TESTING FOR CAPACITORS.
P940031|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR,DISCOVERY,AND MERIDIAN PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2005|07/21/2005|||OK30|CHANGE TO LEAK TEST SOFTWARE OPERATOR LOGIN FOR BRADY PULSE GENERATORS.
P040024|S002|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTION GEL|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2005|01/19/2006|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY IN UPPSALA, SWEDEN.
N12159|S020|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL /  SURGICEL NU-KNIT / SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2005|07/22/2005|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NEW JERSEY.
P010025|S007|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/2005|10/31/2005|||APPR|APPROVAL FOR A CHANGE IN THE STRUCTURE OF THE A-SELENIA TFT IMAGE RECEPTOR TO REDUCE IMAGE GHOSTING.
P000021|S008|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION TPSA FLEX REAGENT CARTRIDGE|LTJ|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2005|07/11/2005|||OK30|CHANGE TO PREVENT LOSS OF REAGENT DUE TO MICROBIAL CONTAMINATION.
P960040|S062|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2005|07/22/2005|||OK30|ALTERNATE SUPPLIER OF THE TRIM RESISTOR ARRAYS USED IN THE HYBRID BUILDS OF THE PULSAR MAX, VENTAK AND CONTAK CD FAMILIES OF DEVICES.
P010012|S051|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2005|07/22/2005|||OK30|ALTERNATE SUPPLIER OF THE TRIM RESISTOR ARRAYS USED IN THE HYBRID BUILDS OF THE PULSAR MAX, VENTAK AND CONTAK CD FAMILIES OF DEVICES.
P860004|S073|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2005|07/19/2005|||OK30|CHANGE IN QUALITY CONTROL TESTS USED ON COMPONENTS IN THE SYNCHROMED II PUMP.
P880047|S009|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED (TC7) ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2005|07/22/2005|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NEW JERSEY.
P830079|S016|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT COLLAGEN HEMOSTAT|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2005|07/22/2005|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NEW JERSEY.
P990020|S020|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/2005|03/17/2006|||APPR|APPROVAL FOR  ADDITIONAL ILIAC SIZES (INCLUDING 18MM AND 20MM DIAMETERS; FLARED ILIAC AND ILIAC CUFFS IN 16 MM X 20MM, 18MM X 22MM, AND 18MM X 24MM); A LONGER AORTIC BODY OF THE BIFURCATED COMPONENT BY 1 CM; PRE-SHAPED (CONTOURED) STENT RINGS; AND PLATINUM-IRIDIUM RADIOPAQUE MARKETS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM AND IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING: 1) ADEQUATE ILIAC/FEMORAL ACCESS; 2) INFRARENAL, NON-ANEURYSMAL, NECK LENGTH OF GREATER THAN 1 CM AT THE PROXIMAL AND DISTAL ENDS OF THE ANEURYSM AND AN INNER VESSEL DIAMETER APPROXIMATELY 10-20% SMALLER THAN THE LABELED DEVICE DIAMETER; 3) MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR; 4) ONE OF THE FOLLOWING: ANEURYSM DIAMETER > 5 CM; ANEURYSM DIAMETER OF 4-5 CM WHICH HAS ALSO INCREASED IN SIZE BY 0.5 CM IN THE LAST 6 MONTHS; OR ANEURYSM WHICH IS TWICE THE DIAMETER OF THE NORMAL INFRARENAL AORTA.
P910077|S052|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/08/2005|||OK30|CHANGES IN PROCEDURES FOR CYTOTOXICITY AND PYROGENICITY TESTING FOR INSPECTIONS OF INCOMING COMPONENTS.
P940031|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY, MERIDIAN|LWP|CV|30-Day Notice||N|06/27/2005|07/08/2005|||OK30|CHANGES IN PROCEDURES FOR CYTOTOXICITY AND PYROGENICITY TESTING FOR INSPECTIONS OF INCOMING COMPONENTS.
P960040|S063|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, VENTAK AV, VENTAK VR, VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/08/2005|||OK30|CHANGES IN PROCEDURES FOR CYTOTOXICITY AND PYROGENICITY TESTING FOR INSPECTIONS OF INCOMING COMPONENTS.
P010012|S052|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD, CONTAK RENEWAL, EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/08/2005|||OK30|CHANGES IN PROCEDURES FOR CYTOTOXICITY AND PYROGENICITY TESTING FOR INSPECTIONS OF INCOMING COMPONENTS.
P030005|S010|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/08/2005|||OK30|CHANGES IN PROCEDURES FOR CYTOTOXICITY AND PYROGENICITY TESTING FOR INSPECTIONS OF INCOMING COMPONENTS.
P030026|S007|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/18/2005|||OK30|CHANGE IN THE ACCEPTANCE CRITERIA FOR AN INITIAL MANUFACTURING STEP.
P940031|S037|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN/DISCOVERY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/27/2005|||OK30|CHANGES TO THE SOFTWARE USED IN THE AUTOMATED SETSCREW PRELOAD VERIFICATION PROCESS.
P960040|S064|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY AVT, VITALITY DS, VITALITY EL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/27/2005|||OK30|CHANGES TO THE SOFTWARE USED IN THE AUTOMATED SETSCREW PRELOAD VERIFICATION PROCESS.
P010012|S053|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD 2, CONTAK RENEWAL 3 DS, CONTAK RENEWAL 3 HE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/27/2005|||OK30|CHANGES TO THE SOFTWARE USED IN THE AUTOMATED SETSCREW PRELOAD VERIFICATION PROCESS.
P940031|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2005|07/11/2005|||OK30|CHANGE THE DISTANCE BETWEEN THE ACCELEROMETER'S BEAM AND LID.
P960058|S045|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/2005|07/25/2005|||APPR|APPROVAL FOR AN UPDATED AURIA POWERPAK ASSEMBLY CONFIGURATION.
P960058|S046|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/27/2005|07/14/2005|||APPR|APPROVAL FOR A NEW AURIA EARHOOK, THE ICONNECT, TO PROVIDE AN EAR-LEVEL, CABLE-FREE INTERFACE FOR THIRD-PARTY MINIATURE FM RECEIVERS.
P990075|S016|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS|FWM|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/27/2005|07/27/2005|||APPR|APPROVAL FOR 1) NEW STYLE 2000 MODERATE PLUS PROFILE, WHICH IS CONSIDERED A MODIFICATION TO THE EXISTING PRODUCT INE, WITH SIZES 175CC-800CC; 2) ADDITIONAL SIZES OF 400CC, 450CC, 500CC, 600CC, 650CC AND 800CC FOR STYLE 1600; AND 3) ADDITIONAL SIZES OF 350CC, 400CC, 700CC, 770CC, AND 800CC FOR STYLE 3000.  THERE ARE NO CHANGES TO THE INDICATIONS FOR USE.
P880081|S031|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2005|08/04/2005|||OK30|CHANGE IN THE OUTER IOL BOX.
P960028|S014|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2005|08/04/2005|||OK30|CHANGE IN THE OUTER IOL BOX.
P010021|S006|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|135 Review Track For 30-Day Notice||N|06/27/2005|08/11/2005|||APPR|APPROVAL FOR EXTENSION OF SHELF-LIFE AND BIOBURDEN FOR A MANUFACTURING COMPONENT.
P910023|S080|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|implantable pacemaker Pulse-generator|ST.JUDE MEDICAL ICDS/CRT-D|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2005|12/16/2005|||APPR|APPROVAL FOR THE ELIMINATION OF AN EXTRA LAYER OF PARYLENE COATING THAT IS APPLIED OVER THE HIGH VOLTAGE CAPACITOR PRIOR TO ITS INSTALLATION INTO THE DEVICE ASSEMBLY DURING THE ICD/CRT-D MANUFACTURING.
P030054|S011|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST.JUDE MEDICAL ICDS/CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2005|12/16/2005|||APPR|APPROVAL FOR THE ELIMINATION OF AN EXTRA LAYER OF PARYLENE COATING THAT IS APPLIED OVER THE HIGH VOLTAGE CAPACITOR PRIOR TO ITS INSTALLATION INTO THE DEVICE ASSEMBLY DURING THE ICD/CRT-D MANUFACTURING.
P000025|S019|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/05/2005|07/25/2005|||APPR|APPROVAL FOR THE COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS TO UPDATE NON-ESSENTIAL LABELING AND A MANUAL FOR TROUBLESHOOTING FM SYSTEMS WHICH MAY BE USED ITH THE TEMPO+.
P020027|S004|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2005|07/13/2005|||OK30|CHANGE TO PREVENT LOSS OF REAGENT DUE TO MICROBIAL CONTAMINATION.
P850020|S020|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA PROTEIN A IMMUNOADSORPTION COLUMN|LKN|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2005|08/17/2005|||APPR|APPROVAL FOR ETHYLENE OXIDE (EO) STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., WAUKEGAN, ILLINOIS.
P980035|S043|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC ADAPTA,VERSA,&SENSIA IMPLANTABLE PULSE GENERATOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2005|07/17/2006|||APPR|APPROVAL FOR ADAPTA, VERSA AND SENSIA FAMILIES OF IMPLANTABLE PULSE GENERATORS WITH SOFTWARE SW003 VERSION 1.3.
P950029|S024|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2005|09/02/2005|||APPR|APPROVAL FOR THE FOLLOWING SOFTWARE UPDATES: 1) AAISAFER RAM PATCH 2.3 FOR SYMPHONY DR 2550 DEVICES WITH ROM MASK T3, 2) ROM MASK T4 FOR SYMPHONY DR 2550, SYMPHONY SR 2250, ELA RHAPSODY+ DR 2530, ELA RHAPSODY DR 2510, AND ELA RHAPSODY SR 2210, 3) ELAVIEW 1.30 UG2 APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER.
P960006|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FLEXTEND FAMILY OF PACING LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2005|08/04/2005|||OK30|ADDITION OF PRIMER TO THE INNER SURFACE OF THE ELECTRODE RING OF THE FLEXTEND LEADS TO INCREASE ADHESION OF THE ELECTRODE RING TO THE MOLDED NECK.
P010012|S054|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), MODELS H135, H170, H175, H177, AND H179|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2005|08/04/2005|||OK30|CHANGE IN TEST SOFTWARE FOR THE CONTAK RENEWAL CRT-DDEVICES PER ROUTINE PROCEDURES.
P030002|S004|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS SE, MODEL AT-45 SE|NAA|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/05/2005|09/08/2005|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PHYSICIAN'S LABELING: CHANGE IN THE MODEL NUMBER AND TRADE NAME; CHANGE IN DIRECTIONS FOR USE TO FACILITATE PROPER INSERTION AND ORIENTATION OF THE LENS; AND, CHANGE IN THE EXISTING RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS SE (MODEL AT-45 SE) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO THE REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA.  THE CRYSTALENS SE (MODEL AT-45 SE) PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION WHICH ALLOWS FOR NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT SPECTACLES.
P890047|S017|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice||N|07/06/2005|07/29/2005|||OK30|CHANGE IN THE BACTERIAL MASTER SEED STORAGE MEDIA USED BY THE VENDOR.
P840064|S028|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE, PROVISC PACKAGED IN DUOVISC VISCOELASTIC SYSTEM AND DISCOVISC OPHTHALMIC VISCO|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2005|07/29/2005|||OK30|CHANGE IN THE BACTERIAL MASTER SEED STORAGE MEDIA USED BY THE VENDOR.
P010012|S055|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 MODELS H170, H173 & H175 AND CONTAK RENEWAL 3 HE MODELS H177 & H179|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2005|07/29/2005|||APPR|APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
P960040|S066|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM 2 DR AICD MODEL 1861|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2005|07/29/2005|||APPR|APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
P000046|S011|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|SHELLGEL SODIUM HYALURONATE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/07/2005|08/03/2005|||APPR|APPROVAL FOR THE CHANGE IN LABELING TO INCLUDE CANNULA ASSEMBLY INSTRUCTIONS AND FOUR ADDITION LANGUAGES.
P030007|S001|CARESTREAM HEALTH,INC.|150 Verona Street||ROCHESTER|NY|14608||Analyzer,medical image|MAMMOGRAPHY CAD ENGINE|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2005|09/16/2005|||APPR|APPROVAL FOR MINOR UPDATED TO THE COMPUTER-ASSISTED DETECTION ALGORITHMS.
P910073|S052|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE ACTIVE FIX AND PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2005|08/03/2005|||OK30|ADDITION OF A SIGHT HOLE IN ONE SIDE OF THE ELECTRODE BASE.
P960043|S057|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/11/2005|08/11/2005|||APPR|APPROVAL FOR REVISED INSTRUCTIONS FOR USE.
P980035|S044|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|KAPPA 700/650/600, KAPPA 900/800 AND ENPULSE E1/E2|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2005|07/26/2005|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE IPG REED SWITCH.
P010012|S056|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2005|08/16/2005|||APPR|APPROVAL FOR 1) AN ALTERNATE MAGNETIC REED SWITCH MANUFACTURED BY HERMETIC AND AN ASSOCIATED CHANGE TO THE EQUIPMENT USED IN THE REWORK OF THIS COMPONENT (ONLY IN CONTAK RENEWAL 3 RF MODELS H210, H215, H250 & H255 AND CONTAK RENEWAL 3 RF HE MODELS H217, H219, H257, & H259); AND 2) CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12.
P010012|S057|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2005|07/27/2005|||APPR|APPROVAL FOR 1) AN ALTERNATE MAGNETIC REED SWITCH MANUFACTURED BY HERMETIC AND AN ASSOCIATED CHANGE TO THE EQUIPMENT USED IN THE REWORK OF THE COMPONENT; AND 2) PROGRAMMER SOFTWARE APPLICATION MODEL 2845 V2.8.
P960040|S067|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE MODELS T180 AND T182|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2005|07/27/2005|||APPR|APPROVAL FOR 1) AN ALTERNATE MAGNETIC REED SWITCH MANUFACTURED BY HERMETIC AND AN ASSOCIATED CHANGE TO THE EQUIPMENT USED IN THE REWORK OF THE COMPONENT; AND 2) PROGRAMMER SOFTWARE APPLICATION MODEL 2845 V2.8.
P020031|S002|MICROSULIS MEDICAL LTD.|PARKLANDS BUSINESS PARK||DENMEAD HAMPSHIRE||PO7 6||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM|MNB|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2005|10/14/2005|||APPR|APPROVAL FOR REVISED PATIENT LABELING.
P040020|S001|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR NATURAL IOL MODELS SN60D3 AND MN60D3|MFK|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2005|07/29/2005|||APPR|APPROVAL FOR ACRYSOF RESTOR NATURAL INTRAOCULAR LENS (IOL) MODELS SN60D3 AND MN60D3 (LEVEL A MODIFICATION: ADDITION OF CHROMOPHORE).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF RESTOR NATURAL IOL AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO THE REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE.  THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P000044|S007|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR/CONFIRMATORY KIT|LOM|MI|30-Day Notice||N|07/13/2005|08/08/2005|||OK30|CHANGE IN RAW REAGENT SUPPLIER AND MATERIAL SPECIFICATIONS.
P020024|S005|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/2005|10/13/2005|||APPR|Approval for changes to the labeling to support compatibility of the devices with MR environments up to 3.0 Tesla.  The device, as modified, will be marketed under the trade name AMPLATZER Duct Occluder Device with the following indications for use: The AMPLATZER Duct Occluder Device is indicated for the non-surgical closure of patent ductus arteriosus (PDA).
P000039|S010|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE|MAE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/2005|10/13/2005|||APPR|Approval for changes to the labeling to support compatibility of the devices with MR environments up to 3.0 Tesla.  The device, as modified, will be marketed under the trade name AMPLATZER Septal Occluder (ASO) Device with the following indications for use: The AMPLATZER Septal Occluder (ASO) Device is indicated for the occlusion of atrial septal defects (ASD) in secundum position.  The ASO device is also indicated in patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration.  Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i.e., 1.5:1 degree of left to right shunt or RV enlargement).
P830055|S090|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/2005|09/26/2005|||APPR|APPROVAL TO: CHANGE THE NAME OF THE LCS COMPLETE M1 PS FEMORAL COMPONENT TO THE LCS COMPLETE RPS FEMORAL COMPONENT, ADD NEW SIZES ALONG WITH SOME MINOR DESIGN CHANGES TO THE RPS FEMORAL COMPONENTS, CHANGE THE NAME OF THE LCS COMPLETE M1 PS TIBIAL BEARING COMPONENT TO THE LCS COMPLETE RPS TIBIAL BEARING COMPONENT, ADD NEW BEARING THICKNESSES TO THE RPS TIBIAL BEARING COMPONENTS, AND MAKE DIMENSIONAL CHANGES TO THE TIBIAL REINFORCEMENT PIN USED WITH THE RPS TIBIAL BEARINGS; CHANGE THE CAM AND SPINE MECHANISMS FOR THE LCS COMPLETE REVISION FEMORAL AND TIBIAL BEARING COMPONENTS, ADD A MEDIUM SIZE TO THE LCS COMPLETE REVISION FEMORAL AND TIBIAL BEARING COMPONENTS, CHANGE THE NAME OF THE LCS COMPLETE REVISION TIBIAL BEARING COMPONENT FROM VVC1 TO VVC, AND MODIFY THE TIBIAL REINFORCEMENT PIN USED WITH THE VVC TIBIAL BEARINGS.
P030045|S001|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, ILIAC|INTRASTENT DOUBLE STRUT STENT|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2005|02/28/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT EV3, INC., PLYMOUTH, MINNESOTA AND A NEW STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC.MINNEAPOLIS, MINNESOTA.
P000040|S006|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/2005|09/21/2005|||APPR|APPROVAL FOR THE ADDITION OF THE TENACULUM STABILIZER COMPONENT TO THE HTA PROCEDURE SET AND FOR CHANGES TO THE PACKAGING, SHELF-LIFE AND LABELING ASSOCIATED WITH THE ADDITION OF THE COMPONENT.
P020026|S014|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/2005|05/17/2006|||APPR|APPROVAL TO IMPLEMENT NEW ORTHOGONAL METHODS TO QUANTITATE DRUG CONTENT, IMPURITIES AND DEGRADATION PRODUCTS FOR THE CYPHER STENT.  BASED UPON THESE NEW METHODS, YOU HAVE ALSO REQUESTED APPROVAL FOR NEW SPECIFICATIONS FOR IMPURITIES AND DEGRADATION PRODUCTS FOR THE CYPHER STENT AT FINISHED GOODS RELEASE TESTING AND ON STABILITY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS OF LENGTH <= 30MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETER OF >= 2.5 MM TO <= 3.5 MM.
P860057|S029|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2005|08/29/2008|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING MODIFICATIONS TO THE CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESES, MODELS 6900P AND 6900PTFX INCLUDING CHANGES TO THE ELGILOY BAND, THE POLYESTER BAND, AND THE SILICONE WAFFLE SEWING RING/CUFF.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESES, MODELS 7000 AND 7000TFX AND IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC MITRAL VALVES.
P010001|S002|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2005|12/12/2005|||APPR|APPROVAL FOR A CHANGE IN THE POLISHING AND LAPPING MANUFACTURING PROCESS AND EQUIPMENT.
P010041|S009|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2005|10/07/2005|||APPR|APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.
P020025|S012|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|MAESTRO 3000 TM CARDIAC ABLATION SYSTEM|OAD|CV|Normal 180 Day Track||N|07/18/2005|10/18/2005|||APPR|APPROVAL FOR MODIFICATION TO THE HARDWARE, SOFTWARE, AND NEW ACCESSORIES OF THE EPT-1000 SERIES OF CARDIAC ABLATION SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAESTRO 3000 CARDIAC ABLATION SYSTEM AND IS INDICATED FOR USE, IN CARDIAC ABLATION PROCEDURES, WITH STANDARD AND HIGH-POWER BSC CARDIAC ABLATION CATHETERS SUCH THAT THE PHYSICIAN IS REFERRED TO THE INDIVIDUAL INSTRUCTIONS FOR USE FOR CATHETER COMPATIBILITY TO THE MAESTRO 3000 CARDIAC ABLATION SYSTEM.  THE BOSTON SCIENTIFIC CORPORATION ABLATION CATHETERS WHICH ARE COMPATIBLE WITH THE MAESTRO CARDIAC ABLATION SYSTEM ARE THE BLAZER II/BLAZER II HTD, BLAZER II XP, BLAZER RPM , BLAZER XP RPM, POLARIS T/POLARIS T HTD, CHILLI II, AND STEEROCATH-T.
P920047|S028|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|MAESTRO 3000 CARDIAC ABLATION SYSTEM & CATHETERS|LPB|CV|Normal 180 Day Track||N|07/18/2005|10/18/2005|||APPR|APPROVAL FOR MODIFICATION TO THE HARDWARE, SOFTWARE, AND NEW ACCESSORIES OF THE EPT-1000 SERIES OF CARDIAC ABLATION SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAESTRO 3000 CARDIAC ABLATION SYSTEM AND IS INDICATED FOR USE, IN CARDIAC ABLATION PROCEDURES, WITH STANDARD AND HIGH-POWER BSC CARDIAC ABLATION CATHETERS SUCH THAT THE PHYSICIAN IS REFERRED TO THE INDIVIDUAL INSTRUCTIONS FOR USE FOR CATHETER COMPATIBILITY TO THE MAESTRO 3000 CARDIAC ABLATION SYSTEM.  THE BOSTON SCIENTIFIC CORPORATION ABLATION CATHETERS WHICH ARE COMPATIBLE WITH THE MAESTRO CARDIAC ABLATION SYSTEM ARE THE BLAZER II/BLAZER II HTD, BLAZER II XP, BLAZER RPM , BLAZER XP RPM, POLARIS T/POLARIS T HTD, CHILLI II, AND STEEROCATH-T.
P980003|S016|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|MAESTRO 3000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track||N|07/18/2005|10/18/2005|||APPR|APPROVAL FOR MODIFICATION TO THE HARDWARE, SOFTWARE, AND NEW ACCESSORIES OF THE EPT-1000 SERIES OF CARDIAC ABLATION SYSTEMS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAESTRO 3000 CARDIAC ABLATION SYSTEM AND IS INDICATED FOR USE, IN CARDIAC ABLATION PROCEDURES, WITH STANDARD AND HIGH-POWER BSC CARDIAC ABLATION CATHETERS SUCH THAT THE PHYSICIAN IS REFERRED TO THE INDIVIDUAL INSTRUCTIONS FOR USE FOR CATHETER COMPATIBILITY TO THE MAESTRO 3000 CARDIAC ABLATION SYSTEM.  THE BOSTON SCIENTIFIC CORPORATION ABLATION CATHETERS WHICH ARE COMPATIBLE WITH THE MAESTRO CARDIAC ABLATION SYSTEM ARE THE BLAZER II/BLAZER II HTD, BLAZER II XP, BLAZER RPM , BLAZER XP RPM, POLARIS T/POLARIS T HTD, CHILLI II, AND STEEROCATH-T.
P000007|S009|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2005|10/07/2005|||APPR|APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.
P870077|S020|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2005|10/07/2005|||APPR|APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.
P870056|S022|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2005|10/07/2005|||APPR|APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.
P900009|S021|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN BONE HEALING SYSTEM 2000 ,3000|LPQ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/2005|12/19/2008|||APPR|APPROVAL FOR LABELING MODIFICATIONS AIMED TO SIMPLIFY THE DEVICE LABELING.
P860057|S030|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2005|10/07/2005|||APPR|APPROVAL FOR THE ALTERNATIVE 3.8 OZ. SIZE JAR AND THE PRE-PRINTED CARDBOARD CARTON.
P040043|S006|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|07/19/2005|08/31/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970003|S058|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM, MODEL 302|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/2005|09/29/2005|||APPR|APPROVAL FOR CHANGES TO THE MODEL 302 LEAD PHYSICIAN'S MANUAL CLARIFYING INFORMATION REGARDING HANDLING TO AVOID DAMAGE TO THE LEAD AND HELICAL ELECTRODES.
P020030|S002|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|STELIX II ENDOCARDIAL PACING LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2005|12/29/2005|||APPR|APPROVAL FOR ADDITIONAL INCOMING ACCEPTANCE AND FINAL DEVICE TESTING.
P990050|S006|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD,SUITE|11|SAN DIEGO|CA|92121||ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)|WAVSTAT OPTICAL BIOPSY SYSTEM|MOA|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2005|03/28/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC., SAN DIEGO, CALIFORNIA.
P860003|S043|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2005|08/19/2005|||APPR|APPROVAL FOR A NEW CENTRIFUGE LEAK SENSOR.
P020045|S011|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2005|11/18/2005|||APPR|APPROVAL FOR CHANGES IN INTERNAL QUALITY INSPECTION AND CONTROLS PROCESS TO ADD NEW FIT TEST METHODS TO SPECIFIED INCOMING COMPONENTS.
P890014|S008|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|ETI-HA-IGMK PLUS KIT|LOL|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/20/2005|12/14/2005|||APPR|APPROVAL FOR CHANGE TO THE ASSAY CUTOFF CALCULATION THAT IS DESIGNED TO REDUCE THE NUMBER OF LOW LEVEL, NON-CLINICALLY RELEVANT POSITIVE RESULTS REPORTED BY THE ETI-HA-IGMK PLUS ASSAY.
P950039|S016|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2005|01/18/2006|||APPR|APPROVAL FOR ADDITIONAL CLAIMS TO THE CURRENT LABELING.  THE ADDITIONAL CLAIMS CONSIST OF EXTENSION OF THE EXPIRATION DATE OF THE PRESERVCYT SAMPLE VIALS TO SIX WEEKS, REPROCESSING "UNSATISFACTORY FOR EVALUATION" SLIDES WITH A CYTOLYT SOLUTION AND GLACIAL ACETIC ACID WASH, AND REFERENCE TO THE GEN-PROBE APTIMA ASSAYS FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE.
P990055|S008|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|BAYER ADVIA IMS COMPLEXED PSA ASSAY|NAF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2005|10/07/2005|||APPR|APPROVAL OF THE ACS:180 AND THE CENTAUR COMPLEXED PSA (CPSA) ASSAYS ON THE ADVIA CENTAUR CP SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR CP CPSA AND IS INDICATED:  THE IN VITRO DIAGNOSTIC ASSAY IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM USING THE ADVIA CENTAUR SYSTEM.  THE ASSAY IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER.  BIOPSY OF THE PROSTATE IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER.  THE ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
P950021|S007|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ADVIA CENTAUR CP PSA ASSAY|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2005|10/07/2005|||APPR|APPROVAL FOR TRANSFER OF THE ASSAY TO A NEW BAYER PLATFORM, THE ADVIA CENTAUR CP SYSTEM.  THE ADVIA CENTAUR CP PSA ASSAY IS INTENDED TO QUANTITATIVELY MEASURE PROSTATE-SPECIFIC-ANTIGEN (PSA) IN HUMAN SERUM USING THE ADVIA CENTAUR CP SYSTEM.
P930036|S003|SIEMENS HEALTHCARE DIAGNOSTICS INC.|333 CONEY  STREET||EAST WALPOLE|MA|02032||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2005|10/07/2005|||APPR|APPROVAL FOR THE ACS:180 AND THE CENTAUR AFP ASSAYS ON THE ADVIA CENTAUR CP SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR CP AFP AND IS INDICATED FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN 1) HUMAN SERUM AND IN AMNIOTIC FLUID FROM SPECIMENS OBTAINED AT 15 AND 20 WEEKS GESTATION, AS AN AID IN DETECTING OPEN NEURAL TUBE DEFECTS (NTDS) WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY AND AMNIOGRAPHY TESTING 2) HUMAN SERUM, AS AN AID IN MANAGING NON-SEMINOMATOUS TESTICULAR CANCER WHEN USED IN CONJUNCTION WITH PHYSICAL EXAMINATION, HISTOLOGY/PATHOLOGY, AND OTHER CLINICAL EVALUATION PROCEDURES, USING THE (BAYER) SYSTEM.
P010003|S006|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2005|04/13/2006|||APPR|APPROVAL FOR TWO MANUFACTURING SITES: 1) CENTURION STERILIZATION SERVICES, PART OF TRI-STATE HOSPITAL SUPPLY, SALISBURY, NORTH CAROLINA FOR THE STERILIZATION OF BIOGLUE EXTENDER TIPS; AND 2) COMMAND MEDICAL PRODUCTS, ORMOND BEACH, FLORIDA AS A COMPONENT ASSEMBLER.
P860019|S205|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/25/2005|12/15/2005|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE DIRECTIONS FOR USE MANUALS (DFU) AND LABELS FOR ALL AFFECTED PTCA CATHETER SYSTEMS.
P880086|S105|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2005|08/25/2005|||OK30|ADDITION OF A SPOT LASER WELD TO THE RESISTANCE WELD THAT BONDS THE FEEDTHROUGH WIRE TO THE CONNECTOR WIRE.
P850020|S021|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC|PROSORBA COLUMN|LKN|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/2005|08/25/2005|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE ART HEMOADSORPTION SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.
P980016|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2005|09/30/2005|||APPR|APPROVAL TO VERIFY ADDITIONAL PROGRAMMING PARAMETERS AT THE POST-STERILIZATION MANUFACTURING STEP.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND ENRHYTHM IMPLANTABLE PULSE GENERATOR RESPECTIVELY.
P980035|S045|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2005|09/30/2005|||APPR|APPROVAL TO VERIFY ADDITIONAL PROGRAMMING PARAMETERS AT THE POST-STERILIZATION MANUFACTURING STEP.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND ENRHYTHM IMPLANTABLE PULSE GENERATOR RESPECTIVELY.
P880086|S106|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2005|08/25/2005|||OK30|CHANGE OF THE MANUAL EPOXY DISPENSING METHOD TO A SEMI-AUTOMATED ROBOT CONTROLLED EPOXY DISPENSING SYSTEM.
P000037|S007|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2005|08/25/2005|||OK30|CHANGE IN MANUFACTURING FOR THE ON-X VALVE THAT ENTAILS A FAMILY OF CHANGES TO CMM SOFTWARE AND RELATED PROCEDURES.
P980016|S053|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2005|08/19/2005|||APPR|APPROVAL FOR THE RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS FOR THE FOLLOWING MODELS: MEDTRONIC ENTRUST MODEL D153ATG;MEDTRONIC ENTRUST MODEL D153DRG;MEDTRONIC ENTRUST MODEL D153VRC;MEDTRONIC ENTRUST MODEL D154ATG;MEDTRONIC ENTRUST MODEL D154DRG; ANDMEDTRONIC ENTRUST MODEL D154VRC.
P010012|S059|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2005|08/25/2005|||OK30|ADDITION OF A STIFFENER FIXTURE AND FLUX DISPENSE TO THE REWORK PROCESS.
P980037|S014|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA THROMBECTOMY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/2005|12/07/2006|||APPR|APPROVAL FOR A REDESIGN OF THE DRIVE UNIT (ULTRA CONSOLE) AND TO COMBINE THE PUMP SET AND CATHETERS INTO A SINGLE THROMBECTOMY SET (WITH DIFFERENT MODELS CORRESPONDING TO THE CURRENT XMI AND XMI-RX CATHETER MODELS).
P960006|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|FLEXTEND LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2005|08/31/2005|||OK30|ADDITION OF HELIX INSPECTION CRITERIA TO THE MANUFACTURING INSTRUCTIONS.
P910073|S053|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2005|08/31/2005|||OK30|ADDITION OF HELIX INSPECTION CRITERIA TO THE MANUFACTURING INSTRUCTIONS.
P930038|S045|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2005|08/31/2005|||OK30|CHANGE TO USE THE SEMI-AUTOMATED BACK HALF MACHINE SYSTEM.
P990012|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2005|09/22/2005|||APPR|APPROVAL FOR CHANGES TO THE CALIBRATOR AND CONTROL RECOVERY RANGES.
P030025|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/02/2005|09/24/2008|||APPR|APPROVAL FOR STENT DIAMETERS WHICH EXPAND THE PRODUCT MATRIX TO INCLUDE 2.25 MM AND 4.0MM TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS. THE DEVICE, ASMODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TAXUS EXPRESS2 PACLITAXEL-ELUTINGCORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW) AND IS INDICATED FOR THEFOLLOWING: THE TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVINGLUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >2.25 TO<4.0MM IN DIAMETER IN LESIONS < 28MM IN LENGTH.
P990045|S008|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2005|08/29/2005|||OK30|CHANGE IN DETERMINATION OF SPECIFIC ATTRIBUTES OF QUALITY CONTROL FOR A RAW REAGENT.
P010012|S061|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3&4 FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2005|09/21/2005|||OK30|ADDITION OF AN AUTOMATED VISION SYSTEM (EQUIPMENT) TO THE INSPECTION PROCESS FOR INSPECTION OF HEADERS THAT WILL REPLACE THE MANUAL VISUAL INSPECTION PROCESS TO THE FAMILY OF CRT AND ICD DEVICES.
P960040|S069|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2005|09/21/2005|||OK30|ADDITION OF AN AUTOMATED VISION SYSTEM (EQUIPMENT) TO THE INSPECTION PROCESS FOR INSPECTION OF HEADERS THAT WILL REPLACE THE MANUAL VISUAL INSPECTION PROCESS TO THE FAMILY OF CRT AND ICD DEVICES.
P000032|S012|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|08/04/2005|09/21/2005|||APPR|APPROVAL FOR A CHANGE IN MATERIAL TO THE PRECOOL FINNED TUBING AND THE MIXED GAS FINNED TUBING FROM 304 STAINLESS STEEL TO INCONEL 625
P990037|S023|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT...|MGB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2005|09/02/2005|||APPR|APPROVAL TO MODIFY THE PROCEDURE FOR DETERMINING ACCEPTANCE OF THE LIMULUS AMEBOCYTE LEVEL (LAL) TEST RESULTS.
P840001|S080|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2005|09/23/2005|||APPR|APPROVAL FOR THE MODEL 37083, SINGLE QUADPOLAR EXTENSION KIT.
P870025|S008|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|FETAL ACOUSTIC STIMULATOR|MCP|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2005|03/02/2006|||APPR|APPROVAL FOR VENDOR CHANGES FOR THE FOLLOWING COMPONENTS: DIE CAST FRAME AND PRINTED CIRCUIT BOARD (PCB) AND A CHANGE IN ADHESIVE MATERIAL.
P910023|S081|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/2005|05/11/2006|||APPR|APPROVAL FOR THE CONVERT AND CONVERT+ ICD SYSTEMS WITH THE APPLICATION SOFTWARE MODEL 3307 VERSION 4.9.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONVERT AND CONVERT+ ICD SYSTEMS AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (MODEL V-195 ONLY) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P010012|S062|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2005|09/07/2005|||OK30|UPGRADE THE TORQUE SETSCREW SYSTEM SOFTWARE FROM V2.0 TO V3.0.
P960040|S070|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND VENTAK PRIZM 2 AUTOMATIC IMPLANTABLE CARDIOVERT..|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2005|09/07/2005|||OK30|UPGRADE THE TORQUE SETSCREW SYSTEM SOFTWARE FROM V2.0 TO V3.0.
P940031|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY,MERIDIAN PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2005|09/07/2005|||OK30|UPGRADE THE TORQUE SETSCREW SYSTEM SOFTWARE FROM V2.0 TO V3.0.
P000008|S008|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/2005|02/02/2006|||APPR|APPROVAL FOR AN OPTIONAL ACCESSORY DEVICE, THE RAPIDPORT SYSTEM, TO BE USED WITH THE LAGB SYSTEM ACCESS PORT II.
P030025|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2005|08/31/2005|||OK30|REMOVAL OF A "PESTICIDE RESIDUE TEST" FROM THE INCOMING RAW MATERIAL SPECIFICATION FOR TOLUENE USED IN THE STENT COATING PROCESS.
P840064|S029|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2005|09/21/2005|||APPR|APPROVAL FOR REPLACEMENT OF THE MATERIAL OF THE TIP CAP AND STOPPER FOR LATEX-FREE RUBBER COMPONENTS.
P030005|S011|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2005|09/09/2005|||OK30|ADDING A SECOND SUPPLIER, MICROCRYSTAL, FOR THE PIEZOELECTRIC QUARTZ CRYSTAL COMPONENT USED IN THE CONTAK RENEWAL TR DEVICES.
P960040|S072|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITAITY HE MODELS T180 & T182, AND VENTAK PRIZM 2 VR MODEL 1860 AICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/11/2005|09/22/2005|||APPR|APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
P030005|S012|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2005|09/07/2005|||OK30|ADD A SUPPORT FIXTURE TO THE BONDING PROCESS OF THE HEADER AND CASE.
P030005|S013|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR IS-1 FAMILY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2005|09/07/2005|||OK30|AUTOMATION OF THE PROCESS OF APPLYING THE MEDICAL ADHESIVE TO THE DEVICE HEADER AND AFFIXING THE HEADER TO THE DEVICE CASE.
P980035|S046|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC ENPULSE E1/E2 IMPLANTABLE PULSE GENERATOR DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/12/2005|09/15/2005|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE PACKAGE CONFIGURATION AND CHANGES TO THE LABEL STOCK.
P860004|S074|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE DRUG INFUSION PUMP|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2005|11/03/2005|||APPR|APPROVAL FOR ADDITION OF NUSIL 1137 SILICONE ADHESIVE TO THE CATHETER FITTING O-RING ASSEMBLY.
P960040|S073|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2005|09/07/2005|||OK30|CHANGE IN THE METHOD OF ATTACHING THE HEADER TO THE CAN INVOLVING ROUGHENING THE AREA OF ATTACHMENT TO IMPROVE BOND STRENGTH.
P010012|S064|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2005|09/07/2005|||OK30|CHANGE IN THE METHOD OF ATTACHING THE HEADER TO THE CAN INVOLVING ROUGHENING THE AREA OF ATTACHMENT TO IMPROVE BOND STRENGTH.
P930016|S023|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/12/2005|09/28/2005|||APPR|APPROVAL FOR MINOR DESIGN AND LABELING CHANGES INCLUDED IN WAVESCAN SOFTWARE, VERSION 3.65.
P000032|S013|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CYROABLATION THERAPY SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2005|07/03/2006|||APPR|APPROVAL FOR: 1) UPDATES TO THE SOFTWARE, I.E., IN-ICE DETECTION; 2) IMPROVEMENT IN THE LOCKING TABS; AND 3) LABELING CHANGES.
P910007|S015|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ABBOTT IMX TOTAL PSA, ABBOTT AXSYM TOTAL PSA AND ABBOTT ARCHITECT TOTAL PSA|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/12/2005|09/13/2005|||APPR|APPROVAL FOR ADDITION OF A BIAS ANALYSIS STUDY TO THE REAGENT PACKAGE INSERTS.
P030005|S014|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR MODELS H120 AND H125|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2005|09/13/2005|||OK30|UPDATED INSPECTION CRITERIA FOR BUBBLES WITHIN THE MEDICAL ADHESIVE IN THE HEADER ASSEMBLY.
P030005|S015|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR MODELS H120 AND H125|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2005|09/08/2005|||OK30|CHANGES MADE TO THE SOFTWARE OF THE AUTOMATED SETSCREW PRELOAD SYSTEM FOR THE MODELS LISTED THAT WERE INADVERTENTLY LEFT OU OF A PREVIOUS 30-DAY NOTICE.
P940031|S040|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2005|09/07/2005|||OK30|IMPLEMENTATION OF A DIE SCREEN INSPECTION AND ADDITION OF A CRATERING FAILURE MODE FOR THIS INSPECTION.
P010012|S065|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2005|09/07/2005|||OK30|IMPLEMENTATION OF A DIE SCREEN INSPECTION AND ADDITION OF A CRATERING FAILURE MODE FOR THIS INSPECTION.
P960040|S074|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2005|09/07/2005|||OK30|IMPLEMENTATION OF A DIE SCREEN INSPECTION AND ADDITION OF A CRATERING FAILURE MODE FOR THIS INSPECTION.
P010012|S066|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2005|11/24/2005|||APPR|APPROVAL FOR THE USE OF FOUR NEW INNER LEAD BONDING (ILB) MACHINES ON THE TAPE AUTOMATED BONDING (TAB) MANUFACTURING LINE FOR PULSE GENERATORS.
P960040|S075|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM FAMILY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2005|11/24/2005|||APPR|APPROVAL FOR THE USE OF FOUR NEW INNER LEAD BONDING (ILB) MACHINES ON THE TAPE AUTOMATED BONDING (TAB) MANUFACTURING LINE FOR PULSE GENERATORS.
P860004|S075|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED IMPLANTABLE INFUSION SYSTEM|LKK|HO|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2005|12/23/2005|||APPR|APPROVAL FOR A MODIFIED CLEANING PROCESS OF THE PLATINUM/IRIDIUM CATHETER TIP OF THE MODEL 8731 CATHETER.
P940031|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY|LWP|CV|30-Day Notice||N|08/15/2005|09/13/2005|||OK30|ADDITION OF AN INLINE TEMPERATURE AND HUMIDITY CONTROLLED CURE TUNNEL TO FILL CHANNELS.
P960040|S076|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM|LWP|CV|30-Day Notice||N|08/15/2005|09/13/2005|||OK30|ADDITION OF AN INLINE TEMPERATURE AND HUMIDITY CONTROLLED CURE TUNNEL TO FILL CHANNELS.
P010012|S067|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL/CD 2/RENEWAL RF FAMILIES|LWP|CV|30-Day Notice||N|08/15/2005|09/13/2005|||OK30|ADDITION OF AN INLINE TEMPERATURE AND HUMIDITY CONTROLLED CURE TUNNEL TO FILL CHANNELS.
P030005|S016|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice||N|08/15/2005|09/13/2005|||OK30|ADDITION OF AN INLINE TEMPERATURE AND HUMIDITY CONTROLLED CURE TUNNEL TO FILL CHANNELS.
P960040|S077|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM 2 DR/ VR PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2005|09/08/2005|||OK30|ADDITION OF A HYBRID INSPECTION STEP FOR LIFTED OR CRACKED PADS DURING THE REWORK PROCESS.
P960040|S078|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV FAMILY (INCLUDES PRIZM AND VITALITY FAMILIES)|LWP|CV|Special (Immediate Track)|Other Report|N|08/16/2005|06/22/2012|||APPR|APPROVAL FOR THE MINOR MANUFACTURE CHANGES OF THE DEVICES.
P960040|S079|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTALITY FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2005|09/15/2005|||OK30|TEST MODIFICATIONS FOR THE HIGH VOLTAGE POWER MODULES IN THE VITALITY AND RENEWAL DS ICDS.
P010012|S068|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2005|09/15/2005|||OK30|TEST MODIFICATIONS FOR THE HIGH VOLTAGE POWER MODULES IN THE VITALITY AND RENEWAL DS ICDS.
P010012|S069|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD FAMILY (INCLUDES RENEWAL FAMILY)|LWP|CV|Special (Immediate Track)|Other Report|N|08/16/2005|06/22/2012|||APPR|APPROVAL FOR THE MINOR MANUFACTURE CHANGES OF THE DEVICES.
P040005|S001|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 FISH PHARMDX KIT|MVD|PA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|08/15/2005|04/21/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARKS A/S, GLOSTRUP, DENMARK.
P870038|S007|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|STARR EDWARDS SILASTIC BALL VALVE, MODELS 1260 AND 6120|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2005|09/13/2005|||OK30|APPROVAL FOR A CHANGE IN SUPPLIER OF THE PTFE MONOFILAMENT SEWING THREAD FROM W.L. GORE TO LENZING AG.
P010051|S003|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC|LOM|MI|Special (Immediate Track)||N|08/17/2005|11/02/2005|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS WHICH ADD AN INCOMING RAW MATERIAL TEST.
P010052|S003|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS|LOM|MI|Special (Immediate Track)||N|08/17/2005|11/02/2005|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS WHICH ADD AN INCOMING RAW MATERIAL TEST.
P010053|S003|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2005|11/02/2005|||APPR|APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS WHICH ADD AN INCOMING RAW MATERIAL TEST.
P010068|S006|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/2005|08/29/2006|||APPR|APPROVAL FOR USING A NEW HANDLE, PULLER WIRES AND 1 MM LOCATION SENSOR.
P950005|S019|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER AND EZ STEER DS BIDIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/2005|08/29/2006|||APPR|APPROVAL FOR USING A NEW HANDLE AND PULLER WIRES.
P960040|S080|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM 2|LWP|CV|30-Day Notice||N|08/19/2005|09/15/2005|||OK30|CHANGE TO THE LIFTED POSITIVE DF (DF+) PAD INSPECTION PROCESS.
P010012|S070|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2005|09/15/2005|||OK30|CHANGE TO THE LIFTED POSITIVE DF (DF+) PAD INSPECTION PROCESS.
P990081|S002|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY|MVC|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/06/2005|10/21/2005|||APPR|APPROVAL OF LABELING CHANGES FOR THE PATHWAY HER-2/NEU (CLONE CD11) IN THE "INTENDED USE" SECTION, ADDITION OF AN "OPTIONAL EQUIPMENT NOT PROVIDED" SECTION AND CHANGES TO THE "PRINCIPLES AND PROCEDURES" SECTION TO REFLECT THE ADDITION OF TRIPATH IMAGING VIAS INSTRUMENT TO BE USED IN CONJUNCTION WITH THE VENTANA PATHWAY HER 2 ASSAY AS AN OPTIONAL ACCESSORY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME PATYHWAY HER-2/NEU (CLONE CD11) AND IS INDICATED: VENTANA MEDICAL SYSTEMS, INC.'S (VENTANA) PATHWAY HER 2 (CLONE CD11) IS A MOUSE MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF C-ERBB2- ANTIGEN IN SECTIONS OF FORMALIN FIXED, PARAFFIN EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEM-ISTRY SLIDE STAINING DEVICE.  IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN TREATMENT IS CONSIDERED.  NOTE: ALL OF THE PATIENTS IN THE HERCEPTIN CLINICAL TRIALS WERE SELECTED USING A CLINICAL TRIAL ASSAY.  NONE OF THE PATIENTS IN THOSE TRIALS WERE SELECTED USING PATHWAY HER 2.  THE PATHWAY HER 2 WAS COMPARED TO THE DAKO HERCEPTEST ON AN INDEPENDENT SAMPLE AND FOUND TO PROVIDE ACCEPTABLY CONCORDANT RESULTS.  THE ACTUAL CORRELATION OF PATHWAY HER 2 TO CLINICAL OUTCOME HAS NOT BEEN ESTABLISHED.  THE VENTANA IMAGE ANALYSIS SYSTEM (VIAS) IS ADJUNCTIVE OPTIONAL COMPUTER-ASSISTED IMAGE ANALYSIS SYSTEM FUNCTIONALLY CONNECTED TO AN INTERACTIVE MICROSCOPE.  IT IS INTENDED FOR USE AS AN AID TO THE PATHOLOGIST IN THE DETECTION CLASSIFICATION AND COUNTING OF CELLS OF INTEREST BASED ON MARKET INTENSITY, SIZE AND SHAPE USING APPROPRIATE CONTROLS TO ASSURE THE VALIDITY OF THE VIAS SCORES.
P890003|S088|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC PACEMAKER SYSTEMS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2005|09/21/2005|||APPR|APPROVAL FOR A FIRMWARE UPGRADE OF THE BATTERYCHECK MONITOR WHICH WILL IMPROVE TELEMETRY COMMUNICATION WITH THE IMPLANTED DEVICE.
P980016|S054|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2005|09/21/2005|||APPR|APPROVAL FOR A FIRMWARE UPGRADE OF THE BATTERYCHECK MONITOR WHICH WILL IMPROVE TELEMETRY COMMUNICATION WITH THE IMPLANTED DEVICE.
P010031|S025|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2005|09/21/2005|||APPR|APPROVAL FOR A FIRMWARE UPGRADE OF THE BATTERYCHECK MONITOR WHICH WILL IMPROVE TELEMETRY COMMUNICATION WITH THE IMPLANTED DEVICE.
P840001|S081|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC NEUROSTIMULATION SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2005|10/20/2005|||APPR|APPROVAL FOR THE MODEL 3550-39 TITAN ANCHOR ACCESSORY KIT.
P030002|S005|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL)|NAA|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/2005|09/26/2005|||APPR|APPROVAL FOR CHANGES IN THE ?RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES? SECTION OF THE PHYSICIANS LABELING.
P960040|S082|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2005|09/23/2005|||OK30|CHANGE IN THE MANUFACTURING PROCESS ELIMINATING VACCUUM BAKE AND INSPECTION AND THE FIRST SHELF TEST STEP.
P010012|S072|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2005|09/23/2005|||OK30|CHANGE IN THE MANUFACTURING PROCESS ELIMINATING VACCUUM BAKE AND INSPECTION AND THE FIRST SHELF TEST STEP.
P040003|S001|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ultrasound,hyperthermia, cancer treatment|EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM|LSY|OB|Normal 180 Day Track No User Fee|Express GMP Supplement|N|08/25/2005|12/30/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INSIGHTEC IMAGE GUIDED TREATMENT LTD., TIRAT CARMEL, ISRAEL.
P910073|S054|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2005|09/23/2005|||OK30|CHANGE IN THE MANUFACTURING PROCESS THAT ADDS A DRUG COLLAR INSPECTION TO THE ASSEMBLY AND BONDING MANUFACTURING INSTRUCTION FOR THE LEADS.
P960040|S083|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PROGRAMMER SOFTWARE APPLICATION MODEL 2812, VERSION 1.4|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2005|03/23/2007|||APPR|APPROVAL FOR VITALITY AVT PROGRAMMER SOFTWARE (SW) MODEL 2812V1.4 AND THE APPLICABLE FIRMWARE FOR USE ON TE MODEL 2920 PROGRAMMER.
P960040|S084|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PROGRAMMER SOFTWARE APPLICAION MODEL 2812, VERSION 2.1|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2005|03/23/2007|||APPR|APPROVAL FOR VITALITY AVT PROGRAMMER SOFTWARE (SW) MODEL 2812V2.1 AND THE APPLICABLE FIRMWARE FOR USE ON TE MODEL 3120 PROGRAMMER.
P940031|S043|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2005|09/27/2005|||OK30|MODIFICATION IN THE PIN GAUGE TOOL.
P010012|S073|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2005|09/27/2005|||OK30|MODIFICATION IN THE PIN GAUGE TOOL.
P030005|S018|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2005|09/27/2005|||OK30|MODIFICATION IN THE PIN GAUGE TOOL.
P960040|S085|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2005|09/27/2005|||OK30|MODIFICATION IN THE PIN GAUGE TOOL.
P030030|S003|C.R. Bard, Inc.|13183 HARLAND DRIVE||COVINGTON|GA|30014|6421|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|BARD TEGRESS URETHRAL IMPLANT|LNM|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/29/2005|05/23/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE POSTAPPROVAL STUDY PROTOCOL.
P040029|S001|Euclid Systems Corporation|2776 Towerview Rd.||Herndon|VA|20171||Lens, contact, orthokeratology, overnight|JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR|NUU|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2005|10/14/2005|||APPR|APPROVAL FOR A PROTOCOL OF ACCEPTABLE PROCEDURES TO ALLOW ONE OR MORE INDEPENDENT FINISHING LABORATORIES TO MANUFACTURE AND DISTRIBUTE FINISHED RGP CONTACT LENSES FOR OVERNIGHT ORTHOKERATOLOGY MADE FROM LENS BLANKS.
P940031|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2005|06/28/2006|||APPR|APPROVAL FOR THE ADDITION OF INSPECTION CRITERIA TO ALLOW FOR SOLDER BALLS UNDER COMPONENTS ON THE HYBRID.
P030005|S019|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENWAL TR2|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2005|06/28/2006|||APPR|APPROVAL FOR THE ADDITION OF INSPECTION CRITERIA TO ALLOW FOR SOLDER BALLS UNDER COMPONENTS ON THE HYBRID.
P010032|S017|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2005|11/16/2005|||APPR|APPROVAL FOR THE RAPID PROGRAMMER, MODELS 3830 AND 3831, WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P830055|S091|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2005|09/12/2005|||APPR|APPROVAL FOR A CHANGE IN THE CRITERIA USED IN THE MANUFACTURE OF THE REFERENCED COMPONENTS.  THIS MODIFICATION ADDS A STEP TO THE INSPECTION PROCEDURE BY UTILIZING A GAGE TO AID IN THE INSPECTION OF THE SPIRALOCK TAPPED HOLE PRIOR TO TAPPING.
P030009|S003|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MEDTRONIC VASCULAR DRIVER RAPID EXCHANGE CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/29/2005|12/22/2005|||APPR|APPROVAL FOR A SERIES OF MANUFACTURING CHANGES TO THE MEDTRONIC VASCULAR DRIVER RAPID EXCHANGE CORONARY STENT SYSTEM.
P970003|S059|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/12/2005|11/08/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880086|S108|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610|KRG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2005|12/07/2005|||APPR|APPROVAL FOR THE VICTORY PULSE GENERATOR MODELS XL DR 5816, DR 5810 AND SR 5610.
P040034|S001|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/2005|10/25/2005|||APPR|APPROVAL FOR AN EXTENSION OF THE PRODUCT EXPIRATION DATE TO 18 MONTHS.
P020022|S003|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2005|02/17/2006|||APPR|APPROVAL FOR CHANGES IN THE PRODUCTION OF THE CAPTURE WELLS.
P970018|S010|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|09/01/2005|09/28/2005|||APPR|APPROVAL FOR MODIFICATION TO THE SUREPATH SLIDE PREPARATION.
P000044|S008|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2005|09/22/2005|||OK30|CHANGE IN SUPPLIER FOR THE MANUFACTURE OF A COMPONENT USED IN THE MANUFACTURE OF THE VITROS HBSAG CALIBRATOR BY ORTHO-CLINICAL DIAGNOSTICS.
P920015|S032|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT FIDELIS LEADS MODELS,6949,6948,6931,6930|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2005|12/01/2005|||APPR|APPROVAL TO CHANGE THE AERATION TIME FOLLOWING STERILIZATION OF THE SPRINT FIDELIS LEADS.
P030022|S001|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/02/2005|11/17/2005|||APPR|APPROVAL FOR THE ADDITION OF THE ANTHOLOGY HIP STEM FOR USE WITH THE PREVIOUSLY APPROVED REFLECTION CERAMIC ACETABULAR SYSTEM.  THE DEVICE IS INDICATED FOR USE IN PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, OR TRAUMATIC ARTHRITIS.
P020041|S001|FEMCAP, INC.|14058 MIRA MONTANA DR.||DEL MAR|CA|92014|3455|CAP, CERVICAL, CONTRACEPTIVE|FEMCAP CONTRACEPTIVE BARRIER DEVICE|LLQ|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|09/02/2005|02/15/2006|||APPR|APPROVAL FOR A PROTOCOL TO EXTEND THE SHELF LIFE OF THE FEMCAP CONTRACEPTIVE BARRIER FROM THREE YEARS TO FIVE YEARS.
P040023|S001|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2005|02/01/2006|||APPR|APPROVAL FOR MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC. FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.
P010012|S074|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS|LWP|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2005|02/16/2006|||APPR|APPROVAL FOR THE ADDITION OF A CLARIFICATION AND INSPECTION STEP TO THE PROXIMAL ELECTRODE MANUFACTURING ASSEMBLY PROCESS FOR EASYTRAK LEADS.
P910073|S055|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE AND ENDOTAK ENDURANCE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2005|11/15/2005|||APPR|APPROVAL TO EXTEND THE SHELF LIFE OF THE DRUG PLUG COMPONENT OF THE LEADS FROM ONE YEAR TO THREE YEARS.  THE SHELF LIFE OF THE FINISHED LEADS REMAINS TWO YEARS.
P950001|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|SELUTE AND SELUTE PICOTIP|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2005|11/15/2005|||APPR|APPROVAL TO EXTEND THE SHELF LIFE OF THE DRUG PLUG COMPONENT OF THE LEADS FROM ONE YEAR TO THREE YEARS.  THE SHELF LIFE OF THE FINISHED LEADS REMAINS TWO YEARS.
P840001|S082|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/06/2005|11/04/2005|||APPR|APPROVAL FOR THE MODEL 3776 1X8 SC (SUBCOMPACT) LOW IMPEDANCE LEAD KIT AND THE MODEL 3876 1X8 SC LOW IMPEDANCE LEAD KIT.
P990020|S021|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2005|09/22/2005|||APPR|APPROVAL FOR THE ADDITION OF A NEW INSPECTION TEST.
P920047|S029|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CARDIAC ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2005|10/06/2005|||OK30|MODIFICATIONS TO MANUFACTURING PROCEDURES AND MANUFACTURING INSTRUCTIONS.
P020025|S013|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP, BLAZER XP RPM CARDIAC ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2005|10/06/2005|||OK30|MODIFICATIONS TO MANUFACTURING PROCEDURES AND MANUFACTURING INSTRUCTIONS.
P910071|S007|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)|LWL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/06/2005|12/16/2005|||APPR|APPROVAL FOR 1) CHANGE OF THE TIP CAP OF THE 10 ML HYPAC SCF SYRINGE FROM CONTAINING DRY NATURAL RUBBER MATERIAL TO LATEX-FREE MATERIAL AND 2) REVISION OF THE LABELING TO REMOVE THE "DRY NATURAL RUBBER" STATEMENT.
P970003|S060|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/31/2005|11/08/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030025|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2005|10/06/2005|||OK30|WIDENING OF THE UPPER TOLERANCE OF THE IN-PROCESS STENT TO MARKER BAND SPECIFICATION FOR THE DEVICE.
P980023|S020|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/2005|01/27/2006|||APPR|APPROVAL FOR THE LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS
P790019|S020|Abbott Laboratories|D-49C, BUILDING AP6C|100 ABBOTT PARK ROAD|ABBOTT PARK NORTH|IL|60064|3500|Hepatitis a test (antibody and igm antibody)|ABBOTT IMX HAVAB-M LIST 2263|LOL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2005|10/06/2005|||OK30|CHANGES IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, IMPLEMENTED TO IMPROVE MANUFACTURABILITY WITHOUT COMPROMISING PRODUCT PERFORMANCE.
P040021|S001|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|09/06/2005|08/03/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.
P900060|S034|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2005|11/30/2005|||APPR|APPROVAL TO SUBSTITUTE AN OUTSIDE VENDOR FOR SPECIFIC METAL COMPONENTS OF THE PROSTHETIC HEART VALVES.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES CARBOMEDICS PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP).
P030025|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2005|01/06/2006|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON, IRELAND, LTD, OFFALY, IRELAND.
P000046|S012|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II SODIUM HYALURONATE|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/2005|09/26/2005|||APPR|APPROVAL FOR THE CHANGE IN LABELING TO INCLUDE CANNULA ASSEMBLY INSTRUCTIONS.
P020026|S015|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2005|10/06/2005|||OK30|CHANGE FROM A MANUAL MEASUREMENT TO AN AUTOMATED PROCESS.
P010018|S008|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CK SYSTEM|MWD|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2005|09/30/2005|||OK30|IMPLEMENTATION OF A CONTROLLED ADHESIVE APPLICATION PROCESS TO MORE ACCURATELY CONTROL THE AMOUNT OF ADHESIVE APPLIED.
N17600|S023|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FOUR FAMILY|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2005|10/06/2005|||OK30|MANUFACTURING PROCESS CHANGES FOR THE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILIES OF DEVICES.
P800002|S015|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2005|10/06/2005|||OK30|MANUFACTURING PROCESS CHANGES FOR THE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILIES OF DEVICES.
P960030|S013|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|ISOFLEX S LEAD MODEL 1646T|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/09/2005|10/17/2005|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS AND MATERIAL FOR THE ISOFLEX S 1646T LEAD.
P030005|S020|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2005|10/12/2005|||OK30|CHANGE IN THE MANUFACTURING PROCESS SEQUENCE OF THE CONTAK RENEWAL TR VIRGIN HYBRIDS.
P960016|S014|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER ? SAFIRE MODEL|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/2005|02/24/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE HANDLE DESIGN, DEFLECTION MECHANISM, DEFLECTION CURVES, MATERIALS, MANUFACTURING PROCESSES, AND PACKAGING.
P980016|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 9996 AND MODEL 9997|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2005|11/15/2005|||APPR|APPROVAL FOR MEDTRONIC MODEL 9996 AND MODEL 9997 APPLICATION SOFTWARE VERSION 2.0 USED WITH INTRINSIC 30 MODEL 7287 AND INTRINSIC MODEL 7288 ICD SYSTEM.
P950020|S013|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|FLEXTOME CUTTING BALLOON MONORAIL(MR) AND OVER THE WIRE (OTW)|NWX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2005|09/29/2008|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT BOSTON SCIENTIFIC CORPORATION, IN MAPLE GROVE, MINNESOTA AND PLYMOUTH, MINNESOTA FOR THE MANUFACTURE OF THE BALLOON COMPONENT OF THE DEVICE.
P000037|S008|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2005|06/23/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE IN AUSTIN, TEXAS.
P030006|S007|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2005|10/06/2005|||OK30|CHANGE IN MANUFACTURING PROCESS TO REDUCE IN-PROCESS WASTE.
P990066|S022|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE DS & 2000D FFDM SYSTEM|MUE|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/2005|10/17/2005|||APPR|APPROVAL TO ADD LABELING ALERTING USER THAT IMAGES MAY BE DISPLAYED IN A MANNER DIFFERENT FROM THAT SPECIFIED IN MQSA REQUIREMENTS.
P010054|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS,ELECSYS PRECICONTROL  ANTI-HBS|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/2005|10/06/2005|||APPR|APPROVAL FOR CHANGE IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, OR OTHERWISE PROVIDE ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH, OR RELIABILITY OF THE ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS.
P010021|S007|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|Normal 180 Day Track||N|09/16/2005|01/12/2006|||APPR|APPROVAL OF THE REMOVAL OF THE WARNING ASSOCIATED WITH PRENATAL SCREENING AND A MODIFIED INDICATION FOR USE.  THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR WITH THE ADDITION OF MODEL DESIGNATIONS (ECIQ/ECI), AND IS INDICATED AS FOLLOWS:FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM.  THREE RECOMBINANT HEPATITIS C VIRUS ENCODED ANTIGENS ARE USED.  ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HEPATITIS C VIRUS, (STATE OR ASSOCIATED DISEASE NOT DETERMINED), IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION.  IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS C INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HCV DURING THE PRENATAL PERIOD.
P040016|S004|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/2005|12/16/2005|||APPR|APPROVAL FOR UPDATED LABELING THAT INCORPORATES THE RESULTS FROM THE ELECT STUDY.
P030031|S002|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2005|05/05/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.
P880086|S109|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Programmer, pacemaker|AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|KRG|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2005|10/14/2005|||OK30|ALTERNATE VENDOR OF QUADPOLAR FEEDTHROUGH ASSEMBLY FOR USE WITH AFFINITY, IDENTITY, INTEGRITY AND ENTITY FAMILY OF ICDS.
P910073|S056|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2005|10/17/2005|||OK30|ADDITIONAL SUPPLIER FOR THE TIP SEAL COMPONENT.
P040027|S002|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2005|12/08/2005|||APPR|APPROVAL TO CHANGE CERTAIN MANUFACTURING PROCESSES FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GORE VIATORR TIPS ENDOPROSTHESIS AND IS INDICATED FOR USE IN DE NOVO AND REVISION TREATMENT OF PORTAL HYPERTENSION AND ITS COMPLICATIONS SUCH AS VARICEAL BLEEDING, GASTROPATHY, ASCITES, AND/OR HEPATIC HYDROTHORAX.
P890003|S089|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC PACEMAKER SYSTEMS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2005|10/20/2005|||APPR|APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.
P900061|S057|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2005|10/20/2005|||APPR|APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.
P980016|S056|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2005|10/20/2005|||APPR|APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.
P980035|S047|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC PACEMAKER SYSTEMS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2005|10/20/2005|||APPR|APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.
P010031|S026|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEMS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2005|10/20/2005|||APPR|APPROVAL TO ACTIVATE THE CAPABILITY TO REMOTELY UPDATE THE SOFTWARE IN CARELINK MONITOR MODELS 2490A/D/E/G/H/J, THE MODEL 2030A BATTERYCHECK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER WITH THE SOFTWARE VERSIONS SPECIFIED IN ATTACHMENT A FOR USE WITH THE PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS AS SPECIFIED IN THE ATTACHMENT.
P910023|S083|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICES (ICD AND CRT-D)|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2005|10/17/2005|||OK30|ELIMINATION OF A REDUNDANT WELD OPERATION DURING THE ASSEMBLY OF THE HIGH VOLTAGE CAPACITOR FOR THE ICD/CRT-D DEVICES.
P030054|S012|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ICD/CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2005|10/17/2005|||OK30|ELIMINATION OF A REDUNDANT WELD OPERATION DURING THE ASSEMBLY OF THE HIGH VOLTAGE CAPACITOR FOR THE ICD/CRT-D DEVICES.
P010068|S007|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2005|10/21/2005|||APPR|APPROVAL FOR ALTERNATE STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, SAN DIEGO, CALIFORNIA, FOR THE INTERFACE CABLES (PART NUMBERS D-1195-XX) FOR ABLATION CATHETERS.
P010054|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/28/2005|03/13/2007|||APPR|APPROVAL FOR A CHANGE IN THE STANDARDIZATION PROCESS FOR THE ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS AND IS INDICATED: ELECSYS ANTI-HBS IMMUNOASSAY - FOR THE IN VITRO QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (EDTA). THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY ?ECLIA? IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZERS. ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAYBE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS ANDSYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.  ELECSYS PRECICONTROL ANTI-HBS - FOR THE QUALITY CONTROL OF THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS. THE PERFORMANCE OF ELECSYS PRECICONTROL ANTI-HBS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.
P040016|S005|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2005|11/18/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC IRELAND, LTD. (BSIL), GALWAY, IRELAND.
P020025|S014|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM|OAD|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|09/22/2005|12/23/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GROVE, ILLINOIS.
P920047|S030|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|09/22/2005|12/23/2005|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GROVE, ILLINOIS.
P970051|S034|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/23/2005|10/21/2005|||APPR|APPROVAL FOR AN ALTERNATIVE CABLE AND CONNECTOR (ALSO KNOWN AS SHOE) TO BE USED WITH THE PREVIOUSLY APPROVED NUCLEUS FREEDOM BODYWORN PROCESSOR.  THE ALTERNATIVE CABLE/SHOE HAS BEEN DESIGNED TO BE COMPATIBLE WITH WIRELESS FM COMMUNICATION SYSTEMS MANUFACTURED BY PHONAK HEARING SYSTEMS.
P790017|S084|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|NC STORMER OTW BALLOON DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2005|10/17/2005|||OK30|CHANGE WHICH WOULD INCREASE THE LENGTH OF THE DISTAL OUTER SHAFT OF NC STORMER OTW BALLOON DILATATION CATHETER FROM 21.5 CM - 23.5 CM TO 23.0 CM - 24.0 CM.
P030032|S004|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|HYLAFORM AND HYLAFORM PLUS|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/23/2005|11/02/2005|||APPR|APPROVAL FOR AN EXTENSION OF THE HYLAFORM AND HYLAFORM PLUS SHELF LIFE FROM 24 TO 36 MONTHS.
P990001|S020|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||implantable pacemaker Pulse-generator|VITATRON SOFTWARE MULTIPLE SOFTWARE MODELS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2005|11/22/2005|||APPR|APPROVAL FOR SOFTWARE REVISIONS.
P950037|S041|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||permanent pacemaker Electrode|CYLOS FAMILY OF PULSE GENERATORS|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2005|12/21/2005|||APPR|APPROVAL FOR THE CYLOS DR/DR-T AND CYLOS VR PULSE GENERATORS AND THE A-K00.6.U PROGRAMMER SOFTWARE (FOR USE WITH THE EPR 1000PLUS AND TMS 1000 PLUS PROGRAMMERS); THE 504.U PROGRAMMER SOFTWARE (FOR USE WITH THE ICS 3000 PROGRAMMER; AND THE HOME MONITORING SERVICE CENTER II VERSION 1.8.0.
P960040|S086|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY FAMILY OF AICDS AND PRIZM 1 FAMILY OF AICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2005|11/10/2005|||APPR|APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
P010012|S076|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 1|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2005|11/10/2005|||APPR|APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
P970043|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2005|10/14/2005|||APPR|APPROVAL FOR A SOFTWARE CALIBRATION "LOCK-OUT" FEATURE WHERBY THE LASER SYSTEM WILL BE "LOCKED-OUT" TO PREVENT THE INITIATION OF SURGERY MORE THAN 60 MINUTES AFTER THE LAST SYSTEM CALIBRATION, A "COUNTDOWN CLOCK" ON THE COMPUTER MONITOR WHICH WILL PROVIDE THE USER WITH FEEDBACK ON THE REMAINING TIME BEFORE THE SYSTEM WILL LOCK-OUT, AND A SOFTWARE BUG FIX TO CORRECT A CERTAIN "BUG" FROM OCCURRING UNDER CERTAIN CONDITIONS IF THE RULER TOOL WAS USED WITH THE TRACKER ENGAGED DURING SURGERY.
P860004|S076|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE DRUG PUMP|LKK|HO|Normal 180 Day Track No User Fee|Express GMP Supplement|N|09/27/2005|03/27/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO.
P880091|S019|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2005|10/19/2005|||OK30|REMOVAL OF THE CYTOTOXICITY TESTING ON POLYMER RAW MATERIALS BEFORE QC RELEASE TO MANUFACTURING.
P950022|S026|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|EPIC AND ATLAS FAMILIES OF DEVICES|LWS|CV|30-Day Notice||N|08/15/2005|09/13/2005|||OK30|REMOVAL OF A 14-DAY HOLD PERIOD BY INSTITUTING TOTAL AND DELTA BATTERY CURRENT TESTS.
P980040|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS FOLDABLE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AR40XEM|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2005|01/04/2007|||APPR|APPROVAL TO MARKET MODEL AR40XEM INTRAOCULAR LENS (IOL) UNDER THE TECNIS TRADE NAME AND FOR THE FOLLOWING LABELING CLAIMS: 1) IMPROVED MESOPIC CONTRAST SENSITIVITY; 2) IMPROVED MESOPIC LOW-CONTRAST ACUITY; AND 3) REDUCED SPHERICAL ABERRATION.
P040038|S001|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|09/29/2005|10/12/2005|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P860004|S077|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE DRUG INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2005|11/22/2005|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) CHANGE THE COMPOSITION OF THE MOTOR COIL PIN CONNECTOR MATERIAL FROM A PHOSPHOR BRONZE CONTAINING SOME LEAD TO A LEAD-FREE PHOSPHOR BRONZE; AND 2) MODIFY THE WELD COATING PROCESS FROM ONE LARGE MOUND OF SILICONE VARNISH OVER BOTH MOTOR COIL CONNECTOR PINS TO INDIVIDUAL MOUNDS OVER EACH PIN.
P810006|S022|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2005|09/20/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO FOR PACKAGING AND STERI-TECH, INC., SALINAS, PUERTO RICO FOR STERILIZATION.
P850010|S019|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2005|09/20/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO FOR PACKAGING AND STERI-TECH, INC., SALINAS, PUERTO RICO FOR STERILIZATION.
P970004|S033|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2005|06/30/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE INTERSTIM NEUROSTIMULATOR (MODEL 3058 INTERSTIM II), PATIENT PROGRAMMER (MODEL 3037 ICON), THERAPY APPLICATION SOFTWARE, TINED LEADS (MODELS 3889/3093), SYSTEM ACCESSORIES (MODEL 37092 EXTERNAL ANTENNA, TORQUE HEX WRENCH, TUNNELING TOOL), AND LABELING ARCHITECTURE.
P840062|S009|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING|LPG|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2005|09/20/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO FOR PACKAGING AND STERI-TECH, INC., SALINAS, PUERTO RICO FOR STERILIZATION.
P930038|S046|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/2005|10/05/2006|||APPR|APPROVAL TO REMOVE THE CURRENT PRECAUTION PERTAINING TO PATIENTS WITH PERIPHERAL VASCULAR DISEASE (PVD) FROM THE SPECIAL PATIENT POPULATIONS SECTION AND ADD A PRECAUTION TO TE PROCEDURE SECTION, IDENTIFYING PUBLISHED CLINICAL EXPERIENCE OF PATIENTS WITH PVD.
P030026|S008|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2005|10/21/2005|||APPR|APPROVAL FOR THE CHANGE THAT ADDRESSES THE ADDITION OF A CAUTION STATEMENT IN THE VITROS ANTI-HBC IGM REAGENT PACK INSTRUCTIONS FOR USE.
P040016|S006|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2005|10/28/2005|||OK30|MANUFACTURING PROCESS CHANGE TO THE DISTAL TIP WELD PROCESS AND INSPECTION CRITERIA OF THE LIBERTE CORONARY STENT SYSTEM.
P910023|S084|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS)|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2005|11/02/2005|||OK30|ALTERNATE MANUFACTURING PROCESS CHANGE TO ALLOW COMPONENT CURING IN AN AUTOCLAVE SYSTEM, WITH SUBSEQUENT REDUCTION IN PROCESS TIME.
P030054|S013|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2005|11/02/2005|||OK30|ALTERNATE MANUFACTURING PROCESS CHANGE TO ALLOW COMPONENT CURING IN AN AUTOCLAVE SYSTEM, WITH SUBSEQUENT REDUCTION IN PROCESS TIME.
P940031|S045|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY, MERIDIAN|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2005|12/21/2005|||APPR|APPROVAL FOR THE ADDITION OF INSPECTION TESTS, MATERIALS, ALTERNATE SUPPLIERS AND MANUFACTURING INSTRUCTIONS.
P960040|S087|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2005|12/21/2005|||APPR|APPROVAL FOR THE ADDITION OF INSPECTION TESTS, MATERIALS, ALTERNATE SUPPLIERS AND MANUFACTURING INSTRUCTIONS.
P010012|S077|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2005|12/21/2005|||APPR|APPROVAL FOR THE ADDITION OF INSPECTION TESTS, MATERIALS, ALTERNATE SUPPLIERS AND MANUFACTURING INSTRUCTIONS.
P030005|S021|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2005|12/21/2005|||APPR|APPROVAL FOR THE ADDITION OF INSPECTION TESTS, MATERIALS, ALTERNATE SUPPLIERS AND MANUFACTURING INSTRUCTIONS.
P980037|S015|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA THROMBECTOMY SYSTEM (XMI CATHETER)|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/03/2005|11/21/2006|||APPR|APPROVAL FOR MINOR CHANGES TO THE XMI CATHETER.
P980022|S013|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL TIME SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/2005|04/07/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE MMT 515/715 EXTERNAL INSULIN PUMP AND TO THE GUARDIAN RT SENSOR TO ENABLE THE PUMP TO ACCEPT DATA FROM THE SENSOR, AND TO ENABLE THE SENSOR TO COMMUNICATE DIRECTLY TO THE PUMP.  THE DEVICE WILL BE MANUFACTURED AT MEDTRONIC MINIMED, NORTHRIDGE, CALIFORNIA.
P010029|S002|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA|MOZ|OR|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2005|10/20/2005|||APPR|APPROVAL FOR CHANGING THE TRADE NAME O THE PRODUCT FROM NUFLEXXA TO EUFLEXXA.  THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
P900056|S086|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2005|11/05/2008|||APPR|APPROVAL FOR THE INCLUSION OF ADDITIONAL ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION IN THE ROTABLATOR CONSOLE DIRECTIONS FOR USE.
P890003|S091|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC PACEMAKER SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2005|11/15/2005|||APPR|APPROVAL FOR 1) MEDTRONIC MODEL 2490G CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DDMA SOFTWARE TO SUPPORT THE ENTRUST ICDS 2) TO MAKE OPTIVOL INFORMATION WITHOUT THE THRESHOLD LINE AVAILABLE FOR INSYNC SENTRY MODELS 7297 AND 7299 VIEWABLE BY PHYSICIANS USING THE CARELINK NETWORK.
P010015|S016|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041)|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/2005|03/07/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING TO DESCRIBE THE CARE-HF CLINICAL STUDY. MEDTRONIC ALSO REQUESTS A REFORMATTING OF THE INDICATIONS STATEMENT AND THE ADDITION OF A CLINICAL OUTCOMES SECTION TO THE DEVICE LABELING WHICH INCLUDES CLAIMS BASED ON THE PRIMARY ENDPOINT AND TWO SECONDARY ENDPOINTS IN THE CARE-HF STUDY. THE MEDTRONIC INSYNC III MODEL 8042 IS INDICATED FOR NYHA FUNCTIONAL CLASS III AND IV PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION. RATE ADAPTIVE PACING IS PROVIDED FOR THOSE PATIENTS DEVELOPING A BRADYCARDIA INDICATION WHO MIGHT BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY. DUAL CHAMBER AND ATRIAL TRACKING MODES ARE INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY.
P980016|S058|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR SYSTEMS ENTRUST ICOS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2005|11/15/2005|||APPR|APPROVAL FOR 1) MEDTRONIC MODEL 2490G CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DDMA SOFTWARE TO SUPPORT THE ENTRUST ICDS 2) TO MAKE OPTIVOL INFORMATION WITHOUT THE THRESHOLD LINE AVAILABLE FOR INSYNC SENTRY MODELS 7297 AND 7299 VIEWABLE BY PHYSICIANS USING THE CARELINK NETWORK.
P010031|S028|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2005|11/15/2005|||APPR|APPROVAL FOR 1) MEDTRONIC MODEL 2490G CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DDMA SOFTWARE TO SUPPORT THE ENTRUST ICDS 2) TO MAKE OPTIVOL INFORMATION WITHOUT THE THRESHOLD LINE AVAILABLE FOR INSYNC SENTRY MODELS 7297 AND 7299 VIEWABLE BY PHYSICIANS USING THE CARELINK NETWORK.
P030017|S010|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/13/2005|11/17/2005|||APPR|APPROVAL FOR THE DETACHABLE CHARGER POUCH, MODEL SC-6356.
P000029|S014|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX SYRINGE|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|10/28/2005|||OK30|ADDITION OF AN IN-PROCESS CONTROL TO REPLACE A TEST PROCEDURE FOR USAGE DURING ORDINARY MANUFACTURING.
P980035|S049|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700, VITATRON, KAPPA 900, ENPULSE, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|02/16/2006|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS.
P980016|S059|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR, MARQUIS VR, MAXIMO DR, MAXIMO VR, INTRINSIC 30, INTRINSIC, ENTRUST 30J/35J|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|02/16/2006|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS.
P890003|S092|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|THERA/PRODIGY|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|02/16/2006|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS.
P010031|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEM|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|02/16/2006|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS.
P970012|S018|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC KAPPA 400 SERIES PACEMAKER SYSTEMS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|02/16/2006|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS.
P970004|S034|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|02/21/2006|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANAYSIS.
P960009|S033|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ITREL 3, SOLETRA, DCI (SYNERGY)|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|02/16/2006|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS.
P840001|S083|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY VERSITREL, KINETRA|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2005|02/16/2006|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS.
P880086|S110|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/07/2005|01/31/2006|||APPR|APPROVAL FOR AN ALTERNATE ORGANIC FEEDTHRU SUBSTRATE TO BE USED IN THE AFFINITY, ENTITY, IDENTITY, IDENTITY ADX, INTEGRITY AND VERITY FAMILIES OF PULSE GENERATORS.
P890003|S093|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC PACEMAKER SYSTEMS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/07/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P910023|S085|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST JUDES MEDICAL ICD|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/11/2005|11/28/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE SEPTUM DESIGN OF ALL ST. JUDE MEDICAL ICDS(VR AND DR MODELS.)
P030054|S014|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST JUDES MEDICAL ICDS AND CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/11/2005|11/28/2005|||APPR|APPROVAL FOR MODIFICATIONS TO THE SEPTUM DESIGN OF ALL ST. JUDE MEDICAL ICDS AND CRT-DS.
P000029|S015|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2005|10/31/2005|||OK30|EQUIPMENT AND METHODS CHANGE IN TESTING THE POUCH SEAL STRENGTH FOR THE SUBJECT DEVICE.
P910077|S053|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX/MINI ICD SYSTEM|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2005|08/06/2007|||APPR|APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.
P010012|S078|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL CD|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2005|08/06/2007|||APPR|APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.
P030005|S022|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|RENEWAL TR|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2005|08/06/2007|||APPR|APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.
P960040|S088|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/ VITALITY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2005|08/06/2007|||APPR|APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.
P940031|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2005|08/06/2007|||APPR|APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.
P960043|S058|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR XL 8 & 10F PVS SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2005|03/31/2006|||APPR|APPROVAL FOR REVISED INSTRUCTIONS FOR USE.
P910077|S054|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RENEWAL 3 RF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/11/2005|12/02/2005|||APPR|APPROVAL FOR THE MODEL 6482 COMMUNICATOR LATITUDE WITH APPLICATION V1.6 AND SYSTEM APPLICATION SOFTWARE (SAS) WITH APPLICATION V1.1.1.
P020024|S006|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM|MAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/13/2005|02/06/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE END SCREW DESIGN.
P980016|S060|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO DR/ VR MODEL 7278 AND 7232 ICD SYSTEMS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2005|02/01/2006|||APPR|APPROVAL FOR THE MODEL 90001 EGMP5 DOWNLOAD APPLICATION USED MEDTRONIC MAXIMO DR/VR MODELS 7278 AND 7232 ICD SYSTEMS.
P840001|S084|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL3|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2005|01/30/2006|||APPR|APPROVAL FOR A FILTERED FEEDTHROUGH.
P970004|S035|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM-THERAPY FOR URINARY CONTROL|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2005|12/23/2005|||APPR|APPROVAL TO INCLUDE FILTERED FEEDTHROUGHS IN THE RIGHT HAND SHIELD ASSEMBLY.
P020025|S015|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EP TECH EPT-1000XP RF ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|10/13/2005|07/08/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, SUNNYVALE, CALIFORNIA.
P920047|S031|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EP TECH CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|10/13/2005|07/08/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, SUNNYVALE, CALIFORNIA.
P020045|S012|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2005|11/18/2005|||APPR|APPROVAL FOR CHANGES IN BOTH THE INCOMING AND FINAL QUALITY INSPECTIONS FROM THE CURRENT METHOD OF A RANDOM SAMPLING OF DEVICES TO EVALUATING 100% OF THE INCOMING SHAFTS COIL DIMENSIONS AND PERFORMING DEFLECTION TESTING ON 100% OF THE FINISHED SHAFTS.
P990012|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG TEST SYSTEM|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2005|11/09/2005|||APPR|APPROVAL FOR THE ADDITION OF INPROCESS TESTING.
P980037|S016|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET XMI AND XMI-RX CATHETERS|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/2005|07/11/2006|||APPR|APPROVAL FOR LABELING CHANGES TO THE IFU FOR THE ANGIOJET XMI AND ANGIOJET XMI-RX CATHETERS FOR USE IN THE CORONARY VASCULATURE.
P020018|S007|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|10/17/2005|03/23/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY SUBMISSION FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT.
P970004|S036|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2005|11/08/2005|||OK30|CHANGE IN TIME FOR THE STERILIZATION CYCLE.
P030025|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2005|11/10/2005|||OK30|CHANGE IN THE SUPPLIER AND MODEL NUMBER OF THE INCUBATOR/SHAKER APPARATUS THAT IS USED IN THE DRUG ASSAY OF THE DEVICE.
P010038|S010|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECOND LOOK|MYN|RA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|10/18/2005|01/13/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INFUMEDICS, INC., EAST WALPOLE, MASSACHUSETTS.
N16895|S089|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFTLENS (POLYMACON) CONTACT LENS|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2005|05/17/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAUSCH & LOMB, PORTO ALEGRE, BRAZIL.
P890003|S095|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/19/2005|11/22/2005|||APPR|APPROVAL FOR A SOFTWARE UPDATE, SOFTWARE SERIES 5.0 TO SOFTWARE SERIES 6.0, TO CORRECT A MINOR CUSTOMER INCONVENIENCE ANOMALY WITH TELEMETRY ERROR CONDITIONS RELATED TO THE RETRY STRATEGY BY ADDITION OF AN ENHANCEMENT CHECK TO ENSURE THAT ALL OF THE EVENT DATA HAS BEEN RECEIVED.
P000008|S009|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/2005|04/24/2006|||APPR|APPROVAL FOR AN EXTENSION TO THE LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) PRODUCT LINE TO INCLUDE THE LARGE AND SMALL LAP-BAND ADVANCED PLATFORM (AP) DESIGN.
P010012|S079|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL 3 RF CRT-D, MODELS H210, H215, H217 AND H219|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2005|11/23/2005|||OK30|CHANGE FOR THE REMOVAL OF ZOOM E3 TEST FROM THE BUILD PROCESS.
P910073|S057|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE ACTIVE FIX, & PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2005|11/22/2005|||OK30|ADDITION OF SIGHT HOLES TO THE TERMINAL PINS, WITH INCREASE IN INSERTION CAVITY FOR THE PASSIVE FIX VERSION, RESULTING IN AN ADDITIONAL INSPECTION STEP.
P010025|S008|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/2005|03/29/2006|||APPR|APPROVAL FOR AN OPTIONAL PRODUCT CONFIGURATION OF TUNGSTEN TARGET WITH RHODIUM AND SILVER FILTERS IN THE X-RAY SYSTEM INSTEAD OF MOLYBDENUM TARGET WITH MOLYBDENUM AND RHODIUM FILTERS.
P960013|S014|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|SDX PERMANENT PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2005|06/08/2006|||APPR|APPROVAL FOR THE REDUCTION IN THE HUMIDITY OVEN CURE-TIME FOR SJM LEADS.
P980031|S009|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS PRESCRIPTION INSERTS|LQE|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2005|11/23/2005|||OK30|TRANSFER OF NON-CRITICAL "AS/MANUFACTURED" DIMENSIONAL INSPECTIONS OF WIDTH, SYMMETRY, OUTER DIAMETER, ARC LENGTH, AND DRILL HOLE PLACEMENT FOR MACHINED INTACS PRESCRIPTION INSERTS FROM BIOTEST LABORATORIES TO OCULAR TECHNOLOGY INC.
P030054|S015|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|AFFINITY/INTEGRITY, PHOTON, ATLAS, EPIC & PSA FAMILIES OF DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2005|11/15/2005|||APPR|APPROVAL FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM  WITH THE MODEL 3330 VERSION 1.1 SOFTWARE, MODEL 3616 WAND EXTENSION CABLE, AND MODEL 3617 ECG INPUT CABLE.
P030008|S004|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/24/2005|04/19/2006|06M-0199|05/12/2006|APPR|APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM.  THE DEVICE USED OPTICAL ZONES OF 6.0-7.0 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 DIOPTERS (D) AT THE SPECTACLE PLANE; 2) PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P030002|S006|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS|NAA|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2005|03/03/2006|||APPR|APPROVAL FOR UPDATED PHYSICIAN LABELING WITH 3-YEAR CLINICAL DATA.
P000044|S009|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2005|11/17/2005|||OK30|ADDITION OF AN ALTERNATIVE SUPPLIER FOR ANTI-HBS ANTIBODY USED IN THE MANUFACTURE OF THE VITROS HBSAG REAGENT PACK AND CALIBRATORS.
P980035|S050|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|IMPLANTABLE PULSE GENERATOR, MODEL AT501|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2005|03/02/2006|||APPR|APPROVAL FOR CHANGES TO THE SRAM.
P910073|S058|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2005|11/23/2005|||OK30|CHANGE OF SILICONE ADHESIVE.
P030010|S003|SIEMENS MEDICAL SOLUTION|51 VALLEY STREAM PKWY.||MALVERN|PA|19355||Full field digital,system,x-ray,mammographic|SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/26/2005|02/15/2006|||APPR|APPROVAL FOR USE OF THE SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (MAMMOMAT NOVATIONDR) IN A MOBILE ENVIRONMENT.
P910023|S086|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST. JUDE MEDICAL ICDS/CRT-DS|NVZ|CV|135 Review Track For 30-Day Notice||N|10/26/2005|04/20/2006|||APPR|APPROVAL FOR A CHANGE IN THE EPOXY USED DURING THE MANUFACTURING PROCESS.
P030054|S016|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ICDS/CRT-DS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2005|04/20/2006|||APPR|APPROVAL FOR A CHANGE IN THE EPOXY USED DURING THE MANUFACTURING PROCESS.
P960058|S047|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/2005|04/11/2006|||APPR|APPROVAL FOR A REVISION TO THE AURIA BEHIND-THE-EAR SOUND PROCESSOR, WHICH WILL BE MARKETED UNDER THE TRADE NAME AURIA HARMONY.  THE REVISION INCORPORATES NEW CIRCUITRY, FIRMWARE, AND COMPONENTS, INCLUDING A NEW DIGITAL SIGNAL PROCESSOR CHIP, INTERNAL TELECOIL, BUILT-IN DIAGNOSTIC LIGHT EMITTING DIODE (LED), IMPROVED AUDIO FRONT END, AND ENHANCED FRF TRANSMITTER.
P830055|S092|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM - PFC SIGMA RPF KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2005|11/17/2005|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS TO THE FEMORAL COMPONENTS OF THE ABOVE REFERENCED COMPONENTS.  THESE MODIFICATIONS ADD A REQUIREMENT FOR LINE CLEARANCE AND A STEP FOR COLOR CODE STICKER VERIFICATION BY A SECOND OPERATOR TO MANUFACTURING PROCESS SPECIFICATION (MPS) - 1699.  THE 2ND OPERATOR COLOR CODE STICKER VERIFICATION STEP IS ALSO BEING ADDED TO THE TRAVELERS FOR THE AFFECTED PRODUCT.
P010014|S003|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2005|04/20/2007|||APPR|APPROVAL FOR A CHANGE TO TICONA GUR 1050 UHMWPE FROM MONTEL/BASELL 1900H UHMWPE.
P950020|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS|NWX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2005|09/29/2008|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT BOSTON SCIENTIFIC CORPORATION, IN MAPLE GROVE, MINNESOTA AND PLYMOUTH, MINNESOTA FOR THE MANUFACTURE OF THE BLADE (ATHEROTOMES) AND MOUNTED BALLOON/BLADE SUBASSEMBLY FOR THE DEVICE.
P000039|S011|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM|MAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2005|05/12/2006|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE PIGMENT TO BE USED DURING MANUFACTURE OF THE PTFE TUBING COMPONENTS OF THE AMPLATZER DELIVERY AND EXCHANGE SYSTEM SHEATHS, DILATORS AND LOADERS.
P020024|S007|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM|MAE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2005|05/12/2006|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE PIGMENT TO BE USED DURING MANUFACTURE OF THE PTFE TUBING COMPONENTS OF THE AMPLATZER DELIVERY AND EXCHANGE SYSTEM SHEATHS, DILATORS AND LOADERS.
P910077|S055|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GUIDANT ZOOM PROGRAMMER|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2005|12/20/2005|||APPR|APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 MAINTENANCE RELEASE SOFTWARE (SW) VERSION 1.5.
P010003|S007|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/2005|12/08/2005|||APPR|APPROVAL FOR A 10 ML SYRINGE VOLUME; A SOFTER POLYMER IN THE PISTON OF THE SYRINGE; AN ALTERNATE SUPPLIER FOR THE POLYETHYLENE FOR THE CAP PLUG OF THE ENTIRE DELIVERY SYSTEM PRODUCT LINE; AND ADDITION OF A 10 PACK OF POUCHED (4/POUCH) STANDARD SYRING TIPS.
P010014|S004|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2005|03/31/2006|||APPR|
P010014|S005|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Normal 180 Day Track No User Fee|Express GMP Supplement|N|11/01/2005|08/03/2007|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON PLC, BERKSHIRE, UNITED KINGDOM.
P020024|S008|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER AND AMPLATZER 180 DEGREE DELIVERY AND EXCHANGE SYSTEM|MAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2005|02/06/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE END SCREW DESIGN.
P840001|S086|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2005|11/30/2005|||OK30|CHANGE IN THE ETHYLENE OXIDE EXPOSURE TIME.
P960009|S034|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|IMPLANTABLE NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2005|11/30/2005|||OK30|CHANGE IN THE ETHYLENE OXIDE EXPOSURE TIME.
P010014|S006|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2005|08/30/2007|||APPR|APPROVAL FOR THE FOLLOWING CHANGES IN THE MANUFACTURING PROCESSES FOR THE TIBIAL, MENISCAL BEARING, AND FEMORAL COMPONENTS FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEED SYSTEM: 1) ADDITION OF INSPECTION CHECKS; AND 2) ADDITION OF PREWASHES.
P020024|S009|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2005|11/30/2005|||OK30|ADDITION OF A NITINOL WIRE BRAIN HEAT TREATMENT STEP TO THE MANUFACTURING PROCESS.
P910023|S087|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PHOTON, EPIC, AND ATLAS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND CARDIAC RESYNCHRONIZATION THERAPY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2005|11/18/2005|||OK30|CHANGE FROM MANUAL EPOXY DISPENSING METHOD TO AN AUTOMATED ROBOT CONTROLLED EPOXY DISPENSING SYSTEM.
P030054|S017|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PHOTON, EPIC, AND ATLAS FAMILIES OF ICDS AND CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2005|11/18/2005|||OK30|CHANGE FROM MANUAL EPOXY DISPENSING METHOD TO AN AUTOMATED ROBOT CONTROLLED EPOXY DISPENSING SYSTEM.
P970043|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/03/2005|05/02/2006|06M-0324|08/17/2006|APPR|APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM.  THESE DEVICES USE A 6.5 MM OPTICAL ZONE AND A 9.0 TREATMENT ZONE AND ARE INDICATED FOR WAVE-FRONT GUIDED CUSTOMCORNEA LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MIXED ASTIGMATISM 1.00 D TO LESS THAN 5.00 D CYCLOPLEGIC CYLINDER MAGNITUDE AT THE SPECTACLE PLANE, WHICH IS GREATER THAN THE SPHERE MAGNITUDE, AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE IN SPHERE AND CYLINDER OF LESS THAN OR EQUAL TO 0.50 D.
P040043|S007|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2005|11/30/2005|||OK30|ELIMINATION OF A REDUNDANT STENT WIRE CLEANING STEP.
P030005|S023|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2005|11/30/2005|||OK30|TRANSFER OF THE ASSEMBLY AND TESTING FUNCTIONS OF THE FILTERED FEEDTHROUGH MANUFACTURING PROCESS TO A SECOND SUPPLIER LOCATION.
P960009|S035|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA DEEP BRAIN STIMULATION SYSTEMS|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/2005|12/06/2005|||APPR|APPROVAL FOR RECOMMENDING MAXIMUM DISPLAYED HEAD SAR TO BE 0.1 W/KG WITH RESPECT TO THE MRI (MAGNETIC RESONANCE IMAGING) INSTRUCTIONS.
P020004|S014|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2005|11/30/2005|||OK30|ELIMINATION OF A REDUNDANT STENT WIRE CLEANING STEP.
P970003|S062|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2005|12/28/2005|||APPR|APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE - VERSION 7.2 FOR USE WITH MODEL 100 VERSIONS B AND C, MODEL 101 VERSIONS 1 AND 2, AND MODELS 102 AND 102R PULSE GENERATORS.
P960058|S048|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2005|12/05/2005|||OK30|
P030017|S011|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2005|12/09/2005|||APPR|APPROVAL FOR THE PASSING ELEVATOR.
P890003|S096|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC PACEMAKER SYSTEMS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2005|02/15/2006|||APPR|APPROVAL FOR THE ALTERNATE HARD DISK DRIVE FOR MEDTRONIC CARELINK PROGRAMMER MODEL 2090.
P030054|S018|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/2005|02/15/2006|||APPR|APPROVAL FOR A MODIFICATION TO THE QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD TO INCREASE THE PEAK-TO-PEAK AMPLITUDE OF THEN DISTAL S-CURVE HEIGHT TO 16 MM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD AND IS INDICATED FOR APPLICATION AS PART OF A ST. JUDE MEDICAL BIVENTRICULAR SYSTEM.
P040014|S002|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|IBI THERAPY ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2005|12/08/2005|||OK30|CHANGE TO THE TUBE FUSING PROCESS AND A CHANGE IN THE ADHESIVE USED IN THE WELD JOINT PROCESS.
P910073|S059|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE LEADS FLUORO RING|LWS|CV|30-Day Notice||N|11/09/2005|12/08/2005|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE FLUORO RING COMPONENT USED FOR IDENTIFYING THE POSITION OF THE ELECTRODE DURING FLUOROSCOPY.
P960006|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND FAMILY OF LEADS|NVY|CV|30-Day Notice||N|11/09/2005|12/08/2005|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE FLUORO RING COMPONENT USED FOR IDENTIFYING THE POSITION OF THE ELECTRODE DURING FLUOROSCOPY.
P910023|S088|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/2005|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P030054|S019|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/2005|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P040002|S002|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2005|02/08/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE IN IRVINE, CALIFORNIA.
P950037|S042|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60)|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/2005|02/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE SELOX SR PACING LEAD FAMILY TO CHANGE THE STEROID DOSAGE, MAXIMUM LEAD BODY DIAMETER, AND RING ELECTRODE BASE MATERIAL, AS WELL AS OTHER MINOR CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD AND IS INDICATED FOR PERMANENT PACING AND SENSING.
P040023|S002|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM|MRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2005|12/12/2005|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS TO VARIOUS COMPONENTS OF THIS SYSTEM.  THESE CHANGES INCLUDE MODIFICATION TO SEVERAL MANUFACTURING PROCESS SPECIFICATIONS (MPS) FOR GAMMA VACUUM FOIL (GVF) PACKAGED PRODUCTS: 1) TO ADD PHYSICAL SEPARATION BARRIERS TO THE SEALING MACHINE TO PREVENT ADJACENT FOIL POUCHES FROM OVERLAPPING DURING THE SEALING OPERATION, AND 2) TO REQUIRE A SECOND 100% INSPECTION OF THE SEAL INTEGRITY OF EACH PACKAGE PRIOR TO SHIPMENT.
P910016|S015|DEPUY, INC.|700 ORTHOPAEDIC DR.||WARSAW|IN|46581|0988|PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER|LCS UNI KNEE SYSTEM|MBD|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2005|12/12/2005|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS TO THE LCS PRESERVATION UNI MOBILE BEARING INSERTS APPROVED IN P910016/S012.  THE CHANGES INCLUDE MODIFICATIONS TO SEVERAL MANUFACTURING PROCESS SPECIFICATIONS (MPS) FOR GAMMA VACUUM FOIL (GVF) PACKAGED PRODUCTS: 1) TO ADD PHYSICAL SEPARATION BARRIERS TO THE SEALING MACHINE TO PREVENT ADJACENT FOIL POUCHES FROM OVERLAPPING DURING THE SEALING OPERATION, AND 2) TO REQUIRE A SECOND 100% INSPECTION OF THE SEAL INTEGRITY OF EACH PACKAGE PRIOR TO SHIPMENT.
P830055|S093|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2005|12/12/2005|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS TO VARIOUS COMPONENTS OF THE LCS TOTAL KNEE SYSTEM.  THE CHANGES INCLUDE MODIFICATIONS TO SEVERAL MANUFACTURING PROCESS SPECIFICATIONS (MPS) FOR GAMMA VACUUM FOIL (GVF) PACKAGED PRODUCTS: 1) TO ADD PHYSICAL SEPARATION BARRIERS TO THE SEALING MACHINE TO PREVENT ADJACENT FOIL POUCHES FROM OVERLAPPING DURING THE SEALING OPERATION, AND 2) TO REQUIRE A SECOND 100% INSPECTION OF THE SEAL INTEGRITY OF EACH PACKAGE PRIOR TO SHIPMENT.
P930014|S016|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2005|12/16/2005|||APPR|APPROVAL FOR IOL MODELS SN60T3, SN60T4 AND SN60T5.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF TORIC SINGLE-PIECE NATURAL IOL AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE IMPROVED SPECTACLE INDEPENDENCE FOR DISTANCE VISION.
P860057|S031|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|12/06/2005|||APPR|APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.
P000039|S012|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND AMPLATZER TORQVUE DELIVERY AND EXCHANGE SYSTEM|MAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2005|04/25/2007|||APPR|APPROVAL FOR A NEW DELIVERY SYSTEM AND MODIFICATIONS TO THE DEVICE PACKAGING.  THE DEVICES, WITH THE MODIFIED DELIVERY SYSTEMS, WILL BE MARKETED UNDER THE TRADE NAME TORQVUE DELIVERY AND EXCHANGE SYSTEMS.
P870056|S023|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS,MODELS 2625 & 6625|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|12/06/2005|||APPR|APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.
P870077|S021|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|12/06/2005|||APPR|APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.
P000007|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|12/06/2005|||APPR|APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.
P020024|S010|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2005|04/25/2007|||APPR|APPROVAL FOR A NEW DELIVERY SYSTEM AND MODIFICATIONS TO THE DEVICE PACKAGING.  THE DEVICES, WITH THE MODIFIED DELIVERY SYSTEMS, WILL BE MARKETED UNDER THE TRADE NAME TORQVUE DELIVERY AND EXCHANGE SYSTEMS.
P010041|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V) BIOPROSTHESIS,MODEL 2650|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|12/06/2005|||APPR|APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES.
P890019|S012|DIASORIN|1951 NORTHWESTERN AVENUE|PO BOX 285|STILLWATER|MN|55082|0285|Hepatitis a test (antibody and igm antibody)|ETI-AB-HAVK PLUS|LOL|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|12/12/2005|||APPR|APPROVAL FOR CHANGE IN THE MANUFACTURING PROCESS FOR THE NEUTRALIZING SOLUTION (HAV REAGENT).
P880086|S111|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY ADX FAMILY OF PACEMAKERS SYNCHRONCY DEVICE|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|02/08/2006|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO.
P910023|S089|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|TACHYCARDIA DEFIBRILLATOR DEVICES|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|02/08/2006|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO.
P830045|S092|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PROGRAMMER TO SUPPORT VARIOUS PACEMAKERS & DEFIBRILLATORS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|02/08/2006|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO.
P030026|S009|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODICTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|12/08/2005|||OK30|CHANGE IN THE MANUFACTURING EQUIPMENT TO PACK COATED WELLS.
P030024|S004|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2005|12/08/2005|||OK30|CHANGE IN THE MANUFACTURING EQUIPMENT TO PACK COATED WELLS.
P010021|S008|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2005|12/08/2005|||OK30|CHANGE IN THE MANUFACTURING EQUIPMENT TO PACK COATED WELLS.
P880086|S112|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IMPLANTABLE PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2005|05/02/2006|||APPR|APPROVAL FOR A TEST BEING ADDED TO THE IC WAFER PROBE TEST SUITE.
P940031|S047|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2005|12/19/2005|||OK30|ADDITION OF AN AUTOMATED INSPECTION VISION SYSTEM.
P010012|S080|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2005|12/19/2005|||OK30|ADDITION OF AN AUTOMATED INSPECTION VISION SYSTEM.
P960040|S089|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2005|12/19/2005|||OK30|ADDITION OF AN AUTOMATED INSPECTION VISION SYSTEM.
P030005|S024|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2005|12/19/2005|||OK30|ADDITION OF AN AUTOMATED INSPECTION VISION SYSTEM.
P040034|S002|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2005|12/13/2005|||APPR|APPROVAL FOR CHANGING THE PACKAGE CONFIGURATIONS TO INCLUDE A 1 UNIT CONFIGURATION, IDENTIFIED AS "1-UP".
P940040|S006|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST|MWA|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2005|12/14/2005|||OK30|CHANGE TO THE PURIFICATION PROCESS.
P000041|S003|RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL|MYN|RA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|11/18/2005|07/27/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT RIVERAIN MEDICAL GROUP, MIAMISBURG, OHIO.
P000044|S010|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2005|12/08/2005|||OK30|CHANGE IN THE MANUFACTURING EQUIPMENT TO PACK COATED WELLS.
P030044|S001|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, epidermal growth factor receptor|DAKOCYTOMATION EGFR PHARMDX KIT|NQF|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/17/2005|02/01/2006|||APPR|APPROVAL FOR ADDITIONAL LABELING CHANGES INCLUDE A CLARIFICATION IN THE DEFINITION OF POSITIVE STAINING FOR INDIVIDUAL TUMOR CELLS, INCLUSION OF LIMITATION ABOUT CETUXIMAB RESPONSE RATE FOR NEGATIVE/ POSITIVE PATIENTS AND PERFORMANCE INDICES FOR PATIENTS WHO HAD <1% POSITIVE TUMOR CELLS FOR EGFR.
P960040|S090|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|GUIDANT VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2005|12/15/2005|||OK30|CHANGE THE APPLICATION OF MEDICAL ADHESIVE ONTO THE DEVICE HEADER FROM A MANUAL TO AN AUTOMATED PROCESS.
P970043|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADAR 6000 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/2005|05/01/2006|||APPR|APPROVAL TO INCREASE THE PULSE REPETITION RATE OF THE LADAR 6000 EXCIMER LASER FROM 60 HZ TO 92 HX.
P030006|S008|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/2005|03/31/2006|||APPR|APPROVAL FOR SOFTWARE REVISIONS AND MODIFICATION OF THE DEVICE OPERATING SYSTEM TO EMBEDDED WINDOWS XP.
P950034|S028|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice||N|11/18/2005|12/05/2005|||OK30|CHANGE IN PERFORMANCE SPECIFICATIONS TO ELIMINATE ETHANOL AND ISOPROPYL ALCOHOL TESTING FROM SEPRAFILM QUALITY CONTROL RELEASE CRITERIA.
P970008|S030|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2005|03/20/2006|||APPR|APPROVAL FOR UPGRADES TO THE TARGIS SYSTEM.  THESE CHANGES INCLUDE IMPROVED APPEARANCE (WHICH REQUIRED REPLACING THE CONTROL UNIT EXTERIOR PANELS AND MOVING THE USER CONTROLS), IMPROVED ELECTROMAGNETIC COMPATIBILITY (EMC), AND OTHER COMPONENT AND MANUFACTURING MODIFICATIONS DUE TO COMPONENT OBSOLESCENCE.
P000014|S013|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2005|12/08/2005|||OK30|CHANGE IN THE MANUFACTURING EQUIPMENT TO PACK COATED WELLS.
P040016|S007|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2005|12/21/2005|||OK30|ADDITION OF ANOTHER STAINLESS STEEL TUBING RAW MATERIAL SUPPLIER.
P000039|S013|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER ? ?CRIBRIFORM? OCCLUDER|MAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2005|09/21/2006|||APPR|APPROVAL FOR THE AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER (?CRIBRIFORM? OCCLUDER).  THE DEVICE IS INDICATED FOR THE CLOSURE OF MULTI-FENESTRATED (CRIBRIFORM) ATRIAL SEPTAL DEFECTS.
P040023|S003|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC-ON-CERAMIC HIP SYSTEM|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/2005|12/22/2005|||APPR|APPROVAL FOR CHANGES TO THE LABELING THAT INCLUDE: 1) THE ADDITION OF AN INTRAOPERATIVE PRECAUTION ADVISING THE SURGEON OF THE NECESSITY FOR CORRECT POSITIONING OF THE INSERT COMPONENT PRIOR TO ASSEMBLING IT TO THE METAL OUTER SHELL AND EXAMINING THE CERAMIC LINER FOLLOWING FINAL ASSEMBLY, AND 2) UPDATING THE ADVERSE EVENT TABLE TO REFLECT THE HIGHER RATE OF INTRAOPERATIVE CHIPPING EXPERIENCED IN THE FIRST SIX MONTHS OF U.S. DISTRIBUTION.
P010031|S031|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CONCERTO MODEL C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CONCERTO VIRTUOSO V1.0 SOFTWARE APPLICATION|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2005|05/12/2006|||APPR|APPROVAL FOR CONCERTO MODEL C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CONCERTO-VIRTUOSO V1.0 SOFTWARE APPLICATION MODEL SW002.  THE CONCERTO MODEL C154DWK IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION.
P910077|S056|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2005|05/01/2006|||APPR|APPROVAL FOR AN UPDATE THE VISUAL INSPECTION CRITERIA IN GMAI (GENERAL MANUFACTURING AREA INSTRUCTION) I00093.
P010012|S081|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTACK RENEWAL IS1/DR1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2005|05/01/2006|||APPR|APPROVAL FOR AN UPDATE THE VISUAL INSPECTION CRITERIA IN GMAI (GENERAL MANUFACTURING AREA INSTRUCTION) I00093.
P030006|S009|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2005|03/15/2006|||APPR|APPROVAL FOR MULTIPLE DESIGN MODIFICATIONS WHICH AFFECT THE SAFETY AND EFFECTIVENESS OF THE PROLIEVE DEVICE.
P950020|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS|NWX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2005|09/29/2008|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT BOSTON SCIENTIFIC CORPORATION, IN MAPLE GROVE, MINNESOTA AND PLYMOUTH, MINNESOTA FOR THE ULTRA2 BALLOON SUBASSEMBLY MANUFACTURING PROCESSES.
P960040|S091|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM VR, PRIZM DR, PRIZM HE VR, PRIZM HE DR, PRIZM 2 VE, PRIZM 2 DR, PRIZM AT ICDS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2005|05/01/2006|||APPR|APPROVAL FOR AN UPDATE THE VISUAL INSPECTION CRITERIA IN GMAI (GENERAL MANUFACTURING AREA INSTRUCTION) I00093.
P040042|S001|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|IBI THERAPY DUAL 8 ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2005|12/21/2005|||OK30|CHANGE IN THE TUBE FUSING PROCESS AND A CHANGE IN THE ADHESIVE.
P840039|S055|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|ULTRAVIOLET (UV) ABSORBING AND NON-UV ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/22/2005|04/24/2006|||APPR|APPROVAL FOR A CHANGE IN THE LENS CARRIER TO A ROTARY CAP CARRIER.
P980016|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE CONCERTO - VIRTUOSO V 1.0 SOFTWARE APPLICATION MODEL SW002.  THE MEDTRONIC VIRTUOSO DR MODEL D154AWG DEVICE IS INDICATED AS FOLLOWS:  THE DEVICE IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS IN PATIENTS WITH NYHA FUNCTIONAL CLASS II/III HEART FAILURE.  IN ADDITION, THE DEVICE IS INDICATED FOR USE IN THE ABOVE PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION.  NOTES: 1) THE ICD FEATURES OF THE VIRTUOSO DEVICE FUNCTION THE SAME AS OTHER APPROVED MEDTRONIC MARKET-RELEASED ICDS.  2) DUE TO THE ADDITION OF THE OPTIVOL DIAGNOSTIC FEATURE, THE VIRTUOSO INDICATION IS LIMITED TO NYHA FUNCTIONAL CLASS II/III HEART FAILURE PATIENTS WHO ARE INDICATED FOR AN ICD.  3) THE CLINICAL VALUE OF THE OPTIVOL FLUID MONITORING DIAGNOSTIC FEATURE HAS NOT BEEN ASSESSED IN THOSE PATIENTS WHO DO NOT HAVE FLUID RETENTION RELATED SYMPTOMS DUE TO HEART FAILURE. 4) THE USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS.  5) THE EFFECTIVENESS OF HIGH-FREQUENCY BURST PACING (ATRIAL 50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.8%, IN THE VT/AT PATIENT POPULATION STUDIED.  (CONT...)
P860004|S078|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED IMPLANTABLE INFUSION SYSTEM: PERCUTANEOUS INTRASPINAL CATHETER KIT|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|11/23/2005|03/10/2006|||APPR|APPROVAL FOR INCLUSION OF THE B. BRAUN MEDICAL PERIFIX CATHETER CONNECTOR IN THE MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT.
P970053|S009|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/23/2005|10/11/2006|06M-0460|11/14/2006|APPR|APPROVAL FOR THE NIDEK EC-5000 EXCIMER LASER SYSTEM.  THE DEVICE USES A 6.0 MM OPTICAL ZONE AND A 9.0 MM TREATMENT ZONE AND IS INDICATED FOR LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK):  1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA REFRACTIVE ERRORS FROM +0.5 TO +5.0 D OF SPHERE WITH OR WITHOUT ASTIGMATIC REFRACTIVE ERRORS FROM +0.5 TO +2.0 D AT THE SPECTACLE PLANE WITH MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +5.0 D OR LESS;  2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND  3) IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN +/- 0.50 DIOPTER.
P910073|S060|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2005|12/15/2005|||OK30|RETROACTIVE CHANGES MADE TO THE IS-1 (INTERNATIONAL STANDARD LEAD CONNECTOR), DF-1 (DEFIBRILLATOR CONNECTOR) TERMINAL CRIMP, AND DF-1 DISTAL FITTING STAKE FOR ENDOTAK RELIANCE FAMILY OF LEADS.
P010033|S009|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON -TB GOLD|NCD|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2005|07/26/2006|||APPR|APPROVAL FOR A CONTRACT MANUFACTURING SITE LOCATED AT SCANTIBODIES LABORATORY, INC., SANTEE, CALIFORNIA.
P020014|S010|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/23/2005|10/11/2006|||APPR|APPROVAL FOR MODIFICATION OF THE ESSURE PHYSICIAN AND PATIENT LABELING TO INCLUDE INFORMATION ON THE RESULTS OF THE POSTAPPROVAL STUDY FOR NEWLY TRAINED PHYSICIANS.
P020035|S002|St. Jude Medical, Inc.|6500 WEDGWOOD RD.||MAPLE GROVE|MN|55311||Device, hemostasis, vascular|X-SITE SUTURE-MEDIATED CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/2005|03/03/2006|||APPR|APPROVAL FOR VARIOUS LABELING CHANGES AND ERGONOMIC CHANGES TO THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME X-SITE SUTURE-MEDIATED CLOSURE DEVICE AND IS INDICATED FOR ??THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FR.  THE X-SITE SUTURE-MEDIATED CLOSURE DEVICE IS INTENDED TO REDUCE THE TIME TO H0MOSTASIS, TIME TO AMBULATION (100 FEET), AND TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS, INCLUDING THOSE RECEIVING GLYCOPROTEIN IIB/IIIA INHIBITORS.?
P010032|S018|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/25/2005|12/21/2005|||APPR|APPROVAL FOR THE 90 CM AND 110 CM LENGTH VERSIONS OF THE ANS 3100 AND 3200 SERIES LEADS, WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P980037|S017|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-SPIROFLEX CATHETER|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2005|01/25/2007|||APPR|APPROVAL FOR CHANGES TO THE XMI-RX CATHETER RESULTING IN A NEW CATHETER CALLED SPIROFLEX.
P030009|S004|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER CORONARY STENT SYSTEM FAMILY OF PRODUCTS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2005|12/22/2005|||OK30|CHANGE IN AN APPROVED SUPPLIER'S PROCESSING STEPS TO ALLOW THEM TO FURTHER PROCESS A SUBASSEMBLY IN ACCORDANCE WITH YOUR OWN MANUFACTURING OPERATIONS AND DEVICE SPECIFICATIONS.
P970058|S022|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY|MYN|RA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2005|06/23/2006|||APPR|APPROVAL OF NEW LABELING THAT WILL PRESENT THE SPECIFICITY OF CAD MARKS GENERATED BY R2 IMAGECHECKER COMPUTER AIDED DETECTION SYSTEM AS WELL AS ITS ABILITY TO MARK ACTIONABLE PRIORS.  THE INDICATIONS FOR USE REMAIN AS PREVIOUSLY APPROVED:  THE IMAGECHECKER M5000 IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
P840001|S088|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC NEUROSTIMULATION SYSTEMS (RESTORE, SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+)|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/2005|01/26/2006|||APPR|APPROVAL FOR A MODIFICATION OF THE MODEL 37742 PATIENT PROGRAMMER TO ALLOW PATIENTS TO RESET A POWER-ON-RESET (POR) STATUS OF THE EXTERNAL NEUROSTIMULATOR TO THE PHYSICIAN PROGRAMMED SETTINGS.
P030006|S010|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2005|01/20/2006|||APPR|APPROVAL FOR A NEW SANMINA-SCI CORPORATION MANUFACTURING SITE LOCATED IN HUNTSVILLE, ALABAMA TO MANUFACTURE THE PROLIEVE THERMODILATATION SYSTEM CONSOLE AND RECTAL TEMPERATURE MONITOR.
P990052|S012|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM|MPV|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2005|10/13/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MED-EL ELEKTROMEDIZINISCHE GERATE (CONTRACT MANUFACTURER FOR VIBRANT MED-EL) GMBH OF INNSBRUCK, AUSTRIA, FOR THE LASER WELDING OF THE PRE WELDED DEMODULATOR UNIT AND THE BOBBIN.
P910073|S061|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE G/SG LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2005|12/30/2005|||OK30|CHANGE IN MANUFACTURING PROCESS THAT IMPROVES THE DISTAL COIL BONDING PROCESS BY 1) CHANGING THE CONSTITUTION OF THE BONDING ADHESIVE, 2) CHANGING THE TOOL USED TO APPLY THE BONDING ADHESIVE, AND 3) ADDING DIAGRAMS TO THE MANUFACTURING INSTRUCTIONS FOR THE LEADS.
P910073|S062|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE FAMILY OF LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2006|04/28/2006|||APPR|APPROVAL FOR A TOLERANCE CHANGE TO THE ELECTRODE BASE DIAMETER, AN INCREASE IN THE ELECTRODE BASE DIAMETER, A TOLERANCE CHANGE TO THE ELECTRODE SHELL BEARING SURFACES, AND A MODIFICATION TO THE O-RING SEAT IN THE ELECTRODE SHELL TO ALL ACTIVE-FIXATION ENDOTAK RELIANCE LEADS.
P910023|S090|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PHOTON, EPIC AND ATLAS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/05/2005|01/20/2006|||APPR|APPROVAL FOR THE SOFTWARE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS RECEIVER SOFTWARE (VERSION 2.1.1).
P990020|S022|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2005|01/04/2006|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF EXPANDED STENT RINGS.
P860004|S079|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED IMPLANTABLE PUMP SYSTEM|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/02/2005|03/22/2006|||APPR|APPROVAL FOR REVISED LABELING FOR THE MANUALS FOR THE DEVICE.
P990034|S006|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED IMPLANTABLE PUMP SYSTEM|LKK|HO|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/02/2005|03/22/2006|||APPR|APPROVAL FOR REVISED LABELING FOR THE MANUALS FOR THE DEVICE.
P840064|S030|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2005|12/21/2005|||OK30|CHANGE IN SYRINGE VENDOR.
P810006|S023|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2005|12/29/2005|||OK30|MANUFACTURING EQUIPMENT CHANGE.
P850010|S020|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2005|12/29/2005|||OK30|MANUFACTURING EQUIPMENT CHANGE.
P840062|S010|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORABLE COLLAGEN WOUND DRESSING|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2005|12/29/2005|||OK30|MANUFACTURING EQUIPMENT CHANGE.
P900033|S013|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2005|12/29/2005|||OK30|MANUFACTURING EQUIPMENT CHANGE.
P010012|S084|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/05/2005|12/20/2005|||APPR|APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 MAINTENANCE RELEASE SOFTWARE (SW) VERSION 1.5.
P030005|S027|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER(CRT-P) DEVICES|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/05/2005|12/20/2005|||APPR|APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 MAINTENANCE RELEASE SOFTWARE (SW) VERSION 1.5.
P960013|S015|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC|DTB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|02/07/2006|||APPR|APPROVAL FOR THE TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST MODEL 1788 T, TENDRIL ST MODEL 1788TC, AND TENDRIL ST MODEL 1782TC.  THE TENDRIL ST MODEL 1788 LEAD IS DESIGNED FOR PERMANENT SENSING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.  THE TENDRIL ST MODEL 1782 LEAD IS DESIGNED FOR PERMANENT SENSING AND PACING IN THE RIGHT ATRIUM, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
P980018|S005|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEP TEST|MVC|PA|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2005|12/30/2005|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROL STEPS.
P000037|S009|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2005|01/06/2006|||OK30|CHANGE IN THE OPERATOR INTERFACE FOR THE PROCESS MONITORING SOFTWARE USED IN THE DIMENSIONAL INSPECTION PROCESS.
P820003|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS MODELS OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P850051|S060|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VARIOUS FAMILIES OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P900061|S059|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P930022|S002|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P970012|S019|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 FAMILY & PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980016|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980035|S051|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980050|S019|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF,GEM III AT FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P990001|S022|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P010015|S018|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC/INSYNC III CRT-IPGS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P010031|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF CRT-ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2005|12/22/2005|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P960058|S049|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/12/2005|08/17/2006|||APPR|APPROVAL FOR A MODIFICATION TO THE SOUNDWAVE PROFESSIONAL SUITE SOFTWARE (SOUNDWAVE VERSION 1.4) WHICH IMPLEMENTS AN OPTIONAL FEATURE, KNOWN AS FIDELITY 120, AND ADDS SUPPORT FOR THE AURIA HARMONY SOUND PROCESSOR.  THE SOFTWARE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE VERSION 1.4 AND IS INDICATED FOR ADULT PATIENTS AND PEDIATRIC PATIENTS AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS.  HOWEVER, THE OPTIONAL SOFTWARE CAPABILITY KNOWN AS FIDELITY 120 (SPEECH ENCODING STRATEGY) IS LIMITED FOR USE IN ADULTS WITH 1) POST-LINGUAL ONSET OF SEVERE OR PROFOUND HEARING LOSS, 2) A MINIMUM OF THREE-MONTHS EXPERIENCE WITH STANDARD HIRES, AND 3) WHO HAVE THE COGNITIVE ABILITY TO CHOOSE THE SOUND PROCESSING OPTIONS.
P000037|S010|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2005|01/10/2006|||OK30|ADDITION OF BATCH SET-UP SOFTWARE USED IN THE DIMENSIONAL MEASUREMENT PROCESS.
P860004|S080|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/2005|01/06/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE CURRENT PACKAGE LABELING FOR THE MODEL 8540 CATHETER ACCESS PORT KIT.
P020026|S016|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/2005|01/12/2006|||APPR|APPROVAL TO ADD TWO PRECAUTIONS RELATED TO THE USE OF OVERLAPPING STENTS AND TO NON-CORONARY USE TO THE INSTRUCTIONS FOR USE.
P010013|S015|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPENDANCE CONTOLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2005|06/16/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC SURGICAL PRODUCTS, MOUNTAIN VIEW, CALIFORNIA.
P820003|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS MODELS OF PACEMAKERS, MODELS SYMBIOS, SYNERGYST,SPECTRAX,PASYS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P850051|S061|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VARIOUS FAMILIES OF PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS
P900061|S060|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P930022|S003|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P970012|S020|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P980016|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P980035|S052|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS MODELS KAPPA 700/600, 800/900, SIGMA AT 500, ENPULSE, ENRHYTHM|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P980050|S020|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF, GEM III AT FAMILY OF ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P990001|S023|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P010015|S019|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC/INSYNC III CRT-IPGS, MODEL 8040/8042|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P010031|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF CRT-ICDS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P040047|S001|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE|LNM|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/09/2005|09/29/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P860019|S206|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK FAMILY PTCA BALLOON CATHETERS, MAVERICK OTW, MAVERICK2 MONORAIL (MR), QUANTUM MAVERICK OTW AND QUANTUM MAVERICK|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2005|01/10/2006|||OK30|CHANGE IN THE INSPECTION CRITERIA OF THE OUTSIDE DIAMETER OF THE PROXIMAL BALLOON WELD FROM A VISUAL INSPECTION TO AN AUTOMATED LASER PROCESS.
P010012|S085|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL PROGRAMMER SOFTWARE (SW) MODEL 2845 V4.33|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2005|04/06/2006|||APPR|APPROVAL FOR THE CONTAK RENEWAL PROGRAMMER SOFTWARE (SW) MODEL 2845 V4.33 AND APPLICABLE FIRMWARE (FW).
P910077|S057|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ZOOM LATITUDE PROGRAMMING SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2005|03/23/2007|||APPR|APPROVAL FOR THE DSP SOFTWARE UPGRADE (VERSION 1.19) OF THE MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM.
P900060|S035|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC/ VALSALVA ASCENDING AORTIC PROSTHESIS|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2005|01/13/2006|||OK30|CHANGE IN THE FELTING PROCESS OF THE PTFE FELT FILTER.
P960040|S094|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK FAMILY OF IMPLANTABLE CARIOVERTER DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2005|01/13/2006|||OK30|RECEIVING SPEAKERS WITH POLYMIDE TAPE APPLIED AND THE LEADS TRIMMED TO LENGTH BY THE SPEAKER MANUFACTURER, KNOWLES ELECTRONICS, INC.
P960052|S011|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|HIGH VISCOSITY DERMABOND MINI APPLICATOR|MPN|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2005|02/10/2006|||APPR|APPROVAL FOR THE DESIGN CHANGE OF THE HIGH VISCOSITY DERMABOND APPLICATOR SO THAT IT HAS A REDUCED FILL VOLUME COMPARED TO THE ORIGINAL HIGH VISCOSITY DERMABOND APPLICATOR (0.325 GRAMS RATHER THAN -.565 GRAMS OF THE ORIGINAL PRODUCT).  THE DEVICE, HIGH VISCOSITY DERMABOND MINI APPLICATOR, AS MODIFIED, IS INDICATED FOR ?TOPICAL APPLICATION TO HOLD CLOSED APPROXIMATED WOUND EDGES OF TRAUMA INDUCED LACERATIONS OR SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, THAT OTHERWISE COULD BE CLOSED WITH SUTURES OF U.S.P. SIZE 5-0 OR SMALLER DIAMETER, STAPLES, OR ADHESIVE STRIPS AND THAT DO NOT REQUIRE4 TOPICAL MEDICATIONS AFTER CLOSURE.?
P840001|S089|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREPRIME IMPLANTABLE NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2005|03/17/2006|||APPR|APPROVAL FOR THE MODEL 37701 RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR (INS).
P990009|S017|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2005|01/10/2006|||OK30|PACKAGING PROCESS CHANGE FOR THE BAXTER BIOSCIENCE-FREEMONT FACILITY LOCATED IN FREMONT, CALIFORNIA.
P900009|S022|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 4000+ BONE HEALING SYSTEM|LPQ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2005|06/26/2006|||APPR|APPROVAL FOR THE MODIFICATION OF THE EXISTING EXOGEN 2000+ AND EXOGEN 3000 LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEMS - SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) TO THE EXOGEN 4000+.  THE EXOGEN 4000+ IS MODIFIED TO INCORPORATE USER-INTERFACE MODIFICATIONS AND DESIGN MODIFICATIONS TO COMPENSATE FOR CHANGES IN ELECTRONIC COMPONENT AVAILABILITY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 4000+ BONE HEALING SYSTEM.  THE EXOGEN 4000+ IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTABLISHED NON-UNIONS EXCLUDING SKULL AND VERTEBRA.  IN ADDITION, IT IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FRACTURE, FOR FRESH, CLOSED, POSTERIORLY DISPLACED DISTAL RADIUS FRACTURES AND FRESH, CLOSED OR GRADE I OPEN TIBIAL DIAPHYSIS FRACTURES IN SKELETALLY MATURE INDIVIDUALS WHEN THESE FRACTURES ARE ORTHOPAEDICALLY MANAGED BY CLOSED REDUCTION AND CAST IMMOBILIZATION.
P840001|S090|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC RESTORE IMPLANTABLE NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2005|03/31/2006|||APPR|APPROVAL FOR THE MODEL 37082 DUAL QUADRIPOLAR EXTENSION KIT (8-2-4).
P830055|S094|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/2005|01/20/2006|||APPR|APPROVAL FOR A CHANGE TO THE LABELING IN THE PACKAGE INSERT OF THE DEVICE.  THIS MODIFICATION CLARIFIES THE TYPE OF LCS PATELLAR COMPONENT (LCS PFJ MODIFIED ROTATING PLATFORM PATELLA) TO BE USED WITH THE LCS PFJ TROCHLEAR COMPONENT.
P990004|S009|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN POWDER|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2005|02/02/2006|||APPR|APPROVAL FOR A 3 GRAM SIZE PACKAGE OF THE SURGIFOAM ABSORBABLE GELATIN POWDER.
P960004|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||permanent pacemaker Electrode|THINLINE 2 FINELINE 2|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2005|01/19/2006|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE ELECTRODE RING COMPONENT USED IN THE FINELINE II / THINLINE II FAMILY OF LEADS.
P020045|S014|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CCT.2 CRYOABLATION CONSOLE SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2005|04/06/2006|||APPR|APPROVAL FOR THE ADDITION OF THE FOOTSWITCH, ADDITIONAL EP CONNECTIVITY, ADDITIONAL EFFICIENCY IN VERIFICATION AND VALIDATION REPORTING, AND THE OTHER MINOR CHANGES LISTED ON PAGE 2 OF THE SUBMISSION.
P970051|S035|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24-COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2005|01/27/2006|||APPR|APPROVAL FOR THE ADDITION OF A THIN PARYLENE COATING TO THE PLATINUM STYLET THAT SUPPORTS THE CONTOUR ADVANCE ELECTRODE ARRAY, PRIOR TO AND DURING THE INSERTION PROCESS.
P030054|S020|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY/REGENCY AND FRONTIER|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2005|03/02/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.
P040043|S008|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/2005|01/20/2006|||APPR|APPROVAL FOR MODIFYING THE INSTRUCTIONS FOR USE (IFU) TO REINFORCE THE NECESSITY OF ADHERING TO THE SIZING GUIDELINES INCLUDED IN THE IFU.
P010012|S087|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/17/2006|||OK30|ALTERNATE SUPPLIER FOR ONE OF THE CAPACITOR COMPONENTS.
P960040|S096|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/17/2006|||OK30|ALTERNATE SUPPLIER FOR ONE OF THE CAPACITOR COMPONENTS.
P010012|S088|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|ALTERNATE DIODE SUPPLIER.
P960040|S097|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY, PRIZM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|ALTERNATE DIODE SUPPLIER.
P960040|S098|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|ADDING NEW SUPPLIER FOR THE GOLD BUMPING PROCESS.
P010012|S089|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|ADDING NEW SUPPLIER FOR THE GOLD BUMPING PROCESS.
P010012|S090|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGE IN THE INSPECTION CRITERIA FOR CATHODE FOIL COMPONENTS USED ON ALUMINUM ELECTROLYTIC CAPACITORS.
P960040|S099|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGE IN THE INSPECTION CRITERIA FOR CATHODE FOIL COMPONENTS USED ON ALUMINUM ELECTROLYTIC CAPACITORS.
P010012|S091|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/17/2006|||OK30|CHANGE IN EQUIPMENT USED FOR LEAD INSPECTION, AND A CHANGE IN BONDING THE SERIAL NUMBER LABEL.
P010012|S092|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 RF|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/19/2006|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A LEAD SEAL COMPONENT.
P960040|S100|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM AICD SYSTEM MODELS 1850, 1853, AND 1900|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2006|04/24/2006|||APPR|APPROVAL FOR THE RETROACTIVE MANUFACTURE PROCESS MODIFICATION BY INSERTING A COATING OF MEDICAL ADHESIVE AROUND THE FEEDTHRU WIRES OF THE PRIZM AICD SYSTEM MODELS 1850, 1853, AND 1900.
P960040|S102|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR THE TRANSFORMER COMPONENT.
P010012|S094|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL|LWP|CV|30-Day Notice||N|12/21/2005|01/20/2006|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR THE TRANSFORMER COMPONENT.
P010012|S095|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|UPDATE THE HYBRID TEST SOFTWARE INCORPORATING MODIFICATIONS TO SEVERAL DEVICE FUNCTIONAL TESTS.
P010012|S096|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGES TO THE ADHESIVE FOR BONDING THE OUTER SLEEVES AND SEAL PLUGS TO THE DEVICE HEADER.
P960040|S103|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY, PRIZM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGES TO THE ADHESIVE FOR BONDING THE OUTER SLEEVES AND SEAL PLUGS TO THE DEVICE HEADER.
P030005|S028|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGES TO THE ADHESIVE FOR BONDING THE OUTER SLEEVES AND SEAL PLUGS TO THE DEVICE HEADER.
P940031|S049|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY, MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGES TO THE ADHESIVE FOR BONDING THE OUTER SLEEVES AND SEAL PLUGS TO THE DEVICE HEADER.
P010012|S097|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL, CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGE IN THE CAPACITOR SPIKE LIMIT.
P960040|S104|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|05/05/2006|||APPR|CHANGE FROM A MANUAL TO AN AUTOMATED INSPECTION OF THE SOLDER BALLS ON BALL GRID ARRAY MODULES.
P960040|S105|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY, PRIZM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/20/2006|||OK30|CHANGE IN THE CAPACITOR SPIKE LIMIT.
P010012|S098|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|04/20/2006|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING TEST SOFTWARE AND MANUFACTURING PROCESS SEQUENCES.
P010012|S099|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|05/05/2006|||APPR|CHANGE FROM A MANUAL TO AN AUTOMATED INSPECTION OF THE SOLDER BALLS ON BALL GRID ARRAY MODULES.
P030005|S029|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|05/05/2006|||APPR|CHANGE FROM A MANUAL TO AN AUTOMATED INSPECTION OF THE SOLDER BALLS ON BALL GRID ARRAY MODULES.
P960040|S106|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY FAMILY OF ICDS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|04/20/2006|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING TEST SOFTWARE AND MANUFACTURING PROCESS SEQUENCES.
P010012|S100|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|GUIDANT EASY-TRACK 2 LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/11/2006|||OK30|REDUCTION IN THE LEAD TERMINAL POSTING CURE TIME.
P010012|S101|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/19/2006|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE RESISTOR ARRAYS.
P960040|S107|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY, PRIZM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2005|01/19/2006|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE RESISTOR ARRAYS.
P890003|S097|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS, REVEAL PLUS & BOSS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2005|05/12/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS
P960004|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|THINLINE II/ FINELINE II|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2005|01/19/2006|||OK30|ADDITION OF SECOND SUPPLIER FOR THE TUBING USED AS THE MAIN BODY TUBING ON THE FINELINE II / THINLINE II FAMILY OF LEADS.
P960004|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FINELINE MODEL 6066|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2005|01/17/2006|||OK30|ADDITIONAL SUPPLIER FOR THE STYLET/RING ASSEMBLY USED IN CONJUNCTION WITH THE FINELINE FAMILY OF LEADS.
P960004|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FINELINE II / THINLINE II  FAMILY OF LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2005|01/19/2006|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE CONDUCTOR COIL USED IN THE FINELINE II / THINLINE II   FAMILY OF LEADS.
P010051|S004|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2005|06/16/2006|||APPR|APPROVAL FOR REVISION OF THE ANALYTICAL SENSITIVITY CLAIM FOR THE IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC ASSAYS.
P890003|S098|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2005|08/30/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE AT TECHNICAL SERVICES FOR ELECTRONICS, INC., ARLINGTON, MINNESOTA.
P820003|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS FAMILIES OF PACEMAKERS|LWP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2005|08/30/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE AT TECHNICAL SERVICES FOR ELECTRONICS, INC., ARLINGTON, MINNESOTA.
P040012|S003|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/22/2005|03/16/2006|||APPR|APPROVAL OF MODIFICATIONS TO THE PROTOCOL FOR THE ARCHER LONG TERM FOLLOW-UP (LTFU) TRIAL.  THE REVISED PROTOCOL INCLUDES MEASURES DESIGNED TO ASSIST IN THE RECRUITMENT AND EVALUATION OF PATIENTS, AND COMPLIES WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE AUGUST 30, 2004 APPROVAL ORDER FOR P040012.
P910023|S091|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2005|01/10/2006|||OK30|USE OF AN AUTOMATED SOLDERING SYSTEM FOR THE SOLDERING OF THE SENSOR FLEX AND HVPCB ASSEMBLIES.
P960058|S050|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2005|01/17/2006|||OK30|APPROVAL OF THE REDUCED RESIDUAL GAS ANALYSIS (RGA-A DESTRUCTIVE TEST) LOT SAMPLING FOR THE HIRES90K IMPLANT.
P010012|S102|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL RF PULSE GENERATORS|LWP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2005|01/26/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT IRELAND, TIPPERARY, IRELAND.
P980022|S014|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN RT|MDS|CH|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/27/2005|12/27/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P790007|S017|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT, MODEL 150|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2005|04/20/2006|||APPR|APPROVAL FOR THE IMPLEMENTATION OF SMALLER CAPACITY EQUIPMENT AND ELIMINATION OF THE SHRINK TEMPERATURE TESTING USED FOR THE TISSUE FIXATION MANUFACTURING PROCESS.
P980043|S007|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 ANF T510|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2005|04/20/2006|||APPR|APPROVAL FOR THE IMPLEMENTATION OF SMALLER CAPACITY EQUIPMENT AND ELIMINATION OF THE SHRINK TEMPERATURE TESTING USED FOR THE TISSUE FIXATION MANUFACTURING PROCESS.
P990064|S012|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2005|04/20/2006|||APPR|APPROVAL FOR THE IMPLEMENTATION OF SMALLER CAPACITY EQUIPMENT AND ELIMINATION OF THE SHRINK TEMPERATURE TESTING USED FOR THE TISSUE FIXATION MANUFACTURING PROCESS.
P970031|S014|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2005|04/20/2006|||APPR|APPROVAL FOR THE IMPLEMENTATION OF SMALLER CAPACITY EQUIPMENT AND ELIMINATION OF THE SHRINK TEMPERATURE TESTING USED FOR THE TISSUE FIXATION MANUFACTURING PROCESS.
P960009|S036|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS LEADS|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/28/2005|03/02/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 3387/3398 DBS LEAD KIT INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE SYSTEMS FOR DBS.  THE MODIFICATIONS SPECIFIED WERE: TO REMOVE THE PERCUTANEOUS EXTENSION, TO ADD A LEAD CAP, AND TO BUNDLE THE MEDTRONIC IMAGE-GUIDED NEUROLOGICS STIMLOC KIT (BURR HOLE COVER ASSEMBLY) WITH THE DBS LEAD KIT.
P990064|S013|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC BIOPROSTHESIS MODELS 305 AND 310|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2005|01/27/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED MACHINING PROCESS FOR THE BARE STENT COMPONENT.
P980043|S008|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2005|01/27/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED MACHINING PROCESS FOR THE BARE STENT COMPONENT.
P010015|S020|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC REGISTRY|LWP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/30/2005|06/28/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL STUDY FOR THE DEVICE.
P030019|S008|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2006|01/30/2006|||OK30|CHANGE IN THE BULK CONCENTRATE PROCESS TO NO LONGER INCLUDE THE CHLOROFORM TREATMENT STEP.
P000046|S013|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II, SHELLGEL AND COEASE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2006|01/24/2006|||OK30|REMOVAL OF THE CHLOROFORM TREATMENT STEP FROM THE MANUFACTURING PROCESS.
P900023|S044|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/05/2006|07/07/2006|||APPR|APPROVAL FOR DESIGN CHANGES TO INTEGRATE THE PREVIOUSLY APPROVED 42 FR. VENTRICULAR/ATRIAL CANNULA AND PREVIOUSLY APPROVED SEWING CUFF ACCESSORY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 42 FR. VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF AND IS INDICATED FOR USE WITH THE BVS 5000 BIVENTRICULAR SUPPORT SYSTEM AND WITH THE AB5000 CIRCULATORY SUPPORT SYSTEM.
P050007|S001|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/2005|02/02/2007|07M-0058|02/21/2007|APPR|APPROVAL FOR THE STARCLOSE VASCULAR CLOSURE SYSTEM.  THIS DEVICE IS INDICATED AS FOLLOWS:THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.
P850049|S009|COOK, INC.|P.O. BOX 489||BLOOMINGTON|IN|47402||FILTER, INTRAVASCULAR, CARDIOVASCULAR|BIRD'S NEST VENA CAVA FILTER|DTK|CV|30-Day Notice||N|01/05/2006|02/03/2006|||OK30|CHANGE TO THE STERILIZATION TYPE WITHIN THE SAME FACILITY.
P980035|S053|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC P1501 DR ENRHYTHM IPG SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/09/2006|02/22/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9987 APPLICATION SOFTWARE VERSION 1.3 AND VERSION 1.5 FOR MEDTRONIC ENRHYTHM IPG AND ENTRUST ICD SYSTEMS.
P020018|S008|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|COOK ZENITH RENU AAA ANCILLARY GRAFT|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2006|02/09/2006|||APPR|APPROVAL FOR MODIFYING THE INSTRUCTIONS FOR USE (IFU) FOR THE COOK ZENITH. RENU AAA ANCILLARY GRAFT TO REINFORCE THE PRECAUTION NOT TO INFLATE THE MOLDING BALLOON IN THE VESSEL OUTSIDE THE GRAFT.
P040024|S004|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2006|01/27/2006|||APPR|APPROVAL FOR ADDITIONAL TEXT TO THE PRECAUTIONS SECTION OF THE LABELING REGARDING DELAY-ONSET, PROLONGED REACTIONS.
P980016|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ENTRUST MODELS D153ATG, D153DRG,D153VRC,D254ATG,D154DRG,D154VRC|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/09/2006|02/22/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9987 APPLICATION SOFTWARE VERSION 1.3 AND VERSION 1.5 FOR MEDTRONIC ENRHYTHM IPG AND ENTRUST ICD SYSTEMS.
P030035|S006|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2006|03/02/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.
P830045|S093|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PROGRAMMERS TO SUPPORT VARIOUS PACEMAKERS AND DEFIBRILLATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2006|03/02/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.
P880006|S036|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2006|03/02/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.
P910023|S092|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2006|03/02/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.
P970013|S003|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PULSE GENERATORS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2006|03/02/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.
P880086|S113|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IMPLANTABLE PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2006|03/02/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.
P050009|S001|Biomet, Inc.|P.O. Box 587||Warsaw|IN|46581|0587|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|C2A-TAPER ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2006|02/01/2006|||OK30|MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC. FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.
P040002|S003|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2006|02/01/2006|||OK30|SWITCH FROM TWO-PART EPOXY REQUIRING 48-HOUR CURE TIME TO TWO-PART EPOXY REQUIRING 1-HOUR CURE TIME.
P000010|S005|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2006|01/25/2006|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P000012|S006|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2006|01/25/2006|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P900060|S036|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2006|02/01/2006|||OK30|INCREASE IN THE STERILIZATION DWELL TIME FROM 30 TO 35 MINUTES.
P010018|S009|REFRACTEC, INC.|5 JENNER, SUITE 150||IRVINE|CA|92618||Electrosurgical,radio frequency,refractive correction|VIEWPOINT CK SYSTEM|MWD|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2006|04/06/2006|||APPR|APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS FOR CK TREATMENT TO IMPROVE NEAR VISION IN THE EMMETROPIC AND HYPEROPIC PRESBYOPES.
P000032|S016|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2006|02/02/2006|||OK30|USE OF AN ALTERNATE RESISTOR SUPPLIER AND A CHANGE IN THE RESISTOR'S ASSEMBLY PROCESS.
P800022|S053|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM/ZYPLAST COLLAGEN, COSMODERM/ COSMOPLAST HUMAN COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2006|11/03/2006|||APPR|APPROVAL FOR A STERILIZATION SITE AND METHOD CHANGE LOCATED AT SERIGENICS US, LLC, CORONA, CALIFORNIA.
P860004|S081|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|01/13/2006|03/22/2006|||APPR|APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDING A SUTURELESS PUMP CONNECTOR TO BOTH MODELS 8709 AND 8731 CATHETERS COMPATIBLE WITH THE SYNCHROMED AND ISOMED IMPLANTABLE INFUSION PUMPS; 2) ADDING NUMBERS (IN CENTIMETERS) TO THE MARKINGS ON THE 8709 CATHETER BODY LIKE THOSE ON THE 8731 CATHETER; 3) ADDING A SHORTER (9.3 CM) INTRODUCER NEEDLE TO THE MODEL 8731 KIT; 4) ADDING CONNECTOR PINS AND STRAIN RELIEF SLEEVES TO MODEL 8731 CATHETER KIT ALLOWING THE PUMP SEGMENT OF THE CATHETER TO BE TRIMMED; 5) CREATE MODEL 8578 AS A REVISION KIT FOR 8709 OR 8709SC (SUTURELESS CONNECTOR) CONTAINING THE SUTURELESS CONNECTOR SEGMENT AND STRAIN RELIEF SLEEVES; 6) ADDING MODEL 8598A FOR CURRENT 8598 KIT (8731 SPINAL CATHETER SEGMENT REVISION KIT) MODIFIED TO CONTAIN THE SHORTER (9.3 CM) INTRODUCER NEEDLE; AND 7) MODEL 8596SC AS THE PUMP CONNECTOR IN THE CURRENT 8596 KIT (8731 PUMP CATHETER SEGMENT REVISION KIT) WAS REPLACED WITH THE SUTURELESS PUMP CONNECTOR.
P910071|S008|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL OL 5000 SILICONE OIL|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2006|02/24/2006|||OK30|REMOVAL OF THE HEAT STERILIZATION SUB-LOT SUFFIX FROM THE LABELING.
P910023|S093|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST. JUDE MEDICAL ICDS/CRT-DS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2006|04/20/2006|||APPR|APPROVAL FOR AN ALTERNATE SILICONE DIODE DIE FOR HYBRID ASSEMBLIES.
P980049|S022|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|VARIOUS DEFENDER & ALTO ICDS MODELS & ORCHESTRA PROGRAMMER|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/17/2006|03/15/2006|||APPR|APPROVAL FOR THE HARDWARE MODIFICATION OF THE CPR3 PROGRAMMING HEAD TO BE USED WITH ALL THE ELA?S ICD AND PACEMAKER SYSTEMS.
P980016|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACCELEROMETER TANTALUM CAPACITOR CHANGE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/17/2006|03/02/2006|||APPR|APPROVAL FOR A CHANGE IN HYBRID COMPONENTS, THE ACCELEROMETER (XE407) AND TANTALUM CAPACITOR (XT122) FOR THE PRODUCTS PREVIOUSLY LISTED.
P010031|S034|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/17/2006|03/02/2006|||APPR|APPROVAL FOR A CHANGE IN HYBRID COMPONENTS, THE ACCELEROMETER (XE407) AND TANTALUM CAPACITOR (XT122) FOR THE PRODUCTS PREVIOUSLY LISTED.
P910023|S094|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST JUDE MEDICAL HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2006|02/16/2006|||OK30|MODIFICATIONS TO THE CONNECTOR AND CRYSTAL COMPONENTS OF THE TRANSMITTER USED IN THE HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM.
P000032|S017|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/17/2006|02/16/2006|||APPR|APPROVAL FOR A CHANGE TO THE QUALITY TESTS USED TO EVALUATE THE THERMOCOUPLE WIRING IN THE DISPOSABLE CONTROL UNIT (DCU) AND FOR A CHANGE TO THE LABELING TO INCLUDE ADDITIONAL PRECAUTIONS/INSTRUCTIONS FOR THE YEAR.
P000043|S010|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/17/2006|02/08/2007|||APPR|APPROVAL FOR AN UPGRADE OF THE DEVICE INCLUDING A MODIFICATION OF THE MAIN CONSOLE, COMPUTER AND SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH F 25 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC.
P030039|S002|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT, PREMIXED|NBE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2006|11/03/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAXTER HEALTHCARE CORPORATION, HAYWARD, CALIFORNIA.
P980041|S007|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2006|01/30/2006|||OK30|CHANGES TO THE ACCESS, ACCESS 2 AND SYNCHRON LXI 725 ANALYZER OPERATING SOFTWARE TO REMOVE THE DIL-AFP ASSAY PROTOCOL AND RESTORE THE SYSTEMS TO THEIR ORIGINAL FUNCTIONALITY.
P990025|S010|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER,QWIKSTAR DIAGNOSTIC ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2006|02/16/2006|||OK30|CHANGE IN THE PRODUCT RELEASE.
P990025|S011|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|QWIKSTAR NAVIGATION/ABLATION CATHETER|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/18/2006|03/28/2006|||APPR|APPROVAL FOR A MINOR LABELING REVISION FOR THE 4 MM QWIKSTAR DIAGNOSTIC/ABLATION CATHETER TO INCLUDE THE NOGA XP NAVIGATION SYSTEM AS AN OPTIONAL MAPPING SYSTEM FOR THE QWIKSTAR CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGICAL MAPPING AND FOR USE WITH COMPATIBLE RADIO-FREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.  WHEN USED IN THE CARTO XP EP OR NOGA XP NAVIGATION SYSTEMS, THE QWIKSTAR DIAGNOSTIC/ABLATION CATHETER PROVIDES LOCATION INFORMATION AND APPROXIMATE CATHETER TIP CURVATURE.
P970035|S046|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S660 OVER THE WIRE CORONARY STENT SYSTEM, S660 ZIPPER MX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2006|02/01/2006|||OK30|MANUFACTURING PROCESS CHANGE TO ELIMINATE THE POST-ANNEALING METALLOGRAPHY INSPECTION.
P000010|S006|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2006|02/17/2006|||OK30|CHANGES IN THE TESTING PARAMETERS USED TO CONSTRUCT A SPECIFIC CONJUGATE, AND AN UPGRADE IN THE HPLC SOFTWARE.
P000012|S007|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2006|02/17/2006|||OK30|CHANGES IN THE TESTING PARAMETERS USED TO CONSTRUCT A SPECIFIC CONJUGATE, AND AN UPGRADE IN THE HPLC SOFTWARE.
P950024|S007|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC CAPSUREEPI PACING LEADS|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/30/2005|04/04/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL STUDY FOR THE DEVICE.
P910023|S095|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2006|02/16/2006|||OK30|CHANGE FROM A MANUAL TESTING PROCESS OF THE FLEX FEED THRU ASSEMBLY PROCESS TO AN AUTOMATED PROCESS.
P000012|S008|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice||N|01/10/2006|01/25/2006|||OK30|CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
P990001|S024|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C60 DR MODEL C60A3, VITATRON C20 SR MODEL C20A3, VITATRON T60 DR MODEL T60A1, AND VITATRON T20 SR MODEL T20A1|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/19/2006|03/31/2006|||APPR|APPROVAL FOR SOFTWARE REVISIONS.
P890017|S014|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|CORDIS PALMAZ BALLOON-EXPANDABLE STENT FOR THE ILIAC AND RENAL ARTERIES|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/20/2006|04/21/2006|||APPR|APPROVAL TO CHANGE THE BACTERIAL ENDOTOXIN TEST METHOD TO THE KINETIC CHROMOGENIC LAL TEST METHOD, PER 2005 USP 28, NF23, CHAPTER <85>.
P010017|S007|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Full field digital,system,x-ray,mammographic|FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/20/2006|02/13/2006|||APPR|APPROVAL FOR SOFTWARE CHANGES TO CORRECT SEVERAL "BUGS" THAT IMPROVE SERVICE WORKFLOW EFFICIENCY, IMPROVE USER WORKFLOW EFFICIENCY, AND IMPROVE IMAGE ARCHIVING.
P840001|S091|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/2006|02/08/2006|||APPR|APPROVAL FOR REVISED TEXT TO THE CAUTION IN THE "PLACING A PERCUTANEOUS LEAD" SECTION OF THE INSTRUCTIONS FOR USE SECTION OF THE FOLLOWING MANUALS:  MODEL 3898 PISCES-OCTAD LEAD KIT IMPLANT MANUAL, MODEL 3487 A PISCES QUAD, MODEL 3887 PISCES QUAD COMPACT, AND MODEL 3888 PISCES QUAD PLUS LEAD KITS IMPLANT MANUAL, AND MODEL 3890 PISCES Z QUAD, MODEL 3891 PISCES Z QUAD COMPACT, AND MODEL 3892 PISCES Z QUAD PLUS LEAD KITS IMPLANT MANUAL.
P980016|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC EN-TRUST 30J/35J ICD FAMILY|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/23/2006|03/02/2006|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE ICR (INTERCONNECT RIBBON) THAT CONNECTS THE FEEDTHROUGHS TO THE CONNECTOR MODULE BLOCKS AND MULTI BEAM CONTACTS FOR THE MEDTRONIC ENTRUST 30J/35J ICD FAMILY (D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC).  SPECIFICALLY, THE INTERCONNECT RIBBON (ICR) THAT CONNECTS THE FEEDTHROUGHS TO THE CONNECTOR MODULE BLOCKS AND MULTI BEAM CONTACTS IS BEING MODIFIED TO PROVIDE A LAP-WELD JOINT AND THE BONDING OF THE SAME MATERIALS.
P990056|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/23/2006|04/12/2006|||APPR|APPROVAL FOR IMPLEMENTATION OF AN ADDITIONAL STEP INTO THE STANDARDIZATION INSTRUCTIONS FOR THE ELECSYS TOTAL PSA IMMUNOASSAY.
P040001|S001|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|01/23/2006|12/08/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P010032|S019|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON AND GENESIS RC NEUROSTIMULATION SYSTEMS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/23/2006|12/13/2007|||APPR|APPROVAL FOR INCREASING THE BATTERY LONGEVITY CLAIM FOR SEVEN YEARS TO 10 YEARS.
P970051|S036|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (CI24R & CI24RE MODELS)|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2006|02/27/2006|||OK30|IMPLEMENTATION OF THREE MANUFACTURING PROCESS CHANGES FOR CI24R AND CI24RE MODEL COCHLEAR IMPLANTS POWDER INJECTION-MOULDED (PIM) CERAMIC FEEDTHROUGH ASSEMBLY.
P000039|S015|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|THE AMPLATZER SEPTAL OCCLUDER|MAE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/23/2006|02/22/2006|||APPR|APPROVAL FOR LABELING CHANGES TO ADDRESS REPORTED ADVERSE EVENTS SUCH AS TISSUE EROSION/PERFORATION AND DEVICE EMBOLIZATION.
P030054|S021|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE MODEL 1056K LEAD|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2006|02/24/2006|||OK30|CHANGE IN VENDORS FOR THE TUBING MATERIAL.
P010068|S008|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER,|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2006|02/16/2006|||OK30|CHANGE IN THE PRODUCT RELEASE.
P950005|S020|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER, CELSIUS DIAGNOSTIC|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2006|02/16/2006|||OK30|CHANGE IN THE PRODUCT RELEASE.
P030031|S003|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR THERMOCOLD DIAGNOSTIC DEFLECTABLE TIP CATHETER, CEL|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2006|02/16/2006|||OK30|CHANGE IN THE PRODUCT RELEASE.
P860047|S019|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT|LZP|OP|Normal 180 Day Track No User Fee|Express GMP Supplement|N|01/24/2006|12/21/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT 8500 HIDDEN RIVER PARKWAY, TAMPA, FLORIDA.
P010062|S004|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|RIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY)|NUU|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2006|05/30/2006|||APPR|APPROVAL FOR THE ADDITION OF A COLD OXYGEN PLASMA TREATMENT STEP TO THE CURRENT MANUFACTURING PROCESS FOR THE BOSTON EQUALENS (ITAFLUOROFOCON A), BOSTON EQUALENS II, AND BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
P970003|S063|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY PULSE GENERATOR, LEAD AND PATIENT KIT|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/2006|06/29/2006|||APPR|APPROVAL FOR LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN, PULSE GENERATOR, LEAD AND PATIENT KIT LABELING.
P860022|S056|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens,contact(rigid gas permeable)-extended wear|BOSTON EQUALENS (ITAFLUOROFOCON A AND OPRIFOCON A)|MWL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2006|05/30/2006|||APPR|APPROVAL FOR THE ADDITION OF A COLD OXYGEN PLASMA TREATMENT STEP TO THE CURRENT MANUFACTURING PROCESS FOR THE BOSTON EQUALENS (ITAFLUOROFOCON A), BOSTON EQUALENS II, AND BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
P020050|S004|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2006|07/26/2006|06M-0325|08/17/2006|APPR|APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO ANALYZER.  THE DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.0 MM ABLATION/TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF UP TO -7.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 D OF SPHERICAL COMPONENT AND UP TO 3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P030027|S001|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002|0000|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2006|02/16/2006|||OK30|MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC., FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS
P950029|S025|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|VARIOUS MODELS OF RATE-RESPONSIVE PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/30/2006|03/15/2006|||APPR|APPROVAL FOR THE HARDWARE MODIFICATION OF THE CPR3 PROGRAMMING HEAD TO BE USED WITH ALL THE ELA?S ICD AND PACEMAKER SYSTEMS.
P000010|S007|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|01/31/2006|06/22/2006|||APPR|APPROVAL FOR THE EXTENSION OF THE SHELF LIFE TO 24 MONTHS OF THE HCV MASTER MIX, VERSION 2,.0, A COMPONENT OF THE AMPLICOR HCV TEST, V2.0.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPLICOR HCV TEST, V2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF HCV RNA INHUMAN SERUM OR PLASMA FROM BLOOD COLLECTED IN EDTA (EDTA PLASMA).  THE TEST DETECTS BY REVERSE TRANSCRIBING TARGET HCV RNA IN COMPLIMENTARY DNA (CDNA), AMPLIFYING CDNA BY POLYMERASE CHAIN REACTION (PCR), HYBRIDIZING AMPLIFIED CDNA WITH AN OLIGONUCLEOTIDE PROBE THAT BINDS ENZYME, AND CATALYZING CONVERSION OF SUBSTRATE TO A COLORED PRODUCT THAT IS RECOGNIZED BY A MICROWELL PLATE READER.  THE AMPLICOR HCV TEST, V2.0 IS INDICATED FOR PATIENTS WHO HAVE EVIDENCE OF LIVER DISEASE AND ANTIBODY EVIDENCE OF HCV INFECTION, AND WHO ARE SUSPECTED TO BE ACTIVELY INFECTED WITH HCV.  DETECTION OF HCV RNA INDICATES THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE HCV INFECTION.
P910023|S097|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PHOTON MICRO & ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2006|02/16/2006|||OK30|CHANGE IN THE VERIFICATION TESTING PERFORMED BY THE BATTERY VENDOR.
P010068|S009|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR RMT DS CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2006|03/21/2007|||APPR|APPROVAL FOR ADDING REMOTE MAGNETIC NAVIGATION TECHNOLOGY TO THE PREVIOUSLY APPROVED CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NAVISTAR RMT DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING (STIMULATION AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR (WITH SOFTWARE VERSION 001/033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS 18 OR OLDER.  THE NAVISTAR RMT DS CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO RMT EP NAVIGATION SYSTEM.  THE NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE CATHETER IS ONLY FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS).  COMPATIBILITY WITH THE STEREOTAXIS CARDIODRIVE HAS NOT BEEN DETERMINED.
P000012|S009|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|01/31/2006|06/16/2006|||APPR|APPROVAL FOR THE EXTENSION OF THE SHELF LIFE TO 24 MONTHS OF THE HCV MASTER MIX, VERSION 2.0, A COMPONENT OF THE COBAS AMPLICOR HCV TEST, V2.0.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLICOR HCV TEST, V2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF HCV RNA IN HUMAN SERUM OR PLASMA FROM BLOOD COLLECTED IN EDTA (EDTA PLASMA).  THE TEST DETECTS BY REVERSE TRANSCRIBING TARGET HCV RNA IN COMPLIMENTARY DNA (CDNA), AMPLIFYING CDNA BY POLYMERASE CHAIN REACTION (PCR), HYBRIDIZING AMPLIFIED CDNA WITH AN OLIGONUCLEOTIDE PROBE THAT BINDS ENZYME, AND CATALYZING CONVERSION OF SUBSTRATE TO A COLORED PRODUCT THAT IS RECOGNIZED BY THE COBAS AMPLICOR ANALYZER.  THE COBAS AMPLICOR HCV TEST, V2.0 IS INDICATED FOR PATIENTS WHO HAVE EVIDENCE OF LIVER DISEASE AND ANTIBODY EVIDENCE OF HCV INFECTION, AND WHO ARE SUSPECTED O BE ACTIVELY INFECTED WITH HCV.
N16837|S004|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2006|03/02/2006|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE BOVINE CAROTID ARTERY COMPONENT OF THE DEVICE.
P970043|S025|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/2006|07/05/2006|||APPR|APPROVAL FOR AN EXPANSION OF THE ALLOWABLE RANGE FOR THE PHYSICIAN ADJUSTMENT OF DEFOCUS OFFSET PARAMETER FOR THE WAVEFRONT-GUIDED MYOPIA AND MYOPIC ASTIGMATISM INDICATIONS FROM +=0.75 D TO UP TO 1.00 D INCREASE (MORE MYOPIC TREATMENT) AND UP TO 2.50 D DECREASE (LESS MYOPIC TREATMENT).
P030039|S003|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/2006|03/10/2006|||APPR|APPROVAL FOR LABELING CHANGE TO ADD A WARNING REGARDING USE OF THE SEALANT TO ADHERE OBJECTS TO TISSUE.
P970003|S064|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2006|05/04/2006|||APPR|APPROVAL FOR THE VNS THERAPY PERENNIA MODEL 303 LEAD.
P890003|S099|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITORS, MODELS 2490G, 2490H, 2490J|NVZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2006|02/28/2006|||APPR|APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
P900061|S061|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM MODEL 7227 IMPLANTABLE DEVICE|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2006|02/28/2006|||APPR|APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
P980016|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC, INTRINSIC 30 IMPLANTABLE DEVICES|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2006|02/28/2006|||APPR|APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
P010031|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MAQUIS, INSYNC MAXIMO, INSYNC SENTRY AND IMSYNC II MARQUIS IMPLANTABLE DEVICES|NIK|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2006|02/28/2006|||APPR|APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
P830045|S094|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON,PHOENIX, MULTILOG, AND SENSORITHM PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/2006|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P880006|S037|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|REGENCY, SENSOLOG III, DIALOG II PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/2006|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P820018|S074|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA/QUADRA, REFLEX, SIMPLEX,META PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/2006|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P880086|S114|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/2006|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P970013|S004|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/2006|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P030035|S007|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/2006|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P910023|S098|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|SJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS)|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/02/2006|04/05/2006|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE HIGH VOLTAGE CAPACITOR, BATTERY, FEEDTHRUS/HEADERS AND DISCRETE COMPONENTS.  SPECIFICALLY, ALTERATION OF THE BATTERY PIN CONFIGURATION, MODIFICATION OF THE FEEDTHRU WIRE TUBING LENGTHS AND OF THE METHOD USED FOR APPLYING INSULATION, CHANGE IN THE VALUE OF C36 CAPACITOR FROM 10NF TO 680PF, QUALIFICATION OF AN ALTERNATE ACCELEROMETER SUBSTRATE WITH INTEGRATED RESISTOR CAPACITOR, AND THE SHIFTING OF THE ANCHOR BRIDGE TO FEEDTHRU FLANGE FROM 0.17" TO 0.18".
P040024|S005|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2006|03/03/2006|||APPR|APPROVAL FOR QUALITY CONTROL CHANGE THAT PROVIDES FOR ADDITIONAL ASSURANCE OF THE PURITY OF RESTYLANE INJECTABLE GEL DEVICE REGARDING ENDOTOXIN LEVEL.
P020009|S024|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2006|03/02/2006|||OK30|MODIFICATION OF THE EQUIPMENT NOZZLE TO THE MOLD USED FOR MAKING THE MANIFOLD OF THE ABOVE-STATED DEVICES.
P860019|S207|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PERCUTANEOUS TRANSPLUMINAL CORONARY ANGIOPLASTY CATHETERS MAVERICK2 MONORAIL PTCA CATHETERS AND NC MONORAIL PTCA CATHETE|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2006|03/02/2006|||OK30|MODIFICATION OF THE EQUIPMENT NOZZLE TO THE MOLD USED FOR MAKING THE MANIFOLD OF THE ABOVE-STATED DEVICES.
P030054|S022|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF & ATLAS + HF|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2006|03/07/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 2.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P990064|S014|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2006|06/05/2006|||APPR|APPROVAL FOR MODIFICATIONS TO: 1) THE JAR RETAINER USED FOR BOTH THE MITRAL AND AORTIC CONFIGURATIONS OF THE MOSAIC BIOPROSTHESES; 2) THE SERIAL NUMBER TAG FOR MITRAL AND AORTIC CONFIGURATIONS OF THE MOSAIC BIOPROSTHESES; 3) THE VALVE HOLDER FOR THE MOSAIC MITRAL BIOPROSTHESES, AND 4) THE "INSTRUCTIONS FOR USE": TO ACCOMMODATE THE CHANGES IN THE RETAINER, TAG AND MITRAL HOLDER.
P980043|S009|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2006|06/05/2006|||APPR|APPROVAL FOR MODIFICATIONS TO: 1) THE JAR RETAINER USED FOR BOTH THE MITRAL AORTIC CONFIGURATIONS OF HANCOCK II BIOPROSTHESES; 2) THE SERIAL NUMBER TAG FOR MITRAL AND AORTIC CONFIGURATIONS OF THE HANCOCK  II BIOPROSTHESES; 3) THE VALVE HOLDER FOR THE HANCKCK II MITRAL BIOPROTHESES; AND 4) THE "INSTRUCTIONS FOR USE" TO ACCOMMODATE THE CHANGES IN THE RETAINER, TAG AND MITRAL HOLDER.
P960013|S016|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2006|03/02/2006|||OK30|ADDITION OF AN INSPECTION FOR MEDICAL ADHESIVE ON THE HELIX DURING PRODUCTION.
P020009|S025|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2006|03/03/2006|||OK30|CHANGES TO THE MANDREL.
P030025|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2006|03/03/2006|||OK30|CHANGES TO THE MANDREL.
P040016|S008|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2006|03/03/2006|||OK30|CHANGES TO THE MANDREL.
P010012|S103|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY DEVICES|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2006|05/19/2006|||APPR|APPROVAL FOR CHANGES TO THE TEST SOFTWARE AND TEST HARDWARE USED DURING ELECTRICAL TESTING OF THE MIXED MODE INTEGRATED CIRCUIT (MMIC).
P960040|S108|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY FAMILY OF ICDS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2006|05/19/2006|||APPR|APPROVAL FOR CHANGES TO THE TEST SOFTWARE AND TEST HARDWARE USED DURING ELECTRICAL TESTING OF THE MIXED MODE INTEGRATED CIRCUIT (MMIC).
P850022|S016|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/2006|07/27/2006|||APPR|APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1) THE STIMULATOR HAS BEEN MODIFIED TO INCLUDE: A) A NEW USER INTERFACE (SIMILAR TO P850022/S015).  THE USER INTERFACE INCLUDES AN ALARM BUTTON, YELLOW LED, AND A LCD DISPLAY TO INDICATE TREATING STATUS; B) AN AUDIBLE AND VISIBLE SELF-CHECKING ALARM MECHANISM WITH ADDITIONAL MALFUNCTION SOURCE INDICATORS (SAME AS P850022/S015).  THE AUDIBLE ALARM MECHANISM CAN BE DISABLED USING THE ALARM BUTTON; C) A NEW MAIN PCB CIRCUIT BOARD (SAME AS P850022/S015); D) SOFTWARE C PROGRAM LANGUAGE (SAME AS P850022/S015); E) AN ELAPSED TIME ACCUMULATOR/PATIENT MONITORING FUNCTION (SIMILAR TO P850022/S015).  AFTER 270 DAYS OF ELAPSED TREATMENT TIME OR 400 DAYS OF TOTAL ACTIVATION TIME THE 7UNIT WILL NO LONGER GENERATE A SIGNAL. 2) THE POWER SOURCE HAS BEEN MODIFIED FROM A DISPOSABLE BATTERY TO A RECHARGEABLE NIMH "AA" BATTERY.  THE DEVICE INCLUDES TWO RECHARGEABLE BATTERIES AND A SINGLE CELL BATTERY CHARGER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ORTHOPAK2 BONE GROWTH STIMULATOR SYSTEM AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED.  A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLE PROGRESSIVE SIGNS OF HEALING.
P960009|S037|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEM|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/06/2006|03/01/2006|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE LABELING WITH RESPECT TO THE MRI (MAGNETIC RESONANCE IMAGING) INSTRUCTIONS; AND FOR REMOVING THE ?MRI AND ACTIVA THERAPY? APPENDIX FROM THE LABELING AND REPLACING IT WITH A STAND-ALONE MRI GUIDELINES DOCUMENT.
P000043|S013|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATIX OFFICE THERMO THERAPY SYSTEM|MEQ|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/07/2006|02/27/2006|||APPR|APPROVAL FOR A REVISION OF CATHETER LABELS AND THE ADDITION OF AN ENHANCED LABEL TO THE EXISTING LABELED STOCK.
P910023|S099|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2006|06/26/2006|||APPR|APPROVAL FOR CHANGES TO THE AUTOMATED TEST SOFTWARE (ATE) USED FOR COMPONENT AND SUBASSEMBLY LEVEL TESTING DURING THE MANUFACTURING PROCESS.
P000057|S003|INTEGRA LIFESCIENCES CORPORATION|8900 CAMERON ROAD||AUSTIN|TX|78754||Finger semi-constrained pyrolytic carbon uncemented prosthesis|ASCENSION MCP|NEG|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/2006|07/17/2006|||APPR|APPROVAL TO ADD A SIZE 05 IMPLANT TO THE PRODUCT LINE.
P000029|S016|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2006|03/01/2006|||APPR|APPROVAL FOR A QUALITY CONTROL CHANGE RESULTING IN ADDITIONAL ASSURANCE OF THE PURITY OF THE DEVICES.
P020045|S015|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS; FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION CATHETERS|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2006|07/05/2006|||APPR|APPROVAL FOR CHANGES IN CLEANING METHODS USED TO REMOVE MANUFACTURING MATERIALS.
P030035|S008|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2006|03/07/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 2.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970013|S005|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2006|03/07/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 2.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P830045|S095|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON AND PHOENIX PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2006|03/07/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 2.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880006|S038|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|REGENCY PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2006|03/07/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 2.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P910023|S100|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|EPIC,EPIC+,ATLAS+, ATLAS, PHOTON MICRO,PHOTON, ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2006|03/07/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 2.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880086|S115|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VARIOUS MODELS OF SYNCHRONY TRILOGY AND AFFINITY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2006|03/07/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 2.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P990040|S002|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2006|03/07/2006|||OK30|CHANGE IN THE IMMEDIATE PRODUCT CONTAINER TO ELIMINATE THE WHITE BACKGROUND PAINT FROM THE ALUMINUM TUBE CONTAINING THE PRODUCT.
P050007|S002|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/2006|01/16/2007|||APPR|APPROVAL FOR CHANGES IN THE LABELING FOR THE DEVICE.
P010014|S008|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2006|03/15/2006|||APPR|APPROVAL FOR A PRODUCT LINE EXTENSION TO INCLUDE A SERIES OF EXTRA-SMALL COMPONENTS (FEMORAL, MENISCAL BEARING, TIBIAL TRAY) AND A NEW SERIES OF ANATOMIC (LEFT AND RIGHT SPECIFIC) MENISCAL BEARING COMPONENTS.
P960004|S034|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|THINLINE/FINELINE ENDOCARDIAL PACING LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2006|03/09/2006|||OK30|USE OF AUTOMATIC VISION SYSTEM FOR INSPECTING THE PRESENCE OF COIL WELD.
P830055|S095|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2006|02/22/2006|||APPR|APPROVAL FOR THE ADDITION OF AN EXTRA INSPECTION STEP THAT IS BEING ADDED TO THE KEMET PROCESS FOR CERTAIN TIBIAL TRAYS IN ORDER TO INSPECT THE PLATFORM THICKNESS PRIOR TO POLISHING.  THE ADDITIONAL INSPECTION IS BEING IMPLEMENTED TO MONITOR THE WEAR OF THE KEMET LAPPING PLATES.
P980016|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2006|03/09/2006|||OK30|ADDITION OF AN IN-PROCESS QUALITY ASSURANCE (QA) TEST TO THE FINAL FUNCTIONAL TESTING.
P010031|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2006|03/09/2006|||OK30|ADDITION OF AN IN-PROCESS QUALITY ASSURANCE (QA) TEST TO THE FINAL FUNCTIONAL TESTING.
P990040|S003|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2006|03/07/2006|||OK30|CHANGE IN THE DRY-HEAT STERILIZER TO ONE OF HIGHER CAPACITY.
P950022|S027|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/10/2006|03/07/2006|||APPR|APPROVAL FOR: 1) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001 AND 7002 ACTIVE-FIXATION DEFIBRILLATION LEADS TO CHANGE THE GEOMETRIC PROFILE OF THE INNER COIL AND ADD WHITE PIGMENT TO THE MEDICAL ADHESIVE USED FOR SHOCK COIL BACKFILL.  2) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 LEADS TO CREATE AN ACTIVE-FIXATION INTEGRATED BIPOLAR LEAD.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7010, 7011, AND 7012 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.  3) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 TO CREATE A PASSIVE FIXATION AND A PASSIVE FIXATION INTEGRATED BIPOLAR LEAD.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7040, 7041 AND 7042 (PASSIVE FIXATION) AND RIATA ST MODELS 7050, 7051, 7052 (PASSIVE FIXATION INTEGRATED BIPOLAR) AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.
P990009|S018|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2006|12/01/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN HAYWARD, CALIFORNIA.
P030032|S005|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|01/27/2006|02/28/2006|||APPR|APPROVAL OF A CLARIFICATION OF THE DEFINITION OF SERIOUS ADVERSE EVENTS.
P990056|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/13/2006|08/10/2006|||APPR|APPROVAL FOR FORMULATION CHANGE TO THE HAMA INTERFERENCE REDUCTION PROTEINS TO IMPROVE ASSAY ROBUSTNESS WITH REGARD TO POTENTIAL HAMA INTERFERENCE FOR THE ELECSYS TOTAL PSA IMMUNOASSAY AND CHANGES IN MATRIX, ANTIGEN AND CALIBRATOR 1 TARGET VALUE FOR THE ELECSYS TOTAL PSA CALSET.  THE ELECSYS TOTAL PSA CALSET, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, ELECSYS TOTAL PSA CALSET II.
P040043|S009|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2006|03/09/2006|||OK30|UPDATING THE VISUAL STANDARD REFERENCED IN THE POST-CRUSH TAG INSPECTION PROCEDURE.
P950022|S028|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/13/2006|03/07/2006|||APPR|APPROVAL FOR: 1) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001 AND 7002 ACTIVE-FIXATION DEFIBRILLATION LEADS TO CHANGE THE GEOMETRIC PROFILE OF THE INNER COIL AND ADD WHITE PIGMENT TO THE MEDICAL ADHESIVE USED FOR SHOCK COIL BACKFILL.  2) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 LEADS TO CREATE AN ACTIVE-FIXATION INTEGRATED BIPOLAR LEAD.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7010, 7011, AND 7012 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.  3) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 TO CREATE A PASSIVE FIXATION AND A PASSIVE FIXATION INTEGRATED BIPOLAR LEAD.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7040, 7041 AND 7042 (PASSIVE FIXATION) AND RIATA ST MODELS 7050, 7051, 7052 (PASSIVE FIXATION INTEGRATED BIPOLAR) AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.
P030022|S002|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2006|06/16/2006|||APPR|APPROVAL FOR MANUFACTURING PROCESS CHANGES TO BE MADE BY CERAMTEC, INC., FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.
P010033|S010|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB GOLD|NCD|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/2006|03/10/2006|||APPR|APPROVAL FOR LABLEING CHANGE TO THE WORDING OF THE INTERPRETATION OF THE TEST TO REMOVE AMBIGUITY AND ENHANCE SAFE USE.
P890003|S100|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS REAL PLUS & BOSS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P820003|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS FAMILIES OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P900061|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P010015|S021|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC/INSYNC II CRT-IPG'S|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P970012|S021|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P010031|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF CRT-ICD'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P850051|S062|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VARIOUS FAMILIES OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P980035|S054|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P930022|S004|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P990001|S025|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P980016|S070|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P980050|S021|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT FAMILY OF ICDS, JEWEL AF|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2006|03/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS.  IT IS TO ENHANCE INTERNAL
P910023|S101|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|EPIC/EPIC+ AND ATLAS/ATLAS+ FAMILY OF PULSE GENERATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2006|03/14/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED SYSTEM FOR THE SOLDERING OF THE OUTPUT FLEX TO FEEDTHRU SUBASSEMBLIES ON THE DEVICE.
P030054|S023|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC II/ EPIC II IMPLANTABLE CARDIOVERTERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P910023|S102|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|SELECTED FAMILIES AND MODELS OF THE ICD'S|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P970013|S006|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P880086|S116|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P900070|S030|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||Pulse generator, permanent, implantable|META AND TEMPO PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/16/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P830045|S096|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON,PHOENIX,MULTILOG AND SENSORITHM PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P820018|S075|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA/QUANDRA,REFLEX,SIMPLEX AND META PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P880006|S039|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|REGENCY,SENSOLOG AND DIALOG PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P030035|S009|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER AND FRONTIER II CRT-P DEVICES|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2006|07/28/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.
P810025|S025|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC AND AMVISC PLUS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2006|03/14/2006|||OK30|REMOVAL OF THE CHLOROFORM TREATMENT STEP FROM THE MANUFACTURING PROCESS FOR THE AMVISC AND AMVISC PLUS.
P030035|S010|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER II DEVICE MODEL 5586|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|03/02/2006|||APPR|APPROVAL FOR A NEW ANALOG CHIP FOR USE IN THE ST. JUDE MEDICAL FRONTIER II DEVICE MODEL 5586.
P830055|S096|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2006|03/22/2006|||APPR|APPROVAL FOR AN ADDITIONAL IN-PROCESS INSPECTION OF THE PATELLA FLANGE THICKNESS FOR THE SIGMA P.F.C. RPF FEMORAL COMPONENTS.
P040002|S004|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOLOGIX POWERLINK STENT GRAFT DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/14/2006|||APPR|APPROVAL FOR TWO NEW BIFURCATED BODY SIZES LISTED AS MODELS 25-16-120BL AND 28-16-120BL.
P000040|S007|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/2006|08/18/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE HTA PROCEDURE SET.
P020022|S004|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2006|03/03/2006|||OK30|CHANGE IN PACKAGING AND LABELING.
P890003|S101|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS& MODEL 2090 PROGRAMMER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/21/2006|||APPR|APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER.  SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
P900061|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM FAMILY MODEL 7227|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/21/2006|||APPR|APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER.  SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
P010015|S022|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/21/2006|||APPR|APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER.  SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
P980050|S022|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT 7276|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/21/2006|||APPR|APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER.  SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
P010031|S038|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF CRT-ICD'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/21/2006|||APPR|APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER.  SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
P000013|S006|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRIDENT CERAMIC ON CERAMIC ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2006|03/14/2006|||OK30|MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC. FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.
P980016|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SELECTED FAMILIES OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/21/2006|||APPR|APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER.  SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
P970012|S022|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 FAMILY|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/21/2006|||APPR|APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER.  SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
P980035|S055|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA/SIGMA/AT500/ENPULSE/ENPULSE II PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2006|04/21/2006|||APPR|APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER.  SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
P010012|S104|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2006|03/24/2006|||OK30|CHANGES TO THE MANUFACTURING TEST SOFTWARE.
P900022|S006|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|CHORUS & OPUS RATE-RESPONSIVE PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2006|03/15/2006|||APPR|APPROVAL FOR THE HARDWARE MODIFICATION OF THE CPR3 PROGRAMMING HEAD TO BE USED WITH ALL THE ELA?S ICD AND PACEMAKER SYSTEMS.
P960013|S017|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|permanent pacemaker Electrode|TENDRILL MODEL 1488T/TC AND 1688T/TC LEADS|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2006|03/02/2006|||OK30|ADDITION OF AN ADDITIONAL CRIMP DEPTH MEASUREMENT AND RECORD ON THE MANUFACTURING TRAVELER DURING PRODUCTION.
P040023|S004|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2006|12/13/2010|||APPR|APPROVAL FOR  MANUFACTURING SITES LOCATED AT:  BIO-VAC, INC., SOUTHFIELD, MICHIGAN; BIO-COAT, INC., SOUTHFIELD; AND ACCELLENT, INC., BRIMFIELD.
P980053|S010|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2006|03/15/2006|||OK30|MODIFICATION TO THE POUCH SEALING PARAMETERS.
P010012|S105|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL FAMILY OF CRT-DS|LWP|CV|30-Day Notice||N|02/23/2006|03/14/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED VISUAL INSPECTION OF DIGITAL DIES.
P900070|S031|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||Pulse generator, permanent, implantable|META AND TEMPO PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2006|03/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC II/EPIC II+ AND EPIC II HF DEVICES.  THE MODIFICATIONS INCLUDE ADDING A VIBRATORY PATIENT NOTIFIER; MODIFYING THE ELECTROGRAM MORPHOLOGY ALGORITHM; MODIFYING THE CAPACITOR MAINTENANCE FEATURE; CHANGING THE MATERIALS OF THE CAN AND HEADER; AND MINOR CHANGES TO PACKAGING AND SOFTWARE.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES EPIC II/EPIC II+ DR/VR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (MODELS V-158, V-255, V-258, AND V-355) AND MODEL 3307 V. 6.0C SOFTWARE. THE MODEL 3307 V. 6.0M SOFTWARE INTERFACES WITH THE ABOVE NOTED PMAS.  THE DEVICES ARE INDICATED AS FOLLOWS:THE EPIC II AND EPIC II+ SYSTEMS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  FOR EPIC II+ DR DEVICES, AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE EPIC II HF SYSTEM IS ALSO INTENDED: 1)TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P800022|S054|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|ZYDERM ZYPLAST COLLAGEN IMPLANT COSMODERM COSMOPLAST HUMAN COLLAGEN IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2006|03/22/2006|||OK30|CHANGE OF COMPONENT SUPPLIER.
P950037|S043|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ACTROS, AXIOS, CYLOC, DROMOS, ERGOS, GEMNOS, KAIROS, KALOS, NANOS, NEOS, PHILOS, PHILOS II, PIKOS, PROTOS, TRIOS, BA03..|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/24/2006|04/24/2006|||APPR|APPROVAL FOR THE ICS 3000 WITH IMPLANT MODULE.
P040013|S002|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENCHANCED MATRIX|NPZ|DE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/27/2006|03/27/2006|||APPR|APPROVAL FOR EXPIRY DATE OF 24 MONTHS AND IS INDICATED TO TREAT THE FOLLOWING PERIODONTALLY RELATED DEFECTS: 1) INTRABONY PERIODONTAL DEFECTS 2) FURCATION PERIODONTAL DEFECTS, AND 3) GINGIVAL RECESSION ASSOCIATED WITH PERIODONTAL DEFECTS.
P030025|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2006|03/29/2006|||OK30|CHANGE TO THE PROCESSING ORDER FOR PRE-LOADING THE STENT PROTECTOR AND THE ADDITION OF AN INSPECTION TO VERIFY THE STENT PROTECTOR OUTER DIAMETER.
P020045|S016|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CCT.2 CRYOABLATION CONSOLE SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/15/2006|06/29/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE PATIENT BOARD IC OF THE CCT.2 CRYOABLATION CONSOLE.
P020045|S017|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS AND FREEZOR XTRA SURGICAL CRYOABLATION CATHETERS & CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2006|04/12/2006|||OK30|CHANGE TO THE INTERNAL QUALITY CONTROL AND INSPECTION PROCESS.
P980022|S015|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS|MDS|CH|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|02/27/2006|03/08/2007|07M-0107|03/26/2007|APPR|APPROVAL FOR THE PARADIGM REAL-TIME AND GUARDIAN REAL-TIME SYSTEMS.  THE GUARDIAN REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, IN ADULTS, AGE 18 AND OVER, AND IN CHILDREN AND ADOLESCENTS, AGE 7 TO 17, WITH DIABETES MELLITUS, FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT.  IT ALERTS IF A GLUCOSE LEVEL FALLS BELOW, OR RISES ABOVE, PRESET VALUES.  VALUES ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR.  THE SYSTEM PROVIDES REAL-TIME GLUCOSE VALUES THAT ALLOW USERS TO TRACK PATTERNS IN GLUCOSE CONCENTRATIONS AND TO POSSIBLY IDENTIFY EPISODES OF LOW AND HIGH BLOOD GLUCOSE.  IT ALSO STORES THE DATA SO THAT IT CAN BE ANALYZED TO TRACK PATTERNS.  GLUCOSE DATA CAN BE FURTHER DOWNLOADED TO PC SOFTWARE FOR ANALYSIS OF HISTORICAL GLUCOSE VALUES.  THE PARADIGM REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, AND POSSIBLE LOW AND HIGH BLOOD GLUCOSE EPISODES IN ADULTS, AGE 18 AND OVER, AND IN CHILDREN AND ADOLESCENTS, AGE 7 THROUGH 17.  THE SYSTEM PROVIDES AN ALERT IF GLUCOSE LEVELS FALL BELOW OR RISE ABOVE PRESET VALUES.  GLUCOSE VALUES PROVIDED BY THE SYSTEM ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED.  ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON SENSOR GLUCOSE READINGS PROVIDED BY THE PARADIGM REAL-TIME SYSTEM.
P880047|S010|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED (TC7) ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/2006|07/03/2006|||APPR|APPROVAL FOR A CHANGE TO THE YARN USED IN THE DEVICE.
P040012|S004|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2006|03/24/2006|||OK30|REDUCING SAMPLING AQL FOR STRAIN RELIEF COMPONENT DIMENSIONAL INSPECTION.
P040012|S005|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2006|03/24/2006|||OK30|CHANGES IMPLEMENTED TO THE PACKAGING MANUFACTURING PROCESS INSTRUCTION (MPI2027943, POUCH/HEADER BAG PACKAGING PROCEDURE).  CHANGES PERTAIN TO THE MANUFACTURING INSPECTION OF POUCH/POUCH SEAL.
P040012|S006|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2006|03/24/2006|||OK30|REMOVAL OF THE OPTION OF USING ISOPROPYL ALCOHOL (IPA) AND A DRY WIPE FOR REMOVING PARTICULATES PRIOR TO LOADING THE STENT ON THE DELIVERY SYSTEM.
P040012|S007|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2006|03/24/2006|||OK30|USE OF NEW TOOLING TO EXPAND THE STENTS DURING THE STENT FABRICATION OPERATION FOR THE OTW AND RX ACCULINK NITINOL STENTS.
P040012|S008|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2006|03/27/2006|||APPR|APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF A NEW CATHETER LEAK TEST TO THE MANUFACTURING PROCESS; 2) MODIFICATIONS TO THE RADIO FORCE IN-PROCESS TESTING PARAMETERS; 3) INCREASING THE STRINGENCY OF THE AQL FOR THE DISTAL JUNCTION TEST; 4) ADDITION OF A MICROSCOPIC VISUAL INSPECTION STEP TO DETECT BROKEN STRUTS; AND 5) ADDITION OF AN INSPECTION STEP TO VERIFY THAT THE ADHESIVE WAS CORRECTLY APPLIED AND COMPLETELY CURED.
P040012|S009|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2006|07/18/2006|||APPR|APPROVAL FOR A MODIFICATION TO A MANUFACTURING PROCESS TO IMPROVE WICKING OF GLUE BETWEEN THE HYPOTUBE AND THE INNER MEMBER AND A MODIFICATION TO THE LOT HISTORY RECORD BILL OF MATERIALS TO ADD A NEW BLOCK FOR DOCUMENTING THE NEW PROCESS.
P040012|S010|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2006|03/14/2006|||APPR|APPROVAL FOR REMOVAL OF STENT MASS AS A FINAL PRODUCT SPECIFICATION FOR THE RX ACCULINK CAROTID STENT SYSTEM AND MODIFICATION OF THE SPECIFICATIONS REGARDING ALLOWABLE CONTAMINANT IN THE DEVICE PACKAGING.
P040012|S011|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2006|03/24/2006|||OK30|CHANGE TO THE DISTAL OUTER MEMBER BONDING PROCEDURE.
P040012|S012|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2006|03/24/2006|||OK30|CHANGE TO MODIFY THE VISUAL INSPECTION CRITERIA FOR THE DISTAL BOND JUNCTION.
P040012|S013|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2006|03/24/2006|||OK30|CHANGE IN THE PROCEDURE FOR VERIFYING STENT OUTER DIAMETER DURING STENT CLEANING PROCESS.
P040012|S014|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2006|03/24/2006|||OK30|CHANGE IN THE TIP BOND PROCEDURE, DELETION OF A REDUNDANT REINSPECTION AND REWORK PROCESS STEP, AND A CHANGE IN THE IN-PROCESS SPECIFICATION FOR THE TIP.
P040001|S002|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM|NQO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2006|08/08/2006|||APPR|APPROVAL FOR THE X STOPPK, A MODIFIED VERSION OF THE X STOP THAT INCLUDES A PEEK SPACER AND ADDITIONAL 16 MM SPACER SIZE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME X STOPPK AND IS INDICATED FOR TREATMENT OF PATIENTS AGED 50 OR OLDER SUFFERING FROM NEUROGENIC INTERMITTENT CLAUDICATION SECONDARY TO A CONFIRMED DIAGNOSIS OF LUMBAR SPINAL STENOSIS (WITH X-RAY, MRI, AND/OR CT EVIDENCE OF THICKENING LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CONAL NARROWING).  THE X STOPPK IS INDICATED  FOR THOSE PATIENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCK/GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND HAVE UNDERGONE A REGIMEN OF AT LEAST 6 MONTHS OF NONOPERATIVE TREATMENT.  THE X STOPPK MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.
P990071|S008|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2006|04/19/2006|||APPR|APPROVAL FOR THE STOCKERT 70 RF GENERATOR INTERFACE WITH THE COOLFLOW IRRIGATION PUMP VIA A CONNECTION CABLE.
P040012|S015|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2006|06/26/2006|||APPR|APPROVAL FOR A MODIFICATION TO THE LOT HISTORY BILL OF MATERIALS TO REMOVE SPECIFIED QUALITY AUDITS THAT ARE NOT NECESSARY OR VALUE ADDED.
P030005|S030|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2006|03/31/2006|||OK30|CHANGE TO THE PLACEMENT REQUIREMENT FOR THE INNER SEAL FOR THE DEVICE.
P010012|S106|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2006|03/31/2006|||OK30|CHANGE TO THE PLACEMENT REQUIREMENT FOR THE INNER SEAL FOR THE DEVICE.
P970003|S065|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|CYBERONICS VNS THERAPY|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2006|10/17/2011|||APPR|APPROVAL FOR LABELING CHANGES RELATED TO THE USE OF MRI SYSTEMS WITH THE DEVICE.
P950032|S043|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/02/2006|04/21/2006|||APPR|APPROVAL FOR A CHANGE IN PRODUCT EXPIRATION DATING FROM 5 DAYS AT 20-37DEGREES C TO 15 DAYS AT 20-23 DEGREES C.
P000043|S014|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATRX TMX-2000 BPH THERMOTHERAPY SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2006|03/28/2006|||APPR|APPROVAL FOR A TRANSFER OF PACKAGING SITE OF THE RECTAL PROBES TO AMERICAN MEDICAL SYSTEMS, MINNETONKA, MINNESOTA AND TO GENERATE PACKAGE LABELS IN HOUSE.
P000049|S016|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|STARFLEX SEPTAL OCCLUSION SYSTEM|MLV|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2006|03/05/2009|||APPR|APPROVAL FOR THE ADDITION OF THE STARFLEX VSD OCCLUDER IN THREE SIZES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARFLEX SEPTAL OCCLUDER AND IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF A SIGNIFICANT SIZE TO WARRANT CLOSURE, BUT THAT BASED ON LOCATION, CANNOT BE CLOSED WITH STANDARD TRANSATRIAL OR TRANSARTERIAL APPROACHES.
P960040|S109|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2006|03/31/2006|||OK30|MOVING THE PROCESS OF APPLYING POLYIMIDE OVER THE BRAZED JOINTS FROM GUIDANT TO THE TELEMETRY COIL SUPPLIER.
P010012|S107|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2006|03/31/2006|||OK30|MOVING THE PROCESS OF APPLYING POLYIMIDE OVER THE BRAZED JOINTS FROM GUIDANT TO THE TELEMETRY COIL SUPPLIER.
P930014|S017|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ MODEL SN60WF POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/02/2006|04/27/2007|||APPR|APPROVAL FOR LABELING CHANGES.
P010012|S108|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2 LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2006|03/24/2006|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER FOR THE CONDUCTOR COIL USED IN THE DEVICE.
P010012|S109|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2006|06/28/2006|||APPR|APPROVAL FOR THE ADDITION OF IN-LINE LAL TESTING (PYROGENICITY TESTING) TO THE INSPECTION PROCEDURE FOR EACH INCOMING LOT RECEIVED AT GUIDANT FOR THE UNIVERSAL FINISHING WIRE ACCESSORIES.
P010012|S110|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|07/28/2006|||APPR|APPROVAL FOR UPDATING THE GOLD BUMPS INCOMING INSPECTION.
P940031|S050|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/MERIDIAN|LWP|CV|135 Review Track For 30-Day Notice||N|03/03/2006|07/28/2006|||APPR|APPROVAL FOR UPDATING THE GOLD BUMPS INCOMING INSPECTION.
P960040|S110|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|135 Review Track For 30-Day Notice||N|03/03/2006|07/28/2006|||APPR|APPROVAL FOR UPDATING THE GOLD BUMPS INCOMING INSPECTION.
P010012|S111|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES.
P010012|S112|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY OF CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|ADDING AN INLINE UNDERFILL PROCESS IN HYBRID MANUFACTURING.
P960040|S111|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VR/PRIZM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES.
P030005|S031|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES.
P940031|S051|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSAR/DISCOVERY/MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES.
P010012|S113|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED SYSTEM FOR INSPECTING THE INNER SEALS PRESENT IN THE DEVICE HEADER.
P010012|S114|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD AND EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|CHANGE TO THE OPERATOR HANDLING/CLEANING INSTRUCTIONS.
P960040|S112|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|CHANGE TO THE OPERATOR HANDLING/CLEANING INSTRUCTIONS.
P860057|S032|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPORSTHESIS MODELS 2700TFX, 2800TFX,3000TFX AND 6900PTFX|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2006|03/24/2006|||APPR|APPROVAL FOR PROTOCOLS TO BE USED TO EXTEND THE SHELF LIFE BEYOND THE CURRENT 2 YEARS.
P970030|S006|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101|LWR|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/2006|03/31/2006|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTION FOR USE TO ADD AND STRENGTHEN CAUTIONS IN THE USE OF THE DEVICE.
P010030|S007|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST (WCD 3100) DEVICE|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2006|11/01/2006|||APPR|APPROVAL FOR HARDWARE CHANGE TO INTEGRATE THE PENDANT ALARM MODULE INTO THE MONITOR ENCLOSURE, HARDWARE CHANGE TO THE COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY TO IMPROVE EMI IMMUNITY AND REPLACE SEVERAL OBSOLETE COMPONENTS, SOFTWARE CHANGES TO INTERACT WITH THE REVISED COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, LABELING CHANGES TO ACCOMMODATE THE INTEGRATED ALARM MODULE, AND TO IMPROVE READABILITY, LABELING CHANGES TO PROVIDE A SPANISH VERSION OF THE PATIENT MANUAL, PATIENT CHECKLIST, AND CORRESPONDING AUDIO/DISPLAY MESSAGES FOR SPANISH SPEAKING PATIENTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3100 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P010012|S115|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES.
P960040|S113|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VR/PRIZM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES.
P030005|S032|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2006|03/31/2006|||OK30|ADDITION OF A REQUIREMENT FOR THE THICKNESS OF THE GOLD PLATING ON THE ACCELEROMETER BOND PAD FOR THE DEVICES.
P000029|S017|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2006|03/28/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT Q-MED AB, UPPSALA, SWEDEN, TO TEST FOR HEAVY METALS AND ANALYSIS OF NITRATES.
P960040|S114|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AND CONTAK CD FAMILIES OF ICDS|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/2006|04/12/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE VENTAK (P960040) AND CONTAK CD (P010012) FAMILIES OF IMPLANTABLE DEFIBRILLATORS TO INCLUDE INFORMATION REGARDING BEHAVIOR OF THESE DEVICES ATTRIBUTABLE TO THE SVO (SILVER VANADIUM OXIDE) USED TO POWER THEM.  SPECIFICALLY, AN UPDATE TO THE SYSTEM GUIDE TO INCLUDE LANGUAGE TO IDENTIFY AS NORMAL AN INCREASED CHARGED TIME IN MIDLIFE DUE TO THE INHERENT CHARACTERISTICS OF THE SVO BATTERIES USED.
P010012|S116|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AND CONTAK CD FAMILIES OF ICDS|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/2006|04/12/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE VENTAK (P960040) AND CONTAK CD (P010012) FAMILIES OF IMPLANTABLE DEFIBRILLATORS TO INCLUDE INFORMATION REGARDING BEHAVIOR OF THESE DEVICES ATTRIBUTABLE TO THE SVO (SILVER VANADIUM OXIDE) USED TO POWER THEM.  SPECIFICALLY, AN UPDATE TO THE SYSTEM GUIDE TO INCLUDE LANGUAGE TO IDENTIFY AS NORMAL AN INCREASED CHARGED TIME IN MIDLIFE DUE TO THE INHERENT CHARACTERISTICS OF THE SVO BATTERIES USED.
P960040|S115|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/2006|04/05/2006|||APPR|APPROVAL FOR UPDATES TO THE SPECIFICATIONS OF THE DEVICES REGARDING CONFIRMATION OF MEETING HERMETIC AND ARC SUPPRESSION UNDER HIGH VOLTAGE REQUIREMENTS RELATED TO THE ATMOSPHERIC GAS WITHIN THE DEVICE.
P010012|S117|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/2006|04/05/2006|||APPR|APPROVAL FOR UPDATES TO THE SPECIFICATIONS OF THE DEVICES REGARDING CONFIRMATION OF MEETING HERMETIC AND ARC SUPPRESSION UNDER HIGH VOLTAGE REQUIREMENTS RELATED TO THE ATMOSPHERIC GAS WITHIN THE DEVICE.
P030054|S024|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF & ATLAS HF CRT-D'S MODEL 3650 MERLIN PATIENT CARE SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2006|04/05/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
P030035|S011|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2006|04/05/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
P970004|S037|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/2006|08/31/2006|||APPR|APPROVAL FOR LABELING CHANGES TO INCORPORATION RESULTS FROM THE FIVE YEAR POST APPROVAL STUDY.
P830045|S097|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PHOENIX AND PARAGON PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2006|04/05/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
P880006|S040|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|REGENCY PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2006|04/05/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
P880086|S117|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SELECTED MODELS OF SYNCHRONY & AFFINITY FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2006|04/05/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
P910023|S103|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|PHOTON, ATLAS/ATLAS+, EPIC/EPIC+, EPIC 2 ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2006|04/05/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
P980022|S016|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL TIME ? MMT-522/722 INSULIN PUMP|MDS|CH|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2006|10/16/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MINIMED PUERTO RICO OPERATIONS, JUNCOS, PUERTO RICO.
P970013|S007|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2006|04/05/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
P030027|S002|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002|0000|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND ARTICULATION SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2006|06/23/2006|||APPR|APPROVAL FOR THE ADDITION OF AN INTERMEDIATE CERAMIC LINER SIZE (36/48G); THREE REPLACEMENT 36MM OD CERAMIC HEADS WITH CONSISTENT OFFSET (-3.5 MM, 0 MM, AND +3.5 MM); AND FEMORAL STEMS AND ACETABULAR SHELLS AS SPECIFIED IN SUBMISSIONS RECEIVED MARCH 8, 2006 AND JUNE 21, 2006 WHICH HAVE BEEN ROUND SUBSTANTIALLY EQUIVALENT VIA THE 510(K) PROCESS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERAMIC LINEAGE/ TRANSCEND ARTICULATION SYSTEM AND IS INDICATED FOR USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.
P000037|S011|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2006|04/07/2006|||OK30|LOWERING THE MINIMUM TOTAL GAS FLOW FOR LEAFLET COATINGS.
P960058|S053|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/2006|03/22/2006|||APPR|APPROVAL FOR A MODIFICATION TO THE ELECTROSTATIC DISCHARGE (ESD) PRECAUTION IN THE HIRESOLUTION BIONIC EAR SYSTEM PACKAGE INSERT.
P010012|S118|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2 LV-1 AND IS-1 LEADS|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2006|06/23/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE AND WARNINGS AS PART OF THE PHYSICIAN MANUALS.
P980023|S021|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|CARDIAC AIRBAG|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/2006|04/24/2006|||APPR|APPROVAL FOR THE ICS 3000 WITH IMPLANT MODULE.
P000009|S017|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS,LEXOS,LUMOS,XELOS DUAL CHAMBER ICD FAMILIES|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/2006|04/24/2006|||APPR|APPROVAL FOR THE ICS 3000 WITH IMPLANT MODULE.
P000018|S042|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH SYSTEM|MOU|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2006|06/16/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE BETA-CATH SYSTEM LABELING, SPECIFICALLY THE INCORPORATION OF THE START/START 40/20 5-YEAR POST-APPROVAL STUDY RESULTS IN THE BETA-CATH INSTRUCTIONS FOR USE.
P030025|S028|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS  EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE)|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/13/2006|09/24/2008|08M-0547|10/15/2008|APPR|APPROVAL FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM ¿ IN-STENT RESTENOSIS (ISR) INDICATION.  THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 TO <=4.00 MM IN DIAMETER IN LESIONS <=28 MM IN LENGTH, AND WITHIN BARE METAL STENT RESTENOTIC LESIONS >=2.25 TO <=3.75 MM IN DIAMETER AND <=28 MM IN LENGTH.
P860004|S082|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/15/2006|03/30/2006|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATION: 1) SHORTENING LENGTH OF BULKHEAD INLET FEATURE BY 0.8 MM (0.03149 INCHES) FROM 3.0 MM TO 2.2 MM; AND 2) INCREASING RADIUS OF OUTER WALL OF BULKHEAD ELECTRONIC CHAMBER POCKET BY 0.3 MM (0.0118 INCHES) FROM 34.5 MM (1.358264 INCHES TO 34.8 MM (1.370075 INCHES).
P000044|S011|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR, AND HBSAG CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2006|04/03/2006|||OK30|ADDITIONAL RAW MATERIAL AND RELEASE TESTS USED IN THE MANUFACTURE OF THE VITROS HBSAG CONFIRMATORY KIT.
P860057|S033|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS MODEL 6900PTFX|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2006|05/18/2006|||APPR|APPROVAL FOR A CLOTH FOLDING MODIFICATION TO THE SEWING RING.
P020014|S012|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/17/2006|06/15/2007|||APPR|APPROVAL FOR DESIGN AND MATERIAL CHANGES TO THE MICRO-INSERT, DELIVERY CATHETER, AND INTRODUCER OF THE ESSURE SYSTEM.
P010012|S119|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL RF|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2006|04/14/2006|||OK30|CHANGE TO THE TEST REQUIREMENT SPECIFICATIONS (TRS) THAT SPECIFIES RADIO FREQUENCY (RF) TESTING FOR CONTAK RENEWAL RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES, AS WELL AS CORRESPONDING TESTING SOFTWARE UPDATES PER ROUTINE PROCEDURES.
P040002|S005|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOLOGIX POWERLINK SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/20/2006|05/17/2006|||APPR|APPROVAL FOR A NEW VERSION OF THE VISIFLEX DELIVERY CATHETER FOR BOTH THE BIFURCATED AND STRAIGHT STENT GRAFTS.
P040028|S001|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD|SUITE 11|SAN DIEGO|CA|92121||Sensor,electro-optical(for cervical cancer)|LUMA CERVICAL IMAGING SYSTEM|MWM|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2006|04/11/2006|||OK30|MODIFICATIONS TO THE INCOMING CAMERA INSPECTION TEST, TEST SOFTWARE USED TO ASSEMBLE THE LUMA SYSTEM AND THE FINAL TEST SOFTWARE USED DURING BURN-IN.
P030017|S012|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM IPG/ETS 3.0|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/22/2006|05/12/2006|||APPR|APPROVAL FOR THE IMPLANTED PULSE GENERATOR (IPG)/EXTERNAL TRIAL STIMULATOR (ETS) FIRMWARE VERSION 3.0.
P960040|S116|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2006|04/21/2006|||OK30|IMPLEMENTATION OF ADDITIONAL PRODUCTS ON EXISTING INNER LEAD BONDING (ILB) MACHINES.
P010012|S120|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2006|04/21/2006|||OK30|IMPLEMENTATION OF ADDITIONAL PRODUCTS ON EXISTING INNER LEAD BONDING (ILB) MACHINES.
P010001|S003|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2006|07/03/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN MARKTREDWITZ, GERMANY.
P030019|S009|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC SODIUM HYALURONATE|MOZ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/2006|10/26/2007|||APPR|APPROVAL FOR MODIFYING THE MANUFACTURING PROCESS FOR ORTHOVISC TO ONE THAT PRODUCES SODIUM HYALURONATE FROM BACTERIAL FERMENTATION.  THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
P980035|S056|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC SIGMA PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2006|04/21/2006|||OK30|REDUCTION OF BURN-IN TIME FOR MEDTRONIC SIGMA DEVICES.
P990038|S011|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS|LOM|MI|Special (Immediate Track)||N|03/24/2006|04/19/2006|||APPR|APPROVAL FOR MANUFACTURING CHANGES IN THE WAY THE POSITIVE CONTROL IS MADE.
P890064|S018|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST|MAQ|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/24/2006|04/28/2006|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLE CONVERSION PROTOCOL FOR SPECIMENS COLLECTED IN PRESERVCYT SOLUTION.  THE MAXIMUM NUMBER OF SPECIMENS THAT CAN BE PROCESSED AT ONE TIME WAS INCREASED FROM 20 TO 36 SPECIMENS.
P970031|S015|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995|LWR|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/2006|08/28/2006|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) BASED ON THE RESULTS OF THE COMPLETED POST-MARKET STUDY FOR THE DEVICE.
P960040|S117|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY AND VITALITY 2 FAMILY MODELS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2006|04/26/2006|||OK30|CHANGES TO THE TEST SOFTWARE.
P010012|S121|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2006|08/09/2006|||APPR|CHANGE TO INCLUDE CIRCUIT BOARD PREPARATION TO THE CLONMEL, IRELAND FACILITY.
P960040|S118|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2006|08/09/2006|||APPR|CHANGE TO INCLUDE CIRCUIT BOARD PREPARATION TO THE CLONMEL, IRELAND FACILITY.
P910077|S058|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MINI FAMILY OF IMPLANTABLE PACEMAKERS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2006|04/26/2006|||OK30|ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.
P940031|S052|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN/DISCOVERY FAMILY OF IMPLANTABLE PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2006|04/26/2006|||OK30|ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.
P960040|S119|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2006|04/26/2006|||OK30|ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.
P010012|S122|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2006|04/26/2006|||OK30|ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.
P030005|S033|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|RENEWAL TR FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2006|04/26/2006|||OK30|ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.
P040024|S006|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|PERLANE INJECTABLE GEL|LMH|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/28/2006|05/02/2007|07M-0180|05/11/2007|APPR|APPROVAL FOR THE PERLANE INJECTABLE GEL.  THE DEVICE IS INDICATED FOR IMPLANTATION INTO THE DEEP DERMIS TO SUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH AS NASOLABIAL FOLDS.
P020002|S002|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP IMAGING SYSTEM|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR SOFTWARE AND LABELING MODIFICATIONS OF THE THINPREP IMAGING SYSTEM FOR REMOTE REVIEWING CAPABILITY & LABELING CHANGE FOR THE THINPREP IMAGING SYSTEM TO INCORPORATE A NEW LIMITATION FOR SPECIMEN REPROCESSING.
P910061|S013|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|07/20/2006|||APPR|APPROVAL FOR LABELING CHANGES FOR THE ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS AND IS INDICATED TO BE USED FOR PRIMARY IMPLANTATION FOR THE CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION METHODS.  THE LENS IS INTENDED FOR PLACEMENT IN THE CILIARY SULCUS OR CAPSULAR BAG.
P930016|S024|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|05/03/2006|||APPR|APPROVAL FOR WAVESCAN SYSTEM SOFTWARE VERSION 3.70 CONTAINING MINOR DESIGN (USER INTERFACE AND STREAMLINED ACQUISITION  AND TREATMENT PLANNING MODE) AND LABELING CHANGES.
P030054|S025|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF & EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.1M SOFTWARE|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P880086|S118|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SOLUS,ADDVENT,SOLUS II,SYNCHRONY, PHOENIX III, TRIOLOGY, AFFINITY, INTEGRITY, ENTITY,IDENTITY, VERITY, AND VICTORY PACEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P970013|S008|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P030035|S012|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P880006|S041|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|REGENCY, SENSOLOG III, AND DIALOG II PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P820018|S076|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AURORA/QUANDRA, REFLEX, SIMPLEX, AND META PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P830045|S098|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON, PHOENIX, MULTILOG AND SENSORITHM PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P900070|S032|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||Pulse generator, permanent, implantable|META AND TEMPO PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P910023|S104|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|EPIC II, EPIC II+, EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILATORS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2006|04/28/2006|||APPR|APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
P810002|S059|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2006|05/11/2006|||APPR|APPROVAL FOR CHANGES TO THE PHYSICIANS MANUAL (IFU) AND PATIENT ID CARD FOR THE ABOVE LISTED MODELS.
P010012|S123|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE INTRA-CARDIAC DEFIBRILLATOR (ICD)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2006|04/26/2006|||OK30|UPDATES TO THE TEST SOFTWARE AND TEST HARDWARE.
P000032|S018|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2006|05/23/2006|||APPR|APPROVAL FOR A CHANGE IN THE JOINING PROCESS OF THE HEATER AND THERMOCOUPLE WIRES TO THE DISPOSABLE TIP.
P960040|S120|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL  CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2006|04/26/2006|||OK30|UPDATES TO THE TEST SOFTWARE AND TEST HARDWARE.
P850020|S022|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||Separator for therapeutic purposes, membrane automated blood cell/plasma|PROSORBA COLUMN|MDP|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2006|06/22/2006|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE HAEMONETICS MCS AND HAEMONETICS MCS+ PLASMAPHERESIS SYSTEMS IN CONJUNCTION WITH THE PROSORBA COLUMN.
P910061|S014|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/03/2006|08/28/2008|||APPR|APPROVAL FOR USE OF THE EASY LOAD LENS RETAINER FOR PACKAGING THE LI61AO LENS.
P020026|S017|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|RAPTORRAIL RX SDS, 2.25MM CYPHER STENT|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/2006|09/18/2009|||APPR|APPROVAL FOR THE 2.25 MM CYPHER STENT ON RAPTORRAIL RX STENT DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CYPHER AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS OF LENGTH <= 30 MM IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER OF >=2.25 TO <=3.50 MM.
P030044|S002|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, epidermal growth factor receptor|DAKO EGFR PHARMDX KIT|NQF|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/2006|09/27/2006|||APPR|APPROVAL FOR ADDING A NEW THERAPY VECTIBIX (PANITUMUMAB) TO INTENDED USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DAKO EGFR PHARMDX KIT AND IS INDICATED FOR: THE EGFR PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM TO IDENTIFY EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXPRESSION IN NORMAL AND NEOPLATIC TISSUES ROUTINELY-FIXED FOR HISTOLOGICAL EVALUATIN.  EGFR PHARMDX SPECIFICALLY DETECTS THE EGFR (HER1) PROTEIN IN EGFR-EXPRESSING CELLS.  EGFR PHARMDX IS INDICATED AS AN AID IN IDENTIFYING COLORECTAL CANCER PATIENTS ELIGIBLE FOR TREATMENT WITH ERBITUX (CETUXIMAB), OR VECTIBIX (PANITUMUMAB).
P030039|S004|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT (PREMIXED)|NBE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/2006|05/11/2007|||APPR|APPROVAL FOR THE ADDITION OF THE COSEAL SPRAY DELIVERY SYSTEM WITH A SPRAY SET AND PRESSURE REGULATOR.
P890003|S102|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DDMA DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2006|08/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DMA SOFTWARE TO SUPPORT THE CONCERTO CRT-D AND VIRTUOSO ICD DEVICES.
P040044|S001|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Panel Track|Change Design/Components/Specifications/Material|N|04/06/2006|05/16/2007|07M-0285|07/20/2007|APPR|APPROVAL FOR THE MYNX VASCULAR CLOSURE SYSTEM.  THE DEVICE IS INDICTED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F, OR 7F PROCEDURAL SHEATH.
P020026|S018|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2006|05/18/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CORDIS DE MEXICO, CHIHUAHUA, MEXICO TO MANUFACTURE THE OVER-THE-WIRE STENT DELIVERY SYSTEM (SDS).
P960016|S016|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/07/2006|04/21/2006|||APPR|APPROVAL FOR THE ADDITION OF THE IBI 1500T6 RF GENERATOR EXTENSION CABLES.
P890003|S103|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS, REAL PLUS & BOSS REVEAL PLUS PREVA FAMILY, VITATRON VISA, VITATRON LEGACY FAMILY, THERA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2006|05/08/2006|||APPR|APPROVAL FOR THE ADDITION OF THE SUPPORT FOR THE INSYNC III MARQUIS TO THE 2490G CARELINK MONITOR AND THE 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE, AND THE UPDATES TO THE FIRMWARE USED IN THE 2490G CARELINK MONITOR AND UPDATES TO THE 2491 DDMA SOFTWARE.
P900061|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 720|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2006|05/08/2006|||APPR|APPROVAL FOR THE ADDITION OF THE SUPPORT FOR THE INSYNC III MARQUIS TO THE 2490G CARELINK MONITOR AND THE 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE, AND THE UPDATES TO THE FIRMWARE USED IN THE 2490G CARELINK MONITOR AND UPDATES TO THE 2491 DDMA SOFTWARE.
P980016|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SELECTED FAMILIES OF ICD'S, ENTRUST FAMILY,INTRINSIC FAMILY,ONYX, MAXIMO FAMILY, MARQUIS FAMILY,GEM III FAMILY,GEM II FA|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2006|05/08/2006|||APPR|APPROVAL FOR THE ADDITION OF THE SUPPORT FOR THE INSYNC III MARQUIS TO THE 2490G CARELINK MONITOR AND THE 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE, AND THE UPDATES TO THE FIRMWARE USED IN THE 2490G CARELINK MONITOR AND UPDATES TO THE 2491 DDMA SOFTWARE.
P010031|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF CRT-ICD'S, INSYNC MAXIMO, INSYNC SENTRY FAMILY, INSYNC II PROTECT, INSYNC III MARQUIS FAMILY, INSYNC|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2006|05/08/2006|||APPR|APPROVAL FOR THE ADDITION OF THE SUPPORT FOR THE INSYNC III MARQUIS TO THE 2490G CARELINK MONITOR AND THE 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE, AND THE UPDATES TO THE FIRMWARE USED IN THE 2490G CARELINK MONITOR AND UPDATES TO THE 2491 DDMA SOFTWARE.
P980022|S017|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2006|06/14/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE MONITOR AND TRANSMITTER OF THE PREVIOUSLY APPROVED GUARDIAN RT SYSTEM.  THE REAL-TIME MONITOR HAS A LARGER LCD FOR EASE OF VIEWING FOR THE USER AND TO SUPPORT GRAPHICAL DISPLAY OF THE DATA.  ALSO, IN THE REAL-TIME MONITOR, RF COMMUNICATION IS RECEIVED FROM THE TRANSMITTER AT 916.35 MHZ, WHICH IS THE IDENTICAL FREQUENCY USED IN THE PARADIGM MODEL MMT-515/715 INSULIN PUMPS (CLEARED UNDER K040676).  IN ADDITION, THE METER READINGS FOR CALIBRATION CAN BE MANUALLY ENTERED, IDENTICAL TO THE GUARDIAN RT, OR AUTOMATICALLY, VIA TELEMETRY, WHEN USING THE PARADIGM LINK METER IN THE IDENTICAL SCHEME AS IN THE PREVIOUSLY CLEARED INSULIN PUMP.  THE CALIBRATION ALGORITHM AND GLUCOSE VALUES REPORTED BY THE SYSTEM ARE IDENTICAL BETWEEN THE GUARDIAN RT SYSTEM AND THE GUARDIAN REAL-TIME SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, IN ADULTS (AGES 18 AND OLDER) WITH DIABETES MELLITUS, FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT.  IT ALERTS IF A GLUCOSE LEVEL FALLS BELOW OR RISES ABOVE, PRESET VALUES.  VALUES ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGER STICK MAY BE REQUIRED.  ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE METER AND NOT ON GUARDIAN REAL-TIME CGM SYSTEM VALUES.  THE GUARDIAN REAL-TIME CGM SYSTEM PROVIDES REAL-TIME GLUCOSE VALUES THAT ALLOW USERS TO TRACK PATTERNS IN GLUCOSE CONCENTRATIONS AND TO POSSIBLY IDENTIFY EPISODES OF LOW AND HIGH BLOOD GLUCOSE.  IT ALSO STORES THE DATA SO THAT IT CAN BE ANALYZED TO TRACK PATTERNS.  GLUCOSE DATA CAN BE FURTHER DOWNLOADED TO PC SOFTWARE FOR ANALYSIS OF HISTORICAL VALUES.
P950037|S044|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2006|02/15/2007|||APPR|APPROVAL FOR CHANGES TO THE BLISTER PACKAGE AND OUTER SALES BOX.
P980023|S022|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|BIOTRONIK PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2006|02/15/2007|||APPR|APPROVAL FOR CHANGES TO THE BLISTER PACKAGE AND OUTER SALES BOX.
P000009|S018|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KAINOX A+ ICD LEAD|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2006|02/15/2007|||APPR|APPROVAL FOR CHANGES TO THE BLISTER PACKAGE AND OUTER SALES BOX.
P970038|S008|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2006|05/18/2006|||APPR|APPROVAL FOR THE ACCESS PSA REAGENTS FOR USE ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCESS FREE PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM.
P980041|S008|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2006|05/16/2006|||APPR|APPROVAL FOR THE ACCESS AFP REAGENTS FOR USE ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS.  THE ACCESS AFP ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR USE WITH THE ACCESS IMMUNOASSAY SYSTEMS FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER.  2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO 20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD).  TEST RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD.  THE ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY.
P850048|S020|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2006|05/18/2006|||APPR|APPROVAL FOR THE ACCESS PSA REAGENTS FOR USE ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCESS PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM.
P030017|S013|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2006|12/21/2006|||APPR|APPROVAL TO ADD AN ALTERNATE STERILIZATION CYCLE.
P980016|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DMA SOFTWARE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2006|08/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DMA SOFTWARE TO SUPPORT THE CONCERTO CRT-D AND VIRTUOSO ICD DEVICES.
P010031|S040|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO MODEL C154DWK|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2006|08/31/2006|||APPR|APPROVAL FOR THE MEDTRONIC CARELINK MONITOR MODEL 2490C AND MODEL 2491 DMA SOFTWARE TO SUPPORT THE CONCERTO CRT-D AND VIRTUOSO ICD DEVICES.
P930021|S009|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN|NQA|DE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/2006|04/24/2006|||APPR|APPROVAL FOR THE ADDITION OF POST-MARKET EXPERIENCE INFORMATION TO THE WARNING SECTION OF THE EMDOGAIN PACKAGE INSERT.
P040013|S003|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2006|09/22/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT NOVARTIS CORPORATION, VACAVILLE, CALIFORNIA.
P960013|S018|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL ST LEAD MODELS 1888TC AND 1882TC|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2006|06/06/2006|||APPR|APPROVAL TO MODIFY THE LEAD INSULATION ON THE TENDRIL ST 1788T/TC AND TENDRIL ST 1782 LEADS, AND TO REDUCE THE OUTER COIL WIRE DIAMETER ON THE TENDRIL ST 1782 LEAD.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST LEAD MODEL 1888TC AND TENDRIL ST LEAD MODEL 1882TC.  THE TENDRIL ST LEAD MODEL 1888TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.  THE TENDRIL ST LEAD MODEL 1882TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
P810031|S027|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON,HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2006|08/28/2006|||APPR|APPROVAL FOR A NEW SECONDARY PACKAGING CONFIGURATION FOR THE HEALON, HEALONGV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES.
P970051|S037|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2006|05/25/2006|||APPR|APPROVAL FOR 1) SMALLER AND MORE COSMETIC, EAR-LEVEL CONTROLLER (POWERED BY TWO 675 HEARING-AID BATTERIES) AND 2) A RECHARGEABLE LITHIUM-ION BATTERY ? BOTH FOR USE WITH THE MODULAR NUCLEUS FREEDOM SPEECH PROCESSOR.
P030025|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/01/2006|||OK30|ELIMINATION OF THE FINAL FUNCTIONAL AUDITS (FFA).
P010012|S125|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P030025|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/01/2006|||OK30|MODIFICATION OF THE EQUIPMENT NOZZLE TO THE MOLD USED FOR MAKING THE MANIFOLD.
P040016|S009|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/01/2006|||OK30|MODIFICATION OF THE EQUIPMENT NOZZLE TO THE MOLD USED FOR MAKING THE MANIFOLD.
P010012|S126|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL CD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P030005|S034|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P830060|S059|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P910073|S064|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK/ENDURANCE/RELIANCE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P910077|S059|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX/MINI I-IV|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P930035|S015|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P940008|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P950001|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P960004|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|THINLINE/FINELINE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P830060|S060|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P960006|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX/FLEXTEND|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P910073|S065|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P910077|S060|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PR/ VENTAK MINI|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P960040|S121|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VR/PRIZM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/11/2006|||OK30|CHANGES TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN.
P930035|S016|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P940008|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P940031|S053|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P950001|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P960004|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|THINLINE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P960006|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P960040|S122|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2006|05/12/2006|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLAN.
P910001|S025|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12|LPC|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2006|08/02/2006|||APPR|APPROVAL FOR A NEW SOFTWARE VERSION TO THE CVX-3000 EXCIMER LASER AND REVISED LABELING TO THE LASER CONSOLE.
P960042|S009|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12|MFA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2006|08/02/2006|||APPR|APPROVAL FOR A NEW SOFTWARE VERSION TO THE CVX-3000 EXCIMER LASER AND REVISED LABELING TO THE LASER CONSOLE.
P030017|S014|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/14/2006|05/24/2006|||APPR|APPROVAL FOR THE CHARGER 2.0.
P850020|S023|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||Separator for therapeutic purposes, membrane automated blood cell/plasma|PROSORBA COLUMN|MDP|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/2006|05/11/2006|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE COBE SPECTRA APHERESIS SYSTEM AND THE FRESENIUS AS104 SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.
P790017|S085|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|MEDTRONIC VASCULAR NC STORMER MX2 BALLON DILATATION CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2006|05/12/2006|||APPR|APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE (IFU) IN ORDER TO ENHANCE THE SAFETY OF THE DEVICE AND AVOID THE GUIDEWIRE EXITING THE GUIDE WAY OF THE CATHETER.
P990066|S023|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE DS FFDM SYSTEM|MUE|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2006|05/05/2006|||APPR|APPROVAL TO CORRECT A SCALE RULE ANNOTATION ON PRINTED DIGITAL MAMMOGRAPHY IMAGES AND CORRESPONDING LABELING CHANGES TO THE OPERATOR INSTRUCTIONS.
P860057|S034|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2006|05/12/2006|||OK30|CHANGE IN WIREFORMING FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS, AND INTRODUCTION OF A CLEANING METHOD TO REMOVE LUBRICANT WITH SOLVENT.
P970003|S066|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2006|06/08/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 250 PROGRAMMING SOFTWARE VERSION 7.1.
P910077|S061|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/2006|08/08/2006|||APPR|LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3.
P990064|S015|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2006|08/25/2006|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) BASED ON THE RESULTS OF THE COMPLETED POST-MARKET STUDY OF THE DEVICE.
P000025|S020|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2006|05/31/2006|||APPR|APPROVAL FOR NEW DIAGNOSTIC INTERFACE BOX II (DIB II).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIB II AND IS INTENDED TO OFFER THE CLINICIAN TOOLS FOR DIFFERENT CLINICAL APPLICATIONS WITH THE MED-EL COCHLEAR IMPLANT SYSTEM.
P030022|S003|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2006|08/14/2007|||APPR|APPROVAL FOR A CHANGE TO THE POROUS COATING PROCESS FOR THE REFLECTION CERAMIC ACETABULAR SHELL TEST COUPON.
P030022|S004|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2006|05/04/2007|||APPR|APPROVAL OR THE ADDITION OF ANOTHER ETO STERILIZATION PROCESS THAT UTILIZES A 4 HOUR EO EXPOSURE TIME COMPARED TO THE PREVIOUS 2 HOUR EO EXPOSURE TIME, AS WELL AS A CHANGE IN THE ACCEPTABLE NUMBER OF BIOINDICATORS TO REFLECT CURRENT AAMI STANDARDS.
P970051|S038|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2006|06/14/2006|||APPR|APPROVAL FOR 1) VERSION 1.3 OF THE CUSTOM SOUND PROGRAMMING SOFTWARE WHICH INCLUDES SOFTWARE MODIFICATIONS AND ENHANCEMENTS WHICH WILL ENABLE RECIPIENTS OF THE PREVIOUS GENERATION NUCLEUS 24 COCHLEAR IMPLANTS TO USE THE LATEST APPROVED FREEDOM SPEECH PROCESSOR, AND 2) FREEDOM PROCESSOR FIRMWARE CHANGES RELATED TO THE PROCESSORS LIQUID-CRYSTAL DISPLAY (LCD).
P800036|S036|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track No User Fee|Express GMP Supplement|N|04/21/2006|06/23/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE AT CODMAN & SHURTLEFF, INC.RAYNHAM, MASSACHUSETTS.
P000028|S008|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Intervertebral fusion device with bone graft, lumbar|AFFINITY ANTERIOR CERVICAL CAGE SYSTEM|MAX|OR|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/2006|07/25/2006|||APPR|APPROVAL FOR CHANGES TO THE DEVICE LABELING TO INCORPORATE DATA COLLECTED FROM THE POST MARKET STUDY OF THE DEVICE.
P910018|S011|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/2006|06/27/2007|||APPR|APPROVAL TO USE THE SULFLUX KP-05 PLASMA SEPARATOR AS A COMPONENT OF THE LIPOSORBER LA-15 SYSTEM.
P860019|S208|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/2006|11/07/2008|||APPR|APPROVAL FOR THE APEX MONORAIL AND OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS.  THE DEVICE, AS MODIFIED, IS INDICATED FOR: 1) (BALLOON MODELS 1.5 ¿ 5.0 MM) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; AND 2) (BALLOON MODELS 2.0 ¿ 5.0 MM) FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P910023|S107|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE, CADET, CANTOUR, ANGSTROM, PROFILE,PHOTON, EPIC AND ATLAS ICD FAMILIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2006|05/23/2006|||OK30|USE OF AN ALTERNATE ENCAPSULANT MATERIAL IN ICD/CRT-D HYBRID PRODUCTION.
P030054|S028|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF AND ATLAS + HF CRT-D FAMILIES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2006|05/23/2006|||OK30|USE OF AN ALTERNATE ENCAPSULANT MATERIAL IN ICD/CRT-D HYBRID PRODUCTION.
P020016|S001|BIOMET MICROFIXATION, INC.|1520 TRADEPORT DR.||JACKSONVILLE|FL|32218||Joint, temporomandibular, implant|TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM|LZD|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2006|05/26/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WALTER LORENZ SURGICAL, INC.S JACKSONVILLE, FLORIDA FACILITY FOR THE WIRE ELECTRICAL DISCHARGE MACHINING MANUFACTURING PROCESS.
P990040|S004|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM|KGG|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/28/2006|06/01/2006|||APPR|APPROVAL FOR REVISIONS TO THE PRODUCT LABEL REGARDING USE OF THE PRODUCT UNDER HIGH FLOW CONDITIONS, AND WITH RATIOS OF CONTRAST REAGENT AND NBCA OUTSIDE OF THOSE RATIOS TESTED IN THE CLINICAL STUDY.
P900009|S023|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 2000+ BONE HEALING SYSTEM|LPQ|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2006|06/30/2006|||APPR|APPROVAL FOR THE INCORPORATION OF A DRI-SHIELD 2000 MOISTURE BARRIER BAG (ELECTROSTATIC DISCHARGE [ESD] BAG) AS PART OF THE DEVICE PACKAGING.
P020018|S009|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2006|06/01/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT ANCILLARY COMPONENT LABELING TO CLARIFY THE LENGTH LIMITATIONS FOR USE OF THE 58 MM LENGTH MAIN BODY EXTENSION WHEN USED IN CONJUNCTION WITH THE SHORTEST ZENITH MAIN BODY COMPONENTS.
P040042|S002|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/01/2006|06/27/2006|||APPR|APPROVAL FOR A SOFTWARE MODIFICATION THAT ALLOWS THE ELIMINATION OF A MINOR DELAY IN GRAPHICAL RECORDING AND DISPLAYING TIME.
P860004|S083|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED AND ISOMED IMPLANTABLE INFUSION PUMPS: MEDTRONIC MODEL 8840 N?VISION PROGRAMMING SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|05/01/2006|07/05/2006|||APPR|APPROVAL FOR CHANGES TO THE PLATFORM SOFTWARE ON THE MODEL 8840 N'VISION PROGRAMMING SYSTEM.
P040023|S006|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2006|09/20/2006|||APPR|APPROVAL FOR A CHANG IN THE ORDER OF THE MANUFACTURING STEPS, THE ADDITION OF A NEW IN-PROCESS TEST, AND THE ADDITION OF A REDUNDANT IN-PROCESS TEST.
P010012|S128|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL RF CRT-D FAMILY OF DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2006|06/01/2006|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE UNFILTERED FEEDTHRU USED IN THE DEVICE.
P940031|S054|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN, MODELS 976,1176, 1276|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2006|09/15/2006|||APPR|APPROVAL OF THE AUTOMATION OF A QUERY REVIEW PROCESS AND THE ADDITION OF AN AUTOMATED RELEASE AND SIGNOFF STEP.
P010012|S129|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2006|09/15/2006|||APPR|APPROVAL OF THE AUTOMATION OF A QUERY REVIEW PROCESS AND THE ADDITION OF AN AUTOMATED RELEASE AND SIGNOFF STEP.
P960040|S125|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-D)|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2006|09/15/2006|||APPR|APPROVAL OF THE AUTOMATION OF A QUERY REVIEW PROCESS AND THE ADDITION OF AN AUTOMATED RELEASE AND SIGNOFF STEP.
P040023|S007|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/04/2006|05/26/2006|||APPR|APPROVAL FOR AN ADDITIONAL LABEL BEING ADDED TO THE DEVICE OUTER PACKAGE THAT STATES, "WARNING: ONLY COMPATIBLE WITH OPTION SERIES IMPLANTS".
P960040|S126|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK AND RENEWAL FAMILIES|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/05/2006|08/08/2006|||APPR|LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3.
P010012|S130|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM AND VITALITY FAMILIES|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/05/2006|08/08/2006|||APPR|LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3.
P990081|S003|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY|MVC|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/04/2006|01/11/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE PATHWAY C-ERBB-2 PRIMARY ANTIBODY(CLONE CB11) WHICH INCLUDE 1) CHANGE THE PRIMARY ANTIBODY FROM THE MOUSE MONOCLONAL ANTIBODY CB11 TO THE RABBIT MONOCLONAL ANTIBODY 4B5, 2) CHANGE THE DETECTION FORMAT FROM BASIC DAB DETECTION KIT TO THE VENTANA MEDICAL SYSTEMS IVIEW DAB DETECTION KIT, 3) ADD THE OPTIONAL ULTRAVIEW UNIVERSAL DAB DETECTION KIT FOR BIOTIN FREE DETECTION FORMAT, 4) CONSOLIDATE LEVEL 1,3 AND NEGATIVE HER-2 ASSAY CONTROL SLIDES ONTO A SINGLE SLIDE AND ADD A LEVEL 2 ASSAY CONTROL AND THE CONTROL WILL BE MARKETED UNDER THE TRADE NAME OF PATHWAY HER2 4 IN 1 CONTROL SLIDE, AND 5) INCLUDE THE VENTANA IMAGE ANALYSIS SYSTEM (VIAS) IN THE LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY AND IS INDICATED FOR: VENTANA MEDICAL SYSTEMS, INC.?S (VENTANA) PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY (PATHWAY HER2 (4B5)) IS A RABBIT MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF HER2 ANTIGEN IN SECTIONS OF FORMALIN-FIXED, PARAFFIN-EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEMISTRY SLIDE STAINING DEVICE.  IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN TREATMENT IS BEING CONSIDERED.
P860004|S084|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/08/2006|06/09/2006|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 8840 N VISION PROGRAMMER GUIDE REGARDING THE REPOSITIONING AND REPEATING OF AN EXISTING WARNING.
P910023|S108|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ICDS/CRT-DS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|CHIP MODIFICATIONS AND A YIELD IMPROVEMENT AT THE CHIP SUPPLIER.
P030054|S029|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ICDS/CRT-DS|NIK|CV|30-Day Notice||N|05/09/2006|06/08/2006|||OK30|CHIP MODIFICATIONS AND A YIELD IMPROVEMENT AT THE CHIP SUPPLIER.
P910023|S109|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/09/2006|06/20/2006|||APPR|APPROVAL FOR THE ENHANCEMENTS TO THE DATA PROCESSING USED FOR THE ST. JUDE MEDICAL HOUSECALL PLUS SYSTEM.
P860019|S209|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA/ PERFUSION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P900056|S088|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM WIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P930031|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPORSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P940019|S020|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ILIAC ENDOPORSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P950020|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P980033|S014|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P020009|S026|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P030025|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P040016|S010|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2006|06/08/2006|||OK30|ADDITION OF AN ALTERNATIVE BIOLOGICAL INDICATOR (BI).
P960040|S127|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY 2, VITALITY AVT, VITALITY DS, VITALITY EL, VITALITY HE|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/2006|08/25/2006|||APPR|APPROVAL FOR PRODUCT RELIABILITY TEST TO BE ADDED TO THE PHYSICIAN AND PATIENT LABELING AS WELL AS OTHER MINOR CHANGES TO THE PATIENT MANUALS.
P940031|S055|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISCOVERY/ MERIDIAN|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/2006|08/25/2006|||APPR|APPROVAL FOR PRODUCT RELIABILITY TEST TO BE ADDED TO THE PHYSICIAN AND PATIENT LABELING AS WELL AS OTHER MINOR CHANGES TO THE PATIENT MANUALS.
P030005|S035|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK TR CARDIAC RESYNCHRONIZATION THERAPY SYSTEMS|NKE|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/2006|08/25/2006|||APPR|APPROVAL FOR PRODUCT RELIABILITY TEST TO BE ADDED TO THE PHYSICIAN AND PATIENT LABELING AS WELL AS OTHER MINOR CHANGES TO THE PATIENT MANUALS.
P010012|S131|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/12/2006|08/25/2006|||APPR|APPROVAL FOR PRODUCT RELIABILITY TEST TO BE ADDED TO THE PHYSICIAN AND PATIENT LABELING AS WELL AS OTHER MINOR CHANGES TO THE PATIENT MANUALS.
P000032|S019|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION  CRYOABLATION THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2006|07/28/2006|||APPR|APPROVAL FOR AN ADDITION OF A TEST FIXTURE TO AUTOMATE THE INSPECTION OF THE HER OPTION CRYOABLATION DISPOSABLE PROBE.
P000044|S012|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR &  PRODUCTS HBSAG CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2006|06/05/2006|||OK30|ADDITION OF A SPECIFICATION FOR RAW MATERIAL.
P000014|S014|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2006|06/05/2006|||OK30|ADDITION OF A SPECIFICATION FOR RAW MATERIAL.
P840001|S092|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE ADVANCED & PRIME ADVANCED NEUROSTIMULATIONS SYSTEMS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/12/2006|07/07/2006|||APPR|APPROVAL FOR THE RESTOREADVANCED AND PRIME ADVANCED NEUROSTIMULATION SYSTEMS.  THE DEVICES ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 6) PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS; 8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK SURGERIES.
P040022|S001|Medtronic Vascular|37A Cherry Hill Drive||Danvers|MA|01923||Device, hemostasis, vascular|ANGIOLINK VASCULAR CLOSURE SYSTEM|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2006|10/02/2006|||APPR|APPROVAL FOR VARIOUS MANUFACTURING PROCESS CHANGES TO ENSURE CONSISTENCY.
P040024|S007|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2006|06/23/2006|||OK30|CHANGES TO FOUR INTERNAL PROCESSING FUNCTIONS.
P960013|S019|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL ST MODEL 1788T/TC & 1782 LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2006|06/13/2006|||OK30|CHANGE TO THE INNER CRIMP CORE MATERIAL.
P030024|S005|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2006|06/05/2006|||OK30|ADDITION OF A SPECIFICATION FOR THREE DIFFERENT RAW MATERIALS.
P880086|S121|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ST JUDE MEDICAL PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2006|06/08/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS TO REMOVE HYDROHONE BEADS AND AIR DRY THE PACEMAKERS FOLLOWING THIS HYDROHONING PROCESS, WHICH WILL BE PERFORMED USING THE CYCLONE WASH-DRY MACHINE.
P990065|S004|SIRTEX MEDICAL LIMITED|UNIT F6 PARKVIEW 16 MARS ROAD||LANE COVE||NSW 2||Microspheres radionuclide|SIR-SPHERES|NAW|RA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|05/15/2006|01/18/2008|||APPR|APPROVAL FOR A MANUFACTURING AND STERILIZATION SITE LOCATED IN WILMINGTON, MASSACHUSETTS.
P030035|S015|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER & FRONTIER II PACEMAKERS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2006|06/08/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS TO REMOVE HYDROHONE BEADS AND AIR DRY THE PACEMAKERS FOLLOWING THIS HYDROHONING PROCESS, WHICH WILL BE PERFORMED USING THE CYCLONE WASH-DRY MACHINE.
P830055|S097|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2006|06/15/2007|||APPR|APPROVAL FOR CHANGING FROM A MANUAL TO AN AUTOMATED TIE BAR CUT OFF FOR THE LCS FEMORAL CASTINGS.
P000040|S008|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION  SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2006|06/23/2006|||APPR|APPROVAL FOR 1) ADDITION OF THE LINEAR FLASH CARD MEMORY TO THE CENTRAL PROCESSING BOARD; 2) TEMPERATURE CONTROLLER PID SETTINGS/INCREASE IN CYCLE TIME PROGRAMMED INTO HEATER LOGIC AND CONTROLLER BOARD; AND 3) ADDITION OF COMPONENTS TO THE LEVEL SENSOR BOARD.
P890003|S104|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|LEGACY D, LEGACY S, LEGACY II, VISA, CAPSURE PACING LEADS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P920015|S035|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT LEADS, TUNNELING TOOLS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P900061|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) GEM|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P980016|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P980035|S057|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700, VITATRON, KAPPA 900, ENPULSE, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM, AT500|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P010015|S023|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III, INSYNC, ATTAIN|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P850089|S054|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE PACING LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P950024|S008|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P970012|S023|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P010031|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS MODELS OF INSYNC ICDS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P980050|S023|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT ICD & TRANSVENE LEAD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P030036|S001|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC SELECTSECURE LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P990025|S012|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/14/2006|10/06/2006|||APPR|APPROVAL FOR USING A NEW HANDLE, PULLER WIRES AND 1 MM LOCATION SENSOR.
P790018|S046|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2006|11/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P840001|S093|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE ADVANCED, PRIME ADVANCED, RESTORE PRIME, RESTORE, SYNERGY PLUS, SYNERGY COMPACT+, SYNERGY|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2006|07/18/2006|||APPR|APPROVAL FOR CHANGES TO THE PLATFORM SOFTWARE ON THE MODEL 8840 N'VISION PROGRAMMING SYSTEM.
P020045|S019|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX CARDIAC CRYOABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2006|06/13/2006|||OK30|ADHESIVE CHANGE.
P970004|S039|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FOR  URINARY CONTROL|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2006|06/27/2006|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MODEL 8840 N'VISION PROGRAMMING SYSTEM.
P960009|S039|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PARKINSONS CONTROL THERAPY|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2006|07/27/2006|||APPR|APPROVAL FOR CHANGES TO THE PLATFORM SOFTWARE ON THE MODEL 8840 N'VISION PROGRAMMING SYSTEM.
P920047|S034|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER RF ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2006|06/13/2006|||OK30|ADDITION OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) SUPPLIER.
P020025|S017|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER XP RF ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2006|06/13/2006|||OK30|ADDITION OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) SUPPLIER.
P980003|S017|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2006|06/13/2006|||OK30|ADDITION OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) SUPPLIER.
P990054|S008|Boston Scientific Corp.|2710 ORCHARD PKWY.||SAN JOSE|CA|95113||Cardiac ablation percutaneous catheter|CHILLI COOLED RPM CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2006|06/13/2006|||OK30|ADDITION OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) SUPPLIER.
P000032|S020|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2006|08/15/2006|||APPR|APPROVAL FOR A CHANGE IN ADHESIVE FORMULATION USED TO BOND THE THERMOCOUPLE AND HEATER WIRES FOR THE DEVICE.
P030026|S010|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2006|06/05/2006|||OK30|ADDITION OF A SPECIFICATION FOR A RAW MATERIAL.
P860004|S087|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2006|11/22/2006|||APPR|APPROVAL FOR CHANGES TO THE ELECTRICAL TEST SPECIFICATIONS OF THE MODEL 8637 PUMP.
P030004|S001|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM|MFE|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2006|06/22/2006|||OK30|CHANGE IN THE MANUFACTURING INSTRUCTIONS TO EMPHASIZE A CONTINUOUS MIXING PROCESS.
P990055|S009|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA)|NAF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2006|11/06/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE LOCATED AT FISHER DIAGNOSTICS, MIDDLETOWN, VIRGINIA.
P950021|S008|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSAY (CPSA)|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2006|11/06/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE LOCATED AT FISHER DIAGNOSTICS, MIDDLETOWN, VIRGINIA.
P880003|S088|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2006|06/16/2006|||OK30|CHANGE IN A "JOINING" PROCESS WHERE A DIFFERENT SOLVENT OR ENERGY SOURCE IS USED TO JOIN THE CATHETER INNER AND OUTER BODIES TO THE HUBS.
P040043|S010|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2006|06/16/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE PROCEDURES EMPLOYED IN THE LABELING OF THE GORE TAG THORACIC ENDOPROSTHESIS.  THESE MODIFICATIONS ARE INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE BY MINIMIZING THE POTENTIAL FOR MISLABELING OF DEVICES.
P840064|S031|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2006|06/16/2006|||OK30|CHANGE IN STERILIZATION PROCESS PARAMETERS.
P890047|S018|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2006|06/16/2006|||OK30|CHANGE IN STERILIZATION PROCESS PARAMETERS.
P020003|S004|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Prosthesis, testicular|COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS|FAF|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2006|08/23/2006|||APPR|APPROVAL TO ADD BLACK INK TO IMPROVE THE VISIBILITY OF THE SERIAL NUMBERS.
P030004|S002|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM|MFE|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2006|11/29/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
P050009|S002|Biomet, Inc.|P.O. Box 587||Warsaw|IN|46581|0587|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|C2A-TAPER ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2006|06/16/2006|||OK30|REPLACEMENT OF THE PREVIOUS SOFTWARE SYSTEM WITH AN IMAGE ANALYZER SOFTWARE AND THE REVISION OF THE POROUS COATING TEST PROCEDURES.
P990033|S007|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT|NPZ|DE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/22/2006|06/06/2006|||APPR|APPROVAL FOR THE CHANGE IN INDICATION FOR USE - THE DEVICE IS NO LONGER INTENDED FOR REUSE AFTER RESTERILIZATION AND WILL BE LABELED AS A SINGLE USE ONLY DEVICE.
P010012|S132|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTRAK RENEWAL 3|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/2006|06/22/2006|||APPR|APPROVAL TO ADD WARNING REGARDING CORRECT DEVICE IMPLANT ORIENTATION.
P960040|S128|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/2006|06/22/2006|||APPR|APPROVAL TO ADD WARNING REGARDING CORRECT DEVICE IMPLANT ORIENTATION.
P030025|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2006|06/08/2006|||OK30|CHANGE THE INSPECTION CRITERIA FOR THE CREASES LOCATED IN THE PROXIMAL BALLOON BOND.
P990080|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON AND TECNIS POSTERIOR CHAMBER INTRAOCULAR LENS (IOLS)|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2006|05/01/2007|||APPR|APPROVAL FOR A CHANGE IN TEST METHOD FOR THE IOL POUCH.
P020009|S027|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2006|06/08/2006|||OK30|CHANGE THE INSPECTION CRITERIA FOR THE CREASES LOCATED IN THE PROXIMAL BALLOON BOND.
P040016|S011|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2006|06/08/2006|||OK30|CHANGE THE INSPECTION CRITERIA FOR THE CREASES LOCATED IN THE PROXIMAL BALLOON BOND.
P860019|S210|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM MAVERICK|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2006|06/08/2006|||OK30|CHANGE THE INSPECTION CRITERIA FOR THE CREASES LOCATED IN THE PROXIMAL BALLOON BOND.
P040034|S003|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2006|11/17/2006|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE AT MILLSTONE MEDICAL OUTSOURCING, LLC, FALL RIVER, MASSACHUSETTS AND AN ADDITIONAL STERILIZATION SITE AT BEAMONE, LLC, LIMA, OHIO.
P910077|S062|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6482|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/2006|06/23/2006|||APPR|APPROVAL TO MODIFY THE INSTRUCTIONS FOR THE LATITUDE CLINICIAN MANUAL.
P020030|S003|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|STELIX II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/25/2006|07/12/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE HELIX MECHANISM, ADDITION OF RADIOPAQUE MARKERS, AND MODIFICATIONS TO THE DEVICE INSPECTION PROCEDURES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASY TURN MODELS BRF24D, BRF25D, AND BRF26D AND ARE DESIGNED TO BE USED WITH AN IMPLANTABLE PACEMAKER FOR PACING AND SENSING OF THE HEART.
P000044|S013|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/2006|07/14/2006|||APPR|APPROVAL FOR REMOVAL OF A WARNING REGARDING ASSAY PERFORMANCE CHARACTERISTICS WITH NEONATES.
P980025|S001|CARESTREAM DENTAL LLC|1765 THE EXCHANGE||ATLANTA|GA|30339||Analyzer,medical image|LOGICON CARIES DETECTOR|MYN|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2006|01/12/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GA INDUSTRIES, RANCHO PALOS VERDES, CALIFORNIA.
P970003|S067|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY PERENNIA MODEL 303 LEAD|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2006|06/22/2006|||OK30|CHANGE TO THE JOINING PROCESS FOR THE LEAD MODEL 303.
P860019|S211|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK FAMILY PTCA BALLOON CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2006|06/23/2006|||OK30|REMOVAL OF A REDUNDANT IN-PROCESS INSPECTION FOR BALLOON BUNCHING FOR SELECT SIZES OF MAVERICK OTW AND MAVERICK2 MR PTCA CATHETERS.
P020026|S021|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS ELUTING CORONARY STENT|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2006|09/07/2006|||APPR|APPROVAL TO INCLUDE A SECOND IDENTITY ANALYTICAL TEST AT THE SITE IN SAN GERMAN, PUERTO RICO.
P020026|S022|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS ELUTING CORONARY STENT|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2006|09/28/2006|||APPR|APPROVAL FOR CHANGING A MEASUREMENT SYSTEM AND PROCESS CONTROL METHODOLOGY.
P010012|S133|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL AND CONTAK RENEWAL 3|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/2006|07/17/2006|||APPR|APPROVAL FOR LABELING CHANGES TO THE CONTAK RENEWAL AND CONTAK RENEWAL 3 TO ENSURE CONSISTENCY WITH THE APPROVED LABELING FOR THE CONTAK RENEWAL 3RF.
P910023|S110|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2006|06/28/2006|||OK30|ADD A VENDOR FOR WELDED HALF-CAN COMPONENTS.
P960013|S020|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL MODEL 1488T/TC & 1688T/TC LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2006|06/26/2006|||OK30|CHANGES TO THE INSPECTION PROCESS FOR MEDICAL ADHESIVE ON THE ELECTRODE RING DURING PRODUCTION OF THE LEADS.
P010033|S011|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON TB GOLD IN TUBE|NCD|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2006|10/10/2007|||APPR|APPROVAL FOR A MODIFICATION OF THE QUANTIFERON - TB GOLD TO AN IN-TUBE COLLECTION SYSTEM THAT CONSISTS OF THREE BLOOD COLLECTION TUBES, NIL, TB ANTIGEN, AND MITOGEN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD IN-TUBE AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING A PEPTIDE COCKTAIL SIMULATING ESAT-6, CFP-10 AND TB 7.7(P4) PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD DRAWN DIRECTLY INTO SPECIALIZED BLOOD COLLECTION TUBES.  DETECTION OF INTERFERON-Y BY ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) IS USED TO IDENTIFY IN VITRO RESPONSES TO THESE PEPTIDE ANTIGENS THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION.
P020026|S023|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2006|11/09/2006|||APPR|APPROVAL FOR A CHANGE INVOLVING USE OF A NEW CONTRACTOR FOR QUALITY CONTROL TESTING.
P980023|S023|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2006|07/11/2006|||APPR|APPROVAL FOR A LEAD BASED ON THE KENTROX SL AND LINOX SD ICD LEADS WITH 0.11 MM FILAMENTS IN THE LEAD TIP CONDUCTOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD.  CURRENTLY, DATA IS NOT AVAILABLE REGARDING THE USE OF THESE LEAD SYSTEMS WITH ICDS OF OTHER MANUFACTURERS.  USE OF OTHER ICDS MAY ADVERSELY AFFECT SENSING AND/OR THERAPY DELIVERY.
P040042|S003|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2006|07/20/2006|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE WHICH ADDED A VOLUME CONTROL TO THE AUDIBLE OUTPUT DEVICE TO PERMIT THE USER TO VARY THE VOLUME OF THE CONTINUOUS BEEPING SOUND MADE DURING RADIOFREQUENCY DELIVERY OF POWER.
P980016|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR/VR MODELS 7274, 7230B, 7230CX, 7230E|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2006|07/26/2006|||APPR|APPROVAL FOR A MODIFICATION TO THE HIGH VOLTAGE CAPACITOR LINER USER IN THE REFERENCED DEFIBRILLATORS.
P950020|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME & CUTTING BALLOON ULTRA|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/2006|06/30/2006|||APPR|APPROVAL FOR CHANGES TO THE DIRECTIONS OF USE (DFU) MANUAL.
P930038|S047|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2006|06/26/2006|||OK30|ALTERNATIVE MOLD-GATE PROCESS.
P010031|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS MODEL 7277, INSYNC II, MARQUIS MODEL 7289, INSYNC III MARQUIS MODEL 7279, INSYNC II PROTECT MODEL 7295|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2006|07/26/2006|||APPR|APPROVAL FOR A MODIFICATION TO THE HIGH VOLTAGE CAPACITOR LINER USER IN THE REFERENCED DEFIBRILLATORS.
P020018|S010|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/2006|09/07/2006|||APPR|APPROVAL FOR THE 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT.
P950022|S030|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST OPTIM LEADS MODELS 7020, 7021,7022,7030,7031,7070 AND 7071|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/05/2006|07/07/2006|||APPR|APPROVAL TO PLACE AN OVERLAY OVER THE SILICONE LEAD BODY OF THE RIATA ST LEADS TO CREATE THE NEW RIATA ST OPTIM LEAD MODELS 7020, 7021, 7022, 7030, 7031, 7070 AND 7071 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.
P010031|S043|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC INSYNC MAXIMO AND INSYNC SENTRY DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/05/2006|06/30/2006|||APPR|APPROVAL FOR THE MODEL 9998 V2.2 SOFTWARE FOR USE ON THE MODEL 2090 PROGRAMMERS.
P020047|S005|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK RX AND OTW VISION AND MINI VISION CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2006|11/21/2006|||APPR|APPROVAL FOR A CHANGE TO THE TYPE OF LASER USED TO CUT THE STENTS.
P960009|S040|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA THERAPY SYSTEM|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/05/2006|10/05/2006|||APPR|APPROVAL FOR REPLACING THE EXISTING TUNNELING TOOLS WITH A NEW MODIFIED VERSION.
P880081|S032|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2006|07/20/2006|||APPR|APPROVAL FOR A CHANGE IN HAPTIC MATERIAL, ADDITION OF THE OPTIEDGE AND OF A MODIFIED PROLATE ANTERIOR OPTIC SURFACE TO THE SI20NB LENS AND LABELING CLAIMS FOR REDUCED POSTOPERATIVE SPHERICAL ABERRATIONS AND IMPROVED NIGHT-DRIVING SIMULATOR PERFORMANCE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002) AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION OR PHACOELMULSIFICA-TION.  THESE DEVICES ARE INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P040034|S004|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/2006|08/02/2006|||APPR|APPROVAL FOR: 1) USE OF NOF CORPORATION AS AN ALTERNATE VENDOR FOR FUNCTIONALIZING RAW PEG-POLYOL MATERIAL TO PEG-SG FOR USE IN THE DURASEAL DURAL SEALANT PRODUCT, AND 2) IMPLEMENTATION OF AN IN-PROCESS PARTICLE SIZE INSPECTION STEP PRIOR TO THE MILLING STEP.
P030054|S030|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC/EPIC II HF & ATLAS + HF CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P040052|S001|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|MONOPREP PAP TEST|MKQ|PA|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|05/03/2006|12/14/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P050042|S001|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2006|08/14/2006|||APPR|APPROVAL FOR THE ADDITION OF A TEST METHOD TO DETECT CHANGES BETWEEN THE BULK AND THE MASTER LOT (CUSTOMER RELEASE) TESTING STAGES.
P050012|S001|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|SEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Panel Track|Change Design/Components/Specifications/Material|N|06/19/2006|05/31/2007|07M-0255|06/28/2007|APPR|APPROVAL FOR THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM (STS-7 SYSTEM).  THE DEVICE IS INDICATED FOR THE FOLLOWING:  THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM (STS-7 SYSTEM) IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES.  THE STS-7 SYSTEM IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES.  THE DEVICE IS FOR PRESCRIPTION USE ONLY.  THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.  THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS.  INTERPRETATION OF THE STS-7 SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P040014|S003|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETER AND IBI 1500T CARDIAC ABLATION GENERATOR|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/2006|11/13/2006|||APPR|APPROVAL FOR BI-DIRECTIONAL FUNCTIONALITY DESIGN MODIFICATIONS TO THE THERAPY ABLATION CATHETER.
P040028|S002|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD|SUITE 11|SAN DIEGO|CA|92121||Sensor,electro-optical(for cervical cancer)|LUMA CERVICAL IMAGING SYSTEM|MWM|OB|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2006|06/26/2006|||APPR|APPROVAL FOR TWO ADDITIONAL INTEGRITY VERIFICATION TESTS.
P980050|S024|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE  MODEL9974|LWS|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/12/2006|09/13/2006|||APPR|APPROVAL FOR MODIFICATIONS  TO THE POST APPROVAL STUDY TO UPDATE THE RESPECT STUDY PROTOCOL AND RELATED DOCUMENTATION TO INCORPORATE THE ENRHYTHM DEVICE (MODEL P15001DR), THE ENRHYTHM SOFTWARE (MODEL 9987), AND THE INCHECK PATIENT ASSISTANT (MODEL 2696).
P020047|S006|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION CORONARY STENT SYSTEMS|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/2006|07/13/2006|||APPR|APPROVAL FOR MODIFICATIONS FOR THE IFUS TO INCLUDE ADDITIONAL INFORMATION REGARDING THE MATERIAL COMPONENTS OF THE STENTS.
P970020|S047|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK CORONARY STENT SYSTEMS|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/2006|07/13/2006|||APPR|APPROVAL FOR MODIFICATIONS FOR THE IFUS TO INCLUDE ADDITIONAL INFORMATION REGARDING THE MATERIAL COMPONENTS OF THE STENTS.
P830045|S100|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON & PHOENIX PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P880006|S043|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|REGENCY PACEMAKER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P880086|S122|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VARIOUS MODELS OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P970013|S010|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKER|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P030035|S016|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P910023|S111|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|VARIOUS MODELS OF ICD'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P010054|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS AND HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS|LOM|MI|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2006|06/30/2006|||APPR|APPROVAL FOR A MODIFICATION TO THE STANDARDIZATION PROCESS FOR THE ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS ASSAY FOR USE ON THE ELECSYS 2010 ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS AND IS INDICATED FOR THE QUALITATIVE DETECTION IN HUMAN SERUM AND PLASMA.
P040034|S005|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2006|09/15/2006|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT BEAMONE LLC, LIMA, OHIO.
P860003|S044|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/14/2006|07/14/2006|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON EXTRACORPOREAL BLOOD VOLUME MANAGEMENT AND THE IMPORTANCE OF TESTING PATIENTS' HEMATOCRIT VALUES.
P900070|S034|ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI|15900 Valley View Ct.||Sylmar|CA|91342||Pulse generator, permanent, implantable|META & TEMPO PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P880038|S037|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|META PACEMAKER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P820018|S077|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS MODELS OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2006|07/11/2006|||APPR|APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.
P050051|S001|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB REAGENT KIT, ARCHITECT AUSAB CALIBRATORS, ARCHITECT AUSAB CONTROLS|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2006|08/07/2006|||APPR|APPROVAL FOR THE ADDITION OF A TEST METHOD TO DETECT CHANGES BETWEEN THE BULK AND THE MASTER LOT (CUSTOMER RELEASE) TESTING STAGES.
P970003|S068|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2006|02/08/2007|||APPR|APPROVAL FOR USE OF AN ADDITIONAL STERILIZATION METHOD.
P890003|S105|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENTRUST ICD AND THE CARDIOSIGHT READER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2006|07/12/2006|||APPR|APPROVAL FOR ADDING SUPPORT FOR THE CONCERTO MODEL C154DWK AND VIRTUOSO MODELS D154AWG/D154VWC TO THE MODEL 2020A CARDIOSIGHT READERS AND THE CORRECTION OF AN ANOMALY IN THE MODEL 2491 DDMA AFFECTING THE ENTRUST FAMILY OF ICDS.
P020036|S003|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2006|07/19/2006|||OK30|CHANGE TO THE BIO-INERT FILLER INGREDIENT THAT IS PRIMARILY USED AS A THICKENING AGENT FOR THE UV ADHESIVE.
P020036|S004|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2006|07/19/2006|||OK30|CHANGE TO THE COINING AND RIVETING PROCESS OF THE TANTALUM MICROSMARKERS TO THE S.M.A.R.T. CONTROL STENT.
P010031|S044|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2006|07/12/2006|||APPR|APPROVAL FOR ADDING SUPPORT FOR THE CONCERTO MODEL C154DWK AND VIRTUOSO MODELS D154AWG/D154VWC TO THE MODEL 2020A CARDIOSIGHT READERS AND THE CORRECTION OF AN ANOMALY IN THE MODEL 2491 DDMA AFFECTING THE ENTRUST FAMILY OF ICDS.
P980016|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2006|07/12/2006|||APPR|APPROVAL FOR ADDING SUPPORT FOR THE CONCERTO MODEL C154DWK AND VIRTUOSO MODELS D154AWG/D154VWC TO THE MODEL 2020A CARDIOSIGHT READERS AND THE CORRECTION OF AN ANOMALY IN THE MODEL 2491 DDMA AFFECTING THE ENTRUST FAMILY OF ICDS.
P050007|S003|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2006|09/22/2006|||APPR|APPROVAL FOR: 1) INCREASING THE RADII OF THE DISTAL END OF THE SUPPORT TUBE (CLIP DELIVERY TUBE) FROM 0.002 INCHES TO 0.004 INCHES; 2) ADDING A 45 DEGREE CHAMFER TO THE PROXIMAL EDGE OF THE DISTAL RING; AND 3) REMOVING THE ?6F? NOTATION ON THE HANDLE OF THE DEVICE.
P040038|S002|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2006|07/18/2006|||OK30|CHANGES REGARDING ADHESIVE BONDING, ABRASION PROCESS CHANGE, STENT PROCESS CHANGE, AND CHANGES TO FINAL INSPECTION.
P040038|S003|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2006|05/10/2007|||APPR|APPROVAL FOR CHANGES TO THE INSPECTIONS OF THE STENTS PERFORMED AT THE FACILITY AND BY THE SUPPLIER.
P040013|S004|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENHANCED MATRIX|NPZ|DE|Normal 180 Day Track No User Fee|Other Report|N|05/31/2006|07/17/2006|||APPR|APPROVAL FOR A NEW ELISA PDGF-BB IDENTITY TEST.
P030025|S033|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2006|12/21/2006|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION CHAMBER AT A CONTRACT STERILIZATION FACILITY.
P040016|S012|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2006|12/21/2006|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION CHAMBER AT A CONTRACT STERILIZATION FACILITY.
P960040|S129|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2006|07/19/2006|||OK30|MODIFICATION TO A TOOL USED DURING THE HYBRID FOLDING PROCESS IN ELECTRONIC ASSEMBLY.
P000039|S016|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2006|07/18/2006|||OK30|CHANGE TO THE CLEANING PROCESS FOR THE DEVICE.
P020024|S011|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2006|07/18/2006|||OK30|CHANGE TO THE CLEANING PROCESS FOR THE DEVICE.
P860057|S035|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2800 & 2800TFX|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2006|07/18/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED SEWING OF THE ANCHOR SEAMLINE STITCH.
P990037|S024|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT|MGB|CV|Panel Track|Change Design/Components/Specifications/Material|N|06/22/2006|12/22/2006|07M-0188|05/11/2007|APPR|APPROVAL FOR A NEW INDICATION FOR USE FOR THE D-STAT FLOWABLE HEMOSTAT.  THE DEVICE IS INDICATED FOR USE IN HIGH-RISK ANTI-COAGULATED PATIENTS UNDERGOING IMPLANTATION OF A PULSE GENERATOR (E.G., PACEMAKER OR ICD) TO REDUCE THE FREQUENCY OF CLINICALLY RELEVANT HEMATOMA FORMATION IN THE PREPECTORAL POCKET.  D-STAT FLOWABLE IS INDICATED FOR USE IN HIGH-RISK ANTI-COAGULATED PATIENTS UNDERGOING IMPLANTATION OF A PULSE GENERATOR (E.G., PACEMAKER OR ICD TO REDUCE THE FREQUENCY OF CLINICALLY RELEVANT HEMATOMA FORMATION IN THE PREPECTORAL POCKET.  HIGH-RISK PATIENTS ARE DEFINED AS THOSE WHOSE ANTI-COAGULATION REGIMENS WILL RESUME WITHIN 24 HOURS OF IMPLANT.  CLINICALLY RELEVANT HEMATOMAS ARE DEFINED AS THOSE THAT RESULT IN AN ALTERATION IN THE STANDARD OF CARE RESULTANT OF HEMATOMA FORMATION INCLUDING ALTERATION (I.E. SUSPENSION OR DISCONTINUATION) OF THE ANTICOAGULANT THERAPY REGIMEN (HEPARIN, LMWH, WARFARIN, OR CLOPIDOGREL), APPLICATION OF A COMPRESSION BANDAGE AND EVACUATION OF THE HEMATOMA.
P040038|S004|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2006|06/30/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING AND DEVICE INSPECTION PROCESSES.
P960040|S130|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV AICD SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2006|07/26/2006|||OK30|CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.
P940031|S057|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR PACEMAKER SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2006|07/26/2006|||OK30|CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.
P910077|S063|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 3120 ZOOM LATITUDE PROGRAMMER|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2006|07/26/2006|||OK30|CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.
P910023|S112|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE, MODEL V-100|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2006|07/11/2006|||APPR|APPROVAL FOR THE ST. JUDE MEDICAL ATLAS II/II+ VR/DR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM.  THE ATLAS II/II+ DEVICES ARE SUPPORTED BY THE MODEL 3510 PROGRAMMER WITH MODEL 3307 V6.1 (OR HIGHER) PROGRAMMER SOFTWARE OR THE MERLIN PATIENT CARE SYSTEM MODEL 3650 WITH MODEL 3330 V3.0 (OR HIGHER) PROGRAMMER SOFTWARE.
P010012|S134|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK CRT-D SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2006|07/26/2006|||OK30|CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.
P030054|S031|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF V-338|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2006|07/11/2006|||APPR|APPROVAL FOR THE ST. JUDE MEDICAL ATLAS II/II+ VR/DR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM.  THE ATLAS II/II+ DEVICES ARE SUPPORTED BY THE MODEL 3510 PROGRAMMER WITH MODEL 3307 V6.1 (OR HIGHER) PROGRAMMER SOFTWARE OR THE MERLIN PATIENT CARE SYSTEM MODEL 3650 WITH MODEL 3330 V3.0 (OR HIGHER) PROGRAMMER SOFTWARE.
P030005|S037|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR CRT-P SYSTEM|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2006|07/26/2006|||OK30|CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.
P840068|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA PACEMAKER SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2006|07/26/2006|||OK30|CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES.
P030006|S011|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2006|08/10/2006|||APPR|APPROVAL FOR MANUFACTURING CHANGES TO CORRECT THE INNER MANIFOLD BOND OF THE CATHETER AND TO CONFIRM DIMENSIONS OF TUBING USED WITH THE HEAT EXCHANGER.
P880086|S123|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VICTORY AF DR PULSE GENERATOR MODEL 5382|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/2006|03/16/2007|||APPR|APPROVAL FOR THE VICTORY AF DR PULSE GENERATOR MODEL 5382.
P900061|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2006|07/12/2006|||APPR|APPROVAL FOR THE ADDITION OF THE PRESCRIPTION LABEL INADVERTENTLY OMITTED FROM THE MANUALS FOR THE MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) AND THE MODEL 5460 ACE HEADER.
P040012|S016|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2006|07/11/2006|||APPR|APPROVAL FOR CHANGES TO THE LABELING PRINTING AND INSPECTION PROCEDURES.
P950037|S045|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS MODELS OF PACEMAKERS ICS 3000/ EPR 1000 PLUS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2006|07/26/2006|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE MODIFICATIONS (601.U AND A-K00.8.U) FOR USE IN BIOTRONIK PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.  THE MODIFICATIONS INCLUDED ADDING THE 1-OPT FEATURE, EXPANDING PROGRAMMER CAPABILITIES, IMPROVING PRINTING AND DATA IMPORT/EXPORT CAPABILITIES, ENHANCING COMMUNICATION AND MEMORY, UPDATING PROGRAMMABILITY AND RAM AND CORRECTING SOFTWARE ANOMALIES.  THE SOFTWARE IS FOR USE WITH EPR 1000 PLUS PROGRAMMING SYSTEM, TMS 1000 PLUS PROGRAMMING SYSTEM AND ICS 3000 IMPLANT CONTROL SYSTEM.
P980023|S024|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|VARIOUS MODELS ICD'S TMS 1000 PLUS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2006|07/26/2006|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE MODIFICATIONS (601.U AND A-K00.8.U) FOR USE IN BIOTRONIK PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.  THE MODIFICATIONS INCLUDED ADDING THE 1-OPT FEATURE, EXPANDING PROGRAMMER CAPABILITIES, IMPROVING PRINTING AND DATA IMPORT/EXPORT CAPABILITIES, ENHANCING COMMUNICATION AND MEMORY, UPDATING PROGRAMMABILITY AND RAM AND CORRECTING SOFTWARE ANOMALIES.  THE SOFTWARE IS FOR USE WITH EPR 1000 PLUS PROGRAMMING SYSTEM, TMS 1000 PLUS PROGRAMMING SYSTEM AND ICS 3000 IMPLANT CONTROL SYSTEM.
P000009|S019|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|VARIOUS MODELS OF ICD'S|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2006|07/26/2006|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE MODIFICATIONS (601.U AND A-K00.8.U) FOR USE IN BIOTRONIK PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.  THE MODIFICATIONS INCLUDED ADDING THE 1-OPT FEATURE, EXPANDING PROGRAMMER CAPABILITIES, IMPROVING PRINTING AND DATA IMPORT/EXPORT CAPABILITIES, ENHANCING COMMUNICATION AND MEMORY, UPDATING PROGRAMMABILITY AND RAM AND CORRECTING SOFTWARE ANOMALIES.  THE SOFTWARE IS FOR USE WITH EPR 1000 PLUS PROGRAMMING SYSTEM, TMS 1000 PLUS PROGRAMMING SYSTEM AND ICS 3000 IMPLANT CONTROL SYSTEM.
P010020|S002|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICON NEOSPHINCTER|MIP|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/2006|12/21/2006|||APPR|APPROVAL FOR LABELING CHANGES.
P040012|S017|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2006|07/14/2006|||APPR|APPROVAL FOR A TIGHTENING OF THE SAMPLING LEVEL FOR PARTIAL STENT DEPLOYMENT.
P910023|S113|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE,PHOTON, EPIC, ATLAS,EPIC II AND ATLAS II AND ICD FAMILIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2006|07/31/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED MASKING PROCESS.
P030054|S032|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF, ATLAS + HF. EPIC II HF CRT- FAMILIES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2006|07/31/2006|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED MASKING PROCESS.
P960013|S021|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL FAMILY OF LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2006|07/19/2006|||OK30|ALTERNATE AUTOMATED TEST PROCESS DURING THE INSPECTION OF TENDRIL FAMILY OF LEADS.
P010014|S009|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE|NRA|OR|Special (Immediate Track)||N|07/03/2006|07/18/2006|||APPR|APPROVAL FOR CHANGES TO THE PROCESS SPECIFICATIONS FOR THE 9-STAGE KERRY CLEANING PLANT USED IN THE ULTRASONIC CLEANING OF THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM METALLIC COMPONENTS (FEMORAL AND TIBIAL).  THE CHANGES REQUIRE DETAILED MONITORING OF THE ULTRASONIC EQUIPMENT TO ENSURE THE ADEQUACY OF ITS OUTPUT.
P000029|S018|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/03/2006|07/27/2006|||APPR|APPROVAL FOR LABELING CHANGES IN THE DEFLUX PACKAGE INSERT.
P960043|S059|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE A-T SUTURE MEDIATED CLOSURE(SMC) SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/2006|08/08/2006|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) FOR THE PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM.
P000041|S005|RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|RAPIDSCREEN RS-2000D|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2006|11/01/2006|||APPR|APPROVAL FOR DESIGN CHANGES TO THE RAPIDSCREEN RS-2000D TO PROVIDE REDUCED NUMBER OF FALSE POSITIVES PER IMAGE WITH A STATISTICALLY INSIGNIFICANT IMPACT ON THE DETECTION SENSITIVITY.
P040038|S006|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice||N|07/10/2006|11/21/2006|||APPR|APPROVAL TO 1) TIGHTEN THE CONNECTOR INNER DIAMETER SPECIFICATION TOLERANCE; AND 2) MODIFY THE STENT HEAT TREATMENT PROCESS.
P040012|S018|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|135 Review Track For 30-Day Notice||N|07/10/2006|10/02/2006|||APPR|APPROVAL FOR A CHANGE IN THE METHOD OF INSPECTING THE ACCULINK STENT OUTER DIAMETER.
P030019|S010|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2006|08/09/2006|||OK30|CHANGE IN VENT FILTER TYPE USE IN THE MANUFACTURE OF THE DEVICE.
P010054|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY TEST SYSTEM|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2006|07/28/2006|||APPR|APPROVAL FOR CHANGES IN THE QUALITY CONTROL (QC) TESTING PROCEDURE OF RAW MATERIALS FOR CALIBRATORS AND CONTROLS.
P980049|S023|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE FOR CHORUS MODELS 6001, 6003, 6004, 6033, AND 6034|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2006|07/26/2006|||APPR|APPROVAL FOR THE ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE.
P950029|S026|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|RATE RESPONSIVE PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2006|07/26/2006|||APPR|APPROVAL FOR THE ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE.
P900022|S007|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|NON-RATE RESPONSIVE PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2006|07/26/2006|||APPR|APPROVAL FOR THE ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE.
P010038|S012|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/2006|04/04/2008|||APPR|APPROVAL FOR THE USE OF THE SECONDLOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY WITH FUJI MEDICAL SYSTEMS COMPUTED RADIOGRAPHY MAMMOGRAMS (CRM).  THE DEVICE IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM FUJIFILM MEDICAL SYSTEMS COMPUTED RADIOGRAPHY SYSTEM (FUJI CRM) TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER AN INITIAL READING HAS BEEN COMPLETED.
P870072|S034|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Real-Time Process||N|07/12/2006|06/28/2007|||APPR|APPROVAL FOR A MATERIAL CHANGE IN THE TUBING THAT CONNECTS THE BODY OF THE PARACORPOREAL THORATEC VENTRICULAR ASSIST DEVICE WITH THE METAL Y-CONNECTOR THAT SPLITS THE LINE INTO SEPARATE ELECTRICAL AND PNEUMATIC CONNECTIONS.
P990052|S013|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE|MPV|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2006|11/02/2006|||APPR|APPROVAL TO ESTABLISH A SECOND SOURCE SUPPLIER, MORGAN ADVANCED CERAMICS, FOR THE DEMODULATOR HOUSING (IMPLANT ELECTRONICS CASE).
P890003|S106|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR MODEL 2490H VERSION A07801 REVISION C|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2006|08/24/2006|||APPR|APPROVAL FOR THE MEDTRONIC CARELINK MONITOR MODEL 2490H VERSION A07801 REVISION C.
P980035|S058|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR MODEL 2490H VERSION A07801 REVISION C|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2006|08/24/2006|||APPR|APPROVAL FOR THE MEDTRONIC CARELINK MONITOR MODEL 2490H VERSION A07801 REVISION C.
P970003|S069|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|07/12/2006|08/09/2006|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL REVISION FOR THE DEVICE.
P030054|S033|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF SYSTEM|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2006|08/09/2006|||OK30|CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
P030035|S017|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2006|08/09/2006|||OK30|CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
P830045|S101|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON, PHOENIX, MULTILOG & SENSORITHM PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2006|08/09/2006|||OK30|CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
P880006|S044|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2006|08/09/2006|||OK30|CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
P880086|S124|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SYNCHRONY MODEL 2020T PULSE GENERATOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2006|08/09/2006|||OK30|CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
P910023|S114|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED THERAPY DEFIBRILLATION SYSTEM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2006|08/09/2006|||OK30|CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
P970013|S011|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY SR + MODEL 2425T PULSE GENERATOR|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2006|08/09/2006|||OK30|CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
P040012|S019|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2006|09/20/2006|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCESS FOR BONDING THE TIP BUMP TO THE GUIDEWIRE LUMEN IN RX ACCULINK AND ACCULINK CAROTID STENTS.
P040012|S020|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2006|01/05/2007|||APPR|APPROVAL FOR A CHANGE IN THE CLEANING METHODS TO REMOVE MANUFACTURING MATERIALS IN RX ACCULINK AND ACCULINK CAROTID STENTS.
P040022|S002|Medtronic Vascular|37A Cherry Hill Drive||Danvers|MA|01923||Device, hemostasis, vascular|ANGIOLINK VASCULAR CLOSURE SYSTEM|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2006|11/01/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STD MED, INC., STOUGHTON, MASSACHUSETTS.
P980016|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST AND VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2006|08/15/2006|||OK30|CHANGES IN METHOD OF MANUFACTURE FOR CONTACTS ON SEVERAL COMPONENTS AND CHANGES TO THE WELD STRENGTH TEST METHOD.
P040003|S002|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000|NRZ|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/2006|02/27/2007|||APPR|APPROVAL TO IMPLEMENT THE VERSION 4.2 SOFTWARE AND A NEW PATIENT TABLE (WITH OTHER RELATED HARDWARE) THAT ALLOW FOR OPERATION OF THE EXABLATE 2000 SYSTEM WITH THE GENERAL ELECTRIC 3T MAGNETIC RESONANCE IMAGING (MRI) SYSTEM.  VERSION 4.2 SOFTWARE PROVIDES FOR AN INTERLEAVED MODE OF OPERATION, ELONGATED FOCAL SPOTS, AND A SCALE-ABLE COOLING DURING.
P960058|S054|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/17/2006|07/28/2006|||APPR|APPROVAL FOR A COCHLEAR IMPLANT SYSTEM NAME CHANGE FROM "HIRESOLUTION BIONIC EAR SYSTEM" TO "HARMONY HIRESOLUTION BIONIC EAR SYSTEM".  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS AND THE PEDIATRIC POPULATION AGED 12 MONTHS THROUGH 17 YEARS, 11 MONTHS OF AGE.
P010031|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2006|08/16/2006|||OK30|CHANGES IN METHOD OF MANUFACTURE FOR CONTACTS ON SEVERAL COMPONENTS AND CHANGES TO THE WELD STRENGTH TEST METHOD.
P970003|S070|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/17/2006|09/05/2006|||APPR|APPROVAL FOR A CHANGE FROM ADDING A STRAIN RELIEF GROMMET TO THE SERIAL DATA CABLE OF THE MODEL 201 PROGRAMMING WAND DURING FINAL ASSEMBLY TO MOLDING AN IMPROVED STRAIN RELIEF ONTO THE SERIAL DATA CABLE DURING ITS MANUFACTURE AND CHANGES TO THE TIE-DOWN USED IN THE MODEL 302 LEAD, THE MODEL 303 LEAD, AND THE MODEL 502 ACCESSORY PACK.
P020014|S013|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE PERMANENT BIRTH CONTROL SYSTEM|HHS|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/17/2006|09/19/2006|||APPR|APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BOOKLET.
P030019|S012|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/2006|11/08/2006|||APPR|APPROVAL FOR ELIMINATION OF THE SECOND STERILIZATION STEP FROM THE FINAL PACKAGING PROCESS, AND AN UPDATE TO THE PACKAGE LABELING TO REFLECT THIS CHANGE.
P880086|S125|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY, INTEGRITY, AND IDENTITY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2006|08/16/2006|||OK30|SOFTWARE CHANGES TO THE DOWNLOADER AND TEST SYSTEM SOFTWARE FOR THE ABOVE LISTED DEVICES.
P030035|S018|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER II BIVENTRICULAR PACING SYSTEMS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2006|08/16/2006|||OK30|SOFTWARE CHANGES TO THE DOWNLOADER AND TEST SYSTEM SOFTWARE FOR THE ABOVE LISTED DEVICES.
P030009|S005|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MIRCO-DRIVER OVER-THE -WIRE(OTW) CORONARY STENT SYSTEM & MX2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2006|08/17/2006|||OK30|QUALIFICATION AND TRANSFER OF RING TUMBLE AND ANNEALING PROCESSES TO BRUNK INDUSTRIES.
P030054|S034|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC + HF, ATLAS + HF, EPIC II + HF, ATLAS II + HF CARDIAC RESYNCHRONIZATION DEFIBRILLATORS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/2006|02/02/2007|||APPR|APPROVAL FOR THE ADDITION OF THE AF SUPPRESSION PACING FEATURE. THE SYSTEMS LISTED ABOVE ARE INDICATED AS FOLLOWS:THE SYSTEM IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. AF SUPPRESSION PACING IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH THE ABOVE ICD INDICATION AND SINUS NODE DYSFUNCTION.  IN PATIENTS INDICATED FOR AN ICD, THE SYSTEM IS ALSO INTENDED: 1) TO PROVIDE A REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION) AND HAVE A LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% AND A PROLONGED QRS DURATION; 2) TO MAINTAIN SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC (PERMANENT) ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
P860057|S036|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PERIMOUNT, PERIMOUNT MAGNA AND PERIMOUNT PLUS PERCARDIAL BIOPROSTHESES|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/2006|01/08/2007|||APPR|APPROVAL TO DECREASE THE MINIMUM LEAFLET TISSUE THICKNESS SPECIFICATION FOR THE 25MM AND 27MM VALVES.
P010003|S008|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|30-Day Notice||N|06/26/2006|07/26/2006|||OK30|CHANGE OF BSA SUPPLIERS.
P010031|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2006|08/17/2006|||OK30|CHANGES TO THE BATTERY FILL PORT TO CASE LASER SUB-ASSEMBLY WELD PROCESS.
P980016|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST AND VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2006|08/17/2006|||OK30|CHANGES TO THE BATTERY FILL PORT TO CASE LASER SUB-ASSEMBLY WELD PROCESS.
P000043|S015|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/2006|12/15/2006|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO INCORPORATE THE RESULTS OF THE 5-YEAR POSTAPPROVAL STUDY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH OF 25 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC.
P020026|S025|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|07/17/2006|08/25/2006|||APPR|APPROVAL TO ELIMINATE THE COMMITMENT TO IMPLEMENT/CONDUCT ELUTION METHODOLOGY (CURRENT METHOD 10116481) AND SPECIFICATIONS.
P010031|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2006|08/17/2006|||OK30|CHANGES TO THE LASER SEAM WELD PROCESS.
P980016|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST AND VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2006|08/17/2006|||OK30|CHANGES TO THE LASER SEAM WELD PROCESS.
P890003|S107|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|THERA/THERA-I PRODIGY SERIES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2006|08/31/2006|||APPR|APPROVAL FOR THE LONGEVITY PROJECTION UPDATE SW V1.1.
P010015|S024|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC 8040 DEVICE, INSYNC III 8042.8044 DEVICES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2006|08/31/2006|||APPR|APPROVAL FOR THE LONGEVITY PROJECTION UPDATE SW V1.1.
P040012|S022|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK & RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2006|08/17/2006|N||OK30|ADDITION OF A SEMI-AUTOMATED PROCESS TO THE AVAILABLE TECHNIQUES FOR NON-TAPERED STENT EXPANSION.
P970012|S024|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 SERIES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2006|08/31/2006|||APPR|APPROVAL FOR THE LONGEVITY PROJECTION UPDATE SW V1.1.
P980035|S059|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/650/700 , KAPPA 800/900 MODELS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2006|08/31/2006|||APPR|APPROVAL FOR THE LONGEVITY PROJECTION UPDATE SW V1.1.
P950020|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON MONORAIL DEVICE|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2006|08/22/2006|||OK30|CHANGE TO MAKE THE MID-SHAFT OF THE CATHETER MORE ROBUST TO TENSILE FAILURE.
P930014|S018|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2006|08/24/2006|||OK30|NEW STERILIZER FOR PRODUCTION USE.
P040020|S002|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2006|08/24/2006|||OK30|NEW STERILIZER FOR PRODUCTION USE.
P880087|S012|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA ANTERIOR CHAMBER IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2006|08/24/2006|||OK30|NEW STERILIZER FOR PRODUCTION USE.
P030019|S013|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|135 Review Track For 30-Day Notice||N|07/24/2006|03/15/2007|||APPR|APPROVAL FOR A CHANGE IN THE FILTER USED IN THE STERILE FILTRATION OF SODIUM HYALURONATE SOLUTION.
P000046|S014|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II AND SHELLGEL SODIUM HYALURONATE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2006|08/24/2006|||OK30|A STERILIZATION FILTER CHANGE.
P810032|S052|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA MULTI-PIECE POSTERIOR CHAMBER VS100 IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2006|08/24/2006|||OK30|NEW STERILIZER FOR PRODUCTION USE.
P840060|S030|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE POSTERIOR CHAMBER IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2006|08/24/2006|||OK30|NEW STERILIZER FOR PRODUCTION USE.
P030002|S008|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)|NAA|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2006|05/24/2007|||APPR|PERFORM MOIST HEAT STERILIZATION IN HOUSE AT EYEONICS? RANCHO CUCAMONGA FACILITY.
P020026|S026|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM)|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/2006|02/22/2011|||APPR|APPROVAL FOR THE 4.0MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTORRAIL (RX) DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME 4.00MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS OF LENGTH <=  30 MM IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER OF  >= 2.25 TO <= 4.0 MM.
P900052|S013|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM|LNY|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2006|04/05/2007|||APPR|APPROVAL FOR A SECOND OPERATOR INSPECTION FOR OUTLET TUBE AND INSERT HOLE ALIGNMENT TO CONFIRM PROPER ALIGNMENT OF THE OUTLET TUBE.
P980044|S004|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2006|08/25/2006|||OK30|INCREASE IN THE SAMPLING VOLUME FOR THE MEASUREMENT OF AIRBORNE BACTERIA AND AN INCREASE IN THE SAMPLING VOLUME FOR THE MEASUREMENT OF PRODUCT OSMOTIC PRESSURE.
P940034|S017|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)|MWA|MI|135 Review Track For 30-Day Notice||N|07/27/2006|07/18/2007|||APPR|APPROVAL FOR A CHANGE TO A QUALITY CONTROL RELEASE SPECIFICATION FOR THE ENZYME REAGENT, A COMPONENT OF THE MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST.
P810025|S026|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC & AMVISC PLUS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2006|08/24/2006|||OK30|CHANGE OF THE STERILIZATION FILTER.
P040034|S006|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2006|12/04/2006|||APPR|APPROVAL FOR THE REMOVAL OF THE FOLLOWING SENTENCE IN THE INDICATION STATEMENT: ?DURASEAL SHOULD ONLY BE USED WITH AUTOLOGOUS DURAPLASTY MATERIAL.?
P010031|S048|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VIRTUOSO MODELS D154AWG/ D154VWC IMPLANTABLE DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/2006|08/31/2006|||APPR|APPROVAL FOR UPDATES TO THE D273 AND L356 ICS.
P870038|S008|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|STARR EDWARDS SILASTIC BALL PROSTHESIS MODELS 1260 & 6120|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2006|09/29/2006|||APPR|APPROVAL FOR A CHANGE IN SUPPLIERS FOR A POLYTETRAFLUOURETHYLENE (PTFE) ROD USED IN THE MANUFACTURE OF THE DEVICE.
P980016|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO MODEL C154DWK IMPLANTABLE DEVICES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/2006|08/31/2006|||APPR|APPROVAL FOR UPDATES TO THE D273 AND L356 ICS.
P050012|S002|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM STS SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/2006|08/21/2006|||APPR|APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO ENABLE IT TO BE USED FOR CONSUMER USE.  THE SOFTWARE PROGRAM, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DM-CONSUMER AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS SYSTEM INTO A PERSONAL COMPUTER.
P030050|S002|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AESTHETIC|LMH|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2006|07/28/2009|09M-0370|08/04/2009|APPR|APPROVAL FOR SCULPTRA AESTHETIC.  THE DEVICE IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLEREGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIALWRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE.
P040013|S005|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENHANCED MATRIX|NPZ|DE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/2006|08/21/2006|||APPR|APPROVAL FOR THE BMPI STERILITY TEST METHOD TO EXTEND THE EXPIRY DATE TO 36 MONTHS AND IS INDICATED TO TREAT THE FOLLOWING PERIODONTALLY RELATED DEFECTS: 1) INTRABONY PERIODONTAL DEFECTS; 2) FURCATION PERIODONTAL DEFECTS; AND 3) GINGIVAL RECESSION ASSOCIATED WITH PERIODONTAL DEFECTS.
P960004|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FINELINE II & THINLINE II|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2006|02/28/2007|||APPR|PROCESS CHANGE TO THE FINELINE II AND THINLINE II J-FORMING MANUFACTURING METHOD TO IMPROVE RETENTION CHARACTERISTICS OF THE ATRIAL J-SHAPE.
P040042|S004|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/01/2006|09/20/2006|||APPR|APPROVAL FOR THE ADDITION OF AN EXTENDER MODULE TO THE ACCESSORY LIST FOR THE GENERATOR.  THE EXTENDER MODULE WILL ALLOW THE USER TO PLACE THE GENERATOR UP TO AN ADDITIONAL TWENTY FEET FROM THE PATIENTS.
P980044|S005|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2006|02/13/2007|||APPR|APPROVAL FOR THE ELIMINATION OF A STEP IN THE ACTIVE INGREDIENT SODIUM HYALURONATE MANUFACTURING PROCESS AND MOVING THAT MANUFACTURING PROCESS FROM THE CURRENT TWO BUILDINGS TO A NEW WING IN AN EXISTING BUILDING.
P990066|S024|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE ESSENTIAL SYSTEM|MUE|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/02/2006|09/01/2006|||APPR|APPROVAL TO ADD STATEMENTS TO THE USER AND INSTALLATION INSTRUCTIONS TO CAUTION ABOUT THE EQUIPMENT THAT MAY NOT PROPERLY DISPLAY OR PRINT THE LARGER IMAGES PRODUCED BY THE SENOGRAPHE ESSENTIAL.
P040012|S023|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice||N|08/02/2006|09/01/2006|||OK30|CHANGE TO THE PRODUCT ACCEPTANCE AUDIT PROCEDURE FOR THE RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS.
P010013|S017|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2006|10/05/2006|||APPR|APPROVAL FOR A CHANGE IN SUPPLIER OF THE FIRST STAGE CO2 REGULATOR FOR THE NOVASURE?S CAVITY INTEGRITY ASSESSMENT SYSTEM.
P980043|S010|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2006|09/01/2006|||OK30|CHANGE TO THE SUPPLIER OF THE PLOYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.
P980016|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SELECTED FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice||N|08/03/2006|01/24/2007|||APPR|APPROVAL FOR A CHANGE IN THE ALLOWABLE EXPOSURE LIMIT FOR THE BATTERY AND CAPACITOR AT THE FINAL DEVICE MANUFACTURING SITE.
P010031|S049|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS INSYNC FAMILIES OF CRT-ICDS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2006|01/24/2007|||APPR|APPROVAL FOR A CHANGE IN THE ALLOWABLE EXPOSURE LIMIT FOR THE BATTERY AND CAPACITOR AT THE FINAL DEVICE MANUFACTURING SITE.
P990064|S016|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSIAC PORCINE BIOPROSTHESIS, MODELS 305, 310|DYE|CV|30-Day Notice||N|08/03/2006|09/01/2006|||OK30|CHANGE TO THE SUPPLIER OF THE PLOYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.
P980035|S060|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM (IPG)|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2006|01/24/2007|||APPR|APPROVAL FOR A CHANGE IN THE ALLOWABLE EXPOSURE LIMIT FOR THE BATTERY AND CAPACITOR AT THE FINAL DEVICE MANUFACTURING SITE.
P970031|S017|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS|LWR|CV|30-Day Notice||N|08/03/2006|09/01/2006|||OK30|CHANGE TO THE SUPPLIER OF THE PLOYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.
P910023|S115|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/04/2006|09/18/2006|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS TO ADD SUPPORT FOR ATLAS II AND EPIC II ICD FAMILIES AND TO REMOVE THE SURFACE ECG FUNCTION.
P010050|S005|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE / IMMULITE 1000 HBSAG & IMMULITE 2000 HBSAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2006|09/01/2006|||OK30|CHANGE TO THE REAGENT MANUFACTURING PROCESS.
P040021|S003|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/2006|05/25/2007|||APPR|APPROVAL FOR THE ADDITION OF THE 29MM BIOCOR AORTIC VALVE; ADDITION OF SIZES 25MM AND 27MM BICOR SUPRA AORTIC VALVE; A CHANGE IN THE PACKAGE SOLUTION CONCENTRATION; A REDUCED PRE-IMPLANT RINSE TIME; A CHANGE IN THE VALE HOLDER AND HOLDER HANDLE DESIGNS; AND ADDITIONAL HEMODYNAMIC DATA FOR THE 27MM BIOCOR MITRAL VALVE.
P970053|S010|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/2006|11/08/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM (MODEL CXII) INCLUDING A REDUCTION IN SIZE, THE STANDARDIZATION OF PREVIOUSLY OPTIONAL FEATURES, INCORPORATING THE CONTROL COMPUTER INTO THE COMPUTER (PREVIOUSLY STAND-ALONE) AND REPLACING THE ORIGINAL (MANUAL MAGNIFICATION) MICROSCOPE WITH A NEW MODEL WITH MOTORIZED MAGNIFICATION CONTROL.  THE NEW DEVICE WILL BE NAMED THE NIDEK EC-5000 EXCIMER LASER SYSTEM MODEL CXIII.
P000044|S014|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2006|09/06/2006|||OK30|ADDITION OF A RAW MATERIAL SPECIFICATION, THE MODIFICATION OF A RAW MATERIAL SPECIFICATION, AND THE MODIFICATION OF A COMPONENT RELEASE SPECIFICATION.
P010029|S004|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA|MOZ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/18/2006|08/23/2007|||APPR|APPROVAL FOR A CHANGE IN INFLAMMATION TESTING FOR BULK SODIUM HYALURONATE FROM OXIDATIVE BURST TESTING TO AN IL-6 ELISA METHOD.
P960011|S011|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BIOLON 1% SODIUM HYALURONATE|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/18/2006|09/13/2007|||APPR|APPROVAL FOR A CHANGE IN INFLAMMATION TESTING FOR BULK SODIUM HYALURONATE FROM OXIDATIVE BURST TESTING TO AN IL-6 ELISA METHOD.
P050044|S001|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2006|01/25/2007|||APPR|APPROVAL FOR REVISED CELLPAKER MANUFACTURE BY SPECIAL TEAM MEDICAL SERVICES (YORBA LINDA, CALIFORNIA), TERMINAL STERILIZATION OF THE CELLPAKER BY STERIGENICS US, INC. (SAN DIEGO, CALIFORNIA), AND CHANGE IN CONTRACTOR PERFORMING THE LIMULUS AMEBOCYTE LYSATE ASSAY TO LEXAMED, LTD (TOLEDO, OHIO).
P040013|S006|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENHANCED MATRIX|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2006|09/08/2006|||OK30|SCALING UP THE MANUFACTURING PROCESS TO MOVE FROM 2,000 UNIT BATCHES TO 20,000 UNIT BATCHES.
P010030|S008|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WCD 3000|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/11/2006|10/31/2007|||APPR|APPROVAL FOR A CHANGE IN THE BATTERY PACK PCA ARTWORK, ADDITION OF 100-OHM RESISTOR AT U3 PIN 1, AND A CHANGE OF THE DOUBLE-SIDED PRESSURE SENSITIVE ADHESIVE (PSA) TAPE.
P020036|S005|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2006|09/07/2006|||OK30|CHANGE IN ACCEPTANCE CRITERIA OF A QUALITY ASSURANCE INSPECTION FOR THE DEVICE.
P040037|S002|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/2006|02/08/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE ENDOPROSTHESIS AND DELIVERY CATHETER DESIGN TO REDUCE THE OVERALL DELIVERY PROFILE OF THE DEVICE BY ONE FRENCH SIZE.
P810031|S028|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2006|09/14/2006|||OK30|CHANGE TO AN AUTOMATED PROCESS FOR THE PRE-TREATMENT OF THE GLASS VIALS CONTAINING THE VISCOELASTIC MATERIAL.
P810031|S029|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2006|09/13/2006|||OK30|REVISION OF THE INTRINSIC VISCOSITY TEST METHOD FOR THE SODIUM HYALURONATE (5000, 7000) AND RELATED PRODUCTS.
P810031|S030|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2006|09/13/2006|||OK30|RELOCATION OF A QUALITY CONTROL LABORATORY USED FOR INCOMING INSPECTION OF RAW MATERIALS (EXCEPT SODIUM HYALURONATE) AND PACKAGING COMPONENTS FOR HEALON PRODUCTS TO A DIFFERENT BUILDING AT THE SAME MANUFACTURING SITE IN THE UPPSALA, SWEDEN FACILITY.
P980037|S019|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|XMI AND XMI-RX THROMBECTOMY CATHETERS|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2006|02/02/2007|||APPR|APPROVAL FOR A CHANGE IN SEQUENCE FOR THE COATING APPLICATION OF THE CATHETER ASSEMBLY.
P060003|S001|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2006|09/11/2006|||OK30|IMPLEMENTATION OF ADDITIONAL TESTING AT TWO DIFFERENT STAGES IN THE MANUFACTURING PROCESS.
P000006|S007|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/2006|06/13/2008|||APPR|APPROVAL FOR: 1) REVISION OF THE CURRENT TITAN PROSTHESIS TO INCLUDE A NEW ONE-TOUCH RELEASE PUMP BODY; 2) ADDITION OF NUSIL TECHNOLOGY MED-4755 SILICONE AS AN OPTIONAL ALTERNATIVE TO THE CURRENTLY USED NUSIL TECHNOLOGY MED-4515 AND MED-4750 SILICONES; 3) ADDITION OF A 1.5CM REAR TIP EXTENDER IN THE TITAN ASSEMBLY KITS; 4) ADDITION OF A SPECIFICATION IMPOSING A LOWER LIMIT OF 2.5 LB FOR TACTILE FORCE FOR DEFLATION USING THE OTR PUMP; AND 5) LABELING REVISIONS RELATING TO THE ABOVE DEVICE CHANGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TITAN OTR INFLATABLE PENILE PROSTHESIS AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.
P960052|S012|CLOSURE MEDICAL CORP.|5265 CAPITAL BLVD.||RALEIGH|NC|27616||Tissue adhesive for the topical approximation of skin|DERMABOND TOPICAL SKIN ADHESIVE|MPN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2006|09/14/2006|||OK30|CHANGE TO THE STERILIZATION PROCESS.
P880086|S126|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/ENTITY/IDENTITY ADX/INTREGRITY/INTEGRITY MICRO/VERITY ADX PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2006|12/21/2006|||APPR|APPROVAL FOR ALTERNATIVE TANTALUM CAPACITORS.
P030035|S019|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER BIVENTRICULAR PACEMAKERS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2006|12/21/2006|||APPR|APPROVAL FOR ALTERNATIVE TANTALUM CAPACITORS.
P960013|S022|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/17/2006|10/10/2006|||APPR|APPROVAL FOR THE LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS, MODELS 1281, 1282, 1283, 1291, 1292 AND 1293.  THE LOCATOR PLUS STYLETS ARE SIMILAR TO THE APPROVED LOCATOR MODEL 4036 STEERABLE STYLET (PMA P960013/S010), BUT WITH SIX DIFFERENT COMBINATIONS OF TIP RADII AND STRAIGHT TIP LENGTHS.  THE LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS ARE INTENDED FOR USE WHEN IMPLANTING COMPATIBLE ST. JUDE MEDICAL ACTIVE FIXATION STRAIGHT ENDOCARDIAL PACEMAKER LEADS, TENDRIL MODEL 1688 SDX AND HIGHER.
P950029|S027|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY & ELA RHAPSODY DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2006|09/15/2006|||OK30|CHANGE IN THE FLUX USED FOR SOLDER REWORK.
P950029|S028|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY 2550 AND 2250 & RHAPSODY 2530, 2510 AND 2210|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2006|09/15/2006|||OK30|CHANGE FROM CLEANING WITH THE KERRY MACHINE TO CLEANING WITH THE MBTECH MACHINE, AND THE ADDITION OF AN MBTECH CLEANING STEP AND VISUAL INSPECTION STEP.
P870076|S008|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|ACMI FALOPE RING BAND|KNH|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2006|05/24/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GYRUS ACMI CORPORATION, MAPLE GROVE MINNESOTA TO MANUFACTURE THE FALOPE RING BAND AND THE FALOPE RING BAND DISPOSABLE APPLICATOR KITS.
P040042|S005|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/2006|10/03/2006|||APPR|APPROVAL FOR THE ADDITION OF AN ADAPTER CABLE, 1739-W, TO ALLOW THE THERAPY DUAL 8 CATHETER TO BE USED WITH THE BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR, APPROVED UNDER P990071.
P920047|S035|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/21/2006|12/01/2006|||APPR|APPROVAL FOR THE ADDITION OF A CHOKE IN THE XP APM WHICH WILL ELIMINATE THE DELIVERY OF THE RF ENERGY WHERE THE USER FAILED TO CONNECT OR IMPROPERLY CONNECTED THE DISPERSIVE INDIFFERENT PATCH (DIP) ELECTRODES TO THE PATIENT.
P030026|S011|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HBC IGM REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2006|09/12/2006|||OK30|CHANGE IN THE ASSESSMENT OF COATED WELL PLATES FOR STREPTAVIDIN.
P830055|S098|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|MBT TIBIAL TRAY|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2006|03/13/2007|||APPR|APPROVAL FOR AUTOMATING, VIA THE USE OF A MAZAK 410-A VERTICAL MILL, AND EXISTING MANUAL STEP FOR FINISHING THE ZONE 6 OUTER PROFILE OF THE MBT TIBIAL  TRAY.
P050012|S003|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SHORT TERM GLUCOSE SENSOR (STS)|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2006|09/01/2006|||OK30|RELEASE CRITERIA MODIFICATION TO THE METHOD USED FOR FINAL RELEASE CRITERIA OF THE DEXCOM STS SENSOR.
P860057|S037|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS 3000, 3000TFX(AORTIC), 6900P & 6900PTFX(MITRAL)|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/25/2006|02/08/2007|||APPR|APPROVAL FOR A REDUCTION IN THE STITCH DENSITY OF THE ANCHOR STITCH SEAMLINE AND FINAL ALTERNATING STITCH SEAMLINE PROCESS OF THE BIOPROSTHETIC STENT SUBASSEMBLY.
P890003|S108|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MODEL 2490H MEDTRONIC CARELINK MONITOR & MODEL 2020A CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|08/21/2006|09/19/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA FOR THE FINAL TESTING, ACTIVATING, LABELING AND PACKAGING OF THE MODEL 2490H CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER.
P980035|S061|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|08/21/2006|09/19/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA FOR THE FINAL TESTING, ACTIVATING, LABELING AND PACKAGING OF THE MODEL 2490H CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER.
P980016|S083|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SELECTED FAMILIES OF ICDS|LWS|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|08/21/2006|09/19/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA FOR THE FINAL TESTING, ACTIVATING, LABELING AND PACKAGING OF THE MODEL 2490H CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER.
P010031|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS INSYNC FAMILIES OF CRT-ICDS|NIK|CV|Normal 180 Day Track No User Fee|Express GMP Supplement|N|08/21/2006|09/19/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA FOR THE FINAL TESTING, ACTIVATING, LABELING AND PACKAGING OF THE MODEL 2490H CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER.
P000039|S017|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|30-Day Notice||N|08/22/2006|09/15/2006|||OK30|CHANGE TO THE LAL SAMPLING PLAN.
P020024|S012|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2006|09/15/2006|||OK30|CHANGE TO THE LAL SAMPLING PLAN.
P990019|S004|DUSA PHARMACEUTICALS, INC.|25 UPTON DR.||WILMINGTON|MA|01887||SYSTEM, LASER, PHOTODYNAMIC THERAPY|BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR|MVF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2006|09/21/2006|||OK30|USE OF AN ALTERNATE MANUFACTURER FOR THE TIMER ASSEMBLY IN THE DEVICE.
P010019|S004|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/22/2006|09/20/2006|||APPR|APPROVAL FOR REVISED STABILITY PROTOCOLS.
P820021|S031|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/22/2006|09/20/2006|||APPR|APPROVAL FOR REVISED STABILITY PROTOCOLS.
P040033|S001|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2006|10/13/2006|||APPR|APPROVAL FOR: 1) ADDITION OF INTERMEDIATE SIZED FEMORAL HEAD COMPONENTS TO THE BHR SYSTEM (40MM, 44MM, 48MM, 52MM AND 56MM);  2) ADDITION OF ACETABULAR CUPS THAT MATE WITH THE INTERMEDIATE SIZED FEMORAL HEAD COMPONENTS (STANDARD, DYSPLASIA AND BRIDGING); AND 3) REVISIONS TO THE BHR LABELING TO REFLECT THE ADDITIONAL INTERMEDIATE SIZED COMPONENTS.
P040034|S007|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2006|11/02/2006|||APPR|APPROVAL FOR USE OF DATA COLLECTED AT ELEVATED TEMPERATURES (I.E., ACCELERATED AGING DATA) TO DETERMINE FUTURE SHELF LIFE CLAIMS FOR THE DEVICE, APPLYING A CORRELATION FACTOR OF Q10=3.  THE USE OF THE CORRELATION FACTOR WITH TEST DATA OBTAINED AT 35 DEGREES C COLLECTED OUT TO 26 WEEKS ACCURATELY PREDICTS PRODUCT EXPIRATION DATING TO 18 MONTHS, REAL-TIME.
P880086|S127|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SOLUS, ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, TRIOLOGY, AFFINITY, INTREGRITY, ENTITY IDENTITY, VERITY AND VICTORY PAC|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2006|09/21/2006|||OK30|CHANGE TO THE SILICONE HYDROHONE MASK TOOL USED TO MANUFACTURE THE DEVICES.
P030017|S015|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/2006|11/17/2006|||APPR|APPROVAL FOR THE IMPLANTED PULSE GENERATOR (IPG) 2.2.
P970003|S071|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/2006|10/17/2006|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN PULSE GENERATOR AND LEAD LABELING: 1) THE ADDITION OF A MANUAL ENTITLED, ?REVISION/REPLACEMENT/REMOVAL PROCEDURE MANUAL?.  2) THE INCORPORATION OF THE PHYSICIAN?S MANUAL FOR THE MODEL 303 LEAD INTO THE HARMONIZED LABELING WHICH INCLUDES THE ADDITION OF THE MODULAR PHYSICIAN?S MANUAL ENTITLED, ?TECHNICAL INFORMATION ? VNS THERAPY PERENNIA MODEL 303 LEAD?.  3) REVISIONS TO THE ?IMPLANTATION PROCEDURE? MODULE.
P980006|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION, PUREVISION TORIC AND PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2006|09/22/2006|||OK30|ALTERNATIVE AUTOMATED MANUFACTURING PROCESS.
P010031|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO MODELS C154DWK|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2006|11/15/2006|||APPR|APPROVAL FOR SOFTWARE VERSION 1.1 WHICH ADDRESSES AN ISSUE OF TEMPERATURE SENSITIVITY ON TELEMETRY.
P980016|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC VIRTUOSO MODEL D154AWG/ D154VWC IMPLANTABLE DEVICES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2006|11/15/2006|||APPR|APPROVAL FOR SOFTWARE VERSION 1.1 WHICH ADDRESSES AN ISSUE OF TEMPERATURE SENSITIVITY ON TELEMETRY.
P040016|S013|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2006|09/21/2006|||OK30|REMOVE THE SIX MINUTE DWELL TIME AFER THE PRE-SHRINK STEP FOR THE PORT PRE-ASSEMBLY PROCESS OF THE DEVICE.
P040016|S014|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2006|09/21/2006|||OK30|USE OF A MANUFACTURING FIXTURE FOR MAKING THE PORT PRE-ASSEMBLY OF THE DEVICE.
P020004|S015|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2006|09/21/2006|||OK30|CHANGE AN ACCEPTANCE CRITERIA FOR A COMPONENT USED IN THE MANUFACTURE OF THE DEVICE.
P040043|S011|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2006|09/21/2006|||OK30|CHANGE AN ACCEPTANCE CRITERIA FOR A COMPONENT USED IN HE MANUFACTURE OF THE TAG DEVICE.
P910023|S116|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|EPIC II/II + DR/VR & ATLAS II/II + DR/VR ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2006|09/21/2006|||OK30|CHANGE FROM A DELTA BATTERY VOLTAGE TEST TO A DIRECT IBAT CURRENT MEASUREMENT METHOD AND THE ELIMINATION OF A 14-DAY HOLD PERIOD DURING MANUFACTURING.
P030054|S035|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC II HF & ATLAS II HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2006|09/21/2006|||OK30|CHANGE FROM A DELTA BATTERY VOLTAGE TEST TO A DIRECT IBAT CURRENT MEASUREMENT METHOD AND THE ELIMINATION OF A 14-DAY HOLD PERIOD DURING MANUFACTURING.
P990081|S004|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY HER-2/NEU (CLONE CB11) PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2006|09/05/2006|||OK30|CHANGE TO ELIMINATE THE REQUIREMENT FOR FINAL ACCEPTANCE TESTING OF ANTI-C-ERBB-2 (CLONECB11) ON TWO INSTRUMENT SYSTEMS.
P000039|S018|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2006|03/01/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AGA MEDICAL CORPORATION, PLYMOUTH, MINNESOTA.
P020024|S013|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2006|03/01/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AGA MEDICAL CORPORATION, PLYMOUTH, MINNESOTA.
P950029|S029|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|RHAPSODY MODELS 2210, 2510 AND 2530 PACEMAKERS; SYMPHONY MODELS 2250 AND 2550 PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2006|09/22/2006|||APPR|APPROVAL FOR A COUNTERBORE BEING ADDED TO THE CERAMIC INSULATOR TO ACCOMMODATE THE BRAZED GOLD FOR EACH FEEDTHROUGH WIRE.
P860057|S038|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2006|01/29/2007|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD.
P990004|S010|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/30/2006|10/03/2006|||APPR|APPROVAL FOR AN ORAL SURGERY FORM OF SURGIFOAM ABSORBABLE GELATIN SPONGE, USP.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE AND IS INDICATED FOR USE AS AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES.
P870056|S024|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2006|01/29/2007|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD.
P910061|S015|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|LI61AO LENS|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/30/2006|12/06/2006|||APPR|APPROVAL TO ADD A STATEMENT TO THE DIRECTIONS FOR USE THAT THE SOFPORT MODEL LI61 AO IOL HAS PROLATE ASPHERIC SURFACES AND IS DESIGNED TO BE FREE OF SPHERICAL ABERRATIONS, AND TO ADD A FIGURE WITH THE MODULATION TRANSFER FUNCTIONS FOR THE LI61AO AND LI61SE LENSES.
P870077|S022|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2006|01/29/2007|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD.
P000007|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2006|01/29/2007|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD.
P010041|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2006|01/29/2007|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD.
P990033|S008|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2006|10/05/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, US, LLC, QUEENSBURY, NEW YORK, TO PERFORM THE ETHYLENE OXIDE STERILIZATION.
P870038|S009|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2006|01/29/2007|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD.
P910066|S022|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATOR|LOF|OR|Normal 180 Day Track No User Fee|Express GMP Supplement|N|08/31/2006|10/13/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN VISTA, CALIFORNIA.
P040016|S015|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|08/31/2006|09/21/2006|||OK30|ALTERNATE METHOD FOR REMOVAL OF THE DISTAL HEAT SHRINK MANUFACTURING AID OF THE DEVICE.
P030025|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2006|09/21/2006|||OK30|ALTERNATE METHOD FOR REMOVAL OF THE DISTAL HEAT SHRINK MANUFACTURING AID OF THE DEVICE.
P020009|S028|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MR & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|08/31/2006|09/21/2006|||OK30|ALTERNATE METHOD FOR REMOVAL O THE DISTAL HEAT SHRINK MANUFACTURING AID OF THE DEVICE.
P040016|S016|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2006|12/11/2006|||APPR|APPROVAL FOR A HEAT SHRINK CHANGE FOR THE PROXIMAL AND MIDSHAFT WELDS.
P030025|S035|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2006|12/11/2006|||APPR|APPROVAL FOR A HEAT SHRINK CHANGE FOR THE PROXIMAL AND MIDSHAFT WELDS.
P020009|S029|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2006|12/11/2006|||APPR|APPROVAL FOR A HEAT SHRINK CHANGE FOR THE PROXIMAL AND MIDSHAFT WELDS.
P000039|S019|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|09/01/2006|08/16/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE POST APPROVAL STUDY.
N18033|S040|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) W/UV BLOCKER|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2006|10/31/2006|||APPR|APPROVAL FOR ADDING POLYVINYLPYRROLI-DONE (PROVIDONE) TO THE PACKING SOLUTION FOR THE DEVICE.
P040014|S004|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETERS|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/2006|01/10/2007|||APPR|APPROVAL FOR 1) THE ADDITION OF THERMISTOR TEMPERATURE SENSOR CATHETERS TO THE THERAPY CATHETER MODEL MIX, 2) THE ADDITION OF A 1763-E COMPATIBLE INTERFACE CABLE TO THE 4MM THERMISTOR ABLATION CATHETER, AND 3) THE ADDITION OF THE 1778-E COMPATIBLE INTERFACE CABLE TO THE 8MM THERMISTOR ABLATION CATHETER.
P040042|S006|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/2006|01/10/2007|||APPR|APPROVAL FOR 1) THE ADDITION OF THERMISTOR TEMPERATURE SENSOR CATHETERS TO THE THERAPY CATHETER MODEL MIX, 2) THE ADDITION OF A 1763-E COMPATIBLE INTERFACE CABLE TO THE 4MM THERMISTOR ABLATION CATHETER, AND 3) THE ADDITION OF THE 1778-E COMPATIBLE INTERFACE CABLE TO THE 8MM THERMISTOR ABLATION CATHETER.
P000029|S019|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2006|04/26/2007|||APPR|APPROVAL FOR TWO NEW WATER SYSTEMS (FOR THE PRODUCTION OF PURIFIED WATER (PW) AND FOR WATER FOR INJECTION (WFI)) AND THE EQUIPMENT FOR THE PRODUCTION, STORAGE AND DISTRIBUTION OF PW AND WFI.
P950039|S017|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/05/2006|10/05/2006|||APPR|APPROVAL FOR LABELING CHANGES REGARDING WARNING AND HANDLING/DISPOSAL INSTRUCTIONS FOR THINPREP 2000 PROCESSORS THAT HAVE BEEN CONTAMINATED WITH TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE).
P060003|S002|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2006|10/04/2006|||OK30|IMPLEMENTATION OF ADDITIONAL IN-PROCESS TESTING.
P000015|S008|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI)|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2006|10/05/2006|||OK30|ADDITIONAL ETHYLENE OXIDE (EO) STERILIZER AND CHANGE TO A NEW SIZE OF ETHYLENE OXIDE CANISTER.
P970051|S039|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2006|10/05/2006|||OK30|ADDITIONAL ETHYLENE OXIDE (EO) STERILIZER AND CHANGE TO A NEW SIZE OF ETHYLENE OXIDE CANISTER.
P040052|S002|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|MONOPREP PAP TEST|MKQ|PA|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|09/05/2006|05/25/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P050012|S004|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SHORT TERM GLUCOSE SENSOR (STS)|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|09/22/2006|||OK30|MODIFICATION OF THE APPLICATION PROCESS TO ONE OF THE LAYERS IN TE MULTI-LAYER MEMBRANE SYSTEM.
P880086|S128|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VARIOUS MODELS OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|09/29/2006|||OK30|CHANGE FROM AN ION MILLING PROCESS TO A WET ETCH REMOVAL PROCESS.
P040016|S017|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|10/06/2006|||OK30|CHANGE TO A PAPERLESS LASER INFORMATION SYSTEM.
P030025|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|10/06/2006|||OK30|CHANGE TO A PAPERLESS LASER INFORMATION SYSTEM.
P020009|S030|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|10/06/2006|||OK30|CHANGE TO A PAPERLESS LASER INFORMATION SYSTEM.
P030035|S020|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|09/29/2006|||OK30|CHANGE FROM AN ION MILLING PROCESS TO A WET ETCH REMOVAL PROCESS.
P030036|S002|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC SELECTSECURE LEAD MODEL 3830|NVY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/2006|10/11/2006|||APPR|APPROVAL FOR A LABEL CHANGE TO THE TECHNICAL MANUAL FOR THE SELECTSECURE LEAD MODEL 3830.
P910023|S117|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|EPIC II/II + DR/VR AND ATLAS II/II + DR/VR ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|10/06/2006|||OK30|ALTERNATE VENDOR FOR THE SUPPORT ASSEMBLY.
P910023|S118|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC, ATLAS, EPIC II, AND ATLAS II ICD FAMILIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|09/29/2006|||OK30|CHANGE FROM AN ION MILLING PROCESS TO A WET ETCH REMOVAL PROCESS.
P030054|S036|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST. JUDE MEDICAL EPIC HF, ATLAS + HF, EPIC II HF AND ATLAS II HF CRT-D FAMILIES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|09/29/2006|||OK30|CHANGE FROM AN ION MILLING PROCESS TO A WET ETCH REMOVAL PROCESS.
P030054|S037|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC II HF & ATLAS II HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2006|10/06/2006|||OK30|ALTERNATE VENDOR FOR THE SUPPORT ASSEMBLY.
P910018|S012|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/08/2006|03/31/2009|||APPR|APPROVAL FOR THE LIPOSORBER LA-15 SYSTEM USING THE MA-03 APHERESIS MACHINE AND THE BLOOD TUBING SYSTEMS; NK-M3R AND NK-M1R.
P020016|S002|BIOMET MICROFIXATION, INC.|1520 TRADEPORT DR.||JACKSONVILLE|FL|32218||Joint, temporomandibular, implant|TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM|LZD|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2006|10/13/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ARTHROTEK, INC.?S ONTARIO CALIFORNIA, FACILITY FOR  THE PURCHASE OF RAW MATERIAL FOR THE MANDIBULAR BLANKS; THE CUTTING OF THIS RAW MATERIAL; AND THE ADDITION OF ANOTHER WIRE ELECTRICAL DISCHARGE MACHINE.
P010012|S139|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK IS-1 AND EASYTRAK LV-1 LEADS|LWP|CV|Normal 180 Day Track No User Fee|Other Report|N|09/11/2006|03/06/2007|||APPR|APPROVAL FOR ADDING POST APPROVAL STUDY (PAS) DATA TO THE EASYTRAK IS-1 AND EASYTRAK LV-1 PHYSICIAN MANUALS.
P050023|S001|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS/CRT-DS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/2006|12/07/2006|||APPR|APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF  ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE.
P950037|S046|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|NVZ|CV|Normal 180 Day Track||N|09/11/2006|12/07/2006|||APPR|APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF  ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE.
P000009|S020|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS/CRT-DS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/2006|12/07/2006|||APPR|APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF  ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE.
P980023|S025|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LUMAX FAMILY OF ICDS/CRT-DS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/2006|12/07/2006|||APPR|APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF  ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE.
P880086|S129|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ST JUDE MEDICAL IDENTITY, VERITY, INTEGRITY, VICTORY & AFFINITY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2006|10/12/2006|||OK30|ALTERNATE SUPPLIER FOR THE ?L? CONNECTOR SUB-ASSEMBLY.
P050006|S001|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/12/2006|09/21/2007|||APPR|APPROVAL FOR DESIGN MODIFICATIONS FOR THE CATHETER DELIVERY SYSTEM (HELIX 1.5 DELIVERY SYSTEM).
P980040|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|10/18/2006|||OK30|CHANGE TO CLEAN ROOM SPECIFICATIONS TO IMPROVE EFFICIENCY, ENVIRONMENTAL SPECIFICATIONS AND MODIFICATIONS, AND CONTINUOUS PRODUCT FLOW.
P880086|S130|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VICTORY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|10/13/2006|||OK30|ADDING A TEST TO THE IC WAFER PROBE TEST SUITE FOR VICTORY AND FRONTIER II DEVICES.
P030035|S021|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER II CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|10/13/2006|||OK30|ADDING A TEST TO THE IC WAFER PROBE TEST SUITE FOR VICTORY AND FRONTIER II DEVICES.
P030025|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXE-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|09/29/2006|||OK30|REMOVAL OF THE SIX MINUTE DWELL TIME BETWEEN THE PRE-SHRINK AND PORT WELD STEPS OF THE PORT PRE-ASSEMBLY PROCESS.
P020009|S031|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|09/29/2006|||OK30|REMOVAL OF THE SIX MINUTE DWELL TIME BETWEEN THE PRE-SHRINK AND PORT WELD STEPS OF THE PORT PRE-ASSEMBLY PROCESS.
P860019|S212|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|09/29/2006|||OK30|REMOVAL OF THE SIX MINUTE DWELL TIME BETWEEN THE PRE-SHRINK AND PORT WELD STEPS OF THE PORT PRE-ASSEMBLY PROCESS.
P030025|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|10/03/2006|||OK30|USE OF A MANUFACTURING FIXTURE IN THE PORT PRE-ASSEMBLY PROCESS.
P020009|S032|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2  CORNARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|10/03/2006|||OK30|USE OF A MANUFACTURING FIXTURE IN THE PORT PRE-ASSEMBLY PROCESS.
P860019|S213|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2006|10/03/2006|||OK30|USE OF A MANUFACTURING FIXTURE IN THE PORT PRE-ASSEMBLY PROCESS.
P870072|S035|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|TLC-II PORTABLE VAD DRIVER|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/2006|01/21/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE TLC-II PORTABLE VAD DRIVER, INCLUDING THE ADDITION OF A SCROLL COMPRESSOR, ELECTRONIC RVAD PRESSURE REGULATOR, LONGER PNEUMATIC LEADS REMOVAL OF CONTRAINDICATION AGAINST PATIENTS REQUIRING HIGH RVAD DRIVER PRESSURES AND/OR LONG EJECTION TIMES, AND ASSOCIATED HARDWARE AND SOFTWARE CHANGES.
P040021|S004|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||replacement Heart-valve|SJM EPIC VALVE AND SJM EPIC SUPRA VALVE|DYE|CV|Panel Track|Change Design/Components/Specifications/Material|N|09/29/2006|11/15/2007|08M-0084|02/05/2008|APPR|APPROVAL FOR THE EPIC VALVE IN AORTIC SIZES 21, 23, 25, 27 AND 29 MM, AND IN MITRAL SIZES 27, 29, 31 AND 33 MM, AND THE SJM EPIC SUPRA VALVE IN AORTIC VALVE SIZES 19, 21, 23, 25 AND 27 MM.  THE DEVICE IS INDICATED FOR PATIENTS REQUIRING REPLACEMENT OF A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE AORTIC AND/OR MITRAL HEART VALVE.  IT MAY ALSO BE USED AS A REPLACEMENT FOR A PREVIOUSLY IMPLANTED AORTIC AND/OR MITRAL PROSTHETIC HEART VALVE.
P970058|S024|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY|MYN|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2006|02/09/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT HOLOGIC, INC., BEDFORD, MASSACHUSETTS.
N12159|S021|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL / SURGICEL NU-KNIT / SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2006|10/13/2006|||OK30|CHANGE OF THE PACKAGING FROM PECHINEY MARAFLEX #5269 TO PECHINEY M-1332 AND AMCOR LPS-451.
P850020|S024|FRESENIUS HEMOCARE, INC.|920 WINTER STREET||WALTHAM|MA|02451||Separator for therapeutic purposes, membrane automated blood cell/plasma|PROSORBA COLUMN|MDP|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/2006|10/19/2006|||APPR|APPROVAL FOR LABELING CHANGES TO ADD 1) CAUTION AND PRECAUTION STATEMENTS RELATING TO THE RISK OF THROMBOSIS, 2) A CLARIFICATION REGARDING TREATMENT VOLUMES FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS, 3)  A CLARIFICATION THAT ITP, AS WELL AS RHEUMATOID  ARTHRITIS, PATIENTS MAY NOT FEEL THE EFFECTS OF PROSORBA TREATMENTS IMMEDIATELY AFTER INITIATION OF THERAPY, AND 4) A CLARIFICATION THAT TREATMENTS SHOULD BEGIN WITHIN ONE HOUR OF PRIMING.
P020018|S011|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2006|07/01/2008|||APPR|APPROVAL OR THE: 1) ADDITION OF AN AUTOMATED LASER WELDING PROCESS; AND 2) REMOVAL OF THE SUBSEQUENT ULTRASONIC CLEANING STEP FROM THE SOLDERING PROCESS.
P020018|S013|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONESHOT INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2006|10/17/2006|||OK30|TRANSFER THE CUTTING, SANDBLASTING, AND CHAMFERING STEPS USED TO MANUFACTURE THE THREADED CANNULA (A COMPONENT OF THE H&L-B ONE-SHOT INTRODUCTION SYSTEM) FROM COOK, INC. TO AN OUTSIDE VENDOR.
P020018|S014|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2006|10/17/2006|||OK30|ALLOWING THE INTERNAL AND EXTERNAL THREADS OF THE DILATOR TIP (A COMPONENT OF THE H&L-B ONE-SHOT INTRODUCTION SYSTEM) TO BE MACHINED BY AN OUTSIDE VENDOR.
P020018|S015|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2006|10/18/2006|||OK30|ASSEMBLY OF RAW MATERIAL KITS TO FACILITATE CONSTRUCTION OF LEG EXTENSION GRAFT SUBASSEMBLIES, AND TO ALLOW LEG EXTENSION GRAFT SUBASSEMBLIES TO BE PRODUCED BY A CONTRACT MANUFACTURER.
P020018|S016|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2006|08/30/2007|||APPR|APPROVAL FOR THE ADDITION OF ALTERNATE VENDORS FOR 1) THE 5-0 GREEN BRAIDED POLYESTER SUTURE AND 2) THE 5-0 BLUE MONOFILAMENT POLYPROPYLENE SUTURE.
P010012|S140|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 3 IS-1 & LV-1 HEART FAILURE LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2006|10/17/2006|||OK30|ADDING AN ACCEPTANCE ACTIVITY TO THE MANUFACTURING PROCESS.
P960028|S015|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2006|10/20/2006|||OK30|CHANGE TO AN AUTOMATIC CORING FIXTURE FOR SILICONE INTRAOCULAR LENS LOOP INSERTION.
P910071|S009|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL|LWL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2006|09/12/2007|||APPR|APPROVAL TO CHANGE MOLDING TECHNOLOGY.
P040001|S003|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP IPD SYSTEM|NQO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2006|10/19/2006|||OK30|CHANGES IN PACKAGING FOOTPRINT, PACKAGING PROCESSES, LABELING PROCESSES AND MANUFACTURING FLOW FOR THE DEVICE.
P950020|S019|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON MONORAIL|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2006|10/19/2006|||OK30|CHANGE IN THE STERILITY DOSE AUDIT PROCEDURES FROM VD MAX TO METHOD 1, WITH CORRESPONDING CHANGES IN MINIMUM RADIATION STERILIZATION DOSE AND THE NUMBER OF QUARTERLY STERILIZATION DOSE AUDITS.
P040023|S008|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/2006|10/18/2006|||APPR|APPROVAL FOR CHANGES TO THE WARNINGS AND PRECAUTIONS SECTION OF THE PACKAGE INSERT LABELING TO INCLUDE ADDITIONAL STATEMENTS THAT ADVISE THE SURGEON TO AVOID THE TAPER REGION AND SHELL FACE OF THE METAL ACETABULAR SHELL COMPONENT WHEN IMPACTING THE SHELL TO ADJUST THE POSITION OF THE COMPONENT.
P860019|S214|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2006|10/13/2006|||OK30|ADDITION OF AN ALTERNATIVE METHOD FOR REMOVING THE HEAT SHRINK AID.
P920047|S036|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2006|12/21/2006|||APPR|APPROVAL FOR MODIFICATION OF THE STEERING MECHANISM FOR THE N4 CURVE VERSION OF THE BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER AND THE USE OF A NEW SOLDERING FIXTURE IN THE MANUFACTURING PROCESS.
P020025|S018|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CATHETERS|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2006|12/21/2006|||APPR|APPROVAL FOR MODIFICATION OF THE STEERING MECHANISM FOR THE N4 CURVE VERSION OF THE BLAZER II XP CATHETERS AND THE USE OF A NEW SOLDERING FIXTURE IN THE MANUFACTURING PROCESS.
P860019|S215|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2006|10/20/2006|||OK30|CHANGE THE LASER WATTAGE AND BEAM SPLIT RATIO FOR THE MAVERICK PTCA CATHETERS.
P030025|S039|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice||N|09/21/2006|02/12/2007|||APPR|APPROVAL TO ADD AN AUTOMATED STENT INSPECTION STEP FOR THE STENT COMPONENT OF THE DEVICE.
P040016|S018|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2006|02/12/2007|||APPR|APPROVAL TO ADD AN AUTOMATED STENT INSPECTION STEP FOR THE STENT COMPONENT OF THE DEVICE.
P020009|S033|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice||N|09/21/2006|02/12/2007|||APPR|APPROVAL TO ADD AN AUTOMATED STENT INSPECTION STEP FOR THE STENT COMPONENT OF THE DEVICE.
P000043|S016|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATRX OFFICE THERMO THERAPY|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2006|10/13/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MRI MANUFACTURING AND RESEARCH, INC., TUCSON, ARIZONA TO CONDUCT PACKAGING AND LABELING FOR THE RX-200 APPLICATOR (CATHETER).
P060007|S001|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG AND HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2006|10/18/2006|||OK30|ADDITION OF SPECIFICATIONS, THE MODIFICATION OF SPECIFICATIONS, AND ADDITIONAL TESTING DURING THE MANUFACTURING PROCESS.
P880086|S131|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|INDENTITY, VERITY, INTEGRITY & VICTORY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2006|10/13/2006|||OK30|ALTERNATE ENCAPSULATION MATERIAL USED IN PACEMAKER HYBRID ASSEMBLIES.
P030035|S022|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER II PACEMAKERS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2006|10/13/2006|||OK30|ALTERNATE ENCAPSULATION MATERIAL USED IN PACEMAKER HYBRID ASSEMBLIES.
P040021|S005|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|09/20/2006|11/14/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P000007|S012|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2006|01/18/2007|||APPR|APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
P860057|S039|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PERIMOUNT PERICARDIAL BIOPROSTHESES|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2006|01/18/2007|||APPR|APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
P870056|S025|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|BIOPROSTHESIS MODEL 2625,6625, VALVED CONDUIT MODEL 4300|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2006|01/18/2007|||APPR|APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
P870077|S023|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|DURAFLEX LOW PRESSURE BIOPROSTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2006|01/18/2007|||APPR|APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
P010041|S012|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODELS 2650,6650|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2006|01/18/2007|||APPR|APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
P870038|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|SILASTIC BALL HEART VALVE PROSTHESIS|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2006|01/18/2007|||APPR|APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
P990066|S025|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2006|10/20/2006|||OK30|ADDITION OF GE HEALTHCARE/FINLAND AS AN ALTERNATE SUPPLIER FOR THE X-RAY BUCKYS USED ON THE DEVICE.
P030047|S001|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM|NIM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/27/2006|11/16/2006|||APPR|APPROVAL FOR THE PRECISE? RX NITINOL STENT SYSTEM.
P030054|S039|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2006|10/25/2006|||OK30|AUTOMATION OF DOWNLOADING MERLIN PREFERENCE FILES THROUGH THE FINAL SOFTWARE UPDATE PROCESS.
P030035|S023|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2006|10/25/2006|||OK30|AUTOMATION OF DOWNLOADING MERLIN PREFERENCE FILES THROUGH THE FINAL SOFTWARE UPDATE PROCESS.
P830045|S102|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON/PHOENIX FAMILY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2006|10/25/2006|||OK30|AUTOMATION OF DOWNLOADING MERLIN PREFERENCE FILES THROUGH THE FINAL SOFTWARE UPDATE PROCESS.
P880006|S045|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2006|10/25/2006|||OK30|AUTOMATION OF DOWNLOADING MERLIN PREFERENCE FILES THROUGH THE FINAL SOFTWARE UPDATE PROCESS.
P880086|S132|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2006|10/25/2006|||OK30|AUTOMATION OF DOWNLOADING MERLIN PREFERENCE FILES THROUGH THE FINAL SOFTWARE UPDATE PROCESS.
P910023|S120|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2006|10/25/2006|||OK30|AUTOMATION OF DOWNLOADING MERLIN PREFERENCE FILES THROUGH THE FINAL SOFTWARE UPDATE PROCESS.
P970013|S012|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY PACEMAKERS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2006|10/25/2006|||OK30|AUTOMATION OF DOWNLOADING MERLIN PREFERENCE FILES THROUGH THE FINAL SOFTWARE UPDATE PROCESS.
P970043|S026|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||Excimer laser system|LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE|LZS|OP|Real-Time Process||N|09/28/2006|11/01/2006|||APPR|APPROVAL FOR A SOFTWARE CHANGE TO THE WAVEFRONT-IMAGE GATHERING SEQUENCE IN THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE TO ALLOW FOR DIFFERENT PRE-OP AND SURGERY DAYS; A CHANGE TO THE LADAR6000 SOFTWARE TO ALLOW FOR CONVENTIONAL CENTRATION PHOTOS TO BE IMPORTED FROM THE LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM; AND, MINOR ENHANCEMENTS/BUG FIXES TO THE LADARVISION 4000 SOFTWARE, THE LADAR6000 SYSTEM SOFTWARE, AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE.
P890055|S019|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 PUMP SILICONE CATHETER|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|09/28/2006|10/19/2006|||APPR|APPROVAL TO CHANGE THE MATERIAL OF THE THREE SILICONE BEADS ATTACHED TO THE DISTAL END OF THE PUMP CATHETER DURING MANUFACTURE TO A DIFFERENT SILICONE, NUSIL MED-4850 (SSF-MLTN-850 45-55).
P980037|S020|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/2006|03/28/2007|||APPR|APPROVAL FOR THE SPIROFLEX VG CATHETER THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM: SPIROFLEX VG RAPID EXCHANGE RHEOLYTIC THROMBECTOMY CATHETER AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SAPHENOUS VEIN GRAFT LESIONS IN VESSELS >= 3 MM IN DIAMETER PRIOR TO BALLOON ANGIOPLASTY OR STENT PLACEMENT.
N16837|S005|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2006|02/16/2007|||APPR|APPROVAL FOR CHANGES TO THE PRIMARY PACKAGE AND TO THE SHRINK SEAL.
P030025|S040|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2006|10/26/2006|||OK30|USE OF A MANUFACTURING FIXTURE FOR LOADING THE CRIMP SHEATH.
P040002|S007|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOLOGIX POWERLINK SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2006|11/01/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE CONTRALATERAL LIMB COVER/GUIDEWIRE ASSEMBLY.
P810031|S031|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2006|08/16/2007|||APPR|APPROVAL FOR THE TRANSFER AND EXPANSION OF THE QUALITY CONTROL MICROBIOLOGY LABORATORY USED FOR THE HEALON, HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES.  THE TRANSFER INCLUDES TEST METHODS, PERSONNEL, AND EQUIPMENT FROM BUILDING 16  TO BUILDING 23 LOCATED IN UPPSALA, SWEDEN.
P930016|S025|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/29/2006|07/11/2007|07M-0288|07/20/2007|APPR|APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM.  THE DEVICE USED A 6.0 MM OPTICAL ZONE, AN 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TO ACHIEVE MONOVISION BY THE TARGETED RETENTION OF MYOPIA (-1.25 TO -2.00 D) IN THE NON-DOMINANT EYE OF PRESBYOPIC MYOPES: 1) 40 YEARS OR OLDER WHO MAY BENEFIT FROM INCREASED SPECTACLE INDEPENDENCE ACROSS A RANGE OF DISTANCES WITH USEFUL NEAR VISION; 2) WITH MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER UP TO -3.00 D, AND MINIMUM PRE-OPERATIVE MYOPIA IN THEIR NON-DOMINANT EYE AT LEAST AS GREAT AS THEIR TARGETED MYOPIA; 3) WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.50 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND 4) WITH A SUCCESSFUL PRE-OPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION EXPERIENCE.
P960013|S023|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRILL SDX LEAD MODELS 1488T/1488TC|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2006|12/05/2006|||APPR|APPROVAL FOR A NEW 3-GROOVE SUTURE SLEEVE DESIGN FOR THE TENDRIL SDX LEAD MODELS 1488T AND 1488TC.
P900009|S024|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2006|11/01/2006|||OK30|ADDITION OF SAFT AMERICA, INC., VALDESE, NORTH CAROLINA, AS A NEW CONTRACT VENDOR FOR THE MANUFACTURING OF BATTERY PACKS FOR THE REFERENCED DEVICE.
P030025|S041|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL- ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/2006|12/20/2006|||APPR|APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM 12 TO 18 MONTHS.
P860057|S040|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX|DYE|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/2006|11/08/2006|||APPR|APPROVAL FOR THE TRADE NAME CHANGE FOR THREE DEVICES, THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX, THE CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2800TFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON RSR PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2800TFX, AND THE CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL MITRAL BIOPROSTHESIS MODEL 6900PTFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL MITRAL BIOPROSTHESIS MODEL 6900PTFX.  THE INDICATIONS FOR THE THREE DEVICES REMAIN UNCHANGED.
P000008|S010|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2006|08/22/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE IN LA AURORA DE HEREDIA, COSTA RICA.
P990074|S017|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track No User Fee|Express GMP Supplement|N|10/03/2006|08/22/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE IN LA AURORA DE HEREDIA, COSTA RICA.
P890003|S109|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITORS 2490H, AND MODEL 2020A CARDIOSIGHT READER|NVZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/03/2006|10/20/2006|||APPR|APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
P980016|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC AND INTRINSIC 30 IMPLANTABLE DEVICES|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/03/2006|10/20/2006|||APPR|APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
P980035|S062|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/800/900 AND ENPULSE FAMILIES OF PACEMAKERS|NVZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/03/2006|10/20/2006|||APPR|APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
P010031|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS, INSYNC MAXIMO, INSYNC SENTRY AND INSYNC II MARQUIS|NIK|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/03/2006|10/20/2006|||APPR|APPROVAL FOR ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR.
P020018|S017|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2006|10/25/2006|||OK30|ALLOWING THE INTERNAL AND EXTERNAL THREADS OF THE DILATOR TIP (A COMPONENT OF THE H&L-B ONE-SHOT INTRODUCTION SYSTEM) TO BE MACHINED BY AN OUTSIDE VENDOR.
P050023|S002|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TUPOS LV/ATX & KRONOS LV-T CRT-DS & COROX OTW STEROID LV PACING LEAD|MRM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|10/03/2006|10/30/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P020018|S018|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2006|10/25/2006|||OK30|ALTERNATIVE METHOD TO TEMPORARILY ATTACH SELECTED EXTERNAL Z-STENTS TO THE GRAFT MATERIAL PRIOR TO PERMANENT SEWING.
P990056|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2006|10/13/2006|||APPR|APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERT WHICH INCLUDES MODIFICATION OF THE EQUIMOLARITY STATEMENT FOUND IN THE SUMMARY SECTION, ADDITION OF LOB/LOD INFORMATION AND MINOR EDITORIAL REVISIONS.
P870038|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||HEART-VALVE, MECHANICAL|STARR-EDWARDS SILASTIC BALL HEART VALVE, MODELS 1260 AND 6120|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2006|01/19/2007|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE AND CHANGE IN MATERIAL SUPPLIER.
P030054|S040|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2006|10/20/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 5.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970003|S072|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2006|11/02/2006|||OK30|REPROCESSING OF THE NCP PROGRAMMING WANDS FOR MODEL 201.
P910023|S121|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICD'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2006|10/20/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 5.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970003|S073|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2006|11/02/2006|||OK30|REPROCESSING OF THE HANDHELD COMPUTERS FOR THE VNS THERAPY SYSTEM, MODEL 250 PROGRAMMING SOFTWARE.
P880086|S133|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2006|10/20/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 5.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P830045|S103|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON/PHOENIX FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2006|10/20/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 5.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880006|S046|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2006|10/20/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 5.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970013|S013|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER MODEL 3330 VERSION 5.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2006|10/20/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 5.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030035|S024|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2006|10/20/2006|||APPR|APPROVAL FOR MODEL 3330 VERSION 5.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P980016|S086|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR/VR MODELS 7274,7230B,7230CX,7230E:MAXIMO DR/VR MODELS 7278,7232B,7232CX,7232E INTRINSIC MODELS 7288:ENTRUST D|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/10/2006|11/15/2006|||APPR|APPROVAL FOR THE DESIGN CHANGE TO ADD ALTERNATE TANTALUM CAPACITOR (XTC018) ON THE HYBRID OF THE MEDTRONIC ICDS.
P010031|S053|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS MODEL 7277LINSYNC II MARQUIS MODEL 7289; INSYNC III MARQUIS MODEL 7279,INSYNC II PROTECT MODEL 7295; UNSY|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/10/2006|11/15/2006|||APPR|APPROVAL FOR THE DESIGN CHANGE TO ADD ALTERNATE TANTALUM CAPACITOR (XTC018) ON THE HYBRID OF THE MEDTRONIC ICDS.
P970003|S074|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/10/2006|10/31/2006|||APPR|APPROVAL FOR THE ADDITION OF A PRECAUTION TO THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.6.1 AND MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.0 IN THREE DIFFERENT PLACES IN EACH OF THE RESPECTIVE MANUALS.
P900060|S037|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2006|11/03/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SORIN BIOMEDICA CARDIO S.R.L., SALUGGIA (VERCELLI), ITALY.
P810006|S024|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2006|11/08/2006|||OK30|CHANGE IN MANUFACTURING EQUIPMENT USED IN THE COLLAGEN PURIFICATION PROCESS.
P850010|S021|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2006|11/08/2006|||OK30|CHANGE IN MANUFACTURING EQUIPMENT USED IN THE COLLAGEN PURIFICATION PROCESS.
P840062|S011|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2006|11/08/2006|||OK30|CHANGE IN MANUFACTURING EQUIPMENT USED IN THE COLLAGEN PURIFICATION PROCESS.
P900033|S014|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2006|11/08/2006|||OK30|CHANGE IN MANUFACTURING EQUIPMENT USED IN THE COLLAGEN PURIFICATION PROCESS.
P960028|S016|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|CEEON INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2006|10/18/2006|||OK30|CHANGE TO CLEAN ROOM SPECIFICATIONS TO IMPROVE EFFICIENCY, ENVIRONMENTAL SPECIFICATIONS AND MODIFICATIONS, AND CONTINUOUS PRODUCT FLOW.
P990080|S009|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|ARRAY MULTIFOCAL INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2006|10/18/2006|||OK30|CHANGE TO CLEAN ROOM SPECIFICATIONS TO IMPROVE EFFICIENCY, ENVIRONMENTAL SPECIFICATIONS AND MODIFICATIONS, AND CONTINUOUS PRODUCT FLOW.
P020036|S006|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2006|11/09/2006|||OK30|MODIFICATION OF THE ACCEPTANCE CRITERION FOR A PRODUCTION INSPECTION FOR THE S.M.A.R.T. CONTROL NITINOL STENT SYSTEM.
P880086|S134|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTREGITY/VICTORY FAMILY PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2006|10/27/2006|||APPR|APPROVAL FOR AN ALTERNATE FEEDTHROUGH SUBSTRATE ON THE VICTORY FAMILY OF PACEMAKERS AND ICD?S.
P040048|S001|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2006|12/28/2006|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZIMMER, INC., WARSAW, INDIANA FOR DESIGN CONTROL, FINAL PACKAGING AND  LABELING OF THE CERAMIC ACETABULAR SHELL COMPONENTS AND APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US LLC, WESTERVILLE, OHIO.
P990080|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES, CEEON MODELS 911A & 913A, TECNIS MODELS Z9000|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2006|11/08/2006|||OK30|CHANGE IN HE POUCH IN WHICH THE IOL LENS TRAY IS PACKAGED; AND A CHANGE IN THE SYNTHESIS PROCESS OF THE POLYMERS.
P910023|S122|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2006|10/27/2006|||APPR|APPROVAL FOR AN ALTERNATE FEEDTHROUGH SUBSTRATE ON THE VICTORY FAMILY OF PACEMAKERS AND ICD?S.
P030054|S041|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2006|10/27/2006|||APPR|APPROVAL FOR AN ALTERNATE FEEDTHROUGH SUBSTRATE ON THE VICTORY FAMILY OF PACEMAKERS AND ICD?S.
P880086|S135|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2006|11/09/2006|||OK30|MODIFICATION TO THE MANUFACTURING SOFTWARE USED TO INITIALIZE THE VICTORY FAMILY OF PACEMAKERS.
P040027|S003|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS|MIR|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2006|10/25/2006|||APPR|APPROVAL FOR CHANGES MADE TO THE INSTRUCTION FOR USE.
P030035|S025|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2006|10/27/2006|||APPR|APPROVAL FOR AN ALTERNATE FEEDTHROUGH SUBSTRATE ON THE VICTORY FAMILY OF PACEMAKERS AND ICD?S.
P990080|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON MODELS 911A & 913A, TECNIS Z9000|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2006|11/08/2006|||OK30|CHANGE IN HE POUCH IN WHICH THE IOL LENS TRAY IS PACKAGED; AND A CHANGE IN THE SYNTHESIS PROCESS OF THE POLYMERS.
P990080|S012|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTRAVIOLET LIGHT ABSORING POSTERIOR CHAMBER INTRACOCULAR LENSES (IOLS) CEEON MODELS 911A AND 913A AND TECNIS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2006|11/06/2006|||OK30|
P000009|S021|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|SELECTED MODELS OF DUAL CHAMBER ICD DEVICES|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2006|01/30/2007|||APPR|APPROVAL FOR MINOR CHANGES TO THE RF CIRCUITRY IN THE LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND APPROVAL FOR UPDATED SOFTWARE VERSIONS TO CORRECT BRADYCARDIA AND TACHYCARDIA SOFTWARE ANOMALIES.
P950037|S047|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SELECTED MODELS OF IPG BRADY CARDIA DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2006|01/30/2007|||APPR|APPROVAL FOR MINOR CHANGES TO THE RF CIRCUITRY IN THE LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND APPROVAL FOR UPDATED SOFTWARE VERSIONS TO CORRECT BRADYCARDIA AND TACHYCARDIA SOFTWARE ANOMALIES.
P980023|S026|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|SELECTED MODELS OF SINGLE CHAMBER ICD DEVICES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2006|01/30/2007|||APPR|APPROVAL FOR MINOR CHANGES TO THE RF CIRCUITRY IN THE LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND APPROVAL FOR UPDATED SOFTWARE VERSIONS TO CORRECT BRADYCARDIA AND TACHYCARDIA SOFTWARE ANOMALIES.
P890003|S110|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS AND MEDTRONIC CARELINK MONITOR (MODEL 2490H)|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/13/2006|11/15/2006|||APPR|APPROVAL FOR THE MODEL 2490H MEDTRONIC CARELINK MONITOR AND MODEL 241 DDMA SOFTWARE.
P980035|S063|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA, ENPULSE, ADAPTA, SENSIA AND VERSA PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/13/2006|11/15/2006|||APPR|APPROVAL FOR THE MODEL 2490H MEDTRONIC CARELINK MONITOR AND MODEL 241 DDMA SOFTWARE.
P000054|S008|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2006|03/23/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERTS AND PATIENT INFORMATION BROCHURES TO ADDRESS THE RESULTS OF THE REPRODUCTIVE TOXICITY STUDY SUBMITTED IN PMA REPORTS P000058/R23 AND P000054/R6.
P000058|S019|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPPERED FUSION DEVICE|NEK|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2006|03/23/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERTS AND PATIENT INFORMATION BROCHURES TO ADDRESS THE RESULTS OF THE REPRODUCTIVE TOXICITY STUDY SUBMITTED IN PMA REPORTS P000058/R23 AND P000054/R6.
P980049|S024|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/2006|01/09/2008|||APPR|APPROVAL FOR THE ISOLINE 2CT DEFIBRILLATION LEADS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOLINE 2CT5 & 2CT6 TRANSVENOUS DEFIBRILLATION LEADS AND IS INDICATED TO PROVIDE RIGHT VENTRICULAR PACING, SENSING AND DEFIBRILLATION WHEN USED AS PART OF AN ELA MEDICAL IMPLANTABLE DEFIBRILLATOR.
P950022|S031|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2006|11/15/2006|||OK30|ALTERNATE SUPPLIER OF THE DR-1 BOOT COMPONENT.
P950020|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON MONORAIL|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/05/2006|||OK30|LOWERING OF THE RANGE OF AIR PRESSURE SUPPLIED TO AN EFD DISPENSER.
P980035|S064|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/SENSIA, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM, AT500|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/15/2006|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P990001|S027|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/15/2006|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P980016|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/15/2006|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P980050|S025|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF, GEM II AT FAMILY OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/15/2006|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P970012|S025|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/15/2006|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P900061|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM FAMILY OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/15/2006|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P010031|S054|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC II PROTECT, INSYNC III PROTECT, INTRINSIC 30, INTRINSIC, INSYNC SENTRY, INSYNC MAXIMO, CONCERTO|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/15/2006|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P010015|S025|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC/INSYNC III CRT-IPGS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|11/15/2006|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P960058|S055|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2006|02/26/2007|||APPR|APPROVAL FOR A MODIFICATION TO THE FIXTURE (T7181) USED IN THE HELIUM LEAK TESTING OF THE HIRES90K IMPLANT.
P050006|S002|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|10/16/2006|12/13/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P910023|S123|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2006|11/16/2006|||OK30|USE OF AN AUTOMATED SOLDERING PROCESS TO JOIN THE HV CAPACITOR WIRES TO THE HIGH VOLTAGE PRINTED CIRCUIT BOARD ASSEMBLY CONNECTOR PADS, AS AN ALTERNATE TO THE EXISTING MANUAL SOLDERING PROCESS.
P030054|S042|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2006|11/16/2006|||OK30|USE OF AN AUTOMATED SOLDERING PROCESS TO JOIN THE HV CAPACITOR WIRES TO THE HIGH VOLTAGE PRINTED CIRCUIT BOARD ASSEMBLY CONNECTOR PADS, AS AN ALTERNATE TO THE EXISTING MANUAL SOLDERING PROCESS.
P040013|S008|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2006|11/17/2006|||OK30|ADD AAI PHARMA-WILMINGTON FACILITY AS A QUALIFIED FACILITY TO CONDUCT A BIOASSAY ON THE DRUG COMPONENT OF THE DEVICE.
P960043|S060|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEMS|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2006|11/21/2006|||APPR|APPROVAL FOR REVISED INSTRUCTIONS FOR USE.
P030054|S043|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2006|11/30/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.
P030035|S026|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2006|11/30/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.
P830045|S104|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON/PHOENIX FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2006|11/30/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.
P880006|S047|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2006|11/30/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.
P880086|S136|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2006|11/30/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.
P910023|S124|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2006|11/30/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.
P970013|S014|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2006|11/30/2006|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.
P040036|S001|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|10/19/2006|12/04/2006|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P810002|S060|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2006|11/21/2007|||APPR|APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE POLYESTER YARN THAT IS USED IN THE FABRICATION OF: 1) THE KNITTED POLYESTER TUBULAR FABRIC THAT IS THE SOURCE MATERIAL FROM THE ST. JUDE MEDICAL MECHANICAL HEART VALVE SEWING CUFFS, AND 2) THE HEMASHIELD BOVINE COLLAGEN SEALED WOVEN POLYESTER VASCULAR GRAFT.
P030035|S027|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2006|11/21/2006|||OK30|ELIMINATION OF THE EXTRA PERIMETER STAKING EPOXY AT FINAL ASSEMBLY ON THE LV HYBRID AND COVER SUPPORT INTERFACE ON ALL AFFINITY, INTEGRITY, IDENTITY, VICTORY AND FRONTIER FAMILY OF DEVICES.
P880086|S137|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2006|11/21/2006|||OK30|ELIMINATION OF THE EXTRA PERIMETER STAKING EPOXY AT FINAL ASSEMBLY ON THE LV HYBRID AND COVER SUPPORT INTERFACE ON ALL AFFINITY, INTEGRITY, IDENTITY, VICTORY AND FRONTIER FAMILY OF DEVICES.
P050007|S004|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2006|03/23/2007|||APPR|APPROVAL FOR DESIGN CHANGES T THE STARCLOSE VASCULAR CLOSURE SYSTEM (VCS).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARCLOSE SE VASCULAR CLOSURE SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH AND FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.
P930016|S026|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2006|11/03/2006|||APPR|APPROVAL FOR AN UPGRADE OF THE WAVESCAN SOFTWARE TO VERSION 3.67 TO CORRECT A DESIGN FLAW THAT LED TO AN INCORRECT PATIENT TREATMENT BEING DELIVERED, AND TO INTRODUCE AN ADDITIONAL SOFTWARE CHECK TO MITIGATE TREATMENT CALCULATION ERRORS.
P910023|S125|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2006|11/21/2006|||OK30|MODIFICATIONS TO THE ICD MANUFACTURING SOFTWARE.
P030054|S044|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2006|11/21/2006|||OK30|MODIFICATIONS TO THE ICD MANUFACTURING SOFTWARE.
P880047|S011|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2006|11/21/2006|||OK30|CHANGE IN THE PACKAGING MATERIAL.
P900023|S046|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|AB5000/BVS 5000  CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/26/2006|04/24/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE AB5000 VENTRICLE CANNULA RESTRAINT SYSTEM, EXTENDED SHELF LIFE (2 YEARS) FOR THE AB5000 VENTRICLE, AND RECLASSIFICATION OF A PRECAUTION TO A WARNING FOR THE BVS 5000.
P000058|S020|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/27/2006|12/21/2007|||APPR|APPROVAL FOR CHANGES TO THE PACKAGE INSERT AND KIT BOX TEXT BASED ON REPORTS ASSOCIATED WITH SEVERAL TYPES OF AES.  THESE AES WERE THE PRESENCE OF FLUID-FILLED CYSTS OR RADIOGRAPHIC EVIDENCE OF PERI-IMPLANT TRANSIENT BONE RESORPTION.  IT?S BELIEVED THAT OVERPACKING OF THE ACS COMPONENT WITHIN A CONFINED SPACE AND/OR HYPERCONCENTRATING THE RHBMP-2 SOLUTION WERE RESPONSIBLE FOR THE AES.
P000054|S009|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/27/2006|12/21/2007|||APPR|APPROVAL FOR CHANGES TO THE PACKAGE INSERT AND KIT BOX TEXT BASED ON REPORTS ASSOCIATED WITH SEVERAL TYPES OF AES.  THESE AES WERE THE PRESENCE OF FLUID-FILLED CYSTS OR RADIOGRAPHIC EVIDENCE OF PERI-IMPLANT TRANSIENT BONE RESORPTION.  IT?S BELIEVED THAT OVERPACKING OF THE ACS COMPONENT WITHIN A CONFINED SPACE AND/OR HYPERCONCENTRATING THE RHBMP-2 SOLUTION WERE RESPONSIBLE FOR THE AES.
P860057|S041|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA BIOPROSTHESES MODELS 3000 AND 3000TFX|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/27/2006|02/13/2007|||APPR|APPROVAL FOR A MANUFACTURING PROCESS ENHANCEMENT FOR THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODELS 3000 AND 3000TFX POLYESTER BAND/ELGILOY BAND SUB-ASSEMBLY JOINING TECHNIQUE CONSISTING OF SEWING THROUGH ALL OF THE BAND HOLES.
P000040|S009|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION  SYSTEM|MNB|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2006|03/23/2007|||APPR|APPROVAL TO INCLUDE CLEANING, STERILIZATION AND REUSE INSTRUCTIONS FOR THE HTA SYSTEM SCOPE ADAPTORS IN A NEW PACKAGE INSERT AND IN THE HTA SYSTEM USER?S MANUAL.
P030009|S007|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2006|11/21/2006|||OK30|REDUCTION IN THE NUMBER OF TEST SAMPLES FOR VARIOUS QUALITY CONTROL TESTS FOR THE DRIVER MX2 CORONARY STENT SYSTEM.
P890003|S111|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|2490G/H/J CARELINK MONITOR, 2020A CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2006|03/02/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GOVE, ILLINOIS.
P890003|S112|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC 2490 A/C/D/E/G/H/J CARELINK MONITORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2006|11/29/2006|||APPR|APPROVAL FOR THE MCI UPGRADE TO INCLUDE THE BRADY ENHANCEMENTS.
P980035|S065|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA & ENPULSE FAMILIES OF PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2006|03/02/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GOVE, ILLINOIS.
P900061|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM FAMILY OF ICDS|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2006|03/02/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GOVE, ILLINOIS.
P010031|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS INSYNC FAMILIES OF CRT-ICDS|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2006|03/02/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GOVE, ILLINOIS.
P980016|S088|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SELECTED FAMILIES OF ICDS|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2006|03/02/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRONIC ASSEMBLY, BUFFALO GOVE, ILLINOIS.
P900061|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2006|11/29/2006|||APPR|APPROVAL FOR THE MCI UPGRADE TO INCLUDE THE BRADY ENHANCEMENTS.
P980035|S066|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2006|11/29/2006|||APPR|APPROVAL FOR THE MCI UPGRADE TO INCLUDE THE BRADY ENHANCEMENTS.
P010031|S056|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF CRT-ICD'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2006|11/29/2006|||APPR|APPROVAL FOR THE MCI UPGRADE TO INCLUDE THE BRADY ENHANCEMENTS.
P930038|S048|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2006|03/15/2007|||APPR|APPROVAL FOR USE OF AN ALTERNATE COLLAGEN CRUSHER.
P020026|S028|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2006|11/29/2006|||OK30|CHANGE IN THE ENVIRONMENTAL CONDITIONS OF THE MANUFACTURING FACILITY.
P980016|S089|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SELECTED FAMILIES OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2006|11/29/2006|||APPR|APPROVAL FOR THE MCI UPGRADE TO INCLUDE THE BRADY ENHANCEMENTS.
P020026|S029|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2006|06/29/2007|||APPR|APPROVAL FOR THE INTRODUCTION OF NITROGEN MASS FLOW CONTROLLERS.
P040020|S003|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC IOL MODELS SN6AD3 AND MN6AD3|MFK|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2006|01/30/2007|||APPR|APPROVAL FOR THE ADDITION OF A PROLATE SURFACE TO THE ANTERIOR OPTIC, CHANGING THE OPTIC SHAPE FACTOR TO BE MORE EQUICONVEX, AND THE USE OF NATURAL MATERIAL.
P020026|S030|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENTS ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/2006|01/10/2007|||APPR|APPROVAL FOR A PROCESS ENHANCER FOR AN ADHESIVE USED IN CONSTRUCTION OF THE DELIVERY SYSTEM.
P020026|S031|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/2006|12/07/2006|||APPR|APPROVAL FOR AN UPDATED ANALYTICAL TEST METHOD FOR WATER CONTENT DETERMINATION.
P020026|S032|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2006|12/07/2006|||APPR|APPROVAL FOR AN UPDATED ANALYTICAL TEST METHOD FOR SOLVENT RESIDUE AFTER EVAPORATION.
P880086|S138|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VICTORY PULSE GENERATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2006|11/29/2006|||OK30|ADDITIONAL HYBRID SCREENING TEST.
P810002|S061|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/2006|12/20/2006|||APPR|APPROVAL FOR CHANGES TO THE EDUCATIONAL BOOKLET FOR ALL PATIENTS RECEIVING A ST. JUDE MEDICAL MECHANICAL HEART VALVE.
P810031|S032|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES ? HEALON, HEALON GV, AND HEALON5|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2006|12/01/2006|||OK30|CHANGE TO RELEASE FINAL PRODUCT BY PARAMETRIC RELEASE.
P030005|S039|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2006|02/08/2007|||APPR|APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.
P960011|S012|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BD 1% OVD|LZP|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2006|12/19/2006|||APPR|APPROVAL TO CHANGE THE TRADE NAME FROM BIOLON TO BD1% OVD.
P010012|S142|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/CD2/RENEWAL /RENEWAL 3|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2006|02/08/2007|||APPR|APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.
P960040|S135|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV /PRIZM/ VITALITY|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2006|02/08/2007|||APPR|APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.
P910077|S066|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX/ MINI/ CONTAK CD & CD2|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2006|02/08/2007|||APPR|APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.
P940031|S059|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR/ DISCOVERY/ MERIDIAN/ PULSAR|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2006|02/08/2007|||APPR|APPROVAL FOR THE GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE.
P980037|S021|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/07/2006|03/06/2007|||APPR|APPROVAL FOR MANUFACTURING CHANGES TO THE ANGIOJET PUMP SET PISTON, SENSOR CUP AND BOOT.
P950022|S032|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA LEAD MODELS 1580, 1581 AND 1582; RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2006|12/14/2006|||APPR|APPROVAL FOR A HELIX ATTACHMENT MODIFICATION FOR THE RIATA 1580, 1581 AND 1582 LEADS AS WELL AS A CRIMP-WELD COUPLING MODIFICATION FOR THE RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES.
P030017|S016|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/2006|02/01/2007|||APPR|APPROVAL FOR CHANGING THE MATERIAL OF CONSTRUCTION FOR THE PASSING ELEVATOR, A SURGICAL TOOL USED WITH THE ARTISAN 2.8 SURGICAL LEAD, FROM CYCOLOY TO PEBAX.
P030017|S017|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2006|02/15/2007|||APPR|APPROVAL FOR PRECISION OMG (OBSERVATIONAL MECHANICAL GATEWAY) CONNECTOR-A.
P910077|S067|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/06/2006|||OK30|ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.
P020018|S019|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOCASCULAR GRAFT WITH H + L-B ONE-SHOT INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/06/2006|||OK30|USE OF A CONTRACT MANUFACTURER FOR THE MAIN BODY GRAFT SUBASSEMBLY.
P940031|S060|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MERIDIAN/DISCOVERY FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/06/2006|||OK30|ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.
P960040|S136|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/06/2006|||OK30|ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.
P010012|S143|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/06/2006|||OK30|ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.
P030005|S040|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR FAMILY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/06/2006|||OK30|ADDITIONAL INCOMING ACCEPTANCE TEST SPECIFICATION.
P020004|S016|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/06/2006|||OK30|CHANGE FROM A MANUAL TO A MACHINE TRIM PROCESS.
P020018|S020|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/06/2006|||OK30|USE OF AN OUTSIDE SUPPLIER FOR MACHINING OF THE THREADED TOP CAP.
P020018|S021|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|11/29/2006|||OK30|CHANGE TO THE SILICONE LUBRICANT USED DURING MANUFACTURE OF THE DEVICE.
P810046|S220|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|CORONARY DILATATION CATHETERS|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/11/2006|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS, SANTA TERESA, NEW MEXICO.
P890043|S039|ABBOTT VASCULAR|26531 YNEZ ROAD BUILDING G|MAILING P.O. 9018|TEMECULA|CA|92590||CATHETER, CORONARY, ATHERECTOMY|FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/11/2006|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS, SANTA TERESA, NEW MEXICO.
P010020|S003|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/05/2006|||OK30|ADD A SECOND IN-PROCESS CYTOTOXICITY TESTING SITE.
P920023|S019|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME URETHRAL STENT|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/05/2006|||OK30|ADD A SECOND IN-PROCESS CYTOTOXICITY TESTING SITE.
P000053|S006|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2006|12/05/2006|||OK30|ADD A SECOND IN-PROCESS CYTOTOXICITY TESTING SITE.
P950020|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2006|12/06/2006|||OK30|USE OF A CARBOLITE OVEN IN THE LETTERKENNY, IRELAND FACILITY TO CURE THE MDX COATING ON BALLOON FOLDERS.
P020024|S014|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2006|01/30/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE DEVICE PACKAGING AND INCLUSION OF A THREE YEAR SHELF LIFE FOR THE ORIGINAL AMPLATZER DUCT OCCLUDER AND SEPTAL OCCLUDER DELIVERY AND EXCHANGE SYSTEMS.
P000039|S020|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2006|01/30/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE DEVICE PACKAGING AND INCLUSION OF A THREE YEAR SHELF LIFE FOR THE ORIGINAL AMPLATZER DUCT OCCLUDER AND SEPTAL OCCLUDER DELIVERY AND EXCHANGE SYSTEMS.
P020024|S015|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM|MAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|11/03/2006|05/03/2007|||APPR|APPROVAL OF THE REVISED POST-APPROVAL STUDY.
P010031|S057|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CONCERTO MODEL C154DWK ICD|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/2006|04/17/2007|||APPR|APPROVAL FOR THE MEDTRONIC CONCERTO MODELS C154DWK AND C164AWK ICD SYSTEMS AND CONCERTO-VIRTUOSO V1.2 SOFTWARE APPLICATION MODEL SW002.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC CONCERTO MODELS C154DWK AND C164AWK ICD SYSTEMS AND IS INDICATED AS FOLLOW:  THE CONCERTO IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION # 35% AND A PROLONGED QRS DURATION.  ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION.
P860004|S088|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|11/08/2006|05/01/2007|||APPR|APPROVAL FOR: 1) A NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 2) A MODIFIED MANUFACTURING MONITORING PROCESS TO ASSURE CONFORMANCE TO NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 3) A CHANGE TO THE CATHETER TIP MATERIAL FOR CATHETER MODEL 8731SC AND REVISION KIT MODEL 8598A; AND 4) LABELING REVISIONS.
P040038|S007|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|11/13/2006|02/05/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P990052|S014|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)|MPV|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2006|12/14/2006|||OK30|ESTABLISH CENDRES & METAUX SA AS A SECOND SOURCE SUPPLIER FOR THE TITANIUM HOUSING OF THE FLOATING MASS TRANSDUCER (FMT ? A FUNCTIONAL COMPONENT OF VIBRATING OSSICULAR PROSTHESIS (VORP)).
P800022|S055|Allergan|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93117|5506|Implant, dermal, for aesthetic use|COSMODERM/ COSMOPLAST COLLAGEN IMPLANT, COSMODERM COSMOPLAST HUMAN-BASED COLLAGEN IMPLANT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/2006|12/19/2006|||APPR|APPROVAL FOR A CHANGE IN THE GLUTARALDEHYDE CROSSLINKER CONCENTRATION.
P020018|S022|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L ONE SHOT INTRODUCTION SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2006|09/25/2007|||APPR|APPROVAL FOR A CHANGE TO THE 304V STAINLESS STEEL WIRE SUPPLIER?S PROCESS TO INCLUDE 100% EDDY CURRENT TESTING.
P810046|S221|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER RX CORONARY DILATATION CATHETER|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2006|12/11/2006|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD, OFFALY, IRELAND.
P900023|S047|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|IPULSE CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/2006|12/11/2007|||APPR|APPROVAL FOR THE IPULSE CIRCULATORY SUPPORT SYSTEM, A UNIT THAT WILL SUPPORT PATIENTS IN NEED OF FULL CIRCULATORY SUPPORT USING THE BVS 5000 BLOOD PUMP OR THE AB5000 VENTRICLE, OR PARTIAL VENTRICULAR ASSIST USING THE APPROVED INTRA-AORTIC BALLOON PUMP (IABP).  THE DEVICE CONSOLE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IPULSE CIRCULATORY SUPPORT SYSTEM AND IS INDICATED FOR USE IN CONJUNCTION WITH THE ABIOMED AB 5000 VENTRICLE AND THE BVS 5000 BLOOD PUMP.
P040012|S024|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK & ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2006|12/14/2006|||OK30|ADDITION OF AN INSPECTION STEP.
P950022|S033|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|THE RIATA ST FAMILY OF LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2006|02/15/2007|||APPR|APPROVAL TO ADD AN AUTOMATED TRIMMING FIXTURE TO TRIM EXCESS SILICONE ADHESIVE ON THE SHOCK ELECTRODES DURING PRODUCTION OF THE RIATA ST FAMILY OF LEADS.
P910054|S004|Toray Industries (America), Inc.|461 FIFTH AVENUE, 9TH FLOOR||NEW YORK|NY|10017||CATHETER, PERCUTANEOUS (VALVULOPLASTY)|TORAY INOUE BALLON CATHETER|MAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2006|07/03/2007|||APPR|APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE GUIDEWIRE AND STYLET BULK MATERIAL.
P010014|S011|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2006|12/15/2006|||OK30|CHANGE IN THE MINIMUM AND MAXIMUM PARAMETERS FOR THE DWELL TIME DURING THE HEAT SEALING F BLISTER PACKS.
P040006|S003|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|CHARITE ARTIFICIAL DISC|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2006|12/15/2006|||OK30|ADDITION TO THE DEPUY (IRELAND) LTD. FACILITY OF AN OPTIMAL IN-PROCESS CLEANLINE AND THREE NEW PIECES OF EQUIPMENT: A MAZAK INTEGREX MACHINING CENTRE, A SCHLICK BLAST UNIT AND A TRUMPF LASER-MARKING MACHINE.
P010014|S012|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2006|04/23/2008|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS FOR A MOLD RELEASE AGENT.
P910001|S026|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2006|05/11/2007|||APPR|APPROVAL FOR THE REMOVAL OF A COATING ON THE INNER LUMEN OF THE EXTREME CATHETER MODEL NUMBERS 114-001, 117-002, AND 120-001, THE CHANGE TO BLACK TUBING FOR 0.9 MM CATHETER MODEL NUMBERS 110-003 AND 110-004 X-80, AND THE CHANGE IN THE STRAIN RELIEF MATERIAL DUROMETER FOR THE 0.9 MM EXTREME CATHETER MODEL NUMBERS 110-001, 110-002, 110-152 AND 0.7 MM EXTREME CATHETER MODEL 110-005 TO PREVENT KINKING AT THE STRAIN RELIEF.
P950020|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2006|12/14/2006|||OK30|USE OF A NEW BLADE PLACEMENT MACHINE.
P010019|S005|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|O2 OPTIX (LOTRAFILCON B) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2006|12/19/2006|||OK30|IMPLEMENT A NEW ADVANCED TOOL SYSTEM (ATS) TO INCREASE PRODUCTION FOR THE LOTRAFILCON B CONTACT LENSES.
P040033|S002|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2006|02/23/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SMITH & NEPHEW ORTHOPAEDIC LTD. IN WARWICKSHIRE, UNITED KINGDOM, FOR PURCHASING, RECEIVING ACCEPTANCE ACTIVITIES, STORAGE AND RELEASE AND DISPATCH OF PRODUCT.
P850051|S064|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|LEGACY SR IPG|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2006|12/11/2006|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P890003|S113|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|LEGACY DR, WRENCH ACCESSORY KIT|NVZ|CV|30-Day Notice||N|11/20/2006|12/11/2006|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P900061|S070|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACTIVE CAN EMULATOR CONNECTOR, TRANSVERSE  EPICARDIAL DEFIBRILLATION LEAD, LEAD SLEEVE ADAPTER KIT|LWS|CV|30-Day Notice||N|11/20/2006|12/11/2006|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P920015|S036|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PIN PLUG, DF-1 Y-ADAPTER/ EXTENDER, LEAD ASSEMBLY SILICONE DEFIBRILLATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2006|12/11/2006|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
P960013|S024|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL 1688T/TC LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2006|12/11/2006|||OK30|REVISION TO THE WELD PROCESS OF THE INNER COIL TO THE SHAFT COUPLING/SPRING ASSEMBLY.
P030006|S012|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2006|12/22/2006|||APPR|APPROVAL FOR REMOVAL OF A CAPACITOR FROM THE COMPUTER BOARD INPUT LINES TO ENABLE THE TACHOMETER READOUT TO DISPLAY PUMP SPEED AND MODIFICATION OF THE CAPACITORS FROM THE COMPUTER INPUT/OUTPUT BOARD TO DISPLAY OF TEMPERATURE DATA.
P910023|S126|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2006|12/13/2006|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE ICD/CRT-D DEVICE HYBRID: 1) ADDITION OF A NEW C64 MICRO CONTROLLER INTEGRATED CIRCUIT (IC); 2) CHANGES TO THE C46 VSS SUPPLY CAPACITOR FROM 3.3 UF TO 33 UF; AND 3) CHANGES TO DIODES D17, D19 AND D23 IN THE PROTECTION CIRCUIT.
P030054|S045|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2006|12/13/2006|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE ICD/CRT-D DEVICE HYBRID: 1) ADDITION OF A NEW C64 MICRO CONTROLLER INTEGRATED CIRCUIT (IC); 2) CHANGES TO THE C46 VSS SUPPLY CAPACITOR FROM 3.3 UF TO 33 UF; AND 3) CHANGES TO DIODES D17, D19 AND D23 IN THE PROTECTION CIRCUIT.
P860003|S045|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/22/2006|12/22/2006|||APPR|APPROVAL FOR A MATERIAL CHANGE FOR THE SPIKE PORTION OF THE DRIP CHAMBER OF THE UVAR XTS PROCEDURAL KIT, WHICH IS USED WITH THE UVAR XTS PHOTOPHERESIS SYSTEM.
P010055|S003|PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTALUND OPERATIONS AB CORETHERM SYSTEM MICROWAVE THERMOTHERAPY|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2006|12/21/2006|||OK30|CHANGE IN THE MATERIAL USED IN THE TIP OF THE CATHETER COMPONENT OF THE DEVICE.
P830063|S005|BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|PRISMA TPE 2000 SET|MDP|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/2006|06/19/2009|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PRISMA TPE 2000 SET: 1) DIRECT CONNECTION OF THE PLASMAFILTER TO THE CARTRIDGE PLATE VIA THE DIALYSATE CONNECTORS; 2) OPTIMIZATION AND SIMPLIFICATION OF THE TUBING CIRCUIT; 3) THE PLASMAFILTER ORIENTED PARALLEL TO THE CARTRIDGE PLATE; 4) THE LINES FIXED BY PAWL AND RATCHET MECHANISM; 5) THE PUMP SEGMENT FIXED BY CLICKING VIA A SPECIFIC JOINT CONNECTOR; AND 6) BLOOD LINES SCREWED BY CONNECTORS TO THE BLOOD PORT FILTER.
P980022|S018|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK(MODELS MMT-7703 TRANSMITTER, MMT-7705 CHARGER, MMT-7706 TEST PLUG)|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2006|02/06/2007|||APPR|APPROVAL FOR THE MINILINK TRANSMITTER (MMT-7703), MINILINK CHARGER (MMT-7705), AND MINILINK TEST PLUG (MMT-7706).
P010025|S009|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2006|01/17/2007|||APPR|APPROVAL FOR MOUNTING HOLOGIC SECURVIEW REFERENCE IMAGE VIEWER INTO THE SELENIA ACQUISITION WORKSTATION (AWS) CABINET FOR RETRIEVING AND DISPLAYING PATIENT?S PRIOR IMAGES BUT NOT FOR PRIMARY IMAGE DIAGNOSIS.
P990052|S015|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE|MPV|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/2006|12/13/2006|||APPR|APPROVAL FOR A CHANGE IN THE WORDING OF THE INDICATIONS FOR USE STATEMENT AND A NEW PRODUCT CODE DESCRIPTION THAT REMOVES THE REFERENCE TO HEARING AIDS.  THE DEVICE IS INDICATED FOR USE IN ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS.  PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
P030009|S008|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/27/2006|12/08/2006|||APPR|APPROVAL FOR THE ADDITION OF A WARNING, WHICH WILL INFORM THE PHYSICIAN OF THE POTENTIAL VESSEL WALL DAMAGE THAT COULD OCCUR IF FLUOROSCOPY IS NOT USED DURING WIRE INTERCHANGE, AND AN UPDATE OF THE GUIDE WIRE INTERCHANGE INSTRUCTIONS TO ENSURE THAT PHYSICIANS USE HIGH QUALITY FLUOROSCOPY TO DETERMINE GUIDE WIRE POSITION BEFORE ADVANCING INTO THE CORONARY ARTERIES.
P980035|S067|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2006|12/21/2006|||OK30|CHANGES IN THE MANUFACTURING FLOW FOR THE FINAL DEVICE ASSEMBLY FOR IMPLANTABLE PULSE GENERATORS.
P970012|S026|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 MEDTRONIC IMPLANTABLE PULSE GENERATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2006|12/21/2006|||OK30|CHANGES IN THE MANUFACTURING FLOW FOR THE FINAL DEVICE ASSEMBLY FOR IMPLANTABLE PULSE GENERATORS.
P960040|S137|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2006|12/21/2006|||OK30|CHANGE IN THE OVEN CURING CYCLE FOR HYBRID ASSEMBLIES FOR THE CONTAK RENEWAL AND VITALITY FAMILY OF ICDS.
P010012|S144|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2006|12/21/2006|||OK30|CHANGE IN THE OVEN CURING CYCLE FOR HYBRID ASSEMBLIES FOR THE CONTAK RENEWAL AND VITALITY FAMILY OF ICDS.
P810006|S025|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2006|12/19/2006|||OK30|CHANGE IN MANUFACTURING EQUIPMENT USED IN THE COLLAGEN PURIFICATION PROCESS.
P850010|S022|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2006|12/19/2006|||OK30|CHANGE IN MANUFACTURING EQUIPMENT USED IN THE COLLAGEN PURIFICATION PROCESS.
P010031|S058|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO MODEL C154DWK IMPLANTABLE DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2006|02/15/2007|||APPR|APPROVAL FOR FIRMWARE UPDATES TO 1) ADDRESS A ?SOFT? RATE LIMIT POWER ON RESET, 2) LOAD A TEMPERATURE SENSITIVITY UPDATE AT THE TIME OF MANUFACTURING, AND 3) LOAD OPTIVOL ENHANCEMENTS (FOR USE OUTSIDE OF THE UNITED STATES ONLY) AT THE TIME OF MANUFACTURING.
P980016|S090|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO MODELS D154AWG/D154VWC|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2006|02/15/2007|||APPR|APPROVAL FOR FIRMWARE UPDATES TO 1) ADDRESS A ?SOFT? RATE LIMIT POWER ON RESET, 2) LOAD A TEMPERATURE SENSITIVITY UPDATE AT THE TIME OF MANUFACTURING, AND 3) LOAD OPTIVOL ENHANCEMENTS (FOR USE OUTSIDE OF THE UNITED STATES ONLY) AT THE TIME OF MANUFACTURING.
P020045|S021|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR,FREEZOR XTRA & FREEZOR MAX CRYOABLATION DEVICES|LPB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2007|04/18/2007|||APPR|APPROVAL FOR CHANGES TO THE LEAK DETECTION SYSTEM IN THE FREEZOR CATHETER AND FREEZOR XTRA DEVICES FROM A SINGLE BARE STAINLESS STEEL WIRE TO A DUPLEX INSULATED WIRE MADE OF TWO ELECTRODES.
P980035|S068|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2006|12/14/2006|||APPR|APPROVAL FOR DESIGN CHANGES TO THE MO16 SRAM PACKAGING FOR THE DEVICE HYBRIDS AND A CHANGE IN THE BAROMETRIC PRESSURE REQUIREMENT FROM 6 ATA TO 4 ATA FOR THE ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P980016|S091|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2006|12/14/2006|||APPR|APPROVAL FOR DESIGN CHANGES TO THE MO16 SRAM PACKAGING FOR THE DEVICE HYBRIDS AND A CHANGE IN THE BAROMETRIC PRESSURE REQUIREMENT FROM 6 ATA TO 4 ATA FOR THE ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P000018|S043|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH SYSTEM|MOU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|11/28/2006|11/19/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960040|S138|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2006|06/06/2007|||APPR|APPROVAL FOR A REDUCTION IN THE PRE-SEAL CAPACITOR AGING PROCESSING TIME FOR STANDARD AND HIGH ENERGY CAPACITORS.
P020009|S034|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2006|06/22/2007|||APPR|APPROVAL TO IMPLEMENT AN ALTERNATIVE MANUFACTURING FIXTURE AND TO IMPLEMENT A FOUR PORT VACUUM DECAY TESTER (VDT).
P040016|S019|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2006|06/22/2007|||APPR|APPROVAL TO IMPLEMENT AN ALTERNATIVE MANUFACTURING FIXTURE AND TO IMPLEMENT A FOUR PORT VACUUM DECAY TESTER (VDT).
P860019|S216|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2006|06/22/2007|||APPR|APPROVAL TO IMPLEMENT AN ALTERNATIVE MANUFACTURING FIXTURE AND TO IMPLEMENT A FOUR PORT VACUUM DECAY TESTER (VDT).
P910023|S127|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST. JUDE MEDICAL HOUSECALL PLUS SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/2006|12/14/2006|||APPR|APPROVAL FOR THE ST. JUDE MEDICAL HOUSECALL PLUS SYSTEM WHICH WILL ALLOW INTERACTIVE VOICE RESPONSE (IVR).
P910023|S128|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/2006|12/14/2006|||APPR|APPROVAL FOR: 1) AN ALTERNATE ELECTROLYTE (TM422) IN THE HIGH VOLTAGE CAPACITOR USED IN THE ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR AND EPIC II/II + DR/VR/HF DEVICES; AND 2) THE MINOR MODIFICATIONS TO THE CRYSTAL TUNING FORK USED IN EPIC, EPIC+, EPIC II/II +, ATLAS, ATLAS+, ATLAS II/II + DEVICES.
P030054|S046|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM & EPIC HF|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/2006|12/14/2006|||APPR|APPROVAL FOR: 1) AN ALTERNATE ELECTROLYTE (TM422) IN THE HIGH VOLTAGE CAPACITOR USED IN THE ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR AND EPIC II/II + DR/VR/HF DEVICES; AND 2) THE MINOR MODIFICATIONS TO THE CRYSTAL TUNING FORK USED IN EPIC, EPIC+, EPIC II/II +, ATLAS, ATLAS+, ATLAS II/II + DEVICES.
P960013|S025|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|OPTISENSE MODEL 1699T/TC LEADS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/30/2006|05/07/2007|||APPR|APPROVAL FOR THE OPTISENSE MODEL 1699T AND 1699TC LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPTISENSE MODEL 1699T AND 1699TC LEADS AND ARE DESIGNED FOR PERMANENT SENSING AND PACING IN THE RIGHT ATRIUM, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. AN ACTIVE FIXATION LEAD SUCH AS THE MODEL 1699 MAY BE INDICATED FOR PATIENTS WHERE PERMANENT FIXATION OF PASSIVE LEADS IS SUSPECTED TO BE UNSTABLE. IN ATRIAL APPLICATIONS, THE USE OF A SCREW-IN LEAD MAY BE INDICATED IN THE PRESENCE OF AN ABNORMAL, SURGICALLY ALTERED OR EXCISED ATRIAL APPENDAGE.
P030031|S004|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/2006|04/23/2007|||APPR|APPROVAL FOR MERGING THE LABELING FOR THE TWO APPROVED INDICATIONS FOR THE NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS (ATRIAL FLUTTER UNDER P030031, AND VENTRICULAR TACHYCARDIA UNDER P040036) AND UPDATING THE LABELING FOR THE CELSIUS THERMOCOOL WHICH REMAINS APPROVED FOR TREATMENT OF ATRIAL FLUTTER ONLY.
P040036|S002|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/2006|04/23/2007|||APPR|APPROVAL FOR MERGING THE LABELING FOR THE TWO APPROVED INDICATIONS FOR THE NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS (ATRIAL FLUTTER UNDER P030031, AND VENTRICULAR TACHYCARDIA UNDER P040036) AND UPDATING THE LABELING FOR THE CELSIUS THERMOCOOL WHICH REMAINS APPROVED FOR TREATMENT OF ATRIAL FLUTTER ONLY.
P010012|S145|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2006|12/21/2006|||OK30|CHANGE FROM CABLE OPERATED ANCHOR POST SPOTWELD EQUIPMENT TO PNEUMATICALLY OPERATED ANCHOR POST SPOTWELD EQUIPMENT.
P960040|S139|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2006|12/21/2006|||OK30|CHANGE FROM CABLE OPERATED ANCHOR POST SPOTWELD EQUIPMENT TO PNEUMATICALLY OPERATED ANCHOR POST SPOTWELD EQUIPMENT.
P890003|S114|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS PACEMAKERS, CARELINK MONITORS, CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2006|09/14/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PENANG, MALAYSIA.
P900061|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CARELINK MONITOR MODELS 2490G, 2490H, 2490J, AND THE 2020A CARDIOSIGHT READER|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2006|09/14/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PENANG, MALAYSIA.
P980016|S092|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS, MAXIMO & ENTRUST ICDS|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2006|09/14/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PENANG, MALAYSIA.
P980035|S069|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA, ENPULSE & ADAPTA PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2006|09/14/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PENANG, MALAYSIA.
P010031|S059|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS, SENTRY, MAXIMO CRT-ICDS|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2006|09/14/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PENANG, MALAYSIA.
P990066|S026|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE DS AND  ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS|MUE|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/2006|01/03/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING REGARDING THE PLACEMENT OF THE LATERALITY AND VIEW MARKER THAT FDA APPROVED UNDER P990066/S022.
P030017|S018|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/2006|03/09/2007|||APPR|APPROVAL FOR ?MED-A? (OR ?MEDICAL ADHESIVE?) SILICONE ADHESIVE.
P790017|S086|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2006|08/17/2007|||APPR|APPROVAL TO: 1) INTRODUCE AN AUTOMATED INFLATION DEVICE, REPLACING THE CURRENT MANUAL PROCESS, TO INFLATE PTCA BALLOONS PRIOR TO IN-PROCESS FUNCTIONAL TESTING; AND 2) REDUCE THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.
P000021|S009|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2006|01/04/2007|||OK30|CHANGE TO REVISE THE CUVETTE FILM MANUFACTURING PROCESS.
P020027|S005|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CATRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2006|01/04/2007|||OK30|CHANGE TO REVISE THE CUVETTE FILM MANUFACTURING PROCESS.
P020004|S018|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2006|01/05/2007|||OK30|CHANGE IN THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE FOR THE DEVICE.
P050012|S005|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM STS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2006|12/26/2006|||OK30|AUTOMATION OF THE FINAL RELEASE TEST PROCEDURE FOR RELEASE OF THE STS RECEIVER.
P040016|S020|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2006|05/10/2007|||APPR|APPROVAL TO IMPLEMENT AN ALTERNATE LOCATION FOR PREPARATION OF A HYDROPHILIC COATING SOLUTION COMPONENT KNOWN AS PRE-BIOSLIDE AND APPROVAL FOR AN ALTERNAT SUPPLIER OF THE POLYMER INITIATOR AIBN.
P030025|S042|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2006|05/10/2007|||APPR|APPROVAL TO IMPLEMENT AN ALTERNATE LOCATION FOR PREPARATION OF A HYDROPHILIC COATING SOLUTION COMPONENT KNOWN AS PRE-BIOSLIDE AND APPROVAL FOR AN ALTERNAT SUPPLIER OF THE POLYMER INITIATOR AIBN.
P950020|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2006|05/10/2007|||APPR|APPROVAL TO IMPLEMENT AN ALTERNATE LOCATION FOR PREPARATION OF A HYDROPHILIC COATING SOLUTION COMPONENT KNOWN AS PRE-BIOSLIDE AND APPROVAL FOR AN ALTERNAT SUPPLIER OF THE POLYMER INITIATOR AIBN.
P860019|S217|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2006|05/10/2007|||APPR|APPROVAL TO IMPLEMENT AN ALTERNATE LOCATION FOR PREPARATION OF A HYDROPHILIC COATING SOLUTION COMPONENT KNOWN AS PRE-BIOSLIDE AND APPROVAL FOR AN ALTERNAT SUPPLIER OF THE POLYMER INITIATOR AIBN.
P900052|S014|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS|LNY|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2006|08/28/2007|||APPR|APPROVAL FOR A CHANGE TO THE IN-PROCESS MANUFACTURING PACKAGE INSPECTION PROCEDURE OF THE PORT-A-CATH EPIDURAL AND PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS.  THE MODIFICATIONS TO THE IN-PROCESS POUCH SEAL INSPECTION INCLUDES: 1) FIVE TEST INTERVALS WILL BE PERFORMED OVER A SINGLE DAY VERSUS THREE TEST INTERVALS PER EACH MANUFACTURING JOB.  2) THE CURRENT FIVE POUCHES TESTED USING THE PULL TEST WILL BE REDUCED TO TWO POUCHES PER TEST PERIOD AND THE CURRENT TWO POUCHES INSPECTED USING HAND PEEL AND VISUAL VERIFICATION WILL BE INCREASED TO FIVE POUCHES PER TEST PERIOD.  3) THE RESULTS OF THE GAGE PULL TEST AND VISUAL INSPECTION WILL BE RECORDED IN THE INDIVIDUAL JOB FOLDER PER ESTABLISHED TEST INTERVAL.  4) THE POUCH SEALING PROCESS PARAMETER SETTINGS WILL CONTINUE TO BE RECORDED FOR EACH JOB AND EACH INSPECTION INTERVAL.
P020047|S007|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION & MULTI-LINK MINI VISION CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/2006|02/09/2007|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE W-CREST PORTION OF BOTH MULTI-LINK VISION STENT SYSTEMS AS WELL AS A NON-LINEAR LINK SHIFT TO THE MEDIUM DESIGN MULTI-LINK VISION CORONARY STENT SYSTEM.
P810031|S033|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2006|08/30/2007|||APPR|APPROVAL FOR A DIFFERENT RELEASE AGENT TO BE USED WITH THEIR EXISTING PETG MATERIAL IN THE OUTER BLISTER TRAY FOR THE SECONDARY PACKAGING OF ALL OF THE HEALON OPHTHALMIC VISCOELASTIC PRODUCTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: HEALON, HEALON GV AND HEALON5 SODIUM HYALURONATE AND IS INTENDED TO BE INTRODUCED INTO THE EYE TO AID PERFORMANCE OF SURGERY, SUCH AS TO MAINTAIN ANTERIOR CHAMBER DEPTH, PRESERVE TISSUE INTEGRITY, PROTECT TISSUE FROM SURGICAL TRAUMA, OR FUNCTION AS A TAMPONADE DURING RETINAL REATTACHMENT.
P880086|S139|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ZEPHYR PULSE GENERATORS MODELS XL DR 5826,DR5820 & SR 5620|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2006|03/29/2007|||APPR|APPROVAL FOR THE ZEPHYR PULSE GENERATORS MODELS: XL DR 5826, DR 5820 AND SR 5620.  THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS.  RATE MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.  DUAL-CHAMBER PACING (MODELS 5826, 5820 ONLY) IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME, CHRONIC SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK, RECURRENT ADAMS-STOKES SYNDROME, OR SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.  ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS.  VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARREST, CHRONIC ATRIAL FIBRILLATION, SEVERE PHYSICAL DISABILITY.  AF SUPPRESSION (MODELS 5826, 5820 ONLY) IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P990066|S027|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/2006|04/13/2007|||APPR|APPROVAL FOR A CHANGE IN THE ACCEPTANCE CRITERIA FOR THE DETECTORS.
P810006|S026|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2006|01/09/2007|||OK30|CHANGE IN MANUFACTURING PROCESS FOR A QC RELEASE TEST FOR FINISHED DEVICES USED IN THE COLLAGEN PURIFICATION PROCESS.
P850010|S023|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2006|01/09/2007|||OK30|CHANGE IN MANUFACTURING PROCESS FOR A QC RELEASE TEST FOR FINISHED DEVICES USED IN THE COLLAGEN PURIFICATION PROCESS.
P910023|S129|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST JUDE MEDICAL ICDS & CRT-DS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2006|01/11/2007|||OK30|USE OF AN AUTOMATED HYDROHONE CLEANING MACHINE IN ICD AND CRT-D PRODUCTION.
P030054|S047|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST JUDE MEDICAL ICDS & CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2006|01/11/2007|||OK30|USE OF AN AUTOMATED HYDROHONE CLEANING MACHINE IN ICD AND CRT-D PRODUCTION.
P040002|S008|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2006|01/18/2007|||OK30|ADDING AN ADDITIONAL NON-DESTRUCTIVE LOAD TEST.
P950037|S048|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2006|03/08/2007|||APPR|APPROVAL FOR AN ADDITIONAL TRADE NAME FOR THE MARKET APPROVED SETROX S LEAD, AS WELL AS MINOR CHANGES TO THE ACCESSORIES, PACKAGING, AND LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXTRUS, AND LABELED FOR DISTRIBUTION BY GUIDANT.  THE DEXTRUS LEAD IS INDICATED FOR PERMANENT PACING AND SENSING IN EITHER THE RIGHT ATRIUM OR RIGHT VENTRICLE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS.
P980035|S070|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700 IPG, KAPPA 900 IPG, ENPULSE IPG, ADAPATA/ VERSA/ SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2006|01/11/2007|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P980016|S093|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2006|01/11/2007|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P010031|S060|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC ICD|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2006|01/11/2007|||OK30|REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
P030053|S001|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORY GEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/14/2006|05/17/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY
P040001|S004|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM|NQO|OR|30-Day Notice||N|12/14/2006|12/29/2006|||OK30|TRANSFER OF RECEIVING, INSPECTION, ACCEPTANCE OF FINISHED GOODS, WAREHOUSING AND DISTRIBUTION FUNCTIONS TO THE NEW HEADQUARTERS FACILITY.
P000029|S020|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/14/2006|04/19/2007|||APPR|APPROVAL FOR A LABELING CHANGE TO DELETE THE CONTRAINDICATION FOR DEFLUX IN DUPLEX SYSTEMS, AND TO REPLACE IT WITH A PRECAUTION.
P970003|S075|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/15/2006|02/12/2007|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY.
P000025|S021|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|SONATATI100 COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/2006|06/22/2007|||APPR|APPROVAL FOR THE SONATATI100 COCHLEAR IMPLANT AND IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: ADULTS EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE BILATERAL, SENSORINEURAL HEARING IMPAIRMENT AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS. THESE INDIVIDUALS TYPICALLY DEMONSTRATE BILATERAL SEVERE TO PROFOUND SENSORINEURAL HEARING LOSS DETERMINED BY A PURE TONE AVERAGE OF 70 DB OR GREATER AT 500 HZ, 1000 HZ, AND 2000 HZ. LIMITED BENEFIT FROM AMPLIFICATION IS DEFINED BY TEST SCORES OF 40% CORRECT OR LESS IN BEST-AIDED LISTENING CONDITION ON CD RECORDED TESTS OF OPEN-SET SENTENCE RECOGNITION (HEARING IN NOISE TEST [HINT] SENTENCES).  CHILDREN AGED TWELVE (12) MONTHS TO SEVENTEEN (17) YEARS ELEVEN (11) MONTHS MUST DEMONSTRATE A PROFOUND, BILATERAL SENSORINEURAL HEARING LOSS WITH THRESHOLDS OF 90 DB OR GREATER AT 1000 HZ. IN YOUNGER CHILDREN, LITTLE OR NO BENEFIT IS DEFINED BY LACK OF PROGRESS IN THE DEVELOPMENT OF SIMPLE AUDITORY SKILLS IN CONJUNCTION WITH APPROPRIATE AMPLIFICATION AND PARTICIPATION IN INTENSIVE AURAL HABILITATION OVER A THREE (3) TO SIX (6) MONTH PERIOD. IN OLDER CHILDREN, LACK OF AID BENEFIT IS DEFINED AS < 20% CORRECT ON THE MULTI-SYLLABIC LEXICAL NEIGHBOURHOOD TEST (MLNT) OR LEXICAL NEIGHBOURHOOD TEST (LNT), DEPENDING UPON THE CHILD'S COGNITIVE ABILITY AND LINGUISTIC SKILLS. A THREE (3) TO SIX (6) MONTH HEARING AID TRIAL IS REQUIRED FOR CHILDREN WITHOUT PREVIOUS EXPERIENCE WITH HEARING AIDS.  RADIOLOGICAL EVIDENCE OF COCHLEAR OSSIFICATION MAY JUSTIFY A SHORTER TRIAL WITH AMPLIFICATION.
P990046|S016|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/15/2006|12/11/2007|||APPR|APPROVAL FOR THE ATS OPEN PIVOT BILEAFLET HEART VALVE MODELS AP360.
P010038|S013|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECONDLOOK (SL) CAD|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2006|12/07/2010|||APPR|APPROVAL FOR THE SECONDLOOK V7.2 CAD SYSTEM.
P980023|S027|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2006|01/26/2007|||APPR|APPROVAL FOR LEADS BASED ON THE LINOX SD AND LINOX TD LEADS WITH ONE SHOCK COIL INSTEAD OF TWO SHOCK COILS.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES LINOX S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD AND LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD AND ARE INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD.  CURRENTLY, DATA IS NOT AVAILABLE REGARDING THE USE OF THESE LEAD SYSTEMS WITH ICDS OF OTHER MANUFACTURERS. USE OF OTHER ICDS MAY ADVERSELY AFFECT SENSING AND/OR THERAPY DELIVERY.
P040014|S005|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|IBI THERAPY CARDIAC ABLATION SYSTEM ERS/1500T RF GENERATOR|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2006|07/13/2007|||APPR|APPROVAL FOR A CHANGE FROM LOT RELEASE TO PARAMETRIC RELEASE.
P040042|S007|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CARDIAC ABLATION SYSTEM|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2006|07/13/2007|||APPR|APPROVAL FOR A CHANGE FROM LOT RELEASE TO PARAMETRIC RELEASE.
P990080|S013|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|ARRAY MULTIFOCAL FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER IOL, CEEON 911A & 913A, TECNIS Z9000 & Z9001|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2006|01/16/2007|||OK30|ALTERNATE SUPPLIER (ACROS ORGANICS) FOR ONE OF THE COMPONENTS OF THE SILICONE RAW MATERIALS, OCTAPHENYLTETRA-METHYLOXANE.
P990080|S014|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIORCHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A & 913A, TECNIS Z9000 & Z9001|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2006|01/16/2007|||OK30|IMPLEMENTATION OF A SAMPLE MODULATION TRANSFER FUNCTION INSPECTION FOR LENS MODEL ZA9003.
P990080|S015|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A ,913A & TECNIS Z9000, Z9001|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2006|01/16/2007|||OK30|CHANGE TO A FIXTURE USED IN THE SHEET CASTING PROCESS FOR THE FOLDABLE AND SOFT ACRYLIC INTRAOCULAR LENSES.
P980040|S009|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2006|01/16/2007|||OK30|CHANGE TO A FIXTURE USED IN THE SHEET CASTING PROCESS FOR THE FOLDABLE AND SOFT ACRYLIC INTRAOCULAR LENSES.
P990080|S016|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A,913A & TECNIS Z9000 & Z9001|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2006|01/16/2007|||OK30|USE OF NEW EQUIPMENT IN THE MANUFACTURE OF THE SOFT ACRYLIC INTRAOCULAR LENSES.
P980040|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2006|01/16/2007|||OK30|USE OF NEW EQUIPMENT IN THE MANUFACTURE OF THE SOFT ACRYLIC INTRAOCULAR LENSES.
P040038|S008|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2006|01/19/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE PROCESSES AND COMPONENTS USED TO MANUFACTURE THE STENT DELIVERY SYSTEM HANDLE.
P020050|S005|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2006|04/09/2007|||APPR|APPROVAL FOR A CHANGE IN THE REPETITION RATE FROM 200 HZ TO 400 HZ.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 DIOPTERS (D) AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 2) THE WAVEFRONT-GUIDED (WFG) REDUCTION OR ELIMINATION OF UP TO -7.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 D OF SPHERICAL COMPONENT AND UP TO 3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P030008|S005|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2006|04/09/2007|||APPR|APPROVAL FOR A CHANGE IN THE REPETITION RATE FROM 200 HZ TO 400 HZ.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 DIOPTERS (D) AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 2) THE WAVEFRONT-GUIDED (WFG) REDUCTION OR ELIMINATION OF UP TO -7.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 D OF SPHERICAL COMPONENT AND UP TO 3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P950022|S034|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2006|03/08/2007|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1)MODIFICATION TO THE CRIMP SLUG WELD TAB 2) MODIFICATION TO THE DISTAL HEADER ASSEMBLY 3) MODIFICATION TO THE PTFE LINER IN THE IS-1 CONNECTOR LEG 4) REMOVAL OF THE PTFE LINERS IN THE TWO DF-1 CONNECTOR LEGS 5) ADDITION OF A DF-1 PLUG ACCESSORY TO THE LEAD PACKAGE 6) ADDITION OF AN EXTRA-SOFT STYLET ACCESSORY TO THE LEAD PACKAGE 7) MINOR MODIFICATIONS TO THE USER MANUAL 8) MODIFIED RADIUS SPECIFICATION FOR THE SPRING STOPPER COMPONENT.
P990027|S009|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2006|02/01/2008|||APPR|APPROVAL FOR THE EXPANSION OF THE PHYSICIAN ADJUSTMENT RANGE FOR THE SPHERICAL COMPONENT ROM +2.5 D TO -1.0 D.
P930014|S019|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF SINGLE PIECE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2006|06/15/2007|||APPR|APPROVAL OF AN ALTERNATE MANUFACTURING FACILITY IN CORK, IRELAND.
P990020|S023|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2006|01/18/2007|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF STENT GRAFT COMPONENTS.
P990080|S017|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A, 913A & TECNIS Z9000,Z9001|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2006|01/16/2007|||OK30|CHANGE OF EXISTING BELT SEALERS TO A NEWER MODEL.
P990080|S018|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|FOLDABLE ULTAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A,913A 7 TECNIS Z9000,Z9001|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2006|01/16/2007|||OK30|CHANGE IN THE PURIFICATION STEP FOR ONE OF THE COMPONENTS OF THE SILICONE RAW MATERIALS.
P830045|S105|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON/PHOENIX FAMILY OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2006|05/09/2007|||APPR|APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
P880006|S048|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2006|05/09/2007|||APPR|APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
P880086|S140|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTERNITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2006|05/09/2007|||APPR|APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
P970013|S015|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2006|05/09/2007|||APPR|APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
P020022|S005|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2006|08/01/2007|||APPR|APPROVAL FOR TRANSFER OF THE MANUFACTURE OF THE WASH REAGENTS (WASH A AND WASH B) TO A CONTRACT MANUFACTURER.  THE NUMBER OF BOTTLES PER LOT WILL BE INCREASED FOR BOTH WASH A AND WASH B.
P030053|S002|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/2006|02/08/2008|||APPR|APPROVAL FOR A CHANGE TO A LOW BLEED PATCH DESIGN FOR THE DEVICE.
P890003|S115|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS PAVEMAKERS, CARELINK MONITOR, CARDIOSIGHT READER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2006|01/30/2007|||APPR|APPROVAL FOR THE MEDTRONIC MODELS 2490G (REV. T APPLICATION SOFTWARE VERSION 5V3); MEDTRONIC 2020A CARDIOSIGHT READER (APPLICATION SOFTWARE VERSION 5V3); AND MEDTRONIC 2491 DDMA SOFTWARE.  THE MEDTRONIC 2491 DDMA SOFTWARE CONTAINS THE XML TRANSLATION UTILITY (XMLTU) SOFTWARE VERSION V17, THE PRESENTING WAVEFORM UTILITY (PWF) SOFTWARE VERSION 16V1, AND THE SESSION DATA DECODE (SDD) SOFTWARE VERSION 1V2.
P980035|S071|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SELECTED FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2006|01/30/2007|||APPR|APPROVAL FOR THE MEDTRONIC MODELS 2490G (REV. T APPLICATION SOFTWARE VERSION 5V3); MEDTRONIC 2020A CARDIOSIGHT READER (APPLICATION SOFTWARE VERSION 5V3); AND MEDTRONIC 2491 DDMA SOFTWARE.  THE MEDTRONIC 2491 DDMA SOFTWARE CONTAINS THE XML TRANSLATION UTILITY (XMLTU) SOFTWARE VERSION V17, THE PRESENTING WAVEFORM UTILITY (PWF) SOFTWARE VERSION 16V1, AND THE SESSION DATA DECODE (SDD) SOFTWARE VERSION 1V2.
P010031|S061|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2006|01/30/2007|||APPR|APPROVAL FOR THE MEDTRONIC MODELS 2490G (REV. T APPLICATION SOFTWARE VERSION 5V3); MEDTRONIC 2020A CARDIOSIGHT READER (APPLICATION SOFTWARE VERSION 5V3); AND MEDTRONIC 2491 DDMA SOFTWARE.  THE MEDTRONIC 2491 DDMA SOFTWARE CONTAINS THE XML TRANSLATION UTILITY (XMLTU) SOFTWARE VERSION V17, THE PRESENTING WAVEFORM UTILITY (PWF) SOFTWARE VERSION 16V1, AND THE SESSION DATA DECODE (SDD) SOFTWARE VERSION 1V2.
P030025|S043|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2006|05/10/2007|||APPR|APPROVAL FOR AN ALTERNATE METHOD FOR LOADING DIE TEMPERATURE, HEAT TIME, AND PRODUCTION LINE SETTINGS FOR THE DISTAL HEAT SHRINK PROCESS USED IN MANUFACTURING OF THE DEVICES AT THE GALWAY, IRELAND MANUFACTURING SITE.
P020009|S035|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2006|05/10/2007|||APPR|APPROVAL FOR AN ALTERNATE METHOD FOR LOADING DIE TEMPERATURE, HEAT TIME, AND PRODUCTION LINE SETTINGS FOR THE DISTAL HEAT SHRINK PROCESS USED IN MANUFACTURING OF THE DEVICES AT THE GALWAY, IRELAND MANUFACTURING SITE.
P040016|S021|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2006|05/10/2007|||APPR|APPROVAL FOR AN ALTERNATE METHOD FOR LOADING DIE TEMPERATURE, HEAT TIME, AND PRODUCTION LINE SETTINGS FOR THE DISTAL HEAT SHRINK PROCESS USED IN MANUFACTURING OF THE DEVICES AT THE GALWAY, IRELAND MANUFACTURING SITE.
P010062|S005|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS|NUU|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2006|02/01/2007|||APPR|APPROVAL FOR REMOVING UNIVAL D-49 FROM THE FORMULATION FOR OPRIFOCON A, AND THE REQUESTED LABELING CHANGES.
P040012|S025|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK & ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2006|01/18/2007|||OK30|CHANGE TO THE FINAL VISUAL INSPECTION PROCESS.
P910023|S130|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2006|01/19/2007|||OK30|MODIFICATIONS TO THE AUTOMATED TEST SOFTWARE USED FOR COMPONENT/ SUBASSEMBLY AND DEVICE LEVEL TESTING.
P030054|S048|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2006|01/19/2007|||OK30|MODIFICATIONS TO THE AUTOMATED TEST SOFTWARE USED FOR COMPONENT/ SUBASSEMBLY AND DEVICE LEVEL TESTING.
P880003|S089|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|DURA STAR RX PTCA BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/2006|08/29/2007|||APPR|APPROVAL FOR A NEW CATHETER MODEL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DURA STAR RX PTCA BALLOON DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  IN ADDITION, THE DURA STAR RX PTCA DILATATION CATHETER IS INDICATED FOR POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P830045|S106|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON/PHOENIX FAMILY OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2006|05/04/2007|||APPR|APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
P880006|S049|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2006|05/04/2007|||APPR|APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
P880086|S141|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2006|05/04/2007|||APPR|APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
P970013|S016|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2006|05/04/2007|||APPR|APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE).
P000058|S021|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBER TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2006|07/03/2007|||APPR|APPROVAL FORA NEW TEST METHOD FOR THE QUANTITATIVE ANALYSIS OF POLYSORBATE-80 EXCIPIENT FOR THE RELEASE OF RHBMP-2.
P000054|S010|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2006|07/03/2007|||APPR|APPROVAL FORA NEW TEST METHOD FOR THE QUANTITATIVE ANALYSIS OF POLYSORBATE-80 EXCIPIENT FOR THE RELEASE OF RHBMP-2.
P000027|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA CALSET AND|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2006|01/19/2007|||OK30|CHANGE IN THE LABELING IN THE PRECAUTIONS AND WARNINGS SECTION, CONCERNING THE TESTING OF POTENTIALLY INFECTIOUS HUMAN-DERIVED MATERIAL USED IN THE ASSAY.
P040013|S009|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S (GROWTH ENHANCED MATRIX)|NPZ|DE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2006|08/10/2007|||APPR|APPROVAL FOR THE NEW REFERENCE STANDARD, WHICH IS USED IN THE FOLLOWING ANALYTICAL METHODS: RP-HPLC, SEC, SDS-PAGE, UV, BIOASSAY, ELISA, AND PHH.
P040038|S009|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2006|01/25/2007|||OK30|REVISION OF THE STERILIZATION LOAD CONFIGURATION FOR THE CAROTID STENT SYSTEMS, AND INTRODUCTION OF A SYSTEM FOR THE CONTROL OF MANDRELS.
P790018|S047|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2006|01/24/2007|||OK30|USE OF AN ALTERNATE CONDUIT COMPONENT FOR THE MEDTRONIC HALL CONDUIT.
P010014|S014|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2006|08/05/2011|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT BIOMET ORTHOPEDICS, INC., IN WARSAW, INDIANA, AND STERIS INC., LOCATED AT  ISOMEDIX SERVICES, IN LIBERTYVILLE, ILLINOIS.
P040033|S003|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2006|10/14/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SMITH & NEPHEW ORTHOPAEDICS LTD., WARWICKSHIRE, UNITED KINGDOM, TO PERFORM FINAL MACHINING, AND A MANUFACTURING SITE LOCATED AT LPE MEDICAL LTD., HAMPSHIRE, UNITED KINGDOM.
P000053|S007|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|SPHINCTER 800 URINARY CONTROL SYSTEM|EZY|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/26/2006|02/07/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880003|S090|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|FIRE STAR RX PTCA BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/28/2006|08/31/2007|||APPR|APPROVAL FOR A NEW CATHETER MODEL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FIRE STAR RX PTCA BALLOON DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION FOR THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
P990056|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA  CALSET|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2006|01/19/2007|||OK30|CHANGE IN THE LABELING IN THE PRECAUTIONS AND WARNINGS SECTION, CONCERNING THE TESTING OF POTENTIALLY INFECTIOUS HUMAN-DERIVED MATERIAL USED IN THE ASSAY.
P840001|S095|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/28/2006|03/07/2007|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE FEEDTHROUGH AND FOR THE USE OF ACETONE FOR THE REMOVAL AND REPLACEMENT OF THE CONNECTOR BLOCK IN THE MANUFACTURING REWORK PROCESS.
P990043|S010|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/2006|01/19/2007|||OK30|CHANGE IN THE MANUFACTURING OF A RAW MATERIAL.
P990044|S008|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-CORE-IGMK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/2006|01/19/2007|||OK30|CHANGE IN THE MANUFACTURING OF A RAW MATERIAL.
P990041|S009|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-AB-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/2006|01/19/2007|||OK30|CHANGE IN THE MANUFACTURING OF A RAW MATERIAL.
P000013|S008|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEONICS ABC / TRIDENT SYSTEMS|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/29/2006|04/26/2007|||APPR|APPROVAL FOR A NEW LOCKING MECHANISM DESIGN FOR THE TRIDENT ACETABULAR SYSTEM (TRIDENT ALUMINA INSERTS AND TRIDENT ACETABULAR SHELLS), AS WELL AS ASSOCIATED REVISIONS TO THE PACKAGE INSERT.  THIS DESIGN MODIFICATION IS INTENDED TO ALLOW FOR EASE OF INSERTION OF THE ALUMINA CERAMIC INSERT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRIDENT II ACETABULAR SYSTEM (TRIDENT II ALUMINA INSERTS, TRIDENT II ACETABULAR SHELLS) AND IS INDICATED FOR PATIENTS REQUIRING PRIMARY OR REVISION TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (OSTEOARTHRITIS, AVASCULAR NECROSIS, TRAUMATIC ARTHRITIS, SLIPPED CAPITAL EPIPHYSIS, PELVIC FRACTURE, FEMORAL FRACTURE, FAILED FRACTURE FIXATION, OR DIASTROPHIC VARIANT), OR INFLAMMATORY JOINT DISEASE.
P020040|S002|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 8|POB 58165|TEL-AVIV||61581||STENT, CORONARY|NIRFLEX PREMOUNTED CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2007|02/02/2007|||OK30|CHANGE TO THE ETO LOAD CONFIGURATION FOR STERILIZATION OF THE DEVICE.
P020040|S003|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 8|POB 58165|TEL-AVIV||61581||STENT, CORONARY|NIRFLEX PREMOUNTED CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2007|02/02/2007|||OK30|CHANGE IN THE WELDING PROCESS IN THE MANUFACTURE OF THE DEVICE.
P950020|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON)|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2007|02/02/2007|||OK30|CHANGE IN THE STERILIZATION METHOD AS WELL AS A CHANGE IN DIMENSIONS OF THE OUTER SHIPPING BOX FOR THE CUTTING BALLOON.
P050012|S006|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM STS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2007|01/23/2007|||OK30|REVISED FINAL RELEASE MANUFACTURING SOFTWARE AND TEST PROCEDURE TO IMPROVE PROCESS CONTROLS, AND PROPOSED FINAL RELEASE CRITERIA MODIFICATION FOR THE STS SENSOR.
P890057|S019|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR|LSZ|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|01/03/2007|04/25/2007|||APPR|APPROVAL FOR THE MODIFICATION OF THE BREATHING CIRCUIT TO INCLUDE TWO FILTERS, ONE IN THE INSPIRATORY LIMB AFTER THE GAS SUPPLY LINE AND RELIEVE VALVE AND ANOTHER AT THE EXPIRATORY LIMB BEFORE THE DUMP VALVE.
P050033|S001|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|COSMETIC TISSUE AUGMENTATION PRODUCT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/2007|07/16/2007|||APPR|APPROVAL FOR: 1) AN INCREASE N THE BUFFER CONCENTRATION OF THE FINAL PRODUCT FROM 12 MM TO 50 MM SODIUM PHOSPHATE; 2) THE INTRODUCTION OF AN ANTIOXIDANT, I.E., 0.1% SODIUM METABISULFITE, INTO THE FINAL PRODUCT; AND 3) THE INTRODUCTION OF AN 0.5 ML CONFIGURATION OF COSMETIC TISSUE AUGMENTATION PRODUCT (CTA).
P040043|S012|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|12/06/2006|01/05/2007|||OK30|CHANGE IN THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE.
P030052|S002|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/08/2007|02/06/2007|||APPR|APPROVAL FOR THE ADDITION OF THE THERMOBRITE AUTOMATED SLIDE HEATING PLATE SUPPLIED BY AN ALTERNATE VENDOR AS AN OPTIONAL ALTERNATIVE OF THE HYBRITE AUTOMATED SLIDE HEATING PLATE INSTRUMENT AND TO ADD INSTRUCTIONS FOR USE OF SAID THERMOBRITE TO THE CURRENT UROVYSION BLADDER CANCER KIT PACKAGE INSERT.
P990020|S024|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX  AAADAVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/09/2007|02/15/2007|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE GRAFT COVER ASSEMBLY USED IN THE DEVICE.
P910077|S068|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/11/2007|03/23/2007|||APPR|APPROVAL FOR SOFTWARE UPDATES TO 1) CHANGE THE CURRENT WEIGHT ALERT ALGORITHM TO REDUCE OVER-REPORTING OF WEIGHT ALERTS; AND 2) TO CORRECT A DETECTION FAILURES DUE TO DIFFERING TIME ZONE CHANGES.
P050042|S002|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/11/2007|03/05/2007|||APPR|APPROVAL TO EXTEND THE EXPIRATION DATING OF REAGENTS, CALIBRATORS, AND CONTROLS TO 14 MONTHS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT ANTI-HCV AND IS INDICATED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).
P970021|S014|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track|Labeling Change - PAS|N|01/11/2007|07/06/2007|||APPR|APPROVAL FOR REVISED PROFESSIONAL LABELING TO INCLUDE THE RESULTS OF A MULTI-CENTER STUDY OF THE GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY (UBT) SYSTEM.
P950037|S049|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS MODELS OF PHILOS/AXIOS/PROTOS/CYLOS PG'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/11/2007|03/26/2007|||APPR|APPROVAL FOR: 1) UPDATES TO THE INTEGRATED CIRCUIT USED FOR ELECTROGRAM SENSING AND NON-RATE RESPONSIVE PACEMAKER TIMING, 2) MODIFICATIONS TO THE ELECTRONIC MODULE, AND 3) IMPLEMENTATION OF MULTI-LINGUAL LABELING.
P810006|S027|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2007|02/09/2007|||OK30|ALTERNATE ALKALI TREATMENT PRODUCTION AREA.
P850010|S024|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2007|02/09/2007|||OK30|ALTERNATE ALKALI TREATMENT PRODUCTION AREA.
P840062|S012|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2007|02/09/2007|||OK30|ALTERNATE ALKALI TREATMENT PRODUCTION AREA.
P900033|S015|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2007|02/09/2007|||OK30|ALTERNATE ALKALI TREATMENT PRODUCTION AREA.
P970004|S040|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM TINED LEAD MODELS 3889 & 3093|EZW|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|01/12/2007|10/23/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P810032|S053|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|MULTI-PIECE PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2007|02/09/2007|||OK30|CHANGE IN THE J.D. EDWARDS SOFTWARE MODULE TO ALLOW USERS TO IDENTIFY THE LOCATION OF A LOT OF RAW MATERIAL WHICH HAS EXPIRED.
P020040|S004|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 8|POB 58165|TEL-AVIV||61581||STENT, CORONARY|NIRFLEX PREMOUNTED CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2007|02/15/2007|||OK30|CHANGE TO THE PCD CONFIGURATION USED DURING THE ETO STERILIZATION PROCESS AND REMOVAL TIMING FOR THE INCUBATION OF THE BIS USED DURING THE ETO STERILIZATION PROCESS.
P010003|S009|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/2007|02/12/2007|||APPR|APPROVAL FOR ADDITIONAL PRECAUTIONARY STATEMENTS, AND OTHER MINOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE OF THE CARTRIDGE AND SYRINGE LABELS.
P960040|S140|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY & VITALITY AVT FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2007|02/15/2007|||OK30|MODIFICATIONS TO SEVERAL DEVICE FUNCTIONAL TESTS.
P020040|S005|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 8|POB 58165|TEL-AVIV||61581||STENT, CORONARY|NIRFLEX PREMOUNTED CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2007|02/15/2007|||OK30|USE OF AN AUTOMATED STENT-WEIGHING MACHINE DURING THE MANUFACTURE OF THE NIRFLEX STENT.
P010012|S146|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK & RENEWAL FAMILIES OF CRT-DS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2007|03/28/2007|||APPR|APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED  APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.
P960040|S141|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM & VITALITY FAMILIES OF ICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2007|03/28/2007|||APPR|APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED  APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.
P980016|S094|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ENTRUST 35J & VIRTUOSO ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2007|03/15/2007|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE BATTERY CONNECTOR MODULE FOR ENTRUST 35J, CONCERTO, AND VIRTUOSO ICDS.
P010031|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO ICD|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2007|03/15/2007|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE BATTERY CONNECTOR MODULE FOR ENTRUST 35J, CONCERTO, AND VIRTUOSO ICDS.
P910077|S071|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2007|03/28/2007|||APPR|APPROVAL FOR THE LATITUDE SYSTEM SOFTWARE, VERSION 2.1 (MODEL 6488) THAT CONTAINS REGULATED  APPLICATION SERVER (RAS) SOFTWARE, VERSION 2.1.1 AND WEB APPLICATION SERVER (WAS) SOFTWARE, VERSION 2.1.1.
P990033|S014|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15, PEPGEN P-15 FLOW & PEPGEN P-15 PUTTY|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2007|08/09/2007|||APPR|APPROVAL TO RELOCATE THE MANUFACTURING SITE TO DENTSPLY SPECIALTY MATERIALS LOCATED IN YORK PENNSYLVANIA.
P960040|S142|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/16/2007|||OK30|CHANGES TO THE SOLDER BALL INSPECTION TESTING PROCESS.
P010012|S147|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/16/2007|||OK30|CHANGES TO THE SOLDER BALL INSPECTION TESTING PROCESS.
P030005|S041|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/16/2007|||OK30|CHANGES TO THE SOLDER BALL INSPECTION TESTING PROCESS.
P050049|S001|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM HBSAG ASSAY|LOM|MI|30-Day Notice||N|01/17/2007|02/05/2007|||OK30|CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
P060003|S003|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/05/2007|||OK30|CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
P060009|S001|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT: 09VB BLDG: AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE-M 2.0 & AXSYM CORE-M 2.0 CONTROLS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/05/2007|||OK30|CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
P980007|S008|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ABBOTT IMX FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/01/2007|||OK30|CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
P970027|S005|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTIBODY TO HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/05/2007|||OK30|CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
P060012|S001|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0 & AXSYM CORE 2.0 CONTROLS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/05/2007|||OK30|CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
P910007|S016|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMX PSAS|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/01/2007|||OK30|CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
P820060|S021|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT  AFP-EIA DIAGNOSTIC KIT|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2007|02/01/2007|||OK30|CONSOLIDATION OF SECONDARY PACKAGING OPERATIONS FROM BUILDING K2 LOCATED IN THE K-COMPLEX TO BUILDING AP32 LOCATED IN ABBOTT PARK.
P020047|S008|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2007|02/16/2007|||OK30|MODIFICATION IN THE DOSE RANGE AND CONVEYOR SPEED FOR E-BEAM STERILIZATION FOR THE MULTI-LINK AND MULTI-LINK VISION CORONARY STENT SYSTEMS.
P970020|S048|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK VISION CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2007|02/16/2007|||OK30|MODIFICATION IN THE DOSE RANGE AND CONVEYOR SPEED FOR E-BEAM STERILIZATION FOR THE MULTI-LINK AND MULTI-LINK VISION CORONARY STENT SYSTEMS.
P040037|S003|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/19/2007|04/24/2007|||APPR|APPROVAL FOR THE ADDITION OF A 5 MM DIAMETER ENDOPROSTHESIS.
P970003|S076|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/22/2007|06/29/2007|||APPR|APPROVAL FOR THE VNS THERAPY DEMIPULSE, MODEL 103 GENERATOR AND VNS THERAPY DEMIPULSE DUO, MODEL 104 GENERATOR.
P950037|S050|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS DR-T AND CYLOS DR-T|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2007|02/13/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE CARDIOMESSENGER AND CARDIOMESSENGER II USED WITH THE REFERENCED DEVICES.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: CARDIOMESSENGER TLINE AND CARDIOMESSENGER II LLT AND ARE INDICATED FOR TRANSMITTING DIAGNOSTIC PATIENT DATA FROM THE DEVICE TO THE PHYSICIAN.
P050023|S003|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX CRT DEVICE & CARDIOMESSENGER II|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2007|02/13/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE CARDIOMESSENGER AND CARDIOMESSENGER II USED WITH THE REFERENCED DEVICES.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: CARDIOMESSENGER TLINE AND CARDIOMESSENGER II LLT AND ARE INDICATED FOR TRANSMITTING DIAGNOSTIC PATIENT DATA FROM THE DEVICE TO THE PHYSICIAN.
P950020|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CUTTING BALLOON ULTRA2 MONORAIL|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2007|02/23/2007|||OK30|ADDITION OF IN-PROCESS AND POST-STERILE DESTRUCTIVE PULL TESTS.
P980049|S025|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/2007|06/29/2007|||APPR|APPROVAL FOR THE ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE.
P900022|S008|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|ORCHESTRA PLUS PROGRAMMER & ELAVIEW 2.02 UG1 PROGRAMMING SOFTWARE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/2007|06/29/2007|||APPR|APPROVAL FOR THE ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE.
P950029|S030|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|ORCHESTRA PLUS PROGRAMMER & ELAVIEW 2.02 UG1 PROGRAMMING SOFTWARE|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/2007|06/29/2007|||APPR|APPROVAL FOR THE ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE.
P010015|S026|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC ATTAIN OVER THE WIRE (OTW) LEFT VENTRICULAR LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2007|02/23/2007|||OK30|MINOR CHANGES TO THE CONNECTOR ASSEMBLY.
P990020|S025|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2007|02/23/2007|||OK30|CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE AN ALTERNATIVE LOCATION FOR A CATHETER COATING OPERATION.
P040048|S002|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2007|06/08/2007|||APPR|APPROVAL FOR THE ADDITION OF THE ZIMMER MANUFACTURING B.V. FACILITY LOCATED IN PONCE, PUERTO RICO AS AN ALTERNATIVE SITE FOR MANUFACTURING THE VERSYS HERITAGE FEMORAL STEMS.
P060001|S001|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2007|07/17/2007|||APPR|APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS: 1) TO INCLUDE AN ALTERNATE THREE(3)-PALLET STERILIZATION CHAMBER AND 2) TO REDUCE THE FREQUENCY OF PYROGEN TESTING.
P000012|S012|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HEPTATIS C VIRUS (HCV) TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2007|02/28/2007|||OK30|MANUFACTURING SCALE-UP OF A RAW MATERIAL VENDOR, CONVERSION OF A MANUFACTURING ROOM TO A MORE RESTRICTIVE ENVIRONMENT, AND INSTALLATION OF A NEW LABELING SYSTEM.
P990046|S017|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT? BILEAFLET HEART VALVE 35 MM MITRAL VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/30/2007|07/23/2007|||APPR|APPROVAL FOR A CUFF CHANGE TO ADD THE 35 MM MITRAL VALVE TO THE APPROVED MITRAL VALVE SIZES.
P980044|S006|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2007|03/07/2007|||APPR|APPROVAL FOR ADDING BOTH POSSIBLE ADVERSE REACTIONS REPORTED WORLDWIDE TO THE INSTRUCTION FOR USE, AND THE POSSIBLE SIDE EFFECTS COLLECTED FROM WORLDWIDE POST-MARKET EXPERIENCE TO THE PATIENT INFORMATION BROCHURE.
P060001|S002|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & RX CAROTID STENT SYSTEMS|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2007|07/17/2007|||APPR|APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE ALTERNATE PROCESS CHALLENGE DEVICES (PCD).
P020056|S001|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|INAMED SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Express GMP Supplement|N|01/31/2007|08/22/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE IN LA AURORA DE HEREDIA, COSTA RICA.
P860019|S219|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK MONORAIL PTCA CATHETER SYSTEM|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2007|03/02/2007|||OK30|INCREASE IN A PARAMETER LIMIT FOR THE PROXIMAL LASER WELD PROCESS.
P040022|S003|Medtronic Vascular|37A Cherry Hill Drive||Danvers|MA|01923||Device, hemostasis, vascular|ANGIOLINK VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2007|05/24/2007|||APPR|APPROVAL FOR INCORPORATION OF THE FOLLOWING PROCESSING AND MATERIAL CHANGES TO THE DISTAL END OF THE VCS 1000 DILATOR: 1) CHANGE IN THE DILATOR MATERIAL FROM NYLON 11 TO PEBAX NYLON 4033 FOR THE DILATOR DISTAL TIP AND FROM NYLON 11 TO PEBAX NYLON 6033 FOR THE DILATOR DISTAL SHAFT; 2) ADDITION OF A RF AND/OR ALTERNATIVE THERMAL ENERGY SOURCE TO BOND THE DILATOR DISTAL TIP TO THE DISTAL SHAFT; AND 3) ADDITION OF A HEAT SHRINK SLEEVE TO ENHANCE THE BOND BETWEEN THE SHAFT AND THE DISTAL TIP.
P030030|S005|C.R. Bard, Inc.|13183 HARLAND DRIVE||COVINGTON|GA|30014|6421|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|BARD TEGRESS URETHRAL IMPLANT|LNM|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/2007|02/16/2007|||APPR|APPROVAL FOR CHANGES TO THE TEGRESS URETHRAL IMPLANT INSTRUCTIONS FOR USE AND PATIENT INFORMATION BROCHURE TO MINIMIZE THE INCIDENCE OF ADVERSE EVENTS (E.G., EROSION AND NECROSIS) AND ENHANCE THE SAFETY OF DEVICE USE.
P030054|S049|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/2007|07/25/2007|||APPR|APPROVAL FOR DISTAL TIP MODIFICATIONS TO THE QUICKSITE LEAD FAMILY TO REDUCE THE LENGTH OF RIGID SECTIONS AND INCREASE LEAD FLEXIBILITY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS.  QUICKFLEX LEADS ARE 6 FRENCH, TRANSVENOUS, STEROID ELUTING, BIPOLAR, IS-1 COMPATIBLE, S-SHAPED CURVE, PASSIVE FIXATION LEADS INTENDED FOR PERMANENT SENSING AND PACING OF THE LEFT VENTRICLE WHEN USED WITH A COMPATIBLE ST. JUDE MEDICAL?S BIVENTRICULAR SYSTEM.
P910066|S023|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2007|06/28/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE CONTROL BOX FOR THE OL1000, OL1000 SINGLE COIL (SIZE 2/3/4), AND SPINALOGIC DEVICES INCLUDING ENLARGED LCD ICON GRAPHICS AND PROMPTS, 9 VOLT ALKALINE BATTERY POWER SOURCE, AND UPDATED DEVICE SOFTWARE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS.  THE OL1000 AND OL1000 SC DEVICES ARE INTENDED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES.  THE SPINALOGIC DEVICE IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
P050012|S007|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM STS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2007|02/26/2007|||OK30|EXPANSION OF SUBCOMPONENT AND COMPONENT MANUFACTURING PROCESSES OF THE STS SYSTEM TO A SECOND FACILITY.
P030026|S012|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR|LOM|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|02/07/2007|03/05/2007|||APPR|APPROVAL FOR A CHANGE IN A QUALITY CONTROL RELEASE SPECIFICATION FOR A COMPONENT OF THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK.
P050018|S001|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCUPLT SCORING BALLOON CATHETER|NWX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2007|03/07/2007|||APPR|APPROVAL FOR MINOR CHANGES TO THE STRAIN RELIEF AND CATHETER SHAFT.
P960030|S014|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|ISOFLEX LEAD FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2007|03/08/2007|||OK30|MODIFY THE CRIMPING PROCESS FOR THE CONNECTOR RING ON ISOFLEX LEADS.
P910077|S072|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/2007|03/09/2007|||APPR|APPROVAL FOR LABELING CHANGES TO THE LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482 WHICH IS USED WITH THE PRIZM, VITALITY, CONTAK AND RENEWAL FAMILIES OF DEVICES.  SPECIFICALLY, THE LABELING CHANGES INCLUDE THE INTRODUCTION OF ERRATA SHEETS TO ADDRESS THE FOLLOWING ISSUES: 1) YELLOW ALERT NOTIFICATION; 2) HEART RATE DISPLAY; AND 3) WEIGHT ALERT.
P040014|S006|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|IBI THERAPY CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2007|03/16/2007|||APPR|APPROVAL FOR A NEW RF GENERATOR, WHICH INCLUDES SOFTWARE AND HARDWARE MODIFICATIONS TO THE PREVIOUSLY APPROVED RF GENERATOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY ABLATION CATHETER AND IBI 1500T9 RT ABLATION GENERATOR. THE THERAPY ABLATION CATHETER IS INDICATED FOR MAPPING AND FOR USE WITH THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.  THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ST. JUDE MEDICAL TEMPERATURE CONTROLLED ABLATION CATHETERS FOR CREATING ENDOCARDIAL LESIONS TO TREAT CARDIAC ARRHYTHMIAS (I.E. SUPRAVENTRICULAR TACHYCARDIAS, AND ATRIAL FLUTTER).  THE GENERATOR IS INTERNALLY LIMITED TO 50 WATTS WHEN USED WITH THE THERAPY ABLATION CATHETERS.
P040042|S008|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 ABLATION CATHETER & IBI-1500T6 CARDIAC ABLATION GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2007|03/16/2007|||APPR|APPROVAL FOR A NEW RF GENERATOR, WHICH INCLUDES SOFTWARE AND HARDWARE MODIFICATIONS TO THE PREVIOUSLY APPROVED RF GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY DUAL 8 ABLATION CATHETER AND IBI 1500T9 RF ABLATION GENERATOR. THE THERAPY DUAL 8 ABLATION CATHETER IS INTENDED FOR USE WITH THE IBI 1500T9 RADIOFREQUENCY (RF) ABLATION GENERATOR AT A MAXIMUM OF 100 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.  THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ST. JUDE MEDICAL TEMPERATURE CONTROLLED ABLATION CATHETERS FOR CREATING ENDOCARDIAL LESIONS TO TREAT CARDIAC ARRHYTHMIAS (I.E. SUPRAVENTRICULAR TACHYCARDIAS, AND ATRIAL FLUTTER).  THE GENERATOR IS LIMITED TO 100 WATTS WHEN USED WITH THE THERAPY DUAL 8 ABLATION CATHETERS.
P010031|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO MODEL C154DWK|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2007|03/26/2007|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE 9-PIN FILTERED FEEDTHROUGH (FFT) OF THE MEDTRONIC CONCERTO MODEL C154DWK AND VIRTUOSO MODELS D154AWG/D154VWC DEVICES.
P980016|S095|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VITRTUOSO MODELS D154AWG/D154VWC|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2007|03/26/2007|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE 9-PIN FILTERED FEEDTHROUGH (FFT) OF THE MEDTRONIC CONCERTO MODEL C154DWK AND VIRTUOSO MODELS D154AWG/D154VWC DEVICES.
P960040|S143|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, PRIZM II CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS  (CRT-D)|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2007|09/19/2007|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER FOR INTEGRATED CIRCUIT WAFER GOLD BUMPING SERVICE FOR THE PRIZM AND PRIZM II CRT-D DEVICES.
P030025|S044|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/13/2007|05/15/2009|||APPR|APPROVAL TO UPDATE THE INFORMATION IN THE INSTRUCTIONS FOR USE RELATED TO MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY.
P040016|S022|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/13/2007|05/15/2009|||APPR|APPROVAL TO UPDATE THE INFORMATION IN THE INSTRUCTIONS FOR USE RELATED TO MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY.
P020009|S036|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/13/2007|05/15/2009|||APPR|APPROVAL TO UPDATE THE INFORMATION IN THE INSTRUCTIONS FOR USE RELATED TO MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY.
P030017|S019|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/15/2007|03/02/2007|||APPR|APPROVAL FOR UPDATES TO THE ?PHYSICIAN LEAD MANUAL? (FOR LINEAR LEADS AND EXTENSIONS) LABELING TO HELP MINIMIZE THE OCCURRENCE OF STYLET PENETRATION.
P880031|S014|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON D|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/15/2007|08/22/2008|||APPR|APPROVAL TO MOVE THE MANUFACTURE OF VITRAX FROM THE ALLERGAN FACILITY IN WESTPORT, IRELAND TO THE AMO UPPSALA FACILITY IN SWEDEN, FOR A 0.4 ML FILL VOLUME IN ADDITION TO THE CURRENTLY APPROVED 0.65 ML FILL VOLUME, AND RE-BRAND THE DISPERSIVE VITRAX PRODUCT MANUFACTURED IN UPPSALA, SWEDEN AS HEALON D (DISPERSIVE).
P030002|S009|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|EYEONICS CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)|NAA|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2007|06/29/2007|||APPR|APPROVAL FOR RECOMMENDATION TO USE THE STAAR MSI-PF INJECTOR AND MTC-60C CARTRIDGE SYSTEM FOR INJECTING THE CRYSTALENS MODELS AT-45 & AT-45SE) TO BE ADDED TO THE PHYSICIAN LABELING.
P010012|S148|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 RF|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2007|03/16/2007|||OK30|UPDATE TO THE TEST SOFTWARE PERFORMED DURING THE E2 AND FINAL PACK TESTING.
P060001|S003|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/16/2007|08/02/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P940015|S011|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC HYLAN G-F 20|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/2007|06/09/2008|||APPR|APPROVAL FOR THE REPLACEMENT OF THE DILUTION STATEMENT FROM THE ?PRECAUTION? SECTION AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P990009|S019|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/20/2007|03/27/2007|||APPR|APPROVAL FOR A 10 ML FLOSEAL HEMOSTATIC MATRIX KIT.
P980040|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2007|03/22/2007|||OK30|ELIMINATION OF THE RELATIVE HUMIDITY (RH) SPECIFICATION IN THE GENERATION AREA IN THE MANUFACTURING FACILITY IN ANASCO, PUERTO RICO.
P990080|S019|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO TECNIS ACRYLIC LENS, MODEL ZA9003|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2007|03/20/2007|||OK30|ELIMINATION OF THE RELATIVE HUMIDITY SPECIFICATIONS IN THE GENERATION AREA IN THE ANASCO, PUERTO RICO FACILITY.
P960028|S017|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO SOFT ACRYLIC MULTIFOCAL IOLS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2007|03/21/2007|||OK30|ELIMINATION OF THE RELATIVE HUMIDITY SPECIFICATIONS IN THE GENERATION AREA IN THE ANASCO, PUERTO RICO FACILITY.
P980040|S012|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice||N|02/20/2007|03/20/2007|||OK30|REDUCTION OF CYCLE TIME ON LATHES USED IN THE MANUFACTURING FACILITY IN ANASCO, PUERTO RICO.
P990080|S020|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO TECNIS ACRYLIC LENS, MODEL ZA9003|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2007|03/20/2007|||OK30|REDUCTION OF CYCLE TIME ON LATHES USED IN THE MANUFACTURING FACILITY IN ANASCO, PUERTO RICO.
P960028|S018|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO SOFT ACRYLIC MULTIFOCAL IOLS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2007|03/20/2007|||OK30|REDUCTION OF CYCLE TIME ON LATHES USED IN THE MANUFACTURING FACILITY IN ANASCO, PUERTO RICO.
P970008|S031|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2007|03/19/2007|||OK30|CHANGE THE RECTAL THERMOSENSING UNIT (RTU) PLUS TEMPERATURE SENSOR CHANNEL WIDTH AND WELD THE T-WELD CORNERS WITH A GRADUAL RADIUS TURN.
P010013|S018|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2007|03/29/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORPORATION, MARLBOROUGH, MASSACHUSETTS.  THE MANUFACTURING STEPS TO BE PERFORMED AT MARLBOROUGH, MASSACHUSETTS WILL BE THE FINAL TEST, LABELING, PACKAGING AND INSPECTION/RELEASE OPERATIONS ASSOCIATED WITH THE RADIO FREQUENCY (RF) CONTROLLER.
P020018|S023|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2007|05/09/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WILLIAM COOK EUROPE, BJAEVERSKOV, DENMARK.
P030047|S002|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE AND PRECISE RX NITINOL STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2007|03/23/2007|||OK30|MODIFY THE ACCEPTANCE CRITERION FOR A PRODUCTION INSPECTION FOR THE PRECISE AND PRECISE RX NITINOL STENT SYSTEM.
P050007|S005|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2007|03/23/2007|||OK30|CHANGE IN A MANUAL TO A SEMI-AUTOMATED PROCESS FOR THE STARCLOSE CLIP APPLIER VERSION 2.13.
P910023|S131|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|HOUSECALL PLUS SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2007|04/17/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM, MERLIN.NET V2.0, WHICH WILL ALLOW THE PHYSICIAN TO VIEW CURRENTLY AVAILABLE WEB PORTAL.  IN ADDITION, THE RECEIVER SOFTWARE HAS BEEN MODIFIED TO IMPROVE THE COMMUNICATION EFFICIENCY.
P960013|S027|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL LEAD FAMILY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2007|03/23/2007|||OK30|ALTERNATE SUPPLIER OF THE FRONT SEAL COMPONENT.
P950022|S035|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA LEAD FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2007|03/23/2007|||OK30|ALTERNATE SUPPLIER OF THE FRONT SEAL COMPONENT.
P990013|S006|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2007|03/22/2007|||OK30|THE QUALIFICATION AND ADDITION OF A SECOND LARSEN COLLET BLOCKER AND PITCH DISPENSER.
P990013|S007|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2007|03/21/2007|||OK30|ADDING THE CARON HUMIDITY CHAMBER, MODEL 6030 TO THE MANUFACTURING PROCESS OF THE COLLAMER LENS FOR STORING WORK-IN-PROGRESS LENSES AND BUTTONS BETWEEN PREPARATION AND DRILLING.
P990013|S008|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2007|03/22/2007|||OK30|ADDITION OF THE OPTOFORM LATHE TO THE MANUFACTURING FACILITY OF STAAR IN MONROVIA, CALIFORNIA.
P910077|S073|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR SOFTWARE, VERSION 1.3 (MODEL 6481)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2007|05/01/2007|||APPR|APPROVAL FOR: 1) A CHANGE TO THE TIME BASE OF THE INDUCTIVE COMMUNICATOR CLOCK AND 2) IMPROVEMENTS TO TELEPHONE DETECTION/DISABLING OF THE CALL-WAITING FEATURE AND IMPROVEMENT OF TELEPHONE DIAL-TONE DETECTION.
P020022|S006|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2007|12/14/2007|||APPR|APPROVAL FOR THE ADDITION OF THE VERSANT 440 MOLECULAR SYSTEM (SYSTEM 400).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERSANT HCV RNA AND IS INDICATED FOR: THE VERSANT HCV RNA 3.0 ASSAY (BDNA) IS A SIGNAL AMPLIFICATION NUCLEIC ACID PROBE ASSAY FOR THE DIRECT QUANTITATION OF HUMAN HEPATITIS C VIRAL RNA (HCV RNA) IN THE SERUM OR PLASMA OF HCV INFECTED INDIVIDUALS USING THE SYSTEM 340 BDNA ANALYZER OR THE VERSANT 440 MOLECULAR SYSTEM.  SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE BEEN VALIDATED FOR QUANTITATION IN THE ASSAY.  THE VERSANT HCV RNA 3.0 ASSAY (BDNA) IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTI-VIRAL THERAPY.  THE ASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND IS USEFUL IN PREDICTING NON-SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY.  THE RESULTS FROM THE VERSANT HCV RNA 3.0 ASSAY (BDNA) MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.  ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED ONLY FOR INDIVIDUALS TREATED WITH INTERFERON ALFA-2B PLUS RIBAVIRIN.  NO INFORMATION IS AVAILABLE ON THE ASSAY?S PREDICTIVE VALUES WHEN OTHER THERAPIES ARE USED.
P990066|S028|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/21/2007|04/13/2007|||APPR|APPROVAL FOR 1) A NEW COMPUTER; 2) MODIFICATION OF THE SOFTWARE; 3) ADDITION OF A THIRD PARTY SOFTWARE PROGRAM; 4) CHANGES IN THE PROPRIETARY SOFTWARE; AND 5) REPLACEMENT OF THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WITH A SMALLER TYPE.
P860004|S089|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/2007|11/05/2008|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 8835 PERSONAL THERAPY MANAGER (MYPTM) AND THE MODEL 37092 DETACHABLE ANTENNA.
P900009|S025|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)|LPQ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2007|06/11/2007|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF THE EXTERNAL PLASTIC HOUSING FOR THE MAIN OPERATING UNIT.  THIS INCLUDES THE TOP HOUSING, THE BOTTOM HOUSING, THE PUSH BUTTON AND THE LENS.
P990013|S009|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|SURGICAL COLLAMER UV-ABSORBING POSTERIOR IOL|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2007|05/01/2007|||APPR|APPROVAL FOR IMPLEMENTATION OF THE IN-PROCESS BURST TESTING OF POUCHES USED ON THE COLLAMER IOLS.
P990013|S010|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2007|03/23/2007|||OK30|REPLACEMENT OF HEXANE WITH WATER FOR CLEANING OF THE ARBORS AND THE ADDITION OF A VISUAL INSPECTION OF THE WAX QUANTITY TO THE ARBOR IN THE MANUFACTURING PROCESS.
P020026|S033|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2007|03/28/2007|||OK30|ELIMINATION OF THE STENT FLIP VERIFICATION STEP DURING THE TOPCOAT MANUFACTURING PROCESS FOR THE DEVICE.
P910077|S074|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2007|06/15/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 6482 RT COMMUNICATOR FOR USE ON THE LATITUDE PATIENT MANAGEMENT SYSTEM.  THE MODIFICATIONS INCLUDE A SOFTWARE UPGRADE (VERSION 1.7.0) AND CHANGES TO THE HARDWARE TO INCREASE RF TRANSMIT POWER.
P000039|S021|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/2007|08/02/2007|||APPR|APPROVAL FOR THE ADDITION OF THE 30 MM DEVICE SIZE TO THE CRIBRIFORM  PRODUCT LINE.
P020056|S002|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/23/2007|05/02/2007|||APPR|APPROVAL FOR THE DIPHENYL PATCH DESIGN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NATRELLE SILICONE-FILLED BREAST IMPLANTS AND IS INDICATED FOR BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD AND FOR BREAST RECONSTRUCTION FOR WOMEN OF ANY AGE.  BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY.  BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY.  BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
P990074|S018|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANT|FWM|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/23/2007|05/17/2007|||APPR|APPROVAL FOR A TRADE NAME CHANGE FROM INAMED SALINE-FILLED BREAST IMPLANTS TO NATRELLE SALINE-FILLED BREAST IMPLANTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NATRELLE SALINE-FILLED BREAST IMPLANTS AND IS INDICATED FOR 1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER; AND 2) BREAST RECONSTRUCTION.
P850035|S031|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF PLUS 60/W AND SPF-PLUS 60/M|LOE|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2007|06/21/2007|||APPR|APPROVAL FOR DEVICE MODIFICATIONS TO INCORPORATE IDENTICAL BATTERY CHEMISTRY AND IMPLANT TESTER CONFIGURATION AS APPROVED IN THE SPF-XL IIB DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPF-PLUS 60/W AND SPF-PLUS 60/M AND IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS.
P880091|S020|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|03/26/2007|||OK30|IMPLEMENTATION OF AN IN-PROCESS BURST TESTING OF POUCHES USED FOR PACKAGING OF THE SILICONE IOLS.
P990013|S011|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|03/28/2007|||OK30|CHANGES TO THE CLEANING PROCEDURES FOR MANUFACTURING EQUIPMENT.
P960013|S028|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|SJM ACTIVE & PASSIVE LEADS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|11/19/2009|||APPR|APPROVAL FOR A MINOR PROCESS CHANGE TO AN SJM VENDOR IN THE MANUFACTURE OF SJM ACTIVE AND PASSIVE LEADS.
P960030|S015|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|SJM ACTIVE & PASSIVE LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|11/19/2009|||APPR|APPROVAL FOR A MINOR PROCESS CHANGE TO AN SJM VENDOR IN THE MANUFACTURE OF SJM ACTIVE AND PASSIVE LEADS.
P030036|S003|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE 3830|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|10/21/2008|||APPR|APPROVAL FOR A CHANGE TO THE 1 CC SYRINGE USED TO MANUALLY MEASURE APPLICATION WITH A MANUALLY OPERATED AUTOMATED DISPENSER AND TO MODIFY THE DIMENSIONS OF THE FILLING TUBE TO PREVENT OVER-FILL OF THE PRECISELY MEASURED STEROID SOLUTION WITHIN THE FILLING TUBE.
P990013|S012|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER 1-PC AND 3-PC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|03/22/2007|||OK30|ADDITION OF THE KAYE VALIDATOR VALIDATION SYSTEM TO THE VALIDATION PROCESS.
P950022|S036|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|03/28/2007|||OK30|ADDITION OF AN ALTERNATE WELDING PROCESS.
P990001|S028|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/26/2007|07/10/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE VITATRON FAMILY APPLICATION SOFTWARE MODELS THAT SUPPORT THE DIVA, DEMA AND SELECTION AFM 902 DEVICES (VSC02 VERSION 9.1 SR1), C-SERIES DEVICES A1 MODELS (VSF04 VERSION 1.3), C-SERIES DEVICES A3 MODELS (VSF12 VERSION 1.2, AND T-SERIES DEVICES (VSF08 VERSION 1.6).  THE MODIFICATIONS WILL UPDATE THE EMI BEHAVIOR OF YOUR DEVICE, CORRECT THE ISSUE OF DA+ INHIBITION OF PACING BELOW THE PROGRAMMED THRESHOLD, IDENTIFY TO THE USER INACCURATE COULOMB COUNTS, ALLOW THE APPLICATION SUITE TO BE SPLIT INTO SEVERAL APPLICATION PACKAGES, AND MINOR SOFTWARE ENHANCEMENTS.
P950022|S037|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|03/23/2007|||OK30|ALTERNATE VENDOR OF THE MOLDED CONNECTOR BOOT FOR THE MANUFACTURER OF RIATA ST LEADS.
P020056|S003|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANT|FTR|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/26/2007|05/17/2007|||APPR|APPROVAL FOR A TRADE NAME CHANGE FROM INAMED SILICONE-FILLED BREAST IMPLANTS TO NATRELLE SILICONE-FILLED BREAST IMPLANTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NATRELLE SILICONE-FILLED BREAST IMPLANTS AND IS INDICATED FOR BREAST AUGMENTATION FOR WOMEN AT LEAST 22 YEARS OLD AND FOR BREAST RECONSTRUCTION FOR WOMEN OF ANY AGE.  BREAST AUGMENTATION INCLUDES PRIMARY BREAST AUGMENTATION TO INCREASE THE BREAST SIZE, AS WELL AS REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST AUGMENTATION SURGERY.  BREAST RECONSTRUCTION INCLUDES PRIMARY RECONSTRUCTION TO REPLACE BREAST TISSUE THAT HAS BEEN REMOVED DUE TO CANCER OR TRAUMA OR THAT HAS FAILED TO DEVELOP PROPERLY DUE TO A SEVERE BREAST ABNORMALITY.  BREAST RECONSTRUCTION ALSO INCLUDES REVISION SURGERY TO CORRECT OR IMPROVE THE RESULT OF A PRIMARY BREAST RECONSTRUCTION SURGERY.
P030005|S042|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR FAMILY OF PULSE GENERATORS (PGS)|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2007|03/29/2007|||OK30|THREE EFFICIENCY CHANGES TO THE MANUFACTURING PROCESS.
P930038|S049|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2007|03/29/2007|||OK30|CHANGE TO THE VACUUM DRYING PROCESS AND A CHANGE TO THE ENVIRONMENTAL CONDITIONS OF THE MANUFACTURING FACILITY.
P020040|S006|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 8|POB 58165|TEL-AVIV||61581||STENT, CORONARY|NIRFLEX PREMOUNTED CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2007|03/29/2007|||OK30|USE OF A NEW STENT CLEANING RACK DURING THE FINAL CLEANING PROCESS IN THE MANUFACTURE OF THE DEVICE.
P040002|S009|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2007|03/29/2007|||OK30|CHANGE TO THE SUREPASS CONTRALATERAL LIMB SHEATH/GUIDEWIRE ASSEMBLY OF THE VISIFLEX DELIVERY SYSTEM.
P890003|S116|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS, CARELINK MONITOR, CARDIO SIGHT READER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2007|05/04/2007|||APPR|APPROVAL FOR UPDATES TO THE CARELINK V1.1 DEVICE DATA MANAGEMENT APPLICATION TO (1) PROVIDE SUPPORT FOR CONCERTO WITH ATRIAL THERAPIES; (2) ALLOW TRANSMISSION OF AN ?ALERT? SIGNAL FOR AT/AF BURDEN AND FAST V RESPONSE OBSERVATIONS IF THERE IS AN ASSOCIATED ALERT; (3) OUTPUT THE TYPE OF EPISODE LOG FOR INVALID EPISODES SO CARELINK CAN PROPERLY DISPLAY INVALID EPISODES AS ARRHYTHMIA EPISODES OR VENTRICULAR SENSING EPISODES; AND (4) CORRECT A PROBLEM WHERE THE CARDIAC COMPASS ?VENTRICULAR RATE DURING AT/AF? GRAPH DOES NOT ALWAYS PRINT THE MEAN VENTRICULAR RATE.
P010031|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2007|05/04/2007|||APPR|APPROVAL FOR UPDATES TO THE CARELINK V1.1 DEVICE DATA MANAGEMENT APPLICATION TO (1) PROVIDE SUPPORT FOR CONCERTO WITH ATRIAL THERAPIES; (2) ALLOW TRANSMISSION OF AN ?ALERT? SIGNAL FOR AT/AF BURDEN AND FAST V RESPONSE OBSERVATIONS IF THERE IS AN ASSOCIATED ALERT; (3) OUTPUT THE TYPE OF EPISODE LOG FOR INVALID EPISODES SO CARELINK CAN PROPERLY DISPLAY INVALID EPISODES AS ARRHYTHMIA EPISODES OR VENTRICULAR SENSING EPISODES; AND (4) CORRECT A PROBLEM WHERE THE CARDIAC COMPASS ?VENTRICULAR RATE DURING AT/AF? GRAPH DOES NOT ALWAYS PRINT THE MEAN VENTRICULAR RATE.
P980016|S096|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO MODELS D154AWG / D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2007|05/04/2007|||APPR|APPROVAL FOR UPDATES TO THE CARELINK V1.1 DEVICE DATA MANAGEMENT APPLICATION TO (1) PROVIDE SUPPORT FOR CONCERTO WITH ATRIAL THERAPIES; (2) ALLOW TRANSMISSION OF AN ?ALERT? SIGNAL FOR AT/AF BURDEN AND FAST V RESPONSE OBSERVATIONS IF THERE IS AN ASSOCIATED ALERT; (3) OUTPUT THE TYPE OF EPISODE LOG FOR INVALID EPISODES SO CARELINK CAN PROPERLY DISPLAY INVALID EPISODES AS ARRHYTHMIA EPISODES OR VENTRICULAR SENSING EPISODES; AND (4) CORRECT A PROBLEM WHERE THE CARDIAC COMPASS ?VENTRICULAR RATE DURING AT/AF? GRAPH DOES NOT ALWAYS PRINT THE MEAN VENTRICULAR RATE.
P990075|S017|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2007|03/19/2007|||OK30|CHANGE IN A SUPPLIER USED FOR SOME COMPONENTS USED IN THE MANUFACTURING OF THE DEVICES.
P880091|S021|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL SILICONE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2007|03/29/2007|||OK30|ADDING THE FUJI IMPULSE POUCH SEALERS TO THE SILICONE MANUFACTURING PROCESS.
P050012|S008|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM STS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2007|03/15/2007|||OK30|MOVE OF THE FINAL KITTING AND SHIPPING PROCESSES FOR THE STS SYSTEM TO A SECOND FACILITY.
P040034|S008|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2007|03/29/2007|||OK30|CHANGES FOR THE PURPOSE OF QUALIFYING IN-HOUSE LAL (LIMULUS AMEBOCYTE LYSATE) TESTING.
P030017|S020|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS)SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2007|05/29/2007|||APPR|APPROVAL FOR THE ST LINEAR LEAD (SHORT TIP LINEAR LEAD).
P990052|S016|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)|MPV|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2007|03/30/2007|||OK30|UPDATE TO THE SHELF-LIFE INFORMATION OF THE SILICONE RUBBERS AND EPOXIES AND CHANGE TO THE COATING OF THE AUDIO PROCESSOR (AP) MAGNETS FROM ALUMINUM CHROMATE IV TO ALUMINUM PHOSPHATE.
P990081|S005|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|VENTANNA PATHWAY HER-2 (CLONE CB11)|MVC|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/02/2007|04/11/2007|||APPR|APPROVAL FOR CHANGE IN THE LABELING TO INCLUDE THE PATHWAY HER-2 4 IN 1 CONTROL SLIDES.
P040050|S001|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2007|07/27/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE FROM MINNEAPOLIS, MINNESOTA TO MINNETONKA, MINNESOTA.
P010014|S015|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2007|07/05/2007|||APPR|APPROVAL FOR CHANGES TO THE PROCESS SPECIFICATIONS FOR THE AQUEOUS CLEANING PROCESS USED DURING THE MANUFACTURE OF THE COMPONENTS OF BIOMET?S OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM.
P020009|S037|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 MONORAIL (MR) & OVER-THE-WIRE (OTW) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2007|04/04/2007|||OK30|REMOVAL OF A REDUNDANT INSPECTION STEP IN THE MANUFACTURE OF THE DEVICE.
P030025|S045|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2007|04/04/2007|||OK30|REMOVAL OF A REDUNDANT INSPECTION STEP IN THE MANUFACTURE OF THE DEVICE.
P040037|S004|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE S4URFACE|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/2007|07/31/2007|||APPR|APPROVAL OR THE ADDITION OF A HEPARIN COATING ON THE GORE VIABAHN ENDOPROSTHESIS, REFERRED TO AS THE HEPARIN BIOACTIVE SURFACE.
P980037|S022|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2007|05/10/2007|||APPR|APPROVAL FOR THE SPIROFLEX THROMBECTOMY SET.
P960030|S016|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|ISOFLEX S LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2007|05/09/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE LEAD INSULATION WALL THICKNESS AND LENGTH, AS WELL AS A CHANGE TO THE OUTER COIL EXIT ANGLE.
P000058|S022|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/ LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/2007|12/20/2007|||APPR|APPROVAL FOR ADDING XS AND XXS INFUSE BONE GRAFT KITS TO THE PRODUCT LINEUP.
P040038|S010|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2007|03/30/2007|||OK30|ADDING SEVERAL INSPECTION STEPS DURING THE MANUFACTURE OF THE DEVICE AND THE REVISION OF AN INSPECTION LIMIT.
P000010|S009|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST VERSION 2.0|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|08/30/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN SOMERVILLE, NEW JERSEY FOR OLIGONUCLEOTIDE AND ENZYME MANUFACTURING.
P000029|S021|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/05/2007|07/21/2008|||APPR|APPROVAL FOR A CHANGE IN THE SOURCE OF DEXTRANOMER MATERIAL USED TO MANUFACTURE DEFLUX INJECTABLE GEL FROM DX-10 TO DX.
P050025|S002|BOSTON SCIENTIFIC|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CAROTID|ENDOTEX NEXSTENT CAROTID STENT AND MONORAIL|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|03/07/2007|04/10/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000012|S013|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST VERSION 2.0|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2007|08/30/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN SOMERVILLE, NEW JERSEY FOR OLIGONUCLEOTIDE AND ENZYME MANUFACTURING.
P030026|S013|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2007|04/06/2007|||OK30|ADDITION OF A RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS.
P020004|S019|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2007|07/25/2007|||APPR|APPROVAL FOR THE ADDITION OF AN OPTIONAL QUALITY CONTROL INSPECTION IN THE GRAFT ATTACH PROCESS FOR THE DEVICE.
P040043|S013|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2007|07/25/2007|||APPR|APPROVAL FOR THE ADDITION OF AN OPTIONAL QUALITY CONTROL INSPECTION IN THE GRAFT ATTACH PROCESS FOR THE DEVICE.
P040006|S004|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|IN MOTION ARTIFICIAL DISC|MJO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/2007|09/05/2007|||APPR|APPROVAL FOR: 1) ADDITIONAL ENDPLATES WITH LARGER FOOTPRINT, LATERAL PLACEMENT OF FIXATION TEETH, AND 1 MM OFFSET ARTICULATING SURFACE; 2) ADDITIONAL CORES WITH MODIFIED OUTER RIM; 3) MODIFIED SURGICAL INSTRUMENTS TO ACCOMMODATE MODIFIED DEVICE COMPONENTS; AND 4) MODIFIED SURGICAL TECHNIQUE.
P020047|S009|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION RX CORONARY STENT & MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2007|04/04/2007|||OK30|REPLACEMENT OF THE EXISTING BONDING EQUIPMENT WITH A NEW HEAT BONDER.
P980022|S019|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2007|07/11/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO, BAJA CALIFORNIA, MEXICO.
P000044|S015|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2007|03/27/2007|||OK30|CHANGE IN THE HUMAN DEFIBRINATED ANTI-HBS NEGATIVE PLASMA SUPPLIER AND UPDATING THE RAW MATERIAL DOCUMENTATION.
P010025|S010|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2007|06/01/2007|||APPR|APPROVAL FOR A CHANGE TO THE BLEMISHED PIXEL SPECIFICATIONS.
P040042|S009|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE TX CARDIAC ABLATION CATHETER AND INTERFACE CABLES|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/2007|08/21/2007|||APPR|APPROVAL FOR THE SAFIRE TX CARDIAC ABLATION CATHETER MODEL 1642 AND THE MODELS 1740-SW AND 1779-SE INTERFACE CABLES.
P980050|S026|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2007|07/17/2007|||APPR|APPROVAL FOR AN INCREASE IN THE CAPACITY OF THE BOARD BURN-IN CHAMBER.
P010031|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS FAMILIES OF CRT-ICDS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2007|07/17/2007|||APPR|APPROVAL FOR AN INCREASE IN THE CAPACITY OF THE BOARD BURN-IN CHAMBER.
P980016|S097|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2007|07/17/2007|||APPR|APPROVAL FOR AN INCREASE IN THE CAPACITY OF THE BOARD BURN-IN CHAMBER.
P040033|S004|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|03/12/2007|10/01/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P960040|S144|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY FAMILY|LWP|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2007|03/29/2007|||APPR|APPROVAL FOR THE FOLLOWING CHANGES FOR THE VITALITY AND CONTAK RENEWAL FAMILIES OF DEFIBRILLATORS: 1) REQUIRE THE REED SWITCH COMPONENT SUPPLIER TO EXPOSE 100% OF THE COMPONENTS TO A HIGH MAGNETIC FIELD CONDITION OF MINIMUM OF 30MT, 10 CYCLES WITH 1 SECOND DURATION PRIOR TO SHIPPING TO GUIDANT. 2) APPLY AN ENHANCED QUALITY TEST OF 30MT THROUGH 30 CYCLES AND VERIFY THE REED SWITCH IS OPEN AFTER REMOVING THE DEVICE FROM THE MAGNETIC FIELD, TO ALL DEVICES CURRENTLY HELD UNDER A STOP ACTION NOTICE (SAN).
P010012|S149|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY|LWP|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2007|03/29/2007|||APPR|APPROVAL FOR THE FOLLOWING CHANGES FOR THE VITALITY AND CONTAK RENEWAL FAMILIES OF DEFIBRILLATORS: 1) REQUIRE THE REED SWITCH COMPONENT SUPPLIER TO EXPOSE 100% OF THE COMPONENTS TO A HIGH MAGNETIC FIELD CONDITION OF MINIMUM OF 30MT, 10 CYCLES WITH 1 SECOND DURATION PRIOR TO SHIPPING TO GUIDANT. 2) APPLY AN ENHANCED QUALITY TEST OF 30MT THROUGH 30 CYCLES AND VERIFY THE REED SWITCH IS OPEN AFTER REMOVING THE DEVICE FROM THE MAGNETIC FIELD, TO ALL DEVICES CURRENTLY HELD UNDER A STOP ACTION NOTICE (SAN).
P820003|S079|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS FAMILIES OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P020025|S019|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CATHETERS|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2007|06/13/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA.
P920047|S037|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2007|06/13/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA.
P980003|S018|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2007|06/13/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA.
P850051|S065|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VARIOUS FAMILIES OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P030029|S001|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2007|08/02/2007|||APPR|APPROVAL FOR AN ADDITIONAL COMPONENT SUPPLIER.
P030005|S043|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2007|04/13/2007|||OK30|TWO NEW SUPPLIERS OF RESISTORS USED IN THE CONTAK RENEWAL TR FAMILY OF DEVICES.
P890003|S117|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P900061|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P930022|S005|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P970012|S027|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P980016|S098|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P980035|S072|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P980050|S027|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF, GEMM III AT FAMILY OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P990001|S029|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P010015|S027|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC/ INSYNC III, CRT IPG'S|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P010031|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO INSYNC FAMILIES OF CRT-ICD'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2007|05/03/2007|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
P970003|S077|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2007|12/14/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYBERONICS, HOUSTON, TEXAS.
P040002|S010|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2007|04/04/2007|||OK30|CHANGE TO THE FRONT SHEATH SUBASSEMBLY OF THE VISIFLEX DELIVERY SYSTEM.
P040002|S011|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2007|04/13/2007|||OK30|ALTERNATE SUPPLIER OF EPTFE GRAFT USED IN THE POWERLINK SYSTEM STENT GRAF SUBASSEMBLY.
P040042|S010|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|IBI THERAPY DUAL 8 ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2007|04/13/2007|||OK30|CHANGE TO ADD A NEW SUPPLIER FOR THE ISOLATION TRANSFORMER FOR THE 1500T6 (USA) RT GENERATOR.
P030017|S021|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2007|04/13/2007|||OK30|CHANGE IN THE ADHESION PROCESS FOR THE ARTISAN 2 X 8 SURGICAL LEAD ELECTRODES OF THE DEVICE.
P030025|S046|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2007|04/04/2007|||OK30|MODIFICATION TO THE PROXIMAL WELD IN-PROCESS ACCEPTANCE CRITERIA IN THE MANUFACTURE OF THE DEVICE.
P020009|S038|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2007|04/04/2007|||OK30|MODIFICATION TO THE PROXIMAL WELD IN-PROCESS ACCEPTANCE CRITERIA IN THE MANUFACTURE OF THE DEVICE.
P040016|S023|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2007|04/04/2007|||OK30|MODIFICATION TO THE PROXIMAL WELD IN-PROCESS ACCEPTANCE CRITERIA IN THE MANUFACTURE OF THE DEVICE.
P010033|S012|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON TB GOLD|NCD|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2007|11/28/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CELESTIS LIMITED, VICTORIA, AUSTRALIA FOR THE BULK FORMULATION OF PEPTIDES.
P030007|S003|CARESTREAM HEALTH,INC.|150 Verona Street||ROCHESTER|NY|14608||Analyzer,medical image|KODAK MAMMOGRAPHY CAD ENGINE|MYN|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2007|03/23/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT EASTMAN KODAK COMPANY, ROCHESTER, NEW YORK.  THIS IS ASOFTWARE MANUFACTURING LOCATION CHANGE THAT CONSISTS OF A SERVER MOVE FROM SAN JOSE, CALIFORNIA TO ROCHESTER, NEW YORK.
P990004|S011|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE, SURGIFLO HEMOSTATIC MATRIX|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2007|04/13/2007|||APPR|APPROVAL FOR A LABELING CHANGE ALLOWING WORDING THAT WILL RECOMMEND THE DRAWING OF 2 TO 5 ML SALINE OR THROMBIN FOR USE WITH SURGIFLO HEMOSTATIC MATRIX.
P960013|S029|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL FAMILY OF LEADS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2007|08/06/2007|||APPR|APPROVAL FOR AN ALTERNATE CIRCUMFERENTIAL WELD TO THE CURRENT MULTIPLE SPOT WELDS TO CONNECT THE INNER COIL TO THE HELIX SHAFT.
P960004|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FINELINE II/THINLINE II STEROX LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2007|04/18/2007|||APPR|APPROVAL FOR ELECTRODE TIP COMPONENT MODIFICATIONS AND MEDICAL ADHESIVE REPLACEMENT.
P010059|S003|MORCHER GMBH|KAPUZINERWEG 12||STUTTGART, WURTTEMBERG-BADEN||D-703|7037|Ring, endocapsular|MORCHER CAPSULAR TENSION RINGS|MRJ|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2007|05/22/2009|||APPR|APPROVAL FOR THE ADDITION OF CAPSULAR TENSION RINGS (CTRS) MODELS1G, 2S, 6D, 6E, AND 10C AND CHANGE IN PACKAGING TO INCORPORATE THE MORCHER INJECTOR PRELOADED WITH CTR MODELS 14, 14A, AND 14C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MORCHER CAPSULAR TENSION RINGS (MODELS 1G, 2S, 6D, 6E, AND 10C) AND EYEJET CTR AND IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK ORPARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENSIMPLANTATION. CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARYZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA ORVITRECTOMY), CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI¿S SYNDROME.
P050053|S001|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/19/2007|03/06/2008|||APPR|APPROVAL FOR THE ADDITION OF THE XS AND XXS INFUSE BONE GRAFT KITS TO THE APPROVED DENTAL BONE GRAFTING MATERIAL.
P000044|S016|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK  AND CALIBRATOR & CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2007|04/16/2007|||OK30|ADDITION OF A RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS.
P010032|S020|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS, GENESIS RC, GENESIS XP AND THE EON NEUROSTIMULATION SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/21/2007|06/11/2007|||APPR|APPROVAL FOR THE USE OF THE TRIPOLE 8, TRIPOLE 8C, TRIPOLE 16C, AND EXCLAIM 8 LAMITRODE SERIES LEADS (MODELS 3208, 3210, 3214,  3224) WITH THE GENESIS, GENESIS RC, GENESIS XP, AND EON NEUROSTIMULATION SYSTEMS, WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P010029|S006|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA 1% SODIUM HYALURONATE|MOZ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/22/2007|07/11/2007|||APPR|APPROVAL FOR A SYRINGE TIP CAP MATERIAL CHANGE FROM NATURAL RUBBER TO A SYNTHETIC RUBBER FORMULATION.
P010020|S004|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2007|04/17/2007|||OK30|ADDITIONAL IN-PROCESS CYTOTOXICITY TESTING SITE FOR THE DEVICE.
P920023|S020|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME URETHRAL STENT|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2007|04/17/2007|||OK30|ADDITIONAL IN-PROCESS CYTOTOXICITY TESTING SITE FOR THE DEVICE.
P000053|S008|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2007|04/17/2007|||OK30|ADDITIONAL IN-PROCESS CYTOTOXICITY TESTING SITE FOR THE DEVICE.
P020004|S020|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2007|04/20/2007|||OK30|CHANGE TO MODIFY THE DESTRUCTIVE TESTING PROCEDURE FOR THE NITINOL WIRE USED FOR THE MANUFACTURE OF THE EXCLUDER AAA ENDOPROSTHESIS.
P000029|S022|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2007|06/06/2007|||APPR|APPROVAL FOR A CHANGE IN THE TEST METHOD FOR THE DETERMINATION OF HYALURONIC ACID CONTENT IN THE FINISHED PRODUCT.
P000029|S023|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2007|06/06/2007|||APPR|APPROVAL TO RE-QUALIFY THE STERILIZATION PROCESS FOR ANALYZING BIOLOGICAL INDICATORS IN THE FINISHED PRODUCT.
P000029|S024|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2007|04/19/2007|||OK30|CHANGE IN THE BIOBURDEN TESTING OF THE DEFLUX NEEDLES.
P000029|S025|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2007|04/20/2007|||OK30|CHANGE INVOLVING BIOBURDEN TESTING OF ALL WATER SAMPLES.
P840001|S096|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATOR SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2007|06/11/2007|||APPR|APPROVAL FOR THE MODEL 39565 SPECIFY 5-6-5 LEAD KIT.
P050012|S009|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM STS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2007|04/10/2007|||OK30|AUTOMATION FOR CONFORMAL COATING REMOVAL IN THE MANUFACTURE OF THE DEVICE.
P960013|S030|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL FAMILY OF LEADS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2007|08/21/2007|||APPR|APPROVAL FOR AN ALTERNATIVE WELD PATTERN.
P000029|S026|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2007|04/20/2007|||OK30|CHANGE THE AUTOCLAVING PROCEDURE FOR EQUIPMENT AND UTENSILS.
P000029|S027|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2007|07/10/2007|||OK30|CHANGE IN SHELF LIFE FOR A FILTER USED IN THE MANUFACTURING PROCESS OF THE DEVICE.
P000029|S028|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2007|04/20/2007|||OK30|CHANGE THE MAINTENANCE OF THE WATER SYSTEM USED FOR WATER FOR INJECTION (WFI).
P000029|S029|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2007|04/20/2007|||OK30|CHANGES IN THE CALIBRATION TEST RANGES AND LIMITS FOR PROBES IN AUTOCLAVES.
P030053|S004|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|03/27/2007|04/27/2007|||APPR|APPROVAL TO REVISE THE POST-APPROVAL STUDY TO ALLOW FOR THE VOLUNTARY RATHER THAN MANDATORY PARTICIPATION OF ALL PATIENTS, IRRESPECTIVE OF THE TYPE OF IMPLANT (I.E., MEMORYGEL IMPLANT OR SALINE IMPLANTS) THEY RECEIVE.
P970003|S078|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/2007|04/12/2007|||APPR|APPROVAL FOR THE ADDITION OF DETAILED INFORMATION CONTAINED IN THE APPROVED TEST TO THE FIGURES PROVIDED IN THE LABELING TO PROVIDE FURTHER CLARIFICATION CONCERNING THE PROPER LEAD IMPLANT TECHNIQUE.  ADDITIONALLY, FURTHER DETAILS WERE PROVIDED TO STRESS THE IMPORTANCE OF PROPER STRAIN RELIEF PLACEMENT (I.E. PROPER TIE-DOWN LOCATION AND STRAIN RELIEF BEND).
P990001|S030|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON IPGS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/27/2007|04/25/2007|||APPR|APPROVAL FOR THE L289-010A/B INTEGRATED CIRCUIT CONTROLLER FOR THE VITATRON C- AND T- PACEMAKER MODELS C60A3, C20A3, T60A1, AND T20A1.
P900060|S038|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2007|04/26/2007|||OK30|ADDITIONAL STERILIZER FOR STERILIZING CARBOMEDICS CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES.
P960028|S019|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL IOLS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2007|04/26/2007|||OK30|REDUCE OPERATOR HANDLING OF LENSES BY ELIMINATING THE 100% VISUAL INSPECTION PROCESSING STEP CONDUCTED AT POST-TUMBLING FOR ALL OF THE SOFT ACRYLIC IOLS.
P980040|S013|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR ACRYLIC INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2007|04/26/2007|||OK30|REDUCE OPERATOR HANDLING OF LENSES BY ELIMINATING THE 100% VISUAL INSPECTION PROCESSING STEP CONDUCTED AT POST-TUMBLING FOR ALL OF THE SOFT ACRYLIC IOLS.
P990080|S021|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2007|04/26/2007|||OK30|REDUCE OPERATOR HANDLING OF LENSES BY ELIMINATING THE 100% VISUAL INSPECTION PROCESSING STEP CONDUCTED AT POST-TUMBLING FOR ALL OF THE SOFT ACRYLIC IOLS.
P010021|S010|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2007|04/16/2007|||OK30|ADDITION OF A RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS.
P960028|S020|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL IOLS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2007|04/26/2007|||OK30|CHANGE IN THE 100% IN-PROCESS DIMENSIONAL INSPECTION STEP FOR ALL SOFT ACRYLIC INTRAOCULAR LENSES.
P980040|S014|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR ACRYLIC INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2007|04/26/2007|||OK30|CHANGE IN THE 100% IN-PROCESS DIMENSIONAL INSPECTION STEP FOR ALL SOFT ACRYLIC INTRAOCULAR LENSES.
P990080|S022|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2007|04/26/2007|||OK30|CHANGE IN THE 100% IN-PROCESS DIMENSIONAL INSPECTION STEP FOR ALL SOFT ACRYLIC INTRAOCULAR LENSES.
P040011|S001|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry antibody assay, c-kit|DAKO C-KIT PHARMDX|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2007|04/23/2007|||OK30|CHANGE TO PERFORM TARGET RETRIEVAL AT AN INCREASED TEMPERATURE AND SHORTER INCUBATION TIME UNDER PRESSURE.
P000025|S023|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBO 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/29/2007|09/24/2007|||APPR|APPROVAL FOR THE OPUS-1 EXTERNAL SPEECH PROCESSOR AND THE MAESTRO 2.0.1, WHICH ARE NEW COMPONENTS OF THE APPROVED COMBI 40+ COCHLEAR IMPLANT SYSTEM AND ARE INDICATED FOR USE ON PATIENTS WHO HAVE BEEN IMPLANTED WITH PULSARCI100 AND/OR SONATATI100 COCHLEAR IMPLANTS.  THE SOFTWARE, MAESTRO 2.0.1, IS INTENDED FOR PROGRAMMING THE OPUS-1 SPEECH PROCESSOR, AND IMPLEMENTS TWO NEW SPEECH CODING STRATEGY FEATURES, HIGH DEFINITION CIS (HDCIS) AND FINE STRUCTURE PROCESSING (FSP).
P060019|S001|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2007|07/13/2007|||APPR|APPROVAL FOR A CHANGE FROM LOT RELEASE TO PARAMETRIC RELEASE.
P030031|S005|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/2007|01/04/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE NAVISTAR THERMOCOOL CATHETER DESIGN SO THAT IT IS COMPATIBLE WITH THE STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM.
P000037|S012|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2007|04/11/2007|||APPR|APPROVAL FOR WARNING AGAINST RESTERILIZATION.
P040036|S003|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL LINE EXTENSION|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/2007|01/04/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE NAVISTAR THERMOCOOL CATHETER DESIGN SO THAT IT IS COMPATIBLE WITH THE STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM.
P970053|S011|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2007|09/30/2013|13M-1362|10/30/2013|APPR|APPROVAL  FOR THE NIDEK EC-5000 EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR TOPOGRAPHY-ASSISTED LASER- ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENT USING THE FINAL FIT¿ CUSTOM ABLATION TREATMENT PLANNING SOFTWARE FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS FROM -1.0 TO -4.0 D OF SPHERE WITH ASTIGMATIC REFRACTIVE ERRORS FROM >-0.5 TO -2.0 D AT THE SPECTACLE PLANE; IN PATIENTS 21 YEARS OF AGE OR OLDER; AND, IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN ±0.5 D.
P040012|S026|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK & RX ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2007|05/02/2007|||OK30|CHANGE TO THE STENT DEPLOYMENT FORCE LOT RELEASE TEST METHOD.
P040037|S005|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2007|05/02/2007|||OK30|RETROFIT EXISTING MANUFACTURING EQUIPMENT WITH COMPUTER-CONTROLLED HARDWARE.
P040027|S004|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2007|05/02/2007|||OK30|RETROFIT EXISTING MANUFACTURING EQUIPMENT WITH COMPUTER-CONTROLLED HARDWARE.
P040033|S005|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2007|06/27/2007|||APPR|APPROVAL FOR THE ADDITION AND MODIFICATION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND REVISIONS TO THE SURGICAL TECHNIQUE.
P940040|S007|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST|MWA|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2007|08/30/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN SOMERVILLE, NEW JERSEY FOR OLIGONUCLEOTIDE AND ENZYME MANUFACTURING.
P010038|S014|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECONDLOOK|MYN|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2007|07/27/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PROVEN PROCESS MEDICAL DEVICES, MANSFIELD, MASSACHUSETTS.
P980016|S099|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ENTRUST 35J ICD (D154ATG, D15DRG. D154VRC) MEDTRONIC VIRTUOSO ICD (D154AWG, D154VWC)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2007|08/07/2007|||APPR|APPROVAL FOR A CHANGE TO THE CAPACITOR PERIMETER INSULATION TAPE.
P010031|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO (C154DWK)|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2007|08/07/2007|||APPR|APPROVAL FOR A CHANGE TO THE CAPACITOR PERIMETER INSULATION TAPE.
P010019|S006|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/2007|07/26/2007|||APPR|APPROVAL FOR REVISED LABELING FOR NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR.
P050018|S002|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT SCORING BALLOON CATHETER|NWX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2007|07/12/2007|||APPR|APPROVAL FOR A MINOR CHANGES TO THE STRAIN RELIEF AND CATHETER SHAFT.
P030017|S022|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS)SYSTEM INTRODUCER|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/2007|07/18/2007|||APPR|APPROVAL FOR AN OPTIONAL SURGICAL TOOL CALLED THE INTRODUCER.
P020004|S021|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2007|05/04/2007|||OK30|CHANGE OF THE GRAFT ATTACH PROCEDURE FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P020026|S034|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2007|05/04/2007|||OK30|CHANGE TO THE BALLOON WALL IRREGULARITY INSPECTION CRITERIA.
P790002|S025|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET BHS- MINI|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|01/17/2008|||APPR|APPROVAL FOR DESIGN MODIFICATIONS RELATED TO TWO NEW COILS, A NEW BATTERY TYPE, A NEW COIL APPLICATION METHOD, AND A REDESIGNED CONTROL BOX.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIOMET BHS-MINI AND IS INDICATED FOR THE TREATMENT OF FRACTURE NON-UNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDOARTHROSIS IN THE APPENDICULAR SYSTEM.
P030002|S010|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS? MODELS AT-50SE AND AT-52SE ACCOMMODATING INTRAOCULAR LENSES (IOLS)|NAA|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|07/26/2007|||APPR|APPROVAL FOR THE MODELS AT-50SE AND AT-52SE ACCOMMODATING IOLS USED WITH THE STAAR MSI-PF/TF INJECTOR AND MTC-60C CARTRIDGE.
P930038|S050|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2007|05/04/2007|||OK30|CHANGES TO THE SCHEDULING OF THE LOT RELEASE DEPLOYMENT TEST FOR ANGIO-SEAL VASCULAR CLOSURE DEVICE.
P040003|S004|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000, VERSION 4.22|NRZ|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2007|08/02/2007|||APPR|APPROVAL FOR SEVERAL HARDWARE ENHANCEMENTS AND SOFTWARE ERROR CORRECTIONS.
P030017|S023|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2007|06/29/2007|||APPR|APPROVAL FOR THE PRECISION OMG (OBSERVATIONAL MECHANICAL GATEWAY) CONNECTOR-M.
P000058|S023|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2007|10/05/2007|||APPR|APPROVAL FOR THE ALTERNATE 2X MANUFACTURING PROCESS OF RHBMP-2.
P000054|S011|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2007|10/05/2007|||APPR|APPROVAL FOR THE ALTERNATE 2X MANUFACTURING PROCESS OF RHBMP-2.
P050053|S002|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2007|10/05/2007|||APPR|APPROVAL FOR THE ALTERNATE 2X MANUFACTURING PROCESS OF RHBMP-2.
P030054|S050|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CURRENT ICD'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2007|09/11/2007|||APPR|APPROVAL FOR ADDING THE WIRELESS COMMUNICATION BETWEEN THE PROGRAMMER AND THE IMPLANTABLE DEVICES.
P910023|S132|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PROMOTE MODELS 3207-36 AND 3207-30|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2007|09/11/2007|||APPR|APPROVAL FOR ADDING THE WIRELESS COMMUNICATION BETWEEN THE PROGRAMMER AND THE IMPLANTABLE DEVICES.
P030054|S051|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CURRENT ICD; EPIC HF/ ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|05/07/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING:  ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS.   THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
P030035|S028|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|05/07/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING:  ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS.   THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
P830045|S107|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON/PHOENIX FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|05/07/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING:  ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS.   THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
P880006|S050|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILT OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|05/07/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING:  ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS.   THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
P880086|S142|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|05/07/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING:  ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS.   THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
P910023|S133|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PROMOTE CRT-D; CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|05/07/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING:  ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS.   THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
P970013|S017|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2007|05/07/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING:  ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS.   THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
P850048|S021|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA WHO STANDARDIZATION|MTF|IM|Panel Track|Change Design/Components/Specifications/Material|N|08/21/2007|05/09/2008|08M-0425|07/25/2008|APPR|APPROVAL FOR THE ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS.  THE ACCESS HYBRITECH PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS.    THE DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER.  PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER.  THE DEVICE IS FURTHER INDICATED FOR THE SERIAL MEASUREMENT OF PSA TO AID IN THE PROGNOSIS AND MANAGEMENT OF PATIENTS WITH PROSTATE CANCER.
P000029|S030|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2007|05/01/2007|||OK30|CHANGE IN THE METHOD OF MANAGING MATERIALS IN THE Q-MED AB WAREHOUSE.
P000040|S010|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HTA SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2007|08/08/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT NEXCORE TECHNOLOGY, INC., WALDWICK, NEW JERSEY TO MANUFACTURE THE FOLLOWING COMPONENTS: HTA SYSTEM CONSOLE, REUSABLE HEATER CANISTER, AND SCOPE ADAPTER.
P930014|S020|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF SINGLE-PIECE INTRAOCULAR LENS (IOL)|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2007|09/06/2007|||APPR|APPROVAL TO ADD A VISION ENHANCEMENT SYSTEM TO THE AUTOMILL IN THE MANUFACTURING OF THE INTRAOCULAR LENSES.
P040020|S004|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC INTRAOCULAR LENS (IOL)|MFK|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2007|09/06/2007|||APPR|APPROVAL TO ADD A VISION ENHANCEMENT SYSTEM TO THE AUTOMILL IN THE MANUFACTURING OF THE INTRAOCULAR LENSES.
P040033|S006|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/2007|11/13/2008|||APPR|APPROVAL FOR A LINE EXTENSION TO THE BHR SYSTEM (IE., MODULAR VERSION OF THE BHR CUP FOR USES WITH OPTIONAL SCREWS AND APEX/SCREW HOLD COVERS) AND A SITE CHANGE (SMITH & NEPHEW, INC., MEMPHIS, TENNESSEE).
P950037|S051|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS AND AXIOS FAMILY OF PULSE GENERATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2007|08/31/2007|||APPR|APPROVAL FOR CHANGES TO THE INTEGRATED CIRCUIT PACKAGING, CIRCUIT BOARD SUBSTRATE, HEADER ASSEMBLY, AND THE TEL 3000 INTERFACE IN THE PHILOS AND AXIOS FAMILY OF PULSE GENERATORS.
P050025|S003|BOSTON SCIENTIFIC|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CAROTID|NEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2007|05/10/2007|||OK30|ADDITION OF AN INSPECTION PROCEDURE AND A NEW VISUAL STANDARD THAT WILL BE IMPLEMENTED AS PART OF ROUTINE RECEIVING AND INSPECTION FOR A SUBASSEMBLY USED WITH THE NEXSTENT CAROTID STENT SYSTEM.
P990080|S023|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON MODELS 911A AND 913A, TECNIS MODELS Z9000 AND Z9001|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2007|05/08/2007|||OK30|ADDITION OF A SECOND ETO STERILIZER (GEE 6913 AR-1) USED IN THE STERILIZATION OF IOLS MANUFACTURED AT THE AMO GRONINGEN, NETHERLANDS FACILITY.
P960034|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS|HQL|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2007|05/08/2007|||OK30|ADDITION OF A SECOND ETO STERILIZER (GEE 6913 AR-1) USED IN THE STERILIZATION OF IOLS MANUFACTURED AT THE AMO GRONINGEN, NETHERLANDS FACILITY.
P880070|S012|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2007|05/08/2007|||OK30|ADDITION OF A SECOND ETO STERILIZER (GEE 6913 AR-1) USED IN THE STERILIZATION OF IOLS MANUFACTURED AT THE AMO GRONINGEN, NETHERLANDS FACILITY.
P040001|S005|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS DECOMPRESSION SYSTEM|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/30/2007|11/20/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P030054|S052|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + FAMILY OF CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2007|05/07/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
P030035|S029|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2007|05/07/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
P830045|S108|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON/PHOENIX FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2007|05/07/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
P880006|S051|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2007|05/07/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
P880086|S143|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2007|05/07/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
P910023|S134|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICD'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2007|05/07/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
P970013|S018|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/13/2007|05/07/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
P970003|S079|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/2007|06/29/2007|||APPR|APPROVAL FOR SHELF LIFE EXTENSION FROM ONE TO TWO YEARS.
P970003|S080|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2007|05/10/2007|||OK30|MODIFY THE CURRENT MANUFACTURING PROCESS OF THE NCP PROGRAMMING WANDS, MODEL 201 BY ADDING AN AUTOMATED VERSION OF THE FINAL ELECTRICAL TEST PROCESS.
P790007|S018|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MO VALVED CONDUITS, MODEL 150|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2007|05/10/2007|||OK30|CHANGE TO THE SUPPLIER OF THE POLYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.
P050012|S010|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM STS SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/16/2007|05/25/2007|||APPR|APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO PROVIDE ADDITIONAL SUPPLEMENTARY INFORMATION TO USERS ON GLUCOSE TRENDS AND PATTERNS DOWNLOADED TO THE PROGRAM.  THE SOFTWARE PROGRAM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCON DM2 AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS SYSTEM INTO A PERSONAL COMPUTER (PC).
P870072|S036|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/16/2007|07/27/2007|||APPR|APPROVAL FOR A CHANGE IN THE DESIGN OF THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE SYSTEM?S PNEUMATIC LINE.
P030047|S003|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM|NIM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2007|07/12/2007|||APPR|APPROVAL FOR THE CORDIS PRECISE PRO RX NITINOL STENT SYSTEM.
P020055|S001|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2007|05/16/2007|||OK30|CHANGE OF SYSTEM OPERATING SOFTWARE FROM DOS TO WINDOWS FOR THE DROP VOLUME TESTER COMPUTER WORKSTATION HARDWARE.
P910023|S135|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2007|05/10/2007|||OK30|USE OF AN ALTERNATE VENDOR FOR THE ICD/CRT-D SEPTUM MATERIAL.
P030054|S053|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2007|05/10/2007|||OK30|USE OF AN ALTERNATE VENDOR FOR THE ICD/CRT-D SEPTUM MATERIAL.
P890003|S118|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2007|06/14/2007|||APPR|APPROVAL FOR A CHANGE OF THREE COMPONENTS USED IN THE MANUFACTURING O 2490C MEDTRONIC CARELINK MONITOR.  THE COMPONENTS BEING CHANGED ARE THE VOLTAGE CONTROLLED OSCILLATOR (VCXO) AND TWO CAPACITORS.  THOSE ARE: 1) THE VCXO PROVIDES AN OUTPUT FREQUENCY IN RESPONSE TO A GIVEN VOLTAGE INPUT.  FOR THE 2490C MEDTRONIC CARELINK MONITOR THE VCXO SUPPORTS THE TELEMETRY FEATURE OF THE MONITOR.  THE SAME MANUFACTURER PROVIDES BOTH THE ORIGINAL PART (PART NUMBER CSX750VCB20.000MUT) AND THE NEW PART (PART NUMBER CSX750VJB20.000MUT).  2) THERE ARE TWO CAPACITORS BEING CHANGED.  THE CAPACITOR AT LOCATION C230 IS CHANGING FROM 3300 PF TO 6800 PF.  THE CAPACITOR AT LOCATION C277 IS CHANGING FROM 470 PF TO 6800 PF.  BOTH THE CURRENT CAPACITORS AND THE NEW CAPACITORS ARE PROVIDED BY THE SAME MANUFACTURER.
P980016|S100|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2007|06/14/2007|||APPR|APPROVAL FOR A CHANGE OF THREE COMPONENTS USED IN THE MANUFACTURING O 2490C MEDTRONIC CARELINK MONITOR.  THE COMPONENTS BEING CHANGED ARE THE VOLTAGE CONTROLLED OSCILLATOR (VCXO) AND TWO CAPACITORS.  THOSE ARE: 1) THE VCXO PROVIDES AN OUTPUT FREQUENCY IN RESPONSE TO A GIVEN VOLTAGE INPUT.  FOR THE 2490C MEDTRONIC CARELINK MONITOR THE VCXO SUPPORTS THE TELEMETRY FEATURE OF THE MONITOR.  THE SAME MANUFACTURER PROVIDES BOTH THE ORIGINAL PART (PART NUMBER CSX750VCB20.000MUT) AND THE NEW PART (PART NUMBER CSX750VJB20.000MUT).  2) THERE ARE TWO CAPACITORS BEING CHANGED.  THE CAPACITOR AT LOCATION C230 IS CHANGING FROM 3300 PF TO 6800 PF.  THE CAPACITOR AT LOCATION C277 IS CHANGING FROM 470 PF TO 6800 PF.  BOTH THE CURRENT CAPACITORS AND THE NEW CAPACITORS ARE PROVIDED BY THE SAME MANUFACTURER.
P010031|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS FAMILIES OF CRT-ICD'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2007|06/14/2007|||APPR|APPROVAL FOR A CHANGE OF THREE COMPONENTS USED IN THE MANUFACTURING O 2490C MEDTRONIC CARELINK MONITOR.  THE COMPONENTS BEING CHANGED ARE THE VOLTAGE CONTROLLED OSCILLATOR (VCXO) AND TWO CAPACITORS.  THOSE ARE: 1) THE VCXO PROVIDES AN OUTPUT FREQUENCY IN RESPONSE TO A GIVEN VOLTAGE INPUT.  FOR THE 2490C MEDTRONIC CARELINK MONITOR THE VCXO SUPPORTS THE TELEMETRY FEATURE OF THE MONITOR.  THE SAME MANUFACTURER PROVIDES BOTH THE ORIGINAL PART (PART NUMBER CSX750VCB20.000MUT) AND THE NEW PART (PART NUMBER CSX750VJB20.000MUT).  2) THERE ARE TWO CAPACITORS BEING CHANGED.  THE CAPACITOR AT LOCATION C230 IS CHANGING FROM 3300 PF TO 6800 PF.  THE CAPACITOR AT LOCATION C277 IS CHANGING FROM 470 PF TO 6800 PF.  BOTH THE CURRENT CAPACITORS AND THE NEW CAPACITORS ARE PROVIDED BY THE SAME MANUFACTURER.
P910023|S136|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ICD'S|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2007|02/25/2008|||APPR|APPROVAL FOR AN UPDATE TO THE SENSOR FLEX DRAWING REQUIREMENT.
P030054|S054|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT'S|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2007|02/25/2008|||APPR|APPROVAL FOR AN UPDATE TO THE SENSOR FLEX DRAWING REQUIREMENT.
P910023|S137|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2007|05/16/2007|||OK30|USE OF SECOND SOURCE VENDORS FOR SEVERAL DISCRETE COMPONENTS ON THE DEVICE HYBRID.
P030054|S055|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2007|05/16/2007|||OK30|USE OF SECOND SOURCE VENDORS FOR SEVERAL DISCRETE COMPONENTS ON THE DEVICE HYBRID.
P880086|S144|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2007|05/16/2007|||OK30|USE OF SECOND SOURCE VENDORS FOR SEVERAL DISCRETE COMPONENTS ON THE DEVICE HYBRID.
P030035|S030|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2007|05/16/2007|||OK30|USE OF SECOND SOURCE VENDORS FOR SEVERAL DISCRETE COMPONENTS ON THE DEVICE HYBRID.
P880091|S022|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE THREE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2007|05/16/2007|||OK30|IMPLEMENTATION OF THE ROTLEX IOLA PLUS OPTICAL TEST SYSTEMS AS AN ADDITIONAL MEASURING SYSTEM FOR THE DIOPTERIC POWER MEASUREMENT OF 3-PIECE SILICONE INTRAOCULAR LENSES (IOL) HAS BEEN REVIEWED.
P040047|S002|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|BIOFORM MEDICAL COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2007|05/17/2007|||OK30|NEW SUPPLIER OF GLYCERIN, A RAW MATERIAL USED IN THE MANUFACTURE OF COAPTITE.
P050037|S001|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2007|05/02/2007|||OK30|CHANGE IN THE SUPPLIER OF A RAW MATERIAL.
P050052|S002|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2007|05/02/2007|||OK30|CHANGE IN THE SUPPLIER OF A RAW MATERIAL.
P960058|S057|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2007|07/27/2007|||APPR|APPROVAL FOR THE REVISION OF THE MANUFACTURING SPECIFICATION SOP (MS0037) TO INCLUDE AN ADDITIONAL VACUUM/BACKFILL CYCLE.
P860019|S220|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|BOSTON SCIENTIFIC MAVERICK 2 MONORAIL PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2007|05/10/2007|||OK30|ALTERNATE MANUFACTURING FIXTURE FOR LASER PRINTING INFORMATION ON THE DEVICE MANIFOLD.
P980049|S026|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO DR 6550 & OVATIO VR 6250 DEVICES|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2007|05/18/2007|||OK30|CHANGE IN THE FLUX USED FOR SOLDER REWORK.
P040002|S012|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2007|05/18/2007|||OK30|CHANGE OF VENDORS FOR THE OBTURATOR COMPONENT OF THE INNER CORE SUBASSEMBLY OF THE 19FR STRAIGHT VISIFLEX DELIVERY SYSTEM.
P050006|S003|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2007|05/18/2007|||OK30|MODIFICATION OF THE DESTRUCTIVE TESTING PROCEDURE FOR THE NITINOL WIRE USED IN THE MANUFACTURE OF THE DEVICE.
P970018|S012|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/19/2007|05/09/2007|||APPR|APPROVAL FOR LABELING CHANGES FOR EXTENSION OF THE ANTIMICROBIAL EFFECTIVENESS OF THE SUREPATH PRESERVATIVE FLUID TO 14 DAYS FOR E. COLI, P. AERUGINOSA, S. AUREUS, C. ALBICANS, AND A. NIGER AND 28 DAYS FOR M. TUBERCULOSIS.
P030025|S047|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/19/2007|10/16/2007|||APPR|APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE.
P010003|S010|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/20/2007|06/07/2007|||APPR|APPROVAL FOR THE ADDITION OF A NON-STERILE, REUSABLE SYRINGE DELIVERY DEVICE.
P900023|S048|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|AB5000 CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/23/2007|12/21/2007|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE A STATEMENT REGARDING ADDITIONAL IN VITRO RELIABILITY TESTING OF THE PUMP.
P040045|S001|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL|LPM|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/23/2007|08/14/2007|||APPR|APPROVAL FOR AN ADDITIONAL INDICATION FOR THERAPEUTIC USE FOR THE VISTAKON (SENOFILCON A) CONTACT LENS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACUVUE OASYS BRAND CONTACT LENSES WITH HYDRACLEAR PLUS (SENOFILCON A) AND IS ADDITIONALLY INDICATED FOR THERAPEUTIC USE AS A BANDAGE LENS FOR THE FOLLOWING ACUTE AND CHRONIC CONDITIONS:1) FOR CORNEAL PROTECTION IN LID AND CORNEAL ABNORMALITIES SUCH AS ENTROPION, TRICHIASIS, TARSAL SCARS AND RECURRENT CORNEAL EROSION.  IN ADDITION IT IS INDICATED FOR PROTECTION WHERE SUTURES OR OCULAR STRUCTURE MALFORMATION, DEGENERATION OR PARALYSIS MAY RESULT IN THE NEED TO PROTECT THE CORNEA FROM EXPOSURE OR REPEATED IRRITATION.  2)  FOR CORNEAL PAIN RELIEF IN CONDITIONS SUCH AS BULLOUS KERATOPATHY, EPITHELIAL EROSION AND ABRASION, FILAMENTARY KERATITIS, AND POST-KERATOPLASTY. 3) FOR USE AS A BARRIER DURING THE HEALING PROCESS OF EPITHELIAL DEFECTS SUCH AS CHRONIC EPITHELIAL DEFECTS, CORNEAL ULCER, NEUROTROPHIC AND NEUROPARALYTIC KERATITIS, AND CHEMICAL BURNS. 4)   FOR POST SURGICAL CONDITIONS WHERE BANDAGE LENS USE IS INDICATED SUCH AS POST REFRACTIVE SURGERY, LAMELLAR GRAFTS, CORNEAL FLAPS, AND ADDITIONAL OCULAR SURGICAL CONDITIONS. 5) FOR STRUCTURAL STABILITY AND PROTECTION IN PIGGY BACK LENS FITTING WHERE THE CORNEA AND ASSOCIATED SURFACES ARE TOO IRREGULAR TO ALLOW FOR CORNEAL RIGID GAS PERMEABLE (RGP) LENSES TO BE FIT.  IN ADDITION THE USE OF THE LENS CAN PREVENT IRRITATION AND ABRASIONS IN CONDITIONS WHERE THERE ARE ELEVATION DIFFERENCES IN THE HOST/GRAPH JUNCTION OR SCAR TISSUE.  LENSES PRESCRIBED FOR THERAPEUTIC USE MAY BE WORN FOR DAILY OR EXTENDED WEARING PERIODS.
P030054|S056|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-D'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2007|05/09/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.
P030035|S031|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-P'S|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2007|05/09/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.
P830045|S109|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PARAGON/PHOENIX FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2007|05/09/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.
P880006|S052|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2007|05/09/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.
P880086|S145|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2007|05/09/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.
P910023|S138|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICD'S|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2007|05/09/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.
P970013|S019|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2007|05/09/2007|||APPR|APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.
P880086|S146|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2007|05/09/2007|||APPR|APPROVAL FOR THE ZEPHYR XL SR MODEL 5626 PACEMAKER WHICH UTILIZES THE XL BATTERY MODEL 9438 WHICH IS CURRENTLY APPROVED FOR USE WITH THE MARKETED ZEPHYR XL DR 5826 PACEMAKER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZEPHYR XL SR MODEL 5626 AND IS INDICATED FOR SINGLE CHAMBER RATE ADAPTIVE PACING.
P980016|S101|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO,MARQUIS,MAXIMO,INTRINSIC & ENTRUST ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2007|06/25/2007|||APPR|APPROVAL FOR THE L325-03 AND L325-04 INTEGRATED CIRCUIT (IC) TO MINIMIZE THE POTENTIAL FOR A GATE-OXIDE BREAKDOWN WITHIN THE L325-01, L325-02, AND L281-04 ICS.
P010031|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO CRT-ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2007|06/25/2007|||APPR|APPROVAL FOR THE L325-03 AND L325-04 INTEGRATED CIRCUIT (IC) TO MINIMIZE THE POTENTIAL FOR A GATE-OXIDE BREAKDOWN WITHIN THE L325-01, L325-02, AND L281-04 ICS.
P030006|S013|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/23/2007|11/20/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P030002|S011|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)|NAA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2007|05/25/2007|||OK30|CHANGE IN THE TUMBLING AND PRE-CLEANING PROCESS FOR THE DEVICE.
P910023|S139|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|EPIC/EPIC+/ATLAS/ATLAS+/CONVERT/CONVERT+ ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2007|05/23/2007|||OK30|CHANGES TO THE EPIC ICD AND CRT-D SELF-TEST MANUFACTURING SOFTWARE TEST METHOD.
P030054|S057|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC+HF/ATLAS+HF/EPIC HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2007|05/23/2007|||OK30|CHANGES TO THE EPIC ICD AND CRT-D SELF-TEST MANUFACTURING SOFTWARE TEST METHOD.
P030017|S024|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/26/2007|05/14/2007|||APPR|APPROVAL FOR AN ADDENDUM TO THE BIONIC NAVIGATOR SOFTWARE GUIDE.
P960016|S018|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|SAFIRE CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/26/2007|06/08/2007|||APPR|APPROVAL FOR A LABELING MODIFICATION THAT ALLOWS THE BOSTON MAESTRO 3000 RT GENERATOR TO BE USED WITH THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER AND EXTENSION CABLES.
N18286|S016|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM (ABSORBABLE GELATIN) STERILE AND POWDER|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2007|05/21/2007|||OK30|NEW STERILIZATION EQUIPMENT WITH NEW STERILIZATION PATTERNS.
P030011|S002|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2007|05/23/2007|||OK30|USE OF A LARGER STERILIZATION CHAMBER TO STERILIZE THE DEVICE.
P050047|S001|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/27/2007|06/11/2007|||APPR|APPROVAL FOR LABELING MODIFICATIONS ADDING ADDITIONAL FOLLOW-UP DATA.
P970003|S081|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY PULSE GENERATORS|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/2007|05/14/2007|||APPR|APPROVAL TO ADD ADDITIONAL PRECAUTIONARY INFORMATION TO THE MODEL 300 LEAD PHYSICIAN?S MANUAL AS AN ERRATA SHEET AND TO REVISE THE MODEL 102, 102R, 302 AND 303 VNS THERAPY PHYSICIAN?S MANUAL MODULE ENTITLED ?INTRODUCTION TO THE VNS THERAPY (SYSTEM INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS).?
P980035|S073|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2007|05/13/2008|||APPR|APPROVAL FOR THE MEDTRONIC ADAPTA/VERSA/SENSIA IMPLANTABLE PACEMAKERS (A/V/S PACEMAKERS), MODEL SW003 APPLICATION SOFTWARE, AND MODEL 2490H MEDTRONIC CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE.
P890003|S119|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR MODEL 2490H|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2007|05/13/2008|||APPR|APPROVAL FOR THE MEDTRONIC ADAPTA/VERSA/SENSIA IMPLANTABLE PACEMAKERS (A/V/S PACEMAKERS), MODEL SW003 APPLICATION SOFTWARE, AND MODEL 2490H MEDTRONIC CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE.
P030022|S005|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2007|07/25/2008|||APPR|APPROVAL FOR A CHANGE IN THE CLEANING AND PASSIVATION MANUFACTURING EQUIPMENT.
P050038|S001|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2007|06/06/2007|||APPR|APPROVAL FOR THE REMOVAL OF THE UROLOGICAL PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT.
P910023|S140|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2007|06/01/2007|||OK30|ALTERNATE SUPPLIER OF RESISTOR CHIPS FOR USE IN THE EPIC AND ATLAS DEVICES.
P020018|S024|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT/ZENITH RENU AAA ANCILLARY GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2007|07/05/2007|||APPR|APPROVAL TO MARKET THE 36 MM DIAMETER ZENITH AAA ENDOVASCULAR GRAFT/ZENITH RENU AAA ANCILLARY GRAFT
P990013|S013|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/04/2007|09/26/2008|||APPR|APPROVAL FOR CHANGES TO THE LABELING.
P910031|S024|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2007|06/22/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, GERMANY GMBH, WIESBADEN, GERMANY.
P050007|S006|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2007|07/30/2007|||APPR|APPROVAL FOR DESIGN CHANGES TO THE PUSHER BODY FOR BOTH THE STARCLOSE? VASCULAR CLOSURE SYSTEM (VCS) AND THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM AD FOR THE ADDITION OF CHAMBERS ON THE INTERIOR OF THE STARCLOSE? SE VASCULAR CLOSURE SYSTEM TO IMPROVE THE RETRACTION OF THE THUMB ADVANCER.
P960058|S058|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/07/2007|07/02/2007|||APPR|APPROVAL FOR THREE ?VACUUM BAKE AIR FLOW ENHANCEMENTS? TO THE HIRES90K COCHLEAR IMPLANT, AS FOLLOWS: 1) THE BOTTOM COVER SHIELD INSIDE THE HIRES90K CASE WAS MODIFIED FROM HAVING A ?V?-SHAPED CHANNEL TO HAVING A LARGER ?U?-SHAPED CHANNEL.  2) HOLES WERE ADDED TO THE INSULATING KAPTON DISC.  3) SLOTS WERE IMPLEMENTED INSIDE THE FEEDTHROUGH CASE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR INDIVIDUALS AGED 12-MONTHS AND OLDER WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS TO RESTORE A LEVEL OF AUDITORY SENSATION VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.
P810031|S034|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON SODIUM HYALURONATE VISCOELASTIC PRODUCTS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|06/06/2007|||OK30|CHANGE IN THE PARTICLE FILTER USED IN THE MANUFACTURING OF HEALON OPHTHALMIC VISCOELASTIC PRODUCTS.
P960006|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX/FLEXTEND|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|06/06/2007|||OK30|CHANGE TO THE CURE TIME OF THE FLEXTEND DRUG COLLAR BOND.
P910023|S141|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|06/06/2007|||OK30|ENHANCEMENTS IN THE MANUFACTURE OF THE HIGH VOLTAGE CAPACITOR USED IN THE DEVICE.
P030054|S058|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR   (CRT-D)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|06/06/2007|||OK30|ENHANCEMENTS IN THE MANUFACTURE OF THE HIGH VOLTAGE CAPACITOR USED IN THE DEVICE.
P900056|S089|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|10/29/2008|||APPR|APPROVAL FOR 1) A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION, FREMONT, CALIFORNIA; AND 2) THE ADDITION OF A VENDOR FOR CONSOLE ACCESSORIES.
P940040|S008|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST|MWA|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|01/11/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., PLEASANTON, CALIFORNIA FOR BULK POSITIVE CONTROL STOCK MANUFACTURING.
P050038|S002|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|05/30/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE LOCATED AT SURGICAL TECHNOLOGIES, INC. (STI), ST. PAUL, MINNESOTA.
P970038|S009|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/2007|09/19/2007|||APPR|APPROVAL FOR THE USE OF THE ACCESS (HYBRITECH) FREE PSA REAGENTS ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM.
P850048|S022|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/2007|09/18/2007|||APPR|APPROVAL FOR THE USE OF THE ACCESS (HYBRITECH) PSA REAGENTS ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM.
P880081|S033|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|06/07/2007|||OK30|CHANGES IN THE EXTRACTION METHOD AND SAMPLING PLAN.
P960028|S021|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2007|06/07/2007|||OK30|CHANGES IN THE EXTRACTION METHOD AND SAMPLING PLAN.
P990080|S024|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2007|07/16/2007|||APPR|APPROVAL TO ADD AN ALTERNATE MANUFACTURING SITE, A.M.O. PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.
P040024|S008|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2007|06/07/2007|||OK30|CHANGES TO THE TEST METHOD FOR DETERMINING CONDUCTIVITY IN SODIUM CHLORIDE (NACL) SOLUTION.
P960013|S031|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL & RIATA FAMILY OF LEADS|NVZ|CV|30-Day Notice||N|05/09/2007|06/08/2007|||OK30|ALTERNATE SUPPLIER OF THE CONNECTOR RING COMPONENT.
P950022|S038|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|TENDRIL & RIATA FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2007|06/08/2007|||OK30|
P000029|S031|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2007|06/01/2007|||OK30|CHANGE OF AN INSTRUMENT USED TO TEST AN INCOMING RAW MATERIAL.
P970029|S011|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|TMR2000 HOLMIUM LASER SYSTEM|MNO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/2007|11/05/2007|||APPR|APPROVAL FOR PEARL 5.0 HANDPIECE.
P960013|S032|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL & RIATA FAMILY OF LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2007|06/08/2007|||OK30|ALTERNATE SUPPLIER OF THE INNER CRIMP SLEEVE COMPONENT.
P950022|S039|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|TENDRIL & RIATA FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2007|06/08/2007|||OK30|ALTERNATE SUPPLIER OF THE INNER CRIMP SLEEVE COMPONENT.
P980003|S019|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|Real-Time Process|Other Report|N|05/10/2007|07/24/2007|||APPR|APPROVAL FOR EXTENSION OF THE EXPIRATION DATE (SHELF-LIFE) FROM ONE-YEAR TO THREE-YEARS FOR THE CHILLI II CARDIAC ABLATION CATHETER.
P030024|S006|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2007|06/06/2007|||OK30|ADDITION OF A RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS.
P040043|S014|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2007|06/06/2007|||OK30|REMOVAL OF THE REDUNDANT 100% WATER ENTRY PRESSURE (WEP) IN-PROCESS TESTING FOR THE COMPONENT TUBES OF THE DEVICE.
P020004|S022|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2007|06/06/2007|||OK30|REMOVAL OF THE REDUNDANT 100% WATER ENTRY PRESSURE (WEP) IN-PROCESS TESTING FOR THE COMPONENT TUBES OF THE DEVICE.
P000014|S015|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2007|06/06/2007|||OK30|ADDITION OF A RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS.
P960013|S033|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL LEADS MODELS 1788 & 1782|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/2007|06/26/2007|||APPR|APPROVAL FOR RING ELECTRODE MODIFICATIONS TO TENDRIL 1788 AND 1782 LEADS, AND AN OUTER INSULATION TUBE DIAMETER CHANGE FOR TENDRIL 1782 LEADS.
P040016|S024|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2007|06/08/2007|||OK30|CHANGE FROM A MANUAL PACKAGING PROCESS TO A MACHINE-ASSISTED PROCESS.
P990052|S018|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM|MPV|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2007|06/13/2007|||OK30|CHANGE TO THE STERILIZATION PROCESS PARAMETERS FOR THE VIBRANT SOUNDBRIDGE VIBRATING OSSICULAR PROSTHESIS IMPLANT.
P970038|S010|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2007|06/13/2007|||OK30|CHANGE TO MODIFY THE PURIFICATION PROCESS FOR THE ANTIBODY USED IN THE MANUFACTURE OF THE ALKALINE PHOSPHATASE-ANTIBODY CONJUGATE.
P040043|S015|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2007|06/13/2007|||OK30|CHANGE TO STANDARDIZE THE CURRENT WIRE TESTING.
P900033|S016|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2007|06/13/2007|||OK30|EXTENDING THE SHIPPING TIME FOR THE DEVICE FROM 72 HOURS TO 120 HOURS.
P030053|S005|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/31/2007|03/05/2008|||APPR|APPROVAL FOR AN ALTERNATIVE SPRAY METHOD FOR MANUFACTURING THE SHELL COMPONENT OF THE MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS.
P890003|S120|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODEL 2090 BURBOT AND SPLAKE PROGRAMMERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2007|06/07/2007|||APPR|APPROVAL FOR AN ALTERNATE HARD DISK DRIVE (HDD) USED ON MEDTRONIC MODEL 2090 ?BURBOT? THAT ALSO INCLUDES A  MINOR DESIGN CHANGE AND AN ALTERNATE FLOPPY DISC DRIVE (FDD) USED ON BOTH MEDTRONIC MODEL 2090 ?SPLAKE? AND ?BURBOT? CARELINK PROGRAMMERS.
P970054|S004|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|IGG ENZYME IMMUNOASSAY|MYL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2007|06/08/2007|||OK30|CHANGE IN A QUALITY CONTROL TEST FOR THE IN-PROCESS DEVICE.
P970055|S004|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|IGM ENZYME IMMUNOASSAY|MYM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2007|06/08/2007|||OK30|CHANGE IN A QUALITY CONTROL TEST FOR THE IN-PROCESS DEVICE.
P040034|S009|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2007|06/11/2007|||APPR|APPROVAL FOR THE USE OF THE KENDALL MONOJECT 3 ML POLYPROPHYLENE SYRINGE IN PLACE OF THE TERUMO, MEDICAL 3 ML SYRINGE.
P040027|S005|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2007|06/14/2007|||OK30|CHANGE IN VENDOR FOR THE ACCESS SLEEVE COMPONENT OF THE GORE VIATORR TIPS ENDOPROSTHESIS DELIVERY SYSTEM.
P920015|S037|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT FIDELIS LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2007|07/03/2007|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO IMPROVE THE DF-1 LEG STRENGTH AND HANDLING CHARACTERISTICS OF SPRINT FIDELIS LEADS.
P000043|S017|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATRIX OFFICE THERMOTHERAPY SYSTEM (TMX-3000)|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2007|06/14/2007|||OK30|IMPLEMENT A REPLACEMENT COMPONENT USED ON THE TMX-3000 SYSTEM?S MICROWAVE MODULE PRINTED CIRCUIT BOARD.
P950032|S044|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2007|07/13/2007|||APPR|APPROVAL FOR A NEW CELL STRAIN, HEP 040, FOR INTRODUCTION INTO PRODUCTION OF APLIGRAF.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APLIGRAF AND IS INDICATED FOR THE TREATMENT OF PARTIAL AND FULL THICKNESS CHRONIC VENOUS ULCERS.
P880086|S147|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY,IDENTITY,VERITY,INTEGRITY,VICTORY,ZEPHYR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2007|06/15/2007|||OK30|MODIFICATIONS TO THE MANUFACTURING PROCESS OF DISPENSING EPOXY ON A COMPONENT LOCATED ON THE PACEMAKER HYBRID.
P030035|S032|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II CRT-P PACEMAKERS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2007|06/15/2007|||OK30|MODIFICATIONS TO THE MANUFACTURING PROCESS OF DISPENSING EPOXY ON A COMPONENT LOCATED ON THE PACEMAKER HYBRID.
P050037|S002|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2007|06/05/2007|||OK30|INSTALLATION OF ADDITIONAL STERILIZERS.
P050052|S003|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2007|06/05/2007|||OK30|INSTALLATION OF ADDITIONAL STERILIZERS.
P040013|S011|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH-FACTOR ENHANCED MATRIX|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2007|10/01/2007|||APPR|APPROVAL FOR A SCALE UP OF THE MANUFACTURING OF THE DRUG COMPONENT FOR THE GEM 21? COMBINATION PRODUCT.
P980016|S102|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC VIRTUOSO ICD (MODELS D154AWG AND D154VWC)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2007|06/06/2007|||APPR|APPROVAL FOR A CHANGE IN THE BAROMETRIC PRESSURE REQUIREMENT FROM 6 ATMOSPHERES ABSOLUTE (ATA) TO 4 ATA AND A CHANGE IN BAROMETRIC PRESSURE TESTING METHODOLOGY USED DURING DESIGN VERIFICATION.
P010031|S070|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CONCERTO CRT-D MODEL C154DWK|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2007|06/06/2007|||APPR|APPROVAL FOR A CHANGE IN THE BAROMETRIC PRESSURE REQUIREMENT FROM 6 ATMOSPHERES ABSOLUTE (ATA) TO 4 ATA AND A CHANGE IN BAROMETRIC PRESSURE TESTING METHODOLOGY USED DURING DESIGN VERIFICATION.
P000029|S032|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2007|10/30/2007|||APPR|APPROVAL FOR THE REMOVAL OF TWO OF THE VISUAL INSPECTION STEPS IN THE PRODUCTION PROCESS.
P970003|S082|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2007|06/15/2007|||APPR|APPROVAL TO ADD TWO ADDITIONAL IN-PROCESS QUALITY INSPECTION TESTS IN ORDER TO PROVIDE ADDITIONAL ASSURANCE OF RELIABILITY OF THE MODEL 102 AND MODEL 102R PULSE GENERATORS.
P840001|S097|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREULTRA RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2007|01/08/2008|||APPR|APPROVAL FOR THE RESTOREULTRA RECHARGEABLE NEUROSTIMULATION SYSTEM.  THE DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 6) PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS; 8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK SURGERIES.
P980040|S015|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2007|10/30/2007|||APPR|APPROVAL FOR TWO NEW MODELS OF SENSAR SOFT ACRYLIC UV LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) AND THE CLAIMS FOR REDUCED POSTOPERATIVE SPHERICAL ABERRATIONS AND IMPROVED NIGHT-DRIVING SIMULATOR PERFORMANCE.  THE NEW MODELS ARE SENSAR ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL AAB00) AND TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL ZCB00).  THE TWO MODELS DIFFER FROM THE PARENT MODELS AS FOLLOWS: SINGLE PIECE DESIGN, THE ADDITION OF A SURFACE TREATMENT TO THE ACRYLIC MATERIAL, AND SLIGHT REDUCTION IN THE CENTER THICKNESS WITH ZERO ANGULATION.
P050037|S003|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, 1.3 CC AND 0.3 CC|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2007|04/21/2008|||APPR|APPROVAL FOR A MODIFIED PRODUCT THAT CONTAINS PHOSPHATE BUFFER SOLUTION, HAS A LOWER EXTRUSION FORCE THAN THE ORIGINAL RADIESSE PRODUCT, AND IS MANUFACTURED USING A ONE-STEP PROCESS.
P050052|S004|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, 1.3 CC AND 0.3 CC|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2007|04/21/2008|||APPR|APPROVAL FOR A MODIFIED PRODUCT THAT CONTAINS PHOSPHATE BUFFER SOLUTION, HAS A LOWER EXTRUSION FORCE THAN THE ORIGINAL RADIESSE PRODUCT, AND IS MANUFACTURED USING A ONE-STEP PROCESS.
P850089|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP,Z,Z NOVUS,SP NOVUS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2007|06/15/2007|||OK30|CHANGE IN THE MOLDING VENDOR FOR THE RING TO PIN COMPONENT.
P010015|S028|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN LV,CS, BIPOLAR OTW|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2007|06/15/2007|||OK30|CHANGE IN THE MOLDING VENDOR FOR THE RING TO PIN COMPONENT.
P830061|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS & SENSE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2007|06/15/2007|||OK30|CHANGE IN THE MOLDING VENDOR FOR THE RING TO PIN COMPONENT.
P930039|S022|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SUREFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2007|06/15/2007|||OK30|CHANGE IN THE MOLDING VENDOR FOR THE RING TO PIN COMPONENT.
P890003|S121|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD-2|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2007|06/15/2007|||OK30|CHANGE IN THE MOLDING VENDOR FOR THE RING TO PIN COMPONENT.
P910023|S142|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2007|07/10/2007|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE HOUSECALL PLUS SYSTEM SOFTWARE (RECEIVER SOFTWARE MODEL 4000 VERSION 3.1) WHICH MERGES THE HOUSECALL RECEIVER 3.0.3 AND THE MATRIX PCS 2.0 SOFTWARE VERSION.
P020004|S023|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/21/2007|06/26/2007|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO EMPHASIZE THE APPROPRIATE WITHDRAWAL PROCEDURES FOR THE DELIVERY CATHETER AND SHEATH IF RESISTANCE IS FELT DURING REMOVAL.  THESE CHANGES INCLUDED MODIFICATIONS TO THE DIRECTIONS FOR USE AS WELL AS THE ADDITION OF A WARNING/ PRECAUTION REGARDING THE POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH FORCIBLY WITHDRAWING THE DELIVERY CATHETER THROUGH THE INTRODUCER SHEATH.
P020004|S024|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2007|06/05/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE FRONT OLIVE OF THE EXCLUDER DELIVERY SYSTEM.
P880086|S148|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2007|06/07/2007|||APPR|APPROVAL FOR THE MODEL 39565 SPECIFY 5-6-5 LEAD KIT.
P020026|S035|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice||N|05/21/2007|06/20/2007|||OK30|IMPLEMENTATION OF A VISUAL INSPECTION METHOD.
P020026|S036|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice||N|05/21/2007|06/20/2007|||OK30|ADDITION OF A "TIP ROUNDING" STEP TO THE CRIMP AND PACK UNIT MANUFACTURING OPERATION AND UPDATE OF THE VISUAL QUALITY STANDARD REQUIREMENTS FOR THE CATHETER DISTAL TIP.
P990066|S029|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2007|08/01/2007|||APPR|APPROVAL FOR MODIFICATIONS OF THE GE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM TO PERMIT USE IN MOBILE VANS.
P010030|S009|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WCD 3000|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2007|08/17/2007|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE LIFEVEST MODEL WCD 3000 BATTERY PACK TO IMPROVE ITS IMMUNITY TO AN ELECTROSTATIC DISCHARGE (ESD) EVENT.
P000039|S022|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER & MULTI-FENESTRATED SEPTAL OCCLUDER|MAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2007|10/05/2007|||APPR|APPROVAL FOR THE MODIFICATION OF THE DEVICE LOAD TEST FROM A MANUAL TO A PARTIALLY AUTOMATED PROCEDURE.
P020024|S016|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2007|10/05/2007|||APPR|APPROVAL FOR THE MODIFICATION OF THE DEVICE LOAD TEST FROM A MANUAL TO A PARTIALLY AUTOMATED PROCEDURE.
P010012|S150|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 & CONTAK RENEWAL 3 RF|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2007|06/22/2007|||OK30|CHANGE TO UPDATE THE VBAT LEAKAGE CURRENT TEST SOFTWARE.
P960040|S145|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2007|06/22/2007|||OK30|CHANGE TO UPDATE THE VBAT LEAKAGE CURRENT TEST SOFTWARE.
P040024|S009|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2007|06/05/2007|||OK30|NEW WATER SYSTEM AND A NEW SYSTEM FOR MANAGING MATERIALS AT THE Q-MED MANUFACTURING FACILITY.
P910077|S075|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2007|08/03/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRICAL ASSEMBLY, BUFFALO GROVE, ILLINOIS.
P000010|S010|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2007|02/06/2008|||APPR|APPROVAL FOR A MODIFICATION TO THE TESTING USED TO RELEASE TWO OLIGONUCLEOTIDE INTERMEDIATES FOR FURTHER MANUFACTURE.
P000012|S014|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2007|02/06/2008|||APPR|APPROVAL FOR A MODIFICATION TO THE TESTING USED TO RELEASE TWO OLIGONUCLEOTIDE INTERMEDIATES FOR FURTHER MANUFACTURE.
P970003|S083|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/24/2007|05/01/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P040047|S003|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2007|06/21/2007|||OK30|NES AUTOCLAVE FOR USE IN THE STERILIZATION OF COAPTITE.
N18286|S017|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM PLUS HEMOSTATIC KIT|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/24/2007|12/13/2007|||APPR|APPROVAL FOR A NEW KIT CONFIGURATION TO INCLUDE HUMAN THROMBIN.  THE KIT IS TO BE PREPARED AT THE BAXTER HEALTHCARE CORPORATION PLANT IN HAYWARD, CALIFORNIA.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GELFOAM PLUS HEMOSTASIS KIT AND IS INTENDED AS A HEMOSTATIC DEVICE FOR SURGICAL PROCEDURES WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS EITHER INEFFECTIVE OR IMPRACTICAL.
P900052|S015|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM|LNY|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2007|11/06/2007|||APPR|APPROVAL TO USE THE HERRMANN ULTRASONIC WELDER.
P980049|S027|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6260|MRM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/25/2007|10/23/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P010055|S004|PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|CORETHERM CATHETER|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2007|06/19/2007|||OK30|CHANGE IN THE MATERIAL USED IN THE IP-SEAL OF THE DEVICE.
P970003|S084|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2007|06/28/2007|||OK30|CHANGE FROM A DIRECT METALLIZATION PROCESS TO AN ELECTROLESS COPPER METHOD FOR THE PRINTED CIRCUIT BOARD MANUFACTURING PROCESS.
P000029|S033|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2007|06/18/2007|||OK30|CHANGES IN THE CALIBRATION METHOD FOR THE POUCH SEALING EQUIPMENT.
P020045|S022|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION CATHETERS & CCT. CRYOCONSOLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2007|06/29/2007|||OK30|CHANGE IN PACKAGE SEALING.
P000029|S034|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2007|03/20/2008|||APPR|APPROVAL FOR A SITE CHANGE FOR AN IN PROCESS TEST FOR THE DEVICE.
P920014|S027|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2007|06/29/2007|||OK30|ALTERNATE SUPPLIER FOR THE POLYMER USED TO MANUFACTURE THE DIAPHRAGM USED IN THE DEVICE.
P980041|S009|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/30/2007|09/12/2007|||APPR|APPROVAL FOR THE USE OF THE ACCESS AFP REAGENTS ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM.
P050018|S003|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT SCORING BALLOON CATHETER|NWX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2007|10/18/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ANGIOSCORE, INC., FREMONT, CALIFORNIA.
P030006|S014|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/13/2007|07/03/2007|||APPR|APPROVAL FOR MODIFICATION OF THE USER MANUAL AS REVISION E.
P060019|S002|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/31/2007|07/17/2007|||APPR|APPROVAL FOR A CHANGE FROM A SHAFT CONTAINING A PROXIMAL BRAIDED SECTION AND DISTAL NON-BRAIDED SECTION BRAIDED TUBING FOR BOTH PROXIMAL AND DISTAL SECTIONS.
P030022|S006|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2007|10/12/2007|||APPR|APPROVAL FOR THE ELIMINATION OF STERILIZATION CYCLE 204, A REDUCTION IN THE REQUIRED NUMBER OF PROCESS CHALLENGE DEVICES (PCD), THE INCREASE IN THE LENGTH OF PCD TUBING, A REDUCTION IN THE NUMBER OF PCDS THAT NEED TO BE TESTED WHEN SOME OF THE PCDS ARE DAMAGED OR LOST, AND A CHANGE IN THE PLACEMENT PATTERN FOR BIOLOGICAL INDICATORS.
P980016|S103|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2007|06/29/2007|||OK30|CHANGE IN VENDOR FOR THE 11V AND 22V ZENER DIODES USED IN THE HYBRID OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES.
P010031|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS FAMILIES OF INSYNC CRT ICDS & CONCERTO CRT-ICD|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2007|06/29/2007|||OK30|CHANGE IN VENDOR FOR THE 11V AND 22V ZENER DIODES USED IN THE HYBRID OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES.
P980050|S028|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2007|06/29/2007|||OK30|CHANGE IN VENDOR FOR THE 11V AND 22V ZENER DIODES USED IN THE HYBRID OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES.
P030047|S004|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE AND PRECISE RX NITINOL STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2007|06/29/2007|||OK30|ADDITION OF AN INSPECTION STEP IN THE PRODUCTION PROCESS OF THE DEVICE.
P880086|S149|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY,VERITY,INTEGRITY,VICTORY,ZEPHYR PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2007|10/29/2007|||APPR|APPROVAL FOR A MODIFICATION TO THE CLEANING PROCESS USED FOR THE HYBRIDS OF PACEMAKER DEVICES.
P030035|S033|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER & FRONTIER II CRT-PS|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2007|10/29/2007|||APPR|APPROVAL FOR A MODIFICATION TO THE CLEANING PROCESS USED FOR THE HYBRIDS OF PACEMAKER DEVICES.
P050033|S002|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|ELEVESS (AKA COSMETIC TISSUE AUGMENTATION PRODUCT)|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/31/2007|04/29/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P970055|S005|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|MYM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2007|10/10/2007|||APPR|APPROVAL FOR THE REDUCTION IN PLATE WASH VOLUME.
P830079|S017|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|Agent, absorbable hemostatic, collagen based|INSTAT COLLAGEN ABSORBABLE HEMOSTAT|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2007|11/28/2007|||APPR|APPROVAL FOR THE ADDITION OF THE MANUFACTURING FACILITY LOCATED IN NORTH YORKSHIRE, UNITED KINGDOM.
P970054|S005|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY|MYL|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2007|10/10/2007|||APPR|APPROVAL FOR THE REDUCTION IN PLATE WASH VOLUME.
P020001|S001|NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|STAN S31 FETAL HEART MONITOR|HEO|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2007|07/03/2007|||OK30|REDESIGN OF THE WIRING ARRANGEMENT WITHIN THE TRANSDUCER COMPONENT OF THE SYSTEM.
P990020|S026|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2007|07/03/2007|||OK30|IMPLEMENTATION OF AN INSPECTION FIXTURE TO AID IN THE CURRENT INSPECTION PROCESS TO CONFIRM BOND INTEGRITY.
P810046|S222|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER OTW CORONARY DILATATION CATHETER|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2007|09/27/2007|||APPR|APPROVAL FOR AN ADDITION OF A LUBRICIOUS COATING TO THE INNER LUMEN OF THE CATHETER.
P050012|S011|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEMS|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/2007|11/13/2007|||APPR|APPROVAL FOR CALIBRATION OF THE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM USING ANY FDA CLEARED BLOOD GLUCOSE METER.
P010021|S011|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2007|06/21/2007|||OK30|MODIFICATION TO THE FORMULATION OF A COMPONENT, WHICH IS THEN USED IN T HE MANUFACTURE OF THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK.
P040001|S007|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM|NQO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/2007|10/04/2007|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE TISSUE EXPANDER OF THE TITANIUM VERSION OF THE X-STOP SPACER ASSEMBLY.
P900056|S090|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/19/2007|10/03/2007|||APPR|APPROVAL FOR REVISIONS TO THE DIRECTIONS FOR USE FOR THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM, GUIDEWIRE WITH WIRECLIP TORQUER.
P060019|S003|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2007|07/26/2007|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE WHICH ADDED A VOLUME CONTROL TO THE AUDIBLE OUTPUT DEVICE TO PERMIT THE USER TO VARY THE VOLUME OF THE CONTINUOUS BEEPING SOUND MADE DURING RADIOFREQUENCY DELIVERY OF POWER.
P020004|S025|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2007|07/05/2007|||OK30|CHANGE TO THE METHOD OF MARKING OF DEVICE SIZE AND LOT NUMBER ON THE DELIVERY CATHETER FOR THE DEVICE.
P880003|S091|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PCTA DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2007|07/05/2007|||OK30|CHANGE IN THE ENVIRONMENTAL CONDITIONS OF THE MANUFACTURING FACILITY IN THE FABRICATION OF BALLOONS FOR THE PTCA DILATION CATHETERS.
P020026|S037|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2007|07/11/2007|||OK30|NEW RECEIVING INSPECTION ANALYTICAL TEST METHOD FOR NITROGEN, LIQUID NITROGEN, AND ARGON THROUGH GAS CHROMATOGRAPHY (GC) USING A THERMAL CONDUCTIVITY DETECTOR (TCD) FOR THE DEVICE.
P970003|S085|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/11/2007|10/23/2007|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY.
P980035|S074|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/11/2007|06/21/2007|||APPR|APPROVAL FOR CHANGES TO THE XD344 ZENER DIODE.
P950039|S018|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP 2000 SYSTEM|MKQ|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2007|08/30/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORP, MARLBOROUGH, MASSACHUSETTS.
P890003|S122|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/11/2007|06/21/2007|||APPR|APPROVAL FOR CHANGES TO THE XD344 ZENER DIODE.
P010015|S029|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/11/2007|06/21/2007|||APPR|APPROVAL FOR CHANGES TO THE XD344 ZENER DIODE.
P990001|S031|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/11/2007|06/21/2007|||APPR|APPROVAL FOR CHANGES TO THE XD344 ZENER DIODE.
P040024|S010|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2007|07/11/2007|||OK30|CHANGE IN A TESTING LABORATORY.
P000040|S011|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HTA SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/2007|07/16/2007|||APPR|APPROVAL FOR THE INCLUSION OF ADDITIONAL WARNINGS AND PRECAUTIONS TO MINIMIZE BURN INJURIES AND TO ENSURE PROPER HANDLING OF THE PROCEDURE SHEATH.
P840064|S032|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2007|08/30/2007|||APPR|APPROVAL FOR AN ADDITIONAL ALTERNATE STERILIZATION SITE AT STERIGENICS, WIESBADEN, GERMANY.
P890047|S019|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2007|08/30/2007|||APPR|APPROVAL FOR AN ADDITIONAL ALTERNATE STERILIZATION SITE AT STERIGENICS, WIESBADEN, GERMANY.
P960028|S022|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL INTRAOCULAR LENSES (IOLS)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2007|07/10/2007|||OK30|REDUCTION OF THE TOTAL PROCESS TIME.
P980040|S016|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2007|07/10/2007|||OK30|REDUCTION OF THE TOTAL PROCESS TIME.
P990080|S025|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2007|07/10/2007|||OK30|REDUCTION OF THE TOTAL PROCESS TIME.
P990037|S025|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/14/2007|07/17/2007|||APPR|APPROVAL FOR THE ADDITION OF THE FOLLOWING WARNING TO THE LABELING: ?THE SAFETY AND EFFECTIVENESS OF D-STAT HAS NOT BEEN ESTABLISHED FOR USE TO CONTROL BLEEDING FOLLOWING ORGAN OR TISSUE BIOPSIES.  USE OF D-STAT IN THIS SITUATION HAS BEEN REPORTED TO RESULT IN PAIN, SEIZURES, BILE RETENTION, TISSUE NECROSIS, VASCULAR OCCLUSION AND DEATH.?
P880003|S092|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|CORDIS PTCA DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2007|07/13/2007|||OK30|CHANGE THE HIGH-DENSITY POLYETHYLENE (HDPE) FORMING TUBE EXTRUSION PROCESS FROM AIR EXTRUSION TO VACUUM EXTRUSION.
P890003|S123|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR PROGRAMMER MODEL 2090|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/15/2007|10/16/2007|||APPR|APPROVAL FOR SOFTWARE MODEL SW0007.
P030006|S015|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2007|07/10/2007|||OK30|SIX CHANGES: 1) REVISED WORK IN PROGRESS MANAGEMENT PROCEDURE; 2) A PROCESS DOCUMENT CHANGE; 3) CHANGE IN THE FREQUENCY OF A MAINTENANCE SCHEDULE; 4) CHANGE IN THE IDENTIFICATION OF A PART; 5) CHANGE IN THE TOLERANCE OF A PART; AND 6) CHANGE IN A SUBASSEMBLY TEST.
P010012|S151|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEW 3 RF|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/18/2007|08/24/2007|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE CONTAK RENEWAL 3 RF MODELS H210, H215, H217, AND H219: 1) DIGITAL IC PAD CHANGE TO ADDRESS PREMATURE BATTERY DEPLETION.  2) HYBRID MOTHERBOARD DFN TRACE RE-ROUTING FROM OUTSIDE LAYER ?4? TO AN INSIDE LAYER ?3? TO REDUCE ELECTRICAL FIELD INTENSITY AND POSSIBLE ARCING.  3) TRIM TARGET ADJUSTMENT.
P020004|S026|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2007|11/09/2007|||APPR|APPROVAL FOR THE CRUSH/LOADING OPERATION AND DESTRUCTIVE TESTING (QC) OPERATION TO BE PERFORMED AT THE FLAGSTAFF ARIZONA FACILITY.
P020026|S038|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2007|11/21/2007|||APPR|APPROVAL FOR A CHANGE IN CLASSIFICATION OF DELAMINATION DEFECT AND SEALING PARAMETERS.
P940015|S012|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC-ONE|MOZ|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/19/2007|02/26/2009|09M-0128|03/10/2009|APPR|APPROVAL FOR THE SYNVISC-ONE.  THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P980022|S020|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CGMS IPRO SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2007|01/22/2008|||APPR|APPROVAL FOR THE CGMS IPRO SYSTEM. THE CGMS IPRO SYSTEM INCLUDES THE CGMS IPRO DIGITAL RECORDER, SOLUTIONS SOFTWARE FOR CGMS IPRO,  COMLINK IPRO, AND CGMS IPRO WAND.  THE DEVICE IS INTENDED TO CONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS.  THE INFORMATION IS INTENDED TO SUPPLEMENT, NOT REPLACE, BLOOD GLUCOSE INFORMATION OBTAINED USING A STANDARD HOME GLUCOSE-MONITORING DEVICE.  THE INFORMATION COLLECTED BY THE CGMS IPRO DIGITAL RECORDER MAY BE DOWNLOADED, USING THE COMLINK IPRO, THE SOLUTIONS SOFTWARE FOR CGMS IPRO AND A PERSONAL COMPUTER, AND REVIEWED BY HEALTHCARE PROFESSIONALS.  THE INFORMATION MAY ALLOW IDENTIFICATION OF PATTERNS OF GLUCOSE LEVEL EXCURSIONS ABOVE OR BELOW THE DESIRED RANGE, FACILITATING THERAPY ADJUSTMENTS WHICH MAY MINIMIZE THESE EXCURSIONS.
P040024|S011|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GELS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2007|07/06/2007|||OK30|CHANGE TO ONE TEST METHOD USED IN THE LABORATORY.
P020026|S039|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2007|10/26/2007|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLING PLAN FOR BALLOON ATTRIBUTE FUNCTIONAL TESTS CONDUCTED AT THE CRIMP AND PACK UNIT OPERATION.
P990064|S018|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/19/2007|08/29/2007|||APPR|APPROVAL TO REDUCE THE BIOPROSTHESIS RINSING TIME PRIOR TO IMPLANTATIONS.  THE REQUEST APPLIES TO ALL SIZES OF THE AORTIC AND MITRAL MOSAIC BIOPROSTHESIS.
P980043|S012|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHESIS|DYE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/19/2007|08/29/2007|||APPR|APPROVAL TO REDUCE THE BIOPROSTHESIS RINSING TIME PRIOR TO IMPLANTATION.  THE APPROVAL APPLIES TO ALL SIZES OF THE AORTIC AND MITRAL HANCOCK II BIOPROSTHESIS.
P900060|S039|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2007|11/30/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SORIN BIOMEDICA CARDIO S.R.L., SALUGGIA (VERCELLI), ITALY.
P030017|S025|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CONNECTOR-M1|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2007|10/30/2007|||APPR|APPROVAL FOR THE PRECISION OMG (OBSERVATIONAL MECHANICAL GATEWAY) CONNECTOR-M1, MODELS SC-9004-35, SC-9004-55, AND SC-9004-70.
P990004|S012|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2007|12/13/2007|||APPR|APPROVAL FOR THE ADDITION OF CLINICAL RESULTS TO THE PRODUCT LABELING WITH AN UPDATE TO THE DIRECTIONS FOR USE TO ALLOW USE IN ENDOSCOPIC NASAL SINUS SURGERY AND ADDITION OF A BENDABLE APPLICATOR TIP (FLEXTIP).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P. AND IS INDICATED FOR AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES.
P880086|S150|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|INDENTITY & IDENTITY ADX FAMILY OF DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2007|07/12/2007|||APPR|APPROVAL FOR USE OF THE CIRCUITRY USE DIN THE ANALOG CHIP IN THE VICTORY/ZEPHYR FAMILY OF DEVICES IN THE ANALOG CHIP USED IN THE IDENTITY AND IDENTITY ADX FAMILY OF DEVICES, AND FOR RESIZING THE SENSE AND IEGM GAIN  CAPACITORS.
P950027|S009|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN|MOZ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2007|05/01/2008|||APPR|APPROVAL FOR THE MODIFICATION OF THE MANUFACTURING PROCESS FOR HYALGAN FOR PRODUCING HYALURONATE BY A BACTERIAL FERMENTATION AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY, AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P020004|S027|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2007|09/04/2007|||APPR|APPROVAL FOR MACHINE-ASSISTED STENT WINDING EQUIPMENT AS AN ALTERNATE PROCESS IN THE MANUFACTURE OF THE DEVICE.
P810006|S028|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2007|07/20/2007|||OK30|CHANGE IN CLEANING MANUFACTURING EQUIPMENT USED IN THE LYOPHILIZATION PROCESS.
P850010|S025|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2007|07/20/2007|||OK30|CHANGE IN CLEANING MANUFACTURING EQUIPMENT USED IN THE LYOPHILIZATION PROCESS.
P840062|S013|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2007|07/24/2007|||OK30|CHANGE IN CLEANING MANUFACTURING EQUIPMENT USED IN THE LYOPHILIZATION PROCESS.
P860004|S090|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED PUMP AND INFUSION SYSTEM (SYNCHROMED EL AND SYNCHROMED II)|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/22/2007|11/10/2008|||APPR|APPROVAL FOR THE SOFTWARE CHANGES MADE TO THE SYNCHROMED EL AND SYNCHROMED II APPLICATION SOFTWARE LOCATED ON MODEL 8870 APPLICATION CARD.
P950037|S052|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS FAMILY OF PULSE GENERATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2007|07/25/2007|||OK30|CHANGE WHERE THE CABLES ARE PACKAGED.
P980023|S028|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX S AND LINOX T ICD LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2007|07/25/2007|||OK30|CHANGE WHERE THE CABLES ARE PACKAGED.
P050023|S005|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF CRT-DS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2007|07/25/2007|||OK30|CHANGE WHERE THE CABLES ARE PACKAGED.
P910023|S143|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2007|07/24/2007|||OK30|ENHANCEMENTS TO THE HYBRID SUBSTRATE ATTACHMENT PROCESS.
P030054|S059|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2007|07/24/2007|||OK30|ENHANCEMENTS TO THE HYBRID SUBSTRATE ATTACHMENT PROCESS.
P030039|S005|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2007|07/24/2007|||OK30|EXPANSION OF THE ISO CLASS 7 CLEANROOM AND THE INSTALLATION OF A LARGER WATER DELIVERY PUMP.
P020014|S014|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2007|08/07/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE FROM CONCEPTUS, INC. IN MOUNTAIN VIEW, CALIFORNIA TO A CONTRACT MANUFACTURER IN CHIHUAHUA, MEXICO.
P990081|S006|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY HER-2/NEU CONTROL SLIDES|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2007|07/24/2007|||OK30|CHANGE IN ACCEPTANCE TESTING FOR THE CONTROL SLIDE LOT RELEASE TESTING.
P000025|S024|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice||N|06/27/2007|07/24/2007|||OK30|ADDITION OF TWO CLEANROOM MODULES TO PROVIDE ADDITIONAL WORK SPACE FOR ELECTRODE MANUFACTURING.
P850089|S056|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP & CAPSURE Z|NVY|CV|30-Day Notice||N|06/27/2007|07/27/2007|||OK30|CHANGE IN THE MOLDING VENDOR FOR THE IS-1 CONNECTOR SLEEVE COMPONENT FROM MEDTRONIC PUERTO RICO OPERATIONS COMPANY TO FMI, INC.
P930039|S023|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SUREFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2007|07/27/2007|||OK30|CHANGE IN THE MOLDING VENDOR FOR THE IS-1 CONNECTOR SLEEVE COMPONENT FROM MEDTRONIC PUERTO RICO OPERATIONS COMPANY TO FMI, INC.
P010015|S030|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC ATTAIN OTW LV LEAD MODEL 4193|LWP|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2007|02/14/2008|||APPR|APPROVAL TO ADD AN UPDATED VERSION OF THE POST-APPROVAL STUDY SUMMARY FOR THE ATTAIN OTW LV LEAD MODEL 4193 TO THE DEVICE LABELING.
P010020|S005|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2007|07/27/2007|||OK30|CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.
P920023|S021|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME URETHRAL STENT|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2007|07/27/2007|||OK30|CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.
P000053|S009|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2007|07/27/2007|||OK30|CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.
P000032|S021|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2007|07/27/2007|||OK30|CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.
P000043|S018|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATRX OFFICE THERMOTHERAPY SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2007|07/27/2007|||OK30|CHANGE IN THE LABEL GENERATION SYSTEM FOR THE DEVICE.
P000025|S025|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2007|07/24/2007|||OK30|REMOVAL OF THE PRE-CLEANING STEP FOR THE DEVICE.
P040023|S009|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/02/2007|09/03/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P990064|S019|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2007|11/29/2007|||APPR|APPROVAL FOR THE ADDITION OF A BORATE BUFFERED SALINE (BBS) SOLUTION PRE-RINSE TO THE P5 AMINO-OLEIC ACID (AOA) PROCESS.
P970031|S019|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2007|11/29/2007|||APPR|APPROVAL FOR THE ADDITION OF A BORATE BUFFERED SALINE (BBS) SOLUTION PRE-RINSE TO THE P5 AMINO-OLEIC ACID (AOA) PROCESS.
P010020|S006|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER|MIP|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2007|04/16/2008|||APPR|APPROVAL FOR A CHANGE IN THE RELEASE AGENT USED IN THE DISPERSION PROCESS.
P000053|S010|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2007|04/16/2008|||APPR|APPROVAL FOR A CHANGE IN THE RELEASE AGENT USED IN THE DISPERSION PROCESS.
P870072|S037|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC TLC-II PORTABLE VAD DRIVER|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2007|11/14/2007|||APPR|APPROVAL FOR REDUCING THE MAINTENANCE SERVICE INTERVAL FOR THE TLC II PORTABLE VAD DRIVER TO 1500 HOURS FROM THE CURRENT 3000 HOUR INTERVAL.
P980037|S023|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHELYTIC THROMBECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2007|08/02/2007|||OK30|ALTERNATE COMPONENT VENDOR FOR THE SUBJECT DEVICE.
P990004|S013|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/05/2007|12/27/2007|||APPR|APPROVAL FOR THE REMOVAL OF THE UROLOGIC PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT.
P950022|S040|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2007|09/06/2007|||APPR|APPROVAL FOR DISTAL TIP CHANGES TO THE RIATA ST OPTIM LEAD FAMILY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA STS OPTIM LEAD MODELS 7120, 7121, 7122, 7130 AND 7131, AND ARE INDICATED FOR USE AS TRANSVENOUS, STEROID ELUTING, RIGHT VENTRICULAR DUAL AND SINGLE DEFIBRILLATION COIL LEADS WITH COMPATIBLE PULSE GENERATORS.
P860057|S042|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/2007|05/07/2009|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING MODIFICATIONS TO THE CARPENTIER-EDWARDS PERIMOUNT  MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESES, MODEL 3000TFX,INCLUDING CHANGES TO THE ELGILOY BAND AND THE POLYESTER BAND. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME CARPENTIER -EDWARDS PERIMOUNT  MAGNA EASE PERICARDIALAORTIC BIOPROSTHESES. MODEL 3300TFX, AND IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OFTHEIR NATIVE OR PROSTHETIC AORTIC VALVE.
P000043|S019|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2007|08/03/2007|||OK30|MOVE A MANUFACTURING PROCESS FROM A CONTRACT MANUFACTURER IN SALT LAKE CITY, UTAH, TO THE FINAL ACCEPTANCE ACTIVITY  SITE AT AMERICAN MEDICAL SYSTEMS, MINNETONKA, MINNESOTA.
P900009|S027|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 4000+BONE HEALING SYSTEM|LPQ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/10/2007|08/16/2007|||APPR|APPROVAL FOR CHANGES IN INTERNAL DEVICE CIRCUITRY AS MITIGATION AGAINST KNOWN DEVICE FAILURE MECHANISMS WHICH DO NOT IMPACT UPON ULTRASOUND OUTPUT OR SIGNAL PARAMETERS.
P000039|S023|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM|MAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2007|12/04/2007|||APPR|APPROVAL FOR AGA MEDICAL CORPORATION TO BECOME THE PRIMARY SOURCE FOR THE LASER WELDING PROCESS, WHILE RETAINING THE CURRENT VENDOR AS A SECONDARY SOURCE.
P020024|S017|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2007|12/04/2007|||APPR|APPROVAL FOR AGA MEDICAL CORPORATION TO BECOME THE PRIMARY SOURCE FOR THE LASER WELDING PROCESS, WHILE RETAINING THE CURRENT VENDOR AS A SECONDARY SOURCE.
P020002|S003|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP IMAGING SYSTEM|MNM|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2007|08/30/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC, MARLBOROUGH, MASSACHUSETTS.
P910071|S010|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL|LWL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2007|12/12/2007|||APPR|APPROVAL FOR A PACKAGING CHANGE WHICH INVOLVES THE ADDITION OF A RIGID TIP CAP TO THE 10 CC GLASS SYRINGE PACKAGING CONFIGURATION TO INCORPORATE A RIGID POLYPROPYLENE HOUSING AROUND THE ELASTOMER SEAL.
P970008|S033|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2007|04/15/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA FOR THE MANUFACTURING OF THE COOLANT BAG KITS.
P980016|S104|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2007|08/10/2007|||OK30|CHANGES INCLUDING: 1) MOVING THE ACCELEROMETER TESTING OPERATION EARLIER IN THE MANUFACTURING FLOW; 2) MOVING THE PATIENT ALERT RESTING OPERATION EARLIER IN THE MANUFACTURING PROCESS; AND 3) PERFORMING THE MEDICAL ADHESIVE CURING AND DEVICE PRE-HEAT PROCESS IN A SINGLE OVEN.
P010031|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2007|08/10/2007|||OK30|CHANGES INCLUDING: 1) MOVING THE ACCELEROMETER TESTING OPERATION EARLIER IN THE MANUFACTURING FLOW; 2) MOVING THE PATIENT ALERT RESTING OPERATION EARLIER IN THE MANUFACTURING PROCESS; AND 3) PERFORMING THE MEDICAL ADHESIVE CURING AND DEVICE PRE-HEAT PROCESS IN A SINGLE OVEN.
P010031|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC ICD MODEL INSYNC 7272 SYSTEM|NIK|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2007|09/13/2007|||APPR|APPROVAL FOR A LABELING UPDATE TO ADD A CLINICAL SUMMARY FOR THE COMPLETED INSYNC ICD MODEL 171 POST-APPROVAL STUDY.
P050023|S006|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/2007|12/07/2007|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION A-K00.10U OF THE PMS/TMS 1000, AND APPLICATION SOFTWARE VERSION 703.U/1 OF THE ICS 3000.
P000009|S022|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LEXOS DR/VR(-T) ICDS & LUMOS VR/DR (-T) & XELOS DR-T ICD & BELOS DR (-T) ICDS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/2007|12/07/2007|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION A-K00.10U OF THE PMS/TMS 1000, AND APPLICATION SOFTWARE VERSION 703.U/1 OF THE ICS 3000.
P980023|S029|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/2007|12/07/2007|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION A-K00.10U OF THE PMS/TMS 1000, AND APPLICATION SOFTWARE VERSION 703.U/1 OF THE ICS 3000.
P950037|S053|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/2007|12/07/2007|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION A-K00.10U OF THE PMS/TMS 1000, AND APPLICATION SOFTWARE VERSION 703.U/1 OF THE ICS 3000.
P820003|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 5388 EXTERNAL PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2007|08/10/2007|||OK30|MINOR MODIFICATION TO A COMPONENT INSPECTION PROCEDURE OCCURRING AT A FINISHED DEVICE CONTRACT MANUFACTURING SUPPLIER.
P030005|S044|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2007|08/10/2007|||OK30|MODIFICATIONS TO THE CLEAN PROCESS RECIPE FOR CONTAK RENEWAL TR HYBRIDS.
P010012|S152|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2 FAMILY OF LEADS|LWP|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2007|11/09/2007|||APPR|APPROVAL TO CHANGE THE MEDICAL ADHESIVE USED FOR THE EASYTRAK  2 FAMILY OF LEADS.
P010032|S021|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ANS EON C (IPG) NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/2007|12/10/2007|||APPR|APPROVAL FOR THE USE OF THE ANS EONC (IPG) NEUROMODULATION SYSTEM, MODEL 3688 WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMB, INCLUDING UNILATERAL AND BILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND INTRACTABLE LOW BACK AND LEG PAIN.
P970021|S015|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARETHERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2007|11/05/2007|||APPR|APPROVAL FOR A CHANGE IN THE ETHYLENE OXIDE STERILIZATION CYCLE.
P910073|S067|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE ACTIVE FIX & RELIANCE PASSIVE FIX STERIOD ELUTING ENDOCARDIAL DEFIBRILLATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2007|08/15/2007|||OK30|ADDITION OF A NEW PIECE OF INSPECTION EQUIPMENT FOR ACCEPTANCE TESTING OF TUBING COMPONENTS.
P830055|S099|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM-RPF FEMORAL COMPONENT LINE EXTENSION|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/2007|08/14/2007|||APPR|APPROVAL FOR THE ADDITION OF AN INTERMEDIATE SIZE P.F.C. SIGMA 4N RPF FEMORAL COMPONENT.
P050016|S001|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/16/2007|10/18/2007|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P820060|S022|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT AXSYM AFP|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/2007|03/26/2008|||APPR|APPROVAL FOR RE-STANDARDIZATION OF THE MANUFACTURING PROCESS FOR AXSYM AFP CALIBRATORS AND CONTROLS AGAINST THE WORLD HEALTH ORGANIZATION (WHO) FIRST INTERNATIONAL STANDARD 72/225 OR ALPHA-FETOPROTEIN (AFP).
P010001|S004|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2007|08/17/2007|||OK30|IMPLEMENTATION OF NEW SOFTWARE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF TWO INNER SPHERE POLISHING STATIONS.
P000025|S026|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2007|03/14/2008|||APPR|APPROVAL FOR THE DACAPO SYSTEM WHICH IS AN ALTERNATIVE RECHARGEABLE BATTERY PACK TO POWER THE BEHIND-THE-EAR SPEECH PROCESSOR, AN EXTERNAL COMPONENT OF THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.
P910023|S144|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice||N|07/19/2007|08/17/2007|||OK30|ALTERNATE SUPPLIER FOR THE ISOLATION TRANSFORMER MODULE (ITM) AND TOROID INDUCTOR USED ON THE HIGH VOLTAGE HYBRID ASSEMBLY OF THE CURRENT ICDS AND PROMOTE CRT-DS.
P030054|S060|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice||N|07/19/2007|08/17/2007|||OK30|ALTERNATE SUPPLIER FOR THE ISOLATION TRANSFORMER MODULE (ITM) AND TOROID INDUCTOR USED ON THE HIGH VOLTAGE HYBRID ASSEMBLY OF THE CURRENT ICDS AND PROMOTE CRT-DS.
P910023|S145|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice||N|07/19/2007|08/17/2007|||OK30|ALTERNATE SUPPLIER FOR THE DIODE DIE, SILICON, 20V, 5%, ZENAR VOLTAGE REGULATORY, AND THE DIODE DIE, HIGH VOLTAGE, HIGH CURRENT COMPONENTS FOR THE DEVICE.
P920023|S022|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|AMS UROLUME ENDOPROSTHESIS|MES|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/2007|08/08/2007|||APPR|APPROVAL FOR A LABELING CHANGE TO ADD HYPOSPADIAS AS A PRECAUTION WHEN USING THE UROLUME FOR THE TREATMENT OF RECURRENT BULBAR URETHRAL STRICTURES.
P030054|S061|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice||N|07/19/2007|08/17/2007|||OK30|ALTERNATE SUPPLIER FOR THE DIODE DIE, SILICON, 20V, 5%, ZENAR VOLTAGE REGULATORY, AND THE DIODE DIE, HIGH VOLTAGE, HIGH CURRENT COMPONENTS FOR THE DEVICE.
P910023|S146|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice||N|07/19/2007|08/17/2007|||OK30|ALTERNATE SUPPLIER FOR THE PARYLENE DIMER USED IN THE PARYLENE COATING FOR THE DEVICE.
P030054|S062|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice||N|07/19/2007|08/17/2007|||OK30|ALTERNATE SUPPLIER FOR THE PARYLENE DIMER USED IN THE PARYLENE COATING FOR THE DEVICE.
P050025|S005|BOSTON SCIENTIFIC|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CAROTID|NEXSTENT STENT AND MONORAIL DELIVERY SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2007|08/17/2007|||OK30|ADDITION OF A SECOND ETO STERILIZATION CHAMBER AT THE STERIGENICS WILLOWBROOK (WB) STERILIZATION FACILITY.
P820003|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODELS 5348 AND 5388 EXTERNAL PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/19/2007|09/28/2007|||APPR|APPROVAL FOR MINOR DESIGN CHANGES AND INTERNAL COMPONENT UPDATES TO MEDTRONIC MODEL 5348 AND MODEL 5388 EXTERNAL PULSE GENERATORS.
P990040|S005|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2007|10/15/2007|||APPR|APPROVAL FOR A CHANGE IN THE CLEANING PROCESS AND INSPECTION OF PRODUCT CONTAINERS.
P900009|S028|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2007|08/16/2007|||OK30|CHANGE IN THE MANUFACTURE OF THE EXOGEN 4000+ DEVICE TO A CONTINUOUS FLOW MANUFACTURING MODEL AND A CHANGE IN THE SERIAL NUMBERING SCHEME OF THE DEVICE.
P790017|S087|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|SPRINTER OVER-THE-WIRE BALLOON DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2007|08/22/2007|||OK30|ADDING THE OPTION TO STERILIZE THE SUBJECT DEVICE TWICE.
P020003|S005|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Prosthesis, testicular|COLOPLAST SALINE-FILLED TESTICULAR IMPLANT|FAF|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/2007|10/09/2007|||APPR|APPROVAL FOR LABELING CHANGES TO REPORT POST APPROVAL STUDY RESULTS.
P960040|S146|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, VITALITY AND CONTAK RENEWAL FAMILIES OF DEVICES|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/2007|10/18/2007|||APPR|APPROVAL FOR MINOR LABELING CHANGES FOR THE PRIZM, VITALITY AND CONTAK RENEWAL FAMILIES OF DEVICES.
P010012|S153|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/2007|10/18/2007|||APPR|APPROVAL FOR MINOR LABELING CHANGES FOR THE PRIZM, VITALITY AND CONTAK RENEWAL FAMILIES OF DEVICES.
P000027|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA IMMUNOASSAY, PSA CALSET & PSA CALCHECK|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/2007|03/03/2009|||APPR|APPROVAL FOR EXTENSION OF THE ELECSYS TOTAL PSA SYSTEM ONTO AN UPDATED MODEL OF THE MODULAR ANALYTICS E170 ANALYZER, KNOWN AS THE COBAS E411 ANALYZER.
P950042|S004|NOVADAQ TECHNOLOGIES, INC.|2585 SKYMARK AVENUE, STE. 306||MISSISSAUGA, ONTARIO||L4W 4||SYSTEM, IMAGING, FLUORESCENCE|PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA|MRK|EN|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/18/2007|09/05/2007|||APPR|APPROVAL FOR A TRADE NAME CHANGE FROM ONCO-LIFE TO PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA.
P950005|S021|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS,CELSIUS II, CELSIUS RMT, EZ STEER, EZ STEER DS DIAGNOSTIC/ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2007|08/23/2007|||OK30|INCREASING THE STERILIZATION PALLET SIZE FORM A 6-PALLET LOAD TO A 10-PALLET LOAD.
P030032|S007|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|PREVELLE SILK|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/2007|02/26/2008|||APPR|APPROVAL FOR THE ADDITION OF PHOSPHATE BUFFERED SALINE (PBS) AND LIDOCAINE HYDROCHLORIDE (HCL).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PREVELLE SILK AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
P000041|S006|RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|ONGUARD|MYN|RA|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/2007|08/30/2007|||APPR|APPROVAL FOR A NEW TRADE NAME.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ONGUARD AND IS INDICATED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON FRONTAL CHEST RADIOGRAPHIC FILMS FROM ADULT MALES WITH AN INCREASED RISK FOR LUNG CANCER TO BRING ROIS TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED.  THUS THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL CHEST FILMS THAT MAY WARRANT A SECOND REVIEW.
P000010|S011|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HEPATITIS C VIRUS (HCV) TEST|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2007|01/11/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., PLEASANTON, CALIFORNIA FOR BULK POSITIVE CONTROL STOCK MANUFACTURING.
P000012|S015|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2007|01/11/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., PLEASANTON, CALIFORNIA FOR BULK POSITIVE CONTROL STOCK MANUFACTURING.
P050025|S006|BOSTON SCIENTIFIC|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CAROTID|NEXSTENT CAROTID STENT AND MONORAIL DELIVERY SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2007|08/24/2007|||OK30|ADDITION OF A 100% INSPECTION TEST TO BE IMPLEMENTED IN RECEIVING INSPECTION AND A 100% IN-PROCESS VISUAL VERIFICATION TO ENSURE THAT CONNECTOR BLOCKS PROPERLY TRANSMIT UV LIGHT.
P980035|S075|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 900|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2007|09/18/2007|||APPR|APPROVAL FOR A CHANGE TO THE XM485 AND XM486 WIRE BOND TERMINAL BLOCKS FOUND IN MEDTRONIC KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA, SIGMA, 350 SERIES, THERA/PRODIGY, KAPPA 400, AND INSYNC-II IMPLANTABLE PULSE GENERATOR AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILIES.
P970012|S028|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2007|09/18/2007|||APPR|APPROVAL FOR A CHANGE TO THE XM485 AND XM486 WIRE BOND TERMINAL BLOCKS FOUND IN MEDTRONIC KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA, SIGMA, 350 SERIES, THERA/PRODIGY, KAPPA 400, AND INSYNC-II IMPLANTABLE PULSE GENERATOR AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILIES.
P010015|S031|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2007|09/18/2007|||APPR|APPROVAL FOR A CHANGE TO THE XM485 AND XM486 WIRE BOND TERMINAL BLOCKS FOUND IN MEDTRONIC KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA, SIGMA, 350 SERIES, THERA/PRODIGY, KAPPA 400, AND INSYNC-II IMPLANTABLE PULSE GENERATOR AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILIES.
P890003|S124|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|THERA/PRODIGY|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2007|09/18/2007|||APPR|APPROVAL FOR A CHANGE TO THE XM485 AND XM486 WIRE BOND TERMINAL BLOCKS FOUND IN MEDTRONIC KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA, SIGMA, 350 SERIES, THERA/PRODIGY, KAPPA 400, AND INSYNC-II IMPLANTABLE PULSE GENERATOR AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILIES.
P040052|S004|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|MONOPREP PAP TEST|MKQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|07/27/2007|08/31/2007|||APPR|APPROVAL FOR USE OF REFLECTIVE WHITE LABEL STOCK (PN 12358) ON ALL MONOPREP VIALS, INCLUDING THE MONOPREP PAP TEST VIAL AND THE REPROCESSING VIAL.
P790017|S088|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2007|08/29/2007|||OK30|ADDING ISOTRON IRELAND, ONE OF MEDTRONIC?S APPROVED CONTRACT ETHYLENE OXIDE (ETO) STERILIZATION FACILITIES, TO RECEIVE, STORE, AND PREPARE BIOLOGICAL INDICATORS FOR ROUTINE STERILIZATION CYCLES AND TO COMPLETE VIABILITY TESTING.
P030009|S009|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2007|08/29/2007|||OK30|CHANGE OF PROCESSING ADDITIONAL CATHETERS AT THE COATING STAGE.
P000058|S025|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2007|01/14/2008|||APPR|APPROVAL FOR THE ADDITION OF A NEW VALIDATED CROSS-LINKING CHAMBER.
P000054|S013|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2007|01/14/2008|||APPR|APPROVAL FOR THE ADDITION OF A NEW VALIDATED CROSS-LINKING CHAMBER.
P050053|S004|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2007|01/14/2008|||APPR|APPROVAL FOR THE ADDITION OF A NEW VALIDATED CROSS-LINKING CHAMBER.
P970055|S006|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|MYM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2007|08/24/2007|||OK30|CHANGE IN PACKAGING MATERIAL.
P970054|S006|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY|MYL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2007|08/24/2007|||OK30|CHANGE IN PACKAGING MATERIAL.
P990025|S013|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2007|08/23/2007|||OK30|INCREASING THE STERILIZATION PALLET SIZE FORM A 6-PALLET LOAD TO A 10-PALLET LOAD.
P010068|S010|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR RMT DS CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2007|08/23/2007|||OK30|INCREASING THE STERILIZATION PALLET SIZE FORM A 6-PALLET LOAD TO A 10-PALLET LOAD.
P790017|S091|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER, NC STORMER MX2|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2007|08/30/2007|||OK30|REDUCTION IN THE NUMBER OF SAMPLES SUBMITTED FOR END OF LINE QUALITY CONTROL FUNCTION TESTING OF THE DEVICE.
P030009|S013|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2007|02/15/2008|||APPR|APPROVAL TO MODIFY THE SOFTWARE PROGRAM USED IN THE STENT ASSEMBLY WELDING PROCESS.
P790017|S092|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2)|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2007|08/30/2007|||OK30|REDUCTION IN THE NUMBER OF SAMPLES SUBMITTED FOR IN-PROCESS QUALITY CONTROL TENSILE TESTING OF THE DEVICE.
P030009|S014|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO-DRIVER CORONARY STENT SYSTEM (MX2 & OTW)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2007|08/30/2007|||OK30|CHANGE TO THE FORM TOOL EQUIPMENT USED IN THE MANUFACTURE OF THE DEVICE.
P030009|S015|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2007|08/30/2007|||OK30|REDUCTION IN THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.
P970035|S047|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|S-SERIES CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2007|08/30/2007|||OK30|REDUCTION IN THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.
P840062|S014|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|HELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/2007|10/30/2007|||APPR|APPROVAL FOR THE ADDITION OF TWO NEW TRADE NAMES - HELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY.
P970003|S086|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/02/2007|08/30/2007|||APPR|APPROVAL FOR A MATERIAL CHANGE TO THE MODEL 220 PATIENT ESSENTIALS KIT PATIENT MAGNET.
P890055|S020|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 IMPLANTABLE INFUSION PUMP|LKK|HO|30-Day Notice||N|08/06/2007|08/23/2007|||OK30|CHANGE 1) IN PACKAGING LOCATION FOR THE BARBED CATHETER CONNECTOR TO AN IN-HOUSE PROCEDURE AT CODMAN & SHURTLEFF, RAYNHAM, MASSACHUSETTS FROM AVID MEDICAL, ROANO, VIRGINIA, AND 2) CHANGE IN THE BARBED CATHETER CONNECTOR PACKAGING TO THE APPROVED PACKAGING FOR THE FLEX 1 REPLACEMENT CONNECTOR.
P890055|S021|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|GEM MODEL 7227 IMPLANTABLE DEVICE|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2007|09/07/2007|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX, NORTHBOROUGH, MASSACHUSETTS.
P010032|S022|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/06/2007|11/05/2007|||APPR|APPROVAL FOR THE PEEK-OPTIMA ANTENNA COVER.
P040020|S005|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL|MFK|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/06/2007|10/24/2007|||APPR|APPROVAL FOR EXPANSION OF THE DIOPTRIC RANGE OF THE REFERENCED MODELS FROM 10.0D TO 30.0D TO 6.0D TO 30.0D.  THE DEVICE MODELS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODELS SA60D3, SN60D3, MA60D3 AND MN60D3, AND ARE INDICATED FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE.  THESE LENSES ARE INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
P010003|S011|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/06/2007|10/18/2007|||APPR|APPROVAL FOR A CHANGE TO THE STERILE 5 ML SYRINGE PRODUCT.
P960016|S019|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|SAFIRE CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/2007|09/24/2007|||APPR|APPROVAL FOR LABELING MODIFICATIONS THAT ALLOWS: 1) THE IBI-1500T6 AND T9 CARDIAC ABLATION GENERATORS (EQUIPPED WITH TEMPERATURE MONITORING) TO BE USED WITH THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER AND 2) THE EXTENSION CABLES (PREVIOUSLY APPROVED UNDER P960016/S016 FOR USE WITH THE IBI-1500T6) BE USED WITH THE IBI-1500 T9 RF GENERATOR.
P000049|S019|NMT MEDICAL, INC.|27 WORMWOOD ST.||BOSTON|MA|02210||Transcatheter septal occluder|CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD|MLV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2007|01/17/2008|||APPR|APPROVAL TO REMOVE THE MULLINS BURST TEST REQUIREMENT FOR THE DEVICE.
P030017|S026|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2007|06/23/2008|||APPR|APPROVAL FOR A CHANGE IN THE IPG RESISTANCE WELDING PROCESS OF THE ANTENNA WIRE.
P020026|S040|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2007|09/04/2007|||OK30|USE OF CYPHER OTW STENTS FOR ANALYTICAL TESTING PERFORMED PRIOR TO RELEASE INTO FINISHED GOODS INVENTORY AND FOR THE RESERVE SAMPLES FOR BOTH THE CYPHER SIROLIMUS-ELUTING CORONARY STENT RAPID EXCHANGE (RX) AND OVER-THE-WIRE (OTW) DELIVERY SYSTEMS.
P930016|S027|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/2007|11/09/2007|||APPR|APPROVAL FOR THE UPGRADE STAR SOFTWARE VERSION 5.21, STAR SOFTWARE VERSION 5.22 AND THE WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.671.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM AND ARE INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATIMILEUSIS (LASIK) TO ACHIEVE EYE OF PRESBYOPIC MYOPES: 1) 40 YEARS OR OLDER WHO MAY BENEFIT FROM INCREASED SPECTACLE INDEPENDENCE ACROSS A RANGE OF DISTANCES WITH USEFUL NEAR VISION; 2) WITH MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER UP TO -3.00 D, AND MINIMUM PRE-OPERATIVE MYOPIA IN THEIR NON-DOMINANT EYE AT LEAST AS GREAT AS THEIR TARGETED MYOPIA; 3) WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.50 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PREOPERATIVE EXAMINATION; AND 4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION EXPERIENCE.
P980040|S017|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2007|08/30/2007|||OK30|ADDITION OF AN ALTERNATE CLEANING SOLVENT, LIQUI-NOX, FOR THE 3-PIECE SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) MANUFACTURED AT THE AMO FACILITY IN ANASCO, PUERTO RICO.
P990080|S026|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2007|08/30/2007|||OK30|ADDITION OF AN ALTERNATE CLEANING SOLVENT, LIQUI-NOX, FOR THE 3-PIECE SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) MANUFACTURED AT THE AMO FACILITY IN ANASCO, PUERTO RICO.
P960028|S023|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2007|08/30/2007|||OK30|ADDITION OF AN ALTERNATE CLEANING SOLVENT, LIQUI-NOX, FOR THE 3-PIECE SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) MANUFACTURED AT THE AMO FACILITY IN ANASCO, PUERTO RICO.
P040043|S016|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2007|01/11/2008|||APPR|APPROVAL FOR THE OPTIONAL METHOD OF AIR STRIPING TO REMOVE THE WRAPPED GRAFT FROM THE MANDREL.
P010014|S016|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2007|09/12/2007|||APPR|APPROVAL FOR NEW FIXTURING TO BE USED DURING THE MANUFACTURING OF THE TIBIAL COMPONENTS OF THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM TO PREVENT COMPONENTS BEING MIS-MARKED.
P040043|S017|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2007|02/25/2008|||APPR|APPROVAL FOR THE MODIFICATIONS TO MANUFACTURING TOOLS AND THE CRUSH/TRANSFER LOADING PROCESS.
P030054|S063|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2007|03/17/2008|||APPR|APPROVAL FOR MERLIN@HOME DM EX 1200 TRANSMITTER WITH SOFTWARE EX 2000.
P030054|S064|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/13/2007|10/05/2007|||APPR|APPROVAL FOR SEVERAL SOFTWARE CHANGES FOR VERSION 7.0.74 FOR THE FIRMWARE AND FOR VERSION 6.3.1 FOR THE MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P910023|S150|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD'S|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2007|03/17/2008|||APPR|APPROVAL FOR MERLIN@HOME DM EX 1200 TRANSMITTER WITH SOFTWARE EX 2000.
P940019|S021|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ILIAC ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/2007|10/05/2007|||APPR|APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE.
P980016|S105|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2007|09/12/2007|||OK30|CHANGE IN THE VENDOR WHO PERFORMS THE PLASMA CLEANING PROCESS FOR THE PATIENT ALERT FLEX CIRCUIT.
P010031|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2007|09/12/2007|||OK30|CHANGE IN THE VENDOR WHO PERFORMS THE PLASMA CLEANING PROCESS FOR THE PATIENT ALERT FLEX CIRCUIT.
P980016|S106|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO FAMILY OF DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2007|09/12/2007|||OK30|REWORK PROCESS FOR A COMPONENT DURING THE MANUFACTURING PROCESS.
P010031|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-DS)|NIK|CV|30-Day Notice||N|08/13/2007|09/12/2007|||OK30|REWORK PROCESS FOR A COMPONENT DURING THE MANUFACTURING PROCESS.
P910023|S151|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/13/2007|10/05/2007|||APPR|APPROVAL FOR SEVERAL SOFTWARE CHANGES FOR VERSION 7.0.74 FOR THE FIRMWARE AND FOR VERSION 6.3.1 FOR THE MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P050023|S007|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIOMESSENGER (CM LLT, CM T LINE AND CM II)|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2007|11/09/2007|||APPR|APPROVAL FOR SOFTWARE, HARDWARE, PACKAGING AND LABELING MODIFICATIONS TO THE DEVICES.
P000009|S023|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIOMESSENGER TLINE|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2007|11/09/2007|||APPR|APPROVAL FOR SOFTWARE, HARDWARE, PACKAGING AND LABELING MODIFICATIONS TO THE DEVICES.
P950037|S054|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CARDIOMESSENGER II|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2007|11/09/2007|||APPR|APPROVAL FOR SOFTWARE, HARDWARE, PACKAGING AND LABELING MODIFICATIONS TO THE DEVICES.
P020001|S002|NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|STAN S31 FETAL HEART MONITOR|HEO|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|08/13/2007|09/26/2007|||APPR|APPROVAL FOR A CHANGE TO THE LCD PANEL MODEL, POWER SUPPLY UNIT, AND ADDITION OF AN INTERNAL FAN.  THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.  THE DEVICE IS INTENDED FOR USE IN PATIENTS WITH: 1) PLANNED VAGINAL DELIVERY; 2) >36 COMPLETED WEEKS GESTATION; 3) SINGLETON FETUS; 4) VERTEX PRESENTATION; AND 5) RUPTURED AMNIOTIC MEMBRANES.
P810002|S062|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2007|06/24/2008|||APPR|APPROVAL FOR MODIFYING THE SETTINGS OF THE PROCESS INPUT PARAMETERS FOR THE PYROLYTIC CARBON COATING PROCESS.
P000021|S010|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|08/14/2007|09/14/2007|||APPR|APPROVAL FOR THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION EXL CLINICAL CHEMISTRY SYSTEM.
P020027|S006|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|08/14/2007|09/14/2007|||APPR|APPROVAL FOR THE DIMENSION FPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION EXL CLINICAL CHEMISTRY SYSTEM.
P890003|S125|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK PROGRAMMER, MODEL 2090|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/14/2007|10/04/2007|||APPR|APPROVAL FOR SOFTWARE AND RAM-WARE MAINTENANCE UPDATES AS WELL AS ASSOCIATED REFERENCE AND IMPLANT MANUAL UPDATES.
P010031|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC SENTRY & MAXIMO USED WITH SOFTWARE APPLICATION, MODELS 7297 AND 7299|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/14/2007|10/04/2007|||APPR|APPROVAL FOR SOFTWARE AND RAM-WARE MAINTENANCE UPDATES AS WELL AS ASSOCIATED REFERENCE AND IMPLANT MANUAL UPDATES.
P970003|S087|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice||N|08/17/2007|09/04/2007|||OK30|ADDITION OF A NEW MODEL PACKAGING SYSTEM FOR THE DEVICE.
P980006|S011|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2007|09/19/2007|||OK30|CHANGE TO THE RAW MATERIAL SPECIFICATION FOR ONE OF THE COMPONENTS IN THE POLYMER FORMULATION FOR THE CONTACT LENS MATERIAL BALAFILCON A.
P810046|S223|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER RX CORONARY DILATATION CATHETER|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2007|09/19/2007|||OK30|MODIFICATION OF THE CUTTING PROCESS FOR NECKED TUNGSTEN TUBING FROM A MANUAL TO AN AUTOMATED PROCESS.
P050012|S012|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN SYSTEM|MDS|CH|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2007|10/22/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT DEXCOM, INC. IN SAN DIEGO, CALIFORNIA.
P860004|S091|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED ISOMED IMPLANTABLE INFUSION PUMPS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/20/2007|12/19/2007|||APPR|APPROVAL FOR PROPOSED LABELING CHANGES THAT ADDRESS INFLAMMATORY MASS FORMATION.
P990034|S010|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED ISOMED IMPLANTABLE INFUSION PUMPS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/20/2007|12/19/2007|||APPR|APPROVAL FOR PROPOSED LABELING CHANGES THAT ADDRESS INFLAMMATORY MASS FORMATION.
P060017|S001|JANSSEN DIAGNOSTICS|700 US HIGHWAY RTE 202 SOUTH||RARITAN|NJ|08869||Rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection|GENESEARCH BREAST LYMPH NODE|OCB|PA|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/15/2007|10/23/2007|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY.
P040024|S012|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/21/2007|04/21/2008|||APPR|APPROVAL FOR REVISION OF THE RESTYLANE PRODUCT LABEL TO INCLUDE THE RESULTS OF THE POST APPROVAL STUDY.
P810046|S224|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER OTW CORONARY DILATATION CATHETER|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2007|09/19/2007|||OK30|MODIFICATION OF THE MANUFACTURING TOOLS AND IN-PROCESS PARAMETERS USED DURING OUTER MEMBRANE NECKING AND PROXIMAL BALLOON SEALING.
P020026|S041|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2007|09/21/2007|||OK30|ELIMINATION OF VISUAL INSPECTIONS FOR LOOSE FIBERS INSIDE THE BALLOON THAT ARE CONDUCTED DURING THE CRIMP AND PACK MANUFACTURING PROCESS.
P040050|S002|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2007|10/03/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT UROPLASTY, INC., MINNETONKA, MINNESOTA.
P010012|S154|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/2007|02/15/2008|||APPR|APPROVAL FOR THE LIVIAN CRT-D DEVICES WITH CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2945, VERSION 1.01.
P950022|S041|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/22/2007|10/16/2007|||APPR|APPROVAL TO MODIFY THE SHOCK COIL ON THE RIATA ST OPTIM AND RIATA STS OPTIM LEADS AND TO ADD TWO NEW PASSIVE LEAD MODELS.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA ST OPTIM LEAD MODELS 7020, 7021, 7022, 7030, 7031, 7070 AND 7071 AND RIATA STS OPTIM LEAD MODELS 7120, 7121,7122, 7130, 7131, 7170 AND 7171 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS (REFER TO THE APPLICABLE DEFIBRILLATOR MANUL FOR SYSTEM INDICATIONS).  THEY PROVIDE PACING AND SENSING AND DELIVER CARDIOVERSION/ DEFIBRILLATION THERAPY TO THE HEART.
P060002|S001|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/22/2007|03/13/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P980016|S107|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2007|09/21/2007|||OK30|MODIFICATIONS TO THE HYBRID TESTS USED ON MULTIPLE ICDS AND CRT DEVICES.
P010031|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO CARDIAC RESYNCHRONIZATION THERAPY DEVICES (CRT-DS)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2007|09/21/2007|||OK30|MODIFICATIONS TO THE HYBRID TESTS USED ON MULTIPLE ICDS AND CRT DEVICES.
P010014|S017|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE|NRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/22/2007|02/20/2008|||APPR|APPROVAL FOR A PRODUCT LINE EXTENSION TO INCLUDE A NEW SERIES OF FEMORAL COMPONENTS DESIGNED TO ADD AN ADDITIONAL FIXATION PEG AND EXTEND THE ARTICULAR SURFACE 20 DEGREES ANTERIORLY.
P990056|S007|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA  IMMUNOASSAY AND ELECYS TOTAL PSA CALSET|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/2007|11/18/2008|||APPR|APPROVAL FOR EXTENSION OF THE ELECSYS TOTAL PSA AND CALSET II ONTO THE UPDATED MODEL OF THE ELECSYS 2010 ANALYZER, COBAS E 411 ANALYZER.
P960040|S147|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2007|02/13/2008|||APPR|APPROVAL FOR THE CONFIENT ICD DEVICES WITH CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2888, VERSION 1.07.
P890003|S126|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/2007|09/11/2007|||APPR|APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
P900061|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/2007|09/11/2007|||APPR|APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
P980016|S108|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/2007|09/11/2007|||APPR|APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
P980035|S076|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/2007|09/11/2007|||APPR|APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
P010031|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILY & CONCERTO CRT-ICDS|NIK|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/2007|09/11/2007|||APPR|APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
P010012|S155|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRACK CRT SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2007|12/20/2007|||APPR|APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
P030005|S046|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR CRT-P SYSTEM|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2007|12/20/2007|||APPR|APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
P040016|S026|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE MR & OTW CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2007|12/04/2008|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLING PERFORMED BY THE SUPPLIER FOR MEASURING THE COATING THICKNESS OF THE HYPOTUBE COMPONENT.
P030025|S049|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2007|12/04/2008|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLING PERFORMED BY THE SUPPLIER FOR MEASURING THE COATING THICKNESS OF THE HYPOTUBE COMPONENT.
P020009|S040|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2007|12/04/2008|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLING PERFORMED BY THE SUPPLIER FOR MEASURING THE COATING THICKNESS OF THE HYPOTUBE COMPONENT.
P860019|S221|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2007|12/04/2008|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLING PERFORMED BY THE SUPPLIER FOR MEASURING THE COATING THICKNESS OF THE HYPOTUBE COMPONENT.
P910023|S152|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICD'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2007|09/21/2007|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR A COMPONENT USED ON THE HYBRID.
P030054|S065|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY OF CRT-D'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2007|09/21/2007|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR A COMPONENT USED ON THE HYBRID.
P910077|S076|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI AICD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2007|12/20/2007|||APPR|APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
P840068|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA/VISTA AND VIGOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2007|12/20/2007|||APPR|APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
P040027|S006|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|CHANGE IN THE TESTING PROCESS FOR THE NITINOL WIRE.
P940031|S061|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSAR/PULSAR MAX/ DISCOVERY/MERIDIAN|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2007|12/20/2007|||APPR|APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
P960040|S148|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV AICD SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2007|12/20/2007|||APPR|APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
P970051|S041|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|CHANGE IN BIOCOMPATIBILITY INFORMATION FOR THE COIL SPACER (MATERIAL SPECIFICATION CHANGE).
P970051|S042|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|ASSEMBLY CHANGES FOR STRENGTHENING CABLE CONDUCTOR CONNECTIONS.
P970051|S043|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|CHANGE IN THE POST-WASH DRYING TEMPERATURE FOR THE HYBRID ASSEMBLY.
P900033|S017|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|REPLACEMENT OF A MANUFACTURING VESSEL.
P040044|S002|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)||N|08/24/2007|09/20/2007|||APPR|APPROVAL FOR ADDITIONAL WARNINGS REGARDING DEVICE USE AT PARTICULAR PUNCTURE SITE LOCATIONS IN THE INSTRUCTIONS FOR USE (IFU) FOR THE DEVICE.
P020036|S008|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|CORDIS S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|08/24/2007|09/20/2007|||APPR|APPROVAL FOR THE ESTABLISHMENT OF AN ADDITIONAL SPECIFICATION FOR A BISMUTH SUBCARBONATE BLEND RAW MATERIAL.
P020052|S003|St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER|MTE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|IMPLEMENTATION OF NEWLY QUALIFIED ELECTRODE RING SWAGING EQUIPMENT AND SWAGING DIES, FOR SWAGING ELECTRODE RINGS ONTO CATHETER SHAFT, AND PERFORMANCE OF PREVENTIVE CLEANING FOR SWAGING DIES.
P970051|S044|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|CHANGE IN THE ASSEMBLY AND STYLET INSERTION PROCESSES.
P970003|S088|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY PULSE & PULSE DUO GENERATORS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|ADDITIONAL QUALITY CONTROL TEST.
P020052|S004|St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER|MTE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|MODIFICATION OF THE METHOD OF TRAY CLEANING USED IN PACKAGING OF THE DEVICE.
P960053|S004|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, finger, constrained, metal/polymer|SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS|KWG|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/28/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PROFESSIONAL CONTRACT STERILIZATION, TAUNTON, MASSACHUSETTS.
P040025|S005|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|COOL CAP SYSTEM|MXM|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2007|09/21/2007|||OK30|REPLACING A MECHANICAL TEST GAUGE WITH AN ELECTRONIC GAUGE AND THE RELEASE OF AN ACCEPTANCE TEST PROCEDURE FOR THE PERIODIC VERIFICATION OF ALL TEST FIXTURES.
P960016|S020|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|SAFIRE BIDIRECTIONAL ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/03/2007|12/19/2007|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE OUTER SHELL OF THE UPPER AND LOWER HANDLE COMPONENTS.
P000025|S027|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/27/2007|09/25/2007|||APPR|APPROVAL FOR CHANGES TO THE MICROPHONE TEST DEVICE (MTD) USERS MANUAL.
P030047|S005|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL & RX NITINOL & PRO RX NITINOL STENT SYSTEM|NIM|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2007|09/20/2007|||APPR|APPROVAL FOR THE ESTABLISHMENT OF AN ADDITIONAL SPECIFICATION FOR A BISMUTH SUBCARBONATE BLEND RAW MATERIAL.
P030002|S012|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|NAA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2007|09/26/2007|||OK30|ADDITION OF A CHANGE IN THE RAW MATERIALS MIXING METHOD.
P020056|S004|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2007|03/20/2008|||APPR|APPROVAL OF THE ADDITION OF THE SHELL FABRICATION/DIPPING PRODUCTION TO THE MANUFACTURING SITE LOCATED IN HEREDIA COSTA RICA.
P980049|S028|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/29/2007|11/13/2007|||APPR|APPROVAL FOR THE SMARTVIEW 2.02 UG2 SOFTWARE AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS (MANAGER, OVATION) AND TO INCLUDE A DOWNLOADABLE RAM PATCH (SYMPHONY/ RHAPSODY).
P950029|S031|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|ALL RATE RESPONSIVE IMPLANTABLE PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/29/2007|11/13/2007|||APPR|APPROVAL FOR THE SMARTVIEW 2.02 UG2 SOFTWARE AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS (MANAGER, OVATION) AND TO INCLUDE A DOWNLOADABLE RAM PATCH (SYMPHONY/ RHAPSODY).
P900022|S009|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|ALL NON-RATE RESPONSIVE PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/29/2007|11/13/2007|||APPR|APPROVAL FOR THE SMARTVIEW 2.02 UG2 SOFTWARE AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS (MANAGER, OVATION) AND TO INCLUDE A DOWNLOADABLE RAM PATCH (SYMPHONY/ RHAPSODY).
P050038|S003|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2007|09/27/2007|||OK30|CHANGE IN THE FREQUENCY OF ENDOTOXIN TESTING ON A BULK INCOMING RAW MATERIAL.
P910023|S153|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2007|09/28/2007|||OK30|ALTERNATE PROCESS TO REMOVE CLEANING AND FINISHING RESIDUE FROM DEVICES FOLLOWING SODA BLAST AND GRIT BLAST PROCESS.
P030054|S066|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT-D'S|NIK|CV|30-Day Notice||N|08/30/2007|09/28/2007|||OK30|ALTERNATE PROCESS TO REMOVE CLEANING AND FINISHING RESIDUE FROM DEVICES FOLLOWING SODA BLAST AND GRIT BLAST PROCESS.
P860004|S092|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSION PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2007|11/21/2007|||APPR|APPROVAL FOR SOFTWARE UPDATES MADE TO N?VISION PROGRAMMING SYSTEM MODEL 8840.
P840001|S098|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|N¿VISION PROGRAMMING SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2007|11/05/2008|||APPR|APPROVAL FOR SOFTWARE UPDATES MADE TO N¿VISION PROGRAMMING SYSTEM MODEL 8840.
P960009|S041|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|N¿VISION PROGRAMMING SYSTEM|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2007|11/05/2008|||APPR|APPROVAL FOR SOFTWARE UPDATES MADE TO NVISION PROGRAMMING SYSTEM MODEL 8840.
P970004|S041|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FOR URINARY CONTROL|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2007|11/07/2007|||APPR|APPROVAL OR SOFTWARE CHANGES TO THE MODEL 8840 N?VISION PROGRAMMING SYSTEM.
P010012|S156|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTRAK CD/EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2007|09/28/2007|||OK30|AUTOMATION OF AN ADHESIVE APPLICATION PROCESS.
P960040|S149|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VR (VENTAK PRIZM)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2007|09/28/2007|||OK30|AUTOMATION OF AN ADHESIVE APPLICATION PROCESS.
P050024|S001|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CRYOCOR CRYOABLATION SYSTEM|OAD|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/31/2007|03/13/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P050016|S002|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2007|11/02/2007|||APPR|APPROVAL FOR THE ADDITION OF INTERMEDIATE SIZES FOR BOTH THE FEMORAL HEAD (42MM, 46MM, 50MM, AND 54MM) AND THE CORRESPONDING ACETABULAR CUP COMPONENTS WITHIN THE PRODUCT LINE FOR THE CORMET HIP RESURFACING SYSTEM AND REVISIONS TO THE CORMET HIP RESURFACING LABELING TO REFLECT THESE ADDITIONAL INTERMEDIATE-SIZED COMPONENTS.  THE DEVICE IS INDICATED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING CONDITIONS:  1) NON-INFLAMMATORY DEGENERATIVE ARTHRITIS SUCH AS OSTEOARTHRITIS AND AVASCULAR NECROSIS; 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.
P990012|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2007|11/13/2008|||APPR|APPROVAL FOR THE EXTENSION OF THE ELECSYS HBSAG TEST SYSTEM AND THE ELECSYS ANTI-HBS TEST SYSTEM ONTO THE UPDATED MODEL OF THE ELECSYS 2010 ANALYZER, KNOWN AS THE COBAS E 411 ANALYZER.
P010054|S007|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2007|11/13/2008|||APPR|APPROVAL FOR THE EXTENSION OF THE ELECSYS HBSAG TEST SYSTEM AND THE ELECSYS ANTI-HBS TEST SYSTEM ONTO THE UPDATED MODEL OF THE ELECSYS 2010 ANALYZER, KNOWN AS THE COBAS E 411 ANALYZER.
P910077|S077|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/2007|11/06/2007|||APPR|APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482), VERSION 2.0 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.3.0 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS, MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
P010012|S157|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL 3 RF FAMILIES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2007|11/06/2007|||APPR|APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482), VERSION 2.0 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.3.0 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS, MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
P960040|S150|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM & VITALITY FAMILIES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2007|11/06/2007|||APPR|APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482), VERSION 2.0 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.3.0 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS, MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
P810006|S029|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2007|10/03/2007|||OK30|UPGRADE OF PRODUCTION PROCESSING EQUIPMENT AND CHANGING A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P850010|S026|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2007|10/03/2007|||OK30|UPGRADE OF PRODUCTION PROCESSING EQUIPMENT AND CHANGING A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P840062|S015|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2007|10/03/2007|||OK30|UPGRADE OF PRODUCTION PROCESSING EQUIPMENT AND CHANGING A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P910023|S154|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PROMOTE CRT-D SYSTEM|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/2007|01/13/2009|||APPR|APPROVAL FOR THE ST. JUDE MEDICAL SJ4 QUADRIPOLAR DEFIBRILLATION SYSTEMCONSISTING OF DEVICE MODELS ATLAS II+HF V366Q AND PROMOTE 3107-36Q; LEAD MODELS RIATA STOPTIM 7020Q, 7021Q, 7022Q, AND RIATA STS OPTIM 7120Q, 7121Q, 7122Q; AND PROGRAMMER MODELS SJM 3510 AND MERLIN 3650.
P030054|S067|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS II + HF CRT-D SYSTEM|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/2007|01/13/2009|||APPR|APPROVAL FOR THE ST. JUDE MEDICAL SJ4 QUADRIPOLAR DEFIBRILLATION SYSTEMCONSISTING OF DEVICE MODELS ATLAS II+HF V366Q AND PROMOTE 3107-36Q; LEAD MODELS RIATA STOPTIM 7020Q, 7021Q, 7022Q, AND RIATA STS OPTIM 7120Q, 7121Q, 7122Q; AND PROGRAMMER MODELS SJM 3510 AND MERLIN 3650.
P950022|S042|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|RIATA ST OPTIM AND RIATA STS OPTIM|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/2007|01/13/2009|||APPR|APPROVAL FOR THE ST. JUDE MEDICAL SJ4 QUADRIPOLAR DEFIBRILLATION SYSTEMCONSISTING OF DEVICE MODELS ATLAS II+HF V366Q AND PROMOTE 3107-36Q; LEAD MODELS RIATA STOPTIM 7020Q, 7021Q, 7022Q, AND RIATA STS OPTIM 7120Q, 7121Q, 7122Q; AND PROGRAMMER MODELS SJM 3510 AND MERLIN 3650.
P050033|S003|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|COSMETIC TISSUE AUGMENTATION PRODUCT (CTA)|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2007|11/19/2007|||APPR|APPROVAL FOR MODIFICATIONS TO MANUFACTURING EQUIPMENT AND PROCEDURES.
P020026|S042|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|09/06/2007|10/16/2007|||APPR|APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE.
P060018|S001|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE CERVICAL DISC|MJO|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/2007|09/18/2007|||APPR|APPROVAL FOR CHANGES TO THE SURGICAL TECHNIQUE MANUAL (I.E., MODIFICATION OF FIGURE 8 AND THE ADDITION OF A CAUTIONARY NOTE).
P020001|S004|NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|NEOVENTA'S STAN S31 FETAL HEART MONITOR|HEO|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/2007|04/11/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE STAN FETAL HEART RATE CLASSIFICATION AND THE STAN SIMPLIFIED CLINICAL GUIDELINES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STAN S31 FETAL HEART MONITOR AND IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.  THE DEVICE IS INTENDED FOR USE IN PATIENTS WITH: 1) PLANNED VAGINAL DELIVERY; 2) >36 COMPLETED WEEKS GESTATION; 3) SINGLETON FETUS; 4) VERTEX PRESENTATION; AND 5) RUPTURED AMNIOTIC MEMBRANES.
P980041|S010|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/2007|11/27/2007|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED IN THE WASH BUFFER.
P910077|S078|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ZOOM LATITUDE PROGRAMMING SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/2007|10/18/2007|||APPR|APPROVAL FOR LEAKAGE CURRENT RE-CLASSIFICATION FROM CF TO BF AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.
P970003|S089|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/10/2007|10/11/2007|||APPR|APPROVAL FOR THE ADDITION OF INSTRUCTIONS TO THE TROUBLESHOOTING SECTION IN THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.1 AND MINOR CORRESPONDING CHANGES TO THE HANDHELD COMPUTER CONNECTION INSTRUCTIONS (HP JORNADA, DELL AXIM X5 AND X50).
P020047|S010|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION CORONARY STENT SYSTEM AND MULTI-LINK MINI VISION CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2007|10/26/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR, GALWAY, IRELAND.
P000010|S012|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2007|08/26/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMERVILLE, NEW JERSEY FOR BULK MANUFACTURING AND FILLING OPERATIONS.
P000012|S016|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2007|08/26/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMERVILLE, NEW JERSEY FOR BULK MANUFACTURING AND FILLING OPERATIONS.
P040027|S007|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROTHESIS|MIR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/2007|04/11/2008|||APPR|APPROVAL FOR MRI CONDITIONAL LABELING FOR 1.5 AND 3.0 TESLA MR SYSTEMS.
P020004|S028|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/2007|04/11/2008|||APPR|APPROVAL FOR MRI CONDITIONAL LABELING FOR 1.5 AND 3.0 TESLA MR SYSTEMS.
P040043|S018|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/2007|04/11/2008|||APPR|APPROVAL FOR MRI CONDITIONAL LABELING FOR 1.5 AND 3.0 TESLA MR SYSTEMS.
P920015|S038|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2007|02/06/2008|||APPR|APPROVAL FOR CHANGING THE MOLDING VENDOR AND MOLDING PROCESS PARAMETERS FOR THE IS-1 CONNECTOR SLEEVE COMPONENT FOR SPRINT LEAD MODELS 6930, 6931, 6945, 6947, 6948, 6949, AND 6944.
P910023|S155|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2007|10/12/2007|||OK30|ALTERNATE SUPPLIER FOR THE ISOLATION TRANSFORMER MODULE (ITM) USED ON THE HIGH VOLTAGE ASSEMBLY OF THE CURRENT ICDS AND PROMOTE CRT-DS.
P030054|S068|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2007|10/12/2007|||OK30|ALTERNATE SUPPLIER FOR THE ISOLATION TRANSFORMER MODULE (ITM) USED ON THE HIGH VOLTAGE ASSEMBLY OF THE CURRENT ICDS AND PROMOTE CRT-DS.
P010019|S007|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2007|02/08/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CIBA VISION JOHOR SDN. BHD., JOHOR MALAYSIA, FOR THE FINISHING (BACK-END MANUFACTURING) OF THE DEVICE.
P040024|S013|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2007|10/12/2007|||OK30|CHANGE TO THE METHOD FOR COUNTING SYRINGES DURING THE ASSEMBLY PROCESS FROM MANUAL TO AN AUTOMATED PROCESS.
P840024|S087|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2007|10/16/2007|||APPR|APPROVAL FOR MODIFICATIONS TO CUSTOM SOUND PROGRAMMING SOFTWARE TO PROVIDE RECEIPTS OF PREVIOUS GENERATION NUCLEUS 22 COCHLEAR IMPLANTS WITH ACCESS TO THE NUCLEUS FREEDOM SPEECH PROCESSOR.
P890027|S056|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2007|10/16/2007|||APPR|APPROVAL FOR MODIFICATIONS TO CUSTOM SOUND PROGRAMMING SOFTWARE TO PROVIDE RECEIPTS OF PREVIOUS GENERATION NUCLEUS 22 COCHLEAR IMPLANTS WITH ACCESS TO THE NUCLEUS FREEDOM SPEECH PROCESSOR.
P050033|S004|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|ELEVESS|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/2007|01/24/2008|||APPR|APPROVAL FOR AN INCREASE IN THE ELEVESS EXPIRATION DATE FROM 9 TO 18 MONTHS.
P970004|S042|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF NEUROSTIMULATOR|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|01/11/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHYLENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P840001|S099|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL3,SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR INPLANTABLE NEUROSTIMULATOR|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|01/11/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHYLENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P960009|S042|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA THERAPY FOR DEEP BRAIN STIMULATION|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/2007|10/17/2007|||APPR|APPROVAL FOR TE ADDITION OF A PRECAUTION TO PATIENT MANUALS OF THE MODEL 7436 AND MODEL 7438 THERAPY CONTROLLERS.
P860004|S093|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PUMP|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|01/11/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHYLENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P960009|S043|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|KINETRA & SOLETRA FAMILY OF NEUROSTIMULATOR|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|01/11/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHYLENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P980016|S109|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|02/08/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHY-LENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P010031|S079|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF ICD & CONCERTO ICD|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|02/08/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHY-LENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P980050|S029|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT ICD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|02/08/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHY-LENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P010015|S032|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III CRT-P|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|02/08/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHY-LENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P980035|S077|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|AT 500 IPG & ENRHYTHM IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2007|02/08/2008|||APPR|APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHY-LENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS.
P970004|S043|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/2007|10/15/2007|||APPR|APPROVAL FOR THE ADDITION OF A PRECAUTION AND OTHER MINOR MODIFICATIONS OF THE DEVICE LABELING.
P030031|S006|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER FOR TREATMENT OF TYPE I ATRIAL FLUTTER|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/17/2007|11/28/2007|||APPR|APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL STUDY PROTOCOL.
P790007|S020|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2007|10/18/2007|||OK30|ADDITIONAL SUPPLIERS FOR PORCINE AORTIC HEART VALVES.
P980043|S013|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2007|10/18/2007|||OK30|ADDITIONAL SUPPLIERS FOR PORCINE AORTIC HEART VALVES.
P990064|S020|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2007|10/18/2007|||OK30|ADDITIONAL SUPPLIERS FOR PORCINE AORTIC HEART VALVES.
P970031|S020|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2007|10/18/2007|||OK30|ADDITIONAL SUPPLIERS FOR PORCINE AORTIC HEART VALVES.
P910077|S079|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 3120 ZOOM PROGRAMMER SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2007|10/19/2007|||OK30|MODIFICATIONS TO THE TEST SOFTWARE FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER.
P040042|S011|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE TX CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2007|10/19/2007|||OK30|REROUTING OF ONE SET OF THERMOCOUPLE WIRES AND A MODIFICATION TO THE ACTIVATION WIRE.
P020004|S029|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|09/20/2007|10/19/2007|||OK30|ALTERNATE SITE FOR PERFORMING THE VERIFICATION OF THE GRAFT ATTACH PROCESS.
P950022|S043|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2007|10/19/2007|||OK30|ALTERNATE SUPPLIER FOR ETFE COATED CABLES.
P030054|S069|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF CRT-D FAMILY OF DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2007|10/19/2007|||OK30|MINOR CHANGES TO THE AUTOMATED TEST SOFTWARE.
P910023|S156|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2007|10/19/2007|||OK30|MINOR CHANGES TO THE AUTOMATED TEST SOFTWARE.
P060010|S001|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/20/2007|02/12/2008|||APPR|APPROVAL FOR THE STANDARD TETHER (ST) LENGTH MODIFICATION TO SIZE 7-9 SPANNER STENTS.
P050033|S005|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|ELEVESS|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/2007|10/03/2007|||APPR|APPROVAL FOR THE CHANGE IN PRODUCT TRADE NAME.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELEVESS AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
P030054|S070|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2007|11/06/2007|||APPR|APPROVAL FOR MODEL 3330 VERSION 6.3.1 SOFTWARE FOR MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030035|S034|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2007|11/06/2007|||APPR|APPROVAL FOR MODEL 3330 VERSION 6.3.1 SOFTWARE FOR MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880006|S053|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2007|11/06/2007|||APPR|APPROVAL FOR MODEL 3330 VERSION 6.3.1 SOFTWARE FOR MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880086|S151|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2007|11/06/2007|||APPR|APPROVAL FOR MODEL 3330 VERSION 6.3.1 SOFTWARE FOR MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P910023|S157|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2007|11/06/2007|||APPR|APPROVAL FOR MODEL 3330 VERSION 6.3.1 SOFTWARE FOR MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970013|S020|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS/PACEMAKER PROGRAMMER|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2007|11/06/2007|||APPR|APPROVAL FOR MODEL 3330 VERSION 6.3.1 SOFTWARE FOR MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970020|S049|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ZETA RX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|REPLACING BONDING EQUIPMENT WITH A NEW HEAT BONDER AT THREE BONDING PROCESSES OF THE PROXIMAL AND DISTAL SHAFT SUBASSEMBLY.
P030004|S003|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM|MFE|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/2007|10/09/2007|||APPR|APPROVAL FOR REVISION OF THE PRODUCT LABEL TO INCLUDE A BOXED WARNING REGARDING THE EMISSION OF SPARKS THAT OCCURS WHEN ONYX-EMBOLIZED TISSUE IS SURGICALLY RESECTED WITH MONOPOLAR ELECTROCAUTERY DEVICES.
P000053|S011|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|CHANGE IN THE SAMPLING PLAN FOR INCOMING INSPECTION OF TUBING CONNECTORS IN THE ACCESSORY KIT.
P010020|S007|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|CHANGE IN THE SAMPLING PLAN FOR INCOMING INSPECTION OF TUBING CONNECTORS IN THE ACCESSORY KIT.
P890003|S127|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|11/09/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS-PENANG, PENANG, MALAYSIA.
P970003|S090|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/24/2007|12/20/2007|||APPR|APPROVAL FOR REVISIONS TO THE POST-APPROVAL STUDY.
P980016|S110|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS, MAXIMO AND EN TRUST DEVICE|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|11/09/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS-PENANG, PENANG, MALAYSIA.
P010031|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC MARQUIS, INSYNC SENTRY, AND INSYNC MAXIMO FAMILIES|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|11/09/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS-PENANG, PENANG, MALAYSIA.
P000040|S012|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HTA SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|09/25/2007|11/02/2007|||APPR|APPROVAL FOR A CHANGE TO THE INTERFACE BETWEEN THE THERMISTOR CONDITIONING BOARD, MOTHER BOARD, AND TEMPERATURE CONTROLLER BOARD TO IMPROVE CONNECTIONS AND MITIGATE SIGNAL LOSS.
P980040|S018|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR ACRYLIC IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|INCREASE IN THE FREQUENCY OF MICROBIOLOGICAL MONITORING FOR THE WATER SYSTEM IN THE ADVANCED MEDICAL OPTICS (AMO) ANASCO, PUERTO RICO FACILITY.
P960028|S024|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY MULTIFOCAL IOLS & REZOOM MULTIFOCAL IOLS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|INCREASE IN THE FREQUENCY OF MICROBIOLOGICAL MONITORING FOR THE WATER SYSTEM IN THE ADVANCED MEDICAL OPTICS (AMO) ANASCO, PUERTO RICO FACILITY.
P990080|S027|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|INCREASE IN THE FREQUENCY OF MICROBIOLOGICAL MONITORING FOR THE WATER SYSTEM IN THE ADVANCED MEDICAL OPTICS (AMO) ANASCO, PUERTO RICO FACILITY.
P880081|S034|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SILICONE IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|INCREASE IN THE FREQUENCY OF MICROBIOLOGICAL MONITORING FOR THE WATER SYSTEM IN THE ADVANCED MEDICAL OPTICS (AMO) ANASCO, PUERTO RICO FACILITY.
P030005|S047|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2007|10/26/2007|||OK30|ADDITION OF A SECOND IN-LINE MEDICAL ADHESIVE CURE OVEN.
P960030|S017|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS DX FAMILY OF LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|REDUCTION IN THE FREQUENCY OF MONITORING FOR VARIOUS WATER SYSTEM TESTS.
P880086|S152|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PASSIVE PLUS DX FAMILY OF LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|REDUCTION IN THE FREQUENCY OF MONITORING FOR VARIOUS WATER SYSTEM TESTS.
P830045|S110|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS & 3510 PROGRAMMER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|REDUCTION IN THE FREQUENCY OF MONITORING FOR VARIOUS WATER SYSTEM TESTS.
P910023|S158|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|VARIOUS FAMILIES OF ICDS & MERLIN PROGRAMMER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2007|10/24/2007|||OK30|REDUCTION IN THE FREQUENCY OF MONITORING FOR VARIOUS WATER SYSTEM TESTS.
P970003|S091|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Other Report|N|09/27/2007|12/20/2007|||APPR|APPROVAL FOR REVISIONS TO THE POST-APPROVAL STUDY.
P050009|S004|Biomet, Inc.|P.O. Box 587||Warsaw|IN|46581|0587|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|C2A-TAPER ACETABULAR SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2007|04/17/2009|||APPR|APPROVAL FOR A CHANGE IN THE MATERIAL OF THE INNER POUCH WHICH HOLDS THE STERILE POROUS HIP CUPS, INCLUDING COMPONENTS OF THE DEVICE.
P000025|S028|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2007|10/24/2007|||OK30|ADDITION OF A CLEANROOM MODULE.
P050006|S004|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2007|02/13/2008|||APPR|APPROVAL FOR AN ALTERNATE SITE FOR COMPONENT ASSEMBLY.
P040012|S027|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|09/27/2007|02/21/2008|||APPR|APPROVAL FOR MODIFICATIONS OF THE DEVICE LABELING TO INCLUDE AN ADDITIONAL WARNING AND A SUMMARY OF THE CAPTURE POST-APPROVAL STUDY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RX ACCUYLINK CAROTID STENT SYSTEM AND, USED IN CONJUNCTION WITH ABBOTT VASCULAR X ACCUNET EMBOLIC PROTECTION SYSTEMS, IS INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE REVASCULARIZATION AND MEET THE FOLLOWING CRITERIA: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITH OUT NEUROLOGICAL SYMPTOMS AND >= 80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM; AND 2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION.
P980003|S020|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/27/2007|10/29/2007|||APPR|APPROVAL FOR INCORPORATION OF A WARNING AND EMC STATEMENT TO THE MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP) OPERATOR?S MANUAL.
P990020|S027|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STONE GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2007|10/26/2007|||OK30|USE (BY THE CURRENT SUPPLIER OF BIFURCATED GRAFT COMPONENTS) OF AN ALTERNATE SUPPLIER OF POLYESTER YARN FOR THE MANUFACTURE OF ALL ANEURX AAADVANTAGE BIFURCATED AND ILIAC LIMB SUBCOMPONENT CONFIGURATIONS.
P950005|S022|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/28/2007|11/28/2007|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE CATHETER.
P880086|S153|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY,INTEGRITY,VERITY,VICTORY & ZEPHYR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2007|10/26/2007|||OK30|ALTERNATE SUPPLIER OF XL SIZE CANS.
P030006|S016|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2007|10/24/2007|||OK30|CHANGES INTENDED TO REDUCE IN-PROCESS SCRAP OF THE CATHETER COMPONENT.
P000053|S012|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2007|11/13/2007|||OK30|CHANGES IN CLEANING PROCESSES TO REMOVE RESIDUAL MANUFACTURING MATERIALS.
P010012|S158|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRACK 2 FAMILY OF LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2007|11/21/2007|||OK30|ADDITION OF A NEW SUPPLIER FOR AN EXTRUSION PROCESS.
P810006|S030|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2007|11/23/2007|||OK30|MODIFICATION AND RE-QUALIFICATION OF AN EXISTING CLEAN ROOM USED TO MANUFACTURE COLLAGEN HEMOSTATIC AGENTS.
P850010|S027|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2007|11/23/2007|||OK30|MODIFICATION AND RE-QUALIFICATION OF AN EXISTING CLEAN ROOM USED TO MANUFACTURE COLLAGEN HEMOSTATIC AGENTS.
P840062|S016|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2007|11/23/2007|||OK30|MODIFICATION AND RE-QUALIFICATION OF AN EXISTING CLEAN ROOM USED TO MANUFACTURE COLLAGEN HEMOSTATIC AGENTS.
P900033|S018|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2007|11/23/2007|||OK30|MODIFICATION AND RE-QUALIFICATION OF AN EXISTING CLEAN ROOM USED TO MANUFACTURE COLLAGEN HEMOSTATIC AGENTS.
P880086|S154|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PASSIVE FIXATION FAMILY OF LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2007|10/31/2007|||OK30|CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.
P960013|S034|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|ACTIVE FIXATION FAMILY OF LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2007|10/31/2007|||OK30|CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.
P960030|S018|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|CARDIOVASCULAR PERMANENT PACEMAKERS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2007|10/31/2007|||OK30|CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.
P030035|S035|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|LEFT VENTRICULAR FAMILY OF LEADS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2007|10/31/2007|||OK30|CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.
P030054|S071|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|LEFT VENTRICULAR FAMILY OF LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2007|10/31/2007|||OK30|CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.
P950009|S008|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT GS IMAGING SYSTEM|MNM|PA|Panel Track|Change Design/Components/Specifications/Material|N|10/02/2007|12/03/2008|09M-0016|01/27/2009|APPR|APPROVAL FORTHE BD FOCALPOINT GS IMAGING SYSTEM. THIS DEVICE IS INDICATED TO ASSIST IN CERVICAL CANCERSCREENING OF BD SUREPATH PAP TEST SLIDES TO DETECT EVIDENCE OF SQUAMOUS CARCINOMA,ADENOCARCINOMA, AND THEIR USUAL PRECURSOR CONDITIONS. THESE SLIDES WILL BE RANKED ACCORDING TOTHE LIKELIHOOD OF ABNORMALITY, AND PROVIDE RELOCATION AND VISUAL REVIEW OF UP TO 10 FIELDS OF VIEW(FOVS) MOST LIKELY TO CONTAIN ABNORMAL CELLS. ADDITIONALLY, THE SYSTEM IDENTIFIES AT LEAST 15% OFALL SUCCESSFULLY PROCESSED SLIDES WITH THE BD FOCAL POINT SLIDE PROFILER* DIRECTED QCTECHNOLOGY FOR A DIRECTED QC RE-SCREEN. INTENDED USERS ARE TRAINED CYTOLOGY LABORATORYPERSONNEL OPERATING UNDER THE DIRECT SUPERVISION OF A QUALIFIED CYTOLOGY SUPERVISOR OR LABORATORYMANAGER/DIRECTOR.
P020047|S011|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION RX FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2007|10/29/2007|||OK30|CHANGE IN E-BEAM IRRADIATION EQUIPMENT.
P970020|S050|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK VISION RX ZETA CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2007|10/29/2007|||OK30|CHANGE IN E-BEAM IRRADIATION EQUIPMENT.
P880081|S035|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2007|11/19/2007|||OK30|USE OF AN ADDITIONAL STERILIZATION CHAMBER FOR ETHYLENE OXIDE (EO) STERILIZATION OF IOL?S RESULTING IN BETTER TEMPERATURE DISTRIBUTION, BETTER SPACE UTILIZATION, AND LOWER STERILIZATION COSTS THAN THE CURRENT CHAMBER.
P960028|S025|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|MULTIFOCAL SILICONE & MULTIFOCAL ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2007|11/19/2007|||OK30|USE OF AN ADDITIONAL STERILIZATION CHAMBER FOR ETHYLENE OXIDE (EO) STERILIZATION OF IOL?S RESULTING IN BETTER TEMPERATURE DISTRIBUTION, BETTER SPACE UTILIZATION, AND LOWER STERILIZATION COSTS THAN THE CURRENT CHAMBER.
P980040|S019|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRACULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2007|11/19/2007|||OK30|USE OF AN ADDITIONAL STERILIZATION CHAMBER FOR ETHYLENE OXIDE (EO) STERILIZATION OF IOL?S RESULTING IN BETTER TEMPERATURE DISTRIBUTION, BETTER SPACE UTILIZATION, AND LOWER STERILIZATION COSTS THAN THE CURRENT CHAMBER.
P990080|S028|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON & TECNIS UV-ABORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2007|11/19/2007|||OK30|USE OF AN ADDITIONAL STERILIZATION CHAMBER FOR ETHYLENE OXIDE (EO) STERILIZATION OF IOL?S RESULTING IN BETTER TEMPERATURE DISTRIBUTION, BETTER SPACE UTILIZATION, AND LOWER STERILIZATION COSTS THAN THE CURRENT CHAMBER.
P010032|S023|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON IPG NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/2007|03/28/2008|||APPR|APPROVAL FOR THE EONMINI IPG NEUROSTIMULATION SYSTEM (MODEL 3788), WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P030022|S008|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR SYSTEM|MRA|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/2007|02/18/2009|||APPR|APPROVAL FOR 1) THE ADDITION OF THE REFLECTION 3 (R3) CERAMIC (BIOLOX FORTE) LINERS (32MM ID, 36MM ID), WHICH FEATURE A FACTORY-ASSEMBLED TITANIUM ALLOY OUTER RING; THE MODIFIED ACETABULAR SHELL(I.E., R3 ACETABULAR SHELLS) TO ACCEPT THE MODIFIED CERAMIC LINERS; AND THE 36MM BIOLOX FORTE FEMORAL HEAD (+0, +4. +8); 2) AN ADDITIONAL MANUFACTURING SITE AT SMITH & NEPHEW ORTHOPAEDICS, TUTTLINGEN, GERMANY, FOR THEMANUFACTURING AND ASSEMBLY OF THE TITANIUM RING; AND 3) A STERILIZATION SITE FOR THE R3 CERAMIC LINERS WITH THE AFFIXED OUTER METAL RING AT BBF STERILIZATION SERVICES, GMBH, KERNEN, GERMANY.
P820060|S023|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT ARCHITECT AFP|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/2007|05/21/2008|||APPR|APPROVAL FOR: 1) CREATION OF AFP WHO PRIMARY CALIBRATORS AND CONTROLS; 2) ASSAY SOFTWARE CHANGES: A) VOLUME OF SAMPLE IN THE PIPETTING PROTOCOL; B) DILUTION OF SPECIMEN IN THE AUTOMATED DILUTION PROTOCOLS; AND C) DILUTION PARAMETERS; 3) MANUAL DILUENT CHANGE; AND 4) NEW CONTROL CONCENTRATIONS.
P860047|S020|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/2007|03/24/2008|||APPR|APPROVAL FOR A CHANGE TO THE PRIMARY CONTAINER OF OCUCOAT, PACKAGING AND METHOD OF STERILIZATION.
P030017|S028|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2007|11/21/2007|||OK30|CHANGE IN THE TECHNIQUE FOR VERIFYING CONTINUITY OF SCS LEADS.
P950005|S023|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS & EZ STEER FAMILIES OF CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2007|10/29/2007|||OK30|CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.
P990025|S014|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|QUIKSTAR FAMILY OF CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2007|10/29/2007|||OK30|CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.
P010068|S011|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR & EZ STEER FAMILIES OF CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2007|10/29/2007|||OK30|CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.
P030031|S007|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR & CELSIUS FAMILIES OF CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2007|10/29/2007|||OK30|CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.
P040036|S004|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR FAMILY OF CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2007|10/29/2007|||OK30|CHANGE TO THE ETHYLENE OXIDE STERILIZATION CYCLE PROCESS PARAMETERS.
P040044|S003|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2007|11/14/2007|||OK30|USE OF UV/ CYANOACRYLATE ADHESIVE FOR THE BALLOON PROXIMAL BOND AND USE OF BALLOON BLOWING AND TUBING NECKER MACHINES.
P840001|S100|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2007|02/29/2008|||APPR|APPROVAL FOR A NEW COMPONENT VENDOR FOR TWO INTEGRATED CIRCUITS (ICS) USED ON THE HYBRID IN THE RESTORE FAMILY OF DEVICES.
P960009|S044|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/08/2007|||OK30|CHANGE IN THE WORKSTATION USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P840001|S101|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3,RESTORE,RESTORE ADVANCED IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/08/2007|||OK30|CHANGE IN THE WORKSTATION USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P970004|S044|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/08/2007|||OK30|CHANGE IN THE WORKSTATION USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P020004|S030|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/09/2007|||OK30|EXPANSION OF THE ENVIRONMENT FOR THE STENT WINDING PROCESS.
P030009|S016|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice||N|10/09/2007|11/28/2007|||OK30|CHANGES TO THE INSPECTION PROCESS.
P000053|S013|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/05/2007|||OK30|IMPLEMENTATION OF ADDITIONAL PRESS EQUIPMENT FOR MOLD MANUFACTURING OF THE AMS 800 ARTIFICIAL URINARY SPHINCTER.
P010012|S159|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/14/2007|||OK30|ADDITION OF A NEW SUPPLIER FOR THIN FILM RESISTOR CHIPS.
P960040|S151|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, PRIZM AT & VITALITY FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/14/2007|||OK30|ADDITION OF A NEW SUPPLIER FOR THIN FILM RESISTOR CHIPS.
P990001|S032|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice||N|10/09/2007|11/09/2007|||OK30|CHANGE IN THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P010015|S033|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC CRT-P & INSYNC III CRT-P|LWP|CV|30-Day Notice||N|10/09/2007|11/09/2007|||OK30|CHANGE IN THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P970012|S029|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR IPG & KAPPA 400 SR IPG PACEMAKERS|NVZ|CV|30-Day Notice||N|10/09/2007|11/09/2007|||OK30|CHANGE IN THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P980035|S078|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice||N|10/09/2007|11/09/2007|||OK30|CHANGE IN THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P890003|S128|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/THERA-I PACEMAKERS|NVZ|CV|30-Day Notice||N|10/09/2007|11/09/2007|||OK30|CHANGE IN THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P030047|S007|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/08/2007|||OK30|CHANGE TO THE FILLER INGREDIENT IN THE UV ADHESIVE.
P970051|S045|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/09/2007|11/28/2007|||APPR|APPROVAL FOR THE MODIFICATIONS TO CUSTOM SOUND 2.0 PROGRAMMING SOFTWARE TO PROVIDE SEVERAL ENHANCEMENTS TO IMPROVE THE OVERALL USEABILITY FOR THE AUDIOLOGISTS, AND THE CAPABILITY OF LINKING A FREEDOM SPEECH PROCESSOR TO AN IMPLANT VIA AN IDENTIFIER TO MINIMIZE THE POSSIBILITY OF A RECIPIENT USING THE WRONG PROCESSOR.
P030031|S008|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR & CELSIUS CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2007|11/14/2007|||OK30|INCREASE IN THE STERILIZATION PALLET SIZE FROM A 6-PALLET LOAD TO A 10-PALLET LOAD.
P040036|S005|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2007|11/14/2007|||OK30|INCREASE IN THE STERILIZATION PALLET SIZE FROM A 6-PALLET LOAD TO A 10-PALLET LOAD.
P830063|S006|BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|PRISMAFLEX TPE 2000  SET|MDP|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/09/2007|06/17/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF 2000N TO PERMIT THE USE OF THE PLASMAFILTER WITH THE GAMBRO PRISMAFLEX SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISMAFLEX TPE 2000 SET AND IS INDICATED FOR THERAPEUTIC PLASMAPHERESIS.
P890003|S129|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS, CARELINK PROGRAMMER MODEL 2090|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P900061|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MICRO JEWELL II ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P980016|S111|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P980035|S079|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700/600 SIGMA AND ENRYTHM IPG'S|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P990001|S033|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P010015|S034|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III CRT-IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P820003|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS FAMILIES OF PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P850051|S066|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VARIOUS FAMILIES OF PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P930022|S006|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P970012|S030|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P980050|S030|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF, GEM III FAMILY OF ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P010031|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS FAMILIES OF CRT/ICD'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2007|05/09/2008|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE.
P930021|S010|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMODOGAIN|NQA|DE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/09/2007|11/28/2007|||APPR|APPROVAL FOR TWO MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE: 1) A MODIFICATION OF THE DESCRIPTION OF EMODOGAIN, AND 2) A RESTRICTION OF THE RECOMMENDATION TO THE USE OF PREFGEL TOOTH CONDITIONER.
P010012|S160|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593|LWP|CV|Normal 180 Day Track||N|10/09/2007|05/16/2008|||APPR|APPROVAL FOR THE ACUITY SPIRAL LEAD MODEL 4591, 4592, AND 4593.  THE DEVICE IS INDICATED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.
P990033|S015|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN 15|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2007|01/11/2008|||APPR|APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT STERIGENICS US, INC, GURNEE, ILLINOIS.
P010012|S161|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2007|11/21/2007|||OK30|ADDITION OF A NEW SUPPLIER FOR THIN FILM RESISTOR CHIPS.
P960040|S152|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VR (VENTAK PRIZM) DEVICES|LWP|CV|30-Day Notice||N|10/09/2007|11/21/2007|||OK30|ADDITION OF A NEW SUPPLIER FOR THIN FILM RESISTOR CHIPS.
P050017|S001|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/09/2007|||OK30|CHANGE IN STERILANT.
P020030|S004|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|STELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|10/17/2008|||APPR|APPROVAL FOR A CHANGE INVOLVING ALTERNATE PROCESS PARAMETERS FOR THE MANUFACTURING OF MATERIALS IN THE STEROID COLLAR COMPONENTS.
P910077|S080|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/14/2007|||OK30|REPLACEMENT OF THE DEPANELIZATION EQUIPMENT AND ENHANCEMENT OF A VISUAL INSPECTION FOR THE DAUGHTER BOARD OF THE DEVICE.
P030017|S029|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/18/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC NEUROMODULATION, VALENCIA, CALIFORNIA.
P980035|S080|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/16/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY.
P990001|S034|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/16/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY.
P980050|S031|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/16/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY.
P980016|S112|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/16/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY.
P890003|S130|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/THERA-I PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/16/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY.
P010015|S035|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC CRT-P, INSYNC II CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/16/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY.
P970012|S031|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR IPG AND KAPPA 400 SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/16/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY.
P010031|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC CRT-D; CONCERTO & VARIOUS INSYNC FAMILY OF ICDS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2007|11/16/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY.
P040023|S010|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|30-Day Notice||N|10/12/2007|11/14/2007|||OK30|IMPLEMENTATION OF A MANUFACTURING CHANGE MADE BY THE CONTRACT SUPPLIER, CERAMTEC.
P910066|S024|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|10/12/2007|12/10/2007|||APPR|APPROVAL FOR THE MODIFICATION OF THE EXISTING COIL GEOMETRY, THE ADDITION OF A WIRED CONTROL BOX, THE RECONFIGURATION OF THE PATIENT PADDING SYSTEM, AND THE REMOVAL OF THE INFRARED PATIENT COMPLIANCE COMPONENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES.
P790007|S021|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2007|11/21/2007|||OK30|ALTERNATE MANUFACTURING LOCATION FOR SEVERAL SUB-ASSEMBLY COMPONENTS.
P980043|S014|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2007|11/21/2007|||OK30|ALTERNATE MANUFACTURING LOCATION FOR SEVERAL SUB-ASSEMBLY COMPONENTS.
P990064|S021|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PROCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2007|11/21/2007|||OK30|ALTERNATE MANUFACTURING LOCATION FOR SEVERAL SUB-ASSEMBLY COMPONENTS.
P970031|S022|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2007|11/21/2007|||OK30|ALTERNATE MANUFACTURING LOCATION FOR SEVERAL SUB-ASSEMBLY COMPONENTS.
P020004|S031|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/15/2007|11/15/2007|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE PACKAGING TRAY.
P970003|S092|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2007|11/14/2007|||OK30|ADDITION OF AN AUTOMATED ELECTRICAL TEST STATION.
P970003|S093|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/23/2007|12/21/2007|||APPR|APPROVAL FOR AN ALTERNATE COMPONENT TO THE DEMIPULSE (MODEL 103) AND DEMIPULSE DUO (MODEL 104) PULSE GENERATORS PRINTED CIRCUIT BOARD (PCB) ASSEMBLY.
P040033|S007|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2007|06/20/2008|||APPR|APPROVAL FOR AUTOMATION OF TWO MANUFACTURING PROCESSES UTILIZING CNC MACHINING.
P000032|S022|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2007|03/21/2008|||APPR|APPROVAL FOR A PROPOSED CHANGE TO ELIMINATE THE POST STERILE AUDIT TEST PROCESS FOR THE HER OPTION CRYOABLATION SYSTEM DISPOSABLE PROBE.
P960040|S153|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM2/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2007|10/29/2007|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER OF THIN FILM RESISTORS.
P010012|S162|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTACT RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2007|10/29/2007|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER OF THIN FILM RESISTORS.
P970008|S034|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/2007|04/07/2008|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE TARGIS CONTROL UNIT MODEL 4000 AND COOLWAVE CONTROL UNIT MODEL 5000 AND A RELATED LABELING CHANGE TO THE USER MANUAL FOR THE COOLWAVE CONTROL UNIT.
P980016|S113|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2007|11/16/2007|||OK30|CHANGE TO THE CLEANING PROCESS IN THE FLEX ASSEMBLY PROCESS.
P010031|S083|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2007|11/16/2007|||OK30|CHANGE TO THE CLEANING PROCESS IN THE FLEX ASSEMBLY PROCESS.
P860004|S094|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP MODEL 8637|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|10/18/2007|01/16/2009|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO THE SYNCHROMED II PUMP IN REGARDS TO THE PUMP HEAD CREW AND POGO PIN.
P050051|S002|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/19/2007|12/05/2007|||APPR|APPROVAL FOR CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN AND CHANGE OF GRAYZONE RANGE.
P840001|S102|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/19/2007|03/15/2011|||APPR|APPROVAL FOR MINOR FIRMWARE CHANGE.
P020040|S007|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 8|POB 58165|TEL-AVIV||61581||STENT, CORONARY|NIRFLEX PREMOUNTED CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/23/2008|||APPR|APPROVAL FOR CHANGING THE STERILIZATION LOAD CONFIGURATION AND TEMPERATURE IN THE AERATION CHAMBER FOR NIRFLEX STENTS.
P880086|S155|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, AND ZEPHYR PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P970013|S021|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P880006|S054|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|REGENCY PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P960013|S035|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL, TENDRIL ST, AND OPTISENSE LEADS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P960030|S019|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS, ISOFLEX S/P, AND ISOFLEX OPTIM LEADS|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P950022|S045|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA, RIATA ST, AND DURATA LEADS|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P030035|S036|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II CRT-P¿S AND AESCULA LEADS|NKE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P030054|S072|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D AND QUICKSITE & QUICKFLEX LEADS|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P910023|S159|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2007|05/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
P910023|S160|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2007|12/07/2007|||APPR|APPROVAL FOR THE MERLIN.NET VERSION 2.5.  IT CONSISTS OF THE MATRIX PCS RELEASE 2.5, WHICH IS THE HOUSECALL RECEIVER SOFTWARE, VERSION 4000-3.5.1 AND THE RECEIVER MANAGER SOFTWARE.
P930038|S051|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2007|11/29/2007|||OK30|USE OF AN ALTERNATIVE SIX (6) HOUR VACUUM DRYING PROCESS.
P040043|S019|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/2007|03/04/2009|||APPR|APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE WITH CLINICAL DATA ON SUBJECTS WITH RUPTURED ANEURYSMS OF THE DESCENDING THORACIC AORTA.
P020026|S044|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENTS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2007|05/29/2008|||APPR|APPROVAL FOR A SITE TRANSFER OF THE BACTERIAL ENDOTOXINS TEST AND BIOBURDEN MICROBIOLOGICAL TESTS.
P040052|S005|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|MONOPREP PAP TEST|MKQ|PA|Normal 180 Day Track No User Fee|Express GMP Supplement|N|10/22/2007|08/11/2008|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED IN LINCOLNSHIRE, ILLINOIS AND WAUKEGAN, ILLINOIS.
P910023|S161|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY ICD'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2007|12/19/2007|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REPLACE THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITH PLUG/RECEPTACLE CONNECTORS; 2) AN ORGANIC SUBSTRATE WILL BE USED FOR THE HYBRID MODULE; AND 3) DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS WERE RE-CONFIGURED INTO SURFACE-MOUNTABLE PACKAGES.
P030054|S073|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2007|12/19/2007|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REPLACE THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITH PLUG/RECEPTACLE CONNECTORS; 2) AN ORGANIC SUBSTRATE WILL BE USED FOR THE HYBRID MODULE; AND 3) DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS WERE RE-CONFIGURED INTO SURFACE-MOUNTABLE PACKAGES.
P950037|S055|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ICS 3000 IMPLANT CONTROL SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/23/2007|12/07/2007|||APPR|APPROVAL FOR CHANGES TO THE ICS 300 PROGRAMMER HEAD, TECHNICAL MANUAL, AND THE PGH BLUE FOIL LABEL.
P960043|S061|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEMS|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2007|11/21/2007|||OK30|CHANGE TO THE STERILIZATION LOAD SIZE FROM 6 TO 13 PALLETS AND A CHANGE TO THE BIOLOGICAL INDICATORS (BIS), WHICH NOW CONSIST OF AN INOCULATED PEEBAX TUBE IN AN ENVELOPE.
P890055|S023|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 IMPLANTABLE INFUSION PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|10/23/2007|11/26/2007|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT AND TO THE CODMAN 3000 PUMP ACCESSORIES: 1) REPLACE 3 MM-BEVELED TUOHY NEEDLE WITH A 4 MM-BEVELED TUOHY NEEDLE; 2) REMOVE A RULER; 3) REPLACE REMAINING RULER WITH A NEW RULER; 4) REDUCE AERATION TIME FOR CODMAN 3000 PUMP ACCESSORIES; 5) NEW PACKAGING DESIGN; 6) NEW PACKAGING MATERIALS; 7) UPDATE LABELING TO REFLECT COMPONENT CHANGES; AND 8) CLARIFY ADDITIONAL NON-PYROGENIC COMPONENTS AND PROCEDURAL STEPS.
P960043|S062|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2007|11/21/2007|||OK30|SEVERAL IMPROVEMENTS TO THE CUFF SWAGING MACHINE.
P040045|S002|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON SENOFILCON A CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2007|03/31/2008|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT JOHNSON & JOHNSON (IRELAND) LTD., LIMERICK, IRELAND.
P030054|S074|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2007|12/12/2007|||APPR|APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE.  FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE.  DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS.  FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.
P910023|S162|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2007|12/12/2007|||APPR|APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE.  FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE.  DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS.  FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.
P030035|S037|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2007|12/12/2007|||APPR|APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE.  FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE.  DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS.  FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.
P880006|S055|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2007|12/12/2007|||APPR|APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE.  FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE.  DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS.  FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.
P880086|S156|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2007|12/12/2007|||APPR|APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE.  FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE.  DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS.  FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.
P970013|S022|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2007|12/12/2007|||APPR|APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE.  FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE.  DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS.  FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.
P040025|S006|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP SYSTEM|MXM|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2007|02/05/2008|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE PUMP MOTOR DRIVE AND CHANGES TO THE CONTROL MODULE AND TEMPERATURE SENSOR MODULE TO RELIABLY MEET ELECTRICAL FAST TRANSIENT (EFT) TESTING.
P980022|S021|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/2007|04/18/2008|||APPR|APPROVAL FOR AN OPTIONAL CAPABILITY OF AUTOMATICALLY DOWNLOADING GLUCOSE RESULTS FROM THE LIFESCAN ONETOUCH ULTRALINK BLOOD GLUCOSE METER IN ADDITION TO THE CURRENT BD PARADIGM LINK GLUCOSE METER. THIS MODIFICATION INCLUDES AN OPTIONAL CAPABILITY FOR THE MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMPS OR THE GUARDIAN REAL-TIME GLUCOSE MONITOR TO RECEIVE BLOOD GLUCOSE VALUES AUTOMATICALLY TRANSMITTED BY A LIFESCAN ONETOUCH ULTRALINK BLOOD GLUCOSE METER.  THE GUARDIAN? REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, IN CHILDREN AND ADULTS, AGES 7 AND UP, WITH DIABETES MELLITUS, FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. IT ALERTS IF A GLUCOSE LEVEL FALLS BELOW, OR RISES ABOVE, PRESET VALUES. VALUES ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR. THE SYSTEM PROVIDES REAL-TIME GLUCOSE VALUES THAT ALLOW USERS TO TRACK PATTERNS IN GLUCOSE CONCENTRATIONS AND TO POSSIBLY IDENTIFY EPISODES OF LOW AND HIGH BLOOD GLUCOSE. IT ALSO STORES THE DATA SO THAT IT CAN BE ANALYZED TO TRACK PATTERNS.  GLUCOSE DATA CAN BE FURTHER DOWNLOADED TO PC SOFTWARE FOR ANALYSIS OF HISTORICAL GLUCOSE VALUES.  THE GUARDIAN REAL-TIME MONITOR CAN BE PROGRAMMED TO RECEIVE FINGERSTICK BLOOD GLUCOSE CALIBRATION VALUES TRANSMITTED FROM THE BD PARADIGM LINK OR LIFESCAN ONETOUCH ULTRALINK GLUCOSE METERS.  CALIBRATION VALUES FROM OTHER GLUCOSE METERS MUST BE MANUALLY ENTERED INTO THE MONITOR.  THE PARADIGM? REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, AND POSSIBLE LOW AND HIGH BLOOD GLUCOSE EPISODES IN CHILDREN AND ADULTS, AGES 7 AND UP....(SEE APPROVAL ORDER FOR ADDITIONAL INFO)
P000025|S029|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR|MCM|EN|Normal 180 Day Track||N|10/25/2007|04/08/2008|||APPR|APPROVAL FOR THE OPUS 2 SPEECH PROCESSOR AS AN ADDITIONAL EXTERNAL BEHIND-THE-EAR SPEECH PROCESSOR FOR USE WITH THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.
P000009|S024|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LEXOS AND LUMOS ICDS & XELOS DR-T ICD|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/2007|03/11/2008|||APPR|APPROVAL FOR A CHANGE IN THE CHEMICAL FORMULATION OF THE MANGANESE BINDING AGENT USED IN THE CONSTRUCTION OF BATTERIES TO PTFE DISPERSION DYNEON TF 5032 R.
P050023|S008|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX ICDS & CRT-DS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/2007|03/11/2008|||APPR|APPROVAL FOR A CHANGE IN THE CHEMICAL FORMULATION OF THE MANGANESE BINDING AGENT USED IN THE CONSTRUCTION OF BATTERIES TO PTFE DISPERSION DYNEON TF 5032 R.
P040001|S008|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM|NQO|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2007|12/14/2007|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT KYPHON, INC., SUNNYVALE, CALIFORNIA, FOR INSPECTION, PACKAGING AND FINAL ACCEPTANCE.
P050042|S003|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT ARCHITECT ANTI-HCV|MZO|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/29/2007|12/10/2007|||APPR|APPROVAL FOR CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN.
P070009|S001|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|SWEDISH ADJUSTABLE GASTRIC BAND|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/29/2007|09/09/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P950032|S045|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/29/2007|08/17/2010|||APPR|APPROVAL FOR REVISIONS TO THE DIABETIC FOOT ULCER AND VENOUS LEG ULCER PATIENT BROCHURES.
P040005|S002|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 FISH PHARMDX KIT|MVD|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/29/2007|02/13/2008|||APPR|APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES IN VIAL 3 PROBE MIX, ADJUSTMENT OF THE HER2 GENE TARGETED DNA PROBE CONCENTRATIONS IN VIAL 3 PROBE MIX, CHANGE IN AUXILIARY MATERIALS IN TEXAS RED NICK TRANSLATION AND USE OF SEPHADEX G-50 COLUMNS FOR PURIFICATION OF NICK TRANSLATION PRODUCTS.
P040024|S015|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2007|06/13/2008|||APPR|APPROVAL FOR NEW PROCESSING VESSELS AND FOR CHANGES IN THE CLEANING PROCESS FOR THOSE VESSELS.
P930016|S028|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2007|04/09/2008|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMP MANUFACTURING USA, LLC, MILPITAS, CALIFORNIA.
P040024|S016|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2007|06/13/2008|||APPR|APPROVAL FOR NEW PROCESSING VESSELS AND FOR CHANGES IN THE CLEANING PROCESS FOR THOSE VESSELS.
P930014|S022|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2007|11/30/2007|||OK30|ALTERNATE FORMULATION MIXING MASTER BATCHING PROCESS IMPROVEMENT.
P040020|S006|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF INTRAOCULAR LENSES (IOL)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2007|11/30/2007|||OK30|ALTERNATE FORMULATION MIXING MASTER BATCHING PROCESS IMPROVEMENT.
P990019|S005|DUSA PHARMACEUTICALS, INC.|25 UPTON DR.||WILMINGTON|MA|01887||SYSTEM, LASER, PHOTODYNAMIC THERAPY|BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170|MVF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2007|10/10/2008|||APPR|APPROVAL FOR THE NATIONAL BIOLOGICAL CORP., BEACHWOOD, OHIO FACILITY, FOR CONTRACT MANUFACTURING.
P030039|S007|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2007|11/30/2007|||OK30|CHANGE TO A NEW WAREHOUSE FOR STORAGE OF RAW MATERIALS AND FINISHED DEVICES.
P930016|S029|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/31/2007|04/02/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010031|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA CRT-D & MAXIMO II CRT-D|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/2007|03/17/2008|||APPR|APPROVAL FOR REMOVAL OF THE CONTRAINDICATION: ?PATIENTS WHOSE PRIMARY DISORDER IS BRADYARRHYTHMIA? AND FOR THE MEDTRONIC CONSULTA  CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284DRG, MAXIMO II VR D284VRC, MODEL 9995 APPLICATION SOFTWARE VERSION 1.1 SYSTEMS, MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME: MEDTRONIC CONSULTA  CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284VRC, MAXIMO II VR D284DRG MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  IN ADDITION, THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION.  ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP) AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION.
P890003|S131|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC 2490C CARELINK MONITOR 2020A CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/2007|03/17/2008|||APPR|APPROVAL FOR REMOVAL OF THE CONTRAINDICATION: ?PATIENTS WHOSE PRIMARY DISORDER IS BRADYARRHYTHMIA? AND FOR THE MEDTRONIC CONSULTA  CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284DRG, MAXIMO II VR D284VRC, MODEL 9995 APPLICATION SOFTWARE VERSION 1.1 SYSTEMS, MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME: MEDTRONIC CONSULTA  CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284VRC, MAXIMO II VR D284DRG MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  IN ADDITION, THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION.  ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP) AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION.
P980016|S114|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/2007|03/17/2008|||APPR|APPROVAL FOR REMOVAL OF THE CONTRAINDICATION: ?PATIENTS WHOSE PRIMARY DISORDER IS BRADYARRHYTHMIA? AND FOR THE MEDTRONIC CONSULTA  CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284DRG, MAXIMO II VR D284VRC, MODEL 9995 APPLICATION SOFTWARE VERSION 1.1 SYSTEMS, MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME: MEDTRONIC CONSULTA  CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284VRC, MAXIMO II VR D284DRG MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.  IN ADDITION, THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION.  ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP) AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION.
P050039|S001|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|NOVATION CERAMIC AHS|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2007|11/13/2008|||APPR|APPROVAL FOR AN ADDITIONAL MACHINING PROCESSES AT EXACTECH, INC. IN GAINESVILLE, FLORIDA.
P990009|S020|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2007|11/30/2007|||OK30|CHANGE TO A NEW WAREHOUSE FOR STORAGE OF FINISHED DEVICES AND RAW MATERIALS.
P990040|S006|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFIL N-BCA LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2007|11/30/2007|||OK30|CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).
P970020|S051|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX ULTRA CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2007|11/30/2007|||OK30|ADDITION OF A VISUAL INSPECTION STEP TO THE MANUFACTURING PROCESS.
P880003|S093|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|PTCA DILATATION CATHETERS|LOX|CV|30-Day Notice||N|11/02/2007|11/30/2007|||OK30|CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).
P020036|S009|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART NITINOL SYSTEM & SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice||N|11/02/2007|11/30/2007|||OK30|CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).
P030047|S008|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE NITINOL STENT SYSTEM & PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM|NIM|CV|30-Day Notice||N|11/02/2007|11/30/2007|||OK30|CHANGE TO THE BIOLOGICAL INDICATORS USED TO MONITOR THE ETHYLENE OXIDE STERILIZATION CYCLES (USE OF A SELF CONTAINED BIOLOGICAL INDICATOR IN PLACE OF A SPORE STRIP BIOLOGICAL INDICATOR).
P050009|S005|Biomet, Inc.|P.O. Box 587||Warsaw|IN|46581|0587|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|C2-A TAPER ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2007|11/30/2007|||OK30|CHANGE BY THE SUPPLIER TO IMPLEMENT NEW SOFTWARE ON THE MANUFACTURING LINE.
P950029|S032|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/2007|07/25/2008|||APPR|APPROVAL FOR REPLY SR/DR PACEMAKER MODELS AND SMARTVIEW 2.08UG1 PROGRAMMING SOFTWARE MANUFACTURED BY SORIN BIOMEDICA CRM, S.R.L., SALUGGIA (VC) ITALY.
P950022|S046|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST FAMILY OF LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2007|12/21/2007|||APPR|APPROVAL FOR A CHANGE TO THE SHOCK COIL BACKFILL MANUFACTURING PROCESS.
P030002|S013|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL)|NAA|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/05/2007|12/12/2007|||APPR|APPROVAL FOR INCLUSION OF THE MICROSTAAR MSI-PR AND MSI-TR INJECTORS AND MTC-60C CARTRIDGE IN THE PHYSICIAN LABELING FOR THE CRYSTALENS MODELS AT-50SE AND AT-52SE.
P040040|S001|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|12/05/2007|||OK30|CHANGE TO AN INSPECTION PROCEDURE.
P020004|S032|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|12/06/2007|||OK30|ADOPTION OF AN ELECTRONIC VERIFICATION SYSTEM (EVS) TO BE USED IN THE PACKAGING OF THE DEVICE.
P050006|S005|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|12/06/2007|||OK30|ADOPTION OF AN ELECTRONIC VERIFICATION SYSTEM (EVS) TO BE USED IN THE PACKAGING OF THE DEVICE.
P040043|S020|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|12/06/2007|||OK30|ADOPTION OF AN ELECTRONIC VERIFICATION SYSTEM (EVS) TO BE USED IN THE PACKAGING OF THE DEVICE.
P040037|S006|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|12/06/2007|||OK30|ADOPTION OF AN ELECTRONIC VERIFICATION SYSTEM (EVS) TO BE USED IN THE PACKAGING OF THE DEVICE.
P040027|S008|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|12/06/2007|||OK30|ADOPTION OF AN ELECTRONIC VERIFICATION SYSTEM (EVS) TO BE USED IN THE PACKAGING OF THE DEVICE.
P000058|S026|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|08/15/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO, AND A STERILIZING SITE AT STERITECH, INC., SALINAS, PUERTO RICO.
P000054|S015|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|08/15/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO, AND A STERILIZING SITE AT STERITECH, INC., SALINAS, PUERTO RICO.
P050053|S005|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|08/15/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO, AND A STERILIZING SITE AT STERITECH, INC., SALINAS, PUERTO RICO.
P050044|S002|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|12/17/2007|||APPR|APPROVAL FOR A CONTRACT STERILIZATION FACILITY LOCATED AT STERIGENICS INTERNATIONAL, SAN DIEGO, CALIFORNIA.
P050044|S003|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2007|12/17/2007|||APPR|APPROVAL FOR A CONTRACT TESTING FACILITY LOCATED AT LEXAMED, TOLEDO, OHIO.
P030017|S030|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2007|07/22/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC NEUROMODULATION CORPORATION IN VALENCIA, CALIFORNIA.
P010012|S163|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2007|12/05/2007|||OK30|CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.
P030005|S048|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTRAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2007|12/05/2007|||OK30|CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.
P910077|S081|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI & CONTAK RENEWAL 3|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2007|12/05/2007|||OK30|CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.
P940031|S062|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR/DISCOVER/MERIDIAN/PDP|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2007|12/05/2007|||OK30|CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.
P960040|S154|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2007|12/05/2007|||OK30|CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.
P020026|S045|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2007|12/13/2007|||OK30|MODIFICATION TO THE LASER CUTTING PROCESS.
P020026|S046|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2007|02/08/2008|||APPR|APPROVAL FOR THE INTRODUCTION OF A MAXIMUM SPECIFIED TIME FOR PROTECTING AND STORING DEVICES DURING AN ENVIRONMENTAL EXCURSION.
P880091|S023|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/09/2007|12/04/2007|||APPR|APPROVAL FOR A CHANGE IN THE APPROVED POLYCARBONATE PACKAGING MATERIAL THAT IS IN DIRECT CONTACT WITH THE LENS DURING STEAM STERILIZATION AND THROUGHOUT THE SHELF-LIFE OF THE LENS.
P020026|S047|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2007|12/13/2007|||OK30|CHANGE IN THE QUALITY CONTROL TEST USED TO DETERMINE MEDIA SUITABILITY FOR SUSTAINING MICROBIAL GROWTH FOR THE DEVICE.
P790017|S093|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2007|12/11/2007|||OK30|REDUCTION IN THE NUMBER OF IN-PROCESS TENSILE TEST SAMPLES FOR THE NC STORMER OTW AND SPRINTER OTW BALLOON DILATATION CATHETER PRODUCTS AT THE BOND BIFURCATE LUER TO INNER SHAFT WORK-STEP.
P030035|S038|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2007|12/11/2007|||OK30|ALTERNATE PROCESS FOR ADHERING THE HYBRID SUBSTRATE TO THE HYBRID SUPPORT.
P880086|S157|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2007|12/11/2007|||OK30|ALTERNATE PROCESS FOR ADHERING THE HYBRID SUBSTRATE TO THE HYBRID SUPPORT.
P050047|S002|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONANTE GEL IMPLANTS|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2007|11/30/2007|||APPR|APPROVAL FOR CLARIFICATIONS TO THE NEEDLE ATTACHMENT INSTRUCTIONS AND JUVEDERM 30 PHYSICIAN INSTRUCTIONS.
P980043|S015|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510|DYE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2007|12/12/2007|||APPR|APPROVAL FOR THE ADDITION OF A CAUTION STATEMENT TO THE LABELING.
P990064|S022|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310|DYE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2007|12/12/2007|||APPR|APPROVAL FOR THE ADDITION OF A CAUTION STATEMENT TO THE LABELING.
P910073|S068|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2007|12/19/2007|||OK30|CHANGE TO: 1) THE PACKAGING LOCATION FROM AVID MEDICAL TO CODMAN & SHURTLEFF, INC.; 2) THE PACKAGING COMPONENT SUPPLIERS; AND 3) THE TOUHY NEEDLES AND RULER SUPPLIERS.
P840064|S033|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT,DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2007|12/14/2007|||OK30|ADDITION OF A NEW ANALYTICAL METHOD FOR THE DETERMINATION OF ETHYLENE OXIDE RESIDUALS.
P890047|S020|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2007|12/14/2007|||OK30|ADDITION OF A NEW ANALYTICAL METHOD FOR THE DETERMINATION OF ETHYLENE OXIDE RESIDUALS.
P990020|S028|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE XCELERANT HYDRO DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2007|12/06/2007|||APPR|APPROVAL FOR THE ADDITION OF A HYDROPHILIC COATING TO THE DEVICE.
P030039|S008|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2007|12/14/2007|||OK30|CHANGE IN SUPPLIER AND A CHANGE TO THE SYRINGE FILLING PROCESS.
P010041|S014|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRA-ANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2007|12/13/2007|||OK30|CHANGE IN SUPPLIER FOR PET-YARN.
P000007|S013|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2007|12/13/2007|||OK30|CHANGE IN SUPPLIER FOR PET-YARN.
P870077|S025|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2007|12/13/2007|||OK30|CHANGE IN SUPPLIER FOR PET-YARN.
P870056|S027|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2007|12/13/2007|||OK30|CHANGE IN SUPPLIER FOR PET-YARN.
P860057|S044|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2007|12/13/2007|||OK30|CHANGE IN SUPPLIER FOR PET-YARN.
P040044|S004|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2007|12/17/2007|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING AND TESTING PROCESS FOR THE DEVICE.
P880086|S158|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2007|12/14/2007|||OK30|ALTERNATE MANUFACTURING PROCESS FOR ATTACHMENT OF THE HEADER FOR THE DEVICE.
P050038|S004|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2007|01/14/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ENPATH MEDICAL, INC., MINNEAPOLIS, MINNESOTA TO PERFORM FILLING, PACKAGING, AND LABELING OF THE DEVICE.
P000058|S027|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/16/2007|03/21/2008|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PACKAGE INSERT: 1) INCLUSION OF WARNINGS RELATED TO LOCALIZED, TRANSIENT BONE RESORPTION AND POSSIBLE NERVE COMPRESSION DUE TO ECTOPIC BONE FORMATION PROMPTED BY A LABELING MODIFICATION REQUIRED BY THE EU AS A RESULT OF AN ANALYSIS OF REPORTED ADVERSE EVENTS; 2) INCLUSION OF CLINICAL AND ADVERSE EVENT DATA RESULTING FROM THE CLINICAL POST APPROVAL STUDY; 3) INCLUSION OF A WARNING RELATED TO ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH OVER STUFFING THE SCAFFOLD COMPONENT INTO A SMALL VOLUME OR HYPERCONCENTRATING THE RECOMBINANT HUMAN PROTEIN COMPONENT; 4) INCLUSION OF REFERENCES TO PREVIOUSLY APPROVED XS AND XXS KITS; AND 5) STRENGTHENING THE LANGUAGE STATING THAT THE COMPONENTS OF THE PRODUCT MAY ONLY BE USED TOGETHER AND NOT WITH OTHER DEVICES OR COMPONENTS, E.G., SCAFFOLDS OTHER THAN THE ACS.
P000054|S016|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/16/2007|03/17/2008|||APPR|APPROVAL FOR INCLUSION OF A WARNING RELATED TO LOCALIZED, TRANSIENT BONE RESORPTION IN THE PACKAGE INSERT.  THE INCLUSION OF THIS ADDITIONAL WARNING WAS PROMPTED BY A LABELING MODIFICATION REQUIRED BY THE EU AS A RESULT OF AN ANALYSIS OF REPORTED ADVERSE EVENTS.
P980016|S115|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2007|12/04/2007|||APPR|APPROVAL FOR MINOR DESIGN CHANGES THAT ADD TWO ALTERNATE TANTALUM CAPACITORS (XTC017, XTC018) WITH INCREASED VOLTAGE RATINGS TO APPROVED DEVICE COMPONENTS.  THE DESIGN MODIFICATIONS ARE INTENDED TO REDUCE MANUFACTURING YIELD LOSS AND ASSOCIATED REWORK.
P010031|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC II MARQUIS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2007|12/04/2007|||APPR|APPROVAL FOR MINOR DESIGN CHANGES THAT ADD TWO ALTERNATE TANTALUM CAPACITORS (XTC017, XTC018) WITH INCREASED VOLTAGE RATINGS TO APPROVED DEVICE COMPONENTS.  THE DESIGN MODIFICATIONS ARE INTENDED TO REDUCE MANUFACTURING YIELD LOSS AND ASSOCIATED REWORK.
P980035|S081|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM P1501 DR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2007|12/04/2007|||APPR|APPROVAL FOR MINOR DESIGN CHANGES THAT ADD TWO ALTERNATE TANTALUM CAPACITORS (XTC017, XTC018) WITH INCREASED VOLTAGE RATINGS TO APPROVED DEVICE COMPONENTS.  THE DESIGN MODIFICATIONS ARE INTENDED TO REDUCE MANUFACTURING YIELD LOSS AND ASSOCIATED REWORK.
P990009|S021|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/27/2007|||OK30|CHANGE IN EXTRUSION FORCE STABILITY LIMIT.
P990081|S007|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU|MVC|PA|30-Day Notice||N|11/19/2007|12/12/2007|||OK30|CHANGE IN THE RAW MATERIAL USED TO MANUFACTURE CELL LINE MULTIBLOCKS TO ELIMINATE BACKGROUND STAINING OF THE CONTROL SLIDES.
P840001|S103|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/18/2007|||OK30|REMOVAL OF THE THERMAL SHOCK TEST AS PART OF THE BATTERY MANUFACTURING PROCESS.
P970004|S045|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY  FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/18/2007|||OK30|REMOVAL OF THE THERMAL SHOCK TEST AS PART OF THE BATTERY MANUFACTURING PROCESS.
P000043|S020|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATRX OFFICE THERMOTHERAPY SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/17/2007|||OK30|TRANSFER OF THE LABEL GENERATION PROCESS FOR A CATHETER FROM THE AMS MINNETONKA FACILITY TO MRI MEDICAL, IN TUCSON, ARIZONA.
P890055|S024|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|FLEXTIP PLUS INTRASPINAL CATHETER KIT|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/18/2007|||OK30|CHANGE TO: 1) THE PACKAGING LOCATION FROM AVID MEDICAL TO CODMAN & SHURTLEFF, INC.; 2) THE PACKAGING COMPONENT SUPPLIERS; AND 3) THE TOUHY NEEDLES AND RULER SUPPLIERS.
P030024|S007|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2007|02/12/2008|||APPR|APPROVAL FOR THE ADDITION OF A NEW PROCESS STEP TO IDENTIFY AND DILUTE SAMPLES WITH HIGH RESULT SIGNAL-TO-CUTOFF RATIO (S/C) ABOVE THE NORMAL NEGATIVE POPULATION AND THE CHANGES INVOLVED IN ADDING THIS NEW PROCESS.  THESE CHANGES ARE AN UPDATE TO THE MAGNETIC CARD AND TO THE LABELING OF THE VITROS ANTI-HBC REAGENT PACK TO SUPPORT THE IDENTIFICATION, DILUTION AND TESTING OF THE HIGH NEGATIVE SAMPLES.
P970003|S094|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/19/2007|||OK30|ADD ADDITIONAL DETAILS TO THE INSPECTION CRITERIA FOR DELAMINATION AND CONSTRAINED COIL IN LEAD MODELS 302 AND 303.
P980016|S116|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST & VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/18/2007|||OK30|REMOVAL OF THE THERMAL SHOCK PROCESS PERFORMED ON BATTERY FEEDTHROUGHS AT THE SUPPLIER.
P010031|S086|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/18/2007|||OK30|REMOVAL OF THE THERMAL SHOCK PROCESS PERFORMED ON BATTERY FEEDTHROUGHS AT THE SUPPLIER.
P980035|S082|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/18/2007|||OK30|REMOVAL OF THE THERMAL SHOCK PROCESS PERFORMED ON BATTERY FEEDTHROUGHS AT THE SUPPLIER.
P980035|S083|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P970012|S032|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR & SR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P010031|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC FAMILIES OF ICD & CONCERTO ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P010015|S036|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC CRT-P & INSYNC III CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P890003|S132|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/THERA I IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P980016|S117|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P010014|S018|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2007|02/25/2008|||APPR|APPROVAL FOR BIOMET FAIR LAWN, L.PL, LOCATED IN FAIR LAWN, NEW JERSEY, TO BE ADDED AS A MATERIAL VENDOR AND CONTRACT MANUFACTURER FOR THE CASTING PROCESS.
P040047|S004|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2007|04/29/2008|||APPR|APPROVAL FOR AN UPGRADE TO THE EXTERNAL SOFTWARE INTERFACE TO THE STERILIZER.
P050037|S004|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2007|05/01/2008|||APPR|APPROVAL FOR NEW UPGRADED EXTERNAL INTERFACE SOFTWARE FOR A STEAM STERILIZER.
P050052|S005|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2007|05/01/2008|||APPR|APPROVAL FOR NEW UPGRADED EXTERNAL INTERFACE SOFTWARE FOR A STEAM STERILIZER.
P040045|S003|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON SENOFILCON A CONTACT LENS FOR EXTENDED WEAR|LPM|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/20/2007|01/18/2008|||APPR|APPROVAL FOR MINOR LABELING CHANGES.
P040037|S007|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/20/2007|08/14/2008|08M-0467|08/21/2008|APPR|APPROVAL OF AN EXTENSION OF THE INDICATIONS FOR USE TO INCLUDE ILIAC ARTERIAL LESIONS.  THE DEVICE IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN ILIAC ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0-12.0 MM.
P960013|S036|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL FAMILY OF LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/18/2007|||OK30|EXTENDED TIME BETWEEN PLASMA TREATMENT AND APPLICATION OF MEDICAL ADHESIVE.
P950022|S047|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/18/2007|||OK30|EXTENDED TIME BETWEEN PLASMA TREATMENT AND APPLICATION OF MEDICAL ADHESIVE.
P950022|S048|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2007|12/19/2007|||OK30|ALTERNATE OVEN SETTINGS DURING PROCESSING OF SHOCK COILS.
P930016|S030|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2007|01/16/2008|||APPR|APPROVAL FOR THE UPGRADE WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.90.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM AND ARE INDICATED FOR WAVEFRONT-GUIDED (WRG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TO ACHIEVE EYE OF PRESBYOPIC MYOPES: 1) 40 YEARS OR OLDER WHO MAY BENEFIT FROM INCREASED SPECTACLE INDEPENDENCE ACROSS A RANGE OF DISTANCES WITH USEFUL NEAR VISION; 2) WITH MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER UP TO -3.00 D, AND MINIMUM PRE-OPERATIVE MYOPIA IN THEIR NON-DOMINANT EYE AT LEAST AS GREAT AS THEIR TARGETED MYOPIA; 3) WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.50 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PREOPERATIVE EXAMINATION; AND 4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION EXPERIENCE.
P970003|S095|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/2007|12/19/2007|||APPR|APPROVAL FOR CHANGES CONSISTING OF ADDING ?SEROMA? AS AN ADDITIONAL POSSIBLE ADVERSE EVENT IN THE EPILEPSY AND DEPRESSION INFORMATION MODULES AND ADDING A NOTE DESCRIBING POSSIBLE RISKS WITH REPLACING A LARGER PULSE GENERATOR WITH A SMALLER ONE IN THE REVISION/ REPLACEMENT/ REMOVAL MODULE.
P030047|S009|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL STENT|NIM|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/21/2007|04/14/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING TO INCLUDE THE POST-APPROVAL STUDIES FINDINGS.
P050046|S002|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/23/2007|03/05/2008|||APPR|APPROVAL FOR A SPECIFICATION CHANGE FOR ACCEPTANCE OF SILICONE TUBING USED TO MANUFACTURE ACUITY STEERABLE LEADS.
P960009|S045|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|KINETRA & SOLETRA FAMILY OF NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P840001|S104|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, SYNERGY, RESTORE PRIME & PRIME ADVANCED FAMILY OF IPGS OR IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P970004|S046|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P860004|S095|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II PUMP||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2007|12/11/2007|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
P030031|S009|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DIAGNOSTIC/ABLATION CATHETERS|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2007|09/30/2008|||APPR|APPROVAL FOR INCORPORATION OF A BIDIRECTIONAL DEFLECTION MECHANISM IN THE NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV CATHETERS AND INDICATED FOR TREATMENT OF TYPE I ATRIAL FLUTTER AND RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA.
P040036|S006|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL AND|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2007|09/30/2008|||APPR|APPROVAL FOR INCORPORATION OF A BIDIRECTIONAL DEFLECTION MECHANISM IN THE NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV CATHETERS AND INDICATED FOR TREATMENT OF TYPE I ATRIAL FLUTTER AND RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA.
P040013|S012|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S (GROWTH ENHANCED MATRIX)|NPZ|DE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/23/2007|09/03/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P030025|S050|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2007|12/27/2007|||OK30|USE OF AN INTRA-CAMPUS MANUFACTURING SITE FOR THE POLYMER EXCIPIENT USED IN THE DEVICE.
P000032|S023|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2007|12/20/2007|||OK30|CHANGE TO THE CRYOPROBE HANDLE FOR THE DEVICE.
P030025|S051|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2007|11/18/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION, PLYMOUTH, MINNESOTA TO MANUFACTURE THE POLYMER EXCIPIENT USED IN THE DEVICE.
P990046|S018|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS MECHANICAL HEART VALVES|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2007|09/11/2008|||APPR|APPROVAL FOR CHANGING THE STERILE PRODUCT RELEASE PROCESS.
P990013|S014|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2007|01/25/2008|||APPR|APPROVAL FOR PARAMETRIC LOT RELEASE USING EXISTING VALIDATED STEAM STERILIZATION CYCLES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION CATARACT EXTRACTION.  THE LENS IS TO BE IMPLANTED IN THE POSTERIOR CHAMBER AND IN THE CAPSULAR BAG THROUGH A TEAR-FREE CAPSULORHEXIS (CIRCULAR TEAR ANTERIOR CAPSULOTOMY).
P040048|S003|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2007|04/11/2008|||APPR|APPROVAL FOR A CHANGE BY THE SUPPLIER TO IMPLEMENT NEW SOFTWARE TO THE MANUFACTURING LINE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF THE TWO INNER SPHERE POLISHING STATIONS, WHILE THE OTHER STATION CONTINUES TO BE USED FOR INITIAL PRODUCTION.
P950022|S049|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|DURATA|LWS|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|12/03/2007|01/10/2008|||APPR|APPROVAL FOR A TRADENAME CHANGE FROM RIATA STS OPTIM TO DURATA FOR LEAD MODELS 7120, 7121, 7122, 7130, 7131, 7170 AND 7171.
P000015|S010|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/03/2007|12/31/2007|||APPR|APPROVAL FOR USE OF CUSTOM SOUND 2.0 AND THE FREEDOM SOUND PROCESSOR IN RECIPIENTS OF THE NUCLEUS AUDITORY BRAINSTEM IMPLANT.
P860003|S047|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/03/2007|02/01/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE CENTRIFUGE LID OF THE DEVICE.
P970021|S016|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/03/2007|01/29/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P020037|S002|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|FX MINIRAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2007|01/11/2008|||OK30|CHANGE IN A QUALITY CONTROL TEST USED TO DETERMINE A SPECIFIC ATTRIBUTE OF THE IN PROCESS DEVICE.
P910023|S163|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC & ATLAS ICD FAMILIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2007|01/04/2008|||OK30|ALTERNATE METHOD AND MATERIAL USED TO ATTACH COMPONENTS ON THE ICD/CRT-D.
P030054|S075|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF & HF CRT-D FAMILIES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2007|01/04/2008|||OK30|ALTERNATE METHOD AND MATERIAL USED TO ATTACH COMPONENTS ON THE ICD/CRT-D.
P040027|S009|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2007|04/18/2008|||APPR|APPROVAL FOR CHANGES TO THE ETHYLENE OXIDE STERILIZATION CYCLE.
P010012|S165|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-D|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/2007|05/08/2008|||APPR|APPROVAL FOR THE TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH.  THE COGNIS CRT-D  DEVICES ARE INDICATED FOR PATIENTS WITH MODERATE-TO-SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR (LV) DYSFUNCTION (EJECTION FRACTION <=35%) AND QRS DURATION >=120 MS. THE TELIGEN DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P960040|S155|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/2007|05/08/2008|||APPR|APPROVAL FOR THE TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH.  THE COGNIS CRT-D  DEVICES ARE INDICATED FOR PATIENTS WITH MODERATE-TO-SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR (LV) DYSFUNCTION (EJECTION FRACTION <=35%) AND QRS DURATION >=120 MS. THE TELIGEN DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P050025|S007|BOSTON SCIENTIFIC|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CAROTID|NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM|NIM|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/07/2007|12/20/2007|||APPR|APPROVAL FOR A LABELING CLARIFICATION FOR ?ARRYTHMIA?, THE ADDITION OF ?STENT FRACTURE? TO THE LIST OF POTENTIAL ADVERSE EVENTS, AND CLARIFICATIONS TO THE LABELING TO CLARIFY COMPLETE REMOVAL OF THE DELIVERY SYSTEM TRACKING TIP FROM GUIDE HEATH OR GUIDE CATHETER WHEN REMOVING THE DEVICE UNDER FLUOROSCOPY (ITEMS 11, 12, AND 17 OR TABLE 1).
P950027|S010|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/07/2007|01/08/2008|||APPR|APPROVAL FOR THE FOLLOWING CHANGES IN THE LABEL: 1) THE ADDITION OF THE TRADE NAME, HYALECTIN, FOR SODIUM HYALURONATE IN THE DEVICE DESCRIPTION; AND 2) MODIFICATIONS TO THE CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS TO ENHANCE THE APPROPRIATE USAGE OF THE DEVICE.
P890003|S133|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MODELS 8090 OR 2290 PACING SYSTEM ANALYZER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2007|01/04/2008|||OK30|MINOR CHANGES TO A WELDING PROCEDURE.
P980016|S118|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/10/2007|01/03/2008|||APPR|APPROVAL FOR MINOR DESIGN CHANGES THAT ADD ALTERNATE COMPONENTS, DIODES (XD433, XD445) AND CAPACITOR (AVX KYOCERA X5R), TO THE APPROVED DEVICE COMPONENTS FOR USE ON THE HYBRID AS WELL AS MINOR ASSOCIATED MODIFICATIONS TO THE SUBSTRATE.  THE DESIGN MODIFICATIONS ARE INTENDED TO INCREASE SUPPLY LINE ROBUSTNESS, REDUCE COMPONENT COSTS, AND IMPROVE INCOMING COMPONENT QUALITY.
P010031|S088|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/10/2007|01/03/2008|||APPR|APPROVAL FOR MINOR DESIGN CHANGES THAT ADD ALTERNATE COMPONENTS, DIODES (XD433, XD445) AND CAPACITOR (AVX KYOCERA X5R), TO THE APPROVED DEVICE COMPONENTS FOR USE ON THE HYBRID AS WELL AS MINOR ASSOCIATED MODIFICATIONS TO THE SUBSTRATE.  THE DESIGN MODIFICATIONS ARE INTENDED TO INCREASE SUPPLY LINE ROBUSTNESS, REDUCE COMPONENT COSTS, AND IMPROVE INCOMING COMPONENT QUALITY.
P040028|S003|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD|SUITE 11|SAN DIEGO|CA|92121||Sensor,electro-optical(for cervical cancer)|LUMA CERVICAL IMAGING SYSTEM|MWM|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2007|02/27/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC. IN SAN DIEGO, CALIFORNIA.
P980053|S011|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2007|01/09/2008|||OK30|CHANGE INVOLVING CERTAIN MONITORING TESTS FOR THE DEVICE.
P840064|S034|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2007|01/04/2008|||OK30|ADDITIONAL AERATION ROOM LOCATED AT STERIGENICS IN BELGIUM.
P990020|S029|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/2007|01/04/2008|||APPR|APPROVAL FOR A CHANGE TO THE PRIMARY PACKAGING FOR THE XCELERANT DELIVERY SYSTEM FOR THE ANEURX AAADVANTAGE STENT GRAFT.
P890055|S025|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2007|10/10/2008|||APPR|APPROVAL FOR: 1) A NEW MANUFACTURING FACILITY, CODMAN NEUROSCIENCES, SARL, LELOCLE, SWITZERLAND AND 2) THE ADDITIONAL DEVICE ACCESSORIES FOR THE CODMAN 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP ¿ SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950).
P910077|S083|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS ICD FAMILIES & LATITUDE COMMUNICATOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/2007|01/30/2008|||APPR|APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482) VERSION 2.1 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.40 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS (LIVIAN), MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
P010012|S166|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL 3 RF CONTAK & RENEWAL PG, LIVIAN CRT-D|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/2007|01/30/2008|||APPR|APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482) VERSION 2.1 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.40 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS (LIVIAN), MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
P960040|S156|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM & VITALITY PG CONFIENT ICD|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/2007|01/30/2008|||APPR|APPROVAL FOR THE LATITUDE COMMUNICATOR SOFTWARE (MODEL 6482) VERSION 2.1 AND RELATED SYSTEM SOFTWARE (MODEL 6488) THAT CONTAINS REGULATED APPLICATION SERVER (RAS) SOFTWARE VERSION 2.40 AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO SUPPORT NEW DEVICE MODELS (LIVIAN), MAKE MINOR SOFTWARE CORRECTIONS, AND IMPROVE EASE OF USE WITH THE LATITUDE SYSTEM.
P890047|S021|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2007|01/04/2008|||OK30|ADDITIONAL AERATION ROOM LOCATED AT STERIGENICS IN BELGIUM.
P050007|S007|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2007|01/11/2008|||OK30|ADDITION OF A STEP TO THE MANUFACTURING PROCESS TO IMPLEMENT HEAT FORMING AT THE PUSHER BODY/ OBTRUATOR SHAFT JOINT FOR THE DEVICE.
P980022|S022|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS)|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2007|01/11/2008|||OK30|CHANGES IN THE MANUFACTURING PROCESS INCLUDING REPLACEMENT OF CENTRIFUGATION OF GLUCOSE OXIDASE WITH FILTRATION, AND INCORPORATION OF KEYPAD OVERLAY WITH A NEW ADHESIVE.
P010013|S019|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2007|02/01/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORPORATION, MARLBOROUGH, MASSACHUSETTS.
P050012|S013|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2007|01/11/2008|||OK30|ADDITION OF A SUPPLIER FOR THE DEXCOM SENSOR SUB-ASSEMBLIES.
P050049|S002|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM HBSAG|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/13/2007|12/19/2007|||APPR|APPROVAL FOR LABELING MODIFICATIONS THAT CLARIFIES THE MEANING OF THE FINAL INTERPRETATION REPEAT REACTIVE, NONCONFORMING FOR HBSAG IN THE AXSYM HBSAG CONFIRMATORY PACKAGE INSERT.  ALSO, CHANGES TO THE AXSYM HBSAG PACKAGE INSERT TO ALIGN WITH THE REMOVAL OF THE TERM "REPEAT REACTIVE" FROM THE INTERPRETATION OF RESULTS FOR THE AXSYM HBSAG CONFIRMATORY ASSAYS.
P910023|S164|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2007|01/11/2008|||OK30|ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE CIRCUIT BOARD ASSEMBLY.
P030054|S076|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2007|01/11/2008|||OK30|ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE CIRCUIT BOARD ASSEMBLY.
P980022|S023|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2007|07/17/2008|||APPR|APPROVAL FOR AN UPDATE OF SOFTWARE USED IN MODEL MMT 512 AND MMT 712 INSULIN PUMPS TO VERSION 2.2A.
P920004|S021|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||Device, hemostasis, vascular|VASOSEAL|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2007|01/11/2008|||OK30|CHANGE TO THE SPONGE PLUG RINSE SYSTEM FROM A SEMI-AUTOMATED TO A FULLY AUTOMATED SYSTEM.
P040040|S002|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2007|01/25/2008|||OK30|APPLICANT TO BE THE PRIMARY SOURCE FOR THE LASER WELDING PROCESS, WHILE RETAINING THE CURRENT VENDOR AS A SECONDARY SOURCE.
P010068|S012|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EZ STEER 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2007|02/01/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.
P990025|S015|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER 4MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2007|02/01/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.
P950005|S024|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER 8MM AND 4MM NON-NAVIGATIONAL BI-DIRECTIONAL CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2007|02/01/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., CHIHUAHUA, MEXICO.
P960028|S026|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL IOLS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2007|01/23/2008|||OK30|CHANGE IN TUMBLING TIME FOR THE 3-PIECE ACRYLIC INTRAOCULAR LENSES.
P980040|S020|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR ACRYLIC MONOFOCAL IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2007|01/23/2008|||OK30|CHANGE IN TUMBLING TIME FOR THE 3-PIECE ACRYLIC INTRAOCULAR LENSES.
P990080|S029|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC MONOFOCAL IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2007|01/23/2008|||OK30|CHANGE IN TUMBLING TIME FOR THE 3-PIECE ACRYLIC INTRAOCULAR LENSES.
P010012|S167|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 3 FAMILY OF LEADS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2007|02/11/2008|||APPR|APPROVAL FOR REPLACEMENT OF THE CURRENT REHAU SI-1511 MEDICAL ADHESIVE IN THE LEADS WITH MED-1515 MEDICAL ADHESIVE.
P030047|S010|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE RX NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2007|01/16/2008|||OK30|CHANGE IN THE MANUFACTURING MATERIALS FOR THE PROCESSING AID, WHICH IS USED TO TACK THE SUPPORT MEMBER SLEEVE IN PLACE WHILE THE SLEEVE IS HEAT-SHRUNK OVER THE ENTIRE ASSEMBLY.
P910071|S011|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL|LWL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2007|05/20/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PHARMPUR GMBH, KONIGSBRUNN, GERMANY86343
P880091|S024|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL SILICONE UV - ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2007|01/16/2008|||OK30|REMOVAL OF A POST STERILIZATION COSMETIC LENS INSPECTION STEP.
P980022|S024|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2007|02/08/2008|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS, A DESIGN CHANGE TO THE PARADIGM REAL-TIME PUMP (MODEL MMT-522, 722), AND A CHANGE TO THE STORAGE AND SHIPPING TEMPERATURE OF THE GLUCOSE SENSOR (MMT-7002C, D, E).  SOFTWARE MODIFICATIONS INCLUDED UPDATING THE GUARDIAN REAL-TIME MONITOR (CSS7100) SOFTWARE TO VERSION 2.0A AND UPDATING THE CARELINK ONLINE (MMT-7333) SOFTWARE TO VERSION 4.1.  THE DESIGN CHANGE TO THE PARADIGM REAL TIME PUMP INVOLVES A REDESIGN OF THE MOTOR FLEX ASSEMBLY TO INCREASE DURABILITY OF THE FLEXPRINT CONNECTOR.  THE CHANGE TO THE GLUCOSE SENSOR SHIPPING AND STORAGE CONDITIONS INCLUDES AN EXPANSION OF THE TEMPERATURE RANGE TO 2-27 DEGREES C AND ALLOWS WAREHOUSE-TO-CUSTOMER SHIPPING AT NON-REFRIGERATED TEMPERATURES.  THIS DEVICE IS INTENDED TO CONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS.  THIS INFORMATION IS INTENDED TO SUPPLEMENT, NOT REPLACE, BLOOD GLUCOSE INFORMATION OBTAINED USING A STANDARD HOME GLUCOSE-MONITORING DEVICES.  THIS INFORMATION MAY ALLOW IDENTIFICATION OF PATTERNS OF GLUCOSE LEVEL EXCURSIONS ABOVE OR BELOW THE DESIRED RANGE, FACILITATING THERAPY ADJUSTMENTS WHICH MAY MINIMIZE THESE EXCURSIONS.
P010019|S008|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A & B SOFT CONTACT LENSES|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2007|02/12/2008|||APPR|APPROVAL FOR THE ADDITION OF 1% COPOLYMER 845 TO THE PACKAGING SALINE FOR LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR.
P030002|S014|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520|NAA|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/2007|06/19/2008|||APPR|APPROVAL TO MARKET THE FOLLOWING MODELS IN 0.5 DIOPTER INCREMENTS: MODELS AT-45-HD100 (10 TO 33 DIOPTERS), HD500 (17.0 TO 33.0 DIOPTERS), AND HD520 (10 TO 16.5 DIOPTERS).  ADDITIONALLY, APPROVAL TO RECOMMEND USE OF THE STAAR MSI-PR/TR AND MSI-PF/TF INJECTORS WITH MTC-60C CARTRIDGE TO DELIVER THESE LENS MODELS.
P980016|S119|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST & VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2007|01/16/2008|||OK30|CHANGES IN THE MANUFACTURING PROCESS FOR THE BOND PAD ARRAY (BPA) COMPONENTS FROM PRESS-FIT TO INSERT-MOLDED.
P010031|S089|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||ENRHYTHM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2007|01/16/2008|||OK30|CHANGES IN THE MANUFACTURING PROCESS FOR THE BOND PAD ARRAY (BPA) COMPONENTS FROM PRESS-FIT TO INSERT-MOLDED.
P980035|S084|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CONCERTO|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2007|01/16/2008|||OK30|CHANGES IN THE MANUFACTURING PROCESS FOR THE BOND PAD ARRAY (BPA) COMPONENTS FROM PRESS-FIT TO INSERT-MOLDED.
P960028|S027|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL IOLS|MFK|OP|135 Review Track For 30-Day Notice||N|12/17/2007|05/30/2008|||APPR|APPROVAL FOR A CHANGE IN THE TUMBLING/POLISHING PROCESS.
P980040|S021|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR ACRYLIC IOLS|HQL|OP|135 Review Track For 30-Day Notice||N|12/17/2007|05/30/2008|||APPR|APPROVAL FOR A CHANGE IN THE TUMBLING/POLISHING PROCESS.
P990080|S030|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC IOLS|HQL|OP|135 Review Track For 30-Day Notice||N|12/17/2007|05/30/2008|||APPR|APPROVAL FOR A CHANGE IN THE TUMBLING/POLISHING PROCESS.
P900030|S010|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN BARD COLLAGEN IMPLANT|LNM|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/2007|01/11/2008|||APPR|APPROVAL FOR UPDATED DIRECTIONS FOR USE IN ORDER TO STRENGTHEN INFORMATION ON ADVERSE EVENTS.
P040051|S001|STELKAST COMPANY|200 HIDDEN VALLEY ROAD||MCMURRAY|PA|15317||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|STELKAST SURPASS ACETABULAR SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2007|05/08/2009|||APPR|APPROVAL FOR IMPLEMENTATION OF NEW SOFTWARE TO THE MANUFACTURING LINE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF THE TWO INNER SPHERE POLISHING STATIONS, WHILE THE OTHER STATION CONTINUES TO BE USED FOR INITIAL PRODUCTION.
P030025|S052|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2007|01/17/2008|||OK30|INSTALLATION OF AN ADDITIONAL STERILIZATION CHAMBER AT ONE OF THE CURRENT CONTRACT STERILIZATION FACILITIES.
P040016|S027|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2007|01/17/2008|||OK30|INSTALLATION OF AN ADDITIONAL STERILIZATION CHAMBER AT ONE OF THE CURRENT CONTRACT STERILIZATION FACILITIES.
P850048|S023|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA IMMUNOASSAY|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2007|02/26/2008|||APPR|APPROVAL FOR REFORMULATED WASH BUFFER, WASH BUFFER II, ON THE ACCESS IMMUNOASSAY SYSTEMS.
P970038|S011|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECT FREE PSA|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2007|03/06/2008|||APPR|APPROVAL FOR A REFORMULATED WASH BUFFER, WASH BUFFER II ON THE ACCESS IMMUNOASSAY SYSTEMS.
P940040|S009|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST|MWA|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2007|08/26/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMERVILLE, NEW JERSEY FOR BULK MANUFACTURING AND FILLING OPERATIONS.
P040020|S007|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2007|02/06/2008|||OK30|ADDITION OF INFORMATION: 1) CLARIFYING THE OPTIKOS MODULATION TRANSFER FUNCTION (MTF) TEST PROCEDURE THAT WAS REVISED; 2) PROVIDING THE SUPPLEMENTARY DATA AND VALIDATION DATA FOR THE SOFTWARE OF THE OPTIKOS MTF BENCH; AND 3) PROVIDING THE SOFTWARE VALIDATION FOR THE ADDITIONAL OPTIKOS MTF SYSTEM TO TEST MULTIFOCAL LENSES.
P050007|S008|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2007|01/17/2008|||OK30|ALTERNATE METHOD OF MANUFACTURING OF THE STARCLOSE CLIP USED IN THE STARCLOSE AND STARCLOSE SE SYSTEMS.
P980037|S024|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEN|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/20/2007|06/17/2008|||APPR|APPROVAL FOR AN ALTERNATIVE HYDROPHILIC COATING MATERIAL AND SUPPLIER (DSM BIOMEDICAL, GLEEN, NETHERLANDS) USED ON THE DISTAL SHAFT OF THE SPIROFLEX FAMILY OF CATHETERS (SPIROFLEX AND SPRIOFLEX VG) AND APPROVAL TO PERFORM THE MANUFACTURING COATING PROCESS OF THE NEW DSM HYDROPHILIC COATING AT THE POSSIS FACILITY, MINNEAPOLIS, MINNESOTA.
P910023|S165|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2007|01/17/2008|||OK30|ALTERNATE SUPPLIER FOR SEVERAL COMPONENTS.
P030054|S077|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2007|01/17/2008|||OK30|ALTERNATE SUPPLIER FOR SEVERAL COMPONENTS.
P970034|S010|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2007|04/17/2008|||APPR|APPROVAL FOR A CHANGE IN LENS POLISH.
P040038|S012|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/18/2007|02/14/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P980040|S022|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1-PIECE IOL MODEL ZCB00|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2007|02/01/2008|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE AT A.M.O. PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.
P920048|S005|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|FULLTERM FETAL FIBRONECTIN TEST|LKV|CH|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2007|01/29/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORP., MARLBOROUGH, MASSACHUSETTS.
P840001|S105|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION|LGW|NE|30-Day Notice||N|12/21/2007|01/17/2008|||OK30|USE OF AN INSERT-MOLDED PROCESS TO MANUFACTURE THE BOND PAD ARRAY (BPA) IN PLACE OF A PRESS-FIT MANUFACTURING METHOD.
P970004|S047|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY|EZW|GU|30-Day Notice||N|12/21/2007|01/17/2008|||OK30|USE OF AN INSERT-MOLDED PROCESS TO MANUFACTURE THE BOND PAD ARRAY (BPA) IN PLACE OF A PRESS-FIT MANUFACTURING METHOD.
P030005|S049|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK TR 2|NKE|CV|30-Day Notice||N|12/21/2007|01/17/2008|||OK30|ADDITION OF TWO REFLOW OVENS TO THE CONTAK TR2 HYBRID SOLDER REFLOW MANUFACTURING PROCESS.
P010012|S168|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2007|01/25/2008|||OK30|ADDITION OF A SUPPLIER FOR THE THIN FILM RESISTOR CHIP COMPONENT.
P020026|S048|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM ON THE RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY S|NIQ|CV|Normal 180 Day Track No User Fee|Other Report|N|12/21/2007|10/09/2008|||APPR|APPROVAL FOR FINAL ELUTING SPECIFICATIONS.
P960040|S157|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM, PRIZM AT & VITALITY FAMILES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2007|01/25/2008|||OK30|ADDITION OF A SUPPLIER FOR THE THIN FILM RESISTOR CHIP COMPONENT.
P040002|S013|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM ANEURYSM STENT GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|02/21/2008|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS US, INC., LOS ANGELES, CALIFORNIA.
P010012|S169|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|01/25/2008|||OK30|PROCESSING OF ADDITIONAL PRODUCT ON EXISTING BONDING MACHINES.
P000012|S017|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|08/26/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., SOMERVILLE, NEW JERSEY FOR BULK MANUFACTURING AND FILLING OPERATIONS.
P960040|S158|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|01/25/2008|||OK30|PROCESSING OF ADDITIONAL PRODUCT ON EXISTING BONDING MACHINES.
P890047|S022|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/2007|11/03/2011|||APPR|APPROVAL FOR AN IMPROVED BUFFER FORMULATION AND LATEX-FREE PACKAGING CONFIGURATION FOR THE DEVICE.
P050037|S005|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2007|01/28/2008|||APPR|APPROVAL FOR THE CREATION OF A CONVENIENCE KIT AND ASSOCIATED MODIFICATIONS TO THE LABELING.
P050052|S006|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2007|01/25/2008|||APPR|APPROVAL FOR THE CREATION OF A CONVENIENCE KIT AND ASSOCIATED MODIFICATIONS TO THE LABELING.
P050010|S001|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-L TOTAL DISC REPLACEMENT|MJO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2007|01/25/2008|||APPR|APPROVAL FOR NEW POLYETHYLENE INLAYS WITH A TANTALUM RADIOGRAPHIC MARKER EMBEDDED IN THE ANTERIOR LIP OF THE INLAY.
P040002|S014|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2007|03/05/2008|||APPR|APPROVAL FOR THE REMOVAL OF THE STEEL HYPOTUBE FROM THE 21FR BIFURCATED DELIVERY SYSTEM, THE 17FR STRAIGHT DELIVERY SYSTEM, AND THE 19FR DELIVERY SYSTEM.
P910023|S166|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|01/24/2008|||OK30|CHANGES TO THE SILVER VANADIUM OXIDE (SVO) PROCESSING AND ELECTROLYTE ADDITIVE FOR BATTERIES.
P030054|S078|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|01/24/2008|||OK30|CHANGES TO THE SILVER VANADIUM OXIDE (SVO) PROCESSING AND ELECTROLYTE ADDITIVE FOR BATTERIES.
P980016|S120|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|05/16/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE VENDOR?S HYBRID TESTS.
P010031|S090|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF ICD & CONCERTO ICD|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|05/16/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE VENDOR?S HYBRID TESTS.
P980035|S085|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|05/16/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE VENDOR?S HYBRID TESTS.
P010020|S008|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|02/05/2008|||OK30|CHANGE TO THE INCOMING INSPECTION CRITERIA FOR A MATERIAL USED IN THE MANUFACTURE OF THE DEVICE.
P000053|S014|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2007|02/05/2008|||OK30|CHANGE TO THE INCOMING INSPECTION CRITERIA FOR A MATERIAL USED IN THE MANUFACTURE OF THE DEVICE.
P070001|S001|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-C TOTAL DISC REPLACEMENT|MJO|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/31/2008|04/30/2008|||APPR|APPROVAL FOR EXTENSION OF SHELF LIFE TO TWO (2) YEARS.
P870072|S039|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/2007|01/31/2008|||APPR|APPROVAL TO REVISE THE IVAD INSTRUCTIONS FOR USE TO DELETE THE REFERENCE TO PARACORPOREAL PLACEMENT OF THE IVAD AND INDICATE THAT THE IVAD SHOULD BE CONTRAINDICATED FOR THE PARACORPOREAL PLACEMENT.
P930038|S052|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/28/2007|09/26/2008|||APPR|APPROVAL FOR USE OF THE ANGIO-SEAL VASCULAR CLOSURE DEVICE IN CLOSURE OF FEMORAL VENOUS PUNCTURE SITES AND FOR THE REMOVAL OF THE PRECAUTION STATEMENT RELATING TO THE USE OF THE ANTICOAGULANT WARFARIN.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL AND FEMORAL VENOUS PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.
P030027|S004|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002|0000|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2007|05/08/2008|||APPR|APPROVAL FOR THE ADDITION OF AN AUTOMATED PROCESS TO SPECIFIC POLISHING STATIONS.
P060004|S001|Carl Zeiss Meditec, Inc.|5160 Hacienda Drive||Dublin|CA|94568||Excimer laser system|MEDITEC MEL 80 EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Change Design/Components/Specifications/Material|N|12/28/2007|03/28/2011|11M-0256|04/25/2011|APPR|APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM.  THIS DEVICE USES AN OPTICAL ZONE OF 6.0 TO 6.5 MM IN DIAMETER AND A TRANSITION ZONE OF 2.0 TO 4.0 MM FOR A TOTAL ABLATION DIAMETER OF 10.0 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY-OCCURRING HYPEROPIA OF LESS THAN OR EQUAL TO +5.0 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF > +0.5 AND <= +3.0D, WITH A MAXIMUM MRSE OF +5.0D; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION OVER THE PAST YEAR AS DEMONSTRATED BY CHANGE IN SPHERE AND CYLINDER OF <= 0.5D.
P890040|S006|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOF-FORM 55 EW AND LL-55 SOFT HYDROPHILIC SPHERICAL CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2007|03/03/2008|||APPR|APPROVAL TO BEGIN PARAMETRIC RELEASE FOR HYDROPHILIC LENSES PACKAGED IN VIALS.
P960039|S003|UNILENS CORPORATION USA|10431 72nd Street North||Largo|FL|33777||Lenses, soft contact, extended wear|SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2007|03/03/2008|||APPR|APPROVAL TO BEGIN PARAMETRIC RELEASE FOR HYDROPHILIC LENSES PACKAGED IN VIALS.
P060001|S004|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2007|01/30/2008|||OK30|USE OF AN ALTERNATE STERILIZATION CHAMBER FOR THE ABOVE LISTED PRODUCTS.
P030036|S004|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|MEDTRONIC SELECTSECURE LEAD MODEL 3830|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/2007|03/30/2011|||APPR|APPROVAL FOR IMPROVEMENTS TO THE CHEMISTRY, MANUFACTURING , AND CONTROLS (CMC) AND ELUTION METHODS AND SPECIFICATIONS FOR THE DRUG COATING ON SELECTSECURE MODEL 3830 LEADS.
P930039|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS & VITATRON|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/04/2008|02/01/2008|||OK30|TRANSFER OF MANUFACTURING FOR THE MOLDED SILICONE COMPONENT TO AN OUTSIDE SUPPLIER.
P010012|S170|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL & VITALITY FAMILY OF ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2008|02/06/2008|||OK30|MODIFICATION OF TRANSFORMER MANUFACTURING PROCESS.
P960040|S159|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL & VITALITY FAMILY OF ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2008|02/06/2008|||OK30|MODIFICATION OF TRANSFORMER MANUFACTURING PROCESS.
P950037|S056|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SELOX ST/JT, SETROX S & DEXTRUS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2008|02/29/2008|||APPR|APPROVAL FOR LEAD SUTURE SLEEVE DESIGN CHANGES, DOWNSIZED PACEMAKER SHIPPING BOXES, AND USE OF NON-LINGUAL SYMBOLS ON PACEMAKER LABELING.
P980023|S030|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX SD, TD & S/T|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2008|02/29/2008|||APPR|APPROVAL FOR LEAD SUTURE SLEEVE DESIGN CHANGES, DOWNSIZED PACEMAKER SHIPPING BOXES, AND USE OF NON-LINGUAL SYMBOLS ON PACEMAKER LABELING.
P020004|S033|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2008|02/07/2008|||OK30|CHANGE IN CUFF CONTAMINATION INSPECTION CRITERIA FOR THE DEVICE.
P040043|S021|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2008|02/07/2008|||OK30|CHANGE IN CUFF CONTAMINATION INSPECTION CRITERIA FOR THE DEVICE.
P000032|S024|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2008|02/04/2008|||OK30|CHANGE TO A DISPOSABLE PROBE FOR THE DEVICE.
P050011|S001|BAXTER HEALTHCARE CORP.|1620 WAUKEGAN ROAD||MCGAW PARK|IL|60085||BARRIER, ABSORABLE, ADHESION|ADEPT ADHESION REDUCTION SOLUTION|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2008|02/07/2008|||OK30|RELOCATION OF THE QUALITY SYSTEM TO BAXTER AG, VIENNA, AUSTRIA AND CHANGING THE CONTRACT TEST LABORATORY TO THE MATERIAL MANUFACTURER CARGILL?S TESTING LABORATORY.
P970008|S035|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/09/2008|03/07/2008|||APPR|APPROVAL FOR COMPONENT CHANGES TO THE MICROWAVE GENERATOR SUBASSEMBLY USED IN THE TARGIS SYSTEM CONTROL UNIT MODEL 4000 AND IN THE COOLWAVE CONTROL UNIT MODEL 5000.
P040024|S017|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2008|03/07/2008|||OK30|ELIMINATION OF HIGH DIFFERENTIAL PRESSURE WARNING LIMITS FOR CLEAN ROOMS USE DIN THE MANUFACTURE OF THE DEVICE.
P810046|S225|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER RX CORONARY DILATATION CATHETER|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2008|02/08/2008|||OK30|CHANGE IN E-BEAM IRRADIATION EQUIPMENT.
P030009|S018|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER OVER THE WIRE (OTW) & DRIVER MULTI-EXCHANGE (MX) CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2008|02/13/2008|||OK30|INCREASING THE MARKER BAND SPACING OF THE STENT INNER SUB-ASSEMBLY BY 0.5 MM FOR THE 24 MM AND 3 MM STENT LENGTHS OF THE DEVICES.
P950029|S033|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY & ELA RHAPSODY PACEMAKERS|NVZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2008|02/13/2008|||APPR|APPROVAL FOR AN ADDITION INSPECTION STEP TO WEIGH THE FINAL DEVICE AFTER MANUFACTURING OF THE DEVICES.
P830055|S101|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/14/2008|03/13/2008|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE EXISTING LCS COMPLETE RPS FEMORAL COMPONENTS: 1) CHANGES TO INCLUDE MINOR DIMENSIONAL AND TOLERANCE CHANGES; 2) THE DESCRIPTION OF THE DEVICE WILL CHANGE TO LCS COMPLETE RPS FLEXION; AND3) ADDITIONAL LABELING FOR USE IN PATIENTS REQUIRING A HIGHER THAN NORMAL DEGREE OF FLEXION.
P010031|S091|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2008|08/18/2008|||APPR|APPROVAL FOR CHANGING THE LASER RIBBON BONDING PROCESS.
P000058|S028|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2008|12/04/2008|||APPR|APPROVAL FOR A CHANGE IN THE SPECIFIC ACTIVITY SPECIFICATION RANGE OF DIBOTERMIN ALFA DRUG SUBSTANCE AND DRUG PRODUCT.
P000054|S017|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2008|12/04/2008|||APPR|APPROVAL FOR A CHANGE IN THE SPECIFIC ACTIVITY SPECIFICATION RANGE OF DIBOTERMIN ALFA DRUG SUBSTANCE AND DRUG PRODUCT.
P050053|S006|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2008|12/04/2008|||APPR|APPROVAL FOR A CHANGE IN THE SPECIFIC ACTIVITY SPECIFICATION RANGE OF DIBOTERMIN ALFA DRUG SUBSTANCE AND DRUG PRODUCT.
P980016|S121|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2008|08/18/2008|||APPR|APPROVAL FOR CHANGING THE LASER RIBBON BONDING PROCESS.
P890055|S026|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2007|12/17/2010|||APPR|APPROVAL FOR MEDSTREAM PROGRAMMABLE INFUSION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION (5.0 PH TO 7.0 PH) IN THE TREATMENT OF SEVERE SPASTICITY.
P050023|S009|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX VR/DR/HF (-T) ICD'S & CRT-D'S|MRM|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2008|03/10/2008|||APPR|APPROVAL FOR CHANGES TO: 1) GEOMETRICAL DIMENSIONS OF THE FLANGE OF THE FEEDTHROUGH; AND 2) INSULATING GLASS TYPE 8455 HAS BEEN REPLACED BY GLASS TYPE 8250.
P000009|S025|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S|MRM|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2008|03/10/2008|||APPR|APPROVAL FOR CHANGES TO: 1) GEOMETRICAL DIMENSIONS OF THE FLANGE OF THE FEEDTHROUGH; AND 2) INSULATING GLASS TYPE 8455 HAS BEEN REPLACED BY GLASS TYPE 8250.
P950022|S050|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|DURATA LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2008|02/14/2008|||OK30|ALTERNATE METHOD FOR ATTACHING THE DISTAL TIP.
P000029|S035|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2008|02/13/2008|||OK30|CHANGE IN SUPPLIER OF A REAGENT USED IN ENDOTOXIN TESTING.
P960011|S013|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2008|02/29/2008|||OK30|CHANGE IN THE STERILIZATION CYCLE.
P930014|S023|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENS (IOL)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2008|03/11/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE ACRYSOF INTRAOCULAR LENS (IOL) CASE (#79 AND #80) DRAINAGE FEATURES.
P040020|S008|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF INTRAOCULAR LENSES|MFK|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2008|03/11/2008|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE ACRYSOF INTRAOCULAR LENS (IOL) CASE.
P030005|S050|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR/TR2 FAMILY OF PACEMAKERS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2008|03/18/2008|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE SURGE SUPPRESSOR FOR THE DEVICES.
P990020|S030|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2008|02/15/2008|||OK30|ADDITIONAL SUPPLIER OF FINISHED PEANUT STENTS.
P960030|S020|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|ISOFLEX OPTIM LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/17/2008|03/18/2008|||APPR|APPROVAL FOR DEVICE MODIFICATIONS TO THE ISOFLEX OPTIM FAMILY OF LEADS.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ISOFLEX OPTIM MODEL 1944T AND ISOFLEX OPTIM 1948T.
P960040|S160|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY & VITALITY 2 DEVICE FAMILY|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/17/2008|02/13/2008|||APPR|APPROVAL TO ADD WARNING INFORMATION REGARDING CORRECT DEVICE IMPLANT ORIENTATION TO THE LABELING OF THE DEVICES.
P000029|S036|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2008|02/13/2008|||OK30|CHANGES TO A CLEANING DEVICE USED IN THE PRODUCTION OF THE DEVICE.
P810031|S035|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON, HEALON GV & HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2008|08/01/2008|||APPR|APPROVAL FOR A NEW CONTRACT STERILIZER FOR SECONDARY PACKAGING.
P050053|S007|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2008|02/14/2008|||OK30|CHANGE IN TEST METHODOLOGY FOR THE DEVICE.
P040052|S006|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|MONOPREP PAP TEST|MKQ|PA|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/18/2008|07/09/2008|||APPR|APPROVAL FOR LABELING CHANGES BASED ON THE ANALYSIS OF DATA FROM THE POST-MARKET STUDY ENTITLED SURE (SPECIMEN UNSAT RATE EVALUATION).  THESE CHANGES HAVE BEEN INCORPORATED INTO THE LABORATORY INFORMATION AND INSTRUCTIONS LABELING.
P060004|S002|Carl Zeiss Meditec, Inc.|5160 Hacienda Drive||Dublin|CA|94568||Excimer laser system|MEL 80 EXCIMER LASER SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2008|02/14/2008|||OK30|CHANGE REGARDING AN ALTERNATE LASER SOURCE.
P010032|S024|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ANS GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/2008|02/07/2008|||APPR|APPROVAL FOR CHANGES TO THE LABELING FOR THE QUIKLINK CONTROLLER, MODEL 3860.
P880086|S159|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY, IDENTITY, INTEGRITY & VICTORY/ZEPHYR FAMILY OF DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2008|02/20/2008|||OK30|ALTERNATE MEDICAL ADHESIVE FOR SEALING THE PACER HEADER SEPTUM BORE.
P020018|S025|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH ENDOVASCULAR GRAFT|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2008|06/19/2008|||APPR|APPROVAL FOR A CHANGE FROM AN OXYFUME BLEND ETHYLENE OXIDE (ETO) STERILANT TO THE USE OF 100% ETO STERILANT IN THE CURRENT STERILIZATION CYCLE FOR THE ZENITH FAMILY OF DEVICES AND THE ADDITION OF A SUPPLIER OF THE STERILANT.
P930038|S054|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2008|03/18/2008|||APPR|APPROVAL FOR DEVICE MODIFICATIONS TO THE ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE INCLUDING UTILIZING AN AUTOMATED COLLAGEN COMPACTION MECHANISM FOR EASE OF USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.
P990052|S019|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE EAR IMPLANT SYSTEM|MPV|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2008|03/25/2008|||APPR|APPROVAL FOR A MINOR SOFTWARE CHANGE TO THE CURRENTLY APPROVED SYMFIT MODULE AND IS INDICATED FOR ADULTS, 18 YEARS OF AGE OR OLDER, WHO HAVE A MODERATE TO SEVERE SENSORINEURAL HEARING LOSS.  PRIOR TO RECEIVING THE DEVICE, IT IS RECOMMENDED THAT AN INDIVIDUAL HAVE EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
P040027|S010|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|135 Review Track For 30-Day Notice||N|01/22/2008|05/29/2008|||APPR|APPROVAL FOR: 1) A CHANGE IN THE TYPE OF COOLING GAS; 2) A CHANGE IN THE APPLICATION OF THE COOLANT; AND 3) THE ADDITION OF A TEMPERATURE CONTROLLER.
P040037|S009|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2008|05/29/2008|||APPR|APPROVAL FOR: 1) A CHANGE IN THE TYPE OF COOLING GAS; 2) A CHANGE IN THE APPLICATION OF THE COOLANT; AND 3) THE ADDITION OF A TEMPERATURE CONTROLLER.
P000025|S031|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED EL C40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2008|04/18/2008|||OK30|MODIFICATIONS AS FOLLOWS: 1) ADAPTION OF ENCLOSED TESTS AT HEADER INCOMING INSPECTION; 2) CHANGE IN INCOMING INSPECTION PROCEDURE FOR CABLES OF REMOTE BATTERY PACK; 3) INTRODUCTION OF SILICONE MIXING MACHINE; 4)CHANGE IN MANUFACTURING PROCEDURE FOR WELDING OF COIL; 5) ALTERNATIVE EQUIPMENT TO MEASURE STRENGTH OF MAGNETS; 6) CHANGES TO ELECTRODE MOULDS; 7) CHANGE IN SPRINT; AND 8) NEW MOULD SHAPE.
P970003|S096|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/23/2008|02/22/2008|||APPR|APPROVAL FOR LABELING CHANGES TO THE DEMIPULSE AND PULSE DUO GENERATOR, MODELS 103 AND 104 WHICH PROVIDE INSTRUCTIONAL STEPS IN THE EVENT THAT THE USER ENCOUNTERS A MESSAGE THAT THE PULSE GENERATOR IS CURRENTLY DISABLED.
P030024|S008|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2008|02/20/2008|||OK30|INTRODUCTION OF A NEW PIECE OF AUTOMATED EQUIPMENT THAT REPLACES A MANUAL ASSEMBLY OPERATION.
P010012|S171|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL RF HEART FAILURE PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2008|02/25/2008|||OK30|USE OF THE EXISTING INNER LEAD BONDING (ILB) MACHINES TO PROCESS THE INSIGNIA MIXED MODE TAB AND THE RENEWAL RF ANALOG TAB.
P000007|S014|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/24/2008|12/12/2008|||APPR|APPROVAL FOR UPDATED LABELING BASED ON THE POST APPROVAL STUDY.
P990075|S019|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/2008|07/28/2008|||APPR|APPROVAL FOR A NEW STANDARD AND MICRO INJECTION DOME (PORT) TEMPORARY USE ACCESSORY COMPONENT.
P050023|S010|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS AND CRT-DS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2008|02/08/2008|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR DISCRETE COMPONENTS OF THE ELECTRONIC MODULE INCLUDING THE HIGH VOLTAGE POWER TRANSFORMER, PULSE TRANSFORMERS, AND MCM-MULTI CHIP MODULES.
P890003|S134|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK PROGRAMMER, MODEL 2090|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE MATERIAL USED FOR A PRINTED CIRCUIT BOARD.
P980016|S122|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS, MAXIMO, INTRINSIC FAMILY, ONYX, VIRTUOSO, ENTRUST FAMILY,|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
P850051|S067|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|PREVAIL|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
P890003|S136|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
P970012|S033|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR, KAPPA 400 SR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
P980035|S086|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700/600,650,800/900 FAMILY, SIGMA FAMILY, MEDTRONIC 350 SERIES, ENPILSE 2 FAMILY ENRHYTHM, ADAPTA/VERSA/SESIA FAM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
P990001|S035|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C-SERIES DEVICES AND T-SERIES DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
P010015|S037|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC PULSE GENERATOR, INSYNC 3 PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
P010031|S092|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC MARQUIS, INSYNC 2 & 3 MARQUIS, INSYNC 2 &3 PROTECT INSYNC SENTRY FAMILY, INSYNC MAXIMO FAMILY, CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2008|02/21/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
P960028|S028|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|CHANGE IN THE ACRYLIC SHEET CASTING PROCESS.
P960016|S022|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2008|02/22/2008|||APPR|APPROVAL FOR THE LIVEWIRE TC EXTENSION CABLE A402580 AND LIVEWIRE TC EXTENSION CABLE A402581.
P050045|S001|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion|TOP2A FISH PHARMDX KIT|NXG|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2008|02/13/2008|||APPR|APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES AND ADJUSTMENT OF THE CONCENTRATION OF THE TOP2A GENE TARGETED DNA PROBES IN VIAL 3 PROBE MIX.
P980022|S025|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP|MDS|CH|30-Day Notice||N|01/28/2008|02/21/2008|||OK30|CHANGE FOR MINOR MODIFICATIONS TO DEVICE COMPONENTS.
P980037|S025|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-SPIROFLEX VG THROMBECTOMY SET|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2008|03/28/2008|||APPR|APPROVAL FOR THE SPIROFLEX VG THROMBECTOMY SET.
P960028|S029|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|MODEL SA40N ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|CONSOLIDATION OF ATTRIBUTE AND VARIABLE INSPECTIONS BY USING CERTIFIED AND CALIBRATED GO/NO-GO OVERLAYS.
P880081|S036|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|CONSOLIDATION OF ATTRIBUTE AND VARIABLE INSPECTIONS BY USING CERTIFIED AND CALIBRATED GO/NO-GO OVERLAYS.
P050037|S006|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|NEW SUPPLIER MANUFACTURING SITE IN WHICH SOME MANUFACTURING PROCESS WILL OCCUR BEFORE MOVING TO ANOTHER FACILITY FOR FURTHER PRODUCTION.
P050052|S007|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|NEW SUPPLIER MANUFACTURING SITE IN WHICH SOME MANUFACTURING PROCESS WILL OCCUR BEFORE MOVING TO ANOTHER FACILITY FOR FURTHER PRODUCTION.
P000039|S024|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND MULTI-FENESTRATED SEPTAL OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|CHANGE TO THE LAL SAMPLE SIZE AND THE ADDITION OF A LARGER STERILIZATION CHAMBER.
P020024|S018|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|CHANGE TO THE LAL SAMPLE SIZE AND THE ADDITION OF A LARGER STERILIZATION CHAMBER.
P040040|S003|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|CHANGE TO THE LAL SAMPLE SIZE AND THE ADDITION OF A LARGER STERILIZATION CHAMBER.
P030025|S053|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|LIBERTE CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|REMOVAL OF THE REJECT CRITERIA FOR PROXIMAL WELD CREASE.
P020009|S041|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|REMOVAL OF THE REJECT CRITERIA FOR PROXIMAL WELD CREASE.
P040016|S028|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|TAXUS? EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|REMOVAL OF THE REJECT CRITERIA FOR PROXIMAL WELD CREASE.
P860019|S222|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK2 MONORAIL AND MAVERICK OTW PTCA CATHETER, QUANTUM MAVERICK PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2008|02/27/2008|||OK30|REMOVAL OF THE REJECT CRITERIA FOR PROXIMAL WELD CREASE.
P060037|S001|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE KNEE SYSTEMS|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2008|02/28/2008|||OK30|CHANGE IN THE GAMMA STERILIZATION DOSE SUBSTANTIATION METHOD.
P890064|S020|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE2|MAQ|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2008|08/12/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TURNER BIOSYSTEMS IN SUNNYVALE, CALIFORNIA, TO MANUFACTURE THE DML 3000¿ MICROPLATE LUMINOMETER WHICH IS INTENDED FOR USE WITH THE HYBRID CAPTURE 2 HIGH RISK HPV DNA TEST AND HYBRID CAPTURE 2 HPV DNA TEST.
P040001|S009|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM|NQO|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2008|07/09/2008|||APPR|APPROVAL FOR THE REVISION OF THE PHYSICIAN GUIDES AND INSTRUCTIONS FOR USE TO CLARIFY THE CONDITIONS UNDER WHICH THE X-STOP MAY BE RE-STERILIZED AND TO PROVIDE REVISED AND MORE DETAILED INSTRUCTIONS REGARDING ATTACHMENT OF THE WING ASSEMBLY TO THE SPACER ASSEMBLY.
P860022|S057|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens,contact(rigid gas permeable)-extended wear|BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS|MWL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2008|02/21/2008|||APPR|APPROVAL FOR WET SHIPPING, WITH STORAGE UP TO 30 DAYS, OF THE BOSTON EQUALENS, EQUALENS II AND BOSTON ORTHOKERATOLOGY SHAPING RIGID GAS PERMEABLE CONTACT LENSES IN BOSTON SIMPLUS MULTI-ACTION SOLUTION.
P010062|S006|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT|NUU|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2008|02/21/2008|||APPR|APPROVAL FOR WET SHIPPING, WITH STORAGE UP TO 30 DAYS, OF THE BOSTON EQUALENS, EQUALENS II AND BOSTON ORTHOKERATOLOGY SHAPING RIGID GAS PERMEABLE CONTACT LENSES IN BOSTON SIMPLUS MULTI-ACTION SOLUTION.
P970008|S036|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/31/2008|03/31/2008|||APPR|APPROVAL FOR CHANGES TO THE MATERIALS, COLOR, ANTENNA DESIGN, COOLANT PATH FUNCTIONS AND DESIGN OF THE COOLED THERMOCATH CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CTC ADVANCE AND IS INDICATED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 3.5 ? 5.0 CM (MODEL NUMBER TC1121C) OR 4.5+ CM (MODEL NUMBER TF1221C).
P880086|S160|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SJM PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2008|07/31/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, ARECIBO, PUERTO RICO.
P030035|S039|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|SJM PACEMAKERS|NKE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2008|07/31/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, ARECIBO, PUERTO RICO.
P960013|S037|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL FAMILY F LOW VOLTAGE LEADS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2008|07/31/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, ARECIBO, PUERTO RICO.
P960030|S021|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|SJM LEADS|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2008|07/31/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, ARECIBO, PUERTO RICO.
P950022|S051|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA FAMILY OF HIGH VOLTAGE LEADS|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2008|07/31/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, ARECIBO, PUERTO RICO.
P030054|S079|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE AND QUICKFLEX FAMILY OF LEADS|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2008|07/31/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, ARECIBO, PUERTO RICO.
P870077|S026|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP|DYE|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2008|01/23/2009|||APPR|APPROVAL FOR UPDATED LABELING TO THE INSTRUCTIONS FOR USE.
P970003|S097|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2008|02/29/2008|||OK30|ADDITION OF A PULSE GENERATOR SOFTWARE COMMUNICATION FLASH LOADER (CFL) TO THE MANUFACTURING PROCESS OF THE DEMIPULSE (MODEL 103) AND DEMIPULSE DUO PULSE (MODEL 104) PULSE GENERATORS.
P000014|S016|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI HB-S QUANTITATIVE REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2008|02/20/2008|||OK30|INTRODUCTION OF A NEW PIECE OF AUTOMATED EQUIPMENT THAT REPLACES A MANUAL ASSEMBLY OPERATION.
P000044|S017|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2008|02/20/2008|||OK30|NEW PIECE OF AUTOMATED EQUIPMENT THAT REPLACES A MANUAL ASSEMBLY OPERATION.
P010021|S012|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2008|02/20/2008|||OK30|INTRODUCTION OF A NEW PIECE OF AUTOMATED EQUIPMENT THAT REPLACES A MANUAL ASSEMBLY OPERATION.
P950014|S026|Urologix, Inc.|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX PROSTATRON SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/2008|07/16/2008|||APPR|APPROVAL FOR DESIGN MODIFICATIONS WHICH INCLUDE A NEW CATHETER TIP MATERIAL, RED MARK ADHESIVE, BONDING ADHESIVES, INJECTION MOLD FOR MANUFACTURING THE CATHETER TIP, AND A NEW STERILE BALLOON INFLATION STOPCOCK.  THE PRODUCTION OF THE PROSTAPROBE TYPE II, SILICONE, BLUE TREATMENT CATHETER (PART NUMBER 410053-004) WILL BE MANUFACTURED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA.
P070012|S001|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|STENT, CAROTID|MEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2008|03/06/2008|||OK30|CHANGE BY THE VENDOR OF THE EXPONENT RX PACKAGING HEADER POUCH TO THE EQUIPMENT USED TO PRODUCE THE VENDOR-SUPPLIED SEALS.
P020014|S015|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/04/2008|06/10/2008|||APPR|APPROVAL FOR LABELING CHANGES REGARDING CONCOMITANT ESSURE AND ENDOMETRIAL ABLATION PROCEDURES.
P950037|S057|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS MODELS OF PHILOS/PHILOS, AXIOS, PROTOS PULSE GENERATOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/04/2008|07/11/2008|||APPR|APPROVAL FOR A LARGER OI-CIRCUIT CAPACITOR AND MODIFICATION TO THE CERAMIC FEEDTHROUGH.
P970003|S098|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY DEMIPULSE & DEMIPULSE DUO GENERATORS|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2008|04/03/2008|||APPR|APPROVAL FOR TWO CHANGES TO HE PULSE GENERATOR SOFTWARE TO ELIMINATE A RARE TIMING CONDITION THAT MAY CAUSE THE SOFTWARE WATCHDOG TO, AT THE END OF A MAGNET-INITIATED BURST, REPORT AN ERROR EVEN THOUGH NO SUCH ERROR OCCURRED.
P020001|S005|NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|STAN S31 FETAL HEART MONITOR|HEO|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2008|03/12/2008|||APPR|APPROVAL FOR A CHANGE TO THE PATIENT INTERFACE BOX AND CABLES.
P910023|S167|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2008|03/06/2008|||OK30|ALTERNATE SUPPLIERS FOR TWO COMPONENTS.
P030054|S080|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2008|03/06/2008|||OK30|ALTERNATE SUPPLIERS FOR TWO COMPONENTS.
P000039|S025|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER & AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER-CRIBRIFORM|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2008|03/05/2008|||OK30|MODIFICATION OF THE TYVEK POUCH SEALING PARAMETERS.
P020024|S019|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2008|03/05/2008|||OK30|MODIFICATION OF THE TYVEK POUCH SEALING PARAMETERS.
P040040|S004|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULSR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2008|03/05/2008|||OK30|MODIFICATION OF THE TYVEK POUCH SEALING PARAMETERS.
P030047|S011|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL STENT SYSTEM & RX NITINOL STENT & PRO RX NITINOL STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2008|09/30/2008|||APPR|APPROVAL FOR REDUCING THE SAMPLE SIZE FOR THE FOLLOWING PROCESSES: 1) THE FUSING OPERATION FOR ALL PRECISE DEVICES AND THE SEALING OPERATION FOR PRECISE RX; AND 2) THE BONDING PROCESS OF THE PRECISE RX AND PRECISE PRO RX SUPPORT MEMBER/WIRE LUMEN SUBASSEMBLY.
P000032|S025|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2008|07/16/2008|||APPR|APPROVAL FOR THE TRANSFER OF THE DEWAR ASSEMBLY COMPONENT PROCUREMENT, INCOMING RECEIVING AND INSPECTION, AND SUB-ASSEMBLY ACTIVITIES, INCLUDING MACHINE GRIND AND NITROGEN TESTING, FROM AMERICAN MEDICAL SYSTEMS TO JOINING TECHNOLOGIES.
P030054|S081|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS HF FAMILY OF CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2008|03/06/2008|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE CONTROLLER INTEGRATED CIRCUIT CHIPS USED IN THE CURRENT ICD AND PROMOTE CRT-D DEVICES.
P910023|S168|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2008|03/06/2008|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE CONTROLLER INTEGRATED CIRCUIT CHIPS USED IN THE CURRENT ICD AND PROMOTE CRT-D DEVICES.
P030022|S009|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2008|07/02/2008|||APPR|APPROVAL FOR A CHANGE BY THE CONTRACT MANUFACTURER IN THE MANUFACTURING PROCESS: IMPLEMENTATION OF NEW SOFTWARE TO THE MANUFACTURING LINE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF THE TWO INNER SPHERE POLISHING STATIONS, WHILE THE OTHER STATION CONTINUES TO BE USED FOR INITIAL PRODUCTION.
P030047|S012|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2008|09/10/2008|||APPR|APPROVAL FOR A CHANGE TO THE INCOMING INSPECTION SPECIFICATIONS FOR THE RAW MATERIAL USED FOR THE HYPOTUBE COMPONENT.
P000020|S011|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|SCORPION  & SCORPION  M ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2008|03/13/2008|||APPR|APPROVAL FOR THE ADDITION OF A CATHETER WITH A TABBED THUMBWHEEL.
P040024|S018|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|135 Review Track For 30-Day Notice||N|02/07/2008|08/06/2008|||APPR|APPROVAL FOR A CHANGE IN TEST METHOD FOR HYALURONIC ACID AND GEL CONTENT USED IN THE MANUFACTURING OF THE DEVICE.
P010012|S172|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2008|02/25/2008|||OK30|ADDITION OF AN INSPECTION.
P980043|S016|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2008|07/01/2008|||APPR|APPROVAL TO REPLACE THE INSPECTION OF SUB-ASSEMBLIES WITH PROCESS MONITORING.
P990064|S023|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2008|07/01/2008|||APPR|APPROVAL TO REPLACE THE INSPECTION OF SUB-ASSEMBLIES WITH PROCESS MONITORING.
P000029|S037|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2008|03/07/2008|||OK30|MODIFICATIONS TO THE MANUFACTURING FACILITY (CLEAN ROOM) AND EQUIPMENT UPGRADES.
P040043|S022|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2008|03/13/2008|||OK30|ADDITION OF AN IN-PROCESS INSPECTION STEP UTILIZING AN AIR LEAK DETECTOR.
P000029|S039|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2008|03/11/2008|||OK30|CHANGE TO THE CONTROL SYSTEM REVIEW FREQUENCY AND THE USE OF COMPRESSED AIR IN THE WATER SYSTEM.
P980049|S029|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR 6250 & DR 6550 ICDS|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2008|12/05/2008|||APPR|APPROVAL FOR A CHANGE IN THE LOT ACCEPTANCE LIFE TEST.
P970008|S037|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2008|03/10/2008|||APPR|APPROVAL FOR MODIFICATIONS TO IMPROVE SYSTEM AIRFLOW AND TO IMPROVE REGULATION OF THE POWER SUPPLY.
P970027|S006|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT AXSYM ANTI-HCV|MZO|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/2008|02/22/2008|||APPR|APPROVAL FOR LABELING MODIFICATIONS THAT CORRECT THE ERROR IN THE AXSYM ANTI-HCV PACKAGE INSERT (LIST NUMBER 5C36) UNDER REATENTS SECTION.  THE MINIMUM CONCENTRATION OF ?% SOLIDS? FOR THE RECOMBINANT HCV ANTIGEN COATED MICROPARTICLES OF THE AXSYM ANTI-HCV REAGENT PACK IS BEING CHANGED FROM ?0.05%? TO ?0.04%? TO ALIGN WITH CURRENT MANUFACTURING PROCESS.
P810046|S226|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER NC CORONARY DILATATION CATHETER|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2008|08/21/2008|||APPR|APPROVAL FOR THE VOYAGER NC CORONARY DILATATION CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER NC CORONARY DILATATION CATHETER AND IS INDICATED FOR: 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS OF THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION; 3) BALLOON DILATATION OF A STENT AFTER IMPLANTATION.
P040037|S010|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2008|03/14/2008|||OK30|USE OF AN ALTERNATE MODEL OF BONDING OVEN FOR ATTACHING THE STENT TO THE GRAFT TO CONSTRUCT THE ENDOPROSTHESIS.
P030006|S017|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/2008|05/18/2009|||APPR|APPROVAL FOR A RECTAL TEMPERATURE MONITOR WHICH IS DISPOSABLE.  THE DISPOSABLE RECTAL TEMPERATURE MONITOR WILL BE CONTRACT MANUFACTURED AT PHILLIPS PLASTIC CORPORATION, SHORT-RUN FACILITY (PHILLIPS SHORT-RUN) LOCATED IN RICHMOND, WISCONSIN.
P910023|S169|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2008|03/11/2008|||APPR|APPROVAL FOR THE ADDITION OF A MANUFACTURING INSPECTION STEP TO VERIFY BATTERY PIN PLACEMENT.
P030054|S082|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY OF CRT-DS|NIK|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2008|03/11/2008|||APPR|APPROVAL FOR THE ADDITION OF A MANUFACTURING INSPECTION STEP TO VERIFY BATTERY PIN PLACEMENT.
P980049|S030|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR & DR ICDS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2008|03/20/2008|||OK30|CHANGE FOR THE KMOS (T267), THE INTEGRATED CIRCUIT, REWORK PROCESS.
P040037|S011|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2008|03/20/2008|||OK30|USE OF AN ALTERNATE ANNEALING OVEN RACK AND QUENCH TANK.
P980049|S031|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR & DR ICDS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2008|03/20/2008|||OK30|ADDING A SECOND SUPPLIER FOR HYBRID MODULES USED IN THE MANUFACTURE OF THE DEVICE.
P980049|S032|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR & DR ICDS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2008|03/20/2008|||OK30|CHANGE IN THE CUTTING HYBRID PADS MANUFACTURING PROCEDURE.
P980049|S033|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR & DR ICDS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2008|03/20/2008|||OK30|CHANGE INVOLVING THE GLUING PROCESS BETWEEN THE CAP AND THE CONNECTOR OF THE DEVICE.
P880086|S161|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY, INTEGRITY, VERITY, VICTORY, AND ZEPHYR FAMILIES OF PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2008|04/04/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO, FOR FINAL MANUFACTURING OPERATIONS, EXCLUDING STERILIZATION.
P030035|S040|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER AND FRONTIER II FAMILIES OF PACEMAKERS|NKE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2008|04/04/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO, FOR FINAL MANUFACTURING OPERATIONS, EXCLUDING STERILIZATION.
P950020|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON MONORAIL (MR), FLEXTOME CUTTING BALOON OTW, CUTTING BALLOON ULTRA2 MR/OTW|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2008|03/20/2008|||OK30|CHANGES TO THE BIOBURDEN SAMPLING PLANS.
P010030|S010|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/19/2008|04/17/2008|||APPR|APPROVAL FOR A SOFTWARE CHANGE (VERSION 4.1) TO MAKE THE THERAPY ELECTRODE (TE) FALLOFF DETECTION MORE SPECIFIC.
P050053|S008|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2008|05/13/2008|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO ADDRESS WARNINGS ABOUT IMPROPER PREPARATION OF INFUSE BONE GRAFT AND OVERFILLING OF BONE DEFECTS.
P880003|S094|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|FIRE STAR RX PTCA & DURA STAR RX PTCA BALLOON DILATATION CATHETER|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|04/15/2008|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCESS TO  ADDRESS THE POTENTIAL FOR SLOW OR NO DEFLATION OF THE FIRE STAR RX PTCA BALLOON DILATATION CATHETER AND DURA STAR? RX PTCA BALLOON DILATATION CATHETER.
P000057|S004|INTEGRA LIFESCIENCES CORPORATION|8900 CAMERON ROAD||AUSTIN|TX|78754||Finger semi-constrained pyrolytic carbon uncemented prosthesis|ASCENSION ORTHOPEDICS MCP|NEG|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/19/2008|04/24/2008|||APPR|APPROVAL TO ADD A HYDROXYAPATITE (HA) COATING TO TE STEM OF THE ASCENSION MCP PROXIMAL AND DISTAL COMPONENTS.
P990009|S022|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2008|03/20/2008|||OK30|REPLACEMENT OF AN EXISTING THROMBIN COMPONENT ENVELOPE WITH A THROMBIN COMPONENT TRAY.
P950027|S011|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN|MOZ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/2008|05/23/2008|||APPR|APPROVAL FOR UPDATING THE SECTION OF ADVERSE EVENTS WITH A QUALITATIVE DESCRIPTION OF THE TYPES AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY, AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P990013|S015|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2008|03/21/2008|||OK30|IMPLEMENTATION OF NEW SEMI-AUTOMATED PRODUCTION EQUIPMENT FOR THE BLOCKING PROCESS.
P030016|S003|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|VISIAN IMPLANTABLE COLLAMER LENS|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2008|03/26/2008|||OK30|CHANGES TO THE COLLAMER LENS BLOCKING PROCESS.
P960040|S161|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT TACHY PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2008|03/21/2008|||OK30|ADDITIONAL PRODUCT TO BE PROCESSED ON EXISTING MANUFACTURING EQUIPMENT.
P010012|S173|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN & RENEWAL RF HEART FAILURE PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2008|03/21/2008|||OK30|ADDITIONAL PRODUCT TO BE PROCESSED ON EXISTING MANUFACTURING EQUIPMENT.
P060033|S001|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OVER-THE-WIRE (OTW) & RAPID EXCHANGE (RX) & MULTI EXCHANGE II|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2008|10/02/2008|||APPR|APPROVAL FOR THE SPRINT DELIVERY SYSTEM FAMILY.
P810002|S063|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MASTER HP VALVED GRAFT WITH GELWEAVE VALSALVA|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|09/12/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE PUERTO RICO, CAGUAS, PUERTO RICO.
P970004|S048|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|03/26/2008|||OK30|CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES.
P840001|S106|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY & PRIME FAMILIES OF IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|03/26/2008|||OK30|CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES.
P960009|S046|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|KINETRA NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|03/26/2008|||OK30|CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES.
P030017|S031|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM OR CABLE MODIFICATION|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/2008|06/15/2010|||APPR|APPROVAL FOR THE MODIFICATION OF THE OR CABLE AND INSPECTION TOOL.
P860004|S096|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II IMPLANTABLE INFUSION PUMP||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|03/26/2008|||OK30|CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES.
P030017|S032|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|03/26/2008|||OK30|ADDITION TO THE LINEAR LEADS INSPECTION PROCEDURE.
P030017|S033|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/2008|06/15/2010|||APPR|APPROVAL FOR THE UPDATE TO THE CLINICIAN PROGRAMMER LAPTOP COMPUTER USED WITH THE PRECISION SYSTEM.
P030017|S034|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|03/26/2008|||OK30|ADDITION TO THE LINEAR LEADS INSPECTION PROCEDURE.
P030017|S035|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/2008|06/15/2010|||APPR|APPROVAL FOR THE MODIFICATION OF THE INNER STERILE TRAY COVER.
P960040|S162|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM2/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|03/26/2008|||OK30|ADDING AN ADDITIONAL SUPPLIER OF COMPONENTS.
P010012|S174|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTACT RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|03/26/2008|||OK30|ADDING AN ADDITIONAL SUPPLIER OF COMPONENTS.
P010052|S004|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/2008|12/16/2009|||APPR|APPROVAL FOR IMMULITE/ IMMULITE 1000 ANDIMMULITE 2000 ANTI HBS ASSAY.  THE DEVICE IS INDICATED FOR:IMMULITE/ IMMULITE 1000FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE OR IMMULITE 1000 ANALYZERS FOR THEQUALITATIVE AND QUANTITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN(ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED). ASSAY RESULTS MAY BE USED AS AN AID IN THEDETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITHHBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALSDISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.IMMULITE 2000FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 SYSTEMS AUTOMATED IMMUNOASSAYANALYZERS FOR THE QUALITATIVE AND QUANTITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS BSURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED). ASSAY RESULTS MAY BE USEDAS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING I-IBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIALDIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY ISUNKNOWN.
P000039|S026|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER & MULTI-FENESTRATED SEPTAL OCCLUDER CRIBRIFORM|MAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|07/15/2008|||APPR|ELIMINATION OF A DUPLICATE IN-PROCESS LOAD TEST INSPECTION.
P020024|S020|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|07/15/2008|||APPR|ELIMINATION OF A DUPLICATE IN-PROCESS LOAD TEST INSPECTION.
P040040|S005|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2008|07/15/2008|||APPR|ELIMINATION OF A DUPLICATE IN-PROCESS LOAD TEST INSPECTION.
P980041|S011|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/26/2008|03/26/2008|||APPR|APPROVAL FOR THE ADDITION OF A WARNING REGARDING THE CONCENTRATION OF PROCLIN 300 IN THE ACCESS AFP SAMPLE DILUENT IN THE PRODUCT LABELING.
P970004|S049|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/26/2008|04/24/2008|||APPR|APPROVAL FOR LABELING CHANGES TO THE TECHNICAL MANUAL FOR THE TEST STIMULATION LEAD KIT AND TEST STIMULATION LEAD (MODEL 3065U AND MODEL 3057, RESPECTIVELY) TO EXPLICITLY DESCRIBE THE PRACTICE OF IMPLANTING TWO TEMPORARY TEST STIMULATION LEADS DURING A SINGLE BILATERAL PLACEMENT PROCEDURE FOR SEQUENTIAL TESTING WITHIN THE SEVEN DAY TRIAL PERIOD.
P040027|S011|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2008|03/28/2008|||OK30|DISCONTINUANCE OF THE 100% IN-PROCESS WATER ENTRY PRESSURE TEST FOR THE GRAFT COMPONENT OF THE DEVICE.
P980035|S087|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2008|03/26/2008|||OK30|CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES.
P010015|S038|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2008|03/26/2008|||OK30|CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES.
P000021|S011|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2008|03/13/2008|||OK30|CHANGE TO THE FLEX? ASSEMBLY MACHINE PRODUCTION LINE NUMBER 4 TO ALLOW PRODUCTION OF THE LOCI CHEMISTRIES ON THIS PRODUCTION LINE.
P020027|S007|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2008|03/13/2008|||OK30|CHANGE TO THE FLEX? ASSEMBLY MACHINE PRODUCTION LINE NUMBER 4 TO ALLOW PRODUCTION OF THE LOCI CHEMISTRIES ON THIS PRODUCTION LINE.
P030026|S014|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2008|03/05/2008|||OK30|INTRODUCTION OF A NEW PIECE OF AUTOMATED EQUIPMENT THAT REPLACES A MANUAL ASSEMBLY OPERATION.
P910077|S084|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PACEART INTEGRATION SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2008|03/17/2008|||APPR|APPROVAL FOR THE LATITUDE PACEART INTEGRATION (LPI) (MODEL 6472 V1.0) THAT WILL RESIDE ON THE LATITUDE PATIENT MANAGEMENT SYSTEM (MODEL 6488 V4.0).
P000008|S012|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/28/2008|08/26/2008|||APPR|
P040002|S015|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM|MIH|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/29/2008|03/21/2008|||APPR|APPROVAL FOR TWO NEW LIMB EXTENSION ACCESSORIES, THE TAPERED LIMB EXTENSION AND THE STEPPED LIMB EXTENSION.
P010012|S175|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 AVT CRT-D|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2008|03/17/2008|||APPR|APPROVAL FOR THE SYSTEM SOFTWARE MODEL 2909 V6.02 WITH THE PROGRAMMER MODEL 3120 AND THE MODEL 2893 APPLICATION SOFTWARE FOR THE CONTAK RENEWAL 3 AVT PULSE GENERATORS (MODELS M150, M155, M157 AND M159).
P020018|S026|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/03/2008|07/09/2008|||APPR|APPROVAL FOR USE OF THE NEW Z-TRAK INTRODUCTION SYSTEM WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, TO MODIFY THE ILIAC LEG COMPONENT OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, AND TO CHANGE THE PACKAGING FOR THE MAIN BODY AND ILIAC LEG GRAFTS.
P920015|S039|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2008|04/29/2008|||APPR|APPROVAL FOR A SINGLE-DEFIBRILLATION-COIL VERSION OF THE FDA APPROVED SPRINT QUATTRO MODEL 6947 DUAL-DEFIBRILLATION ?COIL ACTIVE-FIXATION RIGHT VENTRICULAR LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER TE TRADE NAME SPRINT QUATTRO MODEL 6935 LEAD AND IS INTENDED FOR LONG-TERM USE IN THE RIGHT VENTRICLE FOR PATIENTS INDICATED FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P960040|S163|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|FINELINE II/THINLINE II|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2008|04/02/2008|||OK30|ADDITION OF TWO NEW SUPPLIERS FOR MATERIALS.
P030005|S051|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR2|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2008|04/03/2008|||OK30|ADDITIONAL SUPPLIER OF COMPONENTS.
P020027|S008|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT|MTG|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/2008|03/14/2008|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE PRODUCT INSTRUCTIONS FOR USE: 1) ADD A NEW SECTION TITLED RISK AND SAFETY TO PROVIDE ADDITIONAL SAFETY INFORMATION ABOUT THE PRESERVATIVES PRESENT IN SOME OF THE PRODUCT REAGENTS; 2) ADD INFORMATION UNDER THE SECTION TITLED PRECAUTIONS ON THE PRESENCE OF SODIUM AZIDE, ALONG WITH HAZARD AND DISPOSAL INFORMATION; AND 3) PROVIDE FOR REFERENCE ONLY ADDITIONAL UFU CHANGES BEING IMPLEMENTED CONCURRENTLY WITH THE SAFETY INFORMATION.
P000021|S012|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|TPSA FLEX REAGENT|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/2008|03/14/2008|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE PRODUCT INSTRUCTIONS FOR USE: 1) ADD A NEW SECTION TITLED RISK AND SAFETY TO PROVIDE ADDITIONAL SAFETY INFORMATION ABOUT THE PRESERVATIVES PRESENT IN SOME OF THE PRODUCT REAGENTS; 2) ADD INFORMATION UNDER THE SECTION TITLED PRECAUTIONS ON THE PRESENCE OF SODIUM AZIDE, ALONG WITH HAZARD AND DISPOSAL INFORMATION; AND 3) PROVIDE FOR REFERENCE ONLY ADDITIONAL UFU CHANGES BEING IMPLEMENTED CONCURRENTLY WITH THE SAFETY INFORMATION.
P040027|S012|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2008|04/02/2008|||OK30|CHANGE IN THE SUPPLIER OF THE CATHETER COMPONENT.
P030017|S037|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2008|06/15/2010|||APPR|APPROVAL FOR THE IPG AND LEAD EXTENSION CONNECTOR SPRING CONTACT.
P990001|S036|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|IMPLANTABLE PACEMAKER PULSE GENERATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2008|04/02/2008|||OK30|MODIFICATIONS TO THE LASER RIBBON BONDING EQUIPMENT THAT IS USED ON THE DA+ PRODUCTS.
P980016|S123|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO & ENTRUST|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2008|04/03/2008|||OK30|MODIFICATION OF THE INSPECTION CRITERIA FOR THE OPEN ANODE BOTTOM (OAB) AND OPEN CATHODE BOTTOM (OCB) SEPARATOR USED IN THE BATTERY OF MULTIPLE IMPLANTABLE DEVICES.
P010031|S093|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2008|04/03/2008|||OK30|MODIFICATION OF THE INSPECTION CRITERIA FOR THE OPEN ANODE BOTTOM (OAB) AND OPEN CATHODE BOTTOM (OCB) SEPARATOR USED IN THE BATTERY OF MULTIPLE IMPLANTABLE DEVICES.
P980035|S088|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2008|08/04/2008|||APPR|APPROVAL FOR CHANGING THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P010015|S039|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III CRT-P|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2008|08/04/2008|||APPR|APPROVAL FOR CHANGING THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P030017|S039|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2008|04/09/2008|||OK30|ALTERNATE ASSEMBLY METHOD FOR THE CAPACITORS THAT ARE SOLDERED ONTO THE FLEX CONNECTOR.
P020026|S050|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENTS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2008|03/23/2009|||APPR|APPROVAL FOR A CHANGE OF THE TRANSFER OF STENT TRAYS DURING THE SPRAY COATING UNIT OPERATION FROM THE CURRENT METHODOLOGY TO A CONTINUOUS MANNER FROM THE COATING STEP TO ANOTHER.
P980049|S035|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|SMARTVIEW|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2008|03/18/2008|||APPR|APPROVAL FOR THE SMARTVIEW 2.02 UG3 SOFTWARE.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS AND TO ADD THE PACEART XML CONVERTER TO THE SMARTVIEW 2.02 UG2 SOFTWARE.
P900022|S010|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|SMARTVIEW|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2008|03/18/2008|||APPR|APPROVAL FOR THE SMARTVIEW 2.02 UG3 SOFTWARE.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS AND TO ADD THE PACEART XML CONVERTER TO THE SMARTVIEW 2.02 UG2 SOFTWARE.
P950029|S034|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SMARTVIEW|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2008|03/18/2008|||APPR|APPROVAL FOR THE SMARTVIEW 2.02 UG3 SOFTWARE.  THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS AND TO ADD THE PACEART XML CONVERTER TO THE SMARTVIEW 2.02 UG2 SOFTWARE.
P980022|S026|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINIMED REAL-TIME TRANSMITTER (MMT-7703), CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) IPRO DIGITAL RECORDER (MMT-7709)|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2008|04/23/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE MINIMED REAL-TIME TRANSMITTER AND THE CGMS IPRO DIGITAL RECORDER.  THE MODIFICATION INCLUDES ADDING AN ESD PROTECTION DIODE AND A FEW OTHER CIRCUIT CHANGES TO THE RF INPUT/OUTPUT PORT OF THE DEVICES.
P980035|S089|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2008|04/04/2008|||OK30|CHANGE TO THE WORKSTATION USED FOR PERFORMING BUTTON WELDING ON BATTERIES.
P050045|S002|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion|TOP2A FISH PHARMDX|NXG|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2008|03/26/2008|||OK30|CHANGE IN AUXILIARY MATERIAL/SUPPLIER USED IN THE PRODUCTION OF THE PROBE MIX TO ELIMINATE ENZYME RELATED STABILITY PROBLEMS.
P060001|S005|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2008|04/04/2008|||OK30|CHANGE IN VENDORS FOR THE TANTALUM SPHERES.
P840001|S107|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY AND PRIME FAMILIES OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|08/18/2008|||APPR|APPROVAL FOR CHANGING THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P970004|S050|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|08/18/2008|||APPR|APPROVAL FOR CHANGING THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P860004|S097|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|08/18/2008|||APPR|APPROVAL FOR CHANGING THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P960009|S047|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|KINETRA NEUROSTIMULATOR|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|08/18/2008|||APPR|APPROVAL FOR CHANGING THE WORKSTATIONS USED FOR WELDING BATTERY HEADER SUBASSEMBLIES.
P030047|S013|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE PRO RX NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|04/09/2008|||OK30|CHANGE IN A QUALITY CONTROL TEST USED TO DETERMINE SPECIFIC ATTRIBUTES OF THE POLYESTER (PET) SLEEVE.
P950032|S046|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|03/19/2008|||APPR|APPROVAL FOR THE INTRODUCTION OF ADDITIONAL IN-PROCESS BIOBURDEN TESTING AND QUALITY ASSURANCE STEPS TO ENHANCE THE SAFETY PROFILE OF APLIGRAF.
P030054|S083|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE FAMILY OF LEADS-MODELS 1056K, 1056T AND 1058T & QUICKFLEX FAMILY OF LEADS-MODELS 1156T AND 1158T|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/2008|04/23/2008|||APPR|APPROVAL FOR CHANGES TO THE STYLETS, PACKAGING AND LABELING FOR THE QUICKSITE AND QUICKFLEX LEAD FAMILIES.
P000025|S032|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM & MED EL C40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|04/18/2008|||OK30|CHANGE IN MED-EL?S SILICONE SUPPLIER.
P970008|S038|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/2008|09/02/2008|||APPR|APPROVAL FOR THE ADDITION OF THE CTC ADVANCE MICROWAVE CATHETER 2.5-3.5 CM (MODEL NUMBER TV1321C).
P050025|S008|BOSTON SCIENTIFIC|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CAROTID|NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM|NIM|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|04/09/2008|||APPR|APPROVAL FOR THE ESTABLISHMENT OF A NEW TEST TO THE INSPECTION OF INCOMING SUBASSEMBLIES.
P000029|S040|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|04/08/2008|||OK30|MODIFICATION OF METAL ANALYSIS TESTING.
P000029|S041|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|04/08/2008|||OK30|CHANGE IN VENT FILTER FOR THE HOLDING TANKS AND A NEW TEST METHOD FOR INTEGRITY TESTING.
P040024|S019|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|04/02/2008|||OK30|ELIMINATION OF THE METAL ANALYSIS TEST USED TO DETECT IMPURITIES IN NEW STAINLESS STEEL PRODUCTION EQUIPMENT THAT IS USED IN THE MANUFACTURING OF THE DEVICE.
P030017|S040|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|04/11/2008|||OK30|CHANGE IN THE IPG X-RAY INSPECTION PROCESS.
P030017|S041|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|07/24/2008|||APPR|APPROVAL FOR THE INCORPORATION OF A HARDNESS TEST FOR EPOXY.
P050017|S002|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|02/03/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK IRELAND, LTD., LIMERICK, IRELAND FOR MANUFACTURING AND FINAL MANUFACTURING TO INCLUDE LABELING AND PACKAGING, AND FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD., TULLAMORE, IRELAND.
P830061|S040|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE & SP NOVUS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|10/30/2009|||APPR|APPROVAL FOR TRANSFER OF A MANUFACTURING LOCATION FOR A COMPONENT OF THE LEADS.
P950024|S009|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|10/30/2009|||APPR|APPROVAL FOR TRANSFER OF A MANUFACTURING LOCATION FOR A COMPONENT OF THE LEADS.
P930039|S025|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX NOVUS & SUREFIX & CAPSURE FIX|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|10/30/2009|||APPR|APPROVAL FOR TRANSFER OF A MANUFACTURING LOCATION FOR A COMPONENT OF THE LEADS.
P920015|S040|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT FIDELIS & QUATTRO|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|10/30/2009|||APPR|APPROVAL FOR TRANSFER OF A MANUFACTURING LOCATION FOR A COMPONENT OF THE LEADS.
P850089|S057|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS & CAPSURE Z NOVUS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2008|10/30/2009|||APPR|APPROVAL FOR TRANSFER OF A MANUFACTURING LOCATION FOR A COMPONENT OF THE LEADS.
P840001|S108|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRIME FAMILIES OF IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2008|04/10/2008|||OK30|CHANGE IN THE WORKSTATION USED FOR PERFORMING BUTTON WELDING ON BATTERIES.
P860004|S098|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II IMPLANTABLE INFUSION PUMP||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2008|04/10/2008|||OK30|CHANGE IN THE WORKSTATION USED FOR PERFORMING BUTTON WELDING ON BATTERIES.
P970004|S051|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2008|04/10/2008|||OK30|CHANGE IN THE WORKSTATION USED FOR PERFORMING BUTTON WELDING ON BATTERIES.
P000006|S009|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Other Report|N|03/11/2008|05/23/2008|||APPR|APPROVAL FOR A CHANGE OF ACCELERATED AGING TEMPERATURE FROM 65 DEGREES C TO 60 DEGREES C IN A STABILITY PROTOCOL FOR THE DEVICE.
P040044|S005|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2008|05/16/2008|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE MANUFACTURING PROCESSES: 1) REPLACING THE HEATED DIE NECKER MACHINE WITH A HOT AIR NECKER MACHINE; AND 2) REPLACING THE GLASS MOLD BALOON BLOWER MACHINE WITH A METAL MOLD BALLOON BLOWER MACHINE.
P030050|S003|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/11/2008|08/13/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P040021|S006|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR VALVE AND BIOCOR SUPRA VALVE\|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/12/2008|05/06/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P960040|S164|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV ICD|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2008|04/17/2008|||APPR|APPROVAL FOR AN UPDATED HEADER CONFIGURATION FOR THE CONFIENT AND LIVIAN DEVICE FAMILIES TO INCLUDE CHANGED SETSCREWS, SEAL PLUGS, AND LEFT VENTRICULAR RING LEAD WIRE ROUTING (LIVIAN ONLY) AS WELL AS THE ADDITION OF A NEW MODEL TORQUE WRENCH.
P010012|S176|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) MODELS H220, H225, H227, AND H229|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2008|04/17/2008|||APPR|APPROVAL FOR AN UPDATED HEADER CONFIGURATION FOR THE CONFIENT AND LIVIAN DEVICE FAMILIES TO INCLUDE CHANGED SETSCREWS, SEAL PLUGS, AND LEFT VENTRICULAR RING LEAD WIRE ROUTING (LIVIAN ONLY) AS WELL AS THE ADDITION OF A NEW MODEL TORQUE WRENCH.
P020056|S005|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2008|04/11/2008|||OK30|ADDITION OF A QUALITY CONTROL TEST TO BE PERFORMED BY THE SUPPLIER OF THE GEL DISPERSION.
P030017|S042|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2008|08/20/2008|||APPR|APPROVAL FOR MULTIPLE CHANGES TO THE ASSEMBLY METHODS OF THE IPG HEADER.
P030017|S045|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2008|04/11/2008|||OK30|CHANGE TO THE IMPLANTABLE PULSE GENERATOR (IPG) ASSEMBLY PROCEDURE.
P030017|S046|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2008|07/25/2008|||APPR|APPROVAL FOR SUPPLIER REQUIREMENT CHANGES FOR SOME IPG CAPACITORS.
P030017|S047|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2008|04/11/2008|||OK30|CHANGES TO THE FIXTURE USED TO CLAMP DOWN THE CASE HALVES DURING TACK WELDING.
P040024|S020|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2008|04/08/2008|||OK30|CHANGE IN THE FILTER VENT MODEL AND ITS INTEGRITY TEST METHOD USED IN THE MANUFACTURING OF THE DEVICE.
P000029|S042|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2008|04/01/2009|||APPR|APPROVAL FOR UPGRADED PROCESSING EQUIPMENT AND CHANGE IN THE STORAGE TEMPERATURE OF THE RAW MATERIAL.
P980049|S036|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR & DR ICDS|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2008|11/06/2008|||APPR|APPROVAL FOR LASER WELDING ENERGY BEAM MEASUREMENT INTERVALS.
P070009|S002|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2008|04/09/2008|||OK30|CHANGES TO THE MANUFACTURING METHOD AND ASSEMBLY FOR THE REALIZE ADJUSTABLE GASTRIC BAND ANDREALIZE INJECTION PORT.
P050018|S004|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT SCORING BALLOON CATHETER|NWX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2008|04/23/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, INC., LOS ANGELES, CALIFORNIA AS AN ALTERNATE CONTRACT STERILIZATION FACILITY.
P070001|S002|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC C TOTAL DISC REPLACEMENT|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/12/2008|08/11/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P030017|S048|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2008|04/11/2008|||OK30|CHANGE IN THE IPG WELD LASER ENERGY MEASURING EQUIPMENT.
P030017|S049|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2008|08/27/2008|||APPR|APPROVAL FOR CHANGES TO THE IMPLANTABLE PULSE GENERATOR LEAKAGE TEST.
P050020|S001|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2008|04/02/2008|||OK30|CHANGE FOR MINOR MODIFICATIONS TO DEVICE COMPONENTS.
P040044|S006|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/14/2008|03/27/2008|||APPR|APPROVAL FOR MINOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) FOR THE MYNX VASCULAR CLOSURE DEVICE.
P040020|S009|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR ASPHERIC INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2008|04/09/2008|||OK30|ENHANCEMENT OF THE INTRAOCULAR LENS INSPECTION PROCESS.
P810006|S031|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2008|04/15/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF BOVINE DEEP FLEXOR TENDON.
P850010|S028|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2008|04/15/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF BOVINE DEEP FLEXOR TENDON.
P840062|S017|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2008|04/15/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF BOVINE DEEP FLEXOR TENDON.
P900033|S019|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2008|04/15/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF BOVINE DEEP FLEXOR TENDON.
P990020|S031|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2008|04/15/2008|||OK30|MOVING AN INSPECTION PROCESS TO A SUPPLIER.
P000032|S026|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2008|04/16/2008|||OK30|CHANGE IN CONTROL LIMITS FOR PRESSURE TEST.
P950037|S058|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CYLOS DR, PROTOS DR-CLS, PHILOS 2 DR, PHILOS DR, AXIOS DR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2008|04/11/2008|||APPR|APPROVAL FOR AN ALTERNATIVE SOURCE OF THE LITHIUM TO BE USED IN THE DEVICE.
P020056|S006|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/19/2008|08/06/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P030054|S084|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2008|05/02/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE HERCULES 2J ANALOG IO CHIP USED IN THE CURRENT IDC AND PROMOTE CRT-D DEVICES.
P910023|S170|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2008|05/02/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE HERCULES 2J ANALOG IO CHIP USED IN THE CURRENT IDC AND PROMOTE CRT-D DEVICES.
P060002|S002|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT WITH OPTIMIZED DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/20/2008|10/28/2008|||APPR|APPROVAL FOR THE OPTIMIZED DELIVERY SYSTEM, THE TRANSFER OF MANUFACTURING OF THE DELIVERY SYSTEM TO ANGIOMED GMBH & CO., KARLSRUHE, GERMANY, AND THE TRANSFER OF STERILIZATION TO BARD MEDICAL DIVISION REGIONAL STERILIZATION AND REGIONAL STERILIZATION MADISON OPERATION, IN COVINGTON, GEORGIA, AND MADISON, GEORGIA, RESPECTIVELY.
P960013|S038|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|OPTISENSE RIGHT ATRIAL LEAD|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2008|10/01/2009|||APPR|APPROVAL FOR THE OPTISENSE MODEL 1999 RIGHT ATRIAL LEAD.
P060010|S002|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2008|04/25/2008|||OK30|MARKETING OF THE SPANNER TEMPORARY PROSTATIC STENT PRE-LOADED ON THE INSERTION TOOL.
P030016|S004|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENSES|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2008|04/16/2008|||OK30|CHANGE IN THE TUMBLING PROCESS FOR ALL LENSES MANUFACTURED AT THE NIDAU, SWITZERLAND MANUFACTURING FACILITY.
P990013|S016|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2008|04/16/2008|||OK30|IMPLEMENTATION OF A MODIFIED MANUFACTURING PROCESS FOR THE COLLAMER LENSES MANUFACTURED AT THE SWITZERLAND FACILITY.
P840001|S109|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRIME FAMILIES OF IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2008|04/18/2008|||OK30|ADDITION OF A PLASMA CLEANING PROCESS TO DELTA 26H AND RX-1 BATTERY HEADER MANUFACTURING PROCESSES.
P970004|S052|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2008|04/18/2008|||OK30|ADDITION OF A PLASMA CLEANING PROCESS TO DELTA 26H AND RX-1 BATTERY HEADER MANUFACTURING PROCESSES.
P030017|S050|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2008|04/18/2008|||OK30|MODIFICATION TO THE MANUFACTURING HI POT TEST FIXTURE TEST PROCEDURE TO TEST BOTH LINEAR AND ARTISAN LEADS.
P010021|S013|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|03/20/2008|04/16/2008|||APPR|APPROVAL FOR THE MODIFICATION TO INTERFACE THE AUTOMATED VITROS ANALYZER USING THE ROBOTIC INTERFACE MODULE (RIM) TO ENABLE AUTOMATIC TRAY LOADING BETWEEN THE VITROS ANALYZER AND ENGEN SYSTEM.
P910073|S072|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD ADAPTOR MODEL 6952|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/21/2008|07/03/2008|||APPR|APPROVAL FOR A MODIFICATION TO THE SPLIT TUBE WELD FOR ENDOTAK LEAD ADAPTOR MODEL 6952.
P030017|S052|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|08/27/2008|||APPR|APPROVAL FOR A CHANGE TO THE RF TIP ASSEMBLY PROCESS FOR LEAD ASSEMBLIES.
P990001|S037|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA FAMILIES & DIVA FAMILIES & SELECTION AFM & C-SERIES & T- SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P890003|S137|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|THERA-I IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P970012|S034|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR & SR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P010031|S095|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC ICD & INSYNC MARQUIS, INSYNC II & III MARQUIS FAMILY & INSYNC II PROTECT & INSYNC SENTRY & MAXIMO FAMILY||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P980035|S090|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900 FAMILIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P980016|S125|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM DR ICD, GEM II & III FAMILIES, MARQUIS & MAXIMO FAMILES, ONYX, INTRINSIC & ENTRUST & VIRTUOSO FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P980050|S032|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P010015|S041|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC & INSYNC III|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P980035|S091|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2008|04/18/2008|||OK30|ADDITION OF A CLEANING STEP.
P980040|S023|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/2008|05/27/2008|||APPR|APPROVAL FOR REVISIONS TO THE LABELING FOR THE TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00 AS FOLLOWS: 1) MODIFICATIONS TO THE DEVICE DESCRIPTION SECTION TO INCLUDE AN ADDITIONAL DESCRIPTION OF WAVEFRONT-DESIGNED ASPHERIC OPTIC, SQUARED POSTERIOR OPTIC EDGE, FROSTED OPTIC EDGE, AN OPTICAL IMAGE QUALITY GRAPH FOR THE ASPHERIC OPTIC; 2) MODIFICATIONS TO THE ADVERSE EVENTS SAND THE CLINICAL TRIAL SECTIONS TO REFLECT DATA FROM THE ONE-YEAR CLINICAL STUDY RESULTS; AND 3) OTHER ADMINISTRATIVE CHANGES SUCH AS THE REWORDING OF THE LAST SENTENCE ON PAGE 1, ADDING TRADEMARKS TO THE DETAILED DEVICE DESCRIPTION SECTION AND REVISION THE NUMBERING OF THE FIGURES.
P030039|S009|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/23/2008|||OK30|ALTERNATE SUPPLIER.
P030017|S053|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/24/2008|06/15/2010|||APPR|Approval for IPG/ETS Firmware Revision 3.02.
P030017|S054|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|08/21/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE ASSEMBLY PROCEDURE FOR A SURGICAL LEAD.
P030009|S019|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRODRIVER CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|09/25/2008|||APPR|APPROVAL FOR A MOVE IN COMPONENT SUPPLIER LOCATION.
P960058|S061|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR  SYSTEM|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/24/2008|04/21/2008|||APPR|APPROVAL FOR AN UPDATED CHANGE TO THE INSTRUCTIONS FOR USE (IFU) FOR THE ICONNECT, AS ACCESSORY TO THE ADVANCED BIONICS BEHIND-THE-EAR SPEECH PROCESSORS, AS FOLLOWS: FROM: ?THE AURIA ICONNECT CAN ONLY USE A STANDARD SIZE 10 BATTERY.  DO NOT USE ANY OTHER BATTERY.?  TO: ?ONLY ZENIPOWER SIZE 10A BATTERIES FROM ADVANCED BIONICS ARE CERTIFIED FOR USE WITH THE ICONNECT.  PLEASE CONTACT ADVANCED BIONICS OF ITS AUTHORIZED DISTRIBUTORS TO PURCHASE THESE BATTERIES.  OTHER BATTERIES MAY NOT PROVIDE SUFFICIENT BATTERY LIFE WHEN USED WITH THE ICONNECT.?
P790017|S094|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|09/25/2008|||APPR|APPROVAL FOR A MOVE IN COMPONENT SUPPLIER LOCATION.
P060033|S002|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|09/25/2008|||APPR|APPROVAL FOR A MOVE IN COMPONENT SUPPLIER LOCATION.
P000007|S015|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P|DYE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|05/23/2008|||APPR|APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.
P010041|S015|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650|DYE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|05/23/2008|||APPR|APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.
P970008|S039|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/23/2008|||OK30|REMOVAL OF A DUPLICATE QUALITY CONTROL TEST.
P870056|S028|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PORCINE BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PORCIN MITRAL BIOPROSTHESIS|DYE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|05/23/2008|||APPR|APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.
P860057|S045|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS, THEON, RSR, THEON RSR, MAGNA, PLUS MITRAL, THEON MITRAL PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2008|05/23/2008|||APPR|APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.
P870077|S027|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP|DYE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|05/23/2008|||APPR|APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.
P920015|S041|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT & SPRINT QUATTRO & SPRINT QUATTRO SECURE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/18/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
P830061|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, CAPSURE SP, CAPSURE SP NOVUS, CAPSURE SENSE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/18/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
P030036|S005|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/18/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
P010015|S042|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN LV & CS & OTW & ATTAIN BIPOLAR OTW|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/18/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
P930039|S026|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX, CAPSUREFIX NOVUS, SUREFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/18/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
P890003|S138|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD-2|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/18/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
P980016|S126|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/18/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
P850089|S058|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|EXCELLENCE S+, CAPSURE Z, CAPSURE Z NOVUS, CAPSURE SP NOVUS, CAPSURE SP|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2008|04/18/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY.
P030017|S055|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2008|09/05/2008|||APPR|APPROVAL FOR REVISIONS TO STERILIZATION PROCESS INSTRUCTIONS.
P910023|S171|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2008|04/11/2008|||APPR|APPROVAL FOR ENHANCEMENTS TO THE SOFTWARE (VERSION 3.0) USED IN THE ST. JUDE MEDICAL MERLIN.NET SYSTEM.
P030054|S085|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2008|04/29/2008|||APPR|APPROVAL FOR A MINOR SOFTWARE UPDATE TO THE MERLIN PATIENT CARE SYSTEM (VERSION 6.6.1) AND TO THE PROGRAMMER (VERSION 6.6.1).
P030035|S041|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2008|04/29/2008|||APPR|APPROVAL FOR A MINOR SOFTWARE UPDATE TO THE MERLIN PATIENT CARE SYSTEM (VERSION 6.6.1) AND TO THE PROGRAMMER (VERSION 6.6.1).
P880006|S056|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2008|04/29/2008|||APPR|APPROVAL FOR A MINOR SOFTWARE UPDATE TO THE MERLIN PATIENT CARE SYSTEM (VERSION 6.6.1) AND TO THE PROGRAMMER (VERSION 6.6.1).
P910023|S172|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2008|04/29/2008|||APPR|APPROVAL FOR A MINOR SOFTWARE UPDATE TO THE MERLIN PATIENT CARE SYSTEM (VERSION 6.6.1) AND TO THE PROGRAMMER (VERSION 6.6.1).
P970013|S023|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2008|04/29/2008|||APPR|APPROVAL FOR A MINOR SOFTWARE UPDATE TO THE MERLIN PATIENT CARE SYSTEM (VERSION 6.6.1) AND TO THE PROGRAMMER (VERSION 6.6.1).
P880086|S162|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2008|04/29/2008|||APPR|APPROVAL FOR A MINOR SOFTWARE UPDATE TO THE MERLIN PATIENT CARE SYSTEM (VERSION 6.6.1) AND TO THE PROGRAMMER (VERSION 6.6.1).
P990066|S030|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process||N|03/26/2008|05/27/2008|||APPR|APPROVAL FOR THE MODIFICATION OF AUTOMATIC OPTIMIZATION OF PARAMETERS (AOP) SOFTWARE TO INCREASE CONTRAST TO NOISE RATIO FOR THICKER DENSER BREASTS.
P920023|S023|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|AMS UROLUME ENDOPROSTHESIS|MES|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/26/2008|11/23/2011|||APPR|APPROVAL FOR MODIFICATION OF THE DEVICE LABELING TO INCLUDE THE RESULTS OF POST APPROVAL STUDIES.
P840001|S110|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL & RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2008|04/25/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, VILLALBA MANUFACTURING FACILITY.
P040013|S013|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM21S GROWTH FACTOR ENHANCED|NPZ|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/26/2008|08/29/2008|||APPR|APPROVAL FOR: 1) ADDITION OF A CLAIM THAT PDGF STIMULATES ANGIOGENESIS; 2) ADDITION OF A COMPARISON OF PIVOTAL CLINICAL TRIAL RESULTS OBTAINED WITH GEM 21S AND THE RESULTS PUBLISHED ON EMDOGAIN; AND 3) ADDITION OF 36 MONTH LONG TERM EFFICACY DATA TO THE ORIGINAL 6 MONTH STUDY.
P970004|S053|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2008|04/25/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, VILLALBA MANUFACTURING FACILITY.
P960009|S048|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA THERAPY FOR DBS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2008|04/25/2008|||OK30|ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, VILLALBA MANUFACTURING FACILITY.
P050044|S004|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2008|04/25/2008|||OK30|MODIFICATION AND REQUALIFICATION OF AN EXISTING AREA FOR THE MANUFACTURE OF VITAGEL SURGICAL HEMOSTAT.
P030017|S057|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2008|08/19/2008|||APPR|APPROVAL FOR A PACKAGING CHANGE.
P940035|S004|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|NMP22 BLADDERCHEK TEST KIT|NAH|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2008|05/20/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BINAX, INC., SCARBOROUGH, MAINE.
P930021|S011|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|EMDOGAIN|NQA|DE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/2008|06/19/2009|||APPR|APPROVAL FOR THE FOLLOWING:  1) THE USE OF STRAUMANN EMDOGAIN WITH BONE SUBSTITUTE MATERIAL, SUCH AS STRAUMANN BONE CERAMIC; 2) LABELING CHANGES TO MODIFY A STATEMENT REGARDING THE LONG TERM STABILITY OF REGENERATED TISSUE; 3) LABELING CHANGE TO ADD ADDITIONAL SURGICAL TECHNIQUES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS; 4) LABELING CHANGE TO INCLUDE INSTRUCTIONS IN THE ¿STORAGE¿ SECTION IN INSTRUCTIONS FOR USE FOR HOMOGENIZATION IF THE MATERIAL IS SEPARATED IN THE SYRINGE; AND 5) CLARIFY THE INSTRUCTIONS UNDER EACH OF THE THREE CLINICAL PROCEDURES IN THE INSTRUCTIONS FOR USE TO BETTER ALIGN THEM WITH ONE ANOTHER.
P000027|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/2008|10/17/2008|||APPR|APPROVAL FOR EXTENSION OF THE ELECSYS FREE PSA SYSTEM ONTO UPDATED MODEL OF THE MODULAR ANALYTICS E170 ANALYZER, KNOWN AS THE COBAS E 601 ANALYZER.
P990056|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/2008|10/17/2008|||APPR|APPROVAL FOR EXTENSION OF THE ELECSYS TOTAL PSA SYSTEM ONTO UPDATED MODEL OF THE MODULAR ANALYTICS E170 ANALYZER, KNOWN AS THE COBAS E 601 ANALYZER.
P030016|S005|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENSES|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2008|04/24/2008|||OK30|NEW HAPTIC THICKNESS MEASUREMENT MODIFICATION TO THE LATHING PROCESS FOR ALL COLLAMER LENSES MANUFACTURED AT THE NIDAU, SWITZERLAND MANUFACTURING FACILITY.
P990013|S017|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2008|04/24/2008|||OK30|NEW MEASUREMENT MODIFICATION TO THE LATHING PROCESS.
P050007|S009|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2008|08/25/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE INDICATIONS FOR USE.  THE DEVICE, AS MODIFIED, WILL BE INDICATED FOR THE FOLLOWING:  THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.   THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR USE TO ALLOW PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES TO AMBULATE AND BE ELIGIBLE FOR DISCHARGE AS SOON AS POSSIBLE AFTER DEVICE PLACEMENT.  THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.
P790017|S095|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|NC SPRINTER RX BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2008|10/10/2008|||APPR|APPROVAL FOR THE NC SPRINTER RX BALLOON DILATATION CATHETER.
P030009|S020|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|MICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|10/22/2008|||APPR|APPROVAL FOR THE ADDITION OF THE MICRO-DRIVER RAPID EXCHANGE DELIVERY PLATFORMAND THE ADDITION OF THE MEDTRONIC MEXICO FACILITY IN TIJUANA FOR THE MANUFACTURING OF CATHETERSUB-ASSEMBLIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MICRO-DRIVERRAPID EXCHANGE (RX) CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS WITH REFERENCE VESSEL DIAMETERS OF 2.25 - 2.75 MM AND <= 21 MM IN LENGTH. OUTCOME BEYOND 270 DAYS FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
P030017|S059|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|04/30/2008|||OK30|MODIFICATION TO THE IPG ASSEMBLY PROCESS.
P030017|S060|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|04/30/2008|||OK30|IMPLEMENTATION OF IMPROVEMENTS IN THE ARTISAN SURGICAL LEAD ASSEMBLY PROCEDURE.
P030009|S021|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|09/22/2008|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR A SUBASSEMBLY COMPONENT.
P790017|S096|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|SPRINTER LEGEND RX BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2008|10/31/2008|||APPR|APPROVAL FOR THE SPRINTER LEGEND RAPID EXCHANGE BALLOON DILATATION CATHETER.  THE DEVICE, AS MODIFIED, IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE BALLOON DILATATION CATHETER (BALLOON MODELS 2.25 MM ¿ 4.0 MM) IS ALSO INDICATED FOR POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P920015|S042|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SVC TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|04/30/2008|||OK30|MOVING MANUFACTURING LOCATIONS WITHIN THE SAME FACILITY.
P860019|S223|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS|LOX|CV|30-Day Notice||N|03/31/2008|04/28/2008|||OK30|ALTERNATE MANUFACTURING PROCESS FLOW WHICH ALLOWS FOR THE APPLICATION OF SILICONE COATING TO THE BALLOON BEFORE THE BALLOON WING FORM/FOLD PROCESS.
P000029|S043|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|04/28/2008|||OK30|CHANGING TO THE FIRM?S IN-HOUSE ANALYTICAL METHOD DETERMINATIONS FROM THE ANALYTICAL METHODS CURRENTLY PERFORMED BY AN OUTSIDE CONSULTANT LABORATORY.
P040044|S007|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|12/14/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT NUTEK CORPORATION OF CALIFORNIA, HAYWARD, CALIFORNIA, FOR E-BEAM STERILIZATION.
P990020|S032|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|09/11/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM, FOR E-BEAM STERILIZATION.
P030025|S054|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM (OTW)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|04/30/2008|||OK30|CHANGE TO THE SUPPLIER OF THE OTW MANIFOLD COMPONENTS.
P020009|S042|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM (OTW)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|04/30/2008|||OK30|CHANGE TO THE SUPPLIER OF THE OTW MANIFOLD COMPONENTS.
P040016|S029|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM (OTW)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|04/30/2008|||OK30|CHANGE TO THE SUPPLIER OF THE OTW MANIFOLD COMPONENTS.
P860019|S224|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2008|04/30/2008|||OK30|CHANGE TO THE SUPPLIER OF THE OTW MANIFOLD COMPONENTS.
P020026|S051|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENTS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2008|05/01/2008|||OK30|INCLUSION OF THE CORDIS LLC SAN GERMAN SITE AS AN ALTERNATE BACTERIAL ENDOTOXIN TEST (BET) TESTING FACILITY.
P050012|S014|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|SEVEN SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/2008|05/15/2008|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO ALLOW USERS OF THE DEXCOM SEVEN SYSTEM DM2 DATA MANAGER SOFTWARE TO OBTAIN RECEIVER FIRMWARE UPDATES ELECTRONICALLY AND REMOTELY USING THEIR PERSONAL COMPUTER.
P900007|S004|Cook Incorporated|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||CATHETER, SAMPLING, CHORIONIC VILLUS|COOK CHORIONIC VILLUS SAMPLING SET|LLX|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2008|05/08/2008|||OK30|CHANGE IN THE STERILIZATION AGENT USED IN PROCESSING THE COOK CHORIONIC VILLUS SAMPLING SET.
P920015|S043|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT LEADS & SPRINT QUATTRO & SECURE LEAD & SPRINT FIDELIS LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2008|05/01/2008|||OK30|CHANGE TO THE CURE PROCESS AT A COMPONENT SUPPLIER.
P010025|S012|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/2008|05/23/2008|||APPR|APPROVAL FOR A CHANGE TO ALTER THE COMPOSITION OF THE SELENIUM LAYER.
P060038|S001|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2008|07/25/2008|||APPR|APPROVAL FOR: 1) CHANGES TO THE INCOMING INSPECTION CRITERIA FOR THE RAW MATERIAL USED TO MANUFACTURE THE STENT COMPONENT; 2) THE ADDITION OF A NEW SUPPLIER FOR ANALYTICAL RESTING OF THIS RAW MATERIAL; AND 3) CHANGES TO THE VISUAL INSPECTION PROCESS FOR THE STENT COMPONENT.
P980006|S012|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2008|05/30/2008|||APPR|APPROVAL FOR DECREASING THE CENTER THICKNESS OF THE PUREVISION LENS AND ADDING 0.3 WT% HYDROXYPROPYL METHYLCELLULOSE TO THE PACKING SOLUTION.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PUREVISION 2 VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR THE FOLLOWING APPROVED INDICATIONS FOR USE: VISION CORRECTION THE BAUSCH & LOMB PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENS IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS OR LESS, THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +8.00D TO ?20.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO ?20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS.  THE BAUSCH & LOMB PUREVISION 2 MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.  THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) AND PRESBYOPIA IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 2.00 DIOPTERS OR LESS, THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00D TO -18.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO ?20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS WITH ADD POWERS RANGING FROM +0.75D TO +5.00D.. (SEE APPROVAL ORDER FOR ADDITIONAL INFORMATION)
P030017|S061|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2008|05/01/2008|||OK30|CHANGE TO THE VACUUM BAKE PARAMETERS.
P990075|S021|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE -FILLED & SPECTRUM BREAST IMPLANTS|FWM|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/2008|03/31/2009|||APPR|APPROVAL FOR REVISED LABELING THAT REFLECTS 10-YEAR POST-APPROVAL STUDY DATA.
P050020|S002|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2008|05/15/2008|||APPR|APPROVAL FOR: 1) THE ADDITION OF A CARBON COATING TO THE BACK OF THE SENSOR TAIL TO IMPROVE ADHESION OF THE MEMBRANE IN ORDER TO ELIMINATE MICROSCOPIC MEMBRANE FRAGMENTATION; 2) A CHANGE IN THE ORIENTATION OF THE POSITION OF THE SENSOR DURING THE MANUFACTURING PROCESS TO FACILITATE INSPECTION; 3) A LABELING CHANGE, RESULTING FROM THE BACKSIDE CARBON COATING, TO ELIMINATE A CAUTION REGARDING MEMBRANE FRAGMENTS REMAINING IN THE SKIN; 4) AND A CHANGE IN A SUB-SUPPLIER MANUFACTURING SITE, DUPONT, HOPEWELL, VIRGINIA.
P880091|S025|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|SILICONE UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2008|07/29/2008|||APPR|APPROVAL OF MODEL AQ2015A AS A LEVEL A MODIFICATION OF PARENT MODEL AQ2010.
P990013|S018|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER UV-ABSORBING PC INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2008|04/02/2009|||APPR|APPROVAL FOR A CHANGE IN STOPPER MATERIAL FOR THE DEVICE.
P030016|S006|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR VISION IMPLANTABLE COLLAMER LENS|MTA|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2008|04/02/2009|||APPR|APPROVAL FOR A CHANGE IN STOPPER MATERIAL FOR THE COLLAMER LENS.
P970004|S054|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/2008|05/30/2008|||APPR|APPROVAL FOR LABELING CHANGES TO THE PROGRAMMING GUIDE FOR MODELS 8840 NVISION CLINICIAN PROGRAMMER AND 8870 NVISION APPLICATION CARD, TO BETTER DESCRIBE HOW TO DETERMINE THE BATTERY STATUS OF THE MODEL 3058 INTERSTIM IMPLANTABLE NEUROSTIMULATOR AND FOR ADDITIONAL MINOR LABELING CHANGES.
P840001|S111|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY FAMILY OF NEUROSTIMULATOR SYSTEMS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2008|09/12/2008|||APPR|APPROVAL FOR MULTIPLE MANUFACTURING PROCESS CHANGES.
P880090|S023|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|POLYMETHYLMETH-ACRYLATE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2008|05/02/2008|||OK30|CHANGE IN THE LIMULUS AMEBOCYTE LYSATE (LAL) TESTING METHOD AND A CHANGE IN THE SITE FOR THE LAL FINAL PRODUCT TESTING TO BAUSCH & LOMB, INC.?S CLEARWATER, FLORIDA FACILITY.
P840039|S056|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|POLYMETHYLMETH-ACRYLATE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2008|05/02/2008|||OK30|CHANGE IN THE LIMULUS AMEBOCYTE LYSATE (LAL) TESTING METHOD AND A CHANGE IN THE SITE FOR THE LAL FINAL PRODUCT TESTING TO BAUSCH & LOMB, INC.?S CLEARWATER, FLORIDA FACILITY.
P910061|S016|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2008|05/02/2008|||OK30|CHANGE IN THE LIMULUS AMEBOCYTE LYSATE (LAL) TESTING METHOD AND A CHANGE IN THE SITE FOR THE LAL FINAL PRODUCT TESTING TO BAUSCH & LOMB, INC.?S CLEARWATER, FLORIDA FACILITY.
P990014|S005|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|MERIDIAN INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2008|05/02/2008|||OK30|CHANGE IN THE LIMULUS AMEBOCYTE LYSATE (LAL) TESTING METHOD AND A CHANGE IN THE SITE FOR THE LAL FINAL PRODUCT TESTING TO BAUSCH & LOMB, INC.?S CLEARWATER, FLORIDA FACILITY.
N12159|S023|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL ABSORBABLE HEMOSTAT (SURGICEL, SURGICEL NU-KNIT AND SURGICEL FIBRILLAR ABSORBABLE HEMOSTATS)|LMG|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2008|11/26/2008|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT: 1) ETHICON SARL, NEUCHATEL, SWITZERLAND; 2) ETHICON SARL, MARIN SWITZERLAND (WAREHOUSE); AND 3) STUDER AF/WERK HARD, DANIKEN, SWITZERLAND (CONTRACT STERILIZER).
P880090|S024|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2008|06/09/2008|||APPR|APPROVAL TO CHANGE THE LENS CARRIER TO THE ROTARY CAP CARRIER, PN/ 14937-62, FOR THE ANTERIOR CHAMBER IOLS.
P020014|S017|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/04/2008|02/24/2012|||APPR|APPROVAL TO MODIFY THE EXISTING RF ENERGY WARNING TO ADD AN ESSURE/ NOVASURE WARNING.  ADDITIONALLY, THE PMA SUPPLEMENT INCLUDES APPROVAL OF A POST-APPROVAL STUDY.
P000008|S013|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2008|11/25/2008|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A SKIP-LOT TESTING OPTION FOR THE FORCE TO CLOSE TEST.
P050006|S006|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2008|05/07/2008|||OK30|MODIFICATION OF THE FLARING PIN USED IN THE MANDREL FLARING PROCESS AND THE ADDITION OF THE INSPECTION CRITERIA TO THE WIRE INSPECTION PROCEDURE.
P040024|S021|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2008|05/07/2008|||OK30|CHANGE IN STERILITY TESTING LABORATORY USED IN THE MANUFACTURING OF RESTYLANE INJECTABLE GEL.
P010019|S009|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CIBA VISION EXTENDED WEAR SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2008|06/10/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT JOHOR, MALAYSIA FOR FRONT END CONTACT LENS PROCESSING.
P050047|S003|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/07/2008|05/02/2008|||APPR|APPROVAL FOR THE ADDITION OF A NEEDLE TIGHTENING TOOL WITH ASSOCIATED REVISIONS TO THE LABELING AND MODIFICATIONS TO THE PACKAGING.
P840064|S035|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2008|05/05/2008|||OK30|USE OF AN ALTERNATE ANALYTICAL METHOD FOR THE IDENTIFICATION OF RUBBER FORMULATIONS USED IN THE SYRINGE TIP CAP AND STOPPERS.
P890047|S023|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2008|05/05/2008|||OK30|USE OF AN ALTERNATE ANALYTICAL METHOD FOR THE IDENTIFICATION OF RUBBER FORMULATIONS USED IN THE SYRINGE TIP CAP AND STOPPERS.
P990023|S004|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2008|05/05/2008|||OK30|USE OF AN ALTERNATE ANALYTICAL METHOD FOR THE IDENTIFICATION OF RUBBER FORMULATIONS USED IN THE SYRINGE TIP CAP AND STOPPERS.
N17511|S015|COOPERVISION SURGICAL|95 Corporate Dr.||Trumbull|CT|06611||FLUID, HYSTEROSCOPY|HYSKON HYSTEROSCOPY FLUID 32% (W/V) DEXTRAN 70 IN DEXTROSE|LTA|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2008|05/14/2008|||OK30|CHANGE TO THE EQUIPMENT USED FOR CAPPING VIALS.
P000037|S013|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2008|05/12/2008|||OK30|INTRODUCTION OF A SECOND PROOF TEST UNIT.
P010031|S096|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CONSULTA & MAXIMO  ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2008|07/11/2008|||APPR|APPROVAL FOR THE INC. 3 RAMWARE, WHICH CONTAINS A DESIGN CHANGE TO ADDRESS AN ISSUE WITH THE L409 INTEGRATED CIRCUIT (IC) IN THE CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, SECURA DR D224DRG AND SECURA VR D224VRC, MAXIMO II DR D284DRG AND MAXIMO II VR D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P980016|S127|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SECURA & MAXIMO II ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2008|07/11/2008|||APPR|APPROVAL FOR THE INC. 3 RAMWARE, WHICH CONTAINS A DESIGN CHANGE TO ADDRESS AN ISSUE WITH THE L409 INTEGRATED CIRCUIT (IC) IN THE CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, SECURA DR D224DRG AND SECURA VR D224VRC, MAXIMO II DR D284DRG AND MAXIMO II VR D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P910023|S173|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2008|04/30/2008|||APPR|APPROVAL FOR THE MODEL EX2000 V.1.5 VERSION SOFTWARE FOR RUSE ON THE ST. JUDE MEDICAL MERLIN@HOME DM EX1200 DEVICE.
P030054|S086|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2008|04/30/2008|||APPR|APPROVAL FOR THE MODEL EX2000 V.1.5 VERSION SOFTWARE FOR RUSE ON THE ST. JUDE MEDICAL MERLIN@HOME DM EX1200 DEVICE.
P030017|S062|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2008|10/10/2008|||APPR|APPROVAL FOR MODIFYING THE ASSEMBLY AND MANUFACTURING PROCEDURES FOR THE PRECISION CONNECTOR M1.
P010032|S025|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS RC AND EON NEUROSTIMULATION SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2008|01/29/2009|||APPR|APPROVAL FOR A MOBILE, BATTERY POWERED, CHARGING SYSTEM THAT IS DESIGNED TO CHARGE THE GENESISRC NEUROSTIMULATION (IPG) SYSTEM AND THE EON NEUROSTIMULATION (IPG) SYSTEM.
P020031|S003|MICROSULIS MEDICAL LTD.|PARKLANDS BUSINESS PARK||DENMEAD HAMPSHIRE||PO7 6||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA)|MNB|OB|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/2008|09/02/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE FOR THE MEA SYSTEM TO INCLUDE THE RESULTS OF THE LONG-TERM FOLLOW-UP OF STUDY SUBJECTS.
P040002|S017|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM VISIFLEX IS DELIVERY CATHETERS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2008|06/12/2008|||APPR|APPROVAL FOR THE NEW VISIFLEX IS BIFURCATED AND STRAIGHT DELIVERY CATHETERS.
P910077|S086|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ZOOM LATITUDE PROGRAMMING SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2008|05/09/2008|||OK30|ADDITIONAL SUPPLIER FOR A COMPONENT (TOUCH SCREEN) USED IN THE MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM.
P950032|S047|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/19/2008|||OK30|ADDITIONAL SUPPLIER OF A RAW MATERIAL USED TO MANUFACTURE THE APLIGRAF? BI-LAYERED SKIN CONSTRUCT.
P970021|S018|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/12/2008|||OK30|MODIFICATION TO A TEST METHOD.
P920046|S005|FEMCARE LTD.|STUART COURT, SPURSHOLT PLACE, SALISBURY RD|ROMSEY|HAMPSHIRE||SO516||Laparoscopic contraceptive tubal occlusion device|FEMCARE FILSHIE CLIP SYSTEM|KNH|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/15/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WESLEY COE LTD., ENGLAND, UNITED KINGDOM.
P060019|S004|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2008|06/13/2008|||APPR|APPROVAL FOR EXTENSION OF ABLATION TIME FROM 60 TO 120 SECONDS FOR THE COOL PATH CATHETERS, AND MODIFICATIONS TO THE LABELING AND USER INTERFACE TO ACCOMPLISH THIS.
P970021|S019|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2008|05/23/2008|||APPR|APPROVAL FOR A MODIFICATION IN THE ETHYLENE OXIDE STERILIZATION PROCESS TO ACCOMMODATE A MINIMUM LOAD CAPACITY OF ONE PALLET.
P810002|S064|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/16/2008|||OK30|CHANGE IN SUPPLIER THAT FORMS THE SPRING USED ON CERTAIN SJM MECHANICAL HEART VALVE MODELS.
P970021|S020|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE IN THE SUPPLIER?S PROCESSING PARAMETERS FOR A TUBING COMPONENT.
P980035|S092|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|IMPLANTABLE PULSE GENERATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON BATTERIES WHEN MANUFACTURING THE AT500 IPG MODEL AT501.
P980016|S128|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR & MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|MODIFICATIONS TO AN INSPECTION CRITERIA FOR BATTERIES USED IN IMPLANTABLE DEVICES.
P010031|S097|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT & MAXIMO II CRT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|MODIFICATIONS TO AN INSPECTION CRITERIA FOR BATTERIES USED IN IMPLANTABLE DEVICES.
P000032|S027|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2008|05/30/2008|||OK30|CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
P000043|S021|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATRX OFFICE THERMOTHERAPY SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2008|05/30/2008|||OK30|CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
P000053|S015|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2008|05/30/2008|||OK30|CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
P010020|S009|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2008|05/30/2008|||OK30|CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
P920023|S024|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME URETHRAL STENT|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2008|05/30/2008|||OK30|CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
P950024|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI EPICARDIAL STEROID ELUTING PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P980016|S129|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P980050|S033|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CS-SVC TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P010031|S098|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||ATTAIN SD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P030036|S006|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P010015|S043|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN CS & ATTAIN OTW & ATTAIN BIPOLAR OTW|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P900061|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P920015|S044|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P890003|S139|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2008|05/14/2008|||OK30|CHANGE TO THE RICE CREEK FACILITY?S ETHYLENE OXIDE (ETO) STERILIZATION EXPOSURE TIME FOR LEADS, PACING ACCESSORIES, AND ADAPTOR PRODUCTS.
P910023|S174|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2008|05/15/2008|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR THE HIGH-VOLTAGE HYBRID ASSEMBLY.
P030054|S087|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2008|05/15/2008|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR THE HIGH-VOLTAGE HYBRID ASSEMBLY.
P950018|S010|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2008|06/04/2008|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ALCON RESEARCH, LTD., FORT WORTH, TEXAS.
P880091|S026|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL SILICONE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2008|05/14/2008|||OK30|CHANGE TO A NEW SAMPLE HOLDING FIXTURE FOR THE IN-PROCESS HAPTIC PULL TEST PERFORMED ON THE 3-PIECE SILICONE LENSES.
P960043|S063|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEMS|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/16/2008|06/12/2008|||APPR|APPROVAL FOR CHANGING FROM THE SURGIPRO II SUTURE TO THE MODIFIED SURGIPRO II SUTURE.
P960009|S049|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/14/2008|04/16/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060033|S003|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2008|05/16/2008|||OK30|REUSE OF CATHETER HOOPS FOR THE ENDEAVOR OVER-THE-WIRE (OTW), MULTI-EXCHANGE II (MX2), AND RAPID EXCHANGE (RX) CORONARY STENT SYSTEMS.
P040048|S004|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2008|07/25/2008|||APPR|APPROVAL FOR A CHANGE IN THE LATHE AND MILLING TOOL.
P960040|S165|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM II & VITALITY FAMILIES OF ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2008|05/19/2008|||OK30|ADD A SECOND SUPPLIER FOR A COMPONENT IN THE HYBRID CIRCUIT.
P010012|S177|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2008|05/19/2008|||OK30|ADD A SECOND SUPPLIER FOR A COMPONENT IN THE HYBRID CIRCUIT.
P040020|S010|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR  IQ IOL|MFK|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/2008|06/20/2008|||APPR|APPROVAL FOR CHANGING THE TRADE NAME OF THE DEVICE FROM ACRYSOF RESTOR ASPHERIC APODIZED DIFFRACTIVE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) TO ACRYSOF IQ RESTOR APODIZED DIFFRACTIVE POSTERIOR CHAMBER IOL.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTOR APODIZED DIFFRACTIVE POSTERIOR CHAMBER IOL, MODEL SN6AD3, AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE.
P040048|S005|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2008|05/16/2008|||OK30|CHANGE IN THE GAMMA STERILIZATION DOSE VERIFICATION METHOD FOR THE TRILOGY AB ACETABULAR SYSTEM.
P070009|S003|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/2008|10/15/2008|||APPR|APPROVAL FOR A LINE EXTENSION TO THE REALIZE ADJUSTABLE GASTRIC BANDTHE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REALIZE ADJUSTABLE GASTRICBAND CURVED (MODEL BD3XV) AND IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTSAND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OFAT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS. THE BAND IS INDICATED FOR USE ONLY INMORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES,SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.
P050020|S003|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR|MDS|CH|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/21/2008|05/21/2008|||APPR|APPROVAL FOR TWO LABELING MODIFICATIONS: 1) TO MODIFY A WARNING REGARDING USE OF THE SYSTEM IN AN ENVIRONMENT WHERE ANESTHETIC GAS IS USED TO INSTEAD WARN AGAINST USE IN ENVIRONMENTS THAT CONTAIN ANY COMBUSTIBLE GAS; AND 2) TO ADD LANGUAGE TO THE INSTRUCTIONS FOR MUTING ALARMS TO CLARIFY WHEN IT IS NOT RECOMMENDED TO DO SO AND ALSO TO CLARIFY WHEN THE SYSTEM WILL GO INTO ABANDON ALARM MODE WHEN THE ALARMS ARE MUTED.
P030025|S055|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2008|05/21/2008|||OK30|CHANGE TO A TEST METHOD AND CORRESPONDING SPECIFICATIONS FOR THE TENSILE PROPERTY OF THE BALLOON TUBE COMPONENT.
P870072|S040|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2008|10/31/2008|||APPR|APPROVAL TO STRENGTHEN THE IVAD Y-CONNECTOR TERMINATION BY ADDING A SMALL AMOUNT (35 UL) OF SILICONE OIL TO THE INNER WALL OF THE PNEUMATIC LINE TO REDUCE THE TRANSFERABLE FORCE BETWEEN THE IVAD OPTICAL SENSOR CABLE AND THE PNEUMATIC LINE WALL.
P040016|S030|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2008|05/21/2008|||OK30|CHANGE TO A TEST METHOD AND CORRESPONDING SPECIFICATIONS FOR THE TENSILE PROPERTY OF THE BALLOON TUBE COMPONENT.
P930014|S024|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSERT DELIVERY SYSTEM|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2008|02/05/2009|||APPR|APPROVAL OF THE ACRYSERT DELIVERY SYSTEM WITH THE ACRYSOF IQ IOL MODEL SN60WS.
P060033|S004|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2008|05/13/2008|||OK30|ELIMINATION OF THE ?FINAL INSPECTION PRE-CLEAN? WORK STEP (PRE-PC SPRAY INSPECTION) OF THE PHOSPHORYLCHOLINE (PC) POLYMER BASECOAT SPRAY PROCESS FOR THE ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM.
P030009|S022|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRODRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2008|05/21/2008|||OK30|CHANGE IN THE WELDING PROCESS.
P060033|S005|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2008|05/21/2008|||OK30|CHANGE IN THE WELDING PROCESS.
P960040|S166|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE TACHY PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2008|05/21/2008|||OK30|PROCESSING OF ADDITIONAL PRODUCT ON EXISTING BONDER MACHINES.
P010012|S178|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL HEART FAILURE PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2008|05/21/2008|||OK30|PROCESSING OF ADDITIONAL PRODUCT ON EXISTING BONDER MACHINES.
P020009|S043|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2008|05/21/2008|||OK30|CHANGE TO A TEST METHOD AND CORRESPONDING SPECIFICATIONS FOR THE TENSILE PROPERTY OF THE BALLOON TUBE COMPONENT.
P880047|S012|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2008|11/26/2008|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT: 1) ETHICON SARL, NEUCHATEL, SWITZERLAND; 2) ETHICON SARL, MARIN SWITZERLAND (WAREHOUSE); AND 3) STUDER AF/WERK HARD, DANIKEN, SWITZERLAND (CONTRACT STERILIZER).
P980003|S021|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION CATHETER|LPB|CV|Normal 180 Day Track|Labeling Change - PAS|N|04/23/2008|09/19/2008|||APPR|APPROVAL FOR LABELING CHANGES RESULTING FROM COMPLETION OF THE CONDITION OF APPROVAL STUDY.
P990048|S003|CARL ZEISS MEDITEC AG|5160 Hacienda Drive||Dublin|CA|94568||SYSTEM, LASER, PHOTODYNAMIC THERAPY|VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER|MVF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2008|10/31/2008|||APPR|APPROVAL FOR CHANGES TO THE LASER CONTROLLER; THE ADDITION OF NEW USER INTERFACE INCLUDING TOUCH-SENSITIEVE SCREEN AND ROTARY KNOBS; A NEW INTEGRATED POWER SUPPLY WITH MICRO-CONTROLLER ELECTRONIC COMPONENTS; NEW LABELING; AND NEW SOFTWARE (FIRMWARE).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULAS 690PLUS AND VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE IN VISUDYNE THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE (VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO MACULAR DEGENERATION, PRESUMED OCULAR HISTOPLASMOSIS OR PATHOLOGIC MYOPIA.
P040002|S018|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM, 25MM, 28MM, AND 34MM SUPRARENAL BIFURCATED STENT GRAFTS AND ACCESSORIES|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2008|10/08/2008|||APPR|APPROVAL FOR SUPRARENAL VERSIONS OF THE POWERLINK BIFURCATED STENT GRAFTS AND ACCESSORIES.
P970004|S055|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2008|05/22/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P840001|S112|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IPG/IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2008|05/22/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P830061|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE & VITATRON|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2008|06/11/2008|||APPR|APPROVAL FOR A FACILITY TRANSFER FOR A COMPONENT MANUFACTURER.
P930039|S027|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS & VITATRON|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2008|06/11/2008|||APPR|APPROVAL FOR A FACILITY TRANSFER FOR A COMPONENT MANUFACTURER.
P960009|S050|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|KINETRA & SOLETRA FAMILY OF NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2008|05/22/2008|||OK30|MODIFICATIONS TO THE STERILIZATION PROCESS.
P960013|S039|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL MODEL 1882TC LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2008|05/16/2008|||OK30|ALTERNATE MANUFACTURING TOOL.
P960009|S051|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/2008|03/27/2009|||APPR|APPROVAL FOR THE FOLLOWING NEW COMPONENTS AND ACCESSORIES FOR THE ACTIVA RCRECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM:¿ ACTIVA RC, MODEL 37612 (NEUROSTIMULATOR)¿ PATIENT PROGRAMMER, MODEL 37642¿ MODEL 8870 APPLICATION CARD (ACTIVA RC)¿ EXTERNAL NEUROSTIMULATOR, MODEL 37022¿ 8-4 EXTENSION, MODEL 37085¿ ALLIGATOR CLIP SCREENING CABLE. MODEL 3550-67¿ TWIST LOCK SCREENING CABLE, MODEL 3550-68THE ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM IS INDICATED AS FOLLOWS:MEDTRONIC ACTIVA THERAPY INCLUDES ACTIVA PARKINSON'S CONTROL THERAPY AND ACTIVA TREMORCONTROL THERAPY.PARKINSON'S CONTROL THERAPYBILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN)USING MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPA-RESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.TREMOR CONTROL THERAPY UNILATERAL THALAMIC STIMULATION BY THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM IS INDICATEDFOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY. THE SYSTEM IS INTENDED FOR USE INPATIENTS WHO ARE DIAGNOSED WITH ESSENTIAL TREMOR OR PARKINSONIAN TREMOR NOT ADEQUATELYCONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.
P030016|S007|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR VISIAN IMPLANTABLE COLLAMER LENS|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2008|05/23/2008|||OK30|CHANGE TO IMPLEMENT A NEW STERILIZATION PROCESS.
P990013|S019|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2008|05/30/2008|||OK30|REPLACING THE OLD SELF-CONTAINED IRRADIATOR WITH A NEW UNIT OF THE SAME MODEL.
P000029|S044|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2008|05/23/2008|||OK30|ADDITIONAL STERILITY TESTING LABORATORY.
P000006|S010|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/25/2008|08/22/2008|||APPR|
P000025|S033|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|SONATA TI 100 COCHLEAR IMPLANT|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2008|06/20/2008|||APPR|APPROVAL FOR THE USE OF AN ALTERNATIVE HYBRID COMPONENT IN THE MANUFACTURE OF THE SONATATI100 COCHLEAR IMPLANT CALLED THE ¿SONATA HYBRID 2¿. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SONATATI100 COCHLEAR IMPLANT AND IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: ADULTS EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE BILATERAL, SENSORINEURAL HEARING IMPAIRMENT AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS. THESE INDIVIDUALS TYPICALLY DEMONSTRATE BILATERAL SEVERE TO PROFOUND SENSORINEURAL HEARING LOSS DETERMINED BY A PURE TONE AVERAGE OF 70 DB OR GREATER AT 500 HZ, 1000 HZ, AND 2000 HZ. LIMITED BENEFIT FROM AMPLIFICATION IS DEFINED BY TEST SCORES OF 40% CORRECT OR LESS IN BEST-AIDED LISTENING CONDITION ON CD RECORDED TESTS OF OPEN-SET SENTENCE RECOGNITION (HEARING IN NOISE TEST [HINT] SENTENCES).  CHILDREN AGED TWELVE (12) MONTHS TO SEVENTEEN (17) YEARS ELEVEN (11) MONTHS MUST DEMONSTRATE A PROFOUND, BILATERAL SENSORINEURAL HEARING LOSS WITH THRESHOLDS OF 90 DB OR GREATER AT 1000 HZ. IN YOUNGER CHILDREN, LITTLE OR NO BENEFIT IS DEFINED BY LACK OF PROGRESS IN THE DEVELOPMENT OF SIMPLE AUDITORY SKILLS IN CONJUNCTION WITH APPROPRIATE AMPLIFICATION AND PARTICIPATION IN INTENSIVE AURAL HABILITATION OVER A THREE (3) TO SIX (6) MONTH PERIOD. IN OLDER CHILDREN, LACK OF AID BENEFIT IS DEFINED AS < 20% CORRECT ON THE MULTI-SYLLABIC LEXICAL NEIGHBOURHOOD TEST (MLNT) OR LEXICAL NEIGHBOURHOOD TEST (LNT), DEPENDING UPON THE CHILD'S COGNITIVE ABILITY AND LINGUISTIC SKILLS. A THREE (3) TO SIX (6) MONTH HEARING AID TRIAL IS REQUIRED FOR CHILDREN WITHOUT PREVIOUS EXPERIENCE WITH HEARING AIDS. RADIOLOGICAL EVIDENCE OF COCHLEAR OSSIFICATION MAY JUSTIFY A SHORTER TRIAL WITH AMPLIFICATION.
P060033|S006|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2008|05/27/2008|||OK30|ALTERNATE INNER POUCH SEALING PROCESS.
P900056|S091|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2008|05/30/2008|||OK30|CHANGES TO THE MANUFACTURING TOLERANCE SPECIFICATIONS OF THE WELD LOCATIONS.
P020004|S034|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2008|09/24/2008|||APPR|APPROVAL FO NO LONGER MONITOR A DEVICE MANUFACTURING SPECIFICATION.
P960040|S167|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN FAMILY OF ICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/30/2008|05/08/2008|||APPR|APPROVAL FOR UPDATES TO THE PROGRAMMER SW MODEL 2868 V1.02 AND PULSE GENERATOR FIRMWARE V1.04.0, PATCH V1.00 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES.
P050020|S004|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/2008|10/08/2008|||APPR|APPROVAL FOR THE COPILOT HEALTH MANAGEMENT SYSTEM TO BE USED IN AN ACCESSORY DATA MANAGEMENT SYSTEM WITH THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM.
P010025|S013|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA DIMENSIONS (2D) FFDM SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/2008|12/22/2008|||APPR|APPROVAL FOR THE SELENIA DIMENSIONS (2D) FFDM SYSTEM.
P010012|S179|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CARDIAC RESYNCHRONIZATION HIGH ENERGY DEFIBRILLATOR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/30/2008|05/08/2008|||APPR|APPROVAL FOR UPDATES TO THE PROGRAMMER SW MODEL 2868 V1.02 AND PULSE GENERATOR FIRMWARE V1.04.0, PATCH V1.00 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES.
P990012|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/2008|10/30/2008|||APPR|APPROVAL TO EXTEND APPLICATION OF THE ELECSYS HBSAG AND ELECSYS ANTI-HBS TEST SYSTEMS ONTO THE UPDATED VERSION OF THE MODULAR ANALYTICS E170 ANALYZER KNOWN AS THE COBAS E 601 ANALYZER.  WHILE THE MODULAR ANALYTICS MODULAR SYSTEM INTEGRATES THE E170 MODULE WITH CLINICAL CHEMISTRY MODULES P OR D, THE COBAS E 601 IMMUNOASSAY ANALYZER IS A COMPONENT OF THE C6000 MODULAR SYSTEM WHICH INTEGRATES IMMUNOLOGY TESTING WITH THE COBAS C 501 CLINICAL CHEMISTRY ANALYSER.  THERE HAVE BEEN NO CHANGES TO THE COMPOSITION OF ANY OF TE TEST SYSTEM REAGENTS (IMMUNOASSAY, CONTROLS OR CONFIRMATORY TEST), THE APPLICATION PARAMETERS, THE ANALYZER¿S ANALYTICAL MEASURING COMPONENT OR HOW THE RESULTS ARE CALCULATED.  THE INDICATIONS FOR USE OF THE TWO TEST SYSTEMS REMAIN THE SAME.
P010054|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/2008|10/30/2008|||APPR|APPROVAL TO EXTEND APPLICATION OF THE ELECSYS HBSAG AND ELECSYS ANTI-HBS TEST SYSTEMS ONTO THE UPDATED VERSION OF THE MODULAR ANALYTICS E170 ANALYZER KNOWN AS THE COBAS E 601 ANALYZER.  WHILE THE MODULAR ANALYTICS MODULAR SYSTEM INTEGRATES THE E170 MODULE WITH CLINICAL CHEMISTRY MODULES P OR D, THE COBAS E 601 IMMUNOASSAY ANALYZER IS A COMPONENT OF THE C6000 MODULAR SYSTEM WHICH INTEGRATES IMMUNOLOGY TESTING WITH THE COBAS C 501 CLINICAL CHEMISTRY ANALYSER.  THERE HAVE BEEN NO CHANGES TO THE COMPOSITION OF ANY OF TE TEST SYSTEM REAGENTS (IMMUNOASSAY, CONTROLS OR CONFIRMATORY TEST), THE APPLICATION PARAMETERS, THE ANALYZER¿S ANALYTICAL MEASURING COMPONENT OR HOW THE RESULTS ARE CALCULATED.  THE INDICATIONS FOR USE OF THE TWO TEST SYSTEMS REMAIN THE SAME.
P020012|S003|SUNEVA MEDICAL, INC.|5879 PACIFIC CENTER BLVD.||SAN DIEGO|CA|92121||Implant, dermal, for aesthetic use|ARTEFILL|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/28/2008|08/13/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P030009|S023|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2008|09/11/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM, FOR E-BEAM STERILIZATION.
P790017|S097|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|NC STORMER BALLOON DILATATION CATHETERS|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2008|09/11/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM, FOR E-BEAM STERILIZATION.
P910073|S073|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE FAMILY OF LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2008|10/31/2008|||APPR|APPROVAL FOR ADDITIONAL INSPECTION STEPS.
P900060|S040|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2008|05/27/2008|||OK30|USE OF AN ADDITIONAL STEAM STERILIZATION CHAMBER.
P010029|S007|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA 1% SODIUM HYALURONATE|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2008|07/01/2009|||APPR|APPROVAL FOR THE STERILE SODIUM HYALURONATE (NAHA) TO BE STORED IN STERILE, DISPOSABLE POLYETHYLENE BAGS FOR UP TO 48 HOURS PRIOR TO FILLING THE SYRINGES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EUFLEXXA AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P030053|S006|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/29/2008|08/24/2009|||APPR|APPROVAL FOR LABELING CHANGES AFTER FOCUS GROUP INPUT.
P950020|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW)|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2008|05/27/2008|||OK30|CHANGE IN SUPPLIER FOR THE BALLOON TUBING EXTRUSION PROCESS.
P990013|S020|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2008|06/04/2008|||OK30|CHANGE TO IMPLEMENT A NEW HAAS OFFICE MILLING MACHINE AT THE MONROVIA, CALIFORNIA MANUFACTURING FACILITY USED FOR MILLING COLLAMER INTRAOCULAR LENSES.
P060033|S007|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/05/2008|07/03/2008|||APPR|APPROVAL FOR A SHELF LIFE EXTENSION FOR THE PRODUCT, FROM 12 MONTHS TO 18 MONTHS.
P860019|S225|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|BOSTON SCIENTIFIC QUANTUM MAVERICK PTCA DILATATION CATHETERS|LOX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/06/2008|07/03/2008|||APPR|APPROVAL FOR MINOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE FOR THE QUANTUM MAVERICK PTCA CATHETERS.
P040044|S008|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2008|07/22/2008|||APPR|APPROVAL FOR CHANGING THE METHOD OF ATTACHMENT OF THE TENSION PLUNGER TO THE COREWIRE OF THE MYNX VASCULAR CLOSURE DEVICE TO OVERMOLD THE TENSION PLUNGER DIRECTLY ONTO THE COREWIRE.
P980007|S009|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|MIGRATION OF THE ABBOTT ARCHITECT FREE PSA ASSAY TO THE NEW ARCHITECT I1000 SYSTEM|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/2008|05/28/2009|||APPR|APPROVAL FOR MIGRATION OF THE ARCHITECT FREE PSA ASSAY TO A NEWARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR.
P910007|S017|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA ASSAY|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/2008|05/29/2009|||APPR|APPROVAL FOR MIGRATION OF THE ARCHITECT TOTAL PSA ASSAY TO A NEWARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR.
P020004|S035|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/02/2008|11/05/2008|||APPR|APPROVAL FOR THE DISTRIBUTION OF THE 2008 ANNUAL CLINICAL UPDATE TO PHYSICIAN USERS FOR THE GORE EXCLUDER AAA ENDOPROSTHESIS.
P050020|S005|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2008|06/02/2008|||OK30|CHANGE FOR MINOR MODIFICATIONS TO THE DEVICE COMPONENTS.
P950022|S052|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|DURATA, RIATA ST OPTIM, RIATA ST, RIATA 8F|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2008|09/18/2008|||APPR|APPROVAL FOR A LABELING CHANGE TO ADD A PRECAUTION AGAINST USE OF DURATA LEADS WITH THE ST. JUDE MEDICAL SEAL AWAY VALVE.
P050043|S001|MORRIS INNOVATIVE RESEARCH INC|907 W.SECOND ST||BLOOMINGTON|IN|47403||Device, hemostasis, vascular|FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2008|07/02/2008|||APPR|APPROVAL FOR MODIFICATION OF THE SHEATH.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FISH-SP AND IS INDICATED FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES.  THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5,6, AND 8 FRENCH PROCEDURAL SHEATHS.
P060033|S008|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2008|06/06/2008|||OK30|USE OF A 50MM STENT STORAGE AND TRANSPORTATION VIAL WITHIN THE ENDEAVOR STENT MANUFACTURING PROCESS.
P020004|S036|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2008|06/05/2008|||OK30|AUTOMATING A MANUAL SEWING PROCESS.
P000007|S016|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2008|05/22/2008|||OK30|CHANGE IN SUPPLIERS FOR A POLYESTER RAW MATERIAL USED IN THE MANUFACTURE OF THE DEVICE.
P930038|S055|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2008|05/29/2008|||OK30|ALTERNATE ABATTOIR TO SUPPLY BOVINE HIDES FOR COLLAGEN USED IN THE MANUFACTURE OF THE DEVICE.
P910023|S175|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/09/2008|06/24/2008|||APPR|APPROVAL FOR MINOR MODIFICATIONS AND STANDARDIZATION OF THE GROUND CONNECTION, OUTPUT FLEX, HEAT SHIELD, AND BATTERY SUPPORT FOR ATLA, ATLAS II, CONVERT, CURRENT, EPIC, EPIC II, AND PROMOTE CRT-D AND ICD FAMILIES.
P030054|S088|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY CRT-DS|NIK|CV|Real-Time Process||N|05/09/2008|06/24/2008|||APPR|APPROVAL FOR MINOR MODIFICATIONS AND STANDARDIZATION OF THE GROUND CONNECTION, OUTPUT FLEX, HEAT SHIELD, AND BATTERY SUPPORT FOR ATLA, ATLAS II, CONVERT, CURRENT, EPIC, EPIC II, AND PROMOTE CRT-D AND ICD FAMILIES.
P020018|S027|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2008|06/04/2008|||APPR|APPROVAL FOR THE ADDITION OF A QUALITY CONTROL STEP VERIFYING THE ORIENTATION OF THE CONVERTER WHILE IT IS BEING LOADED INTO THE DELIVERY CATHETER.
P000025|S034|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2008|06/13/2008|||OK30|MOVEMENT OF AN EXISTING PROCESS STEP TO A LATER STAGE OF THE MANUFACTURING PROCESS.
P970004|S056|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY: TORQUE WRENCH AND BOOK KIT, MODEL 3550-80|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2008|07/03/2008|||APPR|APPROVAL FOR THE ADDITION OF CONVENIENCE KIT (MODEL 3550-80) WHICH INCLUDES A TORQUE WRENCH AND BOOT CONNECTOR.
P900056|S092|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/2008|06/10/2008|||APPR|APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE (DRU) FOR THE ROTALINK EXCHANGEABLE CATHETER.
P050038|S005|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/09/2008|06/23/2008|||APPR|APPROVAL FOR THE ADDITION OF A NEW TRADE NAME.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEMOSTASE MPH AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL AND OPHTHALMIC) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIAL BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES ARE INEFFECTIVE OR IMPRACTICAL.
P050006|S007|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2008|06/11/2008|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE UPPER AND LOWER TEMPERATURE BONDING SET POINT AND REJECT LIMITS OF THE HELEX LEAFLET BONDING PROCESS.
P040014|S007|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2008|06/09/2008|||OK30|ADDITIONAL SUPPLIERS FOR THE DEVICE.
P040042|S012|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8, THERAPY & SAFIRE TX ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2008|06/09/2008|||OK30|ADDITIONAL SUPPLIERS FOR THE DEVICE.
P050023|S011|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KRONOS LV-T CRT-D|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/2008|11/04/2008|||APPR|APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DS AND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES
P820076|S024|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|STRATOS LV & STRATOS LV-T-CRT-P'S|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2008|06/02/2008|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.
P950037|S059|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ACTROS, AXIOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, AND PROTOS FAMILIES OF PULSE GENERATORS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/2008|11/04/2008|||APPR|APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DSAND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES
P980023|S031|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|CARDIAC AIRBAG AND BELOS FAMILIES OF ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/2008|11/04/2008|||APPR|APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DSAND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES
P000009|S026|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMOS ICDS/XELOS DR-T ICD/LEXOS ICDS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/2008|11/04/2008|||APPR|APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DSAND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES
P950037|S060|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2008|06/02/2008|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.
P980023|S032|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2008|06/02/2008|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.
P000009|S027|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PHYLAX AV ICD SYSTEM|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2008|06/02/2008|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.
P050023|S012|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KRONOS LV-T CRT-D|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2008|06/02/2008|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.
P070027|S001|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/2008|07/15/2008|||APPR|APPROVAL FOR USE OF THE NEW XCELERANT HYDRO DELIVERY SYSTEM WITH THE TALENT ABDOMINAL STENT GRAFT.
P030002|S015|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|NAA|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2008|06/13/2008|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BAUSCH & LOMB, INC., RANCHO CUCAMONGA, CALIFORNIA.
P070027|S002|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/15/2008|11/05/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000044|S018|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR, HBSAG CONFIRMATORY ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2008|06/12/2008|||OK30|ADDITION OF A NEWS SUPPLIER FOR HUMAN DEFIBRINATED ANTI-HBS NEGATIVE PLASMA AND UPDATING OF THE RAW MATERIAL DOCUMENTATION.
P940035|S005|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|NMP22 ELISA TEST KIT|NAH|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2008|06/03/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BINAX, INC., SCARBOROUGH, MAINE.
P060001|S006|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/16/2008|10/08/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P840001|S113|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2008|06/10/2008|||OK30|ADD A NEW COMPONENT VENDOR TO SUPPLY TWO INTEGRATED CIRCUITS (ICS) FOR USE ON THE HYBRIDS IN THE RESTORE FAMILY OF DEVICES.
P980022|S027|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN REAL-TIME MONITOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2008|06/16/2008|||OK30|CHANGES TO THE MONITOR VIBRATOR MOTOR INCLUDING CONFORMANCE WITH ROHS DIRECTIVE WHICH RESTRICTS THE USE OF HAZARDOUS MATERIALS IN THE MANUFACTURE OF ELECTRICAL AND ELECTRONIC PRODUCTS.
P050016|S003|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2008|07/07/2008|||APPR|APPROVAL FOR A NEW HEAD FINISHING REAMER, THE ADDITION OF A STRAIGHT HANDLED MECHANICAL CUP INTRODUCER AND A REVISED CORMET OPERATIVE TECHNIQUE.  THE DEVICE IS INDICATED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD AND CEMENTLESS ACETABULAR COMPONENT.  THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING CONDITIONS: 1) NON-INFLAMMATORY DEGENERATIVE ARTHRITIS SUCH AS OSTEOARTHRITIS AND AVASCULAR NECROSIS; AND 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.  THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING IPSILATERAL HIP JOINT REVISION.
P070008|S001|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/2008|11/04/2008|||APPR|APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DSAND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES
P070008|S002|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/15/2008|06/02/2008|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.
P040024|S022|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2008|05/30/2008|||APPR|APPROVAL FOR THE INTRODUCTION OF A QC SAMPLE TO THE TEST METHOD FOR PROTEIN CONTENT IN HA RAW MATERIAL.
P950020|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CORONARY FLEXTOME CUTTING BALLOON|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2008|06/06/2008|||OK30|CHANGE TO THE IN-PROCESS BALLOON INFLATION PRESSURE FOR MODELS OF THE FLEXTOME CUTTING BALLOON.
P050044|S005|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2008|05/30/2008|||APPR|APPROVAL TO CHANGE THE VENDOR OF THE 1 LITER AND 5 LITER MEDIA BAGS USED TO STORE INTERMEDIAE SOLUTIONS DURING VITAGEL ASEPTIC PROCESSING.
P010038|S015|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECONDLOOK (SL) CAD|MYN|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2008|10/09/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ICAD, INC., NASHUA, NEW HAMPSHIRE.
P980022|S028|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CGMS IPRO SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2008|07/17/2008|||APPR|APPROVAL FOR THE MMT-7319 SOLUTIONS SOFTWARE FOR CGMS IPRO CONTINUOUS GLUCOSE RECORDER TO DOWNLOAD BLOOD GLUCOSE METER VALUES, OR MANUAL ENTRY OF BLOOD GLUCOSE VALUES, FROM THE LIFESCAN ULTRA 2 AND LIFESCAN ULTRALINK METERS, IN ADDITION TO THE PARADIGM LINK, LIFESCAN ULTRA AND FREESTYLE FLASH METERS.
P030025|S056|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2008|06/19/2008|||OK30|ADDITION OF A NEW COMPUTER ASSISTED LABEL INSPECTION SYSTEM.
P020009|S044|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 (MONORAIL AND OVER-THE-WIRE)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2008|06/19/2008|||OK30|ADDITION OF A NEW COMPUTER ASSISTED LABEL INSPECTION SYSTEM.
P040016|S031|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2008|06/19/2008|||OK30|ADDITION OF A NEW COMPUTER ASSISTED LABEL INSPECTION SYSTEM.
P860019|S226|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK, MAVERICK2, MAVERICK XL, QUANTUM MAVERICK|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2008|06/19/2008|||OK30|ADDITION OF A NEW COMPUTER ASSISTED LABEL INSPECTION SYSTEM.
P000029|S045|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2008|06/18/2008|||APPR|APPROVAL FOR INTRODUCING A QC (QUALITY CONTROL) SAMPLE AND A MS EXCEL CALCULATION TEMPLATE TO THE TEST METHOD FOR DETERMINING PROTEIN CONTENT IN HA (HYALURONIC ACID) RAW MATERIAL.
P990064|S024|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2008|07/15/2008|||APPR|APPROVAL FOR A REDUCTION OF THE RINSING TIME PRIOR TO IMPLANTATIONS OF THESE FOUR VALE MODELS.
P980043|S017|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHESIS|DYE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2008|07/15/2008|||APPR|APPROVAL FOR A REDUCTION OF THE RINSING TIME PRIOR TO IMPLANTATIONS OF THESE FOUR VALE MODELS.
P860057|S046|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/06/2008|||OK30|ADDITIONAL SUPPLIER FOR BOVINE PERICARDIAL TISSUE USED IN THE MANUFACTURE OF THE DEVICE.
P980035|S093|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/11/2008|||OK30|CHANGE TO THE MANUFACTURING TEST SOFTWARE FOR THE DEVICES.
P950037|S061|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2008|06/09/2008|||APPR|APPROVAL FOR MINOR MECHANICAL CHANGES TO THE ICS 3000 PROGRAMMER INCLUDING REMOVAL OF MAGNETS FROM THE PGH WAND AND REPLACEMENT OF AN EXISTING CONNECTOR AS WELL AS ASSOCIATED LABELING UPDATES.
P980023|S033|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2008|06/09/2008|||APPR|APPROVAL FOR MINOR MECHANICAL CHANGES TO THE ICS 3000 PROGRAMMER INCLUDING REMOVAL OF MAGNETS FROM THE PGH WAND AND REPLACEMENT OF AN EXISTING CONNECTOR AS WELL AS ASSOCIATED LABELING UPDATES.
P000009|S028|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PHYLAX AV ICD SYSTEM|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2008|06/09/2008|||APPR|APPROVAL FOR MINOR MECHANICAL CHANGES TO THE ICS 3000 PROGRAMMER INCLUDING REMOVAL OF MAGNETS FROM THE PGH WAND AND REPLACEMENT OF AN EXISTING CONNECTOR AS WELL AS ASSOCIATED LABELING UPDATES.
P880086|S163|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P050023|S013|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KRONOS LV-T CRT-D|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2008|06/09/2008|||APPR|APPROVAL FOR MINOR MECHANICAL CHANGES TO THE ICS 3000 PROGRAMMER INCLUDING REMOVAL OF MAGNETS FROM THE PGH WAND AND REPLACEMENT OF AN EXISTING CONNECTOR AS WELL AS ASSOCIATED LABELING UPDATES.
P010031|S099|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2008|07/18/2008|||APPR|APPROVAL FOR USE OF AN ALTERNATE SHELF PACKAGE CONFIGURATION FOR MEDTRONIC¿S CONCERTO CRT-D AND VIRTUOSO ICD DEVICES.
P970013|S024|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P980016|S130|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO DR/VR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2008|07/18/2008|||APPR|APPROVAL FOR USE OF AN ALTERNATE SHELF PACKAGE CONFIGURATION FOR MEDTRONIC¿S CONCERTO CRT-D AND VIRTUOSO ICD DEVICES.
P880006|S057|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P960013|S040|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P960030|S022|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|SJM LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P950022|S053|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|DURATA, RIATA ST OPTIM, RIATA ST, RIATA SF|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P030035|S042|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P030054|S089|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P910023|S176|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2008|06/09/2008|||OK30|CHANGE TO STERILIZE PRODUCTS FOR UP TO FIVE CYCLES AT THE CONTRACT STERILIZATION VENDOR.
P050006|S008|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2008|06/19/2008|||OK30|RELOCATION OF THE DELIVERY COMPONENTS MANUFACTURING PROCESS FROM ONE FACILITY TO ANOTHER WITHIN THE GORE MEDICAL FACILITY.
P930014|S025|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF UV ABSORBING INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2008|07/16/2009|||APPR|APPROVAL FOR CHANGES AND IMPROVEMENTS TO THE 8-CAVITY WAFER MOLDING MACHINE.
P910023|S177|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2008|06/19/2008|||OK30|ALTERNATE SUPPLIERS FOR DISCRETE COMPONENTS USED IN THE ASSEMBLY OF ICD AND CRT-D DEVICES.
P030054|S090|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2008|06/19/2008|||OK30|ALTERNATE SUPPLIERS FOR DISCRETE COMPONENTS USED IN THE ASSEMBLY OF ICD AND CRT-D DEVICES.
P030009|S024|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2008|06/06/2008|||OK30|REMOVAL OF SEVERAL VISUAL AND DIMENSIONAL INSPECTION STEPS IN THE MANUFACTURE OF THE DEVICE.
P030054|S091|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE AND QUICKFLEX LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2008|06/11/2008|||OK30|USE OF A BOOT CLAMP MANUFACTURING TOOL FOR QUICKSITE AND QUICKFLEX LEADS.
P900056|S093|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2008|09/30/2008|||APPR|APPROVAL FOR A MANUFACTURING PROCESS CHANGE TO ELIMINATE A PARTS CLEANING PROCESS FOR SELECT COMPONENTS.
P910077|S087|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2008|06/26/2008|||APPR|APPROVAL FOR CHANGE TO THE LATITUDE COMMUNICATOR SOFTWARE MODEL 6482), VERSIONS 1.8 AND 2.2, AND THE LATITUDE INDUCTIVE COMMUNICATOR SOFTWARE (MODEL 6481) VERSION 1.4.
P980016|S131|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST, VISTUOSO, SECURA DR/VR & MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2008|06/19/2008|||OK30|MANUFACTURING PROCESS CHANGE FOR BOND PAD ARRAYS.
P010031|S100|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO, CONSULTA CRT-D & MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2008|06/19/2008|||OK30|MANUFACTURING PROCESS CHANGE FOR BOND PAD ARRAYS.
P980035|S094|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA & SENSIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2008|06/19/2008|||OK30|MANUFACTURING PROCESS CHANGE FOR BOND PAD ARRAYS.
P060001|S007|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTÉGÉ GPS AND PROTÉGÉ RX CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2008|06/26/2008|||OK30|MOVE MANUFACTURING OF A COMPONENT IN-HOUSE AND ADD AN ALTERNATE TENT COMPACTION METHOD.
P850079|S043|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON B SOFT HYDROPHILIC CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2008|07/02/2008|||OK30|ALTERNATE TINTING PROCESS.
P060033|S009|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2008|06/26/2008|||OK30|USE OF A CONICAL BASE SPRAY JAR ASSEMBLY WITHIN THE ENDEAVOR STENT MANUFACTURING PROCESS.
P000029|S046|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/27/2008|06/25/2008|||APPR|APPROVAL FOR CHANGES IN THE PRECAUTIONS AND DIRECTIONS FOR USE SECTIONS OF THE PACKAGE INSERT.
P970038|S012|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA ASSAY|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/2008|08/13/2008|||APPR|APPROVAL FOR THE ADDITION OF A CALIBRATION TRACEABLE TO THE WORLD HEALTH ORGANIZATION 1ST INTERNATIONAL REFERENCE PREPARATION 96/668 FOR THE ACCESS HYBRITECH FREE PSA ASSAY
P790018|S048|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2008|06/26/2008|||OK30|CHANGE IN RAW MATERIAL SUPPLIER.
P980041|S012|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|05/27/2008|07/28/2008|||APPR|APPROVAL FOR MODIFICATION OF THE DIRECTIONAL INSERT TO ADD AN IMPRECISION STATEMENT, SPECIFIC TO THE AUTO-DILUTION RANGE OF THE ACCESS AFP ASSAY.
P980035|S095|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/SENSIA/ VERSA FAMILY OF IMPLANTABLE PULSE GENERATORS (IPGS)|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2008|11/05/2008|||APPR|APPROVAL FOR A NEW WELD SYSTEM.
P020014|S018|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/27/2008|03/16/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970003|S099|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY PULSE GENERATORS|LYJ|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2008|10/09/2008|||APPR|APPROVAL FOR STERILIZATION OF MIXED LOADS.
P030017|S065|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/2008|06/15/2010|||APPR|APPROVAL FOR THE BIONIC NAVIGATOR SOFTWARE VERSION 1.2.
P980035|S096|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA & VERSA & SENSIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2008|06/25/2008|||OK30|REPLACEMENT OF EXISTING EPOXY DISPENSERS USED IN THE MANUFACTURE OF THE ADAPTA, VERSA, AND SENSIA IMPLANTABLE PULSE GENERATORS (IPGS).
P030009|S025|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2008|11/04/2008|||APPR|APPROVAL FOR THE AUTOMATION OF THE STENT SEGMENT LOADING PROCESS.
P060033|S010|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2008|11/04/2008|||APPR|APPROVAL FOR THE AUTOMATION OF THE STENT SEGMENT LOADING PROCESS.
P980018|S006|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEP TEST|MVC|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/28/2008|02/25/2010|||APPR|APPROVAL TO MARKET THE HERCEPTEST KIT FOR AUTOMATED LINK PLATFORMS AND THE CHANGES INVOLVED IN THE ASSAY PROCEDURE TO USE THE NEW INSTRUMENT, CHANGE IN THE QC PROCEDURE WITH REFERENCE TO CHROMOGEN, CHANGES IN THE CRITERIA REGARDING THE CONTROL TISSUE DURING QC AND CHANGES IN THE SPECIMEN PREPARATION.
P910023|S178|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/28/2008|06/13/2008|||APPR|APPROVAL FOR THE MODEL EX2000 V. 2.0 VERSION SOFTWARE FOR USE ON THE ST. JUDE MEDICAL MERLIN@HOME DM EX1200 DEVICE.
P030054|S092|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CADENCE FAMILY OF ICD¿S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/28/2008|06/13/2008|||APPR|APPROVAL FOR THE MODEL EX2000 V. 2.0 VERSION SOFTWARE FOR USE ON THE ST. JUDE MEDICAL MERLIN@HOME DM EX1200 DEVICE.
P810055|S072|ADVANCED MEDICAL OPTICS, INC.|1700 E. ST. ANDREW PLACE|P.O. BOX 25162|SANTA ANA|CA|92705|4933|intraocular lens|CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2008|07/02/2008|||OK30|IMPLEMENTATION OF THE MEASURING IOL QUALITY SYSTEM FOR DETERMINING OPTICAL PERFORMANCE OF IOLS MANUFACTURED AT THE FACILITY.
P050010|S002|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC L TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2008|10/14/2008|||APPR|APPROVAL FOR CHANGES TO THE MILLING FEED RATE AND TOOL SPEED FOR PROCESSES FOR THE PRODISC-L.
P040043|S023|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/2008|08/20/2008|||APPR|APPROVAL FOR THE DISTRIBUTION OF THE 2008 ANNUAL CLINICAL UPDATE TO PHYSICIAN USERS FOR THE DEVICE.
P910023|S179|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2008|07/09/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE MERLIN@HOME TRANSMITTER MODEL EX1200, WHICH REPLACE THE LCD TOUCH SCREEN WITH A MEMBRANE PANEL AND CONSOLIDATE INTERNAL CIRCUITRY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED AS MODEL EX1150.
P030054|S093|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2008|07/09/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE MERLIN@HOME TRANSMITTER MODEL EX1200, WHICH REPLACE THE LCD TOUCH SCREEN WITH A MEMBRANE PANEL AND CONSOLIDATE INTERNAL CIRCUITRY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED AS MODEL EX1150.
P030054|S094|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2008|06/27/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P070008|S003|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2008|06/24/2008|||APPR|APPROVAL FOR A DIODE CHANGE IN THE STRATOS LV AND LV-T CRT-PS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STRATOS LV CRT-P AND STRATOS LV-T CRT-P AND IS INDICATED FOR TREATMENT OF BRADYCARDIA IN HEART FAILURE PATIENTS.
P030035|S043|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2008|06/27/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P960058|S066|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2008|10/15/2008|||APPR|APPROVAL FOR AN IMPROVED AUTOMATED TEST SYSTEM FOR THE HIRES90K.
P070016|S001|WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/02/2008|11/26/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880006|S058|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2008|06/27/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880086|S164|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2008|06/27/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P840001|S114|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2008|07/01/2008|||OK30|AUTOMATION OF A MANUFACTURING PROCESS FOR THE RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS.
P910023|S180|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2008|06/27/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970004|S057|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II MODEL 3058 NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2008|06/27/2008|||OK30|ADDITION OF A REWORK PROCESS INVOLVING THE REMOVAL AND REPLACEMENT OF A CONNECTOR BLOCK.
P970013|S025|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2008|06/27/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P980035|S097|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC RELIA IMPLANTABLE PULSE GENERATOR AND MODEL SW010APPLICATION SOFTWARE|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/2008|11/26/2008|||APPR|APPROVAL FOR THE MEDTRONIC RELIA SERIES OF PULSE GENERATORS WHICH ARE RATE RESPONSIVE, MULTI-PROGRAMMABLE, SINGLE AND DUAL CHAMBER  DEVICES (MODELS REDR01, RED01, REVDD01, RESR01, RES01) AND THE ASSOCIATED SW010 APPLICATIONS SOFTWARE (VERSION 1.0).
P970018|S014|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/21/2008|11/07/2008|||APPR|APPROVAL FOR A DESIGN CHANGE TO IMPROVE SHIELDING OF THE HORIZONTAL INTERFACE BOARD AND ACCOMPANYING LABELING CHANGES TO CLARIFY PRECAUTIONS AND INSTRUCTIONS.
P980040|S024|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ONE PIECE SOFT ACRYLIC INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2008|06/23/2008|||OK30|CHANGE IN THE TUMBLING PROCESS TO IMPROVE PROCESS CONSISTENCY AND REDUCE MANUFACTURING COSTS.
P980035|S098|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2008|10/01/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PLEXUS-PENANG, PENANG, MALAYSIA, FOR THE TESTING, LABELING AND PACKAGING OF THE DEVICE.
P010031|S101|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2008|10/01/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PLEXUS-PENANG, PENANG, MALAYSIA, FOR THE TESTING, LABELING AND PACKAGING OF THE DEVICE.
P980016|S132|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2008|10/01/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PLEXUS-PENANG, PENANG, MALAYSIA, FOR THE TESTING, LABELING AND PACKAGING OF THE DEVICE.
P010012|S180|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL/VITALITY/LIVIAN/COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|07/02/2008|||OK30|REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.
P940031|S063|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR/DISCOVER/MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|07/02/2008|||OK30|REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.
P960040|S168|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY/CONFIENT/TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|07/02/2008|||OK30|REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.
P910077|S088|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|07/02/2008|||OK30|REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.
P030005|S052|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|07/02/2008|||OK30|REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.
P810002|S065|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|11/05/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN ST. PAUL, MINNESOTA.
P050038|S006|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|07/03/2008|||OK30|CHANGE TO INCORPORATE A VALVE ASSEMBLY TO THE CAP TIP OF THE BELLOWS APPLICATOR WHICH CONTAIN ARISTA¿ AH ABSORBABLE HEMOSTAT.
P980016|S133|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR & MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|07/02/2008|||OK30|CHANGE THE TEST FACILITY LOCATION FOR TESTING THE GEN2 RF MODULE COMPONENT.
P010031|S102|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D & MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2008|07/02/2008|||OK30|CHANGE THE TEST FACILITY LOCATION FOR TESTING THE GEN2 RF MODULE COMPONENT.
P950037|S062|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SELOX SR/ST/JT, SETROX S, AND DEXTRUS STEROID-ELUTING LEADS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2008|07/01/2011|||APPR|APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR.
P040044|S009|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2008|07/01/2008|||OK30|ALTERNATE SUPPLIER FOR RAW MATERIALS FOR THE MYNX VASCULAR CLOSURE DEVICE.
P980023|S034|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|KENTROX SL/SL-S/RV/RV-S & LINOX S/SD/T/TD STEROID-ELUTING LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2008|07/01/2011|||APPR|APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR.
P050023|S014|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|COROX OTW UP STEROID-ELUTING LEAD|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2008|07/01/2011|||APPR|APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR.
P070008|S004|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW (-S) BP STEROID-ELUTING LEADS|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2008|07/01/2011|||APPR|APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR.
P030006|S018|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2008|10/16/2008|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE PORLIEVE¿ HEAT EXCHANGER CARTRIDGE ASSEMBLY METHOD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROLIEVE¿ THERMODILITATION SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN.
P920023|S025|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|AMS UROLUME ENDOPROSTHESIS|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2008|06/27/2008|||OK30|CHANGE IN VENDOR FOR THE PLASTIC INJECTION MOLDED PARTS OF THE DEVICE AND THE ADDITION OF AN IN-PROCESS PULL-OUT TEST TO THE CURRENT MANUFACTURING PROCEDURE.
P060037|S003|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LEGACY KNEE ¿ POSTERIOR STABILIZED (LPS), LPS-FLEX MOBILE BEARING KNEE|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2008|12/16/2008|||APPR|APPROVAL FOR THE MANUFACTURING PROCESSES UTILIZED DURING LIQUID PENETRANT INSPECTION OF COMPONENTS OF THE DEVICE.
P960009|S052|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC IMPLANTABLE NEUROSTIMULATION SYSTEM|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/2008|04/07/2009|||APPR|APPROVAL FOR NEW ACTIVA PC IMPLANTABLE NEUROSTIMULATION SYSTEM (INS), INTENDED FOR DEEP BRAIN STIMULATION (DBS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME ACTIVA PC AND IS INDICATED FOR THE FOLLOWING:PARKINSON'S CONTROL THERAPYBILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN)USING MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPARESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.TREMOR CONTROL THERAPYUNILATERAL THALAMIC STIMULATION BY THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM IS INDICATED FOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY. THE SYSTEM IS INTENDED FOR USE INPATIENTS WHO ARE DIAGNOSED WITH ESSENTIAL TREMOR OR PARKINSONIAN TREMOR NOT ADEQUATELYCONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.
P010003|S012|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE|MUQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2008|06/24/2008|||OK30|ADDITION OF AN AUTOMATED PUMP FOR DISPENSING BOVINE SERUM ALBUMIN AND GLUTERALDEHYDE IN THE MANUFACTURE OF BIOGLUE® SURGICAL ADHESIVE.
P990013|S021|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2008|07/11/2008|||OK30|MODIFICATION TO THE BASE BLOCKING PROCESS FOR ALL COLLAMER LENSES MANUFACTURED AT THE STAAR® SURGICAL AG FACILITY.
P030016|S008|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER|MTA|OP|30-Day Notice||N|06/06/2008|07/11/2008|||OK30|MODIFICATION TO THE BASE BLOCKING PROCESS FOR ALL COLLAMER LENSES MANUFACTURED AT THE STAAR® SURGICAL AG FACILITY.
P040024|S023|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/09/2008|09/29/2008|||APPR|APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT INCLUDED INFORMATION REGARDING INCREASED DURATION OF DEVICE EFFECTIVENESS.
P980016|S134|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2008|07/25/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE 9-PIN FILTERED FEEDTHROUGH USED IN VARIOUS FAMILIES OF MEDTRONIC ICD AND CRT-D DEVICES.
P010031|S103|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2008|07/25/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE 9-PIN FILTERED FEEDTHROUGH USED IN VARIOUS FAMILIES OF MEDTRONIC ICD AND CRT-D DEVICES.
P010054|S009|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS CALCHECK|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2008|07/09/2008|||APPR|APPROVAL FOR THE INTRODUCTION OF THE ELECSYS ANTI-HBS CALCHECK FOR USE WITH THE ELECSYS ANTI-HBS TEST SYSTEM.  THE ELECSYS ANTI-HBS CALCHECK IS USED FOR THE VERIFICATION OF THE CALIBRATION ESTABLISHED WITH THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS.  THE ELECSYS ANTI-HBS CALCHECK IS NOT A CALIBRATOR.
P070007|S001|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2008|06/27/2008|||APPR|APPROVAL FOR USE OF THE NEW XCELERANT DELIVERY SYSTEM WITH THE TALENT THORACIC STENT GRAFT.
P040038|S013|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2008|11/10/2008|||APPR|APPROVAL TO MOVE THE XACT MANUFACTURING PROCESSES WITHIN THE EXISTING MANUFACTURING FACILITY AND TO MOVE TWO PIECES OF DUPLICATE MANUFACTURING EQUIPMENT FROM ONE BUILDING TO ANOTHER.
P950034|S031|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/09/2008|06/20/2008|||APPR|APPROVAL FOR THE ADDITION OF VISUAL REPRESENTATIONS OF THE DIRECTIONS FOR USE SECTION OF THE CURRENT APPROVED PACKAGE INSERT.
P010031|S104|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2008|08/28/2008|||APPR|APPROVAL FOR THE RV LEAD INTEGRITY ALERT (RVLIA) FEATURE AND MODEL SW012, VERSION 1.0, RVLIA SOFTWARE.
P980016|S135|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2008|08/28/2008|||APPR|APPROVAL FOR THE RV LEAD INTEGRITY ALERT (RVLIA) FEATURE AND MODEL SW012, VERSION 1.0, RVLIA SOFTWARE.
P890003|S140|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|2490C CARELINK MONITOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2008|07/10/2008|||OK30|CHANGE TO ELIMINATE THE ESS TEST.
P010033|S013|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON - TB GOLD-IN-TUBE|NCD|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2008|10/31/2008|||APPR|APPROVAL FOR THE ADDITION OF QUANTIFERON BLOOD COLLECTION TUBES SUITABLE FOR USE AT ALTITUDES ABOVE 6,500 FEET.
P060027|S001|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2008|09/10/2008|||APPR|APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS.
P980016|S136|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2008|07/10/2008|||OK30|CHANGE TO THE MANUFACTURING TEST SOFTWARE FOR THE DEVICE.
P010031|S105|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2008|07/10/2008|||OK30|CHANGE TO THE MANUFACTURING TEST SOFTWARE FOR THE DEVICE.
P900022|S011|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|CHORUS PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2008|09/10/2008|||APPR|APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS.
P030011|S003|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|CARDIOWEST TEMPORARY TOTAL ARTIFICAL HEART (TAH-T) SYSTEM|LOZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/10/2008|08/11/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P980049|S037|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2008|09/10/2008|||APPR|APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS.
P010032|S026|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION (IPG) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2008|07/29/2008|||APPR|APPROVAL FOR ANS TRIPOLE 16 LAMITRODE LEAD MODELS 218, 3219, 3220, AND 3221.
P000032|S028|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/2008|03/27/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE LABELING THE HER OPTION TO INCLUDE THE RESULTS OF THE CLINICAL STUDY CONDUCTED TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF THE EXTENDED TREATMENT REGIMEN (ETR).
P950029|S036|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2008|09/10/2008|||APPR|APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS.
P070008|S005|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW (-S) BP LEFT VENTRICULAR LEADS|NKE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/11/2008|11/06/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010014|S020|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE (OXFORD PARTIAL KNEE SYSTEM)|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2008|09/18/2008|||APPR|APPROVAL FOR A CHANGE IN CLEANING AGENT USED IN THE INTERMEDIATE WASH PROCESS.
P050037|S008|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2008|07/11/2008|||OK30|CHANGE IN THE LOCATION OF THE CONTRACT MANUFACTURER OF THE RAW MATERIAL USED IN RADIESSE.
P050052|S009|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2008|07/11/2008|||OK30|CHANGE IN THE LOCATION OF THE CONTRACT MANUFACTURER OF THE RAW MATERIAL USED IN RADIESSE.
P860003|S048|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/2008|03/20/2009|||APPR|APPROVAL FOR ENGINEERING AND DESIGN CHANGES TO THE UVAR XTSPHOTOPHERESIS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETHERAKOS CELLEX PHOTOPHERESIS SYSTEM, AND IS INDICATED FOR USE IN THE ULTRAVIOLET-A(UVA) IRRADIATION, IN THE PRESENCE OF THE PHOTOACTIVE DRUG 8-METHOXYPSORALEN (8-MOP), OFEXTRACORPOREALLY CIRCULATING LEUKOCYTE-ENRICHED BLOOD, IN THE PALLIATIVE TREATMENT OF THE SKINMANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA (CTCL), IN PERSONS WHO HAVE NOT BEEN RESPONSIVE TO OTHER FORMS OF TREATMENT.
P860057|S047|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2800 AND 2800TFX|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2008|07/08/2008|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED SEAMLINE STITCH PROCESS.
P840001|S115|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREULTRA RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2008|07/11/2008|||OK30|ADDITION OF AN AUTOMATED CUTTING MACHINE AND THE ADDITION OF VISUAL INSPECTION STEPS.
P860047|S021|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT|LZP|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2008|07/10/2008|||APPR|APPROVAL FOR EXTENSION OF THE SHELF LIFE OF OCUCOAT FROM ONE TO THREE YEARS.
P980016|S137|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR & MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2008|07/11/2008|||OK30|MODIFICATIONS TO THE LASER RIBBON BONDING EQUIPMENT.
P010031|S106|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D & MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2008|07/11/2008|||OK30|MODIFICATIONS TO THE LASER RIBBON BONDING EQUIPMENT.
P910066|S025|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/12/2008|12/24/2008|||APPR|APPROVAL FOR UPGRADES TO THE OL1000 SINGLE COIL, SIZE 1 MODEL AND THE MICROPROCESSOR-CONTROLLER (CONTROL BOX) USED FOR THE OL1000 SINGLE COIL, SIZE 1 MODEL.
P890003|S141|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR AND CARDIOSIGHT READER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/2008|07/08/2008|||APPR|APPROVAL FOR THE CHANGES MADE TO THE MODEL 2490G MEDTRONIC CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AS FOLLOWS: 1) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE REVEAL XT AND REVEAL DX TO THE MODEL 2490G CARELINK MONITOR.2) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR TO ALLOW THE MONITOR TO FACILITATE RESETTING FIVE OF THE EIGHT NOTIFICATIONS OF THE MODEL 9529 REVEAL XT USED IN CONJUNCTION WITH THE MODEL 9539 REVEAL PATIENT ASSISTANT.3) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR AS A PREVENTATIVE MEASURE, TO RESOLVE AN INCONSISTENCY WHICH COULD POTENTIALLY CAUSE AN INVALID CARELINK TRANSMISSION TO BE SENT TO THE CARELINK NETWORK. 4) UPDATED THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO SUPPORT THE MODEL 9529 REVEAL XT AND THE MODEL 9528 REVEAL DX INSERTABLE CARDIAC MONITORS.
P000029|S047|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|07/10/2008|||OK30|CHANGE IN A SAMPLING PLAN FOR COMPRESSED AIR.
P830055|S103|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM ¿ MBT REVISION TIBIAL TRAYS|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|07/16/2008|||APPR|APPROVAL FOR AN ADDITIONAL IN-PROCESS INSPECTION TO MEASURE THE THICKNESS OF THE MBT REVISION TIBIAL TRAYS.  THESE MEASUREMENTS ARE TO ENSURE PROPER IDENTIFICATION OF THE PARTS.
P060027|S002|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT-D SYSTEM|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/13/2008|10/31/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P920015|S045|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE LEAD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|11/14/2008|||APPR|APPROVAL FOR A CHANGE IN THE TREATMENT PROCESS FOR THE LEAD SILICONE TUBING.
P030054|S095|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|07/09/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TORQUE WRENCH ACCESSORY USED WITH ICDS, CRT-DS, CRT-PS, AND PACEMAKERS.
P910023|S181|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|07/09/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TORQUE WRENCH ACCESSORY USED WITH ICDS, CRT-DS, CRT-PS, AND PACEMAKERS.
P030035|S044|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|07/09/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TORQUE WRENCH ACCESSORY USED WITH ICDS, CRT-DS, CRT-PS, AND PACEMAKERS.
P880006|S059|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|07/09/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TORQUE WRENCH ACCESSORY USED WITH ICDS, CRT-DS, CRT-PS, AND PACEMAKERS.
P880086|S165|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|07/09/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TORQUE WRENCH ACCESSORY USED WITH ICDS, CRT-DS, CRT-PS, AND PACEMAKERS.
P970013|S026|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2008|07/09/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TORQUE WRENCH ACCESSORY USED WITH ICDS, CRT-DS, CRT-PS, AND PACEMAKERS.
P980035|S099|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG)|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2008|07/01/2008|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE FOR THE MIXED MODE L363 INTEGRATED CIRCUIT (IC) USED IN THE MEDTRONIC ADAPTA, VERSA, AND SENSIA FAMILY OF PACEMAKERS.
P910023|S182|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2008|07/17/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE SEPTUM ASSEMBLY.
P950032|S048|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/16/2008|||OK30|CHANGE TO AUTOMATE MEDIA EXCHANGES DURING THE MANUFACTURING OF APLIGRAF® BI-LAYERED SKIN CONSTRUCT.
P030002|S016|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|NAA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/11/2008|||OK30|ADDITION OF AN ALTERNATIVE OPTICAL BENCH.
P030054|S096|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2008|07/17/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE SEPTUM ASSEMBLY.
P810002|S066|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/16/2008|||OK30|USE OF NEW AUTOCLAVES AND A REVISED STEAM STERILIZATION LOAD CONFIGURATION.
P920015|S046|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/17/2008|||OK30|MOVING MANUFACTURING LOCATIONS WITHIN THE SAME FACILITY.
P980050|S034|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SVC/CS TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/17/2008|||OK30|MOVING MANUFACTURING LOCATIONS WITHIN THE SAME FACILITY.
P900061|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL TRANSVENE LEAD AND RELATED ACCESSORIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/17/2008|||OK30|MOVING MANUFACTURING LOCATIONS WITHIN THE SAME FACILITY.
P890003|S142|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|LEADS SERVICE KIT & LEADS WRENCH KIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/17/2008|||OK30|MOVING MANUFACTURING LOCATIONS WITHIN THE SAME FACILITY.
P950024|S011|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR & BIPOLAR LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/17/2008|||OK30|MOVING MANUFACTURING LOCATIONS WITHIN THE SAME FACILITY.
P030036|S007|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|LEAD ASSEMBLY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/17/2008|||OK30|MOVING MANUFACTURING LOCATIONS WITHIN THE SAME FACILITY.
P010015|S044|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LEAD ASSEMBLY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/17/2008|||OK30|MOVING MANUFACTURING LOCATIONS WITHIN THE SAME FACILITY.
P040024|S024|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2008|07/15/2008|||OK30|CHANGES TO THE SAMPLING PLAN FOR COMPRESSED AIR.  THE CHANGES CONSIST OF A DECREASE IN THE NUMBER OF SAMPLING POINTS, A DECREASE IN THE FREQUENCY OF TESTING, AND THE ELIMINATION OF TESTING PARAMETERS.
P010012|S181|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/18/2008|||OK30|ADDITION OF A VERIFICATION INSPECTION TO THE PG FINAL PACKAGING MANUFACTURING LINE.
P030005|S053|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/18/2008|||OK30|ADDITION OF A VERIFICATION INSPECTION TO THE PG FINAL PACKAGING MANUFACTURING LINE.
P910077|S089|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK MINI & CONTAK RENEWAL 3|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/18/2008|||OK30|ADDITION OF A VERIFICATION INSPECTION TO THE PG FINAL PACKAGING MANUFACTURING LINE.
P940031|S064|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR & DISCOVER/MERIDIAN, PDP|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/18/2008|||OK30|ADDITION OF A VERIFICATION INSPECTION TO THE PG FINAL PACKAGING MANUFACTURING LINE.
P960040|S169|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/18/2008|||OK30|ADDITION OF A VERIFICATION INSPECTION TO THE PG FINAL PACKAGING MANUFACTURING LINE.
P980035|S100|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA/ENPULSE II/ADAPTA/VERSA/SENIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/18/2008|||OK30|AUTOMATION OF A CAPACITANCE TESTING OPERATION.
P970012|S035|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/18/2008|||OK30|AUTOMATION OF A CAPACITANCE TESTING OPERATION.
P010015|S045|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/18/2008|||OK30|AUTOMATION OF A CAPACITANCE TESTING OPERATION.
P980022|S029|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2008|07/17/2008|||OK30|CHANGES TO THE GLUCOSE SENSOR¿S ADHESION PROMOTER AND SENSOR ALIGNMENT PROCESS.
P010014|S021|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE|NRA|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/2008|08/15/2008|||APPR|APPROVAL FOR THE ADDITION OF COMPUTER AIDED SURGERY (CAS) NAVIGATION SURGICAL INSTRUMENTS FOR USE WITH THE BRAINLAB UNI-KNEE IMAGE GUIDANCE SYSTEM FOR USE WITH THE OXFORD PARTIAL KNEE SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OXFORD PARTIAL KNEE SYSTEM AND IS INTENDED FOR USE IN INDIVIDUALS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND IS INTENDED TO BE IMPLANTED WITH BONE CEMENT.
P010012|S182|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY SPIRAL LEAD|LWP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/17/2008|06/25/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880090|S025|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|POLYMETHYLMETHA-CRYLATE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2008|07/16/2008|||OK30|USE OF AN ALTERNATE STERILIZATION CHANGE AT THE STERIS-ISOMEDIX FACILITY.
P840039|S057|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2008|07/16/2008|||OK30|USE OF AN ALTERNATE STERILIZATION CHANGE AT THE STERIS-ISOMEDIX FACILITY.
P910061|S017|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SILICONE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2008|07/16/2008|||OK30|USE OF AN ALTERNATE STERILIZATION CHANGE AT THE STERIS-ISOMEDIX FACILITY.
P860047|S022|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2008|07/16/2008|||OK30|USE OF AN ALTERNATE STERILIZATION CHANGE AT THE STERIS-ISOMEDIX FACILITY.
P010012|S183|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL FAMILY OF CRT-D|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2008|07/30/2009|||APPR|APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.34 FOR THE CONTAK RENEWAL (MODEL H135), CONTAK RENEWAL 3 (MODELS H170, H175), CONTAK RENEWAL 3 HE (MODELS H177, H179), CONTAK RENEWAL 3 RF (MODELS H210, H215, H250, H255), AND CONTAK RENEWAL 3 RF HE (MODELS H217, H219, H257, H259).
P050012|S015|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2008|07/16/2008|||OK30|CHANGE TO EXTEND THE CURING TIME OF THE SENSOR SUB-ASSEMBLY.
P860057|S048|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2008|07/10/2008|||OK30|USE OF A NEW POUCH SEALER MACHINE.
P870077|S028|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE  BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2008|07/10/2008|||OK30|USE OF A NEW POUCH SEALER MACHINE.
P000007|S017|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2008|07/10/2008|||OK30|USE OF A NEW POUCH SEALER MACHINE.
P010041|S016|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2008|07/10/2008|||OK30|USE OF A NEW POUCH SEALER MACHINE.
P870056|S029|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2008|07/10/2008|||OK30|USE OF A NEW POUCH SEALER MACHINE.
P980035|S101|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG) PRODUCT FAMILY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2008|07/18/2008|||OK30|CHANGE IN VENDOR FOR SELECTED INTEGRATED CIRCUITS (ICS) USED IN THE HYBRIDS FOR MANUFACTURING THE ADAPTA, VERSA, AND SENSIA IMPLANTABLE PULSE GENERATORS (IPGS).
P980035|S102|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC ADAPTA, VERSA AND SENSIA PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2008|11/19/2008|||APPR|APPROVAL FOR A REDUCTION IN THE HYBRID BURN-IN STRESS TIME FOR THE ADAPTA, VERSA, AND SENSIA PACEMAKERS.
P990066|S031|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2008|07/16/2008|||OK30|CHANGE TO SPLIT THE MANUFACTURING PROCESS INTO TWO SEPARATE PARALLEL LINES.
P860003|S049|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/23/2008|08/29/2008|||APPR|APPROVAL FOR A MATERIAL CHANGE FOR THE GASKET USED IN THE CENTRIFUGE BOWL COVER OF THE UVAR XTS PHOTOPHERESIS SYSTEM.
P040024|S025|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2008|07/23/2008|||OK30|QUALIFICATION OF THE HELOS/QUIXEL LASER DIFFRACTION PARTICLE SIZE ANALYZER.
P950029|S037|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR|NVZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2008|07/23/2008|||APPR|APPROVAL FOR MANUFACTURING PROCESS CHANGES ENHANCING THE QUALITY CONTROLS PERTAINING TO SYMPHONY AND RHAPSODY PACEMAKERS AS WELL AS OVATIO ICD AND CRT-D SYSTEM DEVICES.
P980049|S038|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR & DR|MRM|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2008|07/23/2008|||APPR|APPROVAL FOR MANUFACTURING PROCESS CHANGES ENHANCING THE QUALITY CONTROLS PERTAINING TO SYMPHONY AND RHAPSODY PACEMAKERS AS WELL AS OVATIO ICD AND CRT-D SYSTEM DEVICES.
P060027|S003|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT|NIK|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2008|07/23/2008|||APPR|APPROVAL FOR MANUFACTURING PROCESS CHANGES ENHANCING THE QUALITY CONTROLS PERTAINING TO SYMPHONY AND RHAPSODY PACEMAKERS AS WELL AS OVATIO ICD AND CRT-D SYSTEM DEVICES.
P010012|S184|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-D PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2008|07/23/2008|||OK30|CHANGE IN THE WELDING PARAMETERS FOR THE CATHODE WELD.
P960040|S170|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICD PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2008|07/23/2008|||OK30|CHANGE IN THE WELDING PARAMETERS FOR THE CATHODE WELD.
P050038|S007|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|06/17/2008|07/02/2008|||APPR|APPROVAL FOR THE ADDITION OF A NEW TRADE NAME.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITASURE AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL AND OPHTHALMIC) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIAL BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P000025|S035|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/25/2008|12/19/2008|||APPR|APPROVAL FOR THE MAESTRO SYSTEM SOFTWARE VERSION 3.0 AS EXTERNAL SOFTWARE FOR USE WITH THE MED-EL COMBI 40+ COCHLEAR IMPLANT  SYSTEM, INCLUDING REMOVAL OF THE CURRENT RESTRICTION REGARDING USE OF THE FSP CODING STRATEGY BY INEXPERIENCED ADULT USERS.
P040024|S026|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|07/15/2008|||APPR|APPROVAL FOR THE ADDITION OF THE FOLLOWING CHANGES TO THE PRODUCT SPECIFICATIONS FOR THE PHOSPHATE BUFFER CONCENTRATE: 1) TO NARROW THE SPECIFICATION LIMIT FOR THE CONCENTRATION OF THE BUFFERING IONS IN THE PHOSPHATE BUFFER TO 23.4 ¿ 28.4 MG/ML FOR THE POTASSIUM DIHYDROGEN PHOSPHATE CONTENT AND TO 131-157 MG/ML FOR THE DISODIUM HYDROGEN PHOSPHATE CONTENT; 2) TO ADD THE BACTERIAL ENDOTOXIN TEST TO THE PHOSPHATE BUFFER CONCENTRATE SPECIFICATION; AND 3) TO ADD THE PH TEST TO THE PHOSPHATE BUFFER SPECIFICATION.
P990004|S014|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE & U.S.P./SURGIFLO HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|07/25/2008|||OK30|CHANGE IN THE LOAD CONFIGURATION FOR THE STERILIZATION PROCESS.
P000025|S036|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|08/27/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN INNSBRUCK, AUSTRIA.
P890003|S143|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/THERA I IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P980035|S103|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P980016|S138|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P010015|S046|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC CRT-P & INSYNC III CRT-P|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P010031|S107|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC CRT-D, CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P970012|S036|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P040001|S011|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP IPD SYSTEM|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/26/2008|01/14/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040020|S011|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR SINGLE-PIECE INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|07/30/2008|||OK30|MODIFIED FINAL CLEANING PROCESS.
P990066|S032|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/2008|07/30/2008|||APPR|APPROVAL OF MODIFICATIONS TO THE LABELING REGARDING THE PLACEMENT OF THE LATERALITY AND VIEW MARKER (APPROVED UNDER P990066/S022).
P030017|S067|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|07/30/2008|||OK30|ADDITION OF AN ALTERNATE LASER MARKER.
P040047|S006|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|07/30/2008|||OK30|ALTERNATE COMPONENT DRYING METHOD.
P040047|S007|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|07/24/2008|||OK30|CHANGES IN THE METHOD USED TO MONITOR THE STERILIZATION CYCLE FOR THE COAPTITE® INJECTABLE IMPLANT FOR SOFT TISSUE AUGMENTATION.
P050037|S009|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|07/30/2008|||OK30|ELIMINATING THE USE OF BIOLOGICAL INDICATORS IN THE SECOND STERILIZATION CYCLE IN A SECOND AUTOCLAVE USED TO STERILIZE THE RADIESSE INJECTABLE IMPLANT.
P050052|S010|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|07/30/2008|||OK30|ELIMINATING THE USE OF BIOLOGICAL INDICATORS IN THE SECOND STERILIZATION CYCLE IN A SECOND AUTOCLAVE USED TO STERILIZE THE RADIESSE INJECTABLE IMPLANT.
P960009|S054|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA, KINETRA IMPLANTABLE NEUROSTIMULATOR|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|12/04/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P840001|S117|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY FAMILY OF NEUROSTIMULATORS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|12/04/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P020014|S019|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE AND DELIVERY SYSTEM|HHS|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|10/08/2008|||APPR|APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.
P070013|S001|COLBAR LIFESCIENCE LTD.|9 HAMENOFIM ST.||HERZLIYA||46733||Implant, dermal, for aesthetic use|EVOLENCE COLLAGEN DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2008|08/14/2008|||OK30|INCREASE IN PRODUCTION CAPACITY FOR THE DEVICE.
P030006|S019|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2008|08/13/2008|||APPR|APPROVAL FOR MODIFICATION AND REPLACEMENT OF THE THERMOELECTRIC CONTROLLER BOARD.
P040020|S012|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR IOLS +3.0 D|MFK|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2008|12/22/2008|||APPR|APPROVAL FOR THE ACRYSOF IQ RESTOR INTRAOCULAR LENS +3.0 ADD POWER.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTORINTRAOCULAR LENS +3.0D (MODELS SN6AD1 AND MN6AD1) AND IS INDICATED FOR PRIMARYIMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS INADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THIS LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P030039|S010|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2008|08/18/2008|||APPR|APPROVAL FOR MODIFICATION TO THE 3 ML SYRINGE FOR THE PEG COMPONENT OF THE 2 ML CONFIGURATION OF THE DEVICE.
P020026|S052|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2008|11/14/2008|||APPR|APPROVAL FOR REDUCTION IN A FINAL ACCEPTANCE ACTIVITY TEST.
P040002|S019|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOLOGIX, INC. POWERLINK SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2008|11/04/2008|||APPR|APPROVAL FOR THE 34MM INFRARENAL PROXIMAL CUFF ACCESSORY FOR THE POWERLINK SYSTEM.
P060040|S001|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2008|03/13/2009|||APPR|APPROVAL FOR NEW EXTERNAL PERIPHERALS TO PROVIDE POWER AND SUPPORT OPERATION FOR THE DEVICE.
P040036|S007|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC / ABLATION CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/01/2008|02/05/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050048|S001|BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2008|07/17/2008|||OK30|ADDITION OF A NEW FILLING MACHINE FOR USE IN THE MANUFACTURE OF FILLED POSITIVE AND NEGATIVE CONTROL VIALS AND CALIBRATOR VIALS.
P010020|S010|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2008|08/08/2008|||OK30|UTILIZATION OF AN ADDITIONAL FABRICATION SYSTEM IN THE MANUFACTURING PROCESS OF THE DEVICE.
P000053|S017|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2008|08/08/2008|||OK30|UTILIZATION OF AN ADDITIONAL FABRICATION SYSTEM IN THE MANUFACTURING PROCESS OF THE DEVICE.
P050007|S010|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEMS|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/2008|07/23/2008|||APPR|APPROVAL FOR LABELING ADDITIONS TO THE INSTRUCTIONS FOR USE.
P020009|S045|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2008|08/01/2008|||OK30|REMOVAL OF A REDUNDANT IN-PROCESS INSPECTION STEP.
P030025|S057|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2008|08/01/2008|||OK30|REMOVAL OF A REDUNDANT IN-PROCESS INSPECTION STEP.
P040016|S032|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2008|08/01/2008|||OK30|REMOVAL OF A REDUNDANT IN-PROCESS INSPECTION STEP.
P980016|S139|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR & MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2008|08/01/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS.
P010031|S108|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D & MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2008|08/01/2008|||OK30|CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS.
P980016|S140|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIS OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2008|01/06/2009|||APPR|APPROVAL FOR CHANGING THE MANUFACTURING PROCESS OF A RECTIFIER DIODE AND A THYRISTOR.
P010031|S109|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC FAMILIES OF ICD & CONCERTO ICD & CONSULTA CRT-D & MAXIMO II CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2008|01/06/2009|||APPR|APPROVAL FOR CHANGING THE MANUFACTURING PROCESS OF A RECTIFIER DIODE AND A THYRISTOR.
P000053|S018|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2008|07/31/2008|||OK30|IMPLEMENTATION OF AN ALTERNATE VENDOR TO SUPPLY A COMPONENT PART FOR THE MANUFACTURE OF THE DEVICES.
P980022|S030|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GST (MINILINK TRANSMITTER) & GSR (CGMS I PRO RECORDER)|MDS|CH|30-Day Notice||N|07/03/2008|07/17/2008|||OK30|CHANGE TO ELIMINATE THE HIT TEST SCREENING STEP FROM THE FINAL PACKAGING.
P860019|S227|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS|LOX|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2008|10/08/2008|||APPR|APPROVAL FOR MODIFICATION TO THE PROXIMAL WELD PROCESS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTUM MAVERICK BALLOON CATHETERS AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.  THE QUANTUM MAVERICK BALLOON CATHETER (BALLOON MODELS 2.0 MM ¿ 5.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
P060033|S011|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OTW & MULTI-EXCHANGE II (MX2) & RAPID EXCHANGE (RX) DELIVERY SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2008|03/02/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC CARDIOVASCULAR, REVASCULARIZATION & SURGICAL THERAPY IN BROOKLYN PARK, MINNESOTA, FOR PACKAGING AND LABEL REWORK OF THE DEVICE.
P050023|S015|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TUPOS LV/ATX, KRONOS LV-T, LUMAX 300/340 FAMILY OF ICDS AND CRT-DS|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2008|12/24/2008|||APPR|APPROVAL FOR CHANGES TO THE VISUAL INSPECTION CRITERIA FOR GLASS FEEDTHROUGHS USED IN BATTERIES.
P000009|S029|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMOS & TACHOS & BELOS FAMILY OF ICDS & XELOS DR-T|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2008|12/24/2008|||APPR|APPROVAL FOR CHANGES TO THE VISUAL INSPECTION CRITERIA FOR GLASS FEEDTHROUGHS USED IN BATTERIES.
P070007|S002|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/03/2008|09/03/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P810002|S067|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MASTERS SERIES AORTIC VALVED GRAFT (MODEL CAVGJ), AND THE SJM MASTERS HP VALVED GRAFT (MODEL VAVGJ)|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/03/2008|08/29/2008|||APPR|APPROVAL FOR A MODIFICATION TO THE PACKAGING FOR THE REFERENCED MODELS.
P960040|S171|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN FAMILY|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/03/2008|07/25/2008|||APPR|APPROVAL OR CHANGES TO THE PROGRAMMER SW MODEL 2868 V1.03 AND PSEUDO-CONSTANTS LOADED DURING MANUFACTURING OF THE DEVICES.
P010012|S185|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS FAMILY|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/03/2008|07/25/2008|||APPR|APPROVAL OR CHANGES TO THE PROGRAMMER SW MODEL 2868 V1.03 AND PSEUDO-CONSTANTS LOADED DURING MANUFACTURING OF THE DEVICES.
P980037|S026|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2008|08/04/2008|||OK30|MODIFICATION IN THE STERILIZATION MANUFACTURING PROCEDURE.
P010019|S010|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CIBA VISION LOTRAFILCON B & A SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2008|08/06/2008|||OK30|CHANGE IN THE PLASMA TREATMENT PROCESS, USING AN ALTERNATE GAS MIXTURE TO MAINTAIN UNINTERRUPTED STREAM OF PRODUCT INVENTORY.
P910071|S012|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL|LWL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2008|08/22/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PHARMPUR GMBH, KÖNIGSBRUNN, GERMANY.
P990020|S033|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2008|10/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC IRELAND, GALWAY, IRELAND.
P050020|S006|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2008|08/06/2008|||OK30|TRANSFER AN INSPECTION STEP TO STEVEN LABEL AND ALSO TO SEMI-AUTOMATE THE INSPECTION STEP.
P920015|S047|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2008|08/08/2008|||OK30|CHANGES IN THE FOLLOWING AREAS: 1) A CHANGE IN THE CHART RECORDER TO MONITOR THE STERILIZATION PROCESS; 2) A CHANGE IN ETHYLENE OXIDE (EO) STERILIZATION EXPOSURE TIME; AND 3) A CHANGE IN THE INSPECTION METHOD OF THE COATING ON THE INNER DIAMETER OF THE TUBING COMPONENT.
P060039|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2008|08/08/2008|||OK30|CHANGES IN THE FOLLOWING AREAS: 1) A CHANGE IN THE CHART RECORDER TO MONITOR THE STERILIZATION PROCESS; 2) A CHANGE IN ETHYLENE OXIDE (EO) STERILIZATION EXPOSURE TIME; AND 3) A CHANGE IN THE INSPECTION METHOD OF THE COATING ON THE INNER DIAMETER OF THE TUBING COMPONENT.
P060033|S012|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2008|08/08/2008|||OK30|EQUIPMENT MODIFICATION TO INCREASE THE CAPACITY AT THE PILLOW FORMING WORK STEP.
P070013|S002|COLBAR LIFESCIENCE LTD.|9 HAMENOFIM ST.||HERZLIYA||46733||Implant, dermal, for aesthetic use|EVOLENCE COLLAGEN FILLER|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/09/2008|09/15/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P040038|S014|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2008|02/23/2009|||APPR|APPROVAL FOR THE ADDITION OF A NEW RECEIVING INSPECTION PARAMETER.
P050017|S003|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2008|02/03/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK IRELAND, LTD., LIMERICK, IRELAND FOR MANUFACTURING AND FINAL MANUFACTURING TO INCLUDE LABELING AND PACKAGING, AND FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD., TULLAMORE, IRELAND.
P010013|S020|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2008|02/06/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT HOLOGIC CORPORATION, EL COYOL ALAJUELA, COSTA RICA.
P040005|S003|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2FISH PHARMDX KIT|MVD|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2008|10/10/2008|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1. LABELING CHANGE IN THE STEP 1 (PRE-TREATMENT) IN THE INSTRUCTIONS FOR USE TO INCLUDE ANALTERNATIVE METHOD TO HEAT THE PRE-TREATMENT BUFFER USING A MICROWAVE OVEN WITH BOILSENSOR CAPABILITY AS "WATER BATH" INDEPENDENTLY OF THE BUFFER START VOLUME ANDTEMPERATURE2. LABELING CHANGE IN THE STEP 2 (PEPSIN, READY-TO-USE) IN THE INSTRUCTIONS FOR USE TO INCLUDEAN ALTERNATIVE METHOD OF INCUBATION WITH PEPSIN USING A HEATING BLOCK, E.G. A HYBRIDIZER,AND INCUBATION AT 37°C AS AN ALTERNATIVE TO INCUBATION AT ROOM TEMPERATURE3. CHANGES IN REAGENT VOLUME AND VIAL SIZE FOR VIAL 1 AND VIAL 24. MODIFICATION OF SIGNAL COUNTING GUIDE TO INCLUDE UNDER-DIGESTED NUCLEI5. LABELING CHANGE IN THE INSTRUCTIONS FOR USE TO INCLUDE THE DAKO HYBRIDIZER AS ANALTERNATIVE TO THE USE OF HEATING BLOCK AND HYBRIDIZATION OVEN FOR DENATURATION ANDHYBRIDIZATION STEPS, RESPECTIVELY.
P990064|S025|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2008|08/07/2008|||OK30|ADDITIONAL RAW MATERIAL SUPPLIER.
P970031|S023|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2008|08/07/2008|||OK30|ADDITIONAL RAW MATERIAL SUPPLIER.
P990037|S026|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2008|08/07/2008|||OK30|CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS, AND A CHANGE IN THE MATERIALS USED IN ONE ACCESSORY COMPONENT (SMALL BORE APPLICATOR TIP).
P030031|S010|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEERABLE TIP CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2008|02/20/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE TIP ASSEMBLY.
P020026|S053|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM & RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2008|08/04/2008|||OK30|REMOVAL OF A STENT INSPECTION TEST USED IN THE MANUFACTURE OF THE CYPHER STENT.
P040036|S008|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEERABLE TIP CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2008|02/20/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE TIP ASSEMBLY.
P060033|S013|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/14/2008|09/16/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P060019|S005|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/2008|06/12/2009|||APPR|APPROVAL FOR USE OF THE COOL POINT PUMP AND TUBING SET TO PROVIDE IRRIGATION OF THE THERAPY COOL PATH ABLATION CATHETER AS WELL AS MODIFICATION TO THE IBI 1500T9 RF ABLATION GENERATOR TO FUNCTION WITH THE COOL POINT PUMP.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IBI-1500T9-CP RF ABLATION GENERATOR.
P060039|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC ATTAIN STARFIX|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/14/2008|02/02/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030047|S014|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2008|08/14/2008|||OK30|ADDITION OF A SET-UP VERIFICATION STEP IN THE SUPPORT MEMBER ASSEMBLY PROCESS.
P070015|S001|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/2008|10/01/2009|||APPR|APPROVAL TO UPDATE THE INSTRUCTIONS OF USE (IFU) AND PATIENT GUIDE WITH THE SPIRIT III CLINICAL TRIAL 2-YEAR DATA.
P980037|S027|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/2008|03/19/2009|||APPR|APPROVAL FOR THE ANGIOJET ULTRA CONSOLE SOFTWARE VERSION V1.1.
P030009|S026|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2008|09/11/2008|||APPR|APPROVAL FOR THE INTRODUCTION OF ADDITIONAL AUTOMATION TO THE BALLOON SUB-ASSEMBLY MANUFACTURING PROCESS FOR THE DEVICE.
P040025|S007|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP SYSTEM|MXM|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/2008|04/22/2009|||APPR|APPROVAL FOR DESIGN CHANGES ASSOCIATED WITH SOFTWARE UPGRADE FROM COOL-CAP 1.0 TO COOL-CAP 1.1, AS WELL AS ASSOCIATED LABELING CHANGES.
P980035|S104|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2008|08/14/2008|||OK30|USE OF AN ALTERNATE EPOXY AND MODIFICATION TO THE LASER RIBBON BONDING EQUIPMENT.
P010031|S110|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2008|08/14/2008|||OK30|USE OF AN ALTERNATE EPOXY AND MODIFICATION TO THE LASER RIBBON BONDING EQUIPMENT.
P990001|S038|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C-SERIES & T-SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2008|08/14/2008|||OK30|USE OF AN ALTERNATE EPOXY AND MODIFICATION TO THE LASER RIBBON BONDING EQUIPMENT.
P980016|S141|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2008|08/14/2008|||OK30|USE OF AN ALTERNATE EPOXY AND MODIFICATION TO THE LASER RIBBON BONDING EQUIPMENT.
P850035|S032|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2008|08/15/2008|||OK30|ADDITION OF A CONFORMAL COATING ADHESIVE TO THE ELECTRONIC PRINTED CIRCUIT BOARDS OF THE DEVICE.
P790005|S045|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2008|08/15/2008|||OK30|ADDITION OF A CONFORMAL COATING ADHESIVE TO THE ELECTRONIC PRINTED CIRCUIT BOARDS OF THE DEVICE.
P980016|S142|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR & MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2008|08/15/2008|||OK30|FIVE MODIFICATIONS TO THE FINAL FUNCTIONAL ELECTRICAL TESTING FOR THE DEVICES.
P010031|S111|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D & MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2008|08/15/2008|||OK30|FIVE MODIFICATIONS TO THE FINAL FUNCTIONAL ELECTRICAL TESTING FOR THE DEVICES.
P920014|S029|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE XVE LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/2008|03/13/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE EXTERNAL PERIPHERALS.
P030054|S097|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/17/2008|07/31/2008|||APPR|APPROVAL FOR THE MODEL EX3000 THREE-LEAD ECG CABLE.
P880091|S027|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2008|08/08/2008|||OK30|CHANGE IN PACKAGING MATERIALS.
P020036|S010|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T CONTROL NITINOL STENT SYSTEM|NIO|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2008|08/07/2008|||APPR|APPROVAL TO INCORPORATE A FUNCTIONAL TORQUE SPECIFICATION FOR THE SLIDER ASSEMBLY OF THE SMART CONTROL NITINOL STENT DELIVERY SYSTEM.
P960040|S172|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN HE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2008|08/14/2008|||OK30|CHANGES TO THE SOLDER BALL SHEAR INSPECTION TEST PROCESS.
P010012|S186|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS HE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2008|08/14/2008|||OK30|CHANGES TO THE SOLDER BALL SHEAR INSPECTION TEST PROCESS.
P070015|S002|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/18/2008|12/12/2008|||APPR|APPROVAL FOR AN 18-MONTH SHELF LIFE.
P060039|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN STARFIX|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/2008|01/16/2009|||APPR|APPROVAL FOR 1) USE OF NEW ANALYTICAL METHODS FOR ASSAY, CONTENT UNIFORMITY AND IDENTITY TESTING;2) TIGHTENING OF THE ASSAY SPECIFICATION RELATIVE TO THE LABEL CLAIM;3) MODIFICATION OF THE ELUTION SPECIFICATION WITH AN ADDITIONAL TIME POINT AND UPDATEDACCEPTANCE CRITERIA;4) MODIFICATION OF THE RESIDUAL SOLVENT SPECIFICATION;5) MODIFICATION OF THE APPEARANCE SPECIFICATION:6) USE OF A NEW LABORATORY FOR RELEASE AND STABILITY TESTING;7) USE OF NEW ASSAY, CONTENT UNIFORMITY, IDENTIFICATION, ELUTION AND RELATED SUBSTANCEANALYTICAL TEST METHODS DEVELOPED AT THE NEW LABORATORY;8) USE OF THE APPROVED APPEARANCE/ DESCRIPTION AND RESIDUAL SOLVENTS TEST METHODS AT THE NEW LABORATORY;9) USE OF THE NEW LABORATORY STERILITY TEST METHOD; AND10) UPDATE OF THE MODEL 4195 LEAD SHELF LIFE TO 12 MONTHS AND AGREEMENT THAT DRUG STABILITY DATA AT 18 MONTHS ARE ACCEPTABLE.
P900066|S008|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN PERFLUOROPROPANE C3F8|LPO|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2008|02/19/2009|||APPR|APPROVAL FOR CHANGE OF PERFLUOROPROPANE GAS SUPPLIER.
P980044|S007|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2008|07/07/2009|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE MANUFACTURING PROCESS: 1) REPLACEMENT OF WFI MANUFACTURING EQUIPMENT;2) ADDITION OF A SENSOR FOR PREVENTING DOUBLE CAPPING;3) REPLACEMENT OF THE MULTIPLEXER PROCESSOR;4) ADDITION OF A SYRINGE LABEL SENSOR;5) REPLACEMENT OF THE ELECTRONIC BALANCE;6) CHANGE OF KNOCKERS USED TO PUSH RUBBER PISTONS INTO GLASS SYRINGES DURING THE FILLINGMEDIA FILL TEST (MFT);7) ADDITION OF A SECOND FILTRATION TANK IN ORDER TO FACILITATE THE MANUFACTURING OF PLASTIC ANDGLASS SYRINGE PRODUCTS ON CONSECUTIVE DAYS; AND 8)  INSTALLATION OF A NEW STORAGE ROOM FOR RAW MATERIAL.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUPARTZ® AND IS INDICATED FORTHE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPONDADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G.,ACETAMINOPHEN.
P910077|S090|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2008|11/17/2008|||APPR|APPROVAL FOR THE NEXT GENERATION (G2) RF COMMUNICATOR, MODEL 6476, WHICH IN CONJUNCTION WITH THE LATITUDE SYSTEM SOFTWARE, V5.0, MODEL 6488, WILL ADD LATITUDE SUPPORT FOR COGNIS TELIGEN PGS.
P850035|S033|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)|LOE|OR|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/2008|09/18/2008|||APPR|APPROVAL FOR A CHANGE IN THE TRADE NAME WHICH WAS PREVIOUSLY APPROVED AS: SPF-PLUS (60/W) AND SPF- PLUS (60/M).  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) AND IS INDICATED AS A SPINAL FUSING ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS.
P970021|S021|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|THE GYNECARE THERMACHOICE* III|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|08/21/2008|||OK30|MODIFICATION TO A COMPONENT ASSEMBLY LOCATION.
P040002|S020|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|08/27/2008|||OK30|CHANGE IN ONE OF THE PARAMETERS USED IN THE GRAFT PROCESSING PROCEDURE OF THE POWERLINK SYSTEM.
P010012|S187|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL & LIVIAN FAMILY OF CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|08/21/2008|||OK30|CHANGE IN A MATERIAL SUPPLIER.
P960040|S173|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY HE & CONFIENT ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|08/21/2008|||OK30|CHANGE IN A MATERIAL SUPPLIER.
P980016|S143|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO/MAXIMO II DR/VR/MARQUIS/INTRINSIC/ENTRUST/VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|08/22/2008|||OK30|REQUESTED A NEW PHOTO DEVELOPER RECIPE.
P980035|S105|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|08/22/2008|||OK30|REQUESTED A NEW PHOTO DEVELOPER RECIPE.
P010031|S112|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC SENTRY FAMILY/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC MAXIMO FAMILY/CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|08/22/2008|||OK30|REQUESTED A NEW PHOTO DEVELOPER RECIPE.
P020014|S020|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM|HHS|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2008|09/11/2008|||APPR|APPROVAL FOR A MODIFICATION TO SPECIFICATIONS OF THE DRY FLOW INTRODUCER AND THE ADDITION OF A BACK-UP BOND IN THE DETACHMENT MECHANISM.
P910077|S091|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 6488|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2008|09/05/2008|||APPR|APPROVAL FOR CHANGES TO THE LATITUDE REGULATED APPLICATION SOFTWARE ON LATITUDE SYSTEM SERVER (MODEL 6488, VERSION 5.0).
P880091|S028|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL ELASTIC/ELASTIMIDE & ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|09/10/2008|||APPR|APPROVAL FOR ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING.
P990013|S022|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|09/10/2008|||APPR|APPROVAL FOR ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING.
P000026|S001|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||Intraocular pressure lowering implant|STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE|OGO|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|09/10/2008|||APPR|APPROVAL FOR ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING.
P030016|S009|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA|MTA|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2008|09/10/2008|||APPR|APPROVAL FOR ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING.
P910023|S183|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2008|11/26/2008|||APPR|APPROVAL FOR A CHANGE TO ELIMINATE A CHEMICAL CLEANING PROCESS FOR TITANIUM CASE HALVES.
P030054|S098|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2008|11/26/2008|||APPR|APPROVAL FOR A CHANGE TO ELIMINATE A CHEMICAL CLEANING PROCESS FOR TITANIUM CASE HALVES.
P960009|S055|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA THERAPY FOR DBS|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2008|10/17/2008|||APPR|APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY.
P970003|S100|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY PERENNIAFLEX|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/24/2008|12/19/2008|||APPR|APPROVAL FOR THE FOLLOWING MINOR MODIFICATIONS TO THE APPROVEDMODEL 303 STIMULATION LEAD (THE NEW MODEL TO BE REFERRED TO AS "304"):1)  CHANGING THE COIL MATERIAL TO ONE WITH A LOWER TITANIUM TOLERANCE (< 0.01%) TO IMPROVEFATIGUE RESISTANCE;2) CHANGING THE INSULATING MATERIAL TO ONE THAT IS SIMILAR, BUT WITH IMPROVED FATIGUE ANDABRASION RESISTANCE;3) ADDING A CONTROLLED FILLET TO THE ELECTRODE BIFURCATION TO IMPROVE FATIGUE RESISTANCE, AND4) ADDING AN INTERMEDIATE ELECTRODE SIZE (2.5 MM) THAT ALSO OFFERS NERVE COVERAGE >360 DEGREES.
P840001|S118|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2008|10/17/2008|||APPR|APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY.
P970004|S060|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2008|10/17/2008|||APPR|APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY.
P990034|S011|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED PUMP AND INFUSION SYSTEM|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2008|10/17/2008|||APPR|APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY.
P860004|S099|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PUMP & INFUSION SYSTEM|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2008|10/17/2008|||APPR|APPROVAL FOR THE IMPLEMENTATION OF THE STERILIZATION AUTOMATED RELEASE OR STAR SYSTEM TO THE STERILIZATION OPERATION AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE MANUFACTURING FACILITY.
P970021|S022|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|THE GYNECARE THERMACHOICE* III|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|08/25/2008|||OK30|CHANGE TO THE CURING SYSTEM IN THE CATHETER ASSEMBLY PROCESS.
P020026|S055|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|08/20/2008|||OK30|ALTERNATE TESTING LOCATION FOR A SET OF QUANTITATIVE TEST METHODS.
P970051|S046|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|08/29/2008|||OK30|CHANGE IN THE WELDING PROCEDURE FOR THE CI24R AND CI24RE DEVICES.
P040024|S027|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|08/22/2008|||OK30|CHANGE TO ELIMINATE THE EXTRUSION FORCE TEST FROM THE LONG TERM STABILITY TESTING PROGRAM FOR RESTYLANE® INJECTABLE GEL AND PERLANE® INJECTABLE GEL.
P980035|S106|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILY OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P010031|S113|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P010015|S047|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC & INSYNC III CRT-P|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P980016|S144|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P970012|S037|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR IPG & SR IPG PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P890003|S144|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/THERA I IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2008|11/05/2009|||APPR|APPROVAL FOR MULTI-BEAM CONTACT (MBC) RELATED MANUFACTURING PROCESS CHANGES.
P930014|S026|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF  POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2008|08/27/2008|||OK30|IMPROVED COATING PROCESS FOR THE ACRYSERT® DELIVERY SYSTEM.
P050010|S003|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC L TOTAL DISC REPLACEMENT|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2008|08/26/2008|||OK30|RELOCATION OF THE LASER ETCH MARKING.
P890003|S145|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|IMPLANTABLE PACEMAKER/ICD PROGRAMMER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P980016|S145|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P900061|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P850051|S068|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|PREVAIL|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P980050|S035|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P820003|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EXTERNAL PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P010015|S048|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC & INSYNC III CRT-P|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P980035|S107|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P930022|S007|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P970012|S038|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR & SR IPG PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P010031|S114|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILY OF ICDS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P990001|S039|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2008|11/21/2008|||APPR|APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE.  UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
P010012|S188|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 RF AND LIVIAN FAMILIES OF CRT-D|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/2008|08/28/2008|||APPR|APPROVAL FOR THE ADDITION OF POLYIMIDE TAPE TO THE WELD RING.
P020026|S056|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENTS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2008|08/28/2008|||OK30|ALTERNATE IN PROCESS QUALITY INSPECTION METHOD FOR THE DEVICE.
P070015|S003|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2008|08/28/2008|||OK30|REPLACEMENT OF THE EXITING MANUAL MANDREL REMOVAL PROCESS WITH A SEMI-AUTOMATED PROCESS.
P010012|S189|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-D|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2008|11/17/2008|||APPR|APPROVAL FOR THE NEXT GENERATION (G2) RF COMMUNICATOR, MODEL 6476, WHICH IN CONJUNCTION WITH THE LATITUDE SYSTEM SOFTWARE, V5.0, MODEL 6488, WILL ADD LATITUDE SUPPORT FOR COGNIS TELIGEN PGS.
P960040|S174|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2008|11/17/2008|||APPR|APPROVAL FOR THE NEXT GENERATION (G2) RF COMMUNICATOR, MODEL 6476, WHICH IN CONJUNCTION WITH THE LATITUDE SYSTEM SOFTWARE, V5.0, MODEL 6488, WILL ADD LATITUDE SUPPORT FOR COGNIS TELIGEN PGS.
P030054|S099|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2008|09/09/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.9.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030035|S045|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIERII FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2008|09/09/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.9.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880006|S060|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2008|09/09/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.9.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880086|S166|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2008|09/09/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.9.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P910023|S184|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2008|09/09/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.9.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970013|S027|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2008|09/09/2008|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 6.9.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030049|S002|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG  & CONFIRMATORY ASSAYS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/2008|09/25/2009|||APPR|APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HBSAG ASSAY AND THE ADVIACENTAUR HBSAG CONFIRMATORY ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THECENTAUR CP.ADVIA CENTAUR HBSAG READYPACK REAGENTS ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM.THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B INFECTION. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD.THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY READYPACK ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OFHBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIA CENTAUR HBSAG ASSAY.ADVIA CENTAUR HBSAG QUALITY CONTROLS ON THE CENTAUR CP ANALYZER:FOR MONITORING THE PERFORMANCE OF THE HBSAG AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBSAG QUALITY CONTROL MATERIAL HASNOT BEEN ESTABLISHED WITH ANY OTHER HBSAG OR HBSAG CONFIRMATORY ASSAYS.
P890003|S146|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK PROGRAMMER|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2008|01/30/2009|||APPR|APPROVAL FOR SEVERAL MODIFICATIONS TO THE DEVICE SPECIFICATION.
P980044|S008|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2008|08/29/2008|||OK30|UPDATING OF AN IN-PROCESS TEST INSTRUMENT.
P050039|S002|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2008|11/19/2008|||APPR|APPROVAL FOR THE ADDITION OF A NEW RAW MATERIAL SUPPLIER.
P030036|S008|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC SELECTSECURE MODEL 3830 LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2008|08/29/2008|||OK30|FACILITY TRANSFER OF A COMPONENT MANUFACTURER.
P040021|S007|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|SJM BIOCOR VALVE & SUPRA VALVE|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/2008|09/26/2008|||APPR|APPROVAL FOR THE SJM BIOCOR 25MM MITRAL VALVE SIZE AND THE EPIC 25 MM MITRAL VALVE SIZE.
P930014|S027|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF TORIC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2008|08/28/2008|||OK30|CHANGES TO THE BENCH QUALITY CONTROL INSPECTION SOFTWARE, THE USE OF A SEMI-AUTOMATED MOTORIZED ROTARY STAGE, AND OTHER LENS BENCH EQUIPMENT UPGRADES.
P010012|S190|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 3 IS-1 & LV-1|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2008|08/29/2008|||OK30|CHANGE IN A MATERIAL SUPPLIER.
P050046|S003|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE FAMILY OF LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2008|08/29/2008|||OK30|CHANGE IN A MATERIAL SUPPLIER.
P900023|S049|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|AB PORTABLE DRIVER|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/2008|03/17/2009|||APPR|APPROVAL FOR IN-HOSPITAL USE OF THE DEVICE.
P030035|S046|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-P|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|01/15/2009|||APPR|APPROVAL FOR A MANUFACTURING PROCESS CHANGE FOR HYBRID ASSEMBLY.
P880086|S167|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINTY/IDENTITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|01/15/2009|||APPR|APPROVAL FOR A MANUFACTURING PROCESS CHANGE FOR HYBRID ASSEMBLY.
P860004|S100|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/04/2008|09/03/2008|||APPR|APPROVAL FOR LABELING CHANGES FOR INTRATHECAL CATHETER MODELS 8709SC, 8731SC, 8578 AND 8596SC.
P050037|S011|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|10/16/2008|||OK30|INSTALLATION OF ADDITIONAL PACKAGING EQUIPMENT.
P050052|S012|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|10/16/2008|||OK30|INSTALLATION OF ADDITIONAL PACKAGING EQUIPMENT.
P050020|S007|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|08/25/2008|||OK30|CHANGE TO COMBINE THREE SEPARATE MANUAL PROCESSES INTO A SEMI-AUTOMATED PROCESS AND A  VENDOR CHANGE FROM ASAHI POLYSLIDER TO OBERG INDUSTRIES.
P050012|S016|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/2008|02/13/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE RECEIVER USER INTERFACE AND ALGORITHM, AND MODIFICATIONS TO THE TRANSMITTER TO MAKE IT COMPATIBLE TO THE MODIFIED RECEIVER ALGORITHM.
P040047|S008|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|09/02/2008|||OK30|INSTALLATION OF ADDITIONAL PACKAGING EQUIPMENT USED TO MANUFACTURE THE DEVICE.
P980035|S108|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|04/21/2009|||APPR|APPROVAL OF THE ADDITION OF AN ETHYLENE OXIDE STERILIZER.
P010015|S049|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC & INSYNC III CRT-P|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|04/21/2009|||APPR|APPROVAL OF THE ADDITION OF AN ETHYLENE OXIDE STERILIZER.
P010031|S115|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|04/21/2009|||APPR|APPROVAL OF THE ADDITION OF AN ETHYLENE OXIDE STERILIZER.
P970012|S039|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR & SR PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|04/21/2009|||APPR|APPROVAL OF THE ADDITION OF AN ETHYLENE OXIDE STERILIZER.
P980016|S146|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|04/21/2009|||APPR|APPROVAL OF THE ADDITION OF AN ETHYLENE OXIDE STERILIZER.
P990001|S040|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|04/21/2009|||APPR|APPROVAL OF THE ADDITION OF AN ETHYLENE OXIDE STERILIZER.
P990013|S023|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|09/04/2008|||OK30|CHANGE TO THE MODEL OF SILICONE/TEFLON SEPTA CURRENTLY USED TO MANUFACTURE COLLAMER¿ LENSES AT THE NIDAU, SWITZERLAND FACILITY.
P030016|S010|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL COLLAMER UV ¿ ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2008|09/04/2008|||OK30|CHANGE TO THE MODEL OF SILICONE/TEFLON SEPTA CURRENTLY USED TO MANUFACTURE COLLAMER¿ LENSES AT THE NIDAU, SWITZERLAND FACILITY.
P010031|S116|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2008|09/04/2008|||OK30|CHANGE IN MANUFACTURING TO MODIFY THE MAXIMO II DEVICES MEMORY FILES.
P980016|S147|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2008|09/04/2008|||OK30|CHANGE IN MANUFACTURING TO MODIFY THE MAXIMO II DEVICES MEMORY FILES.
P020047|S012|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION OTW FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2008|09/03/2008|||OK30|CHANGE IN RADIATION EQUIPMENT USED IN THE MANUFACTURE OF THE DEVICE.
P980049|S039|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ISOLINE 2CR|MRM|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2008|10/09/2008|||APPR|APPROVAL FOR A CHANGE TO THE FINISHED DEVICE ACCEPTANCE CRITERIA AND AN ASSOCIATED LABELING CHANGE IN THE SCREW MECHANISM TEST FOR THE ISOLINE PRODUCTS.
P970020|S052|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK OTW ZETA CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2008|09/03/2008|||OK30|CHANGE IN RADIATION EQUIPMENT USED IN THE MANUFACTURE OF THE DEVICE.
P980022|S031|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN INFUSINO PUMPS|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/06/2008|03/10/2010|||APPR|APPROVAL FOR THE SOFTWARE MODIFICATIONS FOR MODEL MMT-523, MMT-723, MMT-523K, AND MMT-723K PARADIGM REAL-TIME INSULIN PUMPS AS WELL AS NEW VERSIONS OF CARELINK PRO AND CARELINK PERSONAL ACCESSORY SOFTWARE THAT HAVE BEEN UPDATED TO SUPPORT THESE INSULIN PUMP MODELS.
P830055|S104|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/07/2008|10/10/2008|||APPR|APPROVAL FOR MODIFIED LCS TOTAL KNEE SYSTEM LABELING AND INSTRUMENTATION TO BE USED WITH BRAINLAB COMPUTER-AIDED NAVIGATION SOFTWARE DURING SURGICAL IMPLANTATION OF THE LCS TOTAL KNEE SYSTEM.
P030002|S017|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|NAA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2008|09/05/2008|||OK30|ADDITION OF AN ALTERNATE OPTICAL COMPARATOR.
P070015|S004|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V RX EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2008|09/05/2008|||OK30|CHANGE IN THE E-BEAM IRRADIATION EQUIPMENT USED DURING THE MANUFACTURING OF THE DEVICE.
P970051|S047|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2008|09/05/2008|||OK30|INTEGRATION OF THE WELDING PROCESS AND THE ADDITION OF A SECOND WELDING SYSTEM FOR THE CI24R AND CI24R DEVICES.
P910023|S185|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/11/2008|08/19/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE QUICKSTART GUIDE (LABELING FOR THE MERLIN@HOME DM EX1150 TRANSMITTER.)
P030054|S100|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/11/2008|08/19/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE QUICKSTART GUIDE (LABLEING FOR THE MERLIN@HOME DM EX1150 TRANSMITTER).
P930016|S031|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|VISX STAR S4 IR EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|12/01/2008|||APPR|APPROVAL FOR MODIFICATION OF THE STARPATIENT'S CHAIR. THE DEVICE, AS MODIFIED, WILL HE MARKETED UNDER THE TRADE NAME STAR S4IR EXCIMER LASER SYSTEM AND IS INDICATED FOR WAVE FRONT-GUIDED (WFG) LASER ASSISTED INSITU KERATOMILEUSIS (LAS1K) TO ACHIEVE MONOVISION BY THE TARGETED RETENTION OF MYOPIA(-1.25 TO -2.00 D) IN THE NON-DOMINANT EYE OF PRESBYOPIC MYOPES:1) 40 YEARS OR OLDER WHO MAY BENEFIT FROM INCREASED SPECTACLE INDEPENDENCE ACROSS A RANGE OF DISTANCES WITH USEFUL NEAR VISION;2) WITH MYOPIC ASTIGMATISM UP TO    -6.00 D MRSE. WITH CYLINDER UP TO -3.00 D, ANDMINIMUM PRE-OPERATIVE MYOPIA IN THEIR NON-DOMINANT EYE AT LEAST AS GREAT AS THEIRTARGETED MYOPIA;3) WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.50 D(IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OFPREOPERATIVE EXAMINATION; AND4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISIONEXPERIENCE.
P030029|S003|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR AHBS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/2008|07/31/2009|||APPR|APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR ANTI-HBS ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP.ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMANSERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS(HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICALMARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. AREACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS ANDSYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS ARE INTENDED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS ASSAY ON THE ADVIA CENTAUR SYSTEMS.  THE PERFORMANCE OF THE ADVIA CENTAUR ANTI-HBS QUALITY CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.
P910023|S186|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ALTERNATE VENDOR FOR A HYBRID COMPONENT.
P030054|S101|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ALTERNATE VENDOR FOR A HYBRID COMPONENT.
P900052|S016|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM|LNY|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|08/11/2008|04/20/2009|||APPR|APPROVAL FOR A LABEL CLAIM ¿DOES NOT CONTAIN NATURAL RUBBER LATEX.¿
P910023|S187|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|CHANGE IN THE REWORK PROCESS AND THE ADDITION OF A NEW PIECE OF EQUIPMENT.
P030054|S102|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|CHANGE IN THE REWORK PROCESS AND THE ADDITION OF A NEW PIECE OF EQUIPMENT.
P990027|S010|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/2008|05/18/2010|||APPR|APPROVAL FOR THE FOLLOWING CHANGES: 1) REMOVAL OF A REDUNDANT FLUENCE TEST;2) INTRODUCTION OF A NEW SCANNER SYSTEM FROM GSI TO THE LASER SYSTEM:3) EXTRAPOLATION OF THE WAVEFRONT DATA IN THE DIAGNOSTIC ZYWAVE SOFTWARE;4) NEW ZRS (ZYOPTIX REMOTE SUPPORT) SOFTWARE TO MONITOR THE PERFORMANCE OF THELASER AND DIAGNOSTIC DEVICES REMOTELY VIA THE INTERNET;5) MODIFICATION OF THE ZRS TO INCLUDE TRULINK, AN ENHANCEMENT TO THE ZRS SYSTEM;6) INTRODUCTION OF A NEW OP FIELD ILLUMINATION IN THE LASER SYSTEM;7) CHANGE OF THE VIDEO CHIP IN THE CCD LENSLET CAMERA DMK4002-IR; AND8) CHANGE IN THE SUPPLIER OF THE TEMPERATURE CONTROL UNIT IN THE LASER SYSTEM.
P790018|S049|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/09/2008|||OK30|CHANGE IN VENDOR FOR A SUTURE USED IN THE MANUFACTURE OF THE DEVICES.
P970031|S024|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/09/2008|||OK30|CHANGE IN VENDOR FOR A SUTURE USED IN THE MANUFACTURE OF THE DEVICES.
P980035|S109|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|12/24/2008|||APPR|APPROVAL FOR A CHANGE IN THE BARB FASTENER MANUFACTURING PROCESS.
P030040|S002|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/2008|10/20/2009|||APPR|APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HBC IGM ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBC IGM ASSAY AND IS INDICATED FOR:ADVIA CENTAUR HBC IGM READYPACK REAGENTS ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBC IGM ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION OF IGM RESPONSE TO HEPATITIS B VIRUS CORE ANTIGEN IN HUMAN SERUM ANDPLASMA (EDTA OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM.THE ASSAY USES RECOMBINANT HBC ANTIGEN. THIS ASSAY MAY BE USED IN COMBINATION WITHOTHER HEPATITIS B VIRUS (HBV) MARKER ASSAYS TO DEFINE THE CLINICAL STATUS OF KNOWN HBVINFECTED PATIENTS OR CAN BE COMBINED WITH OTHER HBV, HAV (HEPATITIS A VIRUS), AND HCV(HEPATITIS C VIRUS) ASSAYS FOR THE DIAGNOSIS OF PATIENTS PRESENTING SYMPTOMS OF ACUTE VIRAL HEPATITIS.  ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR IMMUNOCOMPRO-MISED ORIMMUNOSUPPRESSED PATIENTS, CORD BLOOD, NEONATAL SPECIMENS, INFANTS, OR CHILDREN.ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HBC IGM ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HBV SEROLOGICAL MARKERS.ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS ON THE CENTAUR CP ANALYZER:FOR MONITORING THE PERFORMANCE OF THE HBC IGM ASSAY USING THE ADVIA CENTAURSYSTEMS. THE PERFORMANCE OF THE HBC IGM QUALITY CONTROL MATERIAL HAS NOT BEENESTABLISHED WITH ANY OTHER ANTI-HBC IGM ASSAYS.
P970012|S040|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|12/24/2008|||APPR|APPROVAL FOR A CHANGE IN THE BARB FASTENER MANUFACTURING PROCESS.
P990001|S041|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|12/24/2008|||APPR|APPROVAL FOR A CHANGE IN THE BARB FASTENER MANUFACTURING PROCESS.
P010015|S050|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC & INSYNC III|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|12/24/2008|||APPR|APPROVAL FOR A CHANGE IN THE BARB FASTENER MANUFACTURING PROCESS.
N16837|S006|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|12/17/2008|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER.
P980035|S110|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL.  THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
P010031|S117|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC CRT-D/CONCERTO/CONSULTA/MAXIMO II & VARIOUS INSYNC FAMILIES OF ICDS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL.  THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
P010015|S051|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC PULSE GENERATOR; INSYNC III|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL.  THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
P990001|S042|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL.  THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
P980050|S036|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II AT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL.  THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
P980016|S148|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL.  THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
P970012|S041|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL.  THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
P900061|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM  & GEM II VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2008|09/10/2008|||OK30|ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL.  THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
P020026|S057|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2008|09/12/2008|||OK30|EXTENSION OF THE SHELF-LIFE OF A COMPONENT OF THE DEVICE.
P980022|S032|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice||N|08/12/2008|08/28/2008|||OK30|CHANGES TO THE GLUCOSE SENSOR¿S COATING PROCESS.
P980035|S111|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2008|09/11/2008|||OK30|CHANGES TO THE BATTERY BURN-IN PROCESS.
P970012|S042|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 SR|NVZ|CV|30-Day Notice||N|08/12/2008|09/11/2008|||OK30|CHANGES TO THE BATTERY BURN-IN PROCESS.
P970034|S011|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2008|09/12/2008|||OK30|CHANGES TO THE TUMBLING PROCESS.
P010027|S001|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2008|09/12/2008|||OK30|CHANGES TO THE TUMBLING PROCESS.
P980049|S040|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR 6250 AND OVATIO DR 6550|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2008|10/31/2008|||APPR|APPROVAL FOR A MODIFICATION TO THE AUTOMATIC SENSITIVITY CONTROL (ASC) ALGORITHM IN THE OVATIO VR 6250, OVATIO DR 6550 AND OVATIO CRT 6750.
P060027|S004|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT 6750|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2008|10/31/2008|||APPR|APPROVAL FOR A MODIFICATION TO THE AUTOMATIC SENSITIVITY CONTROL (ASC) ALGORITHM IN THE OVATIO VR 6250, OVATIO DR 6550 AND OVATIO CRT 6750.
P970034|S012|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2008|09/18/2008|||OK30|CHANGE IN BLOCKING WAX FORMULATION.
P010027|S002|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2008|09/18/2008|||OK30|CHANGE IN BLOCKING WAX FORMULATION.
P020056|S007|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|ALLERGAN SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2008|09/12/2008|||OK30|CHANGE IN THE SUPPLIER OF CERTAIN COMPONENTS OF THE DEVICE.
P030031|S011|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|NAVISTAR & CELSIUS THERMOCOOL CATHETERS|OAE|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|08/13/2008|02/06/2009|09M-0071|02/18/2009|APPR|APPROVAL FOR THE NAVISTAR THERMOCOOL CATHETER AND EZ STEER THERMOCOOL CATHETER-NAV VERSION. THESEDEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING ANDRECORDING), AND WHEN USED WITH THE STOCKERT 70 GENERATOR, FOR THE TREATMENT OF:1) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.2) RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA(VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS.3) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.
P070016|S002|WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 TAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/15/2008|11/25/2008|||APPR|APPROVAL FOR USE OF A MODIFIED INTRODUCTION SYSTEM, THE Z-TRAK PLUS INTRODUCTION SYSTEM, WITH THE ZENITH TX2 TAA ENDOVASCULAR GRAFT.
P960040|S175|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT SW AND LIVIAN SW|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2008|08/18/2009|||APPR|APPROVAL FOR THE PROGRAMMER SW MODEL 2888 V1.08 AND PROGRAMMER MODEL 2945 V1.02.
P010012|S191|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN SW|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2008|08/18/2009|||APPR|APPROVAL FOR THE PROGRAMMER SW MODEL 2888 V1.08 AND PROGRAMMER MODEL 2945 V1.02.
P970029|S012|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|SOLARGEN 2100S LASER|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/2008|09/11/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE SOLARGEN 2100S LASER USER MANUAL.
P020018|S029|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT RENU AAA ANCILLARY GRAFT|MIH|CV|135 Review Track For 30-Day Notice||N|08/15/2008|11/17/2008|||APPR|APPROVAL FOR AN ALTERNATE VENDOR FOR POLYESTER SUTURE.
P050007|S011|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2008|09/12/2008|||OK30|MODIFICATION TO THE STERILIZATION CYCLE FOR THE DEVICE.
P960043|S064|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|SUTURE MEDIATED CLOSURE (SMC) SYSTEMS|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2008|09/12/2008|||OK30|MODIFICATION TO THE STERILIZATION CYCLE FOR THE DEVICE.
P840001|S119|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2008|09/17/2008|||OK30|CHANGE TO QUALIFY A SECOND VENDOR.
P000029|S049|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2008|09/11/2008|||APPR|APPROVAL FOR A REVISED SPECIFICATION FOR THE PHOSPHATE BUFFER CONCENTRATE, INCLUDING THE TEST METHODS FOR PH DETERMINATION AND ENDOTOXIN DETERMINATION AS PART OF THE SPECIFICATION.
P070027|S003|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2008|05/21/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE CURRENT MANUFACTURING PROCESS USED BY THE SUPPLIER OF STENT COMPONENTS FOR THE DEVICE.
P070007|S003|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice||N|08/18/2008|05/21/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE CURRENT MANUFACTURING PROCESS USED BY THE SUPPLIER OF STENT COMPONENTS FOR THE DEVICE.
P020056|S008|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/18/2008|11/04/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020056|S009|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/18/2008|04/22/2009|||APPR|APPROVAL FOR LABELING THAT REFLECTS THE FOCUS GROUP STUDY FINDINGS AND 7-YEAR CORE STUDY DATA.
P980035|S112|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2008|09/17/2008|||OK30|REPLACEMENT OF EXISTING, OBSOLETE EPOXY DISPENSER WITH NEW EQUIPMENT.
P980022|S033|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CARELINK PERSONAL SOFTWARE|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/2008|09/24/2008|||APPR|APPROVAL  FOR A CHANGE TO THE CARELINK PERSONAL THERAPYMANAGEMENT SOFTWARE FOR DIABETES (MMT-7333) THE CARELINK PERSONAL THERAPY MANAGEMENTSOFTWARE FOR DIABETES IS A NETWORK BASED SOFTWARE SYSTEM RESIDING ON A COMPUTER SERVER PLATFORM CONNECTED TO THE INTERNET. THE PURPOSE OF THIS SYSTEM IS TO TAKE INFORMATION TRANSMITTED FROM INSULIN PUMPS, CONTINUOUS GLUCOSE MONITORS AND GLUCOSE METERS, AND LOGBOOK DATA ENTERED BY THE PATIENT, AND TURN IT INTO MEDTRONIC CARELINK THERAPY MANAGEMENT SOFTWARE FOR DIABETES REPORTS.THE REPORTS PROVIDE INFORMATION THAT CAN BE USED TO IDENTIFY TRENDS AND TRACK DAILY ACTIVITIES; SUCH AS CARBOHYDRATES EATEN, MEAL TIME, INSULIN DELIVERY, AND BLOOD GLUCOSE READINGS. THE SOFTWAREVERSION 4.6 IS A REVISION TO IMPLEMENT SEVERAL FEATURE ENHANCEMENTS, WHICH INCLUDE A LOGBOOKDIARY REPORT, REMOVAL OF ROCHE ACCU-CHECK 'AVIVA' AND COMPACT PLUS METERS FROM METERLISTINGS DISPLAYED FOR USERS LOCATED IN COUNTRIES OTHER THAN U.S. AND CANADA, AND CONSOLIDATION OF THE HELP SYSTEM THAT SERVES AS INSTRUCTIONS FOR USE.
P010031|S118|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/MAXIMO II/CONSULTA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2008|09/17/2008|||OK30|REPLACEMENT OF EXISTING, OBSOLETE EPOXY DISPENSER WITH NEW EQUIPMENT.
P990001|S043|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2008|09/17/2008|||OK30|REPLACEMENT OF EXISTING, OBSOLETE EPOXY DISPENSER WITH NEW EQUIPMENT.
P980016|S149|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2008|09/17/2008|||OK30|REPLACEMENT OF EXISTING, OBSOLETE EPOXY DISPENSER WITH NEW EQUIPMENT.
P050047|S005|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/2008|01/07/2010|||APPR|APPROVAL FOR THE ADDITION OF 0.3% LIDOCAINE INTO JUVEDERM ULTRA AND JUVEDERM ULTRA PLUS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
P030054|S103|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF / ATLAS + FAMILY OF CRT-DS|NIK|CV|Real-Time Process||N|08/19/2008|09/04/2008|||APPR|APPROVAL FOR AN ALTERNATE HIGH VOLTAGE CHARGING TRANSFORMER AND ASSOCIATED MINOR DESIGN CHANGES TO THE HVPCB FOR THE CURRENT AND PROMOTE ICDS/CRT-DS.
P910023|S188|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process||N|08/19/2008|09/04/2008|||APPR|APPROVAL FOR AN ALTERNATE HIGH VOLTAGE CHARGING TRANSFORMER AND ASSOCIATED MINOR DESIGN CHANGES TO THE HVPCB FOR THE CURRENT AND PROMOTE ICDS/CRT-DS.
P020045|S025|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER/ FREEZOR XTRA & MAX SURGICAL CRYOABLATION & CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2008|11/14/2008|||APPR|APPROVAL FOR CHANGING THE MANUFACTURING PROCESS OF ELECTRICAL CABLE SUBASSEMBLY.
P990074|S019|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|ALLERGAN SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2008|09/19/2008|||OK30|CHANGE IN THE SUPPLIERS OF CERTAIN COMPONENTS OF THE DEVICE.
P040023|S011|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2008|03/04/2009|||APPR|APPROVAL OF A CHANGE TO THE DESIGN SPECIFICATION OF A FORGING COMPONENT FOR THE SUMMIT HIP FEMORAL PROSTHESIS.
P900023|S050|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED ARTERIAL CANNULA|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2008|09/18/2008|||OK30|CHANGE FROM A COATING PROCEDURE PERFORMED AT AN OUTSIDE VENDOR TO A COATING PROCEDURE PERFORMED AT ABIOMED.
P000006|S011|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2008|09/16/2008|||APPR|APPROVAL FOR CHANGES TO THE ¿SHELF LIFE PROGRAM FOR THE TITAN INFLATABLE PENILE PROSTHESIS ¿ 60 DEGREES C ACCELERATED AND REAL TIME AGING¿ (I.E., SHELF LIFE TESTING PROTOCOL; DOCUMENT ¿MUS 085:065¿), UPDATED TO INCORPORATE THE TEST PARAMETERS FOR THE ONE-TOUCH RELEASE (OTR) PUMP.
P880031|S015|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|VITRAX/HEALON D SODIUM HYALURONATE SOLUTION OPHTHALMIC VISCOSURGICAL DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2008|09/19/2008|||OK30|IMPLEMENTATION OF A NEW WATER SYSTEM.
P810031|S036|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON, HEALON GV/HEALON 5 SODIUM HYALURONATE OPHTHALMIC VISCOSURGICAL DEVICES|LZP|OP|30-Day Notice||N|08/20/2008|09/19/2008|||OK30|IMPLEMENTATION OF A NEW WATER SYSTEM.
P050017|S004|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2008|07/23/2009|||APPR|APPROVAL FOR A MODIFICATION FROM THE EXISTING OVER-THE-WIRE DELIVERY SYSTEM TO A RAPID EXCHANGE DELIVERY SYSTEM FOR THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.  PATIENTS MUST BE SUITABLE FOR PTA AND STENT TREATMENT.
P040043|S024|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/20/2008|11/07/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE DISTAL END OF THE DELIVERY SYSTEM WHERE THE ENDOGRAFT IS CONSTRAINED AND CHANGES TO THE DELIVERY CATHETER HUB, AND IS INDICATED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY.
P980016|S150|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR/VR 7274/7230 ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/20/2008|10/24/2008|||APPR|APPROVAL FOR THE RV LEAD INTEGRITY ALERT (RVLIA) FEATURE AND MODEL SW012, VERSION 1.1, RVLIA SOFTWARE.
P970021|S023|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2008|09/19/2008|||OK30|USE OF AN ADDITIONAL STERILIZATION CHAMBER, WHICH IS LOCATED IN THE CURRENTLY APPROVED MANUFACTURING FACILITY.
P070015|S005|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2008|09/09/2008|||OK30|CHANGE FROM A MANUAL COILING PROCESS TO AN AUTOMATED COILING PROCESS IN THE MANUFACTURE OF THE EECSS.
P980049|S041|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR 6250 & DR 6550|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/21/2008|02/03/2009|||APPR|APPROVAL FOR THE IGBT (PART NUMBER 10N170) TO BE USED IN THE SHOCK 6 HYBRID MODULE T273 (SCOT273) FOR THE OVATIO ICD AND CRT DEVICES.
P060027|S005|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT 6750|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/21/2008|02/03/2009|||APPR|APPROVAL FOR THE IGBT (PART NUMBER 10N170) TO BE USED IN THE SHOCK 6 HYBRID MODULE T273 (SCOT273) FOR THE OVATIO ICD AND CRT DEVICES.
P000037|S014|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2008|10/09/2008|||OK30|INTRODUCTION OF A SECOND D-OX CLEANING PROCESS.
P050007|S012|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2008|09/19/2008|||OK30|CHANGE TO AUTOMATE A CURRENTLY MANUAL PROCESS.
P030036|S009|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2008|02/25/2009|||APPR|APPROVAL FOR THE FOLLOWING CHANGES: 1) A CHANGE IN THE MANUFACTURING FACILITY FOR THE DRUG VIAL FILLING PROCESS; 2) THE ADDITION OF A CONTRACT LABORATORY FOR DRUG RELEASE TESTING; AND 3) A CHANGE IN A QUALITY CONTROL TEST USED TO DETERMINE A SPECIFIC ATTRIBUTE OF AN INCOMING RAW MATERIAL.
P990052|S020|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM|MPV|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2008|01/09/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROSE GMBH, TRIER, GERMANY TO PERFORM STERILIZATION ACTIVITIES.
P960004|S041|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROX EZ LEADS|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2008|10/09/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE MANNITOL BULLET FORMING FIXTURE AND LEAD TIP PROTECTOR FOR THE DEVICE.
P030056|S002|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR HCV ON CENTAUR CP|MZO|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/25/2008|08/13/2009|||APPR|APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HCV ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP.ADVIA CENTAUR HCV READYPACK REAGENTS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR HCV ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEDETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THEDIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS CINFECTION.ADVIA CENTAUR HCV QUALITY CONTROLS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR HCV QUALITY CONTROLS ARE INTENDED FOR IN VITRO DIAGNOSTIC USE INMONITORING THE PERFORMANCE OF THE HCV ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HCV QUALITY CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HCV ASSAY.
P010019|S011|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|AIR OPTIX FOR ASTIGMATISM|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/25/2008|01/16/2009|||APPR|APPROVAL FOR A CHANGE IN TRADE NAME.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AIR OPTIX FOR ASTIGMATISM (LOTRAFILCON B) SOFT CONTACT LENSES.
P960030|S023|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|SJM ISOFLEX OPTIM LEADS|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2008|10/09/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, LLC, ARECIBO, PUERTO RICO.
P040004|S002|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/26/2008|10/20/2009|||APPR|APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HBC TOTAL ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBC TOTAL ASSAY AND IS INDICATED FOR:ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION OF TOTAL ANTIBODIES TO THE CORE ANTIGEN OF THE HEPATITIS B VIRUS (HBC TOTAL)IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OFINDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND IN THE DETERMINATION OF THE CLINICAL STATUS OF HBV INFECTED INDIVIDUALS IN CONJUNCTION WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. THIS ASSAY CAN ALSO BE USED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS ININDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.  ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS ON THE CENTAUR CP ANALYZER:FOR MONITORING THE PERFORMANCE OF THE HBC TOTAL ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBC TOTAL QUALITY CONTROL MATERIAL HAS NOT BEENESTABLISHED WITH ANY OTHER ANTI-HBC TOTAL ASSAYS.
P900056|S094|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGABLE CATHETER|MCX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2008|01/14/2009|||APPR|APPROVAL FOR A LABELING CHANGE TO THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ¿ ROTALINK EXCHANGEABLE CATHETER, WHICH REVISES THE RECOMMENDED OPTIMAL ROTATIONAL SPEED RANGE FOR THE SYSTEM.
P820003|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 5388 & 5348 EXTERNAL PULSE GENERATOR|LWP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2008|10/17/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA.
P030025|S058|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 OTW PACLITAXEL ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2008|09/26/2008|||OK30|CHANGE TO THE METHOD THAT IS USED TO CREATE THE PROXIMAL MARKS, THREE WHITE CIRCUMFERENTIAL MARKINGS, LOCATED ON THE SHAFT OF THE CATHETER.
P020009|S046|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2008|09/26/2008|||OK30|CHANGE TO THE METHOD THAT IS USED TO CREATE THE PROXIMAL MARKS, THREE WHITE CIRCUMFERENTIAL MARKINGS, LOCATED ON THE SHAFT OF THE CATHETER.
P040016|S033|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2008|09/26/2008|||OK30|CHANGE TO THE METHOD THAT IS USED TO CREATE THE PROXIMAL MARKS, THREE WHITE CIRCUMFERENTIAL MARKINGS, LOCATED ON THE SHAFT OF THE CATHETER.
P860019|S228|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK OTW PTCA CATHETER AND QUANTUM MAVERICK OTW PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2008|09/26/2008|||OK30|CHANGE TO THE METHOD THAT IS USED TO CREATE THE PROXIMAL MARKS, THREE WHITE CIRCUMFERENTIAL MARKINGS, LOCATED ON THE SHAFT OF THE CATHETER.
P890003|S148|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2008|10/14/2008|||APPR|APPROVAL FOR AN UPDATE (VERSION 1.1) TO SOFTWARE APPLICATION MODEL SW007 FOR THE MEDTRONIC CARELINK PROGRAMMER MODEL 2090.
P070013|S003|COLBAR LIFESCIENCE LTD.|9 HAMENOFIM ST.||HERZLIYA||46733||Implant, dermal, for aesthetic use|EVOLENCE COLLAGEN FILLER|LMH|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/2008|06/05/2009|||APPR|APPROVAL FOR LABELING CHANGES BASED ON THE ADDITIONAL CLINICAL 12 MONTH SAFETY AND EFFICACY DATA SUBMITTED TO EXTEND THE INITIAL 6 MONTH SAFETY AND EFFICACY DATA.
P960040|S176|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY AND VITALITY 2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2008|09/26/2008|||OK30|ADDITION OF AN ALTERNATIVE ADHESIVE FOR THE DIGITAL APPLICATION-SPECIFIC INTEGRATED CIRCUIT (ASIC).
P030005|S054|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2008|09/26/2008|||OK30|ADDITION OF AN ALTERNATIVE ADHESIVE FOR THE DIGITAL APPLICATION-SPECIFIC INTEGRATED CIRCUIT (ASIC).
P980022|S034|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CARELINK PRO PC SOFTWARE|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/2008|11/24/2008|||APPR|APPROVAL FOR AN UPDATE OF SOFTWARE USED IN THE CARELINK PRO, MODEL MMT-7335 TO VERSION 1.2A.
P030039|S011|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/2008|09/26/2008|||APPR|APPROVAL FOR ADDITION OF SAFETY RELATED STATEMENTS TO THE LABELING.
P060002|S003|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/2008|09/23/2008|||APPR|APPROVAL TO ADD A SPECIFICATION AND INSPECTION PROCEDURE TOR THE Y-INJECTION-ADAPTER COMPONENT.
P000058|S029|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT / LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2008|11/24/2008|||APPR|APPROVAL FOR ADDITIONAL TREATMENT PROCESSING VESSELS, UPGRADES TO PROCESS EQUIPMENT AND AUTOMATION OF A TEST METHOD.
P000054|S018|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2008|11/24/2008|||APPR|APPROVAL FOR ADDITIONAL TREATMENT PROCESSING VESSELS, UPGRADES TO PROCESS EQUIPMENT AND AUTOMATION OF A TEST METHOD.
P050053|S009|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2008|11/24/2008|||APPR|APPROVAL FOR ADDITIONAL TREATMENT PROCESSING VESSELS, UPGRADES TO PROCESS EQUIPMENT AND AUTOMATION OF A TEST METHOD.
P050038|S008|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2008|09/26/2008|||OK30|CHANGE FROM A MANUAL METHOD FOR ASSEMBLING THE DEVICE TO AN AUTOMATED METHOD.
P980040|S025|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2008|09/30/2008|||OK30|CHANGE IN THE SHEET CASTING PROCESS FOR MANUFACTURING THE DEVICE.
P960028|S030|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL ACRYLIC IOL|MFK|OP|30-Day Notice||N|08/29/2008|09/30/2008|||OK30|CHANGE IN THE SHEET CASTING PROCESS FOR MANUFACTURING THE DEVICE.
P990080|S031|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC IOL|HQL|OP|30-Day Notice||N|08/29/2008|09/30/2008|||OK30|CHANGE IN THE SHEET CASTING PROCESS FOR MANUFACTURING THE DEVICE.
P040052|S007|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|MONOPREP PAP TEST|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2008|10/01/2008|||OK30|CHANGE OF VENDOR TO PHARMCO-AAPER FOR THE ALCOHOL-BASED SPECIMEN TRANSPORT SOLUTION (MPPT-STS) THAT PRESERVES SPECIMEN CELLULAR MORPHOLOGY AND INHIBITS MICROBIAL GROWTH.
P860004|S101|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II INFUSION SYSTEM||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2008|09/30/2008|||OK30|CHANGE OF A MANUAL PROCESS TO AN AUTOMATED PROCESS, AND A CHANGE OF MANUFACTURING EQUIPMENT WHERE THE SPECIFICATIONS OF THE EQUIPMENT ARE UNCHANGED.
P990074|S020|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2008|10/24/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT THE GLOBAL PARK FACILITY, LA AURORA DE HEREDIA, COSTA RICA, FOR THE SHELL DIPPING/FABRICATION PROCESS.
P870078|S006|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHETIC VALVED CONDUIT AND HANCOCK TROCAR BLADES AND HANDLE|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/2008|03/25/2009|||APPR|APPROVAL FOR THE ADDITION OF THE HANCOCK PORCINE BIOPROSTHETIC VALVED CONDUIT AND HANCOCK TROCAR BLADES AND HANDLE.
P060037|S004|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LPS-FLEX MOBILE|NJL|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/02/2008|11/06/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880086|S168|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2008|10/01/2008|||OK30|ADDITION OF AN END OF LIFE (EL) COMMUNICATION SOFTWARE TEST TO THE AUTOMATED MANUFACTURING SOFTWARE TEST SUITE USED DURING HYBRID MANUFACTURING.
P030035|S047|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2008|10/01/2008|||OK30|ADDITION OF AN END OF LIFE (EL) COMMUNICATION SOFTWARE TEST TO THE AUTOMATED MANUFACTURING SOFTWARE TEST SUITE USED DURING HYBRID MANUFACTURING.
P990056|S009|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2008|09/17/2008|||OK30|CHANGE IN THE QUALITY CONTROL TESTING METHOD USED TO DETERMINE THE BIOTIN BINDING CAPACITY OF THE ELECSYS MICROPARTICLES (BEADS).
P000027|S007|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2008|09/17/2008|||OK30|CHANGE IN THE QUALITY CONTROL TESTING METHOD USED TO DETERMINE THE BIOTIN BINDING CAPACITY OF THE ELECSYS MICROPARTICLES (BEADS).
P990012|S007|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2008|09/23/2008|||OK30|CHANGE IN THE QUALITY CONTROL TESTING METHOD USED TO DETERMINE THE BIOTIN BINDING CAPACITY OF THE ELECSYS MICROPARTICLE BEADS USED IN THE TWO ASSAYS.
P010054|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2008|09/23/2008|||OK30|CHANGE IN THE QUALITY CONTROL TESTING METHOD USED TO DETERMINE THE BIOTIN BINDING CAPACITY OF THE ELECSYS MICROPARTICLE BEADS USED IN THE TWO ASSAYS.
P990004|S015|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2008|10/03/2008|||OK30|ELIMINATION OF STERILITY TESTING AS PART OF THE STERILITY RELEASE PROCEDURE.  THE RESULTS OF BIOBURDEN TESTING AND DRY HEAT STERILIZATION PROCESS PARAMETERS WILL CONTINUE TO BE REVIEWED AS PART OF THE STERILITY RELEASE.
P000037|S015|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2008|10/03/2008|||OK30|REVISION TO THE SOFTWARE USED TO POST-PROCESS DIMENSIONAL MEASUREMENT INFORMATION.
P990027|S011|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/03/2008|05/01/2009|||APPR|APPROVAL FOR THE DYNAMIC ROTATIONAL EYE TRACKER WITH IRIS RECOGNITION FOR USE WITH THE BAUSCH & LOMB TECHNOLAS  217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISIONCORRECTION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECHNOLAS 217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISION CORRECTION AND IS INDICATED FOR:1) WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR THE REDUCTION ORELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO -3.00 D AND MRSE < = 7.50 D ATTHE SPECTACLE PLANE:REDUCTION OR ELIMINATION OF MYOPIA (NEARSIGHTEDNESS) FROM -1.00 D TO -7.00 D WITH LESS THAN -3.00 D ASTIGMATISM;2) REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -12.00 D MRSE, WITH SPHERE BETWEEN > -7.00 D TO -10.99 D AND CYLINDER BETWEEN 0.00 AND < -3.00 D; AND 4) REDUCTION OR ELIMINATION OF LOW-TO-MODERATE NATURALLY OCCURRING HYPEROPIA UP TO +4.00 D MRSE, WITH SPHERE BETWEEN +1.00 D TO +4.00 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO+2.00 D AT THE SPECTACLE PLANE.
P020004|S037|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2008|10/03/2008|||OK30|ADDITION OF AN AUTOMATED FILM WRAPPING MACHINE FOR THE EXCLUDER WRAPPED GRAFTS AND CUFFS AND TAG WRAPPED CUFF.
P040043|S025|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2008|10/03/2008|||OK30|ADDITION OF AN AUTOMATED FILM WRAPPING MACHINE FOR THE EXCLUDER WRAPPED GRAFTS AND CUFFS AND TAG WRAPPED CUFF.
P030017|S069|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2008|02/20/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE IMPLANTABLE PULSE GENERATOR (IPG) TEST PROCEDURE TO INCLUDE THE ADDITION OF A NEW PIECE OF EQUIPMENT.
P030017|S071|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/2008|06/01/2010|||APPR|APPROVAL FOR ADDING AN UNDERCUT ON THE FEEDTHROUGH WHERE THE HEADER ATTACHES.
P040008|S001|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA (TPSA) ASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2008|09/25/2008|||OK30|CHANGE OF VENDOR FOR THE MOUSE MONOCLONAL ANTIBODY USED IN THE MANUFACTURE OF THE DEVICE.
P910023|S189|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2008|12/18/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, LLC, ARECIBO, PUERTO RICO.
P030054|S104|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS II HF, ATLAS+ HF, ATLAS II+ HF, EPIC HF, EPIC II HF, EPIC+ HF, EPIC II+ HF, PROMOTE|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2008|12/18/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, LLC, ARECIBO, PUERTO RICO.
P040014|S008|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION CATHETERS|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2008|06/17/2009|||APPR|APPROVAL FOR SOFTWARE CHANGES IN THE IBI 1500T9 RF GENERATOR WITH SOFTWARE VERSION 1.42.
P040042|S013|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2008|06/17/2009|||APPR|APPROVAL FOR SOFTWARE CHANGES IN THE IBI 1500T9 RF GENERATOR WITH SOFTWARE VERSION 1.42.
P950020|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CORONARY FLEXTOME CUTTING BALLOON DEVICE|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|10/01/2008|||OK30|ADDITION OF A STEP TO AN EXISTING IN-PROCESS INSPECTION OF THE PROXIMAL BALLOON BOND FOR ALL MODELS OF THE DEVICE.
P070016|S003|WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 TAA ENDOVASCULAR GRAFT|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|01/27/2009|||APPR|APPROVAL FOR THE ADDITION OF A COMPONENT MANUFACTURER.
P880003|S095|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|DURA STAR RX PTCA BALLOON DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|09/30/2008|||OK30|CHANGES TO THE MANUFACTURING PROCESS TO ADDRESS THE POTENTIAL FOR SLOW OR NO DEFLATION OF THE DEVICE.
P030017|S072|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|09/30/2008|||OK30|CHANGE TO THE WELDING PROCESS FOR THE SPRING CONTACTS.
P030017|S073|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|09/30/2008|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED SCSII REMOTE CONTROL FUNCTIONAL TESTING PROCESS.
P030017|S074|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|02/25/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE IPG ASSEMBLY PROCESS.
P010030|S011|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR (MODELS 4000)|MVK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/05/2008|08/17/2009|||APPR|APPROVAL FOR THE NEXT GENERATION OF WEARABLE DEFIBRILLATORS DESIGNED TO BE SMALLER, LIGHTER, AND MORE USER-FRIENDLY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P030017|S075|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|04/03/2009|||APPR|APPROVAL FOR THE MODIFICATION TO THE LEAD HIPOT TEST.
P030017|S076|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|03/16/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE LINEAR LEAD ASSEMBLY PROCESS.
P030017|S077|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|09/30/2008|||OK30|CHANGE TO ADD SOLDER TO THE DIGITAL SHIELD OF THE EXTERNAL TRIAL STIMULATOR.
P030017|S079|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|09/30/2008|||OK30|CHANGES TO THE CONNECTOR STACK ASSEMBLY PROCESS.
P030017|S080|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|10/03/2008|||OK30|MODIFICATION TO THE IMPLANTABLE PULSE GENERATOR (IPG) VIBRATION TEST PROCESS.
P950037|S063|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CYLOS/PROTOS/AXIOS/PHILOS II & PHILOS/PHILOS DR-T PULSE GENERATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|12/31/2008|||OK30|CHANGE IN THE COMPONENT SUPPLIER FOR THE BATTERY CATHODE.
P070008|S006|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV (T) PULSE GENERATOR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|12/31/2008|||OK30|CHANGE IN THE COMPONENT SUPPLIER FOR THE BATTERY CATHODE.
P000053|S019|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|10/09/2008|||OK30|ADDITIONAL STERILIZATION UNIT AT THE FACILITY.
P010020|S011|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2008|10/09/2008|||OK30|ADDITIONAL STERILIZATION UNIT AT THE FACILITY.
P040002|S021|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOLOGIX POWERLINK SYSTEM, VISIFLEX IS DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2008|10/14/2008|||APPR|APPROVAL FOR MINOR DESIGN AND ASSOCIATED LABELING CHANGES TO THE VISIFLEX IS DELIVERY SYSTEM, A COMPONENT OF THE ENDOLOGIX POWERLINK SYSTEM.
P980035|S114|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2008|02/04/2009|||APPR|APPROVAL TO CHANGE THE PRODUCTION TEST LIMITS FOR THE SIN2 SENSE DETECT THRESHOLD IN THE NON-PACING MODE.
P980016|S152|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2008|10/02/2008|||OK30|CHANGE TO AUTOMATE A MANUFACTURING TEST FOR THE DEVICES.
P010031|S120|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC FAMILIES OF ICDS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2008|10/02/2008|||OK30|CHANGE TO AUTOMATE A MANUFACTURING TEST FOR THE DEVICES.
P910073|S074|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EASYTRAK 3|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2008|10/24/2008|||OK30|CHANGE IN THE MEDICAL ADHESIVE USED IN THE LEAD ADAPTER.
P050023|S016|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIOMESSENGER  II-S AND CARDIOMESSENGER II-S TLINE HOME MONITORING DEVICES|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/10/2008|12/11/2008|||APPR|APPROVAL FOR THE CARDIOMESSENGER II-S AND CARDIOMESSENGER II-S TLINE HOME MONITORING DEVICES FOR USE WITH BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P030054|S105|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKFLEX FAMILY OF LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2008|10/10/2008|||OK30|ALTERNATE SUPPLIER OF WELD ELECTRODES.
P020014|S021|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/2008|11/07/2008|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE ESSURE SYSTEM, I.E., DIMENSIONAL SPECIFICATION OF THE DELIVERY WIRE HOLDER; CHANGE TO THE RELEASE BAND POSITIONING; AND A CHANGE TO THE HEAT SHRINK TUBING LENGTH.
P000025|S037|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2008|10/09/2008|||APPR|APPROVAL FOR ADDING INSPECTIONS FOR SHORT CIRCUITS IN THE MANUFACTURING OF THE SONATA AND PULSAR IMPLANTS.
P990009|S023|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2008|10/16/2008|||OK30|CONSTRUCTION OF AN ADDITIONAL MANUFACTURING SUITE.
P070027|S004|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2008|03/23/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO EG, EMPALME, MEXICO
P950015|S011|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|THE HEART LASER CO2 TMR SYSTEM|MNO|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|09/12/2008|03/08/2009|||APPR|APPROVAL FOR CHANGES MADE TO THE LABELING AS A RESULT OF COMPLETION OF THE POST-APPROVAL STUDY.
P910073|S075|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|RELIANCE FAMILY ACTIVE FIXATION TACHY LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/2008|11/07/2008|||APPR|APPROVAL FOR A LUMEN SEAL MODIFICATION ON ENDOTAK RELIANCE, RELIANCE S, RELIANCE G, AND RELIANCE SG LEAD FAMILIES.
P070007|S004|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2008|03/23/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO EG, EMPALME, MEXICO
P920047|S038|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|STEEROCATH T CARDIAC ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|10/10/2008|||OK30|CHANGE TO THE PACKAGING PROCESS FOR THE DEVICE.
P050028|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2008|11/12/2008|||APPR|APPROVAL FOR THE SHELF LIFE EXTENSION OF THE TAQMAN HBV TEST COMPONENTS/KITS IN THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM.
P070015|S006|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|10/10/2008|||OK30|MODIFICATION TO THE ENVIRONMENTAL MONITORING (EM) ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING.
P030017|S081|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|03/06/2009|||APPR|APPROVAL FOR IMPROVEMENTS IN THE IMPLANTABLE PULSE GENERATOR (IPG) ASSEMBLY PROCESS.
P030017|S082|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2008|06/01/2010|||APPR|APPROVAL FOR SUBSTITUTING A NEW TYPE OF POLYMIDE TAPE.
P030017|S083|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM (SCS)|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|04/02/2009|||APPR|APPROVAL FOR THE MODIFICATION TO THE CONTACT WELDING FOR THE LEAD EXTENSION.
P030017|S084|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2008|06/01/2010|||APPR|APPROVAL FOR THE USE OF PETG, A NEW TYPE OF BATTERY INSULATION MATERIAL.
P030017|S085|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|05/01/2009|||APPR|APPROVAL FOR A MODIFICATION TO PROCESSING EQUIPMENT AT A CONTRACT VENDOR.
P030017|S086|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|10/15/2008|||OK30|CHANGES TO THE IMPLANTABLE PULSE GENERATOR ASSEMBLY PROCESS.
P030017|S087|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|10/14/2008|||OK30|CHANGE TO THE EPOXY MIXING PROCESS.
P010030|S012|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2008|11/14/2008|||APPR|APPROVAL FOR TWO NEW LITHIUM ION CELLS THAT ARE USED TO CONSTRUCT THE WCD 3000 BATTERY PACK.
P950029|S038|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY SR/DR & RHAPSODY SR/DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|10/17/2008|||OK30|CHANGE THE WELDING ENERGY MEASUREMENT METHOD FROM AN INDIRECT METHOD TO A DIRECT ENERGY MEASUREMENT METHOD.
P980049|S042|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|10/17/2008|||OK30|CHANGE THE WELDING ENERGY MEASUREMENT METHOD FROM AN INDIRECT METHOD TO A DIRECT ENERGY MEASUREMENT METHOD.
P060027|S006|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2008|10/17/2008|||OK30|CHANGE THE WELDING ENERGY MEASUREMENT METHOD FROM AN INDIRECT METHOD TO A DIRECT ENERGY MEASUREMENT METHOD.
P030022|S010|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|09/10/2008|03/06/2009|||APPR|APPROVAL FOR THE REVISIONS TO THE PRODUCT LABEL.
P970004|S062|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2008|01/30/2009|||APPR|APPROVAL FOR PHYSICIAN-SUGGESTED SOFTWARE MODIFICATIONS AND ASSOCIATED LABELING MODIFICATIONS.
P010003|S013|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/2008|05/01/2009|||APPR|APPROVAL FOR CHANGES TO THE LABELING.
P970037|S002|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA HAFP KIT|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/17/2008|04/08/2009|||APPR|APPROVAL FOR A CHANGE IN THE PRODUCTION SITE OR THE TWO ANTIBODIES USED IN THE AUTODELIA HAFP KIT TO WALLAC OY, TURK, FINLAND, AND FOR A CHANGE IN THE ANTIGEN SOURCE IN THE HAFP STANDARDS OF  THE AUTODELIA HAFP KIT.
P980022|S035|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2008|10/02/2008|||OK30|CHANGE TO THE STERILIZATION PROCESS OF THE GLUCOSE SENSOR'S ADHESION PATCH.
P910073|S076|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2008|10/17/2008|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE SHOCKING COIL COMPONENTS.
P010031|S121|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNCII/ III PROTECT/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/CONCERTO/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2008|10/10/2008|||OK30|CHANGE TO PERFORM WAFER SAW AND DIE VISUAL PROCESSING AT THE SUPPLIER.
P980016|S153|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2008|10/10/2008|||OK30|CHANGE TO PERFORM WAFER SAW AND DIE VISUAL PROCESSING AT THE SUPPLIER.
P990001|S044|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C-SERIES AND T-SERIES DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2008|10/10/2008|||OK30|CHANGE TO PERFORM WAFER SAW AND DIE VISUAL PROCESSING AT THE SUPPLIER.
P980035|S115|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2008|10/10/2008|||OK30|CHANGE TO PERFORM WAFER SAW AND DIE VISUAL PROCESSING AT THE SUPPLIER.
P030029|S004|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS (AHBS)|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/2008|06/10/2009|||APPR|APPROVAL FOR ADDING QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS BSURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA TO THE INTENDED USE.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR® AND ADVIACENTAUR® XP ANTI-HBS ASSAY AND IS INDICATED FOR:THE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEAND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAURAND ADVIA CENTAUR XP SYSTEMS. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATIONOF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBVVACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH I HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYINGSIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.
P000029|S050|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|05/21/2009|||APPR|APPROVAL FOR A CHANGE IN THE TESTING FACILITY USED DURING MANUFACTURING.
P980035|S116|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE IN EQUIPMENT USED FOR BLISTER SEALING PROCESS.
P970012|S044|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE IN EQUIPMENT USED FOR BLISTER SEALING PROCESS.
P980016|S154|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE IN EQUIPMENT USED FOR BLISTER SEALING PROCESS.
P990001|S045|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CLARITY, DIAMOND 3, JADE 3, RUBY 3, TOPAZ 3, VITA 2 DDR, C-SERIES, AND T-SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE IN EQUIPMENT USED FOR BLISTER SEALING PROCESS.
P010031|S122|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||VARIOUS FAMILIES OF CRT-ICDS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE IN EQUIPMENT USED FOR BLISTER SEALING PROCESS.
P010015|S053|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC & INSYNC III|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE IN EQUIPMENT USED FOR BLISTER SEALING PROCESS.
P040003|S005|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000 SYSTEM|NRZ|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/2008|03/04/2009|||APPR|APPROVAL FOR LABELING AND TREATMENT PROTOCOL CHANGES.  THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME EXABLATE 2000 AND IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE-OR PER-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE AND WHOSE UTERINE SIZE IS LESS THAN 24 WEEKS.  LIMITED INFORMATION IS AVAILABLE REGARDING THE SAFETY AND EFFECTIVENESS OF THE EXABLATE AS A TREATMENT FOR WOMEN WHO DESIRE PREGNANCY.  PATIENTS SHOULD HAVE COMPLETED CHILD BEARING.
P010031|S123|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONSULTA/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE THE LASER RIBBON BONDING MANUFACTURING PROCESS.
P980016|S155|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE THE LASER RIBBON BONDING MANUFACTURING PROCESS.
P980035|S117|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG& ADAPTA/VERSA/SENSIA FAMILY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2008|10/17/2008|||OK30|CHANGE THE LASER RIBBON BONDING MANUFACTURING PROCESS.
P060031|S001|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLOSA ANTI-HBC EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2008|10/09/2008|||OK30|ADDING A NEW FILLING MACHINE FOR USE IN THE MANUFACTURING OF THE POSITIVE AND NEGATIVE CONTROL VIALS AND THE CALIBRATOR VIAL IN THE KIT.
P060034|S001|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC IGM EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2008|10/09/2008|||OK30|ADDITION OF A NEW FILLING MACHINE FOR USE IN THE MANUFACTURING OF THE POSITIVE AND NEGATIVE CONTROL VIALS AND THE CALIBRATOR VIAL IN THE KIT.
P040024|S028|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2008|10/22/2008|||OK30|APPROVAL TO PERFORM A QUALITY CONTROL TEST IN-HOUSE THAT IS NOW BEING PERFORMED BY A CONTRACT LABORATORY.
P990009|S024|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL ENDOSCOPIC APPLICATOR|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2008|10/24/2008|||OK30|ADDITIONAL CLEANING PROCEDURE AND INSPECTION PROCEDURE AT TWO (2) CONTRACT VENDORS AND AN INSPECTION PROCEDURE AT THE BAXTER MANUFACTURING FACILITY LOCATED N IRVINE, CALIFORNIA.
P980016|S156|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2008|10/17/2008|||OK30|CHANGE IN THE ASSEMBLY FLOW AND THE ADDITION OF A NEW PIECE OF EQUIPMENT.
P010031|S124|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D & MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2008|10/17/2008|||OK30|CHANGE IN THE ASSEMBLY FLOW AND THE ADDITION OF A NEW PIECE OF EQUIPMENT.
P930014|S028|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF SINGLE-PIECE INTRAOCULAR LENSES (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2008|10/15/2008|||OK30|MOVING OF THE IOL FINAL PACKAGING AND SECONDARY LABELING OPERATIONS, WITH THREE (3) SUPPORT FUNCTIONS, INTO THE RECENTLY CONSTRUCTED NEW FACILITY ON THE SAME PROPERTY.
P900056|S095|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2008|02/17/2009|||APPR|APPROVAL FOR CHANGES TO THE TEST METHOD FOR THE DEVICE.
P050012|S017|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|THE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/2008|12/03/2008|||APPR|APPROVAL FOR MODIFICATIONS MADE TO THE RECEIVER SUB-COMPONENT PCBA AND HOUSING; MANUFACTURING PROCESSES OF THE RECEIVER TO ACCOMMODATE A REVISED PCBA; AND OUTSOURCING OF THE ALTERNATIVE RECEIVER MANUFACTURING PROCESS.
P040052|S008|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|MONOPREP PAP TEST|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2008|10/16/2008|||OK30|NEW SUPPLIER FOR THE MEMBRANE COMPONENT OF THE MPPT FILTER.
P000025|S038|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2008|10/24/2008|||OK30|ADDITION OF TWO CLEAN-ROOMS AT THE AUSTRIA FACILITY.
P990052|S021|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM|MPV|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2008|10/24/2008|||OK30|ADDITION OF TWO CLEAN-ROOMS AT THE AUSTRIA FACILITY.
N16895|S090|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFTLENS (POLYMACON) CONTACT LENS|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2008|11/03/2008|||APPR|APPROVAL FOR USING A NEW SUPPLIER OF POLYPROPYLENE RESIN FOR THE CONTACT LENS BLISTER PACKS.
P960022|S005|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS 66 AND SOFLENS TORIC (ALPHAFILCON) SOFT CONTACT LENS|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2008|11/03/2008|||APPR|APPROVAL FOR USING A NEW SUPPLIER OF POLYPROPYLENE RESIN FOR THE CONTACT LENS BLISTER PACKS.
P980006|S013|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION (BALAFILCON) VISIBILITY TINTED CONTACT LENSES|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2008|11/03/2008|||APPR|APPROVAL FOR USING A NEW SUPPLIER OF POLYPROPYLENE RESIN FOR THE CONTACT LENS BLISTER PACKS.
P010031|S125|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCENTRO II CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/24/2008|10/23/2008|||APPR|APPROVAL TO IMPLEMENT A DESIGN CHANGE TO ADD THREE NEW"INTERMEDIATE-FEATURE" MODELS (CONCERTO II MODEL CRT-D D274TRK. VIRTUOSO II ICD MODEL DRD274DRG AND MODEL VR D274VRC) TO THE APPROVED GEN 2 CONSULTA/SECURA/ MAXIMA II FAMILYOF DEVICES (CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK. SECURE VR D224VRC,MAXIMO II DR D284DRG, AND MAXIMO II D284 VRC SUBMITTED UNDER P01003I/S084 ANDP980016/S114, APPROVED MARCH 17, 2008).
P980016|S157|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II ICD DR/VR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/24/2008|10/23/2008|||APPR|APPROVAL TO IMPLEMENT A DESIGN CHANGE TO ADD THREE NEW"INTERMEDIATE-FEATURE" MODELS (CONCERTO II MODEL CRT-D D274TRK. VIRTUOSO II ICD MODEL DRD274DRG AND MODEL VR D274VRC) TO THE APPROVED GEN 2 CONSULTA/SECURA/ MAXIMA II FAMILYOF DEVICES (CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK. SECURE VR D224VRC,MAXIMO II DR D284DRG, AND MAXIMO II D284 VRC SUBMITTED UNDER P01003I/S084 ANDP980016/S114, APPROVED MARCH 17, 2008).
P820003|S086|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS TEMPORARY PACEMAKER MODELS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2008|03/09/2009|||APPR|APPROVAL FOR A CHANGE IN THE MODEL 5433 CABLE INSPECTION LEVEL.
P940015|S013|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2008|04/10/2009|||APPR|APPROVAL FOR THE RELOCATION OF MANUFACTURING PROCESSES WITHIN THE SAME FACILITY AND THE ADDITION OF AN ALTERNATE SYRINGE FILLING MACHINE.
P000009|S030|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LEXOS & LUMOS FAMILIES OF ICDS|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2008|03/12/2009|||APPR|APPROVAL FOR CHANGING THE ICD BATTERY PRE-DISCHARGING PROCESS.
P050023|S017|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILIES OF ICDS|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2008|03/12/2009|||APPR|APPROVAL FOR CHANGING THE ICD BATTERY PRE-DISCHARGING PROCESS.
P890003|S150|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR MODEL 2490C, MODEL 2491 DDMA AND CARDIOSIGHT READER MODEL 2020A|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2008|10/21/2008|||APPR|APPROVAL TO IMPLEMENT A DESIGN CHANGE TO USE MODELS 2490C MEDTRONIC CARELINK MONITOR, 2020A CARDIOSIGHT READER, AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO PROVIDE PATIENTS AND DATA TRANSFER FOR THE CONCERTO II MODEL CRT-D D274TRK, VIRTUOSO II ICD MODEL DR D274DRG AND MODEL VR D274VRC DEVICES.
P010031|S126|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II CRT-D MODELS C154DWK, C164AWK|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2008|10/21/2008|||APPR|APPROVAL TO IMPLEMENT A DESIGN CHANGE TO USE MODELS 2490C MEDTRONIC CARELINK MONITOR, 2020A CARDIOSIGHT READER, AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO PROVIDE PATIENTS AND DATA TRANSFER FOR THE CONCERTO II MODEL CRT-D D274TRK, VIRTUOSO II ICD MODEL DR D274DRG AND MODEL VR D274VRC DEVICES.
P980022|S036|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2008|10/03/2008|||OK30|CHANGE TO THE ONE-PIECE BASE NEEDLE TUNNEL GEOMETRY.
P980016|S158|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II ICD DR/VR MODELS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2008|10/21/2008|||APPR|APPROVAL TO IMPLEMENT A DESIGN CHANGE TO USE MODELS 2490C MEDTRONIC CARELINK MONITOR, 2020A CARDIOSIGHT READER, AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO PROVIDE PATIENTS AND DATA TRANSFER FOR THE CONCERTO II MODEL CRT-D D274TRK, VIRTUOSO II ICD MODEL DR D274DRG AND MODEL VR D274VRC DEVICES.
P990046|S019|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT BI-LEAFLET HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/26/2008|04/24/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P920048|S006|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|RAPID FFN FOR THE TLIIQ SYSTEM|LKV|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2008|10/22/2008|||OK30|ALTERNATIVE MANUFACTURING PROCESS FOR THE RAPID FFN CASSETTE.
P070009|S004|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND|LTI|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2008|02/23/2009|||APPR|APPROVAL TO MODIFY THE INJECTION PORT TORQUE INSPECTION PROCEDURE BY REPLACING PRE-AND POST-TORQUE TEST INSPECTIONS WITH VISUAL AND FUNCTIONAL INSPECTIONS AND MODIFY THREE INJECTION PORT MANUFACTURING DOCUMENTS TO INCORPORATE THE CHANGES IN THE TORQUE INSPECTION PROCEDURE AND TO IMPROVE CLARITY OF INSTRUCTIONS.
P950022|S054|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA & DURATA FAMILY OF LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2008|03/26/2009|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER.
P040024|S029|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2008|10/29/2008|||OK30|USE OF A RAW MATERIAL FROM A NEW PURIFICATION LINE AND A NEW STORAGE AREA.
P030025|S059|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2008|03/20/2009|||APPR|APPROVAL FOR CHANGES TO THE SIZE OF THE SIBS PIECES AND THE PROCESS FOR MIXING AND FILTERING THE SPRAY COATING SOLUTION USED TO MANUFACTURE THE DEVICE.
P050016|S004|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESUFACING SYSTEM|NXT|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/29/2008|11/04/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970003|S101|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2008|10/28/2008|||OK30|CHANGE TO THE HANDHELD REWORK PROCESS.
P050051|S003|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT AUSAB|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2008|11/13/2008|||APPR|APPROVAL FOR CHANGE OF GRAYZONE RANGE AND CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN.
P060037|S005|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN COMPLETE KNEE SOLUTION|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/2008|03/26/2009|||APPR|APPROVAL FOR CHANGES TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT,RESULTING IN THE NEXGEN MINIMALLY INVASIVE SOLUTIONS (MIS) LPS-MOBILE TIBIAL COMPONENT.CHANGES MADE TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT INCLUDE SHORTENING THETIBIAL BASEPLATE STEM AND ADDING BROAD PROXIMAL FINS, CHANGING THE OUTER PROFILE RADIUS OF THEBASEPLATE EDGE FROM A VARIABLE RADIUS TO A CONSTANT RADIUS, AND ADDING AN ADDITIONAL SIZE (4-PLUS)TO THE CURRENT RANGE OF SIZES (1 - 8).
P020036|S011|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2008|10/30/2008|||OK30|CHANGE TO THE TEST METHOD FOR A DELIVERY SYSTEM COMPONENT USED IN THE MANUFACTURE OF THE DEVICE.
P030047|S015|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2008|10/30/2008|||OK30|CHANGE TO THE TEST METHOD FOR A DELIVERY SYSTEM COMPONENT USED IN THE MANUFACTURE OF THE DEVICE.
P060034|S002|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC IGM EIA|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2008|02/20/2009|||APPR|APPROVAL FOR AN AMENDMENT TO THE PACKAGE INSERT WITH THE ADDITION OF THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED FOR THE DEVICE.
P950032|S049|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2008|12/10/2008|||APPR|APPROVAL FOR A NEW CELL STRAIN, HEP 014, FOR INTRODUCTION INTO PRODUCTION OF APLIGRAF.
P050048|S002|BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBS EIA|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2008|03/12/2010|||APPR|APPROVAL FOR THE MONOLISA ANTI-HBS EIA PACKAGE INSERT IN ORDER TO ADD THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, WITH UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED.
P830055|S106|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2008|11/23/2011|||APPR|APPROVAL TO MANUFACTURE THE SUBJECT COMPONENTS FROM GUR 1020 POLYETHYLENE WITH AN ANTIOXIDANT (AOX), TO CHANGE THE PACKAGING COMPONENTS AND MATERIALS, AND TO REQUEST APPROVAL OF A SHELF-LIFE TESTING PROTOCOL FOR THE SUBJECT P.F.C SIGMA RP CURVED AND STABILIZED TIBIAL INSERTS.
P070013|S005|COLBAR LIFESCIENCE LTD.|9 HAMENOFIM ST.||HERZLIYA||46733||Implant, dermal, for aesthetic use|EVOLENCE COLLAGEN FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2008|10/31/2008|||OK30|INCREASE PRODUCTION SCALE OF PURIFIED COLLAGEN DURING THE MANUFACTURING OF THE DEVICE.
P960058|S070|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2008|10/31/2008|||OK30|USE OF AN ALTERNATE COMPONENT FOR THE HIRES90K.
P970003|S102|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|NEUROCYBERNETIC PROSTHESIS (NCP) PROGRAMMING WAND|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2008|11/12/2008|||APPR|APPROVAL FOR LABELING CHANGES THAT INCLUDE THE ADDITION OF CONFIRMATORY TESTING INFORMATION, STRENGTHENING OF WARNINGS, AND FORMATTING REVISIONS.
P050037|S012|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2008|11/06/2008|||OK30|QUALIFICATION OF A MODIFIED PYROGEN TEST METHOD.
P050052|S013|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2008|11/06/2008|||OK30|QUALIFICATION OF A MODIFIED PYROGEN TEST METHOD.
P010012|S192|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL/LIVIAN|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2008|07/30/2009|||APPR|APPROVAL FOR THE REMOVAL OF A PRE-SCREENING INSPECTION.
P960040|S177|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT/VITALITY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2008|07/30/2009|||APPR|APPROVAL FOR THE REMOVAL OF A PRE-SCREENING INSPECTION.
P980016|S159|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2008|03/09/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID PRESS FIXTURE.
P010031|S127|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2008|03/09/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID PRESS FIXTURE.
P010041|S017|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2008|10/29/2008|||OK30|ALTERNATE SUPPLIER FOR GLUTERALDEHYDE USED IN THE MANUFACTURE OF TISSUE HEART VALVES.
P000007|S018|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2008|10/29/2008|||OK30|ALTERNATE SUPPLIER FOR GLUTERALDEHYDE USED IN THE MANUFACTURE OF TISSUE HEART VALVES.
P870077|S029|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2008|10/29/2008|||OK30|ALTERNATE SUPPLIER FOR GLUTERALDEHYDE USED IN THE MANUFACTURE OF TISSUE HEART VALVES.
P870056|S030|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS VALVED CONDUIT BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2008|10/29/2008|||OK30|ALTERNATE SUPPLIER FOR GLUTERALDEHYDE USED IN THE MANUFACTURE OF TISSUE HEART VALVES.
P860057|S050|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2008|10/29/2008|||OK30|ALTERNATE SUPPLIER FOR GLUTERALDEHYDE USED IN THE MANUFACTURE OF TISSUE HEART VALVES.
P000029|S051|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/2008|10/22/2008|||APPR|APPROVAL FOR MODIFICATION OF THE DEFLUX PACKAGE INSERT TO MINIMIZE THE INCIDENCE OF SYRINGE BREAKAGE AND RESULTING TREATMENT INTERRUPTIONS.
P040002|S022|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/2008|04/17/2009|||APPR|APPROVAL FOR THE 25MM AND 28MM SUPRARENAL CUFF ACCESSORIES FOR THE INFRARENAL VERSION OF THE POWERLINK BIFURCATED STENT GRAFT.
P980016|S160|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO/MARQUIS/INTRINSIC 30/INTRINSIC/ENTRUST|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2008|11/05/2008|||OK30|ADDITION OF AN IN-PROCESS LEAKAGE TEST.
P010031|S128|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC FAMILIES OF ICD & CONCERTO ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2008|11/05/2008|||OK30|ADDITION OF AN IN-PROCESS LEAKAGE TEST.
P840001|S121|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREULTRA IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2008|11/06/2008|||OK30|ADDITION OF A DUAL PIN PRESS TO THE MANUFACTURING PROCESS.
P840001|S122|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, RESTOREPRIME, RESTOREADVANCED, RESTORE PRIME ADVANCED, AND RESTOREULTRA NEUROSTIMULATION SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2008|12/08/2008|||APPR|APPROVAL FOR THE ADDITION OF A STABILIZING COIL TO THE MODEL 37083 EXTENSION, A ¿POST-CURE¿ PROCESSING STEP AT THE DISTAL END OF THE MODELS 37083 AND 37082 EXTENSIONS, AND A PROXIMAL BOND STRENGTH (THERMAL BOND) DESIGN REQUIREMENT FOR MODELS 37083 AND 37082 EXTENSIONS.
P020009|S047|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS MR & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2008|11/04/2008|||OK30|ALTERNATE METHOD FOR FINAL PACKAGING OF THE DEVICE INCLUDING LABEL DESIGN CHANGES UNDER THE BSC MASTER BRAND.
P860019|S229|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2008|11/04/2008|||OK30|ALTERNATE METHOD FOR FINAL PACKAGING OF THE DEVICE INCLUDING LABEL DESIGN CHANGES UNDER THE BSC MASTER BRAND.
P060033|S014|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|02/17/2009|||APPR|APPROVAL FOR AN EXTENSION OF THE IN-PROCESS SHELF-LIFE OF THE STENT COATING FORMULATIONS.
P990013|S024|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|01/14/2009|||OK30|ADDITION OF A SECOND WAX DISPENSING SYSTEM.
P030016|S011|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|01/14/2009|||OK30|ADDITION OF A SECOND WAX DISPENSING SYSTEM.
P840064|S036|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DUOVISC VISCOELASTIC SYSTEM & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|12/15/2008|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE AT STERIGENICS GERMANY GMBH IN GERMANY.
P890047|S024|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|12/15/2008|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE AT STERIGENICS GERMANY GMBH IN GERMANY.
P990025|S016|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|11/07/2008|||APPR|APPROVAL FOR TWO ADDITIONAL QUALITY CONTROL INSPECTION STEPS: 1) ADDING A 100% VISUAL INSPECTION OF THE PCB BOARDS TO VERIFY THAT ALL COMPONENTS ARE PRESENT, AND 2) ADDING AN EEPROM READ STEP DURING THE EXISTING CALIBRATION PROCESS TO VERIFY THAT ALL PCB COMPONENTS ARE PRESENT AND FUNCTIONING PROPERLY.
P010068|S013|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER|OAD|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|11/07/2008|||APPR|APPROVAL FOR TWO ADDITIONAL QUALITY CONTROL INSPECTION STEPS: 1) ADDING A 100% VISUAL INSPECTION OF THE PCB BOARDS TO VERIFY THAT ALL COMPONENTS ARE PRESENT, AND 2) ADDING AN EEPROM READ STEP DURING THE EXISTING CALIBRATION PROCESS TO VERIFY THAT ALL PCB COMPONENTS ARE PRESENT AND FUNCTIONING PROPERLY.
P030031|S012|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT CATHETER FAMILY|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|11/07/2008|||APPR|APPROVAL FOR TWO ADDITIONAL QUALITY CONTROL INSPECTION STEPS: 1) ADDING A 100% VISUAL INSPECTION OF THE PCB BOARDS TO VERIFY THAT ALL COMPONENTS ARE PRESENT, AND 2) ADDING AN EEPROM READ STEP DURING THE EXISTING CALIBRATION PROCESS TO VERIFY THAT ALL PCB COMPONENTS ARE PRESENT AND FUNCTIONING PROPERLY.
P040036|S009|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2008|11/07/2008|||APPR|APPROVAL FOR TWO ADDITIONAL QUALITY CONTROL INSPECTION STEPS: 1) ADDING A 100% VISUAL INSPECTION OF THE PCB BOARDS TO VERIFY THAT ALL COMPONENTS ARE PRESENT, AND 2) ADDING AN EEPROM READ STEP DURING THE EXISTING CALIBRATION PROCESS TO VERIFY THAT ALL PCB COMPONENTS ARE PRESENT AND FUNCTIONING PROPERLY.
P060037|S006|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE & LPS-MOBILE BEARING KNEE SYSTEMS|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2008|02/13/2009|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS FOR THE LPS FEMORAL COMPONENTS, AN ADDITIONAL CLEANING LINE, NEW GRINDING EQUIPMENT, AND AN ADDITIONAL INSPECTION STEP.
P020004|S038|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2008|11/26/2008|||OK30|CHANGE IN THE METHOD USED FOR COOLING THE ENDOPROSTHESIS PRIOR TO CRUSHING AND SUBSEQUENT LOADING ONTO THE DELIVERY DEVICE.
P980016|S161|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO DR/VR, MARQUIS DR/VR, INTRINSIC ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2008|11/07/2008|||OK30|ADDITION OF A CLEANING STEP.
P900007|S005|Cook Incorporated|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||CATHETER, SAMPLING, CHORIONIC VILLUS|COOK CHORIONIC VILLUS SAMPLING SET|LLX|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2008|04/02/2009|||APPR|APPROVAL FOR THE ADDITION OF ECHOTIP BANDING TO THE DISTAL TWO CENTIMETERS OF THE OBTURATOR.
P970008|S040|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIX SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2008|11/19/2008|||OK30|CHANGE OF AN ADHESIVE AND THE TEST METHOD  FOR MEASURING TENSILE STRENGTH.
P060033|S015|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2008|11/13/2008|||OK30|CHANGE IN VENDOR FOR MOLDED COMPONENTS USED IN THE MANUFACTURE OF THE DEVICE.
P030035|S048|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2008|11/13/2008|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR THE PARYLENE DIMER USED TO PARYLENE COAT PACEMAKERS AND CRT-PS
P880086|S169|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/IDENTITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2008|11/13/2008|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR THE PARYLENE DIMER USED TO PARYLENE COAT PACEMAKERS AND CRT-PS
P980016|S162|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2008|11/13/2008|||OK30|ALTERNATE VENDOR OF RAW MATERIAL USED IN FLEX CIRCUIT MANUFACTURE.
P010031|S129|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2008|11/13/2008|||OK30|ALTERNATE VENDOR OF RAW MATERIAL USED IN FLEX CIRCUIT MANUFACTURE.
P810002|S068|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL REGENT MECHANICAL HEART VALVE|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/14/2008|11/14/2008|||APPR|APPROVAL FOR MODIFICATIONS AND REARRANGEMENT OF THE INSTRUCTIONS FOR USE (IFU).
P030054|S106|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/15/2008|11/14/2008|||APPR|APPROVAL FOR THE HV CERAMIC RF MODULE FOR THE CURRENT RF ICDS AND PROMOTE RF CRT-DS.
P910023|S190|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/15/2008|11/14/2008|||APPR|APPROVAL FOR THE HV CERAMIC RF MODULE FOR THE CURRENT RF ICDS AND PROMOTE RF CRT-DS.
P050044|S006|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2008|11/14/2008|||OK30|INSTALLATION OF A SECOND MANUFACTURING LINE.
P060033|S016|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2008|11/13/2008|||OK30|EQUIPMENT MODIFICATION TO INCREASE THE CAPACITY AT AN IN-PROCESS WORK STEP.
P960040|S178|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY FAMILY OF ICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2008|11/14/2008|||APPR|APPROVAL FOR CHANGES TO THE VITALITY HE PROGRAMMER SOFTWARE MODEL 2896 VERSION 2.01, AFFECTING THE VITALITY HE FAMILY OF ICDS.
P040047|S009|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2008|11/14/2008|||OK30|ADDITION OF A NEW SUPPLIER FOR A COMPONENT USED IN THE PACKAGING OF THE DEVICE.
P050037|S013|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2008|11/14/2008|||OK30|NEW SUPPLIER FOR A PACKAGING COMPONENT FOR THE DEVICE.
P050052|S014|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2008|11/14/2008|||OK30|NEW SUPPLIER FOR A PACKAGING COMPONENT FOR THE DEVICE.
P950037|S064|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CYLOS DR-T PULSE GENERATOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|11/24/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE HEADER ASSEMBLY AND A CORRECTION TO THE TECHNICAL MANUAL.
P890003|S151|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PACEMAKERS, CARELINK PROGRAMMER MODEL 2090|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P950037|S065|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS II FAMILY OF PULSE GENERATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|11/06/2008|||APPR|APPROVAL FOR MODIFICATIONS TO THE INTEGRATED CIRCUITS, HEADER AND CAN OF THE PHILOS II FAMILY OF PULSE GENERATORS.
P820003|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS FAMILIES OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P850051|S069|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VARIOUS FAMILIES OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P900061|S079|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AND GEM FAMILIES OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P930022|S008|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P970012|S045|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P980016|S163|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM, ENTRUST, MARQUIS, MAXIMO, INTRINSIC AND VIRTUSO FAMILIES OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P980035|S118|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA, SIGMA, ENRHYTHM, ENPULSE, ADAPTA AND RELIA FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P980050|S037|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF, GEMIII AT FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P990001|S046|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VIATRON PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P010015|S055|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC PACEMAKER AND INSYNC III CRT-IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P010031|S130|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS FAMILIES OF CRT / ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/11/2008|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P020026|S058|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|SIROLIMUS-ELUTING STENT ON RAPTOR OTW DELIVERY SYSTEM & RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2008|12/08/2008|||OK30|CHANGE IN THE LOT RELEASE SAMPLING PLAN FOR THE MEASUREMENT OF STENT RETENTION FORCE.
P060033|S017|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2008|11/19/2008|||OK30|CHANGES TO THE ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM: 1) REUSE OF CATHETER HOOPS; 2) ELIMINATE PRE-PC SPRAY INSPECTION WORK STEP; 3) WELDING PROCESS AUTOMATION; 4) ALTERNATIVE POUCH SEALING EQUIPMENT; 5) CHANGE TO STENT STORAGE AND TRANSPORTATION VIAL; AND 6) CONICAL SPRAY JAR ASSEMBLY.
P060022|S001|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice||N|10/20/2008|11/19/2008|||OK30|CHANGE IN SITE FOR THE BIOBURDEN AND ENDOTOXIN TESTING.
P000006|S012|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2008|12/19/2008|||APPR|APPROVAL FOR THREE LARGER CYLINDER SIZES (I.E., LENGTHS OF 24, 26, AND28 CM), AND RELATED CHANGES FOR LARGER PACKAGING, A MODIFICATION TO THE CYLINDER MANUFACTURINGPROCESS, ADDITIONAL LABELS FOR THE LARGER CYLINDER SIZES, REVISED INSTRUCTIONS FOR USE TO INCLUDE ADDITIONAL CATALOG NUMBERS FOR THE NEW CYLINDER SIZES, AND A NEW LABELING STATEMENT THAT RECOMMENDS USE OF THE L00CC RESERVOIR WITH THE NEW LARGER CYLINDER SIZES.
P890003|S152|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODEL 2490C & 2490R CARELINK MONITORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2008|11/14/2008|||OK30|CHANGES TO THE TEST CODES APPLIED DURING THE INLINE QUALITY CONTROL TEST SYSTEM USED FOR THE DEVICE.
P040047|S010|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2008|12/30/2008|||APPR|APPROVAL FOR AN ALTERNATE GLYCERIN SUPPLIER.
P050037|S014|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2008|11/21/2008|||OK30|ALTERNATE VENDOR FOR GLYCERIN, A COMPONENT USED IN THE DEVICE.
P050052|S015|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice||N|10/21/2008|11/21/2008|||OK30|ALTERNATE VENDOR FOR GLYCERIN, A COMPONENT USED IN THE DEVICE.
P990037|S028|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|DUETT PRO SEALING DEVICE, MODEL 1010|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/2008|12/17/2008|||APPR|APPROVAL TO EXTENT THE SHELF LIFE OF THE SODIUM PHOSPHATE PROCOAGULANT DILUENT, USED ONLY IN THE DUET PRO SEALING DEVICE, MODEL 1010, FROM 2 YEARS TO 5 YEARS.
P980022|S037|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMPS & GUARDIAN REAL-TIME GLUCOSE MONITOR|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/21/2008|12/16/2008|||APPR|APPROVAL FOR SOFTWARE CHANGES MADE TO THEGUARDIAN REAL-TIME GLUCOSE MONITOR (CSS7100) AND PARADIGM REAL-TIME INSULININFUSION PUMP (MMT-522, MMT-522K, MMT-722 AND MMT-722K).
P060008|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2008|11/21/2008|||OK30|CHANGE IN SUPPLIER OF A DEVICE COMPONENT.
P980022|S038|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2008|11/14/2008|||OK30|CHANGES TO THE RINSE AND DRY TIMES, ADDITION OF A NEW ADHESIVE FOR THE OCCLUSION SENSOR, AND CHANGE TO THE SENSOR ENCASEMENT.
P910023|S191|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2008|11/14/2008|||APPR|APPROVAL FOR THE MERLIN@HOME MODEL EX1100 TRANSMITTER WITH INDUCTIVE TELEMETRY.
P030054|S107|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2008|11/14/2008|||APPR|APPROVAL FOR THE MERLIN@HOME MODEL EX1100 TRANSMITTER WITH INDUCTIVE TELEMETRY.
P970029|S013|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|TMR HOLMIUM LASER SYSTEM|MNO|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/22/2008|12/30/2008|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010031|S131|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA CRT-D,  MAXIMO II CRT-D AND CONCERTO II CRT-D|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/2008|03/31/2009|||APPR|APPROVAL FOR THE MODEL 9995 V1.2 APPLICATION SOFTWARE WHICH INCLUDES THE LEAD INTEGRITY ALERT FEATURE AND ADDITIONAL SOFTWARE UPDATES.
P980016|S164|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR MAXIMO II DR/VR AND VIRTUOSO II DR/VR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/2008|03/31/2009|||APPR|APPROVAL FOR THE MODEL 9995 V1.2 APPLICATION SOFTWARE WHICH INCLUDES THE LEAD INTEGRITY ALERT FEATURE AND ADDITIONAL SOFTWARE UPDATES.
P060008|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2008|11/20/2008|||OK30|CHANGE TO AN IN-PROCESS TEST METHOD AND CORRESPONDING SPECIFICATIONS.
P060008|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2008|11/20/2008|||OK30|IMPLEMENTATION OF AN IN-PROCESS AUTOMATED MANUFACTURING IMPROVEMENT.
P910023|S192|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2008|11/21/2008|||OK30|ADDITION OF AN ALTERNATE VENDOR TO PACKAGE ICD PLUGS.
P780007|S044|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|POLYMACON SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2008|11/21/2008|||OK30|MIGRATION TO AN IN-BLISTER HYDRATION PROCESS FOR THE POLYMACON 38 LENSES.
P060033|S018|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2008|11/20/2008|||OK30|CHANGE TO THE PACKAGING AND LOADING CONFIGURATIONS USED IN THE STERILIZATION PROCESS.
P050049|S003|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM HBSAG, AXSYM HBSAG CONFIRMATORY AND AXSYM HBSAG CONTROLS|LOM|MI|Real-Time Process||N|10/24/2008|12/17/2008|||APPR|APPROVAL FOR CHANGE OF ASSAY FILES THAT MONITOR LIQUID LEVELS.
P010014|S022|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2008|11/21/2008|||APPR|APPROVAL FOR THE ADDITION OF A CHECK OF THICKNESS PRIOR TO ENGRAVING OF THE MENISCAL BEARING COMPONENTS OF THE BIOMET OXFORD MENISCAL UNICOMPARTMENTAL KNEW SYSTEM TO PREVENT COMPONENTS FROM BEING MIS-ENGRAVED.
P060022|S002|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2008|02/18/2009|||APPR|APPROVAL FOR CHANGES TO THE PACKAGING, LABELING AND DESIGN OF THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL: AKREOS ADVANCED OPTICS ASPHERIC INTRAOCULAR LENS, AO60.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AKREOS AO MICRO INCISION LENS, MODEL MI60L AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA.
P900067|S005|AIR LIQUIDE|6141 EASTON ROAD|P.O. BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN SULFUR HEXAFLUORIDE SF6 GAS|LPO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2008|12/09/2008|||OK30|CHANGE OF SULFUR HEXAFLUORIDE GAS SUPPLIER.
P960040|S179|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELEGIN FAMILY OF ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2008|11/21/2008|||OK30|CHANGES IN THE SOAK PROCESS TIME FOR HIGH VOLTAGE CAPACITORS AND THE ADDITION OF DIGITAL TIMERS TO THE PRIMARY SOAK OVENS.
P010012|S193|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPACITORS SOAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2008|11/21/2008|||OK30|CHANGES IN THE SOAK PROCESS TIME FOR HIGH VOLTAGE CAPACITORS AND THE ADDITION OF DIGITAL TIMERS TO THE PRIMARY SOAK OVENS.
P920015|S049|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2008|11/26/2008|||OK30|MODIFICATION TO THE SLEEVE HEAD BONDING PROCESS AND TO THE ADHESIVE DAB APPLICATION TO THE OVERLAY TUBING SLIT PROCESS.
P030009|S027|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2008|11/13/2008|||OK30|MODIFICATION OF THE MANUFACTURING EQUIPMENT TO ALLOW INCREASED CAPACITY.
P060033|S019|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice||N|10/27/2008|11/13/2008|||OK30|MODIFICATION OF THE MANUFACTURING EQUIPMENT TO ALLOW INCREASED CAPACITY.
P040025|S008|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP SYSTEM|MXM|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/27/2008|12/24/2008|||APPR|APPROVAL FOR MINOR HARDWARE AND SOFTWARE DESIGN CHANGES TO THE OLYMPIC COOL-CAP SYSTEM RELATED TO A CPU (PROCESSOR) THAT HAS GONE END-OF-LIFE.
P980035|S119|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, & SENSIA FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/27/2008|11/25/2008|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE FOR THE L174 HALL SENSOR COMPONENT USED IN THE MEDTRONIC ADAPTA, VERSA AND SENSIA FAMILY OF PACEMAKERS.
P970004|S063|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2008|11/25/2008|||OK30|CHANGE IN THE FINAL CLEAN AND INSPECTION PROCESS FOR THE DEVICE.
P050014|S001|FUJIFILM MEDICAL SYSTEM U.S.A., INC.|419 WEST AVE.||STAMFORD|CT|06902||Full field digital,system,x-ray,mammographic|FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/28/2008|01/09/2009|||APPR|APPROVAL FOR: 1) SOFTWARE VERSION 5.0 WITH 12-BIT OUTPUT ENABLED. CURRENTLY FOR MAMMOGRAPHY,ONLY 10-BIT OUTPUT IS ENABLED SO THIS CHANGE WOULD GIVE THE END USER THE OPTION OF EITHER10-BIT OR 12-BIT OUTPUT FOR MAMMOGRAPHY IMAGES; AND2) LABELING CHANGES MADE TO THE FCRM FUJI CR FOR MAMMOGRAPHY USER GUIDE 1STEDITION JULY, 2006 TO INCLUDE:A) INFORMATION IN CHAPTERS 3 AND 4 WERE REVERSED SO THAT EXPOSURE FACTORS AREDISCUSSED BEFORE AUTOMATIC EXPOSURE CONTROL (AEC) CALIBRATION;B) MORE SPECIFIC X-RAY EXPOSURE INSTRUCTIONS KVP RANGES, AND RECOMMENDED TARGETAND FILTER SELECTION HAVE BEEN ADDED TO HELP FCRM USERS SELECT EXPOSURE SETTINGSBASED ON CONTRAST-TO-NOISE RATIO (CNR); ANDC) INSTRUCTIONS ARE PROVIDED DURING THE SETUP OF THE AEC SYSTEM SO THAT EXPOSURETECHNIQUES WILL BE BASED ON THE X-RAY EXPOSURE SETTINGS RECOMMENDED IN CHAPTER 3.
P980022|S039|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice||N|10/30/2008|11/20/2008|||OK30|CHANGES TO THE SENSOR TO TUBE ASSEMBLY, SEALING AND BEVELING.
P910001|S027|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM|LPC|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2008|03/25/2009|||APPR|APPROVAL FOR: 1) REMOVAL OF BIOBURDEN TESTING FROM THE LOT HISTORY RECORDS (LHR) AS A TEST REQUIRED FOR RELEASE OF PRODUCT, AND 2) CHANGE LAL ENDOTOXIN TEST PROCEDURE TO INSTRUCT QUALITY ASSOCIATES TO COLLECT PRODUCT SAMPLE POST-STERILIZATION.
P960042|S010|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12|MFA|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2008|03/25/2009|||APPR|APPROVAL FOR: 1) REMOVAL OF BIOBURDEN TESTING FROM THE LOT HISTORY RECORDS (LHR) AS A TEST REQUIRED FOR RELEASE OF PRODUCT, AND 2) CHANGE LAL ENDOTOXIN TEST PROCEDURE TO INSTRUCT QUALITY ASSOCIATES TO COLLECT PRODUCT SAMPLE POST-STERILIZATION.
P860019|S230|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2008|04/13/2009|||APPR|APPROVAL FOR A CHANGE TO THE BOND LENGTH SPECIFICATION LIMITS FOR THE CATHETER MANUFACTURING PROCESS.
P020009|S048|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 OTW|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2008|04/13/2009|||APPR|APPROVAL FOR A CHANGE TO THE BOND LENGTH SPECIFICATION LIMITS FOR THE CATHETER MANUFACTURING PROCESS.
P060008|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE OTW|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2008|04/13/2009|||APPR|APPROVAL FOR A CHANGE TO THE BOND LENGTH SPECIFICATION LIMITS FOR THE CATHETER MANUFACTURING PROCESS.
P040016|S034|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE OTW|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2008|04/13/2009|||APPR|APPROVAL FOR A CHANGE TO THE BOND LENGTH SPECIFICATION LIMITS FOR THE CATHETER MANUFACTURING PROCESS.
P030025|S060|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 OTW|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2008|04/13/2009|||APPR|APPROVAL FOR A CHANGE TO THE BOND LENGTH SPECIFICATION LIMITS FOR THE CATHETER MANUFACTURING PROCESS.
P050028|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS TAQMAN HBV TEST||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2008|11/25/2008|||OK30|REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USE DIN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).
P060025|S001|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|ATS 3F AORTIC BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2008|11/26/2008|||OK30|CHANGE IN SUPPLIER FOR THE TAB CLOTH FABRIC.
P970027|S007|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)|MZO|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2008|07/08/2009|||APPR|APPROVAL FOR A CHANGE IN THE ANTIMICROBIAL FORMULATION TO THE AXSYM ANTI-HCV REAGENT SDB2 (SPECIMEN DILUENT).  IN ADDITION, DUE TO THE REFORMULATION OF THE SDB2, THE INSTRUCTION TO USE STERILE WATER FOR TUBING DECONTAMINATION IS NO LONGER A REQUIRED PROCEDURE AND CAN BE REMOVED FROM THE PACKAGE INSERT LABELING.
P000036|S006|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2008|12/03/2008|||OK30|CHANGES TO AN ACCEPTANCE TEST METHOD FOR DERMAGRAFT.
P840064|S037|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT, DUOVISC, DISCOVISC, PROVISC AND CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2008|11/26/2008|||OK30|USE OF A NEW INDUSTRIAL DISINFECTANT FOR THE DISINFECTION OF CLEANROOMS USED DURING THE PRODUCTION PROCESS.
P890047|S025|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2008|11/26/2008|||OK30|USE OF A NEW INDUSTRIAL DISINFECTANT FOR THE DISINFECTION OF CLEANROOMS USED DURING THE PRODUCTION PROCESS.
P970003|S103|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2008|12/19/2008|||APPR|APPROVAL FOR THE ADDITION OF A SOFTWARE ACCESSORY/TOOL REFERRED TO AS THE ¿GENERATOR FIELD UPGRADER¿ (GFU).  THE GFU IS DESIGNED TO BE USED TO UPGRADE SOFTWARE IN THE DEMIPULSE, MODEL 103 AND DEMIPULSE DUO, MODEL 104 PULSE GENERATORS TO EITHER ENHANCE PRE-EXISTING FEATURES OR TO RESOLVE SOFTWARE ANOMALIES.
P990023|S005|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2008|11/26/2008|||OK30|USE OF A NEW INDUSTRIAL DISINFECTANT FOR THE DISINFECTION OF CLEANROOMS USED DURING THE PRODUCTION PROCESS.
P840064|S038|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2008|02/27/2009|||APPR|APPROVAL FOR THE ADDITION OF A SECOND LINE-PERFORM LABELING AND ASSEMBLY OF OPHTHALMIC VISCOSURGICAL DEVICES (OVD).
P950037|S066|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS II FAMILY OF PULSE GENERATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2008|11/21/2008|||APPR|APPROVAL FOR UPDATES TO THE HOME MONITORING SERVICE CENTER USED WITH THE PHILOS II AND CYLOS FAMILIES OF PULSEGENERATORS LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. STRATOS LV-TPULSE GENERATOR. CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND THE KRONOS LV-T AND LUMAX FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P890047|S026|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2008|02/27/2009|||APPR|APPROVAL FOR THE ADDITION OF A SECOND LINE-PERFORM LABELING AND ASSEMBLY OF OPHTHALMIC VISCOSURGICAL DEVICES (OVD).
P980023|S035|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2008|11/21/2008|||APPR|APPROVAL FOR UPDATES TO THE HOME MONITORING SERVICE CENTER USED WITH THE PHILOS II AND CYLOS FAMILIES OF PULSEGENERATORS LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. STRATOS LV-TPULSE GENERATOR. CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND THE KRONOS LV-T AND LUMAX FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P000009|S031|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LEXOS & LUMOS FAMILIES OF ICDS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2008|11/21/2008|||APPR|APPROVAL FOR UPDATES TO THE HOME MONITORING SERVICE CENTER USED WITH THE PHILOS II AND CYLOS FAMILIES OF PULSEGENERATORS LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. STRATOS LV-TPULSE GENERATOR. CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND THE KRONOS LV-T AND LUMAX FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P050023|S018|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2008|11/21/2008|||APPR|APPROVAL FOR UPDATES TO THE HOME MONITORING SERVICE CENTER USED WITH THE PHILOS II AND CYLOS FAMILIES OF PULSEGENERATORS LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. STRATOS LV-TPULSE GENERATOR. CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND THE KRONOS LV-T AND LUMAX FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P070008|S007|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV-T PULSE GENERATOR|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2008|11/21/2008|||APPR|APPROVAL FOR UPDATES TO THE HOME MONITORING SERVICE CENTER USED WITH THE PHILOS II AND CYLOS FAMILIES OF PULSEGENERATORS LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. STRATOS LV-TPULSE GENERATOR. CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND THE KRONOS LV-T AND LUMAX FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P030017|S088|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2008|03/20/2009|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS OF THE 50 (SC-8216-50) AND 70 CM (SC-8216-70) ARTISAN 2X8 SURGICAL ELECTRODE LEADS.
P020004|S039|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track||N|11/03/2008|03/05/2009|||APPR|APPROVAL FOR THE ADDITION OF THE 31 MM GORE EXCLUDERENDOPROSTHESIS. THE 31 MM GORE EXCLUDERS ENDOPROSTHESIS INCLUDES TWO COMPONENTSTHAT WERE NOT INCLUDED IN PRIOR SUBMISSIONS: THE 31 MM TRUNK-IPSILATERAL LEG AND THE 32MM AORTIC EXTENDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GOREEXCLUDERS AAA ENDOPROSTHESIS AND IS INTENDED TO EXCLUDE THE ANEURYSM FROM BLOODCIRCULATION IN PATIENTS WHO HAVE APPROPRIATE ANATOMY AS FOLLOWS:1) ADEQUATE ILIAC/FEMORAL ACCESS;2) INFRARENAL AORTIC NECK TREATMENT DIAMETER RANGE OF 19-29 MM AND A MINIMUM AORTICNECK LENGTH OF 15 MM; 3) PROXIMAL AORTIC NECK ANGULATION LESS THAN OR EQUAL TO 60 DEGREES; AND 4) ILIAC ARTERY TREATMENT DIAMETER RANGE OF 8-18.5 MM AND ILIAC DISTAL VESSEL SEAL ZONE LENGTH OF AT LEAST 10 MM.
P970004|S064|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/03/2008|04/30/2009|||APPR|APPROVAL FOR CLARIFYING LABELING MODIFICATIONS AND EXTENSION OF THE TINED LEAD TEST IMPLANTATION TO 14 DAYS.
P890003|S153|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|LEADS SERVICE & WRENCH KIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2008|12/03/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P900061|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL TRANSVENE LEAD, CABLE HEADER, ACE HEADER, UPSIZING SLEEVE FOR HV LEAD DF-1, UPSIZING SLEEVE, END CAP|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2008|12/03/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P920015|S050|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENOUS,STEROID ELUTING,QUADRIPOLAR,ACTIVE FIXATION, PACE/SENSE VENTRICULAR LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2008|12/03/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P950024|S013|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI EPICARDIAL STEROID ELUTING PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2008|12/03/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P980050|S038|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SVC/CS TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2008|12/03/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P010015|S056|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN BIPOLAR OTW/OTW/CS LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2008|12/03/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P030036|S010|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|LEAD ASSEMBLY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2008|12/03/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P060039|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2008|12/03/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P050044|S007|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2008|11/21/2008|||OK30|CHANGE OF VENDOR AND CHANGE OF MANUFACTURING PARAMETERS.
P030031|S013|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/2008|12/24/2008|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO INCORPORATE RESULTS OF THE COMPLETED POSTMARKET CONDITION OF APPROVAL STUDY FOR THE ATRIAL FLUTTER INDICATION.
P980022|S040|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REALTIME INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2008|11/24/2008|||OK30|CHANGE IN A VENDOR SUPPLYING A COMPONENT OF THE DEVICE.
P890003|S154|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/2008|05/01/2009|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING PROCESS MODIFICATIONS TO THE EXISTING MEDTRONIC CARELINK MONITOR MODEL 2490C TO PRODUCE THE 2490C LOW COST MONITOR.
P980016|S165|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO/VIRTUOSO II DR/VR ICD/SECURA DR/VR ICD/MAXIMO II DR/VR ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/2008|05/01/2009|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING PROCESS MODIFICATIONS TO THE EXISTING MEDTRONIC CARELINK MONITOR MODEL 2490C TO PRODUCE THE 2490C LOW COST MONITOR.
P010031|S132|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/2008|05/01/2009|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING PROCESS MODIFICATIONS TO THE EXISTING MEDTRONIC CARELINK MONITOR MODEL 2490C TO PRODUCE THE 2490C LOW COST MONITOR.
P940040|S010|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST|MWA|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2008|11/25/2008|||OK30|REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USED IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).
P910001|S028|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ANGIOPLASTY/LASER/CORONARY DEVICE|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2008|12/11/2008|||OK30|CHANGE TO AN IN-PROCESS MANUFACTURING AID.
P020047|S013|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION RX FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2008|12/04/2008|||OK30|ADDITION OF AN IN-PROCESS VISUAL INSPECTION STEP TO THE CATHETER MANUFACTURING PROCESS.
P030009|S028|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2008|12/24/2008|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM.
P970020|S053|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK RX ZETA CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2008|12/04/2008|||OK30|ADDITION OF AN IN-PROCESS VISUAL INSPECTION STEP TO THE CATHETER MANUFACTURING PROCESS.
P070015|S007|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V RX EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2008|12/04/2008|||OK30|ADDITION OF AN IN-PROCESS VISUAL INSPECTION STEP TO THE CATHETER MANUFACTURING PROCESS.
P790017|S098|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2008|12/24/2008|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM.
P000012|S018|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2008|12/04/2008|||OK30|REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USED IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USED IN THE COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST WITH THE ACTIVATOR, 4,5 DICYANOIMIDAZOLE (DCI).
P960040|S182|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN FAMILY|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2008|12/11/2008|||APPR|APPROVAL FOR THE PROGRAMMER SW MODEL 2868 V1.04 AND NOMINAL PARAMETERS LOADED DURING MANUFACTURING.
P010012|S194|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2008|12/11/2008|||APPR|APPROVAL FOR THE PROGRAMMER SW MODEL 2868 V1.04 AND NOMINAL PARAMETERS LOADED DURING MANUFACTURING.
P060033|S020|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2008|12/04/2008|||OK30|ALTERNATIVE MANUFACTURING SITE, MEDTRONIC MEXICO, FOR A SUBASSEMBLY COMPONENT OF THE FINISHED DEVICE.
P050037|S015|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2008|12/05/2008|||OK30|ALTERNATE OVEN FOR THE LOSS ON DRYING FINAL TESTING OF THE DEVICE.
P050052|S016|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2008|12/05/2008|||OK30|ALTERNATE OVEN FOR THE LOSS ON DRYING FINAL TESTING OF THE DEVICE.
P040047|S011|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2008|03/11/2009|||APPR|APPROVAL FOR A SECOND CONVECTION OVEN.
P890003|S155|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK PROGRAMMER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2008|02/24/2009|||APPR|APPROVAL FOR THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER RADIO FREQUENCY TRANSCEIVER (RFT).
P060008|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE OVER-THE-WIRE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2008|11/26/2008|||OK30|CHANGE IN THE METHOD USED TO CREATE THE PROXIMAL MARKS ON THE SHAFT OF THE OVER-THE-WIRE CATHETER.
P030039|S012|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2008|12/04/2008|||OK30|RECONFIGURATION OF THE EXISTING APPROVED HAYWARD FACILITY TO INCLUDE A NEW MANUFACTURING AREA.
P030054|S108|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2008|12/04/2008|||OK30|ALTERNATE SUPPLIERS FOR VARIOUS DISCRETE COMPONENTS USED ON THE LOW VOLTAGE AND HIGH VOLTAGE HYBRID ASSEMBLY OF IMPLANTABLE DEVICES.
P880086|S170|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2008|12/04/2008|||OK30|ALTERNATE SUPPLIERS FOR VARIOUS DISCRETE COMPONENTS USED ON THE LOW VOLTAGE AND HIGH VOLTAGE HYBRID ASSEMBLY OF IMPLANTABLE DEVICES.
P910023|S193|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2008|12/04/2008|||OK30|ALTERNATE SUPPLIERS FOR VARIOUS DISCRETE COMPONENTS USED ON THE LOW VOLTAGE AND HIGH VOLTAGE HYBRID ASSEMBLY OF IMPLANTABLE DEVICES.
P030035|S049|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2008|12/04/2008|||OK30|ALTERNATE SUPPLIERS FOR VARIOUS DISCRETE COMPONENTS USED ON THE LOW VOLTAGE AND HIGH VOLTAGE HYBRID ASSEMBLY OF IMPLANTABLE DEVICES.
P790018|S050|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/09/2008|||OK30|USE OF A NEW MODEL AIR SAMPLER.
P960058|S073|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/10/2008|12/09/2008|||APPR|APPROVAL FOR A NEW REPAIR SERVICE FOR SPEECH PROCESSORS WITH ASSOCIATED LETTERS TO PATIENTS (ADULT, PEDIATRIC) WHICH ACCOMPANIES THE REPLACEMENT PROCESSOR.
P980049|S043|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ISOLINE 2CR, ISOLINE 2CT STEROID ELUTING PACING LEADS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/10/2008|||OK30|MANUFACTURING SITE CHANGE FOR THE STEROID COMPONENT OF THE DEVICE.
P060027|S007|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|03/26/2009|||APPR|APPROVAL TO CHANGE THE LOCATION FOR MANUFACTURING THE STEROID COMPONENT OF THE DEVICE.
P020047|S014|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (CSS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/10/2008|||OK30|MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.
P970020|S054|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (CSS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/10/2008|||OK30|MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.
P810046|S227|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|SIMPSON-ROBERT FAMILY OF CORONARY DILATATION CATHETERS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/10/2008|||OK30|MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.
P040012|S028|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/10/2008|||OK30|MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.
P040014|S009|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/10/2008|||OK30|ADDITION OF AN ALTERNATIVE TUBE FUSING PROCESS.
P040042|S014|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/10/2008|||OK30|ADDITION OF AN ALTERNATIVE TUBE FUSING PROCESS.
P060019|S007|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/10/2008|||OK30|ADDITION OF AN ALTERNATIVE TUBE FUSING PROCESS.
P060033|S021|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/10/2008|01/08/2009|||APPR|APPROVAL FOR A SHELF LIFE EXTENSION FO THE PRODUCT, FROM 18 MONTHS TO 24 MONTHS.
P930027|S007|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATIONPSA|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/30/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED, GWYNEDD, UNITED KINGDOM.
P010050|S006|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD., WALES, UNITED KINGDOM.
P060005|S001|SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED|GLYN RHONWY. LLANBERIS|CAERNARFON|GWYNEDD, LL55||4EL||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/30/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED, GWYNEDD, UNITED KINGDOM.
P010051|S005|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD., WALES, UNITED KINGDOM.
P010052|S005|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD., WALES, UNITED KINGDOM.
P010053|S004|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2008|12/16/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD., WALES, UNITED KINGDOM.
P960058|S074|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2008|03/11/2009|||APPR|APPROVAL TO CHANGE TO THE PLATINUM SOLID RING.
P060008|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2008|11/26/2008|||OK30|IMPLEMENTATION OF AN IN-PROCESS AUTOMATED MANUFACTURING IMPROVEMENT.
P950029|S039|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY SR/DR & RHAPSODY SR/DR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2008|02/04/2009|||APPR|APPROVAL FOR THE REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1.
P060033|S022|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2008|12/11/2008|||OK30|ADDITIONAL AUTOMATION IN THE STENT SEGMENT LOADING PROCESS.
P900022|S012|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2008|02/04/2009|||APPR|APPROVAL FOR THE REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1.
P980049|S044|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ISOLINE 2CR/2CT DEFIBRILLATION LEADS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2008|02/04/2009|||APPR|APPROVAL FOR THE REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1.
P060027|S008|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2008|02/04/2009|||APPR|APPROVAL FOR THE REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1.
P980035|S120|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA/SIGMA/ENPULSE/ADAPTA/VERSA/SENSIA PACEMAKER FAMILIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2008|12/11/2008|||OK30|NEW SPRAY WASH EQUIPMENT AND MODIFICATION OF THE BARB FASTENER AND PIN/STRAP CLEANING PROCESS.
P970012|S046|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2008|12/11/2008|||OK30|NEW SPRAY WASH EQUIPMENT AND MODIFICATION OF THE BARB FASTENER AND PIN/STRAP CLEANING PROCESS.
P890003|S156|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY SR, ENRHYTHM IPG MODEL P150DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2008|12/11/2008|||OK30|NEW SPRAY WASH EQUIPMENT AND MODIFICATION OF THE BARB FASTENER AND PIN/STRAP CLEANING PROCESS.
N16895|S091|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS (POLYMACON) CONTACT LENS|LPM|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2008|05/05/2009|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE RESIN SUNOCO D-115A TO FORM THE BLISTER PACKAGE CONTAINER FOR THE DEVICE.
P980006|S014|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION/PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2008|05/05/2009|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE RESIN SUNOCO D-115A TO FORM THE BLISTER PACKAGE CONTAINER FOR THE DEVICE.
P000044|S019|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2008|01/14/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS IN PENCOED BRIDGEND, UNITED KINGDOM.
P030024|S009|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2008|01/14/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS IN PENCOED BRIDGEND, UNITED KINGDOM.
P030026|S015|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2008|01/14/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS IN PENCOED BRIDGEND, UNITED KINGDOM.
P000014|S017|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2008|01/14/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS IN PENCOED BRIDGEND, UNITED KINGDOM.
P040044|S010|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2008|01/08/2009|||APPR|APPROVAL FOR MATERIAL AND DESIGN CHANGES TO THE ADVANCER TUBE ASSEMBLY.
P030054|S109|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2008|11/26/2008|||APPR|APPROVAL FOR MINOR CHANGES TO THE XENA CONTROLLER INTEGRATED CIRCUIT CHIP IN THE CURRENT AND PROMOTE ICD/CRT-D DEVICES.
P010021|S014|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2008|01/14/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS IN PENCOED BRIDGEND, UNITED KINGDOM.
P910023|S194|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2008|11/26/2008|||APPR|APPROVAL FOR MINOR CHANGES TO THE XENA CONTROLLER INTEGRATED CIRCUIT CHIP IN THE CURRENT AND PROMOTE ICD/CRT-D DEVICES.
P000029|S052|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2008|12/12/2008|||OK30|BACKUP SUPPLIER TO INCLUDE NEW IN-HOUSE QUALITY CONTROL TESTING FOR A RAW MATERIAL USED IN THE DEFLUX® INJECTABLE GEL MANUFACTURING PROCESS.
P040033|S008|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2008|01/12/2009|||APPR|APPROVAL FOR THE ADDITION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND REVISIONS TO THE SURGICAL TECHNIQUE.
P060033|S023|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/14/2008|01/23/2009|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P030006|S020|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2008|12/09/2008|||OK30|ADDITION OF AN ADHESIVE IN THE MANUFACTURING OF THE RECTAL TEMPERATURE MONITOR.
P060033|S024|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2008|11/26/2008|||OK30|CHANGES TO THE IN-PROCESS MONITORING AT THE PC OVERSPRAY WORKSTEP.
P060030|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2008|12/04/2008|||OK30|REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USED IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USED IN THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST WITH THE ACTIVATOR, 4,5 DICYANOIMIDAZOLE (DCI).
P030009|S029|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2008|12/15/2008|||OK30|REMOVAL OF DUPLICATE INSPECTION AT COMPLETION OF AN IN-PROCESS WORK STEP.
P060033|S025|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2008|12/16/2008|||OK30|EQUIPMENT MODIFICATION TO THE SPRAY MACHINE USED TO APPLY THE DRUG COATING LAYER TO THE DEVICES.
P970008|S041|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2008|12/09/2008|||OK30|MINOR CHANGES IN THE MANUFACTURING OF THE DIAPHRAGM SEAL.
P980016|S166|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA ICD/MAXIMO II ICD/VIRTUOSO II DR/VR|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2008|04/01/2009|||APPR|APPROVAL OF THE HYBRID FINAL FUNCTIONAL TESTING.
P010031|S133|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2008|04/01/2009|||APPR|APPROVAL OF THE HYBRID FINAL FUNCTIONAL TESTING.
P070015|S008|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2008|12/15/2008|||OK30|ADDITIONAL PROCESS CONTROL STEP FOR THE PRE-STERILE PACKAGING PROCESS.
P050023|S019|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/2008|03/31/2009|||APPR|APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS.
P030025|S061|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 /TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2008|12/16/2008|||OK30|ALTERNATE METHOD FOR FINISHED DEVICE PACKAGING.
P060008|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|30-Day Notice||N|11/17/2008|12/16/2008|||OK30|ALTERNATE METHOD FOR FINISHED DEVICE PACKAGING.
P950037|S067|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PROGRAMMER SOFTWARE (ICS 3000 802.U/2)|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/2008|03/31/2009|||APPR|APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS.
P980023|S036|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|PROGRAMMER SOFTWARE (ICS 3000 802.U/2)|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/2008|03/31/2009|||APPR|APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS.
P000009|S032|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PROGRAMMER SOFTWARE (ICS 3000 802.U/2)|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/2008|03/31/2009|||APPR|APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS.
P070008|S008|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV AND LV-T PULSE GENERATORS|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/2008|03/31/2009|||APPR|APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS.
P040023|S012|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2008|12/30/2008|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CERAMTEC AG, MARKTREDWITZ, GERMANY, FOR MANUFACTURING OF THE BIOLOX FORTE CERAMIC HEADS AND LINERS.
P960058|S075|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2008|06/12/2009|||APPR|APPROVAL FOR IMPROVEMENTS TO THE MANUFACTURING PROCESS FOR THE MAGNET ASSEMBLY USED IN THE HIRES90K IMPLANTABLE COCHLEAR STIMULATOR.
P860003|S050|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2008|12/19/2008|||OK30|TRANSFER OF FINISH PRODUCT TESTING FROM THE ORIGINAL MANUFACTURER TO THE CONTRACT MANUFACTURER.
P040043|S026|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2008|12/19/2008|||OK30|CHANGE IN THE METHOD OF COOLING THE ENDOPROSTHESIS.
P930031|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2008|12/16/2008|||OK30|CHANGE IN THE STERILE LOAD CONFIGURATION AND THE STERILIZATION LOAD DENSITY OF THE CYCLE USED BY THE DEVICES.
P980033|S015|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice||N|11/19/2008|12/16/2008|||OK30|CHANGE IN THE STERILE LOAD CONFIGURATION AND THE STERILIZATION LOAD DENSITY OF THE CYCLE USED BY THE DEVICES.
P960030|S024|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|ISOFLEX OPTIM FAMILY OF LEADS|NVY|CV|30-Day Notice||N|10/29/2008|11/26/2008|||OK30|ELIMINATION OF THE PLASMA PRIMING PROCESS.
P980023|S037|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX SD 60/16 STEROID-ELUTING, ACTIVE FIXATION ICD LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2008|01/05/2009|||APPR|APPROVAL FOR THE ADDITION OF A 61.2 CM LEAD IN ADDITION TO THE PREVIOUSLY APPROVED 65 AND 75 CM LEADS.
P040037|S012|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|01/26/2009|||OK30|CHANGE TO THE EPTFE CUTTING PROCESS.
P060040|S002|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/20/2008|12/03/2008|||APPR|APPROVAL FOR THE ADDITION OF A CAUTION STATEMENT ''WARNING: PRECLOT THEGRAFT!" TO THE PACKAGE LABELS FOR THE OUTFLOW GRAFT WITH BEND RELIEF (CATALOG# 102563) ANDINFLOW CONDUIT (CATALOG # 102564). THIS CAUTION STATEMENT IS TO HIGHLIGHT INFORMATION CURRENTLYFOUND IN THE HEARTMATE II INSTRUCTIONS FOR USE, SECTION 13.4, WHICH INSTRUCTS USERS TO PRE-CLOT THE TWO COMPONENTS PRIOR TO IMPLANTATION.
P960040|S183|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM2/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|12/18/2008|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE DESICCANT MATERIAL.
P010012|S195|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTACT RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|12/18/2008|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE DESICCANT MATERIAL.
P980035|S122|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/ENPULSE/ENRHYTHM/SIGMA IPG/MEDTRONIC 350/ADAPTA/VERSA/SENSIA/RELIA/AT500|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|12/17/2008|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.
P010031|S134|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC FAMILIES OF ICDS/CONCERTO CRT-D/MAXIMO II/CONSULTA/CONCERTO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|12/17/2008|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.
P010015|S057|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III CRT-P & INSYNC CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|12/17/2008|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.
P970012|S047|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|12/17/2008|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.
P890003|S158|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|12/17/2008|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.
P980016|S167|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO& MAXIMO II IPG/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/ONYX/VIRTUOSO FAMILY OF ICDS/SECURA ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2008|12/17/2008|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.
P960040|S184|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT/TELIGEN/VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2008|12/18/2008|||OK30|ADDITIONAL COMPONENT SUPPLIER.
P010012|S196|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL 3/LIVIAN/COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2008|12/18/2008|||OK30|ADDITIONAL COMPONENT SUPPLIER.
P030017|S090|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION SYSTEM|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/2008|12/09/2008|||APPR|APPROVAL FOR LABELING CHANGES ON THE INTRODUCER INSTRUCTIONS FOR USE.
P010012|S197|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2008|12/18/2008|||OK30|ADDITIONAL SUPPLIER FOR LOW-VOLTAGE CAPACITORS.
P960040|S185|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2008|12/18/2008|||OK30|ADDITIONAL SUPPLIER FOR LOW-VOLTAGE CAPACITORS.
P000058|S030|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT- CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice||N|11/21/2008|01/20/2010|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF BOVINE ACHILLES TENDON FOR THE MANUFACTURE OF THE ABSORBABLE COLLAGEN SPONGE (ACS) COMPONENT OF THE INFUSE BONE GRAFT.
P000054|S019|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice||N|11/21/2008|01/20/2010|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF BOVINE ACHILLES TENDON FOR THE MANUFACTURE OF THE ABSORBABLE COLLAGEN SPONGE (ACS) COMPONENT OF THE INFUSE BONE GRAFT.
P050053|S010|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice||N|11/21/2008|01/20/2010|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER OF BOVINE ACHILLES TENDON FOR THE MANUFACTURE OF THE ABSORBABLE COLLAGEN SPONGE (ACS) COMPONENT OF THE INFUSE BONE GRAFT.
P840064|S039|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT, DUOVISC, AND DISCOVIS OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2008|12/23/2008|||OK30|USE OF ELECTRONIC BATCH RECORDING OF BUFFERING/ COMPOUNDING, FILL ORDERS AND STERILIZATION OF REACTORS/VESSELS FOR THE ALCON OPHTHALMIC VISCOSURGICAL DEVICES.
P890047|S027|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice||N|11/24/2008|12/23/2008|||OK30|USE OF ELECTRONIC BATCH RECORDING OF BUFFERING/ COMPOUNDING, FILL ORDERS AND STERILIZATION OF REACTORS/VESSELS FOR THE ALCON OPHTHALMIC VISCOSURGICAL DEVICES.
P990023|S006|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice||N|11/24/2008|12/23/2008|||OK30|USE OF ELECTRONIC BATCH RECORDING OF BUFFERING/ COMPOUNDING, FILL ORDERS AND STERILIZATION OF REACTORS/VESSELS FOR THE ALCON OPHTHALMIC VISCOSURGICAL DEVICES.
P020004|S040|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/2008|04/08/2009|||APPR|APPROVAL FOR THE DISTRIBUTION OF THE 2008 ANNUAL CLINICAL UPDATE TO PHYSICIAN USERS FOR THE DEVICE.
P980040|S026|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRULIC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2008|12/23/2008|||OK30|CHANGE IN THE SAMPLING PLAN USED FOR DIMENSIONAL INSPECTION OF THREE-PIECE SOFT ACRYLIC INTRAOCULAR LENSES.
P960028|S031|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL ACRYLIC IOL|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2008|12/23/2008|||OK30|CHANGE IN THE SAMPLING PLAN USED FOR DIMENSIONAL INSPECTION OF THREE-PIECE SOFT ACRYLIC INTRAOCULAR LENSES.
P990080|S032|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECHNIS ACRYLIC IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2008|12/23/2008|||OK30|CHANGE IN THE SAMPLING PLAN USED FOR DIMENSIONAL INSPECTION OF THREE-PIECE SOFT ACRYLIC INTRAOCULAR LENSES.
P980022|S041|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2008|01/30/2009|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE PARADIGM REAL-TIME INSULIN PUMP (MMT-551 AND MMT-722) TO CHANGE THE KEYPAD OVERLAY COLORS TO MATCH THE EXISTING COLOR OF THE PUMP CASE AND TO ADD A NEW CASE COLOR WITH MATCHING KEYPAD OVERLAY.
P020018|S030|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2008|12/19/2008|||OK30|ADDITION OF A CONTRACT MANUFACTURER IN THE CONSTRUCTION OF SUBASSEMBLY COMPONENTS.
P910023|S195|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT RF AND PROMOTE RF FAMILY OF DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2008|12/23/2008|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE HEADER COMPONENT ON ALL ST. JUDE MEDICAL CURRENT RF AND PROMOTE (UNITY) FAMILY DEVICES.
P030054|S110|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CURRENT RF AND PROMOTE RF FAMILY OF DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2008|12/23/2008|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE HEADER COMPONENT ON ALL ST. JUDE MEDICAL CURRENT RF AND PROMOTE (UNITY) FAMILY DEVICES.
P000006|S013|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2008|12/22/2008|||OK30|USE OF A NEW METHOD FOR MARKING THE SALINE FILLED TESTICULAR PROSTHESIS AND THE TITAN INFLATABLE PENILE PROSTHESIS AND FOR BORING SUTURE HOLES ON THE TITAN INFLATABLE PENILE PROSTHESIS.
P020003|S006|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Prosthesis, testicular|SALINE FILLED TESTICULAR PROSTHESIS|FAF|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2008|12/22/2008|||OK30|USE OF A NEW METHOD FOR MARKING THE SALINE FILLED TESTICULAR PROSTHESIS AND THE TITAN INFLATABLE PENILE PROSTHESIS AND FOR BORING SUTURE HOLES ON THE TITAN INFLATABLE PENILE PROSTHESIS.
P010012|S198|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL RF FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2008|12/22/2008|||OK30|ADDITION OF A COMPONENT SUPPLIER FOR THE INDUCTORS.
P030017|S091|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/2008|06/19/2009|||APPR|APPROVAL FOR THE REMOTE CONTROL SC-5212.
P970051|S048|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/2008|08/28/2009|||APPR|APPROVAL FOR THE CI512 AND CI513 COCHLEAR IMPLANTS.  THE CI512 AND CI513 IMPLANTS REPRESENT MODIFICATIONS TO THE NUCLEUS FREEDOM COCHLEAR IMPLANT (ALSO CALLED THE CI24RE).
P060037|S007|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM|NJL|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/2008|01/23/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE APPROVED SURGICAL TECHNIQUE TO ADD AN OPTIONAL TECHNIQUE FOR MAKING THE FEMORAL BONE CUTS FOR THE LPS-FLEX MOBILE FEMORAL COMPONENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMS AND IS INDICATED FOR PATIENTS WITH SEVERE KNEE PAIN AND DISABILITY DUE TO OSTEOARTHRITIS, PRIMARY AND SECONDARY TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS OF THE FEMORAL CONDYLE, AND MODERATE VALGUS, VARUS, OR FLEXION DEFORMITIES (I.E., VALGUS/VARUS DEFORMITY OF <=15 DEGREES, FIXED FLEXION DEFORMITY OF <=10 DEGREES).
P980022|S042|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|12/16/2008|||OK30|CHANGE IN A VENDOR SUPPLYING A COMPONENT FOR THE DEVICE.
P040024|S030|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|12/23/2008|||OK30|REPLACEMENT OF A SENSOR ON THE ASSEMBLY LINE.
P980016|S168|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO ICD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|04/16/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID TEST USED ON MULTIPLE IMPLANTABLE DEVICES.
P010031|S135|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO CRT-D||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|04/16/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID TEST USED ON MULTIPLE IMPLANTABLE DEVICES.
P910023|S196|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/26/2008|12/16/2008|||APPR|APPROVAL FOR ENHANCEMENTS TO THE SOFTWARE (VERSION 3.1) USED IN THE ST. JUDE MEDICAL MERLIN.NET SYSTEM.
P030005|S055|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/26/2008|01/23/2009|||APPR|APPROVAL FOR: 1) REPLACEMENT OF THE POLYMIDE TUBING WITH POLYETHERETHERKTONE (PEEK) TUBING ON THE PULSE GENERATOR PG HEADER ASSEMBLIES; 2) THE USE OF A COMBINATION OF NATURAL AND COLORIZED PEEK TO ASSIST MANUFACTURING OPERATORS; AND 3) THE ADDITION OF AN EXTRA PLASMA CLEANING STEP TO ENSURE THAT THE BOND FORMED BETWEEN THE MEDICAL ADHESIVE APPLIED TO THE BASE OF THE WIRE AND THE PEEK INSULATION IS STRONG.
P010031|S136|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC SENTRY/MAXIMO CRT-D/INSYNC II PROTECT & MARQUIS/CONCERTO ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|12/24/2008|||OK30|CHANGE IN MANUFACTURING LOCATION OF THE CHIP RESISTORS.
P990001|S047|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C-SERIES & T-SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|12/24/2008|||OK30|CHANGE IN MANUFACTURING LOCATION OF THE CHIP RESISTORS.
P980035|S123|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900 IPG & ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|12/24/2008|||OK30|CHANGE IN MANUFACTURING LOCATION OF THE CHIP RESISTORS.
P980016|S169|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR/VR/MAXIMO DR/VR/INTRINSIC/ENTRUST/VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|12/24/2008|||OK30|CHANGE IN MANUFACTURING LOCATION OF THE CHIP RESISTORS.
P970012|S048|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|12/24/2008|||OK30|CHANGE IN MANUFACTURING LOCATION OF THE CHIP RESISTORS.
P040023|S013|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2008|12/19/2008|||OK30|CHANGE IN THE MASKING PROCESS OF THE GRIT BLASTING OPERATION.
P040040|S006|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/28/2008|02/04/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S051|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESIS, MODEL 7000 AND 7000TFX|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2008|01/27/2009|||APPR|APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS, AND FOR A NEW CARTON FOR THE EXISTING 3.8 OZ JAR AND ITS ACCOMPANYING PACKAGING SYSTEMS, AND ASSOCIATED LABELING.
P050020|S008|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/28/2008|10/29/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSEMONITORING SYSTEM RECEIVER SOFTWARE. THE PRIMARY PURPOSE OF THE NEW SOFTWARE IS TO ALLOW USERS TO OBTAIN CONTINUOUS GLUCOSE DATA AS QUICKLY AS POSSIBLE AFTER INSERTION OF THE SENSOR.  THE NEWALGORITHM CHANGES THE CALIBRATION TIME TO 1, 2, 10, 24 AND 72 HOURS, WITH GLUCOSE DATA BEINGAVAILABLE AT ONE HOUR.  OTHER CHANGES ARE THE INCREASE TO ALLOWABLE RANGE FOR GLUCOSE CALIBRATION,INCREASE TO THE ALLOWABLE GLUCOSE RATE CHANGE AND THE ADDITION OF A CALIBRATION LAG CORRECTION.ADDITIONAL CHANGES WERE MADE TO THE RECEIVER SOFTWARE/USER INTERFACE; THE BACKLIGHT WILL NOWALWAYS BE ON WHEN THE RECEIVER IS DISPLAYING INFORMATION, THE SCREEN TIMEOUT WILL BE 20 SECONDS AND THERE WILL BE NO ABANDON ALARM FEATURE.
P860004|S102|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2008|02/06/2009|||APPR|APPROVAL FOR A NEW COAGULOPATHIES WARNING.
P910023|S197|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2008|12/19/2008|||APPR|APPROVAL FOR THE VERSION 3.1 OF THE MODEL EX2000 SOFTWARE FOR THE MERLIN@HOME DEVICES.
P990034|S012|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2008|02/06/2009|||APPR|APPROVAL FOR A NEW COAGULOPATHIES WARNING.
P030054|S111|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2008|12/19/2008|||APPR|APPROVAL FOR THE VERSION 3.1 OF THE MODEL EX2000 SOFTWARE FOR THE MERLIN@HOME DEVICES.
P900009|S029|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 4000+BONE HEALING SYSTEM|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2008|12/18/2008|||OK30|APPROVAL TO CHANGE THE LOCATION OF THE DISTRIBUTION AND STORAGE FACILITIES TO A FACILITY IN MEMPHIS, TENNESSEE.
P040033|S009|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING SYSTEM|NXT|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2008|12/18/2008|||OK30|CHANGE IN LOCATION OF THE DISTRIBUTION AND STORAGE FACILITIES TO A FACILITY IN MEMPHIS, TENNESSEE.
P030022|S011|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2008|12/18/2008|||OK30|CHANGE IN LOCATION OF THE DISTRIBUTION AND STORAGE FACILITIES TO A FACILITY IN MEMPHIS, TENNESSEE.
P060008|S008|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2008|05/21/2009|09M-0255|06/03/2009|APPR|APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 2.25 MM TAXUSLIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THIS DEVICE SIZE WILL BE MARKETED UNDER THETRADE NAME TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS), AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THETREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES > =2.25 MM TO <= 4.00 MM IN DIAMETER INLESIONS <= 28 MM IN LENGTH.
P000007|S019|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2008|12/17/2008|||OK30|ADDITIONAL SUPPLIER FOR SEWING THREAD TWISTING.
P010041|S018|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2008|12/17/2008|||OK30|ADDITIONAL SUPPLIER FOR SEWING THREAD TWISTING.
P870077|S030|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2008|12/17/2008|||OK30|ADDITIONAL SUPPLIER FOR SEWING THREAD TWISTING.
P870056|S031|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS & BIOPROSTHETIC VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2008|12/17/2008|||OK30|ADDITIONAL SUPPLIER FOR SEWING THREAD TWISTING.
P860057|S052|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2008|12/17/2008|||OK30|ADDITIONAL SUPPLIER FOR SEWING THREAD TWISTING.
P960058|S076|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/2008|09/10/2010|||APPR|APPROVAL FOR THE OFF-THE-EAR-POWER (EOP) ACCESSORIES DESIGNED TO BE USED WITH THE BEHIND-THE-EAR (BTE) EXTERNAL SOUND PROCESSORS AURIA OR HARMONY.
P970003|S104|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/26/2008|07/23/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010050|S007|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE & IMMULITE 2000 HBSAG ASSAY|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/2008|02/09/2009|||APPR|APPROVAL FOR REPLACEMENT OF THE SODIUM BASED BUFFER WITH POTASSIUM PHOSPHATEBUFFER AND ADDITION OF 2.0% NORMAL MOUSE SERUM AND 1.2% E-AMINO-N-CAPROIC ACID IN REAGENT A,AND THE ADDITION OF 0.2% SODIUM HEPARIN IN REAGENT B FOLLOWED BY REFILTERING OF DILUENT, AND ISINDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS BVIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.
P920046|S006|FEMCARE LTD.|STUART COURT, SPURSHOLT PLACE, SALISBURY RD|ROMSEY|HAMPSHIRE||SO516||Laparoscopic contraceptive tubal occlusion device|FEMCARE FILSHIE CLIP|KNH|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|12/02/2008|01/30/2009|||APPR|APPROVAL FOR A CHANGE TO THE SILICONE PROFILE OF THE DEVICE.
P920046|S007|FEMCARE LTD.|STUART COURT, SPURSHOLT PLACE, SALISBURY RD|ROMSEY|HAMPSHIRE||SO516||Laparoscopic contraceptive tubal occlusion device|FEMCARE FILSHIE CLIP|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2008|01/08/2009|||OK30|MODIFICATION TO THE DE-FLASHING PROCESS.
P900007|S006|Cook Incorporated|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||CATHETER, SAMPLING, CHORIONIC VILLUS|COOK CHORIONIC VILLUS SAMPLING SET|LLX|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2008|03/05/2009|||OK30|MODIFICATION TO THE OBTURATOR HANDLE AND THE TECHNIQUE FOR AFFIXING IT TO THE OBTURATOR WIRE.
P000021|S013|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/2008|05/19/2010|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) DETECTION TECHNOLOGY FROM SPECTROPHOTOMETRY TO CHEMILUMINESENCE2) APPROPRIATE REAGENT PROCESS CHANGES TO ACCOMMODATE CHEMILUMINESENCE DETECTION3) USAGE ON THE DIMENSION VISTA 1500 SYSTEM4) USAGE ON THE DIMENSION VISTA 3000T SYSTEM WHICH CONSISTS OF TWO DIMENSION VISTA1500 SYSTEMS CONNECTED BY A SAMPLE TRACK TRANSPORT MECHANISM5) USAGE ON THE DIMENSION VISTA 1500 SYSTEM CONNECTED TO THE STREAMLAB ANALYTICALWORKCELL LABORATORY AUTOMATION SYSTEM6) THE NEW DIMENSION VISTA PSA CALIBRATOR FOR USE WITH THE DIMENSION VISTA TPSA AND FPSA METHODS.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIMENSION VISTA TPSA FLEXREAGENT CARTRIDGE AND IS INDICATED FOR THE FOLLOWING USES:THE TPSA METHOD IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PROSTATESPECIFIC ANTIGEN (PSA) IN HUMAN SERUM AND PLASMA ON THE DIMENSION VISTA SYSTEM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN AID IN THEMANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.THE DIMENSION VISTA PSA CALIBRATOR WILL BE MARKETED SEPARATELY FOR USE WITH THE DIMENSIONVISTA TPSA FLEX REAGENT AND IS INDICATED FOR THE CALIBRATION OF TOTAL (TPSA) AND FREE (FPSA) PROSTATE SPECIFIC ANTIGEN METHODS ON THE DIMENSION VISTA SYSTEMS.
P020027|S009|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/2008|05/17/2010|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) DETECTION TECHNOLOGY FROM SPECTROPHOTOMETRY TO CHEMILUMINESENCE;2) APPROPRIATE REAGENT PROCESS CHANGES TO ACCOMMODATE CHEMILUMINESENCE DETECTION;3) USAGE ON THE DIMENSION VISTA 1500 SYSTEM;4) USAGE ON THE DIMENSION VISTA 3000T SYSTEM WHICH CONSISTS OF TWO DIMENSION VISTA1500 SYSTEMS CONNECTED BY A SAMPLE TRACK TRANSPORT MECHANISM; AND5) USAGE ON THE DIMENSION VISTA 1500 SYSTEM CONNECTED TO THE STREAMLAB ANALYTICALWORKCELL LABORATORY AUTOMATION SYSTEM.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIMENSION VISTA FPSA FLEXREAGENT CARTRIDGE AND IS INDICATED FOR:THE FPSA METHOD FOR THE DIMENSION VISTA SYSTEM IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE FREE PROSTATESPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM AND PLASMA.  MEASUREMENTS OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) METHOD ON DIMENSION VISTA SYSTEN TO CALCULATE FPSA TO TPSA RATIO EXPRESSED AS A PERCENT FPSA.  THE PERCENT FPSA IS USED AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATE CONDITIONS IN MEN 50  YEARS OR OLDER WITH TPSA OF 4.0 TO 1.0 NG/ML AND DRE FINDINGS NOT SUSPICIOUS FOR CANCER.  PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.
P040024|S031|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2008|12/23/2008|||OK30|REPLACEMENT OF A SEMI-QUANTITATIVE TEST METHOD WITH A QUANTITATIVE TEST METHOD.
P010032|S027|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|S-SERIES LAMITRODES|LGW|NE|30-Day Notice||N|12/03/2008|01/10/2009|||OK30|CHANGE IN THE CLEANING PROCEDURE.
P980035|S124|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/650/700/800/900/ENPULSE/ADAPTA/VERSA/SENSIA/RELIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2008|12/24/2008|||OK30|CHANGE IN THE PROCESS FLOW FOR THE MANUFACTURING LEAN LINE FOR THE DEVICES.
P980016|S170|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA MAXIMO II, VIRTUOSO DR/VR II FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2008|04/27/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID TEST SOFTWARE.
P010031|S137|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA/MAXIMO II/CONCERTO II CRT-DS||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2008|04/27/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID TEST SOFTWARE.
P020036|S012|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/03/2008|12/11/2008|||APPR|APPROVAL TO INCORPORATE AN ADDITIONAL PRECAUTION INTO THE INSTRUCTIONS FOR USE TO ADDRESS THE POTENTIAL FOR STENT FRACTURES THAT MAY OCCUR WITH SELF-EXPANDING STENTS SUCH AS THE CORDIS SMART STENT SYSTEMS.
P030047|S016|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE NITINOL STENT SYSTEM/PRECISE RX NITINOL STENT SYSTEM/PRECISE PRO RX NITINOL STENT SYSTEM|NIM|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/03/2008|12/24/2008|||APPR|APPROVAL TO INCORPORATE AN ADDITIONAL PRECAUTION INTO THE INSTRUCTIONS FOR USE TO ADDRESS THE POTENTIAL FOR STENT FRACTURES THAT MAY OCCUR WITH SELF-EXPANDING STENTS SUCH AS THE CORDIS PRECISE STENT SYSTEMS.
P980022|S043|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CARELINK PERSONAL SOFTWARE|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/04/2008|01/27/2009|||APPR|APPROVAL FOR AN UPDATED VERSION OF THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES (MMT-7333) THAT CORRECTS PREVIOUSLY IDENTIFIED ANOMALIES.
P000012|S019|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2008|12/22/2008|||OK30|ELIMINATION OF REDUNDANT FUNCTIONAL TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.
P050028|S003|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2008|12/22/2008|||OK30|ELIMINATION OF REDUNDANT FUNCTIONAL TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.
P060030|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2008|12/22/2008|||OK30|ELIMINATION OF REDUNDANT FUNCTIONAL TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.
P000007|S020|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2008|12/31/2008|||OK30|ADDITION OF A SUPPLIER FOR PORCINE TISSUE.
P870056|S032|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CAEPENTIER EDWARDS PORCINE BIOPROSTHESIS & CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2008|12/31/2008|||OK30|ADDITION OF A SUPPLIER FOR PORCINE TISSUE.
P010041|S019|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2008|12/31/2008|||OK30|ADDITION OF A SUPPLIER FOR PORCINE TISSUE.
P870077|S031|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2008|12/31/2008|||OK30|ADDITION OF A SUPPLIER FOR PORCINE TISSUE.
P040047|S012|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2008|01/07/2009|||OK30|ADDITIONAL MIXING SYSTEM TO MANUFACTURE LARGER BATCHES OF THE DEVICE.
P050037|S016|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2008|01/06/2009|||OK30|CHANGE IN THE MIXING OPERATION FOR THE DEVICE.
P050052|S017|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2008|01/06/2009|||OK30|CHANGE IN THE MIXING OPERATION FOR THE DEVICE.
P040001|S012|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM|NQO|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/2009|01/28/2010|||APPR|APPROVAL FOR A LABELING CHANGE TO ADD PLACEMENT OF THE PATIENT IN THE PRONE POSITION DURING IMPLANTATION OF THE DEVICE.
P010013|S021|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|12/09/2008|02/04/2009|||APPR|APPROVAL FOR CHANGES TO THE RF CONTROLLER MACHINE LOGIC TO SIMPLIFY PROGRAMMING AND MINOR ERGONOMIC IMPROVEMENTS.
P040037|S013|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/09/2008|06/25/2009|||APPR|APPROVAL TO MODIFY THE DESIGN PLATFORM OF THE LARGE DIAMETER DEVICE (9-13MM DIAMETER) SO THAT IT IS IDENTICAL TO THE CURRENTLY APPROVED SMALLER DIAMETER DEVICES.  THE DESIGN PLATFORM MODIFICATION INCLUDES CHANGES TO THE DELIVERY SYSTEM AND ASSOCIATED MANUFACTURING CHANGES.
P000039|S027|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER, AND AMPLATZER ¿CRIBRIFORM¿ OCCLUDER|MAE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/09/2008|01/08/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING REGRADING ASPIRIN DOSING.
P040040|S007|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/09/2008|01/08/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING REGRADING ASPIRIN DOSING.
P960013|S041|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL ST LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2008|12/31/2008|||OK30|CHANGE TO ELIMINATE THE PLASMA PRIMING PROCESS.
P050037|S017|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/09/2008|02/03/2009|||APPR|APPROVAL FOR: 1. CHANGING THE FILL VOLUME FROM A MAXIMUM DELIVERABLE FILL VOLUME OF 1.3 CC TO A MAXIMUM DELIVERABLE FILL VOLUME OF 1.5 CC.2. CHANGING THE SYRINGE BARREL HANDLE FROM A MOLDED STRAIGHT HANDLE TO A MOLDED HANDLE WITH AN ERGONOMIC CURVED HANDLE.3. MODIFICATION TO THE INSTRUCTION FOR USE TO INCLUDE THE 1.5 CC FILL VOLUME IN THE DEVICEDESCRIPTION SECTION OF THE INSTRUCTIONS FOR USE.4. CREATION OF PACKAGE LABELING SPECIFIC TO THE 1.5 CC FILL VOLUME, IDENTICAL TO THE PACKAGE LABELING FOR THE 0.3 CC AND 1.3 CC FILL VOLUME PRODUCTS WITH THE EXCEPTION OF THE IDENTIFIED FILL VOLUME AND PART NUMBER.
P050052|S018|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/09/2008|02/03/2009|||APPR|APPROVAL FOR: 1. CHANGING THE FILL VOLUME FROM A MAXIMUM DELIVERABLE FILL VOLUME OF 1.3 CC TO A MAXIMUM DELIVERABLE FILL VOLUME OF 1.5 CC.2. CHANGING THE SYRINGE BARREL HANDLE FROM A MOLDED STRAIGHT HANDLE TO A MOLDED HANDLE WITH AN ERGONOMIC CURVED HANDLE.3. MODIFICATION TO THE INSTRUCTION FOR USE TO INCLUDE THE 1.5 CC FILL VOLUME IN THE DEVICEDESCRIPTION SECTION OF THE INSTRUCTIONS FOR USE.4. CREATION OF PACKAGE LABELING SPECIFIC TO THE 1.5 CC FILL VOLUME, IDENTICAL TO THE PACKAGE LABELING FOR THE 0.3 CC AND 1.3 CC FILL VOLUME PRODUCTS WITH THE EXCEPTION OF THE IDENTIFIED FILL VOLUME AND PART NUMBER.
P990019|S006|DUSA PHARMACEUTICALS, INC.|25 UPTON DR.||WILMINGTON|MA|01887||SYSTEM, LASER, PHOTODYNAMIC THERAPY|BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR|MVF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2008|01/09/2009|||OK30|USE OF AN UPDATED MODEL OF THE TIMER ASSEMBLY USED IN THE DEVICE.
P010012|S199|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/14/2009|||OK30|UPGRADING THE SOFTWARE FOR THE AUTOMATED VISION SYSTEM.
P960040|S186|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/14/2009|||OK30|UPGRADING THE SOFTWARE FOR THE AUTOMATED VISION SYSTEM.
P980035|S125|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG/KAPPA 400DR/SR/KAPPA 600/700/650/800/900/SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P010015|S058|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC CARDIAC RESYNCHRONIZATION THERAPY PACING (CRT-P) & INSYNC III CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P010031|S138|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC MARQUIS& MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/MAXIMO II CRT-D/CONCERTO CRT-D/CONSULTA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P890003|S159|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P970012|S049|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P980016|S171|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS ICD/MAXIMO/MAXIMO II/INTRINSIC/ENTRUST/VIRTUOSO/SECURA ICD FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P990001|S048|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA FAMILY/C-SERIES/T-SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P840001|S123|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC RESPORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/16/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONIC, INC., WINONA, MINNESOTA.
P920015|S051|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD/Y ADAPTORS/IS-1 PORT PIN PLUG/SPRINT LEAD/QUATTRO/QUATTRO SECURE/QUATTRO SINGLE COIL/TRANSVENE SVC/DF-1/Y ADAPTOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P830061|S044|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS/SP LEADS/CAPSURE SENSE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P060039|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P960009|S057|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA THERAPY FOR DBS|MHY|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/16/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONIC, INC., WINONA, MINNESOTA.
P010031|S139|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||ATTAIN SD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P970004|S065|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM|EZW|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/16/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONIC, INC., WINONA, MINNESOTA.
P850089|S060|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z NOVUS/CAPSURE Z/CAPSURE SP/ CAPSURE SP NOVUS LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P030036|S011|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P980016|S172|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P980050|S039|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CS-SVC TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P010015|S059|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN OTW/BIPOLAR OTW/CS/LV LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P950024|S015|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR/BIPOLAR LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P930039|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS/SUREFIX/CAPSUREFIX LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P900061|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P890003|S160|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|WRENCH KIT/SERVICE KIT/CAPSURE VDD LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2008|01/09/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P000006|S014|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS (IPP)|FHW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2008|05/29/2009|||APPR|APPROVAL FOR A CHANGE IN EQUIPMENT USED DURING THE MANUFACTURING DIPPING PROCESS FOR THE DEVICE.
P880091|S029|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2008|01/09/2009|||OK30|REPLACEMENT OF THE CURRENT FILTER USED DURING THE FILTERING PROCESS OF THE RMX-3 SILICONE BASE MATERIAL.
P930014|S029|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ TORIC INTRAOCULAR LENS (IOL)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/12/2008|02/05/2009|||APPR|APPROVAL FOR IOL MODELS SN6AT3, SN6AT4 AND SN6AT5. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ TORIC INTRAOCULAR LENSES AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OFAPHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION OF RESIDUAL REFRACTIVE CYLINDER AND INCREASED SPECTACLE INDEPENDENCE FOR DISTANCE VISION.
P060033|S026|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS/SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2008|03/20/2009|||APPR|APPROVAL FOR REMOVAL OF THE STENT SECUREMENT TEST AS A FINAL ACCEPTANCE ACTIVITY.
P030009|S030|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2008|12/31/2008|||OK30|CHANGE OF MARKER BAND MANUFACTURING SPECIFICATIONS.
P970021|S024|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE II|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|ADDITION OF A DUPLICATE QUALITY CONTROL TEST AND AN AUTOMATED TOOL USED IN THE MANUFACTURING PROCESS FOR THE DEVICE.
P040037|S014|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/09/2009|||OK30|MODIFICATION TO THE PROCESS FOR BONDING THE DISTAL CATHETER TIP.
P060008|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|REMOVAL OF THE REJECT CRITERIA FOR THE PROXIMAL WELD CREASE ON ALL PRODUCT SIZES.
P040038|S015|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/2008|07/23/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING TO INCLUDE THE POST-APPROVAL STUDY FINDINGS.
P990001|S049|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C/T SERIES/SELECTION/DIAMOND II/JADE II/RUBY II/TOPAZ II/VITA/VITA II/DEMA FAMILY OF IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P010015|S060|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P890003|S161|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P970012|S050|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P980035|S126|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/SIGMA/MEDTRONIC 350 IPG/ENPULSE/ADAPTA/VERSIA/SENSIA/RELIA FAMILIES OF IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P840001|S124|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.
P860004|S103|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED PUMP AND INFUSION SYSTEM||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.
P960009|S058|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA THERAPY FOR DBS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.
P970004|S066|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2008|01/14/2009|||OK30|REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.
P930027|S008|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS|MTF|IM|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2008|02/25/2010|||APPR|APPROVAL FOR IMMULITE 1000/2000/2500 PSA AND IMMULITE 1000/2000/2500 THIRD GENERATION PSA TO ADD AN ADDITIONAL ANTIBODY (MURINE MONOCLONAL ANTIBODY CONJUGATE: MAB 7F4), INCLUDE A PH TREATMENT TO THE CHICKEN SERUM AND REMOVAL OF THIMERASOL AS A PRESERVATIVE.
P000029|S053|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2008|01/09/2009|||OK30|CHANGE IN THE TEST METHOD FOR A RAW MATERIAL.
P970021|S025|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2008|02/11/2009|||APPR|APPROVAL FOR A MODIFIED TRI-Y, COMPONENT OF THE BALLOON CATHETER, AND A CHANGE TO THE RAW MATERIAL SPECIFICATION FOR THE PRESSURE TUBING.
P060033|S027|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMU-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2008|01/10/2009|||OK30|REDUCTION IN THE BUFFER SPRAY DISTANCE DURING THE STENT DRUG COASTING PROCESS FOR THE DEVICE.
P790017|S099|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2008|01/14/2009|||OK30|ADDITIONAL AUTOMATION OF THE BALLOON SUB-ASSEMBLY MANUFACTURING PROCESS.
P950020|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CORONARY CUTTING BALLOON|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2008|01/14/2009|||OK30|CHANGE TO THE VENDOR FOR THE OVER-THE-WIRE (OTW) MANIFOLD COMPONENT USED TO MANUFACTURE THE FLEXTOME CORONARY CUTTING BALLOON.
P970004|S067|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2008|01/05/2009|||OK30|INTRODUCTION OF SPRAY WASH EQUIPMENT AND THE MODIFICATION OF THE CLEANING PROCESS.
P960009|S059|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA THERAPY FOR DBS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2008|01/05/2009|||OK30|INTRODUCTION OF SPRAY WASH EQUIPMENT AND THE MODIFICATION OF THE CLEANING PROCESS.
P860057|S053|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2008|12/08/2009|||APPR|APPROVAL FOR HARMONIZING THE CENTRAL HOLE DIAMETER, HARMONIZING THE WIREFORM CUSP DIAMETER AND ADDING AORTIC COMMISSURE TIP ANGLE AND COMMISSURE TIP RADIUS INSPECTIONS.
P840001|S125|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL/SYNERGY/RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2008|01/05/2009|||OK30|INTRODUCTION OF SPRAY WASH EQUIPMENT AND THE MODIFICATION OF THE CLEANING PROCESS.
P040033|S010|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2008|02/13/2009|||APPR|APPROVAL FOR THE ADDITION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND REVISIONS TO THE SURGICAL TECHNIQUE.
P060027|S009|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT & SITUS OTW LV|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/17/2008|03/04/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020026|S059|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/2008|05/27/2011|||APPR|APPROVAL FOR THE XTEND MANUFACTURING PROCESS AND AN EXTENSION OF YOUR APPROVED SHELF LIFE FROM 3 TO 6 MONTHS.
P000008|S014|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|12/18/2008|01/16/2009|||APPR|APPROVAL FOR MODIFYING THE LABELING TO IDENTIFY THE ¿PARS FLACCIDA¿ TECHNIQUE AS THE RECOMMENDED TECHNIQUE TO USE DURING SURGICAL PLACEMENT OF THE DEVICE.
P860003|S051|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2008|01/16/2009|||OK30|TRANSFER OF THREE (3) UVAR XTS PHOTOPHERESIS PROCEDURAL KIT FINISHED PRODUCT QUALITY CONTROL TEST TO A CONTRACT TESTING LABORATORY.
P880086|S171|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ST JUDE MEDICAL AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2008|01/16/2009|||OK30|CHANGES TO THE CLEANING PROCESS USED FOR FEEDTHROUGH AND HYBRID CERAMIC SUBSTRATES AT THE COMPONENT VENDOR.
P030035|S050|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2008|01/16/2009|||OK30|CHANGES TO THE CLEANING PROCESS USED FOR FEEDTHROUGH AND HYBRID CERAMIC SUBSTRATES AT THE COMPONENT VENDOR.
P030050|S004|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/17/2008|08/17/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960009|S060|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY|MHY|NE|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|12/19/2008|11/25/2009|||APPR|APPROVAL FOR A LABELING UPDATE.
P050006|S009|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2008|01/10/2009|||OK30|CHANGE TO AN IN-PROCESS MANUFACTURING AID.
P020026|S060|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM /RAPTORAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2008|01/16/2009|||OK30|ADDITION OF AN ALTERNATE MANUFACTURING SITE FOR THE RAPTOR BALLOON COMPONENT.
P990040|S007|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2008|02/06/2009|||OK30|CHANGES AND MODIFICATIONS AS FOLLOWS: 1) THE TRANSFER OF THE MANUFACTURING OF THE TRUFILL N-BCA LIQUID EMBOLIC SYSTEM FROMONE BUILDING TO ANOTHER WITHIN THE SAME FACILITY;2) A CLARIFICATION OF THE INSTRUCTIONS FOR USE (1FU)THE REMOVAL OF A REDUNDANT INCOMING RECEIVING INSPECTION FOR THE N-BCA AND TANTALUMPOUCH;3) THE REMOVAL OF A SPECIFICATION FOR THE N-BCA AND TANTALUM POUCH; AND4) MODIFICATION OF THE SEAL SPECIFICATIONS FOR THE N-BCA AND TANTALUM POUCH.
P880086|S172|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ST JUDE MEDICAL AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2008|01/16/2009|||OK30|MODIFICATIONS TO THE MOISTURE GETTER DISPENSING SYSTEM.
P030035|S051|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2008|01/16/2009|||OK30|MODIFICATIONS TO THE MOISTURE GETTER DISPENSING SYSTEM.
P970051|S049|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2008|08/24/2009|||APPR|APPROVAL FOR THE FOLLOWING NEW COMPONENTS OF THE COCHLEAR IMPLANT SYSTEM: CP810 SOUND PROCESSOR, CR110 REMOTE ASSISTANT, CUSTOM SOUND 3.0 PROGRAMMING SOFTWARE.
P060040|S003|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LVAS|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/2008|01/08/2009|||APPR|APPROVAL FOR REVISED LABELING FOR THE HEARTMATE II LVAS REGARDING POTENTIAL DAMAGE TO THE PERCUTANEOUS LEAD RESULTING FROM WEAR AND FATIGUE.
P070027|S005|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2008|01/16/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM FOR STERILIZATION OF THE DEVICE.
P070007|S005|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2008|01/16/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM FOR STERILIZATION OF THE DEVICE.
P040012|S029|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK/RX ACCULINK CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2008|01/21/2009|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR MEASURING A COMPONENT SPECIFICATION.
P030009|S031|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2008|01/10/2009|||OK30|ADDITION OF AN ALTERNATIVE VENDOR FOR STENT RINGS.
P860057|S054|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/22/2008|02/20/2009|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE 3.8 OZ JAR PACKAGING SYSTEM USED FOR THE MODELS 7000 AND 7000TFX, CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESES AND A NEW NAME AND MODEL NUMBER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES MODELS 7100 AND 7100TFX AND ARE INDICATED FOR MITRAL VALVE REPLACEMENT.
P060033|S028|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2008|01/10/2009|||OK30|ADDITION OF AN ALTERNATIVE VENDOR FOR STENT RINGS.
P890003|S162|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|WRENCH & REPLACEMENT SETSCREW ACCESSORY KIT & ACCESSORY KIT|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2008|01/27/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CENTER, VILLALBA, PUERTO RICO.
P900061|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2008|01/27/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CENTER, VILLALBA, PUERTO RICO.
P990042|S008|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAX 3000 ANALYZER|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2008|01/14/2011|||APPR|APPROVAL FOR THE ETI-AB-AUK PLUS ASSAY ON THE ETI-MAX 3000 ANALYZER.
P030009|S032|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2008|01/16/2009|||OK30|ALTERNATE MANUFACTURING SITE FOR THE INNER CATHETER SUBASSEMBLY.
P060033|S029|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2008|01/16/2009|||OK30|ALTERNATE MANUFACTURING SITE FOR THE INNER CATHETER SUBASSEMBLY.
P830055|S107|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2008|02/22/2011|||APPR|APPROVAL TO MANUFACTURE THE SUBJECT COMPONENTS FROM GUR 1020 POLYETHYLENE WITH AN ANTIOXIDANT (AOX), TO CHANGE THE PACKAGING COMPONENTS AND MATERIALS, AND TO REQUEST APPROVAL OF A SHELF-LIFE TESTING PROTOCOL FOR THE SUBJECT P.F.C. SIGMA RP-F, LCS COMPLETE RP AND RPS TIBIAL INSERTS.
P030025|S062|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|12/23/2008|05/04/2012|||APPR|APPROVAL FOR REVISIONS TO THE DIRECTIONS FOR USE (DFU) TO INCORPORATED THE LATEST AVAILABLE CLINICAL FOLLOW-UP DATA.
P060008|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|05/07/2009|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION CHAMBER AT ISOTRON IRELAND, LTD.
P900009|S030|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 4000+ BONE HEALING SYSTEM|LPQ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|03/13/2009|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE MANUFACTURING OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).
P050042|S004|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|01/28/2009|||OK30|CHANGE TO THE LOT UNIFORMITY QUALITY CONTROL TEST METHOD.
P000058|S031|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBER TAPERED FUSION DEVICE|NEK|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|02/20/2009|||APPR|APPROVAL FOR CHANGES IN THE EXTERIOR CARTONS USED TO SHIP ONE OR MORE UNITS OF INFUSE BONE GRAFT.
P000039|S028|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|01/27/2009|||OK30|CHANGE IN SUPPLIER FOR A POLYESTER MENDING YARD.
P020024|S022|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|01/27/2009|||OK30|CHANGE IN SUPPLIER FOR A POLYESTER MENDING YARD.
P000054|S020|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|02/20/2009|||APPR|APPROVAL FOR CHANGES IN THE EXTERIOR CARTONS USED TO SHIP ONE OR MORE UNITS OF INFUSE BONE GRAFT.
P040040|S008|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|01/27/2009|||OK30|CHANGE IN SUPPLIER FOR A POLYESTER MENDING YARD.
P050053|S011|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2008|02/20/2009|||APPR|APPROVAL FOR CHANGES IN THE EXTERIOR CARTONS USED TO SHIP ONE OR MORE UNITS OF INFUSE BONE GRAFT.
P000010|S013|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2008|01/14/2009|||OK30|REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USE IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE AMPLICOR HCV TEST, VERSION 2, WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).
P050020|S009|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2008|03/06/2009|||OK30|CHANGES TO THE CLEAN ROOM ENVIRONMENTAL MONITORING PROGRAM CURRENTLY DESCRIBED IN DOC04098 FOR THE DEVICE.
P060040|S004|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/2008|12/04/2009|||APPR|APPROVAL FOR A NEW SEALED (GELWEAVE) OUTFLOW GRAFT WITH BEND RELIEF FOR USE WITH THE HEARTMATE II LVAS.
P980016|S173|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2008|02/13/2009|||APPR|APPROVAL FOR AN UPDATED TO THE APPROVED LEAD INTEGRITY ALERT (LIA) SOFTWARE APPLICATION MODEL SW01 WHICH CORRECTS AN UNINTENDED INTERACTION BETWEEN THE ENTRUST DR/VR ICDS AND LIA.
P000012|S020|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2008|01/14/2009|||OK30|CHANGE TO REVISE THE APPEARANCE SPECIFICATION FOR THE HCV PROBE SUSPENSION 2, VERSION 2.0 BULK.
P840001|S126|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTORE ADVANCED AND RECHARGEABLE MODELS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/2008|06/03/2009|||APPR|APPROVAL FOR MODEL 39565 SPECIFY 5-6-5 LEAD KIT (65CM LENGTH), MODEL 39286 SPECIFY 2X8 SURGICAL LEAD KIT (30CM AND 65CM LENGTHS), AND MODEL 3550-P4 PASSING ELEVATOR ACCESSORY KIT.
P050044|S008|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/2008|01/28/2009|||OK30|CHANGES IN INFRASTRUCTURE AS A PART OF AN ONGOING EXPANSION OF THE FIRM¿S MANUFACTURING CAPABILITIES.
P060038|S002|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX|LWR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/29/2008|02/27/2009|||APPR|APPROVAL FOR MANUFACTURING PROCESS IMPROVEMENTS TO THE AORTIC PERICARDIAL HEART VALVE MODEL 12.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDE THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P970008|S042|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2008|01/29/2009|||OK30|CHANGES INVOLVING A DISPOSABLE, SUBASSEMBLY COMPONENT OF THE DEVICE.
P040024|S032|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2008|01/27/2009|||OK30|CHANGE TO THE NEEDLE PACKAGED WITH RESTYLANE AND PERLANE INJECTABLE GELS.
P050018|S005|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2008|01/27/2009|||OK30|ALTERNATE SUPPLIER FOR THE SCORING ELEMENT.
P030054|S112|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/31/2008|01/15/2009|||APPR|APPROVAL OF THE MODEL 3330 VERSION 7.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030035|S052|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/31/2008|01/15/2009|||APPR|APPROVAL OF THE MODEL 3330 VERSION 7.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880006|S061|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/31/2008|01/15/2009|||APPR|APPROVAL OF THE MODEL 3330 VERSION 7.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880086|S173|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/31/2008|01/15/2009|||APPR|APPROVAL OF THE MODEL 3330 VERSION 7.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P910023|S198|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/31/2008|01/15/2009|||APPR|APPROVAL OF THE MODEL 3330 VERSION 7.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970013|S028|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/31/2008|01/15/2009|||APPR|APPROVAL OF THE MODEL 3330 VERSION 7.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970004|S068|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/02/2009|01/26/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.
P960009|S061|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF  NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/02/2009|01/26/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.
P840001|S127|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3/SYNERGY/RESTORE PRIME/PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/02/2009|01/26/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.
P030054|S113|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/02/2009|02/04/2009|||APPR|APPROVAL FOR THE CURRENT+ ICDS AND PROMOTE+ CRT-DS.
P020014|S022|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/02/2009|04/20/2009|||APPR|APPROVAL FOR CHANGES TO THE PHYSICIAN LABELING PRECAUTION REGARDING MAGNETIC RESONANCE IMAGING OF WOMEN WITH ESSURE MICRO-INSERTS.
P910023|S199|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/02/2009|02/04/2009|||APPR|APPROVAL FOR THE CURRENT+ ICDS AND PROMOTE+ CRT-DS.
P060025|S003|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|ATS 3F AORTIC BIOPROSTHESIS MODEL 1000|LWR|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/05/2009|03/05/2009|||APPR|APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE ATS 3F AORTIC BIOPROSTHESIS, MODEL 1000 VALVES (SIZES 19, 21, 23, 25, 27 AND 29 MM) FROM 2 YEARS TO 5 YEARS.  THE DEVICE IS INDICATED FOR ¿..USE IN PATIENTS WHOSE AORTIC VALVULAR DISEASE IS SUFFICIENTLY ADVANCED TO WARRANT REPLACEMENT OF THEIR VALVE WITH A PROSTHETIC DEVICE.  THE USUAL CONDITIONS OF ADVANCED DISEASE INCLUDE AORTIC STENOSIS, AORTIC INCOMPETENCE, AND A COMBINATION OF THE TWO.¿
P930014|S030|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2009|01/30/2009|||OK30|ELIMINATION OF PLASTIC WAFER TRANSPORT TRAYS FROM ONE STEP TO ANOTHER DURING PRODUCTION AND CONSOLIDATING THREE MANUAL SUB-PROCESS STEPS INTO A MANUFACTURING CELL.
P050047|S006|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2009|02/06/2009|||OK30|CHANGE IN MIXING CARTRIDGES.
P880031|S016|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON D SODIUM HYALURONATE SOLUTION|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/08/2009|02/18/2009|||APPR|APPROVAL TO CHANGE THE PH PRODUCT SPECIFICATION RANGE FOR HEALON D FROM 7.1 ¿ 7.5 TO 6.8 ¿ 7.6.
P060035|S001|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/2009|06/23/2009|||APPR|APPROVAL FOR MIGRATION OF THE ARCHITECT CORE-M ASSAY TO A NEW ARCHITECT  I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR.
P010032|S028|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI IPG NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2009|03/19/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO, LLC, IN CAGUAS, PUERTO RICO.
P020014|S023|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2009|03/09/2009|||APPR|APPROVAL OF MINOR CHANGES TO THE PATIENT INFORMATION BOOKLET.
P930021|S012|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|STRAUMANN EMDOGAIN|NQA|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2009|08/21/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT IBA STERIGENICS WALLONIE, S.A., IN VERVIERS, BELGIUM, FOR THE CONTRACT STERILIZATION OF THE DEVICE.
P820003|S088|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 5441 EPG PLASTIC COVER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2009|02/11/2009|||OK30|TRANSFERRING OF THE FINAL IN-PROCESS INSPECTION AND FINAL PACKAGE PROCESS STEPS FROM MEDTRONIC RICE CREEK FACILITY TO THE CONTRACT MANUFACTURER.
P050047|S007|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2009|07/07/2009|||APPR|APPROVAL FOR A CHANGE IN THE RELEASE OF PRODUCT.
P860004|S104|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/2009|03/13/2009|||APPR|APPROVAL FOR UPDATED MRI WARNING, CHANGES TO THE NEEDLE HUB, AND CHANGES TO THE Y-CONNECTOR FOR THE DRUG REFILL KITS.
P060010|S003|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE|NZC|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/2009|03/10/2009|||APPR|APPROVAL TO ADD 45 DEGREE CURVE IN THE DISTAL PORTION OF THE STENT.
P040001|S013|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/09/2009|03/11/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980016|S174|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO/MAXIMO II/SECURA/MARQUIS/INSTRINSIC 35J ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2009|02/10/2009|||OK30|MODIFICATIONS TO THE OUTLIER CRITERIA FOR THE OPEN CIRCUIT VOLTAGE (OCV) TEST.
P010031|S140|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||MAXIMO II CRT-D/CONCERTO ICD/CONSULTA CRT-D/INSYNC III MARQUIS/PROTECT/INSYNC SENTRY ICD/CONCERTO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2009|02/10/2009|||OK30|MODIFICATIONS TO THE OUTLIER CRITERIA FOR THE OPEN CIRCUIT VOLTAGE (OCV) TEST.
P020004|S041|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/14/2009|02/26/2009|||APPR|APPROVAL FOR A CHANGE TO THE MATERIAL AND SPECIFICATION OF THE DELIVERY SYSTEM DEPLOYMENT LINE.
P970004|S069|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/14/2009|01/14/2010|||APPR|APPROVAL FOR MATERIAL GRADE CHANGE TO THE MODEL 3550-05 TEMPORARY PERCUTANEOUS EXTENSION ETFE MATERIAL.
P070015|S010|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/14/2009|03/11/2009|||APPR|APPROVAL FOR A 24-MONTH SHELF LIFE.
P050052|S019|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/2009|07/13/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILED INSTRUCTIONS FOR MIXING RADIESSE WITH 2% LIDOCAINE HCL (RESULTING IN A FINAL CONCENTRATION OF 0.3% LIDOCAINE) PRIOR TO INJECTION FOR THE INDICATED USE OF SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS.  THE MIXING OF RADIESSE AND LIDOCAINE IS TO BE ACCOMPLISHED USING A MIXING KIT THAT WILL BE MADE AVAILABLE SEPARATE FROM THE RADIESSE DEVICE.
P080004|S001|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|ISPHERIC MODEL YA-60BB INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/2009|08/07/2009|||APPR|APPROVAL TO ADD A NEW PACKAGING CONFIGURATION WHEREIN THE HOYA SURGICAL OPTICS INTRAOCULAR LENSES (IOLS) WILL BE PACKAGED IN A DISPOSABLE, PLASTIC INJECTOR.
P950022|S055|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|SJM DURATA, RIATA ST OPTIM & RIATA ST FAMILIES OF DEFIBRILLATION LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2009|06/18/2009|||APPR|APPROVAL OF AN AUTOMATED HEAT SHRINKING PROCESS.
P010012|S200|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL, RENEWAL RF, RENEWAL ZODIAC, FRONTIER AND LIVIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2009|02/13/2009|||OK30|NEW LASER MARKING EQUIPMENT TO INCREASE PRODUCTION CAPACITY.
P960040|S187|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT, FRONTIER, AND VITALITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2009|02/13/2009|||OK30|NEW LASER MARKING EQUIPMENT TO INCREASE PRODUCTION CAPACITY.
P880091|S030|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2008|02/13/2009|||OK30|INSTALLATION OF A NEW COLLIMATOR ON THE AUTOMETRONICS OBV-750 OPTICAL BENCH.
P040024|S033|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE  INJECTABLE GELS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2009|02/12/2009|||OK30|ELIMINATION OF THE FINAL FUNCTIONAL AUDITS FOR THE DEVICES.
P980024|S003|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2009|02/10/2009|||OK30|CHANGE TO SCALE UP THE PRODUCTION OF CELL PASTE USED TO PREPARE PROBES TO REDUCE MANUFACTURING TIME.
P070027|S006|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|THE TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2009|03/13/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC VASCULAR GALWAY LIMITED, GALWAY, IRELAND.
P010020|S012|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2009|02/13/2009|||OK30|CHANGE TO AN IN-PROCESS PACKAGING SEAL TEST FOR TRAYS AND POUCHES FOR THE DEVICE.
P000053|S020|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2009|02/13/2009|||OK30|CHANGE TO AN IN-PROCESS PACKAGING SEAL TEST FOR TRAYS AND POUCHES FOR THE DEVICE.
P030006|S021|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2009|06/19/2009|||APPR|APPROVAL FOR MODIFICATION TO THE WELDING PROCESS THAT IS USED TO BOND THE CATHETER TIP TO THE CATHETER EXTRUSION FOR THE PROLIEVE TREATMENT CATHETER.
P860019|S231|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK OTW/MAVERICK 2  MONORAIL PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2009|02/19/2009|||OK30|ELIMINATION OF THE FINAL FUNCTIONAL AUDITS FOR THE DEVICES.
P010031|S141|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2009|03/11/2009|||APPR|APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES:1) TWO (2) IC DESIGN CHANGES¿ L310 AND L3542) TWO (2) ALTERNATE COMPONENTS¿ DIODE CHANGE (CURRENTLY: XD423 AND PROPOSED: XD445)¿ INSULATED-GATE BIPOLAR TRANSISTOR (IGBT) CHANGE (CURRENTLY: XD405 ANDPROPOSED: XD447)3) PRINTED WIRE BOARD (PWB) CHANGES TO ACCOMMODATE THE ALTERNATE (XD445 DIODE ANDXD447 IGBT) COMPONENTS AND MANUFACTURABILITY IMPROVEMENTS.4) FOUR (4) ICS (L303, L310, L354, AND L409) TO BE TRANSFERRED TO AN ALTERNATIVE ICFABRICATION VENDOR.
P980016|S175|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2009|03/11/2009|||APPR|APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES:1) TWO (2) IC DESIGN CHANGES¿ L310 AND L3542) TWO (2) ALTERNATE COMPONENTS¿ DIODE CHANGE (CURRENTLY: XD423 AND PROPOSED: XD445)¿ INSULATED-GATE BIPOLAR TRANSISTOR (IGBT) CHANGE (CURRENTLY: XD405 ANDPROPOSED: XD447)3) PRINTED WIRE BOARD (PWB) CHANGES TO ACCOMMODATE THE ALTERNATE (XD445 DIODE ANDXD447 IGBT) COMPONENTS AND MANUFACTURABILITY IMPROVEMENTS.4) FOUR (4) ICS (L303, L310, L354, AND L409) TO BE TRANSFERRED TO AN ALTERNATIVE ICFABRICATION VENDOR.
P000025|S039|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COCHLEAR IMPLANT SYSTEMS|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/18/2009|04/30/2009|||APPR|APPROVAL FOR CHANGES MADE TO THE FOLLOWING USER MANUALS: DIB II (DIAGNOSTIC INTERFACE BOX), OPUS 1, OPUS 2 AND TEMPO+ SPEECH PROCESSORS, RBP (REMOTE BATTERY PACK) AND MICROPHONE TEST DEVICE (MTD).
P070015|S011|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2009|02/11/2009|||OK30|INCREASE OF THE RETESTING INTERVAL FOR PURIFIED POLY(N-BUTYL METHACRYLATE).
P980043|S018|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/21/2009|04/08/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE CINCH VALVE HOLDER DOCUMENTS.
P990064|S026|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/21/2009|04/08/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE CINCH VALVE HOLDER DOCUMENTS.
P950022|S056|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST OPTIM/DURATA LEADS|LWS|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/21/2009|05/07/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030054|S114|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS II+ HF CRT-D & PROMOTE HE CRT-D|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/21/2009|05/07/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910023|S200|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|SJM MODEL 3510 PROGRAMMER(FOR ATLAS II CRT-D)/MERLIN MODEL 3650 PROGRAMMER( FOR ATLAS II & PROMOTE CRT-D)|NVZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/21/2009|05/07/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040002|S023|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2009|02/20/2009|||APPR|APPROVAL TO MOVE THE 34MM ACCESSORIES OVER TO INTUITRAK DELIVERY SYSTEM LINE AS WELL AS MAKING A STAND ALONE VERSION OF THE 34MM BIFURCATED BODY DELIVERY SHEATH AVAILABLE.
P030035|S053|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/22/2009|07/15/2009|||APPR|APPROVAL FOR THE ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS.  THE DEVICE IS INDICATED FOR: 1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONEAN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.  2) THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS IIIOR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRSDURATION. IMPLANTATION OF ACCENT, ACCENT RF, ANTHEM AND ANTHEM RF DEVICES IS INDICATED IN ONE OR MORE OF THE FOLLOWING PERMANENT CONDITIONS:A) SYNCOPEB) PRESYNCOPEC) FATIGUED) DISORIENTATION DUE TO ARRHYTHMIA/ BRADYCARDIAE) OR COMBINATION OF THOSE SYMPTOMS.RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.DUAL-CHAMBER PACING (ACCENT MODEL PM2110, ACCENT RF MODEL PM2210, ANTHEM AND ANTHEM RF DEVICES ONLY) IS INDICATED FOR THOSE PATIENTS EXHIBITING:A) SICK SINUS SYNDROMEB) CHRONIC, SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCKC) RECURRENT ADAMS-STOKES SYNDROMED) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSESHAVE BEEN RULED OUT.ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV ANDINTRAVENTRICULAR CONDUCTION SYSTEMS.VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND:A) NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARRESTB) CHRONIC ATRIAL FIBRILLATIONC) SEVERE PHYSICAL DISABILITY....(SEE APPROVAL ORDER FOR ADDITIONAL APPROVAL INFORMATION)
P880086|S174|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/22/2009|07/15/2009|||APPR|APPROVAL FOR THE ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCENT / ACCENT RF IMPLANTABLE PULSE GENERATORS AND ANTHEM / ANTHEM RF CRT-PS.  THE DEVICE IS INDICATED FOR: 1) MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONEAN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.  2) THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS IIIOR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRSDURATION. IMPLANTATION OF ACCENT, ACCENT RF, ANTHEM AND ANTHEM RF DEVICES IS INDICATED IN ONE OR MORE OF THE FOLLOWING PERMANENT CONDITIONS:A) SYNCOPEB) PRESYNCOPEC) FATIGUED) DISORIENTATION DUE TO ARRHYTHMIA/ BRADYCARDIAE) OR COMBINATION OF THOSE SYMPTOMS.RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.DUAL-CHAMBER PACING (ACCENT MODEL PM2110, ACCENT RF MODEL PM2210, ANTHEM AND ANTHEM RF DEVICES ONLY) IS INDICATED FOR THOSE PATIENTS EXHIBITING:A) SICK SINUS SYNDROMEB) CHRONIC, SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCKC) RECURRENT ADAMS-STOKES SYNDROMED) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSESHAVE BEEN RULED OUT.ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV ANDINTRAVENTRICULAR CONDUCTION SYSTEMS.VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND:A) NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARRESTB) CHRONIC ATRIAL FIBRILLATIONC) SEVERE PHYSICAL DISABILITY....(SEE APPROVAL ORDER FOR ADDITIONAL APPROVAL INFORMATION)
P050023|S020|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS|MRM|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/26/2009|05/12/2009|||APPR|APPROVAL FOR MODIFICATION OF PRODUCT LABELING FOR DEVICES THAT UTILIZE HOME MONITORING. SPECIFICALLY, SUPPLEMENTS REQUESTED APPROVAL FOR THE REPLACEMENT OF EXISTINGPRECAUTIONS AND THE FOLLOWING MARKETING STATEMENTS:1) BIOTRONIC HOME MONITORING INFORMATION MAY BE USED AS A REPLACEMENT FORDEVICE INTERROGATION DURING IN-OFFICE FOLLOW-UP VISITS.2) A STRATEGY OF CARE USING BIOTRONIK HOME MONITORING WITH OFFICE VISITS WHEN NEEDED - HAS BEEN SHOWN TO EXTEND THE LIME BETWEEN ROUTINE, SCHEDULED IN-OFFICEFOLLOW-UPS OF BIOTRONIK IMPLANTABLE DEVICES IN MANY PATIENTS. HOME MONITORING DATA IS HELPFUL IN DETERMINING THE NEED FOR ADDITIONAL IN-OFFICE FOLLOW-UP.3) BIOTRONIK HOME MONITORING PATIENTS -WHO ARE FOLLOWED REMOTELY WITH OFFICEVISITS WHEN NEEDED - HAVE BEEN SHOWN TO HAVE SIMILAR NUMBERS OF STROKES, INVASIVE PROCEDURES AND DEATHS AS PATIENTS FOLLOWED WITH CONVENTIONAL IN-OFFICE FOLLOW-UPS.4) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF ARRHYTHMIAS.5) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF SILENT, ASYMPTOMATIC ARRHYTHMIAS.6) AUTOMATIC EARLY DETECTION OF ARRHYTHMIAS AND DEVICE SYSTEM ANOMALIES BYBIOTRONIK HOME MONITORING ALLOWS FOR EARLIER INTERVENTION THAN CONVENTIONAL IN-OFFICEFOLLOW-UPS.7) BIOTRONIK HOME MONITORING ALLOWS FOR IMPROVED ACCESS TO PATIENT DEVICE DATA COMPARED TO CONVENTIONAL IN-OFFICE FOLLOW-UPS SINCE DEVICE INTERROGATION IS AUTOMATICALLYSCHEDULED AT REGULAR INTERVALS.
P950037|S068|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS II DR-T|NVZ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/26/2009|05/12/2009|||APPR|APPROVAL FOR MODIFICATION OF PRODUCT LABELING FOR DEVICES THAT UTILIZE HOME MONITORING. SPECIFICALLY, SUPPLEMENTS REQUESTED APPROVAL FOR THE REPLACEMENT OF EXISTINGPRECAUTIONS AND THE FOLLOWING MARKETING STATEMENTS:1) BIOTRONIC HOME MONITORING INFORMATION MAY BE USED AS A REPLACEMENT FORDEVICE INTERROGATION DURING IN-OFFICE FOLLOW-UP VISITS.2) A STRATEGY OF CARE USING BIOTRONIK HOME MONITORING WITH OFFICE VISITS WHEN NEEDED - HAS BEEN SHOWN TO EXTEND THE LIME BETWEEN ROUTINE, SCHEDULED IN-OFFICEFOLLOW-UPS OF BIOTRONIK IMPLANTABLE DEVICES IN MANY PATIENTS. HOME MONITORING DATA IS HELPFUL IN DETERMINING THE NEED FOR ADDITIONAL IN-OFFICE FOLLOW-UP.3) BIOTRONIK HOME MONITORING PATIENTS -WHO ARE FOLLOWED REMOTELY WITH OFFICEVISITS WHEN NEEDED - HAVE BEEN SHOWN TO HAVE SIMILAR NUMBERS OF STROKES, INVASIVE PROCEDURES AND DEATHS AS PATIENTS FOLLOWED WITH CONVENTIONAL IN-OFFICE FOLLOW-UPS.4) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF ARRHYTHMIAS.5) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF SILENT, ASYMPTOMATIC ARRHYTHMIAS.6) AUTOMATIC EARLY DETECTION OF ARRHYTHMIAS AND DEVICE SYSTEM ANOMALIES BYBIOTRONIK HOME MONITORING ALLOWS FOR EARLIER INTERVENTION THAN CONVENTIONAL IN-OFFICEFOLLOW-UPS.7) BIOTRONIK HOME MONITORING ALLOWS FOR IMPROVED ACCESS TO PATIENT DEVICE DATA COMPARED TO CONVENTIONAL IN-OFFICE FOLLOW-UPS SINCE DEVICE INTERROGATION IS AUTOMATICALLYSCHEDULED AT REGULAR INTERVALS.
P030052|S003|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2009|02/25/2009|||OK30|CHANGE TO SCALE UP THE PRODUCTION OF CELL PASTE USED TO PREPARE PROBES TO REDUCE MANUFACTURING TIME.
P000009|S033|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMOS DR-T AND LUMOS VR-T|MRM|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/26/2009|05/12/2009|||APPR|APPROVAL FOR MODIFICATION OF PRODUCT LABELING FOR DEVICES THAT UTILIZE HOME MONITORING. SPECIFICALLY, SUPPLEMENTS REQUESTED APPROVAL FOR THE REPLACEMENT OF EXISTINGPRECAUTIONS AND THE FOLLOWING MARKETING STATEMENTS:1) BIOTRONIC HOME MONITORING INFORMATION MAY BE USED AS A REPLACEMENT FORDEVICE INTERROGATION DURING IN-OFFICE FOLLOW-UP VISITS.2) A STRATEGY OF CARE USING BIOTRONIK HOME MONITORING WITH OFFICE VISITS WHEN NEEDED - HAS BEEN SHOWN TO EXTEND THE LIME BETWEEN ROUTINE, SCHEDULED IN-OFFICEFOLLOW-UPS OF BIOTRONIK IMPLANTABLE DEVICES IN MANY PATIENTS. HOME MONITORING DATA IS HELPFUL IN DETERMINING THE NEED FOR ADDITIONAL IN-OFFICE FOLLOW-UP.3) BIOTRONIK HOME MONITORING PATIENTS -WHO ARE FOLLOWED REMOTELY WITH OFFICEVISITS WHEN NEEDED - HAVE BEEN SHOWN TO HAVE SIMILAR NUMBERS OF STROKES, INVASIVE PROCEDURES AND DEATHS AS PATIENTS FOLLOWED WITH CONVENTIONAL IN-OFFICE FOLLOW-UPS.4) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF ARRHYTHMIAS.5) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF SILENT, ASYMPTOMATIC ARRHYTHMIAS.6) AUTOMATIC EARLY DETECTION OF ARRHYTHMIAS AND DEVICE SYSTEM ANOMALIES BYBIOTRONIK HOME MONITORING ALLOWS FOR EARLIER INTERVENTION THAN CONVENTIONAL IN-OFFICEFOLLOW-UPS.7) BIOTRONIK HOME MONITORING ALLOWS FOR IMPROVED ACCESS TO PATIENT DEVICE DATA COMPARED TO CONVENTIONAL IN-OFFICE FOLLOW-UPS SINCE DEVICE INTERROGATION IS AUTOMATICALLYSCHEDULED AT REGULAR INTERVALS.
P070008|S009|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV-T|NKE|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/26/2009|05/12/2009|||APPR|APPROVAL FOR MODIFICATION OF PRODUCT LABELING FOR DEVICES THAT UTILIZE HOME MONITORING. SPECIFICALLY, SUPPLEMENTS REQUESTED APPROVAL FOR THE REPLACEMENT OF EXISTINGPRECAUTIONS AND THE FOLLOWING MARKETING STATEMENTS:1) BIOTRONIC HOME MONITORING INFORMATION MAY BE USED AS A REPLACEMENT FORDEVICE INTERROGATION DURING IN-OFFICE FOLLOW-UP VISITS.2) A STRATEGY OF CARE USING BIOTRONIK HOME MONITORING WITH OFFICE VISITS WHEN NEEDED - HAS BEEN SHOWN TO EXTEND THE LIME BETWEEN ROUTINE, SCHEDULED IN-OFFICEFOLLOW-UPS OF BIOTRONIK IMPLANTABLE DEVICES IN MANY PATIENTS. HOME MONITORING DATA IS HELPFUL IN DETERMINING THE NEED FOR ADDITIONAL IN-OFFICE FOLLOW-UP.3) BIOTRONIK HOME MONITORING PATIENTS -WHO ARE FOLLOWED REMOTELY WITH OFFICEVISITS WHEN NEEDED - HAVE BEEN SHOWN TO HAVE SIMILAR NUMBERS OF STROKES, INVASIVE PROCEDURES AND DEATHS AS PATIENTS FOLLOWED WITH CONVENTIONAL IN-OFFICE FOLLOW-UPS.4) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF ARRHYTHMIAS.5) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF SILENT, ASYMPTOMATIC ARRHYTHMIAS.6) AUTOMATIC EARLY DETECTION OF ARRHYTHMIAS AND DEVICE SYSTEM ANOMALIES BYBIOTRONIK HOME MONITORING ALLOWS FOR EARLIER INTERVENTION THAN CONVENTIONAL IN-OFFICEFOLLOW-UPS.7) BIOTRONIK HOME MONITORING ALLOWS FOR IMPROVED ACCESS TO PATIENT DEVICE DATA COMPARED TO CONVENTIONAL IN-OFFICE FOLLOW-UPS SINCE DEVICE INTERROGATION IS AUTOMATICALLYSCHEDULED AT REGULAR INTERVALS.
P970003|S105|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY PULSE MODEL 102 & PULSE DUO MODEL 102R GENERATOR|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2009|02/23/2009|||OK30|APPROVAL TO ADD AN ADDITIONAL AUTOMATED ELECTRICAL TEST TO THE MANUFACTURING PROCESS.
P020004|S042|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2009|02/18/2009|||OK30|MODIFICATIONS TO THE LIMULUS AMEBOCYTE LYSATE (LAL) SAMPLING PLAN TO ALLOW FOR TESTING OF THREE DEVICES FROM THE TWO APPROVED MANUFACTURING FACILITIES IN ONE POOLED ELUTION BATCH.
P980016|S176|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2009|02/25/2009|||OK30|CHANGE TO THE FINAL DEVICE TEST USED ON MULTIPLE PRODUCT FAMILIES.
P010031|S142|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2009|02/25/2009|||OK30|CHANGE TO THE FINAL DEVICE TEST USED ON MULTIPLE PRODUCT FAMILIES.
P790017|S100|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|NC SPRINTER RAPID EXCHANGE BALLOON DILATATION CATHETER|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2009|03/12/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO, IN TIJUANA MEXICO.
P980037|S028|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2009|02/24/2009|||OK30|ALTERNATE PROCESS CHALLENGE DEVICE (PCD) BIOLOGICAL INDICATOR (BI) TO MONITOR THE ETHYLENE OXIDE STERILIZATION PROCESS.
P030002|S018|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|NAA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2009|02/26/2009|||OK30|IMPLEMENTATION OF AN ALTERNATE COMPONENT CLEANING METHOD.
P830055|S108|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2009|11/09/2009|||APPR|APPROVAL FOR A CHANGE TO AN AUTOMATED CONE POLISHING PROCESS FOR THE MBT TIBIAL TRAYS.
P080007|S001|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|E-LUMINEXX VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2009|02/26/2009|||OK30|MODIFICATIONS TO THE MANUFACTURING PROCESS FOR A DELIVERY SYSTEM COMPONENT.
P950029|S040|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY SR 2250, SYMPHONY DR 2550, RHAPSODY SR 2210, RHAPSODY DR 2510, RHAPSODY DR 2530, REPLY ST & REPLY DR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2009|02/23/2009|||OK30|CHANGE IN THE TYPE OF X-RAY MACHINE.
P980049|S045|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2009|02/23/2009|||OK30|CHANGE IN THE TYPE OF X-RAY MACHINE.
P060027|S010|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2009|02/23/2009|||OK30|CHANGE IN THE TYPE OF X-RAY MACHINE.
P050042|S005|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL|MZO|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/28/2009|06/23/2009|||APPR|APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT ANTI-HCV ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.
P080010|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|Normal 180 Day Track||N|01/27/2009|06/12/2009|||APPR|APPROVAL FOR CHANGES TO THE LABELING FOR THE TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODELS ZM900 AND ZMA00, REVISION THE DIRECTIONS FOR USE (DFU) AND THE PATIENT BROCHURE FOR THE LENS MODELS WITH UPDATED ONE-YEAR FOLLOW UP DATA FROM THE CLINICAL INVESTIGATION FOR THE LENSES.
P950021|S009|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ADVIA CENTAUR PSA & ADVIA CENTAUR CP PSA IMMUNOASSAY|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2009|12/03/2009|||APPR|APPROVAL FOR THE CHANGE IN ANTIBODY GROWTH MANUFACTURING PROCESS FROM ASCITES FLUID TO CELL CULTURE.
P050037|S018|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2009|02/25/2009|||APPR|APPROVAL FOR THE ADDITION OF A 0.8 CC FILL VOLUME INJECTABLE IMPLANT AND ASSOCIATED LABELING CHANGES.
P050052|S020|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2009|02/25/2009|||APPR|APPROVAL FOR THE ADDITION OF A 0.8 CC FILL VOLUME INJECTABLE IMPLANT AND ASSOCIATED LABELING CHANGES.
P990041|S010|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2009|02/25/2009|||OK30|APPROVAL TO MOVE THE MANUFACTURING OF THE RECOMBINANT HBEAG FROM A SUPPLIER TO INSIDE DIASORIN AND TO REVISE THE QC PROCEDURE FOR PURIFIED R-HBE AG RAW MATERIAL ACCEPTANCE.
P990043|S011|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2009|02/25/2009|||OK30|APPROVAL TO MOVE THE MANUFACTURING OF THE RECOMBINANT HBEAG FROM A SUPPLIER TO INSIDE DIASORIN AND TO REVISE THE QC PROCEDURE FOR PURIFIED R-HBE AG RAW MATERIAL ACCEPTANCE.
P060033|S031|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2009|07/13/2009|||APPR|APPROVAL FOR CHANGES TO THE PATIENT GUIDE.
P020014|S024|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM|HHS|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2009|08/26/2009|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE WOUND INNER/OUTER COIL (PRECISION WIRE COMPONENTS) OF THE DEVICE.
P990074|S021|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|ALLERGAN SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2009|03/03/2009|||OK30|CHANGE IN THE SUPPLIER OF COMPONENTS FOR THE MANUFACTURE OF THE DEVICE.
P020056|S010|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|ALLERGAN NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2009|02/27/2009|||OK30|CHANGE IN THE SUPPLIER OF COMPONENTS FOR THE MANUFACTURE OF THE DEVICE.
P060007|S002|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/30/2009|07/13/2009|||APPR|APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT HBSAG/ ARCHITECT HBSAG CONFIRMATORY ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/I2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.
P950022|S057|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA/RIATA ST & DURATA FAMILIES OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2009|02/27/2009|||OK30|ADDITION OF AN ALTERNATE SEMI-AUTOMATED PACKAGING PROCESS.
P960013|S042|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL/TENDRIL ST & OPTISENSE FAMILIES OF LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2009|02/27/2009|||OK30|ADDITION OF AN ALTERNATE SEMI-AUTOMATED PACKAGING PROCESS.
P960030|S025|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS/ISOFLEX S&P/ISOFELX OPTIM FAMILIES OF LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2009|02/27/2009|||OK30|ADDITION OF AN ALTERNATE SEMI-AUTOMATED PACKAGING PROCESS.
P030035|S054|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|AESCULA FAMILY OF LEFT HEART LEADS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2009|02/27/2009|||OK30|ADDITION OF AN ALTERNATE SEMI-AUTOMATED PACKAGING PROCESS.
P030054|S115|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE & QUICKFLEX FAMILIES OF LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2009|02/27/2009|||OK30|ADDITION OF AN ALTERNATE SEMI-AUTOMATED PACKAGING PROCESS.
P810006|S032|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|03/26/2009|||APPR|APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES.
P850010|S029|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|03/26/2009|||APPR|APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES.
P840062|S018|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING|LPG|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|03/26/2009|||APPR|APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES.
P980035|S127|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENIA/RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|03/03/2009|||OK30|CHANGES TO THE TEST SOFTWARE AND HARDWARE FOR THE FINAL FUNCTIONAL TEST.
P060002|S004|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|03/03/2009|||OK30|MOVEMENT OF A MANUFACTURING PROCESS WITHIN THE BARD CAMPUS.
P070015|S012|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|03/02/2009|||OK30|MODIFICATION TO CYCLOHEXANONE TEST METHODS.
P040024|S034|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE AND PERLANE INJECTABLE GELS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|03/04/2009|||OK30|CHANGE IN CLEANING PROCEDURE IN CONJUNCTION WITH THE MANUFACTURING OF THE DEVICE.
P020018|S031|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/2009|02/24/2009|||APPR|APPROVAL FOR MODIFYING THE PRODUCT LABELING TO CLARIFY REMOVAL OF THE TRIGGER WIRE.
P040037|S015|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|02/26/2009|||OK30|CHANGES TO THE PACKAGING COMPONENT FOR THE DEVICE.
P040037|S016|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|02/13/2009|||OK30|ADDITIONAL PACKAGING LOCATIONS WITHIN THE SAME COMPLEX OF BUILDINGS.
P050006|S010|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|02/13/2009|||OK30|ADDITIONAL PACKAGING LOCATIONS WITHIN THE SAME COMPLEX OF BUILDINGS.
P040043|S027|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|02/13/2009|||OK30|ADDITIONAL PACKAGING LOCATIONS WITHIN THE SAME COMPLEX OF BUILDINGS.
P020004|S043|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|02/13/2009|||OK30|ADDITIONAL PACKAGING LOCATIONS WITHIN THE SAME COMPLEX OF BUILDINGS.
P040027|S013|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2009|02/13/2009|||OK30|ADDITIONAL PACKAGING LOCATIONS WITHIN THE SAME COMPLEX OF BUILDINGS.
P050020|S010|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/2009|09/25/2009|||APPR|APPROVAL NEW PACKAGING AND DESICCANT FOR THE INSERTER SUBCOMPONENT OF THE SENSOR DELIVERY UNIT (SDU), WHICH IS A COMPONENT OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS MODIFICATION TO THE ORIGINAL APPROVED DEVICE RESULTS IN A NEWSTERILIZATION CONFIGURATION, A NEW PACKAGE AND NEW STERILIZATION METHOD (EO) FOR THE SENSORSUPPORT MOUNT SUBCOMPONENT OF THE SDU, USER ASSEMBLY OF THE INSERTER WITH THE SENSOR SUPPORTMOUNT SECTION, NEW SECONDARY CONTAINERS FOR THE SUBCOMPONENTS OF THE SDU SECTION, AND CHANGES TO SDU LABELING CORRESPONDING TO THE PACKAGING CHANGES.
P980022|S046|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK REAL-TIME TRANSMITTER & CGMS IPRO DIGITAL RECORDER|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/2009|06/19/2009|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE MINILINK REAL-TIME TRANSMITTER & CGMS IPRO DIGITAL RECORDER: ADDITION OF A SHELF MODE, BATTERY UNDER VOLTAGE PROTECTION, ELECTROSTATIC DISCHARGE (ESD) PROTECTION, REMOVAL OF THE DISCONNECT TEST, AND A NEW HOUSING.
P000044|S020|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/2009|10/23/2009|||APPR|APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600 INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE VITROS HBSAG ASSAY AND THE VITROS HBSAG CONFIRMATORY KIT.  THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR AND VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KIT AND IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK:FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM ANDPLASMA (HEPARIN, EDTA, AND SODIUM CITRATE) USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTICSYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE AND CHRONIC HEPATITIS B. IN ADDITION, THIS ASSAYMAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING IIBV DURING THE PERINATAL PERIOD.VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRALOR: FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE IN VITROQUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA USING VITROS HBSAG REAGENT PACKS. THE VITROS HBSAG CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTICSYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTSANTI-HBC REAGENT PACKS.(SEE APPROVAL ORDER FOR ADDITIONAL APPROVAL INFORMATION)
P060008|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/2009|07/13/2009|09M-0369|08/04/2009|APPR|APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 38 MM LENGTH TAXUS LIBERTÉ PACLITAXEL-ELUTING CORONARY STENT SYSTEM.  THE DEVICE SIZE WILL BE MARKETED UNDER THE TRADE NAME TAXUS LIBERTÉ LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS), AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.75 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
P970008|S043|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2009|03/05/2009|||OK30|CHANGES TO THE ETHYLENE OXIDE STERILIZATION PROCESS USED ON THE TARGIS SYSTEM COMPONENTS.
P960013|S043|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|1888 TENDRIL LEADS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2009|06/29/2009|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF LEAD COMPONENTS.
P990055|S010|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ADVIA CENTAUR COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY|NAF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2009|12/03/2009|||APPR|APPROVAL FOR THE CHANGE IN ANTIBODY GROWTH MANUFACTURING PROCESS FROM ASCITES FLUID TO CELL CULTURE.
P050046|S004|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE LEAD|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2009|06/26/2009|||APPR|APPROVAL OF A NEW PULL TESTER.
P030009|S033|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRODRIVER CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2009|03/04/2009|||OK30|CHANGE TO UPDATE THE METALLOGRAPHIC TEST METHOD.
P060033|S032|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2009|03/04/2009|||OK30|CHANGE TO UPDATE THE METALLOGRAPHIC TEST METHOD.
P030017|S092|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/08/2009|01/23/2009|||APPR|APPROVAL FOR A LABELING CHANGE IN REGARDS TO THE APPLICATION OF MEDICAL ADHESIVE BETWEEN THE DISTAL LEAD AND SUTURE SLEEVE.
P030049|S003|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2009|03/04/2009|||OK30|CHANGE INVOLVING THE MANUFACTURING OF (BIOTINLATED) ANTIBODY AND ANTIGEN.
P030040|S003|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBCIGM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2009|03/04/2009|||OK30|CHANGE INVOLVING THE MANUFACTURING OF (BIOTINLATED) ANTIBODY AND ANTIGEN.
P030056|S003|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2009|03/04/2009|||OK30|CHANGE INVOLVING THE MANUFACTURING OF (BIOTINLATED) ANTIBODY AND ANTIGEN.
P040004|S003|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBCT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2009|03/04/2009|||OK30|CHANGE INVOLVING THE MANUFACTURING OF (BIOTINLATED) ANTIBODY AND ANTIGEN.
P970003|S106|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/05/2009|03/06/2009|||APPR|APPROVAL FOR CHANGING THE TRADE NAME OF THE VNS THERAPY PERENNIA MODEL 303 LEAD TO VNS THERAPY PERENNIADURA MODEL 303 LEAD.
P840001|S128|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTOREADVANCED RECHARGEABLE|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2009|04/01/2009|||APPR|APPROVAL FOR REDESIGN OF THE 6-PIN FILTERED FEEDTHROUGH.
P050037|S019|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|02/25/2009|||OK30|EVALUATION OF RE-QUALIFICATION OF STERILIZER AFTER MAINTENANCE.
P050052|S021|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|02/25/2009|||OK30|EVALUATION OF RE-QUALIFICATION OF STERILIZER AFTER MAINTENANCE.
P040047|S013|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|06/24/2009|||APPR|APPROVAL FOR THE REQUALIFICATION OF THE GETINGE 6612AR1 STERILIZER.
P890003|S163|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD-2 & BRILLIANT S+|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P030036|S012|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P010015|S061|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN LV & CS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P950024|S016|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P830061|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/CAPSURE SP/CAPSURE SP NOVUS/CAPSURE SENSE/VITATRON EXCELLENCE +/PS+/CRYSTALLINE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P920015|S052|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT & SPRINT QUATTRO & SPRINT QUATTRO SECURE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P980050|S040|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P850089|S061|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z/CAPSURE Z/SP NOVUS & VITATRON IMPULSE & IMPLUSE II & VIATRON EXCELLENCE SS +|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P930039|S030|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX & CAPSUREFIX NOVUS & VITATRON PIROUET S+ & VITATRON CRYSTALLINE ACTFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P980016|S177|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2009|03/06/2009|||OK30|ADDITION OF A SUPPLIER FOR AN EXTRUDED COMPONENT USED TO MANUFACTURE ADHESIVE.
P960058|S078|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/05/2009|||OK30|ADDITION OF VISUAL ACCEPTANCE CRITERIA TO THE RECEIVING INSPECTION INSTRUCTION.
P040047|S014|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/06/2009|||OK30|CHANGE IN THE MIXING OPERATION FOR THE DEVICE.
P820003|S089|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/06/2009|||OK30|TRANSFERRING THE FINAL IN-PROCESS INSPECTION AND FINAL PACKAGING PROCESS STEPS FOR THE MODEL 5409 POUCH-DISPOSABLE, 5PK TO THE CONTRACT MANUFACTURER¿S FACILITY IN MEDINA, MINNESOTA.
P950021|S010|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ADVIA CENTAUR PSA ASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/06/2009|||OK30|CHANGE INVOLVING THE CONJUGATED ANTIBODIES FOR THE DEVICE.
P990055|S011|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ADVIA CENTAUR PSA & CPSA ASSAYS|NAF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/06/2009|||OK30|CHANGE INVOLVING THE CONJUGATED ANTIBODIES FOR THE DEVICE.
P980037|S029|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|02/27/2009|||OK30|MODIFICATION TO THE ALLOWABLE COMBINATIONS OF MEDRAD INTERVENTIONAL/ POSSIS (MIP) PRODUCTS THAT MAY BE STERILIZED WITH AN ETHYLENE OXIDE (EO) STERILIZATION CYCLE.
P050037|S020|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/06/2009|||OK30|CHANGE IN THE MIXING OPERATION FOR THE DEVICE.
P050052|S022|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/06/2009|||OK30|CHANGE IN THE MIXING OPERATION FOR THE DEVICE.
P970004|S070|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF NEUROSTIMULATION LEADS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/02/2009|||OK30|ALTERNATE SUPPLIER FOR AN EXTRUDED TUBING COMPONENT.
P840001|S129|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD FAMILY OF NEUROSTIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/02/2009|||OK30|ALTERNATE SUPPLIER FOR AN EXTRUDED TUBING COMPONENT.
P960009|S062|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|03/02/2009|||OK30|ALTERNATE SUPPLIER FOR AN EXTRUDED TUBING COMPONENT.
P950022|S058|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA ST OPTIM & DURATA LEADS|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|02/27/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, LLC IN ARECIBO, PUERTO RICO.
P030054|S116|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS II+ HF CRT-D & PROMOTE CRT-D|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2009|02/27/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, LLC IN ARECIBO, PUERTO RICO.
P980016|S178|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2009|03/16/2009|||APPR|APPROVAL FOR DESIGN CHANGES TO THE 6-PIN FILTERED FEEDTHROUGH (FFT) USED IN THE ENTRUST ICD DEVICES.
P040024|S035|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GELS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|03/05/2009|||OK30|CHANGES AS FOLLOWS: 1) ADD A NEW RAW MATERIAL SUPPLIER; 2) CHANGE THE SITE FOR RAW MATERIAL QUALITY ASSURANCE TESTING TO Q-MED AB; 3) ADD A HEAVY METALS TEST FOR RAW MATERIALS; AND 4) MODIFY A TEST METHOD FOR THE QUALITY CONTROL OF THE FINISHED PRODUCT.
P060025|S004|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|ATS 3F AORTIC BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|02/19/2009|||OK30|CHANGE TO THE TISSUE FIXATION PROCESS.
P030005|S056|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR PULSE GENERATORS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|03/11/2009|||OK30|MOVEMENT OF THE HYBRID SUBCOMPONENT ASSEMBLY FROM THE MINNESOTA FACILITY TO CLONMEL, IRELAND.
P990013|S025|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|03/11/2009|||OK30|ADDITION OF A NEW REFRIGERATOR AT THE ALISO VIEJO FACILITY.
P000026|S002|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||Intraocular pressure lowering implant|STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE|OGO|OP|30-Day Notice||N|02/09/2009|03/11/2009|||OK30|ADDITION OF A NEW REFRIGERATOR AT THE ALISO VIEJO FACILITY.
P030016|S012|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA|MTA|OP|30-Day Notice||N|02/09/2009|03/11/2009|||OK30|ADDITION OF A NEW REFRIGERATOR AT THE ALISO VIEJO FACILITY.
P010025|S015|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2009|03/16/2009|||APPR|APPROVAL FOR A CHANGE TO THE IMAGE IMPLANT DETECTION PROCESS.
P980035|S128|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA IPGS, SIGMA IPGS, ENPULSE IPGS, ENRHYTHM IPGS, AT500 PACING SYSTEM, ADAPTA/SENSIA/VERSA IPGS AND RELIA IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|06/24/2009|||APPR|APPROVAL OF A NEW LEAK TESTER.
P010031|S143|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/CONCERTO/MAXIMO/CONSULTA FAMILIES OF ICDS & CRT-DS||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|06/24/2009|||APPR|APPROVAL OF A NEW LEAK TESTER.
P010015|S062|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC & INSYNC II CRT-P|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|06/24/2009|||APPR|APPROVAL OF A NEW LEAK TESTER.
P990001|S050|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C & T SERIES IPG & DEMA FAMILIES|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|06/24/2009|||APPR|APPROVAL OF A NEW LEAK TESTER.
P980016|S179|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA/VIRTUOSO II FAMILIES OF ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|06/24/2009|||APPR|APPROVAL OF A NEW LEAK TESTER.
P040038|S016|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2009|03/31/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE PACKAGING OF THE DEVICE.
P970012|S051|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|06/24/2009|||APPR|APPROVAL OF A NEW LEAK TESTER.
P890003|S164|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|06/24/2009|||APPR|APPROVAL OF A NEW LEAK TESTER.
P980022|S047|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CGMS IPRO CONTINUOUS GLOCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2009|04/06/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE SOLUTIONS SOFTWARE FOR THE CGMS IPRO CONTINUOUS GLUCOSE RECORDER (MMT-7319) TO ADD AN AUTO DETECT FEATURE TO ALLOW THE SOFTWARE TO AUTOMATICALLY RECOGNIZE THE COMPUTER¿S ACTIVE PORTS AND TO CORRECT PREVIOUSLY IDENTIFIED ANOMALIES.
P970054|S007|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|BIOTRIN INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE|MYL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|03/03/2009|||OK30|REMOVAL OF DAY 7 DROP OFF TESTING AND RELATED SPECIFICATION.
P970055|S007|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE|MYM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2009|03/03/2009|||OK30|REMOVAL OF DAY 7 DROP OFF TESTING AND RELATED SPECIFICATION.
P030054|S117|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/10/2009|04/08/2009|||APPR|APPROVAL FOR CURRENT/CURRENT+ AND PROMOTE/PROMOTE+ DEVICES INCLUDING CURRENT- DR CD2211-36Q, CURRENT+ VR CD1211-36Q, PROMOTE + CD3211-36Q, CURRENT VR CD1207-36Q, CURRENT DR 2207-36Q, AND PROMOTE CD3207-36Q. ADDITIONALLY, YOUREQUESTED APPROVAL TO INCLUDE THE DEVICES WITHIN AN ONGOING POST APPROVAL STUDY, PENDING FINAL APPROVAL BY THE OFFICE OF SURVEILLANCE AND BIOMETRICS. THAT POST-APPROVAL STUDY IS BEING CONDUCTED AS A CONDITION OF APPROVAL FOR P950022/S042, P030054/S067, AND P910023/S154.
P910023|S201|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/10/2009|04/08/2009|||APPR|APPROVAL FOR CURRENT/CURRENT+ AND PROMOTE/PROMOTE+ DEVICES INCLUDING CURRENT- DR CD2211-36Q, CURRENT+ VR CD1211-36Q, PROMOTE + CD3211-36Q, CURRENT VR CD1207-36Q, CURRENT DR 2207-36Q, AND PROMOTE CD3207-36Q. ADDITIONALLY, YOUREQUESTED APPROVAL TO INCLUDE THE DEVICES WITHIN AN ONGOING POST APPROVAL STUDY, PENDING FINAL APPROVAL BY THE OFFICE OF SURVEILLANCE AND BIOMETRICS. THAT POST-APPROVAL STUDY IS BEING CONDUCTED AS A CONDITION OF APPROVAL FOR P950022/S042, P030054/S067, AND P910023/S154.
P040028|S004|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD|SUITE 11|SAN DIEGO|CA|92121||Sensor,electro-optical(for cervical cancer)|CERVICAL IMAGING SYSTEM|MWM|OB|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2009|03/19/2009|||APPR|APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE LUMA PROBE COVER FROM TWO YEARS TO THREE YEARS.
P000053|S021|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2009|03/19/2009|||OK30|IMPLEMENTATION OF A BACK-UP IN-PROCESS TESTER.
P000053|S022|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2009|03/19/2009|||OK30|ALTERNATE MIXING VESSEL TO BE USED IN THE MANUFACTURE OF A SOLUTION.
P950032|S050|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2009|03/13/2009|||OK30|IMPLEMENTATION OF A NEW ASSAY FOR THE DETERMINATION OF COLLAGEN IN APLIGRAF.
P000039|S029|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|SEPTAL OCCLUDER AND MULTIFENESTRATED SEPTAL (CRIBRIFORM) OCCLUDER|MAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2009|04/08/2009|||APPR|APPROVAL FOR MODIFICATION IN PACKAGING MATERIALS AND THE USE OF A NEW SEALER TO ACCOMMODATE THE NEW PACKAGING MATERIALS.
P040038|S017|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2009|02/23/2009|||OK30|CHANGE TO THE STATIC WIRE BOND AND A CHANGE TO THE ADHESIVE DRYING TIME.
P020024|S023|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2009|04/08/2009|||APPR|APPROVAL FOR MODIFICATION IN PACKAGING MATERIALS AND THE USE OF A NEW SEALER TO ACCOMMODATE THE NEW PACKAGING MATERIALS.
P040040|S009|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2009|04/08/2009|||APPR|APPROVAL FOR MODIFICATION IN PACKAGING MATERIALS AND THE USE OF A NEW SEALER TO ACCOMMODATE THE NEW PACKAGING MATERIALS.
P060031|S002|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC EIA|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/12/2009|02/25/2009|||APPR|APPROVAL FOR CHANGES IN THE RECOMMENDATION FOR SPECIMEN STORAGE.
P960009|S063|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA & KINETRA NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2009|03/12/2009|||OK30|CHANGE IN THE IN-LINE MANUFACTURING TEST FOR SEAM WELD LEAK TEST INSPECTION PROCEDURE.
P840001|S130|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 IMPLANTABLE PULSE GENERATOR/SYNERGY & RESTORE FAMILIES OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2009|03/12/2009|||OK30|CHANGE IN THE IN-LINE MANUFACTURING TEST FOR SEAM WELD LEAK TEST INSPECTION PROCEDURE.
P050051|S004|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM|LOM|MI|Normal 180 Day Track||N|02/12/2009|07/23/2009|||APPR|APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT AUSAB ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.ARCHITECT AUSAB REAGENT KIT ON ARCHITECT I 1000SR:THE ARCHITECT AUSAB ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY(CMIA) FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN(ANTI-HBS) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA, LITHIUMHEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED FOR QUANTITATIVEMEASUREMENT OF ANTIBODY RESPONSE FOLLOWING HEPATITIS B VIRUS (HBV) VACCINATION,DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE LABORATORY DIAGNOSIS OF HBV DISEASEASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.ARCHITECT AUSAB CALIBRATORS ON ARCHITECT I 1000SR:THE ARCHITECT AUSAB CALIBRATORS ARE USED TO CALIBRATE THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT AUSAB CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANYOTHER ANTI-HBS ASSAY.ARCHITECT AUSAB CONTROLS ON ARCHITECT I 1000SR:THE ARCHITECT AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THEARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THEPERFORMANCE OF THE ARCHITECT AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANYOTHER ANTI-HBS ASSAY.
P970004|S071|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2009|03/12/2009|||OK30|CHANGE IN THE IN-LINE MANUFACTURING TEST FOR SEAM WELD LEAK TEST INSPECTION PROCEDURE.
P030024|S010|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/2009|09/11/2009|||APPR|APPROVAL FOR THE REVISION OF THE INTENDED USE TO INCLUDE USER OF THE VITROS 5600 INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE ANTI-HBC ASSAY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR AND IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK: FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (LGG AND IGM) TO HEPATITIS B CORE ANTIGEN(TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATESERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THELABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION. THE PRESENCE OF ANTI-HBC MAY BE USED AS AN AID IN THE DETERMINATION OF EXPOSURE TOHBV INFECTION FOR INDIVIDUALS PRIOR TO HBV VACCINATION.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE IN VITROQUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B VIRUS CORE ANTIGEN (TOTAL ANTI HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUMUSING VITROS ANTI-HBC IGM REAGENT PACKS.  THE VITROS ANTI-HBC CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQIMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACKS.
P820003|S090|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/09/2009|||OK30|TRANSFER OF THE FINAL IN-PROCESS INSPECTION AND FINAL PACKAGING PROCESS STEPS FROM MEDTRONIC RICE CREEK FACILITY TO THE CONTRACT MANUFACTURER.
P000040|S013|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HTA SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|02/13/2009|05/14/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HTA PROCEDURE SHEATH (A COMPONENT OF THE HTA SYSTEM) WHICH INCLUDE THE ADDITION OF THE CERVICAL SEAL ASSIST COMPONENT AND A REDESIGN OF THE RESERVOIR TIP.  THE SHEATH, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTA PROCERVA PROCEDURE SHEATH.
P040038|S018|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|05/07/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR CORPORATION, TEMECULA, CALIFORNIA, AND A STERILIZATION SITE LOCATED AT STERIGENICS, LOS ANGELES, CALIFORNIA.
P060033|S033|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS & SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|11/13/2009|||APPR|APPROVAL FOR A MODIFICATION IN THE PREPARATION OF TEST EXTRACTS.
P950037|S069|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS DR-T, PHILOSII DR-T AND CYLOS DR-T|NVZ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/23/2009|||APPR|APPROVAL FOR AND UPDATE TO THE BIOTRONIK HOME MONITORING SERVICE CENTER TO VERSION 3.2.
P010012|S202|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/12/2009|||OK30|ADDITIONAL SUPPLY SOURCE FOR LOW VOLTAGE CAPACITORS TO THE DEVICE FAMILY.
P960040|S189|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/12/2009|||OK30|ADDITIONAL SUPPLY SOURCE FOR LOW VOLTAGE CAPACITORS TO THE DEVICE FAMILY.
P070027|S007|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/09/2009|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR CUTTING AND SEALING THE GRAFT MATERIAL.
P000009|S034|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS VR-T, DR-T & A+-T; LEXOS DR-T & VR-T; XELOS DR-T; LUMOS DR-T & VR-T|MRM|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/23/2009|||APPR|APPROVAL FOR AND UPDATE TO THE BIOTRONIK HOME MONITORING SERVICE CENTER TO VERSION 3.2.
P070007|S006|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/09/2009|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR CUTTING AND SEALING THE GRAFT MATERIAL.
P050023|S021|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS AND KRONOS LV-T|MRM|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/23/2009|||APPR|APPROVAL FOR AND UPDATE TO THE BIOTRONIK HOME MONITORING SERVICE CENTER TO VERSION 3.2.
P070008|S010|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV-T|NKE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|03/23/2009|||APPR|APPROVAL FOR AND UPDATE TO THE BIOTRONIK HOME MONITORING SERVICE CENTER TO VERSION 3.2.
P010031|S144|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/INSYNC MARQUIS ICDS||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|10/01/2009|||APPR|APPROVAL FOR REPLACING OBSOLETE EQUIPMENT WITH NEW EQUIPMENT.
P980016|S180|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR/VR/MAXIMO DR/VR/INTRINSIC ICDS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|10/01/2009|||APPR|APPROVAL FOR REPLACING OBSOLETE EQUIPMENT WITH NEW EQUIPMENT.
P980035|S129|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2009|10/01/2009|||APPR|APPROVAL FOR REPLACING OBSOLETE EQUIPMENT WITH NEW EQUIPMENT.
P030054|S118|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process||N|02/17/2009|03/23/2009|||APPR|APPROVAL FOR THE MODIFICATIONS OF THE C64 IC (VERSION P) FOR THE EPIC II / ATLAS II PLATFORM OF ICDS, AND SIO2 IC (VERSION G) FOR THE EPIC+ / ATLAS+ AND EPIC II / ATLAS II PLATFORM OF ICDS.
P040044|S011|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|M5 MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2009|04/08/2009|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE 6F/7F MYNX VASCULAR CLOSURE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME M5 MYNX VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F PROCEDURAL SHEATH.
P910023|S202|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process||N|02/17/2009|03/23/2009|||APPR|APPROVAL FOR THE MODIFICATIONS OF THE C64 IC (VERSION P) FOR THE EPIC II / ATLAS II PLATFORM OF ICDS, AND SIO2 IC (VERSION G) FOR THE EPIC+ / ATLAS+ AND EPIC II / ATLAS II PLATFORM OF ICDS.
P830055|S109|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2009|05/18/2009|||APPR|APPROVAL FOR THE ADDITION OF THE SIGMA CR150 FEMORAL COMPONENTS AS COMPATIBLE COMPONENTS WITH THE MBT TIBIAL TRAYS AND THE CURVED RP TIBIAL INSERTS.
P060003|S004|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2009|03/05/2009|||OK30|ADDITION OF A NEW QUALITY CONTROL TESTING PROCEDURE TO EVALUATE THE SUITABILITY OF RECALCIFIED NONREACTIVE PLASMA USED IN ANTI-HBS POSITIVE COMPONENTS.
P940015|S014|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC & SYNVISC-ONE (HYLAN G-F 20)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2009|03/11/2009|||OK30|REMOVAL OF THE CYTOTOXICITY TEST (USP<87> BIOLOGICAL REACTIVITY TEST, IN VITRO) FROM THE HYLAN B-10 GEL IN-PROCESS SPECIFICATION FOR THE DEVICE.
P880003|S096|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|DURA STAR RX PTCA BALLOON DILATATION CATHETER|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|07/02/2009|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE MANUFACTURING SITE FOR THE NC NINJA BALLOON COMPONENT.
P040050|S003|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/18/2009|06/26/2009|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO REFLECT THE FINDINGS OF THE ENHANCED SURVEILLANCE STUDY.
P070027|S008|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR TALENT ABDOMINAL STANT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|03/16/2009|||OK30|TEMPORARY REWORK OF THE TALENT ABDOMINAL AND TALENT THORACIC STENT GRAFT SYSTEMS FOR THE COILTRAC DELIVERY SYSTEM TO THE XCELERANT DELIVERY SYSTEM.
P070007|S007|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|03/16/2009|||OK30|TEMPORARY REWORK OF THE TALENT ABDOMINAL AND TALENT THORACIC STENT GRAFT SYSTEMS FOR THE COILTRAC DELIVERY SYSTEM TO THE XCELERANT DELIVERY SYSTEM.
P050033|S006|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|ELEVESS|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|11/05/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN BEDFORD, MASSACHUSETTS.
P980035|S130|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/05/2009|||APPR|APPROVAL FOR CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING.
P010015|S063|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC CARDIAC RESYNCHRONIZATION THERAPY PACING (CRT-P) & INSYNC III CRT-P|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/05/2009|||APPR|APPROVAL FOR CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING.
P980016|S181|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA ICD FAMILIES|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/05/2009|||APPR|APPROVAL FOR CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING.
P970012|S052|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/05/2009|||APPR|APPROVAL FOR CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING.
P890003|S165|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/05/2009|||APPR|APPROVAL FOR CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING.
P010031|S145|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC FAMILIES OF ICDS/CONCERTO/MAXIMO II/CONSULTA FAMILIES OF CRT-DS||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/05/2009|||APPR|APPROVAL FOR CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING.
P990001|S051|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA FAMILIES/C & T SERIES DEVICES|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/05/2009|||APPR|APPROVAL FOR CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING.
P950005|S025|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT AND NAVISTAR RMT CATHETERS|LPB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/10/2009|||APPR|APPROVAL FOR A THREE (3) YEAR OF SHELF LIFE FOR THE CATHETER.
P990025|S017|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT CATHETERS|LPB|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2009|08/10/2009|||APPR|APPROVAL FOR A THREE (3) YEAR OF SHELF LIFE FOR THE CATHETER.
P960040|S190|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN & CONFIENT|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2009|03/18/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE SETSCREW DESIGN, SEAL PLUG DESIGN, LABELING FOR THE TORQUE WRENCH, AND THE MODEL 6628 TORQUE WRENCH ACCESSORY KIT AS A STAND ALONE ACCESSORY.
P010012|S203|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS & LIVIAN|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2009|03/18/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE SETSCREW DESIGN, SEAL PLUG DESIGN, LABELING FOR THE TORQUE WRENCH, AND THE MODEL 6628 TORQUE WRENCH ACCESSORY KIT AS A STAND ALONE ACCESSORY.
P050009|S007|Biomet, Inc.|P.O. Box 587||Warsaw|IN|46581|0587|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|C2A TAPER ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2009|03/13/2009|||OK30|USE OF AN OPTIONAL CLEANING PROCESS FOR THE C2A-TAPER ACETABULAR SYSTEM SCREWS.
P940016|S011|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)|MMY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/19/2009|04/20/2009|||APPR|APPROVAL FOR AN EXTENSION OF SHELF-LIFE FROM 5 YEARS TO 6 YEARS FOR THE PRECIPITATE FILTER COMPONENT OF THE DEVICE.
P940016|S012|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)|MMY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/19/2009|04/20/2009|||APPR|APPROVAL FOR A CHANGE TO THE PACKAGING MATERIAL IN THE POUCH USED FOR THE HEPARIN ADSORBER COMPONENT OF THE DEVICE.
P930014|S031|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2009|03/16/2009|||OK30|INTRODUCTION OF AN EXPIRATION DATE FOR PERKADOX-16.
P040020|S013|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2009|03/16/2009|||OK30|INTRODUCTION OF AN EXPIRATION DATE FOR PERKADOX-16.
P840064|S040|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2009|08/13/2009|||APPR|APPROVAL FOR AN ALTERNATE CLEAN ROOM FOR ASEPTIC FILLING AS PART OF A GENERAL MANUFACTURING PLANT EXPANSION.
P890047|S028|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2009|08/13/2009|||APPR|APPROVAL FOR AN ALTERNATE CLEAN ROOM FOR ASEPTIC FILLING AS PART OF A GENERAL MANUFACTURING PLANT EXPANSION.
P030026|S016|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/20/2009|07/15/2009|||APPR|APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE ANTI-HBC IGM ASSAY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTICPRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBCCALIBRATOR AND IS INDICATED FOR:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK:FOR THE IN VITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM)IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (HEPARIN, EDTA AND CITRATE) AND NEONATE SERUMUSING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTICSYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THELABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM WHEN USED FOR THE INVITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN (ANTI-HBC IGM) INHUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA, HEPARIN OR CITRATE) AND NEONATE SERUM USING VITROS ANTI-HBC IGM REAGENT PACKS.THE VITROS ANTI-HBC IGM CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THEVITROS 5600 INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACKS.
P060027|S011|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE|NIK|CV|30-Day Notice|Change Design/Components/Specifications/Material|N|02/20/2009|10/27/2009|||APPR|APPROVAL FOR THE PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE.  THE DEVICE IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING ARRHYTHMIAS.  THE DEVICE IS ALSO INDICATED FOR THE REDUCTION OF HEART FAILURE SYMPTOMS IN MEDICALLY OPTIMIZED NYHA FUNCTIONAL CLASS III AND IV PATIENTS WITH LEFT VENTRICULAR EJECTION FRACTION OF 35% OR LESS, AND A QRS DURATION OF 150 MS OR LONGER.
P960058|S079|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2009|03/18/2009|||APPR|APPROVAL FOR THE HIRES 90K MOCK-UP AS STERILE INSTEAD OF NON-STERILE, AND TO ESTABLISH THE SHELF LIFE AT THREE YEARS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM HIRES 90K MOCK-UP (MOCK-UP) AND IS INDICATED FOR INDIVIDUALS AGED TWELVE MONTHS AND OLDER WITH SEVERE-TO PROFOUND SENSORINEURAL HEARING LOSS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.
P000025|S040|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2009|03/25/2009|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE ELECTRODE WIRES.
P870072|S041|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/23/2009|04/24/2009|||APPR|APPROVAL TO MODIFY THE LABELING TO INCLUDE POST-APPROVAL STUDY INFORMATION FOR THE IVAD SYSTEM.
P020018|S032|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track||N|02/23/2009|04/02/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE TOP CAP TRIGGER WIRE, DELIVERY SYSTEM POSITIONER, AND TRIGGER KNOB SET SCREW.
P050020|S011|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2009|04/13/2009|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT NUTEK CORPORATION, HAYWARD, CALIFORNIA, TO PERFORM STERILIZATION OF THE SENSOR DELIVERY UNIT.
P980016|S182|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2009|03/24/2009|||OK30|TRANSFER OF PROCESSES TO A CONTRACT MANUFACTURING FACILITY.
P840001|S131|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTOREULTRA, RESTOREADVANCED RECHARGEABLE|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2009|04/20/2009|||APPR|APPROVAL FOR MODEL 74001 (1X4) POCKET ADAPTOR AND MODEL 74002 (2X4) POCKET ADAPTOR.
P890003|S166|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MODEL 2090 MEDTRONIC / VITATRON CARELINK PROGRAMMER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2009|04/24/2009|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P070007|S008|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2009|03/20/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC VASCULAR GALWAY LIMITED, GALWAY, IRELAND.
P010015|S064|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2009|04/24/2009|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P980016|S183|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2009|04/24/2009|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P010031|S146|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2009|04/24/2009|||APPR|APPROVAL FOR ADDITIONAL CHANGES TO SUPPORT MIGRATION FROM OS/2 TO XPE.
P790018|S051|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|HALL EASY-FIT PROSTHETIC HEART VALVE|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/24/2009|12/18/2009|||APPR|APPROVAL FOR LABELING CHANGES.
P080004|S002|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|INTRAOCULAR LENS|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2009|07/23/2009|||APPR|APPROVAL FOR A CHANGE IN THE CONTRACTED LIMULUS AMEBOCYTE LYSATE (LAL) TEST LABORATORY.
P040037|S017|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2009|03/20/2009|||OK30|CHANGES TO THE PACKAGING COMPONENT FOR THE DEVICE.
P910073|S077|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/2009|11/10/2010|||APPR|APPROVAL FOR ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES.
P830060|S062|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD TUNNELER MODEL 6888|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/2009|11/10/2010|||APPR|APPROVAL FOR ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES.
P840001|S132|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2009|03/19/2009|||OK30|CHANGE TO THE RESISTANCE WELDING OPERATION.
P960009|S064|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA THERAPY FOR DBS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2009|03/19/2009|||OK30|CHANGE TO THE RESISTANCE WELDING OPERATION.
P960013|S044|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Pulse generator, permanent, implantable|TENDRIL FAMILIES OF LEADS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2009|05/21/2009|||APPR|APPROVAL FOR THE USE OF AN ADDITIONAL SUPPLIER FOR THE CRIMP CORE COMPONENT.
P050004|S001|ELECTRO MEDICAL SYSTEMS (EMS SA)|CH. DE LA VUARPILLIERE 31||NYON, VAUD||CH-12|1260|Generator, shock-wave, for pain relief|EMS-SWISS DOLORCLAST|NBN|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2009|08/28/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT E.M.S. ELECTRO MEDICAL SYSTEMS, SA, NYON, SWITZERLAND.
P950024|S017|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR/BIOPOLAR LEADS|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2009|07/29/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CO. IN VILLALBA, PUERTO RICO.
P070015|S013|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2009|03/16/2009|||OK30|INCREASE OF THE RELATIVE HUMIDITY SPECIFICATION IN THE CLEAN ROOM.
P890003|S167|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODEL 2490C CARELINK MONITORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2009|03/26/2009|||OK30|CHANGES TO THE INLINE QUALITY TEST SYSTEMS.
N18286|S018|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM PLUS HEMOSTASIS KIT|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2009|06/10/2009|||APPR|APPROVAL OF CHANGES TO THE MANUFACTURING OF THE HUMAN THROMBIN COMPONENT OF THE GELFOAM PLUS HEMOSTASIS KIT THROUGH THE ADDITION OF A SOLVENT/ DETERGENT STEP (HUMAN THROMBIN VH S/D).  THE THROMBIN IS TO BE MANUFACTURED AND SUPPLIED BY BAXTER HEALTHCARE CORPORATION.
P990009|S025|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2009|01/07/2010|||APPR|APPROVAL FOR INCLUSION OF HUMAN THROMBIN THAT HAS BEEN TREATED WITH A SECOND VIRAL INACTIVATION STEP (SOLVENT DETERGENT PROCESS) IN THE FLOSEAL HEMOSTATIC MATRIX KIT AS WELL AS APPROVAL FOR ASSOCIATED LABELING CHANGES TO REFLECT THE ADDITIONAL VIRAL INACTIVATION STEP FOR THE THROMBIN COMPONENT.
P080011|S001|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2009|03/25/2009|||OK30|ADDITION OF TWO ALTERNATE QUALIFIED SUPPLIERS OF A RAW MATERIAL USED IN THE MANUFACTURING OF COMFILCON A LENSES.
P070006|S001|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT TB TEST|OJN|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/27/2009|07/09/2010|||APPR|APPROVAL FOR THE USE OF T-CELL XTEND REAGENT WITH THE T-SPOT.TB TEST, IN ORDER TO EXTEND THE TIME FROM SAMPLE COLLECTION TO SAMPLE PROCESSING FROM WITHIN 8 HOURS OF VENIPUNCTURE TO BETWEEN 23 AND 30 HOURS POST VENIPUNCTURE; AND TO MAKE A TECHNICAL CORRECTION TO THE T-SPOT.TB TEST PACKAGE INSERT TO CHANGE THE NUMBER OF BLOOD COLLECTION TUBES REQUIRED FROM (2) 6 ML HEPARIN TUBES TO (1) 6 ML HEPARIN TUBE.  THE T-CELL XTEND REAGENT IS INDICATED FOR USE WITH THE T-SPOT.TB TEST FOR THE PRE-TREATMENT OF WHOLE BLOOD PRIOR TO LYMPHOCYTE SEPARATION .  THE REAGENT AIDS IN THE REMOVAL OF SELECTED WHITE BLOOD CELLS FROM WHOLE BLOOD STORED AT ROOM TEMPERATURE (18-25 DEGREES C).
P980022|S048|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2009|04/09/2009|||APPR|APPROVAL FOR DESIGN CHANGES TO THE MMT-7002 AND MMT-7003 GLUCOSE SENSORS MODELS AND A NEW SUPPLIER QUALIFICATION. THE DESIGN CHANGESINCLUDED AN INCREASE OF THE NEEDLE TUNNEL HEIGHT AND BASE FROM 0.034" TO 0.036" AND0.030" AND 0.031", RESPECTIVELY. THESE CHANGES WERE INTENDED TO REDUCE THE PROBABILITY OF A USER HAVING DIFFICULTY WITH REMOVING THE NEEDLE AFTER SENSOR INSERTION. FURTHER, THE CONNECTOR LEDGE OF THE SENOR BASE WAS INCREASED FROM 0.007" TO 0.011" TO REDUCE RELATIVEROTATIONAL MOTION BETWEEN THE SENSOR BASE CONNECTOR AND GST TRANSMITTER. PHILLIPS PLASTICS WAS ALSO QUALIFIED AS A NEW SUPPLIER FOR THE GLUCOSE SENSOR BASES IN THIS SUPPLEMENT. THE QUALIFICATION INCLUDED MODIFICATIONS INCLUDING MODIFICATIONS TO THENEEDLE GUARD CORE PIN, A MANUFACTURING TOOLING DEVICE. THIS DEVICE IS INTENDED TOCONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS. THISINFORMATION IS INTENDED TO SUPPLEMENT, NOT REPLACE, BLOOD GLUCOSE INFORMATION OBTAINED USING A STANDARD HOME GLUCOSE-MONITORING DEVICES. THIS INFORMATION MAY ALLOW IDENTIFICATION OF PATTERNS OF GLUCOSE LEVEL EXCURSIONS ABOVE OR BELOW THE DESIRED RANGE, FACILITATING THERAPY ADJUSTMENTS WHICH MAY MINIMIZE THESE EXCURSIONS.
P980044|S009|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ JOINT FLUID THERAPY|MOZ|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2009|07/08/2009|||APPR|APPROVAL FOR A DISTRIBUTION SITE CHANGE FROM ONE ADDRESS IN MEMPHIS, TENNESSEE TO ANOTHER ADDRESS IN MEMPHIS, TENNESSEE.
P890003|S168|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC / VITATRON CARELINK PROGRAMMING OPERATING SYSTEM AND MEDICAL DEVICE APPLICATION SOFTWARE|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P980050|S041|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P860004|S105|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II IMPLANTABLE INFUSION PUMPS||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2009|05/14/2009|||OK30|ADDITION OF VISUAL INSPECTIONS OF THE PUMP SEPTUMS IN MANUFACTURING.
P820003|S091|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P850051|S070|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VARIOUS FAMILIES OF PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P050007|S013|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSURE SE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/02/2009|05/01/2009|||APPR|APPROVAL FOR THE ADDITION OF A FIN TO THE PUSHER BLOCK COMPONENT OF THE DEVICE.
P900061|S083|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD END CAP KIT/ LEAD ADAPTOR SLEEVE KIT/UPSIZING SLEEVE KIT|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P930022|S009|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P970012|S053|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P980016|S184|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P980035|S131|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650&800/900 & SIGMA/MEDTRONIC 350/RELIA/ENPULSE II/AT500/ADAPTA/VERSA/SENSIA/ENRHYTHM FAMILIES OF IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P990001|S052|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA FAMILIES/C & T SERIES DEVICES|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P010015|S065|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC III|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P010031|S147|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS|NIK|CV|Normal 180 Day Track||N|03/02/2009|05/21/2009|||APPR|APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
P060017|S003|JANSSEN DIAGNOSTICS|700 US HIGHWAY RTE 202 SOUTH||RARITAN|NJ|08869||Rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection|GENESEARCH BREAST LYMPH NODE ASSAY|OCB|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2009|07/09/2009|||APPR|APPROVAL FOR: 1) A MANUFACTURING SITE LOCATED AT VERIDEX, LLC IN WARREN, NEW JERSEY; 2) THE ADDITION OF A SECOND EXISTING SITE; AND 3) A CHANGE IN RAW MATERIAL SPECIFICATIONS.
P950029|S041|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2009|06/11/2009|||APPR|APPROVAL FOR THE ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1.
P070015|S014|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2009|09/11/2009|||APPR|APPROVAL FOR A CHANGE TO IN-PROCESS INSPECTION ACCEPTANCE CRITERIA.
P980052|S004|TMJ CONCEPTS|2233 KNOLL DRIVE||VENTURA|CA|93003||Joint, temporomandibular, implant|PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM|LZD|DE|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/2009|09/02/2009|||APPR|APPROVAL FOR MODIFIED LABELING.
P900030|S011|Allergan, Inc.|71 SOUTH LOS CARNEROS ROAD||GOLETA|CA|93111||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|CONTIGEN BARD COLLAGEN IMPLANT|LNM|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/03/2009|10/02/2009|||APPR|APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDES INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT C.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTIGEN BARD COLLAGEN IMPLANT AND IS INDICATED FOR USE ONLY IN THE TREATMENT OF URINARY INCONTINENCE DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD, POOR OR NONFUNCTIONING BLADDER OUTLET MECHANISM) THAT MAY BE HELPED BY A LOCALLY INJECTED BULKING AGENT.  CONTIGEN IMPLANT THERAPY SHOULD BE INITIATED ONLY IN PATIENTS WHO HAVE SHOWN NO IMPROVEMENT IN THEIR INCONTINENCE FOR AT LEAST 12 MONTHS.
P030029|S005|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS & CONTROL MATERIAL|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/03/2009|04/09/2009|||APPR|APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICE ADVIA CENTAUR ANTI-HBS READY PACK REAGENTS AND CALIBRATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR'S) AND ADVIA CENTAUR XP ANTI-HBS ASSAY AND IS INDICATED FOR:ADVIA CENTAUR ANTI-HBS READY PACK REAGENTS AND CALIBRATORTHE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMANSERUM OR PLASMA (EDTA, OR HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OFSUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWINGHBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITHOTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATEDWITH HBV INFECTION. A REACTIVE ASSAY RESULTS WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.ADVIA CENTAUR ANTI-HBS CONTROL MATERIALFOR MONITORING THE PERFORMANCE OF THE ANTI-HBS ASSAY ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS.
P950020|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CORONARY FLEXTOME CUTTING BALLOON DEVICE|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2009|04/13/2009|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM FOR RADIATION STERILIZATION.
P950029|S042|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY DR & SR|NVZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/2009|04/02/2009|||APPR|APPROVAL FOR LABELING CHANGES TO THE REPLY DR AND REPLY SR IMPLANT MANUALS.
P910077|S092|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATTITUDE INDUCTIVE COMMUNICATOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/2009|04/28/2009|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481, VERSION 1.5.
P030054|S119|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF / ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/2009|04/14/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HIGH VOLTAGE CAPACITORS FOR ATLAS, +/II, CURRENT AND PROMOTE, RF/+ HE (36 J) AND EPIC, +/II CURRENT AND PROMOTE, RF/+ SE (30 J) FAMILIES OF ICD/CRT-D DEVICES.
P910023|S203|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/2009|04/14/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HIGH VOLTAGE CAPACITORS FOR ATLAS, +/II, CURRENT AND PROMOTE, RF/+ HE (36 J) AND EPIC, +/II CURRENT AND PROMOTE, RF/+ SE (30 J) FAMILIES OF ICD/CRT-D DEVICES.
P980016|S185|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO ICDS|LWS|CV|30-Day Notice||N|03/04/2009|04/02/2009|||OK30|MODIFICATION OF THE INCOMING VISUAL INSPECTION SAMPLING PLAN.
P010031|S148|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2009|04/02/2009|||OK30|MODIFICATION OF THE INCOMING VISUAL INSPECTION SAMPLING PLAN.
P950029|S043|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY SR/DR & RHAPSODY SR/DR & REPLY SR/DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2009|04/02/2009|||OK30|CHANGE IN THE DRYING METHOD FOR THE HYBRID MODULE.
P980049|S046|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2009|04/02/2009|||OK30|CHANGE IN THE DRYING METHOD FOR THE HYBRID MODULE.
P060027|S012|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO 6750 CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2009|04/02/2009|||OK30|CHANGE IN THE DRYING METHOD FOR THE HYBRID MODULE.
P980035|S132|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900 IPGS/ENPULSE/SIGMA/MEDTRONIC 350 SERIES/AT500/ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2009|04/03/2009|||OK30|ADDITION OF A NEW BARB WELDING SYSTEM.
P990001|S053|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA FAMILY (INCLUDES CLARITY DDDR, CLARITY SSIR, DIAMOND III, RUBY III, TOPAZ III, JADE III, VITA DDDR AND VITA II)|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2009|04/03/2009|||OK30|ADDITION OF A NEW BARB WELDING SYSTEM.
P970012|S054|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2009|04/03/2009|||OK30|ADDITION OF A NEW BARB WELDING SYSTEM.
P010015|S066|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSYNC CRT-P & INSYNC III CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2009|04/03/2009|||OK30|ADDITION OF A NEW BARB WELDING SYSTEM.
P980022|S049|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP & GUARDIAN REAL-TIME MONITOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|04/02/2009|||OK30|CHANGE TO THE KEYPAD ASSEMBLY.
P060022|S004|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|04/03/2009|||OK30|ALTERNATE MEASUREMENT SYSTEM FOR MEASURING THE AKREOS LENS HAPTICS.
P060008|S013|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/06/2009|06/28/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980016|S186|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|04/03/2009|||OK30|AUTOMATE THE MANUFACTURING PROCESS FOR THE INSERT-MOLDED BOND PAD ARRAY COMPONENT.
P010031|S149|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|04/03/2009|||OK30|AUTOMATE THE MANUFACTURING PROCESS FOR THE INSERT-MOLDED BOND PAD ARRAY COMPONENT.
P980035|S133|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|04/03/2009|||OK30|AUTOMATE THE MANUFACTURING PROCESS FOR THE INSERT-MOLDED BOND PAD ARRAY COMPONENT.
P980035|S134|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/2009|04/04/2011|||APPR|APPROVAL FOR THE ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR, MODEL 9995 APPLICATION SOFTWARE V7.3, CARELINK MONITOR MODEL 2490G UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
P890003|S169|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR & CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/2009|04/04/2011|||APPR|APPROVAL FOR THE ADVISA DR A4DR01 IMPLANTABLE  PULSE GENERATOR, MODEL 9995 APPLICATION SOFTWARE V7.3, CARELINK MONITOR MODEL 2490G UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
P010031|S150|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO CRT-D ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/2009|04/04/2011|||APPR|APPROVAL FOR THE ADVISA DR A4DR01 IMPLANTABLE  PULSE GENERATOR, MODEL 9995 APPLICATION SOFTWARE V7.3, CARELINK MONITOR MODEL 2490G UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
P980016|S187|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR, VIRTUOSO II DR/VR, MAXIMO II DR/VR ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/06/2009|04/04/2011|||APPR|APPROVAL FOR THE ADVISA DR A4DR01 IMPLANTABLE  PULSE GENERATOR, MODEL 9995 APPLICATION SOFTWARE V7.3, CARELINK MONITOR MODEL 2490G UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
P030031|S014|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/06/2009|08/12/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P990020|S034|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/06/2009|09/13/2011|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO INCORPORATE INFORMATION FROM COMPLETED CLINICAL STUDIES.
P970021|S026|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/2009|04/28/2009|||APPR|APPROVAL FOR REVISED PATIENT LABELING.
P020024|S024|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/06/2009|12/23/2010|||APPR|APPROVAL FOR UPDATES TO THE LABELING OF THE AMPLATZER DUCT OCCLUDER TO REFLECT THE FINDINGS OF THE POST APPROVAL STUDY.
P030026|S017|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|03/19/2009|||OK30|NEW AUTOMATED PROCEDURE FOR CONFIRMING THE VOLUME OF COATING SOLUTION DISPENSED INTO THE MICROTITER WELLS.
P010021|S015|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|03/19/2009|||OK30|NEW AUTOMATED PROCEDURE FOR CONFIRMING THE VOLUME OF COATING SOLUTION DISPENSED INTO THE MICROTITER WELLS.
P000044|S021|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|03/19/2009|||OK30|NEW AUTOMATED PROCEDURE FOR CONFIRMING THE VOLUME OF COATING SOLUTION DISPENSED INTO THE MICROTITER WELLS.
P030024|S011|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|03/19/2009|||OK30|NEW AUTOMATED PROCEDURE FOR CONFIRMING THE VOLUME OF COATING SOLUTION DISPENSED INTO THE MICROTITER WELLS.
P000014|S018|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|03/19/2009|||OK30|NEW AUTOMATED PROCEDURE FOR CONFIRMING THE VOLUME OF COATING SOLUTION DISPENSED INTO THE MICROTITER WELLS.
P950037|S070|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ICS 3000/EDP 30/CARDIOMESSENGER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|04/03/2009|||OK30|CHANGE IN MANUFACTURING LOCATION FOR EXTERNAL DEVICES TO ANOTHER LOCATION IN BERLIN, GERMANY.
P050023|S022|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIOMESSENGER TLINE/CARDIOMESSENGER II/CARDIOMESSENGER II-S|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2009|04/03/2009|||OK30|CHANGE IN MANUFACTURING LOCATION FOR EXTERNAL DEVICES TO ANOTHER LOCATION IN BERLIN, GERMANY.
P000053|S023|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICAL URINARY SPHINCTER (AUS)|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2009|04/08/2009|||OK30|USE OF AN ALTERNATE FLOW METER TO BE USED DURING THE TESTING OF THE DEVICES¿ CONTROL PUMP AND THE USE OF AN ALTERNATE DISINFECTANT CLEANER FOR SANITIZATION OF THE DEVICE TESTER.
P010020|S013|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON ARTIFICAL BOWEL SPHINCTER (ABS)|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2009|04/08/2009|||OK30|USE OF AN ALTERNATE FLOW METER TO BE USED DURING THE TESTING OF THE DEVICES¿ CONTROL PUMP AND THE USE OF AN ALTERNATE DISINFECTANT CLEANER FOR SANITIZATION OF THE DEVICE TESTER.
P810046|S228|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER RX CORONARY DILATATION CATHETER|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2009|04/06/2009|||APPR|APPROVAL TO RE-ESTABLISH THE TEMECULA, CALIFORNIA MANUFACTURING SITE FOR THE DEVICE.
P840001|S133|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREULTRA IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2009|04/08/2009|||OK30|ADDITION OF A HEADER REWORK PROCESS FOR THE DEVICE.
P050012|S018|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN SYSTEMS|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/09/2009|05/05/2009|||APPR|APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO PROVIDE ADDITIONAL SUPPLEMENTARY INFORMATION TO USERS ON GLUCOSE TRENDS AND PATTERNS DOWNLOADED TO THE PROGRAM.  THE SOFTWARE PROGRAM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DATA MANAGER 3 (DM3) AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS OR SEVEN SYSTEMS INTO A PERSONAL COMPUTER (PC).  THE SOFTWARE MODIFICATIONS INCLUDED SEVERAL NEW FEATURES AS IDENTIFIED IN THE SUBMISSION.
P020045|S026|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/2009|07/07/2009|||APPR|APPROVAL FOR A NEW CRYOABLATION CONSOLE WHICH INCLUDES CHANGES TO THE HARDWARE, SOFTWARE, USER INTERFACE, AND MECHANICAL CIRCUIT FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CRYOCONSOLE, 7F FREEZOR XTRA SURGICAL CATHETER AND CRYOCONSOLE, AND 9F FREEZOR MAX SURGICAL CATHETER AND CRYOCONSOLE.  THE NEW CRYOABLATION CONSOLE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYOCONSOLE TO BE USED WITH THE AFOREMENTIONED CATHETERS.
P040020|S014|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS|MFK|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2009|08/20/2009|||APPR|APPROVAL FOR CHANGES TO THE LABELING,REVISING THE DIRECTIONS FOR USE (DFU) AND PATIENT BROCHURE WITH UPDATED SIX-MONTHFOLLOW UP DATA FROM THE CLINICAL INVESTIGATION FOR THE LENSES. THE DEVICES, AS MODIFIEDWILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTOR INTRAOCULAR LENSES(IOLS) +3.0 D (MODELS: SN6AD1 AND MN6AD1) AND +4.0 D (MODELS: SN6AD3 ANDMN6AD3) ADD POWERS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTIONOF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUTPRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLEINDEPENDENCE. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P840062|S019|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING|LPG|DE|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2009|06/09/2009|||APPR|APPROVAL FOR AN ADDITIONAL TRADE NAME, ORAPLUG, TO THE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING.
P810002|S069|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MASTERS HP VALVED GRAFT WITH GELWEAVE VALSALVA TECHNOLOGY|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2009|04/23/2009|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, MINNEAPOLIS, MINNESOTA FOR ETHYLENE OXIDE (ETO) STERILIZATION.
P030040|S004|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA  CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2009|04/09/2009|||APPR|APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THE APPROVED DEVICE ADVIA CENTAUR HBC IGM ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETEDUNDER THE TRADE NAME ADVIA CENTAUR HBC IGM ASSAY AND IS INDICATED FOR:THE ADVIA CENTAUR HBC IGM ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION OF IGM RESPONSE TO HEPATITIS B VIRUS CORE ANTIGEN IN HUMAN SERUM ANDPLASMA (EDTA OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIACENTAUR XP SYSTEMS. THE ASSAY USES RECOMBINANT HBC ANTIGEN. THIS ASSAY MAY BE USED IN COMBINATION WITH OTHER HEPATITIS B VIRUS (HBV) MARKER ASSAYS TO DEFINE THE CLINICAL STATUS OF KNOWN HBV INFECTED PATIENTS OR CAN BE COMBINED WITH OTHER HBV. HAV (HEPATITIS AVIRUS), AND HCV (HEPATITIS C VIRUS) ASSAYS FOR THE DIAGNOSIS OF PATIENTS PRESENTING SYMPTOMS OF ACUTE VIRAL HEPATITIS.ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR IMMUNOCOMPRO-MISED ORIMMUNOSUPPRESSED PATIENTS, CORD BLOOD, NEONATAL SPECIMENS, INFANTS, OR CHILDREN.ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HBC IGM ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HBV SEROLOGICAL MARKERS.
P030049|S004|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2009|04/09/2009|||APPR|APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICES ADVIA CENTAUR HBSAG AND ADVIA HBSAG CONFIRMATORY ASSAY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBSAG READYPACKREAGENTS. ADVIA CENTAUR HBSAG READYPACK CONFIRMATORY ASSAY AND ADVIA CENTAUR HBSAGQUALITY CONTROL MATERIAL ARE INDICATED FOR:ADVIA CENTAUR HBSAG READYPACK REAGENTSTHE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B INFECTION.THIS PRODUCT IS NOT FOR USE FOR TESTING OR SCREENING POOLED SAMPLES CONTAINING SPECIMENS FROM MORE THAN ONE INDIVIDUAL, OR OTHERWISE IN BLOOD OR PLASMA SCREENING.ADVIA CENTAUR HBSAG READYPACK CONFIRMATORY ASSAY:THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAYFOR THE QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA. LITHIUM OR SODIUM HEPARIN) USING THEADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OF HBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIACENTAUR ASSAY.ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL:FOR MONITORING THE PERFORMANCE OF THE HBSAG AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS WHEN USING SERUM.
P030056|S004|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS|MZO|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2009|04/09/2009|||APPR|APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICE ADVIA CENTAUR HCV ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HCV ASSAY AND IS INDICATED FOR:ADVIA CENTAUR HCV ASSAY:THE ADVIA CENTAUR HCV ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEDETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARIN) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THE DIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS C INFECTION.ADVIA CENTAUR HCV QUALITY CONTROLS:FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HCV ASSAY ON THEADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HCV QUALITY CONTROL MATERIAL HAS NOTBEEN ESTABLISHED WITH ANY OTHER ANTI-HCV ASSAYS.
P040004|S004|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/TOTAL QUALITY CONTROL MATERIALS|LOM|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2009|04/09/2009|||APPR|APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICE ADVIA CENTAUR HBC TOTAL ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBC TOTAL ASSAY AND IS INDICATED FOR:THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION OF TOTAL ANTIBODIES TO THE CORE ANTIGEN OF THE HEPATITIS B VIRUS (HBC TOTAL)IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTIONAND IN THE DETERMINATION OF THE CLINICAL STATUS OF HBV INFECTED INDIVIDUALS IN CONJUNCTIONWITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. THIS ASSAY CAN ALSO BE USED AS AN AID IN THE DIFFERENTIALDIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY ISUNKNOWN.
P980022|S050|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK REAL-TIME TRANSMITTER & CGMS IPRO DIGITAL RECORDER|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2009|04/13/2009|||OK30|ADDITIONAL INSPECTION STEP DURING THE MANUFACTURE OF THE DEVICE.
P980022|S051|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR GLUCOSE SENSOR|MDS|CH|30-Day Notice||N|03/10/2009|04/08/2009|||OK30|MANUFACTURING PROCESS CHANGE TO REDUCE ERROR IN ACCEPTING OR REJECTING THE SENSOR.
P040024|S036|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE AND PERLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2009|04/06/2009|||OK30|CHANGE IN BULK AND FILLING PROCEDURES IN CONJUNCTION WITH THE MANUFACTURING OF THE DEVICE.
P000039|S030|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER 45 DELIVERY & EXCHANGE SYSTEMS|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2009|04/13/2009|||OK30|CHANGE IN MANUFACTURING EQUIPMENT USED TO SEAL THE POUCHES FOR THE DEVICE.
P020024|S025|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER 180 DELIVERY & EXCHANGE SYSTEMS|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2009|04/13/2009|||OK30|CHANGE IN MANUFACTURING EQUIPMENT USED TO SEAL THE POUCHES FOR THE DEVICE.
P990046|S020|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2009|03/24/2009|||OK30|ALTERNATE LOCATION FOR ASSEMBLY OF THE SEWING CUFF COMPONENT AT THE LAKE FOREST FACILITY.
P930038|S057|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2009|04/08/2009|||OK30|ALTERNATIVE LOT RELEASE MOISTURE SPECIFICATION ASSURANCE METHOD.
P840001|S134|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|30 CM SPECIFY 5-6-5 LEAD|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2009|05/20/2009|||APPR|APPROVAL FOR MANUFACTURING CHANGES TO THE SPECIFY 5-6-5 LEAD, MODEL 39565-30.
P050020|S012|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/13/2009|05/08/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSERTER COMPONENT HOUSING OF THE FREESTYLE CGMS, TO REDUCE THE OVERALL THICKNESS IN THE SHELVES OF THE HOUSING AND A CHANGE TO THE MANUFACTURING EQUIPMENT USED TO MOLD THE HOUSING COMPONENTS.
P960040|S191|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2009|03/31/2009|||OK30|SECOND SOURCE SUPPLIER FOR HEADERS.
P010012|S204|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2009|03/31/2009|||OK30|SECOND SOURCE SUPPLIER FOR HEADERS.
P990040|S008|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2009|04/28/2009|||OK30|CHANGE IN DOSE AUDIT FREQUENCY FOR THE STERILIZATION PROCEDURE.
P910077|S093|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE INDUCTIVE COMMUNICATOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2009|04/28/2009|||APPR|APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481, VERSION 1.5.
P000054|S021|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|MPW|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/2009|05/13/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE PACKAGE INSERTS.  SPECIFICALLY, ADDING TEXT TO ONE OF THE WARNINGS TO ADDRESS AES AND POTENTIAL SURGICAL INTERVENTIONS ASSOCIATED WITH IMPROPER USE OF THE RHBMP-2/ACS COMPONENTS OF THE PRODUCTS.
P000058|S032|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/2009|05/13/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE PACKAGE INSERTS.  SPECIFICALLY, ADDING TEXT TO ONE OF THE WARNINGS TO ADDRESS AES AND POTENTIAL SURGICAL INTERVENTIONS ASSOCIATED WITH IMPROPER USE OF THE RHBMP-2/ACS COMPONENTS OF THE PRODUCTS.
P010012|S205|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK & RENEWAL FAMILIES OF PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2009|04/28/2009|||APPR|APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481, VERSION 1.5.
P960040|S192|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM & VITALITY FAMILIES OF PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2009|04/28/2009|||APPR|APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481, VERSION 1.5.
P060010|S004|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2009|04/14/2009|||OK30|CHANGE IN SILICONE LUBRICATION AND THE ADDITION OF A COATING TO A SPANNER COMPONENT.
P980016|S188|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO ICD/VIRTUOSO II ICD/SECURA ICD/MAXIMO II ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2009|04/15/2009|||OK30|CHANGES TO THE HYBRID AND FINAL TEST FOR THE DEVICE.
P010031|S151|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2009|04/15/2009|||OK30|CHANGES TO THE HYBRID AND FINAL TEST FOR THE DEVICE.
P020045|S027|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES& CCT.2 CRYOCONSOLE SYSTE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2009|04/16/2009|||OK30|OUTSOURCING OF COMPONENTS.
P040024|S037|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE AND PERLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2009|04/08/2009|||OK30|CHANGES IN THE SUPPLIER OF 1.2 M HYDROCHLORIC ACID AND 0.25 M SODIUM HYDROXIDE SOLUTIONS.
P050006|S011|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2009|04/24/2009|||APPR|APPROVAL TO REMOVE A QUALITY CONTROL TEST FROM THE MANUFACTURING PROCESS FOR THE DEVICE.
P030039|S013|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT DEVICE|NBE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2009|09/03/2009|||APPR|APPROVAL FOR A NEW SUPPLIER OF PEG COMPONENT MATERIAL.
P030036|S013|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECT SECURE|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2009|04/28/2009|||APPR|APPROVAL FOR A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES.  THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED.
P010015|S067|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN OTW|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2009|04/28/2009|||APPR|APPROVAL FOR A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES.  THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED.
P830061|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE MODEL 4074 AND 4574|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2009|04/28/2009|||APPR|APPROVAL FOR A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES.  THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED.
P930039|S031|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS MODELS 4592 AND 4092|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2009|04/28/2009|||APPR|APPROVAL FOR A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES.  THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED.
P920015|S053|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO, SPRINT QUATTRO SECURE MODELS 6947 AND 6935|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2009|04/28/2009|||APPR|APPROVAL FOR A NEW KIT CONTAINING INDIVIDUALLY PACKAGED LEAD ANCHORING SLEEVES.  THE KIT WILL BE MARKETED UNDER THE TRADE NAME MODEL 5867 AS ANCHORING SLEEVE KIT AND IS INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE ENDOCARDIAL LEAD FAMILIES LISTED.
P040027|S014|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2009|04/07/2009|||OK30|EQUIPMENT MODIFICATION TO INCREASE THE CAPACITY AT AN IN-PROCESS WORK STEP.
P850079|S045|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY 55 UV (METHAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2009|04/15/2009|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER OF A RAW MATERIAL USE IN THE MANUFACTURING OF METHAFILCON A SOFT CONTACT LENSES.
P010012|S206|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2 LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2009|04/16/2009|||OK30|ACCEPTANCE OF CHANGES IN THE WELDING PROCESS PARAMETERS.
P010029|S008|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2009|10/11/2011|11M-0736|10/20/2011|APPR|APPROVAL FOR EUFLEXXA (1% SODIUM HYALURONATE). THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVENON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
P960013|S045|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD|NVN|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2009|04/16/2009|||APPR|APPROVAL FOR MINOR LABELING CHANGES THAT ENHANCE INSTRUCTIONS FOR SAFE DEVICE USE IN THE TENDRIL ST MODEL 1888 USER¿S MANUAL.
P040044|S012|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2009|04/15/2009|||APPR|APPROVAL FOR MODIFYING THE INSTRUCTIONS FOR USE TO INCLUDE THE USE OF 50% CONTRAST MEDIA / 50% SALINE SOLUTION FOR INFLATING THE BALLOON CATHETER.
P040001|S014|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM|NQO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2009|04/16/2009|||OK30|CHANGE OF ADHESIVE USED IN THE MANUFACTURING PROCESS OF THE DEVICE.
P060038|S003|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2009|03/25/2009|||OK30|IMPLEMENTATION OF AN AUTOMATED PARTS WASHER FOR THE DEVICE.
P050020|S013|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/20/2009|04/09/2009|||APPR|APPROVAL FOR AN UPDATED VERSION OF THE COPILOT HEALTH MANAGEMENT SYSTEM FOR FREESTYLE NAVIGATOR LABELING AND HELP FILES IN THE APPLICATION TO ADD WINDOWS VISTA AS AN OPERATING SYSTEM THAT THE APPLICATION CAN BE INSTALLED ON AS WELL AS ADDING THE NECESSARY STEPS TO ALLOW THE APPLICATION AND DEVICE TO BE USED WITH VISTA.
P860004|S106|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II INFUSION PUMP||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2009|04/16/2009|||OK30|MODIFICATION TO THE METHOD FOR TRANSFERRING TEST DATA FROM THE OVER PRESSURE MECHANISM IN-PROCESS TEST INTO FACTORY WORKS.
P810046|S229|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|POWERSAIL CORONARY DILATATION CATHETER|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2009|04/24/2009|||OK30|ADDITION OF VISUAL INSPECTION OF THE DISTAL SHAFT AND THE ADDITION OF A VERIFICATION OF IN-PROCESS MEASURING EQUIPMENT.
N17600|S024|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY PRODUCTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2009|04/17/2009|||OK30|CHANGES IN THE STERILIZATION VALIDATION METHOD.
P800002|S016|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY PRODUCTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2009|04/17/2009|||OK30|CHANGES IN THE STERILIZATION VALIDATION METHOD.
P020022|S007|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA 3.0 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|03/20/2009|04/14/2009|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE 440 SYSTEM SOFTWARE AND DMS SOFTWARE (RELEASE 3).
P010013|S022|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2009|09/15/2009|||APPR|APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX, NORTHBOROUGH, MASSACHUSETTS.
P030009|S034|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2009|04/07/2009|||OK30|REMOVAL OF DUPLICATE VISUAL INSPECTION ON THE PACKAGING.
P060033|S034|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2009|04/07/2009|||OK30|REMOVAL OF DUPLICATE VISUAL INSPECTION ON THE PACKAGING.
P030054|S120|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE/PROMOTE + CRT-D|NIK|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/23/2009|04/16/2009|||APPR|APPROVAL TO EXTEND THE SHELF LIFE OF THE DEVICE.
P910023|S204|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/23/2009|04/16/2009|||APPR|APPROVAL TO EXTEND THE SHELF LIFE OF THE DEVICE.
P050023|S023|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIOMESSENGER II-S (TLINE) SOFTWARE VERSION 1.20, CARDIOMESSENGER LLT, CARDIOMESSENGER TLINE; CARDIOMESSENGER II|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2009|04/16/2009|||APPR|APPROVAL FOR THE REMOVAL OF THE DIAL-IN PREFIXES IN THE DEVICE.
P950037|S071|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PULSE GENERATORS PHILOS II DR-T/CYLOS DR-T|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2009|04/16/2009|||APPR|APPROVAL FOR THE REMOVAL OF THE DIAL-IN PREFIXES IN THE DEVICE.
P860057|S055|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES HEART VALVES|DYE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2009|12/11/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SINGAPORE PTE. LTD., SINGAPORE, CHINA.
P040024|S038|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2009|04/23/2009|||OK30|CHANGE IN THE VOLUME FOR DELIVERY OF THE DEVICE.
P000058|S033|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2009|10/21/2009|||APPR|APPROVAL FOR A CHANGE TO THE KITTING AND STORAGE LOCATION FOR INFUSE® BONE GRAFT AND IS INDICATED FOR TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT, AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS, AND FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE AT ONE LEVEL FROM L4-S1.
P000054|S022|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2009|10/21/2009|||APPR|APPROVAL FOR A CHANGE TO THE KITTING AND STORAGE LOCATION FOR INFUSE® BONE GRAFT AND IS INDICATED FOR TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT, AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS, AND FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE AT ONE LEVEL FROM L4-S1.
P050053|S012|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2009|10/21/2009|||APPR|APPROVAL FOR A CHANGE TO THE KITTING AND STORAGE LOCATION FOR INFUSE® BONE GRAFT AND IS INDICATED FOR TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT, AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS, AND FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE AT ONE LEVEL FROM L4-S1.
P980016|S189|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/VIRTUOSO/MAXIMO II/SECURA/MARQUIS/MAXIMO/INTRINSIC 35J/30/VIRTUOSO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2009|04/22/2009|||OK30|CHANGE IN MANUFACTURING PROCESS FOR CAPACITOR.
P010031|S152|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC FAMILIES OF ICDS/CONSULTA CRT-D/CONCERTO ICD/MAXIMO II CRT-D/CONCERTO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2009|04/22/2009|||OK30|CHANGE IN MANUFACTURING PROCESS FOR CAPACITOR.
P980022|S052|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MMT-7335 CARELINK PRO PC SOFTWARE|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2009|05/22/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE CARELINK PRO PC SOFTWARE (VERSION 1.3A, MMT-7335) TO CORRECT TWO IDENTIFIED PROBLEMS.
P030047|S017|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2009|04/22/2009|||OK30|MODIFICATIONS TO THE DELIVERY SYSTEM BONDING PROCESS.
P020036|S013|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2009|04/22/2009|||OK30|MODIFICATIONS TO THE DELIVERY SYSTEM BONDING PROCESS.
P950009|S009|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT SYSTEM|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2009|07/24/2009|||APPR|APPROVAL FOR DESIGN CHANGES TO THE IMAGE, CAPTURE AND FOCUS (ICF) CIRCUIT BOARD IN THE BD FOCALPOINT PROFILER.
P920015|S054|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF PACEMAKERS/ DEFIBRILLATORS/ CRTS|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2009|05/14/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CENTER (MPROC) IN VILLALBA, PUERTO RICO AS AN ALTERNATE MANUFACTURER FOR THE DEVICE.
P960058|S080|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/2009|06/11/2010|||APPR|APPROVAL FOR THE ADDITION OF A MOISTURE GETTER MATERIAL IN THE HIRES90KL COCHLEAR IMPLANT AS A PREVENTIVE MEASURE IN THE UNLIKELY EVENT OF A HERMETIC FAILURE.
P040021|S008|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|SJM BIOCOR/BIOCOR SUPRA VALVES|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/27/2009|05/04/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980035|S136|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG FAMILY|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/2009|06/24/2009|||APPR|APPROVAL FOR VERSION 7.1 OF THE MODEL 9987 APPLICATION SOFTWARE WHICH RESETS THE ERI VOLTAGE THRESHOLD TO COMPENSATE FOR THE POTENTIAL PREMATURE LITHIUM DEPLETION.
P980016|S191|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/2009|06/24/2009|||APPR|APPROVAL FOR VERSION 7.1 OF THE MODEL 9987 APPLICATION SOFTWARE WHICH RESETS THE ERI VOLTAGE THRESHOLD TO COMPENSATE FOR THE POTENTIAL PREMATURE LITHIUM DEPLETION.
P870024|S046|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens,contact(rigid gas permeable)-extended wear|PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON C) AND PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON B)|MWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/29/2009|||OK30|CHANGE IN THE MANUFACTURING MATERIALS.
P860019|S232|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX PTCA DILATION CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|02/01/2010|||APPR|APPROVAL TO MODIFY THE SAMPLING FREQUENCIES AND ACCEPTANCE LIMITS ASSOCIATED WITH DESTRUCTIVE TESTS.
P040016|S035|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/08/2009|||OK30|CHANGE FROM A SEMI-AUTOMATED IN-PROCESS INSPECTION OF THE GUIDE WIRE PORT BOND TO AN AUTOMATED IN-PROCESS INSPECTION.
P030025|S063|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/08/2009|||OK30|CHANGE FROM A SEMI-AUTOMATED IN-PROCESS INSPECTION OF THE GUIDE WIRE PORT BOND TO AN AUTOMATED IN-PROCESS INSPECTION.
P020009|S049|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/08/2009|||OK30|CHANGE FROM A SEMI-AUTOMATED IN-PROCESS INSPECTION OF THE GUIDE WIRE PORT BOND TO AN AUTOMATED IN-PROCESS INSPECTION.
P860019|S233|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM MAVERICK PTCA /MAVERICK2 PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/08/2009|||OK30|CHANGE FROM A SEMI-AUTOMATED IN-PROCESS INSPECTION OF THE GUIDE WIRE PORT BOND TO AN AUTOMATED IN-PROCESS INSPECTION.
P060008|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/08/2009|||OK30|CHANGE FROM A SEMI-AUTOMATED IN-PROCESS INSPECTION OF THE GUIDE WIRE PORT BOND TO AN AUTOMATED IN-PROCESS INSPECTION.
P980016|S192|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO VR/DR/MARQUIS VR/DR/INTRINSIC/VIRTUOSO/ENTRUST/SECURA DR/VR/MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/24/2009|||OK30|CHANGE IN THE TYPE OF CURING OVEN.
P010021|S016|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/2009|07/15/2009|||APPR|APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE ANTI-HCV ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR AND ISINDICATED FOR:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK:FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING THE VITROSECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THEVITROS 5600 INTEGRATED SYSTEM. THREE RECOMBINANT HEPATITIS C VIRUS ENCODED ANTIGENS ARE USED.ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HEPATITIS C VIRUS, (STATE OR ASSOCIATED DISEASE NOT DETERMINED), IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FORHEPATITIS C INFECTION. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS C INFECTION INPREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HCV DURING THE PRENATALPERIOD.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE IN VITROQUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING VITROS ANTI-HCV REAGENT PACKS.THE VITROS ANTI-HCV CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQIMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK.
P010031|S153|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC II/III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/24/2009|||OK30|CHANGE IN THE TYPE OF CURING OVEN.
P910023|S205|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|SJM IMPLANTABLE ICDS & CRT-DS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/28/2009|||OK30|ADDITION OF A FLEX CIRCUIT SUPPLIER.
P030054|S121|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE / PROMOTE+ CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2009|04/28/2009|||OK30|ADDITION OF A FLEX CIRCUIT SUPPLIER.
P070007|S009|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2009|04/22/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING.
P950029|S044|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY SR/DR/RHAPSODY SR/DR/REPLY VR/DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2009|05/01/2009|||OK30|IMPROVEMENT IN MANUFACTURING BAL SEAL VERIFICATION.
P980049|S047|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2009|05/01/2009|||OK30|IMPROVEMENT IN MANUFACTURING BAL SEAL VERIFICATION.
P060027|S013|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2009|05/01/2009|||OK30|IMPROVEMENT IN MANUFACTURING BAL SEAL VERIFICATION.
P960013|S046|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL STS LEAD MODEL 2088TC|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/31/2009|05/26/2009|||APPR|APPROVAL FOR DISTAL TIP CHANGES TO THE TENDRIL ST MODEL 1888 LEAD FAMILY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TENDRIL STS MODEL 2088TC, AND ARE TRANSVENOUS STEROID ELUTING LEADS INDICATED FOR USE IN THE RIGHT ATRIUM OR RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
P000039|S031|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/31/2009|05/12/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000020|S012|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS AND TEMPLINK EXTENSION CABLES|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/31/2009|04/21/2009|||APPR|APPROVAL FOR USE OF THE STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS WITH THE BOSTON SCIENTIFIC MAESTRO 3000, EPT-1000XP, AND IRVINE BIOMEDICAL IBI-1500 T9 AND IBI-150 T6 RF GENERATORS.
P030029|S006|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI - HBS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2009|08/20/2009|||APPR|APPROVAL FOT THE ADVIA CENTAUR SYSTEM SOFTWARE VERSION 4.0.
P030049|S005|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG (HBS) AND HBSAG CONFIRMATORY|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2009|08/20/2009|||APPR|APPROVAL FOT THE ADVIA CENTAUR SYSTEM SOFTWARE VERSION 4.0.
P030040|S005|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBC IGM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2009|08/20/2009|||APPR|APPROVAL FOT THE ADVIA CENTAUR SYSTEM SOFTWARE VERSION 4.0.
P040004|S005|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HBCT|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2009|08/20/2009|||APPR|APPROVAL FOT THE ADVIA CENTAUR SYSTEM SOFTWARE VERSION 4.0.
P030056|S005|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI-HCV|MZO|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2009|08/20/2009|||APPR|APPROVAL FOT THE ADVIA CENTAUR SYSTEM SOFTWARE VERSION 4.0.
P990018|S004|MENICON CO. LTD.|269 A BALLARDVALE STREET||WILMINGTON|MA|01887||Lens,contact(rigid gas permeable)-extended wear|MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS|MWL|OP|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/01/2009|02/25/2010|||APPR|APPROVAL FOR MODIFIED LABELING TO INCLUDE INFORMATION REGARDING THE POST-APPROVAL STUDY.
P810046|S230|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER NC CORONARY DILATATION CATHETER|MAF|CV|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|04/01/2009|07/15/2009|||APPR|APPROVAL TO MODIFY THE PROTECTIVE BALLOON SHEATH.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VOYAGER NC CORONARY DILATATION CATHETER AND IS INDICATED FOR: 1) BALLOON DILATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; 2) BALLOON DILATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION; AND 3) BALLOON DILATION OF A STENT AFTER IMPLANTATION.
P960042|S012|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH (SLS)|MFA|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2009|11/05/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, LLC, SALT LAKE CITY, UTAH FOR STERILIZATION PACKAGING.
P860004|S107|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED INFUSION SYSTEM||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2009|05/01/2009|||OK30|CHANGES TO THE PUMP TUBE COMPONENT OF THE DEVICE.
P030006|S022|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2009|11/23/2009|||APPR|APPROVAL FOR SPECIFIC MODIFICATIONS TO THE TREATMENT CATHETER DESIGN, CATHETER MANUFACTURING PROCESSES, AND CATHETER SPECIFICATIONS.
P040020|S015|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR IOLS +3.0 D & +4.0 D ADD POWERS|MFK|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2009|05/28/2009|||APPR|APPROVAL FOR AN EXPANSION OF THE DIOPTRIC RANGE TO INCLUDE 6.0 TO 9.5 DIOPTERS IN ½ DIOPTER INCREMENTS FOR MODELS SN6AD1, MN6AD1 AND SN6AD3.
P010032|S029|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON NEUROSTIMULATION (IPG), ANS EON C NEUROSTIMULATION (IPG), AND EON MINI NEUROSTIMULATION(IPG)|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2009|06/01/2009|||APPR|APPROVAL FOR PENTA LEAD KITS (MODELS 3227, 3228, 3229, 3230, 3231, 3232, 3233, AND 3234).
P910023|S206|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2009|05/07/2009|||APPR|APPROVAL FOR:1) REPLACING THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITHPLUG/RECEPTACLE CONNECTORS, EPOXY, DIRECT SOLDER OR LASER WELDING.2) USING AN ORGANIC SUBSTRATE FOR THE HYBRID MODULE.3) RECONFIGURING DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS (E.G. HV CONVERTER BOARDASSEMBLY, SENSOR SUPPORT ASSEMBLY) TO INTEGRATE THEM INTO THE HYBRID.
P030054|S122|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2009|05/07/2009|||APPR|APPROVAL FOR:1) REPLACING THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITHPLUG/RECEPTACLE CONNECTORS, EPOXY, DIRECT SOLDER OR LASER WELDING.2) USING AN ORGANIC SUBSTRATE FOR THE HYBRID MODULE.3) RECONFIGURING DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS (E.G. HV CONVERTER BOARDASSEMBLY, SENSOR SUPPORT ASSEMBLY) TO INTEGRATE THEM INTO THE HYBRID.
P010055|S005|PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|CORETHERM SYSTEM MICROWAVE THERMOTHERAPY|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2009|05/21/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY, WIESBADEN, GERMANY.
P010055|S006|PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|CORETHERM SYSTEM MICROWAVE THERMOTHERAPY|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2009|06/08/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CENOVA INNOVATION AND PRODUCTION AB IN MJOLBY, SWEDEN, WHERE CATHETER PACKAGING WILL BE PERFORMED.
P020026|S061|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2009|07/23/2009|||APPR|APPROVAL FOR AN ALTERNATE QUALITY CONTROL TEST METHOD.
P000029|S055|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2009|05/05/2009|||OK30|USE OF TWO NEW TEST METHODS FOR THE DETERMINATION OF TWO CHEMICAL ENTITIES IN THE GEL.
P000021|S014|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2009|06/04/2009|||APPR|APPROVAL FOR THE USE OF THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEMS (AMAS) (ADVIA LABCELL AND ADVIA WORKCELL).
P830055|S110|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2009|05/06/2009|||OK30|USE OF TWO NEW AUTOMATED CLEAN LINES TO REPLACE THE EXISTING AUTOMATED CLEANING SYSTEM USED TO REMOVE MANUFACTURING MATERIALS.
P070016|S004|WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 TAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2009|05/21/2009|||APPR|APPROVAL FOR MINOR CHANGES TO THE PROXIMAL TRIGGER-WIRE ATTACHMENT AND TAPERED SECTION OF THE PUSHER.
P920047|S039|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER PRIME HTD CARDIAC ABLATION CATHETERS|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2009|10/02/2009|||APPR|APPROVAL FOR CHANGES IN THE STEERING SUBASSEMBLY CENTER SUPPORT AND LEAF SPRINGS, DISTAL TUBING, ADDITION OF A STIFFENING ELEMENT TO THE PROXIMAL SHAFT, MINOR LABELING CHANGES, AND PACKAGING CHANGES, AND THE ADDITION OF A STERILIZATION FACILITY, STERIS ISOMEDIX CORPORATION, SOUTH PLAINFIELD, NEW JERSEY.
P020025|S020|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP CARDIAC ABLATION CATHETERS|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/06/2009|10/02/2009|||APPR|APPROVAL FOR CHANGES IN THE STEERING SUBASSEMBLY CENTER SUPPORT AND LEAF SPRINGS, DISTAL TUBING, ADDITION OF A STIFFENING ELEMENT TO THE PROXIMAL SHAFT, MINOR LABELING CHANGES, AND PACKAGING CHANGES, AND THE ADDITION OF A STERILIZATION FACILITY, STERIS ISOMEDIX CORPORATION, SOUTH PLAINFIELD, NEW JERSEY.
P010015|S068|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE LEAD|OJX|CV|Real-Time Process||N|04/06/2009|06/05/2009|||APPR|APPROVAL FOR A CHANGE TO THE DC RESISTANCE SPECIFICATION FOR THE MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE (OTW) LEAD FAMILY.
P060008|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2009|05/07/2009|||OK30|ADDITION OF AN INTRA-CAMPUS MANUFACTURING SITE INCORPORATING THE SPECIFIED PROCESS CHANGES.
P900023|S051|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|IPULSE CIRCULATORY SUPPORT SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/07/2009|06/05/2009|||APPR|APPROVAL FOR AN INCREASED FIELD SERVICE INTERVAL OF 5000 HOURS FOR THE IPULSE CONSOLE.
P840001|S135|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 3550-39 TITAN ANCHOR|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2009|09/02/2009|||APPR|APPROVAL FOR: 1) REMOVAL OF THE XYLENE MIXING STEP; 2) ADDITION OF A SECONDARY SILICONE ADHESIVE STEP AND CURE; AND 3) MODIFICATION OF THE INCOMING RECEIVING INSPECTION PROCESS WITH THE ADDITION OF A PROCESS MONITOR.
P910023|S207|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/08/2009|04/30/2009|||APPR|APPROVAL FOR ENHANCEMENTS TO THE SOFTWARE (VERSION 4.0) USED IN THE ST. JUDE MEDICAL MERLIN.NET SYSTEM.
P010013|S023|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/08/2009|05/08/2009|||APPR|APPROVAL FOR CHANGES INTENDED TO IMPROVE THE INSTRUCTIONS FOR USE IN REGARD TO SAFE REMOVAL OF THE NOVASURE DEVICE FOLLOWING TREATMENT.
P910023|S208|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/08/2009|04/28/2009|||APPR|APPROVAL FOR THE MODEL EX2000 V.4.0 VERSION SOFTWARE FOR USE ON THE ST. JUDE MEDICAL MERLIN@HOME DEVICES.
P030054|S123|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/08/2009|04/28/2009|||APPR|APPROVAL FOR THE MODEL EX2000 V.4.0 VERSION SOFTWARE FOR USE ON THE ST. JUDE MEDICAL MERLIN@HOME DEVICES.
P940015|S015|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC|MOZ|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/2009|08/20/2009|||APPR|APPROVAL FOR LABELING CHANGES TO THE PRODUCT LEAFLET/PACKAGE INSERT FOR SYNVISC TO MAINTAIN CONSISTENCY WITH WORDING PREVIOUSLY APPROVED FOR SYNVISC-ONE PACKAGE INSERTS.
P980049|S048|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2009|05/08/2009|||OK30|CHANGE IN THE GLUE BARRIER DISPOSAL PROCESS.
P060027|S014|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2009|05/08/2009|||OK30|CHANGE IN THE GLUE BARRIER DISPOSAL PROCESS.
P080006|S001|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2009|05/08/2009|||OK30|MODIFICATION OF THE ACCEPTANCE CRITERIA OF THE ETHYLENE OXIDE STERILIZATION MANUFACTURING PROCESS AT THE MPROC-VILLALBA FACILITY.
P020036|S014|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. NITINOL STENT SYSTEM AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2009|04/22/2009|||OK30|ADDITION OF AN IN-PROCESS STENT RECOVERY STEP DURING THE FINAL ASSEMBLY PROCESS.
P950032|S051|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/2009|05/19/2009|||APPR|APPROVAL FOR A NEW CELL STRAIN, HEP 016, FOR INTRODUCTION INTO PRODUCTION OF APLIGRAF.
P840001|S136|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF NEUROSTIMULATION DEVICES|LGW|NE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2009|06/08/2009|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE TORQUE WRENCH AND STYLET ACCESSORIES.
P020022|S008|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|30-Day Notice||N|04/10/2009|05/01/2009|||OK30|ADDITION OF AN INCOMING QUALITY CONTROL STEP.
P950021|S011|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ADVIA CENTAUR XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)|MTF|IM|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/2009|06/10/2009|||APPR|APPROVAL FOR THE ADDITION OF THE ADVIA CENTAUR XP INSTRUMENT (WITH VERSION 5.0SOFTWARE) TO THE INSTRUMENT(S) USING THE ADVIA CENTAUR PSA ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR AND ADVIA CENTAUR XP PSA ASSAY AND ISINDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER.
P990055|S012|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)|NAF|IM|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/2009|06/10/2009|||APPR|APPROVAL FOR THE ADDITION OF THE ADVIA CENTAUR XP INSTRUMENT (WITH VERSION 5.0SOFTWARE) TO THE INSTRUMENT(S) USING THE ADVIA CENTAUR CPSA ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR AND ADVIA CENTAUR XP CPSA ASSAY AND ISINDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER.
P040037|S018|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2009|04/24/2009|||OK30|ADDITION OF AN AUTOMATED METHOD OF REMOVING THE MANDREL FROM THE ENDOPROSTHESIS.
P860019|S234|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2009|09/18/2009|||APPR|APPROVAL FOR CHANGES TO THE SILICONE MATERIAL.
P020026|S063|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2009|05/06/2009|||OK30|CHANGE TO AN ACCEPTANCE CRITERION FOR AN IN-PROCESS ACCEPTANCE ACTIVITY.
P930039|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice||N|04/10/2009|05/08/2009|||OK30|CHANGE IN THE CONNECTOR SLEEVE SUPPLIER.
P890003|S171|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD LEAD|NVZ|CV|30-Day Notice||N|04/10/2009|05/08/2009|||OK30|CHANGE IN THE CONNECTOR SLEEVE SUPPLIER.
P980016|S193|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2009|05/08/2009|||OK30|CHANGES TO THE DEVICE FUNCTIONAL TEST SOFTWARE.
P010031|S154|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2009|05/08/2009|||OK30|CHANGES TO THE DEVICE FUNCTIONAL TEST SOFTWARE.
P060008|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2009|05/22/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN PLYMOUTH, MINNESOTA, FOR THE MANUFACTURE OF SIBS POLYMER.
P070015|S015|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2009|05/08/2009|||OK30|EXTENSION OF THE RETEST DATE FOR ONE OF THE POLYMERS USED IN THE MANUFACTURE OF THE DEVICE.
P010025|S016|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2009|05/01/2009|||OK30|CHANGE TO THE COMPUTER HOUSING.
P960009|S065|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION (DBS)|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/2009|05/07/2009|||APPR|APPROVAL FOR LABELING CHANGES FOR THE ACTIVA DBS LEAD MODELS 3387, 3389, 3387(S), AND 3389(S).
P040044|S013|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2009|04/28/2009|||OK30|USE OF AN ADHESIVE PRIMER TO ETCH THE INTERIOR OF THE BALLOON LEGS.
P040044|S014|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/2009|05/12/2009|||APPR|APPROVAL FOR CHANGES TO THE PATIENT BROCHURE.
P960009|S066|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA RC/PC IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2009|04/30/2009|||OK30|CHANGE TO AUTOMATE A MANUFACTURING PROCESS AND THE ADDITION OF VISUAL INSPECTIONS DURING THE PROCESS.
P840001|S137|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2009|04/30/2009|||OK30|CHANGE TO AUTOMATE A MANUFACTURING PROCESS AND THE ADDITION OF VISUAL INSPECTIONS DURING THE PROCESS.
P970004|S072|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2009|04/30/2009|||OK30|CHANGE TO AUTOMATE A MANUFACTURING PROCESS AND THE ADDITION OF VISUAL INSPECTIONS DURING THE PROCESS.
P950005|S026|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2009|05/13/2009|||OK30|REMOVAL OF AN INSPECTION STEP.
P990025|S018|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2009|05/13/2009|||OK30|REMOVAL OF AN INSPECTION STEP.
P010068|S014|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2009|05/13/2009|||OK30|REMOVAL OF AN INSPECTION STEP.
P030032|S008|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL)|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/15/2009|02/24/2010|||APPR|APPROVAL FOR A LABELING UPDATE TO CAPTIQUE AS A FOLLOW-UP TO THE POST-APPROVAL STUDY.
P810002|S070|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MASTERS VALVED GRAFT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2009|04/30/2009|||OK30|CHANGE TO THE METHOD OF RADIATION STERILIZATION DOSE AUDITS.
P930038|S058|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2009|05/07/2009|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE EVOLUTION ASSEMBLY.
P960009|S067|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVARC AND ACTIVAPC|MHY|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/2009|06/08/2009|||APPR|APPROVAL FOR MODEL 64001 (1X4) POCKET ADAPTOR AND MODEL 64002 (2X4) POCKET ADAPTOR.
P000013|S009|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|OSTEONICS ABC/TRIDENT SYSTEMS|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/16/2009|05/07/2009|||APPR|APPROVAL FOR CHANGES TO THE LABELING (I.E., SURGICAL PROTOCOL) OF THE TRIDENT HIP SYSTEM.  THESE MODIFICATIONS INCLUDE CREATING SEPARATE AND DISTINCT SURGICAL PROTOCOLS, ONE FOR THE TRIDENT PSL SHELL AND ONE FOR THE TRIDENT HEMISPHERICAL SHELL, IN ORDER TO CLARIFY THE DIFFERENCES IN REAMING TECHNIQUES BETWEEN THE TWO SHELLS, AS WELL AS OTHER IMPROVEMENTS TO THE SURGICAL PROTOCOL.
P040024|S039|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE L  AND PERLANE L INJECTABLE GELS|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2009|01/29/2010|||APPR|APPROVAL FOR THE ADDITION OF 0.3% LIDOCAINE INTO RESTYLANE AND PERLANE. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RESTYLANE-L AND PERLANE-L AND ISINDICATED FOR MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS; AND FOR IMPLANTATION INTO THE DEEP DERMIS TOSUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH ASNASOLABIAL FOLDS, RESPECTIVELY.
P040033|S011|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2009|06/09/2009|||APPR|APPROVAL FOR THE MODIFICATION OF THE BHR/R3 MODULAR RESURFACING SURGICAL TECHNIQUE ADDENDUM.
P990009|S026|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2009|05/04/2009|||APPR|APPROVAL FOR INCLUSION OF TWO ADDITIONAL PRODUCT APPLICATOR TIPS TOGETHER AS PART OF THE FLOWSEAL HEMOSTATIC MATRIX KIT OR PACKAGED INDIVIDUALLY.
P960040|S193|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN FAMILY|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2009|05/26/2009|||APPR|APPROVAL FOR THE PROGRAMMER SW MODEL 2868 V1.05 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES.
P010012|S207|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2009|05/26/2009|||APPR|APPROVAL FOR THE PROGRAMMER SW MODEL 2868 V1.05 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES.
P860019|S235|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX PTCA BALLOON DILATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2009|05/13/2009|||OK30|CHANGE TO THE SUPPLIER OF THE OVER-THE-WIRE MANIFOLD COMPONENT.
P040045|S004|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2009|05/13/2009|||OK30|USE OF AN ALTERNATE FINISHED PRODUCT RELEASE TEST METHOD.
N18033|S041|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|HEMA FOR VISTAKON (ETAFILCON A) SOFT HYDROPHILIC CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2009|05/20/2009|||OK30|CHANGE TO IMPLEMENT AN ALTERNATE SUPPLIER FOR THE CRITICAL MATERIAL, HEMA, USED IN THE PRODUCTION OF THE DEVICE.
P060040|S005|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/2009|01/20/2010|10M-0078|02/22/2010|APPR|APPROVAL FOR THE THORATEC HEARTMATE II LVAS.  THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NON-REVERSIBLE LEFT VENTRICULAR FAILURE.  IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION (NYHA) CLASS IIIB OR IV END-STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 45 OF THE LAST 60 DAYS, AND ARE NOT CANDIDATES FOR CARDIAC TRANSPLANTATION.  THE HEARTMATE II LVAS IS INTENDED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL, OR FOR TRANSPORTATION OF VENTRICULAR ASSIST DEVICE PATIENTS VIA GROUND AMBULANCE, FIXED-WING AIRCRAFT, OR HELICOPTER.
P840001|S138|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 3550-31 SNAP-LID SCREENING CONNECTOR CABLE|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2009|06/18/2009|||OK30|CHANGES TO THE MANUFACTURING PROCESS OF THE SCREENING CONNECTOR CABLE.
P060037|S008|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2009|05/08/2009|||OK30|CHANGES IN THE PACKAGING CLEAN ROOM FOR THE DEVICE.
P060010|S005|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2009|05/19/2009|||APPR|APPROVAL FOR THE ADDITION OF AN IN-PROCESS INFLATION TEST FOR THE INSERTION TOOL.
P960040|S194|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY/CONFIENT FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2009|05/21/2009|||OK30|CHANGE IN THE INCOMING LOT ACCEPTANCE TESTING AND CRITERIA FOR THIN-FILM RESISTOR COMPONENTS.
P010012|S208|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL/LIVIAN FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2009|05/21/2009|||OK30|CHANGE IN THE INCOMING LOT ACCEPTANCE TESTING AND CRITERIA FOR THIN-FILM RESISTOR COMPONENTS.
P030005|S057|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|RENEWAL TR FAMILY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2009|05/21/2009|||OK30|CHANGE IN THE INCOMING LOT ACCEPTANCE TESTING AND CRITERIA FOR THIN-FILM RESISTOR COMPONENTS.
P000025|S041|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2009|09/03/2009|||APPR|APPROVAL FOR THE ADDITION OF A SECOND SOURCE SUPPLIER FOR THE FEEDTHROUGH ASSEMBLY.
P990046|S021|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS MEDICAL OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2009|05/12/2009|||OK30|ADDITIONAL CNC GRINDER.
P910065|S007|TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ST AIA-PACK PA|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/2009|11/30/2009|||APPR|APPROVAL FOR ADDING THE ASSAY OF TOSOH ST AIA-PACK. PSA (PROSTATE SPECIFIC ANTIGEN) TO THE TOSOH A1A-2000 ST/LA INSTRUMENT, AND EXTENSION OF THE CALIBRATION CURVESTABILITY FOR THE ST AIA-PACK PA PSA ASSAY FROM 60 DAYS TO 90 DAYS FOR AIA NEX.IA, AIA-600 II, AIA-360, AIA-1800, AND AIA-2000.
P900056|S096|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2009|05/22/2009|||OK30|MODIFICATIONS TO THE DRAWING SPECIFICATIONS FOR THE ROTAWIRE GUIDEWIRE.
P060037|S009|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEMS|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/24/2009|11/03/2010|||APPR|APPROVAL FOR THE ADDITION OF PROLONG HIGHLY CROSSLINKED POLYETHYLENE TIBIAL ARTICULAR SURFACES TO THE NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM.
P060010|S006|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2009|05/27/2009|||OK30|CHANGE TO THE COSMETICS OF A SPANNER COMPONENT.
P000029|S056|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2009|05/27/2009|||OK30|USE OF A NEW INCOMING IDENTIFICATION TEST METHOD FOR A CHEMICAL ENTITY IN THE GEL AS WELL AS A NEW TESTING FACILITY FOR THIS IDENTIFICATION TEST METHOD.
P980037|S030|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2009|06/24/2009|||APPR|APPROVAL FOR A CHANGE TO THE ANGIOJET ULTRA CONSOLE BAR CODE READER.
P060030|S003|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2009|05/22/2009|||OK30|CHANGE OF FUNCTIONAL RELEASE TESTING OF BULK MAGNETIC GLASS PARTICLES (MGP), PROTEINASE (PASE), ELUTION BUFFER (EB), AND LYSIS BUFFER (LB) FOR THE DEVICE.
P060010|S007|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2009|06/26/2009|||APPR|APPROVAL FOR MODIFICATION OF THE SPANNER PROXIMAL TUBE ASSEMBLY TO REPLACE THE STAINLESS STEEL COIL WITH A HIGH DUROMETER SILICONE SLEEVE.
P080010|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS|MFK|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2009|06/19/2009|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.
P860003|S053|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX* PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2009|05/27/2009|||OK30|CHANGE TO PERFORM FINAL PRODUCT TESTING ON CELLEX PROCEDURAL KITS AT A CONTRACT MANUFACTURER.
P970004|S073|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/2009|10/26/2009|||APPR|APPROVAL FOR CHANGES TO THE EXISTING MODEL 3093 AND MODEL 3889 INTERSTIM TINED LEADS, THE ADDITION OF AN ALTERNATIVE STYLET DESIGN TO BE INCLUDED IN THE MODEL 3093 AND MODEL 3889 LEADS KITS, AND A MINOR REVISION TO THE LABELING TO UPDATE THE LIST OF PACKAGE CONTENTS FOR THE MODEL 3093 AND MODEL 3889 LEADS KITS.
P010012|S209|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-DS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/30/2009|06/12/2009|||APPR|APPROVAL FOR THE RF MODULE CHANGES FOR COGNIS/TELIGEN MODELS E102, E110, N108, N118, AND N119.
P070015|S016|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2009|05/29/2009|||OK30|MODIFICATIONS OT THE PARTICULATE TESTING.
P960040|S195|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/30/2009|06/12/2009|||APPR|APPROVAL FOR THE RF MODULE CHANGES FOR COGNIS/TELIGEN MODELS E102, E110, N108, N118, AND N119.
P010012|S210|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2009|06/03/2009|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER FOR THE CRYSTAL QUARTZ.
P960040|S196|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2009|06/03/2009|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER FOR THE CRYSTAL QUARTZ.
P860057|S056|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS|DYE|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2009|07/09/2009|||APPR|APPROVAL FOR A NEW DEVICE TRADE NAME AND MODEL NUMBER TO ADD TO THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS FAMILY.  MODEL 7200TFX IS IDENTICAL TO THE PREVIOUSLY APPROVED MODEL 7000TFX WITH THE EXCEPTION OF A DIFFERENT SIZING CONVENTION.  THERE ARE NO CHANGES TO THE DIMENSIONS OF THE DEVICE OR THE INDICATIONS FOR USE.  THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISMODEL 7200TFX AND IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING  NATIVE OR PROSTHETIC MITRAL VALVES.
P030002|S019|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL)|NAA|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2009|06/30/2009|||APPR|APPROVAL TO MODIFY THE PHYSICIAN¿S LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE CRYSTALENS MODEL HD500 AND HD520 AS FOLLOWS: THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR MODEL HD500 LENSES IN THE +18 TO +22 DIOPTRIC POWER RANGE AND FOR MODEL HD520 LENSES IN THE +16.25 TO +16.75 DIOPTRIC POWER RANGE.
P070015|S017|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2009|07/09/2009|||APPR|APPROVAL FOR THE ADDITION OF SEVERAL TEST METHODS FOR AN EXCIPIENT USED IN THE MANUFACTURE OF THE DEVICE.
P020011|S001|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2009|05/22/2009|||OK30|CHANGE OF THE ACTIVATOR USED IN THE SYNTHESIS OF DNA OLIGONUCLEOTIDES FROM 1-H TETRAZOLE TO 5-ETHYLTHIO 1-H TETRAZOLE (ETT) AND THE ADDITION OF SIGMA-ALDRICH (SAFC) AS A SECONDARY SUPPLIER OF THE NEW ACTIVATOR (ETT).
P810046|S231|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER NC CORONARY DILATATION CATHETER|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2009|05/26/2009|||OK30|CHANGE FROM A MANUALLY PERFORMED OPERATION TO AN AUTOMATED OPERATION.
P860019|S236|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX MONORAIL & OVER-THE-WIRE PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2009|05/08/2009|||OK30|REMOVAL OF A REDUNDANT VERIFICATION STEP.
P960004|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II/THINLINE II BRADY LEADS|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2008|06/05/2009|||APPR|APPROVAL FOR THE ADDITION OF A NEW SUPPLIER, OPTINOVA, AND CHANGES IN SPECIFICATIONS FOR FOREIGN MATTER, GELS, AND BUBBLES FOR THE POLYURETHANE TUBING LEAD BODY USED IN THE DEVICE.
P000025|S042|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|SONATATI100 IMPLANT|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/04/2009|06/12/2009|||APPR|APPROVAL FOR THE IMPLANT TEMPLATE, SINGLE USE FOR THE SONATATI100 IMPLANT (SONATATI100 TEMPLATE SU).
P950008|S007|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/04/2009|10/30/2009|||APPR|APPROVAL FOR MODIFICATIONS OF SPECIFICATION RANGES FOR VISCOSITY AND MOLECULAR WEIGHT.  THE CURRENT SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 900 ¿ 1,250 CS AND 32,850 ¿ 47,000 DALTONS, RESPECTIVELY.  THE PROPOSED REGULATORY ACCEPTANCE SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 980 ¿ 1,350 CS AND 31,000 ¿ 44,500 DALTONS, RESPECTIVELY.
P040014|S010|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2009|06/01/2009|||OK30|CHANGE TO REALIGN THE HYPO TUBE.
P040042|S015|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2009|06/01/2009|||OK30|CHANGE TO REALIGN THE HYPO TUBE.
P060019|S008|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2009|06/01/2009|||OK30|CHANGE TO REALIGN THE HYPO TUBE.
P060008|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2009|05/26/2009|||OK30|CHANGE IN THE SUPPLIER SAMPLING PLAN FOR THE HYPOTUBE COMPONENT.
P910001|S031|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 CORONARY LASER CATHETER|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2009|06/01/2009|||OK30|CHANGES TO THE IN-PROCESS ACCEPTANCE ACTIVITIES FOR THE LABELING AND BOXING PROCESS.
P960042|S013|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH (SLS)|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2009|06/01/2009|||OK30|CHANGES TO THE IN-PROCESS ACCEPTANCE ACTIVITIES FOR THE LABELING AND BOXING PROCESS.
P000040|S014|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/2009|04/23/2010|||APPR|APPROVAL FOR THE ¿NEXT GENERATION¿ HTA SYSTEM WITH A REDESIGNED OPERATIONAL UNIT (CONTROL UNIT, POWER CORD, PEDESTAL, IV POLE) AND A MODIFIED STERILE PROCEDURE SET.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GENESYS HTA SYSTEM AND IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
P880047|S013|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2009|06/24/2009|||OK30|MODIFICATION OF A PROCESSING AID IN THE MANUFACTURING OF THE DEVICE.
P980022|S054|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR GLUCOSE SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2009|05/22/2009|||OK30|CHANGES TO THE SENSOR BASE AND THE NEEDLE/HUB COMPONENTS.
P030034|S002|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL STIM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2009|07/10/2009|||APPR|APPROVAL FOR THE RELOCATION AND CHANGE OF THE CHARGE MANAGEMENT CONTROLLER AND THE REPLACEMENT OF THE CHARGER UNIT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERVICAL-STIM CERVICAL FUSION SYSTEM AND IS INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSION.
P850007|S028|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM & SPINAL-STIM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2009|07/10/2009|||APPR|APPROVAL FOR THE RELOCATION AND CHANGE OF THE CHARGE MANAGEMENT CONTROLLER AND THE REPLACEMENT OF THE CHARGER UNIT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM AND SPINAL-STIM.  THE PHYSIO-SLIM IS INDICATED FOR THETREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALLFLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECTS IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED LO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLYPROGRESSIVE SIGNS OF HEALING. THE SPINAL-SLIM IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASETHE PROBABILITY OF FUSION SUCCESS AND AS A NON-OPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE LAST SURGERY.
P910073|S078|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE TACHY LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2009|06/10/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE MOLDED TERMINAL LEAD CONNECTOR.
P000053|S024|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/08/2009|07/06/2009|||APPR|APPROVAL OF A NEW, SMALLER 3.5 CM CUFF SIZE TO BE USED AS A COMPONENT OF THE EXISTING AMS 800 URINARY CONTROL SYSTEM, AND FOR RELATED LABELING CHANGES.
P010012|S211|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/08/2009|07/07/2009|||APPR|APPROVAL TO CHANGE THE THERMOFORMED BATTERY STACK INSULATOR MATERIAL FROM POLYIMIDE TO PEEK.
P960040|S197|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/08/2009|07/07/2009|||APPR|APPROVAL TO CHANGE THE THERMOFORMED BATTERY STACK INSULATOR MATERIAL FROM POLYIMIDE TO PEEK.
P040048|S008|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2009|08/27/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN MARKTREDWITZ, GERMANY.
P930029|S022|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONDUCTR ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2009|06/10/2009|||OK30|CHANGE TO THE WIRE BENDING MANUFACTURING PROCESS.
P020014|S025|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2009|06/11/2009|||OK30|CHANGE TO THE MANUFACTURING OF THE MECHANISM THAT HOLDS THE INNER CATHETER SUBASSEMBLY RELEASE RIBBON IN PLACE.
P910023|S210|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT/CURRENT+ ICD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2009|06/10/2009|||OK30|CHANGE IN BAKE TIME OF THE FLEX CIRCUIT COMPONENT.
P030054|S125|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE/PROMOTE+ CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2009|06/10/2009|||OK30|CHANGE IN BAKE TIME OF THE FLEX CIRCUIT COMPONENT.
P960040|S198|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN 4-SITE MODELS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/11/2009|11/10/2010|||APPR|APPROVAL FOR: 1) THE ELEVATED PRESSURE LABELING MODIFICATIONS FOR TELIGEN ICD MODELS E103, E111, E102 AND E110; AND 2) THE NEW 4-SITE HEADER FOR TELIGEN ICD MODELS E103 AND E111.
P040020|S016|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2009|06/10/2009|||OK30|EXTENSION OF TWO (2) WORK-IN-PROCESS QUEUE TIMES FOR THE DEVICE.
P010012|S212|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS 4-SITE MODELS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/11/2009|11/10/2010|||APPR|APPROVAL FOR: 1) THE ELEVATED PRESSURE LABELING MODIFICATIONS FOR TELIGEN ICD MODELS E103, E111, E102 AND E110; AND 2) THE NEW 4-SITE HEADER FOR TELIGEN ICD MODELS E103 AND E111.
P930014|S032|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF TORIC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2009|06/10/2009|||OK30|CHANGE TO THE MECHANICAL FOCUSING MECHANISM ON THE LENS BENCHES USED IN THE MANUFACTURE OF THE DEVICE.
P930014|S033|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2009|06/10/2009|||OK30|CHANGE IN MANUFACTURING EQUIPMENT.
P040020|S017|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|30-Day Notice||N|05/11/2009|06/10/2009|||OK30|CHANGE IN MANUFACTURING EQUIPMENT.
P030049|S006|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2009|05/27/2009|||OK30|CHANGE OF CRITICAL RAW MATERIAL SUPPLIER.
P040024|S040|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE AND PERLANE INJECTABLE GELS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2009|06/10/2009|||OK30|CHANGE IN THE ANALYZING LABORATORY FOR IDENTITY TESTING OF A RAW MATERIAL.
P960058|S081|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2009|06/12/2009|||OK30|CHANGE TO THE HIRES90K INDUCTOR ATTACHMENT PROCESS.
P010050|S008|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|05/13/2009|06/02/2009|||APPR|APPROVAL FOR REVISIONS TO THE PRODUCT LABELING TO INCLUDE A ¿HOT ZONE CUTOFF¿ UNDER THE INTERPRETATION OF RESULTS SECTION.  THIS ¿HOT ZONE CUTOFF¿ ESTABLISHES A LEVEL AT WHICH HIGH HBSAG REACTIVE SAMPLES MAY BE REPORTED AS REACTIVE WITHOUT CONFIRMATORY TESTING.
P060019|S009|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY COOL PATH CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/14/2009|02/23/2011|||APPR|APPROVAL TO ADD BI-DIRECTIONAL STEERING TO THE THERAPY COOL PATH ABLATION CATHETER.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SAFIRE BLU IRRIGATED ABLATION CATHETER AND THERAPY COOL PATH ABLATION CATHETER.
P950022|S060|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA LEAD MODELS|NVY|CV|Real-Time Process||N|05/14/2009|07/10/2009|||APPR|APPROVAL FOR PASSIVE FIXATION DURATA LEADS WITH SJ4 FOUR-POLE PROXIMAL CONNECTORS; MODEL NUMBERS 7170Q AND 7171Q.
P010003|S014|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2009|06/26/2009|||APPR|APPROVAL FOR PRINTING THE PRODUCT NAME ON THE SYRINGE BODY.
P030035|S055|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ANTHEM/FRONTIER II CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2009|06/12/2009|||OK30|ALTERNATE SUPPLIER FOR THE LOW VOLTAGE HYBRID ASSEMBLY.
P880086|S175|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT/ZEPHYR/ VICTORY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2009|06/12/2009|||OK30|ALTERNATE SUPPLIER FOR THE LOW VOLTAGE HYBRID ASSEMBLY.
P050033|S007|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/2009|06/01/2009|||APPR|APPROVAL FOR A CHANGE IN THE DEVICE NAME FROM ELEVESS TO HYDRELLE.
P990027|S012|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION|LZS|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2009|06/26/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE LOCATED AT TECHNOLAS PERFECTVISION GMBH, MUNICH, GERMANY.
P020014|S026|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2009|07/16/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AVAILMED S.A. DE C.V., TIJUANA, MEXICO.
P030029|S007|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2009|08/19/2009|||APPR|APPROVAL FOR THE ADVIA CENTAUR XP SYSTEM SOFTWARE VERSION 6.0.
P030049|S007|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR XP SOFTWARE V6.0 HBSAG & HBSAG CONFIRMATORY|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2009|08/19/2009|||APPR|APPROVAL FOR THE ADVIA CENTAUR XP SYSTEM SOFTWARE VERSION 6.0.
P030010|S004|SIEMENS MEDICAL SOLUTION|51 VALLEY STREAM PKWY.||MALVERN|PA|19355||Full field digital,system,x-ray,mammographic|MAMMOMAT NOVATION DR|MUE|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/18/2009|06/04/2009|||APPR|APPROVAL FOR LABELING CHANGES.
P030040|S006|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBC IGM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2009|08/19/2009|||APPR|APPROVAL FOR THE ADVIA CENTAUR XP SYSTEM SOFTWARE VERSION 6.0.
P050018|S006|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2009|10/30/2009|||APPR|APPROVAL FOR MODIFICATION TO THE CURRENT BACTERIAL ENDOTOXIN (LAL) TESTING PLAN.
P040004|S006|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBCT|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2009|08/19/2009|||APPR|APPROVAL FOR THE ADVIA CENTAUR XP SYSTEM SOFTWARE VERSION 6.0.
P030056|S006|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV|MZO|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2009|08/19/2009|||APPR|APPROVAL FOR THE ADVIA CENTAUR XP SYSTEM SOFTWARE VERSION 6.0.
P840001|S139|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2009|07/10/2009|||OK30|CHANGE TO THE DURATION OF THE DRYING TIME FOR THE ADHESIVE USED IN THE BONDING APPLICATION OF NEUROSTIMULATION LEADS.
P970004|S074|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF NEUROSTIMULATION LEADS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2009|07/10/2009|||OK30|CHANGE TO THE DURATION OF THE DRYING TIME FOR THE ADHESIVE USED IN THE BONDING APPLICATION OF NEUROSTIMULATION LEADS.
P980016|S194|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO II/SECURA FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2009|06/17/2009|||OK30|ADDITION OF A NEW BACK FILL LASER WELD UNIT.
P010031|S155|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2009|06/17/2009|||OK30|ADDITION OF A NEW BACK FILL LASER WELD UNIT.
P070015|S018|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2009|06/16/2009|||OK30|CHANGE TO THE IN-PROCESS ACCEPTANCE ACTIVITIES IN THE REFERENCE STANDARD SPECIFICATION DOCUMENT.
P000021|S015|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/2009|05/27/2010|||APPR|APPROVAL FOR THE DIMENSION TPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION EXL WITH LM SYSTEM.
P980022|S055|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK REAL-TIME TRANSMITTER & CGMS IPRO DIGITAL RECORDER|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2009|06/16/2009|||OK30|CHANGE TO THE HOUSING OF THE DEVICE.
P050019|S001|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/19/2009|09/25/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040045|S005|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2009|06/19/2009|||OK30|CHANGE IN A QUALITY CONTROL TEST METHOD FOR THE FINISHED DEVICE.
P970051|S050|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2009|02/02/2010|||APPR|APPROVAL FOR THE MATERIAL USED IN THE GREY TRANSMITTING COIL FOR THE FREEDOM SOUND PROCESSOR FROM SABIC ABS CYCOLAC GPM5500 TO SABIC MEDICAL GRADE ABS CYCOLAC HMG94MD.
P050018|S007|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2009|06/19/2009|||APPR|APPROVAL FOR THE ADDITION OF FURTHER USER INSTRUCTIONS IN THE INSTRUCTIONS FOR USE (IFU) TO ENHANCE THE SAFE USE OF THE MONORAIL (EASY EXCHANGE) DELIVERY PLATFORM OF THE ANGIOSCULPT SCORING BALLOON CATHETER.
P970021|S027|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2009|06/19/2009|||OK30|USE OF A NEW SUB-TIER SUPPLIER DURING THE MANUFACTURING OF THE DEVICE.
P030054|S126|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2009|06/18/2009|||OK30|MODIFICATION OF THE PLACEMENT PROCESS OF THE TELEMETRY COIL SUBSTRATE ONTO THE NYLON SUPPORT ASSEMBLY.
P910023|S211|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2009|06/18/2009|||OK30|MODIFICATION OF THE PLACEMENT PROCESS OF THE TELEMETRY COIL SUBSTRATE ONTO THE NYLON SUPPORT ASSEMBLY.
P990066|S033|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2009|07/10/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE SENOGRAPHE DS AND SENOGRAPHE ESSENTIAL FFDM SYSTEMS THAT WILL REMOVE BOTH MAGNIFICATION STANDS AND CORRESPONDING MAGNIFICATION COMPRESSION PADDLES FOR BOTH SYSTEMS.  THE COMPONENTS THAT ARE PROPOSED FOR REMOVAL FROM THE CONFIGURATION WILL STILL BE AVAILABLE TO THE CUSTOMER AS OPTIONAL EQUIPMENT.
P060037|S010|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2009|06/19/2009|||APPR|APPROVAL FOR: 1) ADDING A VERIFICATION STEP TO USE A POKE-YOKE FIXTURE TO SORT PRODUCT DURING MANUFACTURING; AND 2) ADDING A STEP TO VERIFY THE SPIRALOCK THREAD FUNCTION.
P020014|S027|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/22/2009|06/19/2009|||APPR|APPROVAL FOR CHANGES TO THE PHYSICIAN LABELING REGARDING PERFORATION AND HYPERVOLEMIA.
P010012|S213|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL/VITALITY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2009|11/16/2009|||APPR|APPROVAL TO ADD A NEW SOFTWARE SYSTEM.
P030005|S058|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2009|11/16/2009|||APPR|APPROVAL TO ADD A NEW SOFTWARE SYSTEM.
P940031|S065|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR/DISCOVER/MERIDIAN/PDP|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2009|11/16/2009|||APPR|APPROVAL TO ADD A NEW SOFTWARE SYSTEM.
P960040|S199|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM/VITALITY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2009|11/16/2009|||APPR|APPROVAL TO ADD A NEW SOFTWARE SYSTEM.
P030026|S018|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2009|06/12/2009|||OK30|EXTENSION OF THE SHELF-LIFE OF THE POSITIVE SERUM USED IN THE MANUFACTURING OF VITROS ANTI-HBC CALIBRATOR TO 2 YEARS (36 MONTHS).
P990021|S002|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, PHOTODYNAMIC THERAPY|ANGIO DYNAMICS 630PDT LASER|MVF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/2009|10/13/2010|||APPR|APPROVAL FOR THE USE OF AN ALTERNATIVE SOURCE OF LASER DIODE AND MODIFICATION OF THE THERMAL MANAGEMENT OF THE DEVICE.
P050043|S002|MORRIS INNOVATIVE RESEARCH INC|907 W.SECOND ST||BLOOMINGTON|IN|47403||Device, hemostasis, vascular|7F FISH-SP DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/2009|07/24/2009|||APPR|APPROVAL FOR THE ADDITION OF THE 7F FISH-SP DEVICE TO THE FISH PRODUCT LINE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 7F FISH-SP DEVICE FOR CLOSURE AND IS INDICATED FOR PERCUTANEOUS ACCESS AND CLOSURE OF THE COMMON FEMORAL ARTERY WHILE REDUCING TIME TO HEMOSTASIS, AMBULATION AND TIME TO ELIGIBLE DISCHARGE IN PATIENTS REQUIRING ACCESS OF 7F FOR ENDOVASCULAR PROCEDURE WITH SHEATH REMOVAL.
P910077|S094|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/2009|07/21/2009|||APPR|APPROVAL OF A SOFTWARE MAINTENANCE RELEASE (SMR) FOR THE LATITUDE SYSTEM SERVER SOFTWARE, V5.0.6, MODEL 6488.
P040038|S019|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/26/2009|11/06/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050020|S015|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2009|06/24/2009|||OK30|CHANGE TO THE MOLD TEMPERATURE.
P020027|S010|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/2009|05/27/2010|||APPR|APPROVAL FOR THE DIMENSION FPSA FLEX REAGENT CARTRIDGE ON THE DIMENSION EXL WITH LM SYSTEM.
P030047|S018|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2009|06/18/2009|||OK30|ADDITION OF A PACKAGING INSPECTION STEP.
P020036|S015|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2009|06/18/2009|||OK30|ADDITION OF A PACKAGING INSPECTION STEP.
P040021|S009|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA/EPIC/EPIC SUPRA HEART VALVES|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2009|06/24/2009|||OK30|CHANGE IN THE SUPPLIER FOR THE POLYESTER SUTURE.
P060038|S004|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2009|08/28/2009|||APPR|APPROVAL FOR THE ADDITION OF A NEW BOVINE PERICARDIUM SUPPLIER USED IN THE MANUFACTURE OF THE DEVICE.
P040037|S019|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2009|06/10/2009|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR TRIMMING THE EXCESS EPTFE GRAFT MATERIAL.
P810025|S027|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC & AMVISC PLUS|LZP|OP|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2009|06/14/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE AND CHANGE IN TERMINAL STERILIZATION METHOD (I.E., E-BEAM TO VAPOR HYDROGEN PEROXIDE) OF THE PRODUCT.
P980037|S031|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/27/2009|07/09/2009|||APPR|APPROVAL FOR CHANGES TO THE ANGIOJET ULTRA THROMBECTOMY SET PACKAGING, AND FOR CHANGES TO THE WASTE BAG AND SPIKE LINE TUBING COMPONENTS OF THE ANGIOJET ULTRA THROMBECTOMY SET.
P970018|S015|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|05/27/2009|07/24/2009|||APPR|APPROVAL FOR THE CHANGES MADE TO THE PREPSTAIN SOFTWARE PROGRAM IN RESPONSE TO RECALL Z-1090-2009.
P000046|S015|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II & SHELLGEL SODIUM HYAURONATE|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/27/2009|03/27/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE FROM THE PREVIOUS FACILITY IN WEST CUMMINGS PARK, WOBURN, MASSACHUSETTS TO THE NEW FACILITY LOCATED IN BEDFORD, MASSACHUSETTS. IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL TO CHANGE THE TERMINAL STERILIZATION METHOD OF THE PRODUCT FROM E-BEAM CONTROLLED DEPTH STERILIZATION TO VAPORIZED HYDROGEN PEROXIDE (VHP) GAS STERILIZATION.
P960040|S200|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2009|06/26/2009|||OK30|CHANGES TO: 1) MOVE THE FABRICATION OF THE L-TAB FROM AN OUTSIDE VENDOR TO IN-HOUSE; 2) ETCH THE TAB INSTEAD OF STAMPING IT; 3) ADD AN ALUMINUM SHEET METAL CONTRACTOR; AND 4) REVISE TWO DIMENSIONS OF THE TAB.
P010012|S214|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2009|06/26/2009|||OK30|CHANGES TO: 1) MOVE THE FABRICATION OF THE L-TAB FROM AN OUTSIDE VENDOR TO IN-HOUSE; 2) ETCH THE TAB INSTEAD OF STAMPING IT; 3) ADD AN ALUMINUM SHEET METAL CONTRACTOR; AND 4) REVISE TWO DIMENSIONS OF THE TAB.
P060008|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2009|06/25/2009|||OK30|MODIFICATIONS TO THE MANUFACTURING PROCESS FOR THE DRUG COATING.
P960043|S065|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|SUTURE MEDIATED CLOSURE SYSTEMS & ASSOCIATED ACCESSORIES|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2009|07/09/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO FOR ETHYLENE OXIDE STERILIZATION.
P050007|S014|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|VASCULAR CLOSURE SYSTEMS|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2009|07/09/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO FOR ETHYLENE OXIDE STERILIZATION.
P010033|S014|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE|NCD|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2009|01/29/2010|||APPR|APPROVAL FOR THE USE OF THE DRY ROOM AT SCANTIBODIES LABORATORY, INC., SANTEE, CALIFORNIA, TO BE USED AS AN ALTERNATIVE METHOD TO VACUUM DRYING IN THE MANUFACTURING PROCESS OF ELISA PLATES.
P970008|S044|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2009|06/24/2009|||OK30|ADDITION OF AN ADHESIVE TO THE MANUFACTURING OF A CONTROL UNIT.
P010031|S156|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2009|10/27/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID TEST.
P980016|S195|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II DR/VR|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2009|10/27/2009|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID TEST.
P070015|S019|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2009|07/02/2009|||OK30|CHANGE TO A MATERIAL SPECIFICATION ACCEPTANCE LIMIT.
P960042|S014|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH (SLS) CATHETERS|MFA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2009|07/28/2009|||APPR|APPROVAL FOR A CHANGE OF MATERIAL USED TO MAKE THE PROXIMAL COUPLER OF THE CATHETER.  THE MATERIAL WILL BE CHANGED FROM DOW MAGNUM 9555 TO SABIC CYCOLAC MG47MD.
P910001|S032|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM|LPC|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2009|07/29/2009|||APPR|APPROVAL FOR A CHANGE IN THE MATERIAL OF THE PROXIMAL COUPLER COMPONENT OF THE ELCA CATHETERS.
P030002|S020|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|NAA|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/2009|08/05/2011|||APPR|APPROVAL TO MARKET CRYSTALENS® MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) WITH A BENZOTRIAZOLE ULTRA-VIOLET (UV) ABSORBER CHROMOPHORE (UVAM). TO BE DESIGNATED AS MODELS AT1UV, AT2UV, HD1UV, HD2UV, AO1UV AND AO2UV.
P070027|S009|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2009|11/18/2009|||APPR|APPROVAL TO ADD MEDTRONIC MEXICO EG, EMPALME AS AN ADDITIONAL SUPPLIER AND A CHANGE TO THE IN-PROCESS ACCEPTANCE ACTIVITIES.
P070007|S010|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2009|11/20/2009|||APPR|APPROVAL TO ADD MEDTRONIC MEXICO EG, EMPALME AS A SUPPLIER FOR THE CHEMICALLY ETCHED STENT SPRINGS.
P070014|S001|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS|NIP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/2009|07/30/2009|||APPR|APPROVAL TO MODIFY THE NAME AND PACKAGE LABEL FOR THE LIFESTENTVASCULAR STENT SYSTEMS. SPECIFICALLY, THE WORD "FLEXSTAR" WILL BE REMOVED FROM THE TRADE NAMEAND "& BILIARY" WILL BE ADDED TO THE DEVICE PACKAGE LABELS TO REFLECT THE CLEARED BILIARY INDICATION FOR THIS DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFESTENTVASCULAR STENT SYSTEM AND LIFESTENT XL VASCULAR STENT SYSTEM AND IS INDICATED FORIMPROVEMENT OF LUMINAL DIAMETER IN THE TREATMENT OF DE-NOVO OR RESTENOTIC LESION IN THE NATIVESFA AND PROXIMAL POPLITEAL ARTERIES.
P010012|S215|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2009|06/30/2009|||OK30|ADDING A VACUUM BAKE PROCESS TO THE MANUFACTURING REWORK PROCESS.
P060007|S003|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/03/2009|06/05/2009|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW QUALITY CONTROL TESTING PROCEDURE WITH A 100-MEMBER PANEL FOR THE ARCHITECT HBSAG REAGENT CONJUGATE.
P950022|S061|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|DURATA/RIATA ST OPTIM/RIATA ST FAMILY OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2009|07/02/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P070015|S020|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2009|06/23/2009|||OK30|CHANGES TO QUALITY ENGINEERING TESTING FOR THE DEVICE.
P920047|S040|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2009|01/26/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN HEREDIA, COSTA RICA.
P020025|S021|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CATHETERS|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2009|01/26/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN HEREDIA, COSTA RICA.
P040045|S006|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2009|08/07/2009|||OK30|CHANGE IN A QUALITY CONTROL TEST FOR THE FINISHED DEVICE.
P020018|S033|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT|MIH|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/04/2009|07/24/2009|||APPR|APPROVAL FOR LABELING CHANGES INCLUDING A CHANGE TO CONDITIONAL MR COMPATIBILITY.
P980040|S027|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1 PIECE IOL MODEL ZCB00|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|07/17/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS PARAMETERS FOR THE DEVICE.
P080010|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL SILICONE IOL/MODEL ZM900 & THE TECNIS MULTIFOCAL FOLDABLE ACRYLIC IOL MODEL ZMA00|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|07/17/2009|||OK30|CHANGE IN THE STERILIZATION PROCESS PARAMETERS FOR THE DEVICE.
P860057|S057|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/09/2009|11/03/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P790018|S052|MEDTRONIC CARDIAC SURGERY|8299 CENTRAL AVE., N.E.||SPRING LAKE PARK|MN|55432|3576|HEART-VALVE, MECHANICAL|MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|07/09/2009|||OK30|CHANGES TO THE BIOBURDEN TESTING AND CHANGE TO THE STERILIZATION TEST METHODS.
P880003|S097|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|FIRE STAR RX PTCA BALLOON DILATATION CATHETER|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|11/05/2009|||APPR|APPROVAL FOR THE ADDITION OF CORDIS DE MEXICO AS AN ALTERNATE MANUFACTURER OF THE BALLOON COMPONENT FOR THE DEVICE.
P970018|S016|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|07/02/2009|||OK30|CHANGES TO THE METHOD OF MANUFACTURING FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS TO REDUCE PRODUCTION COSTS AND IMPROVE CONTROL OF THE MANUFACTURING PROCESS.
P910061|S018|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|07/16/2009|||OK30|CHANGE FROM STERILE WATER TO PROCESSED WATER IN FINAL PRODUCT INSPECTION.
P040002|S024|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|01/06/2010|||APPR|APPROVAL FOR A CHANGE IN GRAFT PROCESSING PROCEDURES.
P040037|S020|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|07/08/2009|||OK30|ADDITION OF AN ALTERNATE MANUFACTURING LOCATION WITHIN THE FLAGSTAFF, ARIZONA FACILITY.
P900009|S031|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN BONE HEALING SYSTEM|LPQ|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2009|10/02/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN MEMPHIS, TENNESSEE.
P040024|S041|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|CHANGES IN SANITATION CRITERIA FOR WATER FOR INJECTION (WFI), REDUCTION OF WATER SAMPLING FOR PURIFIED WATER (PW) AND WFI, AND REDUCTION OF FREQUENCY OF PERIODIC REVIEW OF UTILITY SYSTEMS.
P830055|S111|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2009|09/16/2009|||APPR|APPROVAL FOR THE ADDITION OF THE SIGMA PS (LUGGED AND NON-LUGGED) FEMORAL COMPONENTS AS COMPATIBLE COMPONENTS WITH THE MBT TIBIAL TRAYS (CEMENTED, KEELED, POROUS), THE MBT TIBIAL TRAYS (CEMENTED), AND THE SIGMA RP PS TIBIAL INSERTS.
P980037|S032|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2009|08/07/2009|||APPR|APPROVAL FOR CHANGES TO THE HIGH PRESSURE SEAL COMPONENT OF THE ANGIOJET ULTRA THROMBECTOMY SETS.
P010033|S015|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON - TB GOLD IN-TUBE|NCD|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|01/25/2010|||APPR|APPROVAL TO ALLOW THE USE OF DRY PEPTIDES TO BE FORMULATED AT CELLESTIS AND SHIPPED TO THE CONTRACT MANUFACTURER FOR THE MANUFACTURE OF TB ANTIGEN BLOOD COLLECTION TUBES.
P060037|S011|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN COMPLETE KNEE SOLUTION/LEGACY KNEE - POSTERIOR STABILIZED (LPS)/LPS-FLEX MOBILE BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/06/2009|||OK30|CHANGES IN THE SHELL DIPPING PROCESS FOR THE DEVICE.
P030017|S093|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2009|06/08/2010|||APPR|Approval for a change in labeling that updates the Instructions for Use and the Patient Information Brochure to include the most recent clinical data up to 2 years.
P960040|S201|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|CHANGE TO THE TOLERANCE FOR A COMPONENT.
P010012|S216|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|CHANGE TO THE TOLERANCE FOR A COMPONENT.
P080006|S002|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2009|04/01/2011|||APPR|APPROVAL FOR THE ATTAIN ABILITY¿ PLUS MODEL 4296 LEAD.
P880086|S176|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P970013|S029|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P880006|S062|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|REGENCY PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P960013|S047|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL/TENDRIL ST/OPTISENSE LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P960030|S026|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFLEX OPTIM LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P950022|S062|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA/RIATA ST/DURATA LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P030035|S056|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II PACEMAKERS/AESCULA LEADS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P030054|S127|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/EPIC+ HF/EPIC II HF/EPIC II+HF/ATLAS HF/ATLAS+HF/ATLAS II HF/ATLAS II+HF CRT-DS/QUICKSITE/QUICKFLEX LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P910023|S212|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2009|07/10/2009|||OK30|THREE STERILIZATION CHANGES.
P040003|S006|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2100 SYSTEM|NRZ|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/05/2009|12/22/2009|||APPR|APPROVAL FOR ADDITION OF ENHANCED SONICATION, A DETACHABLE CRADLE, AND SEVERAL OTHER MODIFICATIONS TO THE EXABLATE 2000 SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXABLATE 2100 AND IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE- OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE AND WHOSE UTERINE SIZE IS LESS THAN 24 WEEKS.  PATIENTS SHOULD HAVE COMPLETED CHILD BEARING.
P970051|S051|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/16/2009|||OK30|AMENDMENT TO THE ENVIRONMENTAL MONITORING PROGRAM AND THE MICROBIAL AND ENVIRONMENTAL CONTROLS PROCEDURE.
P910077|S095|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/06/2009|||OK30|ADDITION OF A NEW SUPPLIER FOR THE DSUB COMPONENT AND SPECIFICATION CHANGES TO THE COMPONENT.
P050006|S012|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/27/2009|||APPR|APPROVAL FOR A DUPLICATE MANUFACTURING SITE FOR THE FINAL ASSEMBLY STEP OF THE DEVICE.
P980035|S137|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/10/2009|||OK30|ADDITION OF A NEW STERILIZER AND AERATOR.
P010031|S157|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC FAMILY OF ICDS/CONCERTO/MAXIMO II CRT-D/CONSULTA CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/10/2009|||OK30|ADDITION OF A NEW STERILIZER AND AERATOR.
P010015|S069|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P/INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/10/2009|||OK30|ADDITION OF A NEW STERILIZER AND AERATOR.
P970018|S017|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/2009|11/16/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE INTENDED USE OF THE PREPSTAIN SYSTEM TO ALLOW FOR THE REMOVAL OF A 0.5 ML ALIQUOT OF THE PATIENT SPECIMEN COLLECTED IN THE SUREPATHPRESERVATIVE FLUID COLLECTION VIAL, PRIOR TO PROCESSING WITH THE PREPSTAIN SYSTEM, FOR TESTINGWITH THE BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIA GONORRHOEAE(GC) QX (GCQ) AMPLIFIED DNA ASSAYS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME PREPSTAIN SYSTEM (FORMERLY THE AUTOCYTE PREP SYSTEM) AND IS INDICATED FOR ALIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDESTHAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGICAL PAP SMEARS.  SUREPALH SLIDES (FORMERLY THE AUTOCYTE PREP SLIDES) ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OFCERVICAL CANCER, PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES. SUREPATHPRESERVATIVE FLUID IS AN APPROPRIATE COLLECTION AND TRANSPORTATION MEDIUM FOR GYNECOLOGICSPECIMENS TESTED WITH BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIAGONORRHOEAE (GC) QX (GCQ) AMPLIFIED DNA ASSAYS.
P990001|S054|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/DDDR/CLARITY SSIR/DIAMOND III/RUBY III/TOPAZ III/JADE III/VITA 2 DDDR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/10/2009|||OK30|ADDITION OF A NEW STERILIZER AND AERATOR.
P980016|S196|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/MAXIMO II CRT-D/SECURA FAMILY ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/10/2009|||OK30|ADDITION OF A NEW STERILIZER AND AERATOR.
P970012|S055|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR IPG/KAPPA 400 SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2009|07/10/2009|||OK30|ADDITION OF A NEW STERILIZER AND AERATOR.
P950029|S045|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY DR/SR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2009|09/04/2009|||OK30|CHANGE TO A VISUAL INSPECTION.
P980049|S049|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ISOLINE 2CR PACINGS LEADS|MRM|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/16/2009|07/15/2009|||APPR|APPROVAL FOR THE ADDITION OF TWO WARNINGS REGARDING THE USE OF STRAIGHT STYLETS DURING IMPLANT PROCEDURES WITH THE ISOLINE 2CR DEFIBRILLATION LEADS.
P030019|S014|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2009|12/30/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE IN BEDFORD, MASSACHUSETTS.
P050020|S017|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|01/19/2010|||APPR|APPROVAL FOR A PROCESS VALIDATION ON THE SHARP MANUFACTURED AT OBERG INDUSTRIES (IN FREEPORT, PENNSYLVANIA) AS WELL AS TO WIDEN DIMENSIONAL TOLERANCES ON THE SHARP IN BOTH LENGTH AND ANGLE BEND.  CURRENTLY ALL SHARPS PRODUCED AT OBERG MUST UNDERGO 100% INSPECTION AT FACET (IN MARIETTA, GEORGA) PRIOR TO ITS ASSEMBLING INTO THE SENSOR INSERTER OF THE SENSOR DELIVERY UNIT (SDU) OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM.  THE PROCESS VALIDATION PROVIDED IN THIS SUPPLEMENT WILL REPLACE THE 100% INSPECTION REQUIREMENT AT FACET.
P860003|S054|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2009|09/15/2009|||APPR|APPROVAL FOR THE TRANSFER OF FINISHED PRODUCT TESTING TO STERIPRO LABS FROM THERAKOS, INC.
P910077|S096|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2009|10/30/2009|||APPR|APPROVAL FOR CHANGES TO THE ASSEMBLY LINE.
P890003|S172|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD LEAD|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P820003|S092|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P900061|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD END CAP KIT / LEAD ADAPTOR SLEEVE KIT / UPSIZING SLEEVE KIT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P930022|S010|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P970012|S056|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P980016|S197|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P980035|S138|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P850051|S071|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P950029|S046|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY DR/SR|NVZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2009|07/15/2009|||APPR|APPROVAL FOR THE ADDITION OF AN INSPECTION STEP TO CHECK FOR EXCESSIVE SILICONE ADHESIVE IN THE SET SCREW CAVITY.
P990001|S055|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P020004|S044|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2009|07/17/2009|||OK30|CHANGE TO EXPAND THE MANUFACTURING CAPABILITIES TO A NEW FACILITY, GORE DEER VALLEY IN PHOENIX, ARIZONA.
P980050|S042|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P010015|S070|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P010031|S158|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2009|07/28/2009|||APPR|APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
P870024|S047|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens,contact(rigid gas permeable)-extended wear|RIGID GAS PERMEABLE CONTACT LENS|MWL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/17/2009|12/11/2009|||APPR|APPROVAL FOR PACKAGING THE CONTACT LENSES IN A DIFFERENT MULTIPURPOSE SOLUTION WHEN SHIPPED WET.
P070014|S002|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|07/17/2009|||OK30|MODIFICATION OF THE QUALITY CONTROL INSPECTION TESTING ON POST-STERILE DEVICES.
P930014|S034|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|10/29/2009|||APPR|APPROVAL FOR A CHANGE IN THE LENS HOLDER IN THE MANUFACTURING PROCESS OF THE DEVICE.
P040020|S018|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|10/29/2009|||APPR|APPROVAL FOR A CHANGE IN THE LENS HOLDER IN THE MANUFACTURING PROCESS OF THE DEVICE.
P950032|S052|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/2009|11/03/2009|||APPR|APPROVAL FOR REVISIONS TO THE APLIGRAF PACKAGE INSERT (PART NUMBER: 300111-6).
P030054|S128|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|07/17/2009|||OK30|ALTERNATE BUFFING PROCESS.
P910023|S213|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|07/17/2009|||OK30|ALTERNATE BUFFING PROCESS.
P030035|S057|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|07/17/2009|||OK30|ALTERNATE BUFFING PROCESS.
P880006|S063|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|07/17/2009|||OK30|ALTERNATE BUFFING PROCESS.
P880086|S177|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|07/17/2009|||OK30|ALTERNATE BUFFING PROCESS.
P970013|S030|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2009|07/17/2009|||OK30|ALTERNATE BUFFING PROCESS.
P080023|S001|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT CORE ASSAY|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2009|12/10/2009|||APPR|APPROVAL FOR MIGRATION OF THE ARCHITECT® CORE¿ ASSAY TO A NEWARCHITECT® I SYSTEM FAMILY MEMBER, THE ARCHITECT® I 1000SR.THE ARCHITECT CORE REAGENT KIT DEVICE IS INDICATED FOR:THE ARCHITECT CORE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY(CMIA) FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B COREANTIGEN (ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED AS AN AID IN THE DIAGNOSIS OF ACUTE, CHRONIC, OR RESOLVED HEPATITIS B VIRUS (HBV) INFECTION IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION.
P880090|S026|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2009|07/31/2009|||OK30|CHANGE IN THE BLOW-OFF PROCESS IN THE AIR DRYING OF THE POLYMETHYLMETHACRYLATE LENSES.
P840039|S058|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2009|07/31/2009|||OK30|CHANGE IN THE BLOW-OFF PROCESS IN THE AIR DRYING OF THE POLYMETHYLMETHACRYLATE LENSES.
P040027|S015|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIABAHN TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2009|07/10/2009|||OK30|ELIMINATION OF SEVERAL ENVIRONMENTAL MONITORING TESTS.
P040037|S021|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice||N|06/19/2009|07/10/2009|||OK30|ELIMINATION OF SEVERAL ENVIRONMENTAL MONITORING TESTS.
P870056|S033|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHETIC PULMONIC VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2009|07/09/2009|||OK30|ADDITIONAL SUPPLIER OF YARN MATERIAL.
N16837|S007|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2009|07/21/2009|||OK30|MODIFICATION TO THE QUALITY CONTROL SAMPLING PLAN FOR A PORTION OF FINISHED DEVICE TESTING.
P040045|S007|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES CLEAR/VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2009|02/19/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE STABILITY PROTOCOL UTILIZED TO ESTABLISH SHELF-LIFE.
N18033|S042|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER|LPM|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2009|02/19/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE STABILITY PROTOCOL UTILIZED TO ESTABLISH SHELF-LIFE.
P980022|S056|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR GLUCOSE SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2009|07/16/2009|||OK30|CHANGES TO THE TUBE PREPARATION AND SENSOR FABRICATION PROCESSES.
P050044|S009|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2009|07/23/2009|||OK30|CHANGE IN THE ENDOTOXIN ASSAY.
P030054|S129|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2009|07/23/2009|||OK30|CHANGE IN WAFER TEST AND HYBRID TEST.
P910023|S214|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2009|07/23/2009|||OK30|CHANGE IN WAFER TEST AND HYBRID TEST.
P040034|S011|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2009|10/23/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COVIDIEN LP, NORTH HAVEN, CONNECTICUT.
P050047|S008|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/23/2009|08/26/2009|||APPR|APPROVAL FOR AN ADDITION OF 0.4 ML FILLED SYRINGE CONFIGURATION.
P040043|S029|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2009|11/12/2009|||APPR|APPROVAL FOR A PROCESS CHANGE IN THE MANUFACTURE OF THE TOMO DELIVERY CATHETER OF THE DEVICE.
P020004|S045|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCULDER AAA ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2009|02/03/2010|||APPR|APPROVAL TO ADD AN ALTERNATE SUPPLIER FOR A COMPONENT USED FOR THE GORE EXCLUDER® AAA ENDOPROSTHESIS DELIVERY CATHETER.
P080014|S001|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2009|07/22/2009|||OK30|ADDITIONAL SUPPLIER FOR CERVISTA HPV HR OLIGO MIXES 1, 2, AND 3.
P070015|S021|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2009|07/17/2009|||OK30|MODIFICATION TO THE BIOBURDEN TESTING FREQUENCY.
P010012|S217|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2009|11/10/2009|||APPR|APPROVAL FOR CHANGES TO THE ELECTRICAL TEST SOFTWARE.
P960040|S202|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS/TELIGEN|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2009|11/10/2009|||APPR|APPROVAL FOR CHANGES TO THE ELECTRICAL TEST SOFTWARE.
P860057|S058|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2009|07/21/2009|||OK30|NEW FLOW AND LEAFLET COAPTATION TESTING SYSTEM.
P040044|S015|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/2009|07/13/2009|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE.  SPECIFICALLY, TO INCLUDE A 10 SECOND AND 60 SECOND WAIT TIME FOR DIAGNOSTIC AND INTERVENTIONAL PROCEDURES RESPECTIVELY, PRIOR TO DEFLATING AND REMOVING THE BALLOON CATHETER.
P950009|S010|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT GS IMAGING SYSTEM|MNM|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2009|03/15/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIPATH IMAGING, INC. IN MELBANE, NORTH CAROLINA.
P980016|S198|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/SECURA/VIRTUOSO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/30/2009|||OK30|CHANGE TO THE SUPPLIERS MANUFACTURING PROCESS.
P010031|S159|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC II/III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/30/2009|||OK30|CHANGE TO THE SUPPLIERS MANUFACTURING PROCESS.
P980035|S139|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/30/2009|||OK30|CHANGE TO THE SUPPLIERS MANUFACTURING PROCESS.
P010013|S024|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/2009|07/31/2009|||APPR|APPROVAL FOR CHANGES INTENDED TO IMPROVE THE INSTRUCTIONS FOR USE BY ADDING A CONTRAINDICATION FOR USE IN PATIENTS WITH A METAL OBJECT IN THE UTERUS OR UTERINE CAVITY.
P020004|S046|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|06/30/2009|07/29/2009|||OK30|CHANGE IN THE STENT WINDING MANUFACTURING PROCESS.
P040043|S030|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/29/2009|||OK30|CHANGE IN THE STENT WINDING MANUFACTURING PROCESS.
P980040|S028|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1 PIECE IOL MODEL ZCB00|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/23/2009|||OK30|CHANGE IN THE ETHYLENE OXIDE RESIDUALS TESTING.
P080010|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL IOLS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/23/2009|||OK30|CHANGE IN THE ETHYLENE OXIDE RESIDUALS TESTING.
P990050|S007|SPECTRA SCIENCE|11568 SORRENTO VALLEY RD,SUITE|11|SAN DIEGO|CA|92121||ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)|WAVSTAT OPTICAL BIOPSY SYSTEM|MOA|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/2009|08/27/2009|||APPR|APPROVAL FOR MINOR DESIGN CHANGES DUE TO THE HARDWARE PARTS¿ OBSOLESCENCE, MINOR LABELING CHANGES TO REFLECT THE CHANGES IN THE HARDWARE, AND A SOFTWARE CHANGE TO UPDATE THE OPERATING SYSTEM.
P050007|S015|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|11/13/2009|||APPR|APPROVAL TO CHANGE TWO MANUALLY PERFORMED OPERATIONS TO SEMI-AUTOMATED OPERATIONS AND THE REMOVAL OF AN IN-PROCESS INSPECTION.
P020047|S015|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/28/2009|||OK30|CHANGES IN STENT RETENTION TESTING FOR THE DEVICE.
P040020|S019|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF MULTIFOCAL POSTERRIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/23/2009|||OK30|USE OF AN ALTERNATE ETHYLENE OXIDE GAS BLEND STERILANT USED DURING TERMINAL STERILIZATION.
P930014|S035|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF MONFOCAL/ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES/ACRYSERT DELIVERY SYSTEM|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/23/2009|||OK30|USE OF AN ALTERNATE ETHYLENE OXIDE GAS BLEND STERILANT USED DURING TERMINAL STERILIZATION.
P840060|S031|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/23/2009|||OK30|USE OF AN ALTERNATE ETHYLENE OXIDE GAS BLEND STERILANT USED DURING TERMINAL STERILIZATION.
P880087|S013|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/23/2009|||OK30|USE OF AN ALTERNATE ETHYLENE OXIDE GAS BLEND STERILANT USED DURING TERMINAL STERILIZATION.
P810032|S054|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2009|07/23/2009|||OK30|USE OF AN ALTERNATE ETHYLENE OXIDE GAS BLEND STERILANT USED DURING TERMINAL STERILIZATION.
P000037|S016|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2009|10/16/2009|||APPR|APPROVAL TO MOVE A MANUFACTURING OPERATION FROM AN OUTSIDE VENDOR TO IN-HOUSE.
P010032|S031|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS, GENESISXP/DUAL XP, GENESISRC, GENESIS DUAL 4-CHANNEL, EON, EONC, AND EONMINI NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2009|07/31/2009|||APPR|APPROVAL FOR THE RAPID PROGRAMMER SOFTWARE VERSION 3.3.0.
P050028|S004|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST|MKT|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2009|09/09/2010|||APPR|APPROVAL FOR A DEVICE DESIGN MODIFICATION THAT INCLUDES REAGENTS, DISPOSABLES,AND INSTRUMENTATION, TO AUTOMATE THE MANUAL SAMPLE PREPARATION PROCESS CURRENTLY USED BY THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM. THE DEVICE, AS MODIFIED,WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLIPREP/ COBAS TAQMAN HBV TEST, V2.0AND IS INDICATED FOR:THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 IS AN IN VITRO NUCLEIC ACIDAMPLIFICATION LEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM ORPLASMA (EDTA), USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSINGAND THE COBAS TAQMAN ANALYZER OR COBAS TAQMAN 48 ANALYZER FOR AUTOMATEDAMPLIFICATION AND DETECTION.THIS TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTIONUNDERGOING ANTIVIRAL THERAPY. THE TEST CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM THE COBASAMPLIPREP/ COBAS TAQMAN1 HBV TEST, V2.0 MUST BE INTERPRETED WITHIN THE CONTEXT OF ALLRELEVANT CLINICAL AND LABORATORY FINDINGS.ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH ADEFOVIRDIPIVOXIL. ASSAY PERFORMANCE FOR DETERMINING THE SLATE OF HBV INFECTION HAS NOT BEEN ESTABLISHED.THE COBAS AMPLIPREP/ COBAS TAQMAN HBV TEST, V2.0 IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HBV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TOCONFIRM THE PRESENCE OF HBV INFECTION.
P010015|S071|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC/INSYNC III CRT-PS|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2009|12/07/2009|||APPR|APPROVAL FOR REPLACING OBSOLETE EQUIPMENT WITH NEW EQUIPMENT.
P040027|S016|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2009|07/30/2009|||OK30|RELOCATION OF THE MANUFACTURING OF THE DEVICE FROM ONE BUILDING TO ANOTHER WITHIN THE SAME CAMPUS.
P860004|S108|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2009|09/04/2009|||APPR|APPROVAL FOR: 1) UPDATED MANUALS WITH THE GENERAL TERM "PLASTIC" TO DESCRIBE THE NEW HUB/CAP MATERIAL AND ADDED OTHER MINOR CLARIFICATIONS;2) ADDED COMPARTMENT TO FORM AN INNER TRAY TO CONTAIN ACCESSORIES - ELIMINATES BAGGING AND REDUCES MANUFACTURING COST;3) INNER TRAY IS PLACED IN AN OUTER TRAY AND SEALED WITH A POLYETHYLENE LID;4) INNER TRAY, INNER LID AND OUTER TRAY MATERIAL CHANGED TO POLYETHYLENE TEREPHTHALATE (PET)FOR IMPROVED RECYCLING; AND5) MODIFIED BOX TO ACCOMMODATE NEW TRAY DESIGN AND ADDITIONAL (EUROPEAN) LANGUAGES INMANUALS.
P000010|S014|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2009|07/30/2009|||OK30|ELIMINATION OF FUNCTIONAL RELEASE TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.
P000012|S021|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2009|07/30/2009|||OK30|ELIMINATION OF FUNCTIONAL RELEASE TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.
P060030|S004|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2009|07/30/2009|||OK30|ELIMINATION OF FUNCTIONAL RELEASE TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.
P050028|S005|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2009|07/30/2009|||OK30|ELIMINATION OF FUNCTIONAL RELEASE TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.
P040012|S030|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK/ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2009|08/05/2009|||OK30|EXPANSION OF THE ACCULINK MANUFACTURING PROCESSES WITHIN THE EXISTING MANUFACTURING FACILITY IN TEMECULA, CALIFORNIA.
P990004|S016|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFLO HEMOSTATIC MATRIX KIT|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2009|10/02/2009|||APPR|APPROVAL FOR PERMISSION TO MARKET THE SURGIFLO HEMOSTATIC MATRIX KIT CONSISTING OF THE SURGIFLO HEMOSTATIC MATRIX AND EVITHROM LYOPHILIZED HUMAN THROMBIN.
P040013|S014|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENHANCED MATRIX|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2009|08/12/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN SHIRLEY, NEW YORK, FOR THE MANUFACTURE OF THE RECOMBINANT HUMAN PLATELET-DERIVED GROWTH FACTOR-BB SYRINGE AND A QUALITY TESTING FACILITY AT ANOTHER LOCATION IN SHIRLEY, NEW YORK, FOR THE TESTING FOR THE RAW MATERIAL, FINISHED PRODUCT RELEASE, AND STABILITY WITH THE EXCEPTION OF THE BIOASSAY FOR THE DRUG COMPONENT OF THE DEVICE.
P860008|S019|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS|LPA|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/06/2009|08/18/2009|||APPR|APPROVAL FOR MODIFICATION OFF THE LABELING TO ENHANCE THE SAFETY IN THE USE OF THE PRODUCTS.
P050007|S016|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2009|07/27/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P870056|S034|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2009|07/23/2009|||OK30|ADDITIONAL SUPPLIER FOR POLYESTER SEWING THREAD.
P040024|S042|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE AND PERLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2009|08/06/2009|||OK30|ALTERNATE ENDOTOXIN TEST METHOD.
P060038|S005|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2009|08/07/2009|||OK30|CHANGE IN THE MINIMUM EXPOSURE TIME FOR THE STERILIZATION PROCESS OF THE DEVICE.
P000053|S025|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2009|08/05/2009|||OK30|UPGRADING OF THE HEATING SYSTEM USED IN THE MANUFACTURE OF THE DEVICE.
P950037|S072|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA / ENTOVIS & VARIOUS OTHER PULSE GENERATORS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2009|05/07/2010|||APPR|APPROVAL FOR THE EVIA/ENTOVIS PULSE GENERATORS.
P000009|S035|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|EVIA/ENTOVIS PULSE GENERATORS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2009|05/07/2010|||APPR|APPROVAL FOR THE EVIA/ENTOVIS PULSE GENERATORS.
P050023|S024|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KRONOS LV-T AND LUMAX 300/340 & 500/540 HF/HF-T|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2009|05/07/2010|||APPR|APPROVAL FOR THE EVIA/ENTOVIS PULSE GENERATORS.
P070008|S011|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|EVIA/ENTOVIS PULSE GENERATORS|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2009|05/07/2010|||APPR|APPROVAL FOR THE EVIA/ENTOVIS PULSE GENERATORS.
P980040|S029|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/09/2009|01/22/2010|||APPR|APPROVAL FOR THE TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL), MODEL ZMB00.
P860004|S109|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP)|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/2009|08/06/2009|||APPR|APPROVAL FOR AN ERRATA INSERT COMMUNICATING THE INCOMPATIBILITY ISSUE OF THE SUTURELESS CONNECTORS TO THE MODEL 8472 ISOMED CONSTANT-FLOW PUMP.
P990034|S013|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP)|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/2009|08/06/2009|||APPR|APPROVAL FOR AN ERRATA INSERT COMMUNICATING THE INCOMPATIBILITY ISSUE OF THE SUTURELESS CONNECTORS TO THE MODEL 8472 ISOMED CONSTANT-FLOW PUMP.
P040045|S008|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2009|08/06/2009|||OK30|CHANGE IN A QUALITY CONTROL TEST METHOD FOR THE FINISHED DEVICE.
P970031|S025|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2009|07/27/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P990064|S027|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2009|07/27/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P980043|S020|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2009|07/27/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P790007|S022|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2009|07/27/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P970008|S045|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/14/2009|08/27/2009|||APPR|APPROVAL TO REPLACE AN OBSOLETE CONNECTOR USED IN THE TARGIS AND CTC ADVANCE TREATMENT CATHETERS AND TO IMPROVE THE CONNECTOR JUNCTION IN THE CTC ADVANCE CATHETERS
P950018|S011|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2009|08/14/2013|||APPR|APPROVAL FOR A MODIFIED STABILITY PROTOCOL, A CHANGE IN THE PACKAGING TO AN ALTERNATE ALUMINUM SEAL WITH A FLIP-OFF CAP, AND THE ADDITION OF A PRE-PROCESSING MODIFICATION TO SILICONIZE THE STOPPERS USED IN THE FILLING, STOPPING, AND SEALING OF  PERFLUORON..
P000053|S026|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2009|08/13/2009|||OK30|REPLACEMENT OF DIPPING EQUIPMENT USED IN THE MANUFACTURE OF THE DEVICES.
P010020|S014|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2009|08/13/2009|||OK30|REPLACEMENT OF DIPPING EQUIPMENT USED IN THE MANUFACTURE OF THE DEVICES.
P980022|S057|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MMT-7002 & MMT-7003 GLUCOSE SENSORS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2009|08/13/2009|||OK30|ADDITION OF AN ADDITIONAL ELECTROPLATING LINE FOR THE SENSORS.
P010032|S032|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON IMPLANTABLE PULSE GENERATOR (IPG) NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/15/2009|04/08/2010|||APPR|APPROVAL FOR THE INCORPORATION OF A COLOR ADDITIVE TO CHANGE THE COLOR OF THE POCKET SIZER TO YELLOW, SO THAT IT WOULD BE MORE EASILY VISIBLE TO THE PHYSICIAN.
P050014|S002|FUJIFILM MEDICAL SYSTEM U.S.A., INC.|419 WEST AVE.||STAMFORD|CT|06902||Full field digital,system,x-ray,mammographic|FULL FIELD DIGITAL MAMMOGRAPHY|MUE|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/15/2009|08/11/2009|||APPR|APPROVAL FOR: 1) CHANGES IN THE CNR WEEKLY CHECK - QC TECHNOLOGIST; 2) CHANGE TO THE MONITOR QC - MEDICAL PHYSICIST TEST LUMINANCE RESPONSE TEST; 3) NEW TERMINOLOGY REGARDING USE OF THE TERM -ACQUISITION WORKSTATION; AND 4) TRADE NAME CHANGE TO ASPIRE.
P040044|S016|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/15/2009|08/04/2009|||APPR|APPROVAL FOR CHANGING THE LID COMPONENT OF THE MYNX PACKAGING, FROM TYVEK MATERIAL TO A PETG MATERIAL LID.
P040024|S043|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE AND PERLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2009|08/14/2009|||OK30|ELIMINATION OF THE STERILIZATION OF GARMENTS BEFORE USE.
P030054|S130|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Drug eluting permanent left ventricular (lv) pacemaker electrode|QUICKFLEX U MODEL 1258T LEAD|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/2009|05/10/2010|||APPR|APPROVAL FOR THE QUICKFLEX µ MODEL 1258TLEFT VENTRICULAR LEAD.
P860004|S110|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II INFUSION SYSTEM||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2009|08/20/2009|||OK30|AUTOMATION OF THE STEP WHERE DATA IS TRANSFERRED FROM THE CALIBRATION TESTING EQUIPMENT TO FACTORYWORKS, THE MANUFACTURING SOFTWARE THAT CONTROLS THE MANUFACTURING OF THE DEVICE.
P070015|S022|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2009|12/07/2009|||APPR|APPROVAL TO MODIFY AN IN-PROCESS SPECIFICATION.
P040044|S017|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2009|08/07/2009|||OK30|REDUCTION IN THE FREQUENCY OF LAL TEST SAMPLING FOR LOT RELEASE FOR THE DEVICE.
P040025|S009|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP SYSTEM|MXM|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2009|09/18/2009|||APPR|APPROVAL FOR THE COOL-CAP 1.1.1 SOFTWARE.
P020001|S006|NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|NEOVENTA'S STAN S31 FETAL HEART MONITOR|HEO|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/11/2009|11/16/2009|||APPR|APPROVAL FOR CHANGES TO THE CLINICAL GUIDELINES.  THE DEVICE ASMODIFIED WILL BE MARKETED UNDER THE TRADE NAME STAN S31 FETAL HEART MONITOR AND IS INDICATED FOR USE AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICAL INTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.THIS DEVICE IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 COMPLETED WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMNIOTIC MEMBRANES.
P060038|S006|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|08/14/2009|||OK30|CHANGE TO THE BASE SEAM STITCHING PATTERN.
P040033|S012|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING SYSTEM, REFLECTION CERAMIC ACETABULAR HIP SYSTEM|NXT|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|10/07/2009|||APPR|APPROVAL FOR THE USE OF NEW MANUFACTURING EQUIPMENT USED TO PRECLEAN DEVICES.
P030022|S012|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|10/07/2009|||APPR|APPROVAL FOR THE USE OF NEW MANUFACTURING EQUIPMENT USED TO PRECLEAN DEVICES.
P030010|S005|SIEMENS MEDICAL SOLUTION|51 VALLEY STREAM PKWY.||MALVERN|PA|19355||Full field digital,system,x-ray,mammographic|SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2009|10/06/2010|||APPR|APPROVAL FOR SIEMENS OWN IMAGE PROCESSING ALGORITHMS ON THE MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
P040033|S013|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|12/31/2009|||APPR|APPROVAL FOR A CHANGE TO NEW TESTING EQUIPMENT USED FOR MEASURING SURFACE FINISH, TAPE ANGLE, AND DIAMETER FOR THE R3 METAL LINERS.
P980016|S199|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II DR/VR, SECURA DR.VR, MAXIMO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|08/21/2009|||OK30|SEVERAL CHANGES TO D363 IC TEST.
P020004|S047|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|08/21/2009|||OK30|EXPANSION OF THE MANUFACTURING ENVIRONMENT FOR A COMPONENT OF THE FINAL DEVICE.
P050007|S017|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|08/13/2009|||OK30|ADDITION OF AN ALTERNATE ASSEMBLY STEP TO THE MANUFACTURING PROCESS FOR THE OBTURATOR RELEASE ROD ASSEMBLY.
P010031|S160|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|08/21/2009|||OK30|SEVERAL CHANGES TO D363 IC TEST.
P970051|S052|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2009|12/10/2009|||APPR|APPROVAL FOR A NUMBER OF MANUFACTURING CHANGES TO INCLUDE: 1) COSMETIC CHANGES TO IMPROVE THE ADHESION OF THE PAINT TO THE BATTERY CAN; 2) HOUSING CHANGES TO IMPROVE THE DURABILITY OF THE BATTERY AND TO INCREASE THE STRENGTH OF THE CAN; AND 3) CHANGES IN THE WELDING PROCESS TO IMPROVE ULTRASONIC WELD STRENGTH AND TO REDUCE WELD FAILURES.
P050006|S013|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2009|08/07/2009|||OK30|RELOCATION OF MANUFACTURING FROM ONE FACILITY TO ANOTHER WITHIN THE SAME REGISTERED ESTABLISHMENT.
P050020|S018|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice||N|07/23/2009|08/21/2009|||OK30|CHANGES TO THE PARAMETERS OF THE TRANSMITTER BOTTOM HOUSING MOLD.
P020001|S007|NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|STAN S31 SYSTEM|HEO|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/23/2009|02/01/2010|||APPR|APPROVAL FOR VARIOUS HARDWARE, SOFTWARE, AND LABELING UPGRADES INCLUDINGINTEGRATION OF MATERNAL NON-INVASIVE BLOOD PRESSURE AND OXYGEN SATURATION MONITORING ANDALARMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STAN S31 AND ISINDICATED FOR:MONITORING OF FETUS AND MOTHER THROUGHOUT LABOR AND DELIVERY. THE FOLLOWING PARAMETERSCAN BE MONITORED WITH STAN S31: 1) FETAL HEART RATE; 2) FETAL ECG WAVEFORM; 3) UTERINE ACTIVITY; 4) MATERNAL NON-INVASIVE BLOOD PRESSURE; 5) MATERNAL SPO2; AND 6) MATERNAL HEART RATE.THE STAN S31 FETAL HEART MONITOR FETAL ECG ANALYSIS FEATURE (ST ANALYSIS) ISINDICATED AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICALINTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.ST ANALYSIS IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMNIOTIC MEMBRANES.
P060033|S037|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2009|08/14/2009|||OK30|ADDITIONAL AUTOMATION OF THE BALLOON SUB-ASSEMBLY MANUFACTURING PROCESS.
P060002|S005|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/22/2009|09/04/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P890003|S173|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK HOME MONITOR MODEL 2490|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/2009|09/25/2009|||APPR|APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING, WITH THE MODEL 2490 MEDTRONIC CARELINK HOME MONITOR.
P980035|S140|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA AND RELIA IPG FAMILIES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/2009|09/25/2009|||APPR|APPROVAL FOR DESIGN CHANGES TO THE L368 INTEGRATED CIRCUIT INCLUDING MODIFICATIONS TO THE CHARGE AMP OFFSET CIRCUIT, AUTOPOLARITY SHORT CIRCUIT PACE THRESHOLD CIRCUIT, AND KEITHLEY STRUCTURE AS WELL AS A FAMILY IDENTIFICATION CHANGE IN THE INTEGRATED CIRCUIT FOR THE RELIA.
P040034|S012|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2009|08/28/2009|||OK30|ALTERNATE SUPPLIER TO PROVIDE THE FUNCTIONALIZED PEG-SG MATERIAL TO THE FIRM FOR USE IN THE MANUFACTURE OF THE DEVICE.
P980022|S058|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP & GUARDIAN REAL-TIME MONITOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2009|08/21/2009|||OK30|CHANGES TO THE ELECTRO LUMINESCENT LAMP (EL LAMP).
P070015|S023|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2009|08/26/2009|||OK30|REPLACEMENT OF THE E-BEAM IRRADIATION EQUIPMENT.
P910031|S026|ABBOTT VASCULAR DEVICES|400 SAGINAW DR.||REDWOOD CITY|CA|94063||Catheters, transluminal coronary angioplasty, percutaneous|NC MERLIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2009|08/26/2009|||OK30|CHANGE IN THE EQUIPMENT USED TO MANUFACTURE THE BALLOONS.
P070009|S005|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND-C|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2009|08/25/2009|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P860057|S059|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS|DYE|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/29/2009|09/18/2009|||APPR|APPROVAL FOR UPDATED LABELING TO REFLECT FINDINGS OF POST-MARKET CLINICAL STUDY 98-1.
P030017|S094|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM (SCS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2009|08/18/2009|||OK30|MODIFICATION TO THE LEAD ASSEMBLY PROCESS.
P880003|S098|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|FIRESTAR RX PTCA BALLOON DILATATION CATHETER AND DURASTAR RX PTCA BALLOON DILATATION CATHETER|LOX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/30/2009|08/13/2009|||APPR|APPROVAL FOR THE MODIFICATION OF A CAUTION STATEMENT IN THE IFU FO THE DEVICE.
P000025|S043|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|SONATATI100 IMPLANT|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/2009|09/23/2009|||APPR|APPROVAL FOR THE CREATION OF A FITTING GUIDE FOR MAESTRO 3.0 AND THE SPEECH PROCESSORS OPUS1 AND OPUS2.
P040014|S011|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION CATHETER|LPB|CV|30-Day Notice||N|07/30/2009|08/28/2009|||OK30|CHANGE IN THE PROXIMAL COMPONENT OF THE ABLATION CATHETERS.
P990064|S028|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/31/2009|09/29/2009|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE DISPOSABLE CINCH AORTIC VALVE HOLDER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CINCH II VALVE HOLDER AND IS INDICATED FOR THE TEMPORARY DEFLECTION OF THE VALVE STENT POSTS TO PROVIDE SURGICAL EASE OF IMPLANTATION OF THE BIOPROSTHESIS.
P040042|S016|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS|OAD|CV|30-Day Notice||N|07/30/2009|08/28/2009|||OK30|CHANGE IN THE PROXIMAL COMPONENT OF THE ABLATION CATHETERS.
P980043|S021|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/31/2009|09/29/2009|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE DISPOSABLE CINCH AORTIC VALVE HOLDER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CINCH II VALVE HOLDER AND IS INDICATED FOR THE TEMPORARY DEFLECTION OF THE VALVE STENT POSTS TO PROVIDE SURGICAL EASE OF IMPLANTATION OF THE BIOPROSTHESIS.
P960028|S032|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|SOFT ACRYLIC INTRAOCULAR LENS|MFK|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2009|06/29/2010|||APPR|APPROVAL FOR A CHANGE IN THE CYCLE TIME FOR THE TUMBLING PROCESS.
P980040|S030|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES/TECNIS 1-PIECE LENS MODEL ZCB00|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2009|06/29/2010|||APPR|APPROVAL FOR A CHANGE IN THE CYCLE TIME FOR THE TUMBLING PROCESS.
P990080|S033|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO TECNIS LENS MODEL ZA9003|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2009|06/29/2010|||APPR|APPROVAL FOR A CHANGE IN THE CYCLE TIME FOR THE TUMBLING PROCESS.
P970029|S014|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS HOLMIUM TMR SYSTEM|MNO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/30/2009|02/22/2012|||APPR|APPROVAL FOR THE PEARL 8.0 HANDPIECE.
P070022|S001|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/04/2009|10/20/2009|||APPR|APPROVAL FOR CHANGING THE ADIANA INSTRUCTIONS FOR USE TO MAKE USE OF THE SPLIT INTRODUCER OPTIONAL.
P040037|S022|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|12/14/2009|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER.
P990023|S007|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/03/2009|||OK30|ALTERNATE MANUFACTURING PROCESS TO AUTOMATE THE LABELING, ASSEMBLY, AND PACKAGING PROCESS.
P950022|S063|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|DURATA, RIATA, RIATA ST, AND RIATA ST OPTIM FAMILY OF LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/04/2009|09/29/2009|||APPR|APPROVAL FOR DESIGN AND PROCESS MODIFICATIONS OF THE DR-1 CONNECTOR PIN ON THE DURATA, RIATA, RIATA ST AND RIATA ST OPTIM FAMILIES OF LEADS.
P960043|S066|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|SUTURE MEDIATED CLOSURE SYSTEMS, PERCUTANEOUS VASCULAR SURGICAL SYSTEMS/ASSOCIATED ACCESSORIES|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|08/24/2009|||OK30|ADDITIONAL EQUIPMENT FOR USE IN THE PACKAGING STATIONS.
P050007|S018|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE/STARCLOSE SE VASCULAR CLOSURE SYSTEMS|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|08/24/2009|||OK30|ADDITIONAL EQUIPMENT FOR USE IN THE PACKAGING STATIONS.
P050007|S019|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/01/2009|||OK30|CHANGE IN THE SUBASSEMBLY BONDING PROCESS.
P950032|S053|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/03/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER INTENDED TO PROVIDE CONSISTENT SUPPLY OF MATERIALS TO PRODUCTION ASSEMBLIES.
P070007|S011|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/01/2009|||OK30|ALTERNATIVE TESTING FACILITY AND CHANGES TO THE SAMPLING PLAN FOR THE FINISHED DEVICE LAL TESTING.
P070027|S010|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/01/2009|||OK30|ALTERNATIVE TESTING FACILITY AND CHANGES TO THE SAMPLING PLAN FOR THE FINISHED DEVICE LAL TESTING.
P990020|S035|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/01/2009|||OK30|ALTERNATIVE TESTING FACILITY AND CHANGES TO THE SAMPLING PLAN FOR THE FINISHED DEVICE LAL TESTING.
P910023|S215|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/2009|01/29/2010|||APPR|APPROVAL FOR THE CURRENT ACCEL ICD MODELS CD2215/CD1215 AND PROMOTE ACCEL CRT-D MODEL CD3215 PULSE GENERATORS AND THE MODEL 3330 VERSION 7.1.2.1.
P040034|S013|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/11/2009|10/09/2009|||APPR|APPROVAL TO IDENTIFY ALTERNATE APPLICATORS FOR USE WITH THE DEVICE.  THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING CRANIAL SURGERY TO PROVIDE WATERTIGHT CLOSURE.
P960013|S048|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL ST LEAD MODEL 1882 LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|08/28/2009|||OK30|ELIMINATION OF THE PLASMA PRIMING PROCESS.
P070014|S003|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/01/2009|||OK30|ADDITION OF AN IN HOUSE SUPPLIER FOR SHEATH COMPONENTS AND EXTENSION OF THE SHELF LIFE FOR A SHEATH COMPONENT.
P030054|S131|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/2009|01/29/2010|||APPR|APPROVAL FOR THE CURRENT ACCEL ICD MODELS CD2215/CD1215 AND PROMOTE ACCEL CRT-D MODEL CD3215 PULSE GENERATORS AND THE MODEL 3330 VERSION 7.1.2.1.
P850007|S029|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM AND SPINAL STIM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/11/2009|||OK30|REPLACEMENT OF THE BATTERY CELL FOR THE LINE OF BONE GROWTH STIMULATORS.
P030034|S003|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL-STIM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2009|09/11/2009|||OK30|REPLACEMENT OF THE BATTERY CELL FOR THE LINE OF BONE GROWTH STIMULATORS.
P050047|S009|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2009|09/04/2009|||OK30|INSTALLATION OF AN ADDITIONAL MANUFACTURING PRODUCTION LINE.
P870025|S009|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|FETAL ACOUSTIC STIMULATOR (FAST)|MCP|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2009|04/23/2010|||APPR|APPROVAL FOR A CHANGE IN SUPPLIER OF A COIL ASSEMBLY.
P060033|S038|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/2009|10/19/2009|||APPR|APPROVAL FOR A 24 MONTH SHELF LIFE FOR ENDEAVOR SPRINT.
P860019|S237|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX PTCA BALLOON DILITATION CATHETER|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2009|09/22/2009|||APPR|APPROVAL FOR CHANGES TO THE BONDING PROCESS.
P980016|S201|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS VR/DR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2009|09/03/2009|||OK30|CHANGES TO THE CAPACITOR STACK ASSEMBLY PROCESS.
P010031|S162|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC II/III MARQUIS ICDS/INSYNC II/III PROTECT ICDS/INTRINSIC ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2009|09/03/2009|||OK30|CHANGES TO THE CAPACITOR STACK ASSEMBLY PROCESS.
P060033|S039|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2009|09/03/2009|||OK30|CHANGE IN THE STORAGE TIME FOR EXPOSED BIOLOGICAL INDICATORS PRIOR TO TESTING.
P900052|S017|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM|LNY|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2009|04/21/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE POST-HOUSING MATERIAL AND THE GUIDEWIRE COATING.
P860004|S111|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II INFUSION PUMP||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2009|09/09/2009|||OK30|AUTOMATING THE STEP WHERE DATA IS TRANSFERRED FROM THE ALARM TEST EQUIPMENT TO FACTORYWORKS, THE MANUFACTURING SOFTWARE THAT CONTROLS THE MANUFACTURING OF THE DEVICE.
P050018|S008|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT SCORING BALLOON CATHETER|NWX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2009|10/08/2009|||APPR|APPROVAL FOR MATERIAL CHANGES TO THE EASY-EXCHANGE (EX) DELIVERY SYSTEM.
P070027|S011|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/2009|02/04/2010|||APPR|APPROVAL FOR ADDING THE TALENT CONVERTER STENT GRAFT AND TALENT OCCLUDER ASLINE EXTENSIONS TO THE ALREADY EXISTING TALENT ABDOMINAL PRODUCT FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT CONVERTER STENT GRAFT SYSTEM WITHXCELERANT HYDRO DELIVERY SYSTEM & TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM. THE TALENT CONVERTER IS INDICATED FOR SECONDARY ENDOVASCULAR INTERVENTION IN PATIENTS HAVING RECEIVED PRIOR ENDOVASCULAR REPAIR OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS USING THE TALENTOR ANEURX BIFURCATED STENT GRAFTS IN WHICH THERE IS INADEQUATE PROXIMAL FIXATION, SEAL, OVERLAPPING OF MODULAR COMPONENTS OR UNATTAINABLE CONTRALATERAL LIMB CANNULATION. THE TALENT OCCLUDER IS INDICATED FOR ENDOLUMINAL OCCLUSION OF THE COMMON ILIAC ARTERY IN ORDER TO PREVENTRETROGRADE BLOOD INTO THE ANEURYSM SAC WHEN USED IN CONJUNCTION TO A FEM-FEM BYPASS.
P050050|S001|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM|NTG|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/05/2009|10/08/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030022|S013|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2009|09/11/2009|||OK30|NEW RAW MATERIAL SUPPLIER MANUFACTURING SITE THAT WILL BE USED TO FORGE THE ANTHOLOGY HIP STEMS ASSOCIATED WITH THE DEVICE.
P860019|S238|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX PTCA BALLOON DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2009|09/08/2009|||OK30|ALTERNATE DISTAL WELDING PROCESS.
P900066|S009|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN PERFLUOROPROPANE C3F8 GAS|LPO|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/2009|01/13/2010|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE CLARIFICATION OF THE GAS PRESSURE RESTRICTION LISTED ON THE GAS CYLINDER LABEL AND ENHANCED INSTRUCTION FOR FILLING A SYRINGE WITH ISPAN PERFLUOROPROPANE C3F8 GAS.
P900067|S006|AIR LIQUIDE|6141 EASTON ROAD|P.O. BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN SULFUR HEXAFLUORIDE SF6 GAS|LPO|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/2009|01/13/2010|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE CLARIFICATION OF THE GAS PRESSURE RESTRICTION LISTED ON THE GAS CYLINDER LABEL AND ENHANCED INSTRUCTION FOR FILLING A SYRINGE WITH ISPAN HEXAFLUORIDE SF6 GAS.
P040013|S015|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENHANCED MATRIX|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2009|11/13/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT LUITPOLD PHARMACEUTICALS, INC., IN SHIRLEY, NEW YORK, FOR THE PACKAGING (KITTING) OF THE GEM 21S.
P000006|S015|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2009|09/11/2009|||OK30|USE OF A DIFFERENT PIECE OF EQUIPMENT DURING THE DIPPING PROCESS.
P020026|S066|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2009|09/14/2009|||OK30|CHANGE TO A STAINLESS STEEL MANUFACTURING AID.
P060033|S040|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/14/2009|10/29/2009|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE.
P040021|S010|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2009|09/16/2009|||OK30|CHANGE IN RAW MATERIAL USED TO MANUFACTURE THE DEVICE.
P040021|S011|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES|LWR|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2009|10/02/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL, WOODRIDGE FACILITY, ST. PAUL, MINNESOTA FOR BIOBURDEN REDUCTION AND CHEMICAL FIXATION OF THE BIOCOR AND EPIC FAMILY OF HEART VALVES.
P010013|S025|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|08/17/2009|10/16/2009|||APPR|APPROVAL FOR THE CHANGES TO THE SHEATH AND CERVICAL COLLAR OF THE NOVASURE DISPOSABLE DEVICE.
P820033|S005|Asahi Kasei Medical Co., Ltd.|1-105 KANDA JINBOCHO|CHIYODA-KU|TOKYO||101-8|8101|Separator for therapeutic purposes, membrane automated blood cell/plasma|PLASMAFLO OP-05W (A)|MDP|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/2009|03/16/2010|||APPR|APPROVAL FOR THE PLASMAFLO OP-05W(A).  THE DEVICE, IS INTENDED AS A REPLACEMENT FOR THE PLASMAFLO AP-05H AND THE PLASMAFLO AP-05H(L).  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME PLASMAFLO OP-05W(A) AND IS INDICATED FOR USE IN THERAPEUTIC PROCEDURES REQUIRING SEPARATION OF PLASMA FROM WHOLE BLOOD.
P960040|S203|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2009|09/16/2009|||OK30|ADDITION OF A NEW CATHODE SHEET MANUFACTURING PROCESS.
P010012|S218|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2009|09/16/2009|||OK30|ADDITION OF A NEW CATHODE SHEET MANUFACTURING PROCESS.
P980023|S038|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX SMART STEROID-ELUTING DUAL-COIL ICD LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2009|09/17/2010|||APPR|APPROVAL FOR LINOX SMART STEROID-ELUTING DUAL COIL ICD LEADS WITH SILGLIDE COATING.
P050039|S003|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2009|09/30/2009|||OK30|CHANGE FROM PERFORMING FLUORESCENT PENETRANT INSPECTION (FPI) AT QC LABS TO PERFORMING THE INSPECTION STEP IN-HOUSE AS WELL AS A PROCESS CHANGE AT CERAMTEC.
P030050|S005|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AESTHETIC|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/19/2009|03/05/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960013|S049|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL 1888 LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2009|09/17/2009|||OK30|ADDITION OF AN OVEN CURING STEP.
P010023|S002|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/19/2009|10/08/2009|||APPR|APPROVAL TO CHANGE THE LABELING WITH A NEW PRODUCT NAME, MAXUM SYSTEM
P040037|S023|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS (WITH HEPARIN BIOACTIVE SURFACE)|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2009|09/17/2009|||OK30|DISCONTINUANCE OF A REDUNDANT ACCEPTANCE ACTIVITY.
P050007|S020|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2009|09/14/2009|||OK30|CHANGE FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS AT THE WIRE CONTROLLER ASSEMBLY STATION.
P840001|S140|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2009|09/16/2009|||OK30|TRANSFER OF QUADRAFILAR COILS SUPPLIER MANUFACTURING SITE FROM HERAEUS LINO LAKES, MINNESOTA TO DORADO, PUERTO RICO.
P960009|S069|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2009|09/16/2009|||OK30|TRANSFER OF QUADRAFILAR COILS SUPPLIER MANUFACTURING SITE FROM HERAEUS LINO LAKES, MINNESOTA TO DORADO, PUERTO RICO.
P050012|S019|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2009|09/17/2009|||OK30|ADDING AN ADDITIONAL SUPPLIER FOR THE DEXCOM APPLICATOR NEEDLES.
P030029|S008|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR AHBS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2009|09/15/2009|||OK30|CHANGE FROM 20 GRAMS TO 60 GRAMS FOR THE ANTI-HBS WETCAKE USED IN THE PRODUCTION OF AHBS REAGENT.
P860004|S112|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED II INFUSION SYSTEM||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2009|09/18/2009|||OK30|AUTOMATION OF THE TRANSFER OF FINAL FUNCTIONAL TEST DATA TO FACTORYWORKS, THE MANUFACTURING SOFTWARE THAT CONTROLS THE MANUFACTURING OF THE DEVICE.
P980016|S202|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO/VIRTUOSO II/SECURA/MAXIMO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2009|09/18/2009|||OK30|MODIFICATIONS TO A FINAL DEVICE TEST.
P010031|S163|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2009|09/18/2009|||OK30|MODIFICATIONS TO A FINAL DEVICE TEST.
P050050|S002|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM|NTG|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/21/2009|12/27/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910073|S079|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2009|09/22/2009|||OK30|REPLACING THE AUTOMATED OPTICAL MEASURING SYSTEM.
P020052|S005|St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT|MTE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2009|09/22/2009|||OK30|CHANGE IN THE STERILIZATION LOAD.
P970004|S075|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF NEUROSTIMULATION LEADS|EZW|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2009|10/15/2009|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA FOR THE MANUFACTURE OF THE MEDTRONIC MODEL 3625 TEST STIMULATOR.
P960009|S070|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS|MHY|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2009|10/15/2009|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA FOR THE MANUFACTURE OF THE MEDTRONIC MODEL 3625 TEST STIMULATOR.
P840001|S141|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2009|10/15/2009|||APPR|APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA FOR THE MANUFACTURE OF THE MEDTRONIC MODEL 3625 TEST STIMULATOR.
P040027|S017|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2009|09/23/2009|||OK30|REMOVAL OF THE ZIPPER COMPONENT PROCESS.
P040037|S024|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice||N|08/25/2009|09/23/2009|||OK30|REMOVAL OF THE ZIPPER COMPONENT PROCESS.
P960013|S050|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL 1888 LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2009|09/17/2009|||OK30|ALTERNATE SUPPLIER OF OUTER TUBING FOR USE IN THE MANUFACTURING OF THE LEADS.
P060022|S005|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2009|10/08/2009|||OK30|ELIMINATION OF TWO MANUFACTURING MATERIALS AND ONE MANUFACTURING PROCESS AT THE CLEARWATER, FLORIDA FACILITY.
P050012|S020|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2009|09/23/2009|||OK30|CHANGE TO THE PROCESS FOR APPLYING THE ELECTRODE LAYER OF THE SENSOR COMPONENT.
P030002|S021|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODELS AT50AO AND AT52AO ACCOMMODATING INTRAOCULAR LENS (IOL)|NAA|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/26/2009|10/23/2009|||APPR|APPROVAL FOR THE ADDITION OF AN ASPHERIC SURFACE TO THE APPROVED PARENT CRYSTALENS IOL MODEL AT-45.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS MODELS AT50AO AND AT52AO AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND IS INTENDED TO PROVIDE NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT SPECTACLES.
P980044|S010|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2009|09/25/2009|||OK30|REPLACEMENT OF THE FILTER INTEGRITY TESTING INSTRUMENT WITH A NEWER MODEL OF THE INSTRUMENT.
P060039|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN STARFIX LEAD|OJX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/27/2009|02/02/2010|||APPR|APPROVAL FOR SHELF LIFE EXTENSION FROM 18 TO 24 MONTHS FOR THE ATTAIN STARFIX LEAD MODEL 4195.
P050020|S019|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2009|09/21/2009|||OK30|ADDING AN ALTERNATE MANUFACTURER FOR THE INSERTER ASSEMBLY PROCESS.
P060033|S041|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2009|09/15/2009|||OK30|IMPLEMENTATION OF AN ALTERNATE PRODUCTION AID.
P030009|S035|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2009|09/15/2009|||OK30|IMPLEMENTATION OF AN ALTERNATE PRODUCTION AID.
P960058|S082|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/2009|03/30/2010|||APPR|APPROVAL FOR A NEW VERSION OF FITTING SOFTWARE, CALLED SOUNDWAVE 1.6.
P950022|S064|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA/RIATA ST & DURATA FAMILIES OF LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2009|09/25/2009|||OK30|CHANGE IN TEMPERATURE AND HUMIDITY CURE OPERATION.
P960013|S051|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL/TENDRIL ST & OPTISENSE FAMILIES OF LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2009|09/25/2009|||OK30|CHANGE IN TEMPERATURE AND HUMIDITY CURE OPERATION.
P960030|S027|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFELX OPTIM FAMILIES OF LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2009|09/25/2009|||OK30|CHANGE IN TEMPERATURE AND HUMIDITY CURE OPERATION.
P030035|S058|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|AESCULA FAMILY OF LEFT HEART LEADS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2009|09/25/2009|||OK30|CHANGE IN TEMPERATURE AND HUMIDITY CURE OPERATION.
P030054|S132|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE/QUICKFLEX FAMILIES OF LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2009|09/25/2009|||OK30|CHANGE IN TEMPERATURE AND HUMIDITY CURE OPERATION.
P960009|S071|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC NEUROSTIMULATOR|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2009|10/27/2009|||APPR|APPROVAL FOR REDESIGN OF THE 6-PIN FILTERED FEEDTHROUGH.
P970029|S015|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TMR SYSTEM|MNO|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/31/2009|10/20/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960013|S052|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL LEADS|NVN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2009|01/20/2010|||APPR|APPROVAL FOR A NEW LEAD COMPONENT SUPPLIER.
P990040|S009|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2009|02/25/2010|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT CODMAN & SHURTLEFF, INC. IN RAYNHAM, MASSACHUSETTS AND BRIDGEWATER, MASSACHUSETTS.
P060008|S019|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2009|09/30/2009|||OK30|ELIMINATION OF AN IN-PROCESS CLEANING OF COMPONENTS FOR THE DEVICE.
P040016|S036|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE' CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2009|09/30/2009|||OK30|ELIMINATION OF AN IN-PROCESS CLEANING OF COMPONENTS FOR THE DEVICE.
P030025|S064|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2009|09/30/2009|||OK30|ELIMINATION OF AN IN-PROCESS CLEANING OF COMPONENTS FOR THE DEVICE.
P020009|S050|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2009|09/30/2009|||OK30|ELIMINATION OF AN IN-PROCESS CLEANING OF COMPONENTS FOR THE DEVICE.
P860019|S240|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM MAVERICK PTCA CATHETER/MAVERICK OTW PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2009|09/30/2009|||OK30|ELIMINATION OF AN IN-PROCESS CLEANING OF COMPONENTS FOR THE DEVICE.
P950020|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON OTW PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2009|09/30/2009|||OK30|ELIMINATION OF AN IN-PROCESS CLEANING OF COMPONENTS FOR THE DEVICE.
P000058|S034|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2009|01/14/2010|||APPR|APPROVAL FOR THE REMOVAL OF ELLMAN¿S ASSAY AND SDS-PAGE SILVER STAIN TESTS FROM THE RHBMP-2 DRUG SUBSTANCE RELEASE SPECIFICATION.
P000054|S023|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2009|01/14/2010|||APPR|APPROVAL FOR THE REMOVAL OF ELLMAN¿S ASSAY AND SDS-PAGE SILVER STAIN TESTS FROM THE RHBMP-2 DRUG SUBSTANCE RELEASE SPECIFICATION.
P050053|S013|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2009|01/14/2010|||APPR|APPROVAL FOR THE REMOVAL OF ELLMAN¿S ASSAY AND SDS-PAGE SILVER STAIN TESTS FROM THE RHBMP-2 DRUG SUBSTANCE RELEASE SPECIFICATION.
P910023|S216|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/01/2009|11/13/2009|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER AND ASSOCIATED DESIGN CHANGES FOR THE ANTENNA PRINTED CIRCUIT BOARD (PCB) FOR THE MERLIN@HOME MODEL EX1150 TRANSMITTER.
P030054|S133|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/01/2009|11/13/2009|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER AND ASSOCIATED DESIGN CHANGES FOR THE ANTENNA PRINTED CIRCUIT BOARD (PCB) FOR THE MERLIN@HOME MODEL EX1150 TRANSMITTER.
P010014|S024|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (OXFORD PARTIAL KNEE SYSTEM)|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2009|03/17/2010|||APPR|APPROVAL FOR NEW HEATING EQUIPMENT BEING INTRODUCED TO SEAL BLISTER PACKAGES, WHICH CONTAIN THE OXFORD® PARTIAL KNEE IMPLANTS.
P040002|S025|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/2009|09/16/2009|||APPR|APPROVAL FOR CHANGES MADE TO THE LABELING TO INCLUDE INSTRUCTIONS FOR THE OPTION OF DEPLOYING OF THE IPSILATERAL LEG FIRST.
P050044|S010|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2009|10/01/2009|||OK30|CHANGE IN SHELF LIFE.
P000039|S032|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/01/2009|10/01/2009|||APPR|APPROVAL FOR LABELING CHANGES.
P960016|S024|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC & SAFIRE CARDIAC ABLATION SYSTEMS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2009|09/30/2009|||OK30|REPLACEMENT OF THE HORIZON TEST SYSTEM WITH THE CIRRIS TOUCH 1 ELECTRICAL TEST SYSTEM.
P980022|S059|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MMT-7002 & MMT-7003 GLUCOSE SENSORS ( AUTOMATED BICARBONATE BUFFER TEST SYSTEM)|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2009|10/01/2009|||OK30|REPLACING THE MANUAL BUFFER TEST SYSTEM WITH AN AUTOMATED BUFFER TEST SYSTEM.
P020026|S067|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2009|09/18/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P040020|S020|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR MULTIFOCAL INTRACULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2009|10/01/2009|||OK30|CHANGING TO A BUILDING MANAGEMENT SYSTEM FOR THE ENVIRONMENTALLY CONTROLLED AREAS.
P030054|S134|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2009|10/02/2009|||OK30|CHANGE IN AGING TIME FOR HIGH VOLTAGE CAPACITORS.
P910023|S217|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2009|10/02/2009|||OK30|CHANGE IN AGING TIME FOR HIGH VOLTAGE CAPACITORS.
P060033|S042|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/02/2009|10/30/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030039|S014|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2009|12/18/2009|||APPR|APPROVAL FOR A CHANGE IN THE MATERIALS USED TO MAKE THE SYRINGE THAT HOLDS THE POLYETHYLENE GLYCOL (PIG) POLYMERS.
P870072|S042|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|TLC-II  PLUS PORTABLE VAD DRIVER|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2009|11/05/2009|||APPR|APPROVAL FOR INCREASING THE SERVICE INTERVAL FOR THE TLC-IIPLUS PORTABLE VAD DRIVER FROM 3000 HOURS TO 4500 HOURS.
P860019|S241|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2009|04/16/2010|||APPR|APPROVAL FOR: 1) A NEW BALLOON AND MARKERBAND MATERIALS; 2) EXTENSION OF THE PRODUCT MATRIX TO INCLUDE A 6MM LENGTH; 3) AN ALTERNATE BOND FOR MONORAIL MODELS; AND 4) A CHANGE IN THE HYDROPHILIC COATING LENGTH ON OVER-THE-WIRE MODELS.
P000014|S019|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2009|01/11/2010|||APPR|APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE VITROSIMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDERTHE TRADE NAMES VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATOR, AND IS INDICATED FOR:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK:FOR THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS(HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATIONSTATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THELABORATORY' DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS, IN WHOMETIOLOGY IS UNKNOWN.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUMUSING THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK.
P050033|S008|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|ELEVESS|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/2009|05/24/2010|||APPR|APPROVAL FOR REVISION OF THE PHYSICIAN AND PATIENT LABELS TO INCLUDE UPDATES ON THE POST MARKET ADVERSE EVENT EXPERIENCE WITH THE DEVICE.
P060033|S043|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|12/10/2010|||APPR|APPROVAL FOR AN UPDATE TO ABBOTT LABORATORIES¿ DRUG COMPONENT.
P070014|S004|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/01/2009|||OK30|CHANGE A MANDREL USED AS A MANUFACTURING AID.
P070009|S006|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND-C|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/06/2009|||OK30|ADDITION OF AN IN-HOUSE MANUFACTURING SITE FOR A DEVICE COMPONENT AS WELL AS CHANGES TO SEVERAL MANUFACTURING STEPS.
P890003|S174|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODEL 2490C CARELINK MONITORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|CHANGES TO TWO TESTS IN THE FINAL PRODUCT TEST SYSTEM.
P970018|S018|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|04/02/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIPATH IMAGING, INC., MEBANE, NORTH CAROLINA.
P980035|S141|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA IPG FAMILY/RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|MULTIPLE PROCESS FLOW CHANGES.
P010031|S164|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||MAXIMO II CRT-D/CONSULTA CRT-D/CONCERTO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|MULTIPLE PROCESS FLOW CHANGES.
P980016|S203|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|MULTIPLE PROCESS FLOW CHANGES.
P980035|S142|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P970012|S057|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P980016|S204|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INSTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P990001|S056|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CLARITY DDDR, CLARITY SSIR, DIAMOND III, RUBY III, TOPAZ III, JADE III, VITA 2 DDDR, C-SERIES, AND T-SERIES FAMILY OF IP|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P010015|S072|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P/INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P010031|S165|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/CONCERTO/II CRT-D/MAXIMO II/CONSULTA CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2009|10/08/2009|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P010055|S007|PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTALUND CORETHERM SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/2009|01/29/2014|||APPR|APPROVAL FOR MODIFICATION OF THE INDICATIONS FOR USE AND ASSOCIATED MODIFICATIONS TO THE CATHETER, ANTENNA, AND TEMPERATURE PROBE FOR PATIENTS WITH PROSTATES SMALLER THAN CURRENTLY INDICATED. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CORETHERMACCESSORIES FOR SMALL PROSTATES AND IS INDICATED FOR USE TOGETHER WITH PROSTALUND CORETHERM /SE IN PATIENTS WITH GLANDS SIZE 20-50G AND WITH A PROSTATE LENGTH ¿25 MM.
P020026|S068|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2009|10/09/2009|||OK30|DISCONTINUATION OF A REDUNDANT INSPECTION.
P950037|S073|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|HOME MONITORING SERVICE CENTER 3 - VERSION 3.6|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/10/2009|10/22/2009|||APPR|APPROVAL FOR VERSION 3.6 OF THE HOME MONITORING SERVICE CENTER 3.
P000009|S036|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|HOME MONITORING SERVICE CENTER 3 - VERSION 3.6|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/10/2009|10/22/2009|||APPR|APPROVAL FOR VERSION 3.6 OF THE HOME MONITORING SERVICE CENTER 3.
P050023|S026|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|HOME MONITORING SERVICE CENTER 3 - VERSION 3.6|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/10/2009|10/22/2009|||APPR|APPROVAL FOR VERSION 3.6 OF THE HOME MONITORING SERVICE CENTER 3.
P070008|S012|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|HOME MONITORING SERVICE CENTER 3 - VERSION 3.6|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/10/2009|10/22/2009|||APPR|APPROVAL FOR VERSION 3.6 OF THE HOME MONITORING SERVICE CENTER 3.
P050007|S021|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSURE SE VASCULAR  CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2009|09/18/2009|||OK30|OUTSOURCING A SUBASSEMBLY AND REMOVAL OF A MANUFACTURING STEP.
P050007|S022|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSURE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2009|10/08/2009|||OK30|ALTERNATIVE SEMI-AUTOMATED MANUFACTURING PROCESS.
P030032|S009|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|PREVELLE SILK & HYLAN B GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2009|10/09/2009|||OK30|CHANGE IN SOLUTION SAMPLING AND A CHANGE IN SILK BULK PRODUCTION.
P990020|S036|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2009|01/21/2010|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING LOCATION OF THE DEVICE WITHIN THE MEDTRONIC IRELAND CAMPUS.
P910001|S033|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/11/2009|07/08/2010|||APPR|APPROVAL FOR CHANGES TO THE CVX-300 EXCIMER LASER SYSTEM FOR COMPLIANCE TO ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY VOLUNTARY STANDARDS.
P980035|S143|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2009|10/08/2009|||OK30|CHANGES TO THE EPOXY DISPENSER EQUIPMENT.
P040048|S009|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/14/2009|06/04/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030054|S135|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2009|03/16/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P910023|S218|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2009|10/14/2009|||OK30|CHANGES TO THE SUPPLIER FOR THE ISOTRANSFORMER MODULE (ITM) AND THE 64 K TELEMETRY COIL.
P030054|S136|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2009|10/14/2009|||OK30|CHANGES TO THE SUPPLIER FOR THE ISOTRANSFORMER MODULE (ITM) AND THE 64 K TELEMETRY COIL.
P030035|S059|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER / FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2009|03/16/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880006|S064|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2009|03/16/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880086|S178|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY / INTEGRITY /VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2009|03/16/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P910023|S219|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2009|03/16/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970013|S031|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2009|03/16/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P840064|S041|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2009|10/15/2009|||OK30|ALTERNATE PROCESS TO AUTOMATE THE REVIEW AND DOCUMENTATION OF LABORATORY AND PROCESS TEST RESULTS AS PART OF THE ELECTRONIC BATCH RECORD (EBR) SYSTEM.
P890047|S029|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2009|10/15/2009|||OK30|ALTERNATE PROCESS TO AUTOMATE THE REVIEW AND DOCUMENTATION OF LABORATORY AND PROCESS TEST RESULTS AS PART OF THE ELECTRONIC BATCH RECORD (EBR) SYSTEM.
P990023|S008|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2009|10/15/2009|||OK30|ALTERNATE PROCESS TO AUTOMATE THE REVIEW AND DOCUMENTATION OF LABORATORY AND PROCESS TEST RESULTS AS PART OF THE ELECTRONIC BATCH RECORD (EBR) SYSTEM.
P040016|S037|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX FOR LIBERTE BARE METAL STENTS|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/2009|09/25/2009|||APPR|APPROVAL TO ADD AN ALTERNATE TRADE NAME FOR THE LIBERTÉ MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VERIFLEX BARE METAL CORONARY STENT AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <28 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.75 TO 5.00 MM.
P030017|S095|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track||N|09/15/2009|06/01/2010|||APPR|APPROVAL FOR AN UPDATE TO THE CLINICIAN PROGRAMMER TABLET LAPTOP (TOSHIBA MODEL M750) COMPUTER.
P060030|S005|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP / COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2009|10/13/2009|||OK30|INCREASE IN THE MAXIMUM BULK BATCH SIZE FOR THE LOW POSITIVE CONTROL AND THE HIGH POSITIVE CONTROLS AND TO ELIMINATE REDUNDANT IN-PROCESS TESTING USED IN THE PREPARATION OF THE LOW AND HIGH POSITIVE CONTROLS.
P070015|S024|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2009|10/14/2009|||OK30|CHANGE TO THE XIENCE V STENT LASER CUTTING PROCESS.
P050039|S004|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|NOVATION CERAMIC ARTICULATION HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/15/2009|12/09/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910023|S220|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/16/2009|10/22/2009|||APPR|APPROVAL FOR MERLIN.NET SOFTWARE VERSION 4.1.
P850022|S017|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM & SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/16/2009|10/15/2010|||APPR|APPROVAL FOR CHANGES TO THE HARDWARE, SOFTWARE, COMPONENTS, AND SPECIFICATIONSOF THE DEVICE.
P020049|S001|LEMAITRE VASCULAR INC|63 SECOND AVENUE||BURLINGTON|MA|01803||TISSUE GRAFT OF 6MM AND GREATER|PROCOL VASCULAR BIOPROSTHESIS|LXA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2009|10/08/2009|||OK30|ALTERNATE ABATTOIR.
P050006|S014|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/2009|01/05/2011|||APPR|APPROVAL FOR UPDATED DEVICE LABELING.
P990020|S037|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2009|10/23/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC CARDIAC SURGERY, MEDTRONIC PERFUSION SYSTEMS, MINNEAPOLIS, MINNESOTA.  THE PROPOSED SITE WILL BE PERFORMING REWORK OF PACKAGING AND LABELING.
P070027|S012|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2009|10/23/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC CARDIAC SURGERY, MEDTRONIC PERFUSION SYSTEMS, MINNEAPOLIS, MINNESOTA.  THE PROPOSED SITE WILL BE PERFORMING REWORK OF PACKAGING AND LABELING.
P070007|S012|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2009|10/23/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC CARDIAC SURGERY, MEDTRONIC PERFUSION SYSTEMS, MINNEAPOLIS, MINNESOTA.  THE PROPOSED SITE WILL BE PERFORMING REWORK OF PACKAGING AND LABELING.
P930016|S032|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/18/2009|03/09/2010|||APPR|APPROVAL FOR SOFTWARE VERSION 4.70 (STAR S4) AND VERSION 5.30 (STAR S4 IR).
P070015|S025|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2009|10/21/2009|||OK30|MODIFICATION TO THE PROCESS FOR APPLYING THE PRIMER AND DRUG SOLUTION TO THE STENT.
P980016|S206|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II VR/DR|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2009|02/03/2010|||APPR|APPROVAL FOR A CHANGE IN MANUFACTURING TEST SOFTWARE AND TEST REQUIREMENTS.
P010031|S167|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2009|02/03/2010|||APPR|APPROVAL FOR A CHANGE IN MANUFACTURING TEST SOFTWARE AND TEST REQUIREMENTS.
P960040|S204|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN/CONFIENT/VITALITY PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2009|10/21/2009|||OK30|CHANGES TO THE ANODE BURN INSPECTION PROCESS.
P010012|S219|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS/LIVIAN/CONTAK RENEWAL/CONTAK RENEWAL 3 RF|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2009|10/21/2009|||OK30|CHANGES TO THE ANODE BURN INSPECTION PROCESS.
P070015|S026|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2009|10/21/2009|||OK30|NEW BAR SEALER.
P960043|S067|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE MEDIATED SYSTEM/PERCLOSE A T 6F SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2009|10/21/2009|||OK30|CHANGE TO A COMPONENT OF THE SHEATH TRANSITIONING EQUIPMENT.
P050044|S011|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2009|10/23/2009|||OK30|CHANGE TO INCORPORATE ASEPTIC EXPANSION INTO AN EXISTING PRODUCTION LINE.
P970008|S046|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2009|10/22/2009|||OK30|RELOCATION OF AN IN-PROCESS TEST FOR A COMPONENT FROM THE CONTROLLED ENVIRONMENT AREA TO ANOTHER IN-PROCESS ROOM.
N18033|S043|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2009|10/22/2009|||OK30|ALTERNATE TEST METHOD FOR THE VISTAKON (ETAFILCON A) CONTACT LENS MATERIAL.
P980049|S050|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR MODEL 8250 & DR MODEL 8550|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2009|04/07/2010|||APPR|APPROVAL FOR THE PARADYM VR MODEL 8250 AND DR MODEL 8550 WITH SMARTVIEW 2.18UG1 PROGRAMMER SOFTWARE AND THE PARADYM CRT-D MODEL 8750 WITH HARDWARE ANDMANUFACTURING CHANGES AND LABELING AND PROGRAMMER SOFTWARE CHANGES TO THE OVATIO VRMODEL 6250, DR MODEL 6550 AND CRT-D MODEL 6750. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PARADYM VR MODEL 8250 AND PARADYM DR MODEL 8550 WITHSMARTVIEW 2.18UG1 AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIACDEATH DUE TO VENTRICULAR TACHYARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWINGSITUATIONS: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST MANIFESTED BY THE LOSS OFCONSCIOUSNESS) DUE TO VENTRICULAR TACHYARRHYTHMIA, RECURRENT POORLY TOLERATED SUSTAINEDVENTRICULAR TACHYCARDIA.
P060027|S015|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D MODEL 8750|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2009|04/07/2010|||APPR|APPROVAL FOR THE PARADYM VR MODEL 8250 AND DR MODEL 8550 WITH SMARTVIEW 2.18UG1 PROGRAMMER SOFTWARE AND THE PARADYM CRT-D MODEL 8750 WITH HARDWARE ANDMANUFACTURING CHANGES AND LABELING AND PROGRAMMER SOFTWARE CHANGES TO THE OVATIO VRMODEL 6250, DR MODEL 6550 AND CRT-D MODEL 6750. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PARADYM VR MODEL 8250 AND PARADYM DR MODEL 8550 WITHSMARTVIEW 2.18UG1 AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIACDEATH DUE TO VENTRICULAR TACHYARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWINGSITUATIONS: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST MANIFESTED BY THE LOSS OFCONSCIOUSNESS) DUE TO VENTRICULAR TACHYARRHYTHMIA, RECURRENT POORLY TOLERATED SUSTAINEDVENTRICULAR TACHYCARDIA.
P040001|S015|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS SPACER SYSTEM|NQO|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/2009|10/21/2009|||APPR|APPROVAL FOR CHANGES TO THE DEVICE NAME, INSTRUCTIONS FOR USE, AND PHYSICIAN¿S AND PATIENT¿S GUIDES.
P040043|S031|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2009|03/23/2010|||APPR|APPROVAL FOR ADDING THE 45MM TAG THORACIC ENDOPROSTHESIS TO THE ALREADY EXISTING TAG THORACIC ENDOPROSTHESIS PRODUCT FAMILY.  THE TAG DEVICE IS INDICATED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING ADEQUATE ILIAC/ FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 23-42MM, AND >=2CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.
P970051|S053|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2009|06/03/2010|||APPR|APPROVAL FOR THE COMPACT (A26) AND STANDARD (A27) LITHIUM-ION RECHARGEABLE BATTERIES FOR USE WITH THE CP810 SOUND PROCESSOR IN THE BEHIND-THE-EAR (BTE) CONFIGURATION.
P060034|S004|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC IGM EIA|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2009|08/02/2010|||APPR|APPROVAL FOR EXPANDING THE INTENDED USE TO INCLUDE USE WITH THE EVOLISAUTOMATED MICROPLATE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMEMONOLISA ANTI-HBC IGM EIA AND IS INDICATED FOR USE IN THE QUALITATIVE DETECTION OF IGMANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUMEDTA, SODIUM CITRATE, ACD [ACID CITRATE DEXTROSE], LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. THE MONOLISA ANTI-HBC IGM IS INTENDED FORMANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OFIGM ANTIBODIES TO HEPATITIS B VIRUS.
P030029|S009|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS (AHBS)|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2009|09/01/2010|||APPR|APPROVAL FOR ADDING QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA TO THE INTENDED USE.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA® CENTAUR ANTI-HBS(AHBS) ASSAY ON CENTAUR CP AND IS INDICATED FOR:ADVIA® CENTAUR ANTI-HBS (AHBS) ASSAY ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACEANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THEDETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TOOR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAYBE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASEASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.
P050048|S004|BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBS EIA|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2009|04/25/2011|||APPR|APPROVAL FOR USE OF THE MONOLISA ANTI-HBS EIA ON THE EVOLIS AUTOMATED MICROPLATE SYSTEM, ADDING LITHIUM HEPARIN AND SODIUM HEPARIN TO THE LIST OF ACCEPTABLE PLASMA SPECIMEN TYPES, A CHANGE IN THE DYE COLOR IN THE CUTOFF CALIBRATOR, REVISION TO THE SPECIMEN STORAGE REQUIREMENTS, AND MODIFICATION OF THE STORAGE INSTRUCTIONS FOR THE WORKING CONJUGATE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MONOLISA ANTI-HBS EIA AND IS INDICATED FOR THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND EDTA, HEPARIN, OR CITRATED PLASMA.  THE ASSAY RESULTS MAY BE USED AS AN AIDE IN THE DETERMINATION OF SUSCEPTIBILITY OF HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.  THE MONOLISA ANTI-HBS EIA IS INTENDED FOR MANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN.
P060031|S003|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC EIA|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2009|12/30/2010|||APPR|APPROVAL FOR USE ON THE EVOLIS AUTOMATED MICROPLATE SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIO-RAD MONOLISA ANTI-HBC EIA AND IS INDICATED FOR:  THE MONOLISA ANTI-HBC EIA IS AN ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF TOTAL ANTIBODIES (IGG/IGM) TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, SODIUM CITRATE, ACD (ACID CITRATE DEXTROSE), LITHIUM HEPARIN AND SODIUM HEPARIN).  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  THE MONOLISA ANTI-HBC EIA IS INTENDED FOR MANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B VIRUS.
P050023|S027|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILIES OF ICDS & CRT-DS|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2009|03/05/2010|||APPR|APPROVAL FOR A CHANGE IN THE SUPPLIER OF RAW MATERIALS USED TO MANUFACTURE BATTERIES.
P980022|S060|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MMT-7002 & MMT-7003 GLUCOSE SENSORS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2009|10/28/2009|||OK30|REPLACING THE PUDDLE CASTING PROCESS WITH A SLOT COATING PROCESS AND IMPLEMENTATION OF A HEAT TREATMENT PROCESS FOR THE O-RINGS.
P950029|S047|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY SR/DR, RHAPSODY SR/DR, REPLY SR/DR, AND ESPRIT SR/DR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2009|10/28/2009|||OK30|CHANGE IN THE LOCATION FOR MANUFACTURING THE HYBRID ELECTRONIC MODULAR COMPONENT.
P960040|S205|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2009|10/28/2009|||OK30|CHANGES TO THE ALLOWABLE UPPER TIME LIMIT FOR THE SHELF BAKE PROCESS.
P010012|S220|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2009|10/28/2009|||OK30|CHANGES TO THE ALLOWABLE UPPER TIME LIMIT FOR THE SHELF BAKE PROCESS.
P030035|S061|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2009|10/28/2009|||OK30|CHANGE IN THE TEST COVERAGE RANGE FOR THE GIANT MAGNETO RESISTANCE (GMR) COMPONENT.
P880086|S180|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2009|10/28/2009|||OK30|CHANGE IN THE TEST COVERAGE RANGE FOR THE GIANT MAGNETO RESISTANCE (GMR) COMPONENT.
P950005|S028|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2009|11/25/2009|||APPR|APPROVAL FOR CHANGES IN LABELING TO REMOVE A STATEMENT EXCLUDING USE WITH THE STEREOTAXIS CARDIODRIVE CATHETER ADVANCEMENT SYSTEM.
P990025|S021|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2009|11/25/2009|||APPR|APPROVAL FOR CHANGES IN LABELING TO REMOVE A STATEMENT EXCLUDING USE WITH THE STEREOTAXIS CARDIODRIVE CATHETER ADVANCEMENT SYSTEM.
P010068|S017|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR RMT DS|OAD|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2009|11/25/2009|||APPR|APPROVAL FOR CHANGES IN LABELING TO REMOVE A STATEMENT EXCLUDING USE WITH THE STEREOTAXIS CARDIODRIVE CATHETER ADVANCEMENT SYSTEM.
P030031|S018|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2009|11/25/2009|||APPR|APPROVAL FOR CHANGES IN LABELING TO REMOVE A STATEMENT EXCLUDING USE WITH THE STEREOTAXIS CARDIODRIVE CATHETER ADVANCEMENT SYSTEM.
P040036|S013|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2009|11/25/2009|||APPR|APPROVAL FOR CHANGES IN LABELING TO REMOVE A STATEMENT EXCLUDING USE WITH THE STEREOTAXIS CARDIODRIVE CATHETER ADVANCEMENT SYSTEM.
P020016|S003|BIOMET MICROFIXATION, INC.|1520 TRADEPORT DR.||JACKSONVILLE|FL|32218||Joint, temporomandibular, implant|TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM|LZD|DE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/24/2009|10/21/2009|||APPR|APPROVAL FOR A STAND-ALONE SURGICAL TECHNIQUE MANUAL.
P980022|S061|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR GLUCOSE SENSORS|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2009|11/05/2009|||APPR|APPROVAL FOR THE REPLACEMENT OF THE CURRENT SOF-SENSOR GLUCOSE SENSOR MMT-7002 AND MMT-7003 POUCH WITH A SIMILAR ONE BY SUPPLIER TOLAS HEALTHCARE.  THE DIFFERENCE BETWEEN THE TWO POUCHES IS THAT THE BOTTOM WEB OF THE POUCH IS CHANGED FROM P/N TPF-0521 TO P/N TPF-0521 NC DUE TO THE CHANGE OF THE SUPPLIER FOR TOLAS HEALTHCARE.
P940016|S013|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2009|07/22/2010|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE PLASMAT SECURA SYSTEM INCLUDING THE USE OF THE PLASMAT FUTURA MACHINE WITH SOFTWARE VERSION 2.6.01, THE FUTURA KIT, AND INDIVIDUALLY PACKAGED COMPONENTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM AND IS INDICATED FOR ACUTELY REMOVING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) FROM THE PLASMA OF THE FOLLOWING HIGH-RISK PATIENT POPULATIONS FOR WHOM DIET HAS BEEN INEFFECTIVE AND MAXIMUM DRUG THERAPY HAS EITHER BEEN INEFFECTIVE OR NOT TOLERATED:GROUP A: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 500 MG/DL; GROUP B: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 300 MG/DL; AND GROUP C: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 200 MG/DL AND DOCUMENTED CORONARY ARTERY DISEASE.
P040044|S019|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2009|10/16/2009|||OK30|MANUFACTURING PROCESS CHANGE.
P000029|S057|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2009|10/30/2009|||OK30|MODIFICATION OF THE SANITIZATION PROCESS FOR THE WATER FOR INJECTION (WFI) AND PURIFIED WATER (PW) SYSTEMS AND TO REDUCE THE FREQUENCY OF CERTAIN PERIODIC REVIEWS.
P000029|S058|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2009|10/30/2009|||OK30|CHANGE TO THE METHOD OF PREPARING GARMENTS TO BE WORN BY OPERATORS IN THE CLEAN ROOM.
P000029|S059|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2009|10/30/2009|||OK30|ALTERNATE METHOD FOR ANALYSIS OF BACTERIAL ENDOTOXINS IN WFI AND CLEAN STEAM.
P980022|S062|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MMT-7002 & MMT-7003 GLUCOSE SENSORS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2009|10/29/2009|||OK30|CHANGE TO ELIMINATE PLASMA CLEANING AND USE ONLY AN RF ETCHING PROCESS.
P030050|S006|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/09/2009|12/02/2009|||APPR|APPROVAL FOR REVISION OF THE SCULPTRA PHYSICIAN AND PATIENT LABELING.
P020026|S069|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2009|10/30/2009|||OK30|ADDITION OF AN IN-PROCESS SAMPLING PLAN.
P000044|S022|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2009|10/20/2009|||OK30|ADDITION OF A NEW SUPPLIER FOR A RAW MATERIAL FOR THE HUMAN DEFIBRINATED ANTI-HBS POSITIVE PLASMA USED IN THE VITROS HBSAG CONFIRMATORY ASSAY.
P070006|S002|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT .TB TEST|OJN|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2009|10/22/2009|||OK30|ADDITION OF AN EXTRA APPROVED SUPPLIER OF PEPTIDES.
P070008|S013|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|LEAD FIXATION SLEEVE|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2009|10/28/2009|||APPR|APPROVAL FOR COROX OTW LEAD FIXATION SLEEVE (EFH) MODIFICATIONS.  THE DEVICE IS INDICATED FOR USE ON COROX OTW BP LEADS TO PROVIDE PACING AND/OR SENSING.
P910077|S097|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2009|11/25/2009|||APPR|APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM G2 RF COMMUNICATOR MODEL 6476 SOFTWARE, VERSION 3.02 AND LATITUDE PATIENT MANAGEMENT SERVER MODEL 6488, VERSION 5.2.
P060002|S006|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/30/2009|05/18/2010|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL.
P950039|S020|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSOR 2000/3000|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2009|10/02/2009|||OK30|ADDITION OF IN-HOUSE MANUFACTURING FOR A COMPONENT OF THE DEVICE TO REDUCE MANUFACTURING TIME.
P070006|S003|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT TB TEST|OJN|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/2009|03/04/2010|||APPR|APPROVAL FOR THE INSTITUTION OF THE USE OF SEMI-AUTOMATED SYSTEM FOR THE DISPENSING AND CAPPING STAGES IN THE PRODUCTION OF THE POSITIVE CONTROL, PANEL A REAGENT, AND PANEL B REAGENT OF THE T-SPOT.TB TEST KIT USING THE FF30 DISPENSER/CAPPER FROM FLEXICON.  IN ADDITION, THE TYPE OF VIAL CAPS HAS BEEN CHANGED FROM A POPCAN CAP TO A HDPE CAP WHICH IS NOW GAMMA IRRADIATED RATHER THAN AUTOCLAVED TO REDUCE BACTERIAL AND FUNGAL CONTAMINATION.
P860019|S242|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/2009|12/04/2009|||APPR|VAPPROVAL FOR A CHANGE IN MATERIAL OF THE MARKERBAND TO A PLATINUM/ IRIDIUM ALLOY.
P030031|S019|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/2009|12/07/2009|||APPR|APPROVAL FOR DESIGN MODIFICATIONS REMOVING CARTO RMT CONNECTIVITY FROM THE NAVISTAR RMT THERMOCOOL CATHETER HANDLE, RESULTING IN THE CELSIUS RMT THERMOCOOL CATHETER.
P020026|S070|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2009|06/15/2010|||APPR|APPROVAL FOR AN ALTERNATE TEST METHOD FOR CONDUCTING DRUG UNIFORMITY TESTING.
P990027|S013|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217A EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/2009|11/04/2009|||APPR|APPROVAL FOR SOFTWARE CHANGES INTRODUCED IN SOFTWARE VERSION 4.23A THAT AFFECTED THE ERROR MESSAGE DISPLAYS DURING THE CONDITIONING, ENERGY VERIFICATION, ANDTREATMENT PHASES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETECHNOLAS T217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISION CORRECTION AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR THE REDUCTIONOR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00D AND CYLINDER UP TO -3.00D AND MRSE <=7.50D AT THE SPECTACLE PLANE.
P860004|S114|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2009|10/30/2009|||APPR|APPROVAL FOR CHANGES TO THE IMPLANT MANUALS FOR THE FOLLOWING SUTURELESS CONNECTOR CATHETERS: MODEL 8709SC INDURA 1P ONE-PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT, AND MODEL 8696SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR.
P990034|S014|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2009|10/30/2009|||APPR|APPROVAL FOR CHANGES TO THE IMPLANT MANUALS FOR THE FOLLOWING SUTURELESS CONNECTOR CATHETERS: MODEL 8709SC INDURA 1P ONE-PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR, MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT, AND MODEL 8696SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR.
P950020|S035|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CORONARY FLEXTONE CUTTING BALLOON|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2009|03/18/2010|||APPR|APPROVAL FOR A CHANGE IN A MANUFACTURING INSPECTION PROCESS.
P040024|S044|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2009|11/06/2009|||OK30|CHANGE IN THE QUALITY CONTROL METHOD FOR MICROBIAL CONTAMINATION TESTING.
P890017|S015|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLOON-EXPANDABLE STENT|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2009|10/30/2009|||OK30|DISCONTINUANCE OF A REDUNDANT INSPECTION.
P000046|S016|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|OPTIVISC|LZP|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/02/2009|02/12/2010|||APPR|APPROVAL FOR REVISIONS TO THE LABELING TO REFLECT A NEW DISTRIBUTOR NAME AND TO CHANGE THE TRADE NAME TO OPTIVISC.
P970051|S054|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2009|02/17/2010|||APPR|APPROVAL FOR A CHANGE IN THE ALLOWABLE TOLERANCES OF THE SILICONE OVERMOLD IN THE DISTAL PORTION OF THE RECEIVING COIL FOR THE CI500 SERIES COCHLEAR IMPLANTS.
P960043|S068|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2009|11/03/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE BARREL COMPONENT OF THE DEVICE.
P000032|S029|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|11/04/2009|||OK30|TRANSFERRING PROGRAMMING AND FINAL PLACEMENT OF THE INTEGRATED CHIPS ONTO THE PRINTED CIRCUIT BOARD TO THE SUPPLIER OF THE CHIPS AND PRINTED CIRCUIT BOARD.
P980016|S207|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA/VIRTUOSO II/MAXIMO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|10/30/2009|||OK30|CHANGES TO THE MANUFACTURING SOFTWARE.
P010031|S168|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA/CONCERTO II/MAXIMO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|10/30/2009|||OK30|CHANGES TO THE MANUFACTURING SOFTWARE.
P070007|S013|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/29/2009|11/10/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030054|S137|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS/HF FAMILY OF CRT-DS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|02/03/2010|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.
P030035|S062|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|02/03/2010|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.
P970031|S026|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2009|11/03/2009|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P910023|S221|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|02/03/2010|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.
P880086|S181|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY & ZEPHYR PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|02/03/2010|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.
P880006|S065|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|02/03/2010|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.
P970013|S032|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2009|02/03/2010|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.
P990064|S029|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPRSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2009|11/03/2009|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P980043|S022|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2009|11/03/2009|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P830055|S112|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM ¿ P.F.C. SIGMA RPF FEMORAL COMPONENTS|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2009|12/08/2009|||APPR|APPROVAL FOR ADDITIONAL IN-PROCESS DIMENSIONAL INSPECTIONS OF THE P.F.C. SIGMA RPF FEMORAL COMPONENTS.
P790007|S023|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2009|11/03/2009|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P030017|S096|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2009|11/05/2009|||OK30|MODIFICATION TO THE METHOD FOR ATTACHING CAPACITORS TO THE FLEX CONNECTOR.
P040047|S015|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2009|10/22/2009|||OK30|CHANGE TO THE INCOMING INSPECTION SAMPLING PLAN USED FOR INSPECTION OF COMPONENTS USED IN THE MANUFACTURE OF THE DEVICE.
P050037|S021|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2009|11/05/2009|||OK30|CHANGE IN THE INCOMING INSPECTION PLAN FOR MANUFACTURING RAW MATERIALS AND COMPONENTS.
P050052|S024|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2009|11/05/2009|||OK30|CHANGE IN THE INCOMING INSPECTION PLAN FOR MANUFACTURING RAW MATERIALS AND COMPONENTS.
P040051|S002|STELKAST COMPANY|200 HIDDEN VALLEY ROAD||MCMURRAY|PA|15317||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|STELKAST SURPASS ACETABULAR SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/06/2009|04/22/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P080013|S001|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/06/2009|06/29/2010|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL.
P030053|S008|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/28/2009|08/16/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P990056|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2009|12/03/2009|||APPR|APPROVAL FOR THE INTRODUCTION OF A LARGER TEST KIT WITH 200 DETERMINATIONS INSTEAD OF 100 DETERMINATIONS.
P980035|S145|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700, 800 / 900 IPG FAMILY|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P980035|S146|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2009|01/13/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SWISS MANUFACTURING OPERATIONS IN TOLOCHENAZ, SWITZERLAND TO PERFORM FINAL PACKAGING FOR THE DEVICE.
P060039|S007|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P980016|S208|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA/DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2009|01/13/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SWISS MANUFACTURING OPERATIONS IN TOLOCHENAZ, SWITZERLAND TO PERFORM FINAL PACKAGING FOR THE DEVICE.
P010031|S169|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2009|01/13/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SWISS MANUFACTURING OPERATIONS IN TOLOCHENAZ, SWITZERLAND TO PERFORM FINAL PACKAGING FOR THE DEVICE.
P080006|S003|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LV LEAD|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P930039|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, SUREFIX LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P010015|S073|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P, INSYNC III CRT-P, ATTAIN OTW LEAD, ATTAIN BIPOLAR OTW LEAD, ATTAIN CS LEAD AND ATTAIN LV LEAD|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P010031|S170|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC II MARQUIS ICD|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P830061|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEADS AND CAPSURE SP LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P850089|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z NOVUS LEADS, CAPSURE Z LEADS,  CAPSURE SP LEADS AND CAPSURE SP NOVUS LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P890003|S175|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG AND CAPSURE VDD LEADS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P970012|S058|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR IPG AND KAPPA 400 SR IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P980016|S209|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS IDC FAMILY, MAXIMO ICD FAMILY, INTRINSIC ICD FAMILY, ENTRUST ICD FAMILY|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P990001|S057|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C-SERIES IPG DEVICES, T-SERIES IPG DEVICES DEMA FAMILY|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/08/2009|01/21/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P860057|S060|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2009|11/06/2009|||OK30|SPECIFIC LISTING OF THREE BOVINE PERICARDIAL TISSUE SUPPLIERS.
P970034|S013|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2009|11/13/2009|||OK30|ACQUISITION OF ONE PIECE OF EQUIPMENT AND THE ADDITION OF A TEST FACILITY.
P030031|S020|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR AND CELSIUS THERMOCOOL CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/06/2009|11/24/2009|||APPR|APPROVAL OF THE MODIFIED POST-APPROVAL STUDY PROTOCOL.
P980022|S064|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2009|11/05/2009|||OK30|CHANGE TO REPLACE THE CURRENT DRIVE MOTOR WITH A ROHS COMPLIANT MAXON DRIVE MOTOR.
P990025|S022|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL AND NAVISTAR RMT THERMOCOOL CATHETERS|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/09/2009|12/14/2009|||APPR|APPROVAL FOR CHANGES TO THE CATHETER IFUS TO ALLOW FOR ADDITIONAL COMPATIBILITY WITH THE CARTO 3 SYSTEMS.
P890003|S176|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2009|11/05/2009|||OK30|ADDITION OF A SECOND SUPPLIER MANUFACTURING FACILITY FOR THREE COMPONENTS USED IN MEDTRONIC THERAPY DELIVERY PRODUCTS.
P930039|S034|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2009|11/05/2009|||OK30|ADDITION OF A SECOND SUPPLIER MANUFACTURING FACILITY FOR THREE COMPONENTS USED IN MEDTRONIC THERAPY DELIVERY PRODUCTS.
P010068|S018|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR (4MM, DS, THERMOCOOL AND RMT)|OAD|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/09/2009|12/14/2009|||APPR|APPROVAL FOR CHANGES TO THE CATHETER IFUS TO ALLOW FOR ADDITIONAL COMPATIBILITY WITH THE CARTO 3 SYSTEMS.
P980016|S210|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2009|11/05/2009|||OK30|ADDITION OF A SECOND SUPPLIER MANUFACTURING FACILITY FOR THREE COMPONENTS USED IN MEDTRONIC THERAPY DELIVERY PRODUCTS.
P030031|S021|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER NAV AND EZ STEER NAV DS CATHETERS|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/09/2009|12/14/2009|||APPR|APPROVAL FOR CHANGES TO THE CATHETER IFUS TO ALLOW FOR ADDITIONAL COMPATIBILITY WITH THE CARTO 3 SYSTEMS.
P040036|S014|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR (4MM, DS, THERMOCOOL AND RMT)|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/09/2009|12/14/2009|||APPR|APPROVAL FOR CHANGES TO THE CATHETER IFUS TO ALLOW FOR ADDITIONAL COMPATIBILITY WITH THE CARTO 3 SYSTEMS.
P020014|S029|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|10/13/2009|04/06/2010|||APPR|APPROVAL FOR UPDATED MICRO-INSERT PLACEMENT RATES IN THE PHYSICIAN LABELING RESULTING FROM THE ESS305 POST-APPROVAL STUDY.
P850079|S046|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY TORIC & SPHERE (METHAFILCON A 55%) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2009|01/29/2010|||APPR|APPROVAL FOR THE MIGRATION FROM A MANUAL TO AN AUTOMATIC WET LENS INSPECTION SYSTEM.
P060033|S044|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2009|11/12/2009|||OK30|CHANGE TO THE RELATED SUBSTANCES TEST METHOD.
P030009|S036|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2009|11/12/2009|||OK30|MODIFICATION TO THE E-BEAM STERILIZATION DOSE AUDIT FREQUENCY.
P790017|S101|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2009|11/12/2009|||OK30|MODIFICATION TO THE E-BEAM STERILIZATION DOSE AUDIT FREQUENCY.
P010062|S007|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS|NUU|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2009|02/19/2010|||APPR|APPROVAL OF LABELING CHANGES FOR THE BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS AS A RESULT OF THE POST-APPROVAL STUDY.  THE DEVICE IS INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES.  THE LENSES ARE INDICATED FOR OVERNIGHT WEAR AS PART OF BAUSCH & LOMB VISION SHAPING TREATMENT VST PROCESS FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.50 DIOPTERS.
P040045|S009|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2009|11/10/2009|||OK30|CHANGE IN THE TEST METHOD TO DETERMINE LEACHABLE SUBSTANCES IN VISTAKON (SENOFILCON A) CONTACT LENS MATERIALS.
P990074|S022|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2009|11/10/2009|||OK30|CHANGE IN THE EXPIRATION DATE OF A RAW MATERIAL.
P020056|S011|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2009|11/10/2009|||OK30|CHANGE IN THE EXPIRATION DATE OF A RAW MATERIAL.
P990066|S034|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/13/2009|11/24/2009|||APPR|APPROVAL FOR A MODIFICATION TO THE SENOGRAPHE DS AND SENOGRAPHE ESSENTIAL FFDM SYSTEMS THAT WILL REMOVE BOTH MAGNIFICATION STANDS, AND CORRESPONDING MAGNIFICATION COMPRESSION PADDLES FOR BOTH SYSTEMS.  THE COMPONENTS THAT ARE REMOVED FROM THE CONFIGURATION WILL STILL BE AVAILABLE TO THE CUSTOMER AS OPTIONAL EQUIPMENT.
P840024|S088|Cochlear Americas|400 INVERNESS PARKWAY,|SUITE 400|ENGLEWOOD|CO|80112||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2009|11/12/2009|||APPR|APPROVAL FOR ADDITIONAL LABELING TO RECIPIENTS RECEIVING PRE-PROGRAMMED REPAIRED/REPLACED SOUND PROCESSORS.
P040034|S014|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2009|12/08/2009|||APPR|APPROVAL FOR LABELING CHANGES TO THE DURASEAL ¿INSTRUCTIONS FOR USE¿ INSERT AND AN UPDATE TO THE GRAPHICS FOUND ON THE POLYMER KIT¿S TYVEK LID.
P000015|S011|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2009|11/12/2009|||APPR|APPROVAL FOR ADDITIONAL LABELING TO RECIPIENTS RECEIVING PRE-PROGRAMMED REPAIRED/REPLACED SOUND PROCESSORS.
P970051|S055|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2009|11/12/2009|||APPR|APPROVAL FOR ADDITIONAL LABELING TO RECIPIENTS RECEIVING PRE-PROGRAMMED REPAIRED/REPLACED SOUND PROCESSORS.
P890027|S057|Cochlear Americas|13059 E PEAKVIEW AVE||CENTENNIAL|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 22 COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2009|11/12/2009|||APPR|APPROVAL FOR ADDITIONAL LABELING TO RECIPIENTS RECEIVING PRE-PROGRAMMED REPAIRED/REPLACED SOUND PROCESSORS.
P080013|S002|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/14/2009|12/10/2009|||APPR|APPROVAL TO IDENTIFY ALTERNATE APPLICATORS AND KIT CONFIGURATIONS FOR THE DURASEAL SPINE SEALANT SYSTEM.
P990009|S027|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL ENDOSCOPIC APPLICATOR|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/15/2009|02/02/2010|||APPR|APPROVAL FOR A MANUFACTURING CHANGE TO REMOVE THE ETCHED TERM FLOSEAL FROM THE CANNULA AND SOME LABELING AND INSTRUCTIONS CLARIFICATIONS.
P020026|S071|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2009|03/31/2010|||APPR|APPROVAL FOR THE ADDITION OF A NEW CONTRACTOR FOR QUALITY CONTROL TESTING.
P910077|S098|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 6476 G2 RF LATITUDE COMMUNICATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2009|11/16/2009|||OK30|CHANGE IN THE SOLDERING PROCESS.
P060010|S008|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2009|12/09/2009|||APPR|APPROVAL FOR CHANGES TO THE DESIGN OF THE DISTAL ANCHOR INCLUDING MOLDING THE ANCHOR FLAT, REPLACING THE WIRE REINFORCEMENT WITH AN INCREASE IN DUROMETER OF THE SILICONE, AND ADDING TITANIUM DIOXIDE AS A WHITE COLORANT.
P910023|S222|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2009|11/18/2009|||OK30|CHANGE IN THE SERVICING OF THE DEVICE.
P030054|S138|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2009|11/18/2009|||OK30|CHANGE IN THE SERVICING OF THE DEVICE.
P930014|S036|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2009|11/18/2009|||OK30|ALTERNATE MANUFACTURER/ SUPPLIER OF A DYE.
P040020|S021|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF INTRAOCULAR LENSES|MFK|OP|30-Day Notice||N|10/19/2009|11/18/2009|||OK30|ALTERNATE MANUFACTURER/ SUPPLIER OF A DYE.
P080006|S004|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/19/2009|03/31/2011|||APPR|APPROVAL FOR THE ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD.  THE MODEL 4396 LEAD IS A 4 FRENCH, TRANSVENOUS, STEROID ELUTING, DUAL ELECTRODE, POLYURETHANE INSULATED, SINGLE COIL, STRAIGHT TIP, TINE FIXATION LEAD INTENDED FOR USE IN LEFT HEART CORONARY VEINS.
P860057|S061|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2009|11/25/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P870056|S035|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2009|11/25/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P870077|S032|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2009|11/25/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P000007|S021|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2009|11/25/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P010041|S020|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2009|11/25/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P040023|S014|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/19/2009|04/20/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P070015|S027|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2009|11/16/2009|||OK30|INCREASE IN THE ETHYLENE OXIDE (ETO) STERILIZATION CYCLE DUNNAGE DENSITY.
P040038|S020|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2009|11/16/2009|||OK30|INCREASE IN THE ETHYLENE OXIDE (ETO) STERILIZATION CYCLE DUNNAGE DENSITY.
P050020|S020|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice||N|10/21/2009|11/20/2009|||OK30|
P030050|S007|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/19/2009|04/05/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040044|S020|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2009|11/20/2009|||OK30|MODIFICATION OF AN IN-PROCESS TEST TO EVALUATE MOISTURE CONTENT OF THE SEALANT IN THE MYNX DEVICE.
P960043|S069|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM & PERCLOSE A T 6F SUTURE-MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2009|11/18/2009|||OK30|ADDITION OF AN ALTERNATIVE SUPPLIER OF NEEDLE SHANKS.
P970018|S019|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN INSTRUMENT|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/2009|03/11/2010|||APPR|APPROVAL TO CHANGE THE DESIGN OF THE DITI (DISPOSABLE TIP) CONE OF THE PREPSTAIN INSTRUMENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BD PREPSTAIN¿ SYSTEM (FORMERLY AUTOCYTE®PREP SYSTEM) AND IS INDICATED FOR LIQUID-BASED THIN LAYER CELL PREPARATION PROCESS.  THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDES (FORMERLYAUTOCYTE®PREP SLIDES) THAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGIC PAPSMEARS.  SUREPATH SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER,PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES. SUREPATH PRESERVATIVE FLUID IS AN APPROPRIATE COLLECTION AND TRANSPORTATION MEDIUM FOR GYNECOLOGIC SPECIMENS TESTED WITH BDPROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIA GONORRHOEAE (GC) QX (GCQ)AMPLIFIED DNA ASSAYS.
P910023|S223|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2009|03/03/2010|||APPR|APPROVAL FOR MERLIN@HOME MODEL EX2000 VERSION 4.5 SOFTWARE.
P030054|S139|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2009|03/03/2010|||APPR|APPROVAL FOR MERLIN@HOME MODEL EX2000 VERSION 4.5 SOFTWARE.
P020008|S002|KARL STORZ ENDOSCOPY-AMERICA, INC.|600 CORPORATE POINTE||CULVER CITY|CA|90230|7600|SYSTEM, IMAGING, FLUORESCENCE|KARL STORZ AUTOFLUORESCENCE SYSTEM|MRK|EN|Real-Time Process||N|10/22/2009|12/23/2009|||APPR|APPROVAL FOR REPLACEMENT OF THE KARL STORZ CAMERA CONTROL UNIT (CCU), TRICAM SL (ANALOG PROCESSING) WITH THE TRICAM SL II (DIGITAL SIGNAL PROCESSING).
P010031|S171|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION; MODEL SW009|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/2009|03/25/2011|||APPR|APPROVAL FOR PROTECTA XT CRT-D D314TRG AND PROTECTA CRT-D D334TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG, AND PROTECTA VR D334VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODEL SW009 APPLICATION SOFTWARE V1.0, CARELINK MONITOR MODEL 2490C UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
P980016|S211|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG,  IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/2009|03/25/2011|||APPR|APPROVAL FOR PROTECTA XT CRT-D D314TRG AND PROTECTA CRT-D D334TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG, AND PROTECTA VR D334VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODEL SW009 APPLICATION SOFTWARE V1.0, CARELINK MONITOR MODEL 2490C UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
P890003|S177|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/2009|03/25/2011|||APPR|APPROVAL FOR PROTECTA XT CRT-D D314TRG AND PROTECTA CRT-D D334TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG, AND PROTECTA VR D334VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, MODEL SW009 APPLICATION SOFTWARE V1.0, CARELINK MONITOR MODEL 2490C UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
P040050|S004|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2009|11/16/2009|||OK30|IMPLEMENTATION OF A NEW TEST METHOD FOR MEASURING PARTICLE SIZE DISTRIBUTION.
P020047|S016|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2009|11/24/2009|||OK30|CHANGE TO OPTIMIZE THE VISION STENT LASER CUTTING PROCESS TO REDUCE STENT (STRUT) DIMENSIONAL VARIATION AND IMPROVE OVERALL PROCESS CAPABILITY.
P960013|S053|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2009|11/20/2009|||OK30|ALTERNATE ASSEMBLY SUPPLIER.
P040044|S021|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/23/2009|12/11/2009|||APPR|APPROVAL FOR CHANGES TO THE CATHETER HUB BARREL AND COMPRESSION SPRING LOCATED INSIDE THE MYNX HANDLE.
P040037|S025|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2009|11/20/2009|||OK30|ADDITIONAL PACKAGING EQUIPMENT.
P050006|S015|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2009|11/20/2009|||OK30|ADDITIONAL PACKAGING EQUIPMENT.
P040043|S032|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2009|11/20/2009|||OK30|ADDITIONAL PACKAGING EQUIPMENT.
P020004|S048|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2009|11/20/2009|||OK30|ADDITIONAL PACKAGING EQUIPMENT.
P040027|S018|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2009|11/20/2009|||OK30|ADDITIONAL PACKAGING EQUIPMENT.
P060039|S008|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC ATTAIN STARFIX LEAD MODEL 4195|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/26/2009|12/22/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970051|S057|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2009|05/14/2010|||APPR|APPROVAL FOR A CHANGE TO THE MATERIAL USED IN THE MANUFACTURING OF THE MICROPHONE PROTECTOR COVER FOR THE CP810 SOUND PROCESSOR.
P860004|S115|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||SYNCHROMED INFUSION SYSTEM||HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2009|11/23/2009|||OK30|MANUFACTURING PROCESS AND RAW MATERIAL SPECIFICATION CHANGES FOR THE TUBE COMPONENT OF THE DEVICE.
P040034|S015|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2009|11/25/2009|||OK30|CHANGE TO THE NUMBER OF TRAYS IN THE DEPYROGENATION OVEN AND THE VIAL CAPPING MACHINE.
P040044|S022|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2009|11/25/2009|||OK30|MODIFICATION OF A MANUFACTURING PROCESS TO INCLUDE THE USE OF AN AUTOMATIC TUBING CUTTER.
P910023|S224|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/27/2009|03/03/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE SOFTWARE (VERSION 4.5) USED IN THE MERLIN.NET SYSTEM.
P960016|S025|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|SAFIRE CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2009|11/20/2009|||OK30|CHANGE TO AN AUTOMATED MANUFACTURING PROCESS, A CHANGE IN A WELDING PROCESS AND A CHANGE TO PROCESS MONITORING TESTING.
P970034|S014|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2009|03/12/2010|||APPR|APPROVAL FOR PARAMETER CHANGES IN THE STERILIZATION CYCLE.
P010027|S003|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2009|03/12/2010|||APPR|APPROVAL FOR PARAMETER CHANGES IN THE STERILIZATION CYCLE.
P010030|S013|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process||N|10/29/2009|12/16/2009|||APPR|APPROVAL FOR A MINOR SOFTWARE CHANGE OT THE MODEL WCD 3100 MONITOR.
P040044|S023|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2009|11/25/2009|||OK30|ADDITION OF A HYDROGEL DRYING TIME, A CHANGE IN THE SEQUENCE OF THE APPLICATION OF AN ACCELERATOR, AND A CHANGE IN ADHESIVE (INCLUDING A NEW CURING PROCEDURE).
P960016|S026|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|SAFIRE CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2009|11/25/2009|||OK30|CHANGE IN MANUAL BRAZING PROCESS.
P910023|S225|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|SJM ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2009|11/27/2009|||OK30|ADDITION OF A NEW WASHING PROCESS.
P030054|S140|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SJM CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2009|11/27/2009|||OK30|ADDITION OF A NEW WASHING PROCESS.
P910018|S013|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2009|06/18/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT M.E. NIKKISO CO., LTD, CHACHEONGSAO, THAILAND.
P010030|S014|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2009|11/25/2009|||OK30|REMOVAL OF A TEMPORARY LOW ENERGY CONVERTER TEST.
P010030|S015|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2009|12/16/2009|||APPR|APPROVAL OF AN ALTERNATE FLASH/SRAM CHIP FOR USE ON THE WCD 3100, A CORRECTION OF  A BILL OF MATERIALS ERROR ON THE WCD 3100 COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, AND TWO DESIGN CHANGES TO THE HIGH VOLTAGE CONVERTER CIRCUIT ON THE DEFIBRILLATOR PRINTED CIRCUIT ASSEMBLY.
P080006|S005|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/30/2009|04/29/2011|||APPR|APPROVAL FOR A SHELF LIFE EXTENSION FROM 6 TO 24 MONTHS.
P000057|S005|INTEGRA LIFESCIENCES CORPORATION|8900 CAMERON ROAD||AUSTIN|TX|78754||Finger semi-constrained pyrolytic carbon uncemented prosthesis|ASCENSION MCP|NEG|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/05/2009|12/04/2009|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960016|S027|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|SAFIRE CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2009|11/25/2009|||OK30|ADDITION OF NEW FIXTURES TO THE MANUFACTURING PROCESS TO IMPROVE CONSISTENCY OF APPLYING THE UV ADHESIVE TO THE CATHETER.
P060008|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2009|11/25/2009|||OK30|CHANGES TO UPDATE THE EXTRUSION PROCESS SETTINGS.
P040016|S038|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2009|11/25/2009|||OK30|CHANGES TO UPDATE THE EXTRUSION PROCESS SETTINGS.
P030025|S065|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2009|11/25/2009|||OK30|CHANGES TO UPDATE THE EXTRUSION PROCESS SETTINGS.
P020009|S051|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2009|11/25/2009|||OK30|CHANGES TO UPDATE THE EXTRUSION PROCESS SETTINGS.
P860019|S243|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2009|11/25/2009|||OK30|CHANGES TO UPDATE THE EXTRUSION PROCESS SETTINGS.
P070014|S005|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2009|11/27/2009|||OK30|TRANSFER OF THE ¿HANDLE TRIM¿ PROCESS STEP.
P010030|S016|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2009|07/02/2010|||APPR|APPROVAL FOR HARDWARE CHANGES IN THE DEVICE FOR THE REDUCTION OF HAZARDOUS SUBSTANCES (ROHS) COMPLIANCE.
P000025|S044|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|03/26/2010|||APPR|APPROVAL FOR A MANUFACTURING PROCESS CHANGE AND AN EQUIPMENT CHANGE DESIGNED TO IMPROVE AN EXISTING MANUFACTURING STEP PERFORMED IN MED-EL IMPLANT MANUFACTURING.
P010030|S017|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|12/02/2009|||OK30|ADDITION OF A CONTRACT MANUFACTURER FOR A UNIT SUB-ASSEMBLY.
P010030|S018|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2009|12/17/2009|||APPR|APPROVAL OF A CONSTRUCTION CHANGE AFFECTING THE LAYER STACK UP WITHIN THE RESPONSE BUTTONS.
P050016|S005|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/02/2009|12/03/2009|||APPR|APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND PATIENT BROCHURE TO INCLUDE TWO ADDITIONAL POTENTIAL ADVERSE EFFECTS, PSEUDOTUMOURS AND AVASCULAR LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESIONS (ALVAL) AS WELL AS AN ADDITIONAL PRECAUTION THAT THE SUBJECT DEVICE HAS NOT BEEN TESTED IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT.
P970051|S058|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice||N|11/02/2009|12/02/2009|||OK30|CHANGES TO THE MANUFACTURING PROCESS FOR THE WELDING OF THE INTERNAL MAGNET OF THE CI500 SERIES COCHLEAR IMPLANT.
P930038|S060|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|12/03/2009|||OK30|ALTERNATE VENDOR TO SUPPLY BOVINE COLLAGEN.
P980022|S065|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP (MMT-522, MMT-522K,MMT-722,MMT-722K) & GUARDIAN REAL-TIME MONITOR (CSS7100,CSS7100K)|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|12/01/2009|||OK30|MINOR CHANGE TO THE POWER INDUCTORS USED IN THE PARADIGM REAL-TIME PUMP AND THE GUARDIAN REAL-TIME MONITOR AND REPLACING THE SUPPLIER OF THE POWER INDUCTORS.
P950034|S032|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|11/30/2009|||OK30|CHANGES IN THE MANUFACTURING PROGRAMS.
P040012|S031|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/02/2009|04/30/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE INDICATION STATEMENT AND INSTRUCTIONS FOR USE TO INCORPORATE USE WITH THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM. THE DEVICE, AS MODIFIED, WILLBE MARKETED UNDER THE TRADE NAME RX ACCULINK CAROTID STEM SYSTEM AND IS INDICATED FOR USEIN CONJUNCTION WITH ABBOTT VASCULAR'S ACCUNET OR EMBOSHIELD FAMILY OF EMBOLIC PROTECTIONSYSTEMS, FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA AS PREVIOUSLY APPROVED.
P010007|S004|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 AFP|LOK|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|01/21/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS IN NEWARK, DELAWARE.
P050016|S006|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2009|12/31/2009|||APPR|APPROVAL FOR A CHANGE TO THE METHOD OF STERILIZATION OF THE INDIVIDUALLY PACKAGED FLUTED GUIDE WIRE AND REVISIONS TO THE PACKAGE LABELING.
P930027|S010|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATION PSA|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|01/21/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS IN NEWARK, DELAWARE.
P060005|S003|SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED|GLYN RHONWY. LLANBERIS|CAERNARFON|GWYNEDD, LL55||4EL||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|01/21/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS IN NEWARK, DELAWARE.
P020047|S017|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2009|06/22/2010|||APPR|APPROVAL FOR THE MULTI-LINK 8 AND MULTI-LINK 8 LONG LESION CORONARY STENT SYSTEM.
P010050|S010|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|01/20/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE FOR IMMULITE SUBSTRATE MANUFACTURING.
P010051|S007|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|01/20/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE FOR IMMULITE SUBSTRATE MANUFACTURING.
P010052|S007|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|01/20/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE FOR IMMULITE SUBSTRATE MANUFACTURING.
P010053|S006|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|01/20/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE FOR IMMULITE SUBSTRATE MANUFACTURING.
P880090|S027|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|POLYMETHYMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|12/02/2009|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.
P840039|S059|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|POLYMETHYMETHACRYLATE INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|12/02/2009|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.
P910061|S019|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|12/02/2009|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.
P860047|S023|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2009|12/02/2009|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.
P050007|S023|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2009|01/27/2010|||APPR|APPROVAL TO INCREASE THE CLEARANCE OF THE CLIP DELIVERY TUBE AND MINOR MODIFICATIONS TO THE EXCHANGE SYSTEM AND SHEATH SPLITTER FOR THE DEVICE.
P000029|S060|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2009|11/24/2009|||OK30|CHANGE IN AN INCOMING QUALITY CONTROL TEST METHOD FOR A CHEMICAL ENTITY IN THE GEL AS WELL AS A CHANGE IN THE OFFICIAL COMPANY NAME OF THE SUPPLIER OF THE CHEMICAL ENTITY.
P990037|S029|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|D-STAT FLOWABLE HEMOSTAT|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2009|12/02/2009|||OK30|CHANGES TO STERILIZATION CONFIGURATION AND CAPACITY.
P950029|S048|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|ELA MEDICAL'S REPLY PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2009|06/18/2010|||APPR|APPROVAL FOR SOFTWARE VERSIONS W1.5.2 AND W1.5.3 FOR THE REPLY PACEMAKER.
P950029|S049|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY (V2) AND ESPRIT DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2009|06/18/2010|||APPR|APPROVAL FOR SOFTWARE VERSIONS W2.7.3 AND W2.7.4 FOR THE REPLY (V2) AND ESPRIT PACEMAKERS.
P030025|S066|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|ADDITION OF AN ANALYTICAL TEST METHOD.
P060008|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITTAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|ADDITION OF AN ANALYTICAL TEST METHOD.
P060006|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|ADDITION OF AN ANALYTICAL TEST METHOD.
P040016|S039|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|ADDITION OF AN ANALYTICAL TEST METHOD.
P020009|S052|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|ADDITION OF AN ANALYTICAL TEST METHOD.
P860019|S244|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|ADDITION OF AN ANALYTICAL TEST METHOD.
P030025|S067|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/02/2009|||OK30|CHANGE TO THE FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) METHOD.
P060008|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/02/2009|||OK30|CHANGE TO THE FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) METHOD.
P060006|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/02/2009|||OK30|CHANGE TO THE FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) METHOD.
P040016|S040|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|11/05/2009|12/02/2009|||OK30|CHANGE TO THE FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) METHOD.
P020009|S053|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/02/2009|||OK30|CHANGE TO THE FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) METHOD.
P860019|S245|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/02/2009|||OK30|CHANGE TO THE FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) METHOD.
P030025|S068|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|11/05/2009|12/03/2009|||OK30|UPDATE TO AN ANALYTICAL TEST METHOD.
P060008|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/03/2009|||OK30|UPDATE TO AN ANALYTICAL TEST METHOD.
P030025|S069|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|04/27/2010|||APPR|APPROVAL FOR A CHANGE IN THE STENT COATING PROCESS.
P060008|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice||N|11/05/2009|04/27/2010|||APPR|APPROVAL FOR A CHANGE IN THE STENT COATING PROCESS.
P030025|S070|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|UPDATE TO AN ANALYTICAL TEST METHOD.
P060008|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|UPDATE TO AN ANALYTICAL TEST METHOD.
P060002|S007|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/02/2009|||OK30|CHANGE IN ENVIRONMENTAL MONITORING TESTING.
P980037|S033|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|CHANGE FORM A MANUAL TO AN AUTOMATED FINAL PACKAGING PROCESS.
P010025|S017|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|11/05/2009|12/23/2009|||APPR|APPROVAL FOR THE SELENIA DIMENSION 2D FFDM TO BE USED IN A MOBILEENVIRONMENT WITH THE FOLLOWING DESIGN CHANGES:1) ACQUISITION STATION:A) THE ACQUISITION STATION MONITOR WILL BE MOUNTED ON A FIXED MOUNT MECHANISM THAT ALLOWS POSITIONING OF THE MONITOR VIA A SPRING LOADED LOCKING DEVICE. THE MOBILE SYSTEM MONITOR CAN BE FIXED MOUNTED ON THE LEFT,RIGHT OR CENTER POSITION.B) THE KEYBOARD TRAY HAS BEEN SECURED WITH A SPRING LOADED LATCHING MECHANISM TO PREVENT MOVEMENT DURING TRANSPORT.C) THE BAR CODE SCANNER CAN BE MOUNTED EITHER ON THE LEFT OR RIGHT SIDE OF THE MONITOR AS NEEDED IN THE MOBILE APPLICATION.D) THE X-RAY SHIELD IS REPLACED WITH NON ATTENUATING, COSMETIC CLEAR PLASTIC (AS COVER GAP FILLERS). 2) GANTRY:A) THE VERTICAL TRAVEL ASSEMBLY (VTA) HAS BEEN CONFIGURED WITH AN ELECTROMAGNETICBRAKE TO PREVENT UNWANTED TRAVEL DURING TRANSPORT. B) A MOUNTING FEATURE HAS BEEN ADDED TO THE TOP SECTION OF THE GANTRY FRAME FORSUPPLEMENTAL SUPPORT IN A COACH/VAN.C) THE UPPER MOVEMENT LIMIT OF THE C-ARM IS NOW CONFIGURABLE FROM 6' 10" TO 7' 10" TO ALLOW FOR LOWER CEILINGS IN A COACH/VAN.3) INSTRUCTIONS FOR USE AND QC MANUAL:A MOBILE ADDENDUM INCLUDES CURRENT USER MANUAL WITH ADDED WARNINGS AND INSTRUCTIONSREGARDING MOBILE USE. IN ADDITION, THE MOBILE ADDENDUM INCLUDES INSTRUCTIONS TO THE USER ON THE QC TESTS THAT ARE REQUIRED TO BE PERFORMED PRIOR TO CLINICAL USE AFTER MOVEMENT.
P040001|S016|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS SPACER SYSTEM|NQO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/2009|04/30/2010|||APPR|APPROVAL FOR ADDITIONAL SURGICAL INSTRUMENTS, CHANGES TO EXISTING INSTRUMENTS AND A NEW STERILIZATION TRAY.  THESE NEW COMPONENTS INCLUDE THE SIZING DISTRACTOR, THE SPACER INSERTION INSTRUMENT WITH TRI-LOBE CONNECTORS, THE BI-DIRECTIONAL SIZING DISTRACTOR, THE HORIZONTAL HANDLE, THE TRIAL SPACERS, AND THE TWO-LEVEL STERILIZATION TRAY.
P910023|S226|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FORTIFY DR / VR ICD SYSTEMS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/2009|05/07/2010|||APPR|APPROVAL FOR THE FORTIFY VR/DR PULSE GENERATORS.
P030054|S141|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY CRT-D SYSTEM|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/2009|05/07/2010|||APPR|APPROVAL FOR THE UNIFY CRT-D PULSE GENERATORS.
P050012|S021|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCON SEVEN SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2009|12/04/2009|||OK30|REPLACEMENT OF PAPER-BASED LOT HISTORY RECORDS (LHRS) WITH ELECTRONIC LHRS.  THE CHANGE IMPLEMENTS CAMSTAR MANUFACTURING EXECUTION SYSTEM (MES), AN ELECTRONIC CONTROL SYSTEM FOR MANAGING AND MONITORING WORK-IN PROCESS ON A MANUFACTURING FLOOR.
P020009|S054|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS AND EXPRESS 2 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/02/2009|||OK30|MODIFICATION TO A STEP IN THE STENT FINAL INSPECTION WORK INSTRUCTION.
P030025|S071|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/02/2009|||OK30|MODIFICATION TO A STEP IN THE STENT FINAL INSPECTION WORK INSTRUCTION.
P040016|S041|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/02/2009|||OK30|MODIFICATION TO A STEP IN THE STENT FINAL INSPECTION WORK INSTRUCTION.
P060006|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/02/2009|||OK30|MODIFICATION TO A STEP IN THE STENT FINAL INSPECTION WORK INSTRUCTION.
P060008|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/02/2009|||OK30|MODIFICATION TO A STEP IN THE STENT FINAL INSPECTION WORK INSTRUCTION.
P030025|S072|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/03/2009|||OK30|ALTERNATE METHOD FOR SELECTING THE WIDTH MEASUREMENT PROGRAM SETTINGS.
P020009|S055|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/03/2009|||OK30|ALTERNATE METHOD FOR SELECTING THE WIDTH MEASUREMENT PROGRAM SETTINGS.
P040016|S042|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/03/2009|||OK30|ALTERNATE METHOD FOR SELECTING THE WIDTH MEASUREMENT PROGRAM SETTINGS.
P060008|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/03/2009|||OK30|ALTERNATE METHOD FOR SELECTING THE WIDTH MEASUREMENT PROGRAM SETTINGS.
P030025|S074|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/02/2009|||OK30|ELIMINATION OF DUPLICATE ENVIRONMENTAL TESTING.
P060008|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2009|12/02/2009|||OK30|ELIMINATION OF DUPLICATE ENVIRONMENTAL TESTING.
P860057|S062|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2009|01/05/2010|||APPR|APPROVAL FOR ELIMINATION OF STENT CREEP TESTING FROM THE SHELF LIFE TESTING PROTOCOL FOR THE PERIMOUNT BIOPROSTHETIC VALVES TREATED WITH THE THERMAFIX PROCESS.
P990033|S016|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15 FLOW|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/09/2009|||OK30|CHANGE OF THE IN-PROCESS BIOBURDEN SPECIFICATION.
P040048|S010|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/08/2009|||OK30|CHANGE TO MANUFACTURING STEPS AND MATERIALS USED DURING THE MANUFACTURE OF THE VERSYS HERITAGE FEMORAL STEMS.
P970003|S108|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/2009|04/14/2010|||APPR|APPROVAL FOR LABELING CHANGES FOR END OF SERVICE (EOS) WARNING AND LOW IMPEDANCE WARNING.
P970051|S059|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|08/20/2010|||APPR|APPROVAL TO ADD AN N-HEPTANE WASH OF THE IMPLANT PRIOR TO OVER-MOLDING.
P960013|S054|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL STS LEAD MODEL 1988TC|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/2009|04/14/2010|||APPR|APPROVAL FOR THE TENDRIL STS MODEL 1988TC LEAD.
P030025|S075|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/07/2009|||OK30|ADDITION OF A VACUUM LOADER TO THE MANUFACTURING PROCESS.
P960011|S014|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/16/2009|||OK30|CHANGE IN PRESSURE SET POINTS DURING SODIUM HYALURONATE FERMENTATION.
P010029|S009|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/16/2009|||OK30|CHANGE IN PRESSURE SET POINTS DURING SODIUM HYALURONATE FERMENTATION.
P030025|S076|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/07/2009|||OK30|CHANGE IN THE FREQUENCY OF REPLACEMENT FOR THE ACID BATH.
P030009|S037|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/30/2009|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND.
P040016|S043|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/07/2009|||OK30|CHANGE IN THE FREQUENCY OF REPLACEMENT FOR THE ACID BATH.
P060008|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/07/2009|||OK30|CHANGE IN THE FREQUENCY OF REPLACEMENT FOR THE ACID BATH.
P790017|S102|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2009|12/30/2009|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND.
P000029|S061|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2009|12/10/2009|||OK30|CHANGES TO THE MICROBIOLOGICAL SAMPLING OF THE CLEAN ROOM AND WATER IN THERMAL UNITS.
P860004|S116|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PUMP MODEL 8637|LKK|HO|Special (Immediate Track)||N|11/10/2009|12/04/2009|||APPR|APPROVAL FOR LABELING CHANGES TO THE STERILE PACKAGE, SHELF BOX LABEL AND IMPLANT MANUAL TO REFLECT A NEW WARNING WHICH STATES ¿WARNING: KEEP AWAY FROM MAGNETS.¿
P030025|S077|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2009|12/07/2009|||OK30|MODIFICATION TO A FIXTURE USED IN THE CATHETER MANUFACTURING PROCESS.
P060008|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2009|12/07/2009|||OK30|MODIFICATION TO A FIXTURE USED IN THE CATHETER MANUFACTURING PROCESS.
P040016|S044|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2009|12/07/2009|||OK30|MODIFICATION TO A FIXTURE USED IN THE CATHETER MANUFACTURING PROCESS.
P030025|S078|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (MONORAIL & OVER-THE-WIRE)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2009|08/13/2010|||APPR|APPROVAL FOR A CHANGE TO THE LASER CUTTING SETUP PROCESS.
P020009|S056|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEMS (MONORAIL & OVER-THE-WIRE)|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2009|08/13/2010|||APPR|APPROVAL FOR A CHANGE TO THE LASER CUTTING SETUP PROCESS.
P060006|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2009|08/13/2010|||APPR|APPROVAL FOR A CHANGE TO THE LASER CUTTING SETUP PROCESS.
P880003|S099|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|DURASTAR/FIRESTAR RX PTCA DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2009|12/11/2009|||OK30|MODIFICATION TO THE CATHETER TIP CUTTING OPERATION.
P950020|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON|LOX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2009|12/28/2009|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC IRELAND, LTD., GALWAY, IRELAND.
P070015|S028|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2009|04/01/2010|||APPR|APPROVAL FOR THE IN VIVO IN VITRO CORRELATION (IVIVC) METHOD FOR THE DEVICE.
P990038|S012|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS ASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2009|01/12/2010|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO 8 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE.
P990045|S009|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS ASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2009|01/12/2010|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO 8 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE.
P040033|S014|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2009|12/11/2009|||APPR|APPROVAL FOR REVISIONS TO THE PHYSICIAN AND PATIENT LABELING.
P990044|S009|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS ASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2009|01/12/2010|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO8 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE.
P990040|S010|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2009|12/23/2009|||OK30|ADDING A NEW CONTRACTOR FOR QUALITY CONTROL TESTING AND CHANGE IN THE SUPPLY CHAIN.
P990043|S012|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS ASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2009|01/12/2010|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO 6 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE.
P010013|S026|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2009|01/12/2010|||APPR|APPROVAL FOR THE ADDITION OF SMOOTH ACCESS TIPS TO THE TIPS OF THE NOVASURE DISPOSABLE ARRAY.
P990041|S011|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS ASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2009|01/12/2010|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO 6 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE.
P990041|S012|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS KIT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2009|05/21/2010|||APPR|APPROVAL FOR CHANGING BSA RAW MATERIAL.
P990042|S009|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS KIT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2009|05/21/2010|||APPR|APPROVAL FOR CHANGING BSA RAW MATERIAL.
P990045|S010|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS KIT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2009|05/21/2010|||APPR|APPROVAL FOR CHANGING BSA RAW MATERIAL.
P990044|S010|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-COREK-IGMK PLUS KIT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2009|05/21/2010|||APPR|APPROVAL FOR CHANGING BSA RAW MATERIAL.
P950032|S054|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/13/2009|12/29/2009|||APPR|APPROVAL FOR A NEW CELL STRAIN, HEP 066, FOR INTRODUCTION INTO PRODUCTION OF APLIGRAF.
P990038|S013|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY TEST KIT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2009|05/21/2010|||APPR|APPROVAL FOR CHANGING BSA RAW MATERIAL.
P990043|S013|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS KIT|LOM|MI|135 Review Track For 30-Day Notice||N|11/13/2009|05/21/2010|||APPR|APPROVAL FOR CHANGING BSA RAW MATERIAL.
P990052|S022|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE SYSTEM|MPV|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2009|07/27/2010|||APPR|APPROVAL OF THE AMADÉ AUDIO PROCESSOR AND THE SYMFIT SYSTEM SOFTWARE VERSION 5.0.
P030035|S063|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2009|12/16/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE RF ELECTRONIC ASSEMBLY MODULE.
P880086|S182|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2009|12/16/2009|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE RF ELECTRONIC ASSEMBLY MODULE.
P980049|S051|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR AND OVATIO DR ICDS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2009|12/14/2009|||OK30|CHANGE IN THE LOCATION FOR MANUFACTURING THE HYBRID ELECTRONIC MODULE COMPONENT.
P060027|S016|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ELA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2009|12/14/2009|||OK30|CHANGE IN THE LOCATION FOR MANUFACTURING THE HYBRID ELECTRONIC MODULE COMPONENT.
P960040|S206|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2009|12/14/2009|||OK30|CHANGE TO IN-PROCESS ACCEPTANCE TESTING FOR SPECIFIC COMPONENTS.
P010012|S222|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2009|12/14/2009|||OK30|CHANGE TO IN-PROCESS ACCEPTANCE TESTING FOR SPECIFIC COMPONENTS.
P000006|S017|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/19/2010|07/02/2010|||APPR|APPROVAL FOR A NEW DEVICE PRODUCTION MOLD THAT INCORPORATES A TEAR TRIM AND STRAIN RELIEF FEATURE, AS WELL AS MODIFICATIONS TO ASSOCIATED ENGINEERING DRAWINGS AND DIMENSIONAL TOLERANCE SPECIFICATIONS.
P050047|S010|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2009|12/29/2009|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER.
P980035|S147|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA IPG IMPLANTABLE PULSE GENERATOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2009|03/22/2011|||APPR|APPROVAL FOR NEW APPLICATION SOFTWARE VERSION SW003 (VERSION 7.1); RELIA APPLICATION SOFTWARE VERSION SW010 (VERSION 7.1); AND CARELINK DDMA VERSION K3 DDMA1 2V4.
P890003|S178|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2009|03/22/2011|||APPR|APPROVAL FOR NEW APPLICATION SOFTWARE VERSION SW003 (VERSION 7.1); RELIA APPLICATION SOFTWARE VERSION SW010 (VERSION 7.1); AND CARELINK DDMA VERSION K3 DDMA1 2V4.
P000037|S017|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2009|01/14/2010|||APPR|APPROVAL TO CHANGE THE MATERIAL SPECIFICATIONS FOR THE SEWING CUFF PTFE FABRIC USED IN THE ASSEMBLY OF THE ON-X VALVE.
P010029|S010|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2009|10/25/2010|||APPR|APPROVAL FOR ADDITION OF NEW EQUIPMENT USED IN THE MANUFACTURING PROCESS TO INCREASE FINISHED PRODUCT LOT CAPACITY 3 ¿ 4 FOLD.
P070027|S013|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VACSULAR TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2009|12/17/2009|||OK30|ADDITION OF ALTERNATE ADHESIVE APPLICATION EQUIPMENT AND AN IN-PROCESS VISUAL INSPECTION.
P070007|S014|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2009|12/17/2009|||OK30|ADDITION OF ALTERNATE ADHESIVE APPLICATION EQUIPMENT AND AN IN-PROCESS VISUAL INSPECTION.
P030031|S022|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL NAV CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/2009|07/07/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE CATHETERS TO MAKE THEM COMPATIBLE WITH THE CARTO 3 ELECTROANATOMIC NAVIGATION SYSTEM, AND THE ADDITION OF TWO RING ELECTRODES FOR SHAFT VISUALIZATION ON CARTO 3.
P040036|S015|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL NAV CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/2009|07/07/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE CATHETERS TO MAKE THEM COMPATIBLE WITH THE CARTO 3 ELECTROANATOMIC NAVIGATION SYSTEM, AND THE ADDITION OF TWO RING ELECTRODES FOR SHAFT VISUALIZATION ON CARTO 3.
P960009|S072|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA DEEP BRAIN STIMULATION DEVICES|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2009|12/18/2009|||OK30|ADDITION OF AN ALTERNATE DISTRIBUTION SITE FOR THE DEVICE.
P060002|S008|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVACULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2009|12/15/2009|||OK30|INSTALLATION OF ADDITIONAL MANUFACTURING EQUIPMENT.
P790017|S103|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2009|12/15/2009|||OK30|CHANGE IN BIOLOGICAL INDICATOR STORAGE TIMES.
P060017|S004|JANSSEN DIAGNOSTICS|700 US HIGHWAY RTE 202 SOUTH||RARITAN|NJ|08869||Rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection|GENESEARCH BREAST LYMPH NODE (BLN) ASSAY|OCB|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2009|12/17/2009|||OK30|EXTENSION OF SHELF-LIFE OF PLASMID DNA RAW MATERIAL USED IN THE MANUFACTURE OF THE EXTERNAL POSITIVE AND EXTERNAL NEGATIVE CONTROLS OF THE DEVICE.
P060002|S009|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2009|12/18/2009|||OK30|UPGRADE TO PROCESS EQUIPMENT.
P010012|S223|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN AND CONTAK RENEWAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2009|12/22/2009|||OK30|ADDITION OF A NIKON OPTICAL SYSTEM TO THE PROCESS MONITORING STEP.
P030005|S059|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2009|12/22/2009|||OK30|ADDITION OF A NIKON OPTICAL SYSTEM TO THE PROCESS MONITORING STEP.
P960040|S207|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY AND CONFIENT|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2009|12/22/2009|||OK30|ADDITION OF A NIKON OPTICAL SYSTEM TO THE PROCESS MONITORING STEP.
P070007|S015|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2009|12/15/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P070027|S014|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2009|12/15/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P990020|S038|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2009|12/15/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P070014|S006|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT AND LIFESYENT XL VASCULAR STENT SYSTEMS|NIP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/20/2009|12/08/2009|||APPR|APPROVAL FOR THE PROPOSED CHANGE IN PRODUCT LABELING THAT AFFECTS THE STENT DEPLOYMENT PROCEDURES WITHIN THE INSTRUCTIONS FOR USE.
P970021|S028|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/20/2009|05/13/2010|||APPR|APPROVAL FOR UPDATED PROFESSIONAL LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY REQUIRED AS A CONDITION OF APPROVAL TO SUPPLEMENT 14.
P820060|S024|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT AFP-EIA|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2009|02/26/2010|||APPR|APPROVAL FOR CHANGES IN SOFTWARE THAT AFFECTED PATIENT RESULTS REPORTING FOLLOWING AUTOMATED DILUTION.  THE LOW CONCENTRATION LIMIT FLAG FOR THE 1:101 AUTOMATED DILUTION PROTOCOL WITHIN THE AXSYM AFP ASSAY FILE WAS CHANGED FROM 0 NG/ML ON AXSYM CANCER ASSAY DISK VERSION 6, LN 3D50-06.  THE CHANGE IN QUESTION MANDATES THAT PATIENT RESULTS ARE FLAGGED, FOLLOWING AUTO-DILUTION, WHEN THE CALCULATED VALUES OF THE UNDILUTED SAMPLE FALL BELOW 40.40 NG/ML AND THE MEASURED VALUE OF THE DILUTED SAMPLE FALLS BELOW 0.40 NG/ML.
P950032|S055|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/23/2009|||OK30|ADDITION OF AN ALTERNATE MATERIAL SUPPLIER, HYCLONE (LOGAN, UTAH), FOR BULK MEDIA CONTAINING HUMAN (APO) TRANSFERRIN WHICH IS USED IN THE PRODUCTION BULK MEDIA FOR THE PROCESSING OF APLIGRAF.
P040048|S011|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|01/11/2010|||OK30|ADDITION OF AN ALTERNATE TEST METHOD FOR X-RAY DIFFRACTION DETERMINATION (XRD) OF PHASE CONTENT OF THE PLASMA-SPRAYED HYDROXYAPATITE COATINGS AS WELL AS ADDITION OF TWO NEW CONTRACT TESTING FACILITIES (LAMBDA TECHNOLOGIES IN CINCINNATI, OHIO AND EVANS ANALYTICAL GROUP (EAG) IN ROUND ROCK, TEXAS).
P030011|S006|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/23/2009|||OK30|ADDITION OF A HEAT TREATMENT STEP.
P010012|S224|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY SPIRAL LEAD DEVICE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|ADDITION OF A COMPONENT MANUFACTURER.
P010012|S225|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|CHANGE IN THE LEAD-FRAME PLATING AND CAPACITANCE TOLERANCE.
P960040|S208|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN FAMILY OF ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|CHANGE IN THE LEAD-FRAME PLATING AND CAPACITANCE TOLERANCE.
P980035|S148|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P000032|S030|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|11/23/2009|01/20/2010|||APPR|APPROVAL FOR A CHANGE TO THE REFRIGERANT BLEND USED IN THE GAS MIX COMPRESSOR (GMC) OF THE HER OPTION CONSOLE.
P970012|S059|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR & KAPPA 400 SR IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P980016|S212|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II/MARQUIS/MAXIMO/MAXIMO II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/VIRTUOSO II DR/VR/SECURA DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P990001|S058|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG; C-SERIES IPG; T-SERIES IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P010015|S074|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC & INSYNC III CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P010031|S172|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC MARQUIS/II/III/INSYNC PTOTECT II/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2009|12/22/2009|||OK30|CHANGE TO REMOVE A WASHING PROCESS.
P070015|S029|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2009|12/22/2009|||OK30|CHANGE FOR A PROTECTIVE SHEATH COMPONENT.
P950037|S074|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ACTROS, AXIOS, KAIROS, CYLOS, DROMOS, PHILOS, AND PHILOS II FAMILIES OF PACEMAKER PULSE GENERATORS AND PROGRAMMERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2009|01/22/2010|||APPR|APPROVAL TO IMPLEMENT HARDWARE CHANGES TO THE ICS 3000 IMPLANT CONTROL SYSTEM.
P040048|S012|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2009|12/22/2009|||OK30|CHANGES IN THE CERAMIC PLASMA SPRAY ENVIRONMENTALLY CONTROLLED AREA (ECA).
P040024|S045|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|04/07/2010|||APPR|APPROVAL FOR CHANGES IN MICROBIOLOGICAL AND ENVIRONMENTAL TESTING AT THE MANUFACTURING SITES IN SWEDEN.
P960040|S209|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|12/22/2009|||OK30|ADDITION OF TWO NEW ACCEPTANCE ACTIVITIES TO THE FINAL INSPECTION AT THE SUPPLIER.
P010012|S226|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|12/22/2009|||OK30|ADDITION OF TWO NEW ACCEPTANCE ACTIVITIES TO THE FINAL INSPECTION AT THE SUPPLIER.
P920023|S026|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|AMS UROLUME ENDOPROSTHESIS|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|12/23/2009|||OK30|MODIFICATION OF THE REAR HANDLE MOLDING EQUIPMENT AND A RELATED IN-PROCESS TEST FIXTURE.
P050047|S011|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|12/24/2009|||OK30|REMOVAL OF A RETREATMENT STEP OF A RAW MATERIAL.
P950037|S076|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ACTROS & AXIOS & KAIROS DR/SR/SLR/D/S/BA03 DDDR/CYLOS DR/DR-T/VR/DOMOS DR/SR/SL/PHILOS&PHILOS II DR/DR-T/SR/SLR/D/S/PROT|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/25/2009|01/22/2010|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO VERSION 902.U/1.  THIS SOFTWARE IS USED IN THE ICS 3000 SYSTEM TO PROGRAM AND INTERROGATE ALL OF BIOTRONIK¿S US MARKET RELEASED BRADYCARDIA AND TACHYCARDIA PACEMAKERS.
P070008|S014|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/25/2009|01/22/2010|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO VERSION 902.U/1.  THIS SOFTWARE IS USED IN THE ICS 3000 SYSTEM TO PROGRAM AND INTERROGATE ALL OF BIOTRONIK¿S US MARKET RELEASED BRADYCARDIA AND TACHYCARDIA PACEMAKERS.
P000009|S038|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS & LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/25/2009|01/22/2010|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO VERSION 902.U/1.  THIS SOFTWARE IS USED IN THE ICS 3000 SYSTEM TO PROGRAM AND INTERROGATE ALL OF BIOTRONIK¿S US MARKET RELEASED BRADYCARDIA AND TACHYCARDIA PACEMAKERS.
P050023|S028|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/25/2009|01/22/2010|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO VERSION 902.U/1.  THIS SOFTWARE IS USED IN THE ICS 3000 SYSTEM TO PROGRAM AND INTERROGATE ALL OF BIOTRONIK¿S US MARKET RELEASED BRADYCARDIA AND TACHYCARDIA PACEMAKERS.
P880086|S183|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ADDVENT/AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGONPHOENIX|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|05/11/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
P030035|S064|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II/ANTHEM/AESCULA|NKE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|05/11/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
P960013|S055|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL/TENDRIL ST & STS/OPTISENSE|NVN|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|05/11/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
P960030|S028|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS/ISOFLEX S/P/OPTIM|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|05/11/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
P950022|S067|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA/RIATA ST/RIATA ST OPTIM/DURATA|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|05/11/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
P910023|S227|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CADET/CONTOUR/II/MD/ATLAS II/MD/+/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/EPIC II/+/CONVERT|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|05/11/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
P030054|S142|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE/QUICKFLEX/EPIC HF/+HF/II HF/II +HF/ATLAS HF/ATLAS + HF/ATLAS II HF/ATLAS II + HF/PROMOTE/PROMOTE +|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2009|05/11/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO LLC LOCATED IN ARECIBO, PUERTO RICO.
P030028|S001|OPHTEC BV|6421 CONGRESS AVE,SUITE 112||BOCA RATON|FL|33487||LENS, INTRAOCULAR, PHAKIC|ARTISAN/VERISYSE PHAKIC IOL|MTA|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/25/2009|11/09/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P830055|S113|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2009|12/22/2009|||OK30|PACKAGING MATERIAL CHANGE.
P960043|S070|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE/PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2009|12/22/2009|||OK30|CHANGE TO A REPROCESSING MANUFACTURING STEP.
P980035|S149|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2009|12/22/2009|||OK30|CHANGE IN THE SPECIFICATION LIMITS AND IMPLEMENTATION OF THE RTT VBATT TEST BLOCK.
P960040|S210|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2009|12/22/2009|||OK30|CHANGES TO THE FOLLOWING: 1) DECONTAMINATION STEP; 2) WETBLASTING STEP; AND 3) IN PROCESS MONITOR FOR SPECIFICATIONS.
P010012|S227|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2009|12/22/2009|||OK30|CHANGES TO THE FOLLOWING: 1) DECONTAMINATION STEP; 2) WETBLASTING STEP; AND 3) IN PROCESS MONITOR FOR SPECIFICATIONS.
P010012|S228|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-DS|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/27/2009|12/23/2009|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE A WARNING AGAINST SUB PECTORAL DEVICE IMPLANTATION.
P960040|S211|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICDS|LWP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/27/2009|12/23/2009|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE A WARNING AGAINST SUB PECTORAL DEVICE IMPLANTATION.
P980016|S213|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/VIRTUOSO DR/VR ICD/MAXIMO II DR/VR/VIRTUOSO II VR/DR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2009|12/23/2009|||OK30|IMPLEMENTATION OF RADIO FREQUENCY DEVICE TEST CHANGES ON THE AUTOMATED TEST EQUIPMENT APPLICATION SOFTWARE.
P010031|S173|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO CRT ICD/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2009|12/23/2009|||OK30|IMPLEMENTATION OF RADIO FREQUENCY DEVICE TEST CHANGES ON THE AUTOMATED TEST EQUIPMENT APPLICATION SOFTWARE.
P000014|S020|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK  AND CALIBRATOR|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2009|07/16/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS, INC. IN SOUTH WALES, UNITED KINGDOM.
P030026|S019|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2009|07/16/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS, INC. IN SOUTH WALES, UNITED KINGDOM.
P030024|S012|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2009|07/16/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS, INC. IN SOUTH WALES, UNITED KINGDOM.
P010021|S017|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2009|07/16/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS, INC. IN SOUTH WALES, UNITED KINGDOM.
P000044|S023|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2009|07/16/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS, INC. IN SOUTH WALES, UNITED KINGDOM.
P040023|S015|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2009|06/04/2010|||APPR|APPROVAL FOR A MANUFACTURING PROCESS CHANGE TO THE GRIT BLAST OPERATION FOR THE POROUS COATED SUMMIT HIP FEMORAL PROSTHESIS.
P980016|S214|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2009|12/30/2009|||OK30|CHANGE IN THE MEAN POWER PARAMETER FOR A LASER WELDING MANUFACTURING OPERATION.
P010031|S174|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC II/INSYNC III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO & II/MAXIMO II/CONSULTA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2009|12/30/2009|||OK30|CHANGE IN THE MEAN POWER PARAMETER FOR A LASER WELDING MANUFACTURING OPERATION.
P980016|S215|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2009|12/30/2009|||OK30|CHANGES TO A HYBRID TEST.
P010031|S175|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2009|12/30/2009|||OK30|CHANGES TO A HYBRID TEST.
P980035|S150|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONICS ADAPTA, VERSA, SENSIA AND RELIA IMPLANTABLE PULSE GENERATOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/2009|12/08/2010|||APPR|APPROVAL FOR ADAPTA, VERSA,  SENSIA AND RELIA IMPLANTABLE PULSE GENERATORS.
P020022|S009|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2009|12/23/2009|||OK30|ELIMINATION OF AN IN-PROCESS TEST STEP FOR KIT COMPONENTS USED IN THE DEVICE.
P960009|S073|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION SYSTEMS|MHY|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/03/2009|06/01/2010|||APPR|APPROVAL FOR REVISED LABELING FOR THE DEVICE.  THE CHANGES CONSIST OF ORGANIZATION, EDITORIAL, AND CONTENT REVISIONS, WHICH INCLUDE THE ADDITION OF NEW WARNINGS AND CONTRAINDICATIONS.
P860019|S246|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2009|12/17/2009|||OK30|ADDITION OF A VACUUM LOADER TO THE MANUFACTURING PROCESS.
P040016|S045|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2009|12/17/2009|||OK30|ADDITION OF A VACUUM LOADER TO THE MANUFACTURING PROCESS.
P060008|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2009|12/17/2009|||OK30|ADDITION OF A VACUUM LOADER TO THE MANUFACTURING PROCESS.
P040016|S046|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX LIBERTE MONORAIL & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2009|12/17/2009|||OK30|REDUCTION IN THE ACID WASHING CHANGE OUT FREQUENCY.
P060008|S033|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2009|12/17/2009|||OK30|REDUCTION IN THE ACID WASHING CHANGE OUT FREQUENCY.
P030025|S079|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2009|12/17/2009|||OK30|REDUCTION IN THE ACID WASHING CHANGE OUT FREQUENCY.
P010031|S176|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/2009|01/09/2012|||APPR|APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES.
P020026|S072|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2009|01/06/2010|||OK30|CHANGE FOR THE DISTAL TIP ROUNDING OPERATION.
P980016|S216|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/2009|01/09/2012|||APPR|APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES.
P020026|S073|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT/RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2009|03/18/2010|||APPR|APPROVAL FOR A CHANGE IN ENVIRONMENTAL CONDITIONS FOR THE CRIMP AND PACK PROCESS.
P890003|S179|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE|OSR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/2009|01/09/2012|||APPR|APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES.
P000007|S022|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2009|12/30/2009|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P920015|S055|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/2009|01/09/2012|||APPR|APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES.
P870056|S036|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS PORCINE BIOPROSTHESIS & CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2009|12/30/2009|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P010041|S021|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2009|12/30/2009|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P870077|S033|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2009|12/30/2009|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P860057|S063|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE|DYE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2009|03/25/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AS EDWARDS LIFESCIENCES (SINGAPORE), FOR STERILIZATION AND FINAL PACKAGING PROCESSES.
P980035|S151|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/SENSIA/VERSA/RELIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2009|01/06/2010|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER OF SUBSTRATE.
P960011|S015|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)|LZP|OP|30-Day Notice||N|12/07/2009|01/07/2010|||OK30|CHANGE IN THE LAYOUT OF THE MANUFACTURING FACILITY AND RELOCATION OF THE DISSOLUTION VESSEL AND MICROFILTRATION SYSTEM.
P960011|S016|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BD 1% OVD ( 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2009|01/07/2010|||OK30|CHANGE IN A QUALITY CONTROL TEST METHOD FOR THE FINISHED DEVICE.
P010029|S011|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA ( 1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2009|12/22/2009|||OK30|INTRODUCTION OF AN ADDITIONAL PIECE OF EQUIPMENT FOR TESTING IN-PROCESS CONTROL (IPC) AND FINISHED PRODUCT SAMPLES.
P020016|S004|BIOMET MICROFIXATION, INC.|1520 TRADEPORT DR.||JACKSONVILLE|FL|32218||Joint, temporomandibular, implant|TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM|LZD|DE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/02/2009|01/29/2010|||APPR|APPROVAL FOR CHANGES TO THE PACKAGING MATERIALS OF BOTH THE FOSSA AND THE MANDIBULAR TMJ SYSTEM COMPONENTS, AND EXTENSION OF THE SHELF LIFE OF THESE DEVICES TO 5 YEARS.
P980035|S152|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2009|01/06/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P970012|S060|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2009|01/06/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P980016|S217|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/II DR/VR/SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2009|01/06/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P990001|S059|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2009|01/06/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P010015|S075|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P & INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2009|01/06/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P010031|S177|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC MARQUIS II/III/INSYNC PROTECT II/III/INSYNC SENTRY & MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2009|01/06/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P810046|S232|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER NC CORONARY DILATATION CATHETER|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/09/2009|02/04/2010|||APPR|APPROVAL FOR A LINE EXTENSION FOR A 1.5MM DIAMETER SIZE OF THE VOYAGER NC CORONARY DILATION CATHETER.
P970051|S060|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2009|04/23/2010|||APPR|APPROVAL FOR MODIFICATION OF THE METHODOLOGY USED FOR THE FINAL ELECTRODE TESTING OF TE CI500 SERIES IMPLANT.
P010012|S229|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2009|01/12/2010|||OK30|ADDITIONAL HEADER SUPPLIER.
P020026|S074|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/2009|03/18/2010|||APPR|APPROVAL FOR UPDATED TO THE INSTRUCTIONS FOR USE.
P830055|S114|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2009|02/04/2010|||APPR|APPROVAL FOR AN ADDITIONAL VISUAL INSPECTION OF THE SIGMA CR150 CEMENTED FEMORAL COMPONENTS (SIZES 5 AND 6) AND SIGMA PS CEMENTED FEMORAL COMPONENTS (SIZES 5 AND 6).
P010013|S027|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2009|01/07/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF COMPONENT MATERIAL.
P950009|S011|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT SLIDE PROFILER|MNM|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2009|01/08/2010|||OK30|NEW VENDOR OF A COMPONENT PROGRAMMED TO CONTROL DIFFERENT ASPECTS OF THE IMAGE PROCESSING.
P000041|S009|RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|ONGUARD|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/10/2009|06/10/2010|||APPR|APPROVAL FOR THE ONGUARD 5.1 CADE SOFTWARE.
P040023|S016|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2009|09/02/2010|||APPR|APPROVAL FOR A CHANGE TO AN AUTOMATED CLEANING PROCESS AND COMBINATION OF THAT CLEANING PROCESS WITH THE FINAL POLISH PROCESS ON THE FIRM¿S ROUTERS.
P000032|S031|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2009|01/07/2010|||OK30|CHANGE IN THE FINAL TESTER OF THE DEVICE TO BETTER MONITOR TEST RESULTS AS WELL AS CHANGES IN THE TEST METHODS USED IN THE FINAL TESTER.
P030031|S023|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER FAMILY|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2009|03/03/2011|||APPR|APPROVAL FOR ADDITION OF A LABEL DURING A MANUFACTURING PROCESS STEP.
P040036|S016|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER FAMILY|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2009|03/03/2011|||APPR|APPROVAL FOR ADDITION OF A LABEL DURING A MANUFACTURING PROCESS STEP.
P010012|S230|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)|LWP|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|12/11/2009|09/16/2010|11M-0034|01/25/2011|APPR|APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE FOR THE COGNIS  CRT-D MODELS N118, N119; LIVIANCRT-D MODELS H220, H225, H227 AND H229; AND CONTAK RENEWAL 3 RF HE CRT-D MODELSH210, H215, H217, H219 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) AS FOLLOWS:THESE BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INDICATED FOR PATIENTS WITH HEART FAILURE WHO RECEIVE STABLE OPTIMAL PHARMACOLOGIC THERAPY (OPT) FOR HEART FAILURE AND WHO MEET ANY ONE OF THE FOLLOWING CLASSIFICATIONS:1) MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III-IV) WITH EF <= 35% AND QRS DURATION>= 120 MS; OR2) LEFT BUNDLE BRANCH BLOCK (LBBB) WITH QRS >= 130 MS, EF <= 30%, AND MILD (NYHACLASS II) ISCHEMIC OR NONISCHEMIC HEART FAILURE OR ASYMPTOMATIC (NYHA CLASS I)ISCHEMIC HEART FAILURE.
P060033|S045|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/13/2010|||OK30|CHANGES TO THE BALLOON SUBASSEMBLY MANUFACTURING PROCESSES.
P040044|S024|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/12/2010|||OK30|CHANGE TO MANUFACTURING WORK INSTRUCTIONS.
P860057|S064|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/12/2010|||OK30|ADDITION OF TWO EXISTING MODELS TO THOSE ALREADY APPROVED FOR THE CHANGI, SINGAPORE FACILITY AND TO PERFORM A FINAL ASSEMBLY STEP AT THIS FACILITY IN ADDITION TO THE IRVINE AND HOWR FACILITIES.
P070014|S007|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|12/14/2009|06/11/2010|||APPR|APPROVAL FOR A CHANGE IN LABELING THAT UPDATES THE INSTRUCTIONS FOR USE AND THE PATIENT INFORMATION BROCHURE TO INCLUDE THE MOST RECENT CLINICAL DATA UP TO 2 YEARS.
P040014|S012|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/12/2010|||OK30|ADDITION OF A STEP PRIOR TO BONDING THE TIP.
P040042|S017|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/12/2010|||OK30|ADDITION OF A STEP PRIOR TO BONDING THE TIP.
P060019|S010|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/12/2010|||OK30|ADDITION OF A STEP PRIOR TO BONDING THE TIP.
P840001|S142|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|IMPLANTABLE NEUROSTIMULATORS FOR SPINAL CORD STIMULATION|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/13/2010|||OK30|INCREASING THE BAKE TIME FOR CERAMIC SUBSTRATES PRIOR TO THE SOLDER PREP REFLOW AND ADDING AN ADDITIONAL BAKE AFTER THE CLEAN AND DRY PROCESSING STEP.
P960009|S074|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA THERAPY FOR DBS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/13/2010|||OK30|INCREASING THE BAKE TIME FOR CERAMIC SUBSTRATES PRIOR TO THE SOLDER PREP REFLOW AND ADDING AN ADDITIONAL BAKE AFTER THE CLEAN AND DRY PROCESSING STEP.
P970004|S076|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2009|01/13/2010|||OK30|INCREASING THE BAKE TIME FOR CERAMIC SUBSTRATES PRIOR TO THE SOLDER PREP REFLOW AND ADDING AN ADDITIONAL BAKE AFTER THE CLEAN AND DRY PROCESSING STEP.
P050019|S002|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2009|01/12/2010|||OK30|CHANGE TO THE BATCH RELEASE TESTING.
P060008|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2009|01/29/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., IN COVENTRY, RHODE ISLAND.
P980035|S153|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|XC202 CERAMIC CAPACITOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2009|06/18/2010|||APPR|APPROVAL FOR THE MANUFACTURING AND DESIGN CHANGE TO XC202 CERAMIC CAPACITOR OF THE DEVICES.
P920015|S056|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS LEAD SYSTEM, TRANSVENE SVC LEAD|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|05/13/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CENTER VILLALBA IN VILLALBA, PUERTO RICO.
P830060|S064|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BIFURCATED BIPOLAR ENDOCARDIAL TINED LEAD/BIPOLAR ENDOCARDIAL LEAD/POSITIVE FIXATION PROTECTED HELIX BIPOLAR ENDOCARDIAL|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P980050|S043|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|05/13/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CENTER VILLALBA IN VILLALBA, PUERTO RICO.
P890061|S017|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SUPERIOR VENA CAVA LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P910077|S100|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK SQ PATCH LEAD/SQ ARRAY LEAD/SQ ARRAY XP/SMALL & LARGE PATCH LEADVENTAK NINI III/IV/  AICD PULSE GENERATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P910073|S081|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE/S/ENDOTAK ENDURANCE EZ/ENDOTAK RELIANCE SG/G|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P950001|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE PICOTIP BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/SELUTE BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/ATRAIL J SELUTE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P960006|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET PICOTIP RX/FLEXTEND/SWEET TIP RX/FIXATION TOOL|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P940008|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD CAP ACCESSORY KIT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P960040|S212|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM VR/DR AICD PULSE GENERATOR/DR/HE/VITALITY VR AICD PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P030005|S060|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P010012|S231|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P930035|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|#2 BI-DIRETIONAL TORQUE WRENCH|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P960004|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE II STEROX/THINLINE II STEROX/EZ/FINELINE II STEROX/EZ/TAPERED STYLET|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P050046|S005|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2009|01/12/2010|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.
P020004|S049|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2009|05/05/2010|||APPR|APPROVAL FOR AN EXPANSION OF THE MANUFACTURING ENVIRONMENT.
P000007|S023|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2009|01/14/2010|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P870056|S037|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS PORCINE BIOPROSTHESIS/CARPENTIER EDWARDS BIOPROSTHETIC VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2009|01/14/2010|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P000025|S045|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/2009|07/26/2010|||APPR|APPROVAL FOR THE USE OF TWO ALTERNATE HOUSING COMPONENTS AND A MODIFIED IMPACT PROTECTOR COMPONENT FOR USE IN THE MANUFACTURE OF THE SONATATI100 COCHLEAR IMPLANT.
P010041|S022|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2009|01/14/2010|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P870077|S034|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2009|01/14/2010|||OK30|ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
P960011|S017|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|06/15/2010|||APPR|APPROVAL FOR A CHANGE IN MANUFACTURE USING NEW EQUIPMENT.
P020026|S075|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/14/2010|||OK30|CHANGE IN THE STERILIZATION PROCESS FOR THE DEVICE.
P980035|S154|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/SENSIA/VERSA/RELIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF A NEW WELD SYSTEM.
P970012|S061|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF A NEW WELD SYSTEM.
P890003|S180|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF A NEW WELD SYSTEM.
P910077|S101|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK/PRX/VENTAK MINI I-IV|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P010012|S232|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P960006|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX/FLEXTEND|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P910073|S082|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P950001|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P960004|S045|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE/FINELINE|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P050046|S006|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P830060|S065|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P890061|S018|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P930035|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P940008|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q/RES-Q MICRON|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2009|01/15/2010|||OK30|ADDITION OF STERILIZATION HOOP RACKS.
P000006|S018|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2009|01/15/2010|||OK30|MODIFICATION OF THE RESERVOIR DIP COATING PROCESS USING A NEW PIECE OF EQUIPMENT.
P970004|S077|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION (SNS) THERAPY|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2010|03/03/2010|||APPR|APPROVAL FOR THE REFORMULATION OF THE HOTMELT ADHESIVE USED FOR MEDTRONIC NEUROMODULATION STERILE BARRIER BLISTER PACKAGES.
P860004|S117|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PUMP AND INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2010|03/04/2010|||APPR|APPROVAL FOR THE REFORMULATION OF THE HOTMELT ADHESIVE USED FOR MEDTRONIC NEUROMODULATION STERILE BARRIER BLISTER PACKAGES.
P840001|S143|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION THERAPY|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2010|03/04/2010|||APPR|APPROVAL FOR THE REFORMULATION OF THE HOTMELT ADHESIVE USED FOR THE MEDTRONIC NEUROMODULATION STERILE BARRIER BLISTER PACKAGES.
P990034|S015|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED PUMP AND INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2010|03/04/2010|||APPR|APPROVAL FOR THE REFORMULATION OF THE HOTMELT ADHESIVE USED FOR MEDTRONIC NEUROMODULATION STERILE BARRIER BLISTER PACKAGES.
P960009|S075|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION THERAPY|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2010|03/04/2010|||APPR|APPROVAL FOR THE REFORMULATION OF THE HOTMELT ADHESIVE USED FOR THE MEDTRONIC NEUROMODULATION STERILE BARRIER BLISTER PACKAGES.
P000029|S062|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2009|02/23/2010|||OK30|CHANGE TO THE PROCESS USED FOR FASTENING THE NEEDLE TO THE LUER-LOCK HUB.
P070009|S007|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT|LTI|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2009|08/10/2010|||APPR|APPROVAL FOR CONVERTING A MANUAL TO AN AUTOMATED PIN ORIENTING AND FEEDING ASSEMBLY PROCESS.
P880003|S100|CORDIS CORP.|14201 N.W. 60TH AVE.||MIAMI LAKES|FL|33014|5700|Catheters, transluminal coronary angioplasty, percutaneous|PTCA DILATATION  & FIRE STAR RX PTCA BALLOON DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2009|01/20/2010|||OK30|ALTERNATE MANUFACTURING FACILITY FOR AN EXTRUSION PROCESS.
P050020|S021|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2009|01/11/2010|||APPR|APPROVAL FOR LABELING CHANGES FOR THE FREESTYLE NAVIGATOR USER¿S GUIDE AS FOLLOWS: 1) ADDITION OF THE STATEMENT UNDER THE ¿SPECIFICATIONS¿ SECTION¿ ¿STORE THE TEST STRIPS BETWEEN 40 DEGREES F AND 86 DEGREES F.¿; 2) ADDITION OF THE STATEMENT UNDER THE ¿IMPORTANT NOTES¿ SECTION: ¿THE SYSTEM IS INTENDED FOR YOUR PERSONAL USE; DO NOT SHARE YOUR SYSTEM WITH OTHERS.¿
P010054|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS TEST SYSTEM|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2009|01/07/2010|||APPR|APPROVAL FOR THE EXTENSION OF THE ANTI-HBS CALCHECK SHELF-LIFE FROM NINE MONTHS TO FOURTEEN MONTHS WHEN STORED AT 2-8 DEGREES C.
P960040|S213|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2010|03/12/2010|||APPR|APPROVAL FOR THE SECOND SUPPLIER WITH A DESIGN CHANGE FOR THE CAPACITORS USED IN THE COGNIS/TELIGEN FAMILY OF DEVICES.
P010012|S233|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2010|03/12/2010|||APPR|APPROVAL FOR THE SECOND SUPPLIER WITH A DESIGN CHANGE FOR THE CAPACITORS USED IN THE COGNIS/TELIGEN FAMILY OF DEVICES.
P060030|S006|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS TAQMAN HCV TEST VERSION 2.0|MZP|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2009|09/01/2010|||APPR|APPROVAL FOR A MANUAL SPECIMEN PREPARATION OPTION TO THE CURRENTLY APPROVEDAUTOMATED SAMPLE PREPARATION METHOD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND IS INDICATEDFOR:THE COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM IS AN IN VITRONUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA OR SERUM OF HCV-INFECTED INDIVIDUALS USING THE HIGH PURE SYSTEM VIRAL NUCLEIC ACIDKIT FOR MANUAL SPECIMEN PREPARATION AND THE COBAS05 TAQMAN 48 ANALYZER FOR AUTOMATEDAMPLIFICATION AND DETECTION. SPECIMENS CONTAINING HCV GENOTYPES 1 THROUGH 6 HAVE BEENVALIDATED FOR QUANTITATION IN THE ASSAY.THE COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED INDIVIDUALS UNDERGOING ANTI-VIRAL THERAPY. THEASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND CAN BE USED TO PREDICTSUSTAINED AND NON-SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY. THE RESULTS FROM THE COBASTAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITHPEGINTERFERON ALFA-2A PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAY'S PREDICTIVE VALUE WHEN OTHER THERAPIES ARE USED. ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED.
P910001|S034|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVS-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|01/10/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO.
P010031|S178|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC PROTECTA XT CRT-D D314TRM AND PROTECTA CRT-D D334 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2009|11/09/2011|||APPR|APPROVAL FOR THE PROTECTA XT CRT-D, D314TRM AND PROTECTA CRT-DD334TRM IMPLANTABLE CARDIOVERTCR DEFIBRILLATORS WITH CARDIAC RCSYNCHRONIZATION, PROTECTA XT DR D314DRM AND PROTECTA DR D334DRM IMPLANTABLE CARDIOVERTER DEFIBRILLAIORS, MODEL SW009 APPLICATION SOFTWARE VL.0, CARELINK MONITOR MODEL 2490C UPGRADE. CARDIOSIGHT READER MODEL 2020A UPGRADE AND MODEL 2491 DDMA UPGRADE.
P980016|S218|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PROTECTA XT DR D314DRM, PROTECTA DR D334DRM, CARDIOVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2009|11/09/2011|||APPR|APPROVAL FOR THE PROTECTA XT CRT-D, D314TRM AND PROTECTA CRT-DD334TRM IMPLANTABLE CARDIOVERTCR DEFIBRILLATORS WITH CARDIAC RCSYNCHRONIZATION, PROTECTA XT DR D314DRM AND PROTECTA DR D334DRM IMPLANTABLE CARDIOVERTER DEFIBRILLAIORS, MODEL SW009 APPLICATION SOFTWARE VL.0, CARELINK MONITOR MODEL 2490C UPGRADE. CARDIOSIGHT READER MODEL 2020A UPGRADE AND MODEL 2491 DDMA UPGRADE.
P890003|S181|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER|OSR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2009|11/09/2011|||APPR|APPROVAL FOR THE PROTECTA XT CRT-D, D314TRM AND PROTECTA CRT-DD334TRM IMPLANTABLE CARDIOVERTCR DEFIBRILLATORS WITH CARDIAC RCSYNCHRONIZATION, PROTECTA XT DR D314DRM AND PROTECTA DR D334DRM IMPLANTABLE CARDIOVERTER DEFIBRILLAIORS, MODEL SW009 APPLICATION SOFTWARE VL.0, CARELINK MONITOR MODEL 2490C UPGRADE. CARDIOSIGHT READER MODEL 2020A UPGRADE AND MODEL 2491 DDMA UPGRADE.
P070014|S008|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2009|06/09/2010|||APPR|APPROVAL FOR MOVING A MANUFACTURING PROCESS AND ASSOCIATED EQUIPMENT FROM A SUPPLIER TO INTERNAL MANUFACTURING AT BARD ANGIOMED GMBH & CO. MEDIZINTCHNIK KG (ANGIOMED) FOR THE DELIVERY SYSTEM TIP CHAMFERING MANUFACTURING.
P970051|S062|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2009|07/22/2010|||APPR|APPROVAL FOR CHANGES TO COMPONENTS OF THE TRANSMITTING COIL FOR THE CP810 SOUND PROCESSOR.
P840001|S144|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREPRIME & PRIMEADVANCED IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2009|01/21/2010|||OK30|INCREASE IN THE PRESS FORCE USED TO FORM THE BATTERY CATHODES WHICH WILL REDUCE THE CATHODE THICKNESS VARIATION AND INCREASE THE YIELD OF THE RX1 BATTERY PRODUCTION.
P960009|S076|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC IMPLANTABLE NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2009|01/21/2010|||OK30|INCREASE IN THE PRESS FORCE USED TO FORM THE BATTERY CATHODES WHICH WILL REDUCE THE CATHODE THICKNESS VARIATION AND INCREASE THE YIELD OF THE RX1 BATTERY PRODUCTION.
P020026|S077|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/21/2010|||OK30|ADDITIONAL TESTING SITE FOR RAW MATERIAL TESTING.
P060033|S046|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|06/11/2010|||APPR|APPROVAL FOR A CHANGE TO REMOVE THE FUNCTIONAL TEST FROM THE QUALITY RELEASE SPECIFICATION.
P790017|S104|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|06/04/2010|||APPR|APPROVAL FOR A CHANGE TO THE BALLOON SUBASSEMBLY MANUFACTURING PROCESS.
P030009|S038|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRODRIVER CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|06/04/2010|||APPR|APPROVAL FOR A CHANGE TO THE BALLOON SUBASSEMBLY MANUFACTURING PROCESS.
P000010|S015|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|04/08/2010|||OK30|ROOM CHANGES FOR THE MANUFACTURE OF QUANTITATION STANDARD AND INTERNAL CONTROL REAGENTS.
P060033|S047|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|06/04/2010|||APPR|APPROVAL FOR A CHANGE TO THE BALLOON SUBASSEMBLY MANUFACTURING PROCESS.
P030025|S080|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|06/11/2010|||APPR|APPROVAL FOR A CHANGE FROM A MANUAL TO AN AUTOMATED COATING PROCESS.
P000012|S022|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|04/08/2010|||OK30|ROOM CHANGES FOR THE MANUFACTURE OF QUANTITATION STANDARD AND INTERNAL CONTROL REAGENTS.
P060008|S035|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|06/11/2010|||APPR|APPROVAL FOR A CHANGE FROM A MANUAL TO AN AUTOMATED COATING PROCESS.
P040016|S047|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|06/11/2010|||APPR|APPROVAL FOR A CHANGE FROM A MANUAL TO AN AUTOMATED COATING PROCESS.
P060030|S007|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|04/08/2010|||OK30|ROOM CHANGES FOR THE MANUFACTURE OF QUANTITATION STANDARD AND INTERNAL CONTROL REAGENTS.
P050028|S006|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS TAQMAN HBV TEST||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|04/08/2010|||OK30|ROOM CHANGES FOR THE MANUFACTURE OF QUANTITATION STANDARD AND INTERNAL CONTROL REAGENTS.
P930014|S037|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE BAR-SEALER MONITORING SYSTEM.
P040020|S022|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF INTRAOCULAR LENSES (IOLS)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE BAR-SEALER MONITORING SYSTEM.
P880087|S014|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE BAR-SEALER MONITORING SYSTEM.
P840060|S032|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE BAR-SEALER MONITORING SYSTEM.
P810032|S055|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE BAR-SEALER MONITORING SYSTEM.
P880086|S184|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGON/PHOENIX PACEMAKERS/CRT-PS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
P030035|S065|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II/ANTHEM/AESCULA PACEMAKERS/CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
P960013|S056|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL/TENDRIL ST/TENDRIL STS/OPTISENSE LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
P960030|S029|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS/ISOFLEX S & P/ISOFLEX OPTIM LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
P950022|S068|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|RIATA/RIATA ST/RIATA ST OPTIM/DURATA LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
P030054|S143|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE/QUICKFLEX LEADS/EPIC HF/+HF/EPIC II HF/II + HF/ATLAS HF/+ HF/II HF/II + HF/PROMOTE/PROMOTE + ICDS/CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
P910023|S228|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CADET/CONTOUR/CONTOUR II/MD/ATLAS II/MD/PROFILE II/MD/PHOTON/PHOTON MICRO/CURRENT/+/ATLAS II/+/EPIC II/+/CONVERT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2009|01/22/2010|||OK30|CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
P010030|S019|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/28/2009|05/21/2010|||APPR|APPROVAL FOR A COMPONENT VALUE CHANGE TO THE ECG ELECTRODE BUFFER BOARDS TO IMPROVE ECG AMPLIFIER COMMON MODE REJECTION.
P010014|S026|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENSICAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/29/2009|03/29/2010|||APPR|APPROVAL FOR THE ADDITION OF THE OXFORD PARTIAL KNEE TWIN PEG FEMORALS WHICH INCORPORATE ROUNDED ANTERIOR CORNERS IN COMPARISON TO THE OXFORD KNEE FEMORAL COMPONENT WITH 2 PEGS.
P850079|S047|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|12/28/2009|05/03/2010|||APPR|APPROVAL FOR THE TRADE NAME CLEAR SOFT. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME CLEAR SOFT AND IS INDICATED FOR:CLEAR SOFT SPHERE (METHAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA OR HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BYPERSONS WHO EXHIBIT ASTIGMATISM OF -2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.CLEAR SOFT TORIC (METHAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTIONOF AMETROPIA (MYOPIA OR HYPEROPIA WITH ASTIGMATISM) IN APHAKIC AND NON-APHAKIC PERSONSWITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS AND ASTIGMATICCORRECTIONS FROM -0.25 TO -5.00 DIOPTERS.THE CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES HAVE BEEN APPROVED FOR EXTENDED WEAR FOR UP TO 6 NIGHTS/7 DAYS OF CONTINUOUS WEAR. IT ISRECOMMENDED THAT THE CONTACT LENS WEARER FIRST BE EVALUATED ON A DAILY WEAR SCHEDULE. IFSUCCESSFUL, THEN A GRADUAL INTRODUCTION OF EXTENDED WEAR CAN BE FOLLOWED AS DETERMINED BY THE PRESCRIBING EYE CARE PRACTITIONER.EYE CARE PRACTITIONERS MAY PRESCRIBE THE LENS FOR FREQUENT REPLACEMENT WEAR WITH CLEANING, DISINFECTING AND SCHEDULED REPLACEMENTS.
P050012|S022|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2009|01/28/2010|||OK30|CHANGE TO EIGHT-CHANNEL CALCHECK QUALITY CONTROL TOOL.
P980035|S155|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC AT500 DDDRP PACING SYSTEM|NVZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/30/2009|03/31/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980050|S044|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC AT500 DDDRP PACING SYSTEM|LWS|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/30/2009|03/31/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020009|S057|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2009|01/29/2010|||OK30|CHANGE IN A MANUFACTURING INSPECTION PROCEDURE.
P030025|S081|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2009|01/29/2010|||OK30|CHANGE IN A MANUFACTURING INSPECTION PROCEDURE.
P040016|S048|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2009|01/29/2010|||OK30|CHANGE IN A MANUFACTURING INSPECTION PROCEDURE.
P060008|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2009|01/29/2010|||OK30|CHANGE IN A MANUFACTURING INSPECTION PROCEDURE.
P980018|S007|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2009|01/21/2010|||OK30|CHANGES IN THE CONTROL SLIDES FOR THE HERCEPTEST¿ KIT.
P000037|S018|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X ASCENDING AORTIC PROSTHESIS|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2010|01/14/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT VASCUTEK, LTD., SCOTLAND, GREAT BRITAIN (UK).  ALSO APPROVAL FOR A VALVED CONDUIT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER HE TRADE NAME ON-X ASCENDING AORTIC PROSTHESIS AND IS INDICATED FOR THE REPLACEMENT OF A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVE IN THE AORTIC POSITION IN CASES THAT INVOLVE AN ASCENDING AORTIC ANEURYSM OR OTHER ASSOCIATED AORTIC DISEASE.
P850064|S018|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR, MODELS 203 AND 203A|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2010|08/20/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE VENTILATOR SOFTWARE.
P050044|S012|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/04/2010|07/23/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHOVITA, INC. IN MALVERN, PENNSYLVANIA.
P980022|S067|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2010|08/29/2011|||APPR|APPROVAL FOR A CHANGE IN THE RAW MATERIAL USED IN THE ADHESIVE PATCH OF THE GLUCOSE SENSOR COMPONENT (MODELS MMT-7002 AND MMT-7003) OF THE DEVICE.
P970031|S027|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|03/15/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P990064|S030|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|03/15/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P980043|S023|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|03/15/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P790007|S024|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|03/15/2010|||APPR|APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P860004|S118|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMEDPUMP AND INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2010|03/05/2010|||APPR|APPROVAL FOR UPDATING THE ¿DURING DISCHARGE¿ BATTERY SPECIFICATION FOR THE MEDTRONIC SYNCHROMED II DRUG PUMP MODEL 8637.
P950029|S050|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY & RHAPSODY SR/REPLY SR/DR/REPLY SR/DR (V2)/ESPRIT SR/DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|02/05/2010|||OK30|CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING.
P060027|S017|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|02/05/2010|||OK30|CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING.
P970031|S028|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|02/05/2010|||OK30|CHANGE IN THE SUPPLIER LOCATION FOR PARKER SEALS, AN APPROVED COMPONENT SUPPLIER.
P990064|S031|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|02/05/2010|||OK30|CHANGE IN THE SUPPLIER LOCATION FOR PARKER SEALS, AN APPROVED COMPONENT SUPPLIER.
P980043|S024|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|02/05/2010|||OK30|CHANGE IN THE SUPPLIER LOCATION FOR PARKER SEALS, AN APPROVED COMPONENT SUPPLIER.
P870078|S007|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK STANDARD PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2010|02/05/2010|||OK30|CHANGE IN THE SUPPLIER LOCATION FOR PARKER SEALS, AN APPROVED COMPONENT SUPPLIER.
P000020|S013|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/07/2010|01/21/2010|||APPR|APPROVAL FOR THE ADDITION OF A WARNING TO THE INSTRUCTIONS FOR USE STATING: ¿REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT.¿
N12159|S025|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL ORGINAL/SURGICEL FIBRILLAR/SURGICEL NU-KNIT ABSORABLE HEMOSTATS|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2010|02/04/2010|||OK30|TRANSFER OF ONE PROCESS IN THE MANUFACTURE OF A COMPONENT OF THE SURGICEL HEMOSTATS TO THE CURRENT CONTRACT SUPPLIER.
P040001|S017|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS SPACER SYSTEM|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/07/2010|06/02/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060030|S008|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2010|02/04/2010|||OK30|ELIMINATION OF IN-PROCESS CHEMICAL TESTING OF THE BUFFER CONCENTRATE USED TO PREPARE THE MASTER MIX COMPONENT OF THE DEVICE.
P050028|S007|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2010|02/04/2010|||OK30|ELIMINATION OF IN-PROCESS CHEMICAL TESTING OF A BUFFER CONCENTRATE USED TO PREPARE THE MASTER MIX COMPONENT OF THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM.
P040034|S016|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|01/08/2010|05/28/2010|||APPR|APPROVAL TO UPDATE THE CONTENTS OF THE DURASEAL PACKAGE INSERT BASED ON THE RESULTS OF THE POST-APPROVAL STUDY.
P040004|S007|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2010|01/29/2010|||OK30|ALTERNATE SUPPLIER FOR A RAW MATERIAL USED IN A KIT COMPONENT USED IN THE DEVICE.
P010031|S179|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2010|02/05/2010|||OK30|CHANGE TO THE PULSE OF LASER WELD FOR THE FEEDTHROUGH TERMINALS.
P980016|S219|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2010|02/05/2010|||OK30|CHANGE TO THE PULSE OF LASER WELD FOR THE FEEDTHROUGH TERMINALS.
P040033|S015|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/11/2010|03/09/2010|||APPR|APPROVAL FOR THE ADDITION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND AN UPDATE TO THE SURGICAL TECHNIQUE TO REFLECT THE NEW SURGICAL INSTRUMENTS.
P020026|S078|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2010|09/02/2010|||APPR|APPROVAL FOR A CHANGE IN SAMPLING PLAN FROM LOT-TO-LOT TO A SKIP-LOT TESTING PLAN.
P030010|S006|SIEMENS MEDICAL SOLUTION|51 VALLEY STREAM PKWY.||MALVERN|PA|19355||Full field digital,system,x-ray,mammographic|SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/13/2009|11/05/2010|||APPR|APPROVAL FOR CHANGING THE OEM COMPONENTS (DETECTOR AND IMAGE PROCESSING) DEVELOPED BY LORAD, THE MAMMOMAT NOVATION, TO AN FFDM SYSTEM THAT IS DESIGNED SOLELY FROM COMPONENTS DESIGNED OR SPECIFIED BY SIEMENS, THE MAMMOMAT INSPIRATION.
P860057|S065|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX AND MODELS 7200TFX|DYE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/12/2010|03/05/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970004|S078|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2010|02/12/2010|||OK30|CHANGES IN THE COMPONENT INSPECTION PROCEDURES FOR THE DEVICE.
P840001|S145|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL III IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2010|02/12/2010|||OK30|CHANGES IN THE COMPONENT INSPECTION PROCEDURES FOR THE DEVICE.
P060008|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/12/2010|07/22/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060008|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/12/2010|07/22/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040043|S033|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/13/2010|05/25/2010|||APPR|APPROVAL FOR A NEW 22 MM CONSTRAINING SLEEVE SIZE TO BE USED IN THE 40 MM DIAMETER TAG DEVICE.
P040043|S034|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/12/2010|||OK30|ADDITION OF A NEW DEPLOYMENT LINE MATERIAL.
P860019|S247|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK OVER-THE WIRE PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/01/2010|||OK30|CHANGE IN MANUFACTURING PROCESS FLOW FOR BALLOON FORM AND FOLD AND SILICONE COATING.
P030006|S023|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/12/2010|||OK30|APPROVAL FOR CHANGES TO SHELF BOX LABEL, STERILE USE OF A NEW ELECTRICAL SAFETY TEST ON PROLIEVE CONSOLES.
P010031|S180|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC ICD/MARQUIS/II MARQUIS/III MARQUIS/II PROTECT/III PROTECT/SENTRY/MAXIMOICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/18/2010|||OK30|UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
P890003|S182|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/THERA I IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/18/2010|||OK30|UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
P970012|S062|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/18/2010|||OK30|UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
P980016|S220|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/18/2010|||OK30|UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
P980035|S156|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/18/2010|||OK30|UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
P990001|S060|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C-SERIES IPG/T-SERIES IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/18/2010|||OK30|UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
P010015|S076|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P/INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2010|02/18/2010|||OK30|UPDATED VERSION OF THE SOFTWARE FOR THE FEEDTHROUGH LASER WELDER.
P030031|S024|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL CATHETER|LPB|CV|135 Review Track For 30-Day Notice||N|01/14/2010|06/28/2010|||APPR|APPROVAL FOR A TEST METHOD CHANGE FOR THE FINAL INSPECTION FLOW AND LEAK TEST.
P040036|S017|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT THERMOCOOL CATHETER|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2010|06/28/2010|||APPR|APPROVAL FOR A TEST METHOD CHANGE FOR THE FINAL INSPECTION FLOW AND LEAK TEST.
P990066|S035|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/2010|05/20/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE AMORPHOUS SILICON ARRAY DESIGN USED IN THE DETECTOR OF THE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.  THE PROPOSED MODIFICATIONS INCLUDE THE FOLLOWING: 1) REDUCING THE NUMBER OF LAYERS IN THE DETECTOR AMORPHOUS SILICON ARRAY; 2) CHANGE IN THE DETECTOR FIRMWARE TO ALLOW THE DETECTOR CONFIGURATION TO BE COMMUNICATED TO THE SYSTEM IMAGE DETECTOR CONTROLLER (IDC); 3) IDC SOFTWARE TO AUTOMATICALLY DETERMINE IS A DETECTOR WITH THE PROPOSED MODIFICATION IS INSTALLED ON THE SYSTEM AND PROPERLY SELECT THE PROPER CONFIGURATION TABLE; AND 4) CORRESPONDING CHANGES IN THE INCOMING ACCEPTANCE CRITERIA TESTING STATION FOR THE MODIFIED DETECTOR.
P020014|S030|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2010|02/15/2010|||OK30|MODIFICATION OF THE RAW MATERIAL IN THE PACKAGING POUCH OF THE ESSURE® SYSTEM.
P980016|S221|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P030011|S007|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/15/2010|04/28/2010|||APPR|APPROVAL FOR THE TRADE NAME CHANGE OF THE SUBJECT DEVICE.  THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART AND IS INDICATED FOR USE IN TRANSPLANT-ELIGIBLE CANDIDATES IN IMMINENT DANGER OF DEATH FROM IRREVERSIBLE BIVENTRICULAR FAILURE.
P830061|S048|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, CAPSURE SP LEADS, AND CAPSURE SENSE LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P850089|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P890003|S183|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|WRENCH KIT|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P900061|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD END PIN, ACTIVE CAN EMULATOR HEADER, SIZING & UPSIZING SLEEVE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P030031|S025|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/2010|12/21/2011|||APPR|APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS:1) REDUCED RECOMMENDED SALINE FLOW RATE (REDUCE BY ~50%); 2) INCREASE IN NUMBER OF IRRIGATION HOLES (FROM 6 TO 56); 3) DECREASE IN SIZE OF IRRIGATION HOLES (FROM 0.016" TO 0.0035" DIAMETER);4) MODIFIED TIP ELECTRODE MATERIAL (FROM 90% PLATINUM/10% IRIDIUM TO 80% PALLADIUM/20% PLATINUM); AND 5) UPDATE STOCKERT 70 RF GENERATOR SOFTWARE (VL.035 TO VL.037).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BI-DIRECTIONAL CARTO XP THERMOCOOL SF NAY CATHETER, BI-DIRECTIONAL CARTO 3 THERMOCOOL SF NAY CATHETER, AND BIDIRECTIONALTHERMOCOOL SF CATHETER AND IS INDICATED FOR:THE BIOSENSE WEBSTER THERMOCOOL SF NAV DIAGNOSTIC/ ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF 1) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER; AND 2) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.THE THERMOCOOL SF NAV DIAGNOSTIC/ ABLATION DEFLECTABLE TIP CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH COMPATIBLE CARTO EP NAVIGATION SYSTEMS.  THE BIOSENSE WEBSTER THERMOCOOL SF DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER ANDRELATED ACCESSORIES ARE INDICATED FOR USE IN CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICALMAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THETREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.
P920015|S057|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD ADAPTOR, IS-1 PORT PIN PLUG, SPRINT, SPRINT FIDELIS, QUATTRO, QUATTRO SECURE & SUBCUTANEOUS DEFIBRILLATION LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P950024|S018|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR AND CAPSURE EPI BIPOLAR LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P980050|S045|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CS-SVC TRANSVENE LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P030036|S014|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2010|03/16/2010|||APPR|APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
P990071|S009|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER|OAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/15/2010|12/21/2011|||APPR|APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS:1) REDUCED RECOMMENDED SALINE FLOW RATE (REDUCE BY ~50%); 2) INCREASE IN NUMBER OF IRRIGATION HOLES (FROM 6 TO 56); 3) DECREASE IN SIZE OF IRRIGATION HOLES (FROM 0.016" TO 0.0035" DIAMETER);4) MODIFIED TIP ELECTRODE MATERIAL (FROM 90% PLATINUM/10% IRIDIUM TO 80% PALLADIUM/20% PLATINUM); AND 5) UPDATE STOCKERT 70 RF GENERATOR SOFTWARE (VL.035 TO VL.037).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BI-DIRECTIONAL CARTO XP THERMOCOOL SF NAY CATHETER, BI-DIRECTIONAL CARTO 3 THERMOCOOL SF NAY CATHETER, AND BIDIRECTIONAL THERMOCOOL SF CATHETER AND IS INDICATED FOR: THE BIOSENSE WEBSTER THERMOCOOL SF NAV DIAGNOSTIC/ ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF 1) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER; AND 2) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.  THE THERMOCOOL SF NAV DIAGNOSTIC/ ABLATION DEFLECTABLE TIP CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH COMPATIBLE CARTO EP NAVIGATION SYSTEMS.THE BIOSENSE WEBSTER THERMOCOOL SF DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORIES ARE INDICATED FOR USE IN CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.
P010031|S181|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||ATTAIN SD LH LEAD/INSYNC SENTRY/INSYNC MAXIMO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P060039|S009|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P030036|S015|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P010015|S077|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN OTW/ATTAIN LV LEAD/ATTAIN CS LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P980050|S046|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CSS-SVC TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P980016|S222|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSUREFIX LEAD/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO FAMILY OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P950024|S019|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR & BIPOLAR LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P930039|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SUREFIX LEAD/CAPSUREFIX LEAD/CAPSUREFIX NOVUS/PIROUET|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P920015|S058|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT/SPRINT QUATTRO/SPRINT QUATTRO SECURE LEAD/TRANSVENE SVC/DF-1 LEADS/SPRINT QUATTRO SINGLE COIL/END CAP ACCESSORY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P900061|S086|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD & SIZING/UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P890003|S184|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD LEADS/VITATRON LEGACY DR/D/II/VISA/CAPSURE LEAD/BRILLIANT S+VDD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P850089|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z/NOVUS LEADS/ CAPSURE SP/NOVUS LEADS/EXCELLENCE S+/IMPULSE/VITATRON IMPULSE II|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P830061|S049|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEADS/CAPSURE LEADS/CAPSURE SP LEADS/CAPSURE SENSE/EXCELLENCE PS +/EXCELLENCE +|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P000053|S027|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS MODEL 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|IMPLEMENTATION OF A NEW, DUPLICATE MOLD FOR A COMPONENT OF THE PUMP ASSEMBLY.
P930014|S038|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF & ACRYSOF RESTOR INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|CHANGE IN THE CURRENT RADIUS RADIUSCOPE FOR THE PROCESSING OF THE DEVICE.
P040020|S023|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF AND ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|CHANGE IN THE CURRENT RADIUS RADIUSCOPE FOR THE PROCESSING OF THE DEVICE.
P080011|S002|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/18/2010|||OK30|ADDITION OF A NEW QUALIFIED VENDOR OF THE RAW MATERIAL FOR THE DEVICE.
P070015|S031|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|10/29/2010|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE SYRINGE IN A MANUFACTURING PROCESS.
P060008|S039|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/03/2010|||OK30|REMOVAL OF AN IN-PROCESS INSPECTION WHICH IS PERFORMED ON THE INNER DIAMETER (ID) OF THE STENT COMPONENT.
P040016|S049|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2010|02/03/2010|||OK30|REMOVAL OF AN IN-PROCESS INSPECTION WHICH IS PERFORMED ON THE INNER DIAMETER (ID) OF THE STENT COMPONENT.
P080013|S003|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/20/2010|02/18/2011|||APPR|APPROVAL FOR THE REPLACEMENT OF THE CURRENT DURASEAL SPINE SEALANT POLYETHYLENE GLYCOL (PEG) FORMULATION WITH A LOWER MOLECULAR WEIGHT FORMULATION.
P850007|S030|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM/SPINAL-STIM|LOF|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|01/12/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN LEWISVILLE, TEXAS.
P000032|S032|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|09/02/2010|||APPR|APPROVAL FOR A CHANGE TO THE CONSOLE TESTING METHOD.
P030034|S004|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL-STIM|LOF|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|01/12/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN LEWISVILLE, TEXAS.
P860057|S066|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES MODELS 2700/2700TFX/2800/2800TFX/3000/3000TFX/3300TFX/6900P/PTFX|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/18/2010|||OK30|ALTERNATE SUPPLIERS FOR MOLDING OF CLIPS AND SLEEVES.
P000007|S024|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/18/2010|||OK30|ALTERNATE SUPPLIERS FOR MOLDING OF CLIPS AND SLEEVES.
P870056|S038|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/18/2010|||OK30|ALTERNATE SUPPLIERS FOR MOLDING OF CLIPS AND SLEEVES.
P010041|S023|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS MODEL 2650|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/18/2010|||OK30|ALTERNATE SUPPLIERS FOR MOLDING OF CLIPS AND SLEEVES.
P870077|S035|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS MODELS 6625L/6625-ESR-LP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/18/2010|||OK30|ALTERNATE SUPPLIERS FOR MOLDING OF CLIPS AND SLEEVES.
P080004|S004|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/21/2010|04/04/2012|||APPR|APPROVAL FOR CLEAR-OPTIC SPHERIC AND ASPHERIC SURFACE INTRAOCULAR LENSES (IOLS), MODELS PC-60R, PC-60AD AND FC-60AD.
P980035|S157|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/19/2010|||OK30|CHANGE IN THE CLEAN ROOM MONITORING FREQUENCY.
P890003|S185|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/THERA I IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/19/2010|||OK30|CHANGE IN THE CLEAN ROOM MONITORING FREQUENCY.
P970012|S063|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/19/2010|||OK30|CHANGE IN THE CLEAN ROOM MONITORING FREQUENCY.
P980016|S223|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/19/2010|||OK30|CHANGE IN THE CLEAN ROOM MONITORING FREQUENCY.
P010015|S078|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P/INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/19/2010|||OK30|CHANGE IN THE CLEAN ROOM MONITORING FREQUENCY.
P010031|S182|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2010|02/19/2010|||OK30|CHANGE IN THE CLEAN ROOM MONITORING FREQUENCY.
P030017|S098|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/2010|05/06/2010|||APPR|APPROVAL FOR A CONSOLIDATION OF THREE SEPARATE INSTRUCTION MANUALS (I.E., PHYSICIAN IMPLANT, PHYSICIAN LEAD, AND PHYSICIAN SURGICAL LEAD MANUALS) INTO A SINGLE MANUAL, THE PHYSICIAN SYSTEM CLINICAL MANUAL.
P000032|S033|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2010|09/22/2010|||APPR|APPROVAL FOR A CHANGE TO THE INCOMING MEASUREMENT METHOD.
P930038|S061|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/22/2010|||OK30|ALTERNATE DEPLOYMENT TESTING METHOD FOR THE ANGIO-SEAL PLUS VASCULAR CLOSURE DEVICE.
P040045|S010|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/23/2010|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR AN INERT DILUENT USED IN THE PRODUCTION OF THE DEVICE.
P000032|S034|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/23/2010|||OK30|INTRODUCTION OF A PNEUMATICALLY OPERATED MANUFACTURING FIXTURE TO SWAGE COMPONENTS.
P000029|S063|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/23/2010|||OK30|CHANGE IN BIOBURDEN TESTING PROCEDURES OF THE DEFLUX GEL.
P060033|S048|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2009|02/26/2010|||OK30|CHANGE TO THE INITIAL CRIMP STENT PROCESS.
P060008|S040|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/22/2010|||OK30|ADDITION OF AN ALTERNATE AUTOMATED STENT FINISHING PROCESS.
P040016|S050|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/22/2010|||OK30|ADDITION OF AN ALTERNATE AUTOMATED STENT FINISHING PROCESS.
P910023|S229|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|06/28/2010|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF AN ELECTRONIC ASSEMBLY MODULE.
P060040|S006|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE 2 LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/25/2010|04/19/2010|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE PUMP END BEND RELIEF (PEBR) REGION OF THE HEARTMATE II PERCUTANEOUS LEAD.
P030054|S144|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|06/28/2010|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF AN ELECTRONIC ASSEMBLY MODULE.
P010031|S183|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/22/2010|||OK30|ENHANCEMENT OF THE SOFTWARE USED IN THE LASER RIBBON BONDING (LRB) LOOP HEIGHT MEASUREMENT.
P980016|S224|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/22/2010|||OK30|ENHANCEMENT OF THE SOFTWARE USED IN THE LASER RIBBON BONDING (LRB) LOOP HEIGHT MEASUREMENT.
P860057|S067|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS MODELS 2700/TFX/2800/TFX/3000/TFX/3300TFX/6900/P/PTFX/7000/TFX|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/24/2010|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS OF 3.0% HYDROGEN PEROXIDE.
P870056|S039|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS MODELS 2625/6625|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/24/2010|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS OF 3.0% HYDROGEN PEROXIDE.
P870077|S036|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODELS 6625LP/6625-ESR-LP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/24/2010|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS OF 3.0% HYDROGEN PEROXIDE.
P010041|S024|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2010|02/24/2010|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS OF 3.0% HYDROGEN PEROXIDE.
P000032|S035|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/25/2010|||OK30|ADDITION OF A NEW MANUFACTURING PIECE OF EQUIPMENT TO ASSIST IN THE PRODUCTION PROCESS.
P060008|S041|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/25/2010|||OK30|CHANGE TO AN AUTOMATED INSPECTION PROCESS.
P040016|S051|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/25/2010|||OK30|CHANGE TO AN AUTOMATED INSPECTION PROCESS.
P950020|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/25/2010|||OK30|CHANGE TO AN AUTOMATED INSPECTION PROCESS.
P860019|S248|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK2 PTCA CATHETER/APEX PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/25/2010|||OK30|CHANGE TO AN AUTOMATED INSPECTION PROCESS.
P040016|S052|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P060008|S042|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P030025|S082|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P970004|S079|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/26/2010|04/13/2010|||APPR|APPROVAL FOR A CHANGE TO THE HUB MATERIAL OF THE FORAMEN NEEDLE IN THE MEDTRONIC INTERSTIM ACCESSORY KITS (MODELS 041828, 041829, AND 3065U).
P020009|S058|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P950020|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON DILATATIONS DEVICE|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P860019|S249|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P930031|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P940019|S022|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT LLIAC ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P980033|S016|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P050019|S003|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P060006|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P900056|S097|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ATHERECTOMY DEVICES|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P980003|S022|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILI/CHILI II COOLED ABLATION SYSTEM AND CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P920047|S041|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER PRIME/BLAZER II/BLAZER XP/BLAZER HTD TEMPERATURE ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P020025|S022|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP CARDIAC ABLATION SYSTEM CONTROLLER AND ACCESSORIES AND MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P030017|S099|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2010|02/22/2010|||OK30|CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
P870076|S009|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING BAND AND APPLICATOR SYSTEMS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2010|02/25/2010|||OK30|CHANGE IN SUPPLIERS OF TWO COMPONENTS.
P990009|S028|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2010|02/26/2010|||OK30|CHANGE IN: 1) THE DRYING CYCLE TIME FRO THE BOVINE GELATIN MANUFACTURING PROCESS; AND 2) THE TEMPERATURE FOR THE GELATIN MANUFACTURING PROCESS.
P960009|S077|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA/KINETRA IMPLANTABLE NEUROSTIMULATORS/ACTIVA PC & RC|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2010|02/26/2010|||OK30|REDUCTION IN THE FREQUENCY OF ROUTINE MONITORING IN THE CONTROLLED ENVIRONMENT AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO.
P840001|S146|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3/SYNERGY/RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2010|02/26/2010|||OK30|REDUCTION IN THE FREQUENCY OF ROUTINE MONITORING IN THE CONTROLLED ENVIRONMENT AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO.
P970004|S080|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/INTERSTIM II IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2010|02/26/2010|||OK30|REDUCTION IN THE FREQUENCY OF ROUTINE MONITORING IN THE CONTROLLED ENVIRONMENT AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO.
P860004|S119|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PUMP/INTRATHECAL CATHETERS/INTRATHECAL CATHETERS/PUMP/SPINAL SEGMENT REVISION KITS/SUTURELESS PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2010|02/26/2010|||OK30|REDUCTION IN THE FREQUENCY OF ROUTINE MONITORING IN THE CONTROLLED ENVIRONMENT AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO.
P020009|S059|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2010|02/22/2010|||OK30|CHANGE TO AN ELECTROPOLISHING SOLUTION CHANGE-OUT TIMEFRAME.
P860004|S120|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II &  ISOMED IMPLANTABLE INFUSION PUMPS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/2010|02/26/2010|||APPR|APPROVAL FOR CHANGES TO THE SYNCHROMED II INFUSION SYSTEM PATIENT MANUAL.
P990034|S016|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II & ISOMED IMPLANTABLE INFUSION PUMPS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/2010|02/26/2010|||APPR|APPROVAL FOR CHANGES TO THE SYNCHROMED ISOMED IMPLANTABLE INFUSION SYSTEM PATIENT MANUAL.
P060006|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2010|05/28/2010|||APPR|APPROVAL FOR REINSTATEMENT OF A SECONDARY STERILIZATION SITE FORMERLY OWNED BY STERIS ISOMEDIX SERVICES, INC. (STERIS) LOCATED IN COVENTRY, RHODE ISLAND.
P940015|S017|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC-ONE (HYLAN G-F 20)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2010|03/12/2010|||OK30|CHANGE TO THE AUTOMATED FILLING PROCESS FOR THE SYNVISC-ONE SYRINGES FROM USING THE COZZOLI FILLER TO USING THE INOVA VACUUM FILLER.
P070014|S009|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2010|06/11/2010|||APPR|APPROVAL FOR A SECOND STERILIZATION CYCLE.
P080006|S006|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY  MODEL 4196 LEFT VENTRICULAR LEAD|OJX|CV|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|01/29/2010|10/04/2012|||APPR|APPROVAL FOR COMPONENT LEVEL ANALYTICAL TESTING FOR RELEASE OF THE MODEL 4196, 4296 AND 4396.
P060022|S006|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS ADVANCED OPTICS ASPHERIC LENS AND AKROES AO MICRO INCISION LENS|HQL|OP|Real-Time Process||N|01/29/2010|04/01/2010|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO MODEL MI60L AND USE OF MEDICEL VISCOJECT 2.2 LP60430 INSERTER WITH MODEL AO60 AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA.
P070015|S032|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/04/2010|||OK30|ADDITION OF AN UPGRADED PACKAGING SEALER.
P840001|S147|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION (SCS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/03/2010|||OK30|ADDITION OF A SECOND LASER WELDING WORKSTATION AND POWER SUPPLY.
P960009|S078|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION (DBS)|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/03/2010|||OK30|ADDITION OF A SECOND LASER WELDING WORKSTATION AND POWER SUPPLY.
P050019|S004|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/2010|07/28/2010|||APPR|APPROVAL FOR REPLACING THE PARTIALLY ENCAPSULATED RADIOPAQUE MARKERBAND ON THE DISTAL END OF THE RETRACTABLE OUTER SHEATH IN THE STENT DELIVERY SYSTEM WITH A FULLY ENCAPSULATED RADIOPAQUE MARKERBAND.
P860019|S250|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/01/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P020009|S060|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/01/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P030025|S083|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/01/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P040016|S053|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/01/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P060006|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/01/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P060008|S043|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/01/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P860004|S121|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PUMP AND INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/03/2010|||OK30|CLEANING OF PIECE PARTS IN A NEW CONTROLLED ENVIRONMENT AREA (CEA) WITHIN THE SAME EXISTING FACILITY.
P970004|S081|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION (SNS) THERAPY FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2010|03/03/2010|||OK30|CLEANING OF PIECE PARTS IN A NEW CONTROLLED ENVIRONMENT AREA (CEA) WITHIN THE SAME EXISTING FACILITY.
P840001|S148|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|OCTAPOLAR EXTENSION/SPECIFY SURGICAL LEAD KIT|LGW|NE|30-Day Notice||N|02/01/2010|03/03/2010|||OK30|CLEANING OF PIECE PARTS IN A NEW CONTROLLED ENVIRONMENT AREA (CEA) WITHIN THE SAME EXISTING FACILITY.
P030042|S002|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM|NXT|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/21/2010|07/16/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030042|S003|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL|NXT|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/21/2010|06/21/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010012|S234|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS PULSE GENERATORS - MODELS N118 & N119|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/15/2010|04/02/2010|||APPR|APPROVAL FOR 2ND SUPPLIER (IXYS) TO PROVIDE SCR/ANODE GATE THYRISTORS FOR THE SUPER OUTPUT MODULE (SOM) OF THE COGNIS/TELIGEN PGS.
P970004|S082|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY TINED LEADS, MODELS 3889 AND 3093|EZW|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/02/2010|04/02/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960040|S214|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/15/2010|04/02/2010|||APPR|APPROVAL FOR 2ND SUPPLIER (IXYS) TO PROVIDE SCR/ANODE GATE THYRISTORS FOR THE SUPER OUTPUT MODULE (SOM) OF THE COGNIS/TELIGEN PGS.
P010012|S235|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENEWAL 3 RF/LIVIAN/COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2010|03/04/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF ANTENNA TUBING.
P960040|S215|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN/CONFIENT|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2010|03/04/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF ANTENNA TUBING.
P930014|S039|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSERT C DELIVERY SYSTEM|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/02/2010|03/29/2010|||APPR|APPROVAL FOR THE ACRYSERT C DELIVERY SYSTEM WITH THE ACRYSOF IQ IOL MODEL SN6CWS.
P050020|S022|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track||N|02/02/2010|01/14/2011|||APPR|APPROVAL FOR CHANGES TO THE OUTGOING QUALITY CONTROL (QC) SOLUTION TESTING.
P890064|S021|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST  AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST|MAQ|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/03/2010|03/31/2010|||APPR|APPROVAL FOR A TRADE NAME CHANGE FOR THE HYBRID CAPTURE 2 (HC2) HIGH-RISKHPV DNA TEST AND HYBRID CAPTURE 2 (HC2) HPV DNA TEST. THE DEVICES, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST ANDDIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND ARE INDICATED FOR THE QUALITATIVE DETECTIONOF SPECIFIED TYPES OF HUMAN PAPILLOMAVIRUS (HPV) DNA IN CERVICAL SPECIMENS.
P010025|S018|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2010|03/04/2010|||OK30|CHANGE IN DEVICE SOFTWARE MANAGEMENT.
P980049|S053|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR/DR|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|04/27/2010|||APPR|APPROVAL FOR A CHANGE TO THE SOLDERING AND CLEANING PROCESSES FOR THE SHOCK 6 HYBRID MODULES.
P060027|S019|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|04/27/2010|||APPR|APPROVAL FOR A CHANGE TO THE SOLDERING AND CLEANING PROCESSES FOR THE SHOCK 6 HYBRID MODULES.
P980016|S225|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/SECURA/VIRTUOSO/VIRTUOSO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/05/2010|||OK30|CHANGE IN A VENDOR¿S EPITAXY SUPPLIER.
P010031|S184|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/II/CONSULTA/INSYNC II/III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/05/2010|||OK30|CHANGE IN A VENDOR¿S EPITAXY SUPPLIER.
P030005|S061|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR FAMILY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/04/2010|||OK30|ADDITION OF A REED SWITCH TEST AT THE REED SWITCH COMPONENT SUPPLIER.
P940031|S066|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/04/2010|||OK30|ADDITION OF A REED SWITCH TEST AT THE REED SWITCH COMPONENT SUPPLIER.
P960040|S217|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK FAMILY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/04/2010|||OK30|ADDITION OF A REED SWITCH TEST AT THE REED SWITCH COMPONENT SUPPLIER.
P030054|S145|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/05/2010|||OK30|ALTERNATE SUPPLIERS FOR VARIOUS DISCRETE COMPONENTS.
P910023|S230|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/05/2010|||OK30|ALTERNATE SUPPLIERS FOR VARIOUS DISCRETE COMPONENTS.
P030035|S066|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/05/2010|||OK30|ALTERNATE SUPPLIERS FOR VARIOUS DISCRETE COMPONENTS.
P880086|S185|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2010|03/05/2010|||OK30|ALTERNATE SUPPLIERS FOR VARIOUS DISCRETE COMPONENTS.
P060027|S020|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2010|03/04/2010|||OK30|ADDITION OF A NEW LASER WELDING SOURCE AND CONTROLLED ATMOSPHERE FIXTURE.
P010031|S185|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC II PROTECT/SENTRY/MARQUIS/MAXIMO ICDS/CONCERTO/CONSULTA/MAXIMO II/CONCERTO II CRT-DS||CV|30-Day Notice||N|02/05/2010|03/05/2010|||OK30|CHANGE IN A VENDOR¿S EPITAXY SUPPLIER.
P910077|S102|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2010|04/06/2010|||APPR|APPROVAL FOR CHANGES TO THE LATITUDE REGULATED APPLICATION SOFTWARE ON LATITUDE SYSTEM SERVER (MODEL 6488, V6.0).
P980022|S068|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2010|04/05/2010|||APPR|APPROVAL FOR MODIFICATION TO THE PARADIGM REAL-TIME INSULIN PUMP TO ADD AN INSULATION PAD TO THE PUMP MOTOR FLEX CABLE AND IS INDICATED FOR CONTINUOUS DELIVERY OF INSULIN AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN.  IN ADDITION TO DELIVERY OF INSULIN, THE PARADIGM INSULIN PUMP IS DESIGNED TO RECEIVE AND DISPLAY REAL-TIME GLUCOSE VALUES RECEIVED VIA A COMPATIBLE TRANSMITTING DEVICE.
P980016|S226|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2010|03/05/2010|||OK30|CHANGE IN A VENDOR¿S EPITAXY SUPPLIER.
P900056|S098|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2010|09/23/2010|||APPR|APPROVAL FOR A MANUFACTURING PRODUCTION AREA MOVE OF THE MANUFACTURE AND SERVICE OF THE DEVICE CONSOLE AND DYNAGLIDE FOOT PEDAL ASSEMBLIES.
P030054|S146|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/2010|05/03/2010|||APPR|APPROVAL FOR: 1) THE ADDITION OF THE PACING SYSTEMS ANALYZER (PSA) MODEL EX3100.  THE MODEL EX3100 ALSO INCLUDES ACCESSORIES: A) MERLIN ANTENNA ADAPTER EX3190; B) MERLIN CABLE ADAPTER EX3170; AND C) MERLIN ¿M¿ ADAPTER EX3180; AND 2) THE ADDITION OF THE MODEL 3330 VERSION 10.1.1 SOFTWARE.
P040002|S026|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM FOR AAA|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/05/2010|07/28/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE SUPRARENAL PROXIMAL EXTENSION ACCESSORY AND FOR ADDITIONAL LENGTHS OF SUPRARENAL AND INFRARENAL PROXIMAL EXTENSION ACCESSORIES.
P860004|S122|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2010|03/05/2010|||OK30|NEW INSPECTION STEPS AND MOLDING EQUIPMENT USED IN THE MANUFACTURE OF THE SUTURELESS CONNECTOR PROXIMAL CATHETER THAT IS INCLUDED IN MODELS 8709SC, 8731SC, AND 8596SC.
P990025|S023|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2010|03/04/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE MU-SHIELD USED IN THE MANUFACTURE OF THE NAVIGATIONAL CATHETERS.
P010068|S019|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2010|03/04/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE MU-SHIELD USED IN THE MANUFACTURE OF THE NAVIGATIONAL CATHETERS.
P030031|S026|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2010|03/04/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE MU-SHIELD USED IN THE MANUFACTURE OF THE NAVIGATIONAL CATHETERS.
P040036|S019|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2010|03/04/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE MU-SHIELD USED IN THE MANUFACTURE OF THE NAVIGATIONAL CATHETERS.
P040027|S019|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|09/15/2010|||APPR|APPROVAL FOR AUTOMATING THE LOADING OF THE ACCESS SLEEVE AND TO USE AN ALTERNATE MATERIAL VENDOR.
P040047|S016|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/11/2010|||OK30|CHANGE TO THE ENVIRONMENTAL CONDITIONS IN THE CLEAN ROOM.
P000012|S023|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/08/2010|||OK30|ELIMINATION OF FUNCTIONAL TESTING AT THE INCOMING RAW MATERIAL STAGE FOR A KIT COMPONENT USED IN THE DEVICE.
P040045|S011|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|CHANGE IN A QUALITY CONTROL TEST METHOD FOR THE FINISHED DEVICE.
P050037|S022|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|EVALUATION FOR THE CLEAN ROOM.
P050052|S025|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|EVALUATION FOR THE CLEAN ROOM.
P060033|S049|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/12/2010|04/28/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010031|S186|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA/MAXIMO II/CONCERTO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|ELIMINATION OF HYBRID SCREENING STEP.
P980016|S227|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/ MAXIMO II DR/VR/VIRTUOSO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|ELIMINATION OF HYBRID SCREENING STEP.
P870072|S043|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|TLC-2PLUS PORTABLE VAD DRIVER|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2010|03/30/2010|||APPR|APPROVAL FOR A FIRMWARE MODIFICATION TO THE OCCLUSION ALARM ALGORITHM IN THE TLC-IIPLUS.
P040044|S025|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|07/09/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW, SINGLE PROGRAMMABLE CONDITIONING CHAMBER.
P980018|S008|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/08/2010|||OK30|CHANGE IN THE MANUFACTURING FILLING PROCESS TO INCREASE THE REAGENT FILL VOLUME TO ADDRESS SHORTAGE CONCERNS.
P950029|S051|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY SR 2250/SYMPHONY DR 2550/RHAPSODY SR 2210/RHAPSODY DR 2510 & 2530|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|CHANGING FROM MANUAL TO AUTOMATED CLEANING PROCESS.
P950032|S056|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2010|04/09/2010|||APPR|APPROVAL FOR THE INTRODUCTION OF KERATINOCYTE CELL STRAIN (HEP072) INTO THE MANUFACTURE OF APLIGRAF.
P980049|S054|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR 6250 & OVATIO DR 6550|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|CHANGING FROM MANUAL TO AUTOMATED CLEANING PROCESS.
P060027|S021|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT 6750|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|CHANGING FROM MANUAL TO AUTOMATED CLEANING PROCESS.
P950037|S077|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SETROX S & DEXTRUS LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR LEAD SPRING AND EXTERNAL SLEEVE.
P980023|S039|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX SD & LINOX S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR LEAD SPRING AND EXTERNAL SLEEVE.
P950005|S029|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS/EZ STEER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE THERMISTOR TEMPERATURE SENSOR USED IN THE MANUFACTURE OF ABLATION CATHETERS.
P990025|S024|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR/EZ STEER NAV/QWIKSTAR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE THERMISTOR TEMPERATURE SENSOR USED IN THE MANUFACTURE OF ABLATION CATHETERS.
P030031|S027|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE THERMISTOR TEMPERATURE SENSOR USED IN THE MANUFACTURE OF ABLATION CATHETERS.
P040036|S020|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2010|03/12/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE THERMISTOR TEMPERATURE SENSOR USED IN THE MANUFACTURE OF ABLATION CATHETERS.
P030009|S039|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track||N|02/12/2010|09/14/2010|||APPR|APPROVAL FOR THE INTEGRITY CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVINGCORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS, WITH REFERENCE VESSEL DIAMETERS OF 2.25-4.0 MM AND <=30 MM IN LENGTH, USING DIRECT STENTING OR PREDILATATION.
P850079|S048|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY SPHERE & ASPHERE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2010|07/02/2010|||APPR|APPROVAL FOR A CHANGE TO AN AUTOMATED WET LENS INSPECTION SYSTEM.
P000029|S064|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2010|03/18/2010|||OK30|ALTERNATE SUPPLIER OF SOLUTIONS USED AS INGREDIENTS IN THE BULK MANUFACTURING PROCESS FOR PH ADJUSTMENT AND GEL STABILIZATION.
P980022|S069|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/16/2010|06/03/2010|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PUMP DRIVE SCREW WELD.  THE DEVICE IS INDICATED FOR CONTINUOUS DELIVERY OF INSULIN AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN.
P030047|S019|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS|NIM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/16/2010|02/14/2011|||APPR|APPROVAL FOR A CHANGE IN COLORANT USED IN THE CATHETERS OF THE PRECISE AND SMART NITINOL STENT SYSTEMS.
P960040|S218|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2010|09/07/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE CLEANING PROCESS AND MOVING A WELD PROCESS FROM A SUPPLIER TO BOSTON SCIENTIFIC CORPORATION.
P010012|S237|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2010|09/07/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE CLEANING PROCESS AND MOVING A WELD PROCESS FROM A SUPPLIER TO BOSTON SCIENTIFIC CORPORATION.
P970054|S008|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE|MYL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2010|03/19/2010|||OK30|INTRODUCTION OF A NEW PRODUCTION PROCEDURE TO PREPARE A VIRAL MASTER STOCK, AND THE DOCUMENTATION OF THE TUBING PRIMING STEPS FOR THE PLATE COATING EQUIPMENT USED IN THE DEVICE.
P970055|S008|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE|MYM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2010|03/19/2010|||OK30|NEW PRODUCTION PROCEDURE TO PREPARE A VIRAL MASTER STOCK, AND THE DOCUMENTATION OF THE TUBING PRIMING STEPS FOR THE PLATE COATING EQUIPMENT USED IN THE DEVICE.
P980040|S032|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS MULTIFOCAL ONE-PIECE INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/19/2010|||OK30|ADDITION OF AN ALTERNATE CRYOTUMBLING PROCEDURE.
P030040|S007|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC IGM ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/16/2010|||OK30|ALTERNATE SUPPLIER FOR A CRITICAL RAW MATERIAL USED IN THE PRODUCTION OF THE ASSAY LITE REAGENT.
P970018|S020|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/08/2010|||OK30|REPLACE THE OFF-THE-SHELF VACUUM PUMP WITH AN ALTERNATE MODEL TO COMPENSATE FOR A CHANGE IN THE SUPPLIER.
P030017|S100|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track||N|02/18/2010|07/19/2010|||APPR|APPROVAL FOR THE INTRODUCTION OF THE LINEAR 3-4 AND 3-6 SPINAL CORD STIMULATION LEADS, WHICH HAVE ELECTRODE CONTACT SPACINGS OF 4 MM AND 6 MM, RESPECTIVELY.
P070006|S004|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT .TB TEST|OJN|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/19/2010|||OK30|ADDITION OF AN EXTRA APPROVED SUPPLIER (US BIOLOGICAL, INC.) OF PHYTOHEMAGGLUTININ AND OF ANOTHER SUPPLIER (THERMO FISHER SCIENTIFIC GMBH) OF ANTIGEN PEPTIDES (PANELS A AND B) FOR THE T-SPOT®.TB KITS.
P980035|S158|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/18/2010|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P970012|S064|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/18/2010|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P980016|S228|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/18/2010|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P990001|S061|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C& T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/18/2010|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P010015|S079|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC & INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/18/2010|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P010031|S187|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/18/2010|||OK30|CHANGE IN LOCATION OF A STERILIZATION SYSTEM.
P980035|S159|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/ RELIA/SIGMA/ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/19/2010|||OK30|CHANGE IN HOW THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM WAS CONTROLLED.
P980016|S229|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/19/2010|||OK30|CHANGE IN HOW THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM WAS CONTROLLED.
P010031|S188|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC III MARQUIS/PROTECT/INSYNC SENTRY/MAXIMO ICD/CONCERTO/II/MAXIMO II/CONSULTA CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/19/2010|||OK30|CHANGE IN HOW THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM WAS CONTROLLED.
P010015|S080|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/19/2010|||OK30|CHANGE IN HOW THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM WAS CONTROLLED.
P990001|S062|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2010|03/19/2010|||OK30|CHANGE IN HOW THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM WAS CONTROLLED.
P040044|S026|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2010|03/17/2010|||OK30|ADDITION OF A NEW ADHESIVE AND ASSOCIATED MANUFACTURING EQUIPMENT.
P060039|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/19/2010|06/30/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050017|S005|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT AND SILVER VASCULAR STENT|NIO|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2010|04/12/2010|||APPR|APPROVAL FOR REVISED PRODUCT LABELING.
P010031|S189|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA/MAXIMO II/CONCERTO II/CONCERTO CRT-DS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2010|07/16/2010|||APPR|APPROVAL FOR AUTOMATION OF DIMENSIONAL TESTING.
P980016|S230|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/ENTRUST/VIRTUOSO|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2010|07/16/2010|||APPR|APPROVAL FOR AUTOMATION OF DIMENSIONAL TESTING.
P980035|S160|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SIGMA/MEDTRONIC 350 SERIES/ENRHYTHM IPG/ADAPTA/SENSIA/RELIA/VERSA|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2010|07/16/2010|||APPR|APPROVAL FOR AUTOMATION OF DIMENSIONAL TESTING.
P990001|S063|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2010|07/16/2010|||APPR|APPROVAL FOR AUTOMATION OF DIMENSIONAL TESTING.
P010015|S081|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III (IPG)|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2010|07/16/2010|||APPR|APPROVAL FOR AUTOMATION OF DIMENSIONAL TESTING.
P020049|S002|LEMAITRE VASCULAR INC|63 SECOND AVENUE||BURLINGTON|MA|01803||TISSUE GRAFT OF 6MM AND GREATER|PROCOL VASCULAR BIOPROSTHESIS|LXA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2010|03/23/2010|||OK30|ADDITION OF A NEW DISTRIBUTION SITE.
P040044|S027|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|5F & 6/7F MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/2010|03/24/2010|||APPR|APPROVAL FOR LABELING CHANGES.
P000029|S065|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2010|06/01/2010|||APPR|APPROVAL FOR CHANGING THE STERILIZATION METHOD TO GAMMA RADIATION, CHANGING THE PACKAGING MATERIALS, AND OUTSOURCING THE MANUFACTURING OF THE DEFLUX NEEDLE COMPONENT.
P040014|S013|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION CATHETER/THERAPY 4MM THERMISTOR/THERAPY BI-DIRECTIONAL CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2010|03/23/2010|||OK30|ADDITION OF A LARGER STERILIZATION CHAMBER.
P040042|S018|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2010|03/23/2010|||OK30|ADDITION OF A LARGER STERILIZATION CHAMBER.
P060019|S011|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2010|03/23/2010|||OK30|ADDITION OF A LARGER STERILIZATION CHAMBER.
P050007|S024|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STAR CLOSE AND STAR CLOSE SE VASCULAR CLOSURE SYSTEMS|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2010|04/22/2010|||APPR|APPROVAL FOR CHANGES TO THE POUCH DESIGN AND PACKAGING METHODS.
P810046|S234|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|VOYAGER NC CORONARY DILATATION CATHETER|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2010|03/26/2010|||OK30|CHANGE IN IRRADIATION EQUIPMENT.
P080004|S005|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|INTRAOCULAR LENS|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2010|07/30/2010|||APPR|APPROVAL FOR A CHANGE TO THE DIMENSIONAL INSPECTION PROCESS.
P020011|S002|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT & APTIMA HCV RNA QUALITATIVE ASSAY|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2010|09/17/2010|||APPR|APPROVAL FOR A CHANGE IN QUALITY CONTROL SPECIFICATIONS FOR THE HCV CALIBRATORS.
P010047|S001|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND'S PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/23/2010|02/17/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000058|S036|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/24/2010|05/17/2010|||APPR|APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BROCHURE.
P000054|S024|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/24/2010|05/17/2010|||APPR|APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BROCHURE.
P900009|S032|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN 4000+|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2010|03/26/2010|||OK30|COMPONENT MANUFACTURER SITE CHANGE.
P070008|S015|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW-L BP LEFT VENTRICULAR PACING LEAD|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/2010|12/23/2010|||APPR|APPROVAL FOR THE COROX OTW-L BP MODEL LEFT VENTRICULAR LEAD WHICH INCORPORATES A DIFFERENT DISTAL TIP GEOMETRY COMPARED TO THE MARKET-APPROVED COROX OTW BP LEADS.
P940013|S010|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CIBA VISION (VASURFILCON A) SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2010|04/13/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT P.T. CIBA VISION BATAM, BATAM ISLAND, INDONESIA FOR FRONT-END PROCESSING OF THE DEVICE.
P950039|S021|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSOR 2000/3000|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2010|03/18/2010|||OK30|ALTERNATE VENDOR FOR THE MEMBRANE MATERIAL FOR THE MANUFACTURE OF THE THINPREP GYN FILTER USED IN THE THINPREP PROCESSOR 2000 AND THINPREP PROCESSOR 3000.
P980018|S009|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST KIT|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/2010|10/07/2010|||APPR|APPROVAL FOR A CHANGE IN THE FORMULATION OF THE HERCEPTEST EPITOPE RETRIEVAL SOLUTION.
P000029|S066|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2010|09/03/2010|||APPR|APPROVAL FOR CHANGES TO THE SAMPLING FOR TESTING ENDOTOXINS AND BIOBURDEN AND CHANGES TO THE MANUFACTURING PROCESS.
P050006|S016|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2010|01/05/2011|||APPR|APPROVAL FOR UPDATED DEVICE LABELING.
P000037|S019|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2010|09/23/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN AUSTIN, TEXAS.
P030025|S084|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2010|03/26/2010|||OK30|CHANGE TO THE ACCEPTANCE CRITERIA AND TESTING METHOD OF THE STENT PROTECTOR.
P060008|S044|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2010|03/26/2010|||OK30|CHANGE TO THE ACCEPTANCE CRITERIA AND TESTING METHOD OF THE STENT PROTECTOR.
P950027|S012|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2010|03/28/2010|||OK30|ADDITION OF A NEW, FULLY AUTOMATED FILLING AND CLOSING MACHINE.
P060033|S050|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2010|03/31/2010|||OK30|ADDITION OF AN ALTERNATE LASER FOR A MANUFACTURING PROCESS.
P030009|S040|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2010|03/31/2010|||OK30|ADDITION OF AN ALTERNATE LASER FOR A MANUFACTURING PROCESS.
P000012|S024|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice||N|03/01/2010|03/24/2010|||OK30|CLEAN IN PLACE (CIP) CYCLE CHANGES AND MINOR EQUIPMENT MODIFICATIONS FOR THE SCALE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES.
P060030|S009|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2010|03/24/2010|||OK30|CLEAN IN PLACE (CIP) CYCLE CHANGES AND MINOR EQUIPMENT MODIFICATIONS FOR THE SCALE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES.
P000029|S067|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2010|10/26/2010|||APPR|APPROVAL TO EXTEND THE SHELF LIFE TO 24 MONTHS AFTER MANUFACTURE.
P890003|S186|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/THERA I IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P070022|S002|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2010|04/15/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTEST LABORATORIES, INC.MINNEAPOLIS, MINNESOTA.
P820003|S093|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P970037|S003|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA XPRESS HAFP TEST SYSTEM|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2010|01/12/2011|||APPR|APPROVAL TO EXTEND THE AUTODELFIA HAFP KIT ONTO THE DELFIA XPRESS INSTRUMENT.  THE MODIFIED VERSION, NAMELY, DELFIA XPRESS HAFP KIT IS DESIGNED TO BE USED WITH THE 6000 DELFIA XPRESS CLINICAL RANDOM ACCESS SCREENING PLATFORM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DELFIA XPRESS HAFP KIT AND IS INDICATED FOR `THE QUANTITATIVE DETERMINATION OF HUMAN ALPHA-FETOPROTEIN (AFP) IN MATERNAL SERUM AND AMNIOTIC FLUID OBTAINED BETWEEN THE 15TH AND 20TH WEEKS OF GESTATION.  THE ASSAY IS TO BE PERFORMED ON THE 6000 DELFIA XPRESS CLINICAL RANDOM ACCESS SCREENING PLATFORM AND IS INTENDED FOR USE ONLY IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY AS AN AID IN THE DETECTION OF OPEN NEURAL TUBE DEFECTS (ONTDS).
P930022|S011|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P850051|S072|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P010015|S082|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III (IPG)|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P900061|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD & SIZING/UPSIZING SLEEVE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P010031|S191|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P970012|S065|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980016|S232|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980035|S161|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SIGMA/MEDTRONIC 350 SERIES/ENRHYTHM IPG/ADAPTA/SENSIA/RELIA/VERSA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980050|S047|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CSS-SVC TRANSVENE LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P990001|S064|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2010|05/11/2010|||APPR|APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE.  THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P000036|S007|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|03/26/2010|||OK30|REMOVAL OF THE IN PROCESS ASSAY FROM THE DERMAGRAFT MANUFACTURING PROCESS.
P990004|S017|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM HEMOSTATIC MATRIX KIT|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/02/2010|05/31/2011|||APPR|APPROVAL FOR CHANGES TO THE RECONSTITUTION OF METHOD FOR THE THROMBIN COMPONENT AND MODIFIED THE METHOD OF MIXING WITH THE POWDERED GELATIN COMPONENT.
P950037|S078|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|LUMAX 540 VR-T DX ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/02/2010|04/30/2010|||APPR|APPROVAL FOR INTRODUCTION OF THE LUMAX 540 VR-T DX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), A SINGLE LEAD ICD SYSTEM USED IN CONJUNCTION WITH THE CURRENTLY APPROVED KAINOX A+ ICD LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX 540 VR-T DX ICD AND IS INDICATED FOR PROVIDING VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
P910077|S103|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE¿ COMMUNICATOR RF|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|04/01/2010|||OK30|USE OF NEW TEST MANAGEMENT SYSTEM AT DEVICE FINAL TEST.
P010019|S013|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|04/01/2010|||OK30|CHANGE TO THE USE OF AN AUTOMATED VISION INSPECTION SYSTEMS.
P030039|S015|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT & ACCESSORIES|NBE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/02/2010|04/05/2010|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO ADDRESS SAFETY-RELATED INFORMATION TO BRING THE LABELING INTO COMPLIANCE WITH THE EUROPEAN MEDICAL DEVICE DIRECTIVE MDD 2007/47/EC.
P970008|S047|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|03/31/2010|||OK30|REMOVAL OF A QUALITY CONTROL TEST ON AN INCOMING RAW MATERIAL COMPONENT USED IN THE MANUFACTURE OF THE TREATMENT CATHETER.
P950005|S030|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS CATHETER, NON-TEMPERATURE SENSING ABLATION CATHETERS, INTERFACE CABLES|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|10/01/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.
P990025|S025|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR CATHETER, INTERFACE CABLES|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|10/01/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.
P010068|S020|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|10/01/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.
P030031|S028|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|10/01/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.
P040036|S021|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|10/01/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.
P990071|S010|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2010|10/01/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.
P010019|S014|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2010|03/24/2010|||OK30|ALTERNATE INSPECTION SYSTEM FOR OPTICAL TOOLS.
P970008|S048|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2010|04/30/2010|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE UROLOGIX TARGIS SYSTEM COOLWAVE CONTROL UNIT MODEL 5000A.
P020045|S028|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CCT.2 CRYOCONSOLE|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2010|08/06/2010|||APPR|APPROVAL FOR THE ADDITION OF A NEW POUCH SEALER EQUIPMENT.
P070027|S015|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/03/2010|04/29/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040044|S028|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2010|03/31/2010|||OK30|MODIFICATION OF LOT RELEASE TESTING.
P050023|S029|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 540 VR-T DX ICD|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/02/2010|04/30/2010|||APPR|APPROVAL FOR INTRODUCTION OF THE LUMAX 540 VR-T DX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), A SINGLE LEAD ICD SYSTEM USED IN CONJUNCTION WITH THE CURRENTLY APPROVED KAINOX A+ ICD LEAD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX 540 VR-T DX ICD AND IS INDICATED FOR PROVIDING VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.
P050044|S013|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|ORTHOVITA'S VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2010|04/02/2010|||OK30|ALTERNATE SUPPLIER FOR A COMPONENT OF THE DEVICE.
P950018|S013|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2010|04/02/2010|||OK30|ROOM CHANGES, MECHANICAL CHANGES AND AN OVEN REPLACEMENT.
P990009|S029|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2010|03/25/2010|||APPR|APPROVAL TO ADD A WARNING TO THE LABELING TO ADDRESS THE POTENTIAL RISK TO USERS AND PATIENTS IF SINGLE USE DEVICES ARE REUSED.
P980022|S070|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MMT-7002 & MMT-7003 GLUCOSE SENSORS|MDS|CH|30-Day Notice||N|03/05/2010|03/26/2010|||OK30|CHANGE FROM A MANUAL PROCESS TO AN AUTOMATED SINGULTATION MACHINE.
N18033|S044|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) CONTACT LENS|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2010|08/09/2010|||APPR|APPROVAL FOR A CHANGE IN A TEST METHOD TO A FINISHED DEVICE CONTACT LENS MATERIAL.
P060006|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice||N|03/08/2010|04/06/2010|||OK30|CHANGE TO THE METHOD USED TO CREATE THE PROXIMAL MARKS ON THE SHAFT OF THE STENT DELIVERY SYSTEM.
P860019|S251|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK XL PTCA DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2010|04/06/2010|||OK30|CHANGE TO THE METHOD USED TO CREATE THE PROXIMAL MARKS ON THE SHAFT OF THE STENT DELIVERY SYSTEM.
P900056|S099|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2010|08/13/2010|||APPR|APPROVAL FOR: 1) CHANGE FROM IN-HOUSE MOULDING OF FOUR COMPONENTS TO AN OUTSOURCED MOULDING VENDOR; 2) A CHANGE IN THE MOULDING GATE DESIGN AND LOCATION; 3) CHANGE IN MOULDING MACHINE; AND 4) CHANGE IN THE INSPECTION PROCESS FOR THE COMPONENTS.
P030002|S022|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)|NAA|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/2010|04/30/2010|||APPR|APPROVAL TO MODIFY THE PHYSICIAN¿S LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE CRYSTALENS MODEL AT50AO LENSES IN THE +17 TO +27 DIOPTRIC POWER RANGE AND FOR MODEL AT52AO LENSES IN THE +16 TO +16.75 DIOPTRIC POWER RANGE.
P030005|S062|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2010|05/21/2010|||OK30|CHANGE IN TEST LIMITS.
P040024|S046|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2010|03/31/2010|||OK30|CHANGES TO THE PACKAGING EQUIPMENT FOR THE DEVICE.
P020009|S061|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 OTW CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2010|05/11/2010|||APPR|APPROVAL FOR MATERIAL AND SPECIFICATION CHANGES TO THE STRAIN RELIEF.
P860019|S252|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|QUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2010|05/11/2010|||APPR|APPROVAL FOR MATERIAL AND SPECIFICATION CHANGES TO THE STRAIN RELIEF.
P040016|S054|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX OTW BARE-METAL CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2010|05/11/2010|||APPR|APPROVAL FOR MATERIAL AND SPECIFICATION CHANGES TO THE STRAIN RELIEF.
P060008|S045|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE OTW & TAXUS LIBERTE ATOM OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2010|05/11/2010|||APPR|APPROVAL FOR MATERIAL AND SPECIFICATION CHANGES TO THE STRAIN RELIEF.
P030025|S085|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 CORONARY STENT SYSTEM/TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2010|05/11/2010|||APPR|APPROVAL FOR MATERIAL AND SPECIFICATION CHANGES TO THE STRAIN RELIEF.
P060006|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2010|05/11/2010|||APPR|APPROVAL FOR MATERIAL AND SPECIFICATION CHANGES TO THE STRAIN RELIEF.
P060008|S046|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/2010|02/22/2012|12M-0210|03/07/2012|APPR|APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE TAXUS LIBERTÈ PACLITAXEL-ELUTING CORONARY STENT SYSTEM.    THE TAXUS® LIBERTÈ® PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.75 MM TO 4.00 MM IN DIAMETER IN LESIONS <= 34 MM IN LENGTH; 2) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 2.50 MM IN DIAMETER IN LESIONS <= 28 MM IN LENGTH; OR 3) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRANCH BLOCK WITH SYMPTOMS OF ACUTE MYOCARDIAL INFARCTION LASTING > 20 MINUTES AND < 12 HOURS IN DURATION.
P030025|S086|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/08/2010|02/22/2012|12M-0209|03/07/2012|APPR|APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM.  THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 4.00 MM IN DIAMETER IN LESIONS<= 28 MM IN LENGTH; 2) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRANCH BLOCK WITH SYMPTOMS OF ACUTE MYOCARDIAL INFARCTION LASTING > 20 MINUTES AND < 12 HOURS IN DURATION; OR 3) WITHIN BARE METAL STENT RESTENOTIC LESIONS 2.50 MM TO 3.75 MM IN DIAMETER AND <= 28 MM IN LENGTH.
P960016|S028|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2010|04/06/2010|||OK30|REPLACEMENT OF THE CUSTOM THERMOMETER EQUIPMENT USED IN THE SENSOR TEST WITH OFF-THE-SHELF THERMOMETER EQUIPMENT.
P030017|S101|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2010|04/06/2010|||OK30|CONSOLIDATION TO A SINGLE COMPONENT SUPPLIER FOR THE ARTISAN 2X8 SURGICAL LEAD DISC ELECTRODE.
P000010|S016|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2010|04/07/2010|||OK30|CHANGES TO THE CIP PROCESS FOR THE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES, AND MINOR MODIFICATIONS TO THE HOPPER EQUIPMENT USED IN THE FORMULATION OF BULK REAGENTS FOR THE DEVICE.
P020036|S016|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/30/2010|02/14/2011|||APPR|APPROVAL FOR A CHANGE IN COLORANT USED IN THE CATHETERS OF THE PRECISE AND SMART NITINOL STENT SYSTEMS.
P030047|S020|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS|NIM|CV|30-Day Notice||N|02/16/2010|03/17/2010|||OK30|CHANGE IN PACKAGING CONFIGURATION.
P020036|S017|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART NITINOL STENT SYSTEM/SMART CONTROL NITINOL STENT SYSTEMS|NIO|CV|30-Day Notice||N|02/16/2010|03/17/2010|||OK30|CHANGE IN PACKAGING CONFIGURATION.
P070014|S010|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS|NIP|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/10/2010|12/23/2010|11M-0039|01/25/2011|APPR|APPROVAL FOR THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS.  THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS ARE INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 240 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 6.5 MM.
P020018|S034|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX ENDOVASCULAR GRAFT|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/10/2010|03/31/2010|||APPR|APPROVAL FOR THE ADDITION OF MANUFACTURING INSTRUCTIONS TO ASSURE THAT THE PROXIMAL TRIGGER WIRE IS NOT INADVERTENTLY ATTACHED TO BOTH TRIGGER KNOBS OF THE DELIVERY SYSTEM.
P040005|S004|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 FISH PHARMDX KIT|MVD|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2010|06/29/2010|||APPR|APPROVAL TO ADD AN ALTERNATE SUPPLIER AND CHANGE AN IN-PROCESS QC.
N18033|S045|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) CONTACT LENS|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2010|08/26/2010|||APPR|APPROVAL FOR A NEW IN-PROCESS CONTROL POINT.
P040045|S012|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENS|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2010|08/19/2010|||APPR|APPROVAL FOR A NEW IN-PROCESS CONTROL POINT.
P950032|S057|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2010|04/09/2010|||OK30|CHANGE IN AN ALTERNATE IN-PROCESS TRAY ASSEMBLY.
P980044|S012|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2010|10/19/2010|||APPR|APPROVAL FOR A CHANGE IN THE PLASTIC SYRINGE BARREL MOLD.
P990064|S032|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS MODEL 305|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2010|05/13/2010|||OK30|CHANGE TO THE VALVE HOLDER ASSEMBLY PROCESS AND INSPECTION DOCUMENTS.
P980043|S025|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHESIS MODEL T505|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2010|05/13/2010|||OK30|CHANGE TO THE VALVE HOLDER ASSEMBLY PROCESS AND INSPECTION DOCUMENTS.
P020024|S028|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2010|04/22/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P000039|S035|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND AMPLATZER EXCHANGE SYSTEM|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2010|04/22/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P040040|S012|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2010|04/22/2010|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P040003|S007|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2100 SYSTEM|NRZ|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/22/2010|04/19/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020004|S050|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2010|05/12/2010|||APPR|APPROVAL FOR THE REMOVAL OF THE CENTER KNOT SLEEVE ATTACHMENT.
P960013|S057|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|OPTISENSE MODEL 1999 LEAD|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/2010|11/26/2010|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE HEADER COUPLING (FROM A MACHINED COMPONENT TO A MOLDED COMPONENT) OF THE OPTISENSE MODEL 1999 PACING AND SENSING LEAD.
P950020|S039|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|CORONARY FLEXTOME CUTTING BALLOON|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2010|04/06/2010|||OK30|IMPLEMENTATION OF A NEW COATING PROCESS FOR MANDRELS.
P070007|S016|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2010|04/01/2010|||APPR|APPROVAL FOR A CHANGE TO THE STENT GRAFT SPRING ATTACHMENT TENSILE STRENGTH SPECIFICATION.
P070027|S016|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2010|04/01/2010|||APPR|APPROVAL FOR A CHANGE TO THE STENT GRAFT SPRING ATTACHMENT TENSILE STRENGTH SPECIFICATION.
P080011|S003|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTEND WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2010|04/07/2010|||OK30|ADDITION OF A NEW QUALIFIED VENDOR OF THE RAW MATERIAL FOR THE DEVICE.
P020045|S029|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CRYOCONSOLE SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2010|10/29/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC CRYOCATH LP IN POINT CLAIRE, QUEBEC FOR WAREHOUSING AND PERFORMING INCOMING INSPECTIONS.
P030009|S041|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2010|05/13/2010|||OK30|ADDITION OF PROCESS EQUIPMENT.
P010047|S002|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2010|04/15/2010|||OK30|CHANGE FROM A MANUAL MANUFACTURING PROCESS TO AUTOMATED PROCESS FOR FILLING A COMPONENT.
P070014|S011|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2010|04/13/2010|||OK30|ADDITION OF ALTERNATE TENSILE STRENGTH TESTING EQUIPMENT.
P010012|S238|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS PULSE GENERATORS MODELS N118 & N119|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2010|04/15/2010|||OK30|SECOND SOURCE SUPPLIER FOR CONNECTOR BLOCKS.
P960040|S219|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN PULSE GENERATORS MODELS E110|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2010|04/15/2010|||OK30|SECOND SOURCE SUPPLIER FOR CONNECTOR BLOCKS.
P790017|S106|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2010|10/19/2010|||APPR|APPROVAL FOR THE ADDITION OF A NEW ULTRAVIOLET CURING MACHINE.
P030009|S042|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRODRIVER CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2010|10/19/2010|||APPR|APPROVAL FOR THE ADDITION OF A NEW ULTRAVIOLET CURING MACHINE.
P060033|S051|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2010|10/19/2010|||APPR|APPROVAL FOR THE ADDITION OF A NEW ULTRAVIOLET CURING MACHINE.
P990071|S011|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|COOLFLOW TUBING IFU|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/17/2010|04/07/2010|||APPR|APPROVAL FOR CHANGES IN THE LABELING MADE TO THE COOLFLOW IRRIGATION PUMP¿S TUBING SET.
P970008|S049|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2010|05/13/2010|||APPR|APPROVAL TO REPLACE AN OBSOLETE TOUCHSCREEN AND MODIFY THE MICROWAVE GENERATOR TO IMPROVE DESIGN MARGINS.
N18286|S019|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/17/2010|04/08/2010|||APPR|APPROVAL TO ADD A STATEMENT IN THE CONTRAINDICATIONS SECTION OF THE LABELING TO ADDRESS THE POTENTIAL RISK IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.
P010012|S239|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS/LIVIAN/RENEWAL 3 FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2010|04/15/2010|||OK30|CHANGES TO THE HYBRID CLEANING PROCESS TO ALIGN WITH OTHER PRODUCT LINES.
P960040|S220|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK (CONFIENT/TELIGEN/VITALITY)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2010|04/15/2010|||OK30|CHANGES TO THE HYBRID CLEANING PROCESS TO ALIGN WITH OTHER PRODUCT LINES.
P000025|S046|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2010|09/03/2010|||APPR|APPROVAL FOR A CHANGE IN MED-EL¿S SUPPLIER OF A CRITICAL COMPONENT WITH DIRECT IMPACT ON THE SAFETY AND EFFICACY OF THE SONATA IMPLANTS.
P060002|S010|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2010|09/15/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE PROCEDURES FOR IMPLEMENTING SHELF LIVES OF RAW MATERIALS.
P060002|S011|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2010|04/16/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE TO INCLUDE LANGUAGE TO IMPROVE THE SAFETY IN USE OF THE DEVICE, PREDOMINANTLY WITH RESPECT TO THE POTENTIAL FOR DEVICE MIGRATIONS.
P070014|S012|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2010|09/15/2010|||APPR|APPROVAL FOR MODIFICATION TO THE PROCEDURES FOR IMPLEMENTING SHELF LIVES OF RAW MATERIALS.
P080007|S003|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|E-LUMINEXX VASCULAR STENT|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2010|09/15/2010|||APPR|APPROVAL FOR MODIFICATION TO THE PROCEDURES FOR IMPLEMENTING SHELF LIVES OF RAW MATERIALS.
P970029|S017|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2010|04/15/2010|||APPR|APPROVAL FOR MODIFICATION OF AN EXISTING WARNING STATEMENT TO STATE: ¿EACH HANDPIECE DELIVERY SYTEM IS SUPPLIED STERILE FOR SINGLE USE ONLY.  DO NOT REUSE OR RESTERILIZE.  ANY ATTEMPT TO CLEAN AND RESTERILIZE CAN DAMAGE THE FIBEROPTIC.¿
P970008|S050|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2010|04/15/2010|||OK30|CHANGE IN THE COOLING BALLOON BONDING PROCESS.
P860004|S123|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INTRATHECAL CATHETER MODELS 8731SC AND 8598A|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2010|07/29/2011|||APPR|APPROVAL FOR THE CHANGES TO THE GUIDEWIRE ACCESSORY FOR INTRATHECAL CATHETER MODELS 8731SC AND 8598A.
P060008|S047|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2010|05/17/2010|||APPR|APPROVAL FOR MR COMPATIBILITY LABELING CHANGES TO THE DIRECTIONS FOR USE (DFU) AND PATIENT INFORMATION GUIDE (PG) FOR THE TAXUS LIBERTÉ MONORAIL (MR) AND OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS.
P840001|S149|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3 FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2010|04/16/2010|||OK30|IMPLEMENTATION OF THE QUALITYHOLD BUSINESS RULE WITHIN THE FACTORY WORKS MANUFACTURING TRACEABILITY SYSTEM.
P970004|S083|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD& KIT|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2010|04/16/2010|||OK30|IMPLEMENTATION OF THE QUALITYHOLD BUSINESS RULE WITHIN THE FACTORY WORKS MANUFACTURING TRACEABILITY SYSTEM.
P860004|S124|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED FAMILY OF IMPLANTABLE FUSION PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2010|04/16/2010|||OK30|IMPLEMENTATION OF THE QUALITYHOLD BUSINESS RULE WITHIN THE FACTORY WORKS MANUFACTURING TRACEABILITY SYSTEM.
P990034|S017|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED INFUSION PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2010|04/16/2010|||OK30|IMPLEMENTATION OF THE QUALITYHOLD BUSINESS RULE WITHIN THE FACTORY WORKS MANUFACTURING TRACEABILITY SYSTEM.
P010001|S005|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2010|07/06/2010|||APPR|APPROVAL FOR THE ADDITION OF A SECOND MANUFACTURING LINE AT THE MARKTREDWITZ, GERMANY FACILITY.
P790017|S107|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|SPRINTER LEGEND RX BALLOON DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2010|04/21/2010|||OK30|ADDITIONAL VENDOR FOR A COMPONENT OF THE DEVICE.
P860019|S253|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK 2 MONORAIL PTCA CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2010|04/22/2010|||OK30|ALTERNATE MANUFACTURING PROCESS FLOW FOR THE DEVICE.
P070014|S013|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2010|09/14/2010|||APPR|APPROVAL FOR A MODIFICATION TO A STEP IN THE HANDLE ASSEMBLY PROCESS.
P950037|S079|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|RELIATY/MODEL 3145 PACING SYSTEM ANALYZER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2010|09/02/2010|||APPR|APPROVAL FOR A STAND-ALONE VERSION OF THE PACING SYSTEM ANALYZER FUNCTION FOUND IN THE ICS 3000 IMPLANT CONTROL SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RELIATY BY BIOTRONIK, INC. AND MODEL 3145 BY BOSTON SCIENTIFIC AND IS INDICATED FOR USE IN PACING LEAD SYSTEM ANALYSIS DURING THE IMPLANTATION OF PACEMAKERS AND DEFIBRILLATORS.
P980049|S055|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ISOLINE 2CR AND ISOLINE 2CT LEADS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2010|04/22/2010|||OK30|CHANGE IN INCOMING INSPECTION PROCEDURE.
P810046|S236|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||STENT, CORONARY|SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2010|04/23/2010|||OK30|REQUESTED A CHANGE IN MANUFACTURING EQUIPMENT USED TO COAT THE STENT DELIVERY SYSTEM AND BALLOON DILATATION CATHETERS.
P960013|S058|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|OPTISENSE 1999 LEAD|NVN|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2010|05/19/2010|||APPR|APPROVAL FOR NEW STYLETS TO BE INCLUDED IN THE OPTISENSE MODEL 1999 LEAD PACKAGE.
P970020|S055|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ZETA CORONARY STENT SYSTEMS (CSS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2010|04/23/2010|||OK30|REQUESTED A CHANGE IN MANUFACTURING EQUIPMENT USED TO COAT THE STENT DELIVERY SYSTEM AND BALLOON DILATATION CATHETERS.
P020047|S018|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS VISION/MINI VISION|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2010|04/23/2010|||OK30|REQUESTED A CHANGE IN MANUFACTURING EQUIPMENT USED TO COAT THE STENT DELIVERY SYSTEM AND BALLOON DILATATION CATHETERS.
P070015|S033|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2010|04/23/2010|||OK30|REQUESTED A CHANGE IN MANUFACTURING EQUIPMENT USED TO COAT THE STENT DELIVERY SYSTEM AND BALLOON DILATATION CATHETERS.
P910077|S104|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 3120 ZOOM LATITUDE PROGRAMMER|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2010|05/19/2010|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE MODEL 3120 ZOOM LATITUDE PROGRAMMER AND AN ALTERNATE SUPPLIER FOR THE HARD DRIVE COMPONENT IN THE PROGRAMMER.
P980035|S162|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/RELIA/SENSIA/VERSA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/29/2010|08/04/2010|||APPR|APPROVAL FOR THE MANUFACTURING AND DESIGN CHANGES TO XC177 FAMILY OF THE CERAMIC CAPACITORS.
P000021|S016|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2010|04/26/2010|||OK30|REPLACEMENT OF THE INSULIN SUPPLY USED IN THE ANTIBODY GROWTH MEDIA PRODUCTION PROCESS TO COMPENSATE FOR A SHORTAGE.
P020027|S011|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2010|04/26/2010|||OK30|REPLACEMENT OF THE INSULIN SUPPLY USED IN THE ANTIBODY GROWTH MEDIA PRODUCTION PROCESS TO COMPENSATE FOR A SHORTAGE.
P040002|S027|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEMWITH INTUITRAK DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2010|05/12/2010|||APPR|APPROVAL FOR NEW POWERLINK SYSTEM MODELS, INCLUDING BIFURCATED DEVICES WITH NEW LENGTHS AND DIAMETERS, LIMB EXTENSIONS WITH NEW LENGTHS, AND AORTIC EXTENSIONS WITH NEW LENGTHS.
P060040|S007|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/2010|04/06/2010|||APPR|APPROVAL FOR A REPAIR KIT (HM II PLRK) FOR THE EXTERNAL PORTION OF THE HEARTMATE II PERCUTANEOUS LEAD AND A REPAIR KIT (CLAM SHELL) FOR THE EXTERNAL BEND RELIEF.
P000053|S028|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2010|04/23/2010|||OK30|MODIFICATION OF A PARAMETER IN A RECEIVING INSPECTION TEST FOR SILICONE USED IN THE COATING PROCESS.
P010020|S015|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2010|04/23/2010|||OK30|MODIFICATION OF A PARAMETER IN A RECEIVING INSPECTION TEST FOR SILICONE USED IN THE COATING PROCESS.
P030054|S147|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2010|04/23/2010|||OK30|CHANGE IN AUTOMATED MANUFACTURING TESTS.
P910023|S231|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2010|04/23/2010|||OK30|CHANGE IN AUTOMATED MANUFACTURING TESTS.
P880086|S186|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2010|04/23/2010|||OK30|CHANGE IN AUTOMATED MANUFACTURING TESTS.
P030035|S067|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2010|04/23/2010|||OK30|CHANGE IN AUTOMATED MANUFACTURING TESTS.
P040044|S029|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDING A MANUFACTURING PROCESS FOR THE ADVANCER TUBE COMPONENT IN-HOUSE.
P030017|S102|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/29/2010|07/19/2010|||APPR|APPROVAL FOR THE INTRODUCTION OF A NEW CHARGER BELT AND OPTIONAL SPACER.
P030017|S103|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|USE OF A REWORK PROCESS WITHIN THE PRODUCTION PROCESS TO INCREASE PRODUCT YIELD.
P060001|S008|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||APPR|APPROVAL FOR THE ADDITION OF A NEW MATERIAL SPECIFICATION AND AN INCOMING INSPECTION STEP FOR THE ANNEALED TANTALUM SPHERE COMPONENTS OF THE DEVICE.
P980016|S233|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P010015|S083|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN/INSYNC/INSYNC III|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P010031|S192|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/INSYNC II/MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P030036|S016|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P080006|S007|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P830061|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/VITATRON CRYSTALINE/EXCELLENCE+/EXCELLENCE PS+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P850089|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/CAPSURE Z NOVUS/STERX TIP PACING LEAD (VENTRICULAR)/VITATRON EXCELLENCE S+/EXCELLENCE SS+/IMPULSE/IMPULSE II|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P890003|S187|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE/CAPSURE MODEL/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P900061|S088|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P920015|S059|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/FIDELIS/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q DEFIBRILLAION LEAD/TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P930039|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P950024|S020|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P970012|S066|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P980035|S163|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 600/700/800/900/RELIA/SENSIA/VERSA/SIGMA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P980050|S048|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P990001|S065|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P060039|S011|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2010|04/28/2010|||OK30|ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.
P020030|S006|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|SITUS OTW UW28D LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2010|04/29/2010|||OK30|CHANGE IN LASER WELDING ENERGY MONITORING.
P060027|S022|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SITUS OTW UW28D LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2010|04/29/2010|||OK30|CHANGE IN LASER WELDING ENERGY MONITORING.
P010031|S193|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO 2 CRT-D D284TRK, CONCERTO 2 D274TRK IMPLANTSBLE CARDIOVERTER DEFIBRILLATORS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/31/2010|05/11/2010|||APPR|APPROVAL FOR UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS.
P020011|S003|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2010|04/23/2010|||OK30|CHANGE OF LOCATION FOR A QC LAB TO SEGREGATE THE PRE- AND POST-AMPLIFICATION STEPS INTO SEPARATE ROOMS.
P980016|S234|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SECURA DR/VR D224DRG/ D224VRC, MAXIMO DR/VR D284DRG/ D284VRC, VIRTUOSO II DR/VR D274DRG/ D274VRC|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/31/2010|05/11/2010|||APPR|APPROVAL FOR UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS.
P940034|S018|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST|MWA|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2010|04/23/2010|||OK30|CHANGE OF LOCATION FOR A QC LAB TO SEGREGATE THE PRE- AND POST-AMPLIFICATION STEPS INTO SEPARATE ROOMS.
P890003|S188|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA)|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/31/2010|05/11/2010|||APPR|APPROVAL FOR UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS.
P980035|S164|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG/ADAPTA/VERSA/SENIA IPG/RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2010|04/30/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLANTING PROCESS.
P870078|S008|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK APICAL LEFT VENTRICLE CONNECTOR|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2010|09/20/2010|||APPR|APPROVAL FOR THE HANCOCK APICAL LEFT VENTRICLE CONNECTOR, MODEL 174A. THE DEVICE IS INDICATED FOR PROVIDING AN ALTERNATIVE METHOD FOR RELIEF OF LEFT VENTRICULARHYPERTENSION IN PATIENTS WITH SEVERE LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION DUE TO HYPOPLASIA OFTHE AORTIC ROOT, HYPOPLASIA OF THE AORTIC ANNULUS, OR ACQUIRED PROBLEMS SECONDARY TO AORTIC VALVE REPLACEMENT WHICH CANNOT BE RELIEVED THROUGH CONVENTIONAL TECHNIQUES.
P010031|S194|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2010|04/30/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLANTING PROCESS.
P980016|S235|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VIRTUOSO/VIRTUOSO II VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2010|04/30/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLANTING PROCESS.
P010015|S084|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA & SYNCRA CRT-PS IMPLANTABLE PULSE GENERATOR WITH CARDIAC RESYNCHRONIZATION|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2010|03/22/2011|||APPR|APPROVAL FOR THE CONSULTA CRT-P C4TR01 AND SYNCRA CRT-P C2TR01 IMPLANTABLE PULSE GENERATORS WITH CARDIAC RESYNCHRONIZATION, SOFTWARE MODEL 9995 (VERSION 7.3), CARELINK MONITOR MODELS 2490G AND MODEL 2491 DDMA.
P890003|S189|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CARELINK MONITOR MODELS 2490G/2491DDMA|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/31/2010|03/22/2011|||APPR|APPROVAL FOR THE CONSULTA CRT-P C4TR01 AND SYNCRA CRT-P C2TR01 IMPLANTABLE PULSE GENERATORS WITH CARDIAC RESYNCHRONIZATION, SOFTWARE MODEL 9995 (VERSION 7.3), CARELINK MONITOR MODELS 2490G AND MODEL 2491 DDMA.
P040044|S030|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2010|04/30/2010|||OK30|MOVING POST-STERILE ACTIVITIES ASSOCIATED WITH PRODUCT HANDLING, STORAGE AND SHIPPING FROM ONE FACILITY TO ANOTHER FACILITY ON THE SAME STREET.
P080010|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) MODEL ZMA00|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2010|04/28/2010|||OK30|CHANGE FROM MANUAL TO AUTOMATED ROTATION DURING THE HOLE-DRILLING STEP.
P990020|S039|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2010|05/21/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD., IN OFFALY, IRELAND.
P980007|S010|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA ASSAY|MTG|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/2010|08/31/2010|||APPR|APPROVAL FOR INCORPORATING ADDITIONAL SPECIFIC PERFORMANCE CHARACTERISTIC INFORMATION IN REFERENCE TO PRECISION, LIMIT OF BLANK (LOB), LIMIT OF DETECTION (LOD), LIMIT OF QUANTITATION (LOQ), LINEARITY AND MEASURING INTERVAL IN THE PRODUCT LABELING FOR THE ARCHITECT FREE PSA ASSAY.
P910007|S018|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ABBOTT ARCHITECT TOTAL PSA ASSAY|MTF|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/2010|08/31/2010|||APPR|APPROVAL FOR INCORPORATING ADDITIONAL SPECIFIC PERFORMANCE CHARACTERISTIC INFORMATION IN REFERENCE TO PRECISION, LIMIT OF BLANK (LOB), LIMIT OF DETECTION (LOD), LIMIT OF QUANTITATION (LOQ), LINEARITY AND MEASURING INTERVAL IN THE PRODUCT LABELING FOR THE ARCHITECT TOTAL PSA ASSAY.
P810046|S237|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|VOYAGER NC CORONARY DILATATION CATHETER|LOX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/02/2010|06/01/2010|||APPR|APPROVAL FOR A CHANGE IN THE IN-PROCESS EXTRUDED BALLOON TUBING OUTER DIAMETER.
P040044|S031|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2010|05/04/2010|||OK30|CHANGE TO A COMPONENT JOINING PROCESS.
N18033|S046|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2010|04/30/2010|||OK30|ALTERNATE SUPPLER FOR THE FOIL LIDSTOCK MATERIAL.
P040045|S013|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACTS LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2010|04/30/2010|||OK30|ADDITION OF A NEW SUPPLIER FOR SOIL LIDDING MATERIAL.
P840001|S150|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2010|04/30/2010|||OK30|ADDITION OF A SUPPLIER FOR THE PLANTING PROCESS.
P960009|S079|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2010|04/30/2010|||OK30|ADDITION OF A SUPPLIER FOR THE PLANTING PROCESS.
P970004|S084|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2010|04/30/2010|||OK30|ADDITION OF A SUPPLIER FOR THE PLANTING PROCESS.
P060040|S008|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE2 LVAS|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2010|09/30/2010|||APPR|APPROVAL FOR A SEALED INFLOW CONDUIT.
P970018|S021|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM|MKQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|04/05/2010|06/30/2010|||APPR|APPROVAL FOR CHANGES MADE TO THE PREPSTAIN SOFTWARE TO REFLECT CUSTOMER PREFERENCE FOR ¿PREP ONLY¿ PROCESSING.
P960043|S071|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE AT 6F SUTURE-MEDIATED CLOSURE SYSTEM & THE PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2010|05/05/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR TWO OVERMOLDED COMPONENTS.
P060040|S009|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/05/2010|04/30/2010|||APPR|APPROVAL FOR PROVIDING ADDITIONAL INFORMATION IN THE LABELING REGARDING THE PROPER PROCEDURE FOR MAKING CONNECTIONS BETWEEN THE ELECTRICAL POWER CABLES OF TE DEVICE.
P060037|S012|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|FLEX MOBILE BEARING KNEE|NJL|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2010|01/31/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZIMMER ORTHOPEDIC MFG LTD. (AOLM), IN SHANNON INDUSTRIAL ESTATE, IRELAND AND A STERILIZATION SITE LOCATED AT ISOTRON, WESTPORT, IRELAND.
P030049|S008|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2010|04/20/2010|||OK30|CHANGE OF RAW MATERIAL USED IN THE PRODUCTION OF THE LITE REAGENT BUFFER.
P000006|S019|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2010|05/06/2010|||OK30|USE OF AN AUTOMATED PIECE OF EQUIPMENT IN DIPPING LARGE SIZE TITAN CYLINDERS.
P000057|S006|INTEGRA LIFESCIENCES CORPORATION|8900 CAMERON ROAD||AUSTIN|TX|78754||Finger semi-constrained pyrolytic carbon uncemented prosthesis|ASCENSION ORTHOPEDICS MCP|NEG|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2010|08/26/2011|||APPR|APPROVAL FOR A CHANGE TO THE COATING SUPPLIER MANUFACTURING FACILITY.
P070007|S017|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/2010|04/30/2010|||APPR|APPROVAL FOR LABELING CHANGES REGARDING OVER SIZING BEYOND CURRENT RECOMMENDATIONS AND THE PLACEMENT OF BARE SPRINGS INSIDE OF COVERED STENT GRAFTS.
P960058|S084|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2010|08/20/2010|||APPR|APPROVAL TO UPDATE THE MANUFACTURING SPECIFICATION FOR THE FINAL MOLD PROCESS OF THE COIL-CASE/ELECTRODE SUBASSEMBLY TO REPLACE MANUAL SILICONE INJECTION WITH AN AUTOMATED DISPENSING MECHANISM.
P040002|S028|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|05/13/2010|||OK30|CHANGE TO THE HEMOSTASIS HANDLE ASSEMBLY OF THE DEVICE.
P020009|S062|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P030025|S087|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P040016|S055|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P050019|S005|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P060006|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P060008|S048|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P930031|S028|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P940019|S023|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P980033|S017|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P950020|S040|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|FLEXTOME CUTTING BALLOON|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
P020004|S051|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2010|04/14/2010|||OK30|MODIFICATION TO DEPLOYMENT FORCE AND TENSILE STRENGTH SPECIFICATIONS FOR THE DEVICE COMPONENTS.
P990037|S030|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2010|05/07/2010|||OK30|CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS FROM AN IN-HOUSE MANUFACTURED STERILIZATION PROCESS CONTROL DEVICE (SPCD) TO A COMMERCIALLY PURCHASED PCD.
P090018|S001|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/2010|05/06/2011|||APPR|APPROVAL FOR THE LEAD DESIGN (MODEL 7004/7504 LEADS) AND LEAD MANUFACTURING SITE CHANGE (ENVOY MEDICAL CORP., ST. PAUL, MINNESOTA).
P980035|S165|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2010|05/12/2010|||OK30|ADDITIONAL SUPPLIER FOR THE PLATING PROCESS.
P980016|S236|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/VIRTUOSO/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2010|05/12/2010|||OK30|ADDITIONAL SUPPLIER FOR THE PLATING PROCESS.
P010031|S195|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2010|05/12/2010|||OK30|ADDITIONAL SUPPLIER FOR THE PLATING PROCESS.
P990001|S066|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DIVA PLATFORM IMPLANTABLE PULSE GENERATORS & PRO VIT APPLICATION SOFTWARE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2010|05/12/2010|||OK30|ADDITIONAL SUPPLIER FOR THE PLATING PROCESS.
P960009|S080|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA PARKINSON¿S CONTROL THERAPY|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/2010|04/30/2010|||APPR|APPROVAL FOR ADDING A WARNING TO BOTH THE PHYSICIAN AND PATIENT MANUALS.
P980023|S040|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2010|05/13/2010|||OK30|CHANGE IN PACKAGING TO THE INNER AND OUTER BAGS OF THE STERILIZED STYLET ACCESSORIES.
P950037|S080|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2010|05/13/2010|||OK30|CHANGE IN PACKAGING TO THE INNER AND OUTER BAGS OF THE STERILIZED STYLET ACCESSORIES.
P050023|S030|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS AND CRT-DS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2010|05/13/2010|||OK30|CHANGE IN PACKAGING TO THE INNER AND OUTER BAGS OF THE STERILIZED STYLET ACCESSORIES.
P070014|S014|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track|Postapproval Study Protocol - OSB|N|04/13/2010|10/18/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P810031|S037|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2010|05/20/2010|||APPR|APPROVAL FOR A CHANGE IN PACKAGING FOR TWO INDIVIDUAL BLISTER TRAY PACKS (HEALON & HEALON5) TO BE PACKED IN A SINGLE CARTON BOX.
P960013|S059|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2010|05/13/2010|||OK30|CHANGE IN MCRD MANUFACTURING PROCESS.
P960030|S030|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS, ISOFLEX S & P, AND ISOFLEX OPTIM LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2010|05/13/2010|||OK30|CHANGE IN MCRD MANUFACTURING PROCESS.
P810046|S238|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|VOYAGER NC CORONARY DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2010|05/13/2010|||OK30|CHANGE IN THE EXTRUSION PROCESS FOR THE TUBING USED TO MANUFACTURE THE VOYAGER® NC CORONARY DILATATION CATHETER¿S 3.50 MM THROUGH 5.00 MM BALLOONS.
P050009|S009|Biomet, Inc.|P.O. Box 587||Warsaw|IN|46581|0587|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|C2A-TAPER ACETABULAR HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/16/2010|02/11/2011|||APPR|APPROVAL TO SUSPEND THE POST APPROVAL STUDY BASED ON SUSPENSION OF MARKETING AND SALES IN THE US.
P890003|S190|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODEL 2090 & 2090X CARELINK PROGRAMMER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/14/2010|||OK30|CHANGE TO THE ANTENNA SUPPORT, MANUFACTURING PROCESS CHANGES RELATED TO THE ANTENNA SUPPORT CHANGE, AND CHANGES TO AN ANTENNA TEST.
P010012|S240|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN/RENEWAL 3/RENEWAL 3RF/RENEWAL 3 AVT PULSE GENERATOR FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/19/2010|||OK30|PLATING CHANGE TO THE REED SWITCH COMPONENT.
P960040|S221|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT AND VITALITY HE FAMILIES OF PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/19/2010|||OK30|PLATING CHANGE TO THE REED SWITCH COMPONENT.
P840001|S151|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|06/17/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS.
P960009|S081|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|06/17/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS.
P030025|S088|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|REPLACEMENT OF THE FINAL INSPECTION CAMERA WITH ONE THAT PERFORMS THE EXISTING CATHETER FINAL INSPECTION PROCESS AT THE SDS FINAL INSPECTION STATION.
P060008|S049|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|REPLACEMENT OF THE FINAL INSPECTION CAMERA WITH ONE THAT PERFORMS THE EXISTING CATHETER FINAL INSPECTION PROCESS AT THE SDS FINAL INSPECTION STATION.
P030025|S089|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|CHANGES TO PROCESS SOFTWARE.
P060008|S050|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|CHANGES TO PROCESS SOFTWARE.
P890064|S022|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/17/2010|||OK30|CHANGE IN SUPPLIER FOR THE REAGENT IN THE DEVICE.
P890064|S023|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/17/2010|||OK30|ENABLING THE EXISTING BARCODE READER CONFIGURATION WITHIN THE EQUIPMENT SOFTWARE DURING THE PRODUCTION OF THE DEVICE.
P890064|S024|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/17/2010|||OK30|SCALE-UP IN THE PRODUCTION OF A COMPONENT IN THE DEVICE.
P030025|S090|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|CHANGE TO THE SOFTWARE USED DURING A STEP IN THE STENT MANUFACTURING PROCESS.
P020009|S063|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|CHANGE TO THE SOFTWARE USED DURING A STEP IN THE STENT MANUFACTURING PROCESS.
P060008|S051|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|CHANGE TO THE SOFTWARE USED DURING A STEP IN THE STENT MANUFACTURING PROCESS.
P040016|S056|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|CHANGE TO THE SOFTWARE USED DURING A STEP IN THE STENT MANUFACTURING PROCESS.
P060006|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|CHANGE TO THE SOFTWARE USED DURING A STEP IN THE STENT MANUFACTURING PROCESS.
P090003|S001|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2010|05/13/2010|||OK30|CHANGE TO THE SOFTWARE USED DURING A STEP IN THE STENT MANUFACTURING PROCESS.
P960040|S222|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK PRIZM, VENTAK PRIZM 2, VITALITY, VITALITY HE, VITALITY 2, VITALITY AVT, AND CONFIENT FAMILIES OF ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2010|05/19/2010|||OK30|MULTIPLE CLEANING AND COMPONENT TESTING CHANGES FOR THE CRYSTAL OSCILLATOR COMPONENT.
P010012|S241|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF, CONTAK RENEWAL 3 RF HE, LIVIAN SE, LIVIAN HE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2010|05/19/2010|||OK30|MULTIPLE CLEANING AND COMPONENT TESTING CHANGES FOR THE CRYSTAL OSCILLATOR COMPONENT.
P030005|S063|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2010|05/19/2010|||OK30|MULTIPLE CLEANING AND COMPONENT TESTING CHANGES FOR THE CRYSTAL OSCILLATOR COMPONENT.
P060008|S052|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2010|05/13/2010|||OK30|CHANGE FROM A MANUAL IN-PROCESS INSPECTION TO AN AUTOMATED IN-PROCESS INSPECTION.
P040016|S057|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2010|05/13/2010|||OK30|CHANGE FROM A MANUAL IN-PROCESS INSPECTION TO AN AUTOMATED IN-PROCESS INSPECTION.
P010012|S242|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 AND LIVIAN FAMILIES OF CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2010|05/20/2010|||OK30|CHANGES IN THE SUPPLIERS FOR THIN-FILM RESISTORS.
P960040|S223|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT AND VITALITY FAMILIES OF ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2010|05/20/2010|||OK30|CHANGES IN THE SUPPLIERS FOR THIN-FILM RESISTORS.
P970003|S109|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/19/2010|05/18/2010|||APPR|APPROVAL FOR A LABELING MODIFICATION REGARDING THE INTERNAL CLOCK RESET IN THE MODEL 100, 101, 102 AND 102R IMPLANTED PULSE GENERATORS (IPGS).
P830061|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE/VITATRON|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2010|05/19/2010|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER OF ELECTRODE COMPONENTS.
P860004|S125|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2010|05/02/2012|||APPR|APPROVAL FOR THE SUBJECT ASCENDA  CATHETER, WHICHCONSIST OF TWO MODELS (8780 AND 8781) (HAT ARE IDENTICAL IN COMPONENTS AND ACCESSORIES AND DIFFER ONLY IN THEIR TOTAL LENGTH. THIS CATHETER DIFFERS FROM THE CURRENT INTRATHECAL CATHETERS USED WITH MEDTRONIC IMPLANTABLE PUMPS BY THE FOLLOWING MODIFICATIONS: 1)  MULTI-LAYERED CATHETER BODY THAT RESISTS CUTS, FRACTURES, AND OCCLUSIONS; 2) BI-WING ANCHOR WITH NEW ANCHOR DISPENSER DESIGNED TO PREVENT CATHETER DISLODGMENT; 3) CATHETER CONNECTOR THAT PREVENTS PUNCTURE OF THE CATHETER BODY; AND 4) MODIFIED SUTURELESS PUMP CONNECTOR DESIGN TO PREVENT OCCLUSION.
P930039|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS/VITATRON|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2010|05/19/2010|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER OF ELECTRODE COMPONENTS.
P070015|S034|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/14/2010|||OK30|CHANGE TO THE BALLOON MANUFACTURING PROCESS.
P010047|S003|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/25/2010|||OK30|MODIFICATION OF A TEST PROCEDURE USED TO DETERMINE THE PERCENT PROTEIN OF HUMAN SERUM ALBUMIN IN THE COMPONENT MANUFACTURING PROCESS AND FOR FINAL RELEASE.
P860004|S126|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/2010|10/06/2010|||APPR|APPROVAL FOR LABELING CHANGES TO THE SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS TO SPECIFICALLY REFERENCE INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION) IN THE TREATMENT OF CHRONIC INTRACTABLE PAIN, AND PRIALT (PRESERVATIVE-FREEZICONOTIDE STERILE SOLUTION) FOR THE MANAGEMENT OF SEVERE CHRONIC PAIN, IDENTIFY THE MAXIMUM CONCENTRATION FOR INFUMORPH, PRIALT AND LIORESAL THAT CAN BE DELIVERED.
P990034|S018|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED IMPLANTABLE INFUSION SYSTEMS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/2010|10/06/2010|||APPR|APPROVAL TO: 1) UPDATE THE LABELING FOR THESE DEVICES TO SPECIFICALLY REFERENCE INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION) IN THE TREATMENT OF CHRONIC INTRACTABLE PAIN; AND 2) TO ADD LANGUAGE TO IDENTIFY THE MAXIMUM CONCENTRATION FOR INFUMORPH THAT CAN BE DELIVERED THROUGH THE ISOMED IMPLANTABLE  INFUSION SYSTEMS.
P840001|S152|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/20/2010|||OK30|ADDITION OF THE SUPPLEMENTAL AUTOMATED OPTICAL INSPECTION (AOI).
P960009|S082|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF IMPLANTABLE STIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/20/2010|||OK30|ADDITION OF THE SUPPLEMENTAL AUTOMATED OPTICAL INSPECTION (AOI).
P970004|S085|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM ICON PATIENT PROGRAMMER|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/20/2010|||OK30|ADDITION OF THE SUPPLEMENTAL AUTOMATED OPTICAL INSPECTION (AOI).
P860004|S127|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PERSONAL THERAPY MANAGER (MYPTM)|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/20/2010|||OK30|ADDITION OF THE SUPPLEMENTAL AUTOMATED OPTICAL INSPECTION (AOI).
P030005|S064|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/20/2010|||OK30|ELIMINATION OF THE OUTER SLEEVE WASH STEP.
P940031|S067|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DUAL-CHAMBER ADAPTIVE-RATE PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/20/2010|||OK30|ELIMINATION OF THE OUTER SLEEVE WASH STEP.
P010012|S243|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2010|05/20/2010|||OK30|ELIMINATION OF THE OUTER SLEEVE WASH STEP.
P040005|S005|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 FISH PHARMDX KIT|MVD|PA|Panel Track||N|04/20/2010|10/20/2010|10M-0558|11/18/2010|APPR|APPROVAL FOR THE HER2 FISH PHARMDX KIT.  THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE.  THE HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA.  HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT).
P000039|S036|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2010|05/28/2010|||OK30|CHANGE IN THE SUPPLIER OF THE STITCHING YARN USED IN SELECT NITINOL OCCLUSION DEVICES.
P020024|S029|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2010|05/28/2010|||OK30|CHANGE IN THE SUPPLIER OF THE STITCHING YARN USED IN SELECT NITINOL OCCLUSION DEVICES.
P040040|S013|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2010|05/28/2010|||OK30|CHANGE IN THE SUPPLIER OF THE STITCHING YARN USED IN SELECT NITINOL OCCLUSION DEVICES.
P010001|S006|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2010|09/15/2010|||APPR|APPROVAL FOR THE ADDITION OF A SECOND IDENTICAL LINE OF GRINDING, POLISHING, AND CLEANING PROCESSES AT THE PLOCHINGEN, GERMANY FACILITY.
P010001|S007|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2010|09/15/2010|||APPR|APPROVAL FOR THE REPLACEMENT OF TWO GRINDING MACHINES AND ADDITION OF ONE PIECE OF PROOF TESTING EQUIPMENT AT THE PLOCHINGEN, GERMANY FACILITY AND ADDITION OF A GRINDING MACHINE AND PIECE OF PROOF TESTING EQUIPMENT AT THE MARKTREDWITZ, GERMANY FACILITY.
P980018|S010|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|Panel Track|Change Design/Components/Specifications/Material|N|04/21/2010|10/20/2010|10M-0557|11/17/2010|APPR|APPROVAL FOR THE HERCEPTEST KIT.  THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE.  HERCEPTEST IS A SEMI-QUANTITATIVE IMMUNOCYTOCHEMI-CAL ASSAY TO DETERMINE HER2 PROTEIN OVEREXPRESSION IN BREAST CANCER TISSUES ROUTINELY PROCESSED FOR HISTOLOGICAL EVALUATION AND FORMALIN-FIXED, PARAFFIN-EMBEDDED CANCER TISSUE FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA.  HERCEPTEST IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT).
P030031|S029|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2010|05/27/2010|||OK30|ADDITION OF SECOND SOURCE SUPPLIER OF THE PEBAX 40D TUBING.
P040036|S022|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT THERMOCOOL CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2010|05/27/2010|||OK30|ADDITION OF SECOND SOURCE SUPPLIER OF THE PEBAX 40D TUBING.
P950022|S069|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|DURATA FAMILY OF LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2010|01/24/2011|||APPR|APPROVAL FOR 1) DESIGN MODIFICATIONS TO THE SUTURE SLEEVE OF ALL COMMERCIALLY AVAILABLE DURATA LEADS; 2) 7F SUTURE SLEEVE ACCESSORY KIT COMPATIBLE WITH ALL SJM 7F LEADS; 3) REDUCTION IN PVP (FASTPASS) COATING LENGTH FOR ALL DUAL-SHOCK VERSIONS OF COMMERCIALLY AVAILABLE DURATA LEADS; AND 4) DESIGN MODIFICATIONS TO THE IS-1 CONNECTOR CRIMP CONNECTION FOR ALL TRIFURCATED VERSIONS OF THE COMMERCIALLY- AVAILABLE DURATA LEADS.
P980040|S033|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS MULTIFOCAL ONE0PIECE INTRAOCULAR (IOL) MODEL ZMB00|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2010|05/20/2010|||OK30|CHANGE IN THE STERILIZATION CYCLE PARAMETERS FOR THE DEVICE.
P970027|S008|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT AXSYM ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2010|05/13/2010|||OK30|CHANGE TO THE EFFICACY TESTING PERFORMED ON NEW INCOMING LOTS OF CONJUGATE CONCENTRATE FOR THE DEVICE.
P940015|S018|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2010|11/24/2010|||APPR|APPROVAL FOR THE INTRODUCTION OF FEDEGARI AUTOCLAVE AS AN ADDITIONAL AUTOCLAVE IN THE MANUFACTURING PROCESS.
P980022|S071|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLOCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2010|10/20/2011|||APPR|APPROVAL FOR INCORPORATING A USB CONNECTION FOR DATA UPLOAD, CHANGING THE OPERATING TIME BEFORE RECHARGING, CHANGING TO A WEB-BASED SOFTWARE SYSTEM, AND INCORPORATING A DOCKING STATION AND CLEANING PLUG. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM (MMT-7745).
P980016|S237|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENRYTHM IPG|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2010|10/19/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE MEDTRONIC ENRHYTHM PULSE GENERATORS AND ENTRUST (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) PROGRAMMER APPLICATION SOFTWARE MODEL 9987 (VERSION 7.2), MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) (PART OF MODEL 2490G CARELINK MONITOR SYSTEM), FIRMWARE, AND THE POST STERILIZATION MANUFACTURING TEST SOFTWARE.
P980035|S166|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENTRUST ICD FAMILY|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2010|10/19/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE MEDTRONIC ENRHYTHM PULSE GENERATORS AND ENTRUST (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) PROGRAMMER APPLICATION SOFTWARE MODEL 9987 (VERSION 7.2), MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) (PART OF MODEL 2490G CARELINK MONITOR SYSTEM), FIRMWARE, AND THE POST STERILIZATION MANUFACTURING TEST SOFTWARE.
P890003|S191|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK DDMA SOFTWARE AND CARELINK MONITOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2010|10/19/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE MEDTRONIC ENRHYTHM PULSE GENERATORS AND ENTRUST (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) PROGRAMMER APPLICATION SOFTWARE MODEL 9987 (VERSION 7.2), MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) (PART OF MODEL 2490G CARELINK MONITOR SYSTEM), FIRMWARE, AND THE POST STERILIZATION MANUFACTURING TEST SOFTWARE.
P910073|S083|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2010|05/21/2010|||OK30|REPLACEMENT OF EXISTING AUTOMATED MEASURING EQUIPMENT.
P050007|S025|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2010|05/21/2010|||OK30|ADDITION OF A POST-CURE PROCESS TO THE MANUFACTURING OF THE RELEASE ROD COMPONENT.
P010021|S018|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT PACK & CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2010|05/20/2010|||OK30|ADDITION OF A NEW SUPPLIER OF A RAW MATERIAL USED IN THE MANUFACTURE OF THE VITRO ANTI-HCV CALIBRATOR.
P020026|S079|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/26/2010|06/24/2010|||APPR|APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE.
P890023|S017|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|BIOMEDICS UV 55% (OCUFILCON D) SPHERE, ASPHERE & TORIC SOFT CONTACT LENS|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2010|08/09/2011|||APPR|APPROVAL FOR AN ALTERNATE VENDOR, BIMAX, FOR RAW MATERIAL.
P950029|S052|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|SYMPHONY SR 2250 & DR 2550/RHAPSODY SR 2210/DR 2510/2530 & REPLY SR/DR & ESPRIT SR/DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2010|05/26/2010|||OK30|CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING.
P980049|S056|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2010|05/26/2010|||OK30|CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING.
P060027|S023|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT 8750|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2010|05/26/2010|||OK30|CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING.
P910073|S084|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2010|09/28/2010|||APPR|MODIFICATIONS TO INSPECTION CRITERIA FOR A SPECIFIC LEAD COMPONENT.
P860057|S068|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2010|06/24/2010|||APPR|APPROVAL FOR A NEW MITRAL VALVE MODEL TO BE ADDED TO THE CARPENTIER-EDWARDS PERIMOUNT VALVE SERIES, WHICH INCORPORATES A NEW SUTURE GUIDE LINE, A HYBRID CLIP, A MODIFIED JAR, A MODIFIED SLEEVE, A HYBRID HOLDER, AND MODIFIED ACCESSORIES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES, MODELS 7300 & 7300TFX, AND IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC MITRAL VALVE.
P050010|S005|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC L TOTAL REPLACEMENT|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2010|05/26/2010|||OK30|NEW MAHR PERTHOMETER THAT USES A DIFFERENT SOFTWARE VERSION THAN THE EXISTING MAHR PERTHOMETER USED TO MEASURE SURFACE TOUGHNESS.
P050010|S006|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC L TOTAL DISC REPLACEMENT|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2010|05/26/2010|||OK30|UPGRADE OF THE ROFIN BAASEL SOFTWARE, WHICH CONTROLS THE ETCHING MACHINE, FROM VERSION 1.0.54 TO 1.0.61.
P020047|S019|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTILINK VISION & MULTI LINK MINI VISION OTW CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2010|05/21/2010|||OK30|CHANGE TO THE EXTRUSION MANUFACTURING PROCESS.
P070015|S035|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|PROMUS & XIENCE V OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2010|05/21/2010|||OK30|CHANGE TO THE EXTRUSION MANUFACTURING PROCESS.
P840001|S153|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREULTRA IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2010|05/27/2010|||OK30|CHANGE TO QUALIFY A CONNECTOR REWORK PROCESS FOR THE DEVICE MANUFACTURING PROCESSES AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, PUERTO RICO.
P860019|S255|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX PTCA DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2010|05/27/2010|||OK30|ALTERNATE STERILIZATION CYCLE TO BE USED AT ISOTRON, TULLAMORE, IRELAND.
P990066|S036|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2010|05/27/2010|||OK30|CHANGE IN SUPPLIER AND REPLACEMENT OF OBSOLETE COMPUTER SYSTEMS.
P000008|S017|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND|LTI|GU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/27/2010|02/16/2011|12M-1013|09/26/2012|APPR|APPROVAL FOR LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM.  THE LAP-BAND SYSTEM IS INDICATED FOR WEIGHT REDUCTION FOR PATIENTS WITH OBESITY, WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2 OR A BMI OF AT LEAST 30 KG/ M2 WITH ONE OR MORE OBESITY RELATED COMORBID CONDITIONS.  IT IS INDICATED FOR USE IN ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.  PATIENTS WHO ELECT TO HAVE THIS SURGERY MUST MAKE THE COMMITMENT TO ACCEPT SIGNIFICANT CHANGES IN THEIR EATING HABITS FOR THE REST OF THEIR LIVES.
P000025|S047|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2010|09/03/2010|||APPR|APPROVAL FOR A CHANGE IN THE PRODUCTION OF THE THERMOFORMING FOIL USED TO PRODUCE THE BLISTERS OF THE STERILE PACKAGE FOR THE COCHLEAR IMPLANTS.
P980022|S072|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MMT-7002 & MMT-7003 GLUCOSE SENSORS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2010|06/10/2010|||OK30|CHANGE TO GLUCOSE SENSORS AND THE ADDITION OF A NEW VENDOR.
P070015|S036|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/29/2010|05/23/2011|||APPR|APPROVAL FOR UPDATES TO YOUR LABELING TO INCLUDE 1-YEAR RESULTS FROM THE SPIRIT IV TRIAL, A POOLED SPIRIT II-III-IV ANALYSIS, GENDER-SPECIFIC ANALYSES, AND UPDATED RESULTS FROM THE SPIRIT FIRST, II, AND III TRIALS.
P950022|S070|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA FAMILY OF LEADS|NVY|CV|Real-Time Process||N|04/30/2010|06/22/2010|||APPR|APPROVAL FOR A LABELING CHANGE FROM SJ-4 TO DF-4 FOR ST. JUDE MEDICAL HIGH VOLTAGE LEAD, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRODUCTS.
P910023|S232|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT, CURRENT+, CURRENT ACCEL AND FORTIFY CRT-D'S|NVZ|CV|Real-Time Process||N|04/30/2010|06/22/2010|||APPR|APPROVAL FOR A LABELING CHANGE FROM SJ-4 TO DF-4 FOR ST. JUDE MEDICAL HIGH VOLTAGE LEAD, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRODUCTS.
P030054|S148|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, PROMOTE+, PROMOTE ACCEL AND UNIFY CRT-D'S AND LEADS AND MERLIN PROGRAMMER|NIK|CV|Real-Time Process||N|04/30/2010|06/22/2010|||APPR|APPROVAL FOR A LABELING CHANGE FROM SJ-4 TO DF-4 FOR ST. JUDE MEDICAL HIGH VOLTAGE LEAD, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRODUCTS.
P010003|S015|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/2010|05/12/2010|||APPR|APPROVAL FOR CLARIFICATION REGARDING ONE OF THE WARNINGS IN THE INSTRUCTIONS FOR USE (IFU).
P060022|S007|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2010|05/19/2010|||OK30|ELIMINATION OF THE OPHTHALMIC IRRIGATION SOLUTION SPECIFICATION OF THE LENS STORAGE SOLUTION.
P970031|S029|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/955CS/995MS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2010|05/28/2010|||OK30|ADDITION OF GORDITOS MEATS AS AN ALTERNATE SUPPLIER.
P990064|S033|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310/305U|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2010|05/28/2010|||OK30|ADDITION OF GORDITOS MEATS AS AN ALTERNATE SUPPLIER.
P980043|S026|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2010|05/28/2010|||OK30|ADDITION OF GORDITOS MEATS AS AN ALTERNATE SUPPLIER.
P790007|S025|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT MODEL 150|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2010|05/28/2010|||OK30|ADDITION OF GORDITOS MEATS AS AN ALTERNATE SUPPLIER.
P870078|S009|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2010|05/28/2010|||OK30|ADDITION OF GORDITOS MEATS AS AN ALTERNATE SUPPLIER.
P000026|S003|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||Intraocular pressure lowering implant|AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICES|OGO|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2010|06/17/2010|||APPR|APPROVAL FOR A MINOR LABELING CHANGE FOR THE DEVICE.
P960009|S083|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA RC AND PC NEUROSTIMULATORS|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/03/2010|06/28/2010|||APPR|APPROVAL FOR MINOR FIRMWARE DESIGN CHANGES TO AUTOMATE THE HANDLING OF MOST POR (POWER ON RESET) EVENTS IN THE ¿ACTIVA RC AND ACTIVA PC NEUROSTIMULATOR.
P040012|S032|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|11/08/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE STENT LASER MANUFACTURING PROCESS.
P060030|S010|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice||N|05/03/2010|06/15/2010|||OK30|CHANGE TO THE MANUFACTURE OF BULK MAGNETIC GLASS PARTICLES TO ALLOW USE OF A SECOND SINTERING OVEN.
P070027|S017|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|THE TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/18/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC IRELAND, GALWAY, IRELAND, FOR FINAL ASSEMBLY PROCESSES AND FOR ISOTRON IRELAND, LTD., TULLAMORE, IRELAND, FOR STERILIZATION SERVICES.
P930014|S040|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/01/2010|||OK30|CHANGE TO THE LENS BENCH ALARM SYSTEM.
P040020|S024|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/01/2010|||OK30|CHANGE TO THE LENS BENCH ALARM SYSTEM.
P880087|S015|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/01/2010|||OK30|CHANGE TO THE LENS BENCH ALARM SYSTEM.
P810032|S056|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/01/2010|||OK30|CHANGE TO THE LENS BENCH ALARM SYSTEM.
P840060|S033|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/01/2010|||OK30|CHANGE TO THE LENS BENCH ALARM SYSTEM.
P930014|S041|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|ELIMINATION OF A QUALITY CONTROL TEST DURING MANUFACTURING OF THE DEVICE.
P040020|S025|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|ELIMINATION OF A QUALITY CONTROL TEST DURING MANUFACTURING OF THE DEVICE.
P040025|S010|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP SYSTEM|MXM|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/03/2010|06/28/2010|||APPR|APPROVAL FOR THE OLYMPIC COOL-CAP SYSTEM SOFTWARE VERSION 2.0.
P880087|S016|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|ELIMINATION OF A QUALITY CONTROL TEST DURING MANUFACTURING OF THE DEVICE.
P840060|S034|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|ELIMINATION OF A QUALITY CONTROL TEST DURING MANUFACTURING OF THE DEVICE.
P810032|S057|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA INTRAOCULAR LENSES|HQL|OP|30-Day Notice||N|05/03/2010|06/02/2010|||OK30|ELIMINATION OF A QUALITY CONTROL TEST DURING MANUFACTURING OF THE DEVICE.
P980035|S167|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P010031|S196|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/MARQUIS/II & III MARQUIS/II PROTECT/SENTRY/MAXIMO ICDS & CONCERTO/CONCERTO II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P010015|S085|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P & INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P990001|S067|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P980016|S238|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/SECURA DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P970012|S067|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2010|06/02/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P030017|S104|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR SYSTEM (SCS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2010|06/03/2010|||OK30|ADDITION OF A REWORK PROCESS FOR THE DISTAL END OF THE SHORT TIP (ST) LINEAR LEAD.
P870076|S010|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING BAND AND APPLICATOR SYSTEMS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2010|06/02/2010|||OK30|CHANGE TO THE SUPPLIER OF THREE COMPONENTS.
P010013|S028|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2010|06/01/2010|||OK30|REPLACE A MANUAL TUBE CUTTING STEP WITH AN AUTOMATED METHOD.
P010019|S015|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2010|06/04/2010|||OK30|CHANGE TO THE USE OF AN AUTOMATED VISION INSPECTION SYSTEM.
P070027|S018|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT AAA STENT GRAFT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2010|06/18/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND LTD, OFFALY, IRELAND, AS AN ALTERNATIVE E-BEAM STERILIZATION SITE.
P070007|S018|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT TAA STENT GRAFT DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2010|06/18/2010|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND LTD, OFFALY, IRELAND, AS AN ALTERNATIVE E-BEAM STERILIZATION SITE.
P030017|S105|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2010|12/29/2010|||APPR|APPROVAL TO MODIFY THE ASSEMBLY PROCEDURES.
P010030|S020|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2010|06/09/2010|||OK30|MINOR TEST MODIFICATION TO AN ELECTRODE BELT FUNCTIONAL TEST.
P050007|S026|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2010|06/03/2010|||OK30|INCREASE IN ADHESIVE DISPENSING TIME.
P860004|S128|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/2010|12/03/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE INTRODUCER NEEDLE TIP, NEEDLE HUB, AND STYLET CAP MATERIALS FOR THE INTRODUCER NEEDLE USED WITH THE MODELS 8709, 8709SC, 8711 AND 8731SC INTRATHECAL CATHETERS AND MODEL 8598A REVISION KIT.
P020004|S052|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS WITH MODIFIED DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/2010|12/22/2010|||APPR|APPROVAL FOR A MODIFIED DELIVERY SYSTEM CALLED THE C3 DELIVERY SYSTEM FOR THE GORE EXCLUDER AAA ENDOPROSTHESIS.
P070009|S008|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C|LTI|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2010|07/30/2010|||APPR|APPROVAL FOR A DEVICE CHANGE TO ADD A SILICONE ADHESIVE TO BOND THE STRAIN RELIEF SLEEVE AND THE LOCKING CONNECTOR COMPONENTS OF THE INJECTION PORT.
P070009|S009|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER|LTI|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/2010|06/04/2010|||APPR|APPROVAL FOR MINOR CHANGES TO THE LABELING.
P980016|S239|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2010|06/03/2010|||OK30|CHANGE IN LOCATION FOR A SUPPLIER OF ZENER DIODES.
P010031|S197|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2010|06/03/2010|||OK30|CHANGE IN LOCATION FOR A SUPPLIER OF ZENER DIODES.
P990040|S011|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2010|06/09/2010|||OK30|TRANSFER THE SUPPLIER OF THE TANTALUM POWDER AND ELIMINATION OF REDUNDANT ELEMENTAL ANALYSIS AND REDUNDANT TANTALUM PARTICLE SIZE TESTING.
P980022|S073|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|DEV-0016 CARELINK PERSONAL SOFTWARE VERSION 1.0A|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2010|06/29/2010|||APPR|APPROVAL FOR A CHANGE TO THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES (DEV-0016).  THE SOFTWARE VERSION 1.0A IS A REVISION TO IMPLEMENT SEVERAL FEATURE ENHANCEMENTS AND CORRECTION OF THREE MINOR ANOMALIES.
P050023|S031|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/2010|06/18/2010|||APPR|APPROVAL FOR THE CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE.
P950037|S081|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/2010|06/18/2010|||APPR|APPROVAL FOR THE CARDIOMESSENGER-S AND CARDIOMESSENGER-S TLINE.
P060037|S013|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE|NJL|OR|Special (Immediate Track)||N|05/12/2010|10/20/2010|||APPR|APPROVAL FOR THE ADDITION OF AN INSPECTION STEP FOR THE FLUTED STEM MOBILE TIBIAL BASEPLATE ENGRAVED LINE FEATURE.
P050012|S024|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2010|06/09/2010|||OK30|CHANGE TO IMPROVE THE MANUFACTURING CONSISTENCY OF THE SENSOR COMPONENT OF THE SEVEN® AND THE SEVEN® PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM.
P020004|S053|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2010|10/08/2010|||APPR|APPROVAL FOR MODIFICATIONS TO SETTINGS AND ASSOCIATED SOFTWARE TO THE LASER/TORQUE, OLIVE BONDING, TRANSITION FORMING, AND TORQUE BUMP STATIONS.
P030022|S014|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2010|06/11/2010|||OK30|CHANGE IN THE HA COATING VENDOR.
P070015|S037|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2010|06/11/2010|||OK30|EXTENDING THE RETEST PERIOD FOR THE EVEROLIMUS DRUG.
P960013|S060|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL STS MODELS 2088TC & 1988TC LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2010|06/10/2010|||OK30|ALTERNATE VENDOR FOR THE SOFT TIP COMPONENT.
P090022|S001|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/13/2010|06/17/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE OPTIC DESIGN OF THE SOFTEC HD LENS TO INTRODUCE BI-SPHERIC OPTIC SURFACES AND CHANGES TO THE LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC I AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21.  THE LENS IS INDICATED FOR CAPSULAR BAG REPLACEMENT.
P960058|S085|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/13/2010|08/24/2010|||APPR|APPROVAL FOR A NEW VERSION OF FITTING SOFTWARE, CALLED SOUNDWAVE 2.0.
P060025|S005|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|ATS 3F AORTIC BIOPROSTHESIS MODEL 1000|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/14/2010|07/13/2010|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL.
P000058|S037|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2010|07/24/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WYETH FARMA, S.A, IN DE LOS REYES, SPAIN.
P050053|S015|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2010|07/24/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WYETH FARMA, S.A, IN DE LOS REYES, SPAIN.
P970055|S009|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|MYM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2010|06/10/2010|||OK30|PROCEDURE CHANGE FOR A COMPONENT.
P060040|S010|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/08/2010|05/07/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P090003|S002|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PERMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|06/11/2010|||OK30|MODIFICATION TO THE BALLOON WING-FOLDING MACHINE.
P960022|S006|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS TORIC & SOFLENS66 (ALPHAFICON A) VISIBILITY TINTED CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|06/16/2010|||OK30|ADDITION OF A NEW SUPPLIER OF CROSSLINKING MATERIAL.
P080006|S008|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|06/16/2010|||OK30|TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
P060027|S024|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT-D AND PARADYM CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2010|06/28/2010|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION SMARTVIEW 2.20UG1 FOR USE WITH THE OVATION AND PARADYM ICDS AND CRT-DS AND THE REPLY AND ESPRIT PACEMAKERS.
P990013|S026|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|08/26/2010|||OK30|RELOCATION OF THE GLEBAR CENTERLESS GRINDER AND SPECIALTY MACHINE SLICER.
P980049|S057|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO VR/DR AND PARADYM VR/DR ICDS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2010|06/28/2010|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION SMARTVIEW 2.20UG1 FOR USE WITH THE OVATION AND PARADYM ICDS AND CRT-DS AND THE REPLY AND ESPRIT PACEMAKERS.
P950029|S053|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY / ESPRIT PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2010|06/28/2010|||APPR|APPROVAL FOR PROGRAMMER SOFTWARE VERSION SMARTVIEW 2.20UG1 FOR USE WITH THE OVATION AND PARADYM ICDS AND CRT-DS AND THE REPLY AND ESPRIT PACEMAKERS.
P030016|S014|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENS|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|08/26/2010|||OK30|RELOCATION OF THE GLEBAR CENTERLESS GRINDER AND SPECIALTY MACHINE SLICER.
P090003|S003|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|10/04/2010|||APPR|APPROVAL FOR AN ALTERNATE STENT FINISHING PROCESS USING AN AUTOMATED SYSTEM IN PLACE OF THE CURRENT MANUAL SYSTEM.
P060006|S013|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|10/04/2010|||APPR|APPROVAL FOR AN ALTERNATE STENT FINISHING PROCESS USING AN AUTOMATED SYSTEM IN PLACE OF THE CURRENT MANUAL SYSTEM.
P040047|S017|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|06/16/2010|||OK30|ADDITION OF TWO NEW CLEAN ROOM SUITES.
P050037|S023|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|11/06/2012|||APPR|APPROVAL FOR ADDITION OF NEW CLEAN SUITES TO EXISTING CLEAN ROOM FACILITY.
P050052|S026|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2010|11/06/2012|||APPR|APPROVAL FOR ADDITION OF NEW CLEAN SUITES TO EXISTING CLEAN ROOM FACILITY.
P990001|S068|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C & T SERIES IPGS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2010|03/22/2011|||APPR|APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
P890003|S192|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK DDMA SOFTWARE AND CARELINK MONITOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2010|03/22/2011|||APPR|APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
P970012|S068|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2010|03/22/2011|||APPR|APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
P980016|S240|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2010|03/22/2011|||APPR|APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
P980035|S168|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2010|03/22/2011|||APPR|APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
P010015|S086|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P & INSYNC III CRT-P|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2010|03/22/2011|||APPR|APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
P010031|S198|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CONCERTO II/CONSULTA/MAXIMO II CRT-DS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/17/2010|03/22/2011|||APPR|APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.
P010023|S003|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2010|09/30/2010|||APPR|APPROVAL FOR A CHANGE IN THE MAGNET CANISTER MANUFACTURING PROCESS/INSPECTION, AND THE RE-QUALIFICATION OF THE MAGNETIZATION VENDOR AT THE VENDOR¿S NEW FACILITY LOCATION.
P060023|S001|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|BRYAN CERVICAL DISC|MJO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/18/2010|03/09/2012|||APPR|APPROVAL FOR A MODIFIED SURGICAL TECHNIQUE, NEW INSTRUMENTATION, AND MODIFIED LABELING TO INCLUDE INFORMATION ON MRI COMPATIBILITY OF THE IMPLANTED DEVICE.
P060008|S053|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2010|12/01/2010|||APPR|APPROVAL FOR: 1) A CHANGE OF THE SUPPLIER OF TOLUENE; AND 2) A CHANGE TO THE INCOMING TOLUENE SPECIFICATIONS.  THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <= 28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >= 2.5 MM TO <= 4.00 MM IN DIAMETER.
P060012|S002|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2010|06/03/2010|||OK30|CHANGE TO THE MATCHING TEST PROCEDURE TO ALLOW OPTIMIZATION OF MICROPARTICLE PERCENT SOLIDS BASED ON A TARGET INDEX CALIBRATOR SIGNAL RATE COUNT.
P000025|S048|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2010|10/01/2010|||OK30|ADDITION OF ANOTHER SUPPLIER FOR THE FEEDTHROUGH ASSEMBLY COMPONENT.
P910023|S233|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2010|07/09/2010|||APPR|APPROVAL FOR SOFTWARE VERSION 4.6 FOR THE MERLIN.NET SYSTEM AND MERLIN@HOME MODEL EX2000 VERSION 4.6 SOFTWARE FOR THE MERLIN@HOME DEVICES.
P030054|S149|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-D SYSTEM|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2010|07/09/2010|||APPR|APPROVAL FOR SOFTWARE VERSION 4.6 FOR THE MERLIN.NET SYSTEM AND MERLIN@HOME MODEL EX2000 VERSION 4.6 SOFTWARE FOR THE MERLIN@HOME DEVICES.
P050010|S007|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-L TOTAL DISC REPLACEMENT|MJO|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2010|01/14/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN WEST CHESTER, PENNSYLVANIA.
P070001|S004|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-C TOTAL DISC REPLACEMENT|MJO|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2010|01/14/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN WEST CHESTER, PENNSYLVANIA.
P850051|S073|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MODEL 2090 MEDTRONIC CARELINK PROGRAMMER|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P980016|S241|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P060001|S009|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2010|06/18/2010|||OK30|MODIFICATION TO THE MOLDED TIP RAW MATERIAL.
P010033|S016|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB GOLD IN-TUBE|NCD|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2010|12/17/2010|||APPR|APPROVAL TO RELOCATE THE PEPTIDE FORMULATION FOR THE BLOOD COLLECTION TUBES FROM AUSTRALIA TO THE USA FACILITY IN CALIFORNIA.
P890003|S193|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SYNERGYST  II PULSE GENERATOR MODELS 7070 & 7071|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P040044|S032|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|5F & 6/7F MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2010|06/17/2010|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO APPLY LIGHT FINGERTIP COMPRESSION PROXIMAL TO THE INSERTION SITE BEFORE DEFLATING AND REMOVING THE BALLOON CATHETER.
P900061|S089|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P970012|S069|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P980035|S169|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P980050|S049|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P060008|S054|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2010|06/18/2010|||OK30|CHANGES TO THE DRUG ASSAY AND CONTENT UNIFORMITY METHOD, AND THE DRUG IMPURITIES AND DEGRADATION METHOD.
P990001|S069|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C & T SERIES IPGS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P010015|S087|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P & INSYNC III CRT-P|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P010031|S199|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II/CONSULTA/MAXIMO II CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2010|07/15/2010|||APPR|APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
P960013|S061|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS|NVN|CV|Normal 180 Day Track||N|05/20/2010|08/13/2015|||APPR|APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.
P960030|S031|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS|NVY|CV|Normal 180 Day Track||N|05/20/2010|08/13/2015|||APPR|APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.
P030054|S150|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE, QUICKFLEX, AND QUICKFLEX LEADS|NIK|CV|Normal 180 Day Track||N|05/20/2010|08/13/2015|||APPR|APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.
P030050|S008|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AESTHETIC|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/19/2010|09/09/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000008|S018|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Special (Immediate Track)||N|05/21/2010|06/18/2010|||APPR|APPROVAL TO MODIFY THE INSTRUCTIONS FOR USE TO ADD ¿DATA FROM A POST-APPROVAL STUDY SHOWED AN ESTIMATED EXPLANT RATE OF 6.5% PER YEAR OVER THE FIRST FIVE YEARS FOLLOWING IMPLANTATION¿ TO THE ADVERSE EVENTS SECTION.
P060025|S006|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|ATS 3F AORTIC BIOPROSTHESIS MODEL 100|LWR|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/21/2010|06/17/2010|||APPR|APPROVAL FOR REVISED INSTRUCTIONS FOR USE.
P910023|S234|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/23/2010|||OK30|ALTERNATE METALLIZATION OF DISCRETE COMPONENTS.
P030054|S151|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/23/2010|||OK30|ALTERNATE METALLIZATION OF DISCRETE COMPONENTS.
P880086|S187|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/23/2010|||OK30|ALTERNATE METALLIZATION OF DISCRETE COMPONENTS.
P030035|S068|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/23/2010|||OK30|ALTERNATE METALLIZATION OF DISCRETE COMPONENTS.
P910023|S235|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/18/2010|||OK30|ALTERNATE METHOD OF BIOBURDEN TESTING.
P030054|S152|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/18/2010|||OK30|ALTERNATE METHOD OF BIOBURDEN TESTING.
P880086|S188|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/18/2010|||OK30|ALTERNATE METHOD OF BIOBURDEN TESTING.
P030035|S069|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/18/2010|||OK30|ALTERNATE METHOD OF BIOBURDEN TESTING.
P880006|S066|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/18/2010|||OK30|ALTERNATE METHOD OF BIOBURDEN TESTING.
P970013|S033|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2010|06/18/2010|||OK30|ALTERNATE METHOD OF BIOBURDEN TESTING.
P020016|S005|BIOMET MICROFIXATION, INC.|1520 TRADEPORT DR.||JACKSONVILLE|FL|32218||Joint, temporomandibular, implant|TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM|LZD|DE|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|05/18/2010|11/08/2010|||APPR|APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET STUDY FOR THE WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.
P850010|S030|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/22/2010|||OK30|CHANGE IN MANUFACTURING EQUIPMENT.
P810006|S033|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN SPONGE HEMOSTATIC AGENT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/22/2010|||OK30|CHANGE IN MANUFACTURING EQUIPMENT.
P840062|S020|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE & COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/22/2010|||OK30|CHANGE IN MANUFACTURING EQUIPMENT.
P010013|S029|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/23/2010|||OK30|CHANGE IN THE METHOD OF MEASURING THE DIMENSIONS OF TWO COMPONENTS OF THE NOVASURE SYSTEM.
P000040|S015|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/24/2010|07/16/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P840064|S042|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC, VISCOAT, AND DUOVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/16/2010|||OK30|EXPANSION OF THE USE OF A PREVIOUSLY APPROVED CLEANROOM FOR ASEPTIC FILLING TO INCLUDE ASEPTIC COMPOUNDING.
P890047|S030|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|DISCOVISC, VISCOAT AND DUOVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/16/2010|||OK30|EXPANSION OF THE USE OF A PREVIOUSLY APPROVED CLEANROOM FOR ASEPTIC FILLING TO INCLUDE ASEPTIC COMPOUNDING.
P990023|S009|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/16/2010|||OK30|USE OF A NEWLY CONSTRUCTED CLEANROOM FOR ASEPTIC COMPOUNDING AND ASEPTIC FILLING PROCESSES.
P840064|S043|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC/VISCOAT/DUOVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/16/2010|||OK30|USE OF A NEWLY CONSTRUCTED CLEANROOM FOR ASEPTIC COMPOUNDING AND ASEPTIC FILLING PROCESSES.
P890047|S031|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/16/2010|||OK30|USE OF A NEWLY CONSTRUCTED CLEANROOM FOR ASEPTIC COMPOUNDING AND ASEPTIC FILLING PROCESSES.
P020009|S064|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 STENT DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/23/2010|||OK30|FIXTURE CHANGE IN THE HEAT SET EQUIPMENT.
P060008|S055|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/23/2010|||OK30|FIXTURE CHANGE IN THE HEAT SET EQUIPMENT.
P040016|S058|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTÉ) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2010|06/23/2010|||OK30|FIXTURE CHANGE IN THE HEAT SET EQUIPMENT.
P050020|S024|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2010|07/09/2010|||OK30|MODIFICATION OF THE INJECTION MOLDED TRAY WHICH PROTECTS THE SENSOR DELIVERY UNIT OF THE DEVICE DURING SHIPPING.
P980016|S243|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA VR/MAXIMO II VR/VIRTUOSO II VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2010|06/23/2010|||OK30|CHANGE TO THE ICCD TEST LIMITS.
P900056|S100|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2010|06/23/2010|||OK30|CHANGE TO COMPONENT MATERIALS.
P860019|S256|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2010|06/23/2010|||OK30|CHANGE TO THE POST-SWAGED INSPECTION METHOD FROM A MANUAL TO AN AUTOMATED PROCESS.
P980022|S075|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MYSENTRY SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/25/2010|12/20/2011|||APPR|APPROVAL FOR THE MYSENTRY SYSTEM, WHICH INCLUDES A MONITOR/ (MMT-9101) AND A REMOTE OUTPOST (MMT-9102), FOR USE WITH THE PARADIGM REAL-TIME SYSTEM. THE NEW MANUFACTURING FACILITY FOR THE MYSENTRY SYSTEM IS FLEXTRONICS INDUSTRIAL (SHENZHEN) CO., LTD, LOCATED IN SHENZHEN, CHINA.
P030017|S106|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2010|06/23/2010|||OK30|CHANGE IN THE ASSEMBLY OF THE CHARGER 2.0 PRINTED CIRCUIT BOARD (PCB) AT THE CURRENT SUPPLIER.
P860004|S129|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED & SYNCHROMED EL IMPLANTABLE PROGRAMMABLE INFUSION PUMPS|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2010|01/14/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS (THAILAND) PUBLIC COMPANY LIMITED IN AYUDHAYA, THAILAND FOR THE PURCHASING OF COMPONENTS, RECEIVING INSPECTION, PACKAGING, LABELING AND FINAL INSPECTION OF THE MODEL 8529 MAGNET AT THIS FACILITY.
P070014|S015|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2010|06/23/2010|||OK30|NEW MANUFACTURING AID.
P860004|S130|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED 2 MODEL 8637 PROGRAMMABLE DRUG INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/26/2010|07/01/2011|||APPR|APPROVAL FOR DESIGN CHANGES TO THE BATTERY FOR THE SYNCHROMED II MODEL 8637 PROGRAMMABLE DRUG INFUSION SYSTEM.
P020052|S006|St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER|MTE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/27/2010|06/25/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE.
P960016|S029|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC AND SAFIRE ABLATION CATHETERS|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/27/2010|06/25/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE.
P000027|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA CALCHECK|MTG|IM|30-Day Notice||N|05/27/2010|06/08/2010|||OK30|CHANGE IN MANUFACTURING SITE FOR FINAL PACKAGING AND LABELING OF THE DEVICE.
P010054|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS CALCHECK|LOM|MI|30-Day Notice||N|05/27/2010|06/04/2010|||OK30|CHANGE IN MANUFACTURING SITE FOR PACKAGING AND LABELING OF THE DEVICE.
P970003|S110|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM PULSE GENERATOR CLEANING PROCESS CHANGE|LYJ|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|11/05/2010|||APPR|APPROVAL TO CHANGE THE GENERATOR CLEANING PROCESS.
P040037|S026|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|06/23/2010|||OK30|ALTERNATE METHOD FOR APPLYING HEPARIN COATING.
P070001|S005|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC C TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|11/19/2010|||APPR|APPROVAL FOR A CHANGE IN THE BARREL BLASTING PROCESS.
P070001|S006|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRO-DISC C TOTAL DISC REPLACEMENT|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|06/25/2010|||OK30|CHANGE IN THE HA COATING VENDOR.
P920047|S042|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER PRIME HTD CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|06/30/2010|||OK30|ADDITION OF A 70% ISOPROPYL ALCOHOL WIPE IN THE MANUFACTURING PROCESS.
P020025|S023|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|06/30/2010|||OK30|ADDITION OF A 70% ISOPROPYL ALCOHOL WIPE IN THE MANUFACTURING PROCESS.
P980035|S170|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|06/25/2010|||OK30|REPLACEMENT OF THE LEGACY ELECTRICAL TEST STATION.
P990001|S070|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DA+ C-SERIES AND DA+ T-SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|06/25/2010|||OK30|REPLACEMENT OF THE LEGACY ELECTRICAL TEST STATION.
P010015|S088|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P & INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2010|06/25/2010|||OK30|REPLACEMENT OF THE LEGACY ELECTRICAL TEST STATION.
P060033|S052|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|06/23/2010|||OK30|CHANGE TO A COMPONENT MANUFACTURING PROCESS.
P950037|S082|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|07/30/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY.
P980023|S041|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|KAINOX VCS, LINOX S/T/SD/TD, KENTROX SL-S/RV-S/SL/RV STEROID, LINOX(SMART) ST/TD LEADS|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|07/30/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY.
P000009|S039|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LEXOS DR/DR-T/VR/VR-T AND LUMOS DR-T/VR-T ICDS|MRM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|07/30/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY.
P050023|S032|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD|MRM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|07/30/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY.
P070008|S016|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS|NKE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|07/30/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY.																																																																								30-DAY NOTICES (135 DAY SUPPLEMENT WAS NOT REQUIRED) 																					SUMMARY OF PMA ORIGINALS & SUPPLEMENTS APPROVEDORIGINALS:				  		SUPPLEMENTS:						SUMMARY OF PMA ORIGINALS UNDER REVIEWTOTAL UNDER REVIEW:					TOTAL ACTIVE:						TOTAL ON HOLD:					NUMBER GREATER THAN 180 DAYS:			SUMMARY OF PMA SUPPLEMENTS UNDER REVIEWTOTAL UNDER REVIEW:					TOTAL ACTIVE:						TOTAL ON HOLD:					NUMBER GREATER THAN 180 DAYS:			SUMMARY OF ALL PMA SUBMISSIONS RECEIVEDORIGINALS:						SUPPLEMENTS:						SUMMARY OF PMA SUPPLEMENT PMA APPROVAL/DENIAL DECISION TIMESNUMBER OF APPROVALS:					NUMBER OF DENIALS:					AVERAGE DAYS FR RECEIPT TO DECISION (TOTAL TIME):	  FDA TIME:     DAYS  MFR TIME:   DAYS
P020047|S020|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK MINI VISION CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|06/23/2010|||OK30|OPTIMIZATION OF THE LASER POWER SETTING USED FOR SOFT TIP ATTACH.
P070014|S016|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|06/23/2010|||OK30|CHANGE IN RAW MATERIAL SUPPLIER FOR THE MANUFACTURING OF A COMPONENT OF THE DELIVERY CATHETER.
P080032|S001|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/28/2010|09/14/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860004|S131|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2010|06/24/2010|||OK30|CHANGE TO THE DISTAL END TAPER LENGTHS OF THE MEDTRONIC INTRATHECAL CATHETERS, MODELS 8709, 8709SC, AND 8711.
P080032|S002|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/28/2010|07/27/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030039|S016|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT|NBE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2010|07/01/2010|||APPR|APPROVAL FOR ADDING A LOT RELEASE SURVEILLANCE SAMPLE TEST FOR FUNCTIONALITY.
P070014|S017|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2010|06/23/2010|||OK30|ADDITION OF ALTERNATE TENSILE TESTING EQUIPMENT AS PART OF THE PACKAGE PEEL TESTING PROCEDURES.
P010025|S019|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2010|11/16/2010|||APPR|APPROVAL FOR ADDITIONAL AUTOMATIC EXPOSURE CONTROL (AEC) TECHNIQUE TABLES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
P840001|S154|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2010|06/30/2010|||OK30|CHANGE TO AN IN-LINE AUTOMATED OPTICAL INSPECTION (AOI) AND PRESSURIZED NITROGEN GAS CLEANING.
P970004|S086|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2010|06/30/2010|||OK30|CHANGE TO AN IN-LINE AUTOMATED OPTICAL INSPECTION (AOI) AND PRESSURIZED NITROGEN GAS CLEANING.
P960009|S084|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2010|06/30/2010|||OK30|CHANGE TO AN IN-LINE AUTOMATED OPTICAL INSPECTION (AOI) AND PRESSURIZED NITROGEN GAS CLEANING.
P860004|S132|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2010|06/30/2010|||OK30|CHANGE TO AN IN-LINE AUTOMATED OPTICAL INSPECTION (AOI) AND PRESSURIZED NITROGEN GAS CLEANING.
P070022|S004|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/2010|07/28/2010|||APPR|APPROVAL FOR CHANGING A CONTRAINDICATION IN THE ADIANA INSTRUCTION FOR USE TO REDUCE THE MINIMUM INTERVAL BETWEEN CONCLUSION OF A PREGNANCY AND THE ADIANA PROCEDURE FROM 12 WEEKS TO SIX WEEKS AND FOR ADDING A WARNING REGARDING INCOMPLETE UTERINE INVOLUTION.
P810002|S071|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2010|06/30/2010|||OK30|ELIMINATION OF A REDUNDANT IN-PROCESS INSPECTION STEP.
P070001|S007|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-C TOTAL DISC REPLACEMENT|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2010|07/02/2010|||OK30|MODIFIED FIXTURE USED FOR INSPECTION OF THE PRODISC-C ENDPLATES.
P980035|S171|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/SENSIA/VERSA/RELIA/ENRHYTHM IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2010|06/30/2010|||OK30|CHANGES RELATED TO HYBRID CLEANING AND INSPECTION PROCESS.
P980016|S244|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2010|06/30/2010|||OK30|CHANGES RELATED TO HYBRID CLEANING AND INSPECTION PROCESS.
P010031|S201|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC ICD MODEL 7272||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2010|06/30/2010|||OK30|CHANGES RELATED TO HYBRID CLEANING AND INSPECTION PROCESS.
P010015|S089|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2010|06/30/2010|||OK30|CHANGES RELATED TO HYBRID CLEANING AND INSPECTION PROCESS.
P040050|S005|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|07/02/2010|||OK30|ALTERNATE VENDOR FOR THE INNER AND OUTER MACROPLASTIQUE IMPLANTS PACKAGING.
P080015|S001|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|06/28/2010|||OK30|NEW SUPPLIER OF BOVINE SERUM ALBUMIN (BSA), A RAW MATERIAL USED IN THE PRODUCTION OF ONE COMPONENT OF THE DEVICE.
P060033|S053|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|07/01/2010|||OK30|CHANGE TO THE SPRAY WEIGH SYSTEM.
P060033|S055|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|06/30/2010|||OK30|CHANGE MANUFACTURING PROCESS EQUIPMENT.
P840001|S155|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREULTRA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|06/23/2010|||OK30|REPLACEMENT OF THE LEGACY ELECTRICAL TEST STATIONS AT THE FEEDTHROUGH.
P960009|S085|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA RC|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|06/23/2010|||OK30|REPLACEMENT OF THE LEGACY ELECTRICAL TEST STATIONS AT THE FEEDTHROUGH.
P000058|S038|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|12/07/2010|||APPR|APPROVAL FOR A CHANGE IN THE VIRAL FILTER USED IN THE PRODUCTION OF THE DIBOTERMIN ALFA DRUG SUBSTANCE.
P000054|S025|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|12/07/2010|||APPR|APPROVAL FOR A CHANGE IN THE VIRAL FILTER USED IN THE PRODUCTION OF THE DIBOTERMIN ALFA DRUG SUBSTANCE.
P050053|S016|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|12/07/2010|||APPR|APPROVAL FOR A CHANGE IN THE VIRAL FILTER USED IN THE PRODUCTION OF THE DIBOTERMIN ALFA DRUG SUBSTANCE.
P080014|S002|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2010|06/28/2010|||OK30|NEW SUPPLIER OF BOVINE SERUM ALBUMIN (BSA), A RAW MATERIAL USED IN THE PRODUCTION OF ONE COMPONENT OF THE DEVICE.
P060033|S056|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice||N|06/04/2010|07/01/2010|||OK30|CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.
P790017|S108|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|30-Day Notice||N|06/04/2010|07/01/2010|||OK30|CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.
P030009|S043|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRODRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice||N|06/04/2010|07/01/2010|||OK30|CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.
P070027|S019|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice||N|06/04/2010|07/01/2010|||OK30|CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.
P070007|S019|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice||N|06/04/2010|07/01/2010|||OK30|CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.
P990020|S040|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|30-Day Notice||N|06/04/2010|07/01/2010|||OK30|CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.
P030054|S153|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HR/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2010|03/04/2011|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030035|S070|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER 2 FAMILY OF CRT-PS|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/07/2010|03/04/2011|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880006|S067|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2010|03/04/2011|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880086|S189|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2010|03/04/2011|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P980049|S058|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM DR/VR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2010|07/09/2010|||OK30|CHANGE TO IN-SOURCE THE MICRO-ELECTRONIC ASSEMBLY OF ELECTRONIC HYBRIDE MODULES.
P910023|S236|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2010|03/04/2011|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P060027|S025|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2010|07/09/2010|||OK30|CHANGE TO IN-SOURCE THE MICRO-ELECTRONIC ASSEMBLY OF ELECTRONIC HYBRIDE MODULES.
P970013|S034|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/04/2010|03/04/2011|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P980022|S076|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSOR MMT-7002|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2010|11/17/2010|||APPR|APPROVAL FOR THE MODIFICATIONS OF THE COATING PROCESS FROM THE SPIN COATING PROCESS TO THE SLOT COATING PROCESS, AND THE ADHESION PROMOTER (AP) SOLUTION.
P070001|S008|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-C TOTAL DISC REPLACEMENT|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2010|07/02/2010|||OK30|UPDATE TO AN EXISTING HOLDING FIXTURE.
P020009|S065|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2010|04/01/2011|||APPR|APPROVAL FOR THE REMOVAL OF THE MONTHLY ONGOING PRODUCT PARTICULATE TESTING AT THE MAPLE GROVE MANUFACTURING FACILITIES.
P040016|S059|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2010|04/01/2011|||APPR|APPROVAL FOR THE REMOVAL OF THE MONTHLY ONGOING PRODUCT PARTICULATE TESTING AT THE MAPLE GROVE MANUFACTURING FACILITIES.
P060006|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2010|04/01/2011|||APPR|APPROVAL FOR THE REMOVAL OF THE MONTHLY ONGOING PRODUCT PARTICULATE TESTING AT THE MAPLE GROVE MANUFACTURING FACILITIES.
P980016|S245|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2010|07/07/2010|||OK30|ALTERNATE SUPPLIER OF A COMPONENT PLATING PROCESS.
P950037|S083|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA/ENTOVIS DR/DR-T/SR-T & VARIOUS OTHER MODELS OF PULSE GENERATORS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/2010|11/26/2010|||APPR|CHANGE IN THE USB CABLE ASSEMBLY, AS WELL AS THE SUPPLIER FOR THE CABLE, TO BE USED WITH THE ESTEEM PROGRAMMER.
P010031|S202|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONSULTA CRT-DS/CONCERTO II ICD/MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2010|07/07/2010|||OK30|ALTERNATE SUPPLIER OF A COMPONENT PLATING PROCESS.
P000009|S040|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T, & XELOS DR-T ICDS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/2010|11/26/2010|||APPR|APPROVAL FOR THE ATRIAL CAPTURE CONTROL AND VENTRICULAR PACING SUPPRESSION FEATURES INCLUDED IN VERSION 1002.U/1 PROGRAMMER SOFTWARE FOR THE EVIA/ENTOIS PULSE GENERATORS.
P050023|S033|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/2010|11/26/2010|||APPR|APPROVAL FOR THE ATRIAL CAPTURE CONTROL AND VENTRICULAR PACING SUPPRESSION FEATURES INCLUDED IN VERSION 1002.U/1 PROGRAMMER SOFTWARE FOR THE EVIA/ENTOIS PULSE GENERATORS.
P070008|S017|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T CRT-P|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/08/2010|11/26/2010|||APPR|APPROVAL FOR THE ATRIAL CAPTURE CONTROL AND VENTRICULAR PACING SUPPRESSION FEATURES INCLUDED IN VERSION 1002.U/1 PROGRAMMER SOFTWARE FOR THE EVIA/ENTOIS PULSE GENERATORS.
P050044|S014|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/08/2010|||OK30|USE OF NEW PACKAGING MATERIAL FOR THE DEVICE.
P030019|S015|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/15/2010|||OK30|INCREASE IN STORAGE TIME FOR DEPYROGENATED EQUIPMENT FROM 48 HOURS TO 5 DAYS.
P030031|S030|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/15/2010|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER FOR THE TIP DOME ELECTRODE.
P940015|S019|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC & SYNVISC-ONE|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|09/15/2010|||APPR|P940015/S0199/15/10135-DAY	SYNVISC/SYNVISC-ONE AND PREVELLE SILK	GENZYME BIOSURGERYCAMBRIDGE, MA02142	APPROVAL FOR A MANUFACTURING CHANGE INVOLVING INSTALLATION OF THE WATERS EMPOWER 2 CHROMATOGRAPHY DATA SYSTEM.
P030032|S010|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|PREVELLE SILK|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|09/15/2010|||APPR|P940015/S0199/15/10135-DAY	SYNVISC/SYNVISC-ONE AND PREVELLE SILK	GENZYME BIOSURGERYCAMBRIDGE, MA02142	APPROVAL FOR A MANUFACTURING CHANGE INVOLVING INSTALLATION OF THE WATERS EMPOWER 2 CHROMATOGRAPHY DATA SYSTEM.
P040016|S060|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) STENT DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/08/2010|||OK30|CHANGE TO IN-PROCESS STENT INSPECTION.
P060008|S056|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE & TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/08/2010|||OK30|CHANGE TO IN-PROCESS STENT INSPECTION.
P080006|S009|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/08/2010|||OK30|IMPLEMENTATION OF A NEW MANUFACTURING TRACEABILITY SYSTEM.
P010015|S090|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN OTW & ATTAIN BIPOLAR OTW|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/08/2010|||OK30|IMPLEMENTATION OF A NEW MANUFACTURING TRACEABILITY SYSTEM.
P060039|S012|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/08/2010|||OK30|IMPLEMENTATION OF A NEW MANUFACTURING TRACEABILITY SYSTEM.
P030036|S017|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2010|07/08/2010|||OK30|IMPLEMENTATION OF A NEW MANUFACTURING TRACEABILITY SYSTEM.
P040040|S014|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/09/2010|10/01/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980040|S034|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ONE-PIECE SOFT ACRYLIC INTRAOCULAR (IOL) MODEL ZCB00 & TECNIS MULTIFOCAL ONE-PIECE IOL MODEL ZMB00|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2010|07/08/2010|||OK30|ADDITION OF A COSMETIC INSPECTION STEP TO THE MANUFACTURING PROCESS OF ONE-PIECE INTRAOCULAR LENSES.
P070007|S020|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2010|07/08/2010|||OK30|ADDITION OF AN IN-PROCESS MANUFACTURING STENT LOADING AID.
P070027|S020|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASULAR TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2010|07/08/2010|||OK30|ADDITION OF AN IN-PROCESS MANUFACTURING STENT LOADING AID.
P980035|S172|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2010|07/08/2010|||OK30|ADDING NEW TEST EQUIPMENT.
P980022|S077|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK TRANSMITTER (MMT-7703) AND IPRO DIGITAL RECORDER (MMT-7709)|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2010|07/12/2010|||APPR|APPROVAL FOR AN ESD PROTECTION DIODE CHANGE TO THE MINILINK TRANSMITTER (MMT-7703) AND IPRO DIGITAL RECORDER (MMT-7709).
P980016|S246|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2010|07/08/2010|||OK30|ADDING NEW TEST EQUIPMENT.
P950032|S058|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2010|07/27/2010|||APPR|APPROVAL FOR THE INTRODUCTION OF KERATINOCYTE CELL STRAIN (HEP081) INTO THE MANUFACTURE OF APLIGRAF.
P060038|S007|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2010|07/08/2010|||OK30|EXPANDED USE OF AN EXISTING ISOLATOR.
P860057|S069|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2010|07/09/2010|||OK30|ADDITION OF A NEW SUPPLIER FOR BOVINE PERICARDIAL TISSUE.
P930038|S062|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2010|07/15/2010|||OK30|ALTERNATE SEAL STRENGTH SPECIFICATION ASSURANCE METHOD.
P060003|S005|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM AUSAB|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|06/11/2010|06/09/2011|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING AND QUALITY CONTROL TESTING FOR AXSYM AUSAB CALIBRATORS, CONTROLS, AND REAGENTS.
P050027|S001|KARL STORZ ENDOSCOPY-AMERICA, INC.|2151 E. GRAND AVE.||EL SEGUNDO|CA|90245||Light source system, diagnostic endoscopic|KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM|OAY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/11/2010|08/10/2010|||APPR|APPROVAL FOR: 1) REPLACEMENT OF THE EXISTING KARL STORZ CAMERA CONTROL UNIT (CCU), TRADE NAME ¿TRICAM SL,¿ WITH A NEW MODEL TO BE MARKETED UNDER THE TRADE NAME ¿TRICAM SL II¿; AND 2) MINOR LABELING CHANGES TO REFLECT THE CHANGE IN THE CCU TRADE NAME.
P000040|S016|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2010|07/08/2010|||OK30|IMPLEMENTATION OF AN INSPECTION AT THE CASSETTE MANUFACTURER AND AN UPDATE TO A SUBASSEMBLY DRAWING.
P000006|S021|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2010|07/14/2010|||OK30|USE OF A NEW MOLD BY A NEW VENDOR AND MODIFICATION OF THE CURRENT ENGINEERING DRAWING.
P950022|S071|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA FAMILY OF LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2010|07/15/2010|||OK30|CHANGE IN THE MEDICAL ADHESIVE CLEANING PROCESS.
P980035|S173|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/15/2010|08/02/2010|||APPR|APPROVAL FOR THE CHANGE IN DELTA 30H BATTERY SPECIFICATION.
P050012|S025|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN AND SEVEN PLUS SYSTEM|MDS|CH|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/15/2010|07/15/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING TO INCLUDE MORE EMPHASIS ON THE ALERT TO USERS ABOUT THE POTENTIAL FOR THE TIPS OF SENSORS BREAKING OFF AND TO PROVIDE RECOMMENDATIONS TO USERS REGARDING THEIR ACTIONS SHOULD THIS OCCUR.
P010015|S092|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC 3 CRT-P|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/15/2010|08/02/2010|||APPR|APPROVAL FOR THE CHANGE IN DELTA 30H BATTERY SPECIFICATION.
P870076|S011|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING BAND & APPLICATOR SYSTEMS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2010|07/08/2010|||OK30|CHANGE IN SUPPLIER OF THREE COMPONENTS OF THE DEVICE.
P960042|S017|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS SLS II LASER SHEATH|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2010|07/15/2010|||OK30|CHANGE TO THE VACUUM OVEN.
P980022|S078|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK TRANSMITTER (MMT-7703) & IPRO DIGITAL RECORDER (MMT-7709)|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2010|07/15/2010|||OK30|CHANGE TO A NEW COMPONENT SUPPLIER FOR THE CAPACITOR USED IN THE DEVICE.
P980022|S079|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR GLUCOSE SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2010|07/15/2010|||OK30|MODIFICATION OF THE GLM ONTO 8 PLATES AT A TIME WITH 48 SENSORS PER PLATE FROM 24 SENSORS PER PLATE.
P090018|S002|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/17/2010|08/16/2010|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL.
P910023|S237|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2010|07/15/2010|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR DISCRETE COMPONENTS USED ON ST. JUDE MEDICAL¿S DEVICES.
P090018|S003|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/17/2010|08/16/2010|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL.
P030054|S154|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2010|07/15/2010|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR DISCRETE COMPONENTS USED ON ST. JUDE MEDICAL¿S DEVICES.
P880086|S190|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2010|07/15/2010|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR DISCRETE COMPONENTS USED ON ST. JUDE MEDICAL¿S DEVICES.
P050048|S005|BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2010|11/23/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIO-RAD LABORATORIES IN WOODINVILLE, WASHINGTON.
P030035|S071|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2010|07/15/2010|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR DISCRETE COMPONENTS USED ON ST. JUDE MEDICAL¿S DEVICES.
P060031|S004|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|MONOLISA ANTI-HBC EIA|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2010|11/23/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIO-RAD LABORATORIES IN WOODINVILLE, WASHINGTON.
P060034|S005|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|MONOLISA ANTI-HBC IGM EIA|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2010|11/23/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIO-RAD LABORATORIES IN WOODINVILLE, WASHINGTON.
P020018|S036|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT & ZENITH RENU AAA ANCILLARY GRAFT WITH Z-TRAK INTRODUCTION SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/15/2010|||OK30|ADDITION OF A QUALITY CONTROL TEST TO THE CAPTOR HEMOSTATIC VALVE TUBING SUBASSEMBLY PROCESS.
P070015|S038|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|09/15/2010|||APPR|APPROVAL FOR A CHANGE TO THE IN-PROCESS SAMPLING AND TESTING PLAN FOR THE PRIMER AND DRUG COATING SOLUTIONS.
P050048|S006|BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI -HBS EIA|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|09/27/2010|||APPR|APPROVAL FOR A CHANGE IN SUPPLIER FOR THE HEPATITIS B ANTIGENS USED IN THE MANUFACTURE OF THE DEVICE.
P090003|S004|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/15/2010|||OK30|CHANGES TO THE LAP WELD PROCESS AND THE ADDITION OF AN IN-PROCESS INSPECTION SPECIFICATION.
P880086|S191|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/16/2010|||OK30|CHANGE TO THE RESISTANCE WELD PROCESS ELECTRODE.
P980043|S027|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS MODELS T505 & T510|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/28/2010|||OK30|ADDITION OF A COMPONENT MANUFACTURER.
P790007|S026|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/28/2010|||OK30|ADDITION OF A COMPONENT MANUFACTURER.
P970004|S087|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MODEL 3058 INTERSTIM 2 NEUROSTIMULATOR|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/24/2010|06/09/2011|||APPR|APPROVAL FOR DESIGN AND SPECIFICATION CHANGES TO THE MODEL 3058 INTERSTIM II BATTERY.
P870078|S010|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT MODEL 105|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/28/2010|||OK30|ADDITION OF A COMPONENT MANUFACTURER.
P980035|S174|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/16/2010|||OK30|CHANGES IN PLATINUM FLOW ON COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) AT THE SUPPLIER LOCATION.
P010031|S203|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II CRT-DS/CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/16/2010|||OK30|CHANGES IN PLATINUM FLOW ON COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) AT THE SUPPLIER LOCATION.
P980016|S247|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2010|07/16/2010|||OK30|CHANGES IN PLATINUM FLOW ON COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) AT THE SUPPLIER LOCATION.
P810025|S028|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC & AMVISC PLUS|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/21/2010|05/15/2012|||APPR|APPROVAL FOR AN ALTERNATE RAW MATERIAL SOURCE (LIFECORES FERMENTATION-BASED SODIUM HYALURONATE) AND ALTERNATE MANUFACTURING SITE (LIFECORE BIOMEDICAL, LLC, CHASKA, MN) FOR RAW MATERIAL AND FINISHED PRODUCTS.
P030011|S008|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/21/2010|10/26/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P990066|S037|GE Healthcare|3000 N. GRANDVIEW BLVD||WAUKESHA|WI|53188||Full field digital,system,x-ray,mammographic|GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2010|11/05/2010|||APPR|APPROVAL TO REPLACE THE CURRENT IMAGE RECEPTOR/DETECTOR SUPPLIER.
P910077|S105|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2010|07/22/2010|||OK30|CHANGE IN THE BOND LINE THICKNESS AND LEAD FRAME PLATING FOR THE DIGITAL POTENTIOMETER.
P080023|S002|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECH CORE|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2010|01/04/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN DELKENHEIM, GERMANY FOR THE MANUFACTURE OF ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR, AND ARCHITECT CORE CONTROLS.
P070015|S039|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2010|07/23/2010|||OK30|MODIFICATION OF THE STENT CRIMP MANUFACTURING PROCESS BY ELIMINATING THE REDUNDANT INSPECTION THAT OCCUR AT THE PRE-CRIMP STAGE.
P970004|S088|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II MODEL 3058 DEVICE|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2010|07/14/2010|||OK30|CHANGE TO THE TEST SPECIFICATION LIMITS OF AN EXISTING MANUFACTURING TEST RELATED TO THE FINAL FUNCTIONAL TEST.
P970003|S111|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/22/2010|08/04/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030054|S155|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Drug eluting permanent left ventricular (lv) pacemaker electrode|ST. JUDE MEDICAL EPIC HF SYSTEM|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/22/2010|02/11/2011|||APPR|APPROVAL FOR A NEW 4.3-4.7 FR SLIT SUTURE SLEEVE ACCESSORY KIT TO BE USED WITH THE APPROVED 1258T QUICKFLEX ¿ LEAD.
P990033|S017|CERAMED CORP.|12860 WEST CEDAR DRIVE,|SUITE 108|LAKEWOOD|CO|80228||Bone grafting material, dental, with biologic component|PEPGEN P-15 FLOW|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2010|07/20/2010|||OK30|USE OF AN ALTERNATE FOIL POUCH SUPPLIER AND ALTERNATE AUTOCLAVE STERILIZER.
P990004|S018|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/2010|07/28/2010|||APPR|APPROVAL TO CHANGE THE INSTRUCTIONS FOR USE TO ADD SPECIFIC DIRECTIONS FOR USE OF THE DEVICE IN ENDOSCOPIC AND/OR LAPAROSCOPIC PROCEDURES.
P900061|S090|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE DEFRIBRILLAITON LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2010|07/23/2010|||OK30|CHANGES AT THE FINAL PACKAGE ASSEMBLY.
P040021|S012|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2010|11/05/2010|||APPR|APPROVAL FOR REMOVAL OF A FINAL PRODUCT QUALITY INSPECTION.
P980016|S248|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2010|07/23/2010|||OK30|CHANGES TO L409 INTEGRATED CIRCUIT TEST.
P010031|S204|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2010|07/23/2010|||OK30|CHANGES TO L409 INTEGRATED CIRCUIT TEST.
P970020|S056|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ZETA CORONARY STENT SYSTEMS (CSS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2010|07/20/2010|||OK30|INCREASE IN THE MINIMUM SEAL LENGTH REQUIREMENT FOR THE MANUFACTURING OF THE STENT DELIVERY SYSTEM.
P020047|S021|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK/VISION/MINI VISION FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2010|07/20/2010|||OK30|INCREASE IN THE MINIMUM SEAL LENGTH REQUIREMENT FOR THE MANUFACTURING OF THE STENT DELIVERY SYSTEM.
P070015|S040|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice||N|06/23/2010|07/20/2010|||OK30|INCREASE IN THE MINIMUM SEAL LENGTH REQUIREMENT FOR THE MANUFACTURING OF THE STENT DELIVERY SYSTEM.
P030054|S156|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2010|07/21/2010|||APPR|APPROVAL FOR THE IMPROVEMENT OF THE MANUFACTURE AND QA PROCESS BY INSERTING THE INSPECTIONS TO THE BATTERY WELDING.
P910023|S238|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2010|07/21/2010|||APPR|APPROVAL FOR THE IMPROVEMENT OF THE MANUFACTURE AND QA PROCESS BY INSERTING THE INSPECTIONS TO THE BATTERY WELDING.
P030054|S157|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY CRT-D|NIK|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/2010|09/23/2010|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE LONGEVITY INFORMATION BASED ON ADDITIONAL BENCH TESTING.
P910023|S239|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FORTIFY VR/DR|NVZ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/2010|09/23/2010|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE LONGEVITY INFORMATION BASED ON ADDITIONAL BENCH TESTING.
P980016|S249|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2010|07/23/2010|||OK30|UPDATE TO THE LASER WELD PROCESS.
P010031|S205|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONCERTO II/CONSULTA/MAXIMO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2010|07/23/2010|||OK30|UPDATE TO THE LASER WELD PROCESS.
P980035|S175|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/ENPULSE/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2010|07/23/2010|||OK30|ADDITION OF A NEW PIECE OF EQUIPMENT USED IN THE BATTERY BURN-IN PROCESS.
P970012|S070|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2010|07/23/2010|||OK30|ADDITION OF A NEW PIECE OF EQUIPMENT USED IN THE BATTERY BURN-IN PROCESS.
P990013|S027|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2010|07/29/2010|||OK30|CHANGE OF THE SOLVENT USED IN THE DEWAXING PROCESS, AND TO IMPLEMENT REDESIGNED SIEVES.
P030016|S015|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENS|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2010|07/29/2010|||OK30|CHANGE OF THE SOLVENT USED IN THE DEWAXING PROCESS, AND TO IMPLEMENT REDESIGNED SIEVES.
P860004|S133|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|08/04/2010|||APPR|APPROVAL FOR INCORPORATING ADDITIONAL INSPECTIONS AND MINOR TOOLING MODIFICATIONS TO MINIMIZE THE POTENTIAL FOR THE PUMP TUBE COMPONENT TO BE DAMAGED DURING THE PUMP MANUFACTURING PROCESS OF THE SYNCHROMED II INFUSION SYSTEM, MODEL 8637.
P010013|S030|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/21/2010|||OK30|CHANGE IN THE COATING OF THE INDIVIDUAL CONDUCTIVE WIRES.
P040045|S014|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/18/2010|||APPR|APPROVAL FOR THE IMPLEMENTATION OF AN ALTERNATE METHOD FOR VISUAL INSPECTION OF RAW MATERIALS FOR VISTAKON® (SENOFILCONA) CONTACT LENSES, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER.
N18033|S047|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/22/2010|||OK30|ALTERNATE METHOD FOR VISUAL INSPECTION OF RAW MATERIALS.
P980022|S080|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|06/28/2010|08/23/2010|||APPR|APPROVAL FOR A CHANGE TO THE CARELINK PRO (MMT-7335).
P980035|S176|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM/RELIA/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/28/2010|||OK30|ADDITIONAL SUPPLIER FOR THE PERFORMANCE OF A PLATING PROCESS.
P990001|S071|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DA+C & DA+T SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/28/2010|||OK30|ADDITIONAL SUPPLIER FOR THE PERFORMANCE OF A PLATING PROCESS.
P840001|S156|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE/ITREL 3/SYNERGY FAMILIES OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/20/2010|||OK30|CHANGES TO THE TRACEABILITY SOFTWARE.
P060027|S026|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/2010|09/09/2010|||APPR|APPROVAL FOR REVISED EMBEDDED IMPLANT SOFTWARE (VERSION W2.8.4) AND REVISED SMARTVIEW PROGRAMMER SOFTWEAR (VERSION 2.22 UG2).
P970004|S089|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/20/2010|||OK30|CHANGES TO THE TRACEABILITY SOFTWARE.
P980049|S059|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/2010|09/09/2010|||APPR|APPROVAL FOR REVISED EMBEDDED IMPLANT SOFTWARE (VERSION W2.8.4) AND REVISED SMARTVIEW PROGRAMMER SOFTWEAR (VERSION 2.22 UG2).
P860004|S134|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/20/2010|||OK30|CHANGES TO THE TRACEABILITY SOFTWARE.
P960009|S087|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/20/2010|||OK30|CHANGES TO THE TRACEABILITY SOFTWARE.
P990034|S019|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SIDE CATHETER ACCESS PORT KITS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|07/20/2010|||OK30|CHANGES TO THE TRACEABILITY SOFTWARE.
P980016|S250|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P010015|S093|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN/INSYNC & INSYNC III|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P010031|S206|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/II/CONSULTA/INSYNC ICD/INSYNC MARQUIS/MAXIMO/INSYNC II MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P030036|S018|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE/ANCHORING SLEEVE KIT|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P060039|S013|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P080006|S010|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P820003|S095|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOSABLE COVER|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P830061|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALINE/VITATRON EXCELLENCE PS+/VITATRON EXCELLENCE +|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P850089|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/Z NOVUS/SP NOVUS/FIX/STERX TIP PACING LEAD (VENTRICULAR)/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P890003|S194|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE/BRILLIANT S+VDD LEADS/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P980050|S050|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P990001|S072|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CLARITY/DA+C & T SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/ SELECTION AFM/TOPAZ 3/II/VITA/VITA 2|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P900061|S091|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACCESSORY (UPSIZING SLEEVE)/UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP/MICRO JEWEL/II/TRANSVENE DEFIBR|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P920015|S061|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE CS/SVC/DF1/RV/SUBQ/SVC|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P930039|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/CAPSUREFIX NOVUS/CAPSUREFIX/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P950024|S021|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P970012|S071|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P980035|S177|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 600/700/800/900/RELIA/SENSIA/VERSA/SIGMA|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P930029|S023|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II/RF CONTACTR|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2010|11/10/2010|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P790002|S026|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET EBI BONE HEALING SYSTEM|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/2010|05/19/2011|||APPR|APPROVAL FOR A MODIFIED, REDESIGNED, NONINVASIVE PULSED ELECTROMAGNETIC FIELD BONE GROWTH STIMULATOR SYSTEM THAT USES NEW SFLX COILS.
P050023|S034|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS AND CRT-DS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2010|08/04/2010|||APPR|APPROVAL FOR THE TANTALUM HIGH VOLTAGE CAPACITORS (GB 80413) FOR LUMAX 340 AND LUMAX 540 ICD/CRT-D DEVICES.
P860019|S258|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2010|07/28/2010|||OK30|UPDATE OF SOFTWARE USED WITH A CAMERA FOR INSPECTING THE INNER COMPONENT AT THE APEX DISTAL LOAD MANUFACTURING PROCESS.
P070009|S010|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND APPLIER|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2010|07/26/2010|||OK30|ADDITION OF AN ALTERNATE SUB-ASSEMBLY SUPPLIER.
P990027|S015|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/2010|11/30/2010|||APPR|APPROVAL FOR THE ADVANCED NOMOGRAM SOFTWARE MODULE AS AN UPGRADE TO THE EXISTING SOFTWARE OF THE TECHNOLAS PERFECT VISION® 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION. THE ADVANCED NOMOGRAM RESIDES ON A SEPARATE COMPUTER WITH THE ZYLINK TREATMENTCALCULATION SOFTWARE, AND IT LEAVES ALL HARDWARE COMPONENTS AND THE LASER BEAM CONTROL SOFTWARE MODULE UNCHANGED. THE TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZEDVISION CORRECTION WITH ADVANCED NOMOGRAM SOFTWARE MODULE IS INDICATED FOR WAVEFRONT-GUIDEDLASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK):1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO-3.00 D AND MRSE <=7.50 D AT THE SPECTACLE PLANE;2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OREQUAL TO +-0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEARPRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION; AND3) IN PATIENTS 21 YEARS OF AGE OR OLDER.
P010025|S020|HOLOGIC, INC.|36 Apple Ridge Road||Danbury|CT|06810||Full field digital,system,x-ray,mammographic|HOLOGIC SELENIA DIMENSIONS 2D FULL DIGITAL MAMMOGRAPHY SYSTEM|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/2010|09/07/2010|||APPR|APPROVAL FOR THE SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
P010047|S004|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2010|08/05/2010|||OK30|CHANGE IN THE LOCATION OF THE CONTRACT MANUFACTURER OF ONE OF THE COMPONENTS.
P010019|S017|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2010|07/26/2010|||OK30|CHANGES TO OPTICAL TOOL MANUFACTURING.
P950022|S072|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|TRANSVENOUS DEFIBRILLATION LEAD|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2010|12/29/2010|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR A LEAD COMPONENT.
P840001|S157|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOR IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2010|07/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS.
P960009|S088|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2010|07/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS.
P970004|S090|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2010|07/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS.
P860004|S135|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PROGRAMMABLE DRUG PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2010|07/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS.
P980016|S251|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2010|07/28/2010|||OK30|IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER.
P980035|S178|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2010|07/28/2010|||OK30|IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER.
P010031|S207|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONSULTA & MAXIMO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2010|07/28/2010|||OK30|IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER.
P030054|S158|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Drug eluting permanent left ventricular (lv) pacemaker electrode|QUICKFLEX OF LEFT HEART LEADS|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/2010|08/05/2010|||APPR|APPROVAL FOR A MODIFIED CONNECTOR RING ON QUICKFLEX MODEL 1156T AND 1158T LEFT HEART LEADS.
P020047|S022|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 SMALL VESSEL CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2010|08/31/2010|||APPR|APPROVAL FOR THE 2.25MM DIAMETER STENT SIZE AS PART OF THE MULTI-LINK 8 CORONARY STENT SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MULTI-LINK 8 SV CORONARY STENT SYSTEM AND IS INDICATED FOR PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25MM.
P950032|S059|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2010|02/14/2011|||APPR|APPROVAL TO USE A RAPID MICROBIAL METHOD, AS AN ALTERNATE STERILITY TESTING METHOD FOR ALL IN-PROCESS LIQUID SAMPLES CURRENTLY TESTED PER UNITED STATES PHARMACOPEIA <71>, STERILITY TESTS.
P040003|S008|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE|NRZ|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2010|08/23/2010|||APPR|APPROVAL FOR SOFTWARE CHANGES INCLUDED IN VERSION 4.24 OF THE WORK STATION SOFTWARE.
P970008|S052|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2010|08/27/2010|||APPR|APPROVAL FOR: 1) MODIFICATION OF THE RFID PROGRAMMING; 2) MODIFICATION OF THE COIL GAP MEASUREMENT; 3) ADDITION OF A COOLING SYSTEM GASKET; 4) SUBSTITUTION OF A LOCK SCREW; AND 5) SOFTWARE UPDATED TO DIFFERENTIATE CATHETER MODELS, CLOSE ERROR MESSAGES ON RESTART, AND ADD A PRECONFIGURED CONTROL UNIT PROTOCOL SETTING.
P090022|S002|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTROCULAR LENS|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/2010|08/13/2010|||APPR|APPROVAL TO AMEND THE APPROVED LABELING FOR THE SOFTEC HD IOL TO ALLOW FOR THE USE OF THE MEDICEL VISCOJECT 1.8, MODEL# LP604350 WITH THE SOFTEC HD AND SOFTEC I IOLS.
P970008|S051|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2010|07/16/2010|||OK30|CHANGE IN THE SUPPLIER OF SOLDER USED IN THE MANUFACTURE OF THE TARGIS SHORT CATHETER.
P070022|S005|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2010|07/21/2010|||OK30|ADDITION OF INCOMING INSPECTION REQUIREMENTS TO THE PLASTIC TUBING USED IN THE MATRIX MOLDING PROCESS.
P030022|S015|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2010|12/07/2010|||APPR|APPROVAL FOR A CHANGE IN THE BINDER SYSTEM FOR THE REFLECTION CERAMIC ACETABULAR HIP SYSTEM.
P050037|S024|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2010|10/31/2011|||APPR|APPROVAL FOR A NEW PRODUCT FILL VOLUME (I.E., 3.0CC).
P050052|S027|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2010|10/31/2011|||APPR|APPROVAL FOR A NEW PRODUCT FILL VOLUME (I.E., 3.0CC).
P000008|S019|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/02/2010|09/16/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010014|S027|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/02/2010|08/31/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000021|S017|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSIONS TPSA FLE REAGENT CARTRIDGE|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2010|09/02/2010|||APPR|APPROVAL FOR THE ADDITION OF A CLOT CHECK DEVICE TO THE DIMENSION EXL WITH LM SYSTEM WHEN USED WITH THE DIMENSION TPSA FLEX REAGENT CARTRIDGE.
P890003|S195|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK REMOTE HOME MONITOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2010|03/17/2011|||APPR|APPROVAL TO REDUCE THE 21-DAY SCHEDULING OF DEVICE INTERROGATION REQUIREMENT WITHIN THE DEVICE FIRMWARE, AS WELL AS LABELING MODIFICATIONS TO DISCLOSE THE EFFECTS OF THIS PROGRAMMABILITY ON THE LONGEVITY OF THE PULSE GENERATORS.
P020027|S012|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSIONS FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2010|09/02/2010|||APPR|APPROVAL FOR THE ADDITION OF A CLOT CHECK DEVICE TO THE DIMENSION EXL WITH LM SYSTEM WHEN USED WITH THE DIMENSION FPSA FLEX REAGENT CARTRIDGE.
P910023|S240|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE/CURRENT FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2010|10/20/2011|||APPR|APPROVAL FOR THE NEUTRINO 2, SHIVA, AND SHIVA 2 HIGH VOLTAGE CAPACITORS.
P090003|S005|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2010|02/03/2011|||APPR|APPROVAL FOR MULTIPLE COMPONENT-SPECIFIC MANUFACTURING PROCESS CHANGES.  THE DEVICE IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC LESIONS FOUND IN ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE DIAMETER OF 6 MM TO 10 MM.
P080006|S011|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice||N|07/06/2010|08/05/2010|||OK30|TRANSFER OF THE LASER ABLATION PROCESS, THE ADDITION OF NEW LASER ABLATION EQUIPMENT, AND CHANGES IN THE ABLATION PROCESS.
P920015|S062|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2010|08/05/2010|||OK30|NEW SILICONE MOLD FOR THE SHAFT SEAL COMPONENT.
P020026|S080|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2010|08/06/2010|||OK30|CHANGE IN OVERAGE FOR THE SPRAY COATING PROCESS.
P000025|S049|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR SYSTEM (MAESTRO COCHLER IMPLANT SYSTEM)|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2010|09/17/2010|||OK30|IMPLEMENTATION OF A QUALITY ASSURANCE INSPECTION STEP FOR THE INCOMING INSPECTION OF THE LIQUID SILICONE RUBBER.
P910023|S241|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CURRENT FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2010|08/06/2010|||OK30|USE OF ALTERNATE CLEANING EQUIPMENT.
P030054|S160|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2010|08/06/2010|||OK30|USE OF ALTERNATE CLEANING EQUIPMENT.
P030054|S159|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC/ATLAS/ PROMOTE FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2010|10/20/2011|||APPR|APPROVAL FOR THE NEUTRINO 2, SHIVA, AND SHIVA 2 HIGH VOLTAGE CAPACITORS.
P060008|S057|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/07/2010|03/01/2011|||APPR|APPROVAL FOR UPDATING THE PATIENT GUIDE INTO TWO SEPARATE DOCUMENTS (ANGIOPLASTY AND STENT EDUCATION GUIDE AND PATIENT INFORMATION GUIDE).
P900056|S101|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/17/2010|01/07/2011|||APPR|APPROVAL FOR A MATERIAL AND VENDOR CHANGE FOR THE INFUSION HOSE OF THE ROTABLATOR ROTALINK PLUS AND ROTALINK ADVANCER AND EXCHANGEABLE CATHETER.
P030022|S016|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/07/2010|07/30/2010|||APPR|APPROVAL FOR A CHANGE TO SMITH & NEPHEW SPECIFICATION M000286 IN TERMS OF THE AVERAGE VOLUME POROSITY OF THE POROUS COATING COMPLYING WITH THE AVERAGE VOLUME POROSITY OF 30% - 70%.
P010023|S004|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/07/2010|04/08/2011|||APPR|APPROVAL FOR THE CHANGE TO A DIGITAL PROCESSOR IN THE EXTERNAL INTEGRATED PROCESSOR AND COIL (IPC).  THE MAXUM DIGITAL IPC REPLACES THE ANALOG PROCESSOR WITH A STANDARD COMMERCIAL DIGITAL PROCESSOR INTENDED FOR HEARING AID USE.
P910023|S242|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CURRENT FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2010|08/06/2010|||OK30|HARDWARE CHANGES TO AN AUTOMATED TEST SYSTEM USED IN THE CAPACITOR MANUFACTURING PROCESS.
P030054|S161|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2010|08/06/2010|||OK30|HARDWARE CHANGES TO AN AUTOMATED TEST SYSTEM USED IN THE CAPACITOR MANUFACTURING PROCESS.
P820033|S006|Asahi Kasei Medical Co., Ltd.|1-105 KANDA JINBOCHO|CHIYODA-KU|TOKYO||101-8|8101|Separator for therapeutic purposes, membrane automated blood cell/plasma|PLASMAFLO OP-05W(A)|MDP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2010|08/06/2010|||OK30|ADDITION OF A SECOND PROCESS EQUIPMENT SET-UP FOR CERTAIN PROCESS STEPS IN THE MANUFACTURING OF THE FINISHED DEVICE AND REPLACEMENT OF A MOLD.
P020004|S054|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2010|08/06/2010|||OK30|ADDITION OF A MACHINE FOR ELECTROPOLISHING NITINOL WIRE.
P050006|S017|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2010|08/06/2010|||OK30|ADDITION OF A MACHINE FOR ELECTROPOLISHING NITINOL WIRE.
P040043|S035|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2010|08/06/2010|||OK30|ADDITION OF A MACHINE FOR ELECTROPOLISHING NITINOL WIRE.
P040037|S027|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2010|08/06/2010|||OK30|ADDITION OF A MACHINE FOR ELECTROPOLISHING NITINOL WIRE.
P040027|S020|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2010|08/06/2010|||OK30|ADDITION OF A MACHINE FOR ELECTROPOLISHING NITINOL WIRE.
P010014|S028|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/2010|01/07/2011|||APPR|APPROVAL FOR CHANGES TO THE PACKAGE INSERT, INCLUDING THE ADDITION OF MR CONDITIONAL LABELING AND THE ASSOCIATED MR CONDITIONS OF USE.
P840001|S158|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION SYSTEMS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2010|11/01/2010|||APPR|APPROVAL FOR CHANGES TO ELECTRICAL TEST SOFTWARE.
P960009|S089|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2010|11/01/2010|||APPR|APPROVAL FOR CHANGES TO ELECTRICAL TEST SOFTWARE.
P010012|S244|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2010|10/15/2010|||APPR|APPROVAL FOR THE ADDITION OF SECOND SOURCE DIODE SUPPLIERS (ST MICRO AND MINCO TECHNOLOGY LABS) FOR THE HCVM AND SOM USED IN THE COGNIS AND TELIGEN PULSE GENERATORS.
P960040|S224|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN PULSE GENERATORS|LWP|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|10/15/2010|||APPR|APPROVAL FOR THE ADDITION OF SECOND SOURCE DIODE SUPPLIERS (ST MICRO AND MINCO TECHNOLOGY LABS) FOR THE HCVM AND SOM USED IN THE COGNIS AND TELIGEN PULSE GENERATORS.
P980016|S252|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO, CONCERTO2 CONSULTA AND MAXIMO 2|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/08/2010|09/29/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES TO NPO-0402 MULTILAYER CERAMIC CAPACITORS (XC269 AND XC313).
P010031|S208|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO, VIRTUOSO 2, SECURA AND MAXIMO 2|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/08/2010|09/29/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES TO NPO-0402 MULTILAYER CERAMIC CAPACITORS (XC269 AND XC313).
P860004|S136|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INTRATHECAL CATHETER AND REVISION KITS|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|07/08/2010|12/15/2011|||APPR|APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES: 1) MODEL 8709SC INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR; 2) MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR; 3) MODEL 8596SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR; AND 4) MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT FOR MODEL 8709 AND MODEL 8709SC INTRATHECAL CATHETERS.
P060029|S001|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Sealant,polymerizing|ETHICON OMNEX SURGICAL SEALANT APPLICATOR AND PACKAGING|NBE|CV|Real-Time Process||N|07/09/2010|09/07/2010|||APPR|APPROVAL FOR CHANGES TO THE APPLICATOR AND PACKAGING.
P990046|S022|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT HEART VALVE & ATS OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2010|08/13/2010|||APPR|APPROVAL FOR LABELING CHANGES INCLUDING CHANGES TO THE MRI COMPATIBILITY INFORMATION.
P040024|S049|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2010|08/12/2010|||OK30|CHANGE IN FILL VOLUME FOR RESTYLANE®-L.
P050012|S027|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCON SEVEN AND SEVEN PLUS|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2010|11/16/2010|||APPR|APPROVAL FOR A REDUCTION IN STANDOFF AS WELL AS ADDITION OF SHOCK MOUNTING ON THE RECEIVER UNIT OF THE DEVICE.
P010012|S245|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2010|08/06/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE FRONT LINER COMPONENT USED ON THE TELIGEN AND COGNIS PULSE GENERATORS IN THE HYBRID ASSEMBLY AND TO REMOVE THE POLYIMIDE TAPE CURRENTLY APPLIED OVER THE ACCELEROMETER COMPONENT.
P960040|S225|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN PULSE GENERATORS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2010|08/06/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE FRONT LINER COMPONENT USED ON THE TELIGEN AND COGNIS PULSE GENERATORS IN THE HYBRID ASSEMBLY AND TO REMOVE THE POLYIMIDE TAPE CURRENTLY APPLIED OVER THE ACCELEROMETER COMPONENT.
P910023|S243|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|PROMOTE DEVICES & PROMOTE ACCEL DEVICES|NVZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/13/2010|09/09/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950022|S073|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|RIATA ST OPTIM AND RIATA STS OPTIM LEADS|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/13/2010|09/09/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030054|S162|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CURRENT + DEVICES  & CURRENT ACCEL DEVICES|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/13/2010|09/09/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910073|S085|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BSC CRV ENDOTAK LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2010|08/13/2010|||OK30|CHANGE IN THE RECEIVING INSPECTION SAMPLING PLAN FOR TRILUMEN SILICONE TUBING.
P960016|S030|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2010|08/13/2010|||OK30|REPLACEMENT OF THE RF FLARING FIXTURE WITH A THERMAL FLARING FIXTURE.
P040016|S061|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2010|08/13/2010|||OK30|CHANGE TO EQUIPMENT USED FOR SEALING THE POUCHES IN WHICH THE FINISHED DEVICES ARE PACKAGED.
P860019|S259|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2010|08/13/2010|||OK30|CHANGE TO EQUIPMENT USED FOR SEALING THE POUCHES IN WHICH THE FINISHED DEVICES ARE PACKAGED.
P950037|S084|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, external pacemaker, dual-chamber|REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS|OVJ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/14/2010|05/08/2012|||APPR|APPROVAL FOR TWO NEW FAMILIES OF TEMPORARY EXTERNAL PACEMAKER PULSE GENERATORS.  NEW FEATURES INCLUDE:  1) REDEL PACING WIRE CONNECTION ADAPTERS; 2) TRIGGER MODES VT AND SST; 3) SENSITIVITY SETTINGS UP TO 20 MV FOR THE REOCOR S MODEL; AND 3) PROGRAMMABLE AV DELAY UP TO 400 MS.  THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES REOCOR S AND REOCOR D AND IS INDICATED FOR: TEMPORARY PACING; TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK; SYMPTOMATIC SINUS BRADYCARDIA; PRE-, INTRA-, AND POSTOPERATIVE TEMPORARY STIMULATION OF PATIENTS UNDERGOING CARDIAC SURGERY; TERMINATION OF SUPRAVENTRICULAR TACHYARRHYTHMIAS; PROPHYLACTIC PACING FOR PREVENTION OF ARRHYTHMIAS; EMERGENCY PACING; AND CHECKING PACING THRESHOLDS.
P920015|S063|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD & Y ADAPTOR/TUNNELING TOOL/TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P010015|S094|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LV/CS/OTW LEADS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P010031|S209|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC SENTRY & INSYNC MAXIMO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P030036|S019|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT & SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P060039|S014|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P080006|S012|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P820003|S096|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOSABLE COVER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P830061|S053|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP/SP NOVUS LEADS/CAPSURE SENSE/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS +/+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P850089|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SPZ/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/VITATRON IMPULSE/IMPULSE II|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P890003|S196|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ECG CABLE/CAPSURE VDD LEADS/VITATRON BRILLANT S+ VDD LEADS/VITATRON LEGACY/LEGACY II/VISA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P900061|S092|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER/TRANSVENE DEFIBRILLATION LEAD/LEAD END PIN CAP/UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P930039|S040|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX NOVUS/SUREFIX LEADS/CAPSURE FIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET+/VITATRON PIROUET S+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P950024|S022|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR/BIPOLAR LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P970012|S072|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P980016|S253|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX LEAD/MAXIMO/MARQUIS/INTRINSIC/ENTRUST/VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P980050|S051|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CS-SVC TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P980035|S179|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENPULSE/KAPPA 700/800/900/ADAPTA/SIGMA/RELIA/SENSIA/VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P990013|S028|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/26/2010|||OK30|CHANGE TO THE ALUMINUM CRIMP CAPS USED AS PART OF THE PACKAGING FOR THE IOLS.
P030016|S016|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENS|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/26/2010|||OK30|CHANGE TO THE ALUMINUM CRIMP CAPS USED AS PART OF THE PACKAGING FOR THE IOLS.
P920015|S064|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P010015|S095|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LV/CS LEADS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P030036|S020|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P830061|S054|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE/SP NOVUS LEADS/VITATRON CRYSTALLINE/EXCELLENCE+/PS+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P850089|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z/SP NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P890003|S197|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD LEADS/WRENCH KIT/VITATRON BRILLANT S+ VDD LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P900061|S093|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACCESSORY (UPSIZING SLEEVE)/ LEAD END PIN CAP|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P930039|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX NOVUS LEADS/SUREFIX LEAD/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P950024|S023|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR/BIPOLAR LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P980050|S052|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CS-SVC TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P930029|S024|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF MARINR/NTC/5RF MARINR/RF CONDUCTR/RF ENHANCR II/RF CONTACTR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF A NEW VERSION OF TRACEABILITY SOFTWARE.
P050023|S035|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|COROX OTW STEROID LV LEAD MONITORING (COSMO)|MRM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/18/2010|07/16/2010|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL.
P060039|S015|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P010015|S096|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN/INSYNC/INSYNC III|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P010031|S210|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/II MARQUIS/MAXIMO II/II PROTECT/III MARQUIS/SENTRY/CONEXUS ACTIVATOR||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P030036|S021|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE & ANCHORING SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P080006|S013|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P820003|S097|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOSABLE COVER/EXTERNAL PULSE GENERATORS/CABLES/ADAPTOR/SURGICAL CABLE/PATIENT SAFETY CABLES/DISPOSABLE POUCH/SEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P830061|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE/SP NOVUS/VITATRON CRYSTALINE/EXCELLENCE PS+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P850089|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP Z/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE SS+/IMPULSE II|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P980016|S254|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P980035|S180|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTOR/AT500/ENPULSE/ENRHYTHM/KAPPA 600/650/700/800/900/RELIA/SENSIA/VERSA/SIGMA/PATIENT ACTIVATOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P980050|S053|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF/GEM III AT/CS-SVC TRANSVENE LEAD/INCHECK PATIENT ASSISTANT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P990001|S073|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DA+ C-SERIES & DA+ T-SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P890003|S198|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE/BRILLIANT S+ VDD LEADS/PRODIGY SR/WRENCH KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA/PACING SYSTEM ANALYZER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P900061|S094|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P920015|S065|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/QUATTRO SECURE/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P930029|S025|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF MARINR/RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II/ RF CONTACTR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P930039|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX/CAPSUREFIX NOVUS/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P950024|S024|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P970012|S073|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR/ REMOTE ASSISTANT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR INCOMING INSPECTION DATA.
P960040|S226|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VENTAK PRIZM DR/VR/VITALITY/CONFIENT/TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|REVISION OF INSPECTION PROCEDURES FOR CERAMIC CAPACITORS, CERAMIC NETWORKS, AND CERAMIC CAPACITOR ARRAYS.
P910077|S106|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX & VENTAK MINI I-IV|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|REVISION OF INSPECTION PROCEDURES FOR CERAMIC CAPACITORS, CERAMIC NETWORKS, AND CERAMIC CAPACITOR ARRAYS.
P940031|S068|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE PULSE GENERATOR PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|REVISION OF INSPECTION PROCEDURES FOR CERAMIC CAPACITORS, CERAMIC NETWORKS, AND CERAMIC CAPACITOR ARRAYS.
P010012|S246|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY SPIRAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|REVISION OF INSPECTION PROCEDURES FOR CERAMIC CAPACITORS, CERAMIC NETWORKS, AND CERAMIC CAPACITOR ARRAYS.
P030005|S065|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2010|08/13/2010|||OK30|REVISION OF INSPECTION PROCEDURES FOR CERAMIC CAPACITORS, CERAMIC NETWORKS, AND CERAMIC CAPACITOR ARRAYS.
P060027|S027|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CRT & SITUS OTW LV|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/16/2010|09/14/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030053|S009|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE-FILLED BREAST IMPLANT|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/16/2010|09/14/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980035|S181|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2010|08/13/2010|||OK30|ADDITION OF AN AUTOMATIC OPTICAL INSPECTION (AOI) SYSTEM.
P820003|S098|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2010|08/18/2010|||OK30|CHANGES IN THE DEPANELING PROCESS FOR THE PRINTED CIRCUIT BOARD ASSEMBLIES.
P900066|S010|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN PERFLUOROPROPANE C3F8 GAS|LPO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2010|08/18/2010|||OK30|CHANGE OF THE CLEANING SOLVENT USED IN THE PERFLUOROPROPANE GAS MANUFACTURING PROCESS.
P000040|S017|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS/HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2010|08/20/2010|||OK30|QUALIFICATION OF A SECONDARY ALTERNATIVE SUPPLIER FOR TWO COMPONENTS.
P090006|S002|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/2010|02/15/2011|||APPR|APPROVAL FOR THE 120MM LENGTH COMPLETE SE VASCULAR STENT.
P950029|S054|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY DR/SR & REPLY DR/SR (V2)/ESPRIT DR/SR|NVZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2010|08/18/2010|||APPR|APPROVAL FOR ADDING A REINFORCED INSPECTION STEP TO THE MANUFACTURING PROCESS OF THE DEVICE.
P910023|S244|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CURRENT FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2010|08/13/2010|||OK30|REDUCTION IN RECEIVING INSPECTION SAMPLE SIZES FOR COMPONENTS USED IN THE MANUFACTURING OF CAPACITORS.
P030054|S163|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2010|08/13/2010|||OK30|REDUCTION IN RECEIVING INSPECTION SAMPLE SIZES FOR COMPONENTS USED IN THE MANUFACTURING OF CAPACITORS.
P910023|S245|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CURRENT FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2010|08/13/2010|||OK30|USE OF ALTERNATE INSPECTION EQUIPMENT USED IN THE MANUFACTURE OF HYBRID COMPONENTS.
P030054|S164|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2010|08/13/2010|||OK30|USE OF ALTERNATE INSPECTION EQUIPMENT USED IN THE MANUFACTURE OF HYBRID COMPONENTS.
P060002|S013|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2010|08/13/2010|||OK30|SOFTWARE UPGRADE AND AN IMPROVEMENT TO THE TAPE WRAPPING PROCESS.
P840001|S159|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF NEUROSTIMULATORS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/2010|04/22/2011|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE L283 MULTI-FUNCTION INTEGRATED CIRCUIT CONTAINED IN THE NEUROSTIMULATORS OF THE DEVICE.
P960009|S090|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/2010|04/22/2011|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE L283 MULTI-FUNCTION INTEGRATED CIRCUIT CONTAINED IN THE NEUROSTIMULATORS OF THE DEVICES.
P010030|S021|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2010|01/10/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN PITTSBURGH, PENNSYLVANIA.
P960016|S031|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2010|08/13/2010|||OK30|CHANGE TO THE WIRE-TO-RING BRAZING PROCESS.
P980016|S255|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA, VIRTUOSO II & MAXIMO II|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/2010|10/29/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES TO X7R-0805 MULTILAYER CERAMIC CAPACITORS (XC194 AND XC291).
P010031|S211|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CONCERTO II, CONSULTA & MAXIMO II|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/2010|10/29/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES TO X7R-0805 MULTILAYER CERAMIC CAPACITORS (XC194 AND XC291).
P980035|S182|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, RELIA, SENSIA & VERSA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/2010|10/29/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES TO X7R-0805 MULTILAYER CERAMIC CAPACITORS (XC194 AND XC291).
P050023|S036|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILIES OF ICDS & CRT-DS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2010|08/20/2010|||OK30|NEW SUPPLIER OF A COMMUNICATION COMPONENT.
N12159|S026|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL ABSORBABLE HEMOSTAT|LMG|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2010|10/27/2010|||APPR|APPROVAL FOR THE ADDITION OF A NON-WOVEN VERSION OF SURGICEL.
P990009|S030|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2010|09/03/2010|||OK30|MODIFICATION OF THE THAWING PROCESS FOR A COMPONENT OF THE DEVICE.
P860047|S024|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION)|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2010|05/04/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT LIFECORE BIOMEDICAL, LLC IN CHASKA, MINNESOTA.
P070015|S041|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2010|08/13/2010|||OK30|INCLUSION OF FILTER INTEGRITY TESTING TO THE MANUFACTURING PROCESS.
P980006|S015|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BALAFILCON A PRODUCT FAMILY|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2010|05/16/2014|||APPR|APPROVAL FOR AN ALTERNATE PACKAGING SOLUTION OF BORATE BUFFERED SALINE WITH 0.5% POLOXAMINE FOR THE BALAFILCON A CONTACT LENS PRODUCT FAMILY.
P970003|S112|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY PROGRAMMING SOFTWARE|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2010|09/17/2010|||APPR|APPROVAL FOR UPGRADING THE OPERATING SYSTEM OF THE DELL X5 HANDHELD COMPUTER.
P070015|S042|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2010|08/26/2010|||OK30|CHANGE TO STABILITY TESTING FREQUENCY.
P980016|S256|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2010|08/20/2010|||OK30|UPGRADE TO THE CAPACITORS HELIUM LEAK TEST STATION.
P010031|S212|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC SENTRY/III MARQUIS/II MARQUIS/MAXIMO/CONCERTO ICDS/CONSULTA/MAXIMO II/CONCERTO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2010|08/20/2010|||OK30|UPGRADE TO THE CAPACITORS HELIUM LEAK TEST STATION.
P980035|S183|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2010|08/25/2010|||OK30|CORRECTION TO TESTING PROCEDURES AT A COMPONENT SUPPLIER.
P990001|S074|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C & T SERIES IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2010|08/25/2010|||OK30|CORRECTION TO TESTING PROCEDURES AT A COMPONENT SUPPLIER.
P050010|S008|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC -L TOTAL DISC REPLACEMENT|MJO|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/02/2010|02/16/2011|||APPR|APPROVAL FOR MR CONDITIONAL LABELING.
P070001|S009|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC -C TOTAL DISC REPLACEMENT|MJO|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/02/2010|02/16/2011|||APPR|APPROVAL FOR MR CONDITIONAL LABELING.
P910007|S019|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ABBOTT ARCHITECT TOTAL PSA|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2010|03/22/2011|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGSNOSTICS DIVISION IN SLIGO, IRELAND.
P000014|S021|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|08/19/2010|||OK30|ADDITIONAL SUPPLIER AND AN UPDATE OF THE RAW MATERIAL DOCUMENTATION FOR THE SUPPLY OF HUMAN, DEFIBRINATED, ANTI-HBS NEGATIVE PLASMA USED TO MANUFACTURE THE DEVICE.
P910077|S107|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE COMMUNICATORS & PROGRAMMER|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|09/29/2010|||OK30|NEW SOLDERING EQUIPMENT AND SITE RELOCATION FOR PRINTED CIRCUIT BOARDS SUPPLIER.
P090018|S004|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|12/14/2010|||APPR|APPROVAL OF COMPUTER MANUFACTURING CHANGES FOR THE ESTEEM PROGRAMMER AND INTRAOPERATIVE SYSTEM ANALYZER.
P070015|S043|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|08/27/2010|||OK30|USE OF A NEW FINAL STENT CRIMPING MACHINE.
P080032|S003|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/30/2010|||OK30|ADDITION OF A NEW TEST METHOD FOR IMPEDANCE MEASUREMENT ACCURACY.
P980016|S257|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2010|08/26/2010|||OK30|CHANGE IN THE LASER RIBBON BONDING (LRB) MANUFACTURING PROCESS.
P010031|S213|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONSULTA/MAXIMO II/ CONCERTO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2010|08/26/2010|||OK30|CHANGE IN THE LASER RIBBON BONDING (LRB) MANUFACTURING PROCESS.
P960007|S019|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2010|08/25/2010|||OK30|ELIMINATING AN ASSAY USED IN THE TRANSCYTE MANUFACTURING PROCESS.
P910023|S246|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2010|09/23/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE CONNECTOR BLOCKS INCLUDING THE USE OF METAL INJECTION MOLDING (MIM) AND THE USE OF MP35N AS THE MATERIAL.
P030054|S165|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC/+/II, ATLAS/+/II, CURRENT/CURRENT+ AND PROMOTE+ FAMILY OF DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2010|09/23/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE CONNECTOR BLOCKS INCLUDING THE USE OF METAL INJECTION MOLDING (MIM) AND THE USE OF MP35N AS THE MATERIAL.
P010023|S005|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|09/10/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE CHANGE TO BIOTEST LABORATORIS, INC. IN MINNEAPOLIS, MINNESOTA.
P920047|S043|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II/BLAZER PRIME HTD ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|08/26/2010|||OK30|CHANGE IN THE APPLICATION OF THE CURRENT SHRINK TUBING PROCESS.
P020025|S024|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP/BLAZER PRIME XP ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|08/26/2010|||OK30|CHANGE IN THE APPLICATION OF THE CURRENT SHRINK TUBING PROCESS.
P900056|S102|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK ADVANCER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|08/26/2010|||OK30|ALTERNATE PROCESSING MATERIALS, AND AN ALTERNATE VENDOR USED TO MANUFACTURE A COMPONENT OF THE ROTABLATOR SERIES OF DEVICES.
P000053|S029|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|08/26/2010|||OK30|UPGRADING OF CERTAIN COMPONENTS USED IN THE INHIBIZONE (IZ) TREATMENT PROCESS.
P040003|S009|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000/2100 1.5 AND 3T|NRZ|OB|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|07/26/2010|08/09/2011|||APPR|APPROVAL FOR UPDATED LABELING INCLUDING LONG-TERM DATA FROM THE POST-APPROVAL STUDY.
P050012|S028|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN & SEVEN PLUS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/25/2010|||OK30|USE OF A SECONDARY POROUS POUCH SEALER FOR THE SEVEN SENSORS WHICH ARE COMPONENTS OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P930038|S063|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/27/2010|||OK30|ALTERNATE STERILIZATION INSPECTION METHOD.
P090007|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS  PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER|MZO|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2010|09/23/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE DEVICE LABELING TO ADD A CLAIM DEFINING THE IMMUNOASSAY CUTOFF-INDEX ABOVE WHICH SUPPLEMENTAL RECOMBINANT IMMUNOBLOT ASSAY TESTING IS NOT REQUIRED.
P930039|S043|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/27/2010|||OK30|USE OF A NEW ELECTRICAL TEST FIXTURE.
P090008|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS  PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER|MZO|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2010|09/23/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE DEVICE LABELING TO ADD A CLAIM DEFINING THE IMMUNOASSAY CUTOFF-INDEX ABOVE WHICH SUPPLEMENTAL RECOMBINANT IMMUNOBLOT ASSAY TESTING IS NOT REQUIRED.
P060002|S014|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/13/2010|||OK30|REVISED FORMULATION FOR THE ADHESIVE USED DURING MANUFACTURING.
P090009|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS  PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER|MZO|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2010|09/23/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE DEVICE LABELING TO ADD A CLAIM DEFINING THE IMMUNOASSAY CUTOFF-INDEX ABOVE WHICH SUPPLEMENTAL RECOMBINANT IMMUNOBLOT ASSAY TESTING IS NOT REQUIRED.
P990040|S012|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2010|09/27/2010|||APPR|APPROVAL FOR RELABELING AND REPACKAGING THE ETHIODIZED OIL COMPONENT TO MEET THE CURRENT CODMAN SPECIFICATION.
P980035|S184|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/27/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P980016|S258|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/27/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P970012|S074|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/27/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P990001|S075|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C & T SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/27/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P010015|S098|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P & INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/27/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P010031|S214|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2010|08/27/2010|||OK30|RELOCATION OF AN ETHYLENE OXIDE STERILIZER.
P980035|S185|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2010|08/27/2010|||OK30|OPTIMIZATION OF WELD PROCESS PARAMETERS.
P910023|S247|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2010|08/27/2010|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR A DIODE COMPONENT AND AN ORGANIC SUBSTRATE.
P030054|S166|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2010|08/27/2010|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR A DIODE COMPONENT AND AN ORGANIC SUBSTRATE.
P030047|S021|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENTS SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2010|08/27/2010|||OK30|ADDITION OF AN IN-PROCESS INSPECTION.
P020036|S018|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART/SMART CONTROL NITINOL STENT SYSTEMS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2010|08/27/2010|||OK30|ADDITION OF AN IN-PROCESS INSPECTION.
P050012|S029|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN & SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2010|08/25/2010|||OK30|CHANGE TO REDUCE THE HOLD TIME AFTER ADHESIVE IS APPLIED TO ATTACH THE ADHESIVE PATCH TO THE DISPOSABLE HOUSING FOR THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P840001|S160|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2010|08/27/2010|||OK30|CHANGES TO THE TEST SOFTWARE USED FOR ELECTRICAL TESTING OF MEDTRONIC¿S IMPLANT TABLE NEUROSTIMULATORS.
P050012|S030|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN AND SEVEN PLUS|MDS|CH|Real-Time Process||N|07/30/2010|09/09/2010|||APPR|APPROVAL FOR MODIFICATION TO THE SENSOR NEEDLE CARRIER TO REDUCE FORCE REQUIRED TO RELEASE SNAPS DURING CANNULA RETRACTION.
P960009|S091|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2010|08/27/2010|||OK30|CHANGES TO THE TEST SOFTWARE USED FOR ELECTRICAL TESTING OF MEDTRONIC¿S IMPLANT TABLE NEUROSTIMULATORS.
P990037|S031|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|VASCULAR SOLUTIONS DUETT SEALING DEVICE|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2010|09/15/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., MINNEAPOLIS, MINNESOTA TO PERFORM THE ETHYLENE OXIDE PRE-TREATMENT STEP OF THE BULK COLLAGEN COMPONENT OF THE SUBJECT DEVICE.
P050012|S031|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCON SEVEN AND SEVEN PLUS|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2010|09/09/2010|||APPR|APPROVAL FOR A CHANGE FROM A SINGLE TO FOUR-CAVITY PRODUCTION MOLD AS WELL AS THE ADDITION OF AN ALTERNATIVE GATE LOCATION FOR THE SENSOR SAFETY LOCK.
P030054|S167|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2010|10/01/2010|||APPR|APPROVAL FOR THE MERLIN PCS SOFTWARE MODEL 3330 VERSION 10.1.1.2.
P030035|S072|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2010|10/01/2010|||APPR|APPROVAL FOR THE MERLIN PCS SOFTWARE MODEL 3330 VERSION 10.1.1.2.
P030036|S022|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2010|05/05/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) LOCATED IN VILLABLA, PUERTO RICO.
P880006|S068|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2010|10/01/2010|||APPR|APPROVAL FOR THE MERLIN PCS SOFTWARE MODEL 3330 VERSION 10.1.1.2.
P880086|S192|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2010|10/01/2010|||APPR|APPROVAL FOR THE MERLIN PCS SOFTWARE MODEL 3330 VERSION 10.1.1.2.
P910023|S248|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2010|10/01/2010|||APPR|APPROVAL FOR THE MERLIN PCS SOFTWARE MODEL 3330 VERSION 10.1.1.2.
P970013|S035|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2010|10/01/2010|||APPR|APPROVAL FOR THE MERLIN PCS SOFTWARE MODEL 3330 VERSION 10.1.1.2.
P060033|S057|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/01/2010|||OK30|CHANGE TO STERILIZATION LOAD CONFIGURATION.
P040027|S021|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/01/2010|||OK30|MODIFICATION TO THE TERMINATING WIRE ATTACHMENT PROCESS.
P040027|S022|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/01/2010|||OK30|MODIFICATION OF THE PROCESS PARAMETERS FOR ONE OF THE EO STERILIZATION CYCLES.
P960042|S019|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH II PRODUCTS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/01/2010|||OK30|CHANGE TO THE POLISHING PROCESS FOR THE SLS LASER SHEATH DISTAL TIP.
P060035|S002|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|01/04/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN DELKENHEIM, GERMANY FOR THE MANUFACTURE OF ARCHITECT CORE-M REAGENT KIT, ARCHITECT CORE-M CALIBRATOR, AND ARCHITECT CORE-M CONTROLS.
P080027|S001|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/03/2010|02/18/2011|11M-0132|03/09/2011|APPR|APPROVAL FOR THE ORAQUICK HCV RAPID ANTIBODY TEST IS A SINGLE-USE IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN FINGERSTICK WHOLE BLOOD SPECIMENS AND VENIPUNCTURE WHOLE BLOOD SPECIMENS (EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, AND SODIUM CITRATE) FROM INDIVIDUALS 15 YEARS OR OLDER.  THE ORAQUICK HCV RAPID ANTIBODY TEST RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION.
P040016|S062|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) STENT DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/01/2010|||OK30|REDUCTION OF IN-PROCESS DESTRUCTIVE TESTING AND ASSOCIATED MEASUREMENTS PERFORMED ON THE BALLOON COMPONENTS OF THE DEVICES DURING THE BALLOON MOLDING OPERATION.
P060006|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/01/2010|||OK30|REDUCTION OF IN-PROCESS DESTRUCTIVE TESTING AND ASSOCIATED MEASUREMENTS PERFORMED ON THE BALLOON COMPONENTS OF THE DEVICES DURING THE BALLOON MOLDING OPERATION.
P060008|S058|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/01/2010|||OK30|REDUCTION OF IN-PROCESS DESTRUCTIVE TESTING AND ASSOCIATED MEASUREMENTS PERFORMED ON THE BALLOON COMPONENTS OF THE DEVICES DURING THE BALLOON MOLDING OPERATION.
P860019|S260|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|PTCA CATHETERS (MAVERICK2/MAVERICK/MAVERICK XL/QUANTUM/MAVERICK/APEX)|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|09/01/2010|||OK30|REDUCTION OF IN-PROCESS DESTRUCTIVE TESTING AND ASSOCIATED MEASUREMENTS PERFORMED ON THE BALLOON COMPONENTS OF THE DEVICES DURING THE BALLOON MOLDING OPERATION.
P960009|S092|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/2010|01/26/2011|||APPR|APPROVAL FOR THE ACTIVA SC IMPLANTABLE NEUROSTIMULATOR MODELS 37602 AND 37603.
P050042|S006|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ABBOTT ARCHITECT ANTI-HCV|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2010|01/04/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN DELKENHEIM, GERMANY FOR THE MANUFACTURE OF ARCHITECT ANTI-HCV REAGENT KIT, ARCHITECT ANTI-HCV CALIBRATOR, AND ARCHITECT ANTI-HCV CONTROLS.
P010030|S022|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2010|09/01/2010|||OK30|NEW TEST TEXTURE FOR THE FUNCTIONAL TESTING OF THE ELECTRODE BELT.
P050033|S009|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2010|08/25/2010|||APPR|APPROVAL FOR A QUALITY CONTROL TEST METHOD CHANGE FOR PROTEIN CONTENT DETERMINATION OF SODIUM HYALURONATE (NAHA) POWDER FROM THE CURRENT INTERNAL MODIFIED LOWRY TEST METHOD (TMS-219) TO THE MODIFIED LOWRY TEST METHOD IN THE EUROPEAN PHARMACOPOEIA (EP) SODIUM HYALURONATE MONOGRAPH.
P050012|S032|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN & SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2010|08/25/2010|||OK30|CHANGE TO THE MANUFACTURE OF THE DEXCOM SEVEN AND SEVEN PLUS SYSTEM RECEIVER TO IMPROVE THE MANUFACTURING CONSISTENCY OF THE RECEIVER COMPONENT OF THE DEVICE.
P070015|S044|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2010|09/02/2010|||OK30|CHANGE IN THE NUMBER OF STENTS POOLED FOR ANALYTICAL RELEASE TESTING.
P030017|S107|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2010|09/03/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR CERTAIN COMPONENTS.
P060030|S012|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice||N|08/05/2010|08/30/2010|||OK30|SCALE-UP OF A MANUFACTURING PROCESS.
P050028|S008|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS AMPLIPREP/COBAS TAQMAN HBV TEST||MI|30-Day Notice||N|08/05/2010|08/30/2010|||OK30|SCALE-UP OF A MANUFACTURING PROCESS.
P030005|S067|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2010|04/08/2011|||APPR|APPROVAL FOR THE ADDITION OF A RECEIVING INSPECTION STEP FOR SETSCREWS ON HEADER COMPONENTS.
P010012|S247|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE PULSE GENERATOR, PACEMAKER|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2010|04/08/2011|||APPR|APPROVAL FOR THE ADDITION OF A RECEIVING INSPECTION STEP FOR SETSCREWS ON HEADER COMPONENTS.
P960040|S227|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2010|04/08/2011|||APPR|APPROVAL FOR THE ADDITION OF A RECEIVING INSPECTION STEP FOR SETSCREWS ON HEADER COMPONENTS.
P030047|S022|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE OTW/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2010|09/02/2010|||OK30|DISCONTINUANCE OF A FINAL PACKAGING INSPECTION.
P020036|S019|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART NITINOL STENT & SMART CONTROL NITINOL STENT SYSTEMS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2010|09/02/2010|||OK30|DISCONTINUANCE OF A FINAL PACKAGING INSPECTION.
P030005|S068|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|H120 & H125 CONTAK RENEWAL TR IS-1|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|09/03/2010|||OK30|CHANGES TO TEST SOFTWARE USED TO PERFORM ELECTRICAL TESTING OF INTEGRATED CIRCUITS USED IN PULSE GENERATORS.
P010012|S248|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE PULSE GENERATOR, PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|09/03/2010|||OK30|CHANGES TO TEST SOFTWARE USED TO PERFORM ELECTRICAL TESTING OF INTEGRATED CIRCUITS USED IN PULSE GENERATORS.
P960040|S228|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|09/03/2010|||OK30|CHANGES TO TEST SOFTWARE USED TO PERFORM ELECTRICAL TESTING OF INTEGRATED CIRCUITS USED IN PULSE GENERATORS.
P960040|S229|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|09/02/2010|||OK30|CHANGE TO THE SUPPLIED PIN LENGTH AND WELDING PROCESS USED IN THE ANODE ASSEMBLY MANUFACTURING PROCESS.
P010012|S249|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE PULSE GENERATOR, PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|09/02/2010|||OK30|CHANGE TO THE SUPPLIED PIN LENGTH AND WELDING PROCESS USED IN THE ANODE ASSEMBLY MANUFACTURING PROCESS.
P010019|S018|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|09/02/2010|||OK30|SHELF LIFE EXTENSION FOR CONTACT LENS MATERIAL FORMULATIONS.
P950021|S012|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ADVIA CENTAUR PSA ASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|08/30/2010|||OK30|IMPLEMENTATION OF AN AUTOMATED PROCESS FOR MAKING A COMPONENT THAT IS COMMON TO THE PSA AND CPSA ASSAYS.
P990055|S013|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ADVIA CENTAUR CPSA ASSAY|NAF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|08/30/2010|||OK30|IMPLEMENTATION OF AN AUTOMATED PROCESS FOR MAKING A COMPONENT THAT IS COMMON TO THE PSA AND CPSA ASSAYS.
P000044|S024|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR; HBSAG CONFIRMATORY KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|08/30/2010|||OK30|USE OF AN ADDITIONAL SUPPLIER OF THE MATERIAL USED AS MOUSE MONOCLONAL ANTI-HBS ANTIBODY AND UPDATE OF THE RAW MATERIAL OF THE MOUSE MONOCLONAL ANTI-HBS ANTIBODY AND MANUFACTURING DOCUMENTATION OF THE VITROS HBSAG CONJUGATE REAGENT.
P970021|S029|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2010|01/19/2011|||APPR|APPROVAL FOR A CHANGE IN A COMPONENT SUPPLIER.
P090018|S005|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|09/08/2010|||OK30|CHANGE THE MANUFACTURE OF THE EAR INSERT ASSEMBLY AND MICROPHONE ASSEMBLY.
P860019|S261|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|MAVERICK2 MONORAIL PTCA DILATATION CATHETER|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|09/08/2010|||OK30|ALTERNATE STERILIZATION CYCLE TO BE USED AT ISOTRON, TULLAMORE, IRELAND.
P010019|S019|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|09/08/2010|||OK30|CHANGE TO ELIMINATE THE STAGING/HOLD TIME FOR THE DEVICE.
P980007|S011|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|03/31/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION, SLIGO, IRELAND.
P860004|S137|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP MODEL 8637|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|09/01/2010|||OK30|CHANGE TO LENGTHEN THE TIME FOR MEASURING THE ALARM OUTPUT OF THE ¿ALARM TEST¿ OF THE DEVICE.
P020036|S020|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART & SMART CONTROL NITINOL STENT SYSTEMS|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|01/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE TEMPERATURE SET POINT IN YOUR SUB- ASSEMBLY PROCESS.
P040037|S028|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|09/08/2010|||OK30|AUTOMATION OF A MANUFACTURING PROCESS.
P960040|S230|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|09/08/2010|||OK30|ADDITION OF A 100% PASS/FAIL INSPECTION FOR CAPACITORS DURING MANUFACTURING.
P010012|S250|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2010|09/08/2010|||OK30|ADDITION OF A 100% PASS/FAIL INSPECTION FOR CAPACITORS DURING MANUFACTURING.
P040020|S026|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/09/2010|||OK30|MODIFICATIONS TO THE STERILANT GAS DISTRIBUTION AND DELIVERY SYSTEMS.
P930014|S042|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF MONFOCAL & ACRYSOF TORIC POSTERIOR CHMABER INTRAOCULAR LENSES & ACRYSERT DELIVERY SYSTEM|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/09/2010|||OK30|MODIFICATIONS TO THE STERILANT GAS DISTRIBUTION AND DELIVERY SYSTEMS.
P880087|S017|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/09/2010|||OK30|MODIFICATIONS TO THE STERILANT GAS DISTRIBUTION AND DELIVERY SYSTEMS.
P840060|S035|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/09/2010|||OK30|MODIFICATIONS TO THE STERILANT GAS DISTRIBUTION AND DELIVERY SYSTEMS.
P810032|S058|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/09/2010|||OK30|MODIFICATIONS TO THE STERILANT GAS DISTRIBUTION AND DELIVERY SYSTEMS.
P060002|S015|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/08/2010|||OK30|UPGRADE TO THE MAINTENANCE MANAGEMENT SOFTWARE PROGRAM USED TO TRACK AND SCHEDULE PREVENTATIVE MAINTENANCE TALK, EQUIPMENT, AND SUPPLIES.
P860004|S138|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION SYSTEM|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|03/03/2011|||APPR|APPROVAL OF THE FOLLOWING MANUFACTURING PROCESS CHANGES RELATED TO THE BASELINE TEST OF THE IMPLANTABLE SYNCHROMED II INFUSION PUMP, MODEL 8637: 1) AUTOMATION OF THE TRANSFER OF BASELINE TEST DATA; 2) CHANGE THE DUTY CYCLE AND LOWER THE SPECIFICATION LIMIT OF THE DYNAMIC CURRENT TEST; AND 3) AN INCREASE TO THE TIME TO MEASURE THE MICRO AWAKE CURRENT.
P980035|S186|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/09/2010|||OK30|ADDITIONAL SUPPLIER FOR THE PLATING PROCESS.
P980022|S081|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2010|10/13/2010|||APPR|APPROVAL FOR A SOFTWARE CHANGE TO THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K), VERSION 2.4A.
P990064|S034|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/08/2010|||OK30|MODIFICATION TO THE CONTOUR RING AND SIZING PRESSURE.
P910073|S086|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE ENDOTAK IMPLANTABLE LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/08/2010|||OK30|CHANGE TO ACTIVATE THE PERSIST FUNCTION IN THE MANUFACTURING AUTOMATED TRACEABILITY TRACKING (MATT) SYSTEM USED DURING THE MANUFACTURING OF LEADS.
P060002|S016|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2010|09/08/2010|||OK30|UPDATES TO THE ENVIRONMENTAL STORAGE SPECIFICATIONS FOR THE RAW MATERIAL USED IN MANUFACTURING.
P970003|S113|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEMS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2010|09/10/2010|||OK30|ADDITION OF A SUPPLIER IN THE STERILIZATION PROCESS.
P840001|S161|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE ULTRA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2010|09/10/2010|||OK30|CHANGES TO THE BRAZED AND SPUTTERED FILTERED FEEDTHROUGH INSPECTION PROCESS.
P960009|S093|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2010|09/10/2010|||OK30|CHANGES TO THE BRAZED AND SPUTTERED FILTERED FEEDTHROUGH INSPECTION PROCESS.
P840001|S162|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL & SYNERGY EZ PATIENT PROGRAMMER|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2010|09/10/2010|||OK30|CHANGE TO REMOVE A CONDITIONING PROCEDURE FROM THE PATIENT PROGRAMMERS¿ MANUFACTURING PROCESSES.
P960009|S094|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACCESS THERAPY CONTROLLER & ACCESS THERAPY CONTROLLER|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2010|09/10/2010|||OK30|CHANGE TO REMOVE A CONDITIONING PROCEDURE FROM THE PATIENT PROGRAMMERS¿ MANUFACTURING PROCESSES.
P970004|S091|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM PATIENT PROGRAMMER|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2010|09/10/2010|||OK30|CHANGE TO REMOVE A CONDITIONING PROCEDURE FROM THE PATIENT PROGRAMMERS¿ MANUFACTURING PROCESSES.
P010047|S005|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2010|12/29/2010|||APPR|APPROVAL FOR THE ADDITION OF A SECOND MANUFACTURING SOURCE FOR A CRITICAL DEVICE COMPONENT.
P050018|S010|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2010|09/08/2010|||OK30|ALTERNATE SUPPLIER FOR THE NITINOL SCORING ELEMENT.
P950037|S085|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS DR/SR & PHILOS II DR/SR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2010|09/10/2010|||OK30|ALTERNATE JOINING PROCESS OF PULSE GENERATOR HOUSINGS.
P960016|S032|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2010|09/10/2010|||OK30|CHANGES TO THE LIVEWIRE TC STEERABLE CATHETER SUBASSEMBLY PROCESS.
P980049|S060|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM ICDS AND CRT-D DEVICES|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/12/2010|09/08/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES FOR LOW VOLTAGE ELECTRONIC HYBRID MODULE AND INTERCONNECTION FLEX CIRCUIT FOR PARADYM VR/DR AND CRT-D, MODELS 8250, 8550, AND 8750.
P060027|S028|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM ICDS AND CRT-D DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/12/2010|09/08/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES FOR LOW VOLTAGE ELECTRONIC HYBRID MODULE AND INTERCONNECTION FLEX CIRCUIT FOR PARADYM VR/DR AND CRT-D, MODELS 8250, 8550, AND 8750.
P080007|S004|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD ELUMINEXX VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2010|09/08/2010|||OK30|REVISED FORMULATION FOR THE ADHESIVE USED DURING MANUFACTURING.
P860019|S263|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX PTCA & NC QUANTUM APEX PTCA CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2010|09/08/2010|||OK30|CHANGES TO THE IN-PROCESS MONITORING REQUIREMENTS.
P980035|S187|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SIGMA/MEDTRONIC 350/ENRHYTHM/AT500 IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2010|09/08/2010|||OK30|CHANGE TO THE BRAZED AND SPUTTERED FILTERED FEEDTHROUGH INSPECTION PROCESS.
P990001|S076|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPGS/ C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2010|09/08/2010|||OK30|CHANGE TO THE BRAZED AND SPUTTERED FILTERED FEEDTHROUGH INSPECTION PROCESS.
P010015|S099|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2010|09/08/2010|||OK30|CHANGE TO THE BRAZED AND SPUTTERED FILTERED FEEDTHROUGH INSPECTION PROCESS.
P010012|S251|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN & RENEWAL 3 PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2010|09/14/2010|||OK30|CHANGE TO THE THERMODE BLADE WING.
P960040|S231|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2010|09/14/2010|||OK30|CHANGE TO THE THERMODE BLADE WING.
P080032|S004|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2010|02/04/2011|||APPR|APPROVAL FOR ADDING GAMMA IRRADIATION AS AN ALTERNATIVE STERILIZATION METHOD, ESTABLISHING EXPIRATION DATING FOR THAT STERILIZATION METHOD, AND ADDING STERIGENICS (HAYWARD, CALIFORNIA) AS A CONTRACT STERILIZER.
P880086|S193|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|07/25/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.
P970013|S036|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|07/25/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.
P030035|S073|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|07/25/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.
P960013|S062|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS|NVN|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|07/25/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.
P960030|S032|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|07/25/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.
P950022|S074|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|PASSIVE FIXATION SJ4 LEADS|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|07/25/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.
P030054|S168|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|07/25/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.
P950034|S033|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|09/14/2010|||OK30|ADDITION OF A NEW PROCEDURE FOR THE SEPRAFILM LABELING AND PACKAGING.
P960042|S020|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANTICS SLS II LASER SHEATH|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|09/15/2010|||OK30|REMOVAL OF A QC STEP THAT VERIFIES THE FIBER BUNDLE ALIGNMENT.
P960042|S021|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANTICS SLS II LASER SHEATH|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|09/15/2010|||OK30|CHANGE IN THE LABELING PROCESS.
P050047|S012|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|09/14/2010|||OK30|CHANGE IN THE PACKAGING PROCESS.
P060033|S058|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|09/14/2010|||OK30|ALTERNATE SYSTEM FOR MEASURING EXTRUDED TUBING.
P030009|S044|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|09/14/2010|||OK30|ALTERNATE SYSTEM FOR MEASURING EXTRUDED TUBING.
P790017|S109|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2010|09/14/2010|||OK30|ALTERNATE SYSTEM FOR MEASURING EXTRUDED TUBING.
P010030|S023|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/2010|04/19/2011|||APPR|APPROVAL FOR UPDATED BARE BOARD ARTWORK FOR USE IN THE LIFEVEST WEARABLE DEFIBRILLATOR WCD 4000.
P950009|S012|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT GS IMAGING SYSTEM|MNM|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2010|09/16/2010|||APPR|APPROVAL FOR LABELING REVISIONS REGARDING WORKLOAD CALCULATION.
P840001|S163|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2010|09/16/2010|||OK30|UPDATE OF THE SOFTWARE FOR THE LASER RIBBON BONDING (ORB) PROCESSING EQUIPMENT LOCATED AT MEDTRONIC¿S PUERTO RICO OPERATIONS COMPANY (MPROC) IN JUNCOS, PUERTO RICO.
P960009|S095|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA RC DEEP BRAIN STIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2010|09/16/2010|||OK30|UPDATE OF THE SOFTWARE FOR THE LASER RIBBON BONDING (ORB) PROCESSING EQUIPMENT LOCATED AT MEDTRONIC¿S PUERTO RICO OPERATIONS COMPANY (MPROC) IN JUNCOS, PUERTO RICO.
P990013|S029|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2010|09/16/2010|||APPR|APPROVAL FOR MODIFICATION TO THE DIRECTIONS FOR USE TO COMPLY WITH THE LATEST MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC.
P880091|S032|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|SILICON UV-ABSORBING POSTERIOR CHAMBER IOL|HQL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2010|09/16/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO COMPLY WITH THE LATEST MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC.
P030016|S017|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA|MTA|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2010|09/15/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING STATEMENT AND A MODIFICATION TO A CONTRAINDICATION.
P020004|S055|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2010|09/15/2010|||OK30|CHANGES TO THE STERILIZATION CYCLE PROCESS.
P060040|S011|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2010|09/13/2010|||APPR|APPROVAL FOR UPDATED INSTRUCTIONS FOR USE (IFU) INCLUDING POST-APPROVAL STUDY RESULTS.
P040043|S036|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2010|09/15/2010|||OK30|CHANGES TO THE STERILIZATION CYCLE PROCESS.
P050006|S018|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2010|09/15/2010|||OK30|CHANGES TO THE STERILIZATION CYCLE PROCESS.
P040037|S029|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2010|09/15/2010|||OK30|CHANGES TO THE STERILIZATION CYCLE PROCESS.
P090018|S007|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2010|09/21/2010|||OK30|CHANGES FOR THE PERSONAL PROGRAMMER.
P870072|S044|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/2010|12/09/2010|||APPR|APPROVAL FOR A NEW HEARTTOUCH MOBILE COMPUTER FOR THE THORATEC VENTRICULAR ASSIST DEVICE SYSTEM.
P990040|S013|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2010|10/08/2010|||APPR|APPROVAL TO CHANGE THE CHEMICAL COMPOSITION TESTING SUPPLIER.
P930014|S043|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|TORIC LENS BENCH WITH RENISHAW GAUGE ACRYSOF TORIC & ACRYSOF IQ INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2010|09/17/2010|||OK30|USE OF A NEW TORIC LENS BENCH GAUGE (RENISHAW).
P080029|S001|INTERVENTIONAL THERAPIES, LLC.|1 GORHAM ISLAND||WESTPORT|CT|06880||Device, hemostasis, vascular|QUICK-CLOSE VASCULAR SUTURING SYSTEM|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/18/2010|03/11/2011|||APPR|APPROVAL FOR ERGONOMIC CHANGES TO THE QUICK-CLOSE VASCULAR SUTURING SYSTEM.
P040044|S033|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX CADENCE VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/2010|10/22/2010|||APPR|APPROVAL FOR REMOVING THE INNER CARTRIDGE ASSEMBLY, REDUCING THE ADVANCER TUBE MARKERS TO ONE AND ADDING A SHUTTLE STOP FEATURE.
P960040|S232|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALITY/PRIZM/CONFIENT/TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2010|09/17/2010|||OK30|ADDITION OF HEPTANE AS A SOLVENT IN THE PULSE GENERATOR CLEANING STEP.
P010012|S252|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN/RENEWAL/COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2010|09/17/2010|||OK30|ADDITION OF HEPTANE AS A SOLVENT IN THE PULSE GENERATOR CLEANING STEP.
P030005|S069|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|RENEWAL|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2010|09/17/2010|||OK30|ADDITION OF HEPTANE AS A SOLVENT IN THE PULSE GENERATOR CLEANING STEP.
P020003|S007|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Prosthesis, testicular|TOROSA TESTICULAR PROSTHESIS|FAF|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/18/2010|11/10/2010|||APPR|APPROVAL FOR THE CHANGE OF THE SALINE FILLED TESTICULAR PROSTHESIS AND THE RE-BRANDING TO ¿TOROSA TESTICULAR PROSTHESIS¿.
P000021|S018|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2010|03/11/2011|||APPR|APPROVAL FOR SOFTWARE CHANGES (VERSION 3.1.1. TO 3.3.) AND ASSOCIATED HARDWARE CHANGES TO THE DIMENSION VISTA SYSTEM.
P020027|S013|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2010|03/11/2011|||APPR|APPROVAL FOR SOFTWARE CHANGES (VERSION 3.1.1 TO 3.3) AND ASSOCIATED HARDWARE CHANGES TO THE DIMENSION VISTA SYSTEM.
P030054|S169|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2010|12/09/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES OF THE UNIT DD HIGH VOLTAGE (HV) CAPACITOR.
P020002|S005|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP IMAGING SYSTEM LABELING|MNM|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/19/2010|09/16/2010|||APPR|APPROVAL FOR LABELING REVISIONS REGARDING WORKLOAD CALCULATION.
P910023|S249|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CURRENT FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2010|12/09/2010|||APPR|APPROVAL FOR THE DESIGN CHANGES OF THE UNIT DD HIGH VOLTAGE (HV) CAPACITOR.
P950037|S086|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS DR/SR/PHILOS II DR /SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/ENTOVIS DR PULSE GENERATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2010|09/17/2010|||OK30|NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.
P050023|S037|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX ICDS/COROX OTW UP STEROID|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2010|09/17/2010|||OK30|NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.
P000009|S041|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LEXOS/LUMOS ICDS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2010|09/17/2010|||OK30|NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.
P070008|S018|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW/STRATOS LV/LV-T|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2010|09/17/2010|||OK30|NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.
P020045|S034|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR/FREEZOR XTRA SURGICAL/FREEZOR MAX SURGICAL CATHETERS AND CRYOCONSOLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2010|09/17/2010|||OK30|ALTERNATE COMPONENTS FOR THE MANUFACTURING OF PRINTED CIRCUIT BOARD ASSEMBLIES.
P030054|S170|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Drug eluting permanent left ventricular (lv) pacemaker electrode|QUICKFLEX FAMILY OF LEFT HEART LEADS|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/20/2010|09/24/2010|||APPR|APPROVAL FOR AN INCREASE IN INNER DIAMETER OF THE STYLET STOP FEATURE OF THE ELECTRODE COMPONENT OF THE DEVICE.
P040034|S017|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2010|09/16/2010|||OK30|ADDITION OF AN ALTERNATE LAB FOR TESTING CERTAIN RAW MATERIALS.
P980022|S082|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2010|09/09/2010|||OK30|ADDITIONAL SUPPLIER OF THE MOLDED PLASTIC COMPONENTS USED IN THE MANUFACTURE OF THE PARADIGM PUMP (MMT-522, MMT-522K, MMT-523, MMT-523K).
P980022|S083|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2010|10/06/2010|||APPR|APPROVAL FOR MINOR MODIFICATION TO THE DESIGN OF THE PARADIGM REAL-TIME PUMP CASE (MODELS MMT-522, MMT-522K, MMT-523, MMT-523K) TO ALLOW FOR A ¿TWO SHOT¿ MOLDING TECHNOLOGY FOR THE MANUFACTURE OF THE MAIN CASE BY A NEW SUPPLIER.
P020030|S007|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|STELID II BTF/BJF STEROID COLLAR|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|03/15/2012|||APPR|APPROVAL FOR IMPROVING THE STEROID COLLAR MANUFACTURING PROCESS.
P040045|S015|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES/CLEAR/VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|09/24/2010|||OK30|CHANGE TO THE OXYGEN PERMEABILITY TEST METHOD TM-0534.
P060039|S016|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC ATTAIN STARFIX MODEL 4195|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/23/2010|01/13/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020011|S004|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|09/17/2010|||OK30|MODIFICATION TO THE PURIFICATION AND DESALTING PROCESSES FOR TWO CLASSES OF OLIGONUCLEOTIDES (RXL INTERMEDIATES AND PPOS), WHICH ARE COMPONENTS OF SOME REAGENTS OF THE DEVICE.
P080006|S014|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD|OJX|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/23/2010|01/13/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970027|S009|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|09/20/2010|||OK30|MODIFICATIONS TO THE QUALITY CONTROL TEST METHOD USED TO DETERMINE A SPECIFIC ATTRIBUTE OF THE AXSYM ANTI-HCV SOLUTION BASED COMPONENTS.
P860057|S070|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|10/27/2010|||OK30|EXPANSION OF CLEAN ROOM #2 AT THE CHANGI, SINGAPORE MANUFACTURING FACILITY.
P050051|S005|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|04/04/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND AND A MANUFACTURING SITE AT ABBOTT DIAGNOSTICS DIVISION, MUREX BIOTECH LIMITED IN KENT, UNITED KINGDOM.
P960004|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE/FINELINE|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|09/22/2010|||OK30|CHANGE TO THE SHELF-LIFE EXPIRATION OF POLYURETHANE TUBING FROM 36 MONTHS TO ¿INDEFINITE¿.
P960040|S233|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN HE DR/VR /CONFIENT|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|09/22/2010|||OK30|CHANGE TO THE SHELF-LIFE EXPIRATION OF POLYURETHANE TUBING FROM 36 MONTHS TO ¿INDEFINITE¿.
P010012|S253|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|09/22/2010|||OK30|CHANGE TO THE SHELF-LIFE EXPIRATION OF POLYURETHANE TUBING FROM 36 MONTHS TO ¿INDEFINITE¿.
P050046|S007|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE/SPIRAL|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2010|09/22/2010|||OK30|CHANGE TO THE SHELF-LIFE EXPIRATION OF POLYURETHANE TUBING FROM 36 MONTHS TO ¿INDEFINITE¿.
P910077|S108|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2010|09/14/2010|||APPR|APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.
P840068|S047|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA PACEMAKER SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2010|09/14/2010|||APPR|APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.
P940031|S069|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR PACEMAKER SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2010|09/14/2010|||APPR|APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.
P960040|S234|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV AICD SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2010|09/14/2010|||APPR|APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.
P010012|S254|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK CRT-D SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2010|09/14/2010|||APPR|APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.
P030005|S070|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR CRT-P SYSTEM|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/23/2010|09/14/2010|||APPR|APPROVAL FOR CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01.
P060030|S014|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2010|09/22/2010|||OK30|CHANGES TO RELEASE TESTING PROCEDURES USED IN THE CAP/CTM HCV TEST.
P050047|S013|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2010|09/24/2010|||OK30|CHANGE IN FILL VOLUME FOR THE DEVICE.
P930014|S044|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2010|09/22/2010|||OK30|CHANGE IN THE PACKAGING SYSTEM.
P040020|S027|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2010|09/22/2010|||OK30|CHANGE IN THE PACKAGING SYSTEM.
P880087|S018|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE ANTERIOR CHAMBER IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2010|09/22/2010|||OK30|CHANGE IN THE PACKAGING SYSTEM.
P840060|S036|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2010|09/22/2010|||OK30|CHANGE IN THE PACKAGING SYSTEM.
P810032|S059|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2010|09/22/2010|||OK30|CHANGE IN THE PACKAGING SYSTEM.
P000010|S017|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2010|09/23/2010|||OK30|CHANGES TO REDUCE THE BATCH SIZE FOR MANUFACTURE OF SUBSTRATE A, SUBATRATE B, STOP REAGENT AND WASH CONCENTRATE BULK SOLUTION.
P000012|S025|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HVC TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2010|09/23/2010|||OK30|CHANGES TO REDUCE THE BATCH SIZE FOR MANUFACTURE OF SUBSTRATE A, SUBATRATE B, STOP REAGENT AND WASH CONCENTRATE BULK SOLUTION.
P840062|S021|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|ORATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|Normal 180 Day Track No User Fee|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2010|12/03/2010|||APPR|APPROVAL FOR THE ADDITIONAL TRADE NAME, ORATAPE, TO THE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY PRODUCT.
P030042|S004|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CONSERVE PLUS TOTAL RESURFACING SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2010|08/08/2011|||APPR|APPROVAL FOR THE CONSERVE PLUS A-CLASS FEMORAL COMPONENT AND THE CONSERVE PLUS THICK ACETABULAR SHELL TO BE USED AS COMPONENTS OF THE DEVICE.
P010033|S017|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB GOLD IN-TUBE|NCD|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/30/2010|05/26/2011|||APPR|APPROVAL FOR REVISIONS TO THE DEVICE PACKAGE INSERT AND MARKETING BOOKLET SUBSEQUENT TO THE PUBLICATION OFTHE CDC'S UPDATED GUIDELINES FOR USING INTERFERON GAMMA RELEASE ASSAYS TO DETECT MYCOBACTERIUM TUBERCULOSIS INFECTION - UNITED STATES, 2010, IN ACCORDANCE WITH THE ORIGINAL PMA POST-APPROVAL REQUIREMENT.
P000012|S026|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2010|05/24/2011|||APPR|APPROVAL FOR ELIMINATING AURINTRICARBOXYLIC ACID (ATA) ACTIVITY TESTING IN COBAS AMPLIPREP/ COBAS AMPLICOR HCV INTERNAL CONTROL BUFFER AND SPECIMEN DILUENT BULK SOLUTIONS.
P060019|S013|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2010|12/03/2010|||APPR|APPROVAL TO CHANGE THE MATERIAL OF THE EXTENSION TUBE TO INCREASE THE TORQUE RESISTANCE OF THE EXTENSION TUBE DURING HANDLE MANIPULATION.  THE MATERIAL OF THE EXTENSION TUBE WILL BE CHANGED FROM A NON-BRAIDED PELLETHANE TO A PEBAX BRAIDED TUBE (72D).  ADDITIONALLY, THE LENGTH OF THE EXTENSION TUBE AND THE INTERNAL FLUID LUMEN TUBE WILL BE DECREASED FROM 11 CM TO 4 CM.
P050034|S001|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE|NCJ|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/30/2010|10/07/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050034|S002|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE|NCJ|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/30/2010|10/13/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060040|S012|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/30/2010|10/27/2010|||APPR|APPROVAL FOR A MODIFICATION TO THE HEARTMATE II PATIENT POWER CABLE CONNECTORS.
P960040|S235|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2010|11/17/2011|||APPR|APPROVAL FOR INCEPTA, ENERGEN. PUNCTUA AND TELIGEN ICD MODELS AND THE INCEPTA, ENERGEN. PUNCTUA AND COGNIS CRT-D MODELS AND PRM SOFTWARE APPLICATION MODEL 2868 AND PULSE GENERATOR SOFTWARE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS ICD AND CRT-D MODELS AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIASOR FOR PATIENTS WITH HEART FAILURE WHO RECEIVE STABLE OPTIMAL PHARMACOLOGICAL THERAPY: MODERATE TO SEVERE HEART FAILURE (NYHA CLASS I1I-IV) WITH EF <= 35% AND QRS DURATION >= 120 MS AND LEFT BUNDLE BRANCH BLOCK (LBBB) WITH QRS >= 130 MS, EF <= 30%, AND MILD (NYHA CLASS II) ISCHEMIC OR NONISCHEMIC HEART FAILURE OR ASYMPTOMATIC (NYHA CLASS 1) ISCHEMIC HEART FAILURE.
P010012|S255|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA AND COGNIS CRT-D|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2010|11/17/2011|||APPR|APPROVAL FOR INCEPTA, ENERGEN. PUNCTUA AND TELIGEN ICD MODELS AND THE INCEPTA, ENERGEN. PUNCTUA AND COGNIS CRT-D MODELS AND PRM SOFTWARE APPLICATION MODEL 2868 AND PULSE GENERATOR SOFTWARE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS ICD AND CRT-D MODELS AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIASOR FOR PATIENTS WITH HEART FAILURE WHO RECEIVE STABLE OPTIMAL PHARMACOLOGICAL THERAPY: MODERATE TO SEVERE HEART FAILURE (NYHA CLASS I1I-IV) WITH EF <= 35% AND QRS DURATION >= 120 MS AND LEFT BUNDLE BRANCH BLOCK (LBBB) WITH QRS >= 130 MS, EF <= 30%, AND MILD (NYHA CLASS II) ISCHEMIC OR NONISCHEMIC HEART FAILURE OR ASYMPTOMATIC (NYHA CLASS 1) ISCHEMIC HEART FAILURE.
P820003|S099|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR (EPG)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2010|12/16/2010|||APPR|APPROVAL FOR THE REPLACEMENT OF THE SOCKET WITH SOLDERING OF THE EPROM ON THE MAIN BOARD FOR THE MODEL 5388 EXTERNAL PULSE GENERATOR (EPG).
P070007|S021|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2010|10/26/2010|||APPR|APPROVAL FOR TWO NEW LONGER LENGTH PROXIMAL MAIN STENT GRAFTS, THE NEW CAPTIVIA DELIVERY SYSTEM, AND A NEW STERILIZATION SITE.
P020018|S037|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2010|06/07/2011|||APPR|APPROVAL TO ADD THE ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG TO THE EXISTING ZENITH FLEX AAA ENDOVASCULAR GRAFT PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG AND IS INDICATED FOR USE WITH THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, INCLUDING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT, OR ZENITH BRANCH ILIAC ENDOVASCULAR GRAFT, DURING EITHER A PRIMARY OR SECONDARY PROCEDURE IN PATIENTS WHO HAVE ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS. THE GRAFT IS USED IN COMBINATION WITH THESE PRODUCTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS.
P840001|S164|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (INS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2010|10/01/2010|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR THE PRINTED WIRING BOARDS (PWBS) AND MANUFACTURING CHANGES FOR PWB COMPONENTS.
P860004|S139|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED DRUG PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2010|10/01/2010|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR THE PRINTED WIRING BOARDS (PWBS) AND MANUFACTURING CHANGES FOR PWB COMPONENTS.
P960009|S096|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2010|10/01/2010|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR THE PRINTED WIRING BOARDS (PWBS) AND MANUFACTURING CHANGES FOR PWB COMPONENTS.
P970004|S092|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2010|10/01/2010|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR THE PRINTED WIRING BOARDS (PWBS) AND MANUFACTURING CHANGES FOR PWB COMPONENTS.
P930014|S045|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL|HQL|OP|Panel Track|Change Design/Components/Specifications/Material|N|08/31/2010|05/03/2011|11M-0338|05/12/2011|APPR|APPROVAL FOR THE ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SN60T6, SN60T7, SN60T8, AND SN60T9 AND ACRYSOF IQ TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SN6AT6, SN6AT7, SN6AT8 AND SN6AT9.  THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION OF RESIDUAL REFRACTIVE CYLINDER AND INCREASED SPECTACLE INDEPENDENCE FOR DISTANCE VISION.
P860003|S055|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR XTS PROCEDURAL KIT|LNR|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2010|01/25/2011|||APPR|APPROVAL FOR USE OF A NEW WELDER IN MANUFACTURING THE CENTRIFUGE BOWL.
P030005|S071|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTRAK RENEWAL TR/TR2 PULSE GENERATOR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2010|10/01/2010|||OK30|ADDITION OF A REDUNDANT DYE AND SHEAR TEST, AND AN INCREASE OF SAMPLE SIZE FOR TESTING SURGE SUPPRESSORS IN THE MANUFACTURING OF PULSE GENERATORS.
P000058|S039|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT|NEK|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2010|01/26/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN ANÞASCO, PUERTO RICO TO PERFORM POST-ALKALI TREATMENT STEPS FOR THE ABSORBABLE COLLAGEN SPONGE (ACS).
P000054|S026|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2010|01/26/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN ANÞASCO, PUERTO RICO TO PERFORM POST-ALKALI TREATMENT STEPS FOR THE ABSORBABLE COLLAGEN SPONGE (ACS).
P050053|S017|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2010|01/26/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN ANÞASCO, PUERTO RICO TO PERFORM POST-ALKALI TREATMENT STEPS FOR THE ABSORBABLE COLLAGEN SPONGE (ACS).
P040043|S037|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTESIS|MIH|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|09/02/2010|02/24/2011|||APPR|APPROVAL TO UPDATE THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE TO INCLUDE SUMMARY INFORMATION ON THE EVALUATION OF THE PHYSICIAN TRAINING PROGRAM FOR THIS DEVICE.
P070015|S045|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2010|01/14/2011|||APPR|APPROVAL FOR CERTAIN CHANGES TO THE TEST METHOD FOR DETERMINING IMPURITIES IN THE PBMA EXCIPIENT.
P070015|S046|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2010|02/03/2011|||APPR|APPROVAL FOR CHANGES TO THE TESTING PLAN FOR THE DRUG SUBSTANCE.
P920023|S027|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|AMSUROLUME ENDOPROSTHESIS|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2010|09/30/2010|||OK30|CHANGE IN A MEASUREMENT METHOD USED DURING RECEIVING/ INSPECTION.
P920023|S028|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|UROLUME ENDOPROSTHESIS|MES|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/2010|09/23/2010|||APPR|APPROVAL FOR A MODIFICATION OF SPECIFICATIONS OF THE RADIUS AND LOCATION OF THE BUMP ON THE END OF THE UROLUME ENDOPROSTHESIS OUTER TUBE.
P810031|S038|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS|LZP|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|09/03/2010|11/22/2010|||APPR|APPROVAL FOR A LABELING CHANGE TO UPDATE THE LABELING THAT WAS APPROVED UNDER PMA SUPPLEMENT P810031/S017 TO REFLECT THE ABBOTT BRANDING GUIDELINES.
P060001|S010|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2010|10/04/2010|||OK30|MANUAL TO AUTOMATED MANUFACTURING CHANGE IN THE FINISHING PROCESS.
P070015|S047|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2010|10/04/2010|||OK30|MODIFICATION TO THE BIOBURDEN TESTING FREQUENCY.
P950034|S034|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2010|10/07/2010|||OK30|NEW CLEANING SCHEDULE FOR EQUIPMENT USED IN MANUFACTURING OF THE DEVICE.
P860004|S140|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/2010|10/07/2010|||APPR|APPROVAL FOR LABELING CHANGES TO THE SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS TO INCLUDE CEPHALAD MIGRATION OF CATHETER FRAGMENTS ASPART OF THE ADVERSE EVENT SUMMARIES.
P990034|S020|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED EL/SYNCHROMED II/ISOMED PUMPS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/2010|10/07/2010|||APPR|APPROVAL TO UPDATE THE LABELING FOR THESE DEVICES TO SPECIFICALLY STATE CEPHALAD MIGRATION OF CATHETER FRAGMENTS AS PART OF THE ADVERSE EVENT SUMMARIES IN THE DEVICES¿ INFORMATION FOR PRESCRIBERS MANUALS AND USER MANUALS.
P010047|S006|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2010|10/14/2010|||OK30|ADDITION OF A SECOND SOURCE FOR HUMAN SERUM ALBUMIN.
P980018|S011|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST KIT|MVC|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/2010|02/17/2011|||APPR|APPROVAL OF THE DAKOLINK V3.1.0. SOFTWARE FOR HERCEPTEST KIT.
P070014|S018|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|09/09/2010|10/14/2010|||APPR|APPROVAL FOR A CHANGE IN LABELING THAT UPDATES THE INSTRUCTIONS FOR USE AND THE PATIENT INFORMATION BROCHURE TO INCLUDE THE MOST RECENT CLINICAL DATA UP TO 3 YEARS.
P040037|S030|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/07/2010|01/13/2011|||APPR|APPROVAL FOR THE 5, 6, 7 AND 8 MM VIABAHN 3.18/3.18H DEVICES, IN THE SAME ENDOPROSTHESIS LENGTHS CURRENTLY APPROVED FOR USE IN THE SFA.
P010030|S024|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/2010|02/18/2011|||APPR|APPROVAL FOR SOFTWARE CHANGES INCLUDING ASYSTOLE NOTIFICATION HANDLING, LOW BATTERY NOTIFICATION HANDLING, AND POWER UP RESPONSE BUTTON SEQUENCE IN ADDITION TO LABELING UPDATES RESULTING FROM THOSE CHANGES.
P890003|S200|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE IMPLANTABLE PULSE GENERATOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2010|10/08/2010|||OK30|CHANGE TO THE METHOD OF DATA ENTRY FOR CREATING PRODUCT LABELS.
P010012|S257|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2010|10/08/2010|||OK30|ADDITION OF A SUPPLIER FOR A CAPACITOR COMPONENT.
P960040|S237|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2010|10/08/2010|||OK30|ADDITION OF A SUPPLIER FOR A CAPACITOR COMPONENT.
P070022|S006|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2010|10/07/2010|||OK30|CHANGE IN THE CLASSIFICATION OF A PORTION OF A CLEANROOM.
P980022|S085|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|REAL-TIME PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2010|10/13/2010|||OK30|NEW BONDER TOOLING PROCESS.
P970003|S114|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2010|10/13/2010|||OK30|AN ALTERNATE CLEANING PROCESS FOR PRINTED CIRCUIT BOARDS.
P030017|S108|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2010|10/08/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE ANTENNA COIL COMPONENT.
P030017|S109|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2010|10/08/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE COIL LEAD FRAME COMPONENT.
P090003|S006|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2010|10/13/2010|||OK30|MODIFICATION OF A FOREIGN MATERIAL INSPECTION PROCEDURE.
P060006|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2010|10/08/2010|||OK30|ADDITION OF AN AUTOMATED STENT INSPECTION STEP.
P090003|S007|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2010|10/08/2010|||OK30|ADDITION OF AN AUTOMATED STENT INSPECTION STEP.
P070015|S048|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2010|10/12/2010|||OK30|MODIFICATION TO MANUFACTURING EQUIPMENT SETTINGS IN THE STENT FINISHING PROCESS.
P000012|S027|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2010|06/27/2011|||APPR|APPROVAL FOR CHANGES TO THE TEST METHODS 1) MAGNETIC SUSCEPTIBILITY; AND 2) SURFACE AREA OF THE TOSYLATED MAGNETIC BEADS USED BY THE VENDOR.
P040033|S016|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/14/2010|10/13/2010|||APPR|APPROVAL FOR REVISIONS TO THE PHYSICIAN AND PATIENT LABELING.
P980016|S259|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2010|10/15/2010|||OK30|CHANGE TO THE EFTE COATING INSPECTION PROCESS.
P010031|S215|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC III/II MARQUIS/INSYNC SENTRY/MAXIMO ICDS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2010|10/15/2010|||OK30|CHANGE TO THE EFTE COATING INSPECTION PROCESS.
P840001|S165|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2010|10/14/2010|||OK30|ADDITIONAL SUPPLIER FOR HYBRID COMPONENTS AND TO QUALIFY TWO SUPPLIERS TO PERFORM SURROGATE INSPECTIONS.
P960009|S097|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2010|10/14/2010|||OK30|ADDITIONAL SUPPLIER FOR HYBRID COMPONENTS AND TO QUALIFY TWO SUPPLIERS TO PERFORM SURROGATE INSPECTIONS.
P970004|S093|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2010|10/14/2010|||OK30|ADDITIONAL SUPPLIER FOR HYBRID COMPONENTS AND TO QUALIFY TWO SUPPLIERS TO PERFORM SURROGATE INSPECTIONS.
P870072|S045|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/14/2010|11/05/2010|||APPR|APPROVAL FOR INCREASING THE SERVICE INTERVAL FOR THE TLC-IIPLUS PORTABLE VAD DRIVER FROM 4500 HOURS TO 8000 HOURS.
P010023|S006|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2010|11/05/2010|||APPR|APPROVAL FOR A NEW EO STERILIZATION MANUFACTURING SITE FOR THE PACKAGED IMPLANT ASSEMBLY.
P910001|S037|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS ELCA LASER CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2010|10/15/2010|||OK30|CHANGE TO THE LABEL PRINTING PROCESS.
P050010|S009|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC -L TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2010|10/04/2011|||APPR|APPROVAL FOR A CHANGE FROM A MANUAL POLISHING PROCESS TO AN AUTOMATED POLISHING PROCESS AND THE ADDITION OF A PASSIVATION PROCESS AFTER THE PLASMA COATING PROCESS.
P020047|S023|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8TM/MULTI-LINK 8 LLTM/MULTI-LINK 8TM SV CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2010|02/03/2011|||APPR|APPROVAL FOR: 1) THE ADDITION OF SENSORS FOR MONITORING THE COATING PROCESS; AND 2) MINOR TOOLING UPGRADES.
P080014|S003|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR AND DNA EXTENSION KIT|MAQ|MI|Real-Time Process||N|09/16/2010|10/06/2010|||APPR|APPROVAL FOR SEVERAL CHANGES TO THE INVADER CALL REPORTER AND CERVISTA HPV HR SOFTWARE ON THE SEPARATE CDS WITH NEW PART NUMBERS.
P980035|S188|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2010|10/15/2010|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE BPA COMPONENT AND A CHANGE IN THE COMPONENT INSPECTION PROCESS.
P980016|S260|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2010|10/15/2010|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE BPA COMPONENT AND A CHANGE IN THE COMPONENT INSPECTION PROCESS.
P010031|S216|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2010|10/15/2010|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE BPA COMPONENT AND A CHANGE IN THE COMPONENT INSPECTION PROCESS.
P000008|S020|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/2010|10/08/2010|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE TO ADD CAUTIONARY STATEMENTS REGARDING HOW THE NEEDLE IS TO BE INSERTED INTO THE ACCESS PORT SEPTUM TO PREVENT DAMAGE TO THE ACCESS PORT.
P020047|S024|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2010|10/15/2010|||OK30|CHANGE TO THE METHODOLOGY FOR STERILIZATION DOSE AUDITS.
P970020|S057|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2010|10/15/2010|||OK30|CHANGE TO THE METHODOLOGY FOR STERILIZATION DOSE AUDITS.
P040012|S033|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2010|10/15/2010|||OK30|CHANGE TO THE METHODOLOGY FOR STERILIZATION DOSE AUDITS.
P810046|S240|ADVANCED CARDIOVASCULAR SYSTEMS, INC.|26531 YNEZ RD.||TEMECULA|CA|92591||Catheters, transluminal coronary angioplasty, percutaneous|CORONARY DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2010|10/15/2010|||OK30|CHANGE TO THE METHODOLOGY FOR STERILIZATION DOSE AUDITS.
P990027|S016|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217Z  ZYOPTIX SYSTEM|LZS|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2010|01/26/2011|||APPR|APPROVAL FOR 1) A SINGLE PART HARD DISK DRIVE;  2) AN ADDITIONAL CALIBRATION TOOL; 3) CHANGE THE SPUTTER PROCESS OF THE APERTURE; AND 4) PRODUCTION OF THE HIGH PRESSURE UNIT AND ASSOCIATED TESTING OUTSOURCED TO A NEW SUPPLIER.
P060025|S007|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|ATS 3F AORTIC BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2010|10/15/2010|||OK30|ADDITIONAL SUPPLIERS OF EQUINE TISSUE.
P980022|S086|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM: CARELINK PRO, MMT-7335 VERSION 3.0B|MDS|CH|Real-Time Process||N|09/17/2010|11/01/2010|||APPR|APPROVAL FOR A CHANGE TO THE CARELINK PRO (MMT-7335)-THERAPY MANAGEMENT SOFTWARE FOR DIABETES, FROM VERSION 3.0A TO 3.0B.
P060040|S013|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LVAS|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/2010|10/08/2010|||APPR|APPROVAL FOR REVISED OPERATOR MANUAL AND PATIENT HANDBOOK LABELING FOR THE DEVICE.
P930016|S034|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/20/2010|03/04/2011|||APPR|APPROVAL FOR WAVESCAN WAVE- FRONT SOFTWARE VERSION 3.68.
P890047|S032|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2010|05/27/2011|||APPR|APPROVAL FOR THE ADDITION OF A THIRD PACKAGING LINE FOR THE DISCOVISC®, DUOVISC® AND VISCOAT® OPHTHALMIC VISCOSURGICAL DEVICES.
P840064|S044|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT/DISCOVISC/DUOVISC|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2010|05/27/2011|||APPR|APPROVAL FOR THE ADDITION OF A THIRD PACKAGING LINE FOR THE DISCOVISC, DUOVISC,  AND VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES.
P910023|S250|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2010|10/19/2010|||OK30|EXTENSION OF PRIMER DWELL TIME FROM 24 TO 72 HOURS.
P030054|S171|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2010|10/19/2010|||OK30|EXTENSION OF PRIMER DWELL TIME FROM 24 TO 72 HOURS.
P960006|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND EXTENDABLE/RETRACTABLE ENDOCARDIAL PACING LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2010|10/20/2010|||OK30|CHANGE IN CLASSIFICATION OF THE PRODUCT FAMILIES FOR ELUTION CHARACTERIZATION SAMPLING.
P060012|S003|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2010|10/20/2010|||OK30|CHANGE TO THE MANUFACTURING PROCESS AND QUALITY CONTROL TEST METHOD FOR THE HBCAG SOLUTIO NAND THE CHANGE TO THE MANUFACTURING PROCESS FOR THE QUALIFIED RHBCAG USED IN THE AXSYM CORE 2.0 ASSAY.
P980022|S087|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2010|02/17/2011|||APPR|APPROVAL OF THE ADDITION OF AN ALTERNATE VENDOR FOR THE DYNAROLL BATTERY TUBE.
P000040|S018|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/21/2010|12/23/2010|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE PROCEDURE CONTROLLER AND GRAPHICAL USER INTERFACE.
P970003|S115|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/21/2010|11/18/2010|||APPR|APPROVAL FOR CHANGES TO BATTERY LONGEVITY DESIGN REQUIREMENTS AND RELATED LABELING OF BATTERY LONGEVITY TABLES FOR YOUR MODEL 102 AND 102R PULSE GENERATORS.
P050028|S011|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0|MKT|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2010|06/24/2011|||APPR|APPROVAL FOR AN ADDITION OF A SECOND SINTERING OVEN FOR THE MANUFACTURE OF THE BULK MAGNETIC GLASS PARTICLE (MGP) RAW MATERIAL USED IN THE PRODUCTION OF THE MPG REAGENT.
P950032|S060|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/2010|10/26/2010|||APPR|APPROVAL FOR THE INTRODUCTION OF KERATINOCYTE CELL STRAIN (HEP074) INTO THE MANUFACTURE OF APLIGRAF.
P910077|S109|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481 SOFTWARE, VERSION 1.6.|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/24/2010|11/19/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE SOFTWARE FOR THE LATITUDE INDUCTIVE COMMUNICATOR (MODEL 6481).
P010012|S258|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK & RENEWAL FAMILIES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/24/2010|11/19/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE SOFTWARE FOR THE LATITUDE INDUCTIVE COMMUNICATOR (MODEL 6481).
P960040|S238|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM AND VITALITY FAMILY|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/24/2010|11/19/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE SOFTWARE FOR THE LATITUDE INDUCTIVE COMMUNICATOR (MODEL 6481).
P860057|S071|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX|DYE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/24/2010|07/26/2011|||APPR|APPROVAL OF POST-APPROVAL STUDY PROTOCOL.
P050027|S002|KARL STORZ ENDOSCOPY-AMERICA, INC.|2151 E. GRAND AVE.||EL SEGUNDO|CA|90245||Light source system, diagnostic endoscopic|KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM|OAY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/24/2010|05/02/2012|||APPR|APPROVAL FOR HARDWARE MODIFICATIONS TO THE KARL STORZ D-LIGHT C LIGHT SOURCE.
P000010|S018|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2010|12/10/2010|||OK30|CHANGE TO REPLACE THE AMPLICON INACTIVATION TEST THAT IS CURRENTLY PERFORMED ON HCV MASTER MIXES (MMX) DURING IN-PROCESS RELEASE TESTING WITH A RECOMBINANT ENZYME URACIL-N-GLYCOSYLASE (RUNG) ACTIVITY TEST.
P000012|S028|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2010|12/10/2010|||OK30|CHANGE TO REPLACE THE AMPLICON INACTIVATION TEST THAT IS CURRENTLY PERFORMED ON HCV MASTER MIXES (MMX) DURING IN-PROCESS RELEASE TESTING WITH A RECOMBINANT ENZYME URACIL-N-GLYCOSYLASE (RUNG) ACTIVITY TEST.
P000018|S044|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH SYSTEM|MOU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/24/2010|02/23/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960016|S033|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|01/07/2011|||APPR|APPROVAL FOR THE FOLLOWING: FOR ONLY THE UNIDIRECTIONAL LIVEWIRE TC MODEL - A MODIFICATION OF THE TIP ATTACHMENT DESIGN AND CHANGE OF DISTAL TIP HEAT SHRINK TUBING MATERIAL FROM PTFE TO PTE.  FOR BOTH THE UNIDIRECTIONAL AND BIDIRECTIONAL LIVEWIRE TC MODELS - AUTOMATION OF THE EPOXY MIXING AND APPLICATION PROCESS DURING ASSEMBLY OF THE PULL WIRE, REMOVAL OF IN-PROCESS PULL TEST REQUIREMENT, INCREASE IN THE LENGTH TOLERANCE OF THE FLAT WIRE BY 0.1 INCHES AND AUTOMATION OF THE DISPENSING OF BRAZE PASTE.
P970051|S063|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2010|11/24/2010|||APPR|APPROVAL FOR MODIFICATIONS TO THE PRINTED CIRCUIT BOARD (PCB) OF THE EXTERNAL CP810 SOUND PROCESSOR.
P970003|S116|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM MODEL 250 PROGRAMMING SOFTWARE, VERSION 8.0|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2010|11/23/2010|||APPR|APPROVAL FOR DESIGN MODIFICATIONS AND ASSOCIATED LABELING CHANGES TO THE PROGRAMMING SOFTWARE, MODEL 250 PROGRAMMING SOFTWARE.
P950034|S035|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/26/2010|||OK30|CHANGES IN MANUFACTURING SITES.
P980041|S013|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/27/2010|07/01/2011|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS MADE TO THE ACCESS, SYNCHRON AND UNICEL FAMILIES OF INSTRUMENTATION PLATFORMS: 1) MODIFICATION OF THE OCCLUSION BRACKET ON THE ACCESS AND UNICEL INSTRUMENTS, B) REVISION OF THE UNICEL SYSTEM SOFTWARE, AND C) REDESIGN OF THE SAMPLE PROBE TUBE ASSEMBLY, AND D) NEW INFORMATION REGARDING POTENTIAL INTERFERENTS OF AFP MEASUREMENT DUE TO THE PRESENCE OF IMMUNOSUPPRESSANT DRUGS PRESCRIBED TO PREGNANT WOMEN.
P820060|S025|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AXSYM AFP (LN 7A48)|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/20/2010|||OK30|MODIFICATION TO A COMMON ACCESSORY FOR AXSYM ASSAYS.
P980007|S012|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|AXSYM FREE PSA (LN 3C20)|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/20/2010|||OK30|MODIFICATION TO A COMMON ACCESSORY FOR AXSYM ASSAYS.
P910007|S020|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|AXSYM TOTAL PSA (LN 3C19)|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/20/2010|||OK30|MODIFICATION TO A COMMON ACCESSORY FOR AXSYM ASSAYS.
P970027|S010|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV (LN 5C36)|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/19/2010|||OK30|MODIFICATIONS TO THE COMMON ACCESSORY FOR AXSYM HEPATITIS PRODUCTS.
P060003|S006|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM AUSAB (LN 3C74)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/19/2010|||OK30|MODIFICATIONS TO THE COMMON ACCESSORY FOR AXSYM HEPATITIS PRODUCTS.
P060012|S004|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0 (LN 8B88)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/19/2010|||OK30|MODIFICATIONS TO THE COMMON ACCESSORY FOR AXSYM HEPATITIS PRODUCTS.
P060009|S002|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT: 09VB BLDG: AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE-M 2.0 (LN 8B89)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/19/2010|||OK30|MODIFICATIONS TO THE COMMON ACCESSORY FOR AXSYM HEPATITIS PRODUCTS.
P050049|S004|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM HBSAG/CONFIRMATORY (LN 9B01)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2010|10/19/2010|||OK30|MODIFICATIONS TO THE COMMON ACCESSORY FOR AXSYM HEPATITIS PRODUCTS.
P020026|S081|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2010|03/03/2011|||APPR|APPROVAL FOR AUTOMATION OF YOUR STENT COATING PROCESS.
P820003|S100|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2010|12/07/2010|||APPR|APPROVAL OF THE REWORK AND REFURBISH MANUFACTURING PROCESSES.
P070014|S019|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2010|10/27/2010|||OK30|FORMULATION CHANGE TO A JOINING MATERIAL.
N18033|S048|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|03/10/2011|||APPR|APPROVAL TO IMPLEMENT AN ALTERNATE METHOD FOR RE-SAMPLING LENSES.
P060019|S014|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|COOL POINT TUBING SET|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|ADDITIONAL STERILIZATION CHAMBER BY THE CONTRACT STERILIZER.
P910023|S251|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|MODIFICATIONS TO THE AUTOMATED MANUFACTURING TESTS (ATE).
P030054|S172|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|MODIFICATIONS TO THE AUTOMATED MANUFACTURING TESTS (ATE).
P050010|S010|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-L TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|03/03/2011|||APPR|APPROVAL FOR A CHANGE FROM A MANUAL DEBURRING PROCESS TO AN AUTOMATED BRUSH DEBURRING PROCESS.
P050034|S003|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE|NCJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|INTRODUCTION OF AN ADDITIONAL LASER WELDING SYSTEM II.
P930039|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF CONDUCTOR COILS.
P920015|S067|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF CONDUCTOR COILS.
P010050|S011|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE 2000 HBS AG CONFIRMATORY KIT|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/2010|06/24/2011|||APPR|APPROVAL FOR AN AUTOMATED MEANS OF CONFIRMATION TESTING ON-BOARD THE IMMULITE 2000 IMMUNOASSAY ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2000 HBSAG CONFIRMATORY KIT AND IS INDICATED FOR: IMMULITE 2000 HBSAG CONFIRMATORY IS INTENDED FOR IN VITRO DIAGNOSTIC USE WITH IMMULITE 2000 ANALYZERS IN CONJUNCTION WITH THE IMMULITE 2000 HBSAG ASSAY - FOR THE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE) THAT WERE REPEATEDLY REACTIVE WHEN TESTED BY THE IMMULITE/ IMMULITE 1000 HBSAG ASSAY OR BY THE IMMULITE 2000 HBSAG ASSAY.
P890003|S203|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE IMPLANTABLE PULSE GENERATOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF CONDUCTOR COILS.
P830061|S057|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE & VITATRON CHRYSTALINE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF CONDUCTOR COILS.
P850089|S070|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/29/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF CONDUCTOR COILS.
P040025|S011|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP SYSTEM|MXM|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2010|11/23/2010|||APPR|APPROVAL FOR AN ALTERNATE POWER SUPPLY FOR THE OLYMPIC COOL-CAP SYSTEM.
P030029|S011|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA ANTI-HBS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2010|10/18/2010|||OK30|MANUFACTURING CHANGE TO ELIMINATE A QUALITY CONTROL TEST.
P040021|S013|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA EPIC/EPIC SUPRA VALVES|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|10/29/2010|||OK30|ADDITION OF A SUPPLIER OF BOVINE PERICARDIAL TISSUE.
P050023|S038|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICDS AND CRT-DS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2010|12/03/2010|||APPR|APPROVAL FOR THE ALTERNATE BATTERY FOR LUMAX 300/340 ICDS AND CDT-DS.
P810025|S029|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC & AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|01/17/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ANIKA THERAPEUTICS, INC., IN BEDFORD, MASSACHUSETTS.
P000046|S017|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II & SHELLGEL SODIUM HYALURONATE|LZP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|01/17/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ANIKA THERAPEUTICS, INC., IN BEDFORD, MASSACHUSETTS.
P960016|S034|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|SAFIRE CARDIAC ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2010|11/18/2010|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE HEADER COUPLING (FROM A MACHINED COMPONENT TO A MOLDED COMPONENT) OF THE OPTISENSE MODEL 1999 PACING AND SENSING LEAD.
P040044|S034|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2010|10/04/2011|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE MYNX VASCULAR CLOSURE DEVICE CALLED THE MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY.
P000058|S040|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|04/04/2011|||APPR|APPROVAL FOR AN ADDITIONAL SOURCE OF RECOMBINANT INSULIN.
P040021|S014|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VLAVES|LWR|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|04/01/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL IN ALAJUELA, CROATIA.
P000054|S027|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|04/04/2011|||APPR|APPROVAL FOR AN ADDITIONAL SOURCE OF RECOMBINANT INSULIN.
P050053|S018|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|04/04/2011|||APPR|APPROVAL FOR AN ADDITIONAL SOURCE OF RECOMBINANT INSULIN.
P000054|S028|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|08/03/2012|||APPR|APPROVAL FOR CHANGES TO TESTS PERFORMED AS PART OF THE ONGOING DRUG PRODUCT STABILITY PROGRAM FOR RHBMP-2 (DIBOTERMIN ALFA).
P050053|S019|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|08/03/2012|||APPR|APPROVAL FOR CHANGES TO TESTS PERFORMED AS PART OF THE ONGOING DRUG PRODUCT STABILITY PROGRAM FOR RHBMP-2 (DIBOTERMIN ALFA).
P000058|S041|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2010|08/03/2012|||APPR|APPROVAL FOR CHANGES TO TESTS PERFORMED AS PART OF THE ONGOING DRUG PRODUCT STABILITY PROGRAM FOR RHBMP-2 (DIBOTERMIN ALFA).
P060007|S004|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG AND ARCHITECT HBSAG CONFIRMATORY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|04/04/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P040012|S034|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2010|05/06/2011|11M-0343|05/12/2011|APPR|APPROVAL FOR THE RX ACCULINK CAROTID STENT SYSTEM.  THE DEVICE IS INDICATED FOR HIGH SURGICAL RISK AND STANDARD SURGICAL RISK PATIENTS AS FOLLOWS: HIGH SURGICAL RISK -THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH ABBOTT VASCULAR'S ACCUNET OR EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS), IS INDICATED FOR THE TREATMENT OF REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >= 80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM; AND PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION.  STANDARD SURGICAL RISK - THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH THE ACCUNET EMBOLIC PROTECTION SYSTEM (EPS), IS INDICATED FOR THE TREATMENT OF PATIENTS AT STANDARD RISK FOR ADVERSE EVENTS FROM CARTOID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 70% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >= 70% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR >= 60% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ANGIOGRAM; AND PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION.
P020047|S025|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8TM/MULTI-LINK 8TM LL/MULTI-LINK 8TM SV CORONARY STENT|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|10/27/2010|||OK30|ADDITION OF A SUPPLIER FOR THE DEVICE COMPONENT.
N18033|S049|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) CONTACT LENSES/CLEAR/VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|11/23/2010|||OK30|CHANGE IN A QUALITY CONTROL TEST METHOD FOR THE FINISHED VISTAKON (ETAFILCON A) CONTACT LENSES.
P030009|S045|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|10/29/2010|||OK30|MODIFICATIONS TO THE VISION ASSIST PRECISION OD WELDER.
P970051|S064|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/2010|03/26/2012|||APPR|APPROVAL FOR THE ADDITION OF A MODIFIED STRAIGHT ELECTRODE ARRAY TO THE APPROVED CI24RE IMPLANT REFERRED TO AS CI422.
P000037|S020|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|10/29/2010|||OK30|USE OF ADDITIONAL MANUFACTURING EQUIPMENT AT THE ANDERSON LANE FACILITY.
P030009|S046|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER/MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|10/27/2010|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P790017|S110|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||Catheters, transluminal coronary angioplasty, percutaneous|GRUNTZIG DILACA BALLOON DILATATION CATHETERS|LOX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|10/27/2010|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P070007|S022|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|10/27/2010|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P070027|S022|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2010|10/27/2010|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P990020|S041|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX STENT GRAFT SYSTEM|MIH|CV|30-Day Notice||N|10/01/2010|10/27/2010|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P980022|S088|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM SOF-SENSOR GLUCOSE SENSOR MMT-7003|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2010|11/09/2010|||OK30|CHANGE TO EXTEND RINSE TIME FOR THE SOF-SENSOR¿ GLUCOSE SENSOR MMT-7003.
P030009|S047|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|10/04/2010|11/01/2010|||OK30|CHANGE TO THE BALLOON SUBASSEMBLY MANUFACTURING PROCESS.
P080014|S004|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2010|10/26/2010|||OK30|CHANGES IN THE FILL VOLUME OF THE WASH BUFFER AND AN INCREASE IN SAMPLE SIZE OF THE INCOMING COMPONENTS BEING TESTED.
P960016|S035|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2010|12/07/2010|||OK30|ACCEPTANCE OF CHANGES ASSOCIATED WITH THE ELECTRODE TIP BRAZING AND MONITORING PROCESS.
P020047|S026|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2010|11/01/2010|||OK30|DISCONTINUATION OF THE QUARTERLY PYROGEN TESTING OF THE ABOVE NAMED PRE- AND POST-E-BEAM STERILIZED PRODUCTS.
P970020|S058|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2010|11/01/2010|||OK30|DISCONTINUATION OF THE QUARTERLY PYROGEN TESTING OF THE ABOVE NAMED PRE- AND POST-E-BEAM STERILIZED PRODUCTS.
P040012|S035|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2010|11/01/2010|||OK30|DISCONTINUATION OF THE QUARTERLY PYROGEN TESTING OF THE ABOVE NAMED PRE- AND POST-E-BEAM STERILIZED PRODUCTS.
P980022|S089|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/04/2010|10/13/2010|||APPR|APPROVAL FOR THE TRADE NAME CHANGE FOR PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K).  THE NEW TRADE NAME FOR THESE INSULIN PUMPS IS PARADIGM REAL-TIME REVEL INSULIN PUMP.
P050007|S027|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2010|01/07/2011|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE VESSEL LOCATOR SPRING AND SPRING RETAINER COMPONENTS.
P860004|S142|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|IMPLANTABLE INTRATHECAL CATHETERS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2010|11/03/2010|||OK30|THE ADDITION OF A CLEANING PROCESS TO THE MANUFACTURING OF INTRODUCER NEEDLES.
P970004|S095|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY/INTERSTIM II|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2010|11/02/2010|||OK30|CHANGE TO THE TEST SPECIFICATION LIMITS OF AN EXISTING FINAL FUNCTIONAL TEST.
P950037|S088|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, external pacemaker, dual-chamber|RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS|OVJ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/2010|04/20/2011|||APPR|APPROVAL FOR: 1) NEW DISPLAY SCREEN; 2) ALTERNATE BATTERY; 3) MODIFIED BATTERY CARTRIDGE; 4) MODIFIED BATTERY CONTACTS; 5) NEW FIRMWARE; 6) UPDATED SOFTWARE;  7) MODIFIED CONTROL KNOB; 8) MODIFIED CIRCUIT BOARDS; AND 9) TECHNICAL MANUAL AND DEVICE LABELING CHANGES.
P860019|S264|SCIMED LIFE SYSTEMS, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheters, transluminal coronary angioplasty, percutaneous|APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK|LOX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P020009|S066|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 MONORAIL & OTW|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P040016|S063|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P900056|S103|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE WITH WIRECLIP TORQUER|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P030025|S091|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY  STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P050019|S006|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/07/2010|12/03/2010|||APPR|APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
P920047|S044|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P980003|S024|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER & CABLE|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P020052|S007|St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY|MTE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|11/05/2010|||OK30|CHANGES TO THE WIRE-TO-RING AND ANCHOR WIRE BRAZING PROCESS.
P020025|S025|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER & CABLE/BLAZER PRIME XP CARDIAC ABLATION CATHETER|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P070027|S023|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|11/05/2010|||OK30|ADDITION OF AN ALTERNATED AUTOMATIC METHOD FOR ONE OF THE MANUFACTURING PROCESSES.
P070007|S023|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|11/05/2010|||OK30|ADDITION OF AN ALTERNATED AUTOMATIC METHOD FOR ONE OF THE MANUFACTURING PROCESSES.
P990020|S042|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|11/05/2010|||OK30|ADDITION OF AN ALTERNATED AUTOMATIC METHOD FOR ONE OF THE MANUFACTURING PROCESSES.
P810025|S030|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC/AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2010|12/01/2010|||OK30|CHANGE IN RAW MATERIAL SAMPLE PREPARATION FOR ENDOTOXIN TESTING.
P030019|S017|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2010|03/18/2011|||APPR|APPROVAL FOR THE SAMPLE PREPARATION OF RAW MATERIAL HYALURONATE ACID TO BE CHANGED FROM ITS CURRENT FORMULATION TO A MORE DILUTED TEST SAMPLE.
P000046|S018|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II & SHELLGEL SODIUM HYALURONATE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2010|12/01/2010|||OK30|CHANGE IN RAW MATERIAL SAMPLE PREPARATION FOR ENDOTOXIN TESTING.
P060006|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
P060008|S060|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2010|03/31/2011|||APPR|APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.
N18033|S050|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2010|11/10/2010|||OK30|IMPLEMENTATION OF TWO TEST METHODS FOR THE IDENTIFICATION OF RAW MATERIALS.
P040045|S017|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2010|11/10/2010|||OK30|IMPLEMENTATION OF TEST METHODS FOR THE IDENTIFICATION OF RAW MATERIALS, FOR THE VISTAKON® (SENOFILCON A) CONTACT LENS MATERIALS.
P950034|S036|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2010|12/02/2010|||OK30|UPGRADES MADE IN MANUFACTURING AREAS AND EQUIPMENT.
P970004|S096|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGE TO A NEW CONTRACT LABORATORY FOR INSPECTION PROCEDURES.
P840001|S167|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 & RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGE TO A NEW CONTRACT LABORATORY FOR INSPECTION PROCEDURES.
P960009|S099|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA RC & SOLETRA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGE TO A NEW CONTRACT LABORATORY FOR INSPECTION PROCEDURES.
P030035|S074|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/08/2010|||OK30|CHANGE IN THE ADHESIVE MIXING PROCESS USED IN PACEMAKER AND CRT-P MANUFACTURING.
P880006|S069|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/08/2010|||OK30|CHANGE IN THE ADHESIVE MIXING PROCESS USED IN PACEMAKER AND CRT-P MANUFACTURING.
P880086|S194|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/08/2010|||OK30|CHANGE IN THE ADHESIVE MIXING PROCESS USED IN PACEMAKER AND CRT-P MANUFACTURING.
P970013|S037|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/08/2010|||OK30|CHANGE IN THE ADHESIVE MIXING PROCESS USED IN PACEMAKER AND CRT-P MANUFACTURING.
P000008|S021|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|12/14/2010|||OK30|ADDITIONAL COMPONENT SUPPLIER.
P050018|S011|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|12/29/2010|||OK30|CHANGE TO INCREASE THE LOAD DENSITY FOR ETHYLENE OXIDE STERILIZATION OF THE ABOVE-STATED DEVICE.
P980016|S261|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGES TO THE INCOMING INSPECTION PROCEDURES INCLUDING THE TYPE OF ANALYSIS PERFORMED AND THE LOCATION OF THE LABORATORY PERFORMING THE ANALYSIS.
P890003|S204|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY SR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGES TO THE INCOMING INSPECTION PROCEDURES INCLUDING THE TYPE OF ANALYSIS PERFORMED AND THE LOCATION OF THE LABORATORY PERFORMING THE ANALYSIS.
P970012|S075|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGES TO THE INCOMING INSPECTION PROCEDURES INCLUDING THE TYPE OF ANALYSIS PERFORMED AND THE LOCATION OF THE LABORATORY PERFORMING THE ANALYSIS.
P980035|S189|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGES TO THE INCOMING INSPECTION PROCEDURES INCLUDING THE TYPE OF ANALYSIS PERFORMED AND THE LOCATION OF THE LABORATORY PERFORMING THE ANALYSIS.
P990001|S077|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPGS/ C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGES TO THE INCOMING INSPECTION PROCEDURES INCLUDING THE TYPE OF ANALYSIS PERFORMED AND THE LOCATION OF THE LABORATORY PERFORMING THE ANALYSIS.
P010015|S101|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGES TO THE INCOMING INSPECTION PROCEDURES INCLUDING THE TYPE OF ANALYSIS PERFORMED AND THE LOCATION OF THE LABORATORY PERFORMING THE ANALYSIS.
P010031|S217|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|CHANGES TO THE INCOMING INSPECTION PROCEDURES INCLUDING THE TYPE OF ANALYSIS PERFORMED AND THE LOCATION OF THE LABORATORY PERFORMING THE ANALYSIS.
P910001|S038|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|ADDITION OF AN ALTERNATE DI WATER SUPPLY.
P960042|S022|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2010|11/10/2010|||OK30|ADDITION OF AN ALTERNATE DI WATER SUPPLY.
N18286|S020|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM ABSORBABLE GELATIN SPONGE|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2010|10/19/2010|||APPR|APPROVAL FOR AN UPDATE TO THE LABELING TO INCLUDE THE CONTRAINDICATION: ¿DO NOT USE GELFOAM ABSORBABLE GELATIN SPONGE IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.¿
P000037|S021|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHESTIC HEART VALVE|LWQ|CV|30-Day Notice||N|10/12/2010|11/08/2010|||OK30|USE OF ADDITIONAL MANUFACTURING EQUIPMENT AT THE ANDERSON LANE FACILITY.
P060008|S061|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/12/2010|11/16/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P070015|S050|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|10/12/2010|11/08/2010|||OK30|MODIFICATION OF A DEVICE PACKAGING QUALITY CONTROL TEST.
P990040|S014|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice||N|10/12/2010|11/10/2010|||OK30|CHANGE IN: 1) SUPPLIER OF THE ETHIODIZED OIL COMPONENT OF THE N-BCA LIQUID EMBOLIC SYSTEM; AND 2) THE STERILIZATION METHOD FOR THE ETHIODIZED OIL.
P070015|S051|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2010|11/08/2010|||OK30|INCREASE OF A RETESTING INTERVAL.
P080006|S016|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LV LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2010|11/10/2010|||OK30|TRANSFER OF THE INCOMING INSPECTION ACTIVITIES TO MPROC VILLALBA AND JUNCOS FACILITIES.
P010015|S102|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LEADS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2010|11/10/2010|||OK30|TRANSFER OF THE INCOMING INSPECTION ACTIVITIES TO MPROC VILLALBA AND JUNCOS FACILITIES.
P060039|S018|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2010|11/10/2010|||OK30|TRANSFER OF THE INCOMING INSPECTION ACTIVITIES TO MPROC VILLALBA AND JUNCOS FACILITIES.
P920015|S068|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2010|11/10/2010|||OK30|TRANSFER OF THE INCOMING INSPECTION ACTIVITIES TO MPROC VILLALBA AND JUNCOS FACILITIES.
P870078|S011|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK APICAL LEFT VENTRICLE CONNECTOR|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2010|12/03/2010|||OK30|ADDITION OF A COMPONENT MANUFACTURING SUPPLIER.
P990023|S010|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2010|11/10/2010|||OK30|EXPANSION OF THE CURRENTLY APPROVED CLEANROOM (INCLUDING AN OFFICE AREA) AND THE ADDITION OF A NEW MATERIAL LOCK FOR OVD MANUFACTURING PROCESSES.
P840064|S045|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC, VISCOAT AND DUOVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2010|11/10/2010|||OK30|EXPANSION OF THE CURRENTLY APPROVED CLEANROOM (INCLUDING AN OFFICE AREA) AND THE ADDITION OF A NEW MATERIAL LOCK FOR OVD MANUFACTURING PROCESSES.
P890047|S033|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2010|11/10/2010|||OK30|EXPANSION OF THE CURRENTLY APPROVED CLEANROOM (INCLUDING AN OFFICE AREA) AND THE ADDITION OF A NEW MATERIAL LOCK FOR OVD MANUFACTURING PROCESSES.
P980016|S262|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2010|11/10/2010|||OK30|IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM USED TO IDENTIFY INTEGRATED CIRCUIT COMPONENT WAFERS AT YOUR HYBRID SUPPLIER.
P010031|S218|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2010|11/10/2010|||OK30|IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM USED TO IDENTIFY INTEGRATED CIRCUIT COMPONENT WAFERS AT YOUR HYBRID SUPPLIER.
P980035|S190|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2010|11/10/2010|||OK30|IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM USED TO IDENTIFY INTEGRATED CIRCUIT COMPONENT WAFERS AT YOUR HYBRID SUPPLIER.
P050020|S026|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2010|11/18/2010|||OK30|CHANGE TO THE NUMBER OF SENSORS DELIVERY UNITS RETAINED AS RESERVE SAMPLES.
P030026|S020|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNDIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2010|11/16/2010|||OK30|RELOCATION OF EQUIPMENT TO THE NEW MANUFACTURING SITE OF PENCOED, SOUTH WALES.
P000014|S022|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2010|11/16/2010|||OK30|COMPLETION OF THE RELOCATION OF EQUIPMENTS TO THE NEW MANUFACTURING SITE OF PENCOED, SOUTH WALES.
P030024|S013|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2010|11/16/2010|||OK30|RELOCATION OF EQUIPMENT TO THE NEW MANUFACTURING SITE OF PENCOED, SOUTH WALES.
P040021|S015|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR AND BIOCOR SUPRA VALVES|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/18/2010|12/17/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000044|S025|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2010|11/16/2010|||OK30|COMPLETION OF THE RELOCATION OF EQUIPMENTS TO THE NEW MANUFACTURING SITE OF PENCOED, SOUTH WALES.
P020027|S014|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|10/18/2010|12/13/2010|||APPR|APPROVAL TO REMOVE THE REAGENT MANAGEMENT SYSTEM FROM THE DIMENSION EXL WITH LM SYSTEM.  THE CONFIGURATION WILL BE CALLED THE DIMENSION EXL 200 SYSTEM.
P030017|S110|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2010|11/17/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE PRINTED CIRCUIT BOARD (PCB) USED IN THE ASSEMBLY OF SCS CHARGERS.
P000021|S019|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|10/18/2010|12/13/2010|||APPR|APPROVAL TO REMOVE THE REAGENT MANAGEMENT SYSTEM FROM THE DIMENSION EXL WITH LM SYSTEM.  THE CONFIGURATION WILL BE CALLED THE   DIMENSION EXL 200 SYSTEM.
P980003|S025|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/2010|04/08/2011|||APPR|APPROVAL FOR TEN DESIGN CHANGES TO THE CIRCUCOOL MODEL 8005 PUMP SYSTEM TO ADDRESS STOPPAGE AND MOTOR NOISE COMPLAINTS.  THESE CHANGES INCLUDE:  1) CHANGING A SCHOTKY DIODE FROM ON SEMICONDUCTOR¿S 1N5822 (40V MAXIMUM REVERSE VOLTAGE) TO ON SEMICONDUCTOR¿S MBR360 (60V MAXIMUM REVERSE VOLTAGE).  2) ADDITION OF A 33.3V VOLTAGE SUPPRESSOR (ON SEMICONDUCTOR P6KE39AG) ACROSS MOTOR TERMINALS AT THE MOTOR.  3) DIMENSIONAL AND TOLERANCE REVISIONS TO THE ROLLER SLEEVE, SHAFT ROTOR AND ROLLER COMPONENTS.
P030022|S017|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2010|10/14/2011|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATIVE SITE FOR THE POROUS COATING PROCESS FOR THE R3 ACETABULAR SHELLS.
P040033|S017|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING SYSTEM (BHR)|NXT|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2010|10/14/2011|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATIVE SITE FOR THE POROUS COATING PROCESS FOR THE R3 ACETABULAR SHELLS.
P990004|S019|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/2010|05/17/2011|||APPR|APPROVAL FOR THE INTRODUCTION OF A NEW HEMOSTATIC MATRIX FORMULATION, REDESIGN OF THE APPLICATION COMPONENTS, REORGANIZATION OF THE PACKAGING, AND ADDITION OF EVITHROM LYOPHILIZED THROMBIN LABELING DIRECTLY INTO THE DIRECTIONS FOR USE AS WELL AS OTHER UPDATED LABELING CHANGES.
P980040|S035|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS OPTIBLUE INTRAOCULAR LENS (IOL) MODEL ZV9003 & 1-PIECE IOL MODEL ZCB00V|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/18/2010|09/12/2012|||APPR|APPROVAL FOR THE ADDITION OF TWO ADDITIVES (I.E., 2-(3-T-BUTYL-2-HYDROXY-5-VINYL-PHENYL)-5-CHLOROBENZOTRIAZOLE) (UVAM) AND YELLOW DYE) TO THE SENSAR SOFT ACRYLIC IOLS (MODELS ZA9003 AND ZCB00).
P050033|S011|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2010|12/02/2010|||OK30|CHANGE TO THE QUALITY CONTROL TEST METHOD.
P930014|S046|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ TORIC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2010|11/23/2010|||OK30|SOFTWARE MODIFICATION TO THE MANUAL LONG (LOW DIOPTER) WET ABERROMETER.
P040020|S028|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2010|11/23/2010|||OK30|SOFTWARE MODIFICATION TO THE MANUAL LONG (LOW DIOPTER) WET ABERROMETER.
P030016|S018|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)|MTA|OP|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|10/14/2010|04/08/2011|||APPR|APPROVAL FOR A LABELING MODIFICATION TO REFLECT RESULTS FROM AN AXIAL LENGTH POST-APPROVAL STUDY PROTOCOL.
P010062|S008|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS|NUU|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2010|07/28/2014|||APPR|APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).
P020045|S035|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES|LPB|CV|Real-Time Process||N|10/20/2010|12/15/2010|||APPR|APPROVAL FOR ADDITION OF A CATHETER CONFIGURATION FILE FOR THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER TO THE CRYOCONSOLE AND RELATED MODIFICATIONS TO THE CRYOCONSOLE MANUAL.
P010032|S034|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|IMPLANTABLE PULSE GENERATOR SYSTEM|LGW|NE|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|10/20/2010|11/19/2010|||APPR|APPROVAL FOR THE ADDITION OF CRIMP RINGS IN THE STRAIN RELIEFS OF THE EXTERNAL PROGRAMMING WAND CABLE TO IMPROVE RELIABILITY.
P970031|S030|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/995CS/995MS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2010|11/19/2010|||OK30|ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P990064|S035|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2010|11/19/2010|||OK30|ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P980043|S028|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2010|11/19/2010|||OK30|ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P790007|S027|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK I MODIFIED ORIFICE VALVED CONDUIT MODEL 150|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2010|11/19/2010|||OK30|ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P870078|S012|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS, LOW POROSITY VALVED CONDUIT MODEL 105|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2010|11/19/2010|||OK30|ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P970031|S031|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|AORTIC ROOT BIOPROSTHESIS MODELS 995, 995CS, 995MS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2010|11/19/2010|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P990064|S036|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|PORCINE BIOPROSTHESIS MODELS 305, 310|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2010|11/19/2010|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P980043|S029|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS MODELS T505, T510|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2010|11/19/2010|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P790007|S028|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2010|11/19/2010|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P870078|S013|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS MODEL 105|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2010|11/19/2010|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P020009|S067|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2010|11/19/2010|||OK30|CHANGE TO PRODUCT FAMILY GROUPING FOR THE PURPOSES OF MICROBIOLOGICAL SAMPLE DESIGNATION AT THE MAPLE GROVE MANUFACTURING FACILITIES FOR PRE-STERILE PRODUCT MONITORING ACTIVITIES.
P040016|S064|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX MONORAIN & OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|10/21/2010|11/19/2010|||OK30|CHANGE TO PRODUCT FAMILY GROUPING FOR THE PURPOSES OF MICROBIOLOGICAL SAMPLE DESIGNATION AT THE MAPLE GROVE MANUFACTURING FACILITIES FOR PRE-STERILE PRODUCT MONITORING ACTIVITIES.
P010032|S035|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PADDLE LEAD KITS DFU|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/21/2010|11/17/2010|||APPR|APPROVAL FOR LABELING CHANGES THAT CLARIFY THE SURGICAL PROCEDURES USED TO IMPLANT PADDLE LEADS.
P990081|S008|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2010|11/17/2010|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS TO ENSURE THE SAFETY IN THE USE OF THE DEVICE BY: 1) ADDING A TEST TO ENSURE APPROPRIATE STAIN INTENSITY OF THE PRIMARY ANTIBODY AT THE BULK MANUFACTURING STAGES; AND 2) ADDING A QUALITY CONTROL TESTING STEPS AT THE RAW MATERIAL PRODUCTION AND BULK MANUFACTURING STAGES.
P950022|S075|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2010|12/06/2010|||APPR|APPROVAL FOR CHANGES TO THE MOLDED CONNECTOR SUBASSEMBLY FOR IMPROVED MANUFACTURABILITY AND REDUCED COST FOR THE DURATA SJ4 AND DF4 HIGH VOLTAGE LEADS.  CHANGES INCLUDE MINOR DESIGN, MATERIAL, AND MANUFACTURING PROCESS CHANGES. ADDITIONALLY, THE CURRENT APPROVED SUPPLIER, ACCELLENT, WILL BE PERFORMING ALL MANUFACTURING OPERATIONS RELATED TO THE MOLDED CONNECTOR SUBASSEMBLY.
P080014|S005|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2010|03/29/2011|||APPR|APPROVAL FOR THE INCREASE OF THE VOLUME OF THE HPV CONTROL IN CERVISTA HPV HR TEST AND LABELING CHANGES TO THE PACKAGE INSERT.
P960058|S087|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2010|12/14/2010|||APPR|APPROVAL FOR A NEW VERSION OF HEADPIECE, CALLED THE UNIVERSAL HEADPIECE (UHP).  THIS CHANGE IS BEING MADE TO PROVIDE A SINGLE HEADPIECE THAT CAN BE USED UNIVERSALLY WITH THE BODY-WORN AND BEHIND-THE-EAR SOUND PROCESSORS AS PART OF A COCHLEAR IMPLANT SYSTEM.
P890003|S205|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|IMPLANTABLE PULSE GENERATOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2010|11/19/2010|||OK30|RESTARTING THE PRODUCTION OF THE POWER SUPPLY AT A PREVIOUSLY APPROVED VENDOR SITE.
P030009|S048|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2010|11/17/2010|||OK30|ALTERNATIVE SYSTEM FOR IN-PROCESS DIMENSIONAL MEASUREMENTS.
P920015|S069|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEADS MODELS 6935/6947|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/2010|11/10/2010|||APPR|APPROVAL FOR LABELING CHANGES WARNING PHYSICIANS ABOUT OVER-RETRACTION OF THE HELIX IN THE SUBJECT LEADS.
P040024|S050|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2010|07/01/2011|||APPR|APPROVAL FOR A CHANGE IN THE COMPOSITION OF THE BIOLOGICAL INDICATOR USED FOR QUALIFICATION AND REQUALIFICATION  OF THE STEAM STERILIZATION PROCEDURE.
P970021|S030|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|06/13/2011|||APPR|APPROVAL FOR CHANGES TO THE CATHETER BALLOON MEASUREMENT PROCESS.
P840001|S168|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 IMPLANTABLE/SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS/EXTERNAL NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/24/2010|||OK30|IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM AS WELL AS A PROCESS CHANGE PERTAINING TO THE UPGRADED LABELER SYSTEM.
P960009|S100|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA/KINETRA/EXTERNAL/ACTIVA FAMILY OF NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/24/2010|||OK30|IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM AS WELL AS A PROCESS CHANGE PERTAINING TO THE UPGRADED LABELER SYSTEM.
P860004|S143|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/24/2010|||OK30|IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM AS WELL AS A PROCESS CHANGE PERTAINING TO THE UPGRADED LABELER SYSTEM.
P970004|S097|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/24/2010|||OK30|IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM AS WELL AS A PROCESS CHANGE PERTAINING TO THE UPGRADED LABELER SYSTEM.
P050020|S027|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/23/2010|||OK30|CHANGE OF THE FREESTYLE TEST STRIPS FROM A MANUAL TO AN AUTOMATIC PROCESS.
P050020|S028|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/23/2010|||OK30|NEW SHIPPING CONFIGURATION FOR THE NAVIGATOR SENSOR DELIVERY UNIT (SDU).
P050020|S029|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/23/2010|||OK30|CHANGE TO VERIFY THE PRESENCE AND LOCATION OF ADHESIVE CHANNELS IN THE FREESTYLE TEST STRIPS.
P050020|S030|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/18/2010|||OK30|MODIFICATION TO THE PROCESS FOR COATING FREESTYLE TEST STRIPS WITH MEDIATOR.
P050020|S031|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2010|11/23/2010|||OK30|CHANGE IN THE CLEANING PROCEDURE OF THE REACTORS USED TO MAKE THE NPBI MEDIATOR CHEMICAL USED IN THE FREESTYLE TEST STRIPS AND THE TIME FRAME IN WHICH THIS CLEANING PROCESS TAKES PLACE.
P010023|S007|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/2010|05/10/2012|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE WIREFORM COIL THAT IS USED TO ATTACH THE IMPLANT ASSEMBLY TO THE OSSICULAR CHAIN.
P060018|S002|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE CERVICAL DISC|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|03/24/2011|||APPR|APPROVAL FOR A CHANGE OF LOCATION OF THE ORCHID ANZON (FORMERLY ANZON COMPANY, INC.) FACILITY.
P010014|S029|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|05/03/2011|||APPR|ADDITIONAL MANUFACTURING STEPS FOR THE OXFORD® PARTIAL KNEE TWIN PEG FEMORAL COMPONENTS.
P980016|S263|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC3/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P820003|S101|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOSABLE EPG COVER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P830061|S058|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|VITATRON CRYSTALINE/VITATRON EXCELLENCE +/VITATRON EXCELLENCE PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P850089|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/STERX TIP PACING/CAPSURE Z/SP NOVUS/VITATRON IMPULSE/II/VITATRON EXCELLENCE S+/VITATRON EXCELLENCE SS+ LEAD DRUG|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P890003|S206|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P900061|S096|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ACCESSORY (UPSIZING SLEEVE)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P920015|S070|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT LEAD/TRANSVENE DF1/RV LEAD/SPRINT QUATTRO/TRANSVENE SVC/CS/SUBCUTANEOUS/TUNNELING TOOL/TRANSVENE SUBQ LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P930029|S027|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR/CONDUCTR SELF-REF/ATAKR II|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P930039|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX/NOVUS/SUREFIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATIONS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P950024|S026|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD DRUG COMBINATION|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P970012|S076|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P980035|S191|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P980050|S055|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P990001|S078|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P010015|S103|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LEAD DRUG COMBINATION 4193 & 4194/INSYNC CRT-P/INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P010031|S219|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC III/II MARQUIS CRT-D/INSYNC SENTRY/MAXIMO CRT-D/CONCERTO/CONSULTA/CONCERTO II/MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P030036|S024|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD DRUG COMBINATION/ANCHORING SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P060039|S019|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD DRUG COMBINATION|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P080006|S017|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD DRUG COMBINATION|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2010|11/23/2010|||OK30|IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
P950005|S031|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT CATHETER (4MM)|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2010|02/03/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC, JUAREZ, MEXICO.
P990025|S026|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT CATHETER (4MM)|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2010|02/03/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC, JUAREZ, MEXICO.
P010068|S021|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR RMT DS CATHETER (8MM)|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2010|02/03/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC, JUAREZ, MEXICO.
P010013|S031|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2010|03/09/2011|||APPR|APPROVAL FOR AN ANNEALING PROCESS TO THE MOLDED FRONT GRIP COMPONENT.
P040037|S031|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2010|11/24/2010|||OK30|DUPLICATE MANUFACTURING PROCESS AT THE MEDICAL CENTRAL BUILDING AT THE FLAGSTAFF FACILITY.
P090018|S008|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2010|11/23/2010|||OK30|CHANGE IN THE USB CABLE ASSEMBLY, AS WELL AS THE SUPPLIER FOR THE CABLE, TO BE USED WITH THE ESTEEM PROGRAMMER.
P950037|S089|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|IMPLANTABLE PACEMAKER PULSE GENERATOR,PACEMAKER PROGRAMMING|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/2010|04/15/2011|||APPR|APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1004.U.
P000009|S042|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/2010|04/15/2011|||APPR|APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1004.U.
P050023|S039|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/2010|04/15/2011|||APPR|APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1004.U.
P070008|S019|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/2010|04/15/2011|||APPR|APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1004.U.
P970021|S031|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2010|11/23/2010|||OK30|CHANGE THE EXTRUSION PROCESS LOCATION OF TWO COMPONENTS.
P040037|S032|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS (WITH HEPARIN BIOACTIVE SURFACE)|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2010|11/24/2010|||OK30|MODIFY A PRESSURE VESSEL USED IN THE HEPARIN COATING PROCESS.
P870024|S049|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens,contact(rigid gas permeable)-extended wear|PARAGON CRT, PARAGON CRT 100, PARAGON RG-4 RIGID GAS PERMABLE CONTACT LENS|MWL|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2010|07/28/2014|||APPR|APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).
P050031|S001|PARAGON VISION SCIENCES|947 EAST IMPALA AVE.||MESA|AZ|85204||Lens,contact(rigid gas permeable)-extended wear|PARAGON CRT LENS|MWL|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2010|07/28/2014|||APPR|APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).
P910073|S089|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE IS-1 FAMILY OF LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2010|06/14/2011|||APPR|APPROVAL FOR ACCEPTANCE OF AN ENHANCEMENT TO THE INSULATION AND TRI-LUMEN BOND PROCESS, TO INCLUDE AN UPGRADE OF THE BONDING EQUIPMENT AND ADDITIONAL ACCEPTANCE ACTIVITY INSPECTIONS TO VERIFY AN ADEQUATE BOND WHICH WILL PREVENT FLUID LEAKAGE.
P950034|S037|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/29/2010|01/19/2011|||APPR|APPROVAL FOR THE ADDITION OF A ¿QUARTER SHEET¿ CONFIGURATION TO THE SEPRAFILM ADHESION BARRIER PRODUCT LINE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ¿SEPRAFILM 4-SECTION¿ AND IS INDICATED FOR USE IN PATIENTS UNDERGOING ABDOMINAL OR PELVIC LAPAROTOMY AS AN ADJUNCT INTENDED TO REDUCE THE INCIDENCE, EXTENT AND SEVERITY OF POSTOPERATIVE ADHESIONS BETWEEN THE ABDOMINAL WALL AND THE UNDERLYING VISCERA SUCH AS OMENTUM, SMALL BOWEL, BLADDER, AND STOMACH, AND BETWEEN THE UTERUS AND SURROUNDING STRUCTURES SUCH AS TUBES AND OVARIES, LARGE BOWEL, AND BLADDER.
P980003|S026|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|MODEL 8005 CIRCUCOOL PUMP|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2010|11/19/2010|||OK30|RETROSPECTIVE OUTSOURCING OF COMPONENTS BY A SUPPLIER.
P030054|S173|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/29/2010|11/29/2011|||APPR|APPROVAL FOR PROMOTE Q MODEL CD3221-36 CRT-D, PROMOTE QUADRA MODELS CD 3245-40/40Q CRT-D, UNIFY QUADRA CRT-D MODELS CD3249-40/40Q CRT-D, QUARTET MODEL 1458Q LV LEAD, AND MODEL 3330 VERSION 12.1.1 PROGRAMMER SOFTWARE.
P030028|S002|OPHTEC BV|6421 CONGRESS AVE,SUITE 112||BOCA RATON|FL|33487||LENS, INTRAOCULAR, PHAKIC|ARTISAN MYOPIA PHAKIC IOL|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2010|11/23/2010|||OK30|SHORTENING OF ETHYLENE OXIDE DEGASSING PHASE PROCESS AND THE ADDITION OF AN ADDITIONAL STERILIZATION CONFIGURATION.
P060007|S005|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|07/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD. IN SINGAPORE.
P050051|S006|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|07/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD. IN SINGAPORE.
P080023|S003|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|07/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD. IN SINGAPORE.
P060035|S003|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|07/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD. IN SINGAPORE.
P000046|S019|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|ANIKA VISC|LZP|OP|Normal 180 Day Track No User Fee|Other Report|N|11/01/2010|01/24/2011|||APPR|APPROVAL FOR A NEW TRADE NAME.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANIKAVISC AND IS INDICATED FOR USE DURING SURGERY IN THE ANTERIOR AND POSTERIOR SEGMENTS OF THE HUMAN EYE.
P050042|S007|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|07/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD. IN SINGAPORE.
P070027|S024|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/01/2010|12/08/2010|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040020|S029|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR +3.0D ADD POWER POSTERIOR CHAMBER IOLS|MFK|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|06/30/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON LABORATORIES IRELAND LTD. IN CORK, IRELAND.
P980007|S013|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|07/26/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD IN SINGAPORE.
P910007|S021|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|07/26/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE. LTD IN SINGAPORE.
P050049|S005|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM HBSAG/CONFIRMATORY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|05/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
P070015|S052|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|12/01/2010|||OK30|REDUCTION IN PYROGEN TESTING FREQUENCY.
P060003|S007|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM AUSAB|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|05/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
P960007|S020|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE, HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE|MGR|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|06/13/2011|||APPR|APPROVAL FOR MODIFICATION OF THE AUTOMATED AND MANUAL CELL EXPANSION TRYPSINIZATION PROCESSES FOR MANUFACTURING TRANSCYTE.
P060012|S005|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|05/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
P060009|S003|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT: 09VB BLDG: AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE-M|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|05/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
P970027|S011|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|05/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
P830055|S115|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS COMPLETE TOTAL KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|03/11/2011|||APPR|APPROVAL FOR: 1) AUTOMATING ALL MILLING/GRINDING PROCESSES THAT WERE PREVIOUSLY MANUAL; 2) USE OF AN OIL-BASED COOLANT DURING MILLING/ GRINDING; AND 3) INCLUDING A NEW PROCESS ¿ MANUAL IN-PROCESS CLEAN (IPC) TO REMOVE THE OIL-BASED COOLANT AFTER MILLING.
P030009|S049|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|12/01/2010|||OK30|USAGE OF AN ALTERNATE METHOD FOR BACTERIAL ENDOTOXIN TESTING.
P060033|S059|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|12/01/2010|||OK30|USAGE OF AN ALTERNATE METHOD FOR BACTERIAL ENDOTOXIN TESTING.
P980007|S014|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|AXSYM FREE PSA|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|05/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
P910007|S022|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|AXSYM TOTAL PSA|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|05/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
P820060|S026|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AXSYM AFP|LOK|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2010|05/20/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT LABORATORIES IN NORTH CHICAGO, ILLINOIS.
P050044|S015|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2010|12/02/2010|||OK30|CHANGE IN THE FORM OF A RAW MATERIAL.
P950029|S055|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2010|12/15/2010|||OK30|CHANGE IN THE REFLOW SOLDERING AND CLEANING PROCESS.
P050011|S002|BAXTER HEALTHCARE CORP.|1620 WAUKEGAN ROAD||MCGAW PARK|IL|60085||BARRIER, ABSORABLE, ADHESION|ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)|MCN|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2010|06/17/2011|||APPR|APPROVAL TO IMPLEMENT THE ASSAY FOR DETECTING THE AMOUNT OF PEPTIDOGLYCAN (PG) IN THE ICODEXTRIN ACTIVE PHARMACEUTICAL INGREDIENT (API).
P070007|S024|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/05/2010|01/04/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010032|S036|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON IMPLANTED PULSE GENERATOR (IPG) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/23/2010|02/11/2011|||APPR|APPROVAL FOR ADDING HEAT SHRINK TUBING (HST) TO THE CONDUCTORS OF THE COAXIAL CABLE OF THE CHARGING ANTENNA WHICH IS USED WITH THE EON IPG SYSTEM.
P920023|S029|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|AMS UROLUME ENDOPROSTHESIS|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2010|12/02/2010|||OK30|MANUFACTURING PROCEDURE CHANGE PERTAINING TO AN IN-PROCESS TEST OF THE DELIVERY TOOL.
P050028|S012|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2010|12/07/2010|||OK30|CLEAN IN PLACE CYCLE CHANGES AND MINOR EQUIPMENT MODIFICATIONS FOR THE TWO LARGE SCALE BULK FORMULATION (LSBF) 10,000 L TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINE WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER FACILITY IN BRANCHBURG, NEW JERSEY.
P980022|S090|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/08/2010|01/07/2011|||APPR|APPROVAL FOR A MODIFICATION TO THE DESIGN SPECIFICATION OF THE LUMEN TUBING USED IN THE MANUFACTURING PROCESS OF THE GLUCOSE SENSOR TO ALLOW FOR LESS DIMENSIONAL VARIATION IN THE TUBING SUPPLIED BY THE TUBING VENDOR.
P990040|S015|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/08/2010|01/26/2011|||APPR|APPROVAL FOR MINOR PACKAGING AND LABELING CHANGES RELATED TO THE REPLACEMENT OF ETHODIZED OIL WITH LIPIODOL AS A DEVICE COMPONENT FOR USE IN THE TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM.
P080032|S005|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2010|06/10/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ASTHMATX, INC. IN SUNNYVALE, CALIFORNIA.
P080018|S001|CARESTREAM HEALTH, INC.|150 Verona Street||ROCHESTER|NY|14608||Full field digital,system,x-ray,mammographic|KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE|MUE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2010|12/01/2010|||APPR|APPROVAL FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM.  THE KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE TOGETHER WITH KODAK DIRECTVIEW CR MAMMOGRAPHY CASSETTE COMPRISE A DEVICE WHICH WHEN USED IN CONJUNCTION WITH A KODAK DIRECTVIEW CR SYSTEM AND A MAMMOGRAPHIC X-RAY MACHINE, GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER.  IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM BASED MAMMOGRAPHIC SYSTEMS.  THE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY A QUALIFIED PHYSICIAN USING EITHER HARD COPY FILM OR SOFT COPY DISPLAY AT A WORKSTATION.
P080015|S002|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2010|03/29/2011|||APPR|APPROVAL FOR THE INCREASE OF THE VOLUME OF THE HPV CONTROL IN CERVISTA HPB 16/18 TEST AND LABELING CHANGES TO THE PACKAGE INSERT.
P980035|S192|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTA/ENPULSE/KAPPA 600/650/700/800/900/SIGMA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2010|12/07/2010|||OK30|UPDATED INSPECTION PROCEDURE AND APPROVED RECEIVING FACILITY FOR INNER AND OUTER MOLDED SEALING RINGS COMPONENTS.
P980016|S264|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2010|12/07/2010|||OK30|UPDATED INSPECTION PROCEDURE AND APPROVED RECEIVING FACILITY FOR INNER AND OUTER MOLDED SEALING RINGS COMPONENTS.
P970012|S077|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2010|12/07/2010|||OK30|UPDATED INSPECTION PROCEDURE AND APPROVED RECEIVING FACILITY FOR INNER AND OUTER MOLDED SEALING RINGS COMPONENTS.
P950037|S090|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS DR/DR-B/SR/SR-B/DR-T/PHILOS II DR/DR-T/SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/SR/SR-T/ENTOVIS DR/DR-T/SR/SR-T|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2010|12/08/2010|||OK30|CHANGE IN SURFACE STRUCTURING PROCESS FOR THE TITANIUM HOUSINGS FOR THE IMPLANTABLE CARDIAC DEVICES.
P050023|S040|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2010|12/08/2010|||OK30|CHANGE IN SURFACE STRUCTURING PROCESS FOR THE TITANIUM HOUSINGS FOR THE IMPLANTABLE CARDIAC DEVICES.
P070008|S020|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2010|12/08/2010|||OK30|CHANGE IN SURFACE STRUCTURING PROCESS FOR THE TITANIUM HOUSINGS FOR THE IMPLANTABLE CARDIAC DEVICES.
P960016|S036|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2010|12/07/2010|||OK30|CHANGES ASSOCIATED WITH THE LIVEWIRE TC¿ CARDIAC ABLATION SYSTEM CATHETER FINAL ASSEMBLY PROCESS AND THE RING BRAZING PROCESS.
P930038|S064|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/10/2010|12/10/2010|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE.
P070027|S025|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/10/2010|04/19/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980035|S193|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|IMPLANTABLE PULSE GENERATOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/10/2010|||OK30|IMPLEMENTATION OF SPLATTER GUARD DURING CURRENT COLLECTOR WELD PROCESS.
P970003|S117|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|08/26/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYBERONICS IN AUSTIN, TEXAS.
P860003|S056|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|CELLEX PROCEDURAL KIT|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/09/2010|||OK30|CHANGE TO A COMPONENT MANUFACTURING PROCEDURE AND A CHANGE TO A TEST METHOD.
P050012|S033|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN & SEVEN PLUS SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|05/19/2011|||APPR|APPROVAL FOR A PROPOSED CHANGE TO ELIMINATE REDUNDANT POST-WINDING AND POST-SECOND-PARYLENE VISUAL INSPECTION FOR THE SENSOR COMPONENT OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM.
P000039|S037|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/12/2010|01/04/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050012|S034|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN & SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/10/2010|||OK30|MODIFICATIONS TO IMPLEMENT DATA LOGGER IMPROVEMENTS TO THE EIGHT-CHANNEL CALCHECK SYSTEM.
P030054|S174|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST JUDE MEDICAL MERLIN 3650 PROGRAMMER|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/07/2010|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TOUCH SCREEN COMPONENT.
P020004|S056|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/10/2010|||OK30|ALTERNATE PROCESS REQUIRING USE OF AUTOMATION FOR THE EPTFE WRAP COMPONENT.
P860047|S025|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT SYRINGE PRODUCT|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/2010|02/03/2012|||APPR|APPROVAL FOR AN ALTERNATE ELASTOMERIC TIP CAP MATERIAL (FM27) AND THE ADDITION OF A THREADED PLASTIC RIGID TIP CAP (PRTC) OUTER SHELL.
P860057|S072|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|07/27/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR ATEX BIAS CLOTH.
P870056|S040|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE BIOPROSTHETIC VALVES|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|07/27/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR ATEX BIAS CLOTH.
P000007|S025|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|07/27/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR ATEX BIAS CLOTH.
P980016|S265|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC30/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P820003|S102|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOSABLE EPG COVER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P830061|S059|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|VITATRON CRYSTALINE/EXCELLENCE +/PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD DRUG COMBINATION|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P850089|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE /STERX TIP PACING LEAD (VENTRICULAR/CAPSURE Z/SP NOVUS/VITATRON IMPULSE/II/EXCELLENCE S+/SS+ LEAD DRUG|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P890003|S207|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P900061|S097|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P920015|S071|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD ADAPTOR/IS-1 CONNECTOR PORT PIN PLUG KIT/Y ADAPTOR/EXTENDER KIT/SPRINT LEAD DRUG COMBINATION/TRANSVENE DF1/RV LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P930029|S028|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF /RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P930039|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX/NOVUS LEAD DRUG COMBINATION/SURE FIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATION|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P950024|S027|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD DRUG COMBINATION|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P970012|S078|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P980035|S194|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P980050|S056|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P990001|S079|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P010015|S104|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LEAD DRUG COMBINATION: 4193 & 4194 ONLY/INSYNC CRT-P/INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P010031|S220|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/II/CONCERTO/II/CONSULTA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P030036|S025|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD DRUG COMBINATION/ANCHORING SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P060039|S020|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD DRUG COMBINATION|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P080006|S018|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD DRUG COMBINATION|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/08/2010|||OK30|UPDATE TO SUPPLIER QUALITY SOFTWARE.
P970004|S098|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2010|01/11/2011|||APPR|APPROVAL FOR MINOR LABELING CHANGES TO THE MODEL 8840/ 8870 PROGRAMMING GUIDE TO MITIGATE THE EFFECTS OF THE OBSERVED LOCKING OF THE CLINICIAN PROGRAMMER¿S INFRARED COMMUNICATION PORT AFTER PRINTING PROGRAMMING SESSION REPORTS.
P960022|S007|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/15/2010|02/18/2011|||APPR|APPROVAL FOR A NAME CHANGE TO THE CURRENTLY MARKETED BAUSCH & LOMB SOFLENS 66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES.  THE PROPOSED NAME FOR THE DEVICE IS BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES.
P830055|S116|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/17/2010|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NEW JERSEY FOR GAMMA IRRADIATION.
P020004|S057|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/07/2010|||OK30|SEVERAL EQUIPMENT MODIFICATIONS TO THE STENT WINDING PROCESS.
P910023|S252|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/15/2010|||OK30|ALTERNATE ATTACHMENT PROCESS FOR THE ITMS AND L2 COIL TO THE UNITY HYBRID ASSEMBLY.
P030054|S175|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/15/2010|||OK30|ALTERNATE ATTACHMENT PROCESS FOR THE ITMS AND L2 COIL TO THE UNITY HYBRID ASSEMBLY.
P030009|S050|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|04/12/2011|||APPR|APPROVAL FOR A CHANGE TO ALLOW THE REMOVAL OF THE IN-PROCESS FUNCTIONAL TESTING COMPLETED ON THE STENTS OF DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS.
P060033|S060|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|04/12/2011|||APPR|APPROVAL FOR A CHANGE TO ALLOW THE REMOVAL OF THE IN-PROCESS FUNCTIONAL TESTING COMPLETED ON THE STENTS OF DRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS.
P980035|S195|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTA/ENPULSE/KAPPA 600/650/700/800/900/SIGMA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/13/2010|||OK30|CHANGES TO THE MOLDS USED IN THE MANUFACTURE OF THE DEVICES AND THE ADDITION OF A SECOND SUPPLIER OF THESE MOLDS.
P970012|S079|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/13/2010|||OK30|CHANGES TO THE MOLDS USED IN THE MANUFACTURE OF THE DEVICES AND THE ADDITION OF A SECOND SUPPLIER OF THESE MOLDS.
P980016|S266|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/13/2010|||OK30|CHANGES TO THE MOLDS USED IN THE MANUFACTURE OF THE DEVICES AND THE ADDITION OF A SECOND SUPPLIER OF THESE MOLDS.
P070015|S053|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V RX/PROMUS RX/XIENCE OTW/PROMUS OTW|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/07/2010|||OK30|ADDITION OF A BARCODE READER TO THE MANUFACTURING PROCESS.
P020047|S027|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 RX|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/07/2010|||OK30|ADDITION OF A BARCODE READER TO THE MANUFACTURING PROCESS.
P970020|S059|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ZETA RX/ULTRA RX/ULTRA OTW|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/07/2010|||OK30|ADDITION OF A BARCODE READER TO THE MANUFACTURING PROCESS.
P000053|S031|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/2010|05/07/2012|||APPR|APPROVAL FOR CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS.
P010020|S017|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINTER|MIP|GU|Normal 180 Day Track||N|11/15/2010|05/07/2012|||APPR|APPROVAL FOR CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS.
P020026|S082|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/2010|01/27/2012|||APPR|APPROVAL FOR THE SONIX RAPID EXCHANGE DELIVERY SYSTEM FOR THE CYPHER SIROLIMUS-ELUTING CORONARY STENT.
P020024|S030|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/15/2010|||OK30|REMOVAL OF AN ULTRASONIC COMPONENT FROM THE CLEANING PROCESS.
P040040|S015|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/15/2010|||OK30|REMOVAL OF AN ULTRASONIC COMPONENT FROM THE CLEANING PROCESS.
P000039|S038|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL & CRIBRIFORM OCCLUDERS|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2010|12/15/2010|||OK30|REMOVAL OF AN ULTRASONIC COMPONENT FROM THE CLEANING PROCESS.
P910073|S090|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE IS -1 AND RELIANCE IS-4|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2010|12/15/2010|||OK30|ADDITION OF A NEW ACCEPTANCE ACTIVITY FOR A RELIANCE IS-1 AND RELIANCE IS-4 LEAD COMPONENT.
P970008|S053|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2010|01/07/2011|||APPR|APPROVAL FOR MODIFICATION OF THE CTC ADVANCE MICROWAVE TREATMENT CATHETER TO INCORPORATE AN ADDITIONAL SET OF COOLANT OUTPUT HOLES.
P040014|S015|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2010|01/11/2011|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE TIP ELECTRODE STEM OUTER DIAMETER (OD) SO THAT THE GAP BETWEEN THE TIP ELECTRODE OD AND TUBE INSIDE DIAMETER (ID) IS REDUCED TO -0.0015¿ TO +0.0015¿ FROM -0.003¿ TO +0.003¿ FOR CONSISTENT GAP INTERFERENCE.
P060019|S015|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2010|01/11/2011|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE TIP ELECTRODE STEM OUTER DIAMETER (OD) SO THAT THE GAP BETWEEN THE TIP ELECTRODE OD AND TUBE INSIDE DIAMETER (ID) IS REDUCED TO -0.0015¿ TO +0.0015¿ FROM -0.003¿ TO +0.003¿ FOR CONSISTENT GAP INTERFERENCE.
P040042|S020|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 ABLATION CATHETER|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2010|01/11/2011|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE TIP ELECTRODE STEM OUTER DIAMETER (OD) SO THAT THE GAP BETWEEN THE TIP ELECTRODE OD AND TUBE INSIDE DIAMETER (ID) IS REDUCED TO -0.0015¿ TO +0.0015¿ FROM -0.003¿ TO +0.003¿ FOR CONSISTENT GAP INTERFERENCE.
P980035|S196|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|IMPLANTABLE PULSE GENERATOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2010|12/15/2010|||OK30|IMPLEMENTATION OF SPLATTER GUARD DURING CURRENT COLLECTOR WELD PROCESS.
P000053|S032|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2010|12/15/2010|||OK30|
P010020|S018|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2010|12/15/2010|||OK30|CHANGE TO THE CONTRACT MANUFACTURING SITE OF A COMPONENT.
P030017|S111|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2010|12/17/2010|||OK30|ADDITION OF AN ALTERNATE PRINTED CIRCUIT BOARD SUPPLIER (PCB).
P040002|S029|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/18/2010|01/20/2011|||APPR|APPROVAL FOR CONSOLIDATION OF ALL INNER CORE CONFIGURATIONS FOR THE 17FR INTUITRAK ACCESSORY DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME POWERLINK STENT GRAFT SYSTEM WITH INTUITRAK DELIVERY SYSTEM AND IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS.
P070022|S007|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2010|12/15/2010|||OK30|ADDITION OF IN- PROCESS INSPECTION TOOLS FOR THE ADIANA MATRIX.
P000053|S033|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/2010|12/16/2010|||APPR|APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE AMS 800 ARTIFICIAL URINARY SPHINCTER.
P010020|S019|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER|MIP|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/2010|12/16/2010|||APPR|APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER.
P010013|S032|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2010|02/18/2011|||APPR|APPROVAL FOR A MANUFACTURING PROCESS CHANGE TO THE MOLDED MANIFOLD COMPONENT TO REQUIRE THE COMPONENT TO BE ANNEALED.
P070022|S008|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2010|05/05/2011|||APPR|APPROVAL FOR REVISION OF WRIITEN WORK INSTRUCTIONS FOR A SOLDERING OPERATION.
P970003|S118|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEMS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2010|12/17/2010|||OK30|ADDITION OF AN ALTERNATIVE MANUFACTURING PROCESS MATERIAL AND SUPPLIER.
P970051|S065|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|COCHLEAR NUCLEUS 24 IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2010|12/15/2010|||OK30|ADDITION OF A NEW ETHYLENE OXIDE STERILIZER AND CHANGES IN STERILIZATION PARAMETERS.
P050016|S007|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/19/2010|01/13/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE CORMET HIP RESURFACING SYSTEM WHICH IS INDICATED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD AND CEMENTLESS ACETABULAR COMPONENT.  THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING CONDITIONS: 1) NON- INFLAMMATORY DEGENERATIVE ARTHRITIS SUCH AS OSTEOARTHRITIS AND AVASCULAR NECROSIS; AND 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.  THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING IPSILATERAL HIP JOINT REVISION.
P910007|S023|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA (LN 6C06)|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|06/08/2011|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTIC DIVISION IN SLIGO, IRELAND.
P950018|S014|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/21/2010|||OK30|ADDITION OF A CLEAN STEAM GENERATOR AND MINIMUM LOAD CONFIGURATION.
P050052|S028|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|EVALUATION OF THE IN-HOUSE MANUFACTURING SOURCE OF CALCIUM HYDROXYLAPATITE PARTICLES AS AN ADDITIONAL SUPPLIER FOR THIS COMPONENT OF RADIESSE.
P050037|S025|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|EVALUATION OF THE IN-HOUSE MANUFACTURING SOURCE OF CALCIUM HYDROXYLAPATITE PARTICLES AS AN ADDITIONAL SUPPLIER FOR THIS COMPONENT OF RADIESSE.
P030017|S112|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/22/2010|01/20/2011|||APPR|APPROVAL FOR A SUTURE SLEEVE CONFIGURATION WITH AN EMBEDDED SET SCREW FOR USE IN SECURING THE LEAD.
P950034|S038|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|INSTALLATION OF PROCESS EQUIPMENT.
P840001|S169|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 INS/SYNERGY FAMILY INS/EXTENSION KIT, RESTORE/POCKET ADAPTORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|UPDATE OF AN INSPECTION PROCEDURE AND ACCEPTANCE OF RECEIVING FACILITIES FOR THE INNER AND OUTER MOLDED SEALING RING COMPONENTS.
P960009|S101|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC/SOLETRA/KINETRA INS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|UPDATE OF AN INSPECTION PROCEDURE AND ACCEPTANCE OF RECEIVING FACILITIES FOR THE INNER AND OUTER MOLDED SEALING RING COMPONENTS.
P970004|S099|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM INS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|UPDATE OF AN INSPECTION PROCEDURE AND ACCEPTANCE OF RECEIVING FACILITIES FOR THE INNER AND OUTER MOLDED SEALING RING COMPONENTS.
P030011|S009|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/22/2010|01/04/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960042|S023|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH (SLSII)|MFA|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|11/18/2011|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT CARIDIANBCT STERILIZATION SERVICES IN LAKEWOOD, COLORADO.
P910001|S040|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS CORONARY ATHERECTOMY (ELCA) CATHETERS|LPC|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|11/18/2011|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT CARIDIANBCT STERILIZATION SERVICES IN LAKEWOOD, COLORADO.
P970003|S119|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/22/2010|01/21/2011|||APPR|APPROVAL FOR THE ASPIRE HC MODEL 105 GENERATOR.
P050051|S007|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|04/04/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P910023|S253|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICDS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|04/25/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE RF ANTENNA MODULE.
P030054|S176|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF CRT-DS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|04/25/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE RF ANTENNA MODULE.
P870077|S037|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.
P870056|S041|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE BIOPROSTHETIC VALVES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.
P860057|S073|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.
P010041|S025|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS PORCINE STENTLESS BIOPROSTHETIC VALVES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.
P000007|S026|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2010|12/22/2010|||OK30|USE OF ADDITIONAL STERILIZATION EQUIPMENT AND MINOR CHANGES TO STERILIZATION CYCLE.
P030054|S177|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF HAMILY OF CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2010|04/04/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 12.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030035|S075|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II FAMILY OF CRT-PS|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2010|04/04/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 12.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P890003|S208|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|IMPLANTABLE PULSE GENERATOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2010|12/22/2010|||OK30|MOVING MANUFACTURE OF MULTIPLE PRINTED CIRCUIT BOARD ASSEMBLIES TO A NEW MANUFACTURING LINE.
P880006|S070|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2010|04/04/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 12.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880086|S195|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2010|04/04/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 12.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P910023|S254|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2010|04/04/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 12.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P970013|S038|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2010|04/04/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 12.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P070022|S009|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2010|12/21/2010|||OK30|NEW MANUFACTURING LINE AND THE ADDITION OF MANUFACTURING EQUIPMENT.
P980003|S027|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/23/2010|01/21/2011|||APPR|APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE CHILLI TUBING KIT MODEL 2104.
P990040|S016|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYLCYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2010|12/22/2010|||OK30|IMPLEMENTATION OF A PARAMETRIC RELEASE PROCESS FOR ETHYLENE OXIDE STERILIZED PRODUCTS.
P890055|S027|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 IMPLANTABLE DRUG DELIVERY SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2010|12/22/2010|||OK30|IMPLEMENTATION OF A PARAMETRIC RELEASE PROCESS FOR ETHYLENE OXIDE STERILIZED PRODUCTS.
P800036|S037|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|IMPLANTABLE DRUG DELIVERY SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2010|12/22/2010|||OK30|IMPLEMENTATION OF A PARAMETRIC RELEASE PROCESS FOR ETHYLENE OXIDE STERILIZED PRODUCTS.
P860057|S074|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2010|12/23/2010|||OK30|CHANGE TO THE CLEANROOM.
P040050|S007|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2010|02/04/2011|||APPR|APPROVAL FOR A CONTRACT GAMMA STERILIZATION SITE LOCATED AT STERIS/ISOMEDIX CONTRACT STERILIZATION SERVICES, LIBERTYVILLE, ILLINOIS.
P840001|S170|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 INS/SYNERGY FAMILY INS/EXTENSION KIT, RESTORE/POCKET ADAPTORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2010|12/23/2010|||OK30|USE OF A NEW MOLD FOR AN INNER SEALING RING COMPONENT AND THE ADDITION OF A SECOND SUPPLIER FOR THE COMPONENT.
P970004|S100|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM INS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2010|12/23/2010|||OK30|USE OF A NEW MOLD FOR AN INNER SEALING RING COMPONENT AND THE ADDITION OF A SECOND SUPPLIER FOR THE COMPONENT.
P960009|S102|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC INS/SOLETRA INS/KINETRA INS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2010|12/23/2010|||OK30|USE OF A NEW MOLD FOR AN INNER SEALING RING COMPONENT AND THE ADDITION OF A SECOND SUPPLIER FOR THE COMPONENT.
P820003|S103|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2010|12/20/2010|||OK30|ADDITIONAL ACCELERATED TEST EQUIPMENT.
P090006|S003|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2010|01/14/2011|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED IN OFFALY, IRELAND.
P010012|S260|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY SPIRAL LEAD FAMILY|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2010|08/05/2011|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:  1) ADD AN ALTERNATE DEXAMETHASONE ACETATE SUPPLIER; 2) UPDATE TO DXA MIXING PROCESS PARAMETERS TO ENHANCE PROCESS CAPABILITY; 3) ALTERNATE ANALYTICAL METHOD TO TEST FOR DOSAGE AND PRODUCT DEGRADATION; 4) MODIFICATION OF THE ANALYTICAL METHODS TO REMOVE IMPURITY PEAKS OBSERVED; AND 5) ADD IN PROCESS VERIFICATION FOR MIX HOMOGENEITY.
P840001|S171|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2010|12/23/2010|||OK30|CHANGES TO THE ELECTRICAL TEST SOFTWARE.
P960009|S103|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2010|12/23/2010|||OK30|CHANGES TO THE ELECTRICAL TEST SOFTWARE.
P070015|S054|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/26/2010|05/24/2011|11M-0431|06/03/2011|APPR|APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 2.25 MM XIENCE V EVEROLIMUS ELUTING CORONARY STEM SYSTEM. THIS DEVICE SIZE WILL BE MARKETED UNDER THE TRADE NAME XIENCE  NANO EVEROLIMUS ELUTING CORONARY STEM SYSTEM AND WILL ALSO BE DISTRIBUTED AS THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM.  THE ADDITION OF THE 2.25 MM XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM WILL EXPAND THE ORIGINALLY APPROVED INDICATIONS TO INCLUDE TREATMENT OF CORONARY ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS >2.25 MM TO <2.50 MM. THEREFORE, THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER INPATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH < 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.25 MM.
P040002|S030|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2010|12/29/2010|||OK30|USE OF SILICONE LUBRICANT AS A MANUFACTURING AID FOR THE POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM.
P010020|S020|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER|MIP|GU|30-Day Notice||N|11/26/2010|12/22/2010|||OK30|CHANGE TO THE CONTRACT MANUFACTURING SITE OF A COMPONENT.
P000053|S034|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2010|12/22/2010|||OK30|CHANGE TO THE CONTRACT MANUFACTURING SITE OF A COMPONENT.
P060019|S016|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE BLU AND THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2010|12/23/2010|||OK30|ADDITION OF TWO SUPPLIERS, THE REPLICATION OF THE SUBASSEMBLY PROCESS, AND A MINOR MANUFACTURING CHANGE.
P970004|S101|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2010|12/29/2010|||OK30|A SUPPLIER MANUFACTURING FIXTURE CHANGE.
P980049|S061|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|MRM|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/29/2010|12/21/2012|||APPR|APPROVAL FOR UPDATING THE LABELING OF THE DEVICES BASED ON THE POST-APPROVAL STUDY RESULTS.
P980006|S016|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2010|12/27/2010|||OK30|UPGRADE TO A PORTION OF THE MANUFACTURING PROCESS OF THE AUTOMATED AUTONOMOUS EXTENSIBLE GLOBAL INSPECTION SYSTEM (AEGIS) AND FREEDIAL WET VISION AUTOMATED INSPECTION SYSTEM (AIS).
P980006|S017|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS|LPM|OP|30-Day Notice||N|12/01/2010|12/27/2010|||OK30|REDUCTION OF THE SAMPLE SIZE TESTING PHYSICAL PROPERTIES ACCEPTANCE CRITERIA DURING THE USE OF THE AUTOMATED INSPECTION SYSTEM FOR THE PUREVISION (BALAFILCON A) CONTACT LENSES.  THIS CHANGE OF THE SAMPLING PLAN APPLIES ONLY TO BAUSCH & LOMB¿S WATERFORD, IRELAND FACILITY.
P960006|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|TRANSVENOUS BIPOLAR PACING LEAD|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2010|05/19/2011|||APPR|APPROVAL FOR A CHANGE TO LASER WELDING EQUIPMENT USED IN THE MANUFACTURE OF PACING LEADS.
P910001|S041|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2010|12/29/2010|||OK30|CHANGE IN PROCESSING EQUIPMENT FROM HAND-ACTIVATED TO FOOT-ACTIVATED.
P040024|S051|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/2010|10/11/2011|11M-0735|10/20/2011|APPR|APPROVAL FOR RESTYLANE INJECTABLE GEL.  THIS DEVICE IS INDICATED FOR: 1)  MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS; AND 2) SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION IN PATIENTS OVER THE AGE OF 21.
P810002|S072|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2010|02/07/2011|||OK30|CHANGE IN GEL FIXATION TIME.
P070015|S055|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2010|12/30/2010|||OK30|POOLING OF STENT BATCHES MANUFACTURED USING DIFFERENT SUITES WITHIN THE SAME MANUFACTURING SITE USING APPROVED PROCEDURES.
P050018|S012|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2010|03/30/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN SALT LAKE CITY, UTAH.
P000006|S022|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/02/2010|01/24/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE RESERVOIR COMPONENT (I.E., THE CLOVERLEAF (CL) RESERVOIR) AND ASSOCIATED LABELING CHANGES.
P050020|S032|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FRESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/02/2010|05/16/2011|||APPR|APPROVAL FOR CHANGES TO THE QUALITY SYSTEM DRAWINGS OF TEN RECEIVER AND TRANSMITTER COMPONENTS, USED FOR FIRST ARTICLE INSPECTION ACTIVITIES PRIOR TO RELEASE FOR MANUFACTURING.
P910023|S255|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2010|12/23/2010|||OK30|ALTERNATE SUPPLIER FOR AN ORGANIC SUBSTRATE THAT WILL BE USED IN ELECTRICAL COMPONENTS.
P030054|S178|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2010|12/23/2010|||OK30|ALTERNATE SUPPLIER FOR AN ORGANIC SUBSTRATE THAT WILL BE USED IN ELECTRICAL COMPONENTS.
P980006|S018|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION (BALAFILCON A) CONTACT LENS|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|12/03/2010|06/03/2014|||APPR|APPROVAL FOR THE REVISION OF THE LABELING FOR THE PUREVISION® (BALAFILCON A)CONTACT LENS TO INCLUDE THE RESULTS OF THE POST-APPROVAL STUDY.
P070027|S026|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2010|01/05/2011|||OK30|ADDITION OF AN ALTERNATE STENT CRIMPING MACHINE.
P070007|S025|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2010|01/05/2011|||OK30|ADDITION OF AN ALTERNATE STENT CRIMPING MACHINE.
P960043|S072|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE AT 6F & PROGLIDE SUTURE-MEDICATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2010|01/05/2011|||OK30|ADDITIONAL MANUFACTURING EQUIPMENT AT THE SHEATH COATING STATION.
P030024|S014|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2010|02/28/2011|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING SCALE FOR A COMPONENT REAGENT.
P030050|S009|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AND SCULPTRA AESTHETIC|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|12/06/2010|12/09/2011|||APPR|APPROVAL FOR: 1) A REVISION OF SCULPTRA AND SCULPTRA AESTHETIC LABELING TO INCLUDE INFORMATION CONCERNING A PRECLINICAL IMAGING STUDY COMPLETED AS CONDITION OF APPROVAL; AND 2) TO REVISE THE STORAGE CONDITIONS PRESENTED IN YOUR PRODUCT LABEL.
P970027|S012|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2010|01/05/2011|||OK30|ADDITION OF AN ALTERNATIVE SOURCE OF DEXTRAN SULFATE FOR THE MANUFACTURE OF AXSYM ANTI-HCV SPECIMEN DILUENT 2.
P980016|S267|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2010|12/23/2010|||OK30|UPGRADE TO THE RADIO FREQUENCY MODULE TEST SYSTEM.
P010031|S221|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2010|12/23/2010|||OK30|UPGRADE TO THE RADIO FREQUENCY MODULE TEST SYSTEM.
P010031|S222|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CONCERTO II, CONSULTA AND MAXIMO II|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/07/2010|03/22/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES TO THE MULTILAYER CERAMIC CAPACITORS (XC308, XC251, XC259, AND XC263) FOR CONCERTO II MODEL D274TRK; CONSULTA MODEL D224TRK; AND MAXIMO II MODELD284TRK; MAXIMO II MODELS D284DRG, D2S4VRC; SECURA MODELS D224DRG, D224VRC; ANDVIRTUOSO MODELS D274DRG. D274VRG; ENRHYTHM MODEL P1501DR; VITATRON DA+ C- SERIES MODELS C20A1, C20A3, C60A1, C60A3; AND VITATRON DA+ T-SERIES MODELS T2OA1, T6OA1;
P840001|S172|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY/ITREL3 FAMILY/SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS/SPECIFY SURGICAL LEADS/HINGED 2X4 SURGICAL|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2010|01/05/2011|||OK30|UPGRADE OF SOFTWARE USED FOR STATISTICAL PROCESS CONTROL AND ANALYSIS OF INSPECTION DATA.
P980016|S268|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II, SECURA AND VIRTUOSO II|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/07/2010|03/22/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES TO THE MULTILAYER CERAMIC CAPACITORS (XC308, XC251, XC259, AND XC263) FOR CONCERTO II MODEL D274TRK; CONSULTA MODEL D224TRK; AND MAXIMO II MODELD284TRK; MAXIMO II MODELS D284DRG, D2S4VRC; SECURA MODELS D224DRG, D224VRC; ANDVIRTUOSO MODELS D274DRG. D274VRG; ENRHYTHM MODEL P1501DR; VITATRON DA+ C- SERIES MODELS C20A1, C20A3, C60A1, C60A3; AND VITATRON DA+ T-SERIES MODELS T2OA1, T6OA1;
P980035|S197|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/07/2010|03/22/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES TO THE MULTILAYER CERAMIC CAPACITORS (XC308, XC251, XC259, AND XC263) FOR CONCERTO II MODEL D274TRK; CONSULTA MODEL D224TRK; AND MAXIMO II MODELD284TRK; MAXIMO II MODELS D284DRG, D2S4VRC; SECURA MODELS D224DRG, D224VRC; ANDVIRTUOSO MODELS D274DRG. D274VRG; ENRHYTHM MODEL P1501DR; VITATRON DA+ C- SERIES MODELS C20A1, C20A3, C60A1, C60A3; AND VITATRON DA+ T-SERIES MODELS T2OA1, T6OA1;
P860004|S144|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMPS/INTRA-ARTERIAL VASCULAR CATHETERS/VASCULAR CATHETERS/INDURA 1P INTRATHECAL|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2010|01/05/2011|||OK30|UPGRADE OF SOFTWARE USED FOR STATISTICAL PROCESS CONTROL AND ANALYSIS OF INSPECTION DATA.
P990001|S080|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/07/2010|03/22/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES TO THE MULTILAYER CERAMIC CAPACITORS (XC308, XC251, XC259, AND XC263) FOR CONCERTO II MODEL D274TRK; CONSULTA MODEL D224TRK; AND MAXIMO II MODELD284TRK; MAXIMO II MODELS D284DRG, D2S4VRC; SECURA MODELS D224DRG, D224VRC; ANDVIRTUOSO MODELS D274DRG. D274VRG; ENRHYTHM MODEL P1501DR; VITATRON DA+ C- SERIES MODELS C20A1, C20A3, C60A1, C60A3; AND VITATRON DA+ T-SERIES MODELS T2OA1, T6OA1;
P960009|S104|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY/SOLETRA/KINETRA IMPLANTABLE NEUROSTIMULATORS/LEADS/STEREOTACTIC FRAME LEAD KIT/EXTENSIONS/ADAPTORS/MAGNET|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2010|01/05/2011|||OK30|UPGRADE OF SOFTWARE USED FOR STATISTICAL PROCESS CONTROL AND ANALYSIS OF INSPECTION DATA.
P970004|S102|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/MAGNET|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2010|01/05/2011|||OK30|UPGRADE OF SOFTWARE USED FOR STATISTICAL PROCESS CONTROL AND ANALYSIS OF INSPECTION DATA.
P990034|S021|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SIDE CATHETER ACCESS PORTS KITS/BULK/REFILLS KITS/BULKS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2010|01/05/2011|||OK30|UPGRADE OF SOFTWARE USED FOR STATISTICAL PROCESS CONTROL AND ANALYSIS OF INSPECTION DATA.
P050012|S035|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|09/02/2011|||APPR|APPROVAL FOR A PROPOSED CHANGE TO REPLACE THE PASTE IN THE SURFACE MOUNT TECHNOLOGY (SMT) COMPONENT SOLDERING PROCESS FOR THE TRANSMITTER COMPONENT OF THE DEVICE.
P980035|S198|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|AT500 SYSTEM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|01/06/2011|||OK30|CHANGE IN THE CONTROL OF THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM.
P010015|S105|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|01/06/2011|||OK30|CHANGE IN THE CONTROL OF THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM.
P010031|S223|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC MARQUIS ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|01/06/2011|||OK30|CHANGE IN THE CONTROL OF THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM.
P840001|S173|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3/SOLETRA/SYNERGY/SYNERGY VERSITREL/OCTAPOLAR EXTENSION KIT (IN-LINE CONNECTOR) FOR NEUROSTIMULATION|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|01/07/2011|||OK30|UPGRADE OF SOFTWARE USED FOR MANAGING QUALITY CHECKS AND REPORTING OF INCOMING MATERIALS.
P860004|S145|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|01/07/2011|||OK30|UPGRADE OF SOFTWARE USED FOR MANAGING QUALITY CHECKS AND REPORTING OF INCOMING MATERIALS.
P960009|S105|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|LEAD KIT FOR DEEP BRAIN STIMULATION/QUADRIPOLAR EXTENSION KIT FOR DEEP BRAIN STIMULATION|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|01/07/2011|||OK30|UPGRADE OF SOFTWARE USED FOR MANAGING QUALITY CHECKS AND REPORTING OF INCOMING MATERIALS.
P970004|S103|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/INTERSTIM II/INTERSTIM LEAD KIT PERCUTANEOUS NON-TINED/INTERSTIM TINED LEAD KIT|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|01/07/2011|||OK30|UPGRADE OF SOFTWARE USED FOR MANAGING QUALITY CHECKS AND REPORTING OF INCOMING MATERIALS.
P950032|S061|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2010|01/07/2011|||APPR|APPROVAL FOR THE ADDITION OF FINISHED PRODUCT ENDOTOXIN RELEASE TESTING FOR APLIGRAF.
P030054|S179|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MERLIN 3650 PROGRAMMER|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2010|01/07/2011|||OK30|ALTERNATE SUPPLIER FOR THE PRINTED CIRCUIT BOARD (PCB) USED IN THE MERLIN 3650 PROGRAMMER.
P980035|S199|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2010|01/07/2011|||OK30|RELOCATION OF A STERILIZER SYSTEM WITHIN AN EXISTING LOCATION.
P950037|S091|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA / ENTOVIS FAMILY OF PULSE GENERATORS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/10/2010|03/25/2011|||APPR|APPROVAL FOR UPDATED INTEGRATED CIRCUITS FOR USE IN THE CURRENTLY MARKETED EVIA/ ENTOVIS/ESTELLA/ ECURO/EFFECTA FAMILY OF PULSE GENERATORS.
P970012|S080|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|01/07/2011|||OK30|RELOCATION OF A STERILIZER SYSTEM WITHIN AN EXISTING LOCATION.
P980016|S269|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/SECURA DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2010|01/07/2011|||OK30|RELOCATION OF A STERILIZER SYSTEM WITHIN AN EXISTING LOCATION.
P010031|S224|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2010|01/07/2011|||OK30|RELOCATION OF A STERILIZER SYSTEM WITHIN AN EXISTING LOCATION.
P010015|S106|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P/INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2010|01/07/2011|||OK30|RELOCATION OF A STERILIZER SYSTEM WITHIN AN EXISTING LOCATION.
P990001|S081|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2010|01/07/2011|||OK30|RELOCATION OF A STERILIZER SYSTEM WITHIN AN EXISTING LOCATION.
P060033|S061|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|04/12/2011|||APPR|APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.
P030009|S051|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER/MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|04/12/2011|||APPR|APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.
P070007|S026|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|04/12/2011|||APPR|APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.
P070027|S027|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|04/12/2011|||APPR|APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.
P990020|S043|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|04/12/2011|||APPR|APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.
P030009|S052|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|01/06/2011|||OK30|REMOVAL OF SPECIFIED AUDIT OC INSPECTION STEPS.
P060033|S062|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|01/06/2011|||OK30|REMOVAL OF SPECIFIED AUDIT OC INSPECTION STEPS.
P950034|S039|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM|MCN|SU|30-Day Notice||N|12/10/2010|01/20/2011|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER OF RAW MATERIAL EDC.
P920015|S072|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2010|01/07/2011|||OK30|CHANGE TO THE ORIENTATION OF THE HELIX TO DRIVESHAFT LUG COMPONENT AND CHANGES TO THE INSPECTIONS FOR DRIVESHAFT LUG POSITION.
P960013|S063|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL LEADS|NVN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2010|02/03/2011|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE SUPPLIER FOR THE MANUFACTURE OF SHAFT ASSEMBLIES.
P070014|S020|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/13/2010|03/17/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040013|S016|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENHANCED MATRIX|NPZ|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2010|05/27/2011|||APPR|APPROVAL FOR A CHANGE IN THE RH-PDGF-BB SYRINGE CAP MATERIAL, MADE BY BECTON DICKINSON, THE CAP SUPPLIER, FROM WEST 1883 TO HELOVET FM27, BASED ON A CHANGE IN BECTON DICKINSON RUBBER RAW MATERIALS SUPPLIERS.
P840001|S174|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2010|01/12/2011|||OK30|CHANGES TO THE BATTERY TESTING CRITERIA.
P830037|S051|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|DURASOFT 3 (PHEMFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2010|01/11/2011|||OK30|ALTERNATE SUPPLIER FOR METHACRYLIC ACID (MAA).
P030017|S113|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2010|01/12/2011|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT USED IN THE ASSEMBLY OF SPINAL CORD STIMULATOR CHARGERS.
P010013|S033|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2010|01/07/2011|||OK30|ANNEALING AND MOLD MODIFICATIONS IN THE MANUFACTURE OF THE FRONT GRIP COMPONENT.
P950037|S092|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ESTELLA AND EFFECTA PULSE GENERATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2010|02/11/2011|||APPR|APPROVAL FOR THE ICS 3000 PROGRAMMER APPLICATION SOFTWARE VERSION PSW 1004.U, AND THE ESTELLA DR; ESTELLA DR-T; ESTELLA SR; ESTELLA SR-T; ECURO DR; ECURO DR-T; ECURO SR; ECURO SR-T; EFFECTA D; EFFECTA DR; EFFECTA S; AND EFFECTA SR.  THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES LISTED ABOVE, AND IS INDICATED FOR THE APPROVED INDICATION FOR USE.
P000009|S043|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2010|02/11/2011|||APPR|APPROVAL FOR THE ICS 3000 PROGRAMMER APPLICATION SOFTWARE VERSION PSW 1004.U, AND THE ESTELLA DR; ESTELLA DR-T; ESTELLA SR; ESTELLA SR-T; ECURO DR; ECURO DR-T; ECURO SR; ECURO SR-T; EFFECTA D; EFFECTA DR; EFFECTA S; AND EFFECTA SR.  THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES LISTED ABOVE, AND IS INDICATED FOR THE APPROVED INDICATION FOR USE.
P050023|S041|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2010|02/11/2011|||APPR|APPROVAL FOR THE ICS 3000 PROGRAMMER APPLICATION SOFTWARE VERSION PSW 1004.U, AND THE ESTELLA DR; ESTELLA DR-T; ESTELLA SR; ESTELLA SR-T; ECURO DR; ECURO DR-T; ECURO SR; ECURO SR-T; EFFECTA D; EFFECTA DR; EFFECTA S; AND EFFECTA SR.  THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES LISTED ABOVE, AND IS INDICATED FOR THE APPROVED INDICATION FOR USE.
P070008|S021|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2010|02/11/2011|||APPR|APPROVAL FOR THE ICS 3000 PROGRAMMER APPLICATION SOFTWARE VERSION PSW 1004.U, AND THE ESTELLA DR; ESTELLA DR-T; ESTELLA SR; ESTELLA SR-T; ECURO DR; ECURO DR-T; ECURO SR; ECURO SR-T; EFFECTA D; EFFECTA DR; EFFECTA S; AND EFFECTA SR.  THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES LISTED ABOVE, AND IS INDICATED FOR THE APPROVED INDICATION FOR USE.
P020009|S068|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/13/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P040016|S065|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/13/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P060008|S062|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/13/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P060006|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/13/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P090003|S008|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/13/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P980022|S091|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/12/2011|||OK30|MINOR MANUFACTURING CHANGES TO THE SOF-SENSOR GLUCOSE SENSOR MMT-7002.  THE CHANGES DO NOT INVOLVE ANY CHANGES TO THE DEVICE DESIGN OR PERFORMANCE SPECIFICATIONS.
P910073|S091|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|ENDOTAK RELIANCE IS-I PASSIVE FIXATION|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2010|01/05/2012|||APPR|APPROVAL FOR DRUG MATERIAL AND SUPPLIER CHANGES AS WELL AS DISTAL TIP DESIGN CHANGES.
P010031|S225|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA /MAXIMO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/13/2011|||OK30|ACCEPTANCE OF AN UPGRADE OF THE D363 INTEGRATED CIRCUIT FOR CONTINUOUS TEST COVERAGE AND TEST METHODOLOGY.
P980016|S270|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DRVR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/13/2011|||OK30|ACCEPTANCE OF AN UPGRADE OF THE D363 INTEGRATED CIRCUIT FOR CONTINUOUS TEST COVERAGE AND TEST METHODOLOGY.
P990013|S030|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2010|01/13/2011|||OK30|PARAMETRIC RELEASE OF SINGLE PIECE COLLAMER INTRAOCULAR LENSES.
P820033|S007|Asahi Kasei Medical Co., Ltd.|1-105 KANDA JINBOCHO|CHIYODA-KU|TOKYO||101-8|8101|Separator for therapeutic purposes, membrane automated blood cell/plasma|PLASMAFLO OP-05W (A)|MDP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2010|01/28/2011|||OK30|A NEW POLYMER SUPPLIER.
P090022|S004|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2010|02/02/2011|||APPR|APPROVAL TO EXTEND THE POWER RANGE FOR WHICH LENSES ARE MARKETED IN 1/4 DIOPTER INCREMENT FROM 18.0 THROUGH 25.0 DIOPTERS TO 15.0 THROUGH 25.0 DIOPTERS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD PS POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21.  THE LENS IS INDICATED FOR CAPSULAR BAG PLACEMENT.
P050034|S004|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE|NCJ|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/15/2010|02/04/2011|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE OF THE IMT FROM 2 YEARS TO 3 YEARS.
P980022|S092|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2010|01/31/2011|||APPR|APPROVAL FOR A SOFTWARE CHANGE TO THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES, MMT-7333, FROM VERSION 5.3A TO 5.4A.
P980049|S062|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2010|02/10/2011|||APPR|APPROVAL FOR THE CHANGES OF THE TRANSFORMER (T413), OPTO WEDGE (G309), AND DESICCANT (J907) FOR THE PARADYM ICD AND CRT-D MODELS 8250, 8550, AND 8750.
P060027|S029|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM ICDS AND CRT-D DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2010|02/10/2011|||APPR|APPROVAL FOR THE CHANGES OF THE TRANSFORMER (T413), OPTO WEDGE (G309), AND DESICCANT (J907) FOR THE PARADYM ICD AND CRT-D MODELS 8250, 8550, AND 8750.
P040002|S031|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2010|05/06/2011|||APPR|APPROVAL FOR A NEW EPTFE GRAFT PROCESS AS WELL AS CHANGES TO THE DELIVERY SYSTEM.
P880086|S196|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT PACERS AND ANTHEM RF CRT-P DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2010|01/14/2011|||OK30|USE OF ALTERNATE UV CURE ADHESIVE FROM AN ALTERNATE SUPPLIER.
P030035|S076|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ACCENT PACERS AND ANTHEM RF CRT-P DEVICES|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2010|01/14/2011|||OK30|USE OF ALTERNATE UV CURE ADHESIVE FROM AN ALTERNATE SUPPLIER.
P010012|S261|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD & EASYTRAK CRT-D SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2010|01/14/2011|||OK30|ADDITION OF A LASER CLEAVE CUT REWORK PROCESS FOR THE PULSE GENERATOR CAPACITOR STACK MANUFACTURING PROCESS.
P960040|S239|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VENTAK PRIZM DR/VR/VITALITY ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2010|01/14/2011|||OK30|ADDITION OF A LASER CLEAVE CUT REWORK PROCESS FOR THE PULSE GENERATOR CAPACITOR STACK MANUFACTURING PROCESS.
P910073|S092|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE 4-SITE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2010|02/11/2011|||APPR|APPROVAL FOR A DECREASE IN THE LENGTH OF THE POLYURETHANE TUBING PRESENT AT THE PROXIMAL END OF THE LEAD AND A LABELING NOTE REGARDING IMPLANTATION TECHNIQUE.
P020009|S069|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 MONORAIL & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2010|01/14/2011|||OK30|SOFTWARE UPGRADE TO PROCESS EQUIPMENT.
P040016|S066|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2010|01/14/2011|||OK30|SOFTWARE UPGRADE TO PROCESS EQUIPMENT.
P060008|S063|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE MONORAIL & OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2010|01/14/2011|||OK30|SOFTWARE UPGRADE TO PROCESS EQUIPMENT.
P030009|S053|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|REMOVAL OF REDUNDANT PACKAGING INSPECTIONS.
P090006|S004|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|REMOVAL OF REDUNDANT PACKAGING INSPECTIONS.
P010031|S226|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|MODIFICATION OF TEST SOFTWARE USED FOR FINAL ACCEPTANCE OF IMPLANTABLE DEVICES.
P980016|S271|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II/SECURA/MAXIMO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|MODIFICATION OF TEST SOFTWARE USED FOR FINAL ACCEPTANCE OF IMPLANTABLE DEVICES.
P010031|S227|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|CHANGES TO THE DEVICE RF TEST REQUIREMENTS USED DURING FINAL FUNCTIONAL DEVICE TESTING.
P980016|S272|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II/SECURA/MAXIMO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|CHANGES TO THE DEVICE RF TEST REQUIREMENTS USED DURING FINAL FUNCTIONAL DEVICE TESTING.
P020009|S070|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|CHANGE TO THE CATHETER INSPECTION PROCESS.
P030025|S092|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS EXPRESS ATOM STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|CHANGE TO THE CATHETER INSPECTION PROCESS.
P040016|S067|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|CHANGE TO THE CATHETER INSPECTION PROCESS.
P060008|S064|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|CHANGE TO THE CATHETER INSPECTION PROCESS.
P960040|S240|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM HE/3/VITALITY/2/AVT/CONFIENT/TELIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|AUTOMATION OF INSPECTIONS FOR THE PULSE GENERATORS.
P030005|S072|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|AUTOMATION OF INSPECTIONS FOR THE PULSE GENERATORS.
P010012|S262|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3/LIVIAN/COGNIS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2010|01/19/2011|||OK30|AUTOMATION OF INSPECTIONS FOR THE PULSE GENERATORS.
P080006|S019|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2010|01/20/2011|||OK30|MOVE TO A 50 RPM PADDLE SPEED FOR THE TIP AND RING ELUTION METHOD.
P010023|S008|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2010|03/02/2011|||OK30|CHANGE TO THE IPC SHELL FABRICATION PROCESS.
P030017|S114|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2010|01/20/2011|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER.
P030017|S115|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2010|01/20/2011|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE ELECTRODES AND CONTACTS USED IN THE ASSEMBLY OF SCS LEADS.
P840001|S175|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION SYSTEMS|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/21/2010|01/20/2011|||APPR|APPROVAL TO ADD NEW PRECAUTIONS REQUIRED FOR COMPLIANCE WITH APPLICABLE PORTIONS OF THE ¿IEC 60601-1 STANDARD FOR MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE.¿
P960009|S106|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/21/2010|01/20/2011|||APPR|APPROVAL TO ADD NEW PRECAUTIONS REQUIRED FOR COMPLIANCE WITH APPLICABLE PORTIONS OF THE ¿IEC 60601-1 STANDARD FOR MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE.¿
P860057|S075|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2010|01/20/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P870056|S042|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS PROCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2010|01/20/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P010041|S026|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2010|01/20/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P870077|S038|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2010|01/20/2011|||OK30|CHANGE IN THE ENVIRONMENTAL QUALITY CONTROL PROCEDURE.
P980007|S015|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/13/2011|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
P910007|S024|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/13/2011|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
P980024|S004|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/10/2011|||OK30|PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION TO INCREASE THE BATCH RANGE UP TO 2000 ML.
P060007|S006|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/14/2011|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
P050051|S008|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/14/2011|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
P080023|S004|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/14/2011|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
P060035|S004|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/14/2011|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
P050042|S008|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/14/2011|||APPR|APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
P020009|S071|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/20/2011|||OK30|CHANGE TO THE PORT WELDING PROCESS.
P040016|S068|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/20/2011|||OK30|CHANGE TO THE PORT WELDING PROCESS.
P060008|S065|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|01/20/2011|||OK30|CHANGE TO THE PORT WELDING PROCESS.
P020009|S072|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|09/23/2011|||APPR|APPROVAL TO UPDATE THE GEL RATING SPECIFICATION SCALE USED FOR RESIN MATERIAL ACCEPTANCE.
P040016|S069|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|09/23/2011|||APPR|APPROVAL TO UPDATE THE GEL RATING SPECIFICATION SCALE USED FOR RESIN MATERIAL ACCEPTANCE.
P060008|S066|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|09/23/2011|||APPR|APPROVAL TO UPDATE THE GEL RATING SPECIFICATION SCALE USED FOR RESIN MATERIAL ACCEPTANCE.
P060006|S019|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|09/23/2011|||APPR|APPROVAL TO UPDATE THE GEL RATING SPECIFICATION SCALE USED FOR RESIN MATERIAL ACCEPTANCE.
P950020|S042|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|FLEXTOME CUTTING BALLOON|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2010|09/23/2011|||APPR|APPROVAL TO UPDATE THE GEL RATING SPECIFICATION SCALE USED FOR RESIN MATERIAL ACCEPTANCE.
P890003|S209|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK HOME MONITOR AND CARDIOSIGHT MONITOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2010|05/04/2011|||APPR|APPROVAL FOR UPDATES TO MEDTRONIC¿S REVEAL 2090 APPLICATION SOFTWARE MODEL SW007 FOR USE WITH THE MEDTRONIC REVEAL IMPLANTABLE CARDIAC MONITOR (ICM) SYSTEM.
P030006|S024|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILITATION SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/23/2010|05/13/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040034|S019|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/23/2010|01/20/2011|||APPR|APPROVAL FOR A MODIFICATION TO YOUR INSTRUCTIONS FOR USE TO INSTRUCT THE SURGEON IN THE BEST PRACTICES IN APPLYING THE SEALANT.
P050023|S043|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX ICDS/CRT-DS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2010|01/20/2011|||OK30|REMOVAL OF THE 72 HOUR STORAGE CONDITION DURING THE HEADER ATTACHMENT PROCESS.
P060038|S008|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2010|01/20/2011|||OK30|EXPANSION OF THE TISSUE APPLICATION CONTROLLED ENVIRONMENT.
P980053|S013|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2010|01/20/2011|||OK30|ADDITION OF A NEW CONTROLLED ENVIRONMENT AREA.
P830055|S117|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2010|01/10/2011|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP TO THE MANUFACTURING PROCESS OF THE SIGMA PS FEMORAL COMPONENTS AND THE SIGMA PS FEMORAL COMPONENTS WITH LUGS
P840001|S176|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT|LGW|NE|30-Day Notice||N|12/27/2010|01/26/2011|||OK30|CHANGES TO THE MANUFACTURING OF A COMPONENT FLEX CIRCUIT.
P890003|S210|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2010|03/17/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE CARELINK HOME MONITOR MODEL 2490G, DEVICE AND DATA MANAGEMENT APPLICATION MODEL 2491, AND CARDIOSIGHT READER MODEL 2020A.
P000025|S050|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/27/2010|07/22/2011|||APPR|APPROVAL FOR AN UPDATED VERSION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANTSYSTEM REFERRED TO AS MAESTRO 2010 CONSISTING OF THE FOLLOWING FEATURES:  1) A THINNER VERSION OF THE SONATATI- 100 COCHLEAR  IMPLANT, THE MI1000 MED-EL CONCERT;2) SEVERAL DESIGN AND MANUFACTURING UPDATES RELATED TO THE INTRODUCTION OF THE MI1000 MEDEL CONCERT; 3) NEW TASKS AND FUNCTIONALITIES ADDED TO THE MAESTRO FITTING SOFTWARE IN MAESTRO 4.0; 4) A SELECTION OF NEW COLORS AVAILABLE FOR THE OPUS 2 AUDIO PROCESSOR AND; 5) A NEW, MORE ENERGY-EFFICIENT, AUDIO PROCESSOR COIL CALLED D-COIL.
P870072|S046|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VAD SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2010|12/21/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT THORATEC CORPORATION IN SAN RAMON, CALIFORNIA FOR RECEIVING ACCEPTANCE ACTIVITIES, RECEIVING INSPECTION, WAREHOUSING, AND SHIPPING OPERATIONS.
P060040|S014|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LVAS|DSQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2010|12/21/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT THORATEC CORPORATION IN SAN RAMON, CALIFORNIA FOR RECEIVING ACCEPTANCE ACTIVITIES, RECEIVING INSPECTION, WAREHOUSING, AND SHIPPING OPERATIONS.
P920014|S031|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE XVE LVAS|DSQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2010|12/21/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT THORATEC CORPORATION IN SAN RAMON, CALIFORNIA FOR RECEIVING ACCEPTANCE ACTIVITIES, RECEIVING INSPECTION, WAREHOUSING, AND SHIPPING OPERATIONS.
P960009|S107|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|EXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT|MHY|NE|30-Day Notice||N|12/27/2010|01/26/2011|||OK30|CHANGES TO THE MANUFACTURING OF A COMPONENT FLEX CIRCUIT.
P080023|S005|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2010|05/20/2011|||APPR|APPROVAL FOR CHANGES TO MANUFACTURING METHODS AND PROCESS CHANGES.
P020014|S032|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|12/28/2010|02/24/2011|||APPR|APPROVAL FOR DESIGN CHANGES TO THE DUCKBILL VALVE OF THE VALVED INTRODUCER AND CHANGES TO THE LENGTH OF THE DELIVERY WIRE.
P040033|S018|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2010|09/11/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN WARWICK, UNITED KINGDOM.
P010032|S037|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON WALL CHARGER KIT|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/29/2010|02/24/2011|||APPR|APPROVAL FOR ANTENNA SPACER DISKS, WHICH ARE NEW ACCESSORIES FOR THE ALREADY APPROVED MODEL 3701 EON WALL CHARGER KIT.
P910071|S013|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL|LWL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/29/2010|01/24/2012|||APPR|APPROVAL FOR THE ADDITION OF A HEAT SHRINK TUBE TO THE PRIMARY PACKAGING FOR THE DEVICE TO ASSURE A TIGHTER FIT BETWEEN THE LUER ADAPTER AND THE SYRINGE BARREL BODY.
P980023|S043|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/29/2010|02/28/2011|||APPR|APPROVAL FOR: 1) ADDITION OF SILGLIDE SURFACE TREATMENT OF THE SILICONE LEAD BODY; 2) INCREASE IN OUTER DIAMETER OF LEAD BODY AT DF-1 CONNECTOR EXIT; AND 3) ADDITIONAL SUPPLIERS FOR SILICONE AND CONDUCTOR MATERIALS.
P080014|S006|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2010|01/20/2011|||OK30|ADDITION OF AN ALTERNATIVE VENDOR FOR CERVISTA® HPV OLIGOS MIX 1, MIX 2, MIX 3 USED IN THE CERVISTA® HPV HR TEST.
P990081|S010|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBITT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Normal 180 Day Track||N|01/03/2011|09/06/2011|||APPR|APPROVAL FOR THE PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY ASSAY MIGRATION TO THE BENCHMARK ULTRA AUTO STAINER, CHANGES TO PATHWAY HER-24 IN 1 CONTROL SLIDES, AND MINOR SOFTWARE UPDATES (VSS 11.7 TO 11.8).
P040037|S033|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|135 Review Track For 30-Day Notice||N|01/03/2011|04/20/2011|||APPR|APPROVAL FOR CHANGES TO THE STERILIZATION PROCESS.
P910001|S042|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2011|04/20/2011|||APPR|APPROVAL TO IMPLEMENT THE USE OF AN AUTOMATED METHOD INSTEAD OF A MANUAL METHOD OF DISPENSING EPOXY ADHESIVE.
P000020|S014|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION 2/SCORPION 2M ABLATION CATHETERS AND THE TEMPLINK/TEMPLINK M EXTENSION|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2011|03/17/2011|||OK30|ADDITION OF A NEW SUPPLIER FOR CONNECTOR ASSEMBLIES AND PLUG CABLE CONNECTORS.
P010030|S025|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/03/2011|06/29/2012|||APPR|APPROVAL FOR DESIGN CHANGES TO THE LIFEVEST GARMENT INCLUDING LOCATION OF THE REAR THERAPY PADS AND VIBRATION BOX, METHOD OF SECURING VIBRATION BOX TO GARMENT, ADJUSTMENT MECHANISM FOR SHOULDER STRAP, WIDTH OF ELASTIC STRAP AND RELATED LABELING CHANGES.
P890003|S211|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONICS CARELINK HOME MONITOR AND CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P010031|S228|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II/MAXIMO II/CONSULTA CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P820003|S104|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P970012|S081|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPGS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980016|S273|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II/SECURA/MAXIMO II ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980035|S200|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P010015|S107|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC CRT-P/INSYNC III CRT-P|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P850051|S074|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|MEDTRONIC CARELINK PROGRAMMER|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P930022|S012|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P060038|S009|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2011|02/03/2011|||OK30|ADDITION OF A SUPPLIER OF A DEVICE COMPONENT.
P980016|S274|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II VR/DR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2011|02/03/2011|||OK30|REDUCTION IN THE FREQUENCY OF A QUALITY CONTROL TEST FOR THE LASER RIBBON BONDING (LRB) PROCESS.
P010031|S229|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA/CONSULTA II/MAXIMO II/CONCERTO CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2011|02/03/2011|||OK30|REDUCTION IN THE FREQUENCY OF A QUALITY CONTROL TEST FOR THE LASER RIBBON BONDING (LRB) PROCESS.
P900061|S098|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P990001|S082|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C & T SERIES IPGS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980050|S057|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2011|05/13/2011|||APPR|APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P910001|S043|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2011|02/03/2011|||OK30|USE OF ADDITIONAL POUCH SEALING EQUIPMENT.
P040021|S016|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES|LWR|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2011|12/22/2011|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION SITE AND FOR FINAL PACKAGING OPERATIONS LOCATED AT ST. JUDE MEDICAL, PAMPULHA, BRAZIL.
P010047|S008|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2011|02/10/2011|||OK30|MARKETING OF PROGEL¿ APPLICATOR SPRAY TIPS AS AN ACCESSORY FOR THE NEOMEND PLEURAL AIR LEAK SEALANT DEVICE.
P060033|S063|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2011|04/20/2011|||APPR|APPROVAL FOR A MODIFICATION TO THE REGULATORY ELUTION SPECIFICATION.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER.
P060035|S005|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2011|05/20/2011|||APPR|APPROVAL FOR CHANGES TO MANUFACTURING METHODS AND PROCESS CHANGES.
P980041|S014|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/10/2011|02/07/2011|||APPR|APPROVAL TO ADD THE FOLLOWING NEW WARNING LABEL TO ALL ACCESS DXI SYSTEMS.  ¿WARNING¿ ERRONEOUS RESULTS CAN OCCUR IF REAGENT PACKS ARE NOT LOADED PROPERLY.  1) NEVER TRANSFER A PARTIAL REAGENT PACK THAT WAS USED ON A DIFFERENT SYSTEM.  2) ALWAYS LOAD A REAGENT PACK BEFORE SCANNING THE BAR CODE (ACCESS/ACCESS 2 ONLY).  FOR SPECIFIC INSTRUCTIONS, CONSULT THE SYSTEM DOCUMENTATION.
P970038|S013|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/10/2011|02/07/2011|||APPR|APPROVAL TO ADD THE FOLLOWING NEW WARNING LABEL TO ALL ACCESS DXI SYSTEMS.  ¿WARNING¿ ERRONEOUS RESULTS CAN OCCUR IF REAGENT PACKS ARE NOT LOADED PROPERLY.  1) NEVER TRANSFER A PARTIAL REAGENT PACK THAT WAS USED ON A DIFFERENT SYSTEM.  2) ALWAYS LOAD A REAGENT PACK BEFORE SCANNING THE BAR CODE (ACCESS/ACCESS 2 ONLY).  FOR SPECIFIC INSTRUCTIONS, CONSULT THE SYSTEM DOCUMENTATION.
P850048|S024|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/10/2011|02/07/2011|||APPR|APPROVAL TO ADD THE FOLLOWING NEW WARNING LABEL TO ALL ACCESS DXI SYSTEMS.  ¿WARNING¿  ERRONEOUS RESULTS CAN OCCUR IF REAGENT PACKS ARE NOT LOADED PROPERLY.  1) NEVER TRANSFER A PARTIAL REAGENT PACK THAT WAS USED ON A DIFFERENT SYSTEM.  2) ALWAYS LOAD A REAGENT PACK BEFORE SCANNING THE BAR CODE (ACCESS/ACCESS 2 ONLY).  FOR SPECIFIC INSTRUCTIONS, CONSULT THE SYSTEM DOCUMENTATION.
N16895|S092|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2011|02/09/2011|||OK30|CHANGE IN SUPPLIER LOCATION.
P960042|S025|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS II LASER SHEATH|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2011|02/09/2011|||OK30|CHANGE TO THE FUSING PROCESS FOR THE OUTER JACKET TUBING.
P040047|S018|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2011|05/17/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN STURTEVANT, WISCONSIN.
P950032|S062|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2011|02/10/2011|||OK30|ALTERNATE SUPPLIER FOR THE POLYCARBONATE BASE FILM USED IN THE MANUFACTURE OF A CULTURE INSERT.
P040006|S005|DEPUY SPINE,INC|325 PARAMONT DRIVE||RAYNHAM|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|IN MOTION LUMBAR ARTIFICIAL DISC|MJO|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2011|02/08/2011|||APPR|APPROVAL FOR THE CHANGE IN TOLERANCE OF THE IMPLANT DIMENSIONS AND THE SUBSEQUENT INDEPENDENT INSPECTION OF THESE DIMENSIONS.
P050037|S026|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2011|03/14/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN STURTEVANT, WISCONSIN.
P050052|S029|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2011|03/14/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN STURTEVANT, WISCONSIN.
P040047|S019|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2011|05/17/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN STURTEVANT, WISCONSIN.
P050037|S027|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2011|03/14/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN STURTEVANT, WISCONSIN.
P050052|S030|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2011|03/14/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN STURTEVANT, WISCONSIN.
P990020|S044|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2011|02/07/2011|||OK30|CHANGE TO SAMPLE NUMBERS FOR ENDOTOXIN TESTING AND A LOT DEFINITION CHANGE.
P070007|S027|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2011|02/07/2011|||OK30|CHANGE TO SAMPLE NUMBERS FOR ENDOTOXIN TESTING AND A LOT DEFINITION CHANGE.
P070027|S028|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2011|02/07/2011|||OK30|CHANGE TO SAMPLE NUMBERS FOR ENDOTOXIN TESTING AND A LOT DEFINITION CHANGE.
P100021|S001|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2011|02/07/2011|||OK30|CHANGE TO SAMPLE NUMBERS FOR ENDOTOXIN TESTING AND A LOT DEFINITION CHANGE.
P980041|S015|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/12/2011|02/04/2011|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:  1) MODIFY THE FLUIDICS INTERCONNECT PANELS TO ADD TUBE CLIPS; 2) ADDITIONAL TUBING LABELS WHICH CORRESPOND WITH FLUIDIC INTERCONNECT PANEL; 3) ADD STRAIN RELIEF AS A BEND DETERRENT; AND 4) UPDATE MAINTENANCE DOCUMENTATION TO REFLECT MODIFIED CONFIGURATION.
P970038|S014|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/12/2011|02/04/2011|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:  1) MODIFY THE FLUIDICS INTERCONNECT PANELS TO ADD TUBE CLIPS; 2) ADDITIONAL TUBING LABELS WHICH CORRESPOND WITH FLUIDIC INTERCONNECT PANEL; 3) ADD STRAIN RELIEF AS A BEND DETERRENT; AND 4) UPDATE MAINTENANCE DOCUMENTATION TO REFLECT MODIFIED CONFIGURATION.
P850048|S025|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/12/2011|02/04/2011|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:  1) MODIFY THE FLUIDICS INTERCONNECT PANELS TO ADD TUBE CLIPS; 2) ADDITIONAL TUBING LABELS WHICH CORRESPOND WITH FLUIDIC INTERCONNECT PANEL; 3) ADD STRAIN RELIEF AS A BEND DETERRENT; AND 4) UPDATE MAINTENANCE DOCUMENTATION TO REFLECT MODIFIED CONFIGURATION.
P100010|S001|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM|OAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/12/2011|08/23/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000058|S042|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2011|03/15/2012|||OK30|CHANGE TO DRUG TESTING BY ONE OF THE CONTRACT MANUFACTURERS.
P000054|S029|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2011|03/15/2012|||OK30|CHANGE TO DRUG TESTING BY ONE OF THE CONTRACT MANUFACTURERS.
P050053|S020|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2011|03/15/2012|||OK30|CHANGE TO DRUG TESTING BY ONE OF THE CONTRACT MANUFACTURERS.
P050047|S014|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2011|05/11/2011|||APPR|APPROVAL FOR THE REMOVAL OF AN IN- PROCESS QUALITY CONTROL TEST USED IN THE MANUFACTURE OF JUVÉDERM HYALURONATE GEL IMPLANTS.
P020056|S013|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2011|02/11/2011|||OK30|CHANGE IN THE TUBING USED IN THE GEL FILLING PROCESS.
P100021|S002|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/14/2011|05/09/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050044|S016|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/04/2011|||APPR|APPROVAL FOR AN ADDITIONAL IN- PROCESS INSPECTION OF THE TRANSFER SYRINGES TO VISUALLY CHECK THAT THE CAPS ARE PRESENT AND APPROPRIATELY TIGHTENED.
P080015|S003|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA|MAQ|MI|Real-Time Process||N|01/18/2011|02/03/2011|||APPR|APPROVAL FOR SEVERAL CHANGES TO THE CERVISTA HPV 16/18 SOFTWARE AND LABELING.  CHANGES INCLUDE THE COMPANY NAME CHANGE FROM THIRD WAVE TO HOLOGIC, NUMEROUS USER INTERFACE CHANGES, AND SEPARATING THE INVADER CALL REPORTER AND CERVISTA HPV 16/18 SOFTWARE ON TO SEPARATE CDS WITH NEW PART NUMBERS.
P890055|S028|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/18/2011|03/15/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050043|S004|MORRIS INNOVATIVE RESEARCH INC|907 W.SECOND ST||BLOOMINGTON|IN|47403||Device, hemostasis, vascular|FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2011|03/17/2011|||APPR|APPROVAL FOR: 1) REPLACING THE SEWN TWO-PIECE SMALL INTESTINE SUBMOCOSA (SIS) ASSEMBLY WITH A SINGLE SIS PIECE; 2) DECREASING THE SIS CUFF LENGTH AND RIBBON WIDTH; 3) MODIFYING THE SIS PATCH TO RELEASE WIRE CONNECTION; AND 4) CHANGING THE SHEATH MATERIAL FROM A HIGH DENSITY POLYETHYLENE (HDPE) TO FLUORINATED ETHYLENE PROPYLENE (FEP).
P010031|S230|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/MAXIMO II/CONSULTA CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/10/2011|||OK30|UPDATES TO TEST SOFTWARE USED DURING FINAL FUNCTIONAL DEVICE TESTING.
P980016|S275|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II/SECURA/MAXIMO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/10/2011|||OK30|UPDATES TO TEST SOFTWARE USED DURING FINAL FUNCTIONAL DEVICE TESTING.
P890055|S029|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/18/2011|03/15/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980016|S276|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR/VIRTUOSO/ENTRUST/MARQUIS/MAXIMO/INTRINSIC ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/17/2011|||OK30|IMPLEMENTATION OF A DETECTION STEP IN THE BATTERY MANUFACTURING PROCESS AT A SUPPLIER.
P890055|S030|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/18/2011|03/15/2011|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL.
P010031|S231|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/MAXIMO II/CONSULTA/CONCERTO CRT-DS/INSYNC MAXIMO/SENTRY/INSYNC II MARQUIS/INSYNC III MARQUIS ICDS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/17/2011|||OK30|IMPLEMENTATION OF A DETECTION STEP IN THE BATTERY MANUFACTURING PROCESS AT A SUPPLIER.
P890055|S031|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/18/2011|02/12/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE MEDSTREAM REFILL KIT AND O.R. PREP KIT.  THE PMA SUPPLEMENT ALSO REQUESTED APPROVAL FOR STERILIZATION TO OCCUR AT STERIS ISOMEDIX SERVICES IN NORTHBOROUGH, MASSACHUSETTS AND KIT PACKAGING TO OCCUR AT CONTECH MEDICAL, INC., IN PROVIDENCE, RHODE ISLAND.
P980037|S034|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2011|03/17/2011|||APPR|APPROVAL FOR CHANGES TO THE ANGIOJET ULTRA CONSOLE SOFTWARE.
N18033|S052|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/14/2011|||OK30|IMPLEMENTATION OF AN AUTOMATED PROCESS FOR VERIFYING LOT DATA PRIOR TO PRINTING LABELS FOR VISTAKON® (ETAFILCON A) CONTACT LENSES.
N18033|S053|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/14/2011|||OK30|IMPLEMENTATION OF AN ALTERNATE TEST METHOD FOR DETERMINING THE PURITY IN THE RAW MATERIAL, METHACRYLIC ACID, USED IN THE VISTAKON® (ETAFILCON A) SOFT CONTACT LENSES.
P070009|S011|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BAND|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/18/2011|07/15/2011|||APPR|APPROVAL FOR THE REALIZE PRESSURE RECORDING SYSTEM, INDICATED TO RECORD AND DISPLAY FLUID PRESSURE VARIATIONS WITHIN A CLOSED SYSTEM BY CONVERTING MECHANICAL INPUTS TO ANALOG/DIGITAL ELECTRICAL SIGNALS.
P040014|S016|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/17/2011|||OK30|IMPLEMENT AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.IMPLEMENTATION OF AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.
P040042|S021|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/17/2011|||OK30|IMPLEMENT AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.IMPLEMENTATION OF AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.
P060019|S017|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2011|02/17/2011|||OK30|IMPLEMENT AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.IMPLEMENTATION OF AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.
P000039|S039|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL & CRIBRIFORM OCCLUDERS|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2011|02/18/2011|||OK30|USE OF NEW PATCH FORMING EQUIPMENT.
P020024|S031|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2011|02/18/2011|||OK30|USE OF NEW PATCH FORMING EQUIPMENT.
P040040|S016|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2011|02/18/2011|||OK30|USE OF NEW PATCH FORMING EQUIPMENT.
P850007|S031|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|SPINAL-STIM SPINAL FUSION SYSTEM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/19/2011|03/11/2011|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE GARMENT COVERING, THE TREATMENT COILS, LIQUID CRYSTAL DISPLAY, CONTROL UNIT HOUSING PROFILE, ORIENTATION OF THE CONTROLS, SOFTWARE/ FIRMWARE, POWER SUPPLY CORD, AND LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINAL-STIM AND IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS AND AS A NON-OPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE THE LAST SURGERY.
P030034|S005|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL-STIM CERVICAL FUSION SYSTEM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/19/2011|03/11/2011|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE GARMENT COVERING, THE TREATMENT COILS, LIQUID CRYSTAL DISPLAY, CONTROL UNIT HOUSING PROFILE, ORIENTATION OF THE CONTROLS, SOFTWARE/ FIRMWARE, POWER SUPPLY CORD, AND LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERVICAL-STIM AND IS INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSHION.
P050006|S019|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2011|02/18/2011|||OK30|ADDITION OF ALTERNATE POWDER FOR THE MANUFACTURING OF THE OCCLUDER.
P000037|S022|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2011|02/16/2011|||OK30|ADDED PRODUCTION CAPABILITY FOR TWO CURRENTLY OUTSOURCED MACHINING PROCESSES.
P060002|S017|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2011|02/16/2011|||OK30|CHANGES TO THE MANUFACTURING DATA ACCESS AND STORAGE SOFTWARE SYSTEMS.
P040037|S034|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2011|02/16/2011|||OK30|DUPLICATION OF A MANUFACTURING PROCESS AT AN ALTERNATE BUILDING WITHIN THE SAME COMPLEX.
P970021|S032|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2011|02/16/2011|||OK30|USE OF A NEW SUB- TIER SUPPLIER FOR THE PRINTED CIRCUIT BOARD ASSEMBLY.
P970003|S120|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2011|02/17/2011|||OK30|ADDITION OF ALTERNATE RAW MATERIALS AND REMOVAL OF ASSOCIATED CLEANING STEPS.
P990074|S023|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/24/2011|09/10/2013|||APPR|APPROVAL FOR PHYSICIAN AND PATIENT LABELING REVISIONS TO INCLUDE INFORMATION ABOUT ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) AND CONNECTIVE TISSUE DISEASE (CTD) RISKS WITH THE NATRELLE® SALINE-FILLED BREAST IMPLANT.
P980018|S012|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2011|02/11/2011|||OK30|AUTOMATED FILING OF DAB CHROMOGEN FOR HERCEPTEST AS THE PRIMARY FILING PROCESS.
P030035|S077|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2011|02/23/2011|||OK30|CHANGE TO THE SETSCREW AND SEPTUM INSTALLATION PROCESS.
P880086|S197|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2011|02/23/2011|||OK30|CHANGE TO THE SETSCREW AND SEPTUM INSTALLATION PROCESS.
P010031|S232|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT|NIK|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/24/2011|04/04/2012|12M-0814|07/31/2012|APPR|APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE AS FOLLOWS.FOR THE CONCERTO CRT-D MODEL C154DWK, CONSULTA CRT-D MODEL D224TRK, CONCERTO II CRT-D MODEL D274TRK, PROTECTA CRT-D MODEL D334TRG, PROTECTA CRT-D MODEL D334TRM, PROTECTA XT CRT-D MODEL D314TRG, PROTECTA XT CRT-D MODEL D314TRM, AND CONSULTA CRT-D MODEL D204TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE: THE CRT-D SYSTEM IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIASAND FOR PROVIDING CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE OPTIMAL MEDICAL THERAPY, AND MEET ANY OF THE FOLLOWING CLASSIFICATIONS: 1) NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASS III OR IV AND WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION.  2) LEFT BUNDLE BRANCH BLOCK (LBBB) WITH A QRS DURATION >= 130 MS, LEFT VENTRICULAR EJECTIONFRACTION <= 30%, AND NYHA FUNCTIONAL CLASS II. THE SYSTEM IS ALSO INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK FOR DEVELOPING ATRIAL TACHYARRHYTHMIAS. ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION. FOR THE MAXIMO II CRT-D MODEL D284TRK AND MAXIMO IICRT-D MODEL D264TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE:  (FOR ADDITIONAL INFORMATION, PLEASE SEE APPROVAL ORDER.)
P910077|S110|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2011|03/03/2011|||APPR|APPROVAL FOR MODIFICATION TO THE LATITUDE PATIENT MANAGEMENT SYSTEM REGULATED APPLICATION SOFTWARE V7.0.02 ON LATITUDE SYSTEM SERVER (MODEL 6488) AND RELATED COMMUNICATOR SOFTWARE CHANGES (MODEL 6476).
P030011|S010|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/18/2011|||OK30|RELOCATION OF SEVERAL CRITICAL MANUFACTURING OPERATIONS FROM BUILDING TO ANOTHER WITHIN THE SAME CORPORATE COMPLEX.
P070022|S010|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/16/2011|||OK30|CHANGE TO THE WORK INSTRUCTIONS FOR THE FLUID FILLING PROCESS OF THE DAMPER SUBASSEMBLY.
P890055|S032|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2011|05/10/2011|||APPR|APPROVAL FOR A NEW ADHESIVE TO SECURE THE ANTENNA AND MODIFICATION TO THE PIEZO ACTUATOR RELEASE SPECIFICATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR THE CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION (5.0 PH TO 7.0 PH) IN THE TREATMENT OF SEVERE SPASTICITY.
P980016|S277|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/SECURA/VIRTUOSO/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/24/2011|||OK30|REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.
P990001|S083|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+C-SERIES/VITATRON DA+T SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/24/2011|||OK30|REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.
P980035|S201|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 700/800/900/RELIA/SENSIA/SIGMA/VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/24/2011|||OK30|REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.
P010015|S108|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC/INSYNC II|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/24/2011|||OK30|REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.
P010031|S233|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONCERTO II/CONSULTA/INSYNC II MARQUIS/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/24/2011|||OK30|REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.
P890003|S212|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/24/2011|||OK30|REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.
P970012|S082|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2011|02/24/2011|||OK30|REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.
P050046|S009|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE STYLET ACCESSORY|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2011|06/29/2011|||APPR|APPROVAL FOR ACCEPTANCE OF A CHANGE TO RELOCATE A SENSOR ON WIRE GRINDING EQUIPMENT AND FORMALIZE INSPECTIONS AS ACCEPTANCE ACTIVITIES.
P040037|S035|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2011|02/18/2011|||OK30|DUPLICATION OF A SIMILAR MANUFACTURING PROCESS AT AN ALTERNATE LOCATION.
P060039|S021|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MODEL 4195 ATTAIN STARFIX LEAD|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/26/2011|11/22/2011|||APPR|APPROVAL FOR A CHANGE IN THE REQUIREMENT FOR THE COPPER CONTENT IN THE BLUE POLYURETHANE TUBING UTILIZED BY THE MEDTRONIC ATTAIN STARFIX LEAD FROM 200 PPM TO 300 PPM.
P050042|S009|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2011|02/17/2011|||OK30|CHANGE IN THE VENDORS FOR ANTIFOAM AND GOAT SERUM, AND A CHANGE IN A MATERIAL TEST METHOD.
P850079|S049|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|XCEL TORIC (METHAFILCON A) SOFT CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2011|03/16/2011|||OK30|CHANGE IN LOCATION OF THE WET PROCESSING AREA AND THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR FOR STERILIZATION RELEASE.
P010047|S009|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2011|04/13/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
P950022|S076|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA FAMILY OF HIGH VOLTAGE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2011|02/10/2011|||OK30|USE OF AN ALTERNATE SUPPLIER FOR A LEAD COMPONENT.
P930038|S065|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice||N|01/27/2011|02/18/2011|||OK30|REDUCTION IN THE FREQUENCY OF AN IN- PROCESS QUALITY CONTROL INSPECTION.
P970003|S121|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2011|02/28/2011|||OK30|CHANGE TO THE PULSE GENERATOR MANUFACTURING PROCESS.
P950029|S056|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT SR/DR PACERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2011|03/22/2011|||APPR|APPROVAL FOR A NEW SETSCREW AND TORQUE-LIMITING SCREWDRIVER ACCESSORY.
P010047|S010|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/28/2011|12/21/2011|||APPR|APPROVAL FOR THE PROGEL APPLICATOR EXTENDED SPRAY TIPS AS AN ACCESSORY FOR THE PROGEL PLEURAL AIR LEAK SEALANT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROGEL APPLICATOR EXTENDED SPRAY TIPS AND THE INDICATIONS FOR USE IS TO DELIVER PROGEL TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE (I.E. WITH SUTURES OR STAPLES) OF VISIBLE AIR LEAKS (>= 2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA IN ADULT HUMANS BY BENDING THE MALLEABLE TIP TO DIRECT PROGEL FROM THE DELIVERY TIP IN A STREAM OR SPRAY CONE PATTERN THAT IS PERPENDICULAR TO THE TARGET SURFACE.
P050044|S017|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2011|02/25/2011|||OK30|ADDITION OF AN ALTERNATE LOCATION FOR CONDUCTING TWO MICROBIOLOGICAL ASSAYS USED IN THE MANUFACTURE OF THE VITAGEL SURGICAL HEMOSTAT.
P050010|S011|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC - L TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2011|09/16/2011|||APPR|APPROVAL FOR A CHANGE TO A NEW CALIBRATION SOFTWARE PROGRAM.
P040024|S052|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/28/2011|07/18/2011|||APPR|APPROVAL FOR AN EXTENSION TO THE EXPIRATION DATE OF THE LIDOCAINE HYDROCHLORIDE RAW MATERIAL FROM 12 MONTHS TO 24 MONTHS.
P890055|S033|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2011|05/23/2011|||APPR|APPROVAL FOR SOFTWARE MODIFICATION TO THE MEDSTREAM PROGRAMMABLE INFUSION SYSTEM.  THE MODIFIED MEDSTREAM PUMP WILL HAVE SOFTWARE PS-100044 VERSION 3.06, THE MODIFIED CONTROL UNIT WILL HAVE SOFTWARE PS-100046 VERSION 3.00.  PS-100045 VERSION 3.04, PS-1000047 VERSION 3.09 AND PS-100021 VERSION 2.00. THE DEVICE,AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR THE CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION (5.0 PH TO 7.0PH) IN THE TREATMENT OF SEVERE SPASTICITY.
P970021|S033|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|02/25/2011|||OK30|CHANGE IN THE CLEANING SOLUTION USED IN REMOVING RESIDUE FROM THE HEATING WIRE DURING THE MANUFACTURING PROCESS.
P860003|S057|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2011|07/29/2011|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE THERAKOS CELLEX PHOTOPHERESIS SYSTEM.
P970027|S013|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|04/15/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P980007|S016|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|AXSYM FREE PSA|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|06/10/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P910007|S025|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|AXSYM TOTAL PSA|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|06/10/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P880047|S014|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|03/02/2011|||OK30|CHANGE IN THE DENSITY LIMIT FOR IRRADIATION SHIPPERS.
P070015|S056|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|03/03/2011|||OK30|CHANGE TO THE COATING MANUFACTURING PROCESS.
N12159|S027|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL ORIGINAL/SURGICEL FIBRILLAR/SURGICEL NU-KNIT ABSORBABLE HEMOSTATS|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|03/04/2011|||OK30|ALTERNATE CYCLE FOR THE DEHUMIDIFICATION OVEN.
P910001|S044|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|02/28/2011|||OK30|MODIFICATIONS TO THE GLASS PREFORM PROCESS.
P970003|S122|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|03/02/2011|||OK30|ADDITION OF A CLEANING STEP FOR THE PRINTED CIRCUIT BOARD.
P020004|S058|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCULDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|02/18/2011|||OK30|AUTOMATION FOR CRIMPING GOLD MARKER BANDS.
P950029|S057|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR/DR & ESPIRIT SR/DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|03/03/2011|||OK30|REMOVAL OF A HYBRID BAKING STEP, AND THE ADDITION OF A HYBRID CLEANING STEP.
P040033|S019|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING SYSTEM (BHR)|NXT|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/31/2011|04/01/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050012|S036|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|03/02/2011|||OK30|ALTERNATE VENDOR AND METHOD OF MANUFACTURE OF THE DISPOSABLE SEAL COMPONENT OF THE APPLICATOR ASSEMBLY OF THE SEVEN AND SEVEN PLUS SYSTEMS.  THE PROPOSED CHANGE APPLIES ONLY TO THE DISPOSABLE SEAL SUPPLIER AND THE METHOD OF MANUFACTURE; NEITHER THE MATERIALS NOR THE FINAL DESIGN OF THE DISPOSABLE SEAL ARE ALTERED.  SENSOR PERFORMANCE AND RELEASE SPECIFICATION WILL ALSO REMAIN UNCHANGED.
P980016|S278|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|03/02/2011|||OK30|CHANGE IN SUPPLIER COMPONENT TESTING.
P010031|S234|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|03/02/2011|||OK30|CHANGE IN SUPPLIER COMPONENT TESTING.
P950005|S032|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|WEBSTER ELECTROPHYSIOLOGY CATHETER/CELSIUS ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|03/03/2011|||OK30|ADDITION OF A SUPPLIER FOR CATHETER TIP ELECTRODES.
P010068|S022|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS DS ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|03/03/2011|||OK30|ADDITION OF A SUPPLIER FOR CATHETER TIP ELECTRODES.
P990025|S027|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|03/03/2011|||OK30|ADDITION OF A SUPPLIER FOR CATHETER TIP ELECTRODES.
P820060|S027|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AXSYM AFP|LOK|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|06/10/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P060003|S008|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM AUSAB|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|04/15/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P060012|S006|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|04/15/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P060009|S004|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT: 09VB BLDG: AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE-M 2.0|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|04/15/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P050049|S006|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM HBSAG/CONFIRMATORY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2011|04/15/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P030016|S019|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|VISIAN ICL|MTA|OP|Normal 180 Day Track||N|12/23/2010|05/05/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960042|S026|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|02/28/2011|||OK30|MODIFICATIONS TO THE GLASS PREFORM PROCESS.
P980016|S279|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II DR/II VR/SECURA DR/VR/VIRTUOSO/II DR/II VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|02/23/2011|||OK30|AUTOMATION OF AN ADDITIONAL PLATING LINE.
P010031|S235|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO CRT-D/CONCERTO II ICD/CONSULTA CRT-D/INSYNC II MARQUIS/PROTECT/INSYNC III MARQUIS/INSYNC MARQUIS/INSYNC MAXIMO||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|02/23/2011|||OK30|AUTOMATION OF AN ADDITIONAL PLATING LINE.
P980035|S202|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA IPG/ENRHYTHM/RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|02/23/2011|||OK30|AUTOMATION OF AN ADDITIONAL PLATING LINE.
P990001|S084|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DA+C SERIES & DA+T SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|02/23/2011|||OK30|AUTOMATION OF AN ADDITIONAL PLATING LINE.
P100010|S002|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOBLATION CATHETER|OAE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2011|04/01/2011|||APPR|APPROVAL FOR A DESIGN MODIFICATION OF THE THERMOCOUPLE WIRE BONDING TO THE GUIDEWIRE LUMEN.
P970037|S004|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA/DELFIA XPRESS HAFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2011|03/04/2011|||OK30|CHANGE IN THE SUPPLIER OF A RAW MATERIAL.
P970008|S055|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2011|03/02/2011|||OK30|REMOVE A TUBE TRIMMING STEP AND MOVE THE CONTROL UNIT KEYBOARD ASSEMBLY PROCESS IN HOUSE.
P030053|S011|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/19/2011|03/17/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050040|S001|INVITROGEN CORPORATION|3175 STALEY RD.||GRAND ISLAND|NY|14072||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|SPOT-LIGHT HER2 CISH KIT|NYQ|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2011|07/12/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN FREDERICK, MARYLAND.
P980035|S203|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/RELIA/SENSIA/VERSA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2011|03/03/2011|||OK30|IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE.
P100010|S003|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2011|03/09/2011|||OK30|CHANGE OF THE ADHESIVE USED TO SEAL THE VACUUM TUBE TO REAR STRAIN.
P030031|S031|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER FOR RADIOFREQUENCY ABLATION|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/03/2011|09/23/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970051|S067|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2011|03/02/2011|||OK30|CHANGES TO THE MANUFACTURING PROCESS FOR THE USE OF NEW SILICONE INJECTION MOLDING EQUIPMENT.
P960009|S108|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2011|04/04/2011|||APPR|APPROVAL FOR MINOR DESIGN, MANUFACTURING, AND LABELING CHANGES TO THE MODEL 3625 EXTERNAL TEST STIMULATOR IN ORDER TO ESTABLISH COMPLIANCE WITH FUNCTIONAL REQUIREMENTS IN THE HARMONIZED STANDARDS IEC ((NTERNATIONAL ELECTROTECHNICAL COMMISSION) 60601-1 AND IEC 60601-1-2.
P840001|S178|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2011|04/04/2011|||APPR|APPROVAL FOR MINOR DESIGN, MANUFACTURING, AND LABELING CHANGES TO THE MODEL 3625 EXTERNAL TEST STIMULATOR IN ORDER TO ESTABLISH COMPLIANCE WITH FUNCTIONAL REQUIREMENTS IN THE HARMONIZED STANDARDS IEC (INTERNATIONAL ELECTROTECHNICAL COMMISSION) 60601-1 AND IEC 60601-1-2.
P970004|S104|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2011|04/04/2011|||APPR|APPROVAL FOR MINOR DESIGN, MANUFACTURING, AND LABELING CHANGES TO THE MODEL 3625 EXTERNAL TEST STIMULATOR IN ORDER TO ESTABLISH COMPLIANCE WITH FUNCTIONAL REQUIREMENTS IN THE HARMONIZED STANDARDS IEC (INTERNATIONAL ELECTROTECHNICAL COMMISSION) 60601-1 AND IEC 60601-1-2.
P990004|S021|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P.|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2011|03/02/2011|||OK30|CHANGE IN PACKAGING LINE EQUIPMENT.
P010001|S008|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2011|02/25/2011|||OK30|ADDITION OF TWO ¿LIKE TO LIKE¿ MACHINES USED FOR THE FOLLOWING MANUFACTURING PROCESSES OF THE CERAMIC BALL HEADS: 1) GRINDING THE INNER BORE AND CHAMFER; AND 2) POLISHING THE OUTER BALL HEAD CONTOUR.
P910001|S045|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS LASER CATHETERS ELCA|LPC|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2011|07/14/2011|||APPR|APPROVAL FOR CHANGES TO PYROGEN TESTING PROCEDURES AND SAMPLING.
P960042|S027|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER CATHETERS SLS II LASER SHEATH|MFA|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2011|07/14/2011|||APPR|APPROVAL FOR CHANGES TO PYROGEN TESTING PROCEDURES AND SAMPLING.
P960042|S028|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS II SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2011|03/07/2011|||OK30|CHANGE THE PROCESS FOR DISPENSING FLUID ADHESIVE FROM A MANUAL METHOD TO A SEMI-AUTOMATED METHOD.
P840001|S179|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2011|03/09/2011|||OK30|IMPLEMENTATION OF AN ADDITIONAL AUTOMATED PLATING LINE AT THE PLATING SUPPLIER.
P860004|S146|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PROGRAMMABLE DRUG PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2011|03/09/2011|||OK30|IMPLEMENTATION OF AN ADDITIONAL AUTOMATED PLATING LINE AT THE PLATING SUPPLIER.
P960009|S109|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2011|03/09/2011|||OK30|IMPLEMENTATION OF AN ADDITIONAL AUTOMATED PLATING LINE AT THE PLATING SUPPLIER.
P970004|S105|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2011|03/09/2011|||OK30|IMPLEMENTATION OF AN ADDITIONAL AUTOMATED PLATING LINE AT THE PLATING SUPPLIER.
P840001|S180|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3/SYNERGY/SYNERGY VERSITREL IPG/RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCED INS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2011|03/09/2011|||OK30|MODIFICATION TO EPOXY DISPENSE EQUIPMENT PARAMETERS.
P100010|S004|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2011|04/08/2011|||APPR|APPROVAL FOR A DESIGN MODIFICATION OF GUIDE WIRE LUMEN MATERIALS.
P970004|S106|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/INTERSTIM II INS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2011|03/09/2011|||OK30|MODIFICATION TO EPOXY DISPENSE EQUIPMENT PARAMETERS.
P960009|S110|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA/KINETRA/ACTIVA PC/ACTIVA RC INS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2011|03/09/2011|||OK30|MODIFICATION TO EPOXY DISPENSE EQUIPMENT PARAMETERS.
P050020|S033|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2011|03/10/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF THE INJECTION MOLDED COMPONENTS OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM.
P000010|S019|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2011|08/17/2011|||APPR|APPROVAL FOR CHANGES MADE TO THE ACCEPTANCE CRITERIA FOR A CONJUGATE BULK SOLUTION USED IN THE DEVICE.
P070022|S012|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2011|03/09/2011|||OK30|ADDITION OF A MANUFACTURING STEP FOR THE ADIANA MATRIX COMPONENT.
P090003|S009|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2011|03/09/2011|||OK30|MODIFICATION IN THE BALLOON WINGFOLDING OPERATION DURING MANUFACTURE OF THE EXPRESS¿ LD ILIAC PREMOUNTED STENT SYSTEM.
P070009|S012|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER|LTI|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2011|03/31/2011|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE SUPPLIER FOR THE INJECTION MOLDING OF THE SEPTUM AND CONNECTOR SLEEVE COMPONENTS OF THE INJECTION PORT.
P070009|S013|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER|LTI|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2011|03/31/2011|||APPR|APPROVAL FOR A DEVICE CHANGE TO MODIFY THE SILICONE MATERIAL USED FOR THE INJECTION PORT SEPTUM AND INJECTION PORT CONNECTOR SLEEVE COMPONENTS, ALONG WITH A MINOR ASSOCIATED LABELING MODIFICATION.
P020036|S021|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2011|12/05/2011|||APPR|APPROVAL FOR A CHANGE IN THE MATERIAL COMPOSITION OF THE TUBING IN THE HEMOSTASIS VALVE.
N16895|S093|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2011|03/04/2011|||OK30|CHANGE TO TRANSFER RAW MATERIAL SUPPLIER PROCESSING FROM SARASOTA, FLORIDA, UNITED STATES TO GERMANY.
P050028|S013|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS AMPLIPREP/COBAS TAQMAN HBV TEST||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2011|02/24/2011|||OK30|ELIMINATION OF THE IN-PROCESS CHEMICAL TESTING OF THE BUFFER CONCENTRATE COMPONENT OF THE MASTER MIX USED WITH THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER (PMC) FACILITY IN BRANCHBURG, NEW JERSEY.
P060030|S015|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2011|02/24/2011|||OK30|ELIMINATION OF THE IN-PROCESS CHEMICAL TESTING OF THE BUFFER CONCENTRATE COMPONENT OF THE MASTER MIX USED WITH THE COBAS  TAQMAN HCV TEST, V2.0 WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER (PMC) FACILITY IN BRANCHBURG, NEW JERSEY.
P980037|S035|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANJIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2011|04/07/2011|||APPR|APPROVAL FOR CHANGES TO THE ANGIOJET ULTRA XMI THROMBECTOMY SET TRUSEAL INTRODUCER.
P980016|S280|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/2011|05/02/2012|||APPR|APPROVAL FOR MEDTRONIC PROTECTA¿ XT VR D314VRM, PROTECTA¿ VR D334VRM, SECURA® VR D204VRM, MAXIMO II® VR D264VRM ICD SYSTEMS, MODEL 9995 APPLICATION SOFTWARE V7.3 AND MODEL SW009 APPLICATION SOFTWARE VL.0 SYSTEMS.
P890003|S214|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/2011|05/02/2012|||APPR|APPROVAL FOR MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT® READER MODEL 2020A, AND MODEL 2491 DDMA
P070007|S028|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2011|03/03/2011|||OK30|ADDITION OF A LUBRICANT DURING ASSEMBLY OF THE CAPTIVA DELIVERY SYSTEM.
P960011|S018|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/10/2011|03/08/2011|||APPR|APPROVAL FOR THE INCLUSION OF DIRECTIONS FOR PROPER FINGER FLANGE ORIENTATION IN THE INSTRUCTIONS FOR USE.  IN ADDITIONAL APPROVAL TO CHANGE THE TRADE NAME OF THE DEVICE FROM BD 1% OVD SODIUM HYALURONATE TO BVI 1% OVD SODIUM HYALURONATE.
P930031|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2011|07/19/2011|||APPR|APPROVAL FOR A COMPONENT VENDOR FACILITY SITE CHANGE.
P980033|S018|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2011|07/19/2011|||APPR|APPROVAL FOR A COMPONENT VENDOR FACILITY SITE CHANGE.
P940019|S024|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2011|07/19/2011|||APPR|APPROVAL FOR A COMPONENT VENDOR FACILITY SITE CHANGE.
P860057|S076|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|GLUTARALDEHYDE SOLUTION SYSTEM|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2011|03/03/2011|||OK30|ADDITION OF A NEW VESSEL FOR THE GLUTERALDEHYDE MIXING PROCESS.
P930014|S047|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ TORIC INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2011|03/09/2011|||OK30|IMPLEMENTATION OF A SOFTWARE MODIFICATION TO ENHANCE AND IMPROVE INTRAOCULAR LENS PRODUCTION.
P040020|S030|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice||N|02/10/2011|03/09/2011|||OK30|IMPLEMENTATION OF A SOFTWARE MODIFICATION TO ENHANCE AND IMPROVE INTRAOCULAR LENS PRODUCTION.
P040044|S036|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2011|03/10/2011|||OK30|ADDITION OF A SUPPLIER FOR SUBASSEMBLIES OF THE MYNX PRODUCT FAMILY.
P030053|S012|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/2011|04/05/2013|||APPR|APPROVAL FOR THE 6-YEAR UPDATE PATIENT AND PHYSICIAN LABELING FOR THE MEMORYGEL¿ SILICONE GEL-FILLED BREAST IMPLANT.
P990075|S022|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED & SPECTRUM BREAST IMPLANTS|FWM|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/2011|10/08/2013|||APPR|APPROVAL FOR UPDATED LABELING INCORPORATING INFORMATION ON ANAPLASTIC LARGE CELL LYMPHOMA (ALCL).
P950008|S008|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2011|03/10/2011|||OK30|ESTABLISH ISO CLASSIFICATION FOR TWO CONTROLLED ENVIRONMENT AREAS.
P020047|S029|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX ML-8|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2011|06/16/2011|||APPR|APPROVAL TO REMOVE A REDUNDANT RECEIVING INSPECTION TEST.
P870072|S047|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2011|03/10/2011|||OK30|MOVING A MANUFACTURING PROCESS IN-HOUSE FROM A CONTRACT MANUFACTURER.
P070015|S058|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2011|06/16/2011|||APPR|APPROVAL TO REMOVE A REDUNDANT RECEIVING INSPECTION TEST.
P100010|S005|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/2011|03/24/2011|||APPR|APPROVAL FOR A LABELING CHANGE TO EXTEND THE SHELF-LIFE OF THE DEVICE.
P080032|S006|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/11/2011|04/07/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060008|S067|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/2011|08/12/2011|||APPR|APPROVAL FOR REVISED LABELING TO INCLUDE UPDATED CLINICAL TRIAL DATA THROUGH THE FINAL 5-YEAR TIME POINT FOR THE TAXUS ATLAS STUDY AND THROUGH THREE (3) YEARS FOR THE TAXUS ATLAS SMALL VESSEL AND LONG LESION STUDIES.
P040033|S020|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/2011|03/16/2011|||APPR|APPROVAL FOR REVISIONS TO THE SURGICAL TECHNIQUE MANUAL.
P990009|S031|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2011|03/16/2011|||OK30|CHANGES IN THE MANUFACTURING METHODS OR PROCESSES.
P000014|S023|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice||N|02/14/2011|03/10/2011|||OK30|CHANGE TO MANUFACTURE AND STORE THE ANTIFOAM SOLUTION USED IN VITROS ANTI-HBS CONJUGATE REAGENT.
P010019|S020|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2011|03/16/2011|||OK30|CHANGE THE ENDOTOXIN TESTING SITE TO THE CIBA VISION JOHOR MICROBIOLOGY LABORATORY IN JOHOR, MALAYSIA.
P100010|S007|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|Real-Time Process||N|02/15/2011|05/23/2011|||APPR|APPROVAL FOR CHANGES IN THE LEAK DETECTION CIRCUIT AND BLOOD SENSOR BOARD.
P070007|S029|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT WITH THE XCELERANT AND CAPTIVIA DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2011|08/18/2011|||APPR|APPROVAL FOR AUTOMATION OF YOUR INVENTORY MANAGEMENT SYSTEM.
P990020|S045|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2011|08/18/2011|||APPR|APPROVAL FOR AUTOMATION OF YOUR INVENTORY MANAGEMENT SYSTEM.
P100021|S004|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2011|08/18/2011|||APPR|APPROVAL FOR AUTOMATION OF YOUR INVENTORY MANAGEMENT SYSTEM.
P010031|S236|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/II ICD/CONSULTA CRT-D/MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2011|03/17/2011|||OK30|IMPLEMENTATION OF A NEW DEVICE MANUFACTURING ASSEMBLY LINE.
P020045|S036|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|UNIVERSAL CRYOCONSOLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2011|04/29/2011|||OK30|ADDITION OF AN ADDITIONAL CALIBRATION, CALIBRATION EQUIPMENT, AND ASSOCIATED DOCUMENTATION CHANGE.
P070027|S029|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2011|08/18/2011|||APPR|APPROVAL FOR AUTOMATION OF YOUR INVENTORY MANAGEMENT SYSTEM.
P000058|S043|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2011|08/03/2012|||APPR|APPROVAL FOR THE SUBSTITUTION OF A QUALITY CONTROL TEST.
P000054|S030|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2011|08/03/2012|||APPR|APPROVAL FOR THE SUBSTITUTION OF A QUALITY CONTROL TEST.
P050053|S021|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2011|08/03/2012|||APPR|APPROVAL FOR THE SUBSTITUTION OF A QUALITY CONTROL TEST.
P990064|S037|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS|LWR|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/15/2011|04/15/2011|||APPR|APPROVAL FOR MODIFICATIONS TO YOUR SECONDARY AND TERTIARY PACKAGING, INCLUDING THE ADDITION OF TWO NEW MATERIALS:  A TEMPERATURE INDICATOR (TO BE PLACED IN THE SECONDARY PACKAGE) AND A CLEAR END SEAL LABEL.
P980043|S030|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/15/2011|04/15/2011|||APPR|APPROVAL FOR MODIFICATIONS TO YOUR SECONDARY AND TERTIARY PACKAGING, INCLUDING THE ADDITION OF TWO NEW MATERIALS:  A TEMPERATURE INDICATOR (TO BE PLACED IN THE SECONDARY PACKAGE) AND A CLEAR END SEAL LABEL.
P970031|S032|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTICROOT BIOPROSTHESIS|LWR|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/15/2011|04/15/2011|||APPR|APPROVAL FOR MODIFICATIONS TO YOUR SECONDARY AND TERTIARY PACKAGING, INCLUDING THE ADDITION OF TWO NEW MATERIALS:  A TEMPERATURE INDICATOR (TO BE PLACED IN THE SECONDARY PACKAGE) AND A CLEAR END SEAL LABEL.
P980016|S281|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2011|03/17/2011|||OK30|IMPLEMENTATION OF A NEW DEVICE MANUFACTURING ASSEMBLY LINE.
P810002|S073|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE/SJM MASTERS SERIES & SJM REGENT HEART VALVES|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|04/08/2011|||OK30|REVISED STEAM STERILIZATION LOAD CONFIGURATION.
P810002|S074|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MASTERS VALVED GRAFT|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|07/18/2011|||APPR|APPROVAL FOR CHANGE TO THE STERILIZATION LOAD AND CONFIGURATION.
P060001|S011|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/16/2011|03/08/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P940015|S020|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC & SYNVISC-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/18/2011|||OK30|FILLING OF AN INVESTIGATIONAL DRUG ON THE INOVA FILLER MACHINE, WHICH IS ALSO USED FOR FILLING THE SYNVISC AND SYNVISC-ONE PRODUCTS.
P030029|S012|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/14/2011|||OK30|CHANGE OF RAW MATERIAL USED IN THE PRODUCTION OF THE LITE REAGENT BUFFER.
P020004|S059|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/16/2011|||OK30|REMOVAL OF A COOLING CHAMBER AND AN UPDATE TO THE TOUCH SCREEN SOFTWARE.
P040043|S038|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/16/2011|||OK30|REMOVAL OF A COOLING CHAMBER AND AN UPDATE TO THE TOUCH SCREEN SOFTWARE.
P980016|S282|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/24/2011|||OK30|ADD A DRY PLASMA OXYGEN CLEAN PROCESS STEP.
P980035|S204|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/24/2011|||OK30|ADD A DRY PLASMA OXYGEN CLEAN PROCESS STEP.
P010031|S237|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II ICD/CONSULTA/MAXIMO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/24/2011|||OK30|ADD A DRY PLASMA OXYGEN CLEAN PROCESS STEP.
P970012|S083|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/18/2011|||OK30|NEW MOLD AND AN ADDITIONAL SUPPLIER FOR SEAL COMPONENTS.
P980035|S205|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTA/ENPULSE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/18/2011|||OK30|NEW MOLD AND AN ADDITIONAL SUPPLIER FOR SEAL COMPONENTS.
P980016|S283|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/18/2011|||OK30|NEW MOLD AND AN ADDITIONAL SUPPLIER FOR SEAL COMPONENTS.
P840001|S181|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 INS/SYNERGY FAMILY INS/POCKET ADAPTORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/17/2011|||OK30|ADDITION OF A NEW MANUFACTURING MOLD AND COMPONENT SUPPLIER.
P970004|S107|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM INS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/17/2011|||OK30|ADDITION OF A NEW MANUFACTURING MOLD AND COMPONENT SUPPLIER.
P960009|S111|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC INS/SOLETRA INS/KINETRA INS/POCKET ADAPTORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2011|03/17/2011|||OK30|ADDITION OF A NEW MANUFACTURING MOLD AND COMPONENT SUPPLIER.
P070022|S013|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|07/05/2011|||APPR|APPROVAL FOR MINOR CHANGES TO A DAMPER TEST FIXTURE AND REVISION OF THE DAMPER ASSEMBLY PROCESS.
P050042|S010|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|03/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P050051|S009|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|03/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P080023|S006|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|03/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P060035|S006|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|03/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P060007|S007|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|03/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P980007|S017|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|06/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P980022|S093|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2011|10/14/2011|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PUMP CASE BOTTOM COVER TO REDUCE THE RIB (A) WIDTH DIMENSIONS, AFFECTING THE PARADIGM REAL-TIME PUMP MODELS MMT-722, MMT-722K, MMT-723 AND MMT-723K.
P910007|S026|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|06/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
P890070|S005|GRAIN PROCESSING CORP.|1600 OREGON ST.||MUSCATINE|IA|52761||POWDER, DUSTING, SURGICAL|PURE-DENT B851 ABSORBABLE DUSTING POWDER|KGP|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2011|10/07/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PACMOORE PROCESS TECHNOLOGIES, LLC. IN MOORESVILLE, INDIANA.
P100021|S005|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/16/2011|||OK30|ADDITION OF AN AUTOMATED CRIMPING MACHINE USED DURING THE RADIOPAQUE MARKER- BAND BOND PROCESS OF THE ENDURANT DELIVERY SYSTEM.
P040012|S036|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|07/28/2011|||APPR|APPROVAL FOR CHANGES TO YOUR SOLUTION MANUFACTURING PROCESS.
P980007|S018|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/07/2011|||OK30|CHANGE IN THE VENDOR OF ANTIFOAM RAW MATERIAL FOR USE IN THE ARCHITECT FREE PSA ASSAYS.
P090013|S001|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC REVO MRI PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/18/2011|||OK30|MULTIPLE CHANGES IN SUPPLIERS OF VARIOUS ELECTRONIC COMPONENTS.
P910007|S027|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/07/2011|||OK30|CHANGE IN THE VENDOR OF ANTIFOAM RAW MATERIAL FOR USE IN THE ARCHITECT TOTAL PSA.
P830055|S118|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|07/01/2011|||APPR|APPROVAL FOR A CHANGE TO A NEW DRAG FINISHING PROCESS AT THE CORK, IRELAND FACILITY.
P830055|S119|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|01/06/2012|||APPR|APPROVAL FOR CHANGES TO THE FINAL CLEANING AND PASSIVATION PROCESSES FOR THE FEMORAL DEVICE.
P060005|S004|SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED|GLYN RHONWY. LLANBERIS|CAERNARFON|GWYNEDD, LL55||4EL||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|IMMULITE/IMMULITE 2000 FREE PSA|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2011|04/26/2011|||APPR|APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL IMMULITE 2000 XPI ANALYZER, AS A FAMILY MEMBER OF THE CURRENTLY CLEARED IMMULITE 2000 ANALYZER.
P980016|S284|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/17/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P010007|S005|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|IMMULITE/IMMULITE 2000 AFP|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2011|04/26/2011|||APPR|APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL IMMULITE 2000 XPI ANALYZER, AS A FAMILY MEMBER OF THE CURRENTLY CLEARED IMMULITE 2000 ANALYZER.
P010031|S238|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/17/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P010051|S008|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBC|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2011|05/12/2011|||APPR|APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL, THE IMMULITE 2000 XPI ANALYZER, AS A NEW FAMILY MEMBER OF THE CURRENTLY APPROVED IMMULITE 2000 ANALYZER, TO BE USED WITH THE CURRENTLY APPROVED IMMULITE 2000 ANTI-HBC ASSAY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME  IMMULITE 2000 XPI ANTI-HBCE ASSAY AN IS INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS B VIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.
P090013|S002|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/17/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P980035|S206|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/17/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P010053|S007|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBC IGM|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2011|05/12/2011|||APPR|APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL, THE IMMULITE 2000 XPI ANALYZER, AS A NEW FAMILY MEMBER OF THE CURRENTLY APPROVED IMMULITE 2000 ANALYZER, TO BE USED WITH THE CURRENTLY APPROVED IMMULITE 2000 ANTI-HBC IGM ASSAY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2000 XPI ANTI-HBC IGM ASSAY AND IS INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE OR RECENT (USUALLY WITHIN 6 MONTHS) HEPATITIS B VIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.
P890003|S215|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2011|03/17/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P010052|S008|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBS|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2011|05/12/2011|||APPR|APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL, THE IMMULITE 2000 XPI ANALYZER, AS A NEW FAMILY MEMBER OF THE CURRENTLY APPROVED IMMULITE 2000 ANALYZER, TO BE USED WITH THE CURRENTLY APPROVED IMMULITE 2000 ANTI-HBS ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE IMMULITE 2000 XPI ANTI-HBS ASSAY AND IS INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE DETECTION OF ANTI-HBS AND IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.
P930027|S011|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMMULITE/IMMULITE 2000 PSA|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2011|04/26/2011|||APPR|APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL IMMULITE 2000 XPI ANALYZER, AS A FAMILY MEMBER OF THE CURRENTLY CLEARED IMMULITE 2000 ANALYZER.
P010050|S012|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|HBSAG|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2011|05/12/2011|||APPR|APPROVAL FOR INTRODUCTION OF A NEW INSTRUMENT MODEL, THE IMMULITE 2000 XPI ANALYZER, AS A NEW FAMILY MEMBER OF THE CURRENTLY APPROVED IMMULITE 2000 ANALYZER, TO BE USED WITH THE CURRENTLY APPROVED IMMULITE 2000 HBSAG ASSAY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME  IMMULITE 2000 HBSAG ASSAY AN IS INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS B VIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION.
P050007|S028|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM IFU|MGB|CV|Special (Immediate Track)||N|02/22/2011|03/24/2011|||APPR|APPROVAL TO ADD ADJUNCTIVE COMPRESSION LANGUAGE TO THE LABELING AND INSTRUCTIONS FOR USE.
P040016|S070|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2011|03/18/2011|||OK30|CHANGE IN BACTERIAL ENDOTOXIN TEST METHODOLOGY.
P090003|S010|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2011|03/18/2011|||OK30|CHANGE IN BACTERIAL ENDOTOXIN TEST METHODOLOGY.
P010014|S030|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2011|03/24/2011|||OK30|CHANGE TO THE HEAT SEALING OF BLISTER PACKS PROCEDURE BY ADDING A NEW BENCHTOP SEALER.
P900060|S041|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/28/2011|12/21/2011|||APPR|APPROVAL TO EXTEND THE MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY FROM 1.5 TESLA TO 3.0 TESLA AND TO INCORPORATE OTHER LABELING REVISIONS FOR THE PURPOSE OF UNIFYING AND REBRANDING THE US MARKET LABELS WITH OTHER, NON-US MARKET LABELS.
P960004|S048|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE II, STEROX, FINELINE II STEROX AND FINELINE II STEROX EZ|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2011|03/24/2011|||OK30|CHANGE FROM A SCRUB METHOD OF CLEANING A LEAD BODY TO A WIPE METHOD.
P980024|S005|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2011|04/18/2011|||APPR|APPROVAL FOR THE IMPLEMENTATION OF PROCESS CHANGES TO THE MANUFACTURE OF THE PATHVYSION HER-2 DNA PROBE KIT ASSAY, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, AND RNA REDUCTION STEP, NEW SONICATION EQUIPMENT, AND A NEW AMINATION/LABELING PROCEDURE.
P010033|S018|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB GOLD|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2011|08/23/2011|||OK30|CHANGE OF A VENDOR FOR GLUCOSE TESTING FROM AUSTRALIA TO USA.
P080027|S003|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK RAPID HCV ANTIBODY|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2011|10/20/2011|||APPR|APPROVAL FOR HOLD TIME EXTENSIONS FOR RAW MATERIAL, COMPONENTS AND IN-PROCESS MATERIAL FOR THE MANUFACTURING OF THE DEVICE.
P010030|S026|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2011|03/28/2011|||OK30|ADDITION OF A NEW THERMOFORMING MACHINE.
P030002|S023|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|NAA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2011|03/29/2011|||OK30|RELOCATION OF THE FINAL INSPECTION AND PRE-PACK OPERATION AT THE MANUFACTURING FACILITY LOCATED IN RANCHO CUCAMONGA, CALIFORNIA.
P780007|S045|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2011|05/13/2011|||OK30|UTILIZE THE DYE PENETRATION TEST METHOD FOR TESTING PACKAGE INTEGRITY.
P010012|S264|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY SPIRAL LEAD|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/24/2011|04/07/2011|||APPR|APPROVAL FOR REASSIGNMENT OF A MECHANICAL INPUT SPECIFICATION, SUTURE SLEEVE RESISTANCE TO CUT-THROUGH FROM THE SUTURE SLEEVE, TO THE LEAD BODY FOR THE ACUITY SPIRAL IMPLANTABLE LEAD.
P090013|S003|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC REVO MRI SURESCAN PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2011|03/25/2011|||OK30|UPGRADES TO VARIOUS MANUFACTURING PROCESS SOFTWARE VERSIONS.
P080011|S004|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2011|03/23/2011|||APPR|ALTERNATE LABELING AND PACKING SITE LOCATED AT COOPERVISION INC. IN WEST HENRIETTA, NEW YORK.
P030052|S004|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/25/2011|03/22/2011|||APPR|APPROVAL TO PROVIDE THE DEFINITION FOR THE PEPSIN ACTIVITY OF THE VYSIS PROTEASE REAGENT IN THE UROVYSION PACKAGE INSERT.
P050051|S010|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2011|03/23/2011|||OK30|CHANGES IN TWO QUALITY CONTROL TEST METHODS USED FOR IN-PROCESS TESTING OF BULK COMPONENTS.
P970003|S123|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2011|03/25/2011|||OK30|CHANGE TO THE PULSE GENERATOR MANUFACTURING PROCESS.
P860004|S147|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC INTRATHECAL CATHETERS|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2011|01/20/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CO., IN JUNCOS, PUERTO RICO.
P830061|S060|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/VITATRON CRYSTALINE & EXCELLENCE PS+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P850089|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/Z NOVUS/VITATRON EXCELLENCE SS+/IMPULSE II|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P920015|S073|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P900061|S099|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACCESSORY-UPSIZING SLEEVE/LEAD END PIN CAP|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P890003|S216|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE/CAPSURE MODEL/SERVICE KIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P930039|S048|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P950024|S028|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P980050|S058|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P010015|S109|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P030036|S026|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P080006|S020|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P090013|S004|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P060011|S001|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7||intraocular lens|C-FLEX INTRAOCULAR LENS MODEL 570C|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/31/2011|||OK30|ALTERNATIVE OPTICAL MEASUREMENT EQUIPMENT.
P040012|S037|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|CHANGES TO THE IN- PROCESS INSPECTION AND SPECIFICATION FOR THE INNER MEMBER (IM) TO HYPOTUBE BOND OF THE ACCULINK CAROTID STENT SYSTEM.
P060039|S022|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P040012|S038|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|ADDITION OF AN ALTERNATE HEAT SEALER.
P040038|S021|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|ADDITION OF AN ALTERNATE HEAT SEALER.
P890064|S025|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/29/2011|||OK30|CHANGES FOR DIGENE® HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE® HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST LOCATED IN GAITHERSBURG, MD.
P860004|S148|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/22/2011|||OK30|ADDITION OF TWO NEW LASER WELDING WORKSTATIONS AND TWO NEW LASER POWER SUPPLIES TO THE MANUFACTURING PROCESS OF THE IMPLANTABLE SYNCHROMED II INFUSION PUMP, MODEL 8637.
P970013|S039|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY FAMILY OF PACEMAKERS|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/30/2011|||OK30|ALTERNATE SUPPLIER FOR PACE WIRES.
P070022|S014|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|09/06/2011|||APPR|APPROVAL FOR MINOR CHANGES TO THE SUGAR MOLD MANUFACTURING PROCESS.
P020004|S060|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/18/2011|||OK30|AUTOMATION OF A TRIMMING PROCESS.
P980049|S063|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ISOLINE 2CT & 2 CR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/31/2011|||OK30|UPDATE TO THE CURRENT LEADS LABEL PRINTING SOFTWARE.
P060027|S030|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|OVATIO CARDIAC RESYNCHRONIZATION THERAPY (CRT) AND SITUS OVER THE WIRE (OTW) LEFT VENTRICULAR (LV) LEAD|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/31/2011|||OK30|UPDATE TO THE CURRENT LEADS LABEL PRINTING SOFTWARE.
P020030|S008|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|STELID II BFT/BJF/STELIX BR/STELIX II BRF|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|03/31/2011|||OK30|UPDATE TO THE CURRENT LEADS LABEL PRINTING SOFTWARE.
P920047|S045|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER PRIME HTD CARDIAC ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|08/12/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION IN HEREDIA, COSTA RICA.
P020025|S026|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP CARDIAC ABLATION CATHETER|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2011|08/12/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION IN HEREDIA, COSTA RICA.
P890064|S026|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2011|04/20/2011|||APPR|APPROVAL FOR SOFTWARE DESIGN CHANGE OF THE HC2 SYSTEM SUITE CONSISTING OF AN HC2 SYSTEM SOFTWARE UPGRADE FROM VERSION 2.0 TO VERSION 3.0.
P030017|S116|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRESCISION SPINAL CORD STIMULATOR SYSTEM (SCS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/28/2011|||OK30|ADDITION OF AN ALTERNATE ASSEMBLY METHOD FOR THE LEADS AND EXTENSIONS FOR THE PRECISION® SPINAL CORD STIMULATOR (SCS) SYSTEM.
P030017|S117|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRESCISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/30/2011|||OK30|ADDITION OF POUCH SEALING EQUIPMENT FOR THE IN-HOUSE PROCESSING OF PRODUCTS PACKAGED IN TYVEK POUCHES.
P090013|S005|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC REVO MRI SURESCAN PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/28/2011|||OK30|CHANGES TO ALIGN PRODUCTION WITH EXISTING PROCESSES USED IN OTHER MARKETED DEVICES.
P010019|S021|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2011|09/09/2011|||APPR|APPROVAL FOR A TRADE NAME CHANGE TO THE (LOTRAFILCON B) SOFT CONTACT LENSES WITH WETTING AGENT IN PACKAGE SALINE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) AND IS INDICATED FOR THE FOLLOWING:  CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM THAT DOES NOT INTERFERE WITH VISUAL ACUITY.  CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) TORIC SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO 6.00 DIOPTERS (D) OR LESS OF ASTIGMATISM. CIBA VISION AIR OPTIX  AQUA (LOTRAFILCON B) MULTIFOCAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) AND/OR PRESBYOPIA IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY REQUIRED A READING ADDITION OF +3.00 DIOPTERS (D) OR LESS AND WHO MAY HAVE UP TO APPROXIMATELY 1.50 DIOPTERS OF ASTIGMATISM.  CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) MULTIFOCAL TORIC SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA, ASTIGMATISM, AND PRESBYOPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES.  THE LENSES MAY BE WORN BY PERSONS WHO HAVE 10.00 DIOPTERS (D) OR LESS OF REFRACTIVE AND/OR CORNEAL ASTIGMATISM. THE LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR FOR UP TO 6 NIGHTS OF CONTINUOUS WEAR WITH REMOVAL FOR DISPOSAL, OR CLEANING AND DISINFECTION (CHEMICAL, NOT HEAT) PRIOR TO REINSERTION, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL.
P910073|S093|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|05/03/2011|||OK30|REPLACE THE EXISTING AUTOMATED OPTICAL MEASURING SYSTEM WITH A NEW SYSTEM.
P090013|S006|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC REVO MRI SURESCAN PACING SYSTEM|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|04/15/2011|||APPR|APPROVAL FOR THE RELOCATION OF A STERILIZER SYSTEM AND AN ADDITIONAL BPA SUPPLIER.
P060033|S064|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2011|06/02/2011|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (WITH THE LATEST AVAILABLE FOLLOW-UP CLINICAL DATA FROM THE ENDEAVOR CLINICAL TRIAL PROGRAMS).
P060007|S008|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/30/2011|||OK30|SPECIFICATION CHANGE FOR THE NEGATIVE HUMAN PLASMA FOR THE HBSAG ASSAYS.
P060007|S009|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS|LOM|MI|30-Day Notice||N|03/01/2011|03/30/2011|||OK30|TEST METHOD CONVERSIONS FOR CALF BOVINE SERUM FOR THE TWO HBSAG ASSAYS.
P060007|S010|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/30/2011|||OK30|PLASMA TEST METHOD CONVERSIONS FOR ARCHITECT HBSAG AND ARCHITECT HBSAG CONFIRMATORY ASSAYS.
P060007|S011|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/30/2011|||OK30|TEST METHOD CHANGE FOR QUANTITATING ANTI-D AND ANTI-Y MONOCLONAL ANTIBODIES WHICH ARE USED IN THE TESTING OF THE RECOMBINANT HBSAG SUBTYPE AD (CODE 98034) AND HBSAG SUBTYPE AY (CODE 98035) ANTIGENS USED IN THE ARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAYS.
P050040|S002|INVITROGEN CORPORATION|3175 STALEY RD.||GRAND ISLAND|NY|14072||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|SPOT-LIGHT HER2 CISH KIT|NYQ|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2011|04/29/2011|||APPR|APPROVAL FOR CHANGES IN THE PRODUCT INSERT: 1) MANUFACTURING ADDRESS CHANGE; 2) COPYRIGHT CHANGE FROM INVITROGEN CORPORATION TO LIFE TECHNOLOGIES.  INVITROGEN WILL REMAIN THE BRAND NAME AND THEREFORE IS STILL INCLUDED ON THE PRODUCT INSERT AND LABELING; AND AN ADDITION OF LITERATURE REFERENCES TO THE BIBLIOGRAPHY.
P010068|S023|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR, CELSIUS, QWIKSTAR, EZ STEER BI-DIRECTIONAL, NAVISTAR RMT DUAL SENOR (8MM) DIAGNOSTIC/ABLATION DEFLECTABLE|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|02/08/2012|||APPR|APPROVAL FOR AN INCREASE IN THE NUMBER OF ALLOWED ETO STERILIZATION CYCLES, AND A MODIFICATION TO THE WORKMANSHIP INSPECTION PERFORMED BY QUALITY CONTROL.
P950005|S033|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE 4MM TIP CATHETERS/CELSIUS RMT DIAGNOSTIC/ABLATION STEERABLE TIP|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|02/08/2012|||APPR|APPROVAL FOR AN INCREASE IN THE NUMBER OF ALLOWED ETO STERILIZATION CYCLES, AND A MODIFICATION TO THE WORKMANSHIP INSPECTION PERFORMED BY QUALITY CONTROL.
P950032|S063|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/01/2011|04/06/2011|||APPR|APPROVAL FOR THE INTRODUCTION OF KERATINOCYTE CELL STRAIN (HEP071) INTO THE MANUFACTURE OF APLIGRAF.
P050028|S015|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0|MKT|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|07/12/2012|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS OF BULK CAPG GNR WASH REAGENT.
P060030|S016|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|07/12/2012|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING PROCESS OF BULK CAPG GNR WASH REAGENT.
P100021|S006|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/18/2011|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P040043|S039|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2011|08/23/2011|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE TAG THORACIC ENDOPROSTHESIS. THE TAG DEVICE IS INDICATED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING ADEQUATE ILIAC/ FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM, AND >= 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.
P070007|S030|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/18/2011|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P090006|S005|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/18/2011|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P000010|S020|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST V2.0/COBAS AMPLICOR HCV TEST V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/22/2011|||OK30|DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.
P000012|S029|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/22/2011|||OK30|DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.
P050028|S016|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722||COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/22/2011|||OK30|DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.
P060030|S017|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|03/22/2011|||OK30|DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.
P010068|S024|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EZ STEER NAV DS AND QWIKSTAR DS CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|04/06/2011|||OK30|ADDITION OF A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS.
P030031|S032|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|04/06/2011|||OK30|ADDITION OF A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS.
P040036|S023|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|04/06/2011|||OK30|ADDITION OF A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS.
P950005|S034|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION/INTERFACE CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|04/06/2011|||OK30|ADDITION OF A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS.
P990025|S028|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR/RMT/EZ STEER NAV/QWIKSTAR/INTERFACE CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|04/06/2011|||OK30|ADDITION OF A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS.
P990071|S012|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|INTERFACE CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2011|04/06/2011|||OK30|ADDITION OF A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS.
P010029|S012|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|04/01/2011|||OK30|ALTERNATE RHEOMETER FOR TESTING IN-PROCESS CONTROL AND FINISHED PRODUCT SAMPLES.
P960011|S019|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|04/01/2011|||OK30|ALTERNATE RHEOMETER FOR TESTING IN-PROCESS CONTROL AND FINISHED PRODUCT SAMPLES.
P980022|S095|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM SOF-SENSOR, GLUCOSE SENSORS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|03/30/2011|||OK30|CHANGE TO USE A SEMI-AUTOMATED TAPE APPLICATION DURING SENSOR BASE ASSEMBLY.
P090013|S007|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC REVO MRI SURESCAN PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|03/31/2011|||OK30|REVISING PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.
P050034|S005|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE (IMT)|NCJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|03/31/2011|||OK30|CHANGE THE BIOLOGICAL INDICATOR USED IN THE STERILIZATION PROCESS AND TO ADD AN OPTION FOR A SECOND FULL CYCLE STERILIZATION (DOUBLE STERILIZATION) TO THE MANUFACTURING PROCESS IF REQUIRED.
P980016|S285|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|03/31/2011|||OK30|ADDITION OF A NEW EQUIPMENT CONTROLLER FOR THE PRINT LABEL FILES.
P090013|S008|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|03/31/2011|||OK30|ADDITION OF A NEW EQUIPMENT CONTROLLER FOR THE PRINT LABEL FILES.
P010031|S239|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|03/31/2011|||OK30|ADDITION OF A NEW EQUIPMENT CONTROLLER FOR THE PRINT LABEL FILES.
P990001|S085|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+C & VITATRON DA+T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|03/31/2011|||OK30|ADDITION OF A NEW EQUIPMENT CONTROLLER FOR THE PRINT LABEL FILES.
P980035|S207|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/RELIA/SENSIA/VERSA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|03/31/2011|||OK30|ADDITION OF A NEW EQUIPMENT CONTROLLER FOR THE PRINT LABEL FILES.
P880086|S198|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2011|08/02/2011|||APPR|APPROVAL FOR ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT.
P030035|S078|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2011|08/02/2011|||APPR|APPROVAL FOR ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT.
P910023|S256|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CURRENT/FORTIFY FAMILIES OF ICDS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2011|08/02/2011|||APPR|APPROVAL FOR ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT.
P030054|S180|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2011|08/02/2011|||APPR|APPROVAL FOR ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT.
P080013|S004|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2011|09/29/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COVIDIEN, LP IN NORTH HAVEN, CONNECTICUT.
P060008|S068|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/03/2011|03/11/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960022|S008|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS 66 & SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2011|03/28/2011|||OK30|CHANGE WITH THE SUPPLIER OF THE RAW MATERIAL PROCESSING FOR THE SOFLENS66 AND SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES.
P970020|S061|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ZETA RX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2011|03/18/2011|||OK30|CHANGE IN RESIN VERIFICATION AT RECEIVING INSPECTION.
P020047|S030|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION/MINI VISION/MULTI-LINK 8TM/8TM LL/8TM SV CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2011|03/18/2011|||OK30|CHANGE IN RESIN VERIFICATION AT RECEIVING INSPECTION.
P070015|S059|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2011|03/18/2011|||OK30|CHANGE IN RESIN VERIFICATION AT RECEIVING INSPECTION.
P020047|S031|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION/MINI VISION/8TM/8TMLL/8TM SV CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2011|03/18/2011|||OK30|CHANGE IN QUALITY CONTROL TESTING FOR BALLOON RUPTURE.
P100021|S007|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2011|03/18/2011|||OK30|IMPROVEMENTS UPON THE CURRENT PROCESS FOR STENT GRAFT LOADING.
P020047|S032|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX; ML-8|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2011|05/19/2011|||APPR|APPROVAL TO REMOVE A REDUNDANT VERIFICATION STEP FOR A SPIRAL MANDREL USED IN THE STENT MANUFACTURING PROCESS.
P070015|S060|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2011|05/19/2011|||APPR|APPROVAL TO REMOVE A REDUNDANT VERIFICATION STEP FOR A SPIRAL MANDREL USED IN THE STENT MANUFACTURING PROCESS.
P970021|S034|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2011|04/05/2011|||OK30|A MANUFACTURING LOCATION CHANGE OF A RAW MATERIAL SUPPLIER.
P060009|S005|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT: 09VB BLDG: AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE-M 2.0|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2011|04/04/2011|||OK30|CHANGES TO REPLACE REAGENTS FOR IN- PROCESS TESTING OF THE HBV CORE ANTIGEN (ANTI-HBC) SPECIFIC ACTIVITY AND TO ALLOW THE USE OF TWO ALTERNATIVE PRECURSORS FOR MANUFACTURING OF THE PURIFIED FILTERED HBC IGG WITHIN THE ABBOTT PARK, ILLINOIS MANUFACTURING FACILITY.
P890003|S217|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MODEL 2490C/G/H/J CARELINK REMOTE HOME MONITOR/2020A ANALYZER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2011|04/06/2011|||OK30|THE TRANSFER OF FINAL DEVICE PACKAGING INSPECTION ACTIVITIES.
P960007|S021|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE|MGR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2011|09/20/2011|||APPR|APPROVAL FOR CHANGING FROM THE USE OF FETAL BOVINE SERUM TO THE USE OF BOVINE CALF SERUM AS A MEDIA SUPPLEMENT FOR EXPANDING CELLS IN EXPANDED SURFACE ROLLER BOTTLES, I.E., THE CELL EXPANSION PROCESS.
P050028|S017|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0|MKT|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2011|07/07/2011|||APPR|APPROVAL FOR CHANGES TO IN-PROCESS TESTING PROCEDURES FOR THE ELUTION BUFFER AND MANGANESE REAGENT TO BE IMPLEMENTED AT THE MANUFACTURING SITE IN SOMERVILLE, NEW JERSEY.
P080004|S006|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|HOYA ISPHERIC INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2011|04/07/2011|||OK30|CHANGES TO THE PREVIOUSLY APPROVED TEST LABORATORY AND TO THE LAL TEST METHOD.
P980035|S208|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA & RELIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2011|04/04/2011|||OK30|UPGRADES TO TEST SYSTEM HARDWARE AND SOFTWARE.
P040001|S019|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS SPACER SYSTEM|NQO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2011|05/04/2011|||APPR|APPROVAL FOR IMPLEMENTATION OF NEW INSTRUMENT CLEANING AND STERILIZATION PROCESSES AND IS INDICATED FOR TREATMENT OF PATIENTS AGED 50 OR OLDER SUFFERING FROM NEUROGENIC INTERMITTENT CLAUDICATION SECONDARY TO A CONFIRMED DIAGNOSIS OF LUMBAR SPINAL STENOSIS (WITH X-RAY, MRI, AND/OR CT EVIDENCE OF THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CANAL NARROWING).  THE X-STOP SPACER IS INDICATED FOR THOSE PATIENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/ BUTTOCK/GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND HAVE UNDERGONE A REGIMEN OF AT LEAST 6 MONTHS OF NONOPERATIVE TREATMENT.  THE X-STOP SPACER MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.
P860003|S058|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2011|04/21/2011|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION SITE LOCATED AT STERIGENICS US LLC IN CHARLOTTE, NORTH CAROLINA.
P980035|S209|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/RELIA/SENSIA/VERSA|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2011|05/19/2011|||APPR|APPROVAL FOR UPDATE OF THE EEPROM SERIAL NUMBER.
P050047|S015|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2011|03/25/2011|||APPR|APPROVAL FOR SOME LABELING UPDATES TO IMPROVE THE SAFE USE OF THE DEVICE.
P000039|S041|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|30-Day Notice||N|03/09/2011|04/08/2011|||OK30|MODIFICATIONS TO POUCH SEALING EQUIPMENT.
P020024|S033|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice||N|03/09/2011|04/08/2011|||OK30|MODIFICATIONS TO POUCH SEALING EQUIPMENT.
P040040|S018|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice||N|03/09/2011|04/08/2011|||OK30|MODIFICATIONS TO POUCH SEALING EQUIPMENT.
P960013|S064|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|1782 TENDRIL LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2011|04/06/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE CONNECTOR RING CRIMP CORE.
P950037|S094|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA FAMILY OF PULSE GENERATORS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2011|04/06/2011|||OK30|NEW SUPPLIER SITE FOR THE MANUFACTURE OF ELECTRICAL MODULES.
P070014|S022|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/10/2011|09/16/2011|||APPR|APPROVAL FOR THE ADDITION OF A 200 MM LENGTH STENT AND A NEW DELIVERY SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BARD LIFESTENT SOLO VASCULAR STENT SYSTEM AND IS INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DENOVO OR RESTENOTIC LESIONS UP TO 240 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 - 6.5 MM.
P970051|S068|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|COCHLEAR NUCLEUS 5 COCHLEAR IMPLANT SYSTEM|MCM|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/10/2011|04/07/2011|||APPR|APPROVAL FOR ADDITIONAL LABELING FOR THE CI500 SERIES COCHLEAR IMPLANT.
N18033|S054|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) CONTACT LENSES/CLEAR & VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2011|04/07/2011|||OK30|CHANGE IN THE SAMPLING FREQUENCY OF AN IN-PROCESS QUALITY AUDIT.
P040044|S037|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX CADENCE VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/2011|04/05/2011|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO MODIFY THE ADVANCER TUBE TO INCORPORATE A DUAL SLIT DESIGN AT THE PROXIMAL END OF THE ADVANCER TUBE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNX CADENCE VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH.
P080007|S005|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2011|09/02/2011|||APPR|APPROVAL FOR TWO CHANGES TO THE VALIDATED ETO STERILIZATION CYCLE (#14) CHAMBER PRESSURE PARAMETERS, FOR THE DEVICE.
P050039|S005|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2011|03/31/2011|||APPR|APPROVAL FOR LABELING CHANGES WHICH ADD STRENGTHENING LANGUAGE TO THE FEMORAL STEM SURGICAL TECHNIQUE MANUALS.
P930038|S066|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2011|04/08/2011|||OK30|ELIMINATION OF A COMPONENT CLEANING.
P030017|S118|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/11/2011|05/09/2011|||APPR|APPROVAL FOR A CHANGE IN THE OUTER BOX USED AS SECONDARY PACKAGING FOR LEAD AND EXTENSIONS.
P860003|S059|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/14/2011|05/13/2011|||APPR|APPROVAL FOR A MINOR DIMENSIONAL CHANGE TO A Y-ADAPTOR IN THE CELLEX PROCEDURAL KIT AND A CHANGE IN THE SPLICE BOND BUSHING OF THE CELLEX PROCEDURAL KITS ANTICOAGULANT (GREEN) LINE.
P970004|S108|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II, MODEL 3058 NEUROSTIMULATOR|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2011|08/19/2011|||APPR|APPROVAL FOR CHANGES TO THE PROCEDURE FOR CONFIRMING THAT THE ULTRASONIC STAKING OF TWO WASHERS HAS BEEN PERFORMED AND A MODIFICATION OF A TOOL USED TO ENSURE THE SETSCREW IS PRESENT IN THE SETSCREW BLOCK.
P020004|S061|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2011|04/08/2011|||OK30|AUTOMATION OF THE TRIMMING PROCESS DURING THE TRUNK WRAPPING AND FORMING STEP.
P950029|S058|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2011|04/08/2011|||OK30|UPDATE TO THE ELECTRONIC HYBRID MODULE CLEANING PROCESS.
P020026|S083|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/2011|05/27/2011|||APPR|APPROVAL FOR UPDATED MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY TESTING AND MRI CONDITIONS OF USE LABELING.
P910023|S257|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CURRENT/FORTIFY FAMILIES OF ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/2011|06/21/2011|||APPR|APPROVAL FOR SOFTWARE MODEL MN5000 V.5.0 FOR USE ON THE MERLIN.NET SYSTEM AND MODEL EX2000 V.5.0 FOR USE ON MERLIN@ HOME DEVICES.
P030054|S181|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/2011|06/21/2011|||APPR|APPROVAL FOR SOFTWARE MODEL MN5000 V.5.0 FOR USE ON THE MERLIN.NET SYSTEM AND MODEL EX2000 V.5.0 FOR USE ON MERLIN@ HOME DEVICES.
P970003|S124|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2011|04/19/2011|||APPR|REVISION TO THE TEST TAB ROUTING STEPS.
P080027|S005|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|135 Review Track For 30-Day Notice||N|03/16/2011|07/27/2011|||APPR|APPROVAL FOR THE OPTION TO AUTOMATE THE MANUFACTURING PROCESS FOR ASSEMBLY OF THE ORAQUICK® HCV RAPID ANTIBODY TEST.
P840001|S182|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SYNERGY/SYNERGY VERSITREL IPS/RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCE|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2011|05/06/2011|||APPR|ADDITION OF AN OPTIONAL DEBURRING PROCESS.
P970004|S109|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II INS|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2011|05/06/2011|||APPR|ADDITION OF AN OPTIONAL DEBURRING PROCESS.
P960009|S112|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|KINETRA/ACTIVA PC/ACTIVE SC/RC INS|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2011|05/06/2011|||APPR|ADDITION OF AN OPTIONAL DEBURRING PROCESS.
P080025|S001|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II INS|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2011|05/06/2011|||APPR|ADDITION OF AN OPTIONAL DEBURRING PROCESS.
P860004|S149|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PUMP|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2011|05/06/2011|||APPR|ADDITION OF AN OPTIONAL DEBURRING PROCESS.
P010030|S027|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2011|07/15/2011|||APPR|APPROVAL FOR THE MINOR HARDWARE (COMPONENTS) CHANGES DUE TO THE ROHS REQUIREMENTS FOR THE COMPONENTS OF THE DEVICES.
P080002|S001|THE FEMALE HEALTH CO.|515 NORTH STATE ST.|SUITE 2225|CHICAGO|IL|60610||Condom, female, single-use|FC2 FEMALE CONDOM|MBU|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2011|09/23/2011|||APPR|APPROVAL TO CHANGE THE SHELF LIFE OF THE FC2 FEMALE CONDOM FROM THREE YEARS TO FOUR YEARS.
P070022|S016|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2011|04/14/2011|||OK30|CHANGE IN INSPECTION PROCEDURE.
P070022|S017|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2011|04/08/2011|||OK30|IMPLEMENTATION OF A MICROBIOLOGY LABORATORY.
P010001|S009|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2011|04/19/2012|||APPR|APPROVAL FOR USE OF ADDITIONAL AND REPLACEMENT MACHINES FOR GRINDING, POLISHING AND DIMENSIONAL INSPECTION.
P970037|S005|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA HAFP KIT|LOK|IM|30-Day Notice||N|03/17/2011|04/08/2011|||OK30|CHANGE IN A RAW MATERIAL USED IN THE MANUFACTURE OF THE ENHANCEMENT SOLUTION AUXILIARY REAGENT USED WITH THE AUTODELFIA HAFP KIT.
P010013|S034|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2011|04/08/2011|||OK30|IMPLEMENTATION OF A MICROBIOLOGY LABORATORY.
P830061|S061|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/VITATRON CRYSTALINE & EXCELLENCE PS+|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|06/16/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY.
P850089|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/Z NOVUS/VITATRON EXCELLENCE SS+/IMPULSE II|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|06/16/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY.
P930039|S049|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|06/16/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY.
P010015|S111|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LEAD|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|06/16/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY.
P060039|S023|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|06/16/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY.
P090013|S010|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX MRI LEAD|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|06/16/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY.
P890003|S218|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD2 LEAD / BRILLIANT ST LEAD|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|06/16/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY.
P970020|S062|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ZETA CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|04/08/2011|||OK30|CHANGE IN EXTRUDED TUBING LENGTH, AND A CHANGE FROM A MANUAL TUBE CUTTING PROCESS TO AN AUTOMATED PROCESS.
P020047|S033|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION & MULTI-LINK MINI-VISION CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|04/08/2011|||OK30|CHANGE IN EXTRUDED TUBING LENGTH, AND A CHANGE FROM A MANUAL TUBE CUTTING PROCESS TO AN AUTOMATED PROCESS.
P070015|S061|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|04/08/2011|||OK30|CHANGE IN EXTRUDED TUBING LENGTH, AND A CHANGE FROM A MANUAL TUBE CUTTING PROCESS TO AN AUTOMATED PROCESS.
P910077|S111|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2011|05/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.
P840068|S048|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA PACEMAKER SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2011|05/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.
P940031|S070|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR PACEMAKER SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2011|05/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.
P960040|S242|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV ACID SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2011|05/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.
P010012|S265|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRACK CRT-D SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2011|05/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.
P030005|S073|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR CRT-P SYSTEM|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2011|05/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01.
P060022|S008|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRACULAR LENS|HQL|OP|135 Review Track For 30-Day Notice||N|03/18/2011|04/29/2011|||APPR|APPROVAL TO IMPLEMENT THE PROPOSED CHANGE TO THE BIOBURDEN TESTING FOR THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS.
P030052|S005|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|04/08/2011|||OK30|CHANGES TO THE REFERENCE DNA MANUFACTURING AND THE SMALL SCALE FERMENTATION PROCESSES.
P030054|S182|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Drug eluting permanent left ventricular (lv) pacemaker electrode|CRT LEADS (MODELS 1156T,  1158Y AND 1258T).|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2011|05/11/2011|||APPR|APPROVAL FOR A DIMENSIONAL CHANGE TO THE IS-1 CONNECTOR FRONT SEAL.
P060022|S009|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS ADAPT AO HOLDER FOLDER/M160 HOLDER/PARKER GASKET|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2011|10/07/2011|||OK30|TRANSFER OF BIOBURDEN TESTING OF THE AKREOS ADAPT AO HOLDER FOLDER, M160 HOLDER, AND PARKER GASKET FROM A CONTRACT VENDOR TO BAUSCH & LOMB.
P070015|S062|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2011|04/08/2011|||OK30|REMOVE REDUNDANT CLEANING AND TREATMENT STEPS.
P060012|S007|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2011|04/21/2011|||APPR|APPROVAL FOR A CHANGE OF TEST METHOD WITH A DIFFERENT ASSAY FOR DETERMINING ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN SPECIFIC ACTIVITY AND ALLOWING FOR USE OF HIGH TITER IGG IN IN PLACE OF EACH OTHER WHEN THEIR CONCENTRATIONS OVERLAP.
P060003|S009|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM AUSAB|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2011|05/13/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE QUALITY CONTROL TEST METHODS.
P830037|S052|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FRESHLOOK (PHEMFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2011|04/21/2011|||OK30|UPGRADING THE CONTROL SYSTEM IN THE FINN AQUA STERILIZER FA5.
P000008|S022|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/18/2011|11/18/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000008|S023|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/18/2011|08/15/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020014|S033|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM|HHS|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/22/2011|02/22/2012|||APPR|APPROVAL FOR AN ALTERNATE HYDROPHILIC COATING OF THE DELIVERY CATHETER.
P060022|S010|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/16/2011|10/21/2011|||APPR|APPROVAL FOR THE REMOVAL OF VERBIAGE PERTAINING TO THE CLINICAL ASSESSMENT OF THE ADDITION OF THE ASPHERIC SURFACE.
P030054|S183|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FAMILY OF CRT-DS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|05/10/2011|||APPR|APPROVAL FOR TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS.
P910023|S258|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FAMILY OF ICDS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|05/10/2011|||APPR|APPROVAL FOR TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS.
P880086|S199|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|FAMILY OF CRT-PS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|05/10/2011|||APPR|APPROVAL FOR TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS.
P030035|S079|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FAMILY OF PACEMAKERS|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|05/10/2011|||APPR|APPROVAL FOR TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS.
P070005|S002|PATHFINDER CELL THERAPY INC.|12 BOW STREET||CAMBRIDGE|MA|02138||Barrier, adhesion, cardiovascular|REPEL-CV|OBD|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/07/2011|05/05/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980035|S211|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SIGMA IPG FAMILY/MEDTRONIC 350/ENRHYTHM/AT500 SYSTEMS/ADAPTA/VERSA/SENSIA/RELIA IPGS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P830061|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS/CAPSURE/CAPSURE SENSE LEADS/VITATRON EXCELLENCE PS+/VITATRON CRYSTALLINE|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P850089|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z/SP NOVUS LEADS/CAPSURE/VIATRON EXCELLENCE/SS+/VITATRON IMPULSE II CAPSURE SP Z LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P890003|S219|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG/LEADS WRENCH KIT/LEADS SERVICE KIT/VITATRON BRILLIANT S+/CAPSURE VDD LEADS/CONNECTOR PORT PIN-PLUG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P900061|S100|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER/PATCH LEAD/LEAD END PIN CAP|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P920015|S074|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IS-1 PORT PIN PLUG/Y ADAPTOR KIT/LEAD ADAPTOR/SPRINT LEAD/QUATTRO/QUATTRO SECURE/SUBCUTANEOUS DEFIBRILLATION/TRANSVENE|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P930039|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS/SUREFIX/CAPSUREFIX/VITATRON PIROUET/VITATRON CRYSTALLINE ACTFIX LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P950024|S029|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR/BIPOLAR LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P980016|S288|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO ICD/INTRINSIC ICD/CAPSURE LEAD/ENTRUST ICD/VIRTUOSO ICD/MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P980050|S059|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CS-SVC TRANSVENE LEAD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P990001|S086|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|C & T SERIES IPG|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P010015|S112|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III CRT-P/ATTAIN OTW LEAD/BIPOLAR OTW/LV LEADS|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P010031|S242|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC II/III MARQUIS/MARQUIS ICD/SENTRY ICD FAMILY/MAXIMO ICD FAMILY/CONCERTO CRT-D/MAXIMO II CRT-D/CONSULTA CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P030036|S027|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD/SLEEVE KIT|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P060039|S024|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P080006|S021|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P090013|S011|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO IPG & REVO MRI LEAD|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2011|06/27/2011|||APPR|APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
P080013|S006|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/21/2011|05/20/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL
P050023|S044|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2011|05/06/2011|||OK30|ADDITION OF AN INSPECTION STEP DURING THE BATTERY MANUFACTURING PROCESS.
P950037|S095|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2011|05/06/2011|||OK30|ADDITION OF AN INSPECTION STEP DURING THE BATTERY MANUFACTURING PROCESS.
P000053|S036|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2011|06/13/2011|||APPR|APPROVAL FOR A NEW COMPONENT MOLD.
P920047|S046|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II & BLAZER PRIME HTD CATHETERS|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2011|07/27/2011|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION CYCLE.
P020025|S027|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP & BLAZER PRIME XP CATHETERS|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2011|07/27/2011|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION CYCLE.
P980003|S028|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II CATHETERS|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2011|07/27/2011|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION CYCLE.
N17679|S035|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|TETRAFILCON A|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2011|04/29/2011|||OK30|CHANGES IN CRITERIA FOR ACCEPTANCE FOR WATER CONTENT FROM 5% TO 2%; AND REVISION TO MAXIMUM SPECIFICATIONS OF LENS MATERIAL COMPONENTS AND THE SPECIFICATION FOR WATER CONTENT.
P010021|S019|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2011|08/02/2011|||APPR|APPROVAL FOR THE REPLACEMENT OF A RAW MATERIAL, FOETAL CALF SERUM, WITH BOVINE SERUM ALBUMIN IN THE FORMULATION OF THE VITROS ANTI-HCV CONJUGATE REAGENT.
P040027|S024|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2011|11/10/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN PHOENIX, ARIZONA.
P010019|S022|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CIBA VISION LOTRAFILCON B SOFT CONTACT LENSES FOR EXTEND WEAR|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2011|05/18/2011|||APPR|APPROVAL TO CHANGE THE PLASMA COATING PARAMETERS
P020045|S037|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CARDIAC ABLATION PERCUTANEOUS CATHETER|LPB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2011|07/15/2011|||APPR|APPROVAL FOR STERILIZATION AND PACKAGING CHANGES.
P100010|S008|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2011|07/15/2011|||APPR|APPROVAL FOR STERILIZATION AND PACKAGING CHANGES.
P070015|S063|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2011|04/08/2011|||OK30|MODIFICATION OF CLEANROOM CLASSIFICATION AND GOWNING REQUIREMENTS.
P070015|S064|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2011|08/23/2011|||APPR|APPROVAL FOR THE TRANSFER OF SEVERAL EVEROLIMUS DRUG TESTS FROM A THIRD PARTY LAB TO THE ABBOTT VASCULAR TECHNICAL SERVICE LAB IN TEMECULA, CALIFORNIA.
P910073|S094|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|RELIANCE 4-SITE LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2011|09/01/2011|||APPR|APPROVAL FOR DESIGN CHANGES TO THE TERMINAL TOOL (RENAMED EZ-4 CONNECTOR TOOL), DESIGN CHANGE TO THE LEAD AND TOOL PACKAGING, AND VARIOUS LABELING CHANGES.
P830060|S067|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2011|09/01/2011|||APPR|APPROVAL FOR DESIGN CHANGES TO THE TERMINAL TOOL (RENAMED EZ-4 CONNECTOR TOOL), DESIGN CHANGE TO THE LEAD AND TOOL PACKAGING, AND VARIOUS LABELING CHANGES.
P090013|S012|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN PACING SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2011|05/27/2011|||APPR|APPROVAL FOR SOFTWARE APPLICATION SW005 VERSION 7.3 FOR CARELINK MODEL 2090 PROGRAMMER.
P890003|S220|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR 2490G|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2011|05/27/2011|||APPR|APPROVAL FOR MODEL 2490G (VERSION 9V5) MEDTRONIC CARELINK MONITOR AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (REVO MRI SW018 XMLTU AND ENRHYTHM MRI V7.3 SW005 XMLTU).
P030050|S010|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA (INJECTABLE POLY-L-LACTIC ACID) & SCULPTRA AESTHETIC (INJECTABLE POLY -L-LACTIC ACID)|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2011|06/14/2011|||OK30|CHANGE THE LOCATION OF THE DESIGN CONTROL CENTER FOR SCULPTRA AND SCULPTRA AETHETIC FROM SANOFI AVENTIS U.S. LLC TO ANAGNI ITALY.
P070015|S065|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2011|04/29/2011|||OK30|EXTENSION OF SHELF LIFE AND RETEST DATE OF AN INTERMEDIATE COMPONENT.
P050018|S013|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER, EASY EXCHANGE (EX0|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2011|04/08/2011|||OK30|ADDITION OF AN INFLATION LUMEN INSPECTION.
P090013|S013|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN PACING SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2011|05/27/2011|||APPR|APPROVAL FOR MODEL 2490G (VERSION 9V5) MEDTRONIC CARELINK MONITOR AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (REVO MRI SW018 XMLTU AND ENRHYTHM MRI V7.3 SW005 XMLTU).
P020045|S038|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2011|04/29/2011|||OK30|TRANSFER THE GAS FILLING AND TESTING OPERATIONS FOR THE COMPRESSOR SUBASSEMBLY TO THE SUPPLIER.
P100010|S009|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|BALLOON CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2011|04/29/2011|||OK30|TRANSFER THE GAS FILLING AND TESTING OPERATIONS FOR THE COMPRESSOR SUBASSEMBLY TO THE SUPPLIER.
P960009|S113|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2011|04/29/2011|||OK30|IMPLEMENTATION OF MANUFACTURING CHANGES FOR ACTIVA DEVICES.
P070015|S066|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2011|04/29/2011|||OK30|MODIFICATION OF A SAMPLING PLAN FOR PARTICULATE TESTING.
P050037|S028|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2011|06/20/2012|||APPR|APPROVAL FOR THE ADDITION OF SAFETY AND EFFECTIVENESS CLINICAL DATA AND POST-MARKETING SURVEILLANCE DATA FROM THE POST APPROVAL STUDIES PERFORMED AS A CONDITION OF APPROVAL FOR THE RADIESSE INJECTABLE IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME RADIESSE INJECTABLE IMPLANT AND IS INDICATED FOR SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS AND IT IS ALSO INTENDED FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.
P050052|S031|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2011|06/20/2012|||APPR|APPROVAL FOR THE ADDITION OF SAFETY AND EFFECTIVENESS CLINICAL DATA AND POST-MARKETING SURVEILLANCE DATA FROM THE POST APPROVAL STUDIES PERFORMED AS A CONDITION OF APPROVAL FOR THE RADIESSE INJECTABLE IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME RADIESSE INJECTABLE IMPLANT AND IS INDICATED FOR SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS AND IT IS ALSO INTENDED FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.
P990013|S031|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2011|05/04/2011|||OK30|MODIFICATION TO THE BLOCKING PROCESS FOR THE MANUFACTURE OF THE PRODUCT LINES.
P030016|S020|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA|MTA|OP|30-Day Notice||N|03/30/2011|05/04/2011|||OK30|MODIFICATION TO THE BLOCKING PROCESS FOR THE MANUFACTURE OF THE PRODUCT LINES.
P910065|S008|TOSOH BIOSCIENCE, INC.|6000 SHORELINE COURT|SUITE 101|SOUTH SAN FRANCISCO|CA|94080||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMMUNOASAY, PSA|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/2011|02/13/2012|||APPR|APPROVAL FOR THE ADDITION OF ONE FDA-CLEARED TOSOH AUTOMATED IMMUNOASSAY ANALYZER, THE AIA-900, FOR USE WITH THE ST AIA-PACK PA ASSAY.
P910077|S112|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE COMMUNICATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2011|04/29/2011|||OK30|REWORK OF PRINTED CIRCUIT ASSEMBLIES (PCAS) USED IN THE MANUFACTURE OF THE LATITUDE¿ COMMUNICATOR.
P970003|S125|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY DEMIPULSE/DEMIPULSE DUO GENERATORS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2011|04/29/2011|||OK30|MODIFICATION OF VISUAL INSPECTION ACCEPTANCE CRITERIA FOR THREE CAPACITORS
P060031|S005|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2011|04/28/2011|||OK30|CHANGE IN THE SCALE OF MANUFACTURE OF THE CONJUGATE REAGENT COMPONENT OF THE BIO-RAD MONOLISA ANTI-HBC EIA.
P050047|S016|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|03/29/2012|||APPR|APPROVAL FOR THE PROPOSED CHANGE IN THE INTERMEDIATE HA CONCENTRATION DURING PRODUCT MANUFACTURE.
P910073|S095|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|MAKE BSC THE PRIMARY SUPPLIER OF THE 4-SITE LEAD TERMINAL ASSEMBLY.
P050019|S007|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|BOSTON SCIENTIFIC CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (CAROTID WALLSTENT ENDOPROSTHESIS)|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|05/02/2011|||OK30|SEVERAL EQUIPMENT UPGRADES, A CHANGE TO THE PHYSICAL LINE LAYOUT, AND INTRODUCTION OF AUTOMATED PROCESS SETTINGS.
P900056|S104|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/2011|08/31/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE ROTAWIRE AND ROTALINK BURR/ ROTALINK PLUS INSTRUCTIONS FOR USE (IFU).
P020009|S073|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS & EXPRESS 2 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|05/04/2011|||OK30|AUTOMATION OF THE PACKAGING AND VERIFICATION PROCESS.
P040016|S071|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|05/04/2011|||OK30|AUTOMATION OF THE PACKAGING AND VERIFICATION PROCESS.
P060006|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|05/04/2011|||OK30|AUTOMATION OF THE PACKAGING AND VERIFICATION PROCESS.
P060008|S069|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|05/04/2011|||OK30|AUTOMATION OF THE PACKAGING AND VERIFICATION PROCESS.
P030005|S074|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR FAMILY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P830060|S068|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK/VENTAK P/VENTAK P2 FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P890061|S019|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK/VENTAK P/VENTAK P2 FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P930035|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK/VENTAK P/VENTAK P2 FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P840068|S049|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA/VISTA FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P940031|S071|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR/DISCOVERY/MERIDIAN FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P050046|S010|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P010012|S266|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD/EASYTRAK/LIVIAN/COGNIS/ACUITY SPIRAL FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P950001|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE LEAD FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P910077|S113|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX/MINI FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P960040|S243|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/VENTAK PRIZM DR/VR/VITALITY/CONFIENT/LIVIAN FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P910073|S096|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P940008|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q/RES-Q MICRON FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P960006|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND FAMILIES|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P960004|S049|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE/FINELINE FAMILIES|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2011|04/29/2011|||OK30|CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
P970008|S056|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|04/29/2011|||OK30|CHANGES IN THE QUALITY CONTROL TESTING.
P060007|S012|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|04/21/2011|||OK30|TEST METHOD CONVERSIONS, RAW MATERIAL AND VENDOR CHANGES.
P070015|S067|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|04/04/2011|05/04/2011|||OK30|CHANGE TO ANNUAL CERTIFICATION TESTING FOR AN APPROVED SUPPLIER.
P960030|S033|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|ISOFLEX MODEL 1646T & MODEL 1948T (OPTIM) LOW VOLTAGE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/05/2011|||OK30|ALTERNATE SUPPLIER FOR THE INNER AND OUTER COILS USED TO MANUFACTURE LOW VOLTAGE LEADS.
P030008|S006|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/2011|11/23/2011|||APPR|APPROVAL FOR INCREASED PULSE FREQUENCY FROM 400 TO 500 HZ, A NEW LASER HEAD, A NEW HOUSING WITH GREATER INTEGRATION OF ACCESSORIES, MODIFIED LASER PULSE TEMPORAL PARAMETERS, NEW EYETRACKER, NEW SCANNER, REMODELED USER INTERFACE, ADDITION OF NETWORKING CAPABILITY, ANDMODIFIED SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME WAVELIGHT EX500 LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR:1) THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO -12.0 DIOPTERS (D) OF SPHERE AND UP TO - 6.0 D OF ASTIGMATISM AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D OF PREOPERATIVESPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY;2) THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 D OF SPHERE WITH AND WITHOUT ASTIGMATIC REFRACTIVE ERRORS UP TO 5.0 D AT THE SPECTACLE PLANE, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION DEFINED AS<= 0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY, EXCLUSIVE OF CHANGES DUE TO UNMASKING LATENT HYPEROPIA;3) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 D AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS  <= 0.50 D PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 4) THE WAVEFRONT-GUIDED (WFG) REDUCTION OR ELIMINATION OF UP TO -7.00 D OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 D OF SPHERICAL COMPONENT AND UP TO 3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D OF PREOPERATIVE SPHERICAL SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P020050|S006|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/2011|11/23/2011|||APPR|APPROVAL FOR INCREASED PULSE FREQUENCY FROM 400 TO 500 HZ, A NEW LASER HEAD, A NEW HOUSING WITH GREATER INTEGRATION OF ACCESSORIES, MODIFIED LASER PULSE TEMPORAL PARAMETERS, NEW EYETRACKER, NEW SCANNER, REMODELED USER INTERFACE, ADDITION OF NETWORKING CAPABILITY, ANDMODIFIED SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME WAVELIGHT EX500 LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR:1) THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO -12.0 DIOPTERS (D) OF SPHERE AND UP TO - 6.0 D OF ASTIGMATISM AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D OF PREOPERATIVESPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY;2) THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 D OF SPHERE WITH AND WITHOUT ASTIGMATIC REFRACTIVE ERRORS UP TO 5.0 D AT THE SPECTACLE PLANE, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION DEFINED AS<= 0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY, EXCLUSIVE OF CHANGES DUE TO UNMASKING LATENT HYPEROPIA;3) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 D AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS  <= 0.50 D PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 4) THE WAVEFRONT-GUIDED (WFG) REDUCTION OR ELIMINATION OF UP TO -7.00 D OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 D OF SPHERICAL COMPONENT AND UP TO 3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D OF PREOPERATIVE SPHERICAL SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P840001|S183|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/ITREL 3/SYNERGY/SYNERGY VERSITREL INS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/04/2011|||OK30|IMPLEMENTATION OF NEWLY VALIDATED PROCESS PARAMETERS FOR THE BLISTER SEALING MACHINE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) LOCATED IN JUNCOS, PUERTO RICO.
P960009|S114|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA/KINETRA/ACTIVA PC/SC/RC INS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/04/2011|||OK30|IMPLEMENTATION OF NEWLY VALIDATED PROCESS PARAMETERS FOR THE BLISTER SEALING MACHINE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) LOCATED IN JUNCOS, PUERTO RICO.
P970004|S110|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/04/2011|||OK30|IMPLEMENTATION OF NEWLY VALIDATED PROCESS PARAMETERS FOR THE BLISTER SEALING MACHINE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) LOCATED IN JUNCOS, PUERTO RICO.
P080025|S002|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/04/2011|||OK30|IMPLEMENTATION OF NEWLY VALIDATED PROCESS PARAMETERS FOR THE BLISTER SEALING MACHINE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) LOCATED IN JUNCOS, PUERTO RICO.
P090013|S015|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/05/2011|||OK30|THE SUBJECT DEVICES ARE ABLE TO BE MANUFACTURED USING NEW PLATING LINES AT THE QUALIFIED SUPPLIER.
P980016|S289|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/XT DR/XT VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/05/2011|||OK30|THE SUBJECT DEVICES ARE ABLE TO BE MANUFACTURED USING NEW PLATING LINES AT THE QUALIFIED SUPPLIER.
P980035|S213|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/05/2011|||OK30|THE SUBJECT DEVICES ARE ABLE TO BE MANUFACTURED USING NEW PLATING LINES AT THE QUALIFIED SUPPLIER.
P010031|S243|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA CRT-D/PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/05/2011|||OK30|THE SUBJECT DEVICES ARE ABLE TO BE MANUFACTURED USING NEW PLATING LINES AT THE QUALIFIED SUPPLIER.
P010015|S113|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|SYNCRA CRT-P/CONSULTA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2011|05/05/2011|||OK30|THE SUBJECT DEVICES ARE ABLE TO BE MANUFACTURED USING NEW PLATING LINES AT THE QUALIFIED SUPPLIER.
P100040|S001|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/02/2011|||OK30|ADDITION OF LUBRICANT TO A MANUFACTURING PROCESS.
P910023|S260|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/05/2011|||OK30|ADDITION OF A SECONDARY SUPPLIER FOR ORGANIC SUBSTRATES.
P030054|S185|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/05/2011|||OK30|ADDITION OF A SECONDARY SUPPLIER FOR ORGANIC SUBSTRATES.
P050017|S006|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM|NIO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/04/2011|07/05/2011|||APPR|APPROVAL FOR A PRODUCT LINE EXTENSION THAT REPRESENTS MODIFICATIONS TO THE 6FR VERSION OF THE ZILVER VASCULAR STENT. IN ADDITION, APPROVAL  OF MINOR CHANGES TO THE STENT AND DELIVERY SYSTEM AND THE ADDITION OF A 100 MM LENGTH STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZILVER FLEX 35 VASCULAR STENT AND IS INDICATED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.  PATIENTS MUST BE SUITABLE FOR PTA AND STENT TREATMENT.
P010015|S114|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA/SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/05/2011|||OK30|MOVING STERILIZATION EQUIPMENT WITHIN A FACILITY AND IMPLEMENTATION OF A BAR CODE READER SYSTEM.
P010031|S244|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA/PROTECTA XT CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/05/2011|||OK30|MOVING STERILIZATION EQUIPMENT WITHIN A FACILITY AND IMPLEMENTATION OF A BAR CODE READER SYSTEM.
P980016|S290|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/XT DR/XT VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/05/2011|||OK30|MOVING STERILIZATION EQUIPMENT WITHIN A FACILITY AND IMPLEMENTATION OF A BAR CODE READER SYSTEM.
P980035|S214|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/05/2011|||OK30|MOVING STERILIZATION EQUIPMENT WITHIN A FACILITY AND IMPLEMENTATION OF A BAR CODE READER SYSTEM.
P030054|S186|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/03/2011|||OK30|ALTERNATE PLATING SUPPLIER.
P030035|S081|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FAMILY OF PACEMAKERS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/03/2011|||OK30|ALTERNATE PLATING SUPPLIER.
P880086|S201|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|FAMILY OF CRT-PS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/03/2011|||OK30|ALTERNATE PLATING SUPPLIER.
P910023|S261|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2011|05/03/2011|||OK30|ALTERNATE PLATING SUPPLIER.
P990009|S032|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2011|05/10/2011|||OK30|CHANGE IN AN IN-PROCESS TEST METHOD FOR THE DEVICE.
P030005|S075|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2011|05/05/2011|||OK30|REVISE THE ELECTRICAL TEST SOFTWARE.
P070006|S005|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT TB TEST|OJN|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2011|05/04/2011|||OK30|ADDITION OF A SECOND APPROVED SUPPLIER OF ANTIBODY COATED PLATES FOR THE DEVICE.
P080027|S006|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2011|05/04/2011|||OK30|AUTOMATE THE VIAL FILLING AND CAPPING PROCESS FOR THE DEVELOPER SOLUTION VIALS, A COMPONENT IN THE DEVICE.
P980018|S013|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/06/2011|04/18/2011|||APPR|APPROVAL FOR LABELING CHANGES THAT ADD PRECAUTION AND AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF HERCEPTEST.
P010031|S245|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA XT/PROTECTA DEVICES||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2011|05/05/2011|||OK30|MULTIPLE MANUFACTURING CHANGES TO THE ASSEMBLY LINE, EQUIPMENT IMPROVEMENT AND PARAMETERS, PROCESS MONITORING, AND LABORATORY ANALYSIS.
P980016|S291|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/XT DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2011|05/05/2011|||OK30|MULTIPLE MANUFACTURING CHANGES TO THE ASSEMBLY LINE, EQUIPMENT IMPROVEMENT AND PARAMETERS, PROCESS MONITORING, AND LABORATORY ANALYSIS.
P060030|S018|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/2011|05/05/2011|||APPR|APPROVAL FOR AN ADDITION TO THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V1.0 PACKAGE INSERT.
P080006|S022|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY PLUS MODEL 4296|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2011|05/05/2011|||OK30|CHANGE IN AERATION CYCLE TIME.
P970051|S069|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2011|06/03/2011|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE EXTERNAL CP810 SOUND PROCESSOR MAIN BTE MODULE (APPROVED UNDER P970051/S049), CALLED BUILD STANDARD D, WHICH IS PRIMARILY INTENDED TO ALLOW FOR REPAIR OF THE PROCESSOR.
P030026|S021|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice||N|12/08/2010|04/22/2011|||OK30|A CHANGE IN THE MANUFACTURING SCALE OF A REAGENT COMPONENT.
P790005|S047|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/08/2011|05/06/2011|||APPR|APPROVAL FOR MANUFACTURING CHANGES INVOLVING THE VERIFICATION OF ALCOHOL STERILITY AND THE MAGNET OVERRIDING TEST FIXTURE.
P970021|S035|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2011|05/05/2011|||OK30|CHANGE IN RAW MATERIAL AND SUPPLIER.
P050012|S037|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/08/2011|06/03/2011|||APPR|APPROVAL FOR REPLACEMENT OF AN OBSOLETE LCD IN THE RECEIVER ASSEMBLY WITH A SIMILAR COMPONENT AND MINOR MODIFICATIONS TO THE RECEIVER FIRMWARE TO ACCOMMODATE THE NEW HARDWARE.
P970004|S111|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|3058 INTERSTIM II INS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2011|05/06/2011|||OK30|CHANGE IN THE TESTING EQUIPMENT AND TEST SPECIFICATIONS.
P080025|S003|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|3058 INTERSTIM II INS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2011|05/06/2011|||OK30|CHANGE IN THE TESTING EQUIPMENT AND TEST SPECIFICATIONS.
P860057|S078|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL/RSR/MAGNA/MAGNA EASE/MITRAL/MAGNA MITRAL AORTIC PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2011|05/05/2011|||OK30|ADDITION OF A THIRD- PARTY SUPPLIER OF THE MOLDED SILICONE INSERTS USED IN THE DEVICES.
P870056|S043|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC/PORCINE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2011|05/05/2011|||OK30|ADDITION OF A THIRD- PARTY SUPPLIER OF THE MOLDED SILICONE INSERTS USED IN THE DEVICES.
P870077|S039|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2011|05/05/2011|||OK30|ADDITION OF A THIRD- PARTY SUPPLIER OF THE MOLDED SILICONE INSERTS USED IN THE DEVICES.
P010041|S027|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2011|05/05/2011|||OK30|ADDITION OF A THIRD- PARTY SUPPLIER OF THE MOLDED SILICONE INSERTS USED IN THE DEVICES.
P070015|S068|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/12/2011|||OK30|CHANGES TO THE TEST METHOD FOR THE IDENTIFICATION AND ASSAY OF ANTIOXIDANT IN THE ACCEPTANCE AND STABILITY TESTING OF THE EVEROLIMUS DRUG SUBSTANCE.
P070026|S001|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/08/2011|06/07/2011|||APPR|APPROVAL OF POST-APPROVAL STUDY PROTOCOL.
P990056|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|135 Review Track For 30-Day Notice|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|06/20/2011|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING SITE FROM BUILDINGS 341, 345 AND 651 TO BUILDING 761, ALL WITHIN THE ROCHE PENZBERG, GERMANY FACILITY.
P000027|S009|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA IMMUNOASSAY|MTG|IM|135 Review Track For 30-Day Notice|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|06/20/2011|||APPR|APPROVAL FOR A CHANGE IN THE MANUFACTURING SITE FROM BUILDINGS 341, 345 AND 651 TO BUILDING 761, ALL WITHIN THE ROCHE PENZBERG, GERMANY FACILITY.
P910023|S262|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST JUDE MEDICAL ICDS & CRT-DS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/11/2011|||OK30|CHANGE IN THE MEMS SENSOR MOUNTING MATERIAL.
P030054|S187|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST JUDE MEDICAL ICDS & CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/11/2011|||OK30|CHANGE IN THE MEMS SENSOR MOUNTING MATERIAL.
P030009|S054|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/2011|06/09/2011|||APPR|APPROVAL FOR ADDITION OF LABELING REGARDING SIMULTANEOUS USE OF THE INTEGRITY RX STENT SYSTEM WITH EITHER ANOTHER INTEGRITY RX STENT SYSTEM, OR WITH A SPRINTER LEGEND RX BALLOON DILATION CATHETER.  IN ADDITION, APPROVAL TO REVISE THE MRI COMPATIBILITY INFORMATION IN THE LABELING.
P950037|S096|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2011|05/26/2011|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.
P010015|S115|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA/SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/05/2011|||OK30|CHANGE TO AN EPOXY DISPENSER PARAMETER, THE IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER, AND AN UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P010031|S246|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA/PROTECTA XT CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/05/2011|||OK30|CHANGE TO AN EPOXY DISPENSER PARAMETER, THE IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER, AND AN UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P980016|S292|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/XT DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/05/2011|||OK30|CHANGE TO AN EPOXY DISPENSER PARAMETER, THE IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER, AND AN UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P980035|S215|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/05/2011|||OK30|CHANGE TO AN EPOXY DISPENSER PARAMETER, THE IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER, AND AN UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P990012|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/04/2011|||OK30|CHANGE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT COMMON TO ALL DEVICES.
P010054|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/04/2011|||OK30|CHANGE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT COMMON TO ALL DEVICES.
P090007|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/04/2011|||OK30|CHANGE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT COMMON TO ALL DEVICES.
P090009|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/04/2011|||OK30|CHANGE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT COMMON TO ALL DEVICES.
P090008|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2011|05/04/2011|||OK30|CHANGE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT COMMON TO ALL DEVICES.
P000009|S045|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2011|05/26/2011|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.
P050023|S045|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2011|05/26/2011|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.
P070008|S023|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2011|05/26/2011|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.
P980023|S044|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2011|05/26/2011|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.
P050033|S012|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2011|09/02/2011|||APPR|APPROVAL FOR PROPOSED MANUFACTURE OF SMALL SCALE BATCHES.
P920015|S075|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE SVC LEAD MODEL 6937/SUBCUTANEOUS LEAD MODEL 6996SQ & VARIOUS ACCESSORIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2011|05/12/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING A PROCESS RECIPE CHANGE, NEW TRAY CONFIGURATIONS, AND THE ADDITION OF A MONITORING TEST.
P020014|S034|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|||N|04/12/2011|07/01/2011|||APPR|APPROVAL TO REMOVE A CONTRAINDICATION AND TO REVISE A WARNING REGARDING NICKEL SENSITIVITY IN PHYSICIANS LABELING.
P980050|S060|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2011|05/12/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING A PROCESS RECIPE CHANGE, NEW TRAY CONFIGURATIONS, AND THE ADDITION OF A MONITORING TEST.
P950024|S030|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI UNIPOLAR/BIPOLAR LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2011|05/12/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING A PROCESS RECIPE CHANGE, NEW TRAY CONFIGURATIONS, AND THE ADDITION OF A MONITORING TEST.
P030036|S028|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2011|05/12/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING A PROCESS RECIPE CHANGE, NEW TRAY CONFIGURATIONS, AND THE ADDITION OF A MONITORING TEST.
P900061|S101|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE EPICARDIAL LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2011|05/12/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING A PROCESS RECIPE CHANGE, NEW TRAY CONFIGURATIONS, AND THE ADDITION OF A MONITORING TEST.
P070022|S018|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANMENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/10/2011|||OK30|THE MOVE OF MANUFACTURING LINES.
P010013|S035|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/10/2011|||OK30|RELOCATION OF A CABLE ASSEMBLY PROCESS.
P070015|S069|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/12/2011|||OK30|A MANUAL TO AN AUTOMATED PROCESS CHANGE FOR PACKAGING LABELING INSPECTION.
P050018|S014|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/12/2011|||OK30|MANUFACTURING CHANGE TO INCLUDE A NEW PART NUMBER FOR THE DEVICE AND THE PURCHASE OF THE OEM RAPID EXCHANGE BALLOON CATHETER MANUFACTURED BY A QUALIFIED SUPPLIER.
P010019|S023|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A & LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/11/2011|||OK30|RAW MATERIAL TEST METHOD CHANGE.
P010031|S247|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA/PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/13/2011|||OK30|MULTIPLE CHANGES INCLUDING A COMPONENT SUPPLIER AND INSPECTION CHANGE, CHANGES TO AN IN-PROCESS DEVICE TESTER, AND A CHANGE TO AN INSPECTION TEST METHOD.
P070022|S019|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/27/2011|||APPR|APPROVAL OF A BACKUP STERILIZATION FACILITY LOCATED AT BIOTEST LABORATORIES, INC., IN BROOKLYN PARK, MINNESOTA.
P010015|S116|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA/SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/13/2011|||OK30|MULTIPLE CHANGES INCLUDING A COMPONENT SUPPLIER AND INSPECTION CHANGE, CHANGES TO AN IN-PROCESS DEVICE TESTER, AND A CHANGE TO AN INSPECTION TEST METHOD.
P980016|S293|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/XT DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/13/2011|||OK30|MULTIPLE CHANGES INCLUDING A COMPONENT SUPPLIER AND INSPECTION CHANGE, CHANGES TO AN IN-PROCESS DEVICE TESTER, AND A CHANGE TO AN INSPECTION TEST METHOD.
P020014|S035|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/2011|03/19/2012|||APPR|APPROVAL FOR REVISED PROFESSIONAL AND PATIENT LABELING.
P030024|S015|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2011|05/11/2011|||OK30|MANUFACTURING CHANGES BEING MADE TO THE DEVICE.
P060023|S002|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|BRYAN CERVICAL DISC|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2011|09/13/2012|||APPR|APPROVAL FOR A CHANGE TO THE INJECTION MOLDING PROCESS.
P060033|S065|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2011|05/12/2011|||OK30|REDUCTION IN PYROGEN TESTING SAMPLE SIZE.
P030009|S055|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2011|05/12/2011|||OK30|REDUCTION IN PYROGEN TESTING SAMPLE SIZE.
P010015|S117|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA & SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2011|05/13/2011|||OK30|MULTIPLE MANUFACTURING CHANGES INCLUDING A COMPONENT TEST METHOD UPDATE, IMPLEMENTATION OF A NEW COMPONENT CLEANING PROCESS, AND IMPLEMENTATION OF ADDITIONAL LABELING EQUIPMENT AND SOFTWARE.
P010031|S248|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA & PROTECTA XT CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2011|05/13/2011|||OK30|MULTIPLE MANUFACTURING CHANGES INCLUDING A COMPONENT TEST METHOD UPDATE, IMPLEMENTATION OF A NEW COMPONENT CLEANING PROCESS, AND IMPLEMENTATION OF ADDITIONAL LABELING EQUIPMENT AND SOFTWARE.
P980016|S294|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/XT DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2011|05/13/2011|||OK30|MULTIPLE MANUFACTURING CHANGES INCLUDING A COMPONENT TEST METHOD UPDATE, IMPLEMENTATION OF A NEW COMPONENT CLEANING PROCESS, AND IMPLEMENTATION OF ADDITIONAL LABELING EQUIPMENT AND SOFTWARE.
P980035|S216|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2011|05/13/2011|||OK30|MULTIPLE MANUFACTURING CHANGES INCLUDING A COMPONENT TEST METHOD UPDATE, IMPLEMENTATION OF A NEW COMPONENT CLEANING PROCESS, AND IMPLEMENTATION OF ADDITIONAL LABELING EQUIPMENT AND SOFTWARE.
P910007|S028|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|05/11/2011|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD AND ADDITION OF AN ALTERNATE MANUFACTURING MATERIAL (POLYPROPYLENE RESIN) AND AN ALTERNATE VENDOR.
P980007|S019|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|05/11/2011|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD AND ADDITION OF AN ALTERNATE MANUFACTURING MATERIAL (POLYPROPYLENE RESIN) AND AN ALTERNATE VENDOR.
P050042|S011|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|05/13/2011|||OK30|CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.
P050051|S011|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|05/13/2011|||OK30|CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.
P080023|S007|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|05/13/2011|||OK30|CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORYCOMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIALCOMMON TO ALL DEVICES.
P060035|S007|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|05/13/2011|||OK30|CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.
P060007|S013|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|05/13/2011|||OK30|CHANGE TO ADD A QUALITY CONTROL TEST METHOD FOR A COMPONENT ACCESSORY COMMON TO ALL DEVICES, AND A CHANGE TO ADD AN ALTERNATE SUPPLIER OF A MANUFACTURING MATERIAL COMMON TO ALL DEVICES.
P840001|S184|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RETSOREADVANCED/EXTERNAL NEUROSTIMULAR INS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|11/09/2011|||APPR|APPROVAL FOR A MODIFICATION TO A CLEANING PROCESS FOR HYBRID COMPONENTS.
P970004|S112|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II INS|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|11/09/2011|||APPR|APPROVAL FOR A MODIFICATION TO A CLEANING PROCESS FOR HYBRID COMPONENTS.
P070015|S070|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|09/07/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT NUTRITION IN SLIGO, IRELAND.
P860004|S150|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PUMP|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|11/09/2011|||APPR|APPROVAL FOR A MODIFICATION TO A CLEANING PROCESS FOR HYBRID COMPONENTS.
P080025|S004|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II INS|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|11/09/2011|||APPR|APPROVAL FOR A MODIFICATION TO A CLEANING PROCESS FOR HYBRID COMPONENTS.
P960009|S115|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC/RC INS & EXTERNAL NEUROSTIMULATOR|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2011|11/09/2011|||APPR|APPROVAL FOR A MODIFICATION TO A CLEANING PROCESS FOR HYBRID COMPONENTS.
P880047|S015|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|ABSORBABLE ADHESION BARRIER|MCN|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2011|06/17/2011|||APPR|APPROVAL FOR A LARGER INTERCEED PRODUCT THAT MEASURES 5¿X6¿ IN SIZE.  THE DEVICE, AS MODIFIED, IS INDICATED AS AN ADJUVANT IN OPEN (LAPAROTOMY) GYNECOLOGIC PELVIC SURGERY FOR REDUCING THE INCIDENCE OF POSTOPERATIVE PELVIC ADHESIONS AFTER METICULOUS HEMOSTASIS IS ACHIEVED.
P880086|S202|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT, IDENTITY, IDENTITY ADX, INTEGRITY ADX, VERITY ADX, VICTORY, ZEPHER, MICRONY PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2011|12/04/2012|||APPR|APPROVAL FOR A MATERIAL CHANGE FROM MEDICAL GRADE POLYSULFONE TO BIOGRADE POLYSULFONE.
P910023|S263|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ATLAS II/+, EPIC +/II/II+, CURRENT RF/+/ACCEL, FORTIFY ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2011|12/04/2012|||APPR|APPROVAL FOR A MATERIAL CHANGE FROM MEDICAL GRADE POLYSULFONE TO BIOGRADE POLYSULFONE.
P030035|S082|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, FRONTIER II CRT-PS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2011|12/04/2012|||APPR|APPROVAL FOR A MATERIAL CHANGE FROM MEDICAL GRADE POLYSULFONE TO BIOGRADE POLYSULFONE.
P030054|S188|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS +HF, EPIC HF/+HF, PROMOTE RF/+/ACCEL, UNIFY CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/19/2011|12/04/2012|||APPR|APPROVAL FOR A MATERIAL CHANGE FROM MEDICAL GRADE POLYSULFONE TO BIOGRADE POLYSULFONE.
P890047|S034|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVIS OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2011|05/18/2011|||OK30|EXPAND THE ELECTRONIC BATCH RECORD SYSTEM TO INCLUDE ELECTRONIC DOCUMENTATION OF THE REACTOR/VESSEL CLEANING FOR OPHTHALMIC VISCOSURGICAL DEVICES.
P840064|S046|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC, VISCOAT AND DUOVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2011|05/18/2011|||OK30|EXPAND THE ELECTRONIC BATCH RECORD SYSTEM TO INCLUDE ELECTRONIC DOCUMENTATION OF THE REACTOR/VESSEL CLEANING FOR OPHTHALMIC VISCOSURGICAL DEVICES.
P990023|S011|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2011|05/18/2011|||OK30|EXPAND THE ELECTRONIC BATCH RECORD SYSTEM TO INCLUDE ELECTRONIC DOCUMENTATION OF THE REACTOR/VESSEL CLEANING FOR OPHTHALMIC VISCOSURGICAL DEVICES.
P980035|S217|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2011|05/18/2011|||OK30|CHANGES TO THE CLEANING PROCESS PERFORMED ON HYBRID COMPONENTS.
P090013|S016|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2011|05/18/2011|||OK30|CHANGES TO THE CLEANING PROCESS PERFORMED ON HYBRID COMPONENTS.
P010015|S118|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA & SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2011|05/18/2011|||OK30|CHANGES TO THE CLEANING PROCESS PERFORMED ON HYBRID COMPONENTS.
P020047|S034|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 OTW|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2011|05/12/2011|||OK30|A MANUAL TO AN AUTOMATED PROCESS CHANGE FOR PACKAGING LABELING INSPECTION.
P970020|S063|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ZETA RX/ULTRA RX/OTW|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2011|05/12/2011|||OK30|A MANUAL TO AN AUTOMATED PROCESS CHANGE FOR PACKAGING LABELING INSPECTION.
P970003|S126|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM GENERATORS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2011|05/20/2011|||OK30|ADDITION OF A THREAD GAUGING PROCESS TO THE HEADER ATTACHMENT PROCESS AND THE MODIFICATION OR FINAL INSPECTION PROCESS.
P030025|S093|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee||N|04/19/2011|07/25/2011|||APPR|APPROVAL FOR LABELING CHANGES TO UPDATE THE DIRECTIONS FOR USE TO INCLUDE ADDITIONAL DATA FROM THE TAXUS VISR STUDY.
P910054|S005|Toray Industries (America), Inc.|461 FIFTH AVENUE, 9TH FLOOR||NEW YORK|NY|10017||CATHETER, PERCUTANEOUS (VALVULOPLASTY)|TORAY INOUE BALLOON CATHETER|MAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2011|05/17/2011|||OK30|ADDITION OF A STERILIZER AT YOUR SETA PLANT FACILITY.
P820060|S029|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT AXSYM AFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2011|05/12/2011|||OK30|CHANGE THE SPECIFICATIONS FOR IN- PROCESS TESTING AND CUSTOMER RELEASE TESTING FOR AXSYM AFP AS A RESULT OF AN INTERNAL REVIEW OF THE PRODUCT RELATIVE TO UPDATED SPECIFICATION SETTING PROCEDURES.
P010019|S024|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|CIBA VISION LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2011|05/18/2011|||OK30|CHANGE IN THE SECONDARY PACKAGING SIDE LASER PRINTING INSPECTION SYSTEM.
P980035|S218|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2011|05/19/2011|||OK30|PROCESS STANDARDIZATION FOR SELECTED CLEANING OPERATIONS
P090013|S017|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2011|05/19/2011|||OK30|PROCESS STANDARDIZATION FOR SELECTED CLEANING OPERATIONS
P100021|S008|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2011|05/17/2011|||OK30|EXTENSION OF THE SCOPE OF SEVERAL ACTIVITIES CONDUCTED AS A THIRD PARTY STORAGE LOCATION.
P100040|S002|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2011|05/17/2011|||OK30|EXTENSION OF THE SCOPE OF SEVERAL ACTIVITIES CONDUCTED AS A THIRD PARTY STORAGE LOCATION.
P090006|S006|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2011|05/17/2011|||OK30|EXTENSION OF THE SCOPE OF SEVERAL ACTIVITIES CONDUCTED AS A THIRD PARTY STORAGE LOCATION.
P930039|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX NOVUS/VITATRON|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2011|05/18/2011|||OK30|ADDITION OF A SECOND SUPPLIER FOR TITANIUM NITRIDE COATED ELECTRODE COMPONENTS
P030036|S029|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE 4 FRENCH LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2011|05/18/2011|||OK30|ADDITION OF A SECOND SUPPLIER FOR TITANIUM NITRIDE COATED ELECTRODE COMPONENTS
P080006|S023|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LV/PLUS LV/STRAIGHT LV LEADS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2011|05/18/2011|||OK30|ADDITION OF A SECOND SUPPLIER FOR TITANIUM NITRIDE COATED ELECTRODE COMPONENTS
P090013|S018|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2011|05/18/2011|||OK30|ADDITION OF A SECOND SUPPLIER FOR TITANIUM NITRIDE COATED ELECTRODE COMPONENTS
P100029|S001|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2011|05/16/2011|||OK30|ADDITION OF ABATTOIRS FOR BOVINE TISSUE SOURCING.
N18033|S055|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2011|05/20/2011|||OK30|USE AN AUTOMATED DEVICE HISTORY RECORD CHECKLIST
P040045|S018|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2011|05/20/2011|||OK30|USE AN AUTOMATED DEVICE HISTORY RECORD CHECKLIST
P980022|S097|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC PARADIGM CONTINUOUS GLUCOSE MONITORING SYSTEMS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2011|05/20/2011|||OK30|INCLUSION OF AN ALTERNATE SUPPLIER FOR THE CASE ASSEMBLY USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL INSULIN PUMPS.
P010031|S249|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROTECTA & PROTECTA XT CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/25/2011|05/26/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES OF THE X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) MULTILAYER CERAMIC CAPACITOR FAMILIES.
P010015|S119|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA & SYNCRA CRT-P|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/25/2011|05/26/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES OF THE X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) MULTILAYER CERAMIC CAPACITOR FAMILIES.
P090013|S019|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|REVO MRI|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/25/2011|05/26/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES OF THE X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) MULTILAYER CERAMIC CAPACITOR FAMILIES.
P980035|S219|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/25/2011|05/26/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES OF THE X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) MULTILAYER CERAMIC CAPACITOR FAMILIES.
P980016|S295|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA + PROTECTA XT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/25/2011|05/26/2011|||APPR|APPROVAL FOR THE DESIGN CHANGES OF THE X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) MULTILAYER CERAMIC CAPACITOR FAMILIES.
P000025|S051|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2011|08/26/2011|||APPR|APPROVAL FOR SEVERAL MANUFACTURING PROCESS CHANGES FOR THE COCHLEAR IMPLANTS.
P990056|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2011|05/24/2011|||OK30|CHANGE IN MANUFACTURING SITE FROM BUILDINGS 351/352 TO BUILDING 761, ALL WITHIN THE ROCHE PENZBERG, GERMANY FACILITY FOR PRODUCTION OF A COMPONENT (BIOTINYLATED- AND RUTHENIUM-LABELED ANTIBODIES OR CONJUGATED ANTIBODIES) USED IN THIS ASSAY.
P000027|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA IMMUNOASSAY|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2011|05/24/2011|||OK30|CHANGE IN MANUFACTURING SITE FROM BUILDINGS 351/352 TO BUILDING 761, ALL WITHIN THE ROCHE PENZBERG, GERMANY FACILITY FOR PRODUCTION OF A COMPONENT (BIOTINYLATED- AND RUTHENIUM-LABELED ANTIBODIES OR CONJUGATED ANTIBODIES) USED IN THIS ASSAY.
P010015|S120|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA/SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2011|05/23/2011|||OK30|ALIGNMENT OF PROCESS SOFTWARE VERSIONS.
P010031|S250|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA/PROTECTA XT CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2011|05/23/2011|||OK30|ALIGNMENT OF PROCESS SOFTWARE VERSIONS.
P980016|S296|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/PROTECTA XT DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2011|05/23/2011|||OK30|ALIGNMENT OF PROCESS SOFTWARE VERSIONS.
P980035|S220|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2011|05/23/2011|||OK30|ALIGNMENT OF PROCESS SOFTWARE VERSIONS.
P080006|S024|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY PLUS/STRAIGHT|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2011|05/23/2011|||OK30|ALIGNMENT OF PROCESS SOFTWARE VERSIONS.
P000006|S023|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice||N|04/26/2011|05/25/2011|||OK30|MANUFACTURING CONTRACTOR CHANGE OF A COMPONENT.
P100040|S003|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/25/2011|||OK30|TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
P980016|S297|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P990001|S087|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+ C & T SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P980050|S061|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P980035|S221|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P950024|S031|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P930039|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P930029|S029|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CATH RF CONDUCTR/5 MM 8FR/RF MC 078 6022/CONTACTR CATHETER 7 FR 5MM/RF CONDUCTR MC SELF-REFERENCE CATHETER/RF ENHANCR II|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P920015|S076|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT/DF-1 CONNECTOR PORT PIN PLUG/ LEAD ADAPTOR/SPRINT/SPRINT QUATTRO/QUATTRO LEAD/SUBCUTANEOUS LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P900061|S102|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACCESSORY (UPSIZING SLEEVE) ACE/ACE 5434T/ACE HEADER/LEAD END PIN CAP|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P890003|S221|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE/CAPSURE MODEL/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P850089|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P830061|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P820003|S105|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADAPTOR:EPG SAFETY CABLE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P090013|S020|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P080006|S025|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P060039|S025|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P050010|S012|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-L TOTAL DISC REPLACEMENT|MJO|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/26/2011|07/10/2012|||APPR|APPROVAL OF A PROTOCOL FOR EXTENSION OF SHELF-LIFE FOR THE POLYETHYLENE INLAY COMPONENT FROM THREE (3) YEARS TO FIVE (5) YEARS.
P030036|S030|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P010031|S251|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P010015|S121|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2011|05/19/2011|||OK30|USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.
P030017|S119|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/2011|10/21/2011|||APPR|APPROVAL FOR THE INFINION 1X16 PERCUTANEOUS LEAD AND 2X8 SPLITTER.
P010023|S009|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2011|07/15/2011|||APPR|APPROVAL OF A MANUFACTURING PROCESS AND SUPPLIER CHANGE TO THE MAGNET CANISTER ASSEMBLY.
P100040|S004|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2011|05/17/2011|||OK30|EXTENSION OF THE SCOPE OF SEVERAL ACTIVITIES CONDUCTED AS A THIRD PARTY STORAGE LOCATION.
P100040|S005|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/27/2011|09/14/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060001|S012|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2011|05/26/2011|||OK30|OPTIMIZE THE ULTRASONIC CLEANING TIME USED IN THE MANUFACTURE OF THE DEVICE.
P080014|S007|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/27/2011|12/12/2011|||APPR|APPROVAL FOR MIGRATION OF THE CERVISTA HPV HR MANUAL ASSAY TO AN AUTOMATED PLATFORM HIGH-THROUGHPUT AUTOMATION. THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER TRADE NAME CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION AND IS INDICATED FOR:THE CERVISTA HPV HR TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNA FROM 14 HIGH-RISK HUMAN PAPILLOMAVIRUS (HPV) TYPES (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, AND 68) IN CERVICAL SPECIMENS. THE CERVISTA HPV HR TEST CANNOT DETERMINE THE SPECIFIC HPV TYPE PRESENT.  THE CERVISTA HPV HR TEST USES THE INVADER CHEMISTRY, A SIGNAL AMPLIFICATION METHOD FOR DETECTION OF SPECIFIC NUCLEIC ACID SEQUENCES. THIS METHOD USES TWO TYPES OF ISOTHERMAL REACTIONS:  A PRIMARY REACTION THAT OCCURS ON THE TARGETED DNA SEQUENCE AND A SECONDARY REACTION THAT PRODUCES A FLUORESCENT SIGNAL.THE CERVISTA HPV HR TEST IS INDICATED:1) TO SCREEN PATIENTS WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASCUS) CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLOSTOMY; AND 2) IN WOMEN 30 YEARS AND OLDER THE CERVISTA HPV HR TEST CAN BE USED WITH CERVICAL CYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.  CERVICAL SPECIMENS THAT MAY BE TESTED WITH THE CERVISTA HPV HR TEST INCLUDE THE FOLLOWING PRESERVATION SYSTEM COLLECTION MEDIA AND COLLECTION DEVICES:¿ THINPREP PAP TEST PRESERVCYT SOLUTION¿ BROOM-TYPE DEVICE (E.G., ROVERS CERVEX BRUSH, WALLACH PAPETTE), OR ENDOCERVICAL BRUSH/SPATULA.THE CERVISTA HPV HR TEST MAY BE PERFORMED EITHER MANUALLY OR USING THE AUTOMATED CERVISTA HIGH-THROUGHPUT AUTOMATION SYSTEM.  (CORRECTED STATEMENT NEEDS TO BE ADDED TO DATABASE.)
P030031|S033|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL CATHETER|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2011|01/13/2012|||APPR|APPROVAL FOR A SECOND SOURCE SUPPLIER OF A CATHETER COMPONENT.
P040036|S024|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL CATHETER|LPB|CV|135 Review Track For 30-Day Notice||N|04/27/2011|01/13/2012|||APPR|APPROVAL FOR A SECOND SOURCE SUPPLIER OF A CATHETER COMPONENT.
P080004|S007|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|ISERT PY-60AD|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/27/2011|06/15/2011|||APPR|APPROVAL FOR PACKAGING CHANGES TO THE MODEL PY-60AD.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT MODEL PY-60ADC AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
P100029|S002|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2011|09/26/2011|||APPR|APPROVAL FOR AN INCREASE IN THE MAXIMUM EXPOSURE TIME OF LIQUID STERILANT.
P030052|S006|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/28/2011|05/26/2011|||APPR|APPROVAL FOR A LABELING CHANGE TO THE UROVYSION BLADDER CANCER KIT PACKAGE INSERT TO CORRECT AN INACCURACY IN A LABELING SCHEMATIC IN THE UROVYSION PACKAGE INSERT 30-608358 IDENTIFIED DURING A REVIEW OF THE PACKAGE INSERT.
P000044|S026|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTICS PRODUCTS HBSAG REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2011|05/11/2011|||OK30|CHANGE IN THE PROCESS OF PREPARING ANTIFOAM SOLUTION AND THE STORAGE CONDITIONS OF PREPARED ANTIFOAM SOLUTION.
P010031|S252|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/2011|08/18/2011|||APPR|APPROVAL FOR DESIGN, MATERIALS, AND MANUFACTURING CHANGES TO THE HYBRIDS USED IN THE GEN2 AND ADAMS HYBRID PLATFORMS.
P100018|S001|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/28/2011|06/27/2011|||APPR|APPROVAL OF  POST- APPROVAL STUDY PROTOCOL.
P980016|S298|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/2011|08/18/2011|||APPR|APPROVAL FOR DESIGN, MATERIALS, AND MANUFACTURING CHANGES TO THE HYBRIDS USED IN THE GEN2 AND ADAMS HYBRID PLATFORMS.
P030022|S018|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/26/2011|||OK30|USE OF AN ALTERNATIVE MANUFACTURING SUPPLIER.
P060001|S013|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/17/2011|||OK30|CHANGES IN THE ELECTROPOLISHING PREPARATION CLEANING PROCESS
P090003|S011|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/31/2011|||OK30|ADDITION OF A NEW STERILIZATION CHAMBER.
P980016|S299|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/PROTECTA DR/VR/PTOTECTA XT DR/VR/INSYNC II/III MARQUIS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/26/2011|||OK30|UPDATE TO PROCESS OPERATION DESCRIPTIONS AND THE IMPLEMENTATION OF NEW TEST MONITORING FOR PACKAGING.
P010031|S253|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D/PROTECTA/XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/26/2011|||OK30|UPDATE TO PROCESS OPERATION DESCRIPTIONS AND THE IMPLEMENTATION OF NEW TEST MONITORING FOR PACKAGING.
P090013|S021|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/26/2011|||OK30|UPDATE TO PROCESS OPERATION DESCRIPTIONS AND THE IMPLEMENTATION OF NEW TEST MONITORING FOR PACKAGING.
P980035|S222|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM/ADVISA DR/KAPPA 700/800/900/SIGMA/MEDTRONIC 350 IPG SERIES/ENPULSE/AT500 SYSTEMS IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/26/2011|||OK30|UPDATE TO PROCESS OPERATION DESCRIPTIONS AND THE IMPLEMENTATION OF NEW TEST MONITORING FOR PACKAGING.
P100010|S010|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/29/2011|06/28/2011|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE COMPATIBILITY FOR USE WITH THE MEDTRONIC ACHIEVE MAPPING CATHETER.
P990001|S088|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPGS/C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/26/2011|||OK30|UPDATE TO PROCESS OPERATION DESCRIPTIONS AND THE IMPLEMENTATION OF NEW TEST MONITORING FOR PACKAGING.
P970012|S084|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2011|05/26/2011|||OK30|UPDATE TO PROCESS OPERATION DESCRIPTIONS AND THE IMPLEMENTATION OF NEW TEST MONITORING FOR PACKAGING.
P000006|S024|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/02/2011|02/13/2012|||APPR|APPROVAL FOR 1) A CHANGE IN THE ANGLE OF THE TUBING ON THE CYLINDER FROM THE CURRENT 45 DEGREES TO 0 DEGREES ANGLE TO IMPROVE THE EASE OF IMPLANTATION; AND 2) TO CHANGE THE TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750.
P040050|S008|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2011|05/27/2011|||OK30|IMPLEMENTATION OF A NEW HEAT SEALING INSTRUMENT FOR FINAL PACKAGE MANUFACTURING.
P070015|S071|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2011|05/31/2012|||APPR|APPROVAL TO ADD AN ALTERNATIVE COMPRESSED GAS IN THE MANUFACTURING OF THE SUBJECT DEVICE.
P040048|S014|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM PACKAGE INSERT|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/02/2011|06/02/2011|||APPR|APPROVAL FOR ADDING INFORMATION ABOUT MRI SAFETY TO THE PACKAGE INSERT AND PATIENT LABELING.
P880086|S203|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/2011|08/03/2011|||APPR|APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.
P030035|S083|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|FRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PS|LWO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/2011|08/03/2011|||APPR|APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.
P880006|S071|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/2011|08/03/2011|||APPR|APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.
P970013|S040|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MICRONY FAMILY OF PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/2011|08/03/2011|||APPR|APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.
P910023|S264|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable pulse generator, pacemaker (non-CRT)|CADENCE FAMILY OF ICDS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/2011|08/03/2011|||APPR|APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.
P030054|S189|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/02/2011|08/03/2011|||APPR|APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.
P080006|S026|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2011|06/02/2011|||OK30|ADDITION OF AN ADDITIONAL TESTING LABORATORY FOR STERILIZATION.
P020018|S038|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2011|05/17/2011|||OK30|ALTERNATE SUPPLIER OF GRAFT MATERIAL.
P990056|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P000027|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA IMMUNOASSAY|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P910073|S097|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE TACHY LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|06/02/2011|||OK30|REDUCTION IN SAMPLE SIZE
P090013|S022|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC REVO MRI SURESCAN PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|05/26/2011|||OK30|RELOCATION OF A STERILIZER SYSTEM WITHIN AND EXISTING LOCATION.
P020004|S062|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|11/10/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN PHOENIX, ARIZONA.
P970003|S127|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM PULSE GENERATORS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|06/03/2011|||OK30|MAKE CHANGES TO SOFTWARE USED IN AN ELECTRICAL TESTING SYSTEM.
P060007|S014|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIMATORY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|06/01/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.
P100034|S001|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOCURE NOVOTTF-100A SYSTEM|NZK|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/04/2011|01/03/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050051|S012|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|06/01/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.
P080023|S008|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|06/01/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.
P060035|S008|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|06/01/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.
P050042|S012|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|06/01/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.
P980007|S020|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|07/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE.
P910007|S029|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2011|07/22/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE.
P980035|S223|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA IPG|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2011|10/04/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SINGAPORE PTE LTD., IN SINGAPORE.
P830061|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE BIPOLAR LEAD|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2011|10/04/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SINGAPORE PTE. LTD, IN SINGAPORE.
P030005|S076|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTRAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2011|06/02/2011|||OK30|VARIOUS CHANGES IN HYBRID LEVEL TEST.
P990081|S011|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/23/2011|09/27/2011|||APPR|APPROVAL FOR THE ADDITION OF A STRAINER TYPE BARRIER TO THE CURRENT DAB DISPENSER RETAINER DESIGN, COLORIZATION OF STOP BARREL, AND ASSEMBLY EQUIPMENT UPDATES TO ACCOMMODATE THE MODIFIED RETAINER.
P060008|S070|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/06/2011|05/24/2011|||APPR|APPROVAL OF THE POST- APPROVAL STUDY PROTOCOL.
P880086|S204|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SUSTAIN XL FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/06/2011|06/08/2011|||APPR|APPROVAL FOR THE NEW SUSTAIN XL PACEMAKER MODELS, PREDICATED OFF THE VICTORY/ZEPHYR FAMILY OF PACEMAKER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUSTAIN XL DR/SR AND SUSTAIN XL DC/SC AND IS INDICATED FOR INDICATIONS AND USAGE:   IMPLANTATION OF SUSTAIN PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO:1) SYNCOPE2) PRESYNCOPE3) FATIGUE4) DISORIENTATION5) OR ANY COMBINATION OF THOSE SYMPTOMS.RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY.  DUAL-CHAMBER PACING (MODELS PM2134 AND PM2136 ONLY) IS INDICATED FOR THOSE PATIENTS EXHIBITING:1) SICK SINUS SYNDROME2) CHRONIC, SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK3) RECURRENT ADAMS-STOKES SYNDROME4) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT.ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV ANDINTRAVENTRICULAR CONDUCTION SYSTEMS.VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND:1) NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARREST2) CHRONIC ATRIAL FIBRILLATION3) SEVERE PHYSICAL DISABILITY.AF SUPPRESSION (MODELS PM2134 AND PM2136 ONLY) IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P020026|S085|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY STENT|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/2011|01/26/2012|||APPR|APPROVAL TO INTEGRATE THE XTEND MANUFACTURING PROCESS INTO THE CYPHER STENT MOUNTED ON THE SONIX RX DELIVERY SYSTEM.
P020055|S002|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY|NKF|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/23/2011|09/27/2011|||APPR|APPROVAL FOR THE ADDITION OF A STRAINER TYPE BARRIER TO THE CURRENT DAB DISPENSER RETAINER DESIGN, COLORIZATION OF STOP BARREL, AND ASSEMBLY EQUIPMENT UPDATES TO ACCOMMODATE THE MODIFIED RETAINER.
P030052|S007|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT ASSAY|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2011|06/01/2011|||OK30|IMPLEMENTATION OF PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, A NEW SONICATION EQUIPMENT, A NEW AMINATION/LABELING PROCEDURE, AND A SUPPLEMENTAL DNA PURIFICATION PROCESSING STEP TO REDUCE RNA CARRY-OVER.
P070015|S072|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|10/04/2011|||APPR|APPROVAL FOR AUTOMATION OF THE EXISTING BALLOON NECKING PROCESS.
P970020|S064|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTILINK ZETA CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|10/04/2011|||APPR|APPROVAL FOR AUTOMATION OF THE EXISTING BALLOON NECKING PROCESS.
P020047|S035|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION & ML8 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|10/04/2011|||APPR|APPROVAL FOR AUTOMATION OF THE EXISTING BALLOON NECKING PROCESS.
P820021|S033|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|CHANGE THE ALTERNATE RAW MATERIAL SOURCING FOR (VIFILCON A FORMULATION) SOFT CONTACT LENS MATERIALS.
P860057|S079|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PERIMOUNT BIOPROSTHESES|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|09/21/2011|||APPR|APPROVAL FOR NEW EDDY CURRENT TEST EQUIPMENT.
P060022|S011|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|ADDITION OF AN ALTERNATE FACILITY AS A SOURCE OR THE AKREOS LENS BUTTON AND AN ALTERNATE SUPPLIER OF METHYL METHACRYLATE.
P080006|S027|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
P040014|S017|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/06/2011|||OK30|IMPLEMENT AN ADDITIONAL MANUFACTURING REWORK STEP.
P040042|S022|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/06/2011|||OK30|IMPLEMENT AN ADDITIONAL MANUFACTURING REWORK STEP.
P980016|S300|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/MAXIMO/INTRINSIC/PROTECTA/PROTECTA XT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.
P010031|S254|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICD/CONSULTA/CONCERTO II/MAXIMO II CRT-D/INSYNC II/III MARQUIS/MARQUIS DR/INSYNC MARQUIS/MAXIMO/SENTRY||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.
P010015|S122|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|SYNCRA/CONSULTA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.
P090013|S023|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.
P980035|S224|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/SIGMA/RELIA/ADVISA DR/ENRHYTHM IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.
P890003|S223|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|06/08/2011|||OK30|CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.
P910001|S047|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|01/13/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO.
P960042|S029|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATHS (SLS)|MFA|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2011|01/13/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO.
N18286|S021|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/09/2011|07/09/2011|||APPR|APPROVAL FOR A CHANGE IN SOME OF THE COMPONENTS CONTAINED IN THE GELFOAM PLUS KIT AS WELL AS THE INTRODUCTION OF AN ALTERNATIVE GELFOAM PLUS KIT  GELFOAM PLUS COMPRESSED.  THE COMPONENT CHANGES WILL SUBSTITUTE PREFILLED SALINE SYRINGES AND A NEEDLELESS TRANSFER DEVICE FOR THE STANDARD SALINE VIALS AND NEEDLE-SYRINGE.  THE COMPONENTS HAVE BEEN CLEARED/ APPROVED PREVIOUSLY.  THE PURPOSE OF THE GELFOAM PLUS KIT IS TO PROVIDE THE CONVENIENCE OF CO-PACKAGED COLLAGEN SPONGE, SALINE DILUENT AND HUMAN THROMBIN TO A PHYSICIAN DURING SURGERY.
P010015|S123|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA/SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2011|06/09/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.
P980016|S301|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/II/II M4/PROTECTA/XT/PROTECT XT M4/PROTECTA M4/SECURA/SECURA M4/VIRTUOSO/II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2011|06/09/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.
P010031|S255|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONCERTO II/CONSULTA/DF4/INSYNC II/III/MAXIMO/SENTRY/MAXIMO II/II M4/PROTECTA XT/PROTECTA/PROTECTA XT M4/M4||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2011|06/09/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.
P090013|S024|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2011|06/09/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.
P890003|S224|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2011|06/09/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.
P980035|S225|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2011|06/09/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.
P090018|S009|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2011|07/07/2011|||APPR|APPROVAL FOR THE USER INTERFACE SOFTWARE CHANGE TO THE ESTEEM COMMANDER PROGRAMMER.
P010030|S028|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE BEFIBRILLATOR|MVK|CV|||N|05/10/2011|07/07/2011|||APPR|APPROVAL FOR USE OF THE E-ONE MOLI ENERGY 1HR18650B (2.25AH) LITHIUM-ION BATTERY CELL WITH YOUR LIFEVEST MODEL 4000 WEARABLE DEFIBRILLATOR.
P910001|S048|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice||N|05/10/2011|06/08/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A DEVICE COMPONENT.
P960042|S030|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice||N|05/10/2011|06/08/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A DEVICE COMPONENT.
P100023|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2011|06/07/2011|||OK30|CHANGES TO YOUR CUT-TO-LENGTH PROCESS DURING CATHETER ASSEMBLY.
P910023|S265|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|135 Review Track For 30-Day Notice||N|05/11/2011|09/20/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF A CIRCUIT COMPONENT.
P030054|S190|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF FAMILY OF CRT-DS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2011|09/20/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF A CIRCUIT COMPONENT.
P000023|S006|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM|LZD|DE|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/11/2011|01/31/2012|||APPR|APPROVAL FOR LABELING CHANGES TO UPDATE THE OWNER AND COMPANY NAME, MANUFACTURING SUITE, STANDARDIZATION OF THE PRODUCT NAMES, AND ADVERSE EVENTS SECTION RELATED TO COMPLETION OF THE POST-APPROVAL STUDY.
P020004|S063|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2011|06/08/2011|||OK30|AUTOMATION OF A BONDING PROCESS.
P000035|S006|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM|MPI|DE|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/11/2011|01/31/2012|||APPR|APPROVAL FOR LABELING CHANGES TO UPDATE THE OWNER AND COMPANY NAME, MANUFACTURING SUITE, STANDARDIZATION OF THE PRODUCT NAMES, AND ADVERSE EVENTS SECTION RELATED TO COMPLETION OF THE POST-APPROVAL STUDY.
P010032|S038|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI NEUROSTIMULATION SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2011|09/20/2011|||APPR|APPROVAL TO ADD AN ALTERNATE SUPPLIER FOR THE FEED THROUGH ASSEMBLY.
P940035|S006|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|NMP22 BLADDERCHEK TEST KIT|NAH|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2011|11/15/2011|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ALERE SCARBOROUGH, INC. IN SCARBOROUGH, MAINE.
N18033|S056|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2011|06/10/2011|||OK30|REPLACEMENT OF A DIFFERENTIAL SCANNING CALORIMETER (DSC) FOR A PREVIOUS MODEL THAT IS NO LONGER SUPPORTED BY THE SAME MANUFACTURER.
P040045|S019|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON) BRAND LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2011|06/10/2011|||OK30|REPLACEMENT OF A DIFFERENTIAL SCANNING CALORIMETER (DSC) FOR A PREVIOUS MODEL THAT IS NO LONGER SUPPORTED BY THE SAME MANUFACTURER.
P910077|S115|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PACEART INTEGRATION|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2011|06/21/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE LATITUDE PACEART INTEGRATION (LPI) SOFTWARE, MODEL 6472 V1.01.
P050043|S005|MORRIS INNOVATIVE RESEARCH INC|907 W.SECOND ST||BLOOMINGTON|IN|47403||Device, hemostasis, vascular|FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2011|07/11/2011|||APPR|APPROVAL FOR: ADDING A CUFF STABILIZER SHEATH, MODIFYING THE SUTURE INDICATOR KNOTS AND UPDATING LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FISH- SP ADVANCED COMPRESSION DEVICE AND IS INDICATED FOR   "...FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5, 6, 7 OR 8 FRENCH PROCEDURAL SHEATHS."
P930039|S053|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|VITATRON PIROUET/S+/CRYSTALLINE ACTFIX/CAPSURE LEADS|NVY|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P830061|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/VITATRON EXCELLENCE +|NVY|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P850089|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP Z LEADS/VITATRON IMPULSE/EXCELLENCE S+/SS+/IMPULSE II LEADS|NVY|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P970012|S085|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 IPG|NVZ|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P920015|S077|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE SVC LEAD|LWS|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P820003|S106|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE PULSE GENERATOR AND PROGRAMMER|LWP|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P890003|S225|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE (DRUG ELUTING) LEAD & PROGRAMMER ACCESSORY|NVZ|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P930029|S030|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|VARIOUS FAMILIES OF ELECTROPHYSIOLOGY SYSTEMS|LPB|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P980035|S226|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P080006|S028|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY PLUS/ATTAIN ABILITY STRAIGHT LEADS|OJX|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P010015|S124|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|SYNCRA/CONSULTA CRT-P|OJX|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P010031|S256|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA/PROTECTA XT CRT-D||CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P980016|S302|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/XT DR/VR ICD|LWS|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P900061|S103|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL LEADS AND ACCESSORIES|LWS|CV|30-Day Notice||N|05/13/2011|06/10/2011|||OK30|CHANGE THE CLEANING AREA OF THE DEVICES.
P860004|S151|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2011|01/13/2012|||APPR|APPROVAL FOR A MANUFACTURING CHANGE RELATED TO THE DESICCANT INSPECTION STEP FOR THE SYNCHROMED II INFUSION PUMP, MODEL 8637.
P970051|S070|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2011|08/30/2011|||APPR|APPROVAL FOR A CHANGE TO THE DIAMETER SPECIFICATION OF THE WIRE USED IN THE ELECTRODES OF THE COCHLEAR IMPLANT SYSTEM.
P970051|S071|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2011|06/15/2011|||OK30|CHANGE FROM A MANUAL ASSEMBLY TO AN AUTOMATED ASSEMBLY OF THE CASE OF THE SOUND PROCESSOR BATTERY PACK.
P030024|S016|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2011|09/27/2011|||APPR|APPROVAL FOR SCALING UP OF A CONJUGATE MANUFACTURING PROCESS FROM 10MG TO 96MG.
P030026|S022|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2011|09/27/2011|||APPR|APPROVAL FOR SCALING UP OF A CONJUGATE MANUFACTURING PROCESS FROM 10MG TO 96 MG.
P840001|S185|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/2011|11/03/2011|||APPR|APPROVAL FOR THE RESTORESENSOR RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RESTORESENSOR RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM AND IS INDICATED FOR SPINAL CORD STIMULATION (SCS) AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING CONDITIONS:1) FAILED BACK SYNDROME (FBS) OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FBS OR HERNIATED DISK; 3) POSTLAMINECTOMY PAIN; 4) MULTIPLE BACK OPERATIONS; 5) UNSUCCESSFUL DISK SURGERY; 6) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 5) PERIPHERAL CAUSALGIA; 6) EPIDURAL FIBROSIS; 7) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; AND 8) COMPLEX REGIONAL PAIN SYNDROME (CRPS), REFLEX SYMPATHETIC DYSTROPHY (RSD), OR CAUSALGIA.
P040045|S020|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2011|06/08/2011|||OK30|EVALUATION OF THE AUTOMATION OF THE REPACKAGING ACTIVITIES CONDUCTED BY A QUALIFIED SUPPLIER.
N18033|S057|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2011|06/08/2011|||OK30|EVALUATION OF THE AUTOMATION OF THE REPACKAGING ACTIVITIES CONDUCTED BY A QUALIFIED SUPPLIER.
P100023|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2011|10/25/2011|||APPR|APPROVAL FOR CHANGES TO IN-PROCESS MONITORING (IPM) REQUIREMENTS.
N18033|S058|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2011|06/16/2011|||OK30|CHANGE IN THE SOFTWARE FOR PROCESSING LABORATORY DATA RELATED TO THE VISTAKON® (ETAFILCON A) BRAND AND VISTAKON® (SENOFILCON A) BRAND CONTACT LENSES.
P040045|S021|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2011|06/16/2011|||OK30|CHANGE IN THE SOFTWARE FOR PROCESSING LABORATORY DATA RELATED TO THE VISTAKON® (ETAFILCON A) BRAND AND VISTAKON® (SENOFILCON A) BRAND CONTACT LENSES.
P990012|S009|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY & CONFIRMATORY & PRECICONTROL HBSAG|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P010054|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBS|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P090007|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P090008|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P090009|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P980035|S227|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA, RELIA IPGS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2011|06/02/2011|||APPR|APPROVAL FOR AN INCREASE IN GOLD THICKNESS ON XE263 ACCELEROMETER.
P840001|S186|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3 IMPLANTABLE NEUROSTIMULATOR/SYNERGY FAMILY OF IMPLANTABLE NEUROST|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/16/2011|||OK30|IMPLEMENT OR CHANGE SOFTWARE USED FOR MANUFACTURING OF SEVERAL DEVICES.
P860004|S152|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMPS/INTRA-ARTERIAL VASCULAR CATHETERS/VASCULAR CATHETERS/INDURA 1P INTRATHECAL CATH|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/16/2011|||OK30|IMPLEMENT OR CHANGE SOFTWARE USED FOR MANUFACTURING OF SEVERAL DEVICES.
P960009|S116|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS/SOLETRA IMPLANTABLE NEUROSTIMULATOR/KINETRA IMPLANTABLE NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/16/2011|||OK30|IMPLEMENT OR CHANGE SOFTWARE USED FOR MANUFACTURING OF SEVERAL DEVICES.
P970004|S113|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/ACCESSORIES/ACCESSORY KITS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/16/2011|||OK30|IMPLEMENT OR CHANGE SOFTWARE USED FOR MANUFACTURING OF SEVERAL DEVICES.
P080025|S005|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS/LEADS/EXTENSION/TEST STIMULATION LEAD/KIT/ACCESSORIES/ACCESSORY KITS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/16/2011|||OK30|IMPLEMENT OR CHANGE SOFTWARE USED FOR MANUFACTURING OF SEVERAL DEVICES.
P990034|S022|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/16/2011|||OK30|IMPLEMENT OR CHANGE SOFTWARE USED FOR MANUFACTURING OF SEVERAL DEVICES.
P910023|S266|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT ACCEL VR/DR ICD|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/28/2011|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO LLC IN ARECIBO, PUERTO RICO.
P030035|S084|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|PROMOTE ACCEL CRT-D|NKE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/28/2011|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO LLC IN ARECIBO, PUERTO RICO.
P030054|S191|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKFLEX U/UNIFY CRT-D|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/28/2011|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO LLC IN ARECIBO, PUERTO RICO.
P960013|S065|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL STS|NVN|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2011|06/28/2011|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO LLC IN ARECIBO, PUERTO RICO.
P030017|S120|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2011|06/16/2011|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR COMPONENTS USED IN ASSEMBLY OF THE DEVICE.
P980006|S019|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2011|06/10/2011|||OK30|UPGRADE THE COGNEX SOFTWARE FOR THE AUTOMATED WET VISION AUTOMATED INSPECTION SYSTEM (AIS) TO VERSION 4.4.
P970051|S073|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2011|09/27/2011|||APPR|APPROVAL FOR WIDENING THE ACCEPTANCE WINDOW FOR THE INPUT FREQUENCY MANUFACTURING TEST FOR THE NUCLEUS FREEDOM BTE SPEECH PROCESSOR.
P970051|S074|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice||N|05/19/2011|08/30/2011|||APPR|APPROVAL FOR A CHANGE TO MOVE THE INNER AND OUTER MOULDING PROCESS OF A TRANSFORMER POD IN-HOUSE, AND MODIFY THE SHAPE OF THE INNER-MOULD.
P970051|S075|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2011|11/29/2011|||APPR|APPROVAL FOR A CHANGE IN TOLERANCE TO THE FEEDTHROUGH COMB SINTERED POWDER INJECTION MOLDING.
P970051|S076|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2011|06/15/2011|||OK30|EXTENSION OF THE CURE TIME IN THE MOULDING PROCESS.
P970051|S077|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2011|06/15/2011|||OK30|CHANGES TO THE PRODUCTION OF THE SOLID BALL ASSEMBLY ELECTRODE.
P030026|S023|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2011|06/14/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE MANUFACTURE AND STORAGE OF THE ANTIFOAM SOLUTION USED IN THE VITROS ANTI-HBC IGM CONJUGATE REAGENT.
P890003|S226|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARDIOSIGHT READER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2011|07/01/2011|||APPR|APPROVAL OF MODIFICATION TO THE 2490G SOFTWARE REQUIREMENTS SPECIFICATION TO ADD THE CRT-P DEVICE MODEL NUMBERS TO THE AUTO-ID LIST FOR THE MODEL 2020A CARDIOSIGHT READER.
P010015|S125|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SYNCRA/CONSULTA CRT-P|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2011|07/01/2011|||APPR|APPROVAL OF MODIFICATION TO THE 2490G SOFTWARE REQUIREMENTS SPECIFICATION TO ADD THE CRT-P DEVICE MODEL NUMBERS TO THE AUTO-ID LIST FOR THE MODEL 2020A CARDIOSIGHT READER.
P010047|S011|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/19/2011|05/10/2012|||APPR|APPROVAL FOR THE ADDITION OF NEOMEND, INCORPORATED, IRVINE, CALIFORNIA AS A SECOND SOURCE SUPPLIER FOR THE HUMAN SERUM ALBUMIN (HSA) PROTEIN CARTRIDGES FOR THE DEVICE.
P040045|S022|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|06/15/2011|||OK30|ADDITION OF A CURE TUNNEL LANE.
P030050|S011|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|03/22/2012|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER FOR AN INGREDIENT USED IN THE MANUFACTURE OF SCULPTRA.
P070014|S023|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|10/27/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ANGIOMED GMBH & CO. IN KARLSRUHE, GERMANY.
P060010|S009|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|06/14/2011|||OK30|MINOR FORMULATION CHANGE IN A RAW MATERIAL.
P840001|S187|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 IMPLANTABLE PULSE GENERATOR/SYNERGY/SYNERGY VERSITREL/RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|06/17/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE STERILIZER SYSTEM.
P960009|S117|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA/KINETRA/ACTIVA PC/SC/RC|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|06/17/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE STERILIZER SYSTEM.
P060010|S010|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2011|07/28/2011|||APPR|APPROVAL FOR A DESIGN CHANGE TO ADD AN ACCESS TETHER, CALLED THE SHORE LINE TO THE DEVICE.
P980037|S036|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANJIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2011|07/19/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE ULTRA CONSOLE TO MAKE IT MORE ROBUST TO FLUID INGRESS.
P090018|S010|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/20/2011|09/23/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100029|S003|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA HEART VALVE|LWR|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|12/22/2011|||APPR|APPROVAL FOR AN ADDITIONAL STERILIZATION SITE AND FOR FINAL PACKAGING OPERATIONS LOCATED AT ST. JUDE MEDICAL, PAMPULHA, BRAZIL.
P970004|S114|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/INTERSTIM II INS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|06/17/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE STERILIZER SYSTEM.
P080025|S006|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/INTERSTIM II INS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2011|06/17/2011|||OK30|ADDITION OF AN ETHYLENE OXIDE STERILIZER SYSTEM.
P000025|S052|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2011|07/22/2011|||APPR|APPROVAL FOR INTRODUCTION OF THE MINI BATTERY PACK, AN OPTIONAL EXTERNAL BATTERY PACK TO BE USED TO POWER THE TEMPO+, OPUS 1, AND OPUS2 AUDIO PROCESSORS.
P980037|S037|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2011|06/08/2011|||OK30|MODIFICATION OF A WIPING PROCEDURE.
N18033|S059|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2011|06/22/2011|||OK30|USE AN ELECTRONIC RAW MATERIAL TRACKING SYSTEM.
P040045|S023|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2011|06/22/2011|||OK30|USE AN ELECTRONIC RAW MATERIAL TRACKING SYSTEM.
P840001|S188|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 SYNERGY FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2011|06/22/2011|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR COMPONENTS USED IN THE FEEDTHROUGH ASSEMBLY
P080025|S007|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2011|06/22/2011|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR COMPONENTS USED IN THE FEEDTHROUGH ASSEMBLY
P960009|S118|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC/SOLETRA/KINETRA|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2011|06/22/2011|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR COMPONENTS USED IN THE FEEDTHROUGH ASSEMBLY
P970004|S115|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2011|06/22/2011|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR COMPONENTS USED IN THE FEEDTHROUGH ASSEMBLY
P980007|S021|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/24/2011|||OK30|CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN ARCHITECT TOTAL PSA AND ARCHITECT FREE PSA ASSAYS.
P910007|S030|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/24/2011|||OK30|CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN ARCHITECT TOTAL PSA AND ARCHITECT FREE PSA ASSAYS.
P890055|S034|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/2011|06/21/2011|||APPR|APPROVAL TO ADD A WARNING STATEMENT TO THE INSTRUCTIONS FOR USE.
P970004|S116|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION SYSTEM|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/2011|06/08/2011|||APPR|APPROVAL FOR THE ADDITION OF TWO PRECAUTION STATEMENTS TO THE LABELING OF THE MODEL 3037 PATIENT PROGRAMMER.
P080025|S008|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM  SACRAL NERVE STIMULATION SYSTEM|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/25/2011|06/10/2011|||APPR|APPROVAL FOR CHANGES TO THE LABELING FOR THE 3037 PATIENT PROGRAMMER TO ADD NEW PRECAUTIONS RELATING TO MODIFICATION OF THE DEVICE AND THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON THE PATIENT PROGRAMMERS ABILITY TO COMMUNICATE WITH THE NEUROSTIMULATOR.
P060007|S015|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/24/2011|||OK30|CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS.
P050051|S013|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/24/2011|||OK30|CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS.
P060035|S009|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/24/2011|||OK30|CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS.
P080023|S009|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/24/2011|||OK30|CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS.
P050042|S013|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/24/2011|||OK30|CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE SUBJECT ARCHITECT ASSAYS.
P010012|S267|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK LEADS/ACUITY LEADS/CONTAK RENEWAL PG/LIVIAN ICD/COGNIS ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/17/2011|||OK30|ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
P030005|S077|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR PG|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/17/2011|||OK30|ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
P050046|S011|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/17/2011|||OK30|ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
P910073|S098|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK/ ENDOTAK RELIANCE/ENDOTAK ENDURANCE LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/17/2011|||OK30|ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
P830060|S069|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TACHY ADAPTER (ACCESSORY)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/17/2011|||OK30|ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
P910077|S116|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/17/2011|||OK30|ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
P960006|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/17/2011|||OK30|ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
P960040|S244|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT PG/VENTAK PRIZM/VITALITY PG/TELIGEN PG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2011|06/17/2011|||OK30|ALTERNATE INGREDIENT FOR THE ADHESIVE USED IN STERILE PACKAGING.
P100023|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/04/2011|12/15/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P890003|S228|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/25/2011|08/25/2011|||APPR|APPROVAL FOR MODELS 2020B/C MEDTRONIC CARELINK EXPRESS MONITORS AND MODIFICATIONS TO THE MODEL 2490/G/H/J MEDTRONIC CARELINK REMOTE HOME MONITOR AND MODEL 2020A MEDTRONIC CARDIOSIGHT READER TO UPDATE DEVICE FIRMWARE.
P010015|S127|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA/SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2011|06/22/2011|||OK30|CHANGES TO TESTING SOFTWARE.
P980035|S229|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2011|06/22/2011|||OK30|CHANGES TO TESTING SOFTWARE.
P030032|S012|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|HYLAFORM (HYLAN B GEL); PREVELLE SILK|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/27/2011|07/18/2011|||APPR|APPROVAL FOR CHANGES IN THE METHODS AND SPECIFICATIONS FOR TESTING THE PREVELLE SILK FINAL PRODUCT (I.E., 1) CHANGING THE AVERAGE EXTRUSION FORCE SPECIFICATIONFROM LESS THAN 80N TO AN AVERAGE OF AVERAGE EXTRUSION FORCE SPECIFICATION OF LESS THAN 40N, 2) CHANGING THE MAXIMUM PEAK EXTRUSION FORCE SPECIFICATION OF LESS THAN 100N TO AN AVERAGE OF MAXIMUM PEAK EXTRUSION FORCE" SPECIFICATION OF LESS THAN 50N AND 3) CHANGING THE METHOD OF DETERMINING THE MAXIMUM PEAK EXTRUSION FORCE SPECIFICATION FROM THE HIGHEST SINGLE VALUE OBSERVED IN 10 SAMPLES TO AN AVERAGE OF THE MAXIMUM PEAK EXTRUSION FORCE TEST RESULTS OBSERVED IN 25 SAMPLES).
P040044|S038|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2011|07/21/2011|||APPR|APPROVAL FOR A CONTRACT STERILIZATION SITE, BEAMONE, LLC LOCATED IN MOUNTAIN VIEW, CALIFORNIA.
P010014|S031|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE|NRA|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/31/2011|07/29/2011|||APPR|APPROVAL FOR LABELING CHANGES TO THE SURGICAL TECHNIQUE BROCHURE FOR THE OXFORD PARTIAL KNEE SYSTEM THAT INCLUDE THE ADDITION OF INSTRUCTIONS FOR USE FOR THE SIGNATURE PERSONALIZED PATIENT CARE SYSTEM (PATIENT-MATCHED CUTTING/DRILLING GUIDES.)
P100023|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|06/29/2011|||OK30|CHANGES TO YOUR PROXIMAL HEAT SHRINKING REMOVAL INSPECTION PROCESS.
P860022|S058|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens,contact(rigid gas permeable)-extended wear|BOSTON EQUALENS/EQUALENS II|MWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|06/22/2011|||OK30|ALTERNATE SUPPLIER OF 0.2 MICRON FORMULATION FILTER.
P010062|S009|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens,contact(rigid gas permeable)-extended wear|BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR|MWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|06/22/2011|||OK30|ALTERNATE SUPPLIER OF 0.2 MICRON FORMULATION FILTER.
P060001|S014|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|06/27/2011|||OK30|ALTERNATE ETCHING PROCESS FOR SPHERE COMPONENTS.
P040002|S032|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK WITH INTUITRAK DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|06/30/2011|||OK30|ALTERNATE SUPPLIER OF SUTURE MATERIAL.
P000025|S053|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+  COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|09/15/2011|||APPR|APPROVAL FOR THE ADDITION OF A NEW IMPLANT CLEANING SYSTEM FOR CLEANING COCHLEAR COMPONENTS.
P000010|S022|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST V2.0|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|12/29/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC. IN SOMERVILLE, NEW JERSEY.
P000012|S031|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, V2.0|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|12/29/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC. IN SOMERVILLE, NEW JERSEY.
P060030|S020|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|12/29/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC. IN SOMERVILLE, NEW JERSEY.
P050028|S019|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST|MKT|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|12/29/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC. IN SOMERVILLE, NEW JERSEY.
P100020|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2011|12/29/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC. IN SOMERVILLE, NEW JERSEY.
P070015|S074|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2011|07/01/2011|||OK30|CHANGE TO A MANUFACTURING PROCESS OF SUPPLIED ACETONE.
P960058|S089|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2011|11/17/2011|||APPR|APPROVAL FOR A NEW OFF-THE-EAR SOUND PROCESSOR CALLED NEPTUNE AND ITS ASSOCIATED ACCESSORIES.  THE NEPTUNE PROCESSOR, WHEN USED WITH THE NEW AQUAMIC HEADPIECE, IS WATERPROOF.  IN ADDITION, A NEW VERSION OF SOUNDWAVE PROFESSIONAL SOFTWARE SUITE (SOUNDWAVE 2.1) IS INCLUDED IN THE SUPPLEMENT.
P010013|S036|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2011|06/29/2011|||OK30|CHANGE IN MANUFACTURING MATERIALS.
P090013|S026|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2011|06/29/2011|||OK30|A LEAD ASSEMBLY CRIMPING PROCESS IMPROVEMENT.
P930039|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX & CRYSTALLINE ACT FIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2011|06/29/2011|||OK30|A LEAD ASSEMBLY CRIMPING PROCESS IMPROVEMENT.
P020009|S074|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2011|06/30/2011|||OK30|IMPLEMENTATION OF THE USE OF A CLOSED-LOOP CONTROL (FEEDBACK), IN THE EXTRUSION OF THE TIE LAYER OF THE TRI-LAYER COMPONENT.
P040016|S072|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX BARE-METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2011|06/30/2011|||OK30|IMPLEMENTATION OF THE USE OF A CLOSED-LOOP CONTROL (FEEDBACK), IN THE EXTRUSION OF THE TIE LAYER OF THE TRI-LAYER COMPONENT.
P060008|S071|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2011|06/30/2011|||OK30|IMPLEMENTATION OF THE USE OF A CLOSED-LOOP CONTROL (FEEDBACK), IN THE EXTRUSION OF THE TIE LAYER OF THE TRI-LAYER COMPONENT.
P950020|S044|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||FLEXTOME CUTTING BALLOON DILATATION DEVICE||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2011|06/30/2011|||OK30|IMPLEMENTATION OF THE USE OF A CLOSED-LOOP CONTROL (FEEDBACK), IN THE EXTRUSION OF THE TIE LAYER OF THE TRI-LAYER COMPONENT.
P080014|S008|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2011|06/23/2011|||OK30|ADDITION OF A NEW SUPPLIER OF BOVINE SERUM ALBUMIN (BSA).
P080015|S004|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HUMAN PAPILLOMA VIRUS (HPV) 16/18|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2011|06/23/2011|||OK30|ADDITION OF A NEW SUPPLIER OF BOVINE SERUM ALBUMIN (BSA).
P900060|S042|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2011|06/30/2011|||OK30|CHANGE OF A SUPPLIER FOR LOCK WIRE COMPONENTS.
P900060|S043|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2011|06/30/2011|||OK30|ANALYTICAL SERVICES SUPPLIER CHANGE.
P900060|S044|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS/CARBO-SEAL ASCENDING & VALSALVA/ORBIS/OPTIFORM HEART VALVES|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2011|06/30/2011|||OK30|THE ADDITION OF A NEW OPTICAL OGP SMARTSCOPE SYSTEM TO AN EXISTING COMPONENT INSPECTION.
P050052|S032|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/2011|08/02/2011|||APPR|APPROVAL FOR THE ADDITION OF A NUMBER OF PRECAUTIONS TO THE INSTRUCTIONS FOR USE.
P050037|S029|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/02/2011|08/02/2011|||APPR|APPROVAL FOR THE ADDITION OF A NUMBER OF PRECAUTIONS TO THE INSTRUCTIONS FOR USE.
P970027|S014|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2011|06/22/2011|||OK30|MODIFICATION TO A SUPPLIER OF THE ANTIFOAM SOLUTION USED IN AXSYM ANTI-HCV.
P030005|S078|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2011|07/01/2011|||OK30|CHANGE TO ELIMINATE A SHEAR STRENGTH TEST AND A REDUCTION IN AN IONIC CONTAMINATION MONITOR TEST FREQUENCY.
P040045|S024|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENSES/CLEAR & VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|07/01/2011|||OK30|IMPLEMENTATION OF AN ALTERNATIVE TEST METHOD FOR THE RAW MATERIAL FOR VISTAKON.
P010012|S268|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2 IS-1 LEAD|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2011|08/05/2011|||APPR|APPROVAL FOR CHANGES TO THE POLYURETHANE TUBING SPECIFICATIONS AND THE ADDITION OF AN ALTERNATE POLYURETHANE TUBING SUPPLIER.
P100029|S004|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|10/13/2011|||APPR|APPROVAL FOR A CHANGE IN THE JAR SET ASSEMBLY PACKAGING AND ETHYLENE OXIDE STERILIZATION LOAD CONFIGURATION.
P980049|S064|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|07/01/2011|||OK30|ALTERNATE OVEN USED FOR REFLOW SOLDERING.
P060027|S031|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|07/01/2011|||OK30|ALTERNATE OVEN USED FOR REFLOW SOLDERING.
P880047|S016|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|06/30/2011|||OK30|ALTERNATIVE CYCLE PARAMETERS FOR THE MANUFACTURING PROCESS.
P040021|S018|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR & EPIC VALVES|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|10/13/2011|||APPR|APPROVAL FOR A CHANGE IN THE JAR SET ASSEMBLY PACKAGING AND ETHYLENE OXIDE STERILIZATION LOAD CONFIGURATION.
P100029|S005|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|07/01/2011|||OK30|AUTOMATED METHOD FOR STENT DIMENSIONAL INSPECTION.
P010019|S025|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|AIR OPTIX NIGHT & DAY AQUA (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|06/06/2011|11/02/2011|||APPR|APPROVAL FOR A TRADE NAME CHANGE TO THE SPHERICAL (LOTRAFILCON A) SOFT CONTACT LENSES WITH WETTING AGENT (L% COPOLYMER 845) IN PACKAGE SALINE, AND THE ADDITION OF DESCRIPTIVE TEXT FOR SYMBOLS APPEARING ON THE CARTONS, EXCEPT THE RX SYMBOL USED FOR "PRESCRIPTION USE," AS WELL AS THE TRADE NAME CHANGES TO ALL THE LOTRAFILCON A LENS DESIGNS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES:  SPHERICAL - AIR OPTIX NIGHT & DAY AQUA; TORIC - AIR OPTIX NIGHT & DAY AQUA ASTIGMATISM; MULTIFOCAL - AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL; AND MULTIFOCAL TORIC - AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL TORIC AND IS INDICATED FOR THE FOLLOWING:AIR OPTIXC NIGHT & DAY AQUA (LOTRAFILCON A) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO HAVE 1.50 DIOPTERS OR LESS OF ASTIGMATISM.  AIR OPTIX NIGHT & DAY AQUA FOR ASTIGMATISM (LOTRAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO HAVE 6.00 DIOPTERS (D) OR LESS OF ASTIGMATISM.AIR OPTIX NIGHT & DAY AQUA MULTIFOCAL (LOTRAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) AND/OR PRESBYOPIA IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY REQUIRE A READINGADDITION OF +4.00 DIOPTERS (D) OR LESS AND WHO HAVE 1.50 DIOPTERS OR LESS OF ASTIGMATISM...(SEE APPROVAL ORDER FOR ADDITIONAL STATEMENT DETIAL)
P840001|S189|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|07/06/2011|||OK30|UPDATING THE WELDING EQUIPMENT SOFTWARE AT A VENDOR.
P960009|S119|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|07/06/2011|||OK30|UPDATING THE WELDING EQUIPMENT SOFTWARE AT A VENDOR.
P970004|S117|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|07/06/2011|||OK30|UPDATING THE WELDING EQUIPMENT SOFTWARE AT A VENDOR.
P080025|S009|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2011|07/06/2011|||OK30|UPDATING THE WELDING EQUIPMENT SOFTWARE AT A VENDOR.
P080032|S007|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/03/2011|06/21/2011|||APPR|APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
P980035|S230|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2011|07/07/2011|||OK30|UPGRADE TO THE AUTO-WELDER EQUIPMENT SOFTWARE.
P090013|S027|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2011|07/07/2011|||OK30|UPGRADE TO THE AUTO-WELDER EQUIPMENT SOFTWARE.
P010031|S257|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA/PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2011|07/07/2011|||OK30|UPGRADE TO THE AUTO-WELDER EQUIPMENT SOFTWARE.
P980016|S303|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/VR/XT DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2011|07/07/2011|||OK30|UPGRADE TO THE AUTO-WELDER EQUIPMENT SOFTWARE.
P990001|S089|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPGS/C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2011|07/07/2011|||OK30|UPGRADE TO THE AUTO-WELDER EQUIPMENT SOFTWARE.
P010015|S128|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC/ INSYNC III, CRT IPG'S|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2011|07/07/2011|||OK30|UPGRADE TO THE AUTO-WELDER EQUIPMENT SOFTWARE.
P940015|S021|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC AND SYNVISC-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2011|07/07/2011|||OK30|REPLACEMENT OF A POLYETHYLENE CYLINDRICAL TANK WITH A STAINLESS STEEL ROTATING BLENDER SYSTEM.
P930014|S048|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ TORIC INTAOCULAR LENS|HQL|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/02/2011|10/25/2011|||APPR|APPROVAL FOR POST-APPROVAL STUDY PROTOCOL.
P040047|S020|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/08/2011|||OK30|ADDITION OF AN INSPECTION TEST AND ASSOCIATED EQUIPMENT, FOR THE COAPTITE INJECTABLE IMPLANT SYRINGE COMPONENT.
P050037|S030|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/08/2011|||OK30|INCLUSION OF BORE GAUGE TESTING TO INCOMING INSPECTION OF SYRINGE BARRELS FOR THE DEVICE.
P050052|S033|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/08/2011|||OK30|INCLUSION OF BORE GAUGE TESTING TO INCOMING INSPECTION OF SYRINGE BARRELS FOR THE DEVICE.
P050020|S036|Abbott Laboratories|1360 South Loop Road||Alameda|CA|94502||Sensor, glucose, invasive|FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/06/2011|||OK30|UPDATE TO THEIR FIRST ARTICLE INSPECTION (FAI) PROCEDURE.
P980006|S020|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/08/2011|||OK30|ADD AN ADDITIONAL RAW MATERIAL SUPPLIER.
P880086|S205|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PACEMAKER AND CRT-P DEVICES|NVZ|CV|||N|06/08/2011|07/22/2011|||APPR|APPROVAL FOR A CHANGE TO THE SEAL PLUG FOR THE SETSCREW (REFERRED TO AS THE SEPTUM IN THE SUBMISSION).
P030035|S085|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|PACEMAKER AND CRT-P DEVICES|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/08/2011|07/22/2011|||APPR|APPROVAL FOR A CHANGE TO THE SEAL PLUG FOR THE SETSCREW (REFERRED TO AS THE SEPTUM IN THE SUBMISSION).
P830061|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/VITATRON CRYSTALINE/EXCELLENCE PS+|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P850089|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE SS+/VITATRON IMPULSE II|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P890003|S229|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P920015|S078|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P930039|S056|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P980050|S062|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P010015|S129|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P030036|S032|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P060039|S026|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P080006|S029|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P090013|S028|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|11/18/2011|||APPR|APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT.
P980035|S231|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC 350 SERIES IPG/ADAPTA/ADVISA/AT500/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P010031|S258|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONCERTO II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P010015|S130|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LEAD/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P030036|S033|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD/SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P060039|S027|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P080006|S030|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY/PLUS LEAD/STRAIGHT LEADS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P090013|S029|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX LEAD & REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P830061|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS + LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P820003|S107|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOABLE COVER & EPG SAFETY CABLE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P850051|S075|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VITATRON LEGACY IPG|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P850089|S079|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SP/Z NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P890003|S230|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P900061|S104|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P920015|S079|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P930029|S031|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P930039|S057|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+/CAPSURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P950024|S032|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P970012|S086|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P980016|S304|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE LEAD/ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/II ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P980050|S063|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P990001|S090|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+C & VITATRON DA+T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2011|07/07/2011|||OK30|UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).
P960058|S090|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|09/12/2011|||APPR|APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE THICKNESS TO DIELECTRIC LAYERS OF THE SUBSTRATE AND IS INDICATED TO PROVIDE USEFUL HEARING TO INDIVIDUALS WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS.
P980016|S305|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|11/10/2011|||APPR|APPROVAL FOR ADDITION OF A CLEANING PROCESS AT THE SUPPLIER.
P010031|S259|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|11/10/2011|||APPR|APPROVAL FOR ADDITION OF A CLEANING PROCESS AT THE SUPPLIER.
P930014|S049|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice||N|06/09/2011|07/08/2011|||OK30|OPTIMIZED INITIATION PROCESSES AND CASTING FILTRATION FOR THE DEVICE.
P040020|S031|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|07/08/2011|||OK30|OPTIMIZED INITIATION PROCESSES AND CASTING FILTRATION FOR THE DEVICE.
P100029|S006|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|07/07/2011|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR STENT TUBING MATERIAL.
P070015|S075|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|01/06/2012|||APPR|APPROVAL FOR A NEW AUTOMATED TUBING EXTRUSION MEASUREMENT PROCESS.
P020047|S036|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|01/06/2012|||APPR|APPROVAL FOR A NEW AUTOMATED TUBING EXTRUSION MEASUREMENT PROCESS.
P970020|S065|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTILINK ZETA/PIXEL & ULTRA CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|01/06/2012|||APPR|APPROVAL FOR A NEW AUTOMATED TUBING EXTRUSION MEASUREMENT PROCESS.
P000053|S037|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS SPHINCTER 800 URINARY PROSTHESIS|EZY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2011|06/24/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS 800 CONTROL PUMP, A COMPONENT OF THE AMS SPHINCTER 800 URINARY PROSTHESIS.
P920047|S047|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II/PRIME HTD CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2011|07/19/2011|||APPR|APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE BLAZER II/PRIME HTD CATHETERS  ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510; CHILLI COOLED ABLATION SYSTEM  ELECTROPHYSIOLOGY CABLES, MODELS M0046810 AND M004620620; AND BLAZER II XP AND BLAZER PRIME CARDIAC ABLATION CATHETERS  ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510.
P980003|S029|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II CATHETER|LPB|CV|||N|06/09/2011|07/19/2011|||APPR|APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE BLAZER II/PRIME HTD CATHETERS  ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510; CHILLI COOLED ABLATION SYSTEM  ELECTROPHYSIOLOGY CABLES, MODELS M0046810 AND M004620620; AND BLAZER II XP AND BLAZER PRIME CARDIAC ABLATION CATHETERS  ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510.
P020025|S028|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP/PRIME XP CATHETER|OAD|CV|||N|06/09/2011|07/19/2011|||APPR|APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE BLAZER II/PRIME HTD CATHETERS  ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510; CHILLI COOLED ABLATION SYSTEM  ELECTROPHYSIOLOGY CABLES, MODELS M0046810 AND M004620620; AND BLAZER II XP AND BLAZER PRIME CARDIAC ABLATION CATHETERS  ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510.
P040012|S039|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2011|01/06/2012|||APPR|APPROVAL FOR A NEW AUTOMATED TUBING EXTRUSION MEASUREMENT PROCESS.
P030011|S011|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2011|05/16/2012|||APPR|APPROVAL FOR THE COMPANION 2 DRIVER SYSTEM.
P840001|S190|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/07/2011|||OK30|UPDATE STATISTICAL PROCESS CONTROL SOFTWARE.
P860004|S153|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/07/2011|||OK30|UPDATE STATISTICAL PROCESS CONTROL SOFTWARE.
P960009|S120|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/07/2011|||OK30|UPDATE STATISTICAL PROCESS CONTROL SOFTWARE.
P970004|S118|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF INS/LEADS/EXTENSION|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/07/2011|||OK30|UPDATE STATISTICAL PROCESS CONTROL SOFTWARE.
P080025|S010|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF INS/LEAD/EXTENSION|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/07/2011|||OK30|UPDATE STATISTICAL PROCESS CONTROL SOFTWARE.
P980016|S306|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/15/2011|||OK30|SIX CHANGES TO GEN2 HYBRID TESTER: 1) A CHANGE TO THE TEST DECIBEL LIMIT OF THE EGM CMR; 2) A CHANGE TO THE TELEMETRY B VIZSENSE; 3) A CHANGE TO THE R034 STRESS; 4) A CHANGE TO THE JTAG FULL ENERGY DELIVERY PULSE WIDTH; 5) A CHANGE TO LV1 CONTINUITY; AND 6) A CHANGE TO THE CURRENT DRAIN AVVD RF IDD.
P010031|S260|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/15/2011|||OK30|SIX CHANGES TO GEN2 HYBRID TESTER: 1) A CHANGE TO THE TEST DECIBEL LIMIT OF THE EGM CMR; 2) A CHANGE TO THE TELEMETRY B VIZSENSE; 3) A CHANGE TO THE R034 STRESS; 4) A CHANGE TO THE JTAG FULL ENERGY DELIVERY PULSE WIDTH; 5) A CHANGE TO LV1 CONTINUITY; AND 6) A CHANGE TO THE CURRENT DRAIN AVVD RF IDD.
P000029|S069|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2011|07/28/2011|||OK30|RELOCATION OF THE QUALITY CONTROL LABORATORY TO A NEW LOCATION WITHIN Q-MED AB¿S EXISTING FACILITY.
P050049|S007|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/01/2011|||OK30|ADDITION OF AN HBSAG POSITIVE PLASMA SUPPLIER AND A CHANGE TO QUALITY CONTROL TESTING.
P010001|S010|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|02/14/2012|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE POLISHING MACHINE AT THE PLOCHINGEN, GERMANY FACILITY.
P040012|S040|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2011|07/07/2011|||OK30|USE OF AN ALTERNATE RADIAL FORCE TESTER.
P950034|S040|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM|MCN|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2011|02/17/2012|||APPR|APPROVAL FOR IMPLEMENTING A NEW COMPRESSED AIR SYSTEM.
P970037|S006|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA / DELFIA XPRESS HAFP TEST SYSTEM|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2011|06/24/2011|||OK30|CHANGE IN THE TOPO (TRIOCTYLPHOSPHINE OXIDE) RAW MATERIAL TYPE USED IN THE MANUFACTURING OF THE DELFIA INDUCER.
P080006|S031|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2011|07/13/2011|||OK30|TRANSFER OF INCOMING INSPECTION ACTIVITIES FOR SPECIFIC COMPONENTS TO A DIFFERENT FACILITY.
P810002|S076|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/2011|08/11/2011|||APPR|APPROVAL FOR CHANGES TO THE SPECIFICATION RANGE FOR THE COURSES PER INCH (CPI) AND THICKNESS OF THE PTFE FABRIC USED IN THE CONSTRUCTION OF THE PTFE SEWING CUFF USED WITH THE MASTERS SERIES VALVES, AS WELL AS APPROVAL OF TWO CHANGES INTENDED TO OFFSET THE INCREASE IN THE FORCE REQUIRED FOR VALVE ROTATION (TORQUE) ASSOCIATED WITH THE FABRIC MODIFICATION.  THESE PROPOSED CHANGES ARE FOR THE INCREASE IN THE DIAMETER OF THE ROTATION SPRING AND RETAINER ID AND REDUCING THE LOWER LIMIT OF TORQUE FROM 2.0 IN-OZ TO 0.2 IN-OZ.
P850022|S018|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET ORTHOPAK NON-INVASIVE BONE STIMULATOR SYSTEM & BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/2011|08/11/2011|||APPR|APPROVAL FOR THE MODIFICATION OF THE SYSTEM SOFTWARE TO INCLUDE AN ADDITIONAL LINE OF CODE WHICH WOULD ALLOW THE REAL-TIME CLOCK TO RESET TO 'DAY ZERO' AFTER AN ELAPSED 365 DAYS, THIS RESET WOULD ALLOW YOUR DEVICE TO REMAIN FUNCTIONAL AFTER 365 DAYS OF INACTIVITY.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM AND ARE INDICATED FOR THE FOLLOWING: 1) THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED.  A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLE PROGRESSIVE SIGNS OF HEALING; AND  2) THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
P970003|S128|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM PULSE GENERATORS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2011|07/11/2011|||OK30|USE OF A NEW LASER MARKER IN THE MANUFACTURING PROCESS OF THE PULSE GENERATORS.
P100040|S006|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CATIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2011|07/13/2011|||OK30|REDUCTION IN THE NUMBER OF IN-PROCESS INSPECTION STEPS IN TWO MANUFACTURING PROCESSES OF THE DELIVERY SYSTEMS.
P070007|S031|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT WITH THE CAPTIVIA AND WITH THE XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2011|07/13/2011|||OK30|REDUCTION IN THE NUMBER OF IN-PROCESS INSPECTION STEPS IN TWO MANUFACTURING PROCESSES OF THE DELIVERY SYSTEMS.
P070027|S030|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2011|07/13/2011|||OK30|REDUCTION IN THE NUMBER OF IN-PROCESS INSPECTION STEPS IN TWO MANUFACTURING PROCESSES OF THE DELIVERY SYSTEMS.
P990020|S046|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2011|07/13/2011|||OK30|REDUCTION IN THE NUMBER OF IN-PROCESS INSPECTION STEPS IN TWO MANUFACTURING PROCESSES OF THE DELIVERY SYSTEMS.
P090018|S011|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2011|11/13/2012|||APPR|APPROVAL FOR THE EO STERILIZATION LOAD CONFIGURATION CHANGE FOR THE ESTEEM PRODUCT FAMILY.
P900060|S045|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|30-Day Notice||N|06/14/2011|07/13/2011|||OK30|ADDITION OF A NEW MOLDING SUPPLIER FOR THE MANUFACTURING OF COMPONENTS USED TO PACKAGE THE FINISHED DEVICE.
P010021|S020|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2011|09/15/2011|||APPR|APPROVAL FOR CHANGES TO IMPROVED METHOD OF ANTIFOAM 204 INCORPORATION INTO ANTI-HCV ASSAY REAGENT.
P040048|S015|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/14/2011|11/04/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980016|S307|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2011|07/13/2011|||OK30|MANUFACTURING PROCESS AND LOCATION CHANGE FOR THE DIODE USED IN THE HIGH VOLTAGE CHARGING TRANSFORMER.
P010031|S261|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2011|07/13/2011|||OK30|MANUFACTURING PROCESS AND LOCATION CHANGE FOR THE DIODE USED IN THE HIGH VOLTAGE CHARGING TRANSFORMER.
P900056|S106|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2011|03/01/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION LOCATED IN HEREDIA, COSTA RICA.
P000058|S044|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2011|10/17/2012|||APPR|APPROVAL FOR CHANGE IN RESIN USAGE LIFETIME.
P000054|S031|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2011|10/17/2012|||APPR|APPROVAL FOR CHANGE IN RESIN USAGE LIFETIME.
P050053|S022|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2011|10/17/2012|||APPR|APPROVAL FOR CHANGE IN RESIN USAGE LIFETIME.
P050006|S020|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2011|10/13/2011|||APPR|APPROVAL TO MODIFY AN ACCEPTANCE CRITERION FOR THE CONTROL CATHETER COMPONENT.
P950037|S097|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2011|02/24/2012|||APPR|APPROVAL FOR  ADDITION OF AN AUTOMATED PRODUCTION TEST PROCESS.
P820076|S025|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|ICS 3000 IMPLANT MODULE AUTOMATED TEST|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2011|02/24/2012|||APPR|APPROVAL FOR  ADDITION OF AN AUTOMATED PRODUCTION TEST PROCESS.
P070008|S024|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2011|02/24/2012|||APPR|APPROVAL FOR  ADDITION OF AN AUTOMATED PRODUCTION TEST PROCESS.
P000018|S045|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|135 Review Track For 30-Day Notice||N|06/20/2011|11/04/2011|||APPR|APPROVAL FOR CHANGING LUBING SUPPLIERS.
P950022|S077|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|CONNECTOR SLEEVE ACCESSORY KIT|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2011|08/05/2011|||APPR|APPROVAL FOR A CONNECTOR SLEEVE ACCESSORY KIT MODEL EX3151.  THE CONNECTOR SLEEVE IS INDICATED FOR USE WITH IS-4 AND DF-4 LEAD CONNECTORS TO FACILITATE THE CONNECTION TO A PACING SYSTEM ANALYZER AT THE TIME OF IMPLANT.
P030054|S192|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONNECTOR SLEEVE ACCESSORY KIT|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2011|08/05/2011|||APPR|APPROVAL FOR A CONNECTOR SLEEVE ACCESSORY KIT MODEL EX3151.  THE CONNECTOR SLEEVE IS INDICATED FOR USE WITH IS-4 AND DF-4 LEAD CONNECTORS TO FACILITATE THE CONNECTION TO A PACING SYSTEM ANALYZER AT THE TIME OF IMPLANT.
P010030|S029|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2011|08/03/2011|||APPR|APPROVAL FOR SEVERAL MINOR HARDWARE UPDATES TO LEAD-FREE ALTERNATE COMPONENTS FOR THE DEVICES.
P970003|S129|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|THERAPY PULSE GENERATORS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2011|07/20/2011|||OK30|UPGRADE OF THE AUTOMATED FUNCTIONAL TEST SYSTEM.
P010032|S039|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2011|11/02/2011|||APPR|APPROVAL TO ADD AN ELECTRONIC SWITCH SUPPLIER FOR THE DEVICE.
P940019|S025|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|NIO|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/20/2011|08/17/2011|||APPR|APPROVAL FOR LABELING CHANGES RELATED TO THE MR COMPATIBILITY OF THE DEVICE.
P050033|S013|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|DERMAL FILLER PRODUCT HYDRELLE (ELEVESS)|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/20/2011|03/09/2012|||APPR|APPROVAL FOR UPDATES TO THE APPROVED PRODUCT LABEL BASED ON THE RESULTS OF YOUR POST-APPROVAL CLINICAL STUDY.
P000025|S054|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2011|04/20/2012|||APPR|APPROVAL FOR A CHANGE TO THE PACKAGING CONFIGURATION OF YOUR SONATATI100 COCHLEAR IMPLANT AND THE IMPLANT TEMPLATE, SINGLE USE, FOR THE SONATATI100.  THIS CHANGE WILL ENABLE THE SONATA SINGLE USE TEMPLATE TO BE SHIPPED TOGETHER WITH THE SONATATI100 COCHLEAR IMPLANT INSIDE THE IMPLANT BOX.
P030031|S034|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER|OAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2011|12/21/2011|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REDUCED RECOMMENDED SALINE FLOW RATE (REDUCE BY ~50%; 2) INCREASE IN NUMBER OF IRRIGATION HOLES (FROM 6 TO 56); 3) DECREASE IN SIZE OF IRRIGATION HOLES (FROM 0.016¿ TO 0.0035¿ DIAMETER); AND 4) MODIFIED TIP ELECTRODE MATERIAL (FROM 90% PLATINUM/10% IRIDIUM TO 80% PALLADIUM/20% PLATINUM).THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES UNI-DIRECTIONAL CARTO XP THERMOCOOL SF NAV CATHETER, UNI-DIRECTIONAL CARTO 3 THERMOCOOL SF NAV CATHETER, AND UNI-DIRECTIONAL THERMOCOOL SF CATHETER AND IS INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RT GENERATOR, FOR THE TREATMENT OF: A) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER; B) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.  THE THERMOCOOL SF NAV DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH COMPATIBLE CARTO EP NAVIGATION SSYTEMS.  THE BIOSENSE WEBSTER THERMOCOOL SF DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORIES ARE INDICATED FOR USE IN CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.
P990071|S013|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER|OAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/20/2011|12/21/2011|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REDUCED RECOMMENDED SALINE FLOW RATE (REDUCE BY ~50%; 2) INCREASE IN NUMBER OF IRRIGATION HOLES (FROM 6 TO 56); 3) DECREASE IN SIZE OF IRRIGATION HOLES (FROM 0.016¿ TO 0.0035¿ DIAMETER); AND 4) MODIFIED TIP ELECTRODE MATERIAL (FROM 90% PLATINUM/10% IRIDIUM TO 80% PALLADIUM/20% PLATINUM).THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES UNI-DIRECTIONAL CARTO XP THERMOCOOL SF NAV CATHETER, UNI-DIRECTIONAL CARTO 3 THERMOCOOL SF NAV CATHETER, AND UNI-DIRECTIONAL THERMOCOOL SF CATHETER AND IS INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RT GENERATOR, FOR THE TREATMENT OF: A) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER; B) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.  THE THERMOCOOL SF NAV DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH COMPATIBLE CARTO EP NAVIGATION SSYTEMS.  THE BIOSENSE WEBSTER THERMOCOOL SF DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER AND RELATED ACCESSORIES ARE INDICATED FOR USE IN CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER.
P020009|S075|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MR CORONARY STENT SYSTEM & EXPRESS 2 OTW CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P060008|S072|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE MR CORONARY STENT SYSTEM & TAXUS LIBERTE OTW CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P040016|S073|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX MR CORONARY STENT SYSTEM & VERIFLEX OTW CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P060006|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MR PREMOUNTED STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P100023|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P900056|S107|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P920047|S048|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P020025|S029|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP, BLAZER PRIME XP & BLAZER XP RPM CARDIAC ABLATION CATHETERS & STERILE CABLES|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P980003|S030|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|03/23/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS.
P950020|S045|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CORONARY FLEXTOME CUTTING BALLOON||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2011|07/20/2011|||OK30|USE OF AN ALTERNATE MIXER.
P060022|S012|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track||N|06/21/2011|06/18/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE PRIMARY PACKAGING WHICH INCLUDES AN ALTERNATE PLASTIC VIAL AND INTRAOCULAR LENS (IOL) HOLDER.
P100023|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2011|07/13/2011|||OK30|ELIMINATION OF TWO REDUNDANT INSPECTION STEPS.
P050047|S017|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2011|07/21/2011|||OK30|CHANGE IN THE STERILIZATION VALIDATION METHOD FOR THE JUVÉDERM HYALURONATE GEL IMPLANTS.
P050047|S018|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2011|01/20/2012|||APPR|APPROVAL TO ADD ADDITIONAL TESTING ON TWO RAW MATERIALS USED IN THE MANUFACTURE OF THE DEVICE WHICH INCLUDED ADDITIONAL TESTING OF RAW MATERIALS.
P810031|S039|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2011|07/21/2011|||OK30|CHANGE THE TEST METHOD FOR BIOBURDEN TESTING OF FINISHED PRODUCT PRIOR TO MOIST HEAT STERILIZATION.
P070008|S025|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW-L BP LEADS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2011|07/22/2011|||OK30|APPROVAL FOR AN ALTERNATE STERILIZER.
P030052|S008|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|URO VYSION BLADDER CANCER KIT ASSAY|NSD|PA|30-Day Notice||N|06/23/2011|07/20/2011|||OK30|IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR RESTRICTION ENZYME DIGEST GEL ELECTROPHORESIS (DNA RESTRICTION ANALYSIS), CHANGE IN DIGEST RESTRICTION ENZYMES USED IN THE IN-PROCESS TEST, IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR DNA CONCENTRATION DETERMINATION BY UV/VIS ABSORBANCE SPECTROPHOTOMETRY, AND ADDITION OF AN INCOMING SCREENING TEST FOR DEXTRAN SULFATE.
P970051|S078|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|07/21/2011|||OK30|CHANGES TO: 1) THE TEST SYSTEMS (ACOUSTIC AND WIRELESS) TO UPDATE TEST EQUIPMENT AND FIRMWARE; 2) ADDITIONAL TESTS FOR THE DIGITAL SOUND PROCESSING MEMORY; 3) MODIFICATION TO TEST LIMITS; AND 4) MINOR CHANGES TO THE SYSTEM USER INTERFACE AND TEST REPORT FORMAT.
P000037|S023|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|07/20/2011|||OK30|VALIDATIONS FOR A MASS FINISHING PROCESS.
P950029|S060|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2011|08/18/2011|||APPR|APPROVAL FOR THE ADDITION OF THE DPLUS AND ACCELERATION AND ATRIAL VENTRICULAR DELAY REDUCTION PACING MODES ALONG WITH MINOR SOFTWARE UPDATES.
P930014|S050|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|GLOBAL VISION SCAN TVS PROOF-READER SYSTEM|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|07/21/2011|||OK30|CHANGE FROM A MANUAL PROOF-READING PROCESS TO AN AUTOMATED PROOF-READING SYSTEM.
P040020|S032|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|07/21/2011|||OK30|CHANGE FROM A MANUAL PROOF-READING PROCESS TO AN AUTOMATED PROOF-READING SYSTEM.
P880087|S019|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF RESTOR INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|07/21/2011|||OK30|CHANGE FROM A MANUAL PROOF-READING PROCESS TO AN AUTOMATED PROOF-READING SYSTEM.
P840060|S037|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF RESTOR INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|07/21/2011|||OK30|CHANGE FROM A MANUAL PROOF-READING PROCESS TO AN AUTOMATED PROOF-READING SYSTEM.
P810032|S060|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|ACRYSOF RESTOR INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|07/21/2011|||OK30|CHANGE FROM A MANUAL PROOF-READING PROCESS TO AN AUTOMATED PROOF-READING SYSTEM.
P970055|S010|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|MYM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|09/05/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTRIN INTERNATIONAL LTD IN DUBLIN, IRELAND.
P970054|S009|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY|MYL|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2011|09/05/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTRIN INTERNATIONAL LTD IN DUBLIN, IRELAND.
P020018|S039|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH RENU AAA ANCILLARY GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/23/2011|07/17/2012|||APPR|APPROVAL FOR A MODIFIED LABEL TO INCORPORATE INFORMATION FROM THE POST-APPROVAL STUDY.
P040013|S017|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21SGROWTH FACTOR ENHANCED MATRIX|NPZ|DE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/24/2011|12/06/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970003|S130|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/27/2011|07/29/2011|||APPR|APPROVAL FOR A MODIFICATION TO THE SERIAL ADAPTER CABLE POWER CONNECTOR.
P970018|S023|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM VACUUM PUMP SAFETY HAZARD|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2011|07/15/2011|||APPR|APPROVAL FOR VACUUM PUMP SAFETY HAZARD LABELING CHANGES.
P970051|S080|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/22/2011|||OK30|MODIFICATION TO CLEAN ROOM 2.
P030017|S121|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/27/2011|||OK30|ADD IN-HOUSE EQUIPMENT FOR THE CABLE ABLATION PROCESS.
P830061|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALINE AND VITATRON EXCELLENCE PS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/27/2011|||OK30|ADDITION OF SECOND SUPPLIER OF SILICONE TUBING.
P850089|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, CAPSURE Z NOVUS & VITATRON EXCELLENCE SS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/27/2011|||OK30|ADDITION OF SECOND SUPPLIER OF SILICONE TUBING.
P930039|S058|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALLINE ACTFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/27/2011|||OK30|ADDITION OF SECOND SUPPLIER OF SILICONE TUBING.
P990019|S007|DUSA PHARMACEUTICALS, INC.|25 UPTON DR.||WILMINGTON|MA|01887||SYSTEM, LASER, PHOTODYNAMIC THERAPY|BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR|MVF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/27/2011|07/07/2011|||APPR|APPROVAL FOR A SOFTWARE CHANGE TO ELIMINATE THE NEED TO ARTIFICIALLY LIMIT THE CYCLE LIFETIME FOR THE BLU-U TREATMENT LAMP SYSTEM.
P040043|S040|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2011|01/13/2012|12M-0056|01/19/2012|APPR|APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS.  THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ISOLATED LESIONS (NOT INCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA, IN PATIENTS WHO HAVE APPROPRIATE ANATOMY INCLUDING ADEQUATE ILIAC/FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM, AND >= 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.
P020009|S076|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS AND EXPRESS CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/25/2011|||OK30|REMOVAL OF AN IPA WASH STEP.
P040016|S074|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERFLEX (LIBERTE) CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/25/2011|||OK30|REMOVAL OF AN IPA WASH STEP.
P060008|S073|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/25/2011|||OK30|REMOVAL OF AN IPA WASH STEP.
P100023|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2011|07/25/2011|||OK30|REMOVAL OF AN IPA WASH STEP.
P040033|S021|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|30-Day Notice||N|06/28/2011|07/27/2011|||OK30|USE OF A NEW DEGREASING SYSTEM AT A CONTRACT MANUFACTURER.
P880086|S206|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|ACCENT FAMILY OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/28/2011|08/11/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE HYBRID USED IN THE DEVICES.
P030054|S193|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|EPIC HF/ATLAS + HF/PROMOTE/UNIFY FAMILY OF CRT-DS|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2011|08/17/2011|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.
P030035|S086|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-PS|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2011|08/17/2011|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.
P880006|S072|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2011|08/17/2011|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.
P880086|S207|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2011|08/17/2011|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.
P910023|S267|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE/CURRENT/FORTIFY FAMILY OF ICDS|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2011|08/17/2011|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.
P970013|S041|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|MICRONY FAMILY OF PACEMAKERS|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2011|08/17/2011|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PATIENT MANUALS PACKAGED WITH THE DEVICES.
P820003|S108|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOABLE COVER & EPG SAFETY CABLE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P850051|S076|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VITATRON LEGACY IPG|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P850089|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, CAPSURE Z NOVUS & VITATRON EXCELLENCE SS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P890003|S231|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P900061|S105|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P920015|S080|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P930039|S059|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALLINE ACTFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P950024|S033|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P970012|S087|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P980016|S308|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P980035|S232|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC 350 SERIES IPG/ADAPTA/ADVISA/AT500/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P980050|S064|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P990001|S091|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+C & VITATRON DA+T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P010015|S131|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LEAD/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P010031|S262|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P030036|S034|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD/SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P060039|S028|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P080006|S032|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P090013|S030|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX LEAD & REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P830061|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALINE AND VITATRON EXCELLENCE PS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2011|07/21/2011|||OK30|UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
P840001|S191|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2011|07/29/2011|||OK30|PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS.
P860004|S154|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER|LKK|HO|30-Day Notice||N|06/29/2011|07/29/2011|||OK30|PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS.
P960009|S121|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS|MHY|NE|30-Day Notice||N|06/29/2011|07/29/2011|||OK30|PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS.
P970004|S119|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF INS/LEADS/EXTENSION|EZW|GU|30-Day Notice||N|06/29/2011|07/29/2011|||OK30|PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS.
P990034|S023|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK|LKK|HO|30-Day Notice||N|06/29/2011|07/29/2011|||OK30|PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS.
P080025|S011|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF INS/LEAD/EXTENSION|EZW|GU|30-Day Notice||N|06/29/2011|07/29/2011|||OK30|PROCEDURE MODIFICATION TO MEET THE REQUIREMENTS OF UPDATED INDUSTRY STANDARDS.
P980035|S233|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, RELIA, SENSIA, & VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2011|07/28/2011|||OK30|FIVE CHANGES TO GEN2 HYBRID TESTER FINAL TEST SOLUTION:  1) UPDATE TO THE FORCE MEASURE_NGT2 MODULE; 2) UPDATE THE PULSE AMPLITUDE AND PULSE WIDTH TEST , PULSE AMPLITUDE 7500 MV AND AMPLITUDE 7500 MV TEST SEQUENCES; 3) WIDEN THE TOLERANCE OF THE STABILITY CHECK CRITERIA FOR THE PULSE AMPLITUDE AND PULSE WIDTH TEST ;4) UPDATE THE CONFIGURATION SETTINGS FOR THE PULSE AMPLITUDE 7500 MV AND UNIPOLAR BIPOLAR SWITCH TEST AND THE INTER-CHAMBER CROSSTALK TEST; AND 5) UPDATE THE ELECTRICALLY ERASABLE PROGRAMMABLE READ ONLY MEMORY (EEPROM) CYCLIC REDUNDANCY CHECK (CRC).
P970051|S082|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2011|08/19/2011|||APPR|APPROVAL TO ADD INSPECTION CHECKS.
P010014|S032|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|AMSONIC 9 STAGE WASH SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2011|07/28/2011|||OK30|INTRODUCTION OF NEW EQUIPMENT FOR CLEANING AND PASSIVATION OF THE METALLIC COMPONENTS OF THE OXFORD® PARTIAL KNEE SYSTEM.
P030009|S056|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2011|07/27/2011|||OK30|SEMI-AUTOMATION OF ONE OF THE INTEGRITY STENT MANUFACTURING WORK STEPS.
P050044|S018|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|AUTOMATED WASHER|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2011|07/26/2011|||OK30|USE OF AN AUTOMATED WASHER AS AN ALTERNATIVE TO MANUAL CLEANING OF EQUIPMENT AND COMPONENTS USED IN THE PRODUCTION OF VITAGEL SURGICAL HEMOSTAT.
P070022|S020|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|||N|06/29/2011|08/09/2011|||APPR|APPROVAL FOR A CHANGE OF THE ACCEPTANCE CRITERIA FOR THE DEPLOYMENT FORCE EXERTED ON A POLYURETHANE RING IN THE ADIANA CATHETER.
P010012|S269|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REPLACING LASER EQUIPMENT|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2011|07/28/2011|||OK30|CHANGE TO THE LASER WELD EQUIPMENT USED TO MANUFACTURE PACING LEADS.
P060029|S003|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Sealant,polymerizing|ETHICON OMNEX SURGICAL SEALANT|NBE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2011|02/03/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHICON LLC., IN SAN LORENZO, PUERTO RICO.
P980016|S309|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2011|07/29/2011|||OK30|ADDITIONAL DEVICE MODELS TO BE INCLUDED IN THE UPDATE TO STERILE PACKAGING SEALING PARAMETERS.
P010031|S263|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2011|07/29/2011|||OK30|ADDITIONAL DEVICE MODELS TO BE INCLUDED IN THE UPDATE TO STERILE PACKAGING SEALING PARAMETERS.
P980035|S234|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, RELIA, SENSIA, & VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2011|07/29/2011|||OK30|ADDITIONAL DEVICE MODELS TO BE INCLUDED IN THE UPDATE TO STERILE PACKAGING SEALING PARAMETERS.
P930014|S051|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2011|07/28/2011|||OK30|ADDITIONAL LAMINAR AIR FLOW HOODS IN THE ALCON IRELAND FACILITY.
P000021|S020|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/2011|11/23/2011|||APPR|APPROVAL FOR THE DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM.
P020027|S015|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/2011|11/23/2011|||APPR|APPROVAL FOR THE DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM.
P960043|S073|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/2011|08/24/2011|||APPR|APPROVAL FOR CHANGES TO YOUR PACKAGING AND PACKAGING INTEGRITY TESTING.
P100023|S008|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION  PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2011|07/27/2011|||OK30|ALTERNATE INHERENT VISCOSITY TEST METHOD FOR TESTING OF AESON-BLENDED RESIN AND ANNEALED GRADIENT OUTER TUBING COMPONENT, AND AN UPDATE OF ASSOCIATED SPECIFICATIONS.
P100017|S001|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV ASSAY|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2011|11/30/2011|||APPR|APPROVAL FOR A RAW MATERIAL CHANGE FOR TWO OF THE MICROVIALS USED TO MANUFACTURE THE REAGENT COMPONENTS IN THE ABBOTT REALTIME HCV AMPLIFICATION KIT WITHIN THE ABBOTT REALTIME HCV ASSAY.
P080026|S002|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV ASSAY|MKT|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2011|11/30/2011|||APPR|APPROVAL FOR A RAW MATERIAL CHANGE FOR TWO OF THE MICROVIALS USED TO MANUFACTURE THE REAGENT COMPONENTS IN THE ABBOTT REALTIME HBV AMPLIFICATION KIT WITHIN THE ABBOTT REALTIME HBV ASSAY.
P050028|S020|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|ROCHE COBAS TAQMAN HBV TESTS|MKT|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2011|03/20/2012|||APPR|APPROVAL FOR CHANGES TO YOUR ASSAY INSTRUMENTATION AND SOFTWARE PLATFORM COLLECTIVELY REFERRED TO AS THE CAP/CTM SECOND GENERATION SYSTEM.
P060030|S021|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS TAQMAN HCV TESTS|MZP|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2011|03/20/2012|||APPR|APPROVAL FOR CHANGES TO YOUR ASSAY INSTRUMENTATION AND SOFTWARE PLATFORM COLLECTIVELY REFERRED TO AS THE CAP/CTM SECOND GENERATION SYSTEM.
P970008|S058|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2011|12/09/2011|||APPR|APPROVAL FOR DEVICE AND MANUFACTURING MODIFICATIONS OF THE TIP OF THE CTC ADVANCED CATHETER COMPONENT OF THE TARGIS SYSTEM.
P930014|S052|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|FILL/FLUSH EXTRACTION SYSTEM FOR ACRYSOF, AND ACRYSOF RESTOR INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2011|07/21/2011|||OK30|CHANGE IN THE FILL/ FLUSH EXTRACTION SYSTEM FOR THE ACRYSOF AND ACRYSOF RESTOR INTRAOCULAR LENSES.
P040020|S033|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|FILL/FLUSH EXTRACTION SYSTEM FOR ACRYSOF, AND ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2011|07/21/2011|||OK30|CHANGE IN THE FILL/ FLUSH EXTRACTION SYSTEM FOR THE ACRYSOF AND ACRYSOF RESTOR INTRAOCULAR LENSES.
P100031|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2011|07/22/2011|||OK30|CHANGE WITHIN THE MANUFACTURING SITE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT OF THE STREPTAVIDIN- COATED MICROPARTICLES USED IN BOTH OF THESE ASSAYS.
P100032|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2011|07/22/2011|||OK30|CHANGE WITHIN THE MANUFACTURING SITE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT OF THE STREPTAVIDIN- COATED MICROPARTICLES USED IN BOTH OF THESE ASSAYS.
P970055|S011|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|MYM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/03/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR PREPARATION OF THE SENSITIVITY STANDARDS, USED AS A REFERENCE MATERIAL TO ESTABLISH THE CUT-OFF VALUE FOR THE DEVICE.
P930014|S053|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTROCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|07/26/2011|||OK30|REMOVAL OF DETERGENT FROM THE CLEANING PROCESS.
P040020|S034|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|07/26/2011|||OK30|REMOVAL OF DETERGENT FROM THE CLEANING PROCESS.
P930038|S067|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|04/15/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL, INC., IN MINNETONKA, MINNESOTA.
P100023|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|08/04/2011|||OK30|MANUFACTURING PROCESS STEP TO ENHANCE SCANNING AND DATA RETRIEVAL FUNCTION.
P970003|S131|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2011|08/11/2011|||OK30|CHANGE TO MODIFY THE ELECTRICAL TEST SYSTEM SOFTWARE.
P970003|S132|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM PULSE GENERATORS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|08/04/2011|||OK30|USE OF A NEW PIECE OF EQUIPMENT FOR A QUALITY SYSTEMS TEST.
P060037|S014|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|12/21/2011|||APPR|APPROVAL FOR THE ADDITION OF A NEW COMPRESSION MOLDING PRESS BY THE RAW MATERIAL SUPPLIER.
P030009|S057|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|07/27/2011|||OK30|CHANGE IN RECEIVING INSPECTION LOCATION FOR A COMPONENT.
P960016|S037|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|08/04/2011|||OK30|UPDATE THE UV TRIMMING PROCESS
P810002|S077|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|11/10/2011|||APPR|APPROVAL FOR ELIMINATING THE USE OF ONE METHOD FOR COATING THICKNESS IMAGE CAPTURE AND REPLACE IT WITH A NEW METHOD.
P980037|S038|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2011|11/02/2011|||APPR|APPROVAL FOR A CHANGE OF THE ANGIOJET ULTRA SYSTEM CONSOLE SOFTWARE TO VERSION V2.0.14.
P100023|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|07/27/2011|||OK30|SOFTWARE UPGRADES TO THE STENT INSPECTION SYSTEM.
P100023|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM MONORAIL|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|08/04/2011|||OK30|CHANGE TO THE INFLATION MANIFOLD COMPONENT INSPECTION PROCESS.
P060008|S074|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|08/04/2011|||OK30|CHANGE TO THE INFLATION MANIFOLD COMPONENT INSPECTION PROCESS.
P040016|S075|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|LIBERTE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|08/04/2011|||OK30|CHANGE TO THE INFLATION MANIFOLD COMPONENT INSPECTION PROCESS.
P950020|S046|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CUTTING BALLOON ULTRA 2 MONORAIL AND FLEXTOME CUTTING BALLOON MONORAIL||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|08/04/2011|||OK30|CHANGE TO THE INFLATION MANIFOLD COMPONENT INSPECTION PROCESS.
P980035|S235|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, RELIA, SENSIA, & VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P010031|S264|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P990001|S092|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+C & VITATRON DA+T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P970012|S088|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P980016|S310|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P890003|S232|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P850051|S077|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VITATRON LEGACY|LWO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P010015|S132|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN LEAD/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P090013|S031|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX LEAD & REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P900061|S106|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/04/2011|||OK30|MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
P840001|S192|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/05/2011|||OK30|CHANGES TO THE BLISTER SEALING OPERATION AND THE INSPECTION SPECIFICATIONS FOR THAT OPERATION.
P960009|S122|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/05/2011|||OK30|CHANGES TO THE BLISTER SEALING OPERATION AND THE INSPECTION SPECIFICATIONS FOR THAT OPERATION.
P970004|S120|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF INS/LEADS/EXTENSION|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/05/2011|||OK30|CHANGES TO THE BLISTER SEALING OPERATION AND THE INSPECTION SPECIFICATIONS FOR THAT OPERATION.
P080025|S012|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF INS/LEAD/EXTENSION|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/05/2011|||OK30|CHANGES TO THE BLISTER SEALING OPERATION AND THE INSPECTION SPECIFICATIONS FOR THAT OPERATION.
P860003|S060|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2011|08/05/2011|||OK30|CHANGE IN SUPPLIER FOR A COMPONENT.
P100023|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLIYAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|08/04/2011|||OK30|OPTIMIZATION OF IN-PROCESS MANUFACTURING INSPECTIONS.
P100023|S013|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2011|04/24/2012|||APPR|APPROVAL FOR REVISIONS TO GUIDEWIRE VISUAL ACCEPTANCE CRITERIA.
P080015|S005|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2011|08/02/2011|||OK30|CHANGE IN THE STATISTICAL METHOD EMPLOYED DURING INCOMING MATERIAL INSPECTION OF THE HPV CONTROLS OF THE CERVISTA® HPV 16/18 AND REAGENTS IN THE GENFIND® DNA EXTRACTION KIT.
P080014|S009|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR COMPONENTS|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2011|08/02/2011|||OK30|CHANGE IN THE STATISTICAL METHOD EMPLOYED DURING INCOMING MATERIAL INSPECTION OF THE HPV CONTROLS OF THE CERVISTA® HPV HR AND REAGENTS IN THE GENFIND® DNA EXTRACTION KIT.
P040024|S053|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2011|01/26/2012|||APPR|APPROVAL FOR A RELOCATION OF THE CURRENT QUALITY CONTROL LABORATORY (QC-LAB) FOR CHEMICAL, MICROBIOLOGICAL AND RECEIVING INSPECTION ANALYSIS TO A NEW LOCATION WITH Q-MED¿S EXISTING FACILITIES.
P930031|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2011|08/04/2011|||OK30|ALTERNATE VENDOR FOR THE DISTAL TIP COMPONENT OF THE DELIVERY SYSTEM FOR THE DEVICES.
P940019|S026|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (IIIAC) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2011|08/04/2011|||OK30|ALTERNATE VENDOR FOR THE DISTAL TIP COMPONENT OF THE DELIVERY SYSTEM FOR THE DEVICES.
P980033|S019|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2011|08/04/2011|||OK30|ALTERNATE VENDOR FOR THE DISTAL TIP COMPONENT OF THE DELIVERY SYSTEM FOR THE DEVICES.
P020001|S008|NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|NEOVENTA'S STAN S31 FETAL HEART MONITOR|HEO|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2011|08/04/2011|||OK30|ADDITION OF AN INSPECTION TEST FOR THE DEVICE.
P070022|S021|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|07/26/2011|||OK30|CHANGES TO THE MANUFACTURING AND SOLDERING PROCESS OF A COMPONENT OF THE DEVICE.
P010015|S133|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|07/29/2011|||OK30|UPDATE TO PROCESS OPERATION DESCRIPTIONS AND THE IMPLEMENTATION OF NEW TEST MONITORING FOR PACKAGING.
P980016|S311|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P010015|S134|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P010031|S265|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P030036|S035|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD/SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P060039|S029|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P080006|S033|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P090013|S032|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX LEAD & REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P820003|S109|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOABLE COVER & EPG SAFETY CABLE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P830061|S070|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALINE AND VITATRON EXCELLENCE PS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P850089|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P890003|S233|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P900061|S107|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P920015|S081|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P930029|S032|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P930039|S060|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALLINE ACTFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P950024|S034|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P980035|S236|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, RELIA, SENSIA, & VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P980050|S065|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P990001|S093|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+C & VITATRON DA+T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2011|08/04/2011|||OK30|SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.
P100021|S009|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice||N|07/11/2011|08/10/2011|||OK30|SEVERAL MANUFACTURING CHANGES AT THE COMPONENT SUPPLIER.
P030005|S079|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE V172, V173|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/2011|05/01/2012|||APPR|APPROVAL FOR INVIVE MODELS V172, V173 PROGRAMMER 2869 APPLICATION SOFTWARE VERSION 1.07
P070006|S006|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT .TB TEST|OJN|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2011|01/04/2012|||APPR|APPROVAL FOR THE USE OF  T-CELL XTEND REAGENT IN EXTENDING WHOLE BLOOD STORAGE FROM 0-32 HOURS PRIOR TO ASSAYING WITH THE T-SPOT.TB TEST.
P970004|S121|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM|EZW|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2011|08/25/2011|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US INC. IN QUEENSBURY, NEW YORK.
P080025|S013|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM|EZW|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2011|08/25/2011|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US INC. IN QUEENSBURY, NEW YORK.
P100014|S002|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2011|08/10/2011|||OK30|RELOCATION OF THE QUALITY CONTROL LABORATORY TO A NEW LOCATION WITHIN Q-MED AB¿S EXISTING FACILITY.
P070016|S005|WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 TAA ENDOVASCULAR GRAFT|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2011|11/05/2012|||APPR|APPROVAL FOR IN-HOUSE MANUFACTURE OF STENT GRAFT MATERIAL.
P010054|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2011|08/08/2011|||OK30|CHANGE THE IN-PROCESS METHOD TO DETERMINE THE PARTICLE CONCENTRATION OF THE ELECSYS COATED MICROPARTICLES (BEADS).
P100023|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2011|08/11/2011|||OK30|MODIFICATION OF THE SLEEVE CUTTING GUIDE FIXTURE.
P010031|S266|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II||CV|30-Day Notice||N|07/13/2011|08/11/2011|||OK30|CHANGES TO THE FINAL FUNCTIONAL TEST APPLICATION.
P980016|S312|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice||N|07/13/2011|08/11/2011|||OK30|CHANGES TO THE FINAL FUNCTIONAL TEST APPLICATION.
P060033|S066|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTARLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2011|10/25/2011|||APPR|APPROVAL FOR A CHANGE TO THE DRUG SPRAY IN-PROCESS CONTROLS.
P020041|S002|FEMCAP, INC.|14058 MIRA MONTANA DR.||DEL MAR|CA|92014|3455|CAP, CERVICAL, CONTRACEPTIVE|FEM CAP|LLQ|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2011|10/13/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT HELIX MEDICAL, LLC. IN CARPINTERIA, CA93013
P030002|S024|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS|NAA|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/14/2011|09/08/2011|||APPR|APPROVAL TO MODIFY THE LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE +17 TO +27 POWER RANGE FOR THE CRYSTALENS ACCOMMODATING INTRAOCULAR LENS, MODEL AT52AO.
P030022|S019|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2011|08/12/2011|||OK30|CHANGES TO THE SPECIFICATION GOVERNING THE REQUALIFICATION OF THE ETO STERILIZATION PROCESS FOR THE DEVICE.
P000008|S024|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/14/2011|07/29/2011|||APPR|APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR THE RAPIDPORT EZ PORT APPLIER, AN ACCESSORY TO THE LAP-BAND SYSTEM, TO CLARIFY THE PROPER METHOD OF HOLDING THE RAPIDPORT EZ PORT APPLIER AND HOW TO APPLY PRESSURE TO THE PORT APPLIER TO ENSURE THE CORRECT POSITIONING OF THE ACCESS PORT.
P050012|S038|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN AND SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice||N|07/14/2011|08/12/2011|||OK30|REMOVAL OF REDUNDANT DEBURRING STEPS FROM THE CLEANING PROCESSES OF THE NEEDLE AND CANNULA COMPONENTS OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P100023|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/15/2011|02/22/2012|12M-0208|03/07/2012|APPR|APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE).  THE ION STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 4.00 MM IN DIAMETER IN LESIONS <= 34 MM IN LENGTH; OR 2) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRANCH BLOCK WITH SYMPTOMS OF ACUTE MYOCARDIAL INFARCTION LASTING > 20 MINUTES AND > 12 HOURS IN DURATION.
P910023|S268|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2011|08/12/2011|||OK30|CHANGE IN AUTOMATED MANUFACTURING TESTS (ATE) USED AT THE HALF-CAN LEVEL.
P030054|S194|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2011|08/12/2011|||OK30|CHANGE IN AUTOMATED MANUFACTURING TESTS (ATE) USED AT THE HALF-CAN LEVEL.
P980016|S313|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2011|08/12/2011|||OK30|MANUFACTURING SITE CHANGE OF SUPPLIER AND A MINOR CHANGE TO THE WIRE DRAWING PROCESS.
P010031|S267|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2011|08/12/2011|||OK30|MANUFACTURING SITE CHANGE OF SUPPLIER AND A MINOR CHANGE TO THE WIRE DRAWING PROCESS.
P000010|S023|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST|MZP|MI|30-Day Notice||N|07/15/2011|08/09/2011|||OK30|CHANGE TO THE MANUFACTURING BATCH SIZE FOR THE BULK SPECIMEN DILUENT, WHICH IS A COMPONENT OF THE DEVICE.
P000012|S032|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice||N|07/15/2011|08/09/2011|||OK30|CHANGE TO THE MANUFACTURING BATCH SIZE FOR THE BULK SPECIMEN DILUENT, WHICH IS A COMPONENT OF THE DEVICE.
P050019|S008|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|07/15/2011|01/27/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING TO INCLUDE THE POST-APPROVAL STUDY FINDINGS.
P980016|S314|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II, PROTECTA,PROTECTA XT, SECURA AND VIRTUOSO II|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|07/23/2012|||APPR|APPROVAL FOR A CHANGE TO THE BURN-IN TESTING PROCESS FOR TANTALUM CAPACITORS.
P010031|S268|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II. CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|07/23/2012|||APPR|APPROVAL FOR A CHANGE TO THE BURN-IN TESTING PROCESS FOR TANTALUM CAPACITORS.
P070015|S076|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/10/2011|||OK30|CHANGE TO A COMPONENT IN-PROCESS INSPECTION
P020047|S037|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION AND MINVISION CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/10/2011|||OK30|CHANGE TO A COMPONENT IN-PROCESS INSPECTION
P970020|S066|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTILINK ZETA CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/10/2011|||OK30|CHANGE TO A COMPONENT IN-PROCESS INSPECTION
P910023|S269|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|ADDITION OF SECONDARY SUPPLIERS FOR THE THYRISTOR SCR AND THE HIGH VOLTAGE/CURRENT DIODE COMPONENTS.
P030054|S195|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|ADDITION OF SECONDARY SUPPLIERS FOR THE THYRISTOR SCR AND THE HIGH VOLTAGE/CURRENT DIODE COMPONENTS.
P080004|S008|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS  MANUFACTURING|HQL|OP|135 Review Track For 30-Day Notice||N|07/18/2011|06/13/2012|||APPR|APPROVAL TO EXPAND INTRAOCULAR LENS MANUFACTURING.
P980016|S315|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST, INSTRINSIC, MARQUIS, SECURA, VARIOUS MODELS OF MAXIMO, PROTECTA, & VIRTUOSO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|CHANGES TO A MANUFACTURING AID.
P980035|S237|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA, AT500, ENRHYTHM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|CHANGES TO A MANUFACTURING AID.
P010031|S269|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONCERTOI II. CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTS XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|CHANGES TO A MANUFACTURING AID.
P010015|S135|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|CHANGES TO A MANUFACTURING AID.
P090013|S033|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|CHANGES TO A MANUFACTURING AID.
P010032|S040|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON C (IPG) NEUROSTIMULATION SYSTEM|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/18/2011|08/12/2011|||APPR|APPROVAL FOR LABELING CHANGES TO INCLUDE ADDITIONAL INFORMATION REGARDING BATTERY PASSIVATION IN THE EON C IPG DIRECTIONS FOR USE.
P070001|S010|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC -C TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|12/22/2011|||APPR|APPROVAL FOR AN ADDITIONAL PERTHOMETER AND COMPLIMENTING SOFTWARE.
P070026|S003|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/2011|09/16/2011|||APPR|APPROVAL FOR THE ADDITION OF THE TRIO-LOCK BPS (BONE PRESERVING HIP STEM) AND 28 MM CERAMIC FEMORAL HEADS WITH A 12/14 TAPER AND +1.5 MM, +5 MM, AND 8.5 MM OFFSET AS COMPATIBLE MODULAR COMPONENTS TO THE SYSTEM, AND MINOR LABELING CHANGES TO THE DEVICE PACKAGE INSERT AND SURGICAL TECHNIQUE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM  AND IS INDICATED FOR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY TOTAL HIP REPLACEMENT SURGERY FOR REHABILITATION OF HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ANY OF ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS, AVASCULAR NECROSIS, AND POST TRAUMATIC ARTHRITIS.
P960043|S074|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|SUTURE MEDICATED CLOSURE SYSTEMS, PERCUTANEOUS VASCULAR SURGICAL SYSTEMS AND ASSOCIATED ACCESORIES|MGB|CV|30-Day Notice||N|07/18/2011|08/10/2011|||OK30|CHANGE IN BET LOCATION AND TECHNIQUE.
P050007|S029|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|VASCULAR CLOSURE SYSTEMS|MGB|CV|30-Day Notice||N|07/18/2011|08/10/2011|||OK30|CHANGE IN BET LOCATION AND TECHNIQUE.
P830055|S121|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/18/2011|02/09/2012|||APPR|APPROVAL FOR THE ADDITION OF MOBILE BEARING ATTUNE CR (CRUCIATE RETAINING) RP (ROTATING PLATFORM) TIBIAL BASES AND TIBIAL INSERTS FOR USE WITH PREVIOUSLY CLEARED FEMORAL AND PATELLAR COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATTUNE ROTATING PLATFORM (RP) TOTAL KNEE SYSTEM AND IS INDICATED FOR USE IN TOTAL KNEEREPLACEMENT IN PATIENTS WITH A SEVERELY PAINFUL AND/OR SEVERELY DISABLED JOINT RESULTING FROM OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, OR A FAILED PREVIOUS IMPLANT.
P910023|S270|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/2011|03/09/2012|||APPR|APPROVAL FOR THE ADDITION OF THE CORVUE THORACIC IMPEDANCE MONITORING FEATURE IN THE UNIFY, FORTIFY AND QUADRA FAMILY OF DEVICES.
P030054|S196|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF FAMILY|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/2011|03/09/2012|||APPR|APPROVAL FOR THE ADDITION OF THE CORVUE THORACIC IMPEDANCE MONITORING FEATURE IN THE UNIFY, FORTIFY AND QUADRA FAMILY OF DEVICES.
P980016|S316|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE; ENTRUST; INTRINSIC; MARQUIS; VARIOUS MODELS OF MAXIMO, VIRTUOSO, & PROTECTA; SECURA|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P010015|S136|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|SYNCRA CRT-P, CONSULTA CRT-P, INSYNC III, ATTAIN|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P010031|S270|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONCERTO II, CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P030036|S036|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD/SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P060039|S030|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P080006|S034|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P090013|S034|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI, CAPSURE FIX LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P820003|S110|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOABLE COVER & EPG SAFETY CABLE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P830061|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALINE, & VITATRON EXCELLENCE +/PS+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P850089|S083|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, CAPSURE Z NOVUS, VARIOUS MODELS OF VITATRON|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P900061|S108|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P920015|S082|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P930029|S033|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P930039|S061|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALLINE ACTFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P950024|S035|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P980035|S238|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES, ADAPTA, ADVISA, ENRHYTHM, RELIA, SENSIA, SIGMA, VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P980050|S066|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P990001|S094|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+C & VITATRON DA+T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P890003|S234|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD, CAPSURE MODEL LEAD, PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2011|08/15/2011|||OK30|MODIFICATION TO EQUIPMENT CALIBRATION CONTROL.
P840001|S193|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2011|08/17/2011|||OK30|IMPLEMENT A CHANGE IN A MANUFACTURING AID MATERIAL, AS WELL AS A CHANGE IN COMPONENT SPECIFICATION AND INSPECTION PROCESS AT A COMPONENT SUPPLIER.
P860004|S155|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2011|08/17/2011|||OK30|IMPLEMENT A CHANGE IN A MANUFACTURING AID MATERIAL, AS WELL AS A CHANGE IN COMPONENT SPECIFICATION AND INSPECTION PROCESS AT A COMPONENT SUPPLIER.
P960009|S123|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2011|08/17/2011|||OK30|IMPLEMENT A CHANGE IN A MANUFACTURING AID MATERIAL, AS WELL AS A CHANGE IN COMPONENT SPECIFICATION AND INSPECTION PROCESS AT A COMPONENT SUPPLIER.
P970004|S122|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2011|08/17/2011|||OK30|IMPLEMENT A CHANGE IN A MANUFACTURING AID MATERIAL, AS WELL AS A CHANGE IN COMPONENT SPECIFICATION AND INSPECTION PROCESS AT A COMPONENT SUPPLIER.
P080025|S014|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2011|08/17/2011|||OK30|IMPLEMENT A CHANGE IN A MANUFACTURING AID MATERIAL, AS WELL AS A CHANGE IN COMPONENT SPECIFICATION AND INSPECTION PROCESS AT A COMPONENT SUPPLIER.
P940016|S014|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/2011|01/13/2012|||APPR|APPROVAL FOR A CHANGE IN THE POTTING RESIN USED TO ANCHOR THE MEMBRANES OF THE HEPARIN ADSORBER AND THE PLASMAFILTER HAEMOSELECT COMPONENTS OF THE SYSTEM.
P070001|S011|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC -C TOTAL DISC REPLACEMENT|MJO|OR|30-Day Notice||N|07/19/2011|08/18/2011|||OK30|CHANGE TO THE LOCATION OF THE TRAY MANUFACTURING AND RAW MATERIAL SUPPLIER.
P070016|S006|WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 TAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/19/2011|12/06/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P080013|S007|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/2011|08/18/2011|||APPR|APPROVAL FOR A MODIFICATION TO THE INSTRUCTIONS FOR USE TO INSTRUCT THE SURGEON IN THE BEST PRACTICES IN APPLYING THE SEALANT.
P020025|S030|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|MAESTRO 3000 CARDIAC ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2011|08/18/2011|||OK30|EIGHT (8 ) TEST APPLICATION CHANGES TO THE FINAL FUNCTIONAL TEST RELEASE.
P880047|S017|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2011|08/18/2011|||OK30|ADDITION OF A NEW BAND SEALER.
P980016|S317|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II, PROTECTA, PROTECTA XT, SECURA VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2011|08/19/2011|||OK30|CHANGE THE BUTTED CONTACT (BTC) ETCH TIME.
P010015|S137|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|SYNCRA CRT-P, CONSULTA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2011|08/19/2011|||OK30|CHANGE THE BUTTED CONTACT (BTC) ETCH TIME.
P010031|S271|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2011|08/19/2011|||OK30|CHANGE THE BUTTED CONTACT (BTC) ETCH TIME.
P090013|S035|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2011|08/19/2011|||OK30|CHANGE THE BUTTED CONTACT (BTC) ETCH TIME.
P980035|S239|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2011|08/19/2011|||OK30|CHANGE THE BUTTED CONTACT (BTC) ETCH TIME.
P980016|S318|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA (D334TRG, D334VRG), PROTECTA XT (D314DRG, D314VRG)|LWS|CV|30-Day Notice||N|07/20/2011|08/18/2011|||OK30|CHANGES TO THE RADIO FREQUENCY TESTING OF HYBRIDS.
P010031|S272|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||(D334TRG), PROTECTA XT (D314TRG)||CV|30-Day Notice||N|07/20/2011|08/18/2011|||OK30|CHANGES TO THE RADIO FREQUENCY TESTING OF HYBRIDS.
P040024|S054|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|PERLANE L INJACTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2011|08/18/2011|||OK30|NEW FILL VOLUME FOR THE DEVICE AND A NEW NEEDLE SIZE TO BE USED WITH THE NEW FILL VOLUME.
P010013|S039|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPENDANCE CONROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2011|08/18/2011|||OK30|IMPLEMENTATION OF A NEW DE-KNITTING MACHINE.
P960043|S075|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE AT AND PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/25/2011|09/23/2011|||APPR|APPROVAL FOR AN ALTERNATE MATERIAL FOR MANUFACTURING THE TENSIONER COMPONENT.
P840001|S194|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD|LGW|NE|30-Day Notice||N|07/22/2011|08/17/2011|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P970004|S123|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice||N|07/22/2011|08/17/2011|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P990034|S024|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK|LKK|HO|30-Day Notice||N|07/22/2011|08/17/2011|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P080025|S015|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice||N|07/22/2011|08/17/2011|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P060038|S010|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2011|12/12/2011|||APPR|APPROVAL FOR IMPLEMENTATION OF AN IN-HOUSE DISTILLATION PROCESS TO PRODUCE EM GRADE LUTARALDEHYDE TO BE USED IN THE MANUFACTURE OF THE SUBJECT DEVICE.
P000006|S025|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice||N|07/22/2011|08/18/2011|||OK30|ADDITION OF ANOTHER SUPPLIER OF TUBING.
P070015|S077|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V  AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2011|10/23/2012|||APPR|APPROVAL TO USE EVEROLIMUS, THE ACTIVE PHARMACEUTICAL INGREDIENT (API) IN THE DEVICES, FOLLOWING A CHANGE IN THE MANUFACTURING PROCESS IMPLEMENT BY NOVARTIS, THE API MANUFACTURER.
P960013|S066|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL STS 1988TC AND 2088TC|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2011|11/01/2011|||APPR|APPROVAL FOR THREE ADDITIONAL LEAD LENGTHS OF 65, 85 AND 100 CM IN THE TENDRIL STS PACEMAKER LEADS.
P860004|S156|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER|LKK|HO|30-Day Notice||N|07/22/2011|08/17/2011|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P960009|S124|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS|MHY|NE|30-Day Notice||N|07/22/2011|08/17/2011|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P000032|S036|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2011|10/12/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOPERSURGICAL, INC. IN TRUMBULL, CONNETICUT.
P970004|S124|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEMS|EZW|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/25/2011|04/10/2012|||APPR|APPROVAL FOR UPDATING THE LABELING TO ALLOW PARTICULAR TYPES OF MRI SCANS TO BE PERFORMED WHILE THE  DEVICES ARE IMPLANTED AND FOR ASSOCIATED CHANGES IN THE PRODUCT SPECIFICATION OF MODEL 3023 INTERSTIM NEUROSTIMULATOR.
P080025|S016|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEMS|EZW|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/25/2011|04/10/2012|||APPR|APPROVAL FOR UPDATING THE LABELING TO ALLOW PARTICULAR TYPES OF MRI SCANS TO BE PERFORMED WHILE THE DEVICES ARE IMPLANTED AND FOR ASSOCIATED CHANGES IN THE PRODUCT SPECIFICATION OF MODEL 3023 INTERSTIM NEUROSTIMULATOR.
P080025|S017|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2011|08/24/2011|||OK30|CHANGES TO MANUFACTURING EQUIPMENT AND IN PROCESS INSPECTIONAL METHODS.
P040047|S021|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2011|05/17/2012|||APPR|APPROVAL TO REPLACE THE PIN GAUGE TEST WITH A PLUNGER CONTACT TEST AND TO REPLACE THE MANUAL WAY OF MEASURING THE LUER END OF THE SYRINGE BARREL WITH A CALIBRATED LUER GAUGE.
P030054|S197|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF / ATLAS + HF FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2011|09/08/2011|||APPR|APPROVAL FOR CHANGES TO THE CONTROLLER INTEGRATED CIRCUITS FOR THE DEVICE.
P910023|S271|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2011|09/08/2011|||APPR|APPROVAL FOR CHANGES TO THE CONTROLLER INTEGRATED CIRCUITS FOR THE DEVICE.
P090022|S005|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/26/2011|09/22/2011|||APPR|APPROVAL TO AMEND THE APPROVED LABELING TO ALLOW FOR THE USE OF THE ASICO SOFTIP INJECTION SYSTEM, MODEL NUMBER AS-9300 WITH THE SOFTEC HD, SOFTEC I AND SOFTEC HD PS INTRAOCULAR LENSES (IOLS).
P070015|S078|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE NANO AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2011|08/25/2011|||OK30|FOUR MANUFACTURING PROCESS CHANGES, WHICH HAVE BEEN PREVIOUSLY APPROVED FOR XIENCE V.  THE CHANGES INCLUDED: (A) REMOVAL OF INITIAL CLEAN AND PLASMA TREATMENT; (B) REMOVAL OF DRUG FINAL WEIGH; (C) MODIFIED CLEAN ROOM GOWNING; AND (D) MODIFICATIONS TO THE SPRAY COATING PROCESS.
P970031|S034|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORIC ROOT BIOPROSTHESIS MODELS 995, 995CS AND 995MS|LWR|CV|30-Day Notice||N|07/28/2011|08/25/2011|||OK30|ADDITION OF A GLUTARALDEHYDE SUPPLIER.
P990064|S039|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS MODELS 305 AND 310|LWR|CV|30-Day Notice||N|07/28/2011|08/25/2011|||OK30|ADDITION OF A GLUTARALDEHYDE SUPPLIER.
P980043|S032|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice||N|07/28/2011|08/25/2011|||OK30|ADDITION OF A GLUTARALDEHYDE SUPPLIER.
P790007|S030|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK I LOW POROSITY AND MIDIFIED ORIFICE VALVED CONDUIT MODEL 105|LWR|CV|30-Day Notice||N|07/28/2011|08/25/2011|||OK30|ADDITION OF A GLUTARALDEHYDE SUPPLIER.
P090022|S006|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD INTRAOCULAR LENS|HQL|OP|30-Day Notice||N|07/28/2011|08/25/2011|||OK30|USE OF AN ALTERNATIVE SUPPLIER OF THE SILICONE VIAL STOPPER.
P040021|S019|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|EPIC VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2011|12/19/2011|||APPR|APPROVAL FOR CHANGES IN THE EXPOSURE TIMES TO STERILANT AND MANUFACTURING PROCESS SOLUTIONS.
P930038|S068|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/09/2011|10/18/2011|||APPR|APPROVAL TO INCREASE THE DENATURATION TEMPERATURE RANGE TO 42.41 ¿ 53.3¿C.
P100013|S001|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2011|08/25/2011|||OK30|CHANGE IN THE PROCESSING OF A COMPONENT OF THE DEVICE.
P900061|S109|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|OVAL PATCH LEAD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2011|12/23/2011|||APPR|APPROVAL FOR THE RELOCATION OF A CONTROLLED ENVIRONMENT AREA (CEA).
P000010|S024|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST|MZP|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/2011|01/11/2012|||APPR|APPROVAL FOR A CHANGE TO THE TEST METHOD FOR DETERMINATION OF DITHIOTHREITOL IN BULK AND VIALED LYSIS REAGENTS.
P000012|S033|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST V2.0, COBAS AMPLIPREP/ COBAS AMPLICOR HCV TEST, V2.0|MZP|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/2011|01/11/2012|||APPR|APPROVAL FOR A CHANGE TO THE TEST METHOD FOR DETERMINATION OF DITHIOTHREITOL IN BULK AND VIALED LYSIS REAGENTS.
P900056|S108|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR TOTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2011|08/25/2011|||OK30|MODIFICATION AND REARRANGEMENT OF THE MANUFACTURING PROCESS FOR EFFICIENCY.
P010012|S270|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MULTICETER AUTOMATIC DEFIBRILLATOR IMPLANT ATION YTRIAL WITH CARDIAC RESYNCHRONIZATION THERAPY|LWP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/29/2011|09/27/2011|||APPR|APPROVAL FOR POST- APPROVAL STUDY PROTOCOL.
P860004|S157|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER|LKK|HO|Special (Immediate Track)||N|07/29/2011|08/26/2011|||APPR|APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION.  THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES.
P960009|S125|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS|MHY|NE|Special (Immediate Track)||N|07/29/2011|08/26/2011|||APPR|APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION.  THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES.
P840001|S195|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD|LGW|NE|Special (Immediate Track)||N|07/29/2011|08/26/2011|||APPR|APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION.  THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES.
P970004|S125|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEMS|EZW|GU|Special (Immediate Track)||N|07/29/2011|08/26/2011|||APPR|APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER.  THESE CHANGES INCLUDE THE ADDITION OR PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION.  THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES.
P080025|S018|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM|EZW|GU|Special (Immediate Track)||N|07/29/2011|08/26/2011|||APPR|APPROVAL FOR LABELING CHANGES TO THE MANUAL FOR THE MODEL 8840 NVISION CLINICIAN PROGRAMMER.  THESE CHANGES INCLUDE THE ADDITION OR PRECAUTIONS RELATED TO MODIFICATION OF THE DEVICE, THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION, AND THE EFFECTS OF BATTERY CORROSION.  THE CHANGES ALSO INCLUDE UPDATES TO EXISTING PRECAUTIONARY LANGUAGE TO MAINTAIN CONSISTENCY WITH OTHER MEDTRONIC LABELING FOR EXTERNAL PROGRAMMING DEVICES.
P940035|S007|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|ALERE NMP22  URINE COLLECTION  KIT|NAH|IM|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|07/27/2011|01/20/2012|||APPR|APPROVAL FOR THE NMP22 TEST KIT AND NMP22 URINE COLLECTION KIT UNDER ALERE SCARBOROUGH, INCS BRAND NAME.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER: TRADE NAME ALERE NMP22 TEST WITH THE FOLLOWING INTENDED USE: ALERE NMP22 TEST IS AN ENZYME IMMUNOASSAY (EIA) FOR THE IN VITRO QUANTITATIVE DETERMINATION OF THE NUCLEAR MITOTIC APPARATUS PROTEIN (NUMA) IN STABILIZED VOIDED URINE.  THE ALERE NMP22 TEST KIT IS INDICATED AS AN AID 1) IN THE DIAGNOSIS OF PERSONS WITH SYMPTOMS OR RISK FACTORS FOR TRANSITIONAL CELL CANCER (TCC) OF THE BLADDER (CUT-OFF >= 7.5 U/ML) IN CONJUNCTION WITH, AND NOT IN LIEU OF, CURRENT STANDARD DIAGNOSTIC PROCEDURES, AND 2) IN MANAGEMENT OF PATIENTS OF TRANSITIONAL CELL CARCINOMA OF THE BLADDER, AFTER SURGICAL TREATMENT TO IDENTIFY THOSE PATIENTS WITH OCCULT OR RAPIDLY RECURRING TCC (CUT-OFF > 10 U/ML).  TRADE NAME ALERE NMP22 URINE COLLECTION KIT, WITH THE FOLLOWING INTENDED USE:  THE ALERE NMP22 URINE COLLECTION KIT IS INTENDED FOR THE COLLECTION, STABILIZATION, AND TRANSPORT OF HUMAN URINE WHICH WILL BE TESTED USING THE ALERE NMP22 TEST KIT.
P890064|S027|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST|MAQ|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2011|05/21/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN INSTRUMENTS AG IN HOMBRECHTIKON, SWITZERLAND.
P900033|S020|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN, DERMAL REGENERATION TEMPLATE|MDD|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2011|05/04/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES IN ANASCO, PUERTO RICO.
P060033|S067|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/2011|09/30/2011|||APPR|APPROVAL FOR A SHELF LIFE EXTENSION FROM TWO YEARS TO THREE YEARS FOR THE DEVICE.
P050049|S008|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM HBSAG|LOM|MI|135 Review Track For 30-Day Notice||N|08/01/2011|11/14/2011|||APPR|APPROVAL FOR A CHANGE TO A SUPPLIER FOR AN INCOMING RAW MATERIAL, NONFAT DRY MILK (NFDM) THAT IS A COMPONENT OF THE AXSYM HBSAG CONJUGATE DILUENT IN THE AXSYM HBSAG REAGENT PACK IN THE AXSYM HBSAG ASSAY.
P050047|S019|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPKANTS|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/2011|09/23/2011|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM 12 MONTHS TO 24 MONTHS FOR THE 0.8ML SYRINGE (0.4ML AND 0.8ML VOLUMES); AN INCREASE IN THE MONOETHYLGLYCINEXYIDIDE (MEGX) IMPURITY SPECIFICATION FROM <= 0.3% W/W OF LABEL STRENGTH TO <= 2.0% W/W OF LABEL STRENGTH; AND AN INCREASE IN TOTAL IMPURITIES SPECIFICATION FROM <= 0.5% W/W OF LABEL STRENGTH TO <= 2.5% W/W OF LABEL STRENGTH.
P980046|S008|HOME ACCESS HEALTH CORP.|2401 W. HASSELL|SUITE 1510|HOFFMAN ESTATES|IL|60195|5200|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|HOME ACCESS HEPATITIS C CHECK TEST SYSTEM|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2011|08/31/2011|||OK30|NEW SUPPLIER FOR THE BARRIER POUCH COMPONENT OF THE DEVICE.
P810031|S040|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES|LZP|OP|30-Day Notice||N|08/01/2011|08/31/2011|||OK30|IMPLEMENTATION OF A NEW PURE STEAM GENERATOR.
P100018|S003|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|Special (Immediate Track)||N|08/01/2011|08/30/2011|||APPR|APPROVAL FOR ADDING A WARNING ABOUT ALLERGIES TO METALS USED IN THE DEVICE AND CLARIFYING YOUR INSTRUCTIONS FOR UESE.
P970003|S133|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2011|08/31/2011|||OK30|CHANGE TO ADD ADDITIONAL TESTING FOR THE FLASH MEMORY CARDS.
P000027|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA (FPSA) TEST SYSTEM|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/2011|02/24/2012|||APPR|APPROVAL FOR EXTENSION OF THE ELECSYS FREE PSA (FPSA) TEST SYSTEM ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER.
P050044|S019|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|CELLPAKER PLASMA COLLECTION DEVICE|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/2011|01/31/2012|||APPR|APPROVAL FOR A DESIGN CHANGE (REMOVAL OF THE METERING KNOB) TO THE CELLPAKER COMPONENT OF THE VITAGEL SURGICAL HEMOSTAT SYSTEM, INTRODUCTION OF A NEW CONTRACT MANUFACTURER LOCATED AT TEGRA MEDICAL IN DARTHMOUTH, MASSACHUSETTS, A CHANGE TO THE PACKAGING MATERIALS AND STERILIZATION METHODS FOR THE SYSTEM COMPONENT, AND THE RE-BRANDING OF THE CELLPAKER COMPONENT AS VITAPREP PLASMA SEPARATOR.
P070015|S079|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2011|09/01/2011|||OK30|IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR PROCESS MONITORING.
P970020|S067|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2011|09/01/2011|||OK30|IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR PROCESS MONITORING.
P020047|S038|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK FAMILY OF CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2011|09/01/2011|||OK30|IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR PROCESS MONITORING.
P040038|S022|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CARTOID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2011|09/01/2011|||OK30|IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR PROCESS MONITORING.
P040012|S041|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK SELF-EXPANDING STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2011|09/01/2011|||OK30|IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR PROCESS MONITORING.
P040038|S023|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CARTOID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2011|09/02/2011|||OK30|CHANGE OF SUPPLIER AND MANUFACTURING PROCESS FOR A COMPONENT IN THE HANDLE OF THE DELIVERY SYSTEM.
P950029|S061|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT PACEMAKER IMPLANTABLE MEDICAL DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2011|08/29/2011|||OK30|CHANGE TO THE REFLOW SOLDERING PROFILE AND AN ALTERNATE TOOLING USED FOR THE PASSING OVEN.
P910077|S117|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND VENTAK MINI AUTOMATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ACID) SYSTEMS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2011|09/01/2011|||OK30|CHANGE TO A CONTRACT MANUFACTURERS SOLDER STENCIL AND PICK-AND-PLACE EQUIPMENT.
P970021|S036|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|08/03/2011|09/23/2011|||APPR|APPROVAL FOR A CHANGE IN THE MATERIAL USED TO FORM THE INSULATION LAYER OF THE THERMOCOUPLE WIRES USED WITHIN THE BALLOON OF THE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM.
P950029|S062|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|ALTERNATE LASER SOURCE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2011|09/01/2011|||OK30|MODIFY THE PRE-CONDITIONING CYCLE BEFORE LASER WELDING AND THE USE OF AN ALTERNATE LASER SOURCE.
P010033|S019|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON -TB GOLD|NCD|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/04/2011|10/20/2011|||APPR|APPROVAL FOR CHANGES TO THE LABELING: INSTRUCTIONS FOR USE SECTION, SPECIMEN COLLECTION AND HANDLING SECTION, AND ABBREVIATED TEST PROCEDURE SECTION FOR USE OF THE QUANTIFERON® BLOOD COLLECTION TUBES.
P000025|S055|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+  COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2011|09/02/2011|||OK30|ADDITIONAL SUPPLIER FOR THE STERILE BARRIER SYSTEM.
P080025|S019|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2011|08/30/2011|||OK30|ADDITION OF A NEW MANUFACTURING MOLD AND A NEW COMPONENT SUPPLIER
P100023|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2011|09/07/2011|||OK30|CHANGE TO YOUR FIRM¿S DELIVERY CATHETER BONDING PROCESS.
P950032|S064|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2011|09/22/2011|||APPR|APPROVAL FOR THE INTRODUCTION OF HUMAN DERMAL FIBROBLAST CELL STRAIN (HDF 072) INTO THE MANUFACTURE OF APLIGRAF.
P900060|S046|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2011|09/02/2011|||OK30|CHANGE IN THE TUMBLING EQUIPMENT AND THE CORRESPONDING TUMBLING PROCESS.
P090013|S037|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PACKAGED DIODES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2011|09/01/2011|||OK30|ELIMINATION OF A BURN-IN PROCESS FOR SOME ELECTRICAL COMPONENTS.
P940015|S022|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC AND SYNVISC-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2011|10/07/2011|||OK30|ADDITION OF A SYRINGE ASSEMBLY MACHINE TO THE PACKAGING DEPARTMENT.
P970051|S085|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2011|10/04/2011|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE EARHOOK ATTACHMENT TO THE DEVICE, WHICH INVOLVES A CHANGE IN MATERIAL.
P010007|S006|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AFP IMMULITE ASSAY|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/07/2011|||OK30|THE CHANGE IS TO IMPLEMENT USE OF A FULLY AUTOMATED FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE.  THE CURRENT METHOD OF FILLING AND PACKAGING THE SUBSTRATE IS BY USE OF A SEMI-AUTOMATED LINE.  FULL AUTOMATION OF THE LINE ELIMINATES REPETITIVE ACTIONS THAT ARE PERFORMED MANUALLY.
P930027|S012|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|PSA IMMULITE ASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/07/2011|||OK30|THE CHANGE IS TO IMPLEMENT USE OF A FULLY AUTOMATED FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE.  THE CURRENT METHOD OF FILLING AND PACKAGING THE SUBSTRATE IS BY USE OF A SEMI-AUTOMATED LINE.  FULL AUTOMATION OF THE LINE ELIMINATES REPETITIVE ACTIONS THAT ARE PERFORMED MANUALLY.
P060005|S005|SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED|GLYN RHONWY. LLANBERIS|CAERNARFON|GWYNEDD, LL55||4EL||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|FPSA IMMULITE ASSAY|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/07/2011|||OK30|THE CHANGE IS TO IMPLEMENT USE OF A FULLY AUTOMATED FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUSMINESCENT SUBSTRATE.  THE CURRENT METHOD OF FILLING AND PACKAGING THE SUBSTRATE IS BY USE OF A SEMI-AUTOMATED LINE.  FULL AUTOMATION OF THE LINE ELIMINATES REPETITIVE ACTIONS THAT ARE PERFORMED MANUALLY.
P010051|S009|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBC IMMULITE ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/02/2011|||OK30|FULL AUTOMATION OF THE FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE REAGENT, ACCESSORY USED WITH ALL THE IMMULITE ASSAYS.
P010053|S008|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBCM IMMULITE ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/02/2011|||OK30|FULL AUTOMATION OF THE FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE REAGENT, ACCESSORY USED WITH ALL THE IMMULITE ASSAYS.
P010050|S013|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|HBSAG IMMULITE ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/02/2011|||OK30|FULL AUTOMATION OF THE FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE REAGENT, ACCESSORY USED WITH ALL THE IMMULITE ASSAYS.
P010052|S009|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBS IMMULITE ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/02/2011|||OK30|FULL AUTOMATION OF THE FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE REAGENT, ACCESSORY USED WITH ALL THE IMMULITE ASSAYS.
P880086|S208|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2011|09/08/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.
P030035|S087|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2011|09/08/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.
P880006|S073|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|SENSOLOG/DIALOG/REGENCY FAMILY OF CRT-PS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2011|09/08/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.
P970013|S042|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MICRONY FAMILY OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2011|09/08/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.
P910023|S272|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable pulse generator, pacemaker (non-CRT)|CADENCE/CURRENT FAMILY OF ICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2011|09/08/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.
P030054|S198|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable pulse generator, pacemaker (non-CRT)|EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2011|09/08/2011|||APPR|APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.
P820003|S111|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|5433 PATIENT CABLE PROXIMAL CONNECTOR AND MATERIAL|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/07/2011|||OK30|CHANGES TO THE PATIENT CABLE PROXIMAL CONNECTOR, AND THE SOLDER AND REFLUX MANUFACTURING MATERIALS.
P090006|S007|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/07/2011|||OK30|REDUCTION IN PYROGEN TESTING SAMPLE SIZE.
P100029|S007|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2011|09/07/2011|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR STENT TUBING MATERIAL.
P030009|S058|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/08/2011|09/07/2011|||APPR|APPROVAL TO MODIFY THE MAXIMUM STENT INNER DIAMETER (MSID) FOR THE MEDIUM VESSEL STENT SIZES (3.0 MM TO 4.0 MM DIAMETERS) FROM 4.75 MM TO 5.0 MM.
P080025|S020|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE THERAPY SYSTEM|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2011|09/06/2011|||APPR|APPROVAL FOR MINOR DESIGN, MANUFACTURING, AND LABELING CHANGES TO THE MODEL 3625 EXTERNAL TEST STIMULATOR IN ORDER TO ESTABLISH COMPLIANCE WITH FUNCTIONAL REQUIREMENTS IN THE HARMONIZED STANDARDS IEC (INTERNATIONAL ELECTROTECHNICAL COMMISSION) 60601-1 AND IEC 60601-1-2.
P040037|S036|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2011|10/27/2011|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF THE DRUG COATING COMPONENT OF THE DEVICE.
P790002|S027|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIO OSTEOGEN SYSTEM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2011|09/07/2011|||OK30|REPLACEMENT OF AN ANALOG ELECTRICAL ISOLATION TESTER WITH A DIGITAL ELECTRONIC ISOLATION TESTER, AND ADDITION OF A MANUAL HAND-SOLDERING PROCESS AS AN ALTERNATIVE TO THE EXISTING AUTOMATIC SOLDERING PROCESS.
P080011|S005|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON) SOFT CONTACT LENS|LPM|OP|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|08/11/2011|12/20/2011|||APPR|APPROVAL TO ADD THE PRIVATE LABEL NAME AQUATECH PLUS PREMIUM TO THE LIST OF APPROVED NAMES FOR THE DEVICE.
P970003|S134|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2011|09/09/2011|||OK30|ADDITIONAL SPOT WELDING MACHINE.
P930039|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX MODELS 4076, 5076|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2011|09/07/2011|||OK30|REPLACEMENT OF A LASER WELDER AND PROCESS PARAMETER UPDATES.
P090013|S038|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MODEL 5086MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2011|09/07/2011|||OK30|REPLACEMENT OF A LASER WELDER AND PROCESS PARAMETER UPDATES.
P000029|S070|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2011|09/09/2011|||OK30|COMPOSITION OF THE BIOLOGICAL INDICATOR.
P990056|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA (TPSA) TEST SYSTEM|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/01/2011|02/24/2012|||APPR|APPROVAL FOR EXTENSION OF THE ELECSYS TOTAL PSA (TPSA) TEST SYSTEM ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER.
P070027|S031|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ENDOLUMINALOCCLUDER SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2011|09/07/2011|||OK30|CHANGE TO THE FIRM¿S STERILIZATION PROCESS.
P100014|S003|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2011|09/09/2011|||OK30|CHANGE IN COMPOSITION OF THE BIOLOGICAL INDICATOR.
P980018|S014|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2011|09/09/2011|||OK30|AUTOMATED MANUFACTURING PROCESS OF CONTROL CELLS FOR THE CONTROL SLIDES.
N12159|S028|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice||N|08/15/2011|09/15/2011|||OK30|ADDITION OF NEW PACKAGING EQUIPMENT.
N18033|S060|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2011|09/14/2011|||OK30|CHANGE TO THE FLOW AND TEMPERATURE MONITORING SYSTEM FOR INJECTION MOLDING.
P050012|S039|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN AND SEVEN PLUS SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2011|07/24/2012|||APPR|APPROVAL FOR A PROPOSED CHANGE TO REMOVE REDUNDANT DESTRUCTIVE TESTING FOR BOND STRENGTH OF THREE APPLICATOR COMPONENTS (CANNULA CARRIER, PUSH ROD CARRIER, AND SENSOR NEEDLE CARRIER) OF THE DEVICES.
P080025|S021|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION THERAPY FOR BOWEL CONTROL|EZW|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/15/2011|10/11/2011|||APPR|APPROVAL OF POST-APPROVAL PROTOCOL.
P050012|S041|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN AND SEVEN PLUS SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2011|09/30/2011|||APPR|APPROVAL FOR A MANUFACTURING CHANGE TO IMPLEMENT A NEW SPRAY FIXTURE IN DEXCOM¿S SENSOR MEMBRANE SPRAY SYSTEM.
P010050|S014|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2011|09/13/2011|||OK30|IMPLEMENTATION OF AN INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
P010051|S010|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2011|09/13/2011|||OK30|IMPLEMENTATION OF AN INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
P010052|S010|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2011|09/13/2011|||OK30|IMPLEMENTATION OF AN INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
P010053|S009|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2011|09/13/2011|||OK30|IMPLEMENTATION OF AN INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
P060005|S006|SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED|GLYN RHONWY. LLANBERIS|CAERNARFON|GWYNEDD, LL55||4EL||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|IMMULITE/IMMULITE 1000 FREE PSA AND IMMULITE 2000 FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2011|09/12/2011|||OK30|PERMANENT IMPLEMENTATION OF THE INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
P930027|S013|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2011|09/12/2011|||OK30|PERMANENT IMPLEMENTATION OF THE INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
P010007|S007|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2011|09/12/2011|||OK30|PERMANENT IMPLEMENTATION OF THE INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING.
P850079|S050|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|CLEARSOFT (METHAFILCON A) SOFT COTACT LENS|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/16/2011|12/20/2011|||APPR|APPROVAL TO ADD THE PRIVATE LABEL NAME AQUATECH PREMIUM TO THE LIST OF APPROVED NAME FOR THE DEVICE.
P900056|S109|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice||N|08/16/2011|09/15/2011|||OK30|ALTERNATE SUPPLIER OF COATING MATERIAL FOR THE ROTABLATOR CONSOLE.
P090018|S012|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2011|09/21/2011|||OK30|APPROVAL FOR CHANGING FROM THE USE OF FETAL BOVINE SERUM TO THE USE OF BOVINE CALF SERUM AS A MEDIA SUPPLEMENT FOR EXPANDING CELLS IN EXPANDED SURFACE ROLLER BOTTLES, I.E., THE CELL EXPANSION PROCESS.
P990012|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|11/16/2011|||APPR|APPROVAL FOR THE IN-PROCESS TEST METHOD FOR DETERMINATION OF PARTICLE CONCENTRATION OF ELECSYS COATED MICROPARTICLE (BEADS).
P090007|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|11/16/2011|||APPR|APPROVAL FOR THE IN-PROCESS TEST METHOD FOR DETERMINATION OF PARTICLE CONCENTRATION OF ELECSYS COATED MICROPARTICLE (BEADS).
P090008|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI -HCV IMMUNOASSAY ON COBAS E 601|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|11/16/2011|||APPR|APPROVAL FOR THE IN-PROCESS TEST METHOD FOR DETERMINATION OF PARTICLE CONCENTRATION OF ELECSYS COATED MICROPARTICLE (BEADS).
P090009|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYSTICS E170|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|11/16/2011|||APPR|APPROVAL FOR THE IN-PROCESS TEST METHOD FOR DETERMINATION OF PARTICLE CONCENTRATION OF ELECSYS COATED MICROPARTICLE (BEADS).
P100031|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYSTICS E170|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|11/16/2011|||APPR|APPROVAL FOR THE IN-PROCESS TEST METHOD FOR DETERMINATION OF PARTICLE CONCENTRATION OF ELECSYS COATED MICROPARTICLE (BEADS).
P100032|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|11/16/2011|||APPR|APPROVAL FOR THE IN-PROCESS TEST METHOD FOR DETERMINATION OF PARTICLE CONCENTRATION OF ELECSYS COATED MICROPARTICLE (BEADS).
P810002|S078|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2011|11/01/2012|||APPR|APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE (IFU), ST. JUDE MEDICAL (SJM) INTERNET, AND ANY OTHER APPLICABLE DEVICE LABELING TO INCLUDE THE NEW MAGNETIC RESONANCE IMAGING (MRI) TESTING INFORMATION TO ENHANCE THE SAFE USE OF THE DEVICE WHEN UNDERGOING MRI.
P040021|S020|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||HEART-VALVE, MECHANICAL|EPIC VALVE|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2011|11/01/2012|||APPR|APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE (IFU), ST. JUDE MEDICAL (SJM) INTERNET, AND ANY OTHER APPLICABLE DEVICE LABELING TO INCLUDE THE NEW MAGNETIC RESONANCE IMAGING (MRI) TESTING INFORMATION TO ENHANCE THE SAFE USE OF THE DEVICE WHEN UNDERGOING MRI.
P100029|S008|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||HEART-VALVE, MECHANICAL|TRIFECA HEART VALVE|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2011|11/01/2012|||APPR|APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE (IFU), ST. JUDE MEDICAL (SJM) INTERNET, AND ANY OTHER APPLICABLE DEVICE LABELING TO INCLUDE THE NEW MAGNETIC RESONANCE IMAGING (MRI) TESTING INFORMATION TO ENHANCE THE SAFE USE OF THE DEVICE WHEN UNDERGOING MRI.
P970031|S035|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|09/14/2011|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P990064|S040|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|09/14/2011|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P980043|S033|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PROCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|09/14/2011|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P790007|S031|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|09/14/2011|||OK30|ADDITION OF A NEW TISSUE SUPPLIER.
P040037|S037|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|09/16/2011|||OK30|REPLACEMENT OF THE IN-HOUSE BURST TESTER FOR THE BASE TUBE COMPONENT.
P950024|S036|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI EPICARDIAL PACING LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|09/21/2011|||OK30|NEW PROCESS SETTINGS ESTABLISHED FOR A BLISTER SEALER MACHINE.
P840062|S022|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING|LPG|DE|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/18/2011|03/19/2012|||APPR|APPROVAL FOR THE ADDITION OF AN ADDITIONAL TRADE MAME, FROM ORACOTE, TO THE COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY PRODUCTS.
P100021|S010|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/18/2011|09/16/2011|||APPR|APPROVAL FOR MINOR LABELING CHANGES TO UPDATE CAUTION STATEMENTS.
P030002|S025|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||Lens,intraocular,accommodative|CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS|NAA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2011|09/15/2011|||OK30|REFURBISHMENT OF AN AUTOCLAVE STERILIZER.
P100010|S011|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2011|09/15/2011|||OK30|VARIOUS CHANGES INCLUDING THE ADDITION OF A NEW MICROMETER AND NEW EQUIPMENT FOR RESISTANCE AND CONTINUITY TESTING.
P990043|S014|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2011|09/16/2011|||OK30|USE OF AN ADDITIONAL VENDOR OF CHROMOGEN/SUBSTRATE BULK SOLUTION TO MANUFACTURE THE FINAL CHROMOGEN/SUBSTRATE REAGENT FOR THE ETI-EBK PLUS KIT. THE STABILITY DATA FOR THE NEW VENDOR'S CHROMOGEN/ SUBSTRATE REAGENT USING THE APPROVED PROTOCOL SUPPORTS AN EXPIRATION DATE OF 16 MONTHS.
P100031|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P100032|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2011|09/23/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH IN MANNHEIM, GERMANY.
P820003|S112|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ELECTROLESS NICKEL IMMERSION GOLD PROCESS (ENIG) PROCESS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2011|09/16/2011|||OK30|CHANGE FROM MANUAL TO AUTOMATED PROCESS AT A SUPPLIER LOCATION.
P090022|S007|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD INTRAOCULAR LENS (IOL)|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2011|12/20/2011|||APPR|APPROVAL OF A NEW LENS ANALYZER.
P020045|S039|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2011|09/15/2011|||OK30|VARIOUS CHANGES INCLUDING THE ADDITION OF A NEW MICROMETER AND NEW EQUIPMENT FOR RESISTANCE AND CONTINUITY TESTING.
P950037|S098|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2011|09/30/2011|||APPR|APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1101.U.
P000009|S046|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2011|09/30/2011|||APPR|APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1101.U.
P050023|S046|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2011|09/30/2011|||APPR|APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1101.U.
P070008|S026|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW-L BP LEADS|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/19/2011|09/30/2011|||APPR|APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1101.U.
P000044|S027|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2011|09/16/2011|||OK30|CONVERSION OF THE IN PROCESS LIMIT FROM A SIGNAL RATIO TO A TEST RESULT.
P000058|S045|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/19/2011|12/23/2011|||APPR|APPROVAL FOR MODIFICATION TO THE ADVERSE EVENT REPORTING TABLE IN THE PACKAGE INSERT DUE TO IDENTIFICATION OF TRANSPOSITION AND TYPOGRAPHICAL ERRORS.
P110001|S001|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2011|09/21/2011|||OK30|CHANGES TO THE SOLUTION MANUFACTURING PROCESS.
P010012|S271|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICD MODELS E102, E103, E110, E111|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2011|09/15/2011|||OK30|ALTERNATE SUPPLIERS FOR CERAMIC CAPACITORS.
P960040|S245|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT MODELS N118, N19|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2011|09/15/2011|||OK30|ALTERNATE SUPPLIERS FOR CERAMIC CAPACITORS.
P050023|S047|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 500/540 ICDS THORACIC IMPEDANCE|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/2011|11/17/2011|||APPR|APPROVAL FOR THE ADDITION OF THE THORACIC IMPEDANCE (TI) MEASUREMENT FEATURE TO THE CURRENTLY APPROVED LUMAX 500/540 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEFIBRILLATOR DEVICES.
P000053|S038|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2011|09/20/2011|||OK30|NEW SOFTWARE-BASED MONITORING SYSTEM FOR A MANUFACTURING PROCESS.
P030019|S018|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2011|04/30/2014|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATIVE SUPPLIER FOR MATERIALS.
P860004|S158|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2011|12/09/2011|||APPR|APPROVAL FOR THE FOLLOWING: 1) THE ASSEMBLY PROCESS FOR THE ROLLER SUBCOMPONENT OF THE PUMPHEAD CURRENTLY USES A MANUAL PRESS AND WILL BE CHANGED TO USE A MOTORIZED PRESS THAT MONITORS AND CONTROLS TRAVEL DISTANCE AND ASSEMBLY FORCE. THIS CHANGE IS INTENDED TO IMPROVE YIELD AND MANUFACTURING EFFICIENCY; 2) THE MANUFACTURING TOLERANCE FOR THE NON-CRITICAL DIMENSION FOR THE PUMPHEAD ASSEMBLY DEFINED AS THE "STOP POSITION" WILL BE CHANGED FROM 10.77 + 0.044/-0.046 MILLIMETERS TO10.77 +/-0.060 MILLIMETERS. THE CRITICAL COMPONENT SPECIFICATION OF FORCE APPLIED BY THE PUMPHEAD ROLLERS ON THE PUMP TUBE IS NOT CHANGING. THIS CHANGE IS INTENDED TO IMPROVE YIELD OF THE PUMPHEAD COMPONENT; AND 3) THE MANUFACTURING TOLERANCE FOR THE NON-CRITICAL DIMENSION FOR RIVET DIAMETER USED TO ASSEMBLE THE SUPPORT ROLLER ARM SIDES AND SUPPORT ROLLER ARM CENTER IN THE PUMPHEAD ASSEMBLY WILL BE CHANGED FROM 1 +/   -0.002 MILLIMETERS TO 1 +/-0.006 MILLIMETERS. THE RIVETS WILL ALSO BE SORTED BASED ON THE INDIVIDUAL DIAMETER TO MATCH WITH THE DIAMETER OF THE HOLES IN THE ASSEMBLY THEY ARE INSERTED INTO TO PREVENT INTERFERENCE. THE CRITICAL COMPONENT SPECIFICATION OF MINIMUM PRESS OUT FORCE AFTER THE RIVET IS PRESSED INTO PLACE IS NOT CHANGING. THIS CHANGE IS INTENDED TO IMPROVE YIELD OF THE PUMPHEAD COMPONENT.
P980035|S240|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/RELIA/SENSIA/VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2011|09/22/2011|||OK30|PROCESS ADJUSTMENTS FOR TITANIUM AND OXIDE LAYER THICKNESSES.
P060030|S022|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2011|09/22/2011|||OK30|REVISION OF THE IN-PROCESS TESTING ASSAY VALIDATION CRITERIA FOR THE POSITIVE CONTROL BULK MATERIALS USED FOR THE DEVICE.
P970018|S024|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|PREPSTAIN SYSTEM/PREPMATE|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/2011|09/21/2011|||APPR|APPROVAL FOR UPDATING THE PRODUCT LABELING AND THE PREPMATE OPERATOR MANUAL.  REQUESTED CHANGES TO THE PRODUCT LABELING INCLUDE UPDATING THE MET MARK, UPDATING THE MANUFACTURING ADDRESS AND EC AUTHORIZED REPRESENTATIVE NAME AND ADDRESS, ADDING CE MARK, AND ADDING BD BRANDING TO SERIAL NUMBER LABELS AND BOX LABELS. CHANGES TO THE OPERATOR MANUAL INCLUDE EDITORIAL CHANGES INTENDED TO CLARIFY AND/OR CORRECT SOME EXISTING TEXT, WHICH INCLUDED UPDATING THE COMPANY AND INSTRUMENT NAME AND BRANDING.
P040034|S020|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2011|12/16/2011|||APPR|APPROVAL FOR THE ADDITION OF A SCAN HEIGHT RANGE FOR THE IRRADIATION BEAM AT THE STERILIZATION VENDOR.
P090018|S013|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|08/26/2011|10/28/2011|||APPR|APPROVAL FOR USER INTERFACE FIRMWARE CHANGES TO THE ESTEEM PERSONAL PROGRAMMER.
P000058|S046|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2011|10/05/2011|||APPR|APPROVAL FOR REPLACING THE PLASTISOL CAPS USED TO HOLD THE FUSION CAGE COMPONENT WITH POLYETHYLENE BAGS.
P910001|S049|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX EXCIMER LASER SYSTEMS|LPC|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/26/2011|10/25/2011|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE CVX-300 AND CVX-300-P LASER SYSTEMS.
P860003|S061|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2011|09/22/2011|||OK30|MOLDING PROCESS CHANGE FOR A COMPONENT OF THE CELLEX PROCEDURE KIT.
P060002|S020|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2011|09/22/2011|||OK30|USE OF A NEW MOLD MADE FROM A DIFFERENT MATERIAL FOR MANUFACTURE OF A CRITICAL DEVICE COMPONENT.
P980022|S098|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP & PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2011|09/22/2011|||OK30|COMPONENT MANUFACTURING LOCATION CHANGE FOR THE SUPPLIER OF THE VIBRATOR MOTOR USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME PUMP AND THE PARADIGM REAL-TIME REVEL PUMP.
P000025|S056|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|09/23/2011|||OK30|CHANGE IN EQUIPMENT USED FOR THE PRODUCTION OF THE ELECTRODE WIRES OF ALL COCHLEAR IMPLANTS.
P000006|S026|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|09/26/2011|||OK30|ADDITION OF A NEW PIECE OF AUTOMATIC EQUIPMENT IN THE MANUFACTURING PROCESS.
P040044|S039|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|02/13/2012|||APPR|APPROVAL FOR MODIFICATIONS TO YOUR BALLOON TUBE NECKING PROCESS.
P040002|S033|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ACCESSORY STENT GRAFT DELIVERY SYSTEMS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|09/29/2011|||OK30|AUTOMATION OF A LOADING PROCESS.
P970051|S086|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|12/02/2011|||APPR|APPROVAL TO USE THE SAME CHIP AND BONDING MATERIAL EMPLOYED IN THE DESIGN OF THE CP180 SOUND PROCESSOR IN THE FREEDOM SOUND PROCESSOR.
P000023|S007|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM|LZD|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|06/27/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TMJ MEDICAL IN GOLDEN, COLORADO.
P090022|S008|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|09/28/2011|||OK30|REMOVAL OF TWO MANUFACTURING PROCESS STEPS IN ORDER TO MAKE THE IOL MANUFACTURING PROCESS MORE EFFICIENT.
P930014|S054|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|09/26/2011|||OK30|IMPLEMENT TIGHTER TEMPERATURE AND RELATIVE HUMIDITY CONTROLS IN THE FORMULATION PROCESS OF THE PRODUCTS.
P040020|S035|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|09/26/2011|||OK30|IMPLEMENT TIGHTER TEMPERATURE AND RELATIVE HUMIDITY CONTROLS IN THE FORMULATION PROCESS OF THE PRODUCTS.
P930016|S035|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/2011|07/17/2012|||APPR|APPROVAL FOR SOFTWARE VERSION 5.32.
P000035|S007|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM|MPI|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|06/27/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TMJ MEDICAL IN GOLDEN, COLORADO.
P990012|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|11/17/2011|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES.
P010054|S016|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|11/17/2011|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES.
P090007|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|11/17/2011|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES.
P090008|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|11/17/2011|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES.
P090009|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|11/17/2011|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES.
P100031|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|11/17/2011|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES.
P100032|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|11/17/2011|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES.
P100027|S001|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/2011|10/13/2011|||APPR|APPROVAL FOR MODIFICATION OF THE STABILITY TESTING PROTOCOL TO ALLOW FOR EXTENSION OF THE SHELF LIFE OF THE DEVICE FROM 6 MONTHS TO 18 MONTHS.
P010068|S025|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS & NAVISTAR DS CATHETER/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR DS CATHETER/INTERFACE CABLES|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|10/07/2011|||OK30|PARAMETRIC RELEASE OF STERILIZED PRODUCT USING ETHYLENE OXIDE.
P030031|S035|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL/CELSIUS RMT THERMOCOOL/NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/NAV CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|10/07/2011|||OK30|PARAMETRIC RELEASE OF STERILIZED PRODUCT USING ETHYLENE OXIDE.
P040036|S026|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/EZ STEER THERMOCOOL NAV CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|10/07/2011|||OK30|PARAMETRIC RELEASE OF STERILIZED PRODUCT USING ETHYLENE OXIDE.
P950005|S035|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|10/07/2011|||OK30|PARAMETRIC RELEASE OF STERILIZED PRODUCT USING ETHYLENE OXIDE.
P990025|S029|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR CATHETERS/INTERFACE CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|10/07/2011|||OK30|PARAMETRIC RELEASE OF STERILIZED PRODUCT USING ETHYLENE OXIDE.
P990071|S015|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|INTERFACE CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2011|10/07/2011|||OK30|PARAMETRIC RELEASE OF STERILIZED PRODUCT USING ETHYLENE OXIDE.
P100013|S002|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice||N|08/30/2011|09/27/2011|||OK30|SEVERAL MANUFACTURING CHANGES AT TWO DIFFERENT SUPPLIERS.
P980016|S319|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA/PROTECTA XT|LWS|CV|30-Day Notice||N|08/30/2011|09/29/2011|||OK30|CHANGES TO HYBRID ACCEPTANCE TESTING.
P010031|S273|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA/PROTECTA XT||CV|30-Day Notice||N|08/30/2011|09/29/2011|||OK30|CHANGES TO HYBRID ACCEPTANCE TESTING.
P970020|S068|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ZETA RX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2011|09/27/2011|||OK30|MODIFICATION IN THE CUTTING PROCESS OF A COMPONENT.
P020047|S039|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION RAPID EXCHANGE (RX) & MINI VISION RX MULTI-LINK FAMILY OF CORONARY STENT SYSTEM (CSS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2011|09/27/2011|||OK30|MODIFICATION IN THE CUTTING PROCESS OF A COMPONENT.
P070015|S080|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V RX & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2011|09/27/2011|||OK30|MODIFICATION IN THE CUTTING PROCESS OF A COMPONENT.
P090022|S009|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2011|11/16/2011|||APPR|APPROVAL FOR THE WAY IN WHICH A TEST REAGENT IS INCUBATED.
P040043|S041|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|THE GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2011|12/21/2011|||APPR|APPROVAL FOR MODIFICATION TO YOUR SAMPLING PLAN FOR FATIGUE TESTING.
P050028|S021|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST|MKT|MI|Special (Immediate Track)||N|09/01/2011|09/30/2011|||APPR|APPROVAL FOR THE REVISIONS OF THE PACKAGE INSERT FOR THE DEVICE.
P010032|S041|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS & EON FAMILY OF NEUORSTIMULATION DEVICES|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/29/2011|10/28/2011|||APPR|APPROVAL FOR A MODIFICATION TO THE AMPLITUDE BUTTON OF THE PATIENT PROGRAMMER THAT ADDED MATERIAL TO PREVENT OFF-CENTER ACTUATIONS.
P000012|S034|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|Special (Immediate Track)||N|09/01/2011|09/29/2011|||APPR|APPROVAL FOR THE REVISION OF THE PACKAGE INSERT FOR THE COBAS AMPIPREP/COBAS AMPLICOR HCV TEST, V2.0.
P880086|S209|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2011|09/28/2011|||APPR|APPROVAL FOR THE  MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030035|S088|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2011|09/28/2011|||APPR|APPROVAL FOR THE  MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P880006|S074|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2011|09/28/2011|||APPR|APPROVAL FOR THE  MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P000040|S019|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2011|10/03/2011|||OK30|ADDITION OF A NEW MANUFACTURING FIXTURE AND THE MODIFICATIONS OF AN EXISTING MANUFACTURING FIXTURE.
P970013|S043|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2011|09/28/2011|||APPR|APPROVAL FOR THE  MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P100023|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2011|09/27/2011|||OK30|UPDATE OF SOFTWARE TO EXISTING PROCESS EQUIPMENT AND MODIFICATION OF CORRESPONDING PROCESS STEPS.
P910023|S273|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CADENCE/CURRENT FAMILY OF ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2011|09/28/2011|||APPR|APPROVAL FOR THE  MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P030054|S199|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF/PROMOTE FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2011|09/28/2011|||APPR|APPROVAL FOR THE  MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
P020009|S077|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2011|09/27/2011|||OK30|CHANGES TO PROCESS METHODS AND SOFTWARE SUPPORTING THE PLASMA TREATER AND THE HYDROPHILIC COATING (HPC) EQUIPMENT.
P040016|S076|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (FORMERLY LIBERTE) OTW BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2011|09/27/2011|||OK30|CHANGES TO PROCESS METHODS AND SOFTWARE SUPPORTING THE PLASMA TREATER AND THE HYDROPHILIC COATING (HPC) EQUIPMENT.
P060008|S075|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2011|09/27/2011|||OK30|CHANGES TO PROCESS METHODS AND SOFTWARE SUPPORTING THE PLASMA TREATER AND THE HYDROPHILIC COATING (HPC) EQUIPMENT.
P100023|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2011|09/27/2011|||OK30|CHANGES TO PROCESS METHODS AND SOFTWARE SUPPORTING THE PLASMA TREATER AND THE HYDROPHILIC COATING (HPC) EQUIPMENT.
P970003|S135|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/01/2011|10/31/2011|||APPR|APPROVAL FOR AN UPGRADE TO THE COMMUNICATION FLASH LOADER (CFL) PORTION OF THE FIRMWARE OF THE DEMIPULSE IMPLANTABLE PULSE GENERATORS, MODEL 103 AND MODEL 104.
P930014|S055|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/01/2011|10/31/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE ACRYSOF INTRAOCULAR LENS (IOL) CASE (#79 AND #80) DRAINAGE FEATURES.
P040020|S036|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/01/2011|10/31/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE ACRYSOF® INTRAOCULAR LENS (IOL) CASE (#79 AND #80) DRAINAGE FEATURES.
P060027|S032|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/2011|04/10/2012|||APPR|APPROVAL FOR THE PARADYM RF CRT-D AND PARADYM RF ICD.
P980049|S065|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/01/2011|04/10/2012|||APPR|APPROVAL FOR THE PARADYM RF CRT-D AND PARADYM RF ICD.
P030054|S200|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MERLIN PATIENT CARE SYSTEM MODEL 3650|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/02/2011|10/20/2011|||APPR|APPROVAL FOR CHANGES TO THE INTERNAL COMPONENTS OF THE DEVICE.
N17600|S025|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR & ULTRAFOAM CAST SPONGE/(MCH) ULTRAWRAP/(MCH0 SYRINGEAVITENE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2011|09/29/2011|||OK30|CHANGES TO QUALITY CONTROL TESTING FOR INCOMING RAW MATERIAL (BOVINE CORIUM) AND MODIFICATION TO FINISHED GOODS TESTING.
P800002|S017|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB & ENDOAVITENE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2011|09/29/2011|||OK30|CHANGES TO QUALITY CONTROL TESTING FOR INCOMING RAW MATERIAL (BOVINE CORIUM) AND MODIFICATION TO FINISHED GOODS TESTING.
N18286|S022|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/06/2011|02/29/2012|||APPR|APPROVAL FOR A NEW CONVENIENCE KIT, GELFOAM PLUS ¿ POWDER TO BE COMPRISED OF GELFOAM POWDER, HUMAN THROMBIN, ONE SYRINGE THAT IS PRE-FILLED WITH 0.9% NAC1 SOLUTION, ONE EMPTY SYRINGE, A NEEDLELESS TRANSFER DEVICE AND AN APPLICATOR TIP.
P930014|S056|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2011|09/29/2011|||OK30|ADDITION OF AN 8-CAVITY FIXED WAFER MOLD M-5.
P040020|S037|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENS (IOL)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2011|09/29/2011|||OK30|ADDITION OF AN 8-CAVITY FIXED WAFER MOLD M-5.
P940015|S023|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC & SYNVISC-ONE (HYLAN G-F 20)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2011|10/07/2011|||OK30|ADDITION OF A RAW MATERIAL IDENTIFICATION SYSTEM AND AN AUTOMATED FILTER INTEGRITY TEST INSTRUMENT.
P030032|S013|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|PREVELLE SILK|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2011|10/07/2011|||OK30|ADDITION OF A RAW MATERIAL IDENTIFICATION SYSTEM AND AN AUTOMATED FILTER INTEGRITY TEST INSTRUMENT.
P000041|S010|RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|CLEARREAD DETECT|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/2011|11/08/2011|||APPR|APPROVAL FOR THE ONGUARD 5.2.1 COMPUTER AIDED DETECTION SOFTWARE.
P960013|S067|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL FAMILY OF LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2011|10/06/2011|||OK30|INCREASE THE LENGTH OF THE RING ELECTRODE MASKING.
P110020|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|ROCHE COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2011|10/17/2011|||OK30|ADDITIONAL OF FUNCTIONAL TESTING AT THE FINAL VIAL STAGE IN THE MANUFACTURE OF THE DEVICE MUTATION POSITIVE CONTROL (MU) AND THE WILD-TYPE CONTROL (WT).
P060003|S010|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT AXSYM AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2011|10/03/2011|||OK30|CHANGE TO VENDOR FOR THE INCOMING NON-FAT DRY MILK.
P040020|S038|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2011|10/06/2011|||OK30|MODIFICATIONS TO THE FINAL CLEANING PROCESS.
P020045|S040|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2011|10/07/2011|||OK30|CHANGE TO REDUCE ADHESIVE CURING TIME FOR ECG RINGS AND THE TIP ELECTRODE.
P100010|S012|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2011|10/07/2011|||OK30|CHANGE TO REDUCE ADHESIVE CURING TIME FOR ECG RINGS AND THE TIP ELECTRODE.
P880086|S210|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|SUSTAIN XL  SC, DC, SR, DR PACEMAKER MODELS PM1134, PM2134, PM1136, PM2136|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2011|10/14/2011|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION IN PENANG, MALAYSIA.
P910007|S031|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|AXSYM TOTAL PSA & ARCHITECT TOTAL PSA|MTF|IM|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|09/07/2011|09/13/2011|||APPR|APPROVAL FOR ADDITION OF A BSA SCREENING TEST TO IDENTIFY PROTEASE CONTAMINATION IN VENDOR LOTS OF INCOMING BSA PRIOR TO PURCHASE.
P980007|S022|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|AXSYM FREE PSA & ARCHITECT FREE PSA|MTG|IM|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|09/07/2011|09/13/2011|||APPR|APPROVAL FOR ADDITION OF A BSA SCREENING TEST TO IDENTIFY PROTEASE CONTAMINATION IN VENDOR LOTS OF INCOMING BSA PRIOR TO PURCHASE.
P010013|S041|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/07/2011|02/01/2013|||APPR|APPROVAL OF LABELING CHANGES PERTAINING TO THE USE OF NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION IN PATIENTS WHO HAVE MICRO-INSERTS FROM THE ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL TRAILING INTO THE ENDOMETRIAL CAVITY FROM THE FALLOPIAN TUBES.
P960042|S031|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH DEVICE|MFA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/06/2011|04/20/2012|||APPR|APPROVAL FOR AN INCREASE IN THE MAXIMUM REPETITION RATE FROM 40 HZ TO 80 HZ OF THE SPECTRANETICS LASER SHEATH.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLIDELIGHT LASER  SHEATH.
P060035|S010|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|09/07/2011|10/07/2011|||APPR|APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE.
P060012|S008|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE|LOM|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|09/07/2011|10/07/2011|||APPR|APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE.
P970027|S015|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|09/07/2011|10/07/2011|||APPR|APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE.
P070014|S024|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2011|10/07/2011|||OK30|CHANGE TO THE TENSILE TESTING PROCESS.
P090002|S001|DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/07/2011|11/04/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040023|S018|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM|MRA|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/2011|03/08/2012|||APPR|APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE FOR THE DURALOC OPTION CERAMIC HIP SYSTEM.
P910023|S274|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2011|10/07/2011|||OK30|CHANGES TO THE LIMITS FOR A DEVICE LEVEL MANUFACTURING TEST AS WELL AS THE ADDITION OF IN-PROCESS VERIFICATION TESTS.
P030054|S201|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2011|10/07/2011|||OK30|CHANGES TO THE LIMITS FOR A DEVICE LEVEL MANUFACTURING TEST AS WELL AS THE ADDITION OF IN-PROCESS VERIFICATION TESTS.
P030054|S202|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FORTIFY AND VARIOUS FAMILIES OF CURRENT|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/2011|11/01/2011|||APPR|APPROVAL FOR THE INTRODUCTION OF THE IS4/DF4 PORT PLUG ACCESSORY MODEL AC-IS4PP FOR USE WITH ALL SJM DF4 OR IS4 HEADER PORTS.
P040045|S025|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2011|10/12/2011|||OK30|UPGRADE TO THE SALINE DOSE HEAD DURING THE MANUFACTURING OF THE DEVICE.
P030017|S123|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2011|10/12/2011|||OK30|ADD AN ALTERNATIVE WELDER FOR THE ANTENNA WELDING PROCESS.
P870025|S010|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|FETAL ACOUSTIC STIMULATOR|MCP|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2011|10/12/2011|||OK30|CHANGES TO THE SUPPLIERS FOR COMPONENTS OF THE FAST DEVICE.
P000010|S025|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|AMPLICOR HCV TEST V2.0 & COBAS AMPLICOR HCV TEST V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2011|10/11/2011|||OK30|CHANGES TO THE ROOM LOCATION AND EQUIPMENT FOR FILLING AND LABELING OF CERTAIN VIALED INTERMEDIATE COMPONENTS.
P000012|S035|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2011|10/11/2011|||OK30|CHANGES TO THE ROOM LOCATION AND EQUIPMENT FOR FILLING AND LABELING OF CERTAIN VIALED INTERMEDIATE COMPONENTS.
P060030|S023|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2011|10/11/2011|||OK30|CHANGES TO THE ROOM LOCATION AND EQUIPMENT FOR FILLING AND LABELING OF CERTAIN VIALED INTERMEDIATE COMPONENTS.
P050028|S022|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2011|10/11/2011|||OK30|CHANGES TO THE ROOM LOCATION AND EQUIPMENT FOR FILLING AND LABELING OF CERTAIN VIALED INTERMEDIATE COMPONENTS.
P910056|S010|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/12/2011|05/30/2012|||APPR|APPROVAL FOR A MATERIAL CHANGE AND DESIGN MODIFICATIONS (3-PIECE TO 1-PIECE DESIGN AND ASPHERIC SURFACE) TO THE APPROVED BAUSCH & LOMB SILICONE LENS C31UB.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENVISTA ONE-PIECE HYDROPHOBIC ACRYLIC INTRAOCULAR LENS, MODEL MX60 AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM THE CATARACTOUS CRYSTALLINE LENS HAS BEEN REMOVED.
P980016|S321|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST; INTRINSIC; MARQUIS; ONYX; SECURA; VARIOUS FAMILIES OF GEM, MAXIMO, PROTECTA, & VIRTUOSO|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2011|10/31/2011|||APPR|APPROVAL FOR AN UPDATE TO THE LIFE TEST SPECIFICATIONS OF HIGH VOLTAGE CAPACITORS.
P010031|S275|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA; MAXIMO II; & VARIOUS FAMILIES OF CONCERTO, INSYNC, & PROTECTA|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2011|10/31/2011|||APPR|APPROVAL FOR AN UPDATE TO THE LIFE TEST SPECIFICATIONS OF HIGH VOLTAGE CAPACITORS.
P060011|S002|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7||intraocular lens|C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2011|11/22/2011|||APPR|APPROVAL FOR THE ADDITION OF AN ASPHERIC OPTICAL SURFACE TO THE ANTERIOR SURFACE OF THE PARENT C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 570C, AS WELL AS THE ADDITION OF A MODULATION TRANSFER FUNCTION (MTF) FIGURE TO THE PHYSICIANS LABELING COMPARING BOTH MODELS (I.E., 970C AND 570C).
P910023|S275|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2011|10/12/2011|||OK30|USE OF AN ALTERNATE SUPPLIER FOR BACK-UP BANDS.
P030054|S203|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2011|10/12/2011|||OK30|USE OF AN ALTERNATE SUPPLIER FOR BACK-UP BANDS.
P040003|S010|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE|NRZ|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/2011|12/08/2011|||APPR|APPROVAL FOR MODIFICATION OF THE EXABLATE PLATFORM 1) SO THAT THE SAME PLATFORM CAN BE USED WITH MULTIPLE CRADLES; AND 2) TO ENABLE THE CRADLE THAT HAS THE CAPABILITY TO MOVE THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTIONS BE USED IN THE LOCKED POSITION FORCOMMERCIAL UTERINE FIBROID TREATMENT.
P100023|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2011|10/06/2011|||OK30|ADDITION OF THE ION STENT SYSTEM TO STERILIZATION CHAMBER 6 AT COVENTRY, RHODE ISLAND.
P850068|S009|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, extended wear|BAUSCH & LOMB SILSOFT (ELASTOFILCON A) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2011|10/14/2011|||OK30|CHANGE THE MANUFACTURING PROCESS OF THE OPTICAL TOOLS USED TO MANUFACTURE THE DEVICE.
P020052|S008|St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT|MTE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2011|10/13/2011|||OK30|ELIMINATE THE UV POST TRIM PROCESS.
P000037|S024|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2011|02/17/2012|||APPR|APPROVAL FOR RELOCATING A SEALING MACHINE FROM A CONTRACT MANUFACTURER TO IN-HOUSE.
P020004|S064|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2011|11/17/2011|||APPR|APPROVAL FOR THE ADDITION OF THE 23 AND 27 MM CONTRALATERAL LEG COMPONENT AND SEVERAL MINOR LABELING CHANGES.
P950009|S013|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT SLIDE PROFILER|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2011|11/10/2011|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE BD FOCALPOINT SLIDE PROFILER FROM THE CURRENT PRODUCTION VERSION APPS 3.4.1A TO APPS 3.5.0.
P060008|S077|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2011|10/14/2011|||OK30|IMPLEMENTATION OF A SEMI-AUTOMATED KITTING PROCESS OF ACCESSORY KITS AT A CONTRACT SUPPLIER.
P040016|S078|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2011|10/14/2011|||OK30|IMPLEMENTATION OF A SEMI-AUTOMATED KITTING PROCESS OF ACCESSORY KITS AT A CONTRACT SUPPLIER.
P060008|S078|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2011|10/14/2011|||OK30|CHANGE TO THE FEEDSTOCK SOURCE FOR THE MANUFACTURING OF A SOLVENT.
P100023|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2011|10/14/2011|||OK30|CHANGE TO THE FEEDSTOCK SOURCE FOR THE MANUFACTURING OF A SOLVENT.
P910023|S276|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PROMOTE AND UNIFY|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/2011|11/01/2011|||APPR|APPROVAL FOR THE INTRODUCTION OF THE IS4/DF4 PORT PLUG ACCESSORY MODEL AC-IS4PP FOR USE WITH ALL SJM DF4 OR IS4 HEADER PORTS.
P970027|S016|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2011|10/19/2011|||OK30|RELOCATION OF A FORMULATION ROOM FOR THE LYOPHILIZATION OF ALKALINE-TREATED CASEIN USED IN THE DEVICE.
P010047|S013|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2011|10/19/2011|||OK30|REDUCTION IN SAMPLE SIZE OF THE CURRENT TESTING FOR THE APPLICATOR KITS.
P980035|S241|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2011|10/13/2011|||OK30|SOFTWARE UPDATES FOR A TESTING APPLICATION.
P010015|S138|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P & SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2011|10/13/2011|||OK30|SOFTWARE UPDATES FOR A TESTING APPLICATION.
P090013|S039|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2011|10/13/2011|||OK30|SOFTWARE UPDATES FOR A TESTING APPLICATION.
P990001|S095|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+ C SERIES & VITATRO DA+ T SERIES IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2011|10/13/2011|||OK30|SOFTWARE UPDATES FOR A TESTING APPLICATION.
P980016|S322|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2011|10/13/2011|||OK30|SOFTWARE UPDATES FOR A TESTING APPLICATION.
P010031|S276|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONCERTO II/CONSULTA/INSYNC II & III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO PROTECTA/PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2011|10/13/2011|||OK30|SOFTWARE UPDATES FOR A TESTING APPLICATION.
P990065|S006|SIRTEX MEDICAL LIMITED|UNIT F6 PARKVIEW 16 MARS ROAD||LANE COVE||NSW 2||Microspheres radionuclide|SIR-SPHERES|NAW|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2011|07/17/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SIRTEX SINGAPORE PTE LTD. IN SINGAPORE.
P040012|S042|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/2011|03/29/2012|||APPR|APPROVAL FOR ADDITION OF THE EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS) TO THE STANDARD RISK INDICATION AND AN UPDATE TO THE MAGNETIC RESONANCE COMPATIBILITY SECTION OF THE LABELING.
P920047|S049|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR THE INTERNAL GLUE FLAP AND THE CARTON END CLOSURE CHANGES TO THE PACKAGING DESIGN.
P020025|S031|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|MAESTRO 3000 CARDIAC ABLATION SYSTEM|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR THE INTERNAL GLUE FLAP AND THE CARTON END CLOSURE CHANGES TO THE PACKAGING DESIGN.
P980003|S031|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR THE INTERNAL GLUE FLAP AND THE CARTON END CLOSURE CHANGES TO THE PACKAGING DESIGN.
P100027|S002|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/19/2011|02/15/2012|||APPR|APPROVAL FOR MIGRATION OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY TO THE BENCHMARK ULTRA AUTO-STAINER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY AND IS INDICATED FOR USE INDETERMINING HER2 GENE STATUS BY ENUMERATION OF THE RATIO OF THE HER2 GENE TO CHROMOSOME 17.  THE HER2 AND CHROMOSOME 17 PROBES ARE DETECTED USING TWO COLOR CHROMOGENIC IN SITU HYBRIDIZATION (ISH) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS FOLLOWING STAINING ON VENTANA BENCHMARK XT AUTOMATED SLIDE STAINERS (USING NEXES SOFTWARE), OR ON VENTANA BENCHMARK ULTRA AUTOMATED SLIDE STAINER (USING VSS SOFTWARE), BY LIGHTMICROSCOPY. THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED READER IN CONJUNCTION WITH HISTOLOGICAL EXAMINATION, RELEVANT CLINICAL INFORMATION, AND PROPER CONTROLS. THIS REAGENT IS INTENDED FOR IN VITRO DIAGNOSTIC (IVD) USE.
N18033|S061|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2011|02/01/2012|||APPR|APPROVAL FOR THE IMPLEMENTATION OF AN ALTERNATE TEST METHOD FOR DETERMINING THE PURITY OF THE RAW MATERIALS USED IN REACTIVE MONOMER MIX FORMULATION.
P040045|S026|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2011|02/01/2012|||APPR|APPROVAL FOR THE IMPLEMENTATION OF AN ALTERNATE TEST METHOD FOR DETERMINING THE PURITY OF THE RAW MATERIALS USED IN REACTIVE MONOMER MIX FORMULATION.
P020009|S078|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS & EXPRESS2 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2011|10/19/2011|||OK30|ADDITIONAL STERILIZATION CYCLE FOR THE DEVICE.
P100018|S004|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2011|03/22/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT EV3 NEUROVASCULAR, IRVINE, CALIFORNIA AS AN ADDITIONAL MANUFACTURING SITE FOR THE DEVICE.
P890003|S235|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY, MINUET, SYNERGYST II, & VARIOUS FAMILIES/MODELS OF ELITE, PREVA, THERA, & VITATRON LEGACY|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P900061|S110|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM, PCD, & VARIOUS FAMILIES/MODELS OF JEWEL|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P970012|S089|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P930022|S013|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P980016|S323|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST, INTRINSIC, MARQUIS, ONYX, SECURA, & VARIOUS FAMILIES/MODELS OF GEM, MAXIMO, PROTECTA, & VIRTUOSO|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P980035|S242|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, RELIA, SENSIA, SIGMA, VERSA, & VARIOUS FAMILIES/MODELS OF KAPPA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P980050|S067|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF, GEM III AT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P010015|S139|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONSULTA CRT-P, SYNCRA CRT-P, INSYNC/INSYNC III|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P090013|S040|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P990001|S096|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DIVA IPG FAMILY, DEMA IPG FAMILY, & VARIOUS C-SERIES & T-SERIES DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P010031|S277|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA CRT-D, MAXIMO II CRT-D, & VARIOUS FAMILIES/MODELS OF CONCERTO, INSYNC, & PROTECTA|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P820003|S113|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS FAMILIES/MODELS OF PASYS, SPECTRAX, SYMBIOS, & SYNERGYST|LWP|CV|Real-Time Process||N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
P850051|S078|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|VITATRON LEGACY, PREVAIL, PREMIER, & VARIOUS FAMILIES/MODELS OF ACTIVITRAX, LEGEND, MINIX|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2011|11/17/2011|||APPR|APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
N16837|S008|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2011|01/10/2012|||APPR|UPDATING OF THE STERILANT ETHYLENE OXIDE RESIDUAL PARAMETER.
P970003|S136|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2011|10/18/2011|||OK30|CHANGE TO INVENTORY CONTROL AND TRACEABILITY OF COMPONENTS AND SUBASSEMBLIES.
P950022|S078|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/20/2011|05/24/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE DF-1 CONNECTOR REGION OF THE DURATA DEFIBRILLATION LEADS.
P070027|S032|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/20/2011|05/10/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000039|S042|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER, AMPLATZER 45 DELIVERY AND EXCHANGE SYSTEMS (PTFE)|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2011|10/21/2011|||OK30|CHANGE THE CURRENT SEAL TEST METHOD FROM MANUAL TO SEMIAUTOMATIC.
P020024|S034|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER, AMPLATZER 180 DELIVERY AND EXCHANGE SYSTEMS (PTFE)|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2011|10/21/2011|||OK30|CHANGE THE CURRENT SEAL TEST METHOD FROM MANUAL TO SEMIAUTOMATIC.
P040040|S019|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2011|10/21/2011|||OK30|CHANGE THE CURRENT SEAL TEST METHOD FROM MANUAL TO SEMIAUTOMATIC.
P970003|S137|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2011|10/21/2011|||OK30|CHANGE IN THE ACCEPTANCE CRITERIA FOR THE MODEL 102/102R PULSE GENERATORS.
P020001|S009|NEOVENTA MEDICAL AB|NORRA AGATAN 32|SE-431 35|MOLNDAL||||Analyzer, data, obstetric|STAN S31 FETAL HEART MONITOR|HEO|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2011|11/18/2011|||APPR|APPROVAL FOR THE ADDITION OF AN ACCESSORY, THE STAN VIEWER LIVE, WHICH ALLOWS REMOTE VIEWING OF AN ONGOING STAN S31 RECORDING.
P780007|S046|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2011|10/21/2011|||OK30|ADDITION OF STERILIZATION CYCLE RUNS FOR SINGLE BLISTERS, CVI BLISTERS AND SIX PACK BLISTERS TO STERILIZER FEDEGARI.
P970051|S087|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/2011|11/04/2011|||APPR|APPROVAL TO MODIFY THE LAYOUT OF THE NON-HERMETIC REGION OF THE FEEDTHROUGH ASSEMBLY ON THE CURRENTLY APPROVED CI24RE IMPLANT OF THE DEVICE.
P840001|S196|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOR FAMILY OF IMPLANTABLE NEUROSTIMULATORS (INSS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2011|10/21/2011|||OK30|IMPLEMENT SOFTWARE UPDATES TO THE SELF TEST APPLICATION OF THE NEXT GENERATION TESTER.
P960009|S127|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY INSS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2011|10/21/2011|||OK30|IMPLEMENT SOFTWARE UPDATES TO THE SELF TEST APPLICATION OF THE NEXT GENERATION TESTER.
P980035|S243|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ADAPTA/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2011|10/21/2011|||OK30|CHANGE TO UPGRADE THE SOFTWARE VERSION FROM 1.5.1 TO 1.5.2 ON A LASER WELDER AT A SUPPLIER.
P010015|S140|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2011|10/21/2011|||OK30|CHANGE TO UPGRADE THE SOFTWARE VERSION FROM 1.5.1 TO 1.5.2 ON A LASER WELDER AT A SUPPLIER.
P890003|S236|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2011|10/21/2011|||OK30|CHANGE TO UPGRADE THE SOFTWARE VERSION FROM 1.5.1 TO 1.5.2 ON A LASER WELDER AT A SUPPLIER.
P990001|S097|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+ C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2011|10/21/2011|||OK30|CHANGE TO UPGRADE THE SOFTWARE VERSION FROM 1.5.1 TO 1.5.2 ON A LASER WELDER AT A SUPPLIER.
P070014|S025|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/21/2011|11/21/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860004|S159|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|09/23/2011|11/10/2011|||APPR|APPROVAL FOR MINOR CHANGES TO THE DIMENSIONAL SPECIFICATIONS OF THE SYNCHRO MED II PUMP TUBE ASSEMBLY COMPONENT.
P830037|S053|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/23/2011|02/07/2012|||APPR|APPROVAL FOR THE USE THE NEW PHOENIX VT PRINT PADS USED TO TRANSFER INKS ONTO THE LENS SURFACE AND FOR THE ADDITION OF A PRE-CONDITIONING STEP FOR OPTIMAL INK ADHESION ONTO THE LENSES WHEN THE NEW PRINT PAD IS UTILIZED.
P970037|S007|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUOTDELFIA HAFP KIT|LOK|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2011|04/27/2012|||APPR|APPROVAL FOR A CHANGE OF THE DISPENSING LINE USED IN THE MANUFACTURING OF THE CALIBRATORS FOR THE AUTODELFIA AND DELFIA XPRESS HAFP KITS AND THE BUFFER SOLUTION FOR THE DELFIA XPRESS HAFP KIT.
P050006|S021|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2011|10/21/2011|||OK30|REPLACEMENT OF SAND PAPER WITH A LOCK LOOP POLISHING TOOL IN THE MANUFACTURE OF THE SUBJECT DEVICE.
P020004|S065|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2011|10/24/2011|||OK30|CHANGE TO VISUAL INSPECTION CRITERIA FOR THE STENT GRAFT DEPLOYMENT LINE FIBER.
P040043|S042|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2011|10/24/2011|||OK30|CHANGE TO VISUAL INSPECTION CRITERIA FOR THE STENT GRAFT DEPLOYMENT LINE FIBER.
P070014|S026|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT SOLO VASCULAR STENT SYSTEM|NIP|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2011|10/26/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE PRODUCT LABELING, PREDOMINANTLY WITH RESPECT TO IMPROVING THE SAFE USE OF THE DEVICE BY MODIFYING THE STENT DEPLOYMENT PROCEDURE LANGUAGE IN THE INSTRUCTIONS FOR USE, AS WELL AS ADDING NEW SYMBOLS TO THE LABELING.
P010012|S272|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2011|10/26/2011|||OK30|ALTERNATE SUPPLIER OF CERAMIC CAPACITOR USED FOR PULSE GENERATOR (PG) MANUFACTURING.
P960040|S246|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2011|10/26/2011|||OK30|ALTERNATE SUPPLIER OF CERAMIC CAPACITOR USED FOR PULSE GENERATOR (PG) MANUFACTURING.
P030009|S060|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER & MICRO DRIVER CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2011|10/19/2011|||OK30|CHANGING THE PRODUCT PRINT INFORMATION FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P060033|S068|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2011|10/19/2011|||OK30|CHANGING THE PRODUCT PRINT INFORMATION FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P000006|S027|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2011|11/16/2011|||APPR|APPROVAL TO IMPLEMENT A NEW MOLD FOR THE ONE-TOUCH RELEASE (OTR) PUMP BODY AND ASSOCIATED CHANGES TO SEVERAL DIMENSIONAL SPECIFICATIONS.
P980035|S244|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA AND RELIA IMPLANTABLE PULSE GENERATOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2011|11/01/2011|||APPR|APPROVAL FOR UPDATES TO MEDTRONICS ADAPTA/ VERSA/SENSIA AND RELIA IMPLANTABLE PULSE GENERATOR (IPG) APPLICATION SOFTWARE TO CORRECT THE BATTERY MEASUREMENT LOCK-UP CONDITION.
P050047|S020|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2011|01/20/2012|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM 12 MONTHS TO 18 MONTHS FOR THE 1.0ML SYRINGE; AN INCREASE IN THE MONOETHYLGLYCIN-EXYLIDIDE (MEGX) IMPURITY SPECIFICATION FROM <=3% W/W OF LABEL STRENGTH TO <=2.5% W/W OF LABEL STRENGTH; AND AN INCREASE IN INDIVIDUAL UNIDENTIFIED IMPURITIES SPECIFICATIONS FROM <=0.1% W/W OF LABEL STRENGTH TO<=0.2% W/W OF LABEL STRENGTH.
P080007|S007|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|LIFESTAR VASCULAR STENT SYSTEMS|NIO|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2011|11/16/2011|||APPR|APPROVAL FOR REMOVAL OF THE PCRFORMAXX GRIP ON THE DELIVERY SYSTEM, THE ADDITION OF A SMALLER PACKAGING CONFIGURATION, AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFESTAR VASCULAR STENT SYSTEM AND IS INDICATED FOR THE TREATMENT OF ILIAC OCCLUSIVE DISEASE IN PATIENTS WITH SYMPTOMATIC VASCULAR DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.
P010030|S030|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2011|10/26/2011|||OK30|ALTERNATE SUPPLIER FOR THE HOLSTER AND A CHANGE TO THE INCOMING INSPECTION SAMPLING PLAN.
P100029|S009|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2011|10/19/2011|||OK30|CHANGE TO THE IN-PROCESS LIMIT FOR TOTAL VALVE SCORE DURING THE VISUAL INSPECTION AND FUNCTIONAL TEST.
P000053|S039|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2011|10/26/2011|||OK30|CHANGE IN THE PACKAGING PROCESS FOR THE DEVICES.
P010020|S021|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2011|10/26/2011|||OK30|CHANGE IN THE PACKAGING PROCESS FOR THE DEVICES.
P970008|S059|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2011|10/26/2011|||OK30|CHANGE IN ADHESIVE IN THE MANUFACTURING OF THE UROLOGIX TARGIS SYSTEM CONTROL UNITS.
P860003|S062|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEMS|LNR|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/29/2011|10/28/2011|||APPR|APPROVAL FOR A TECHNICAL BULLETIN THAT WILL BE SENT OUT TO USERS OF THE CELLEX¿ SYSTEM.
P050006|S022|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2011|10/27/2011|||OK30|ADDITION OF A PROCEDURE FOR INVENTORY PROCESSING.
P080004|S009|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|LIMULUS AMEBOCYTE LYSATE BACTERIA TEST|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2011|10/26/2011|||OK30|CHANGE TO THE ENDOTOXIN TESTING METHOD.
P110020|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2011|10/26/2011|||OK30|CHANGES TO THE FILLING AND LABELING EQUIPMENT AND LOCATION FOR CERTAIN VIALED INTERMEDIATE COMPONENTS. YOUR FIRM HAS PROPOSED RELOCATION TO BUILDING 502 ROOMS1F24 AND 1F26 FROM BUILDING 502 ROOMS 1F23 AND 1F31 FOR USE OF NEW EQUIPMENT KUGLER LINOLINE 120 FILING AND SCREW-CAPPING LINE WHICH INCLUDES THE ACCRAPLY 4000 AND 35T LABELINGMACHINES.
P050018|S015|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2011|10/27/2011|||OK30|REMOVE REDUNDANT IN-PROCESS INSPECTION TESTS.
P050006|S023|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/19/2011|||OK30|ADDITION OF EXPIRY REPORT REQUIREMENT TO THE RETURN PRODUCT PROCEDURE.
P070007|S032|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/19/2011|||OK30|MODIFICATION OF A WIPING PROCDURE.
P070027|S033|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT SYSTEM & TALENT CONVERTER STENT GRAFT WITH THE XCELERANT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/19/2011|||OK30|MODIFICATION OF A WIPING PROCDURE.
P010019|S026|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/28/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR ISOPROPYL ALCOHOL (IPA).
P960058|S091|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2011|04/27/2012|||APPR|APPROVAL OF DESIGN CHANGES IMPLEMENTED IN THE APPROVED HIRES 90K COCHLEAR IMPLANT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME "HIRES+90KR ADVANTAGE", HEREAFTER REFERRED TO AS "ADVANTAGE." THIS MODIFIED COCHLEAR IMPLANT DESIGN WILL BEMARKETED UNDER A NEW MODEL NUMBER (CI-1500-XXX) AND THE BRAND NAME FOR THE HIRES 90K COCHLEAR IMPLANT, "AURIA HARMONY HIRCSOLUTION BIONIC EAR SYSTEM" WILL BE CHANGED TO "HIRESOLUTION BIONIC EAR SYSTEM." THE ADVANTAGE IMPLANT INCLUDES THE FOLLOWING: A REINFORCED ANTENNA COIL AND AN INTEGRATED SILICONS POCKET FOR THE MAGNET. THE IMPLANT DIGITAL INTEGRATED CIRCUIT HAS ALSO BEEN REVISED TO INCLUDE THE LATEST WAFER ASSEMBLY PROCESSES.
P040045|S027|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENSOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/26/2011|||OK30|UPDATE THE CURRENT TEST METHOD FOR VISTAKON (SENOFILCON A) CONTACT LENSES.
P890055|S035|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|01/05/2012|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE PASSIVATION OF COMPONENTS NEEDED TO MANUFACTURE ACCESSORIES USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP.
P970003|S138|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY GENERATORS, LEADS PROGRAMING SOFTWARE, PROGRAMMING WAND AND ASSCCESORY PACK|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/27/2011|||OK30|IMPLEMENTATION OF STATISTICAL PROCESS CONTROL (SPC) SOFTWARE.
P030017|S124|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|02/01/2012|||APPR|APPROVAL FOR ETHYLENE OXIDE STERILIZATION EQUIPMENT AND ITS ASSOCIATED STERILIZATION CYCLES.
P040016|S079|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (FORMERLY LIBERTE) OTW BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/19/2011|||OK30|UPDATES TO THE HYDROPHILIC COATING (HPC) EQUIPMENT PROCESS.
P060008|S079|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/19/2011|||OK30|UPDATES TO THE HYDROPHILIC COATING (HPC) EQUIPMENT PROCESS.
P100023|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/19/2011|||OK30|UPDATES TO THE HYDROPHILIC COATING (HPC) EQUIPMENT PROCESS.
P100023|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/27/2011|||OK30|CHANGE TO THE IN-PROCESS MONITORING PLAN FOR PROXIMAL AND PORT WELDS.
P100023|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/19/2011|||OK30|UPDATES TO THE MARKER BAND AND DVT EQUIPMENT INSPECTION SOFTWARE.
P070014|S027|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT SOLO VASCULAR STENT SYSTEMS|NIP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/03/2011|11/17/2011|||APPR|APPROVAL FOR A SMALLER PACKAGING CONFIGURATION AND MINOR LABELING CHANGES TO ACCOMMODATE THE CHANGES TO THE PACKAGING.
P000013|S010|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRIDENT SYSTEMS|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|10/03/2011|01/18/2012|||APPR|APPROVAL FOR THE ADDITION OF THE TRITANIUM PSF ACETABULAR SHELLS (SOLID-BACKED AND CLUSTER SCREW-HOLE DESIGNS) AS COMPATIBLE COMPONENTS WITH THE TRIDENT CERAMIC INSERTS, AS WELL AS MODIFICATIONS TO THE TOLERANCES AND SURFACE ROUGHNESS VALUES OF THE TAPER REGION OF ALL COMPATIBLE TRIDENT AND TRITANIUM ACETABULAR SHELLS.  IN ADDITION, LABELING CHANGES WERE MADE TO ADDRESS THE COMPATIBILITY WITH THE NEW COMPONENTS.
P850007|S032|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM & SPINAL-STIM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2011|11/02/2011|||OK30|ADDITION OF AN ALTERNATE BATTERY PACK SUPPLIER.
P030034|S006|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL-STIM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2011|11/02/2011|||OK30|ADDITION OF AN ALTERNATE BATTERY PACK SUPPLIER.
P000032|S037|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2011|11/03/2011|||APPR|APPROVAL FOR A MANUFACTURING SITES LOCATED AT COOPERSURGICAL, INC. IN TRUMBULL, CONNECTICUT AND LONE STAR MEDICAL PRODUCTS IN STAFFORD, TEXAS.
P950037|S099|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS FAMILIES/MODELS OF TILDA BRADYCARDIA PACING LEADS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/03/2011|12/02/2011|||APPR|APPROVAL FOR ADDITIONAL TRADE NAMES FOR THE SELOX, SETROX AND COROX FAMILIES OF PACING LEADS.
P070008|S027|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VARIOUS FAMILIES/MODELS OF CELERITY CRT PACING LEADS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/03/2011|12/02/2011|||APPR|APPROVAL FOR ADDITIONAL TRADE NAMES FOR THE SELOX, SETROX AND COROX FAMILIES OF PACING LEADS.
P960058|S092|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2011|10/26/2011|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO IMPROVE AN INSERTION TOOL AND TO DOCUMENT A CHANGE IN THE TOOL SUPPLIERS.
P040027|S025|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2011|10/27/2011|||OK30|FINAL PRODUCT ASSEMBLY AT THE FIRMS PHOENIX LOCATION.
P000040|S020|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/2011|01/24/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE GENESYS HTA SYSTEM CONTROL UNIT.
P960009|S128|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC 37085 EXTENSION|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2011|11/03/2011|||OK30|ADDITION OF A QUALITY TEST TO THE MANUFACTURING PROCESS.
P010032|S043|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2011|11/03/2011|||OK30|IMPLEMENT A NEW POUCH SEALER TO SEAL ALL TERMINALLY STERILIZED POUCHES.
P000058|S047|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2011|08/30/2013|||APPR|APPROVAL FOR NEW REFERENCE STANDARD.
P050053|S023|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2011|08/30/2013|||APPR|APPROVAL FOR NEW REFERENCE STANDARD.
P000054|S032|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2011|08/30/2013|||APPR|APPROVAL FOR NEW REFERENCE STANDARD.
P960009|S129|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|7426 SOLETRA IMPLANTABLE NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2011|11/03/2011|||OK30|CHANGE TO THE CLEANING PROCESS.
P000014|S024|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2011|11/10/2011|||APPR|APPROVAL FOR THE CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
P000044|S028|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG ASSAY AND HBSAG CONFIRMATORY KIT|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2011|11/10/2011|||APPR|APPROVAL FOR THE CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
P020014|S036|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2011|04/19/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRECISION WIRE COMPONENTS, TUALATIN, OREGON.
P010021|S021|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY|MZO|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2011|11/10/2011|||APPR|APPROVAL FOR CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
P030024|S017|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2011|11/10/2011|||APPR|APPROVAL FOR THE CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
P030026|S024|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM ASSAY|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2011|11/10/2011|||APPR|APPROVAL FOR THE CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
P980035|S245|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2011|11/22/2011|||APPR|APPROVAL FOR AN UPDATE TO THE HYBRID DESIGN AND PROTECTION INTEGRATED CIRCUITS APPROVED UNDER THE REFERENCED PMA.
P050045|S003|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion|TOP2A FISH PHARMDX KIT|NXG|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2011|11/10/2011|||OK30|ADD AN ALTERNATE SUPPLIER OF TEXAS RED LABELED DCTP NUCLEOTIDE AND TO REPLACE AN IN-PROCESS QC PROCEDURE WITH A NEW QC TEST ON FFPE BREAST CANCER TISSUE.
P900023|S052|ABIOMED CARDIOVASCULAR, INC.|22 CHERRY HILL DRIVE||DANVERS|MA|01923||Ventricular (assisst) bypass|ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/2011|06/26/2012|||APPR|APPROVAL FOR CORRECTION OF THE AB5000 DRIVER FAILURE NOTIFICATION ALARM, ADDITION OF A DELAY CIRCUIT TO THE EXTERNAL AB PORTABLE POWER SUPPLY, AND CORRECTION TO THE IPULSE DRIVER PLENUM SEAL.
P980016|S324|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2011|11/03/2011|||OK30|AUTOMATIC DATA ENTRY DURING WAFER TESTING.
P010015|S141|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P & SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2011|11/03/2011|||OK30|AUTOMATIC DATA ENTRY DURING WAFER TESTING.
P010031|S278|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II/PROTECCTA/PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2011|11/03/2011|||OK30|AUTOMATIC DATA ENTRY DURING WAFER TESTING.
P090013|S041|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2011|11/03/2011|||OK30|AUTOMATIC DATA ENTRY DURING WAFER TESTING.
P980035|S246|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2011|11/03/2011|||OK30|AUTOMATIC DATA ENTRY DURING WAFER TESTING.
P050039|S007|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2011|04/27/2012|||APPR|APPROVAL FOR USE OF AN ADDITIONAL PACKAGE SEALER FOR THE ACETABULAR LINER AND FEMORAL HEAD STERILE BARRIER PACKAGING PROCESSES.
P010047|S014|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2011|11/10/2011|||OK30|MODIFICATIONS IN AN INSPECTION PROCESS.
P810031|S041|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV & HEALON 5 PRODUCTS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2011|11/03/2011|||OK30|CHANGE IN THE ANTI- BLOCKING ADDITIVE IN THE BLISTER TRAYS.
P020018|S040|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT|MIH|CV|Panel Track|Change Design/Components/Specifications/Material|Y|10/07/2011|04/04/2012|12M-0371|04/17/2012|APPR|APPROVAL FOR THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (WITH THE ADJUNCTIVE ZENITH ALIGNMENT STENT).  THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OFPATIENTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH REQUIRED INTRODUCTION SYSTEMS;2) NONANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSMS WITH: A) LENGTH >= 4 MM AND UNSUITABLE FOR A NON-FENESTRATED GRAFT. B) DIAMETER <= 31 MM AND >= 19 MM. C) ANGLE < 45 DEGREES RELATIVE TO LONG AXIS OF ANEURYSM. D) ANGLE < 45 DEGREES RELATIVE TO AXIS OF SUPRARENAL AORTA.  3) IPSILATERAL ILIAC ARTERY FIXATION SITE > 30 MM IN LENGTH AND BETWEEN 9 - 21 MM IN DIAMETER; AND CONTRALATERAL ILIAC ARTERY DISTAL FIXATION SITE > 30 MM IN LENGTH AND BETWEEN 7 - 21 MM IN DIAMETER.  THE ZENITH ALIGNMENT STENT IS INDICATED FOR USE AS AN ADJUNCT TO THE ZENITH FENESTRATED AAAENDOVASCULAR GRAFT TO SECURE POSITIVE ALIGNMENT OF FENESTRATIONS OR SCALLOPS WITH THE ORIFICE OF AORTIC BRANCH VESSELS HAVING DIAMETERS RANGING FROM 3 TO 8 MM.
P020004|S066|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2011|10/27/2011|||OK30|UPDATE IN BACTERIAL ENDOTOXIN TESTING SOFTWARE.
P040027|S026|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2011|10/27/2011|||OK30|UPDATE IN BACTERIAL ENDOTOXIN TESTING SOFTWARE.
P040037|S038|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2011|10/27/2011|||OK30|UPDATE IN BACTERIAL ENDOTOXIN TESTING SOFTWARE.
P040043|S043|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2011|10/27/2011|||OK30|UPDATE IN BACTERIAL ENDOTOXIN TESTING SOFTWARE.
P050006|S024|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2011|10/27/2011|||OK30|UPDATE IN BACTERIAL ENDOTOXIN TESTING SOFTWARE.
P910001|S050|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS EXCIMER LASER|LPC|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/07/2011|12/06/2011|||APPR|APPROVAL TO IMPLEMENT A CHANGE TO THE RADIO FREQUENCY (RF) ABSORPTION MATERIALS FOR THE CVX-300P MODEL EXCIMER LASER.
P000008|S026|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/11/2011|12/09/2011|||APPR|APPROVAL FOR AN ALTERNATE HUB MATERIAL ON THE 3.5 INCH AND 2.0 INCH ACCESS PORT NEEDLES USED WITH THE LAP-BAND SYSTEM.
P020018|S041|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FLEX AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/2011|12/14/2011|||APPR|APPROVAL FOR MODIFICATIONS TO THE ANCILLARY COMPONENT¿S DELIVERY SYSTEMS FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT PRODUCT LINE.
P050016|S008|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|11/10/2011|||OK30|MODIFICATION TO THE TYPE OF MANUFACTURING PROCESS FOR THE DEVICE.
P970003|S139|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM PULSE GENERATORS|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|11/09/2011|||OK30|CHANGE TO THE WELDING PARAMETERS FOR THE VNS PULSE GENERATORS.
P090028|S001|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK & CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|10/21/2011|||OK30|CONVERSION OF THE IN-PROCESS LIMIT FOR THE PROCESS CONTROL OF THE SELLING CALIBRATOR FROM A SIGNAL RATIO TO A NUMERICAL TEST RESULT.
P980003|S032|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|11/10/2011|||OK30|CHANGE IN SUPPLIER FOR STERILE CONNECTOR CABLES.
P960009|S130|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|11/10/2011|||OK30|REDUCTION IN SAMPLE SIZE FOR INCOMING VISUAL INSPECTION OF MEDICAL ADHESIVE TUBES.
P840001|S197|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|11/10/2011|||OK30|MEDTRONIC, INC.MINNEAPOLIS, MN55432	UPDATE DATA ENTRY DURING THE WAFER TEST PROCESS FROM A MANUAL TO AN AUTOMATED PROCESS.
P860004|S160|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED FAMILY OF INFUSION SYSTEMS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|11/10/2011|||OK30|MEDTRONIC, INC.MINNEAPOLIS, MN55432	UPDATE DATA ENTRY DURING THE WAFER TEST PROCESS FROM A MANUAL TO AN AUTOMATED PROCESS.
P960009|S131|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|11/10/2011|||OK30|MEDTRONIC, INC.MINNEAPOLIS, MN55432	UPDATE DATA ENTRY DURING THE WAFER TEST PROCESS FROM A MANUAL TO AN AUTOMATED PROCESS.
P070015|S081|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|10/28/2011|||OK30|AUTOMATED PROCESS FOR PREPARATION OF THE ADAPTION CUP.
P020047|S040|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|10/28/2011|||OK30|AUTOMATED PROCESS FOR PREPARATION OF THE ADAPTION CUP.
P970020|S069|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTILINK ZETA & ULTRA CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2011|10/28/2011|||OK30|AUTOMATED PROCESS FOR PREPARATION OF THE ADAPTION CUP.
P990012|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG (HBSAG) TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/2011|03/19/2012|||APPR|APPROVAL FOR THE EXTENSION OF THE ELECSYS HBSAG IMMUNOASSAY AND ELECSYS HBSAG CONFIRMATORY TEST ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER.
P010054|S017|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS (ANTI-HBS) TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/2011|04/23/2012|||APPR|APPROVAL FOR THE EXTENSION OF THE ELECSYS ANTI-HBS TEST SYSTEM ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE ELECSYS ANTI-HBS TEST SYSTEM AND IS INDICATED FOR:  ELECSYS ANTI-HBS IMMUNOASSAY -  IMMUNOASSAY FOR THE IN VITRO QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (EDTA).  THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010, MODULAR ANALYTICS E170 (ELECSYS MODULE), COBAS E 411, COBAS E 601, AND COBAS E 602 IMMUNOASSAY ANALYZERS.  ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN.  ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.
P080025|S022|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MODEL 3058 INTERSTIM II NEUROSTIMULATOR|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/12/2011|02/10/2012|||APPR|APPROVAL FOR DESIGN AND SPECIFICATION CHANGES TO THE MODEL 3058 INTERSTIM II BATTERY.
P820033|S008|Asahi Kasei Medical Co., Ltd.|1-105 KANDA JINBOCHO|CHIYODA-KU|TOKYO||101-8|8101|Separator for therapeutic purposes, membrane automated blood cell/plasma|PLASMAFLO OP-05W (A)|MDP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2011|11/02/2011|||OK30|MOVING THE PLASMAFLO MANUFACTURING EQUIPMENT TO A NEW FACILITY LOCATED WITHIN THE CURRENT MANUFACTURING SITE.
P100023|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2011|10/28/2011|||OK30|MODIFICATION TO THE SAMPLING PLAN FOR THE LASER CUTTING SET UP.
P040002|S034|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDOLUMINAL PROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2011|11/04/2011|||OK30|INCLUSION OF AN ADDITIONAL STORAGE FACILITY.
P100014|S004|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/13/2011|10/27/2011|||APPR|APPROVAL OF THE POST-APPROVAL PROTOCOL.
P070022|S024|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|10/13/2011|11/23/2011|||APPR|APPROVAL FOR A CHANGE TO THE ADIANA CATHETER TO INCREASE THE FLEXIBILITY FOR USE WITH HYSTEROSCOPES WITH ARTICULATING TIPS.
P900033|S021|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)|MDD|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2011|05/24/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH AST, LLC IN DENVER, COLORADO.
N18286|S023|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2011|03/06/2012|||APPR|APPROVAL FOR UPDATE ON THE MANUFACTURING SITE INFORMATION AND SYMBOLS ON THE LABELS.
P860004|S161|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2011|02/16/2012|||APPR|APPROVAL FOR AUTOMATING THE TRANSFER OF ENDOTOXIN TESTING DATA INTO THE FACTORY WORKS EXECUTION SYSTEM.
P040014|S018|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2011|11/10/2011|||OK30|ADDITION OF AN ADDITIONAL VENDOR TO ASSEMBLE PRINTED CIRCUIT BOARDS.
P040042|S023|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CARDIAC ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2011|11/10/2011|||OK30|ADDITION OF AN ADDITIONAL VENDOR TO ASSEMBLE PRINTED CIRCUIT BOARDS.
P060019|S019|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2011|11/10/2011|||OK30|ADDITION OF AN ADDITIONAL VENDOR TO ASSEMBLE PRINTED CIRCUIT BOARDS.
P060008|S080|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2011|10/31/2011|||OK30|PROCESS SETTINGS TO BE OPTIMIZED OR DEFINED FOR EXTRUSION OF THE PROXIMAL OUTER COMPONENT.
P040016|S080|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (FORMERLY LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2011|10/31/2011|||OK30|PROCESS SETTINGS TO BE OPTIMIZED OR DEFINED FOR EXTRUSION OF THE PROXIMAL OUTER COMPONENT.
P020009|S079|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2011|10/31/2011|||OK30|PROCESS SETTINGS TO BE OPTIMIZED OR DEFINED FOR EXTRUSION OF THE PROXIMAL OUTER COMPONENT.
P000025|S057|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/14/2011|04/30/2012|||APPR|APPROVAL FOR THE FOLLOWING: 1) +FLEX28, +FLEX24 AND FLEX24 ELECTRODE VARIANTS FOR THE SONATATI100 AND MIL000 MED-EL CONCERT COCHLEAR IMPLANTS; 2) +STANDARD, +MEDIUM AND +COMPRESSED ELECTRODE VARIANTS FOR THE SONATATI100 COCHLEAR IMPLANT; AND 3) NEW VARIANTS OF THE SINGLE USE SURGICAL INSERTION ELECTRODE TOOL (STANDARD, MEDIUM,COMPRESSED, FLEX24 AND FLEX28).
P000025|S058|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/2011|11/21/2012|||APPR|APPROVAL FOR THE MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT.
P980024|S006|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2011|02/27/2012|||APPR|APPROVAL FOR MANUFACTURING PROCESS CHANGES TO THE PATHVYSION HER-2 DNA PROBE KIT, INCLUDING CHANGES ASSOCIATED WITH FISH PROBE RESTRICTION ENZYMEDIGESTED GEL ELECTROPHORESIS (DNA RESTRICTION ANALYSIS), IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR A260 ABSORBANCE READINGS, ADDITION OF AN INCOMING SCREENING TEST FOR DEXTRAN SULFATE AND REVISION TO MANUFACTURING PROCEDURE DOCUMENT FOR LSI HER-2/NEU AMINATED DNA.
P050012|S042|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN & SEVEN PLUS SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2011|04/18/2012|||APPR|APPROVAL OF AN ADDITIONAL SUPPLIER MANUFACTURING FACILITY AT FLEXTRONICS TECHNOLOGY (SHENZHEN), AT GUSHU.
P000025|S059|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COCHLEAR IMPLANT SYSTEMS|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2011|12/16/2011|||APPR|APPROVAL FOR THE OPUS 2 BATTERY PACK XS WHICH IS AN ADDITIONAL OPTIONAL BATTERY PACK FOR USE WITH THE FOLLOWING APPROVED AUDIO PROCESSORS OF THE MED-EL COCHLEAR IMPLANT (CI) SYSTEM: TEMPO+, OPUS 1 AND OPUS 2.
P050006|S025|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2011|11/04/2011|||OK30|REPLACEMENT OF EQUIPMENT FOR MEASURING FIBER DIAMETER.
P990045|S011|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2011|11/15/2011|||OK30|SECOND VENDOR OF CHROMOGEN/ SUBSTRATE BULK SOLUTION.
P990041|S013|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2011|11/15/2011|||OK30|SECOND VENDOR OF CHROMOGEN/ SUBSTRATE BULK SOLUTION.
P990044|S011|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2011|11/15/2011|||OK30|SECOND VENDOR OF CHROMOGEN/ SUBSTRATE BULK SOLUTION.
P990042|S010|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2011|11/15/2011|||OK30|SECOND VENDOR OF CHROMOGEN/ SUBSTRATE BULK SOLUTION.
P990038|S014|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS KIT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2011|11/15/2011|||OK30|SECOND VENDOR OF CHROMOGEN/ SUBSTRATE BULK SOLUTION.
N16895|S094|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2011|05/02/2014|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR THE RAW MATERIAL HYDROXYETHYL-METHYL-METHACRYLATE FOR POLYMACON AND ALPHAFILCON A SOFT CONTACT LENSES.
P960022|S009|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2011|05/02/2014|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR THE RAW MATERIAL HYDROXYETHYL-METHYL-METHACRYLATE FOR POLYMACON AND ALPHAFILCON A SOFT CONTACT LENSES.
P070015|S082|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/19/2011|03/13/2012|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE FROM 12 MONTHS TO 24 MONTHS FOR THE DEVICE.
P030023|S001|OPHTEC USA, INC.|6421 CONGRESS AVE., SUITE 112||BOCA RATON|FL|33487||Ring, endocapsular|OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US|MRJ|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/19/2011|12/14/2011|||APPR|APPROVAL FOR A TRADE NAME CHANGE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND IS INDICATED FOR THE STABILIZATION OF WEAKENED, BROKEN OR MISSING ZONULES THAT ARE SUSPECTED OR OBSERVED DURING CATARACT EXTRACTION USING PHACOEMULSIFICATION AND CONTINUOUS CURVILINEAR CAPSULORHEXIS TECHNIQUES IN ADULTS.
P030031|S036|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/19/2011|12/12/2011|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE FROM ONE (1) TO THREE (3) YEARS AND FOR A MINOR CHANGE TO THE THERMOFOAM TRAY USED TO PACKAGE THE DEVICES.
P040036|S027|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT THERMOCOOL MAGNETIC CATHETER|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/19/2011|12/12/2011|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE FROM ONE (1) TO THREE (3) YEARS AND FOR A MINOR CHANGE TO THE THERMOFOAM TRAY USED TO PACKAGE THE DEVICES.
P000058|S048|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2011|07/17/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE IDENTIFIED PRODUCTS.SPECIFICALLY  REQUESTED WAS THE FOLLOWING:  1) AN ADDITIONAL WARNING TO ADDRESS CONCERNS RELATED TO THE USE OF POTENTIAL PATIENTS WITH A SUSPECTED MALIGNANCY; 2) AN ADDITIONAL WARNING RELATED TO DEVICE MIGRATION; 3) A MODIFICATION TO THE PRECAUTION RELATED TO ECTOPIC, HETEROTOPIC AND EXUBERANT BONE FORMATION BY REMOVING THE INITIAL QUALIFYING LANGUAGE: AND 4) A MODIFICATION TO THE DESCRIPTION OF THE RECONSTITUTED RECOMBINANT PROTEIN SOLUTION, I.E., "...COLORLESS TO SLIGHTLY YELLOW..."
P000054|S033|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2011|07/17/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE IDENTIFIED PRODUCTS.SPECIFICALLY YOU REQUESTED THE FOLLOWING:  1) AN ADDITIONAL WARNING TO ADDRESS CONCERNS RELATED TO THE USE OF POTENTIAL PATIENTS WITH A SUSPECTED MALIGNANCY; 2) AN ADDITIONAL WARNING RELATED TO DEVICE MIGRATION; 3) A MODIFICATION TO THE PRECAUTION RELATED TO ECTOPIC, HETEROTOPIC AND EXUBERANT BONE FORMATION BY REMOVING THE INITIAL QUALIFYING LANGUAGE: AND 4) A MODIFICATION TO THE DESCRIPTION OF THE RECONSTITUTED RECOMBINANT PROTEIN SOLUTION, I.E., "...COLORLESS TO SLIGHTLY YELLOW..."
P050006|S026|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2011|10/28/2011|||OK30|ADOPTION OF AN INSTRUCTION FOR SINGLE PIECE FLOW IN THE BOXING OPERATION.
P010030|S031|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WAERABLE DEFIBRILLATOR|MVK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/2011|11/02/2012|||APPR|APPROVAL FOR SEVERAL HARDWARE DESIGN CHANGES AND A SOFTWARE DRIVER UPATE.
P060002|S021|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2011|10/31/2011|||OK30|INTRODUCTION OF AN AUTOMATED LABELING INSPECTION SYSTEM AND INTRODUCTION OF A NEW BARCODE SCAN SYSTEM.
P080007|S008|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2011|10/31/2011|||OK30|INTRODUCTION OF AN AUTOMATED LABELING INSPECTION SYSTEM AND INTRODUCTION OF A NEW BARCODE SCAN SYSTEM.
P070014|S028|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2011|10/31/2011|||OK30|INTRODUCTION OF AN AUTOMATED LABELING INSPECTION SYSTEM AND INTRODUCTION OF A NEW BARCODE SCAN SYSTEM.
P910073|S099|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE 4-SITE IS-4 LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2011|11/18/2011|||OK30|CHANGE TO THE SETUP POSITION IN A SEAL TEST.
P960058|S093|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/21/2011|03/12/2012|||APPR|APPROVAL OF AN OPTIONAL NOISE REDUCTION ALGORITHM CALLED CLEARVOICE.  CLEARVOICE IS A MODIFIED VERSION OF THE APPROVED FIDELITY 120 SOUND PROCESSING STRATEGY.
P970003|S140|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2011|12/20/2011|||APPR|APPROVAL FOR : 1) REMOVAL OF THE CR10 AND CR11 TVS DIODES FROM THE PCBA DESIGN; AND 2) A CHANGE TO THE PRINTED CIRCUIT BOARD (PCB) SPECIFICATION TO ACCEPT VIAS (VERTICAL ELECTRICAL CONNECTIONS BETWEEN DIFFERENT LAYERS OF CONDUCTORS ON A PCB) FILLED WITH EPOXY FROM THE PCB VENDOR, WHICH IS CURRENTLY ALLOWED FOR THE MODEL 103/104 PULSE GENERATORS.
P980022|S099|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SOFTWARE SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2011|12/20/2011|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES MMT-7333 V5.7A FOR USE WITH THE MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM.
P930029|S034|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONTACTR, RF CONDUCTR, RF MARINR, RF MARINR 5FR AND RF ENHANCER II FAMILIES OF ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2011|11/14/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR VARIOUS COMPONENTS.
P850089|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SP/SP/Z NOVUS/VITATRON IMPULSE II/EXCELLENCE S+/IMPLUSE|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P830061|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SP NOVUS/VITATRON CRYSTALLINE/EXCELLENCE +/PS+|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P980016|S325|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CAPSURE FIX|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P010015|S142|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN OTW|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P080006|S035|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P950024|S037|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPI|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P930039|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX NOVUS/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P920015|S083|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE /S/SPRINT|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P090013|S042|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX NOVUS|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P890003|S237|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD-2/CAPSURE BRILLIANT S+|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|04/06/2012|||APPR|APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS.
P860008|S020|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ESOPHAGEAL PACING SYSTEM|LPA|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|03/06/2012|||APPR|APPROVAL FOR AUTOMATING THE CNC MILLING PROCESS AND THE ADDITION OF A NEW INSPECTION MOLDING MACHINE.
P070015|S083|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|11/15/2011|||OK30|REDUCTION IN THE FREQUENCY OF MONITORING A MANUFACTURING PROCESS TEMPERATURE.
P960043|S076|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM & PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|11/23/2011|||OK30|REPLACEMENT OF ANCILLARY OVERMOLDING PRESS EQUIPMENT.
P090018|S014|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2011|03/26/2013|||APPR|APPROVAL FOR REUSABLE SURGICAL ACCESSORIES INCLUDING REUSABLE TRANSDUCER REPLICAS.
P040016|S081|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|10/31/2011|||OK30|AUTOMATED PROCESS FOR PREPARATION OF THE ADAPTION CUP.
P060008|S081|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|10/31/2011|||OK30|AUTOMATED PROCESS FOR PREPARATION OF THE ADAPTION CUP.
P100023|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2011|10/31/2011|||OK30|AUTOMATED PROCESS FOR PREPARATION OF THE ADAPTION CUP.
P980035|S247|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|350 SERIES/ENRHYTHM/SIGMA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2011|11/23/2011|||OK30|CONSOLIDATION OF MANUFACTURING OPERATIONS AND RELATED EQUIPMENT CHANGES AT A SUPPLIER¿S LOCATION.
P990001|S098|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON DA+C & T SERIES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2011|11/23/2011|||OK30|CONSOLIDATION OF MANUFACTURING OPERATIONS AND RELATED EQUIPMENT CHANGES AT A SUPPLIER¿S LOCATION.
P010015|S143|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2011|11/23/2011|||OK30|CONSOLIDATION OF MANUFACTURING OPERATIONS AND RELATED EQUIPMENT CHANGES AT A SUPPLIER¿S LOCATION.
P090013|S043|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2011|11/23/2011|||OK30|CONSOLIDATION OF MANUFACTURING OPERATIONS AND RELATED EQUIPMENT CHANGES AT A SUPPLIER¿S LOCATION.
P910023|S277|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2011|11/23/2011|||OK30|ADDITION OF A DEVICE LEVEL TEST WITHIN THE CURRENT SUITE OF AUTOMATED MANUFACTURING TESTS.
P030054|S204|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2011|11/23/2011|||OK30|ADDITION OF A DEVICE LEVEL TEST WITHIN THE CURRENT SUITE OF AUTOMATED MANUFACTURING TESTS.
P040024|S055|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|04/23/2012|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGE TO LABEL CHECK CRITERIA;2) EXTENSION OF COMPRESSED AIR DISTRIBUTION IN BUILDING 9 (PHASE 2);  3) SEALING OF VESSELS AFTER CLEAN OUT OF PLACE (COP) USING STERIKING POUCH;  4) CHANGED SAMPLING PROCEDURE FOR BIOBURDEN AND BACTERIAL ENDOTOXINS TESTS;  5) NEW SILICONIZATION AND LUER LOCK ADAPTOR ASSEMBLY PROCESSES 1ML GLASS SYRINGE AT BD;  6) TIGHTENING OF ANALYTICAL ACCEPTANCE LIMITS FOR HA CONTENT AND GEL CONTENT. CHANGEINVOLVES MODIFICATION OF ACCEPTANCE CRITERIA FOR INCOMING RAW MATERIAL, FOR A CRITICAL COMPONENT;7) TIGHTENING LIMITS FOR LIDOCAINE IN PROCESS CONTROL AND CHANGING FROM A CALCULATED TO AFIXED AMOUNT OF ADDED WATER FOR INJECTION (WFI); AND8) INSTALLATION OF NEW DIFFERENTIAL PRESSURE SENSORS.
P990046|S025|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|MEDTRONIC OPEN PIVOT HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2011|11/15/2011|||OK30|ADDITIONAL SUPPLIER OF DEVICE COMPONENT SUBASSEMBLIES.
P970051|S088|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/26/2011|12/20/2011|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE APPROVED CP800 SERIES COIL TO ACCOMMODATE THE MAGNET STRENGTH OF 6 THAT IS HIGHER THAN THE STRENGTHS CURRENTLY AVAILABLE.
P950029|S064|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY & ESPRIT SR/DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2011|11/23/2011|||OK30|IMPLEMENTATION OF AN ALTERNATE MANUFACTURING EQUIPMENT.
P980035|S248|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2011|11/23/2011|||OK30|UPDATES TO A FINAL FUNCTIONAL TEST APPLICATION.
P010015|S144|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA & SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2011|11/23/2011|||OK30|UPDATES TO A FINAL FUNCTIONAL TEST APPLICATION.
P950032|S065|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2011|11/22/2011|||OK30|IMPLEMENTATION OF AN ALTERNATE VENDOR.
P050044|S021|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/2011|10/11/2013|||APPR|APPROVAL FOR A NEW VERSION OF VITAGEL WHERE THE BOVINE THROMBIN COMPONENT IS REPLACED WITH RECOMBINANT HUMAN THROMBIN. THE PRODUCT, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
P930016|S036|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER & WAVESCAN WAVEFRONT SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|11/17/2011|||OK30|ADDITION OF A NEW CAPACITOR AND A REPLACEMENT MICROSCOPE TUBE.
P080023|S010|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|12/01/2011|||OK30|MODIFICATION TO THE BIOBURDEN TEST.
P050042|S014|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|12/01/2011|||OK30|MODIFICATION TO THE BIOBURDEN TEST.
P080023|S011|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|03/02/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE BIOBURDEN TEST.
P060035|S011|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|03/02/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE BIOBURDEN TEST.
P060035|S012|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|12/01/2011|||OK30|MODIFICATION TO THE BIOBURDEN TEST.
P980022|S100|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK TRANSMITTER (MMT-7703), IPRO DIGITAL RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741)|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|10/28/2011|07/06/2012|||APPR|APPROVAL FOR AN INCREASE IN BATTERY LEAD WIRE LENGTH AND TOLERANCES, AND INCREASE WIRE STRIPPING TOLERANCES TO MATCH WITH THE WIRE STRIP TOOL CAPABILITIES AFFECTING THE MINILINK TRANSMITTER (MMT-7703), CGMS IPRO RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, IPRO AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P060002|S022|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|11/17/2011|||OK30|ADDITION OF A NEW SYSTEM TO MONITOR ENVIRONMENTAL CONTROLS.
P080007|S009|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|E-LUMINEXX VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|11/17/2011|||OK30|ADDITION OF A NEW SYSTEM TO MONITOR ENVIRONMENTAL CONTROLS.
P070014|S029|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2011|11/17/2011|||OK30|ADDITION OF A NEW SYSTEM TO MONITOR ENVIRONMENTAL CONTROLS.
P030054|S205|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2011|11/23/2011|||OK30|ALTERNATE AUTOMATED INSPECTION METHOD FOR VERIFICATION OF CONNECTOR SEAL INTEGRITY.
P910023|S278|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2011|11/23/2011|||OK30|ALTERNATE AUTOMATED INSPECTION METHOD FOR VERIFICATION OF CONNECTOR SEAL INTEGRITY.
P900060|S047|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2011|11/29/2011|||OK30|ALTERNATE CARBON COATING PROCESS FOR CPHV SEWING CUFF MANUFACTURING.
P980049|S066|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR & DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2011|11/30/2011|||OK30|USE OF AN ALTERNATE REFLOW OVEN WITH AN UPDATED REFLOW SOLDERING PROFILE AND AN ALTERNATE COMPONENT CARRIER.
P060027|S033|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2011|11/30/2011|||OK30|USE OF AN ALTERNATE REFLOW OVEN WITH AN UPDATED REFLOW SOLDERING PROFILE AND AN ALTERNATE COMPONENT CARRIER.
P080011|S006|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2011|11/29/2011|||OK30|CHANGE IN THE STABILITY SHELF LIFE PROTOCOL.
P980022|S101|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CGMS GOLD MONITOR (MMT-7102W)|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2011|12/28/2011|||APPR|APPROVAL FOR THE GLASS-LIDDED CRYSTAL TO BE REPLACED WITH A CERAMIC LIDDED CRYSTAL ON THE DIGITAL BOARD IN THE GOLD MONITOR (MODEL MMT-7102W), WHICH IS A COMPONENT OF THE DEVICE.
P850079|S051|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY 55/58 UV/XCEL/EXPRESSIONS COLORS/ACCENTS/HYDRASOFT (METHAFILCON A & METHAFILCON B) SOFT (HYDROPHILIC) CONTACT|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2011|11/29/2011|||OK30|CHANGE IN THE STABILITY OF SHELF LIFE PROTOCOL.
P890023|S018|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2011|11/29/2011|||OK30|CHANGE IN THE STABILITY SHELF LIFE PROTOCOL.
P040002|S035|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2011|12/06/2011|||APPR|APPROVAL FOR A MODIFIED CONTRALATERAL LIMB SUREPASS GUIDEWIRE HOLDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX AAA ENDOVASCULAR SYSTEM AND IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA.
P070026|S004|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2011|04/02/2013|13M-0462|04/24/2013|APPR|APPROVAL FOR DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM. THIS DEVICE IS INDICATED FOR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY TOTAL HIP REPLACEMENT SURGERY FOR REHABILITATIONOF HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ANY OF ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS, AVASCULAR NECROSIS, AND POST-TRAUMATIC ARTHRITIS.
P880086|S211|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2011|05/07/2012|||APPR|APPROVAL FOR LEAD FAILURE DETECTION AND TELEMETRY ENHANCEMENTS.
P030035|S089|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2011|05/07/2012|||APPR|APPROVAL FOR LEAD FAILURE DETECTION AND TELEMETRY ENHANCEMENTS.
P880006|S075|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2011|05/07/2012|||APPR|APPROVAL FOR LEAD FAILURE DETECTION AND TELEMETRY ENHANCEMENTS.
P970013|S044|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2011|05/07/2012|||APPR|APPROVAL FOR LEAD FAILURE DETECTION AND TELEMETRY ENHANCEMENTS.
P030054|S206|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF/QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2011|05/07/2012|||APPR|APPROVAL FOR LEAD FAILURE DETECTION AND TELEMETRY ENHANCEMENTS.
P910023|S279|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2011|05/07/2012|||APPR|APPROVAL FOR LEAD FAILURE DETECTION AND TELEMETRY ENHANCEMENTS.
P090008|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY|MZO|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2011|04/25/2012|||APPR|APPROVAL FOR THE EXTENSION OF THE ELECSYS ANTI-HCV IMMUNOASSAY ANDPRECICONTROL ANTI-HCV IMMUNOASSAY ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HCV IMMUNOASSAY AND IS INDICATED FOR:  ELECSYS ANTI-HCV IMMUNOASSAY - THE ELECSYS ANTI-HCV IMMUNOASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETECTION OF TOTAL ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN).  ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE PRESUMPTIVE DIAGNOSIS OF HCV INFECTION IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THIS TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE.  THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON COBAS E 601 AND COBAS E 602 IMMUNOASSAY ANALYZERS.
P090018|S016|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2011|06/22/2012|||APPR|APPROVAL TO ADD NEW, PHYSICALLY SMALLER, SENSOR/ DRIVER MODELS TO THE ESTEEM FAMILY.
P090022|S010|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|05/11/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN PETERSBURG, FLORIDA.
P110019|S001|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|05/07/2012|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS, UK, LIMITED IN DERBYSHIRE, UNITED KINGDOM.
P960058|S094|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2011|04/02/2012|||APPR|APPROVAL FOR A NEW ACCESSORY, CALLED T -COMM, FOR ADVANCED BIONICS BODY-WORN SOUND PROCESSORS. THIS ACCESSORY ALLOWS THE USE OF THE CURRENTLY-APPROVED T-MIC TO BE USED WITH THE BODY-WORN SOUND PROCESSORS. THE T-COMM ALSO INCORPORATES A TELECOIL. A SWITCH ALLOWS THE USER TO SELECT BETWEEN T-MIC, TELECOIL, OR A 50/50 MIX OF THE TWO INPUTS.
P100021|S011|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT II STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2011|04/27/2012|||APPR|APPROVAL FOR A MODIFIED VERSION OF THE ENDURANT STENT GRAFT SYSTEM. THE ENDURANT II STENT GRAFT SYSTEM IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING ADEQUATE ILIAC/FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; PROXIMAL NECK LENGTH OF => 10 MM: INFRARENAL NECK ANGULATION OF =< 60°; DISTAL FIXATION LENGTH OF => 15 MM; AORTIC NECK DIAMETERS WITH A RANGE OF 19-32 MM; ILIAC DIAMETERS WITH A RANGE OF 8-25 MM AND MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR.
P820060|S030|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AXSYM AFP (LN 7A48)|LOK|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|12/22/2011|||APPR|APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
P980007|S023|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|AXSYM FREE PSA (LN 3C20)|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|12/22/2011|||APPR|APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
P910007|S032|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|AXSYM TOTAL PSA (LN 3C19)|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|12/22/2011|||APPR|APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
P970027|S017|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV (LN 5C36)|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|12/22/2011|||APPR|APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
P060003|S011|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM AUSAB (LN 3C74)|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|12/22/2011|||APPR|APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
P060012|S009|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0 (LN 8B88)|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|12/22/2011|||APPR|APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
P060009|S006|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT: 09VB BLDG: AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE-M 2.0 (LN 3B89)|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|12/22/2011|||APPR|APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
P050049|S009|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM HBSAG/CONFIRMATORY (LN 9B01)|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2011|12/22/2011|||APPR|APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
P050023|S048|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2011|05/04/2012|||APPR|APPROVAL FOR THE ADDITION OF WIRELESS TELEMETRY AND PACING VECTOR CHANGES.
P950037|S100|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CYLOS/DR/DR-T/VR/DROMOS DR/SR/SL/KAIROS DR/SR/SL/D/S/PHILOS/DR/DR-T/SR/SLR/D/S/PHILOS II D/DR/S/SLR/SR/DR-T/PROTOS DR/CL|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2011|05/04/2012|||APPR|APPROVAL FOR THE ADDITION OF WIRELESS TELEMETRY AND PACING VECTOR CHANGES.
P000009|S047|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS DR/DR-T/VR/VR-T/LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2011|05/04/2012|||APPR|APPROVAL FOR THE ADDITION OF WIRELESS TELEMETRY AND PACING VECTOR CHANGES.
P070008|S028|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2011|05/04/2012|||APPR|APPROVAL FOR THE ADDITION OF WIRELESS TELEMETRY AND PACING VECTOR CHANGES.
P970003|S141|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2011|12/02/2011|||OK30|ADDITION OF A REWORK STEP FOR SOLDERING OPERATIONS OF LIGHT EMITTING DIODES (LEDS) TO PRINTED CIRCUIT BOARDS (PCBS).
P930038|S069|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2011|11/15/2011|||OK30|ALTERNATE METHOD FOR ENSURING STENT DEPLOYMENT SPECIFICATION REQUIREMENTS.
P090012|S001|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/01/2011|08/08/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910023|S280|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FORTIFY FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|12/01/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P030054|S207|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|12/01/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER.
P980016|S326|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|11/30/2011|||OK30|REMOVAL OF REJECTION CRITERIA AND ASSOCIATED RE-CLEAN PROCESS FOR FLUX BLEED-OUT ON RF MODULES.
P010031|S279|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|11/30/2011|||OK30|REMOVAL OF REJECTION CRITERIA AND ASSOCIATED RE-CLEAN PROCESS FOR FLUX BLEED-OUT ON RF MODULES.
P070009|S014|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|12/02/2011|||OK30|CHANGE IN THE PACKAGING PROCESS.
P950020|S047|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CORONARY FLEXTOME CUTTING BALLOON||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|12/07/2011|||OK30|CHANGE TO THE MANUFACTURING PROCESS EQUIPMENT BY IMPLEMENTING AN ALTERNATE BIOSLIDE COATING MACHINE, WITH UPDATED HARDWARE, SOFTWARE, AND PROCESSING CHANGES, AS WELL AS A MINOR REARRANGEMENT OF THE EXISTING PRODUCTION EQUIPMENT TO NEW LOCATIONS WITHIN THE CURRENT MANUFACTURING LINE.
P000046|S020|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II, OPTIVISC/ANIKAVISC/SODIUM HYALURONATE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|12/21/2011|||OK30|ADDITION OF TWO STABILITY CHAMBERS.
P890003|S238|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR/MODEL 2020A MEDTRONIC CARDIOSIGHT READER/MODEL 2020B CARELINK EXPRES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2011|12/06/2011|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
P840001|S198|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION (SCS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|12/12/2011|||OK30|RELOCATION OF PASSIVATION OPERATIONS AND INTRODUCTION OF AN AUTOMATED FLUID TRANSFER PROCESS WITHIN THE EXISTING MEDTRONIC NEUROMODULATION FACILITY ¿ RICE CREEK CENTRAL.
P860004|S162|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|IMPLANTABLE INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|12/12/2011|||OK30|RELOCATION OF PASSIVATION OPERATIONS AND INTRODUCTION OF AN AUTOMATED FLUID TRANSFER PROCESS WITHIN THE EXISTING MEDTRONIC NEUROMODULATION FACILITY ¿ RICE CREEK CENTRAL.
P960009|S132|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION (DBS)|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2011|12/12/2011|||OK30|RELOCATION OF PASSIVATION OPERATIONS AND INTRODUCTION OF AN AUTOMATED FLUID TRANSFER PROCESS WITHIN THE EXISTING MEDTRONIC NEUROMODULATION FACILITY ¿ RICE CREEK CENTRAL.
P900056|S110|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDWIRE WITH WIRECLIP TORQUER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P920047|S050|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER & CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P980003|S033|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER & CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P020009|S080|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P020025|S032|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER & CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P030025|S094|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P040016|S082|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P060006|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P060008|S082|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P100023|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P960013|S068|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL FAMILY OF LEADS|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/2011|09/13/2012|||APPR|APPROVAL FOR DESIGN CHANGES TO THE HELIX-SHAFT SUBASSEMBLY OF MARKET APPROVED TENDRIL MODELS 1882, 1888, 1988, 2088 AND DURATA MODELS 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, AND 7131 LEADS FOR IMPROVED MANUFACTURABILITY AND COST.
P950022|S079|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA LEADS|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/2011|09/13/2012|||APPR|APPROVAL FOR DESIGN CHANGES TO THE HELIX-SHAFT SUBASSEMBLY OF MARKET APPROVED TENDRIL MODELS 1882, 1888, 1988, 2088 AND DURATA MODELS 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, AND 7131 LEADS FOR IMPROVED MANUFACTURABILITY AND COST.
P040037|S039|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|11/23/2011|||OK30|SOFTWARE UPDATE FOR A TRIMMING SYSTEM.
P900056|S111|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/05/2011|||OK30|ADDITION OF AN ALTERNATE RESIN FOR THE SEALING OF TYVEK TRAY LIDS.
P980022|S102|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK TRANSMITTER/CGMS IPRO RECORDING DEVICE/BATTERY CHARGER|MDS|CH|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|04/30/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTRICON CORPORATION IN  ARDEN HILLS, MINNESOTA.
N18033|S062|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/02/2011|||OK30|CHANGE IN FINISHED GOODS PARAMETER TESTING.
P040045|S028|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|12/02/2011|||OK30|CHANGE IN FINISHED GOODS PARAMETER TESTING.
P860004|S163|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MODEL 855 REFILL KIT|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|04/27/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SURGICAL TECHNOLOGIES, INC. IN SAINT PAUL, MINNESOTA.
P990034|S025|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2011|04/27/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SURGICAL TECHNOLOGIES, INC. IN SAINT PAUL, MINNESOTA.
P860004|S164|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED REFILL KIT/BULK REFILL KIT/SYNCHROMED CATHETER ACCESS PORT (CAP) KIT|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2011|12/07/2011|||OK30|UPDATING OF THE STERILANT ETHYLENE OXIDE RESIDUAL PARAMETER.
P990034|S026|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED REFILL KIT/BULK REFILL KIT/ISOMED CAP KIT|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2011|12/07/2011|||OK30|UPDATING OF THE STERILANT ETHYLENE OXIDE RESIDUAL PARAMETER.
P910018|S015|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/2011|05/03/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE SULFLUX® KP-05 PLASMA SEPARATOR COMPONENT OF THE DEVICE.
P010013|S042|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2011|12/20/2011|||APPR|APPROVAL FOR A CHANGE TO THE NOVASURE TO ADD THE SURESOUND UTERINE SOUND TO THE EXISTING THERMOFORMED TRAY FOR THE NOVASURE DISPOSABLE DEVICE.
P010059|S004|MORCHER GMBH|KAPUZINERWEG 12||STUTTGART, WURTTEMBERG-BADEN||D-703|7037|Ring, endocapsular|EYEJET INJECTOR|MRJ|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/2011|05/23/2013|||APPR|APPROVAL FOR THE EXPANSION OF YOUR FAMILY OF CAPSULAR TENSION RINGS (CTRS) AVAILABLE PRE-LOADED ON THE EYEJET INJECTOR TO INCLUDE NEW CTR MODELS TYPE 10G, 10L, 15, 15A, AND 15B. IN ADDITION, YOU REQUESTED APPROVAL TO SUPPLY CURRENTLY APPROVED CTR TYPE 10C AS PRE-LOADED ON THE EYEJET INJECTOR.
P890003|S239|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MODEL 2090 MEDTRONIC/VITATRON CARELINK PROGRAMMER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2011|12/07/2011|||OK30|MANUFACTURING CHANGES TO ACCOMMODATE AN EQUIVALENT PART ADDITION.
P040023|S019|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/09/2011|12/20/2011|||APPR|APPROVAL FOR VISUAL INSPECTION OF THE DURALOC OPTION POROUS ACETABULAR SHELLS.
P010031|S280|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERT II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II PROTECTA/XT/INSYNC MARQUIS/INSYNC II PROTECT/CONCERTO|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/10/2011|12/06/2011|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
P090013|S044|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/10/2011|12/06/2011|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
P010015|S145|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P & SYNCRA CRT-P|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/10/2011|12/06/2011|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
P980035|S249|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA & ENRHYTHM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/10/2011|12/06/2011|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
P980016|S327|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II SECURA/VIRTUOSO II/INSYNC MARQUIS/VIRTUOSO/PROTECTA|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/10/2011|12/06/2011|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.
P100021|S012|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/10/2011|01/06/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980049|S067|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR & DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2011|12/12/2011|||OK30|ALTERNATE EQUIPMENT FOR THE LASER WELDING PROCESS.
P000013|S011|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/10/2011|11/02/2012|||APPR|APPROVAL FOR LABELING UPDATES INCORPORATING RESULTS OF THE COMPLETED POST-APPROVAL STUDY.
P060027|S034|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2011|12/12/2011|||OK30|ALTERNATE EQUIPMENT FOR THE LASER WELDING PROCESS.
P980040|S037|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (IOL) (MODELS AR40E/AR40E/AR40M/AR40MN) & TECNIS 1 PIECE INTRAOCULAR LENS|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|04/23/2012|||APPR|APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES.
P960028|S035|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|AMO REZOOM INTRAOCULAR LENS (IOL) MODEL NXG1|MFK|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|04/23/2012|||APPR|APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES.
P880081|S037|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO CLARIFLEX INTRAOCULAR LENSES (IOL) ( MODELS CLRFLX/CLRFLXB/CLRFLXC) & TECNIS CL 3-PIECE INTRAOCULAR LENS (IOL)|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|04/23/2012|||APPR|APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES.
P990080|S036|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|AMO TECNIS ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|04/23/2012|||APPR|APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES.
P090018|S017|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/14/2011|||OK30|CHANGE TO THE FINAL SHELF BOX PACKAGING PROCESS FOR THE ESTEEM IMPLANTABLE COMPONENTS.
P980022|S103|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|06/19/2012|||APPR|APPROVAL FOR A MANUFACTURING PROCESS CHANGE TO INCORPORATE THE ADDITION OF PROCESS WATER TO A USED BATCH OF PLATINUM PLATING SOLUTION FOR THE SOF SENSOR GLUCOSE SENSORS (MODELS MMT-7002 AND MMT-7003) THAT ARE COMPONENTS OF THE MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, THE PARADIGM REAL-TIME SYSTEM, THE GUARDIAN REAL-TIME SYSTEM, THE CGMS IPRO SYSTEM AND THE CGMS IPRO2 SYSTEM.
P060006|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/13/2011|||OK30|CHANGE TO THE HEAT SHRINK PROCESSING AID USED TO DELIVER HEAT SHRINK FORCE FOR THE PROXIMAL BOND OF THE CATHETER.
P110019|S002|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/14/2011|01/04/2012|||APPR|APPROVAL TO UPDATE THE LABELING FOR THE XIENCE PRIME  EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO REFLECT AN 18 MONTH SHELF LIFE.
P980023|S046|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2011|02/22/2012|||APPR|APPROVAL FOR THE FOLLOWING: 1) ADDITION OF TRADE NAMES VIGILA AND VOLTA FOR THE LINOX AND LINOX SMART DEFIBRILLATION LEADS; 2) CHANGE TO INDICATIONS FOR USE STATEMENT TO CLARIFY THAT THE VIGILA AND VOLTA LEADS MAYBE USED WITH ANY MANUFACTURERS' ICDS; AND 3) ACCESSORY KITS FOR USE WITH THE VIGILA AND VOLTA LEADS.
P040044|S040|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP VASCULAR CLOSURE DEVICE (6F/7F)|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2011|01/13/2012|||APPR|APPROVAL FOR INTEGRATING THE CATHETER DELIVERY SYSTEM OF THE MYNXCADENCE DEVICE WITH THE HYDROGEL SEALANT OF THE MYNX WITH GRIP TECHNOLOGY DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND ISINDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 6F OR 7F PROCEDURAL SHEATH.
P110011|S001|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT BALLOON LLIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/07/2011|||OK30|CHANGING THE PRODUCT PRINT INFORMATION FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P100023|S028|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/07/2011|||OK30|ADDITION OF AN IN-HOUSE PROCESS FOR CUTTING TUBING MATERIAL.
P080007|S010|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/07/2011|||OK30|THE SURFACE TREATMENT OF THE STENT TO BE PERFORMED AT AN ALTERNATE SUPPLIER AND THE ADDITION OF SEVERAL OPTIMIZATIONS TO THE PROCESS FLOW.
P980035|S250|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/13/2011|||OK30|UPDATED VERSION OF SOFTWARE WHICH SUPPORTS THE HYBRID SLANT HANDLER USED FOR TESTING OF HYBRID SUBASSEMBLIES.
P010031|S281|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/13/2011|||OK30|UPDATED VERSION OF SOFTWARE WHICH SUPPORTS THE HYBRID SLANT HANDLER USED FOR TESTING OF HYBRID SUBASSEMBLIES.
P010015|S146|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P & SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/13/2011|||OK30|UPDATED VERSION OF SOFTWARE WHICH SUPPORTS THE HYBRID SLANT HANDLER USED FOR TESTING OF HYBRID SUBASSEMBLIES.
P090013|S045|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/13/2011|||OK30|UPDATED VERSION OF SOFTWARE WHICH SUPPORTS THE HYBRID SLANT HANDLER USED FOR TESTING OF HYBRID SUBASSEMBLIES.
P980016|S328|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2011|12/13/2011|||OK30|UPDATED VERSION OF SOFTWARE WHICH SUPPORTS THE HYBRID SLANT HANDLER USED FOR TESTING OF HYBRID SUBASSEMBLIES.
P110003|S001|GENZYME CORP.|500 KENDALL STREET||CAMBRIDGE|MA|02142|1562|Occluder, internal vessel, temporary|LEGOO ENDOVASCULAR OCCLUDER|OBC|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2011|03/01/2012|||APPR|APPROVAL FOR A CHANGE TO A STERILIZATION PROCESS PARAMETER.
P980037|S039|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/2011|01/09/2013|||APPR|APPROVAL FOR A NEW DEVICE, THE ANGIOJET ULTRA SYSTEM WITH THE DISTAFLEXTHROMBECTOMY SET WITH A 3 FRENCH DISTAL DIAMETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIOJET ULTRA SYSTEM WITH THE DISTAFLEX THROMBECTOMY SET AND IS INDICATED FOR REMOVING THROMBUS IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC CORONARY ARTERY OR SVG LESIONS IN VESSELS ¿ 2.0 MM IN DIAMETER PRIOR TO BALLOON ANGIOPLASTY OR STENT PLACEMENT.
P840001|S199|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|INJEX MODEL 97791 BUMPY & MODEL 97792 BI-WING ANCHOR KITS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/15/2011|09/06/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC NEUROMODULATION IN MINNEAPOLIS, MINNESOTA.
P870077|S040|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2011|12/12/2011|||OK30|NEW CLEANING METHOD FOR MOLD INSERTS.
P870056|S044|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CAPENTIER-EDWARDS PORCINE BIOPRSTHETIC|DYE|CV|30-Day Notice||N|11/16/2011|12/12/2011|||OK30|NEW CLEANING METHOD FOR MOLD INSERTS.
P860057|S081|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIV VALVES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2011|12/12/2011|||OK30|NEW CLEANING METHOD FOR MOLD INSERTS.
P010041|S028|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS PROCINE STENTLESS BIOPROSTHESTIC VALVES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2011|12/12/2011|||OK30|NEW CLEANING METHOD FOR MOLD INSERTS.
P000007|S027|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2011|12/12/2011|||OK30|NEW CLEANING METHOD FOR MOLD INSERTS.
P020022|S010|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2011|12/23/2013|||APPR|APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE VERSANT HCVRNA 3.0 ASSAY (BDNA) FROM 12 TO 18 MONTHS.
P880047|S018|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2011|12/14/2011|||OK30|ADDITION OF NEW EQUIPMENT.
P050018|S016|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2011|12/20/2011|||OK30|ADDITION OF A SECOND STERILIZATION CYCLE, AND OF NEW EQUIPMENT FOR THE POUCH PEEL STRENGTH PROCESS.
P980016|S330|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA AND PROTECTA XT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2011|12/14/2011|||OK30|MULTIPLE TEST METHOD UPDATES TO A RADIOFREQUENCY TEST APPLICATION.
P010031|S283|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA & PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2011|12/14/2011|||OK30|MULTIPLE TEST METHOD UPDATES TO A RADIOFREQUENCY TEST APPLICATION.
P980035|S252|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/RELIA/SENSIA/VERSA|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2011|10/03/2012|||APPR|APPROVAL FOR REVISIONS TO A TEST PROGRAM USED IN THE MANUFACTURE OF INTEGRATED CIRCUITS.
P970029|S018|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TMR SYSTEM|MNO|CV|30-Day Notice||N|11/17/2011|12/16/2011|||OK30|CHANGES TO THE MANUFACTURING OF THE HANDPIECE DELIVERY SYSTEM.
P920023|S030|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|AMS UROLUME ENDOPROSTHESIS|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2011|12/14/2011|||OK30|CHANGE IN A MEASUREMENT METHOD USED DURING THE POST STERILE PACKAGING OPERATION.
P070006|S007|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT TB TEST|OJN|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2011|11/23/2011|||APPR|APPROVAL FOR THE ADDITION OF A NEW TEST KIT FORMAT WITH INCREASED REAGENT VOLUMES AND 50 ANTIBODY COATED 96-WELL MICROTITRE PLATES TO INCREASE THE KIT CAPACITY TO A TOTAL OF 1200 TESTS.
P110019|S004|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2011|12/07/2011|||OK30|REDUCTION IN FREQUENCY MONITORING OF THE STENT SITE TEMPERATURE.
N12159|S029|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICAL ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2011|12/21/2011|||OK30|ADDITION OF A NEW CUTTER FOR THE SURGICEL ABSORBABLE HEMOSTAT RAW MATERIAL.
P040044|S041|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/19/2011|||OK30|MINOR MODIFICATIONS TO THE HYDROGEL FREEZE-DRYING CYCLE PROCESS.
P040012|S043|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CARTOID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/13/2011|||OK30|CHANGE IN IRRADIATION EQUIPMENT.
P030005|S080|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|RENEWAL TR CRT-P DEVICES|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/05/2011|||OK30|ADDITION OF MULTIPLE PIECES OF MANUFACTURING EQUIPMENT ALREADY IN USE ON OTHER PRODUCT LINES.
P090007|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/14/2011|||OK30|CHANGE TO SCALABLE LOT SIZES IN THE COMPONENT MANUFACTURING PROCESS OF ELECSYS® ANTI-HCV IMMUNOASSAY AND ELECSYS® PRECICONTROL ANTI-HCV AND A CHANGE IN THE LYOPHILISATION PROCESS.
P090008|S007|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY COBAS E 601|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/14/2011|||OK30|CHANGE TO SCALABLE LOT SIZES IN THE COMPONENT MANUFACTURING PROCESS OF ELECSYS® ANTI-HCV IMMUNOASSAY AND ELECSYS® PRECICONTROL ANTI-HCV AND A CHANGE IN THE LYOPHILISATION PROCESS.
P090009|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON MUDULAR ANALYTICS|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/14/2011|||OK30|CHANGE TO SCALABLE LOT SIZES IN THE COMPONENT MANUFACTURING PROCESS OF ELECSYS® ANTI-HCV IMMUNOASSAY AND ELECSYS® PRECICONTROL ANTI-HCV AND A CHANGE IN THE LYOPHILISATION PROCESS.
P030031|S037|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/23/2011|||OK30|ADDITIONAL REWORK PROCESS.
P040036|S028|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT THERMOCOOL MAGNETIC CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/23/2011|||OK30|ADDITIONAL REWORK PROCESS.
P950005|S036|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/23/2011|||OK30|ADDITIONAL REWORK PROCESS.
P980022|S104|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|03/28/2012|||APPR|APPROVAL TO 1) ADD THE BAYER CONTOUR LINK WIRELESS METER TO THE LIST OF METERS, IN THE LABELING, THAT CAN COMMUNICATE WITH THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K); 2) ADD THE BAYER CONTOUR NEXT LINK WIRELESS METER TO THE LIST OF METERS , IN THE LABELING, THAT CAN COMMUNICATE WITH THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), PARADIGM REAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), AND THE GUARDIAN REAL-TIME CONTINUOUS MONITORING SYSTEM (CSS7100, CSS7100K); AND 3) ENABLE THE BAYER CONTOUR NEXT LINK WIRELESS METER TO FACILITATE TRANSFER OF DATA FROM THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), PARADIGM REAL-TIME SYSTEM (MMT-522, MMT -722, MMT -522K, MMT -722K}, AND THE GUARDIAN REAL-TIME CONTINUOUS MONITORING SYSTEM (CSS7100, CSS7100K) TO THE CARELINK THERAPY MANAGEMENT SOFTWARE (MMT-7333, MMT-7335) VIA THE METER USB PORT.
P110001|S002|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2011|12/19/2011|||OK30|ADDITION OF AN AUTOMATED IN-PROCESS VERIFICATION SYSTEM.
P830061|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC CAPSURE LEAD|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE CAPSURE, VITATRON CRYSTALINE, AND VITATRON EXCELLENCE PS+ PACEMAKER LEADS.
P980050|S068|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE TRANSVENE CS/SVC DEFIBRILLATION LEAD.
P980035|S253|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ADAPTA, ADVISA, ENRHYTHM, RELIA, SENSIA, AND VERSA IMPLANTABLE PULSE GENERATORS.
P980016|S331|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTO/PROTECTO XT/SECURA/VIRTUOSO/VIRTUOSO II/PROTECTA XT DR/PROTECTA DR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ENTRUST, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO, VIRTUOSO II, PROTECTA XT DR, AND PROTECTA DR ICDS.
P950024|S038|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE CAPSURE EPICARDIAL PACEMAKER LEAD.
P930039|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIC|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE CAPSURE, SUREFIX, AND VITATRON CRYSTALLINE ACTFIX PACEMAKER LEADS.
P920015|S084|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD ADAPTOR/SPRINT QUATTRO/ SPRINT QUATTRO LEAD/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE SPRINT QUATTRO DEFIBRILLATION LEAD ADAPTORS, SPRINT QUATTRO DEFIBRILLATION LEADS; TRANSVENE SVC DEFIBRILLATION LEAD, AND SUBCUTANEOUS DEFIBRILLATION LEAD.
P900061|S111|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|UNIPOLAR/ LEAD END PIN CAP/OVAL PATCH LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ACCESSORY UPSIZING SLEEVES, LEAD END PIN CAP, AND OVAL PATCH LEAD.
P890003|S240|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE CAPSURE PACEMAKER LEADS, PRODIGY IMPLANTABLE PULSE GENERATORS, AND PACEMAKER SERVICE REPAIR KIT.
P850089|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CASURE/Z NOVUS/ VITATRON IMPULSE II|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE CAPSURE, CAPSURE Z NOVUS, AND VITATRON IMPULSE II PACEMAKER LEADS.
P090013|S047|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE CAPSURE FIX PACEMAKER LEAD AND REVO MRI IMPLANTABLE PULSE GENERATOR.
P080006|S036|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY/ATTAIN ABILITY PLUS/ATTAIN ABILITY STRAIGHT|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ATTAIN ABILITY, ATTAIN ABILITY PLUS, AND ATTAIN ABILITY STRAIGHT LEFT VENTRICULAR LEADS.
P060039|S031|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ATTAIN STARFIX LEFT VENTRICULAR LEAD.
P030036|S037|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE SELECT SECURE PACEMAKER LEADS AND SELECT SECURE ANCHORING SLEEVE.
P010031|S284|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/CONCERTO II/INSYNC III MARQUIS/ INSYNC MAXIMO/MAXIMOII/PROTECTA/PROTECTA XT/PROTECTA CRT-D|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE CONCERTO, CONCERTO II, CONSULTA, INSYNC III MARQUIS, INSYNC MAXIMO, MAXIMO II, PROTECTA, AND PROTECTA XT CRT-DS.
P010015|S148|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN/CONSULTA CRT-P/SYNCRA CRT-P|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2011|02/28/2013|||APPR|APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ATTAIN, CONSULTA, AND SYNCRA CRT-PS.
P000021|S021|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2011|12/15/2011|||OK30|CHANGE IN SUPPLIER FOR DEXTRAN T500 USED IN PRODUCTION OF FLEX REAGENT CARTRIDGES.
P020027|S016|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2011|12/15/2011|||OK30|CHANGE IN SUPPLIER FOR DEXTRAN T500 USED IN PRODUCTION OF FLEX REAGENT CARTRIDGES.
P960016|S038|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC AND SAFIRE ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2011|12/20/2011|||OK30|USER OF AN ADDITIONAL STERILIZATION CHAMBER.
P020052|S009|St. Jude Medical|14901 DEVEAU PLACE||MINNEAPOLIS|MN|55345|2126|SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION|RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER WITH LUMEN|MTE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2011|12/20/2011|||OK30|USER OF AN ADDITIONAL STERILIZATION CHAMBER.
P990056|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2011|12/21/2011|||OK30|CHANGE TO THE INTERMEDIATE STORAGE FORM COATING PROCESS OF THE ELECSYS COATED MICROPARTICLES (BEADS).
P000027|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA IMMUNOASSAY|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2011|12/21/2011|||OK30|CHANGE TO THE INTERMEDIATE STORAGE FORM COATING PROCESS OF THE ELECSYS COATED MICROPARTICLES (BEADS).
P980022|S105|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN REAL-TIME SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2011|04/25/2012|||APPR|APPROVAL FOR A MANUFACTURING LOCATION CHANGE FROM CHINA TO VIETNAM.
P100028|S001|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|STENT, RENAL|FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/06/2011|12/05/2011|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060025|S008|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|3F AORTIC BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2011|12/13/2011|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR FRESH EQUINE PERICARDIAL TISSUE
N18033|S063|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2011|12/15/2011|||OK30|CHANGE TO THE SENSORS.
P040045|S030|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2011|12/15/2011|||OK30|CHANGE TO THE SENSORS.
P010012|S273|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SUTURE SLEEVE ACCESSORY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2011|12/23/2011|||OK30|ADDITION OF AN ALTERNATE SECOND SOURCE SUPPLIER FOR ACCESSORIES TO IMPLANTABLE LEADS.
P940008|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LEAD TERMINAL CAP|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2011|12/23/2011|||OK30|ADDITION OF AN ALTERNATE SECOND SOURCE SUPPLIER FOR ACCESSORIES TO IMPLANTABLE LEADS.
P980035|S254|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2011|12/23/2011|||OK30|UPDATES TO THE TEST SOFTWARE PACKAGES.
P010015|S149|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P/SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2011|12/23/2011|||OK30|UPDATES TO THE TEST SOFTWARE PACKAGES.
P980007|S024|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/23/2011|12/21/2011|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING OF AN INCOMING RAW MATERIAL USED FOR MANUFACTURING THE DEVICE AND IT¿S FINISHED ACCESSORY.
P910007|S033|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/23/2011|12/21/2011|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING OF AN INCOMING RAW MATERIAL USED FOR MANUFACTURING THE DEVICE AND IT¿S FINISHED ACCESSORY.
P060007|S016|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/23/2011|12/21/2011|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.
P050051|S014|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/23/2011|12/21/2011|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.
P060035|S013|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/23/2011|12/21/2011|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.
P080023|S012|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/23/2011|12/21/2011|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.
P050042|S015|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ACHITECT ANTI-HCV|MZO|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/23/2011|12/21/2011|||APPR|APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.
P060037|S015|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN COMPLETE KNEE SOLUTION|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2011|12/23/2011|||OK30|CHANGES TO THE DEVICE CLEANING OPERATIONS.
P020004|S067|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/21/2011|||OK30|ADDITION OF AN ALTERNATE DEPLOYMENT FIBER IN THE MANUFACTURING PROCESS.
P930029|S035|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONTRACTR/RF CONDUCTR/RF MARINR/RF MARINR 5FR/RF ENHANCER II FAMILIES OF ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/23/2011|||OK30|IMPLEMENTATION OF THE NEW ELECTRICAL TEST SYSTEMS.
P830061|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P090013|S048|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P010015|S150|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P030036|S038|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P060039|S032|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P080006|S037|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P850089|S086|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z NOVUS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P890003|S241|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE|NVZ|CV|30-Day Notice||N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P980050|S069|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P950024|S039|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P920015|S085|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO/SUBCUTANEOUS LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P930039|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE/SUREFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/19/2011|||OK30|ADDITION OF A NEW VISION SYSTEM EQUIPMENT CONTROLLER (EC) FIXTURE SYSTEM AS PART OF THE STERILE PACK PROCESS.
P890003|S242|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK PROGRAMMER CRM PROGRAMMER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/25/2011|12/21/2011|||APPR|APPROVAL FOR COMPONENTS CHANGING FROM LEAD-CONTAINING TO LEAD-FREE USED IN THE MEDTRONIC 2090 PROGRAMMER, 5388 DUAL CHAMBER EPG, AND 5348 SINGLE CHAMBER EPG.
P820003|S114|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EPG-SINGLE AND DUAL CHAMBER|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/25/2011|12/21/2011|||APPR|APPROVAL FOR COMPONENTS CHANGING FROM LEAD-CONTAINING TO LEAD-FREE USED IN THE MEDTRONIC 2090 PROGRAMMER, 5388 DUAL CHAMBER EPG, AND 5348 SINGLE CHAMBER EPG.
P980016|S332|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO/VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/23/2011|||OK30|IMPLEMENTATION OF A MANUFACTURING OPERATIONS CONSOLIDATION AND EQUIPMENT CHANGE AT AN APPROVED COMPONENT SUPPLIER.
P010031|S285|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO/CONCERTO II, CONSULTA, MAXIMO II, PROTECTA/PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2011|12/23/2011|||OK30|IMPLEMENTATION OF A MANUFACTURING OPERATIONS CONSOLIDATION AND EQUIPMENT CHANGE AT AN APPROVED COMPONENT SUPPLIER.
P020002|S006|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|REVIEW SCOPE MANUAL|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|11/29/2011|01/23/2012|||APPR|APPROVAL FOR THE REVIEW SCOPE MANUAL+.
P040014|S019|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION SYSTEM|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2011|08/22/2012|||APPR|APPROVAL FOR AN ADDITIONAL VENDOR OF A GENERATOR COMPONENT.
P040042|S024|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CARDIAC ABLATION SYSTEM|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2011|08/22/2012|||APPR|APPROVAL FOR AN ADDITIONAL VENDOR OF A GENERATOR COMPONENT.
P060019|S020|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2011|08/22/2012|||APPR|APPROVAL FOR AN ADDITIONAL VENDOR OF A GENERATOR COMPONENT.
P110010|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Change Design/Components/Specifications/Material|N|11/30/2011|06/01/2012|12M-0562|06/18/2012|APPR|APPROVAL FOR THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
P880086|S212|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|TIERED THERAPY IMPLANTABLE DEFIBRILLATOR|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P970013|S045|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|IMPLANTABLE PACEMAKER PULSE GENERATOR|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P880006|S076|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|IMPLANTABLE CARDIAC PACEMAKER PULSE GENERATOR|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P030035|S090|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P960013|S069|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE|NVN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P960030|S034|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P950022|S080|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|TRANSVENOUS DEFIBRILLATION LEAD|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P030054|S208|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|DEFIBRILLATOR/AUTOMATIC IMPLANTABLE CARDIOVERTER|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P910023|S281|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|TRANSTELEPHONIC FOLLOW-UP/MONITORING SYSTEM|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|04/13/2012|||APPR|APPROVAL FOR CHANGES TO STERILIZATION LOADING CONFIGURATIONS.
P910001|S051|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|02/17/2012|||APPR|APPROVAL FOR THE USE OF A NEW STERILIZATION CHAMBER, NEW STERILIZATION CYCLE, CHANGE IN PACKAGING CONFIGURATION FOR STERILIZATION, AND A CHANGE IN THE STERILE LOAD CONFIGURATION.
P960042|S032|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2011|02/17/2012|||APPR|APPROVAL FOR THE USE OF A NEW STERILIZATION CHAMBER, NEW STERILIZATION CYCLE, CHANGE IN PACKAGING CONFIGURATION FOR STERILIZATION, AND A CHANGE IN THE STERILE LOAD CONFIGURATION.
P110019|S005|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2011|12/30/2011|||OK30|AUTOMATION OF THE EXISTING BALLOON NECKING PROCESS, LEAVING THE CURRENT MANUAL PROCESS AS AN ALTERNATE.
P890057|S020|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|HIGH FREQUENCY OSCILLATING VENTILATOR|LSZ|AN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2011|01/31/2012|||APPR|APPROVAL FOR THE ADDITION OF AN ADHESIVE TO THE WELDED JOINTS OF THE BREATHING CIRCUIT HUB IN THE DEVICE.
P100023|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PLATINUM CHROMIUM PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2011|12/14/2011|||OK30|UPDATE TO THE PORT WELD HEAT SHRINK REMOVAL PROCESS.
P110010|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2011|12/14/2011|||OK30|UPDATE TO THE PORT WELD HEAT SHRINK REMOVAL PROCESS.
P100041|S001|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/02/2011|01/31/2012|||APPR|APPROVAL FOR POST-APPROVAL STUDY PROTOCOL,
P910001|S052|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2011|12/27/2011|||OK30|CHANGE IN EO STERILIZATION PROCESS MONITORING.
P960042|S033|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2011|12/27/2011|||OK30|CHANGE IN EO STERILIZATION PROCESS MONITORING.
P010012|S274|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 3 IS-1 LEADS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/02/2011|03/05/2012|||APPR|APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF OPTINOVA AS  SUPPLIER OF EXTRUDED POLYURETHANE TUBING; 2) MODIFICATION TO DIMENSIONAL TOLERANCES FOR EXTRUDED POLYURETHANE TUBING; 3) MODIFICATION TO POLYURETHANE TUBING SPECIFICATION FOR FOREIGN MATERIAL, BUBBLES, AND GEL INCLUSIONS; AND 4) REMOVAL OF REDUNDANT METHYLENE DIANILINE (MDA) RESIDUAL LEVEL REQUIREMENTS FOR EXTRUDED TUBING,
P050046|S012|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE IS-1 LEADS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/02/2011|03/05/2012|||APPR|APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF OPTINOVA AS  SUPPLIER OF EXTRUDED POLYURETHANE TUBING; 2) MODIFICATION TO DIMENSIONAL TOLERANCES FOR EXTRUDED POLYURETHANE TUBING; 3) MODIFICATION TO POLYURETHANE TUBING SPECIFICATION FOR FOREIGN MATERIAL, BUBBLES, AND GEL INCLUSIONS; AND 4) REMOVAL OF REDUNDANT METHYLENE DIANILINE (MDA) RESIDUAL LEVEL REQUIREMENTS FOR EXTRUDED TUBING.
P970003|S142|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM PULSE GENERATORS|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2011|12/23/2011|||OK30|TWO REVISIONS TO THE SOFTWARE USED IN THE AUTOMATED FUNCTIONAL TEST SYSTEM (AFT) FOR THE VNS THERAPY SYSTEM PULSE GENERATORS.
P910023|S282|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ST JUDE MEDICAL ICDS/CRT-DS AND LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2011|12/30/2011|||OK30|ALTERNATE SUPPLIER FOR THE THIN FILM RESISTOR COMPONENT.
P030054|S209|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ST JUDE MEDICAL ICDS/CRT-DS AND LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2011|12/30/2011|||OK30|ALTERNATE SUPPLIER FOR THE THIN FILM RESISTOR COMPONENT.
P880086|S213|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2011|12/30/2011|||OK30|ALTERNATE SUPPLIER FOR THE THIN FILM RESISTOR COMPONENT.
P030035|S091|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ANTHEM FAMILIES OF CRT-PS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2011|12/30/2011|||OK30|ALTERNATE SUPPLIER FOR THE THIN FILM RESISTOR COMPONENT.
P100041|S002|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/05/2011|04/06/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950042|S007|NOVADAQ TECHNOLOGIES, INC.|2585 SKYMARK AVENUE, STE. 306||MISSISSAUGA, ONTARIO||L4W 4||SYSTEM, IMAGING, FLUORESCENCE|PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA|MRK|EN|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|12/01/2011|02/02/2012|||APPR|APPROVAL FOR A CHANGE IN THE TRADE NAME OF THE MEDICAL DEVICE FROM PINPOINT TO ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA.
P040005|S006|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 FISH PHARMADX KIT|MVD|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/05/2011|06/08/2012|||APPR|APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HER2 FISH PHARMDX KIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HER2 FISH PHARMDX KIT AND ITS INDICATION FOR USE IS: A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TOQUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA.  HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST AND GASTRIC CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED AND FOR BREAST CANCER PATIENTS FOR WHOM PERJETA (PERTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN AND PERJETA PACKAGE INSERTS).
P980018|S015|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEP TEST|MVC|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/05/2011|06/08/2012|||APPR|APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HERCEPTEST. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HERCEPTEST AND ITS INDICATION FOR USE IS: HERCEPTEST IS A SEMI-QUANTITATIVE IMMUNOHISTO-CHEMICAL ASSAY TO DETERMINE HER2 PROTEIN OVEREXPRESSION IN BREAST CANCER TISSUES ROUTINELY PROCESSED FOR HISTOLOGICAL EVALUATION AND FORMALIN-FIXED, PARAFFIN-EMBEDDED CANCER TISSUE FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HERCEPTEST IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST AND GASTRIC CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED AND FOR BREAST CANCER PATIENTS FOR WHOM PERJETA  (PERTUZUMAB) TREATMENT IS BEINGCONSIDERED (SEE HERCEPTIN AND PERJETA PACKAGE INSERTS).
P900066|S011|AIR LIQUIDE HEALTHCARE AMERICA CORPORATION|6141 EASTON ROAD|BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN PERFLUOROPROPANE C3F8 GAS|LPO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2011|01/05/2012|||OK30|REPLACEMENT OF THE ION CHROMATOGRAPH.
P970055|S012|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY|MYM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2011|12/29/2011|||OK30|MANUFACTURING LOCATION AND QC TESTING SEQUENCE CHANGES FOR STREPTAVIDIN-HRP SUBSTRATE.
P100024|S001|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMADX KIT|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|12/07/2011|02/01/2012|||APPR|APPROVAL FOR AN UPDATE OF THE SOFTWARE DOCUMENTATION FOR DAKOLINK SOFTWARE VERSION 3.0 TO DAKOLINK VERSION 3.1.1.
P860004|S166|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCROMED II|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2011|12/28/2011|||OK30|UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER.
P960009|S133|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC/SC/RC/DBS NEUROSTIMULATOR EXTERNAL|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2011|12/28/2011|||OK30|UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER.
P970004|S126|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2011|12/28/2011|||OK30|UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER.
P080025|S023|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2011|12/28/2011|||OK30|UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER.
P840001|S200|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATOR EXTERNAL/RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCED/RESTORESENSOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2011|12/28/2011|||OK30|UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER.
P830055|S122|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2011|02/06/2012|||APPR|APPROVAL FOR THE ADDITION OF TRUMATCH PATIENT SPECIFIC INSTRUMENTS (PATIENT-MATCHED CUTTING/DRILLING GUIDES) AS OPTIONAL INSTRUMENTATION TO USE WITH FEMORAL AND TIBIAL COMPONENTS.
P010032|S044|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON NEUROSTIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2011|01/06/2012|||OK30|ADD A BACKSIDE LAMINATION TO COMPONENTS INSTALLED ON THE PRINTED CIRCUIT BOARD (PCB).
P940015|S024|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC & SYNVISC-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2011|01/05/2012|||OK30|ADDITION OF A LARGER FILLING VESSEL.
P030017|S125|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2011|01/04/2012|||OK30|A NEW FABRICATION SITE FOR THE SUPPLIER OF THE ANALOG INTEGRATED CIRCUIT (IC) IN THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OF THE IMPLANTABLE PULSE GENERATOR (IPG) FOR THE PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM.
P030036|S039|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2011|06/06/2012|||APPR|APPROVAL FOR A NEW LASER WELDER AND UPDATED WELD PARAMETERS.
P950024|S040|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE EPI PACING LEADS|NVN|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|12/09/2011|11/27/2012|||APPR|APPROVAL TO ADD MODEL 4965 POST-APPROVAL STUDY RESULTS TO THE DEVICE LABELING.
P010019|S027|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|O2OPTIX/AIR OPTIX AQUA/AIR OPTIX FOR ASTIGMATISM/AIR OPTIX AQUA MULTIFOCAL|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|01/10/2012|||OK30|AUTOMATION OF THE TRAY TRANSFER SYSTEM.
P980022|S106|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN (MODEL MMT-522/MMT-522K/MMT-722/MMT-722K/MMT-523/MMT-523K/MMT-723/MMT-723K)|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|12/28/2011|||OK30|CHANGE IN MANUFACTURING LOCATION FROM THAILAND TO MOORPARK, CA FOR CTS ELECTRONICS MANUFACTURING SOLUTIONS, INC. (CTS), THE SUPPLIER OF THE PRINTED CIRCUIT BOARD ASSEMBLIES (PCBA), FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K), WHICH ARE COMPONENTS OF THE DEVICE.
P860003|S063|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|01/10/2012|||OK30|CHANGE IN THE TUBE CUTTING PROCESS.
P110020|S003|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|09/04/2012|||APPR|APPROVAL FOR A CHANGE IN THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR CERTAIN VIALED MASTER MIX AND PROBE REAGENT COMPONENTS.
P100020|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|10/18/2012|||APPR|APPROVAL FOR A CHANGE IN THE DNA SYNTHESIZER INSTRUMENT PLATFORM.
P000012|S036|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, V2.0/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|09/18/2012|||APPR|APPROVAL FOR THE MANUFACTURING CHANGES TO THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR THE VIALED MASTER MIX AND PROBE REAGENT COMPONENTS.
P050028|S023|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0|MKT|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|09/18/2012|||APPR|APPROVAL FOR THE MANUFACTURING CHANGES TO THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR THE VIALED MASTER MIX AND PROBE REAGENT COMPONENTS.
P060030|S024|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|09/18/2012|||APPR|APPROVAL FOR THE MANUFACTURING CHANGES TO THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR THE VIALED MASTER MIX AND PROBE REAGENT COMPONENTS.
P100013|S003|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/12/2011|09/19/2012|||APPR|APPROVAL FOR THE PATIENT BROCHURE.
P980049|S068|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|01/11/2012|||OK30|IN-SOURCING OF AN ELECTRONIC ASSEMBLY.
P060027|S035|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2011|01/11/2012|||OK30|IN-SOURCING OF AN ELECTRONIC ASSEMBLY.
P980022|S107|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CARELINK IPRO THERAPY MANAGEMENT SOFTWARE (MODEL, MMT-7340)|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/12/2011|02/06/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE CARELINK IPRO THERAPY MANAGEMENT SOFTWARE (MMT-7340, VERSION 1.4A) FOR USE WITH THE DEVICE.
P960009|S134|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION (DBS) EXTENSION KITS|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/12/2011|02/03/2012|||APPR|APPROVAL FOR REMOVAL OF THE TUNNELING TOOL AND TUNNELING TOOL ACCESSORIES FROM DEEP BRAIN STIMULATION (DBS) EXTENSION KITS, MODELS 7472A AND 37085.
P060008|S083|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2011|05/09/2012|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE MOISTURE ANALYZER.
P040016|S083|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (FORMERLY LIBERTE) CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2011|05/09/2012|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE MOISTURE ANALYZER.
P950020|S048|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|CORONARY FLEXTOME CUTTING BALLOON|NWX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2011|05/09/2012|||APPR|APPROVAL FOR THE USE OF AN ALTERNATE MOISTURE ANALYZER.
P040044|S042|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2011|01/06/2012|||OK30|CHANGE TO THE FREEZE-DRY PROCESS AND EQUIPMENT.
P990046|S026|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|MEDTRONIC OPEN PIVOT HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2011|08/13/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTEST LABORATORIES IN BROOKLYN PARK, MINNESOTA.
P010019|S028|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON B SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2011|05/11/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CIBA VISION IN JOHOR, MALAYSIA.
P840001|S201|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORESENSOR IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2011|01/12/2012|||OK30|THREE SOFTWARE CHANGES, AUTOMATION OF THE BOND PAD ARRAY MANUFACTURING PROCESS, AND MINOR CHANGES TO THE ETHYLENE OXIDE RESIDUAL TESTING PROCEDURES.
P040005|S007|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 IQFISH PHARMDX|MVD|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2011|12/05/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE FORMULATION OF THE HER2 FISH PHARMDX KIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HER2 IQFISH PHARMDX.
P010012|S275|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2011|01/13/2012|||OK30|USE OF A NEW CATHODE MATERIAL IN THE HIGH VOLTAGE CAPACITOR AND A NEW SUPPLIER.
P960040|S247|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2011|01/13/2012|||OK30|USE OF A NEW CATHODE MATERIAL IN THE HIGH VOLTAGE CAPACITOR AND A NEW SUPPLIER.
P090016|S001|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|Normal 180 Day Track No User Fee|Other Report|N|12/14/2011|05/01/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020018|S042|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/10/2012|04/13/2012|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) LABELING.  THE LABELING CHANGES INVOLVED RECOMMENDATIONS TO USERS REGARDING MAINTAINING HEMOSTASIS, USE OF FLUOROSCOPY AND TRIGGER WIRE RELEASE, AND AN ALTERNATIVE SUPRARENAL DEPLOYMENT SEQUENCE.
P060007|S017|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG & HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2011|01/13/2012|||OK30|CHANGE TO A QUALITY CONTROL TEST METHOD USED FOR BIOBURDEN EVALUATION.
P000025|S060|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2011|03/05/2012|||APPR|APPROVAL FOR A CHANGE IN THE TOLERANCE LIMITS FOR THE OPUS 1 SPEECH PROCESSOR FREQUENCY MEASUREMENT DURING FINAL INSPECTION OF THE DEVICE.  THE REASON FOR THE CHANGE IN THE TOLERANCE LIMITS WAS A CHANGE IN THE OPUS 1 MICROPHONE FROM THE ORIGINAL MICROPHONE KNOWLES EG-3000-CX TO THE KNOWLES EG-23000-CX.
P110010|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2011|01/13/2012|||OK30|SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY.
P020045|S041|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2011|01/13/2012|||OK30|STREAMLINING THE INSPECTION PROCEDURE FOR THE FREEZOR FAMILY OF CATHETERS.
P840001|S202|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATIONS LEADS (SCS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2011|01/13/2012|||OK30|ADDITION OF TWO NEW DESKTOP WELDING STATIONS WITH UPDATED POWER SUPPLIES, AND TWO PROCESS CHANGES TO INCLUDE THE CONSOLIDATION OF PRODUCTION LASER WELD PROGRAM CODE AND REDUCING FREQUENCY PARAMETERS FOR THE WELDING PROCESS.
P080025|S024|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM LEADS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2011|01/13/2012|||OK30|ADDITION OF TWO NEW DESKTOP WELDING STATIONS WITH UPDATED POWER SUPPLIES, AND TWO PROCESS CHANGES TO INCLUDE THE CONSOLIDATION OF PRODUCTION LASER WELD PROGRAM CODE AND REDUCING FREQUENCY PARAMETERS FOR THE WELDING PROCESS.
P960009|S135|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION (DBS) LEADS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2011|01/13/2012|||OK30|ADDITION OF TWO NEW DESKTOP WELDING STATIONS WITH UPDATED POWER SUPPLIES, AND TWO PROCESS CHANGES TO INCLUDE THE CONSOLIDATION OF PRODUCTION LASER WELD PROGRAM CODE AND REDUCING FREQUENCY PARAMETERS FOR THE WELDING PROCESS.
P970004|S127|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM LEADS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2011|01/13/2012|||OK30|ADDITION OF TWO NEW DESKTOP WELDING STATIONS WITH UPDATED POWER SUPPLIES, AND TWO PROCESS CHANGES TO INCLUDE THE CONSOLIDATION OF PRODUCTION LASER WELD PROGRAM CODE AND REDUCING FREQUENCY PARAMETERS FOR THE WELDING PROCESS.
P100010|S013|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2011|01/13/2012|||OK30|STREAMLINING THE INSPECTION PROCEDURE FOR THE FREEZOR FAMILY OF CATHETERS.
P010007|S008|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AFP IMMULITE SUBSTRATE REAGENT|LOK|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|04/05/2012|||APPR|APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
P930027|S014|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|PSA IMMULITE SUBSTRATE REAGENT|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|04/05/2012|||APPR|APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
P060005|S007|SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED|GLYN RHONWY. LLANBERIS|CAERNARFON|GWYNEDD, LL55||4EL||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|FPSA IMMULITE SUBSTRATE REAGENT|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|04/05/2012|||APPR|APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
P010051|S011|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBC IMMULITE SUBSTRATE REAGENT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|03/27/2012|||APPR|APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
P010053|S010|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBCM IMMULITE SUBSTRATE REAGENT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|03/27/2012|||APPR|APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
P010050|S015|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|HBSAG IMMULITE SUBSTRATE REAGENT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|03/27/2012|||APPR|APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
P010052|S011|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBS IMMULITE SUBSTRATE REAGENT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|03/27/2012|||APPR|APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE.
P110019|S006|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME/XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|01/18/2012|||OK30|REMOVE REDUNDANT CLEANING AND TREATMENT STEPS AND INCLUDE CLEAN ROOM PROCESS MODIFICATIONS.
P970003|S143|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|01/18/2012|||OK30|CHANGES TO THE PARALLEL GAP WELDING STEP DURING THE MANUFACTURING OF THE LEADS FOR THE DEVICE.
P060001|S016|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|01/18/2012|||OK30|ADDITION OF A 7-PALLET STERILIZER VESSEL AT THE CONTRACT STERILIZER.
P020004|S068|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS CATHETER|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|01/13/2012|||OK30|USE OF ADDITIONAL MANUFACTURING EQUIPMENT FOR LASER CUTTING.
P110012|S001|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT|OWE|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2011|06/07/2012|||APPR|APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR THE HUMAN PLACENTAL (HP) DNA COMPONENT FOR THE DEVICE, PER DESIGN VERIFICATION PROTOCOL MD17892.
P950032|S066|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2011|12/28/2011|||APPR|APPROVAL FOR THE INTRODUCTION OF A NEW FIBROBLAST CELL STRAIN (HDF 167) IN THE COMMERCIAL PRODUCTION OF APLIGRAF.
P940015|S025|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC & SYNVISC-ONE|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|05/03/2012|||APPR|APPROVAL FOR THE ADDITION OF A NEW PRODUCT DATA AND LABORATORY INFORMATION MANAGEMENT SYSTEM.
P030032|S014|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|PREVELLE SILK|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|05/03/2012|||APPR|APPROVAL FOR THE ADDITION OF A NEW PRODUCT DATA AND LABORATORY INFORMATION MANAGEMENT SYSTEM.
P860057|S082|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/19/2012|||OK30|ADDITION OF HAWKINS INC., AS AN ALTERNATE SUPPLIER OF SODIUM CHLORIDE.
P870056|S045|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/19/2012|||OK30|ADDITION OF HAWKINS INC., AS AN ALTERNATE SUPPLIER OF SODIUM CHLORIDE.
P870077|S041|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSUR MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/19/2012|||OK30|ADDITION OF HAWKINS INC., AS AN ALTERNATE SUPPLIER OF SODIUM CHLORIDE.
P000007|S028|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/19/2012|||OK30|ADDITION OF HAWKINS INC., AS AN ALTERNATE SUPPLIER OF SODIUM CHLORIDE.
P010041|S029|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/19/2012|||OK30|ADDITION OF HAWKINS INC., AS AN ALTERNATE SUPPLIER OF SODIUM CHLORIDE.
P100041|S003|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/19/2012|||OK30|ADDITION OF HAWKINS INC., AS AN ALTERNATE SUPPLIER OF SODIUM CHLORIDE.
P980016|S333|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II/VIRTUOSO II/SECURA/PROTECTA XT/PROTECTA/PROTECTA XT/PROTECTA DF4 ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/18/2012|||OK30|IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.
P970012|S090|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400 DR/SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/18/2012|||OK30|IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.
P890003|S243|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODOGY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/18/2012|||OK30|IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.
P980035|S255|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700/800/900/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA/RELIA/ADVISA DR IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/18/2012|||OK30|IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.
P010015|S151|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC/INSYNC III/CONSULTA/SYNERA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/18/2012|||OK30|IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.
P990001|S099|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEMA IPG/C & T SERIES IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/18/2012|||OK30|IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.
P090013|S049|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/18/2012|||OK30|IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.
P010031|S286|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA/PROTECTA XT/PROTECTA/PROTECTA DF4||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2011|01/18/2012|||OK30|IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.
P110010|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/20/2011|05/11/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970008|S060|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2011|02/03/2012|||APPR|APPROVAL FOR MINOR CHANGES TO THE SOFTWARE FOR THE TARGIS SYSTEM COOLWAVE CONTROL UNIT MODEL 5000 AND ASSOCIATED CHANGES TO THE USER MANUAL. THE DEVICE,AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE RELIEF OF SYMPTOMS AND OBSTRUCTIONS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 2.5-3.5CM (SHORT ANTENNA), OR 3.0-5.0CM (STANDARD ANTENNA), OR 4.5+CM (LONG ANTENNA).
P050012|S043|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN & SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/18/2012|||OK30|CHANGE IN A MANUFACTURING FIXTURE USED IN THE ATTACHMENT OF AN ADHESIVE PATCH IN THE SENSOR/APPLICATOR DELIVERY SYSTEM COMPONENT IN THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS. ADDITIONALLY, THE MECHANICAL INSTRON PULL TEST WAS REPLACED WITH A MANUAL ADHESIVE PATCH PULL TEST TO BE USED IN RECEIVING INSPECTION FOR THE DISPOSABLE HOUSING OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P010032|S045|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS/EON/EON C/EON NEUROSTIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/19/2012|||OK30|MANUFACTURING PROCESS CHANGE TO ADD AN IN-PROCESS INSPECTION STEP FOR THE DEVICES.
P030022|S020|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/20/2012|||OK30|CHANGE IN YOUR HIP STEM COATING PROCESS.
P060002|S023|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/18/2012|||OK30|USE OF AN ALTERNATE INK ON THE DELIVERY SYSTEM HANDLE.
P110019|S007|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/18/2012|||OK30|MANUFACTURING CHANGE TO AUTOMATE THE ADAPTION CUP PREPARATION PROCESS.
P890055|S038|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND ACESSORIES|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/17/2012|||OK30|MANUFACTURING PROCESS CHANGE TO THE DEVICE USED WITH THE CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP AND MEDSTREAM PROGRAMMABLE INFUSION PUMP.
P790005|S048|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/20/2012|||OK30|ADDITION OF NEW IN-PROCESS PACKAGE SEAL STRENGTH TESTS.
P070015|S085|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/20/2012|||OK30|ADDITION OF AN ALTERNATE MANUFACTURING SITE FOR DRUG SUBLOTTING AND THE IMPLEMENTATION OF A NEW PIECE OF EQUIPMENT FOR POUCH SEALING.
P110019|S008|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/20/2012|||OK30|ADDITION OF AN ALTERNATE MANUFACTURING SITE FOR DRUG SUBLOTTING AND THE IMPLEMENTATION OF A NEW PIECE OF EQUIPMENT FOR POUCH SEALING.
P010012|S276|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/19/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR A RESISTOR COMPONENT.
P960040|S248|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/19/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR A RESISTOR COMPONENT.
P840001|S203|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|INTREL 3 IMPLANTABLE NEUROSTIMULATORS/SYNERGY/RESTORE FAMILIES OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/20/2012|||OK30|THERMAL PROCESSING OF ECCOBOND EPOXY RESIN E3450(A) PRIOR TO CONSUMPTION IN ROUTINE MANUFACTURING.
P960009|S136|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA/KINETRA NEUROSTIMULATORS/ACTIVA FAMILY OF NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/20/2012|||OK30|THERMAL PROCESSING OF ECCOBOND EPOXY RESIN E3450(A) PRIOR TO CONSUMPTION IN ROUTINE MANUFACTURING.
P970004|S128|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/20/2012|||OK30|THERMAL PROCESSING OF ECCOBOND EPOXY RESIN E3450(A) PRIOR TO CONSUMPTION IN ROUTINE MANUFACTURING.
P080025|S025|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2011|01/20/2012|||OK30|THERMAL PROCESSING OF ECCOBOND EPOXY RESIN E3450(A) PRIOR TO CONSUMPTION IN ROUTINE MANUFACTURING.
P890047|S035|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2011|01/20/2012|||OK30|CHANGES TO THE SYRINGE COMPONENT STERILIZATION PROCESSES.
P840064|S047|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2011|01/20/2012|||OK30|CHANGES TO THE SYRINGE COMPONENT STERILIZATION PROCESSES.
P900067|S007|AIR LIQUIDE|6141 EASTON ROAD|P.O. BOX 310|PLUMSTEADVILLE|PA|18949||Gases used within eye to place pressure on detached retina|ISPAN SULFUR HEXAFLUORIDE SF6 GAS|LPO|OP|30-Day Notice||N|12/22/2011|01/20/2012|||OK30|REPLACE THE ION CHROMATOGRAPH FOR QUALITY CONTROL PRODUCT TESTING.
P050037|S031|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice||N|12/22/2011|05/30/2012|||APPR|APPROVAL FOR A TEST RESULT EVALUATION PROCEDURE.
P050052|S034|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice||N|12/22/2011|05/30/2012|||APPR|APPROVAL FOR A TEST RESULT EVALUATION PROCEDURE.
N17600|S026|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2011|01/23/2012|||APPR|APPROVAL FOR THE ADDITION OF A PRECAUTIONS SECTION TO THE INSTRUCTIONS FOR USE FOR THE AVITENE FAMILY OF PRODUCTS.  THE ADDITIONAL LANGUAGE IS AS FOLLOWS:  "ANY EXCESS AVITENE MCH NOT REMOVED AT THE TIME OF SURGERY MAY EITHER PRESENT ITSELF AS A (RECURRING) MASS OR A (SPACE OCCUPYING) LESION OR IT MAY LEAD TO A FOREIGN BODY REACTION THAT MAY PRESENT WITH OR WITHOUT CLINICAL SIGNS AND SYMPTOMS AS A RECURRING MASS OR LESION OR POSTOPERATIVE ABSCESS FORMATION UPON IMAGING. IMAGING MAY INITIALLY NOT BE CAPABLE OF DISTINGUISHING THE DIFFERENCE. REMOVAL OF EXCESS MATERIAL, IDEALLY PERFORMED UPON CONCLUSION OF THE INITIAL PROCEDURE, TYPICALLY RESOLVES ALL SIGNS AND SYMPTOMS."
P800002|S018|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2011|01/23/2012|||APPR|APPROVAL FOR THE ADDITION OF A PRECAUTIONS SECTION TO THE INSTRUCTIONS FOR USE FOR THE AVITENE FAMILY OF PRODUCTS.  THE ADDITIONAL LANGUAGE IS AS FOLLOWS:  "ANY EXCESS AVITENE MCH NOT REMOVED AT THE TIME OF SURGERY MAY EITHER PRESENT ITSELF AS A (RECURRING) MASS OR A (SPACE OCCUPYING) LESION OR IT MAY LEAD TO A FOREIGN BODY REACTION THAT MAYPRESENT WITH OR WITHOUT CLINICAL SIGNS AND SYMPTOMS AS A RECURRING MASS OR LESION OR POSTOPERATIVE ABSCESS FORMATION UPON IMAGING. IMAGING MAY INITIALLY NOT BE CAPABLE OF DISTINGUISHING THE DIFFERENCE. REMOVAL OF EXCESS MATERIAL, IDEALLY PERFORMED UPON CONCLUSION OFTHE INITIAL PROCEDURE, TYPICALLY RESOLVES ALL SIGNS AND SYMPTOMS."
P050033|S014|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/23/2011|03/20/2012|||APPR|APPROVAL FOR ADDITION OF NEW SAFETY INFORMATION TO THE PRODUCT LABEL.
P080004|S010|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|BIOLOGICAL INDICATOR (BI)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2011|01/20/2012|||OK30|CHANGE TO THE INCUBATION TIME OF THE BIOLOGICAL INDICATOR.
P100023|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2011|04/05/2012|||APPR|APPROVAL FOR VARIOUS CYCLE TIME REDUCTIONS.
P110010|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2011|04/05/2012|||APPR|APPROVAL FOR VARIOUS CYCLE TIME REDUCTIONS.
P100023|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2011|01/20/2012|||OK30|ADDITION OF AN ALTERNATIVE COMBINATION MANDREL FOR WELDING DURING ASSEMBLY.
P000040|S021|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/23/2011|04/23/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S083|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2011|01/18/2012|||OK30|ADDITIONAL SUPPLIER OF BOVINE TISSUE.
P100041|S004|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2011|01/18/2012|||OK30|ADDITIONAL SUPPLIER OF BOVINE TISSUE.
P980041|S016|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2011|02/17/2012|||APPR|APPROVAL FOR THE CHANGE IN POLYPROPYLENE RESIN USED FOR MANUFACTURING OF THE REAGENT PACK CONTAINER.
P050045|S004|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion|TOP2A FISH PHARMADX KIT|NXG|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2011|06/01/2012|||APPR|APPROVAL FOR THE MANUFACTURING PROCESS OF PMA OLIGOMERS IN THE DEVICE.
P110010|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|||N|12/23/2011|05/10/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910023|S285|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|SJM ICDS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2011|05/10/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERATIONS MALAYSIA (SJM-MYPE) IN PENANG, MALAYSIA.
P030054|S212|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SJM CRTDS|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2011|05/10/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERATIONS MALAYSIA (SJM-MYPE) IN PENANG, MALAYSIA.
P850048|S026|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2011|02/17/2012|||APPR|APPROVAL FOR THE CHANGE IN POLYPROPYLENE RESIN USED FOR MANUFACTURING OF THE REAGENT PACK CONTAINER.
P970038|S015|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2011|02/17/2012|||APPR|APPROVAL FOR THE CHANGE IN POLYPROPYLENE RESIN USED FOR MANUFACTURING OF THE REAGENT PACK CONTAINER.
P100023|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2011|01/25/2012|||OK30|USE OF A NEW STATISTICAL ANALYSIS SOFTWARE PACKAGE IN THE MANUFACTURING PROCESS.
P980003|S034|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/27/2011|02/15/2012|||APPR|APPROVAL FOR FIVE CHANGES TO ADDRESS THE FAILURE OF A MICRO SWITCH DESIGNED TO AUTOMATICALLY SHUT OFF THE PUMP IF THE ROLLER BED COVER IS OPENED WITHOUT TURNING OFF THE POWER SWITCH.  THESE CHANGES INCLUDE:  1) INTRODUCING A NEW MICRO SWITCH WHICH FEATURES AN AUXILIARY ACTUATOR WHICH ELIMINATES DIRECT CONTACT BETWEEN THE RETAINER SCREW AND THE ACTUATOR BUTTON; 2) ADDING A SECONDARY SHOULDER ON THE RETAINER SCREW TO LIMIT THE SCREW PENETRATION DEPTH TO COINCIDE WITH THE TOLERANCE STACK UP WITH THE MICRO SWITCH POSITION; 3) MINOR DIMENSION AND TOLERANCE CHANGES TO THE MOUNTING PLATE TO ACCOMMODATE THE NEW MICRO SWITCH; 4) USE COUNTER-SINK HOLES INSTEAD OF STRAIGHT-THROUGH HOLES IN THE PUMP HEAD TO SECURE THE MOUNTING PLATE, ENSURING BRACKET ALIGNMENT AND MINIMIZING PLAY IN THE BRACKET INSTALLATION; AND 5) ADDING AN INSPECTION STEP AND TEST FIXTURE TO VERIFY THE INSTALLED POSITION OF THE MICRO SWITCH RELATIVE TO THE PUMP HEAD.
P860004|S167|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|12/27/2011|02/17/2012|||APPR|APPROVAL FOR THE SUTURELESS CONNECTOR (SC) CATHETER MODELS 8709SC AND 8731SC, AND REVISION KIT MODELS 8578 AND 8596SC TO ADDRESS THE POTENTIAL FOR SIDE LOAD LEAKS.  THE MODIFICATION TO YOUR SUTURELESS CONNECTOR ARE AS FOLLOWS:  1) DECREASED THE COUNTER BORE DIAMETER FROM 0.040" TO 0.035";  2) DECREASED THE DEPTH OF THE COUNTER BORE FROM 0.055" TO 0.050";  3) INCREASED THE TOLERANCE FOR THE 0.15" DIMENSION OF THE TUBING POSITION FROM +-0.01  TO  +-0.02;  AND 4) ADDED A REQUIREMENT TO THE PRODUCT SPECIFICATION FOR SIDE LOAD FORCES: CONNECTOR MUST NOT OCCLUDE OR LEAK WHEN PRESSURIZED TO 1.0 +- 0.1 PSIG AIR PRESSURE AND A FORCE OF 4.8 +- 0.1 LBF IS DISTRIBUTED OVER THE CONNECTOR SURFACE AT AN ANGLE OF 12 DEGREES +- 2 DEGREES.
P050034|S006|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X|NCJ|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/27/2011|02/23/2012|||APPR|APPROVAL FOR THE ADDITION OF THE INFORMATION REGARDING THE SAFETY OF THE DEVICE DURING MRI EXPOSURE TO THE PATIENT INFORMATION BOOKLET.
N16837|S009|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2011|05/11/2012|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER OF A MAJOR COMPONENT FOR THE MANUFACTURING OF THE DEVICE.
P080014|S010|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2011|01/20/2012|||OK30|CHANGE TO REPLACE QUALITY CONTROL TEST METHOD CONTROLS WITH NEW QUALITY CONTROL TEST METHOD CONTROLS FROM THE SAME SUPPLIER FOR INCOMING MATERIALS INSPECTION TESTING AND IN-PROCESS QUALITY CONTROL TESTING OF ACCESSORY KIT REAGENTS.
P010012|S277|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2011|01/25/2012|||OK30|MANUFACTURE OF THE BATTERY COMPONENT TO BE MANUFACTURED INTERNALLY AT ITS BOSTON SCIENTIFIC ST. PAUL MANUFACTURING FACILITY.
P960040|S249|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN/INCEPTA/ENERGEN/PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2011|01/25/2012|||OK30|MANUFACTURE OF THE BATTERY COMPONENT TO BE MANUFACTURED INTERNALLY AT ITS BOSTON SCIENTIFIC ST. PAUL MANUFACTURING FACILITY.
P010012|S278|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS/INCEPTA/ENERGEN/PUNCTUA/LIVIAN CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/2011|01/26/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR THE ANTENNA SOCK COMPONENT, AND FOR CHANGES TO THE RECEIVING ACCEPTANCE ACTIVITIES.
P960040|S250|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN/INCEPTA/ENERGEN/PUNCTUA/CONFIENT ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/2011|01/26/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR THE ANTENNA SOCK COMPONENT, AND FOR CHANGES TO THE RECEIVING ACCEPTANCE ACTIVITIES.
P960011|S020|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/2011|01/27/2012|||OK30|NEW VISCOMETER, FOR THE IN-PROCESS AND QUALITY CONTROL RELEASE TESTING.
P010029|S013|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/29/2011|01/27/2012|||OK30|NEW VISCOMETER, FOR THE IN-PROCESS AND QUALITY CONTROL RELEASE TESTING.
P000039|S043|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/29/2011|01/10/2012|||APPR|APPROVAL FOR LABELING CHANGES REGARDING DEVICE EROSION.
P970051|S089|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/30/2011|02/28/2012|||APPR|APPROVAL FOR THE CP800 SERIES SOFT EARHOOK, WHICH IS AN ACCESSORY TO THE CP810 SOUND PROCESSOR THAT ACTS AS AN ALTERNATIVE TO THE CURRENTLY MARKETED CP800 SERIES EARHOOK.
P960058|S095|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2011|06/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADVANCED BIONICS, LLC AND A FINISHED GOODS WAREHOUSE LOCATED IN VALENCIA, CALIFORNIA.
P040024|S056|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE L INJECTABLE GEL|LMH|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/10/2012|08/30/2012|12M-0968|09/12/2012|APPR|APPROVAL FOR RESTYLANE L INJECTABLE GEL.  THIS DEVICE IS INDICATED FOR: 1) MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS; AND 2) SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION IN PATIENTS OVER THE AGE OF 21.
P050012|S044|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN & SEVEN PLUS SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|01/03/2012|03/08/2012|||APPR|APPROVAL FOR A FIRMWARE MODIFICATION TO THE RECEIVED COMPONENT OF THE DEVICE IN ORDER TO INCREASE THE TONE AND DURATION OF USER ALERTS AND ALARMS.
P030054|S214|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE Q/PROMOTE QUADRA/UNIFY QUADRA/QUARTET CRT-DS|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/04/2012|03/02/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P810031|S042|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON5|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/04/2012|02/03/2012|||OK30|IMPLEMENTATION OF TEMPORARY USE OF AN AUTOCLAVE AT THE UPPSALA, SWEDEN FACILITY.
P010013|S043|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2012|05/03/2012|||APPR|APPROVAL FOR TWO ALTERNATIVE POWER SUPPLIES.
P990071|S016|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/04/2012|10/31/2012|||APPR|APPROVAL FOR UPGRADING THE EXISTING ACCESSORY COOLFLOW IRRIGATION PUMP FOR THE STOCKERT 70 RADIOFREQUENCY (RF) GENERATOR FOR CARDIAC ABLATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTABLATE IRRIGATION PUMP AND SMARTABLATE TUBING SET. THE INDICATIONS ARE THAT THE SMARTABLATE IRRIGATION PUMP IS A PERISTALTIC PUMP DESIGNED TO WORK IN CONJUNCTION WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR TO DELIVER IRRIGATION SOLUTION AT SPECIFIED NOW RATES TO IRRIGATED CATHETERS (SUCH AS THE BIOSENSE WEBSTER CELSIUS THERMOCOOL CATHETERS AND NAVISTAR THERMOCOOL CATHETERS) FOR COOLING PURPOSES. THE PUMP IS USED WITH THE SMARTABLATE IRRIGATION TUBING SET THAT CONDUCTS THE IRRIGATION SOLUTION FROM AN EXTERNAL SOURCE TO THE COMPATIBLE IRRIGATED CATHETERS.
P000058|S049|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2011|08/01/2013|||APPR|APPROVAL FOR A NEW NEUTRALIZING ANTIBODY ASSAY.
P000054|S034|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2011|08/01/2013|||APPR|APPROVAL FOR A NEW NEUTRALIZING ANTIBODY ASSAY.
P050053|S024|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2011|08/01/2013|||APPR|APPROVAL FOR A NEW NEUTRALIZING ANTIBODY ASSAY.
P030028|S003|OPHTEC BV|6421 CONGRESS AVE,SUITE 112||BOCA RATON|FL|33487||LENS, INTRAOCULAR, PHAKIC|ARTISAN-VERISYSE MYOPIA PHAKIC IOL|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|02/03/2012|||OK30|CHANGE IN THE POLY-METHYL METHACRYLATE (PMMA) MATERIAL.
P030023|S002|OPHTEC USA, INC.|6421 CONGRESS AVE., SUITE 112||BOCA RATON|FL|33487||Ring, endocapsular|OPHTEC-STABLEYES CAPSULAR TENSION RING|MRJ|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|03/12/2012|||APPR|APPROVAL FOR A NEW SUPPLIER OF A CRITICAL RAW MATERIAL.
P010014|S033|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/05/2012|02/03/2012|||APPR|APPROVAL FOR AN ADDITIONAL LABELING PIECE ENTITLED OXFORD PARTIAL KNEE X-RAY PROTOCOL.
P890047|S036|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|02/03/2012|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P840064|S048|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|02/03/2012|||OK30|CHANGE IN THE STERILIZATION PROCESS.
P890047|S037|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|02/01/2012|||OK30|NEW ANALYTICAL METHOD FOR RESIDUAL SOLVENTS.
P840064|S049|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|02/01/2012|||OK30|NEW ANALYTICAL METHOD FOR RESIDUAL SOLVENTS.
P950029|S065|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|02/02/2012|||OK30|ADDITIONAL OVEN, AN UPDATED CLEANING PROCESS, AND AN UPDATE TO THE REWORK PROCESS.
P980049|S069|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR & DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|02/02/2012|||OK30|ADDITIONAL OVEN, AN UPDATED CLEANING PROCESS, AND AN UPDATE TO THE REWORK PROCESS.
P060027|S036|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2012|02/02/2012|||OK30|ADDITIONAL OVEN, AN UPDATED CLEANING PROCESS, AND AN UPDATE TO THE REWORK PROCESS.
P970003|S144|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2012|02/01/2012|||OK30|THREE CHANGES TO THE MANUFACTURING PROCESS FOR THE PULSE GENERATOR IN THE DEVICE.
P950022|S081|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA FAMILY OF HIGH VOLTAGE LEADS|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|06/28/2012|||APPR|APPROVAL FOR IMPLEMENTATION OF A NEW AUTOMATED TESTER.
P040004|S008|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|02/03/2012|||OK30|ADDING AN IN-PROCESS STEP TO THE PREPARATION OF THE LABELED ANTIGEN.
P080015|S006|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18 COMPONENTS|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|01/09/2012|02/04/2013|||APPR|APPROVAL FOR SHELF-LIFE EXTENSION OF THE DEVICE FROM 12 MONTHS TO 18 MONTHS.
P070015|S086|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (ALSO DISTRIBUTED AS PROMUS EECSS)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|04/05/2012|||APPR|APPROVAL FOR A CHANGE IN SUBASSEMBLY PACKAGING.
P080014|S011|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR COMPONENTS|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|01/09/2012|02/04/2013|||APPR|APPROVAL FOR SHELF-LIFE EXTENSION OF THE DEVICE FROM 12 MONTHS TO 18 MONTHS.
P040008|S002|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA (TPSA)|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|02/08/2012|||OK30|ADD AN ALTERNATE SUPPLIER OF THE CRITICAL COMPONENT SOLID PHASE RECEPTACLE (SPR-PM) FOR THE VIDAS® TOTAL PSA AND FREE PSA PRODUCTS.
P080008|S001|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|VIDAS FREE PSA (FPSA) ASSAY|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|02/08/2012|||OK30|ADD AN ALTERNATE SUPPLIER OF THE CRITICAL COMPONENT SOLID PHASE RECEPTACLE (SPR-PM) FOR THE VIDAS® TOTAL PSA AND FREE PSA PRODUCTS.
P970004|S129|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|01/31/2012|||OK30|ALTERNATE SUPPLIER FOR A PROCESS FOR COATING CONDUCTOR WIRE.
P080025|S026|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|01/30/2012|||OK30|ALTERNATE SUPPLIER FOR A PROCESS FOR COATING CONDUCTOR WIRE.
P030047|S023|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE OTW/PRECISE RX & PRECISE PRO RX NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|02/06/2012|||OK30|USE OF NEW EQUIPMENT FOR THE UV BONDING PROCESS.
P020036|S022|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM FOR USE IN LLIAC ARTERIES|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2012|02/06/2012|||OK30|USE OF NEW EQUIPMENT FOR THE UV BONDING PROCESS.
P880086|S215|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT PACEMAKER DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2012|02/02/2012|||OK30|ALTERNATE SUPPLIER FOR RF ELECTRONIC ASSEMBLY MODULES.
P030035|S093|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2012|02/02/2012|||OK30|ALTERNATE SUPPLIER FOR RF ELECTRONIC ASSEMBLY MODULES.
P040037|S040|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS & ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2012|02/06/2012|||OK30|SOFTWARE MODIFICATIONS TO THE STENT WINDING MACHINE AND INCORPORATION OF A BARCODE SCANNER.
P010003|S016|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/10/2012|03/07/2012|||APPR|APPROVAL FOR A NEW ACCESSORY CALLED THE DELIVERY TIP EXTENSION (DTE).
P100023|S033|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/11/2012|08/20/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040045|S031|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2012|02/09/2012|||OK30|USE OF A DIFFERENT CLARIFYING FILTER FOR SENOFILCON A MONOMER MIXING DURING MANUFACTURING.
P070022|S025|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA CONTRACEPTION SYSTEM|KNH|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/2012|03/20/2012|||APPR|APPROVAL FOR MODIFICATIONS OF THE ADIANA RF GENERATOR TO INCORPORATE A TOUCH SCREEN USER INTERFACE.
P040037|S041|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS & ENDOPROSTHESIS WITH HERPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2012|02/06/2012|||OK30|TEMPERATURE CHANGE IN THE DEVICE LOADING PROCESS.
P050016|S009|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/2012|03/22/2013|||APPR|APPROVAL FOR THE REPROCESSING OF UNUSED CORMET RESURFACING HEADS THAT ARE APPROACHING THEIR EXPIRATION DATE.  THE UNUSED CORMET RESURFACING HEADS WILL BE OPENED FROM THE PACKAGING, CLEANED, REPACKED, RE-STERILIZED AND RELABELED WITH A 5 YEAR SHELF LIFE.
P780007|S047|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2012|02/10/2012|||OK30|ADDITIONAL DUPLICATE DRY LINES.
P780007|S048|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2012|02/09/2012|||OK30|ADDITION OF A NEW MICROBIAL AIR SAMPLER AND DESCRIPTION FOR BIOBURDEN MONITORING OF THE CLEAN ROOM.
P780007|S049|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2012|02/09/2012|||OK30|ADD DUPLICATE EQUIPMENT FOR LABORATORY USE.
P000040|S022|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2012|02/14/2012|||OK30|ADDITION OF A NEW SUPPLIER IN THE MANUFACTURING PROCESS.
P040048|S016|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2012|02/10/2012|||OK30|USE OF NEW LABELING SOFTWARE.
P060037|S016|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2012|02/10/2012|||OK30|USE OF NEW LABELING SOFTWARE.
P970003|S145|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2012|02/06/2012|||OK30|INTRODUCTION OF WORK INSTRUCTIONS TO ALLOW REWORK AND REPLACEMENT OF COMPONENTS IN THE VNS THERAPY SYSTEM.
P050043|S006|MORRIS INNOVATIVE RESEARCH INC|907 W.SECOND ST||BLOOMINGTON|IN|47403||Device, hemostasis, vascular|FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/13/2012|02/28/2012|||APPR|APPROVAL FOR A NEW VERSION OF THE SUB-INTESTINAL SUBMUCOSA (SIS) MATERIAL (VERSION 2.0).
P810031|S043|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON 5 PRODUCTS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2012|02/15/2012|||OK30|NEW SUPPLIER FOR HOLDERS AND RODS USED IN OPHTHALMIC VISCOELASTIC DEVICES.
P930038|S070|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2012|02/15/2012|||OK30|REMOVAL OF A COMPONENT CLEANING STEP.
P100010|S014|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2012|02/09/2012|||OK30|RAW MATERIAL CHANGE TO A COMPONENT OF THE DEVICE.
P040002|S036|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2012|02/15/2012|||OK30|CHANGE TO YOUR EPTFE GRAFT MANUFACTURING PROCESS.
P830055|S124|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/17/2012|03/16/2012|||APPR|APPROVAL FOR THE ADDITION OF LABELING CHANGES TO THE INSTRUCTIONS FOR USE (IFU) FOR VARIOUS CONFIGURATIONS OF THE DEVICE.
P070022|S026|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2012|02/09/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT HOLOGIC COSTA RICA SA. IN ALAJUELA, COSTA RICA.
P950009|S014|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT SLIDE PROFILER|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/17/2012|03/09/2012|||APPR|APPROVAL FOR UPDATING THE FIELD OF VIEW (FOV) BOARD FROM VERSION 2 TO VERSION 3.
P930014|S057|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2012|02/16/2012|||OK30|ADD A MOLDING SYSTEM.
P000053|S040|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2012|03/09/2012|||APPR|APPROVAL FOR MINOR CHANGES TO SEVERAL DIMENSIONAL TOLERANCES OF THE BALLOON ADAPTOR SUBCOMPONENT.
P040020|S039|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2012|02/16/2012|||OK30|ADD A MOLDING SYSTEM.
P090002|S002|DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/19/2012|04/17/2012|||APPR|APPROVAL FOR THE ADDITION OF THE TRILOCK BPS (BONE PRESERVING HIP STEM) TO THE LIST OF COMPATIBLE FEMORAL STEM COMPONENTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM AND IS INDICATED AS A SINGLE USE DEVICE INTENDED FOR UNCEMENTED FIXATION.  THE DEVICE IS INTENDED AS A PRIMARY JOINT REPLACEMENT PROSTHESIS IN TOTAL HIP ARTHROPLASTY FOR SKELETALLY MATURE PATIENTS SUFFERING AT LEAST MODERATE PAIN IN THE HIP JOINT FROM NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) AND ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS (OA) OR POST-TRAUMATIC ARTHRITIS.  THE DEVICE¿S INSERTS (PINNACLE ULTAMET) ARE ONLY INTENDED FOR USE WITH DEPUY¿S FEMORAL AND ACETABULAR COMPONENTS HAVING MATCHING OUTER AND INNER DIAMETERS.
P060008|S084|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|01/20/2012|02/15/2012|||OK30|MODIFICATION OF WATER SYSTEM MONITORING.
P100023|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|01/20/2012|02/15/2012|||OK30|MODIFICATION OF WATER SYSTEM MONITORING.
P100041|S005|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2012|02/17/2012|||OK30|USE OF A NEW CLEANROOM AND CHANGES TO CRIMPER MOLDS.
P030017|S126|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2012|02/17/2012|||OK30|CHANGES TO THE NICKEL STRIP WELDING PROCESS AT THE BATTERY TERMINALS FOR THE DEVICE.
P030017|S127|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2012|02/17/2012|||OK30|CHANGES TO THE NICKEL STRIP WELDING PROCESS TO THE KOVAR TABS FOR THE DEVICE.
P100029|S010|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2012|02/06/2012|||OK30|CHANGES TO INCLUDE: 1) AN ALTERNATE ELECTROPOLISHING METHOD; 2) SEMI-AUTOMATION OF STENT ROTATION; AND 3) CHANGE IN FIXTURE MATERIAL.
P830055|S125|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2012|02/21/2012|||APPR|APPROVAL FOR ADDITIONAL INSPECTION STEPS TO THE MANUFACTURING PROCESS OF THE SIGMA PS FEMORAL COMPONENTS, SIGMA PS FEMORAL COMPONENTS WITH LUGS AND SIGMA RPF FEMORAL COMPONENTS.
P030031|S038|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERMACOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS|OAD|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/23/2012|03/23/2012|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE FOR THE CATHETERS REFERENCED FROM ONE TO THREE YEARS.
P010047|S015|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/19/2012|03/19/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P070015|S087|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|01/24/2012|09/14/2012|||APPR|APPROVAL TO UPDATE THE PRODUCT LABELING CONTAINED IN THE INSTRUCTIONS FOR USE (IFU) AND PATIENT GUIDE FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE UPDATES SPECIFICALLY INCLUDED LONGER TERM FOLLOW-UP DATA TO ALLAPPLICABLE CLINICAL TRIALS FOR THE DEVICES.
P110019|S009|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|01/24/2012|09/14/2012|||APPR|APPROVAL TO UPDATE THE PRODUCT LABELING CONTAINED IN THE INSTRUCTIONS FOR USE (IFU) AND PATIENT GUIDE FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE UPDATES SPECIFICALLY INCLUDED LONGER TERM FOLLOW-UP DATA TO ALLAPPLICABLE CLINICAL TRIALS FOR THE DEVICES.
P980022|S108|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2012|03/30/2012|||APPR|APPROVAL FOR AN ALTERNATIVE SUPER CAPACITOR USED ON THE INTERFACEBOARD OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, -522K, -722, -722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, -523K, -723, -723K) WHICH ARE COMPONENTS OF THE CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM.
P080011|S007|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2012|02/23/2012|||OK30|CHANGE IN THE FREQUENCY OF SANITIZATION OF THE INSPECTION TRAYS USED IN THE AUTOMATED WET LINE INSPECTION PROCESS.
P080011|S008|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2012|02/23/2012|||OK30|CHANGE IN THE STORAGE CONDITIONS AWAITING AUTOMATED WET LINE INSPECTION.
P860003|S064|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS|LNR|GU|Special (Immediate Track)||N|01/24/2012|04/04/2012|||APPR|APPROVAL FOR LABELING CHANGES TO ENSURE THE APPROPRIATE DOSING OF HEPARIN FOR LOW BODY WEIGHT PATIENTS.
P050047|S021|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2012|02/23/2012|||OK30|REVIEW OF THE ANNUAL REVALIDATION OF THE JUVÈDERM STERILIZATION CYCLE, AND THE QUALIFICATION OF A NEW STERILIZER.
P960004|S050|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS|NVN|CV|30-Day Notice||N|01/24/2012|02/29/2012|||OK30|CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
P010012|S279|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2 LV-1 & IS-1, EASYTRAK 3 LV-1 & IS-1, AND ACUITY SPIRAL LEADS|LWP|CV|30-Day Notice||N|01/24/2012|02/29/2012|||OK30|CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
P050046|S013|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE IS-1 LEADS|NVY|CV|30-Day Notice||N|01/24/2012|02/29/2012|||OK30|CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
P910073|S100|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS|LWS|CV|30-Day Notice||N|01/24/2012|02/29/2012|||OK30|CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
P910077|S118|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD|LWS|CV|30-Day Notice||N|01/24/2012|02/29/2012|||OK30|CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
P960006|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND LEADS|NVY|CV|30-Day Notice||N|01/24/2012|02/29/2012|||OK30|CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
P050047|S022|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/25/2012|02/24/2012|||APPR|APPROVAL FOR THE ADDITION OF A NEW PRECAUTION STATEMENT:  FAILURE TO COMPLY WITH THESE INSTRUCTIONS COULD RESULT IN NEEDLE DISENGAGEMENT AND/OR PRODUCT LEAKAGE AT TE LUER-LOCK NEEDLE HUB CONNECTION.
P020056|S016|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/25/2012|10/01/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S085|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS, 3000/3000TFX AND 3300TFX|DYE|CV|30-Day Notice||N|01/25/2012|02/24/2012|||OK30|AUTOMATED, GREATER CAPACITY MIXING, STORAGE AND DISTRIBUTION DELIVERY SYSTEM.
P030004|S005|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM|MFE|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/26/2012|04/05/2012|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE AND PATIENT BROCHURE THAT STRENGTHEN THE WARNINGS ABOUT CATHETER ENTRAPMENT.
P010012|S280|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK RENEWAL TR, CONTAK RENEWAL 3, LEVIAN SE/HE, COGNIS, INCEPTA|NIK|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2012|02/16/2012|||APPR|APPROVAL FOR A SHELF LIFE EXTENSION FROM 4 YEARS TO 5 YEARS FOR THE SUBJECT LV-1 LEAD PORT PLUG.
P040025|S012|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP SYSTEM|MXM|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/26/2012|03/27/2012|||APPR|APPROVAL FOR A REDESIGNED PRINTED CIRCUIT BOARD (THE SYSCAM PCB, PREVIOUSLY PN 401339 AND NOW PN 002819), FOR THE DEVICE.
P080011|S009|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2012|02/24/2012|||APPR|APPROVAL FOR AN ADDITIONAL DENSITY CHECK OF THE LENS EXTRACTION/HYDRATION TANKS.
P100041|S006|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/26/2012|03/20/2012|||APPR|APPROVAL FOR USE OF A PREVIOUSLY APPROVED ALTERNATE MATERIAL FOR THE FLUSH TUBE.
P980049|S070|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR & DR|MRM|CV|30-Day Notice||N|01/27/2012|02/16/2012|||OK30|CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT.
P060027|S037|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D|NIK|CV|30-Day Notice||N|01/27/2012|02/16/2012|||OK30|CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT.
P950029|S066|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT|NVZ|CV|30-Day Notice||N|01/27/2012|02/16/2012|||OK30|CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT.
P020030|S009|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|STELID II BFT/BJF/STELIX BR/STELIX II BRF|NVY|CV|30-Day Notice||N|01/27/2012|02/16/2012|||OK30|CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT.
P910001|S053|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2012|02/24/2012|||OK30|REMOVE REDUNDANT QUALITY CONTROL INSPECTION STEPS IN YOUR FIBER DRAW AND FIBER RE-SPOOLING MANUFACTURING PROCESSES.
P960042|S034|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2012|02/24/2012|||OK30|REMOVE REDUNDANT QUALITY CONTROL INSPECTION STEPS IN YOUR FIBER DRAW AND FIBER RE-SPOOLING MANUFACTURING PROCESSES.
P020016|S006|BIOMET MICROFIXATION, INC.|1520 TRADEPORT DR.||JACKSONVILLE|FL|32218||Joint, temporomandibular, implant|TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM|LZD|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2012|03/15/2012|||OK30|CHANGE IN THE CLEANING DETERGENT, A CHANGE IN THE MACHINING OIL AND A MANUFACTURING PROGRAM CHANGE.
P950037|S101|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA / ENTOVIS FAMILY PULSE GENERATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2012|03/23/2012|||APPR|APPROVAL FOR MINOR HARDWARE MODIFICATIONS TO THE EVIA/ENTOVIS FAMILY OF PULSE GENERATORS WHICH INCLUDES THE ESTELLA/EFFECTA/ECURO PULSE GENERATORS.
P980040|S038|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1-PEICE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00, SENSAR 1-PIECE LENS MODEL AAB00|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2012|02/29/2012|||OK30|IMPLEMENT A SOFTWARE AND HARDWARE UPGRADE TO THE EQUIPMENT USED TO MEASURE OPTICAL PROPERTIES OF INTRA- OCULAR LENSES.
P080010|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL LENS MODEL ZMA00|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2012|02/29/2012|||OK30|IMPLEMENT A SOFTWARE AND HARDWARE UPGRADE TO THE EQUIPMENT USED TO MEASURE OPTICAL PROPERTIES OF INTRA- OCULAR LENSES.
P050023|S049|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIO MESSENGER & CARDIO MESSENGER II-S FAMILIES|MRM|CV|Real-Time Process||N|01/30/2012|03/29/2012|||APPR|APPROVAL FOR AN UPDATE TO LEAD-FREE SOLDER FOR PRINTED CIRCUIT BOARD MANUFACTURING.
P950037|S102|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CARDIO MESSENGER II & CARDIO MESSENGER II-S FAMILIES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/30/2012|03/29/2012|||APPR|APPROVAL FOR AN UPDATE TO LEAD-FREE SOLDER FOR PRINTED CIRCUIT BOARD MANUFACTURING.
P950018|S015|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2012|03/30/2012|||APPR|APPROVAL FOR MINOR LABELING CHANGES TO THE APPROVED SECONDARY LABEL LID AND TO IMPLEMENT AN ALTERNATE SECONDARY PRINTING OPERATION ASSOCIATED WITH THE IMPLEMENTATION OF THESE MINOR LABELING CHANGES.
P100021|S013|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2012|02/29/2012|||OK30|CHANGE TO MANDREL MATERIAL.
P010047|S016|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL LEAK SEALANT|NBE|AN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2012|03/23/2012|||APPR|APPROVAL FOR AN EXTENSION OF SHELF LIFE OF THE PROGEL EXTENDED APPLICATOR SPRAY TIPS FORM 12 TO 24 MONTHS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROGEL EXTENDED APPLICATOR SPRAY TIPS AND IS INDICATED TO DELIVER PROGEL TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE (I.E. WITH SUTURES OR STAPLES) OF VISIBLE AIR LEAKS (>= 2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA IN ADULT HUMANS BY BENDING THE MALLEABLE TIP TO DIRECT PROGEL FROM THE DELIVERY TIP IN A STREAM OR SPRAY CONE PATTERN THAT IS PERPENDICULAR TO THETARGET SURFACE.
P000044|S029|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2012|02/23/2012|||OK30|CHANGING THE TIMING OF THE TESTS IN THE QA RELEASE TEST FROM SEQUENTIAL TO CONCURRENT, DESCRIBED AS THE SINGLE TEST.
P030024|S018|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2012|02/23/2012|||OK30|CHANGING THE TIMING OF THE TESTS IN THE QA RELEASE TEST FROM SEQUENTIAL TO CONCURRENT, DESCRIBED AS THE SINGLE TEST.
P010021|S022|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2012|02/23/2012|||OK30|CHANGING THE TIMING OF THE TESTS IN THE QA RELEASE TEST FROM SEQUENTIAL TO CONCURRENT, DESCRIBED AS THE SINGLE TEST.
P030026|S025|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2012|02/23/2012|||OK30|CHANGING THE TIMING OF THE TESTS IN THE QA RELEASE TEST FROM SEQUENTIAL TO CONCURRENT, DESCRIBED AS THE SINGLE TEST.
P960013|S070|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|OPTISENSE LEAD MODEL 1999 TUBING|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|02/23/2012|||OK30|ELIMINATE A PRIMING PROCESS.
P030017|S128|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice||N|01/31/2012|02/29/2012|||OK30|ADDITION OF CLARIFICATIONS TO THE EXISTING VISUAL INSPECTION CRITERIA FOR THE FEEDTHROUGH COMPONENT OF THE IMPLANTABLE PULSE GENERATOR (IPG).
P990056|S016|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/18/2012|||APPR|APPROVAL TO TRANSFER A PORTION OF THE MANUFACTURING OPERATIONS, SPECIFICALLY COMPOUNDING OF BULK REAGENTS, TO NEWLY CONSTRUCTED BUILDINGS 662 AND 663 WITHIN THE ROCHE PENZBERG, GERMANY FACILITY.
P000027|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/18/2012|||APPR|APPROVAL TO TRANSFER A PORTION OF THE MANUFACTURING OPERATIONS, SPECIFICALLY COMPOUNDING OF BULK REAGENTS, TO NEWLY CONSTRUCTED BUILDINGS 662 AND 663 WITHIN THE ROCHE PENZBERG, GERMANY FACILITY.
P110019|S010|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|02/21/2012|||OK30|MODIFICATION OF A MARKER ALIGNMENT TEMPLATE; AND A CHANGE TO THE IN-PROCESS ACCEPTANCE CRITERIA FOR ONE BALLOON LENGTH SIZE.
P830055|S126|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/31/2012|03/30/2012|||APPR|APPROVAL TO ADD THE DEPUY UNIVERSAL STEM EXTENSIONS AS COMPATIBLE COMPONENTS TO THE PREVIOUSLY APPROVED LCS COMPLETE MODULAR FEMORAL COMPONENTS, LCS COMPLETE REVISION FEMORAL COMPONENTS, AND MBT TIBIAL TRAYS, AND TO ADD THE DEPUY UNIVERSAL FEMORAL METAPHYSEAL SLEEVES AS COMPATIBLE COMPONENTS TO THE LCS COMPLETE REVISION FEMORAL COMPONENTS.
P000040|S023|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|02/29/2012|||OK30|NEW SUPPLIER OF SEVERAL COMPONENTS OF THE CONTROL UNIT SUBASSEMBLIES.
P110022|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON COBAS E 601|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|06/18/2012|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH, IN MANNHEIM, GERMANY.
P110025|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|06/18/2012|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH, IN MANNHEIM, GERMANY.
P110031|S001|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON COBAS E 411|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|06/18/2012|||APPR|APPROVAL FOR MANUFACTURING SITE LOCATED AT ROCHE DIAGNOSTICS GMBH, IN MANNHEIM, GERMANY.
P990012|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P010054|S018|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P100031|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P100032|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC ON ELECSYS 2010|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P090007|S007|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV ON COBAS E 411|MZO|MI|135 Review Track For 30-Day Notice||N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P090008|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV ON COBAS E 601|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P090009|S007|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P110022|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ON COBAS E 601|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P110025|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170|LOM|MI|135 Review Track For 30-Day Notice||N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P110031|S002|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ON COBAS E 411|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2012|12/20/2012|||APPR|APPROVAL FOR A  TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
P030005|S081|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR|NKE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/30/2012|02/16/2012|||APPR|APPROVAL FOR A SHELF LIFE EXTENSION FROM 4 YEARS TO 5 YEARS FOR THE SUBJECT LV-1 LEAD PORT PLUG.
P940035|S008|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT|NAH|IM|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/22/2010|03/21/2012|||APPR|APPROVAL FOR THE INTENT TO MANUFACTURE THE  NMP22 BLADDERCHEK TEST AND NMP22 BLADDERCHEK CONTROL KIT UNDER ALERE SCARBOROUGH, INC. BRAND NAME.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAME: ALERE NMP22 BLADDERCHEK TEST, WITH THE FOLLOWING INTENDED USE: THE ALERE NMP22 BLADDERCHEK TEST IS AN IN VITRO IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF THE NUCLEAR MITOTIC APPARATUS PROTEIN  (NUMA), WHICH IS AN ABUNDANT COMPONENT OF THE NUCLEAR MATRIX PROTEINS, IN URINE OF PERSONS WITH RISK FACTORS OR SYMPTOMS OF BLADDER CANCER OR WITH A HISTORY OF BLADDER CANCER.  THIS TEST IS INDICATED FOR PROFESSIONAL USE AND PRESCRIPTION HOME USE AS AN AID IN DIAGNOSING AND MONITORING BLADDER CANCER PATIENTS, IN CONJUNCTION WITH STANDARD DIAGNOSTIC PROCEDURES.ALERE NMP22 BLADDERCHEK CONTROL KIT, WITH THE FOLLOWING INTENDED USE: ALERE NMP22 BLADDERCHEK CONTROL KIT IS DESIGNED TO PROVIDE THE USERS OF THE ALERE NMP22 BLADDERCHEK TEST WITH ADDITIONAL, OPTIONAL, QUALITY CONTROLS FOR OPERATING THE TEST.
P010032|S047|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CHARGING ANTENNA AND PORTABLE CHARGER ANTENNA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|03/02/2012|||OK30|MODIFICATION TO THE ACCEPTANCE CRITERIA FOR THE CHARGING ANTENNA AND PORTABLE CHARGING ANTENNA.
P080011|S010|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|02/29/2012|||OK30|INSTALLATION OF A DUPLICATE AUTOCLAVE.
P020027|S017|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2012|03/22/2012|||APPR|APPROVAL FOR A SOFTWARE REVISION THAT CHANGES THE OPERATING SYSTEM OF THE INSTRUMENT FROM THE CURRENT QNX OPERATING SYSTEM TO THE LINUX OPERATING SYSTEM AND ADDRESSES HARDWARE OBSOLESCENCE ISSUES.
P850035|S034|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|02/27/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF COIN CELL BATTERIES.
P060002|S024|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|09/27/2012|||APPR|APPROVAL FOR AUTOMATION OF AN INSPECTION STEP.
P080007|S011|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|E-LUMINEXX VASCULAR STENT|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|09/27/2012|||APPR|APPROVAL FOR AUTOMATION OF AN INSPECTION STEP.
P070014|S030|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|09/27/2012|||APPR|APPROVAL FOR AUTOMATION OF AN INSPECTION STEP.
P010047|S017|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|03/01/2012|||OK30|IMPLEMENT AN AUTOMATED UV BONDING SYSTEM TO BUILD EXTENDED TIPS.
P860003|S065|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2012|03/02/2012|||APPR|APPROVAL FOR A TECHNICAL BULLETIN (TECHNICAL BULLETIN XTS #1) THAT WILL BE SENT OUT TO USERS OF THE UVAR XTS PHOTOPHERESIS SYSTEM.
P810002|S079|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice||N|02/01/2012|02/29/2012|||OK30|CHANGE IN X-RAY DIFFRACTION EQUIPMENT.
P010019|S029|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|03/02/2012|||OK30|RAW MATERIAL TEST METHOD CHANGES.
P970020|S070|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|05/25/2012|||APPR|APPROVAL OF A STERILIZATION SITE LOCATED AT SYNERGY HEALTH IRELAND, LTD., IN OFFALY, IRELAND.
P020047|S041|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION CORONARY STENT SYSTEMS|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|05/25/2012|||APPR|APPROVAL OF A STERILIZATION SITE LOCATED AT SYNERGY HEALTH IRELAND, LTD., IN OFFALY, IRELAND.
P050023|S050|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX ICDS AND CRT-DS|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2012|03/29/2012|||APPR|APPROVAL FOR AN ADAPTER FOR THE HIGH VOLTAGE CAPACITOR AND FEEDTHROUGH.
P000008|S027|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BAND|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/29/2012|08/29/2013|||APPR|APPROVAL FOR CHANGES TO THE PACKAGING, SEALING PARAMETERS AND STERILIZATION LOAD SIZE FOR THE DEVICE.
P950032|S067|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2012|02/22/2012|||APPR|APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELL STRAIN (HEP 158) INTO THE MANUFACTURE OF THE DEVICE.
P010027|S004|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|03/02/2012|||OK30|ALTERNATE VENDOR TO PERFORM LIMULUS AMEBOCYTE LYSATE (LAL) TESTING.
P070015|S088|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|09/10/2012|||APPR|APPROVAL FOR TRANSFERRING THE TESTING OF TOTAL ORGANIC CARBON (TOC) FROM A CONTRACT LABORATORY TO ABBOTT VASCULAR IN TEMECULA, CA.
P110019|S011|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|09/10/2012|||APPR|APPROVAL FOR TRANSFERRING THE TESTING OF TOTAL ORGANIC CARBON (TOC) FROM A CONTRACT LABORATORY TO ABBOTT VASCULAR IN TEMECULA, CA.
P030022|S021|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM (RCHS)|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2012|06/28/2012|||APPR|APPROVAL FOR ADDITION OF AN ALTERNATE SITE FOR THE MACHINING PROCESSES FOR R3 ACETABULAR SHELLS.
P010027|S005|AAREN SCIENTIFIC|4290 EAST BRICKELL ST, BLDG A||ONTARIO|CA|91761||intraocular lens|ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|03/02/2012|||OK30|INSTALLATION OF AN OPTICAL TESTING LABORATORY OPTICAL BENCH.
P110022|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON COBAS E 601|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|MANUFACTURING PROCESS CHANGE TO INCREASE THE CONCENTRATION OF THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P110025|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|MANUFACTURING PROCESS CHANGE TO INCREASE THE CONCENTRATION OF THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P110031|S003|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON COBAS E 411|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|MANUFACTURING PROCESS CHANGE TO INCREASE THE CONCENTRATION OF THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P110022|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON COBAS E 601|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|CHANGE TO THE IN- PROCESS PARTICLE CONCENTRATION DETERMINATION METHOD FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P110025|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|CHANGE TO THE IN- PROCESS PARTICLE CONCENTRATION DETERMINATION METHOD FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P110031|S004|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON COBAS E 411|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|CHANGE TO THE IN- PROCESS PARTICLE CONCENTRATION DETERMINATION METHOD FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P110022|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON COBAS E 601|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|CHANGE TO INCREASE PRODUCTION CAPACITY FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P110025|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|CHANGE TO INCREASE PRODUCTION CAPACITY FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P110031|S005|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM ON COBAS E 411|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2012|02/27/2012|||OK30|CHANGE TO INCREASE PRODUCTION CAPACITY FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
P980035|S257|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR, VERSA, ENRHYTHM, RELIA, & VARIOUS FAMILIES OF ADAPTA & SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2012|02/29/2012|||OK30|REDUCTION IN LINE TESTING SAMPLE SIZE FOR A COMPONENT.
P990001|S100|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR/C60 DR/T20 SR/T60 DR IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2012|02/29/2012|||OK30|REDUCTION IN LINE TESTING SAMPLE SIZE FOR A COMPONENT.
P980016|S334|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2012|02/29/2012|||OK30|REDUCTION IN LINE TESTING SAMPLE SIZE FOR A COMPONENT.
P010015|S152|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA & SYNCRA CRT-PS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2012|02/29/2012|||OK30|REDUCTION IN LINE TESTING SAMPLE SIZE FOR A COMPONENT.
P010031|S287|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC III MARQUIS & INSYNC MAXIMO ICDS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2012|02/29/2012|||OK30|REDUCTION IN LINE TESTING SAMPLE SIZE FOR A COMPONENT.
P090013|S050|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2012|02/29/2012|||OK30|REDUCTION IN LINE TESTING SAMPLE SIZE FOR A COMPONENT.
P010012|S281|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, CONTAK RENEWAL 3/3 HE, LIVIAN CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2012|03/01/2012|||OK30|ADDITION OF A NEW MANUFACTURING EQUIPMENT.
P960040|S251|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, VENTAK PRIZM HE, CONFIENT, & VARIOUS FAMILIES OF VITALITY ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2012|03/01/2012|||OK30|ADDITION OF A NEW MANUFACTURING EQUIPMENT.
P070015|S089|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS CORONARY STENT SYSTEM & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|02/03/2012|03/02/2012|||OK30|EQUIPMENT UPGRADE FOR USE IN THE STENT RETENTION PROCESS.
P110019|S012|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|02/03/2012|03/02/2012|||OK30|EQUIPMENT UPGRADE FOR USE IN THE STENT RETENTION PROCESS.
P020009|S081|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|02/03/2012|03/02/2012|||OK30|CHANGE TO THE BALLOON DRYING PROCESS.
P040016|S084|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|02/03/2012|03/02/2012|||OK30|CHANGE TO THE BALLOON DRYING PROCESS.
P060006|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice||N|02/03/2012|03/02/2012|||OK30|CHANGE TO THE BALLOON DRYING PROCESS.
P060008|S085|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY SYSTEM|NIQ|CV|30-Day Notice||N|02/03/2012|03/02/2012|||OK30|CHANGE TO THE BALLOON DRYING PROCESS.
P100023|S035|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|02/03/2012|03/02/2012|||OK30|CHANGE TO THE BALLOON DRYING PROCESS.
P020047|S042|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/03/2012|04/03/2012|||APPR|APPROVAL FOR CHANGES TO THE MULTI-LINK 8 CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) TO ALIGN/UPDATE THE IFU VERBIAGE WITH A RECENTLY APPROVED CORONARY STENT SYSTEM.
P970058|S025|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGECHECKER CAD|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/2012|09/21/2012|||APPR|APPROVAL FOR IMPROVEMENTS IN THE CAD ALGORITHM, UPDATED DIGITAL TEST DATABASE AND SUPPORT FOR GE SENOGRAPHE ESSENTIAL FFDM.
P110019|S013|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2012|03/07/2012|||OK30|REMOVAL OF AN INSPECTION STEP.
P060011|S003|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7||intraocular lens|RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2012|03/08/2012|||OK30|SOFTWARE UPGRADE TO THE OPTICAL MEASURING EQUIPMENT.
P050049|S010|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM HBSAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2012|03/01/2012|||OK30|CHANGE TO THE TWO MICROBIAL TESTING METHODS FOR BIOBURDEN AND STERILITY DETERMINATION FOR CODE 37199 AND 97218.
P070015|S090|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|02/06/2012|03/07/2012|||OK30|CHANGE TO THE BALLOON MANUFACTURING PROCESS.
P970020|S071|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|RX ZETA, OTW ZETA|MAF|CV|30-Day Notice||N|02/06/2012|03/07/2012|||OK30|CHANGE TO THE BALLOON MANUFACTURING PROCESS.
P020047|S043|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION RX, VISION OTW MINI VISION RX, MINI VISION OTW|MAF|CV|30-Day Notice||N|02/06/2012|03/07/2012|||OK30|CHANGE TO THE BALLOON MANUFACTURING PROCESS.
P050023|S051|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX ICDS AND CRT-DS|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2012|03/05/2012|||OK30|NEW LASER WELD PROCESS TO WELD CONNECTION BANDS TO NICKEL PADS.
P950037|S103|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2012|03/05/2012|||OK30|NEW LASER WELD PROCESS TO WELD CONNECTION BANDS TO NICKEL PADS.
P070008|S029|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2012|03/05/2012|||OK30|NEW LASER WELD PROCESS TO WELD CONNECTION BANDS TO NICKEL PADS.
P030036|S040|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|MEDTRONIC SELECTSECURE LEAD MODEL 3830|NVN|CV|Normal 180 Day Track No User Fee||N|02/06/2012|11/02/2012|||APPR|APPROVAL FOR IMPROVEMENTS TO THE SELECTSECURE MODEL 3830 LEAD DRUG METHODS AND SPECIFICATIONS.
P930014|S058|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF TORIC HIGH CYLINDER POWER IOL|HQL|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/06/2012|06/07/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P900060|S048|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2012|03/07/2012|||OK30|MODIFICATION TO THE LABELING ALGORITHM.
P980035|S258|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR, VERSA, ENRHYTHM, RELIA, & VARIOUS FAMILIES OF ADAPTA & SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2012|03/07/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING MANUFACTURING EQUIPMENT.
P090013|S051|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2012|03/07/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING MANUFACTURING EQUIPMENT.
P010031|S288|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC III MARQUIS & INSYNC MAXIMO ICDS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2012|03/07/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING MANUFACTURING EQUIPMENT.
P980016|S335|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2012|03/07/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING MANUFACTURING EQUIPMENT.
P020004|S070|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2012|03/16/2012|||APPR|APPROVAL FOR AN ALTERNATE FLUORINATED ETHYLENE PROPYLENE (FEP) RESIN AND AN ALTERNATE SUPPLIER FOR THE FEP FILM.  THE SUPPLEMENT ALSO REQUESTED APPROVAL FOR A CHANGE TO THE SPECIFICATIONS OF THE FEP FILM.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME IDENTIFIED.
P040043|S045|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2012|03/16/2012|||APPR|APPROVAL FOR AN ALTERNATE FLUORINATED ETHYLENE PROPYLENE (FEP) RESIN AND AN ALTERNATE SUPPLIER FOR THE FEP FILM.  THE SUPPLEMENT ALSO REQUESTED APPROVAL FOR A CHANGE TO THE SPECIFICATIONS OF THE FEP FILM.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME IDENTIFIED.
P810002|S080|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM MASTERS HP VALVED GRAFT|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2012|02/19/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL ARECIBO, IN ARECIBO, PUERTO RICO.
P070007|S034|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT CAPTIVIA STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/07/2012|03/05/2012|||APPR|APPROVAL FOR LABELING CHANGES AND A CHANGE IN THE GRAFT LOADING PROCESS.
P980022|S109|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2012|03/09/2012|||OK30|IMPLEMENTATION OF A NEW CLEANING SYSTEM CALLED ISOPROPYL ALCOHOL RECIRCULATING CLEANING OR IPARC. THE IPARC SYSTEM IS USED TO CLEAN THE SENSOR BASE AND NEEDLE ASSEMBLY COMPONENTS OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002, MMT-7003). THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME SYSTEM, CGMS IPRO SYSTEM AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM.
P040044|S043|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2012|04/05/2012|||APPR|APPROVAL FOR ADDING A 5F VERSION TO THE MYNXGRIP¿ PRODUCT LINE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH.
P000025|S061|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice||N|02/08/2012|03/28/2012|||OK30|USE OF NEW SILICONE MIXING EQUIPMENT.
P040002|S037|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/13/2012|06/01/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE SUREPASS CONTRALATERAL LIMB WIRE SUBASSEMBLY.
P020047|S044|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|01/31/2012|02/21/2012|||OK30|MODIFICATION OF A MARKER ALIGNMENT TEMPLATE; AND A CHANGE TO THE IN-PROCESS ACCEPTANCE CRITERIA FOR ONE BALLOON LENGTH SIZE.
P010031|S289|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2012|03/05/2012|||OK30|ALIGN THE PRODUCTION PROCESSES FOR THE DEVICES WITH THOSE USED FOR APPROVED PREDECESSOR PRODUCTS.
P980016|S336|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2012|03/05/2012|||OK30|ALIGN THE PRODUCTION PROCESSES FOR THE DEVICES WITH THOSE USED FOR APPROVED PREDECESSOR PRODUCTS.
P010031|S290|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2012|02/29/2012|||OK30|APPROVAL FOR FOUR MANUFACTURING CHANGES:  1) RF MODULE SOLDER FLUX CLEAN ADDITION; 2) FLUX INSPECTION CHANGE; 3) RADIO FREQUENCY DEVICE TEST UPDATE; AND 4) A MANUFACTURING SITE MOVE FOR 8-PIN FILTERS.
P980016|S337|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2012|02/29/2012|||OK30|APPROVAL FOR FOUR MANUFACTURING CHANGES:  1) RF MODULE SOLDER FLUX CLEAN ADDITION; 2) FLUX INSPECTION CHANGE; 3) RADIO FREQUENCY DEVICE TEST UPDATE; AND 4) A MANUFACTURING SITE MOVE FOR 8-PIN FILTERS.
P010012|S282|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PUNCTUA CRT-D MODELS (N050, N051), ENERGEN CRT-D MODELS (N140, N141) INCEPTA CRT-D MODELS (N160, N161, N164)|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2012|03/15/2012|||APPR|APPROVAL FOR MINOR DESIGN CHANGES AND ASSOCIATED MANUFACTURING CHANGES TO THE PUNCTUA/ INCEPTA/ ENERGEN HYBRID ASSEMBLY.
P960040|S252|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA ICD MODELS (E050, E051, E052, E052), ENERGEN ICD MODELS (E140, E141, E142, E143) INCEPTA ICD MODELS (E160, E161,|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2012|03/15/2012|||APPR|APPROVAL FOR MINOR DESIGN CHANGES AND ASSOCIATED MANUFACTURING CHANGES TO THE PUNCTUA/ INCEPTA/ ENERGEN HYBRID ASSEMBLY.
P910023|S287|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/09/2012|04/06/2012|||APPR|APPROVAL FOR THE MERLIN.NET SOFTWARE VERSION 6.0A.
P980022|S110|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/2012|07/17/2012|||APPR|APPROVAL FOR LANGUAGE AND PICTORIAL CHANGES TO THE INSTRUCTIONS FORUSE (IFU) OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002) TO MAKE IT CONSISTENT WITH THE LANGUAGE THAT IS INCLUDED IN THE CURRENTLY APPROVED PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP USER GUIDES. THE SOF-SENSOR, PARADIGM REAL-TIME REVEL INSULIN PUMP AND PARADIGM REAL-TIME INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL- TIME SYSTEM, GUARDIAN REAL-TIME SYSTEM, AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSEMONITORING (CGM) SYSTEM.
P030017|S129|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2012|03/09/2012|||OK30|CHANGES TO THE BATTERY PROFILE DOWNLOAD SOFTWARE FOR THE DEVICE.
P910077|S119|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE WAVE COMMUNICATOR (MODEL 6498)|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/09/2012|01/28/2013|||APPR|APPROVAL FOR THE LATITUDE WAVE COMMUNICATOR AND SYSTEM SOFTWARE LATITUDE NXT SOFTWARE FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM.
P910023|S288|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE ICD SYSTEM|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2012|03/12/2012|||OK30|CHANGE TO THE RECEIVING INSPECTION SAMPLE SIZE FOR A COMPONENT.
P030054|S215|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE Q/PROMOTE QUADRA/UNIFY QUADRA/QUARTET CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2012|03/12/2012|||OK30|CHANGE TO THE RECEIVING INSPECTION SAMPLE SIZE FOR A COMPONENT.
P910023|S289|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FORTIFY FAMILY OF ICDS|NVZ|CV|30-Day Notice||N|02/13/2012|03/14/2012|||OK30|ACCEPTANCE OF OPTIMIZED BOND PARAMETERS USED IN THE HYBRID WIRE BONDING PROCESS.
P030054|S216|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY FAMILY OF CRT-DS AND LEADS|NIK|CV|30-Day Notice||N|02/13/2012|03/14/2012|||OK30|ACCEPTANCE OF OPTIMIZED BOND PARAMETERS USED IN THE HYBRID WIRE BONDING PROCESS.
P910023|S290|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT AND FORTIFY FAMILIES OF ICDS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|08/09/2012|||APPR|APPROVAL FOR THE REMOVAL OF A PLASMA CLEANING STEP FOR HYBRID SURFACE PREPARATION.
P030054|S217|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE AND UNIFY FAMILIES OF CRT-DS AND LEADS|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|08/09/2012|||APPR|APPROVAL FOR THE REMOVAL OF A PLASMA CLEANING STEP FOR HYBRID SURFACE PREPARATION.
P930014|S059|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/12/2012|||OK30|ELIMINATION OF THE IN-PROCESS QUALITY TEST FOR REFRACTIVE INDEX.
P040020|S040|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/12/2012|||OK30|ELIMINATION OF THE IN-PROCESS QUALITY TEST FOR REFRACTIVE INDEX.
P100028|S002|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|STENT, RENAL|FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM|NIN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/13/2012|04/30/2012|||APPR|APPROVAL FOR THE 4 MM VERSION OF THE STENT TO BE USED WITH THE FORMULA 414 RX DELIVERY SYSTEM.
P970008|S061|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/13/2012|||OK30|REPLACEMENT OF AN OBSOLETE PATIENT CABLE FIBER ST CONNECTOR USED IN THE MANUFACTURE OF THE TARGIS SYSTEM COOLWAVE CONTROL UNITS.
P010041|S030|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|S.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC)|DYE|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/13/2012|06/26/2012|||APPR|APPROVAL FOR THE LABELING CHANGE BASED ON THE POST-APPROVAL STUDY DATA.
P060040|S015|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/13/2012|06/05/2012|||APPR|APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO REFLECT THE POST-APPROVAL STUDY FINDINGS FOR THE BRIDGE-TO-TRANSPLANT INDICATION.
P080006|S038|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/09/2012|||OK30|ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.
P980016|S338|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/09/2012|||OK30|ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.
P980035|S260|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/09/2012|||OK30|ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.
P010015|S154|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/09/2012|||OK30|ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.
P010031|S291|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/09/2012|||OK30|ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.
P090013|S053|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2012|03/09/2012|||OK30|ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.
P890047|S038|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2012|03/12/2012|||OK30|ALTERNATE MIXER PROCESS DURING MANUFACTURING.
P840064|S050|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2012|03/12/2012|||OK30|ALTERNATE MIXER PROCESS DURING MANUFACTURING.
P110010|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2012|03/09/2012|||OK30|ADDITION OF A CATHETER MANIFOLD MOLDING LINE AT THE GALWAY MANUFACTURING FACILITY.
P100023|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2012|03/09/2012|||OK30|ADDITION OF A CATHETER MANIFOLD MOLDING LINE AT THE GALWAY MANUFACTURING FACILITY.
P960030|S035|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|PASSIVE PLUS AND IOSFLEX LEAD FAMILIES|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2012|04/13/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE CONNECTOR BOOT ON THE ISOFLEX MODELS, ISOFLEX OPTIM MODELS 1944 AND 1948.
P100046|S001|ATRICURE INC.|386 WEST MAIN STREET, SUITE 7||NORTHBOROUGH|MA|01532||Surgical cardiac ablation device, for treatment of atrial fibrillation|ATRICURE SYNERGY ABLATION SYSTEM|OCM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/14/2012|08/15/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950039|S024|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSOR 2000/3000 SYSTEM|MKQ|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/2012|04/09/2012|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FOR THINPREP PAP TEST FILTERS.
P010032|S048|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|S-SERIES LAMITRODE LEADS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/15/2012|04/10/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE ELECTRODE DESIGN ON THE S-SERIES LAMITRODE LEAD MODELS 3243, 3246, 3283, 3286, 3266 AND 3268.
P930036|S004|SIEMENS HEALTHCARE DIAGNOSTICS INC.|333 CONEY  STREET||EAST WALPOLE|MA|02032||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS|LOK|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2012|08/14/2012|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A LOT SPECIFIC MASTER CURVE IN THE QUALITY CONTROL TESTING OF THE ANTI-AFP ANTIBODY.
P000041|S011|RIVERAIN MEDICAL GROUP|3020 SOUTH TECH BLVD.||MIAMISBURG|OH|45342|4860|Analyzer,medical image|CLEAREAD DETECT|MYN|RA|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/14/2012|02/27/2012|||APPR|APPROVAL TO MARKET THE DEVICE UNDER THE ADDITIONAL TRADE NAME CLEARREAD DETECT.
P960013|S071|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL AND OPTISENSE LEAD FAMILIES|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2012|04/13/2012|||APPR|APPROVAL FOR MODIFICATION TO THE CONNECTOR BOOT ON THE ISOFLEX TENDRIL ST, TENDRIL STS, AND OPTISENSE LEAD MODELS, TENDRIL ST MODELS 1882, 1888, TENDRIL STS MODELS 1988, 2088 AND OPTISENSE MODEL 1999.
P000014|S025|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2012|03/13/2012|||OK30|1) CHANGING THE TIMINGS OF THE QA RELEASE TEST FROM SEQUENTIAL TO CONCURRENT DESCRIBED AS THE SINGLE-TEST; AND 2) REDUCING THE NUMBER OF THE ASSAYS IN THE MGCC RELEASE TEST.
P980022|S111|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SEN-SERTER, MODEL: MMT-7500|MDS|CH|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/15/2012|03/14/2012|||APPR|APPROVAL FOR LABELING CHANGES FOR THE SEN-SERVER COMPONENT OF THE DEVICE.
P900056|S112|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2012|02/29/2012|||OK30|USE OF AN ALTERNATE CLEANING AGENT FOR THE BURR PREPARATION PROCESS.
P950034|S041|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM|MCN|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2012|04/04/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GENZYME NORTHBOROUGH OPERATIONS CENTER (GNOC) IN NORTHBOROUGH, MASSACHUSETTS.
P100010|S015|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2012|04/12/2012|||APPR|APPROVAL FOR CATHETER CHANGES TO INCREASE THE UNIFORMITY OF THE DISTAL BALLOON SURFACE TEMPERATURE (INCREASED NUMBER OF REFRIGERANT PORTS ON THE INJECTION TUBE COIL, MORE DISTAL POSITION OF THE INJECTION TUBE, INCREASED REFRIGERANT FLOW ON THE 28MM BALLOON), TO ADD NEW VISUAL MARKER ON THE CATHETER SHAFT AND TO IMPLEMENT ADDITIONAL MINOR CHANGES TO THE DESIGN AND LABELING.
P080023|S013|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2012|04/13/2012|||OK30|ADD A PEROXIDE LEVEL QUALITY CONTROL TEST FOR ALL INCOMING VENDOR LOTS OF DETERGENT.
P050042|S016|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHTECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2012|04/13/2012|||OK30|ADD A PEROXIDE LEVEL QUALITY CONTROL TEST FOR ALL INCOMING VENDOR LOTS OF DETERGENT.
P020036|S023|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2012|03/22/2012|||OK30|PACKAGE HANDLING CHANGE TO THE HEAT SEALING PROCESS.
P030047|S024|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE, PRECISE RX, AND PRECISE PRO RXNITINOL STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2012|03/22/2012|||OK30|PACKAGE HANDLING CHANGE TO THE HEAT SEALING PROCESS.
P990038|S015|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2012|03/09/2012|||OK30|CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.
P990041|S014|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2012|03/09/2012|||OK30|CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.
P990042|S011|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2012|03/09/2012|||OK30|CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.
P990044|S012|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS ASSAY|LOM|MI|30-Day Notice||N|02/17/2012|03/09/2012|||OK30|CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.
P990043|S015|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK-PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2012|03/09/2012|||OK30|CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.
P990045|S012|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2012|03/09/2012|||OK30|CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES.
P050023|S052|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2012|03/15/2012|||APPR|APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE VERSION (PSW 1101.U1.
P950037|S104|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2012|03/15/2012|||APPR|APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE VERSION (PSW 1101.U1.
P000009|S048|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2012|03/15/2012|||APPR|APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE VERSION (PSW 1101.U1.
P070008|S030|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2012|03/15/2012|||APPR|APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE VERSION (PSW 1101.U1.
P860057|S086|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/22/2012|||OK30|ADD AN ALTERNATE SUPPLIER FOR CAP COMPONENTS.
P870056|S046|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOPROSTHESIS MODEL 2625 AND 6625|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/22/2012|||OK30|ADD AN ALTERNATE SUPPLIER FOR CAP COMPONENTS.
P870077|S042|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODEL# 6625LP AND 6625-ESR-LP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/22/2012|||OK30|ADD AN ALTERNATE SUPPLIER FOR CAP COMPONENTS.
P000007|S029|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/22/2012|||OK30|ADD AN ALTERNATE SUPPLIER FOR CAP COMPONENTS.
P010041|S031|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SUPRAANULAR BIOPROSTHESIS MODEL 2650|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/22/2012|||OK30|ADD AN ALTERNATE SUPPLIER FOR CAP COMPONENTS.
P100041|S007|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/22/2012|||OK30|ADD AN ALTERNATE SUPPLIER FOR CAP COMPONENTS.
P060038|S011|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/19/2012|||OK30|CHANGE A CRITICAL COMPONENT SUPPLIER.
P040045|S032|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/21/2012|||OK30|USE OF AN ALTERNATE PROCESS FOR DE-IONIZED WATER REMOVAL DURING MANUFACTURING.
P080032|S008|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/22/2012|||OK30|PROCESS CHANGES RELATED TO THE ALAIR CATHETER MODEL AS WELL AS THE ALAIR RADIOFREQUENCY CONTROLLER.
P030031|S039|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|06/15/2012|||APPR|APPROVAL FOR AN ALTERNATIVE STERILIZATION FACILITY LOCATED AT STERIGENICS US IN SANTA TERESA, NEW MEXICO.
P050047|S023|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2012|03/20/2012|||OK30|APPROVAL OF TWO CHANGES: 1) ADDITION OF A WAITING PERIOD WHILE THE GEL IS SITTING IN THE MOBILE TANK AND; 2) AN ENVIRONMENTAL CHANGE IN THE SECONDARY PACKAGING ROOM OF THE PRINGY I MANUFACTURING FACILITY.
P050012|S045|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM CGM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/21/2012|08/17/2012|||APPR|APPROVAL FOR 1) THE ADDITION OF NEW COMPONENTS TO THE GLOBAL TRANSMITTER/GLOBAL RECEIVER SYSTEM ALLOWING COMMUNICATION AT 2.4 GHZ; 2) MINOR MODIFICATIONS TO THE APPLICATOR BAIL AND SAFETY CARD; AND 3) UPDATES TO THE OPTIONAL DATA MANAGER SOFTWARE THAT IS PROVIDED WITH THE SEVEN PLUS CGM SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM COLOR CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, AND IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING AND TRACKING GLUCOSE TRENDS AND PATTERNS TO AID IN THEDETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA IN ADULTS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.
P980016|S339|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA/MAXIMO II/PROTECTA /PROTECTA XT/ENTRUST/ENTRUST DR|LWS|CV|Real-Time Process||N|02/22/2012|04/16/2012|||APPR|APPROVAL FOR AN UPDATE TO THE LIFE TEST SPECIFICATIONS OF HIGH VOLTAGE CAPACITORS.
P010031|S292|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT|NIK|CV|Real-Time Process||N|02/22/2012|04/16/2012|||APPR|APPROVAL FOR AN UPDATE TO THE LIFE TEST SPECIFICATIONS OF HIGH VOLTAGE CAPACITORS.
P980050|S070|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT|LWS|CV|Real-Time Process||N|02/22/2012|04/16/2012|||APPR|APPROVAL FOR AN UPDATE TO THE LIFE TEST SPECIFICATIONS OF HIGH VOLTAGE CAPACITORS.
P060039|S033|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/22/2012|08/16/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050038|S011|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2012|03/23/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF A CRITICAL COMPONENT USED IN THE MANUFACTURE OF THE ARISTA AH ABSORBABLE HEMOSTAT.
P050048|S007|BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2012|11/13/2012|||APPR|APPROVAL FOR THE MODIFICATION OF THE QUALITY CONTROL TESTING SPECIFICATION FOR THE 400 MIU/ML CALIBRATOR IN THE DEVICE.
P880086|S216|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, & ACCENT FAMILIES OF IPG'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2012|04/13/2012|||APPR|APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU  WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.
P030035|S094|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER, FRONTIER II, ANTHEM FAMILIES OF CRTP'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2012|04/13/2012|||APPR|APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.
P910023|S291|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|VARIOUS FAMILIES OF CURRENT, ATLAS, EPIC, CONVERT, CURRENT, & FORTIFY ICD'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2012|04/13/2012|||APPR|APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.
P030054|S218|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VARIOUS FAMILIES OF EPIC, ATLAS, PROMOTE, UNIFY CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2012|04/13/2012|||APPR|APPROVAL FOR IMPLEMENTING PALLADIUM-IRIDIUM (PD-IR) ALLOY WIRE AS AN ALTERNATE TO THE EXISTING PLATINUM-IRIDIUM (PT-IR) ALLOY FEEDTHRU WIRE IN ST. JUDE MEDICAL HIGH AND LOW VOLTAGE PULSE GENERATORS.
P110019|S014|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2012|08/20/2012|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED IN TIPPERARY. IRELAND.
P020047|S046|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS)|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2012|08/20/2012|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED IN TIPPERARY. IRELAND.
P030017|S130|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2012|04/10/2012|||APPR|APPROVAL FOR A NEW OUTER CARTON FOR THE IMPLANTABLE PULSE GENERATOR (IPG) KITS, INFINION 1X16 LEAD KITS AND 2X8 SPLITTER KITS.
P070015|S091|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V, XIENCE NANO, PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2012|03/22/2012|||OK30|EXTENSION OF STABILITY TESTING FOR A COPOLYMER USED IN THE DRUG FORMULATION OF THE DEVICES.
P110019|S015|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2012|03/22/2012|||OK30|EXTENSION OF STABILITY TESTING FOR A COPOLYMER USED IN THE DRUG FORMULATION OF THE DEVICES.
P970021|S037|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM|MNB|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2012|04/03/2013|||APPR|APPROVAL FOR A CHANGE IN THE RESIN SUPPLIER FOR THE THERMACHOICE BALLOON.
P020045|S042|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/23/2012|04/12/2012|||APPR|APPROVAL FOR A MODIFICATION TO ALLOW THE USE OF THE ARCTIC FRONT ADVANCE BALLOON CATHETER (MODELS 2AF234 & 2AF284) WITH THE CRYOCONSOLE MODEL #106A3 AND IS INDICATED FOR USE IN PERFORMING CARDIAC ABLATION PROCEDURES.
P920015|S086|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC SPRINT QUATTRO SECURE DF4 LEAD MODEL 6947M|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2012|03/21/2012|||OK30|ADD SPRINT QUATTRO SECURE LEAD MODEL 6974M TO PREVIOUSLY APPROVED 30-DAY NOTICE SUBMISSIONS REGARDING STERILE PACKAGING PROCESS CHANGES.
P080006|S039|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY, ATTAIN ABILITY PLUS & ATTAIN ABILITY STRAIGHT|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2012|03/16/2012|||OK30|CHANGE TO THE LASER ABLATION PROCES
P980022|S112|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2012|04/27/2012|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS (VERSION 2.5A) AND RELATED LABELING MODIFICATIONS FOR THE PARADIGM REAL-TIME REVEL PUMP (MODELS MMT-532, MMT-723, MMT-523K, MMT723K).  THE PARADIGM REVEL INSULIN PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME REVEL SYSTEM.
P040038|S024|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/27/2012|07/24/2012|||APPR|APPROVAL FOR THE ADDITION OF THE PROTECT POST-APPROVAL STUDY (PAS) RESULTS TO THE INSTRUCTIONS FOR USE (IFU).
P980022|S113|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP AND PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2012|04/18/2012|||APPR|APPROVAL FOR AN ALTERNATE SUPERCAPACITOR, A COMPONENT USED ON THE INTERFACE BOARDS OF THE PARADIGM REAL-TIME PUMP (MODELS MMT-522, -522K, -722, 722K) AND PARADIGM REAL-TIME REVEL PUMP (MODELS MMT-523, -523K, -723, -723K) WHICH ARE COMPONENTS OF THE DEVICES.
P920015|S087|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE LEAD (DF4)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2012|03/26/2012|||OK30|ADD AUTOMATION OT THE LEAD ASSEMBLY PROCESS.
P890003|S245|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARELINK HOME MONITOR MODEL 2491|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2012|03/22/2012|||APPR|APPROVAL FOR A PROPOSED SOFTWARE CHANGE PERTAINING TO FIVE EXTENSIBLE MARK-UP LANGUAGE TRANSLATION UTILITIES (XMLTU) FOR THE FOLLOWING DEVICE FAMILIES: ENTRUST, ENRHYTHM, REVO MRI, PROTECTA, CONCERTO AND VIRTUOSO.
P980016|S340|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST / VIRTUOSO / PROTECTA|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2012|03/22/2012|||APPR|APPROVAL FOR A PROPOSED SOFTWARE CHANGE PERTAINING TO FIVE EXTENSIBLE MARK-UP LANGUAGE TRANSLATION UTILITIES (XMLTU) FOR THE FOLLOWING DEVICE FAMILIES: ENTRUST, ENRHYTHM, REVO MRI, PROTECTA, CONCERTO AND VIRTUOSO.
P980035|S261|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM / ENRHYTHM MRI|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2012|03/22/2012|||APPR|APPROVAL FOR A PROPOSED SOFTWARE CHANGE PERTAINING TO FIVE EXTENSIBLE MARK-UP LANGUAGE TRANSLATION UTILITIES (XMLTU) FOR THE FOLLOWING DEVICE FAMILIES: ENTRUST, ENRHYTHM, REVO MRI, PROTECTA, CONCERTO AND VIRTUOSO.
P090013|S054|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2012|03/22/2012|||APPR|APPROVAL FOR A PROPOSED SOFTWARE CHANGE PERTAINING TO FIVE EXTENSIBLE MARK-UP LANGUAGE TRANSLATION UTILITIES (XMLTU) FOR THE FOLLOWING DEVICE FAMILIES: ENTRUST, ENRHYTHM, REVO MRI, PROTECTA, CONCERTO AND VIRTUOSO.
P010031|S293|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO / PROTECTA|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2012|03/22/2012|||APPR|APPROVAL FOR A PROPOSED SOFTWARE CHANGE PERTAINING TO FIVE EXTENSIBLE MARK-UP LANGUAGE TRANSLATION UTILITIES (XMLTU) FOR THE FOLLOWING DEVICE FAMILIES: ENTRUST, ENRHYTHM, REVO MRI, PROTECTA, CONCERTO AND VIRTUOSO.
P020047|S047|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|02/28/2012|03/23/2012|||OK30|NEW HEAT SEALER FOR FINISHED GOODS PACKAGING.
P970020|S073|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK OTW ULTRA & MULTI-LINK RX ULTRA CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|02/28/2012|03/23/2012|||OK30|NEW HEAT SEALER FOR FINISHED GOODS PACKAGING.
N18033|S064|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice||N|02/28/2012|03/26/2012|||OK30|USE AN ALTERNATE PROCESS FOR REMOVING THE BACK CURVE PLASTIC MOLD FROM THE CURED LENS DURING MANUFACTURING.
P020014|S037|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM|HHS|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|05/17/2012|||OK30|REPLACE THE CURRENT MANUAL DEPLOY AND DETACH TEST FIXTURE WITH AN AUTOMATED TEST FIXTURE FOR LOT RELEASE TESTING OF HE ESSURE SYSTEM.
P060040|S016|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LVAS|DSQ|CV|Special (Immediate Track)||N|02/28/2012|03/29/2012|||APPR|APPROVAL FOR PROVIDING ADDITIONAL INFORMATION IN THE LABELING REGARDING PROPER ENGAGEMENT OF THE BEND RELIEF WITH THE SEALED OUTFLOW GRAFT OF THE DEVICE AT THE TIME OF IMPLANT.
P030016|S023|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|IMPLANTABLE COLLAMER LENS (VISIAN ICL)|MTA|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/29/2012|06/08/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860008|S021|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|TAPSCOPE 550|LPA|CV|135 Review Track For 30-Day Notice||N|02/29/2012|06/05/2012|||APPR|APPROVAL OF A NEW SUPPLIER FOR THE MOLDING OF THE PACING WIRE CONNECTOR AND REVISION TO THE MANUFACTURING PROCESS OF THE PACING WIRE ASSEMBLY.
P950020|S049|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CORONARY FLEXTOME CUTTING BALLOON||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2012|03/30/2012|||OK30|CHANGE TO THE MANUFACTURING PROCESS EQUIPMENT AT THE PLYMOUTH FACILITY.
P810002|S081|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|ELIMINATING THE USE OF ONE METHOD FOR COATING THICKNESS IMAGE CAPTURE AND REPLACING IT WITH A NEW METHOD.
P990056|S017|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA|MTF|IM|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER THE REWORK LOCATION FROM BUILDING R TO A CONNECTED BUILDING W2 ON THE INDIANAPOLIS CAMPUS FOR THE DEVICE.
P000027|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA|MTG|IM|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER THE REWORK LOCATION FROM BUILDING R TO A CONNECTED BUILDING W2 ON THE INDIANAPOLIS CAMPUS FOR THE DEVICE.
P990012|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG|LOM|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P010054|S019|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS|LOM|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P100031|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170|LOM|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P100032|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC ON ELECSYS 2010|LOM|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P090007|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV ON COBAS E 411|MZO|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P090008|S009|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV ON COBAS E 601|MZO|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P090009|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170|MZO|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P110022|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ON COBAS E 601|LOM|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P110025|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170|LOM|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P110031|S006|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ON COBAS E 411|LOM|MI|30-Day Notice||N|02/29/2012|03/28/2012|||OK30|TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
P040001|S020|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP INTERSPINOUS SPACER SYSTEM|NQO|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2012|07/25/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SOFAMOR DANEK USA, INC. IN MEMPHIS, TENNESSEE.
P880086|S217|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2012|03/21/2012|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE AFFINITY/ INTEGRITY/VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS.
P030035|S095|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2012|03/21/2012|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH FRONTIER/ FRONTIER IV; ANTHEM FAMILY OF CRT-PS.
P880006|S078|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2012|03/21/2012|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS.
P970013|S047|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2012|03/21/2012|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE MICRONY FAMILY OF PACEMAKERS.
P910023|S293|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/CURRENT FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2012|03/21/2012|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE CADENCE/ CURRENT FAMILY OF ICDS.
P030054|S220|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+ HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2012|03/21/2012|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS.
P980016|S341|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|4195 ATTAIN STARFIX|LWS|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P060039|S034|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|4195 ATTAIN STARFIX|NVY|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P850089|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|INSYNC ICD MODEL 7272|NVY|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P930039|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|4068 CAPSUREFIX|NVY|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P080006|S040|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|4196 ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P890003|S246|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ACTIVITRAX|NVZ|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P950024|S041|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|4965 EPICARDIAL LEAD|NVY|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P010015|S155|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC MODEL 8040 PULSE GENERATOR|OJX|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P090013|S055|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P900061|S112|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|7261A PCD|LWS|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P980035|S262|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P010031|S294|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC ICD MODEL 7272||CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P820003|S115|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|KAPPA 700|LWP|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P920015|S088|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEADS|LWS|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P980050|S071|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF MODEL 7250|LWS|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P030036|S041|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE|NVY|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P830061|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|4003/4503 CAPSURE|NVY|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P930029|S036|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RFCA SYSTEM|LPB|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P990001|S101|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON|NVZ|CV|30-Day Notice||N|02/29/2012|03/23/2012|||OK30|UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.
P790007|S032|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2012|01/10/2013|||APPR|APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.
P870078|S015|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY CONDUIT MODEL 105|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2012|01/10/2013|||APPR|APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.
P970031|S036|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2012|01/10/2013|||APPR|APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.
P980043|S034|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2012|01/10/2013|||APPR|APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.
P990064|S041|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2012|01/10/2013|||APPR|APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.
P960040|S253|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES|LWP|CV|30-Day Notice||N|03/01/2012|03/30/2012|||OK30|REMOVE AN INSERTION FORCE PROCESS MONITOR.
P010012|S283|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|30-Day Notice||N|03/01/2012|03/30/2012|||OK30|REMOVE AN INSERTION FORCE PROCESS MONITOR.
P010012|S284|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|30-Day Notice||N|03/01/2012|03/28/2012|||OK30|USE OF A NEW INSULATOR TAPE USED IN THE HIGH VOLTAGE CAPACITOR.
P960040|S254|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES|LWP|CV|30-Day Notice||N|03/01/2012|03/28/2012|||OK30|USE OF A NEW INSULATOR TAPE USED IN THE HIGH VOLTAGE CAPACITOR.
P070022|S028|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Laparoscopic contraceptive tubal occlusion device|ADIANA PERMANENT CONTRACEPTION SYSTEM|KNH|OB|30-Day Notice||N|03/01/2012|03/28/2012|||OK30|MINOR CHANGES TO THE MANUFACTURING PROCEDURE OF THE CATHETER TIP FOR THE DEVICE.
P040013|S018|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)|NPZ|DE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/29/2012|07/11/2014|||APPR|APPROVAL FOR THE REVISION OF THE GEM 21S PACKAGE INSERT.
P070008|S031|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2012|10/03/2012|||APPR|APPROVAL FOR THE EVIA HF/HF-T FAMILY OF CRT-PS AND NEW  PROGRAMMER SOFTWARE IDENTIFIED AS 1203.U/1.
P950037|S105|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2012|10/03/2012|||APPR|APPROVAL FOR THE EVIA HF/HF-T FAMILY OF CRT-PS AND NEW PROGRAMMER SOFTWARE IDENTIFIED AS 1203.U/1.
P000009|S049|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2012|10/03/2012|||APPR|APPROVAL FOR THE EVIA HF/HF-T FAMILY OF CRT-PS AND NEW  PROGRAMMER SOFTWARE IDENTIFIED AS 1203.U/1.
P050023|S053|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2012|10/03/2012|||APPR|APPROVAL FOR THE EVIA HF/HF-T FAMILY OF CRT-PS AND NEW  PROGRAMMER SOFTWARE IDENTIFIED AS 1203.U/1.
P990009|S033|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/02/2012|07/25/2012|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE FLOSEAL HEMOSTATIC MATRIX 5ML KIT CONFIGURATION: MODIFIED BOWL, PRE-FILLED SYRINGE OF SODIUM CHLORIDE SOLUTION, AND INCLUSION OF A NEEDLE-FREE VIAL ADAPTER.
P040043|S046|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|03/05/2012|04/04/2012|||OK30|ADDITION OF NEW EQUIPMENT TO THE STENT WINDING PROCESS.
P030017|S131|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice||N|03/05/2012|04/04/2012|||OK30|MOVE THE CHARGER ASSEMBLY PROCESS FROM A VENDOR, TO IN-HOUSE AND INSTALL NEW EQUIPMENT TO IMPLEMENT THE CHANGE.
P960011|S021|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BVI 1% OVD (!% SODIUM HYALURONATE VICSCOELASTIC SURGICAL AID FLUID|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|03/30/2012|||OK30|ALTERNATE USE OF A NEW SYRINGEABILITY MACHINE FOR QC TESTING.
P010029|S014|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|03/30/2012|||OK30|ALTERNATE USE OF A NEW SYRINGEABILITY MACHINE FOR QC TESTING.
P110010|S008|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|04/03/2012|||OK30|MANUFACTURING EQUIPMENT CHANGE FOR THE DRUG SPRAYING PROCESS.
P870056|S047|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300|DYE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2012|04/04/2012|||APPR|APPROVAL FOR ADDING TEXT TO THE WARNINGS AND COMPLICATIONS SECTIONS OF THE EDWARDS MODEL 4300 VALVED CONDUIT IFU IN ORDER TO STRENGTHEN THESE STATEMENTS.
P980022|S114|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP|MDS|CH|30-Day Notice||N|03/05/2012|04/04/2012|||OK30|USE OF AN ALTERNATIVE SUPERCAPACITOR DUE TO A SUPPLY CHAIN PROBLEM. THESUPERCAPACITOR 1037110-003 (NEC P/N:  FGH0H154ZF-H5E) WILL REPLACE 1037110-002 (NECPIN: FGH0H154ZF-LE) FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, -522K,-722, -722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT -523, -523K, -723,-723K). THE PARADIGM REAL-TIME PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM. THE PARADIGM REAL-TIME REVEL PUMP IS A COMPONENT OF THEPARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM.
P990025|S030|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER NAV ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice||N|03/02/2012|03/30/2012|||OK30|CHANGE IN CALIBRATION AND CALIBRATION CHECK MANUFACTURING PROCESSES PI-008-01 AND PI-008-02 TO INCORPORATE THE CATHETER CALIBRATION SYSTEM AS AN ALTERNATIVE TO THE HELMHOLTZ CALIBRATION SYSTEM.
P010068|S026|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS ELECTROPHYSIOLOGY CATHETER|OAD|CV|30-Day Notice||N|03/02/2012|03/30/2012|||OK30|CHANGE IN CALIBRATION AND CALIBRATION CHECK MANUFACTURING PROCESSES PI-008-01 AND PI-008-02 TO INCORPORATE THE CATHETER CALIBRATION SYSTEM AS AN ALTERNATIVE TO THE HELMHOLTZ CALIBRATION SYSTEM.
P030031|S040|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER  THERMOCOOL NAV  CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER|LPB|CV|30-Day Notice||N|03/02/2012|03/30/2012|||OK30|CHANGE IN CALIBRATION AND CALIBRATION CHECK MANUFACTURING PROCESSES PI-008-01 AND PI-008-02 TO INCORPORATE THE CATHETER CALIBRATION SYSTEM AS AN ALTERNATIVE TO THE HELMHOLTZ CALIBRATION SYSTEM.
P040036|S029|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER  THERMOCOOL NAV  CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice||N|03/02/2012|03/30/2012|||OK30|CHANGE IN CALIBRATION AND CALIBRATION CHECK MANUFACTURING PROCESSES PI-008-01 AND PI-008-02 TO INCORPORATE THE CATHETER CALIBRATION SYSTEM AS AN ALTERNATIVE TO THE HELMHOLTZ CALIBRATION SYSTEM.
P980035|S263|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|04/02/2012|||OK30|REMOVAL OF PARALLEL GAP WELDING LINE TESTING FOR SELECT PLATED COMPONENTS.
P980016|S342|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM DR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|04/02/2012|||OK30|REMOVAL OF PARALLEL GAP WELDING LINE TESTING FOR SELECT PLATED COMPONENTS.
P990001|S102|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|04/02/2012|||OK30|REMOVAL OF PARALLEL GAP WELDING LINE TESTING FOR SELECT PLATED COMPONENTS.
P010015|S156|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC MODEL 8040 PULSE GENERATOR|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|04/02/2012|||OK30|REMOVAL OF PARALLEL GAP WELDING LINE TESTING FOR SELECT PLATED COMPONENTS.
P010031|S295|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC ICD MODEL 7272||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|04/02/2012|||OK30|REMOVAL OF PARALLEL GAP WELDING LINE TESTING FOR SELECT PLATED COMPONENTS.
P090013|S056|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2012|04/02/2012|||OK30|REMOVAL OF PARALLEL GAP WELDING LINE TESTING FOR SELECT PLATED COMPONENTS.
P980007|S025|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2012|03/22/2012|||OK30|ADDITION OF AN ABSORBANCE TEST TO CONFIRM ABBOTT¿S CLAIM OF 70% DETERGENT (TRITON X-405) CONCENTRATION TO VERIFY CONFORMANCE OF INCOMING PRODUCT.
P910007|S034|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2012|03/22/2012|||OK30|ADDITION OF AN ABSORBANCE TEST TO CONFIRM ABBOTT¿S CLAIM OF 70% DETERGENT (TRITON X-405) CONCENTRATION TO VERIFY CONFORMANCE OF INCOMING PRODUCT.
P050037|S032|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2012|11/08/2012|||APPR|APPROVAL FOR A CHANGE TO SYRINGE ASSEMBLY.
P050052|S035|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice||N|03/06/2012|11/08/2012|||APPR|APPROVAL FOR A CHANGE TO SYRINGE ASSEMBLY.
P100010|S016|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|AORTIC FRONT CARDIAC CRYOABLATION CATHETERS|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2012|04/04/2012|||OK30|CHANGE TO THE APPLICATION OF ADHESIVE AND THE ADDITION OF AN INSPECTION TOOLS.
P930014|S060|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF #81 MODIFIED LENS CASES|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2012|04/25/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE ACRYSOF® INTRAOCULAR LENS (IOL) CASE (#81) DRAINAGE FEATURES.
P990009|S034|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2012|07/25/2012|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE FLOSEAL HEMOSTATIC MATRIX10ML KIT CONFIGURATION: INCLUSION OF MALLEABLE TIP; APPLICATOR; MODIFIED BOWL; PRE-FILLED SYRINGE OF SODIUM CHLORIDE SOLUTION; VIAL OF THROMBIN (5000 UNITS); AND INCLUSION OF A NEEDLE-FREE VIAL ADAPTER.
P080012|S001|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/06/2012|05/03/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P080012|S002|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/06/2012|05/04/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P080012|S003|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/06/2012|05/04/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P000053|S041|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS SPHINCTER 800 URINARY PROSTHESIS|EZY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2012|08/21/2012|||APPR|APPROVAL FOR REVISION OF THE AMOUNT OF RIFAMPIN AND MINOCYCLINE SPECIFIED IN THE INSTRUCTION FOR USE AND THE OPERATING ROOM MANUAL.
P950032|S068|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2012|04/03/2012|||APPR|APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELL STRAIN (HEP 170) INTO THE MANUFACTURE OF APLIGRAF.
P010031|S296|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERT II, CONSULTA, & MAXIMO II CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2012|06/04/2012|||APPR|APPROVAL FOR CONCERTO II CRT-D MODEL D274TRK, CONSULTA CRT-D MODELS D204TRM AND D224TRK AND MAXIMO II CRT-D MODELS D264TRM AND D284TRK.
P980016|S343|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II, SECURA & VIRTUOSO II DR/VR ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2012|06/04/2012|||APPR|APPROVAL FOR MAXIMO II ICD MODELS D264DRM, D284DRG, D284VRC; SECURA ICD MODELS D204DRM, D224DRG, D224VRC; AND VIRTUOSO II DR/VR ICD MODELS D274DRG AND D274VRC.
P890003|S247|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK DEVICE DATA MANAGEMENT APPLICATION (MODEL 2491)|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2012|06/04/2012|||APPR|APPROVAL FOR DDMA SOFTWARE MODEL 2491.
P980035|S264|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2012|06/04/2012|||APPR|ADVISA DR IPG MODEL A4DR01 AND APPLICATION SOFTWARE MODEL 9995 VERSION 7.4 FOR CARELINK PROGRAMMER MODEL 2090.
P010015|S157|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2012|06/04/2012|||APPR|APPROVAL FOR  CONSULTA CRT-P MODEL C4TR01 AND SYNCRA CRT-P MODEL C2TR01.
P010015|S158|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC MODEL 8040 PULSE GENERATOR|OJX|CV|30-Day Notice||N|03/07/2012|04/02/2012|||OK30|VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
P010031|S297|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNC ICD MODEL 7272||CV|30-Day Notice||N|03/07/2012|04/02/2012|||OK30|VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
P090013|S057|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|30-Day Notice||N|03/07/2012|04/02/2012|||OK30|VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
P890003|S248|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ACTIVITRAX|NVZ|CV|30-Day Notice||N|03/07/2012|04/02/2012|||OK30|VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
P920015|S089|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEADS|LWS|CV|30-Day Notice||N|03/07/2012|04/02/2012|||OK30|VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
P980016|S344|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM DR|LWS|CV|30-Day Notice||N|03/07/2012|04/02/2012|||OK30|VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
P980035|S265|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 700|NVZ|CV|30-Day Notice||N|03/07/2012|04/02/2012|||OK30|VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
P990001|S103|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON|NVZ|CV|30-Day Notice||N|03/07/2012|04/02/2012|||OK30|VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
P970003|S146|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/08/2012|11/26/2013|||APPR|REQUESTED APPROVAL FOR A LABELING UPDATE TO INCLUDE THE RESULTS OF THE D-21 POST APPROVALSTUDY.
P000021|S022|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2012|03/16/2012|||OK30|DISCONTINUATION OF AN ABSORBANCE TEST PERFORMED ON NYLON-SURLYN FILM AND SURLYN FILM PRIOR TO RELEASE OF THE FILM FOR SLITTING AND CUVETTE FILM CANISTER ASSEMBLY.
P020027|S018|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2012|03/16/2012|||OK30|DISCONTINUATION OF AN ABSORBANCE TEST PERFORMED ON NYLON-SURLYN FILM AND SURLYN FILM PRIOR TO RELEASE OF THE FILM FOR SLITTING AND CUVETTE FILM CANISTER ASSEMBLY.
P990046|S027|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|Special (Immediate Track)||N|03/08/2012|04/03/2012|||APPR|APPROVAL FOR ADDING TEXT TO THE OPEN PIVOT AORTIC VALVED GRAFT INSTRUCTIONS FOR USE (IFU) TO STRENGTHEN THE CAUTERIZATION PRECAUTION STATEMENT.
P980022|S115|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK TRANSMITTER (MMT-7703) AND CGMS IPRO RECORDER (MMT-7709)|MDS|CH|Real-Time Process||N|03/08/2012|04/26/2012|||APPR|APPROVAL FOR A CHANGE FROM A SINGLE CAVITY INJECTION MOLD TO A TWO CAVITYINJECTION MOLD FOR THE MANUFACTURE OF THE CONNECTOR HOUSING AND CONTACT COMPONENTS OF THE MINILINK TRANSMITTER (MMT-7703) AND IPRO DIGITAL RECORDER (MMT-7709). THE MINILINK TRANSMITTER AND IPRO DIGITAL RECORDER ARE COMPONENTS OF PARADIGM REAL-TIME, GUARDIANREAL-TIME AND IPRO CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P100041|S008|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/08/2012|08/20/2012|||APPR|APPROVAL TO ADD THE EDWARDS TRANSCATHETER BALLOON CATHETERS, MODELS 9350BC20 AND 9350BC23 WITH A WORKING BALLOON LENGTH OF 4 CM, AND TO ADD SOME NEW CONTROL ENVIRONMENTS AT THE DRAPER FACILITY IN DRAPER, UTAH TO ACCOMMODATE THE MANUFACTURE OF THESE CATHETERS AT THAT FACILITY.
P090013|S058|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2012|04/04/2012|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS FOR THE MANUFACTURER OF SILICONE COMPONENTS.
P030036|S042|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2012|04/04/2012|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS FOR THE MANUFACTURER OF SILICONE COMPONENTS.
P980035|S266|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA VERSA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2012|04/04/2012|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS FOR THE MANUFACTURER OF SILICONE COMPONENTS.
P980016|S345|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2012|04/04/2012|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS FOR THE MANUFACTURER OF SILICONE COMPONENTS.
P930039|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD & VITATRON CRYSTALLINE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2012|04/04/2012|||OK30|ADDITION OF TWO ALTERNATE SUPPLIERS FOR THE MANUFACTURER OF SILICONE COMPONENTS.
N12159|S030|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICAL SNOW ABSORBABLE HEMOSTAT|LMG|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2012|04/26/2012|||APPR|APPROVAL FOR LABELING CHANGES INCLUDING UPDATED GRAPHICS, INSTRUCTIONS FOR USE, AND LANGUAGE TRANSLATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGICEL SNOW ABSORBABLE HEMOSTAT AND IS INDICATED FOR:  SURGICEL ABSORBABLE HEMOSTAT (OXIDIZED REGENERATED CELLULOSE) IS USED ADJUNCTIVELY IN SURGICAL PROCEDURES TO ASSIST IN THE CONTROL OF CAPILLARY, VENOUS, AND SMALL ARTERIAL HEMORRHAGE WHEN LIGATION OR OTHER CONVENTIONAL METHODS OF CONTROL ARC IMPRACTICAL OR INEFFECTIVE. SURGICEL ORIGINAL, SURGICEL FIBRILLAR, SURGICEL NUKNIT AND SURGICEL SNOW HEMOSTATS CAN BE CUT TO SIZE FOR USE IN ENDOSCOPIC PROCEDURES.  SURGICEL ABSORBABLE HEMOSTAT (OXIDIZED REGENERATED CELLULOSE) IS INDICATED FOR ADJUNCTIVE USE TO ASSIST IN THE CONTROL OF BLEEDING IN EXODONTIA AND ORAL SURGERY. IT MAY ALSO BE USED TO HELP ACHIEVE HEMOSTASIS AFTER SINGLE OR MULTIPLE TOOTH EXTRACTIONS, ALVEOLOPLASTY, GINGIVAL HEMORRHAGE, IMPACTIONS, BIOPSIES, AND OTHER PROCEDURES IN THE ORAL CAVITY.
P030002|S027|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS|MJP|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/2012|05/20/2013|13M-0724|06/18/2013|APPR|APPROVAL FOR THE TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODELS: AT50T, BL1AT AND BL1UT) AND TRULIGN TORIC CALCULATOR.  THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA AND POSTOPERATIVE REFRACTIVE ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA WHO DESIRE REDUCTION OF RESIDUAL REFRACTIVE CYLINDER WITH INCREASED SPECTACLE INDEPENDENCE ANDIMPROVED UNCORRECTED NEAR, INTERMEDIATE AND DISTANCE VISION.
P090013|S059|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN 5086MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2012|04/23/2012|||APPR|APPROVAL FOR A CHANGE TO THE PACKAGE CONFIGURATION FOR THE MODEL 5086 MRI SURESCAN LEAD.
P930014|S061|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2012|04/11/2012|||OK30|USE OF A FIVE-STANDARD PALLET LOAD.
P040020|S041|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2012|04/11/2012|||OK30|USE OF A FIVE-STANDARD PALLET LOAD.
P020050|S007|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EXCIMER LASER SYSTEMS|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2012|04/11/2012|||OK30|APPROVAL OF A PMA SUPPLEMENT FOR THE FOLLOWING THREE CHANGES FROM THE ANNUAL REPORT, 2011:  1) ALTERNATE SOURCE SUPPLIER FOR VENTILATOR; 2) MODIFIED PACKAGING OF OPTICAL ELEMENTS: AND 3) NEW SUPPLIER FOR SMART CARDS.
P030008|S007|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEMS|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2012|04/11/2012|||OK30|APPROVAL OF A PMA SUPPLEMENT FOR THE FOLLOWING THREE CHANGES FROM THE ANNUAL REPORT, 2011:  1) ALTERNATE SOURCE SUPPLIER FOR VENTILATOR; 2) MODIFIED PACKAGING OF OPTICAL ELEMENTS: AND 3) NEW SUPPLIER FOR SMART CARDS.
P100044|S001|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL MINI SINUS IMPLANT|OWO|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/12/2012|09/21/2012|||APPR|APPROVAL FOR A SHORTENED VERSION OF THE DRUG-ELUTING SINUS STENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROPEL MINI SINUS IMPLANT AND IS INDICATED FOR USE IN PATIENTS >= 18 YEARS OF AGE FOLLOWING ETHMOID SINUS SURGERY TO MAINTAIN PATENCY, THEREBY REDUCING THE NEED FOR POST-OPERATIVE INTERVENTION SUCH AS SURGICAL ADHESION LYSIS AND/OR USE OF ORAL STEROIDS. THE PROPEL MINI SINUS IMPLANT SEPARATES MUCOSAL TISSUES, PROVIDES STABILIZATION OF THE MIDDLE TURBINATE, PREVENTS OBSTRUCTION BY ADHESIONS, AND REDUCES EDEMA.
P110019|S016|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2012|04/09/2012|||OK30|MODIFICATION OF SAMPLING FOR DEGRADATION PRODUCTS.
P810002|S082|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|MECHANICAL HEART VALVES|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2012|07/25/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE WOODBRIDGE CLEAN ACCESS ENVIRONMENT.
P070001|S012|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC -C TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2012|12/22/2014|||APPR|APPROVAL FOR A CHANGE IN MANUFACTURING OF THE PACKAGING.
P010012|S285|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNTUA CRT-DS|LWP|CV|30-Day Notice||N|03/13/2012|04/11/2012|||OK30|CHANGE TO THE THERMAL PROCESSING OF COMPONENTS AND A CHANGE IN SUPPLIERS.
P960040|S255|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNTUA IDCS|LWP|CV|30-Day Notice||N|03/13/2012|04/11/2012|||OK30|CHANGE TO THE THERMAL PROCESSING OF COMPONENTS AND A CHANGE IN SUPPLIERS.
P000036|S008|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2012|04/18/2012|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT FLEXMEDICAL, IN TIJUANA, BAJA CALIFORNIA, MEXICO AND ADVANCED BIOHEALING INC., IN SAN DIEGO, CALIFORNIA.
P060027|S038|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF CRT-D|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/2012|05/09/2013|||APPR|APPROVAL FOR THE SMARTVIEW HOME MONITOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTVIEW HOME MONITOR AND IS INDICATED FOR USE WITH SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY AND ANY HOUSEHOLD TRADITIONAL (ANALOG TYPE) TELEPHONE LAND LINE; IT WILL NOT OPERATE WITH OTHER LINES SUCH AS AND NOT LIMITED TO DIGITAL, DSL OR OPTICAL FOR THE PSTN DEVICE AND THE SMARTVIEW MONITOR IS DESIGNED FOR USE WITH THE SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY FOR GPRS DEVICES.
P980049|S071|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM RF VR ICDS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/2012|05/09/2013|||APPR|APPROVAL FOR THE SMARTVIEW HOME MONITOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTVIEW HOME MONITOR AND IS INDICATED FOR USE WITH SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY AND ANY HOUSEHOLD TRADITIONAL (ANALOG TYPE) TELEPHONE LAND LINE; IT WILL NOT OPERATE WITH OTHER LINES SUCH AS AND NOT LIMITED TO DIGITAL, DSL OR OPTICAL FOR THE PSTN DEVICE AND THE SMARTVIEW MONITOR IS DESIGNED FOR USE WITH THE SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY FOR GPRS DEVICES.
P070015|S092|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/12/2012|04/13/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880047|S019|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECAR INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2012|04/10/2012|||OK30|CHANGE IN THE CONTRACT LABORATORY USED FOR DOSE AUDIT TESTING.
P090022|S011|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/14/2012|06/11/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE OPTIC BODY SHAPE AND OVERALLDIAMETER OF YOUR SOFTEC HD LENS TO INTRODUCE A LENS WITH AN OVOID OPTIC AND OVERALL DIAMETER OF 12.50 MM AND CHANGES TO YOUR LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICA- TION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS  INDICATED FOR CAPSULAR BAG PLACEMENT.
P970003|S147|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM GENERATORS|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2012|04/13/2012|||OK30|INTRODUCTION OF AN ADDITIONAL RECEIVING INSPECTION FOR THE TORQUE WRENCH THAT IS PACKAGED WITH THE VNS THERAPY SYSTEM GENERATORS.
P010033|S020|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON -TB GOLD|NCD|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/11/2012|11/15/2012|||APPR|APPROVAL FOR A CHANGE IN THE FORMULATION OF THE WASH BUFFER 20X CONCENTRATE.
P990064|S042|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2012|04/13/2012|||OK30|SOFTWARE MODIFICATION TO THE STENT MACHINING PROCESS.
P980043|S035|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2012|04/13/2012|||OK30|SOFTWARE MODIFICATION TO THE STENT MACHINING PROCESS.
P100023|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|03/15/2012|04/13/2012|||OK30|ALTERNATIVE PROCESS FOR THE MANUFACTURING OF CATHETER ASSEMBLIES.
P110010|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|03/15/2012|04/13/2012|||OK30|ALTERNATIVE PROCESS FOR THE MANUFACTURING OF CATHETER ASSEMBLIES.
P980041|S017|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/2012|04/13/2012|||APPR|APPROVAL FOR NEW INFORMATION TO BE ADDED TO THE INSTRUCTIONS FOR USE, THE OPERATORS GUIDE AND THE REFERENCE MANUAL, INCLUDING THE FOLLOWING: 1) ADD INSTRUCTIONS TO THE WEEKLY MAINTENANCE SECTIONS OF THESE DOCUMENTS FOR THE INSPECTION OF THE LIQUID WASTE BOTTLES;  2) CLARIFY PACK MIXING INSTRUCTIONS; 3) ADD TROUBLESHOOTING STEPS;  4) CHANGE CAUTIONS INTO WARNINGS; AND 5) CHANGE NOTES INTO WARNINGS.
P970038|S016|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/2012|04/13/2012|||APPR|APPROVAL FOR NEW INFORMATION TO BE ADDED TO THE INSTRUCTIONS FOR USE, THE OPERATORS GUIDE AND THE REFERENCE MANUAL, INCLUDING THE FOLLOWING: 1) ADD INSTRUCTIONS TO THE WEEKLY MAINTENANCE SECTIONS OF THESE DOCUMENTS FOR THE INSPECTION OF THE LIQUID WASTE BOTTLES;  2) CLARIFY PACK MIXING INSTRUCTIONS; 3) ADD TROUBLESHOOTING STEPS;  4) CHANGE CAUTIONS INTO WARNINGS; AND 5) CHANGE NOTES INTO WARNINGS.
P850048|S027|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/15/2012|04/13/2012|||APPR|APPROVAL FOR NEW INFORMATION TO BE ADDED TO THE INSTRUCTIONS FOR USE, THE OPERATORS GUIDE AND THE REFERENCE MANUAL, INCLUDING THE FOLLOWING: 1) ADD INSTRUCTIONS TO THE WEEKLY MAINTENANCE SECTIONS OF THESE DOCUMENTS FOR THE INSPECTION OF THE LIQUID WASTE BOTTLES;  2) CLARIFY PACK MIXING INSTRUCTIONS; 3) ADD TROUBLESHOOTING STEPS;  4) CHANGE CAUTIONS INTO WARNINGS; AND 5) CHANGE NOTES INTO WARNINGS.
P000036|S009|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|30-Day Notice||N|03/16/2012|04/12/2012|||OK30|ADDITIONAL 50-WATT LASER SYSTEM FOR CUTTING DERMAGRAFT FINAL PRODUCT SAMPLES.
P890055|S039|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/16/2012|04/30/2012|||APPR|APPROVAL FOR CONTROL UNIT CIRCUITRY HARDWARE MODIFICATIONS WHICH INCLUDED POTENTIOMETER VALUE CHANGE, RESISTANCE VALUE CHANGE AND CAPACITOR TOLERANCE NARROWING.
P960043|S077|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE A T 6F & PERCLOSE PROGLIDE (PROGLIDE)|MGB|CV|30-Day Notice||N|03/16/2012|04/10/2012|||OK30|CHANGE IN FINAL ACCEPTANCE TENSILE TESTING ACTIVITIES.
P050012|S046|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2012|12/14/2012|||APPR|APPROVAL TO ADD AN ADDITIONAL SEALER IN THE POUCH SEALING PROCESS USED TO SEAL THE DEXCOM SEVEN SENSORS INTO TYVEK POROUS POUCHES.
P840001|S205|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL|LGW|NE|30-Day Notice||N|03/16/2012|04/12/2012|||OK30|ADD TWO ALTERNATE SUPPLIERS FOR THE OUTER SEAL COMPONENT.
P960009|S137|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|1X4 POCKET ADAPTOR KIT, 2X4 POCKET ADAPTOR KIT, ACTIVA SC, KINETRA, SOLETRA, INTERSTIM|MHY|NE|30-Day Notice||N|03/16/2012|04/12/2012|||OK30|ADD TWO ALTERNATE SUPPLIERS FOR THE OUTER SEAL COMPONENT.
P970004|S130|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice||N|03/16/2012|04/12/2012|||OK30|ADD TWO ALTERNATE SUPPLIERS FOR THE OUTER SEAL COMPONENT.
P080025|S027|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice||N|03/16/2012|04/12/2012|||OK30|ADD TWO ALTERNATE SUPPLIERS FOR THE OUTER SEAL COMPONENT.
P060033|S069|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/19/2012|07/31/2012|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (WITH THE LATEST AVAILABLE FOLLOW-UP CLINICAL DATA FROM THE ENDEAVOR CLINICAL TRIAL PROGRAMS).
P100025|S001|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATH TEK UBTFOR H. PYLORI KIT|OZA|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2012|09/05/2012|||APPR|APPROVAL FOR PACKAGING CHANGES FOR THE BREATHTEK UBT FOR H.  PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0. THE PACKAGING CHANGES CONSIST OF NEW KIT AND SHIPPER CARTONS ALONG WITH NEW LABELING ON THE EACH OF THESE CARTONS.
P000036|S010|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2012|04/13/2012|||OK30|CHANGE IN THE MEDIA BAG SIZE.
P100023|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice||N|03/20/2012|08/16/2012|||APPR|APPROVAL FOR HARDWARE AND SOFTWARE CHANGES TO THE CATHETER PORT MANUFACTURING PROCESS.
P110010|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice||N|03/20/2012|08/16/2012|||APPR|APPROVAL FOR HARDWARE AND SOFTWARE CHANGES TO THE CATHETER PORT MANUFACTURING PROCESS.
P000021|S023|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|03/20/2012|02/22/2013|||APPR|APPROVAL FOR A SOFTWARE REVISION THAT CHANGES THE OPERATING SYSTEM OF THE INSTRUMENT FROM THE CURRENT QNX OPERATING SYSTEM TO THE LINUX OPERATING SYSTEM AND ADDRESSES HARDWARE OBSOLESCENCE ISSUES.
P060022|S013|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/20/2012|05/16/2012|||APPR|APPROVAL TO ADD TWO TABS TO THE HAPTICS OF THE MODEL M160 IOL.
P860057|S087|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice||N|03/19/2012|04/13/2012|||OK30|NEW SUPPLIER FOR SELVEDGE YARN.
P870056|S048|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS® PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice||N|03/20/2012|04/13/2012|||OK30|NEW SUPPLIER FOR SELVEDGE YARN.
P870077|S043|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS® DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHES|DYE|CV|30-Day Notice||N|03/20/2012|04/13/2012|||OK30|NEW SUPPLIER FOR SELVEDGE YARN.
P000007|S030|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice||N|03/20/2012|04/13/2012|||OK30|NEW SUPPLIER FOR SELVEDGE YARN.
P010041|S032|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS® SUPRAANNULAR (S.A.V.) BIOPROSTHESIS|DYE|CV|30-Day Notice||N|03/20/2012|04/13/2012|||OK30|NEW SUPPLIER FOR SELVEDGE YARN.
P000037|S025|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2012|06/08/2012|||APPR|APPROVAL TO MOVE THE MACHINING PROCESS FOR SIZE 25 VALVE HOUSING SUBSTRATES IN-HOUSE.
P040012|S044|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CARTOID STENT SYSTEM|NIM|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/20/2012|08/24/2012|||APPR|APPROVAL TO UPDATE THE LABELING WITH LONG TERM CREST STUDY RESULTS.
P090028|S002|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|04/16/2012|||OK30|CHANGE IN THE TIMING OF THE QA RELEASE TESTS FROM SEQUENTIAL TO CONCURRENT.
P100001|S001|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|04/16/2012|||OK30|CHANGE IN THE TIMING OF THE QA RELEASE TESTS FROM SEQUENTIAL TO CONCURRENT.
P100021|S014|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEMS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|04/23/2012|||OK30|AUTOMATION OF THE ETCHING AND HEAT SETTING PROCESSES AND A CHANGE IN SOLUTION MIXING LOCATION AT A COMPONENT SUPPLIER.
P080023|S014|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|04/13/2012|||OK30|TEST METHOD CHANGE FOR BIOBURDEN EVALUATION OF AN INTERMEDIATE USED IN THE MANUFACTURE OF ARCHITECT CORE CALIBRATOR AND CONTROLS.
P030009|S061|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER AND MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P060033|S070|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P110013|S001|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY & MICROTRAC ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P990020|S047|Medtronic Vascular|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ANEURX AAAADVANTAGE STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice||N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P070027|S034|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVER SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P070007|S035|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM WITH THE XCELERANT AND CAPTIVA DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P100021|S015|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P100040|S007|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVA DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P110011|S002|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P090006|S008|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|08/16/2012|||APPR|APPROVAL FOR A CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM.
P100029|S011|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|Special (Immediate Track)||N|03/22/2012|04/13/2012|||APPR|APPROVAL FOR REVISING THE INSTRUCTION REGARDING ¿SUTURE TAILS¿.
P040021|S021|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR & BIOCOR SUPRA VALVES, EPIC & EPIC SUPRA VALVES|LWR|CV|Special (Immediate Track)||N|03/22/2012|04/13/2012|||APPR|APPROVAL FOR REVISING THE INSTRUCTION REGARDING SUTURE TAILS.
P840001|S206|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|04/20/2012|||OK30|REDUCE THE SAMPLE SIZE FOR PARALLEL GAP WELD LINE TESTING ON PLATED COMPONENTS.
P960009|S138|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|04/20/2012|||OK30|REDUCE THE SAMPLE SIZE FOR PARALLEL GAP WELD LINE TESTING ON PLATED COMPONENTS.
P970004|S131|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|04/20/2012|||OK30|REDUCE THE SAMPLE SIZE FOR PARALLEL GAP WELD LINE TESTING ON PLATED COMPONENTS.
P080025|S028|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2012|04/20/2012|||OK30|REDUCE THE SAMPLE SIZE FOR PARALLEL GAP WELD LINE TESTING ON PLATED COMPONENTS.
P100014|S005|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/20/2012|04/24/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010047|S018|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/20/2012|||OK30|IMPLEMENT AN AUTOMATED OPTICAL INSPECTION SYSTEM IN ADDITION TO A CURRENT MANUAL INSPECTION.
P100014|S006|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|05/04/2012|||OK30|ADDITIONAL LABORATORY FOR ANALYTICAL TESTING
P000029|S071|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|ADDITIONAL LABORATORY FOR ANALYTICAL TESTING.
P990046|S028|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|06/28/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN MINNEAPOLIS, MINNESOTA.
P900056|S113|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH WIRECLIP TORQUER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P920047|S051|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P980003|S035|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED  ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P020009|S082|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P020025|S033|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P030025|S095|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P040016|S085|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P060006|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P060008|S086|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELYTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P100023|S039|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P110010|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT.
P950029|S067|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR/DR, ESPRIT SR/DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS.
P980049|S072|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS.
P060027|S039|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2012|04/19/2012|||OK30|ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS.
P980022|S116|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2012|05/24/2012|||APPR|APPROVAL OF A CHANGE OF THE FIELD EFFECT TRANSISTOR (FET), A COMPONENTOF THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K), THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-722, MMT-522K, MMT-722K), AND THE GUARDIAN REAL-TIME MONITOR (MODELS CSS7100 AND CSS7100K), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND GUARDIAN REAL-TIME SYSTEMS.
P110010|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/13/2012|||OK30|IMPLEMENTATION OF A NEW LASER SYSTEM FOR SORTING EXTRUDED BALLOON TUBES.
P000006|S028|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/19/2012|||OK30|CHANGE IN THE STERILIZATION LOAD CONFIGURATION FOR THE SURGICAL PRODUCTS.
P050039|S008|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|08/17/2012|||APPR|APPROVAL FOR REQUESTED CHANGES TO THE BLEND/POLISH WORK INSTRUCTION FOR THE NOVACTION SPLINED STEMS.
P900061|S113|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2012|07/18/2012|||APPR|APPROVAL CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURING OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER.
P920015|S090|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE SVC LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2012|07/18/2012|||APPR|APPROVAL TO CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURING OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER.
P980050|S072|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2012|07/18/2012|||APPR|APPROVAL TO CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURING OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER.
P840001|S207|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/25/2012|||OK30|ELIMINATION OF THE PARALLEL GAP WELDING LINE TESTING WITH GOLD PLATING OVER BASE NICKEL COMPONENTS.
P960009|S139|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/25/2012|||OK30|ELIMINATION OF THE PARALLEL GAP WELDING LINE TESTING WITH GOLD PLATING OVER BASE NICKEL COMPONENTS.
P970004|S132|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/25/2012|||OK30|ELIMINATION OF THE PARALLEL GAP WELDING LINE TESTING WITH GOLD PLATING OVER BASE NICKEL COMPONENTS.
P080025|S029|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/25/2012|||OK30|ELIMINATION OF THE PARALLEL GAP WELDING LINE TESTING WITH GOLD PLATING OVER BASE NICKEL COMPONENTS.
P030029|S013|SIEMENS HEALTHCARE DIAGNOSTICS|333 Coney Street||Walpole|MA|02032||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS ASSAY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|10/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
P030040|S008|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC IGM ASSAY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|10/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
P030049|S010|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|10/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
P030056|S007|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR HCV ASSAY|MZO|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|10/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
P040004|S009|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL ASSAY|LOM|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|10/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
P010012|S286|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNTUA CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P030005|S082|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM FAMILY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P050046|S014|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE LEAD SYSTEM FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P800019|S013|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CYBERLITH|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P820022|S005|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|CYBERTACH PULSE GENERATOR SYSTEM|LWW|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P830026|S080|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P830060|S070|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P840068|S050|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA/VISTA FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P860007|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||PULSE-GENERATOR, SINGLE CHAMBER, SINGLE|INTERTACH|LWW|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P890061|S020|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P910020|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112|||RELAY||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P910073|S101|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD SYSTEM FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P910077|S120|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERSTER DEFIBRILLATOR (AICD) FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P930035|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P940008|S029|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q / RES-Q MICRON PULSE GENERATOR SYSTEM FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P940031|S072|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P950001|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE LEAD SYSTEM FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P960004|S051|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P960006|S033|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEM FAMILIES|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P960040|S256|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNTUA IDCS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|04/23/2012|||OK30|IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
P900060|S049|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VLAVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|09/10/2012|||APPR|APPROVAL TO ADD NEW EQUIPMENT TO THE PYROLYTIC CARBON COATING PROCESS.
P010032|S049|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|IMPLANTABLE PULSE GENERATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|04/25/2012|||OK30|STERILIZATION MANUFACTURING PROCESS CHANGES FOR ST. JUDE MEDICAL NEUROMODULATION DIVISION PRODUCTS.
P110019|S017|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|04/27/2012|||OK30|CHANGE TO THE DISLODGMENT TESTING SAMPLING PLAN.
P840001|S208|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC RESTORESENSOR NEUROSTIMULATOR|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/27/2012|05/24/2012|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE L283 MULTI- FUNCTION INTEGRATED CIRCUIT CONTAINED IN THE NEUROSTIMULATOR OF THE RESTORESENSOR NEUROSTIMULATOR, MODEL 37714.
P970029|S019|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|TMR2000 HOLMIUM LASER SYSTEM|MNO|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/27/2012|05/25/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980035|S267|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|REVO MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|04/25/2012|||OK30|MODIFY THE ELECTRONICALLY ERASABLE PROGRAMMABLE READ-ONLY MEMORY (EEPROM) STATUS BYTE TEST REQUIREMENT.
P090013|S060|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ENRHYTHM IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|04/25/2012|||OK30|MODIFY THE ELECTRONICALLY ERASABLE PROGRAMMABLE READ-ONLY MEMORY (EEPROM) STATUS BYTE TEST REQUIREMENT.
P930036|S005|SIEMENS HEALTHCARE DIAGNOSTICS INC.|333 CONEY  STREET||EAST WALPOLE|MA|02032||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ADVIA CENTAUR AFP ASSAY|LOK|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|10/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
P950021|S013|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ADVIA CENTAUR PSA ASSAY|MTF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|10/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
P990055|S014|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ADVIA CENTAUR CPSA ASSAY|NAF|IM|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2012|10/15/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
P100029|S012|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|04/26/2012|||OK30|CHANGE TO THE MANUFACTURING SOLUTIONS USED DURING TISSUE PROCESSING.
P070026|S005|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|04/26/2012|||OK30|CHANGES TO THE STERILE BARRIER PACKAGE SEALING PROCESS USED FOR THE CERAMIC FEMORAL HEADS AND ACETABULAR LINERS.
P090002|S003|DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|04/26/2012|||OK30|CHANGES TO THE STERILE BARRIER PACKAGE SEALING PROCESS USED FOR THE CERAMIC FEMORAL HEADS AND ACETABULAR LINERS.
P040023|S020|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2012|04/26/2012|||OK30|CHANGES TO THE STERILE BARRIER PACKAGE SEALING PROCESS USED FOR THE CERAMIC FEMORAL HEADS AND ACETABULAR LINERS.
P010031|S298|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA II CRT-D, CONSULTA, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA, PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2012|04/23/2012|||OK30|CHANGE TO THE HYBRID BURN-IN TIME.
P980016|S346|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II, MAXIMO II ICD, PROTECTA, PROTECTA ICD, PROTECTA XT, PROTECTA XT ICD, SECURA, SECURA ICD,VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2012|04/23/2012|||OK30|CHANGE TO THE HYBRID BURN-IN TIME.
P050039|S009|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/28/2012|04/26/2012|||APPR|APPROVAL FOR CHANGES TO THE NOVATION® AHS INSTRUCTIONS FOR USE TO REORGANIZE INFORMATION FOR CLARITY, REMOVE INFORMATION THAT IS REDUNDANT, AND ENSURE CONSISTENCY.
P950009|S015|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT SLIDE PROFILER|MNM|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/28/2012|09/13/2013|||APPR|APPROVAL FOR THE BD FOCALPOINT SLIDE PROFILER WITH THE NEW DIGITAL PRIMARYCAMERA.
P050028|S024|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0|MKT|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2012|06/07/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., IN SOMERVILLE, NEW JERSEY.
P060030|S025|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2012|06/07/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., IN SOMERVILLE, NEW JERSEY.
P000012|S038|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBAS AMPLICOR HCV TEST, V2.0|MZP|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2012|06/07/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., IN SOMERVILLE, NEW JERSEY.
P100020|S003|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2012|06/07/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., IN SOMERVILLE, NEW JERSEY.
P110016|S001|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR|OAD|CV|135 Review Track For 30-Day Notice||N|03/29/2012|09/13/2012|||APPR|APPROVAL FOR AN ALTERNATE VENDOR TO SUPPLY PRINTED CIRCUIT BOARDS FOR THE 1500T9-CP V1.6 GENERATOR.
P050047|S024|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2012|04/16/2012|||OK30|REVIEW TO INCREASE THE NUMBER OF SYRINGES DRIED IN THE DRYING OVENS AND HARMONIZE THE NUMBER OF SYRINGES DRIED PER DRYING CYCLE WITH THE NUMBER OF SYRINGES STERILIZED PER STERILIZATION CYCLE.
P000029|S072|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2012|04/12/2012|||OK30|ADDITION OF THE POSSIBILITY TO STORE SAMPLES FOR BIOBURDEN ANALYSIS IN A REFRIGERATOR AT A TEMPERATURE OF 5 DEGREE CELSIUS FOR UP TO 18 HOURS BEFORE ANALYSIS.
P010020|S022|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2012|04/26/2012|||OK30|IMPLEMENTATION OF ADDITIONAL MOLD PRESS EQUIPMENT AND CHANGE IN QUALIFIED SUPPLIER FOR A SPRING COMPONENT.
P020004|S071|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2012|04/27/2012|||OK30|EXPANSION OF THE OPERATING PARAMETERS FOR AN AUTOMATED FILM WRAPPING MACHINE.
P070004|S001|SIENTRA, INC|6769 HOLLISTER AVENUE|SUITE 201|SANTA BARBARA|CA|93117||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SIENTRA SILICONE GEL BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/30/2012|05/29/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P070004|S002|SIENTRA, INC|6769 HOLLISTER AVENUE|SUITE 201|SANTA BARBARA|CA|93117||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SIENTRA SILICONE GEL BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/30/2012|05/29/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P070004|S003|SIENTRA, INC|6769 HOLLISTER AVENUE|SUITE 201|SANTA BARBARA|CA|93117||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SIENTRA SILICONE GEL BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/30/2012|05/29/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100014|S007|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|30-Day Notice||N|03/30/2012|04/12/2012|||OK30|ADDITION OF THE POSSIBILITY TO STORE SAMPLES FOR BIOBURDEN ANALYSIS IN A REFRIGERATOR AT A TEMPERATURE OF 5 DEGREE CELSIUS FOR UP TO 18 HOURS BEFORE ANALYSIS.
P080011|S011|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2012|05/11/2012|||OK30|REVALIDATION OF BIOFINITY MANUFACTURING LINE #4 WITH THE FOLLOWING MANUFACTURING CHANGES:  1) AN INCREASE IN TEMPERATURE OF THE BARREL HEATER ON THE INJECTION MOLDING MACHINE; AND 2) A CONSOLIDATION CHANGE IN THE DESIGN OF THE FILL AND CLOSE MODULE.
P810031|S044|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2012|04/18/2012|||OK30|CHANGE TO REPLACE REUSABLE GLASS SAMPLE TUBES WITH DISPOSABLE POLYPROPYLENE SAMPLE TUBES IN THE SODIUM HYALURONATE TEST METHOD.
P010012|S287|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNTUA CRT-D , COGNIS, ENERGEN & INCEPTA CRT-D|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2012|05/03/2012|||APPR|APPROVAL FOR THE LABELING MODIFICATION OF THE DEVICE LONGEVITY TABLES FOR THE DEVICES.
P960040|S257|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNTUA ICD, TELIGEN, ENERGEN ICD & INCEPTA ICD|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/30/2012|05/03/2012|||APPR|APPROVAL FOR THE LABELING MODIFICATION OF THE DEVICE LONGEVITY TABLES FOR THE DEVICES.
P000053|S042|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|05/02/2012|||OK30|CHANGE IN A MEASUREMENT METHOD USED DURING POST STERILE PACKAGING OPERATION.
P010020|S023|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|05/02/2012|||OK30|CHANGE IN A MEASUREMENT METHOD USED DURING POST STERILE PACKAGING OPERATION.
P060002|S025|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|04/27/2012|||OK30|UPDATES TO EXISTING RAW MATERIAL INSPECTION EQUIPMENT AND THE ADDITION OF NEW RAW MATERIAL INSPECTION EQUIPMENT.
P080007|S013|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|04/27/2012|||OK30|UPDATES TO EXISTING RAW MATERIAL INSPECTION EQUIPMENT AND THE ADDITION OF NEW RAW MATERIAL INSPECTION EQUIPMENT.
P070014|S031|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|04/27/2012|||OK30|UPDATES TO EXISTING RAW MATERIAL INSPECTION EQUIPMENT AND THE ADDITION OF NEW RAW MATERIAL INSPECTION EQUIPMENT.
P100017|S002|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|09/27/2012|||APPR|APPROVAL FOR A CHANGE FROM A MANUAL ASSEMBLY SYSTEM TO AN AUTOMATED PROCESS FOR KIT PACKAGING.
P950037|S107|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS, CYLOS, EVIA, ESTELLA, EFFECTA FAMILY IMPLANTABLE PULSE GENERATORS|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|12/03/2012|||APPR|APPROVAL FOR AN UPDATE TO PARAMETERS USED IN LASER WELDING PROCESSES.
P070008|S032|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV & STRATOS LV-T|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|12/03/2012|||APPR|APPROVAL FOR AN UPDATE TO PARAMETERS USED IN LASER WELDING PROCESSES.
P100020|S004|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|ROCHE COBAS HPV TEST|MAQ|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2012|06/25/2013|||APPR|APPROVAL FOR PROCESSING OF RESIDUAL CERVICAL SAMPLE DIRECTLY FROM THE PRESERVCYT¿ VIAL (HOLOGIC, INC., BEDFORD, MA) AFTER PROCESSING FOR LIQUID-BASED CYTOLOGY (LBC) USING EITHER THE HOLOGIC THINPREP® 2000 OR THINPREP® 3000 PROCESSORS AND TESTING ON THE COBAS® 4800 SYSTEM DIRECTLY FROM THE PRESERVCYT VIAL (PRIMARY VIAL). APPROVAL FOR CAPABILITY TOADD OPTIONAL NON-IVD SOFTWARE TO THE COBAS® 4800 SYSTEM THAT IS USED TO PERFORM THE COBAS® HPV TEST WAS ALSO REQUESTED.
P840001|S209|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 3587A RESUME II AND 3986A RESUME TL LEADS|LGW|NE|30-Day Notice||N|04/02/2012|05/02/2012|||OK30|CHANGE IN THE ACCEPTANCE CRITERIA OF THE INSULATED CABLE AND THE QUALIFICATION OF A NEW  SUPPLIER.
P960009|S141|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC MODEL 37603 IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR REWORK|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|05/02/2012|||OK30|CHANGE THE CONNECTOR REWORK PROCESS.
P910001|S054|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|05/02/2012|||OK30|MODIFICATION TO THE ETHYLENE OXIDE STERILIZATION CYCLE.
P960042|S035|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|05/02/2012|||OK30|MODIFICATION TO THE ETHYLENE OXIDE STERILIZATION CYCLE.
P080026|S003|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV ASSAY|MKT|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|09/26/2012|||APPR|APPROVAL FOR A CHANGE FROM A MANUAL ASSEMBLY SYSTEM TO AN AUTOMATED PROCESS FOR KIT PACKAGING.
P960043|S078|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice||N|04/03/2012|04/27/2012|||OK30|ADD AN ALTERNATE SUPPLIER FOR DETACHABLE NEEDLES.
P100021|S016|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2012|05/03/2012|||OK30|SUPPLIER PROCESS TRANSFER FOR STENT AND STENT RING COMPONENTS.
P980040|S039|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, INTRAOCULAR, TORIC OPTICS|TECNIS TORIC 1-PEICE INTRAOCULAR LENS|MJP|OP|Panel Track|Change Design/Components/Specifications/Material|N|04/09/2012|04/15/2013|13M-0463|04/24/2013|APPR|APPROVAL OF THE TECNJS® TORIC 1-PIECE IOL, MODELS ZCT150, ZCT225, ZCT300 AND ZCT400, AND THE TECNIS® TORIC CALCULATOR SYSTEM. THIS DEVICE IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM OF ONE DIOPTER OR GREATER IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION IN RESIDUAL REFRACTIVE CYLINDER AND INCREASEDSPECTACLE INDEPENDENCE FOR DISTANCE VISION. THE DEVICE IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P960043|S079|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM|MGB|CV|30-Day Notice||N|04/04/2012|05/03/2012|||OK30|ALTERNATE SUPPLIER FOR THE COILED SUTURE TUBE.
P960009|S142|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|37751 RECHARGE CHARGING SYSTEM|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/04/2012|04/20/2012|||APPR|APPROVAL FOR LABELING CHANGES TO THE MANUALS FOR THE MODEL 37751 RECHARGE CHARGER SYSTEM, THE INFORMATION FOR PRESCRIBERS MANUAL - MEDTRONIC DBS THERAPY, AND THE INFORMATION FOR PRESCRIBERS MANUAL- MEDTRONIC PAIN THERAPY USING NEUROSTIMULATION FOR CHRONIC PAIN. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO RECHARGER USE, MODIFICATION OF THE DEVICE, AND THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION.
P840001|S210|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|37751 RECHARGE CHARGING SYSTEM|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/04/2012|04/20/2012|||APPR|APPROVAL FOR LABELING CHANGES TO THE MANUALS FOR THE MODEL 37751 RECHARGE CHARGER SYSTEM, THE INFORMATION FOR PRESCRIBERS MANUAL - MEDTRONIC DBS THERAPY, AND THE INFORMATION FOR PRESCRIBERS MANUAL- MEDTRONIC PAIN THERAPY USING NEUROSTIMULATION FOR CHRONIC PAIN. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO RECHARGER USE, MODIFICATION OF THE DEVICE, AND THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION.
P980044|S013|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice||N|04/04/2012|05/04/2012|||OK30|REPLACEMENT OF CONTROLLER COMPONENTS.
P080020|S001|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2012|05/04/2012|||OK30|REPLACEMENT OF CONTROLLER COMPONENTS.
P880086|S218|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|PACEMAKER FAMILY OF DEVICES (INTEGRITY, IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES)|NVZ|CV|30-Day Notice||N|04/03/2012|05/03/2012|||OK30|IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
P030035|S096|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT-P FAMILY OF DEVICES (FRONTIER, FRONTIER II, ANTHEM FAMILY OF DEVICES)|NIK|CV|30-Day Notice||N|04/03/2012|05/03/2012|||OK30|IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
P880006|S079|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|REGENCY FAMILY OF DEVICES|NIK|CV|30-Day Notice||N|04/03/2012|05/03/2012|||OK30|IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
P970013|S048|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF DEVICES|NIK|CV|30-Day Notice||N|04/03/2012|05/03/2012|||OK30|IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
P910023|S294|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES|NVZ|CV|30-Day Notice||N|04/03/2012|05/03/2012|||OK30|IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
P030054|S221|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT-D FAMILY OF DEVICES & UNIFY QUADRA FAMILY OF DEVICES|NIK|CV|30-Day Notice||N|04/03/2012|05/03/2012|||OK30|IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
P960013|S072|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL (TENDRIL, TENDRIL ST, TENDRIL STS) AND OPTISENSE FAMILY OF LEADS|NVN|CV|30-Day Notice||N|04/03/2012|05/03/2012|||OK30|IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
P960030|S036|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|ISOFLEX (ISOFLEX S, ISOFLEX P, ISOFLEX OPTIM) AND PASSIVE PLUS FAMILY OF LEADS|NVY|CV|30-Day Notice||N|04/03/2012|05/03/2012|||OK30|IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.
P010015|S159|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P & SYNCRA CRT-P|OJX|CV|30-Day Notice||N|04/03/2012|05/02/2012|||OK30|CHANGE IN THE FINAL VISUAL INSPECTION PROCESS.
P890003|S249|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ELITE, ELITE II, MINUET, PREVA, PRODIGY, SYNERGYST II, THERA, VITATRON & REVEAL|NVZ|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P820003|S116|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PASYS, PASUS ST, SPECTRAX, SYMBIOS AND SYMBIOS FAMILIES|LWP|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P850051|S079|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse-generator, single chamber, sensor driven, implantable|ACTIVITRAX, LEGEND, LEGEND II, MINIX, PEMIER, PREVAIL, VITATRON|LWO|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P900061|S114|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD|LWS|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TO MEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P930022|S014|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|LEGEND PLUS|NVZ|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P970012|S091|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|KAPPA 400|NVZ|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980016|S347|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST|LWS|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980035|S268|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA|NVZ|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980050|S073|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DIVA FAMILY, SELECTION AFM C-SERIES AND T-SERIES DEVICES|LWS|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P990001|S104|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON IPGS|NVZ|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P010015|S160|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA, INSYNC, INSYNC III, SYNCRA|OJX|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P010031|S299|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO, CONCERTO II, INSYNC ICD, INSYNC II MARQUIS, INSYNC SENTRY, MAXIMO II, PROTECTA|NIK|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P090013|S061|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process||N|04/04/2012|04/25/2012|||APPR|APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
P980022|S117|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTIUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2012|05/17/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE CARELINK PERSONAL THERAPY MANAGEMENT SYSTEM FOR DIABETES MMT-7333, V5.8A FOR USE WITH THE DEVICE.
P100029|S013|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2012|06/29/2012|||APPR|APPROVAL FOR A CHANGE TO THE TRIFECTA VALVE STENT SPECIFICATION TO REQUIRE 100%  INSPECTION FOR WALL THICKNESS AT A NEW, SINGLE LOCATION - STENT RAIL.
P030025|S096|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|04/05/2012|05/04/2012|||OK30|ADDITIONAL DRYING CYCLE FOR THE COATING COMPONENT OF THE DEVICE.
P060008|S087|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|04/05/2012|05/04/2012|||OK30|ADDITIONAL DRYING CYCLE FOR THE COATING COMPONENT OF THE DEVICE.
P100023|S041|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|04/05/2012|05/04/2012|||OK30|ADDITIONAL DRYING CYCLE FOR THE COATING COMPONENT OF THE DEVICE.
P950037|S108|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/05/2012|05/17/2012|||APPR|APPROVAL TO ADD A COPPER ALLOY SHIELDING PLATE TO BE APPLIED OVER THE HOUSING OF A QUARTZ CRYSTAL ON THE PCB AND UPDATE THE DEVICE LABELING.  THE PURPOSE FOR THESE MODIFICATIONS IS TO IMPROVE PERFORMANCE DURING RF CAUTERY.
P010029|S015|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice||N|04/05/2012|05/04/2012|||OK30|ADDITION OF A NEW FILLING MACHINE.
P020011|S005|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA QUALITATIVE ASSAY|MZP|MI|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/05/2012|06/25/2012|||APPR|APPROVAL FOR A DEVICE NAME CHANGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERSANT HCV RNA QUALITATIVE ASSAY AND APTIMA HCV RNA QUALITATIVE ASSAY AND IS INDICATED FOR THE DETECTION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA (EDTA, SODIUM HEPARIN, SODIUM CITRATE, AND ACD) OR SERUM.
P960042|S036|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/05/2012|05/24/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE FISH TAPE ACCESSORY OF THE DEVICE.
P000037|S026|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice||N|04/05/2012|05/03/2012|||OK30|AUTOMATION OF THE VACUUM CLEANING PROCESS.
P080032|S009|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/14/2012|06/26/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000025|S062|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/05/2012|10/26/2012|||APPR|APPROVAL FOR THE RONDO AUDIO PROCESSOR.
P840001|S211|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/05/2012|05/30/2012|||APPR|APPROVAL FOR ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704.  THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704 AND ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OFTHE TRUNK AND/OR LIMBS-INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING CONDITIONS:  1) FAILED BACK SYNDROME (FBS) OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FBS OR HERNIATED DISK; 3)  POSTLAMINECTOMY PAIN; 4) MULTIPLE BACK OPERATIONS;5) UNSUCCESSFUL DISK SURGERY; 6)  DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS;7) PERIPHERAL CAUSALGIA; 8) EPIDURAL FIBROSIS; 9) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 10) COMPLEX REGIONAL PAIN SYNDROME (CRPS);11) REFLEX SYMPATHETIC DYSTROPHY (RSD), OR 11) CAUSALGIA.
P070014|S032|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT SOLO VASCULAR STENT SYSTEM|NIP|CV|Real-Time Process||N|04/06/2012|05/25/2012|||APPR|APPROVAL FOR MINOR CHANGES TO THE DIVING SHEATH WITH PULL WIRE COMPONENT OF THE DELIVERY SYSTEM.
P010047|S019|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT DEVICE|NBE|AN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/06/2012|08/23/2012|||APPR|APPROVAL FOR AN EXTENSION OF THE REFRIGERATED SHELF LIFE OF THE DEVICE.
P980016|S348|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, MXIMO II M4, PROTECTA CRT-D, PROTECTA M4, XT CRT-D & XT M4|LWS|CV|30-Day Notice||N|04/06/2012|05/04/2012|||OK30|SOFTWARE UPGRADE TO AN EXISTING TEST EQUIPMENT.
P010031|S300|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||MAXIMO II ICD, MAXIMO II M4, PROTECTA ICD, PROTECTA M4, XT ICD, PROTECTA XT M4, SECURA ICD, SECURA M4, VIRTUOSO II DR/VR||CV|30-Day Notice||N|04/06/2012|05/04/2012|||OK30|SOFTWARE UPGRADE TO AN EXISTING TEST EQUIPMENT.
P040048|S017|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRILOGY AB ACETABULAR SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2012|10/25/2012|||APPR|APPROVAL FOR THE ADDITION OF A NEW CLEANROOM.
P060037|S017|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS/LPS FLEX MOBILE KNEE|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2012|10/25/2012|||APPR|APPROVAL FOR THE ADDITION OF A NEW CLEANROOM.
P040003|S011|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE DEVICE|NRZ|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/09/2012|05/01/2012|||APPR|APPROVAL FOR LABELING CHANGES INCLUDING: 1) DELETION OF THE COMMENT (OUTCOMES OF 10 PREGNANCIES ARE PENDING AS OF AUGUST 2008, AND OUTCOME OF ONE PREGNANCY IS UNKNOWN.) AND ADDITION OF DEEP VEIN THROMBOSIS UNDER THE SECTION ENTITLED OTHER ADVERSE EVENTS.
P070004|S004|SIENTRA, INC|6769 HOLLISTER AVENUE|SUITE 201|SANTA BARBARA|CA|93117||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SIENTRA SILICONE GEL BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/09/2012|06/07/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110013|S002|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2012|12/21/2012|||APPR|APPROVAL FOR THE INTRODUCTION OF A STENT ALIGNMENT MANUFACTURING PROCESS AND A MARKER BAND SPACING SPECIFICATION CHANGE.
P030011|S012|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2012|06/26/2012|||APPR|APPROVAL FOR RELOCATION OF A POLYMER MANUFACTURING PROCESS.
P840001|S212|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION (SCS) INPLANTABLE NEUROSTIMULATORS (INS) RESTORE FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2012|05/10/2012|||OK30|CHANGES IN THE MANUFACTURING PROCESS AT MEDTRONIC¿S SUPPLIER OF GROMMETS USED IN VARIOUS MEDTRONIC NEUROMODULATION IMPLANTABLE DEVICES.
P960009|S143|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION (DBS) INS ACTIVA FAMILY, DBS ACCESSORIES, DBS INS SOLETRA FAMILY & DBS INS KINETRA FAMILY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2012|05/10/2012|||OK30|CHANGES IN THE MANUFACTURING PROCESS AT MEDTRONIC¿S SUPPLIER OF GROMMETS USED IN VARIOUS MEDTRONIC NEUROMODULATION IMPLANTABLE DEVICES.
P970004|S133|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY INS INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2012|05/10/2012|||OK30|CHANGES IN THE MANUFACTURING PROCESS AT MEDTRONIC¿S SUPPLIER OF GROMMETS USED IN VARIOUS MEDTRONIC NEUROMODULATION IMPLANTABLE DEVICES.
P080025|S030|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL INS INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2012|05/10/2012|||OK30|CHANGES IN THE MANUFACTURING PROCESS AT MEDTRONIC¿S SUPPLIER OF GROMMETS USED IN VARIOUS MEDTRONIC NEUROMODULATION IMPLANTABLE DEVICES.
P960042|S037|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2012|05/16/2012|||APPR|APPROVAL FOR QUALIFYING THE USE OF LOCTITE 7701 AS A SUITABLE REPLACEMENT FOR THE DISCONTINUED LOCTITE 793.
P850079|S052|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|COOPERVISION METHAFILCON A & B SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2012|06/28/2012|||OK30|CHANGE IN THE SUPPLIER¿S METHOD OF MANUFACTURING A RAW MATERIAL USED TO PRODUCE CONTACT LENSES.
P980016|S349|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2012|05/10/2012|||OK30|UPDATE TO THE VENDOR INSPECTION PROCESS FOR FLEX COMPONENT.
P010031|S301|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2012|05/10/2012|||OK30|UPDATE TO THE VENDOR INSPECTION PROCESS FOR FLEX COMPONENT.
P960058|S096|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HARMONY HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2012|08/20/2012|||APPR|APPROVAL FOR THE CHANGE IN FABRICATION LINE FOR THE ANALOG INTEGRATED CIRCUIT (AIC).
N18033|S065|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2012|05/09/2012|||OK30|CHANGE TO A NEW SUPPLIER OF THE CURE LAMPS USED DURING MANUFACTURING.
P030017|S132|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2012|05/10/2012|||OK30|USE AN ALTERNATIVE OVEN DURING THE MANUFACTURE OF W4 AND D4 2X4 SPLITTERS FOR THE DEVICE.
P060038|S012|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)|LWR|CV|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|04/12/2012|10/09/2012|||APPR|APPROVAL FOR THE DEVICE.
P010019|S030|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2012|05/16/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A CHEMICAL COMPONENT OF THE FINISHED DEVICE.
P020014|S038|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|CONCEPTUS ESSURE SYSTEM|HHS|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2012|10/02/2012|||APPR|APPROVAL FOR A MATERIAL CHANGE AND A MINOR PROCESS CHANGE.  THE USE OF NEW CARBOTHANE MATERIALS IN THE DELIVERY CATHETER WITH THE NEW HYDROPHILIC COATING AND A CHANGE IN OPERATING TEMPERATURE.
P000053|S043|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2012|05/09/2012|||OK30|ALTERNATE MOLD FOR THE BALLOON ADAPTER.
P040021|S022|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/17/2012|08/30/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S088|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2900, 3000TFX, 3300TFX|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2012|05/15/2012|||OK30|ADDITIONAL STERILIZATION AND BIOBURDEN REDUCTION PROCESS EQUIPMENT.
P080014|S012|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2012|05/21/2012|||APPR|APPROVAL FOR A SOFTWARE REVISION CHANGE FROM CERVISTA HPV HR V5.4 TO CERVISTA HPV HR V6.0.
P080015|S007|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2012|05/21/2012|||APPR|APPROVAL FOR A SOFTWARE REVISION CHANGE FROM CERVISTA HPV 16/18 V5.4 TO CERVISTA HPV 16/18 V6.0.
P060040|S017|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II VENTRICULAR ASSISTE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2012|05/17/2012|||OK30|CHANGE TO THE CORED SOLDER WIRE FORMULATION.
P040023|S021|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/18/2012|06/15/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P990071|S017|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|STOCKERT 70 RADIOFREQUENCY GENERATOR|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2012|03/07/2013|||APPR|APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.
P950005|S037|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2012|03/07/2013|||APPR|APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.
P990025|S031|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2012|03/07/2013|||APPR|APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.
P010068|S027|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR® AND CELSIUS® DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2012|03/07/2013|||APPR|APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.
P030031|S041|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER AND CELSIUS® THERMOCOOL® DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2012|03/07/2013|||APPR|APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.
P040036|S030|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR®THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2012|03/07/2013|||APPR|APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.
P930031|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2012|06/06/2012|||OK30|REMOVAL OF TWO IN-PROCESS CLEANING STEPS.
P980033|S020|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2012|06/06/2012|||OK30|REMOVAL OF TWO IN-PROCESS CLEANING STEPS.
P020009|S083|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS AND EXPRESS2 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2012|05/09/2012|||OK30|REMOVAL OF A PACKAGING CHECK WEIGHING STEP.
P040016|S086|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2012|05/09/2012|||OK30|REMOVAL OF A PACKAGING CHECK WEIGHING STEP.
P060006|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2012|05/09/2012|||OK30|REMOVAL OF A PACKAGING CHECK WEIGHING STEP.
P010032|S050|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2012|06/26/2013|||APPR|APPROVAL FOR THE ADDITION OF SEVERAL PIECES OF EQUIPMENT THAT ARE NEW TO THE MANUFACTURING PROCESS AS WELL AS THE RELOCATION OF EQUIPMENT AND THE ADDITION OF AN ALREADY APPROVED PIECE OF EQUIPMENT TO THE BILBY ROAD FACILITY LOCATION.
P010032|S051|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2012|05/17/2012|||OK30|WELDING PROCESS CHANGE FOR THE DEVICE.
P090003|S012|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2012|05/09/2012|||OK30|ADDITION OF AN IN-PROCESS INSPECTION FOR BALLOON MANUFACTURING.
P020004|S072|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2012|11/07/2012|||APPR|APPROVAL FOR USE OF AN ALTERNATE PTFE RESIN.
P040043|S047|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2012|11/07/2012|||APPR|APPROVAL FOR USE OF AN ALTERNATE PTFE RESIN.
P090022|S012|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/2012|01/29/2013|||APPR|APPROVAL FOR THE PRELOADED INJECTOR (PLI) INTRAOCULAR LENS (IOL) DELIVERY SYSTEM.
P060040|S018|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEART MATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/2012|06/22/2012|||APPR|APPROVAL FOR THE SEALED OUTFLOW GRAFT BEND RELIEF COLLAR (SOBR COLLAR).
P080012|S004|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/2012|02/13/2013|||APPR|APPROVAL FOR A MODIFICATION TO THE LABELING CLAIM FROM "MR UNSAFE"TO "MR CONDITIONAL" USE.
P090013|S063|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG, ENRHYTHM MRI IPG|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/2012|02/19/2013|||APPR|APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.
P010015|S162|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/2012|02/19/2013|||APPR|APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.
P980035|S270|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ENRHYTHM IPG|NVZ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/2012|02/19/2013|||APPR|APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.
P980040|S040|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS SOFT ACRYLIC INTRAOCULAR LENS, MODEL ZA9003|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|05/23/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR THE UV CHROMOPHORE RAW MATERIAL.
P990080|S037|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS MULTIFOCAL INTRAOCULAR LENS, MODEL ZMA00|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|05/23/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR THE UV CHROMOPHORE RAW MATERIAL.
P080010|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL INTRAOCULAR LENS, MODEL NXG1|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|05/23/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR THE UV CHROMOPHORE RAW MATERIAL.
P960028|S036|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL INTRAOCULAR LENS, MODEL NXG1|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|05/23/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR THE UV CHROMOPHORE RAW MATERIAL.
P020036|S024|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|05/22/2012|||OK30|CHANGES TO THE SEALING EQUIPMENT AND ADDITIONS TO IMPROVE THE VISUAL INSPECTION PROCESS.
P030047|S025|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|05/22/2012|||OK30|CHANGES TO THE SEALING EQUIPMENT AND ADDITIONS TO IMPROVE THE VISUAL INSPECTION PROCESS.
P100049|S001|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/23/2012|06/22/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040024|S058|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice||N|04/23/2012|05/23/2012|||OK30|TEST LABORATORY FOR ANALYSIS OF A COMPONENT TO BE CHANGED TO AN INTERNAL CHEMICAL QUALITY CONTROL LABORATORY AS OPPOSED TO THE CURRENT CONTRACT TESTING LABORATORY.
P030006|S025|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|05/17/2012|||OK30|CHANGE IN A THERMOCOUPLE WIRE JOINT MANUFACTURING PROCESS.
P010019|S031|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|05/23/2012|||OK30|USE OF AN IMPROVED GAS CHROMATOGRAPHY (GC) TEST METHOD FOR ASSESSING RAW MATERIALS.
P000036|S011|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2012|09/05/2012|||APPR|APPROVAL FOR THE QUALIFICATION OF AN ALTERNATE SUPPLIER FOR A CRITICAL DEVICE COMPONENT.
P100041|S009|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)|NPT|CV|30-Day Notice||N|04/23/2012|05/09/2012|||OK30|ALTERNATE RECEIVING INSPECTION SITE.
P000039|S045|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND MULTI-FENESTRATED SEPTAL OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2012|05/24/2012|||OK30|MODIFY THE STATISTICAL SAMPLING PLAN FOR RECEIVING INSPECTIONS OF COMPONENTS OF THE SUBJECT DEVICES.
P020024|S035|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2012|05/24/2012|||OK30|MODIFY THE STATISTICAL SAMPLING PLAN FOR RECEIVING INSPECTIONS OF COMPONENTS OF THE SUBJECT DEVICES.
P040040|S020|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2012|05/24/2012|||OK30|MODIFY THE STATISTICAL SAMPLING PLAN FOR RECEIVING INSPECTIONS OF COMPONENTS OF THE SUBJECT DEVICES.
P050011|S003|BAXTER HEALTHCARE CORP.|1620 WAUKEGAN ROAD||MCGAW PARK|IL|60085||BARRIER, ABSORABLE, ADHESION|ADEPT ADHESION REDUCTION SOLUTION|MCN|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/24/2012|05/17/2012|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THAT EXSUFFLATION SHOULD OCCUR PRIOR TO INSTILLING ADEPT.
P020036|S025|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2012|05/22/2012|||OK30|IMPLEMENTATION OF A VISION SYSTEM FOR THE INSPECTION OF POUCH SEALS.
P030017|S133|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2012|05/24/2012|||OK30|ADDITIONAL VERIFICATION STEP TO BE ADDED DURING MANUFACTURE TESTING OF THE REMOTE CONTROL DEVICE OF THE DEVICE.
P110023|S001|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2012|06/06/2012|||OK30|ADDITION OF A 7-PALLET STERILIZER VESSEL AT THE CONTRACT STERILIZER.
P040024|S059|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2012|05/24/2012|||OK30|BACK-UP ANALYTICAL LABORATORY FOR WATER FOR INJECTION (WFI), PURIFIED WATER (PW) AND CLEAN STEAM.
P980016|S351|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DF4 & ICD, PROTECTA DF4 & ICD & XT DF4 & XT ICD, SECURA DF4 & ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2012|05/23/2012|||OK30|CHANGE TO THE DIE ATTACH CURE PROCESS FOR SELECTED SILICON-CONTROLLED RECTIFIER COMPONENTS.
P010031|S303|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA & DF4, MAXIMO II CRT-D & DF4, PROTECTA CRT-D & DF4 & XT CRT-D & XT DF4||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2012|05/23/2012|||OK30|CHANGE TO THE DIE ATTACH CURE PROCESS FOR SELECTED SILICON-CONTROLLED RECTIFIER COMPONENTS.
P990027|S017|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217A EXCIMER LASER SYSTEM AND TECHNOLAS 217Z ZYOPTIX SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2012|01/18/2013|||APPR|APPROVAL FOR AN ALTERNATE SOURCE TO PRODUCE THE THYRATRON POWER SUPPLY AND LASER HEAD ASSEMBLIES.
P100049|S002|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/23/2012|06/22/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110013|S003|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/24/2012|||OK30|CHANGE TO THE SAMPLING PLAN FOR ROUTINE END-PRODUCT BACTERIAL ENDOTOXIN TESTING.
P110001|S003|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|RX HECULINK ELITE RENAL STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/27/2012|06/26/2012|||APPR|APPROVAL FOR POST-APPROVAL STUDY PROTOCOL.
P960040|S258|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/18/2012|||OK30|CHANGE TO AN EXISTING MANUFACTURING PROCESS.
P010012|S288|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/18/2012|||OK30|CHANGE TO AN EXISTING MANUFACTURING PROCESS.
P030005|S083|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR CRT-P DEVICES|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/18/2012|||OK30|CHANGE TO AN EXISTING MANUFACTURING PROCESS.
P900056|S114|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDWIRE WITH WIRECLIP TORQUER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P920047|S052|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P980003|S036|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P020009|S084|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P020025|S034|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P030025|S097|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P040016|S087|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P060006|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P060008|S088|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P100023|S042|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2012|05/23/2012|||OK30|UPGRADES TO STERILIZATION EQUIPMENT.
P990046|S029|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|MEDTRONIC OPEN PIVOT BILEAFLET HEART VALVED|LWQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/26/2012|06/25/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060025|S009|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|ATS 3F AORTIC BIOPROSTHESIS|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/30/2012|10/26/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100039|S001|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS2 ASSAY|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/2012|10/03/2013|||APPR|APPROVAL FOR THE ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND ADVIACENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL FOR USE ON THE ADVIA CENTAUR CP INSTRUMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIALAND IS INDICATED FOR: ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY - THE ADVIA CENTAUR ANTI-HBS2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA (EDT A, LITHIUM-HEPARINIZED, OR SODIUM-HEPARINIZED) AND NEONATAL SAMPLES USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALSDISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THIS ASSAY HAS NOT BEEN FDA-CLEARED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL - FOR IN VITRO. DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS2 ASSAY ON THE ADVIACENTAUR SYSTEMS. THE PERFORMANCE OF THE ANTI-HBS2 QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.
P100040|S008|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/2012|10/26/2012|12M-1109|11/08/2012|APPR|APPROVAL FOR THE VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF ISOLATED LESIONS (EXCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: ILIAC OR FEMORAL ARTERY ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; NONANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18 TO 42 MM (FUSIFORM AND SACCULAR ANEURYSMS/ PENETRATING ULCERS) OR 18 MM TO 44 MM (BLUNT TRAUMATIC AORTIC INJURIES); AND NONANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS >= 20 MM.
P020004|S073|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|05/01/2012|05/30/2012|||OK30|CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.
P040027|S028|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice||N|05/01/2012|05/30/2012|||OK30|CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.
P040037|S042|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice||N|05/01/2012|05/30/2012|||OK30|CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.
P040043|S048|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|05/01/2012|05/30/2012|||OK30|CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.
P050006|S027|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice||N|05/01/2012|05/30/2012|||OK30|CHANGE TO THE AUTOMATED MANUFACTURING AND TESTING DOCUMENTATION PROCESS.
P840001|S213|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MODEL 74001 1X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION;MODEL 74002 2X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2012|05/30/2012|||OK30|TIGHTEN THE ACCEPTANCE CRITERIA FOR THE TITANIUM CONTENT OF THE UN-INSULATED WIRE AND QUALIFY AN ALTERNATE SUPPLIER OF THE ETHYLENE TETRA-FLUORO-ETHYLENE (ETFE) MICRO-EXTRUSION PROCESS.
P960009|S144|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MODEL 640011X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION;MODEL 64002 2X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2012|05/30/2012|||OK30|TIGHTEN THE ACCEPTANCE CRITERIA FOR THE TITANIUM CONTENT OF THE UN-INSULATED WIRE AND QUALIFY AN ALTERNATE SUPPLIER OF THE ETHYLENE TETRA-FLUORO-ETHYLENE (ETFE) MICRO-EXTRUSION PROCESS.
P010047|S020|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALNAT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2012|05/30/2012|||OK30|ADD AN ADDITIONAL SUPPLIER FOR STERILE WATER.
P080020|S002|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2012|10/10/2012|||APPR|APPROVAL FOR THE USE OF DEDICATED MANUFACTURING EQUIPMENT FOR ADDITIONAL PURPOSES.
P910001|S055|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2012|05/30/2012|||OK30|AUTOMATION OF LOT NUMBER ASSIGNMENT FOR PRINTING.
P960042|S038|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2012|05/30/2012|||OK30|AUTOMATION OF LOT NUMBER ASSIGNMENT FOR PRINTING.
P010031|S304|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/01/2012|06/29/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010031|S305|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/02/2012|09/17/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050006|S028|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2012|06/01/2012|||OK30|MODIFICATION TO A SPECIFICATION OF A RAW COMPONENT FOR THE MANUFACTURING OF THE SUBJECT DEVICE.
P020009|S085|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS MONORAIL OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2012|05/30/2012|||OK30|REMOVAL OF WAIST LENGTH IN-PROCESS INSPECTION STEPS.
P040016|S088|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2012|05/30/2012|||OK30|REMOVAL OF WAIST LENGTH IN-PROCESS INSPECTION STEPS.
P060006|S028|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2012|05/30/2012|||OK30|REMOVAL OF WAIST LENGTH IN-PROCESS INSPECTION STEPS.
P100023|S043|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2012|05/30/2012|||OK30|REMOVAL OF WAIST LENGTH IN-PROCESS INSPECTION STEPS.
P110010|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2012|05/30/2012|||OK30|REMOVAL OF WAIST LENGTH IN-PROCESS INSPECTION STEPS.
P990027|S018|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2012|05/17/2013|||APPR|APPROVAL FOR THE ADDITION OF THE ADVANCED PLANOSCAN SOFTWARE TO BE USED WITH THE DEVICE.
P110029|S001|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT I1000 SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2012|01/10/2013|||APPR|APPROVAL FOR THE MIGRATION OF THE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY ASSAYS TO THE ARCHITECT I LOOOSR ANALYZER.
P060040|S020|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II VAS|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2012|05/31/2012|||OK30|CHANGES TO THE SUPPLIER WHO MANUFACTURES THE HEARTMATE II LVAS BATTERIES.
P000035|S008|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM|MPI|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2012|09/06/2012|||APPR|APPROVAL FOR CHANGES IN DEGREASING SOLVENT, CUTTING/MACHINE LUBRICANTS AND PACKAGING EQUIPMENT.
P000023|S008|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM|LZD|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2012|09/06/2012|||APPR|APPROVAL FOR CHANGES IN DEGREASING SOLVENT, CUTTING/MACHINE LUBRICANTS AND PACKAGING EQUIPMENT.
P110019|S018|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/29/2012|10/05/2012|||APPR|APPROVAL TO ALLOW THE CORRESPONDING DRUG CONTENT VALUES TO BE CENTERED AROUND 100% LABEL CLAIM AND PROVIDE INCREASED PROBABILITY THAT INDIVIDUAL UNITS WILL HAVE A DRUG CONTENT OF GREATER THAN 90% OF THE LABELED CLAIM TO MEET THE CONDITION OF APPROVAL THAT "WITHIN 12 MONTHS OF PMA APPROVAL, YOU SHOULD SUBMIT A PMA SUPPLEMENT REQUESTING APPROVAL TO TIGHTEN THE IN-PROCESS COATING WEIGHT GAIN SPECIFICATION OR IMPLEMENT PROCEDURES TO RE-COAT STENTS WITH LESS THAN 95% COATING WEIGHT GAIN UPON IN-PROCESS INSPECTION.  THE COMPANY HAS PROVIDED THE ALTERNATIVE SOLUTION.
P040037|S043|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2012|05/30/2012|||OK30|ADDITION OF LEAK TESTING AND DRYING OF GRAFT COMPONENTS AT THE MEDICAL EAST MANUFACTURING FACILITY.
P010012|S289|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, COGNIS, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2012|07/25/2012|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE UNFILTERED FEEDTHROUGH.
P960040|S259|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, TELIGEN, ENERGEN AND PUNCTUA ICD DEVICES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2012|07/25/2012|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE UNFILTERED FEEDTHRU.
P030024|S019|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice||N|05/04/2012|05/24/2012|||OK30|ADDITION OF A SUPPLIER FOR NEGATIVE HUMAN PLASMA.
P060040|S021|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/04/2012|06/05/2012|||APPR|APPROVAL FOR THE HEARTMATE II UNIVERSAL PERCUTANEOUS BEND RELIEF REPAIR KIT.
P060023|S003|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|BRYAN CERVICAL DISC|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2012|11/30/2012|||APPR|APPROVAL FOR A REVISION TO THE BIOBURDEN ENUMERATION TEST FREQUENCY FOR ETHYLENE OXIDE.
P010019|S032|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON B SOFT CONTACT LENSES|LPM|OP|30-Day Notice||N|05/04/2012|05/22/2012|||OK30|ADDITION OF AN ALTERNATE RAW MATERIAL SUPPLIER FOR BETACON MACROMER USED IN THE FORMULATION OF LOTRAFILCON B SOFT CONTACT LENSES.
P020018|S043|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/04/2012|10/01/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020018|S044|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/04/2012|12/12/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050033|S015|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|S-15 HYDRELLE|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2012|10/22/2012|||APPR|APPROVAL FOR A CHANGE IN THE SAMPLE PREPARATION PROCEDURE FOR HPLC TESTING.
P860057|S089|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2012|05/30/2012|||OK30|EXPANSION OF A CLEANROOM.
P870056|S049|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2012|05/30/2012|||OK30|EXPANSION OF A CLEANROOM.
P870077|S044|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2012|05/30/2012|||OK30|EXPANSION OF A CLEANROOM.
P000007|S031|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2012|05/30/2012|||OK30|EXPANSION OF A CLEANROOM.
P010041|S033|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2012|05/30/2012|||OK30|EXPANSION OF A CLEANROOM.
P100041|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2012|05/30/2012|||OK30|EXPANSION OF A CLEANROOM.
P110035|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2012|06/06/2012|||OK30|UPDATE TO A SUPPLIER GEL RATING METHODOLOGY AND SPECIFICATION.
P000040|S024|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|05/07/2012|06/19/2012|||APPR|APPROVAL FOR MINOR CHANGES TO THE ELECTRICAL DESIGN OF THE CONTROLLER.
P940015|S026|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC AND SYNVISC-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2012|06/22/2012|||OK30|ADDITION OF A NEW WATER TREATMENT SYSTEM.
P840001|S214|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2012|06/05/2012|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUB-TIER SUPPLIER FOR COMPONENTS USED IN PATIENT PROGRAMMERS.
P860004|S168|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED DRUG PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2012|06/05/2012|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUB-TIER SUPPLIER FOR COMPONENTS USED IN PATIENT PROGRAMMERS.
P960009|S145|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2012|06/05/2012|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUB-TIER SUPPLIER FOR COMPONENTS USED IN PATIENT PROGRAMMERS.
P970004|S134|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2012|06/05/2012|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUB-TIER SUPPLIER FOR COMPONENTS USED IN PATIENT PROGRAMMERS.
P080025|S031|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2012|06/05/2012|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUB-TIER SUPPLIER FOR COMPONENTS USED IN PATIENT PROGRAMMERS.
P030017|S134|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/07/2012|12/21/2012|||APPR|APPROVAL FOR THE PRECISION SPECTRA SYSTEM WHICH INCLUDES THE FOLLOWING COMPONENTS:1) MODEL SC-1132 PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR (LPG); 2)MODEL SC-440 I PRECISION SPECTRA LPG PORT PLUG; 3) MODEL SC-5132 PRECISION SPECTRA EXTERNAL TRIAL STIMULATOR; 4) MODEL SC-6360-32 PRECISION SPECTRA PATIENT TRIAL BELT; 4) MODEL SC-6500-32 PATIENT TRIAL KIT; 5) MODEL SC-5232 PRECISION SPECTRA  REMOTE CONTROL; 6) MODEL SC-5532-1 PRECISION SPECTRA REMOTE CONTROL KIT; 7) MODEL NM-631 0 AND NM-621 0 USB POWER SUPPLY; AND 8) MODEL NM-621 0 REMOTE CONTROL HOLSTER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRECISION SPECTRA SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS,INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
P960040|S260|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNTUA ICD DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2012|06/04/2012|||OK30|UPDATES TO AN EXISTING COMPONENT INSPECTION PROCESS.
P010012|S290|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2012|06/04/2012|||OK30|UPDATES TO AN EXISTING COMPONENT INSPECTION PROCESS.
P910001|S056|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS EXCIMER LASER|LPC|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/08/2012|07/03/2012|||APPR|APPROVAL FOR A CHANGE TO THE RADIO FREQUENCY (RF) ABSORPTION MATERIAL FOR THE CVX-300P MODEL EXCIMER LASER.
P100021|S017|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2012|06/07/2012|||OK30|INCLUSION OF MANUFACTURING FOR AN ADDITIONAL STENT RING SIZE FOR THE DEVICE AT EMPALME, MEXICO.
P030017|S135|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2012|06/06/2012|||OK30|CHANGE TO THE WELDING PROCESS IN THE MANUFACTURING OF THE DEVICE.
P020056|S017|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2012|07/18/2012|||OK30|ADDITION OF AN INCOMING VERIFICATION STEP FOR SILICONE ELASTOMER RAW MATERIALS METALS TESTING.
P900009|S033|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|ULTRASOUND BONE HEALING SYSTEM|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2012|06/06/2012|||OK30|CHANGE IN SUPPLIER.
P910077|S121|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/09/2012|06/19/2012|||APPR|APPROVAL FOR THE ADDITION OF THE OPTION TO CONNECT THE LATTITUDE COMMUNICATOR TO AN OFF-THE-SHELF COMMERCIALLY AVAILABLE CELLULAR MODEM.
P990074|S024|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2012|07/23/2012|||OK30|ADDITION OF A STEP TO THE INCOMING INSPECTION PROCEDURES FOR THE RAW MATERIALS USED IN THE MANUFACTURE OF THE DEVICE.
P840001|S215|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, SYNERGY|LGW|NE|30-Day Notice||N|05/09/2012|06/08/2012|||OK30|IMPLEMENTATION OF A NEW SEALER USED TO HEAT SEAL ADHESIVE COATED LIDS TO THERMOFORMED PLASTIC BLISTER STYLE TRAYS.
P080025|S032|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice||N|05/09/2012|06/08/2012|||OK30|IMPLEMENTATION OF A NEW SEALER USED TO HEAT SEAL ADHESIVE COATED LIDS TO THERMOFORMED PLASTIC BLISTER STYLE TRAYS.
P960009|S146|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA, SOLETRA, KINETRA|MHY|NE|30-Day Notice||N|05/09/2012|06/08/2012|||OK30|IMPLEMENTATION OF A NEW SEALER USED TO HEAT SEAL ADHESIVE COATED LIDS TO THERMOFORMED PLASTIC BLISTER STYLE TRAYS.
P970004|S135|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice||N|05/09/2012|06/08/2012|||OK30|IMPLEMENTATION OF A NEW SEALER USED TO HEAT SEAL ADHESIVE COATED LIDS TO THERMOFORMED PLASTIC BLISTER STYLE TRAYS.
P840001|S216|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice||N|05/09/2012|06/07/2012|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONICS MANUFACTURING FACILITIES.
P860004|S169|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED IMPLANTABLE INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2012|06/07/2012|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONICS MANUFACTURING FACILITIES.
P080025|S033|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice||N|05/09/2012|06/07/2012|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONICS MANUFACTURING FACILITIES.
P960009|S147|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice||N|05/09/2012|06/07/2012|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONICS MANUFACTURING FACILITIES.
P970004|S136|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS|EZW|GU|30-Day Notice||N|05/09/2012|06/07/2012|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONICS MANUFACTURING FACILITIES.
P910066|S026|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS|LOF|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2012|08/10/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE  AND ACCEPTANCE ACTIVITIES LOCATED IN VISTA, CALIFORNIA
P050018|S017|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/10/2012|01/10/2013|||APPR|APPROVAL FOR A NEW BALLOON LENGTH, AND TO INCORPORATE DESIGN, MANUFACTURING PROCESS AND LABELING CHANGES FOR THE RAPID EXCHANGE (RX) DELIVERY SYSTEM.
P860004|S170|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2012|06/06/2012|||OK30|MANUFACTURING CHANGE TO THE LASER WELD PROCESS FOR THE SYNCHROMED II INFUSION PUMP, 8637.
P980016|S352|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DF4/ICD, PROTECTA DF4/ICD/XT DF4/XT ICD, SECURA DF4/ ICD & VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2012|06/04/2012|||OK30|INCORPORATE PLATING BAKE TEST AS PART OF THE MONITORING CONTROL PLAN PERFORMED AT THE SUPPLIER.
P010031|S306|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D/DF4, PROTECTA CRT-D/DF4/XT CRT-D/XT DF4||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2012|06/04/2012|||OK30|INCORPORATE PLATING BAKE TEST AS PART OF THE MONITORING CONTROL PLAN PERFORMED AT THE SUPPLIER.
P010012|S291|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA CRT-D, ENERGEN CRT-D, INCEPTA CRT-D|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/2012|06/19/2012|||APPR|APPROVAL FOR MODIFYING THE DESIGN SPECIFICATIONS FOR THE SPOT WELD ANCHOR POST USED IN ICD AND CRT-D PULSE GENERATOR (PG) HEADERS AND THE LEAF SPRING HOUSING BLOCK USED IN THE LV-1 FOR CRT-D PULSE GENERATOR HEADERS.
P960040|S261|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA ICD, ENEGEN ICD, INCEPTA ICD|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/2012|06/19/2012|||APPR|APPROVAL FOR MODIFYING THE DESIGN SPECIFICATIONS FOR THE SPOT WELD ANCHOR POST USED IN ICD AND CRT-D PULSE GENERATOR (PG) HEADERS AND THE LEAF SPRING HOUSING BLOCK USED IN THE LV-1 FOR CRT-D PULSE GENERATOR HEADERS.
P050047|S025|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice||N|05/11/2012|06/07/2012|||OK30|SCALE-UP OF AN IN-PROCESS MANUFACTURING STEP OF THE DEVICE.
P110019|S019|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice||N|05/11/2012|06/07/2012|||OK30|CHANGES TO THE EXTRUDED TUBING PROCESS.
P110028|S001|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice||N|05/11/2012|06/07/2012|||OK30|CHANGES TO THE EXTRUDED TUBING PROCESS.
P110001|S004|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|HERCULINK ELITE RENAL STENT SYSTEM|NIN|CV|30-Day Notice||N|05/11/2012|06/07/2012|||OK30|CHANGES TO THE EXTRUDED TUBING PROCESS.
P060019|S021|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE BLU SP ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER|OAD|CV|Real-Time Process||N|05/11/2012|07/10/2012|||APPR|APPROVAL FOR AN ALTERNATIVE PACKAGE CONFIGURATION FOR THE SUBJECT ABLATION CATHETERS.  THE NEW PACKAGE CONFIGURATION WOULD CHANGE THE PREVIOUS COILED TRAY CONFIGURATION TO A TRAY WITH A STRAIGHT CONFIGURATION.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SAFIRE BLU SP IRRIGATED ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER, AND SAFIRE BLU DUO SP ABLATION CATHETER.
P110016|S002|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE BLU DUO SP ABLATION CATHETERS|OAD|CV|Real-Time Process||N|05/11/2012|07/10/2012|||APPR|APPROVAL FOR AN ALTERNATIVE PACKAGE CONFIGURATION FOR THE SUBJECT ABLATION CATHETERS.  THE NEW PACKAGE CONFIGURATION WOULD CHANGE THE PREVIOUS COILED TRAY CONFIGURATION TO A TRAY WITH A STRAIGHT CONFIGURATION.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SAFIRE BLU SP IRRIGATED ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER, AND SAFIRE BLU DUO SP ABLATION CATHETER.
P980016|S353|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2012|06/13/2012|||OK30|ALIGN HEADER MANUFACTURING PROCESSES OF THE PROTECTA XT VR (D314VRM), PROTECTA VR (D334VRM), SECURA VR (D204VRM) AND MAXMIO II VR (D264VRM) DF4 ICDS WITH CURRENTLY MANUFACTURED DEVICES.
P070015|S093|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2012|02/01/2013|||APPR|APPROVAL FOR MODIFICATION OF A DRUG RELEASE PROFILE TEST METHOD.
P000039|S046|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL AND CRIBRIFORM OCCLUDERS|MAE|CV|30-Day Notice||N|05/14/2012|06/06/2012|||OK30|USE OF DIFFERENT BRAIDING EQUIPMENT TO REDUCE THE POTENTIAL FOR ABRASION OF NITINOL WIRE.
P020024|S036|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|30-Day Notice||N|05/14/2012|06/06/2012|||OK30|USE OF DIFFERENT BRAIDING EQUIPMENT TO REDUCE THE POTENTIAL FOR ABRASION OF NITINOL WIRE.
P040040|S021|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice||N|05/14/2012|06/06/2012|||OK30|USE OF DIFFERENT BRAIDING EQUIPMENT TO REDUCE THE POTENTIAL FOR ABRASION OF NITINOL WIRE.
P010030|S032|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2012|07/13/2012|||APPR|APPROVAL FOR 2 MECHANICAL DESIGN MODIFICATIONS TO THE METHOD OF ATTACHING THE HOOK COMPONENT OF THE HOOK AND LOOP FASTENERS TO THE ECG ELECTRODE HOUSING.
P890055|S040|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2012|06/25/2012|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE PROGRAMMABLE INFUSION SYSTEM. THESE MODIFICATIONS WERE DATA INTEGRITY CHECK IMPROVEMENT, RESOLUTION OF CONTROL UNIT KEYBOARD, FRAME CHECK SEQUENCE ALGORITHM UPGRADE, SOFTWARE ANOMALIES 015, 016, 017, 020 FIX, AND IMPROVEMENT OF THE BRIDGE BOLUS, PRIMING BOLUS AND SINGLE BOLUS PROCESSES.
P910073|S102|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE 4-SITE LEAD AND ACCESSORY MODELS|LWS|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/14/2012|12/21/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P960040|S262|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN 4-SITE HEADER ICD MODELS|LWP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/14/2012|12/21/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P010012|S292|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS 4-SITE HEADER CRT-D MODELS|LWP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/14/2012|12/21/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P970037|S008|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA HAFP TEST SYSTEM|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2012|06/14/2012|||OK30|SECOND ALTERNATIVE TYPE OF TOPO (TRIOCTYLPHOSPHINE OXIDE) RAW MATERIAL TYPE USED IN THE MANUFACTURING OF THE ENHANCEMENT SOLUTION FOR THE DEVICE.
P110023|S002|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2012|06/14/2012|||OK30|REDUCTION OF THE UV INTENSITY USED TO CURE THE BONDING ADHESIVE OF THE MANIFOLD SUB- ASSEMBLY PROCESS.
P050053|S025|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/16/2012|06/27/2012|||APPR|APPROVAL FOR THE PROPOSED LABELING REVISIONS RELATED TO THE APPEARANCE OF THE RECONSTITUTED PRODUCT AND WARNING STATEMENT ABOUT USE IN PATIENTS SUSPECTED OF HAVING CANCER AT THE PRODUCT APPLICATION SITE.
P020045|S043|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2012|06/14/2012|||OK30|NEW SUPPLIER FOR A PRESSURE TRANSDUCER COMPONENT.
P950029|S068|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR AND DR, ESPRIT SR AND DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2012|06/11/2012|||OK30|ALTERNATE MANUFACTURING EQUIPMENT.
P980049|S073|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR, DR RF VR & RF DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2012|06/11/2012|||OK30|ALTERNATE MANUFACTURING EQUIPMENT.
P060027|S040|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D, RF CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2012|06/11/2012|||OK30|ALTERNATE MANUFACTURING EQUIPMENT.
P790002|S028|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET EBI BONE HEALING SYSTEM|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/2012|02/08/2013|||APPR|APPROVAL FOR A MODIFIED, REDESIGNED, ELECTRONIC CONTROLLER WITH A NON-REPLACEABLE LITHIUM-ION BATTERY AND A NEW EXTREMITY BAND ACCESSORY.
P980049|S074|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM RF VR & RF DR ICD|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2012|05/30/2012|||OK30|THE FOLLOWING CHANGES:  1) AN ALTERNATE REFLOW OVEN WITH AN UPDATED REFLOW SOLDERING PROFILE AND AN ALTERNATE COMPONENT CARRIER; 2) AN UPDATE TO THE REWORK PROCESS; 3) IN-SOURCING OF AN ELECTRONIC ASSEMBLY; 4) CLEAN ROOM LAYOUT MODIFICATION AT SALUGGIA, ITALY, PLANT, AND; 5)AN ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS.
P060027|S041|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF CRT-D|NIK|CV|30-Day Notice||N|05/16/2012|05/30/2012|||OK30|THE FOLLOWING CHANGES:  1) AN ALTERNATE REFLOW OVEN WITH AN UPDATED REFLOW SOLDERING PROFILE AND AN ALTERNATE COMPONENT CARRIER; 2) AN UPDATE TO THE REWORK PROCESS; 3) IN-SOURCING OF AN ELECTRONIC ASSEMBLY; 4) CLEAN ROOM LAYOUT MODIFICATION AT SALUGGIA, ITALY, PLANT, AND; 5)AN ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS.
P010031|S307|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2012|06/11/2012|||OK30|CHANGE TO THE CONNECTOR CONTACT ASSEMBLY PULL TEST SAMPLE CONFIGURATION.
P980016|S354|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SECURA, MAXIMOII, PROTECTA, PROTECTA XT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2012|06/11/2012|||OK30|CHANGE TO THE CONNECTOR CONTACT ASSEMBLY PULL TEST SAMPLE CONFIGURATION.
P980035|S271|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2012|06/14/2012|||OK30|UPDATE THE HYBRID TEST SOFTWARE.
P010015|S163|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2012|06/14/2012|||OK30|UPDATE THE HYBRID TEST SOFTWARE.
P980016|S355|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2012|06/15/2012|||OK30|UPDATE THE SOFTWARE ON A HYBRID TESTER USED FOR PRODUCT ACCEPTANCE TEST.
P010031|S308|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2012|06/15/2012|||OK30|UPDATE THE SOFTWARE ON A HYBRID TESTER USED FOR PRODUCT ACCEPTANCE TEST.
P840001|S217|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS INS ITREL FAMILY, SCS INS SYNERGY FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2012|06/15/2012|||OK30|CHANGE TO AUTOMATE THE MANUAL RATE CHECK (POST- STERILIZATION TEST) FOR THE IMPACTED DEVICES.
P960009|S148|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS INS SOLETRA FAMILY, DBS INS KINETRA FAMILY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2012|06/15/2012|||OK30|CHANGE TO AUTOMATE THE MANUAL RATE CHECK (POST- STERILIZATION TEST) FOR THE IMPACTED DEVICES.
P060040|S022|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2012|07/05/2012|||APPR|APPROVAL FOR CHANGES TO THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) REGARDING DISCONTINUATION OF THE EMERGENCY POWER PACK (EPP) AND SOME MINOR LABELING MODIFICATIONS.
P970018|S025|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2012|11/08/2012|||APPR|APPROVAL FOR A SUPPLIER CHANGE TO THE RAW MICROSOPE SLIDE, A CRITICAL COMPONENT IN THE DEVICE.
P080004|S011|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|ISERT MODEL 251 PRELOADED POSTERIOR CHAMBER IOL LEVEL B MODIFICATION OF PARENT IOL|HQL|OP|Normal 180 Day Track||N|05/18/2012|07/10/2013|||APPR|APPROVAL FOR THE ISERT® MODEL 251 PRELOADED POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) AND ISERT® MODEL 250 PRELOADED POSTERIOR CHAMBER IOL.
P100021|S018|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2012|12/26/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MÉXICO EG IN EMPALME SONORA, MEXICO, FOR STENT GRAFT SEWING.
P070026|S006|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2012|06/15/2012|||OK30|CHANGES TO THE DEVICE STERILE PACKAGING.
P090002|S004|DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2012|06/15/2012|||OK30|CHANGES TO THE DEVICE STERILE PACKAGING.
P040023|S022|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DUROLOC OPTION CERAMIC HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2012|06/15/2012|||OK30|CHANGES TO THE DEVICE STERILE PACKAGING.
P950020|S050|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CORONARY FLEXTOME CUTTING BALLOON||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2012|06/18/2012|||OK30|PROCESS CHANGE AND RELOCATION FOR PROXIMAL CATHETER MARKING.
P110028|S002|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2012|06/20/2012|||OK30|REDUCTION OF SAMPLING FREQUENCY FOR A MANUFACTURING PROCESS.
P910018|S016|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2012|06/19/2012|||OK30|CHANGE IN THE LOCATION OF A SUPPLIER¿S MANUFACTURING FACILITY THAT PRODUCES COMPONENTS USED IN THE MANUFACTURING OF THE DEVICE.
P060002|S026|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2012|06/18/2012|||OK30|ADDITION OF A QUALITY CONTROL MEASURING MICROSCOPE FOR COMPONENT INSPECTION.
P080007|S014|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXXVASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2012|06/18/2012|||OK30|ADDITION OF A QUALITY CONTROL MEASURING MICROSCOPE FOR COMPONENT INSPECTION.
P070015|S094|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2012|09/19/2012|||APPR|APPROVAL TO CHANGE THE COATING INTEGRITY SPECIFICATION FOR THE 28 MM LENGTH STENTS TO ALIGN WITH THAT OF THE 33 MM AND 38 MM STENTS FOR THE XIENCE FAMILY OF PRODUCTS.
P110019|S020|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2012|09/19/2012|||APPR|APPROVAL TO CHANGE THE COATING INTEGRITY SPECIFICATION FOR THE 28 MM LENGTH STENTS TO ALIGN WITH THAT OF THE 33 MM AND 38 MM STENTS FOR THE XIENCE FAMILY OF PRODUCTS.
P980016|S356|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2012|06/19/2012|||OK30|UPDATE TO A SOFTWARE PACKAGE USED IN PRODUCT ACCEPTANCE TESTING.
P010031|S309|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2012|06/19/2012|||OK30|UPDATE TO A SOFTWARE PACKAGE USED IN PRODUCT ACCEPTANCE TESTING.
P870072|S048|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2012|06/18/2012|||OK30|AUTOMATION OF THE OVEN-DRYING PROCESS.
P100005|S001|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|M-VU ALGOIRITHM ENGINE|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/21/2012|10/01/2012|||APPR|APPROVAL FOR ALGORITHM UPDATES AND THE EXPANSION TO MULTIPLE MAMMOGRAPHY SYSTEMS.
P030054|S222|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2012|06/20/2012|||OK30|ALTERNATE SUPPLIER OF THE RF ANTENNA MODULE.
P080011|S012|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COPPER VISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice||N|05/22/2012|06/19/2012|||OK30|RELOCATION AND REVALIDATION OF A MANUFACTURING LINE NUMBER 3.
P020047|S048|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2012|06/18/2012|||OK30|REMOVAL OF A FINAL PRODUCT TEST FOR RELIABILITY ENGINEERING.
P110019|S021|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2012|06/18/2012|||OK30|REMOVAL OF A FINAL PRODUCT TEST FOR RELIABILITY ENGINEERING.
P900060|S050|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2012|11/05/2012|||APPR|APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR MANUFACTURING OF THE GRAPHITE SUBSTRATE OF VALVE LEAFLETS.
P900060|S051|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2012|06/29/2012|||OK30|ADDING MACHINING OPERATIONS FOR A COMPONENT TO YOUR SORIN BIOMEDICA CARDIO S.R.L. FACILITY.
P920015|S091|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SINGLE COIL DF4, ACTIVE FIXATION LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2012|07/02/2012|||APPR|APPROVAL FOR A CHANGE TO THE CURRENTLY APPROVED MODEL 6935 SPRINTQUATTRO SECURE S LEAD WHICH IS A SINGLE DEFIBRILLATION COIL IS-1/DF-1 ACTIVE FIXATION LEAD FOR THE CREATION OF A NEW SPRINT QUATTRO SECURE S SINGLE DEFIBRILLATION COIL DF4 ACTIVE FIXATION LEAD, MODEL 6935M.
P860004|S171|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|IMPLANTABLE SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2012|06/18/2012|||OK30|MANUFACTURING CHANGE TO THE READING OF THE SERIAL NUMBER ON A COMPONENT FOR THE SYNCHROMED II IMPLANTABLE INFUSION PUMP, MODELS AND 8637-20 AND 8637-40.
P970003|S148|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|Real-Time Process||N|05/24/2012|07/23/2012|||APPR|APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE UPGRADE FROM VERSION 8.0 TO 8.1 AND THE ADDITION OF A NEW COMPACT FLASHCARD.
P110028|S003|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO, ABSOLUTE PRO LL|NIO|CV|30-Day Notice||N|05/24/2012|06/21/2012|||OK30|REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.
P040012|S045|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK, RX|NIM|CV|30-Day Notice||N|05/24/2012|06/21/2012|||OK30|REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.
P110001|S005|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|HERCULINK ELITE, RX|NIN|CV|30-Day Notice||N|05/24/2012|06/21/2012|||OK30|REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.
P040038|S025|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT|NIM|CV|30-Day Notice||N|05/24/2012|06/21/2012|||OK30|REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.
P900056|S115|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2012|06/20/2012|||OK30|REMOVAL OF TWO INSPECTION STEPS FROM ROTALINK BURR ASSEMBLY PROCESS.
P060029|S004|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Sealant,polymerizing|ETHICON OMNEX SURGICAL SEALANT|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2012|06/29/2012|||OK30|TRANSFER OF THE INCOMING INSPECTION PROCESS FROM ETHICON, INC. IN RALEIGH, NORTH CAROLINA TO ETHICON LLC IN SAN LORENZO, PUERTO RICO.
P050027|S003|KARL STORZ ENDOSCOPY-AMERICA, INC.|2151 E. GRAND AVE.||EL SEGUNDO|CA|90245||Light source system, diagnostic endoscopic|KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM|OAY|GU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2012|08/27/2012|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION METHOD, STERRAD NX, FOR THE FLUID LIGHT CABLE DEVICE COMPONENT WITHIN THE DEVICE.
P080004|S012|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|ISERT MODEL PC-60AD PACKAGING IMPROVEMENT|HQL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2012|07/17/2012|||APPR|APPROVAL FOR A PACKAGING CONFIGURATION CHANGE FOR THE ISERT MODEL PC-60AD INTRAOCULAR LENS (IOL).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT MODEL 230 AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
P890055|S041|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2012|06/28/2012|||OK30|CHANGES TO THE CLEANING OF COMPONENTS DURING MANUFACTURING.
P910023|S295|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/25/2012|08/09/2012|||APPR|APPROVAL OF MODEL MN5000 VERSION 6.1 SOFTWARE TO BE USED WITH THE MERLIN.NET SYSTEN AND FOR THE MODEL EX2000 VERSION 6.1 SOFTWARE TO BE USED ON MERLIN AT HOME DEVICES.
P030054|S223|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/25/2012|08/09/2012|||APPR|APPROVAL OF MODEL MN5000 VERSION 6.1 SOFTWARE TO BE USED WITH THE MERLIN.NET SYSTEN AND FOR THE MODEL EX2000 VERSION 6.1 SOFTWARE TO BE USED ON MERLIN AT HOME DEVICES.
P810032|S061|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA MULTIPEICE POSTERIOR CHAMBER LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2012|06/21/2012|||OK30|APPROVAL OF THE MONOFILAMENT DRAW LINE SYSTEM.
P930014|S062|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2012|06/21/2012|||OK30|APPROVAL OF THE MONOFILAMENT DRAW LINE SYSTEM.
P040020|S042|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR POSTERIOR CHAMBER LENS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2012|06/21/2012|||OK30|APPROVAL OF THE MONOFILAMENT DRAW LINE SYSTEM.
P010030|S033|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2012|06/22/2012|||OK30|ADDITIONAL WELDING EQUIPMENT.
P010030|S034|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/29/2012|07/25/2012|||APPR|APPROVAL FOR A CHANGE OF PLATING MATERIAL FROM TIN TO GOLD ON THE FOLLOWING COMPONENTS: 1) BOARD-TO-BOARD CONNECTORS ON THE COMPUTER BOARD AND HIGH VOLTAGE BOARD; 2) 12-POSITION JUMPER; AND 3) BOARD-TO-BOARD CONNECTORS ON THE COMPUTER, BEDSIDE, AND BATTERY CONNECTOR BOARDS.
P060011|S004|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7||intraocular lens|C-FLEX ASPHERIC INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/29/2012|07/17/2012|||APPR|APPROVAL FOR THE ADDITION OF AN ASPHERIC OPTICAL SURFACE TO THE ANTERIOR SURFACE OF THE PARENT C-FLEX INTRAOCULAR LENS MODEL 570C (POWER RANGE +8.0 TO + 17.5 D).
P870072|S049|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2012|06/29/2012|||OK30|CHANGE IN SUPPLIER FOR A CRITICAL COMPONENT.
P050012|S047|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2012|06/29/2012|||OK30|MANUFACTURING CHANGE TO SEMI-AUTOMATE THE ASSEMBLY AND ULTRAVIOLET BONDING PROCESS FOR THE CANNULA CARRIER (MT9754-01), PUSHROD CARRIER (MT9755-01) AND NEEDLE CARRIER(MT9576-02) ASSEMBLIES USED IN THE SENSOR APPLICATOR COMPONENT OF THE DEVICE.
P010007|S009|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|IMMULITE AFP ASSAY|LOK|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2012|11/08/2012|||APPR|APPROVAL FOR ELIMINATING THE TEST REDUNDANCY BY USING ONLY THE BIORADLYPHOCHECK IMMUNOASSAY PLUS CONTROLS IN IN-PROCESS COMPONENT TESTING, POST-FILL TESTING AND FINAL KIT COMBINATION TESTING FOR THE ASSESSMENT OF IMMULITE AFP, FREE PSA, AND PSA/3RD GENERATION PSA ASSAY PERFORMANCE.
P930027|S015|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMMULITE PSA ASSAY|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2012|11/08/2012|||APPR|APPROVAL FOR ELIMINATING THE TEST REDUNDANCY BY USING ONLY THE BIORADLYPHOCHECK IMMUNOASSAY PLUS CONTROLS IN IN-PROCESS COMPONENT TESTING, POST-FILL TESTING AND FINAL KIT COMBINATION TESTING FOR THE ASSESSMENT OF IMMULITE AFP, FREE PSA, AND PSA/3RD GENERATION PSA ASSAY PERFORMANCE.
P060005|S008|SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED|GLYN RHONWY. LLANBERIS|CAERNARFON|GWYNEDD, LL55||4EL||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|IMMULITE FPSA ASSAY|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2012|11/08/2012|||APPR|APPROVAL FOR ELIMINATING THE TEST REDUNDANCY BY USING ONLY THE BIORADLYPHOCHECK IMMUNOASSAY PLUS CONTROLS IN IN-PROCESS COMPONENT TESTING, POST-FILL TESTING AND FINAL KIT COMBINATION TESTING FOR THE ASSESSMENT OF IMMULITE AFP, FREE PSA, AND PSA/3RD GENERATION PSA ASSAY PERFORMANCE.
P880086|S219|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2012|07/06/2012|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.
P030035|S097|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2012|07/06/2012|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.
P880006|S080|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2012|07/06/2012|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.
P970013|S049|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2012|07/06/2012|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.
P910023|S296|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE/ ELLIPSE/ FORTIFY ASSURA FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2012|07/06/2012|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.
P030054|S224|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS+HF/QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2012|07/06/2012|||APPR|APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.
P050028|S025|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP / COBAS TAQMAN HBV TEST, V2.0|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2012|06/29/2012|||APPR|APPROVAL FOR CHANGES TO AMPLILINK SOFTWARE V3.3.6.
P060030|S026|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP / COBAS TAQMAN HCV TEST|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|05/30/2012|06/29/2012|||APPR|APPROVAL FOR CHANGES TO AMPLILINK SOFTWARE V3.3.6.
P010031|S310|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, PROTECTA CRT-D, DF4 CRT-D, XT CRT-D, XT DR, XT DF4 CRT-D|NIK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/2012|03/26/2013|||APPR|APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST-APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.
P980016|S357|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD, PROTECTA DF4 ICD, ICD, XT DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO ICD VIRTUOSO II DR/VR ICD|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/2012|03/26/2013|||APPR|APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST-APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.
P980035|S272|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, AT501 DDDRP PACING SYSTEM IPG|NVZ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/2012|03/26/2013|||APPR|APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST-APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.
P010032|S052|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|AXXESS PERCUTANEOUS LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2012|06/22/2012|||OK30|CHANGE TO THE AXXESS LEAD FUNCTIONAL TEST PROCEDURE.
P010012|S293|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LIVIAN, PUNTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2012|06/25/2012|||OK30|ALTERNATE SUPPLIER FOR SEAL PLUGS USED IN THE PULSE GENERATORS.
P960040|S263|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIANT, PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2012|06/25/2012|||OK30|ALTERNATE SUPPLIER FOR SEAL PLUGS USED IN THE PULSE GENERATORS.
P030005|S084|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CRT-P CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P)|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2012|06/25/2012|||OK30|ALTERNATE SUPPLIER FOR SEAL PLUGS USED IN THE PULSE GENERATORS.
P990064|S043|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2012|08/23/2012|||OK30|ADDITION OF AN IN-PROCESS TISSUE QUALITY CONTROL TEST TO MEASURE MUSCLE BAR.
P980016|S358|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2012|06/25/2012|||OK30|UPDATE TO THE VENDOR INSPECTION OF A FLEX COMPONENT, A CHANGE TO THE DIE ATTACH CURE PROCESS AND REMOVAL OF PARALLEL GAP WELDING LINE TESTING.
P010031|S311|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2012|06/25/2012|||OK30|UPDATE TO THE VENDOR INSPECTION OF A FLEX COMPONENT, A CHANGE TO THE DIE ATTACH CURE PROCESS AND REMOVAL OF PARALLEL GAP WELDING LINE TESTING.
P030011|S013|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA COMPANION 2 DRIVER SYSTEM|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/01/2012|07/05/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE DEVICE.
P000008|S028|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2012|10/07/2014|||APPR|APPROVAL FOR DESIGN CHANGES TO THE RAPIDPORT EZ ACCESS PORT, DESIGN CHANGES TO THE RAPIDPORT EZ ACCESS PORT APPLIER, AND PACKAGING CHANGES.
P010032|S053|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RAPID PROGRAMMER|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/01/2012|07/31/2012|||APPR|APPROVAL FOR UPGRADING THE RAPID PROGRAMMER SOFTWARE USED IN THE GENESIS AND EON FAMILY NEUROMODULATION STIMULATORS FROM VERSION 3.3 (MODEL 3831 AND 3832) TO VERSION 3.4 (MODEL 3834).
P010032|S054|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ANTENNA AND PORTABLE CHARGER|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/01/2012|07/12/2012|||APPR|APPROVAL TO REVERSE THE GENDER OF THE CONTACTS OF THE PLUG AND RECEPTACLE ON THE PORTABLE CHARGER (MODELS 3711 AND 3715) I.E., A RECEPTACLE FOR CONNECTING THE CHARGING ANTENNA WILL NOW HAVE FEMALE PINS FOR CONTACTS, WHILE THE MATING PLUG ON THE CHARGING ANTENNA WILL NOW HAVE MALE CONTACTS.  ADDITIONALLY, IT WAS REQUESTED TO CHANGE THE PIN-OUT CONNECTOR FROM A 3 PIN VERSION TO A 4 PIN VERSION.
P050040|S003|INVITROGEN CORPORATION|3175 STALEY RD.||GRAND ISLAND|NY|14072||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|SPOT-LIGHT HER2 CISH KIT|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2012|07/06/2012|||OK30|EXTENSION OF THE EXPIRATION DATE FOR A SINGLE LOT OF HER-2 SPT DNA TEMPLATE (LOT 63013).
P080011|S013|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2012|07/03/2012|||OK30|INSTALLATION OF TWO (UPGRADED INJECTION MOLDING AND CHANGE IN THE DESIGN OF THE PEEL MODULE) ADDITIONAL MANUFACTURING LINES.
P010012|S294|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2012|07/03/2012|||OK30|ADDITION OF THE ALTERNATE SUPPLIERS FOR VARIOUS ELECTRICAL COMPONENTS.
P960040|S264|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2012|07/03/2012|||OK30|ADDITION OF THE ALTERNATE SUPPLIERS FOR VARIOUS ELECTRICAL COMPONENTS.
P870076|S012|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|DISPOSABLE FALOPE-RING BAND APPLICATOR KITS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2012|07/05/2012|||OK30|CHANGE IN THE QUALITY CONTROL METHOD USED DURING THE TRAY AND POUCH MANUFACTURING PROCESS.
P000036|S012|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2012|07/05/2012|||OK30|RELOCATION OF THE QUALITY CONTROL LABORATORIES FROM A TEMPORARY LOCATION TO THE RENOVATED LABORATORY WITHIN THE CURRENT MANUFACTURING FACILITY.
P020009|S086|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/06/2012|||OK30|ADDITION OF NEW SOFTWARE TO INTERFACE WITH THE MANUFACTURING EXECUTION SYSTEM (MES).
P030025|S098|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/06/2012|||OK30|ADDITION OF NEW SOFTWARE TO INTERFACE WITH THE MANUFACTURING EXECUTION SYSTEM (MES).
P060006|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/06/2012|||OK30|ADDITION OF NEW SOFTWARE TO INTERFACE WITH THE MANUFACTURING EXECUTION SYSTEM (MES).
P060008|S089|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/06/2012|||OK30|ADDITION OF NEW SOFTWARE TO INTERFACE WITH THE MANUFACTURING EXECUTION SYSTEM (MES).
P100023|S044|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/06/2012|||OK30|ADDITION OF NEW SOFTWARE TO INTERFACE WITH THE MANUFACTURING EXECUTION SYSTEM (MES).
P110010|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/06/2012|||OK30|ADDITION OF NEW SOFTWARE TO INTERFACE WITH THE MANUFACTURING EXECUTION SYSTEM (MES).
P060007|S018|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG/ ARCHITECT HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/03/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD USED FOR ANTI-HBS TESTING FOR INCOMING HUMAN PLASMA UNITS.
P110029|S002|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG QUALITATIVE / ARCHITECT HBSAG QUALITATIVE CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/03/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD USED FOR ANTI-HBS TESTING FOR INCOMING HUMAN PLASMA UNITS.
P010032|S055|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON NEUROSTIMULATION SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|10/25/2012|||APPR|APPROVAL FOR THE ADDITION OF STAND-OFF TABS ON THE ROUTED PRINTED CIRCUIT BOARD (PCB), TO CHANGE THE EQUIPMENT USED TO ROUTE THE PCBS, AND TO ADD KAPTON TAPE TO THE BATTERY SURFACE TO PREVENT CONTACT WITH COPPER TRACES FROM THE PCB AND THE ADJACENT SURFACE OF THE BATTERY.
P900056|S116|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/06/2012|||OK30|REMOVAL OF AN IN-PROCESS PULL TEST AND INTRODUCTION OF A START OF SHIFT EQUIPMENT VERIFICATION.
P970003|S149|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|06/20/2012|||OK30|NEW ROUTING FIXTURE IN THE MANUFACTURE OF THE PULSE GENERATOR PRINTED CIRCUIT BOARD ASSEMBLY.
P910001|S057|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 ANTI-REFLECTIVE WINDOW|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2012|07/06/2012|||OK30|ADDITION OF A COMPONENT SUPPLIER FOR THE DEVICE.
P040012|S046|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/06/2012|08/02/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
P060040|S023|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/07/2012|05/07/2013|||APPR|APPROVAL FOR A NEW SYSTEM CONTROLLER FOR THE DEVICE.
P110019|S023|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|06/07/2012|08/06/2012|||APPR|APPROVAL FOR UPDATING LABELING FOR THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO REFLECT A 24 MONTH SHELF LIFE.
P980016|S360|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO ICD, VIRTUOSO II DR/VR ICD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|03/18/2013|||APPR|APPROVAL FOR A CHANGE TO THE INTERFACE USED WITH THE FINAL FUNCTIONAL TESTING EQUIPMENT.
P010031|S313|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO ICD, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2012|03/18/2013|||APPR|APPROVAL FOR A CHANGE TO THE INTERFACE USED WITH THE FINAL FUNCTIONAL TESTING EQUIPMENT.
P030036|S043|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD, MODEL 3830|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/05/2012|||OK30|ADDITIONAL SUPPLIER FOR THE VEIN LIFTER COMPONENT.
P980035|S273|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2012|07/05/2012|||OK30|UPDATES TO THE INTEGRATED CIRCUIT TEST SOLUTION.
P090013|S064|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/05/2012|||OK30|ADDITIONAL SUPPLIER FOR THE VEIN LIFTER COMPONENT.
P830061|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALINE, & VITATRON EXCELLENCE PS+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/05/2012|||OK30|ADDITIONAL SUPPLIER FOR THE VEIN LIFTER COMPONENT.
P850089|S088|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z NOVUS, CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, & IMPULSE II LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/05/2012|||OK30|ADDITIONAL SUPPLIER FOR THE VEIN LIFTER COMPONENT.
P030011|S015|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/08/2012|08/10/2012|||APPR|APPROVAL FOR A CHANGE IN THE PRESSURE LIMIT RANGE FOR THE EXTERNAL AIR PRESSURE REGULATOR OF THE DEVICE.
P890003|S250|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE, CAPSURE MODEL|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/05/2012|||OK30|ADDITIONAL SUPPLIER FOR THE VEIN LIFTER COMPONENT.
P920015|S092|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/05/2012|||OK30|ADDITIONAL SUPPLIER FOR THE VEIN LIFTER COMPONENT.
P930039|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX, CAPSUREFIX NOVUS, SUREFIX, & VITATRON CRYSTALLINE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/05/2012|||OK30|ADDITIONAL SUPPLIER FOR THE VEIN LIFTER COMPONENT.
P980050|S074|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD, MODEL 6937A|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/05/2012|||OK30|ADDITIONAL SUPPLIER FOR THE VEIN LIFTER COMPONENT.
P010068|S028|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS DS, NAVISTAR DS,NAVISTAR RMT DS, EZ STEER NAV DS CATHETERS|OAD|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|04/12/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT  STERIGENICS, S.A., IN VERVIERS, BELGIUM.
P030031|S042|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL CATHETERS|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|04/12/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT  STERIGENICS, S.A., IN VERVIERS, BELGIUM.
P040036|S031|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, EZ STEER THERMOCOOL NAV CATHETERS|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|04/12/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT  STERIGENICS, S.A., IN VERVIERS, BELGIUM.
P950005|S038|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS, CELSIUS RMT, EZ STEER, EZ STEER DS CATHETERS|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|04/12/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT  STERIGENICS, S.A., IN VERVIERS, BELGIUM.
P990025|S032|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|04/12/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT  STERIGENICS, S.A., IN VERVIERS, BELGIUM.
P990071|S018|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SF CATHETERS|LPB|CV|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|04/12/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT  STERIGENICS, S.A., IN VERVIERS, BELGIUM.
P100041|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/08/2012|11/06/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110023|S003|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/06/2012|||OK30|UTILIZE AN UPSIZED FINAL EXPANSION MANDREL.
P980035|S274|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|AUTOMATED ACCELEROMETER TEST SYSTEM UPDATE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2012|07/11/2012|||OK30|CHANGES TO THE AUTOMATED ACCELEROMETER TEST SYSTEM SOFTWARE.
P850079|S053|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2012|07/11/2012|||OK30|ADDITION OF DUPLICATE MICROBIOLOGICAL MANUFACTURING EQUIPMENT.
P010031|S314|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/2012|09/10/2012|||APPR|PROTECTA CRT-D MODEL D334TRG; PROTECTA DF4 CRT-D MODEL 334TRM: PROTECTA XTCRT-D MODEL D314TRG; AND PROTECTA XT DF4 CRT-D MODEL D314TRM.
P080015|S008|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/06/2012|||OK30|CHANGE IN THE CLINICAL DEVELOPMENT DATABASE SOFTWARE FROM VERSION 5.9 TO VERSION 6.0.
P080014|S013|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HUMAN PAPILLOMA VIRUS (HPV)|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/03/2012|||OK30|CHANGE IN THE CLINICAL DEVELOPMENT DATABASE SOFTWARE FROM VERSION 5.9 TO VERSION 6.0.
P040012|S047|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK, RX SELF-EXPANDING CARTOID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/11/2012|||OK30|ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.
P110001|S006|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|HERCULINK ELITE PERIPHERAL STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/11/2012|||OK30|ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.
P040038|S026|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/11/2012|||OK30|ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.
P110019|S024|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/11/2012|||OK30|ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.
P070015|S096|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/11/2012|||OK30|ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.
P100021|S019|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2012|07/11/2012|||OK30|REMOVAL OF A SURFACTANT FROM ONE OF THE STEPS IN GRAFT MANUFACTURING AT THE CONTRACT SUPPLIER.
P050007|S030|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2012|07/11/2012|||OK30|GAS CHANGE FOR A WELDING STEP.
P080006|S041|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2012|07/11/2012|||OK30|UPDATE THE DRUG COMPONENT AND FINISHED LEAD SPECIFICATION OF THE ATTAIN ABILITY FAMILY OF LEADS AND THE ADDITION OF AN ALTERNATE TESTING LABORATORY AN ALTERNATE ANALYTICAL METHODS.
P930031|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|CRITICAL COMPONENT SUPPLIER SITE CHANGE.
P940019|S027|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (IIIAC) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|CRITICAL COMPONENT SUPPLIER SITE CHANGE.
P980033|S021|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|CRITICAL COMPONENT SUPPLIER SITE CHANGE.
P050019|S009|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|WALLSTENT (CAROTID) ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|CRITICAL COMPONENT SUPPLIER SITE CHANGE.
P110035|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|CRITICAL COMPONENT SUPPLIER SITE CHANGE.
P100023|S045|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|PERFORM MANUAL MEASUREMENT OF THE PROXIMAL BALLOON BOND.
P110010|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|PERFORM MANUAL MEASUREMENT OF THE PROXIMAL BALLOON BOND.
P110028|S004|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|CHANGE TO SAMPLE SIZE FOR PYROGEN TESTING.
P110001|S007|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|RX HERCULINK ELITE RENAL STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|CHANGE TO SAMPLE SIZE FOR PYROGEN TESTING.
P040012|S048|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2012|07/11/2012|||OK30|CHANGE TO SAMPLE SIZE FOR PYROGEN TESTING.
P040038|S027|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice||N|06/13/2012|07/11/2012|||OK30|CHANGE TO SAMPLE SIZE FOR PYROGEN TESTING.
P860057|S090|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSHESIS|DYE|CV|30-Day Notice||N|06/13/2012|07/11/2012|||OK30|AN INCREASE IN THE NUMBER OF HEPA FILTERS IN A GOWNING ROOM AND THE ADDITION OF CORRESPONDING HAND DRYERS, AND REMODELING OF A TRANSFER ROOM TO INCLUDE AN EMERGENCY EXIT CORRIDOR AND EMERGENCY EXIT DOOR.
P100041|S012|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice||N|06/13/2012|07/11/2012|||OK30|AN INCREASE IN THE NUMBER OF HEPA FILTERS IN A GOWNING ROOM AND THE ADDITION OF CORRESPONDING HAND DRYERS, AND REMODELING OF A TRANSFER ROOM TO INCLUDE AN EMERGENCY EXIT CORRIDOR AND EMERGENCY EXIT DOOR.
P000007|S032|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice||N|06/13/2012|07/11/2012|||OK30|AN INCREASE IN THE NUMBER OF HEPA FILTERS IN A GOWNING ROOM AND THE ADDITION OF CORRESPONDING HAND DRYERS, AND REMODELING OF A TRANSFER ROOM TO INCLUDE AN EMERGENCY EXIT CORRIDOR AND EMERGENCY EXIT DOOR.
P010041|S034|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice||N|06/13/2012|07/11/2012|||OK30|AN INCREASE IN THE NUMBER OF HEPA FILTERS IN A GOWNING ROOM AND THE ADDITION OF CORRESPONDING HAND DRYERS, AND REMODELING OF A TRANSFER ROOM TO INCLUDE AN EMERGENCY EXIT CORRIDOR AND EMERGENCY EXIT DOOR.
P870077|S045|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice||N|06/13/2012|07/11/2012|||OK30|AN INCREASE IN THE NUMBER OF HEPA FILTERS IN A GOWNING ROOM AND THE ADDITION OF CORRESPONDING HAND DRYERS, AND REMODELING OF A TRANSFER ROOM TO INCLUDE AN EMERGENCY EXIT CORRIDOR AND EMERGENCY EXIT DOOR.
P870056|S050|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice||N|06/13/2012|07/11/2012|||OK30|AN INCREASE IN THE NUMBER OF HEPA FILTERS IN A GOWNING ROOM AND THE ADDITION OF CORRESPONDING HAND DRYERS, AND REMODELING OF A TRANSFER ROOM TO INCLUDE AN EMERGENCY EXIT CORRIDOR AND EMERGENCY EXIT DOOR.
P080003|S001|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Digital breast tomosynthesis|SELENIA DIMENSIONS 3D SYSTEM|OTE|RA|Panel Track|Change Design/Components/Specifications/Material|N|10/09/2012|05/16/2013|13M-0595|05/23/2013|APPR|APPROVAL  FOR THE SELENIA DIMENSIONS 3D SYSTEM.  THIS DEVICE IS INDICATED TO GENERATE DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. THE SELENIA DIMENSIONS (2D OR 3D) SYSTEM IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS A 2D MAMMOGRAPHY SYSTEM FOR SCREENING MAMMOGRAMS. SPECIFICALLY, THE SELENIA DIMENSIONS SYSTEM CAN BE USED TO GENERATE 2D DIGITAL MAMMOGRAMS AND 3D MAMMOGRAMS. EACH SCREENING EXAMINATION MAY CONSIST OF: A 2D FFDM IMAGE SET; OR A 2D AND 3D IMAGE SET, WHERE THE 2D IMAGE CAN BE EITHER A FFDM OR A 2D IMAGE GENERATED FROM THE 3D IMAGE SET. THE SELENIA DIMENSIONS SYSTEM MAY ALSO BE USED FOR ADDITIONAL DIAGNOSTIC WORKUP OF THE BREAST.
P030017|S136|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2012|07/10/2012|||OK30|CLARIFY VISUAL INSPECTION CRITERIA FOR THE PADDLE DISK.
P890003|S251|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DDMA SOFTWARE|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/14/2012|09/12/2012|||APPR|APPROVAL FOR THE USE OF RECENTLY APPROVED SOFTWARE 9995 VERSION 7.4 AND ASSOCIATED DDMA SOFTWARE 2491 WITH RECENTLY APPROVED DEVICE MODELS D264VRM AND D204VRM.
P980016|S361|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/2012|09/10/2012|||APPR|APPROVAL FOR THE PROTECTA ICD MODELS D334DRG, D334VRG; PROTECTA DF4 ICD MODELS D334DRM, D334VRM; PROTECTA XT ICD MODELS 0314DRG, D314VRG; PROTECTA XT DF4 ICD; MODELS D314DRM; AND D314VRM.
P980016|S362|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DF4 ICD, SECURA DF4 ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/14/2012|09/12/2012|||APPR|APPROVAL FOR THE USE OF RECENTLY APPROVED SOFTWARE 9995 VERSION 7.4 AND ASSOCIATED DDMA SOFTWARE 2491 WITH RECENTLY APPROVED DEVICE MODELS D264VRM AND D204VRM.
P980024|S007|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATH VYSION HER-2 DNA PROBE KIT ASSAY|MVD|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2012|12/20/2012|||APPR|APPROVAL FOR THE MANUFACTURING CHANGE TO COMPONENTS OF THE PROBECHEK HER-2/NEU CUTOFF CONTROL SLIDES USED IN THE PATHVYSION HER-2 DNA PROBE KIT.  THE CHANGE INCLUDED CREATION OF A NEW MASTER CELL BANK AND A NEW WORKING CELL BANK FROM SEED STOCK OF HS578T CELLS, USED IN THE MANUFACTURE OF THE PROBECHEK HER-2/NEU CUTOFFCONTROL SLIDES.
P000037|S027|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2012|07/11/2012|||OK30|CHANGE IN RECEIVING ACCEPTANCE TESTING.
P100023|S046|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice||N|06/14/2012|07/11/2012|||OK30|CHANGE TO THE LOCATION OF A CRITICAL COMPONENT SUPPLIER.
P110010|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice||N|06/14/2012|07/11/2012|||OK30|CHANGE TO THE LOCATION OF A CRITICAL COMPONENT SUPPLIER.
P060008|S090|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice||N|06/14/2012|07/11/2012|||OK30|CHANGE TO THE LOCATION OF A CRITICAL COMPONENT SUPPLIER.
P040016|S089|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM (MONORAIL)|MAF|CV|30-Day Notice||N|06/14/2012|07/11/2012|||OK30|CHANGE TO THE LOCATION OF A CRITICAL COMPONENT SUPPLIER.
P950020|S051|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||FLEXTOME CUTTING BALLOON (MONORAIL)||CV|30-Day Notice||N|06/14/2012|07/11/2012|||OK30|CHANGE TO THE LOCATION OF A CRITICAL COMPONENT SUPPLIER.
P910073|S103|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2012|07/13/2012|||OK30|ADD AN ALTERNATE SUPPLIER FOR LEAD COMPONENTS.
P000020|S015|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|STINGER, STINGER S, STINGER M, STINGER SM, SCORPION 2, SCORPION 2M ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2012|07/12/2012|||OK30|ADDITIONAL SUPPLIER OF ELECTRODE EXTENSION CABLES.
P080011|S014|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2012|07/09/2012|||OK30|UPDATE OF SOFTWARE FOR ALL LINES EXCLUDING LINE 11.
P930031|S033|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2012|07/12/2012|||OK30|CHANGE TO THE FIRM¿S ETHYLENE OXIDE STERILIZATION CYCLES.
P940019|S028|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2012|07/12/2012|||OK30|CHANGE TO THE FIRM¿S ETHYLENE OXIDE STERILIZATION CYCLES.
P980033|S022|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2012|07/12/2012|||OK30|CHANGE TO THE FIRM¿S ETHYLENE OXIDE STERILIZATION CYCLES.
P860008|S022|CARDIO COMMAND|4920 WEST CYPRESS ST. STE.110||TAMPA|FL|33607||SYSTEM, ESOPHAGEAL PACING|ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM|LPA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2012|07/18/2012|||OK30|ADDITION OF A NEW PIECE OF EQUIPMENT USED TO CUT AND STRIP PACING WIRES AND SHRINK TUBING.
P990004|S022|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFLO HEMOSTATIC MATRIX|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/18/2012|07/18/2012|||APPR|APPROVAL FOR A CHANGE IN THE WORDING OF THE INDICATION FOR USE STATEMENT.PRIOR IFU: SURGIFLO HEMOSTATIC MATRIX, MIXED WITH STERILE SALINE OR THROMBIN SOLUTION, IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARLERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.  NEW IFU: SURGIFLO HEMOSTATIC MATRIX, MIXED WITH STERILE SALINE OR THROMBIN SOLUTION,IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL METHODS IS INEFFECTIVE OR IMPRACTICAL.
P960004|S052|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2012|07/18/2012|||OK30|ADDITION OF A CURRENT CLEANING STEP.
P950037|S109|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, external pacemaker, dual-chamber|RELIATY / MODEL 3145 PACING SYSTEM|OVJ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/18/2012|08/28/2012|||APPR|APPROVAL FOR FIRMWARE MODIFICATIONS AND LABELING UPDATES TO THE DEVICES.
P990071|S019|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|STOCKERT RADIOFREQUENCY GENERATOR|LPB|CV|30-Day Notice||N|06/19/2012|07/25/2012|||OK30|ALTERNATE SUPPLIER OF THE CONDUCTOR CABLE COMPONENT.
P100049|S003|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2012|01/24/2013|||APPR|APPROVAL FOR A DESIGN CHANGE THAT INCORPORATES A CLASP INTO THE LINX DEVICE.
P950005|S039|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|07/25/2012|||OK30|ALTERNATE SUPPLIER OF THE CONDUCTOR CABLE COMPONENT.
P990025|S033|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|07/25/2012|||OK30|ALTERNATE SUPPLIER OF THE CONDUCTOR CABLE COMPONENT.
P010068|S029|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR/CELSIUS DS CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|07/25/2012|||OK30|ALTERNATE SUPPLIER OF THE CONDUCTOR CABLE COMPONENT.
P100049|S004|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2012|03/07/2013|||APPR|APPROVAL FOR A NEW ESOPHAGUS SIZING TOOL THAT WILL BE USED DURING THE IMPLANT PROCEDURE.
P100013|S004|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|07/20/2012|||OK30|SEVERAL MANUFACTURING CHANGES TO SUPPLIER PROVIDED MOLDED COMPONENTS.
P960004|S053|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE 11 AND THINLINE II|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2012|08/02/2012|||APPR|APPROVAL FOR AN ALTERNATE PRIMER MATERIAL.
P100023|S047|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2012|01/29/2013|||APPR|APPROVAL FOR AN UPDATE TO THE DISTAL WELD INSPECTION CRITERIA FOR ACCEPTABLE BUBBLE SIZE.
P110010|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2012|01/29/2013|||APPR|APPROVAL FOR AN UPDATE TO THE DISTAL WELD INSPECTION CRITERIA FOR ACCEPTABLE BUBBLE SIZE.
P010031|S315|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D|LWS|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/19/2012|01/03/2013|||APPR|APPROVAL TO UPDATE THE DEVICE LABELING WITH THE RESULTS FROM THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) POST-APPROVAL STUDY (PAS).
P980016|S363|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD,INTRINSIC ICD,MARQUIS DR ICD,VR ICD,MAXIMO II ICD,VR ICD,PROTECTA ICD,XT ICD,SECURA ICD,VIRTUOSO ICD|LWS|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/19/2012|01/03/2013|||APPR|APPROVAL TO UPDATE THE DEVICE LABELING WITH THE RESULTS FROM THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) POST-APPROVAL STUDY (PAS).
P910073|S104|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE EZ IS-1 ACTIVE FIZATION LEAD MODELS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|07/12/2012|||OK30|ADDITIONAL SUPPLIER FOR A LEAD TIP COMPONENT.
P960006|S034|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/RETRACTABLE PACING LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2012|07/12/2012|||OK30|ADDITIONAL SUPPLIER FOR A LEAD TIP COMPONENT.
P030036|S044|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD, 3830|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2012|07/18/2012|||OK30|USE OF A NEW PHYSICAL VAPOR DEPOSITION SYSTEM.
P960004|S054|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE/FINELINE LEADS FAMILIES|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2012|10/05/2012|||APPR|APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
P910073|S105|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|ENDOTAK LEAD SYSTEM FAMILY|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2012|10/05/2012|||APPR|APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
P010012|S295|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD, EASYTRAK, LIVIAN, COGNIS, AND ACUITY SPIRAL FAMILIES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2012|10/05/2012|||APPR|APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
P830060|S072|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2012|10/05/2012|||APPR|APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
P930035|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P /P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILIES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2012|10/05/2012|||APPR|APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
P960040|S265|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV AND PRIZM DR/VR, VITALITY, CONFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVERTER DEBRILLAOR (AICD) SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2012|10/05/2012|||APPR|APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
P910077|S122|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) FAMILIES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2012|10/05/2012|||APPR|APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
P030011|S016|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA COMPANION 2 DRIVER SYSTEM|LOZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/21/2012|08/20/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110010|S019|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2012|07/20/2012|||OK30|SOFTWARE AND HARDWARE CHANGES TO THE ETHYLENE OXIDE STERILIZATION CHAMBER 1.
P080011|S015|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COOPERVISION COMFILCON A SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/2012|12/18/2012|||APPR|APPROVAL FOR THE ADDITION OF A NEW PRIVATE LABEL BRAND NAME BREATHABLES XW.
P980024|S008|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATH VYSION HER-2 DNA PROBE KIT ASSAY|MVD|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/21/2012|07/17/2012|||APPR|APPROVAL FOR CHANGES TO PATHVYSION LABELING IN ORDER TO PROVIDE CUSTOMERS WITH CONSISTENT, CURRENT, AND CLEAR INFORMATION.
P960009|S149|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLAMTABLE NEUROSTIMULATORS: ACTIVA RC MODEL 37612, ACTIVA PC MODEL 37601, ACTIVA SC MODEL 37602 AND ACTIVA SC M|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/22/2012|08/24/2012|||APPR|APPROVAL FOR ELIMINATING THE EXTERNAL PARYLENE COATING FROM THEFOLLOWING IMPLANTABLE NEUROSTIMULATORS: ACTIVA RC MODEL 37612, ACTIVA PC MODEL 37601, ACTIVA SC MODEL 37602 AND ACTIVA SC MODEL 37603.
P910001|S058|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2012|07/25/2012|||OK30|ADDITION OF NEW EXTRUSION EQUIPMENT.
P960042|S039|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2012|07/25/2012|||OK30|ADDITION OF NEW EXTRUSION EQUIPMENT.
P030017|S137|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice||N|06/22/2012|07/17/2012|||OK30|USE OF A MODIFIED GROSS LEAD DETECTION METHOD FOR THE IMPLANTABLE PULSE GENERATOR (IPG).
P110010|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLQTINUM CHROMIUM STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/25/2012|08/24/2012|||APPR|APPROVAL OF THE POST-APROVAL STUDY PROTOCOL.
P030017|S138|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice||N|06/25/2012|07/24/2012|||OK30|ALTERNATE QUALIFIED SUPPLIER FOR ELECTRODES AND CONTACTS.
P010014|S035|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/2012|07/19/2012|||APPR|APPROVAL FOR CHANGES TO THE SURGICAL TECHNIQUE MANUAL.
P080011|S016|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINILITY (COMFILCON A) SOFT (HYDROPHYLIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2012|07/17/2012|||OK30|REQUALIFICATION OF MANUFACTURING EQUIPMENT.
P050047|S027|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2012|07/23/2012|||OK30|NEW TEST RELEASE SPECIFICATION FOR JUVÈDERM ULTRA XC AND JUVÈDERM ULTRA PLUS XC 1.0 ML SYRINGES.
P110010|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE)|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/26/2012|08/23/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110016|S003|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/25/2012|07/30/2013|||APPR|APPROVAL FOR  ADDING A MEDIGUIDE TECHNOLOGY PASSIVE SENSOR INTO THE TIP OF THE DEVICE FOR THE PURPOSES OF AIDING NAVIGATION AND  CHANGING THE COOL PATH DUO UNI-DIRECTIONAL (UNI-D) HANDLE TO A COOL PATH DUO BI-DIRECTIONAL (BI-D) HANDLE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COOL PATH DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND SAFIRE DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND ARE INDICATED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. THE CATHETERS ARE INTENDED FOR USE WITH A COMPATIBLE EXTERNAL PUMP AND THE IBI-1500T9-CP RF GENERATOR AT A MAXIMUM OF 50 WATTS. MEDIGUIDE ENABLED ABLATION CATHETERS ARE USED WITH THE MEDIGUIDE TECHNOLOGY TO ENABLE REAL-TIME TIP POSITIONING AND NAVIGATION. THE MEDIGUIDE TECHNOLOGY IS INDICATED FOR USE AS AN ADJUNCT TO FLUOROSCOPY.
P020055|S003|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2012|07/24/2012|||OK30|ADDITION OF A SUPPLIER OF RAW MATERIALS FOR THE IVIEW DETECTION KIT, WHICH IS PART OF THE DEVICE.
P020009|S087|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|07/26/2012|||OK30|SOFTWARE MODIFICATION TO THE BALLOON STRETCHING PROCESS.
P040016|S090|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|07/26/2012|||OK30|SOFTWARE MODIFICATION TO THE BALLOON STRETCHING PROCESS.
P060008|S091|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|07/26/2012|||OK30|SOFTWARE MODIFICATION TO THE BALLOON STRETCHING PROCESS.
P100023|S048|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|07/26/2012|||OK30|SOFTWARE MODIFICATION TO THE BALLOON STRETCHING PROCESS.
P110010|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|07/26/2012|||OK30|SOFTWARE MODIFICATION TO THE BALLOON STRETCHING PROCESS.
P020045|S044|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CRYOABLATION CONSOLE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2012|08/24/2012|||APPR|APPROVAL FOR CHANGES RELATED TO UPDATING FOR COMPLIANCE TO IEC60601-1 3RD EDITION STANDARDS, REMOVAL OF THE FLOPPY DISK DRIVE, AND RELATED LABELING UPDATES.
P100010|S017|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|CRYOABLATION CONSOLE|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2012|08/24/2012|||APPR|APPROVAL FOR CHANGES RELATED TO UPDATING FOR COMPLIANCE TO IEC60601-1 3RD EDITION STANDARDS, REMOVAL OF THE FLOPPY DISK DRIVE, AND RELATED LABELING UPDATES.
P810025|S031|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC/AMVISC PLUS OVDS|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2012|07/27/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE DIRECTIONS FOR USE TO INSTRUCT THE END-USER TO VERIFY THE CONNECTION OF THE CANNULA TO THE SYRINGE LUER.
P030031|S043|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2012|07/23/2012|||OK30|ADDITION OF A PACKAGING COMPONENT.
P110019|S025|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/2012|12/21/2012|||APPR|APPROVAL FOR A NEWLY DESIGNED DELIVERY CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME XIENCE XPEDITION; XIENCE XPEDITION SMALL VESSEL (SV) AND XIENCE XPEDITION LONG LESION (LL) EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <=  32MM) WITH REFERENCE VESSEL DIAMETER OF >=2.25MM TO >=4.25MM.
P040024|S060|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|07/26/2012|||OK30|CHANGE IN THE PARTICLE SIZE PROCESSING (PSR) DURING RESTYLANE L MANUFACTURE.
P970029|S020|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2012|07/26/2012|||APPR|APPROVAL TO ADD A WARNING TO THE OUTER BOX OF THE SOLOGRIP III HANDPIECE.
P110010|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|07/27/2012|||OK30|ADDITION OF THE LISTED DEVICES TO THE APPROVED LIST OF PMAS PROCESSED BY A CONTRACT STERILIZER..
P010020|S024|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER|MIP|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/2012|09/04/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS ACTICON CONTROL PUMP, A COMPONENT OF THE AMS ACTICON NEOSPHINCTER.
P020009|S088|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|09/27/2012|||APPR|MODIFIED CONFIGURATION OF THE CARRIER COIL USED IN PRODUCT PACKAGING.
P040016|S091|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|09/27/2012|||APPR|MODIFIED CONFIGURATION OF THE CARRIER COIL USED IN PRODUCT PACKAGING.
P060006|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2012|09/27/2012|||APPR|MODIFIED CONFIGURATION OF THE CARRIER COIL USED IN PRODUCT PACKAGING.
P020018|S045|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FENESTRATED AAA ENDOVASULAR GRAFT|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2012|07/26/2012|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE FOR THE DEVICE.
P810002|S083|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2012|07/26/2012|||OK30|REMOVAL OF THE LINE SCAN LOT RELEASE TEST.
P000037|S028|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/2012|02/13/2013|||APPR|APPROVAL FOR A MODIFIED AORTIC SEWING CUFF AS AN EXTENSION TO THE LINE OF AVAILABLE VALVES; THE REQUEST APPLIED TO THE AORTIC SIZES OF 19, 21, 23, 25, AND 27/29 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ON-X AORTIC PROSTHETIC HEART VALVE WITH ANATOMIC SEWING RING, AND WILL BE GIVEN THE MODEL DESIGNATIONS OF ONXAN (STANDARD VALVE HOLDER) AND ONXANE (EXTENDED VALVE HOLDER).
P080030|S001|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2012|11/15/2012|||APPR|APPROVAL OF THE SHELF-LIFE EXTENSION FOR TWO LOTS OF DURAFLO COATING MATERIAL USED IN THE DEVICE.
P000036|S013|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2012|07/23/2012|||OK30|USAGE OF TWO ADDITIONAL VACUUM SEALERS DURING THE PACKAGING PROCESS.
P810025|S032|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2012|07/27/2012|||OK30|CHANGE TO USE AN AUTOMATED ASSEMBLY, INSPECTION AND PACKAGING SYSTEM DURING MANUFACTURING.
P980035|S276|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ENRHYTHM IPG|NVZ|CV|30-Day Notice||N|06/29/2012|07/26/2012|||OK30|ADDITION OF AN IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO.
P010015|S165|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice||N|06/29/2012|07/26/2012|||OK30|ADDITION OF AN IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO.
P090013|S065|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice||N|06/29/2012|07/26/2012|||OK30|ADDITION OF AN IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO.
P110013|S004|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2012|07/25/2012|||OK30|REMOVAL OF A FINISHED DEVICE INSPECTION STEP.
P980035|S275|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2012|07/25/2012|||APPR|APPROVAL FOR AN UPDATE TO THE L409 INTEGRATED CIRCUIT.
P010015|S164|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA AND SYNCRA CRT-PS|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2012|07/25/2012|||APPR|APPROVAL FOR AN UPDATE TO THE L409 INTEGRATED CIRCUIT.
P010031|S316|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II CRT-D & VARIOUS FAMILIES OF MAXIMO II & PROTECTA CRT-DS' VARIOUS FAMILIES OF CONSULTA ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2012|07/25/2012|||APPR|APPROVAL FOR AN UPDATE TO THE L409 INTEGRATED CIRCUIT.
P980016|S364|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO II DR/VR ICD & VARIOUS FAMILIES OF MAXIMO II, PROTECTA & SECURA ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2012|07/25/2012|||APPR|APPROVAL FOR AN UPDATE TO THE L409 INTEGRATED CIRCUIT.
P960043|S080|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/2012|04/15/2013|13M-0464|05/07/2013|APPR|APPROVAL FOR THE PERCLOSE® PROGLIDE¿ SUTURE MEDIATED CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTSWHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21 F SHEATHS; FOR SHEATH SIZES GREATER THAN 8F, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE AREREQUIRED.
P810031|S045|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELEASTIC DEVICES (OVD) HEALON, HEALON GV AND HEALON5|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|08/09/2012|||OK30|REPLACEMENT OF AN AUTOCLAVE.
P840001|S218|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR 37712, RESTORESENSOR IMPLANTABLE NEUROSTIMULATOR 37714|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|08/01/2012|||OK30|A CHANGE TO THE FINAL FUNCTIONAL TEST.
P960009|S150|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA RC IMPLANTABLE NEUROSTIMULAOR 37612|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|08/01/2012|||OK30|A CHANGE TO THE FINAL FUNCTIONAL TEST.
P110013|S005|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/2012|02/22/2013|13M-0343|03/22/2013|APPR|APPROVAL FOR THE RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETERS IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITHSYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS OF LENGTH <= 35 MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS OF  2.25 MM TO 4.2 MM.
P050023|S054|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|KRONOS LV-T & VARIOUS FAMILIES OF LUMAX HF CRT-D's; VARIOUS FAMILIES OF LUMAX DR & VR ICD's|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2012|08/08/2012|||APPR|APPROVAL FOR UPDATED SOFTWARE VERSION PSW 1202.U.
P980016|S365|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO ICD, CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA DF-DF-4, PROTECTA XT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|08/01/2012|||OK30|CHANGES TO THE RADIO FREQUENCY DEVICE TEST APPLICATION.
P010031|S317|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||MAXIMO II DF-4, MAXIMO II, DF-4, PROTECTA DF-4, PROTECTA ICD, PROTECTA XT DF-4, PROTECTA  XT ICD, SECURA DF-4, SECURA IC||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|08/01/2012|||OK30|CHANGES TO THE RADIO FREQUENCY DEVICE TEST APPLICATION.
P030031|S044|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL, D-1266-XX, CELSIUS RMT THERMOCOOL D-1302 XX|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|07/01/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., IN CHIHUAHUA, MEXICO.
P040036|S032|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT THERMOCOOL CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|07/01/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOSENSE WEBSTER, INC., IN CHIHUAHUA, MEXICO.
P910001|S059|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2012|04/04/2013|||APPR|APPROVAL FOR A CHANGE TO AN ADHESIVE PRIMER USED IN THE MANUFACTURE OF THE ELCA ECCENTRIC (ELL) DEVICES. PREVIOUSLY, YOU HAVE USED LOCTITE 793 WHICH HAS BEEN DISCONTINUED BY THE VENDOR.  THE PRIMER HAS BEEN CHANGED TO LOCTITE 7701, A MEDICAL GRADE ADHESIVE PRIMER USED FOR THE SAME PURPOSE.
P910001|S060|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|07/31/2012|||OK30|CHANGES TO THE ON-DEMAND LABEL PRINTING SYSTEM.
P960042|S040|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|07/31/2012|||OK30|CHANGES TO THE ON-DEMAND LABEL PRINTING SYSTEM.
P060030|S027|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0|MZP|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2012|02/14/2013|||APPR|APPROVAL FOR DEVICE DESIGN MODIFICATIONS TO REDUCE THE SAMPLE INPUT VOLUME, IMPROVE GENOTYPE INCLUSIVITY, AND IMPROVE ASSAY SENSITIVITY TO 15 IU/ML. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST, V2.0 AND IS INDICATED FOR:  THE COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST, V2.0 IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA GENOTYPES 1 TO 6 IN HUMAN EDTA PLASMA OR SERUM OF HCV-INFECTED INDIVIDUALS USING THE COBAS® AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THE COBAS® TAQMAN® ANALYZER OR THE COBAS® TAQMAN® 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE TEST IS INTENDED FOR USE INTHE MANAGEMENT OF PATIENTS WITH CHRONIC HCV IN CONJUNCTION WITH CLINICAL AND LABORATORY MARKERS OF INFECTION. THE TEST CAN BE USED TO PREDICT THE PROBABILITY OF SUSTAINED VIROLOGIC RESPONSE (SVR) EARLY DURING A COURSE OF ANTIVIRAL THERAPY, AND TO ASSESS VIRAL RESPONSE TO ANTIVIRAL TREATMENT (RESPONSE GUIDED THERAPY) AS MEASURED BY CHANGES OF HCV RNA LEVELS IN SERUM OR EDTA PLASMA.  ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAY'S PREDICTIVE VALUE WHEN OTHER THERAPIES ARE USED. ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED.  THE COBAS® AMPLIPREP/ COBAS® TAQMAN® HCV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HCV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HCV INFECTION.
P090016|S002|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALENCE DERMAL FILLER|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/2012|08/10/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE BELOTERO BALANCE INSTRUCTIONS FOR USE TO INCLUDE 27 GAUGE NEEDLES AS AN OPTION FOR INJECTION.
P970003|S150|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|07/26/2012|||OK30|UPDATES TO THE ELECTRICAL TEST SYSTEM SOFTWARE FOR VARIOUS MODELS OF THE VNS THERAPY SYSTEM PULSE GENERATORS.
P860047|S026|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|07/31/2012|||OK30|CHANGE TO USE AN AUTOMATED ASSEMBLY, INSPECTION AND PACKAGING SYSTEM DURING MANUFACTURING.
P010032|S056|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|CHARGING ANTENNA AND PORTABLE CHARGER ANTENNA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|08/01/2012|||OK30|CHANGE TO THE IN-PROCESS AND FINAL INSPECTION IMPEDANCE TEST.
P840001|S219|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/03/2012|03/20/2013|||APPR|APPROVAL FOR OF THE MEDTRONIC SURESCANTM MRI IMPLANTABLE NEUROSTIMULATION SYSTEM, WHICH CONSISTS OF THE PRIMEADVANCED SURESCAN¿ MRI IPG MODEL 97702; RESTOREULTRA SURESCAN¿ MRI IPG MODEL 97712; RESTOREADVANCED SURESCAN¿ MRI IPG MODEL 97713;RESTORESENSOR SURESCAN¿ MRI IPG MODEL 97714; VECTRIS SURESCANTM MRI 1X8 SUBCOMPACT LEADS MODELS 977A160, 977A175, AND 977A190; VECTRIS SURESCANTM MRI 1X8 COMPACT LEADS MODELS 977A260, 977A275, AND 977A290; VECTRIS 1X8 SUBCOMPACT TRIALING LEAD MODEL977D160; VECTRIS 1X8 COMPACT TRIALING LEAD MODEL 977D260; PATIENT PROGRAMMER MODEL 97740; PATIENT RECHARGER KIT MODEL 97754; N¿VISION APPLICATION CARD, VERSION AAP01 MODEL 8870; CLINICIAN PROGRAMMER MODEL 8840; EXTERNAL ANTENNA MODEL 37092; EXTERNALNEUROSTIMULATOR MODEL 37022; AND EXTERNAL NEUROSTIMULATOR MODEL 37021. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC SURESCAN¿ MRI IMPLANTABLE NEUROSTIMULATION SYSTEM AND IS INDICATED AS FOLLOWS.THE MEDTRONIC SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITHTHE FOLLOWING:1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK;2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILEDBACK SYNDROME;3) POST LAMMECTOMY PAIN;4) UNSUCCESSFUL DISK SURGERY;5) DEGENERATIVE DISK DISEASE (DDD)/ HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS;6)PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS;8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS;9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK OPERATIONS.
P110020|S004|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2012|11/19/2012|||APPR|APPROVAL FOR CHANGES TO THE CPU COMPONENT OF THE COBAS Z480 ANALYZER.
P100020|S005|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2012|11/19/2012|||APPR|APPROVAL FOR CHANGES TO THE CPU COMPONENT OF THE COBAS Z480 ANALYZER.
P020009|S089|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS /EXPRESS MONORAIL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|07/25/2012|||OK30|ADDITION OF A COOLING FIXTURE TO THE HOT JAW PROCESS.
P040016|S092|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) MONORAIL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|07/25/2012|||OK30|ADDITION OF A COOLING FIXTURE TO THE HOT JAW PROCESS.
P060008|S092|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2012|07/25/2012|||OK30|ADDITION OF A COOLING FIXTURE TO THE HOT JAW PROCESS.
P010014|S036|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PATIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/02/2012|08/02/2012|||APPR|APPROVAL FOR UPDATES TO THE PACKAGE INSERT WHICH INCLUDED THE FOLLOWING:  STRENGTHENING AND CLARIFICATION OF THE IMPORTANCE OF FOLLOWING THE SURGICAL TECHNIQUE, ADDITIONAL WORDING TO CLARIFY A PRECAUTION TO THE END USER, EXPANDED LANGUAGE FOR A POSSIBLE ADVERSE EVENT ABOUT FOREIGN MATERIAL SENSITIVITY AND REFORMATTING OF THE MAGNETIC RESONANCE (MR) SECTION.
P920015|S093|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 5019 HIGH VOLTAGE (HV) SPLITTER/ADAPTOR KIT|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2012|02/13/2013|||APPR|APPROVAL FOR THE MODEL 5019 HIGH VOLTAGE SPLITTER/ ADAPTOR KIT.
P980035|S277|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/2012|01/15/2013|||APPR|APPROVAL OF AN MR-CONDITIONAL SYSTEM PERMITTING IMPLANTED PATIENTS TO UNDERGO MRI SCANS PROVIDED SPECIFIED CONDITIONS ARE MET.  THE DEVICES, AS MODIFIED, MAKE UP THE ADVISA DR MRI SURESCAN SYSTEM AND WILL BE MARKETED UNDER THE TRADE NAMES ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR WITH SOFTWARE MODEL 9995, CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A AND DDMA MODEL 2491.  THE ADVISA DR MRI SURESCAN SYSTEM IS INDICATED FOR THE FOLLOWING:  1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY; AND2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE:A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND-OR THIRD-DEGREE A VBLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED A V CONDUCTION DISORDERS D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. THE DEVICE IS ALSO INDICATED FOR DUAL CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE:1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TOCARDIAC OUTPUT; AND 2) VVI INTOLERANCE (FOR EXAMPLE, PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHMANTITACHYCARDIA PACING (A TP) IS INDICATED FOR TERMINATION OF ATRIALTACHYARRHYTHMIAS IN BRADYCARDIA PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P890003|S252|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/2012|01/15/2013|||APPR|APPROVAL OF AN MR-CONDITIONAL SYSTEM PERMITTING IMPLANTED PATIENTS TO UNDERGO MRI SCANS PROVIDED SPECIFIED CONDITIONS ARE MET.  THE DEVICES, AS MODIFIED, MAKE UP THE ADVISA DR MRI SURESCAN SYSTEM AND WILL BE MARKETED UNDER THE TRADE NAMES ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR WITH SOFTWARE MODEL 9995, CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A AND DDMA MODEL 2491.  THE ADVISA DR MRI SURESCAN SYSTEM IS INDICATED FOR THE FOLLOWING:  1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY; AND2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE:  A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND-OR THIRD-DEGREE A V BLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK;C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITHOR WITHOUT ASSOCIATED A V CONDUCTION DISORDERS D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES THE DEVICE IS ALSO INDICATED FOR DUAL CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE:1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TOCARDIAC OUTPUT; AND 2) VVI INTOLERANCE (FOR EXAMPLE, PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHMANTITACHYCARDIA PACING (A TP) IS INDICATED FOR TERMINATION OF ATRIALTACHYARRHYTHMIAS IN BRADYCARDIA PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
P950037|S110|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS FAMILIES OF ACTROS, AXIOS, 8A03, CYLOS, DROMOS, KAIROS, PHILOS, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, & ESTELLA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2012|08/08/2012|||APPR|APPROVAL FOR UPDATED SOFTWARE VERSION PSW 1202.U.
P000009|S050|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS AND LEXOS DR/DR-T/VR-T, LUMOS DR/VR-T, XELOS DR-T ICD'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2012|08/08/2012|||APPR|APPROVAL FOR UPDATED SOFTWARE VERSION PSW 1202.U.
P070008|S033|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2012|08/08/2012|||APPR|APPROVAL FOR UPDATED SOFTWARE VERSION PSW 1202.U.
P950009|S016|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT SLIDE PROFILER|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2012|08/30/2012|||APPR|APPROVAL FOR CHANGE OF THE SCAN CONTROLLER BOARD FOR THE DEVICE.
P090003|S013|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2012|08/03/2012|||OK30|CHANGE TO THE AERATION CYCLE TIME FOR THE 40C ETHYLENE OXIDE STERILIZATION CYCLE.
P950029|S069|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|PACEMAKERS, REPLY SR AND DR, ESPIRIT SR AND DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2012|07/30/2012|||OK30|MOVED COMPONENT ASSEMBLY STEP, REMOVAL OF AN OPTIONAL CLEANING STEP AND ALTERNATIVE COMPONENT ATTACHMENT INSPECTION EQUIPMENT.
P980049|S075|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ICD/CRT PARADYM R AND DR, PARADYM CRT-D, PARADYM RF-VR AND DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2012|07/30/2012|||OK30|MOVED COMPONENT ASSEMBLY STEP, REMOVAL OF AN OPTIONAL CLEANING STEP AND ALTERNATIVE COMPONENT ATTACHMENT INSPECTION EQUIPMENT.
P060027|S043|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2012|07/30/2012|||OK30|MOVED COMPONENT ASSEMBLY STEP, REMOVAL OF AN OPTIONAL CLEANING STEP AND ALTERNATIVE COMPONENT ATTACHMENT INSPECTION EQUIPMENT.
P890047|S039|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice||N|07/03/2012|07/23/2012|||OK30|ALTERNATE COMPONENT SUPPLIER.
P840064|S051|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice||N|07/03/2012|07/23/2012|||OK30|ALTERNATE COMPONENT SUPPLIER.
P010020|S025|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|08/02/2012|||OK30|CHANGE IN THE LABEL DATABASE SERVER AND A LABELING SOFTWARE REVISION TO THE NICELABEL SYSTEM.
P000053|S044|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|08/02/2012|||OK30|CHANGE IN THE LABEL DATABASE SERVER AND A LABELING SOFTWARE REVISION TO THE NICELABEL SYSTEM.
P920023|S031|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT|AMS UROLUME ENDOPROSTHESIS|MES|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|08/02/2012|||OK30|CHANGE IN THE LABEL DATABASE SERVER AND A LABELING SOFTWARE REVISION TO THE NICELABEL SYSTEM.
P050042|S017|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2012|07/31/2012|||OK30|CHANGE TO USE NEW CONTAINERS FOR MANUFACTURING OF MICROPARTICLE BASEDCOMPONENTS AND IMPLEMENTING A NEW TEST TO VERIFY THE EFFECTIVENESS OF THE PREVENTIVE ACTION.
P820021|S034|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|VIFILCON A SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2012|07/30/2012|||OK30|CHANGE IN RAW MATERIAL TEST METHOD.
P050012|S048|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2012|08/03/2012|||OK30|ADDITION OF AN ALTERNATIVE COMPONENT SUPPLIER. ACTIMED, FOR THE PUSHROD AND CANNULA COMPONENTS OF THE SENSOR APPLICATOR OF THE DEVICE.
P040002|S038|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2012|08/22/2012|||APPR|APPROVAL FOR STAND-ALONE DELIVERY SYSTEM FOR THE STRAIGHT AND TAPERED LIMB EXTENSION STENT GRAFTS AND FOR THE FLARED LIMB EXTENSIONS GRAFTS.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM AS AN ACCESSORY TO THE AFX AAA ENDOVASCULAR SYSTEM WHICH IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA.
P040002|S039|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track||N|07/05/2012|04/16/2013|||APPR|APPROVAL FOR THE ADDITION OF BILATERAL PERCUTANEOUS ACCESS TO THE DEVICE LABELING.
P010032|S057|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON IMPLANTABLE PULSE GENERATOR|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2012|08/24/2012|||APPR|APPROVAL FOR A CHANGE TO THE INTERNAL BATTERY HOUSING MATERIAL FROM TITANIUM TO 304L STAINLESS STEEL.
N18033|S066|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2012|07/30/2012|||OK30|ADDITION OF AN AUTOMATED QUALITY CONTROL INSPECTION STEP.
P040045|S033|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2012|07/30/2012|||OK30|ADDITION OF AN AUTOMATED QUALITY CONTROL INSPECTION STEP.
P950029|S070|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPIRIT PACEMAKER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2012|07/31/2012|||OK30|UPDATE TO THE THERMOSEALING PROCESS.
P980049|S076|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM AND PARADYM RF ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR)|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2012|07/31/2012|||OK30|UPDATE TO THE THERMOSEALING PROCESS.
P060027|S044|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT-D (CARDIACRESYNCHRONIZATION THERAPY DEFIBRILLATOR)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2012|07/31/2012|||OK30|UPDATE TO THE THERMOSEALING PROCESS.
P010012|S296|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA, COGNIS, LIVIAN|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2012|11/14/2012|||APPR|APPROVAL FOR THE ADDITION OF AN AUTOMATED VISION SYSTEM DURING SEAL PLUG INSPECTION.
P960040|S266|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA, TELIGEN, CONFIENT|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2012|11/14/2012|||APPR|APPROVAL FOR THE ADDITION OF AN AUTOMATED VISION SYSTEM DURING SEAL PLUG INSPECTION.
P030005|S085|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2012|11/14/2012|||APPR|APPROVAL FOR THE ADDITION OF AN AUTOMATED VISION SYSTEM DURING SEAL PLUG INSPECTION.
P030005|S086|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CRT-P AND ZOOMVIEW PROGRAMMER|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2012|08/29/2012|||APPR|APPROVAL FOR MODEL 2869 ZOOMVIEW PROGRAMMER SOFTWARE APPLICATION V1.08
P010031|S318|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VIVA XT CRT-D, VIVA S CRT-D, BRAVA CRT-D, VIVA/BRAVA/EVERA SOFTWARE APPLICATION|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2012|01/29/2013|||APPR|APPROVAL FOR THE VIVA/BRAVA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION (CRT-D).
P890003|S253|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Programmer, pacemaker|MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS|KRG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2012|01/29/2013|||APPR|APPROVAL FOR THE VIVA/BRAVA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION (CRT-D).
P080030|S002|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2012|11/08/2012|||APPR|MODIFICATIONS TO THE DESIGN OF THE OUTER BLISTER TRAY USED FOR DEVICE PACKAGING.
P040024|S061|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2012|08/10/2012|||OK30|TRANSFER OF LABORATORY TESTING EQUIPMENT TO THE NEWLY CONSTRUCTED QUALITY CONTROL LABORATORY TESTING SITE WITHIN THE  Q-MED FACILITY.
P010019|S033|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2012|08/09/2012|||OK30|IMPROVED MEASUREMENT ON THE PARTICLE SIZE OF A COMPONENT.
P060019|S022|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/10/2012|09/07/2012|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE BOND BETWEEN THAT CATHETER SHAFT AND THE EXTENSION TUBING.  SPECIFICALLY, YOU PROPOSE TO CHANGE THE ADHESIVE FROM LOCTITE TO URETHANE AND TO MODIFY THE CONTACT HOLE FROM A CIRCULAR TO AN OCTAGONAL SHAPE.
P110016|S004|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH DUO ABLATION CATHETER|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/10/2012|09/07/2012|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE BOND BETWEEN THAT CATHETER SHAFT AND THE EXTENSION TUBING.  SPECIFICALLY, YOU PROPOSE TO CHANGE THE ADHESIVE FROM LOCTITE TO URETHANE AND TO MODIFY THE CONTACT HOLE FROM A CIRCULAR TO AN OCTAGONAL SHAPE.
P060038|S014|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2012|07/25/2012|||OK30|ADDITIONAL BOVINE PERICARDIUM TISSUE SUPPLIER.
P030054|S225|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MERLIN PATIENT CARE SYSTEM ACCESSORIES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2012|08/08/2012|||OK30|ALTERNATE SUPPLIER FOR ECG CABLES.
P030054|S226|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ATLAS + HF/QUANDRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2012|04/10/2014|||APPR|APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
P040005|S008|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 FISH PHARMDX KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2012|07/31/2012|||OK30|MANUFACTURING PROCESS OF PNA OLIGOMERS IN THE DEVICE.
P910023|S297|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2012|04/10/2014|||APPR|APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
P880086|S220|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2012|04/10/2014|||APPR|APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
P030035|S098|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'S|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2012|04/10/2014|||APPR|APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
P880006|S081|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2012|04/10/2014|||APPR|APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
P970013|S050|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|MICRONY FAMILY OF PACEMAKERS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2012|04/10/2014|||APPR|APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
P100024|S002|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2012|07/31/2012|||OK30|MANUFACTURING PROCESS OF PNA OLIGOMERS IN THE DEVICE.
P060019|S023|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE BLU AND THERAPY COOL BI-DIRECTIONAL ABLATION CATHETERS|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2012|11/29/2012|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF THE CATHETER SHAFT SUBASSEMBLY.
P110016|S005|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE BLU DUO ABLATION CATHETERS|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2012|11/29/2012|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF THE CATHETER SHAFT SUBASSEMBLY.
P100041|S013|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN THRANSCATHETER HEART VALVE (THV)|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2012|08/09/2012|||OK30|UPGRADE TO BRAIDING EQUIPMENT AND REMOVAL OF SURFACTANT FOR A MANUFACTURING PROCESS.
P980035|S278|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/ENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2012|08/10/2012|||OK30|UPDATES TO THE PROTEUS DEVICE TEST SYSTEM SOFTWARE.
P880086|S221|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT FAMILY OF DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2012|09/06/2012|||APPR|APPROVAL FOR AN UPDATE TO THE PACE AND SENSE INTEGRATED CIRCUIT.
P030035|S099|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM FAMILY OF DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2012|09/06/2012|||APPR|APPROVAL FOR AN UPDATE TO THE PACE AND SENSE INTEGRATED CIRCUIT.
P960009|S151|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA RC IMPLANTABLE NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|08/10/2012|||OK30|ADDITION OF A DUPLICATE ETO STERILIZATION SYSTEM.
P970004|S137|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|08/10/2012|||OK30|ADDITION OF A DUPLICATE ETO STERILIZATION SYSTEM.
P080025|S034|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|08/10/2012|||OK30|ADDITION OF A DUPLICATE ETO STERILIZATION SYSTEM.
P840001|S220|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3 AND 4, SYNERGY, SYNERGY VERSITREL SPINAL CORD STIMULATION SYSTEM;RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|08/10/2012|||OK30|ADDITION OF A DUPLICATE ETO STERILIZATION SYSTEM.
P980022|S119|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK REAL-TIME SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/2012|12/26/2013|||APPR|APPROVAL FOR A NEW WATERTIGHT TESTER ACCESSORY DEVICE AS WELL AS LABELINGCHANGES RELATED TO NEW CLEANING AND DISINFECTION PROTOCOLS FOR THE MINILINK TRANSMITTER AND NEW WATERTIGHT TESTER. THE MINILINK TRANSMITTER (MODEL MMT-7703) AND THE WATERTIGHT TESTER (MODEL MMT-7726) ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REALTIME SYSTEM, AND MINI LINK REAL-TIME SYSTEM.
P010047|S021|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2012|09/05/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE PUSH ROD (C-00286), END CAP(C-00280) AND OUTER HOUSING (C-00279) COMPONENTS OF THE APPLICATOR KIT AND ASSOCIATED MINOR LABELING CHANGES.
P040016|S093|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|11/05/2012|||APPR|APPROVAL FOR USE OF AN ALTERNATE CLEANING PROCEDURE.
P060006|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|11/05/2012|||APPR|APPROVAL FOR USE OF AN ALTERNATE CLEANING PROCEDURE.
P090003|S014|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD MONORAIL ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|11/05/2012|||APPR|APPROVAL FOR USE OF AN ALTERNATE CLEANING PROCEDURE.
P060008|S093|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|11/05/2012|||APPR|APPROVAL FOR USE OF AN ALTERNATE CLEANING PROCEDURE.
P930039|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEADS|NVY|CV|30-Day Notice||N|07/13/2012|08/06/2012|||OK30|ALTERNATE SUPPLIERS OF MOLDED SILICONE COMPONENTS.
P980035|S279|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, SIGMA DR IPG, SIGMA S IPG|NVZ|CV|30-Day Notice||N|07/13/2012|08/06/2012|||OK30|ALTERNATE SUPPLIERS OF MOLDED SILICONE COMPONENTS.
P030036|S045|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice||N|07/13/2012|08/06/2012|||OK30|ALTERNATE SUPPLIERS OF MOLDED SILICONE COMPONENTS.
P040024|S062|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE L AND PERLANE L INJECTABLE GEL|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2012|08/06/2012|||APPR|APPROVAL FOR AN EXTENSION TO THE EXPIRATION DATE OF THE RESTYLANE L AND PERLANE L INJECTABLE GELS (0.5 AND 1.0 ML) FROM 24 MONTHS TO 36 MONTHS.
P970051|S091|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/2012|05/28/2013|||APPR|APPROVAL FOR THE AQUA ACCESSORY FOR THE NUCLEUS COCHLEAR IMPLANT SYSTEM. THE AQUA ACCESSORY IS A WATER RESISTANT POUCH THAT IS SEALABLE AT ONE END, AND HOLDS THE EXTERNAL NUCLEUS 5 CP810 SOUND PROCESSOR AND COIL. IT MAY BE USED FOR UP TO AN HOUR TO KEEP THE EXTERNAL COMPONENTS DRY DURING USE IN WATER (E.G., SWIMMING). THE AQUA ACCESSORY IS INTENDED FOR UNILATERAL OR BILATERAL USE BY COCHLEAR IMPLANT RECIPIENTS WHO HAVE THE ABILITY TO NOTIFY A CAREGIVER OR THE ABILITY TO REMOVE THE DEVICE ON THEIR OWN, IF THE DEVICE BECOMES HOT OR IF THERE IS A CHANGE IN SOUND QUALITY.
P060037|S018|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|08/10/2012|||OK30|CHANGE IN PACKAGE HEAT SEALING PROCESS PARAMETERS FOR THE INNER POUCH.
P030052|S009|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT ASSAY|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2012|08/10/2012|||OK30|ELIMINATE A SECOND CLONE IDENTITY TESTING PROCEDURE AT THE FERMENTATION STAGE FOR LSI 9P21, QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEADMIXING SYSTEM AND VALIDATION OF MIXING PROCESS IN THE MANUFACTURE OF HYBRIDIZATION BUFFER,IMPLEMENT THE OPTICAL DENSITY READING AS AN ADDITIONAL IN PROCESS QUALITY CONTROL, VALIDATE ANEXISTING MIXING PROCESS FOR THE UROVYSION BULK SOLUTION, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
P030017|S139|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECIOUS SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2012|08/15/2012|||OK30|ALLOW CABLE ABLATION TO BE PROCESSED IN-HOUSE.
P890055|S043|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|08/14/2012|10/16/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE PROGRAMMABLE INFUSION SYSTEM.  THIS MODIFICATION CONSISTED OF REMOVAL OF THE EPOXY USED ON THE WIRES OF THE ACTUATOR COMPONENT OF THE PUMP.
P100023|S049|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2012|09/17/2012|||OK30|CHANGES TO THE DISTAL BOND PROCESS FOR THE STENT DELIVERY SYSTEM.
P840001|S221|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION EXTENSION MODELS 37081, 37082 AND 37083|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/2012|09/14/2012|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE PACKAGE DIMENSIONS, THE INNER TRAY AND THE RETAINER LID. ALSO REQUESTED WAS A PACKAGE MATERIAL CHANGE FROM POLYVINYL CHLORIDE (PVC) TO POLYETHYLENE TEREPHTHALATE GLYCOL (PETG) FOR THE OUTER TRAY, THE INNER TRAY AND THE RETAINER LID.
P110010|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2012|09/17/2012|||OK30|CHANGES TO THE DISTAL BOND PROCESS FOR THE STENT DELIVERY SYSTEM.
P100013|S005|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2012|08/14/2012|||OK30|IMPLEMENTATION CHANGES TO THE POUCH SEALING PROCESS.
P010014|S037|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2012|08/15/2012|||OK30|CHANGES TO THE DEVICE STERILE PACKAGING.
P010032|S058|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI IPG NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/2012|09/14/2012|||APPR|APPROVAL FOR THE MODIFICATION TO THE MODEL 3721 EON MINI CHARGINGSYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 3720 EON MINI LE CHARGER AND MODEL 3722 EON MINI LE CHARGING SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND CHRONIC LOW BACK/LEG PAIN.
P980035|S280|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA 900 (MODEL 9988 V8.0). ADAPTA, VERSA, SENSIA (MODEL SW003 V8.0), RELIA (MODEL SW010 V8.0), ENPULSE (MODEL 9981 V8.|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/2012|03/13/2013|||APPR|APPROVAL FOR THE KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPA 900, ADAPTA, SENSIA, RELIA, ENPULSE, ENRHYTHM, ADVISA, VERSA AND SIGMA.
P010030|S035|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/17/2012|08/15/2012|||APPR|APPROVAL FOR MINOR HARDWARE UPDATES TO LEAD-FREE COMPONENTS FOR THE DEVICE.
P010015|S166|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC III (MODEL 9981 V8.0)|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/2012|03/13/2013|||APPR|APPROVAL FOR  THE INSYNC III, CONSULTA CRT-P, SYNCRA CRT-P.
P010031|S319|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONSULTA CRT-P, ADVISA (MODEL 9995 V8.0) CONSULTA CRT-D, SECURA (MODEL 9995 V8.0) INSYNC III, MAXIMO II, CONCERTO II|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/2012|03/13/2013|||APPR|APPROVAL FOR THE KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPA 900, ADAPTA, SENSIA, RELIA, ENPULSE, ENRHYTHM, ADVISA, VERSA AND SIGMA.
P990001|S105|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VISTATRON C&T SERIES (MODEL VSF04 V8.0, MODEL VSF 12 V8.0, MODEL VSF08 V8.0)|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/2012|03/13/2013|||APPR|APPROVAL FOR THE VITATRON DESKTOP SOFTWARE APPLICATION.
P980016|S366|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO, VIRTUOSO (MODEL SW002 V8.0)|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/2012|03/13/2013|||APPR|APPROVAL FOR THE VIRTUOSO II, MAXIMO II, SECURA DF4, SECURA, ENTRUST AND VIRTUOSO.
P010032|S059|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON NEUROSTIMULATION SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2012|01/09/2013|||APPR|APPROVAL THE  REVISION TO THE MANUFACTURING PROCESS FOR EON MINI (MODEL 3788) IMPLANTABLE PULSE GENERATOR HEADERS.
P890003|S254|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DEVICE CARELINK ENCORE 29901 PROGRAMMER INCLUDING ACCESSORIES AND REVEAL DX, REVEAL XT (MODEL SW007 V8.0)|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/17/2012|03/13/2013|||APPR|
P100023|S050|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2012|08/14/2012|||OK30|CHANGES TO THE INSPECTION MANDREL VERIFICATION PROCESS.
P110010|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2012|08/14/2012|||OK30|CHANGES TO THE INSPECTION MANDREL VERIFICATION PROCESS.
P980016|S367|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice||N|07/18/2012|08/10/2012|||OK30|UPDATES TO THE NEXT GENERATION HYBRID TESTER SOFTWARE.
P010031|S320|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2012|08/10/2012|||OK30|UPDATES TO THE NEXT GENERATION HYBRID TESTER SOFTWARE.
P090013|S066|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2012|08/14/2012|||OK30|ADDITIONAL LASER WELDER TO PERFORM THE LASER WELD PROCESS OF THE CONNECTOR PIN TO THE COIL.
P930039|S070|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2012|08/15/2012|||OK30|CHANGES TO THE LASER WELD PARAMETERS USED FOR THE CONNECTOR PIN TO COIL LASER WELD PROCESS.
P910023|S298|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|SJM ELLIPSE AND FORTIFY ASSURA ICDS|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2012|09/06/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERATIONS MALAYSIA (SJM-MYPE) IN PENANG, MALAYSIA.
P030054|S227|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SJM QUADRA ASSURA AND UNIFY ASSURA CRTDS|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2012|09/06/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERATIONS MALAYSIA (SJM-MYPE) IN PENANG, MALAYSIA.
P100029|S014|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2012|08/08/2012|||APPR|APPROVAL FOR ADDING AN INSPECTION FOR THE MAXIMUM LENGTH FOR CERTAIN FLAWS WHERE THE DEPTH CANNOT BE ACCURATELY ASSESSED.
P980016|S368|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice||N|07/19/2012|08/14/2012|||OK30|UPDATES TO THE HYBRID TESTING PROCESS.
P010031|S321|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D||CV|30-Day Notice||N|07/19/2012|08/14/2012|||OK30|UPDATES TO THE HYBRID TESTING PROCESS.
P060002|S027|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/19/2012|01/16/2013|||APPR|APPROVAL FOR A LINE EXTENSION OF THE FLAIR® ENDOVASCULAR STENT GRAFT TO ADD A 70 MM LENGTH. IN ADDITION, THERE ARE THREE ADDITIONAL MINOR CHANGES. THESE INCLUDED:  MANUFACTURING CORE MODIFICATION, DELIVERY SYSTEM FLARING MANDREL MODIFICATION, AND CHAMFER OF GUIDING TUBE MODIFICATION.
P840001|S222|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORESENSOR, 37714|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2012|08/01/2012|||OK30|DESIGN CHANGE TO THE POST STERILIZATION TEST SOFWARE.
P070015|S097|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2012|08/14/2012|||OK30|ADDITION OF A NEW TEST TO INSPECT TUBING USED IN THE MANUFACTURING OF STENTS FOR THE DEVICES.
P110019|S026|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2012|08/14/2012|||OK30|ADDITION OF A NEW TEST TO INSPECT TUBING USED IN THE MANUFACTURING OF STENTS FOR THE DEVICES.
P020047|S049|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION AND MINI-VISION CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2012|08/14/2012|||OK30|ADDITION OF A NEW TEST TO INSPECT TUBING USED IN THE MANUFACTURING OF STENTS FOR THE DEVICES.
P970020|S074|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM (CSS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2012|08/14/2012|||OK30|ADDITION OF A NEW TEST TO INSPECT TUBING USED IN THE MANUFACTURING OF STENTS FOR THE DEVICES.
P110001|S008|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|HERCULINK ELITE RX STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2012|08/14/2012|||OK30|ADDITION OF A NEW TEST TO INSPECT TUBING USED IN THE MANUFACTURING OF STENTS FOR THE DEVICES.
P050052|S036|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/2012|09/25/2012|||APPR|APPROVAL TO EXTEND THE LABELED SHELF  LIFE OF THE 3.0CC PRODUCT FILL VOLUME RADIESSE FROM 6 MONTHS TO 24 MONTHS.
P010032|S060|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON, EONC AND EON MINI NEUROSTIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2012|08/10/2012|||OK30|SOFTWARE REVISION TO AN IN-PROCESS INSPECTION STEP.
P050037|S033|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/2012|09/25/2012|||APPR|APPROVAL TO EXTEND THE LABELED SHELF LIFE OF THE 3.0CC PRODUCT FILL VOLUME RADIESSE FROM 6 MONTHS TO 24 MONTHS.
P080030|S003|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L|OGO|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/20/2012|03/05/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P930014|S063|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2012|08/09/2012|||OK30|IMPLEMENTATION OF A MODIFIED VALIDATED CURING CYCLE.
P960009|S152|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS IMPLANTABLE NEUROSTIMULATORS|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|12/03/2012|||APPR|APPROVAL FOR ADDITION OF THE IN-PROCESS INSPECTION FOR THE CATHOD MIX USED IN BATTERY MODELS.
P840001|S223|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION - IMPLANTABLE NEUROSTIMULATORS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|12/03/2012|||APPR|APPROVAL FOR ADDITION OF THE IN-PROCESS INSPECTION FOR THE CATHOD MIX USED IN BATTERY MODELS.
P970004|S138|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SACRAL NERVE STIMULATION - URINARY IMPLANTABLE NEUROSTIMULATORS|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|12/03/2012|||APPR|APPROVAL FOR ADDITION OF THE IN-PROCESS INSPECTION FOR THE CATHOD MIX USED IN BATTERY MODELS.
P080025|S035|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SACRAL NERVE STIMULATION- BOWEL IMPLANTABLE NEUROSTIMULATORS|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|12/03/2012|||APPR|APPROVAL FOR ADDITION OF THE IN-PROCESS INSPECTION FOR THE CATHOD MIX USED IN BATTERY MODELS.
P910056|S011|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ENVISTA INTRAOCULAR LENS (IOL)|HQL|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/23/2012|09/04/2012|||APPR|APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE (DFU) TO SPECIFY THAT THE ENVISTA MX60 LENS IS APPROVED FOR USE WITH THE MEDICEL ACCUJECT 2.6 INJECTOR SET, OR OTHER INJECTOR SETS THAT SPECIFICALLY IDENTIFY THE ENVISTA MX60 LENS IN THE CLEARED LABELING.
P900033|S022|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice||N|07/23/2012|08/22/2012|||OK30|CHANGES TO THE CLEANING PROCESSES ASSOCIATED WITH THE PRODUCTION EQUIPMENT.
P990001|S106|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VIATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|08/20/2012|||OK30|MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.
P960016|S039|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|SAFIRE ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2012|09/10/2012|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE PINION GEAR COMPONENT.
P100023|S051|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY SYSTEM (MONORAIL AND OVER THE WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|08/22/2012|||OK30|PRE-STERILIZATION EQUIPMENT CHANGE TO THE ETHYLENE OXIDE STERILIZATION PROCESS FOR THE DEVICE.
P980035|S281|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|08/20/2012|||OK30|MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.
P010031|S322|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II DF||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|08/20/2012|||OK30|MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.
P090013|S067|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG, RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|08/20/2012|||OK30|MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.
P010015|S167|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, C4TR01, SYNCRA CRT-P, C2TR01|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|08/20/2012|||OK30|MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.
P980016|S369|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2012|08/20/2012|||OK30|MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA.
P050039|S010|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2012|08/24/2012|||OK30|CHANGES TO THE PROCESS FOR USE OF THE BURST TEST FIXTURE, WHICH IS USED TO EVALUATE THE SEAL STRENGTH OF THE PACKAGING.
P090022|S013|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)|HQL|OP|Special (Immediate Track)||N|07/24/2012|08/16/2012|||APPR|APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING THAT ENHANCES THE SAFETY IN THE USE OF THE DEVICE.
P080030|S004|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L|OGO|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/20/2012|03/08/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P080030|S005|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L|OGO|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/20/2012|03/05/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960040|S267|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|ADD AN AUTOMATIC OPTICAL INSPECTION (AOI) SYSTEM USED TO INSPECT COMPONENT PLACED ON THE PRINTED CIRCUIT BOARD.
P010012|S297|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|ADD AN AUTOMATIC OPTICAL INSPECTION (AOI) SYSTEM USED TO INSPECT COMPONENT PLACED ON THE PRINTED CIRCUIT BOARD.
P980035|S282|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/17/2012|||OK30|NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
P010031|S323|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD,CONSULTA, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/17/2012|||OK30|NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
P090013|S068|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG, RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/17/2012|||OK30|NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
P020047|S050|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/24/2012|||OK30|IRRADIATION EQUIPMENT CHANGE FOR THE MANUFACTURING OF THE DEVICES.
P110019|S027|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/24/2012|||OK30|IRRADIATION EQUIPMENT CHANGE FOR THE MANUFACTURING OF THE DEVICES.
P990081|S012|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Real-Time Process||N|07/25/2012|08/21/2012|||APPR|APPROVAL FOR AN EXTENSION OF SHELF LIFE OF THE IVIEW DAB DETECTIONKIT AND THE ULTRAVIEW DAB DETECTION KIT FOR THE PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY.
P840001|S224|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, SYNERGY, SYNERGY VERSITREL, ITREL, POCKET ADAPTOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|ADDITION OF ANOTHER SUPPLIER FOR THE INNER SEAL SILICONE COMPONENT117988-001.
P960009|S153|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA, KINETRA, ACTIVA SC, POCKET ADAPTOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|ADDITION OF ANOTHER SUPPLIER FOR THE INNER SEAL SILICONE COMPONENT117988-001.
P970004|S139|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|ADDITION OF ANOTHER SUPPLIER FOR THE INNER SEAL SILICONE COMPONENT117988-001.
P080025|S036|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|ADDITION OF ANOTHER SUPPLIER FOR THE INNER SEAL SILICONE COMPONENT117988-001.
P010015|S168|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, C4TR01, SYNCRA CRT-P C2TR01|OJX|CV|30-Day Notice||N|07/25/2012|08/17/2012|||OK30|NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
P980016|S370|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/17/2012|||OK30|NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
P990001|S107|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/17/2012|||OK30|NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
P980016|S371|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|CMOS PROCESS FLOW CHANGES AT THE SUPPLIER.
P010015|S169|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|CMOS PROCESS FLOW CHANGES AT THE SUPPLIER.
P010031|S324|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|CMOS PROCESS FLOW CHANGES AT THE SUPPLIER.
P980035|S283|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/22/2012|||OK30|CMOS PROCESS FLOW CHANGES AT THE SUPPLIER.
P900033|S023|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2012|08/14/2012|||OK30|IMPROVEMENTS TO THE WATER FOR INJECTION SYSTEM ASSOCIATED WITH THE PRODUCTION OF THE DEVICE.
P020018|S046|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/2012|10/09/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE H & L-B ONE-SHOT INTRODUCTION SYSTEM.
P860004|S173|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2012|08/21/2012|||OK30|IMPLEMENTATION OF NEW PACKAGE OF SEALING EQUIPMENT.
P860004|S174|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2012|08/21/2012|||OK30|IMPLEMENTATION OF A NEW MOLD FOR A KIT COMPONENT.
P020045|S045|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CRYOCONSOLE, MODEL 106A3|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2012|09/21/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE FIRMWARE AND SOFTWARE WHICH ISUPGRADED FROM VERSION 4.03 TO 4.04.080 FOR THE DEVICE.
P960058|S097|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2012|08/24/2012|||OK30|CHANGE IN THE BIOLOGICAL INDICATOR USED IN THE FIRM¿S ETHYLENE OXIDE STERILIZATION PROCESS.
P970051|S092|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2012|08/24/2012|||OK30|IMPLEMENTATION OF A NEW CLEANING SYSTEM FOR THE IMPLANT ELECTRONIC ASSEMBLIES FOR THE C124RE(CA), C124RE(ST), AND C1422 NUCLEUS COCHLEAR IMPLANTS.
P910023|S299|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FORTIFY VR DF-4 FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2012|08/22/2012|||OK30|CHANGE TO THE TOOLING USED DURING THE ROUTING STEP OF THE MANUFACTURING PROCESS FOR THE FEEDTHRU.
P990081|S013|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2012|08/09/2012|||OK30|ADDITION OF A SUPPLIER OF RAW MATERIALS FOR THE IVIEW DETECTION KIT, WHICH IS PARTOF THE DEVICE.
P900033|S024|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2012|08/24/2012|||OK30|CHANGE IN THE INSPECTION PROCESS FOR THE MANUFACTURING EQUIPMENT.
P900033|S025|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2012|08/24/2012|||OK30|REPLACEMENT OF THE AIR HANDLING UNIT WITHIN A MANUFACTURING SUITE.
P110010|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2012|12/21/2012|||APPR|APPROVAL FOR A CHANGE TO THE BODY LENGTH OF THE DELIVERY SYSTEM BALLOON.
P020004|S074|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/13/2012|11/20/2012|||APPR|APPROVAL FOR THE ADDITION OF THE 35 MM TRUNK-IPSILATERAL LEG AND 36 MM AORTIC EXTENDER COMPONENTS TO THE GORE EXCLUDER AAA ENDOPROSTHESIS PRODUCT PORTFOLIO.
P910077|S123|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATTITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/27/2012|09/25/2012|||APPR|APPROVAL FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM APPLICATION SERVER SOFTWARE V7.03.0 1 ON LATITUDE SYSTEM SERVER (MODEL 6488).
P020050|S008|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2012|09/07/2012|||APPR|APPROVAL FOR INTRODUCTION OF A NEW NOTEBOOK COMPUTER MODEL(TOSHIBA TECRA A11) TO REPLACE THE CURRENT NOTEBOOK MODEL (TOSHIBA TECRA M10) WHICH IS BEING PHASED OUT BY THE MANUFACTURER. THIS WILL REQUIRE A CHANGE IN THE OPERATING SYSTEM FROM WINDOWS 2000 TO WINDOWS XP SERVICE PACK 2 AS THE NEW NOTEBOOK COMPUTER WILL NOT BESUPPORTED BY THE OLD SYSTEM.
P030008|S008|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/30/2012|09/07/2012|||APPR|APPROVAL FOR INTRODUCTION OF A NEW NOTEBOOK COMPUTER MODEL(TOSHIBA TECRA A11) TO REPLACE THE CURRENT NOTEBOOK MODEL (TOSHIBA TECRA M10) WHICH IS BEING PHASED OUT BY THE MANUFACTURER. THIS WILL REQUIRE A CHANGE IN THE OPERATING SYSTEM FROM WINDOWS 2000 TO WINDOWS XP SERVICE PACK 2 AS THE NEW NOTEBOOK COMPUTER WILL NOT BESUPPORTED BY THE OLD SYSTEM.
P050046|S015|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE IMPLANTABLE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2012|08/27/2012|||OK30|ADDITIONAL SUPPLIER FOR A LEAD COMPONENT.
P010032|S061|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS, GENESISRC AND GENESIS XP NEUROSTIMULATION SYSTEMS|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2012|05/08/2013|||APPR|APPROVAL TO ELIMINATE THE USE OF LIQUID NO-CLEAN SOLDER FLUX AND TO CHANGE THE SOLID FLUX CORE WIRE USED IN THE SOLDERING PROCESS.
P070015|S098|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|07/30/2012|08/27/2012|||OK30|ALTERNATE STORAGE CONDITIONS FOR THE LONG-TERM STORAGE OF THE EVEROLIMUS DRUG SUBSTANCE.
P110019|S028|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|07/30/2012|08/27/2012|||OK30|ALTERNATE STORAGE CONDITIONS FOR THE LONG-TERM STORAGE OF THE EVEROLIMUS DRUG SUBSTANCE.
P950029|S071|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR AND DR, ESPRIT SR AND DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2012|08/23/2012|||OK30|ADDITION OF A CLEANING STEP AND NEW ELECTRICAL TEST EQUIPMENT.
P980049|S077|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR AND DR, PARADYM RF VR AND DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2012|08/23/2012|||OK30|ADDITION OF A CLEANING STEP AND NEW ELECTRICAL TEST EQUIPMENT.
P060027|S045|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D, PARADYM RF CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2012|08/23/2012|||OK30|ADDITION OF A CLEANING STEP AND NEW ELECTRICAL TEST EQUIPMENT.
P100044|S002|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL SINUS IMPLANT|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2012|08/10/2012|||OK30|MODIFICATION TO A QUALITY CONTROL TEST USED ON AN INCOMING COMPONENT.
P970051|S093|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|07/31/2012|01/03/2013|||APPR|APPROVAL FOR A NEW VERSION OF THE CUSTOM SOUND SOFTWARE FOR PROGRAMMING OF THE NUCLEUS COCHLEAR IMPLANTS, TO BE KNOWN AS CUSTOM SOUND 3.3.
P980016|S372|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2012|08/27/2012|||OK30|UPDATE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 INTEGRATED CIRCUITS.
P010015|S170|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P AND SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2012|08/27/2012|||OK30|UPDATE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 INTEGRATED CIRCUITS.
P060033|S071|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAOVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2012|08/31/2012|||OK30|MANUFACTURING EQUIPMENT CHANGE TO THE INITIAL CRIMP STENT PROCESS.
P980035|S284|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, A4DR01|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2012|08/27/2012|||OK30|UPDATE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 INTEGRATED CIRCUITS.
P010031|S325|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2012|08/27/2012|||OK30|UPDATE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 INTEGRATED CIRCUITS.
P910001|S061|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2012|09/05/2012|||OK30|USE OF ADDITIONAL STERILIZATION CHAMBERS AT THE CONTRACT STERILIZER.
P960042|S041|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANENETICS LASER SHEATHS SLS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2012|09/05/2012|||OK30|USE OF ADDITIONAL STERILIZATION CHAMBERS AT THE CONTRACT STERILIZER.
P110001|S009|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|RX HERCULINK ELITE RENAL STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2012|10/09/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR CARDIAC THERAPIES IN CLONMEL, IRELAND.
P970051|S094|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEMS|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/02/2012|01/21/2014|||APPR|APPROVAL FOR THE COCHLEAR INTEGRITY TEST SYSTEM (CITS).
P980016|S373|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II ICD, MAXIMO VR ICD, PROTECTA ICD,|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P830061|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEADS, VITATRON CRYSTALINE LEADS, VITATRON EXCELLENCE PS+ LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P850089|S089|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEADS, CAPSURE SP Z LEADS, CAPSURE Z NOVUS LEAD, CAPSURE Z NOVUS LEADS, IMPULSE II LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P890003|S255|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEADS 5038, 5038L, 5038S,IMW14Q,IMW15Q, IMW16Q, IMW17Q, IMW18Q, PRODIGY IPG, 8158|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P920015|S094|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO L|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P930039|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD, VITATRON CRYSTA|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P980050|S075|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD, 6937 A|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P990001|S108|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P010015|S171|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P950024|S042|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD, 4665, 4968|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P980035|S285|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ADVISA DR IPG, ENRHYTHM IPG, RELIA IPG, SIGMA DR IPG, SIGMA S I|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P060007|S019|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|CHANGE TO THE MANUFACTURING MATERIAL USED TO FILTER THE COMMON ACCESSORIES.
P080006|S042|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEADS 4196, 4296 AND 4396|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P090013|S069|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD 6086MRI, REVO MRI IPG, RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P110029|S003|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|CHANGE TO THE MANUFACTURING MATERIAL USED TO FILTER THE COMMON ACCESSORIES.
P050051|S015|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|CHANGE TO THE MANUFACTURING MATERIAL USED TO FILTER THE COMMON ACCESSORIES.
P060035|S014|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|CHANGE TO THE MANUFACTURING MATERIAL USED TO FILTER THE COMMON ACCESSORIES.
P080023|S015|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|CHANGE TO THE MANUFACTURING MATERIAL USED TO FILTER THE COMMON ACCESSORIES.
P010031|S326|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO II CRT-D, PROTECT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P030036|S046|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT, SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P060039|S035|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD, 4195|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P070026|S007|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|09/06/2012|||APPR|APPROVAL FOR THE ADDITION OF AN INDEPENDENT INSPECTOR TO PERFORM VISUAL CHECK OF THE S-ROM FEMORAL STEM COMPONENT STERILE PACKAGING.
P050042|S018|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|CHANGE TO THE MANUFACTURING MATERIAL USED TO FILTER THE COMMON ACCESSORIES.
P980007|S026|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|08/29/2012|||OK30|CHANGE TO THE MANUFACTURING MATERIAL USED TO FILTER THE COMMON ACCESSORIES.
P910007|S035|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/29/2012|||OK30|CHANGE TO THE MANUFACTURING MATERIAL USED TO FILTER THE COMMON ACCESSORIES.
P040023|S024|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|09/06/2012|||APPR|APPROVAL FOR THE ADDITION OF AN INDEPENDENT INSPECTOR TO PERFORM VISUAL CHECK OF THE S-ROM FEMORAL STEM COMPONENT STERILE PACKAGING.
P090002|S005|DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|09/06/2012|||APPR|APPROVAL FOR THE ADDITION OF AN INDEPENDENT INSPECTOR TO PERFORM VISUAL CHECK OF THE S-ROM FEMORAL STEM COMPONENT STERILE PACKAGING.
P030031|S045|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|UNIDIRECTIONAL THERMOCOOL SF NAV CATHETER|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/03/2012|10/02/2012|||APPR|APPROVAL FOR EXTENDING THE SHELF LIVE FOR THE CATHETER IN THE OBJECT OF THE CURRENT LETTER FROM ONE TO THREE YEARS.
P010032|S062|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PENTA LEAD SERIES|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/31/2012|||OK30|CHANGE THE IN- PROCESS DIMENSIONAL INSPECTION FOR THE DEVICES.
P980022|S120|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK REAL-TIME TRANSMITTER (MMT-7703)|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/17/2012|||OK30|TRANSFER OF THE SUB-ASSEMBLY MANUFACTURING PROCESSES OF THE MINILINK REAL-TIME TRANSMITTER (MMT-7703) FROM INTRICON CORPORATION IN ARDEN HILLS, MINNESOTA TO ANALTERNATE MANUFACTURING FACILITY AT INTRICON IN ADMIRAX, SINGAPORE. THE MINILINK REAL-TIME TRANSMITTER IS A COMPONENT OF THE DEVICES.
P020009|S090|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/31/2012|||OK30|REMOVAL OF IN- PROCESS MONITORING FOR SEAL BURST TESTING.
P040016|S094|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/31/2012|||OK30|REMOVAL OF IN- PROCESS MONITORING FOR SEAL BURST TESTING.
P060006|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/31/2012|||OK30|REMOVAL OF IN- PROCESS MONITORING FOR SEAL BURST TESTING.
P050006|S029|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2012|11/26/2012|||APPR|APPROVAL FOR USE OF NEW TESTING EQUIPMENT.
P970051|S095|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2012|09/05/2012|||OK30|RE-COMMISSIONING OF A CLEAN ROOM AND ESTABLISHMENT OF A NEW MANUFACTURING LINE.
P980016|S374|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA ICD AND PROTECTA XT ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2012|09/04/2012|||OK30|SOFTWARE UPDATE TO A CD SURGE TEST.
P010031|S327|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA CRT-D, D334TRG, D334TRM, PROTECTA XT CRT-D, D314TRG, D314TRM||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2012|09/04/2012|||OK30|SOFTWARE UPDATE TO A CD SURGE TEST.
P910056|S012|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|EN VISTA PIECE HYDROPHOBIC ACRYLIC LENS, MODEL MX60|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2012|08/31/2012|||OK30|ALTERNATE MILLING SITE AND AN ALTERNATE SOURCE FOR A MATERIAL USED FOR THE MANUFACTURING OF THE LENSES.
P980016|S375|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2012|08/31/2012|||OK30|UPDATE TEST SOFTWARE FOR THE CD SURGE TESTER.
P010031|S328|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD AND MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2012|08/31/2012|||OK30|UPDATE TEST SOFTWARE FOR THE CD SURGE TESTER.
P030017|S140|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/07/2012|10/01/2012|||APPR|APPROVAL FOR MINOR PACKAGING DESIGN CHANGES TO THE INNER TRAY AND INNER TRAY COVER FOR THE PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM IMPLANTABLE PULSE GENERATOR (IPG) KITS.
P910023|S300|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT, FORTIFY, ELLIPSE ASSURA FAMILY OF ICD DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2012|08/30/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A SEAL COMPONENT.
P030054|S228|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC, ATLAS, PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA FAMILY OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2012|08/30/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A SEAL COMPONENT.
P110037|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|08/07/2012|09/05/2012|||APPR|APPROVAL FOR A CHANGE TO THE TEST DEFINITION FILE (TDF).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLIPREP/COBAS TAQMAN CMV TEST AND IS INDICATED FOR:  COBAS AMPLIPREP/COBAS TAQMAN CMV TEST THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATIVE MEASUREMENT OF CYTOMEGALOVIRUS (CMV) DNA INHUMAN EDTA PLASMA USING THE COBAS AMPLIPRCP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THE COBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE COBAS AMPLIPRCP/ COBAS TAQMAN CMV TEST IS INTENDED FOR USC AS AN AID IN THE MANAGEMENT OFSOLID-ORGAN TRANSPLANT PATIENTS WHO ARC UNDERGOING ANTI-CMV THERAPY. IN THIS POPULATION SERIAL DNA MEASUREMENTS CAN BE USED TO ASSESS VIROLOGICAL RESPONSE TO ANTIVIRAL TREATMENT. THE RESULTS FROM THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.  THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF CMV DNA IN BLOOD OR BLOOD PRODUCTS.
P010015|S172|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2012|09/05/2012|||OK30|INCREASE IN A TEST LIMIT ON THE FEED THROUGH ASSEMBLY AT THE SUPPLIER LOCATION.
P970003|S151|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2012|09/06/2012|||OK30|ADDITION OF A FIXTURE FOR CLEANING OF A COMPONENT.
P010031|S329|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTA, CONSULTA/CONSULTA DF4, & VARIOUS INSYNC FAMILIES OF ICD'S; CONCERTO II, MAXIMO II,PROTECTA,PROTECTA XT CRT-D'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/2012|10/26/2012|||APPR|APPROVAL FOR THE MEDTRONIC ICD LONGEVITY ESTIMATION TOOL (MILET) TO BE USED BY MEDTRONIC PERSONNEL FOR THE DEVICES.
P980050|S076|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/2012|10/26/2012|||APPR|APPROVAL FOR THE MEDTRONIC ICD LONGEVITY ESTIMATION TOOL (MILET) TO BE USED BY MEDTRONIC PERSONNEL FOR THE DEVICES.
P980016|S376|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST,SECURA,GEM II/III VR/DR,INTRINSIC/INTRINSIC 30,MAXIMO VR/DR,MAXIMO II,MARQUIS VR/DR,PROTECTA/PROTECTA XT|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/2012|10/26/2012|||APPR|APPROVAL FOR THE MEDTRONIC ICD LONGEVITY ESTIMATION TOOL (MILET) TO BE USED BY MEDTRONIC PERSONNEL FOR THE DEVICES.
P060040|S024|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2012|10/05/2012|||APPR|APPROVAL TO EXTEND THE SHELF-LIFE OF BOTH THE HEARTMATE II (HM II) SEALED OUTFLOW GRAFT AND THE SEALED INFLOW CONDUIT FROM THE CURRENT LABELING OF THREE YEARS TO FIVE YEARS.
P900061|S115|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|END CAP 6701,EPICARDIAL PATCH LEAD 6721L, 6721M, 6721S,SIZING SLEEVE 6920,UPSIZING SLEEVE 6925|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2012|08/30/2012|||OK30|MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
P980016|S377|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2012|09/05/2012|||OK30|IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1.
P010015|S173|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, C4TR01 AND SYNCRA CRT-P, C2TR01|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2012|09/05/2012|||OK30|IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1.
P010031|S330|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II, CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2012|09/05/2012|||OK30|IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1.
P090013|S070|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG, RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2012|09/05/2012|||OK30|IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1.
P980035|S286|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2012|09/05/2012|||OK30|IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1.
P030022|S022|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2012|09/06/2012|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR THE ANTHOLOGY HIP STEM POROUS COATING PROCESS.
P950037|S111|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|REOCOR S/D EXTERNAL PACEMAKER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/10/2012|09/24/2012|||APPR|APPROVAL FOR A CHANGE TO THE LOW IMPEDANCE ALARM AND OTHER MINOR CHANGES.
P010038|S016|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECONDLOOK DIGITAL V7.2 CAD|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/2012|11/09/2012|||APPR|APPROVAL FOR  THE SECONDLOOK DIGITAL V7.2 CAD FOR USE WITH THE PHILIPS MICRODOSE FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM.
P000025|S063|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/10/2012|06/06/2013|||APPR|APPROVAL FOR NEW LABELING THAT DESCRIBES CONDITIONS FOR SAFE MAGNETIC RESONANCE (MR) IMAGING AT 0.2 AND 1.5 TESLA FIELD STRENGTHS AND RADIATION THERAPY OF PATIENTS IMPLANTED WITH THE MED-EL COCHLEAR IMPLANT SYSTEMS WHICH INCLUDE THE PULSARCI100, SONATATI100, MED-EL CONCERT, MED-EL CONCERT PIN IMPLANTS.
P910071|S014|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-O1 5000 SILICONE OIL|LWL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/10/2012|08/31/2012|||APPR|APPROVAL FOR THE LABELING CHANGES TO YOUR DIRECTIONS FOR USE (DFU).  THE DFU WAS REVISED TO INCLUDE SAFETY INFORMATION REGARDING THE USE OF CO2 LASERS IN INSTANCES WHERE SILICONE OIL MAY HAVE MIGRATED OUT OF THE EYE AND FORMED LESIONS IN THE CONJUCTIVA OR EYELID.
P980035|S287|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ENRHYTHM IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/10/2012|||OK30|UPDATE TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P890003|S256|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG 8158|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/10/2012|||OK30|UPDATE TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P070015|S099|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/07/2012|||OK30|CHANGE TO THE METHOD USED TO TEST FOR DRUG RELEASE.
P110019|S030|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/07/2012|||OK30|CHANGE TO THE METHOD USED TO TEST FOR DRUG RELEASE.
P040003|S012|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE SYSTEM|NRZ|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/07/2012|||OK30|CHANGE IN THE MANUFACTURING OF THE TRANSDUCER FOR THE EXABLATE SYSTEM FROM A CONTRACT MANUFACTURER TO THE IN-HOUSE FACILITY.
P010012|S298|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNTUA, INCEPTA AND ENERGEN CRT-D FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/11/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TANTALUM CAPACITORS.
P960040|S268|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNTUA, INCEPTA AND ENERGEN ICD'S FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/11/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE TANTALUM CAPACITORS.
P090013|S071|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG, RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/10/2012|||OK30|UPDATE TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P950020|S052|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||FLEXTOME CUTTING BALLOON DILATATION DEVICE||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P060008|S094|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P050019|S010|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P930031|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TRANSJUGULAR PORTOSYSTEMICSHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P980033|S023|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P940019|S029|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P040016|S095|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM (MONORAIL)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P090003|S015|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P100023|S052|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P110010|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2012|09/06/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P090012|S002|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/13/2012|10/02/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880086|S222|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice||N|08/15/2012|09/14/2012|||OK30|CLARIFICATION OF THE VISUAL INSPECTION CRITERIA FOR LOW VOLTAGE PULSE GENERATORS.
P840001|S225|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE RECHARGEABLE,RESTORE PRIME,RESTORE,ADVANCED,PRIME ADVANCED,RESTORE ULTRA,ITREL 4,SYNERGY,SYNERGY VERSTIREL|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2012|09/12/2012|||OK30|CHANGE THE ACCEPTANCE CRITERIA FOR TITANIUM CONTENT IN THE CABLES AND TO ADD AN ALTERNATE SUPPLIER FOR THE CABLE BRAIDING AND MICRO-EXTRUSION PROCESSES.
P960009|S154|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2012|09/12/2012|||OK30|CHANGE THE ACCEPTANCE CRITERIA FOR TITANIUM CONTENT IN THE CABLES AND TO ADD AN ALTERNATE SUPPLIER FOR THE CABLE BRAIDING AND MICRO-EXTRUSION PROCESSES.
P050028|S026|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST, HIGH PURE/COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2012|09/14/2012|||OK30|CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY.
P000012|S039|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, V2.0, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2012|09/14/2012|||OK30|CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY.
P030035|S100|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM FAMILY OF PACEMAKERS|NIK|CV|30-Day Notice||N|08/15/2012|09/14/2012|||OK30|CLARIFICATION OF THE VISUAL INSPECTION CRITERIA FOR LOW VOLTAGE PULSE GENERATORS.
P060030|S028|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2012|09/14/2012|||OK30|CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY.
P110037|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2012|09/14/2012|||OK30|CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY.
P100020|S006|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2012|09/14/2012|||OK30|CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY.
P110020|S005|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2012|09/14/2012|||OK30|CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY.
P070014|S033|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2012|09/12/2012|||APPR|APPROVAL FOR THE SEPARATION OF THE MANUFACTURING AND INSPECTION RESPONSIBILITIES FOR THE MANUAL PRESS PROCESS.
P830055|S127|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2012|11/19/2012|||APPR|APPROVAL FOR THE ADDITION OF MOBILE BEARING ATTUNE PS RP TIBIAL INSERTS THAT ARE MODIFICATIONS TO THE PREVIOUSLY APPROVED LCS COMPLETE/PFC SIGMA RP/ATTUNE RP TIBIAL INSERTS, AND ARE INTENDED TO BE USED WITH THE CLEARED ATTUNE TOTAL KNEE SYSTEM FEMORAL, PATELLA, AND COMPONENTS. THE SUPPLEMENT ALSO REQUESTS THE ADDITION OF A 9MM TIBIAL INSERT THICKNESS FOR ALL SIZES (I - I 0) OF ATTUNE CR RP TIBIAL INSERTS. THE NEWINSERTS ARE MANUFACTURED FROM THE ANTIOXIDANT POLYETHYLENE MATERIAL (AOX). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATTUNE AND IS INDICATED FOR USE IN TOTAL KNEE REPLACEMENT IN PATIENTS WITH A SEVERELY PAINFUL AND/OR SEVERELY DISABLED JOINT RESULTING FROM OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, OR A FAILED PREVIOUS IMPLANT.
P980037|S040|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2012|10/16/2012|||APPR|APPROVAL FOR CHANGING THE PACKAGING TRAY MATERIAL FOR THE ANGIOJET ULTRA XMI, ULTRA SPIROFLEX, AND ULTRA SPIROFLEX VG THROMBECTOMY SETS FROM PETG TO PETG DENEST, AS WELL AS CHANGING THE MANUFACTURING OF THESE PACKAGING TRAYS FROM PERFECSEAL TO BROOKDALE.
P030054|S230|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF/ ATLAS + HF PROMOTE FAMILY OF CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2012|11/07/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MERLIN PCS PROGRAMMER.
P910023|S302|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE CURRENT FAMILY OF ICD'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2012|11/07/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MERLIN PCS PROGRAMMER.
P880086|S223|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2012|11/07/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MERLIN PCS PROGRAMMER.
P030035|S101|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2012|11/07/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MERLIN PCS PROGRAMMER.
P880006|S082|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2012|11/07/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MERLIN PCS PROGRAMMER.
P970013|S051|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2012|11/07/2012|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MERLIN PCS PROGRAMMER.
P950020|S053|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||FLEXTOME CUTTING BALLOON||CV|30-Day Notice||N|08/16/2012|09/07/2012|||OK30|AN ALTERNATE SUPPLIER FOR THE BALLOON PROTECTOR CAP COMPONENT; AND MINOR DIMENSIONAL CHANGES FOR THE BALLOON PROTECTOR CAP COMPONENT.
P880086|S224|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT FAMILY OF DEVICES|NVZ|CV|30-Day Notice||N|08/16/2012|09/12/2012|||OK30|ALTERNATE SUPPLIER FOR THE ELECTROMAGNETIC COIL RECEIVER USED IN THE VOICE COIL ASSEMBLY.
P030035|S102|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM FAMILY OF DEVICES|NIK|CV|30-Day Notice||N|08/16/2012|09/12/2012|||OK30|ALTERNATE SUPPLIER FOR THE ELECTROMAGNETIC COIL RECEIVER USED IN THE VOICE COIL ASSEMBLY.
P970029|S021|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/16/2012|09/13/2012|||APPR|APPROVAL  FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THE DEVICE DESCRIPTION, WARNINGS, ADVERSE EFFECTS AND DEVICE OPERATING INSTRUCTIONS.
P080012|S006|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|30-Day Notice||N|08/16/2012|09/13/2012|||OK30|NEW ALTERNATE SUB-TIER SUPPLIER FOR A COMPONENT OF THE DEVICE.
P980022|S121|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN REAL-TIME SYSTEM, PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2012|09/13/2012|||OK30|REINSTATEMENT OF THE AYUTTHAYA, THAILAND FACILITY AS AN ADDITIONAL FACILITY FOR THE MANUFACTURE OF PRINTED CIRCUIT BOARD ASSEMBLIES AND STACK SUBASSEMBLIES USED BY MEDTRONIC MINIMED IN THE PRODUCTION OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K)) AND GUARDIAN REAL-TIME MONITOR (CSS7100, CSS7 100K). THE PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, AND GUARDIAN REAL-TIME MONITOR ARE COMPONENTS OF THE DEVICES.
P050006|S030|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2012|09/07/2012|||OK30|REDESIGNED FLARING EQUIPMENT AND REDUCTION OF THE SAMPLING PLANS FOR THE DEVICE LOCK RELEASE FORCE.
P060007|S020|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2012|09/14/2012|||OK30|CHANGE TO A TEST METHOD USED IN THE MANUFACTURE OF THE COMPONENTS OF THEARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAY, AND THE ARCHITECT HBSAG
P110029|S004|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2012|09/14/2012|||OK30|CHANGE TO A TEST METHOD USED IN THE MANUFACTURE OF THE COMPONENTS OF THEARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAY, AND THE ARCHITECT HBSAG
P970003|S152|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY PULSE GENERATOR, 102/102R|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2012|09/13/2012|||OK30|USE OF ALTERNATE SCHOTTKY DIODES FOR THE VNS THERAPY IMPLANTABLE PULSE GENERATORS AND THE PROGRAMMING WAND.
P080012|S007|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2012|09/11/2012|||OK30|USE OF AN ALTERNATE SUB-TIER SUPPLIER FOR A COMPONENT OF THE DEVICE.
P030017|S141|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2012|09/14/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE CHARGER ASSEMBLY.
P850079|S054|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A&B SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2012|09/11/2012|||OK30|RELOCATION OF A MANUFACTURING LINE AND INSTALLATION OF SUPPORTING PARTS.
P840001|S226|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL, SYNERGEY, RESTOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2012|09/13/2012|||OK30|ADDITION OF MANUFACTURING EQUIPMENT AT YOURMPROC-JUNCOS FACILITY GERMANE TO ITREL, SYNERGY, RESTORE, SOLETRA, KINETRA, INTERSTIM AND ENTERRA NEUROSTIMULATOR.
P960009|S155|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA, KINETRA, ACTIVA|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2012|09/13/2012|||OK30|ADDITION OF MANUFACTURING EQUIPMENT AT YOURMPROC-JUNCOS FACILITY GERMANE TO ITREL, SYNERGY, RESTORE, SOLETRA, KINETRA, INTERSTIM AND ENTERRA NEUROSTIMULATOR.
P970004|S140|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2012|09/13/2012|||OK30|ADDITION OF MANUFACTURING EQUIPMENT AT YOURMPROC-JUNCOS FACILITY GERMANE TO ITREL, SYNERGY, RESTORE, SOLETRA, KINETRA, INTERSTIM AND ENTERRA NEUROSTIMULATOR.
P080025|S037|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2012|09/13/2012|||OK30|ADDITION OF MANUFACTURING EQUIPMENT AT YOURMPROC-JUNCOS FACILITY GERMANE TO ITREL, SYNERGY, RESTORE, SOLETRA, KINETRA, INTERSTIM AND ENTERRA NEUROSTIMULATOR.
P850079|S055|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|COPPERVISION METHAFILCON AB SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2012|09/18/2012|||OK30|TEMPORARY CHANGE TO THE INSPECTION PROCESS.
P010047|S022|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|135 Review Track For 30-Day Notice||N|08/20/2012|04/04/2013|||APPR|APPROVAL FOR CHANGE TO A RESIN SUPPLIER.
P060022|S014|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, AO60, M160|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2012|10/04/2012|||OK30|NEW SUPPLIER FOR THE 2-HYDROXYL ETHYL METHACRYLATE (HEMA) MONOMER USED IN THE MANUFACTURE OF AKREOS IOLS.
P980044|S014|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2012|09/18/2012|||OK30|MODIFICATION OF AN EXISTING WATER SYSTEM.
P100010|S018|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|CRYOBLATION CONSOLE|OAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/2012|09/21/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE FIRMWARE AND SOFTWARE WHICH ISUPGRADED FROM VERSION 4.03 TO 4.04.080 FOR THE DEVICE.
P890003|S257|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY, 8158|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR PACKAGING MATERIALS, AND A CHANGE TO THE ORIENTATION OF AN IDENTIFICATION NUMBER ON THE PACKAGING
P060001|S017|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE RX CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/21/2012|02/12/2013|||APPR|APPROVAL FOR THE ADDITION OF THE CREATE POST- APPROVAL STUDY (PAS) RESULTS TO THE INSTRUCTIONS FOR USE (IFU).
P080030|S006|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/18/2012|||OK30|ADDITION OF A SECOND CLEAN ROOM AND TO PERFORM IN HOUSE PEEL TESTING.
P000058|S050|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|10/25/2012|||APPR|APPROVAL FOR THE EXTENSION OF THE EXPIRY OF BATCH REFERENCE MATERIAL.
P050027|S004|KARL STORZ ENDOSCOPY-AMERICA, INC.|2151 E. GRAND AVE.||EL SEGUNDO|CA|90245||Light source system, diagnostic endoscopic|KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM|OAY|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/2012|09/10/2012|||APPR|APPROVAL OF CORRECTIONS TO THE ETHYLENE OXIDE (ETO) STERILIZATION INSTRUCTIONS CONTAINED IN THE PDD CAMERA HEADS INSTRUCTION CARD, HOPKINS II PDD TELESCOPES INSTRUCTION MANUAL AND TRICAM SL II CAMERA CONTROL UNIT INSTRUCTION MANUAL.
P080006|S043|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEADS, 4196, 4296, AND 4396|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR PACKAGING MATERIALS, AND A CHANGE TO THE ORIENTATION OF AN IDENTIFICATION NUMBER ON THE PACKAGING
P980035|S288|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA ADSR01, ADSR03, ADSR06, RELIA RESO1, RESR01, SENSIA SES01, SESR01|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|ADDITION OF A NEW SUPPLIER FOR PACKAGING MATERIALS, AND A CHANGE TO THE ORIENTATION OF AN IDENTIFICATION NUMBER ON THE PACKAGING
P000054|S035|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|10/25/2012|||APPR|APPROVAL FOR THE EXTENSION OF THE EXPIRY OF BATCH REFERENCE MATERIAL.
P980016|S378|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|UPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.
P980035|S289|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|UPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.
P050053|S026|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|10/25/2012|||APPR|APPROVAL FOR THE EXTENSION OF THE EXPIRY OF BATCH REFERENCE MATERIAL.
P010015|S174|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|UPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.
P010031|S331|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|UPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.
P060037|S019|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|02/20/2013|||APPR|APPROVAL FOR INCORPORATION OF A LARGER TRANSFER BASKET FOR THE PRE-STERILIZATION CLEANING PROCESS.
P860057|S091|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CAPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.
P870056|S051|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.
P870077|S046|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CAPENTIER-EDWARDS S.A.V. BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.
P000007|S033|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.
P010041|S035|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. NIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.
P100041|S014|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2012|09/19/2012|||OK30|MODIFY THE LAYOUT OF AN ISOLATION CLEAN ROOM.
P070014|S034|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2012|09/21/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR TANTALUM MARKERS.
P980022|S122|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2012|09/18/2012|||OK30|MANUFACTURING PROCESS CHANGE WHICH WILL INCORPORATE THE ADDITION OF PROCESS WATER TO A ONCE-DILUTED BATCH OF PLATINUM PLATING SOLUTION FOR THE SOF-SENSORGLUCOSE SENSORS (MODELS MMT-7002 AND MMT-7003) THAT ARE COMPONENTS OF THE DEVICES.
P000037|S029|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2012|09/19/2012|||OK30|MODIFICATION TO THE LIMULUS AMEBOCYTE LYSATE (LAL) TEST METHOD AND PROCEDURE.
P980016|S379|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DF-4 CRT-D, MAXIMO II DF-4 ICD, MAXIMO II ICD, PROTECTA DF4-ICD, PROTECTA ICD, PROTECTA XT DF-4 ICD, PROTECTA|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2012|09/20/2012|||OK30|UPDATE ACCEPTANCE CRITERIA INSPECTION PROCESS FOR ALL DIE LOCATIONS ON ALL HYBRIDS.
P010031|S332|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D,  PROTECTA CRT-D, PROTECTA DF4||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2012|09/20/2012|||OK30|UPDATE ACCEPTANCE CRITERIA INSPECTION PROCESS FOR ALL DIE LOCATIONS ON ALL HYBRIDS.
P000032|S038|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/23/2012|02/06/2013|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY.
P840062|S023|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS|LPG|DE|30-Day Notice||N|08/23/2012|09/14/2012|||OK30|CHANGE IN CHART RECORDING SYSTEM.
P030031|S047|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SF CATHETERS (BI-DIRECTIONAL), THERMOCOOL SF CATHETERS (UNI-DIRECTIONAL)|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2012|09/20/2012|||OK30|NEW TEST EQUIPMENT FOR THE DEVICES.
P040012|S049|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CARTOID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2012|09/21/2012|||OK30|CHANGE TO THE DISPENSING SYSTEM FOR APPLYING CONTROLLED AMOUNTS OF ASSEMBLY FLUIDS DURING THE MANUFACTURING PROCESS.
P810006|S034|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice||N|08/23/2012|09/14/2012|||OK30|CHANGE IN CHART RECORDING SYSTEM.
P850010|S031|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice||N|08/23/2012|09/14/2012|||OK30|CHANGE IN CHART RECORDING SYSTEM.
P980018|S016|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCAP TEST|MVC|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/2012|02/22/2013|||APPR|APPROVAL FOR ADDITION OF KADCYLA¿ (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HERCEP TEST ¿.
P100023|S053|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|IOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2012|09/27/2012|||APPR|APPROVAL FOR REMOVAL OF THE BALL FROM THE TIP OF THE COREWIRE WHICH ISLOCATED BETWEEN THE INNER AND OUTER LUMEN OF THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND ION PACLITAXEL-ELUTING PLATINUM CHROMIUMCORONARY STENT SYSTEM AND ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH, AND FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >2.25 MM TO >4.00 MM IN DIAMETER IN LESIONS <34 MM IN LENGTH, RESPECTIVELY
P110043|S001|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2012|09/07/2012|||OK30|NEW STRAIGHTNESS TEST FOR COBALT CHROMIUM STENT TUBING.
P110010|S028|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2012|09/27/2012|||APPR|APPROVAL FOR REMOVAL OF THE BALL FROM THE TIP OF THE COREWIRE WHICH IS LOCATED BETWEEN THE INNER AND OUTER LUMEN OF THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH, AND FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >2.25 MM TO <4.00 MM IN DIAMETER IN LESIONS <34 MM IN LENGTH, RESPECTIVELY
P980016|S380|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA ICD, PROTECTA XT ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2012|09/20/2012|||OK30|UPDATE TO THE MANUFACTURING TEST FOR AN INTEGRATED CIRCUIT (IC) AT THE SUPPLIER LOCATION.
P010031|S333|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2012|09/20/2012|||OK30|UPDATE TO THE MANUFACTURING TEST FOR AN INTEGRATED CIRCUIT (IC) AT THE SUPPLIER LOCATION.
P850079|S056|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|COOPERVISION METHAFILCON AB EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice||N|08/24/2012|09/18/2012|||OK30|NEW MANUFACTURING LINE.
P100040|S009|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2012|09/21/2012|||OK30|AUTOMATION OF A CUTTING/SEALING STEP.
P070007|S036|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2012|09/21/2012|||OK30|AUTOMATION OF A CUTTING/SEALING STEP.
P070027|S035|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2012|09/21/2012|||OK30|AUTOMATION OF A CUTTING/SEALING STEP.
P040005|S009|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 FISH PHARMADX KIT|MVD|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/24/2012|02/22/2013|||APPR|APPROVAL FOR ADDITION OF KADCYLA (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HER2 IQ-FISH PHARMDX KIT.
P100034|S002|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOTTF-100A SYSTEM|NZK|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/28/2012|12/03/2012|||APPR|APPROVAL FOR MODIFICATION TO THE FIELD GENERATOR COMPONENT OF THENOVOTTF-L00A SYSTEM TO REPLACE PIN: DAC7614E WITH PIN: 2IC-103572, AND CORRESPONDING CHANGES TO THE ASSOCIATED RESISTORS AND CAPACITORS TO LIMIT THE PART VOLTAGE RANGE AND ELIMINATE AN OBSERVED CURRENT SPIKE.   CORRESPONDING SOFTWARE CHANGES WERE ALSO MADE TO REFLECT THESEMODIFICATIONS.
P070006|S008|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT .TB TEST|OJN|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2012|09/05/2012|||APPR|APPROVAL FOR A DESIGN CHANGE, FOR A LARGER REAGENT VOLUME FORMAT FORTHE T-CELL XTEND REAGENT, AN ACCESSORY TO THE T-SPOT TB TEST, TO INCREASE THE VOLUME FROM 3 X 2ML VIALS IN A PACK TO A 50ML BOTTLE.
P110043|S002|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2012|09/24/2012|||OK30|CHANGES TO THE EXTRUDED TUBING PROCESS.
P090022|S014|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|LENSTEC SOFTEC HD PCIOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2012|09/20/2012|||OK30|INCLUSION OF TWO ADDITIONAL STEAM STERILIZER UNITS FOR THE STERILIZATION OF THE FIRM'S SOFTEC SERIES OF IOLS.
P110019|S031|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/2012|11/20/2012|||APPR|APPROVAL TO CHANGE THE MANUFACTURING AND TESTING OF THE ACTIVE PHARMACEUTICAL INGREDIENT (API) USED IN THE MANUFACTURE OF THE DEVICE.
P970051|S096|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/2012|08/02/2013|||APPR|APPROVAL FOR THE NUCLEUS 6 COCHLEAR IMPLANT SYSTEM, A NEW SUITE OF EXTERNAL ACCESSORIES AND PROGRAMMING SOFTWARE TO BE USED WITH THE NUCLEUS 24 COCHLEAR IMPLANT, INCLUDING EXTERNAL SOUND PROCESSORS (CP910 AND CP920), USER REMOTE ASSISTANTS (CR210 AND CR230), INTRAOPERATIVE REMOTE ASSISTANT (CR220), AND PROGRAMMING SOFTWARE (CUSTOM SOUND SUITE 4 COMPRISED OF CUSTOM SOUND 4 AND CUSTOM SOUND EP 4).
P100021|S020|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2012|09/25/2012|||OK30|PROCESS CHANGE TO THE SPINDLE HYPOTUBE ASSEMBLY TO IMPROVE ITS ADHESIVE PROPERTIES.
P910023|S303|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ATLAS/ATLAS,ATLAS II/ATLAS II,CURRENT,CURRENT ACCEL,CURRENT,EPIC/EPIC,EPIC II/EPIC II,FORTIFY,FORTIFY ASSURA,ELLIPSE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2012|09/24/2012|||OK30|REDUCTION IN THE CURE TIME FOR THE ROOM TEMPERATURE VULCANIZED ADHESIVE.
P030054|S231|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2012|09/24/2012|||OK30|REDUCTION IN THE CURE TIME FOR THE ROOM TEMPERATURE VULCANIZED ADHESIVE.
P880086|S225|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2012|09/24/2012|||OK30|REDUCTION IN THE CURE TIME FOR THE ROOM TEMPERATURE VULCANIZED ADHESIVE.
P030035|S103|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER, FRONTIER II, ANTHEM FAMILY OF DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2012|09/24/2012|||OK30|REDUCTION IN THE CURE TIME FOR THE ROOM TEMPERATURE VULCANIZED ADHESIVE.
P890003|S258|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SYNERGYST,ELITE,MINUET,PRELUDE,THERA,PRODIGY,PREVA, J EWEL,AND REVEAL FAMILIES OF IPGS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2012|09/25/2012|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR.
P010031|S334|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO,MAXIMO,CONSULTA,INSYNC   SENTRY,MARQUIS,VIRTUOSO,SECURA,AND PROTECTA FAMILIES OF ICDS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2012|09/25/2012|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR.
P090013|S072|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI,AND ENRHYTHM MRI FAMILIES OF IPGS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2012|09/25/2012|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR.
P010015|S175|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|INSYNC,CONSULTA,AND SYNCRA FAMILIES OF IPGS|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2012|09/25/2012|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR.
P980035|S290|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|KAPPA,SIGMA,ADAPTA,SENSA,ADVISA,REVO MRI,ENRHYTHM MRI,RELIA,VERSA,AND ENPULSE FAMILIES OF IPGS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2012|09/25/2012|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR.
P080011|S017|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2012|09/27/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF RAW MATERIAL.
P860004|S175|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ASCENDA INTRATHECAL CATHETER|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2012|01/07/2013|||APPR|APPROVAL FOR A MINOR DESIGN CONTROL CHANGE, AND SUBSEQUENT MANUFACTURING PROCESS CHANGES, TO REMOVE THE LACK OF LAMINATION NOTE FROM THE PUMP AND SPINAL CATHETER SEGMENTS ASSEMBLY LEVEL PRINTS FOR THE DEVICE.
P980016|S381|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO,ENTRUST,MAXIMO,INTRINSIC,MARQUIS,CONCERTO,PROTECTA,SECURA,CONSULTA,GEM,AND ONYX FAMILIES OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/24/2012|09/25/2012|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR.
P960040|S269|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2012|09/24/2012|||OK30|UPDATE TO THE ACCEPTANCE ACTIVITIES FOR TAB LENGTH MEASUREMENT INSPECTION PROCESS.
P010012|S299|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2012|09/24/2012|||OK30|UPDATE TO THE ACCEPTANCE ACTIVITIES FOR TAB LENGTH MEASUREMENT INSPECTION PROCESS.
P960040|S270|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/2012|11/30/2012|||APPR|APPROVAL FOR SOFTWARE, FIRMWARE, AND HARDWARE ENHANCEMENTS AND MODIFICATIONS TO THE INCEPTA, ENERGEN, PUNCTUA, COGNIS, AND TELIGEN DEVICES.
P010012|S300|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/2012|11/30/2012|||APPR|APPROVAL FOR SOFTWARE, FIRMWARE, AND HARDWARE ENHANCEMENTS AND MODIFICATIONS TO THE INCEPTA, ENERGEN, PUNCTUA, COGNIS, AND TELIGEN DEVICES.
P050044|S023|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAPREP PLASMA SEPERATOR|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/2012|09/25/2012|||APPR|APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE LABELING INSTRUCTIONS FOR USE FOR THE VITAPREP PLASMA SEPARATOR: 1) INCLUSION OF WARNING STATEMENT: "ALWAYS WEAR WELL FITTING GLOVES WHEN HANDLING VITAPREP¿ AND 2) INCLUSION OF INSTRUCTIONS: "ASSURE THERE IS NO BLOOD IN THE LUER CONNECTION.  IF BLOOD IS PRESENT, CAREFULLY CLEAR THE AREA OF RESIDUAL BLOOD.¿
P090018|S018|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2012|09/28/2012|||OK30|CHANGE TO THE EAR INSERT TUBE CLEANING PROCESS.
P980023|S047|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2012|09/24/2012|||OK30|ADDING NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.
P010012|S301|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-D, LIVIAN CRT-D, CONTAK RENEWAL 3 RF HE CRT-D|LWP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/29/2012|01/18/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980022|S123|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN REAL-TIME MONITOR, MODEL CSS7100. CS7100K|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|08/30/2012|10/26/2012|||APPR|APPROVAL FOR MINOR SOFTWARE MODIFICATIONS IN GUARDIAN® REAL-TIME SYSTEM TO OPTIMIZE THE SHUTDOWN PROCEDURE FOR THE GUARDIAN MONITOR AND TO CORRECT AN ANOMALY THAT ALLOWED ACCESS OF OUT-OF-BOUNDS POINTER ERRORS.
P030017|S142|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2012|09/26/2012|||OK30|UPDATE THE TEST SYSTEMS USED FOR THE TESTING OF THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE DEVICE.
P050039|S011|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2012|09/27/2012|||OK30|ADDITION OF LASER MARKING SYSTEMS FOR PURPOSES OF THE PRODUCT IDENTIFICATION OF THE MATING FEMORAL STEMS USED WITH THE DEVICES.
P090013|S073|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN LEAD, 5086MRI|LWP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2012|10/04/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SINGAPORE OPERATION PTE, IN SINGAPORE..
P930039|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, 4076, CAPSUREFIX NOVUS LEAD, 5076|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2012|10/04/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SINGAPORE OPERATION PTE, IN SINGAPORE.
P100025|S002|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA)|OZA|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2012|05/23/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SHARP CORPORATION, IN ALLENTOWN, PA.
P110022|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/31/2012|12/20/2013|||APPR|APPROVAL FOR THE MIGRATION OF CLAIMS FROM THE FDA APPROVED ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM ON THE COBAS E 601 TO THE COBAS E 602 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM AND IS INDICATED FOR:ELECSYS ANTI-HBC LGM IMMUNOASSAYTHE ELECSYS ANTI-HBC LGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVEDETERMINATION OFIGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN, SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION.  THE PRESENCE OF ANTI-HBC IGM, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICALINFORMATION, IS INDICATIVE OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS ANTI-HBC LGM IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE COBAS E 601 AND COBAS E 602 IMMUNOASSAY ANALYZERS.  ELECSYS PRECICONTROL ANTI-HBC ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IGM IMMUNOASSAY ON THE COBAS E 601  ANDCOBAS E 602 IMMUNOASSAY ANALYZERS.
P960009|S156|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC DEEP BRAIN STIMULATION (DBS) THERAPY|MHY|NE|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/31/2012|09/13/2013|||APPR|APPROVAL FOR AN UPDATE TO YOUR LABELING.
P840062|S024|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2012|09/28/2012|||OK30|UPGRADES TO THE MEDICAL PRODUCTS MANUFACTURING SUITE.
P810006|S035|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2012|09/28/2012|||OK30|UPGRADES TO THE MEDICAL PRODUCTS MANUFACTURING SUITE.
P850010|S032|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2012|09/28/2012|||OK30|UPGRADES TO THE MEDICAL PRODUCTS MANUFACTURING SUITE.
P100027|S003|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER-2 DUAL DNA PROBE COCKTAIL|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2012|11/14/2012|||APPR|APPROVAL FOR IMPLEMENTING A CHANGE TO THE VENTANA REGENT DISPENSER SEAL FOR THE BENCHMARK AUTOMATED STAINING INSTRUMENTS.
P020055|S004|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2012|11/14/2012|||APPR|APPROVAL FOR IMPLEMENTING A CHANGE TO THE VENTANA REGENT DISPENSER SEAL FOR THE BENCHMARK AUTOMATED STAINING INSTRUMENTS.
P990081|S014|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER -2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2012|11/14/2012|||APPR|APPROVAL FOR IMPLEMENTING A CHANGE TO THE VENTANA REGENT DISPENSER SEAL FOR THE BENCHMARK AUTOMATED STAINING INSTRUMENTS.
P050044|S024|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/04/2012|||OK30|RELOCATE CERTAIN VITAGEL SURGICAL HEMOSTAT ASSEMBLY AND PACKAGING MANUFACTURING EQUIPMENT WITHIN THE CURRENT MANUFACTURING FACILITY.
P070006|S009|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT .TB TEST|OJN|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|06/12/2013|||APPR|APPROVAL FOR THE ADDITION OF A SECOND APPROVED SUPPLIER FOR THE CONJUGATED SECONDARY ANTIBODY
P100032|S007|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2012|12/19/2013|||APPR|APPROVAL FOR THE MIGRATION OF CLAIMS FROM THE FDA APPROVED ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC ON THE ELECSYS 2010 ANALYZER TO THE COBAS E 411 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC AND IS INDICATED FOR:ELECSYS ANTI-HBC IMMUNOASSAYTHE ELECSYS ANTI-HBC IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUM HEPARIN, SODIUM CITRATE, K2-EDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ELECSYS ANTI-HBC IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.  THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ELECSYS 2010 AND THE COBAS E 411 IMMUNOASSAY ANALYZERS.ELECSYS PRECICONTROL ANTI-HBC ELECSYS PRECICONTRO1 ANTI-HBC IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 AND THE COBAS E411 IMMUNOASSAY ANALYZERS.
P100031|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC TEST SYSTEM|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2012|12/20/2013|||APPR|APPROVAL FOR THE MIGRATION OF CLAIMS FROM THE FDA APPROVED ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC ON THE MODULAR ANALYTICS E170 TO THE COBAS E 601 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC AND IS INDICATED FOR:ELECSYS ANTI-HBC IMMUNOASSAY THE ELECSYS ANTI-HBC IMMUNOASSAY IS FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUMHEPARIN, SODIUM CITRATE, KREDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ELECSYS ANTI-HBC IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE MODULAR ANALYTICS E 170, COBAS E 60 I AND CO BAS E 602 IMMUNOASSAY ANALYZERS. ELECSYS PRECICONTROL ANTI-HBC ELECSYS PRECICONTROL ANTI-HBC IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYTICS E 170, COBAS E 60 I AND COBAS E 602 IMMUNOASSAY ANALYZERS.
P060008|S095|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACILITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice||N|09/04/2012|09/21/2012|||OK30|ALTERNATE EQUIPMENT FOR DISPENSING AND MIXING URETHANE ADHESIVE.
P040016|S096|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (MONORAIL)|MAF|CV|30-Day Notice||N|09/04/2012|09/21/2012|||OK30|ALTERNATE EQUIPMENT FOR DISPENSING AND MIXING URETHANE ADHESIVE.
P020009|S091|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM (MONORAIL)|MAF|CV|30-Day Notice||N|09/04/2012|09/21/2012|||OK30|ALTERNATE EQUIPMENT FOR DISPENSING AND MIXING URETHANE ADHESIVE.
P050050|S004|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)|NTG|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|05/01/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZRINSKI AG IN WURMLINGEN, GERMANY.
P020050|S009|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2012|02/21/2013|||APPR|APPROVAL FOR THE WAVELIGHT® ANALYZER II (MODEL NUMBER 1083), AN ACCESSORY TO THE ALLEGRETTO WAVE® EXCIMER LASER SYSTEM
P910073|S106|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE EZ IS-1 AND 4-SITE EZ QUADRIPOLAR ACTIVE FIXATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/03/2012|||OK30|CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.
P960006|S035|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND BIPOLAR ELUTING EXTENDABLE/RETRACTABLE PACING LEADS,MODELS 4086, 4087, 4088|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/03/2012|||OK30|CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.
P960004|S055|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE II AND FINELINE II STEROX LEADS AND FINELINE II EZ STEROX LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/03/2012|||OK30|CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.
P010012|S302|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2 LV-1, IS-1, 3 LV-1, 3 IS-1 LEFT VENTRICLAR HEART FAILURE LEADS, AND ACUITY SPIRAL LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/03/2012|||OK30|CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.
P050046|S016|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERALE LEADS MODELS: 4554, 4555|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/03/2012|||OK30|CHANGES TO THE DEXAMETHASONE ACETATE DRUG SUBSTANCE SPECIFICATION AND TESTING.
P990071|S020|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/17/2012|11/20/2012|||APPR|APPROVAL FOR SOFTWARE AND HARDWARE MODIFICATIONS IMPLEMENTED TO MAKE THE DEVICE COMPLIANT TO IEC 60601-1 3RD EDITION.
P830061|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALINE, VISTATRON EXCELLENCE PS+|NVY|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P010015|S176|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD, 4194 AND LEFT VENTRICULAR PACING LEAD, 4193|OJX|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P030036|S047|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD, 3830|NVY|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P100031|S009|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2012|08/12/2013|||APPR|APPROVAL FOR THE MIGRATION OF CLAIMS FROM THE FDA APPROVED ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC ON THE MODULAR ANALYTICS E170 TO THE COBAS E 602 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC AND IS INDICATED FOR:ELECSYS ANTI-HBC IMMUNOASSAYTHE ELECSYS ANTI-HBC IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUM HEPARIN, SODIUM CITRATE, K2-EDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHOMAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ELECSYS ANTI-HBC IMMUNOASSAYSPERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE MODULAR ANALYTICS E170 AND COBAS E 602 IMMUNOASSAY ANALYZERS. ELECSYS PRECICONTROL ANTI-HBC PRECICONTROL ANTI HBC IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI HBC IMMUNOASSAY ON THE MODULAR ANALYTICS E170 AND COBAS E 602 IMMUNOASSAY ANALYZERS.
P860057|S092|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/04/2012|||OK30|MANUFACTURING SOFTWARE CHANGE TO AUTOMATE IN-PROCESS LABELING.
P870056|S052|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/04/2012|||OK30|MANUFACTURING SOFTWARE CHANGE TO AUTOMATE IN-PROCESS LABELING.
P870077|S047|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/04/2012|||OK30|MANUFACTURING SOFTWARE CHANGE TO AUTOMATE IN-PROCESS LABELING.
P000007|S034|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/04/2012|||OK30|MANUFACTURING SOFTWARE CHANGE TO AUTOMATE IN-PROCESS LABELING.
P010041|S036|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2012|10/04/2012|||OK30|MANUFACTURING SOFTWARE CHANGE TO AUTOMATE IN-PROCESS LABELING.
P980016|S382|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC EVERA XT DR, EVERA XT VR, EVERA S DR, EVERA S VR IMPLANTABLE CARDIOVERTER DEFINRILLATORS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2012|04/03/2013|||APPR|APPROVAL FOR THE EVERA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P890003|S259|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2012|04/03/2013|||APPR|APPROVAL FOR THE EVERA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
P000025|S064|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL CONCERT IMPLANT|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2012|11/01/2012|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE STIMULATOR HOUSING COMPONENT OF THE MI1000 MED-EL CONCERT IMPLANT THAT IS INTENDED TO CORRECT AN ERROR OF DIMENSIONAL TOLERANCE OF THE HOUSING COMPONENTS USED IN THE MANUFACTURING OF THE DEVICES.
P980040|S041|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ITEC PRELOADED DELIVERY SYSTEM|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2012|08/21/2013|||APPR|APPROVAL FOR A CHANGE IN THE PACKAGING CONFIGURATION/ DELIVERY SYSTEM FOR THE TECNIS® 1-PIECE INTRAOCULAR LENS (IOL), MODEL ZCB00. THE NEW PACKAGING CONFIGURATION WILL FUNCTION AS BOTH THE PRIMARY PACKAGING FOR THE LENS AND AS A STERILE, DISPOSABLE INSERTION SYSTEM FOR DELIVERING THE LENS INTO THE EYE. THE TECNIS® 1-PIECE IOL (MODEL ZCB00) IN THE NEW PACKAGING CONFIGURATION/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODEL PCB00, AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P060039|S036|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD, 4195|NVY|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P950022|S083|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA DF-4 LEAD MODELS 7120Q, 7121Q, 7170Q, 7171Q, 7172Q|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2012|10/16/2012|||APPR|APPROVAL FOR CHANGES TO THE PACKAGING OF THE QUARTET IS4 AND DURATA DF4 LEADS.
P030054|S232|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUARTET IS4 LEAD MODELS 1458Q|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2012|10/16/2012|||APPR|APPROVAL FOR CHANGES TO THE PACKAGING OF THE QUARTET IS4 AND DURATA DF4 LEADS.
P950020|S054|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||FLEXTOME CUTTING BALLOON DILATATION DEVICE (MONORAIL & OVER-THE-WIRE)||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P930031|S035|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TRANSJUGULAR PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P980033|S024|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P940019|S030|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P060006|S033|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P060008|S096|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P050006|S031|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELIX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2090, HX2095|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/27/2012|||OK30|USE OF ALTERNATE CUTTING EQUIPMENT.
P080006|S044|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEADS|OJX|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P920015|S095|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO, SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P930039|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEADS|NVY|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P950024|S043|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P980050|S077|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD|LWS|CV|30-Day Notice||N|09/04/2012|10/03/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P090007|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON CABAS E 411|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|10/04/2012|||OK30|HARMONIZATION OF THE LYOPHILIZATION PROCESS FOR PEPTIDE MANUFACTURING.
P090008|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|10/04/2012|||OK30|HARMONIZATION OF THE LYOPHILIZATION PROCESS FOR PEPTIDE MANUFACTURING.
P090009|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|10/04/2012|||OK30|HARMONIZATION OF THE LYOPHILIZATION PROCESS FOR PEPTIDE MANUFACTURING.
P040016|S097|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX BARE MAETAL CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P100023|S054|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P110010|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P110035|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P020009|S092|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P920047|S053|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P020025|S035|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP TEMPERATURE ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2012|09/21/2012|||OK30|USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
P970004|S141|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY|EZW|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/06/2012|11/01/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P980035|S291|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR-IPG A4DR01|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2012|10/01/2012|||OK30|CHANGE TO THE HYBRID BURN-IN TIME.
P010015|S177|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, C4TR01, SYNCRA CRT-P C2TR01|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2012|10/01/2012|||OK30|CHANGE TO THE HYBRID BURN-IN TIME.
P850064|S021|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR, 203/203A|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/07/2012|05/16/2013|||APPR|APPROVAL FOR A CHANGE IN THE INSULATION MATERIAL ON THE RAW HEATER WIRE IN THE PATIENT CIRCUIT.
P910056|S013|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/2012|10/19/2012|||APPR|APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE (DFU) TO SPECIFY THAT THE ENVISTA MX60 LENS IS APPROVED FOR USE WITH THE MEDICEL ACCUJECT 2.2 (REV. 1) INJECTOR SET,OR OTHER INJECTOR SETS THAT SPECIFICALLY IDENTIFY THE ENVISTA MX60 LENS IN THE CLEARED LABELING.
P060008|S097|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|09/07/2012|05/01/2013|||APPR|APPROVAL FOR THE LABELING UPDATE FOR THE TAXUS LIBERTÉ PACLITAXEL-ELUTING CORONARY STENT SYSTEM.
P950037|S112|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA PACEMAKER FAMILY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2012|10/10/2012|||OK30|ADDITION OF SUPPLIERS FOR COMPONENTS USED IN THE DEVICES.
P980023|S048|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX LEAD FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2012|10/10/2012|||OK30|ADDITION OF SUPPLIERS FOR COMPONENTS USED IN THE DEVICES.
P860003|S066|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/10/2012|11/09/2012|||APPR|APPROVAL FOR THE ADDITION OF 8 RIBS TO THE NECK OF THE CENTRIFUGE BOWLS USED IN THE DEVICE AND FOR THE ACCOMPANYING PACKAGING CHANGES.
P870025|S011|GE MEDICAL SYSTEMS, INC.|4502 WOODLAND CORPORATE BLVD||TAMP|FL|33614||STIMULATOR, FETAL, ACOUSTIC|COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146|MCP|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/10/2012|10/10/2012|||APPR|
P050023|S055|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX ICD FAMILY|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2012|10/10/2012|||OK30|ADDITION OF SUPPLIERS FOR COMPONENTS USED IN THE DEVICES.
P070008|S034|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX LEAD FAMILY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2012|10/10/2012|||OK30|ADDITION OF SUPPLIERS FOR COMPONENTS USED IN THE DEVICES.
P960004|S056|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS AND ACCESSORIES|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2012|10/10/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE DISTAL TIP ELECTRODES.
P840001|S227|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EXTERNAL NEUROSTIMULATOR,ITREL4,ITREL4X,RESTORE PRIME,PRIMEADVANCED,RESTORE,RESTORE ULTRA,RESTORE ADVANCED & SENSOR|LGW|NE|30-Day Notice||N|09/10/2012|10/10/2012|||OK30|USE OF THE NEW AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER SOFTWARE RELEASE, INTERFACING WITH THE MANUFACTURING EXECUTION SYSTEM AT THE HYBRID COMPONENT SUPPLIER.
P960009|S157|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC, ACTIVA SC, ACTIVA RC IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice||N|09/10/2012|10/10/2012|||OK30|USE OF THE NEW AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER SOFTWARE RELEASE, INTERFACING WITH THE MANUFACTURING EXECUTION SYSTEM AT THE HYBRID COMPONENT SUPPLIER.
P970004|S142|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|NEUROSTIMULATOR IMPANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice||N|09/10/2012|10/10/2012|||OK30|USE OF THE NEW AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER SOFTWARE RELEASE, INTERFACING WITH THE MANUFACTURING EXECUTION SYSTEM AT THE HYBRID COMPONENT SUPPLIER.
P080025|S038|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice||N|09/10/2012|10/10/2012|||OK30|USE OF THE NEW AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER SOFTWARE RELEASE, INTERFACING WITH THE MANUFACTURING EXECUTION SYSTEM AT THE HYBRID COMPONENT SUPPLIER.
P980016|S383|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2012|10/04/2012|||OK30|UPDATE TO THE AUTOMATIC ASSEMBLY EQUIPMENT CONTROLLER (AAEC) SYSTEM.
P980035|S292|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2012|10/04/2012|||OK30|UPDATE TO THE AUTOMATIC ASSEMBLY EQUIPMENT CONTROLLER (AAEC) SYSTEM.
P010015|S178|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2012|10/04/2012|||OK30|UPDATE TO THE AUTOMATIC ASSEMBLY EQUIPMENT CONTROLLER (AAEC) SYSTEM.
P000053|S045|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2012|10/05/2012|||OK30|THE SILICON RECEIVING INSPECTION AND MILLING PROCESSES TO BE STREAMLINED AND TO REMOVE DUPLICATE TESTING TO PROVIDE CONSISTENCY FOR THE ENTIRE SILICONE PROCESSES.
P010020|S026|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICON NEOPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2012|10/05/2012|||OK30|THE SILICON RECEIVING INSPECTION AND MILLING PROCESSES TO BE STREAMLINED AND TO REMOVE DUPLICATE TESTING TO PROVIDE CONSISTENCY FOR THE ENTIRE SILICONE PROCESSES.
P960058|S098|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/10/2012|05/20/2013|||APPR|APPROVAL FOR AN ALTERNATE ELECTRODE CONFIGURATION FOR THE HIRES 90K ADVANTAGE COCHLEAR IMPLANT DEVICE, THE "HI FOCUS MID-SCALA ELECTRODE.
P010031|S335|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2012|10/04/2012|||OK30|UPDATE TO THE AUTOMATIC ASSEMBLY EQUIPMENT CONTROLLER (AAEC) SYSTEM.
P110019|S033|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2012|10/11/2012|||OK30|ADD AN ALTERNATE COMPRESSED GAS IN THE MANUFACTURING OF THE DEVICES.
P970051|S097|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/11/2012|11/09/2012|||APPR|APPROVAL TO INTRODUCE A REMOTE CONTROL (CR120) FOR USE WITH THENUCLEUS 5 (MODEL CP810) SOUND PROCESSOR FOR INTRAOPERATIVE USE TO CONDUCT IMPEDANCE AND AUTONRT, MEASUREMENTS THAT ARE COMMONLY USED DURING COCHLEAR IMPLANT SURGERY TO INDICATE THAT THE ELECTRODES ARE FUNCTIONING AND ARE STIMULATING NERVE TISSUE.
P960040|S271|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2012|10/05/2012|||OK30|CLEANING TOOL AID FOR THE SEALER HEATING PLATES.
P010012|S303|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2012|10/05/2012|||OK30|CLEANING TOOL AID FOR THE SEALER HEATING PLATES.
P030005|S087|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2012|10/05/2012|||OK30|CLEANING TOOL AID FOR THE SEALER HEATING PLATES.
P110007|S001|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|ABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2012|10/09/2012|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE SYRINGE AND CARTON ASSEMBLIES.
P030017|S143|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2012|10/11/2012|||OK30|PROCUREMENT OF A FUSE SUBASSEMBLY FROM A QUALIFIED SUPPLIER.
P110020|S006|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190|OWD|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/12/2012|01/10/2013|||APPR|APPROVAL FOR THE ADDITION OF POLY RA TO THE BRAF MUTANT AND WILD-TYPE CONTROLS BUFFER MATRIX AND ASSOCIATED MANUFACTURING PROCESS CHANGES.
P890003|S260|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/2012|09/05/2013|||APPR|APPROVAL FOR MULTIPLE DESIGN CHANGES, PACKAGING CHANGES, LABELING CHANGES, MANUFACTURING PROCESS CHANGES, AND A MANUFACTURING FACILITY TRANSFER TO TECHNICAL SERVICES FOR ELECTRONICS, INC., TSE TAIWAN MANUFACTURING FACILITY, WITH PACKAGING ACTIVITIES TO OCCUR AT THE TSE FACILITY IN JACKSON, MINNESOTA FOR THE 2090 EC/ECL ECG CABLE AND LEAD WIRES AND 148743 ECG PLUG.
P890055|S045|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM, 91-4200US, 91-4201US, 91-4205US|LKK|HO|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/13/2012|10/12/2012|||APPR|APPROVAL TO ADD GABLOFEN INTRATHECAL TO THE LIST OF APPROVED DRUGS IN THE INSTRUCTIONS FOR USE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDSTREAM PROGRAMMABLE INFUSION SYSTEM AND IS INDICATED FOR CHRONIC INTRATHECAL INFUSION OF BACLOFEN INJECTION STERILE SOLUTION IN THE TREATMENT OF SEVERE SPASTICITY.
P000012|S040|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|SCALE UP OF A BULK ENZYME USED IN THE MANUFACTURE OF KIT COMPONENTS.
P100013|S006|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/12/2012|||OK30|AN ALTERNATE TOOL FOR POSITIONING A COMPONENT AND THE ADDITION OF TWO OPTICAL SENSORS.
P060030|S029|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|SCALE UP OF A BULK ENZYME USED IN THE MANUFACTURE OF KIT COMPONENTS.
P100010|S019|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETERS|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGE IN THE OUTER BALLOON CURING FIXTURE AND PROCESS CHANGES.
P050028|S027|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|SCALE UP OF A BULK ENZYME USED IN THE MANUFACTURE OF KIT COMPONENTS.
P000008|S029|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/13/2012|11/09/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030005|S088|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) MODELS V172 AND V173|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/14/2012|03/12/2013|||APPR|APPROVAL FOR THE INVIVE MODELS V172, V173.
P950024|S044|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE EPI PACING LEADS|NVN|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|09/14/2012|11/27/2012|||APPR|APPROVAL TO ADD MODEL 4968 POST-APPROVAL STUDY RESULTS TO THE DEVICE LABELING.
P960013|S074|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P960030|S037|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|ISOFLEX P, ISOFLEX OPTIM, ISOFLEX S|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P950022|S084|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA, DURATA DF4|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P970013|S052|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P030035|S104|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, FRONTIER II|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P030054|S233|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKSITE, QUICKFLEX, QUICKFLEX MICRO, QUARTET, PROMOTE, PROMOTE+, PROMOTE RF, PROMOTE ACCEL, PROMOTE Q,PROMOTE QUADRA|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P880006|S083|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|REGENCY|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P880086|S226|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY, INTEGRITY, AFFINITY, VERITY, VICTORY, ZEPHYR, SUSTAIN, ACCENT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P910023|S304|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, EPIC/EPIC+, ATLAS/II/+|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2012|10/10/2012|||OK30|CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
P000025|S065|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM)|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2012|10/15/2012|||OK30|ADDITION OF A NEW LASER WELDING SYSTEM FOR THE PURPOSES OF WELDING IMPLANT HOUSINGS TO IMPLANT HEADERS FOR THE MI1000 MED-EL CONCERT MODEL COCHLEAR IMPLANTS.
P060007|S021|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2012|10/15/2012|||OK30|CHANGE IN TEST METHOD USED FOR THE DETERMINATION OF ANTIBODY ACTIVITY DURING MANUFACTURE.
P110029|S005|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2012|10/15/2012|||OK30|CHANGE IN TEST METHOD USED FOR THE DETERMINATION OF ANTIBODY ACTIVITY DURING MANUFACTURE.
P080011|S018|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (CONFILCON A) SOFT CONTACT LENSES|LPM|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2012|11/01/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOPERVISION CARIBBEAN CORPORATION IN JUANA DIAZ, PUERTO RICO.
P960040|S272|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA, ENERGEN, PUNCTUA IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2012|10/17/2012|||OK30|CHANGES TO THE FINAL HYBRID COMPONENT ELECTRIC TEST AND THE ADDITION OF NEW TEST EQUIPMENT.
P010012|S304|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN, PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH EVERGY DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2012|10/17/2012|||OK30|CHANGES TO THE FINAL HYBRID COMPONENT ELECTRIC TEST AND THE ADDITION OF NEW TEST EQUIPMENT.
P050039|S012|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2012|10/17/2012|||OK30|ADDITION OF A NEW SEALER.
P980022|S124|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CARELINK IPRO THERAPY MANAGEMENT SOFTWARE|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|09/18/2012|11/16/2012|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE CARELINK IPRO THERAPYMANAGEMENT SOFTWARE (MMT-7340) FROM VERSION 1.4 TO VERSION 1.5A. THE CARELINK IPRO THERAPY MANAGEMENT SOFTWARE (MMT-7340) IS A COMPONENT OF THE IPRO2 PROFESSIONAL CGM SYSTEM (MMT-7745).
P010030|S036|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2012|10/18/2012|||OK30|CHANGES TO THE BATTERY MANUFACTURING PROCESS AT THE SUPPLIER LOCATION.
P010013|S045|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2012|11/15/2012|||APPR|APPROVAL FOR A CHANGE TO FITTINGS IN THE SUCTION AND VACUUM FEEDBACK LINES AND MINOR LABELING CHANGES.
P090003|S016|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2012|10/12/2012|||OK30|ADDITION OF AN ALTERNATE ELECTROPOLISHING RECIPE.
P930021|S013|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|STRAUMANN ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115|NQA|DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2012|07/02/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDEON SCIENCE PARK, MALMO, SWEDEN.
P100001|S002|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2012|10/17/2012|||OK30|CHANGE TO THE MANUFACTURING PROCESS AND STORAGE CONDITIONS OF THE ANTIFOAM SOLUTION.
P890055|S046|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|09/20/2012|10/26/2012|||APPR|APPROVAL FOR A PACKAGING MODIFICATION TO THE DEVICE.
P100024|S003|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|09/20/2012|11/27/2012|||APPR|APPROVAL FOR A CHANGE IN THE MOUNTING MEDIUM REAGENT SUPPLIED IN THE KIT.
P030017|S144|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/20/2012|11/16/2012|||APPR|APPROVAL FOR A MATERIAL CHANGE FOR THE IMPLANTABLE PULSE GENERATOR (IPG) ANTENNA COIL FROM GOLD TO COPPER.
P050037|S034|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT 1.5CC, 8071M0, RADIESSE INJECTABLE IMPLANT 0.8 CC, 8069M0, RADIESSE INJECTABLE IMPLANT- 0.3C|LMH|SU|30-Day Notice||N|09/20/2012|10/17/2012|||OK30|ADDITION OF DEFECT CATEGORIES TO THE INCOMING INSPECTION PROCEDURES BASED ON RISK AND COMMENSURATE WITH SEVERITY.
P050052|S037|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT- 1.5CC, 8071M0, RADIESSE INJECTABLE IMPLANT-0.8CC, 8069M0, RADIESSE INJECTABLE IMPLANT-0.3CC|LMH|SU|30-Day Notice||N|09/20/2012|10/17/2012|||OK30|ADDITION OF DEFECT CATEGORIES TO THE INCOMING INSPECTION PROCEDURES BASED ON RISK AND COMMENSURATE WITH SEVERITY.
P850079|S057|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY XCEL TORIC XR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2012|10/17/2012|||OK30|MODIFY THE INSPECTION PROCESS.
P040047|S024|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10, COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10P|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2012|10/18/2012|||OK30|ADDITION OF DEFECT CATEGORIES TO AN EXISTING INCOMING INSPECTION PROCEDURE.
P090028|S003|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2012|10/17/2012|||OK30|CHANGE TO THE MANUFACTURING PROCESS AND STORAGE CONDITIONS OF THE ANTIFOAM SOLUTION.
P030036|S048|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT, 5867AS, SELECTSECURE LEAD, 3830|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2012|10/15/2012|||OK30|ALTERNATE SUPPLIERS FOR MOLDED COMPONENTS.
P920015|S096|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, 6935, 6935M, 6944, 6947, 6947M|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2012|10/15/2012|||OK30|ALTERNATE SUPPLIERS FOR MOLDED COMPONENTS.
P930039|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, 4076, 5076, VITATRON CRYSTALLINE LEADS, ICF09, ICQ09B|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2012|10/15/2012|||OK30|ALTERNATE SUPPLIERS FOR MOLDED COMPONENTS.
P980035|S293|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2012|10/15/2012|||OK30|ALTERNATE SUPPLIERS FOR MOLDED COMPONENTS.
P010015|S179|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD, 4194, LEFT VENTRICULAR PACING LEAD, 4193|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2012|10/15/2012|||OK30|ALTERNATE SUPPLIERS FOR MOLDED COMPONENTS.
P090013|S074|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD, 5086MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2012|10/15/2012|||OK30|ALTERNATE SUPPLIERS FOR MOLDED COMPONENTS.
P060039|S037|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD, 4195|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2012|10/15/2012|||OK30|ALTERNATE SUPPLIERS FOR MOLDED COMPONENTS.
P010047|S023|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL  AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2012|10/23/2012|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE MATERIALS COMPRISING THE OUTER POUCH, WHICH MAINTAINS THE STERILE BARRIER AND HOLDS THE APPLICATOR ACCESSORIES.
P050012|S049|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN CONTINUOUS GLUCOSE SYSTEM, DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2012|10/23/2012|||OK30|CHANGE TO A TORQUE DRIVER USED IN THE RECEIVER COMPONENT ASSEMBLY PROCESS OF THE DEVICE.
P960040|S273|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, TELIGEN, ENERGEN, AND INCEPTA ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2012|10/24/2012|||OK30|MOVE A COMPONENT COATING PROCESSES IN-HOUSE.
P010012|S305|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNTUA, COGNIS, ENERGEN, AND INCEPTA CRT-D'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2012|10/24/2012|||OK30|MOVE A COMPONENT COATING PROCESSES IN-HOUSE.
N16837|S010|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLEGEN VASCULAR GRAFT|LXA|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2012|02/25/2013|||APPR|APPROVAL FOR THE ADDITION OF MAVERICK BIOSCIENCES PTY LTD AS AN ALTERNATE SUPPLIER OR SOURCE OF THE BOVINE CAROTID ARTERY IN ARTEGRAFT COLLAGEN VASCULAR GRAFT.
P050012|S050|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|03/11/2013|||APPR|APPROVAL FOR A MODIFICATION OF THE TRANSMITTER TEXT APPLICATION METHOD FROM MACHINE ENGRAVING TO LASER MARKING.
P970004|S143|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|MANUFACTURE OF ONE INNER SEAL SILICONE COMPONENT AT THE ALTERNATE SUPPLIER, FLEXAN LOCATED IN SUZHOU INDUSTRIAL PARK, CHINA.
P080025|S039|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|MANUFACTURE OF ONE INNER SEAL SILICONE COMPONENT AT THE ALTERNATE SUPPLIER, FLEXAN LOCATED IN SUZHOU INDUSTRIAL PARK, CHINA.
P910077|S124|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 3120 ZOOM LATTITUDE PROGRAMMING SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|ALTERNATE COMPONENT SUPPLIERS.
P970053|S012|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EC-5000 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2012|12/12/2012|||APPR|APPROVAL FOR REPLACEMENT OF THE LASER DIODE FOR THE AIMING BEAM, THECORRESPONDING MODIFICATION OF THE AIMING BEAM OPTICAL SYSTEM, AND ASSOCIATED LABELING CHANGES.
P950005|S040|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUDING AND BRAIDING PROCESS.
P840001|S228|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, SYNERGY, SYNERGY VERSITREL, ITREL 4|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|MANUFACTURE OF ONE INNER SEAL SILICONE COMPONENT AT THE ALTERNATE SUPPLIER, FLEXAN LOCATED IN SUZHOU INDUSTRIAL PARK, CHINA.
P960009|S158|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SOLETRA, KINETRA, ACTIVA SC|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|MANUFACTURE OF ONE INNER SEAL SILICONE COMPONENT AT THE ALTERNATE SUPPLIER, FLEXAN LOCATED IN SUZHOU INDUSTRIAL PARK, CHINA.
P990025|S034|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVI-STAR CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUDING AND BRAIDING PROCESS.
P010068|S030|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS DS CATHETER AND NAVI-STAR DS CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUDING AND BRAIDING PROCESS.
P030031|S048|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2012|10/24/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUDING AND BRAIDING PROCESS.
P000053|S046|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/25/2012|11/13/2012|||APPR|APPROVAL FOR MINOR DESIGN CHANGE TO THE PUMP SHELL INTERFACE TOLERANCES.
P100023|S055|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2012|10/24/2012|||OK30|CHANGES TO WELD AND HEAT SHRINK REMOVAL PROCESS PARAMETERS.
P110010|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2012|10/24/2012|||OK30|CHANGES TO WELD AND HEAT SHRINK REMOVAL PROCESS PARAMETERS.
P060002|S028|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2012|10/04/2012|||APPR|APPROVAL FOR THE INCORPORATION OF A NEW LEICA DM2500M MICROSCOPE AND DFC295 DIGITAL CAMERA TO INCREASE IMAGE RESOLUTION IN ORDER TO MEASURE MATERIAL POROSITY IN ACCORDANCE WITH ISO 7198.
P010019|S034|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2012|10/25/2012|||OK30|MINOR MANUFACTURING CHANGE TO THE METHOD FOR THE MONITORING AND DATAPROCESSING FOR ALL PRODUCTION MODULES OF VARIOUS LENSES.
P030017|S145|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISON SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2012|11/19/2012|||APPR|APPROVAL FOR AN UPDATE TO THE CLINICIAN PROGRAMMER COMPUTER USED WITH THE DEVICE.  A TABLET COMPUTER FROM ASUS, MODEL EEE SLATE B121, WILL BE USED TO REPLACE THE CURRENT CLINICIAN PROGRAMMER (CP), A TOSHIBA MODEL M400 LAPTOP COMPUTER.
P050047|S028|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2012|10/25/2012|||OK30|CHANGE IN THE RESIDUAL CROSSLINKER ANALYSIS METHOD FOR THE DEVICE.
P060037|S020|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEM LPS-FLEX MOBILE AND LPS-MOBILE KNEES|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2012|03/28/2013|||APPR|APPROVAL FOR CHANGES TO AUTOMATE THE IN-PROCESS DYE PENETRANT TEST.
P860003|S067|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2012|11/19/2012|||APPR|APPROVAL FOR SOME MINOR CHANGES INTENDED TO REDUCE SPECULAR REFLECTION OF THE KT8L SENSOR'S LASER BEAM AND IMPROVE ITS OPTIC PATH (E.G., REMOVAL OF GLASS PORT, REMOVAL OF RESISTOR, AND ADDITION OF GASKET).
P000040|S025|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/24/2012|||OK30|SUPPLIER SITE CHANGE.
P030036|S049|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT, SELECTSECURE LEAD|NVY|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P010015|S180|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|AATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD|OJX|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P090013|S075|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P020022|S011|SIEMENS HEALTHCARE DIAGNOSTICS INC.|725 POTTER STREET||BERKELEY|CA|94710||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA 3.0 ASSAY (BDNA)|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/24/2012|||OK30|CHANGE IN MICROPLATE COATING EQUIPMENT FOR A COMPONENT, AND A CHANGE TO ADD AN INCOMING FUNCTIONAL TEST FOR A SUPPLIER COMPONENT.
P830061|S079|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEADS, VITATRON CRYSTALINE LEADS, VITATRON EXCELLENCE PS+ LEADS|NVY|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P980016|S384|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DF4CRT-D,MAXIMO II DF4 ICD,MAXIMO II ICD,PROTECTA DF4 ICD,PROTECTA ICD,PROTECTA XT DF4 ICD,PROTECTA XT ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2012|11/02/2012|||APPR|APPROVAL FOR AN UPDATE TO THE RAW MATERIAL OF THE CAPACITORS USED IN THE HIGH VOLTAGE DELIVERY CIRCUITRY.
P010031|S336|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,MAXIMO II CRT-D,MAXIMO II DF4 CRT-D,PROTECTA CRT-D,PROTECTA DF4 CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2012|11/02/2012|||APPR|APPROVAL FOR AN UPDATE TO THE RAW MATERIAL OF THE CAPACITORS USED IN THE HIGH VOLTAGE DELIVERY CIRCUITRY.
P910077|S125|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND VENTAK. MINI AUTOMATIC IMPLANTABLE CARDIOVERTER|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/24/2012|||OK30|CHANGE TO THE MAIN CONTROL BOARD MANUFACTURING LINE.
P100039|S002|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|09/28/2012|09/26/2013|||APPR|APPROVAL FOR THE AD VIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVEMATERIAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AD VIA CENTAUR ANTIHBS2(AHBS2) ASSAY, ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL, ANDADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL AND IS INDICATED FOR:ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY:  THE ADVIA CENTAUR ANTI-HBS2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEAND QUANTITATIVE DETENNINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA (EDTA, LITHIUM-HEPARINIZED, OR SODIUM-HEPARINIZED)AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAYRESULTS MAY BE USED AS AN AID IN THE DETENNINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW ADIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.THIS ASSAY HAS NOT BEEN FDA-CLEARED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS. ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL:  FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS2 ASSAY ON THE ADVIACENTAUR SYSTEMS. THE PERFORMANCE OF THE ANTI-HBS2 QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.ADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL:  THE ADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL (MCM) IS FOR IN VITRO USE IN THE VERIFICATION OF CALIBRATION AND REPORTABLE RANGE OF THE AD VIA CENTAUR AHBS2 ASSAY.
P930031|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/24/2012|||OK30|CHANGE TO THE AERATION CYCLE TIME FOR AN ETHYLENE OXIDE STERILIZATION CYCLE.
P850089|S090|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEADS, CAPSURE SP Z LEAD, CAPSURE Z NOVUSLEADS, IMPULSE II LEADS|NVY|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P890003|S261|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEADS|NVZ|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P920015|S097|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC LEAD, TUNNELLING TOOL|LWS|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P930039|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE|NVY|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P950024|S045|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P980050|S078|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD|LWS|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P080006|S045|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEADS|OJX|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P060039|S038|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice||N|09/28/2012|10/25/2012|||OK30|TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS.
P090003|S017|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/23/2012|||OK30|USE OF A NEW EXTRUSION DIE.
P960040|S274|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN IMPLANTABLE CARDIAC DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/24/2012|||OK30|SOFTWARE UPDATES FOR THE E2 AND FP (FINAL PACK) TESTS.
P940019|S031|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/24/2012|||OK30|CHANGE TO THE AERATION CYCLE TIME FOR AN ETHYLENE OXIDE STERILIZATION CYCLE.
P980033|S025|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/24/2012|||OK30|CHANGE TO THE AERATION CYCLE TIME FOR AN ETHYLENE OXIDE STERILIZATION CYCLE.
P910023|S306|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ATLAS/ATLAS+, ATLAS II/ATLAS 11+ CURRENT, CURRENT ACCEL, CURRENT+ EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY, FORTFY ASSURA,|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/31/2012|||OK30|ALTERNATE SUPPLIER OF THE SEPTUM COMPONENT.
P030054|S235|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS+HF, ATLAS II, HF, ATLAS II+ HF, EPIC + EPIC HF, EPIC + EPIC II HF, EPIC II + HF, PROMOTE, PROMOTE + PROMOTE RF, PR|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/31/2012|||OK30|ALTERNATE SUPPLIER OF THE SEPTUM COMPONENT.
P880086|S227|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DE PACERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/31/2012|||OK30|ALTERNATE SUPPLIER OF THE SEPTUM COMPONENT.
P030035|S105|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-PS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/31/2012|||OK30|ALTERNATE SUPPLIER OF THE SEPTUM COMPONENT.
P010012|S306|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/24/2012|||OK30|SOFTWARE UPDATES FOR THE E2 AND FP (FINAL PACK) TESTS.
P970020|S075|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ULTRA AND ZETA RX CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/23/2012|||OK30|MODIFICATION TO THE PYROGEN SAMPLING FREQUENCY.
P020047|S051|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION AND ML8 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/23/2012|||OK30|MODIFICATION TO THE PYROGEN SAMPLING FREQUENCY.
P070015|S101|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/23/2012|||OK30|MODIFICATION TO THE PYROGEN SAMPLING FREQUENCY.
P110019|S034|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2012|10/23/2012|||OK30|MODIFICATION TO THE PYROGEN SAMPLING FREQUENCY.
P070026|S008|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/28/2012|07/17/2013|||APPR|APPROVAL FOR THE ADDITION OF SUMMIT POROCOAT STEMS AS A COMPATIBLE COMPONENT TO THE EXISTING 28MM CERAMIC HEAD.
P070026|S009|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/28/2012|11/21/2012|||APPR|APPROVAL FOR ADDITION OF PINNACLE 300, MULTI-HOLE II AND SECTOR II ACETABULAR CUP COMPONENTS.
P910073|S107|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE 4-SITE DEFIBRILLATOR LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2012|12/20/2012|||APPR|APPROVAL FOR DRUG MATERIAL AND SUPPLIER CHANGES AS WELL AS DISTAL TIP DESIGN CHANGES.
P110043|S003|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYTEM|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|11/16/2012|||APPR|APPROVAL FOR AN E-BEAM STERILIZATION SITE LOCATED AT SYNERGY HEALTH IRELAND IN OFFALY, IRELAND.
P910073|S108|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2012|11/05/2012|||OK30|MODIFICATION OF THE LEAD TEST SOFTWARE.
P100010|S020|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC  FRONT CARDIAC CYROABLATION CATHETER,  ARCTIC  FRONT ADVANCE CARDIAC CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|11/07/2012|||OK30|USE OF AN AUTOMATIC PULL WIRE CRIMPER.
P080020|S003|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/01/2012|||OK30|REPLACEMENT OF AN EXISTING COLD STORAGE UNIT.
P100023|S056|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2012|11/05/2012|||OK30|MANUFACTURING SOFTWARE CHANGES PERTAINING TO THE CATHETERS.
P110010|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING  PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2012|11/05/2012|||OK30|MANUFACTURING SOFTWARE CHANGES PERTAINING TO THE CATHETERS.
P100042|S001|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/04/2012|07/15/2013|||APPR|APPROVAL FOR THE ADDITION OF THE PANTHER SYSTEM TO THE APTIMA® HPV ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV ASSAY. THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18, 31, 33, 35, 39, 45, 51, 52,56, 58, 59, 66, AND 68. THE APTIMA HPV ASSAY DOES NOT DISCRIMINATE BETWEEN THE 14 HIGH-RISK TYPES. CERVICAL SPECIMENS COLLECTED IN THINPREP PAP TEST VIALS CONTAINING PRESESRVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM. THE USE OF THE TEST IS INDICATED: 1) TO SCREEN WOMEN 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY; AND 2) IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV ASSAY CAN BE USED WITH CERVICAL CYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIANS ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.  BROOM-TYPE DEVICE (E.G., WALLACH PIPETTE) OR ENDOCERVICAL BRUSH/SPATULA.
P100044|S003|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL MINI SINUS IMPLANT, 6011|OWO|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/2012|11/09/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE STENT CRIMPER AND DELIVERY SYSTEMACCESSORY COMPONENTS OF THE DEVICE.
P960042|S042|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH|MFA|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2012|10/31/2012|||APPR|APPROVAL FOR MODIFYING THE SLS II AND GLIDELIGHT INSTRUCTION FOR USE MANUALS TO INCLUDE A WARNING AND PRECAUTION STATEMENT AND STRENGTHEN A WARNING.
P960040|S275|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PRIZM HE, VITALITY, VITALITY 2, CONFIENT, PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|11/07/2012|||OK30|ADDITIONAL PROCESS INSPECTION EQUIPMENT WITH SOFTWARE AND FIXTURE MODIFICATIONS.
P030005|S089|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR CRT-PS, CONTAK RENEWAL TR 2 CRT-PS, INVIVE CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|11/07/2012|||OK30|ADDITIONAL PROCESS INSPECTION EQUIPMENT WITH SOFTWARE AND FIXTURE MODIFICATIONS.
P010012|S307|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK RENEWAL 3 CRT-DS, CONTAK RENEWAL 3 HE CRT-DS, LIVIAN CRT-DS, PUNCTUA CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|11/07/2012|||OK30|ADDITIONAL PROCESS INSPECTION EQUIPMENT WITH SOFTWARE AND FIXTURE MODIFICATIONS.
P810032|S062|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA MULTI-PEICE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|10/31/2012|||OK30|CHANGE TO ADD A NEW STERILIZATION VENDOR.
P840060|S038|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PEICE POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|10/31/2012|||OK30|CHANGE TO ADD A NEW STERILIZATION VENDOR.
P880087|S020|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|10/31/2012|||OK30|CHANGE TO ADD A NEW STERILIZATION VENDOR.
P040020|S043|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACYSOF MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|10/31/2012|||OK30|CHANGE TO ADD A NEW STERILIZATION VENDOR.
P930014|S064|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF MONFOCAL AND ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES AND ACRYSERT DELIVERY SYSTEM|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|10/31/2012|||OK30|CHANGE TO ADD A NEW STERILIZATION VENDOR.
P980035|S294|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR SOFTWARE MODEL 9995|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2012|02/08/2013|||OK30|ADDITIONAL IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO, NEW PRESSURE TEST EQUIPMENT, NEW MANUFACTURING LINES IN AN EXTENDED CONTROLLED ENVIRONMENT AREA,CMOS PROCESS FLOW CHANGES, AN UPDATE TO TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS, THE IMPLEMENTATION OF FACTORYWORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1, ANDUPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.
P070015|S102|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/02/2012|||OK30|CHANGE TO SAMPLING FOR PYROGEN TESTING.
P110019|S035|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/02/2012|||OK30|CHANGE TO SAMPLING FOR PYROGEN TESTING.
P890003|S262|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A, AND MODEL 2491 DDMA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2012|02/08/2013|||OK30|ADDITIONAL IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO, NEW PRESSURE TEST EQUIPMENT, NEW MANUFACTURING LINES IN AN EXTENDED CONTROLLED ENVIRONMENT AREA,CMOS PROCESS FLOW CHANGES, AN UPDATE TO TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS, THE IMPLEMENTATION OF FACTORYWORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1, ANDUPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.
P970003|S153|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2012|10/30/2012|||OK30|CHANGE AND THE USE OF ALTERNATE COMPONENTS ON THE PRINTED CIRCUIT BOARD FOR THE PROGRAMMING WAND.
P970020|S076|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|ULTRA AND ZETA RX CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/02/2012|||OK30|CHANGE TO SAMPLING FOR PYROGEN TESTING.
P020047|S052|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION AND ML8 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/02/2012|||OK30|CHANGE TO SAMPLING FOR PYROGEN TESTING.
P030005|S090|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK & RENEWAL TR FAMILY, CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P830060|S073|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK , VENTAK PRIZM, ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P890061|S021|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRIZM 2 FAMILIES, ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P930035|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRIZM 2 FAMILIES, ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P840068|S051|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA, VISTA FAMILIES, PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P940031|S073|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES OF PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P050046|S017|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE FAMILY OF LV PACING LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P040050|S010|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS, MPQ-2.5|LNM|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/2012|12/28/2012|||APPR|APPROVAL TO QUALIFY AN ALTERNATIVE SILICONE ELASTOMER MATERIAL FOR THE MACROPLASTIQUE SYRINGE STOPPER, AS WELL AS AN ALTERNATIVE SUPPLIER OF THE SYRINGE STOPPER (NUSIL TECHNOLOGY, LLC AT CARPINTERIA, CA.)  THERE IS NO CHANGE TO THE INDICATIONS FOR USE OR LABELING OF THE MACROPLASTIQUE DEVICE.
P990012|S016|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2012|05/14/2013|||APPR|APPROVAL FOR A CHANGE TO THE SPECIFICATIONS FOR THE NEGATIVE HUMAN SERUM INCOMING MATERIAL.
P090003|S018|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice||N|10/03/2012|11/09/2012|||OK30|ADDITION OF AN ALTERNATE RESIN COMPOUNDER.
P010012|S308|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD, LIVIAN, COGNIS FAMILIES OF CRT-DS; EASYTRAK, ACUITY SPRIAL FAMILIES OF LV PACING LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P950001|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE LEAD FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P910077|S126|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX/VENTAK MINI FAMILIES OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P960040|S276|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, LIVIAN, & TELIGEN FAMILIES OF ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P910073|S109|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK FAMILY OF ICD LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P940008|S030|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q FAMILY OF ICD/ICD LEADS, RES-Q MICRON FAMILY OF ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P960006|S036|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND FAMILIES OF PACING LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P960004|S057|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE/FINELINE FAMILIES OF PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2012|11/09/2012|||OK30|SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
P870072|S050|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/2012|12/27/2012|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE TLC-II PORTABLE VAD BATTERY PACK.
P060033|S072|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2012|11/20/2012|||OK30|CHANGES TO THE ORIENTATION OF THE STERILIZATION CARTONS, LOCATION OF THE INTERNAL PROCESS CHALLENGE DEVICES, AND MODIFICATIONS TO THE EXTERNAL PROCESS CHALLENGE DEVICES USED DURING STERILIZATION.
P100027|S004|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2012|11/21/2012|||APPR|APPROVAL FOR THE CHANGE OF THE TWO LITER (2L) BOTTLES FOR EACH OF THE AQUEOUS-BASED REAGENTS FROM FLUORINATED TO NON-FLUORINATED BOTTLES.
P860004|S176|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II, 8637|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/02/2012|||OK30|CHANGE IN THE RECEIVING INSPECTION METHOD USED ON THE COATED CATHODE CURRENT COLLECTOR.
P970004|S144|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II, 3058|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/02/2012|||OK30|CHANGE IN THE RECEIVING INSPECTION METHOD USED ON THE COATED CATHODE CURRENT COLLECTOR.
P960009|S159|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC, 37602 AND 37603|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/02/2012|||OK30|CHANGE IN THE RECEIVING INSPECTION METHOD USED ON THE COATED CATHODE CURRENT COLLECTOR.
P870076|S013|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING CAND AND APPLICATOR SYSTEMS|KNH|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/04/2012|10/26/2012|||APPR|APPROVAL FOR LABELING CHANGES INCLUDING ADDING/ MODIFYING WARNINGS IN THE INSTRUCTION FOR USE, UPDATING COMPANY BRANDING, AND SEPARATING THE QUICK REFERENCE GUIDES FOR THE REUSABLE AND DISPOSABLE APPLICATORS.
P050039|S013|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/01/2012|||OK30|ADDITION OF A NEW BLAST CABINET.
P060038|S015|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/20/2012|||OK30|TRANSFER OF COMPONENT SECONDARY OPERATIONS FROM SUPPLIER TO IN-HOUSE.
P080026|S004|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/01/2012|||OK30|CHANGE TO THE EQUIPMENT UTILIZED FOR IDENTITY TESTING OF OLIGONUCLEOTIDES.
P100017|S003|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/01/2012|||OK30|CHANGE TO THE EQUIPMENT UTILIZED FOR IDENTITY TESTING OF OLIGONUCLEOTIDES.
P830037|S054|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|EXTENDED WEAR SOFT CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/08/2012|||OK30|CHANGE TO THE PRODUCTION OF CASTING CUPS.
P020004|S075|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/04/2012|11/20/2012|||APPR|APPROVAL FOR THE MODIFICATION OF THE DELIVERY SYSTEM FOR THE FOLLOWING DEVICE COMPONENTS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS ON THE SIM-PULL (ORIGINAL) AND C3 (EMDS) CATHETERS IN ORDER TO LOWER THEIR DELIVERY PROFILES AS OUTLINED BELOW:  1) 16, 18 AND 20 MM CONTRALATERAL LEGS FROM 18 FR TO 12 FR; 2) 23 MM CONTRALATERAL LEG FROM 18 FR TO 14 FR; 3) 27 MM COLATERAL LEG FROM 18 FR TO 15 FR; 4) 23, 26, 28.5 MM AORTIC EXTENDERS FROM 18 FR TO 16 FR; 5) 32 MM AORTIC EXTENDER FROM 20 FR TO 17 FR; 6) 31 MM TRUNK-IPSILATERAL LEG WITH SIM-PULL DELIVERY SYSTEM FROM 20 FR TO 18 FR AND 7) 31 MM TRUNK-IPSILATERAL LEG WITH C3 DELIVERY SYSTEM FROM 20 FR TO 18 FR.
P840001|S229|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|INTREL 4, 37703 AND 37704|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/02/2012|||OK30|CHANGE IN THE RECEIVING INSPECTION METHOD USED ON THE COATED CATHODE CURRENT COLLECTOR.
P080025|S040|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II 3058|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/02/2012|||OK30|CHANGE IN THE RECEIVING INSPECTION METHOD USED ON THE COATED CATHODE CURRENT COLLECTOR.
P990012|S017|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/02/2012|||OK30|CHANGE TO THE LYOPHILIZATION PROCESS FOR COMPONENTS OF THE ASSAY.
P990012|S018|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2012|11/02/2012|||OK30|CHANGE TO THE FUNCTIONAL TEST PROCEDURE OF AN ASSAY COMPONENT.
P000020|S016|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|BARD ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2012|11/13/2012|||OK30|CHANGES TO THE ELECTRICAL TESTER AND BARCODE SCANNER.
P980035|S295|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2012|10/31/2012|||OK30|ELIMINATION OF THE INCOMING INSPECTION OF A BATTERY COMPONENT AT AN INTERNAL SUPPLIER LOCATION.
P090013|S076|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2012|10/31/2012|||OK30|ELIMINATION OF THE INCOMING INSPECTION OF A BATTERY COMPONENT AT AN INTERNAL SUPPLIER LOCATION.
P010015|S181|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2012|10/31/2012|||OK30|ELIMINATION OF THE INCOMING INSPECTION OF A BATTERY COMPONENT AT AN INTERNAL SUPPLIER LOCATION.
P010038|S017|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|SECONDLOOK DIGITAL|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/05/2012|06/19/2013|||APPR|APPROVAL OF SECONDLOOK V7.2 CAD FOR USE WITH THE FUJI ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM
P910073|S110|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACUITY SPIRAL|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/07/2012|||OK30|UPDATES TO TEST METHODS FOR STEROID ELUTING LEADS.
P010012|S309|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RELIANCE IS-1 (PASSIVE) DEFIBRILLATION LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/07/2012|||OK30|UPDATES TO TEST METHODS FOR STEROID ELUTING LEADS.
P960040|S277|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ICD MODELS, INCEPTA E-160, E-161, E162, E163, ENERGEN E140, E141, E142, E143, PUNCTUA E050, E050, E051, E052, E053|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/05/2012|||OK30|CHANGE TO THE SPOT-WELD PROCESS.
P110023|S004|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/07/2012|||OK30|ALTERNATE MICROBLASTER.
P060001|S018|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/07/2012|||OK30|ALTERNATE MICROBLASTER.
P850079|S058|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY XCEL TONIC XR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/08/2012|||OK30|CHANGE IN THE MANUFACTURING REMAKE PROCESS.
P980016|S386|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II CRT-D, MAXIMO II ICD, MAXIMO II ICD, PROTECTA ICD AND PROTECTA XT ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/07/2012|||OK30|Approval for 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
P010031|S338|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D. PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/07/2012|||OK30|Approval for 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
P050006|S032|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2030, HX2035|MLV|CV|30-Day Notice||N|10/09/2012|11/07/2012|||OK30|ADDITION OF A SUPPLIER FOR POLYVINYL ALCOHOL (PVA).
P010012|S310|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CRT-D MODELS: INCEPTA N160, N161, N164, ENERGEN N140, N141, PUNCTUA N050|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/05/2012|||OK30|CHANGE TO THE SPOT-WELD PROCESS.
P100020|S007|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/06/2012|||OK30|CHANGE OF RESIN FOR CLOSURES, AND AN ADDITION OF NEW FILLING AND CAPPING EQUIPMENT.
P850079|S059|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2012|11/08/2012|||OK30|DECREASE IN HYDRATION TIME ON AUTOMATED WET LINE (AWL) SYSTEMS.
P090016|S003|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE DERMAL FILTER|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/10/2012|12/07/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950020|S055|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|FLEXTONE CUTTING BALLOON, H7493BM3XXXXX, H749CBO3XXXXX|NWX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/10/2012|06/28/2013|||APPR|APPROVAL FOR DIRECTIONS FOR USE (DFU) LABELING MODIFICATIONS.
P040008|S003|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA|MTF|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/2012|01/18/2013|||APPR|APPROVAL FOR UPDATING THE PACKAGING INSERT BY DEFINING THE PHRASE "INSTRUMENT OF THE VIDAS FAMILY" AS "INSTRUMENT OF THE VIDAS FAMILY: VIDAS OR MINIVIDAS"AND REPLACING "INSTRUMENTS OF THE VIDAS FAMILY" WITH "VIDAS INSTRUMENTS" IN THE INTENDED USE. THE DEVICE, VIDAS® TOTAL PSA, IS INTENDED FOR USE WITH THE VIDAS INSTRUMENTS (VITEK® IMMUNODIAGNOSTIC ASSAY SYSTEM) AS AN AUTOMATED ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA) FOR THE QUANTITATIVE MEASUREMENT OFTOTAL PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM. THE VIDAS TPSA ASSAY IS INDICATED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATE CANCER AND AS AN AID IN THE DETECTION OF PROSTATE CANCER IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (ORE) IN MEN AGE 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER. THE DEVICE, VIDAS® FREE PSA RT, IS AN AUTOMATED QUANTITATIVE TEST FOR USE ON THE VIDAS INSTRUMENTS, FOR THE QUANTITATIVE MEASUREMENT OF THE FREE FRACTION OF  PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ELF A TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). THE VIDAS FREE PSA RT IS INTENDED TO BE USED IN CONJUNCTION WITH THE VIDAS TPSA ASSAY IN MEN AGE 50 YEARS OR OLDER WHO HAVE DIGITAL RECTAL EXAMINATION (ORE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND VIDAS TPSA VALUES BETWEEN 4 AND 10 NG/ML TO DETERMINE THE % FREE PSA VALUE. THE VIDAS % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER.
P080008|S002|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|VIDAS FREE PSA RT|MTG|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/2012|01/18/2013|||APPR|APPROVAL FOR UPDATING THE PACKAGING INSERT BY DEFINING THE PHRASE"INSTRUMENT OF THE VIDAS FAMILY" AS "INSTRUMENT OF THE VIDAS FAMILY: VIDAS OR MINIVIDAS"AND REPLACING "INSTRUMENTS OF THE VIDAS FAMILY" WITH "VIDAS INSTRUMENTS" IN THEINTENDED USE. THE DEVICE, VIDAS® TOTAL PSA, IS INTENDED FOR USE WITH THE VIDAS INSTRUMENTS(VITEK® IMMUNODIAGNOSTIC ASSAY SYSTEM) AS AN AUTOMATED ENZYME-LINKED FLUORESCENTIMMUNOASSAY (ELFA) FOR THE QUANTITATIVE MEASUREMENT OFTOTAL PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM. THE VIDAS TPSA ASSAY IS INDICATED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATE CANCER AND AS AN AID IN THE DETECTION OF PROSTATE CANCER IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (ORE) IN MEN AGE 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER. THE DEVICE, VIDAS® FREE PSA RT, IS AN AUTOMATED QUANTITATIVE TEST FOR USE ON THE VIDAS INSTRUMENTS, FOR THE QUANTITATIVE MEASUREMENT OF THE FREE FRACTION OF  PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ELF A TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). THE VIDAS FREE PSA RT IS INTENDED TO BE USED IN CONJUNCTION WITH THE VIDAS TPSA ASSAY IN MEN AGE 50 YEARS OR OLDER WHO HAVE DIGITAL RECTAL EXAMINATION (ORE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND VIDAS TPSA VALUES BETWEEN 4 AND 10 NG/ML TO DETERMINE THE % FREE PSA VALUE. THE VIDAS % FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER.
P080032|S010|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/11/2012|11/09/2012|||APPR|APPROVAL FOR LABELING CHANGES TO THE ALAIR CATHETER MODEL ATS 2-5 DIRECTIONS FOR USE (DFU), ALAIR RADIOFREQUENCY (RF) CONTROLLER MODEL ATS 200 OPERATOR'S MANUAL, AND ALAIR BRONCHIAL THERMOPLASTY SYSTEM PATIENT BROCHURE.
P960009|S160|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA, SOLETRA|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2012|12/17/2012|||APPR|APPROVAL FOR MINOR CHANGES TO MODEL 8840 NVISION PROGRAMMER SOFTWARE FOR END OF SERVICE AND LOW/ EMPTY RESERVOIR ALARMS.
P010047|S024|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/11/2012|12/07/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P080012|S009|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2012|11/06/2012|||OK30|USE OF AN ALTERNATE SOLDER PASTE DURING THE MANUFACTURE OF THE DEVICE.
P960040|S278|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2012|11/05/2012|||OK30|NEW REWORK PROCESS FOR COMPONENTS IN THE HEADER.
P010012|S311|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2012|11/05/2012|||OK30|NEW REWORK PROCESS FOR COMPONENTS IN THE HEADER.
P100027|S005|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/10/2012|03/26/2013|||APPR|APPROVAL FOR HARDWARE MODIFICATION AND SOFTWARE UPGRADES TO THE BENCHMARK, ULTRA INSTRUMENT. THE PURPOSE OFTHESE DESIGN CHANGES WAS TO IMPLEMENT ULTIMATE REAGENT ACCESS (URA) FEATURE ON THE BENCHMARK ULTRA INSTRUMENT.
P860004|S177|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEMS, SYNCHROMED, SYNCHROMED II, SYNCHROMED EL|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2012|12/17/2012|||APPR|APPROVAL FOR MINOR CHANGES TO MODEL 8840 N'VISION PROGRAMMERSOFTWARE FOR END OF SERVICE AND LOW/EMPTY RESERVOIR ALARMS AND IS INDICATED FOR USE WITH SYNCHROMED EL AND SYNCHROMED II PUMPS.
P840001|S230|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 3, ITREL 4, SYNERGY, SYNERGY VERSITREL, RESTORE, RESTOREPRIME, ADVANCEDRESTORE, ULTRA, ENS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|10/05/2012|12/17/2012|||APPR|APPROVAL FOR MINOR CHANGES TO MODEL 8840 NVISION PROGRAMMER SOFTWARE FOR END OF SERVICE AND LOW/ EMPTY RESERVOIR ALARMS.
P010012|S312|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA CRT-D, ENERGEN CRT-D, PUNCTUA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2012|11/07/2012|||OK30|ADDITION OF PLASMA CLEANING STEPS AT A SUPPLIER.
P960040|S279|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2012|11/07/2012|||OK30|ADDITION OF PLASMA CLEANING STEPS AT A SUPPLIER.
P890003|S263|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK 2290|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/11/2012|12/11/2012|||APPR|APPROVAL OF AN UPDATE TO THE 2290 ANALYZER SOFTWARE.
P100021|S021|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT II AUI STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/2012|04/16/2013|||APPR|APPROVAL FOR THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT SYSTEM, A LINE EXTENSION TO THE CURRENT ENDURANT II STENT GRAFT SYSTEM.  THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME ENDURANT II STENT GRAFT SYSTEM. THE ENDURANT II BIFURCATED STENTGRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS.  THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT IS INDICATED FOR THE ENDOVASCULARTREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS IN PATIENTS WHOSE ANATOMY DOES NOT ALLOW THE USE OF A BIFURCATED STENT GRAFT. THE ENDURANT II STENT GRAFT SYSTEM IS INDICATED FOR USE IN PATIENTS WITH THE FOLLOWING CHARACTERISTICS:1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; 2) PROXIMAL NECK LENGTH OF  ¿ 10MM; 3)INFRARENAL NECK ANGULATION OF  ¿ 60°; 4) AORTIC NECK DIAMETERS WITH A RANGE OF 19 TO 32MM; 5) DISTAL FIXATION LENGTH(S) OF ¿ 15 MM; 6) ILIAC DIAMETERS WITH A RANGE OF 8 TO 25MM; AND 7) MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR.
P020009|S093|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS AND EXPRESS CORONARY  STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2012|11/07/2012|||OK30|REPLACE THE COMPONENT VERIFICATION SYSTEM.
P040016|S098|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2012|11/07/2012|||OK30|REPLACE THE COMPONENT VERIFICATION SYSTEM.
P060006|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2012|11/07/2012|||OK30|REPLACE THE COMPONENT VERIFICATION SYSTEM.
P110035|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2012|11/07/2012|||OK30|REPLACE THE COMPONENT VERIFICATION SYSTEM.
P910077|S127|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE G2 COMMUNICATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2012|11/07/2012|||OK30|ALTERNATE SURFACE MOUNT TECHNOLOGY MANUFACTURING LINE AT THE CONTRACT MANUFACTURER.
P100025|S003|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)|OZA|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/12/2012|11/06/2012|||APPR|APPROVAL FOR A LABELING CHANGE TO ENHANCE THE SAFE USE OF THE DEVICE.
P860057|S093|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2012|11/13/2012|||OK30|UPGRADES TO THE TISSUE TREATMENT UNITS.
P100041|S015|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2012|11/13/2012|||OK30|UPGRADES TO THE TISSUE TREATMENT UNITS.
P910077|S128|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE/PROGRAMMER/RECORDER/MONITOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2012|11/14/2012|||OK30|MOVING PRODUCTION OF VARIOUS PRINTED CIRCUIT BOARD ASSEMBLIES TO NEW MANUFACTURING LINES AND AN ALTERNATE WATER WASH SYSTEM AT A SUPPLIER LOCATION.
P110028|S005|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2012|11/14/2012|||OK30|MODIFY THE STENT SUBASSEMBLY EXPANSION PROCESS.
P110003|S002|GENZYME CORP.|500 KENDALL STREET||CAMBRIDGE|MA|02142|1562|Occluder, internal vessel, temporary|LEGOO ENDOVASCULAR OCCLUSION GEL|OBC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2012|11/13/2012|||OK30|CHANGES TO THE PACKAGING CONFIGURATIONS OF THE DEVICE.
P910023|S307|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|MERLIN HOME 6.1M|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/2012|12/19/2012|||APPR|APPROVAL FOR THE EX2000 SOFTWARE VERSION 6.1 M FOR MARLIN@HOME WITHOUT THE CELLULAR ADAPTER AND SOFTWARE VERSION 6.0 FOR MERLIN.NET SYSTEM.
P030054|S237|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MERLIN NET 6.1M|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/2012|12/19/2012|||APPR|APPROVAL FOR THE EX2000 SOFTWARE VERSION 6.1 M FOR MARLIN@HOME WITHOUT THE CELLULAR ADAPTER.
P030054|S236|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRIPOLAR PACING PAS (QUAD PAS)|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/15/2012|02/15/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050023|S056|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Drug eluting permanent left ventricular (lv) pacemaker electrode|COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD|OJX|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|10/12/2012|01/11/2013|||APPR|APPROVAL FOR UPDATING THE LABELING FOR THE COROX FAMILY OVER THE WIRE (OTW) LEFT VENTRICULAR (LV) PACING LEAD TO REFLECT THE FINDINGS OF THE COROX OTW STEROID LV MONITORING (COSMO) POST-APPROVAL STUDY.
P020009|S094|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|10/15/2012|10/31/2012|||OK30|ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
P910073|S111|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE IS-4 DEFIBRILLATION LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2012|11/14/2012|||OK30|CHANGE IN THE REWORK PROCESS TO THE LEAD TERMINAL ASSEMBLY PROCESS.
P040011|S002|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry antibody assay, c-kit|C-KIT PHARMDX|NKF|PA|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/16/2012|11/02/2012|||APPR|APPROVAL FOR CHANGING THE COMPANY PREFIX TO THE DEVICE NAME (FROM DAKOCYTOMATION C-KIT PHARMDX  TO C-KIT PHARMDX).  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME C-KIT PHARMDX.
P040016|S099|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|10/15/2012|10/31/2012|||OK30|ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
P060006|S035|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice||N|10/15/2012|10/31/2012|||OK30|ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
P060008|S098|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|10/15/2012|10/31/2012|||OK30|ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
P940019|S032|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT REDUCED PROFILE STENT SYSTEM|MAF|CV|30-Day Notice||N|10/15/2012|10/31/2012|||OK30|ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
P980033|S026|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDO (VENOUS) STENT SYTEM|MAF|CV|30-Day Notice||N|10/15/2012|10/31/2012|||OK30|ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
P930031|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT ENDO (TIPS) STENT SYSTEM|MIR|CV|30-Day Notice||N|10/15/2012|10/31/2012|||OK30|ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
P010032|S063|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/15/2012|04/11/2013|||APPR|APPROVAL FOR REPLACING THE CURRENT CONTRAINDICATION REGARDING USE OF THENEUROSTIMULATOR IN PATIENTS WITH DEMAND-TYPE CARDIAC PACEMAKERS WITH A WARNING STATEMENT THAT RECOMMENDS INTERACTION TESTING AND AVOIDING UNIPOLAR PROGRAMMING OF THE NEUROSTIMULATOR.
P000040|S026|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|10/17/2012|01/11/2013|||APPR|APPROVAL TO REPLACE OBSOLETE COMPONENTS IN THE CONTROL UNIT AND MAKE CHANGES TO OTHER COMPONENTS TO ACCOMMODATE THESE NEW PARTS.
P000044|S030|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS  HBSAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|11/13/2012|||OK30|MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
P950020|S056|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CORONARY FLEXTOME CUTTING BALLOON||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|10/31/2012|||OK30|A SECOND PROXIMAL BOND LASER AND SEVERAL PROCESS CHANGES TO THE AUTOMATIC TORCH BOX.
P830061|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE, VITATRON CRYSTALINE, VITATRON EXCELLENCE PS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|10/26/2012|||OK30|NEW ANNEALING VACUUM OVEN.
P830055|S128|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|11/19/2012|||APPR|APPROVAL FOR AN ADDITIONAL RINSE STEP BEING IMPLEMENTED IN THE MANUFACTURING PROCESS FOR THE MBT CEMENTED AND POROUS TRAYS AND THE ATTUNE RP TIBIAL BASE.
P010047|S026|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/20/2012|07/25/2013|||APPR|APPROVAL FOR A CHANGE IN THE SHIPPING TEMPERATURE RANGE TO 1ºC TO 30°C TO ALLOW FOR BRIEF POSSIBLE EXTREMES IN TEMPERATURE DURING SHIPMENT. THE AGENCY NOTES THAT THE "KEEP REFRIGERATED" LABEL, C-00473, WILL BE AFFIXED TO THE SHIPPING CONTAINER.
P010030|S037|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/18/2012|12/20/2012|||APPR|APPROVAL FOR A MINOR CHANGE IN SOFTWARE/FIRMWARE FOR YOUR LIFEVESTWEARABLE DEFIBRILLATOR (WCD 4000) DEVICE TO SUPPORT TWO FDA APPROVED ACCELEROMETERS. THE SOFTWARE/FIRMWARE CHANGE ENABLES THE SUBJECT DEVICE TO DETECT BETWEEN THE ACCELEROMETERS, TO CALIBRATE THE ACCELEROMETER AND ADJUST FOR ACCELEROMETER OUTPUT POLARITY.
P010021|S023|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|11/13/2012|||OK30|MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
P030026|S026|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS ANTI-HBC IGM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|11/13/2012|||OK30|MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
P000014|S026|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS ANTI-HBS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|11/13/2012|||OK30|MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
P030024|S020|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS ANTI-HBC|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|11/13/2012|||OK30|MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
P980035|S296|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/19/2012|12/11/2012|||APPR|APPROVAL FOR AN UPDATE TO A CAPACITOR.
P100001|S003|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS ANTI-HBE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2012|11/13/2012|||OK30|MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
P060031|S006|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/13/2012|||OK30|CHANGE TO AUTOMATE THE FILLING AND CAPPING PROCESS FOR COMPONENTS IN THE DEVICES.
P060034|S006|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC IGM EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/13/2012|||OK30|CHANGE TO AUTOMATE THE FILLING AND CAPPING PROCESS FOR COMPONENTS IN THE DEVICES.
P050048|S008|BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBS EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/13/2012|||OK30|CHANGE TO AUTOMATE THE FILLING AND CAPPING PROCESS FOR COMPONENTS IN THE DEVICES.
P890003|S264|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/16/2012|||OK30|IMPLEMENTATION OF A NEW CLEANING PROCESS AND A CURING OVEN.
P980016|S387|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUSTICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/16/2012|||OK30|IMPLEMENTATION OF A NEW CLEANING PROCESS AND A CURING OVEN.
P110038|S001|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/19/2012|12/18/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P100021|S022|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/20/2012|||OK30|REDUCTION TO THE INCOMING INSPECTION FOR A COMPONENT ASSEMBLY.
P970029|S022|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM|MNO|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/19/2012|12/18/2012|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P980035|S297|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,ADAPTA L,ADAPTA S,SENSIA L,SENSIA,VERSA IPG,ADVISA DR IPG,ENRHYTHM IPG,RELIA,SIGMA DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/16/2012|||OK30|IMPLEMENTATION OF A NEW CLEANING PROCESS AND A CURING OVEN.
P090013|S077|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/16/2012|||OK30|IMPLEMENTATION OF A NEW CLEANING PROCESS AND A CURING OVEN.
P010031|S339|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/16/2012|||OK30|IMPLEMENTATION OF A NEW CLEANING PROCESS AND A CURING OVEN.
P110003|S003|GENZYME CORP.|500 KENDALL STREET||CAMBRIDGE|MA|02142|1562|Occluder, internal vessel, temporary|LEGOO|OBC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2012|11/13/2012|||OK30|CHANGES TO THE PACKAGING CONFIGURATIONS BY REDUCING THE NUMBER OF TYVEK POUCHED CANNULAE PER SALES CARTON.
P860057|S094|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/20/2012|||OK30|ADDITION OF SEVERAL OVENS FOR TERMINAL LIQUID STERILIZATION.
P100010|S021|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/20/2012|||OK30|CHANGE TO A SEMI-AUTOMATED SANDING METHOD AT A COMPONENT SUPPLIER.
P960058|S099|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/22/2012|08/19/2013|||APPR|CHANGE TO THE LI-ION RECHARGEABLE BATTERY PACK USED WITH THEPLATINUM SOUND PROCESSOR (PSP) AND THE S-SERIES SOUND PROCESSOR.
P810031|S046|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2012|01/11/2013|||APPR|APPROVAL FOR A NEW SECONDARY CARTON PACKAGE CONTAINING ONE HEATON OVD (0.55 ML) AND ONE HEATON® ENDOCOAT OVD (0.85 ML). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEATON DUET DUAL PACK AND IS INDICATED FOR:  HEALON:HEATON® OVD IS INTENDED FOR USE AS A SURGICAL AID IN CATARACT EXTRACTION (INTRA- AND EXTRACAPSULAR), IOL IMPLANTATION, CORNEAL TRANSPLANT, GLAUCOMA FILTRATION AND RETINAL ATTACHMENT SURGERY.  HEATON ENDOCOAT:HEATON® ENDOCOAT OVD, MODEL VT585 IS INTENDED FOR USE AS A SURGICAL AID IN PATIENTS UNDERGOING OPHTHALMIC ANTERIOR SEGMENT PROCEDURES INCLUDING:  1) CATARACT SURGERY WITH AN INTRAOCULAR LENS;  2) CATARACT SURGERY WITHOUT AN INTRAOCULAR LENS; AND 3) SECONDARY INTRAOCULAR LENS IMPLANTATION.  HEATON® ENDOCOAT OVD MAINTAINS A DEEP CHAMBER DURING ANTERIOR SEGMENT SURGERY, AIDS IN TISSUE MANIPULATION DURING SURGERY, ENHANCES VISUALIZATION DURING THE SURGICAL PROCEDURE AND PROTECTS THE CORNEAL ENDOTHELIUM AND OTHER OCULAR TISSUE. THE VISCOELASTICITY OF THE SOLUTION MAINTAINS THE NORMAL POSITION OF THE VITREOUS FACE AND PREVENTS FORMATION OF A FLAT CHAMBERDURING SURGERY. IT MAY ALSO BE USED TO COAT INTRAOCULAR LENSES AND INSERTION INSTRUMENTS PRIOR TO INTRAOCULAR LENS IMPLANTATION.
P010030|S038|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|WEARABLE CARDIOVERTER DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/20/2012|||OK30|MODIFICATIONS TO A FIXTURE AND A CHANGE IN THE BACKUP BATTERY CHARGING PROCESS DURING THE THERMAL CYCLING.
P890003|S265|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SYNERGYST II PACING SYSTEM|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/29/2012|05/30/2013|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A DF-4 LEAD COMPATIBLE, CRIMPABLE ALLIGATOR CLIP ONTO THE SURGICAL CABLES, PROCESS IMPROVEMENTS FOR THE SPLICE YOKE OF THE CABLES AND A CHANGE TO THE WIRE GAUGES USED IN THE 2292 CABLE ASSEMBLY.
P030036|S050|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE 4 FRENCH LEAD, 3830|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/19/2012|||OK30|ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS.
P930039|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX NOVUS LEAD, 4076 AND VITATRON CRYSTALLINE LEADS, ICQ09B|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/19/2012|||OK30|ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS.
P820003|S117|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX PACING SYSTEM|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/29/2012|05/30/2013|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A DF-4 LEAD COMPATIBLE, CRIMPABLE ALLIGATOR CLIP ONTO THE SURGICAL CABLES, PROCESS IMPROVEMENTS FOR THE SPLICE YOKE OF THE CABLES AND A CHANGE TO THE WIRE GAUGES USED IN THE 2292 CABLE ASSEMBLY.
P080006|S046|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITTY LV LEAD, 4196, ATTAIN ABILITY PLUS LV LEAD, 4296, ATTAIN ABILITY STRAIGHT LV LEAD, 4296|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/19/2012|||OK30|ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS.
P090013|S078|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX MRI LEAD, 5086MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/19/2012|||OK30|ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS.
P830061|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, 4073, CAPSURE SENSE UNIPOLAR LEAD, CAPSURE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON CRYSTALI|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/19/2012|||OK30|ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS.
P070014|S035|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2012|11/21/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER TO MANUFACTURE LARGER STENT SIZES.
P990004|S023|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE|LMF|SU|135 Review Track For 30-Day Notice||N|10/22/2012|01/09/2013|||APPR|APPROVAL FOR A CHANGE IN THE LOCATION OF THE FERROSAN MEDICAL DEVICES A/S (FEMD) TESTING LABORATORY IN SOEBORG, DENMARK.
P970051|S098|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2012|11/20/2012|||OK30|RE-INSTALLATION OF A LASER WELDER SYSTEM.
P000037|S030|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/23/2012|04/01/2015|||APPR|APPROVAL FOR A LABELING CHANGE TO ALLOW AORTIC VALVE REPLACEMENT PATIENTS TO BE TREATED USING A LOWERED ANTICOAGULATION TARGET.
P850079|S060|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|COPPERVISION METHAFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2012|11/20/2012|||OK30|ELIMINATE SECONDARY REPEAT TESTING.
P990046|S030|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2012|11/20/2012|||OK30|ADDITION OF A DUAL CHAMBER COATER.
P090028|S004|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice||N|10/17/2012|11/13/2012|||OK30|MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
P950022|S085|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|OPTISURE|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/2012|02/21/2014|||APPR|APPROVAL FOR THE OPTISURE HIGH VOLTAGE LEAD FAMILY.
P020014|S039|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/19/2012|12/20/2012|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100023|S057|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2012|11/20/2012|||OK30|CHANGES TO PROXIMAL BALLOON BOND MANUFACTURING SOFTWARE.
P120006|S001|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Real-Time Process||N|10/24/2012|12/11/2012|||APPR|APPROVAL FOR MODIFICATIONS TO THE ENDOVASCULAR SYSTEM, MAINLY THE DELIVERY SYSTEM, TO IMPROVE THE EASE-OF-USE DURING DEPLOYMENT.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM AND IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; 2) NON-ANEURYSMAL PROXIMAL AORTIC NECK:  A) WITH A LENGTH OF AT LEAST 7 MM PROXIMAL TO THE ANEURYSM, B) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM, AND C) WITH AN AORTIC ANGLE OF <= 60 DEGREE IF PROXIMAL NECK IS >= 10 MM AND <= 45 DEGREES IF PROXIMAL NECK IS <= 10 MM. 3) ADEQUATE DISTAL ILIAC LANDING ZONE:  A) WITH A LENGTH OF AT LEAST 10 MM, AND B) WITH AN INNER WALL DIAMETER OF NO LESS THEN 8 MM AND NO GREATER THAN 20 MM.
P110010|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2012|11/20/2012|||OK30|CHANGES TO PROXIMAL BALLOON BOND MANUFACTURING SOFTWARE.
P850079|S061|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY 55, FREQUENCY 55 ASPHERIC, FREQUENCY XCEL TORIC, FREQUENCY  55 TORIC|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2012|11/20/2012|||OK30|USE OF FULLY AUTOMATED MANUFACTURING EQUIPMENT IN THE PRODUCTION OF METHAFILCON A CONTACT LENSES.
P090016|S004|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/25/2012|03/08/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950029|S072|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT PACEMAKERS|NVZ|CV|Real-Time Process||N|10/25/2012|12/11/2012|||APPR|APPROVAL FOR A CHANGE TO THE QUARTZ CRYSTAL.
P030052|S010|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2012|11/13/2012|||APPR|APPROVAL FOR LABELING CHANGES TO THE UROVYSION BLADDER CANCER KIT PACKAGE INSERT, KIT AND VIAL LABELING.
P090026|S001|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM|OYA|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2012|11/19/2012|||APPR|APPROVAL FOR THE ADDITION OF INFORMATION TO THE MANUFACTURING PROCEDURES OF THE INSTRUMENT (SPECIFICALLY, THE INSTRUCTIONS FOR APPLICATION OF THE ADHESIVE TO THE MIXER PULLEY ASSEMBLY AND THE IMPLEMENTATION OF A VERIFICATION TEST TO ENSURE THE MIXER PULLEY ASSEMBLIES PASS THE TORQUE SPECIFICATION.)
P980041|S018|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2012|11/19/2012|||APPR|APPROVAL FOR THE ADDITION OF INFORMATION TO THE MANUFACTURING PROCEDURES OF THE INSTRUMENT (SPECIFICALLY, THE INSTRUCTIONS FOR APPLICATION OF THE ADHESIVE TO THE MIXER PULLEY ASSEMBLY AND THE IMPLEMENTATION OF A VERIFICATION TEST TO ENSURE THE MIXER PULLEY ASSEMBLIES PASS THE TORQUE SPECIFICATION.)
P850048|S028|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2012|11/19/2012|||APPR|APPROVAL FOR THE ADDITION OF INFORMATION TO THE MANUFACTURING PROCEDURES OF THE INSTRUMENT (SPECIFICALLY, THE INSTRUCTIONS FOR APPLICATION OF THE ADHESIVE TO THE MIXER PULLEY ASSEMBLY AND THE IMPLEMENTATION OF A VERIFICATION TEST TO ENSURE THE MIXER PULLEY ASSEMBLIES PASS THE TORQUE SPECIFICATION.)
P970038|S017|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENT ON THE ACCESS IMMUNOASSAY SYSTEM|MTG|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2012|11/19/2012|||APPR|APPROVAL FOR THE ADDITION OF INFORMATION TO THE MANUFACTURING PROCEDURES OF THE INSTRUMENT (SPECIFICALLY, THE INSTRUCTIONS FOR APPLICATION OF THE ADHESIVE TO THE MIXER PULLEY ASSEMBLY AND THE IMPLEMENTATION OF A VERIFICATION TEST TO ENSURE THE MIXER PULLEY ASSEMBLIES PASS THE TORQUE SPECIFICATION.)
P030005|S092|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P)|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/2012|05/23/2013|||APPR|APPROVAL FOR THE INTUA CRT-P.
P110029|S006|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2012|11/19/2012|||OK30|CHANGE TO A QUALITY CONTROL TEST METHOD FOR PURIFIED ANTIBODIES USED IN THE MANUFACTURE OF THE ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVECONFIRMATORY ASSAYS.
P100001|S004|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2012|11/19/2012|||OK30|ADDITION OF A SUPPLIER FOR NEGATIVE HUMAN PLASMA.
P920015|S098|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/26/2012|12/19/2012|||APPR|APPROVAL FOR CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURE OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER.
P030036|S051|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/26/2012|12/19/2012|||APPR|APPROVAL FOR CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURE OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER.
P010020|S027|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS)|MIP|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2012|02/06/2013|||APPR|APPROVAL FOR THE LABELING CHANGE FROM 1.5 TESLA (1.5T) MAGNETICRESONANCE IMAGING (MRI) STRENGTH LEVEL TO 3.0 TESLA (3.0T) FOR THE BUNDLED AMS PRODUCTS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES:  1) AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) ARE INTENDED FOR USE IN THE TREATMENT OF CHRONIC, ORGANIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE); 2) AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) TREATS URINARY INCONTINENCE DUE TOREDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY; AND 3) AMS ACTICON NEOSPHINCTER, ARTIFICIAL BOWEL SPHINCTER (ABS) IS TO TREAT SEVERE FECAL INCONTINENCE IN MALES AND FEMALES EIGHTEEN YEARS AND OLDER WHO HAVE FAILED, OR ARE NOTCANDIDATES FOR, LESS INVASIVE FORMS OF RESTORATIVE THERAPY.
P980018|S017|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/01/2012|04/18/2013|||APPR|APPROVAL FOR THE DAKOLINK. V4.0 SOFTWARE FOR HERCEPTEST¿ KIT.
P050051|S016|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/27/2012|||OK30|CHANGE TO THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL.
P080023|S016|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/27/2012|||OK30|CHANGE TO THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL.
P060035|S015|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/27/2012|||OK30|CHANGE TO THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL.
P060007|S022|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/27/2012|||OK30|CHANGE TO THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL.
P110029|S007|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/CONFIMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/27/2012|||OK30|CHANGE TO THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL.
P040012|S050|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2012|12/19/2012|||APPR|APPROVAL FOR MODIFICATION TO THE RX ACCULINK CAROTID STENT SYSTEMS BONDING OF THE INNER MEMBER, GUIDEWIRE LUMEN AND NOTCHED HYPOTUBE.
P090002|S006|DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2012|11/20/2012|||OK30|CHANGES TO THE SEALING PARAMETERS FOR TWO POUCH SEALERS USED FOR SROM SLEEVES BLISTER PACKS.
P040023|S025|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DURALOC OPTION CERAMIC HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2012|11/20/2012|||OK30|CHANGES TO THE SEALING PARAMETERS FOR TWO POUCH SEALERS USED FOR SROM SLEEVES BLISTER PACKS.
P070026|S010|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CREAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2012|11/20/2012|||OK30|CHANGES TO THE SEALING PARAMETERS FOR TWO POUCH SEALERS USED FOR SROM SLEEVES BLISTER PACKS.
P070026|S011|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/31/2012|02/19/2013|||APPR|APPROVAL FOR THE POST-APPROVAL PROTOCOL.
P920015|S099|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2012|12/19/2012|||APPR|APPROVAL FOR A MECHANICAL DESIGN CHANGE TO THE SPRINT QUATTRO MODEL 6935M AND MODEL 6947M LEAD ANALYZER CABLE INTERFACE ACCESSORY.
P950032|S069|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2012|11/20/2012|||APPR|APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELL STRAIN 200 (HEP 200) INTO THE MANUFACTURE OF THE DEVICE.
P980022|S125|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL UNSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2012|01/29/2013|||APPR|APPROVAL FOR DESIGN CHANGES TO THE DRIVE SUPPORT CAP, CASE BOTTOM BORE AND ADDITIONAL GLUE FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MMT-723, MMT-723K), AS COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL SYSTEM.
P870072|S051|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2012|11/29/2012|||OK30|ADDITION OF AUTOMATED EQUIPMENT FOR THE ANNEALING PROCESS OF THE DEVICE.
P000021|S024|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIDGE|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2012|11/20/2012|||OK30|NEW SUPPLIER OF NYLON/SURLYN CANISTER FILM.
P020009|S095|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2012|11/23/2012|||OK30|ELIMINATION OF SEVERAL REDUNDANT TESTING REQUIREMENTS FROM THE BALLOON COMPONENT MANUFACTURING PROCESS.
P020027|S019|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2012|11/20/2012|||OK30|NEW SUPPLIER OF NYLON/SURLYN CANISTER FILM.
P040016|S100|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2012|11/23/2012|||OK30|ELIMINATION OF SEVERAL REDUNDANT TESTING REQUIREMENTS FROM THE BALLOON COMPONENT MANUFACTURING PROCESS.
P100023|S058|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|IOP (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2012|11/23/2012|||OK30|ELIMINATION OF SEVERAL REDUNDANT TESTING REQUIREMENTS FROM THE BALLOON COMPONENT MANUFACTURING PROCESS.
P000053|S047|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)|EZY|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/06/2012|02/06/2013|||APPR|APPROVAL FOR THE LABELING CHANGE FROM 1.5 TESLA (1.5T) MAGNETICRESONANCE IMAGING (MRI) STRENGTH LEVEL TO 3.0 TESLA (3.0T) FOR THE BUNDLED AMS PRODUCTS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES:  1) AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) ARE INTENDED FOR USE IN THE TREATMENT OF CHRONIC, ORGANIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE); 2) AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) TREATS URINARY INCONTINENCE DUE TOREDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY; AND 3) AMS ACTICON NEOSPHINCTER, ARTIFICIAL BOWEL SPHINCTER (ABS) IS TO TREAT SEVERE FECAL INCONTINENCE IN MALES AND FEMALES EIGHTEEN YEARS AND OLDER WHO HAVE FAILED, OR ARE NOTCANDIDATES FOR, LESS INVASIVE FORMS OF RESTORATIVE THERAPY.
P050019|S011|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/27/2012|||OK30|ADDITION OF ALTERNATE EXTRUSION LINES FOR COMPONENTS.
P090013|S079|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/28/2012|||OK30|REPLACEMENT LASER WELDING EQUIPMENT.
P930039|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/28/2012|||OK30|REPLACEMENT LASER WELDING EQUIPMENT.
P960040|S280|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPT, ENERGEN AND PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/29/2012|||OK30|ALTERNATE SUPPLIER FOR A MODIFIED WELDING COMPONENT.
P010012|S313|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN, PUNCTUA CRTS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/29/2012|||OK30|ALTERNATE SUPPLIER FOR A MODIFIED WELDING COMPONENT.
P040024|S064|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2012|11/29/2012|||OK30|CHANGE TO A NEW VISION SYSTEM FOR THE VERIFICATION OF LOT NUMBER AND EXPIRATION DATE FOR THE ASSEMBLY MACHINE IN FACTORY 1.
P980035|S298|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2012|12/12/2012|||APPR|APPROVAL FOR AN UPDATE TO THE L303 AND L310 INTEGRATED CIRCUIT.
P980016|S388|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR/VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2012|12/12/2012|||APPR|APPROVAL FOR AN UPDATE TO THE L303 AND L310 INTEGRATED CIRCUIT.
P010031|S340|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II CRT-D, CONSULTA DF4-ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D AND PROTECTA XT CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2012|12/12/2012|||APPR|APPROVAL FOR AN UPDATE TO THE L303 AND L310 INTEGRATED CIRCUIT.
P100023|S059|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2012|11/23/2012|||OK30|ADDITION OF A SECOND INJECTION MOLDING LINE FOR MANIFOLD-HYPOTUBE ASSEMBLIES.
P010015|S182|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2012|12/12/2012|||APPR|APPROVAL FOR AN UPDATE TO THE L303 AND L310 INTEGRATED CIRCUIT.
P110037|S003|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP  / COBAS TAQMAN CMV TEST, V2.0|PAB|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2012|01/07/2013|||APPR|APPROVAL FOR TWO NEW VERSIONS OF AMPLILINK SOFTWARE, V3.3.6 AND V3.3.7.
P110010|S033|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2012|11/23/2012|||OK30|ADDITION OF A SECOND INJECTION MOLDING LINE FOR MANIFOLD-HYPOTUBE ASSEMBLIES.
P040016|S101|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2012|11/23/2012|||OK30|REMOVAL OF SEVERAL REDUNDANT INSPECTIONS AT THE FINISHED DEVICE INSPECTION STEP.
P020009|S096|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2012|11/23/2012|||OK30|REMOVAL OF SEVERAL REDUNDANT INSPECTIONS AT THE FINISHED DEVICE INSPECTION STEP.
P060006|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2012|11/23/2012|||OK30|REMOVAL OF SEVERAL REDUNDANT INSPECTIONS AT THE FINISHED DEVICE INSPECTION STEP.
P020025|S036|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2012|08/07/2013|||APPR|APPROVAL FOR BLAZER PRIME XP CATHETER DESIGN MODIFICATIONS, MATERIAL PACKAGING, LABELING CHANGES, AND ADDITION OF ACCESSORIES: INTELLATIP MIFI CABLE, FILTER MODULE, AND REFERENCE CABLE FOR THE INTELLATIP MIFI FAMILY OF CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INTELLATIP MIFI XP ABLATION CATHETER AND IS INDICATED FOR USE WITH THE BSC MAESTRO 3000 CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE BSC HIGH POWER CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.
P080020|S004|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2012|11/30/2012|||OK30|INCREASE IN PRODUCTION CAPACITY.
P980035|S299|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2012|12/04/2012|||OK30|UPDATE TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P010014|S039|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|135 Review Track For 30-Day Notice|Postapproval Study Protocol - OSB|N|11/05/2012|01/04/2013|||APPR|APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
P090013|S080|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2012|12/04/2012|||OK30|UPDATE TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P000025|S066|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, ECA MODULES M7, M8, M9|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2012|12/04/2012|||OK30|ADDITION OF THREE CLEANROOM ECA (ENVIROMENTALLY CONTROLLED AREA) MODULES.
P100023|S060|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2012|11/29/2012|||OK30|MODIFICATION OF THE DISTAL HEAT SHRINK ALIGNMENT SOFTWARE.
P110010|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2012|11/29/2012|||OK30|MODIFICATION OF THE DISTAL HEAT SHRINK ALIGNMENT SOFTWARE.
P860003|S068|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHRESES SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/06/2012|05/01/2013|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM (SOFTWARE VERSION 4.1).
P820003|S118|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOSABLE PATIENT CABLES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2012|12/04/2012|||OK30|MANUFACTURING CHANGES TO THE D01 CONNECTOR AND SOLDER AND FLUX.
P020050|S010|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/2012|11/25/2013|||APPR|APPROVAL FOR A REGISTRATION FEATURE THAT ENABLES PUPIL CENTER SHIFT COMPENSATION AND CYCLOTORSION ADJUSTMENT BASED ON COMPARISON OF DIAGNOSTIC AND TREATMENT IMAGES.
P030008|S009|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/05/2012|11/25/2013|||APPR|APPROVAL FOR A REGISTRATION FEATURE THAT ENABLES PUPIL CENTER SHIFT COMPENSATION AND CYCLOTORSION ADJUSTMENT BASED ON COMPARISON OF DIAGNOSTIC AND TREATMENT IMAGES.
P970003|S154|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2012|02/01/2013|||APPR|APPROVAL FOR AN UPGRADE OF THE PROGRAMMING SOFTWARE TO VERSION 10.0, A NEW PROGRAMMING COMPUTER AND CORRESPONDING ADAPTER CABLE, AND REVISION OF THE HIGH IMPEDANCE THRESHOLD.
P020004|S076|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2012|12/05/2012|||OK30|REMOVAL OF A FINAL DEVICE ACCEPTANCE TEST.
P040043|S049|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2012|12/05/2012|||OK30|REMOVAL OF A FINAL DEVICE ACCEPTANCE TEST.
P050028|S028|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2012|01/02/2013|||APPR|APPROVAL FOR A NEW VERSION OF AMPLILINK SOFTWARE, V3.3.7.
P060030|S030|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/BOBAS TAQMAN HCV TEST|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2012|01/02/2013|||APPR|APPROVAL FOR A NEW VERSION OF AMPLILINK SOFTWARE, V3.3.7.
P110010|S035|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELEUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/05/2012|03/25/2013|||APPR|APPROVAL FOR MODIFYING THE PRECAUTIONS REGARDING LONGITUDINAL STENT DEFORMATION IN THE DIRECTIONS FOR USE.
P890055|S047|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2012|01/16/2013|||APPR|APPROVAL FOR A CHANGE TO THE EPIDURAL FILTER COMPONENT OF THE MEDSTREAM REFILL AND BOLUS KIT, OPERATING ROOM (O.R.) PREP KIT, AND INSTRASPINAL CATHETER KIT.
P010032|S064|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON 16-CHANNEL IPG NEUROSTIMULATION SYSTEM, EON MINI IPG NEUROSTIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2012|12/04/2012|||OK30|CHANGE TO THE ELECTRODE CUTTING PROCESS.
P940034|S019|GEN-PROBE, INC.|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||System, nucleic acid amplification, mycobacterium tuberculosis complex|AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS  DIRECT) TEST|MWA|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2012|12/05/2012|||OK30|CHANGE IN THE AMPLIFICATION POSITIVE CONTROL USED FOR QUALITY CONTROL TESTING.
P080011|S019|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2012|12/05/2012|||OK30|REVALIDATION OF MANUFACTURING EQUIPMENT.
P040044|S044|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/06/2012|01/09/2013|||APPR|APPROVAL FOR MINOR PACKAGING MODIFICATIONS TO THE PACKAGING TRAY.
P950005|S041|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S)|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/2012|06/06/2013|||APPR|APPROVAL FOR MODIFIED CATHETER DESIGNS TO THE 7FR CELSIUS AND 7FR EZ STEER DS CATHETERS TO CREATE THE 7.5FR 8 MM CELSIUS FLTR CATHETERS. THE CHANGES BEING APPROVED ARE THE INCREASED DISTAL PROFILE, LARGER CURVE PROFILE, INCREASED RANGE OF DEFLECTION, AND INCREASED DEFLECTABLE TIP DIAMETER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S) AND UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX-S) AND ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 (WITH SOFTWARE VERSION 001/033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 YEARS OF AGE OR OLDER.
P010068|S031|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S)|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/2012|06/06/2013|||APPR|APPROVAL FOR MODIFIED CATHETER DESIGNS TO THE 7FR CELSIUS AND 7FR EZ STEER DS CATHETERS TO CREATE THE 7.5FR 8 MM CELSIUS FLTR CATHETERS. THE CHANGES BEING APPROVED ARE THE INCREASED DISTAL PROFILE, LARGER CURVE PROFILE, INCREASED RANGE OF DEFLECTION, AND INCREASED DEFLECTABLE TIP DIAMETER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S) AND UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX-S) AND ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 (WITH SOFTWARE VERSION 001/033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 YEARS OF AGE OR OLDER.
P960042|S043|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH|MFA|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/07/2012|06/14/2013|||APPR|APPROVAL FOR A MATERIAL CHANGE TO THE INNER LINER OF THE DEVICES.
P980016|S389|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2012|02/05/2013|||APPR|APPROVAL FOR CLARIFICATIONS TO THE INDICATIONS FOR USE STATEMENTS RELATED TO THE OPTIVOL FEATURE AND OTHER MODIFICATIONS TO THE DEVICE LABELING. THE DEVICES ARE INDICATED AS FOLLOWS:  DUAL CHAMBER ICDSTHE <DEVICE NAME> DR SYSTEM IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.  IN ADDITION, THE DEVICE IS INDICATED FOR USE IN THE ABOVE PATIENTS WITH ATRIALTACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.  NOTES:1) THE USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS.2) THE EFFECTIVENESS OF HIGH-FREQUENCY BURST PACING (ATRIAL 50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.8%, IN THE VT/AT PATIENT POPULATION STUDIED.  3) THE EFFECTIVENESS OF HIGH-FREQUENCY BURST PACING (ATRIAL 50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 11.7%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO 18.2% IN THE AF-ONLY PATIENT POPULATION STUDIED.SINGLE CHAMBER ICDS:  THE <DEVICE NAME> VR SYSTEM IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
P110039|S001|InSightec|5 NAHUM HETH STREET||TIRAT-CARMEL||39120||Ablation system, high intensity focused ultrasound (hifu), mr-guided|INSIGHTEC EXABLATE SYSTEM|NRZ|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/06/2012|03/15/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110039|S002|InSightec|5 NAHUM HETH STREET||TIRAT-CARMEL||39120||Ablation system, high intensity focused ultrasound (hifu), mr-guided|INSIGHTEC EXABLATE SYSTEM|NRZ|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/06/2012|03/15/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040002|S040|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/08/2012|12/28/2012|||APPR|APPROVAL FOR THE ADDITION OF BIFURCATED STENT GRAFT MODELS FOR THE APPROVED AFX ENDOVASCULAR AAA SYSTEM PRODUCT FAMILY.  THE NEW MODELS CONTAIN SHORTER AND LONGER BIFURCATED BODIES THAT WILL HAVE THE SAME DIAMETER AS THOSE CURRENTLY APPROVED; AND TO ADD 20MM DIAMETER LIMBS USING THE SAME STENT CAGE.
P950018|S016|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON OCULAR ENDOTAMPONADE|LWL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/08/2012|07/09/2013|||APPR|APPROVAL FOR CHANGES TO THE ADHESIVE RESINS (LIMONENE-BASED RESIN TR7125 HAS REPLACED THE CURRENT LIMONENE-BASED RESIN TR1135, AND ETHYLENE VINYL ACETATE RESIN UL8705 HAS REPLACED THE CURRENT EVA RESIN 205W) USED FOR THE TYVEK LID AND VALIDATION OF AN AIR-OVER-STEAM (AOS) STERILIZATION CYCLE TO ALIGN PRACTICES AMONG PRODUCTS WITHIN THE MANUFACTURING FACILITY.
P050010|S013|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-L|MJO|OR|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/08/2012|07/31/2014|||APPR|APPROVAL FOR MODIFIED LABELING TO REFLECT FINDINGS OF THE POST-APPROVAL STUDY (PAS).
P010012|S314|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD, LIVIAN, COGNIS, ENERGEN, PUNCTUA AND INCEPTA CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEFIBRILLATOR SYSTEMS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P030005|S093|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P050046|S018|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Permanent defibrillator electrodes|ACUITY STEERABLE HEART FAILURE LEAD FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P830026|S081|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P830060|S074|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P840068|S052|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA / VISTA FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P890061|S022|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK ICD FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P910073|S112|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK AND RELIANCE LEAD FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P990038|S017|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS ASSAY|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/30/2012|||APPR|APPROVAL FOR A CHANGE TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.
P980022|S126|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR GLUCOSE SENSOR|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|03/20/2013|||APPR|APPROVAL FOR THE REMOVAL OF THE IN-PROCESS REFRIGERATION STORAGE REQUIREMENT THROUGHOUT THE FABRICATION AND ASSEMBLY OF THE SENSORS.
P080007|S015|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|E-LUMINEXX VASCULAR STENT|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|04/12/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS BELGIUM PETIT RECHAIN, S.A., IN VERVIERS, BELGIUM.
P070014|S036|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|04/12/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS BELGIUM PETIT RECHAIN, S.A., IN VERVIERS, BELGIUM.
P910077|S129|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND VENTAK MINI ICD FANILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P930035|S024|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 ICD FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P940031|S074|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P950001|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE LEAD FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P990041|S016|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS ASSAY|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/30/2012|||APPR|APPROVAL FOR A CHANGE TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.
P960004|S058|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P960006|S037|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD FAMILIES|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P990042|S013|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS ASSAY|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/30/2012|||APPR|APPROVAL FOR A CHANGE TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.
P960040|S281|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, AND TELIGEN, PUNCTUA, ENERGEN, AND INCEPTA ICD FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2012|12/05/2012|||OK30|REPLACE THE TRACEABILITY AND TRACKING SYSTEM.
P990043|S017|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS ASSAY|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/30/2012|||APPR|APPROVAL FOR A CHANGE TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.
P990044|S014|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS ASSAY|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/30/2012|||APPR|APPROVAL FOR A CHANGE TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.
P990045|S014|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS ASSAY|LOM|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/30/2012|||APPR|APPROVAL FOR A CHANGE TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.
P850079|S062|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|12/04/2012|||OK30|INCREASE THE CAPACITY OF DRY LENS MANUFACTURING.
P860057|S095|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL VALVES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/26/2012|||OK30|CHANGES TO CLEAN ROOMS #1, 2 AND 3 IN THE CHANGI, SINGAPORE FACILITY
P100023|S061|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/23/2012|||OK30|UPDATES TO THE VISUAL STANDARD INSPECTION CRITERIA FOR GOUGES.
P110010|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|11/23/2012|||OK30|UPDATES TO THE VISUAL STANDARD INSPECTION CRITERIA FOR GOUGES.
P980022|S127|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|IPRO2 CGM RECORDER|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|02/20/2013|||APPR|APPROVAL FOR MANUFACTURING CHANGES TO THE IPRO2 RECORDER COMPONENT OF THE IPRO2 CONTINUOUS GLUCOSE MONITORING SYSTEM THAT AFFECT THE SERIAL AND MODEL NUMBER ASSIGNMENT TOOL AND THE ACCURACY TESTER DEVICE LEVEL TESTER SOFTWARE.
P070015|S104|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|12/05/2012|||OK30|ADDITION OF A SECOND STERILIZATION CHAMBER IN IRELAND.
P110019|S037|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|12/05/2012|||OK30|ADDITION OF A SECOND STERILIZATION CHAMBER IN IRELAND.
P020047|S053|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8, MULTI-LINK 8 SV AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2012|12/05/2012|||OK30|ADDITION OF A SECOND STERILIZATION CHAMBER IN IRELAND.
P100013|S007|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXCOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/13/2012|||OK30|ALTERNATE STERILIZATION MINIMUM DOSE.
P840064|S052|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICES (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/12/2012|||OK30|ADDITION OF AN ALTERNATE SYRINGE SUPPLIER.
P970004|S146|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY INS INTERSTIM FAMILY|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|03/27/2013|||APPR|APPROVAL FOR AN UPDATE TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P080025|S042|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL INS INTERSTIM FAMILY|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|03/27/2013|||APPR|APPROVAL FOR AN UPDATE TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P020004|S077|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/13/2012|||OK30|REPLICATION OF A MANUFACTURING LINE IN PHOENIX, ARIZONA.
P110042|S001|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE HEADER PREPARATION AND ATTACHMENT PROCESS.
P980007|S027|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA AND AXSYM FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/11/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED BRIJ L23 SOLUTION.
P910007|S036|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA AND AXSYM TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/11/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED BRIJ L23 SOLUTION.
P820060|S031|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AXSYM AFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/11/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED BRIJ L23 SOLUTION.
P060007|S023|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P110029|S008|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/HBSAG QUALITATIVE CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P050051|S017|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P080023|S017|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P060035|S016|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P050042|S019|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P050049|S011|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM HBSAG/HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P060003|S012|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P060012|S010|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE 2.0|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P060009|S007|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT: 09VB BLDG: AP5-2|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|AXSYM CORE-M 2.0|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P910073|S113|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE DF4 LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/12/2012|||OK30|UPGRADE THE FINAL TEST STATION (FTS) EQUIPMENT.
P020018|S047|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/12/2012|||OK30|LOWERING OF THE ACCEPTANCE TESTING CRITERION FOR AN IN-PROCESS TESTING.
P970027|S018|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|3500|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|AXSYM ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/05/2012|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED DETERGENT.
P050050|S005|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)|NTG|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2012|01/24/2013|||APPR|APPROVAL FOR A REVISED PACKAGE INSERT WHICH INCLUDES ADDITIONAL POTENTIAL ADVERSE EVENTS REPORTED IN RECENT STAR ANKLE PUBLICATIONS.
P960058|S100|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/2012|03/12/2013|||APPR|APPROVAL FOR THE HIRES OPTIMA SOUND PROCESSING STRATEGY.  HIRES OPTIMA IS A MODIFICATION OF THE HIRES FIDELITY 120 STRATEGY, AND IS INTENDED TO OPTIMIZE POWER EFFICIENCY. THIS NEW STRATEGY IMPROVES BATTERY LIFE WITHOUT COMPROMISING THE LISTENING BENEFITS OF THE HIRESOLUTION BIONIC EAR SYSTEM.
P060008|S099|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/11/2012|||OK30|REMOVAL OF A REDUNDANT STEP IN THE CATHETER ASSEMBLY.
P860057|S096|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|VARIOUS FAMILIES OF PERIMOUNT, RSR, THEON, RSR PERICARDIAL AORTIC BIOPROSTHESES & VARIOUS FAMILIES OF MAGNA, THEON, PLUS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/10/2012|||OK30|USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.
P830055|S129|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LSC TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|11/29/2013|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT STERIS ISOMEDIX, CHESTER, NEW YORK, AND SYNERGY HEALTH SWITZERLAND, DÄNIKEN, SWITZERLAND.  BOTH FACILITIES WILL PERFORM STERILIZATION OPERATIONS FOR THE LCS TOTAL KNEE SYSTEM.
P080014|S014|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/14/2012|||OK30|ADD AN ALTERNATIVE MANUFACTURING PROCESS METHOD TO THE CURRENT METHOD FOR THE DEVICE.
N18033|S067|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/11/2012|||OK30|MODIFICATIONS TO AN IN-PROCESS TEST METHOD.
P950020|S057|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CORONARY FLEXTOME CUTTING BALLOON||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/11/2012|||OK30|REMOVAL OF A REDUNDANT STEP IN THE CATHETER ASSEMBLY.
P020009|S097|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/11/2012|||OK30|REMOVAL OF A REDUNDANT STEP IN THE CATHETER ASSEMBLY.
P040016|S102|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/11/2012|||OK30|REMOVAL OF A REDUNDANT STEP IN THE CATHETER ASSEMBLY.
P870056|S053|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/10/2012|||OK30|USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.
P870077|S048|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/10/2012|||OK30|USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.
P000007|S035|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/10/2012|||OK30|USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.
P900061|S117|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL ICD, JEWEL PLUS ICD, MICRO JEWEL ICD, MICRO JEWEL II ICD, GEM ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/12/2012|||OK30|TRANSFER OF A SUPPLIER MANUFACTURING OPERATION TO A NEW LOCATION.
P010041|S037|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/10/2012|||OK30|USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.
P040044|S045|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2012|07/22/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN SANTA CLARA, CALIFORNIA.
P100041|S016|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/10/2012|||OK30|USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.
P980016|S390|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II VR ICD,MARQUIS VR ICD,GEM III VR ICD,MAXIMO VR ICD,GEM DR ICD,GEM II DR ICD,MARQUIS DR ICD,GEM III DR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/12/2012|||OK30|TRANSFER OF A SUPPLIER MANUFACTURING OPERATION TO A NEW LOCATION.
P110021|S001|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2012|12/10/2012|||OK30|USE OF A QUALITY MANAGEMENT SYSTEM SOFTWARE.
P000037|S031|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice||N|11/14/2012|12/01/2012|||OK30|MOVE THE MACHINING PROCESS FOR SPECIFIED SIZES OF VALVE HOUSING SUBSTRATES IN-HOUSE.
P050039|S014|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2012|12/05/2012|||OK30|ADDITION OF A PACKAGE SEALER.
P010012|S315|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY SPIRAL AND EASYTRAK 3 IS-1 LEADS|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2012|12/20/2012|||APPR|APPROVAL FOR AN ALTERNATE PRIMER MATERIAL.
P050046|S019|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE LEAD FAMILY|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2012|12/20/2012|||APPR|APPROVAL FOR AN ALTERNATE PRIMER MATERIAL.
P980031|S011|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS CORNEAL IMPLANTS|LQE|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2012|12/19/2012|||OK30|OUTSOURCING OF THE INTACS SEGMENT THICKNESS AND PACKAGING COMPONENT INSPECTION ACTIVITIES.
P910023|S309|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2012|06/06/2013|||APPR|APPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P030054|S238|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2012|06/06/2013|||APPR|PPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P880086|S229|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2012|06/06/2013|||APPR|PPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P030035|S107|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2012|06/06/2013|||APPR|PPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P860004|S178|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2012|12/06/2012|||OK30|MANUFACTURING CHANGE TO AUTOMATE READING OF IDENTIFIERS FOR THE SYNCHROMED II INFUSION PUMP, MODEL 8637.
P980022|S128|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MEDTRONIC MINIMED CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2012|02/11/2013|||APPR|APPROVAL FOR A CHANGE TO THE PACKAGING OF A LOW DROPOUT (LDO)REGULATOR INTEGRATED CIRCUIT TO HALOGEN FREE AND A CHANGE OF THE SOLDER PLATING TO PURE TIN SOLDER PLATING FOR THE MINILINK REAL-TIME TRANSMITTER (MMT-7703), CGMS IPRO RECORDER (MMT- 7709), AND IPRO2 RECORDER (MMT-7741) COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, CGMS IPRO, AND IPRO2 PROFESSIONAL GLUCOSE MONITORING SYSTEMS.
P980023|S049|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2012|02/13/2013|||APPR|APPROVAL FOR THE ADDITION OF A NEW MODEL TO THE LINOX SMART ICD LEAD  FAMILY.  THIS NEW MODEL WILL BE MARKETED UNDER THE TRADE NAME LINOX SMART S DX ICD LEAD AND INDICATED FOR USE IN THE RIGHT VENTRICLE OF PATIENTS FOR WHOM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AREINDICATED; IT CAN ONLY BE USED WITH THE LUMAX VR-T DX ICD AS A SYSTEM. THE LEAD INCORPORATES TWO ATRIAL SENSING RINGS THAT REPLACE THE SVC COIL; IN ADDITION, AN IS-1 CONNECTOR WAS ADDED FOR THE ATRIAL SENSING RINGS AND THE DF-1 CONNECTOR FOR THE SVC COIL WAS REMOVED.
P980022|S129|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP, PARADIGM REAL TIME REVEL INSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/15/2012|02/11/2013|||APPR|APPROVAL FOR SUBSTITUTING THE CURRENT PVC INSULATION MATERIAL OF THE VIBRATOR MOTOR WIRING OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODEL NUMBERS: MMT-522, MMT-522K, MMT-523, MMT-523K, MMT-722, MMT-722K, MMT-723, AND MMT-723K) WITH HALOGEN-FREE MATERIAL.
P980035|S300|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/12/2012|||OK30|UPDATES TO THE FINAL TEST APPLICATION.
P010015|S183|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/12/2012|||OK30|UPDATES TO THE FINAL TEST APPLICATION.
P880006|S084|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2012|06/06/2013|||APPR|PPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P970013|S054|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2012|06/06/2013|||APPR|PPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P090028|S005|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|11/26/2012|||OK30|ADDITION OF A SUPPLIER FOR NEGATIVE HUMAN PLASMA.
P980007|S028|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/07/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P910007|S037|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/07/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P950020|S058|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CORONARY FLEXTOME CUTTING BALLON||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/13/2012|||OK30|ADDITION OF ALTERNATE MANUFACTURING EQUIPMENT TO TEST FOR BALLOON LEAKS IN THE DEVICE.
P050042|S020|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/10/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P050051|S018|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/10/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P110010|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|11/23/2012|||OK30|SOFTWARE UPGRADE TO THE VISICON INSPECTION SYSTEM.
P100023|S062|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|11/23/2012|||OK30|SOFTWARE UPGRADE TO THE VISICON INSPECTION SYSTEM.
P900056|S117|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/28/2012|||OK30|TRANSFER OF THE ENDOTOXIN (LAL) TESTING TO A NEW LOCATION.
P100024|S004|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2012|04/19/2013|||APPR|APPROVAL FOR THE DAKOLINK V4.0 SOFTWARE FOR HER2 CISH PHARMDX¿ KIT.
P980016|S391|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DF4 CRT-D, MAXIMO II DF4 ICD, MAXIMO II ICD, PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/11/2012|||OK30|ADD HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE.
P010031|S341|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 CR||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/11/2012|||OK30|ADD HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE.
P080023|S018|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/10/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P060035|S017|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/10/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P060007|S024|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/10/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P110029|S009|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/10/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P110012|S002|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT|OWE|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/26/2012|||OK30|QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
P980024|S009|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/26/2012|||OK30|QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
P080032|S011|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|12/11/2012|||OK30|IMPLEMENTATION OF CHANGE RELATED TO THE STERILIZATION OF THE CATHETER WHICH IS USED WITH THE DEVICE.
P050028|S029|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP / COBAS TAQMAN HBV TEST, V2.0|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2012|02/11/2013|||APPR|APPROVAL FOR A NEW VERSION OF COBAS P 630 SOFTWARE, V2.2.7.
P060030|S031|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP / COBAS TAQMAN HCV TEST|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2012|02/11/2013|||APPR|APPROVAL FOR A NEW VERSION OF COBAS P 630 SOFTWARE, V2.2.7.
P110037|S004|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP / COBAS TAQMAN CMV TEST|PAB|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/16/2012|02/11/2013|||APPR|APPROVAL FOR A NEW VERSION OF COBAS P 630 SOFTWARE, V2.2.7.
P060008|S100|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE MONORAIL AND AND OVER-THE-WIRE CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/11/2012|||OK30|REMOVAL OF TWO IN-PROCESS INSPECTIONS.
P100023|S063|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/11/2012|||OK30|REMOVAL OF TWO IN-PROCESS INSPECTIONS.
P020009|S098|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/11/2012|||OK30|REMOVAL OF TWO IN-PROCESS INSPECTIONS.
P040016|S103|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/11/2012|||OK30|REMOVAL OF TWO IN-PROCESS INSPECTIONS.
P110010|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/11/2012|||OK30|REMOVAL OF TWO IN-PROCESS INSPECTIONS.
P020009|S099|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/13/2012|||OK30|CHANGE TO THE ANNEALING TEMPERATURES FOR DELIVERY CATHETERS.
P040016|S104|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/13/2012|||OK30|CHANGE TO THE ANNEALING TEMPERATURES FOR DELIVERY CATHETERS.
P060006|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/13/2012|||OK30|CHANGE TO THE ANNEALING TEMPERATURES FOR DELIVERY CATHETERS.
P100023|S064|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/13/2012|||OK30|CHANGE TO THE ANNEALING TEMPERATURES FOR DELIVERY CATHETERS.
P110010|S039|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2012|12/13/2012|||OK30|CHANGE TO THE ANNEALING TEMPERATURES FOR DELIVERY CATHETERS.
P970051|S100|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|03/13/2013|||APPR|APPROVAL FOR THE INTRODUCTION OF A CRIMP PULL TESTER.
P970051|S101|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2012|03/13/2013|||APPR|APPROVAL FOR THE INTRODUCTION OF A VACUUM PICKUP TOOL.
P050042|S021|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/14/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P930031|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/18/2012|||OK30|ADDITION OF ALTERNATE SUPPLIER FOR POLYMER FILMS USED IN PACKAGING.
P050051|S019|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/14/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P050019|S012|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P080023|S019|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/14/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P940019|S033|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (ILIAC) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/18/2012|||OK30|ADDITION OF ALTERNATE SUPPLIER FOR POLYMER FILMS USED IN PACKAGING.
P060035|S018|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/14/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P060007|S025|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/14/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P110029|S010|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/14/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P980033|S027|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/18/2012|||OK30|ADDITION OF ALTERNATE SUPPLIER FOR POLYMER FILMS USED IN PACKAGING.
P110035|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P090003|S019|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P060006|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P020009|S100|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P990064|S044|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/19/2012|||OK30|MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.
P950020|S059|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||FLEXTOME CUTTING BALLOON DILATATION DEVICE||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P980043|S036|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHETIC HEART VALVE|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/19/2012|||OK30|MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.
P100023|S065|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P110010|S040|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P790007|S033|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/19/2012|||OK30|MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.
P870078|S017|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/19/2012|||OK30|MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.
P900056|S118|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P030025|S099|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P040045|S034|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/27/2012|||OK30|IMPLEMENTATION OF AN ALTERNATE NEW TEST METHOD FOR LENS MONOMER LEACHABLE.
P980007|S029|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/07/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P910007|S038|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/07/2012|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P960058|S101|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|09/17/2013|||APPR|IMPROVEMENT TO THE HIRESOLUTION BIONIC EAR SYSTEM¿S HYBRID INSPECTION PROCESS.
P970031|S037|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/19/2012|||OK30|MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.
P060008|S101|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P960040|S282|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|ADD A NEW OFF-THE-SHELF LASER WELDER FOR USE IN THE BATTERY MANUFACTURING.
P040016|S105|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P940019|S034|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ILIAC ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P930031|S039|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P980033|S028|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|USE OF AN ELECTRONIC RECORDS SYSTEM.
P010012|S316|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, ENERGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/11/2012|||OK30|ADD A NEW OFF-THE-SHELF LASER WELDER FOR USE IN THE BATTERY MANUFACTURING.
P050026|S001|VALEANT PHARMACEUTICALS LUXEMBOURG S.A.R.L.|208 VAL DES BONS MALADES||GRAND DUCHY OF LUXEMBOURG||L-212|2121|SYSTEM, LASER, PHOTODYNAMIC THERAPY|QCELLUS LASER|MVF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/19/2012|09/26/2013|||APPR|APPROVAL FOR: 1) CHANGE IN THE NAME OF THE DEVICE FROM ACTIVIS LASER TO QCELLUS LASER; 2) CHANGE IN THE LASER DESIGN TO COMBINE THE LASER MODULE AND SLIT LAMP ADAPTER INTO A SINGLE UNIT TO BE MOUNTED DIRECTLY ON THE TONOMETER POST OF A HAAG-STREIT 900 BM/BQ SLIT LAMP OR EQUIVALENT; AND 3) CHANGE MANUFACTURING SITE FOR THE QCELLUS LASER TO QLT, INC., VANCOUVER, BC, CANADA.
P820021|S035|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/18/2012|||OK30|CHANGES IN TWO TEST METHODS.
P000029|S073|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2012|12/19/2012|||OK30|CHANGE THE METHOD OF VERIFICATION OF PRINTED INFORMATION ON THE PRODUCT LABELS.
P100014|S008|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2012|12/19/2012|||OK30|CHANGE THE METHOD OF VERIFICATION OF PRINTED INFORMATION ON THE PRODUCT LABELS.
P100012|S001|NUVASIVE, INC.|7475 LUSK BLVD||SAN DIEGO|CA|92121||PROSTHESIS, INTERVERTEBRAL DISC|NUVASIVE'S PCM CERVICAL DISC|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/19/2012|02/06/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980003|S037|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOL ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|12/17/2012|||OK30|UPDATES TO THE IN-PROCESS INSPECTION.
P050023|S057|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILY OF ICD AND CRT-D|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/19/2012|02/12/2013|||APPR|APPROVAL FOR THREE SEPARATE MODIFICATIONS TO THE BATTERIES USED IN THE PULSE GENERATORS.
P950037|S113|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA/ENTOVIS/ECURO/EFFECTA/ESTELLA PULSE GENERATORS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/19/2012|02/12/2013|||APPR|APPROVAL FOR THREE SEPARATE MODIFICATIONS TO THE BATTERIES USED IN THE PULSE GENERATORS.
P070008|S035|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|EVIA HF,EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/19/2012|02/12/2013|||APPR|APPROVAL FOR THREE SEPARATE MODIFICATIONS TO THE BATTERIES USED IN THE PULSE GENERATORS.
P970003|S155|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY PULSE/PULSE DUO GENERATOR|MUZ|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2012|02/25/2013|||APPR|APPROVAL FOR A MODIFICATION TO THE ELECTRICAL TEST SYSTEM (ETS) SOFTWARE USED IN PRODUCTION.
P860057|S097|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMAFIX|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/11/2012|||OK30|USE OF JAR TORQUE MACHINES.
P910023|S310|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/17/2012|||OK30|MODIFICATIONS TO AUTOMATED MANUFACTURING TESTS.
P100041|S017|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM RETROFLEX BALLOON CATHETER EDWARDS|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/11/2012|||OK30|USE OF JAR TORQUE MACHINES.
P020004|S078|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/21/2012|||OK30|CHANGE TO THE PARAMETERS FOR BONDING THE OLIVE TO THE CATHETER SHAFT.
P110021|S002|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM,RETROFLEX BALLOON CATHETER|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/11/2012|||OK30|USE OF JAR TORQUE MACHINES.
P910073|S114|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE IS-1/IS-4 ACTIVE AND PASSIVE FIXATION DEFIBRILATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/18/2012|||OK30|NEW LASER WELDING EQUIPMENT USED FOR THE MANUFACTURING OF DEFIBRILLATION LEADS.
P000007|S036|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/11/2012|||OK30|USE OF JAR TORQUE MACHINES.
P010041|S038|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/11/2012|||OK30|USE OF JAR TORQUE MACHINES.
P870056|S054|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/11/2012|||OK30|USE OF JAR TORQUE MACHINES.
P870077|S049|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS,CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/11/2012|||OK30|USE OF JAR TORQUE MACHINES.
P030054|S239|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/17/2012|||OK30|MODIFICATIONS TO AUTOMATED MANUFACTURING TESTS.
P010030|S039|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2012|12/20/2012|||APPR|APPROVAL FOR:1) DESIGN MODIFICATIONS TO THE MONITOR ENCLOSURE; 2) ADDITION OF EP11HT GRAY EPOXY TO THE HIGH VOLTAGE CAPACITOR SOLDER JOINTS; AND3) ADDITION OF LOCTITE 3536 EPOXY UNDERFILL TO THE BALL GRID ARRAY COMPONENTS OF THE PRINTED CIRCUIT ASSEMBLIES
P980016|S392|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INTRINSIC ICD, MARQUIS DR ICD, & VR ICD, MAXIMO DR ICD, MAXIMO II ICD & VR ICD, PROTECTA ICD & XT ICD, SECURA ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P890003|S266|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P900061|S118|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P920015|S100|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR /EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P930029|S037|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONDUCTR, RF CONTACTR, RF ENHANCER II, RF MARINR, RF MARINR UNIPOLAR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P930039|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SURFIX LEAD, TORQUE CLIP DEVICE -ACCESSORY FOR 5076 LEAD, VITATRON CRYSTALLINE L|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P950024|S046|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACKING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P980035|S301|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P980050|S079|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P990001|S109|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P010015|S184|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P010031|S342|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICD, CONCERTO II CRT-D & DF4 ICD, CONSULTA ICD, INSYNC II MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P030036|S052|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT, SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P060039|S039|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P080006|S047|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P090013|S081|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P820003|S119|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADAPTOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P830061|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS + LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P850089|S091|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2012|12/20/2012|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P110010|S041|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2012|12/19/2012|||OK30|SOFTWARE MODIFICATIONS TO THE BALLOON MANUFACTURING EQUIPMENT.
P010014|S040|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2012|12/21/2012|||OK30|MANUFACTURING CHANGES RELATED TO THE KNEE SYSTEM.
P860004|S179|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/2012|12/20/2012|||APPR|APPROVAL FOR UPDATED WARNING AND PRECAUTIONS AND PROCEDURES RELATED TO SUBCUTANEOUS OVERDOSE.
P990034|S029|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/2012|12/20/2012|||APPR|APPROVAL FOR UPDATED WARNING AND PRECAUTIONS AND PROCEDURES RELATED TO SUBCUTANEOUS OVERDOSE.
P110008|S001|PARADIGM SPINE, LLC|505 PARK AVENUE, 14TH  FLOOR||NEW YORK|NY|10022||Prosthesis, spinous process spacer/plate|COFLEX® INTERLAMINAR TECHNOLOGY|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/26/2012|04/23/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
N18286|S024|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM (ABSORABLE GELATIN) POWDER, USP|LMF|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/26/2012|01/07/2013|||APPR|APPROVAL FOR A MINOR CHANGE IN LABELING INSTRUCTIONS TO INCLUDE MIXING GELFOAM POWDER WITH DILUENTS OF SALINE FOR INJECTION OR THROMBIN.  NO OTHER CHANGE INCLUDED IN THIS APPROVAL ORDER.  THE DEVICE ALONG WITH THE MODIFIED LABELING WILL BE MARKETED UNDER THE TRADE NAME GELFOAM ABSORBABLE GELATIN POWDER:  IS INTENDED AS A HEMOSTATIC DEVICE FOR SURGICAL PROCEDURES WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS EITHER INEFFECTIVE OR IMPRACTICAL.  ALTHOUGH NOT NECESSARY, GELFOAM STERILE POWDER CAN BE USED EITHER WITH OR WITHOUT THROMBIN TO OBTAIN HEMOSTASIS.
P930031|S040|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT RP ENDOPROSTHESIS AND WALLSTENT ENDOPROTHESIS (TIPS)|MIR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|06/18/2013|||APPR|APPROVAL FOR USE OF AN ALTERNATE PTFE MATERIAL.
P090003|S020|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/21/2012|||OK30|CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
P060006|S039|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice||N|11/27/2012|12/21/2012|||OK30|CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
P020009|S101|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/21/2012|||OK30|CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
P980033|S029|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT RP ENDOPROSTHESIS AND WALLSTENT ENDOPROSTHESIS (VENOUS)|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|06/18/2013|||APPR|APPROVAL FOR USE OF AN ALTERNATE PTFE MATERIAL.
P100023|S066|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/21/2012|||OK30|CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
P110010|S042|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/21/2012|||OK30|CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
P030025|S100|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/21/2012|||OK30|CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
P100047|S001|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/21/2012|||OK30|CHANGE TO SUPPLIER OF AN ELECTRONIC COMPONENT.
P940019|S035|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT RP ENDOPROSTHESIS (ILIAC)|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|06/18/2013|||APPR|APPROVAL FOR USE OF AN ALTERNATE PTFE MATERIAL.
P910001|S062|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/26/2012|||OK30|ADDITION OF A NEW COMPUTER NUMERIC CONTROL (CNC) MACHINING TOOL.
P960042|S045|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATHS SLS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/26/2012|||OK30|ADDITION OF A NEW COMPUTER NUMERIC CONTROL (CNC) MACHINING TOOL.
P100047|S002|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/26/2012|||OK30|CHANGE TO SUPPLIER OF AN ELECTRONIC COMPONENT.
P100047|S003|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/27/2012|||OK30|PROCESS CHANGE IN THE MANUFACTURING AND ASSEMBLY OF THE DRIVELINE CONNECTOR.
P020004|S079|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/27/2012|||OK30|REVISIONS TO THE ROUTINE QUALITY CONTROL TESTING CONDUCTED AT A QUALIFIED SUPPLIER OF POLYTETRAFLUOR-ETHYLENE (PTFE) AND FLUORINATED ETHYLENE PROPYLENE (FEP) LAMINATED MEMBRANES.
P040043|S050|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/27/2012|||OK30|REVISIONS TO THE ROUTINE QUALITY CONTROL TESTING CONDUCTED AT A QUALIFIED SUPPLIER OF POLYTETRAFLUOR-ETHYLENE (PTFE) AND FLUORINATED ETHYLENE PROPYLENE (FEP) LAMINATED MEMBRANES.
P060008|S102|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/21/2012|||OK30|CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
P040016|S106|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2012|12/21/2012|||OK30|CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE.
P860057|S098|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT FAMILY OF PERICARDIAL BIOPROSTHESES|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2012|02/28/2013|||APPR|APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.
P100041|S018|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDW|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2012|02/28/2013|||APPR|APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.
P110021|S003|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWAR|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2012|02/28/2013|||APPR|APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.
P030017|S146|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2012|12/28/2012|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A PACKAGING COMPONENT.
P080027|S007|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2012|12/17/2012|||APPR|APPROVAL FOR A NEW QUALITY CONTROL TEST METHOD FOR EVALUATION OF A RAW MATERIAL USED IN THE MANUFACTURING OF THE DEVICE.
P090002|S007|DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/28/2012|12/21/2012|||APPR|APPROVAL FOR CHANGES TO THE PRODUCT LABELING/ INFORMATION FOR USE FOR THE DEVICE.
P000007|S037|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2012|02/28/2013|||APPR|APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.
P010041|S039|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V AORTIC PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2012|02/28/2013|||APPR|APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.
P870056|S055|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2012|02/28/2013|||APPR|APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.
P870077|S050|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE|DYE|CV|135 Review Track For 30-Day Notice||N|11/28/2012|02/28/2013|||APPR|APPROVAL TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE.
P080006|S048|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice||N|11/29/2012|12/26/2012|||OK30|ADDITIONAL SUPPLIER FOR EXTRUDED TUBING.
P020004|S080|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|12/21/2012|||OK30|USE AN ALTERNATE RAW MATERIAL IN THE GRAFT TUBE COMPONENTS OF THE EXCLUDER DEVICE.
P100047|S004|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|01/04/2013|||OK30|USE OF AN ADDITIONAL ETHYLENE OXIDE STERILIZATION CHAMBER AT STERIGENICS, LOCATED IN SALT LAKE CITY, UTAH.
P010015|S185|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD|OJX|CV|30-Day Notice||N|11/29/2012|12/26/2012|||OK30|ADDITIONAL SUPPLIER FOR EXTRUDED TUBING.
P060039|S040|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice||N|11/29/2012|12/26/2012|||OK30|ADDITIONAL SUPPLIER FOR EXTRUDED TUBING.
P830061|S083|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS + LEAD|NVY|CV|30-Day Notice||N|11/29/2012|12/26/2012|||OK30|ADDITIONAL SUPPLIER FOR EXTRUDED TUBING.
P920015|S101|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice||N|11/29/2012|12/26/2012|||OK30|ADDITIONAL SUPPLIER FOR EXTRUDED TUBING.
P930039|S079|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CASUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice||N|11/29/2012|12/26/2012|||OK30|ADDITIONAL SUPPLIER FOR EXTRUDED TUBING.
P030026|S027|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|12/21/2012|||OK30|CHANGE TO THE LIMITS OF AN IN-PROCESS TEST USED IN THE ASSESSMENT OF STREPTAVIDIN COATED WELLS, A COMPONENT OF THE DEVICE.
P100047|S005|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|03/04/2013|||APPR|APPROVAL TO OUTSOURCE THE MANUFACTURING OF MOTOR ASSEMBLIES TO A CONTRACT MANUFACTURER.
P100001|S005|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|12/21/2012|||OK30|CHANGE TO THE LIMITS OF AN IN-PROCESS TEST USED IN THE ASSESSMENT OF STREPTAVIDIN COATED WELLS, A COMPONENT OF THE DEVICE.
P090028|S006|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|12/21/2012|||OK30|CHANGE TO THE LIMITS OF AN IN-PROCESS TEST USED IN THE ASSESSMENT OF STREPTAVIDIN COATED WELLS, A COMPONENT OF THE DEVICE.
P980043|S037|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|12/28/2012|||OK30|CHANGE TO THE MACHINING PROCESS FOR STENTS.
P990064|S045|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|12/28/2012|||OK30|CHANGE TO THE MACHINING PROCESS FOR STENTS.
P100032|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|PRECICONTROL ANTI-HBC (ELECSYS) 2010|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P100047|S006|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/19/2012|||OK30|OUTSOURCING SEVERAL COMPONENTS OF THE HEARTWARE SYSTEM FOR THE POLISHING PROCESS.
P990012|S019|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|PRECICONTROL HBSAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P010054|S021|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|PRECICONTROL ANTI-HBS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P100047|S007|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/28/2012|||OK30|REDUCTIONS TO SAMPLING PLANS AND MODIFICATION TO INCOMING INSPECTION.
P110022|S009|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|PRECICONTROL ANTI-HBC IGM (COBAS E 601)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P110025|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|PRECICONTROL ANTI-HBC IGM (MODULAR ANALYTICS E170)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P110031|S008|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|PRECICONTROL ANTI-HBC IGM (COBAS E 411)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P930029|S038|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF ENCHANCER II ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/21/2012|||OK30|TRANSFER INCOMING INSPECTION ACTIVITIES.
P090007|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P090008|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P090009|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P100031|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/20/2012|||OK30|TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
P050018|S018|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER - RAPID EXCHANGE (RX), ANGIOSCULPT PTCS SCORING BALLOON CATHETER - EASY EXCHAN|NWX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/30/2012|05/20/2013|||APPR|APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE LABELING.
P990056|S019|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA CALSET|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/26/2012|||OK30|TRANSFER FROM PACKAGING LINE 20 IN BUILDING 398, TO PACKAGING LINE 19 IN BUILDING 493 WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABEL SIZE, AND LABEL LAYOUT.
P050006|S033|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELIX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/26/2012|||OK30|ALTERNATE RESIN RAW MATERIAL FOR THE DEVICE.
P860057|S099|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2012|12/28/2012|||OK30|ADDITION OF TWO NEW FLOW TESTERS.
P100047|S008|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2012|01/07/2013|||OK30|IMPLEMENTATION OF A MODIFIED POLISHING/ BUFFING PROCESS FOR THE COATED IMPELLERS, WHICH ARE USED WITH THE DEVICE.
P000039|S047|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/30/2012|12/19/2012|||APPR|APPROVAL FOR LABELING CHANGES REGARDING DEVICE EROSION.
P860004|S180|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE PUMP, MODEL 8637|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|11/30/2012|03/04/2013|||APPR|APPROVAL FOR A MODIFICATION TO THE SYNCHROMED II BATTERY CAPACITY SPECIFICATION.
P950037|S114|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA DR, EVIA SR, ENTOVIS DR, ENTOVIS SR, ESTELLA DR, ESTELLA SR, EFFECTA D, EFFECTA DR, EFFECTA S, EFFECTA SR, ECURO DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2012|12/19/2012|||OK30|ALTERNATE SUPPLIER FOR THE SNAP-CAN HOUSING.
P980022|S130|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2012|08/26/2013|||APPR|APPROVAL FOR INCORPORATION OF A NEW 300-TON PRESS FOR MOLDING CASE INSERT ASSEMBLY AND INCORPORATION OF A NEW ULTRASONIC WELDER FOR THE RETAINER RING.
P100047|S009|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSISTE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2012|12/18/2012|||OK30|USE OF ALTERNATE AUTOMATED INSPECTION EQUIPMENT FOR A CRITICAL COMPONENT.
P100013|S008|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2012|12/28/2012|||OK30|USE OF AN ALTERNATE COMPONENT SUPPLIER.
P790002|S029|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET BHS-MINI|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2012|12/31/2012|||OK30|NEW CRIMPING EQUIPMENT AND CRIMP CONNECTOR FOR THE BONE HEALING TREATMENT COILS.
P100022|S001|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/03/2012|06/03/2013|||APPR|APPROVAL FOR A PRODUCT LINE EXTENSION FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT. THIS LINE EXTENSION INCLUDES ADDITIONAL STENT LENGTHS OF 100MM AND 120MM.
P110021|S004|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/04/2012|07/02/2013|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE ASCENDRA BALLOON CATHETER, MODELS 9100BCL23 (23MM) AND 9100BCL26 (26MM), AND THE ASCENDRA INTRODUCER SHEATH SET, MODEL 91001S. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ASCENDRA 3 DELIVERY SYSTEM, MODELS 9120AS23 (23MM) AND 9120AS26 (26MM) AND ASCENDRA 3 INTRODUCER SHEATH SET, MODEL 9120IS (26F) AND IS INDICATEDFOR THE TRANSAPICAL DELIVERY OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (DELIVERY SYSTEM) AND FOR THE INTRODUCTION AND REMOVAL OF DEVICES USED WITH THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (INTRODUCER SHEATH SET).
P050034|S007|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE (IMT)|NCJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2012|12/27/2012|||OK30|IMPLEMENTATION OF A HOLDING SYSTEM USING NITROGEN GAS IN LASER WELDING SYSTEM I (LWSI).
P000025|S067|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/26/2012|12/05/2013|||APPR|APPROVAL FOR THE MAESTRO 4.1 SOFTWARE, AN UPDATED VERSION OF THE FITTINGSOFTWARE INTENDED FOR USE WITH THE MED-EL COCHLEAR IMPLANT SYSTEM.
P880086|S230|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track||N|12/05/2012|03/20/2014|||APPR|APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.
P100047|S011|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2012|01/03/2013|||OK30|RELOCATION OF OPERATIONS OF A CRITICAL SUPPLIER.
P030035|S108|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS|NIK|CV|Normal 180 Day Track||N|12/05/2012|03/20/2014|||APPR|APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.
P910023|S311|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track||N|12/05/2012|03/20/2014|||APPR|APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.
P030054|S241|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS|NIK|CV|Normal 180 Day Track||N|12/05/2012|03/20/2014|||APPR|APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.
P880006|S085|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track||N|12/05/2012|03/20/2014|||APPR|APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.
P970013|S055|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track||N|12/05/2012|03/20/2014|||APPR|APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.
P100047|S010|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2012|04/23/2013|||APPR|APPROVAL FOR RE-ROUTING THE THERMAL CUT-OUT WIRE AND SHORTENING THE THERMAL CUT-OUT ASSEMBLY LENGTH.
P040024|S065|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE L AND PERLANE L INJECTABLE GEL|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/04/2012|02/28/2013|||APPR|APPROVAL FOR A CHANGE TO THE PLUNGER ROD FOR THE 2.25 ML SYRINGE FOR RESTYLANE L AND PERLANE L INJECTABLE GEL (2 ML FILL SIZES).
P100047|S012|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2012|01/02/2013|||OK30|CHANGE IN SOFTWARE ALGORITHM TO CALCULATE IN-PROCESS VALUES.
P100047|S013|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2012|02/27/2013|||APPR|APPROVAL FOR ADDITION OF AN ALTERNATE LASER WELDING WORKSTATION AND TO BRING A LASER MARKING STEP IN-HOUSE.
P000040|S027|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2012|05/16/2013|||APPR|APPROVAL FOR A MANUFACTURING SITES LOCATED AT BOSTON SCIENTIFIC CORPORATION, IN SPENCER, INDIANA, AND BOSTON SCIENTIFIC CORPORATION, IN COVENTRY, RHODE ISLAND.
P110008|S002|PARADIGM SPINE, LLC|505 PARK AVENUE, 14TH  FLOOR||NEW YORK|NY|10022||Prosthesis, spinous process spacer/plate|COFLEX® INTERLAMINAR TECHNOLOGY|NQO|OR|Normal 180 Day Track No User Fee|Other Report|N|11/26/2012|04/23/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY.
P030017|S147|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2012|01/03/2013|||OK30|CHANGE TO THE METAL CASTING FRAME CLEANING PROCESS.
P030017|S148|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2012|06/28/2013|||APPR|APPROVAL FOR A CHANGE IN LOCATION OF YOUR IMPLANTABLE PULSE GENERATOR (IPG) CASE SUPPLIER.
P040037|S044|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2012|01/04/2013|||OK30|ALTERNATE RESIN RAW MATERIAL FOR THE DEVICES.
P100022|S002|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2012|10/16/2013|||APPR|
P050010|S014|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|SYNTHES PRODISC-L TOTAL DISC REPLACEMENT|MJO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/2012|05/28/2014|||APPR|APPROVAL TO ADD ADDITIONAL ENDPLATES AS A LINE EXTENSION.
P010015|S186|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P010031|S343|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P110042|S002|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/10/2012|03/07/2013|||APPR|APPROVAL FOR NEW SOURCES AND FORMULATIONS OF BATTERY CELL MATERIALS.
P930039|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P080006|S049|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P970008|S062|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|12/20/2012|||OK30|IMPLEMENTATION OF ALTERNATIVE POUCH SEALING EQUIPMENT FOR PACKAGING A COMPONENT OF THE DEVICE.
P050038|S012|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/09/2013|||OK30|CHANGE IN SHORT TERM STORAGE CONDITIONS IN THE POWDER FILLER FOR RELATIVE HUMIDITY CONTROLS AND THE ADDITION OF 100% WEIGHT INSPECTION POST FILLING.
P060039|S041|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P980016|S393|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P830061|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD, CAPSURE SENSE BIPOLAR LEAD, VISTATRON CRYSTALINE LEAD, VISTRATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P850089|S092|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P890003|S267|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P920015|S102|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT, SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|01/03/2013|||OK30|ALTERNATE SUPPLIERS FOR MULTIPLE SILICONE COMPONENTS.
P850079|S063|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2012|02/21/2014|||APPR|APPROVAL FOR THE MANUFACTURE OF THE DEVICE ON ANOTHER MANUFACTURING LINE AND FURTHER THAT ORDERS WITH LOW VOLUME REQUIREMENTS WILL BE LATHED ON THE FRONT SURFACE, RATHER THAN FULLY MOLDED AS LARGE VOLUME ORDERS ARE.
P910001|S063|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 EXCIMER LASER SYSTEM|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|01/08/2013|||OK30|ALTERNATE SUPPLIER FOR CABLE ASSEMBLIES.
P840001|S231|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS ACCESSORIES,SCS 1X8 EXTENSION,SCS QUADRIPOLAR EXTENSION,SCS LEADS SPECIFY FAMILY,SCS LEADS 1X8 FAMILY,SCS LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|01/08/2013|||OK30|USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION.
P860004|S181|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|DRUG DELIVERY ACCESSORIES,DRUG DELIVERY CATHETERS,DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY,DRUG DELIVERY KITS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|01/08/2013|||OK30|USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION.
P960009|S161|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS ACCESSORIES,DBS EXTENSIONS,DBS LEADS,DBS NEUROSTIMULATORS IMPLANTABLE,DBS NEUROSTIMULATORS SOLETRA FAMILY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|01/08/2013|||OK30|USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION.
P970004|S147|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY ACCESSORIES,SNS URINARY EXTENSIONS,SNS URINARY LEADS,SNS URINARY NEUOSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|01/08/2013|||OK30|USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION.
P080025|S043|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL ACCESSORIES,SNS BOWEL EXTENSIONS,SNS LEADS,SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY,SNS BOWEL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|01/08/2013|||OK30|USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION.
P910023|S312|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ATLAS/ATLAS+, ATLAS II/ATLAS II+, CURRENT, CURRENT ACCEL, CURRENT+, EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|04/23/2013|||APPR|APPROVAL FOR THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.
P030054|S242|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ATLAS+ HF/ATLAS II HF, ATLAS II+ HF, EPIC+, EPIC II HF, EPIC II+HF, PROMOTE, PROMOTE+, PROMOTE, RF, PROMOTE ACCEL, UNIFY|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|04/23/2013|||APPR|APPROVAL FOR THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.
P020055|S005|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/2012|03/20/2013|||APPR|APPROVAL FOR A CHANGE FROM FLUORINATED BOTTLES TO NON-FLUORINATED BOTTLES FOR STORAGE OF THE AQUEOUS GENERAL PURPOSE REAGENTS USED IN THE STAINING WITH THE PATHWAY ANTI-C-KIT (9.7)  RABBIT MONOCLONAL PRIMARY ANTIBODY.
P040024|S066|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|02/28/2013|||OK30|PROPOSED MODIFICATION TO THE AUTOCLAVE REQUALIFICATION STRATEGY IN FACTORY 1 AND FACTORY 2.
P860004|S182|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|THE SYNCHROMED II IMPLANTABLE PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|01/08/2013|||OK30|IN-PROCESS INSPECTION STEP BE IMPLEMENTED.
P880086|S231|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|04/23/2013|||APPR|APPROVAL FOR THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.
P030035|S109|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-P DEVICES|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2012|04/23/2013|||APPR|APPROVAL FOR THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.
P010012|S317|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA, COGNIS CRT-D'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2012|01/10/2013|||OK30|ADDITION OF AN INSPECTION AT THE SUPPLIER AND UPDATES TO THE CRYSTAL COMPONENT DRAWING.
P080011|S020|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COOPERVISION COMFILCON A SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2012|01/09/2013|||OK30|CHANGE TO USE A NEW MOLD MATERIAL FOR THE MANUFACTURE OF COMFILCON A EXTENDED-WEAR CONTACT LENSES.
P960040|S283|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA, TELIGEN ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2012|01/10/2013|||OK30|ADDITION OF AN INSPECTION AT THE SUPPLIER AND UPDATES TO THE CRYSTAL COMPONENT DRAWING.
P030005|S094|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2012|01/10/2013|||OK30|ADDITION OF AN INSPECTION AT THE SUPPLIER AND UPDATES TO THE CRYSTAL COMPONENT DRAWING.
P980031|S012|ADDITION TECHNOLOGY|820 OAK CREEK DRIVE||LOMBARD|IL|60148||Implant, corneal, refractive|INTACS CORNEAL IMPLANTS|LQE|OP|135 Review Track For 30-Day Notice||N|12/12/2012|06/03/2013|||APPR|TRANSFER OF DISTRIBUTION, PRODUCT RELEASE, SECONDARY LABELING AND PACKAGING, AND LIMITED SECONDARY LABELING AND SECONDARY PACKAGING REWORK OPERATIONS FROMTHE FIRMS CURRENT FACILITY TO ITS NEW FACILITY.
P120005|S001|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2012|01/04/2013|||OK30|SEMI-AUTOMATE THE SUB-ASSEMBLY DISPOSABLE SEAL (DS) PROCESS USED IN THE G4 CONTINUOUS GLUCOSE MONITORING SYSTEM.   ADDITIONALLY, A NEW CLEAN ROOM WAS ADDED TO ACCOMMODATE THE NEW DISPOSABLE SEAL MACHINE AND PROVIDE ADDITIONAL MANUFACTURING CAPACITY FOR THE OTHER PROCESSES.
P990064|S046|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice||N|12/13/2012|01/08/2013|||OK30|EXPANSION OF A CLEANROOM.
P980043|S038|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHETIC HEART VALVE|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|01/08/2013|||OK30|EXPANSION OF A CLEANROOM.
P790007|S034|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|01/08/2013|||OK30|EXPANSION OF A CLEANROOM.
P060023|S004|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|BRYAN CERVICAL DISC|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|01/11/2013|||OK30|USE OF A NEW LOCATION FOR THE POROUS COATING PROCESS PERFORMED AT THE FIRM¿S SUPPLIER.
P870078|S018|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|01/08/2013|||OK30|EXPANSION OF A CLEANROOM.
P970031|S038|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|01/08/2013|||OK30|EXPANSION OF A CLEANROOM.
P110042|S003|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2012|02/21/2013|||APPR|APPROVAL FOR SOFTWARE MAINTENANCE RELEASE (SMR6).
P950032|S070|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|03/10/2014|||APPR|APPROVAL OF AN ALTERNATE SOURCE OF A CRITICAL MATERIAL USED IN THE MANUFACTURE OF APLIGRAF.
P000037|S032|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|01/08/2013|||OK30|CHANGE THE SUSPENSION AGENT-TO-WATER MIXING RATIO OF POLISHING SLURRY OF THE VIBRATORY POLISH PROCESS.
P100022|S004|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/13/2012|03/01/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040037|S045|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|01/15/2013|||OK30|CHANGE IN RF BONDING PARAMETERS.
P050038|S013|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2012|01/10/2013|||OK30|QUALIFICATION OF ADDITIONAL MANUFACTURING EQUIPMENT.
P100022|S003|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/13/2012|02/15/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S101|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2012|01/08/2013|||OK30|SOFTWARE MODIFICATION TO THE AUTOMATED MIXING, STORAGE AND DELIVERY SYSTEM USED IN THE MANUFACTURE OF SEVERAL MODELS OF THE CARPENTIER-EDWARDS PERIMOUNT AORTIC AND MITRAL VALVE BIOPROSTHESES.
P000006|S029|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/14/2012|01/29/2013|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE TITAN NARROW BASECYLINDER (11 AND 14 CM LENGTHS ONLY): (I) CHANGE OF THE ANGLE OF THE TUBING FROM 22.5° TO 0°, AND (II) CHANGE IN CYLINDER TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750.
P860004|S184|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MODEL 8880CW MEDTRONIC NEUROMODULATION CLINICIAN PROGRAMMER|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2012|01/08/2014|||APPR|APPROVAL FOR THE RELEASE OF A CLINICAL SUMMARY FOR SYNCHROMED II CLINICAL ACCURACY.
P860057|S100|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2012|06/11/2013|||APPR|APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.
P870056|S056|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2012|06/11/2013|||APPR|APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.
P870077|S051|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2012|06/11/2013|||APPR|APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.
P000007|S038|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2012|06/11/2013|||APPR|APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.
P010041|S040|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2012|06/11/2013|||APPR|APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.
P110021|S005|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2012|06/11/2013|||APPR|APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.
P100041|S019|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/14/2012|06/11/2013|||APPR|APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.
P960016|S040|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2012|02/19/2013|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE MATERIALS IN THE EXTENSION CABLES COMPATIBLE WITH THE LIVEWIRE TC STEERABLE AND SAFIRE STEERABLE CARDIAC ABLATION CATHETERS.
P930039|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2012|01/15/2013|||OK30|REPLACEMENT OF LASER WELDING EQUIPMENT.
P030009|S062|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY RX CORONARY STENT SYSTEM, INTEGRITY OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2012|01/15/2013|||OK30|ADDITION OF A LEAK TESTER AND THE REMOVAL OF AN ACCEPTABLE QUALITY LIMIT TEST REQUIREMENT.
P010032|S065|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI LE CHARGER, EON MINI LE CHARGING SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2012|01/16/2013|||OK30|METHOD OF REMANUFACTURING OF THE CHARGER.
P100044|S004|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL SINUS IMPLANT|OWO|EN|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|12/14/2012|05/22/2013|||APPR|APPROVAL FOR A REVISED DRUG RELEASE SPECIFICATION RANGE FOR THE DRUG RELEASE TEST PER A CONDITION OF APPROVAL.
P920015|S103|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2012|01/15/2013|||OK30|RELOCATION AND REFURBISHMENT OF AN INJECTION MOLDING PRESS.
P030050|S013|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA, SCULPTRA AESTHETIC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2012|01/16/2013|||OK30|DOES NOT QUALIFY AS A SUPP. - CHANGES SUBMITTED IN NEXT ANNUAL REPORT.
P040008|S004|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2012|01/15/2013|||OK30|ADD A NEW QUALIFIED SUPPLIER FOR AN INCOMING RAW MATERIAL.
P950032|S071|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2012|03/14/2013|||APPR|APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELL STRAIN 157 (HEP 157) FOR USE IN THE MANUFACTURE OF APLIGRAF.
P020011|S006|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|APTIMA HCV RNA QUALITATIVE ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2012|01/09/2013|||OK30|MODIFICATION TO THE QUALITY CONTROL RELEASE TESTING FOR THE REAGENTS KITS.
P050023|S058|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2012|03/18/2013|||APPR|APPROVAL FOR THE ILESTO 7/5 VR-T ICD, ILESTO 7/5VR-T DX ICD, ILESTO 7/5 DR-T ICD, ILESTO 7/5 HFT CRT-D; IFORIA 7/5 VR-T ICD, IFORIA  7/5 VR-T DX ICD, IFORIA 7/5 DR-T ICD, IFORIA 7/5 HF-T CRT-D; AND THE PSW 1205.U.
P950037|S116|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2012|03/18/2013|||APPR|APPROVAL FOR THE ILESTO 7/5 VR-T ICD, ILESTO 7/5 VR-T DX ICD, ILESTO 7/5 DR-T ICD, ILESTO 7/5 HFT CRT-D; IFORIA 7/5 VR-T ICD, IFORIA 7/5 VR-T DX ICD, IFORIA 7/5 DR-T ICD, IFORIA 7/5 HF-T CRT-D; AND THE PSW 1205.U.
P000009|S051|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2012|03/18/2013|||APPR|APPROVAL FOR THE ILESTO 7/5 VR-T ICD, ILESTO 7/5 VR-T DX ICD, ILESTO 7/5 DR-T ICD, ILESTO 7/5 HFT CRT-D; IFORIA 7/5 VR-T ICD, IFORIA  7/5 VR-T DX ICD, IFORIA 7/5 DR-T ICD, IFORIA 7/5 HF-T CRT-D; AND THE PSW 1205.U.
P070008|S036|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T, EVIA AND ENTOVIS HF/HF-T CRT-P'S|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2012|03/18/2013|||APPR|APPROVAL FOR THE ILESTO 7/5 VR-T ICD, ILESTO 7/5 VR-T DX ICD, ILESTO 7/5 DR-T ICD, ILESTO 7/5 HFT CRT-D; IFORIA 7/5 VR-T ICD, IFORIA  7/5 VR-T DX ICD, IFORIA 7/5 DR-T ICD, IFORIA 7/5 HF-T CRT-D; AND THE PSW 1205.U.
P040012|S051|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2012|01/24/2013|||OK30|MANUFACTURING TRANSFER FOR THE DELIVERY SYSTEMS OF THE DEVICES WITHIN THE SAME SITE.
P080014|S015|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR, GENFIND DNA EXTRACTION KIT|MAQ|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/2012|04/18/2013|||APPR|APPROVAL FOR A MINOR LABELING CHANGE IN THE CERVISTA OPERATOR¿S MANUAL.
P080011|S021|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2012|01/17/2013|||OK30|RELOCATE AND REVALIDATE MANUFACTURING EQUIPMENT.
P010031|S344|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/2012|09/25/2013|||APPR|APPROVAL FOR ADDING NON-MEDTRONIC DEFIBRILLATION LEADS TO RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) LABELING.
P860004|S185|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE PUMP|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2012|11/09/2015|||APPR|APPROVAL FOR CHANGES IN MANUFACTURING AND REQUIREMENTS FOR SELECT MOTOR ASSEMBLY COMPONENTS OF THE SYNCHROMED II PUMP.
P000027|S017|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA CALSET|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2012|04/10/2013|||APPR|APPROVAL FOR A TRANSFER FROM PACKAGING LINE 20 IN BUILDING 398, TO PACKAGING LINE 19 IN BUILDING 493 WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABEL SIZE, AND LABEL LAYOUT.
P850079|S064|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2012|01/17/2013|||OK30|RELOCATE AND REVALIDATE MANUFACTURING EQUIPMENT.
P980016|S394|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA XT ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II ICD, MAXIMO II ICD|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/19/2012|09/25/2013|||APPR|APPROVAL FOR ADDING NON-MEDTRONIC DEFIBRILLATION LEADS TO RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) LABELING.
P040038|S028|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2012|01/24/2013|||OK30|MANUFACTURING TRANSFER FOR THE DELIVERY SYSTEMS OF THE DEVICES WITHIN THE SAME SITE.
P080004|S013|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|ISERT GEMETRIC|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2012|03/13/2013|||APPR|APPROVAL FOR THE MODEL 731 INTRAOCULAR LENS (IOL), WHICH ADDS ACONTROLLED POSITIVE SPHERICAL ABERRATION TO THE OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT® GEMETRIC¿ AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
P110028|S006|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2012|01/24/2013|||OK30|MANUFACTURING TRANSFER FOR THE DELIVERY SYSTEMS OF THE DEVICES WITHIN THE SAME SITE.
P110001|S010|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|RX HERCULINK ELITE RENAL STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2012|01/24/2013|||OK30|MANUFACTURING TRANSFER FOR THE DELIVERY SYSTEMS OF THE DEVICES WITHIN THE SAME SITE.
P020026|S086|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||Coronary drug-eluting stent|CYPHER SIROLIMUS-ELUTING CORONARY  STENT|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/17/2012|10/10/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050034|S008|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE|NCJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2012|01/22/2013|||OK30|MINOR CHANGES TO THE ROUTINE STERILIZATION PROCESS.
P030050|S014|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AESTHETIC|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/2012|05/28/2013|||APPR|APPROVAL FOR THE REVISION OF A PRECAUTION STATEMENT IN YOUR PRODUCT LABEL TO STATE: SCULPTRA AESTHETIC SHOULD ONLY BE USED BY A HEALTHCARE PRACTITIONER TRAINED TO CORRECT SHALLOW TO DEEP NASOLABIAL CONTOUR DEFICIENCIES AND OTHER FACIAL WRINKLES, IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE, AFTER THE HEALTHCARE PRACTITIONER IS FULLY FAMILIAR WITH THE PRODUCT, WAS, PRODUCT EDUCATIONAL MATERIALS, AND THE ENTIRE PACKAGE INSERT AND PATIENT LABELING.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCULPTRA AESTHETIC AND IS INDICATED FOR USE IN IMMUNE-COMPETENT PEOPLE AS A SINGLE REGIMEN FOR CORRECTION OF SHALLOW TO DEEP NASOLABIAL FOLD CONTOUR DEFICIENCIES AND OTHER FACIAL WRINKLES IN WHICH DEEP DERMAL GRID PATTERN (CROSS-HATCH) INJECTION TECHNIQUE IS APPROPRIATE.
P930014|S065|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2012|01/17/2013|||OK30|NEW CURING OVEN.
P040020|S044|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2012|01/17/2013|||OK30|NEW CURING OVEN.
P080014|S016|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR ASSAY|MAQ|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/20/2012|03/15/2013|||APPR|APPROVAL FOR A MINOR LABELING CHANGE TO THE PACKAGE INSERT OF THE DEVICE.
P100047|S014|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2012|05/15/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT HEARTWARE IN MIAMI LAKES, FLORIDA.
P100044|S005|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL MINI SINUS IMPLANT|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2012|01/17/2013|||OK30|CHANGE TO THE PACKAGING PROCESS.
P080011|S022|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2012|01/17/2013|||OK30|CHANGE IN THE SUPPLY CHAIN FOR THE RAW MATERIAL, USED IN THE MANUFACTURE OF COMFILCON A EXTENDED-WEAR CONTACT LENSES.
P940016|S015|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|H.E.L.P. PLASMAT FUTURA SYSTEM|MMY|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/20/2012|02/22/2013|||APPR|APPROVAL FOR AN INCREASE IN MEMBRANE LENGTH AND AN INCREASE INHOUSING LENGTH OF THE HEPARIN ADSORBER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEPARIN ADSORBER 400 AND IS INDICATED FOR USE AS A COMPONENT OF THE H.E.L.P FUTURA APHERESIS SYSTEM, USED FOR THE REMOVAL, BY IONIC EXCHANGE, OF EXCESS HEPARIN ADDED TO PRECIPITATE LIPOPROTEINS FROM PLASMA.
P920015|S104|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|01/17/2013|||OK30|IMPLEMENTATION OF A LABEL LASER MARKING PROCESS AND ADDITION OF A 2D MATRIX TO THE LABEL.
P980049|S078|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR AND DR, PARADYM RF VR AND DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|01/16/2013|||OK30|CHANGE TO THE GLUING EQUIPMENT.
P060027|S046|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D, PARADYM RF CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|01/16/2013|||OK30|CHANGE TO THE GLUING EQUIPMENT.
P970051|S103|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2012|03/21/2013|||APPR|APPROVAL FOR TE STERILE SILICONE TEMPLATE (SST) AS A SINGLE USE SURGICAL TOOL TO HELP CHECK THE SIZE OF THE PERIOSTEAL POCKET, THE SHAPE AND DEPTH OF THE IMPLANT WELL, AND APPROPRIATE POSITIONS FOR TIE-DOWN HOLES DURING THE IMPLANT SURGICAL PROCEDURE.
P000036|S014|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|02/28/2013|||APPR|APPROVAL FOR A CHANGE IN THE INTRA-UNIT SAMPLING REGIMEN FOR DERMAGRAFT ANALYTICAL RELEASE ASSAYS.
P100018|S005|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/21/2012|01/18/2013|||APPR|APPROVAL FOR REVISIONS AND ADDITIONAL WARNINGS TO THE INSTRUCTIONS FOR USE.
P030005|S096|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CARDIAC RESYNCHRONIZATION THERAPY - PACEMAKER (CRT-P)|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|01/15/2013|||OK30|NEW SETTINGS FOR MANUFACTURING EQUIPMENT.
P000058|S051|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|02/07/2013|||OK30|EXTENSION OF THE EXPIRY OF BATCH REFERENCE MATERIAL.
P950037|S117|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS DR-T,PHILOS II DR-T, CYLOS DR-T, EVIA DR-T,EVIA SR-T, ENTOVIS DR-T,ENTOVIS SR-T|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2012|01/31/2013|||APPR|APPROVAL FOR THE UPDATES TO THE HOME MONITORING SERVICE CENTER WITH 5 SOFTWARE VERSIONS, V3.8.1, V3.9.0, V3.10.0, V3.11.0, V3.12.0; AND THE CARDIOMESSENGER II9-LLT).
P000054|S036|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|02/07/2013|||OK30|EXTENSION OF THE EXPIRY OF BATCH REFERENCE MATERIAL.
P050053|S028|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|02/07/2013|||OK30|EXTENSION OF THE EXPIRY OF BATCH REFERENCE MATERIAL.
P980023|S050|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|BELOS VR-T|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2012|01/31/2013|||APPR|APPROVAL FOR THE UPDATES TO THE HOME MONITORING SERVICE CENTER WITH 5 SOFTWARE VERSIONS, V3.8.1, V3.9.0, V3.10.0, V3.11.0, V3.12.0; AND THE CARDIOMESSENGER II9-LLT).
P040045|S035|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|01/17/2013|||OK30|ALTERNATE NEW TEST METHOD FOR THE CONTACT ANGLE OF VISTAKON (SENOFILCON A) BRAND CONTACT LENSES.
P000009|S052|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS VR-T, BELOS DR-T, BELOS A +-T, LEXOS DR-T,LEXOS VR-T,XELOS DR-T, LUMOS DR-T,LUMOS VR-T|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2012|01/31/2013|||APPR|APPROVAL FOR THE UPDATES TO THE HOME MONITORING SERVICE CENTER WITH 5 SOFTWARE VERSIONS, V3.8.1, V3.9.0, V3.10.0, V3.11.0, V3.12.0; AND THE CARDIOMESSENGER II9-LLT)
P100023|S067|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|01/08/2013|||OK30|TWO SOFTWARE UPDATES TO THE MIDSHAFT HOT JAW BONDING PROCESS.
P050023|S059|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2012|01/31/2013|||APPR|APPROVAL FOR THE UPDATES TO THE HOME MONITORING SERVICE CENTER WITH 5 SOFTWARE VERSIONS, V3.8.1, V3.9.0, V3.10.0, V3.11.0, V3.12.0; AND THE CARDIOMESSENGER II9-LLT)
P110010|S043|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2012|01/08/2013|||OK30|TWO SOFTWARE UPDATES TO THE MIDSHAFT HOT JAW BONDING PROCESS.
P070008|S037|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2012|01/31/2013|||APPR|APPROVAL FOR THE UPDATES TO THE HOME MONITORING SERVICE CENTER WITH 5 SOFTWARE VERSIONS, V3.8.1, V3.9.0, V3.10.0, V3.11.0, V3.12.0; AND THE CARDIOMESSENGER II9-LLT)
P010032|S066|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI IMPLANTABLE PULSE GENERATOR|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2012|03/15/2013|||APPR|APPROVAL FOR DESIGN CHANGES TO THE HEADER OF EON MINI IMPLANTABLEPULSE GENERATOR (IPG), MODEL 3788.
P080032|S012|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/26/2012|07/03/2013|||APPR|APPROVAL FOR 1) THE MANUFACTURING TRANSFER OF THE ALAIR CATHETER FROM THE CURRENT FACILITY IN SUNNYVALE, CALIFORNIA, TO THE BOSTON SCIENTIFIC FACILITY IN CORK, IRELAND; AND 2) THE QUALIFICATION OF SYNERGY HEALTH IRELAND LTD, LOCATED IN TULLAMORE, IRELAND, AS A STERILIZATION SITE FOR THE ALAIR CATHETER, AND MINOR DESIGN CHANGES TO THE ALAIR CATHETER.APPROVAL FOR 1) THE MANUFACTURING TRANSFER OF THE ALAIR CATHETER FROM THE CURRENT FACILITY IN SUNNYVALE, CALIFORNIA, TO THE BOSTON SCIENTIFIC FACILITY IN CORK, IRELAND; AND 2) THE QUALIFICATION OF SYNERGY HEALTH IRELAND LTD, LOCATED IN TULLAMORE, IRELAND, AS A STERILIZATION SITE FOR THE ALAIR CATHETER, AND MINOR DESIGN CHANGES TO THE ALAIR CATHETER.
P960040|S284|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|01/22/2013|||OK30|CHANGES TO THE SPUTTERED CERAMIC LAPPING PROCESS USED DURING FEEDTHRU ASSEMBLY.
P010012|S318|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONICATION THERAPY-DEBIBRILLATOR,ENERGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|01/22/2013|||OK30|CHANGES TO THE SPUTTERED CERAMIC LAPPING PROCESS USED DURING FEEDTHRU ASSEMBLY.
P920047|S054|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|01/22/2013|||OK30|TRANSFER OF THE ENDOTOXIN (LAL) TESTING TO A NEW LOCATION.
P020025|S037|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP AND BLAZER II XP CARDIAC ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|01/22/2013|||OK30|TRANSFER OF THE ENDOTOXIN (LAL) TESTING TO A NEW LOCATION.
P030017|S151|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SOINAL CORD STIMULATOR SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|01/16/2013|||OK30|ALTERNATE GRINDER WITH AUTOMATIC FEATURES FOR THE SPINAL CORD STIMULATOR.
P080026|S005|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|02/07/2013|||OK30|CHANGE TO THE EXISTING LABEL PRINT AND INSPECTION EQUIPMENT WITH 2 NEW LABEL PRINTERS, NEW LABEL PRINTING SOFTWARE, AND A NEW LABEL INSPECTION SYSTEM THAT IS USED TO PRINT AND INSPECT LABELS FOR ALL MANUFACTURED PARTS AT ABBOTT MOLECULAR INC. IN DES PLAINES, ILLINOIS.
P810032|S063|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA  MULTI-PIECE POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|07/23/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN LESAGE, WEST VIRGINIA.
P840060|S039|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE POSTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|07/23/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN LESAGE, WEST VIRGINIA.
P880087|S021|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA ANTERIOR CHAMBER IOLS|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|07/23/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN LESAGE, WEST VIRGINIA.
P930014|S066|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES (IOLS)|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|07/23/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN LESAGE, WEST VIRGINIA.
P040020|S045|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS|MFK|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|07/23/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN LESAGE, WEST VIRGINIA.
P900056|S119|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ARTHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|01/24/2013|||OK30|AUTOMATION OF AN ENVIRONMENTAL MONITORING SYSTEM AT THE HEREDIA, COSTA RICA FACILITY.
P040044|S046|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE  PRODUCT FAMILY|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|01/24/2013|||OK30|ADDITION OF A TWO ¿SHELF FREEZE DRYER.
P050047|S030|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/2012|03/11/2013|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF-LIFE FROM 18 MONTHS TO 20MONTHS FOR THE 1ML SYRINGE; AN INCREASE IN THE ONOETHYLGLYCINEXYLIDIDE (MEGX) IMPURITY SPECIFICATION FROM 2.5% TO 3.5% W/W OF THE LABEL STRENGTH AND TOTAL IMPURITIES FROM 3.0% TO 4.3% OF LABEL STRENGTH.
P100044|S006|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL MINI SINUS IMPLANTS|OWO|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2012|06/10/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE AT INTERSECT ENT, MENLO PARK, CALIFORNIA.
P990002|S002|ROCHESTER MEDICAL CORP.|ONE ROCHESTER MEDICAL DR.||STEWARTVILLE|MN|55976||Transurethral occlusion insert, urinary incontinence-control, female|FEMSOFT URETHRAL INSERT|OCK|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/2012|03/21/2013|||APPR|APPROVAL FOR LABELING MODIFICATIONS.
P070014|S037|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/28/2012|05/31/2016|16M-1455|06/03/2016|APPR|Approval for the Bard® LifeStent® Vascular Stent System.  The Bard® LifeStent® Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 to 6.5 mm.
P080027|S008|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2012|01/24/2013|||OK30|CHANGE IN THE PRESERVATIVE USED IN THE MANUFACTURE OF THE DEVICE.
P860047|S027|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT HPMC VISCOELASTIC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2012|01/29/2013|||OK30|ADDITION OF AN ALTERNATE DILUENT FOR ENDOTOXIN TESTING.
P040044|S047|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX ACE VASCULAR CLOSURE DEVICE (6F/7F)|MGB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/31/2012|08/19/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE DELIVERY SYSTEM THAT COMPOSES THE MYNXGRIP VASCULAR CLOSURE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNX ACE VASCULAR CLOSURE DEVICE ("MYNX ACE") AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIALACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH.
P020056|S018|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|12/31/2012|03/05/2015|||APPR|APPROVAL FOR UPDATED LABELING TO INCLUDE 10 YEAR DATA FROM THE CORE CLINICAL STUDY.
P880081|S038|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|PHACO-FLEX AND TECHIS CL SILICONE ULTRAVIOLENT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2012|01/29/2013|||OK30|
P910077|S130|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MULTIPLE APPLICATION UTILITY (MAU) USED WITH ZOOM LATITIDE PROGRAMMING SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/03/2013|02/12/2013|||APPR|APPROVAL FOR THE MULTIPLE APPLICATION UTILITY (MAU), SOFTWARE VERSION 8.02.
P010014|S041|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM-TIBIAL TRAYS|NRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2013|02/14/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOMET, INC., IN WARSAW, INDIANA.
P970038|S020|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2013|02/06/2013|||OK30|CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE.  THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.
P850048|S031|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE IMMUNOASSAY SYSTEMS|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2013|02/06/2013|||OK30|CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE.  THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.
P090026|S004|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2013|02/06/2013|||OK30|CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE.  THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.
P980041|S021|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2013|02/06/2013|||OK30|CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE.  THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.
P110010|S044|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/04/2013|01/30/2013|||OK30|REDUCTION IN SAMPLE SIZE USING ANALYTICAL CHEMISTRY METHODS FOR IDENTIFYING EVEROLIMUS, AND FOR DETERMINING DEGRADATION AND IMPURITIES.
P910073|S115|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE, ENDOTAK RELIANCE 4-SITE|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/04/2013|02/14/2013|||APPR|APPROVAL FOR LABELING CHANGES FOR THE DEVICES.
P860057|S102|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES WITH THERMAFIX TISSUE PROCESS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2013|01/30/2013|||OK30|ADDITION OF TWO LITER JAR TORQUE MACHINE.
P100041|S020|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2013|01/30/2013|||OK30|ADDITION OF TWO LITER JAR TORQUE MACHINE.
P110021|S006|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2013|01/30/2013|||OK30|ADDITION OF TWO LITER JAR TORQUE MACHINE.
P080012|S010|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2013|01/22/2013|||OK30|ADDITION OF AN ALTERNATE SUB-TIER SUPPLIER OF A COMPONENT OF THE DEVICE.
P000006|S030|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/08/2013|02/25/2013|||APPR|APPROVAL FOR 1) THE ADDITION OF A LOCKING NUT INSERT TO THE NARROW REAR TIP EXTENDERS (RTES); AND 2) CHANGE IN THE PACKAGING CONFIGURATION OF THIS COMPONENT.
P060029|S005|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Sealant,polymerizing|ETHICON OMNEX SURGICAL SEALANT|NBE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/08/2013|01/17/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHICON, INC., IN CORNELIA, GEORGIA.
P010012|S319|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY SPIRAL LEAD|LWP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/09/2013|03/08/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110021|S007|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2013|02/08/2013|||OK30|CHANGES AFFECTING THE SUPPLIERS OF THE RAW MATERIALS FOR POLYPROPYLENE MONOFILAMENT THREAD, POLYETHYLENE TEREPHTHALATE WOVEN RIBBON, AND VESTAMID RESIN.
P100041|S021|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2013|02/08/2013|||OK30|CHANGES AFFECTING THE SUPPLIERS OF THE RAW MATERIALS FOR POLYPROPYLENE MONOFILAMENT THREAD, POLYETHYLENE TEREPHTHALATE WOVEN RIBBON, AND VESTAMID RESIN.
P050039|S015|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2013|02/07/2013|||OK30|ADDITIONAL MANUFACTURING EQUIPMENT.
P110042|S004|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/11/2013|02/21/2013|||APPR|APPROVAL FOR A CHANGE TO THE PATIENT SCREENING INSTRUCTIONS IN THE SQ-RX PULSE GENERATOR USER MANUAL.
P990081|S015|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/14/2013|03/20/2013|||APPR|APPROVAL FOR A CHANGE FROM FLUORINATED BOTTLES TO NON-FLUORINATED BOTTLES FOR STORAGE OF THE GENERAL PURPOSE REAGENTS USED IN THE STAINING WITH THE PATHWAY AND ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY.
P000058|S052|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/13/2013|||OK30|ADDITION OF AN ALTERNATIVE WATER SUPPLIER.
P950020|S060|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566||CORONARY FLEXTONE CUTTING BALLOON||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/12/2013|||OK30|ALTERNATE INSPECTION EQUIPMENT FOR THE EXTRUDED TUBING COMPONENT.
P000054|S037|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/13/2013|||OK30|ADDITION OF AN ALTERNATIVE WATER SUPPLIER.
P050053|S029|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/13/2013|||OK30|ADDITION OF AN ALTERNATIVE WATER SUPPLIER.
P950037|S118|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA DR, EVIA DR-T,EVIA SR, EVIA SR-T,ENTOVIS DR, ENTOVIS DR-T,ENTOVIS SR,ENTOVIS SR-T,ESTELLA SR,ESTELLA SR-T,ECURO DR,|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/19/2013|||OK30|RECLASSIFYING THE ENVIRONMENTAL CONDITIONS FROM CLASS D TO ISO 8 CLEANROOMS.
P980023|S051|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|KAINOX VCS,SLX 58/11-BP,SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,LINOX S 65,LINOX S 75, LINOX T 65,LINOX T75,|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/19/2013|||OK30|RECLASSIFYING THE ENVIRONMENTAL CONDITIONS FROM CLASS D TO ISO 8 CLEANROOMS.
P860003|S069|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS|LNR|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/14/2013|02/15/2013|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO INCLUDE A WARNING STATEMENT REGARDING THE USE OF THE DEVICE ON THE SAME DAY AS OTHER PROCEDURES THAT MAY CAUSE SIGNIFICANT FLUID CHANGES IN A PATIENT.
P050023|S060|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|COROX OTW 85 UP STEROID, LUMAX 300 DR-T, LUMAX 340 DR-T,LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T,LUMAX 540 DR-T, L|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/19/2013|||OK30|RECLASSIFYING THE ENVIRONMENTAL CONDITIONS FROM CLASS D TO ISO 8 CLEANROOMS.
P070008|S038|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV,EVIA HF,EVIA HF-T,ENTOVIS HF,ENTOVIS HF-T,COROX OTW 85 UP STEROID,COROX OTW 75-BP,COROX OTW 85-BP,COROX OTW-S|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/19/2013|||OK30|RECLASSIFYING THE ENVIRONMENTAL CONDITIONS FROM CLASS D TO ISO 8 CLEANROOMS.
P980035|S303|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/07/2013|||OK30|MANUFACTURING CHANGES AT THE MEDTRONIC SINGAPORE OPERATIONS (MSO) MANUFACTURING FACILITY: PROTEUS 3.6 AND SELF-TEST 3.3 FINAL FUNCTION TESTIER UPDATE, SQM VERSION 3.3.3, FACOTRYWORKS VERSION 7.8, AATS VERSION 5.0 UPDATE, AND THERMAL PROCESSING OF EPOXY RESIN.
P830061|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE BIPOLAR LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/07/2013|||OK30|MANUFACTURING CHANGES AT THE MEDTRONIC SINGAPORE OPERATIONS (MSO) MANUFACTURING FACILITY: PROTEUS 3.6 AND SELF-TEST 3.3 FINAL FUNCTION TESTIER UPDATE, SQM VERSION 3.3.3, FACOTRYWORKS VERSION 7.8, AATS VERSION 5.0 UPDATE, AND THERMAL PROCESSING OF EPOXY RESIN.
P090013|S082|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/07/2013|||OK30|MANUFACTURING CHANGES AT THE MEDTRONIC SINGAPORE OPERATIONS (MSO) MANUFACTURING FACILITY: PROTEUS 3.6 AND SELF-TEST 3.3 FINAL FUNCTION TESTIER UPDATE, SQM VERSION 3.3.3, FACOTRYWORKS VERSION 7.8, AATS VERSION 5.0 UPDATE, AND THERMAL PROCESSING OF EPOXY RESIN.
P930039|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/07/2013|||OK30|MANUFACTURING CHANGES AT THE MEDTRONIC SINGAPORE OPERATIONS (MSO) MANUFACTURING FACILITY: PROTEUS 3.6 AND SELF-TEST 3.3 FINAL FUNCTION TESTIER UPDATE, SQM VERSION 3.3.3, FACOTRYWORKS VERSION 7.8, AATS VERSION 5.0 UPDATE, AND THERMAL PROCESSING OF EPOXY RESIN.
P110028|S007|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2013|02/12/2013|||OK30|ALIGN CLEAN ROOM ACTION LIMITS WITH A NEW STANDARD.
P930031|S041|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2013|02/14/2013|||OK30|ADDITION OF A REWORK STEP IN THE ELECTRO ETCH PROCESS.
P900056|S120|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2013|02/14/2013|||OK30|CHANGE TO THE TEMPERATURE OF THE STERILIZATION CYCLE.
P010029|S016|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2013|03/13/2013|||OK30|CHANGE IN THE CLASSIFICATION OF A MATERIALS WEIGHING ROOM.
P980033|S030|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2013|02/14/2013|||OK30|ADDITION OF A REWORK STEP IN THE ELECTRO ETCH PROCESS.
P960011|S022|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BV1 1% OVD (1% SODIUM HYALURONATE VISCCOELASTIC SURGICAL AID FLUID)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2013|03/13/2013|||OK30|CHANGE IN THE CLASSIFICATION OF A MATERIALS WEIGHING ROOM.
P020009|S102|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2013|02/14/2013|||OK30|CHANGE TO THE EXTRUSION MELT FILTER.
P060006|S040|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2013|02/14/2013|||OK30|CHANGE TO THE EXTRUSION MELT FILTER.
P040016|S107|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2013|02/14/2013|||OK30|CHANGE TO THE EXTRUSION MELT FILTER.
P030052|S011|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2013|02/10/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR HUMAN PLACENTAL (HP) DNA WHICH IS A COMPONENT OF THE PATHVYSION HER-2 DNA PROBE KIT AND THE UROVYSION BLADDER CANCER KIT.
P980024|S010|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2013|02/10/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR HUMAN PLACENTAL (HP) DNA WHICH IS A COMPONENT OF THE PATHVYSION HER-2 DNA PROBE KIT AND THE UROVYSION BLADDER CANCER KIT.
P970051|S104|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/16/2013|10/23/2013|||APPR|APPROVAL FOR THE FOLLOWING CHANGES: A MODIFICATION TO THE FREEDOM SOUND PROCESSOR, A CHANGE IN THE FREEDOM BODYWORN CABLE O-RING, A CHANGE TO FREEDOM BODYWORN CABLE CLIP, A CHANGE TO THE FREEDOM BATTERY PACK, A CHANGE TO THE FREEDOM RECHARGEABLE BATTERY,AND A MODIFICATION OF THE SURGICAL TOOL KIT INSTRUCTIONS FOR THE CI24RE AND CI422 SERIES IMPLANTS.
P860057|S103|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2013|02/14/2013|||OK30|USE OF PARAMETRIC RELEASE IN THE MANUFACTURE OF SEVERAL MODELS OF THE CARPENTIER-EDWARDS PERIMOUNT AORTIC AND MITRAL VALVE BIOPROSTHESES.
P960040|S285|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ICD PUNCTUA VR IS4|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2013|02/08/2013|||OK30|APPROVAL OF ADDITIONAL SPOTWELD EQUIPMENT.
P970003|S156|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY PULSE GENERATOR (DEMIPULSE AND DEMIPULSE DUO)|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2013|02/07/2013|||OK30|MANUFACTURING CHANGE FOR THE THERAPY GENERATORS.
P110019|S039|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2013|06/28/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR COSTA RICA (A VCR) IN EL COYO ALAJUELA, COSTA RICA.
P970004|S148|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2013|02/14/2013|||OK30|ALTERNATE SUPPLIERS FOR THE INTEGRATED CIRCUIT FOR THE INTERSTIM II IMPLANTABLE NEUROSTIMULATOR.
P080025|S044|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2013|02/14/2013|||OK30|ALTERNATE SUPPLIERS FOR THE INTEGRATED CIRCUIT FOR THE INTERSTIM II IMPLANTABLE NEUROSTIMULATOR.
P010012|S320|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ENERGEN CRT-D IS4|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2013|02/08/2013|||OK30|APPROVAL OF ADDITIONAL SPOTWELD EQUIPMENT.
P000006|S031|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2013|02/14/2013|||OK30|REPLACEMENT OF EXISTING TESTING EQUIPMENT USED IN THE MANUFACTURING PROCESS OF THE DEVICE.
P020050|S011|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM, ALLEGRO ANALYZER|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2013|04/12/2013|||APPR|APPROVAL TO INTRODUCE THE WAVENET¿ NETWORK SYSTEM TO FACILITATE DATA EXCHANGE BETWEEN FDA APPROVED/ CLEARED WAVELIGHT® REFRACTIVE/ THERAPEUTIC AND DIAGNOSTIC DEVICES VIA A NETWORK SERVER.
P030008|S010|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX 500 LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/18/2013|04/12/2013|||APPR|APPROVAL TO INTRODUCE THE WAVENET¿ NETWORK SYSTEM TO FACILITATE DATA EXCHANGE BETWEEN FDA APPROVED/ CLEARED WAVELIGHT® REFRACTIVE/ THERAPEUTIC AND DIAGNOSTIC DEVICES VIA A NETWORK SERVER.
P110010|S045|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2013|02/14/2013|||OK30|USE OF AN ALTERNATE IN-PROCESS INSPECTION.
P100023|S068|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/18/2013|02/14/2013|||OK30|USE OF AN ALTERNATE IN-PROCESS INSPECTION.
P070015|S106|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (RX & OTW), XIENCE NANO  EECSS (RX)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/20/2013|||OK30|SHORTEN THE SHELF-LIFE OF A SOLVENT USED FOR THE MANUFACTURING OF THE DEVICES.
P110019|S040|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME/ XIENCE PRIME LL / XIENCE EXPEDITION/ XIENCE EXPEDITION SV AND LL  EVEROLIMUS ELUTING CORONARY STENT SYTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/20/2013|||OK30|SHORTEN THE SHELF-LIFE OF A SOLVENT USED FOR THE MANUFACTURING OF THE DEVICES.
P110019|S041|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY SYSTEM, XIENC|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|04/25/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT ABBOTT NUTRITION IRELAND, IN SLIGO, IRELAND.
P030027|S006|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002|0000|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|06/20/2013|||APPR|APPROVAL TO REPLACE MANUAL WASHING OF CERAMIC COMPONENTS WITH AN AUTOMATED WASHER.
P840001|S232|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 4 NEUROSTIMULATOR, ITREL 3 NEUROSTIMULATOR, SYNERGY NEUROSTIMULATOR, SYNERGY VERSITREL NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/14/2013|||OK30|CHANGE TO THE CONNECTOR CLEANING TECHNOLOGY PROCESS.
P960009|S162|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC NEUROSTIMULATOR, SOLETRA NEUROSTIMULATOR, KINETRA NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/14/2013|||OK30|CHANGE TO THE CONNECTOR CLEANING TECHNOLOGY PROCESS.
P100012|S002|NUVASIVE, INC.|7475 LUSK BLVD||SAN DIEGO|CA|92121||PROSTHESIS, INTERVERTEBRAL DISC|PCM CERVICAL DISC|MJO|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/22/2013|03/29/2013|||APPR|APPROVAL FOR LABELING CHANGES TO THE PATIENT BROCHURE.
P970004|S149|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM NEUROSTIULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/14/2013|||OK30|CHANGE TO THE CONNECTOR CLEANING TECHNOLOGY PROCESS.
P080025|S045|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/14/2013|||OK30|CHANGE TO THE CONNECTOR CLEANING TECHNOLOGY PROCESS.
P000006|S032|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/21/2013|||OK30|USE A NEW PIECE OF EQUIPMENT IN THE MANUFACTURING DRYING PROCESS.
P980035|S304|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/07/2013|||OK30|ACCEPTANCE OF AN UPGRADE TO TEST SYSTEM SOFTWARE SHELL.
P010015|S187|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/07/2013|||OK30|ACCEPTANCE OF AN UPGRADE TO TEST SYSTEM SOFTWARE SHELL.
P010031|S345|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/07/2013|||OK30|ACCEPTANCE OF AN UPGRADE TO TEST SYSTEM SOFTWARE SHELL.
P090013|S083|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/07/2013|||OK30|ACCEPTANCE OF AN UPGRADE TO TEST SYSTEM SOFTWARE SHELL.
P980016|S395|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/07/2013|||OK30|ACCEPTANCE OF AN UPGRADE TO TEST SYSTEM SOFTWARE SHELL.
P010012|S321|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (CRT-D)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/20/2013|||OK30|CHANGE IN THE DESIGNATION OF THE ANODE FOIL CHLORIDE CONTENT SPECIFICATION FROM THE DESIGN SPECIFICATION TO THE PERFORMANCE SPECIFICATION.
P960040|S286|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2013|02/20/2013|||OK30|CHANGE IN THE DESIGNATION OF THE ANODE FOIL CHLORIDE CONTENT SPECIFICATION FROM THE DESIGN SPECIFICATION TO THE PERFORMANCE SPECIFICATION.
P020024|S037|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER II|MAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/22/2013|08/18/2013|||APPR|APPROVAL FOR THE SECOND GENERATION AMPLATZER DUCT OCCLUDER II (ADO II) DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPLATZER DUCT OCCLUDER II AND IS INDICATED FOR THE NON-SURGICAL CLOSURE OF PATENT DUCTUS ARTERIOSIUS (PDA).
P100047|S015|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2013|02/19/2013|||OK30|INSTALLATION OF A NEW LABEL PRINTER.
P980041|S022|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|01/23/2013|03/25/2013|||APPR|APPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE DILUENT AND ACCESS HYBRITECH PSA SAMPLE DILUENT AND ACCESS SUBSTRATE FOR ACCESS AFP, ACCESS HYBRITECH PSA, ACCESS HYBRITECH FREE PSA AND ACCESS HYBRITECH P2PSA.
P970038|S021|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|01/23/2013|03/26/2013|||APPR|PPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE DILUENT AND ACCESS HYBRITECH PSA SAMPLE DILUENT AND ACCESS SUBSTRATE FOR ACCESS AFP, ACCESS HYBRITECH PSA, ACCESS HYBRITECH FREE PSA AND ACCESS HYBRITECH P2PSA.
P850048|S032|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|01/23/2013|03/26/2013|||APPR|PPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE DILUENT AND ACCESS HYBRITECH PSA SAMPLE DILUENT AND ACCESS SUBSTRATE FOR ACCESS AFP, ACCESS HYBRITECH PSA, ACCESS HYBRITECH FREE PSA AND ACCESS HYBRITECH P2PSA.
P090026|S005|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM|OYA|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|01/23/2013|03/26/2013|||APPR|PPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE DILUENT AND ACCESS HYBRITECH PSA SAMPLE DILUENT AND ACCESS SUBSTRATE FOR ACCESS AFP, ACCESS HYBRITECH PSA, ACCESS HYBRITECH FREE PSA AND ACCESS HYBRITECH P2PSA.
P950029|S073|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2013|03/12/2013|||APPR|APPROVAL FOR AN ALTERNATE FEEDTHROUGH COMPONENT.
P970003|S157|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|PERENNIADURA MODEL 303 LEAD|MUZ|NE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2013|04/03/2013|||APPR|APPROVAL FOR MINOR DESIGN AND MANUFACTURING CHANGES TO THEPERENNIADURA MODEL 303 LEAD.
P110016|S006|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2013|04/18/2013|||APPR|APROVAL FOR A MODIFIED CATHETER USING A TIP ELECTRODE WITH 12 IRRIGATION HOLES FROM THE CURRENTLY APPROVED SAFIRE BLU DUO BI-DIRECTIONAL ABLATION CATHETER WITH THE SHAFT AND HANDLE OF THE CURRENTLY APPROVED THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY COOL PATH DUO BI-DIRECTIONAL CATHETER AND IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND 1500T9 CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
P080012|S011|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2013|04/09/2013|||APPR|APPROVAL FOR ADDITIONAL PRINTER DRIVER FOR THE PROMETRA PROGRAMMABLEPUMP SYSTEM PROGRAMMER SOFTWARE.
P920047|S055|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2013|02/22/2013|||OK30|AUTOMATE THE TEMPERATURE, HUMIDITY, AND DIFFERENTIAL PRESSURE MONITORING SYSTEM AT THE HEREDIA, COSTA RICA FACILITY.
P020025|S038|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP RF ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2013|02/22/2013|||OK30|AUTOMATE THE TEMPERATURE, HUMIDITY, AND DIFFERENTIAL PRESSURE MONITORING SYSTEM AT THE HEREDIA, COSTA RICA FACILITY.
P860003|S070|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2013|02/19/2013|||OK30|MANUFACTURING PROCESS CHANGE TO APPLY A CURRENTLY USED UV CURABLE ADHESIVE IN AN ADDITIONAL LOCATION WITHIN THE CELLEX PHOTOPHERESIS PROCEDURAL KIT.
P030053|S013|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Real-Time Process||N|01/25/2013|02/24/2014|||APPR|APPROVAL FOR THE ADDITION OF SEVEN STYLES INCLUDING FOUR SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5650BC, 350-57000BC, 350-5750BC, AND 350-5800BC; AND THREE SILTEX ROUND ULTRA HIGH PROFILE DEVICES: 354-5590, 354-5650, AND 354-5700.
P100012|S003|NUVASIVE, INC.|7475 LUSK BLVD||SAN DIEGO|CA|92121||PROSTHESIS, INTERVERTEBRAL DISC|NUVASIVE'S PCM CERVICAL DISC|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/19/2012|04/10/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980035|S305|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2013|02/26/2013|||OK30|CHANGE TO THE COMPONENT INJECTION MOLDING PROCESS FOR THE CONNECTOR MODULE.
P110014|S001|DUNE MEDICAL DEVICES INC|111 SPEEN ST SUITE 101||FRAMINGHAM|MA|01701||Diagnostic low electric field|MARGINPROBE SYSTEM|OEE|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/25/2013|04/29/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110010|S046|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/25/2013|02/21/2013|||OK30|ADDITION OF SOFTWARE CONTROLS TO THE SECONDARY PACK SEALER.
P090016|S005|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2013|02/14/2013|||OK30|NEW EVALUATION PROCESS FOR OUT OF SPECIFICATION RESULTS.
P100028|S003|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|STENT, RENAL|FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM|NIN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/28/2013|03/28/2014|||APPR|APPROVAL FOR AN ADDITIONAL DELIVERY SYSTEM (FORMULA 535 DELIVERY SYSTEM) FOR THE FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM.
P010032|S067|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|TRIPOLE 16 AND 16C (C-SERIES) SPINAL CORD STIMULATION LEADS, EXCLAIM SPINAL CORD STIMULATION LEADS, LAMITRODE 4, 44, 44C|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2013|10/15/2013|||APPR|APPROVAL TO INCREASE THE UPPER LIMIT OF THE GROOVE WIDTH AND DEPTH ON THE PENTA ELECTRODE.
P910056|S014|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER IOL|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2013|05/15/2013|||APPR|ADDITION OF AN ALTERNATE PACKAGING COMPONENT SUPPLIER FOR THE ENVISTA INTRAOCULAR LENS MODEL MX60 VIAL PACKAGE.
P980022|S131|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|IPRO2 RECORDER, IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2013|03/22/2013|||APPR|APPROVAL FOR THE ADDITION OF A ZERO-OHM RESISTOR TO THE IPRO2 RECORDER (MMT-7741) CIRCUIT BOARD. THE IPRO2 RECORDER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM.
P110035|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2013|02/20/2013|||OK30|USE OF NEW EXTRUSION EQUIPMENT.
P040016|S108|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2013|02/20/2013|||OK30|USE OF NEW EXTRUSION EQUIPMENT.
P060006|S041|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2013|02/20/2013|||OK30|USE OF NEW EXTRUSION EQUIPMENT.
N18033|S068|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A)|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2013|02/27/2013|||OK30|IMPLEMENTATION OF AN ALTERNATE INJECTION MOLDING MACHINE.
P040045|S036|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A)|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2013|02/27/2013|||OK30|IMPLEMENTATION OF AN ALTERNATE INJECTION MOLDING MACHINE.
P010015|S188|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2013|02/27/2013|||OK30|CHANGES TO THE ACCELEROMETER ACTIVITY TEST SYSTEM.
P980035|S306|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2013|02/27/2013|||OK30|CHANGES TO THE ACCELEROMETER ACTIVITY TEST SYSTEM.
P090022|S015|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HDO|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2013|02/26/2013|||OK30|ADDITIONAL LENS ANALYZER.
P970029|S024|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM|MNO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/29/2013|05/31/2013|||APPR|APPROVAL FOR DESIGN CHANGES TO THE DISTAL FIBERS OF THE THREE HAND-PIECE MODELS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMR2000 HOLMIUM LASER SYSTEM AND IS INDICATED FOR TRANS-MYOCARDIAL REVASCULARIZATION IN PATIENTS WITH ANGINA REFRACTORY TO MEDICAL TREATMENT AND SECONDARY TO OBJECTIVELY DEMONSTRATED CORONARY ARTERY ATHEROSCLEROSIS AND WITH A REGION OF THE MYOCARDIUM WITH REVERSIBLE ISCHEMIA NOT AMENABLE TO DIRECT CORONARY REVASCULARIZATION.
P030017|S152|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/28/2013|08/26/2014|||APPR|APPROVAL FOR THE ADDITION OF THE COVEREDGE 4X8 SURGICAL LEAD (ALSO REFERRED TO AS THE 32 CONTACT PADDLE LEAD) AND PADDLE BLANKS TO BE USED WITH THE PRECISION SPECTRA SPINAL CORD STIMULATION SYSTEM.
P100044|S007|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL AND PROPEL MINI SINUS IMPLANT|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2013|02/27/2013|||OK30|CHANGES TO TWO QUALITY CONTROL TEST METHODS.
P100034|S003|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOTTF-100A SYSTEM|NZK|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/29/2013|04/17/2013|||APPR|APPROVAL FOR SOFTWARE MODIFICATION TO ADD AN ALARM TO THE IDLE LOOP (THE NON-TREATMENT LOOP) TO INDICATE THAT THE DEVICE IS STILL POWERED ON EVEN WHEN TREATMENT IS NOT ACTIVE.
P110035|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2013|02/20/2013|||OK30|PROCESS CHANGE WITHIN THE EXPANSION AND HEAT SETTING PROCESS FOR THE EPIC STENTS.
P100040|S010|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2013|02/28/2013|||OK30|USE OF AN ALTERNATE TESTING FIXTURE AND ALTERNATE TEST PROCEDURE.
P910001|S064|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2013|02/28/2013|||OK30|CHANGE TO THE PROCESS FOR MONITORING THE ETHYLENE OXIDE STERILIZATION PROCESS.
P960042|S046|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2013|02/28/2013|||OK30|CHANGE TO THE PROCESS FOR MONITORING THE ETHYLENE OXIDE STERILIZATION PROCESS.
P060001|S019|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS/RX CAROTID STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2013|02/27/2013|||OK30|ADDITION OF ALTERNATE SUPPLIER FOR RAW NITINOL TUBING.
P110010|S047|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2013|02/21/2013|||OK30|SOFTWARE AND HARDWARE UPGRADES TO THE INTEGRATED CRIMP AND CONE PUFF MACHINES.
P910023|S313|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT+,EPIC II/EPIC II+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2013|02/25/2013|||OK30|ALTERNATE SUPPLIER FOR ENCAPSULATION MATERIAL.
P030054|S243|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE+, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMILY OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2013|02/25/2013|||OK30|ALTERNATE SUPPLIER FOR ENCAPSULATION MATERIAL.
P040024|S068|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2013|03/01/2013|||OK30|PROPOSED INTRODUCTION OF A NEW PROCESS VESSEL USED IN THE BULK AND FILLING PROCESS IN FACTORY 2.
P120006|S003|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/31/2013|04/21/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050037|S035|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2013|02/22/2013|||OK30|NEW RAW MATERIAL SUPPLIERS.
P050052|S038|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2013|02/22/2013|||OK30|NEW RAW MATERIAL SUPPLIERS.
P100025|S004|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR|OZA|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2013|05/29/2013|||APPR|APPROVAL FOR CHANGES TO THE LABELING FOR THE BREATHTEK® UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0, INCLUDING THE PACKAGE INSERT AND HOW TO GUIDE.
P960016|S041|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|08/22/2013|||APPR|APPROVAL FOR CHANGES TO 1) UPDATE THE MANUFACTURING PROCEDURE TO ALLOW FOR THE USE OF A MOTORIZED STYLET FEEDER TO PUSH THE STYLET THROUGH THE CATHETER LUMEN FOR ELECTRODE STRINGING; AND 2) ADD AN ADDITIONAL STRINGING STYLET OPTION TO THE MANUFACTURING PROCEDURE.
P010031|S346|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|02/25/2013|||OK30|UPDATE TO THE ACCEPTANCE CRITERION FOR PERCENT DELAMINATION ON ALL DIE.
P010031|S347|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|02/25/2013|||OK30|ADDITION OF A SPECIFIC CRITERION TO ALLOW DELAMINATION FOR THE LOWER WIRE BOND PAD ON THE U31 FET.
P100023|S069|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|05/15/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BALLYBRIT BUSINESS PARK, IN GALWAY, IRELAND.
P080012|S012|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|04/19/2013|||APPR|APPROVAL FOR A WAREHOUSING AND DISTRIBUTION SITE LOCATED IN MANSFIELD, MASSACHUSETTS.
P970003|S158|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY ACCESSORY PACK|MUZ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2013|05/02/2013|||APPR|APPROVAL FOR A NEW TORQUE WRENCH MODEL FEATURING A RECESSED NOSE DESIGN
P030017|S153|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|02/26/2013|||OK30|LASER MARKING THE SERIAL NUMBER ON THE RETENTION SLEEVE.
P840001|S233|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS EXTERNAL, SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY, SCS NEUROSTIMULATORS IMPLANTABLE RESTORE|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|02/25/2013|||OK30|UPDATE TO THE LTX TEST SYSTEM SHELL SOFTWARE.
P860004|S186|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|02/25/2013|||OK30|UPDATE TO THE LTX TEST SYSTEM SHELL SOFTWARE.
P030036|S053|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL|NVY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/01/2013|02/28/2013|||APPR|APPROVAL FOR 2 CONTENT CHANGES IN THE SELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL.
P960009|S164|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS NEUROSTIMULATORS EXTERNAL, DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2013|02/25/2013|||OK30|UPDATE TO THE LTX TEST SYSTEM SHELL SOFTWARE.
P010031|S348|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||D286 CURRENT DRAIN LIMITS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|02/28/2013|||OK30|CHANGE TO THE CURRENT DRAIN RELATED LIMITS FOR AN IC TO PREVENT EXCESSIVE YIELD FALLOUT.
P960016|S042|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWARE TC ABLATION CATHETER|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|07/18/2013|||APPR|APPROVAL TO UPDATE THE PROCESS PARAMETERS IN THE MANUFACTURING PROCEDURE FOR A NEW INJECTION MOLD.
P100017|S004|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|03/01/2013|||OK30|CHANGE TO THE CONFIGURATION OF THE CURRENT LABEL PRINTER, LABEL PRINTING SOFTWARE, AND LABEL INSPECTION SYSTEM AT THE DES PLAINES, ILLINOIS MANUFACTURING SITE.
P010031|S349|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|02/28/2013|||OK30|TWO PROCESS ADJUSTMENT CHANGES FOR THE INTEGRATED CIRCUIT AT A MEDTRONIC SUPPLIER.
P050019|S013|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|03/05/2013|||OK30|REMOVAL OF A REDUNDANT OFF-LINE INSPECTION FOR EXTRUDED COMPONENTS USED TO MANUFACTURE THE CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS.
P090003|S021|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|03/05/2013|||OK30|REMOVAL OF A REDUNDANT OFF-LINE INSPECTION FOR EXTRUDED COMPONENTS USED TO MANUFACTURE THEEXPRESS LD ILIAC PREMOUNTED STENT SYSTEM.
P100023|S070|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|03/05/2013|||OK30|REMOVAL OF A REDUNDANT OFF-LINE INSPECTION FOR EXTRUDED COMPONENTS USED TO MANUFACTURE THE ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM.
P110010|S048|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STEN SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|03/05/2013|||OK30|REMOVAL OF A REDUNDANT OFF-LINE INSPECTION FOR EXTRUDED COMPONENTS USED TO MANUFACTURE THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM .
P100010|S022|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT AND ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2013|06/07/2013|||APPR|APPROVAL FOR MINOR UPDATES TO THE COMPONENT SPECIFICATION OF THEBILUMEN VACUUM TUBE.
P960058|S102|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/04/2013|08/19/2013|||APPR|APPROVAL FOR THE NAIDA CI Q70 SOUND PROCESSOR, A SMALLER BEHIND THE EAR (BTE) SOUND PROCESSOR THAT HAS WIRELESS CONNECTIVITY. THE SUPPLEMENT ALSO INCLUDES A COMPLEMENTARY SET OF ACCESSORIES, A NEW CLINICIANS PROGRAMMING INTERFACE, AND A NEW VERSION OF THE SOUNDWAVE FITTING SOFTWARE.
P960040|S287|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA ICD, TELIGEN ICD, ENERGEN ICD, INCEPTA ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2013|03/07/2013|||OK30|MOVING THREE COMPONENT RECEIVING ACCEPTANCE ACTIVITIES FROM THE FIRM TO THE COMPONENT SUPPLIER.
P010012|S322|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA CRT-D, COGNIS CRT-D, ENERGEN CRT-D, INCEPTA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2013|03/07/2013|||OK30|MOVING THREE COMPONENT RECEIVING ACCEPTANCE ACTIVITIES FROM THE FIRM TO THE COMPONENT SUPPLIER.
P010030|S040|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|135 Review Track For 30-Day Notice||N|02/05/2013|06/25/2013|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE SUPPLIER OF AN ELECTRODE COMPONENT USED IN THE DEVICE.
P010031|S351|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2013|02/28/2013|||OK30|UPDATE TO THE AUTOMATED TEST EQUIPMENT SOFTWARE THAT TESTS AN IC TO IMPROVE MANUFACTURING YIELDS.
P040045|S037|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A)|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2013|03/05/2013|||OK30|ALTERNATE AUTOMATIC INSPECTION LENS SYSTEM.
N18033|S069|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A)|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2013|03/05/2013|||OK30|ALTERNATE AUTOMATIC INSPECTION LENS SYSTEM.
P010031|S352|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2013|02/28/2013|||OK30|IMPLEMENTATION OF ADDITIONAL TOOLING FOR THE CASE LINER ASSEMBLY MANUFACTURING PROCESS.
P040047|S025|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2013|03/08/2013|||OK30|NEW RAW MATERIAL SUPPLIERS.
P050023|S061|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2013|03/25/2013|||APPR|APPROVAL FOR MINOR CHANGES AND LABELING UPDATES TO THE CARDIOMESSENGER FAMILY OF DEVICES.
P950037|S119|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ECURO, EFFECTA, ENTOVIS, ESTELLA, EVIA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2013|03/25/2013|||APPR|APPROVAL FOR MINOR CHANGES AND LABELING UPDATES TO THE CARDIOMESSENGER FAMILY OF DEVICES.
P070008|S039|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/05/2013|03/25/2013|||APPR|APPROVAL FOR MINOR CHANGES AND LABELING UPDATES TO THE CARDIOMESSENGER FAMILY OF DEVICES.
P010031|S353|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2013|03/05/2013|||OK30|CHANGE TO THE HYBRID CD SURGE MANUFACTURING TEST SOFTWARE.
P010031|S355|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2013|02/28/2013|||OK30|CHANGE TO THE HYBRID BURN-IN TIME.
P970004|S150|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/2013|04/18/2014|||APPR|APPROVAL FOR MEDTRONIC¿S VERIFY¿ EVALUATION SYSTEM, WHICH IS A TEST STIMULATION SYSTEM CONSISTING OF THE MODEL 3537 CONTROLLER, THE MODEL 3531 VERIFY EXTERNAL NEUROSTIMULATOR (ENS), AND ASSOCIATED CABLES (MODELS 3575 AND 3576) AND ACCESSORIES.
P080025|S046|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/2013|04/18/2014|||APPR|APPROVAL FOR MEDTRONICS VERIFY EVALUATION SYSTEM, WHICH IS A TEST STIMULATION SYSTEM CONSISTING OF THE MODEL 3537 CONTROLLER, THE MODEL 3531 VERIFY EXTERNAL NEUROSTIMULATOR (ENS), AND ASSOCIATED CABLES (MODELS 3575 AND 3576) AND ACCESSORIES.
P000039|S048|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND AMPLATZER CRIBIFORM OCCLUDER|MAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/2013|10/29/2014|||APPR|APPROVAL FOR CONVERTING THE NITINOL WIRE USED IN THE MANUFACTURE OF THESE DEVICES FROM A BLACK OXIDE SURFACE FINISH TO A CHEMICALLY ETCHED SURFACE FINISH.
P980022|S132|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2013|03/01/2013|||OK30|UPDATE TO THE DRIVE SUPPORT DISK DISPENSING PROCESS AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY FOR THE PARADIGM MMT-7XX SERIES.
P010031|S354|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM)||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2013|03/07/2013|||OK30|THREE CHANGES INCLUDING THE IMPLEMENTATION OF A BURN-IN OVEN FOR THE RECOVERY AND FINAL VOLTAGE MEASUREMENTS STEPS FOR THE BATTERIES OF THE SUBJECT CRT-D SYSTEMS, CORRECTIONS TO THE SUBJECT SYSTEMS¿ BATTERY TEST SPECIFICATION TO ALIGN WITH MEASUREMENT SYSTEM CAPABILITIES, AND CONSOLIDATION OF MEASUREMENT STEPS WITHIN THE BURN IN TEST PROCESS.
P110042|S005|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2013|05/09/2013|||APPR|APPROVAL FOR DISABLING OF THE PROGRAMMER MODEL Q-TECH MODEMPORT.
P040008|S005|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2013|03/08/2013|||OK30|ADD AN ALTERNATE AUTOMATED PURIFICATION PROCESS TO SCALE-UP THE ANTI-PSA ANTIBODIES PRODUCTION USED IN THE MANUFACTURE OF THE VIDAS® TOTAL PSA (TPSA) ASSAY.
P040040|S022|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER VSD MUSCULAR OCCLUDER|MLV|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/2013|10/29/2014|||APPR|APPROVAL FOR CONVERTING THE NITINOL WIRE USED IN THE MANUFACTURE OF THESE DEVICES FROM A BLACK OXIDE SURFACE FINISH TO A CHEMICALLY ETCHED SURFACE FINISH.
P020024|S038|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER (ADO)|MAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/06/2013|10/29/2014|||APPR|APPROVAL FOR CONVERTING THE NITINOL WIRE USED IN THE MANUFACTURE OF THESE DEVICES FROM A BLACK OXIDE SURFACE FINISH TO A CHEMICALLY ETCHED SURFACE FINISH.
P840001|S234|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE ULTRA NEUROSTIMULATOR, RESTORE SENSOR NEUROSTIMULATOR, ITREL 4 NEUROSTIMULATOR AND ENTERNAL NEUROSTIMULATOR|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2013|06/19/2013|||APPR|APPROVAL FOR FIRMWARE CHANGES INTENDED TO CORRECT DEVICE BEHAVIORS THAT RESULT IN TEMPORARY LOSS OF STIMULATION (EXCEPTION BIT) AND CAN AFFECT PROGRAMMED STIMULATION PARAMETERS (OVER-DISCHARGE).
P010031|S356|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA/VIVA S/VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2013|03/05/2013|||OK30|(1) FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1; (2) MODIFICATION OF CONTROLLED ENVIRONMENT AREA; (3) NEW PRESSURE TESTER AT SMO FACILITY; AND (4) TEMPORARY GOWNING AREA AND TEMPORARY WALLS AND RELOCATION OF THE MILLING ROOM.
P860004|S187|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|N VISION PROGRAMMER|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2013|06/18/2013|||APPR|APPROVAL FOR N VISION PROGRAMMER (MODEL 8840) AND N VISION SOFTWARE APPLICATION CARD (MODEL 8870).
P010031|S357|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2013|03/07/2013|||OK30|MULTIPLE MANUFACTURING CHANGES PREVIOUSLY ACCEPTED FOR OTHER MARKET RELEASED MEDTRONIC DEVICES, WHICH INCLUDED: 1) CMOS PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATES TO THE TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS; 3) ADDITION OF HIGH TEMPERATURE MONITORING TO THE HIGH POWER LEAN LINE; 4) UPDATE TO A MANUFACTURING ASSEMBLY CONTROLLER SYSTEM; 5) IMPLEMENTATION OF A NEW CLEANING PROCESS AND CURING OVEN; AND 6) AND IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P960009|S165|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA RC NEUROSTIMULATOR AND EXTERNAL NEUROSTIMULATOR|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2013|06/19/2013|||APPR|APPROVAL FOR FIRMWARE CHANGES INTENDED TO CORRECT DEVICE BEHAVIORS THAT RESULT IN TEMPORARY LOSS OF STIMULATION (EXCEPTION BIT) AND CAN AFFECT PROGRAMMED STIMULATION PARAMETERS (OVER-DISCHARGE).
P980035|S308|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA MRI|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2013|03/07/2013|||OK30|MULTIPLE MANUFACTURING CHANGES PREVIOUSLY ACCEPTED FOR OTHER MARKET RELEASED MEDTRONIC DEVICES, WHICH INCLUDED: 1) CMOS PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATES TO THE TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS; 3) ADDITION OF HIGH TEMPERATURE MONITORING TO THE HIGH POWER LEAN LINE; 4) UPDATE TO A MANUFACTURING ASSEMBLY CONTROLLER SYSTEM; 5) IMPLEMENTATION OF A NEW CLEANING PROCESS AND CURING OVEN; AND 6) AND IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
P970051|S105|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2013|10/23/2013|||APPR|ADDITIONAL SUPPLIER OF A COMPONENT AND ADDITIONAL SPECIFICATIONS ON CLEANING, PACKAGING AND INSPECTION OF THESE COMPONENTS.
P880047|S020|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2013|03/12/2013|||OK30|CHANGE IN THE CONFIGURATION OF THE STERILIZATION PALLET USED FOR STERILIZING THE DEVICE.
P000032|S039|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|03/05/2013|||OK30|ADDITION OF A NEW GAS SUPPLIER AND THE TRANSFER OF CRIMPING OPERATIONS TO A DIFFERENT FACILITY.
P000032|S040|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice||N|02/08/2013|03/14/2013|||OK30|CHANGE OF RAW MATERIAL RESIN.
P840001|S235|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION (ITREL SYNERGY, SYNERGY VERSITREL, RESTOREPRIME, RESTORE ADVANCED, PRIME ADVANCED RESTOR ULTRA,|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|06/17/2013|||APPR|APPROVAL FOR A CHANGE TO A SOFTWARE-BASED SYSTEM FOR INCOMING INSPECTION.
P960009|S166|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEPP BRAIN STIMULATION ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|06/17/2013|||APPR|APPROVAL FOR A CHANGE TO A SOFTWARE-BASED SYSTEM FOR INCOMING INSPECTION.
P910077|S131|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE PATIENT MANAGEMENT SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2013|04/30/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE MODEL 6430 AC POWER ADAPTER.
P030017|S154|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|03/08/2013|||OK30|UPDATE THE TEST EQUIPMENT SYSTEM USED FOR THE TESTING OF THE IMPLANTABLE PULSE GENERATOR (IPG) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).
P010021|S024|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|03/05/2013|||OK30|CHANGE TO A QC TEST METHOD.
P010031|S358|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVIA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|03/07/2013|||OK30|IMPLEMENTATION OF ADDITIONAL LASER WELDERS TO INCREASE MANUFACTURING CAPACITY.
P970004|S151|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|06/17/2013|||APPR|APPROVAL FOR A CHANGE TO A SOFTWARE-BASED SYSTEM FOR INCOMING INSPECTION.
P970008|S063|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|03/05/2013|||OK30|SUPPLIER CHANGE FOR ONE OF THE COOLWAVE SYSTEM COMPONENTS.
P080025|S047|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR BOWEL CONTROL|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2013|06/17/2013|||APPR|APPROVAL FOR A CHANGE TO A SOFTWARE-BASED SYSTEM FOR INCOMING INSPECTION.
P050042|S022|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P050051|S020|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P960040|S288|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBTILLATOR, TELIGEN IMPLANTABLE CARIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARDI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/07/2013|||OK30|MODIFICATION TO THE CAPACITOR EPOXY PROCESS.
P080023|S020|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P060035|S019|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P060007|S026|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P010012|S323|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D), PUNTUA CRT-D, COOGINS, ENERGEN CRT-D, INCEPTA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/07/2013|||OK30|MODIFICATION TO THE CAPACITOR EPOXY PROCESS.
P110029|S011|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P030011|S019|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|05/30/2013|||APPR|APPROVAL FOR EXPANSION OF YOUR CONTROLLED ENVIRONMENT SUITE MANUFACTURING AREA.
P950029|S074|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT SR/DR PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/12/2013|||OK30|NEW AUTOMATED OPTICAL INSPECTION EQUIPMENT TO BE USED DURING THE MICRO ELECTRONIC PROCESS.
P980049|S079|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR AND PARADYM RF VR/DR ICD'S|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/12/2013|||OK30|NEW AUTOMATED OPTICAL INSPECTION EQUIPMENT TO BE USED DURING THE MICRO ELECTRONIC PROCESS.
P060027|S047|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM AND PARADYM RF CRT-D'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/12/2013|||OK30|NEW AUTOMATED OPTICAL INSPECTION EQUIPMENT TO BE USED DURING THE MICRO ELECTRONIC PROCESS.
P980007|S030|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P910007|S039|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P120008|S001|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2013|03/13/2013|||OK30|CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
P010030|S041|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2013|04/16/2013|||APPR|APPROVAL FOR MINOR MECHANICAL DESIGN MODIFICATIONS TO IMPROVE THE RUGGEDNESS OF THE LIFEVEST MODEL 4000 BATTERY CHARGER AND A MINOR MECHANICAL CHANGE TO THE MODEL 3000 BATTERY PACK.
P010030|S042|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/2013|07/22/2013|||APPR|APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE WCD 4000 LIFEVEST® WEARABLE DEFIBRILLATOR AND THE SUBSEQUENT DISPLAY OF THAT INFORMATION ON THE SECURE LIFEVEST.
P910077|S132|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE COMMUNICATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/13/2013|||OK30|MECHANICAL MODIFICATION TO FLEXIBLE PRINTED CIRCUITS AND MODIFICATIONS TO THE SOLDERING PROCESS PARAMETERS FOR THOSE CIRCUITS.
P040008|S006|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/13/2013|||OK30|ADDITION OF AN ALTERNATE ALKALINE PHOSPHATASE (ALP) FROM THE SAME QUALIFIED SUPPLIER; IT ALSO PROPOSED AN IMPROVEMENT TO THE QUALITY CONTROLS PERFORMED ON THISMATERIAL.
P860057|S104|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDSPERIMOUNT THEON PERCARDIAL AORTIC BIOPRO|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/12/2013|||APPR|APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.
P100041|S022|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/12/2013|||APPR|APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.
P110021|S008|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/12/2013|||APPR|APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.
P870056|S057|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/12/2013|||APPR|APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.
P870077|S052|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINBE MITRAL BIOPROSTHESIS|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/12/2013|||APPR|APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.
P000007|S039|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2013|03/12/2013|||APPR|APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.
P010041|S041|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/12/2013|||APPR|APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.
P980040|S042|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1-PIECE LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2013|03/07/2013|||OK30|NEW IOL PRODUCTION LINE, TEMPORARY CLEAN/INSPECT/INSERT AREA, A MODIFIED DEIONIZED WATER LOOP SUPPORT AREA AND A MODIFIED COMPRESSED AIR SYSTEM LOOP SUPPORT PRODUCTION AREA.
N18033|S070|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2013|03/07/2013|||OK30|MODIFICATION TO THE RELEASE TEST METHOD.
P100003|S001|GLOBUS MEDICAL INC.|2560 GENERAL ARMISTEAD AVE.||AUDUBON|PA|19403||PROSTHESIS, INTERVERTEBRAL DISC|SECURE -C CERVICAL ARTIFICIAL DISC|MJO|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/13/2013|03/15/2013|||APPR|APPROVAL FOR A MINOR MODIFICATION OF THE NARROW IMPLANT HOLDER (PART #614.805).
P860057|S105|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2013|03/12/2013|||OK30|INSTALLATION OF A NEW EXHAUST SYSTEM FOR A CLEANROOM.
P900056|S121|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2013|05/23/2013|||APPR|APPROVAL FOR USE OF AN ALTERNATE PROCESSING AID IN THE MANUFACTURE OF THE RESIN USED TO MAKE THE INNER PTFE LINER IN THE SLIDE TUBE COMPONENT OF THE ROTALINK ADVANCER.
P830055|S130|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2013|03/15/2013|||OK30|MANUFACTURING CHANGE TO THE FINISHING PROCESS.
P970031|S039|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2013|03/13/2013|||OK30|ADDITION OF A NEW PORCINE HEART VALVE TISSUE SUPPLIER.
P990064|S047|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2013|03/13/2013|||OK30|ADDITION OF A NEW PORCINE HEART VALVE TISSUE SUPPLIER.
P980043|S039|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2013|03/13/2013|||OK30|ADDITION OF A NEW PORCINE HEART VALVE TISSUE SUPPLIER.
P790007|S035|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2013|03/13/2013|||OK30|ADDITION OF A NEW PORCINE HEART VALVE TISSUE SUPPLIER.
P110010|S050|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2013|07/15/2013|||APPR|APPROVAL FOR AN UPGRADE TO AN INSPECTION SYSTEM CAMERA AND SOFTWARE.
P030017|S155|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice||N|02/15/2013|03/15/2013|||OK30|USE ALTERNATE BIOLOGICAL INDICATORS FOR MONITORING ETHYLENE OXIDE STERILIZATION.
P010031|S359|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA DF4 ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2013|03/13/2013|||OK30|ALTERNATE SUPPLIER OF A SILICONE COMPONENT.
P980016|S396|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2013|03/13/2013|||OK30|ALTERNATE SUPPLIER OF A SILICONE COMPONENT.
P050042|S023|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2013|03/13/2013|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P080023|S021|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2013|03/13/2013|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P060035|S020|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2013|03/13/2013|||OK30|ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P020045|S046|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CRYOABLATION CONSOLE|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/15/2013|03/06/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS CORPORATION, IN BUFFALO GROVE, ILLINOIS.
P030011|S020|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/15/2013|06/26/2014|||APPR|APPROVAL FOR THE FREEDOM® DRIVER SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART WITH THE FREEDOM® DRIVER SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES WHO HAVE BEEN IMPLANTED WITH THE TAH-T AND ARE CLINICALLY STABLE.
P980049|S080|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM/PARADYM RF ICD|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/15/2013|03/26/2013|||APPR|APPROVAL FOR UPDATES TO THE ORCHESTRA/ORCHESTRA PLUS PROGRAMMER SOFTWARE APPLICATIONS THAT ARE USED TO INTERROGATE AND PROGRAM THE PARADYM AND PARADYM RF FAMILY OF ICDS AND CRT-D DEVICES.
P060027|S048|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM/PARADYM RF CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/15/2013|03/26/2013|||APPR|APPROVAL FOR UPDATES TO THE ORCHESTRA/ORCHESTRA PLUS PROGRAMMER SOFTWARE APPLICATIONS THAT ARE USED TO INTERROGATE AND PROGRAM THE PARADYM AND PARADYM RF FAMILY OF ICDS AND CRT-D DEVICES.
P080026|S006|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|HBV ASSAY|MKT|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/15/2013|10/15/2013|||APPR|APPROVAL FOR 1) THE ADDITION OF AN OPTIONAL EXTENDED USE FEATURE TO ALLOW PREPARED AMPLIFICATION MASTER MIX AND INTERNAL CONTROL TO BE USED SECOND TIME WITHIN 14 DAYS OF INITIAL USE IF STORED AT 2°C TO 8°C; 2) IMPROVEMENTS TO THE PREPARATION AND PROCESSING STEPS OF THE AMPLIFICATION MASTER MIX BY THE ABBOTT M2000SP INSTRUMENT; AND 3) ASSOCIATED SOFTWARE REVISIONS.
P980053|S014|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INECTABLE BULKING AGENT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|03/21/2013|||OK30|MODIFICATION TO THE FOIL POUCH SEALER, AND THE ADDITION OF TWO ALTERNATE SEALERS, AND TWO NEW LABEL PRINTING SYSTEMS.
P980025|S002|CARESTREAM DENTAL LLC|1765 THE EXCHANGE||ATLANTA|GA|30339||Analyzer,medical image|LOGICON CARIES DETECTOR|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/2013|07/22/2014|||APPR|APPROVAL FOR THE ADDITION OF SOFTWARE MODULE PRESCAN TO LOGICON CARIES DETECTOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LOGICON CARIES DETECTOR AND HAS REVISED INDICATIONS FOR USE: THE LOGICON CARIES DETECTOR IS A SOFTWARE DEVICE THAT IS AN AID IN THE DIAGNOSIS OF CARIES THAT HAVE PENETRATED INTO THE DENTIN, ON UN-RESTORED PROXIMAL SURFACES OF SECONDARY DENTITION THROUGH THE STATISTICAL ANALYSIS OF DIGITAL INTRA-ORAL RADIOGRAPHIC IMAGERY. THE DEVICE PROVIDES ADDITIONAL INFORMATION FOR THE CLINICIAN TO USE IN HIS/HER DIAGNOSIS OF A TOOTH SURFACE SUSPECTED OF BEING CARIOUS. IT IS DESIGNED TO WORK IN CONJUNCTION WITH AN EXISTING CARESTREAM DENTAL RVG DIGITAL X-RAY RADIOGRAPHIC SYSTEM WITH DENTAL IMAGING SOFTWARE (DIS) FOR WINDOWS XP OR HIGHER.
P030022|S023|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|08/01/2013|||APPR|APPROVAL FOR TWO CHANGES MADE BY AT A RAW MATERIAL SUPPLIER: 1) THE FORGING PROCESS OF THE R3 ACETABULAR SHELLS; AND 2) THE BLAST MEDIA USED FOR AN IN PROCESS BLAST OPERATION FOR THE SYNERGY FEMORAL STEMS.
P060002|S029|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|03/15/2013|||OK30|ADDITIONAL LASER CUTTING SYSTEM AS PART OF THE MANUFACTURING PROCESS FOR THE FLAIR® ENDOVASCULAR STENT GRAFT.
P110013|S007|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|02/19/2013|02/05/2014|||APPR|APPROVAL TO TIGHTEN THE IN-PROCESS POST-DRY DRUG WEIGHT SPECIFICATIONS TO +/-7% (93-107%), AND TO REDUCE THE CURRENT MANUFACTURING OVERAGE FROM 5% TO 3%.
P110019|S042|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|03/22/2013|||OK30|CHANGE THE PARTICULATE COUNT SAMPLING PLAN FOR THE XIENCE PRIME, XIENCE PRIME LL, AND XIENCE XPEDITION EECSS.
P080030|S007|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|03/21/2013|||OK30|CHANGE IN A QUALITY CONTROL TESTING PROCEDURE
P950029|S075|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY AND ESPIRIT FAMILY OF PACEMAKERS|NVZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|03/13/2013|||APPR|APPROVAL FOR REINFORCEMENT OF AN EXISTING 100% IN-PROCESS SCREENING STEP INTENDED TO BE APPLIED FOR A LIMITED QUANTITY OF THREE (3) IDENTIFIED LOTS.
P050028|S030|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/19/2013|05/03/2013|||APPR|APPROVAL FOR CHANGES TO THE TEST DEFINITION FILE (TDF) IN ORDER TO IMPLEMENT A NEW SAMPLE PREPARATION SEQUENCE FOR THE COBAS AMPLIPREP INSTRUMENT.
P010032|S068|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI 2.0 SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/19/2013|05/17/2013|||APPR|APPROVAL FOR CHANGES TO THE EON MINI IMPLANTABLE PULSE GENERATOR(IPG) MODEL 3788 SOFTWARE.
P000039|S049|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER-CRIBRIFORM|MAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|07/26/2013|||APPR|APPROVAL FOR AN ALTERNATE SOURCE OF ROUTINE BIOBURDEN AND STERILITY TESTING, AS WELL AS CHANGES TO THE BIOBURDEN TESTING PROTOCOL.
P080027|S009|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|03/21/2013|||APPR|APPROVAL FOR ADDING MORE REPLICATES IN QC TESTING PROCEDURES.
P020024|S039|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER|MAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|07/26/2013|||APPR|APPROVAL FOR AN ALTERNATE SOURCE OF ROUTINE BIOBURDEN AND STERILITY TESTING, AS WELL AS CHANGES TO THE BIOBURDEN TESTING PROTOCOL.
P040040|S023|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|07/26/2013|||APPR|APPROVAL FOR AN ALTERNATE SOURCE OF ROUTINE BIOBURDEN AND STERILITY TESTING, AS WELL AS CHANGES TO THE BIOBURDEN TESTING PROTOCOL.
P830055|S131|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2013|04/10/2013|||OK30|MANUFACTURING CHANGE FOR FEMORAL COMPONENTS.
P110037|S005|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST|PAB|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|03/21/2013|||APPR|APPROVAL FOR A CHANGE TO THE SOFTWARE TEST DEFINITION FILES.
P070006|S011|OXFORD IMMUNOTEC,LTD.|94C INNOVATION DRIVE||MILTON PARK, ABINGDON OXFORDSHIRE||OX14||Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test|T-SPOT .TB TEST|OJN|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|09/03/2013|||APPR|APPROVAL FOR A CHANGE TO REDUCE THE VOLUME OF COATING ANTIBODY FOR THE MICROCOAT GMBH (MICROCOAT) PLATES INCLUDED IN THE T-SPOT®.TB TEST KITS.
P100016|S001|AAREN SCIENTIFIC INC|4290 EAST BRICKELL STREET|BLDG A|ONTARIO|CA|91761||intraocular lens|AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2013|05/28/2013|||APPR|APPROVAL FOR A CHANGE TO THE TRADE NAME OF THE APPROVED LENSES AND LABELING CHANGES TO THE UNIT CARTON, INCLUDING A CHANGE TO THE COLOR SCHEME AND FORMAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AARIS ACRYLIC INTRAOCULAR LENS (IOL), MODELS EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
P120005|S002|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2013|02/03/2014|14M-0224|02/24/2014|APPR|APPROVAL FOR THE DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS DEVICE IS INDICATED FOR:THE DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES 2 TO 17 YEARS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION.THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P950029|S076|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT PACEMAKER FAMILY|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2013|03/14/2013|||OK30|MODIFICATIONS TO THE LASER WELDING PROGRAM.
P950029|S077|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT SR/DR PACEMAKERS|NVZ|CV|30-Day Notice||N|02/19/2013|03/20/2013|||OK30|INTRODUCTION OF AN ALTERNATE SUPPLIER FOR INTERNAL BLISTER PACKAGING.
P120008|S002|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP ASSAY|LOK|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/19/2013|08/27/2013|||APPR|APPROVAL FOR MIGRATION OF ARCHITECT AFP ASSAY TO THE ARCHITECT ISYSTEM FAMILY MEMBER, THE ARCHITECT IL000SR.
P010031|S360|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2013|03/20/2013|||OK30|MODIFICATION TO THE SEAM WELD PROCESS WHEN USING THE DL1 SEAM WELD EQUIPMENT.
P980016|S397|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2013|03/20/2013|||OK30|MODIFICATION TO THE SEAM WELD PROCESS WHEN USING THE DL1 SEAM WELD EQUIPMENT.
P030017|S156|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/20/2013|05/08/2013|||APPR|APPROVAL FOR A COLORANT CHANGE TO THE HUB PORTION OF THE INTRODUCER, ASURGICAL ACCESSORY FOR THE PRECISION SPINAL CORD STIMULATION SYSTEM THAT IS USED TO FACILITATE PLACEMENT OF A LEAD INTO THE EPIDURAL SPACE.
P890003|S268|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC REMOTE HOME MONITOR|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|04/23/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS(HANGZHOU) CO., LTD., IN HANGZHOU, ZHEJIANG, CHINA.
P980016|S398|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO DR, VIRTUOSO VR, SECURA DR AND MAXIMO II DR|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|04/23/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS(HANGZHOU) CO., LTD., IN HANGZHOU, ZHEJIANG, CHINA.
P010031|S361|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA CRT-D, MAXIMO II CRT-D, CONCERTO 11 CRT-D, CPMCERTP CRT-D||CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|04/23/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS(HANGZHOU) CO., LTD., IN HANGZHOU, ZHEJIANG, CHINA.
P090016|S006|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE, BELOTERO BALANCE (SAMPLE)|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|03/21/2013|||OK30|MODIFICATION TO A PRODUCT RELEASE ASSESSMENT AND CRITERIA FOR FIN ISHED DEVICES.
P980035|S309|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|03/20/2013|||OK30|IC MANUFACTURE TEST CHANGES FOR THE ADVISA DR IPG A4DR01, ADVISA MRI IPG A2DR01,CONSULTA CRT-P C4TR01, SYNCRA CRT-P C2TR01,  CONCERTO II CRT-D D274TRK, CONSULTA DF4 ICD D204TRM, CONSULTA ICD D224TRK,MAXIMO II CRT-D D264TRM, D284TRK, PROTECTA CRT-D D334TRG, D334TRM, PROTECTA XT CRT-D D314TRG, D314TRM,  MAXIMO II ICD D264DRM, D264VRM, D284DRG, D284VRC, PROTECTA ICDD334DRG, D334DRM, D334VRG, D334VRM, PROTECTA XT ICD D314DRG, D314DRM, D314VRG, D314VRM, SECURA ICD D204DRM, D204VRM, D224DRG, D224VRC, VIRTUOSO II DR/VR ICD D274DRG AND D274VRC.
P980035|S310|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA VERSA, SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|03/20/2013|||OK30|NEW LASER SEAM WELDER EQUIPMENT AT THE MANUFACTURING FACILITY IN TOLOCHENAZ, SWITZERLAND.
P010015|S189|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|03/20/2013|||OK30|IC MANUFACTURE TEST CHANGES FOR THE ADVISA DR IPG A4DR01, ADVISA MRI IPG A2DR01,CONSULTA CRT-P C4TR01, SYNCRA CRT-P C2TR01,  CONCERTO II CRT-D D274TRK, CONSULTA DF4 ICD D204TRM, CONSULTA ICD D224TRK,MAXIMO II CRT-D D264TRM, D284TRK, PROTECTA CRT-D D334TRG, D334TRM, PROTECTA XT CRT-D D314TRG, D314TRM,  MAXIMO II ICD D264DRM, D264VRM, D284DRG, D284VRC, PROTECTA ICDD334DRG, D334DRM, D334VRG, D334VRM, PROTECTA XT ICD D314DRG, D314DRM, D314VRG, D314VRM, SECURA ICD D204DRM, D204VRM, D224DRG, D224VRC, VIRTUOSO II DR/VR ICD D274DRG AND D274VRC.
P010031|S362|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|03/20/2013|||OK30|IC MANUFACTURE TEST CHANGES FOR THE ADVISA DR IPG A4DR01, ADVISA MRI IPG A2DR01,CONSULTA CRT-P C4TR01, SYNCRA CRT-P C2TR01,  CONCERTO II CRT-D D274TRK, CONSULTA DF4 ICD D204TRM, CONSULTA ICD D224TRK,MAXIMO II CRT-D D264TRM, D284TRK, PROTECTA CRT-D D334TRG, D334TRM, PROTECTA XT CRT-D D314TRG, D314TRM,  MAXIMO II ICD D264DRM, D264VRM, D284DRG, D284VRC, PROTECTA ICDD334DRG, D334DRM, D334VRG, D334VRM, PROTECTA XT ICD D314DRG, D314DRM, D314VRG, D314VRM, SECURA ICD D204DRM, D204VRM, D224DRG, D224VRC, VIRTUOSO II DR/VR ICD D274DRG AND D274VRC.
P080027|S010|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|03/19/2013|||OK30|CHANGE TO AN IN-PROCESS TEST METHOD FOR HCV ANTIGENS AND CONJUGATE.
P000040|S029|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/22/2013|08/14/2013|||APPR|APPROVAL FOR UPDATED LABELING TO REFLECT THE RESULTS OF THE GENESYS HTA SYSTEM POST-APPROVAL STUDY PROTOCOL.
P860003|S071|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2013|08/08/2013|||APPR|APPROVAL FOR CHANGES IN TWO MATERIALS USED IN MOLDING COMPONENTS OF THE UVAR® XTS® AND CELLEX® PROCEDURAL KITS.
P040044|S048|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/22/2013|05/17/2013|||APPR|APPROVAL FOR CLARIFICATION AND SIMPLIFICATION OF THE LANGUAGE USED INTHE INSTRUCTION FOR USE AND REMOVAL OF THE STERILIZATION INDICATOR LABEL FROM THE DEVICE POUCH FOR THE MYNX CADENCE VASCULAR CLOSURE DEVICE, 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE, AND 5F MYNXGRIP VASCULAR CLOSURE DEVICE.
P060022|S015|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2013|03/26/2013|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P050038|S015|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT PARTICLES|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2013|03/21/2013|||OK30|PROPOSED INTRODUCTION OF AN ADDITIONAL QUALITY CONTROL STEP FOR THE ARISTA AH ABSORBABLE HEMOSTAT, FLEXITIP APPLICATOR FAMILY.
P980016|S399|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2013|03/20/2013|||OK30|IC MANUFACTURE TEST CHANGES FOR THE ADVISA DR IPG A4DR01, ADVISA MRI IPG A2DR01,CONSULTA CRT-P C4TR01, SYNCRA CRT-P C2TR01,  CONCERTO II CRT-D D274TRK, CONSULTA DF4 ICD D204TRM, CONSULTA ICD D224TRK,MAXIMO II CRT-D D264TRM, D284TRK, PROTECTA CRT-D D334TRG, D334TRM, PROTECTA XT CRT-D D314TRG, D314TRM,  MAXIMO II ICD D264DRM, D264VRM, D284DRG, D284VRC, PROTECTA ICDD334DRG, D334DRM, D334VRG, D334VRM, PROTECTA XT ICD D314DRG, D314DRM, D314VRG, D314VRM, SECURA ICD D204DRM, D204VRM, D224DRG, D224VRC, VIRTUOSO II DR/VR ICD D274DRG AND D274VRC.
P000040|S028|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2013|07/09/2013|||APPR|APPROVAL FOR AN ENERGY DIRECTED WELDING PROCESS FOR THE GENESYS HTA FILTER ASSEMBLY COMPONENTS.
P860004|S188|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2013|03/22/2013|||OK30|USE OF NEW MANUFACTURING SOFTWARE.
P980022|S133|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMPS;PARADIGM REAL-TIME REVEL INSULIN PUMPS|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2013|01/15/2014|||APPR|APPROVAL FOR THE REDUCTION OF KEYPAD BUTTON (DOME) SIZES, NEW KEYPAD OVERLAY SUPPLIER (BERGQUIST), AND KEYPAD/ OVERLAY/ CASE ASSEMBLY PROCESS FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS: MMT-522, MMT-522K, MMT-722, MMT-722K AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS: MMT-523, MMT-523K, MMT-723, AND MMT-723K) THAT ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL SYSTEMS,  RESPECTIVELY.
P100010|S023|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2013|03/21/2013|||OK30|ADDITION OF A NEW HEATING PROCESS AND APPARATUS TO BE USED IN THE THERMAL BONDING AND FORMING OF THE DISTAL TIP SECTIONS OF THE CATHETER SHAFTS.
P060025|S010|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|3F AORTIC BIOPROSTHESIS|LWR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2013|05/29/2013|||APPR|APPROVAL FOR CHANGES TO THE RINSING AND FIXATIONS SOLUTIONS USED INTHE MANUFACTURE OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 3F AORTIC BIOPROSTHESIS, MODEL 1000 AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P110004|S001|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX SYSTEM|MAF|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2013|12/19/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NIRXCELL COCR CORONARY STENT ON RX SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE ASSOCIATED WITH STENOTIC LESIONS IN DE NOVO NATIVE CORONARY ARTERIES (LENGTH ¿30MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50MM TO 4.00MM.
P970051|S106|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2013|03/22/2013|||OK30|INTRODUCTION OF ALTERNATIVE NEW CUTTING LATHES AND CHANGES TO CUTTING PROCESS MONITORING METHOD.
P950020|S061|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|FLEXTOME CORONARY CUTTING BALLOON|NIQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|06/21/2013|||APPR|APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.
P020009|S104|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|06/21/2013|||APPR|APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.
P040016|S110|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|06/21/2013|||APPR|APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.
P060006|S043|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|06/21/2013|||APPR|APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.
P100023|S072|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACILITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|06/21/2013|||APPR|APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.
P950029|S078|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR AND DR, ESPRIT SR AND DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2013|03/26/2013|||OK30|CHANGES TO THE PROCESS LIMITS FOR GASES USED TO FILL FINISHED DEVICES AND ALSO UPDATES TO THE GAS CONCENTRATION LIMITS WITHIN THE INTERNAL ATMOSPHERE FOR THE IMPLANTABLE PULSE GENERATORS.
P110010|S051|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|06/21/2013|||APPR|APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.
P980049|S081|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR AND DR, PARADYM RF VR AND DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2013|03/26/2013|||OK30|CHANGES TO THE PROCESS LIMITS FOR GASES USED TO FILL FINISHED DEVICES AND ALSO UPDATES TO THE GAS CONCENTRATION LIMITS WITHIN THE INTERNAL ATMOSPHERE FOR THE IMPLANTABLE PULSE GENERATORS.
P060027|S049|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D, PARADYM RF CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2013|03/26/2013|||OK30|CHANGES TO THE PROCESS LIMITS FOR GASES USED TO FILL FINISHED DEVICES AND ALSO UPDATES TO THE GAS CONCENTRATION LIMITS WITHIN THE INTERNAL ATMOSPHERE FOR THE IMPLANTABLE PULSE GENERATORS.
P100021|S023|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2013|03/25/2013|||OK30|ADDITIONAL PET RESIN SUPPLIER.
P000058|S053|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2013|03/27/2013|||OK30|ADDITION OF AN ALTERNATE WATER SUPPLIER.
P000054|S038|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2013|03/27/2013|||OK30|ADDITION OF AN ALTERNATE WATER SUPPLIER.
P050053|S030|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2013|03/27/2013|||OK30|ADDITION OF AN ALTERNATE WATER SUPPLIER.
P090013|S084|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2013|03/26/2013|||OK30|IMPLEMENTATION OF AUTOMATED LEAD TESTING EQUIPMENT.
P890003|S269|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2013|05/24/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950, 24951, READER MODEL 24955, AND ACCESSORIES, WHICH SUPPORT THE DEVICES.
P980016|S400|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD, INTRINSIC 30 ICD, INTRINSIC ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO VR IC|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2013|05/24/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950, 24951, READER MODEL 24955, AND ACCESSORIES, WHICH SUPPORT THE DEVICES.
P980035|S311|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND ENPULSE E1 IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2013|05/24/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950, 24951, READER MODEL 24955, AND ACCESSORIES, WHICH SUPPORT THE DEVICES.
P010015|S190|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2013|05/24/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950, 24951, READER MODEL 24955, AND ACCESSORIES, WHICH SUPPORT THE DEVICES.
P010031|S363|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INSYNC II P ROTECT ICD, INSYNC III MARQUIS ICD, INSYNC MARQUIS ICD, INSYNC MAXIMO ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2013|05/24/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950, 24951, READER MODEL 24955, AND ACCESSORIES, WHICH SUPPORT THE DEVICES.
P090013|S085|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2013|05/24/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950, 24951, READER MODEL 24955, AND ACCESSORIES, WHICH SUPPORT THE DEVICES.
P990074|S025|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|SALINE FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2013|03/27/2013|||OK30|CHANGE THE CURRENT SOAKING METHOD FROM A MANUAL TO AN AUTOMATIC PROCESS DURING THE MANUFACTURING PROCESS.
P100047|S017|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2013|03/27/2013|||OK30|ADDITION OF A NEW COATING CHAMBER.
P020056|S019|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SILICONE-FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2013|03/27/2013|||OK30|CHANGE THE CURRENT SOAKING METHOD FROM A MANUAL TO AN AUTOMATIC PROCESS DURING THE MANUFACTURING PROCESS.
P040046|S001|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE -FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2013|03/27/2013|||OK30|CHANGE THE CURRENT SOAKING METHOD FROM A MANUAL TO AN AUTOMATIC PROCESS DURING THE MANUFACTURING PROCESS.
P060040|S025|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2013|04/01/2013|||OK30|ADDITION OF A NEW STERILIZATION CHAMBER.
P870072|S052|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2013|04/01/2013|||OK30|ADDITION OF A NEW STERILIZATION CHAMBER.
P000025|S068|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COMBI 40+ COHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2013|05/16/2013|||APPR|APPROVAL FOR THE REUSABLE MI1000 PIN DRILL GUIDE WHICH ASSISTS IN THE SURGICAL IMPLANTATION OF THE APPROVED MI1000 CONCERT PIN IMPLANT.
P060033|S073|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2013|03/27/2013|||OK30|CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM
P110013|S008|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|03/01/2013|03/27/2013|||OK30|CHANGE TO AUTOMATE THE INFORMATION MANAGEMENT SYSTEM
P100017|S005|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REAL TIME HCV|MZP|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/01/2013|09/25/2013|||APPR|APPROVAL FOR THE ADDITION OF AN OPTIONAL EXTENDED USE FEATURE TO ALLOW PREPARED AMPLIFICATION MASTER MIX AND INTERNAL CONTROL TO BE USED A SECOND TIME WITHIN 14 DAYS OF INITIAL USE IF STORED AT -25°C TO -15°C; 2) PROCESS IMPROVEMENTS TO THE LIQUID LEVEL SENSING PERFORMED BY THE ABBOTT M2000SP INSTRUMENT; 3) THE CONVERSION OF MANUAL PLATE FILLING TO AUTOMATED PLATE FILLING; AND 4) ASSOCIATED SOFTWARE REVISIONS.
P990046|S031|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2013|03/29/2013|||OK30|ADDITION OF A NEW CLEAN ROOM FOR SEWING CUFF SUB-ASSEMBLY COMPONENT.
P010015|S191|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|03/20/2013|||OK30|ADDITION OF A BATTERY BURN-IN PROCESS TO THE UNIVERSAL BURN-IN TEST SYSTEM PROCESSING AND INSPECTION METHODS AND ASSOCIATED SOFTWARE.
P120005|S003|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLANTINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|03/26/2013|||OK30|ADDITION OF A LASER MARKING MACHINE USED TO MARK THE G4 TRANSMITTER.
P080012|S013|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMERA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/2013|06/03/2013|||APPR|APPROVAL FOR ADDING AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE SUTURE WINGS (STRAIGHT AND 90 DEGREE) THAT ARE SUPPLIED IN THE CATHETER KIT.
P100047|S018|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|04/02/2013|||OK30|CONDUCT LAL PYROGEN TESTING ON COMPONENTS OF THE LEFT VENTRICULAR ASSIST DEVICE OBTAINED FROM PRE-STERILE ASSEMBLY LOTS.
P980016|S401|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPACE DATA COLLECTOR AND NIKON ROUTER|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|03/28/2013|||OK30|NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.
P010015|S192|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P,SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|03/28/2013|||OK30|NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.
P010031|S364|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-P,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|03/28/2013|||OK30|NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.
P090013|S086|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|03/28/2013|||OK30|NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.
P980035|S312|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|03/28/2013|||OK30|NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.
P990081|S016|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2 (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|04/02/2013|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER FOR SUBASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS, CRITICAL COMPONENTSUSED IN THE MANUFACTURE OF THE SUBJECT REAGENTS.
P100027|S006|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|04/02/2013|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER FOR SUBASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS, CRITICAL COMPONENTSUSED IN THE MANUFACTURE OF THE SUBJECT REAGENTS.
P020055|S006|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|04/02/2013|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER FOR SUBASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS, CRITICAL COMPONENTSUSED IN THE MANUFACTURE OF THE SUBJECT REAGENTS.
P920047|S056|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER PRIME HTD|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|04/01/2013|||OK30|IMPLEMENTATION OF ADDITIONAL DATA STORAGE IN AN ELECTRONIC MANUFACTURING TRACEABILITY SYSTEM, INCREASE IN IN-PROCESS INSPECTION FREQUENCY, AND ELIMINATION OF AN INSPECTION STEP AT BATCH SETUP.
P020025|S039|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP CARDIAC ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|04/01/2013|||OK30|IMPLEMENTATION OF ADDITIONAL DATA STORAGE IN AN ELECTRONIC MANUFACTURING TRACEABILITY SYSTEM, INCREASE IN IN-PROCESS INSPECTION FREQUENCY, AND ELIMINATION OF AN INSPECTION STEP AT BATCH SETUP.
P030017|S157|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/2013|05/30/2013|||APPR|APPROVAL FOR AN UPDATING TO THE CLINICIAN PROGRAMMER COMPUTER USED WITH THE PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS. A TABLET COMPUTER FROM ASUS, MODEL EEE SLATE B121, WILL BE USED TO REPLACE THE CURRENT CLINICIAN PROGRAMMER, A TOSHIBA MODEL M400 LAPTOP COMPUTER. THE ASUS TABLET IS AN OFF-THE-SHELF COMPUTER, CUSTOMIZED TO BE A CLINICIANS PROGRAMMER BY INSTALLING THE EEE SLATE B121 BOOT AND IMAGE SOFTWARE AND CONFIGURING THE SYSTEM WITH THE BN1.2 AND BN3 BIONICNAVIGATOR SOFTWARE.
P030050|S015|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AESTHETIC|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2013|08/15/2013|||APPR|APPROVAL FOR REQUALIFICATION OF THE CONTRACT STERILIZER OF RECORD; ADDITION OF AN ALTERNATIVE STERILIZATION SITE, AND REPLACEMENT OF THE GAMMA RADIATION SOURCE FOR THE STERILITY EQUIPMENT.
P100012|S004|NUVASIVE, INC.|7475 LUSK BLVD||SAN DIEGO|CA|92121||PROSTHESIS, INTERVERTEBRAL DISC|NUVASIVE PCM CERVICAL DISC|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/04/2013|05/03/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040021|S023|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR/EPIC VALVE|LWR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2013|06/03/2013|||APPR|APPROVAL FOR A CHANGE TO THE VALVE HOLDER FORCE SPECIFICATION.
P000008|S030|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2013|03/27/2013|||OK30|AGENCY TO ACCEPT A CHANGE IN THE LAP-BAND STERILIZATION VALIDATION METHOD.
P980035|S313|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2013|03/26/2013|||OK30|CHANGE TO THE DESCUM AND CLEANING PROCESSES FOR THE 3ÌM CMOS INTEGRATED CIRCUIT.
P010015|S193|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2013|03/26/2013|||OK30|CHANGE TO THE DESCUM AND CLEANING PROCESSES FOR THE 3ÌM CMOS INTEGRATED CIRCUIT.
P010031|S365|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCENTOIICRT-D, CONSULTA ICD,MAXIMOII CRT,PROTECTA CRT-D, PROTECAXT CRT-D,VIVA S CRT-D,VIVAXT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2013|03/26/2013|||OK30|CHANGE TO THE DESCUM AND CLEANING PROCESSES FOR THE 3ÌM CMOS INTEGRATED CIRCUIT.
P100044|S008|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|INTERSECTENT PROPEL MINI SINUS IMPLANT|OWO|EN|Normal 180 Day Track No User Fee|Other Report|N|03/04/2013|07/17/2013|||APPR|AGREED TO THE RECOMMENDATION TO REVISE THE STABILITY PROTOCOL TO REFLECT THE DRUG RELEASE ACCEPTANCE CRITERIA OF ± 12% OF THE TARGET VALUE USED FOR PRODUCT RELEASE.
P090013|S087|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2013|03/26/2013|||OK30|CHANGE TO THE DESCUM AND CLEANING PROCESSES FOR THE 3ÌM CMOS INTEGRATED CIRCUIT.
P060025|S011|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|3F AORTIC BIOPROSTHESIS|LWR|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/05/2013|04/02/2013|||APPR|APPROVAL FOR REVISIONS TO THE LABELING REGARDING THE IMPLANTATION TECHNIQUE FOR THE BIOPROSTHESIS.
P980016|S402|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMOII ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2013|03/26/2013|||OK30|CHANGE TO THE DESCUM AND CLEANING PROCESSES FOR THE 3ÌM CMOS INTEGRATED CIRCUIT.
P010047|S028|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/07/2013|11/08/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860003|S072|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2013|03/20/2013|||OK30|SUPPLIER CHANGE FOR ONE OF THE CELLEX SYSTEM COMPONENTS.
P890047|S040|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|VISCOAT, DUROVISC AND DISCOVISC DEVICES OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2013|04/04/2013|||OK30|USE ONE GENERIC ¿WORST CASE¿ TEST BIOLOGICAL INDICATOR (BI) BLISTER AS AN ALTERNATIVE TO THE PRODUCT-SPECIFIC BI BLISTER FOR USE DURING ETO STERILIZATION.
P840064|S053|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2013|04/04/2013|||OK30|USE ONE GENERIC ¿WORST CASE¿ TEST BIOLOGICAL INDICATOR (BI) BLISTER AS AN ALTERNATIVE TO THE PRODUCT-SPECIFIC BI BLISTER FOR USE DURING ETO STERILIZATION.
P050038|S016|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2013|04/05/2013|||OK30|REMOVAL OF THE SHRINK WRAP FROM THE OUTER SHELF BOX CARTONS.
P080025|S049|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR BOWEL CONTROL|EZW|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/07/2013|04/15/2014|||APPR|APPROVAL FOR LABELING UPDATES TO INCORPORATE THE LONG-TERM DATA FROM THE FECAL INCONTINENCE POST-APPROVAL STUDY INTO THE INTERSTIM® THERAPY LABELING.
P010047|S027|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2013|08/08/2013|||APPR|APPROVAL FOR A MODIFIED KIT ORIENTATION DURING E-BEAM STERILIZATION.
P970004|S153|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/07/2013|04/15/2014|||APPR|APPROVAL FOR LABELING UPDATES TO INCORPORATE THE LONG-TERM DATA FROM THE FECAL INCONTINENCE POST-APPROVAL STUDY INTO THE INTERSTIM THERAPY LABELING.
P110006|S001|U-SYSTEMS, INC.|9900 WEST INNOVATIVE DRIVE|MAIL STOP RP2138|WAUWATOSA|WI|53226||Automated breast ultrasound|SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM|PAA|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2013|06/17/2013|||APPR|APPROVAL FOR A NEW TRANSDUCER, NEW PRE-SET COMPRESSION ASSIST FUNCTION, AND OTHER SOFTWARE AND COMPUTER HARDWARE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INVENIA ABUS AND IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREASTCANCER SCREENING IN ASYMPTOMATIC WOMAN FOR WHOM SCREENING MAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BIRADSCOMPOSITION/DENSITY 3 OR 4), AND HAVE NOT HAD PREVIOUS CLINICAL BREAST INTERVENTION. THE DEVICE IS INTENDED TO INCREASE BREAST CANCER DETECTION IN THE DESCRIBED PATIENT POPULATION.
P000054|S039|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/07/2013|05/31/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF STUDY 400.
P110016|S007|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/07/2013|08/29/2013|||APPR|APPROVAL FOR THE SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED, IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR AND VERISENSE SYSTEM. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND THE1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETERS ARE INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
P980016|S403|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMOII ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSOII DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2013|04/04/2013|||OK30|ADDITION OF AN ADDITIONAL ASSEMBLY LINE WORK CELL.
P010031|S366|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTOII CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2013|04/04/2013|||OK30|ADDITION OF AN ADDITIONAL ASSEMBLY LINE WORK CELL.
P090022|S016|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|ENDOTOXIN TEST METHOD|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2013|04/05/2013|||OK30|REQUESTED THE USE OF A DIFFERENT ENDOTOXIN TEST METHOD.
P020041|S003|FEMCAP, INC.|14058 MIRA MONTANA DR.||DEL MAR|CA|92014|3455|CAP, CERVICAL, CONTRACEPTIVE|FEMCAP|LLQ|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2013|08/21/2013|||APPR|APPROVAL FOR KDL PRECISION MOLDING CORPORATION, A MANUFACTURING SITE LOCATED IN PACOIMA, CALIFORNIA
P980035|S314|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG,ADVISA DRIPG,ADVISA MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/04/2013|||OK30|CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF DEVICE COMPONENTS.
P010031|S367|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAX||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/04/2013|||OK30|CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF DEVICE COMPONENTS.
P010015|S194|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P,SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/04/2013|||OK30|CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF DEVICE COMPONENTS.
P980016|S404|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/04/2013|||OK30|CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF DEVICE COMPONENTS.
P090013|S088|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/04/2013|||OK30|CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF DEVICE COMPONENTS.
P990001|S110|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/04/2013|||OK30|CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF DEVICE COMPONENTS.
P090006|S009|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|01/22/2014|||APPR|APPROVAL FOR MULTIPLE STENT PROCESSING CHANGES FOR THE COMPLETE SE VASCULAR STENT SYSTEM.
P010032|S070|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS NEUROSTIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/10/2013|||OK30|MANUFACTURING CHANGE FOR PERCUTANEOUS LEADS AND TERMINAL END LEADS.
P120005|S004|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/11/2013|||OK30|MANUFACTURING PROCESS CHANGE TO THE AUTOMATED FLUIDICS DIPPER SENSOR FOR THE RESISTANCE MEMBRANE LAYER OF THE G4 PLATINUM SENSOR.
P970003|S159|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|PULSE AND PULSE DUO GENERATORS, DEMIPULSE AND DEMIPULSE DUO GENERATORS, ASPIREHC MODEL 105 GENERATOR|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/03/2013|||OK30|ADDITION OF STORAGE/PROCESSING REQUIREMENTS FOR CERTAIN COMPONENTS.
P110035|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2013|04/10/2013|||OK30|IMPLEMENT THE USE OF A FIXTURE IN THE MANUFACTURING PROCESS TO SET THE STENT MATERIAL PROPERTIES AND ALIGN THE STENT STRUTS PRIOR TO INSPECTION.
P830055|S132|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2013|08/06/2013|||APPR|APPROVAL FOR CHANGES TO THE PROCESS PARAMETERS FOR AN EXISTING PACKAGE SEALER AND ADDITION OF AN ALTERNATE PACKAGE SEALER.
P070026|S012|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX TOTAL HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2013|08/06/2013|||APPR|APPROVAL FOR CHANGES TO THE PROCESS PARAMETERS FOR AN EXISTING PACKAGE SEALER AND ADDITION OF AN ALTERNATE PACKAGE SEALER.
P090002|S009|DEPUY ORTHOPAEDICS, INC.|P.O BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, hip, semi-constrained, ceramic-on-metal articulation|PINNACLE COMPLETE ACETABULAR HIP SYSTEM|OVO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2013|08/06/2013|||APPR|APPROVAL FOR CHANGES TO THE PROCESS PARAMETERS FOR AN EXISTING PACKAGE SEALER AND ADDITION OF AN ALTERNATE PACKAGE SEALER.
P080012|S014|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2013|04/09/2013|||OK30|ADDITION OF AN ALTERNATE SUB-TIER SUPPLIER FOR A COMPONENT OF THE PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM.
P990081|S017|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2013|07/23/2013|||APPR|APPROVAL FOR MODIFICATIONS IN DESIGN TO PREVENT WASTE SYSTEM OVERFLOW OR OTHER LEAKS FROM CAUSING SHORTING CONDITIONS WITH THE BENCHMARK ULTRAS INTERNAL CIRCUITS.
P100027|S007|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|03/12/2013|07/23/2013|||APPR|APPROVAL FOR MODIFICATIONS IN DESIGN TO PREVENT WASTE SYSTEM OVERFLOW OR OTHER LEAKS FROM CAUSING SHORTING CONDITIONS WITH THE BENCHMARK ULTRAS INTERNAL CIRCUITS.
P980035|S315|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA MRI (A2DR01)|NVZ|CV|30-Day Notice||N|03/13/2013|03/28/2013|||OK30|ELIMINATION OF THE INCOMING INSPECTION OF A BATTERY COMPONENT AT AN INTERNAL SUPPLIER LOCATION; REDUCTION IN PRODUCTION BURN-IN TIME; AND AN UPDATE TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS AND ASSOCIATED SOFTWARE.
P100018|S006|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPLINE TM EMBOLIZATION DEVICE|OUT|NE|30-Day Notice||N|03/12/2013|04/02/2013|||OK30|CHANGE THE SOFTWARE USED TO GENERATE PRINTED WORK ORDERS.
P030016|S025|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|COLLAMER VISIAN IMPLANTABLE COLLAMER LENS MICL|MTA|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2013|08/22/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STAAR SURGICAL COMPANY IN MONROVIA, CALIFORNIA.
P830061|S086|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/13/2013|02/18/2014|||APPR|APPROVAL FOR REMOVAL OF THE DEXAMETHASONE SODIUM PHOSPHATE (DSP) COATING FROM THE LEAD TIP AND THE MANUFACTURING SITE CHANGE FOR THE MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) FOR THE CAPSURE SENSE FAMILY OF LEADS.
P020011|S007|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY|MZP|MI|30-Day Notice||N|03/13/2013|04/08/2013|||OK30|CHANGE FOR MODIFICATION OF A QUALITY CONTROL (QC) PANEL MEMBER WHICH WILL BE USED IN RELEASE TESTING OF THE FINAL APPROVED DEVICE.
P970003|S160|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2013|04/12/2013|||OK30|THE ADDITION OF A QUALITY INSPECTION STEP FOR POWER ADAPTER CABLES.
P030009|S063|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/14/2013|04/12/2013|||APPR|APPROVAL FOR AN UPDATE TO THE PRODUCT LABELING TO ADD THE ACRONYM 'BMS' TO THE INTEGRITY PRODUCT AND 'DES' TO THE RESOLUTE INTEGRITY PRODUCT TO THE DEVICE'S LUER.
P110013|S009|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Special (Immediate Track)||N|03/14/2013|04/12/2013|||APPR|APPROVAL FOR AN UPDATE TO THE PRODUCT LABELING TO ADD THE ACRONYM 'BMS' TO THE INTEGRITY PRODUCT AND 'DES' TO THE RESOLUTE INTEGRITY PRODUCT TO THE DEVICE'S LUER.
P040043|S051|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Panel Track|Change Design/Components/Specifications/Material|N|03/14/2013|09/10/2013|13M-1323|10/24/2013|APPR|APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THIS DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA, INCLUDING:1)  ISOLATED LESIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM; AND C) > 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.2) TYPE B DISSECTIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) > 20 MM LANDING ZONE PROXIMAL TO THE PRIMARY ENTRY TEAR; PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED; ANDC) DIAMETER AT PROXIMAL EXTENT OF PROXIMAL LANDING ZONE IN THE RANGE OF 16-42 MM.
P830055|S133|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2013|04/12/2013|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP AFTER THE IN PROCESS CLEAN (IPC). THE INSPECTION WILL ENSURE THAT THERE WILL BE NO REMAINING POLISHING AGENTS LEFT ON THE ATTUNE CR AND ATTUNE PS FEMORAL COMPONENTS AFTER THE IPC STEP IS PERFORMED. THE ATTUNE CR AND ATTUNE PS FEMORAL COMPONENTS WERE PREVIOUSLY APPROVED AS COMPATIBLE COMPONENTS TO THE CLASS III ROTATING PLATFORM ATTUNE TIBIAL COMPONENTS.
P030054|S244|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, PROMOTE+. PROMOTE RF, PROMOTE ACCEL, UNIFY, QUICKSITE, QUICKFLEX,|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2013|04/11/2013|||OK30|AN ALTERNATE SUPPLIER FOR MERLIN PCS ACCESSORIES.
P080032|S013|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2013|06/03/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION IN QUINCY, MASSACHUSETTS.
P030017|S158|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2013|04/16/2013|||OK30|CHANGE THE STYLET HANDLE.
P110007|S002|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2013|04/09/2013|||OK30|CHANGE TO THE IN-PROCESS BIOBURDEN TESTING.
P810031|S047|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD) HEALON,HEALON GV, AND HEALON5 PRODUCTS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2013|04/09/2013|||OK30|CHANGE TO THE IN-PROCESS BIOBURDEN TESTING.
P860004|S189|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEMS|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2013|09/09/2015|||APPR|APPROVAL FOR CHANGES IN MANUFACTURING AND REQUIREMENTS FOR THE PUMP TUBEASSEMBLY
P860057|S106|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2013|04/16/2013|||OK30|ADDITION OF A TERMINAL LIQUID STERILIZATION OVEN.
P110042|S006|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|04/11/2013|||OK30|USE AMBIENT CONDITIONS FOR ALL CURING STEPS IN PG MANUFACTURING.
P840001|S237|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREPRIME NEUROSTIMULATOR, PRIMEADVANCED NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEUROSTIMULATOR FOR SPINAL CORD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|04/17/2013|||OK30|CHANGE IN TEST SAMPLE SIZE FOR CERTAIN CONNECTOR COMPONENTS PROVIDED BY THE SUPPLIER.
P030017|S159|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|04/17/2013|||OK30|ALLOW MODIFICATIONS TO THE STERILIZATION EQUIPMENT AND ASSOCIATED STERILIZATION CYCLE FOR THE DEVICES.
P860004|S190|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|04/17/2013|||OK30|CHANGE IN TEST SAMPLE SIZE FOR CERTAIN CONNECTOR COMPONENTS PROVIDED BY THE SUPPLIER.
P960009|S168|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA RC NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|04/17/2013|||OK30|CHANGE IN TEST SAMPLE SIZE FOR CERTAIN CONNECTOR COMPONENTS PROVIDED BY THE SUPPLIER.
P970004|S154|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|04/17/2013|||OK30|CHANGE IN TEST SAMPLE SIZE FOR CERTAIN CONNECTOR COMPONENTS PROVIDED BY THE SUPPLIER.
P080025|S050|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|04/17/2013|||OK30|CHANGE IN TEST SAMPLE SIZE FOR CERTAIN CONNECTOR COMPONENTS PROVIDED BY THE SUPPLIER.
P960009|S169|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM|MHY|NE|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/18/2013|06/22/2015|||APPR|APPROVAL FOR A LABELING UPDATE THAT MODIFIES YOUR DEEP BRAIN STIMULATION (DBS) THERAPY INFORMATION FOR PRESCRIBER¿S AND THE DBS PATIENT THERAPY GUIDE. THE LABELING UPDATE IS TO MODIFY TWO PRECAUTIONS THAT APPEAR IN EACH MANUAL:1) REMOVE THE PRECAUTION ON POTENTIAL RELEASE OF NEUROTOXIC AND CARCINOGENIC COMPOUNDS FROM POLYURETHANE LEAD MATERIALS; AND2) MODIFY THE PRECAUTION ON LONG-TERM SAFETY OF MULTIPLE LEADS AND REPLACEMENT LEADS TO READ: THE LONG-TERM SAFETY ASSOCIATED WITH IMPLANTING MORE THAN ONE LEAD ON THE SAME SIDE OF THE BRAIN IS UNKNOWN.
P940035|S009|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|NMP22 BLADDERCHEK TEST|NAH|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|04/02/2013|||OK30|INCREASE THE MANUFACTURING EFFICIENCY OF THE ASSEMBLED CASSETTE BY MODIFYING THE ASSEMBLY METHOD USED IN THE MANUFACTURE OF NMP22 BLADDERCHEK FROM ASSEMBLED AND POUCHED MANUALLY BY HAND BY OPERATORS, TO BE ASSEMBLED BY VALIDATED AUTOMATED EQUIPMENT.
P050027|S005|KARL STORZ ENDOSCOPY-AMERICA, INC.|2151 E. GRAND AVE.||EL SEGUNDO|CA|90245||Light source system, diagnostic endoscopic|KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM|OAY|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2013|09/23/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT KARL STORZ GMBH & CO., IN  TUTTLINGEN, GERMANY TO MANUFACTURE THE C LIGHT SOURCE.
P960006|S038|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2013|05/07/2013|||APPR|APPROVAL FOR AN ALTERNATE PRIMER MATERIAL FOR THE FLEXTEND AND ACTIVE FIXATION RELIANCE IS-1/4-SITE LEADS.
P910073|S116|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE IS-1/DF-1 LEAD AND  RELIANCE 4-SITE LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2013|05/07/2013|||APPR|APPROVAL FOR AN ALTERNATE PRIMER MATERIAL FOR THE FLEXTEND AND ACTIVE FIXATION RELIANCE IS-1/4-SITE LEADS.
P100049|S005|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2013|04/17/2013|||OK30|UPDATE IN MANUFACTURING PROCESS.
P020018|S048|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/18/2013|05/09/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110012|S003|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES|OWE|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2013|04/17/2013|||OK30|THREE MANUFACTURING CHANGES, INCLUDING THE ADDITION OF A WORKING CELL BANK, IMPLEMENTATION OF A PRE-FERMENTATION OPTICAL DENSITY READING, AND MODIFICATION TO PROPAGATING THE CELL LINE USED TO MAKE NEGATIVE CONTROL SLIDES.
P040020|S046|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice||N|03/20/2013|04/17/2013|||OK30|AN ALTERNATE EO STERILIZATION VENDOR.
P930014|S067|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice||N|03/20/2013|04/17/2013|||OK30|AN ALTERNATE EO STERILIZATION VENDOR.
P010012|S324|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, AND PUNCTUA MODELS OF CRT¿S|LWP|CV|30-Day Notice||N|03/20/2013|04/19/2013|||OK30|ALTERNATE SUPPLIERS FOR MOSFET AND MOSIGT TRANSISTORS.
P100021|S024|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT II STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2013|05/03/2013|||APPR|APPROVAL FOR A STERILIZATION SITE LOCATED AT SYNERGY HEALTH STERILIZATION UK LTD IN DAVENTRY, UNITED KINGDOM, NN11 8RB.
P960040|S289|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, AND PUNCTUA MODELS OF ICD¿S|LWP|CV|30-Day Notice||N|03/20/2013|04/19/2013|||OK30|ALTERNATE SUPPLIERS FOR MOSFET AND MOSIGT TRANSISTORS.
P030017|S160|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice||N|03/20/2013|04/12/2013|||OK30|ALTERNATE WELDER FOR A MANUFACTURING PROCESS.
P080006|S050|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P830061|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD, CAPSURE SENSE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P850089|S093|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD|NVY|CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P920015|S105|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|6947M SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P930039|S083|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P980016|S405|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD|LWS|CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P010031|S368|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P030036|S054|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|3830 SELECTSECURE LEAD|NVY|CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P060039|S042|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice||N|03/20/2013|04/18/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P950005|S042|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS CATHETER, CELSIUS RMT CATHETER, EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|07/22/2013|||APPR|APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.
P990025|S035|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR CATHETER, NAVISTAR RMT CATHETER, EZ STEER NAY CATHETER, BIOSENSE WEBSTER CABLES|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|07/22/2013|||APPR|APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.
P010068|S032|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS|OAD|CV|135 Review Track For 30-Day Notice||N|03/21/2013|07/22/2013|||APPR|APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.
P030031|S050|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|07/22/2013|||APPR|APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.
P040036|S033|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER, NAVISTAR RMT THERMOCOOL CATHETER, EZ STEER|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|07/22/2013|||APPR|APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.
P930031|S042|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice||N|03/21/2013|04/18/2013|||OK30|ELIMINATE AN IN-PROCESS VERIFICATION ACTIVITY.
P940019|S036|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT (ILIAC) ENDOPROSTHESIS|NIO|CV|30-Day Notice||N|03/21/2013|04/18/2013|||OK30|ELIMINATE AN IN-PROCESS VERIFICATION ACTIVITY.
P980033|S031|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|04/18/2013|||OK30|ELIMINATE AN IN-PROCESS VERIFICATION ACTIVITY.
P110035|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|04/18/2013|||OK30|ELIMINATE AN IN-PROCESS VERIFICATION ACTIVITY.
P920015|S106|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MODEL 5019 HV SPLITTER/ADAPTOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|04/12/2013|||OK30|IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNALSUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS;2) AN ADDITIONAL SUPPLIER FOR EXTRUDED TUBING;TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS;3) MODIFICATIONS TO A CONTROLLED ENVIRONMENT; AND4)AN ALTERNATE SUPPLIER OF A SILICONE COMPONENT.
P020025|S040|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZERII TEMPERATURE ABLATION CATHETER, BLAZERII XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATION|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|04/18/2013|||OK30|INTRODUCE AND ALLOW THE USE OF A NEW TEST FIXTURE FOR THE OUT-OF-PLANE INSPECTION.
P030022|S024|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM (RCHS)|MRA|OR|135 Review Track For 30-Day Notice||N|03/21/2013|08/06/2013|||APPR|APPROVAL FOR A SOFTWARE CHANGE TO ANALYZE THE STIKTITE POROUS COATINGS.
P810025|S033|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|04/24/2013|||OK30|ADD AN ALTERNATE SITE FOR ITS WORKING CELL BANK MANUFACTURER, ADD AN ALTERNATE VITAMIN SUPPLIER AND CHANGE SOURCED CHEMICALS TO USP GRADE.
P920047|S057|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|04/18/2013|||OK30|INTRODUCE AND ALLOW THE USE OF A NEW TEST FIXTURE FOR THE OUT-OF-PLANE INSPECTION.
P100005|S002|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|M-VU ALGORITHM ENGINE|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/21/2013|06/19/2013|||APPR|APPROVAL OF M-VU ALGORITHM ENGINE VERSION 2.1.2.0 FOR USE WITH THE FUJIFCRM COMPUTED RADIOGRAPHY (CR) FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM.
P960009|S170|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION (DBS) LEAD CAP|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2013|06/03/2013|||APPR|APPROVAL FOR THE IMPLEMENTATION OF MANUFACTURING PROCESS CHANGES, AND ADDITIONAL INSPECTIONAL STEPS, FOR THE DEVICE.
P040037|S046|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice||N|03/21/2013|04/18/2013|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE TRANSITION COMPONENT OF THE ¿V3.18¿ CATHETER DELIVERY SYSTEM.
P010015|S195|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P030036|S055|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT, SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P060039|S043|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P080006|S051|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P090013|S089|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P830061|S088|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P850089|S094|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, EXCELLENCE SS+ LEAD, IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P890003|S271|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD, SERVICE KIT-PACEMAKER REPAIR KIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P900061|S119|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|END CAP, SIZING SLEEVE, UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P920015|S107|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P930029|S039|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONDUCTR 5 MM (7FR, 8FR TIP), RF CONDUCTR 4 MM (7FR), RF CONTACTR 5 MM (7FR, 8FR TIP), RF CONTACTR 5 MM (7FR, 8FR TIP|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P930039|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, APSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P950024|S047|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
P980050|S080|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/11/2013|||OK30|AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES.
N12159|S031|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FAMILY OF ABSORBABLE HEMOSTATS|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2013|04/23/2013|||OK30|INTRODUCTION OF NEW CUTTING EQUIPMENT.
P920047|S058|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|07/22/2013|||APPR|APPROVAL TO MOVE THE EXTRUSION PROCESS FOR BLAZER PRIME ABLATIONCATHETERS TO A NEW MANUFACTURING LINE INTRODUCING AN AUTOMATED PROCESS TO IDENTIFY AND CUTMARKED SECTIONS OF THE EXTRUDED SHAFT.
P860057|S107|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/24/2013|||OK30|ADDITIONAL SUPPLIER FOR THE PACKAGING JARS.
P030050|S016|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AESTHETIC|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/25/2013|04/23/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060037|S021|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|08/11/2014|||APPR|APPROVAL FOR ELIMINATION OF AN INCREMENTAL RE-VERIFICATION STEP.
P990009|S035|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/2013|09/19/2013|||APPR|APROVAL TO CHANGE THE WARNING STATEMENT `THE SAFETY AND EFFECTIVENESS HAS NOT BEEN ESTABLISHED IN CHILDREN UNDER 2 YEARS OF AGE AND PREGNANT WOMEN¿.
P020018|S049|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2013|04/24/2013|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING AND QUALITY CONTROL PROCEDURES TO PROVIDE ADDITIONAL INSPECTION STEPS REGARDING THE PROXIMAL BARB ALIGNMENT WITH THE TOP CAP SIDE HOLE AND BARB SOLDERING SPECIFICATION FOR THE DEVICE.
P100041|S023|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/24/2013|||OK30|ADDITIONAL SUPPLIER FOR THE PACKAGING JARS.
P000007|S040|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/24/2013|||OK30|ADDITIONAL SUPPLIER FOR THE PACKAGING JARS.
P010041|S042|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/24/2013|||OK30|ADDITIONAL SUPPLIER FOR THE PACKAGING JARS.
P870056|S058|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|PORCINE AORTIC BIOPROTHESIS AND PORCINE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/24/2013|||OK30|ADDITIONAL SUPPLIER FOR THE PACKAGING JARS.
P040016|S113|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|09/05/2013|||APPR|APPROVAL FOR USE OF A SEMI-AUTOMATED POINT-N-CLICK SYSTEM FOR THE DISTAL WELD INSPECTION.
P110021|S009|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/24/2013|||OK30|ADDITIONAL SUPPLIER FOR THE PACKAGING JARS.
P870077|S053|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/24/2013|||OK30|ADDITIONAL SUPPLIER FOR THE PACKAGING JARS.
P020009|S107|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|09/05/2013|||APPR|APPROVAL FOR USE OF A SEMI-AUTOMATED POINT-N-CLICK SYSTEM FOR THE DISTAL WELD INSPECTION.
P050037|S036|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/23/2013|||OK30|ELIMINATION OF BI STERILITY MONITORING FOR THE 3.0 CC RADIESSE INJECTABLE IMPLANT.
P050052|S039|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2013|04/23/2013|||OK30|ELIMINATION OF BI STERILITY MONITORING FOR THE 3.0 CC RADIESSE INJECTABLE IMPLANT.
P080013|S008|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/25/2013|02/06/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110035|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2013|06/06/2013|||APPR|APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.
P960004|S059|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/27/2013|10/08/2015|||APPR|APPROVAL FOR THE FOLLOWING:1) A STERILIZATION PROCESS CHANGE FROM OXYFUME TO 100% ETHYLENE OXIDE;2) DRUG SPECIFICATION CHANGES; 3) LABELING CHANGES; 4) TO FINISH REMAINING 3 MONTHS OF LOT RELEASE STUDY FOR PASSIVE FIXATION LEADS AS NON-CLINICAL POST APPROVAL STUDY;4) MANUFACTURING CHANGES TO REDUCE ELUTION VARIATION;5) TO UPDATE ACTIVE FIXATION BATCH RELEASE STUDY PROTOCOL TO IMPLEMENT NEW MANUFACTURING CHANGES; AND6) TO COMPLETE 12 MONTH LOT RELEASE STUDY AS NON-CLINICAL POST APPROVAL STUDY.
P980035|S316|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG,ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/11/2013|||OK30|REDUCTION OF THE HYBRID BURN-IN TIME FOR THE ADVISA DR,  ADVISA DR MRI IPGS, REVO MRI IPG, CONSULTA AND SYNCRA CRT-PS.
P040036|S035|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/25/2013|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD AND TO ESTABLISH MINIMUMSPECIFICATIONS FOR CHAMBER PARAMETERS FOR TWO OF THE CHAMBERS USED.
P950005|S043|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELCIUS CATHETER,CELCIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER,DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,B|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/25/2013|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD AND TO ESTABLISH MINIMUMSPECIFICATIONS FOR CHAMBER PARAMETERS FOR TWO OF THE CHAMBERS USED.
P990025|S036|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/25/2013|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD AND TO ESTABLISH MINIMUMSPECIFICATIONS FOR CHAMBER PARAMETERS FOR TWO OF THE CHAMBERS USED.
P990071|S022|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|BIOSENSE WEBSTER CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/25/2013|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD AND TO ESTABLISH MINIMUMSPECIFICATIONS FOR CHAMBER PARAMETERS FOR TWO OF THE CHAMBERS USED.
P010015|S196|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P,  SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/11/2013|||OK30|REDUCTION OF THE HYBRID BURN-IN TIME FOR THE ADVISA DR,  ADVISA DR MRI IPGS, REVO MRI IPG, CONSULTA AND SYNCRA CRT-PS.
P060040|S026|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/27/2013|06/03/2013|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO THE 14 VOLT BATTERY CLIP LEMO CONNECTOR HOUSING.
P010068|S033|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELCIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAV DS CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/25/2013|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD AND TO ESTABLISH MINIMUMSPECIFICATIONS FOR CHAMBER PARAMETERS FOR TWO OF THE CHAMBERS USED.
P010014|S042|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/25/2013|||APPR|APPROVAL TO AMEND THE IN-PROCESS INSPECTION CRITERIA USED AT THE WARSAW, INDIANA SITE, TO INCLUDE ADDITIONAL DIMENSIONAL CHECKS AFTER THE POLISHING STEP FOR THE OXFORD® TIBIAL TRAY, TO ALIGN WITH THE WARSAW FACILITY¿S STANDARD PRACTICES.
P030031|S051|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELCIUS THERMOCOOL CATHETER, CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/25/2013|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD AND TO ESTABLISH MINIMUMSPECIFICATIONS FOR CHAMBER PARAMETERS FOR TWO OF THE CHAMBERS USED.
P980035|S317|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPR, ADVISA DR MRI IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/27/2013|05/15/2013|||APPR|APPROVAL FOR TWO MINOR DESIGN CHANGES TO THE L310 INTEGRATED CIRCUIT FOR THE ADVISA DR MRI DEVICE.
P970051|S107|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|11/13/2013|||APPR|APPROVAL FOR INTRODUCTION OF A CONTAINED HELIUM LEAK TEST.
P090013|S090|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2013|04/11/2013|||OK30|REDUCTION OF THE HYBRID BURN-IN TIME FOR THE ADVISA DR,  ADVISA DR MRI IPGS, REVO MRI IPG, CONSULTA AND SYNCRA CRT-PS.
P100041|S024|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2013|04/18/2013|||APPR|APPROVAL FOR IMPLEMENTATION OF MORE DETAILED CRIMPER MANUFACTURING INSTRUCTIONS AND ADDITIONAL QUALITY CONTROL STEPS TO ENHANCE THE SAFETY OF THE CRIMPER DEVICES.
P110021|S010|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER  HEART VALVE|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2013|04/18/2013|||APPR|APPROVAL FOR IMPLEMENTATION OF MORE DETAILED CRIMPER MANUFACTURING INSTRUCTIONS AND ADDITIONAL QUALITY CONTROL STEPS TO ENHANCE THE SAFETY OF THE CRIMPER DEVICES.
P990046|S032|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2013|06/07/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN MINNEAPOLIS,MINNESOTA.
P030005|S097|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CARDIAC RESYNCHRONIZATION THERAPY -PACEMAKER (CRT-P)|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|04/25/2013|||OK30|ADD AN ADDITIONAL LASER WELD SYSTEM TO THE MANUFACTURING PROCESS.
P010012|S325|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, COGNIS, ENERGEN, AND INCEPTA CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|04/26/2013|||OK30|CHANGES TO THE BATTERY MANUFACTURING PROCESS MONITORING.
P960040|S290|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|04/26/2013|||OK30|CHANGES TO THE BATTERY MANUFACTURING PROCESS MONITORING.
P960040|S291|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS|LWP|CV|30-Day Notice||N|03/29/2013|04/12/2013|||OK30|NEW SOFTWARE ROUTINE FOR THE HIGH VOLTAGE CAPACITOR MANUFACTURING PROCESS.
P010012|S326|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, COGNIS, ENERGEN, AND INCEPTA CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2013|04/12/2013|||OK30|NEW SOFTWARE ROUTINE FOR THE HIGH VOLTAGE CAPACITOR MANUFACTURING PROCESS.
P980041|S023|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2013|06/07/2013|||APPR|APPROVAL FOR MODIFICATION OF A SAMPLE PROBE USED IN THE UNICEL DXI600, 800 AND THE UNICEL DXC 660I, 680I, 860I, AND 880I.
P970038|S022|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2013|06/07/2013|||APPR|APPROVAL FOR MODIFICATION OF A SAMPLE PROBE USED IN THE UNICEL DXI600, 800 AND THE UNICEL DXC 660I, 680I, 860I, AND 880I.
P850048|S033|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2013|06/07/2013|||APPR|APPROVAL FOR MODIFICATION OF A SAMPLE PROBE USED IN THE UNICEL DXI600, 800 AND THE UNICEL DXC 660I, 680I, 860I, AND 880I.
P090026|S006|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|03/29/2013|06/07/2013|||APPR|APPROVAL FOR MODIFICATION OF A SAMPLE PROBE USED IN THE UNICEL DXI600, 800 AND THE UNICEL DXC 660I, 680I, 860I, AND 880I.
P060002|S030|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice||N|03/29/2013|04/22/2013|||OK30|IMPLEMENT A NEW SYSTEM FOR PRINTING PRODUCT LABELS FOR THE DEVICE.
P080007|S016|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice||N|03/29/2013|04/22/2013|||OK30|IMPLEMENT A NEW SYSTEM FOR PRINTING PRODUCT LABELS FOR THE DEVICE.
P070014|S038|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice||N|03/29/2013|04/22/2013|||OK30|IMPLEMENT A NEW SYSTEM FOR PRINTING PRODUCT LABELS FOR THE DEVICE.
P000006|S033|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/2013|05/31/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE DEFLATION BUTTON AND VALVE OF THE PUMP COMPONENT, AND RELATED CHANGES TO THE LABELING TO REFLECT THESE MODIFICATIONS.
P790007|S036|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT, MODEL 150|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|04/30/2013|||OK30|INSTALLATION OF A NEW COMPRESSED AIR SYSTEM.
P970031|S040|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|04/30/2013|||OK30|INSTALLATION OF A NEW COMPRESSED AIR SYSTEM.
P030017|S161|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|05/01/2013|||OK30|MANUFACTURING FACILITY MOVE FOR THE PACKAGING POUCH SUPPLIER.
P980016|S406|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|04/30/2013|||OK30|ADDITIONAL INSPECTION ACTIVITY DURING THE MANUFACTURING OF BATTERIES.
P010031|S369|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|04/30/2013|||OK30|ADDITIONAL INSPECTION ACTIVITY DURING THE MANUFACTURING OF BATTERIES.
P010012|S327|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA,ENERGEN,PUNCTUA,COGNIS CRT-DS|LWP|CV|30-Day Notice||N|04/01/2013|04/26/2013|||OK30|OPTIMIZATION OF WELD PROCESS PARAMETERS AND REMOVAL OF A WELD INSPECTION CRITERION FOR THE  DEVICES.
P960040|S292|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS|LWP|CV|30-Day Notice||N|04/01/2013|04/26/2013|||OK30|OPTIMIZATION OF WELD PROCESS PARAMETERS AND REMOVAL OF A WELD INSPECTION CRITERION FOR THE  DEVICES.
P100047|S019|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/2013|05/22/2013|||APPR|APPROVAL FOR A CHANGE OF THE ADHESIVE TAPE AND THE ADDITION OF 4 RIBS (POSTS/SHELVES) TO HOLD THE LCD GLASS IN ITS POSITION ON THE CONTROLLER.
P980043|S040|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|04/30/2013|||OK30|INSTALLATION OF A NEW COMPRESSED AIR SYSTEM.
P990064|S048|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS, MODELS 305 AND 310|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|04/30/2013|||OK30|INSTALLATION OF A NEW COMPRESSED AIR SYSTEM.
P990064|S049|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|07/31/2013|||APPR|APPROVAL TO USE TWO NEW AUTOCLAVES.
P110016|S008|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL FLEX ABLATION CATHETER|OAD|CV|Panel Track||N|04/01/2013|12/18/2013|13M-1693|01/15/2014|APPR|APPROVAL FOR THE THERAPY COOL FLEX ABLATION CATHETER. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND 1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
P980043|S041|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHETIC HEART VALVE|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|07/31/2013|||APPR|APPROVAL TO USE TWO NEW AUTOCLAVES.
P790007|S037|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|07/31/2013|||APPR|APPROVAL TO USE TWO NEW AUTOCLAVES.
P870078|S020|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|07/31/2013|||APPR|APPROVAL TO USE TWO NEW AUTOCLAVES.
P970031|S041|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|07/31/2013|||APPR|APPROVAL TO USE TWO NEW AUTOCLAVES.
P020050|S012|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Change Design/Components/Specifications/Material|N|04/01/2013|09/27/2013|13M-1321|10/30/2013|APPR|APPROVAL FOR THE ALLEGRETTO WAVE® EYE-Q 400HZ EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING: THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (TOPOGRAPHER) AND T-CAT TREATMENT PLANNING SOFTWARE IS INDICATED FOR PERFORMING TOPOGRAPHY-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (TOPO-GUIDED (T-CAT) LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF UP TO -9.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.¿
P870078|S019|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|04/30/2013|||OK30|INSTALLATION OF A NEW COMPRESSED AIR SYSTEM.
P110007|S003|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICES (OVD)|LZP|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|05/28/2013|||APPR|APPROVAL FOR THE USE OF A NEW RAW MATERIAL SUPPLIER FOR THE NUTRIENT SOURCE USED IN THE SODIUM HYALURONATE MANUFACTURING PROCESS.
P110007|S004|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|05/08/2013|||OK30|TRANSFER THE PREPARATION OF THE WORKING CELL BANK TO LIFECORE BIOMEDICAL.
P970031|S042|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|09/24/2013|||APPR|INSTALLATION OF A NEW REVERSE OSMOSIS, DE-IONIZED WATER SYSTEM.
P020004|S081|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|05/02/2013|||OK30|ALTERNATE FEP FILM SUPPLIER AND A CHANGE FROM IN-PROCESS TESTING TO THE RAWMATERIAL TESTING FOR CERTAIN TESTS PERFORMED BY THE NEW QUALIFIED SUPPLIER.
P040043|S052|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESEIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|05/02/2013|||OK30|ALTERNATE FEP FILM SUPPLIER AND A CHANGE FROM IN-PROCESS TESTING TO THE RAWMATERIAL TESTING FOR CERTAIN TESTS PERFORMED BY THE NEW QUALIFIED SUPPLIER.
P040045|S039|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|04/29/2013|||OK30|CHANGE THE QUALITY CONTROL SAMPLING PLAN FOR PACKAGE INTEGRITY TESTING OF VISTAKON BRAND CONTACT LENSES.
N18033|S072|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|04/29/2013|||OK30|CHANGE THE QUALITY CONTROL SAMPLING PLAN FOR PACKAGE INTEGRITY TESTING OF VISTAKON BRAND CONTACT LENSES.
P960040|S293|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2013|04/30/2013|||OK30|AUTOMATION OF THE EXISTING PROCESS FOR THE FEEDTHRU WELD LEAK TEST.
P030017|S162|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2013|04/30/2013|||OK30|ADD AN ALTERNATE SUB-SUPPLIER FOR THE FEEDTHROUGH FLANGE AND TO ADD AN ALTERNATE VACUUM BAKE OVEN FOR THE FEEDTHROUGH.
P100014|S009|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/01/2013|01/14/2014|||APPR|APPROVAL FOR THE REVISION OF THE PRESCRIBING INFORMATION TO INCLUDE 24 AND 26 MONTH DATA.
P910001|S065|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/2013|01/14/2014|||APPR|APPROVAL FOR NEW CIRCUITRY AND OPTICAL COMPONENTS TO IMPROVE CONTROL OF THE REGULATED ENERGY OUTPUT OF THE CVX-300 LASER GENERATOR.
P990064|S050|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|09/24/2013|||APPR|INSTALLATION OF A NEW REVERSE OSMOSIS, DE-IONIZED WATER SYSTEM.
P980043|S042|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHETIC HEART VALVE|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|09/24/2013|||APPR|INSTALLATION OF A NEW REVERSE OSMOSIS, DE-IONIZED WATER SYSTEM.
P790007|S038|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|09/24/2013|||APPR|INSTALLATION OF A NEW REVERSE OSMOSIS, DE-IONIZED WATER SYSTEM.
P070015|S107|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2013|09/23/2014|||APPR|APPROVAL FOR A CHANGE TO THE PARTICULATE TEST METHOD AND PARTICULATE SPECIFICATION USED FOR THE STABILITY TESTING OF THE XIENCE V AND XIENCE NANO EVEROLIMUS-ELUTING CORONARY STENT SYSTEMS.
P040027|S029|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|05/02/2013|||OK30|ALTERNATE FEP FILM SUPPLIER AND A CHANGE FROM IN-PROCESS TESTING TO THE RAWMATERIAL TESTING FOR CERTAIN TESTS PERFORMED BY THE NEW QUALIFIED SUPPLIER.
P040037|S048|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|05/02/2013|||OK30|ALTERNATE FEP FILM SUPPLIER AND A CHANGE FROM IN-PROCESS TESTING TO THE RAWMATERIAL TESTING FOR CERTAIN TESTS PERFORMED BY THE NEW QUALIFIED SUPPLIER.
P870078|S021|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2013|09/24/2013|||APPR|INSTALLATION OF A NEW REVERSE OSMOSIS, DE-IONIZED WATER SYSTEM.
P010012|S328|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, COGNIS, ENERGEN, INCEPTA CRT-D'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2013|04/30/2013|||OK30|AUTOMATION OF THE EXISTING PROCESS FOR THE FEEDTHRU WELD LEAK TEST.
P950037|S121|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|PHILOS DR-T,PHILOS II DR-T,CYLOS DR-T,EVIA DR-T/EVIA SR-T,ENTOVIS DR-T/ENTOVIS SR-T,ESTELLA DR-T/ESTELLA SR-T|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/03/2013|05/08/2013|||APPR|APPROVAL FOR THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA.
P980023|S052|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|BELOS VR-T|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/03/2013|05/08/2013|||APPR|APPROVAL FOR THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA..
P000009|S054|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS DR-T,BELOS A+-T,LEXOS DR-T/LEXOS VR-T,XELOS DR-T,LUMOS DR-T/LUMOS VR-T|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/03/2013|05/08/2013|||APPR|APPROVAL FOR THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA.
P050023|S063|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300 DR-T/LUMAX 340 DR-T,LUMAX 300 VR-T/LUMAX 340 VR-T,LUMAX 500 DR-T/LUMAX 540 DR-T,LUMAX 500 VR-T/LUMAX 540 VR-T,|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/03/2013|05/08/2013|||APPR|APPROVAL FOR THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA.
P070008|S041|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV-T,EVIA HF-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/03/2013|05/08/2013|||APPR|APPROVAL FOR THE UPDATED VERSION 3.22.0 OF HOME MONITORINGSERVICE CENTER INCLUDING THE FEATURES:1) IMPLEMENTATION OF REMOTE SCHEDULING; AND2) AUTOMATIC EXPORT OF EHR DATA.
P810002|S084|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT MECHANICAL HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2013|08/19/2013|||APPR|APPROVAL FOR A CHANGE TO THE INSPECTION SAMPLING PLAN FOR FINAL LEAFLET EAR THICKNESS DIMENSIONS.
P970051|S108|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2013|06/12/2013|||APPR|APPROVAL FOR MODIFICATION TO THE CLEANING PROCESS FOR INTRACOCHLEAR ELECTRODES.
P110042|S007|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2013|04/30/2013|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF THE LOW POWER HYBRID (LPH) ASSEMBLY OF THE S-ICD® SYSTEM, INCLUDING NEW COMPONENTS FOR THE LPH.
P100040|S011|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2013|05/02/2013|||OK30|ADD MANUFACTURING STEPS RELATED TO THE STENT RING AND MARKERS TO AN EXISTING INTERNAL MANUFACTURING FACILITY.
P070007|S037|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2013|05/02/2013|||OK30|ADD MANUFACTURING STEPS RELATED TO THE STENT RING AND MARKERS TO AN EXISTING INTERNAL MANUFACTURING FACILITY.
P070027|S036|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT AAA STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2013|05/02/2013|||OK30|ADD MANUFACTURING STEPS RELATED TO THE STENT RING AND MARKERS TO AN EXISTING INTERNAL MANUFACTURING FACILITY.
P100021|S025|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2013|05/02/2013|||OK30|ADD MANUFACTURING STEPS RELATED TO THE STENT RING AND MARKERS TO AN EXISTING INTERNAL MANUFACTURING FACILITY.
P080012|S016|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE IMPLANTABLE PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|04/05/2013|07/02/2013|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE CANNULA STRAIN RELIEF AND FILTER SEAL, WHICH ARE BOTH COMPONENTS OF THE IMPLANTABLE PUMP.
P970003|S161|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM LEADS|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2013|05/03/2013|||OK30|ADDITION OF AN ALTERNATIVE ELASTOMER MIXING PROCESS FOR VARIOUS LEAD ASSEMBLY MODELS.
P080030|S008|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2013|05/01/2013|||OK30|CHANGE QC TESTING OF THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM.
P060002|S031|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2013|04/29/2013|||OK30|CHANGE TO PARAMETRIC RELEASE OF ETHYLENE OXIDE STERILIZED PRODUCT.
P070015|S108|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/08/2013|06/07/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010031|S370|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,VIVA S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|05/03/2013|||OK30|IMPLEMENTATION OF AN UPDATED ACCEPTANCE CRITERION FOR EVALUATION OF INSULATOR MATERIALS USED IN THE MANUFACTURE OF THE SUBJECT ICDS AND CRT-D DEVICES.
P980016|S407|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|05/03/2013|||OK30|IMPLEMENTATION OF AN UPDATED ACCEPTANCE CRITERION FOR EVALUATION OF INSULATOR MATERIALS USED IN THE MANUFACTURE OF THE SUBJECT ICDS AND CRT-D DEVICES.
P920015|S108|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SPLITTER/ADAPTOR, DF-4 IMPLANT TOOL KIT FOR MDT LEADS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|09/10/2013|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A NEW INSPECTION FIXTURE AT THE SUPPLIER.
P060033|S074|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|05/08/2013|||OK30|CHANGE TO THE IN-PROCESS SAMPLING REQUIREMENTS OF SEVERAL EXTRUDED TUBING COMPONENTS.
P050028|S031|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|CCOBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|05/07/2013|||OK30|CHANGE FOR AN OPTIMIZATION OF THE KIT QC FUNCTIONAL TESTING CALCULATION METHOD.
P110013|S010|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|05/08/2013|||OK30|CHANGE TO THE IN-PROCESS SAMPLING REQUIREMENTS OF SEVERAL EXTRUDED TUBING COMPONENTS.
P030009|S064|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|05/08/2013|||OK30|CHANGE TO THE IN-PROCESS SAMPLING REQUIREMENTS OF SEVERAL EXTRUDED TUBING COMPONENTS.
P980016|S408|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR,  EVERA S VR,  EVERA XT DR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|05/03/2013|||OK30|ADDITION OF A SPECIFIC ACCEPTANCE CRITERION TO ALLOW DELAMINATION FOR THE LOWER WIRE BONDPAD ON THE U31 FET; 2) TWO PROCESS ADJUSTMENT CHANGES FOR THE INTEGRATED CIRCUIT AT MEDTRONIC SUPPLIER3) THE IMPLEMENTATION OF ADDITIONAL TOOLING FOR THE CASE LINER ASSEMBLY MANUFACTURINGPROCESS; 4) A CHANGE TO THE HYBRID CD SURGE MANUFACTURING TEST SOFTWARE; 5) THREE CHANGES INCLUDING THE IMPLEMENTATION OF A BURN-IN OVEN FOR THE RECOVERY AND FINAL VOLTAGE MEASUREMENTS STEPS FOR THE BATTERIES OF THE SUBJECT DEVICES, CORRECTIONS TO THESUBJECT SYSTEMS' BATTERY TEST SPECIFICATION TO ALIGN WITH MEASUREMENT SYSTEM CAPABILITIES,AND CONSOLIDATION OF MEASUREMENT STEPS WITHIN THE BURN IN TEST PROCESS; AND6) THE IMPLEMENTATION OF ADDITIONAL LASER WELDERS TO INCREASE MANUFACTURING CAPACITY.
P980016|S409|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR,  EVERA S VR,  EVERA XT DR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|05/03/2013|||OK30|THE IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1; 2) THE APPROVAL OF MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA;  3) NEW PRESSURE TEST EQUIPMENT TO VERIFY HERMETICITY; 4) MODIFICATIONS TO A CONTROLLED ENVIRONMENT; 5) A CHANGE TO THE DESCUM AND CLEANING PROCESS FOR THE 3UM CMOS INTEGRATED CIRCUIT; AND 6) A NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.
P050038|S017|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA  AH|LMG|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2013|08/02/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN  MINNEAPOLIS, MINNESOTA.
P100034|S004|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOTTF-100A SYSTEM|NZK|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/08/2013|08/08/2013|||APPR|APPROVAL FOR TRANSFERRING THE RESPONSIBILITY OF PERFORMING THE NOVOTAL TRANSDUCER ARRAY MAPPING FROM NOVOCURES STAFF TO TRAINED PHYSICIANS RESPONSIBLE FOR PRESCRIBING THE DEVICE.
P030050|S017|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/05/2013|10/10/2014|||APPR|APPROVAL FOR A CHANGE IN PRODUCT LABELING TO DESCRIBE THE RESULTS OF A POSTAPPROVAL STUDY IN PATIENTS WITH HIV ASSOCIATED LIPOATROPHY.
P980016|S410|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2013|05/07/2013|||OK30|SEVEN PREVIOUSLY APPROVED MANUFACTURE CHANGES FOR THE DEVICES. THOSE ARE:1) UPDATE THE CMOS IC PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATE THE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 ICS;3) ADD THE HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE; 4) UPDATE THE AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER (AAEC); 5) IMPLEMENT A NEW CLEANING PROCESS AND A CURING OVEN; 6) IMPLEMENT A MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS; AND7) UPDATE TO THE TEST SYSTEM SOFTWARE SHELL.
P000053|S048|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2013|04/30/2013|||OK30|REPLACEMENT OF A MANUAL PRESSURE TESTING UNIT WITH A SEMI-AUTOMATED PRESSURE TESTER UNIT.
P980016|S411|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR|LWS|CV|30-Day Notice||N|04/09/2013|04/26/2013|||OK30|ADDITIONAL ASSEMBLY LINE WIRE BOND WORK CELL, AND CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF GOLD PLATED DEVICE COMPONENTS.
P010031|S371|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2013|05/07/2013|||OK30|SEVEN PREVIOUSLY APPROVED MANUFACTURE CHANGES FOR THE DEVICES. THOSE ARE:1) UPDATE THE CMOS IC PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATE THE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 ICS;3) ADD THE HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE; 4) UPDATE THE AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER (AAEC); 5) IMPLEMENT A NEW CLEANING PROCESS AND A CURING OVEN; 6) IMPLEMENT A MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS; AND7) UPDATE TO THE TEST SYSTEM SOFTWARE SHELL.
P980035|S318|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA MRI|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2013|05/07/2013|||OK30|SEVEN PREVIOUSLY APPROVED MANUFACTURE CHANGES FOR THE DEVICES. THOSE ARE:1) UPDATE THE CMOS IC PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATE THE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 ICS;3) ADD THE HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE; 4) UPDATE THE AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER (AAEC); 5) IMPLEMENT A NEW CLEANING PROCESS AND A CURING OVEN; 6) IMPLEMENT A MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS; AND7) UPDATE TO THE TEST SYSTEM SOFTWARE SHELL.
P100013|S009|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2013|05/09/2013|||OK30|CHANGE IN THE PROCESSING OF THREE COMPONENTS FROM SINGLE CAVITYMOLD TO MULTI CAVITY MOLDS FOR THE EXOSEAL VASCULAR CLOSURE DEVICE.
P000027|S018|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA IMMUNOASSAY|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/2013|03/21/2014|||APPR|APPROVAL FOR THE SOFTWARE CHANGE FROM VERSION 06-07 TO 06-08 ON THEELECSYS 2010 ANALYZER TO CORRECT THE POSSIBILITY OF INCORRECT RESULTS AFTER AUTOMATIC DILUTION.
P990056|S020|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/2013|03/21/2014|||APPR|APPROVAL FOR THE SOFTWARE CHANGE FROM VERSION 06-07 TO 06-08 ON THEELECSYS 2010 ANALYZER TO CORRECT THE POSSIBILITY OF INCORRECT RESULTS AFTER AUTOMATIC DILUTION.
P100032|S009|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/2013|03/21/2014|||APPR|APPROVAL FOR THE SOFTWARE CHANGE FROM VERSION 06-07 TO 06-08 ON THEELECSYS 2010 ANALYZER TO CORRECT THE POSSIBILITY OF INCORRECT RESULTS AFTER AUTOMATIC DILUTION.
P990012|S020|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/2013|03/21/2014|||APPR|APPROVAL FOR THE SOFTWARE CHANGE FROM VERSION 06-07 TO 06-08 ON THEELECSYS 2010 ANALYZER TO CORRECT THE POSSIBILITY OF INCORRECT RESULTS AFTER AUTOMATIC DILUTION.
P010054|S022|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/2013|03/21/2014|||APPR|APPROVAL FOR THE SOFTWARE CHANGE FROM VERSION 06-07 TO 06-08 ON THEELECSYS 2010 ANALYZER TO CORRECT THE POSSIBILITY OF INCORRECT RESULTS AFTER AUTOMATIC DILUTION.
P080011|S023|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2013|05/07/2013|||OK30|MINOR MODIFICATION TO THE MANUFACTURING PROCESS.
P860003|S073|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2013|05/06/2013|||OK30|MANUFACTURING PROCESS CHANGE FOR ONE OF THE CELLEX SYSTEM COMPONENTS.
P110032|S002|LOMBARD MEDICAL TECHNOLOGIES INC|15420 LAGUNA CANYON ROAD|SUITE 260|IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/2013|06/17/2013|||APPR|APPROVAL FOR SEVERAL MODIFICATIONS TO THE OUTER SHEATH OF THE DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY SYSTEM AND IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, IMPLANTS, AND ACCESSORIES; 2) AORTIC NECK LANDING ZONE DIAMETERS WITH A RANGE OF 19MM TO 29MM; 3) NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF 15MM;  4) INFRARENAL AORTIC NECK ANGULATIONS INCLUDING THOSE UP TO AND INCLUDING 90°; 5) COMMON ILIAC LANDING ZONE DIAMETERS WITH A RANGE OF 9MM TO 19MM; AND 6) DISTAL FIXATION LENGTH OF 15MM.
P930039|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P030053|S014|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/10/2013|10/01/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980035|S319|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA MRI IPG,RELIA IPG|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P970051|S109|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|05/06/2013|||OK30|UPGRADES TO THE NUCLEUS 5 SERVICE TEST SYSTEM SOFTWARE.
P980050|S081|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P010015|S197|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, SYNCRA CRT-P|OJX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P980016|S412|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRTUOSO II DR/VR IC|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P950024|S048|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P920015|S109|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P000040|S030|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2013|07/19/2013|||APPR|APPROVAL FOR A CHANGE TO THE GOLD THICKNESS SPECIFICATION OF THE CASSETTE CONTACT PINS FROM FLASH GOLD TO >= 15 MICRON-INCHES AND A MODIFICATION TO THE SHIPPER TRAY SO THAT THE CONTACT PINS DO NOT CONTACT ITS LID.
P900061|S120|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P890003|S272|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P840001|S238|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|05/10/2013|||OK30|Three software changes and a control test method change for the SureScan MRI System.
P950008|S009|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000 OCULAR ENDOTAMPONADE|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|05/15/2013|||OK30|ALTERNATE THERMAL EXTRACTION.
P030036|S056|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECT SECURE LEAD|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P060039|S044|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P820021|S036|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|VIFILCON A CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|05/08/2013|||OK30|TEST METHOD CHANGES AND/OR IMPROVEMENTS.
P080006|S052|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P980049|S082|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR AND DR, PARADYM RF VR AND DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|05/03/2013|||OK30|EXTENDING THE USE OF A PLASMA CLEANING STEP USED DURING THE MICRO-ELECTRONIC ASSEMBLY PROCESS.
P060027|S050|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D, PARADYM RF CRT-D|NIK|CV|30-Day Notice||N|04/10/2013|05/03/2013|||OK30|EXTENDING THE USE OF A PLASMA CLEANING STEP USED DURING THE MICRO-ELECTRONIC ASSEMBLY PROCESS.
P850089|S095|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,IMPULSE II LEAD|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P830061|S089|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD,CAPSURE SP LEAD,VITATRON CRYSTALINE LEAD,VITATRON EXCELLENCE PS+LEAD|NVY|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P010031|S372|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D,& XT CRT-D, BRAVA CRT-D, VIVA S CRT-D||CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P090013|S091|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD, REVO MRI IPG|LWP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|12/24/2013|||APPR|APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.
P110013|S011|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2013|08/22/2013|||APPR|APPROVAL FOR A CHANGE TO THE SAMPLE PREPARATION EXTRACTION SOLUTION AND DILUENTS FOR THE BUTYLATED HYDROXYTOLUENE (BHT) ANALYTICAL QUALITY CONTROL TEST.
P980022|S134|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2013|07/08/2013|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE PARADIGM REAL-TIME REVELINSULIN PUMP (MMT-523, MMT-523K, MMT-723, AND MMT-723K) APPLICATION SOFTWARE. THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME REVEL SYSTEM.
P070026|S013|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/11/2013|05/07/2013|||APPR|APPROVAL FOR A CHANGE IN THE LABELING OF THE PACKAGE INSERT AND SURGICAL TECHNIQUE.
P010047|S029|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice||N|04/11/2013|04/24/2013|||OK30|CHANGES IN THE STERILIZATION PROCEDURES FOR THE EXTENDED TIPS AND SPARE TIPS PROVIDED WITH THE PROGEL PLEURAL AIR LEAK SEALANT KIT.
P100018|S007|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE, PIPELINE EMBOLIZATION DEVICE|OUT|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2013|05/09/2013|||OK30|MANUFACTURING PROCESS CHANGE FOR THE PROTECTIVE COIL OF THE PIPELINEEMBOLIZATION DEVICE DELIVERY SYSTEM.
P980041|S024|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/12/2013|08/20/2013|||APPR|APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS.
P970038|S023|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/12/2013|08/20/2013|||APPR|APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS.
P850048|S034|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/12/2013|08/20/2013|||APPR|APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS.
P090026|S007|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/12/2013|08/20/2013|||APPR|APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS.
P040037|S049|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2013|05/14/2013|||OK30|AUTOMATE SELECTION OF RAW MATERIAL/ COMPONENTS DURING DEVICE/CATHETER ASSEMBLY.
P060022|S016|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBERS INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2013|07/01/2013|||APPR|APPROVAL FOR A LABELING CHANGE TO INCLUDE THE ADDITION OF A NEW INTRAOCULAR LENS (IOL) INSERTER, INJ100, IN THE DIRECTIONS FOR USE.
P090022|S017|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|IOL DELIVERY SYSTEM|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2013|07/25/2013|||APPR|APPROVAL FOR A DIFFERENT DELIVERY SYSTEM, THE DEVICE WHICH HOLDS THE INTRAOCULAR LENS (IOL) IN PLACE WITHIN ITS SALINE FILLED VIAL.
P880006|S086|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|REGENCY, SENSLOG AND DIALOG|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2013|05/14/2013|||OK30|ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.
P030035|S110|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER, FRONTIER II AND ANTHEM|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2013|05/14/2013|||OK30|ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.
P910023|S314|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CADENCE, CADET, CONTOUR, CONTOUR 11/MD, ADGSTROM II/MD, PROFILEII/MD, PHOTON, PHOTON MICRO|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2013|05/14/2013|||OK30|ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.
P030054|S245|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|EPIC HF, EPIC + HR, EPIC II HF, EPIC II+ HF, ATLAS HF, ATLAS+HF, ATLAS II +HF, ATLAS, PROMOTE, PROMOTE +|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2013|05/14/2013|||OK30|ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.
P880086|S232|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, ZEPHYR, ACCENT, TRIOLOGY, SYNCHRONY AND PARAGON|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2013|05/14/2013|||OK30|ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.
P970013|S056|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2013|05/14/2013|||OK30|ALTERNATE STERILIZATION CYCLE AT THE PUERTO RICO MANUFACTURING FACILITY.
P840001|S239|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|VECTRIS SURESCAN MRI 1X8 LEADS, VECTRIS 1X8 TRIALING LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2013|05/16/2013|||OK30|MODIFICATIONS TO THE MANUFACTURING PROCESS FOR LEADS USED WITH IMPLANTABLE NEUROSTIMULATORS, EXTERNAL NEUROSTIMULATORS, AND ACCESSORIES FOR SPINAL CORD STIMULATION.
P980035|S320|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG,RELIA IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2013|06/18/2013|||APPR|APPROVAL FOR CHANGES TO THE BURN-IN SPECIFICATIONS OF THE BATTERIES USED IN YOUR CARDIAC PACEMAKERS
P990081|S018|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2013|05/13/2013|||OK30|ADDITION OF A NEW SUPPLIER OF PRINTED CIRCUIT BOARD ASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS.
P020055|S007|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2013|05/13/2013|||OK30|ADDITION OF A NEW SUPPLIER OF PRINTED CIRCUIT BOARD ASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS.
P040027|S030|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2013|04/29/2013|||OK30|CHANGE FROM A HEAT STAMPING TO A LASER MARKING METHOD.
P030008|S011|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT LASER SYSTEM|LZS|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2013|05/15/2013|||APPR|APPROVAL FOR THE LABELING CHANGES OF WAVELIGHT® EX 500 EXCIMER LASER SYSTEM AND WAVELIGHT LASER SYSTEM.
P090013|S092|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN PACKING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2013|05/14/2013|||OK30|REPLACING THE TEST USED FOR IN-PROCESS MONITORING OF AN INNER INSULATION PARAMETER.
P020050|S013|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 EXCIMER LASER SYSTEM|LZS|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2013|05/15/2013|||APPR|APPROVAL FOR THE LABELING CHANGES OF WAVELIGHT® EX 500 EXCIMER LASER SYSTEM AND WAVELIGHT LASER SYSTEM.
P100027|S008|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2013|05/13/2013|||OK30|ADDITION OF A NEW SUPPLIER OF PRINTED CIRCUIT BOARD ASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS.
P110019|S043|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2013|07/15/2013|||APPR|APPROVAL TO UPDATE THE LABELING FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT RAPID EXCHANGE (RX) SYSTEM TO REFLECT A 24-MONTH SHELF LIFE.
N18286|S025|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM (ABSORBABLE GELATIN) POWDER,USP|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2013|06/03/2013|||APPR|APPROVAL FOR LABEL CHANGES TO THE INSTRUCTIONS FOR USE: FOR THE FOLLOWING DEVICE ITERATIONS:1) GELFOAM PLUS -ORIGINAL SPONGE IFU- NEEDLELESS;2) GELFOAM PLUS- POWDER IFU-NEEDLELESS; 3) GELFOAM PLUS - COMPRESSED SPONGE IFU  NEEDLELESS;4) GELFOAM ABSORBABLE GELATIN) SPONGE; 5) GELFOAM (ABSORBABLE GELATIN) DENTAL SPONGE; 6) GELFOAM (ABSORBABLE GELATIN) COMPRESSED SPONGE; AND 7) GELFOAM (ABSORBABLE GELATIN) POWDER.ADD THE PRECAUTIONARY STATEMENT:POSITIONING OF THE PATIENT RESULTING IN NEGATIVE PERIPHERAL VENOUS PRESSURE DURING A PROCEDURE HAS BEEN REPORTED TO BE A CONTRIBUTING FACTOR RESULTING IN LIFE-THREATENING THROMBOEMBOLIC EVENTS.2. FOR THE FOLLOWING DEVICE ITERATIONS:1) GELFOAM (ABSORBABLE GELATIN) SPONGE; 2) GELFOAM (ABSORBABLE GELATIN) DENTAL SPONGE; 3) GELFOAM (ABSORBABLE GELATIN) COMPRESSED SPONGE; AND  4) GELFOAM (ABSORBABLE GELATIN) POWDER.MAKE MINOR CHANGES TO THE EXISTING PRECAUTIONARY STATEMENT:  ALTHOUGH THE SAFETY AND EFFICACY OF THE COMBINED USE OF GELFOAM WITH OTHER AGENTS SUCH AS TOPICAL THROMBIN HAS NOT BEEN EVALUATED IN PHARMACIA- CONTROLLED CLINICAL TRIALS, IF IN THE PHYSICIANS JUDGMENT CONCURRENT USE OF TOPICAL THROMBIN OTHER AGENTS IS MEDICALLY ADVISABLE, THE PRODUCT LITERATURE FOR THAT AGENT SHOULD BE CONSULTED FOR COMPLETE PRESCRIBING INFORMATION.
P890003|S273|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, VITATRON LEGACY, VITATRON LEGACY II|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P820003|S120|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PASYS,PASYS ST,SPECTRAX S,SPECTAX SX,SPECTRAX SX-HT,SPECTRAX SXT,SYMBIOS,SYMBIOS(AA),SYNERGYST|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P850051|S080|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P900061|S121|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM,JEWEL,MOCRO JEWEL,JEWEL PLUS,MICRO JEWEL II,PCD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P930022|S015|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LEGEND PLUS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P970012|S093|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|KAPPA 400|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P980016|S413|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P090013|S093|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI AND ENRHYTHM MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P010031|S373|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO-II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC II MARQUIS, INSY|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P010015|S198|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P INSYNC, INSYNC III, SYNCRA CRT-P AND CONCERTO|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P980050|S082|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P990001|S111|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITATRON (IPG'S)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P980035|S321|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|KAPPA 800, KAPPA 900, KAPPA 650, KAPPA 700, KAPPA800, KAPPA 900, RELIA, SENSIA, SIGMA, VERSA JEWEL AF GEM III AT|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2013|06/11/2013|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P100010|S024|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT AND ARTIC FRONT ADVANCE|OAE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2013|06/20/2013|||APPR|APPROVAL TO REMOVE THE PLANARITY SPECIFICATION AND ASSOCIATED FINAL DEVICE OUT-OF-PLANE MEASUREMENT.
P000008|S031|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/18/2013|09/24/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P090018|S019|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM IMPLANTABLE HEARING SYSTEM|OAF|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/19/2013|05/17/2013|||APPR|APPROVAL FOR THE FOLLOWING: 1) REVISIONS TO THE INSTRUCTIONS FOR USE FOR THE IMPLANTING SURGEON; 2) A MANUAL TO INFORM AUDIOLOGISTS ON THE PROGRAMMING OF THE ESTEEM SYSTEM; AND 3) FOR MAKING MANUALS, WHICH ARE MADE REDUNDANT BY THE FORMER LABELING CHANGES, OBSOLETE.
P960004|S060|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROX LEAD|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/2013|09/09/2013|||APPR|APPROVAL TO CHANGE THE PRIMER FORMULATION USED ON FINELINE II LEADSUBASSEMBLIES, AS WELL AS TO RELOCATE MANUFACTURING OF SOME SUBASSEMBLIES IN-HOUSE WITH MINOR ASSOCIATED DESIGN CHANGES.
P030004|S006|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM|MFE|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2013|05/27/2014|||APPR|APPROVAL FOR THE APOLLO ONYX DELIVERY MICRO CATHETER THAT WILL BE MANUFACTURED AT MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR IN IRVINE, CALIFORNIA.
P870072|S053|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD)|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/22/2013|06/21/2013|||APPR|APPROVAL FOR THE CHANGE IN SECONDARY PACKAGING OF THE VAD SEALED ARTERIAL CANNULA AND THE INTERMEDIATE BULK SHIPMENT CONFIGURATION.
P930014|S068|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/21/2013|||OK30|RELOCATE PACKAGING AND LABELING EQUIPMENT.
P040020|S047|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/21/2013|||OK30|RELOCATE PACKAGING AND LABELING EQUIPMENT.
P110042|S008|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/14/2013|||OK30|USE A NEW RECEIVING INSPECTION WORKBOOK TOOL.
P880087|S022|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE PIECE ANTERIOR CHAMBER|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/21/2013|||OK30|RELOCATE PACKAGING AND LABELING EQUIPMENT.
P840060|S040|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE PIECE POSTERIOR CHAMBER|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/21/2013|||OK30|RELOCATE PACKAGING AND LABELING EQUIPMENT.
P950037|S122|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DEXTRUS,SELOX,SETROX S,SOLOX,TILDA|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/17/2013|||OK30|USE A NEW MAXIMUM STERILIZATION CHAMBER LOAD AT THE CONTRACT STERILIZER FOR THEIR MARKETED LEADS.
P980023|S053|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/17/2013|||OK30|USE A NEW MAXIMUM STERILIZATION CHAMBER LOAD AT THE CONTRACT STERILIZER FOR THEIR MARKETED LEADS.
P050023|S064|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|COROX OTW 75 UP STEROID,COROX OTW 85 UP STEROID|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/17/2013|||OK30|USE A NEW MAXIMUM STERILIZATION CHAMBER LOAD AT THE CONTRACT STERILIZER FOR THEIR MARKETED LEADS.
P900052|S018|SMITHS MEDICAL ASD, INC.|1265 Grey Fox Road||St. Paul|MN|55112||CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL|PORT-A-CATH II  LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM|LNY|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/13/2013|||OK30|CHANGE IN THE SYNTHESIS OF POLYTETRAFLUORO-ETHYLENE (PTFE), A SUBSTANCE USED IN THE MANUFACTURING OF THE COATING SYSTEM FOR THE GUIDEWIRE CONTAINED IN THE PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM. THIS CHANGE IN THE SYNTHESIS OF PTFE IS REQUIRED TO CONFORM TO U.S. ENVIRONMENTAL AGENCY 2010/2015 PFOA STEWARDSHIP PROGRAM RELATED TO THE USE OF PERFLUOROOCTANOIC ACID (PFOA).
P010014|S043|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|06/25/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOMET, INC., WARSAW, INDIANA, FOR MANUFACTURING OF THE MENISCAL BEARINGS.
P090006|S010|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/22/2013|||OK30|ALTERNATE SITE FOR THE PACKAGING POUCH SUPPLIER.
P070008|S042|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CELERITY,COROX|NKE|CV|30-Day Notice||N|04/22/2013|05/17/2013|||OK30|USE A NEW MAXIMUM STERILIZATION CHAMBER LOAD AT THE CONTRACT STERILIZER FOR THEIR MARKETED LEADS.
P110019|S044|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2013|05/21/2013|||OK30|CHANGE TO THE STENT DELIVERY SYSTEM BONDING PROCESS.
P970003|S162|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC)|MUZ|NE|Real-Time Process||N|04/22/2013|07/10/2013|||APPR|APPROVAL FOR A CHANGE TO THE TRANSMIT TO RECEIVE REFRACTORY TIMEWHICH IS A SPECIFICATION OF THE APPLICATION SPECIFIC INTEGRATED CIRCUIT (ASIC) USED IN MODEL 103/104/105 VNS GENERATORS AND THE IMPLEMENTATION OF A SCREENING TEST TO BE PERFORMED AT THEVENDOR (ON SEMICONDUCTOR).
P070016|S007|WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 THORACIC ENDOVASCULAR GRAFT|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/23/2013|05/20/2013|||APPR|APPROVAL FOR UPDATING SEVERAL SECTIONS IN THE IFU REGARDING MAINTAINING HEMOSTASIS, TRIGGER WIRE RELEASE, AND MRI SAFETY INFORMATION.
P100041|S027|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2013|05/22/2013|||APPR|APPROVAL FOR ADDITION OF POLYETHYLENE FOAM TO THE BASE OF THE CRIMPER DURING PACKAGING, A CHANGE TO THE CRIMPER PACKAGE RELEASE TEMPERATURE SET POINT, AND ADDITION OF POUCH INTEGRITY INSPECTIONS FOR ALL SAPIEN ACCESSORIES.
P110021|S013|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWARDS TRANSFEMORAL BALLOON CATHETER, CRIMPER, ASCENDRA BALLOO|NPT|CV|Special (Immediate Track)||N|04/23/2013|05/22/2013|||APPR|APPROVAL FOR ADDITION OF POLYETHYLENE FOAM TO THE BASE OF THE CRIMPER DURING PACKAGING, A CHANGE TO THE CRIMPER PACKAGE RELEASE TEMPERATURE SET POINT, AND ADDITION OF POUCH INTEGRITY INSPECTIONS FOR ALL SAPIEN ACCESSORIES.
P980016|S414|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT|LWS|CV|30-Day Notice||N|04/23/2013|05/14/2013|||OK30|BUTTED CONTACT ETCH TIME CHANGE FOR THE M016 AND M017 INTEGRATED CIRCUITS.
P010031|S374|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice||N|04/23/2013|05/14/2013|||OK30|BUTTED CONTACT ETCH TIME CHANGE FOR THE M016 AND M017 INTEGRATED CIRCUITS.
P050042|S024|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2013|05/22/2013|||OK30|CHANGE TO A SUPPLIER QUALITY CONTROL TEST METHOD AND ACCEPTANCE SPECIFICATIONS FOR AN INCOMING BULK MATERIAL USED IN THE MANUFACTURE OF THE ARCHITECT ANTI-HCV TEST KIT.
P010015|S199|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice||N|04/23/2013|05/14/2013|||OK30|BUTTED CONTACT ETCH TIME CHANGE FOR THE M016 AND M017 INTEGRATED CIRCUITS.
P970003|S163|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY GENERATOR(PULSE AND PULSE DUO) (ASPIREHC)|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2013|05/21/2013|||OK30|ADDITION OF AN ALTERNATIVE LASER WELDING SYSTEM, WHICH IS USED TO WELD THE CASE HALVES AND ANCHOR TABS OF THE VNS THERAPY® GENERATORS.
P980035|S322|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG,ADVISA DR MRI IPG|NVZ|CV|30-Day Notice||N|04/23/2013|05/14/2013|||OK30|BUTTED CONTACT ETCH TIME CHANGE FOR THE M016 AND M017 INTEGRATED CIRCUITS.
P090013|S095|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice||N|04/23/2013|05/14/2013|||OK30|BUTTED CONTACT ETCH TIME CHANGE FOR THE M016 AND M017 INTEGRATED CIRCUITS.
P000036|S016|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2013|05/21/2013|||OK30|CHANGE IN THE SOFTWARE USED TO REGULATE THE DERMAGRAFT CELL CULTURE PROCESS.
P060010|S011|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT|NZC|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2013|08/28/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PROMED PHARMA LLC, IN MINNEAPOLIS, MINNESOTA.
P950032|S072|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2013|07/11/2013|||APPR|APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELLSTRAIN 197 (HEP 197) FOR USE IN THE MANUFACTURE OF APLIGRAF, AND FOR APPROVAL OF A CHANGE FROM THE CURRENT TEST ASSAY FOR DETECTION OF CERTAIN VIRAL CONTAMINANTS TO A REAL-TIME PCR METHOD FROM A CONVENTIONAL GEL-BASED PCR METHOD.
P980023|S054|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2013|01/17/2014|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR SHOCK COILS USED IN THE SUBJECT LEADS.
P970021|S038|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2013|06/20/2013|||APPR|APPROVAL FOR A CHANGE IN PRESSURE TRANSDUCER.
P000036|S017|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT (HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE)|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2013|05/23/2013|||OK30|QUALIFICATION OF ADDITIONAL SEEDING VESSELS, AND PROPOSED A CHANGE IN THE TYPE OF MATERIAL USED FOR THE TUBING AND MANIFOLD ASSEMBLY CONNECTOR FITTINGS.
P860004|S191|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED PUMP AND INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/25/2013|05/23/2013|||APPR|APPROVAL OF LABELING CHANGES FOR DEVICE REFILL KIT MODEL 8551 TO ACCOMMODATE THE POSSIBILITY FOR THE USE OF MULTIPLE SYRINGES DURING KIT REFILL PROCEDURES.
P980035|S323|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2013|05/23/2013|||OK30|USE OF A NEW STERILIZER AND AERATOR.
P930039|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2013|05/23/2013|||OK30|USE OF A NEW STERILIZER AND AERATOR.
P830061|S091|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE BIPOLAR LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2013|05/23/2013|||OK30|USE OF A NEW STERILIZER AND AERATOR.
P090013|S096|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2013|05/23/2013|||OK30|USE OF A NEW STERILIZER AND AERATOR.
P000036|S018|SHIRE REGENERATIVE MEDICINE|11095 TORREYANA ROAD||SAN DIEGO|CA|92121||Dressing, wound and burn, interactive|DERMAGRAFT (HUMAN FIBROBLAST -DERIVED DERMAL SUBSTITUTE)|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2013|05/21/2013|||OK30|ADDITION OF A LAMINAR FLOW HOOD, FREEZER REPLACEMENT (SINGLE TO DUAL COMPRESSOR), DISTRIBUTION FREEZER TRANSFER TO WAREHOUSE FOR SAMPLE STORAGE, AND AN ADDITION OF A LIQUID NITROGEN STORAGE FREEZER.
P000029|S074|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/25/2013|05/22/2013|||APPR|APPROVAL FOR UPDATE TO THE INFORMATION ABOUT POST-APPROVAL ADVERSE REACTIONS AND UPDATE ON THE LABELING OF THE SPONSOR NAME AND CONTACT INFORMATION.
P110010|S053|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/2013|11/21/2013|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE PROMUS® ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM-CHROMIUM CORONARY STENT SYSTEM: 1)STENT DESIGN MODIFICATIONS TOINCREASE AXIAL STRENGTH; 2) A SHORTER TIP AND COLORANT CHANGE ON THE STENT DELIVERY SYSTEM; 3) MODIFICATIONS TO THE HYPOTUBE COVERING ON THE STENT DELIVERY SYSTEM; AND 4) LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM.
P980016|S415|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR,MAXIMO II,PROTECTA,PROTECTA XT,SECURA,VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2013|05/22/2013|||OK30|SECOND SOURCE SUPPLIER FOR A THICK FILM CHIP RESISTOR.
P010031|S375|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA,CONCERTO II,MAXIMO II,PROTECTA,PROTECTA XT,VIVA S,VIVA XT CRTS,CONSULTA ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2013|05/22/2013|||OK30|SECOND SOURCE SUPPLIER FOR A THICK FILM CHIP RESISTOR.
P970004|S155|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/2013|10/22/2013|||APPR|APPROVAL FOR CHANGES TO THE LABELING AND PRODUCT SPECIFICATION RELATED TO THE USE OF DIAGNOSTIC ULTRASOUND IMAGING TO HELP GUIDE THE INSERTION OF THE FORAMEN NEEDLE INTO ONE OF THE SACRAL FORAMINA DURING THE ACUTE TEST STIMULATION PROCEDURE.
P080025|S051|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/26/2013|10/22/2013|||APPR|APPROVAL FOR CHANGES TO THE LABELING AND PRODUCT SPECIFICATION RELATED TO THE USE OF DIAGNOSTIC ULTRASOUND IMAGING TO HELP GUIDE THE INSERTION OF THE FORAMEN NEEDLE INTO ONE OF THE SACRAL FORAMINA DURING THE ACUTE TEST STIMULATION PROCEDURE.
P060033|S075|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice||N|04/26/2013|10/15/2013|||APPR|APPROVAL FOR A CHANGE TO THE EMPOWER SOFTWARE APPLICATION USED TO CONTROL THE ANALYTICAL CHROMATOGRAPHIC INSTRUMENTS FOR THE ANALYTICAL TESTS.
P110013|S012|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2013|10/15/2013|||APPR|APPROVAL FOR A CHANGE TO THE EMPOWER SOFTWARE APPLICATION USED TO CONTROL THE ANALYTICAL CHROMATOGRAPHIC INSTRUMENTS FOR THE ANALYTICAL TESTS.
P950005|S044|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THERMOCOUPLE, 7F EZ NON-NAV CATHETER W/4MM TIP ELECTRODE AND THERMISTOR|LPB|CV|30-Day Notice||N|04/26/2013|05/29/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
P990025|S037|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|7F EZ STEER DS BI-DIRECTIONAL NAV CATHETER 4MM TIP ELECTRODE AND THERMOCOUPLE|LPB|CV|30-Day Notice||N|04/26/2013|05/29/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
P010068|S034|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|7 FR EZ STEER NAV DS BI-DIRECTIONAL W/ 8MM TIP ELECTRODE W/ DUAL THERMOCOUPLE|OAD|CV|30-Day Notice||N|04/26/2013|05/29/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
P030031|S052|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM, 7F CELCIUS THERMOCOOL CATHETER WITH THERMMISTOR|LPB|CV|30-Day Notice||N|04/26/2013|05/29/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
P040036|S036|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|7.5 FR NAVI-STAR THERMO-COOL VATHETER WITH THERMISTOR|LPB|CV|30-Day Notice||N|04/26/2013|05/29/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
P100010|S025|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER|OAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2013|12/12/2013|||APPR|APPROVAL FOR THE IMPLEMENTATION OF AN ALTERNATIVE PROCEDURE INVOLVING THE INFLATION AND DEFLATION OF BALLOONS CONTAINED IN THE DEVICE DURING THE MANUFACTURING PROCESS.
P030027|S007|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002|0000|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND ARTICULATION SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2013|01/03/2014|||APPR|APPROVAL FOR CHANGING THE INCOMING INSPECTION PROCESS OFCOMPONENTS FROM THE SUPPLIER.
N16837|S011|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT BOVINE HETEROGRAFT|LXA|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2013|12/23/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN NORTH BRUNSWICK, NEW JERSEY.
P900033|S026|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2013|02/05/2015|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGE IN CLEANING DETERGENT FOR CERTAIN EQUIPMENT;2) CHANGE IN CLEANING METHOD FOR CERTAIN EQUIPMENT, UTILIZING ISOPROPYL ALCOHOL;3) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIME (DHT); AND 4) ESTABLISHMENT OF A METHOD TO TEST FOR RESIDUES.
P080027|S011|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2013|05/28/2013|||APPR|APPROVAL OF THE ADDITION OF A VISUAL INSPECTION STEP IN THE ORAQUICK® HCV RAPID ANTIBODY TEST ASSAY CARD MANUFACTURING PROCESS.
P960009|S171|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS LEADS(DEEP BRAIN STIMULATION)|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2013|05/29/2013|||OK30|IMPLEMENT A NEW INSPECTION PROCESS TO VERIFY THE DISTAL END SURFACE STRAIGHTNESS OF THE DBS LEADS.
P950037|S123|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DEXTRUS,ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS,SELOX,SETROX S,SOLOX,TILDA|NVZ|CV|30-Day Notice||N|04/29/2013|05/29/2013|||OK30|A CHANGE IN STERILIZATION LOAD CONFIGURATION; 2) CHANGE IN STERILIZATION PRE-CONDITIONING; 3) STERILIZATION INJECTION PARAMETER CHANGES; AND 4) CHANGE TO THEPROCESS CHALLENGE DEVICE.
P980023|S055|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA|NVY|CV|30-Day Notice||N|04/29/2013|05/29/2013|||OK30|A CHANGE IN STERILIZATION LOAD CONFIGURATION; 2) CHANGE IN STERILIZATION PRE-CONDITIONING; 3) STERILIZATION INJECTION PARAMETER CHANGES; AND 4) CHANGE TO THEPROCESS CHALLENGE DEVICE.
P050023|S065|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ILESTO,IFORIA,LUMAX|MRM|CV|30-Day Notice||N|04/29/2013|05/29/2013|||OK30|A CHANGE IN STERILIZATION LOAD CONFIGURATION; 2) CHANGE IN STERILIZATION PRE-CONDITIONING; 3) STERILIZATION INJECTION PARAMETER CHANGES; AND 4) CHANGE TO THEPROCESS CHALLENGE DEVICE.
P070008|S043|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CELERITY,COROX,ENTOVIS HF(-T),EVIA HF (-T),STRATOS|NKE|CV|30-Day Notice||N|04/29/2013|05/29/2013|||OK30|A CHANGE IN STERILIZATION LOAD CONFIGURATION; 2) CHANGE IN STERILIZATION PRE-CONDITIONING; 3) STERILIZATION INJECTION PARAMETER CHANGES; AND 4) CHANGE TO THEPROCESS CHALLENGE DEVICE.
P990071|S023|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/29/2013|07/17/2013|||APPR|APPROVAL FOR A MINOR SOFTWARE UPDATE FOR SMARTABLATE IRRIGATION PUMP FROM VERSION 1.2 TO 1.3.
P040037|S050|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/29/2013|10/18/2013|||APPR|APPROVAL FOR THE ADDITION OF A 25CM LENGTH FOR THE 5-8MM DIAMETER ENDOPROSTHESES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE AND IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY LESIONS UP TO 230 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 7.5 MM. THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE ARE ALSO INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN ILIAC ARTERY LESIONS UP TO 80 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 12 MM.
P830061|S092|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD,VITATRON CRYSTALINE LEAD,VITATRON EXCELLENCE PS+LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P850089|S097|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P890003|S275|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P920015|S111|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P930039|S088|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE LEAD,VITATRON PIROUET LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P980050|S083|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P950024|S049|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P810002|S085|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTER MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/30/2013|||OK30|CHANGE TO THE CLEAN ROOM FOR THE SJM MECHANICAL HEART VALVES, AND A CHANGE IN THE VAVGJ PACKAGE SEALING PARAMETERS.
P010015|S200|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD,LEFT VENTRICULAR PACING LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P030036|S057|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P060039|S046|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P080006|S053|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P090013|S097|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE.
P850035|S035|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF IMPLANTABLE SPINAL FUSION STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/28/2013|||OK30|ACCEPTANCE OF A REPLACEMENT COIN CELL BATTERY.
P790005|S049|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/28/2013|||OK30|ACCEPTANCE OF A REPLACEMENT COIN CELL BATTERY.
P110013|S013|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|ALTERNATE ANALYTICAL TESTING SUPPLIER.
P060033|S076|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2013|05/29/2013|||OK30|ALTERNATE ANALYTICAL TESTING SUPPLIER.
P950029|S079|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT SR AND DR MODEL PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/30/2013|06/20/2013|||APPR|APPROVAL FOR A MODIFICATION TO THE FLEX CIRCUIT HYBRID COMPONENT AND APPRFOR AN ALTERNATE SUPPLIER.
P990075|S023|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2013|05/15/2013|||OK30|ADD AN ADDITIONAL SUPPLIER OF THE DIAPHRAGM VALVE COMPONENT USED IN THE MANUFACTURE OF THE MENTOR SALINE-FILLED BREAST IMPLANTS.
P100047|S020|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2013|12/20/2013|||APPR|APPROVAL FOR A NEW MONITOR FOR THE HEARTWARE VENTRICULAR ASSIST SYSTEM. THE MONITOR WILL BE MANUFACTURED BY XPLORE TECHNOLOGIES, AUSTIN, TX.
P840062|S025|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE,COLLATAPE,COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2013|11/29/2013|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.
P810006|S036|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2013|11/29/2013|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.
P850010|S033|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2013|11/29/2013|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.
P900033|S027|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2013|11/29/2013|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.
P110035|S013|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2013|05/31/2013|||OK30|ADD IN-PROCESS CONTROLS FOR A COMPONENT BONDING STEP.
P090018|S020|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM SYSTEM|OAF|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2013|06/06/2013|||APPR|APPROVAL FOR ADDITION OF TECHNICAL NOTES TO EXPAND UPON THE INFORMATION IN THE AUDIOLOGISTS MANUAL AND TO REMIND SURGEONS AND AUDIOLOGISTS OF THE IMPORTANCE OF REPORTING SIGNIFICANT INJURIES TO CRANIAL NERVE VII VIA THE MEDICAL DEVICE REPORTING SYSTEM.
P070015|S109|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/30/2013|05/23/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000021|S025|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2013|05/28/2013|||OK30|CHANGE THE SUPPLIER FOR DEXTRAN T110 FROM SIGMA ADRICH FINE CHEMICALS(SAFC) TO PHARMACOMOS AND TO BRING PHTHALOCYANINE MANUFACTURE IN-HOUSE AT THE SIEMENSHEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE SITE AND THE SCALE-UP OF THE SENSIBEAD CONCENTRATE PRODUCTION FROM 150G PER LOT SIZE TO 300G.
P080012|S017|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE IMPLANTABLE PUMP|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/03/2013|05/16/2013|||APPR|APPROVAL FOR AN MRI INFORMATION BRACELET.
P100010|S026|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARTIC FRONT CRYOABLATION CATHETER,ARTIC FRONT ADVANCE CRYOABLATION CATHETER|OAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2013|10/03/2013|||APPR|APPROVAL FOR A NEW PROCESS FOR INCOMING INSPECTION OF CHECK VALVES.
P080026|S007|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2013|05/28/2013|||OK30|CHANGE TO THE SAMPLING PLAN FOR THE REAGENT VIAL FILLING PROCEDURE FOR BOTH DEVICES.
P100017|S006|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2013|05/28/2013|||OK30|CHANGE TO THE SAMPLING PLAN FOR THE REAGENT VIAL FILLING PROCEDURE FOR BOTH DEVICES.
P040002|S041|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/02/2013|06/17/2013|||APPR|APPROVAL FOR THE ADDITION OF A RELEASE SLEEVE TO THE PROXIMAL EXTENSION ACCESSORY STENT GRAFT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX VELA PROXIMAL ENDOGRAFT SYSTEM.
P950022|S086|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA FAMILY OF HIGH VOLTAGE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2013|05/29/2013|||OK30|ADD AN ALTERNATE SUPPLIER OF A LEAD TIP COMPONENT.
P960013|S075|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRILL STS MODEL 2088TC LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2013|05/29/2013|||OK30|ADD AN ALTERNATE SUPPLIER OF A LEAD TIP COMPONENT.
P880086|S233|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY, VERITY, INTEGRITY, VOCTORY, XEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2013|05/30/2013|||OK30|ALTERNATE ASSEMBLY PROCESS FOR ATTACHING THE X-RAY TAG TO THE HYBRID.
P030035|S111|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2013|05/30/2013|||OK30|ALTERNATE ASSEMBLY PROCESS FOR ATTACHING THE X-RAY TAG TO THE HYBRID.
P020027|S020|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2013|05/28/2013|||OK30|CHANGE THE SUPPLIER FOR DEXTRAN T110 FROM SIGMA ADRICH FINE CHEMICALS(SAFC) TO PHARMACOMOS AND TO BRING PHTHALOCYANINE MANUFACTURE IN-HOUSE AT THE SIEMENSHEALTHCARE DIAGNOSTICS, NEWARK, DELAWARE SITE AND THE SCALE-UP OF THE SENSIBEAD CONCENTRATE PRODUCTION FROM 150G PER LOT SIZE TO 300G.
P020045|S047|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYO ABLATION  CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYO ABLATION DEVICE, FREEZOR MAX SURGICAL CARDI|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2013|06/06/2013|||OK30|IMPLEMENTATION OF A SEMI-AUTOMATED STRIP CRIMPER FOR THE WIRES IN THE CABLE.
P030054|S246|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Drug eluting permanent left ventricular (lv) pacemaker electrode|1258T AND 1458Q FAMILY OF LEADS|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2013|11/14/2013|||APPR|APPROVAL FOR A MODIFICATION TO THE WELD SHAFT COMPONENT ON 1258T AND 1458Q LEAD FAMILIES.
P100010|S027|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYO ABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2013|06/06/2013|||OK30|IMPLEMENTATION OF A SEMI-AUTOMATED STRIP CRIMPER FOR THE WIRES IN THE CABLE.
P060040|S027|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II  LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2013|06/03/2013|||OK30|ADDITION OF AN ALTERNATE BURN-IN FIXTURE FOR USE DURING THE MANUFACTURING OF THE HEARTMATE II LVAS PUMPS.
P990081|S019|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|05/06/2013|07/25/2013|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE DISPENSER INWHICH THE PMA REAGENTS IN THE DEVICES ARE STORED AND OR USED, INCLUDING A CHANGE IN THE MATERIALS THE VARIOUS DISPENSER PARTS ARE MADE FROM.
P020055|S008|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|05/06/2013|07/25/2013|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE DISPENSER INWHICH THE PMA REAGENTS IN THE DEVICES ARE STORED AND OR USED, INCLUDING A CHANGE IN THE MATERIALS THE VARIOUS DISPENSER PARTS ARE MADE FROM.
P100027|S009|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|05/06/2013|07/25/2013|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE DISPENSER INWHICH THE PMA REAGENTS IN THE DEVICES ARE STORED AND OR USED, INCLUDING A CHANGE IN THE MATERIALS THE VARIOUS DISPENSER PARTS ARE MADE FROM.
P000025|S069|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2013|05/29/2013|||OK30|ADDITIONAL SUPPLIER OF THE 16-PIN FEEDTHROUGH ASSEMBLY COMPONENT WHICH IS USED IN THE PRODUCTION OF THE MI1000 MED-EL CONCERT COCHLEAR IMPLANTS.
P040037|S051|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2013|06/04/2013|||OK30|CHANGE THE IN-PROCESS COMPONENT INSPECTION ACCEPTANCE CRITERIA FOR THE OUTER LAYER ZIPPER COVERAGE IN THE DEPLOYMENT SYSTEM FOR THE VIABAHN DEVICES.
P030017|S163|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR(SCS)SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2013|06/04/2013|||OK30|ADD AN ALTERNATE WELDER FOR USE IN THE MANUFACTURING PROCESS.
P070026|S014|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/03/2013|07/02/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030017|S164|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM,PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2013|06/04/2013|||OK30|MOVE BEING MADE BY THE TUBING SUPPLIER.
P100049|S006|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/2013|12/19/2013|||APPR|APPROVAL FOR AN UPDATE TO THE LABELING FOR THE LINX DEVICE REGARDING EXPOSURE TO MRI SCANS.
P840001|S240|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRIMEADVANCED SURESCAN MRI IMPLANTABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2013|06/05/2013|||OK30|CHANGES TO IN-PROCESS VISUAL INSPECTIONS.
P100027|S010|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2013|05/29/2013|||OK30|QUALIFICATION OF A NEW SUPPLIER FOR A RAW MATERIAL THAT IS USED IN THE MANUFACTURE OF THE DETECTION KIT ASSOCIATED WITH THE INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL. AS PART OF THIS CHANGE IN RAW MATERIAL, A CHANGE IN THE CELL MEDIA USED TO GROW THE ANTI-DNP ANTIBODY IS ALSO BEING IMPLEMENTED.
P990081|S020|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2013|10/25/2013|||APPR|APPROVAL FOR ADDITION OF A NEW SUPPLIER OF BIOCONJUGATES FOR THE ULTRAVIEW UNIVERSAL DAB DETECTION KIT. THE DETECTION KIT IS PART OF THE PATHWAY ANTI-HER 2/NEU RABBIT MONOCLONAL PRIMARY ANTIBODY (4B5).
P050052|S040|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSSE|LMH|SU|30-Day Notice||N|05/08/2013|05/30/2013|||OK30|ADDITION OF A NEW SYRINGE COMPONENT SUPPLIER.
P040047|S026|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2013|06/07/2013|||OK30|PROPOSED ADDITION OF A NEW SUPPLIER FOR A CRITICAL COMPONENT OF THE SUBJECT DEVICE.
P820003|S121|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|5846 DISPOSABLE PATIENT CABLE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2013|06/06/2013|||OK30|STERILIZATION DOSE PARAMETER CHANGES FOR THE MODELS 5846 A AND  5846 AL AND MODELS 5846 V AND 5846 VL DISPOSABLE PATIENT CABLES.
P110019|S045|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XP|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/08/2013|07/26/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050037|S037|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice||N|05/08/2013|05/30/2013|||OK30|ADDITION OF A NEW SYRINGE COMPONENT SUPPLIER.
P030005|S098|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWWAL TR INVIVE FAMILIES|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2013|06/06/2013|||OK30|ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE EO REMOVAL PHASE.
P010012|S329|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA ENERGEN PUNCTUA COGNIS, LIVIAN FAMILIES|LWP|CV|30-Day Notice||N|05/08/2013|06/06/2013|||OK30|ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE EO REMOVAL PHASE.
P960040|S294|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONFIENT, VIVIAN, INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY FAMILIES.|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2013|06/06/2013|||OK30|ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE EO REMOVAL PHASE.
P010029|S017|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA|MOZ|OR|30-Day Notice||N|05/08/2013|06/04/2013|||OK30|ADD A NEW SYRINGE DENESTER MACHINE AND AN ALTERNATIVE ASSEMBLY AND LABELING MACHINE.
P960011|S023|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BVI 1%OVD|LZP|OP|30-Day Notice||N|05/08/2013|06/04/2013|||OK30|ADD A NEW SYRINGE DENESTER MACHINE AND AN ALTERNATIVE ASSEMBLY AND LABELING MACHINE.
P000012|S041|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|06/06/2013|||OK30|ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE COBAS AMPLIPREP INSTRUMENT.
P050028|S032|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST,V2.0|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|06/06/2013|||OK30|ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE COBAS AMPLIPREP INSTRUMENT.
P060030|S032|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|06/06/2013|||OK30|ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE COBAS AMPLIPREP INSTRUMENT.
P110037|S006|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBRA TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|06/06/2013|||OK30|ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE COBAS AMPLIPREP INSTRUMENT.
P060002|S032|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|05/29/2013|||OK30|UPDATE THE BOND PEEL INSPECTION.
P110035|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|06/06/2013|||OK30|VENDOR LOCATION CHANGE.
P930031|S043|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT ENDOPROSTHESIS TIPS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|06/06/2013|||OK30|VENDOR LOCATION CHANGE.
P940019|S037|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT ENDOPROSTHESIS ILIAC|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|06/06/2013|||OK30|VENDOR LOCATION CHANGE.
P980033|S032|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDOPROSTHESIS VENOUS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2013|06/06/2013|||OK30|VENDOR LOCATION CHANGE.
P910023|S315|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ELLIPSE FAMILY OF ICDS|NVZ|CV|30-Day Notice||N|05/09/2013|06/06/2013|||OK30|MODIFICATIONS TO THE IS-1 SPRING INSTALLATION PROCEDURE, THE ADDITION OF A VISUALINSPECTION OF THE SPRING, AND THE ADDITION OF AN INTERNAL THREADING INSPECTION.
P110010|S054|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2013|09/27/2013|||APPR|APPROVAL FOR UPDATES TO THE SOFTWARE AND HARDWARE OF THE BALLOON MOLDING TOWERS.
P980035|S324|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2013|06/06/2013|||OK30|REMOVAL OF SWAB TEST FOR THE DEVICES.
P890003|S276|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2013|06/06/2013|||OK30|REMOVAL OF SWAB TEST FOR THE DEVICES.
P910023|S316|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FORTIFY AND PROMOTE QUANDRA FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/12/2013|||OK30|ST. JUDE MEDICAL CRMDSYLMAR CA 91342	MODIFICATION OF THE HYBRID POST BURN-IN ATE TESTING FOR THE DEVICES.
P030054|S248|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY AND UNIFY QUANDRA FAMILY OF CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/12/2013|||OK30|ST. JUDE MEDICAL CRMDSYLMAR CA 91342	MODIFICATION OF THE HYBRID POST BURN-IN ATE TESTING FOR THE DEVICES.
P910023|S318|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICDS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/12/2013|||OK30|MODIFICATION OF AUX CONVERTER ATE TESTING FOR THE DEVICES.
P030054|S250|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/12/2013|||OK30|MODIFICATION OF AUX CONVERTER ATE TESTING FOR THE DEVICES.
P910023|S319|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILIES OF ICD DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/11/2013|||OK30|ADDITION OF A BARRIER LAYER FOR THE FINAL FINISH OF HYBRID SUBSTRATES.
P030054|S251|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE+, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMI LIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/11/2013|||OK30|ADDITION OF A BARRIER LAYER FOR THE FINAL FINISH OF HYBRID SUBSTRATES.
P100010|S028|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARTIC FRONT CRYOABLATION CATHETER,ARTIC FRONT ADAVNCE CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/12/2013|||OK30|RESEQUENCING OF MANUFACTURING STEPS USED IN THE MANUFACTURE OF THE ARCTIC FRONT AND ARCTIC FRONT ADVANCE CATHETERS.
P080011|S024|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY XR|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/13/2013|07/16/2013|||APPR|APPROVAL TO ADD THE NEW BRAND NAME BIOFINITY XR.
P120008|S003|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP,LN 3P36|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/12/2013|||OK30|CHANGE FOR THE ADDITION OF A QUALITY CONTROL TEST FOR PROTEIN PURITY OF INCOMING RAW MATERIAL (ALBUMIN BOVINE 30% SOLUTION WITH 0.1% SODIUM AZIDE (BOVINE ALBUMIN SOLUTION) USED IN THE MANUFACTURING OF CONTROLS AND CALIBRATORS FOR THE ARCHITECT AFP ASSAY. DUE TO THE RAW MATERIAL DISTRIBUTOR NOT HAVING A VALIDATED QUALITY CONTROL TEST FOR PROTEIN PURITY, THE ADDITIONAL QUALITY CONTROL TEST WILL BE IMPLEMENTED TO ENSURE THE PROTEIN PURITY OF THE RAW MATERIAL MEETS THE MANUFACTURERS SPECIFICATIONS.
P100047|S021|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/13/2013|08/30/2013|||APPR|APPROVAL TO MODIFY THE OUTER DIAMETER AND THICKNESS OF THE PUMPS DRIVELINE SHEATH TUBING.
P900033|S028|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2013|06/03/2013|||OK30|CHANGE IN BIOBURDEN TEST METHOD AND A NEW TESTING LABORATORY.
P840062|S026|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2013|06/03/2013|||OK30|CHANGE IN BIOBURDEN TEST METHOD AND A NEW TESTING LABORATORY.
P810006|S037|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLEGEN HEMOSTATIC SPONGE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2013|06/03/2013|||OK30|CHANGE IN BIOBURDEN TEST METHOD AND A NEW TESTING LABORATORY.
P850010|S034|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2013|06/03/2013|||OK30|CHANGE IN BIOBURDEN TEST METHOD AND A NEW TESTING LABORATORY.
P040038|S029|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2013|06/11/2013|||OK30|CHANGE TO THE PYROGEN SAMPLING PLAN.
P070015|S110|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORNARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2013|06/11/2013|||OK30|CHANGE TO THE PYROGEN SAMPLING PLAN.
P110019|S046|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONORY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2013|06/11/2013|||OK30|CHANGE TO THE PYROGEN SAMPLING PLAN.
P890003|S277|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITORS, CARELINK EXPRESS MONITIORS, CARDIOSIGHT READERS, REVEAL DX, REVEAL XT|NVZ|CV|Real-Time Process||N|05/13/2013|07/15/2013|||APPR|APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
P010031|S376|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S|NIK|CV|Real-Time Process||N|05/13/2013|07/15/2013|||APPR|APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
P090013|S098|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process||N|05/13/2013|07/15/2013|||APPR|APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
P010015|S201|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|Real-Time Process||N|05/13/2013|07/15/2013|||APPR|APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
P980035|S325|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA, ENRHYTHM MRI|NVZ|CV|Real-Time Process||N|05/13/2013|07/15/2013|||APPR|APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
P980016|S416|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO DR,VIRTUOSO VR,SECURA DR, MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR|LWS|CV|Real-Time Process||N|05/13/2013|07/15/2013|||APPR|APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
P100046|S002|ATRICURE INC.|386 WEST MAIN STREET, SUITE 7||NORTHBOROUGH|MA|01532||Surgical cardiac ablation device, for treatment of atrial fibrillation|ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB|OCM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2013|06/14/2013|||OK30|ADDITION OF A VISUAL INSPECTION FOR PROXIMAL WELD LENGTH FOR THE DEVICES, MODIFICATIONS RELATING TO THE LASER WELDER FOR DISTAL AND PROXIMAL JAW WELDMENTS AND THE ADDITION OF A RE-WELDING PROCESS FOR THE OLL2 AND OSL2 PROXIMAL AND DISTAL WELDMENTS.
P840062|S027|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2013|06/10/2013|||OK30|IMPLEMENTATION OF SAMPLING PLAN ANALYZER SOFTWARE.
P120007|S001|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV  16  18/45 GENOTYPE ASSAY|OYB|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/15/2013|11/06/2013|||APPR|APPROVAL FOR THE ADDITION OF THE PANTHER SYSTEM TO THE APTIMA® HPV 16 18/45 GENOTYPE ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV 16 18/45 GENOTYPE ASSAY. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) OF HUMAN PAPILLOMAVIRUS (HPV) TYPES 16, 18, AND 45 IN CERVICAL SPECIMENS FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN DIFFERENTIATE HPV 16 FROM HPV 18 AND/OR HPV 45, BUT DOES NOT DIFFERENTIATE BETWEEN HPV 18 AND HPV 45. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV 16 18/45 GENOTYPE ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM.  FOR FURTHER INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
P980040|S043|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOL)|HQL|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/15/2013|06/11/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P810006|S038|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2013|06/10/2013|||OK30|IMPLEMENTATION OF SAMPLING PLAN ANALYZER SOFTWARE.
P850010|S035|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2013|06/10/2013|||OK30|IMPLEMENTATION OF SAMPLING PLAN ANALYZER SOFTWARE.
P900033|S029|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2013|06/10/2013|||OK30|IMPLEMENTATION OF SAMPLING PLAN ANALYZER SOFTWARE.
P980040|S044|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS)|HQL|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/15/2013|04/14/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S108|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|Special (Immediate Track)||N|05/16/2013|06/10/2013|||APPR|APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.
P100041|S028|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM|NPT|CV|Special (Immediate Track)||N|05/16/2013|06/10/2013|||APPR|APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.
P110021|S014|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM|NPT|CV|Special (Immediate Track)||N|05/16/2013|06/10/2013|||APPR|APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.
P050034|S009|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X|NCJ|OP|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|05/15/2013|11/05/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE APPROVED PROFESSIONAL USE INFORMATION AND PATIENT INFORMATION BOOKLET TO ADD INFORMATION OBTAINED FROM POST-APPROVAL STUDY IMT-002-LTME.
P980035|S327|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P890003|S278|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P980035|S326|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2013|07/17/2013|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE L386 INTEGRATED CIRCUIT AND ASSOCIATED MINOR MANUFACTURING CHANGES.
P870072|S054|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD)|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/16/2013|10/11/2013|||APPR|APPROVAL FOR A NEW CAR POWER ADAPTER FOR THE TLC II PORTABLE VAD DRIVER.
P840062|S028|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2013|06/18/2013|||OK30|CHANGES IN CLEANING DETERGENT, DIRTY EQUIPMENT HOLD TIMES, AND CLEANING METHODS.
P830060|S075|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2013|08/07/2013|||APPR|APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.
P810006|S039|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2013|06/18/2013|||OK30|CHANGES IN CLEANING DETERGENT, DIRTY EQUIPMENT HOLD TIMES, AND CLEANING METHODS.
P910073|S117|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD FAMILY|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2013|08/07/2013|||APPR|APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.
P850010|S036|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT FIBULLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2013|06/18/2013|||OK30|CHANGES IN CLEANING DETERGENT, DIRTY EQUIPMENT HOLD TIMES, AND CLEANING METHODS.
P910077|S133|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX MINI|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2013|08/07/2013|||APPR|APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.
P960004|S061|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINLINE LEAD FAMILY|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2013|08/07/2013|||APPR|APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.
P960006|S039|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX/ FLEXTEND LEAD FAMILY|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/16/2013|08/07/2013|||APPR|APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.
P100034|S005|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVA TTF-100A SYSTEM|NZK|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2013|06/12/2013|||OK30|MANUFACTURING CHANGE TO THE INE TRANSDUCER ARRAY CABLE AND FLEXIBLE PRINTED CIRCUIT BOARD (PCB) OF THE DEVICE.
P980050|S084|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE LEAD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P980016|S417|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, S VR ICD,XT DR ICD, XT VR ICD, INTRINISIC ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, MAXIMO II ICD; VR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P990001|S112|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG , C60 DR IPG, T20 SR IPG, VITATRON T60 DR IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P950024|S050|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P920015|S113|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR POT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-I CONNECTOR PORT PIN PLUG KIT,|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P900061|S122|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P850089|S098|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P010015|S202|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING  LEAD|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P830061|S093|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ADHESIVE, CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELENCE PS+LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P930039|S089|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P060039|S047|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P080006|S054|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P090013|S099|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD, REVO MRI IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P010031|S377|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICDM INSYNC III MARQUIS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P030036|S058|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/17/2013|07/23/2013|||APPR|APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
P980016|S418|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2013|06/14/2013|||OK30|USE THE CHEMICAL VERIFICATION TRACEABILITY (CTS) SYSTEM AT MTC HYBRID MANUFACTURING.
P010015|S203|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2013|06/14/2013|||OK30|USE THE CHEMICAL VERIFICATION TRACEABILITY (CTS) SYSTEM AT MTC HYBRID MANUFACTURING.
P040037|S052|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2013|06/14/2013|||OK30|CHANGE THE PRESSURE PARAMETER FOR THE PACKAGE SEALING EQUIPMENT FOR THE DEVICE.
P010031|S378|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2013|06/14/2013|||OK30|USE THE CHEMICAL VERIFICATION TRACEABILITY (CTS) SYSTEM AT MTC HYBRID MANUFACTURING.
P090013|S100|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRT IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2013|06/14/2013|||OK30|USE THE CHEMICAL VERIFICATION TRACEABILITY (CTS) SYSTEM AT MTC HYBRID MANUFACTURING.
P980035|S328|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2013|06/14/2013|||OK30|USE THE CHEMICAL VERIFICATION TRACEABILITY (CTS) SYSTEM AT MTC HYBRID MANUFACTURING.
P070015|S111|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CONONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2013|09/23/2013|||APPR|APPROVAL FOR THE DISCONTINUATION OF THE MOLECULAR WEIGHT AND POLYDISPERSITY TESTS FROM THE ANNUAL STABILITY TESTING.
P910077|S134|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ZOOM LATITUDE PROGRAMMING SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/17/2013|06/20/2013|||APPR|APPROVAL FOR USE OF AN ALTERNATE ANTENNA (MODEL 3123) WITH THE LATITUDE PROGRAMMER/RECORDER/MONITOR MODEL 3120 AND ASSOCIATED DEVICE LABELING.
P850010|S037|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/18/2013|||OK30|CHANGE IN THE CLEAN HOLD TIME AFTER THE CLEANING PROCESS OF TRAYS.
P120005|S005|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2013|08/14/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE G4 PLATINUM FIRMWARE FOR THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM TO INCLUDE CODE REVISIONS AND FIRMWARE CHANGES TO IMPROVE COMMUNICATIONS, UPDATES TO THE FLASH MEMORY AND THE USB, PLUS A SINGLE CHANGE TO A DOCUMENTATION REVISION IN THE SOFTWARE REQUIREMENTS SPECIFICATION BUT NO CHANGES TO THE CODE WERE PERFORMED.
P040037|S053|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice||N|05/20/2013|06/17/2013|||OK30|ADD AN ALTERNATE SUPPLIER FOR RAW HEPARIN SODIUM.
P830055|S134|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/11/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS ISOMEDIX, CHESTER, NEW YORK, TO PERFORM STERILIZATION OPERATIONS FOR THE LCS TOTAL KNEE SYSTEM.
P010032|S071|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS ACCESSORY KIT|LGW|NE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|08/15/2013|||APPR|APPROVAL FOR A NEW TRAY DESIGN FOR THE SCS ACCESSORY KIT USED WITH ST. JUDE MEDICALS NEUROSTIMULATION SYSTEMS.
P020056|S020|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/12/2013|||OK30|ALLERGAN COSTA RICA FACILITY ADD MANUFACTURING SPACE (FLOOR SPACE) TO ITS PRODUCTION AREA IN THE SHELL SOAKING AND SCRUBBING ROOM (ROOM 2) AND GOWNING ROOM (ROOM 3) AND NEW HEPA FILTERS TO ROOM 2.
P850010|S038|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/18/2013|||OK30|ADDITION OF A NEW FREEZE DRYER.
P030017|S166|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/19/2013|||OK30|CHANGE THE STERILIZATION METHOD.
P040046|S002|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/12/2013|||OK30|ALLERGAN COSTA RICA FACILITY ADD MANUFACTURING SPACE (FLOOR SPACE) TO ITS PRODUCTION AREA IN THE SHELL SOAKING AND SCRUBBING ROOM (ROOM 2) AND GOWNING ROOM (ROOM 3) AND NEW HEPA FILTERS TO ROOM 2.
P990074|S026|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/12/2013|||OK30|ALLERGAN COSTA RICA FACILITY ADD MANUFACTURING SPACE (FLOOR SPACE) TO ITS PRODUCTION AREA IN THE SHELL SOAKING AND SCRUBBING ROOM (ROOM 2) AND GOWNING ROOM (ROOM 3) AND NEW HEPA FILTERS TO ROOM 2.
P110032|S003|LOMBARD MEDICAL TECHNOLOGIES INC|15420 LAGUNA CANYON ROAD|SUITE 260|IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AORFIX AA FLEXIBLE STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/18/2013|||OK30|MODIFIED STERILIZATION CYCLE.
P950037|S124|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|RENAMIC|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2013|07/12/2013|||APPR|APPROVAL OF THE INTRODUCTION OF A PACING SYSTEM ANALYZER (PSA)MODULE TO THE RENAMIC PROGRAMMER, AS WELL AS AN UPDATED DISPLAY SCREEN AND ASSOCIATED LABELING UPDATES.
P030017|S165|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2013|06/19/2013|||OK30|UPDATE THE TEST SOFTWARE FOR THE REMOTE CONTROL.
P990009|S036|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2013|06/19/2013|||APPR|APPROVAL FOR INCLUSION OF AN ADDITIONAL PRECAUTION STATEMENT IN THE INSTRUCTIONS FOR USE FOR THE FLOSEAL HEMOSTATIC MATRIX ('FLOSEAL').
P080006|S055|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P830061|S094|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCLLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P010031|S379|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P850089|S099|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P980035|S329|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P030036|S059|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|LEAD ANCHORING SLEEVE KIT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P930039|S090|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P020004|S082|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|05/21/2013|06/21/2013|||OK30|NEW, AUTOMATED, PRE-LAMINATION WRAPPER MACHINE.
P980016|S419|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR, ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P040043|S053|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|05/21/2013|06/21/2013|||OK30|NEW, AUTOMATED, PRE-LAMINATION WRAPPER MACHINE.
P840062|S029|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, AND COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/20/2013|||OK30|IMPLEMENTATION OF A REPLACEMENT PORTABLE CHILLER.
P810006|S040|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/20/2013|||OK30|IMPLEMENTATION OF A REPLACEMENT PORTABLE CHILLER.
P850010|S039|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT AND HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/20/2013|||OK30|IMPLEMENTATION OF A REPLACEMENT PORTABLE CHILLER.
P030017|S167|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/20/2013|||OK30|UTILIZATION OF AN ALTERNATE WELDING SYSTEM FOR USE IN THE MANUFACTURING PROCESS.
P010015|S204|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|CONSULTA CRT-P, SYNCRA CRT-P|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|ALTERNATE SUPPLIERS FOR THE MANUFACTURE OF MULTIPLE SILICONE COMPONENTS.
P950032|S073|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/25/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN CANTON, MASSACHUSETTS.
P900056|S122|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/19/2013|||OK30|CHANGES TO THE EQUIPMENT USED FOR THE PRESSING, BONDING AND FIBER OPTIC CRIMPING AND TRIMMING OPERATIONS FOR THE ROTALINK ADVANCER AND CATHETER WHICH ARE PART OF THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM.
P000012|S042|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/07/2013|||OK30|CHANGE TO UPDATE THE SPECIFICATIONS FOR RECEIVING ACCEPTANCE OF A SUPPLIER¿S MATERIAL USED IN THE DEVICE.
P020056|S021|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2013|06/20/2013|||OK30|ADDITIONAL DRY HEAT STERILIZERS FOR PROCESSING SILICONE-FILLED BREAST IMPLANTS.
P040046|S003|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2013|06/20/2013|||OK30|ADDITIONAL DRY HEAT STERILIZERS FOR PROCESSING SILICONE-FILLED BREAST IMPLANTS.
P030017|S168|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2013|08/06/2013|||APPR|APPROVAL FOR A CHANGE OF THE OUTER BOX USED AS SECONDARY PACKAGINGFOR THE PRECISION SPECTRA IMPLANTED PULSE GENERATOR, AND THE SPECTRA OPERATING ROOM CABLE/EXTENSION KITS.
P810006|S041|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2013|06/19/2013|||OK30|MODIFICATIONS TO A FINISHED GOODS ACCEPTANCE TEST FOR COLLAGEN AND QUALIFICATION OF ASSOCIATED PROCESS EQUIPMENT.
P850010|S040|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2013|06/19/2013|||OK30|MODIFICATIONS TO A FINISHED GOODS ACCEPTANCE TEST FOR COLLAGEN AND QUALIFICATION OF ASSOCIATED PROCESS EQUIPMENT.
P110019|S047|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, SV|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/22/2013|04/23/2014|||APPR|APPROVAL FOR AN UPDATE TO THE LABELING FOR THE XIENCE XPEDITION RX (RAPID EXCHANGE) AND OTW (OVER-THE-WIRE) TO CHANGE THE GUIDING CATHETER COMPATIBILITY FOR THE 4.0MM BALLOON DIAMETER SIZES FROM A MINIMUM OF A 6 FRENCH (F) GUIDE CATHETER TO 5F FOR THE 4.0 X 8-33MM SIZES.
P030005|S099|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE,INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P)|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2013|07/25/2013|||APPR|APPROVAL FOR MODEL 2869 ZOOMVIEW PROGRAMMER SOFTWARE APPLICATION V1.09 AND INGENIO FIRMWARE VERSION D_V1.02 WITH PATCH V1.01 FOR THE DEVICES.
P080030|S009|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2013|06/20/2013|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER OF STEARALKONIUM HEPARIN.
P910077|S135|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE COMMUNICATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2013|06/20/2013|||OK30|ALTERNATE SURFACE MOUNT TECHNOLOGY (SMT) LINE FOR PRODUCTION OF PRINTED CIRCUIT BOARD ASSEMBLIES.
P060037|S022|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXT GEN LPS -FLEX MOBILE AND LPS-MOBILE BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2013|06/21/2013|||OK30|CHANGE TO THE CNC MACHINE COOLANT.
P960040|S295|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, INCEEPTA, ENERGEN, PUNCTUA, TELIGEN , ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2013|06/21/2013|||OK30|ADDITION OF TWO NEW MOSFET ACCEPTANCE TEST CASES FOR THE ABOVE REFERENCEDDEVICES.
P060006|S046|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2013|06/21/2013|||OK30|SOFTWARE MODIFICATIONS TO THE BALLOON STRETCHING PROCESS.
P010012|S330|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS, INC EPTA, ENERGEN, PUNCTUA, C OGNIS CRT-D'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2013|06/21/2013|||OK30|ADDITION OF TWO NEW MOSFET ACCEPTANCE TEST CASES FOR THE ABOVE REFERENCEDDEVICES.
P810006|S042|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT/INSTAT MCH ABSORBABLE COLLAGEN HEMOSTATIC AGENT-FIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2013|06/20/2013|||OK30|QUALIFICATION OF A HEAT SEAL MACHINE.
P980040|S045|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||SENSAR ACRYLIC IOL, TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL||OP|30-Day Notice||N|05/24/2013|06/18/2013|||OK30|NEW TEST METHOD VALIDATION FOR THE ULTRA HIGH PERFORMANCE LIQUIDCHROMATOGRAPHY (UHPLC) SYSTEM.
P990080|S038|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC IOL|HQL|OP|30-Day Notice||N|05/24/2013|06/18/2013|||OK30|NEW TEST METHOD VALIDATION FOR THE ULTRA HIGH PERFORMANCE LIQUIDCHROMATOGRAPHY (UHPLC) SYSTEM.
P080010|S009|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL 3-PIECE IOL|MFK|OP|30-Day Notice||N|05/24/2013|06/18/2013|||OK30|NEW TEST METHOD VALIDATION FOR THE ULTRA HIGH PERFORMANCE LIQUIDCHROMATOGRAPHY (UHPLC) SYSTEM.
P960028|S037|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL IOL|MFK|OP|30-Day Notice||N|05/24/2013|06/18/2013|||OK30|NEW TEST METHOD VALIDATION FOR THE ULTRA HIGH PERFORMANCE LIQUIDCHROMATOGRAPHY (UHPLC) SYSTEM.
P020045|S048|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR, FREEZOR XTRA AND FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2013|06/21/2013|||OK30|IMPLEMENTATION OF A NEW TEST APPARATUS FOR INCOMING INSPECTION OF THE AUTOMATIC SWITCH CONNECTION BOX COMPONENT.
P000012|S043|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/24/2013|||OK30|CHANGE TO THE BULK TESTING REQUIREMENTS FOR POSITIVE CONTROL REAGENTS.
P050028|S033|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/24/2013|||OK30|CHANGE TO THE BULK TESTING REQUIREMENTS FOR POSITIVE CONTROL REAGENTS.
P940019|S038|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT LLIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/26/2013|||OK30|CHANGE TO THE BRAIDING INSPECTION PROCESS.
P930031|S044|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/26/2013|||OK30|CHANGE TO THE BRAIDING INSPECTION PROCESS.
P980033|S033|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROSTHESIS UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/26/2013|||OK30|CHANGE TO THE BRAIDING INSPECTION PROCESS.
P050019|S014|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID EALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/26/2013|||OK30|CHANGE TO THE BRAIDING INSPECTION PROCESS.
P110019|S048|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2013|06/02/2014|||APPR|APPROVAL TO MODIFY THE IN VITRO DRUG RELEASE SPECIFICATIONS FOR THE DEVICES.
P810002|S086|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/28/2013|||OK30|CHANGE IN DIMENSIONAL INSPECTION EQUIPMENT USED TO INSPECT LEAFLETS USED INTHE ST. JUDE MEDICAL MECHANICAL HEART VALVES.
P930016|S038|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|WAVESCAN WAVEFRONT SYSTEM|LZS|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/2013|06/27/2013|||APPR|APPROVAL FOR CHANGES TO THE WAVESCAN WAVEFRONT SYSTEM DEVICE LABELING (USER MANUAL).
P910073|S118|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE IS-1/DF-1,RELIANCE 4-SITE PASSIVE FIXATION LEADS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/28/2013|07/16/2013|||APPR|APPROVAL FOR AN ALTERNATE PRIMER MATERIAL FOR THE PASSIVE FIXATIONRELIANCE IS-1/4-SITE LEADS.
P100021|S026|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM,ENDURANT II STENT GRAFT SYSTEM,ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/25/2013|||OK30|CHANGE TO THE WATER SOLUBLE ADDITIVE THAT IS USED DURING THE LASER CUTTINGPROCESS.
P840062|S030|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG, ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/26/2013|||OK30|REPLACEMENT OF AIR HANDLING UNITS.
P810006|S043|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/26/2013|||OK30|REPLACEMENT OF AIR HANDLING UNITS.
N17600|S027|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE ULTRAFOAM MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/27/2013|||OK30|REVISED LAL (ENDOTOXIN) TEST FOR THE AVITENE® ULTRAFOAM® MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE MANUFACTURED AT THE WOBURN MASSACHUSETTS SITE.
P850010|S041|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/26/2013|||OK30|REPLACEMENT OF AIR HANDLING UNITS.
P900033|S030|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/26/2013|||OK30|REPLACEMENT OF AIR HANDLING UNITS.
P110007|S005|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD),(3% SODIUM HYALURONATE)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/27/2013|||OK30|CONVERSION OF AN EXISTING CLEAN ROOM SPACE INTO AN ADDITIONAL FORMULATION ROOM FOR THE USE IN THE PRODUCTION OF THE HEALON ENDOCOAT OVD.
P810031|S048|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD),HEALON,HEALONGV,AND HEALON5 PRODUCTS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/27/2013|||OK30|CONVERSION OF AN EXISTING CLEAN ROOM SPACE INTO AN ADDITIONAL FORMULATION ROOM FOR THE USE IN THE PRODUCTION OF THE HEALON ENDOCOAT OVD.
P100041|S029|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/25/2013|||OK30|CHANGE TO THE SILICONE GASKET MATERIAL (SUPPLIED BY SAINT GOBAIN) FOR THE 3.8 OZ.JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR THE EDWARDS SAPIEN VALVE.
P110021|S015|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|06/25/2013|||OK30|CHANGE TO THE SILICONE GASKET MATERIAL (SUPPLIED BY SAINT GOBAIN) FOR THE 3.8 OZ.JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR THE EDWARDS SAPIEN VALVE.
P040024|S070|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/28/2013|11/14/2014|||APPR|APPROVAL FOR NEW SUPPLIER OF RAW HYALURONIC ACID (I.E., HTL BIOTECHNOLOGYS.A.S., FRANCE).
P110013|S014|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|07/10/2013|||OK30|UPGRADE TO THE SPRAY WEIGH AUTOMATED SYSTEM (SWAT III) AND SPRAYER CURRENTLY USED ON THE RESOLUTE INTEGRITY AND ENDEAVOR SPRINT DEVICES.
P060033|S077|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|07/10/2013|||OK30|UPGRADE TO THE SPRAY WEIGH AUTOMATED SYSTEM (SWAT III) AND SPRAYER CURRENTLY USED ON THE RESOLUTE INTEGRITY AND ENDEAVOR SPRINT DEVICES.
P980035|S330|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG,ENRHYTHM IPG,SIGMA DR AND SIGMA S IPG,ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/26/2013|||OK30|ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.
P010031|S380|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/26/2013|||OK30|ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.
P090013|S102|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/26/2013|||OK30|ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.
P990001|S113|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/26/2013|||OK30|ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.
P100029|S015|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2013|05/08/2014|||APPR|APPROVAL FOR AN ALTERNATE BACTERIAL ENDOTOXIN SAMPLING/TESTING PLAN FOR THE TRIFECTA VALVE.
P040025|S013|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL CAP|MXM|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/28/2013|08/29/2013|||APPR|APPROVAL FOR A SOFTWARE PATCH THAT ALLOWS THE WATCHDOG TIMER TO REBOOT THE DEVICE AND INITIATE A POWER FAILURE RECOVERY ALARM IN THE EVENT OF A SCREEN FREEZE CONDITION.
P860057|S109|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AORTIC BIOPROSTHESIS, RSR PERICARDIAL|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/25/2013|||OK30|CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.
P870056|S059|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, MITRAL BIOPROSTHESIS,; BIOPROSTHESIS  VALVED CONDUIT; DURAFLEX LOW PRES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/25/2013|||OK30|CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.
P870077|S054|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS; BIOPROSTHESIS-EDWARDS DURAFLEX LOW PRESSURE MITRA|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/25/2013|||OK30|CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.
P010015|S205|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES|NKE|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|05/29/2013|04/10/2014|14M-0553|05/08/2014|APPR|APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF THE CRT-P AND CRT-D DEVICES TO INCLUDE NYHA FUNCTIONAL CLASS I, II, OR III PATIENTS WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION (LVEF) => 50% ARE ON STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED, AND HAVE ATRIOVENTRICULAR BLOCK (AV BLOCK) THAT IS EXPECTED TO REQUIRE A HIGH PERCENTAGE OF VENTRICULAR PACING THAT CANNOT BE MANAGED WITH ALGORITHMS TO MINIMIZE RIGHT VENTRICULAR PACING.  THESE DEVICES ARE INDICATED FOR THE FOLLOWING:  THE CONSULTA CRT-P SYSTEM IS INDICATED FOR: 1)  NYHA FUNCTIONAL CLASS III AND IV PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY AND HAVE A LVEF =< 35%  AND A PROLONGED QRS DURATION; AND 2) NYHA FUNCTIONAL CLASS I, II, OR III PATIENTS WHO HAVE A LVEF  =<50% ARE ON STABLE OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED AND HAVE ATRIOVENTRICULAR BLOCK (AV BLOCK) THAT ARE EXPECTED TO REQUIRE A HIGH PERCENTAGE OF VENTRICULAR PACING THAT CANNOT BE MANAGED WITH ALGORITHMS TO MINIMIZE RIGHT VENTRICULAR PACING.   FOR ADDITIONAL INFORMATION PLEASE REFER TO APPROVAL ORDER.
P000007|S041|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/25/2013|||OK30|CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.
P010031|S381|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES|NIK|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|05/29/2013|04/10/2014|14M-0553|05/08/2014|APPR|APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF THE CRT-P AND CRT-D DEVICES TO INCLUDE NYHA FUNCTIONAL CLASS I, II, OR III PATIENTS WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION (LVEF) =< 50% ARE ON STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED, AND HAVE ATRIOVENTRICULAR BLOCK (AV BLOCK) THAT IS EXPECTED TO REQUIRE A HIGH PERCENTAGE OF VENTRICULAR PACING THAT CANNOT BE MANAGED WITH ALGORITHMS TO MINIMIZE RIGHT VENTRICULAR PACING. THESE DEVICES ARE INDICATED FOR THE CONSULTA CRT-D MODEL D224TRK, CONCERTO II CRT-D MODEL D274TRK, CONSULTA CRT-D MODEL D204TRM, PROTECTA XT CRT-D MODEL D314TRM, PROTECTA CRT-D MODEL D334TRM, PROTECTA XT CRT-D MODEL D314TRG, PROTECTA CRT-D MODEL D334TRG, VIVA XT CRT-D MODEL DTBA1D4, VIVA XT CRT-D MODEL DTBA1D1, VIVA S CRT-D MODEL DTBB1D4, AND VIVA S CRT-D MODEL DTBB1D1:  FOR ADDITIONAL INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
P010041|S043|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/25/2013|||OK30|CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.
P980016|S420|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD,SECUR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/26/2013|||OK30|ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.
P090018|S021|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/25/2013|||OK30|CHANGES TO THE LEAD MANUFACTURING PROCESS.
P100041|S030|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/25/2013|||OK30|CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.
P110021|S016|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2013|06/25/2013|||OK30|CLEAN ROOM MODIFICATIONS AT EDWARDS IRVINE HEART VALVECENTER FACILITY, TISSUE ISOLATION ROOM, ROOM 153.
P980035|S331|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,ADAPTAL,ADAPTA S,SENSIA L,SENSIA,VERSA IPG,RELIA IPG,SIGMA DR IPG,SIGMA S IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2013|06/27/2013|||OK30|MODIFICATION TO THE BATTERY IODINE FILL STATIONS FOR SELECTED LOW POWER BATTERIES.
P990001|S114|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2013|06/27/2013|||OK30|MODIFICATION TO THE BATTERY IODINE FILL STATIONS FOR SELECTED LOW POWER BATTERIES.
P890003|S279|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2013|06/27/2013|||OK30|MODIFICATION TO THE BATTERY IODINE FILL STATIONS FOR SELECTED LOW POWER BATTERIES.
P840001|S241|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X 8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY, SCS SCREENING TRAIL|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2013|12/11/2013|||APPR|APPROVAL FOR CHANGE TO AN AUTOMATED DESTRUCTIVE TEST ANALYSIS PROCESS.
P100003|S002|GLOBUS MEDICAL INC.|2560 GENERAL ARMISTEAD AVE.||AUDUBON|PA|19403||PROSTHESIS, INTERVERTEBRAL DISC|SECURE-C CERVICAL ARTIFICIAL DISC|MJO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2013|09/06/2013|||APPR|APPROVAL FOR ADDITIONAL DEVICE-SPECIFIC INSTRUMENTATION ASSOCIATED WITH THE SECURE®-C CERVICAL ARTIFICIAL DISC.
P050038|S018|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2013|06/18/2013|||OK30|CHANGE IN PACKAGING PROCESS.
P040002|S042|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2013|08/26/2013|||APPR|APPROVAL FOR THE ADDITION OF NEW GUIDEWIRE SUBASSEMBLY PROVIDED BY ACME MONACO.
P940015|S027|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC AND SYNVISC-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2013|06/28/2013|||OK30|INCREASE IN EXTRACT PRODUCTION.
P100047|S022|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/31/2013|07/03/2013|||APPR|APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE WARNINGS AND INFORMATION RELATED TO ELECTROSTATIC DISCHARGE EXPOSURE AND EXCHANGING POWER SOURCES.
P070015|S112|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V EECSS,XIENCE V)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2013|06/27/2013|||OK30|CHANGE TO THE APHA COLOR TEST METHOD FOR A SOLVENT USED IN THE MANUFACTURING OF AV¿S DEVICE-DRUG COMBINATION PRODUCTS.
P110019|S049|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EECSS (XIENCE PRIME AND XIENCE PRIME LONG LENGTHS [LL])|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2013|06/27/2013|||OK30|CHANGE TO THE APHA COLOR TEST METHOD FOR A SOLVENT USED IN THE MANUFACTURING OF AV¿S DEVICE-DRUG COMBINATION PRODUCTS.
P960009|S172|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS EXTENSIONS, DBS LEADS|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2013|12/11/2013|||APPR|APPROVAL FOR CHANGE TO AN AUTOMATED DESTRUCTIVE TEST ANALYSIS PROCESS.
P110028|S008|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice||N|05/31/2013|06/26/2013|||OK30|ADDITION OF A VENDOR OF THE STENT MARKER TABS.
P100047|S023|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2013|08/30/2013|||APPR|APPROVAL FOR THE HEARTWARE® WAIST PACK AND THE HEARTWARE® SHOULDER PACK.
P970004|S156|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY EXTENSIONS, SNS URINARY LEADS|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2013|12/11/2013|||APPR|APPROVAL FOR CHANGE TO AN AUTOMATED DESTRUCTIVE TEST ANALYSIS PROCESS.
P080025|S052|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL EXTENSIONS, SNS BOWEL LEADS|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2013|12/11/2013|||APPR|APPROVAL FOR CHANGE TO AN AUTOMATED DESTRUCTIVE TEST ANALYSIS PROCESS.
P010031|S382|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D/ XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|06/24/2013|||OK30|UPDATES TO THE BATTERY LASER MARKING EQUIPMENT AND PROCESS.
P980016|S421|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD , D VR ICD, ST DR ICD, XT VR ICD; MAXIMO II ICD, PROTECTA ICD/ XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|06/24/2013|||OK30|UPDATES TO THE BATTERY LASER MARKING EQUIPMENT AND PROCESS.
P050023|S066|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LUMAX|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2013|07/30/2013|||APPR|APPROVAL FOR AN ALTERNATE SEPARATOR MATERIAL USED IN THE LITRONIK BATTERIES FOR THE DEVICES.
P950037|S125|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|ECURO, EFFECTA, ESTELLA, EVIA ENTOVIS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2013|07/30/2013|||APPR|APPROVAL FOR AN ALTERNATE SEPARATOR MATERIAL USED IN THE LITRONIK BATTERIES FOR THE DEVICES.
P070008|S044|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ENTOVIS HF(-T), EVIA HF (-T)|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2013|07/30/2013|||APPR|APPROVAL FOR AN ALTERNATE SEPARATOR MATERIAL USED IN THE LITRONIK BATTERIES FOR THE DEVICES.
P100041|S031|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|07/03/2013|||OK30|THREE NEW FIXTURES USED IN THE MANUFACTURING PROCESS, REMOVAL OF A DEBURR MANDREL TOOL, AND ADDITIONAL INSPECTIONS ASSOCIATED WITH THESE CHANGES.
P110021|S017|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|07/03/2013|||OK30|THREE NEW FIXTURES USED IN THE MANUFACTURING PROCESS, REMOVAL OF A DEBURR MANDREL TOOL, AND ADDITIONAL INSPECTIONS ASSOCIATED WITH THESE CHANGES.
P860003|S074|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2013|08/28/2013|||APPR|APPROVAL FOR A CHANGE IN THE ADHESIVE USED FOR THE LIDSTOCK OF THE CELLEXS PROCEDURAL KIT PACKAGING.
P930038|S071|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|07/01/2013|||OK30|ELIMINATION OF THE SOFTWALL CONTROLLED ENVIRONMENT FOR THE MANUFACTURING OF TWO DEVICE COMPONENTS.
P080007|S017|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BRAD E-LUMINEXX VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2013|07/02/2013|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE CATHETER SHAFT IN YOUR DELIVERY SYSTEM.
P010012|S331|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN, PUNCTUA|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|07/03/2013|||OK30|AUTOMATION OF A MANUAL SIEVE PROCESS AT A SUPPLIER AND ADDITION OF A NEW REQUIREMENT TO SOURCE DOCUMENTATION FOR INCOMING ACCEPTANCE.
P960040|S296|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA, ENERGEN, PUNCTUA|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|07/03/2013|||OK30|AUTOMATION OF A MANUAL SIEVE PROCESS AT A SUPPLIER AND ADDITION OF A NEW REQUIREMENT TO SOURCE DOCUMENTATION FOR INCOMING ACCEPTANCE.
P030005|S100|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE, INTUA|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|07/03/2013|||OK30|AUTOMATION OF A MANUAL SIEVE PROCESS AT A SUPPLIER AND ADDITION OF A NEW REQUIREMENT TO SOURCE DOCUMENTATION FOR INCOMING ACCEPTANCE.
P020045|S049|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/04/2013|08/07/2013|||APPR|APPROVAL TO REPLACE THE OBSOLETE CENTRAL PROCESSING UNIT (CPU) OF THE CRYOCONSOLE WITH AN EQUIVALENT BOARD AND A FERRITE ADDITION TO THE FOOT PEDAL CONNECTOR.
P040034|S021|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2013|11/15/2013|||APPR|APPROVAL FOR A CHANGE TO THE LAYERING OF KITS IN THE CASE BOX USED FOR STERILIZATION.
P100010|S029|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC MODEL FRONT CARDIAC CRYOABLATION SYSTEM|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/04/2013|08/07/2013|||APPR|APPROVAL TO REPLACE THE OBSOLETE CENTRAL PROCESSING UNIT (CPU) OF THE CRYOCONSOLE WITH AN EQUIVALENT BOARD AND A FERRITE ADDITION TO THE FOOT PEDAL CONNECTOR.
P120005|S006|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2013|06/28/2013|||OK30|CHANGE TO THE SEMI-AUTOMATED ASSEMBLY EQUIPMENT FOR THREE SUB-ASSEMBLIES (CANNULA, PUSHROD CARRIER, AND NEEDLE CARRIER).
P080013|S009|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2013|11/15/2013|||APPR|APPROVAL FOR A CHANGE TO THE LAYERING OF KITS IN THE CASE BOX USED FOR STERILIZATION.
P080012|S018|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2013|06/24/2013|||OK30|ALTERNATE SUPPLIER FOR THE PROMETRA PROGRAMMABLE INFUSTINO PUMP.
P990038|S018|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2013|06/25/2013|||OK30|CHANGE TO THE QUALITY CONTROL TEST METHOD FOR A COMPONENT COMMON TO ALL DEVICES LISTED.
P990041|S017|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2013|06/25/2013|||OK30|CHANGE TO THE QUALITY CONTROL TEST METHOD FOR A COMPONENT COMMON TO ALL DEVICES LISTED.
P990042|S014|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2013|06/25/2013|||OK30|CHANGE TO THE QUALITY CONTROL TEST METHOD FOR A COMPONENT COMMON TO ALL DEVICES LISTED.
P990043|S018|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2013|06/25/2013|||OK30|CHANGE TO THE QUALITY CONTROL TEST METHOD FOR A COMPONENT COMMON TO ALL DEVICES LISTED.
P990044|S015|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2013|06/25/2013|||OK30|CHANGE TO THE QUALITY CONTROL TEST METHOD FOR A COMPONENT COMMON TO ALL DEVICES LISTED.
P990045|S015|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2013|06/25/2013|||OK30|CHANGE TO THE QUALITY CONTROL TEST METHOD FOR A COMPONENT COMMON TO ALL DEVICES LISTED.
P990009|S037|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/06/2013|05/27/2014|||APPR|APPROVAL FOR REVISED LABELING TO INCLUDE A SUMMARY OF THE NASSO ET AL. CLINICAL TRIAL, UPDATE THE DEVICE DESCRIPTION, AND EXTEND THE THROMBIN RECONSTITUTION PERIOD.
P100041|S032|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice||N|06/06/2013|07/03/2013|||OK30|IMPLEMENTATION OF A POSITIONING FIXTURE AS AN ALTERNATIVE MANUFACTURING AID USED WHILE PLACING TEMPORARY STITCHES ON TISSUE LEAFLETS.
P110021|S018|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice||N|06/06/2013|07/03/2013|||OK30|IMPLEMENTATION OF A POSITIONING FIXTURE AS AN ALTERNATIVE MANUFACTURING AID USED WHILE PLACING TEMPORARY STITCHES ON TISSUE LEAFLETS.
P050011|S004|BAXTER HEALTHCARE CORP.|1620 WAUKEGAN ROAD||MCGAW PARK|IL|60085||BARRIER, ABSORABLE, ADHESION|ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2013|07/02/2013|||OK30|REPLACE THE CURRENT PEPTIDOGLYCAN (PG) TEST METHOD WITH A HIGH SENSITIVITY PG (HS-PG) TEST METHOD.
P970020|S077|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ULTRA RX AND OTW CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2013|11/26/2013|||APPR|APPROVAL FOR A CHANGE TO YOUR IN-PROCESS STENT SUB-ASSEMBLY INSPECTION PROCESS.
P050006|S034|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2013|07/05/2013|||OK30|UPGRADE TO THE COATING STATION TIMER AND REMOVAL OF A REDUNDANT QUALITY CONTROL TEST.
P030022|S025|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM|MRA|OR|Real-Time Process||N|06/06/2013|08/30/2013|||APPR|APPROVAL FOR 1) ADDITIONAL SIZES OF R3 CERAMIC LINERS; AND 2) REVISION OF THE REFLECTION CERAMIC HIP SYSTEM LABELING (SURGICAL TECHNIQUE MANUAL AND SURGEON LABELING) TO REFLECT THE ADDITIONAL COMPONENTS.
P960009|S173|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACCESS THERAPY PATIENT CONTROLLER,ACCESS REVIEW THERAPY CONTROLLER|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2013|04/29/2016|||APPR|Approval for the replacement of the battery compartment labels of the hand-held patient programmers with labels whole pressure sensitive is resistant to the effects of high humidity.
P840001|S242|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL EZ PATIENT PROGRAMMER,SYNERGY EZ PATIENT PROGRAMMER,ACCESS THERAPY PATIENT CONTROLLER|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2013|04/29/2016|||APPR|Approval for the replacement of the battery compartment labels of the hand-held patient programmers with labels whole pressure sensitive is resistant to the effects of high humidity.
P090022|S018|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|INCLUSION OF THREE ADDITIONAL STEAM STERILIZER UNITS.
P110035|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/02/2013|||OK30|UPGRADED EQUIPMENT FOR ONE CHAMBER OF THE STERILIZATION FACILITY.
P980035|S332|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|ADDITIONAL STERILIZER SYSTEM AT MEDTRONICS SINGAPORE OPERATIONS.
P980035|S333|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|AUTOMATION OF THE FINAL PACKAGING LINES AT THE FINAL DEVICE MANUFACTURING FACILITY AT  MEDTRONIC IN PUERTO RICO.
P830061|S096|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE BIPOLAR LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|ADDITIONAL STERILIZER SYSTEM AT MEDTRONICS SINGAPORE OPERATIONS.
P010031|S383|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|AUTOMATION OF THE FINAL PACKAGING LINES AT THE FINAL DEVICE MANUFACTURING FACILITY AT  MEDTRONIC IN PUERTO RICO.
P930039|S092|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|ADDITIONAL STERILIZER SYSTEM AT MEDTRONICS SINGAPORE OPERATIONS.
P090013|S103|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|ADDITIONAL STERILIZER SYSTEM AT MEDTRONICS SINGAPORE OPERATIONS.
P090013|S104|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|AUTOMATION OF THE FINAL PACKAGING LINES AT THE FINAL DEVICE MANUFACTURING FACILITY AT  MEDTRONIC IN PUERTO RICO.
P980016|S422|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVER S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA IC|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|07/03/2013|||OK30|AUTOMATION OF THE FINAL PACKAGING LINES AT THE FINAL DEVICE MANUFACTURING FACILITY AT  MEDTRONIC IN PUERTO RICO.
P000037|S033|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETICHEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2013|11/14/2013|||APPR|APPROVAL FOR SEVERAL CHANGES TO YOUR ROUTINE STERILIZATION PROCESS.
P110038|S002|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/10/2013|||OK30|ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE COBAS AMPLIPREP INSTRUMENT.
P110013|S015|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM,RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice||N|06/10/2013|11/07/2013|||APPR|APPROVAL FOR CHANGES TO THE COMPONENTS AND THE SOFTWARE OF THE DRUG SPRAY MACHINE.
P900056|S123|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHRECTOMY SYSTEM|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|09/24/2013|||APPR|VENDOR CHANGE FOR THE ROTAGLIDE LUBRICANT.
P060022|S017|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/10/2013|||OK30|ADD AN ADDITIONAL MONOMER SUPPLIER.
P900056|S124|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM.|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/10/2013|||OK30|CHANGE TO THE IN-PROCESS STRAIGHTNESS INSPECTION CRITERIA FOR THE ROTAWIREWHICH IS PART OF THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM.
P930031|S045|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT RP ENDOPROSTHESIS TIPS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P980033|S034|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT RP ENDOPROSTHESIS VENOUS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P940019|S039|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT RP ENDOPROSTHESIS LLIAC|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P110042|S009|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2013|08/28/2013|||APPR|APPROVAL FOR MODEL 3200 Q-TECH PROGRAMMER TO BE USED WITH SQ-RX® PULSE GENERATOR (MODEL 1010) OF THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD®) SYSTEM ONLY.
P050019|S015|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P110035|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P090003|S024|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P020009|S108|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P040016|S114|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P850064|S023|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2013|05/15/2015|||APPR|APPROVAL FOR THE CHANGE THE THERMISTOR IN THE PATIENT CIRCUIT USED WITH THE LIFE PULSE HIGH FREQUENCY VENTILATOR.
P100029|S016|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|11/07/2013|||APPR|APPROVAL FOR AN ALTERNATE VENDOR FOR THE JAR AND LID COMPONENTS AS WELL AS A CHANGE TO THE JAR TOOLING.
P060006|S047|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P060008|S104|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P100023|S074|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P040021|S024|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR/EPIC VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|11/07/2013|||APPR|APPROVAL FOR AN ALTERNATE VENDOR FOR THE JAR AND LID COMPONENTS AS WELL AS A CHANGE TO THE JAR TOOLING.
P110010|S055|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P950020|S063|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|CORONARY FLEXTOME CUTTING BALLON|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2013|07/09/2013|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P090013|S105|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO DR MRI RVDR01|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2013|12/06/2013|||APPR|APPROVAL OF LABELING CHANGES TO REMOVE THE RESTRICTION STATING THAT THE PATIENT MUST BE POSITIONED WITHIN THE BORE SUCH THAT THE ISOCENTER (CENTER OF THE MRI BORE) IS SUPERIOR TO THE C1 VERTEBRA OR INFERIOR TO THE T12 VERTEBRA AS WELL AS TO REMOVE THE REQUIREMENT THAT MRI SCANS NOT BE PERFORMED ON PATIENTS WITH OTHER PREVIOUSLY IMPLANTED MEDICAL DEVICES.
P980035|S334|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR MRI A2DR01|NVZ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2013|12/06/2013|||APPR|APPROVAL OF LABELING CHANGES TO REMOVE THE RESTRICTION STATING THAT THE PATIENT MUST BE POSITIONED WITHIN THE BORE SUCH THAT THE ISOCENTER (CENTER OF THE MRI BORE) IS SUPERIOR TO THE C1 VERTEBRA OR INFERIOR TO THE T12 VERTEBRA AS WELL AS TO REMOVE THE REQUIREMENT THAT MRI SCANS NOT BE PERFORMED ON PATIENTS WITH OTHER PREVIOUSLY IMPLANTED MEDICAL DEVICES.
P030017|S169|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2013|07/11/2013|||OK30|UPDATE THE TEST SOFTWARE FOR THE APPLICATION SPECIFIC INTEGRATED CIRCUIT.
P950008|S010|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2013|07/15/2013|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO THE SILIKON 1000 OIL DIRECTIONS FOR USE.
P980044|S015|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2013|07/12/2013|||OK30|SHARING OF MANUFACTURING EQUIPMENT FOR USE WITH AN INVESTIGATIONAL PRODUCT.
P100041|S033|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|TRANSCATHER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2013|07/11/2013|||OK30|MODIFICATIONS TO THE MOLDS OF SOME OF THE CRIMPER COMPONENTS.
P110021|S019|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|TRANSCATHER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2013|07/11/2013|||OK30|MODIFICATIONS TO THE MOLDS OF SOME OF THE CRIMPER COMPONENTS.
P030017|S170|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2013|07/12/2013|||OK30|UPDATE THE TEST SOFTWARE FOR THE ELECTRONIC ASSEMBLY OF THE IMPLANTABLE PULSE GENERATOR.
P020004|S083|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCUDER AAA EDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2013|07/11/2013|||OK30|IMPLEMENTATION OF A NEW SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) TAPE USINGAN ALTERNATE PTFE RESIN RAW MATERIAL.
P020056|S022|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice||N|06/12/2013|07/10/2013|||OK30|ELECTRONIC DATA ACQUISITION SYSTEM (EDA) INSTEAD OF VIA A CHART RECORDER.
P040046|S004|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice||N|06/12/2013|07/10/2013|||OK30|ELECTRONIC DATA ACQUISITION SYSTEM (EDA) INSTEAD OF VIA A CHART RECORDER.
P040043|S054|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2013|07/11/2013|||OK30|IMPLEMENTATION OF A NEW SUPPLIER OF POLYTETRAFLUOROETHYLENE (PTFE) TAPE USINGAN ALTERNATE PTFE RESIN RAW MATERIAL.
P040033|S023|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2013|03/06/2014|||APPR|APPROVAL FOR A PACKAGING CHANGE FOR THE BHR FEMORAL HEADS ANDACETABULAR CUPS.
P990074|S027|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE FILLED BREAST IMPLANT|FWM|SU|30-Day Notice||N|06/12/2013|07/10/2013|||OK30|ELECTRONIC DATA ACQUISITION SYSTEM (EDA) INSTEAD OF VIA A CHART RECORDER.
P010013|S046|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM,  & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2013|07/10/2013|||OK30|MANUFACTURING PROCESS CHANGE FOR ONE OF THE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM COMPONENTS.
P830055|S135|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2013|07/17/2013|||OK30|CHANGES TO THE INSPECTION PROCESSES AND INSPECTION FREQUENCIES FOR THE LCS COMPLETE POLY PATELLA AND LCS COMPLETE MOBILE BEARING PATELLA.
P010023|S010|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM|MPV|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/2013|09/13/2013|||APPR|APPROVAL FOR USER INTERFACE SOFTWARE CHANGES AND PATIENT FITTING CHANGES TO THE OPTIMAX PROGRAMMER SOFTWARE.
P980041|S025|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/13/2013|10/17/2013|||APPR|APPROVAL FOR THE ADDITION OF NEW WARNINGS TO THE ACCESS 2 INSTRUMENT MANUALS.
P850048|S035|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/13/2013|10/17/2013|||APPR|APPROVAL FOR THE ADDITION OF NEW WARNINGS TO THE ACCESS 2 INSTRUMENT MANUALS.
P970038|S024|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/13/2013|10/17/2013|||APPR|APPROVAL FOR THE ADDITION OF NEW WARNINGS TO THE ACCESS 2 INSTRUMENT MANUALS.
P090026|S008|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/13/2013|10/17/2013|||APPR|APPROVAL FOR THE ADDITION OF NEW WARNINGS TO THE ACCESS 2 INSTRUMENT MANUALS.
P070014|S039|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2013|07/12/2013|||OK30|ACCEPTANCE FOR AN ALTERNATE SUB-SUPPLIER OF TACKIFIER RESIN TO THE APPROVED SUPPLIER OF STERILE BARRIER POUCHES FOR THE BARD® LIFESTENT® VASCULAR STENT SYSTEMS.
P060018|S003|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE CERVICAL DISC|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2013|07/12/2013|||OK30|CHANGE THE STERILIZATION TESTING PROCEDURE.
P020004|S084|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2013|07/10/2013|||OK30|IMPLEMENT THE USE OF ALTERNATE GLYTETRAFLUOROETHYLENE (PTFE) RESIN RAW MATERIAL.
P040043|S055|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2013|07/10/2013|||OK30|IMPLEMENT THE USE OF ALTERNATE GLYTETRAFLUOROETHYLENE (PTFE) RESIN RAW MATERIAL.
P050023|S067|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LLESTO, IFORIA, LUMAX,|MRM|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/14/2013|07/30/2013|||APPR|APPROVAL FOR THE MINOR LABELING MODIFICATIONS/CORRECTIONS, WHICH INCLUDES AN UPDATE OF THE INDICATION FOR USE STATEMENTS (IFU) TO INCLUDE THE MARKET APPROVED DEVICES WITH THE SAME IFU, AND OTHER MINOR CORRECTIONS TO THE LABELING.
P980023|S056|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX S DX|NVY|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/14/2013|07/30/2013|||APPR|APPROVAL FOR THE MINOR LABELING MODIFICATIONS/CORRECTIONS, WHICH INCLUDES AN UPDATE OF THE INDICATION FOR USE STATEMENTS (IFU) TO INCLUDE THE MARKET APPROVED DEVICES WITH THE SAME IFU, AND OTHER MINOR CORRECTIONS TO THE LABELING.
P010032|S072|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EONC 16-CHANNEL IPG NEUROSTIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2013|07/12/2013|||OK30|APPROVAL FOR A MANUFACTURING SITE LOCATED IN  MINNEAPOLIS, MINNESOTA.
P110042|S010|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICDO) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2013|07/12/2013|||OK30|USE OF MANUFACTURING TRACEABILITY AND TRACKING SYSTEM SOFTWARE.
N970003|S151|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSIGNIA, ALTRUA, INGENIO, ADVANTIO FAMILIES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2013|06/06/2013|||OK30|ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE EO REMOVAL PHASE.
N970012|S078|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2010|08/26/2010|||OK30|UPGRADE CERTAIN COMPONENTS USED IN THE JINHIBIZONE (IZ) TREATMENT.
N980003|S007|DJO SURGICAL|9800 METRIC BOULEVARD||AUSTIN|TX|78758||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/06/2008|02/13/2009|||APPR|APPROVAL FOR THE USE OF POLYETHYLENE REPLACEMENT ACETABULAR LINERS.
N970003|S152|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO, AND FORMIO|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2013|07/25/2013|||APPR|APPROVAL FOR MODEL 2869 ZOOMVIEW PROGRAMMER SOFTWARE APPLICATION V1.09 AND INGENIO FIRMWARE VERSION D_V1.02 WITH PATCH V1.01 FOR THE DEVICES.
N970003|S153|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO, AND FORMIO|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2013|07/03/2013|||OK30|AUTOMATION OF A MANUAL SIEVE PROCESS AT A SUPPLIER AND ADDITION OF A NEW REQUIREMENT TO SOURCE DOCUMENTATION FOR INCOMING ACCEPTANCE.
P000032|S041|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2013|07/15/2013|||OK30|ADDITION OF A NEW MOLDING VENDOR FOR THE FRONT HANDLE.
P100047|S024|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/17/2013|11/15/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY
P100047|S025|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/17/2013|11/15/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY
P100047|S026|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/17/2013|02/14/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010012|S332|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, ENERGEN INCEPTA COGNIS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2013|12/23/2013|||APPR|APPROVAL FOR THE BATTERY FEEDTHRU (FT) MATERIALS OF THE DEVICE.
P960040|S297|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, ENERGEN, INCEPTA, AND TELIGEN ICD|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2013|12/23/2013|||APPR|APPROVAL FOR THE BATTERY FEEDTHRU (FT) MATERIALS OF THE DEVICE.
P870056|S060|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS BIOSPROSTHETIC PULMONIC VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2013|07/16/2013|||OK30|REMOVAL OF A BIOLOGICAL INDICATOR REQUIREMENT FROM THE STERILIZATION CONVENTIONAL RELEASE PROGRAM TO ALIGN WITH THE LATEST VERSION OF THE ISO 14160 (2011) FOR LIQUID CHEMICAL STERILIZATION.
P110013|S016|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Normal 180 Day Track No User Fee|Other Report|N|06/17/2013|09/12/2013|||APPR|APPROVAL FOR A REVISED ELUTION SPECIFICATION.
P050006|S035|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/17/2013|07/17/2013|||APPR|APPROVAL TO UPDATE THE EXISTING GORE HELEX SEPTAL OCCLUDER INSTRUCTIONS FORUSE.
P100010|S030|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT AND ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHERTERS|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2013|07/26/2013|||APPR|APPROVAL FOR THE REMOVAL OF THE OUTER LEAK DETECTION WIRE AND ASSOCIATED INDUCTOR.
P030004|S007|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM (LES)|MFE|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2013|07/19/2013|||OK30|MODIFICATIONS TO THE ROUTER SOFTWARE.
P030031|S053|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM|LPB|CV|Normal 180 Day Track||N|06/17/2013|02/11/2014|||APPR|APPROVAL FOR THE ADDITION OF FORCE SENSING TECHNOLOGY TO THE CATHETER TIP.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERMOCOOL SMARTTOUCH CATHETER AND IS INDICATED FOR:THE BIOSENSE WEBSTER THERMOCOOL SMARTTOUCH NAVIGATION CATHETER AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF:1) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER;2) RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA(VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS; AND3) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.THE THERMOCOOL SMARTTOUCH NAVIGATION CATHETER PROVIDES A REAL-TIME MEASUREMENT OF CONTACT FORCE BETWEEN THE CATHETER TIP AND HEART WALL, AS WELL AS LOCATION INFORMATION WHEN USED WITH CARTO 3 NAVIGATION SYSTEM.
P040036|S037|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM|LPB|CV|Normal 180 Day Track||N|06/17/2013|02/11/2014|||APPR|APPROVAL FOR THE ADDITION OF FORCE SENSING TECHNOLOGY TO THE CATHETER TIP.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERMOCOOL SMARTTOUCHCATHETER AND IS INDICATED FOR:THE BIOSENSE WEBSTER THERMOCOOL SMARTTOUCH NAVIGATION CATHETER AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF:1) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER;2) RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA(VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS; AND3) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.THE THERMOCOOL SMARTTOUCH NAVIGATION CATHETER PROVIDES A REAL-TIME MEASUREMENT OF CONTACT FORCE BETWEEN THE CATHETER TIP AND HEART WALL, AS WELL AS LOCATION INFORMATION WHEN USED WITH CARTO 3 NAVIGATION SYSTEM.
N970012|S081|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2010|12/10/2010|||OK30|IMPLEMENTATION OF TWO CHANGES TO THE PARYLENE COATING OPERATION.
N970012|S082|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2010|12/15/2010|||OK30|CHANGE TO THE CONTRACT MANUFACTURING SITE OF A COMPONENT.
N970012|S083|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/17/2010|05/07/2012|||APPR|APPROVAL FOR CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS.
N970012|S084|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS|JCW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/2010|12/16/2010|||APPR|APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESES.
N970012|S085|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2010|12/22/2010|||OK30|CHANGE TO REPLACE THE STERILIZATION MONITORING DEVICE.
N970012|S086|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2010|12/22/2010|||OK30|CONTRACT MANUFACTURING SITE CHANGE FOR THE AMS 700 PROXIMAL TOOL.
N970012|S087|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2011|08/25/2011|||OK30|REPLACEMENT MOLD INSERT.
N970012|S088|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2011|09/20/2011|||OK30|NEW SOFTWARE-BASED MONITORING SYSTEM FOR A MANUFACTURING PROCESS.
N970012|S089|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2011|10/26/2011|||OK30|CHANGE IN THE PACKAGING PROCESS FOR THE DEVICES.
N970012|S090|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2012|05/02/2012|||OK30|CHANGE IN A MEASUREMENT METHOD USED DURING POST STERILE PACKAGING OPERATION.
N970012|S092|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2012|08/02/2012|||OK30|CHANGE IN THE LABEL DATABASE SERVER AND A LABELING SOFTWARE REVISION TO THE NICELABEL SYSTEM.
N970012|S093|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2012|10/05/2012|||OK30|THE SILICON RECEIVING INSPECTION AND MILLING PROCESSES TO BE STREAMLINED AND TO REMOVE DUPLICATE TESTING TO PROVIDE CONSISTENCY FOR THE ENTIRE SILICONE PROCESSES.
N970012|S094|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/20/2012|02/06/2013|||APPR|APPROVAL FOR THE LABELING CHANGE FROM 1.5 TESLA (1.5T) MAGNETICRESONANCE IMAGING (MRI) STRENGTH LEVEL TO 3.0 TESLA (3.0T) FOR THE BUNDLED AMS PRODUCTS. THEDEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES:1) AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) ARE INTENDED FOR USE IN THETREATMENT OF CHRONIC, ORGANIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE);2) AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) TREATS URINARY INCONTINENCE DUE TOREDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY; AND 3) AMS ACTICON NEOSPHINCTER, ARTIFICIAL BOWEL SPHINCTER (ABS) IS TO TREAT SEVERE FECALINCONTINENCE IN MALES AND FEMALES EIGHTEEN YEARS AND OLDER WHO HAVE FAILED, OR ARE NOTCANDIDATES FOR, LESS INVASIVE FORMS OF RESTORATIVE THERAPY.
N970012|S095|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/06/2012|01/03/2013|||OK30|IMPLEMENTATION OF A NITROGEN TEST AND NITROGEN FLOW TESTER FOR IN PROCESS INSPECTION OF FLOW RESISTORS USED IN THE PENILE PROTHESIS PRODUCT LINE.
P030002|S028|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|TRULIGN TORIC POSTER CHAMBER INTRAOCULAR LENS|MJP|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/18/2013|06/27/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100022|S006|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG ELUTING PERIPHERAL STENT|NIU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/19/2013|07/19/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) TO IMPROVE CLARITY BY PROVIDING RECOMMENDATIONS FOR APPROPRIATE GUIDEWIRE SELECTION AND ADDITIONAL INSTRUCTIONS FOR WHEN RESISTANCE IS ENCOUNTERED DURING CATHETER USE.
P090003|S025|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice||N|06/19/2013|07/18/2013|||OK30|ADDITIONAL VENDOR LOCATION TO SUPPLY MANUFACTURING AIDS AND COMPONENTS USED IN THE MANUFACTURING PROCESS OF THE DEVICES.
P930031|S046|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice||N|06/19/2013|07/18/2013|||OK30|ADDITIONAL VENDOR LOCATION TO SUPPLY MANUFACTURING AIDS AND COMPONENTS USED IN THE MANUFACTURING PROCESS OF THE DEVICES.
P980033|S035|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice||N|06/19/2013|07/18/2013|||OK30|ADDITIONAL VENDOR LOCATION TO SUPPLY MANUFACTURING AIDS AND COMPONENTS USED IN THE MANUFACTURING PROCESS OF THE DEVICES.
P050019|S016|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL|NIM|CV|30-Day Notice||N|06/19/2013|07/18/2013|||OK30|ADDITIONAL VENDOR LOCATION TO SUPPLY MANUFACTURING AIDS AND COMPONENTS USED IN THE MANUFACTURING PROCESS OF THE DEVICES.
P090016|S007|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2013|07/16/2013|||OK30|CHANGE TO THE PROTEIN CONTENT TEST METHOD.
P050037|S038|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2013|07/16/2013|||OK30|INCREASED MANUFACTURING HOLD TIME FOR THE GEL COMPONENT OF RADIESSE.
P050052|S041|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2013|07/16/2013|||OK30|INCREASED MANUFACTURING HOLD TIME FOR THE GEL COMPONENT OF RADIESSE.
P030017|S171|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2013|07/19/2013|||OK30|EXPAND THE DURATION OF THE LEAD REFLOW MANUFACTURING STEP.
P040047|S027|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2013|07/23/2013|||OK30|INCREASE THE MANUFACTURING HOLD TIME FOR THE GEL.
P110032|S005|LOMBARD MEDICAL TECHNOLOGIES INC|15420 LAGUNA CANYON ROAD|SUITE 260|IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2013|07/18/2013|||OK30|MODIFIED STERILIZATION CYCLE.
P100003|S003|GLOBUS MEDICAL INC.|2560 GENERAL ARMISTEAD AVE.||AUDUBON|PA|19403||PROSTHESIS, INTERVERTEBRAL DISC|SECURE -C CERVICAL ARTIFICIAL DISC|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/21/2013|05/08/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110042|S011|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIB RILLATOR (S-ICD) SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/21/2013|08/12/2013|||APPR|APPROVAL FOR SOFTWARE MAINTENANCE RELEASE SMR7.
P060007|S027|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG/HBSAG CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2013|07/18/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P050051|S021|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2013|07/18/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P960040|S298|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN,INCEPTA,ENERGEN,PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/24/2013|||OK30|BSC TO MANUFACTURE THE BATTERY FEEDTHRU FOR THE DEVICES.
P010012|S333|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS,INCEPTA,ENERGEN,PUNCTUA CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/24/2013|||OK30|BSC TO MANUFACTURE THE BATTERY FEEDTHRU FOR THE DEVICES.
P980035|S336|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG,ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/16/2013|||OK30|UPDATE TO THE FINAL FUNCTIONAL TEST APPLICATION.
P010015|S206|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/16/2013|||OK30|UPDATE TO THE FINAL FUNCTIONAL TEST APPLICATION.
P100022|S007|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG ELUTING PERIPHERAL STENT|NIU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/23/2013|||OK30|CHANGE IN INCOMING ACCEPTANCE ACTIVITIES AND CHANGES TO THE MANUFACTURING PROCESS AND TEST METHOD FOR THE INNER CATHETER.
P110035|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/24/2013|||OK30|ALTERNATE ETHYLENE OXIDE (EO) STERILIZATION CYCLE FOR THE EPIC VASCULAR SELF-EXPANDING STENT SYSTEM.
P980006|S021|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION (BALAFILCON A) VISIBILLITY TINTED CONTACT LENS,PUREVISION TORIC (BALAFILCON A)  VISIBILITY TINTED CONTACT LEN|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/17/2013|||OK30|MODIFICATION OF THE DISTILLATION PROCESS.
P100041|S034|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/22/2013|||OK30|REPLACING THE MOLD USED TO FORM THE SOFT TIP COMPONENT OF THE RETROFLEX 3 DELIVERY SYSTEM.
N17600|S028|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/24/2013|||OK30|APPROVAL FOR A PROPOSED RELOCATION OF RAW MATERIAL PROCESSING EQUIPMENT TO A NEW BUILDING WITHIN THE SAME RAW MATERIAL SUPPLIER ADDRESS.
P800002|S019|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/24/2013|||OK30|APPROVAL FOR A PROPOSED RELOCATION OF RAW MATERIAL PROCESSING EQUIPMENT TO A NEW BUILDING WITHIN THE SAME RAW MATERIAL SUPPLIER ADDRESS.
P110021|S020|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATETER HEART VALVE AN TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/22/2013|||OK30|REPLACING THE MOLD USED TO FORM THE SOFT TIP COMPONENT OF THE RETROFLEX 3 DELIVERY SYSTEM.
P960040|S299|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/24/2013|||OK30|BOSTON SCIENTIFIC CORPORATION TO MANUFACTURE THE BATTERY HALVES CASE FOR THE DEVICES.
P010012|S334|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA CRT-D , ENERGEN CRT-D PUNCTUA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2013|07/24/2013|||OK30|BOSTON SCIENTIFIC CORPORATION TO MANUFACTURE THE BATTERY HALVES CASE FOR THE DEVICES.
P900060|S052|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2013|07/25/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE QUALITY CONTROL INSPECTION OF SILICON CONTENT ON THE CPHV PYC COMPONENTS.
P100044|S010|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT|OWO|EN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/25/2013|08/13/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) AND LABELS THAT ENHANCE THE SAFETY IN THE USE OF THE PROPEL AND PROPEL MINI SINUS IMPLANTS.
P100047|S027|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2013|07/25/2013|||OK30|CHANGE IN THE SUPPLIER OF THE PATCH USED TO COVER THE SPEAKER ON THE DEVICE CONTROLLER.
P970003|S164|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY ACCESSORY PACK|MUZ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2013|09/23/2013|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE IN-LINE TEST RESISTOR THAT IS USED INCONJUNCTION WITH SINGLE PIN PULSE GENERATORS DURING PERIOPERATIVE TROUBLESHOOTING.
P980016|S423|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice||N|06/26/2013|07/26/2013|||OK30|UPDATE TO THE NEXT GENERATION HYBRID TESTER TO RELEASE 35.0.
P010031|S384|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA ICD, MAXIMO CRT-D||CV|30-Day Notice||N|06/26/2013|07/26/2013|||OK30|UPDATE TO THE NEXT GENERATION HYBRID TESTER TO RELEASE 35.0.
P040025|S014|Natus Medical Incorporated|5900 First Avenue South||Seattle|WA|98108||Cap,cooling (infants)|OLYMPIC COOL-CAP SYSTEM|MXM|NE|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/26/2013|12/23/2013|||APPR|APPROVAL FOR A POST-APPROVAL STUDY (REGISTRY) LABELING UPDATE FOR THE OLYMPIC COOL-CAP SYSTEM.
P020004|S085|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSATHESIS WITH C3 DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/2013|08/26/2013|||APPR|APPROVAL FOR REDUCING THE SIZE OF THE SECOND DEPLOYMENT LINE SLIP KNOT LOOP AND A NEW DEPLOYMENT TEST FIXTURE INSERT.
P990046|S033|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|MEDTRONIC OPEN PIVOT HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2013|07/26/2013|||OK30|NEW PIECE OF EQUIPMENT INTENDED TO MACHINE CARBON ORIFICE COMPONENTS.
P070026|S016|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/27/2013|11/21/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950039|S026|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP-5000|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/2013|03/02/2015|||APPR|APPROVAL FOR THINPREP 5000 PROCESSOR.
P000025|S070|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2013|09/25/2013|||APPR|APPROVAL FOR UPDATING THE REPROCESSING INSTRUCTIONS FOR ALL CURRENTLYAPPROVED MED-EL REUSABLE SURGICAL TOOLS.
P070026|S017|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/27/2013|08/27/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P080009|S001|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/27/2013|06/16/2014|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE HARDWARE, FIRMWARE, AND SOFTWARE AND A NEW MANUFACTURING FACILITY AT FLEX MEDICAL IN TIJUANA, MEXICO.
P840064|S054|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT OPTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2013|07/24/2013|||OK30|REDUCTION OF THE MINIMUM AERATION TIME FOR THE BLISTER PACKS.
P110013|S017|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/05/2013|07/02/2013|||APPR|APPROVAL FOR AN UPDATED ANNUAL STABILITY PROTOCOL TO BRACKET THE ADDITIONAL 34 MM AND 38 MM LENGTH STENT SIZES.
P120006|S004|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRIVASCULAR, INC. OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/27/2013|08/27/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980044|S016|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2013|07/25/2013|||OK30|USE OF NEWLY CONSTRUCTED CLEANROOM DOORS AND ASSOCIATED AIRLOCKS.
P890055|S048|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2013|07/15/2014|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING PROCESS OF THE MEDSTREAM DEVICE TO REQUIRE A POST-STERILIZATION FILL LEVEL SENSOR (FLS) FUNCTIONAL INSPECTION.
P110019|S050|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVERLIMUS CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/28/2013|12/19/2013|||APPR|APPROVAL FOR A LABELING CHANGE TO EXTEND THE SHELF LIFE TO 36 MONTHS FOR THE RX PLATFORMS OF THE DEVICES.
P110039|S003|InSightec|5 NAHUM HETH STREET||TIRAT-CARMEL||39120||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE|NRZ|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/28/2013|08/06/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010047|S030|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/28/2013|09/25/2013|||APPR|APPROVAL FOR REMOVAL OF THE UPPER LIMIT SEAL STRENGTH SPECIFICATION FOR THE STERILE BARRIER POUCH PACKAGING AND REPLACING IT WITH THE PEEL-OPEN VERIFICATION TEST.
P970051|S110|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/28/2013|05/08/2014|||APPR|APPROVAL FOR A CHANGE TO THE ASSEMBLY CONSTRUCTION OF EXTERNAL SWITCHES ON THE CP810 SOUND PROCESSOR WITH THE INTENTION OF IMPROVING INGRESS PROTECTION AND THEREFORE CORROSION RESISTANCE.
P100025|S005|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)|OZA|MI|Normal 180 Day Track||N|06/28/2013|04/18/2014|||APPR|APPROVAL FOR THE ADDITION OF THE POCONE INFRARED SPECTROPHOTOMETER FOR PEDIATRIC USE.
P060040|S028|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2013|09/25/2013|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE UNIVERSAL BATTERY CHARGER.
P100020|S008|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2013|04/24/2014|14M-0552|04/24/2014|APPR|APPROVAL FOR THE COBAS® HPV TEST. THE COBAS® HPV TEST INDICATIONS FOR USE:  THE COBAS® HPV TEST IS A QUALITATIVE IN VITRO TEST FOR THE DETECTION OF HUMAN PAPILLOMAVIRUS IN CERVICAL SPECIMENS COLLECTED BY A CLINICIAN USING AN ENDOCERVICAL BRUSH/SPATULA AND PLACED IN THE THINPREP® PAP TESTTM PRESERVCYT® SOLUTION. THE TEST UTILIZES AMPLIFICATION OF TARGET DNA BY THE POLYMERASE CHAIN REACTION (PCR) AND NUCLEIC ACID HYBRIDIZATION FOR THE DETECTION OF 14 HIGH-RISK (HR) HPV TYPES IN A SINGLE ANALYSIS. THE TEST SPECIFICALLY IDENTIFIES TYPES HPV16 AND HPV18 WHILE CONCURRENTLY DETECTING THE REST OF THE HIGH RISK TYPES (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 AND 68).THE COBAS® HHPV TEST IS INDICATED:1) TO SCREEN PATIENTS 21 YEARS AND OLDER WITH ASC-US (ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE) CERVICAL CYTOLOGY TEST RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY; 2) TO BE USED IN PATIENTS  PLEASE SEE APPROVAL ORDER FOR FURTHER INFORMATION.
P990046|S034|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2013|07/30/2013|||APPR|APPROVAL FOR REVISING THE LIST OF POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE.
P810031|S049|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES(OVD), HEALON, HEALON GV AND HEALON5 PRODUCTS|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|ALTERNATE BULK PACKAGE SHIPPING CONFIGURATION.
P060038|S017|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2013|04/18/2014|||APPR|APPROVAL FOR MANUFACTURING PROCESS CHANGES TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE, MODEL LX, CONSISTING OF IMPLEMENTATION OF THE PHOSPHOLIPID REDUCTION TREATMENT MANUFACTURING PROCESS (AN ANTICALCIFICATION TREATMENT PROCESS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P060033|S078|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|SOFTWARE ENHANCEMENTS AND UPDATES TO THE FOURIER TRANSFORM NEAR INFRARED (FT-NIR) SYSTEM USED FOR THE INCOMING ACTIVE PHARMACEUTICAL INGREDIENT (API) IDENTIFICATION TESTING.
P110013|S018|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|SOFTWARE ENHANCEMENTS AND UPDATES TO THE FOURIER TRANSFORM NEAR INFRARED (FT-NIR) SYSTEM USED FOR THE INCOMING ACTIVE PHARMACEUTICAL INGREDIENT (API) IDENTIFICATION TESTING.
P080011|S025|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|RELOCATION OF BIOFINITY LINE #4 IN THE SAME PRODUCTION AREA AND ALSO A CHANGE IN THE MOLDING MACHINE PLATFORM.
P010012|S335|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA,ENERGEN,PUNCTUA CRTS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|CHANGE TO THE VACUUM BAKE DURATION AND NUMBER OF OPTIONAL RE-BAKES FOR AN ELECTRICAL COMPONENT IN THE PULSE GENERATORS FOR THE DEVICES.
P960040|S300|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA,ENERGEN,PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|CHANGE TO THE VACUUM BAKE DURATION AND NUMBER OF OPTIONAL RE-BAKES FOR AN ELECTRICAL COMPONENT IN THE PULSE GENERATORS FOR THE DEVICES.
P870072|S055|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD)|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2013|12/10/2013|||APPR|APPROVAL OF THE ADDITION OF A PVAD ISOLATION MODULE (PIM) FOR USE WITH THE PVAD AND THE DUAL DRIVE CONSOLE (DDC).
P960043|S082|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2013|08/29/2013|||APPR|APPROVAL FOR A CHANGE TO THE BACKDOWN DETENT (BDD) FORCESPECIFICATION FOR THE PROSTAR XL® PVS SYSTEM.
P100023|S075|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/28/2013|||OK30|MODIFICATIONS TO REDUCE THE INSPECTION WAIT TIME FOR A MOLDED MANIFOLD COMPONENT.
P110010|S056|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/28/2013|||OK30|MODIFICATIONS TO REDUCE THE INSPECTION WAIT TIME FOR A MOLDED MANIFOLD COMPONENT.
P010031|S385|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/26/2013|||OK30|CHANGE IN THE PLATING PROCESS MANUFACTURING STEPS FOR THE PATIENT ALERT FLEX CIRCUIT ASSEMBLY FOR THE DEVICES.
P060037|S023|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/31/2013|||OK30|CHANGE TO A CLEAN ROOM ENVIRONMENT USED IN PRODUCTION OF THE DEVICE.
P030009|S065|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/26/2013|||OK30|MODIFICATIONS TO THE STENT SUBASSEMBLY ANNEALING PROCESS AND UPGRADES TO AN ANNEALING OVEN.
P980016|S424|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/26/2013|||OK30|CHANGE IN THE PLATING PROCESS MANUFACTURING STEPS FOR THE PATIENT ALERT FLEX CIRCUIT ASSEMBLY FOR THE DEVICES.
P930014|S069|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/2013|04/28/2014|||APPR|APPROVAL FOR THREE ALTERNATE POLYPROPYLENE MATERIALS, BASELL PD702, EXXON ACHIEVE 1605, AND EXXON PP1105E1, FOR INTRAOCULAR LENS (IOL) DEVICE PRIMARY PACKAGING.
P040020|S048|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENS|MFK|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/2013|04/28/2014|||APPR|APPROVAL FOR THREE ALTERNATE POLYPROPYLENE MATERIALS, BASELL PD702, EXXON ACHIEVE 1605, AND EXXON PP1105E1, FOR INTRAOCULAR LENS (IOL) DEVICE PRIMARY PACKAGING.
P110042|S012|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR SYSTEM (S-ICD)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2013|08/20/2013|||APPR|APPROVAL FOR TWO ALTERNATE COMPONENTS USED ON THE LOW POWER HYBRID ASSEMBLY FOR THE S-ICD SYSTEM.
P980035|S337|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2013|07/30/2013|||OK30|ADDITION OF AN AUTOMATED WET SAW CUTTING PROCESS.
P030017|S172|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2013|07/30/2013|||OK30|UPDATE THE TEST EQUIPMENT SYSTEM FOR THE CHARGER.
P010015|S207|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2013|07/30/2013|||OK30|ADDITION OF AN AUTOMATED WET SAW CUTTING PROCESS.
P060033|S079|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/26/2013|||OK30|MODIFICATIONS TO THE STENT SUBASSEMBLY ANNEALING PROCESS AND UPGRADES TO AN ANNEALING OVEN.
P110013|S019|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/26/2013|||OK30|MODIFICATIONS TO THE STENT SUBASSEMBLY ANNEALING PROCESS AND UPGRADES TO AN ANNEALING OVEN.
P110011|S003|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/26/2013|||OK30|MODIFICATIONS TO THE STENT SUBASSEMBLY ANNEALING PROCESS AND UPGRADES TO AN ANNEALING OVEN.
P990064|S051|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|NEWLY CONSTRUCTED CONTROLLED ENVIRONMENT AREA (CEA) AT THE MANUFACTURING FACILITY IN SANTA ANA, CA.
P980043|S043|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II BIOPROSTHETIC HEART VALVE|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|NEWLY CONSTRUCTED CONTROLLED ENVIRONMENT AREA (CEA) AT THE MANUFACTURING FACILITY IN SANTA ANA, CA.
P790007|S039|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|NEWLY CONSTRUCTED CONTROLLED ENVIRONMENT AREA (CEA) AT THE MANUFACTURING FACILITY IN SANTA ANA, CA.
P870078|S022|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|NEWLY CONSTRUCTED CONTROLLED ENVIRONMENT AREA (CEA) AT THE MANUFACTURING FACILITY IN SANTA ANA, CA.
P970031|S043|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2013|07/30/2013|||OK30|NEWLY CONSTRUCTED CONTROLLED ENVIRONMENT AREA (CEA) AT THE MANUFACTURING FACILITY IN SANTA ANA, CA.
P010012|S337|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA,ENERGEN,PUNCTUA CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2013|07/30/2013|||OK30|CHANGE IN THE SUPPLIERS MANUFACTURING PROCESS FOR THE PRINTED CIRCUIT BOARDS (PCBS) OF THE DEVICES.
P030017|S173|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2013|08/01/2013|||OK30|UPDATE THE TEST EQUIPMENT SYSTEM FOR THE PRINTED CIRCUIT BOARD ASSEMBLY FOR THE IMPLANTABLE PULSE GENERATOR.
P960040|S302|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA,ENERGEN,PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2013|07/30/2013|||OK30|CHANGE IN THE SUPPLIERS MANUFACTURING PROCESS FOR THE PRINTED CIRCUIT BOARDS (PCBS) OF THE DEVICES.
P030017|S174|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2013|07/31/2013|||OK30|UPDATE THE TEST SOFTWARE FOR THE IMPLANTABLE PULSE GENERATOR.
P090013|S106|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG.|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2013|07/30/2013|||OK30|ADDITION OF AN AUTOMATED WET SAW CUTTING PROCESS.
P840001|S243|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION (SCS) NEUROSTIMULATORS IMPLANTABLE (INS) RESTORE FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2013|08/02/2013|||OK30|CHANGES WITHIN THE RESTORESMALL BATTERY BURN-IN AND INSPECTION PROCESS.
P960009|S174|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION (DBS) INS ACTIVA FAMILY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2013|08/02/2013|||OK30|CHANGES WITHIN THE RESTORESMALL BATTERY BURN-IN AND INSPECTION PROCESS.
P010047|S031|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2013|08/01/2013|||OK30|CHANGES IN THE UV BONDING PROCESS FOR THE PROGEL® EXTENDED TIPS PROVIDED WITH THE PROGEL PLEURAL AIR LEAK SEALANT KIT.
P080011|S026|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2013|08/06/2013|||OK30|INTRODUCTION OF AUTOMATED MANUFACTURING EQUIPMENT.
P100041|S035|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART, MODEL 9000TFX|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2013|08/02/2013|||OK30|REPLACEMENT OF A DISINFECTANT FOR NON-PRODUCT CONTACT SURFACES.
P110021|S021|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHER HEART VALVE, MODEL 9000TFX|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2013|08/02/2013|||OK30|REPLACEMENT OF A DISINFECTANT FOR NON-PRODUCT CONTACT SURFACES.
P980003|S038|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOL ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2013|08/28/2013|||APPR|APPROVAL FOR A MATERIAL CHANGE TO AN ALREADY KNOWN MATERIAL FOR YOUR SOLDER AND FLUX.
P100003|S005|GLOBUS MEDICAL INC.|2560 GENERAL ARMISTEAD AVE.||AUDUBON|PA|19403||PROSTHESIS, INTERVERTEBRAL DISC|SECURE -C CERVICAL ARTIFICIAL DISC|MJO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2013|12/18/2014|||APPR|APPROVAL FOR ADDITIONAL DEVICE SIZES.
P810002|S087|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT, STANDARD, AND MASTERS MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2013|08/08/2013|||OK30|CHANGE TO THE FABRIC SUPPLIER LOCATION.
P870072|S056|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2013|07/16/2013|||OK30|ADDITION OF A NEW DIRECTIONAL FLOW VALVE (DFV) LEAK TESTER.
P060040|S029|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2013|08/05/2013|||OK30|ADDITION OF THORATEC CORPORATION AS A SECONDARY SOURCE FOR THE ASSEMBLY OF THE 14V BATTERY CLIPS FOR THE THORATEC® HEARTMATE® II VENTRICULAR ASSIST SYSTEM (LVAS).
P050047|S031|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/03/2013|11/26/2013|||APPR|APPROVAL FOR CHANGE TO THE CONCENTRATION OF THE LIDOCAINE SOLUTION INTRODUCED TO THE GEL DURING THE HOMOGENIZATION STEP FROM 50% W/W TO 30% W/V LIDOCAINE HYDROCHLORIDE AND A REVALIDATION, BY WEIGHT, THE AMOUNT OF GEL THAT CAN BE MIXED DURING THE HOMOGENIZATION STEP OF THE MANUFACTURING PROCESS.
P100047|S028|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2013|08/02/2013|||OK30|USE OF AN ADDITIONAL LASER WORKSTATION FOR IMPLEMENTATION OF WELD TAPERING ANDLASER SMOOTHING PROCESSES FOR THE DEVICE IMPELLER.
P990046|S035|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT|LWQ|CV|30-Day Notice||N|07/08/2013|08/07/2013|||OK30|REVIEW OF: 1) INSTALLATION QUALIFICATION (IQ) REPORTS FOR 4 PIECES OF EQUIPMENTRELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT; AND 2) ONE PROCESS QUALIFICATION (PQ) REPORT FOR ONE PIECE OF EQUIPMENT RELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT. THESE CHANGES APPLY TO THE OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT.
P890003|S280|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2013|09/27/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
P980016|S425|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST,INTRINSIC 30,INTRINSIC,MARQUIS DR,MARQUIS VR,MAXIMO DR,MAXIMO VR ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2013|09/27/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
P890040|S007|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOF-FORM 55 EW, LL-55, SOFTCON EW 2|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2013|08/06/2013|||OK30|DIRECT HYDRATION OF LENSES.
P090015|S001|Leica Biosystems|36 Cherry Hill Drive||Danvers|MA|01923||SYSTEM, TEST, HER-2/NEU, IHC|BOND ORACLE HER2 IHC SYSTEM|MVC|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/2013|02/11/2014|||APPR|APPROVAL FOR THE MANUFACTURING CHANGES TO THE BOND-MAX SOFTWARE, INSTRUMENT STYLING AND USABILITY, THE REAGENT AND BOND-MAX INSTRUMENT MANUFACTURING PROCESSES, AND ASSOCIATED LABELING CHANGES.
P980035|S338|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA,ADVISA DR,ADVISA DR MRI,ENPULSE E1,ENPULSE E2,ENRHYTHM,KAPPA D(KAPPA 700),KAPPA D (KAPPA 900) IPG, K|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2013|09/27/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
P010015|S208|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2013|09/27/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
P010031|S386|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INSYNC II PROTECT, INSYNC III MARQUIS,INSYNC MARQUIS, INSYNC MAXIMO ICDS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2013|09/27/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
P090013|S107|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/08/2013|09/27/2013|||APPR|APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
P060025|S012|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|3F AORTIC BIOPROSTHESIS, MODEL 1000|LWR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/09/2013|10/02/2013|||APPR|APPROVAL FOR A CHANGE TO THE PACKAGING SYSTEM FOR THE 3F AORTICBIOPROSTHESIS, MODEL 1000.
P820003|S122|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER (AAI/VVI) AND MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2013|08/09/2013|||OK30|PACKAGING SITE AND PRODUCT RELEASE CHANGES FOR THE MODEL 5846 DISPOSABLE PATIENT CABLES.
P010031|S387|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D|NIK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2013|10/04/2013|||APPR|APPROVAL FOR ADDING NON-MEDTRONIC DEFIBRILLATION LEADS TO RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) LABELING.
P980016|S426|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2013|10/04/2013|||APPR|APPROVAL FOR ADDING NON-MEDTRONIC DEFIBRILLATION LEADS TO RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) LABELING.
P890003|S281|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SYNERGYST II PACING SYSTEM|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2013|12/11/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TECHNICAL SERVICES FOR ELECTRONICS, INC., IN  JACKSON, MINNESOTA.
P820003|S123|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX PACING SYSTEM|LWP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2013|12/11/2013|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT TECHNICAL SERVICES FOR ELECTRONICS, INC., IN  JACKSON, MINNESOTA.
P000025|S071|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MAESTRO COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2013|08/07/2013|||OK30|STANDARDIZATION OF ELECTRODE REINFORCEMENT SPRINGS.
P000025|S072|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2013|01/10/2014|||APPR|APPROVAL FOR AN ALTERNATE WELDING PROCESS.
P120005|S007|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2013|08/09/2013|||OK30|ADD AN ALTERNATE DEXCOM SUPPLIER OF A COMPONENT USED IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
P100041|S036|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2013|08/09/2013|||OK30|CHANGE TO THE QUALITY INSPECTION SAMPLING PLAN FOR THE RETROFLEX BALLOON CATHETER GUIDEWIRE SHAFT.
P940035|S010|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|ALERE NMP22 TEST|NAH|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2013|07/16/2013|||APPR|APPROVAL FOR ADDITIONS TO THE LIMITATIONS AND PRECAUTIONS SECTIONS OF THE PACKAGE INSERT.
P110021|S022|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2013|08/09/2013|||OK30|CHANGE TO THE QUALITY INSPECTION SAMPLING PLAN FOR THE RETROFLEX BALLOON CATHETER GUIDEWIRE SHAFT.
P080026|S008|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REAL TIME HBV|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2013|09/10/2013|||APPR|APPROVAL FOR A CHANGE TO A DATA REDUCTION PARAMETER IN THE APPLICATION SPECIFICATION FILES.
P010015|S209|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2013|09/16/2013|||APPR|APPROVAL FOR A MINOR MODIFICATION TO THE ANCHORING SLEEVE INSTALLEDON THE ATTAIN BIPOLAR OTW LEAD MODEL 4194.
P100046|S003|ATRICURE INC.|386 WEST MAIN STREET, SUITE 7||NORTHBOROUGH|MA|01532||Surgical cardiac ablation device, for treatment of atrial fibrillation|ATRICURE SYNERGY ABLATION SYSTEM|OCM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/12/2013|08/26/2015|||APPR|APPROVAL FOR A DESIGN CHANGE THAT INCLUDES REPLACEMENT OF THE CURRENT ISOLATOR AND ELECTRODE SUB-ASSEMBLIES WITH AN OVER MOLDED CONFIGURATION.
P040002|S043|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2013|08/12/2013|||APPR|APPROVAL OF NEW PLATINUM/TUNGSTEN RADIOPAQUE COIL MARKERS TO BE ADDED CIRCUMFERENTIALLY IN THE PROXIMAL HEM OF THE SUPRARENAL AND INFRARENAL PROXIMAL EXTENSION ACCESSORY STENT GRAFTS.
P860057|S110|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/16/2013|||OK30|CHANGE TO THE RESIN USED IN A COMPONENT MATERIAL IN THE TRICENTRIX HOLDER SYSTEM AND JAR ASSEMBLY.
P080027|S012|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2013|08/01/2013|||APPR|APPROVAL FOR ADDING MORE REPLICATES IN QC TESTING PROCEDURES.
P890047|S041|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/07/2013|||OK30|USE OF A COMPOUNDING ISOLATOR FOR STERILE INCORPORATION.
P840064|S055|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DUOVISC & DISCOVISC OPTHALMIC VISCOSURGICAL DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/07/2013|||OK30|USE OF A COMPOUNDING ISOLATOR FOR STERILE INCORPORATION.
P010014|S044|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE|NRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/12/2013|07/30/2013|||APPR|APPROVAL FOR CHANGES TO THE SURGICAL TECHNIQUE MANUAL.
P020004|S086|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/05/2013|||OK30|ADDITION OF A NEW WRAPPER MACHINE.
P040027|S031|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/05/2013|||OK30|ADDITION OF A NEW WRAPPER MACHINE.
P040037|S054|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIBAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/05/2013|||OK30|NEW WRAPPER MACHINE.
P040043|S056|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/05/2013|||OK30|ADDITION OF A NEW WRAPPER MACHINE.
P120012|S001|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REAL TIME HCV GENOTYPE 11|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/01/2013|||OK30|CHANGE TO THE SAMPLING PLAN FOR THE REAGENT VIAL FILLING PROCEDURE.
P050006|S036|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/05/2013|||OK30|ADDITION OF A NEW WRAPPER MACHINE.
P840001|S244|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|VARIOUS MODELS OF THE ITREL 4, RESTORE, & SURE SCAN MRI FAMILIES OF IMPLANTABLE SPINAL CORD STIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/01/2013|||OK30|CHANGE TO REDUCE THE HYBRIDPRODUCTION BURN-IN TIME FOR THE  IMPACTED PRODUCTS.
P860004|S192|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II DRUG PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/01/2013|||OK30|CHANGE TO REDUCE THE HYBRIDPRODUCTION BURN-IN TIME FOR THE  IMPACTED PRODUCTS.
P960009|S175|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC,SC,AND RC IMPLANTABLE DEEP BRAIN STIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/01/2013|||OK30|CHANGE TO REDUCE THE HYBRIDPRODUCTION BURN-IN TIME FOR THE  IMPACTED PRODUCTS.
P970004|S157|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II IMPLANTABLE SACRAL NERVE STIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/01/2013|||OK30|CHANGE TO REDUCE THE HYBRIDPRODUCTION BURN-IN TIME FOR THE  IMPACTED PRODUCTS.
P080025|S053|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM  II IMPLANTABLE SACRAL NERVE STIMULATORS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/12/2013|08/01/2013|||OK30|CHANGE TO REDUCE THE HYBRIDPRODUCTION BURN-IN TIME FOR THE  IMPACTED PRODUCTS.
P120012|S002|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/13/2013|||OK30|CHANGE TO AN IN-PROCESS TEST METHOD FOR A COMPONENT OF THE ABBOTT REALTIME HCV GENOTYPE II.
P810025|S034|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/13/2013|||OK30|CHANGE IN THE EXISTING CLEAN ROOM INTO A FORMULATION ROOM.
P900009|S035|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN ULTRASOUND BONE HEALING SYSTEM|LPQ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/15/2013|05/29/2014|||APPR|APPROVAL FOR A NEW BIOVENTUS MANUFACTURING FACILITY IN CORDOVA, TENNESSEE, MANUFACTURING PROCESS CHANGES, A RECHARGEABLE BATTERY AND CHARGER, REDESIGN OF THE MAIN OPERATING UNIT, CHANGES TO THE INSTRUCTIONS FOR USE, AND MODIFIED PACKAGING.
P060037|S024|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|02/18/2014|||APPR|APPROVAL FOR REPLACING THE MANUAL LABELING VERIFICATION PROCESS WITH AN AUTOMATED SYSTEM.
P860004|S193|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II AND SYNCHROMED EL DRUG PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/05/2013|||OK30|SUPPLIER BE CLEARED TO MANUFACTURE A PRINTED CIRCUIT BOARD ASSEMBLY AT AN ALTERNATE FACILITY.
P950029|S080|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/13/2013|||OK30|ADDITION OF NON-FUNCTIONAL STRUCTURES WITHIN THE METAL LAYERS AND THEMODIFICATION OF THE VISUAL INSPECTION PROCESS FOR INTEGRATED CIRCUITS IN THE IMPLANTABLE PULSE GENERATORS.
P980049|S083|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750, PARADYM DR8750|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/13/2013|||OK30|ADDITION OF NON-FUNCTIONAL STRUCTURES WITHIN THE METAL LAYERS AND THEMODIFICATION OF THE VISUAL INSPECTION PROCESS FOR INTEGRATED CIRCUITS IN THE IMPLANTABLE PULSE GENERATORS.
P020025|S042|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|MAESTRO 3000 CARDIAC ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/14/2013|||OK30|ACCEPTANCE OF THE VALIDATION OF THE HI-POT TEST EQUIPMENT USED IN THE IN-PROCESS RF BOARD TESTING.
P060027|S051|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARASYM CRT-D 8750|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/13/2013|||OK30|ADDITION OF NON-FUNCTIONAL STRUCTURES WITHIN THE METAL LAYERS AND THEMODIFICATION OF THE VISUAL INSPECTION PROCESS FOR INTEGRATED CIRCUITS IN THE IMPLANTABLE PULSE GENERATORS.
P030031|S054|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/22/2013|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER FOR THE MANUFACTURING OF TIP ELECTRODES FOR THE FAMILY OF PRODUCTS.
P040036|S038|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL NAV|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2013|08/22/2013|||OK30|ADDITION OF A SECOND SOURCE SUPPLIER FOR THE MANUFACTURING OF TIP ELECTRODES FOR THE FAMILY OF PRODUCTS.
P010031|S388|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2013|08/14/2013|||OK30|IMPLEMENTATION OF AN UPDATED BATTERY DIMENSIONAL INSPECTION ROUTINE.
P980016|S427|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2013|08/14/2013|||OK30|IMPLEMENTATION OF AN UPDATED BATTERY DIMENSIONAL INSPECTION ROUTINE.
P050023|S068|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IFORIA VR-T ICD, LLESTO VR-T ICD, LUMAX VR-T ICD,IFORIA VR-T DX ICD, LLESTO VR-T DX ICD, LUMAX VR-T DX ICD,|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2013|08/14/2013|||OK30|IMPLEMENT A NEW ETHYLENE OXIDE STERILIZATION CYCLE AT A CONTRACT STERILIZATION SITE.
P070008|S045|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ENTOVIS HF(-T) CRT-P, EVIA HF(-T) CRT-P, STRATOS CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2013|08/14/2013|||OK30|IMPLEMENT A NEW ETHYLENE OXIDE STERILIZATION CYCLE AT A CONTRACT STERILIZATION SITE.
P950037|S126|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ECURO, EFFECTA, ESTELLA,EVIA, ENTOVIS IMPLANTABLE PACEMAKER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2013|08/14/2013|||OK30|IMPLEMENT A NEW ETHYLENE OXIDE STERILIZATION CYCLE AT A CONTRACT STERILIZATION SITE.
N970012|S096|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)|JCW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/16/2013|08/14/2013|||APPR|APPROVAL FOR MODIFICATIONS OF THE OPERATING ROOM MANUAL BY ADDITIONAL EMPHASIS, INSTRUCTIONS, AND INFORMATION FOR TUBE INFLATION/DEFLATION ISSUES IN THE TROUBLESHOOTING, SURGICAL, AND POST-OPERATIVE PROCEDURE SUB-SECTIONS.
P050034|S010|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X & WIDE ANGLE2.7X|NCJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2013|08/09/2013|||OK30|ADD AN ASSEMBLY JIG INTO THE MANUFACTURING PROCESS.
P120005|S008|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2013|08/21/2013|||OK30|ADDITION OF NEW GOWNING ROOMS.
P110021|S023|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/17/2013|09/13/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110035|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/15/2013|||OK30|UPDATE THE CURRENT SOFTWARE ON THE EPIC WETLINE ELECTROPOLISHING SYSTEM.
P960058|S103|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|12/24/2013|||APPR|APPROVAL FOR AN ALTERNATE RESIN MATERIAL FOR THE ELECTRODE WIRES.
P010015|S210|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA  AND SYNCRA CRT-P'S|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/12/2013|||OK30|CHANGE FOR AN INCOMING MATERIAL ACCEPTANCE PROCEDURE FOR UNDERFILL CURE EPOXY.
P010031|S389|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONSULTA ICD & BRAVA, CONCERTO II, MAXIMO II,PROTECTA/PROTECTA XT, VIVA S/XT CRT- D'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/12/2013|||OK30|CHANGE FOR AN INCOMING MATERIAL ACCEPTANCE PROCEDURE FOR UNDERFILL CURE EPOXY.
P110029|S012|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT HBSAG QUALITATIVE CONFIRMATORY REAGENT|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/08/2013|||OK30|CHANGE TO THE TEST METHOD FOR THE HBSAG CONFIRMATORY STANDARDS.
P090013|S108|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/12/2013|||OK30|CHANGE FOR AN INCOMING MATERIAL ACCEPTANCE PROCEDURE FOR UNDERFILL CURE EPOXY.
P980016|S428|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA  S DR/VR & XT DR/ VR, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO II DR/ VR ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/12/2013|||OK30|CHANGE FOR AN INCOMING MATERIAL ACCEPTANCE PROCEDURE FOR UNDERFILL CURE EPOXY.
P980035|S339|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA, ADVISA DR/DR MRI, RELIA IPG'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/12/2013|||OK30|CHANGE FOR AN INCOMING MATERIAL ACCEPTANCE PROCEDURE FOR UNDERFILL CURE EPOXY.
P110013|S020|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY SYSTEM (RX AND OTW)|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2013|09/05/2013|||APPR|APPROVAL FOR CHANGING THE SAMPLING SCHEME USED FOR ANALYTICAL LOT RELEASE TESTING FOR THE DEVICES.
P960043|S083|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE/PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEMS AND SNARED KNOT PUSHER|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2013|01/16/2014|||APPR|APPROVAL FOR THE USE OF AN INTERNAL FACILITY AS AN ADDITIONAL SUPPLIER OF THREE EXTRUDED COMPONENTS.
P050007|S031|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2013|01/16/2014|||APPR|APPROVAL FOR THE USE OF AN INTERNAL FACILITY AS AN ADDITIONAL SUPPLIER OF THREE EXTRUDED COMPONENTS.
P100041|S037|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2013|01/31/2014|||APPR|APPROVAL FOR A CHANGE IN MATERIAL TO THE MANDRELS USED AS MANUFACTURING AIDS FOR THE DELIVERY SYSTEM.
P110021|S024|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2013|01/31/2014|||APPR|APPROVAL FOR A CHANGE IN MATERIAL TO THE MANDRELS USED AS MANUFACTURING AIDS FOR THE DELIVERY SYSTEM.
P000025|S073|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2013|08/15/2013|||OK30|QUALIFICATION OF AN ADDITIONAL WELDING PROCESS.
P030017|S175|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2013|08/16/2013|||OK30|MODIFICATION OF THE LEAK DETECTION TESTING.
P950032|S074|ORGANOGENESIS, INC.|150 DAN RD.||CANTON|MA|02021||Dressing, wound and burn, interactive|APLIGRAF|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2013|08/13/2013|||OK30|ALTERNATE VENDOR TO SUPPLY PROCESSING TRAYS FOR USE IN THE MANUFACTURING PROCESS OF APLIGRAF.
P000029|S075|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/2013|10/17/2013|||APPR|APPROVAL FOR LABELING CHANGES, WHICH ADD TWO ADDITIONAL TECHNIQUES FOR INJECTION, THE HIT AND DOUBLE-HIT.
P810031|S050|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV AND HEALON5|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2013|08/15/2013|||OK30|SODIUM HYALURONATE RAW MATERIAL QUALITY CONTROL TESTING.
P110022|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ASSAY (COBAS E 601 ANALYZER)|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/2013|08/06/2013|||APPR|APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR IN-PROCESS TESTING OF A BULK REAGENT.
P110025|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ASSAY (MODULAR ANALYTICS E170 ANALYZER)|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/2013|08/06/2013|||APPR|APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR IN-PROCESS TESTING OF A BULK REAGENT.
P110031|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER)|LOM|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/19/2013|08/06/2013|||APPR|APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR IN-PROCESS TESTING OF A BULK REAGENT.
P910001|S066|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2013|08/21/2013|||OK30|CHANGE IN THE PRIMARY VENDOR FOR THE ELECTRODE PLATING PROCESS.
P010014|S045|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2013|08/21/2013|||APPR|APPROVAL TO UPDATE THE INSPECTION CRITERIA USED FOR THE OXFORD® PARTIAL KNEE FEMORAL, TIBIAL, AND MOBILE BEARING COMPONENTS MANUFACTURED AT THE WARSAW, INDIANA SITE.
P980053|S015|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|30-Day Notice||N|07/22/2013|08/19/2013|||OK30|ADDITION OF A NEW TEXTURE ANALYZER SYSTEM.
P890023|S019|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|OCUFILCON D SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2013|08/21/2013|||OK30|ADDITION OF NEW EQUIPMENT TO MEASURE AIRBORNE PARTICLES IN THE JUANA DIAZ, PUERTO RICO FACILITY.
P910077|S136|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ZOOM LATITUDE PROGRAMMER|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2013|08/21/2013|||OK30|ALTERNATE SUPPLIER FOR THE OFF-THE-SHELF FLASH MEMORY CHIP TO BE USED ON THEINPUT/OUTPUT (I/O) PRINTED CIRCUIT ASSEMBLY (PCA) OF THE DEVICE.
P030017|S176|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2013|08/21/2013|||OK30|ADDITION OF NEW ACCEPTANCE CRITERIA TO THE CHARGING COIL.
P110010|S057|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2013|08/21/2013|||OK30|ADD CONTROLS AND EXTEND EXISTING FUNCTIONALITY TO THE CARTON LABELING AND CARTON COMPONENT VERIFICATION (CCV) WORKSTEP.
P030050|S018|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AND SCULPTRA AESTHETIC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2013|08/16/2013|||OK30|THE FOLLOWING CHANGES: 1) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION OF STERILIZATION AT THE DAGNEUX FRANCE FACILITY; 2) PACKAGING MODIFICATION FOR THE RAW MATERIAL, INCLUDING A NEW BAG SUPPLIER AND THE INTRODUCTION OF A NEW BAGGING CONFIGURATION; AND 3) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION AT THE SABLÉ FRANCE FACILITY.
P780007|S051|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|POLYMACON SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2013|08/20/2013|||OK30|ADDITION OF NEW EQUIPMENT TO MEASURE AIRBORNE PARTICLES AT THE JUANA DIAZ, PUERTO RICO FACILITY.
P120012|S003|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2013|08/20/2013|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR OLIGONUCLEOTIDES AND THE ADDITION OF TWO NEW SUPPLIERS FOR A RAW MATERIAL.
P100017|S007|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2013|08/20/2013|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR OLIGONUCLEOTIDES AND THE ADDITION OF TWO NEW SUPPLIERS FOR A RAW MATERIAL.
P080026|S009|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV|MKT|MI|30-Day Notice||N|07/23/2013|08/20/2013|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR OLIGONUCLEOTIDES AND THE ADDITION OF TWO NEW SUPPLIERS FOR A RAW MATERIAL.
P100018|S008|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE  EMBOLIZATION DEVICE|OUT|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2013|10/22/2013|||APPR|APPROVAL FOR A DESIGN CHANGE FOR THE SHORTER PIPELINE¿ EMBOLIZATIONDEVICES (PED), MODEL NUMBERS FA-77XXX-XX, WITH LENGTHS BETWEEN 10MM AND 20MM. THIS DESIGN CHANGE INVOLVES REPLACING THE DELIVERY CORE WIRE CURRENTLY AVAILABLE ON THESE SHORTER PED LENGTHS (RM-00013-XX) WITH THE DELIVERY CORE WIRE CURRENTLY AVAILABLE ON THE LONGER PEDLENGTHS (RM-00089-XX), MODEL NUMBERS FA-71XXX-XX, BETWEEN 25MM AND 35MM.
P100022|S008|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG ELUTING PERIPHERAL STENT|NIU|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/2013|10/22/2013|||APPR|APPROVAL FOR TIGHTENING THE DRUG POTENCY SPECIFICATION AND EXPANSION OF YOUR DEVICE SHELF-LIFE FROM 6 MONTHS TO 12 MONTHS.
P020050|S014|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2013|10/18/2013|||APPR|APPROVAL FOR THE WAVENET¿ PLANNING SOFTWARE (WPS), A STAND-ALONE USER INTERFACE SOFTWARE SYSTEM FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE WPS ENABLES THE PHYSICIAN TO PLAN SURGICAL CASES REMOTELY IN ADVANCE OF THE PLANNED SURGICAL DATE.
P030008|S012|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2013|10/18/2013|||APPR|APPROVAL FOR THE WAVENET¿ PLANNING SOFTWARE (WPS), A STAND-ALONE USER INTERFACE SOFTWARE SYSTEM FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE WPS ENABLES THE PHYSICIAN TO PLAN SURGICAL CASES REMOTELY IN ADVANCE OF THE PLANNED SURGICAL DATE.
P840001|S245|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|VARIOUS MODELS OF THE ITREL 4, RESTORE, AND SURE SCAN MRI FAMILES OF IMPLANTABLE SPINAL CORD STIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/12/2013|||OK30|ALTERNATE FIRST TIER SUPPLIER OFEXTENSION/CONNECTOR END ASSEMBLIES AND ELECTRODE END ASSEMBLIES.
P960009|S176|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC, SC, AND RC IMPLANTABLE DEEP BRAIN STIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2013|08/12/2013|||OK30|ALTERNATE FIRST TIER SUPPLIER OFEXTENSION/CONNECTOR END ASSEMBLIES AND ELECTRODE END ASSEMBLIES.
P050018|S019|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT PTCA SCORING BALLOON CATHETER|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2013|08/21/2013|||OK30|ADDITIONAL POUCH SEALERS.
P080014|S017|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR ASSAY|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2013|08/22/2013|||OK30|CHANGE TO INCREASE THE MANUFACTURING SCALE FOR OLIGONUCLEOTIDE PRODUCTION.
P120005|S009|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/2013|10/17/2014|||APPR|APPROVAL FOR THE DEXCOM SHARE SYSTEM AS AN OPTIONAL ACCESSORY OF THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEXCOM SHARE SYSTEM IS MANUFACTURED AT LEADTEK RESEARCH INC. IN TAIWAN, CHINA.
P090003|S026|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILLIAC PEMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2013|08/22/2013|||OK30|CHANGE TO THE PRE-ELECTROPOLISH LASER CUT DIMENSIONS FOR THE 57MM LONG SMALL VESSEL (SV) AND LARGE VESSEL (LV) STENTS.
P100021|S027|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Postapproval Study Protocol - OSB|N|07/25/2013|01/24/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P080006|S056|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEADS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2013|08/22/2013|||OK30|CHANGE IN THE CONDUCTOR COIL CLEANING PROCESS FOR ATTAIN ABILITY LEAD MODELS 4196, 4296, AND 4396.
P980022|S135|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGUM REAL TIME PUMP; PARADIGUM REAL TIME REVEL INSULIN PUMP|MDS|CH|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/24/2013|08/23/2013|||APPR|APPROVAL OF LABELING CHANGES TO THE USER GUIDE AND TO THE TWO PACKAGE INSERTS (ERRATA SHEETS) FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, AND MMT-722K), AND FOR THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEMS.
P950027|S014|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN|MOZ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/29/2013|09/26/2013|||APPR|APPROVAL FOR A NEW INJECTION SYRINGE (DENOTED AS ¿EZ-FILL SYRINGE¿) FOR HYALGAN® THAT INCORPORATES A TAMPER-EVIDENT CLOSURE SYSTEM CONSISTING OF A SEAL, A TIP CAP, AND A LUER LOCK.
P080020|S005|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2013|08/23/2013|||OK30|USE OF MANUFACTURING EQUIPMENT FOR DEVELOPMENT USE.
P050017|S008|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2013|08/22/2013|||OK30|CHANGE THE MANUFACTURING PROCESS OF FLARING THE POLYETHYLENE REINFORCED SLEEVES FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P090013|S109|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P010031|S390|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA,VIVA S,VIVA XT CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|IMPLEMENT THE USE OF A SEMI-AUTOMATED VISION SYSTEM TO VERIFY THE CRIMP HEIGHT OF THE CAPACITOR FEEDTHROUGH IN THE DEVICES.
P980016|S429|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|IMPLEMENT THE USE OF A SEMI-AUTOMATED VISION SYSTEM TO VERIFY THE CRIMP HEIGHT OF THE CAPACITOR FEEDTHROUGH IN THE DEVICES.
P120005|S010|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/19/2013|||OK30|ADDITION OF A -20°C UPRIGHT LABORATORY FREEZER TO THE SENSOR MANUFACTURING EQUIPMENT.
P050012|S051|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/19/2013|||OK30|ADDITION OF A -20°C UPRIGHT LABORATORY FREEZER TO THE SENSOR MANUFACTURING EQUIPMENT.
N18033|S073|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON(SENOFILCON A) BRAND CONTACT LENSES,VISTAKON(ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/16/2013|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE PRIMARY PACKAGING.
P040045|S040|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON(ETAFILCON A) BRAND CONTACT LENSES,VISTAKON(SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/16/2013|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE PRIMARY PACKAGING.
P110037|S007|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/CONAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/21/2013|||OK30|CHANGE TO ADD AN ALTERNATE SUPPLIER FOR A CRITICAL RAW MATERIAL.
P060030|S033|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST,V2.0,; HIGH PURE/COBAS TAQMAN HCV V20.3 TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/21/2013|||OK30|CHANGE TO ADD AN ALTERNATE SUPPLIER FOR A CRITICAL RAW MATERIAL.
P890003|S282|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P980035|S340|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG; ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P010031|S391|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTO II CRT-D, COSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P920015|S114|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT,  HV SPLITTER/ ADAPTOR KIT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P990001|S115|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG; C60 DR IPG; T20 SR IPG; T60 DR IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P980016|S430|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; INTRINSIC ICD; MARQUIS DR ICD, VR ICD; MAXIMO DR ICD, MAXIMO II ICD, MAX|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P010015|S211|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/22/2013|||OK30|ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.
P010013|S047|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/26/2013|04/25/2014|||APPR|APPROVAL FOR DECREASED OUTER SHEATH DIAMETER, MODIFICATION OF THE CERVICAL SEAL DESIGN, AND CHANGE IN THE FRONT HANDLE COLOR.
P100020|S009|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/21/2013|||OK30|CHANGE TO ADD AN ALTERNATE SUPPLIER FOR A CRITICAL RAW MATERIAL.
P110020|S007|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/21/2013|||OK30|CHANGE TO ADD AN ALTERNATE SUPPLIER FOR A CRITICAL RAW MATERIAL.
P120019|S001|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2013|08/21/2013|||OK30|CHANGE TO ADD AN ALTERNATE SUPPLIER FOR A CRITICAL RAW MATERIAL.
P960009|S177|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DBS LEAD, ACTIVA DBS LEAD REDUCED SPACING|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|08/27/2013|||OK30|ADDITION OF A NEW ANNEALING VACUUM OVEN.
P100040|S012|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM|MIH|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/29/2013|01/22/2014|14M-167|02/04/2014|APPR|APPROVAL FOR THE VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (VALIANT CAPTIVIA).  THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA (DTA) IN PATIENTS HAVING THE APPROPRIATE ANATOMY INCLUDING:  1) ILIAC OR FEMORAL ARTERY ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES OR ACCESSORIES; NONANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18 MM TO 42 MM (FUSIFORM AND SACCULAR ANEURYSMS/PENETRATING ULCERS), OR 18 MM TO 44 MM (BLUNT TRAUMATIC AORTIC INJURIES), OR 20 MM TO 44 MM (DISSECTIONS); AND NONANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS ¿ 20 (FUSIFORM AND SACCULAR ANEURYSMS/ PENETRATING ULCERS), LANDING ZONE ¿20 MM PROXIMAL TO THE PRIMARY ENTRY TEAR (BLUNT TRAUMATIC AORTIC INJURIES, DISSECTIONS).  THE PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED.
P110028|S009|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|08/27/2013|||OK30|CHANGE TO THE ELECTROPOLISH SOLUTION USED IN THE MANUFACTURE OF THE STENTS OF THE DEVICES.
P040012|S052|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|08/27/2013|||OK30|CHANGE TO THE ELECTROPOLISH SOLUTION USED IN THE MANUFACTURE OF THE STENTS OF THE DEVICES.
P970051|S111|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|08/26/2013|||OK30|ADDITION OF A SECOND IDENTICAL BRAZING OVEN.
P070015|S113|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|08/27/2013|||OK30|CHANGE IN THE TEST EQUIPMENT USED FOR THE IDENTIFICATION AND ASSAY OF BUTYLATED HYDROXYTOLUENE (BHT).
P110019|S051|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORNARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|07/29/2013|08/27/2013|||OK30|CHANGE IN THE TEST EQUIPMENT USED FOR THE IDENTIFICATION AND ASSAY OF BUTYLATED HYDROXYTOLUENE (BHT).
P840001|S246|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EXTERNAL NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEUROSTIMULATOR FOR SPINAL CORD STIMULATION,RESTOREPRIME NEUROSTIMULATOR,|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|08/27/2013|||OK30|CHANGE TO INCLUDE AN ADDITIONALINCOMING MATERIAL ACCEPTANCE TEST METHOD FOR UNDERFILL EPOXY.
P860004|S194|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|08/27/2013|||OK30|CHANGE TO INCLUDE AN ADDITIONALINCOMING MATERIAL ACCEPTANCE TEST METHOD FOR UNDERFILL EPOXY.
P010032|S073|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI IPG NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|04/25/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO LLC, IN ARECIBO, PUERTO RICO.
P960009|S178|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|EXTERNAL NEUROSTIMULATOR,ACTIVIA PC NEUROSTIMULATOR,ACTIVIA SC NEUROSTIMULATOR,ACTIVA RC NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2013|08/27/2013|||OK30|CHANGE TO INCLUDE AN ADDITIONALINCOMING MATERIAL ACCEPTANCE TEST METHOD FOR UNDERFILL EPOXY.
P020045|S050|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/29/2013|09/27/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950037|S127|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable pulse generator, pacemaker (non-CRT)|ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2013|09/26/2013|||APPR|APPROVAL FOR AN ALTERNATE SEPARATOR MATERIAL USED IN THE GREATBATCH BATTERIES FOR THE DEVICES.
P070008|S046|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ENTOVIS HF (-T),EVIA HF(-T)|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2013|09/26/2013|||APPR|APPROVAL FOR AN ALTERNATE SEPARATOR MATERIAL USED IN THE GREATBATCH BATTERIES FOR THE DEVICES.
P080030|S010|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2013|08/28/2013|||OK30|ELIMINATE COMPRESSED AIR CLEANING OF THE PACKAGE TRAYS AND ADDITION OF AN ALTERNATE TRAY VENDOR.
P030005|S101|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INTUA|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2013|08/22/2013|||OK30|ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE ETHYLENE OXIDE REMOVAL PHASE.
N970003|S154|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VITALIO, FORMIO|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2013|08/22/2013|||OK30|ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE ETHYLENE OXIDE REMOVAL PHASE.
P830055|S136|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)||N|07/29/2013|08/28/2013|||APPR|APPROVAL FOR THE ADDITION OF INSPECTIONS TO CHECK THE PROFILE OF THE DISTAL CONDYLES AS WELL AS THE MEDIAL-LATERAL (M/L) WIDTH AND TRUE POSITION OF THE SIGMA CR150 SIZE 5 & 6 FEMORAL COMPONENTS DURING THE MANUFACTURING PROCESS. THE SIGMA CR150 FEMORAL COMPONENTS WERE PREVIOUSLY APPROVED AS COMPATIBLE COMPONENTS TO THE PRIMARY CURVED RP BEARING INSERTS AND MBT TIBIAL TRAYS.
P990081|S021|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2013|08/22/2013|||OK30|ADD A SUPPLIER (FEF CHEMICALS) OF A RAW MATERIAL (RECOMBINANT HUMAN INSULIN) FOR THE BD CELL MAB MEDIA BASE AND TO BRING THE FORMULATION OF THIS MEDIA FROM BECTON DICKINSON INTO IN-HOUSE PRODUCTION AT VENTANA MEDICAL SYSTEMS, INC., IN  TUCSON, ARIZONA.
P080015|S009|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18|MAQ|MI|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|07/31/2013|04/29/2014|||APPR|APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE.
P910023|S320|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ICD DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2013|08/28/2013|||OK30|ALTERNATE LOCATION FOR THE PARYLENE COATING PROCESS.
P030054|S252|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT- D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2013|08/28/2013|||OK30|ALTERNATE LOCATION FOR THE PARYLENE COATING PROCESS.
P080014|S018|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR AND GENFIND KIT|MAQ|MI|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|07/31/2013|04/29/2014|||APPR|APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE.
P990075|S024|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SPECTRUM BREAST IMPLANTS|FWM|SU|30-Day Notice||N|07/31/2013|08/20/2013|||OK30|ADD AN ADDITIONAL SUB-SUPPLIER OF THE CONNECTOR SYSTEM THAT IS PROVIDED AS AN ACCESSORY WITH THE DEVICES.
P910061|S020|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2013|08/21/2013|||OK30|ADDITION OF AN ALTERNATE PACKAGING COMPONENT SUPPLIER.
P090018|S023|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/27/2013|||OK30|ADDITIONAL MANUFACTURING LOCATION FOR THE MEDCEM CEMENT.
P010013|S048|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETERIAL ABALTION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/20/2013|||OK30|CHANGE FROM A MANUAL INSPECTION PROCESS TO AN AUTOMATED INSPECTION PROCESS OF INCOMING DEVICE COMPONENTS.
P840062|S031|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2013|08/29/2013|||OK30|INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.
P810006|S044|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT, MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2013|08/29/2013|||OK30|INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.
P850010|S042|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2013|08/29/2013|||OK30|INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.
P900033|S031|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2013|08/29/2013|||OK30|INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.
P110013|S021|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTERGRITY RX ZOTAROLIMUS-ELUTING CORONARY SYSTEM, RESOLUTE INTEGRITY OTW ZOTAROLIMUS-ELUTING CORONARY SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|12/12/2013|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE C10 AND C19 POLYMERS.
P070026|S018|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/01/2013|10/23/2013|||APPR|APPROVAL FOR ADDITION OF PINNACLE 300 AND MULTI-HOLE II ACETABULAR CUP COMPONENTS AS COMPATIBLE COMPONENTS.
P840062|S032|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOLE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/23/2013|||OK30|CHANGE TO A COMPONENT SHIPPING CONTAINER.
P810006|S045|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/23/2013|||OK30|CHANGE TO A COMPONENT SHIPPING CONTAINER.
P850010|S043|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/23/2013|||OK30|CHANGE TO A COMPONENT SHIPPING CONTAINER.
P110042|S013|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/22/2013|||OK30|PERFORM RECEIVING AND INSPECTION ACTIVITIES FOR CERTAIN COMPONENTS AND ACCESSORIES USED IN THE CAMERON HEALTH, INC. S-ICD SYSTEM AT BOSTON SCIENTIFIC CORPORATIONS MANUFACTURING FACILITY LOCATED IN ST PAUL, MINNESOTA.
P110013|S022|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/28/2013|||OK30|MODIFY THE PROCESS CONTROLS RELATED TO THE PACKAGING SEALED SEAM.
P040005|S010|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 IQFISH PHARMDX|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/28/2013|||OK30|ADDITIONAL PROBE DNA LABELING OPTION FOR LABELING DNA POOLS.
P100024|S005|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2013|08/28/2013|||OK30|ADDITIONAL PROBE DNA LABELING OPTION FOR LABELING DNA POOLS.
P950029|S082|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2013|08/30/2013|||OK30|ALTERNATIVE LASER WELDING EQUIPMENT FOR THE CLOSING OF  THE DEVICES.
P110013|S023|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY OVER-THE-WIRE ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2013|08/29/2013|||OK30|INTRODUCE AN ALTERNATIVE BUILDING FOR THE MANUFACTURE OF THE MICROTRAC OTW DELIVERY SYSTEM WITHIN THE SAME APPROVED MANUFACTURING FACILITY.
P030009|S066|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY OVER-THE-WIRE CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2013|08/29/2013|||OK30|INTRODUCE AN ALTERNATIVE BUILDING FOR THE MANUFACTURE OF THE MICROTRAC OTW DELIVERY SYSTEM WITHIN THE SAME APPROVED MANUFACTURING FACILITY.
P050011|S005|BAXTER HEALTHCARE CORP.|1620 WAUKEGAN ROAD||MCGAW PARK|IL|60085||BARRIER, ABSORABLE, ADHESION|ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)|MCN|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|08/02/2013|10/29/2013|||APPR|APPROVAL FOR A NEW POLYVINYLCHLORIDE STORAGE BAG FOR THE ADEPT ADHESION REDUCTION SOLUTION.
P080014|S019|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR TEST|MAQ|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2013|03/04/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GEN-PROBE INCORPORATED, SAN DIEGO, CALIFORNIA FOR THE MANUFACTURING OF THE CERVISTA HPV HR AND THE CERVISTA HPV 16/18.
P080015|S010|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18 TEST|MAQ|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2013|03/04/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT GEN-PROBE INCORPORATED, SAN DIEGO, CALIFORNIA FOR THE MANUFACTURING OF THE CERVISTA HPV HR AND THE CERVISTA HPV 16/18.
P010019|S035|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|O2OPTIX, AIR OPTRIX AQUA, AIR OPTIX FOR ASTIGMATISM ; AIR OPTIX AQUA MULTIFOCAL|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2013|08/28/2013|||OK30|PACKAGING LINE UPGRADE.
P840062|S033|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2013|04/07/2014|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES:  1) A NEW ALKALINE DETERGENT FOR USE AS A CLEANING AGENT; 2) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES; 3) SWAB AND RINSE RECOVERY FACTORS AND A VISUAL LIMIT OF DETECTION FOR MEDICAL MANUFACTURING AREA SOIL ON STAINLESS STEEL AND ALUMINUM SURFACES; 4) PROPOSED CHANGE IN EQUIPMENT DIRTY HOLD TIMES (DHTS) FOR THE DOUBLE DENSITY HEMOSTATIC DISPERSION, CROSS-LINKING PROCESS EQUIPMENT AND THE MOLD FILLING EQUIPMENT; AND5) PROPOSED INSTALLATION AND OPERATIONAL QUALIFICATION OF A NEW ULTRASONICATOR.
P040001|S021|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP LTOS|NQO|OR|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/05/2013|12/12/2014|||APPR|APPROVAL FOR AN UPDATE TO THE X STOP® INTERSPINOUS SPACER SYSTEM LABELING TO REFLECT THE RESULTS FROM THE LONG TERM OUTCOMES STUDY (LTOS) THAT WAS CONDUCTED AS A POSTAPPROVAL STUDY REQUIREMENT.
P110042|S014|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANCEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2013|09/27/2013|||APPR|APPROVAL FOR TWO ALTERNATE SILICON CAPACITORS USED ON THE LOW POWER HYBRID ASSEMBLY FOR THE S-ICD SYSTEM.
P100023|S076|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/05/2013|08/28/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880086|S234|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT DR RF,ACCENT SR RF PACEMAKER DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2013|09/05/2013|||OK30|CHANGE IN THE ENCAPSULATION CURE PROCESS FOR THE LEFT VENTRICULAR RADIOFREQUENCY (LV RF) MODULES IN THE DEVICES.
P030035|S112|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM RF CRT-PS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2013|09/05/2013|||OK30|CHANGE IN THE ENCAPSULATION CURE PROCESS FOR THE LEFT VENTRICULAR RADIOFREQUENCY (LV RF) MODULES IN THE DEVICES.
P890003|S283|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/06/2013|10/07/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES.
P010031|S392|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S,BR|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/06/2013|10/07/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES.
P980016|S431|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO DR,VIRTUOSO VR,SECURA DR,MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR,PROTE|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/06/2013|10/07/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES.
P050042|S025|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV LN 1L79|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2013|08/30/2013|||OK30|ELIMINATION OF THE SPECIFICITY PANEL TESTING USED TO DETERMINE THE EFFECTIVENESS OF A PREVENTIVE ACTION.
P060008|S105|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/05/2013|09/29/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030011|S021|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/07/2013|12/24/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980003|S039|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2013|09/04/2013|||OK30|CHANGE TO AN IN-PROCESS INSPECTION FREQUENCY FOR THE ELECTRODE RING ADHESIVE COMPONENT OF THE CHILLI II COOLED ABLATION CATHETER.
P100047|S029|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2013|09/06/2013|||OK30|REPLACEMENT OF THE CURRENT STERILIZATION PROCESS CHALLENGE DEVICE WITH AN ALTERNATIVE PROCESS CHALLENGE DEVICE FOR MONITORING OF ETHYLENE OXIDE STERILIZED COMPONENTS OF THE DEVICE.
P090018|S024|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2013|11/04/2013|||APPR|APPROVAL FOR CHANGES TO THE INTRAOPERATIVE SYSTEM ANALYZER (ISA) SOFTWARE.
P060037|S026|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE|NJL|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2013|07/18/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH LOCATED IN  DANIKEN, SWITZERLAND.
P050034|S011|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE WIDE ANGLE 2.2XAND WIDE ANGLE 2.7X|NCJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2013|09/03/2013|||OK30|ADD AN ALTERNATE SUPPLIER OF A COMPONENT USED TO MANUFACTURE THE TELESCOPE.
P010003|S017|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2013|09/06/2013|||OK30|ADDITION OF A SERVICE SUPPLIER FOR POUCHING THE DELIVERY TIP EXTENSION.
P010068|S035|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER,|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/05/2013|||OK30|INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE.
P030031|S055|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELCIUS THERMOCOOL CATHETER,CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/05/2013|||OK30|INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE.
P040036|S039|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/05/2013|||OK30|INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE.
P950005|S045|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,,EZ STEER DS CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/05/2013|||OK30|INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE.
P990025|S038|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/05/2013|||OK30|INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE.
P990071|S024|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|BIOSENSE WEBSTER CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/05/2013|||OK30|INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE.
P010031|S393|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/03/2013|||OK30|L404 IC TEST CHANGES FOR THE DEVICES.
P980016|S432|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/03/2013|||OK30|L404 IC TEST CHANGES FOR THE DEVICES.
P060030|S034|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST VERSION 2.0, COBAS TAQMAN HCV TEST VERSION 2.0 FOR USE WITH THE HIGH PURE SYSTEM|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/06/2013|||OK30|CHANGE ROOMS FOR POSITIVE CONTROL FORMULATION AND FILLING.
P050028|S034|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PRESSURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/06/2013|||OK30|CHANGE ROOMS FOR POSITIVE CONTROL FORMULATION AND FILLING.
P110020|S008|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/06/2013|||OK30|CHANGE ROOMS FOR POSITIVE CONTROL FORMULATION AND FILLING.
P100020|S010|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/06/2013|||OK30|CHANGE ROOMS FOR POSITIVE CONTROL FORMULATION AND FILLING.
P110037|S008|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/06/2013|||OK30|CHANGE ROOMS FOR POSITIVE CONTROL FORMULATION AND FILLING.
P120019|S002|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|09/06/2013|||OK30|CHANGE ROOMS FOR POSITIVE CONTROL FORMULATION AND FILLING.
P110013|S024|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY RX ZOTAROLIMUS ELUTING CORONARY SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/09/2013|02/05/2014|||APPR|APPROVAL FOR A MODIFICATION TO THE RESIDUAL SOLVENTS ANALYTICAL TEST METHOD USED FOR THE TESTING OF THE C10 AND C19 POLYMERS, WHICH ARE A COMPONENT OF THE STENT COATING.
P080012|S019|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/09/2013|02/04/2014|||APPR|APPROVAL FOR THE ADDITION OF A CATHETER REVISION KIT FOR USE WITH THE SUBJECT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROMETRA PROGRAMMABLE IMPLANTABLE PUMP SYSTEM AND IS INDICATED FOR INTRATHECAL INFUSION OF INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE) OR PRESERVATIVE-FREE STERILE 0.9% SALINE SOLUTION (SODIUM CHLORIDE INJECTION, USP).
P080011|S027|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2013|09/06/2013|||OK30|INCREASE IN THE RANGE OF POWER FOR THE BIOFINITY SPHERE LENSES.
P890003|S284|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|REVEAL DX, REVEAL XT|OSR|CV|Real-Time Process||N|08/12/2013|10/15/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.
P010031|S394|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONSULTA CRT D, MAXIMO II CRT-D, CONCERTO II CRT -D, CONCERTO CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA XT CRT-D, V|NIK|CV|Real-Time Process||N|08/12/2013|10/15/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.
P970003|S165|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|DEMIPULSE AND DEMIPULSE DUO GENERATORS,ASPIREHC MODEL 105 GENERATOR|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2013|09/05/2013|||OK30|CHANGES TO THE AUTOMATED FUNCTIONAL TEST SOFTWARE.
P090013|S110|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process||N|08/12/2013|10/15/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.
P010015|S212|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|Real-Time Process||N|08/12/2013|10/15/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.
P900056|S125|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTALLIN ADVANCER AND CATHETER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2013|09/06/2013|||OK30|REPLACING THE SHORT DRIVE LASER WELDER USED IN THE ROTALINK ADVANCER AND CATHETER MANUFACTURING LINES.
P030024|S021|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2013|09/06/2013|||OK30|REMOVAL OF GREYZONE SAMPLES FROM A QUALITY CONTROL RELEASE TEST METHOD.
P980035|S341|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVISA, ENRHYTHM MRI|LWP|CV|Real-Time Process||N|08/12/2013|10/15/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.
P980016|S433|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR,|LWS|CV|Real-Time Process||N|08/12/2013|10/15/2013|||APPR|APPROVAL FOR A FIRMWARE UPDATE TO VERSION CM2490C_10V5 FOR THE MODEL 2490C CARELINK REMOTE HOME MONITOR AND FOR A FIRMWARE UPDATE TO VERSION CM2490G_14V2 FOR THE 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A CARDIOSIGHT READER, AND 2020B CARELINK EXPRESS MONITOR FOR THE DEVICES.
P120006|S005|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEMS|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2013|03/26/2014|||APPR|APPROVAL FOR AN ALTERNATE DELIVERY SYSTEM SHEATH SUPPLIER.
P790002|S030|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|THE BIOMET EBI BONE HEALING SYSTEM|LOF|OR|Special (Immediate Track)||N|08/13/2013|09/12/2013|||APPR|APPROVAL FOR IMPLEMENTING A COMPLIMENTARY QUALITY CONTROL PROCEDURE.
P850022|S020|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM; BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM|LOF|OR|Special (Immediate Track)||N|08/13/2013|09/12/2013|||APPR|APPROVAL FOR IMPLEMENTING A COMPLIMENTARY QUALITY CONTROL PROCEDURE.
P080006|S057|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LV LEAD|OJX|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/13/2013|12/05/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110028|S010|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/13/2013|||OK30|IMPLEMENT AN ALTERNATE SUPPLIER OF THE OUTER MEMBER AND SHEATH.
P040044|S049|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (MYNX PRODUCT FAMILY)|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|03/28/2014|||APPR|APPROVAL FOR CHANGES TO THE HYDROGEL CONDITIONING CYCLE RECIPE.
P850010|S044|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORABABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|04/08/2014|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES:  1) CLEANING VALIDATION FOR THE MICROFIBRILLAR GRINDING PROCESS EQUIPMENT; 2) ESTABLISHMENT OF DIRTY HOLD TIME;3) TOTAL ORGANIC CARBON (TOC) RECOVERY STUDY FOR SWAB AND RINSE ON STAINLESS STEEL SURFACES; AND4) TOC RECOVERY STUDY FOR SWAB AND RINSE ON TEFLON SURFACES.
P100021|S028|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/12/2013|||OK30|ALTERNATE SECOND TIER-SUPPLIER OF POLYESTER YARN AND ABILITY TO USE THE MATERIAL FROM ALL POLYESTER GRAFT MATERIAL SUPPLIERS FOR ANY OF THE STENT-GRAFT ONFIGURATIONS
P000012|S044|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/12/2013|||OK30|CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.
P110019|S052|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/13/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE PROXIMAL SHAFT ASSEMBLY.
P050028|S035|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/12/2013|||OK30|CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.
P060030|S035|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST, V 2.0 FOR USE WITH THE HIGH PURE SYSTEM|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/12/2013|||OK30|CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.
P810006|S046|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|04/08/2014|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES:  1) CLEANING VALIDATION FOR THE MICROFIBRILLAR GRINDING PROCESS EQUIPMENT; 2) ESTABLISHMENT OF DIRTY HOLD TIME;3) TOTAL ORGANIC CARBON (TOC) RECOVERY STUDY FOR SWAB AND RINSE ON STAINLESS STEEL SURFACES; AND4) TOC RECOVERY STUDY FOR SWAB AND RINSE ON TEFLON SURFACES.
P100020|S011|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/12/2013|||OK30|CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.
P110020|S009|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/12/2013|||OK30|CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.
P110037|S009|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice||N|08/14/2013|09/12/2013|||OK30|CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.
P120019|S003|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|09/12/2013|||OK30|CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.
P840062|S034|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|04/04/2014|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENT FROM METRIZYME (FORMULATED ENZYMATIC CLEANER) TO CIP-100 (FORMULATED ALKALINE CLEANER); 2) ESTABLISHMENT OF AN EQUIPMENT DIRTY HOLD TIME (DHT) OF 24-HOURS; 3) UTILIZATION OF 70% ISOPROPYL ALCOHOL (IPA), AS REQUIRED; 4) UTILIZATION OF SODIUM LAURYL SULFATE (SLS), AS REQUIRED; AND5) ESTABLISHING THE USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.
P810006|S047|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE & MICROFIBRILLAR FORM|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|04/04/2014|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENT FROM METRIZYME (FORMULATED ENZYMATIC CLEANER) TO CIP-100 (FORMULATED ALKALINE CLEANER); 2) ESTABLISHMENT OF AN EQUIPMENT DIRTY HOLD TIME (DHT) OF 24-HOURS; 3) UTILIZATION OF 70% ISOPROPYL ALCOHOL (IPA), AS REQUIRED; 4) UTILIZATION OF SODIUM LAURYL SULFATE (SLS), AS REQUIRED; AND5) ESTABLISHING THE USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.
P850010|S045|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT  ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2013|04/04/2014|||APPR|APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENT FROM METRIZYME (FORMULATED ENZYMATIC CLEANER) TO CIP-100 (FORMULATED ALKALINE CLEANER); 2) ESTABLISHMENT OF AN EQUIPMENT DIRTY HOLD TIME (DHT) OF 24-HOURS; 3) UTILIZATION OF 70% ISOPROPYL ALCOHOL (IPA), AS REQUIRED; 4) UTILIZATION OF SODIUM LAURYL SULFATE (SLS), AS REQUIRED; AND5) ESTABLISHING THE USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.
P050023|S069|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340; 500/540; 540 VR-T DX; 600/640;700/740 FAMILY, IFORIA 7/5 FAMILY; ILESTO 7/5/FAMILY|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2013|09/26/2013|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION PSW 1301.U OF THEPROGRAMMER MODELS RENAMIC AND ICS 3000 FOR THE DEVICES.
P000009|S055|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|LUMAS FAMILY|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2013|09/26/2013|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION PSW 1301.U OF THEPROGRAMMER MODELS RENAMIC AND ICS 3000 FOR THE DEVICES.
P070008|S047|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS FAMILY, EVIA FAMILY, ENTOVIS FAMILY|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2013|09/26/2013|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION PSW 1301.U OF THEPROGRAMMER MODELS RENAMIC AND ICS 3000 FOR THE DEVICES.
P980016|S435|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD. EVERA S VR ICD, EVERA XT DR ICD; EVERA XT VR ICD, PROTECTA ICD, PROCTECTA XT ICD|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/2013|10/31/2013|||APPR|APPROVAL FOR LABELING UPDATES FOR THE DEVICES.
P950037|S128|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CYLOS , PHILOS, PHILOS II, EVIA, ENTOVIS, EURO EFFECTA, ESTELLA FAMILY|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2013|09/26/2013|||APPR|APPROVAL FOR THE APPLICATION SOFTWARE VERSION PSW 1301.U OF THEPROGRAMMER MODELS RENAMIC AND ICS 3000 FOR THE DEVICES.
P040008|S007|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA (TPSA) ASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2013|09/12/2013|||OK30|REVIEW OF BIOMÉRIEUX¿S EXPANSION TO THE MANUFACTURING FACILITY IN MARCY L¿ETOILE (FRANCE).
P890064|S029|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HC2 HIGH RISK HPV DNA TEST AND DIGENE HC2 HPV DNA TEST|MAQ|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2013|04/14/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN INCORPORATED IN  GERMANTOWN, MARYLAND.
N12159|S032|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FAMILY OF ABSORBABLE HEMOSTATS|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2013|09/12/2013|||OK30|IMPLEMENT A NEW AUTOMATIC CARTONER FOR THE SURGICEL ABSORBABLE HEMOSTAT PACKAGED MATERIAL.
P010031|S396|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BRAVA CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA S CRT-D, VIVA XT CRT-D|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/2013|10/31/2013|||APPR|APPROVAL FOR LABELING UPDATES FOR THE DEVICES.
P890047|S042|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/2013|11/13/2013|||APPR|APPROVAL TO DISCONTINUE THE CURRENT INTRAVITREAL TEST AND REPLACE IT WITH THE INFLAMMATORY RELEASE ASSAY FOR THE PROVISC IBC OPHTHALMIC VISCOSURGICAL DEVICE.
P020012|S006|SUNEVA MEDICAL, INC.|5879 PACIFIC CENTER BLVD.||SAN DIEGO|CA|92121||Implant, dermal, for aesthetic use|ARTEFILL® - PMMA COLLAGEN DERMAL FILLER|LMH|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2011|02/09/2012|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SUNEVA MEDIAL, INC. IN SAN DIEGO, CALIFORNIA
P020012|S007|SUNEVA MEDICAL, INC.|5879 PACIFIC CENTER BLVD.||SAN DIEGO|CA|92121||Implant, dermal, for aesthetic use|ARTEFILL|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/07/2013|02/19/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020012|S008|SUNEVA MEDICAL, INC.|5879 PACIFIC CENTER BLVD.||SAN DIEGO|CA|92121||Implant, dermal, for aesthetic use|BELLAFILL|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/16/2013|08/27/2013|||APPR|APPROVAL FOR A CHANGE IN THE TRADE NAME OF YOUR PRODUCT FROM ARTEFILL® TO BELLAFILL®.
P110010|S058|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/16/2013|02/13/2014|||APPR|APPROVAL FOR THE ADDITION OF THE ACTIVE PHARMACEUTICAL INGREDIENT, EVEROLIMUS VARIANT 2.
P910073|S120|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTOTAK LEAD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/17/2013|||OK30|ADD A NEW PRIMARY SUPPLIER OF THE SERIAL NUMBER LABELS FOR THE DEFIBRILLATION LEADS AND CORONARY SINUS LEADS FOR THE DEVICES.
P010012|S338|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK AND ACUITY SPIRAL LEAD SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/17/2013|||OK30|ADD A NEW PRIMARY SUPPLIER OF THE SERIAL NUMBER LABELS FOR THE DEFIBRILLATION LEADS AND CORONARY SINUS LEADS FOR THE DEVICES.
P050046|S020|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE LEAD SYSTEM|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/17/2013|||OK30|ADD A NEW PRIMARY SUPPLIER OF THE SERIAL NUMBER LABELS FOR THE DEFIBRILLATION LEADS AND CORONARY SINUS LEADS FOR THE DEVICES.
P110028|S011|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2013|01/16/2014|||APPR|APPROVAL FOR A CHANGE TO THE STENT SUB-ASSEMBLY CLEANING PROCESS THAT OCCURS PRIOR TO THE ELECTROPOLISH PROCESS.
P030009|S067|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/18/2013|||OK30|CHANGE TO THE LABELING INSPECTION PROCESS.
P060033|S080|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/18/2013|||OK30|CHANGE TO THE LABELING INSPECTION PROCESS.
N17679|S036|COOPERVISION, INC.|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|TETRAFILCON LENSES: PREFERENCE SPHERE|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/13/2013|||OK30|CHANGE TO THE STERILIZATION CYCLE.
P050037|S039|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/17/2013|||OK30|CHANGE IN FLOORING MATERIAL AND ROOM CONFIGURATION IN THE MANUFACTURING ENVIRONMENT FOR A RAW MATERIAL.
P050052|S042|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/17/2013|||OK30|CHANGE IN FLOORING MATERIAL AND ROOM CONFIGURATION IN THE MANUFACTURING ENVIRONMENT FOR A RAW MATERIAL.
P960040|S303|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/19/2013|||OK30|CHANGE TO THE CAPACITOR EPOXY PROCESS FOR THE DEVICES.
P010012|S339|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/19/2013|||OK30|CHANGE TO THE CAPACITOR EPOXY PROCESS FOR THE DEVICES.
P110013|S025|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/18/2013|||OK30|CHANGE TO THE LABELING INSPECTION PROCESS.
P110011|S004|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/18/2013|||OK30|CHANGE TO THE LABELING INSPECTION PROCESS.
P080007|S018|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/17/2013|||OK30|ALTERNATE LUBRICANT FORMULATION FOR THE DELIVERY SYSTEM CATHETER TIPS.
P850079|S065|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON LENSES: FREQUENCY 55 TORIC, FREQUENCY XED TORIC XR, FREQUENCY 55 TONIC XR. METHAFILCON LENSES: HYDROSOFT XWP|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/13/2013|||OK30|CHANGE TO THE STERILIZATION CYCLE.
P960058|S104|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2013|09/18/2013|||OK30|ADDITION OF AN ALTERNATE CAPACITOR SUPPLIER.
P010015|S213|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/19/2013|||OK30|CHANGES TO THE EPOXY DISPENSE AND WELD BRACKET INSPECTION FOR THE DEVICES.
P110010|S059|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/17/2013|||OK30|USE OF AN ALTERNATE MID-SHAFT BONDING PROCESS IN THE MANUFACTURE OF THE PROMUS ELEMENT PLUS STENT DELIVERY CATHETER.
P860057|S111|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER EDWARDS PERIMOUNT PERICARDIAL AOTRIC BIOPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS, RSRTHEON|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/20/2013|||OK30|UPDATE TO THE TISSUE FIXATION SYSTEM USING A NEW AUTOMATED PROCESS.
P100041|S038|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/20/2013|||OK30|UPDATE TO THE TISSUE FIXATION SYSTEM USING A NEW AUTOMATED PROCESS.
P110021|S025|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/20/2013|||OK30|UPDATE TO THE TISSUE FIXATION SYSTEM USING A NEW AUTOMATED PROCESS.
P100034|S006|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOTTF-100A SYSTEM|NZK|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2013|09/19/2013|||OK30|CHANGE TO THE MANUFACTURING PRODUCTION FLOW TO INCLUDE DISTRIBUTION LOGISTICS THAT WILL BE PERFORMED BY NOVOCURE GMBH IN ROOT LUZERN, SWITZERLAND.
P060002|S033|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2013|09/16/2013|||OK30|ALTERNATE TIP CLEANING PROCESS.
P980035|S342|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2013|09/12/2013|||OK30|ADDITION OF A LASER WELDER AT THE BATTERY SUPPLIER.
P010015|S214|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P , SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2013|09/12/2013|||OK30|ADDITION OF A LASER WELDER AT THE BATTERY SUPPLIER.
P090013|S111|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2013|09/12/2013|||OK30|ADDITION OF A LASER WELDER AT THE BATTERY SUPPLIER.
P100044|S011|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2013|09/18/2013|||OK30|ADD A NEW LABELING SUPPLIER FOR THE DEVICE.
P030017|S177|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2013|09/20/2013|||OK30|UPDATE THE TEST SOFTWARE FOR CHECKING THE BATTERY PROFILE OF THE IMPLANTABLE PULSE GENERATOR.
P060027|S053|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/2013|03/06/2014|||APPR|APPROVAL FOR:1) A FIRMWARE PATCH FOR THE IMPLANTABLE DEVICE WITH THE MICROPROCESSOR (UP) V4B; 2) A NEW FIRMWARE VERSION FOR THE UP V4C AND V4D; 3) THE HARDWARE MODIFICATIONS FOR THE IMPLANTABLE DEVICES; 4) THE UPDATES/ MODIFICATIONS FOR THE PROGRAMMER APPLICATION SOFTWARE; AND 5) THE UPDATES/ MODIFICATIONS FOR THE REMOTE MONITORING SYSTEM (RMS).
P980049|S085|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|SMARTVIEW REMOTE MONITORING SYSTEM: SMARTVIEW MONITOR PSTN MODEL, GPRS MODEL|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/21/2013|03/06/2014|||APPR|APPROVAL FOR:1) A FIRMWARE PATCH FOR THE IMPLANTABLE DEVICE WITH THE MICROPROCESSOR (UP) V4B; 2) A NEW FIRMWARE VERSION FOR THE UP V4C AND V4D; 3) THE HARDWARE MODIFICATIONS FOR THE IMPLANTABLE DEVICES; 4) THE UPDATES/ MODIFICATIONS FOR THE PROGRAMMER APPLICATION SOFTWARE; AND 5) THE UPDATES/ MODIFICATIONS FOR THE REMOTE MONITORING SYSTEM (RMS).
P050037|S040|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORARION AND OR/ CORRECTION OF THE SIGNS OF FACIAL FAT LO|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2013|09/16/2013|||OK30|CHANGE IN THE STERILIZATION RACK CONFIGURATION.
P050052|S043|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE  IMPLANT FOR SUB-DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FO|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2013|09/16/2013|||OK30|CHANGE IN THE STERILIZATION RACK CONFIGURATION.
P890055|S049|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/22/2013|09/20/2013|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO PROVIDE USERS WITH INFORMATION REGARDING STEPS THAT SHOULD BE TAKEN TO PREVENT A POTENTIAL ADVERSE REACTION WHEN FILLING THE PUMP RESERVOIR.
P900009|S036|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN ULTRASOUND BONE HEALING SYSTEM|LPQ|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2013|05/07/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE IN CORDOVA, TENNESSEE.
P000043|S022|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|THERMATRX OFFICE THERMOTHERAPY SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2013|09/18/2013|||OK30|CHANGE IN STERILIZATION MONITORING PROCESS, CHANGE IN THE ORDER OF LABELING, AND CHANGE IN POUCH ORIENTATION.
P890003|S285|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR, DEVICE DATA MANAGEMENT APPLICATION, APPLICATION SOFTWARE|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2013|02/14/2014|||APPR|APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
P980016|S436|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD, INTRINSIC 30ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, VR ICD, EVERA S DR ICD, S VR ICD,XT VR ICD, MAXIMO|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2013|02/14/2014|||APPR|APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
P980035|S343|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, DR MRI IPG, ENPULSE EL IPG, E2 IPG, ENRHYTHM IPG, KAPPA D IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2013|02/14/2014|||APPR|APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
P010015|S215|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2013|02/14/2014|||APPR|APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
P010031|S397|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD, MAXIMO ICD, BRAVA CRT-D, CONCERTO ICD, II CRT-D, CONSULTA ICD, MAXIM|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2013|02/14/2014|||APPR|APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
P980022|S136|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/23/2013|09/13/2013|||APPR|APPROVAL OF LABELING CHANGES TO THE USER GUIDE FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, AND MMT-722K), AND FOR THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEMS.
P030017|S178|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2013|09/20/2013|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER FOR THE PRINTED CIRCUIT BOARD.
P090013|S112|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/23/2013|02/14/2014|||APPR|APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
P940015|S028|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC AND SYNVISC-ONE|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2013|05/20/2014|||APPR|APPROVAL FOR CHANGES TO QUALITY CONTROL TEST METHODS.
P960043|S084|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE, PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2013|09/25/2013|||OK30|REMOVING A REDUNDANT INSPECTION FOR BLEEDBACK LUMEN PATENCY FROM THE MANUFACTURING PROCESS.
P860057|S112|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2013|09/23/2013|||OK30|CHANGING THE SILICONE GASKET MATERIAL (SUPPLIED BY ST. GOBAIN) FOR THE 3.8 OZ. JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR ALL EDWARDS HEART VALVES.
P010041|S044|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2013|09/23/2013|||OK30|CHANGING THE SILICONE GASKET MATERIAL (SUPPLIED BY ST. GOBAIN) FOR THE 3.8 OZ. JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR ALL EDWARDS HEART VALVES.
P120006|S006|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRIVASCULAR, INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2013|09/24/2013|||OK30|NEW VENDOR OF THE RESIN MATERIAL FOR THE MOLDED LUER COMPONENTS IN THE FILL POLYMER KIT.
P980022|S137|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL TIME INSULIN PUMP, PARADIGN REAL TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2013|09/24/2013|||OK30|ADDITION OF AN ALTERNATE FACILITY WAREHOUSE SPACE FOR THE HANDLING OF RAW MATERIALS INCLUDING SUBASSEMBLIES AND COMPONENTS FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-522, MMT-522K, MMT-722, MMT-722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-523, MMT-523K, MMT-723, MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEM.
P090022|S019|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2013|09/19/2013|||OK30|ADDITION OF TWO NEW POUCH SEALERS.
P070026|S019|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|08/26/2013|10/24/2013|||APPR|ADDITION OF A TAMP EXTRACTOR INSTRUMENT.
P870077|S055|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LOW|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2013|09/23/2013|||OK30|CHANGING THE SILICONE GASKET MATERIAL (SUPPLIED BY ST. GOBAIN) FOR THE 3.8 OZ. JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR ALL EDWARDS HEART VALVES.
P000007|S042|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2013|09/23/2013|||OK30|CHANGING THE SILICONE GASKET MATERIAL (SUPPLIED BY ST. GOBAIN) FOR THE 3.8 OZ. JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR ALL EDWARDS HEART VALVES.
P870056|S061|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2013|09/23/2013|||OK30|CHANGING THE SILICONE GASKET MATERIAL (SUPPLIED BY ST. GOBAIN) FOR THE 3.8 OZ. JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR ALL EDWARDS HEART VALVES.
P910023|S321|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ELLIPSE FAMILY OF ICDS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/25/2013|12/17/2013|||APPR|APPROVAL FOR A MODIFICATION TO THE OUTPUT FLEX ASSEMBLY IN THE ELLIPSE FAMILY OF ICDS.
P030017|S179|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2013|09/26/2013|||OK30|CHANGE THE SOLDER FILLET HEIGHT REQUIREMENT FOR THE PRINTED CIRCUIT BOARD ASSEMBLY.
P100005|S003|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|M-VU ALGORITHM ENGINE|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/2013|12/02/2013|||APPR|APPROVAL FOR M-VU ALGORITHM ENGINE VERSION 3.0.0.0.
P070014|S040|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2013|09/26/2013|||OK30|ADDITIONAL DIMENSIONAL MEASURING MACHINE FOR QUALITY CONTROL INSPECTIONS.
P100041|S039|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/2013|09/23/2013|||APPR|APPROVAL FOR REMOVAL OF ACCESS APPROACH FROM DEVICE LABELING. THE DEVICE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION > 20% WHO HAVE BEEN EXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TO BE: 1) INOPERABLE AND IN WHOM EXISTING CO-MORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM CORRECTION OF THE AORTIC STENOSIS; OR 2) BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A PREDICTED OPERATIVE RISK SCORE >= 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >= 15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT.
P110021|S026|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/2013|09/23/2013|||APPR|APPROVAL FOR REMOVAL OF ACCESS APPROACH FROM DEVICE LABELING. THE DEVICE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION > 20% WHO HAVE BEEN EXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TO BE: 1) INOPERABLE AND IN WHOM EXISTING CO-MORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM CORRECTION OF THE AORTIC STENOSIS; OR 2) BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A PREDICTED OPERATIVE RISK SCORE >= 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >= 15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT.
P050047|S032|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2013|09/06/2013|||OK30|CHANGE THE HYALURONIC ACID (HA) CONCENTRATION DURING A MANUFACTURING PROCESS.
P830055|S137|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice||N|08/28/2013|09/27/2013|||OK30|CHANGE TO A CERTAIN VISUAL INSPECTION PROCESSES USED IN PRODUCTION OF THE DEVICE.
P080027|S013|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2013|09/26/2013|||OK30|CHANGE TO UTILIZE A SEMI-AUTOMATED PROCESS FOR ASSEMBLY OF THE TEST DEVICE COMPONENT AND POUCHING OF THE KIT COMPONENTS.
P920047|S059|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER,BLAZER II HTD, AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P060006|S048|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS  SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P050019|S017|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P020009|S109|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P950020|S064|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|FLEXTOME CUTTINGG BALLOON DILATATION DEVICE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P980003|S040|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P100023|S077|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P110035|S019|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
N970003|S155|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSAR, PULSAR MAX, INSIGNIA, ALTRUA, ADVANTIO, INGENIO|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P010012|S340|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD, EASYTRAK, LIVIAN, COGNIS, AND ACUITY SPIRAL, ENERGEN CRT-D, PUNCTUA CRT-D, INCEPTA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P030005|S102|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR AND INVIVE CRT-P SYSTEMS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P050046|S021|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE LEAD SYSTEM|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P840068|S053|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DELTA/ VISTA|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P890061|S023|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P AICD SYSTEMS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P910073|S121|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P110012|S004|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT|OWE|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|01/24/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT LEICA BIOSYSTEMS IN SOLON MILLS, ILLINOIS.
P030052|S012|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|01/24/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT LEICA BIOSYSTEMS IN SOLON MILLS, ILLINOIS.
P090003|S027|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P020025|S043|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES, AND BLAZER II XP, BLAZER PRIME XP ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P110010|S060|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS ELUTING PLATINUM STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P900056|S126|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTALIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P910077|S137|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND VENTAK MINI AICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P060008|S106|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS  LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P930035|S025|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AICD SYSTEMS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P830026|S082|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COSMOS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P940031|S075|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR/SR,DISCOVERY,MERIDIAN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P040016|S115|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX  (LIBERTE)  BARE METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P950001|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE LEAD SYSTEM|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P960006|S040|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX,SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEMS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P830060|S076|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P960004|S063|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P940019|S040|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT LLIAC ENDOPROSTHESIS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P960040|S304|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV AND VENTAK PRIZM DR/VR,VITALITY,CONFIENT,TELIGEN,PUNCTUA ICD,ENERGEN ICD,AND INCEPTA ICD AICD SYSTEMS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/25/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P930031|S047|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P980033|S036|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT  VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2013|09/27/2013|||OK30|P050019/S0179/27/13	CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS PGSOOOS CHILLI II® COOLED ABLATION CATHETER, MODEL8005 CIRCUCOOL PUMP, MODEL2104 TUBINGKIT, STERILE CABLES 	BOSTON SCIENTIFIC CORPORATION MAPLE GROVE MN 55311	USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
P040020|S050|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS|MFK|OP|Panel Track||N|08/30/2013|04/13/2015|15M-1325|04/29/2015|APPR|APPROVAL FOR THE ACRYSOF® IQ RESTOR® +2.5 D MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL SV25T0. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLEINDEPENDENCE.
P020055|S009|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|10/02/2013|||OK30|ADD A SUPPLIER (ROCHE, PENZBERG) OF A COMPONENT (STREPTAVIDIN HORSERADISH PEROXIDASE) FOR THE IVIEW DAB DETECTION KIT.
P080004|S014|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|I SERT MODEL 251  PRELOADED POSTERIOR CHAMBER INTRACULAR LENS; I SERT MODEL 250 PRELOADED POSTER CHANBER INTRAOCULAR LEN|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|09/26/2013|||OK30|CHANGE IN MATERIAL FOR A MANUFACTURING FIXTURE USED DURING THE POST-TUMBLING FINAL WASHING PROCESS.
P990081|S022|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|10/02/2013|||OK30|ADD A SUPPLIER (ROCHE, PENZBERG) OF A COMPONENT (STREPTAVIDIN HORSERADISH PEROXIDASE) FOR THE IVIEW DAB DETECTION KIT.
P040014|S020|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|09/27/2013|||OK30|ADDITIONAL STERILIZATION CHAMBER FOR THE THERAPY SERIES ABLATION CATHETERS.
P040042|S025|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|09/27/2013|||OK30|ADDITIONAL STERILIZATION CHAMBER FOR THE THERAPY SERIES ABLATION CATHETERS.
P110042|S015|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|30-Day Notice||N|08/30/2013|09/25/2013|||OK30|EXPAND RECEIVING AND INSPECTION ACTIVITIES FOR CERTAIN S-ICD® COMPONENTS AND ACCESSORIES TO BOSTON SCIENTIFIC¿S FACILITY LOCATED IN ST. PAUL, MINNESOTA.
P060019|S024|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|09/27/2013|||OK30|ADDITIONAL STERILIZATION CHAMBER FOR THE THERAPY SERIES ABLATION CATHETERS.
P110019|S053|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/30/2013|02/28/2014|||APPR|APPROVAL FOR AN UPDATE TO THE LABELING TO REFLECT THE THREE YEAR POST APPROVAL STUDY FINDINGS FROM THE SPIRIT PRIME CLINICAL TRIAL.
P110016|S009|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH DUO AND SAFIRE BLU DUO ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|09/27/2013|||OK30|ADDITIONAL STERILIZATION CHAMBER FOR THE THERAPY SERIES ABLATION CATHETERS.
P890055|S050|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|09/23/2013|||OK30|REMOVAL OF A DUPLICATE VISUAL INSPECTION PERFORMED ON TWO ACCESSORY COMPONENTS PACKAGED WITH THE MEDSTREAM INTRATHECAL CATHETER.
P890055|S051|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2013|09/27/2013|||OK30|MANUFACTURING CHANGE TO THE BONDING OPERATION OF THE MEDSTREAM PUMP SUB-ASSEMBLY.
P010030|S044|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2013|10/03/2013|||OK30|FOUR MANUFACTURING CHANGES RELATED TO THE LIFEVEST 4000 AUTO TEST FIXTUREUSED TO AUTOMATE THE FUNCTIONALITY TESTING OF THE DEVICE.
P100030|S002|MALLINCKRODT PHARMA IP TRADING DAC|DAMASTOWN INDUSTRIAL ESTATE||MULHUDDART||||Sealant,polymerizing|ARTERX SURGICAL SEALANT,|NBE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/03/2013|11/05/2013|||APPR|APPROVAL TO EXTEND THE SHELF LIFE FOR ARTERX SURGICAL SEALANT FROM 12 MONTHS TO 24 MONTHS WHEN STORED AT2-8C AND TO EXTEND THE SHELF LIFE FOR THE ARTERX DELIVERY TIPS FROM 12 MONTHS TO 42 MONTHS.
P010031|S398|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2013|10/29/2013|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE IN THE MULTILAYER CERAMIC CAPACITORS MADE BY A SECOND TIER SUPPLIER WHICH ARE USED IN THE DEVICES.
P980016|S437|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2013|10/29/2013|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE IN THE MULTILAYER CERAMIC CAPACITORS MADE BY A SECOND TIER SUPPLIER WHICH ARE USED IN THE DEVICES.
P960040|S305|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA,ENERGEN AND PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2013|09/26/2013|||OK30|IMPLEMENTATION OF A VACUUM BASED SYSTEM AT A SUPPLIER TO ELIMINATE CONTAMINATES IN THE CAVITIES OF THE PULSE GENERATOR HEADERS.
P080023|S022|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2013|09/27/2013|||OK30|ADDITION OF ALTERNATE SUPPLIERS FOR ANTI-HBC POSITIVE PLASMA.
P980035|S344|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2013|09/26/2013|||OK30|EXPAND THE HYBRID LOT IDENTIFICATION (ID) CHARACTER FORMAT.
P110042|S016|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/2013|10/31/2013|||APPR|APPROVAL FOR A SUPPLIER CHANGE FOR THE HIGH VOLTAGE CAPACITORS USED IN THE S-ICD SYSTEM.
P110042|S017|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2013|04/02/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CAMERON HEALTH, INC., A SUBSIDIARY OF BOSTON SCIENTIFIC CORPORATION, IN TIPPERARY, IRELAND.
P100030|S001|MALLINCKRODT PHARMA IP TRADING DAC|DAMASTOWN INDUSTRIAL ESTATE||MULHUDDART||||Sealant,polymerizing|ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES|NBE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/2013|11/25/2013|||APPR|APPROVAL FOR THE ADDITION OF 2.5ML AND 5.0ML FILL VOLUMES TO THE EXISTING 4.0ML FILL VOLUME, USING THE SAME 5ML SYRINGE AND PACKAGING.
P910001|S067|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2013|10/02/2013|||OK30|SUPPLIER CHANGE FOR THE PRINTED CIRCUIT BOARD ASSEMBLIES.
P960030|S038|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ISOFLEX FAMILY OF LEADS (1944,1948)|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2013|10/02/2013|||OK30|IMPLEMENTATION OF AN AUTOMATED LEAD TESTER (ALT) DURING MANUFACTURING OF THE LEAD FAMILIES.
P960013|S076|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL AND OPTISENSE FAMILY OF LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2013|10/02/2013|||OK30|IMPLEMENTATION OF AN AUTOMATED LEAD TESTER (ALT) DURING MANUFACTURING OF THE LEAD FAMILIES.
P880086|S235|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2013|10/02/2013|||OK30|ADDITION OF A VISUAL INSPECTION DURING THE ASSEMBLY OF THE ACCENT AND ANTHEM FAMILY OF DEVICES.
P030035|S113|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM CRT-PS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2013|10/02/2013|||OK30|ADDITION OF A VISUAL INSPECTION DURING THE ASSEMBLY OF THE ACCENT AND ANTHEM FAMILY OF DEVICES.
P020047|S054|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|09/05/2013|10/04/2013|||OK30|CHANGE TO THE STENT DISLODGEMENT TESTING SAMPLING PLAN.
P790005|S050|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN BONE GROWTH STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2013|10/03/2013|||OK30|USE OF A NEW WATER SYSTEM MONITORING TEST METHOD.
P850035|S036|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF IMPLANTABLE SPINAL FUSION STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2013|10/03/2013|||OK30|USE OF A NEW WATER SYSTEM MONITORING TEST METHOD.
P010031|S399|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2013|10/02/2013|||OK30|SOFTWARE UPDATES TO THE LASER WELD PROCESS FOR THE CAPACITORS USED IN THE VIVA, BRAVA, AND EVERA FAMILY OF DEVICES.
P980016|S438|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2013|10/02/2013|||OK30|SOFTWARE UPDATES TO THE LASER WELD PROCESS FOR THE CAPACITORS USED IN THE VIVA, BRAVA, AND EVERA FAMILY OF DEVICES.
P080027|S014|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2013|10/03/2013|||OK30|CHANGE TO AN INCOMING RAW MATERIAL SPECIFICATION.
P010015|S217|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INSYNC; INSYNC III; ATTAIN LEAD; ATTAIN OTW LEAD|NKE|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|09/06/2013|02/27/2014|||APPR|APPROVAL FOR A LABELING UPDATE TO INCLUDE THE RESULTS FROM THE POST-APPROVAL STUDY, SPECIFICALLY THE MEDTRONIC INSYNC REGISTRY POST APPROVAL STUDY
P840001|S247|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/03/2013|||OK30|UPDATES TO THE CURRENT FINAL PACKLABEL PRINTING EQUIPMENT CONTROLLER, WHICH IS USED DURING THE STERILE FINAL PACKAGE OPERATION ATMEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) IN VILLALBA, PUERTO RICO.
P960009|S179|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS EXTENSIONS, DBS LEADS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/03/2013|||OK30|UPDATES TO THE CURRENT FINAL PACKLABEL PRINTING EQUIPMENT CONTROLLER, WHICH IS USED DURING THE STERILE FINAL PACKAGE OPERATION ATMEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) IN VILLALBA, PUERTO RICO.
P020004|S087|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER AAA ENDOPROSTHESIS SIM-PULL|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/08/2013|||OK30|DUPLICATION OF THE CURRENT COMBINED SIM-PULL AND C3 CATHETER MANUFACTURING PROCESS; ADDITION OF A NEW ISO 8 CLEANROOM AT AN ALREADY APPROVED FACILITY; AND MACHINERY ANDRECIPES UPGRADES AT BOTH APPROVED MANUFACTURING FACILITIES.
P080025|S054|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL EXTENSIONS, SNS BOWEL LEADS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/03/2013|||OK30|UPDATES TO THE CURRENT FINAL PACKLABEL PRINTING EQUIPMENT CONTROLLER, WHICH IS USED DURING THE STERILE FINAL PACKAGE OPERATION ATMEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) IN VILLALBA, PUERTO RICO.
P970004|S158|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY EXTENSIONS, SNS URINARY LEADS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/03/2013|||OK30|UPDATES TO THE CURRENT FINAL PACKLABEL PRINTING EQUIPMENT CONTROLLER, WHICH IS USED DURING THE STERILE FINAL PACKAGE OPERATION ATMEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) IN VILLALBA, PUERTO RICO.
P920047|S060|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2013|10/07/2013|||APPR|APPROVAL FOR IEC 60601-1 3RD EDITION LABELING IMPLEMENTATION TO THE BLAZER II, BLAZER II XP/HTD, BLAZER PRIME XP/HTD AND CHILLI II CARDIAC ABLATION CATHETERS AND CABLES.
P020025|S044|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000XP CARDIAC ABLATION SYSTEM|OAD|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2013|10/07/2013|||APPR|APPROVAL FOR IEC 60601-1 3RD EDITION LABELING IMPLEMENTATION TO THE BLAZER II, BLAZER II XP/HTD, BLAZER PRIME XP/HTD AND CHILLI II CARDIAC ABLATION CATHETERS AND CABLES.
P980003|S041|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION SYSTEM|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2013|10/07/2013|||APPR|APPROVAL FOR IEC 60601-1 3RD EDITION LABELING IMPLEMENTATION TO THE BLAZER II, BLAZER II XP/HTD, BLAZER PRIME XP/HTD AND CHILLI II CARDIAC ABLATION CATHETERS AND CABLES.
P000012|S045|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
P850064|S025|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|09/24/2013|||OK30|CHANGE TO THE LIFEPORT TEST FIXTURE.
P050028|S036|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|AMPHLIPRE/COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
P060030|S036|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
P110037|S010|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
P000012|S046|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
P990046|S036|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2013|10/09/2013|||OK30|NEW PIECE OF EQUIPMENT INTENDED FOR AUTOMATED INSPECTION OF THE MECHANICAL VALVE SUBASSEMBLY.
P030004|S008|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX 18LES & ONYX 34 LES|MFE|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|ADD AN ALTERNATE SUPPLIER FOR PYROGEN TESTING.
P050028|S037|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
P060030|S037|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
P110037|S011|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2013|10/09/2013|||OK30|CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
P980016|S439|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2013|10/10/2013|||OK30|UPDATE TO THE SONOSCAN ACCEPTANCE CRITERIA INSPECTION PROCESS.
P010031|S400|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2013|10/10/2013|||OK30|UPDATE TO THE SONOSCAN ACCEPTANCE CRITERIA INSPECTION PROCESS.
P000057|S007|INTEGRA LIFESCIENCES CORPORATION|8900 CAMERON ROAD||AUSTIN|TX|78754||Finger semi-constrained pyrolytic carbon uncemented prosthesis|ASCENSION MCP|NEG|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/10/2013|03/06/2014|||APPR|APPROVAL FOR A CHANGE IN PACKAGING.
P980035|S345|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG,ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2013|10/10/2013|||OK30|ADDITION OF A DUPLICATE BATTERY ELECTROLYTE FILL STATION.
P010015|S218|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2013|10/10/2013|||OK30|ADDITION OF A DUPLICATE BATTERY ELECTROLYTE FILL STATION.
P090013|S113|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2013|10/10/2013|||OK30|ADDITION OF A DUPLICATE BATTERY ELECTROLYTE FILL STATION.
P010031|S401|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2013|10/10/2013|||OK30|TWO NEW REWORK PROCESSES FOR THE DEVICES.
P100010|S031|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT AND ARCTIC FRONT  ADVANCE CRYOABLATION CATHETERS|OAE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2013|03/19/2014|||APPR|APPROVAL FOR A CHANGE IN THE EQUIPMENT USED TO PERFORM IN PROCESS TESTING OF THE PRESSURE SENSOR INTEGRATED IN THE BLOOD DETECTOR BOARD, THE LEAK DETECTOR WIRE, AND THE THERMOCOUPLES AND REMOVAL OF A REDUNDANT UPSTREAM TESTING OF THE PRESSURE SENSOR FUNCTION.
P980016|S440|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2013|10/10/2013|||OK30|TWO NEW REWORK PROCESSES FOR THE DEVICES.
P950029|S083|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR,REPLY DR,ESPRIT SR,ESPRIT DR|NVZ|CV|30-Day Notice||N|09/11/2013|09/26/2013|||OK30|CHANGE IN THE TEST METHODOLOGY EMPLOYED DURING BENCH TESTING OF THE COMPONENTS AND FINISHED DEVICE.
P980049|S086|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750,PARADYM DR8750,PARADYM RF VR 9750,PARADYM RF DR 9750|MRM|CV|30-Day Notice||N|09/11/2013|09/26/2013|||OK30|CHANGE IN THE TEST METHODOLOGY EMPLOYED DURING BENCH TESTING OF THE COMPONENTS AND FINISHED DEVICE.
P060027|S054|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750,PARADYM RF CRT-D9750|NIK|CV|30-Day Notice||N|09/11/2013|09/26/2013|||OK30|CHANGE IN THE TEST METHODOLOGY EMPLOYED DURING BENCH TESTING OF THE COMPONENTS AND FINISHED DEVICE.
P950029|S084|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR,REPLY DR,ESPRIT SR,ESPRIT DR|NVZ|CV|30-Day Notice||N|09/11/2013|10/02/2013|||OK30|CHANGE TO THE ROUTINE BIOBURDEN MONITORING BEFORE STERILIZATION.
P980049|S087|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750,PARADYM DR8750,ISOLINE 2CT-ISOLINE 2CR|MRM|CV|30-Day Notice||N|09/11/2013|10/02/2013|||OK30|CHANGE TO THE ROUTINE BIOBURDEN MONITORING BEFORE STERILIZATION.
P060027|S055|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750,PARADYM RF CRT-D9750,SITUS OTW UW28D|NIK|CV|30-Day Notice||N|09/11/2013|10/02/2013|||OK30|CHANGE TO THE ROUTINE BIOBURDEN MONITORING BEFORE STERILIZATION.
P020030|S010|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Permanent defibrillator electrodes|STELID II BTF/BJF - STELIX II BRF|NVY|CV|30-Day Notice||N|09/11/2013|10/02/2013|||OK30|CHANGE TO THE ROUTINE BIOBURDEN MONITORING BEFORE STERILIZATION.
P010013|S049|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2013|10/10/2013|||OK30|INSTALLATION OF NEW EQUIPMENT USED IN THE TESTING OF THE NOVASURE RF CONTROLLER UNITS.
P010013|S050|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/11/2013|11/08/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100027|S011|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|10/10/2013|||OK30|ADDITION OF A NEW SUPPLIER OF TWO BIOCONJUGATES FOR THE ULTRAVIEW SISH DNP DETECTION KIT AND THE ULTRAVIEW RED ISH DIG DETECTION KIT. BOTH DETECTION KITS ARE PARTS OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL.
P020025|S045|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP RF ABLATION SYSTEM|OAD|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|11/25/2013|||APPR|APPROVAL TO ALLOW HEALTH CARE FACILITIES TO MANUALLY CLEAN AND RE-STERILIZE THE INTELLATIP MIFI XP CABLE UP TO 10 TIMES VIA ETHYLENE OXIDE OR STEAM AFTER INITIAL USE OF THE CABLES.
P110002|S001|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/12/2013|05/27/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020025|S046|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000 XP RF ABLATION SYSTEM|OAD|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/12/2013|11/25/2013|||APPR|APPROVAL TO CHANGE THE SHELF LIFE OF THE INTELLATIP MIFI XP ABLATION CATHETER FROM 6 MONTHS TO 3 YEARS.
P020024|S040|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER II|MAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/11/2013|11/08/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S113|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER - EDEARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|10/11/2013|||OK30|ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.
P010041|S045|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|10/11/2013|||OK30|ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.
P070026|S020|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/12/2013|12/09/2013|||APPR|APPROVAL FOR THE ADDITION OF TRI-LOCK BPS HIP STEM TO BE USED WITH THE 36MM FEMORAL HEADS.
P870056|S062|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER- EDWARDS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|10/11/2013|||OK30|ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.
P870077|S056|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARTENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|10/11/2013|||OK30|ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.
P110009|S001|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROTHESIS|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/12/2013|05/19/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000007|S043|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|10/11/2013|||OK30|ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.
P100041|S040|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES-RETROFLEX 3 DELIVERY SYSTEM, EDWARDS TRANSFEMORAL BALLOON CATHE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|10/11/2013|||OK30|ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.
P110002|S002|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/12/2013|06/03/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110021|S027|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, CRIMPER ASCENDRA BALLOON CATHETER|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2013|10/11/2013|||OK30|ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.
P110009|S002|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Special (Immediate Track)|Postapproval Study Protocol - OSB|N|09/12/2013|05/08/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY
N970003|S156|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO, FORMIO, INVIVE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|ADDITION OF NEW CLEANERS AND CLEANING SOLUTION FOR THE PULSE GENERATOR (PG) FEEDTHRU ASSEMBLY PROCESS.
P920015|S116|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE,SQ,SPRINT AND SPRINT FIDELIS LEAD MODELS AND ACCESSORIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|ADDITION OF AN ELLIPSOMETRY INSPECTION STEP FOR ETFE JACKETED WIRE AND CABLE COMPONENTS.
P030036|S061|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|ADDITION OF AN ELLIPSOMETRY INSPECTION STEP FOR ETFE JACKETED WIRE AND CABLE COMPONENTS.
P840001|S248|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|NEW MATERIALS FOR THE INTEGRATED CIRCUIT COMPONENT.
P860004|S195|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED DRUG PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|NEW MATERIALS FOR THE INTEGRATED CIRCUIT COMPONENT.
P950005|S046|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, CELSIUS RMT THERMOCOOL|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/09/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
P030031|S057|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/09/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
P040036|S040|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SF|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/09/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.
P940016|S016|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|H.E.L.P. PLASMAT FUTURA SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/13/2013|08/11/2015|||APPR|APPROVAL FOR THE H.E.L.P. OPTIMIZED THERAPY (HOT) CONFIGURATION
P030005|S103|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INTUA|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|ADDITION OF NEW CLEANERS AND CLEANING SOLUTION FOR THE PULSE GENERATOR (PG) FEEDTHRU ASSEMBLY PROCESS.
P080020|S006|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/11/2013|||OK30|MANUFACTURING LOCATION CHANGES WITHIN THE CURRENT FACILITIES.
P940010|S011|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY|OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)|MVG|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/13/2013|03/21/2014|||APPR|APPROVAL FOR:1) A CHANGE IN THE MATERIAL OF THE TUBING CAP PLACED OVER THE DIFFUSER TIP FROM A POLYCARBONATEMATERIAL TO AN ETFE TUBING MATERIAL;2) THE USE OF HEAT BONDING FOR THE ETFE TUBING MATERIAL IN PLACE OF THE ADHESIVE BONDING PRESENTLY USED FOR THE TUBING CAP;3) ELIMINATION OF THE ORANGE SHEATH PRESENTLY ADDED OVER THE INACTIVE LENGTH OF THE PRESENTLYMARKETED FIBER OPTIC DIFFUSERS; AND4) MODIFICATION OF THE DIFFUSER TIP, SPECIFICALLY:A) USE OF A SILVER MIRROR TO REPLACE THE DIELECTRIC MATERIAL PRESENTLY USED;B) THE USE OF A SILICON DIFFUSER MIX BETWEEN THE END OF THE FIBER CORE AND DIELECTRIC MIRROR;C) AND THE ADDITION OF DIFFUSER SHRINK TUBING TO THE DISTAL END.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPTIGUIDE FIBER OPTIC DIFFUSERDCYL 700 SERIES AND IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN(PORFIMER SODIUM) FOR INJECTION FOR: 1) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER OR PATIENTS WITH PARTIALLYOBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIAN, CANNOT BE SATISFACTORILYTREATED WITH ND:YAG LASER THERAPY;2) REDUCTION OF OBSTRUCTION AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLYOBSTRUCTING ENDOBRONCHIAL NONSMALL CELL LUNG CANCER (NSCLC);3) TREATMENT OF MICROINVASIVE ENDOBRONCHIAL NSCLC IN PATIENTS FOR WHOM SURGERY AND RADIOTHERAPY ARE NOT INDICATED; AND4) ABLATION OF HIGH-GRADE DYSPLASIA (HGD) IN BARRETTS ESOPHAGUS (BE) AMONG PATIENTS WHO ARE NOT CANDIDATES FOR ESOPHAGECTOMY.
P060039|S049|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LV LEAD|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/13/2013|11/19/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960009|S180|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|NEW MATERIALS FOR THE INTEGRATED CIRCUIT COMPONENT.
P970004|S159|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|NEW MATERIALS FOR THE INTEGRATED CIRCUIT COMPONENT.
P080025|S055|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR BOWEL CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2013|10/10/2013|||OK30|NEW MATERIALS FOR THE INTEGRATED CIRCUIT COMPONENT.
P920015|S117|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE,SQ,SPRINT AND SPRINT FIDELIS LEAD MODELS AND ACCESSORIES|LWS|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/13/2013|11/22/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010031|S402|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS|NIK|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/13/2013|11/22/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980016|S441|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/13/2013|11/22/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040037|S055|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2013|10/04/2013|||OK30|USE OF AN ALTERNATE POLYTETRAFLUORO-ETHYLENE (PTFE) RESIN RAW MATERIAL AND AN ALTERNATE MANUFACTURING AID DURING THE OVERWRAP PROCESS.
P040027|S032|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2013|10/04/2013|||OK30|USE OF AN ALTERNATE POLYTETRAFLUORO-ETHYLENE (PTFE) RESIN RAW MATERIAL AND AN ALTERNATE MANUFACTURING AID DURING THE OVERWRAP PROCESS.
P840001|S249|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRIMEADVANCED SURESCAN MRI NEUROSTIMULATOR,RESTOREULTRA SURESCAN MRI NEUROSTIMULATOR,RESTOREADVANCED SURESCAN MRI NEUROS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2013|10/15/2013|||OK30|MODIFICATIONS TO THE TEST SAMPLE SIZE FOR CERTAIN CONNECTOR COMPONENTS RECEIVED FROM A COMPONENT SUPPLIER.
P010015|S219|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD,LEFT VENTICULAR PACING LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P030036|S062|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P060039|S050|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P090013|S114|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P830061|S097|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P850089|S100|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P090006|S011|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2013|10/17/2013|||OK30|MODIFY THE BONDING PROCESS FOR THE STABILITY MEMBER SUBCOMPONENT OF THE DELIVERY SYSTEM.
P120005|S011|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/16/2013|06/03/2014|||APPR|APPROVAL FOR THE G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM, THAT INCLUDES THE DEXCOM G4 PLATINUM PROFESSIONAL RECEIVER SHIELD, TO ALLOW MULTIPLE PATIENT USE OF THE SYSTEM BY A HEALTHCARE PROFESSIONAL. THE DEVICE, AS MODIFIED, WILL BE MARKETEDUNDER THE TRADE NAME G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED FOR:THE DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR MULTIPLE PATIENT USE AND REQUIRES PURCHASE BY A HEALTHCARE PROVIDER. THE SYSTEM IS NOT INTENDED FOR USE IN A HOSPITAL SETTING.THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES.THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE G4 PLATINUM PROFESSIONAL SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERALSEQUENTIAL READINGS OVER TIME.
P990040|S017|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2013|12/24/2013|||APPR|APPROVAL TO CHANGE THE SUPPLIER FOR A CHEMICAL COMPOSITION TEST.
P020055|S010|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY|NKF|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/11/2013|06/13/2014|||APPR|APPROVAL FOR ADDITION OF A NEW SUPPLIER FOR PRODUCTION OF THE BULK RAW MATERIAL AND FOR A DESIGN CHANGE WHERE THE UNPURIFIED CELL CULTURE MEDIUM DILUTING THE BULK RAW MATERIAL WILL SWITCH FROM AN RPMI-BASED SOLUTION TO AN E-RDF 5-BASED SOLUTION.
P990064|S052|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/17/2013|||OK30|NEW SINGLE PASS FLOW MACHINE USED TO ESTIMATE THE EFFECTIVE ORIFICE AREA OF THE BIOPROSTHETIC HEART VALVES.
P980043|S044|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II  BIOPROSTHETIC HEART  VALVE|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/17/2013|||OK30|NEW SINGLE PASS FLOW MACHINE USED TO ESTIMATE THE EFFECTIVE ORIFICE AREA OF THE BIOPROSTHETIC HEART VALVES.
P970031|S044|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/17/2013|||OK30|NEW SINGLE PASS FLOW MACHINE USED TO ESTIMATE THE EFFECTIVE ORIFICE AREA OF THE BIOPROSTHETIC HEART VALVES.
P890003|S286|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|CHANGE TO THE CURRENT BATTERY BURN-IN TEST SYSTEM PROCESSING, INSPECTION METHODS, AND ASSOCIATED SOFTWARE.
P980035|S346|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADPATA, VERA SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|CHANGE TO THE CURRENT BATTERY BURN-IN TEST SYSTEM PROCESSING, INSPECTION METHODS, AND ASSOCIATED SOFTWARE.
P010015|S220|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P; SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/17/2013|||OK30|ALTERNATE SUPPLIER FOR MOLDED SILICONE DESICCANT COMPONENTS.
P890003|S287|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P920015|S118|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P930039|S093|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P950024|S051|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/10/2013|||OK30|IMPLEMENTATION OF AN AUTOMATIC VISUAL INSPECTION SYSTEM FOR LABELS RECEIVED AT INCOMING INSPECTION.
P100047|S030|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2013|10/17/2013|||OK30|OUTSOURCE THE MANUFACTURE OF THE SEWING RING COMPONENT OF THE DEVICE.
P900056|S127|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P920047|S061|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P070004|S006|SIENTRA, INC|6769 HOLLISTER AVENUE|SUITE 201|SANTA BARBARA|CA|93117||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SIENTRA SILICONE GEL BREAST IMPLANTS|FTR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/19/2013|12/18/2013|||APPR|APPROVAL FOR ADDITIONAL IMPLANT STYLES THAT INCORPORATE CHANGES TO THE APPROVED PMA DEVICES AND INCLUDES THE FOLLOWING STYLES: 10610-LP; 10621-MP/HP; 10712-MP; 10722-HP; 20710-LP; 10710-LP; 20721-MP/HP; 10721-MP/HP; FIVE ADDITIONAL SIZES OF THE 10512-MP STYLE IMPLANT; FOUR ADDITIONAL SIZES OF THE 10521-HP STYLE IMPLANT; FOUR ADDITIONAL SIZES OF THE 20610-LP STYLE IMPLANT; AND EIGHT ADDITIONAL SIZES OF THE 20621-MP/HP STYLE IMPLANT.
P960016|S043|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|03/12/2014|||APPR|APPROVAL TO SEMI-AUTOMATE THE PROCESS TO DECORE THE MANDREL FROM THE CATHETER SHAFT SUBASSEMBLY.
P100022|S009|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/16/2013|||OK30|MODIFY THE HANDLE ASSEMBLY AND PUSHER CANNULA/HOLDING BUSHING BONDING PROCESSES FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENTS.
P100001|S006|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/17/2013|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR STREPTAVIDIN COATED (SAC) WELLS INCLUDED IN THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR.
P090028|S007|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/17/2013|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR STREPTAVIDIN COATED (SAC) WELLS INCLUDED IN THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR.
P030026|S028|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/17/2013|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR STREPTAVIDIN COATED (SAC) WELLS INCLUDED IN THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR.
P980003|S042|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P020009|S110|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P020025|S047|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P040016|S116|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P060006|S049|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P100023|S078|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P110010|S061|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P110035|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2013|10/18/2013|||OK30|CHANGE TO IMPLEMENT THE CENTRAL MONITORING SYSTEM (CMS) AT THE STERILIZATION FACILITY.
P930031|S048|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P940019|S041|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT (LLIAC) ENDOPROSTHESIS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P980033|S037|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P110035|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P050019|S018|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P120005|S012|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|MANUFACTURING PROCESS CHANGE TO STANDARDIZE THE VISUAL INSPECTION OF G4 PLATINUM SENSOR/APPLICATOR PACKAGING PRIOR TO STERILIZATION.
P090003|S028|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P020009|S111|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P010014|S046|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/17/2013|||OK30|CHANGE TO USE A DIFFERENT MOLD RELEASE AGENT IN THE MANUFACTURING OF THE BEARING COMPONENTS OF BIOMET'S OXFORD PARTIAL KNEE SYSTEM.
P040016|S117|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P060006|S050|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONRAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P100023|S079|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P110010|S062|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P900056|S128|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P950020|S065|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|CORONARY FLEXTOME CUTTING BALLON|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2013|10/18/2013|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P060037|S027|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS FLEX MOBILE AND LPS MOBILE BEARING KNEE|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|05/13/2014|||APPR|APPROVAL FOR NEW TESTING EQUIPMENT.
P840001|S250|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS PROGRAMMING SYSTEMS, N VISION PROGRAMMER|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/23/2013|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER FOR A CRITICAL DEVICE COMPONENT.
P970004|S161|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY ACCESSORIES, EXTENSION, LEADS URINRY NEUROSTIMULATOR IMPLANTABLE INTERSTRIM FAMILY, URINARY SCREENING TRIAL|EZW|GU|30-Day Notice||N|09/23/2013|10/22/2013|||OK30|INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS.
P020025|S048|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER IIXP/BLAZER PRIME XP ABLATION CATHETERS AND EPT-1000 XP CARDIAC ABLATION CONTROLLER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/23/2013|||OK30|CHANGE IN THE QUALITY CONTROL (QC) INSPECTIONS OF THE CARDIAC ABLATION SYSTEM CABLES.
P830055|S138|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|01/22/2014|||APPR|APPROVAL FOR CHANGES TO DEVICE IDENTIFIERS AND PART IDENTIFICATION VERIFICATION PROCESSES.
P860004|S196|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|DRUG DELIVERY PROGRAMMING SYSTEMS, N VISION PROGRAMMER|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/23/2013|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER FOR A CRITICAL DEVICE COMPONENT.
P960009|S181|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS PROGRAMMING SYSTEMS, N VISION PROGRAMMER, ACCESS THERAPY CONTROLLER, ACCESS REVIEW THERPY CONTROLLER|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/23/2013|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER FOR A CRITICAL DEVICE COMPONENT.
P970004|S160|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY PROGRAMMING SYSTEMS, N VISION PROGRAMMER|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/23/2013|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER FOR A CRITICAL DEVICE COMPONENT.
P080025|S056|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL PROGRAMMING SYSTEMS, N VISION PROGRAMMER|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/23/2013|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER FOR A CRITICAL DEVICE COMPONENT.
P840001|S251|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS ACCESSORIES|LGW|NE|30-Day Notice||N|09/23/2013|10/22/2013|||OK30|INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS.
P080025|S057|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL ACCESSIRUES, EXTENSION , LEADS NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY, SCREENING TRIALING SYSTEMS|EZW|GU|30-Day Notice||N|09/23/2013|10/22/2013|||OK30|INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS.
P860004|S197|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|DRUG DELIVERY CATHETERS, DRUG DELIVERY INFUSION PUMP SYNCHROMED FAMILY, DRUG DELIVERY KITS FOR REVISIONS|LKK|HO|30-Day Notice||N|09/23/2013|10/22/2013|||OK30|INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS.
P960009|S182|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS ACCESSORIES; EXTENSION ;NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY; KINETRA FAMILY, DBS SCREEING SYSTEM|MHY|NE|30-Day Notice||N|09/23/2013|10/22/2013|||OK30|INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS.
P920047|S062|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II/ BLAZER PRIME HTD ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/23/2013|||OK30|CHANGE IN THE QUALITY CONTROL (QC) INSPECTIONS OF THE CARDIAC ABLATION SYSTEM CABLES.
P040037|S056|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/16/2013|||OK30|CLARIFICATION TO AN INSPECTION ACCEPTANCE CRITERION FOR THE ASSEMBLED PROSTHESIS AND DELIVERY SYSTEM.
P980003|S043|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/23/2013|||OK30|CHANGE IN THE QUALITY CONTROL (QC) INSPECTIONS OF THE CARDIAC ABLATION SYSTEM CABLES.
P040037|S057|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2013|10/17/2013|||OK30|ADDITION OF NEW MANUFACTURING EQUIPMENT WHICH WILL AUTOMATE THE REMOVAL OF THE VIABAHN DEVICE GRAFT COMPONENT FROM THE PROCESSING MANDREL.
P040003|S013|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000/2100|NRZ|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|09/23/2013|12/16/2013|||APPR|APPROVAL FOR A MINOR SOFTWARE CHANGE OF THE EXABLATE SYSTEM TO ADDRESS THE MICRO-SWITCH ERROR.
P110039|S004|InSightec|5 NAHUM HETH STREET||TIRAT-CARMEL||39120||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000/2100|NRZ|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/23/2013|12/17/2013|||APPR|APPROVAL FOR A MINOR SOFTWARE CHANGE OF THE EXABLATE SYSTEM TO ADDRESS THE MICRO-SWITCH ERROR.
P100028|S004|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|STENT, RENAL|FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|09/20/2013|10/08/2014|||APPR|APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS.
P080025|S058|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTER STIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/10/2013|||OK30|USE OF SAP ENTERPRISE CENTRAL COMPONENT 6 ENHANCEMENT PACK 5 AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, AND PUERTO RICO.
P010015|S221|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/23/2013|||OK30|USE OF A NEW ENTERPRISE SYSTEM FOR VARIOUS BUSINESS PROCESSES.
P010031|S403|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,CONCERTO II CRT-D, CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice||N|09/24/2013|10/23/2013|||OK30|USE OF A NEW ENTERPRISE SYSTEM FOR VARIOUS BUSINESS PROCESSES.
P090013|S115|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/23/2013|||OK30|USE OF A NEW ENTERPRISE SYSTEM FOR VARIOUS BUSINESS PROCESSES.
P980016|S442|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECT XT ICD,SECURA ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/23/2013|||OK30|USE OF A NEW ENTERPRISE SYSTEM FOR VARIOUS BUSINESS PROCESSES.
P980035|S347|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG, ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/23/2013|||OK30|USE OF A NEW ENTERPRISE SYSTEM FOR VARIOUS BUSINESS PROCESSES.
P840001|S252|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL, RESTORE, SYNERGY,|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/10/2013|||OK30|USE OF SAP ENTERPRISE CENTRAL COMPONENT 6 ENHANCEMENT PACK 5 AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, AND PUERTO RICO.
P860004|S198|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CATHETERS, SYNCHROMED, KITS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/10/2013|||OK30|USE OF SAP ENTERPRISE CENTRAL COMPONENT 6 ENHANCEMENT PACK 5 AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, AND PUERTO RICO.
P960009|S183|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA, KINETRA, SOLETRA|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/10/2013|||OK30|USE OF SAP ENTERPRISE CENTRAL COMPONENT 6 ENHANCEMENT PACK 5 AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, AND PUERTO RICO.
P970004|S162|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTER STIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/10/2013|||OK30|USE OF SAP ENTERPRISE CENTRAL COMPONENT 6 ENHANCEMENT PACK 5 AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY, JUNCOS, AND PUERTO RICO.
P110029|S013|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/18/2013|||OK30|CHANGE TO ADD ALTERNATE SUPPLIERS FOR THE INCOMING POSITIVE HUMAN PLASMA.
P050051|S022|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB LN 1L82|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2013|10/18/2013|||OK30|CHANGE TO ADD ALTERNATE SUPPLIERS FOR THE INCOMING POSITIVE HUMAN PLASMA.
P910077|S138|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Pacemaker/icd/crt non-implanted components|LATTITUDE CONSULT SYSTEM|OSR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2013|03/20/2014|||APPR|APPROVAL FOR THE LATITUDE CONSULT SYSTEM WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.
P030022|S026|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2013|10/25/2013|||OK30|CHANGE TO ADD A NEW ROTARY GRIT BLASTER.
P060019|S025|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|COOL POINT(TM) TUBING SET|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2013|05/19/2014|||APPR|APPROVAL FOR A DESIGN CHANGE IN THE TUBING SET MATERIAL AND PACKAGE SIZE FOR THE COOL POINT TUBING SET.
P050037|S041|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2013|10/24/2013|||OK30|PROPOSED CHANGES TO BIOBURDEN TESTING.
P050052|S044|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2013|10/24/2013|||OK30|PROPOSED CHANGES TO BIOBURDEN TESTING.
P040047|S028|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2013|10/24/2013|||OK30|CHANGE TO THE BIOBURDEN TESTING.
P940015|S029|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC AND SYNVISC ONE|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2013|08/06/2014|||APPR|APPROVAL FOR CHANGES TO THE QUALITY CONTROL TEST METHODS.
P040043|S057|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2013|10/25/2013|||OK30|MODIFY THE SURFACE TREATMENT OF THE NITINOL STENT COMPONENT.
P030032|S016|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|PREVELLE SILK|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2013|08/06/2014|||APPR|APPROVAL FOR CHANGES TO THE QUALITY CONTROL TEST METHODS.
P100041|S041|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|03/28/2014|||APPR|APPROVAL FOR THREE CHANGES PERTAINING TO THE CUTTING, TOLERANCES, AND MEASUREMENT OF THE CLOTH SKIRT ON THE EDWARDS SAPIEN¿ THV.
P110021|S028|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|03/28/2014|||APPR|APPROVAL FOR THREE CHANGES PERTAINING TO THE CUTTING, TOLERANCES, AND MEASUREMENT OF THE CLOTH SKIRT ON THE EDWARDS SAPIEN THV.
P980041|S026|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2013|10/17/2013|||APPR|APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.
P970038|S025|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2013|10/17/2013|||APPR|APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.
P850048|S036|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2013|10/17/2013|||APPR|APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.
P090026|S009|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2013|10/17/2013|||APPR|APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.
P030036|S063|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/25/2013|||OK30|MINOR CHANGES TO THE PLASMA TREATMENT PROCESS FOR A SILICONE TUBING COMPONENT USED IN THE MODEL 3830 SELECTSECURE LEAD.
P980035|S348|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG,RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/25/2013|||OK30|SUPPLIER SITE LOCATION TRANSFER AND PROCESS CHANGES FOR AN ACCELEROMETER CRYSTAL USED IN MODELS ADD01, ADDR01, ADDR03, ADDR06, ADDRL1,  ADDRS1, ADSR01, ADSR03, ADSR06, ADVDD01, SED01, SEDR01, SEDRL1, SES01, SESR01, AND VEDR01 AND RELIA IPG MODELS RED01, REDR01, RES01, RESR01, AND REVDD01.
P110013|S026|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/24/2013|||OK30|CHANGES TO THE VISION ASSIST PRECISION WELDER INCLUDING THE ADDITION OF A NEW MOTOR, REPLACEMENT OF THE CHUCK/COLLET FIXTURE, REMOVAL OF THE SCAN BY THE OVERHEAD CAMERA, AND UPDATED SOFTWARE TO ENSURE APPROPRIATE SET-UP IS COMPLETED.
P030009|S068|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY RX CORONARY STENT SYSTEM,INTEGRITY OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/24/2013|||OK30|CHANGES TO THE VISION ASSIST PRECISION WELDER INCLUDING THE ADDITION OF A NEW MOTOR, REPLACEMENT OF THE CHUCK/COLLET FIXTURE, REMOVAL OF THE SCAN BY THE OVERHEAD CAMERA, AND UPDATED SOFTWARE TO ENSURE APPROPRIATE SET-UP IS COMPLETED.
P060033|S081|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/24/2013|||OK30|ADDITION OF OPTICAL SENSORS TO THE GLASS SCALE OF THE FLOW METER AT THE SPECIFICATION LIMITS TO ASSIST THE OPERATOR IN ACCEPTING/ REJECTING THE HYPOTUBE UNDER INSPECTION.
P830055|S139|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2013|10/29/2013|||APPR|APPROVAL FOR CHANGES TO THE LABELING (SURGICAL TECHNIQUE) THAT ADD OR STRENGTHEN AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE. ADDITIONAL INSTRUCTIONS ON THE USE OF THE ATTUNE KNEE SYSTEM BALANCED SIZER ARE BEING ADDED TO THE EXISTING SURGICAL TECHNIQUE BASED ON CLINICAL EXPERIENCE GAINED BY SURGEONS.
P040024|S071|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/25/2013|||OK30|IN-HOUSE PREPARED ACIDIC AND BASIC SOLUTIONS, AS WELL AS IN-HOUSE PREPARED WATER FOR INJECTION.
P970051|S112|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|INTRODUCTION CP900 SERIES RECHARGEABLE BATTERIES (A29 AND A30)|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/26/2013|12/20/2013|||APPR|APPROVAL FOR INTRODUCTION OF THE RECHARGEABLE BATTERIES (A29 ANDA30) INTENDED FOR USE WITH THE CP900 SERIES OF SOUND PROCESSOR (CP910 AND CP920).
P870078|S023|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT, MODEL 105|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2013|10/24/2013|||OK30|ADDITION OF A GLUTARALDEHYDE SUPPLIER AND THE ADDITION OF TWO NEW PORCINE TISSUE SUPPLIERS.
P050019|S019|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2013|10/23/2013|||OK30|ADDITION OF AN ALTERNATE VENDOR FOR THE TACKIFIER RESIN USED IN THE PRODUCT PACKAGING ADHESIVE.
P040047|S029|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2013|10/24/2013|||OK30|CHANGE IN THE STERILIZATION RACKS.
P990052|S023|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE SYSTEM|MPV|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/27/2013|12/19/2013|||APPR|APPROVAL FOR A VORP SIZER KIT. THIS INCLUDES A MINOR MODIFICATION (MATERIAL CHANGE) TO THE VORP TEMPLATE AND THE ADDITION OF THE FLOATING MASS TRANSDUCER (FMT) SIZER FOR OPTIONAL USE DURING VIBRANT SOUNDBRIDGE IMPLANTATION SURGERY.
P110035|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2013|10/24/2013|||OK30|IMPLEMENTATION OF A PROCESS CHANGE FOR STRETCHING AND NECKING A PTFE TUBE USED IN THE MANUFACTURE OF THE DELIVERY SYSTEM.
P110013|S027|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/23/2013|||OK30|MODIFICATION OF THE STRESS TEST FOR THE OVER-THE-WIRE (OTW) LUER CONDUCTED BY THE SUPPLIER.
P030009|S069|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/23/2013|||OK30|MODIFICATION OF THE STRESS TEST FOR THE OVER-THE-WIRE (OTW) LUER CONDUCTED BY THE SUPPLIER.
P060033|S082|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2013|10/23/2013|||OK30|MODIFICATION OF THE STRESS TEST FOR THE OVER-THE-WIRE (OTW) LUER CONDUCTED BY THE SUPPLIER.
P010031|S404|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2013|06/20/2014|||APPR|APPROVAL FOR GROMMET AND MEDICAL ADHESIVE REWORK PROCESSES.
P980016|S443|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2013|06/20/2014|||APPR|APPROVAL FOR GROMMET AND MEDICAL ADHESIVE REWORK PROCESSES.
P060040|S030|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2013|03/28/2014|||APPR|APPROVAL FOR THE ADDITION OF A MOBILE POWER UNIT (MPU) FOR THE HEARTMATE II® LVAS SYSTEM.
P950005|S047|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS FLTR CATHETER UNIDIRECTIONAL, CELSIUS FLTR CATHETER BIDIRECTIONAL|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2013|01/22/2014|||APPR|APPROVAL FOR MANUFACTURING AND DESIGN CHANGES TO THE CATHETER TIP.
P010068|S036|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS FLTR CATHER UNIDIRECTIONAL,CELSIUS FLTR CATHETER BIDIRECTIONAL|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/01/2013|01/22/2014|||APPR|APPROVAL FOR MANUFACTURING AND DESIGN CHANGES TO THE CATHETER TIP.
P840001|S253|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY, SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/30/2013|||OK30|IMPLEMENTATION OF A NEW HEADER SUBASSEMBLY LASER WELD STATION.
P860004|S199|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/30/2013|||OK30|IMPLEMENTATION OF A NEW HEADER SUBASSEMBLY LASER WELD STATION.
P960009|S184|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/30/2013|||OK30|IMPLEMENTATION OF A NEW HEADER SUBASSEMBLY LASER WELD STATION.
P970004|S163|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/30/2013|||OK30|IMPLEMENTATION OF A NEW HEADER SUBASSEMBLY LASER WELD STATION.
P040038|S030|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/28/2013|||OK30|CHANGE TO THE SAMPLING PLAN USED FOR PYROGEN TESTING AT THE TEMECULA, CALIFORNIA, MANUFACTURING FACILITY.
P070015|S114|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/28/2013|||OK30|CHANGE TO THE SAMPLING PLAN USED FOR PYROGEN TESTING AT THE TEMECULA, CALIFORNIA, MANUFACTURING FACILITY.
P100021|S029|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/25/2013|||OK30|CHANGE THE SAMPLING FOR THE LIMULUS AMEBOCYTE LYSATE (LAL) BACTERIAL ENDOTOXIN TESTING.
P060037|S028|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEES|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|05/22/2014|||APPR|APPROVAL FOR ADDITION OF A NEW MANUFACTURING AREA WITH NEW EQUIPMENT.
P020047|S055|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/28/2013|||OK30|CHANGE TO THE SAMPLING PLAN USED FOR PYROGEN TESTING AT THE TEMECULA, CALIFORNIA, MANUFACTURING FACILITY.
P080025|S059|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/30/2013|||OK30|IMPLEMENTATION OF A NEW HEADER SUBASSEMBLY LASER WELD STATION.
P110019|S054|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRINCE LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/28/2013|||OK30|CHANGE TO THE SAMPLING PLAN USED FOR PYROGEN TESTING AT THE TEMECULA, CALIFORNIA, MANUFACTURING FACILITY.
P970018|S027|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2013|10/16/2013|||APPR|APPROVAL FOR LABELING CHANGES TO THE BD PREPSTAIN¿ SYSTEM.
P120005|S013|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2013|02/26/2014|||APPR|APPROVAL FOR END OF LIFE COMPONENT CHANGES (SPEAKER DRIVER-CODEC, FLASH, MOSFET, SDRAM, CAPACITOR (CAP), AND RF CHIP) IN THE RECEIVER PRINTED CIRCUIT BOARD ASSEMBLY, USE OF A HIGHER CAPACITY CAPACITOR AND IMPROVEMENT IN THE METHOD OF ATTACHMENT OF A USB PORT CONNECTOR IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
P960040|S306|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DYNAGEN EL & MINI ICD'S; INOGEN EL & MINI ICD'S; ORIGEN EL & MINI ICD'S; TELIGEN ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2013|04/11/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2)  MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.
P010012|S341|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|DYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2013|04/11/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2)  MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.
P860004|S200|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II DRUG INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/28/2013|||OK30|SYNCHROMED II BATTERY BURN-IN PROCESS BE UPDATED.
P010015|S222|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD|NKE|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P030036|S064|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P060039|S051|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P080006|S058|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P830061|S098|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P850089|S101|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP Z LEAD|NVY|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P890003|S288|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P920015|S119|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P930039|S094|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P950024|S052|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P980050|S085|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice||N|09/30/2013|10/17/2013|||OK30|UPDATE TO THE MANUFACTURING AND INSPECTION PROCESS FOR TUBING USED IN MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P090003|S029|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2013|09/04/2014|||APPR|APPROVAL FOR A CHANGE TO THE RESIN MATERIAL USED IN THE CATHETER TIP.
P100047|S031|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/30/2013|||OK30|MODIFICATION OF THE IN-PROCESS VISUAL INSPECTION AND ADDITION OF A VARIABLE INSPECTION METHOD FOR TWO DEVICE COMPONENTS WHICH ARE PART OF THE HEARTWARE® VENTRICULAR ASSIST SYSTEM.
P920015|S120|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO ELECTRODE RING SUPPLIER MATERIAL STOCK CHANGE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2013|10/29/2013|||OK30|CHANGES TO THE STOCK MATERIAL OF THE ELECTRODE RING COMPONENTS.
P100044|S012|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|INTERSECT ENT PROPEL MINI SINUS IMPLANT|OWO|EN|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|09/30/2013|01/31/2014|||APPR|APPROVAL TO REVISE THE RELEASE RATE SPECIFICATION.
P980022|S138|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL TIME PUMP & PARADIGM REAL TIME REVEL INSULIN PUMP|MDS|CH|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/03/2013|10/31/2013|||APPR|APPROVAL OF LABELING CHANGES TO THE USER GUIDE FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, AND MMT-722K), AND FOR THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEMS.
P020014|S040|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE|HHS|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/03/2013|10/30/2013|||APPR|APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BOOKLET TO INCLUDE ADDITIONAL INFORMATION ON RISKS OF CHRONIC PELVIC PAIN AND DEVICE MIGRATION.
P950015|S012|NOVADAQ CORP.|13155 DELF PLACE|UNIT 250|RICHMOND BRITISH COLUMBIA||V6V 2||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|HEART LASER CO2 TMR SYSTEM|MNO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2013|07/23/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHOX, IN BUFFALO, NEW YORK.
P020056|S023|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/08/2013|08/03/2015|||APPR|APPROVAL FOR THE REDESIGN OF THE POST APPROVAL STUDY PROTOCOL.
P100010|S032|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM, ARCTIC FRONT ADVANCE CARDUAC CRYIABKATUIB CATHETER, CRYOCONSOLE AND ACCESSORIE|OAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/16/2013|12/18/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980040|S046|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/2013|04/28/2014|||APPR|APPROVAL FOR A CHANGE IN THE PACKAGING/DELIVERY SYSTEM FOR THE TECNIS®MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODEL ZMB00. THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS IN THE NEW PACKAGING/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADEDDELIVERY SYSTEM, MODEL PMB00, AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENSHAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THE INTRAOCULAR LENS IS INTENDED TO BE PLACED IN THECAPSULAR BAG.
P980035|S349|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|11/14/2013|||OK30|ADDITION OF A SECOND LASER WELDER TO THE BATTERY MANUFACTURING LINE OF THE DEVICES.
P090013|S116|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|11/14/2013|||OK30|ADDITION OF A SECOND LASER WELDER TO THE BATTERY MANUFACTURING LINE OF THE DEVICES.
P010015|S223|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|11/14/2013|||OK30|USE OF AN ADDITIONAL LEAK TEST STATION AT THE BATTERY SUPPLIER.
P090013|S117|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|11/14/2013|||OK30|USE OF AN ADDITIONAL LEAK TEST STATION AT THE BATTERY SUPPLIER.
P100041|S042|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|11/26/2013|||OK30|IMPLEMENTATION OF AN AUTOMATED TUBE CUTTING FIXTURE TO REPLACE MANUAL CUTTING.
P110021|S029|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARD SAPIEN TRANSCATHETER HEART VALVE AND ACCESSIRUES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|11/26/2013|||OK30|IMPLEMENTATION OF AN AUTOMATED TUBE CUTTING FIXTURE TO REPLACE MANUAL CUTTING.
P960022|S010|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB SOFTLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|12/11/2013|||OK30|CHANGE OF UV CURING LIGHT BULB.
P980049|S088|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750, PARADYM DR8750|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|10/29/2013|||OK30|ADDITION OF ALTERNATIVE LASER WELDING EQUIPMENT AND A MODIFICATION TO THE LASER WELD PROGRAM.
P060027|S056|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|10/29/2013|||OK30|ADDITION OF ALTERNATIVE LASER WELDING EQUIPMENT AND A MODIFICATION TO THE LASER WELD PROGRAM.
P010013|S051|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE MODEL 10 RADIOFREQUENCY CONTROL UNIT|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/2013|04/22/2014|||APPR|APPROVAL FOR A CHANGE TO THE NOVASURE RADIOFREQUENCY CONTROLLER (RFC) TO INCORPORATE A SOFTWARE-BASED GRAPHICAL USER INTERFACE (GUI), RESULTING IN THE MODEL 10 RFC.
P980035|S350|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG,ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|11/14/2013|||OK30|USE OF AN ADDITIONAL LEAK TEST STATION AT THE BATTERY SUPPLIER.
P040037|S058|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|11/24/2013|||OK30|MODIFICATION OF THE PROCESS SETTINGS OF A BONDING PROCESS.
P050037|S042|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2013|03/07/2014|||APPR|APPROVAL FOR THE QUALIFICATION OF AN AUTOCLAVE.
P050052|S045|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice||N|10/17/2013|03/07/2014|||APPR|APPROVAL FOR THE QUALIFICATION OF AN AUTOCLAVE.
P970058|S026|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER CAD|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/17/2013|02/10/2014|||APPR|APPROVAL OF IMAGECHECKER CAD 10.0 FOR USE WITH C-VIEW IMAGES SYNTHESIZED BY THE HOLOGIC SELENIA DIMENSIONS SYSTEM.
P910077|S139|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Pacemaker/icd/crt non-implanted components|MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)|OSR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2013|04/11/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2)  MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.
P050042|S026|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV ASSAY, LN IL79|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2013|11/15/2013|||OK30|CHANGE TO A TEST METHOD FOR EVALUATION OF INCOMING AND RECALCIFIED ANTI-HCV NEGATIVE HUMAN PLASMA.
P110019|S055|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/18/2013|01/14/2014|||APPR|APPROVAL FOR A LABELING CHANGE FOR THE XIENCE XPEDITION , XIENCE XPEDITION SV, AND THE XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM FOR THE OTW PLATFORM. THIS LABELING CHANGE REQUESTED A SHELF LIFE EXTENSION FROM 12 TO 24 MONTHS.
P970020|S078|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ZETA RX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2013|11/14/2013|||OK30|ADDITION OF AN ALTERNATESUPPLIER FOR THE ADAPTION CUP COMPONENTS USED TO MANUFACTURE THE  DEVICES.
P020047|S056|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|VISION RX, MINI VISION RX,MULTILINK 8 CORONARY STENT SYSTEM(CSS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2013|11/14/2013|||OK30|ADDITION OF AN ALTERNATESUPPLIER FOR THE ADAPTION CUP COMPONENTS USED TO MANUFACTURE THE  DEVICES.
P070015|S115|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) AND XIENCE NANO EECSS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2013|11/14/2013|||OK30|ADDITION OF AN ALTERNATESUPPLIER FOR THE ADAPTION CUP COMPONENTS USED TO MANUFACTURE THE  DEVICES.
P110019|S056|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EECSS(XIENCE PRIME AND XIENCE PRIME LONG LENGTHS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2013|11/14/2013|||OK30|ADDITION OF AN ALTERNATESUPPLIER FOR THE ADAPTION CUP COMPONENTS USED TO MANUFACTURE THE  DEVICES.
P950005|S048|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|BIOSENSE WEBSTER CELSIUS FLTR CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2013|11/26/2013|||OK30|CHANGE TO THE OVEN PARAMETERS IN THE TIP REFLOW PROCESS AND IMPLEMENTATIONOF A NEW INSPECTION.
P010068|S037|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS FLTR CATHETERS|OAD|CV|30-Day Notice||N|10/18/2013|11/26/2013|||OK30|CHANGE TO THE OVEN PARAMETERS IN THE TIP REFLOW PROCESS AND IMPLEMENTATIONOF A NEW INSPECTION.
P040024|S072|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE SILK SPHAL|LMH|SU|Panel Track|Change Design/Components/Specifications/Material|N|10/21/2013|06/13/2014|14M-0872|06/30/2014|APPR|APPROVAL FOR RESTYLANE SILK. THIS DEVICE IS INDICATED FOR SUBMUCOSAL IMPLANTATION FOR LIP AUGMENTATION AND DERMAL IMPLANTATION FOR CORRECTION OF PERIORAL RHYTIDS IN PATIENTS OVER THE AGE OF 21.
P980035|S351|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2013|11/19/2013|||OK30|MODIFICATION IN A LASER SEAM WELDER.
P080026|S010|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REAL TIME HBV CONTROL KIT|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2013|11/19/2013|||OK30|MANUFACTURING PROCESS CHANGES AND QC IN-PROCESS METHOD CHANGES TO SYNTHESIZE OLIGONUCLEOTIDES ON A LARGER SCALE.
P100017|S008|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REAL TIME HBV CALIBRATOR KIT|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2013|11/19/2013|||OK30|MANUFACTURING PROCESS CHANGES AND QC IN-PROCESS METHOD CHANGES TO SYNTHESIZE OLIGONUCLEOTIDES ON A LARGER SCALE.
P110032|S006|LOMBARD MEDICAL TECHNOLOGIES INC|15420 LAGUNA CANYON ROAD|SUITE 260|IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/2013|11/21/2013|||APPR|APPROVAL FOR REVISED INSTRUCTIONS FOR USE (IFU) TO ADD WARNINGS AND PRECAUTIONS BASED ON DATA FROM ONGOING FOLLOW-UP OF SUBJECTS IN THE IDE STUDY.
P020004|S088|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2013|11/25/2013|||OK30|THE USE OF ALTERNATE POLYTETRAFLUOROETHYLENE (PTFE) RESIN RAW MATERIAL.
P100041|S043|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/2013|11/18/2013|||APPR|APPROVAL FOR MODIFYING INSPECTION OF THE Y-CONNECTOR TO GUIDEWIRE SHAFT AND ASSOCIATED CHANGES TO THE MANUFACTURING PROCEDURE DOCUMENTATION.
P110021|S030|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/2013|11/18/2013|||APPR|APPROVAL FOR MODIFYING INSPECTION OF THE Y-CONNECTOR TO GUIDEWIRE SHAFT AND ASSOCIATED CHANGES TO THE MANUFACTURING PROCEDURE DOCUMENTATION.
P000006|S034|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/2013|05/05/2014|||APPR|APPROVAL FOR AN ADDITIONAL RAW MATERIAL SUPPLIER FOR THE POLYURETHANE SPANDEX MATERIAL USED IN THE FABRICATION OF BIOFLEX® DISPERSION (USED TO MANUFACTURE TITAN RESERVOIRS AND CYLINDERS).
P980035|S352|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2013|11/21/2013|||OK30|MODIFICATION TO THE LASER RIBBON BONDING PROCESSING PARAMETERS.
P840001|S254|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2013|11/20/2013|||OK30|CHANGES TO THE MANUFACTURING TEST METHODOLOGY (FINAL FUNCTIONAL TEST) FOR HYBRIDS THAT ARE USED TO BUILD IMPLANTABLENEUROSTIMULATORS.
P970051|S113|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2013|03/05/2014|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF A MANUFACTURING PART.
P040043|S059|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2013|11/25/2013|||OK30|THE USE OF ALTERNATE POLYTETRAFLUOROETHYLENE (PTFE) RESIN RAW MATERIAL.
P040037|S059|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2013|11/25/2013|||OK30|THE USE OF ALTERNATE POLYTETRAFLUOROETHYLENE (PTFE) RESIN RAW MATERIAL.
P050006|S037|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2013|11/25/2013|||OK30|THE USE OF ALTERNATE POLYTETRAFLUOROETHYLENE (PTFE) RESIN RAW MATERIAL.
P950008|S011|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000 RETINAL TAMPONADE|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2013|11/22/2013|||OK30|ALTERNATE REAGENT SUPPLIER.
P050044|S025|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL RT3 SURGICAL HEMOSTAT|LMF|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/2013|11/15/2013|||APPR|APPROVAL FOR A DEVICE NAME CHANGE FOR THE VITAGEL RT SURGICAL HEMOSTAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT3 SURGICAL HEMOSTAT WITH NO CHANGE IN THE INDICATIONS FOR USE.
P120006|S007|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/23/2013|12/13/2013|||APPR|APPROVAL FOR MODIFICATIONS TO THE STOPCOCK VALUE, WHICH IS BEING REPLACED BY THE CALIFORNIA VALVE, AND THE NEW SUPPLIER FOR THE VALVE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM AND IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES;2) NON-ANEURYSMAL PROXIMAL AORTIC NECK:A) WITH A LENGTH OF AT LEAST 7 MM PROXIMAL TO THE ANEURYSM;B) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM; AND C) WITH AN AORTIC ANGLE OF <= 60 DEGREES IF PROXIMAL NECK IS >= 10 MM AND <= 45 DEGREES IF PROXIMAL NECK IS < 10 MM; AND3) ADEQUATE DISTAL ILIAC LANDING ZONE:A) WITH A LENGTH OF AT LEAST 10 MM; ANDB) WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 20 MM.
P110042|S018|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2013|11/21/2013|||OK30|IMPLEMENT AN AUTOMATED HIGH POWER HYBRID (HPH) RESISTANCE SCREENING SYSTEM AND CORRESPONDING 100% INSPECTION PROCESS.
P010015|S224|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P ; SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|ADDITIONAL WORKSTATIONS USED AT THE MEDIUM RATE BATTERY SUPPLIER.
P090013|S118|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|ADDITIONAL WORKSTATIONS USED AT THE MEDIUM RATE BATTERY SUPPLIER.
P980035|S353|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG; ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|ADDITIONAL WORKSTATIONS USED AT THE MEDIUM RATE BATTERY SUPPLIER.
P980035|S354|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPGS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P010015|S225|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P010031|S406|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P060039|S052|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P030036|S065|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P080006|S059|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P090013|S119|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD,REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P820003|S125|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VARIOUS MODELS OF PASYS, SPECTRAX, SYMBIOS, SYNERGYST|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P830061|S099|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P850089|S102|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P890003|S289|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P110019|S057|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/20/2013|||OK30|ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF DRUG MATERIALS AT THE CLONMEL, IRELAND FACILITY AND A CONTRACT LABORATORY.
P900061|S123|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P920015|S121|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P930039|S095|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,TORQUE CLIP DEVICE - ACCESSORY FOR 5076 LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P950024|S053|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P100041|S044|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|06/11/2014|||APPR|APPROVAL TO AUTOMATE LABEL PRINTING, IMPLEMENT NEW PEEL STRENGTH EQUIPMENT, AND RELOCATE MANUFACTURING RADIO-FREQUENCY IDENTIFICATION TAGS.
P110021|S031|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|06/11/2014|||APPR|APPROVAL TO AUTOMATE LABEL PRINTING, IMPLEMENT NEW PEEL STRENGTH EQUIPMENT, AND RELOCATE MANUFACTURING RADIO-FREQUENCY IDENTIFICATION TAGS.
P890003|S290|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD-2 LEAD|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2013|01/22/2014|||APPR|APPROVAL FOR USE OF NEW SILICONE INSULATION TUBING MATERIALS.
P980016|S445|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P980050|S086|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/19/2013|||OK30|REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
P070015|S116|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2013|11/20/2013|||OK30|ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF DRUG MATERIALS AT THE CLONMEL, IRELAND FACILITY AND A CONTRACT LABORATORY.
P920015|S122|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SPRINT QUATTRO LEADS, SPRINT FIDELIS|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/24/2013|01/22/2014|||APPR|APPROVAL FOR USE OF NEW SILICONE INSULATION TUBING MATERIALS.
P840001|S255|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 4 IMPLANTABLE NEUROSTIMULATOR,ITREL 4 IMPLANTABLE NEUROSTIMULATOR,ITREL 3 IMPLANTABLE NEUROSTIMULATOR,RESTOREPRIME|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2013|11/22/2013|||OK30|ADDITION OF A NEW EPOXY MIXER COMPONENT FOR THE MTA EPOXY DISPENSER
P960009|S185|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC IMPLANTABLE NEUROSTIMULATOR, ACTIVA SC IMPLANTABLE NEUROSTIMULATOR, ACTIVA SC IMPLANTABLE NEUROSTIMULATOR,|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2013|11/22/2013|||OK30|ADDITION OF A NEW EPOXY MIXER COMPONENT FOR THE MTA EPOXY DISPENSER
P970004|S164|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR,INTERSTIM  II IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2013|11/22/2013|||OK30|ADDITION OF A NEW EPOXY MIXER COMPONENT FOR THE MTA EPOXY DISPENSER
P080025|S060|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR,INTERSTIM II IMPLANTABLE NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2013|11/22/2013|||OK30|ADDITION OF A NEW EPOXY MIXER COMPONENT FOR THE MTA EPOXY DISPENSER
P000058|S054|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2013|12/06/2013|||APPR|APPROVAL FOR EXTENSION OF THE RHBMP-2 DRUG SUBSTANCE EXPIRATION DATE FROM 60 TO 72 MONTHS USING THE APPROVED EXPIRATION DATE MODIFICATION PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICES AND IS INDICATED FOR THE FOLLOWING:  SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, FUNCTION DEFICIT AND/OR NEUROLOGICAL DEFICIT AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. INFUSE® BONE GRAFT/LT-CAGE DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR A LAPAROSCOPIC APPROACH. PATIENTS RECEIVING THE INFUSE® BONE GRAFT/ LT-CAGE® LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE® BONE GRAFT/LT-CAGE® DEVICE.
P000054|S040|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2013|12/06/2013|||APPR|APPROVAL FOR EXTENSION OF THE RHBMP-2 DRUG SUBSTANCE EXPIRATION DATE FROM 60 TO 72 MONTHS USING THE APPROVED EXPIRATION DATE MODIFICATION PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE®BONE GRAFT AND IS INDICATED FOR THE FOLLOWING: TREATING ACUTE, OPEN TIBIAL SHAFT FRACTURES THAT HAVE BEEN STABILIZED WITH IM NAIL FIXATION AFTER APPROPRIATE WOUND MANAGEMENT. INFUSE BONE GRAFT MUST BE APPLIED WITHIN 14 DAYS AFTER THE INITIAL FRACTURE. PROSPECTIVE PATIENTS SHOULD BE SKELETALLY MATURE.
P050053|S031|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/25/2013|12/06/2013|||APPR|APPROVAL FOR EXTENSION OF THE RHBMP-2 DRUG SUBSTANCE EXPIRATION DATE FROM 60 TO 72 MONTHS USING THE APPROVED EXPIRATION DATE MODIFICATION PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE BONE GRAFT AND IS INDICATED FOR THE FOLLOWING:  AN ALTERNATIVE TO AUTOGENOUS BONE GRAFT FOR SINUS AUGMENTATIONS, AND FOR LOCALIZED ALVEOLAR RIDGE AUGMENTATIONS FOR DEFECTS ASSOCIATED WITH EXTRACTION SOCKETS.
P870078|S024|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/25/2013|11/14/2013|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE RUBBER GASKET FOR THE JAR USED TO PACKAGE THE DEVICE.
P790007|S040|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT|LWR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/25/2013|11/14/2013|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE RUBBER GASKET FOR THE JAR USED TO PACKAGE THE DEVICE.
P100020|S012|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TESTS|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/05/2013|12/16/2013|||APPR|APPROVAL FOR A CHANGE TO THE SOFTWARE OF THE COBAS Z480 AMPLIFICATION/ DETECTION ANALYZER, WHICH IS A COMPONENT OF THE COBAS 4800 SYSTEM.
P970003|S166|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2013|05/09/2014|||APPR|APPROVAL FOR LABELING THAT DESCRIBES THE CONDITIONS UNDER WHICH MAGNETIC RESONANCE IMAGING (MRI) CAN BE USED WHEN RESIDUAL VNS LEADS OR LEAD FRAGMENTS (ABANDONED LEADS) REMAIN IN THE BODY.
P060008|S107|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/25/2013|01/21/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P990081|S023|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/15/2013|||OK30|AUTOMATION OF TESTING PROCESSES (CURRENTLY PERFORMED SEMI-MANUALLY) USING THE NEW AUTOMATED DISPENSER VERIFICATION MODULE (DVM).
P100027|S012|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/15/2013|||OK30|AUTOMATION OF TESTING PROCESSES (CURRENTLY PERFORMED SEMI-MANUALLY) USING THE NEW AUTOMATED DISPENSER VERIFICATION MODULE (DVM).
P020055|S011|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/15/2013|||OK30|AUTOMATION OF TESTING PROCESSES (CURRENTLY PERFORMED SEMI-MANUALLY) USING THE NEW AUTOMATED DISPENSER VERIFICATION MODULE (DVM).
P910023|S322|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|FORTIFY VR/DR ICD'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|CHANGE TO A TOOL USED DURING DEVICE MANUFACTURING.
P030054|S253|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY AND UNIFY QUADRA CRT-D'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|CHANGE TO A TOOL USED DURING DEVICE MANUFACTURING.
P060038|S018|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/22/2013|||OK30|CHANGE THE SUPPLIER TO PERFORM ANALYSIS ON RECEIVING MATERIALS FROM AN EXTERNAL CONTRACT LABORATORY TO IN-HOUSE.
P890057|S021|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)|LSZ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/22/2013|||OK30|CHANGE TO ADD A SUPPLIER FOR THE STOPCOCK.
P050042|S027|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P050051|S023|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P080023|S023|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P060035|S021|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P110029|S014|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P980007|S031|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P910007|S040|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P120008|S004|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2013|11/26/2013|||OK30|REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
P860057|S114|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2013|11/26/2013|||OK30|ADDITION OF A NEW CLEAN ROOM AND TWO ADDITIONAL PIECES OF ASSOCIATEDEQUIPMENT AT AN EXISTING MANUFACTURING FACILITY.
P030017|S181|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SYSTEM|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/29/2013|02/16/2014|||APPR|APPROVAL FOR HEAD-ONLY MAGNETIC RESONANCE CONDITIONAL (I.E., MR CONDITIONAL) LABELING FOR THE PRECISION SPECTRA SPINAL CORD STIMULATION (SCS) SYSTEM.
N970003|S157|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|FORMIO,VITALIO,ADVANTIO,INGENIO,ALTRUA,INSIGNIA PACEMAKERS|LWP|CV|30-Day Notice||N|10/29/2013|11/26/2013|||OK30|ADD INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.
P960040|S307|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA,TELIGEN,ENERGEN,INCEPTA,VITALITY ICDS|LWP|CV|30-Day Notice||N|10/29/2013|11/26/2013|||OK30|ADD INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.
P030005|S104|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE,INTUA CRT-PS|NKE|CV|30-Day Notice||N|10/29/2013|11/26/2013|||OK30|ADD INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.
P010012|S342|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS,ENERGEN,INCEPTA,PUNCTUA CRT-DS|LWP|CV|30-Day Notice||N|10/29/2013|11/26/2013|||OK30|ADD INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.
P030045|S002|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, ILIAC|INTRASTENT DOUBLESTRUT STENT|NIO|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/30/2013|04/16/2015|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE INTRASTENT DOUBLESTRUT STENT SYSTEM.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISI-PRO BALLOON-EXPANDABLE PERIPHERAL STENT SYSTEM AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITHA REFERENCE VESSEL DIAMETER OF 5 TO 10 MM.
P110029|S015|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUAL/CONF|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD FOR INCOMING LOTS OF TRITON X-100.
P050051|S024|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD FOR INCOMING LOTS OF TRITON X-100.
P010015|S226|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD , LEAD VENTRICULAR PACING LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P060035|S022|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD FOR INCOMING LOTS OF TRITON X-100.
P030036|S066|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|LEAD ANCHORING SLEEVE KIT; SELECT SECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P080023|S024|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD FOR INCOMING LOTS OF TRITON X-100.
P060039|S053|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P080006|S060|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P090013|S120|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSURE FIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P050042|S028|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD FOR INCOMING LOTS OF TRITON X-100.
P830061|S100|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P980007|S032|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD FOR INCOMING LOTS OF TRITON X-100.
P110037|S012|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADJUSTMENT TO THE PH RANGE FOR THE LYSIS REAGENT.
P910007|S041|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD FOR INCOMING LOTS OF TRITON X-100.
P120008|S005|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|ADDITION OF A QUALITY CONTROL TEST METHOD FOR INCOMING LOTS OF TRITON X-100.
P110042|S019|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|INSOURCING OF THE Q-GUIDE ELECTRODE INSERTION TOOL.
P900061|S124|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACH HEADER, END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P920015|S123|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CIONNECTIR PORT PIN PLUG, LEAD ADAPTOR, SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P930039|S096|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P950024|S054|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P980050|S087|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P970018|S028|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/31/2013|04/28/2014|||APPR|APPROVAL FOR THE BD PREPMATE¿ AUTOMATED ACCESSORY WITH THE UPGRADED CONTROL ELECTRONICS TO COMPLY WITH CURRENT TECHNOLOGIES.
P850089|S103|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATION IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P890003|S291|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD, SERVICE KIT PACEMAKER REPAIR KIT|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2013|11/26/2013|||OK30|REDUCE THE EXPOSURE TIME DURING ETHYLENE-OXIDE HALF-CYCLE TESTING.
P060025|S013|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|MEDTRONIC 3F AORTIC BIOPROSTHESIS MODEL 1000|LWR|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2013|07/30/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC IN SANTA ANA, CALIFORNIA.
P950029|S085|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2013|11/26/2013|||OK30|ALTERNATE EQUIPMENT FOR POLYMERIZATION, PLASMA CLEANING, AND WIRE BONDING.
P980049|S089|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR 8750,  PARADYM RF VR/RF DR 9750|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2013|11/26/2013|||OK30|ALTERNATE EQUIPMENT FOR POLYMERIZATION, PLASMA CLEANING, AND WIRE BONDING.
P060027|S057|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750, PARADYM RF CRT-D 9750|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2013|11/26/2013|||OK30|ALTERNATE EQUIPMENT FOR POLYMERIZATION, PLASMA CLEANING, AND WIRE BONDING.
P050037|S043|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice||N|10/31/2013|11/27/2013|||OK30|ELIMINATION OF A TEST PERFORMED ON THE RADIESSE DERMAL FILLER.
P050052|S046|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice||N|10/31/2013|11/27/2013|||OK30|ELIMINATION OF A TEST PERFORMED ON THE RADIESSE DERMAL FILLER.
P040047|S030|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2013|11/21/2013|||OK30|ELIMINATION OF A REDUNDANT DRYING TEST.
P110035|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2013|11/24/2013|||OK30|CHANGE TO THE DATA COLLECTION METHOD AND FREQUENCY IN THE EXTRUSION MANUFACTURING PROCESS.
P020025|S049|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|MAESTRO 3000 CARDIAC ABLATION SYSTEM|OAD|CV|Special (Immediate Track)||N|10/31/2013|12/05/2013|||APPR|APPROVAL FOR MINOR LABELING CHANGES, INCLUDING UPDATES IN ACCORDANCE WITH IEC 60601-1 THIRD EDITION.
P920047|S063|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|MAESTRO 3000 CARDIAC ABLATION SYSTEM|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/2013|12/05/2013|||APPR|APPROVAL FOR MINOR LABELING CHANGES, INCLUDING UPDATES IN ACCORDANCE WITH IEC 60601-1 THIRD EDITION.
P980003|S045|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|MAESTRO 3000 CARDIAC ABLATION SYSTEM|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/2013|12/05/2013|||APPR|APPROVAL FOR MINOR LABELING CHANGES, INCLUDING UPDATES IN ACCORDANCE WITH IEC 60601-1 THIRD EDITION.
P840001|S256|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|VARIOUS FAMILIES OF SPINAL CORD STIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2013|11/27/2013|||OK30|MOVE THE MANUFACTURING OF THE GUIDEWIRE FROM ONE BUILDING TO ANOTHER BUILDING ON THE SAME CAMPUS.
P810006|S048|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAR INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2013|03/18/2014|||APPR|APPROVAL FOR ADDING INCREASED SYSTEM CAPACITY FOR WATER PURIFICATION OF THE CURRENT REVERSE OSMOSIS/ELECTRO-DEIONIZATION WATER PURIFICATION SYSTEM (ROEDI).
P850010|S046|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT HELITENSE ABSORBABLE COLLLAGENHEMOSTATIC AGENT MICROFIBRILLAR FORM|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2013|03/18/2014|||APPR|APPROVAL FOR ADDING INCREASED SYSTEM CAPACITY FOR WATER PURIFICATION OF THE CURRENT REVERSE OSMOSIS/ELECTRO-DEIONIZATION WATER PURIFICATION SYSTEM (ROEDI).
P900033|S032|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|135 Review Track For 30-Day Notice||N|11/01/2013|03/18/2014|||APPR|APPROVAL FOR ADDING INCREASED SYSTEM CAPACITY FOR WATER PURIFICATION OF THE CURRENT REVERSE OSMOSIS/ELECTRO-DEIONIZATION WATER PURIFICATION SYSTEM (ROEDI).
P110040|S001|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2013|11/24/2013|||OK30|MODIFICATION OF THE BONDING PROCESS FOR THE STABILITY MEMBER SUBCOMPONENT OF THEDELIVERY SYSTEM.
P110029|S016|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2013|11/26/2013|||OK30|CHANGE IN AN INCOMING QUALITY CONTROL METHOD FOR ANTI-HBS NEGATIVE PLASMAS.
P840062|S035|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLA TAPE, COLLA PLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2013|03/18/2014|||APPR|APPROVAL FOR ADDING INCREASED SYSTEM CAPACITY FOR WATER PURIFICATION OF THE CURRENT REVERSE OSMOSIS/ELECTRO-DEIONIZATION WATER PURIFICATION SYSTEM (ROEDI).
P110013|S028|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/04/2013|01/30/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) TO INCLUDE UPDATED CLINICAL INFORMATION.
P020025|S050|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLA TIP MIFI XP ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2013|12/03/2013|||OK30|CHANGE IN THE QUALITY CONTROL (QC) INSPECTIONS OF THE CARDIAC ABLATION SYSTEM CABLES.
P100040|S013|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2013|01/07/2014|||APPR|APPROVAL FOR A PRODUCT LINE EXTENSION CONSISTING OF THE ADDITION OF 11 VALIANT FREEFLO TAPERED STENT GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM AND IS INDICATED FOR THE ENDOVASCULAR REPAIR OF ISOLATED LESIONS (EXCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: ILIAC OR FEMORAL ARTERY ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; NONANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18 TO 42 MM (FUSIFORM AND SACCULAR ANEURYSMS/PENETRATING ULCERS) OR 18 MM TO 44 MM (BLUNT TRAUMATIC AORTIC INJURIES); AND NONANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS ¿ 20 MM.
P930031|S049|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2013|12/04/2013|||OK30|CHANGE TO THE INNER MEMBER COMPONENT MANUFACTURING EQUIPMENT.
P100014|S011|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/04/2013|02/26/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980033|S038|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2013|12/04/2013|||OK30|CHANGE TO THE INNER MEMBER COMPONENT MANUFACTURING EQUIPMENT.
P100044|S013|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL MINI SINUS IMPLANT|OWO|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2013|01/09/2014|||APPR|APPROVAL FOR A DESIGN MODIFICATION TO THE DELIVERY SYSTEM ACCESSORYCOMPONENT OF THE PREVIOUSLY APPROVED PROPEL MINI SINUS IMPLANT.
P120006|S008|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRI VASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM; TRI VASCULAR, INC OVATION PRIME ABDOMINAL ABDOMINAL STENT GRAFT|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/2013|12/02/2013|||APPR|APPROVAL FOR CHANGES TO INSTRUCTIONS FOR USE THAT ADD AND STRENGTHEN CAUTION STATEMENTS.
P950037|S129|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|12/03/2013|||OK30|ADD TWO SECOND TIER COMPONENT SUPPLIERS.
P050023|S070|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILIES OF ICD'S|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|12/03/2013|||OK30|ADD TWO SECOND TIER COMPONENT SUPPLIERS.
P030052|S013|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|URO VYSION BLADDER CANCER KIT|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|11/27/2013|||OK30|CHANGING THE CONFIGURATION OF THEIR CURRENT LABEL PRINTER, LABEL PRINTING SOFTWARE,AND LABEL INSPECTION SYSTEM FOR THE FOLLOWING FISH ASSAYS: VYSIS ALK BREAK APART FISH PROBE KIT, UROVYSION BLADDER CANCER KIT, AND PATHVYSION HER-2DNA PROBE KIT.
P980024|S011|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|THE PATH VYSION HER-2 DNA PRODE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|11/27/2013|||OK30|CHANGING THE CONFIGURATION OF THEIR CURRENT LABEL PRINTER, LABEL PRINTING SOFTWARE,AND LABEL INSPECTION SYSTEM FOR THE FOLLOWING FISH ASSAYS: VYSIS ALK BREAK APART FISH PROBE KIT, UROVYSION BLADDER CANCER KIT, AND PATHVYSION HER-2DNA PROBE KIT.
P080032|S014|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|12/02/2013|||OK30|CHANGE TO THE MANUFACTURING OF A CABLE CONNECTOR, THE ADDITION OF ANINSPECTION STEP AND THE ELIMINATION OF A FINAL ACCEPTANCE ACTIVITY.
P030035|S114|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM & ANTHEM RF CRT-P'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|12/04/2013|||OK30|ALTERNATE BURN-IN (BI) FOR THE ENVIRONMENTAL SCREENING DURING THE MANUFACTURE OF PACEMAKER AND CRT-P HYBRID ASSEMBLIES.
P950037|S130|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|12/03/2013|||OK30|TWO NEW WELDING STATIONS, COPYING EXISTING PROCESSES FROM ONE WORKSTATION TO ANOTHER AND MINOR PROCESS PARAMETER CHANGES.
P110012|S005|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT|OWE|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|11/27/2013|||OK30|CHANGING THE CONFIGURATION OF THEIR CURRENT LABEL PRINTER, LABEL PRINTING SOFTWARE,AND LABEL INSPECTION SYSTEM FOR THE FOLLOWING FISH ASSAYS: VYSIS ALK BREAK APART FISH PROBE KIT, UROVYSION BLADDER CANCER KIT, AND PATHVYSION HER-2DNA PROBE KIT.
P050023|S071|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILIES OF ICD'S & CRT-D'S|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|12/03/2013|||OK30|TWO NEW WELDING STATIONS, COPYING EXISTING PROCESSES FROM ONE WORKSTATION TO ANOTHER AND MINOR PROCESS PARAMETER CHANGES.
P070008|S048|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV AND LV-T CRT-P'S|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|12/03/2013|||OK30|TWO NEW WELDING STATIONS, COPYING EXISTING PROCESSES FROM ONE WORKSTATION TO ANOTHER AND MINOR PROCESS PARAMETER CHANGES.
P880086|S236|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT DR, ACCENT DR RF, ACCENT SR, ACCENT SR RF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2013|12/04/2013|||OK30|ALTERNATE BURN-IN (BI) FOR THE ENVIRONMENTAL SCREENING DURING THE MANUFACTURE OF PACEMAKER AND CRT-P HYBRID ASSEMBLIES.
P980022|S140|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF SENSOR|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2013|10/02/2015|||APPR|APPROVAL FOR ADDING DUPLICATE EXISTING MANUFACTURING STEPS TO THE PREPARATION OF BULK GLUCOSE OXIDASE (GOX) PERFORMED BY THE SUPPLIER FOR USE IN THE SPONSOR¿S ENLITE SENSOR (MODEL: MMT-7008) AND SOF-SENSOR (MODELS: MMT-7002 AND MMT-7003) DEVICES.  THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM. THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REALTIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO RECORDER AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P840062|S036|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE AND COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2013|10/31/2014|||APPR|APPROVAL FOR A CHANGE IN CLEANING VALIDATION PROCESS FOR MANUFACTURING EQUIPMENT.
P850010|S047|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2013|10/31/2014|||APPR|APPROVAL FOR A CHANGE IN CLEANING VALIDATION PROCESS FOR MANUFACTURING EQUIPMENT.
P810006|S049|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2013|10/31/2014|||APPR|APPROVAL FOR A CHANGE IN CLEANING VALIDATION PROCESS FOR MANUFACTURING EQUIPMENT.
P980022|S142|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR|MDS|CH|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/07/2013|12/06/2013|||APPR|APPROVAL OF PRODUCT SPECIFICATION REQUIREMENTS FOR THE GLUCOSE OXIDASE MATERIAL USED IN THE SOF-SENSORS (MODELS: MMT-7002 AND MMT-7003) AND THE ENLITE SENSOR (MODEL: MMT-7008).
P120010|S002|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|11/07/2013|12/06/2013|||APPR|APPROVAL OF PRODUCT SPECIFICATION REQUIREMENTS FOR THE GLUCOSE OXIDASE MATERIAL USED IN THE SOF-SENSORS (MODELS: MMT-7002 AND MMT-7003) AND THE ENLITE SENSOR (MODEL: MMT-7008).
P120010|S001|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2013|10/02/2015|||APPR|APPROVAL FOR ADDING DUPLICATE EXISTING MANUFACTURING STEPS TO THE PREPARATION OF BULK GLUCOSE OXIDASE (GOX) PERFORMED BY THE SUPPLIER FOR USE IN THE SPONSOR¿S ENLITE SENSOR (MODEL: MMT-7008) AND SOF-SENSOR (MODELS: MMT-7002 AND MMT-7003) DEVICES.  THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM. THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REALTIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO RECORDER AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P110033|S001|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2013|12/06/2013|||OK30|PROPOSED ADDITION OF NEW STERILIZATION EQUIPMENT FOR USE IN JUVEDERM VOLUMA XC STERILIZATION.
P110042|S020|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/06/2013|01/31/2014|||APPR|APPROVAL FOR A NEW BATTERY SUPPLIER FOR THE SQ-RX MODEL 1010 IMPLANTABLE PULSE GENERATOR.
P110042|S021|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S- ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2013|12/03/2013|||OK30|ADD A SECOND SUPPLIER FACILITY FOR PERFORMING LASER WELDING AND WETBLAST PROCESSES.
P950037|S131|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CYLOS, PHILOS/PHILOS II, EVIA, ENTOVIA, ECURO, EFFECTA, & ESTELLA FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2013|06/20/2014|||APPR|APPROVAL FOR PSW 1306.U PROGRAMMER SOFTWARE.
P050023|S072|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX FAMILIES OF ICD'S & CRT-D'S, ILESTO & IFORNIA FAMILIES OF ICD'S & CRT-D'S|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2013|06/20/2014|||APPR|APPROVAL FOR PSW 1306.U PROGRAMMER SOFTWARE.
P000009|S056|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|LUMOS FAMILY OF ICD'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2013|06/20/2014|||APPR|APPROVAL FOR PSW 1306.U PROGRAMMER SOFTWARE.
P070008|S049|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS, EVIA, & ENTOVIS FAMILIES OF CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2013|06/20/2014|||APPR|APPROVAL FOR PSW 1306.U PROGRAMMER SOFTWARE.
P980022|S143|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK REAL-TIME SYSTEM,IPRO RECORDER CGMS SYSTEM,IPRO2 RECORDER CGM SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2013|09/25/2014|||APPR|APPROVAL FOR A CHANGE TO THE SUPPLIER AND MATERIAL OF THE BATTERY ANODE FOR THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), THE IPRO2 RECORDER (MODEL: MMT-7741) AND THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), WHICHARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO2 PROFESSIONAL CGM AND MINIMED 530G SYSTEMS.
P120010|S003|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINILINK REAL-TIME TRANSMITTER|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2013|09/25/2014|||APPR|APPROVAL FOR A CHANGE TO THE SUPPLIER AND MATERIAL OF THE BATTERY ANODE FOR THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), THE IPRO2 RECORDER (MODEL: MMT-7741) AND THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), WHICHARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO2 PROFESSIONAL CGM AND MINIMED 530G SYSTEMS.
P030017|S182|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2013|12/04/2013|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE SPINAL CORD STIMULATOR SYSTEM.
P110043|S004|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLON-EXPANDABEL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|12/20/2013|||OK30|CHANGE TO THE VISUAL INSPECTION PROCESS FOR THE OMNILINK ELITE STENT.
P120010|S005|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|08/21/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A PNEUMATIC PRESS TOOL IN PLACEOF A MANUAL PRESS TOOL IN THE MANUFACTURING PROCESS OF THE PARADIGM REAL-TIME INSULIN PUMP(MODELS:MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVELINSULIN-PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), GUARDIAN REALTIMEMONITOR (MODELS: CSS7100 AND CSS17100K) AND THE MINIMED 530G INSULIN PUMP(MODELS: MMT-551 AND MMT-751). THESE PARTS ARE COMPONENTS OF THE PARADIGM REAL-TIMESYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CONTINUOUS GLUCOSEMONITORING SYSTEMS AND THE MINIMED 530G SYSTEM RESPECTIVELY.
P100047|S032|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/06/2013|03/26/2014|||APPR|APPROVAL FOR A CHANGE OF THE THREAD LOCKING ADHESIVE USED ON THERETENTION NUT WHICH SECURES THE CONNECTOR TO THE CONTROLLER HOUSING.
P960004|S064|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROX|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|12/04/2013|||OK30|REMOVAL OF TWO REDUNDANT INSPECTIONS AT THE MANUFACTURING SITE FOR FINELINE II LEADS.
P940015|S030|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|12/05/2013|||OK30|USE OF ALTERNATE EQUIPMENT FOR FILLING SYRINGES.
P980022|S145|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|12/06/2013|||OK30|IN-PROCESS STORAGE CHANGE TO A NITROGEN CABINET DURING MANUFACTURING OF THE SOF-SENSOR (MODELS: MMT-7002 C, D, E).
P980022|S146|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|11/23/2015|||APPR|APPROVAL FOR CHANGES IN THE WELDING PROCESS OF THE CLEAR PLASTIC WINDOW TO THE PUMP CASE OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K) AND THE MINIMED 530G INSULIN PUMP (MODEL: MMT-551). THE PARADIGM REAL-TIME INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME SYSTEM; THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME REVEL SYSTEM; AND THE MINIMED 530G INSULIN PUMP IS A PART OF THE MINIMED 530G SYSTEM.
P120010|S004|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|11/23/2015|||APPR|APPROVAL FOR CHANGES IN THE WELDING PROCESS OF THE CLEAR PLASTIC WINDOW TO THE PUMP CASE OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K) AND THE MINIMED 530G INSULIN PUMP (MODEL: MMT-551). THE PARADIGM REAL-TIME INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME SYSTEM; THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME REVEL SYSTEM; AND THE MINIMED 530G INSULIN PUMP IS A PART OF THE MINIMED 530G SYSTEM.
P980022|S147|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|08/21/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A PNEUMATIC PRESS TOOL IN PLACEOF A MANUAL PRESS TOOL IN THE MANUFACTURING PROCESS OF THE PARADIGM REAL-TIME INSULIN PUMP(MODELS:MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVELINSULIN-PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), GUARDIAN REALTIMEMONITOR (MODELS: CSS7100 AND CSS17100K) AND THE MINIMED 530G INSULIN PUMP(MODELS: MMT-551 AND MMT-751). THESE PARTS ARE COMPONENTS OF THE PARADIGM REAL-TIMESYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CONTINUOUS GLUCOSEMONITORING SYSTEMS AND THE MINIMED 530G SYSTEM RESPECTIVELY.
P980022|S148|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|12/05/2013|||OK30|PC-BASED MANUFACTURING SOFTWARE UPDATE FROM VERSION 2.2A TO VERSION 2.3A AT THE MEDTRONIC MINIMED, NORTHRIDGE FACILITY, AND UPDATE FROM VERSION 2.0D TO VERSION 2.3A AT THE MPROC, JUNCOS FACILITY FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K, MMT-722, AND MMT-722K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, AND MMT-723K), THE GUARDIAN REAL-TIME MONITOR (MODEL: CSS7100) AND THE MINIMED 530G INSULIN PUMP (MODELS MMT-551 AND MMT-751).
P120010|S006|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|12/05/2013|||OK30|PC-BASED MANUFACTURING SOFTWARE UPDATE FROM VERSION 2.2A TO VERSION 2.3A AT THE MEDTRONIC MINIMED, NORTHRIDGE FACILITY, AND UPDATE FROM VERSION 2.0D TO VERSION 2.3A AT THE MPROC, JUNCOS FACILITY FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K, MMT-722, AND MMT-722K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, AND MMT-723K), THE GUARDIAN REAL-TIME MONITOR (MODEL: CSS7100) AND THE MINIMED 530G INSULIN PUMP (MODELS MMT-551 AND MMT-751).
P080014|S020|HOLOGIC, INC.|250 CAMPUS DRIVE||MARLBOROUGH|MA|01750||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV HR|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|12/03/2013|||OK30|INCREASE OF THE MANUFACTURING LOT SIZE FOR THE CLEAVASE ENZYME SOLUTION USING MANUAL FILLING WITH GRAVIMETRIC CONFIRMATION.
P080015|S011|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2013|12/03/2013|||OK30|INCREASE OF THE MANUFACTURING LOT SIZE FOR THE CLEAVASE ENZYME SOLUTION USING MANUAL FILLING WITH GRAVIMETRIC CONFIRMATION.
P080026|S011|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV ASSAY|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/11/2013|||OK30|MANUFACTURING CHANGE CONVERSION FROM A MANUAL TO AN AUTOMATED KIT PACKAGING SYSTEM.
P100017|S009|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/11/2013|||OK30|MANUFACTURING CHANGE CONVERSION FROM A MANUAL TO AN AUTOMATED KIT PACKAGING SYSTEM.
P100044|S014|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL AND PROPEL MINI SINUS IMPLANTS|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/06/2013|||OK30|ADD AN ALTERNATE MATERIAL SUPPLIER.
P030022|S027|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|09/05/2014|||APPR|APPROVAL FOR THE ADDITION OF A VAPOR DEGREASER AND MACHINING EQUIPMENT.
P990081|S024|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/16/2013|||OK30|ADDITION OF A NEW SUPPLIER FOR A PCBA USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.
P100027|S013|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/16/2013|||OK30|ADDITION OF A NEW SUPPLIER FOR A PCBA USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.
P020055|S012|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7.) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/16/2013|||OK30|ADDITION OF A NEW SUPPLIER FOR A PCBA USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.
P010019|S036|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR, O2 OPTIX,  AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM,AIR OPTIX AQUA|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/05/2013|||OK30|TRANSITION FROM A SEMI-AUTOMATED TO A FULLY AUTOMATEDMANUFACTURING PROCESS.
P040002|S044|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2013|01/24/2014|||APPR|APPROVAL FOR DIMENSIONAL MODIFICATION OF THE INNER CORE OF THE AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM.
P840001|S257|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MRICS AND LZ OCTAD LEAD FAMILIES|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/12/2013|||OK30|MAKE CHANGES TO THE MRICS LEAN LINE INTEGRATION.
P120006|S009|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/12/2013|04/23/2014|||APPR|APPROVAL FOR A CHANGE TO THE INDICATION FOR USE FOR THE OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEMS BY CLARIFYING THAT PERCUTANEOUS ACCESS AND FEMORAL CUTDOWN ARE APPROPRIATE VASCULAR ACCESS TECHNIQUES. THE DEVICE, THE TRIVASCULAR OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES (FEMORAL CUTDOWN OR PERCUTANEOUS), DEVICES, AND/OR ACCESSORIES; 2) PROXIMAL AORTIC LANDING ZONE:A) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM AT 13 MM BELOW THE INFERIOR RENAL ARTERY; AND B) WITH AN AORTIC ANGLE OF =< 60 DEGREES IF PROXIMAL NECK IS => 10 MM AND =<45 DEGREES IF PROXIMAL NECK IS <10 MM; AND 3) DISTAL ILIAC LANDING ZONE: A) WITH A LENGTH OF AT LEAST 10 MM; ANDB) WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 20 MM.
P050023|S073|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 3XO/5X10|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2013|01/17/2014|||APPR|APPROVAL FOR A MODIFICATION OF THE LAND PAD GEOMETRY FOR THE HIGH VOLTAGE DIODES ON THE SUBSTRATE.
P050037|S044|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/11/2013|||OK30|PROCESS CHANGE TO IN HOUSE ENDOTOXIN TESTING.
P050052|S047|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/11/2013|||OK30|PROCESS CHANGE TO IN HOUSE ENDOTOXIN TESTING.
P050044|S026|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT (VITAGEL)|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/14/2013|02/11/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE VITAPREP PLASMA SEPARATOR COMPONENT OF VITAGEL SURGICAL HEMOSTAT: ADDITION OF HYDRAFOAM AND SILICONE O-RING INSERTS TO THE INSIDE OF THE CAP, INCREASE IN THE LENGTH OF THE PLUNGER STOPPER SUPPORT, REMOLDING OF THE CAP, AND UPDATE IN THE PRIMARY PACKAGING.
P890023|S020|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|OCUFILCON D EXTENDED WEAR LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/13/2013|||OK30|MANUFACTURING CHANGE TO ADD A NEW QUALITY TEST FOR MANUFACTURING.
P780007|S052|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|POLYMACON EXTENDED WEAR LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2013|12/13/2013|||OK30|MANUFACTURING CHANGE TO ADD A NEW QUALITY TEST FOR MANUFACTURING.
P840001|S258|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREPRIME|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/13/2013|||OK30|ADDITION OF ALTERNATE SUPPLIERS TO MANUFACTURE THE SILICONE SEAL COMPRESSION ASSEMBLIES.
P110042|S022|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/12/2013|||OK30|ADD AN ADDITIONAL GLOVEBOX TO BE USED IN MANUFACTURING OPERATIONS FOR THE S-ICD SYSTEM.
P960009|S186|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/13/2013|||OK30|ADDITION OF ALTERNATE SUPPLIERS TO MANUFACTURE THE SILICONE SEAL COMPRESSION ASSEMBLIES.
P970004|S165|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/13/2013|||OK30|ADDITION OF ALTERNATE SUPPLIERS TO MANUFACTURE THE SILICONE SEAL COMPRESSION ASSEMBLIES.
P080025|S061|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/13/2013|||OK30|ADDITION OF ALTERNATE SUPPLIERS TO MANUFACTURE THE SILICONE SEAL COMPRESSION ASSEMBLIES.
P960011|S024|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)|LZP|OP|30-Day Notice||N|11/13/2013|12/10/2013|||OK30|BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P010029|S018|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/10/2013|||OK30|BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)
P890003|S292|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK HOME MONITOR,CARDIOSIGHT READER,CARELINK NETWORK DEVICE DATA MANAGEMENT APPLICATION|NVZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/12/2013|11/22/2013|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P060034|S007|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC IGM EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/12/2013|||OK30|CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.
P060031|S007|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBC EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/12/2013|||OK30|CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.
P050048|S009|BIO-RAD LABORATORIES|6565 185TH AVE, NE||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|BIO-RAD MONOLISA ANTI-HBS EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/12/2013|||OK30|CHANGE TO ADD TEST SAMPLES AS AN ADDITIONAL ACCEPTANCE CRITERION TO THE FINAL KIT RELEASE QUALITY CONTROL TESTING PROCEDURE.
P890023|S021|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|OCUFILCON D EXTENDED-WEAR LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|01/09/2015|||APPR|APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.
P780007|S053|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|POLYMACON EXTENDED-WEAR LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|01/09/2015|||APPR|APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.
P080011|S028|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COMFILCON A EXTENDED WEAR-LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|01/09/2015|||APPR|APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.
P030011|S022|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2013|12/13/2013|||OK30|CHANGE IN THE MANUFACTURING SITE OF THE INTERNAL BATTERY OF THE COMPANION 2 DRIVER SYSTEM.
P100040|S014|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2013|12/12/2013|||OK30|CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.
P100021|S030|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2013|12/12/2013|||OK30|CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.
P110011|S005|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2013|12/12/2013|||OK30|CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.
P060033|S083|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENVEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2013|12/12/2013|||OK30|CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.
P030009|S070|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2013|12/12/2013|||OK30|CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.
P110013|S029|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2013|12/12/2013|||OK30|CONSOLIDATE AND TRANSFER EXTRUSION ACTIVITIES TO THE SANTA ROSA, CA FACILITY.
P000040|S031|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2013|12/11/2013|||OK30|REPLACEMENT OF A VISUAL AID USED IN MANUFACTURING WITH A VISION SYSTEM THAT WILL AUTOMATE ALL ASPECTS OF THE VISUAL AID AS WELL AS INSPECT FOR THE PRESENCE OF ADDITIONAL COMPONENTS.
P970018|S029|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/15/2013|12/13/2013|||OK30|REMOVAL OF AN IN-PROCESS QUALITY CONTROL (QC) TEST AND A FINAL RELEASE TEST ASSOCIATED WITH THE MANUFACTURE OF BD DENSITY REAGENT.
P110002|S003|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/18/2013|||OK30|TOOL CHANGE FOR THE MILLING OF THE INFERIOR ENDPLATE.
P110009|S003|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROTHESIS|MJO|OR|30-Day Notice||N|11/18/2013|12/18/2013|||OK30|TOOL CHANGE FOR THE MILLING OF THE INFERIOR ENDPLATE.
P100026|S001|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/18/2013|||OK30|ADDITION OF A SECONDARY COMPONENT SUPPLIER.
P030017|S183|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECUSION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/10/2013|||OK30|BOSTON SCIENTIFIC NEUROMODULATION (BSN) VALENCIA FACILITY TO ADD THE EQUIPMENT AND PROCESSES FOR MULTI-LUMEN TUBES.
P010031|S407|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D IPG|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/17/2013|||OK30|MODIFICATION TO THE BATTERY HEADER WELD POWER RANGE.
P040020|S051|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/18/2013|||OK30|MANUFACTURING CHANGE TO ADD AN ALTERNATE QUALITY TEST FOR MANUFACTURING.
P040045|S041|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/18/2013|01/16/2014|||APPR|APPROVAL FOR A CHANGE IN THE VISCOSITY SPECIFICATION FROM 120-170 CPS TO100-170 CPS FOR THE REACTIVE MONOMER MIX.
P010031|S408|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/16/2013|||OK30|A NEW LASER WELDING STATION FOR THE BATTERY ELECTRICAL CONNECTION PROCESS AS WELL AS A CHANGE IN MANUFACTURING LOCATION FOR THE LASER WELDING PROCESS AND OPEN CIRCUIT VOLTAGE INSPECTION (OCV).
P980016|S446|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/16/2013|||OK30|A NEW LASER WELDING STATION FOR THE BATTERY ELECTRICAL CONNECTION PROCESS AS WELL AS A CHANGE IN MANUFACTURING LOCATION FOR THE LASER WELDING PROCESS AND OPEN CIRCUIT VOLTAGE INSPECTION (OCV).
P010012|S343|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2,EASYTRAK 3,ACUITY SPIRAL CRTS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/06/2013|||OK30|INSOURCING OF HEAT BOND PROCESSES FOR THE SUBJECT LEFT VENTRICULAR (LV) LEADS.
P050046|S022|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE CRTS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/06/2013|||OK30|INSOURCING OF HEAT BOND PROCESSES FOR THE SUBJECT LEFT VENTRICULAR (LV) LEADS.
P110035|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VACULAR SELF EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/18/2013|||OK30|REMOVAL OF A REDUNDANT TENSILE TEST INSPECTION AND IMPLEMENTATION OF A NEW MOLD.
P030017|S184|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/13/2013|||OK30|ADDITIONAL COMPONENTS FOR A STERILIZATION PROCESS.
P010014|S047|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/18/2013|||OK30|USE OF AN ADDITIONAL MILL IN THE MANUFACTURING OF THE FEMORAL AND TIBIAL COMPONENTS OF BIOMET¿S OXFORD PARTIAL KNEE SYSTEM.
P100047|S033|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEART WARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/18/2013|02/13/2014|||APPR|APPROVAL FOR USE OF A NEW FORMULATION OF THE THERMOPLASTICVULCANIZATE (TPZ) MATERIAL USED IN THE MANUFACTURE OF THE MONITOR DATA CABLE, BATTERY PACK CABLE, DC ADAPTOR INPUT CABLE, AND ALARM SILENCE ADAPTOR COMPONENTS OF THE DEVICE.
P980035|S355|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2013|12/17/2013|||OK30|MANUFACTURE UPDATE TO THE 0.8 ÌM BICMOS (BIPOLAR COMPLEMENTARY METAL OXIDE SEMICONDUCTOR) PROCESS FLOW AT THE IC SUPPLIER.
P960040|S308|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNTUA ICD'S, TELIGEN ICD'S, ENERGEN ICD'S AND INCEPTA ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2013|12/17/2013|||OK30|MANUFACTURING CHANGES TO THE HIGH VOLTAGE CAPACITOR FOR THE DEVICES.
P010031|S410|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA C RT-D; VIVA S CRT-D; VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2013|12/17/2013|||OK30|MANUFACTURE UPDATE TO THE 0.8 ÌM BICMOS (BIPOLAR COMPLEMENTARY METAL OXIDE SEMICONDUCTOR) PROCESS FLOW AT THE IC SUPPLIER.
P980016|S448|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD; EVERA S VR ICD; EVERA XT DR ICD; EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2013|12/17/2013|||OK30|MANUFACTURE UPDATE TO THE 0.8 ÌM BICMOS (BIPOLAR COMPLEMENTARY METAL OXIDE SEMICONDUCTOR) PROCESS FLOW AT THE IC SUPPLIER.
P080027|S015|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2013|12/17/2013|||OK30|CHANGE TO UPGRADE THE ORAQUICK AUTOMATION ULTRASONIC WELDING SYSTEMS TO IMPROVE THE MANUFACTURING PROCESS.
P860004|S201|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II DUG INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2013|12/13/2013|||OK30|LOCATION OF A SUPPLIER BE CHANGED.
P010031|S409|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/12/2013|||OK30|SOFTWARE AND HARDWARE CHANGES TO THE RADIO FREQUENCY TEST EQUIPMENT.
P980016|S447|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/12/2013|||OK30|SOFTWARE AND HARDWARE CHANGES TO THE RADIO FREQUENCY TEST EQUIPMENT.
P110013|S030|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/15/2013|||OK30|CHANGE TO ALLOW RECEIVING INSPECTION ACTIVITIES TO BE COMPLETED AT MEDTRONIC MEXICO.
P030009|S071|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY RAPID EXCHANGE CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/15/2013|||OK30|CHANGE TO ALLOW RECEIVING INSPECTION ACTIVITIES TO BE COMPLETED AT MEDTRONIC MEXICO.
P060033|S084|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2013|12/15/2013|||OK30|CHANGE TO ALLOW RECEIVING INSPECTION ACTIVITIES TO BE COMPLETED AT MEDTRONIC MEXICO.
P010012|S344|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA CRT-DS, COGNIS CRT-DS, ENERGEN CRT-D'S, INCEPTA CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2013|12/17/2013|||OK30|MANUFACTURING CHANGES TO THE HIGH VOLTAGE CAPACITOR FOR THE DEVICES.
P910077|S140|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/20/2013|06/20/2014|||APPR|APPROVAL FOR THE LATITUDE NXT 2.0 SOFTWARE FOR THE WAVE COMMUNICATOR MODEL 6460, CHANGES TO THE WAVE COMMUNICATOR 6280, APPROVAL OF THE WAVE COMMUNICATOR 6290, AND UPDATES TO THE COMMUNICATION SOFTWARE FOR WAVE COMMUNICATOR MODELS 6498 AND6476.
P010031|S411|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2013|12/12/2013|||OK30|CHANGE IN MANUFACTURING AT THE SUPPLIER TO HELP CENTER THE DISTRIBUTION OF THECAPACITANCE OF THE TRIPLE STACK CAPACITOR IN ORDER TO IMPROVE YIELD.
P980016|S449|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR, EVERA S VR ICD, EVERA XT DR ICD AND EVERA VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2013|12/12/2013|||OK30|CHANGE IN MANUFACTURING AT THE SUPPLIER TO HELP CENTER THE DISTRIBUTION OF THECAPACITANCE OF THE TRIPLE STACK CAPACITOR IN ORDER TO IMPROVE YIELD.
P040047|S031|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE 1.0CC|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2013|12/18/2013|||OK30|ADDITION OF AN IN-HOUSE ENDOTOXIN TESTING OF THE COAPTITE PRODUCT.
P100033|S001|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Prostrate cancer genes nucleic acid amplification test system|PROGENSA PCA3 ASSAY|OYM|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2013|12/12/2013|||OK30|REVISED METHOD FOR VALUE ASSIGNING CONCENTRATION OF PSA CONTROL B DURING MANUFACTURING.
P110042|S023|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2013|12/16/2013|||OK30|ADDITIONAL LASER SPOT WELD SYSTEM USED IN THE MANUFACTURING PROCESS FOR THE S-ICD SYSTEM.
P980018|S018|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|Special (Immediate Track)||N|11/21/2013|11/26/2013|||APPR|APPROVAL FOR LABELING CHANGES MADE TO ENHANCE SAFETY OF HERCEPTEST.  WHEN USED FOR GASTRIC AND GASTROESOPHAGEAL CANCER INDICATIONS.
P010030|S045|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST DEVICE|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2013|12/20/2013|||OK30|ADDITIONAL SPOT WELDER AS WELL AS UPDATES TO INSPECTION INSTRUCTIONS FOR THE LIFEVEST WEARABLE CARDIOVERTER DEFIBRILLATOR.
P910023|S323|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Pulse generator, permanent, implantable|ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2013|02/26/2014|||APPR|
P900056|S129|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER|MCX|CV|30-Day Notice||N|11/21/2013|12/15/2013|||OK30|REMOVAL OF 34 OF THE 48 QUALITY INSPECTIONS WITHIN THE ROTAWIRE GUIDEWIRE MANUFACTURING PROCESS.
P850010|S048|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2013|12/16/2013|||OK30|ADDITIONAL PACKAGING MACHINE FOR THE HELISTAT (ACS) PRODUCT.
P920047|S064|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD,BLAZER PRIME HTD|LPB|CV|30-Day Notice||N|11/21/2013|12/18/2013|||OK30|VENDOR MANUFACTURING CHANGES FOR THE BLAZER II, BLAZER II HTD, BLAZER PRIME HTD, BLAZER II XP, AND BLAZER PRIME XP ABLATION CATHETERS.
P030054|S254|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY PF CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2013|02/26/2014|||APPR|APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P020025|S051|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS|OAD|CV|30-Day Notice||N|11/21/2013|12/18/2013|||OK30|VENDOR MANUFACTURING CHANGES FOR THE BLAZER II, BLAZER II HTD, BLAZER PRIME HTD, BLAZER II XP, AND BLAZER PRIME XP ABLATION CATHETERS.
P030035|S115|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2013|02/26/2014|||APPR|APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P970013|S057|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2013|02/26/2014|||APPR|APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P870072|S057|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE(VAD)|DSQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2013|12/18/2013|||APPR|APPROVAL FOR A CHANGE TO THE FINAL INSPECTION OF THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM.
P880086|S237|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2013|02/26/2014|||APPR|APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P040033|S024|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/21/2013|12/11/2015|||APPR|APPROVAL FOR AN UPDATE TO THE DEVICE LABELING TO INCLUDE THE RESULTS OF THE COMPLETED UNITED KINGDOM (UK) POST-APPROVAL STUDY.
P880006|S087|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/ REGENCY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/21/2013|02/26/2014|||APPR|APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.
P100026|S002|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2013|12/20/2013|||OK30|RE-IMPLEMENTATION OF A PREVIOUSLY USED LASER WELDER AS A BACKUP WELDER.
P860057|S115|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESES DEVICE FAMILIES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.
P010041|S046|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.
P870056|S063|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS,PORCINE VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.
P110013|S031|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORNARY STENT SYSTEM; RESOLUTE INTEGRITY OTW ZOTAROLINUS ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|CHANGES RELATED TO THE SOFTWARE USED IN THE MEASUREMENT PROCESS OF THE WAVEFORMS AT THE ¿WAVE FORMING¿ WORK STEP AND THE STENTS AT THE ¿ELECTRO-POLISH¿ WORK STEP.
P870077|S057|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING,CARPENTIER-EDWARDS DURAFLEX LOW|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.
P000007|S044|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.
P030009|S072|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY RX CORONARY STENT SYSTEM; INTEGRITY OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|CHANGES RELATED TO THE SOFTWARE USED IN THE MEASUREMENT PROCESS OF THE WAVEFORMS AT THE ¿WAVE FORMING¿ WORK STEP AND THE STENTS AT THE ¿ELECTRO-POLISH¿ WORK STEP.
P100041|S046|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.
P110021|S033|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/19/2013|||OK30|ADDITION OF TERMINAL LIQUID STERILIZATION OVENS NO. 6 AND NO. 7.
P050037|S045|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/20/2013|||OK30|CHANGE IN PACKAGING MANUFACTURER FACILITY.
P050052|S048|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/20/2013|||OK30|CHANGE IN PACKAGING MANUFACTURER FACILITY.
P030036|S067|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/16/2013|||OK30|TRANSFER OF INCOMING INSPECTION TO A NEW SITE FOR A NUMBER OF COMPONENTS USED IN THE MANUFACTURE OF MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P080006|S061|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/16/2013|||OK30|TRANSFER OF INCOMING INSPECTION TO A NEW SITE FOR A NUMBER OF COMPONENTS USED IN THE MANUFACTURE OF MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P920015|S124|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUANTTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2013|12/16/2013|||OK30|TRANSFER OF INCOMING INSPECTION TO A NEW SITE FOR A NUMBER OF COMPONENTS USED IN THE MANUFACTURE OF MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
P950037|S132|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ENTOVIS PROMRI PACEMAKER SYSTEM|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/2013|05/04/2014|||APPR|APPROVAL FOR MRI-CONDITIONAL LABELING FOR THE ENTOVIS SR / SR-T / DR / DR-T PACEMAKERS, AND THE SUPPORTING PROGRAMMER SOFTWARE VERSION PSW 1307.U. WHEN AN ENTOVIS PACEMAKER IS USED IN CONJUNCTION WITH SETROX S 53/60 OR SAFIO 53/60 PACEMAKER LEADS IT SHALL BEIDENTIFIED AS THE ENTOVIS PROMRI SYSTEM.
P030052|S014|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|12/20/2013|||OK30|CHANGE TO THE FERMENTATION STAGE OF THE UROVYSION AND PATHVYSION ASSAY MANUFACTURING PROCESSES.
P980024|S012|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|12/20/2013|||OK30|CHANGE TO THE FERMENTATION STAGE OF THE UROVYSION AND PATHVYSION ASSAY MANUFACTURING PROCESSES.
P110033|S002|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|07/30/2014|||APPR|APPROVAL FOR INCREASED DRYER CAPACITY IN JUVÉDERM VOLUMA XC MANUFACTURING.
P990009|S038|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|12/24/2013|||OK30|CHANGE TO THE MATERIAL OF A COMPONENT IN THE FLOSEAL KIT.
P040047|S032|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE 1.0CC|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|12/20/2013|||OK30|MOVEMENT OF THE MANUFACTURING PROCESS OF A CRITICAL COMPONENT TO A NEW FACILITY.
P030017|S185|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/22/2013|03/07/2014|||APPR|APPROVAL FOR THE PRECISION SPECTRA OBSERVATIONAL MECHANICAL GATEWAY (OMG) TO BE USED AS AN ADJUNCT ACCESSORY WITH THE PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM.
P930031|S050|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|12/20/2013|||OK30|ELIMINATE AN IN-PROCESS VERIFICATION ACTIVITY.
P980033|S039|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT (VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|12/20/2013|||OK30|ELIMINATE AN IN-PROCESS VERIFICATION ACTIVITY.
P050023|S074|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ILESTO ICD'S AND CRT-D'S|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/2013|05/04/2014|||APPR|APPROVAL FOR MRI-CONDITIONAL LABELING FOR THE ENTOVIS SR / SR-T / DR / DR-T PACEMAKERS, AND THE SUPPORTING PROGRAMMER SOFTWARE VERSION PSW 1307.U. WHEN AN ENTOVIS PACEMAKER IS USED IN CONJUNCTION WITH SETROX S 53/60 OR SAFIO 53/60 PACEMAKER LEADS IT SHALL BEIDENTIFIED AS THE ENTOVIS PROMRI SYSTEM.
P940019|S042|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|12/20/2013|||OK30|ELIMINATE AN IN-PROCESS VERIFICATION ACTIVITY.
P070008|S050|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|EVIA CRT-P'S|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/2013|05/04/2014|||APPR|APPROVAL FOR MRI-CONDITIONAL LABELING FOR THE ENTOVIS SR / SR-T / DR / DR-T PACEMAKERS, AND THE SUPPORTING PROGRAMMER SOFTWARE VERSION PSW 1307.U. WHEN AN ENTOVIS PACEMAKER IS USED IN CONJUNCTION WITH SETROX S 53/60 OR SAFIO 53/60 PACEMAKER LEADS IT SHALL BEIDENTIFIED AS THE ENTOVIS PROMRI SYSTEM.
P100023|S080|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|05/19/2014|||APPR|APPROVAL TO REDUCE THE KINETIC DRUG RELEASE (KDR) SAMPLE QUANTITY FOR BATCH RELEASE AND STABILITY TESTING.
P000009|S057|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|XELOS DR-T ICD'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/25/2013|05/04/2014|||APPR|APPROVAL FOR MRI-CONDITIONAL LABELING FOR THE ENTOVIS SR / SR-T / DR / DR-T PACEMAKERS, AND THE SUPPORTING PROGRAMMER SOFTWARE VERSION PSW 1307.U. WHEN AN ENTOVIS PACEMAKER IS USED IN CONJUNCTION WITH SETROX S 53/60 OR SAFIO 53/60 PACEMAKER LEADS IT SHALL BEIDENTIFIED AS THE ENTOVIS PROMRI SYSTEM.
P000029|S076|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2013|05/08/2014|||APPR|APPROVAL FOR THE INTRODUCTION OF IN-HOUSE PRODUCED WATER FOR INJECTION (WFI), AS WELL AS CLEARANCE FOR THE USE OF PHARMACEUTICAL GRADE NAOH AND HCL, RATHER THAN THE GRADE CURRENTLY USED BY THE FIRM.
P110010|S063|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|11/25/2013|12/20/2013|||OK30|CHANGES TO THE IN-PROCESS ENDOTOXIN TESTING DURING COMPONENT MANUFACTURING.
P100023|S081|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYTEM|NIQ|CV|30-Day Notice||N|11/25/2013|12/20/2013|||OK30|CHANGES TO THE IN-PROCESS ENDOTOXIN TESTING DURING COMPONENT MANUFACTURING.
P040016|S118|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|11/25/2013|12/20/2013|||OK30|CHANGES TO THE IN-PROCESS ENDOTOXIN TESTING DURING COMPONENT MANUFACTURING.
P020009|S112|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|11/25/2013|12/20/2013|||OK30|CHANGES TO THE IN-PROCESS ENDOTOXIN TESTING DURING COMPONENT MANUFACTURING.
P060006|S051|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice||N|11/25/2013|12/20/2013|||OK30|CHANGES TO THE IN-PROCESS ENDOTOXIN TESTING DURING COMPONENT MANUFACTURING.
P080006|S062|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTTAIN ABILITY|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|UPDATE TO THE VALIDATED RANGES OF THE ELUTION AND DETERMINATION OF RELATED SUBSTANCES METHODS USED IN RELEASE TESTING ATTAIN ABILITY LEADS.
P100009|S001|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MIRACLIP CLIP DELIVERY SYSTEM|NKM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/26/2013|06/13/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100023|S082|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE SYSTEMS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P950020|S066|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|CORONARY FLEXTOME CUTTING BALLOON|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P110010|S064|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P020009|S113|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P040016|S119|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P980040|S047|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||TECNIS 1-PIECE IOL TEDNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|USE OF ALTERNATIVE DEGASSING PARAMETERS.
P060006|S052|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P080010|S010|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL 3-PIECE IOL|MFK|OP|30-Day Notice||N|11/26/2013|12/18/2013|||OK30|USE OF ALTERNATIVE DEGASSING PARAMETERS.
P010030|S046|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST® WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/20/2013|||OK30|MODIFICATION TO THE SOFTWARE INSTALLATION PROCESS TO USE ONLY THE SD CARD UTILITY TO PERFORM FLASH APPLICATION LOADING.
N970012|S097|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 SERIES INFATABLE PENILE PROSTHESIS|JCW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|03/06/2014|||APPR|APPROVAL FOR CHANGES TO MANUAL INSPECTION METHODS, ADDITION OF AN ALTERNATE AUTOMATED INSPECTION METHOD AND REDEFINITION OF THE DIAMETER MEASUREMENT REGION.
P940019|S043|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT LILAC ENDOPROSTHESIS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P100009|S002|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM|NKM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/26/2013|01/28/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P930031|S051|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P980033|S040|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/18/2013|||OK30|CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
P870072|S058|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE (VAD)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|12/19/2013|||OK30|USE OF A NEW COULOMETER IN THE MANUFACTURE OF THE POLYMER MATERIAL.
P100034|S007|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOTFF-100A SYSTEM|NZK|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/12/2014|11/12/2014|||APPR|APPROVAL FOR CHANGES TO THE NOVOTTF-100A INSULATED ELECTRODE (INE) TRANSDUCER ARRAY MANUFACTURING PROCESS TO IMPROVE ITS EFFICIENCY BY AUTOMATING CERTAIN MANUAL PROCESSING STEPS.
P100014|S012|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2013|05/12/2014|||APPR|INTRODUCTION OF IN-HOUSE PRODUCED WATER FOR INJECTION (WFI).
P970029|S025|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|PEARL 8.0 HANDPIECE|MNO|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/26/2013|01/28/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970055|S013|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM|PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUD)|MYM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/23/2013|||OK30|CHANGE IN A SUPPLIER OF A COMPONENT USED IN THIS ASSAY.
P970054|S010|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY|MYL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/23/2013|||OK30|CHANGE IN A SUPPLIER OF A COMPONENT USED IN THIS ASSAY.
P890003|S293|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/12/2013|||OK30|IMPLEMENTATION OF A SOFTWARE-RELATED LEAD ASSEMBLY PROCESS IMPROVEMENT, ACCOMMODATING SERIAL NUMBER VARIABILITY.
P830061|S101|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD,VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/12/2013|||OK30|IMPLEMENTATION OF A SOFTWARE-RELATED LEAD ASSEMBLY PROCESS IMPROVEMENT, ACCOMMODATING SERIAL NUMBER VARIABILITY.
P920015|S125|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/12/2013|||OK30|IMPLEMENTATION OF A SOFTWARE-RELATED LEAD ASSEMBLY PROCESS IMPROVEMENT, ACCOMMODATING SERIAL NUMBER VARIABILITY.
P930039|S097|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/12/2013|||OK30|IMPLEMENTATION OF A SOFTWARE-RELATED LEAD ASSEMBLY PROCESS IMPROVEMENT, ACCOMMODATING SERIAL NUMBER VARIABILITY.
P950024|S055|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/12/2013|||OK30|IMPLEMENTATION OF A SOFTWARE-RELATED LEAD ASSEMBLY PROCESS IMPROVEMENT, ACCOMMODATING SERIAL NUMBER VARIABILITY.
P980050|S088|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/12/2013|||OK30|IMPLEMENTATION OF A SOFTWARE-RELATED LEAD ASSEMBLY PROCESS IMPROVEMENT, ACCOMMODATING SERIAL NUMBER VARIABILITY.
P980016|S450|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/17/2013|||OK30|ADDITIONAL EQUIPMENT FOR CAPACITOR MANUFACTURING AT MECC TO INCREASE MANUFACTURING CAPACITY FOR THE  DEVICES.
P830055|S140|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/26/2013|||OK30|CHANGE TO THE GRIT BLASTING PROCESS FOR THE MBT REVISION CEMENTED TIBIAL TRAY.
P010031|S412|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2013|12/17/2013|||OK30|ADDITIONAL EQUIPMENT FOR CAPACITOR MANUFACTURING AT MECC TO INCREASE MANUFACTURING CAPACITY FOR THE  DEVICES.
P080006|S063|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY MODEL 4X96 LEAD|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/2013|05/15/2014|||APPR|APPROVAL FOR CHANGES TO THE MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) ELUTION METHOD AND SPECIFICATIONS, TRANSFER OF THE MCRD MANUFACTURING LOCATION, USE OF A SURROGATE TIP COMPONENT FOR MCRD TESTING, AND UPDATES TO THE MCRD SHELF LIFE PROTOCOL FOR ATTAIN ABILITY LEAD MODELS 4196, 4296 AND 4396.
P960016|S044|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/2013|03/21/2014|||APPR|APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR:THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.
P040014|S021|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CATHETER (NON-IRRIGATED)|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/2013|03/21/2014|||APPR|APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR:  THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.
P040042|S026|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHETER (NON-IRRIGATED), SAFIRE TX CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/2013|03/21/2014|||APPR|APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR:THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.
P060019|S026|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH CATHETER (6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6 HOLE IRRIGATED), SAFIRE BLU SP|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/2013|03/21/2014|||APPR|APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR:THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.
P040012|S053|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2013|06/05/2014|||APPR|APPROVAL FOR A CHANGE IN THE VISUAL INSPECTION CRITERIA FOR BENT STRUTS FOR THE RX ACCULINK CAROTID STENT SYSTEM.
P110016|S010|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/27/2013|03/21/2014|||APPR|APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR:THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.
P980022|S149|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMPS|MDS|CH|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/29/2013|12/24/2013|||APPR|APPROVAL FOR A LABELING CHANGE TO THE ERRATA SHEET TO PROVIDE ADDITIONAL INFORMATION ABOUT POTENTIAL WATER DAMAGE TO THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS: MMT-522, MMT-522K, MMT-722 AND MMT-722K) AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS: MMT-523, MMT-523K, MMT-723 AND MMT-723K).
P050044|S027|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|RT3 SURGICAL HEMOSTAT|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2013|01/27/2014|||APPR|APPROVAL OF THE TRANSFER OF STERILITY TESTING OF VITAGEL RT3 FILLED SYRINGES INHOUSE.
P910023|S324|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT,CURRENT ACCEL,CURRENT +,ELLIPSE,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2013|12/17/2013|||OK30|ALTERNATE ORGANIC SUBSTRATE MANUFACTURER FOR USE IN THE HYBRID ASSEMBLIES FOR THE ICD AND CRT-D DEVICES.
P030054|S255|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, PROMOTE ACCEL,PROMOTE Q, PROMOTE QUADRA,PROMOTE+,QUADRA ASSURA,UNIFY,UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2013|12/17/2013|||OK30|ALTERNATE ORGANIC SUBSTRATE MANUFACTURER FOR USE IN THE HYBRID ASSEMBLIES FOR THE ICD AND CRT-D DEVICES.
P860057|S116|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROTHESIS,CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICA|DYE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/27/2013|01/24/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950009|S017|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCAL POINT SLIDE PROFILER|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|12/02/2013|02/26/2014|||APPR|APPROVAL FOR REPLACEMENT OF THE CURRENT SCAN CONTROLLER BOARD (SCB) UTILIZED IN THE BD FOCALPOINT¿ SLIDE PROFILER WITH DIGITAL IMAGE SYSTEM CONFIGURATION.
P070015|S117|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V, XIENCE NANO,XIENCE PRIME, XIENCE PRIME LONG LESION,XIENCE XPEDITION XIENCE XPEDITION SMALL VESSEL AND XPEDITIO|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/27/2013|09/04/2014|||APPR|APPROVAL FOR THE POST APPROVAL STUDY LABELING UPDATES FOR THE CLINICAL STUDIES FOLLOWED UNDER THIS PMA FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENTS.
P040037|S060|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/02/2013|09/19/2014|14M-1452|10/14/2014|APPR|APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THESE DEVICES ARE INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY DE NOVO AND RESTENOTIC LESIONS UP TO 270 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 7.5 MM.  THESE DEVICES ARE ALSO INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN  SUPERFICIAL FEMORAL ARTERY IN-STENT RESTENOTIC LESIONS UP TO 270 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 6.5 MM.
P050052|S049|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use in the hands|RADIESSE INJECTABLE IMPLANT|PKY|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/02/2013|06/04/2015|15M-2078|06/05/2015|APPR|APPROVAL FOR THE RADIESSE® INJECTABLE IMPLANT. THE DEVICE IS INDICATED FOR HAND AUGMENTATION TO CORRECT VOLUME LOSS IN THE DORSUM OF THE HANDS
P970003|S167|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|MODEL 201 PROGRAMMING WAND|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2013|01/02/2014|||OK30|REPLACE THE CAPACITOR USED IN THE ASSEMBLY OF THE PRINTED CIRCUIT BOARDS FOR THE PROGRAMMING WAND.
P810002|S088|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT,  STANDARD AND MASTERS  MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2013|12/19/2013|||OK30|IMPLEMENTATION OF A NEW SEALING PLATE CONFIGURATION AND A CHANGE IN SEALING PARAMETERS FOR THE TYVEK LID OF THE INNER AND OUTER TRAYS FOR MECHANICAL HEART VALVE PACKAGING AT ONE MANUFACTURING FACILITY.
P050047|S033|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2013|04/17/2014|||APPR|APPROVAL FOR A CHANGE TO THE QUALITY CONTROL TESTING METHOD USED TO CONFIRM THE CONCENTRATION OF LIDOCAINE AND LIDOCAINE DEGREDANTS IN JUVÉDERM HYALURONATE GEL IMPLANTS.
P100049|S007|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2013|12/27/2013|||OK30|CHANGES TO THE FIRMS CLEANING MACHINE, CLEANING DETERGENT, MAXIMUM BEAD LOAD AND CLEANING TEMPERATURE, AND THE ADDITION OF MESHES DURING THE CLEANING AND RINSING PROCESS.
N970012|S098|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2013|01/02/2014|||OK30|PROPOSED ADDITION OF AN ALTERNATIVE METHOD (AUTOMATED) FOR APPLYING A PLUG TO THE KINK RESISTANT TUBING DURING THE MANUFACTURING APPLICATION OF AN ANTIMICROBIAL SURFACE TREATMENT.
P000053|S049|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2013|01/02/2014|||OK30|PROPOSED ADDITION OF AN ALTERNATIVE METHOD (AUTOMATED) FOR APPLYING A PLUG TO THE KINK RESISTANT TUBING DURING THE MANUFACTURING APPLICATION OF AN ANTIMICROBIAL SURFACE TREATMENT.
P910056|S015|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ENVISTA IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2013|12/30/2013|||OK30|CHANGE IN MACHINERY USED IN THE MANUFACTURING OF THE VIAL USED TO PACKAGE THE ENVISTA INTRAOCULAR LENS.
P050012|S052|DEXCOM, INC.|5555 OBERLIN DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/06/2013|03/05/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE DEXCOM STUDIO SOFTWARE: SUPPORT WAS ADDED FOR WINDOWS 8, OPEN OFFICE, AND CANADIAN ENGLISH AND CANADIAN FRENCH INSTALLATIONS; IMPROVED SYSTEM PERFORMANCE FOR LARGE CLINICS THAT MANAGE LARGE NUMBERS OF PATIENTS; THE WORD BLINDED WAS ADDED TO EVERY CHART WHEN THE RECEIVER DATA IS DOWNLOADED IN BLINDED MODE; THE TOOLTIP WAS TRANSLATED INTO VARIOUS LANGUAGES; AND LABELING CHANGES WERE MADE TO THE DEXCOM STUDIO SOFTWARE GUIDE, G4 SENSOR MANUAL, AND RECEIVER REPLACEMENT GUIDE.
P050016|S010|CORIN U.S.A.|5670 W CYPRESS STREET|SUITE C|TAMPA|FL|33607||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|CORMET HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|12/13/2013|04/03/2014|||APPR|APPROVAL FOR AN ADDITION TO THE LABELING FOR THE CORMET HIP RESURFACING SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.
P120005|S014|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/06/2013|03/05/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE DEXCOM STUDIO SOFTWARE: SUPPORT WAS ADDED FOR WINDOWS 8, OPEN OFFICE, AND CANADIAN ENGLISH AND CANADIAN FRENCH INSTALLATIONS; IMPROVED SYSTEM PERFORMANCE FOR LARGE CLINICS THAT MANAGE LARGE NUMBERS OF PATIENTS; THE WORD BLINDED WAS ADDED TO EVERY CHART WHEN THE RECEIVER DATA IS DOWNLOADED IN BLINDED MODE; THE TOOLTIP WAS TRANSLATED INTO VARIOUS LANGUAGES; AND LABELING CHANGES WERE MADE TO THE DEXCOM STUDIO SOFTWARE GUIDE, G4 SENSOR MANUAL, AND RECEIVER REPLACEMENT GUIDE.
P950037|S133|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SELOX ST 53,SELOX ST 60,SELOX JT 45,SELOX JT 53,SETROX S 45,SETROX S53,SETROX S60,DEXTRUS 4135,DEXTRUS 4136,DETRUS 4137,|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2013|01/06/2014|||OK30|TWO ADDITIONAL INJECTION MOLDING TOOLS USED TO MANUFACTURE THE SILICONE SLEEVES OF THE PACEMAKER LEADS.
P960058|S105|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2013|01/08/2014|||OK30|USE OF A NEW STERILIZATION CYCLE.
P970021|S039|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2013|02/24/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS CORPORATION IN BUFFALO GROVE, ILLINOIS.
P110019|S058|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION,XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2013|01/07/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN  NORTH BRUNSWICK, NEW JERSEY.
P110001|S011|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|RX HERCULINK ELITE RENAL STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|12/11/2013|06/06/2014|||APPR|APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS.
P100026|S003|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/11/2013|02/07/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P930014|S070|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2013|01/09/2014|||OK30|USE OF A NEW ABERROMETER.
P800002|S020|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT- ENDOAVITENE 5 MM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2013|01/14/2014|||OK30|ADD A NEW SUPPLIER FOR THE BLISTER TRAY USED FOR THE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT-ENDO AVITENE PRODUCT.
P890055|S052|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP|LKK|HO|30-Day Notice||N|12/12/2013|01/15/2014|||OK30|NEW STEAM STERILIZER.
P070004|S007|SIENTRA, INC|6769 HOLLISTER AVENUE|SUITE 201|SANTA BARBARA|CA|93117||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SIENTRA SILICONE GEL BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2013|01/08/2014|||OK30|CHANGES TO THE MATERIAL OF THE BREAST IMPLANT MOLDS.
P980035|S356|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2013|01/08/2014|||OK30|USE OF SPACE SOFTWARE RELEASE 6.0 (BUILD 7), A STATISTICAL PROCESS CONTROL (SPC) SOFTWARE.
P830061|S102|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2013|01/08/2014|||OK30|USE OF SPACE SOFTWARE RELEASE 6.0 (BUILD 7), A STATISTICAL PROCESS CONTROL (SPC) SOFTWARE.
P090013|S121|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2013|01/08/2014|||OK30|USE OF SPACE SOFTWARE RELEASE 6.0 (BUILD 7), A STATISTICAL PROCESS CONTROL (SPC) SOFTWARE.
P930039|S098|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2013|01/08/2014|||OK30|USE OF SPACE SOFTWARE RELEASE 6.0 (BUILD 7), A STATISTICAL PROCESS CONTROL (SPC) SOFTWARE.
P050034|S012|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X  AND WIDE ANGLE 2.7X|NCJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2013|01/15/2014|||OK30|POSSIBILITY OF REWORK AND RETESTING ACTIVITIES.
P000012|S047|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2013|01/09/2014|||OK30|CHANGE TO DISCONTINUE CHEMICAL TESTING FOR POTASSIUM CONCENTRATION IN MASTERMIXES.
P060030|S038|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2013|01/09/2014|||OK30|CHANGE TO DISCONTINUE CHEMICAL TESTING FOR POTASSIUM CONCENTRATION IN MASTERMIXES.
P110020|S011|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2013|01/09/2014|||OK30|CHANGE TO DISCONTINUE CHEMICAL TESTING FOR POTASSIUM CONCENTRATION IN MASTERMIXES.
P050028|S038|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2013|01/09/2014|||OK30|CHANGE TO DISCONTINUE CHEMICAL TESTING FOR POTASSIUM CONCENTRATION IN MASTERMIXES.
P050038|S019|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORRBABLE HEMOSTAT|LMG|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2013|02/27/2014|||APPR|APPROVAL FOR A LARGER (18 GRAM) BELLOW CONTAINER FOR THE 5 GRAM ARISTA AH DEVICE AND INCREASES IN THE DIMENSIONS OF THE DEVICE PACKAGING, SPECIFICALLY, THE FOIL AND TYVEK POUCHES AND SHELF AND SHIPPER BOXES.
P070015|S118|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2013|01/08/2014|||OK30|MODIFICATIONS TO THE SAMPLING PLAN FOR XIENCE FINAL RELEASE TESTING.
P110019|S059|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2013|01/08/2014|||OK30|MODIFICATIONS TO THE SAMPLING PLAN FOR XIENCE FINAL RELEASE TESTING.
P100026|S004|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/12/2013|02/24/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960058|S106|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM WITH THE NAIDA CI AQUACASE|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/13/2013|09/10/2014|||APPR|APPROVAL FOR THE NAIDA CI AQUACASE FOR USE WITH THE NAIDA CI Q70 SOUND PROCESSOR. THE NAIDA CI AQUACASE IS AN ACCESSORY TO THE HIRESOLUTION BIONIC EAR SYSTEM.
P890003|S294|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/13/2013|01/09/2014|||OK30|PROCESS CHANGE FOR THE MYCARELINK MONITOR SOLDER PROCESS.
P110020|S010|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS BRAF V600 MUTATION TEST|OWD|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2013|03/12/2014|||APPR|APPROVAL FOR CHANGES TO THE COBAS® 4800 SR2 SYSTEM SOFTWARE ARCHITECTURE AND ASSAY SPECIFIC ANALYSIS PACKAGE (ASAP) SOFTWARE FOR THE COBAS® BRAF V600 MUTATION TEST AND COBAS® EGFR MUTATION TEST.
P120019|S004|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|12/13/2013|03/12/2014|||APPR|APPROVAL FOR CHANGES TO THE COBAS 4800 SR2 SYSTEM SOFTWARE ARCHITECTURE AND ASSAY SPECIFIC ANALYSIS PACKAGE (ASAP) SOFTWARE FOR THE COBAS BRAF V600 MUTATION TEST AND COBAS EGFR MUTATION TEST.
P100026|S005|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEURO PACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/13/2013|02/18/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100026|S006|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/16/2013|02/14/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030017|S186|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2013|05/22/2014|||APPR|APPROVAL FOR DESIGN CHANGES TO PRECISION SPECTRA OR CABLE AND EXTENSION AND AN ALTERNATE QUALIFIED SUPPLIER (ONANON INC. MILPITAS, CA).
P060033|S085|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P030009|S073|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P110013|S032|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P090006|S012|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE ILIAC VASCULAR STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P110040|S002|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE SFA/PPA VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P010031|S413|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Programmer, pacemaker|BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE|KRG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2013|02/27/2014|||APPR|APPROVAL FOR POST STERILIZATION TEST FIRMWARE, PROGRAMMER APPLICATION SOFTWARE AND LABELING FOR THE  DEVICES.
P110011|S006|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P980016|S451|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD, VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2013|02/27/2014|||APPR|APPROVAL FOR POST STERILIZATION TEST FIRMWARE, PROGRAMMER APPLICATION SOFTWARE AND LABELING FOR THE  DEVICES.
P100040|S015|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P890003|S295|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK MONITOR,|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2013|02/27/2014|||APPR|APPROVAL FOR POST STERILIZATION TEST FIRMWARE, PROGRAMMER APPLICATION SOFTWARE AND LABELING FOR THE  DEVICES.
P100021|S031|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P070027|S037|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT AAA STENT GRAFT WITH XCELERANT HYRO DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2013|01/14/2014|||OK30|CHANGE TO YOUR BIOBURDEN TEST METHOD.
P040002|S045|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2013|02/06/2014|||APPR|APPROVAL FOR THE ADDITION OF A CONTRACT STERILIZER LOCATED AT STERIS-ISOMEDIX SERVICES,  IN TEMECULA, CALIFORNIA.
P980041|S027|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2013|05/01/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1.
P850048|S037|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2013|05/01/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1.
P970038|S026|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH  FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2013|05/01/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1.
P090026|S010|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2013|05/01/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1.
P910001|S069|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2013|01/14/2014|||OK30|MODIFICATIONS TO REDUCE THE FREQUENCY OF STERILE BARRIER STRENGTH TESTING AND A MODIFICATION TO THE PROCESS OF SEAL STRENGTH MONITORING.
P960042|S047|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATHS SLS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2013|01/14/2014|||OK30|MODIFICATIONS TO REDUCE THE FREQUENCY OF STERILE BARRIER STRENGTH TESTING AND A MODIFICATION TO THE PROCESS OF SEAL STRENGTH MONITORING.
P930039|S100|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2013|12/23/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE FOR THE DEVICES.
P890003|S296|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2013|12/23/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE FOR THE DEVICES.
P920015|S126|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2013|12/23/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE FOR THE DEVICES.
P900061|S125|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2013|12/23/2013|||OK30|UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE FOR THE DEVICES.
P000025|S074|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2013|01/17/2014|||OK30|CHANGES IN THE VACUUM BAKE-OUT PROCESS AND THE PREPARATION OF IN-PROCESS TEST SAMPLES.
P980044|S017|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2013|01/14/2014|||OK30|CONTRACT LABORATORY CHANGE.
P030011|S023|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2013|03/18/2014|||APPR|APPROVAL FOR A MINOR CHANGE TO THE COMPANION 2 DRIVER SYSTEMEXTERNAL BATTERY.
P030022|S028|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2013|01/13/2014|||OK30|CHANGE TO A DIFFERENT DETERGENT CHELATING AGENT.
P970021|S040|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2013|03/17/2014|||APPR|APPROVAL FOR A CHANGE TO THE HEATER WIRE SHRINK TUBING WITHIN THE BALLOON.
P100012|S005|NUVASIVE, INC.|7475 LUSK BLVD||SAN DIEGO|CA|92121||PROSTHESIS, INTERVERTEBRAL DISC|NUVASIVE PCM CERVICAL DISC SYSTEM|MJO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2013|03/07/2014|||APPR|APPROVAL FOR DESIGN CHANGES TO THE PCM INSERTER AND REDEFINING AND TIGHTENING IMPLANT TOLERANCES.
P010015|S227|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VIVA CRT-P,CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2013|07/09/2014|||APPR|APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA).
P890003|S297|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK ENORE PROGRAMMER,CARELINK 2090 PROGRAMMER,CARELINK HOME MONITOR,CARELINK EXPRESS MONITOR,CARDIOSIGHT READER,DEV|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2013|07/09/2014|||APPR|APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA).
P010031|S414|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONCERTO II CRT-D,MAXIMO II CRT-D,CONSULTA CRT-D,CONSULTA CRT-D DF4,MAXIMO II CRT-D DF4|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2013|07/09/2014|||APPR|APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA).
P980016|S452|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II DR,MAXIMO II VR,VIRTUOSO II VR,SECURA DR,SECURA VR|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2013|07/09/2014|||APPR|APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA).
P980035|S358|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR,ADVISA DR MRI|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2013|07/09/2014|||APPR|APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA).
P930014|S071|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF MONOFOCAL POSTERIOR INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/13/2014|||OK30|REDUCE FREQUENCY OF A MANUFACTURING INSPECTION FROM A 100% INSPECTION RATE TO A SAMPLE-BASED INSPECTION PLAN FOR DEVICES WITHIN A LOT.
P040020|S052|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR MULTIFOCAL POSTERIOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/13/2014|||OK30|REDUCE FREQUENCY OF A MANUFACTURING INSPECTION FROM A 100% INSPECTION RATE TO A SAMPLE-BASED INSPECTION PLAN FOR DEVICES WITHIN A LOT.
P010031|S415|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D; CONCERTO II CRT-D; CONSULTA ICD,MAXIMO II CRT-D, PROTECTA XI C RT-D, VIVA S/X CRT-D;||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P030053|S016|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORY GEL SILICONE GEL- FILLED BREAST IMPLANTS|FTR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2013|03/18/2014|||APPR|APPROVAL FOR THE ADDITION OF THIRTY-ONE STYLES INCLUDING SIXTEEN SMOOTH ROUND ULTRA HIGH PROFILE DEVICES: 350-5135BC, 350-5160BC, 350-5180BC, 350-5215BC, 350-5240BC, 350-5270BC, 350-5295BC, 350-5320BC, 350-5350BC, 350-5375BC, 350-5400BC, 350-5430BC, 350-5455BC, 350-5480BC, 350-5535BC, AND 350-5590BC; AND FIFTEEN SILTEX® ROUND ULTRA HIGH PROFILE DEVICES: 354-5135, 354-5160, 354-5185, 354-5215, 354-5240, 354-5270, 354-5295, 354-5320, 354-5350, 354-5375, 354-5400, 354-5430, 354-5455, 354-5480, AND 354-5535.
P980035|S359|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR/DR  MRI IPG; RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P970012|S094|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|APPLICATION SOFTWARE, EVERA S DR ICD, S VR ICD, XT VR DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD XT ICD, RV LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P990001|S116|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITA ENHANCR II|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P980050|S089|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|INCHECK PATIENT ASSISTANCE, TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P950024|S056|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P010015|S228|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P930014|S072|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|12/30/2013|||OK30|CHANGE IN CLEANING OPERATIONS OF INTRAOCULAR LENSES.
P040020|S053|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|12/30/2013|||OK30|CHANGE IN CLEANING OPERATIONS OF INTRAOCULAR LENSES.
P980016|S453|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR  , S VR XT DR , XT VR .  MAXIMO II , PROTECTA, XT ICD, RV, SECURA, VIRTUOSO II DR/VR ICDS/|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P090013|S123|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|APPLICATION SOFTWARE CAPSUREFIX MRI LEAD REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P030036|S068|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECT SECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P060039|S054|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD MODEL 4195|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P080006|S064|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD MODELS 4196, 4296 ,4396|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P820003|S126|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOSABLE EPG COVER; DUAL CHAMBER TEMPORARY PACEMANKER; SINGLE CHAMBER TEMPORARY PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P830061|S104|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE, SP, SP NOVUS LEADS, VITATRON CRYSTALLINE & EXCELLENCE PS LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P930029|S040|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF MARINR MC (7FR), RF MARINR 5FR, RF CONTACTR, RF CONDUCTR, RF ENHANCR II,|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P930039|S101|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX LEAD, CAPSUREFIX NOVUS, SUREFIX, & VITATRON CRYSTALLINE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P850089|S104|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P890003|S298|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD, CARELINK, ENCORE AND REVEAL PROGRAMMER, MONITOR READER & SOFTWARE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P900061|S126|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER, APPLICATION SOFTWARE, DEFRILLATION SUPPORT DEVICE (DISD) END CAP, EPICCARDIAL PATCH LEAD SIZILING SLEEVE UPS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P920015|S127|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO & TRANSVENE CS/SVC LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2013|01/16/2014|||OK30|RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.
P890003|S299|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2013|02/27/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
P980016|S454|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2013|02/27/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
P980035|S360|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA ,SENSIA IPG, ADVISA DR IPG.ADVISA DR MRI IPG,ENPULSE E1 IPG,ENPULSE E2 IPG, ENRHYTHM IPG,KAPPA D(KAPPA 700)|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2013|02/27/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
P010015|S229|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2013|02/27/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
P010031|S416|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|INSYNC II PROTECT ICD, INSYNC III MARQUIS ICD,INSYNC MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,CONCERTO ICD,CONCERTO II|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2013|02/27/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
P090013|S124|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2013|02/27/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
P000006|S035|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2013|01/17/2014|||OK30|CHANGE TO THE MOLD USED IN THE MANUFACTURE OF THE CONNECTOR SLEEVE.
P990052|S024|VIBRANT MED-EL HEARING TECHNOLOGY GMBH|FUERSTENWEG 77|A-6020|INNSBRUCK||||Implant, hearing, active, middle ear, partially implanted|VIBRANT SOUNDBRIDGE|MPV|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2013|02/13/2014|||OK30|USE OF AN ALTERNATE SUPPLIER OF BOND COATING MATERIAL, USE OF AN ALTERNATE WIRE SUPPLIER, AND CHANGES TO THE SLEEVE MANUFACTURING PROCESS.
P840062|S037|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2013|01/17/2014|||OK30|CHANGE TO INTRODUCE AN ALTERNATE TEST METHOD FOR BACTERIAL ENDOTOXIN IN COLLAGEN PRODUCTS.
P050051|S025|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2013|01/09/2014|||OK30|CHANGE TO THE PURIFICATION PROCESS FOR ANTIGENS USED IN THE MANUFACTURE OF THE ARCHITECT AUSAB ASSAY.
P910073|S122|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2013|11/06/2015|||APPR|APPROVAL FOR THE FOLLOWING:1) A STERILIZATION PROCESS CHANGE FROM OXYFUME TO 100% ETHYLENE OXIDE;2) DRUG SPECIFICATION CHANGES; AND3) CORRESPONDING LABELING CHANGES.
P810006|S050|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT , ABSORABLE COLLAGEN HEMOSTATIC SPONGE, INSTANT MCH MICROFIBRILLAR COLLAGEN HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2013|01/17/2014|||OK30|CHANGE TO INTRODUCE AN ALTERNATE TEST METHOD FOR BACTERIAL ENDOTOXIN IN COLLAGEN PRODUCTS.
P850010|S049|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2013|01/17/2014|||OK30|CHANGE TO INTRODUCE AN ALTERNATE TEST METHOD FOR BACTERIAL ENDOTOXIN IN COLLAGEN PRODUCTS.
P030022|S029|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFECTION CERAMIC HIP SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/20/2013|01/13/2014|||OK30|ADD NEW MANUFACTURING EQUIPMENT.
P100034|S008|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVO TTF-100A SYSTEM|NZK|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/24/2014|07/24/2014|||APPR|APPROVAL TO REPLACE THE CURRENT TYVEK POUCH PACKAGING MATERIAL FOR THE INE TRANSDUCER ARRAYS WITH AN ALUMINUM FOIL MOISTURE BARRIER AND TO EXTEND THE SHELF LIFE FOR THESE TRANSDUCER ARRAYS FROM 6 TO 9 MONTHS.
P070015|S119|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|05/29/2014|||APPR|APPROVAL FOR A CHANGE IN THE RESIN COMPOSITION OF POLYPROPYLENE SUPPLY ITEMS USED IN XIENCE PRIMER AND DRUG FORMULATION MANUFACTURING.
P110019|S060|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM,|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|05/29/2014|||APPR|APPROVAL FOR A CHANGE IN THE RESIN COMPOSITION OF POLYPROPYLENE SUPPLY ITEMS USED IN XIENCE PRIMER AND DRUG FORMULATION MANUFACTURING.
P980035|S361|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG, ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|NEW SUPPLIER FOR THE MOLDING COMPOUND USED IN THE MANUFACTURING OF CAPACITORS FOR THE HYBRID ASSEMBLIES.
P010015|S230|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|NEW SUPPLIER FOR THE MOLDING COMPOUND USED IN THE MANUFACTURING OF CAPACITORS FOR THE HYBRID ASSEMBLIES.
P090013|S125|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|NEW SUPPLIER FOR THE MOLDING COMPOUND USED IN THE MANUFACTURING OF CAPACITORS FOR THE HYBRID ASSEMBLIES.
P010030|S047|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|NEW SUPPLIER FOR THE THERAPY ELECTRODE GAS GENERATOR BASE AND THERAPY ELECTRODE GAS GENERATOR ENCLOSURE COVER.
P060033|S086|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|02/03/2014|||OK30|CHANGES TO AUTOMATE SELECT ANALYTICAL TESTING DOCUMENTATION PROCESSES.
P080025|S062|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL EXTENSIONS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P840001|S259|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|VECTRIS SURESCAN 1X8 LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P960009|S187|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS SYSTEMS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P970004|S166|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY EXTENSIONS AND LEADS|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P020004|S089|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/17/2014|||OK30|ALTERNATE PTFE RESIN.
P110042|S024|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|ADDITIONAL SYSTEM USED IN MANUFACTURING OPERATIONS FOR THE S-ICD® SYSTEM.
P010032|S074|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PROTEGE SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2013|03/21/2014|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI IPG TO PROTÉGÉ (MODEL 3789); LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI LE CHARGE TO PRODIGY CHARGER (MODEL 3730); AND MINOR SOFTWARE MODIFICATIONS TO THE PATIENT PROGRAMMER AND RAPID PROGRAMMER (MODEL 3852) TO RECOGNIZE THE DEVICE WITH THE NEW PROTÉGÉ DEVICE NAME AND MODEL NUMBER.
P100026|S007|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/24/2014|||OK30|IMPLEMENT A NEW DATABASE USED TO COLLECT AND STORE MANUFACTURING TEST DATA.
P110013|S033|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|02/03/2014|||OK30|CHANGES TO AUTOMATE SELECT ANALYTICAL TESTING DOCUMENTATION PROCESSES.
P890055|S053|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||APPR|APPROVAL FOR ADDITION OF A 100% INSPECTION TO VERIFY THE USE BY DATE ON THE LABELS OF THE MEDSTREAM IMPLANTABLE INFUSION PUMP SYSTEM.
P030017|S188|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER FOR THE FEEDTHROUGH COMPONENT.
P890003|S300|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR, MYCARELINK READER FRU|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/16/2014|||OK30|CHANGE IN THE TEST EQUIPMENT/TEST METHOD USED IN THE QUALITY CONTROL INSPECTION PROCESS OF THE PRINTED CIRCUIT BOARD ASSEMBLIES USED IN THE MYCARELINK PATIENTMONITOR.
P030017|S187|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/22/2014|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER FOR THE PRINTED CIRCUIT BOARD ASSEMBLY.
P980022|S150|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2013|03/13/2014|||APPR|APPROVAL FOR CHANGES TO THE STACK ASSEMBLIES AND BATTERY TUBE ASSEMBLY TO COMPLY WITH ROHS (RESTRICTION OF HAZARDOUS SUBSTANCES) REQUIREMENTS. THESE CHANGES INCLUDE CHANGES TO FIVE COMPONENTS ON THE STACK ASSEMBLY, A CHANGE IN MATERIAL FOR THE BARE PRINTED CIRCUIT BOARDS (PCBS) OF THE STACK ASSEMBLY AND BATTERY TUBE ASSEMBLY, AND A CHANGE TO THE SOLDER MATERIAL (FROM TIN/LEAD TO TIN/SILVER/COPPER) USED ON THE PCBS.
P120010|S008|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2013|03/13/2014|||APPR|APPROVAL FOR CHANGES TO THE STACK ASSEMBLIES AND BATTERY TUBE ASSEMBLY TO COMPLY WITH ROHS (RESTRICTION OF HAZARDOUS SUBSTANCES) REQUIREMENTS. THESE CHANGES INCLUDE CHANGES TO FIVE COMPONENTS ON THE STACK ASSEMBLY, A CHANGE IN MATERIAL FOR THE BARE PRINTED CIRCUIT BOARDS (PCBS) OF THE STACK ASSEMBLY AND BATTERY TUBE ASSEMBLY, AND A CHANGE TO THE SOLDER MATERIAL (FROM TIN/LEAD TO TIN/SILVER/COPPER) USED ON THE PCBS.
P030050|S019|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/23/2014|||OK30|CHANGES TO THE SIEVING YIELD RANGE AND A MODIFICATION OF THE STIRRING SYSTEM FOR CLOGGING TEST.
P010033|S023|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON -TB GOLD|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2013|01/31/2014|||OK30|CHANGES TO INCORPORATE NEW BRANDING IN THE LABELING, TIGHTEN AN IN-PROCESS QC SPECIFICATION FOR THE BLOOD COLLECTION TUBES, AND ADD STEPS TO A RAW MATERIAL ACCEPTANCE PROCEDURE.
P010015|S231|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P980035|S362|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG,ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P980050|S090|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P950024|S057|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P930039|S102|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P920015|S128|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD & HV SPLITTER/ADAPTOR KIT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P890003|S301|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P850089|S105|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P830061|S105|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P090013|S126|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD,REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P080006|S065|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P060039|S055|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P030036|S069|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/16/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P860057|S117|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/23/2014|||OK30|CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
P010041|S047|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS SAV AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/23/2014|||OK30|CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
P870056|S064|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/23/2014|||OK30|CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
P870077|S058|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS,  DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/23/2014|||OK30|CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
P000046|S022|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC II, SHELLGEL|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/23/2014|||OK30|ADDITION OF A NEW CANNULA SUPPLIER.
P990038|S019|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/10/2014|||OK30|MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.
P080007|S019|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT|NIO|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/22/2014|||APPR|APPROVAL FOR AN ADDITIONAL LABELING VERIFICATION INSPECTION METHOD FOR THE DEVICE PACKAGING.
P070014|S041|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2013|01/22/2014|||APPR|APPROVAL FOR AN ADDITIONAL LABELING VERIFICATION INSPECTION METHOD FOR THE DEVICE PACKAGING.
P980016|S455|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2013|03/05/2014|||APPR|APPROVAL FOR DESIGN CHANGES TO THE DIE STACK USED IN THE ICDS AND CRT-DS.
P010031|S417|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D,VIVA S CRT-D, VIVA XT CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/26/2013|03/05/2014|||APPR|APPROVAL FOR DESIGN CHANGES TO THE DIE STACK USED IN THE ICDS AND CRT-DS.
P100021|S032|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT II STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2013|09/03/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO EG, IN SONORA, MEXICO.
P050034|S013|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X|NCJ|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/26/2013|10/08/2014|||APPR|APPROVAL TO MODIFY THE INDICATIONS FOR USE FOR THE IMT TO INCLUDE PATIENTS 65 TO 74 YEARS OF AGE FROM THE CURRENT MINIMUM OF 75 YEARS, TO REVISE THE PROFESSIONAL AND PATIENT LABELING TO UPDATE THE DATA BASED ON THE RESULTS OUT TO 8-YEARS POST IMT IMPLANTATION, AND TO REVISE THE ACCEPTANCE OF RISK AND INFORMED DECISION AGREEMENT, AS WELL AS THE PROFESSIONAL AND PATIENT LABELING, TO EMPHASIZE THAT THE LONGER THE IMT IS IN THE EYE, THE GREATER THE POTENTIAL RISK OF DEVELOPING VISION-IMPAIRING CORNEAL EDEMA WHICH MAY LEAD TO THE NEED FOR CORNEAL TRANSPLANT AND POSSIBLE TELESCOPE REMOVAL.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMPLANTABLE MINIATURE TELESCOPETM (BY DR. ISAAC LIPSHITZ) (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X AND IS INDICATED FOR MONOCULAR IMPLANTATION TO IMPROVE VISION IN PATIENTS GREATER THAN OR EQUAL TO 65 YEARS OF AGE WITH STABLE SEVERE TO PROFOUND VISION IMPAIRMENT (BEST CORRECTED DISTANCE VISUALACUITY 20/160 TO 20/800) CAUSED BY BILATERAL CENTRAL SCOTOMAS ASSOCIATED WITH END-STAGE AGE-RELATED MACULAR DEGENERATION. PATIENTS MUST:1) HAVE RETINAL FINDINGS OF GEOGRAPHIC ATROPHY OR DISCIFORM SCAR WITH FOVEAL INVOLVEMENT, AS DETERMINED BY FLUORESCEIN ANGIOGRAPHY; 2) HAVE EVIDENCE OF VISUALLY SIGNIFICANT CATARACT (>= GRADE 2); 3) AGREE TO UNDERGO PRE-SURGERY TRAINING AND ASSESSMENT (TYPICALLY 2 TO 4 SESSIONS) WITH LOW VISION SPECIALISTS (OPTOMETRIST OR OCCUPATIONAL THERAPIST) IN THE USE OF AN EXTERNAL TELESCOPE SUFFICIENT FOR PATIENT ASSESSMENT AND FOR THE PATIENT TO MAKE AN INFORMED DECISION; 4) ACHIEVE AT LEAST A 5-LETTER IMPROVEMENT ON THE ETDRS CHART WITH AN EXTERNAL TELESCOPE; 5) HAVE ADEQUATE PERIPHERAL VISION IN THE EYE NOT SCHEDULED FOR SURGERY; AND 6) AGREE TO PARTICIPATE IN POSTOPERATIVE VISUAL TRAINING WITH A LOW VISION SPECIALIST.
P990046|S037|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE AND AORTIC VALVE GRAFT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2013|01/24/2014|||OK30|ALTERNATIVE TO BATCH TESTING FOR BACTERIAL ENDOTOXIN TESTING (BET).
P050028|S039|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0,COBAS AMPLIPREP/COBAS TAQMAN WASH REAGENT|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2013|01/23/2014|||OK30|CHANGE TO DISCONTINUE IN-PROCESS TESTING FOR PH AND VISUAL INSPECTION FOR A VIALED COMPONENT.
P040044|S050|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2013|01/24/2014|||OK30|CHANGES TO THE HYDROGEL DRYING PROCESS.
P000046|S021|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC, OPTIVISC, AND ANIKAVISC SODIUM HYALURONATE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/26/2013|01/24/2014|||OK30|CHANGE TO THE MANUFACTURING PROCESS WITH REGARD TO THE DEVICE¿S PACKAGING.
P010068|S038|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR RMT DS ,EZ STEER NAV DS ,CELSIUS FLTR, CELSIUS DS, & NAVISTAR DS CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/24/2014|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
P990081|S025|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEW (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/22/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR PCBAS (PRINTED CIRCUIT BOARD ASSEMBLIES) USED IN THE MANUFACTURE OF THE BENCHMARK ULTRA INSTRUMENT.
P100027|S014|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/22/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR PCBAS (PRINTED CIRCUIT BOARD ASSEMBLIES) USED IN THE MANUFACTURE OF THE BENCHMARK ULTRA INSTRUMENT.
P030031|S058|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELCIUS/ RMT THERMOCOOL ,NAVISTAR THERMOCOOL ,NAVISTAR RMT THERMOCOOL, THERMOCOOL, EZ STEER THERMOCOOL SF CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/24/2014|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
P040036|S041|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV  CATH|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/24/2014|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
P950005|S049|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/24/2014|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
P990025|S039|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV  CATHETERS AND,BIOSENSE WEBSTER CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/24/2014|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
P990071|S025|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|BIOSENSE WEBSTER CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/24/2014|||OK30|CHANGE IN THE STERILIZATION RELEASE METHOD FOR BIOSENSE WEBSTER CATHETERS AND CABLES.
P990041|S018|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/10/2014|||OK30|MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.
P990042|S015|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/10/2014|||OK30|MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.
P990043|S019|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/10/2014|||OK30|MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.
P990044|S016|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/10/2014|||OK30|MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.
P990045|S016|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/27/2013|01/10/2014|||OK30|MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.
P010047|S032|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT WITH RECOMBINANT HUMAN ALBUMIN|NBE|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/30/2013|04/15/2016|||APPR|Approval to add a model that changes the source material for the protein solution from Human Serum Albumin (HSA) to recombinant Human Albumin (rHA for the Progel® Pleural Air Leak Sealant (PALS) with Recombinant Human Albumin (rHA) .
P090003|S030|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2013|01/29/2014|||OK30|REMOVE THE METALS CONTENT LOAD TEST USED FOR THE MONITORING OF ELECTROPOLISHING SOLUTIONS.
P020009|S114|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2013|01/29/2014|||OK30|REMOVE THE METALS CONTENT LOAD TEST USED FOR THE MONITORING OF ELECTROPOLISHING SOLUTIONS.
P040016|S120|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2013|01/29/2014|||OK30|REMOVE THE METALS CONTENT LOAD TEST USED FOR THE MONITORING OF ELECTROPOLISHING SOLUTIONS.
P060006|S053|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2013|01/29/2014|||OK30|REMOVE THE METALS CONTENT LOAD TEST USED FOR THE MONITORING OF ELECTROPOLISHING SOLUTIONS.
P950039|S027|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP SLIDES|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2013|01/29/2014|||OK30|ADDITION OF A SPECIFICATION ON MINIMUM CELL TRANSFER REQUIREMENTS FOR THE THINPREP MICROSCOPE SLIDES.
P010047|S033|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2013|01/27/2014|||OK30|ADDITION OF A SECOND SOURCE COMPONENT SUPPLIER.
P990074|S028|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/31/2013|03/27/2014|||APPR|APPROVAL FOR A CHANGE TO THE MATERIAL USED FOR THE FILL TUBE TIP ANDLUER ADAPTER OF THE FILL TUBE ASSEMBLY FOR NATRELLE SALINE-FILLED BREAST IMPLANTS FROM PRO-FAX PD626 POLYPROPYLENE HOMOPOLYMER TO P5M6K-080 POLYPROPYLENE COPOLYMER.
P960043|S085|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE AND PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEMS|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2013|01/29/2014|||OK30|CHANGE TO THE JOINT TENSILE TESTING PROCESS.
P040046|S005|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE- FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|01/02/2014|09/19/2014|||APPR|APPROVAL FOR LABELING DOCUMENTS FOR THE NATRELLE® 410 HIGHLY COHESIVEANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS CONTAINING 10-YEAR DATA FROM THE FINAL POSTAPPROVAL STUDY REPORT.
P960043|S086|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE/PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2014|01/30/2014|||OK30|ADDITIONAL TESTING APPARATUS AND PROCEDURE BE INCLUDED IN THE FUNCTIONAL TESTING PERFORMED ON THE GATED SUTURE TRIMMER.
N16895|S095|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2014|06/06/2014|||APPR|APPROVAL FOR A NEW UV BULB.
P900056|S130|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/03/2014|01/30/2014|||OK30|CHANGE TO THE LONG DRIVE LASER WELDER EQUIPMENT USED IN THE ROTALINK LONG DRIVE SUB-ASSEMBLY LINE.
P010032|S075|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON CHARGING SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/03/2014|07/02/2014|||APPR|APPROVAL FOR HARDWARE AND SOFTWARE MODIFICATIONS TO THE EON CHARGING SYSTEM MODEL 3726.
P990081|S026|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2014|01/23/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR A SUBASSEMBLY USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.
P040002|S046|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2014|06/18/2014|||APPR|APPROVAL FOR A MODIFIED EPTFE GRAFT MANUFACTURING PROCESS.
P100027|S015|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2014|01/23/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR A SUBASSEMBLY USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.
P020055|S013|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2014|01/23/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR A SUBASSEMBLY USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.
P040037|S061|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS|NIP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2014|03/10/2014|||APPR|APPROVAL FOR REVISED SPECIFICATION LIMITS FOR MANUFACTURING AIDS.
P900033|S033|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE|MDD|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2014|04/07/2014|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE INTEGRA® DERMAL REGENERATIONTEMPLATE. THE DESIGN CHANGE WAS TO PRODUCE A MESHED VERSION OF THE INTEGRA® DERMAL REGENERATION TEMPLATE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INTEGRA® MESHED DERMAL REGENERATION TEMPLATE AND IS INDICATED FOR THE POST EXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL THERMAL INJURIES WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT.  IT IS ALSO INDICATED FOR THE REPAIR OF SCAR CONTRACTURES WHEN OTHER THERAPIES HAVE FAILED OR WHEN DONOR SITES FOR REPAIR ARE NOT SUFFICIENT OR DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT.
P980007|S033|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2014|02/03/2014|||OK30|CHANGE TO THE QUALITY CONTROL TESTING USED ON IN-PROCESS MATERIALS.
P910007|S042|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2014|02/03/2014|||OK30|CHANGE TO THE QUALITY CONTROL TESTING USED ON IN-PROCESS MATERIALS.
P050037|S046|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2014|02/27/2014|||APPR|APPROVAL FOR IN-SOURCING TESTING OF A RAW MATERIAL COMPONENT OF THE RADIESSE PRODUCT.
P020045|S051|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2014|02/07/2014|||OK30|CHANGES TO MANUFACTURING EQUIPMENT AND MANUFACTURING EQUIPMENT SOFTWARECHANGES SUPPORTING A WINDOWS 7 OPERATING SYSTEM UPGRADE.
P100010|S033|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARTIC FRONT CARDIC CRYOABLATION CATHETERS, ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARIAC CRYOAB|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2014|02/07/2014|||OK30|CHANGES TO MANUFACTURING EQUIPMENT AND MANUFACTURING EQUIPMENT SOFTWARECHANGES SUPPORTING A WINDOWS 7 OPERATING SYSTEM UPGRADE.
P090006|S013|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM-ILIAC|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2014|02/05/2014|||OK30|MANUFACTURING TRANSFER OF A CRITICAL MANUFACTURING AID.
P110040|S003|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2014|02/05/2014|||OK30|MANUFACTURING TRANSFER OF A CRITICAL MANUFACTURING AID.
P100023|S083|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2014|02/06/2014|||OK30|CHANGE TO THE  DELIVERY CATHETER ASSEMBLY MANUFACTURING PROCESS.
P040047|S033|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2014|02/04/2014|||OK30|IN-SOURCING TESTING OF A RAW MATERIAL COMPONENT OF THE COAPTITE PRODUCT.
P050052|S050|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2014|02/27/2014|||APPR|APPROVAL FOR IN-SOURCING TESTING OF A RAW MATERIAL COMPONENT OF THE RADIESSE PRODUCT.
P020025|S052|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2014|02/07/2014|||OK30|AUTOMATE AND MOVE AN EXTRUSION PROCESS FOR THE BLAZER PRIME XP & INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS TO A DIFFERENT MANUFACTURING LINE.
P990064|S053|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC  PORCINE BIOPROSTHESIS|LWR|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2014|02/05/2014|||APPR|APPROVAL FOR THE INCLUSION OF AN INDEXED EFFECTIVE ORIFICE AREA (IEOA) SIZING CHART IN THE IFU AND AN UPDATE TO THE SIZERS TO ALIGN WITH THE UPDATED IEOA SIZING CHART.
P010031|S418|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2014|02/04/2014|||OK30|CHANGE IN THE INSPECTION AND MANUFACTURING PROCESSES IN THE CATHODE MIX FOR THE IMPLANTABLE PULSE GENERATOR BATTERY.
P980016|S456|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2014|02/04/2014|||OK30|CHANGE IN THE INSPECTION AND MANUFACTURING PROCESSES IN THE CATHODE MIX FOR THE IMPLANTABLE PULSE GENERATOR BATTERY.
P110042|S025|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANCOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2014|01/31/2014|||OK30|USE OF A TWO-PART EPOXY ON THE HIGH VOLTAGE CAPACITOR USED IN THE S-ICD SYSTEM.
P950029|S086|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/10/2014|03/18/2014|||APPR|APPROVAL FOR UPDATED ORCHESTRA/ORCHESTRA PLUS PROGRAMMERSOFTWARE, REPLY 1.16 AND PACEART 1.12.
P980049|S090|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM ICD|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/10/2014|03/18/2014|||APPR|APPROVAL FOR UPDATED ORCHESTRA/ORCHESTRA PLUS PROGRAMMERSOFTWARE, REPLY 1.16 AND PACEART 1.12.
P050023|S075|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|LUMAX 6/7  AND ILESTO/IFORIA ICD/CRT D FAMILIES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/10/2014|03/11/2014|||APPR|APPROVAL FOR A MODIFICATION TO COUPLING CAPACITORS IN THE ELECTRONIC MODULES USED IN THE DEVICES.
P100047|S034|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2014|02/06/2014|||OK30|IMPLEMENTATION OF A RE-WORK PROCESS FOR THE PUMPS.
P000053|S050|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|01/10/2014|06/16/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE PHYSICIAN LABELING TO SUMMARIZE THE RESULTS OF THE INHIBIZONE POST-APPROVAL STUDY
P010032|S076|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON CTM IPG NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/10/2014|04/25/2014|||APPR|VAPPROVAL FOR PACKAGING MODIFICATIONS TO REMOVE THE MODEL 3009 TRIAL CABLE FROM APPROVED SJM LEADS AND EXTENSIONS.
P910023|S325|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2014|02/06/2014|||OK30|CHANGE IN THE HYDROHONE PROCESS.
P030054|S256|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY, UNIFY ASSURA, UNIFY QUADRA AND QUADRA ASSURA CRT-D'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2014|02/06/2014|||OK30|CHANGE IN THE HYDROHONE PROCESS.
P110019|S061|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/13/2014|03/26/2014|||APPR|APPROVAL FOR A LABELING CHANGE FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND THE XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM FOR THE OTW PLATFORM. THIS LABELING CHANGE REQUESTED A SHELF LIFE EXTENSION FROM 24 TO 36 MONTHS.
P990013|S033|STARR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||intraocular lens|STAAR SURGICAL COLLAMER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2014|02/10/2014|||OK30|NEW MANUFACTURING FILTER.
P030016|S026|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2014|02/10/2014|||OK30|NEW MANUFACTURING FILTER.
P900056|S131|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPASTY SYSTEM GUIDEWIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P920047|S065|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P050047|S034|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/11/2014|||OK30|USE OF IN-HOUSE LABORATORY FOR BACTERIAL IDENTIFICATION TESTING.
P980003|S046|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P020009|S115|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER THE WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P110033|S003|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/11/2014|||OK30|USE OF IN-HOUSE LABORATORY FOR BACTERIAL IDENTIFICATION TESTING.
P020025|S053|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II  XPCARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P030025|S101|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P040016|S121|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P060006|S054|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P060008|S108|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P100023|S084|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING C ORONAY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P110010|S065|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS- ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/13/2014|||OK30|EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
P110042|S026|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR ( S-ICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/07/2014|||OK30|IMPLEMENT A HIGH POWER HYBRID (HPH) RESISTANCE SCREENING SYSTEM AND REWORK PROCESS AT THE HPH SUPPLIER.
P100023|S085|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/06/2014|||OK30|CHANGE TO THE FOREIGN MATERIAL REMOVAL STEP.
P110010|S066|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/06/2014|||OK30|CHANGE TO THE FOREIGN MATERIAL REMOVAL STEP.
P100047|S035|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/2014|04/10/2014|||APPR|APPROVAL FOR A NEW MATERIAL FOR THE ELECTRICAL CABLE OUTER JACKET AND CONNECTOR BOOT OF THE DRIVELINE EXTENSION CABLE.
P040043|S060|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GODRE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/14/2014|06/04/2014|||APPR|APPROVAL FOR A MODIFICATION TO THE DESTRUCTIVE TESTING SAMPLING PLAN AND CHANGE IN THE DEPLOYMENT FORCE SPECIFICATION.
P090016|S008|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE DERMAL FILLER|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/14/2014|04/10/2014|||APPR|APPROVAL FOR A CHANGE TO THE TIP CAP MATERIAL.
P940015|S031|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2014|02/12/2014|||OK30|CHANGE IN FINAL PACKAGING EQUIPMENT.
P100041|S047|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/15/2014|02/12/2014|||APPR|APPROVAL FOR THE ADDITION OF LABELING TO INDICATE THE CONTENTS OF DRY NATURAL RUBBER IN THE DEVICE PACKAGING.
P110021|S034|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/15/2014|02/12/2014|||APPR|APPROVAL FOR THE ADDITION OF LABELING TO INDICATE THE CONTENTS OF DRY NATURAL RUBBER IN THE DEVICE PACKAGING.
P020045|S052|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER, ETRA SURGICAL CARDIAC CRYOABLATION DEVICE, MAX SURGICAL CARDIAC CRYOABLATION DEVI|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2014|02/07/2014|||OK30|TWO ADDITIONAL STERILIZATION CHAMBERS IN THE STERIGENICS EO FACILITY IN TORONTO, CANADA.
P100010|S034|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCED CARDIAC CRYOABALATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2014|02/07/2014|||OK30|TWO ADDITIONAL STERILIZATION CHAMBERS IN THE STERIGENICS EO FACILITY IN TORONTO, CANADA.
P100023|S086|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE -WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2014|02/06/2014|||OK30|REPLACEMENT OF A CAMERA IN THE CATHETER INSPECTION PROCESS.
P110010|S067|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OTW)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2014|02/06/2014|||OK30|REPLACEMENT OF A CAMERA IN THE CATHETER INSPECTION PROCESS.
P020009|S116|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS/EXPRESS2 MONORAIL AND OVER-THE-WIRE CONRONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2014|02/06/2014|||OK30|REPLACEMENT OF A CAMERA IN THE CATHETER INSPECTION PROCESS.
P040016|S122|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2014|02/06/2014|||OK30|REPLACEMENT OF A CAMERA IN THE CATHETER INSPECTION PROCESS.
P970051|S114|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|01/15/2014|04/14/2014|||APPR|APPROVAL FOR MARKETING AN ACCESSORY, THE AQUA+, FOR USE WITH THE NUCLEUS 5 CP810 AND NUCLEUS 6 CP910/CP920 SOUND PROCESSORS, WHICH ARE CURRENTLY APPROVED FOR USE WITH THE COCHLEAR IMPLANT SYSTEM.
P000046|S023|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|NUVISC|LZP|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/15/2014|04/10/2014|||APPR|APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUVISCTM AND IS INDICATED FOR USE DURING SURGERY IN THE ANTERIOR AND POSTERIOR SEGMENTS OF THE HUMAN EYE. PROCEDURES INCLUDE: CATARACT EXTRACTION, INTRAOCULAR LENS (IOL) IMPLANTATION, CORNEAL TRANSPLANTATION SURGERY, GLAUCOMA FILTERING SURGERY, AND SURGICAL PROCEDURES TO REATTACH THE RETINA.
P960058|S107|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2014|02/14/2014|||OK30|AUTOMATION OF AN IN-PROCESS CONTINUITY TEST.
P030002|S029|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|CRYSTALENS  ACCOMMODATING INTRAOCULAR LENS (IOL) AND TRULIGN TORIC POSTERIOR CHAMBER IOL|MJP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2014|02/13/2014|||OK30|MANUFACTURING CHANGE TO THE TUMBLING PROCESS.
P100044|S015|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL AND PROPEL MINI SINUS IMPLANTS|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2014|02/11/2014|||OK30|ALTERNATE SUPPLIER BE CLEARED.
P020056|S024|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2014|02/14/2014|||OK30|CHANGE IN THE STERILIZATION VALIDATION METHOD, INCLUDING A CHANGE IN THE D-VALUE OF THE BIOLOGICAL INDICATORS AND A CHANGE IN THE VALIDATION PROTOCOL METHOD.
P040046|S006|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2014|02/14/2014|||OK30|CHANGE IN THE STERILIZATION VALIDATION METHOD, INCLUDING A CHANGE IN THE D-VALUE OF THE BIOLOGICAL INDICATORS AND A CHANGE IN THE VALIDATION PROTOCOL METHOD.
P100026|S008|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2014|02/14/2014|||OK30|UPDATE THE HARDWARE AND SOFTWARE PLATFORM OF AUTOMATED TEST EQUIPMENT.
P020004|S091|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2014|02/21/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL SEWING MACHINE FOR MANUFACTURE OF THE EXCLUDER AAA ENDOPROSTHESIS.
P950020|S067|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|FLEXTOME CUTTING BALLOON DILATATION DEVICE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2014|02/13/2014|||OK30|ADD A FIXTURE TO THE LASER USED IN THE HYPOTUBE-COREWIRE LASER BONDING STEP OF THE BALLOON CATHETER MANUFACTURING PROCESS.
P100023|S087|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2014|02/13/2014|||OK30|ADD A FIXTURE TO THE LASER USED IN THE HYPOTUBE-COREWIRE LASER BONDING STEP OF THE BALLOON CATHETER MANUFACTURING PROCESS.
P110010|S068|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/17/2014|02/13/2014|||OK30|ADD A FIXTURE TO THE LASER USED IN THE HYPOTUBE-COREWIRE LASER BONDING STEP OF THE BALLOON CATHETER MANUFACTURING PROCESS.
P110006|S002|U-SYSTEMS, INC.|9900 WEST INNOVATIVE DRIVE|MAIL STOP RP2138|WAUWATOSA|WI|53226||Automated breast ultrasound|INVENIA ABUS|PAA|RA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/17/2014|02/11/2014|||APPR|APPROVAL FOR CHANGE IN THE LABELING MATERIALS (REVISED SCAN STATION USER¿S MANUAL, WORKSTATION USER¿S MANUAL, AND USER TRAINING PROGRAM, AS WELL AS NEW PATIENT POSITIONING GUIDE, QUICK REFERENCE GUIDE ¿ POSITIONING, PRODUCT DATASHEET, AND BASIC SERVICE MANUAL).
P970051|S115|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/21/2014|||OK30|ADDITIONAL CIRCUIT BOARD SUPPLIER.
P100047|S036|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/21/2014|||OK30|USE OF AN ALTERNATE SUPPLIER FOR AN ALTERNATE MOSFET USED IN THE HEARTWARE VENTRICULAR ASSIST SYSTEM.
P060037|S029|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX / LPS-MOBILE BEARING KNEES|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/21/2014|||OK30|CHANGE TO MODIFY THE FINAL CLEANING PROCESS.
P980035|S363|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/04/2014|||OK30|ALTERNATE MANUFACTURING FACILITY OF EXISTING SUPPLIER, AND UTILIZATION OF SUPPLIER QUALITY MANAGEMENT (SQM) AS THE INCOMING INSPECTION CONTROL FOR THERMOFORMED BLISTER TRAYS.
P830061|S106|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/04/2014|||OK30|ALTERNATE MANUFACTURING FACILITY OF EXISTING SUPPLIER, AND UTILIZATION OF SUPPLIER QUALITY MANAGEMENT (SQM) AS THE INCOMING INSPECTION CONTROL FOR THERMOFORMED BLISTER TRAYS.
P090013|S127|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/04/2014|||OK30|ALTERNATE MANUFACTURING FACILITY OF EXISTING SUPPLIER, AND UTILIZATION OF SUPPLIER QUALITY MANAGEMENT (SQM) AS THE INCOMING INSPECTION CONTROL FOR THERMOFORMED BLISTER TRAYS.
P930039|S103|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/04/2014|||OK30|ALTERNATE MANUFACTURING FACILITY OF EXISTING SUPPLIER, AND UTILIZATION OF SUPPLIER QUALITY MANAGEMENT (SQM) AS THE INCOMING INSPECTION CONTROL FOR THERMOFORMED BLISTER TRAYS.
P990075|S025|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/20/2014|||OK30|ADD AN ADDITIONAL SUPPLIER FOR COMPONENTS USED IN THE MANUFACTURE OF MENTOR¿S SALINE-FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS.
P030050|S020|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA  & SCULPTRA AESTHETIC ( INJECTABLE POLY-L LACTIC ACID)|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/19/2014|||OK30|REPLACEMENT OF THE RADIATION SOURCE AND SUBSEQUENT REQUALIFICATION OF THE RADIATION PROCESS AT THE FIRM¿S CONTRACT STERILIZER FACILITY.
P080006|S066|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/18/2014|||OK30|MINOR CHANGES ASSOCIATED WITH THE CONNECTOR LABEL OF THE LEADS.
P010030|S048|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/21/2014|||OK30|IMPLEMENTATION OF THE IN CIRCUIT TEST (ICT) FIXTURE FOR ELECTRICAL TESTING OF THE PRINTED CIRCUIT ASSEMBLY (PCA) OF THE LIFEVEST 4000 BATTERY CHARGER/ MODEM¿S BEDSIDE PCA.
P100025|S006|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)|OZA|MI|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|01/22/2014|02/19/2014|||APPR|APPROVAL FOR THE CHANGES TO THE RELEASING SPECIFICATION FOR 13C-UREA TO COMPLY WITH THE USP MONOGRAPH CHANGES.
P990081|S027|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2014|04/09/2014|||APPR|APPROVAL FOR ADDITION OF A CURRENT SENSE PRINTED CIRCUIT BOARD (PCB) TO THE BENCHMARK ULTRA INSTRUMENT THAT WILL PREVENT AN OVERCURRENT SITUATION.
P100027|S016|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2014|04/09/2014|||APPR|APPROVAL FOR ADDITION OF A CURRENT SENSE PRINTED CIRCUIT BOARD (PCB) TO THE BENCHMARK ULTRA INSTRUMENT THAT WILL PREVENT AN OVERCURRENT SITUATION.
P050047|S035|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2014|02/21/2014|||OK30|USE OF A TEMPORARY WAREHOUSE FOR THE STORAGE OF RAW MATERIALS, PACKAGING ITEMS, AND FINISHED PRODUCTS.
P110033|S004|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2014|02/21/2014|||OK30|USE OF A TEMPORARY WAREHOUSE FOR THE STORAGE OF RAW MATERIALS, PACKAGING ITEMS, AND FINISHED PRODUCTS.
P980016|S457|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/18/2014|||OK30|UPDATES TO THE MANUFACTURING SOFTWARE USED TO CONTROL THE BATTERY CASE-COVER WELD PROCESS.
P010031|S419|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2014|02/18/2014|||OK30|UPDATES TO THE MANUFACTURING SOFTWARE USED TO CONTROL THE BATTERY CASE-COVER WELD PROCESS.
P910023|S327|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, ELLIPSE, FORTIFY, FORTIFYASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2014|02/18/2014|||OK30|XTS ANODE FOIL ETCHING ADDITIVE FOR MANUFACTURING OF THE HIGH VOLTAGE CAPACITORS FOR THE DEVICES.
P030054|S258|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, QUADRA ASSURA, UNITY, UNITY ASSURA, UNIFY QUADRA FAMILIES CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2014|02/18/2014|||OK30|XTS ANODE FOIL ETCHING ADDITIVE FOR MANUFACTURING OF THE HIGH VOLTAGE CAPACITORS FOR THE DEVICES.
P060033|S087|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2014|02/21/2014|||OK30|INTRODUCE AN UPGRADED LASER ABLATION MACHINE WITH INTEGRATED AUTOMATED HANDLING FOR THE HYPOTUBE COMPONENT.
P020050|S015|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2014|04/10/2014|||APPR|APPROVAL FOR AN ALTERNATE MODIFIED PATIENT SWIVEL BED FOR USE WITH THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE MODIFICATIONS ALLOW THE PATIENT BED TO BE USED WITH FEMTOSECOND LASERS OTHER THAN THE WAVELIGHT FS200 LASER TO CREATE THE FLAP FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK).
P030008|S013|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/22/2014|04/10/2014|||APPR|APPROVAL FOR AN ALTERNATE MODIFIED PATIENT SWIVEL BED FOR USE WITH THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE MODIFICATIONS ALLOW THE PATIENT BED TO BE USED WITH FEMTOSECOND LASERS OTHER THAN THE WAVELIGHT FS200 LASER TO CREATE THE FLAP FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK).
P900060|S053|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2014|02/20/2014|||OK30|MODIFIED IN-PROCESS INSPECTION FOR DETECTION OF MATERIAL DEPOSITS.
P010031|S420|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2014|04/11/2014|||APPR|APPROVAL FOR UPDATES TO THE HYBRID TEST PROCESS.
P980016|S458|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2014|04/11/2014|||APPR|APPROVAL FOR UPDATES TO THE HYBRID TEST PROCESS.
P880086|S238|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY,SUSTAINXL,VERITY,VICTORY,ZEPHYR,ACCENT FAMILIES OF PACEMAKER DEVICES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2014|03/31/2014|||APPR|APPROVAL FOR A MODIFICATION IN THE SEPARATOR COMPONENT UTILIZED IN THE BATTERIES OF THE IMPLANTABLE PULSE GENERATORS.
P030035|S116|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM FAMILY OF CRT-P DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2014|03/31/2014|||APPR|APPROVAL FOR A MODIFICATION IN THE SEPARATOR COMPONENT UTILIZED IN THE BATTERIES OF THE IMPLANTABLE PULSE GENERATORS.
P910023|S328|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2014|03/31/2014|||APPR|
P030054|S259|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE,QUADRA ASSURA,UNIFY,UNIFY ASSURA,UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2014|03/31/2014|||APPR|APPROVAL FOR A MODIFICATION IN THE SEPARATOR COMPONENT UTILIZED IN THE BATTERIES OF THE IMPLANTABLE PULSE GENERATORS.
P110002|S004|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2014|02/21/2014|||OK30|SUPPLIER CHANGE.
P110009|S004|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2014|02/21/2014|||OK30|SUPPLIER CHANGE.
P040037|S062|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/24/2014|04/02/2014|||APPR|APPROVAL FOR THE ADDITION OF RADIOPAQUE MARKERS TO THE ENDOPROSTHESIS AND A REVISED END TAPE.
P100026|S009|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/24/2014|02/21/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE MOLDED STYLET RETAINER.
P970051|S116|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS CI512 COCHLEAR IMPLANT|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2014|01/22/2015|||APPR|Approval for a manufacturing site located at Cochlear Limited - Macquarie, 1 University Avenue, Macquarie University, NSW 2109, Australia.
P980035|S364|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2014|02/18/2014|||OK30|SOFTWARE MODIFICATIONS FOR DISTRIBUTION CONTROL SORTER TOOL (DCST) SYSTEM FOR THE DEVICES.
P000058|S056|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2014|07/15/2015|||APPR|APPROVAL FOR INCREASING THE BIOREACTOR USED TO MANUFACTURE RHBMP-2 FROM 2500 L TO 6000 L AT THE PFIZER ANDOVER FACILITY BUILDING B.
P000054|S042|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2014|07/15/2015|||APPR|APPROVAL FOR INCREASING THE BIOREACTOR USED TO MANUFACTURE RHBMP-2 FROM 2500 L TO 6000 L AT THE PFIZER ANDOVER FACILITY BUILDING B.
P050053|S033|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2014|07/15/2015|||APPR|APPROVAL FOR INCREASING THE BIOREACTOR USED TO MANUFACTURE RHBMP-2 FROM 2500 L TO 6000 L AT THE PFIZER ANDOVER FACILITY BUILDING B.
P830055|S141|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2014|04/25/2014|||APPR|APPROVAL FOR THE ADDITION OF TRUMATCH RESECTION GUIDES FOR USE WITHAPPROVED  COMPONENTS (ATTUNE ROTATING PLATFORM TIBIAL AND FEMORAL COMPONENTS).
P850064|S026|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2014|02/19/2014|||OK30|ADDITION OF A NEW ULTRASONIC WELDER.
P050023|S076|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2014|07/03/2014|||APPR|APPROVAL FOR THE DF4 VARIANTS OF THE CURRENTLY APPROVED ILESTO/IFORIAICDS/CRT-DS AND LINOXSMART ICD LEADS.
P030017|S189|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2014|02/25/2014|||OK30|UTILIZE AN ALTERNATE TEST EQUIPMENT SYSTEM FOR FUNCTIONALITY TESTING.
P980023|S057|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|PROTEGO FAMILY OF ICD LEADS|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2014|07/03/2014|||APPR|APPROVAL FOR THE DF4 VARIANTS OF THE CURRENTLY APPROVED ILESTO/IFORIAICDS/CRT-DS AND LINOXSMART ICD LEADS.
P010031|S421|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2014|02/18/2014|||OK30|SOFTWARE MODIFICATIONS FOR DISTRIBUTION CONTROL SORTER TOOL (DCST) SYSTEM FOR THE DEVICES.
P010015|S232|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2014|02/18/2014|||OK30|SOFTWARE MODIFICATIONS FOR DISTRIBUTION CONTROL SORTER TOOL (DCST) SYSTEM FOR THE DEVICES.
P090013|S128|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2014|02/18/2014|||OK30|SOFTWARE MODIFICATIONS FOR DISTRIBUTION CONTROL SORTER TOOL (DCST) SYSTEM FOR THE DEVICES.
P980016|S459|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2014|02/18/2014|||OK30|SOFTWARE MODIFICATIONS FOR DISTRIBUTION CONTROL SORTER TOOL (DCST) SYSTEM FOR THE DEVICES.
P980022|S151|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2014|02/27/2014|||OK30|CHANGE IN THE INSULIN PUMP CASE ASSEMBLY MANUFACTURING PROCESS AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC) TO RECEIVE PUMP CASES DIRECTLY FROM A SUPPLIER WITH A NEW KEYPAD AND OVERLAY. THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM.
P100026|S010|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2014|02/25/2014|||OK30|ADD A SECOND SUPPLIER FOR THE PRINTED CIRCUIT ASSEMBLY.
P120010|S009|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2014|02/27/2014|||OK30|CHANGE IN THE INSULIN PUMP CASE ASSEMBLY MANUFACTURING PROCESS AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC) TO RECEIVE PUMP CASES DIRECTLY FROM A SUPPLIER WITH A NEW KEYPAD AND OVERLAY. THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM.
P910073|S123|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE IS-1/DF-1 LEAD FAMILY,RELIANCE 4-SITE LEAD FAMILY|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2014|04/24/2014|||APPR|APPROVAL FOR A NEW OUTER SALES BOX AND CLOSURE LABELS FOR THE LEADS.
P960006|S041|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2014|04/24/2014|||APPR|APPROVAL FOR A NEW OUTER SALES BOX AND CLOSURE LABELS FOR THE LEADS.
P050046|S023|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2014|04/24/2014|||APPR|APPROVAL FOR A NEW OUTER SALES BOX AND CLOSURE LABELS FOR THE LEADS.
P100018|S010|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2014|02/27/2014|||OK30|STERILIZATION PROCESS CHANGE.
P010012|S345|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY SPIRAL, EASYTRAK 2, EASYTRAK 3|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2014|04/24/2014|||APPR|APPROVAL FOR A NEW OUTER SALES BOX AND CLOSURE LABELS FOR THE LEADS.
P860004|S202|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/2014|02/25/2014|||APPR|APPROVAL FOR DEVICE REFILL KIT MODEL 8551TO REORDER THE WARNINGS AND PRECAUTIONS ACCORDING TO MEDICAL IMPORTANCE, TO REMOVE INFORMATION FOUND IN THE PREVIOUSLY APPROVED INSTRUCTIONS FOR USE THAT IS NOT APPLICABLE TO MODEL 8551, AND TO ALIGN VERBIAGE WITH THE UPDATED MODEL 856X REFILL KIT INSTRUCTIONS FOR USE.
P110014|S002|DUNE MEDICAL DEVICES INC|111 SPEEN ST SUITE 101||FRAMINGHAM|MA|01701||Diagnostic low electric field|MARGINPROBE SYSTEM|OEE|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2014|05/15/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDIMOR LTD., IN TIBERIAS, ISRAEL (CONTRACT MANUFACTURER).
P860057|S118|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|08/04/2014|||APPR|APPROVAL FOR A CHANGE IN THE SANITATION FREQUENCY OF THE PROCESS WATER SYSTEM USED AT ONE OF THE MANUFACTURING FACILITIES.
P030036|S070|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD FAMILY|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P110010|S069|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P110010|S070|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|UPDATES TO THE SOFTWARE AND HARDWARE OF THE BALLOON MOLDING TOWERS.
P890003|S302|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P900061|S127|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P920015|S129|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P090013|S129|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P830061|S107|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P850089|S106|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P020050|S016|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/20/2014|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P030008|S014|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/20/2014|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P010031|S422|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTA II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA/PROTECTA XT CRT-D S/VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|AUTOMATED EQUIPMENT FOR THE VACUUM/BACKFILL AND LASER SEAM WELD PROCESS.
P090013|S130|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|AUTOMATED EQUIPMENT FOR THE VACUUM/BACKFILL AND LASER SEAM WELD PROCESS.
P980016|S460|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR/VR, EVERA XT DR/VR ICD'S; MAXIMO II ICD; PRTOECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|AUTOMATED EQUIPMENT FOR THE VACUUM/BACKFILL AND LASER SEAM WELD PROCESS.
P980035|S365|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERA, SENSIA IPG'S; ADVISA DR/DR MRI IPG'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|AUTOMATED EQUIPMENT FOR THE VACUUM/BACKFILL AND LASER SEAM WELD PROCESS.
P930039|S104|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD; CAPSUREFIX NOVIS LEAD, SUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P950024|S058|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|REDUCTION IN FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFIC MANUFACTURING AREAS.
P950029|S087|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|CHANGES ON THE SMD ELECTRONIC ASSEMBLY LINE FOR ADDITIONAL COOLING EQUIPMENT.
P980049|S091|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|CHANGES ON THE SMD ELECTRONIC ASSEMBLY LINE FOR ADDITIONAL COOLING EQUIPMENT.
P060027|S058|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750; PARADYM RF CRT-D9750|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|CHANGES ON THE SMD ELECTRONIC ASSEMBLY LINE FOR ADDITIONAL COOLING EQUIPMENT.
P980049|S092|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750,PARADYM DR8750,PARADYM RF CRT-D9750|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|CHANGE RELATED TO THE LASER WELDING PROCESS REWORK FOR A VISUAL DEFECT APPLICABLE TO THESE IMPLANTABLE PULSE GENERATORS.
P060027|S059|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750,PARADYM RF CRT-D9750|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2014|02/27/2014|||OK30|CHANGE RELATED TO THE LASER WELDING PROCESS REWORK FOR A VISUAL DEFECT APPLICABLE TO THESE IMPLANTABLE PULSE GENERATORS.
P110010|S071|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|REDUCTION IN INSPECTION WAIT TIME FOR A MOLDED MANIFOLD COMPONENT.
P110019|S062|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|01/30/2014|09/04/2014|||APPR|APPROVAL FOR THE POST APPROVAL STUDY LABELING UPDATES FOR THE CLINICAL STUDIES FOLLOWED UNDER THIS PMA FOR THE XIENCE PRIME AND XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENTS.
P020002|S007|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP IMAGING SYSTEM|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/30/2014|04/29/2014|||APPR|APPROVAL FOR THE INTRODUCTION OF THE THINPREP® IMAGER DUO IMAGING STATION, HARDWARE (CAMERA AND EXTERIOR HOUSING) CHANGES, AND ASSOCIATED SOFTWARE CHANGES.
P980035|S366|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG'S; ADVISA DR/DR MRI IPG'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|NEW CURE AND PRE-HEAT OVEN FOR THE MEDICAL ADHESIVE CURING PROCESS FOR THE DEVICES.
P010031|S423|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D VIVA S CRT-D, VIVA XT CRT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|NEW CURE AND PRE-HEAT OVEN FOR THE MEDICAL ADHESIVE CURING PROCESS FOR THE DEVICES.
P090013|S131|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|NEW CURE AND PRE-HEAT OVEN FOR THE MEDICAL ADHESIVE CURING PROCESS FOR THE DEVICES.
P980016|S461|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR/S VR ICD'S, EVERA XT DR/VR ICD'S, MAXIMO II ICD, PROTECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR IC|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|NEW CURE AND PRE-HEAT OVEN FOR THE MEDICAL ADHESIVE CURING PROCESS FOR THE DEVICES.
P110010|S072|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEM|NIQ|CV|30-Day Notice||N|01/30/2014|02/27/2014|||OK30|USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE RECEIVING INSPECTION AREA.
P110040|S004|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/28/2014|||OK30|MULTIPLE CHANGES IN THE STENT PROCESSING.
N970003|S158|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|FORMIO, VITALIO, ADVANTIO, INGENIO-- PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|ADD INSPECTION CRITERIA AT THE SPOT-WELDING STEP BEFORE SPOT-WELDING THE FEEDTHRU WIRES TO THE CONNECTOR BLOCKS.
P010031|S424|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|ADD AN ADDITIONAL INCOMING INSPECTION TEST OF THE RAW MATERIAL USED TO MANUFACTURE THE CAPACITOR FEED THROUGH DEFORMATION ELEMENTS FOR THE DEVICES.
P030005|S105|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) INVIVE AND INTUA MODELS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|ADD INSPECTION CRITERIA AT THE SPOT-WELDING STEP BEFORE SPOT-WELDING THE FEEDTHRU WIRES TO THE CONNECTOR BLOCKS.
P980016|S462|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2014|02/27/2014|||OK30|ADD AN ADDITIONAL INCOMING INSPECTION TEST OF THE RAW MATERIAL USED TO MANUFACTURE THE CAPACITOR FEED THROUGH DEFORMATION ELEMENTS FOR THE DEVICES.
P120006|S010|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/31/2014|09/30/2014|||APPR|APPROVAL FOR CHANGES TO THE CUSTOMSEAL KIT TO ACHIEVE A SHORTER CURE TIME OF THE FILL POLYMER.
P110010|S073|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PHATINUM CHROMIUM CORONARY STENT SYSTEM-  (MES)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|02/27/2014|||OK30|SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
P110010|S074|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PRMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (CMS)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|02/27/2014|||OK30|CHANGE TO THE STERILIZATION FACILITY¿S CENTRAL MONITORING SYSTEM (CMS).
P990023|S012|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (QVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|02/27/2014|||OK30|USE OF A NEW METHOD FOR THE IDENTIFICATION AND DETERMINATION OF HYDROXYPROPYLMETHYLCELLULOSE (HPMC) IN THE CELLUGEL OVD.
P110019|S063|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|07/03/2014|||APPR|APPROVAL TO REMOVE A STENT INSPECTION STEP.
P990027|S019|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217A EXCIMER LASER AND TEHNOLAS 217Z ZYOPTIX SYSTEMS|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|02/27/2014|||OK30|REPLACEMENT OF THE CAPACITOR AND DIAGNOSTIC MONITOR.
P100040|S016|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|02/26/2014|||OK30|DUPLICATE THE STENT GRAFT WASHING PROCESS AND THE INTERIM PACKAGING/ SHIPMENT OF STENT GRAFTS FROM ONE APPROVED STENT GRAFT MANUFACTURING SITE TO ANOTHER.
P070027|S038|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|02/26/2014|||OK30|DUPLICATE THE STENT GRAFT WASHING PROCESS AND THE INTERIM PACKAGING/ SHIPMENT OF STENT GRAFTS FROM ONE APPROVED STENT GRAFT MANUFACTURING SITE TO ANOTHER.
P100021|S033|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|02/26/2014|||OK30|DUPLICATE THE STENT GRAFT WASHING PROCESS AND THE INTERIM PACKAGING/ SHIPMENT OF STENT GRAFTS FROM ONE APPROVED STENT GRAFT MANUFACTURING SITE TO ANOTHER.
P010015|S233|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/31/2014|02/27/2014|||OK30|MODIFYING THE START AND END POSITION OF THE WELD SEQUENCE, CORRECTING A SYNCHRONIZATION ISSUE IN THE EQUIPMENT PROGRAM, AND MODIFYING THE ASSOCIATED WORK INSTRUCTIONS FOR THE MIDDLE BRACKET USED WITH THE DEVICES.
P100041|S048|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2014|03/10/2014|||OK30|CHANGE TO THE MANUFACTURING PROCESS OF THE CRIMPER COMPONENT FOR THE 26 MM DEVICE SIZE.
P110021|S035|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2014|03/10/2014|||OK30|CHANGE TO THE MANUFACTURING PROCESS OF THE CRIMPER COMPONENT FOR THE 26 MM DEVICE SIZE.
P060030|S039|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2014|03/04/2014|||OK30|UPDATE OF THE CALIBRATION TEST DEFINITION FILE (TDF) USED IN THE PRODUCTION OF THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST VERSION 2.0 FOR USE WITH THE HIGH PURE SYSTEM.
P110023|S006|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/03/2014|06/22/2014|||APPR|APPROVAL FOR UPDATED LABELING THAT INCLUDES 3-YEAR CLINICAL OUTCOMES.
P080011|S029|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|02/03/2014|06/03/2014|||APPR|APPROVAL FOR NEW BRAND NAMES BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL.
P040008|S008|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA (TPSA) ASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2014|03/06/2014|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR THE CRITICAL COMPONENT: 4 AND 8 ML CAPACITY GLASS VIALS.
P980037|S041|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2014|03/05/2014|||OK30|MODIFICATION TO CHANGE THE CURRENT MANUAL METHOD OF QUANTIFYING THE AMOUNT OF BACTERIAL ENDOTOXINS PRESENT TO USING AN AUTOMATED INSTRUMENT. ADDITIONALLY, THE NUMBER OF SAMPLES COLLECTED WILL BE CHANGED TO THREE SAMPLES PER STERILE LOAD, TESTED ON A POOLED BASIS AND WITH EXPLICIT EXTRACTION INSTRUCTIONS.
P900056|S132|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (ROTABLATOR CONSOLE AND FOOT PEDAL)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/03/2014|08/01/2014|||APPR|APPROVAL FOR COMPONENT AND MANUFACTURING PROCESS CHANGES TO THE ROTABLATOR CONSOLE AND DYNAGLIDE FOOT PEDAL.
P110013|S034|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORNARY STENT SYSTEM|NIQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2014|03/04/2014|||APPR|APPROVAL FOR A RECONCILIATION PROCESS FOR COMPLIANCE CHART LABELS.
P060033|S088|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2014|03/04/2014|||APPR|APPROVAL FOR A RECONCILIATION PROCESS FOR COMPLIANCE CHART LABELS.
P030009|S074|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT STYSTEMS|MAF|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2014|03/04/2014|||APPR|APPROVAL FOR A RECONCILIATION PROCESS FOR COMPLIANCE CHART LABELS.
P840001|S260|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS IMPLANTABLE ITREL, RESORE AND SYNERGY FAMILIES,|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2014|06/04/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A NEW OVEN FOR CURING MEDICAL ADHESIVE.
P960009|S188|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA, KINETRA AND SOLETRA FAMILIES|MHY|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2014|06/04/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A NEW OVEN FOR CURING MEDICAL ADHESIVE.
P970004|S167|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2014|06/04/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A NEW OVEN FOR CURING MEDICAL ADHESIVE.
P080025|S063|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2014|06/04/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF A NEW OVEN FOR CURING MEDICAL ADHESIVE.
P910023|S329|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FORTIFY, FORTIFY ASSURA AND ELLIPSE ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2014|03/04/2014|||OK30|IMPLEMENT CHANGES TO THE PARYLENE REMOVAL PROCESS USED DURING ICD AND CRT-D MANUFACTURE.
P030054|S260|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY, UNIFY ASSURA, UNIFY QUADRA AND QUADRA ASSURA CRT-D'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2014|03/04/2014|||OK30|IMPLEMENT CHANGES TO THE PARYLENE REMOVAL PROCESS USED DURING ICD AND CRT-D MANUFACTURE.
P880086|S239|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|IDENTITY, SUSTAINXL, VERITY VICTORY ZEPHYR, ACCENT FAMILIES OF PACEMAKER DEVICE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2014|03/04/2014|||OK30|CHANGE IN THE WIRE BOND PROCESS VERIFICATION FREQUENCY UTILIZED FOR THE HYBRID ASSEMBLIES OF THE DEVICES.
P030035|S117|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM FAMILY OF CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2014|03/04/2014|||OK30|CHANGE IN THE WIRE BOND PROCESS VERIFICATION FREQUENCY UTILIZED FOR THE HYBRID ASSEMBLIES OF THE DEVICES.
P910023|S330|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT , ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2014|03/04/2014|||OK30|CHANGE IN THE WIRE BOND PROCESS VERIFICATION FREQUENCY UTILIZED FOR THE HYBRID ASSEMBLIES OF THE DEVICES.
P030054|S261|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2014|03/04/2014|||OK30|CHANGE IN THE WIRE BOND PROCESS VERIFICATION FREQUENCY UTILIZED FOR THE HYBRID ASSEMBLIES OF THE DEVICES.
P120010|S010|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMPS; ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2014|03/06/2014|||OK30|ADDITION OF AN ALTERNATE WAREHOUSE FACILITY FOR THE HANDLING OF RAW MATERIALS INCLUDING SUBASSEMBLIES AND COMPONENTS FOR THE MINIMED 530G INSULIN PUMP (MMT-551, MMT-751). THE MINIMED 530G INSULIN PUMP IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P010013|S052|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2014|02/25/2014|||OK30|SOFTWARE MODIFICATIONS FOR DISTRIBUTION CONTROL SORTER TOOL (DCST) SYSTEM FOR THE DEVICES.
P990081|S028|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2014|05/06/2014|||APPR|APPROVAL FOR A NEW ADHESIVE FOR THE SLIDE HEATERS ON THE BENCHMARK XT AND ULTRA AUTOMATED SLIDE STAINERS.
P020055|S014|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2014|05/06/2014|||APPR|APPROVAL FOR A NEW ADHESIVE FOR THE SLIDE HEATERS ON THE BENCHMARK XT AND ULTRA AUTOMATED SLIDE STAINERS.
P100027|S017|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2014|05/06/2014|||APPR|APPROVAL FOR A NEW ADHESIVE FOR THE SLIDE HEATERS ON THE BENCHMARK XT AND ULTRA AUTOMATED SLIDE STAINERS.
P130004|S001|OCULAR THERAPEUTICS, INC.|36 CROSBY DR SUITE 101||BEDFORD|MA|01730||Ophthalmic Sealant|RESURE SEALANT|PFZ|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/07/2014|10/02/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P790002|S031|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET EBI BONE HEALING|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|02/07/2014|04/30/2014|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE SOFTWARE TO PREVENT A CANNOT TREAT ERROR.
P130004|S002|OCULAR THERAPEUTICS, INC.|36 CROSBY DR SUITE 101||BEDFORD|MA|01730||Ophthalmic Sealant|RESURE SEALANT|PFZ|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/07/2014|07/21/2016|||APPR|Approval for the ReSure® Sealant Device Exposure Registry post-approval study protocol.
P030017|S190|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/07/2014|03/07/2014|||OK30|UPDATE TO TEST SOFTWARE.
P100040|S017|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM|MIH|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/07/2014|04/30/2014|||APPR|APPROVAL FOR THE ADDITION OF THE FREEFLO TAPARED STENT-GRAFTS TO THE LIST OF DEVICES INDICATED FOR TREATING THORACIC AORTIC DISSECTIONS,
P060039|S056|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN STARFIX MODEL 4195 LEADS|OJX|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/07/2014|08/04/2014|||APPR|APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO INCLUDE THE POST-APPROVAL STUDY RESULTS FOR THE DESTINATION THERAPY INDICATION AND TO ADD A DISCUSSION ON PUMP THROMBOSIS.
P970053|S013|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EXCIMER LASER SYSTEM EC-5000|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2014|11/21/2014|||APPR|APPROVAL TO USE THE OPD-SCAN III ABERROMETER AND UPDATE THE FINAL FIT SOFTWARE (V1.11 TO 1.12) TO FACILITATE COMPATIBILITY WITH A NEW ABERROMETER TO PERFORM TOPOGRAPHY-GUIDED LASER IN-SITU KERATOMILEUSIS (LASIK).
P860003|S075|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS KIT|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|02/10/2014|05/09/2014|||APPR|APPROVAL FOR A CHANGE IN THE GEOMETRY OF THE STAND-OFFS FEATURED ON THE INNER LOWER BOWL COVER OF THE CELLEX® PROCEDURAL KIT¿S CENTRIFUGE BOWL
P070015|S120|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2014|03/10/2014|||OK30|MODIFICATIONS TO THE SAMPLING PLAN FOR THE XIENCE FINAL PACKAGING OXYGEN CONTENT TESTING.
P110019|S064|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2014|03/10/2014|||OK30|MODIFICATIONS TO THE SAMPLING PLAN FOR THE XIENCE FINAL PACKAGING OXYGEN CONTENT TESTING.
P060040|S031|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS)|DSQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/10/2014|08/05/2014|||APPR|APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO INCLUDE THE POST-APPROVAL STUDY RESULTS FOR THE DESTINATION THERAPY INDICATION AND TO ADD A DISCUSSION ON PUMP THROMBOSIS.
P100047|S037|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2014|03/13/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE SUPPLIER FOR THE NON-PATIENT CONTACTING PATCH MATERIAL USED IN THE HEARTWARE® VENTRICULAR ASSIST SYSTEM.
P110010|S075|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS / PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2014|03/13/2014|||OK30|CANGES TO THE PROCESSING CONTROLS FOR PACKAGING AND LABELING FOR THE PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING CORONARY STENT SYSTEMS.
P100047|S038|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HVAD SEWING RING-HEARTWARE VENTRICULAR ASSIST SYTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2014|03/13/2014|||OK30|IMPLEMENTATION OF A TOOL TO BE USED AS PART OF PROCESS MONITORING DURING THE MANUFACTURING OF THE HVAD® SEWING RING.
P050038|S020|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2014|03/12/2014|||OK30|PROPOSED TRANSFER OF THE DISTRIBUTION, WAREHOUSE FACILITY AND CUSTOMER SERVICE ORDERING FOR FINISHED DEVICES.
P040034|S023|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2014|03/11/2014|||OK30|ADDITION OF A NEW MATERIAL SUPPLIER.
P930029|S041|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONDUCTR MC,RF CONTACTR,RF ENHANCR II,RF MARINR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2014|03/13/2014|||OK30|USE OF THE INCOMING INSPECTION (RECEIVING BATCH ON PURCHASE ORDER) WORK FLOW WITH SAP QUALITY MANAGEMENT (QM) MODULE.
P840001|S261|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC SPINAL CORD STIMULATION SYSTEMS|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/2014|03/13/2014|||APPR|APPROVAL FOR CHANGES BEING EFFECTED TO THE LABELING OF MEDTRONIC SPINAL CORD STIMULATION SYSTEMS. SPECIFICALLY, A POSSIBLE ADVERSE EVENT DELAYED SPINAL CORD COMPRESSION DUE TO EPIDURAL MASS FORMATION IS BEING ADDED TO THE LABELING
P020018|S050|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/11/2014|04/02/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P950029|S088|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable pulse generator, pacemaker (non-CRT)|REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2014|04/09/2014|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES.
P100026|S011|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2014|05/07/2014|||APPR|APPROVAL FOR THE ADDITION OF ETHERNET CONNECTIVITY TO ACCESS THE PATIENT DATA MANAGEMENT SYSTEM DATABASE.
P100047|S039|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2014|03/14/2014|||OK30|SOFTWARE CHANGES TO THE EQUIPMENT USED FOR THE SURFACE TEXTURE AND FORM MEASUREMENTS OF COMPONENTS OF THE HEARTWARE VENTRICULAR ASSIST DEVICE PUMP.
P090012|S003|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/12/2014|10/22/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100023|S088|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2014|03/14/2014|||OK30|ALTERNATE PROCESSES AND EQUIPMENT FOR THE MANUFACTURING AND INSPECTION OF THE DISTAL TIP OF THE DELIVERY SYSTEMS.
P110010|S076|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS / PROMUS PREMIER  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2014|03/14/2014|||OK30|ALTERNATE PROCESSES AND EQUIPMENT FOR THE MANUFACTURING AND INSPECTION OF THE DISTAL TIP OF THE DELIVERY SYSTEMS.
P110013|S035|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2014|03/14/2014|||OK30|AUTOMATING THE PARTS OF THE STENT COATING WEIGHT PROCESSES.
P980049|S093|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable cardioverter defibrillator (non-CRT)|PARADYM VR 8750, PARADYM DR 8750, PARADYM RF CRT-D|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2014|04/09/2014|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES.
P060027|S060|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF CRT-D9750|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/12/2014|04/09/2014|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES.
P990081|S029|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|Normal 180 Day Track|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2014|08/06/2014|||APPR|APPROVAL FOR ADDITION OF THE FACILITY AT ROCHE IN PENZBERG, GERMANY FOR MANUFACTURING THE RAW MATERIAL (ANTIBODY) FOR THE PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY EMPLOYING A DIFFERENT CELL CULTURE MEDIA.
P910023|S331|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2014|06/20/2014|||APPR|APPROVAL FOR A CHANGE TO THE INTEGRATED CIRCUIT USED IN THE MANUFACTURING OF THE ICDS AND CRT-DS.
P030054|S262|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/28/2014|06/20/2014|||APPR|APPROVAL FOR A CHANGE TO THE INTEGRATED CIRCUIT USED IN THE MANUFACTURING OF THE ICDS AND CRT-DS.
P000006|S036|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2014|08/25/2014|||APPR|APPROVAL FOR TO USE A NEW VENDOR/ ADDITIONAL SUPPLIER AND A NEW MOLD.
P060002|S034|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|FLAIR ENDOVASCULAR STENT GRAFT|PFV|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/14/2014|08/13/2014|||APPR|APPROVAL FOR UPDATED INSTRUCTIONS FOR USE (IFU) TO INCLUDE DATA FROM THE POSTAPPROVAL STUDY (RENOVA).
P000014|S027|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2014|03/10/2014|||OK30|ADDITION OF NEGATIVE SAMPLES IN THE FINAL RELEASE QC TEST, AND AN ADDITION OF THE RAW MATERIAL COMBINATION TEST IN THE MANUFACTURE OF THE CONJUGATE REAGENT.
P010031|S425|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2014|03/20/2014|||APPR|APPROVAL FOR A MINOR MATERIAL CHANGE FOR THE CAPACITOR ELECTRICALFEEDTHROUGH.
P980016|S463|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2014|03/20/2014|||APPR|APPROVAL FOR A MINOR MATERIAL CHANGE FOR THE CAPACITOR ELECTRICALFEEDTHROUGH.
P960058|S108|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/14/2014|07/29/2014|||APPR|APPROVAL FOR THE CONCAVE UNIVERSAL HEAD PIECE, A REDESIGNED VERSION OF THE CURRENT UNIVERSAL HEAD PIECE. THE CONCAVE UNIVERSAL HEAD PIECE SUPPORTS BOTH BEHIND THE EARAND BODY WORN SOUND PROCESSORS AND IS INTENDED FOR INCREASE OF WEARING COMFORT FOR THE HIRES90K ADVANTAGE IMPLANT USERS.
P980016|S464|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2014|03/04/2014|||OK30|REPLACEMENT OF TWO (2) PICK AND PLACE MACHINES WITH ONE (1) NEW SYSTEM USED IN HYBRID MANUFACTURING FOR THE IDENTIFIED DEVICES.
P960040|S309|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2014|03/12/2014|||OK30|ALTERNATE SUPPLIER FOR THE CAN CAPACITOR COMPONENT.
P010031|S426|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2014|03/04/2014|||OK30|REPLACEMENT OF TWO (2) PICK AND PLACE MACHINES WITH ONE (1) NEW SYSTEM USED IN HYBRID MANUFACTURING FOR THE IDENTIFIED DEVICES.
P010012|S346|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/14/2014|03/12/2014|||OK30|ALTERNATE SUPPLIER FOR THE CAN CAPACITOR COMPONENT.
P110004|S002|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/14/2014|05/01/2014|||APPR|APPROVAL FOR A MODIFICATION TO THE D-CATHETER TIP SPRING.
P000037|S035|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/18/2014|||OK30|CHANGE FROM MANUAL ETCHING TO AUTOMATED COMPUTER-CONTROLLED LASER ETCHING OF SERIAL NUMBERS ON COMPONENTS.
P060037|S030|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE|NJL|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/18/2014|08/14/2014|||APPR|APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
P010031|S427|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/07/2014|||OK30|CHANGE IN THE PROCESSING AID USED IN POLYTETRAFLUORO-ETHYLENE (PTFE) PRODUCTION AT A SUPPLIER.
P980016|S465|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/07/2014|||OK30|CHANGE IN THE PROCESSING AID USED IN POLYTETRAFLUORO-ETHYLENE (PTFE) PRODUCTION AT A SUPPLIER.
P980016|S466|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ID, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/05/2014|||OK30|CHANGE IN THE CRIMPING PROCESS FOR THE FEED THROUGH ASSEMBLY USED IN THE MANUFACTURE OF SELECTED IMPLANTABLE CARDIAC DEFIBRILLATORS (ICD) AND CARDIOVERTER RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (CRT-D).
P010031|S428|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/05/2014|||OK30|CHANGE IN THE CRIMPING PROCESS FOR THE FEED THROUGH ASSEMBLY USED IN THE MANUFACTURE OF SELECTED IMPLANTABLE CARDIAC DEFIBRILLATORS (ICD) AND CARDIOVERTER RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (CRT-D).
P120010|S011|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/20/2014|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) TO ADD A NEW SENSOR FABRICATION CONFIGURATION TO INCLUDE A 48-UP SENSOR MASK WHICH WILL BE MANUFACTURED BY A NEW VENDOR. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P050028|S040|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COMBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/18/2014|||OK30|CHANGE TO ADD A NEW SUPPLIER FOR AN OPTIONAL INSTRUMENTATION COMPONENT OF THE COBAS® AMPLIPREP/ COBAS® TAQMAN® SYSTEM.
P060030|S040|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/18/2014|||OK30|CHANGE TO ADD A NEW SUPPLIER FOR AN OPTIONAL INSTRUMENTATION COMPONENT OF THE COBAS® AMPLIPREP/ COBAS® TAQMAN® SYSTEM.
P110037|S013|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/18/2014|||OK30|CHANGE TO ADD A NEW SUPPLIER FOR AN OPTIONAL INSTRUMENTATION COMPONENT OF THE COBAS® AMPLIPREP/ COBAS® TAQMAN® SYSTEM.
P060033|S089|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/19/2014|||OK30|CHANGES TO HOW EXTRUDED COMPONENTS ARE PHYSICALLY GROUPED AND TO THE WAY SAMPLES ARE SELECTED FOR IN-PROCESS TESTING.
P030009|S075|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/19/2014|||OK30|CHANGES TO HOW EXTRUDED COMPONENTS ARE PHYSICALLY GROUPED AND TO THE WAY SAMPLES ARE SELECTED FOR IN-PROCESS TESTING.
P110013|S036|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/19/2014|||OK30|CHANGES TO HOW EXTRUDED COMPONENTS ARE PHYSICALLY GROUPED AND TO THE WAY SAMPLES ARE SELECTED FOR IN-PROCESS TESTING.
P840001|S262|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREPRIME NEUROSTIMULATOR,PRIMEADVANCED NEUROSTIMULATOR,ITREL 4 NEUROSTIMULATOR,PRIMEADVANCED SURESCAN MRI NEUROSTIMU|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/19/2014|||OK30|CHANGES TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P960009|S189|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC NEUROSTIMULATOR,ACTIVA SCNEUROSTIMULATOR,ACTIVA SC NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/19/2014|||OK30|CHANGES TO THE BATTERY BURN-IN PROCESS AND INSPECTION METHODS.
P910023|S332|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/06/2014|||OK30|ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE HYBRID ASSEMBLIES.
P030054|S263|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUADRA, PROMOTE+, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUANDRA FAMILIES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/06/2014|||OK30|ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE HYBRID ASSEMBLIES.
P010031|S429|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/12/2014|||OK30|ADDITION OF AN INSPECTION TO THE CRIMP HEIGHT OF THE FEEDTHROUGH PIN FOR THE DEVICES.
P060040|S032|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/18/2014|||OK30|REDUCTION IN POST-STERILIZATION HEATED AERATION TIME FOR SOME COMPONENTS.
P980016|S467|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/12/2014|||OK30|ADDITION OF AN INSPECTION TO THE CRIMP HEIGHT OF THE FEEDTHROUGH PIN FOR THE DEVICES.
P960043|S087|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE, PROCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2014|03/20/2014|||OK30|ALTERNATE SUPPLIER FOR THE EPTFE FIBER USED IN ONE OF THE COMPONENTS AND MINOR ASSOCIATED MANUFACTURING CHANGES.
P050038|S021|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2014|03/19/2014|||OK30|ADDITIONAL POUCH SEALER AND AN ALTERNATE PACKAGING SEAL STRENGTH TEST METHOD.
P030053|S017|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL BREAST IMPLANT|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/19/2014|04/18/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110008|S003|PARADIGM SPINE, LLC|505 PARK AVENUE, 14TH  FLOOR||NEW YORK|NY|10022||Prosthesis, spinous process spacer/plate|COFLEX INTERLAMINAR TECHNOLOGY|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/19/2014|08/05/2015|||APPR|APPROVAL OF THE  POST-APPROVAL STUDY PROTOCOL.
P870072|S059|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2014|03/18/2014|||OK30|REDUCTION IN POST-STERILIZATION HEATED AERATION TIME FOR SOME COMPONENTS.
P130006|S001|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND GORE BIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2014|04/10/2014|||APPR|APPROVAL FOR REVISED SPECIFICATION LIMITS FOR MANUFACTURING AIDS.
P120010|S012|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2014|03/21/2014|||OK30|NEW LASER TECHNOLOGY SYSTEM TO CUT A RECTANGULAR WINDOW IN THE SENSOR TUBE FOR THE ENLITE SENSOR (MMT-7008A, MMT-7008B). THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P130006|S002|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2014|04/10/2014|||APPR|APPROVAL FOR ADDING RADIOPAQUE MARKERS TO THE ENDOPROSTHESIS.
P010029|S019|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2014|03/26/2014|||OK30|INTRODUCTION OF A NEW THERMOFORMING MACHINE FOR SECONDARY PACKAGING.
P000025|S076|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2014|03/26/2014|||OK30|ALTERNATE COMPONENT SUPPLIER.
P020009|S117|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/19/2014|||OK30|ELIMINATE THE POUCH SEAL PULL TEST INSPECTION IN THE MANUAL FINAL PACKAGING OPERATION.
P050037|S047|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/13/2014|||OK30|IMPLEMENTATION OF IN-HOUSE BIOBURDEN TESTING OF THE RADIESSE PRODUCT.
P050052|S051|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/13/2014|||OK30|IMPLEMENTATION OF IN-HOUSE BIOBURDEN TESTING OF THE RADIESSE PRODUCT.
P040016|S123|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/19/2014|||OK30|ELIMINATE THE POUCH SEAL PULL TEST INSPECTION IN THE MANUAL FINAL PACKAGING OPERATION.
P060006|S055|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/19/2014|||OK30|ELIMINATE THE POUCH SEAL PULL TEST INSPECTION IN THE MANUAL FINAL PACKAGING OPERATION.
N970003|S159|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSAR, PULSAR MAX, DISCOVER, INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO FAMILIES OF PACEMAKER|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2014|05/02/2014|||APPR|APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
P940031|S076|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR, MERIDIAN, DISCOVER FAMILIES OF PACEMAKER|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2014|05/02/2014|||APPR|APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
P030005|S106|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK  RENEWAL TR, INVIVE, INTUA FAMILIES OF CRT-PS|NKE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2014|05/02/2014|||APPR|APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
P910077|S141|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX, VENTAK MINI FAMILIES OF ICDS|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2014|05/02/2014|||APPR|APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
P110042|S027|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/12/2014|||OK30|ADD A FIELD EFFECT TRANSISTOR SATURATION TEST AT THE SUPPLIER.
P100026|S013|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/21/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE CORTICAL STRIP LEAD ASSEMBLY.
P950029|S089|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/20/2014|||OK30|CHANGE IN THE GLUING PROCESS FOR THE SETSCREW CAPS, X-RAY TAG AND CONNECTION BLOCK CAVITIES.
P930038|S072|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|03/21/2014|||OK30|ALTERNATIVE TO BATCH TESTING FOR BACTERIAL ENDOTOXIN TESTING (BET).
P010055|S009|PROSTALUND AB|SCHEELEVAGEN 17||SE-223 63 LUND||SE-22|223|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROSTALUND CORETHERM SYSTEM AND PROSTALAND CORETHERM ACCESSORIES|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/21/2014|07/30/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORIFICE MEDICAL AB IN YSTAD, SWEDEN.
P960040|S310|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV, VENTAK PRIZM, VITALITY, CONFIENT, TELIGEN, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF ICDS|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2014|05/02/2014|||APPR|APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
P010012|S347|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF CRT-DS|LWP|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2014|05/02/2014|||APPR|APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
P910073|S124|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2014|05/02/2014|||APPR|APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
P830060|S077|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AID-B/BR AND VENTAK ICD|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/21/2014|05/02/2014|||APPR|APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
P120006|S011|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRIVASCULAR,INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/20/2014|||OK30|EXTENSION OF THE HOLD TIME OF STRETCHED FILM IN THE MANUFACTURE OF THERETAINING WRAP.
P900056|S133|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P920047|S066|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P980003|S047|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P020009|S118|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P020025|S054|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P040016|S124|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P060006|S056|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P100023|S089|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL -ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P070027|S039|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/24/2014|07/16/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P120010|S013|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|NEW LASER CUTTING PROGRAM ON THE EXISTING LASER THAT IS USED DURING THE SENSOR FABRICATION PROCESS.
P850022|S021|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|ALTERNATE-SECONDARY SUPPLIER.
P060038|S019|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/20/2014|||OK30|CHANGE IN THE YARN SUPPLIER.
P110010|S077|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/26/2014|||OK30|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
P030002|S030|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|CRYSTALENS ACCOMMODATING INTRAOCULAR LENS AND TRULIGN TORIC INTRAOCULAR LENS|MJP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2014|03/24/2014|||OK30|ADDITIONAL HAPTIC SUPPLIER BE USED.
P010013|S053|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DEVICE|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2014|03/26/2014|||OK30|CHANGE IN THE MANUFACTURING PROCESS TO ALLOW THE USE OF LEAD-FREE SOLDER IN THE CABLE SUB-ASSEMBLY.
P040047|S034|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2014|03/14/2014|||OK30|IMPLEMENTATION OF IN-HOUSE BIOBURDEN TESTING OF THE COAPTITE PRODUCT.
P090013|S132|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ENRHYTHM MRI EMDRO1; REVO MRI RVDRO1|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/2014|04/24/2014|||APPR|APPROVAL FOR SIX SOFTWARE DEVICE APPLICATIONS ON THE ENCOREPROGRAMMER MODEL 29901.
P980016|S468|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR 7274; MARQUIS VR 7230B/7230X/723E; MAXIMO DR7278; MAXIMO VR 7232|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/2014|04/24/2014|||APPR|APPROVAL FOR SIX SOFTWARE DEVICE APPLICATIONS ON THE ENCOREPROGRAMMER MODEL 29901.
P130004|S004|OCULAR THERAPEUTICS, INC.|36 CROSBY DR SUITE 101||BEDFORD|MA|01730||Ophthalmic Sealant|RESURE SEALANT|PFZ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2014|03/25/2014|||OK30|CHANGE IN THE VOLUME OF DILUENT IN THE DROPPER BOTTLE.
P070014|S042|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2014|03/27/2014|||OK30|ALTERNATE EQUIPMENT AND AUTOMATED PROCESS FOR THE TANTALUM MARKER COINING PROCESS.
P020009|S119|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|02/25/2014|03/25/2014|||OK30|ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.
P040016|S125|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|02/25/2014|03/25/2014|||OK30|ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.
P060006|S057|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice||N|02/25/2014|03/25/2014|||OK30|ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.
P100023|S090|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|02/25/2014|03/25/2014|||OK30|ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.
P860057|S119|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO|DYE|CV|30-Day Notice||N|02/25/2014|03/14/2014|||OK30|CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
P010041|S048|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice||N|02/25/2014|03/14/2014|||OK30|CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
P870056|S065|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice||N|02/25/2014|03/14/2014|||OK30|CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
P870077|S059|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS  WITH EXTENDED SUTURE|DYE|CV|30-Day Notice||N|02/25/2014|03/14/2014|||OK30|CHANGE IN THE POLYESTER CLOTH MANUFACTURING AID.
P070026|S021|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/26/2014|05/19/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970003|S168|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|CYBERONICS VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2014|03/28/2014|||OK30|MAKE CHANGES TO THE DIE PACKAGING USED IN THE CREATION OF THE APPLICATION SPECIFIC INTEGRATED CIRCUIT.
P060034|S008|Bio-Rad Laboratories, Inc.|6565 185TH AVE., N.E.||REDMOND|WA|98052||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|MONOLISA ANTI-HBC IGM EIA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2014|03/19/2014|||OK30|ADDITION OF THE MILLROCK FREEZE DRYER TO THE LIST OF APPROVED EQUIPMENT FOR LYOPHILIZING THE CONJUGATE REAGENT FINAL VIALS.
P040045|S042|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON SENOFILCON A BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2014|03/28/2014|||OK30|IMPLEMENTATION OF CURE PROCESS IMPROVEMENTS.
P100047|S040|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/26/2014|08/25/2014|||APPR|APPROVAL FOR CHANGING THE AC AND DC ADAPTORS OUTPUT CABLING SHEATH AND OVER-MOLD MATERIAL AS WELL AS THE NUMBER OF CONDUCTOR WIRES.
P110006|S003|U-SYSTEMS, INC.|9900 WEST INNOVATIVE DRIVE|MAIL STOP RP2138|WAUWATOSA|WI|53226||Automated breast ultrasound|INVENIA ABUS|PAA|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2014|03/20/2014|||OK30|CHANGES TO INCLUDE UPDATING MANUFACTURING DOCUMENTS, WORK INSTRUCTIONS, AND TEST PROCEDURES.  ALSO, HIGH LEVEL ASSEMBLY OF SOME SUBCOMPONENTS WILL BE PERFORMED BY PLEXUS CORPORATION.
N16837|S012|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/28/2014|||OK30|ALTERNATE SUPPLIER FOR THE BOVINE CAROTID ARTERY.
P820003|S127|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PROXIMAL (D01) CONNECTOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/26/2014|||OK30|CHANGES TO THE PATIENT CABLE PROXIMAL CONNECTOR.
P110003|S004|GENZYME CORP.|500 KENDALL STREET||CAMBRIDGE|MA|02142|1562|Occluder, internal vessel, temporary|LEGOO|OBC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/26/2014|||OK30|IMPLEMENTATION OF A MODIFIED LEGOO FILLING AND INSPECTION PROCESS FOR THE 1.0 ML AND 2.5 ML LEGOO SYRINGES.
P980016|S469|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EGMP5 DOWNLOAD SOFTWARE APPLICATION,EVERA S DR ICD.EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PATIENT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P010041|S049|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/27/2014|||OK30|ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE.
P870056|S066|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PROCINE AORTIC BIOPROSTHESIS ,PROCINE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/27/2014|||OK30|ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE.
P870077|S060|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDEARDS DURAFLEX LOW PRESSURE PROCINE MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/27/2014|||OK30|ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE.
P860057|S120|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS WITH TERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC  BIOP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/27/2014|||OK30|ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE.
P100041|S049|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/27/2014|||OK30|ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE.
P000007|S045|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/27/2014|||OK30|ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE.
P110021|S036|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/27/2014|||OK30|ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE.
P010015|S234|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P080011|S030|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|COOPERVISION COMFILCON A SOFT EXTENDED-WEAR CONTACT LENSES|LPM|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|07/08/2014|||APPR|APPROVAL FOR A NEW MANUFACTURING LINE AT THE PUERTO RICO FACILITY.
P130021|S002|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE SYSTEM|NPT|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|02/27/2014|06/12/2014|14M-0867|07/08/2014|APPR|APPROVAL FOR THE MEDTRONIC COREVALVE SYSTEM. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS (AORTIC VALVE AREA <=1.0 CM2 OR AORTIC VALVE AREA INDEX <=0.6 CM2/M2, A MEAN AORTIC VALVE GRADIENT OF >=40 MM HG, OR A PEAK AORTIC-JET VELOCITY OF >=4.0 M/S) AND WITH NATIVE ANATOMY APPROPRIATE FOR THE 23, 26, 29, OR 31 MM VALVE SYSTEM WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >=8% OR AT A >=15% RISK OF MORTALITY AT 30 DAYS).
P080006|S067|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P990001|S117|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITA ENHANCR II|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P980050|S091|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P090013|S133|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD,REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P980035|S367|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P950024|S059|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P930039|S105|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIC LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FODR 5076 LEAD, VITATRON CRYSTALLINE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P930029|S042|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONTACTR CATHETER, RF ENHANCR II CATHETER, RF MARINR CATHETER, RF CONDUCTR CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P920015|S131|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P900061|S128|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER, CABLE, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, PATIENT MAGNET, UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P890003|S303|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|BATTERY CHECK MONITOR, CAPSURE LEAD, CARELINK PROGRAMMER, CARELINK PROGRAMMER RF HEAD, DESKTOP BOSS SOFTWARE, ECG CABLE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P850089|S107|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P830061|S108|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P820003|S128|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DISPOSABLE EPG COVER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P010031|S430|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XTCRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P030036|S071|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT ; SELECT SECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P060039|S057|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2014|03/12/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
P040003|S014|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE SYSTEM|NRZ|OB|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/26/2014|06/13/2014|||APPR|APPROVAL FOR LABELING UPDATE.
P960016|S045|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2014|04/28/2014|||APPR|APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THEFIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.
P040014|S022|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CATHETER (NON-IRRIGATED)|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2014|04/28/2014|||APPR|APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THE FIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.
P040042|S027|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2014|04/28/2014|||APPR|APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THEFIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.
P060019|S027|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2014|04/28/2014|||APPR|APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THEFIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.
P110016|S011|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|THERAPY COOL PATH DUO CATHETER (12 HOLE IRRIGATED), SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED), COOL PATH DUO ABLATION C|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/03/2014|04/28/2014|||APPR|APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THEFIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.
P000023|S009|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM|LZD|DE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/2014|06/02/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE BONE SCREW LENGTH TO MATCH THELABELED LENGTHS, TO STANDARDIZE THE SCREW THREAD PROFILE AND PITCH, TO INCREASE THE LENGTH OF THE THREADED PORTION OF THE BONE SCREW, TO ROUND THE TIP OF THE SCREW, TO ADD A FILLET BETWEEN THE SCREW HEAD AND SCREW SHAFT, TO STANDARDIZE DIMENSIONS OF CERTAIN GEOMETRICAL FEATURES OF THE BONE SCREWS (THE SCREW HEAD CROWN RADIUS AND DRIVER SLOT DEPTH), TO STANDARDIZE THE MINOR DIAMETER, AND TO INTRODUCE TI-6AL-4V ALLOY BONE SCREWS.
P040021|S025|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR AND EPIC VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/28/2014|04/02/2014|||OK30|CHANGE TO THE INCOMING INSPECTION PLAN FOR THE POLYESTER FABRIC COMPONENT OF THE SUBJECT VALVES.
P090006|S014|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM-ILIAC|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2014|04/03/2014|||OK30|IMPLEMENTATION OF NEW COATING EQUIPMENT AND PROCESS CONTROLS.
P110040|S005|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2014|04/03/2014|||OK30|IMPLEMENTATION OF NEW COATING EQUIPMENT AND PROCESS CONTROLS.
P830060|S078|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/2014|03/31/2014|||APPR|APPROVAL TO ADD STERILIZATION DETAIL INFORMATION AND TO REMOVE THE CIDEX CLEANING STEP FROM THE INSTRUCTIONS FOR USE.
P000035|S009|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM|MPI|DE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/04/2014|06/02/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE BONE SCREW LENGTH TO MATCH THELABELED LENGTHS, TO STANDARDIZE THE SCREW THREAD PROFILE AND PITCH, TO INCREASE THE LENGTH OF THE THREADED PORTION OF THE BONE SCREW, TO ROUND THE TIP OF THE SCREW, TO ADD A FILLET BETWEEN THE SCREW HEAD AND SCREW SHAFT, TO STANDARDIZE DIMENSIONS OF CERTAIN GEOMETRICAL FEATURES OF THE BONE SCREWS (THE SCREW HEAD CROWN RADIUS AND DRIVER SLOT DEPTH), TO STANDARDIZE THE MINOR DIAMETER, AND TO INTRODUCE TI-6AL-4V ALLOY BONE SCREWS.
P100041|S050|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2014|05/19/2014|||APPR|APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
P110021|S037|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2014|05/19/2014|||APPR|APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
P860057|S121|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2014|05/19/2014|||APPR|APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
P840001|S263|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS EXTENSIONS, HINGED 2X4 SURGICAL LEAD, SPECIFY LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2014|04/04/2014|||OK30|RELOCATE THE MANUFACTURING FACILITY OF AN EXTERNAL SUPPLIER.
P010041|S050|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2014|05/19/2014|||APPR|APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
P960009|S190|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS EXTENSIONS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2014|04/04/2014|||OK30|RELOCATE THE MANUFACTURING FACILITY OF AN EXTERNAL SUPPLIER.
P870056|S067|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL  BIOPROTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2014|05/19/2014|||APPR|APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
P870077|S061|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX  LO|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2014|05/19/2014|||APPR|APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
P080027|S016|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/04/2014|07/11/2014|||APPR|APPROVAL FOR A CHANGE TO THE TRANSMITTER THAT COMBINES THECOMPONENTS FROM TWO PRINTED CIRCUIT BOARD ASSEMBLIES (PCBAS) INTO A SINGLE BOARD TRANSMITTER (SBT) WITH ONE PRINTED CIRCUIT BOARD (PCB).
P120010|S014|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2014|04/03/2014|||OK30|CHANGE TO THE DYE LEAK TESTING PROCEDURE, DYE FORMULATION, AND QUALIFICATION OF A NEW MEDICAL TRAY SEALER.
P120010|S015|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR, ENLITE SERTER|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2014|03/31/2014|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) BY ADDING AN ADDITIONAL STEP DURING THE ASSEMBLY PROCEDURE AND AN INSPECTION STEP DURING THE PACKAGING  PROCEDURE. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P920047|S067|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2014|04/04/2014|||OK30|ACCEPTANCE FOR BIOBURDEN TESTING TO BE COMPLETED AT AN ALTERNATE FACILITY
P020025|S055|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP,BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS|OAD|CV|30-Day Notice||N|03/04/2014|04/04/2014|||OK30|ACCEPTANCE FOR BIOBURDEN TESTING TO BE COMPLETED AT AN ALTERNATE FACILITY
P890003|S304|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|REVEAL LINQ SOFTWARE MODEL SWO26|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2014|04/30/2014|||APPR|APPROVAL FOR MODEL SW026 APPLICATION SOFTWARE FOR THE REVEAL LINQ IMPLANTABLE CARDIAC MONITORS USED ON THE MODEL 2090 AND ENCORE PROGRAMMERS.
P100047|S041|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2014|04/04/2014|||OK30|MODIFICATIONS TO THE COATING PROCESS FOR THE DEVICE.
P000007|S046|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/05/2014|05/20/2014|||APPR|APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
P100010|S035|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CRYOABLATION CATHETER; ARCTIC FRONT ADVANCE CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/05/2014|04/03/2014|||OK30|UPDATES TO THE MANUFACTURING STEPS AND FIXTURES AT MANUFACTURING STATION P09 Y BLOCK TO SHAFT ASSEMBLY USED IN THE MANUFACTURE OF THE ARCTIC FRONT AND ARCTIC FRONTADVANCE CATHETERS.
P010032|S077|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|TRIPOLE 16 AND TRIPOLE 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44, LAMITRODE 44C LEADS, LAMITRODE 88 LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2014|04/04/2014|||OK30|ADD A MANUFACTURING SPECIFICATION FOR MINIMUM ELECTRODE WINDOW CUT OUT DIMENSIONS.
P120010|S016|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2014|06/03/2014|||APPR|APPROVAL FOR CHANGES TO THE SOFTWARE TO THE MINIMED 530G INSULIN PUMP (MODELS MMT-551 AND MMT-751). THESE CHANGES INCLUDE CORRECTIONS FOR TWO MOTOR ERROR ANOMALIES AND THREE THRESHOLD SUSPEND ANOMALIES, AND ENHANCEMENTS FOR THE THRESHOLD SUSPEND FEATURE, INSULIN VALUE SETTING, AND MERGED COMMON CODE BASE.
P060040|S033|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LVAS|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/07/2014|04/03/2014|||APPR|APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE AND THE PATIENT HANDBOOK.
P010047|S034|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2014|06/17/2015|||APPR|APPROVAL FOR MODIFYING THE STORAGE CONDITIONS OF PROGEL PLEURAL AIR LEAK. THE INCLUSION OF A CONSECUTIVE OR CUMULATIVE CONTROLLED ROOM TEMPERATURE STORAGE EXCURSION OF 8 °C TO 25 °C FOR A PERIOD UP TO 35 DAYS WITHIN THE APPROVED 24-MONTH SHELF LIFE WHEN THE DEVICE IS NORMALLY STORED BETWEEN 2 °C TO 8°C.
P860047|S028|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|03/28/2014|||OK30|USE OF A NEW POUCH SEALER FOR THE PACKAGING PROCESS OF OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
P090013|S134|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|03/20/2014|||OK30|ADDITIONAL LASER FOR THE ELECTRODE RING TO COIL WELD OPERATION FOR THE DEVICES.
P930039|S106|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|03/20/2014|||OK30|ADDITIONAL LASER FOR THE ELECTRODE RING TO COIL WELD OPERATION FOR THE DEVICES.
P100026|S014|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/04/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR A BATTERY COMPONENT.
P970021|S041|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE UTERINE BALLON THERAPY SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/09/2014|||APPR|APPROVAL FOR THE MANUFACTURING SITE TO BE CHANGED TO CEA MEDICAL MANUFACTURING, INC., IN COLORADO SPRINGS, COLORADO.
P970004|S168|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/02/2014|||OK30|QUALIFICATION OF TWO ALTERNATIVE SUPPLIERS FOR A SILICONE COMPONENT.
P080025|S064|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/02/2014|||OK30|QUALIFICATION OF TWO ALTERNATIVE SUPPLIERS FOR A SILICONE COMPONENT.
P980035|S368|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG, ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/04/2014|||OK30|MANUFACTURING PROCESS CHANGE FOR THE PRINTED WIRING BOARD (PWB) SUBSTRATES AT A MEDTRONIC SECOND TIER SUPPLIER. THESE PWB SUBSTRATES ARE USED IN THE MANUFACTURE OF HYBRID SUBSTRATES AT MEDTRONIC¿S INTERNAL SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), FOR THE DEVICES.
P010015|S235|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/04/2014|||OK30|MANUFACTURING PROCESS CHANGE FOR THE PRINTED WIRING BOARD (PWB) SUBSTRATES AT A MEDTRONIC SECOND TIER SUPPLIER. THESE PWB SUBSTRATES ARE USED IN THE MANUFACTURE OF HYBRID SUBSTRATES AT MEDTRONIC¿S INTERNAL SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), FOR THE DEVICES.
P010031|S431|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/04/2014|||OK30|MANUFACTURING PROCESS CHANGE FOR THE PRINTED WIRING BOARD (PWB) SUBSTRATES AT A MEDTRONIC SECOND TIER SUPPLIER. THESE PWB SUBSTRATES ARE USED IN THE MANUFACTURE OF HYBRID SUBSTRATES AT MEDTRONIC¿S INTERNAL SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), FOR THE DEVICES.
P090013|S135|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/04/2014|||OK30|MANUFACTURING PROCESS CHANGE FOR THE PRINTED WIRING BOARD (PWB) SUBSTRATES AT A MEDTRONIC SECOND TIER SUPPLIER. THESE PWB SUBSTRATES ARE USED IN THE MANUFACTURE OF HYBRID SUBSTRATES AT MEDTRONIC¿S INTERNAL SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), FOR THE DEVICES.
P980016|S470|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2014|04/04/2014|||OK30|MANUFACTURING PROCESS CHANGE FOR THE PRINTED WIRING BOARD (PWB) SUBSTRATES AT A MEDTRONIC SECOND TIER SUPPLIER. THESE PWB SUBSTRATES ARE USED IN THE MANUFACTURE OF HYBRID SUBSTRATES AT MEDTRONIC¿S INTERNAL SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), FOR THE DEVICES.
P050044|S028|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL RT3 DELIVERY SYSTEM|LMF|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/07/2014|06/05/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES TO THE BA-02 DELIVERY SYSTEM COMPONENT OF VITAGEL RT3 SURGICAL HEMOSTAT: REPLACEMENT OF THE CURRENT SYRINGE CLIP AND SYRINGE SUPPORT COMPONENTS WITH A TWIN SYRINGE DISPENSER, REPLACEMENT OF THE CURRENT JOINER COMPONENT WITH A ROTATING LUER ADAPTER (SYRINGE ADAPTER) TO THE DISTAL LUER CONNECTIONS OF THE EXTENDED APPLICATORS, CHANGES IN MATERIALS OF CONSTRUCTION AND MANUFACTURERS OF THE AFOREMENTIONED COMPONENTS AND UPDATE IN THE PRIMARY PACKAGING. ADDITIONALLY, THE OPTIONAL EXTENDED APPLICATOR DELIVERY ACCESSORIES OF THE VITAGEL RT3 SURGICAL HEMOSTAT, MALLEABLE EXTENDED APPLICATOR (MEA) AND LAPAROSCOPIC EXTENDED APPLICATOR (LEA), AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES REACH 9 MALLEABLE APPLICATOR AND REACH 38 LAPAROSCOPIC APPLICATOR, RESPECTIVELY.
P050050|S006|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM STAR ANKLE|NTG|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/2014|06/04/2014|||APPR|APPROVAL FOR CHANGING THE INNER POUCH MATERIAL FOR THE STAR SLIDING CORE COMPONENT.
P970020|S079|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ULTRA RX AND OTW CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2014|04/07/2014|||OK30|CHANGE TO THE LASER CUTTING EQUIPMENT FOR THE STENT SUB-ASSEMBLY MANUFACTURING PROCESS.
P120010|S017|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2014|04/07/2014|||OK30|NEW LASER SYSTEM BE ADDED TO THE SENSOR FABRICATION PROCESS FOR THE ENLITE SENSOR (MMT-7008).
P810002|S089|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT/STANDARD/MASTERS MECHANICAL HEART VALVES|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2014|03/31/2014|||OK30|CHANGE TO THE PYROLYTIC CARBON COATING PROCESS.
P070027|S040|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2014|04/03/2014|||OK30|VENDOR LOCATION CHANGE.
P840001|S264|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SURESCAN MRI IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2014|04/09/2014|||OK30|CHANGE THE SUB-TIER SUPPLIER FOR A COMPONENT.
P100049|S008|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REGLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2014|04/09/2014|||OK30|CHANGE TO THE DIAMETER FOR THE WELD BALLS THAT ARE AT THE END OF THE LINKS THAT CONNECT THE INDIVIDUAL LINX DEVICE BEADS.
P090018|S025|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM SYSTEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2014|04/08/2014|||OK30|ACCEPTANCE OF A MANUFACTURING PROCESS CHANGE FOR THE ESTEEM SYSTEM.
N18286|S026|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM  (ABSORBLE GELTON)STERILE SPONGE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2014|04/09/2014|||OK30|CHANGES TO THE 10 ML PRE-FILLED 0.9% SODIUM CHLORIDE SOLUTION SYRINGE, PACKAGED WITHIN THE GELFOAM PLUS HEMOSTASIS KITS.
P050050|S007|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)|NTG|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/11/2014|05/09/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970004|S170|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/10/2014|||OK30|CHANGES TO THE COPPER ETCHING PROCESS ON THE PRINTED WIRING BOARD SUBSTRATES.
P080025|S066|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM II  BOWEL NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/10/2014|||OK30|CHANGES TO THE COPPER ETCHING PROCESS ON THE PRINTED WIRING BOARD SUBSTRATES.
P980016|S471|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/02/2014|||OK30|USE OF A JOINING DATA COLLECTION (JDC) APPLICATION IN THEIR MANUFACTURING PROCESS APPLICATION
P010031|S432|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D AND PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/02/2014|||OK30|USE OF A JOINING DATA COLLECTION (JDC) APPLICATION IN THEIR MANUFACTURING PROCESS APPLICATION
P970004|S169|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/11/2014|||OK30|ADDITIONAL IN-PROCESS INSPECTIONS AND TOOLING CHANGES IN THE MANUFACTURING PROCESS OF A COMPONENT OF THE INTERSTIM II NEUROSTIMULATOR, AT THE MEDTRONIC ENERGY AND COMPONENT CENTER.
P080025|S065|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/11/2014|||OK30|ADDITIONAL IN-PROCESS INSPECTIONS AND TOOLING CHANGES IN THE MANUFACTURING PROCESS OF A COMPONENT OF THE INTERSTIM II NEUROSTIMULATOR, AT THE MEDTRONIC ENERGY AND COMPONENT CENTER.
P840001|S265|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/10/2014|||OK30|CHANGES TO THE COPPER ETCHING PROCESS ON THE PRINTED WIRING BOARD SUBSTRATES.
P860004|S203|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/10/2014|||OK30|CHANGES TO THE COPPER ETCHING PROCESS ON THE PRINTED WIRING BOARD SUBSTRATES.
P110013|S037|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/09/2014|||OK30|EXTENSION TO THE RETEST PERIOD FOR ZOTAROLIMUS FROM 12 MONTHS TO 24 MONTHS.
P960009|S191|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA PC IMPLANTABLE NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/10/2014|||OK30|CHANGES TO THE COPPER ETCHING PROCESS ON THE PRINTED WIRING BOARD SUBSTRATES.
P060033|S090|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2014|04/09/2014|||OK30|EXTENSION TO THE RETEST PERIOD FOR ZOTAROLIMUS FROM 12 MONTHS TO 24 MONTHS.
P030017|S191|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/14/2014|06/17/2014|||APPR|APPROVAL FOR THE INFINION CX 16 CONTACT LEAD KIT (MODEL SC-2317-XX) AND ENTRADA NEEDLE (MODEL SC-4220).
P100023|S091|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2014|04/11/2014|||OK30|CHANGE TO YOUR DELIVERY CATHETER ASSEMBLY MANUFACTURING PROCESS.
P020014|S041|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|HHS|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/14/2014|06/29/2015|||APPR|APPROVAL FOR CHANGING THE ESSURE INSTRUCTIONS FOR USE TO REPLACE THE PREVIOUSLY APPROVED MODIFIED HYSTEROSALPINGOGRAM CONFIRMATION TEST WITH THE TRANSVAGINAL ULTRASOUND/ HYSTEROSALPINGOGRAM CONFIRMATION TEST ALGORITH
P040045|S043|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2014|04/10/2014|||OK30|ADDITION OF AN ALTERNATE RAW MATERIAL SUPPLIER.
P080032|S015|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER|OOY|AN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2014|06/17/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.
P890003|S305|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/16/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES.
P010031|S433|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|MAXIMO II CRT-D, CONCERTO, CONCERTO II CRT-D, CONSULTA, INSYNC II & IIIMARQUIS, MAXIMO, SENTRY, MARQUIS INSYNC II PROTEC|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/16/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES.
P090013|S136|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/16/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES.
P010015|S236|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/16/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES.
P030017|S192|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/17/2014|||OK30|UPDATE THE TEST EQUIPMENT SOFTWARE FOR TESTING THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OF THE REMOTE CONTROL (RC).
P980035|S369|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA, ENRHYTHRM MRI|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/16/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES.
P980016|S472|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EN TRUST, VIRTUSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II, INSYNC MARQUIS, PROTECTA DR,XT, DR, PROT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/16/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES.
P030009|S076|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTERGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/17/2014|||OK30|PROPOSED CHANGES AND UPGRADES TO THE CURRENT ELECTROPOLISHING STATION.
P030005|S107|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CRT-P FAMILY|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/15/2014|||APPR|APPROVAL FOR CHANGES IN TRACE COBALT CONTROL LIMIT IN RAW MNO2 ANDTRACE CALCIUM CONTROL LIMIT IN RAW LITHIUM FOIL FOR THE PULSE GENERATOR BATTERIES.
P110029|S017|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/15/2014|||OK30|ADDITION OF A NEWLY CONSTRUCTED ISO CLASS 8 DISPENSARY AREA FOR BUFFER PREPARATION.
P060033|S091|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/17/2014|||OK30|PROPOSED CHANGES AND UPGRADES TO THE CURRENT ELECTROPOLISHING STATION.
N970003|S160|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO PG FAMILIES|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/15/2014|||APPR|APPROVAL FOR CHANGES IN TRACE COBALT CONTROL LIMIT IN RAW MNO2 ANDTRACE CALCIUM CONTROL LIMIT IN RAW LITHIUM FOIL FOR THE PULSE GENERATOR BATTERIES.
P050051|S026|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/15/2014|||OK30|ADDITION OF A NEWLY CONSTRUCTED ISO CLASS 8 DISPENSARY AREA FOR BUFFER PREPARATION.
P120008|S006|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/15/2014|||OK30|ADDITION OF A NEWLY CONSTRUCTED ISO CLASS 8 DISPENSARY AREA FOR BUFFER PREPARATION.
P110013|S038|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STNET SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/17/2014|||OK30|PROPOSED CHANGES AND UPGRADES TO THE CURRENT ELECTROPOLISHING STATION.
P110011|S007|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/17/2014|||OK30|CHANGES AND UPGRADES TO THE CURRENT ELECTROPOLISHING STATION.
P100026|S015|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/14/2014|||OK30|MODIFY AUTOMATED TESTING EQUIPMENT.
P110042|S028|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/15/2014|||OK30|REMOVAL OF REDUNDANT INSPECTIONS IN THE MANUFACTURING PROCESS.
P060039|S058|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/04/2014|||OK30|ALTERNATE PRESS MACHINE AT A SUPPLIER FOR THE MANUFACTURE OF THE RETENTION SLEEVE USED WITH THE ATTAIN STARFIX LEAD.
P100041|S051|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/17/2014|||OK30|ADDITION OF AN ALTERNATE SELF-CONTAINED BIOLOGICAL INDICATOR IN POUCH (SCBIP) USED TO MONITOR EFFECTIVENESS OF ETHYLENE OXIDE STERILIZATION.
P110021|S038|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/17/2014|||OK30|ADDITION OF AN ALTERNATE SELF-CONTAINED BIOLOGICAL INDICATOR IN POUCH (SCBIP) USED TO MONITOR EFFECTIVENESS OF ETHYLENE OXIDE STERILIZATION.
P960043|S088|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE/ AT AND PROSTAR XL|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/17/2014|||OK30|ADDITION OF AN ALTERNATE SELF-CONTAINED BIOLOGICAL INDICATOR IN POUCH (SCBIP) USED TO MONITOR EFFECTIVENESS OF ETHYLENE OXIDE STERILIZATION.
P110042|S029|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/18/2014|08/22/2014|||APPR|APPROVAL FOR THE SOFTWARE MAINTENANCE RELEASE 8.
P980049|S094|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR, PARADYM RF VR/RF DR|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|04/17/2014|||APPR|APPROVAL FOR DESIGN CHANGES TO THE SETSCREWS AND TORQUE SCREWDRIVER USED IN CONNECTING THE LEADS TO IMPLANTABLE DEFIBRILLATORS.
P060027|S061|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750, PARADYM RF CRT-D 9750|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|04/17/2014|||APPR|APPROVAL FOR DESIGN CHANGES TO THE SETSCREWS AND TORQUE SCREWDRIVER USED IN CONNECTING THE LEADS TO IMPLANTABLE DEFIBRILLATORS.
P090022|S020|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/18/2014|06/16/2014|||APPR|APPROVAL TO ALLOW FOR THE DISTRIBUTION OF AN ALTERNATE PACKAGING OF THE PRE-LOADED INJECTOR (PLI) TIPS IN A 12-PACK CARTON.
P960040|S311|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA,ENERGEN,PUNCTUA,TELIGEN IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2014|03/31/2014|||OK30|ALTERNATE PROCESS FOR EXCISING THE PRINTED CIRCUIT BOARDS (PCB) FROM THE PCB PANEL USING A LASER EXCISE SYSTEM.
P010012|S348|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA,ENERGEN,PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2014|03/31/2014|||OK30|ALTERNATE PROCESS FOR EXCISING THE PRINTED CIRCUIT BOARDS (PCB) FROM THE PCB PANEL USING A LASER EXCISE SYSTEM.
P960040|S312|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN,INCEPTA,PUNCTUA,ENERGEN ICDS, INCEPTA, PUNCTUA,ENERGEN CRT-DS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/15/2014|||APPR|APPROVAL FOR CHANGES IN TRACE COBALT CONTROL LIMIT IN RAW MNO2 ANDTRACE CALCIUM CONTROL LIMIT IN RAW LITHIUM FOIL FOR THE PULSE GENERATOR BATTERIES.
P010012|S349|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS CRT-D FAMILY|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/15/2014|||APPR|APPROVAL FOR CHANGES IN TRACE COBALT CONTROL LIMIT IN RAW MNO2 ANDTRACE CALCIUM CONTROL LIMIT IN RAW LITHIUM FOIL FOR THE PULSE GENERATOR BATTERIES.
P000012|S048|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/04/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR A SYSTEM COMPONENT USED IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.
P050028|S041|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/04/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR A SYSTEM COMPONENT USED IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.
P060030|S041|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/04/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR A SYSTEM COMPONENT USED IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.
P110037|S014|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/04/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR A SYSTEM COMPONENT USED IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.
P070015|S121|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V  AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/15/2014|||OK30|CHANGE TO INCREASE THE SPEED AT WHICH THE COBALT CHROMIUM-BASED STENTS ARE LASER CUT.
P120016|S001|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/30/2014|||OK30|ELIMINATE POST-STERILIZATION INSPECTION STEPS AND ADD SUBASSEMBLY QUALITY CONTROL INSPECTION STEPS TO SUBASSEMBLIES.
P020047|S057|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK  VISION / MULTI-LINK MINI VISION / MULTI-LINK 8 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/15/2014|||OK30|CHANGE TO INCREASE THE SPEED AT WHICH THE COBALT CHROMIUM-BASED STENTS ARE LASER CUT.
P110019|S065|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/15/2014|||OK30|CHANGE TO INCREASE THE SPEED AT WHICH THE COBALT CHROMIUM-BASED STENTS ARE LASER CUT.
P010031|S434|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/04/2014|||OK30|ADDITIONAL LEAK CHECK TESTERS, AND THE SOFTWARE UPDATES FOR THE DEVICES CAPACITORS.
P980016|S473|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2014|04/04/2014|||OK30|ADDITIONAL LEAK CHECK TESTERS, AND THE SOFTWARE UPDATES FOR THE DEVICES CAPACITORS.
P980022|S153|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2014|05/29/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE PARADIGM REAL-TIME REVELINSULIN PUMP (MMT-523, MMT-523K, MMT-723, AND MMT-723K) APPLICATION SOFTWARE.  THESE CHANGES INCLUDE CORRECTIONS FOR TWO MOTOR ERROR ANOMALIES AND ENHANCEMENTS FOR THE THRESHOLD SUSPEND FEATURE, INSULIN VALUE SETTING, AND MERGED COMMON CODE BASE. THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME REVEL SYSTEM.
P910001|S070|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHRECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2014|04/17/2014|||OK30|CHANGE TO ESTABLISH THE OPERATING RANGE WITHIN WHICH THE FIBER WINDER CAN SPOOL FIBER FOR THE SLS AND ELCA PRODUCT LINES.
P960042|S048|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATHS (SLS)|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2014|04/17/2014|||OK30|CHANGE TO ESTABLISH THE OPERATING RANGE WITHIN WHICH THE FIBER WINDER CAN SPOOL FIBER FOR THE SLS AND ELCA PRODUCT LINES.
P050047|S036|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2014|04/14/2014|||OK30|CHANGES TO THE ISO CLASSIFICATION OF THE SYRINGE DRYING, 100% VISUAL INSPECTION, SYRINGE ASSEMBLY AND THERMOFORMED TRAY PACKAGING ROOMS.
P110033|S005|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2014|04/14/2014|||OK30|CHANGES TO THE ISO CLASSIFICATION OF THE SYRINGE DRYING, 100% VISUAL INSPECTION, SYRINGE ASSEMBLY AND THERMOFORMED TRAY PACKAGING ROOMS.
P980035|S371|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2014|04/11/2014|||OK30|ADDITION OF AN AUTOMATED ELECTRICAL TESTER AT SUPPLIER (MEGGITT) FOR THE  DEVICES.
P100022|S010|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG ELUTING PERIPHERAL STENT|NIU|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2014|01/07/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.
P050017|S009|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER FLEX 35 VASCULAR STENT|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2014|01/07/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.
P080004|S015|HOYA SURGICAL OPTICS, INC.|14768 PIPELINE AVENUE||CHINO HILLS|CA|91709||intraocular lens|ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2014|06/16/2014|||APPR|APPROVAL FOR AN OPTICAL DESIGN CURVATURE MODIFICATION TO THE ISERT® MODEL 251 TO ADD A CONTROLLED POSITIVE SPHERICAL ABERRATION TO THE OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT® GEMETRIC MODEL 751 AND IS INDICATEDFOR IMPLANTATION AFTER EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION OF CATARACTS IN ADULTS. THIS LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
P900056|S134|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2014|04/17/2014|||OK30|NEW VENDOR FOR THE ROTALINK BRAKE SPRING UTILIZED IN THE ROTABLATOR ADVANCER, A COMPONENT OF THE ROTABLATOR ATHERECTOMY SYSTEM.
P090022|S021|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC INTRAOCULAR LENSES (IOLS)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2014|04/17/2014|||OK30|ADDITION OF A STEAM STERILIZER.
P830055|S142|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/19/2014|04/18/2014|||APPR|APPROVAL FOR CHANGES TO THE LABELING (SURGICAL TECHNIQUE) THAT ADD OR STRENGTHEN AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.
P010031|S435|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D,VIVA S CRT-D, VIVA XT CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2014|05/13/2014|||APPR|APPROVAL FOR A REPLACEMENT TELEMETRY M COMPONENT ANDASSOCIATED MANUFACTURING CHANGES.
P980016|S474|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/19/2014|05/13/2014|||APPR|APPROVAL FOR A REPLACEMENT TELEMETRY M COMPONENT ANDASSOCIATED MANUFACTURING CHANGES.
P980035|S370|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2014|04/15/2014|||OK30|NEW EQUIPMENT IN THE FINAL PACKAGING LINES AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY.
P010031|S436|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2014|04/15/2014|||OK30|NEW EQUIPMENT IN THE FINAL PACKAGING LINES AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY.
P090013|S137|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2014|04/15/2014|||OK30|NEW EQUIPMENT IN THE FINAL PACKAGING LINES AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY.
P980016|S475|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD,PROTECTA ICD, PROTECTA|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2014|04/15/2014|||OK30|NEW EQUIPMENT IN THE FINAL PACKAGING LINES AT THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY.
P100034|S009|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOTTF-100A TREATMENT KIT|NZK|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/20/2014|07/25/2014|||APPR|APPROVAL TO REPLACE THE CURRENT TYVEK POUCH PACKAGING MATERIAL FORTHE INE TRANSDUCER ARRAYS WITH AN ALUMINUM FOIL MOISTURE BARRIER AND TO EXTEND THE SHELF LIFE FOR THESE TRANSDUCER ARRAYS FROM 6 TO 9 MONTHS.
P100023|S092|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM OVER THE WIRE|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2014|04/17/2014|||OK30|CHANGE TO THE MANUAL STEPS OF THE STENT CRIMPING MANUFACTURING PROCESS.
P890064|S030|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HC2 STSTEM SOFTWARE|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|03/21/2014|05/12/2014|||APPR|APPROVAL FOR THE UPGRADE OF THE HC2 SOFTWARE SUITE TO VERSION 4.2.
P070015|S122|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/2014|10/03/2014|14M-1596|10/29/2014|APPR|APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, AND XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO INCLUDE DE NOVO TOTAL CORONARY OCCLUSIONS.. THESE DEVICES ARE INDICATED FOR THE FOLLOWING:XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMTHE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <=28MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25MM TO 4.25MM. ADDITIONALLY, THE XIENCE V STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.  XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM.  THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32MM) WITH REFERENCE VESSEL DIAMETERS OF >=2.25MM TO >=4.25MM.  FOR ADDITIONAL INFO PLEASE REFER TO APPROVAL ORDER.
P110019|S066|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/2014|10/03/2014|14M-1596|10/29/2014|APPR|APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE OF THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, AND XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM TO INCLUDE DE NOVO TOTAL CORONARY OCCLUSIONS.. THESE DEVICES ARE INDICATED FOR THE FOLLOWING:XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMTHE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <=28MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25MM TO 4.25MM. ADDITIONALLY, THE XIENCE V STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.  XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM.  THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32MM) WITH REFERENCE VESSEL DIAMETERS OF >=2.25MM TO >=4.25MM.  FOR ADDITIONAL INFO PLEASE REFER TO APPROVAL ORDER.
P120010|S019|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|GLUCOSE SENSOR ENLITE|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/21/2014|06/18/2014|||APPR|APPROVAL FOR CHANGES TO THE ENLITE GLUCOSE SENSOR (MMT-7008A, MMT-7008B) OF THE MINIMED 530G SYSTEM.  SPECIFICALLY, THE SUPPLEMENT REQUESTED DESIGN MODIFICATIONS TO THE NEEDLE HUB AND NEEDLE CARRIER COMPONENTS OF THE ENLITE SENSOR TO FIT THE AUTOMATION MACHINE THAT WILL BE USED FOR THE SENSOR ASSEMBLY. ADDITIONALLY, THE NEW MANUFACTURING PROCESS WILL TAKE PLACE IN THE JUNCOS, PUERTO RICO MANUFACTURING SITE.
P060040|S034|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/09/2014|||OK30|ADDITION OF A SECOND SUPPLIER FOR THE EMERGENCY BACKUP BATTERY (EBB).
P100013|S010|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE (VCD)|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/23/2014|||OK30|BRING MANUFACTURING OF AN INJECTION MOLDED COMPONENT IN-HOUSE AND REPLACE THE SINGLE- WITH THE MULTI-CAVITY MOLDING PROCESS.
P030017|S193|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/21/2014|||OK30|ADDITION OF A CLEANING STEP TO THE CABLE MANUFACTURING PROCESS.
P110038|S004|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/16/2014|||OK30|INCREASE IN STERILIZATION CYCLE CAPACITY.
P060002|S035|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|BARD FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/23/2014|||OK30|NEW MEASURING EQUIPMENT FOR USE IN INCOMING QUALITY CONTROL (IQC) INSPECTIONS.
P080007|S020|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, ILIAC|BARD E-LUMINEXX VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/23/2014|||OK30|NEW MEASURING EQUIPMENT FOR USE IN INCOMING QUALITY CONTROL (IQC) INSPECTIONS.
P070014|S043|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/23/2014|||OK30|NEW MEASURING EQUIPMENT FOR USE IN INCOMING QUALITY CONTROL (IQC) INSPECTIONS.
P020036|S026|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART AND SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/16/2014|||OK30|ADD AN ADDITIONAL SEMI-AUTOMATED INSPECTION STEP TO THE CURRENT POUCH SEALING INSPECTION.
P120002|S001|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|SMART AND SMART CONTROL VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2014|04/16/2014|||OK30|ADD AN ADDITIONAL SEMI-AUTOMATED INSPECTION STEP TO THE CURRENT POUCH SEALING INSPECTION.
P980049|S095|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM RF VR|MRM|CV|30-Day Notice||N|03/24/2014|04/16/2014|||OK30|CHANGES FOR THE DEVICES (PLATFORM ZL102):1) ADDED EQUIPMENT COOLER STACKER/DE-STACKER USED IN THE ELECTRONIC SMD ASSEMBLY LINE;2) LASER WELDING PROCESS REWORK FOR VISUAL DEFECT ON CASE; AND3. PARADYM RF (ZL102), IN SOURCING OF RF MODULE MANUFACTURING
P060027|S062|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF CRT-D|NIK|CV|30-Day Notice||N|03/24/2014|04/16/2014|||OK30|CHANGES FOR THE DEVICES (PLATFORM ZL102):1) ADDED EQUIPMENT COOLER STACKER/DE-STACKER USED IN THE ELECTRONIC SMD ASSEMBLY LINE;2) LASER WELDING PROCESS REWORK FOR VISUAL DEFECT ON CASE; AND3. PARADYM RF (ZL102), IN SOURCING OF RF MODULE MANUFACTURING
P010030|S049|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2014|05/19/2014|||APPR|APPROVAL FOR 29 ROHS COMPLIANT ALTERNATE COMPONENTS, 7 ROHS COMPLIANT ALTERNATE BARE-BOARD SUBASSEMBLIES, AND 6 ROHS COMPLIANT ALTERNATE CABLE SUBASSEMBLIES FOR USE IN THE LIFEVEST WEARABLE DEFIBRILLATOR.
P880086|S240|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY, ASSURITY+ AND ENDURITY FAMILIES OF PACEMAKER DEVICES|NVZ|CV|30-Day Notice||N|03/25/2014|04/04/2014|||OK30|ALTERNATE BURN-IN (BI) FOR THE ENVIRONMENTAL SCREENING USED DURING THE MANUFACTURE OF THE DEVICES.
P020004|S092|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2014|06/20/2014|||APPR|APPROVAL FOR DELIVERY SYSTEM PROFILE REDUCTION (23, 26MM DEVICESREDUCED FROM 18F TO 16F), SLEEVE CONSTRUCT MODIFICATIONS, AND DELIVERY CATHETER MODIFICATIONS.
P030035|S118|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ALLURE AND ALLURE QUADRA FAMILIES OF CRT-P DEVICES|NIK|CV|30-Day Notice||N|03/25/2014|04/04/2014|||OK30|ALTERNATE BURN-IN (BI) FOR THE ENVIRONMENTAL SCREENING USED DURING THE MANUFACTURE OF THE DEVICES.
P850010|S050|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2014|04/23/2014|||OK30|QUALIFICATION OF A SEALING TOOL FOR USE ON THE ALLOYD HEAT SEAL MACHINE.
P060028|S001|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS|FTR|SU|Normal 180 Day Track||N|03/26/2014|09/09/2014|||APPR|APPROVAL FOR FOUR ADDITIONAL MEMORYSHAPE¿ BREAST IMPLANT STYLES (MM+, MH, TM+ AND LM+).
P910056|S016|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2014|04/25/2014|||OK30|ADDITION OF A MANUFACTURING CLEANROOM, ISO CLASS 7 AT THE CLEARWATER, FLORIDA FACILITY.
P010031|S437|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S  CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2014|04/10/2014|||OK30|CHANGE TO THE IN-PROCESS INSPECTION CRITERIA FOR BATTERY CELLS FOR THE DEVICES.
P980016|S476|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA  XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2014|04/10/2014|||OK30|CHANGE TO THE IN-PROCESS INSPECTION CRITERIA FOR BATTERY CELLS FOR THE DEVICES.
P130021|S003|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALUE TM SYSTEM,|NPT|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/27/2014|04/03/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE LABELING TO CLARIFY THE INDICATIONS FOR USE AND THE INSTRUCTIONS FOR POST-IMPLANTATION DILATATION.
P040016|S126|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P060006|S058|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P100023|S093|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P110010|S078|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P890003|S307|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|MYCARELINK PATIENT MONITOR|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/29/2014|||APPR|APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
P980016|S478|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD, MARQUIS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/29/2014|||APPR|APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
P980035|S373|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG, ENPULSE E1 IPG,ENPULSE E2 IPG, KAPPA D(KAPPA 700)IPG, KAPPA D(K|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/29/2014|||APPR|APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
P970051|S118|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/25/2014|||OK30|ACCEPTANCE OF A SUPPLIER MANUFACTURING PROCESS CHANGE.
P900056|S135|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P920047|S068|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II  CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P980003|S048|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P020009|S120|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER THE WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P020025|S056|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/23/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P890003|S306|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/23/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT MONITOR24950.
P980016|S477|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD,INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/23/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT MONITOR24950.
P980035|S372|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA,IPG,ADVISA DR IPG,ADVISA DR MRI IPG,ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700)IPG,KAPPA D|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/23/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT MONITOR24950.
P010015|S237|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/23/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT MONITOR24950.
P010031|S438|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|BRAVA,CONCERTO II, MAXIMO II PRTECTA CRT-D,CONCERTO CONSULTA,INSYNC II PROTECT, INSYNC III MARQUIS , INSYNC MAXIMOICD|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/23/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT MONITOR24950.
P090013|S138|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/23/2014|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT MONITOR24950.
P010031|S440|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/23/2014|||APPR|APPROVAL FOR THE CHANGES OF THE DEFORMATION ELEMENT (DE) IN THE HIGH VOLTAGE CAPACITOR ELECTRICAL FEEDTHROUGH FOR THE DEVICES.
P980016|S479|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/23/2014|||APPR|APPROVAL FOR THE CHANGES OF THE DEFORMATION ELEMENT (DE) IN THE HIGH VOLTAGE CAPACITOR ELECTRICAL FEEDTHROUGH FOR THE DEVICES.
P010015|S238|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/29/2014|||APPR|APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
P010031|S439|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D, CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC II PROTECT ICD,INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/29/2014|||APPR|APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
P090013|S139|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/28/2014|05/29/2014|||APPR|APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
P900056|S136|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/24/2014|||OK30|ADDITION OF AN ALTERNATE MICROBIOLOGY LABORATORY FOR THE TESTING OF BIOBURDEN FOR THE ROTAWIRE WITH WIRE CLIP TORQUER.
P840001|S266|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL/ RESTORE/ SYNERGY/  SCS IMPLANTABLE NEUROSTIMULATOR SYSTEM FAMILIES|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/24/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P110002|S005|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/28/2014|07/15/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110009|S005|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVELS)|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/28/2014|07/15/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P080025|S067|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/24/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P860004|S204|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II DRUG DELIVERY INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/24/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P960009|S192|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA/ KINETRA/ SOLETRA IMPLANTABLE DEEP BRAIN STIMULATION SYSTEM FAMILIES|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/24/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P970004|S171|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM/ INTERSTIM II SACRAL NERVE STIMULATION SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/24/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
P130016|S001|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2014|04/25/2014|||OK30|ACCEPTANCE OF A SUPPLIER MANUFACTURING PROCESS CHANGE.
P900056|S137|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE|MCX|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P920047|S069|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P980003|S049|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P020009|S121|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE|MAF|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P020025|S057|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P040016|S127|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P060006|S059|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P100023|S094|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P040044|S051|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/24/2014|||OK30|IMPLEMENTATION OF A NEW FROST FAN FIXTURE.
P000012|S049|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/28/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR SUBASSEMBLIES IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.
P050028|S042|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/28/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR SUBASSEMBLIES IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.
P060030|S042|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/28/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR SUBASSEMBLIES IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.
P110037|S015|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/28/2014|||OK30|ADDITION OF A NEW SUPPLIER FOR SUBASSEMBLIES IN THE MANUFACTURE OF THE COBAS AMPLIPREP INSTRUMENT.
P110010|S079|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice||N|03/31/2014|05/01/2014|||OK30|CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
P120020|S001|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/30/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS IN LOS ANGELES, CALIFORNIA.
P860057|S122|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/30/2014|||OK30|ADDITION OF AN ALTERNATE WIREFORMING MACHINE.
P840001|S267|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS)|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2014|04/30/2014|||APPR|APPROVAL TO PROVIDE CORRECTIONS TO THE LABELING RELATED TO THE CYCLING FEATURE (ALTERNATING BETWEEN THERAPY OFF AND ON) IN SOME NEUROSTIMULATION DEVICES USED FOR SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
P960009|S193|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|NEUROSTIMULATION SYSTEM FOR DEEP BRAIN STIMULATION (DBS)|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/31/2014|04/30/2014|||APPR|APPROVAL TO PROVIDE CORRECTIONS TO THE LABELING RELATED TO THE CYCLING FEATURE (ALTERNATING BETWEEN THERAPY OFF AND ON) IN SOME NEUROSTIMULATION DEVICES USED FOR SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
P040044|S052|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/30/2014|||OK30|REDUCTION IN THE POUCH SEAL SAMPLING PLAN.
P110033|S006|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2014|04/28/2014|||OK30|REMOVAL OF TWO IN-PROCESS CONTROL TESTS USED DURING THE MANUFACTURE OF JUVÉDERM VOLUMA XC.
P120016|S002|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/31/2014|10/07/2014|||APPR|APPROVAL FOR THE ADDITION OF COLORANT IN THE PUSH ROD COMPONENT OFTHE VASCADE VASCULAR CLOSURE SYSTEM.
P030050|S021|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AND SCULPTRA AESTHETIC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|04/29/2014|||OK30|REPLACEMENT OF THE MOTOR FOR A HOPPER AND SUBSEQUENT REQUALIFICATION OF THAT HOPPER AT THE  FIRM¿S MANUFACTURING FACILITY.
P040044|S053|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|05/01/2014|||OK30|IMPLEMENTATION OF A DIFFERENT STERILIZATION CONFIGURATION FOR THE MYNX® PRODUCT FAMILY OF DEVICES.
P050042|S029|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|04/28/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A MATERIAL USED IN THE MANUFACTURE OF AN ARCHITECT ANTI-HCV COMPONENT.
P860057|S123|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|05/01/2014|||OK30|ADDITION OF AN ALTERNATE TISSUE SUPPLIER.
P100041|S052|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|05/01/2014|||OK30|ADDITION OF AN ALTERNATE TISSUE SUPPLIER.
P110021|S039|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|05/01/2014|||OK30|ADDITION OF AN ALTERNATE TISSUE SUPPLIER.
P010013|S054|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/01/2014|05/30/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010031|S441|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVACRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|05/02/2014|||OK30|TEST CHANGES TO THE TELEMETRY MODULE.
P890003|S308|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|05/02/2014|||OK30|TEST CHANGES TO THE TELEMETRY MODULE.
P980016|S480|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2014|05/02/2014|||OK30|TEST CHANGES TO THE TELEMETRY MODULE.
P080006|S068|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/01/2014|08/01/2014|||APPR|APPROVAL FOR THE ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD, INDICATED FOR CHRONIC PACING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM.
P120005|S017|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCON G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2014|05/02/2014|||OK30|CHANGE FOR THE METHOD OF MEASUREMENT OF CRITICAL DIMENSIONS DURING RECEIVING INSPECTION OF THE DEXCOM G4 PLATINUM TRANSMITTER TRAY, AND THE USE OF A FOOD GRADE SILICONE SPRAY DURING MANUFACTURING OF THE TRANSMITTER TRAY.
P020004|S093|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2014|05/02/2014|||OK30|ADDITION OF AN AUTOMATED DUAL HEAD WRAPPER.
P840064|S056|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT, DUOVISC,DISCOVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2014|04/29/2014|||OK30|USE OF A NEW RAW MATERIAL IN THE RUBBER FORMULATION OF THE TIP CAPS USED FOR THEIR VISCOAT, DUOVISC, DISCOVISC, AND PROVISC OVD. THE SUBMISSION ALSO REQUESTED A MATERIALADDITION TO OPTIMIZE THE PLACEMENT OF THE TIP CAP FOR THE VISCOAT.
P100026|S016|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2014|05/01/2014|||OK30|ADD ALTERNATE EQUIPMENT.
P130016|S002|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/02/2014|07/01/2014|||APPR|APPROVAL FOR AN MR INDICATION AT 1.5 TESLA UNDER SPECIFIC SCANNING CONDITIONS WITH THE MAGNET SURGICALLY REMOVED PRIOR TO THE MR SCAN, FOR THE HYBRID L24 IMPLANT SYSTEM.
P890047|S043|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2014|04/29/2014|||OK30|USE OF A NEW RAW MATERIAL IN THE RUBBER FORMULATION OF THE TIP CAPS USED FOR THEIR VISCOAT, DUOVISC, DISCOVISC, AND PROVISC OVD. THE SUBMISSION ALSO REQUESTED A MATERIALADDITION TO OPTIMIZE THE PLACEMENT OF THE TIP CAP FOR THE VISCOAT.
P040045|S044|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2014|04/29/2014|||OK30|CHANGE TO THE STENT SUB-ASSEMBLY MANUFACTURING EQUIPMENT.
P950039|S028|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP SLIDES|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2014|04/24/2014|||OK30|ADDITION OF A NEW RAW MATERIAL SUPPLIER FOR FLOAT GLASS USED TO MANUFACTURE THE THINPREP PAP TEST MICROSCOPE SLIDE.
P030017|S194|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2014|05/02/2014|||OK30|ADD AN ALTERNATE WIRE BONDER.
P000025|S077|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/03/2014|06/24/2014|||APPR|APPROVAL FOR THE MAX PROGRAMMING INTERFACE AND THE ASSOCIATEDMAESTRO 5.0 PROGRAMMING SOFTWARE UPDATE.
P070001|S013|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|SYNTHES PRODISC-C TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2014|08/27/2014|||APPR|APPROVAL FOR A CHANGE TO THE METHOD USED FOR ESTABLISHMENT OF THE BIOBURDEN ALERT AND ACTION LEVELS FOR DOSE AUDITING OF SYNTHES PRODISC-C AND PRODISC-L TOTAL DISC REPLACEMENT DEVICES.
P050010|S016|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|SYNTHES PRODISC-L TOTAL DISC REPLACEMENT|MJO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2014|08/27/2014|||APPR|APPROVAL FOR A CHANGE TO THE METHOD USED FOR ESTABLISHMENT OF THE BIOBURDEN ALERT AND ACTION LEVELS FOR DOSE AUDITING OF SYNTHES PRODISC-C AND PRODISC-L TOTAL DISC REPLACEMENT DEVICES.
P010068|S039|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS DS CATHETER, NAVISTAR DS CATHETER|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2014|07/02/2014|||APPR|APPROVAL FOR APPLYING A CHANGE IN STERILIZATION RELEASE METHOD TO THE NEW LINE OF CATHETERS AT THE SANTA TERESA, NEW MEXICO FACILITY.
P950005|S050|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS CATHETER, CELSIUS RMT CATHETER|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2014|07/02/2014|||APPR|APPROVAL FOR APPLYING A CHANGE IN STERILIZATION RELEASE METHOD TO THE NEW LINE OF CATHETERS AT THE SANTA TERESA, NEW MEXICO FACILITY.
P030011|S024|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/03/2014|07/02/2014|||APPR|APPROVAL FOR USE OF THE SYNHALL VALVE IN THE SYNCARDIA TEMPORARY TOTALARTIFICIAL HEART (TAH-T).
P030009|S077|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2014|05/02/2014|||OK30|UPGRADE TO THE WIRE FORMING MACHINE THAT IS CURRENTLY USED ON INTEGRITY STENTS.
P110013|S039|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2014|05/02/2014|||OK30|UPGRADE TO THE WIRE FORMING MACHINE THAT IS CURRENTLY USED ON INTEGRITY STENTS.
P040044|S054|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY.  (MYNX PRODUCT FAMILY)|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/03/2014|06/18/2014|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING PROCESS CHANGES TO THE O-RING COMPONENT FOR THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY.
P010054|S023|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2014|06/12/2014|||APPR|APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
P090008|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV|MZO|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2014|06/12/2014|||APPR|APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
P030017|S195|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISSION SPINAL CORD SIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2014|05/02/2014|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER FOR THICK FILM RESISTORS.
P990012|S021|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBS AG|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2014|06/12/2014|||APPR|APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
P100031|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2014|06/12/2014|||APPR|APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
P960040|S313|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, TELIGEN, ENERGEN, INCEPTA ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2014|05/01/2014|||OK30|MANUFACTURING CHANGES TO THE CAPACITOR PARYLENE MEASUREMENT.
P010012|S350|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, COGNIS, ENERGY, & INCEPTA CRT-D'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2014|05/01/2014|||OK30|MANUFACTURING CHANGES TO THE CAPACITOR PARYLENE MEASUREMENT.
P110022|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELESYS ANTI-HBC IGM|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2014|06/12/2014|||APPR|APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
P990056|S021|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2014|06/12/2014|||APPR|APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
P110002|S006|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2014|05/02/2014|||OK30|MODIFICATIONS TO SEVERAL FINAL INSPECTIONS.
P110009|S006|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2014|05/02/2014|||OK30|MODIFICATIONS TO SEVERAL FINAL INSPECTIONS.
P970003|S169|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC)|MUZ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2014|07/02/2014|||APPR|APPROVAL FOR A CHANGE TO THE PRINTED CIRCUIT BOARD ASSEMBLYMANUFACTURING DESIGN REQUIREMENT FOR VOLTAGE MEASUREMENT ACCURACY AND TOLERANCE ASSOCIATED WITH ITS ELECTRICAL TESTING.
P000027|S019|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2014|06/12/2014|||APPR|APPROVAL FOR RELEASE OF COBAS 8000 SOFTWARE VERSION 04-01 AND COBAS 8000 DATA MANAGER SOFTWARE VERSION 1.03.
P110010|S080|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PALTINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIR|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2014|05/01/2014|||OK30|CHANGE TO THE STENT INSPECTION REQUIREMENTS.
P100023|S095|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2014|05/01/2014|||OK30|CHANGE TO THE STENT INSPECTION REQUIREMENTS.
P900056|S138|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2014|05/05/2014|||OK30|CHANGE TO THE INCOMING INSPECTION SITE FOR THE ROTABLATOR CONSOLE COMPONENTS FROM FREMONT, CALIFORNIA TO SAN JOSE, CALIFORNIA.
P100023|S096|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2014|04/24/2014|||OK30|IMPLEMENT CHANGES THAT WILL OPTIMIZE THE RESIN DRYING PROCESS FOR THE CATHETER MANUFACTURE.
P110010|S081|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2014|04/24/2014|||OK30|IMPLEMENT CHANGES THAT WILL OPTIMIZE THE RESIN DRYING PROCESS FOR THE CATHETER MANUFACTURE.
P120005|S018|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITIORING SYSTEM|MDS|CH|Panel Track|Change Design/Components/Specifications/Material|N|04/23/2014|10/21/2014|14M-1735|11/12/2014|APPR|APPROVAL FOR THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS DEVICE IS INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G4 PLATINUM SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G4 PLATINUM SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G4 PLATINUM SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P120020|S002|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM (SUPERB)|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/08/2014|10/20/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P880086|S241|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY, ASSURITY +, AND ENDURITY OF PACEMAKER DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2014|04/24/2014|||OK30|ALTERNATE FINAL ASSEMBLY MATERIAL FOR USE IN HYBRID ASSEMBLIES.
P030035|S119|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ALLURE AND ALLURE QUADRA FAMILIES OF CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2014|04/24/2014|||OK30|ALTERNATE FINAL ASSEMBLY MATERIAL FOR USE IN HYBRID ASSEMBLIES.
P010032|S078|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI AND  PROGEGE IMPLANTABLE NEUROSTIMULATION DEVICE|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/08/2014|07/07/2014|||APPR|APPROVAL FOR UPDATING FIRMWARE FROM VERSION 3.0 TO VERSION 3.0.1 FOREON MINI (MODEL 3788) AND PROTÉGÉ (MODEL 2789) IMPLANTABLE PULSE GENERATOR THAT ARE USED IN SPINAL CORD STIMULATION THERAPY.
P990071|S027|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|SMARTABLATE SYSTEM  (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION)|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/2014|07/02/2014|||APPR|APPROVAL FOR HARDWARE MODIFICATIONS TO THE SMARTABLATE IRRIGATION PUMP THAT UPDATE THE HARDWARE FROM VERSION 1 TO VERSION 2.
P040016|S128|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2014|04/24/2014|||OK30|IMPLEMENT CHANGES THAT WILL OPTIMIZE THE RESIN DRYING PROCESS FOR THE CATHETER MANUFACTURE.
P020009|S122|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2014|04/24/2014|||OK30|IMPLEMENT CHANGES THAT WILL OPTIMIZE THE RESIN DRYING PROCESS FOR THE CATHETER MANUFACTURE.
P090003|S031|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2014|04/24/2014|||OK30|IMPLEMENT CHANGES THAT WILL OPTIMIZE THE RESIN DRYING PROCESS FOR THE CATHETER MANUFACTURE.
P050052|S052|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE (+) LIDOCAINE DERMAL FILTER|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/09/2014|01/30/2015|||APPR|APPROVAL FOR MODIFICATION TO THE FORMULATION, SYRINGE MATERIAL, SPECIFICATIONS, MANUFACTURING PROCESS AND LABELING TO SUPPORT THE ADDITION OF THE LIDOCAINE AND IMPROVE MANUFACTURING EFFICACY. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME,RADIESSE® (+) AND IS INDICATED FOR SUB-DERMAL IMPLANTATION THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, INCLUDING NASOLABIAL FOLDS.
P970029|S026|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TMR SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/09/2014|05/07/2014|||APPR|APPROVAL FOR INCLUDING THE POST APPROVAL STUDY LABELING CHANGES OF THE PEARL 8.0 DEVICE INTO THE INSTRUCTIONS FOR USE OF THE PEARL 5.0 AND THE SOLOGRIP III HANDPIECES AS WELL AS ADDING SOME CLARIFYING STATEMENTS TO ENSURE THE SAFE HANDLING OF THE HANDPIECES.
P110042|S031|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBSUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2014|04/29/2014|||OK30|REMOVE THE ELECTRICAL ISOLATION PROCESS MONITOR FROM THE MANUFACTURING PROCESS.
P040044|S055|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|THE MYNX VASCULAR CLOSURE DEVICE PRODCUT FAMILY|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|05/08/2014|||OK30|MANUFACTURING PROCESS CHANGES FOR CUTTING AND DRYING THE HYDROGEL CAKES OF THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY.
P840062|S038|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE/COLLATAPE/COLLA[LUG ABSORBABLE COLLAGEN WOUND DRESS|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|04/28/2014|||OK30|ENHANCEMENTS FOR THE LYOPHILIZER CHAMBER VACUUM CONTROL.
P810006|S051|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT/INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|04/28/2014|||OK30|ENHANCEMENTS FOR THE LYOPHILIZER CHAMBER VACUUM CONTROL.
P850010|S051|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|04/28/2014|||OK30|ENHANCEMENTS FOR THE LYOPHILIZER CHAMBER VACUUM CONTROL.
P790002|S032|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET EBI BONE HEALING SYSTEM|LOF|OR|30-Day Notice||N|04/10/2014|05/09/2014|||OK30|ADDITION OF NEW LABELING EQUIPMENT.
P850022|S022|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM|LOF|OR|30-Day Notice||N|04/10/2014|05/09/2014|||OK30|ADDITION OF NEW LABELING EQUIPMENT.
P100026|S017|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2014|07/09/2014|||APPR|APPROVAL TO USE 20 MICRON THICK SEPARATORS IN THE QMR MODEL 2570BATTERY.
P100021|S034|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|05/06/2014|||OK30|CHANGE TO THE STERILIZATION LOAD CONFIGURATION.
P840062|S039|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE,COLLATAPE,COLLAPLUG ABSORBABLE COLLAGEN WOUND GRESSING FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|05/07/2014|||OK30|QUALIFICATION OF A NEW AIRLOCK ROOM.
P810006|S052|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|05/07/2014|||OK30|QUALIFICATION OF A NEW AIRLOCK ROOM.
P850010|S052|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|05/07/2014|||OK30|QUALIFICATION OF A NEW AIRLOCK ROOM.
P900033|S034|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|05/07/2014|||OK30|QUALIFICATION OF A NEW AIRLOCK ROOM.
P950029|S090|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|04/21/2014|||OK30|CHANGES TO IN-PROCESS VERIFICATIONS ON THE ELECTRONIC ASSEMBLY LINE.
P980049|S096|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750, PARADYM DR 8750,PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101),|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|04/21/2014|||OK30|CHANGES TO IN-PROCESS VERIFICATIONS ON THE ELECTRONIC ASSEMBLY LINE.
P060027|S063|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101),PARADYM RF CRT-D9750 (ZL102)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2014|04/21/2014|||OK30|CHANGES TO IN-PROCESS VERIFICATIONS ON THE ELECTRONIC ASSEMBLY LINE.
P130021|S004|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE (R) SYSTEM|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/10/2014|09/02/2014|||APPR|APPROVAL FOR A NEW COMPRESSION LOADING SYSTEM (G4 CLS), A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH WESTPORT LIMITED, SYNERGY HEALTH PLACE, LODGE ROAD, WESTPORT,CO., MAYO, IRELAND, AND THE GAMMA STERILIZATION OF THE FINISHED G4 CLS.
P100040|S019|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2014|05/06/2014|||OK30|CHANGE TO THE STERILIZATION LOAD CONFIGURATION.
P010031|S442|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VIVA QUAD XT CRT-D,VIVA QUAD S CRT-D,BRAVA QUAD CRT-D,VIVA QUAD C CRT-D,VIVA/BRAVA/EVERA SOFTWARE APPLICATION|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/11/2014|07/03/2014|||APPR|APPROVAL FOR THE VIVA/BRAVA QUADRIPOLAR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES AND IS INDICATED FOR PATIENTS WHO REQUIRE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE- THREATENING VENTRICULAR ARRHYTHMIAS, FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK FOR DEVELOPING ATRIAL TACHYARRHYTHMIAS AND FOR PROVIDING CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS ON STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED, AND MEET ANY OF THE CLASSIFICATIONS PROVIDED IN THE LABELING.
P890003|S309|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA)|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/11/2014|07/03/2014|||APPR|APPROVAL FOR THE VIVA/BRAVA QUADRIPOLAR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICES AND IS INDICATED FOR PATIENTS WHO REQUIRE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE- THREATENING VENTRICULAR ARRHYTHMIAS, FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK FOR DEVELOPING ATRIAL TACHYARRHYTHMIAS AND FOR PROVIDING CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS ON STABLE, OPTIMAL HEART FAILURE MEDICAL THERAPY IF INDICATED, AND MEET ANY OF THE CLASSIFICATIONS PROVIDED IN THE LABELING.
P120010|S020|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2014|05/08/2014|||OK30|CHANGE TO THE LASER CUTTING PROGRAM PARAMETERS OF THE RESONETICS GALVO LASER SYSTEM.
P120010|S021|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR, ENLITE GLUCOSE SENSOR (MMT-7008)|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2014|07/10/2014|||APPR|APPROVAL TO LOWER THE PURITY SPECIFICATION LIMIT FOR THE CHROMIUMLAYER ON ENLITE¿ GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOF¿ GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM REAL-TIME REVEL SYSTEM.
P050037|S048|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2014|05/07/2014|||OK30|AUTOMATION OF THE FILLING PROCESS FOR THE RADIESSE PRODUCT.
P050052|S053|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2014|05/07/2014|||OK30|AUTOMATION OF THE FILLING PROCESS FOR THE RADIESSE PRODUCT.
P980022|S154|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF GLUCOSE SENSOR, SOF GLUCOSE SENSOR (MMT-7002, MMT-7003)|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2014|07/10/2014|||APPR|APPROVAL TO LOWER THE PURITY SPECIFICATION LIMIT FOR THE CHROMIUMLAYER ON ENLITE¿ GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOF¿ GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM REAL-TIME REVEL SYSTEM.
P840062|S040|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE,COLLATAPE,COLLAPLUG ABSORABLE COLLAGEN WOUND DRESS|LPG|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2014|10/17/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.
P810006|S053|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS-MICROFIBRILLAR FORM, COLLASTAT ABSORABLE COLAGEN HEMOSTATIC SPONGE|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2014|10/17/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.
P850010|S053|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2014|10/17/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.
P090016|S009|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/11/2014|08/06/2015|||APPR|APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
P900033|S035|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2014|10/17/2014|||APPR|APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.
P980022|S155|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL TIME INSULIN PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR.|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|05/14/2014|||OK30|NEW TOOL TO BE USED IN THE PROCESS OF CURING THE VIBRATOR MOTOR TO THE VIBRATOR MOTOR HOUSING IN THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K), A COMPONENT OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM, THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), A COMPONENT OF THE PARADIGM REAL-TIME REVELCONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM.
P110004|S003|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY SENT ON RX|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|05/12/2014|||OK30|ADDITION OF A NEW CLEAN ROOM TO THE MEDINOL JERUSALEM MANUFACTURING PLANT.
P110042|S032|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|04/28/2014|||OK30|BOSTON SCIENTIFIC CORPORATION (BSC) TO BE THE SECOND SUPPLIER FOR THEMANUFACTURE PROCESS OF THE HIGH VOLTAGE CAPACITOR LIDS TO BE USED IN THE DEVICE.
P110023|S007|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/2014|10/10/2014|14M-1599|10/24/2014|APPR|APPROVAL FOR THE EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE IN THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO AND INCLUDING 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 4.5 TO 7.5 MM.
P030016|S027|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|VISIAN IMPLANTABLE COLLAMER LENSES|MTA|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/14/2014|12/22/2014|||APPR|APPROVAL TO ADD NEW CALCULATOR SOFTWARE TO THE VISIAN IMPLANTABLE COLLAMER LENS (ICL).
P030002|S031|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENS (IOLS)|MJP|OP|30-Day Notice||N|04/14/2014|05/13/2014|||OK30|ACCEPTANCE OF A MICROBIOLOGICAL TESTING FACILITY AND THE REPURPOSING OF A MANUFACTURING ROOM.
P110019|S067|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|05/13/2014|||OK30|ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.
P070015|S123|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|05/13/2014|||OK30|ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.
P020047|S058|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION CORONARY STENT SYSTEMS, MULTI-LINK MINI VISION CORONARY STENT SYSTEMS, MULTI-LINK 8 CONONARY STENT|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|05/13/2014|||OK30|ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.
P120010|S022|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|05/14/2014|||OK30|ADDITION OF AN AUTOMATED CLEANING SYSTEM FOR COMPONENTS USED IN THE ENLITE SENSOR, WHICH IS A COMPONENT OF THE MINIMED 530G SYSTEM.
N970003|S161|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO AND FORMIO PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|04/29/2014|||OK30|ADD AN ALTERNATE SOURCE SUPPLIER FOR TANTALUM CAPACITORS.
P030005|S108|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE AND INTUA CRT PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|04/29/2014|||OK30|ADD AN ALTERNATE SOURCE SUPPLIER FOR TANTALUM CAPACITORS.
P980006|S022|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/14/2014|07/11/2014|||APPR|APPROVAL FOR THE ADDITION OF THE FOLLOWING PRIVATE LABEL TRADE NAMES: EQUATE MONTHLY SINGLE VISION (BALAFILCON A) CONTACT LENS, EQUATE MONTHLY MULTI-FOCAL (BALAFILCON A) CONTACT LENS, EQUATE MONTHLY TORIC (BALAFILCON A) CONTACT LENSES, AND C-VUE ADDVANTAGE MULTIFOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE EQUATE MONTHLY SINGLE VISION (BALAFILCON A) CONTACT LENS AND IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BYTHE EYE CARE PROFESSIONAL.  THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS OR LESS, THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +8.00D TO -20.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO -20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS.FOR FURTHER INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
P970020|S080|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ULTRA CORONARY STENT SYSTEMS, MULTI-LINK ZETA CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|05/13/2014|||OK30|ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.
P910023|S333|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2014|05/25/2014|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650.
P030054|S265|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2014|05/29/2014|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650.
P030035|S120|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2014|05/29/2014|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650.
P970013|S058|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2014|05/29/2014|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650.
P880086|S242|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2014|05/29/2014|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650.
P880006|S088|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2014|05/29/2014|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650.
P980007|S034|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2014|05/16/2014|||OK30|REVISION OF THE QUALITY CONTROL TEST METHOD TO ALLOW THE AXSYM TOTAL AND FREE PSA TEST METHODS TO BE REPLACED BY THE ARCHITECT TOTAL AND FREE PSA TEST METHODS FOR THE MANUFACTURE OF PSA PANEL H.
P910007|S043|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice||N|04/16/2014|05/16/2014|||OK30|REVISION OF THE QUALITY CONTROL TEST METHOD TO ALLOW THE AXSYM TOTAL AND FREE PSA TEST METHODS TO BE REPLACED BY THE ARCHITECT TOTAL AND FREE PSA TEST METHODS FOR THE MANUFACTURE OF PSA PANEL H.
P910001|S071|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 & CVX-300P EXCIMER LASER SYSTEM|LPC|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2014|06/30/2014|||APPR|APPROVAL FOR THE ADDITION OF FINGER GASKETS TO THE SIDE RADIATIONSHIELDS.
P850068|S010|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, extended wear|SILSOFT (CLASTOFILCON A) CONTACT L ENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2014|05/14/2014|||OK30|ACCEPTANCE OF AN ALTERNATE AUTOCLAVE.
P860057|S124|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDFIAL AORTIC BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2014|05/13/2014|||OK30|UPGRADE OF THE VALVE FLOW AND LEAFLET COAPTATION TESTER.
P010032|S079|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PROTEGE NEUROSTIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/15/2014|07/14/2014|||APPR|APPROVAL FOR RAPID PROGRAMMER VERSION 3.6 TO SUPPORT THEPROGRAMMING OF THE PROTÉGÉ NEUROSTIMULATION DEVICES (MODEL 3789 PROTÉGÉ IMPLANTABLE PULSE GENERATOR AND MODEL 3852 PATIENT PROGRAMMER) AS WELL AS TO MAKE MINOR SUSTAINING ENHANCEMENTS.
P110010|S082|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2014|05/12/2014|||OK30|UPGRADE TO THE CURRENT INTEGRATED CRIMP AND CONE PUFF (ICCP) MACHINES SUCH THAT FUNCTIONALITIES ASSOCIATED WITH THE NON-CONTACT MEASUREMENT SYSTEM (NCMS) WILL BE COMBINED WITH THE ICCP ON ONE MACHINE.
P940015|S032|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2014|05/14/2014|||OK30|ADDITION OF AN AUTOMATED SYSTEM.
P010013|S055|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice||N|04/15/2014|05/14/2014|||OK30|CHANGE IN THE LEAK TEST PERFORMED ON THE RF CONTROLLER MANIFOLD SUBASSEMBLY.
P850068|S011|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, extended wear|SILSOFT(ELASTOFILCON A) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2014|05/08/2014|||OK30|REPLACEMENT OF THE LASER ETCHING SYSTEM.
P100021|S035|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT AND ENDURANT II STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2014|05/13/2014|||APPR|APPROVAL FOR CLARIFICATIONS MADE TO THE REAR HANDLE ASSEMBLY MANUFACTURING PROCESS PROCEDURES.
P100021|S036|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT AND ENDURANT II STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2014|05/14/2014|||APPR|APPROVAL FOR MINOR CLARIFICATIONS TO THE HYDROPHILIC COATING PROCEDURES.
P110014|S003|DUNE MEDICAL DEVICES INC|111 SPEEN ST SUITE 101||FRAMINGHAM|MA|01701||Diagnostic low electric field|MARGINPROBE SYSTEM|OEE|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2014|09/24/2014|||APPR|APPROVAL FOR THE MODIFICATION MADE TO THE MARGINPROBE CONSOLE FROMMARGINPROBE TYPE 1.1 TO MARGINPROBE TYPE 1.2.
P060040|S035|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2014|05/06/2014|||OK30|ADDITION OF A SUPPLIER FOR THE SINTERING PROCESS FOR THE HEARTMATE II LVAS COMPONENTS.
P120005|S019|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/16/2014|07/11/2014|||APPR|APPROVAL FOR A CHANGE TO THE TRANSMITTER THAT COMBINES THE COMPONENTS FROM TWO PRINTED CIRCUIT BOARD ASSEMBLIES (PCBAS) INTO A SINGLE BOARD TRANSMITTER (SBT) WITH ONE PRINTED CIRCUIT BOARD (PCB).
P830055|S143|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2014|05/23/2014|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING PROCESS FOR THE DISTAL AND POSTERIOR AUGMENTS AND THE REVISION STEP WEDGES THAT PROVIDES ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH OR RELIABILITY OF THE DEVICE.
P020036|S028|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|CORDIS SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2014|05/12/2014|||OK30|CHANGE IN MANUFACTURING FACILITY FOR THE SUPPLIER OF THE SLIDER ASSEMBLY AND HANDLE AND THE INTRODUCTION OF A NEW MOLDING MACHINE.
P120002|S003|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|CORDIS SMART CONTROL VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2014|05/12/2014|||OK30|CHANGE IN MANUFACTURING FACILITY FOR THE SUPPLIER OF THE SLIDER ASSEMBLY AND HANDLE AND THE INTRODUCTION OF A NEW MOLDING MACHINE.
P100046|S004|ATRICURE INC.|386 WEST MAIN STREET, SUITE 7||NORTHBOROUGH|MA|01532||Surgical cardiac ablation device, for treatment of atrial fibrillation|ATRICURE SYNERGY ABLATION SYSTEM|OCM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/15/2014|06/13/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P000020|S017|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|BARD ABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2014|06/04/2014|||APPR|APPROVAL FOR IMPLEMENTATION OF A CHANGE TO LEAD-FREE SOLDER IN THECONNECTOR COMPONENT OF THE STINGER AND SCORPION2 ABLATION CATHETERS.
P120006|S013|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2014|12/18/2014|||APPR|APPROVAL TO CHANGE THE MANUFACTURING PROCESS FOR THE IPSILATERAL TAB ON THE AORTIC BODY STENT GRAFT FROM MANUAL TO AUTOMATED.
P100041|S053|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2014|05/16/2014|||OK30|CHANGES TO THE MANUFACTURING FIXTURES USED IN THE MANUFACTURING OF THE RETROFLEX 3 DELIVERY SYSTEM.
P930039|S107|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD|NVN|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/17/2014|10/13/2014|||APPR|APPROVAL FOR ADDING THE 5076 CAPSUREFIX NOVUS LEAD TO THE MR CONDITIONALPACING FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 AND IS INDICATED FOR USE AS A SYSTEM CONSISTING OF A MEDTRONIC MRI SURESCAN IPG IMPLANTED WITH SURESCAN LEADS. A COMPLETE SYSTEM IS REQUIRED FOR USE IN THEMRI ENVIRONMENT.
P110021|S040|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2014|05/16/2014|||OK30|CHANGES TO THE MANUFACTURING FIXTURES USED IN THE MANUFACTURING OF THE RETROFLEX 3 DELIVERY SYSTEM.
P970051|S119|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS CI500 SERIES COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2014|05/16/2014|||OK30|ACCEPTANCE OF A NEW SURGICAL INSTRUMENT SUPPLIER.
P100042|S002|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2014|04/29/2014|||APPR|APPROVAL FOR THE MINOR SOFTWARE CHANGES FOR THE APTIMA HPV ASSAY SOFTWARE (V2.3.5), THE APTIMA HPV-GT ASSAY SOFTWARE (V2.7.5), PANTHER SYSTEM SOFTWARE (V5.2).
P120007|S002|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV 16 18/45 GENETYPE ASSAY|OYB|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|04/17/2014|04/29/2014|||APPR|APPROVAL FOR THE MINOR SOFTWARE CHANGES FOR THE APTIMA HPV ASSAY SOFTWARE (V2.3.5), THE APTIMA HPV-GT ASSAY SOFTWARE (V2.7.5), PANTHER SYSTEM SOFTWARE (V5.2).
P000020|S018|Boston Scientific Corp.|55 TECHNOLOGY DRIVE||LOWELL|MA|01851||Cardiac ablation percutaneous catheter|BARD ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2014|05/16/2014|||OK30|ACCEPTANCE TO IMPLEMENT AN ADDITIONAL SUPPLIER TO PERFORM MACHINING OF THE ABLATION CATHETER HANDLE COMPONENTS.
P980007|S035|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2014|05/13/2014|||OK30|CHANGES TO QUALITY CONTROL TESTING USED ON IN- PROCESS MATERIALS-ARCHITECT FREE PSA BULK SECONDARY CALIBRATORS AND ARCHITECT FREE PSA BULK PRODUCT CALIBRATORS/CONTROLS.
P030011|S025|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)|LOZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/18/2014|06/20/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100009|S004|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM|NKM|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/18/2014|07/09/2014|||APPR|APPROVAL FOR A NEW PATIENT BROCHURE.
P980016|S481|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PROTECTA ICD & PROTECTA XT ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2014|06/20/2014|||APPR|APPROVAL FOR AN UPDATED VERSION OF THE PROTECTA SOFTWARE, MODEL SW009 USED ON THE 2090 PROGRAMMER AND ENCORE PROGRAMMER MODEL 29901 FOR THE DEVICES.
P010031|S443|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROTECTA CRT-D &  PROTECTA XT CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2014|06/20/2014|||APPR|APPROVAL FOR AN UPDATED VERSION OF THE PROTECTA SOFTWARE, MODEL SW009 USED ON THE 2090 PROGRAMMER AND ENCORE PROGRAMMER MODEL 29901 FOR THE DEVICES.
P130016|S003|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/18/2014|09/12/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P130016|S004|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/18/2014|09/11/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960058|S109|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/2014|04/14/2015|||APPR|APPROVAL FOR A LABELING/PACKAGING CHANGE TO THE HIRES 90K ADVANTAGE IMPLANT WITH HIFOCUS MID-SCALA ELECTRODE (HFMS) ELECTRODE (MODEL NUMBER CI-1500-04) AND FOR THE INTRODUCTION OF A REUSABLE INSTRUMENT KIT (MODEL NUMBER CI-4508).
P110035|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2014|05/14/2014|||OK30|CHANGES TO THE ETHYLENE OXIDE STERILIZATION PROCESS.
P910023|S334|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2014|05/19/2014|||OK30|CHANGE TO THE INTEGRATED CIRCUIT COMPONENT REWORK PROCEDURE.
P030054|S266|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA, UNIFY, UNIFY ASSURA, AND UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2014|05/19/2014|||OK30|CHANGE TO THE INTEGRATED CIRCUIT COMPONENT REWORK PROCEDURE.
P970004|S172|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/2014|10/17/2014|||APPR|APPROVAL FOR CHANGES TO THE MODEL 3037 ICON PATIENT CONTROLLER USED FOR MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL.
P080025|S068|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY FOR BOWEL CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/21/2014|10/17/2014|||APPR|APPROVAL FOR CHANGES TO THE MODEL 3037 ICON PATIENT CONTROLLER USED FOR MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL.
P000029|S077|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2014|05/21/2014|||OK30|EXPANSION OF THE  FIRMS CLEAN ROOM PRODUCTION AREA.
P110019|S068|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2014|07/03/2014|||APPR|APPROVAL TO CHANGE THE OUTER LAYER THICKNESS SPECIFICATION FOR THE INNER MEMBER CATHETER COMPONENT FOR THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT OVER THE WIRE (OTW) SYSTEM.
P990004|S024|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATINE SPONGE, USP|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|07/02/2014|||APPR|APPROVAL FOR A MANUFACTURING (PACKAGING) SITE LOCATED AT FERROSAN MEDICAL DEVICES, KOKSOWA, POLAND.
P010012|S351|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INVIVE AND INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/12/2014|||OK30|ADDING AN ALTERNATE OSCILLATOR CRYSTAL COMPONENT TO HYBRID BILL OF MATERIALS FOR THE DEVICES.
N970003|S162|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO AND FORMIO IMPLANTABLE PULSE GENERATOR (PG)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/12/2014|||OK30|ADDING AN ALTERNATE OSCILLATOR CRYSTAL COMPONENT TO HYBRID BILL OF MATERIALS FOR THE DEVICES.
P960004|S065|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P960006|S042|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND PACING LEADS AND FIXATION TOOL|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P940008|S031|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P940031|S077|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P930035|S026|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 AICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P080012|S020|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/22/2014|||OK30|ALTERNATE ELECTRONIC MODULES RANDOM ACCESS MEMORY (RAM).
P020045|S053|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CRYOCONSOLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/14/2014|||OK30|CHANGE TO THE TYPE OF TEST CATHETER USED DURING CRYOCONSOLE MANUFACTURING AND FIELD INSTALLATION TESTING.
P910077|S142|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P910073|S125|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK TRANSVENOUS DEFIBRILLATION SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P830060|S079|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P010012|S352|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2014|05/07/2014|||OK30|ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
P110010|S083|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/22/2014|07/18/2014|||APPR|APPROVAL FOR THE EXTENSION OF THE SHELF LIFE FROM 12 MONTHS TO 18 MONTHS.
P970031|S045|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2014|05/19/2014|||OK30|ADDITION OF NEW PORCINE TISSUE SUPPLIERS.
P990064|S054|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2014|05/19/2014|||OK30|ADDITION OF NEW PORCINE TISSUE SUPPLIERS.
P980043|S045|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2014|05/19/2014|||OK30|ADDITION OF NEW PORCINE TISSUE SUPPLIERS.
P100023|S097|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATNIUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2014|05/22/2014|||OK30|CHANGE TO USE A COLOR CAMERA FOR THE DISTAL TIP INSPECTION PROCESS.
P870078|S025|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2014|05/19/2014|||OK30|ADDITION OF NEW PORCINE TISSUE SUPPLIERS.
P790007|S041|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2014|05/19/2014|||OK30|ADDITION OF NEW PORCINE TISSUE SUPPLIERS.
P110010|S084|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice||N|04/23/2014|05/22/2014|||OK30|CHANGE TO USE A COLOR CAMERA FOR THE DISTAL TIP INSPECTION PROCESS.
P980049|S097|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable cardioverter defibrillator (non-CRT)|PARADYM VR ICD, DR ICD, RF VR ICD, RD DR ICD, ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/23/2014|06/27/2014|||APPR|APPROVAL FOR EMBEDDED SOFTWARE CHANGES FOR THE DEVICES AND A REVISION TO THE ORCHESTRA/ORCHESTRA PLUS SOFTWARE PROGRAMMING MODULE.
P100044|S016|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2014|05/23/2014|||OK30|ADDITION OF A NEW POUCH SEALING EQUIPMENT, SENCORP WHITE HEAT SEALER WITH VACCUUM AND GAS PURGE MODEL 12-PV/2, TO THE EXISTING MANUFACTURING LINE FOR THE PACKAGING OF THE PROPEL AND PROPEL MINI SINUS IMPLANTS.
P010033|S024|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON TB GOLD IN-TUBE|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2014|05/22/2014|||OK30|CHANGE TO THE LOCATION OF MANUFACTURING ACTIVITIES WITHIN THE SAME PREVIOUSLY APPROVED ESTABLISHMENT FOR THE CONTRACT MANUFACTURING ORGANIZATION.
P060027|S064|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D & PARADYM RF CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/23/2014|06/27/2014|||APPR|APPROVAL FOR EMBEDDED SOFTWARE CHANGES FOR THE DEVICES AND A REVISION TO THE ORCHESTRA/ORCHESTRA PLUS SOFTWARE PROGRAMMING MODULE.
P980035|S374|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2014|03/19/2015|||APPR|APPROVAL FOR THE ADVISA SR MRI A3SR01 IMPLANTABLE PULSE GENERATOR IN COMBINATION WITH THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI TO BE MARKETED AS THE ADVISA SR MRI SURESCAN. IN ADDITION YOU REQUESTED APPROVAL FOR MODIFICATIONS TO THE ADVISA SR MRI AND ADVISA DR MRI SOFTWARE APPLICATION MODEL 9995.
P110035|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/24/2014|09/17/2014|||APPR|APPROVAL FOR A MODIFICATION TO THE ELECTROPOLISHING FINISHING OPERATION FOR THE EPIC¿ VASCULAR SELF-EXPANDING STENT SYSTEM.
P980049|S098|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Implantable cardioverter defibrillator (non-CRT)|PARADYM RF VR 9250, VR9250, PARADYM RF DR 9550|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2014|06/27/2014|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES.
P060027|S065|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF CRT-D9750|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2014|06/27/2014|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES.
P110035|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2014|05/23/2014|||OK30|RELOCATION OF THE MANUFACTURING FOR THE E-TUBE COMPONENT FROM ONE BOSTON SCIENTIFIC CORPORATION FACILITY TO ANOTHER.
P980035|S375|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2014|05/15/2014|||OK30|ANTENNA WIRE BOND COAT MANUFACTURING STANDARDIZATION FOR THE DEVICES.
P090013|S140|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2014|05/15/2014|||OK30|ANTENNA WIRE BOND COAT MANUFACTURING STANDARDIZATION FOR THE DEVICES.
P940019|S044|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT ILIAC ENDOPROSTHESIS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2014|05/23/2014|||OK30|RELOCATION OF THE MANUFACTURING FOR THE E-TUBE COMPONENT FROM ONE BOSTON SCIENTIFIC CORPORATION FACILITY TO ANOTHER.
P930031|S052|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2014|05/23/2014|||OK30|RELOCATION OF THE MANUFACTURING FOR THE E-TUBE COMPONENT FROM ONE BOSTON SCIENTIFIC CORPORATION FACILITY TO ANOTHER.
P980033|S041|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2014|05/23/2014|||OK30|RELOCATION OF THE MANUFACTURING FOR THE E-TUBE COMPONENT FROM ONE BOSTON SCIENTIFIC CORPORATION FACILITY TO ANOTHER.
P840001|S268|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS IMPLAMTABLE RESTORE FAMILY|LGW|NE|30-Day Notice||N|04/25/2014|05/23/2014|||OK30|UPDATE THE SOFTWARE USED AT THE MEDTRONIC TEMPE CAMPUS.
P030009|S078|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY RX & OTW CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice||N|04/25/2014|05/23/2014|||OK30|CHANGE TO THE STENT SUB-ASSEMBLY MANUFACTURING EQUIPMENT.
P110013|S040|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY RX & OTW ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|04/25/2014|05/23/2014|||OK30|CHANGE TO THE STENT SUB-ASSEMBLY MANUFACTURING EQUIPMENT.
P100021|S037|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANTSTENT GRAFT SYSTEM; ENDURANT II STENT GRAFT SYSTEM; ENDURANT II AOTO-UNI-LIAC (AUI) STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2014|05/23/2014|||OK30|RELOCATION OF A SECOND TIER SUPPLIER OF A CRITICAL COMPONENT.
P960009|S194|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY|MHY|NE|30-Day Notice||N|04/25/2014|05/23/2014|||OK30|UPDATE THE SOFTWARE USED AT THE MEDTRONIC TEMPE CAMPUS.
P890055|S055|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/22/2014|||APPR|APPROVAL FOR CHANGES TO QUALITY CONTROL AND MANUFACTURING PROCEDURES TO INCLUDE ADDITIONAL STEPS VERIFYING THAT A MINIMUM OF 66 HOURS HAVE ELAPSED BETWEEN THE TIME THAT THE MEDSTREAM PUMP BATTERY IS CONNECTED TO THE PRINTED CIRCUIT BOARD (PCB) AND BEFORE PROGRAMMING THE PCB WITH THE PRODUCTION DIAGNOSTIC PUMP SOFTWARE.
P080012|S021|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/2014|02/10/2015|||APPR|APPROVAL FOR A NEW PROGRAMMER DEVICE. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM AND IS INDICATED FOR INTRATHECAL INFUSION OF INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE) OR PRESERVATIVE-FREE STERILE 0.9% SALINE SOLUTION (SODIUM CHLORIDE INJECTION, USP).
P970003|S170|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|02/12/2016|||APPR|Approval for a manufacturing site located at Cyberonics Latam S.L.R., Edificio B49, 51 Ave 0, Zona Franca Coyol, Coyol - Alajuela, Costa Rica facility, in which the site will perform the final assembly, packaging, storing, and distribution of the Implantable Pulse Generators and the Lead Finals.
P960011|S025|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/27/2014|||OK30|USE OF A NEW INTERMEDIATE VESSEL FOR BVI 1% AND EUFLEXXA OVD.
P010029|S020|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/27/2014|||OK30|USE OF A NEW INTERMEDIATE VESSEL FOR BVI 1% AND EUFLEXXA OVD.
P020004|S094|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/28/2014|||OK30|NEW SUPPLIER FOR BIOLOGICAL INDICATORS.
P040027|S033|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/28/2014|||OK30|NEW SUPPLIER FOR BIOLOGICAL INDICATORS.
P040037|S063|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN EDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/28/2014|||OK30|NEW SUPPLIER FOR BIOLOGICAL INDICATORS.
P130006|S003|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/28/2014|||OK30|NEW SUPPLIER FOR BIOLOGICAL INDICATORS.
P980022|S156|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK REAL-TIME TRANSMITTER, IPRO2  RECORDER|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|10/02/2014|||APPR|APPROVAL FOR A CHANGE TO REPLACE THE CURRENT HOLDER (BLUE TEST PLUG)USED AS A PRODUCTION AID DURING SUB-ASSEMBLY MANUFACTURING OF THE MINILINK (MMT-7703) ANDIPRO2 (MMT-7741) TRANSMITTERS TO TWO NEW HOLDERS. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINKREAL-TIME AND MINIMED 530G SYSTEMS. THE IPRO2 TRANSMITTER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM.
P120010|S023|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINILINK REAL-TIME TRANSMITTER|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|10/02/2014|||APPR|APPROVAL FOR A CHANGE TO REPLACE THE CURRENT HOLDER (BLUE TEST PLUG)USED AS A PRODUCTION AID DURING SUB-ASSEMBLY MANUFACTURING OF THE MINILINK (MMT-7703) ANDIPRO2 (MMT-7741) TRANSMITTERS TO TWO NEW HOLDERS. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINKREAL-TIME AND MINIMED 530G SYSTEMS. THE IPRO2 TRANSMITTER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM.
P090012|S004|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|10/22/2015|||APPR|APPROVAL FOR A CHANGE IN THE CART HIGH POTENTIAL (HI-POT) BREAKDOWN TEST SEQUENCE AND THE RELEASE OF HAND-HELD IMAGER HI-POT BREAKDOWN TEST PROCEDURE.
P090012|S005|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|12/19/2014|||APPR|APPROVAL FOR A DETAILED REVIEW OF THE DATA SUPPORTING THE TRANSFER OF RESPONSIBILITY OF INTEGRATION OF THE SYSTEM FROM MELA SCIENCES MANUFACTURING TO A CONTRACT MANUFACTURER.
P040043|S061|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/28/2014|||OK30|NEW SUPPLIER FOR BIOLOGICAL INDICATORS.
P050006|S038|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|05/28/2014|||OK30|NEW SUPPLIER FOR BIOLOGICAL INDICATORS.
P110010|S085|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLINUS-ELTING PLATINUM CHROMINUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|10/10/2014|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.
P100023|S098|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|10/10/2014|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.
P040016|S129|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|10/10/2014|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.
P020009|S123|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE)|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|10/10/2014|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.
P060006|S060|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|10/10/2014|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.
P090003|S032|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2014|10/10/2014|||APPR|APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.
P890057|S022|CareFusion|75 NORTH FAIRWAY DRIVE||VERNON HILLS|IL|60061||VENTILATOR, HIGH FREQUENCY|3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)|LSZ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|06/02/2014|||OK30|CHANGE TO THE DIAPHRAGM CAP ASSEMBLY.
P050038|S022|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT AND FLEXTIP APPLICATORS|LMG|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|09/24/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAVOL, INC., IN WOBURN, MASSACHUSETTS.
P090012|S006|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|01/12/2016|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGES TO THE TOLERANCES IN THE COMPUTER MOUNT AND SWITCH BRACKET;2) RELOCATION OF MOUNTING HOLES ON THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) PRINTED CIRCUIT BOARD (PCB); 3) OPTIMIZATION OF POWER SUPPLY CAPACITORS AND ADDITION OF RESISTOR VALUES TO TEST SET; AND; 3) CHANGES TO COMPUTER LED INDICATOR AND ASSOCIATED WIRING.
P090012|S007|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|11/26/2014|||APPR|APPROVAL FOR THE CHANGES LISTED BELOW:1) INITIAL RELEASE OF USB 2.0 FOR HAND-HELD IMAGER; 2) REDESIGNED CARD READER ASSEMBLY; 3) RELEASED ACCESSORY KIT WITH DIGITAL CAMERA; 4) HIGH CAPACITY CARD OPTION ADDED; AND 5) MODIFIED PHANTOM FIXTURE MECHANICAL TOLERANCES.
P090012|S008|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|01/26/2015|||APPR|APPROVAL FOR CHANGES TO THE TEST PROCEDURES FOR THE HAND HELD CART ASSEMBLY; DEPLOYMENT OF NEW SOFTWARE AND INSTALLATION WORKSTATIONS AND AN UPDATE FOR THE HAND HELD TEST METHOD.
P090012|S009|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2014|07/07/2014|||OK30|ADDED 3RD PARTY OPERATING SYSTEM INSTALLATION SOFTWARE TO VERSION REGISTRY; AND DEPLOYMENT OF NEW SOFTWARE BUILD AND INSTALLATION WORKSTATIONS.
P830055|S144|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|05/28/2014|||APPR|APPROVAL FOR THE STERILIZATION SITE BE ADDED AT SYNERGY HEALTH WESTPORT LTD., IN MAYO, IRELAND.
P980016|S482|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|05/22/2014|||OK30|UPDATE TO THE NEXT GENERATION HYBRID TESTER PROCESS.
P910023|S335|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|05/23/2014|||OK30|USE OF AN ALTERNATE ELECTROLYTE SUPPLIER FOR THE HIGH VOLTAGE CAPACITORS USED IN THE DEVICES.
P030054|S267|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUANDRA FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|05/23/2014|||OK30|USE OF AN ALTERNATE ELECTROLYTE SUPPLIER FOR THE HIGH VOLTAGE CAPACITORS USED IN THE DEVICES.
P010031|S444|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|05/22/2014|||OK30|UPDATE TO THE NEXT GENERATION HYBRID TESTER PROCESS.
P070026|S022|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|05/28/2014|||APPR|APPROVAL FOR THE STERILIZATION SITE BE ADDED AT SYNERGY HEALTH WESTPORT LTD., IN MAYO, IRELAND.
P920047|S070|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD, BLAZER PRIME HTD|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|05/30/2014|||OK30|ACCEPTANCE TO REPLACE AN EXISTING MANUAL PROCESS WITH AN AUTOMATED PROCESS.
P110019|S069|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION/ XIENCE XPEDITION SV/ XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|09/26/2014|||APPR|APPROVAL FOR A CHANGE TO THE STENT PROCESS MONITORING AND SAMPLING PLAN.
P020025|S058|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|05/30/2014|||OK30|ACCEPTANCE TO REPLACE AN EXISTING MANUAL PROCESS WITH AN AUTOMATED PROCESS.
P960016|S046|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|04/09/2015|||APPR|APPROVAL FOR A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS.
P040014|S023|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|04/09/2015|||APPR|APPROVAL FOR A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS.
P040042|S028|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CATHETER|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|04/09/2015|||APPR|APPROVAL FOR A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS.
P060019|S028|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|04/09/2015|||APPR|APPROVAL FOR A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS.
P110016|S012|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|THERAPY COOL PATH DUO CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2014|04/09/2015|||APPR|APPROVAL FOR A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS.
P910007|S044|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/28/2014|||OK30|CHANGES TO THE QUALITY CONTROL TESTING USED TO ASSESS THE SUITABILITY OF IN-PROCESS ARCHITECT TOTAL PSA BULK SECONDARY CALIBRATOR MATERIALS AND ARCHITECT FREE PSA BULK PRODUCT CALIBRATOR/ CONTROL MATERIALS.
P130016|S005|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2014|11/12/2014|||APPR|APPROVAL FOR CP900 SERIES SOUND PROCESSOR FIRMWARE FEATURES AS PART OF THE NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM. THESE FEATURES INCLUDE A WIND NOISE REDUCTION (WNR) ALGORITHM, A SIGNAL-TO-NOISE RATIO-BASED NOISE REDUCTION (SNR-NR) FUNCTION, AND AN AUTOMATIC ENVIRONMENTAL CLASSIFIER (SCAN) FUNCTION.
P080020|S007|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/30/2014|||OK30|ADDITION OF TWO NEW RAW MATERIAL STORAGE ROOMS.
P050047|S037|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|09/11/2014|||APPR|APPROVAL FOR MOVING BIOBURDEN TESTING, CONDUCTED AS PART OF ROUTINE QUALITY CONTROL PROCEDURES FOR JUVÉDERM HYALURONATE GEL IMPLANTS AND JUVÉDERM VOLUMA XC, FROM A CONTRACT LABORATORY TO IN-HOUSE.
P930016|S040|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|WAVESCAN WAVEFRONT SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/30/2014|||OK30|CHANGE OF THE FRAME GRABBER PRINTED CIRCUIT BOARD (PCB) OF THE STAR SYSTEM.
P910062|S004|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IM EXCIMER LASER SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/30/2014|||OK30|CHANGE OF THE FRAME GRABBER PRINTED CIRCUIT BOARD (PCB) OF THE STAR SYSTEM.
P990010|S004|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR, S41R EXCIMER LASER SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/30/2014|||OK30|CHANGE OF THE FRAME GRABBER PRINTED CIRCUIT BOARD (PCB) OF THE STAR SYSTEM.
P110033|S007|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|09/11/2014|||APPR|APPROVAL FOR MOVING BIOBURDEN TESTING, CONDUCTED AS PART OF ROUTINE QUALITY CONTROL PROCEDURES FOR JUVÉDERM HYALURONATE GEL IMPLANTS AND JUVÉDERM VOLUMA XC, FROM A CONTRACT LABORATORY TO IN-HOUSE.
P100027|S018|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2014|07/30/2014|||APPR|APPROVAL FOR THE EXTENSION OF STABILITY DATING FOR THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL SYSTEM, WHICH INCLUDES THE FOLLOWING PRODUCTS: INFORM HER2 DUAL ISH DNA PROBE COCKTAIL, ULTRAVIEW RED ISH DIG DETECTION KIT, ULTRAVIEW SISH DNP DETECTION KIT.
P070014|S044|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFE STENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/01/2014|07/18/2014|||APPR|APPROVAL FOR A SMALLER STENT DIAMETER (5MM) WITH AN IDENTICAL DESIGN/CUT PATTERN TO THE CURRENT LIFESTENT.
P980044|S018|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/30/2014|||OK30|ADDITION OF TWO NEW RAW MATERIAL STORAGE ROOMS.
P010015|S239|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/29/2014|||OK30|CHANGES TO THE LEAK TEST SYSTEM.
P050033|S016|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/01/2014|07/17/2014|||APPR|APPROVAL FOR CHANGES TO THE STABILITY PROTOCOL.
P890055|S056|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM PROGRAMMABLE INFUSION PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|05/01/2014|07/30/2014|||APPR|APPROVAL TO REPLACE ELECTRICAL GAP WELDING OR LASER WELDING OF THE MEDSTREAM PUMP¿S ELECTRICAL COMPONENTS ON THE PRINTED CIRCUIT BOARD (PCB) WITH A THERMOBRAZING PROCESS, MODIFY THE EXTREMITY OF THE FLEX FLS, FLEX RF, AND BATTERY RIBBON COMPONENT TO INCLUDE APERTURES, AND ELIMINATE THE CURRENT IN-PROCESS MICRO PULL TEST FOR EACH CONNECTION.
P050033|S017|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/22/2014|||OK30|TRANSFER OF RESIDUAL SOLVENT RELEASE TESTING FROM S&N LABORATORIES TO IN-HOUSE TESTING AT ANIKA THERAPEUTICS.
P040024|S073|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L,PERLANE,PERLANE-L,RESTYLANE SILK|LMH|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2014|07/01/2015|15M-2634|07/27/2015|APPR|APPROVAL FOR RESTYLANE LYFT WITH LIDOCAINE. THIS DEVICE IS INDICATED FOR IMPLANTATION INTO THE DEEP DERMIS TO SUPERFICIAL SUBCUTIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL FOLDS AND WRINKLES, SUCH AS NASOLABIAL FOLDS; AND FOR SUBCUTANEOUS TO SUPRAPERIOSTEAL IMPLANTATION FOR CHEEK AUGMENTATION AND CORRECTION OF AGE-RELATED MIDFACE CONTOUR DEFICIENCIES IN PATIENTS OVER THE AGE OF 21.
P980035|S376|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG AND ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/29/2014|||OK30|CHANGES TO THE LEAK TEST SYSTEM.
P090013|S141|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2014|05/29/2014|||OK30|CHANGES TO THE LEAK TEST SYSTEM.
P100009|S005|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM|NKM|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2014|05/22/2014|||APPR|APPROVAL FOR A LABELING CHANGE THAT INCLUDED ADDITIONS TO THE LIST OF ANTICIPATED EVENTS AND CONVERTING CERTAIN PROCEDURAL CAUTION STATEMENTS TO WARNING STATEMENTS.
P040044|S056|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP VASCULAR CLOSURE DEVICE|MGB|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/02/2014|07/30/2014|||APPR|APPROVAL TO EXPAND THE INDICATIONS FOR USE TO INCLUDE CLOSURE OF VENOUS ACCESS SITES IN ADDITION TO THE CURRENTLY APPROVED USE FOR CLOSURE OF ARTERIAL ACCESS SITES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL AND FEMORAL VENOUS ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH.
P060001|S020|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, CAROTID|PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM|NIM|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/02/2014|01/21/2015|15M-0228|01/23/2015|APPR|APPROVAL FOR THE PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO AND INCLUDING 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF7.5 TO 11 MM.
P030022|S030|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC HIP SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2014|05/30/2014|||OK30|INTRODUCE A NEW TRAY SEALER TO THE PACKAGING PROCESS.
P020025|S059|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|MAESTRO 3000 CARDIAC ABLATION SYSTEM|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|10/17/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.
N970003|S163|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO PACEMAKERS, INGENIO PACEMAKERS, VITALIO PACEMAKERS, FORMIO PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2014|05/28/2014|||OK30|USE AN ALTERNATE INSPECTION METHOD AND EQUIPMENT WITH A CORRESPONDING SPECIFICATION CHANGE.
P030005|S109|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CRT PS, INTUA CRT PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2014|05/28/2014|||OK30|USE AN ALTERNATE INSPECTION METHOD AND EQUIPMENT WITH A CORRESPONDING SPECIFICATION CHANGE.
P010012|S353|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-D,ORIGEN CRT-DS,DYNAGEN CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2014|05/28/2014|||OK30|USE AN ALTERNATE INSPECTION METHOD AND EQUIPMENT WITH A CORRESPONDING SPECIFICATION CHANGE.
P000023|S010|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA-EMINENCE AND CONDY LAR PROSTHESIS SYSTEM|LZD|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2014|05/21/2014|||OK30|ADD WATER QUALITY STANDARDS.
P000035|S010|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA-EMIENCE PROSTHESIS SYSTEM|MPI|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2014|05/21/2014|||OK30|ADD WATER QUALITY STANDARDS.
P960040|S314|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA ICDS, TELIGEN ICDS, ENERGEN ICDS, INCEPTA ICDS, ORIGEN ICDS, INOGEN ICDS, DYNAGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2014|05/28/2014|||OK30|USE AN ALTERNATE INSPECTION METHOD AND EQUIPMENT WITH A CORRESPONDING SPECIFICATION CHANGE.
P030017|S196|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|06/04/2014|||OK30|ADD AN ALTERNATE QUALIFIED SUPPLIER FOR THE PRINTED CIRCUIT BOARD.
N970003|S164|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGENIO,ADVANTIO,VITALIO,FORMIO IMPLANTABLE PULSE GENERATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|05/23/2014|||OK30|ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.
P100023|S099|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|06/03/2014|||OK30|CHANGE TO THE HEAT SHRINK REMOVAL PROCESS FOR THE STENT DELIVERY CATHETERS.
P110043|S006|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VACULAR SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2014|05/13/2014|||OK30|ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.
P110010|S087|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS PREMIER & PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|06/03/2014|||OK30|CHANGE TO THE HEAT SHRINK REMOVAL PROCESS FOR THE STENT DELIVERY CATHETERS.
P110042|S033|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL|LWS|CV|30-Day Notice||N|05/05/2014|05/28/2014|||OK30|TRANSFER THE FINAL PACKAGE FOR THE EIT FROM CAMERON TO CAMERONS CONTRACT MANUFACTURER BOSTON SCIENTIFIC CORPORATION (BSC).
P120009|S001|PFM MEDICAL, INC|1815 ASTON AVE|SUITE 106|CARLSBAD|CA|92008||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|NIT-OCCLUD PDA|MAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/05/2014|08/01/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910056|S017|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|EN VISTA ONE PIECE HYDROPHOBIC ACRYLIC LENS|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/05/2014|08/01/2014|||APPR|APPROVAL FOR A PACKAGING CHANGE AND AN EXTENSION OF THE SHELF LIFE OF THE DEVICE IN THE NEW PACKAGING CONFIGURATION FROM 14 TO 36 MONTHS.
P110004|S004|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|06/02/2014|||OK30|SHORTENING OF THE SUPPLY CHAIN FOR THE NYLON 12 RAW MATERIAL USED IN THE COATING OF A COMPONENT OF THE D-CATHETER DELIVERY SYSTEM.
P110004|S005|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|09/11/2014|||APPR|APPROVAL TO INTRODUCE A SEMI-AUTOMATED HYDROPHILIC COATING PROCESS WHILE RETAINING THE MANUAL PROCESS AS AN ALTERNATE OPTION.
P930029|S043|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF MARINR MC/SC /SCXL/ SCXS/SCXXL/, RF CONTACTR, RF CONDUCTR & RF CONDUCTR II CARDIAC ABLATION CATHETERS.|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|05/16/2014|||OK30|CHANGE TO THE PROCESS CONTROLS ON THE PART OF A SUPPLIER TO VERIFY INSULATION BETWEEN THERMOCOUPLE DOUBLE WIRES.
P040013|S019|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Bone grafting material, dental, with biologic component|GEM 21S GROWTH FACTOR ENHANCE MATRIX|NPZ|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|10/21/2014|||APPR|APPROVAL FOR A NEW FILTRATION STEP AND RENOVATIONS AT THE SHIRLEY, NEW YORK MANUFACTURING FACILITY.
P110004|S006|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORNARY STENT ON RX|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|06/04/2014|||OK30|ELIMINATING A REDUNDANT INSPECTION STEP AND REMOVING AN UNNECESSARY LABELING STEP.
P030005|S110|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE, INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-PS)|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|05/23/2014|||OK30|ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.
P960040|S315|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN,INOGEN,ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|05/23/2014|||OK30|ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.
P010012|S354|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN,INOGEN,ORIGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|05/23/2014|||OK30|ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.
P920047|S071|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|10/17/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.
P980003|S050|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|10/17/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.
P110010|S086|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2014|06/04/2014|||OK30|REMOVE THE MANUAL INSPECTION OF THE DISTANCE BETWEEN THE BI-COMPONENT ASSEMBLY (BOND) AND PROXIMAL BALLOON BOND.
P100023|S100|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|05/05/2014|06/04/2014|||OK30|REMOVE THE MANUAL INSPECTION OF THE DISTANCE BETWEEN THE BI-COMPONENT ASSEMBLY (BOND) AND PROXIMAL BALLOON BOND.
P010013|S056|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL SYSTEM WITH SURE|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2014|06/04/2014|||OK30|CHANGE TO UPDATE THE PROCEDURE FOR EXTERNAL SHEATH, CERVICAL COLLAR AND IMD ASSEMBLY.
P020018|S052|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2014|06/04/2014|||APPR|APPROVAL FOR UPDATING YOUR INTERNAL QUALITY CONTROL FOR THE ZENITH AAAENDOVASCULAR GRAFT INTRODUCTION SYSTEM SUBASSEMBLIES BY ADDING AN ADDITIONAL INSPECTION STEP TO CHECK FOR SECURITY OF THE TAPERED TIP ON THE CANNULA.
P030017|S197|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2014|06/06/2014|||OK30|CHANGE TO THE SUPPLIERS FACILITY LOCATION.
P110028|S012|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2014|10/03/2014|||APPR|APPROVAL FOR A CHANGE IN THE STENT EXPANSION PROCESS FOR THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM.
N970003|S140|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGENIO (MODELS K172, K173, K174) AND ADVANTIO (MODELS K062, K063 AND K 064) PACEMAKERS|LWP|CV|||N|09/14/2012|03/12/2013|||APPR|APPROVAL FOR THE INVIVE MODELS V172, V173.
P010030|S050|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFE VEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2014|06/06/2014|||OK30|CHANGE TO THE ACCEPTANCE CRITERIA OF REFURBISHED BATTERY PACKS.
P090031|S001|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2014|06/06/2014|||OK30|ADD AN ALTERNATE RAW MATERIAL SUPPLIER.
P110042|S034|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2014|05/29/2014|||OK30|ADD A DROPOUT VOLTAGE VARIATION TEST IN THE MANUFACTURING PROCESS FOR THE S-ICD PULSE GENERATOR.
P980035|S377|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA, IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2014|06/02/2014|||OK30|REPLACE THE EXISTED OVEN WITH A NEW INFRARED CURE OVEN FOR THE DADET CURINGPROCESS AT THE FINAL DEVICE MANUFACTURING FACILITY FOR THE  DEVICES.
P110042|S035|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2014|05/30/2014|||OK30|CHANGES RELATED TO MANUFACTURING PROCESS OF THE BATTERY INCLUDING QUALIFYING A NEW WELD MACHINE, MODIFYING THE INSULATING TAPE USED IN SHIPPING, AND NEW FIXTURES.
P010015|S240|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2014|05/28/2014|||OK30|ADD AN ADDITIONAL ULTRASONIC WELD (USW) TO CONNECT THE CONNECTOR SUB-ASSEMBLY TO THE RADIOPAQUE COMPONENT.
P980016|S483|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD; S VR ICD; EVERA XT DR ICD; XT VR ICD; MAXIMO II ICD; PROTECTA ICD; XT ICD; SECURA ICD; VIRTUOSO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2014|05/30/2014|||OK30|CHANGE IN THE AVX CAPACITOR LAPPING PROCESS USED IN THE DEVICES.
P010031|S445|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D ; CONCERTO II CRT-D; CONSULTA ICD; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT-D; VIVA S CRT-D; XT CRT-||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2014|05/30/2014|||OK30|CHANGE IN THE AVX CAPACITOR LAPPING PROCESS USED IN THE DEVICES.
P960040|S316|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TELIGEN, PROGENY ICD AND NG ICD MODELS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/09/2014|07/16/2014|||APPR|APPROVAL FOR MODEL 2868 APPLICATION SOFTWARE VERSION 3.04 AND FIRMWARE VERSION A_V1.04 WITH PATCH V4.01 AND FIRMWARE VERSION B_V1.02 WITH PATCH V3.01 FOR THE DEVICES.
P040002|S047|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2014|12/31/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
P010012|S355|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|COGNIS, PROGENY CRT-D AND NG CRT-D MODELS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/09/2014|07/16/2014|||APPR|APPROVAL FOR MODEL 2868 APPLICATION SOFTWARE VERSION 3.04 AND FIRMWARE VERSION A_V1.04 WITH PATCH V4.01 AND FIRMWARE VERSION B_V1.02 WITH PATCH V3.01 FOR THE DEVICES.
P020036|S029|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|CORDIS SMART CONTROL NITINOL STENT SYSTEMS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|06/13/2014|||OK30|IMPLEMENTATION OF A NEW ULTRASONIC WELDER TO BE USED BY THE SUPPLIER OF THE HEMOSTASIS VALVE OF THE SLIDER ASSEMBLY.
P120002|S004|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|SMART CONTROL VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|06/13/2014|||OK30|IMPLEMENTATION OF A NEW ULTRASONIC WELDER TO BE USED BY THE SUPPLIER OF THE HEMOSTASIS VALVE OF THE SLIDER ASSEMBLY.
P130008|S001|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATOR|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|06/09/2014|||OK30|ADDITIONAL ASSEMBLY PROCESS BE ADDED.
P860004|S205|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2014|02/25/2015|||APPR|APPROVAL FOR SYNCHROMED II INFUSION SYSTEM REFILL KIT MODEL 8555AND ISOMED INFUSION SYSTEM REFILL KIT MODELS 8555 AND 8553.
P010012|S356|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEN NG3 CARDIAC RESYNCHRONIZATION THERAPY DEFUBRILLATION DEFIBRILLATOR (CRT-D)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|06/02/2014|||OK30|MODIFY THE PLASMA CLEAN PROCESS.
P960040|S317|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN, INOGEN,DYNAGEN, NG3 IMPLANTABLE CARDIOVESTER DEFIBRILLATOR (ICD) ORIGEN, INOGEN, DYNAGEN NG2.5 IMPLANTABLE CARDI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|06/02/2014|||OK30|MODIFY THE PLASMA CLEAN PROCESS.
P990034|S031|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC ISOMED INFUSION SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2014|02/25/2015|||APPR|APPROVAL FOR SYNCHROMED II INFUSION SYSTEM REFILL KIT MODEL 8555AND ISOMED INFUSION SYSTEM REFILL KIT MODELS 8555 AND 8553.
P090022|S022|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2014|06/16/2014|||APPR|APPROVAL TO REDUCE THE SIZE OF THE SECONDARY PACKAGING WHICH HOUSES THE POUCHED INTRAOCULAR LENSES, LABEL AND DIRECTIONS FOR USE (DFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD, SOFTEC I, AND SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATON CATARACT REMOVAL INADULTS OVER THE AGE OF 21.
P080025|S069|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|EXTERNAL NEUROSTIMULATOR|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|06/10/2014|||OK30|ACCEPTANCE OF MANUFACTURING CHANGES/PROCESS CHANGES AT TWO LOCATIONS INTENDED TO IMPROVE THE MANUFACTURING PROCESSES TO INCREASE THE ASSURANCE THAT THE MODEL 3531VERIFY ENS AND THE MODEL 3537 CONTROLLER WILL PERFORM AS EXPECTED.
P110038|S005|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|06/11/2014|||OK30|ALTERNATE SUPPLIER FOR FABRIC PROCESSING.
P010030|S051|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2014|07/14/2014|||APPR|APPROVAL FOR A SOFTWARE CHANGE THAT WILL ENABLE ANANALOG CLIPPING NOISE DETECTOR WHICH WILL ALLOW THE SYSTEM TO BETTER RECOGNIZE WHEN AN INPUT SIGNAL MAY BE COMPROMISED DUE TO SATURATION OF ANALOG AMPLIFIERS IN THE ECG SIGNAL PROCESSING CIRCUITRY.
P860004|S206|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/12/2014|10/20/2014|||APPR|APPROVAL FOR CHANGES TO THE MODEL 8835 MYPTM USED WITH THE MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM.
P030017|S198|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2014|08/06/2014|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE APPLICATION SPECIFIC INTEGRATED CIRCUIT (ASIC) ON THE BALL GRID ARRAY (BGA) COMPONENT.
P930039|S108|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE FIX NOVUS LEAD. VITATRON CRYSTALLINE  ACTICE FIXATION LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|05/28/2014|||OK30|TIP GRINDING PROCESS IMPROVEMENT FOR HELIX COMPONENTS.
P970004|S173|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|NEUROSTIMULATOR (ENS)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|06/10/2014|||OK30|ACCEPTANCE OF MANUFACTURING CHANGES/PROCESS CHANGES AT TWO LOCATIONS INTENDED TO IMPROVE THE MANUFACTURING PROCESSES TO INCREASE THE ASSURANCE THAT THE MODEL 3531VERIFY ENS AND THE MODEL 3537 CONTROLLER WILL PERFORM AS EXPECTED.
P090013|S142|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2014|05/28/2014|||OK30|TIP GRINDING PROCESS IMPROVEMENT FOR HELIX COMPONENTS.
P110033|S008|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2014|06/10/2014|||OK30|CHANGE TO THE UNIT OF MEASUREMENT FOR GEL TO BE MIXED AND A CHANGE TO THE IN PROCESS CONCENTRATION OF THE LIDOCAINE SOLUTION MIXED INTO THE GEL DURING HOMOGENIZATION.
P100047|S042|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2014|06/11/2014|||OK30|UPDATE TO THE WELDING PROCESS AT HARDING ENERGY, INC FOR THE NICKEL METAL HYDRIDE BATTERY USED IN THE DEVICE CONTROLLER.
P070014|S045|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFE STENT VASCULAR STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/12/2014|07/11/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100047|S043|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2014|06/13/2014|||OK30|CORRECTIONS TO SPECIFIC TEST SCRIPTS RUN BY THE BATTERY TEST EQUIPMENT.
P040033|S025|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING SYSTEM|NXT|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/14/2014|08/12/2014|||APPR|APPROVAL FOR AN ADDITION TO THE LABELING FOR THE BIRMINGHAM HIPRESURFACING (BHR) SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.
P000040|S032|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2014|06/10/2014|||OK30|QUALIFY AN ALTERNATE SECONDARY SUPPLIER OF THE TACKIFIER RESINS USED IN THE PRODUCTION OF THE COATINGS USED ON SHEATH AND CASSETTE TRAY TYVEK LIDS.
P030017|S199|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2014|06/06/2014|||OK30|ALTERNATE QUALIFIED SUPPLIER FOR MIXING THE TWO-PART EPOXY.
N16837|S014|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/11/2014|08/15/2014|||APPR|APPROVAL FOR REMOVAL OF THE ARTEGRAFT CULTURE TUBE INJECTION BLOW MOLD TRANSFER BEAD.
P030019|S019|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC, HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2014|06/12/2014|||OK30|CHANGES TO THE QUALITY CONTROL METHOD.
P060022|S019|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2014|06/12/2014|||OK30|ADDITION OF A GETINGE STEAM STERILIZER FOR THE STERILIZATION OF AKREOS INTRAOCULAR LENSES.
P100049|S009|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2014|06/11/2014|||OK30|INTRODUCTION OF NEW TENSILE TESTERS TO BE USED DURING LINX DEVICE MANUFACTURING.
P830055|S145|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2014|06/05/2014|||OK30|INTRODUCE A NEW VACUUM SEALER.
P060027|S066|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INTENSIA CRT-D|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/2014|11/04/2014|||APPR|APPROVAL FOR THE INTENSIA ICD AND CRT-D DEVICES.
P980049|S099|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|INSTENSIA ICD|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/15/2014|11/04/2014|||APPR|APPROVAL FOR THE INTENSIA ICD AND CRT-D DEVICES.
P970051|S120|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2014|06/17/2014|||OK30|ACCEPTANCE OF ALTERNATE SOLDER MATERIAL.
P130016|S006|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2014|06/17/2014|||OK30|ACCEPTANCE OF ALTERNATE SOLDER MATERIAL.
P060038|S020|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/16/2014|07/15/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020012|S009|SUNEVA MEDICAL, INC.|5879 PACIFIC CENTER BLVD.||SAN DIEGO|CA|92121||Implant, dermal, for aesthetic use|BELLAFILL|LMH|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/16/2014|12/23/2014|14M-2376|12/30/2014|APPR|APPROVAL FOR THE BELLAFILL. THIS DEVICE IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS AND MODERATE TO SEVERE, ATROPHIC, DISTENSIBLE FACIAL ACNE SCARS ON THE CHEEK IN PATIENTS OVER THE AGE OF 21 YEARS.
P100026|S018|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2014|06/18/2014|||OK30|ADD ADDITIONAL TESTING EQUIPMENT.
P810002|S090|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST.JUDE MEDICAL MECHANICAL HEART VALVE, SJM MASTER SERIES MECHANICAL HEART VALVESJM REGENT MECHANICAL HEART VALVE,|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2014|10/07/2014|||APPR|APPROVAL FOR TRANSFER OF A COMPONENT MANUFACTURING PROCESS TO CAGUAS, PUERTO RICO.
P120005|S020|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2014|06/18/2014|||OK30|CHANGE TO INCREASE THE MANUFACTURING SPACE TO SUPPORT NEW CLEANENVIRONMENT AND MATERIAL TRANSFER ROOMS FOR G4 PLATINUM SENSOR/APPLICATORS.
P930016|S042|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2014|05/30/2014|||OK30|ADDITION OF A RE-POLISHING PROCESS FOR THE HEX PRISM ASSEMBLY, OF THE STAR SYSTEM.
P910062|S006|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2014|05/30/2014|||OK30|ADDITION OF A RE-POLISHING PROCESS FOR THE HEX PRISM ASSEMBLY, OF THE STAR SYSTEM.
P990010|S006|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2014|05/30/2014|||OK30|ADDITION OF A RE-POLISHING PROCESS FOR THE HEX PRISM ASSEMBLY, OF THE STAR SYSTEM.
P040037|S064|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2014|06/18/2014|||OK30|ADDITION OF ELEMENTS OF AUTOMATION TO THE EXISTING QUALITY CONTROL TESTING FOR HEPARIN ACTIVITY.
P130006|S004|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2014|06/18/2014|||OK30|ADDITION OF ELEMENTS OF AUTOMATION TO THE EXISTING QUALITY CONTROL TESTING FOR HEPARIN ACTIVITY.
P100005|S004|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|M-VU ALGORITHM ENGINE|MYN|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2014|06/06/2014|||APPR|APPROVAL FOR M-VU® ALGORITHM ENGINE VERSION 3.1.0.0 WITH SHORTER EXECUTION TIME.
P040033|S026|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2014|06/17/2014|||APPR|APPROVAL FOR REVISIONS TO THE DEVICE LABELING.
P050039|S016|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2014|06/18/2014|||OK30|CHANGE IN A QUALITY CONTROL TEST PARAMETER.
P070014|S046|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2014|06/17/2014|||OK30|OPTIONAL PROCESS FOR TRANSFERRING A STENT TO A NEW DELIVERY SYSTEM CATHETER.
P010030|S052|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2014|04/09/2015|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE PRINTED CIRCUIT BOARD (PCB) INTHE LIFEVEST 4000 BATTERY PACK TO ACCOMMODATE AN END-OF-LIFE REPLACEMENT PROTECTOR CIRCUIT IC.
P010013|S057|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2014|06/19/2014|||OK30|MANUFACTURING PROCESS CHANGE TO ADD AN ADDITIONAL ZIG-ZAG STITCH TO THE CURRENT ARRAY LINER AND ARRAY SEWING ASSEMBLY PROCESS.
P030006|S026|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2014|10/24/2014|||APPR|APPROVAL FOR REPLACING THE CURRENT SUPPLIER FOR MANIFOLD TUBING, AND TO REPLACE MEDICAL DEVICE ADHESIVE CURRENTLY USED IN MANUFACTURING.
P040033|S027|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2014|07/30/2014|||APPR|APPROVAL FOR AN INSTRUMENT TO ASSIST IN FEMORAL COMPONENT SIZING AND POSITIONING.
P910023|S336|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FAMILY OF MERLIN@HOME TRANSMITTERS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2014|07/24/2014|||APPR|APPROVAL FOR CYBERSECURITY UPDATES TO THE MERLIN@HOMETRANSMITTERS.
P030054|S268|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FAMILY OF MERLIN@HOME TRANSMITTERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2014|07/24/2014|||APPR|APPROVAL FOR CYBERSECURITY UPDATES TO THE MERLIN@HOMETRANSMITTERS.
P120020|S003|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/22/2014|11/07/2014|||APPR|APPROVAL FOR A CHANGE TO THE COLORS INCLUDED IN THE 6FR AND 7FR DELIVERY SYSTEMS MANUFACTURED AT THE CURRENT SITE IN WEBSTER, TEXAS.
P100046|S005|ATRICURE INC.|386 WEST MAIN STREET, SUITE 7||NORTHBOROUGH|MA|01532||Surgical cardiac ablation device, for treatment of atrial fibrillation|ATRICURE SYNERGY ABLATION SYSTEM|OCM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2014|10/22/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, MILPITAS, CALIFORNIA.
P060040|S036|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/21/2014|07/27/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE BACKUP APPLICATION OF THE POCKET CONTROLLER.
P930039|S109|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2014|06/17/2014|||OK30|MINOR CHANGE TO THE PLASMA TREATMENT AND SPOOLING PROCESS USED ON SILICONE TUBING WHICH IS USED AS INSULATION IN THE IMPACTED LEAD MODEL.
P970004|S174|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|VERIFY EVALUATION SYSTEM;FOR INTERSTIM THERAPY FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2014|06/19/2014|||OK30|ACCEPTANCE OF TWO MANUFACTURING CHANGES/PROCESS CHANGES TO THE MODEL 3537CONTROLLER.
P080025|S070|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR BOWEL CONTROL; VERIFY CONTROLLER|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2014|06/19/2014|||OK30|ACCEPTANCE OF TWO MANUFACTURING CHANGES/PROCESS CHANGES TO THE MODEL 3537CONTROLLER.
P050037|S049|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/19/2014|||OK30|CHANGES TO THE ASSEMBLY PROCESS FOR THE SYRINGES USED WITH THE RADIESSE DERMAL FILLER.
P050052|S054|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/19/2014|||OK30|CHANGES TO THE ASSEMBLY PROCESS FOR THE SYRINGES USED WITH THE RADIESSE DERMAL FILLER.
P010012|S357|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/17/2014|||OK30|ADD THE MODEL SE600 SOLDER PRINT INSPECTION (SPI) SYSTEM AS PART OF THE MANUFACTURE PROCESS FOR THE DEVICES.
P960040|S318|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEN|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/17/2014|||OK30|ADD THE MODEL SE600 SOLDER PRINT INSPECTION (SPI) SYSTEM AS PART OF THE MANUFACTURE PROCESS FOR THE DEVICES.
P020004|S095|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/18/2014|||OK30|IMPLEMENTATION OF AN AUTO-TWIST FEATURE TO THE CONSTRAINING LOOP MANUFACTURING PROCESS.
P860057|S125|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/18/2014|||OK30|EXPANSION OF A CLEAN ROOM AT THE EDWARDS SINGAPORE MANUFACTURING FACILITY AND THE ADDITION OF ASSOCIATED EQUIPMENT FOR USE IN THE EXISTING CLEAN ROOM.
P980035|S378|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DRIPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/17/2014|||OK30|IMPROVEMENTS FOR THE PLASMA CLEANING PROCESS AT THE MANUFACTURING SITE AT MEDTRONIC PUERTO RICO OPERATIONS (MPROC) FOR THE DEVICES.
P010031|S446|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCETO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/17/2014|||OK30|IMPROVEMENTS FOR THE PLASMA CLEANING PROCESS AT THE MANUFACTURING SITE AT MEDTRONIC PUERTO RICO OPERATIONS (MPROC) FOR THE DEVICES.
P860057|S126|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2014|08/11/2014|||APPR|APPROVAL FOR A RECONFIGURATION OF VALVE STENTS, WIREFORMS, AND LEAFLET ASSEMBLIES, AS WELL AS MODIFICATIONS TO THE LABELING.
P040036|S043|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL|LPB|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/23/2014|08/01/2014|||APPR|APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE OF THE POST APPROVAL STUDY RESULTS ON THE NAVISTAR THERMOCOOL CATHETER FOR VT CONDITION.
P090018|S026|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2014|08/21/2014|||APPR|APPROVAL FOR SOFTWARE CHANGES THAT HAVE BEEN MADE TO THE ESTEEMCOMMANDER IN VERSION 3.0.
P130015|S001|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/06/2014|||OK30|CHANGES TO THE IN-PROCESS TEST PROCEDURE FOR THE BULK POSITIVE CONTROL AND TO THE MANUFACTURING PROCESS FOR FILLING OF THE STREPTAVIDIN COATED BEADS.
P040047|S035|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/19/2014|||OK30|CHANGES TO THE ASSEMBLY PROCESS FOR THE SYRINGES USED FOR THE COAPTITE INJECTABLE IMPLANT.
P090013|S143|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/17/2014|||OK30|IMPROVEMENTS FOR THE PLASMA CLEANING PROCESS AT THE MANUFACTURING SITE AT MEDTRONIC PUERTO RICO OPERATIONS (MPROC) FOR THE DEVICES.
P020004|S096|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/20/2014|||OK30|NEW TEMPERATURE CONTROL UNITS ON EXISTING MOLDING MACHINES FOR CATHETER COMPONENTS.
P980016|S484|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, VR ICD, XT DR ICDXT VR ICD, MAXIMO II ICD PROTECTA ICD, XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/17/2014|||OK30|IMPROVEMENTS FOR THE PLASMA CLEANING PROCESS AT THE MANUFACTURING SITE AT MEDTRONIC PUERTO RICO OPERATIONS (MPROC) FOR THE DEVICES.
P040043|S062|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/20/2014|||OK30|NEW TEMPERATURE CONTROL UNITS ON EXISTING MOLDING MACHINES FOR CATHETER COMPONENTS.
P040037|S065|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/20/2014|||OK30|NEW TEMPERATURE CONTROL UNITS ON EXISTING MOLDING MACHINES FOR CATHETER COMPONENTS.
P130006|S005|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2014|06/20/2014|||OK30|NEW TEMPERATURE CONTROL UNITS ON EXISTING MOLDING MACHINES FOR CATHETER COMPONENTS.
P040044|S057|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX ACE VASCULAR CLOSURE DEVICE|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2014|08/18/2014|||APPR|APPROVAL FOR A MODIFIED PACKAGING TRAY, REMOVAL OF THE GUIDEWIRE AND J-STRAIGHTENER, AND UPDATED IFU TO REMOVE REFERENCES TO THE PROVIDED GUIDEWIRE AND J-STRAIGHTENER.
P010030|S053|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/27/2014|11/06/2015|||APPR|APPROVAL FOR THE LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.  THE DEVICE AS MODIFIED IS APPROVED FOR 1) CHANGE TO THE LENGTH OF THE THERAPY ELECTRODE CHANNEL FOAM; 2) CHANGE TO THE DIMENSIONAL TOLERANCES OF THE HOLE LOCATIONS ON THE THERAPY ELECTRODELIDDING LAYER;3) CHANGE FROM ADHESIVE TO CRIMPING OF THE BATTERY CONNECTOR AND REINFORCEMENT OF THE BATTERY CELLS WITHIN THE WCD 4000 PACK; AND4) CHANGE OF MATERIAL OF THE HEX NUT USED IN THE WCD 4000 MONITOR ELECTRODE BELTRECEPTACLE FROM BRASS TO STAINLESS STEEL.
P110033|S009|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC,JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2014|06/24/2014|||OK30|IMPLEMENTATION OF A NEW INCOMING WAREHOUSE AND A COLD ROOM FOR THE STORAGE OF RAW MATERIALS AND PACKAGING ITEMS.
P120020|S004|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2014|07/10/2014|||APPR|APPROVAL FOR IMPLEMENTATION OF A SEMI-AUTOMATED PASSIVATION PROCESS AND A CHANGE TO THE PASSIVATION OF STENT COUPLINGS BY AN ALTERNATE VENDOR.
P050047|S038|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS, JUVEDERN VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2014|06/24/2014|||OK30|IMPLEMENTATION OF A NEW INCOMING WAREHOUSE AND A COLD ROOM FOR THE STORAGE OF RAW MATERIALS AND PACKAGING ITEMS.
P910077|S143|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/27/2014|07/16/2014|||APPR|APPROVAL FOR THE WAVE COMMUNICATOR MODEL 6280 SW VERSION V1.52.00;WAVE COMMUNICATOR MODEL 6290 SW VERSION V2.02.00;WAVE COMMUNICATOR MODEL 6498 SW VERSION V1.52.00;LATITUDE NXT SYSTEM SOFTWARE MODEL 6460 V.3.00.01; ANDCOMMUNICATOR ACCESSORY AND LITERATURE KIT MODEL 6250.
P100014|S013|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA  INJECTABLE GEL|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2014|02/12/2015|||APPR|APPROVAL FOR AN EXTENSION OF THE CLEAN ROOM USED DURING THE MANUFACTURE OF SOLESTA.
P040024|S074|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, PERLANE, RESTYLANE L, PERLANE L|LMH|SU|30-Day Notice||N|05/28/2014|06/25/2014|||OK30|INTRODUCTION OF A SECOND SUPPLIER FOR READY PREPARED SOLUTIONS USED IN THE MANUFACTURE OF THE RESTYLANE INJECTABLE GELS.
P080009|S002|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/28/2014|10/07/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910023|S337|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT+, FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2014|06/25/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE IDENTICAL EPOXY USED IN THE MANUFACTURE OF THE DEVICES.
P030054|S269|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE+,UNIFY,UNIFY ASSURA,UNIFY QUADRA, & QUADRA ASSURA CRT-DS|NIK|CV|30-Day Notice||N|05/28/2014|06/25/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE IDENTICAL EPOXY USED IN THE MANUFACTURE OF THE DEVICES.
P880086|S243|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT, VERITY, IDENTITY, ZEPHYR, ASSURITY/+, ENDURITY CRT-P'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2014|06/25/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE IDENTICAL EPOXY USED IN THE MANUFACTURE OF THE DEVICES.
P970013|S059|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY CRT-P'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2014|06/25/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE IDENTICAL EPOXY USED IN THE MANUFACTURE OF THE DEVICES.
P030035|S121|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM AND ALLURE CRT-P'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2014|06/25/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE IDENTICAL EPOXY USED IN THE MANUFACTURE OF THE DEVICES.
P080009|S003|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Normal 180 Day Track No User Fee||N|05/28/2014|11/03/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100047|S044|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/29/2014|06/27/2014|||APPR|APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE INFORMATION RELATED TO BATTERY PERFORMANCE.
P010023|S011|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM|MPV|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/29/2014|05/04/2015|||APPR|APPROVAL FOR CHANGING THE UNAIDED AIR CONDUCTION THRESHOLD UPPER LIMITS TO 60, 70, AND 85 DB HL AT FREQUENCIES OF 250, 500, AND 1000 HZ, RESPECTIVELY, AND TO 100 DB HL AT 2000, 3000, 4000, AND 6000 HZ AS PART OF THE PATIENT SELECTION CRITERIA.
P100047|S045|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/29/2014|06/29/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100047|S046|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/29/2014|09/25/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010032|S080|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|OCTRODE LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2014|06/27/2014|||OK30|IMPLEMENT CHANGES TO THE TESTING AND INSPECTION PROCESS.
P840001|S269|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE BATTERY.
P010014|S048|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/2014|07/07/2014|||APPR|APPROVAL TO UPDATE THREE CONTRAINDICATIONS IN THE INSTRUCTIONS FOR USE FOR THE OXFORD® PARTIAL KNEE SYSTEM.
P860004|S207|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|DRUG DELIVERY INFUSION|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE BATTERY.
P980016|S485|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD , EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/18/2014|||OK30|UPDATE TO THE EQUIPMENT SOFTWARE FOR THE CASE-TO-COVER (CTC) LASER WELD PROCESS.
P010031|S447|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/18/2014|||OK30|UPDATE TO THE EQUIPMENT SOFTWARE FOR THE CASE-TO-COVER (CTC) LASER WELD PROCESS.
P800002|S021|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBIBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR, 1G SYRINGE, ENDO AVIETENE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/26/2014|||OK30|FOIL POUCH SUPPLIER FACILITY SITE CHANGE AND THE PROPOSED REMOVAL OF A REJECTION CRITERION FOR COMPONENT ACCEPTANCE IN AN IN-PROCESS INSPECTION STEP FOR THE AVITENE PRODUCT FAMILY.
N17600|S029|DAVOL, INC., SUB. C.R. BARD, INC.|100 Crossings Boulevard||Warwick|RI|02886||Agent, absorbable hemostatic, collagen based|AVITENE MICROFIBBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR 1 G SYRINGE, ENDO AVITENE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/26/2014|||OK30|FOIL POUCH SUPPLIER FACILITY SITE CHANGE AND THE PROPOSED REMOVAL OF A REJECTION CRITERION FOR COMPONENT ACCEPTANCE IN AN IN-PROCESS INSPECTION STEP FOR THE AVITENE PRODUCT FAMILY.
P960009|S195|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE BATTERY.
P950037|S134|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|VARIOUS MODELS OF SLX LEADS AND VARIOUS MODELS OF SELOX,DEXTRUS,AND SAFIO DRUG ELUTING LEADS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/30/2014|||OK30|COROX, CELERITY LEADS
P970004|S175|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE BATTERY.
P980023|S058|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/30/2014|||OK30|COROX, CELERITY LEADS
P080025|S071|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE BATTERY.
P070008|S051|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VARIOUS MODELS OF COROX, CELERITY AND LV LEADS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/30/2014|||OK30|COROX, CELERITY LEADS
P020056|S025|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|02/11/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRO-TECH DESIGN AND MANUFACTURING, INC., IN ARLINGTON, TEXAS.
P040046|S007|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|02/11/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRO-TECH DESIGN AND MANUFACTURING, INC., IN ARLINGTON, TEXAS.
P990074|S029|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE FILLED BREST IMPLANTS|FWM|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|02/11/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRO-TECH DESIGN AND MANUFACTURING, INC., IN ARLINGTON, TEXAS.
P910023|S338|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FORTIFY AND FORTIFY ASSURA ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/18/2014|||OK30|ADD A VISUAL INSPECTION STEP FOR THE MANUFACTURE PROCESS OF THE DEVICES.
P030054|S270|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY, UNIFY ASSURA, UNIFY QUADRA, AND QUADRA ASSURA CRT-DS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/30/2014|06/18/2014|||OK30|ADD A VISUAL INSPECTION STEP FOR THE MANUFACTURE PROCESS OF THE DEVICES.
P100034|S010|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|OPTUNE|NZK|NE|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/30/2014|09/28/2014|||APPR|APPROVAL FOR A TRADE NAME CHANGE FROM THE NOVOTTF-100A SYSTEM TO OPTUNE¿.  YOU HAVE ALSO REQUESTED THAT THE COMPONENTS OF THE NOVOTTF-100A SYSTEM (A PLUGIN POWER SUPPLY; CHARGER FOR PORTABLE BATTERIES; DEVICE & BATTERY CARRYING BAG; PORTABLE BATTERY; AND, CONNECTION CABLE & BOX), ALONG WITH THE TRANSDUCER ARRAY AND ELECTRIC FIELD GENERATOR (THE DEVICE), BE NAMED THE OPTUNE¿ TREATMENT KIT.
P840001|S270|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORESENSOR RECHARGEABLE NEUROSTIMULATOR; RESTORESENSOR SURESCAN MRI RECHARGEABLE NEUROSTIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|07/02/2014|||OK30|UPDATE TO THE PROCESS FLOW AT THE IC SUPPLIER.
P010047|S035|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|07/02/2014|||OK30|ALTERNATE EXTENDED APPLICATOR SPRAY TIP SUPPLIER.
P110042|S037|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/27/2014|||OK30|NEW BATTERY FLEX FORMING FIXTURE.
P080025|S072|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS BOWEL VERIFY SCREENING TRAILING SYSTEM (INCLUDING TEMPORATY LEADS)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|07/02/2014|||OK30|UPDATE TO THE PROCESS FLOW AT THE IC SUPPLIER.
P970004|S176|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY VERIFY SCREENING TRAILING SYSTEMS (INCLUDING TEMPORARY LEADS)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|07/02/2014|||OK30|UPDATE TO THE PROCESS FLOW AT THE IC SUPPLIER.
P000046|S024|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/24/2014|||OK30|CHANGE TO THE QUALITY CONTROL METHOD FOR REDUCED TESTING FOR ANIKA¿SOPHTHALMIC DEVICES: STAARVISC, OPTIVISC, NUVISC, AND ANIKAVISC SODIUM HYALURONATE AT THE POSTFILL STAGE.
P020009|S124|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS2 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/30/2014|||OK30|CHANGE TO THE STENT LASER CUTTING AND INSPECTION PROCESS.
P980007|S036|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA (LN 6C07)|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/18/2014|||OK30|CHANGES TO THE QUALITY CONTROL TESTING OF ARCHITECT FREE PSA PANELS G/I, ARCHITECT TOTAL PSA PANEL STOCK AND ARCHITECT TOTAL PSA PANELS K/Q.
P120010|S024|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2014|02/19/2015|||APPR|APPROVAL CHANGES TO THE DESIGN AND MANUFACTURING OF THE NEEDLE FORTHE MEDTRONIC MINIMED 530G SYSTEM ENLITE GLUCOSE SENSOR (MMT-7008A, MMT- 7008B); THE SPECIFICALLY PROPOSED CHANGES WHICH INFLUENCE THE ENLITE NEEDLE TO INTRODUCE A BEVEL AT THE NEEDLE TIP AND INCREASE NEEDLE SHARPNESS.
P910007|S045|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA (LN 6C06)|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/18/2014|||OK30|CHANGES TO THE QUALITY CONTROL TESTING OF ARCHITECT FREE PSA PANELS G/I, ARCHITECT TOTAL PSA PANEL STOCK AND ARCHITECT TOTAL PSA PANELS K/Q.
P040016|S130|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/30/2014|||OK30|CHANGE TO THE STENT LASER CUTTING AND INSPECTION PROCESS.
P980003|S051|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/27/2014|||OK30|CHANGE IN MANUFACTURE OF THE CHILLI II CATHETER WHERE A POWERED BRAID REMOVAL FIXTURE WILL REPLACE THE MANUAL PREPARATION OF THE PROXIMAL SHAFT.
P060006|S061|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/30/2014|||OK30|CHANGE TO THE STENT LASER CUTTING AND INSPECTION PROCESS.
P090003|S033|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/30/2014|||OK30|CHANGE TO THE STENT LASER CUTTING AND INSPECTION PROCESS.
P100023|S101|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/30/2014|||OK30|CHANGE TO THE STENT LASER CUTTING AND INSPECTION PROCESS.
P030017|S200|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|07/11/2014|||OK30|ALTERNATE CAPACITOR SUPPLIER.
P110010|S088|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTINGPLATINUM CHROMIUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2014|06/30/2014|||OK30|CHANGE TO THE STENT LASER CUTTING AND INSPECTION PROCESS.
P030017|S201|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2014|08/28/2014|||APPR|APPROVAL FOR A CHANGE TO THE PRECISION SPECTRA OBSERVATIONALMECHANICAL GATEWAY (OMG) DIRECTIONS FOR USE. THE PROPOSED CHANGE IS TO ADD THE ST JUDE PENTA LEAD (MODEL # 3228) TO THE TABLE OF COMPATIBLE ST. JUDE LEADS IN THE DIRECTIONS FOR USE. IN ADDITION, A STATEMENT WAS ADDED TO THE INTENDED USE SECTION TO REFER TO THE PRECISION SPECTRA SYSTEM MANUALS FOR THE INDICATIONS AND CONTRAINDICATIONS.
P000037|S036|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2014|10/28/2014|||APPR|APPROVAL FOR VERTICAL INTEGRATION OF A COMPONENT SUBSTRATE MANUFACTURING PROCESS.
P100010|S036|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHERTERS|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2014|07/02/2014|||OK30|NEW SUPPLIER, INSPECTION CHANGE, AND MINOR UPDATES TO THE SPECIFICATION OF THE BELLOWS COMPONENT.
P020045|S054|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER; FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2014|07/17/2014|||APPR|MODIFICATIONS TO THE Y-BLOCK DISTAL DIAMETER AND THE ADHESIVE USED IN THE Y-BLOCK TO SHAFT BOND.
P110023|S008|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2014|07/02/2014|||OK30|ALLOW INTERNAL PRODUCTION OF A BRAID COMPONENT FOR THE EVERFLEX OUTER CATHETER.
P120010|S025|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2014|07/02/2014|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) TO ADD A NEW SENSOR FABRICATION CONFIGURATION TO INCLUDEA 48-UP SENSOR MASK. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P980037|S042|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA THOMRBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THOMBRBECTOMY SET, VG THOMRBECTOMY SET, DISTAFLEX THOMBRBECTOM|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2014|09/02/2014|||APPR|APPROVAL FOR A CHANGE TO THE DESIGN AND MANUFACTURING PROCESS OF THEMID-JOINT CONNECTION ON THE ANGIOJET ULTRA THROMBECTOMY SETS.
P020004|S097|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2014|06/30/2014|||OK30|EXPANSION OF THE PROCESS RANGE FOR A CATHETER BOND.
P840001|S271|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL,RESTORE, SYNERGY SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/03/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P110019|S070|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/04/2014|09/03/2014|||APPR|APPROVAL TO CHANGE THE DISTAL BALLOON SHAFT, DISTAL OUTER MEMBER AND PROXIMAL HYPOTUBE COMPONENTS FOR THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM. YOU INDICATED THAT UPON IMPLEMENTATION OF THESE CHANGES, THE NEW NAME FOR THE CORONARY STENT SYSTEM WILL BE THE XIENCE ALPINE¿ EVEROLIMUS ELUTING CORONARY STENT SYSTEM.
P020004|S098|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.
P050006|S039|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice||N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.
P040043|S063|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.
P040037|S066|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice||N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.
P130006|S006|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice||N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.
P860004|S208|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/03/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P040027|S034|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice||N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.
P960009|S196|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA,KINETRA,SOLETRA SYSTEMS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/03/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P970004|S177|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/03/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P020004|S099|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP <61> AND USP <62>.
P990034|S032|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|DRUG DELIVERY CATHETERS, DRUG DELIVERY KITS FOR REVISIONS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/03/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P050006|S040|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP <61> AND USP <62>.
P040043|S064|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP <61> AND USP <62>.
P080025|S073|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/03/2014|||OK30|MANUFACTURING CHANGE ASSOCIATED WITH INCOMING INSPECTION ACTIVITIES.
P040037|S067|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP <61> AND USP <62>.
P130006|S007|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP <61> AND USP <62>.
P040027|S035|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP <61> AND USP <62>.
P020004|S100|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|UPDATED HARDWARE AND SOFTWARE FOR FTIR SPECTROPHOTOMETER COMPUTERS.
P050006|S041|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|UPDATED HARDWARE AND SOFTWARE FOR FTIR SPECTROPHOTOMETER COMPUTERS.
P040043|S065|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|UPDATED HARDWARE AND SOFTWARE FOR FTIR SPECTROPHOTOMETER COMPUTERS.
P040037|S068|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|UPDATED HARDWARE AND SOFTWARE FOR FTIR SPECTROPHOTOMETER COMPUTERS.
P130006|S008|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|UPDATED HARDWARE AND SOFTWARE FOR FTIR SPECTROPHOTOMETER COMPUTERS.
P040027|S036|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|UPDATED HARDWARE AND SOFTWARE FOR FTIR SPECTROPHOTOMETER COMPUTERS.
P020004|S101|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL MOISTURE ANALYZER AND IMPLEMENTATION OF ADDITIONAL FUNCTIONALITY OF THE ANALYZER.
P050006|S042|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL MOISTURE ANALYZER AND IMPLEMENTATION OF ADDITIONAL FUNCTIONALITY OF THE ANALYZER.
P040043|S066|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL MOISTURE ANALYZER AND IMPLEMENTATION OF ADDITIONAL FUNCTIONALITY OF THE ANALYZER.
P040037|S069|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL MOISTURE ANALYZER AND IMPLEMENTATION OF ADDITIONAL FUNCTIONALITY OF THE ANALYZER.
P130006|S009|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL MOISTURE ANALYZER AND IMPLEMENTATION OF ADDITIONAL FUNCTIONALITY OF THE ANALYZER.
P040027|S037|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2014|07/02/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL MOISTURE ANALYZER AND IMPLEMENTATION OF ADDITIONAL FUNCTIONALITY OF THE ANALYZER.
P110023|S009|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2014|07/01/2014|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED STENT CLEANING PROCESS.
P040024|S075|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE/PERLANE,  RESTYLANE-L/PERLANE-L INJECTABLE GELS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2014|07/01/2014|||OK30|INTRODUCTION OF AN INTERMEDIATE STORAGE SYSTEM (ISS) IN THE MANUFACTURING PROCESS USED IN FACTORY 2.
P060001|S021|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, ILIAC|PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2014|07/01/2014|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED STENT CLEANING PROCESS.
P990038|S020|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS ASSAY|LOM|MI|30-Day Notice||N|06/05/2014|06/27/2014|||OK30|CHANGE TO THE IN-PROCESS QC PROCEDURE FOR A RAW MATERIAL.
P990045|S017|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-COREK PLUS ASSAY|LOM|MI|30-Day Notice||N|06/05/2014|06/27/2014|||OK30|CHANGE TO THE IN-PROCESS QC PROCEDURE FOR A RAW MATERIAL.
P990041|S019|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-EBK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2014|06/27/2014|||OK30|CHANGE TO THE IN-PROCESS QC PROCEDURE FOR A RAW MATERIAL.
P990042|S016|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK-PLUS|LOM|MI|30-Day Notice||N|06/05/2014|06/27/2014|||OK30|CHANGE TO THE IN-PROCESS QC PROCEDURE FOR A RAW MATERIAL.
P990043|S020|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-EBK PLUS ASSAY|LOM|MI|30-Day Notice||N|06/05/2014|06/27/2014|||OK30|CHANGE TO THE IN-PROCESS QC PROCEDURE FOR A RAW MATERIAL.
P990044|S017|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-CORE-IGMK PLUS ASSAY|LOM|MI|30-Day Notice||N|06/05/2014|06/27/2014|||OK30|CHANGE TO THE IN-PROCESS QC PROCEDURE FOR A RAW MATERIAL.
P980035|S379|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2014|06/30/2014|||OK30|MINOR CHANGES TO THE BATTERY MANUFACTURING PROCESS.
P080027|S017|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|Real-Time Process||N|06/06/2014|09/02/2014|||APPR|APPROVAL FOR CHANGES TO THE EXPIRATION DATING FOR THE ORAQUICK® HCV VISUAL REFERENCE PANEL TO A FIVE MONTH EXPIRATION DATE FOR POUCHED AND UN-POUCHED DEVICES THAT ARE PROTECTED FROM LIGHT AND 15 DAYS FOR DEVICES THAT ARE NOT PROTECTED FROM LIGHT.
P890003|S310|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2014|06/30/2014|||OK30|MINOR CHANGES TO THE BATTERY MANUFACTURING PROCESS.
P890055|S057|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP ACCESSORIES, MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2014|07/11/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS BELGIUM (PETIT-RECHAIN) S.A. IN VERVIERS, BELGIUM.
P000025|S078|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2014|12/08/2014|||APPR|ADDITIONAL SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P000025|S079|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2014|01/20/2015|||APPR|APPROVAL FOR THE MI1200 SYNCHRONY AND MI1200 SYNCHRONY PINCOCHLEAR IMPLANTS, EACH WITH ELECTRODE VARIANTS +STANDARD, +MEDIUM, +COMPRESSED, GB, +FLEX24, +FLEX28, ASSOCIATED SURGICAL TOOLS, REPLACEMENT IMPLANT MAGNET AND NON-MAGNETIC SPACER, AND COMPATIBLE MAGNETS FOR EXTERNAL COMPONENTS.
P100042|S003|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|30-Day Notice||N|06/09/2014|07/07/2014|||OK30|CHANGE TO REVISE AN INTERNAL CONTROL QC RELEASE TEST SPECIFICATION FOR THE APTIMA® HPV ASSAY.
P920046|S008|FEMCARE LTD.|STUART COURT, SPURSHOLT PLACE, SALISBURY RD|ROMSEY|HAMPSHIRE||SO516||Laparoscopic contraceptive tubal occlusion device|FILSHIE CLIP(MARK VI) SYSTEM|KNH|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2014|12/02/2016|||APPR|Approval for the single use only Sterishot II Applicator.
P910073|S126|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2014|06/30/2014|||OK30|ADD THE MODEL 6946 LEAD REPAIR KIT TO THE LIST OF DEVICES TO BE STERILIZED IN THE G8 #3 STERILIZATION CHAMBER.
P100026|S019|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2014|07/09/2014|||OK30|USE A REPLACEMENT DETERGENT TO CLEAN CERTAIN PARTS.
P030005|S111|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CRT-P, CONTAK RENEWAL TR CRT-P, INTUA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2014|07/08/2014|||OK30|ADD A FUNCTIONALLY EQUIVALENT STERILIZATION CHAMBER; 2) ADD A THIRD ABATOR TO BE USED WITH THE ADDITIONAL STERILIZER; AND 3) INCLUDE STERILIZER CHAMBER ENHANCEMENTS REQUIRED FOR THE EXISTING AND ADDITIONAL STERILIZER CHAMBERS.
P010012|S358|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUCTUA, COGNIS, DYANAGEN, INOGEN, ORIGEN CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2014|07/08/2014|||OK30|ADD A FUNCTIONALLY EQUIVALENT STERILIZATION CHAMBER; 2) ADD A THIRD ABATOR TO BE USED WITH THE ADDITIONAL STERILIZER; AND 3) INCLUDE STERILIZER CHAMBER ENHANCEMENTS REQUIRED FOR THE EXISTING AND ADDITIONAL STERILIZER CHAMBERS.
P960040|S319|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2014|07/08/2014|||OK30|ADD A FUNCTIONALLY EQUIVALENT STERILIZATION CHAMBER; 2) ADD A THIRD ABATOR TO BE USED WITH THE ADDITIONAL STERILIZER; AND 3) INCLUDE STERILIZER CHAMBER ENHANCEMENTS REQUIRED FOR THE EXISTING AND ADDITIONAL STERILIZER CHAMBERS.
N970003|S165|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2014|07/08/2014|||OK30|ADD A FUNCTIONALLY EQUIVALENT STERILIZATION CHAMBER; 2) ADD A THIRD ABATOR TO BE USED WITH THE ADDITIONAL STERILIZER; AND 3) INCLUDE STERILIZER CHAMBER ENHANCEMENTS REQUIRED FOR THE EXISTING AND ADDITIONAL STERILIZER CHAMBERS.
P970051|S121|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2014|09/09/2014|||APPR|APPROVAL FOR CHANGES TO THE FIRMWARE OF THE CP900 SERIES (NUCLEUS 6) SOUND PROCESSOR AND CR200 SERIES REMOTE ASSISTANTS WHICH WILL ALLOW THE USE OF WIRELESS ACCESSORIES.
P100021|S038|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT AND ENDURANT II STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)||N|06/09/2014|07/08/2014|||APPR|APPROVAL FOR INTRODUCING A LAMP MANDREL AS A MANUFACTURING TOOL FOR RADIOPAQUE CONTRALATERAL GATE MARKER INSPECTION OF ENDURANT AND ENDURANT II BIFURCATED STENT GRAFTS AND A COIL DISPENSER AS A VISUAL AID DURING THE PRE-KITTING PROCESS OF ENDURANT II STENT GRAFTS.
P120005|S021|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2014|06/30/2014|||OK30|ADDITION OF WAREHOUSE SPACE.
P910077|S144|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Pacemaker/icd/crt non-implanted components|VENTAK PRX AND VENTAK MINI SYSTEMS|OSR|CV|Real-Time Process||N|06/09/2014|08/12/2014|||APPR|APPROVAL FOR MODEL 2909 MULTIPLE APPLICATION UTILITY SYSTEM SOFTWARE V9.03 AND MODEL 2905 PDF REPORT GENERATION SOFTWARE V1.02 WHICH RESIDE ON THE ZOOM LATITUDE PROGRAMMING SYSTEM MODEL 3120.
P130016|S007|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID SYSTEM|PGQ|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2014|09/09/2014|||APPR|APPROVAL FOR CHANGES TO THE FIRMWARE OF THE CP900 SERIES (NUCLEUS 6) SOUND PROCESSOR AND CR200 SERIES REMOTE ASSISTANTS WHICH WILL ALLOW THE USE OF WIRELESS ACCESSORIES.
P910023|S339|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2014|08/01/2014|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE HIGH VOLTAGE CAPACITORS UTILIZED IN THE DEVICES.
P020025|S060|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|MAESTRO 4000 CARDIAC ABLATION SYSTEM|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2014|12/19/2014|||APPR|APPROVAL FOR DESIGN CHANGES, LABELING CHANGES, AND A MANUFACTURING SITE CHANGE OF THE STERLLARTECH RESEARCH CORPORATION FROM SUNNYVALE, CA TO MILPITAS, CA FORTHE MAESTRO 4000 CARDIAC ABLATION SYSTEM.
P920047|S072|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|MAESTRO 4000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2014|12/19/2014|||APPR|APPROVAL FOR DESIGN CHANGES, LABELING CHANGES, AND A MANUFACTURING SITE CHANGE OF THE STERLLARTECH RESEARCH CORPORATION FROM SUNNYVALE, CA TO MILPITAS, CA FORTHE MAESTRO 4000¿ CARDIAC ABLATION SYSTEM.
P980003|S052|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|MAESTRO 4000 CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/10/2014|12/19/2014|||APPR|APPROVAL FOR DESIGN CHANGES, LABELING CHANGES, AND A MANUFACTURING SITE CHANGE OF THE STERLLARTECH RESEARCH CORPORATION FROM SUNNYVALE, CA TO MILPITAS, CA FORTHE MAESTRO 4000 CARDIAC ABLATION SYSTEM.
P000046|S025|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||AID, SURGICAL, VISCOELASTIC|OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2014|07/08/2014|||OK30|CHANGE TO THE SYRINGE RESIDUAL SOLVENT TESTING FROM A SUPPLIERS CONTRACT LABORATORY TO THE SUPPLIERS IN-HOUSE FACILITY FOR ANIKAS OPHTHALMIC DEVICES.
P030019|S020|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2014|07/08/2014|||OK30|CHANGE TO THE SYRINGE RESIDUAL SOLVENT TESTING FROM A SUPPLIERS CONTRACT LABORATORY TO THE SUPPLIERS IN-HOUSE FACILITY FOR ANIKAS OPHTHALMIC DEVICES.
P090031|S002|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2014|07/08/2014|||OK30|CHANGE TO THE SYRINGE RESIDUAL SOLVENT TESTING FROM A SUPPLIERS CONTRACT LABORATORY TO THE SUPPLIERS IN-HOUSE FACILITY FOR ANIKAS OPHTHALMIC DEVICES.
P010050|S016|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE HBSAG, IMMULITE 2000 HBSAG|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|11/18/2014|||APPR|APPROVAL FOR A CHANGE IN THE MATERIAL USED TO ESTABLISH THE LOT-SPECIFIC FACTOR THAT IS INCORPORATED IN THE CALCULATION OF THE ASSAY CUTOFF.
P050034|S014|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE|NCJ|OP|Real-Time Process||N|06/11/2014|09/12/2014|||APPR|MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS¿ QUAD LUMEN SOFT TIP.
P010030|S054|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2014|11/06/2015|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER OF AN OFF-THE-SHELF SDRAM INTEGRATED CIRCUIT (IC) USED ON THE LIFEVEST® WEARABLE DEFIBRILLATOR MODEL WCD 4000 COMPUTER PRINTED CIRCUIT BOARD ASSEMBLIES (PCA). THE ALTERNATE SUPPLIER IS INTEGRATED SILICON SOLUTIONS INC. (ISSI). THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P010032|S081|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS IPG, EON IPG, EON C IPG, EON MINI IPG, PROTEGE IPG|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/11/2014|09/16/2014|||APPR|APPROVAL FOR A MATERIAL CHANGE TO THE PORT PLUG USED IN THE APPROVED IMPLANTED PULSE GENERATORS (IPG MODELS 3608, 3688, 3716, 3788 AND 3789). THE PORT PLUG IS AN ACCESSORY TO THE IPG USED TO BLOCK TISSUE INGRESS INTO THE IPG HEADER. WHEN IMPLANTING ONLY A SINGLE LEAD IN AN IPG CONTAINING DUAL LEAD PORTS, THE PORT PLUG IS INSERTED INTO THE UNUSED LEAD PORT AND SECURED BY TIGHTENING THE SETSCREW ONTO THE PORT PLUG.
P090018|S027|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Real-Time Process||N|06/12/2014|09/10/2014|||APPR|APPROVAL FOR CHANGES TO CAPACITANCE SPECIFICATIONS FOR THE ESTEEM SENSOR AND DRIVER COMPONENTS, AND THE ESTEEM SYSTEM IS INTENDED TO ALLEVIATE HEARING LOSS INPATIENTS BY REPLICATING THE OSSICULAR CHAIN AND PROVIDING ADDITIONAL GAIN. THE ESTEEM IS INDICATED FOR PATIENTS WITH HEARING LOSS THAT MEET THE FOLLOWING CRITERIA:1) 18 YEARS OF AGE OR OLDER; 2) STABLE BILATERAL SENSORINEURAL HEARING LOSS;3) MODERATE TO SEVERE SENSORINEURAL HEARING LOSS DEFINED BY PURE TONE AVERAGE (PTA);4) UNAIDED SPEECH DISCRIMINATION TEST SCORE GREATER THAN OR EQUAL TO 40%;5) NORMALLY FUNCTIONING EUSTACHIAN TUBE6) NORMAL MIDDLE EAR ANATOMY;7) NORMAL TYMPANIC MEMBRANE;8) ADEQUATE SPACE FOR ESTEEM IMPLANT DETERMINED VIA A HIGH RESOLUTION CT SCAN; AND 9) MINIMUM 30 DAYS OF EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
P100014|S014|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2014|08/28/2014|||APPR|APPROVAL FOR A CHANGE OF THE MANUFACTURER OF NEEDLES THAT ARE SUPPLIED WITH THE SOLESTA DEVICE.
P040002|S051|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2014|07/11/2014|||OK30|ALTERNATE POLYTETRAFLUOROETHYLENE (PTFE) RESIN.
P040002|S052|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASULAR AAA SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2014|07/09/2014|||OK30|ALTERNATE METHOD FOR THE HEAT-SHRINK PROCESS.
P880086|S244|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT SR RF, ACCENT DR RF PACEMAKERS|NVZ|CV|30-Day Notice||N|06/12/2014|07/09/2014|||OK30|MODIFY THE DEVICE POST STERILIZATION TEST (DPST) AT ATE FOR THE RF TELEMETRY OF THE DEVICES.
P040002|S048|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX BIFURCATED STENT GRAFT DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/12/2014|07/14/2014|||APPR|APPROVAL FOR CHANGES TO THE RETRACTION STOP ON THE INNER CORE OF THEAFX BIFURCATED STENT GRAFT DELIVERY SYSTEM.
P030035|S122|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM RFCRT-PS|NIK|CV|30-Day Notice||N|06/12/2014|07/09/2014|||OK30|MODIFY THE DEVICE POST STERILIZATION TEST (DPST) AT ATE FOR THE RF TELEMETRY OF THE DEVICES.
P090026|S011|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM|OYA|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2014|07/07/2014|||OK30|MODIFICATION TO THE QUALITY CONTROL PREFILL AND POSTFILL REAGENT PACK PROCEDURES.
P040002|S049|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM (ACCESSORY STENT GRAFT DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/12/2014|07/30/2014|||APPR|APPROVAL TO MODIFY THE ANCHOR BONDING PROCESS OF THE FRONT TIP SUBASSEMBLY ON THE AFX ACCESSORY STENT GRAFT DELIVERY SYSTEM.
P110042|S038|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2014|04/09/2015|||APPR|APPROVAL FOR CHANGES TO ADD AN ADDITIONAL STERILIZATION FACILITY AND BACK-UP FACILITY AS WELL AS CHANGES IN THE CYCLE PARAMETERS.
P040002|S050|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2014|07/07/2014|||OK30|ALTERNATE SUPPLIER FOR THE LASER WELDING PROCESS FOR THE DELIVERY SYSTEM INNER CORE SUBASSEMBLIES.
P900056|S139|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P990064|S055|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/11/2014|||OK30|ADDITION OF A NEW SEWING MACHINE FOR USE WITH YOUR CLOTH COVER.
P920047|S073|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P980003|S053|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P050047|S039|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM ULTRA, JUVEDERM ULTRA PLUS, JUVEDERM ULTRA  XC, JUVEDERM ULTRA PLUS XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/09/2014|||OK30|REMOVAL OF AN IN-PROCESS CONTROL TEST USED DURING THE MANUFACTURE OF JUVÉDERM HYALURONATE GEL IMPLANTS.
P980040|S048|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||TECNIS OPTIBLUE 1-PIECE IOL||OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/24/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., IN ANASCO, PUERTO RICO.
P120005|S022|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/10/2014|||OK30|CHANGE TO THE CONDITIONING STEP OF MANUFACTURING THE SENSOR WIRE SUBCOMPONENT OF THE G4 SENSOR. THE G4 SENSOR IS A COMPONENT OF THE G4 PLATINUM CONTINUOUSGLUCOSE MONITORING SYSTEM.
P020009|S125|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P020025|S061|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P040016|S131|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P980043|S046|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/11/2014|||OK30|ADDITION OF A NEW SEWING MACHINE FOR USE WITH YOUR CLOTH COVER.
P950037|S135|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|REOCOR S/D EXTERNAL PACEMAKER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/2014|07/16/2014|||APPR|APPROVAL THE REPLACEMENT OF THE STORAGE CAPACITOR FOR THE DEVICE.
P060006|S062|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P100023|S102|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P110010|S089|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|12/08/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
P050037|S050|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|10/24/2014|||APPR|APPROVAL FOR CHANGES TO THE STERILIZATION PROCESS FOR THE RADIESSE DERMAL FILLER.
P050052|S055|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|10/24/2014|||APPR|APPROVAL FOR CHANGES TO THE STERILIZATION PROCESS FOR THE RADIESSE DERMAL FILLER.
P980016|S486|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD AND MAXIMO VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/11/2014|||OK30|SUPPLIER CHANGE AND SPECIFICATION UPDATE TO P(ETFE) USED IN MEDTRONIC CRDM LITHIUM-ORGANIC ELECTROLYTE BATTERIES.
P980035|S380|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/11/2014|||OK30|SUPPLIER CHANGE AND SPECIFICATION UPDATE TO P(ETFE) USED IN MEDTRONIC CRDM LITHIUM-ORGANIC ELECTROLYTE BATTERIES.
P010015|S241|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/11/2014|||OK30|SUPPLIER CHANGE AND SPECIFICATION UPDATE TO P(ETFE) USED IN MEDTRONIC CRDM LITHIUM-ORGANIC ELECTROLYTE BATTERIES.
P010031|S448|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||INSYNCC III MARQUIS ICD, INSYNC MAXIMO ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/11/2014|||OK30|SUPPLIER CHANGE AND SPECIFICATION UPDATE TO P(ETFE) USED IN MEDTRONIC CRDM LITHIUM-ORGANIC ELECTROLYTE BATTERIES.
P910023|S340|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILIES OF ICD DEVICE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/10/2014|||OK30|CHANGE IN THE TEMPERATURE CYCLING RANGE FOR HYBRID ASSEMBLIES.
P090013|S145|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/08/2014|||OK30|ADD A HELIX LINEARITY INSPECTION AT THE FINAL FUNCTIONAL INSPECTION AND A HELIX LINEARITY FIXTURE TO FACILITATE THIS LINEARITY INSPECTION.
P930039|S110|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/08/2014|||OK30|ADD A HELIX LINEARITY INSPECTION AT THE FINAL FUNCTIONAL INSPECTION AND A HELIX LINEARITY FIXTURE TO FACILITATE THIS LINEARITY INSPECTION.
P090013|S144|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2014|07/11/2014|||OK30|SUPPLIER CHANGE AND SPECIFICATION UPDATE TO P(ETFE) USED IN MEDTRONIC CRDM LITHIUM-ORGANIC ELECTROLYTE BATTERIES.
P110012|S006|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT|OWE|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/16/2014|||OK30|MODIFY THE VALIDATED TEST METHOD MDP00644 FRAGMENTED DNA AGAROSE GEL ELECTROPHORESIS OF THE MANUFACTURING PROCESS OF VYSIS ALK BREAK APART FISH PROBE KIT, PATHVYSION HER-2 DNA PROBE KIT AND UROVYSION BLADDER CANCER KIT.
P030052|S015|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|URO VYSION BLADDER CANCER KIT|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/16/2014|||OK30|MODIFY THE VALIDATED TEST METHOD MDP00644 FRAGMENTED DNA AGAROSE GEL ELECTROPHORESIS OF THE MANUFACTURING PROCESS OF VYSIS ALK BREAK APART FISH PROBE KIT, PATHVYSION HER-2 DNA PROBE KIT AND UROVYSION BLADDER CANCER KIT.
P980024|S013|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATH VYSION HER-2 DNA PROBE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/16/2014|||OK30|MODIFY THE VALIDATED TEST METHOD MDP00644 ¿FRAGMENTED DNA AGAROSE GEL ELECTROPHORESIS¿ OF THE MANUFACTURING PROCESS OF VYSIS ALK BREAK APART FISH PROBE KIT, PATHVYSION HER-2 DNA PROBE KIT AND UROVYSION BLADDER CANCER KIT.
P050047|S040|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/2014|04/17/2015|||APPR|APPROVAL FOR A SECOND SUPPLIER OF RAW HYALURONIC ACID.
P020055|S015|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|02/19/2015|||APPR|APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS.
P100027|S019|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|02/19/2015|||APPR|APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS.
P100009|S006|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP  DELIVERY SYSTEM|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/16/2014|||OK30|SECOND SUPPLIER, A CHANGE IN THE HEAT TREATMENT PROCESS AND ESTABLISHMENT OF A DEFINED RANGE OF ACCEPTABLE RAW MATERIAL HARDNESS FOR THE ACTUATOR COUPLER OF THE MITRACLIP CLIP DELIVERY SYSTEM.
P090022|S023|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|THE SOFTEC HD IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/09/2014|||OK30|ADD THREE COMPONENT WASHERS FOR THE USE IN THE FINAL CLEAN AREA AND INSPECTION DEPARTMENT TO REDUCE BIOBURDEN AND ENDOTOXIN OF THE INTRAOCULAR LENSES.
P030054|S271|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, UNIFY ASSURA  AND QUADRA ASSURA FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/10/2014|||OK30|CHANGE IN THE TEMPERATURE CYCLING RANGE FOR HYBRID ASSEMBLIES.
P100047|S047|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/16/2014|09/12/2014|||APPR|APPROVAL FOR ADDING A TORQUE SPECIFICATION TO THE HVAD PUMP DESIGN SPECIFICATION DOCUMENT.
P020025|S062|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLATIP MIFI FILTER MODULE, INTELLATIP MIFI REFERENCE CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/14/2014|||OK30|UPDATE TO THE CURRENT MANUFACTURING EXECUTION SYSTEM (MES).
P120005|S023|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/14/2014|||OK30|CHANGES TO THE SHIPPING AND STORAGE TEMPERATURE RANGE SPECIFICATIONS FOR TWO REAGENTS USED IN THE MANUFACTURE OF THE DEVICE.
P920015|S132|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|07/10/2014|||OK30|MODIFIED TESTING FREQUENCY FOR THE DESTRUCTIVE PULL TEST OF THE DEVICES.
P990081|S030|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2014|02/19/2015|||APPR|APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS.
P110042|S039|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/16/2014|06/27/2014|||APPR|APPROVAL FOR ADDING LANGUAGE IN THE IMPLANT MANUALS OF THE REFERENCED DEVICES WHICH STATES AND CLARIFIES THAT GOOD TISSUE CONTACT WITH THE ELECTRODE AND PULSE GENERATOR IS IMPORTANT FOR OPTIMIZING SENSING AND THERAPY DELIVERY.
P840001|S272|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|VECTRIS SURESCAN MRI LEADS 1X8 SUBCOMPACT & COMBACT, VECTRIS TRIAL SCREENING LEAD 1X8 SUBCOMPACT & COMPACT|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2014|07/17/2014|||OK30|USE ALTERNATE LASERS FOR THE LASER BONDING PROCESS.
P120005|S024|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2014|07/16/2014|||OK30|MANUFACTURING PROCESS CHANGE FOR THE SENSOR LAYER DEPOSITION PROCESS FOR THE G4 PLATINUM SENSOR. THE G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4¿PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
P980016|S487|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II, PROTECTA, PROTECTA  XT, SECURA, & VIRTUOSO II DR/VR ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2014|07/17/2014|||OK30|CHANGE IN THE EPOXY DISPENSE PROCESS FOR THE DEVICES.
P010031|S449|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2014|07/17/2014|||OK30|CHANGE IN THE EPOXY DISPENSE PROCESS FOR THE DEVICES.
P040047|S036|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2014|07/16/2014|||OK30|CHANGES TO THE STERILIZATION PROCESS FOR THE COAPTITE INJECTABLE IMPLANT.
P960040|S320|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD,ORIGEN EL|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2014|08/26/2014|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE TRANSFORMER USED IN THE NG3 FAMILY OF DEVICES.
P080020|S008|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2014|03/29/2016|||APPR|Approval for the use of a newly installed refrigerator.
P010012|S359|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D),DYNAGEN CRT-D,DYNAGEN X4 CRT-D,INOGEN CRT-D,INOGEN X4 CRT-D,|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/17/2014|08/26/2014|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE TRANSFORMER USED IN THE NG3 FAMILY OF DEVICES.
P090012|S010|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/17/2014|03/02/2016|||APPR|Approval for labeling changes.
P980022|S157|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MYSENTRY SYSTEM, MYSENTRY MONITOR, MYSENTRY OUTPOST|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2014|07/18/2014|||OK30|ADDITION OF A FUNCTIONAL TEST DURING MANUFACTURE OF THE MYSENTRY SYSTEM (MMT-9100). THE MYSENTRY SYSTEM (MMT-9100) CONSISTS OF THE MYSENTRY MONITOR (MMT-9101) AND MYSENTRY OUTPOST (MMT-9102) AND IS APPROVED FOR USE WITH THE PARADIGM REALTIME REVEL SYSTEM.
P100026|S020|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/18/2014|09/02/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P110016|S013|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|FLEXABILITY ABLATION CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2014|01/23/2015|||APPR|APPROVAL FOR THE FLEXABILITY ABLATION CATHETER.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLEXABILITY ABLATION CATHETERAND IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND A COMPATIBLE RF CARDIACABLATION GENERATOR. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIACABLATION PROCEDURES (MAPPING STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
P930014|S073|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/16/2014|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P840001|S273|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 4 RESTORE SENSORY SURE SCAN MRT NEURO STIMULATION SYSTEMS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2014|12/05/2014|||APPR|APPROVAL FOR THE CHANGES TO THE PATIENT PROGRAMMER AND PATIENT RECHARGE KIT USED FOR MEDTRONIC SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
P040020|S054|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTOR|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/16/2014|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P110010|S090|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2014|09/17/2014|||APPR|APPROVAL FOR CHANGES TO THE ACCESSORY KIT (REMOVAL OF CLIPIT HYPOTUBE CLIPS, SUBSTITUTION OF FLUSHING NEEDLE MANUFACTURED BY NEW VENDOR, MODIFICATION OF CARRIER TUBE CLIP AND UPDATE TO THE EDFU) AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
P970003|S172|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY LEAD, MODEL 302,VNS THERAPY PERENNIADURA LEAD,MODEL 303,VNS THERAPY PERENNIAFLEX LEAD MODEL 304|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/17/2014|||OK30|AUTOMATE A WELD ANGLE MEASUREMENT PROCESS.
P960009|S197|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION SYSTEM|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2014|12/05/2014|||APPR|APPROVAL FOR THE CHANGES TO THE PATIENT PROGRAMMER AND PATIENT RECHARGE KIT USED FOR MEDTRONIC SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
P010012|S361|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-DS,ORIGEN CRT-DS,INOGEN CRT-DS,DYNAGEN CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/08/2014|||OK30|ADD A REPLACEMENT AUTOMATED OPTICAL (AOI) INSPECTION EQUIPMENT FOR DEVICE IDENTIFICATION AND TORQUE WRENCH VERIFICATION.
P960040|S322|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA ICDS,TELIGEN ICDS,ENERGEN ICDS,INCEPTA ICDS,ORIGEN ICDS,INOGEN ICDS,DYNAGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/08/2014|||OK30|ADD A REPLACEMENT AUTOMATED OPTICAL (AOI) INSPECTION EQUIPMENT FOR DEVICE IDENTIFICATION AND TORQUE WRENCH VERIFICATION.
P960040|S321|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NG3 ICDS, ORIGEN, INOGEN, DYNAGEN  EL; NG2.5 ICDS -ORIGEN, INOGEN, DYNAGEN  MINI ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/11/2014|||OK30|ADD THE LASER ETCHED SCRATCHES INSPECTION CRITERIA FOR THE DEVICES
P010012|S360|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NG3  CRT-D,  DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/11/2014|||OK30|ADD THE LASER ETCHED SCRATCHES INSPECTION CRITERIA FOR THE DEVICES
P100026|S021|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/19/2014|09/03/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980035|S381|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, AND SENSIA IPG'S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/16/2014|||OK30|IMPLEMENTATION OF AN EQUIVALENT STERILIZER AND AERATOR.
P830061|S109|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE BIPOLAR LEAD 4074, CAPSURE SENSE BIPOLAR LEAD 4574|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/16/2014|||OK30|IMPLEMENTATION OF AN EQUIVALENT STERILIZER AND AERATOR.
P090013|S146|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN LEAD 5086MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/16/2014|||OK30|IMPLEMENTATION OF AN EQUIVALENT STERILIZER AND AERATOR.
P930039|S111|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD 4076, CAPSUREFIX NOVUS LEAD 5076|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2014|07/16/2014|||OK30|IMPLEMENTATION OF AN EQUIVALENT STERILIZER AND AERATOR.
P010031|S450|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA  CRT-D; CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D , PROTECTA CRT-D,PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT||CV|30-Day Notice||N|06/20/2014|07/09/2014|||OK30|REDUCTION OF SONOSCAN DETECTION METHOD FOR THE DEVICES.
P980016|S488|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD; EVERA XT DR. ICD; EVERA XT VR IC D; MAXIMO II ICD; PROTECTA ICD' SECURA ICD, VIRTUOSO II|LWS|CV|30-Day Notice||N|06/20/2014|07/09/2014|||OK30|REDUCTION OF SONOSCAN DETECTION METHOD FOR THE DEVICES.
P950029|S091|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2014|07/16/2014|||OK30|CHANGE TO THE IN-PROCESS VERIFICATIONS FOR TANTALUM CAPACITORS USED IN THE DEVICES.
P020002|S008|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP IMAGING SYSTEM|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|06/20/2014|09/18/2014|||APPR|APPROVAL FOR MODIFICATIONS OF THE THINPREP IMAGER DUO IMAGING STATION SOFTWARE.
P010032|S082|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON, EON MINI AND PROTEGE IPG'S|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2014|07/17/2014|||OK30|UPGRADE THE WELDING EQUIPMENT USED IN A MANUFACTURING PROCESS.
P980049|S100|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750, PARADYM DR 8750,PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2014|07/16/2014|||OK30|CHANGE TO THE IN-PROCESS VERIFICATIONS FOR TANTALUM CAPACITORS USED IN THE DEVICES.
P060027|S067|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D (ZL102)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2014|07/16/2014|||OK30|CHANGE TO THE IN-PROCESS VERIFICATIONS FOR TANTALUM CAPACITORS USED IN THE DEVICES.
P980023|S059|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART SD, VIGILA, VOLTA|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/11/2014|||OK30|ADDITIONAL SUPPLIER FOR THE CONDUCTOR WIRES USED IN THE MANUFACTURE OF THE LEADS.
P950037|S136|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SELOX, TILDA, SOLOX|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/11/2014|||OK30|ADDITIONAL SUPPLIER FOR THE CONDUCTOR WIRES USED IN THE MANUFACTURE OF THE LEADS.
P070008|S052|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX, CELERITY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/11/2014|||OK30|ADDITIONAL SUPPLIER FOR THE CONDUCTOR WIRES USED IN THE MANUFACTURE OF THE LEADS.
P950037|S137|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ETRINSA 8/6 DR-T/SR-T, ETRINSA 6 DR/SR, EPYRA 8/6 DR-T/SR-T, ELUNA 8 DR-T/SR-T DR/SR PRO MRI PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/2014|11/17/2014|||APPR|APPROVAL FOR THE ETRINSA, EPYRA AND ELUNA PACEMAKER FAMILIES WITH PROGRAMMER SOFTWARE 1304.U FOR THE RENAMIC PROGRAMMER AND HOME MONITORING SERVICE CENTER WITH SOFTWARE VERSION 3.26.0.
P900033|S037|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/03/2014|||OK30|CHANGE IN THE CLEANING VALIDATION TO EXTEND THE DIRTY HOLD TIME OF TANKS TK-01 AND TK-02 USED IN THE WET PROCESSING FORMULATION.
P100049|S010|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|Special (Immediate Track)||N|06/23/2014|07/22/2014|||APPR|APPROVAL FOR LABELING ALTERATIONS INCLUDING ADVERSE EVENT INFORMATION ABOUT EROSION OF THE LINX DEVICE, CLARIFICATIONS OR CONTRAINDICATIONS REGARDING NICKEL, WARNINGS REGARDING STORAGE AND USE ABOVE 60 DEGREES C, ADDITIONAL POTENTIAL RISK OF SALIVA/MUCUS BUILD-UP, AND DIRECTIONS WHICH ADD THE REMOVAL OF SUTURES AFTER THE CLASP ENDS ARE FULLY ENGAGED.
P020045|S056|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FOCAL CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/09/2014|||OK30|ADDITION OF AN INSPECTION PROCEDURE FOR THE LOW PRESSURE REGULATOR DURING MANUFACTURING, AS WELL AS THE REPLACEMENT OF AN ANALOG PRESSURE GAUGE USED DURING INSTALLATION AND MAINTENANCE WITH A DIGITAL ONE.
P020045|S055|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER, XTRA SURGICAL CRYOABLATION CATHETER, MAX SURGICAL CARDIAC CRYOABLATION CATHETER|LPB|CV|Real-Time Process||N|06/23/2014|08/27/2014|||APPR|APPROVAL FOR UPDATES TO THE BLOOD BOARD AND ELECTRICAL UMBILICAL CABLE.
P100010|S037|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYOABLATION CATHETER|OAE|CV|Real-Time Process||N|06/23/2014|08/27/2014|||APPR|APPROVAL FOR UPDATES TO THE BLOOD BOARD AND ELECTRICAL UMBILICAL CABLE.
P020004|S102|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/21/2014|||OK30|NEW TOOLING USED IN A MOLDING PROCESS, REPLICATION OF THE MOLDING PROCESS ATAN ADDITIONAL FACILITY, AND A NEW SUPPLIER OF THE MOLDED COMPONENT.
P070008|S053|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ETRINSA 8 HF-T, EPYRA 8 HF-T, ELUNA 8 HF-T CRT-P'S|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/2014|11/17/2014|||APPR|APPROVAL FOR THE ETRINSA, EPYRA AND ELUNA PACEMAKER FAMILIES WITH PROGRAMMER SOFTWARE 1304.U FOR THE RENAMIC PROGRAMMER AND HOME MONITORING SERVICE CENTER WITH SOFTWARE VERSION 3.26.0.
P060040|S037|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/17/2014|||OK30|MANUFACTURING PROCESS CHANGES TO THE PRINTED CIRCUIT BOARD (PCB) OF THE DEVICE CONTROLLER.
P050023|S077|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/2014|11/17/2014|||APPR|APPROVAL FOR THE ETRINSA, EPYRA AND ELUNA PACEMAKER FAMILIES WITH PROGRAMMER SOFTWARE 1304.U FOR THE RENAMIC PROGRAMMER AND HOME MONITORING SERVICE CENTER WITH SOFTWARE VERSION 3.26.0.
P000009|S058|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS & LEXOS DR/DR-T/VR/VR-T ICD'S, LUMOS DR-T/VR-T, XELOS DR-T ICD'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/23/2014|11/17/2014|||APPR|APPROVAL FOR THE ETRINSA, EPYRA AND ELUNA PACEMAKER FAMILIES WITH PROGRAMMER SOFTWARE 1304.U FOR THE RENAMIC PROGRAMMER AND HOME MONITORING SERVICE CENTER WITH SOFTWARE VERSION 3.26.0.
P120010|S026|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT|OZO|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/2014|02/04/2015|||APPR|APPROVAL FOR REPLACING THE TEST PLUG WITH TWO WATERTIGHT TESTERS IN THE MINILINK KIT.
P120010|S027|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/24/2014|||OK30|CHANGE IN THE CONCENTRATION OF A RAW MATERIAL USED DURING MANUFACTURE OF THE ENLITETM GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOFTM GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM® REAL-TIME SYSTEM AND PARADIGM® REAL-TIME REVEL SYSTEM.
P980022|S158|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/24/2014|||OK30|CHANGE IN THE CONCENTRATION OF A RAW MATERIAL USED DURING MANUFACTURE OF THE ENLITETM GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOFTM GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM® REAL-TIME SYSTEM AND PARADIGM® REAL-TIME REVEL SYSTEM.
P010012|S362|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2 IS-1 CORONARY VENOUS BIPOLAR PACE/SENSE LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/09/2014|||OK30|EXTEND THE EXPIRATION TERM FOR PLASMA TREATMENT AND TO ADD A PROCESS MONITOR.
P980043|S047|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/23/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P120010|S028|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2014|07/22/2014|||OK30|CHANGE TO THE NEEDLE HUB ASSEMBLY TOOLING WHICH IS USED IN THE MANUFACTURE OF THE ENLITE SENSOR (MMT-7008). THE ENLITE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P790007|S042|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/23/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P920048|S008|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|RAPID FFN CONTROL KIT|LKV|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2014|07/24/2014|||OK30|CHANGE TO ADD AN INTERMEDIATE SOLUTION IN THE MANUFACTURING PROCESS OF POSITIVE REFERENCE CALIBRATOR, TO MODIFY THE PERSONNEL IN CHARGE OF IN-PROCESS MANUFACTURING TESTING AND TO INCREASE THE NUMBER OF REPLICATES IN BULK SOLUTION CONCENTRATION VERIFICATION PROCEDURE FOR BOTH POSITIVE REFERENCE CALIBRATOR AND POSITIVE CONTROL. THE POSITIVE REFERENCECALIBRATOR AND THE POSITIVE CONTROL ARE COMPONENTS OF THE RAPID FFN CONTROL KIT FOR USE WITH THE TLIIQ ANALYZER AND FFN ELISA TEST.
P100010|S038|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|BALLOON CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/09/2014|||OK30|ADDITION OF AN INSPECTION PROCEDURE FOR THE LOW PRESSURE REGULATOR DURING MANUFACTURING, AS WELL AS THE REPLACEMENT OF AN ANALOG PRESSURE GAUGE USED DURING INSTALLATION AND MAINTENANCE WITH A DIGITAL ONE.
P020045|S057|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/2014|08/07/2014|||APPR|APPROVAL FOR MINOR LABELING CHANGES FOR THE FREEZOR FAMILY OF DEVICES.
P100010|S039|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYOABLATION CATHETER|OAE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/2014|08/07/2014|||APPR|APPROVAL FOR MINOR LABELING CHANGES FOR THE FREEZOR FAMILY OF DEVICES.
P100010|S040|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARTIC FRONT CYROABLATION CATHETER, ARTIC FRONT ADVANCE CRYOABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2014|07/25/2014|||OK30|ALTERNATE SUPPLIER FOR CONNECTORS AND CONNECTOR FITTINGS AND ACCEPTANCE OF AN ALTERNATE ADHESIVE CURING PROCESS.
P970031|S046|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/23/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P990064|S056|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/23/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P870078|S026|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2014|07/23/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P060006|S063|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2014|07/18/2014|||OK30|CHANGE IN THE MANUAL INSPECTION OF A COMPONENT WELD TO A SEMI-AUTOMATED INSPECTION.
P900056|S140|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2014|07/24/2014|||OK30|CHANGE TO THE DEVICE COMPONENT QUALITY INSPECTION PROCESS.
P030019|S021|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2014|07/25/2014|||OK30|CHANGES IN THE MANUFACTURING EQUIPMENT.
P130009|S001|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2014|08/04/2014|||OK30|MODIFY THE SAMPLING PLAN FOR ROUTINE MONITORING OF THE EDWARDS BALLOON CATHETER, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, NOVAFLEX+ DELIVERY SYSTEM AND ASCENDRA+ DELIVERY SYSTEM.
P100041|S054|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2014|08/04/2014|||OK30|MODIFY THE SAMPLING PLAN FOR ROUTINE MONITORING OF THE EDWARDS BALLOON CATHETER, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, NOVAFLEX+ DELIVERY SYSTEM AND ASCENDRA+ DELIVERY SYSTEM.
P110021|S041|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2014|08/04/2014|||OK30|MODIFY THE SAMPLING PLAN FOR ROUTINE MONITORING OF THE EDWARDS BALLOON CATHETER, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, NOVAFLEX+ DELIVERY SYSTEM AND ASCENDRA+ DELIVERY SYSTEM.
P110013|S042|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2014|11/19/2014|||APPR|APPROVAL TO MODIFY THE DRUG SPRAY COATING PROCESS.
P930027|S016|SIEMENS HEALTHCARE DIAGNOSTICS INC.|GLYN RHONWY, LLANBERIS||GWYNEDD LL55 4EL||LL554||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|12/02/2014|||APPR|APPROVAL FOR AN ADDITIONAL ASSESSMENT METHOD BY UTILIZING A PANEL OF 10 NORMAL MALE SERA AND A RELEASE PANEL OF PATIENT POOLS TO MAINTAIN THE PERFORMANCE OF THE DEVICE ALIGNED TO THE WHO STANDARD 96/670.
P860004|S209|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|DRUG DELIVERY CATHETERS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2014|07/24/2014|||OK30|MANUFACTURING LINE MOVE ON THE SAME CHASKA, MINNESOTA CAMPUS, CHANGE IN THE INSPECTION ASSEMBLY PROCESS, REMOVAL OF A CLEANING STEP, AND WILL DISCONTINUING A MANUAL FINGERPULL TEST.
P010013|S058|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED EDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/27/2014|10/28/2014|||APPR|APPROVAL FOR DEVICE MODIFICATIONS, INCLUDING FLATTENING OF THE NVSRAM BATTERY CLIP AND ADDITION OF KAPTON TAPE TO THE NVSRAM BATTERY AND THE UI BOARD SHIELD TO OVERCOME A DEVICE ERROR  OCCURRING IF CONTACT OF THESE COMPONENTS OCCURS.
P100018|S011|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICES,PIPELINE FLEX EMBOLIZATION DEVICE|OUT|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/2014|01/26/2015|||APPR|APPROVAL FOR DESIGN CHANGES TO THE DELIVERY SYSTEM OF THE PIPELINE¿ EMBOLIZATION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, PIPELINE¿ FLEX EMBOLIZATION DEVICE (PFED), AND REMAINS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (22 YEARS OF AGE OR OLDER) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS (IAS) IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS.
P040045|S045|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2014|07/23/2014|||OK30|ADD A SECOND SUPPLIER FOR THE SENOFILCON A MONOMER USED FOR MANUFACTURING VISTAKON (SENOFILCON A) BRAND CONTACT LENSES.
P840001|S274|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS IMPLATABLE RESTORE FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2014|07/22/2014|||OK30|USE A NEW SOFTWARE TEST PACKAGE.
P130021|S005|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE SYSTEM AND TRANSCATHETER AORTIC VALVE|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2014|08/12/2014|||APPR|APPROVAL FOR USE OF AN ALTERNATIVE END SEAL LABEL.
P120005|S025|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2014|07/24/2014|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE TRANSMITTER PACKAGING TRAY TO INCREASE MOLD CAPACITY AT THEIR SUPPLIER. THE TRANSMITTER IS A COMPONENT OF THE DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
P060039|S059|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/26/2014|09/04/2014|||APPR|APPROVAL FOR UPDATES TO THE FINISHED PRODUCT RELEASE CRITERIA FOR CONTENT UNIFORMITY AND ELUTION FOR THE ATTAIN STARFIX MODEL 4195 LEAD.
P110002|S007|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|LDR SPINE MOBI-C CERVICAL DISC PROTHESIS (ONE LEVEL INDICATION)|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2014|07/23/2014|||OK30|ADD BACK-UP EQUIPMENT TO A MANUFACTURING PROCESS.
P020045|S058|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION  CATHETER & XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, 9F FREEZOR MAX SURGICAL CARDIAC|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2014|07/25/2014|||OK30|ALTERNATE SUPPLIER FOR CONNECTORS AND CONNECTOR FITTINGS AND ACCEPTANCE OF AN ALTERNATE ADHESIVE CURING PROCESS.
P110009|S007|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|LDR SPINE MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVEL INDICATION)|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2014|07/23/2014|||OK30|ADD BACK-UP EQUIPMENT TO A MANUFACTURING PROCESS.
P800036|S038|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2014|08/01/2014|||APPR|APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX (STERIS) IN NORTHBOROUGH, MASSACHUSETTS.
P120016|S003|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2014|08/07/2014|||OK30|MODIFICATION TO THE PROCESSING OF A SLEEVE COMPONENT.
P970004|S178|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR UNINARY CONTROL|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2014|07/25/2014|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO ADD A WARNING REGARDING THE RISK OF INCREASED OR UNCONTROLLED BLEEDING AND THE USE OF ANTICOAGULANTS PRIOR TO SURGERY FOR INTERSTIM THERAPY.
P080025|S074|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY FOR BOWEL CONTROL|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2014|07/25/2014|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO ADD A WARNING REGARDING THE RISK OF INCREASED OR UNCONTROLLED BLEEDING AND THE USE OF ANTICOAGULANTS PRIOR TO SURGERY FOR INTERSTIM THERAPY.
P980040|S049|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL)|MFK|OP|Panel Track|Change Design/Components/Specifications/Material|N|06/30/2014|12/17/2014|14M-2375|03/19/2015|APPR|APPROVAL FOR THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODELS ZKB00 AND ZLB00. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH ANDWITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THEINTRAOCULAR LENSES ARE INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P080012|S022|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/2014|12/18/2014|||APPR|APPROVAL FOR IMPLEMENTING A DESIGN CHANGE TO INCORPORATE A FLOW ACTUATED SAFETY VALVE (FAV) TO THE PROMETRA PUMP.
P120010|S029|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2014|11/12/2015|||APPR|APPROVAL FOR AN INCOMING RECEIVING MATERIAL SPECIFICATION CHANGE OF A CRITICAL DEVICE COMPONENT (GOX) USED IN THE SENSOR FABRICATION PROCESS FOR THE ENLITE SENSOR (MMT-7008) AND SOF-SENSOR (MMT-7002, MMT-7003). THESE SENSORS ARE COMPONENTS OF THE MINIMED 530G SYSTEM AND PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, IPRO RECORDER CGM SYSTEM, AND IPRO2 PROFESSIONAL CGM SYSTEM, RESPECTIVELY.
P980022|S159|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2014|11/12/2015|||APPR|APPROVAL FOR AN INCOMING RECEIVING MATERIAL SPECIFICATION CHANGE OF A CRITICAL DEVICE COMPONENT (GOX) USED IN THE SENSOR FABRICATION PROCESS FOR THE ENLITE SENSOR (MMT-7008) AND SOF-SENSOR (MMT-7002, MMT-7003). THESE SENSORS ARE COMPONENTS OF THE MINIMED 530G SYSTEM AND PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, IPRO RECORDER CGM SYSTEM, AND IPRO2 PROFESSIONAL CGM SYSTEM, RESPECTIVELY.
P970004|S179|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|VERIFY EVALUATION SYSTEM FOR INTERSTIM THERPY FOR URINARY CONTROL|EZW|GU|30-Day Notice||N|06/30/2014|07/30/2014|||OK30|ACCEPTANCE TO EXPAND THE MANUFACTURING ACCEPTANCE CRITERION.
P080025|S075|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR BOWEL CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|ACCEPTANCE TO EXPAND THE MANUFACTURING ACCEPTANCE CRITERION.
P130008|S002|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATOR|MNQ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/2014|02/05/2015|||APPR|APPROVAL FOR AN UPDATE TO THE TABLET HARDWARE AND OPERATING SYSTEM OF THE MODEL 2740 PHYSICIAN PROGRAMMER, AND RELATED CHANGES TO THE MODEL 2740 PROGRAMMER MANUAL.
P910023|S341|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/18/2014|||OK30|MODIFICATION TO THE CONNECTOR REINFORCEMENT PROCESS FOR HYBRID ASSEMBLIES.
P010012|S363|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONTAK CD, EASYTRAK, LIVIAN, COGNIS, ACUITY SPIRAL, ENERGEN, PUNCTUA, & INCEPTA CRT-D'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P030017|S202|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/2014|12/19/2014|||APPR|APPROVAL FOR THE PRECISION M8 ADAPTER THAT WILL BE USED TO CONNECT THE PRECISION IMPLANTABLE PULSE GENERATOR (IPG) OR THE PRECISION SPECTRA IPG TO THE FOLLOWING MEDTRONIC (MDT) SCS LEADS: SPECIFY 2X8 MODEL 39286, SPECIFY 5-6-5 MODEL 39565, LX8 COMPACT MODEL 3778, LX8 STANDARD MODEL 3777, LX8 SUB-COMPACT MODEL 3776, TEST: LX8, COMPACT MODEL 3874, TEST: LX8 STANDARD MODEL 3873, TEST: LX8 SUB-COMPACT  MODEL 3875, MODEL 37081 EXTENSION,  MODEL 37083 EXTENSION, MODEL 37082 EXTENSION, VECTRIS SURESCAN® MRI LX8 SUBCOMPACT, MODEL 977A160, 977A175, 977A190, AND VECTRIS SURESCAN® MRI LX8 COMPACT, MODEL 977A260, 977A275, 977A290.
P030054|S272|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA, UNIFY, UNIFY ASSURA AND UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/18/2014|||OK30|MODIFICATION TO THE CONNECTOR REINFORCEMENT PROCESS FOR HYBRID ASSEMBLIES.
P020025|S063|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/18/2014|||OK30|MANUFACTURING CHANGE OF THE FINAL ELECTRICAL INSPECTION TEST METHOD.
P100045|S001|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF SYSTEM|MOM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/30/2014|08/29/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050047|S041|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2014|07/30/2014|||OK30|CHANGE IN THE INCOMING INSPECTION PROCEDURE FOR THE SODIUM HYALURONATE (NAHA) RAW MATERIAL.
P110033|S010|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2014|07/30/2014|||OK30|CHANGE IN THE INCOMING INSPECTION PROCEDURE FOR THE SODIUM HYALURONATE (NAHA) RAW MATERIAL.
N970012|S099|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 TM INFLATABLE PENILE PROSTHESIS(IPP) WITH INHIBIZONE TREATMENT|JCW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2014|12/08/2014|||APPR|APPROVAL FOR USE OF DIFFERENT EQUIPMENT BY A VENDOR TO QUANTIFY THE LEVEL OF ANTIMICROBIAL ACTIVE INGREDIENT.
P000053|S051|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800TM URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT|EZY|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2014|12/08/2014|||APPR|APPROVAL FOR USE OF DIFFERENT EQUIPMENT BY A VENDOR TO QUANTIFY THE LEVEL OF ANTIMICROBIAL ACTIVE INGREDIENT.
P040037|S070|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2014|07/31/2014|||OK30|AUTOMATION OF THE PRESENTATION AND CUTTING PROCESS FOR CATHETER MANUFACTURING AND REMOVAL OF RELATED INSPECTIONS.
P130006|S010|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2014|07/31/2014|||OK30|AUTOMATION OF THE PRESENTATION AND CUTTING PROCESS FOR CATHETER MANUFACTURING AND REMOVAL OF RELATED INSPECTIONS.
P930029|S044|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF ENHANCR II, RF MARINR 7FR, RF MARINR 5FR, RF MARINR UNIPOLAR, RF CONTACTR, RF CONDUCTR|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2014|09/10/2014|||APPR|APPROVAL FOR CHANGES TO SOLDER AND WIRE REQUIRED TO MEET THE EUROPEAN DIRECTIVE 2011/65/EU ¿ RESTRICTION OF THE USE OF CERTAIN HAZARDOUS SUBSTANCES IN ELECTRICAL AND ELECTRONIC EQUIPMENT.
P030005|S112|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL TR, INVIVE AND INTUA CRT-P'S|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P960016|S047|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2014|08/22/2014|||APPR|APPROVAL FOR A CHANGE FROM THE CURRENT MYLAR FRONT PANEL PACKAGING POUCH MATERIAL TO BIAX NYLON FRONT PANEL PACKAGING POUCH MATERIAL FOR THE CURRENTLY APPROVED LIVEWIRE TC ABLATION CATHETER.
N970003|S166|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSAR, PULSAR MAX, INSIGNIA, ALTRUA, ADVANTIO & INGENIO PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P830060|S080|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P910073|S127|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P910077|S145|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX AND VENTAK MINI|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P960004|S066|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P960040|S323|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VENTAK AV/PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA, ENERGEN, & INCEPTA ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P960006|S043|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P930035|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK P2 PACEMAKER|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P950001|S027|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|SELUTE LEAD SYSTEM|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2014|07/30/2014|||OK30|CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE  DEVICES.
P030009|S079|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|07/31/2014|||OK30|CHANGES TO THE SUB-ASSEMBLY MANUFACTURING PROCESS.
P110013|S043|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|07/31/2014|||OK30|CHANGES TO THE SUB-ASSEMBLY MANUFACTURING PROCESS.
P040024|S076|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, PERLANE, RESTYLANE L, PERLANE L, RESTYLANE SILK INJECTABLE GELS|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|12/08/2014|||APPR|APPROVAL FOR THE PROPOSED INTRODUCTION OF AN ALTERNATE BULK MANUFACTURING ROOMIN THE MANUFACTURING PROCESS USED IN FACTORY 2 (F2) AT THE QMED FACILITY IN UPPSALA, SWEDEN.
P840001|S275|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREULTRA RECHARGEABLE NEUROSTIMULATOR, RESTOREADVANCED RECHARGEABLE NEUROSTIMULATOR, RESTOREULTRA SURESCAN MRI|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|08/01/2014|||OK30|ADDITION OF NEW WELDING EQUIPMENT.
P960009|S198|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA RC RECHARGEABLE NEUROSTIMULATOR|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|08/01/2014|||OK30|ADDITION OF NEW WELDING EQUIPMENT.
P010068|S040|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|12/17/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE.
P990071|S028|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|BIOSENSE WEBSTER CABLES|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|12/17/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE.
P990025|S040|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NAVISTAR CATHETER, NAVISTAR RMT CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|12/17/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE.
P950005|S051|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS RMT CATHETER, CLESIUS FLTR, DEFLECTABLE DISGNOSTIC/ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|12/17/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE.
P040036|S044|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|12/17/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE.
P030031|S059|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|12/17/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE.
P030053|S018|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|07/30/2014|||OK30|CHANGE TO REMOVE THE IN PROCESS GEL COHESION TEST THAT IS PERFORMED DURING THE MANUFACTURE OF THE GEL THAT IS USED TO FILL THE MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.
P910023|S342|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2014|09/12/2014|||APPR|APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.
P030054|S273|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2014|09/12/2014|||APPR|APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.
P030035|S123|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/ FRONTIER II / ANTHEM FAMILY OF CRT-P'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2014|09/12/2014|||APPR|APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.
P970013|S060|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2014|09/12/2014|||APPR|APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.
P890003|S311|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, ANALYZER, VITATRON LEGACY, VITATRON|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P820003|S129|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P850051|S081|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST,PREMIER, PREVAIL, VITATRON LEGACY SR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P900061|S129|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P920015|S133|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PCD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P930022|S016|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LEGEND PLUS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P970012|S095|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|KAPPA 400|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P980016|S489|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST, GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA DF4, PROTECTA, PROTECTA XT DF4,|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P980035|S382|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA, SENSIA, SIGMA,|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P980050|S092|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF, GEM III AT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P880086|S245|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY, INTEGRITY, VICTORY, ZEPHYR, & ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2014|09/12/2014|||APPR|APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.
P880006|S089|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2014|09/12/2014|||APPR|APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.
P050027|S006|KARL STORZ ENDOSCOPY-AMERICA, INC.|2151 E. GRAND AVE.||EL SEGUNDO|CA|90245||Light source system, diagnostic endoscopic|KARL STORZ PHOTODYNAMIC D-LIGHT C(PDD) SYSTEM -D-LIGHT C LIGHT SOURCE|OAY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2014|08/07/2014|||OK30|INCORPORATE NEW ELECTRICAL SAFETY TESTING EQUIPMENT TO REPLACE OLDER EQUIPMENT.
P990001|S118|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P010015|S242|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, INSYNC, INSYNC III, SYNCRA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P010031|S451|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC UCD, INSYNC II MARQUIS, INSY|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P090013|S147|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI, ENRHYTHM MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2014|09/05/2014|||APPR|APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.
P840001|S276|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|08/01/2014|||OK30|ADD ADDITIONAL PROCESSING EQUIPMENT.
P960009|S199|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|08/01/2014|||OK30|ADD ADDITIONAL PROCESSING EQUIPMENT.
P970004|S180|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|08/01/2014|||OK30|ADD ADDITIONAL PROCESSING EQUIPMENT.
P080025|S076|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|08/01/2014|||OK30|ADD ADDITIONAL PROCESSING EQUIPMENT.
P960040|S324|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEN EL ICD'S AND DYNAGEN, INOGEN, ORIGEN MINI ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|07/28/2014|||OK30|BLISTER SEALER PROCESS SETTING CHANGES FOR THE DEVICES.
P010012|S364|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN CRT-D, X4 CRT-D, INOGEN  CRT-D, X4CRT-D, OGIGEN CRT-D. X4 CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|07/28/2014|||OK30|BLISTER SEALER PROCESS SETTING CHANGES FOR THE DEVICES.
P980016|S490|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|07/30/2014|||OK30|ADDITIONAL EQUIPMENT FOR THE FILL HOLE SEAL WELD FOR THE HIGH VOLTAGE CAPACITOR.
P010031|S452|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|07/30/2014|||OK30|ADDITIONAL EQUIPMENT FOR THE FILL HOLE SEAL WELD FOR THE HIGH VOLTAGE CAPACITOR.
P900056|S142|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/03/2014|08/01/2014|||OK30|REMOVAL OF REDUNDANT INCOMING ACCEPTANCE TESTING
P000029|S078|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice||N|07/03/2014|07/31/2014|||OK30|QUALIFY AN ALTERNATE SUPPLIER OF THE READY-PREPARED SOLUTIONS OF NAOH AND HCL USED FOR THE MANUFACTURING OF DEFLUX DEVICE.
P980035|S383|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2014|07/28/2014|||OK30|UPDATE TO SEAM WELD PARAMETERS FOR THE DEVICES.
P950008|S012|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILICOM(TM) 1000 RETINALTAMPONADE|LWL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2014|11/03/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN  FORT WORTH, TEXAS.
P930016|S043|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/07/2014|10/02/2014|||APPR|APPROVAL FOR REDESIGN OF THE STAR THYRATRON TRIGGER BOARD(P/N 0040-0044).
P100023|S103|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2014|08/05/2014|||OK30|CHANGE TO THE ENDOTOXIN SAMPLING PLAN.
P110010|S091|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/ PREMIER EVEROLIMUS- ELUTING PLATINUN CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2014|08/05/2014|||OK30|CHANGE TO THE ENDOTOXIN SAMPLING PLAN.
P910062|S007|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/07/2014|10/02/2014|||APPR|APPROVAL FOR REDESIGN OF THE STAR THYRATRON TRIGGER BOARD(P/N 0040-0044).
P990010|S007|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/07/2014|10/02/2014|||APPR|APPROVAL FOR REDESIGN OF THE STAR THYRATRON TRIGGER BOARD(P/N 0040-0044).
P020014|S042|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM FOR PERMANENT BIRTH  CONTROL|HHS|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/07/2014|12/11/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P120010|S030|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/07/2014|02/04/2015|||APPR|APPROVAL FOR CHANGES TO THE SENSOR BASE WHICH INCLUDED; THE ADDITION OF ANTI-ROTATION PINS AND SNAP ARMS, MODIFICATION OF THE O-RING GLAND; WIDTH, POSITION, AND DIAMETER, AN INCREASE TO THE BORE SIZE AND ADDITION OF A BORE TAPER, A SENSOR THROUGH-HOLE SIZE INCREASE, AND CONNECTOR PAD SURFACE HEIGHT INCREASE, ON THE ENLITETM GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM.
P100014|S015|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2014|08/07/2014|||OK30|INTRODUCTION OF AN ALTERNATE SUPPLIER FOR TWO PROCESS CHEMICALS USED IN THE BULK MANUFACTURING PROCESS OF SOLESTA.
N12159|S033|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FAMILY OF HEMOSTATS|LMG|SU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2014|09/24/2014|||APPR|APPROVAL TO INCLUDE X-RAY IRRADIATION AS AN ALTERNATIVE STERILIZATIONPROCESS.
N16837|S015|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/07/2014|07/14/2014|||APPR|APPROVAL FOR A LABELING CHANGE TO MODIFY THE SIZING CONVENTION FROM OUTER DIAMETER TO INNER DIAMETER OF THE GRAFT.
P100030|S004|MALLINCKRODT PHARMA IP TRADING DAC|DAMASTOWN INDUSTRIAL ESTATE||MULHUDDART||||Sealant,polymerizing|PREVELEAK SURGICAL SEALANT|NBE|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|05/22/2014|07/31/2014|||APPR|APPROVAL FOR A PRODUCT TRADE NAME CHANGE FROM ARTERX® SURGICAL SEALANT TO PREVELEAK SURGICAL SEALANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PREVELEAK SURGICAL SEALANT AND IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
P130030|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2014|08/04/2014|||OK30|CHANGE TO ADD ETHYLENE OXIDE STERILIZATION CHAMBERS TO STERILIZE THE SUBJECT DEVICE.
P040034|S024|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/2014|12/11/2014|||APPR|APPROVAL FOR A CHANGE TO THE DIRECTIONS FOR USE (DFU) TO EXPAND THE PATIENT POPULATION TO >= 13 YEARS OF AGE.
P920015|S134|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2014|07/28/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR MANUFACTURE OF THE BIFILAR ELECTRODE COIL FOR THE DEVICES.
P040024|S077|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE-PERLANE-RESTYLANE-L/PERLANE-L AND RESTYLANE-SILK INJECTABLE GELS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2014|08/07/2014|||OK30|CHANGES TO THE ENVIRONMENTAL CONDITIONS IN FACTORY 1 AND FACTORY 2 AT THE QMED FACILITY IN UPPSALA, SWEDEN.
P010030|S055|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST DEVICE|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2014|08/07/2014|||OK30|CHANGE IN THE IN-PROCESS TESTING OF THE LIFEVEST® WEARABLE DEFIBRILLATOR.
P100026|S022|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/09/2014|09/05/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P940015|S033|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC, SYNVISC-ONE|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/09/2014|08/21/2014|||APPR|APPROVAL FOR THE UPDATING OF THE PACKAGE INSERT AND PATIENT INFORMATION LEAFLET WITH RESPECT TO ADVERSE EVENT INFORMATION ON PSEUDOSEPSIS,  ALLERGIC REACTIONS, AND HYPERSENSITIVITY.
P010032|S083|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ST. JUDE MEDICAL ADAPTER|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/10/2014|10/15/2014|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE SINGLE 8 EXTENSION (MODEL3383) TO INTRODUCE A NEW 8-CHANNEL ADAPTER (MODELS 2311 AND 2316) FOR SPINAL CORD STIMULATION (SCS) SYSTEMS. THE NEW 8-CHANNEL ADAPTER IS INTENDED TO CONNECT A COMPATIBLE 8-CHANNEL MEDTRONIC LEAD OR EXTENSION TO A ST. JUDE MEDICAL IMPLANTABLE PULSE GENERATOR.
P030011|S026|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2014|08/07/2014|||OK30|NEW SUPPLIER FOR THE FREEDOM DRIVER SYSTEM BATTERY.
P030049|S011|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG (HBS) ASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|07/10/2014|10/28/2014|||APPR|APPROVAL FOR THE ADDITION OF TWO WASHES OF THE ANCILLARY PROBE ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP INSTRUMENTS WHEN THE ADVIA CENTAUR HBSAG ASSAY IS RUN IMMEDIATELY FOLLOWING THE ADVIA CENTAUR SYPHILIS ASSAY.
P110023|S010|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/10/2014|09/03/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P830055|S146|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2014|08/08/2014|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MODEL CREATION PROCESS FOR THE TRUMATCH RESECTION GUIDES.
P090013|S148|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2014|08/08/2014|||OK30|NEW FIXTURE FOR THE PULL TESTING AT MSO FOR THE DEVICES.
P930039|S112|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2014|08/08/2014|||OK30|NEW FIXTURE FOR THE PULL TESTING AT MSO FOR THE DEVICES.
P830061|S110|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2014|08/08/2014|||OK30|NEW FIXTURE FOR THE PULL TESTING AT MSO FOR THE DEVICES.
P010047|S036|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/11/2014|02/13/2015|15M-0502|03/19/2015|APPR|APPROVAL FOR THE PROGEL PLEURAL AIR LEAK SEALANT (PALS). THE SINGLE USE PROGEL PLEURAL AIR LEAK SEALANT DEVICE IS INDICATED FOR APPLICATION TO VISCERAL PLEURA AFTER STANDARD VISCERAL PLEURAL CLOSURE WITH, FOR EXAMPLE, SUTURES OR STAPLES, OF VISIBLE AIR LEAKS INCURRED DURING RESECTION OF LUNG PARENCHYMA.
P100009|S007|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2014|08/13/2014|||OK30|DENSITY RANGE CHANGES (FOR CARTONS AND PALLETS) AND 5 MINOR PROCESS CHANGES AS A PART OF THE ANNUAL REVALIDATION OF STERILIZATION.
P020049|S003|LEMAITRE VASCULAR INC|63 SECOND AVENUE||BURLINGTON|MA|01803||TISSUE GRAFT OF 6MM AND GREATER|PROCOL VASCULAR BIOPROSTHESIS|LXA|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2014|09/29/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
P840001|S277|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL TOTALLY IMPLANTABLE SPINAL CORD STIMULATOR SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2014|08/08/2014|||OK30|CHANGES TO THE SEALING PROCESS EQUIPMENT.
P020050|S017|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVE LIGHT EX500 LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/14/2014|12/17/2014|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR A CAMERA SENSOR COMPONENT OF THEEYETRACKER CAMERA FOR THE WAVELIGHT® EX500 LASER SYSTEM.
P130009|S002|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/14/2014|09/12/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P850089|S108|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD, CAPSURE SP NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2014|08/12/2014|||OK30|TRANSFER OF COMPONENT MANUFACTURING TO A DIFFERENT INTERNAL SUPPLIER FOR THE TWO MCRD (MONOLITHIC CONTROLLED RELEASE DEVICE) COMPONENTS USED IN THE CARDIAC LEAD MODELS.
P830061|S111|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2014|08/12/2014|||OK30|TRANSFER OF COMPONENT MANUFACTURING TO A DIFFERENT INTERNAL SUPPLIER FOR THE TWO MCRD (MONOLITHIC CONTROLLED RELEASE DEVICE) COMPONENTS USED IN THE CARDIAC LEAD MODELS.
P890003|S312|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAP SURE VDD-2 LEAD, VITATRON BRILLIANT S+ VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2014|08/12/2014|||OK30|TRANSFER OF COMPONENT MANUFACTURING TO A DIFFERENT INTERNAL SUPPLIER FOR THE TWO MCRD (MONOLITHIC CONTROLLED RELEASE DEVICE) COMPONENTS USED IN THE CARDIAC LEAD MODELS.
P950024|S060|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2014|08/12/2014|||OK30|TRANSFER OF COMPONENT MANUFACTURING TO A DIFFERENT INTERNAL SUPPLIER FOR THE TWO MCRD (MONOLITHIC CONTROLLED RELEASE DEVICE) COMPONENTS USED IN THE CARDIAC LEAD MODELS.
P910001|S072|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER|LPC|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2014|10/09/2014|||APPR|APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS.
P960042|S049|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT)|MFA|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2014|10/09/2014|||APPR|APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS.
P920015|S135|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2014|08/08/2014|||OK30|ADD A NEW COMPONENT SUPPLIER.
P030008|S015|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVE LIGHT EX500 LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/14/2014|12/17/2014|||APPR|APPROVAL FOR AN ALTERNATE SUPPLIER FOR A CAMERA SENSOR COMPONENT OF THEEYETRACKER CAMERA FOR THE WAVELIGHT® EX500 LASER SYSTEM.
P950034|S042|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2014|08/12/2014|||OK30|ADDITIONAL SITE FOR QUARTERLY IRRADIATION DOSE VERIFICATION FOR THE SEPRAFILM ADHESION BARRIER.
P010015|S243|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|07/24/2014|||OK30|MANUFACTURING CHANGES TO ALIGN THE PRODUCTION OF VIVA CRT-P WITH EXISTING MARKET APPROVED PRODUCTS.
P100047|S048|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|08/13/2014|||OK30|IMPLEMENTATION OF A NEW MECHANIZED IMPELLER POLISHING PROCESS.
P050017|S010|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|08/14/2014|||OK30|ADD A MANUFACTURING STEP TO THE HANDLE ASSEMBLY OF THE DELIVERY SYSTEM.
P990075|S026|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|SPECTRUM BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|08/12/2014|||OK30|CHANGE THE SUPPLIER OF AN ADDITIVE AND REPLACE THE ADDITIVE WITH ANOTHER VERSION OF THE SAME MATERIAL.
P960011|S026|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||AID, SURGICAL, VISCOELASTIC|BVI 1% OVD|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|08/12/2014|||OK30|ADDITION OF A NEW AUTOMATED THERMOFORMING MACHINE ANDPACKAGING PROCESS.
P010031|S453|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|07/24/2014|||OK30|MANUFACTURING CHANGES TO ALIGN THE PRODUCTION OF VIVA AND BRAVA MODELS WITH EXISTING MARKET APPROVED PRODUCTS.
P130009|S003|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|08/07/2014|||OK30|ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.
N18033|S074|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON ETAFILCON A BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|08/14/2014|||OK30|ADDITION OF A QUALITY CONTROL SAMPLING PLAN.
P040045|S046|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON SENOFILCON A BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|08/14/2014|||OK30|ADDITION OF A QUALITY CONTROL SAMPLING PLAN.
P980016|S491|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR IC&, VR,  XT DR, &  XT VR ICD, MAXIMO II ICD, PROTECTA & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|07/22/2014|||OK30|MODIFICATION ON LASER SEAM WELDER EQUIPMENT AT A FINAL DEVICE MANUFACTURING FACILITY FOR THE DEVICES.
P010031|S454|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA/ BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA, MAXIMO II, PROTECTA, PROTECTA  XT ,VIVA QUAD S/XT/S CRT-D'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2014|07/22/2014|||OK30|MODIFICATION ON LASER SEAM WELDER EQUIPMENT AT A FINAL DEVICE MANUFACTURING FACILITY FOR THE DEVICES.
P860004|S210|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION  SYSTEM|LKK|HO|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/15/2014|08/14/2014|||APPR|APPROVAL FOR PRIMING BOLUS LABELING UPDATES.
P040002|S053|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX VELA PROXIMAL ENDOGRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2014|08/12/2014|||APPR|APPROVAL FOR AN ADDITIONAL IN PROCESS X-RAY INSPECTION STEP.
P110012|S007|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT|OWE|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/14/2014|12/10/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE PROBECHK ALK POSITIVE AND NEGATIVE CONTROL SLIDE LABELING, AND EXPANSION OF THE ASSAY GUARD BAND PARAMETERS.
P950029|S092|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2014|07/28/2014|||OK30|CHANGE TO A SINGLE PASS PROCESS FOR SCREEN PRINTING AND REFLOW SOLDERING.
P100041|S055|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHER HEART VALVE|NPT|CV|135 Review Track For 30-Day Notice||N|07/17/2014|10/19/2015|||APPR|APPROVAL FOR A MANUFACTURING LINE CHANGE AND THE USE OF AMMONIUM PERFLUOROOCTANOATE (APFO) FREE RESIN AT LENZING PLASTICS GMBH, AN EDWARDS APPROVED SUPPLIER.
P110021|S042|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|135 Review Track For 30-Day Notice||N|07/17/2014|10/19/2015|||APPR|APPROVAL FOR A MANUFACTURING LINE CHANGE AND THE USE OF AMMONIUM PERFLUOROOCTANOATE (APFO) FREE RESIN AT LENZING PLASTICS GMBH, AN EDWARDS APPROVED SUPPLIER.
P130009|S004|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; EDWARDS QUALCRIMP CRIMPING ACCESSORY|NPT|CV|135 Review Track For 30-Day Notice||N|07/17/2014|10/19/2015|||APPR|APPROVAL FOR A MANUFACTURING LINE CHANGE AND THE USE OF AMMONIUM PERFLUOROOCTANOATE (APFO) FREE RESIN AT LENZING PLASTICS GMBH, AN EDWARDS APPROVED SUPPLIER.
P100041|S056|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/17/2014|08/28/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S127|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AOTIC BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS|DYE|CV|135 Review Track For 30-Day Notice||N|07/17/2014|10/19/2015|||APPR|APPROVAL FOR A MANUFACTURING LINE CHANGE AND THE USE OF AMMONIUM PERFLUOROOCTANOATE (APFO) FREE RESIN AT LENZING PLASTICS GMBH, AN EDWARDS APPROVED SUPPLIER.
P040043|S067|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|07/18/2014|10/21/2014|||APPR|APPROVAL FOR AN UPDATE TO THE LABELING FOR THE GORE TAG THORACICENDOPROSTHESIS TO REFLECT THE FINDINGS OF THE POST-APPROVAL STUDY.
P890003|S313|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION|OSR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2014|01/26/2015|||APPR|APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE: THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONIC IMPLANTED HEART DEVICE. THE APPLICATION ON  SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK.  MOBILE APPLICATION INDICATIONS FOR USE:  THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.
P980016|S492|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR/S VR,XT DR, XT VR ICD; ENTRUST; INTRINSIC 30 & INTRINSIC ICD; MARQUIS DR, VR ICD; MAXIMO DR, II, VR ICD; PROT|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2014|01/26/2015|||APPR|APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR ANDTHE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE:THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONICIMPLANTED HEART DEVICE. THE APPLICATION ON  SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK.  MOBILE APPLICATION INDICATIONS FOR USE:THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.
P980035|S384|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENTHYTHM, KAPPA D (KAPPA 700) IPG & KAPA|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2014|01/26/2015|||APPR|APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR ANDTHE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE:THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONICIMPLANTED HEART DEVICE. THE APPLICATION ON  SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK.  MOBILE APPLICATION INDICATIONS FOR USE:THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.
P010015|S244|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNERA CRT-P|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2014|01/26/2015|||APPR|APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE: THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONIC IMPLANTED HEART DEVICE. THE APPLICATION ON  SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK.  MOBILE APPLICATION INDICATIONS FOR USE: THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.
P030050|S022|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2014|01/06/2015|||APPR|APPROVAL FOR A NEW AUTOCLAVE.
P110028|S013|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2014|08/15/2014|||OK30|SUPPLIER CHANGE FOR THE MANUFACTURING OF THE GUIDEWIRE LUMEN.
P010031|S455|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA ICD, INSYNC II PROTECT ICD ,III MARQUIS ICD, INSYNC MAXIMO ICD,|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2014|01/26/2015|||APPR|APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR ANDTHE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE:THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONICIMPLANTED HEART DEVICE. THE APPLICATION ON  SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK.  MOBILE APPLICATION INDICATIONS FOR USE:THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.
P090013|S149|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2014|01/26/2015|||APPR|APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE: THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONICIMPLANTED HEART DEVICE. THE APPLICATION ON  SMART PHONE OR TABLET TRANSMITS IMPLANTED HEART DEVICE DATA TO THE MEDTRONIC CARELINK NETWORK.  MOBILE APPLICATION INDICATIONS FOR USE: THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.
P100018|S012|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2014|08/20/2014|||OK30|SUPPLIER PROCESS CHANGES TO THE PIPELINE EMBOLIZATION DEVICE.
P990064|S057|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHETIC HEART VALVE|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/2014|02/25/2015|||APPR|APPROVAL FOR A CHANGE TO THE STENT MATERIAL FROM ACETALHOMOPOLYMER (AHP) TO POLYETHERETHERKETONE, PEEK I5R (PEEK) FOR THE DEVICES.
P980043|S048|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PROCINE BIOPROSTHETIC HEART VALVE|DYE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/2014|02/25/2015|||APPR|APPROVAL FOR A CHANGE TO THE STENT MATERIAL FROM ACETALHOMOPOLYMER (AHP) TO POLYETHERETHERKETONE, PEEK I5R (PEEK) FOR THE DEVICES.
P110023|S011|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2014|08/20/2014|||OK30|CHANGE TO THE MANUAL PROCESS FOR MEASURING STENT DIMENSIONS TO AN AUTOMATED PROCESS.
P060001|S022|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, ILIAC|PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2014|08/20/2014|||OK30|CHANGE TO THE MANUAL PROCESS FOR MEASURING STENT DIMENSIONS TO AN AUTOMATED PROCESS.
P120005|S026|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2014|10/09/2014|||APPR|APPROVAL FOR A NEW INTERNET-BASED SOFTWARE UPDATE TOOL.
P950029|S093|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2014|08/12/2014|||OK30|UPDATE OF THE IN-PROCESS STEPS ON THE ELECTRONIC ASSEMBLY LINE.
P840001|S278|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|INJEX ANCHOR KITS AND VECTRIS SURESCAN MRI LEAD KITS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2014|08/19/2014|||OK30|MANUFACTURING CHANGES TO THE CAVITY MOLDS.
P030023|S004|OPHTEC USA, INC.|6421 CONGRESS AVE., SUITE 112||BOCA RATON|FL|33487||Ring, endocapsular|CAPSULAR TENSION RING AND STABILEYES|MRJ|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/21/2014|11/13/2015|||APPR|APPROVAL TO INCLUDE THE RINGJECT, A DISPOSABLE INJECTOR/DELIVERY SYSTEM DESIGNED FOR USE WITH CAPSULAR TENSION RINGS (CTRS), ADDITION OF THE INJECTOR INTO THE SAME STERILE PACKAGING PROCESS AS THE CTR AND MODIFICATION OF THE PACKAGING CONFIGURATION TO ACCOMMODATE THE COMBINED INJECTOR AND THE PRELOADED CTR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RINGJECT, MODEL 375 AND MODEL 376. CTRS ARE INDICATED FOR THE STABILIZATION OF WEAKENED, BROKEN, OR MISSING ZONULES THAT ARE SUSPECTED OR OBSERVED DURING CATARACT EXTRACTION USING PHACOEMULSIFICATION AND CONTINUOUS CURBILINEAR CAPSULORHEXIS TECHNIQUES IN ADULTS.
P130009|S005|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2014|08/07/2014|||OK30|ADDITION OF A NEW BOVINE TISSUE SUPPLIER.
P100026|S023|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2014|08/21/2014|||OK30|ADDITIONAL EQUIPMENT FOR LASER MARKING.
P060033|S092|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/2014|10/17/2014|||APPR|APPROVAL OF UPDATES TO THE INSTRUCTIONS FOR USE TO ACCURATELY REFLECT THE CORRECT SAFETY FACTORS FOR THE ZOTAROLIMUS DRUG SUBSTANCE.
P120006|S014|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2014|09/09/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE FILL POLYMER KIT.
P900009|S037|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN ULTRASOUND BONE HEALING SYSTEM|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2014|08/21/2014|||OK30|MOVEMENT OF THE MANUFACTURING PROCESS OF A COMPONENT TO A NEW FACILITY.
P970051|S122|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/22/2014|||OK30|ACCEPTANCE OF A NEW QUALITY CONTROL TEST SYSTEM.
P050037|S051|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 0.8CC, RADIESSE1.5CC, RADIESSE 3.0 CC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/20/2014|||OK30|CHANGES TO THE AUTOCLAVE CONTROL MECHANISM AND PREPARATION OF LOAD PROBES FOR THE EQUIPMENT SANITIZATION CYCLE ASSOCIATED WITH THE RADIESSE DERMAL FILLER.
P130016|S008|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/22/2014|||OK30|ACCEPTANCE OF A NEW QUALITY CONTROL TEST SYSTEM.
P050052|S056|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 0.8CC, RADIESSE 1.5CC, RADIESSE 3.0CC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/20/2014|||OK30|CHANGES TO THE AUTOCLAVE CONTROL MECHANISM AND PREPARATION OF LOAD PROBES FOR THE EQUIPMENT SANITIZATION CYCLE ASSOCIATED WITH THE RADIESSE DERMAL FILLER.
P100010|S041|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CRYOBALLOON CATHETER, ARCTIC FRONT ADVANCE CRYOBALLOON CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/22/2014|||OK30|UPDATES TO THE MANUFACTURING STEPS DURING THE HEAT SHRINK PROCESS FOR THE GUIDE WIRE LUMEN IN THE ARCTIC FRONT AND ARCTIC FRONT ADVANCE CATHETERS.
P050037|S052|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 0.8 CC, RADIESSE 1.5CC, RADIESSE 3.0CC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/19/2014|||OK30|RELOCATION OF THE QUALITY INCOMING INSPECTION LAB, INSTALLATION OF THE QC CLEAN ROOM AND INSTALLATION OF AN AUTOMATED TEMPERATURE/HUMIDITY MONITORING SYSTEM.
P050052|S057|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 0.8CC, RADIESSE 1.5CC, RADIESSE 3.0 CC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/19/2014|||OK30|RELOCATION OF THE QUALITY INCOMING INSPECTION LAB, INSTALLATION OF THE QC CLEAN ROOM AND INSTALLATION OF AN AUTOMATED TEMPERATURE/HUMIDITY MONITORING SYSTEM.
P090003|S035|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/2014|10/10/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE MRI SECTIONS OF THE PRODUCT LABELING.
P040020|S055|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOL IQ RESTOR|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/20/2014|||OK30|CHANGE IN CALCULATION METHOD FOR A QUALITY CONTROL TEST.
P980035|S385|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/13/2014|||OK30|RESIN AND CATALYST PRESSURE RANGE CHANGES OF THE EPOXY DISPENSE FOR THE DEVICES.
P130008|S003|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATOR|MNQ|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/23/2014|09/19/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P980016|S493|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/15/2014|||OK30|CHANGE OF A CLEANING CHEMICAL USED IN THE MANUFACTURE OF THE FLEX CIRCUIT COMPONENT USED IN THE DEVICES.
P010031|S456|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|08/15/2014|||OK30|CHANGE OF A CLEANING CHEMICAL USED IN THE MANUFACTURE OF THE FLEX CIRCUIT COMPONENT USED IN THE DEVICES.
P050044|S029|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL RT3 SURGICAL HEMOSTAT|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2014|12/12/2014|||APPR|APPROVAL FOR THE RELOCATION OF CERTAIN MANUFACTURING EQUIPMENT USED FOR ASSEMBLY AND PACKAGING OF VITAGEL RT3 SURGICAL HEMOSTAT FROM ONE ROOM TO ANOTHER ROOM WITHIN THE FIRMS MALVERN, PENNSYLVANIA FACILITY.
P930014|S074|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF(R) IQ TORIC INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|04/30/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON LABORATORIES IRELAND LTD., IN CORK, IRELAND.
P100026|S024|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/22/2014|||OK30|MODIFY THE CORTICAL STRIP LEAD DISTAL ASSEMBLY MOLDING PROCESS.
P010015|S245|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P890003|S314|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ANALYZER ADAPTOR, ANALYZER CABLE|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/24/2014|08/29/2014|||APPR|APPROVAL FOR THE QUALIFICATION OF STERILIZATION PARAMETERS FOR THE REFERENCED SURGICAL CABLES AND ACCESSORIES.
P010031|S457|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P820003|S130|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PATIENT CABLE, SURGICAL CABLE|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/24/2014|08/29/2014|||APPR|APPROVAL FOR THE QUALIFICATION OF STERILIZATION PARAMETERS FOR THE REFERENCED SURGICAL CABLES AND ACCESSORIES.
P110012|S008|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT|OWE|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/14/2014|||OK30|REPLACEMENT OF THE FERMENTERS USED IN THE FERMENTATION PROCESSES.
P030036|S072|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT, SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P060039|S060|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P080006|S069|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P120005|S027|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/22/2014|||OK30|RELOCATION OF RECEIVING AND RECEIVING INSPECTION ACTIVITIES TO A NEW WAREHOUSEFACILITY.
P030052|S016|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/14/2014|||OK30|REPLACEMENT OF THE FERMENTERS USED IN THE FERMENTATION PROCESSES.
P950024|S061|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P980016|S494|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA I|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P980035|S386|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P980050|S093|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P830061|S112|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P850089|S109|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,  VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P890003|S315|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2, VITATRON BRILLIANT S+ VDD LEAD, VITATRON BRILLIANT S+ VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P900061|S130|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|END CAP, EPICARDIAL PATCH LEAD, UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P920015|S136|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P930039|S113|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P090013|S150|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2014|08/20/2014|||OK30|REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
P990009|S039|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2014|02/26/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAXTER HEALTHCARE CORPORATION IN CLEVELAND, MISSOURI.
P030005|S113|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INGENIO 2 CRT-P DEVICES AND INGENIO CRT-P DEVICES|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/2014|10/21/2014|||APPR|APPROVAL FOR INGENIO CRT-P DEVICES (INVIVE CRT-P MODELS V172, V173; INTUA CRT-P MODELS V272, V273); INGENIO 2 CRT-P DEVICES (VALITUDE MODEL U125; VALITUDE X4 MODEL U128).
N970003|S167|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ALTRUA 2, ESSENTIO, PROPONENT AND ACCOLADE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/2014|10/21/2014|||APPR|APPROVAL FOR INGENIO PACEMAKERS (ADVANTIO MODELS K062, K063, K064; INGENIO MODELS K172, K173, K174; VITALIO MODELS K272, K273, K274; FORMIO MODEL K278); INGENIO 2 PACEMAKERS (ALTRUA 2 MODEL: S701, S702, S722; ESSENTIO MODELS L100, L101, L121; PROPONENT MODELS L200, L201, L221; ACCOLADE MODELS L300, L301, L321) AND PROGRAMMER APPLICATION SOFTWARE MODEL 2869 V2.01.
P980035|S387|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, DR MRI IPG, ADAPTA, VERSA, SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2014|08/15/2014|||OK30|ALLOWANCE OF ROOM TEMPERATURE TESTING AT FINAL FUNCTIONAL TESTING SPECIFIC PROCESS FLOWS.
P860003|S076|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS UVAR XTS AND THERAKOS CELLEX PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2014|08/21/2014|||OK30|SUPPLIER CHANGE FOR A COMPONENT OF THE LIGHT ASSEMBLIES USED IN THERAKOS UVAR XTS AND CELLEX PHOTOPHERESIS SYSTEMS.
P990046|S038|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2014|08/20/2014|||OK30|AN ALTERNATE VISION SYSTEM FOR IN-PROCESS INSPECTION OF LEAFLET COMPONENTS.
P010012|S365|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2014|08/15/2014|||OK30|REMOVAL OF THE 36-MONTH SHELF LIFE FOR POLYURETHANE TUBING.
P050046|S024|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2014|08/15/2014|||OK30|REMOVAL OF THE 36-MONTH SHELF LIFE FOR POLYURETHANE TUBING.
P100021|S039|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT IIS STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/25/2014|10/23/2014|||APPR|APPROVAL FOR THE ADDITION OF FIVE (5) SHORT BIFURCATED STENT GRAFT CONFIGURATIONS TO THE ENDURANT II STENT GRAFT SYSTEM, WHICH ARE CALLED ENDURANT IIS STENT GRAFTS (ALSO REFERRED TO AS ENDURANT IIS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDURANT IIS STENT GRAFT SYSTEM. THE ENDURANT II/ENDURANT IIS BIFURCATED STENT GRAFTS ARE INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS. THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS IN PATIENTS WHOSE ANATOMY DOES NOT ALLOW THE USE OF BIFURCATED STENT GRAFT. THE ENDURANT II/ENDURANT IIS STENT GRAFT SYSTEM IS INDICATED FOR USE IN PATIENTS WITH THE FOLLOWING CHARACTERISTICS:1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES OR ACCESSORIES; 2) PROXIMAL NECK LENGTH >=10 MM;3) INFRARENAL NECK ANGULATION <=60°;4) AORTIC NECK DIAMETERS WITH A RANGE OF 19 TO 32 MM; 5) DISTAL FIXATION LENGTHS >=15 MM; 6) ILIAC DIAMETERS WITH A RANGE OF 8 TO 25 MM; AND 7) MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR.
P050037|S053|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2014|08/25/2014|||OK30|CHANGES RELATED TO THE RAW MATERIAL USED IN THE PRODUCTION OF CALCIUM HYDROXYLAPATITE (CAHA) COMPONENT.
P080020|S009|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2014|08/25/2014|||OK30|REPLACE A PREVIOUS AUTOCLAVE WITH A NEW AUTOCLAVE.
P050052|S058|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2014|08/25/2014|||OK30|CHANGES RELATED TO THE RAW MATERIAL USED IN THE PRODUCTION OF CALCIUM HYDROXYLAPATITE (CAHA) COMPONENT.
P980023|S060|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2014|09/16/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) A MINOR MODIFICATION (ADDITION OF INNER COATING) OF TO THE LINOXSMART/ VOLTA/PROTEGOICD LEADS;2) MODIFICATIONS TO THE CURRENT SUTURE SLEEVE TO CREATE A WHITE SUTURE SLEEVE; 3) PA 11 ADAPTER; AND4) LEAD TECHNICAL MANUAL/LABELING UPDATES.
P110033|S011|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA  XC|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2014|01/27/2015|||APPR|TRANSFER OF MODIFIED HYALURONIC ACID TESTING IN-HOUSE FROMA CONTRACT FACILITY.
P950037|S138|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2014|09/16/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) A MINOR MODIFICATION (ADDITION OF INNER COATING) OF TO THE LINOXSMART/ VOLTA/PROTEGOICD LEADS;2) MODIFICATIONS TO THE CURRENT SUTURE SLEEVE TO CREATE A WHITE SUTURE SLEEVE; 3) PA 11 ADAPTER; AND4) LEAD TECHNICAL MANUAL/LABELING UPDATES.
P920015|S137|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2014|08/14/2014|||OK30|A MINOR CHANGE TO THE PLASMA TREATMENT PROCESS USED ON SILICONE TUBING.
P930039|S114|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, SUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2014|08/14/2014|||OK30|A MINOR CHANGE TO THE PLASMA TREATMENT PROCESS USED ON SILICONE TUBING.
P060030|S043|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2014|08/22/2014|||OK30|CHANGE TO REVISE THE MANUFACTURING RELEASE SPECIFICATIONS FOR THE POSITIVECONTROLS PACKAGED AS PART OF THE COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST ANDCOBAS® TAQMAN HCV TEST VERSION 2.0 FOR USE WITH THE HIGH PURE SYSTEM.
P070008|S054|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CELERITY 2D/3D/PILOT STEROID-ELUTING LV LEAD, COROX (-S/-L) BP STEROID-ELUTING LV LEAD|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/28/2014|09/16/2014|||APPR|APPROVAL FOR THE FOLLOWING CHANGES:1) A MINOR MODIFICATION (ADDITION OF INNER COATING) OF TO THE LINOXSMART/ VOLTA/PROTEGOICD LEADS;2) MODIFICATIONS TO THE CURRENT SUTURE SLEEVE TO CREATE A WHITE SUTURE SLEEVE; 3) PA 11 ADAPTER; AND4) LEAD TECHNICAL MANUAL/LABELING UPDATES.
P130005|S001|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM|MCX|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/28/2014|10/29/2014|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO ENHANCE THE SAFETY OF THE DEVICE OR USE OF THE DEVICE.
P130030|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2014|08/19/2014|||OK30|UPGRADE TO THE MANUFACTURING EXECUTION SYSTEM (MES).
P080020|S010|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2014|08/28/2014|||OK30|UPDATE A TESTING SYSTEM.
P050038|S023|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/ FLEXITIP XL-R|LMG|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/29/2014|03/16/2015|||APPR|APPROVAL FOR THE LINE EXTENSION OF THE FLEXITIP XL APPLICATOR FAMILY TO INCLUDE THE FLEXITIP XL-R APPLICATOR. THE MODIFICATION IS BASED UPON THE CURRENT APPLICATOR DESIGN BUT NOW INCLUDES AN ADDITIONAL OUTER STAINLESS STEEL TUBING TO CREATE A RIGID (XL-R) PORTION OF THE APPLICATOR TIP. IN ADDITION, APPROVAL FOR REVISION OF THE INSTRUCTIONS FOR USE OF THE ARISTA AH PRODUCT LABELING IN ORDER TO INFORM USERS OF USE OF THE NEW APPLICATOR DURING ENDOSCOPIC/ LAPAROSCOPIC USES.
P120010|S031|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2014|08/28/2014|||OK30|CHANGE IN THE MANUFACTURING OF THE ENLITE¿ GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) TO MODIFY THE STERILIZATION PROCESS WITH RESPECT TO THE STERILIZATION DOSE AND BIOBURDEN ALERT AND ACTION LEVELS. THE ENLITE¿ GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P110035|S028|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2014|08/26/2014|||OK30|STENT COMPONENT SUB-PROCESS RELOCATION.
P840001|S279|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL 4, ITREL 4, ITREL 3, SYNERGY, SYNERGY VERSITREL|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2014|08/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER AND TO MAKE MANUFACTURING TOOLING CHANGES FOR A COMPONENT OF THE FEEDTHROUGH ASSEMBLY.
P010030|S056|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2013|12/17/2015|15M-3521|12/24/2015|APPR|APPROVAL FOR THE LIFEVEST WEARABLE CARDIOVERTER DEFIBRILLATOR, MODELS 3000, 3100, AND 4000. THE LIFEVEST SYSTEM IS INDICATED FOR PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. THE LIFEVEST SYSTEM ISINDICATED FOR PATIENTS UNDER 18 YEARS OF AGE WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.  PATIENTS MUST HAVE A CHEST CIRCUMFERENCE OF 26 INCHES (66 CENTIMETERS) OR GREATER AND A WEIGHT OF 18.75 KILOGRAMS (41.3 POUNDS) OR GREATER.
P050023|S078|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ILESTO/IFORIA 5 & 7 ICD/CRT-D FAMILIES|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/31/2014|10/10/2014|||APPR|APPROVAL FOR A MODIFIED DUMP RESISTOR FOR THE ILESTO/IFORIA FAMILIESOF ICDS/CRT-DS.
P020045|S059|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CRYOCONSOLE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/31/2014|10/01/2014|||APPR|APPROVAL TO UPDATE THE LEAK DETECTION FIRMWARE.
P080020|S011|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2014|08/28/2014|||OK30|USE NEWLY INSTALLED EQUIPMENT.
P960009|S200|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA SC, ACTIVA SC, KINETRA, SOLETRA|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2014|08/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER AND TO MAKE MANUFACTURING TOOLING CHANGES FOR A COMPONENT OF THE FEEDTHROUGH ASSEMBLY.
P970004|S181|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM, INTERSTIM II|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2014|08/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER AND TO MAKE MANUFACTURING TOOLING CHANGES FOR A COMPONENT OF THE FEEDTHROUGH ASSEMBLY.
P080025|S077|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM, INTERSTIM II|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2014|08/27/2014|||OK30|ADD AN ALTERNATE SUPPLIER AND TO MAKE MANUFACTURING TOOLING CHANGES FOR A COMPONENT OF THE FEEDTHROUGH ASSEMBLY.
N16837|S017|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2014|08/25/2014|||OK30|ALTERNATE SUPPLIER FOR THE BOVINE CAROTID ARTERY.
P080020|S012|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2014|08/28/2014|||OK30|USE NEWLY INSTALLED EQUIPMENT.
P950020|S068|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2014|08/29/2014|||OK30|CHANGE TO MOVE THE ELECTRICAL DISCHARGE MACHINING (EDM) PROCESS FOR A COMPONENT OF THE BSC FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE TO THE BSC MAPLE GROVE, MINNESOTA FACILITY.
P010031|S458|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2014|08/12/2014|||OK30|ADDITION OF FILL HOLE SEAL LASER WELDING EQUIPMENT.
P830055|S147|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/31/2014|08/29/2014|||APPR|APPROVAL FOR CHANGES TO THE LABELING FOR THE COMPUTER AIDED SURGICAL INSTRUMENTS SURGICAL TECHNIQUE, INCLUDING UPDATED ILLUSTRATIONS, CLARIFICATIONS OF SEVERAL STEPS IN THE TECHNIQUE, AND ADDITIONAL INSTRUCTIONS FOR OPTIONAL USE OF A LAMINA SPREADER TECHNIQUE FOR SOFTTISSUE BALANCING.
P080030|S011|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MIRCO-BYPASS STENT SYSTEM|OGO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/29/2014|||OK30|MODIFICATION TO THE ETCHING PROCESS CONSISTING OF THE CHANGES TO THE ETCHING TIME, ACID CONCENTRATION, BATCH SIZE, AND AGITATION METHOD.
P000006|S037|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/01/2014|08/13/2014|||APPR|APPROVAL FOR REVISIONS IN THE TITAN INSTRUCTIONS FOR USE TO HAVE PATIENTS WITH A DOCUMENTED SENSITIVITY TO SILICONE AS A CONTRAINDICATION INSTEAD OF BEING LISTED AS A WARNING.
P850007|S033|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM AND SPINAL-STIM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/27/2014|||OK30|PROCESS CHANGE FOR THE BONE GROWTH STIMULATOR DEVICES.
P030034|S007|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL-STIM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/27/2014|||OK30|PROCESS CHANGE FOR THE BONE GROWTH STIMULATOR DEVICES.
P840001|S280|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, PRIME ADVANCED, ITREL, AND SYNERGY FAMILIES OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/27/2014|||OK30|UPDATE AND IMPLEMENT A SERIAL NUMBER GENERATOR.
P120010|S032|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/01/2014|09/29/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P960040|S325|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERTICALLY INTEGRATING BATTERY FEEDTHRU ASSEMBLY|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/11/2014|||OK30|MANUFACTURE THE BATTERY FEEDTHRU SUBASSEMBLY AT THE ST. PAUL FACILITY FOR THE DEVICES.
P810025|S035|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|AMVISC AND AMVISC PLUS VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/29/2014|||OK30|ELIMINATION OF POST-FILL QUALITY CONTROL TESTS.
P020004|S103|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/22/2014|||OK30|ADD THE CAPABILITY FOR CATHETER COMPONENT MANUFACTURING AT AN ADDITIONAL INTERNAL FACILITY.
P010015|S246|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/13/2014|||OK30|USE A NEW SOFTWARE VERSION TO COLLECT MEASUREMENT AND PROCESS DATA AT THE HYBRID SUPPLIER.
P850022|S023|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2014|08/28/2014|||OK30|PCB BOARD AND SOFTWARE CHANGES.
P050023|S079|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IPERIA FAMILY ICD/CRT-D: IPERIA ITREVIA AND INVENTRA|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/2014|02/10/2015|||APPR|APPROVAL FOR THE INVENTRA, IPERIA AND ITREVIA ICD AND CRT-D DEVICES AS WELL AS UPDATES TO NON-IMPLANTED COMPONENTS RENAMIC, PSW 1401.U AND THE HOME MONITORING SERVICE CENTER TO SUPPORT THE INTRODUCTION OF THE NEW ICD AND CRT-D DEVICES.
P010031|S459|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/13/2014|||OK30|USE A NEW SOFTWARE VERSION TO COLLECT MEASUREMENT AND PROCESS DATA AT THE HYBRID SUPPLIER.
P090013|S151|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/13/2014|||OK30|USE A NEW SOFTWARE VERSION TO COLLECT MEASUREMENT AND PROCESS DATA AT THE HYBRID SUPPLIER.
P980016|S495|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICS, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/13/2014|||OK30|USE A NEW SOFTWARE VERSION TO COLLECT MEASUREMENT AND PROCESS DATA AT THE HYBRID SUPPLIER.
P980035|S388|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG,RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/13/2014|||OK30|USE A NEW SOFTWARE VERSION TO COLLECT MEASUREMENT AND PROCESS DATA AT THE HYBRID SUPPLIER.
P960009|S201|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATIORS|MHY|NE|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/29/2014|||APPR|APPROVAL FOR A VISUAL INSPECTION CHANGE FOR THE DBS BOOT COMPONENT IN THE DBS EXTENSION AND ACCESSORY KITS (MODELS 7482A, 7483, 37085, AND 37086).
P030011|S027|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/04/2014|09/12/2014|||APPR|APPROVAL FOR SEVERAL DESIGN CHANGES TO THE SYNCARDIA COMPANION 2DRIVER PRESSURE SENSOR PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND THE ADDITION OF AN ALTERNATE SUPPLIER FOR THE PRESSURE SENSOR PCBA.
P950037|S139|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/04/2014|02/10/2015|||APPR|APPROVAL FOR THE INVENTRA, IPERIA AND ITREVIA ICD AND CRT-D DEVICES AS WELL AS UPDATES TO NON-IMPLANTED COMPONENTS RENAMIC, PSW 1401.U AND THE HOME MONITORING SERVICE CENTER TO SUPPORT THE INTRODUCTION OF THE NEW ICD AND CRT-D DEVICES.
P960009|S202|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY FOR DEEP BRAIN STIMULATION -TREMOR CONTROL|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/27/2014|||OK30|UPDATE AND IMPLEMENT A SERIAL NUMBER GENERATOR.
P970004|S182|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/27/2014|||OK30|UPDATE AND IMPLEMENT A SERIAL NUMBER GENERATOR.
P080025|S078|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM IMPLANTABLE NEUROSTIMULATOR FOR BOWEL CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2014|08/27/2014|||OK30|UPDATE AND IMPLEMENT A SERIAL NUMBER GENERATOR.
P980016|S496|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/27/2014|||OK30|AUTOMATE THE IN-PROCESS BATTERY INSULATOR INSPECTION.
P010031|S460|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROCTECTA CRT-D,PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/27/2014|||OK30|AUTOMATE THE IN-PROCESS BATTERY INSULATOR INSPECTION.
P970031|S047|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/14/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P870078|S027|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/14/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P090016|S011|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|09/09/2014|||OK30|SAMPLING CHANGES DURING PRODUCT MANUFACTURE AND DURING FINAL RELEASE TESTING FOR THE BELOTERO BALANCE PRODUCT.
P980035|S389|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|08/29/2014|||OK30|MANUFACTURING TOOLING UPDATE AND AN ADDITIONAL SUPPLIER FOR THE INSULATOR SUBCOMPONENT OF THE FLAT TOP (FT) ASSEMBLY OF THE DEVICES.
P950029|S094|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|08/27/2014|||OK30|ALTERNATE THERMOSEALING EQUIPMENT TO PERFORM BLISTER SEALING OPERATION FOR PACEMAKERS AND DEFIBRILLATORS.
P050037|S054|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLERS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2014|09/02/2014|||OK30|SCALE-UP OF THE WASH PROCESS FOR COMPONENTS USED IN THE MANUFACTURE OF RADIESSE DERMAL FILLER.
P050052|S059|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLERS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2014|09/02/2014|||OK30|SCALE-UP OF THE WASH PROCESS FOR COMPONENTS USED IN THE MANUFACTURE OF RADIESSE DERMAL FILLER.
P120020|S005|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|09/02/2014|||OK30|REPLACEMENT OF OVENS USED FOR STENT MANUFACTURING.
P100010|S042|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT ADVANCE CRYOBALLOON CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/27/2014|||OK30|UPDATES TO THE QUALITY ASSURANCE FINAL INSPECTION (QA FINAL) AND FINAL HANDLE ASSEMBLY (P18) TO STREAMLINE THE MANUFACTURING FLOW, BALANCE THE WORKLOAD, AND REDUCE THE CYCLE TIME OF THE FINAL INSPECTION STEPS OF THE ARCTIC FRONT ADVANCE (AFA) CATHETERS.
P030053|S019|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL BREAST IMPLANT|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/04/2014|01/16/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: RE-OP PHASE PROTOCOL AS A NEW POST-APPROVAL STUDY REQUIREMENT.
P990064|S058|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSIAC PORCINE BIOPOROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/14/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P090016|S010|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|09/03/2014|||OK30|MANUFACTURING CHANGES TO THE CLEAN ROOM ASSOCIATED WITH THE MANUFACTURE OF THE BELOTERO BALANCE DERMAL FILLER.
P980043|S049|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/14/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P790007|S043|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/14/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P890003|S316|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|08/29/2014|||OK30|MANUFACTURING TOOLING UPDATE AND AN ADDITIONAL SUPPLIER FOR THE INSULATOR SUBCOMPONENT OF THE FLAT TOP (FT) ASSEMBLY OF THE DEVICES.
P960040|S326|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NG3 DEVICES: ORIGEN, INOGEN,  DYNAGEN ICDS; PROGENY DEVICES: PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|08/13/2014|||OK30|ADD A SECOND-TIER SUPPLIER FOR SILICON-CONTROLLED RECTIFIERS (SCRS) AND ANODE GATED THYRISTORS (AGTS).
P010012|S366|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES:  PUNCTUA , ENERGEN , & INCEPTA CRT-D'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|08/13/2014|||OK30|ADD A SECOND-TIER SUPPLIER FOR SILICON-CONTROLLED RECTIFIERS (SCRS) AND ANODE GATED THYRISTORS (AGTS).
P990074|S030|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/06/2014|11/04/2014|||APPR|APPROVAL FOR AN ALTERNATE MATERIAL FOR ONE COMPONENT USED IN THE FILL TUBE FOR NATRELLE SALINE-FILLED BREAST IMPLANTS.
P980049|S101|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR/DR 8750 & VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101 & Z102)|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2014|08/27/2014|||OK30|ALTERNATE THERMOSEALING EQUIPMENT TO PERFORM BLISTER SEALING OPERATION FOR PACEMAKERS AND DEFIBRILLATORS.
P060027|S068|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM CRT-D9750 (ZL102)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|08/27/2014|||OK30|ALTERNATE THERMOSEALING EQUIPMENT TO PERFORM BLISTER SEALING OPERATION FOR PACEMAKERS AND DEFIBRILLATORS.
P960016|S048|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC AND SAFIRE ABLATION CATHETERS|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|09/05/2014|||APPR|APPROVAL FOR ADDITION OF A NEW INSPECTION STEP TO THE PACKAGE SEALING AND STERILE PACKAGE ASSEMBLY MANUFACTURING PROCEDURES AND ADDITIONAL CLARIFICATIONS TO FINAL PACKAGE INSPECTION FOR SPECIFIC VISUAL INSPECTION PROCEDURE, INCLUDING AN INSPECTION STEP FOR DETECTING WRINKLES.
P000025|S080|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MAESTRO COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/06/2014|09/12/2014|||OK30|ALTERNATE ELECTRODE SUPPLIER.
P090016|S012|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2014|09/10/2014|||OK30|IMPLEMENTATION OF MONITORING OF RINSE WATER FROM THE CLEANING OF ITEMS USED DURING THE MANUFACTURE OF THE BELOTERO BALANCE DERMAL FILLER.
P880086|S246|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT, ACCENT RF, ENTITY, IDENTITY, IDENTITY ADX, IDENTITY XL, SUSTAIN XL, VERITY ADX XL, VERITY ADX XL M/S, VERITY ADX|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2014|09/04/2014|||OK30|ALTERNATE SUPPLIER FOR THE HYBRID ASSEMBLY DIE COAT MATERIAL FOR THE DEVICES.
P030035|S124|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ANTHEM RF, FRONTIER, FRONTIER II|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2014|09/04/2014|||OK30|ALTERNATE SUPPLIER FOR THE HYBRID ASSEMBLY DIE COAT MATERIAL FOR THE DEVICES.
P100023|S104|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- MONORAIL AND ION PACLITAXEL-ELUTING CORONAY STENT SYSTEM- OVER THE WIRE|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/07/2014|01/21/2015|||APPR|APPROVAL FOR A REVISED LABELING UPDATE FOR THE TAXUS PERSEUS WORKHORSE (WH) AND SMALL VESSEL (SV) 5-YEAR STUDY PER POST-APPROVAL COMMITMENT #1.
P120006|S015|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT|MIH|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/2014|02/02/2015|||APPR|APPROVAL THE TO ADD A LARGER DIAMETER ILIAC LIMB AND ILIAC EXTENSION, A LONGERLENGTH ILIAC LIMB, AND DECREASE THE DELIVERY SYSTEM PROFILE FOR EACH ILIAC LIMB AND ILIAC EXTENSIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OVATION PRIMEABDOMINAL STENT GRAFT SYSTEM WITH THE OVATION IX ILIAC STENT GRAFT AND IS INDICATED FOR THETREATMENT OF PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS HAVING THE VASCULAR MORPHOLOGY SUITABLEFOR ENDOVASCULAR REPAIR, INCLUDING:1)	ADEQUATEILIAC/FEMORAL ACCESS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES (FEMORALCUTDOWN OR PERCUTANEOUS), DEVICES AND/OR ACCESSORIES;2) PROXIMAL AORTIC LANDING ZONE:A) WITH AN INNER WALL DIAMETER OF NO LESS THAN 16 MM AND NO GREATER THAN 30 MM AT 13MM BELOW THE INFERIOR RENAL ARTERY, AND B) WITH AN AORTIC ANGLE OF < 60 DEGREES IF PROXIMAL NECK IS 10 ¿ MM DEGREES IF PROXIMAL NECK IS < 10 MM; AND 3)  DISTAL ILIAC LANDING ZONE:A) WITH A LENGTH OF AT LEAST 10 MM, ANDB) WITH AN INNER WALL DIAMETER OF NO LESS THAN 8 MM AND NO GREATER THAN 25 MM.
P950029|S095|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/27/2014|||OK30|CHANGES ON THE ELECTRONIC ASSEMBLY LINE FOR AN UPDATE TO IN-PROCESS STEPS.
P080011|S031|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILLIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|09/09/2014|||OK30|REPLACEMENT OF THE FEDEGARI THERMA 3 FOAF3 AUTOCLAVE (FEDEGARI W) WITH THERMA 4 FOAF3/A FEDEGARI AUTOCLAVE (FEDEGARI F).
P030032|S017|GENZYME BIOSURGERY|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||Implant, dermal, for aesthetic use|PREVELLE SILK|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|09/05/2014|||OK30|ADDITION OF ENDOTOXIN TESTING TO THE PURIFIED WATER RAW MATERIAL SPECIFICATION.
P850079|S067|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY (METHAFILCON A AND B) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|09/09/2014|||OK30|REPLACEMENT OF THE FEDEGARI THERMA 3 FOAF3 AUTOCLAVE (FEDEGARI W) WITH THERMA 4 FOAF3/A FEDEGARI AUTOCLAVE (FEDEGARI F).
P110043|S007|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|09/05/2014|||OK30|ADDITION OF AN ALTERNATE TEST METHOD FOR A MATERIAL COMPONENT.
P090029|S001|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE (R) LP CERVICAL DISC|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/08/2014|04/06/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010015|S247|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, LED VENTRICULAR PACING LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P030036|S073|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P060039|S061|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MODEL 4195 ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P080006|S070|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P090013|S152|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P100047|S049|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/2014|10/16/2014|||APPR|APPROVAL FOR CHANGING THE HEAT SEAL ADHESIVE COATING ON THE INNER AND OUTER TRAYS OF THE IMPLANT KIT/ IMPLANT ACCESSORIES AND SURGICAL TOOLS.
P910056|S018|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2014|09/10/2014|||OK30|ACCEPTANCE OF AN ALTERNATE CYTOTOXICITY TESTING LAB.
P830061|S113|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P850089|S110|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P890003|S317|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P920015|S138|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P930039|S115|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, MODEL 4195 ATTAIN SUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P980050|S094|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|08/29/2014|||OK30|UPDATE TO THE FINAL PACKAGING LINE FOR THE DEVICES.
P960040|S328|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN, PUCTUA, DYNAGEN, INOGEN, ORIGEN; CRT-D'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2014|08/27/2014|||OK30|MODIFY A VACUUM BAKE PROCESS.
P040046|S008|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/11/2014|11/07/2014|||APPR|APPROVAL FOR ADDITIONAL NATRELLE 410 DEVICE STYLES AND SIZES INCLUDING: ONE (1) SIZE OF STYLE FL 410; ONE (1) SIZE OF STYLE ML 410; TWO (2) SIZES OF STYLE LL 410; FOUR (4) SIZES OF STYLE LM 410; TEN (10) SIZES OF STYLE LF 410; NINE (9) SIZES OF STYLE FX 410; NINE (9) SIZES OF STYLE MX 410; AND SEVEN (7) SIZES OF STYLE LX 410.
P010012|S368|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, ORIGEN; ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2014|08/27/2014|||OK30|MODIFY A VACUUM BAKE PROCESS.
P130021|S006|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2014|09/09/2014|||OK30|CHANGE TO BIOBURDEN TESTING METHODS.
P130005|S002|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/11/2014|02/12/2015|||APPR|APPROVAL FOR CHANGES TO THE DESIGN OF THE ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP MODEL SIP-3000) INCLUDING THE ADDITION OF A SECONDARY MOTOR FEEDBACK PRINTED CIRCUIT BOARD, THE ADDITION OF A SHROUD OVER THE AC POWER CORD CONNECTION, THE ADDITION OF A 100% INSPECTION OF POWER JACK RETENTION, AND THE SELECTION OF AN ALTERNATE VENDOR FOR THE TIMER COMPONENT.
P980022|S160|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2014|10/08/2014|||APPR|APPROVAL FOR A CHANGE TO A SUPPLIER¿S PRODUCTION LINE FOR A MOTOR PART OF THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K,MMT-723 AND MMT-723K) AND THE MINIMED 530G INSULIN PUMPS (MODELS MMT-551 AND MMT-751). THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM, PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE MINIMED 530G SYSTEM RESPECTIVELY.
P120010|S033|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2014|10/08/2014|||APPR|APPROVAL FOR A CHANGE TO A SUPPLIER¿S PRODUCTION LINE FOR A MOTOR PART OF THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K,MMT-723 AND MMT-723K) AND THE MINIMED 530G INSULIN PUMPS (MODELS MMT-551 AND MMT-751). THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM, PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE MINIMED 530G SYSTEM RESPECTIVELY.
P910001|S073|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2014|08/21/2014|||OK30|ADDING ALTERNATE SUPPLIERS FOR A CAPACITOR COMPONENT OF THE CVX-300 AND CVX-300-P LASER SYSTEMS.
P960009|S203|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA IMPLANTABLE NEUROSTIMULATORS|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/11/2014|10/24/2014|||APPR|APPROVAL FOR A MATERIAL CHANGE TO THE WHITE DBS BOOT.
P110042|S040|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2014|08/27/2014|||OK30|MANUFACTURING PROCESS CHANGE TO IMPROVE AN INSPECTION STEP.
P020045|S060|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATH.&  XTRA SURGICAL DEVICE, 9F FREEZOR MAX SURGICAL CATH CATHRYOCONSOLE SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/11/2014|10/23/2014|||APPR|APPROVAL FOR A MODIFIED CHECK VALVE IN THE CRYOCONSOLE.
P100025|S007|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)|OZA|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/2014|02/03/2015|||APPR|APPROVAL FOR CAMBRIDGE ISOTOPE LABORATORIES, INC. (CIL'S) AMENDED DRUG MASTER FILE (DMF) #11378 ON BEHALF OF OAPI'S PMA APPLICATION WHICH USES THE DRUG AS A COMPONENT OF THE BREATHTEK UBT FOR H. PYLORI KIT. THIS SUPPLEMENT REQUESTS THE REVIEW OF THE FOLLOWING CHANGES TO THE DRUG MASTER FILE:1. PROCESS CHANGE TO MANUFACTURING SCALE TO ADD 18KG PROCESS;2. UPDATE TO SPECIFICATIONS AND TEST METHODS FOR 13C-UREA;3. CHANGES IN QC TESTING LOCATIONS; AND 4. CHANGES IN MANUFACTURING LOCATIONS FOR 18KG PROCESS.
P050027|S007|KARL STORZ ENDOSCOPY-AMERICA, INC.|2151 E. GRAND AVE.||EL SEGUNDO|CA|90245||Light source system, diagnostic endoscopic|KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM|OAY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2014|09/09/2014|||OK30|REPLACE THE ORIGINAL CARD-EDGE CONNECTOR WITH A NEW CARD-EDGE CONNECTOR.
P040045|S047|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2014|09/05/2014|||OK30|MODIFICATION OF A TEST METHOD FOR LEACHABLE COMPONENTS.
P090013|S153|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2014|09/03/2014|||OK30|ADDITION OF A VISUAL VERIFICATION SYSTEM TO ENSURE THAT THE CORRECT INNER TRAY IS BEING USED FOR PACKAGING LEADS AND ACCESSORIES.
P830061|S114|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2014|09/03/2014|||OK30|ADDITION OF A VISUAL VERIFICATION SYSTEM TO ENSURE THAT THE CORRECT INNER TRAY IS BEING USED FOR PACKAGING LEADS AND ACCESSORIES.
P930039|S116|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2014|09/03/2014|||OK30|ADDITION OF A VISUAL VERIFICATION SYSTEM TO ENSURE THAT THE CORRECT INNER TRAY IS BEING USED FOR PACKAGING LEADS AND ACCESSORIES.
P980050|S095|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2014|08/27/2014|||OK30|OUTSOURCE TWO MOLDED COMPONENTS.
P920015|S139|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2014|08/27/2014|||OK30|OUTSOURCE TWO MOLDED COMPONENTS.
P950024|S062|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2014|09/03/2014|||OK30|OUTSOURCE THE MANUFACTURE OF THE ELECTRODE INSULATOR USED IN THE CAPSURE EPICARDIAL PACING LEAD.
P010013|S059|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM/ ABLATION SYSTEM WITH SURESOUND UTERINE SOUND|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2014|09/09/2014|||OK30|STERILIZATION PROCESS CHANGE TO REDUCE THE AERATION TIME IN THE STERILIZATION PROCESS.
P960040|S329|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN ICD, INOGEN ICD, DYNAGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2014|09/04/2014|||OK30|CHANGE IN A QUALITY CONTROL INSPECTION TEST LIMIT FOR THE HIGH VOLTAGE CAPACITOR.
P960040|S330|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN, INOGEN, DYNAGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2014|09/10/2014|||OK30|IMPLEMENT THE ASYS LASER MARK SYSTEM.
P030031|S060|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2014|09/12/2014|||OK30|MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP.
P010012|S369|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2014|09/10/2014|||OK30|IMPLEMENT THE ASYS LASER MARK SYSTEM.
P040036|S045|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2014|09/12/2014|||OK30|MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP.
P950005|S052|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS FLTR UNI-DIRECTIONAL CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2014|09/12/2014|||OK30|MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP.
P010068|S041|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS FLTR BI-DIRECTIONAL CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2014|09/12/2014|||OK30|MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP.
P910077|S146|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX & VENTAK MINI ICD: LATTITUDE PATIENT MANAGMENT SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2014|09/05/2014|||OK30|USE OF AN EXISTING SURFACE MOUNT TECHNOLOGY MANUFACTURING LINE AS AN ALTERNATE TO PRODUCE PRINTED CIRCUIT ASSEMBLIES.
P890003|S318|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON BRILLIANT S+ VDD LEAD|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2014|09/30/2014|||APPR|APPROVAL FOR USE OF NEW SILICONE INSULATION TUBING MATERIALS.
P860004|S211|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC SYNCHROMED II INFUSION SYSTEMS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2014|09/12/2014|||OK30|REPLACEMENT OF THE CURRENT FINAL FUNCTION TEST (FFT) SOFTWARE VERSION WITH A NEW SOFTWARE REVISION.
P980016|S497|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S D DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2014|09/10/2014|||OK30|NEW CASE TO COVER WELDER MACHINE AT MECC TO INCREASE MANUFACTURING CAPACITY FOR THE DEVICES.
P010031|S461|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA  & QUAD CRT-DS, VIVA QUAD S &  XT CRT-DS, VIVA S &  XT CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2014|09/10/2014|||OK30|NEW CASE TO COVER WELDER MACHINE AT MECC TO INCREASE MANUFACTURING CAPACITY FOR THE DEVICES.
P950039|S029|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THIN PREP PROCESSORS|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2014|09/12/2014|||OK30|THE FOLLOWING TEN CHANGES: QUALITY CONTROL (QC) INSTRUCTIONS FOR MICROSCOPE SLIDES INK AND CHIP, ADD A NEW FRICTION FEEDER EQUIPMENT, TP-00372 DOCUMENTATION UPDATE, ELECTRICAL SAFETY TESTING, TRANSFER OF LEGACY (LEGACY PMR) DOCUMENTATION INTO AGILE DOCUMENT CONTROL SYSTEM, INSTRUCTION CLARIFICATION REGARDING AIR VENT HOLES DURING MACHINE ASSEMBLY, MECHANICAL DRIVER BOARDS TESTING, PRESERVCYT QC TESTING, CHANGE IN OWNERSHIP OF LCD BOARD MANUFACTURER, AND IMPROVEMENT TO FIXTURES USED IN THE SCREEN PRINTING PROCESS (SQUEEGEE).
P980035|S390|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2014|09/10/2014|||OK30|CHANGES TO THE PROTEUS TEST SYSTEM WHICH IS USED FOR ELECTRICAL TESTING OF FULLY ASSEMBLED DEVICES.
P010031|S462|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2014|09/12/2014|||OK30|REDUCE THE FREQUENCY OF CAPACITOR WELD MONITORING FOR THE DEVICES.
P970053|S014|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EXCIMER LASER SYSTEM EC-5000|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/2014|11/14/2014|||APPR|APPROVAL FOR A NEW 200 HZ EYETRACKER, WHICH REPLACES THE EXISTING 200 HZ EYETRACKER USED WITH THE EC-5000 EXCIMER LASER. THIS CHANGE ALSO INCLUDES MODIFICATION TO THE ASSOCIATED CAMERA AND SOFTWARE AS WELL AS THE IR ILLUMINATION.
P980016|S498|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2014|09/12/2014|||OK30|REDUCE THE FREQUENCY OF CAPACITOR WELD MONITORING FOR THE DEVICES.
P120016|S004|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/18/2014|11/06/2014|||APPR|APPROVAL FOR A CHANGE TO THE JOINT OF THE SUPPORT AND CORE TUBES.
P120016|S005|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2014|01/12/2015|||APPR|APPROVAL FOR A CHANGE TO THE CHRONOPRENE MEMBRANE AND CUT-TOLENGTH EQUIPMENT.
P980037|S043|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET FAMILY OF THROMBECTOMY SETS|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2014|09/04/2014|||OK30|ALTERNATE COMPONENT VENDOR FOR THE LOW PRESSURE PUMP SEAL.
P810031|S051|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS, HEALON ULTIMATE DUAL|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2014|10/08/2014|||OK30|REPLACEMENT OF THE QUALITY CONTROL SODIUM CHLORIDE TEST WITH AN OSMOLALITY TEST IN THE MANUFACTURING OF HEALON® PRODUCTS.
P040050|S011|UROPLASTY, LLC|5420 FELTL ROAD||MINNETONKA|MN|55343||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|MACROPLASTIQUE IMPLANTS|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2014|09/16/2014|||OK30|ADDITION OF AN ALTERNATIVE BACTERIAL ENDOTOXIN TESTING FACILITY.
P980035|S391|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA, ENPULSE E1/E2. KAPPA D/DR/VDD IPG'S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2014|11/07/2014|||APPR|APPROVAL FOR AN UPDATE TO YOUR CARELINK AND CARELINK EXPRESSMONITOR FIRMWARE AND SOFTWARE TO IMPROVE THE SUPERIMPOSED DUAL EGM REPORTING.
P890003|S319|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODELS 2490H CARELINK REMOTE HOME MONITOR, 2020C CARELINK EXPRESS MONITOR, AND 2491 DDMA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2014|11/07/2014|||APPR|APPROVAL FOR AN UPDATE TO YOUR CARELINK AND CARELINK EXPRESSMONITOR FIRMWARE AND SOFTWARE TO IMPROVE THE SUPERIMPOSED DUAL EGM REPORTING.
P840001|S281|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2014|09/15/2014|||OK30|CHANGES TO THE THERMAL SHOCK CYCLING PROCESS.
P960009|S204|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2014|09/15/2014|||OK30|CHANGES TO THE THERMAL SHOCK CYCLING PROCESS.
P110013|S044|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/20/2014|10/20/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P850035|S038|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2014|09/19/2014|||OK30|ADDITIONAL OF AN ALTERNATE COMPONENT SUPPLIER.
P790005|S051|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2014|09/19/2014|||OK30|ADDITIONAL OF AN ALTERNATE COMPONENT SUPPLIER.
P960040|S331|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2014|09/18/2014|||OK30|VERTICALLY INTEGRATE THE MANUFACTURE OF THE FEEDTHRU FERRULES FOR THE BATTERIES USED IN THE DEVICES.
P010012|S370|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2014|09/18/2014|||OK30|VERTICALLY INTEGRATE THE MANUFACTURE OF THE FEEDTHRU FERRULES FOR THE BATTERIES USED IN THE DEVICES.
P080006|S071|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/18/2014|||OK30|UPDATE TO THE COMPONENT AND LEAD DRAWINGS FOR THE RING MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) COMPONENT, AND THE CORRESPONDING MANUFACTURING PROCESSES, TO INCLUDE ADDITIONAL INSPECTION CRITERIA.
P110023|S012|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/22/2014|04/29/2015|||APPR|APPROVAL TO ADD THE 5F ENTRUST OTW DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM AND IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 140MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.5-7.5MM.
P910023|S343|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FORTIFY, FORTIFY ASSURA FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/22/2014|11/20/2014|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE BATTERY HEADER IN THE BATTERIES UTILIZED IN THE DEVICES.
P090007|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/19/2014|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR A BULK SOLUTION FORMULATION.
P090008|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 602|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/19/2014|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR A BULK SOLUTION FORMULATION.
P090009|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E 170|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/19/2014|||OK30|CHANGE IN THE MANUFACTURING PROCESS FOR A BULK SOLUTION FORMULATION.
P030054|S274|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/22/2014|11/20/2014|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE BATTERY HEADER IN THE BATTERIES UTILIZED IN THE DEVICES.
P060039|S062|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC 4195 ATTAIN STARFIX MODEL 4195 LV LEAD|NVY|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/22/2014|09/12/2014|||APPR|APPROVAL OF THE REQUEST TO CLOSE THE CHRONIC EXTRACTION POST-APPROVAL STUDY FOR THE DEVICE.
P980016|S499|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/12/2014|||OK30|SECOND SOURCE SUPPLIER FOR THE TRANSFORMER SHIELD.
P100023|S105|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/12/2014|||OK30|CHANGES TO THE INSPECTION OF INNER SUBASSEMBLIES ON THE STENT DELIVERY CATHETERS.
P110010|S092|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM & PROMUS PREMIER EVEROLIMUS-ELUTING PLATI|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/12/2014|||OK30|CHANGES TO THE INSPECTION OF INNER SUBASSEMBLIES ON THE STENT DELIVERY CATHETERS.
P090029|S002|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE(R) LP CERVICAL DISC|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/22/2014|03/11/2016|||APPR|Approval of the post-approval study protocol.
P130030|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/12/2014|||OK30|CHANGES TO THE INSPECTION OF INNER SUBASSEMBLIES ON THE STENT DELIVERY CATHETERS.
P010031|S463|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUADA CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2014|09/12/2014|||OK30|SECOND SOURCE SUPPLIER FOR THE TRANSFORMER SHIELD.
P850064|S027|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|08/25/2014|02/13/2015|||APPR|APPROVAL FOR A NEW PATIENT BOX FOR THE DEVICE.
P850048|S038|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA ASSAY|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|12/23/2014|||APPR|APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).
P970038|S027|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|12/23/2014|||APPR|APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).
P980041|S028|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP IMMUNOASSAY SYSTEM|LOK|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|12/23/2014|||APPR|APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).
P090026|S012|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|12/23/2014|||APPR|APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).
P980041|S029|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2014|10/24/2014|||APPR|APPROVAL FOR THE ACCESS SUBSTRATE BOTTLE AND CAP.
P970038|S028|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2014|10/24/2014|||APPR|APPROVAL FOR THE ACCESS SUBSTRATE BOTTLE AND CAP.
P090026|S013|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2014|10/24/2014|||APPR|APPROVAL FOR THE ACCESS SUBSTRATE BOTTLE AND CAP.
P850048|S039|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2014|10/24/2014|||APPR|APPROVAL FOR THE ACCESS SUBSTRATE BOTTLE AND CAP.
P950020|S069|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2014|09/11/2014|||OK30|IMPLEMENT AN INSPECTION PROTOCOL OF THE BALLOON PROTECTOR COMPONENT OF THE FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE.
P040001|S022|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||Prosthesis, spinous process spacer/plate|X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/26/2014|10/24/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100023|S106|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2014|09/11/2014|||OK30|CHANGES TO OPTIMIZE THE OVER-THE-WIRE (OTW) CATHETER INSPECTION PROCESS.
P110010|S093|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT  PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2014|09/11/2014|||OK30|CHANGES TO OPTIMIZE THE OVER-THE-WIRE (OTW) CATHETER INSPECTION PROCESS.
P960016|S049|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC AND SAFIRE BIDIRECTIONAL ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2014|11/06/2014|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE SOLDER FOR THE APPROVED LIVEWIRE TC AND SAFIRE BIDIRECTIONAL ABLATION CATHETERS.
P020027|S021|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION VISTA FPSA  FLEX REAGENT CARTRIDGE|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/25/2014|||OK30|ADDITION OF AN ALTERNATE AUTOMATED COLUMN (INTERCHIM PURIFLASH® PURIFICATION SYSTEM) PURIFICATION PROCEDURE TO THE EXISTING MANUAL COLUMN CHROMATOGRAPHY PURIFICATION PROCEDURE IN THE EUROPIUM PARTICLE RAW MATERIAL (EPRM) MANUFACTURING PROCESS.
P000021|S026|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/25/2014|||OK30|ADDITION OF AN ALTERNATE AUTOMATED COLUMN (INTERCHIM PURIFLASH® PURIFICATION SYSTEM) PURIFICATION PROCEDURE TO THE EXISTING MANUAL COLUMN CHROMATOGRAPHY PURIFICATION PROCEDURE IN THE EUROPIUM PARTICLE RAW MATERIAL (EPRM) MANUFACTURING PROCESS.
P090013|S154|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2014|11/07/2014|||APPR|APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
P890003|S320|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2014|11/07/2014|||APPR|APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
P980016|S500|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD, INTRINSIC ICD, MARQUIS ICD,MARQUIS V|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2014|11/07/2014|||APPR|APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
P980035|S392|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2014|11/07/2014|||APPR|APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
P010015|S248|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2014|11/07/2014|||APPR|APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
P010031|S464|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, INSYNC III MARQUI|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2014|11/07/2014|||APPR|APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
P000037|S037|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/27/2014|02/09/2015|||APPR|APPROVAL FOR MODIFIED DEVICE PACKAGING AND AN EXTENSION TO THE PRODUCT SHELF LIFE.
P090013|S155|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|INCREASE IN THE STAGING DURATION FOR THE SLEEVEHEADS, COUPLERS, AND RETAINERS AND FOR THE USAGE OF AN UNHEATED HEPTANE BATH INSTEAD OF A HEATED HEPTANE BATH.
P930039|S117|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|INCREASE IN THE STAGING DURATION FOR THE SLEEVEHEADS, COUPLERS, AND RETAINERS AND FOR THE USAGE OF AN UNHEATED HEPTANE BATH INSTEAD OF A HEATED HEPTANE BATH.
P010015|S249|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD, CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P010031|S465|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D, PROTECTA XT CRT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P030036|S074|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P060039|S063|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P120012|S004|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REAL TIME HCV GENOTYPE II|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2014|09/25/2014|||OK30|MANUFACTURING PROCESS CHANGES AND IN-PROCESS QUALITY CONTROL METHOD CHANGES TO SYNTHESIZE OLIGONUCLEOTIDES ON A LARGER SCALE.
P890003|S321|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD2, CARELINK PROGRAMMER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P900061|S131|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P920015|S140|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P930029|S046|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONTACTR, RF ENHANCR II, RF MARINR, RF MARINR UNIPOLAR, RF CONDUCTR CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P950024|S063|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P980016|S501|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA , VIRUOSO II DR/VR ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P850089|S111|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P980035|S393|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P930039|S118|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, TORQUE CLIP DEVICE-ACCESSO|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P980050|S096|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P830061|S115|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P820003|S131|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER, MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P090013|S156|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD, REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P080006|S072|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD, ATTAIN PERFORMA QUADRIPOLAR LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|09/24/2014|||OK30|USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P060037|S031|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2014|07/02/2015|||APPR|APPROVAL FOR CHANGE IN STORAGE CONDITIONS, AND A CHANGE IN SHELF LIFE OF POLYETHYLENE BAR STOCK.
P110043|S008|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|10/09/2014|||OK30|CHANGE TO THE PYROGEN TESTING PROCESS.
P020047|S059|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|ML8 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|10/09/2014|||OK30|CHANGE TO THE PYROGEN TESTING PROCESS.
P070015|S124|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|10/09/2014|||OK30|CHANGE TO THE PYROGEN TESTING PROCESS.
P110019|S071|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) AND XIENCE XPEDITION EVEROLIMUS ELUTI|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2014|10/09/2014|||OK30|CHANGE TO THE PYROGEN TESTING PROCESS.
P020056|S026|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/29/2014|02/25/2015|||APPR|APPROVAL FOR A LINE EXTENSION IDENTIFIED AS THE NATRELLE INSPIRA SILICONE-FILLED BREAST IMPLANTS TO ADD BREAST IMPLANT OPTIONS TO THE NATRELLE SILICONE-FILLED BREAST IMPLANTS.
P120020|S006|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2014|01/09/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR, IN  TEMECULA, CALIFORNIA.
P020045|S061|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2014|09/25/2014|||OK30|ADDITIONAL CONTROLLED ENVIRONMENT AREA (CEA) AT THE MEDTRONIC CRYOCATH MONTREAL FACILITY (POINTE-CLAIRE BUILDING).
P100010|S043|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT, ARCTIC FRONT ADVANCED, AND FREEZOR MAX CARDIAC CRYOABLATION CATHETERS|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2014|09/25/2014|||OK30|ADDITIONAL CONTROLLED ENVIRONMENT AREA (CEA) AT THE MEDTRONIC CRYOCATH MONTREAL FACILITY (POINTE-CLAIRE BUILDING).
P980044|S019|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2014|09/26/2014|||OK30|REPLACEMENT OF A BACK-UP TEST SYSTEM USED DURING MANUFACTURING.
P950039|S030|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSORS|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/29/2014|09/26/2014|||APPR|APPROVAL FOR CLARIFICATIONS TO MANUFACTURING INSTRUCTIONS AND ADDITION OF SAFETY WARNINGS TO LABELING.
P030017|S203|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/02/2014|10/02/2014|||APPR|APPROVAL FOR A LABELING CHANGE TO BE MADE TO THE PRECISION AND PRECISION SPECTRA MANUALS. THE REQUESTED CHANGE ADDS SUPPLEMENTAL INFORMATION TO THE ADVERSE EVENTS SECTION OF THE MANUALS IN ORDER TO PROVIDE ADDITIONAL DETAILS ON THE POSSIBILITY OF THE FORMATION OF REACTIVE TISSUE AROUND THE LEAD IN THE EPIDURAL SPACE WHICH MAY RESULT IN DELAYED ONSET OF SPINAL CORD COMPRESSION AND NEUROLOGICAL/SENSORY DEFICIT INCLUDING PARALYSIS.
P020045|S062|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2014|10/01/2014|||OK30|ALTERNATE SUPPLIER TO MEDTRONIC CRYOCATH FOR THE ELECTRICAL CABLE SUBASSEMBLIES FOR THE ARCTIC FRONT ADVANCE/FREEZOR AND THE ELECTRICAL UMBILICAL CABLE.
P100010|S044|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCED CRYOBALLOON CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2014|10/01/2014|||OK30|ALTERNATE SUPPLIER TO MEDTRONIC CRYOCATH FOR THE ELECTRICAL CABLE SUBASSEMBLIES FOR THE ARCTIC FRONT ADVANCE/FREEZOR AND THE ELECTRICAL UMBILICAL CABLE.
P130005|S003|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK  360 CORONARY ORBITAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2014|09/26/2014|||OK30|CHANGE TO THE INCOMING QUALITY CONTROL INSPECTION FOR THE SALINE SHEATH ON THE ORBITAL ATHERECTOMY DEVICE (OAD).
P010031|S466|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|, BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/2014|11/14/2014|||APPR|APPROVAL FOR THE DESIGN AND MANUFACTURING CHANGES OF THE 9-PIN FEEDTHROUGH SUBASSEMBLY IN THE PMA SUPPLEMENTS.
P980016|S502|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR & SR,, EVERA XT DR  & VR , MAXIMO II, PROTECTA , PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/02/2014|11/14/2014|||APPR|APPROVAL FOR THE DESIGN AND MANUFACTURING CHANGES OF THE 9-PIN FEEDTHROUGH SUBASSEMBLY IN THE PMA SUPPLEMENTS.
N16895|S096|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2014|10/02/2014|||OK30|ADDITION OF AN ALTERNATE AUTOCLAVE FOR TERMINALLY STERILIZING SOFLENS® CONTACT LENSES.
P130009|S009|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS NOVAFLEX+ DELIVERY SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2014|09/30/2014|||OK30|REDUCE THE POST-STERILIZATION AMBIENT AERATION HOLD TIME FOR THE EDWARDS NOVAFLEX+ DELIVERY SYSTEM AND THE EDWARDS ASCENDRA+ DELIVERY SYSTEM.
P110043|S009|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2014|09/30/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER SITE FOR DEVICE COMPONENTS.
P010031|S467|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO II CRT-D, CONCULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/2014|10/02/2014|||APPR|APPROVAL FOR A BATTERY DESIGN CHANGE AND ASSOCIATED INSPECTION ANDPRODUCTION TOOLING CHANGES.
P980016|S503|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/2014|10/02/2014|||APPR|APPROVAL FOR A BATTERY DESIGN CHANGE AND ASSOCIATED INSPECTION ANDPRODUCTION TOOLING CHANGES.
P130009|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2014|09/29/2014|||OK30|ADDITION OF A NEW CLEAN ROOM AND EQUIPMENT.
P910073|S128|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/03/2014|11/04/2014|||APPR|APPROVAL FOR THE ACUITY X4 CONNECTOR TOOL MODEL 4625 ACCESSORY.
P030011|S029|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART  (TAH-T) SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2014|09/29/2014|||OK30|MANUFACTURING TRANSFER OF VARIOUS INJECTION MOLDED PARTS BELONGING TO THE FREEDOM DRIVER TO A NEW SUPPLIER.
P960040|S332|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN EL, INOGEN EL, ORIGEN EL ICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/2014|11/07/2014|||APPR|APPROVAL FOR THE BATTERY FEEDTHRU MODIFICATIONS OF THE DEVICES.
P010012|S371|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 CRT-D|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/03/2014|11/07/2014|||APPR|APPROVAL FOR THE BATTERY FEEDTHRU MODIFICATIONS OF THE DEVICES.
P080027|S018|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/03/2014|10/02/2014|||APPR|APPROVAL FOR THE ADDITION OF AN IN-PROCESS INSPECTION AS PART OF THE POUCHING PROCESS FOR THE ORAQUICK HCV RAPID ANTIBODY TEST.
P100021|S040|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT AND ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILAIAC (AUI) STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2014|10/03/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE SECONDARY AND TERTIARY PACKAGING FOR ENDURANT AND ENDURANT II STENT GRAFT SYSTEMS. ADDITIONALLY, A CHANGE IN CONFIGURATION FOR THE E-BEAM STERILIZATION PROCESS.
P120010|S034|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/02/2014|||OK30|NEW LASER SYSTEM BE ADDED TO THE SENSOR FABRICATION PROCESS FOR THE ENLITE SENSOR (MMT-7708), A COMPONENT OF THE MINIMED 530G SYSTEM.
P840001|S282|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|10/08/2014|||OK30|IMPLEMENTATION AN ELECTRONIC CONTINUOUS MONITORING SYSTEM IN THE MANUFACTURING AREAS.
N16837|S018|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/02/2014|||OK30|ALTERNATE SUPPLIER OF A CRITICAL PROCESS COMPONENT.
P860004|S212|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|10/08/2014|||OK30|IMPLEMENTATION AN ELECTRONIC CONTINUOUS MONITORING SYSTEM IN THE MANUFACTURING AREAS.
P960009|S205|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|10/08/2014|||OK30|IMPLEMENTATION AN ELECTRONIC CONTINUOUS MONITORING SYSTEM IN THE MANUFACTURING AREAS.
P970004|S183|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|10/08/2014|||OK30|IMPLEMENTATION AN ELECTRONIC CONTINUOUS MONITORING SYSTEM IN THE MANUFACTURING AREAS.
P110041|S001|SIEMENS CORP.|511 Benedict Avenue||Tarrytown|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAGII ASSAY|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/02/2014|02/02/2015|||APPR|VAPPROVAL FOR AN ADDITIONAL SURFACTANT TO THE LITE REAGENT.APPROVAL FOR AN ADDITIONAL SURFACTANT TO THE LITE REAGENT.
P080025|S079|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2014|10/08/2014|||OK30|IMPLEMENTATION AN ELECTRONIC CONTINUOUS MONITORING SYSTEM IN THE MANUFACTURING AREAS.
P860057|S128|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT MITRA & AORTIC,THEON,RSR,THEON RSR,MAGNA,MAGNA EASE WITH& WITHOUT THERMAFEX TISSUE PROCESS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/02/2014|||OK30|CHANGE FROM PORCINE TO BOVINE TISSUE IN THE POST-STERILIZATION TESTING.
P100041|S058|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/02/2014|||OK30|CHANGE FROM PORCINE TO BOVINE TISSUE IN THE POST-STERILIZATION TESTING.
P110021|S044|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/02/2014|||OK30|CHANGE FROM PORCINE TO BOVINE TISSUE IN THE POST-STERILIZATION TESTING.
P120010|S035|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2014|10/02/2014|||OK30|MODIFICATION OF DRAWING SPECIFICATIONS FOR THE SENSOR PATCH USED WITH THE ENLITE SENSOR (MMT-7008) AND THE ADDITION OF ANOTHER INSPECTION MEASUREMENT. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P130009|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/02/2014|||OK30|CHANGE FROM PORCINE TO BOVINE TISSUE IN THE POST-STERILIZATION TESTING.
P910077|S147|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Pacemaker/icd/crt non-implanted components|LATITUDE CONSULT SYSTEM|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/05/2014|11/06/2014|||APPR|APPROVAL FOR THE LATITUDE CONSULT SYSTEM RELEASE 1.01 WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.
P100029|S017|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2014|09/30/2014|||OK30|ALTERNATE LASER CUTTING SYSTEM FOR MANUFACTURING TRIFECTA VALVE COMPONENTS.
P920015|S141|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VAISALA CONTINUOUS MONITORING SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/05/2014|10/02/2014|||OK30|IMPLEMENTATION OF A CONTINUOUS MONITORING SYSTEM AT THE SULLIVAN LAKE MANUFACTURING FACILITY.
P840001|S283|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/03/2014|||OK30|ADD A STERILIZATION SYSTEM AT THE SULLIVAN LAKE FACILITY.
P970004|S184|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/03/2014|||OK30|ADD A STERILIZATION SYSTEM AT THE SULLIVAN LAKE FACILITY.
P960009|S206|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/03/2014|||OK30|ADD A STERILIZATION SYSTEM AT THE SULLIVAN LAKE FACILITY.
P860004|S213|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/03/2014|||OK30|ADD A STERILIZATION SYSTEM AT THE SULLIVAN LAKE FACILITY.
P080025|S080|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2014|10/03/2014|||OK30|ADD A STERILIZATION SYSTEM AT THE SULLIVAN LAKE FACILITY.
P830055|S149|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2014|10/08/2014|||OK30|INTRODUCTION OF NEW TESTING EQUIPMENT
P010032|S084|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|TRIPOLE 16 & 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44 & LAMITRODE 44C LEADS, LAMITRODE 88 LEAD, LAMITRODE S-4|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2014|10/06/2014|||OK30|ADD MANUFACTURING PROCESS CHANGES TO THE CUTTINGMETHODS, AND CHANGE IN THE FREQUENCY OF LUBRICANT DISPENSING.
P890023|S022|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/2014|11/21/2014|||APPR|APPROVAL FOR THE ADDITION OF THE NEW PRIVATE LABEL BRAND NAME EQUATE ASPHERE AND EQUATE TORIC TO THE DEVICE LABELING.
P830055|S150|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/2014|12/08/2014|||APPR|APPROVAL FOR THE ADDITION OF TRU-MATCH PIN GUIDES AS COMPATIBLE COMPONENTS WITH THE DEPUY LCS® TOTAL KNEE SYSTEM AND THE ADDITION OF MEDICAL MODELING INCORPORATED AS A MANUFACTURING SITE FOR THESE COMPONENTS.
P080006|S073|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN PERFORMA MODEL 4398 AND 4598 LEFT VENTRICULAR LEADS|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/09/2014|12/10/2014|||APPR|APPROVAL FOR THE ATTAIN PERFORMATM LEFT VENTRICULAR LEADS (MODELS 4398 AND 4598), INDICATED FOR CHRONIC PACING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM.
P030017|S204|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2014|10/09/2014|||OK30|ADD A SUPPLIER OF CABLES.
P060019|S029|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THE COOL POINT IRRIGATION PUMP|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/09/2014|11/06/2014|||APPR|APPROVAL TO IMPLEMENT A MINOR DESIGN MODIFICATION TO THE COOL POINT IRRIGATION PUMP TO INCLUDE A PUMP PRESSURE ALARM ADAPTER AND A PRESSURE ALARM ADAPTER CABLE.
P980035|S394|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2014|09/25/2014|||OK30|UPDATES TO THE TEMPERATURE EXPOSURE REQUIREMENTS ON DEVICE ASSEMBLY DRAWINGS.
P010015|S250|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2014|09/25/2014|||OK30|UPDATES TO THE TEMPERATURE EXPOSURE REQUIREMENTS ON DEVICE ASSEMBLY DRAWINGS.
P030017|S205|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2014|10/09/2014|||OK30|ADD A SUPPLIER OF PRINTED CIRCUIT BOARD COMPONENTS.
P040004|S010|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2014|02/27/2015|||APPR|APPROVAL FOR CLAIMS TO TEST NEONATE AND PEDIATRIC POPULATIONS WITH THE FDA APPROVED ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS AND IS INDICATED FOR:ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMSTHE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE CORE ANTIGEN OF THE HEPATITIS B VIRUS (HBC TOTAL) IN HUMAN NEONATAL, PEDIATRIC AND ADULT SERUM OR PLASMA (POTASSIUM EDTA, OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND IN THE DETERMINATION OF THE CLINICAL STATUS OF HBV INFECTED INDIVIDUALS IN CONJUNCTION WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. THIS ASSAY CAN ALSO BE USED AS AN AID IN THE DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.ADVIA CENTAUR CP SYSTEM:THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE CORE ANTIGEN OF THE HEPATITIS B VIRUS (HBC TOTAL) IN HUMAN NEONATAL, PEDIATRIC, AND ADULT SERUM OR PLASMA (POTASSIUM EDTA, OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND IN THE DETERMINATION OF THE CLINICAL STATUS OF HBV INFECTED INDIVIDUALS IN CONJUNCTION WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.  FOR ADDITIONAL INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
P130004|S005|OCULAR THERAPEUTICS, INC.|36 CROSBY DR SUITE 101||BEDFORD|MA|01730||Ophthalmic Sealant|RESURE SEALANT|PFZ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2014|10/10/2014|||OK30|CRITICAL SUPPLIER LOCATION CHANGE- ADDITIONAL FACILITY FOR JENKEM.
P990065|S007|SIRTEX MEDICAL LIMITED|UNIT F6 PARKVIEW 16 MARS ROAD||LANE COVE||NSW 2||Microspheres radionuclide|SIR-SPHERE MICROSPHERES|NAW|RA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2014|10/09/2014|||APPR|APPROVAL FOR AN OPTIONAL USE OF AN ALTERNATE NON-IONIC SOLUTION 5% DEXTROSE (D5W).
P060010|S012|SRS MEDICAL|76 TREBLE COVE ROAD, #3||NORTH BILLERICA|MA|01862||Stent, urethral, prostatic, semi-permanent|THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES|NZC|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2014|10/06/2014|||OK30|UTILIZATION OF A LARGER EXISTING CLEANROOM WITHIN THE CURRENT MANUFACTURING FACILITY.
P130021|S007|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE (R) SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2014|10/10/2014|||OK30|EXPAND THE CAPACITY OF THE CLEAN ROOM USED TO PERFORM THE TISSUE PROCESSING STEPS FOR THE COREVALVE TRANSCATHETER AORTIC VALVE AT THE MEDTRONIC MEXICO FACILITY.
P830055|S151|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2014|10/10/2014|||OK30|IMPLEMENT ADDITIONAL DEVICE IDENTIFICATION MEASURES.
P000029|S079|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2014|10/10/2014|||OK30|CHANGE THE ENVIRONMENTAL LIMITS OF THE CLEAN ROOMS AT THE FIRM.
P100014|S016|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA INJECTABLE GEL|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2014|10/10/2014|||OK30|CHANGES TO THE ENVIRONMENTAL LIMITS OF THE CLEAN ROOMS USED DURING SOLESTA MANUFACTURING.
P990071|S029|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|COOLFLOW IRRIGATION PUMP|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/10/2014|11/19/2014|||APPR|APPROVAL FOR CHANGES TO SOLDER COMPOSITION REQUIRED FOR EU ROHS COMPLIANCE.
P130017|S001|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/10/2014|02/02/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010013|S060|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2014|10/06/2014|||OK30|UPDATE ON MANUFACTURING PROCEDURE TO REDUCE SCRAP AT THE WORK STATION.
P950029|S096|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/09/2014|01/06/2015|||APPR|APPROVAL FOR DESIGN CHANGES TO AND AN ALTERNATE SUPPLIER FOR THE G-SENSOR COMPONENT USED IN THE ACCELEROMETER OF THE REPLY AND ESPRIT PACEMAKERS.
P030022|S031|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|R3 ACETABULAR SHELLS|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2014|10/17/2014|||OK30|NEW VENDORS.
P050007|S032|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2014|10/10/2014|||OK30|MODIFIED CLEANING PROCESS FOR THE CLIP SUBASSEMBLY.
P120005|S028|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/12/2014|01/23/2015|||APPR|FOR THE ADDITION OF A BLUETOOTH LOW ENERGY (BLE) RADIO TO BOTH THEADULT (MT20649) AND PEDIATRIC (MT22430) VERSIONS OF THE DEXCOM G4 PLATINUM RECEIVER,IDENTIFIED AS THE DEXCOM G4 PLATINUM RECEIVER WITH SHARE (ADULT - MT22495, PEDIATRIC -MT22608), AND FOR A MODIFICATION TO THE DEXCOM SHARE SYSTEM (STA-GL-400) ALLOWING THEDEXCOM G4 PLATINUM RECEIVER WITH SHARE TO COMMUNICATE DIRECTLY WITH THE DEXCOM SHARE2MOBILE APPLICATION INSTALLED ON A USER¿S APPLE MOBILE DEVICE. THE DEXCOM RECEIVER WITH SHAREIS A COMPONENT OF THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, THEDEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE DEXCOMSHARE SYSTEM. THOUGH THE INDICATIONS FOR USE FOR THE DEXCOM G4 PLATINUM CONTINUOUSGLUCOSE MONITORING SYSTEM AND THE DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSEMONITORING SYSTEM ARE UNCHANGED BY THIS SUPPLEMENT, THE DEXCOM SHARE SYSTEM, AS MODIFIED,WILL BE MARKETED UNDER THE TRADE NAME DEXCOM SHARE SYSTEM AND IS INDICATED FOR:THE PURPOSE OF DEXCOM SHARE IS TO NOTIFY ANOTHER PERSON, THE FOLLOWER, OF THE PATIENT¿SDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM SENSOR GLUCOSEINFORMATION. DEXCOM SHARE PROVIDES SECONDARY NOTIFICATION AND DOES NOT REPLACE REAL TIMECONTINUOUS GLUCOSE MONITORING (G4 PLATINUM SYSTEM) OR STANDARD HOME BLOOD GLUCOSEMONITORING.
P110013|S045|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2014|10/08/2014|||OK30|MODIFICATION TO THE RESIDUAL SOLVENTS QUALITY CONTROL TEST METHOD.
P840062|S042|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORABABLE COLLAGEN WOUND GRESSING FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/16/2014|||OK30|USE OF A NEW QUALITY CONTROL TEST METHOD.
P810006|S055|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/16/2014|||OK30|USE OF A NEW QUALITY CONTROL TEST METHOD.
P850010|S055|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/16/2014|||OK30|USE OF A NEW QUALITY CONTROL TEST METHOD.
P000037|S038|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/10/2014|||OK30|CHANGE TO THE SOFTWARE USED FOR THE PROOFTESTER EQUIPMENT.
P900033|S038|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/16/2014|||OK30|USE OF A NEW QUALITY CONTROL TEST METHOD.
P020045|S063|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES,|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/15/2014|||OK30|CHANGES TO PACKAGING/LABELING SYSTEMS USED TO TRIGGER LABEL PRINTING AND FACILITATE SELECTION OF PRODUCT DETERMINATION FOR PACKAGING.
P930039|S119|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/14/2014|||OK30|OUTSOURCE THE SUPPLY OF THREE MOLDED COMPONENTS USED IN THE MANUFACTURE OF THE LEAD MODELS.
P100010|S045|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETERS, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARDIAC|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/15/2014|||OK30|CHANGES TO PACKAGING/LABELING SYSTEMS USED TO TRIGGER LABEL PRINTING AND FACILITATE SELECTION OF PRODUCT DETERMINATION FOR PACKAGING.
P090013|S157|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD.|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/14/2014|||OK30|OUTSOURCE THE SUPPLY OF THREE MOLDED COMPONENTS USED IN THE MANUFACTURE OF THE LEAD MODELS.
P980016|S504|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/03/2014|||OK30|REDUCTION IN THE FREQUENCY OF WELD MONITORING.
P920015|S142|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TUNNELIING TOOL|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/07/2014|||OK30|ADDITION OF NEW ETHYLENE OXIDE (EO) STERILIZER SYSTEM FOR THE DEVICE.
P030031|S061|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMO-COOL SF (BI-DIRECTIONAL AND UNI-DIRECTIONAL ) CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/15/2014|||OK30|MODIFICATION OF THE PROCESS USED TO MANUFACTURE THE THERMOCOOL SF IRRIGATED TIP SHELL.
P960058|S111|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2014|09/02/2015|||APPR|APPROVAL FOR A NEW HYBRID PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) FOR THE HIRES 90K FAMILY OF COCHLEAR IMPLANTS.
P920015|S143|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/14/2014|||OK30|OUTSOURCE THE SUPPLY OF THREE MOLDED COMPONENTS USED IN THE MANUFACTURE OF THE LEAD MODELS.
P980049|S102|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pacemaker/icd/crt non-implanted components|PARADYM RF VR 9250 PARADYM RF DR 9550|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2014|11/06/2014|||APPR|APPROVAL FOR A CHANGE TO THE SOFTWARE CODE FOR THE SMARTVIEW(HOME) MONITOR USED FOR THE DEVICES.
P060027|S069|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF CRT-D9750|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2014|11/06/2014|||APPR|APPROVAL FOR A CHANGE TO THE SOFTWARE CODE FOR THE SMARTVIEW(HOME) MONITOR USED FOR THE DEVICES.
P110038|S006|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|09/30/2014|||OK30|ALTERNATE COLORANT IN THE DELIVERY SYSTEM TIP.
P990074|S031|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2014|03/13/2015|||APPR|APPROVAL FOR THE FOLLOWING PACKAGING AND MANUFACTURING CHANGES:1) MODIFICATION OF THE PRIMARY INNER AND OUTER TRAY PACKAGING TO INCLUDE TWO FINGER TABS;2) MODIFICATION OF THE OUTER TRAY TO INCLUDE TWO CAVITIES;3) A CHANGE OF THE POLYCARBONATE TRAY MATERIAL TO GEOX PEEREX® 51 PC POLYCARBONATE FILM TO BE SUPPLIED BY PRENT THERMOFORMING;4) PRIMARY LID PACKAGING THAT IS LARGER WITH BLUE INK ARROWS; 5) LARGER SECONDARY PACKAGING BOXES TO HOUSE THE LARGER TRAYS;6) A CHANGE TO A SEPARATE TAMPER EVIDENT LABEL, I.E., THE PRODUCT LABELS NO LONGER SERVE AS A TAMPER EVIDENT LABEL; AND7) CHANGES TO THE HEAT SEALING PROCESS (NEW PARAMETERS: TEMPERATURE = 236-256OF, DWELL TIME = 4.9-6.9 S, PRESSURE = 60-80 PSI).
P010031|S468|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/03/2014|||OK30|REDUCTION IN THE FREQUENCY OF WELD MONITORING.
P030056|S008|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR HCV READYPACKS|MZO|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/2014|03/10/2015|||APPR|APPROVAL FOR THE CLAIM TO TEST A PEDIATRIC POPULATION WITH THE FDA APPROVED ADVIA CENTAUR HCV READYPACK REAGENTS AND ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HCV READYPACK REAGENTS AND ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS AND IS INDICATED FOR:ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS.  THE ADVIA CENTAUR HCV (AHCV) ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN PEDIATRIC (18 MONTHS ¿ 21 YEARS) AND ADULT SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THE DIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS C INFECTION.ADVIA CENTAUR CP SYSTEM:  THE ADVIA CENTAUR HCV (AHCV) ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN PEDIATRIC (18 MONTHS ¿ 21 YEARS) AND ADULT SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THE DIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS C INFECTION.
P980006|S023|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION (BALAFILCON A) VISABILITY TINTED CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2014|10/15/2014|||OK30|ADDITIONAL VENDOR FOR A RAW MATERIAL (MONOMER) IN THE PUREVISION® (BALAFILCON A) PRODUCT FAMILY.
P020056|S027|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2014|03/13/2015|||APPR|APPROVAL FOR THE FOLLOWING PACKAGING AND MANUFACTURING CHANGES:1) MODIFICATION OF THE PRIMARY INNER AND OUTER TRAY PACKAGING TO INCLUDE TWO FINGER TABS;2) MODIFICATION OF THE OUTER TRAY TO INCLUDE TWO CAVITIES;3) A CHANGE OF THE POLYCARBONATE TRAY MATERIAL TO GEOX PEEREX® 51 PC POLYCARBONATE FILM TO BE SUPPLIED BY PRENT THERMOFORMING;4) PRIMARY LID PACKAGING THAT IS LARGER WITH BLUE INK ARROWS; 5) LARGER SECONDARY PACKAGING BOXES TO HOUSE THE LARGER TRAYS;6) A CHANGE TO A SEPARATE TAMPER EVIDENT LABEL, I.E., THE PRODUCT LABELS NO LONGER SERVE AS A TAMPER EVIDENT LABEL; AND7) CHANGES TO THE HEAT SEALING PROCESS (NEW PARAMETERS: TEMPERATURE = 236-256OF, DWELL TIME = 4.9-6.9 S, PRESSURE = 60-80 PSI).
P040046|S009|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2014|03/13/2015|||APPR|APPROVAL FOR THE FOLLOWING PACKAGING AND MANUFACTURING CHANGES:1) MODIFICATION OF THE PRIMARY INNER AND OUTER TRAY PACKAGING TO INCLUDE TWO FINGER TABS;2) MODIFICATION OF THE OUTER TRAY TO INCLUDE TWO CAVITIES;3) A CHANGE OF THE POLYCARBONATE TRAY MATERIAL TO GEOX PEEREX® 51 PC POLYCARBONATE FILM TO BE SUPPLIED BY PRENT THERMOFORMING;4) PRIMARY LID PACKAGING THAT IS LARGER WITH BLUE INK ARROWS; 5) LARGER SECONDARY PACKAGING BOXES TO HOUSE THE LARGER TRAYS;6) A CHANGE TO A SEPARATE TAMPER EVIDENT LABEL, I.E., THE PRODUCT LABELS NO LONGER SERVE AS A TAMPER EVIDENT LABEL; AND7) CHANGES TO THE HEAT SEALING PROCESS (NEW PARAMETERS: TEMPERATURE = 236-256 DEGREE F, DWELL TIME = 4.9-6.9 S, PRESSURE = 60-80 PSI).
P910023|S344|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2014|10/10/2014|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE IS-1 LEAD BORES FOR THE DEVICES.
P880086|S247|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY/ENDURITY FAMILIES OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2014|10/10/2014|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE IS-1 LEAD BORES FORTHE DEVICES.
P030035|S125|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ALLURE FAMILY OF CRT-P'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2014|10/10/2014|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE IS-1 LEAD BORES FORTHE DEVICES.
P080012|S023|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2014|07/29/2015|||APPR|APPROVAL FOR THE PATIENT THERAPY CONTROLLER AND CONFIGURATION DEVICE FOR USE WITH THE PROMETRA PROGRAMMABLE INFUSION SYSTEM.
P840001|S284|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEM, PISCES, SPECIFY AND VECTRIS, SPINAL CORD STIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|10/16/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MANUFACTURING FACILITIES.
P080025|S081|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|10/16/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MANUFACTURING FACILITIES.
P860004|S214|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEN|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|10/16/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MANUFACTURING FACILITIES.
P840001|S285|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE SCS NEUROSTIMULATORS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|10/16/2014|||OK30|SEVERAL CHANGES TO THE INSPECTION METHODS FOR THE BATTERY AND BATTERY SUBCOMPONENTS.
P960009|S207|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA FAMILY OF IMPLANTABLE DEEP BRAIN IMPLANTABLE NEUROSTIMULATORS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|10/16/2014|||OK30|SEVERAL CHANGES TO THE INSPECTION METHODS FOR THE BATTERY AND BATTERY SUBCOMPONENTS.
P070026|S023|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX (R) CERAMIC TOTAL HIP SYSTEM|MRA|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|01/30/2015|||APPR|APPROVAL FOR THE RELOCATION OF MANUFACTURING PROCESSES.
P990034|S033|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ISOMED PUMP AND INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|10/16/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MANUFACTURING FACILITIES.
P960009|S208|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|10/16/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MANUFACTURING FACILITIES.
P970004|S185|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2014|10/16/2014|||OK30|UPDATE THE SOFTWARE USED AT SEVERAL MANUFACTURING FACILITIES.
P990040|S019|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2014|11/05/2014|||APPR|APPROVAL TO REPLACE THE CURRENT STERILE POUCH FOR THE TRUFILL®N-BCA AND THE TANTALUM POWDER COMPONENTS WITH A NEW STERILE POUCH OF THE SAME MATERIALS AS THE EXISTING POUCH WITH A NEW POUCH COATING AND NEW THUMB NOTCHES AND IS SOURCED FROM A NEW VENDOR, OLIVER-TOLAS HEALTHCARE PRODUCTS.
P100047|S050|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2014|10/10/2014|||OK30|CHANGES TO THE PROCESS CHALLENGE DEVICE (PCD) USED FOR MONITORING THE ETHYLENE OXIDE STERILIZATION CYCLE OF THE STERILIZED COMPONENTS.
P080006|S074|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN PERFORMA MODEL 4298 LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2014|10/02/2014|||OK30|UPDATING THE FINAL PACKAGING LINE AT THE VILLALBA, PUERTO RICO FACILITY.
P010012|S372|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4 ORIGEN,ORIGEN X4, INCEPTA, ENERGEN, PUNCTUA CRT-DS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2014|10/16/2014|||OK30|VERTICALLY INTEGRATE THE MANUFACTURE OF THE SPRING CONTACTS USED IN THE HEADER COMPONENTS OF THE DEVICES.
P960040|S333|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN EL,ORIGEN MINI, INOGEN EL,INOGEN MINI, DYNAGEN EL,DYNAGEN MINI, INCEPTA, ENERGEN, PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2014|10/16/2014|||OK30|VERTICALLY INTEGRATE THE MANUFACTURE OF THE SPRING CONTACTS USED IN THE HEADER COMPONENTS OF THE DEVICES.
P960009|S209|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2014|10/17/2014|||OK30|CHANGES TO THE LEAD CAP INSPECTION PROCESS.
P120022|S001|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCEEN EGFR RGQ PCR KIT|OWD|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/18/2014|07/10/2015|||APPR|APPROVAL FOR EXTENDING THE LABEL CLAIM OF THE THERASCREEN® EGFR RGQ PCR KIT TO INCLUDE AN INDICATION FOR IRESSA (GEFITINIB). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERASCREEN® EGFR RGQ PCR KIT AND IS INDICATED FOR:THE THERASCREEN® EGFR RGQ PCR KIT IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED TO SELECT PATIENTS WITH NSCLC FOR WHOM GILOTRIF (AFATINIB) OR IRESSA (GEFITINIB), EGFR TYROSINE KINASE INHIBITORS (TKIS), IS INDICATED. SAFETY AND EFFICACY OF GILOTRIF (AFATINIB) AND IRESSA (GEFITINIB) HAVE NOT BEEN ESTABLISHED IN THE PATIENTS WHOSE TUMORS HAVE L861Q, G719X, S768I, EXON 20 INSERTIONS, AND T790M MUTATIONS, WHICH ARE ALSO DETECTED BY THE THERASCREEN EGFR RGQ PCR KIT.SPECIMENS ARE PROCESSED USING THE QIAAMP DSP DNA FFPE TISSUE KIT FOR MANUAL SAMPLE PREPARATION AND THE ROTOR-GENE Q MDX INSTRUMENT FOR AUTOMATED AMPLIFICATION AND DETECTION.
P860004|S215|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/17/2014|||OK30|MANUFACTURING CHANGES TO THE ANCHOR DISPENSER TOOL (ADT) USED DURING THE MANUFACTURING PROCESS.
P950037|S140|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SELOX ST, SELOX JT, SETROX S, DEXTRUS, TILDA, SOLOX SLX, SAFIO|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/10/2014|||OK30|USE OF SUPPLEMENTAL STERILIZATION EQUIPMENT.
P980023|S061|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART SD, LINOX SMART TD, LINOX SMART S, LINOX SMART T, LINOX SMART S DX, VIGILA 1CR, VOLTA 1CR, KAINOX VCS,PROTEG|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/10/2014|||OK30|USE OF SUPPLEMENTAL STERILIZATION EQUIPMENT.
P070008|S055|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW, COROX OTW-L, CELERITY|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/10/2014|||OK30|USE OF SUPPLEMENTAL STERILIZATION EQUIPMENT.
P020009|S126|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|CHANGE TO THE CARRIER TUBE MANUFACTURING PROCESS.
P040016|S132|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|CHANGE TO THE CARRIER TUBE MANUFACTURING PROCESS.
P050042|S030|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV (LN IL79)|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A MATERIAL USED IN THE MANUFACTURE OF UPSTREAM ASSAY COMPONENTS.
P080023|S025|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE (LN 6L22)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A MATERIAL USED IN THE MANUFACTURE OF UPSTREAM ASSAY COMPONENTS.
P060035|S023|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M (LN 6L23)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A MATERIAL USED IN THE MANUFACTURE OF UPSTREAM ASSAY COMPONENTS.
P020004|S104|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|IMPLEMENTING A SURFACE TREATMENT PROCESS FOR THE PACKAGING MANDRELS USED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS.
P010015|S251|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|UPDATES TO THE DISTRIBUTION CENTER SORTER TOOL SYSTEM.
P010031|S469|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|UPDATES TO THE DISTRIBUTION CENTER SORTER TOOL SYSTEM.
P090013|S158|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|UPDATES TO THE DISTRIBUTION CENTER SORTER TOOL SYSTEM.
P980016|S505|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA I|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|UPDATES TO THE DISTRIBUTION CENTER SORTER TOOL SYSTEM.
P980035|S395|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/16/2014|||OK30|UPDATES TO THE DISTRIBUTION CENTER SORTER TOOL SYSTEM.
P020004|S105|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/17/2014|||OK30|IMPLEMENTATION OF A NEW COATING ON A MANUFACTURING AID MANDREL.
P000040|S033|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/21/2014|||OK30|REMOVE REDUNDANT INSPECTIONS.
P040043|S068|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/17/2014|||OK30|IMPLEMENTATION OF A NEW COATING ON A MANUFACTURING AID MANDREL.
P850068|S012|Bausch & Lomb, Inc.|14853 DEVEAU PLACE||MINNETONKA|MN|55345||Lenses, soft contact, extended wear|SILSOFT (CLASTOFILCON A) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/17/2014|||OK30|ADDITIONAL AUTOCLAVE FOR THE SILSOFT® (ELASTOFILCON A) CONTACT LENSES.
P040037|S071|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/17/2014|||OK30|IMPLEMENTATION OF A NEW COATING ON A MANUFACTURING AID MANDREL.
P130006|S011|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2014|10/17/2014|||OK30|IMPLEMENTATION OF A NEW COATING ON A MANUFACTURING AID MANDREL.
P840062|S043|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE,COLLAPLUG ABSORBABLE COLLAGEN WOUND GRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/22/2014|||OK30|USE OF AN UPDATED QUALITY CONTROL TEST METHOD.
P810006|S056|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/22/2014|||OK30|USE OF AN UPDATED QUALITY CONTROL TEST METHOD.
P850010|S056|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/22/2014|||OK30|USE OF AN UPDATED QUALITY CONTROL TEST METHOD.
P900033|S039|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/22/2014|||OK30|USE OF AN UPDATED QUALITY CONTROL TEST METHOD.
P920047|S074|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD, BLAZER PRIME HTD|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/21/2014|||OK30|CHANGE TO THE WELDING EQUIPMENT FOR THE HANDLE ASSEMBLY OF THE BLAZER FAMILY OF CATHETERS.
P020025|S064|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/21/2014|||OK30|CHANGE TO THE WELDING EQUIPMENT FOR THE HANDLE ASSEMBLY OF THE BLAZER FAMILY OF CATHETERS.
P020018|S053|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH (FLEX) AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/21/2014|||OK30|ALTERNATE METHOD TO SEAL THE STENT GRAFT FABRIC EDGES.
P060038|S021|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART CALVE WITH PHOSPHOLIPID REDUCTION TREATMENT|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/22/2014|11/25/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100041|S059|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN TRANSCATHETER HEART VALVE (THV)|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/20/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX.
P950005|S053|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/21/2014|||OK30|ADDITION OF A QUALIFIED SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESSES OF THE CATHETER IN THE DEVICES.
P990025|S041|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/21/2014|||OK30|ADDITION OF A QUALIFIED SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESSES OF THE CATHETER IN THE DEVICES.
P010068|S042|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVI-STAR RMT DS ELECTROPHYSIOLOGY CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/21/2014|||OK30|ADDITION OF A QUALIFIED SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESSES OF THE CATHETER IN THE DEVICES.
P130030|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PTCR CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/21/2014|||OK30|ELIMINATE BURST, DIAMETER, AND DISTENSION IN-PROCESS MONITORING REQUIREMENTS FROM THE BALLOON COMPONENT MANUFACTURING PROCESS.
P110021|S045|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN TRANSCATHETER HEART VALVE (THV)|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/20/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX.
P980022|S161|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/2014|02/13/2015|||APPR|APPROVAL FOR CHANGES TO THE PUMP MOTOR SINTERED BEARING MATERIAL.
P120010|S036|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|09/22/2014|02/13/2015|||APPR|APPROVAL FOR CHANGES TO THE PUMP MOTOR SINTERED BEARING MATERIAL.
P020036|S030|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|CORDIS SMART/ SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2014|10/23/2014|||OK30|CHANGES TO OPTIMIZE THE POUCH SEALING PROCESS AS WELL AS A NEW POUCH SEALER.
P120002|S005|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|CORDIS SMART/SMART CONTROL VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2014|10/23/2014|||OK30|CHANGES TO OPTIMIZE THE POUCH SEALING PROCESS AS WELL AS A NEW POUCH SEALER.
P030047|S027|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2014|10/23/2014|||OK30|CHANGES TO OPTIMIZE THE POUCH SEALING PROCESS AS WELL AS A NEW POUCH SEALER.
P130009|S012|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2014|10/20/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX.
P110013|S046|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/23/2014|12/18/2014|||APPR|APPROVAL FOR A CHANGE IN THE SHELF LIFE FOR THE RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM FROM 18 MONTHS TO 24 MONTHS.
P060028|S002|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2014|10/29/2014|||OK30|CHANGE TO CONVERT THE MANUAL BARCODE MANUFACTURING PROCESS TO AN AUTOMATED PROCESS TO THE MANDREL USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P030053|S020|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2014|10/29/2014|||OK30|CHANGE TO CONVERT THE MANUAL BARCODE MANUFACTURING PROCESS TO AN AUTOMATED PROCESS TO THE MANDREL USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P990075|S027|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2014|10/29/2014|||OK30|CHANGE TO CONVERT THE MANUAL BARCODE MANUFACTURING PROCESS TO AN AUTOMATED PROCESS TO THE MANDREL USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P890064|S031|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HC2 SYSTEM SOFTWARE|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|09/23/2014|10/09/2014|||APPR|APPROVAL FOR THE UPGRADE OF THE HC2 SOFTWARE SUITE TO VERSION 4.3.
P130016|S009|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/24/2014|04/08/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: 1) ADDITION OF THE IMPLANT EAR, ELECTRIC ONLY TEST CONDITION, AND 2) MODIFICATION OF THE TESTING SCHEDULE TO INCLUDE A TIERED APPROACH.
P110014|S004|DUNE MEDICAL DEVICES INC|111 SPEEN ST SUITE 101||FRAMINGHAM|MA|01701||Diagnostic low electric field|MARGINPROBE SYSTEM|OEE|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2014|10/22/2014|||OK30|ADDITION OF A TEST JIG AND THE REPLACEMENT OF THE VACUUM PRESSURE REGULATOR COMPONENT.
P980040|S050|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|10/23/2014|||OK30|ADD A NEW OIL-FREE COMPRESSED AIR (OFCA) SYSTEM AT THE AMO ANASCO, PUERTO RICO FACILITY.
P950037|S141|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ENTOVIS, EVIA, ESTELLA, EFFECTA, ECURO, DEXTRUS, SETROX, SELOX, TILDA, P-KIT, SAFIO, SLX, CARDIOMESSENGER LLT KIT, ICS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|10/21/2014|||OK30|CHANGE TO THE LABELING SOFTWARE WHICH IS USED TO PRINT LABELS FOR THE DEVICES.
P070008|S056|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|EVIA HF-T, ENTOVIS HF-T, STRATOS LV, COROX OTW, CELERITY 2D,LV-KIT|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|10/21/2014|||OK30|CHANGE TO THE LABELING SOFTWARE WHICH IS USED TO PRINT LABELS FOR THE DEVICES.
P980023|S062|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART SD, VIGILA 1CR, VOLTA 1CR,  LINOX SMART S DX, PROTEGO SD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|10/21/2014|||OK30|CHANGE TO THE LABELING SOFTWARE WHICH IS USED TO PRINT LABELS FOR THE DEVICES.
P000009|S059|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ICS 3000/ RENAMIC PROGRAMMERS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|10/21/2014|||OK30|CHANGE TO THE LABELING SOFTWARE WHICH IS USED TO PRINT LABELS FOR THE DEVICES.
P050023|S080|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LLESTO 7 VR-T, IFORIA 7 VR-T, LLESTO 5 VR-T, IFORIA 5 VR-T, LUMAX 740 VR-T, LLESTO 7 DR-T, IFORIA 7 DR-T, LLESTO 5 DR-T|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|10/21/2014|||OK30|CHANGE TO THE LABELING SOFTWARE WHICH IS USED TO PRINT LABELS FOR THE DEVICES.
P040037|S072|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|10/24/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE PTFE RESIN RAW MATERIAL.
P130006|S012|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|10/24/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE PTFE RESIN RAW MATERIAL.
P100034|S011|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVA TTF-100A SYSTEM|NZK|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|03/17/2015|||APPR|APPROVAL FOR AN ADDITIONAL MATERIAL SUPPLIER.
P100034|S012|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOTTF-100A SYSTEM|NZK|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2014|03/23/2015|||APPR|APPROVAL FOR AN ADDITIONAL SUPPLIER FOR THE CONVERTER.
P070015|S125|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EECSS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2014|10/22/2014|||OK30|CHANGE TO THE TIMING OF SAMPLING FOR PARTICULATE TESTING FOR PRODUCT RELEASE TESTING.
P110019|S072|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; LL,; SV; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTE|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2014|10/22/2014|||OK30|CHANGE TO THE TIMING OF SAMPLING FOR PARTICULATE TESTING FOR PRODUCT RELEASE TESTING.
P010031|S470|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D, EVERA S DR ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2014|10/17/2014|||OK30|NEW PRESS CRIMP EQUIPMENT AND PROCESS FOR THE  DEVICES.
P980016|S506|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2014|10/17/2014|||OK30|NEW PRESS CRIMP EQUIPMENT AND PROCESS FOR THE  DEVICES.
P950037|S142|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ENTOVIS DR-T,DR,SR-T,SR; ELUNA 8 DR-T PROMRI,DR PROMRI,SR-T PRMRI,SR PROMRI;SETROX S53,S60;SAFIO S53,S60|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2014|03/19/2015|||APPR|APPROVAL FOR THE REMOVAL OF THE SCAN LOCATION RESTRICTIONS FOR THE PROMRIPACEMAKER SYSTEM AS WELL AS UPDATES TO THE ICS 3000/ RENAMIC PROGRAMMER SOFTWARE (1403.U) FOR THE DEVICES.
P000009|S060|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2014|03/19/2015|||APPR|APPROVAL FOR THE REMOVAL OF THE SCAN LOCATION RESTRICTIONS FOR THE PROMRIPACEMAKER SYSTEM AS WELL AS UPDATES TO THE ICS 3000/ RENAMIC PROGRAMMER SOFTWARE (1403.U) FOR THE DEVICES.
P050023|S081|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2014|03/19/2015|||APPR|APPROVAL FOR THE REMOVAL OF THE SCAN LOCATION RESTRICTIONS FOR THE PROMRIPACEMAKER SYSTEM AS WELL AS UPDATES TO THE ICS 3000/ RENAMIC PROGRAMMER SOFTWARE (1403.U) FOR THE DEVICES.
P070008|S057|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T, EVIA HF/HF-T, ENTOVIS HF/HF-T CRT-P'S|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/25/2014|03/19/2015|||APPR|APPROVAL FOR THE REMOVAL OF THE SCAN LOCATION RESTRICTIONS FOR THE PROMRIPACEMAKER SYSTEM AS WELL AS UPDATES TO THE ICS 3000/ RENAMIC PROGRAMMER SOFTWARE (1403.U) FOR THE DEVICES.
P930014|S075|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/21/2014|||OK30|MODIFIED/ SHORTENED CURING CYCLE FOR USE IN THE MANUFACTURING OF ACRYSOF® INTRAOCULAR LENSES.
P090013|S159|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/21/2014|||OK30|USE OF A NEW EQUIPMENT CONTROLLER FIXTURE TO COMMUNICATE THE LABEL TYPE AND LABEL CONTENT.
P830061|S116|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/21/2014|||OK30|USE OF A NEW EQUIPMENT CONTROLLER FIXTURE TO COMMUNICATE THE LABEL TYPE AND LABEL CONTENT.
P020047|S060|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK 8 CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/24/2014|||OK30|CHANGE TO THE PYROGEN TESTING PROCESS.
P930039|S120|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/21/2014|||OK30|USE OF A NEW EQUIPMENT CONTROLLER FIXTURE TO COMMUNICATE THE LABEL TYPE AND LABEL CONTENT.
P070015|S126|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/24/2014|||OK30|CHANGE TO THE PYROGEN TESTING PROCESS.
P110019|S073|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS), XIENCE XPEDITION EVEROLIMUS ELUTING|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/24/2014|||OK30|CHANGE TO THE PYROGEN TESTING PROCESS.
P100012|S006|NUVASIVE, INC.|7475 LUSK BLVD||SAN DIEGO|CA|92121||PROSTHESIS, INTERVERTEBRAL DISC|NU VASIVE PCM CERVICAL DISC SYSTEM|MJO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/26/2014|12/19/2014|||APPR|APPROVAL FOR A LOCKING PLATE DESIGN MODIFICATION, ADDITIONAL DEVICE SIZES AND MAGNETIC RESONANCE (MR) CONDITIONAL LABELING.
P910023|S345|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/21/2014|||OK30|ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE (HV) RF MODULES UTILIZED IN THE DEVICES ONLY.
P030054|S275|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUARDA, PROMOTE RF PROMOTE+ QUADRA ASSURA, UNIFY, ASSURA, UNIFY QUADRA FAMILI|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/21/2014|||OK30|ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE (HV) RF MODULES UTILIZED IN THE DEVICES ONLY.
P100023|S107|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/22/2014|||OK30|IMPLEMENT AN UPDATE TO SOFTWARE ON THE AUTOMATED CATHETER MANUFACTURING LINE.
P110010|S094|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PREMIER EVEROLIMUS-ELUTING CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/22/2014|||OK30|IMPLEMENT AN UPDATE TO SOFTWARE ON THE AUTOMATED CATHETER MANUFACTURING LINE.
P130030|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMINUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2014|10/22/2014|||OK30|IMPLEMENT AN UPDATE TO SOFTWARE ON THE AUTOMATED CATHETER MANUFACTURING LINE.
P840064|S057|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT,DUOVISC,DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|ALTERNATE CONTRACT ETHYLENE OXIDE STERILIZATION VENDOR FOR PROVISC®, VISCOAT®, DUOVISC®, AND DISCOVISC® OPHTHALMIC VISCOSURGICAL DEVICES.
P890047|S044|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|ALTERNATE CONTRACT ETHYLENE OXIDE STERILIZATION VENDOR FOR PROVISC®, VISCOAT®, DUOVISC®, AND DISCOVISC® OPHTHALMIC VISCOSURGICAL DEVICES.
P950005|S054|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2014|11/18/2014|||APPR|APPROVAL FOR CHANGES TO YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.
P110042|S041|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/23/2014|||OK30|MODIFICATION TO THE TEST SOFTWARE FOR THE S-ICD AT E2 AND E4 ELECTRICAL TEST STEPS.
P990025|S042|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR 4MM, NAVISTAR RMT 4MM, EZ STEER 4MM NAV|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2014|11/18/2014|||APPR|APPROVAL FOR CHANGES TO YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.
P900033|S040|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/28/2014|||OK30|QUALIFICATION OF A NEW SHIPPING CONTAINER FOR COLLAGEN PRODUCTS.
P010068|S043|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS, CELSIUS DS, EZ STEER NAV DS, NAVISTAR RMT DS, CELSIUS|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2014|11/18/2014|||APPR|APPROVAL FOR CHANGES TO YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.
P030031|S062|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL, CELSIUS THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL,CELSIUS RMT THERMOCOOL, THERMOCOOL|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2014|11/18/2014|||APPR|APPROVAL FOR CHANGES TO YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.
P040036|S046|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, THERMOCOOL ST|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2014|11/18/2014|||APPR|APPROVAL FOR CHANGES TO YOUR SOLDER IN ORDER TO COMPLY WITH THE EU ROHS DIRECTIVE.
P010032|S085|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PROTEGE MRI NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/29/2014|04/22/2015|||APPR|APPROVAL FOR THE PROTEGE MRI IPG MODEL 3 771 AND PATIENT PROGRAMMER (PPGR) MODEL 3853 WHICH HAVE UPDATED LABELING THAT WILL ALLOW PATIENTS TO UNDERGO MRI SCANS OF THE HEAD AND EXTREMITIES PER THE DEFINED CONDITIONS.
P120016|S006|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/23/2014|||OK30|REORGANIZATION OF TWO EXISTING MANUFACTURING STEPS AND A CHANGE OF LOCATION OF THE PROCESSES TO BE PERFORMED TO OUTSIDE OF A CONTROLLED ENVIRONMENT ROOM (CER).
P950022|S087|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA FAMILY OF HIGH VOLTAGE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/27/2014|||OK30|ADD AN ALTERNATE AIR STRINGING PROCESS FOR THE CABLES USED IN THE LEADS.
P990074|S032|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|CHANGE IN THE BIOBURDEN TESTING METHOD AND SAMPLES USED FOR TESTING.
P020056|S028|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|CHANGE IN THE BIOBURDEN TESTING METHOD AND SAMPLES USED FOR TESTING.
P040046|S011|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|CHANGE IN THE BIOBURDEN TESTING METHOD AND SAMPLES USED FOR TESTING.
P010015|S252|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD , ATTAIN OTW LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
P030036|S075|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECT SECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
P060039|S064|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
P090013|S160|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
P960040|S334|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN ICD, INOGEN ICD, ORIGEN ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/20/2014|||OK30|MANUFACTURE THE FEEDTHRU RIVETS OF THE HV CAPACITOR INTERNALLY FOR THE DEVICES RATHER THAN PURCHASING FROM A SUPPLIER.
P010012|S373|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/20/2014|||OK30|MANUFACTURE THE FEEDTHRU RIVETS OF THE HV CAPACITOR INTERNALLY FOR THE DEVICES RATHER THAN PURCHASING FROM A SUPPLIER.
P900033|S041|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|02/12/2015|||APPR|APPROVAL FOR CHANGES TO THE BIOBURDEN TESTING PROTOCOL FOR THE INTEGRA DERMAL REGENERATION TEMPLATE.
P020004|S106|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.
P050006|S043|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.
P980003|S054|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/28/2014|||OK30|CHANGE FOR A COMPONENT OF THE POLYURETHANE ADHESIVE USED FOR CHILLI II CATHETERS.
P040043|S069|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.
P040037|S073|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.
P130006|S013|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.
P040027|S038|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/29/2014|||OK30|IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.
P830061|S117|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
P850089|S112|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE Z NOVUS LEAD; VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
P890003|S322|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON BRILLIANT S+VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
P920015|S144|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
P930039|S121|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|10/21/2014|||OK30|TRANSFER INCOMING INSPECTIONS OF SPECIFIED COMPONENTS TO MEDTRONIC PUERTO RICO OPERATIONS CENTER AND FEDERAL EXPRESS CORPORATION/3PL.
N18286|S027|PFIZER, INC.|235 EAST 42ND ST.||NEW YORK|NY|10017||Agent, absorbable hemostatic, collagen based|GELFOAM PLUS HEMOSTATS KITS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2014|11/04/2014|||OK30|PROPOSED ADDITION OF AN ALTERNATE PRODUCTION AREA FOR GELFOAM BULK SOLUTION MANUFACTURING.
P060037|S032|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX AND LPS MOBILE BEARING KNEES|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2014|03/10/2015|||APPR|APPROVAL FOR A CHANGE IN WATER QUALITY MONITORING
P110010|S096|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2014|06/01/2015|15M-2077|06/30/2015|APPR|APPROVAL FOR THE PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUMCORONARY STENT SYSTEMS (MONORAIL AND OVER-THE-WIRE). THESE DEVICES ARE INDICATED FORIMPROVING LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATICHEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES>=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
P080020|S013|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2014|10/30/2014|||OK30|CONTINUATION OF SHARED MANUFACTURING EQUIPMENT FOR ADDITIONAL PURPOSES.
P100023|S108|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2014|10/30/2014|||OK30|ELIMINATION OF A REDUNDANT IN-PROCESS STENT MASS MEASUREMENT STEP AT THE GALWAY AND PLYMOUTH MANUFACTURING SITES.
P950039|S031|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSORS|MKQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2014|11/20/2014|||APPR|APPROVAL FOR REFORMULATION OF TUBING THAT DELIVERS AIR AND PROCESSING REAGENTS TO THE PATIENTS SAMPLE, A CHANGE TO THE PUMP USED ON THE THINPREP® 3000 (TP3000) AND MODIFICATION OF THE T-2000 HEAD LEVER ASSEMBLY TO REDUCE TOLERANCE STACK-UP.
P110010|S097|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2014|10/30/2014|||OK30|ELIMINATION OF A REDUNDANT IN-PROCESS STENT MASS MEASUREMENT STEP AT THE GALWAY AND PLYMOUTH MANUFACTURING SITES.
P130030|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2014|10/30/2014|||OK30|ELIMINATION OF A REDUNDANT IN-PROCESS STENT MASS MEASUREMENT STEP AT THE GALWAY AND PLYMOUTH MANUFACTURING SITES.
P960042|S050|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATH SLS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2014|10/30/2014|||OK30|CHANGE IN THE OPTICAL FIBER INCOMING SAMPLING PLAN.
P950029|S097|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPIRIT SR, ESPRIT DR|NVZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/01/2014|10/23/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE IMPLANT MANUALS IN ALIGNMENT WITH A PREVIOUS SAFETY COMMUNICATION.
P110032|S009|LOMBARD MEDICAL TECHNOLOGIES INC|15420 LAGUNA CANYON ROAD|SUITE 260|IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2014|10/28/2014|||OK30|USE OF A NEW CLEANROOM AT AN EXISTING MANUFACTURING SITE.
P020049|S004|LEMAITRE VASCULAR INC|63 SECOND AVENUE||BURLINGTON|MA|01803||TISSUE GRAFT OF 6MM AND GREATER|PROCOL VASCULAR BIOPROSTHESIS|LXA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2014|10/31/2014|||OK30|ALTERNATE SUPPLIER FOR BOVINE VEINS.
P950029|S098|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR|NVZ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2014|11/07/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS PETIT-RECHAIN IN VERVIERS, BELGIUM.
P110012|S009|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT|OWE|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/2014|07/02/2015|||APPR|APPROVAL FOR USE OF ABBOTT VP 2000 PROCESSOR AND A CORRESPONDING SET OFREAGENTS IN AN AUTOMATED SLIDE PROCESSING PROCEDURE.
P010015|S253|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2014|10/16/2014|||OK30|SOFTWARE UPDATE FOR THE UNIVERSAL BURN-IN TEST SYSTEM (UBITS).
P080030|S012|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/30/2014|12/16/2014|||APPR|APPROVAL FOR THE MODIFICATIONS TO THE MODEL GTS100I INSERTER AND STENT, WHICH COMPRISE THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM. THE MODIFICATIONS INCLUDE THEFOLLOWING:1) CHANGES TO THE INSERTER TO INCLUDE:A) A LARGER SLEEVE DIAMETER FOR INCREASED RIGIDITY OF THE SLIDE ASSEMBLY;B) AN INCREASE IN THE INTERNAL SPRING FORCE; C) A CHANGE TO THE GEOMETRY AND EXTENSION OF THE GRASPING TINES ON THE END OF THE SLOTTED TUBE; D) A RE-DESIGN OF THE RELEASE BUTTON ROCKER MECHANISM; AND E) COLOR CHANGES TO TWO OUTER INSERTER COMPONENTS (REAR HOUSING AND TRIGGER BUTTON).2) CHANGES TO THE STENT TO INCLUDE:A) AN INCREASE IN THE WALL THICKNESS OF THE SNORKEL BY TIGHTENING THE DIMENSIONAL TOLERANCE FROM A RANGE 0.155 TO 0.200 MM TO A RANGE OF 0.170 TO 0.200 MM; AND B) REMOVAL OF THE STENTING HEIGHT PARAMETER FROM THE FINISHED DEVICE DRAWINGS 10-0018 AND 10-0019 AS A CRITICAL DIMENSION.3) CHANGES TO THE STENT SYSTEM TO INCLUDE:A) A CHANGE FROM STERILIZATION FOLLOWING PRIMARY PACKAGING TO STERILIZATION FOLLOWING FINAL PACKAGING; AND B) ELIMINATION OF THE IN-PROCESS GRIP FORCE TESTING STEP.
P010031|S471|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2014|10/16/2014|||OK30|SOFTWARE UPDATE FOR THE UNIVERSAL BURN-IN TEST SYSTEM (UBITS).
P090013|S161|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2014|10/16/2014|||OK30|SOFTWARE UPDATE FOR THE UNIVERSAL BURN-IN TEST SYSTEM (UBITS).
P890003|S323|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2014|10/16/2014|||OK30|SOFTWARE UPDATE FOR THE UNIVERSAL BURN-IN TEST SYSTEM (UBITS).
P980016|S507|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2014|10/16/2014|||OK30|SOFTWARE UPDATE FOR THE UNIVERSAL BURN-IN TEST SYSTEM (UBITS).
P060027|S070|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM VR 8250, PARADYM DR 8550, PARADYM CRT-D 8750, PARADYM RF VR 9250, PARADYM RF DR 9550, PARADYM M RF CRT-D 9750|NIK|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2014|11/07/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS PETIT-RECHAIN IN VERVIERS, BELGIUM.
P980049|S103|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|INTENSIA VR 124, INTENSIA DR 154, INTENSIA CRT-D 174|MRM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2014|11/07/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS PETIT-RECHAIN IN VERVIERS, BELGIUM.
P970051|S123|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/2014|04/02/2015|||APPR|APPROVAL FOR NEW DIGITAL SOUND PROCESSOR FIRMWARE FEATURES AS PART OF THE COCHLEAR NUCLEUS IMPLANT SYSTEM. THESE FEATURES INCLUDE A WIND NOISE REDUCTION (WNR) ALGORITHM, A SIGNAL-TO-NOISE RATIO-BASED NOISE REDUCTION (SNR-NR) FUNCTION, AND AN AUTOMATIC ENVIRONMENTAL CLASSIFIER (SCAN) FUNCTION.
P980035|S396|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2014|10/16/2014|||OK30|SOFTWARE UPDATE FOR THE UNIVERSAL BURN-IN TEST SYSTEM (UBITS).
P830055|S152|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|TRUMATCH SOLUTIONS|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|10/03/2014|12/31/2014|||APPR|APPROVAL FOR THE ADDITION OF A SEGMENTATION SOFTWARE PACKAGE FOR USE IN THE DESIGN OF TRUMATCH® RESECTION GUIDES AND PIN GUIDES.
P960040|S335|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2014|10/28/2014|||OK30|CHANGE IN THE SUPPLIERS MANUFACTURING PROCESS FOR THE BACKFILL HOLE IN THE HIGH VOLTAGE CAPACITOR CANS (HV CAP).
P010012|S374|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2014|10/28/2014|||OK30|CHANGE IN THE SUPPLIERS MANUFACTURING PROCESS FOR THE BACKFILL HOLE IN THE HIGH VOLTAGE CAPACITOR CANS (HV CAP).
P970053|S015|NIDEK CO., LTD.|34-14 MAEHAMA, HIROISHI-CHO||GAMAGORI, AICHI||443-0|0038|Excimer laser system|NIDEK EXCLAIMER LASER SYSTEM EC-5000|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/03/2014|03/30/2015|||APPR|APPROVAL FOR THE A NEW 1 KHZ EYETRACKER, WHICH REPLACES THE ORIGINAL 200 HZ EYETRACKER USED WITH THE EC-5000 EXCIMER LASER. THIS CHANGE ALSO INCLUDES MODIFICATION TO THE ASSOCIATED CAMERA AND SOFTWARE AS WELL AS THE INFRARED RED (IR) ILLUMINATION. THIS DEVICE IS INDICATED FOR TOPOGRAPHY-ASSISTED LASER- ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENT USING THE FINAL FIT CUSTOM ABLATION TREATMENT PLANNING SOFTWARE FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS FROM -1.0 TO - 4.0 D OF SPHERE WITH ASTIGMATIC REFRACTIVE ERRORS FROM >-0.5 TO -2.0 D AT THE SPECTACLE PLANE; IN PATIENTS 21 YEARS OF AGE OR OLDER; AND, IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN +=0.5 D.
P040024|S078|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE / RESTYLANE-L, PERLANE, PERLANE-L(INJECTABLE GELS), RESTYLANE SILK|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2014|11/21/2014|||OK30|EXPANSION OF CLEANROOM F1 AT THE QMED FACILITY IN UPPSALA, SWEDEN.
P050051|S027|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB (LN 1L82)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2014|10/29/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A RAW MATERIAL USED IN THE MANUFACTURE OF THE ARCHITECT AUSAB REAGENT KIT.
P020004|S108|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2014|10/29/2014|||OK30|DUPLICATE THE SEWING CAPABILITY FOR CATHETER COMPONENT MANUFACTURING FROM THE FLAGSTAFF FACILITY AT THE PHOENIX FACILITY.
P020004|S109|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2014|10/29/2014|||OK30|DUPLICATE THE STENT WINDING PROCESS AND NEW TEMPERING OVENS AT THE SUNNYVALE FACILITY.
P880086|S248|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|ENDURITY FAMILY OF PACEMEKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2014|12/22/2014|||APPR|APPROVAL FOR THE ADDITION OF NON-FUNCTIONAL JUMPER CONNECTIONS FOR THE HYBRID ASSEMBLIES UTILIZED IN THE DEVICES.
P030035|S126|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ALLURE AND ALLURE QUADRA FAMILY OF CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2014|12/22/2014|||APPR|APPROVAL FOR THE ADDITION OF NON-FUNCTIONAL JUMPER CONNECTIONS FOR THE HYBRID ASSEMBLIES UTILIZED IN THE DEVICES.
P000008|S032|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/2014|11/05/2014|||APPR|APPROVAL FOR LABELING MODIFICATIONS TO 1) ADD IDENTIFIERS TO A PICTURE OF ACALIBRATION TUBE; AND (2) ADD A NOTE THAT THE USER SHOULD NOT OVERINFLATE THE BALLOON.
P100018|S013|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/2014|11/04/2014|||APPR|APPROVAL FOR THE MODIFICATION OF SAFETY INFORMATION IN THE LABELING.
P110010|S098|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2014|11/05/2014|||OK30|CHANGE THE BONDING PROCESS PARAMETERS USED TO CREATE THE BI-COMPONENT SUBASSEMBLY.
P100023|S109|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2014|11/05/2014|||OK30|CHANGE THE BONDING PROCESS PARAMETERS USED TO CREATE THE BI-COMPONENT SUBASSEMBLY.
P040047|S037|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2014|11/12/2014|||OK30|RELOCATION OF THE QUALITY INCOMING INSPECTION LAB, THE INSTALLATION OF THE QC CLEAN ROOM, AND THE INSTALLATION OF AN AUTOMATED TEMPERATURE/ HUMIDITY MONITORING SYSTEM.
P130021|S008|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE (R) SYSTEM|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/06/2014|12/10/2014|||APPR|APPROVAL FOR THE INTRODUCTION OF A REVISED CURSOR SPRING FOR THEACCUTRAK DELIVERY CATHETER SYSTEM (DCS).
P980035|S397|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2014|10/30/2014|||OK30|ADDITION OF A NEW HYBRID TESTER PLATFORM
P130009|S013|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|NOVAFLEX+ DELIVERY SYSTEM, ASCENDRA+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, ASCENDRA+ INTRODUCER SHE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2014|10/23/2014|||OK30|CHANGES TO THE SAMPLING PLAN FOR PRODUCT VERIFICATION TESTING OF THE DELIVERY SYSTEMS AND ACCESSORIES MANUFACTURED AT THE IRVINE, CALIFORNIA FACILITY.
P110021|S046|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2014|10/23/2014|||OK30|CHANGES TO THE SAMPLING PLAN FOR PRODUCT VERIFICATION TESTING OF THE DELIVERY SYSTEMS AND ACCESSORIES MANUFACTURED AT THE IRVINE, CALIFORNIA FACILITY.
P010012|S375|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|EASY TRAK 2 FAMILY|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2014|10/22/2014|||OK30|UPDATE THE PROXIMAL ELECTRODE LASER WELDING PARAMETERS FOR WELDING THE PROXIMAL ELECTRODE TO THE LEAD COIL.
P130008|S004|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATOR|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2014|11/06/2014|||OK30|INSTALL A NEW CURE AND PREHEAT OVEN AT THE CONTRACT MANUFACTURER¿S MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) LOCATION.
P110010|S099|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS - ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/08/2014|07/07/2015|||APPR|APPROVAL FOR THE ADDITION OF A NEW ANALYTICAL CHEMISTRY METHOD.
N970012|S100|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2014|11/06/2014|||OK30|IMPLEMENTATION OF TWO DUPLICATE CONVECTION OVENS.
P010030|S057|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2014|11/19/2014|||OK30|ALTERNATE COMPONENT SUPPLIERS FOR THE BATTERY CHARGER POWER SUPPLY AND THE STAINLESS STEEL ELECTRODE LAYER.
P120014|S001|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||Somatic gene mutation detection system|THXID-BRAF KIT|OWD|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2014|01/30/2015|||APPR|APPROVAL FOR A NEW DETERMINATION METHOD OF PLASMIDS AND TRANSCRIPTS CONCENTRATION DURING THE MANUFACTURING STEP (FGM/POL/ M00454), BY USING NANODROP UV-VIS SPECTROPHOTOMETER TO CHANGE FROM THE OLD METHOD UTILIZING STANDARD UV-VIS SPECTROPHOTOMETER.
P130009|S014|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/10/2014|10/23/2014|||OK30|CHANGE TO THE TESTING REQUIREMENTS FOR THE CRIMP AND EXPANSION TEST FOR THE VALVE FRAMES.
P950037|S143|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES, DEXTRUS, SETROX, TILDA, SAFIO|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/06/2014|||OK30|USE OF AN AUTOMATED PROCESS TO MEASURE THE RETRACTED AND EXTENDED LENGTHS AND ELECTRICAL RESISTANCE OF THE FIXATION HELIX USED IN THE LEADS.
P010013|S061|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/12/2014|||OK30|UPDATE AND CORRECTION ON INSTRUCTION AND PACKAGING PROCEDURES.
P040037|S074|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/14/2014|01/08/2015|||APPR|APPROVAL FOR THE ADDITION OF A 7.5 CM ENDOPROSTHESIS LENGTH IN 5-8 MM AND 9 MM DIAMETER CONFIGURATIONS, WITH AND WITHOUT HEPARIN, ON BOTH THE 0.035 GUIDEWIRE CATHETER (75CM AND 120CM LENGTH) AND THE 0.014/0.018 GUIDEWIRE CATHETER (120CM LENGTH).
P130006|S014|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/14/2014|01/08/2015|||APPR|APPROVAL FOR THE ADDITION OF A 7.5 CM ENDOPROSTHESIS LENGTH IN 5-8 MM AND 9 MM DIAMETER CONFIGURATIONS, WITH AND WITHOUT HEPARIN, ON BOTH THE 0.035 GUIDEWIRE CATHETER (75CM AND 120CM LENGTH) AND THE 0.014/0.018 GUIDEWIRE CATHETER (120CM LENGTH).
P010031|S472|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|10/23/2014|||OK30|REDUCTION IN THE WELD MONITORING FREQUENCY OF THE BATTERY.
P890003|S324|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|10/23/2014|||OK30|REDUCTION IN THE WELD MONITORING FREQUENCY OF THE BATTERY.
P980016|S508|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|10/23/2014|||OK30|REDUCTION IN THE WELD MONITORING FREQUENCY OF THE BATTERY.
P980035|S398|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|10/23/2014|||OK30|REDUCTION IN THE WELD MONITORING FREQUENCY OF THE BATTERY.
P070026|S024|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX (R) CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/14/2014|03/18/2015|||APPR|APPROVAL FOR THE FOR THE INCLUSION OF THE SUMMIT® POROCOAT® FEMORAL PROSTHESIS, THE PINNACLE® 300 SERIES, MULTI-HOLE AND SECTOR II ACETABULAR SHELLS AND THE TAMP EXTRACTOR MANUAL SURGICAL INSTRUMENT FOR THE NEWLY ENROLLED PATIENTS STUDY ARM TO THE POST-APPROVAL STUDY PROTOCOL.
P070026|S025|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX (R) CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/14/2014|03/10/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: PATIENTS WITH ANY OF 5 DIFFERENT STEMS TO PARTICIPATE TO FACILITATE PATIENT ENROLLMENT AND REMOVING ACETABULAR SHELLS FROM THIS PAS PROTOCOL.
P070026|S026|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX (R) CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/14/2014|03/12/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010014|S049|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/13/2014|||OK30|ADDITION OF NEW MANUFACTURING EQUIPMENT.
P990046|S039|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|MEDTRONIC OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/13/2014|||OK30|UPGRADE TO A CURRENT COMPONENT SOFTWARE APPLICATION.
P010032|S086|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI, PROTEGE AND PROTEGE MRI IPGS (3788. 3789, & 3771)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/13/2014|||OK30|IMPLEMENT MANUFACTURING PROCESS CHANGES.
P040037|S075|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/14/2014|04/03/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P970031|S048|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS(MODELS 995, 995CS, 995MS)|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/12/2014|||OK30|ADDITION OF TWO NEW PORCINE TISSUE SUPPLIERS.
P990064|S059|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS- (MODELS 305. 310)|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/12/2014|||OK30|ADDITION OF TWO NEW PORCINE TISSUE SUPPLIERS.
P980043|S050|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS- (MODELS T505, T510)|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/12/2014|||OK30|ADDITION OF TWO NEW PORCINE TISSUE SUPPLIERS.
P870078|S028|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT (MODEL 105)|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/12/2014|||OK30|ADDITION OF TWO NEW PORCINE TISSUE SUPPLIERS.
P790007|S044|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT-(MODEL 150)|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2014|11/12/2014|||OK30|ADDITION OF TWO NEW PORCINE TISSUE SUPPLIERS.
P960040|S336|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NG3 FAMILY OF ICD'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF ICD'S (INCEPTA, ENERGEN, & PUNCTUA)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/2014|01/29/2015|||APPR|APPROVAL FOR IMPROVEMENTS AND MODIFICATIONS TO THE NG3 AND PROGENY ICD AND CRT-D DEVICES.
P010012|S376|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|NG3 FAMILY OF CRT-D'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF CRT-D'S (INCEPTA, ENERGEN, & PUNCTUA)|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/15/2014|01/29/2015|||APPR|APPROVAL FOR IMPROVEMENTS AND MODIFICATIONS TO THE NG3 AND PROGENY ICD AND CRT-D DEVICES.
P120014|S002|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||Somatic gene mutation detection system|THXID BRAF KIT|OWD|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2014|12/22/2014|||APPR|APPROVAL FOR THE FOLLOWING SEVEN CHANGES: CLEANING OF DRIPPING AND SPHERES FILLING EQUIPMENT, TRANSFER OF QUALITY CONTROL ACTIVITIES INTO ANOTHER ROOM, RAW MATERIAL CHANGES FOR BOTTLES AND CAPS FOR THXID-BRAF PUR, MODIFICATION OF A FUNCTIONAL QUALITY CONTROL (QC) TEST FOR THE THXIDTM-BRAF PUR KIT, TRANSFER OF BUFFER MANUFACTURING (FOR THE BRAF PURIFICATION KIT) INTO A NEW BUILDING AT QIAGEN, CHANGES IN DNASE REFERENCE (AM2224) USED IN THE DETERMINATION OF DNASE ACTIVITY IN WATER AND REAGENTS, AND SHELF LIFE EXTENSION FOR RNA TRANSCRIPTS AND PLASMIDS.
P080006|S075|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN PERFORMA QUADRIPOLAR LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2014|10/30/2014|||OK30|REPLACE THE MANUAL RECORDING SYSTEM FOR MONITORING TEMPERATURE, HUMIDITY AND ANALOG GAUGES FOR MONITORING DIFFERENTIAL PRESSURE WITH AN AUTOMATED MONITORING SYSTEM.
P900061|S132|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ACE HEADER|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2014|10/30/2014|||OK30|REPLACE THE MANUAL RECORDING SYSTEM FOR MONITORING TEMPERATURE, HUMIDITY AND ANALOG GAUGES FOR MONITORING DIFFERENTIAL PRESSURE WITH AN AUTOMATED MONITORING SYSTEM.
P920015|S145|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TUNNELING TOOL|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2014|10/30/2014|||OK30|REPLACE THE MANUAL RECORDING SYSTEM FOR MONITORING TEMPERATURE, HUMIDITY AND ANALOG GAUGES FOR MONITORING DIFFERENTIAL PRESSURE WITH AN AUTOMATED MONITORING SYSTEM.
P020056|S029|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/15/2014|01/16/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: RE-OP PHASE PROTOCOL AS A NEW POST-APPROVAL STUDY REQUIREMENT.
P000006|S038|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/15/2014|11/04/2014|||APPR|APPROVAL FOR LABELING CHANGES TO STRENGTHEN EXISTING INSTRUCTIONS ON PUMP FILLING AND ACTIVATION.
P100031|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC ON COBAS E 601|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2014|11/26/2014|||APPR|APPROVAL FOR SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE.
P110022|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ON COBAS E 601|LOM|MI|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/16/2014|11/26/2014|||APPR|APPROVAL FOR SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE.
P110025|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2014|11/26/2014|||APPR|APPROVAL FOR SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE.
P130015|S002|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBEAG ON MODULAR ANALYTICS E170|LOM|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2014|11/26/2014|||APPR|APPROVAL FOR SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE.
P980040|S051|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2014|11/12/2014|||OK30|ADDING AN ALTERNATE MOLDING SUPPLIER FOR THE CARTRIDGE COMPONENT USED IN THE TECNIS ITEC PRELOAD DELIVERY SYSTEM.
P040046|S012|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/16/2014|08/03/2015|||APPR|APPROVAL FOR THE REDESIGN OF THE POST APPROVAL STUDY PROTOCOL.
P020002|S009|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP IMAGING SYSTEM|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2014|01/12/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE REVIEW SCOPE MANUAL PLUS MICROSCOPE FRAME OF THE THINPREP IMAGING SYSTEM.
P020045|S064|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CRYOCONSOLE|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/16/2014|05/11/2015|||APPR|APPROVAL FOR ROHS DESIGN AND CONTROL CHANGES TO GEN V CRYOCONSOLE MODEL 106A3.
P860057|S129|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS; RSR, THEON RSR WITH|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2014|11/14/2014|||OK30|NEW ENCLOSURE AND EQUIPMENT TO BE USED IN THE PARTICULATE EVALUATION PROCESS OF COMPONENTS.
P100041|S060|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2014|11/14/2014|||OK30|NEW ENCLOSURE AND EQUIPMENT TO BE USED IN THE PARTICULATE EVALUATION PROCESS OF COMPONENTS.
P110021|S047|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2014|11/14/2014|||OK30|NEW ENCLOSURE AND EQUIPMENT TO BE USED IN THE PARTICULATE EVALUATION PROCESS OF COMPONENTS.
P130009|S015|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2014|11/14/2014|||OK30|NEW ENCLOSURE AND EQUIPMENT TO BE USED IN THE PARTICULATE EVALUATION PROCESS OF COMPONENTS.
P980022|S162|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2014|11/21/2014|||OK30|CHANGES TO THE FABRICATION PROCESS FOR THE SOF-SENSOR (MMT-7002). THE SOF-SENSOR IS A COMPONENT OF THE CONTINUOUS GLUCOSE MONITORING SYSTEM, PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, IPRO RECORDER CGM SYSTEM, AND IPRO 2 PROFESSIONAL CGM SYSTEM.
P030017|S206|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STUMULATOR (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2014|03/31/2015|||APPR|ADDITIONAL MATERIAL SUPPLIER.
P030017|S207|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2014|11/14/2014|||OK30|DEVICE TEST FIXTURE MODIFICATION.
P120006|S016|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRI VASCULAR, INC. OVATION /OVATION ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2014|11/20/2014|||OK30|MODIFIED AND NEW TOOLS FOR USE IN THE PROCESS FOR LOADING THE STENT GRAFTS INTOTHE DELIVERY SYSTEM SHEATHS.
P980040|S052|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZBM00, SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2014|11/21/2014|||OK30|ADDITION OF A NEW PURIFIED WATER SYSTEM AND A NEW AIR-HANDLING UNIT SYSTEM.
P980040|S053|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||SENSAR 1-PIECE LENS MODEL AAB00||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2014|11/15/2014|||OK30|CHANGE FROM MACHINED TO A MOLDED IOL EDGE BLOCKER, CHANGE IN CYCLE TIME FOR THE IOL TUMBLING PROCESS, ADDITION OF A COSMETIC INSPECTION FOLLOWINGSTERILIZATION, CHANGE IN TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF IOLS, ANDNEW ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY EQUIPMENT FOR TESTING RESIDUAL MONOMER LEVELS OF IOL SOFT ACRYLIC MATERIAL.
P120010|S037|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2014|11/19/2014|||OK30|ADDITION OF EQUIPMENT USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G INSULIN PUMPS THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM, THE PARADIGM REAL-TIME REVEL SYSTEM, AND THE MINIMED 530G SYSTEM.
P120016|S007|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2014|11/17/2014|||OK30|SEMI-AUTOMATION OF THE COLLAGEN COMPRESSION PROCESS.
P910023|S346|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE/FORTIFY ASSURA FAMILY OS ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2014|12/11/2014|||APPR|APPROVAL FOR MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES.
P980022|S163|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2014|11/19/2014|||OK30|ADDITION OF EQUIPMENT USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G INSULIN PUMPS THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM, THE PARADIGM REAL-TIME REVEL SYSTEM, AND THE MINIMED 530G SYSTEM.
P030054|S276|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2014|12/11/2014|||APPR|APPROVAL FOR MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES.
P030035|S127|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2014|12/11/2014|||APPR|APPROVAL FOR MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES.
P880086|S249|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFFINITY/INTEGRITY/VICTORY/ZEPHR/ACCENT FAMILY OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/20/2014|12/11/2014|||APPR|APPROVAL FOR MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES.
N970012|S101|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS (IPP)|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2014|11/18/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL TRAY SEALER.
P000053|S052|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM (AUS)|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2014|11/18/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL TRAY SEALER.
P010020|S028|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTION  NEOSPHINCTER ARTIFICIAL BOWL SPHINCTER (ABS)|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2014|11/18/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL TRAY SEALER.
P870076|S014|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING BAND AND APPLICATOR SYSTEMS|KNH|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2014|11/17/2014|||APPR|APPROVAL FOR LABELING CLARIFICATIONS REGARDING NOT LOADING DEVICES MORE THAN THIRTY MINUTES BEFORE USE, AND REDUCING LANGUAGES IN DEVICE LABELING TO ONLY ENGLISH AND FRENCH.
P980022|S164|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MINILINK REAL-TIME TRASMITTER, IPRO2 DIGITAL RECORDER|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2014|12/04/2014|||OK30|IMPLEMENTATION OF FIVE ADDITIONAL PIECES OF EQUIPMENT AT A CONTRACT MANUFACTURER TO SUPPORT THE MANUFACTURE OF THE LITHIUM POLYMER BATTERIES FOR THE MINILINKREAL-TIME TRANSMITTER MODEL NUMBER MMT-7703 AND THE IPRO2 DIGITAL RECORDER MODEL NUMBER MMT-7741. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL?] TIME SYSTEM, PARADIGM REAL?] TIME REVEL SYSTEM, GUARDIAN REAL?]TIME SYSTEM, MINILINKREAL?]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM. THE IPRO2 RECORDER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM.
P120006|S017|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRIVASCULAR, INC OVATION/OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2014|01/14/2015|||APPR|APPROVAL FOR A MODIFICATION TO THE CUSTOMSEAL KIT.
P810006|S057|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2014|11/18/2014|||OK30|UPDATING THE OPERATIONAL PARAMETERS OF A SEALING MACHINE USED IN THE COLLAGEN AREA AT INTEGRA NEUROSCIENCES FACILITY IN ANASCO, PUERTO RICO FOR THE DEVICES.
P990075|S028|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED AND SPECTRUM MAMMARY PROSTHESES|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2014|11/19/2014|||OK30|CHANGE TO ADD AN ALTERNATE SUPPLIER FOR ISOPROPYL ALCOHOL (IPA) USED IN THE PRODUCTION OF SPECTRUM AND SALINE-FILLED BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.
P120010|S038|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2014|11/21/2014|||OK30|CHANGE IN THE SENSOR ASSEMBLY MANUFACTURING PROCESS AND AN ALTERNATE SUPPLIER FOR THE NEEDLE HUB ASSEMBLY.
P020050|S018|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/23/2014|01/20/2015|||APPR|APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM.
P030008|S016|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/23/2014|01/20/2015|||APPR|APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM.
P960009|S210|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2014|11/21/2014|||OK30|ADDITION OF NEW INSPECTION EQUIPMENT.
P970003|S173|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY ASPIRESR|LYJ|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/23/2014|05/29/2015|||APPR|APPROVAL FOR THE MODEL 106 ASPIRESR GENERATOR AND MODEL 250 VERSION 11.0.5 PROGRAMMING SOFTWARE.
P040037|S076|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN, ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2014|11/21/2014|||OK30|MODIFICATIONS TO THE STRIPPING MACHINE USED DURING REMOVAL OF GRAFT COMPONENTS FROM THE PROCESS MANDREL.
P130006|S015|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2014|11/21/2014|||OK30|MODIFICATIONS TO THE STRIPPING MACHINE USED DURING REMOVAL OF GRAFT COMPONENTS FROM THE PROCESS MANDREL.
P880086|S250|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ACCENT, ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAKERS|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/21/2014|||OK30|USE OF A REFLOW OVEN TO CURE EPOXY ON THE HYBRID AND RF MODULE ASSEMBLIES.
P030035|S128|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ALLURE AND ALLURE QUADRA FAMILY OF CRT-P|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/21/2014|||OK30|USE OF A REFLOW OVEN TO CURE EPOXY ON THE HYBRID AND RF MODULE ASSEMBLIES.
P010033|S025|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON- TB GOLD TEST|NCD|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2014|12/04/2014|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN IN GERMANTOWN, MARYLAND.
P910023|S347|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, CURRENT ACCEL, CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/21/2014|||OK30|USE OF A REFLOW OVEN TO CURE EPOXY ON THE HYBRID AND RF MODULE ASSEMBLIES.
P030054|S277|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUADRA, PROMOTE +, QUADRA ASSURA, UNIFY, UNIFY ASSURA AND UNIFY QUADRA FAMILY|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/21/2014|||OK30|USE OF A REFLOW OVEN TO CURE EPOXY ON THE HYBRID AND RF MODULE ASSEMBLIES.
P960058|S112|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/28/2014|05/19/2015|||APPR|APPROVAL FOR CHANGES TO THE DESIGN AND MANUFACTURE OF THE HIFOCUS MID-SCALA (HFMS) INSERTION TOOLS.
P080026|S012|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV ASSAY|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2014|11/20/2014|||OK30|CHANGE TO ADD A SINGLE, AUTOMATED BOTTLING LINE FOR COMPONENT FILLING AND CAPPING.
P100017|S010|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REAL TIME HCV ASSAY, ABBOTT REAL TIME HCV CALIBRATOR KIT AND CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2014|11/20/2014|||OK30|CHANGE TO ADD A SINGLE, AUTOMATED BOTTLING LINE FOR COMPONENT FILLING AND CAPPING.
P120012|S005|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2014|11/20/2014|||OK30|CHANGE TO ADD A SINGLE, AUTOMATED BOTTLING LINE FOR COMPONENT FILLING AND CAPPING.
P990004|S025|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN|LMF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/24/2014|05/16/2016|||APPR|Approval for a packaging change to introduce a new packaging configuration for the Thrombin Kit Package for SURGIFLO Hemostatic Matrix Kit with Thrombin.  This change was requested for the manufacturing site located at SteriPack Medical Poland SP. ZO.O., Poland, for the contract packaging of the SURGIFLO Hemostatic Matrix Device and the sterilizing  site located at Synergy Health Ede BV, Netherlands, for the sterilization of the SURGIFLO Hemostatic Matrix Device.
P100027|S020|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|12/04/2014|||OK30|CHANGE IN THE MANUFACTURING PARAMETERS FOR THE VENTANA REAGENT DISPENSER VENT SEAL.
P020055|S016|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|12/04/2014|||OK30|CHANGE IN THE MANUFACTURING PARAMETERS FOR THE VENTANA REAGENT DISPENSER VENT SEAL.
P990081|S031|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|12/04/2014|||OK30|CHANGE IN THE MANUFACTURING PARAMETERS FOR THE VENTANA REAGENT DISPENSER VENT SEAL.
P990075|S029|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT|FWM|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|10/27/2014|11/26/2014|||APPR|APPROVAL FOR MODIFICATIONS TO THE WINGED INFUSION SET ACCESSORY OF THE MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT. THE MODIFICATIONS INCLUDED: 1. TEXTURE, BEVELED EDGES, AND A FINGER HOLE WAS ADDED TO EACH (2) SIDE OF THE WING DESIGN; 2. PHTHALATE WAS ELIMINATED FROM THE WING MATERIAL: PVC NAKAN FEM 828 N N WITH DEHP WITH COLORANT MASTERBATCH PVC 9154 GREEN TO PVC NAKAN FEM 828 N N WITH DEHT WITH COLORANT MASTERBATCH PVC 9154 GREEN; AND3. PHTHALATE WAS ELIMINATED FROM THE TUBING MATERIAL: PVC NAKAN FMA 748 N N WITH DEHP TO PVC NAKAN FMA 748 N N WITH DEHT.
P000040|S034|Boston Scientific Corp.|100 BOSTON SCIENTIFIC WAY|MB 21|MARLBOROUGH|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|GENESYS HTA SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/25/2014|||OK30|REMOVAL OF THE IN-PROCESS BURST TEST FOR THE SHEATH ASSEMBLY TRAY.
P860004|S216|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/17/2014|||OK30|MOVE OF A SUPPLIER MANUFACTURING LINE.
P100049|S011|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/2014|01/21/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE INTERNAL MAGNETS AND WIRE LINKS CONNECTING THE BEADS, AS WELL AS ASSOCIATED MODIFICATIONS TO THE LABELING, ALLOWING THE DEVICE TO BE MAGNETIC RESONANCE (MR) CONDITIONAL UP TO 1.5 TESLA.
P030017|S208|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/26/2014|||OK30|IMPLEMENT AN ALTERNATIVE BONDING METHOD.
P000058|S057|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT LUMBAR TAPERED FUSION DEVICE|NEK|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|04/24/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WYETH FARMA, S.A., IN MADRID, SPAIN.
P000054|S043|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|04/24/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WYETH FARMA, S.A., IN MADRID, SPAIN.
P050053|S034|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132|||INFUSE BONE GRAFT||DE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|04/24/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT WYETH FARMA, S.A., IN MADRID, SPAIN.
P120005|S029|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/26/2014|||OK30|CHANGE IN THE SOLDER MASK PATTERN OF THE RADIO FREQUENCY TRANSCEIVER, WHICHIS A COMPONENT OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
N970003|S168|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO, FORMIO PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/17/2014|||OK30|MODIFY THE CRYSTAL OSCILLATOR MANUFACTURING PROCESS AT AN EXISTING SUPPLIER FOR THE DEVICES.
P030005|S114|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE CRT-PS, INTUA CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/17/2014|||OK30|MODIFY THE CRYSTAL OSCILLATOR MANUFACTURING PROCESS AT AN EXISTING SUPPLIER FOR THE DEVICES.
P980022|S165|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/26/2014|||OK30|CHANGE FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS FOR A TEST CARRIEDOUT DURING ACCEPTANCE TESTING OF THE PARADIGM® REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K); PARADIGM® REAL-TIME REVEL INSULIN PUMP (MODELS:MMT-523, MMT-523K, MMT-723, MMT-723K); MINIMED 530G INSULIN PUMP (MODELS:MMT-551, MMT-751) CASES. THE PARADIGM® REAL-TIME, PARADIGM® REAL-TIME REVEL, ANDMINIMED 530G INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM® REAL-TIME SYSTEM,PARADIGM® REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM, RESPECTIVELY.
P120010|S039|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2014|11/26/2014|||OK30|CHANGE FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS FOR A TEST CARRIEDOUT DURING ACCEPTANCE TESTING OF THE PARADIGM® REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K); PARADIGM® REAL-TIME REVEL INSULIN PUMP (MODELS:MMT-523, MMT-523K, MMT-723, MMT-723K); MINIMED 530G INSULIN PUMP (MODELS:MMT-551, MMT-751) CASES. THE PARADIGM® REAL-TIME, PARADIGM® REAL-TIME REVEL, ANDMINIMED 530G INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM® REAL-TIME SYSTEM,PARADIGM® REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM, RESPECTIVELY.
P070014|S047|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/27/2014|04/23/2015|||APPR|APPROVAL FOR DELIVERY SYSTEM MODIFICATIONS.
P100021|S041|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT AND ENDURANT II STENT SYSTEM, ENDURANT II AORTO-UNI-LLIAC(AUI) STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/28/2014|01/22/2015|||APPR|APPROVAL FOR REVISION OF THE DELIVERY SYSTEM GRAFT COVER TENSILESPECIFICATION.
P000058|S058|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE(R) BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE|NEK|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/29/2014|01/27/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE PACKAGE INSERT AND PATIENT INFORMATIONBROCHURE (MODIFICATION OF THIS DOCUMENT WAS SUBSEQUENTLY WITHDRAWN) AS FOLLOWS:1) ADDITION OF WARNING AND PRECAUTION LANGUAGE RELATED TO DATA GENERATED FROM YOUR CERVICALSPINE STUDY; 2) CLARIFICATION TO THE POSTERIOR BONE FORMATION PRECAUTION; 3) REVISION TO THE RETROGRADE EJACULATION WARNING LANGUAGE; 4) ORGANIZATION OF THE WARNINGS INTO SIMILAR GROUPS OF ISSUES;5) REPLACEMENT OF ECTOPIC BONE FORMATION WITH HETEROTOPIC OSSIFICATION; 6) ADDITION OF SEVERAL ADDITIONAL POTENTIAL ADVERSE EVENTS; AND7) ALPHABETIZATION OF THE POTENTIAL ADVERSE EVENTS.
P030031|S063|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/30/2014|11/19/2014|||APPR|APPROVAL FOR MINOR LABELING CHANGES.
P980022|S166|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2014|05/13/2015|||APPR|APPROVAL FOR A CHANGE IN THE CALCULATION METHOD USED TO DETERMINE THE AMOUNT OF PLATINUM TO ADD IN THE MANUFACTURE OF THE PLATINUM SOLUTION USED IN THE FABRICATION PROCESS FOR THE SOF-SENSOR AND ENLITE SENSORS, AND FOR THE ENLITE SENSOR ONLY, THE ADDITION OF EQUIPMENT USED TO VERIFY THE PLATINUM SOLUTION CONCENTRATION.
P120010|S040|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2014|05/13/2015|||APPR|APPROVAL FOR A CHANGE IN THE CALCULATION METHOD USED TO DETERMINE THE AMOUNT OF PLATINUM TO ADD IN THE MANUFACTURE OF THE PLATINUM SOLUTION USED IN THE FABRICATION PROCESS FOR THE SOF-SENSOR AND ENLITE SENSORS, AND FOR THE ENLITE SENSOR ONLY, THE ADDITION OF EQUIPMENT USED TO VERIFY THE PLATINUM SOLUTION CONCENTRATION.
P040044|S058|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2014|11/25/2014|||OK30|
P040036|S047|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/30/2014|11/19/2014|||APPR|APPROVAL FOR MINOR LABELING CHANGES.
P120010|S041|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2014|01/28/2015|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE SENSOR BASE, O-RING, TAPE, ADHESIVE AND SENSOR PATCH OF THE ENLITE GLUCOSE SENSOR (MMT-7008A, MMT-7008B) IN ORDER TO SUPPORT MANUFACTURING CHANGES FROM A MANUAL ASSEMBLY PROCESS TO AN AUTOMATED ASSEMBLY LINE FOR THE ENLITE GLUCOSE SENSOR. THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530GSYSTEM.
P980022|S167|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SOF-SENSOR|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2014|01/29/2015|||APPR|APPROVAL FOR USE OF A THICKER DOUBLE-SIDED TAPE ON THE SOF-SENSOR (MODEL MMT-7002, MMT-7003 AND ENLITE SENSOR (MMT-7008) BASE AS WELL AS CHANGE IN THECONVERTER/DISTRIBUTOR OF THE TAPE.  THE SOF-SENSOR (MODEL MMT-7002, MMT-7003) IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, AND IPRO2 PROFESSIONAL CGM SYSTEMS AND THE ENLITE GLUCOSE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P120010|S042|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2014|01/29/2015|||APPR|APPROVAL FOR USE OF A THICKER DOUBLE-SIDED TAPE ON THE SOF-SENSOR (MODEL MMT-7002, MMT-7003 AND ENLITE SENSOR (MMT-7008) BASE AS WELL AS CHANGE IN THECONVERTER/DISTRIBUTOR OF THE TAPE.  THE SOF-SENSOR (MODEL MMT-7002, MMT-7003) IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, AND IPRO2 PROFESSIONAL CGM SYSTEMS AND THE ENLITE GLUCOSE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P950037|S144|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI;|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2014|11/21/2014|||OK30|CHANGES TO EQUIPMENT USED IN THE PRODUCTION OF IS-1 CONNECTOR PORTS.
P050023|S082|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4)|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2014|11/21/2014|||OK30|CHANGES TO EQUIPMENT USED IN THE PRODUCTION OF IS-1 CONNECTOR PORTS.
P070008|S058|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ELUNA 8 HF-T; ENTOVIS HF, ENTOVIS HF-T, EPYRA 8 HF-T|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2014|11/21/2014|||OK30|CHANGES TO EQUIPMENT USED IN THE PRODUCTION OF IS-1 CONNECTOR PORTS.
P980022|S168|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|GUARDIAN REAL TIME MONITOR|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|10/31/2014|01/28/2015|||APPR|APPROVAL FOR AN ALTERNATE SUPER CAPACITOR, A COMPONENT USED ON THE INTERFACE BOARDS OF THE GUARDIAN REAL-TIME MONITORS (MODELS CSS7100 AND CSS7100K)WHICH ARE COMPONENTS OF THE GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM.
P980022|S169|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|MYSENTRY  SYSTEM ; MYSENTRY MONITOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2014|11/26/2014|||OK30|CHANGE TO THE MOLD USED IN THE MANUFACTURING OF THE USB CONNECTOR, A COMPONENT IN THE MYSENTRY MONITOR THAT IS USED TO RECEIVE DATA FROM THE PARADIGM REAL-TIME  REVEL SYSTEM.
P970018|S030|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD  TOTALYS SLIDEPREP|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2014|02/12/2016|||APPR|Approval for the BD Totalys™ SlidePrep (and use of the BD FocalPoint™ Slide Profiler with slides prepared by the BD Totalys™ SlidePrep). The devices, as modified, will be marketed under the trade names BD Totalys™ SlidePrep and BD FocalPoint™ Slide Profiler, respectively.
P980022|S170|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMPS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2014|12/03/2014|||OK30|CHANGE TO A REJECTION CRITERION IN THE HARVEST OF USED MOTORS DURING THEMANUFACTURING OF REFURBISHED PUMPS. THE MOTOR IS A PART OF THE INSULIN PUMP IN THE PARADIGMREAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), THE PARADIGM REALTIMEREVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), AND THE MINIMED 530G SYSTEM (MMT-551, MMT-751).
P120010|S043|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMPS|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2014|12/03/2014|||OK30|CHANGE TO A REJECTION CRITERION IN THE HARVEST OF USED MOTORS DURING THEMANUFACTURING OF REFURBISHED PUMPS. THE MOTOR IS A PART OF THE INSULIN PUMP IN THE PARADIGMREAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), THE PARADIGM REALTIMEREVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), AND THE MINIMED 530G SYSTEM (MMT-551, MMT-751).
P000053|S053|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/03/2014|01/28/2015|||APPR|APPROVAL FOR THE USE OF (I) THE ZONE OF INHIBITION (ZOI) AS THE SHELF LIFE INDICATION FACTOR AND TO CONSISTENTLY USE (II) A TWO YEAR SHELF LIFE FOR INHIBIZONE® (IZ) TREATED DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMS 800 ARTIFICIAL URINARY SPHINCTER (AMS 800). THE DEVICE IS USED TO TREAT URINARY INCONTINENCE DUE TO REDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY.  THE AMS 700 INFLATABLE PENILE PROSTHESIS (AMS 700) IS USED IN THE TREATMENT OF CHRONIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE).
N970012|S102|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/03/2014|01/28/2015|||APPR|APPROVAL FOR THE USE OF (I) THE ZONE OF INHIBITION (ZOI) AS THE SHELF LIFE INDICATION FACTOR AND TO CONSISTENTLY USE (II) A TWO YEAR SHELF LIFE FOR INHIBIZONE® (IZ) TREATED DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMS 800 ARTIFICIAL URINARY SPHINCTER (AMS 800). THE DEVICE IS USED TO TREAT URINARY INCONTINENCE DUE TO REDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY.  THE AMS 700 INFLATABLE PENILE PROSTHESIS (AMS 700) IS USED IN THE TREATMENT OF CHRONIC, MALEERECTILE DYSFUNCTION (IMPOTENCE).
P980022|S171|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|SEN-SERTER|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2014|12/03/2014|||OK30|CHANGE IN THE CURING TIME DURING THE MANUFACTURING PROCESS FOR THE SENSERTER, WHICH IS A COMPONENT OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVELSYSTEM, GUARDIAN REAL-TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, AND IPRO2PROFESSIONAL CGM SYSTEM.
P050006|S044|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE CARDIOFORM SEPTAL OCCLUDER|MLV|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2014|04/30/2015|||APPR|APPROVAL FOR ADDITION OF THE GORE CARDIOFORM SEPTAL OCCLUDER TO THE GORE HELEX SEPTAL OCCLUDER LINE.
P910023|S348|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/2014|01/13/2015|||APPR|APPROVAL FOR MERLIN.NET MN5000 V7.2 SOFTWARE USED WITH THE DEVICES.
P950037|S145|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SETROX S LEAD, DEXTRUS, TILDA R, SAFIO S.|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2014|12/03/2014|||OK30|ALTERNATIVE ASSEMBLY PROCESS FOR PACEMAKER LEADS.
P100047|S051|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2014|12/04/2014|||OK30|AUTOMATE VARIOUS MANUFACTURING PROCESSES
P860004|S217|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2014|09/29/2015|||APPR|APPROVAL FOR CHANGES AFFECTING A GEAR TRAIN COMPONENT (GEAR WHEEL 3) AS WELL AS A MINOR DIMENSIONAL CHANGE TO GEAR WHEEL 3 TO ENABLE MANUFACTURING.
P080011|S032|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFLICON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2014|12/17/2014|||OK30|APPROVAL FOR THE USE OF AN ALTERNATE PICK HEAD MATERIAL, FOR THE MANUFACTURE OF COMFILCON A EXTENDED-WEAR CONTACT LENSES.
P100023|S110|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- OVER THE WIRE; ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM-MONORAIL|NIQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/03/2014|12/18/2014|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P030035|S129|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/2014|01/13/2015|||APPR|APPROVAL FOR MERLIN.NET MN5000 V7.2 SOFTWARE USED WITH THE DEVICES.
P030054|S278|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/2014|01/13/2015|||APPR|APPROVAL FOR MERLIN.NET MN5000 V7.2 SOFTWARE USED WITH THE DEVICES.
P110042|S042|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2014|11/25/2014|||OK30|TO DISPOSITION NON-CONFORMING FEEDTHRUS AT RECEIVING INSPECTION.
P050047|S042|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JEVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/03/2014|11/19/2014|||APPR|APPROVAL FOR THE STRENGTHENING OF THE CURRENT WARNING AND THE DISCUSSION OF THE POTENTIAL ADVERSE REACTION(S) ASSOCIATED WITH VASCULAR INJECTION.
P110033|S012|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/03/2014|11/19/2014|||APPR|APPROVAL FOR THE ADDITION OF A PRECAUTION REGARDING COMPLIANCE WITH NEEDLE ATTACHMENT INSTRUCTIONS.
P110006|S004|U-SYSTEMS, INC.|9900 WEST INNOVATIVE DRIVE|MAIL STOP RP2138|WAUWATOSA|WI|53226||Automated breast ultrasound|INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM|PAA|RA|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/2014|11/24/2014|||APPR|APPROVAL OF A CHANGE IN THE DEVICE DESIGN TO ACCOMMODATE A NEW DEVICE CONFIGURATION. THE NEW DEVICE CONFIGURATION CONSISTS OF THE FOLLOWING COMPONENTS: INVENIA ABUS SCAN STATION, INVENIA ABUS REVIEW SOFTWARE, AND USER COMPUTER/ WORK STATION THAT IS QUALIFIED TO MEET A REQUIRED SET OF HARDWARE AND SOFTWARE SPECIFICATION. IN ADDITION TO THE PROPOSED ADDITIONAL DEVICE CONFIGURATION, YOUR SUPPLEMENT REQUESTED APPROVAL OF MINOR SOFTWARE UPDATES TO ADDRESS ISSUES DISCOVERED THROUGH INTERNAL TESTING AND CUSTOMER FEEDBACK. THESE CHANGES INCLUDE MARKER POSITIONING ON IMAGES, DICOM-RELATED IMAGE CONTENT, AND GENERAL IMAGE FORMATTING, PROCESSING, AND TRANSFER. YOUR SUPPLEMENT ALSO REQUESTED LABELING CHANGES ASSOCIATED WITH THE ABOVE-SPECIFIED DEVICE CHANGE, SPECIFICALLY IN WORKSTATION USER MANUAL, SYSTEM SETUP AND BASIC SERVICE MANUAL, AND SCAN STATION MANUAL.
P880086|S251|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/03/2014|01/13/2015|||APPR|APPROVAL FOR MERLIN.NET MN5000 V7.2 SOFTWARE USED WITH THE DEVICES.
P850048|S040|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA ASSAY|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2014|03/20/2015|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.
P970038|S029|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2014|03/20/2015|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.
P980041|S030|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP IMMUNOASSAY SYSTEM|LOK|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2014|03/20/2015|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.
P000012|S050|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0, COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2014|12/04/2014|||OK30|DISCONTINUATION OF AN IN-PROCESS QC TEST.
P090026|S014|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM|OYA|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2014|03/20/2015|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.
P970021|S042|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2014|12/04/2014|||OK30|MANUFACTURING CHANGES TO THE GYNECARE THERMACHOICE II CONTROLLER TO MEET AND COMPLY WITH THE EUROPEAN RESTRICTION OF HAZARDOUS SUBSTANCES (ROHS) DIRECTIVE2011/65/EU BY REPLACING NON-ROHS COMPLIANT COMPONENTS WITH FUNCTIONALLY EQUIVALENT ROHS COMPLIANT COMPONENTS.
P980022|S172|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, GUARDIAN REAL-TIME MONITOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2014|12/05/2014|||OK30|ADDITIONAL MANUFACTURING TESTING TO BE PERFORMED ON A PREVIOUSLY APPROVEDCOMPONENT USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-522,MMT-522K, MMT-722, MMT-722K) AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS(MMT-523, MMT-523K, MMT-723, MMT-723K) THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL SYSTEM RESPECTIVELY. THIS COMPONENT IS ALSO USED IN THE GUARDIAN REAL-TIME MONITOR (CSS7100, CS7100K) THAT IS PART OF THE GUARDIAN REALTIME SYSTEM.
P870076|S015|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|DISPOSABLE FALOPE RING BAND APPLICATOR KITS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2014|12/04/2014|||OK30|ADJUSTMENT OF THE SEALING PARAMETERS AND THE REPEAT OF A PEEL STRENGTH TEST AND VISUAL CHECK.
P100047|S052|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|12/11/2014|||OK30|ADD A MECHANIZED HVAD® HOUSING GLUING PROCESS FOR THE HEARTWARE® VENTRICULAR ASSIST SYSTEM.
P970031|S049|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|12/02/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P990064|S060|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|12/02/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P980043|S051|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|12/02/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P870078|S029|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|12/02/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P110032|S010|LOMBARD MEDICAL TECHNOLOGIES INC|15420 LAGUNA CANYON ROAD|SUITE 260|IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2014|02/03/2015|||APPR|APPROVAL FOR A LINE EXTENSION THAT WOULD INCLUDE TWO LARGER SIZE STENT GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE AND IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:  1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, IMPLANTS, AND ACCESSORIES.2) AORTIC NECK LANDING ZONE DIAMETERS WITH A RANGE OF 19 MM TO 33 MM.  3) NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF > 15 MM.  4) INFRARENAL AORTIC NECK ANGULATIONS INCLUDING THOSE UP TO AND INCLUDING 90°.  5) COMMON ILIAC LANDING ZONE DIAMETERS WITH A RANGE OF 9MM TO 19MM.  6) DISTAL FIXATION LENGTH OF > 15 MM.
P790007|S045|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|12/02/2014|||OK30|ADDITION OF A NEW PORCINE TISSUE SUPPLIER.
P010031|S473|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D'S BRAVA QUAD CRT-D'S, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|12/04/2014|||OK30|ADDITIONAL INSPECTION STEP IN THE CAPACITOR ASSEMBLY EPOXY PROCESS FOR THE DEVICES.
P980016|S509|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|12/04/2014|||OK30|ADDITIONAL INSPECTION STEP IN THE CAPACITOR ASSEMBLY EPOXY PROCESS FOR THE DEVICES.
P090031|S003|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|MONOVISC|MOZ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|11/07/2014|02/04/2015|||APPR|APPROVAL TO EXPAND THE SPECIFICATION FOR RESIDUAL METHANOL INMONOVISC FROM <= 0.05% TO <= 0.03% W/W TO BE IN ACCORDANCE WITH RESIDUAL SOLVENT TESTING LIMITS UNDER USP GENERAL CHAPTER <467>, TO REVISE THE STABILITY TESTING PROTOCOL FOR MONOVISC, AND TO EXTEND THE SHELF LIFE OF MONOVISC FROM 2 YEARS TO 3 YEARS UTILIZING THIS REVISED STABILITY TESTINGPROTOCOL.
P100021|S042|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT IIS STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2014|11/25/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE SECONDARY AND TERTIARY PACKAGINGFOR ENDURANT IIS STENT GRAFT SYSTEMS, AS WELL AS A CHANGE IN CONFIGURATION FOR THE E-BEAM STERILIZATION PROCESS.
P060019|S030|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH ABLATION CATHETER|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2014|07/09/2015|||APPR|APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.
P930016|S044|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM|LZS|OP|Panel Track|Change Design/Components/Specifications/Material|N|11/10/2014|05/06/2015|15M-1707|07/15/2015|APPR|APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM. THIS DEVICE USES A 6.0 MM OPTICAL ZONE, AND 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) IN PATIENTS:1) WITH MYOPIA AS MEASURED BY THE IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM UP TO -11 D SPHERICAL EQUIVALENT WITH UP TO -5 D CYLINDER; AND2) WITH AGREEMENT BETWEEN MANIFEST REFRACTION (ADJUSTED FOR OPTICAL INFINITY) AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM REFRACTION AS FOLLOWS:1) SPHERICAL EQUIVALENT: MAGNITUDE OF THE DIFFERENCE IS LESS THAN 0.625 D; AND 2) CYLINDER: MAGNITUDE OF THE DIFFERENCE IS LESS THAN OR EQUAL TO 0.5 D; A) 18 YEARS OF AGE OR OLDER; AND B) WITH REFRACTIVE STABILITY (A CHANGE OF ¿ 1.0 D IN SPHERE OR CYLINDER FOR A MINIMUM OF 12 MONTHS PRIOR TO SURGERY).
P040014|S024|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETER|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2014|07/09/2015|||APPR|APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.
P040042|S029|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL ABLATION CATHETER, SAFIRE TX ABLATION CATHETER|OAD|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2014|07/09/2015|||APPR|APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.
P960016|S050|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2014|07/09/2015|||APPR|APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.
P110016|S014|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|SAFIRE DUO AND COOL PATH DUO ABLATION CATHETERS|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2014|07/09/2015|||APPR|APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.
P010033|S026|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB GOLD TEST|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/10/2014|||OK30|CHANGE TO THE MANUFACTURING PROCESS FOR BULK PEPTIDE SOLUTIONS.
P990071|S030|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|SMARTABLATE SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/12/2014|||OK30|CHANGE TO THE ASSEMBLER OF THE PRINTED CIRCUIT BOARD MODULES (PCB MODULES) THAT ARE USED IN THE SMARTABLATE SYSTEM.
P980041|S031|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/08/2014|||OK30|MODIFICATION TO THE QUALITY CONTROL STANDARD OPERATIONS PROCEDURES FOR AFP PREFILL AND POSTFILL REAGENT PACK.
P110013|S047|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/10/2014|||OK30|OPTION TO STERILIZE USING CYCLE #3 ON LINES 9 AND 3, CHANGING THE RESOLUTE INTEGRITY¿S PALLET CONFIGURATION, AND CO-STERILIZATION OF ALL SIMILAR DES DEVICES (INCLUDING THOSE COMMERCIALIZED OUTSIDE OF US).
P020016|S007|BIOMET MICROFIXATION, INC.|1520 TRADEPORT DR.||JACKSONVILLE|FL|32218||Joint, temporomandibular, implant|TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM|LZD|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/09/2014|||OK30|ELIMINATE A STEP WITHIN THE MANUFACTURING PROCESS.
P080026|S013|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HVB ASSAY|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/10/2014|||OK30|CHANGE TO THE EQUIPMENT UTILIZED FOR IDENTITY TESTING OF OLIGONUCLEOTIDES AT THE CONTRACT TESTING LABORATORY.
P100017|S011|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/10/2014|||OK30|CHANGE TO THE EQUIPMENT UTILIZED FOR IDENTITY TESTING OF OLIGONUCLEOTIDES AT THE CONTRACT TESTING LABORATORY.
P120012|S006|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|REALTIME HCV GENOTYPE II|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/10/2014|||OK30|CHANGE TO THE EQUIPMENT UTILIZED FOR IDENTITY TESTING OF OLIGONUCLEOTIDES AT THE CONTRACT TESTING LABORATORY.
P120010|S045|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ARTIFICIAL PANCREAS DEVICE SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2014|12/04/2014|||OK30|IMPLEMENTATION OF FIVE ADDITIONAL PIECES OF EQUIPMENT AT A CONTRACT MANUFACTURER TO SUPPORT THE MANUFACTURE OF THE LITHIUM POLYMER BATTERIES FOR THE MINILINKREAL-TIME TRANSMITTER MODEL NUMBER MMT-7703 AND THE IPRO2 DIGITAL RECORDER MODEL NUMBER MMT-7741. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL?] TIME SYSTEM, PARADIGM REAL?] TIME REVEL SYSTEM, GUARDIAN REAL?]TIME SYSTEM, MINILINKREAL?]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM. THE IPRO2 RECORDER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM.
P060033|S093|MEDTRONIC Inc.|3576 UNOCAL PLACE||SANTA ROSA|CA|95403|1774|Coronary drug-eluting stent|ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2014|12/10/2014|||OK30|OPTION TO STERILIZE USING CYCLE #3 ON LINES 9 AND 3, CHANGING THE RESOLUTE INTEGRITY¿S PALLET CONFIGURATION, AND CO-STERILIZATION OF ALL SIMILAR DES DEVICES (INCLUDING THOSE COMMERCIALIZED OUTSIDE OF US).
P840064|S058|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DUOVISC  AND DISCOVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2014|12/12/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE 1 ML SILICONE BARRELS.
P890047|S045|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2014|12/12/2014|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE 1 ML SILICONE BARRELS.
P040044|S059|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP VASCULAR CLOSURE DEVICES|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2014|08/03/2015|||APPR|APPROVAL FOR A NEW COEXTRUDED BALLOON SUBASSEMBLY OF THE MYNXGRIP VASCULAR CLOSURE DEVICE.
P970051|S124|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|COCHLEAR NUCLEUS C1512 IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2014|12/12/2014|||OK30|UPDATE A MISALIGNMENT BETWEEN INSPECTIONS CONDUCTED POST-TOP SHELL FILL MOLDING AND THE SILICONE FINISHING INSPECTION AT SUBSEQUENT OPERATIONS.
P810002|S091|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT MECHANICAL HEART VALVE, STANDARD AND MASTERS MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2014|12/15/2014|||OK30|IMPLEMENTATION OF NEW PROOF TESTER UNITS.
P130009|S016|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|NOVAFLEX DELIVERY SYSTEM|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|07/21/2015|||APPR|APPROVAL FOR IMPLEMENTATION OF THE USE OF A MODIFIED HYPOTUBEDURING THE SLOTTED SHAFT TO BALLOON CATHETER BONDING PROCESS FOR THE NOVAFLEX+ DELIVERY SYSTEM.
P960058|S113|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/12/2014|||OK30|RELOCATE THE ICS HYBRID SERIALIZATION PROCESS FROM THE HYBRID MANUFACTURER TO IN-HOUSE HYBRID SERIALIZATION PROCESS AT ADVANCED BIONICS.
P860003|S077|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2014|02/03/2015|||APPR|APPROVAL FOR A CHANGE IN THE POLYPROPYLENE MATERIAL USED FOR THEEFFLUENT TUBE OF THE CENTRIFUGE BOWLS IN THE UVAR XTS® PHOTOPHERESIS SYSTEM PROCEDURAL KITS.
P900056|S143|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2014|12/12/2014|||OK30|ADDITION OF AN ALTERNATE TEST METHOD FOR THE NON-DESTRUCTIVE PULL TENSILE TEST FOR THE ROTAWIRE COMPONENT.
P970051|S125|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS C1512 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2014|12/12/2014|||OK30|UPDATE THE ELECTRONIC ASSEMBLY INSPECTION STANDARD AND ALIGN THE ELECTRONIC ASSEMBLY INSPECTION STANDARD WITH THE CURRENT INSPECTION STANDARDS FOR THE NUCLEUS COCHLEAR IMPLANT SYSTEM.
P100022|S011|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/12/2014|01/13/2015|||APPR|APPROVAL TO THE POST-APPROVAL STUDY FOR THE DEVICE TO ALLOW FOR ENROLLMENT OF JAPANESE PMS PATIENTS WITH LESION LENGTH UP TO 200 MM PER LIMB IS COMPLETE.
P100029|S018|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice||N|11/13/2014|12/12/2014|||OK30|ALTERNATE BATCH SAMPLING/TESTING STRATEGY FOR BACTERIAL ENDOTOXIN TESTING (BET).
P030002|S032|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENS (IOLS)|MJP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/04/2014|||OK30|INSPECTION PROCEDURE CHANGES.
P100005|S005|ICAD, INC.|98 SPIT BROOK ROAD|SUITE 100|NASHUA|NH|03062||Analyzer,medical image|M-VU ALGORITHM ENGINE|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/2014|03/02/2015|||APPR|APPROVAL FOR M-VU ALGORITHM ENGINE VERSION 3.2.0.0.
P120008|S007|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/11/2014|||OK30|REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
P010030|S058|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/13/2014|02/22/2015|||APPR|APPROVAL FOR 1) ADDING A NEW SECTION TO THE PATIENT MANUAL THAT ADDRESSES `ENVIRONMENTAL CONSIDERATIONS RELATED TO NOISE AND VIBRATION; 2) ADDING A NEW SECTION TO THE OPERATOR MANUAL THAT ADDRESSES `PHYSICIAN INFORMATION TO INSTRUCT PATIENT CAREGIVERS; AND 3) ADDING A NEW SECTION TO THE PATIENT MANUAL THAT ADDRESSES `WHAT FAMILY MEMBERS NEED TO KNOW.
P980007|S037|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/11/2014|||OK30|REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
P110029|S018|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/11/2014|||OK30|REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
P910007|S046|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/11/2014|||OK30|REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
P980007|S038|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA (LN 6C07)|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/08/2014|||OK30|REPLACE AN EXISTING SUPPLIER WITH A NEW SUPPLIER FOR BOVINE SERUM ALBUMIN (BSA).
P970051|S126|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS CI522 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2014|06/15/2015|||APPR|APPROVAL FOR THE CI522 COCHLEAR IMPLANT.
P910007|S047|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA (LN 6CO6)|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/08/2014|||OK30|REPLACE AN EXISTING SUPPLIER WITH A NEW SUPPLIER FOR BOVINE SERUM ALBUMIN (BSA).
P110042|S043|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM S ICD SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/14/2014|03/13/2015|||APPR|APPROVAL FOR THE EMBLEM S-ICD SYSTEM.
P110004|S010|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR-CORONARY STENT ON RX SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/13/2014|05/14/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050042|S031|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/11/2014|||OK30|REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
P050051|S028|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/11/2014|||OK30|REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
P080023|S026|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/11/2014|||OK30|REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
P060035|S024|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2014|12/11/2014|||OK30|REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
P100047|S053|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/13/2014|06/09/2015|||APPR|APPROVAL FOR ALTERNATE BATTERY CELLS AND UPDATED SOFTWARE FOR THE HEARTWAREVENTRICULAR ASSIST DEVICE (HVAD) BATTERY PACK.
P950005|S055|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/08/2014|||OK30|ADDITIONAL SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P990025|S043|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/08/2014|||OK30|ADDITIONAL SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P120005|S030|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/12/2014|||OK30|MANUFACTURING CHANGE IN THE LAYER APPLICATION PROCESS FOR THE G4PLATINUM SENSOR, WHICH IS A COMPONENT OF THE DEXCOM G4¿ PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
P010068|S044|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS ELECTROPHYSIOLOGY CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/08/2014|||OK30|ADDITIONAL SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P110038|S008|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/12/2014|||OK30|ALTERNATE SUPPLIER FOR MEDICAL GRADE POLYVINYL CHLORIDE.
P030031|S064|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CELSIUS THERMOCOOL ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/08/2014|||OK30|ADDITIONAL SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P130009|S017|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|NOVAFLEX + DELIVERY SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/05/2014|||OK30|IMPLEMENT AN AUTOMATED DATA ANALYSIS SPREADSHEET USED DURING PRODUCT VERIFICATION TESTING.
P090003|S037|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|08/12/2015|||APPR|APPROVAL FOR REMOVAL OF THE STENT MASS IN-PROCESS MEASUREMENT AND AN ALTERNATE SAMPLING PLAN FOR THE WALL THICKNESS IN-PROCESS MEASUREMENT.
P060006|S064|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED SYSTEM|NIN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|08/12/2015|||APPR|APPROVAL FOR REMOVAL OF THE STENT MASS IN-PROCESS MEASUREMENT AND AN ALTERNATE SAMPLING PLAN FOR THE WALL THICKNESS IN-PROCESS MEASUREMENT.
P040016|S134|BOSTON SCIENTIFIC SCIMED, INC.|One Scimed Place||Maple Grove|MN|55311||STENT, CORONARY|VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|08/12/2015|||APPR|APPROVAL FOR REMOVAL OF THE STENT MASS IN-PROCESS MEASUREMENT AND AN ALTERNATE SAMPLING PLAN FOR THE WALL THICKNESS IN-PROCESS MEASUREMENT.
P110029|S019|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE AND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/17/2014|||OK30|SCALE UP THE MANUFACTURING BATCH SIZE FOR THE MICROPARTICLE CONCENTRATES.
P020002|S010|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|THINPREP IMAGING SYSTEM|MNM|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/14/2014|06/02/2015|||APPR|APPROVAL FOR USE OF THE THINPREP IMAGING SYSTEM WITH THE SLIDES PREPARED BY THE THINPREP 5000 SLIDE PROCESSOR.
P000014|S028|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/14/2014|12/11/2014|||OK30|REMOVAL OF AN UPPER TEST LIMIT SPECIFICATION OF A CURVE-SHAPE PARAMETER IN AN IN-PROCESS QUALITY CONTROL FUNCTIONALITY TEST.
P110013|S048|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|12/16/2014|||OK30|MODIFICATION TO THE TEST METHOD USED TO DETERMINE THE WATER CONTENT IN THE ZOTAROLIMUS DRUG.
P110023|S013|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|12/10/2014|||OK30|CHANGE IN THE RINSE SOLUTION FOR THE PRE-CLEAN BATH PRIOR TO ELECTROPOLISHING.
P080012|S024|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2014|02/12/2015|||APPR|APPROVAL FOR IMPLEMENTING A MIXED LOAD STERILIZATION CONFIGURATION FOR THE PROMETRA PUMPS ACCESSORY KITS, WHICH ARE ETHYLENE OXIDE STERILIZED.
P970003|S175|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY DEMIPULSE  AND VNS THERAPY DEMIPULSE DUO|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|12/17/2014|||OK30|IMPLEMENTATION OF A NEW ROUTING FIXTURE.
P910023|S349|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT ACCEL, CURRENT+ FAMILES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|12/15/2014|||OK30|ALTERNATE COMPONENT ATTACH MATERIAL FOR THE GMR COMPONENT ON HYBRID ASSEMBLIES FOR THE DEVICES.
P030054|S279|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE ACCEL, PROMOTE+ FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|12/15/2014|||OK30|ALTERNATE COMPONENT ATTACH MATERIAL FOR THE GMR COMPONENT ON HYBRID ASSEMBLIES FOR THE DEVICES.
P960043|S089|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE- MEDIATED CLOSURE SYSTEM, PERCLOSE A-T SUTURE-MEDIATED CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2014|01/20/2015|||APPR|APPROVAL FOR MODIFYING THE ANGLE TOLERANCE OF THE PLUNGER COMPONENT.
P100041|S061|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|11/25/2014|||OK30|EXPANSION OF THE CURRENT MANUFACTURING CLEAN ROOM ENVIRONMENT USED TO MANUFACTURE THE TRANSCATHETER HEART VALVE ACCESSORIES AT THE EDWARDS DRAPER, UTAH FACILITY.
P110021|S048|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|11/25/2014|||OK30|EXPANSION OF THE CURRENT MANUFACTURING CLEAN ROOM ENVIRONMENT USED TO MANUFACTURE THE TRANSCATHETER HEART VALVE ACCESSORIES AT THE EDWARDS DRAPER, UTAH FACILITY.
P130009|S018|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|11/25/2014|||OK30|EXPANSION OF THE CURRENT MANUFACTURING CLEAN ROOM ENVIRONMENT USED TO MANUFACTURE THE TRANSCATHETER HEART VALVE ACCESSORIES AT THE EDWARDS DRAPER, UTAH FACILITY.
P950029|S099|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY/ESPRIT PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2014|12/15/2014|||APPR|APPROVAL FOR A MODIFIED DESICCANT AND NEW BATTERY INSULATOR TO BE USED IN THE FINAL FINISHED DEVICES.
P970003|S174|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/17/2014|06/04/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P010021|S025|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|03/11/2015|||APPR|APPROVAL FOR CHANGES TO THE QC TESTING FOR THE RAW MATERIAL ANTI-HCV POSITIVE PLASMA.
P110037|S016|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQ/MAN CYTOMEGALOVIRUS TEST|PAB|MI|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2014|03/26/2015|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE TOTAL ASPIRATION AND DISPENSEMONITORING (TADM) TOLERANCE BAND PARAMETERS FOR THE COBAS P 630 INSTRUMENT FOR PIPETTING CAP/CTM CMV CONTROLS.
P960009|S211|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/17/2014|11/04/2015|||APPR|APPROVAL FOR 1) EXPANDED MRI CONDITIONS FOR MEDTRONIC DBS SYSTEMS; 2) UPDATES TO THE MODEL 37651 PATIENT RECHARGER SYSTEM;3) CLARIFICATIONS TO THE GUIDELINES FOR CONDUCTING CT SCANS ON DBS PATIENTS; 4) ADDITION OF SYMBOLS TO STERILE AND SHELF-BOX PACKAGE LABELS FOR SPECIFIED MODELS; AND (5) UPDATES TO PACKAGE CONFIGURATIONS FOR SPECIFIED MODELS.
P010032|S087|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ST. JUDE MEDICAL ADAPTER|LGW|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/18/2014|02/12/2015|||APPR|APPROVAL FOR MINOR LABELING CHANGES TO THE SJM 8-CHANNEL ADAPTOR (MODELS 2311 AND 2316); SPECIFICALLY, TO INCLUDE THE USE OF THE ADAPTOR WITH THE SJM TRIAL SYSTEM.
P030006|S027|MEDIFOCUS, INC|10240 OLD COLUMBIA ROAD|SUITE G|COLUMBIA|MD|21046||SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|PROLIEVE THERMODILATATION SYSTEM|MEQ|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2014|12/16/2014|||OK30|CHANGE TO REPLACE THE MANUAL PROCESS OF SANDING THE SURFACE PLATES OF THE HEAT EXCHANGER.
P910001|S074|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2014|12/16/2014|||OK30|REMOVE REPEATED STEPS FROM THE MANUFACTURING PROCESS.
P900009|S038|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN ULTRASOUND BONE HEALING SYSTEM|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2014|12/08/2014|||OK30|ADDITION OF A NEW SERVICING PROCESS.
P980044|S020|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2014|12/17/2014|||OK30|REPLACE A PREVIOUS AUTOCLAVE WITH A NEW AUTOCLAVE.
P980040|S054|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||TECNIS 1 PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM); TECNIS MULTIFOCAL 1 PIECE IOL WITH THE TECNIS ITEC P||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2014|12/17/2014|||OK30|ALTERNATE MOLDING SUPPLIER FOR THE LOWER BODY AND PROTECTOR CAP COMPONENTS OF THE TECNIS ITEC PRELOAD DELIVERY SYSTEM.
P120022|S002|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN EGFR RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/19/2014|||OK30|CHANGE TO THE MANUFACTURING METHOD OF THE POSITIVE CONTROL (PC) IN THE EGFR RGQ PCR KIT. THE CHANGE IN MANUFACTURING METHOD INCLUDES AN ADJUSTMENT STEP OF AN IN-PROCESS PROCEDURE TO ENSURE THAT TARGETED AMOUNTS OF EACH OLIGONUCLEOTIDE WITHIN THE PC ARE CALCULATED TO ACHIEVE THE TARGET CROSSING THRESHOLD (CT).
P100009|S008|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP DELIVERY SYSTEM|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/17/2014|||OK30|CHANGES RELATED TO THE LASER WELDING SUPPLIER AND ASSOCIATED INCOMING INSPECTIONS.
P980035|S401|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/12/2014|||OK30|MODIFICATIONS TO THE IN-PROCESS BATTERY INSPECTION REQUIREMENTS FOR THE BATTERIES USED IN THE  DEVICES.
P090013|S162|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/12/2014|||OK30|MODIFICATIONS TO THE IN-PROCESS BATTERY INSPECTION REQUIREMENTS FOR THE BATTERIES USED IN THE  DEVICES.
P890003|S325|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|PRODIGY IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/12/2014|||OK30|MODIFICATIONS TO THE IN-PROCESS BATTERY INSPECTION REQUIREMENTS FOR THE BATTERIES USED IN THE  DEVICES.
P020025|S065|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP TEMPERATURE ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/17/2014|||OK30|TRANSFER OF A DEVICE COMPONENT PRODUCTION SITE.
P980003|S055|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/17/2014|||OK30|TRANSFER OF A DEVICE COMPONENT PRODUCTION SITE.
P130021|S009|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE (R) SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/15/2014|||OK30|MODIFY THE ACCEPTANCE CRITERIA FOR THE PARAMETERS MEASURED BY THE FUNCTIONAL TESTER EQUIPMENT.
P980044|S021|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/17/2014|||OK30|UPDATE AND REPLACE A TESTING SYSTEM.
P980037|S044|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2014|05/14/2015|||APPR|APPROVAL OF AN ALTERNATE MOLDED COMPONENT VENDOR FOR THE ANGIOJET FAMILY OF THROMBECTOMY SETS.
P920047|S075|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2014|12/17/2014|||OK30|TRANSFER OF A DEVICE COMPONENT PRODUCTION SITE.
P100014|S017|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|SOLESTA INJECTABLE GEL|LNM|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|11/19/2014|01/21/2015|||APPR|APPROVAL FOR PATIENT LABELING CHANGES.
P100021|S043|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT, ENDURANT II, ENDURANT II AORTO -UNI-ILIAC (AUI) AND ENDURANT II'S STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2014|12/19/2014|||OK30|ADDITION OF NEW WIRE FORMING MACHINES TO THE STENT RING MANUFACTURING LINE.
P980044|S022|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice||N|11/20/2014|12/17/2014|||OK30|USE NEWLY INSTALLED EQUIPMENT.
P810006|S058|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2014|12/18/2014|||OK30|UPGRADE TO THE MICROFIB GRINDER BLADE FOR THE DEVICES.
P030011|S030|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2014|02/12/2015|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE FREEDOM DRIVER AC POWER SUPPLY.
P850010|S057|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2014|12/18/2014|||OK30|UPGRADE TO THE MICROFIB GRINDER BLADE FOR THE DEVICES.
P010032|S088|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON TM, EONC TM, PROTEGE, PROTEGE MRI AND BRIO IMPLANTABLE PULSE GENERATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2014|12/19/2014|||OK30|REPLACE THE AK-225 SOLVENT USED DURING THE MANUFACTURING PROCESS OF THE IMPLANTABLE PULSE GENERATORS.
P910077|S148|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Pacemaker/icd/crt non-implanted components|LATITUDE CONSULT SYSTEM|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2014|01/06/2015|||APPR|APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
P000018|S046|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|NOVOSTE BETA-CATH SYSTEM|MOU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/20/2014|10/06/2016|||APPR|Approval to extend the service life of the PCBA and PIB components located in the Transfer Device to 26 months.
P010012|S377|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|COGNIS, ENERGEN, PUNCTUA, INCEPTA,ORIGEN, INOGEN, DYNAGEN, AUTOGEN, (CRT-D RESYNCHRONIZATION DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2014|01/06/2015|||APPR|APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
P960040|S337|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2014|01/06/2015|||APPR|APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
P030005|S115|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE, INLIVEN, INTUA, VALITUDE, VALITUDE X4 (CRT-P RESYNCHRONIZATION DEVICES|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2014|01/06/2015|||APPR|APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
N970003|S169|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (PACEMAKER DEVICES)|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2014|01/06/2015|||APPR|APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
P120010|S046|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/10/2014|10/02/2015|15M-4013|11/02/2015|APPR|APPROVAL FOR THE MINIMED 530G SYSTEM WITH THRESHOLD SUSPEND FEATURING SMARTGUARD TECHNOLOGY. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE MINIMED 530G SYSTEM IS INTENDED FOR CONTINUOUS DELIVERY OF BASAL INSULIN (AT USER SELECTABLE RATES) AND ADMINISTRATION OF INSULIN BOLUSES (IN USER SELECTABLE AMOUNTS) FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS, SIXTEEN YEARS OF AGE AND OLDER, REQUIRING INSULIN AS WELL AS FOR THE CONTINUOUS MONITORING AND TRENDING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN. THE MINIMED 530G SYSTEM CAN BE PROGRAMMED TO AUTOMATICALLY SUSPEND DELIVERY OF INSULIN WHEN THE SENSOR GLUCOSE VALUE FALLS BELOW A PREDEFINED THRESHOLD VALUE. THE MINIMED 530G SYSTEM CONSISTS OF THE FOLLOWING DEVICES THAT CAN BE USED IN COMBINATION OR INDIVIDUALLY: MINIMED 530G INSULIN PUMP, ENLITE SENSOR, ENLITE SERTER, THE MINILINK REAL-TIME SYSTEM, THE BAYER CONTOUR NEXTLINK GLUCOSE METER, CARELINK PROFESSIONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES, AND CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES. THE SYSTEM REQUIRES A PRESCRIPTION.THE MINIMED 530G SYSTEM IS NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGER STICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON VALUES PROVIDED BY THE MINIMED 530G SYSTEM.  THE MINIMED 530G SYSTEM IS NOT INTENDED TO BE USED DIRECTLY FOR PREVENTING OR TREATING HYPOGLYCEMIA BUT TO SUSPEND INSULIN DELIVERY WHEN THE USER IS UNABLE TO RESPOND TO THETHRESHOLD SUSPEND ALARM TO TAKE MEASURES TO PREVENT OR TREAT  HYPOGLYCEMIA HIMSELF.  THERAPY TO PREVENT OR TREAT HYPOGLYCEMIA SHOULD BE ADMINISTERED ACCORDING TO THERECOMMENDATIONS OF THE USER¿S HEALTH CARE PROVIDER.
P950029|S100|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DE, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/16/2014|||OK30|ADDITION OF A C-MODE SCANNING ACOUSTIC  MICROSCOPY SYSTEM IN THE MANUFACTURING ASSEMBLY LINE.
P980049|S104|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750; RF DR 9750; RF VR 9750; RF DR 9750; INTENSIA VR ICD, INTENSIA DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/16/2014|||OK30|ADDITION OF A C-MODE SCANNING ACOUSTIC  MICROSCOPY SYSTEM IN THE MANUFACTURING ASSEMBLY LINE.
P060027|S071|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750; PARADYM RF CRT-D 9750; PARADYM RF BCRT-D9750; INTENSIA CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/16/2014|||OK30|ADDITION OF A C-MODE SCANNING ACOUSTIC  MICROSCOPY SYSTEM IN THE MANUFACTURING ASSEMBLY LINE.
P980044|S023|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/17/2014|||OK30|USE TWO NEWLY INSTALLED PIECES OF EQUIPMENT.
P100021|S044|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT, ENDURANT 11, ENDURANT IIS STENT GRAFT SYSTEM AND ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/19/2014|||APPR|APPROVAL FOR THE ADDITION OF A MANUFACTURING AID DURING THE HYDROPHILIC COATING PROCESS.
P030017|S209|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SYSTEM|LGW|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|11/21/2014|02/12/2015|||APPR|APPROVAL FOR MINOR LABELING CHANGES TO THE PRECISION SPECTRA¿ MRCONDITIONAL SPINAL CORD STIMULATION SYSTEM; SPECIFICALLY, THE ADDITION OF THE COVEREDGE 32 SURGICAL LEADS (SC-8336-50 AND SC-8352-50) TO THE SYSTEM.
P100023|S111|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/18/2014|||OK30|ADD ADDITIONAL LINES FOR THE MANUFACTURE OF THE STENT DELIVERY CATHETER OUTER COMPONENT AT THE GALWAY IRELAND MANUFACTURING FACILITY.
P110010|S100|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/18/2014|||OK30|ADD ADDITIONAL LINES FOR THE MANUFACTURE OF THE STENT DELIVERY CATHETER OUTER COMPONENT AT THE GALWAY IRELAND MANUFACTURING FACILITY.
P950039|S032|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSORS|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/10/2014|||OK30|MINOR MODIFICATION OF THE LIQUID CRYSTAL DISPLAY (LCD) CIRCUIT BOARD USED IN THE THINPREP 2000 PROCESSOR DISPLAY.
P010032|S089|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|TRIPOLE 16/16C,EXCLAIM,LAMITRODE 4/44/44C/88/S-4/S8, PENTA,OCTRODE, AND QUATTRODE LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/18/2014|||OK30|IMPLEMENT MANUFACTURING PROCESS CHANGES.
P810002|S092|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTERS MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/21/2014|12/18/2014|||OK30|ADDITION OF A NEW GRINDING MACHINE FOR REMOVAL OF EXCESS PYROLYTIC COATING.
P100046|S006|ATRICURE INC.|386 WEST MAIN STREET, SUITE 7||NORTHBOROUGH|MA|01532||Surgical cardiac ablation device, for treatment of atrial fibrillation|ATRICURE SYNERGY ABLATION SYSTEM|OCM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/21/2014|02/12/2015|||APPR|APPROVAL FOR UPDATING THE TRANSFORMER IN THE ASU GENERATOR.
P020014|S043|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|06/09/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAYER HEALTHCARE SRL IN  HEREDIA, COSTA RICA.
P830055|S153|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/18/2014|||OK30|IMPLEMENT ADDITIONAL DEVICE IDENTIFICATION MEASURES.
P000032|S042|CooperSurgical, Inc.|95 Corporate Dr.||Trumbull|CT|06611||DEVICE, THERMAL ABLATION, ENDOMETRIAL|HER OPTION CRYOABLATION  THERAPY SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/18/2014|||OK30|CHANGE TO THE QUALITY CONTROL HIGH POTENTIAL ELECTRICAL SAFETY ANALYZER FROM ONE DEVICE TO ANOTHER.
P130024|S001|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX DRUG COATED BALLOON (DCB)|ONU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2014|01/22/2015|||APPR|APPROVAL FOR A CHANGE IN BALLOON PROTECTOR FROM A SLIDE-OFF TO A PEELAWAY DESIGN.
P100009|S009|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/22/2014|||OK30|IMPLEMENTATION OF AN ADDITIONAL ETHYLENE OXIDE STERILIZATION CHAMBER AT THE CURRENT STERILIZATION FACILITY.
P030017|S210|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR(SCS) SYSTEM AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/2014|02/13/2015|||APPR|APPROVAL FOR THE PRECISIO S8 ADAPTER THAT WILL BE USED TO CONNECT THE PRECISION IMPLANTABLE PULSE GENERATOR (IPG) OR THE PRECISION SPECTRA IPG TO THE FOLLOWING ST. JUDE MEDICAL (SJM) SCS LEADS:  3283/3286/3268/3269 LAMITRODE S8, 3280 LAMITRODE 8, 3244/3262/3263 LAMITRODE 44, 3245/3264/3265 LAMITRODE 44C, 3208 LAMITRODE TRIPOLE 8, 3210LAMITRODE TRIPOLE 8C, 3288 LAMITRODE 88, 3289 LAMITRODE 88C, 3214 LAMITRODE TRIPOLE 16C, 3219 LAMITRODE TRIPOLE 16, 3228 PENTA, 3183/3186/3189/3191 OCTRODE, 3086 OCTRODE TRIAL LEAD KIT, 2283 8-CHANNEL ADAPTER,  3341/3342/ 3343/3346 DUAL 4 EXTENSION, 3382/3383/3386SINGLE 8 EXTENSION.
P010012|S379|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/19/2014|||OK30|CHANGES TO THE CRYSTAL OSCILLATOR COMPONENT MANUFACTURING PROCESS AT THE CURRENT SUPPLIER.
P960040|S338|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/19/2014|||OK30|CHANGES TO THE CRYSTAL OSCILLATOR COMPONENT MANUFACTURING PROCESS AT THE CURRENT SUPPLIER.
P980044|S024|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/2014|03/31/2015|||APPR|APPROVAL FOR REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND THE PATIENT INFORMATION (PI) FOR SUPARTZ AS FOLLOWS:1) REVISION IN THE IFU AND PI OF THE STATEMENT, ¿THE SAFETY AND EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF SUPARTZ HAVE NOT BEEN ESTABLISHED.¿ TO ¿THE EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF SUPARTZ HAS NOT BEEN ESTABLISHED.¿; AND  2) INSERTION IN THE IFU AND PI OF THE STATEMENTS, ¿ADVERSE EXPERIENCE DATA FROM THE LITERATURE CONTAIN NO EVIDENCE OF INCREASED SAFETY RISK RELATING TO RETREATMENT WITH SUPARTZ. THE FREQUENCY AND SEVERITY OF ADVERSE EVENTS OCCURRING DURING REPEAT TREATMENT CYCLES DID NOT INCREASE OVER THAT REPORTED FOR A SINGLE TREATMENT CYCLE.¿
P050047|S043|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/24/2014|12/05/2014|||APPR|APPROVAL FOR STRENGTHENING THE CURRENT WARNING AND DISCUSSING THE POTENTIAL ADVERSE REACTION(S) ASSOCIATED WITH INTRAVASCULAR INJECTION.
P010012|S378|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/12/2014|||OK30|MODIFY THE CRYSTAL OSCILLATOR MANUFACTURING PROCESS AT AN EXISTING SUPPLIER FOR THE DEVICES.
P010031|S474|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II,CONSULTA,MAXIMO II,PROTECTA AND PROTECTA XT CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/12/2014|||OK30|UPDATE TO THE PRE-PULSE OPEN CIRCUIT TEST LIMITS.
P980016|S510|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II,PROTECTA,PROTECTA XT,SECURA AND VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/12/2014|||OK30|UPDATE TO THE PRE-PULSE OPEN CIRCUIT TEST LIMITS.
P960040|S339|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/12/2014|||OK30|MODIFY THE CRYSTAL OSCILLATOR MANUFACTURING PROCESS AT AN EXISTING SUPPLIER FOR THE DEVICES.
P840001|S286|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/22/2014|||OK30|CHANGE THE SAMPLING STRATEGY FOR THE SPECIAL MANUFACTURING PROCESS MONITORING.
P960009|S212|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/22/2014|||OK30|CHANGE THE SAMPLING STRATEGY FOR THE SPECIAL MANUFACTURING PROCESS MONITORING.
P970004|S186|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM  THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/22/2014|||OK30|CHANGE THE SAMPLING STRATEGY FOR THE SPECIAL MANUFACTURING PROCESS MONITORING.
P080025|S082|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2014|12/22/2014|||OK30|CHANGE THE SAMPLING STRATEGY FOR THE SPECIAL MANUFACTURING PROCESS MONITORING.
P960004|S067|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROID-ELUTING PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2014|12/11/2014|||OK30|MODIFY THE HIPOT TEST SPECIFICATIONS CONDUCTED DURING THE BRADY LEADS MANUFACTURING.
P010054|S024|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS CALCHECK|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2014|12/22/2014|||OK30|RELOCATION OF THE FINAL KIT ASSEMBLY AND LABELING OPERATIONS TO A NEW BUILDING WITHIN THE SAME FACILITY.
P000027|S020|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA CALCHECK|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2014|12/22/2014|||OK30|RELOCATION OF THE FINAL KIT ASSEMBLY AND LABELING OPERATIONS TO A NEW BUILDING WITHIN THE SAME FACILITY.
P990012|S022|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG CONFIRMATORY TEST|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2014|12/22/2014|||OK30|RELOCATION OF THE FINAL KIT ASSEMBLY AND LABELING OPERATIONS TO A NEW BUILDING WITHIN THE SAME FACILITY.
P040043|S070|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2014|12/17/2014|||OK30|CHANGE TO AN IN-PROCESS INSPECTION STEP OF THE GORE TAG THORACIC ENDOPROSTHESIS MANUFACTURING PROCESS.
P990075|S030|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2014|12/15/2014|||OK30|CHANGE TO AUTOMATE THE EXISTING SILICONE ELASTOMER SHEET CUTTER USED TO CUT PART COMPONENTS FOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS, MENTOR MEMORYGELSILICONE GEL-FILLED BREAST IMPLANTS AND MENTOR MEMORYSHAPE BREAST IMPLANTS MANUFACTURED ATMENTOR'S IRVING, TEXAS FACILITY.
P030053|S021|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2014|12/15/2014|||OK30|CHANGE TO AUTOMATE THE EXISTING SILICONE ELASTOMER SHEET CUTTER USED TO CUT PART COMPONENTS FOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS, MENTOR MEMORYGELSILICONE GEL-FILLED BREAST IMPLANTS AND MENTOR MEMORYSHAPE BREAST IMPLANTS MANUFACTURED ATMENTOR'S IRVING, TEXAS FACILITY.
P060028|S003|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2014|12/15/2014|||OK30|CHANGE TO AUTOMATE THE EXISTING SILICONE ELASTOMER SHEET CUTTER USED TO CUT PART COMPONENTS FOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS, MENTOR MEMORYGELSILICONE GEL-FILLED BREAST IMPLANTS AND MENTOR MEMORYSHAPE BREAST IMPLANTS MANUFACTURED ATMENTOR'S IRVING, TEXAS FACILITY.
P120005|S031|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Panel Track|Change Design/Components/Specifications/Material|N|11/26/2014|05/22/2015|15M-1959|06/11/2015|APPR|APPROVAL FOR THE DEXCOM G4¿ PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS DEVICE IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES 2 TO 17 YEARS WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P980022|S173|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP AND PARADIGM REAL TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2014|12/19/2014|||OK30|REPROGRAMMING OF NEW PC BOARDS/ STACKS FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), AND MINIMED 530GINSULIN PUMP (MODELS: MMT-551, MMT-751) IN MEDTRONIC PUERTO RICO OPERATIONS CO.(MPROC). THE PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULINPUMP, AND MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM, RESPECTIVELY.
P120010|S047|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2014|12/19/2014|||OK30|REPROGRAMMING OF NEW PC BOARDS/ STACKS FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), AND MINIMED 530GINSULIN PUMP (MODELS: MMT-551, MMT-751) IN MEDTRONIC PUERTO RICO OPERATIONS CO.(MPROC). THE PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULINPUMP, AND MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM, RESPECTIVELY.
P080029|S002|INTERVENTIONAL THERAPIES, LLC.|1 GORHAM ISLAND||WESTPORT|CT|06880||Device, hemostasis, vascular|QUICK-CLOSE VASCULAR SUTURING SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2014|12/18/2014|||OK30|CHANGE TO THE DIMENSIONAL TOLERANCES OF THE CANNULA AND MODIFICATIONS TO THE BONDING PROCESS FOR TWO DEVICE SUBASSEMBLIES.
P100045|S002|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM|MOM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/26/2014|07/10/2015|||APPR|APPROVAL FOR THE NEXT GENERATION OF HOME USE ELECTRONICS, THE I3 PATIENT ELECTRONICS.
P100026|S025|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2014|12/22/2014|||OK30|UPDATE THE EQUIPMENT SOFTWARE.
P120006|S018|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/26/2014|12/18/2014|||OK30|MODIFICATIONS TO THE EQUIPMENT FOR STENT GRAFT LOADING.
P080011|S033|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2014|01/21/2015|||OK30|ADD A NEW MANUFACTURING LINE FOR BIOFINITY (COMFILCON A) EXTENDED-WEARCONTACT LENSES AT THE COOPERVISION, HAMBLE FACILITY, UNITED KINGDOM.
P090015|S002|Leica Biosystems|36 Cherry Hill Drive||Danvers|MA|01923||SYSTEM, TEST, HER-2/NEU, IHC|BOND ORACLE HER2 IHC SYSTEM|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2014|02/13/2015|||APPR|APPROVAL FOR INTRODUCTION OF BOND VERSION 5.1 SOFTWARE FOR USE ONTHE BOND ORACLE HER2 IHC SYSTEM.
P010012|S380|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/28/2014|01/21/2015|||APPR|APPROVAL FOR AN ADDITION OF SILGLIDE COATING TO THE OUTER DISTAL SILICONE BODY TUBING TO EASE DELIVERY THROUGH AN INNER CATHETER 7 FRENCH AND ASSOCIATED LABEL CHANGES TO REBRAND THE LEAD AS EASYTRAK 2+.
P090016|S013|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2014|05/24/2016|||APPR|Sharing equipment used during the manufacture of belotero balace dermal filler across other product lines.
P930038|S074|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2014|06/16/2015|||APPR|CHANGE TO THE INSPECTION METHOD FOR PACKAGE TEMPERATURE INDICATORS.
P010052|S012|Siemens Healthcare Diagnostics Products, LTD|GLYN RHONWY||LLANBERIS, CAERNARFON||LL55||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2014|07/27/2015|||APPR|APPROVAL TO CHANGE THE MANUFACTURING PROCESS FOR THE CONJUGATE BULK SOLUTION.
P040027|S039|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/28/2014|01/06/2015|||OK30|ALTERNATE RESIN FOR MANUFACTURE OF THE BASE TUBE COMPONENTS.
P050034|S015|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|VISIONCARE IMPLANTABLE MINIATURE TELESCOPE|NCJ|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/28/2014|01/27/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY PROTOCOL: UPDATED STUDY PROTOCOL WITH THE INCLUSION OF CASE REPORT FORM (CRF) AND STUDY TIMELINE.
P120010|S048|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2014|12/31/2014|||OK30|ADDITION OF THE MEDTRONIC JUNCOS LAB AS A SITE FOR ENDOTOXIN TESTING FOR THEENLITE SENSOR THAT IS PART OF THE MINIMED 530G SYSTEM.
P100024|S006|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2014|12/29/2014|||OK30|MODIFICATION OF THE QUALITY CONTROL FOR INCOMING ALU-PNAS MATERIALS TOREDUCE HIGH BACKGROUND SIGNAL IN THE NEGATIVE CONTROLS.
P130009|S019|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2014|12/15/2014|||OK30|CHANGE TO THE INK HARDENER USED IN THE PAD PRINTING OF GRAPHICS ONTO THE NOVAFLEX+ DELIVERY  SYSTEM AND THE EDWARDS EXPANDABLE INTRODUCER SHEATH SET.
P980040|S055|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||TECNIS 1-PIECE IOL, MODEL:ZCB00,TECNIS MULTIFOCAL 1-PIECE IOL, MODEL:ZMB00,TECNIS TORIC 1-PIECE IOL,MODELS:ZCT150, ZCT22||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2014|12/31/2014|||OK30|ALTERNATE SUPPLIER FOR AN INTRAOCULAR PACKAGING COMPONENT.
P060039|S065|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/03/2014|03/11/2015|||APPR|APPROVAL AN UPDATE TO THE MANUFACTURING PROCESS OF THE BLUE TUBING USED IN THE CONSTRUCTION OF THE LEAD TO REPLACE TYGON WITH VITON.
P110029|S020|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY PMA ASSAYS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2014|12/30/2014|||OK30|CHANGE TO DISCONTINUE REDUNDANT IN-PROCESS QC TESTS FOR PURIFIED ANTIBODIES AND ANTIGENS.
P050051|S029|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB PMA ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2014|12/30/2014|||OK30|CHANGE TO DISCONTINUE REDUNDANT IN-PROCESS QC TESTS FOR PURIFIED ANTIBODIES AND ANTIGENS.
P100047|S054|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2014|12/19/2014|||OK30|ADD AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE HEARTWARE VENTRICULAR ASSIST SYSTEM PUMP.
P980035|S402|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2014|12/23/2014|||OK30|NEW FINAL FUNCTIONAL TESTER FOR FINAL DEVICE ASSEMBLY MANUFACTURING FACILITIES.
P060037|S033|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2014|12/30/2014|||OK30|CHANGE IN THE CLEANING PROCESS.
P980022|S174|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2014|01/02/2015|||OK30|IMPLEMENTATION OF A NEW TOOL USED AT A CONTRACT MANUFACTURER TO SUPPORT THE BACK END TESTING OF THE ASSEMBLED MINILINK REAL-TIME TRANSMITTER (MMT-7703). THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL?]TIME SYSTEM, PARADIGMREAL?]TIME REVEL SYSTEM, GUARDIAN REAL?]TIME SYSTEM, MINILINK REAL?]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM.
P120010|S049|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM AND MINILINK REAL-TIME SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2014|01/02/2015|||OK30|IMPLEMENTATION OF A NEW TOOL USED AT A CONTRACT MANUFACTURER TO SUPPORT THE BACK END TESTING OF THE ASSEMBLED MINILINK REAL-TIME TRANSMITTER (MMT-7703). THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL?]TIME SYSTEM, PARADIGMREAL?]TIME REVEL SYSTEM, GUARDIAN REAL?]TIME SYSTEM, MINILINK REAL?]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM.
P980035|S403|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2014|12/19/2014|||OK30|NEW SUPPLIER FOR GOLD PREFORM COMPONENTS THAT ARE USED AS BRAZING PREFORMS IN THE MANUFACTURING OF FEEDTHROUGHS FOR THE  DEVICES.
P010031|S475|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2014|12/19/2014|||OK30|NEW SUPPLIER FOR GOLD PREFORM COMPONENTS THAT ARE USED AS BRAZING PREFORMS IN THE MANUFACTURING OF FEEDTHROUGHS FOR THE  DEVICES.
P980016|S511|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA IC|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2014|12/19/2014|||OK30|NEW SUPPLIER FOR GOLD PREFORM COMPONENTS THAT ARE USED AS BRAZING PREFORMS IN THE MANUFACTURING OF FEEDTHROUGHS FOR THE  DEVICES.
P010015|S254|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2014|12/19/2014|||OK30|NEW SUPPLIER FOR GOLD PREFORM COMPONENTS THAT ARE USED AS BRAZING PREFORMS IN THE MANUFACTURING OF FEEDTHROUGHS FOR THE  DEVICES.
P090013|S163|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/05/2014|12/19/2014|||OK30|NEW SUPPLIER FOR GOLD PREFORM COMPONENTS THAT ARE USED AS BRAZING PREFORMS IN THE MANUFACTURING OF FEEDTHROUGHS FOR THE  DEVICES.
P020056|S031|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE INSPIRA BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/05/2014|06/03/2015|||APPR|APPROVAL FOR A LINE EXTENSION IDENTIFIED AS THE NATRELLE INSPIRA SILICONE-FILLED BREAST IMPLANTS TO ADD BREAST IMPLANT OPTIONS TO THE NATRELLE SILICONE-FILLED BREAST IMPLANTS.
P910001|S075|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|01/07/2015|||OK30|CHANGE TO YOUR DISTAL JACKET FUSE PROCESS.
P100023|S112|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|01/14/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN MAPLE GROVE, MINNESOTA.
P110010|S101|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM,PROMUS PREMIER EVEROLIMUS-ELUTING PLATINU|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|01/14/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN MAPLE GROVE, MINNESOTA.
P130030|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|01/14/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN MAPLE GROVE, MINNESOTA.
P930039|S122|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD AND VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|01/06/2015|||OK30|UPDATES TO THE PARAMETERS OF THE PLASMA TREATMENT PROCESS USED FOR THE SILICONE TUBING COMPONENT.
P060022|S020|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2014|02/03/2015|||APPR|APPROVAL TO MODIFY THE LABELING TO INCLUDE THE BAUSCH + LOMB IOLINJECTOR (MODEL VIS100) TO THE VALIDATED INSERTERS LIST ON THE LABELING OF THE AKREOS AO60 INTRAOCULAR LENS (IOL).
P060028|S004|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|12/16/2014|||OK30|CHANGE TO AUTOMATE THE MANUAL SECONDARY PACKAGING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IM LANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P030053|S022|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|12/16/2014|||OK30|CHANGE TO AUTOMATE THE MANUAL SECONDARY PACKAGING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IM LANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P990075|S031|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|12/16/2014|||OK30|CHANGE TO AUTOMATE THE MANUAL SECONDARY PACKAGING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IM LANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P010031|S476|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D AND VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|12/19/2014|||OK30|NEW REWORK MANUFACTURING PROCESS FOR THE BONDED ANODE SUBASSEMBLY USED IN THE CAPACITORS FOR THE DEVICES.
P980016|S512|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|12/19/2014|||OK30|NEW REWORK MANUFACTURING PROCESS FOR THE BONDED ANODE SUBASSEMBLY USED IN THE CAPACITORS FOR THE DEVICES.
P100010|S046|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER|OAE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/2014|02/27/2015|||APPR|APPROVAL FOR TWO NEW MODELS TO BE ADDED TO THE ARCTIC FRONT FAMILY OF CARDIAC CRYOABLATION CATHETERS: ARCTIC FRONT ADVANCE ST CARDIAC CRYOABLATION CATHETERS MODELS 2AFAST23 AND 2AFAST28.
P910023|S351|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FORTIFY VR,FORTIFY DR,FORTIFY ASSURA VR, FORTIFY ASSURA DR ICDS|LWS|CV|Real-Time Process||N|12/08/2014|01/28/2015|||APPR|APPROVAL FOR MODIFIED DESIGN OF INSULATING TAPE.
P030054|S280|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA CRT-DS|NIK|CV|Real-Time Process||N|12/08/2014|01/28/2015|||APPR|APPROVAL FOR MODIFIED DESIGN OF INSULATING TAPE.
P110002|S008|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|12/29/2014|||OK30|ADDITION OF A MANUFACTURING MACHINE AND A CLEANING PROCESS EQUIPMENT CHANGE.
P110009|S008|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|12/29/2014|||OK30|ADDITION OF A MANUFACTURING MACHINE AND A CLEANING PROCESS EQUIPMENT CHANGE.
P110002|S009|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2014|02/05/2015|||APPR|APPROVAL FOR MODIFICATIONS MADE TO THE MOBI-C UNIVERSAL INSERTERINSTRUMENT, WHICH INCLUDED ADDITION OF MATERIAL TO INCREASE THE INNER DIAMETER AND A CHANGE TO THE LASER MARKING AND PASSIVATION PROCESS.
P110009|S009|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2014|02/05/2015|||APPR|APPROVAL FOR MODIFICATIONS MADE TO THE MOBI-C UNIVERSAL INSERTERINSTRUMENT, WHICH INCLUDED ADDITION OF MATERIAL TO INCREASE THE INNER DIAMETER AND A CHANGE TO THE LASER MARKING AND PASSIVATION PROCESS.
P910001|S076|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS EXCIMER CORONARY LASER ATHERECTOMY (ELCA) CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|01/08/2015|||OK30|CHANGE TO AUTOMATE THE PIN CUTTING PROCESS ON THE PROXIMAL HANDLE WHICH IS CURRENTLY PERFORMED MANUALLY.
P960042|S051|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATHS (SLS)|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|01/08/2015|||OK30|CHANGE TO AUTOMATE THE PIN CUTTING PROCESS ON THE PROXIMAL HANDLE WHICH IS CURRENTLY PERFORMED MANUALLY.
P930039|S123|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS, LEAD AND CAPSUREFIX , NOVUS MRI SURESCAN AND VITATRON CRYSTALLINE LEADS|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/2014|03/18/2016|||APPR|Approval for a design change to the lead helix electrode and a manufacturing site change and the related update to analytical methods and tightened specifications proposed for drug related elements of the medical devices.
P090013|S164|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURE AND SCAN LEAD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/2014|03/18/2016|||APPR|Approval for a design change to the lead helix electrode and a manufacturing site change and the related update to analytical methods and tightened specifications proposed for drug related elements of the medical devices.
P000006|S039|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2014|01/07/2015|||OK30|IMPLEMENTING USE OF AN ADDITIONAL PIECE OF EQUIPMENT.
P970003|S176|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105|MUZ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/09/2014|03/04/2015|||APPR|APPROVAL FOR AN UPDATE TO THE LONGEVITY MANUFACTURING REQUIREMENTASSOCIATED WITH THE MODEL 102/102R AND MODEL 105 GENERATORS.
P130021|S010|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE SYSTEM|NPT|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/09/2014|03/30/2015|15M-1064|04/03/2015|APPR|APPROVAL FOR THE MEDTRONIC COREVALVE SYSTEM. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO EITHER SEVERE NATIVE CALCIFIC AORTIC STENOSIS OR FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC VALVE WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >=8% OR AT A >=15% RISK OF MORTALITY AT 30 DAYS).
P950029|S101|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR/ ESPRIT SR,  REPLY DR/ ESPRIT DR FAMILY OF PACEMAKERS|NVZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2014|12/23/2014|||APPR|APPROVAL FOR OPTIMIZATION OF THE GLUING PROCESS FOR THE SILICONE CAPS.
P120010|S050|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2014|01/07/2015|||OK30|INCREASE TO THE LASER CUTTING SPEED OF THE RESONETICS GALVO LASER SYSTEM USED IN THE SENSOR FABRICATION PROCESS FOR THE ENLITE SENSOR. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P030031|S065|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATIONAL CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/10/2014|03/18/2015|||APPR|APPROVAL FOR MODIFICATION OF THE THERMOCOOL SMARTTOUCH SHAFT AND SENSOR.
P040036|S048|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATIONAL CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/10/2014|03/18/2015|||APPR|APPROVAL FOR MODIFICATION OF THE THERMOCOOL SMARTTOUCH SHAFT AND SENSOR.
P120009|S002|PFM MEDICAL, INC|1815 ASTON AVE|SUITE 106|CARLSBAD|CA|92008||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|NIT-OCCLUD SYSTEM|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2014|01/21/2015|||OK30|ADDITION OF A NEW PIECE OF EQUIPMENT FOR A MANUFACTURING PROCESS INVOLVING COILING OF WIRE.
P000025|S081|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|MED-EL COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/11/2014|03/11/2015|||APPR|APPROVAL FOR THE DL-COIL, AN EXTERNAL AUDIO PROCESSOR COIL FOR USE WITH THE MED-EL COCHLEAR IMPLANT, AS PART OF THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.
P040044|S060|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX ACE VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2014|01/09/2015|||OK30|IMPLEMENT A REWORK STEP TO RELOAD THE HYDROGEL IN THE MYNX ACE DEVICE (MODEL MX6740).
P840001|S287|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS|LGW|NE|30-Day Notice||N|12/16/2014|01/16/2015|||OK30|ADD TWO ADDITIONAL DEVICE MODELS TO A PREVIOUS CHANGE IN NEW MATERIAL ON THE INTEGRATED CIRCUIT COMPONENTS USED IN THE DEVICE.
P120016|S008|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2014|01/09/2015|||OK30|ADDITION OF A POUCH SEALER AND ASSOCIATED PROCESSES TO FACILITATE PACKAGING.
P130005|S004|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2014|05/14/2015|||APPR|APPROVAL FOR A CHANGE TO THE SEALING PROCESS FOR THE NOSECONE-TO-GLUE PLUG AND GLUE PLUG-TO-SALINE SHEATH BONDS TO USE LIGHT WITHIN A NARROWER ULTRAVIOLET (UV) WAVELENGTH FOR CURING THE SEALING ADHESIVE.
P110011|S008|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2014|01/06/2015|||OK30|CHANGE TO THE ROUTINE STERILIZATION DOSE AUDITS.
P040044|S061|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/12/2014|01/09/2015|||OK30|IMPLEMENT A 12-TRAY COLD PLATE SYSTEM FOR HYDROGEL MANUFACTURING.
P960040|S340|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|01/09/2015|||OK30|ADDITIONAL SUPPLIER FOR THE POWER INDUCTORS USED IN THE DEVICES.
P010012|S381|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|01/09/2015|||OK30|ADDITIONAL SUPPLIER FOR THE POWER INDUCTORS USED IN THE DEVICES.
P010032|S090|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2014|03/04/2015|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE STYLET MODELS THAT ARE USED WITHSJM SCS SYSTEMS; SPECIFICALLY, COATING THE STYLETS WITH A PFOA-FREE PTFE, RESULTING IN GENERATION 3 OF THE STYLETS. THIS SUPPLEMENT ALSO REQUESTED APPROVAL FOR A MANUFACTURING CHANGE TO TIGHTEN THE TOLERANCES ON THE TOOLING MANDREL USED TO MANUFACTURE THE ASSOCIATED LEAD MODELS.
P080011|S034|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|01/22/2015|||OK30|CHANGE TO THE FREQUENCY OF WATER CONTENT TESTING FOR THE COMFILCON A SOFT, EXTENDED-WEAR CONTACT LENSES.
P980022|S175|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSLIN  PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|01/14/2015|||OK30|A CHANGE IN TERTIARY SUPPLIERS AND METHOD FOR THE NICKEL AND GOLD PLATING PROCESS FOR THE KEYPAD FLEXIBLE CIRCUIT FOR THE PARADIGM REAL-TIME INSULIN PUMP (MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MMT-523,MMT-523K, MMT-723, MMT-723K) AND MINIMED 530G INSULIN PUMP (MMT-551, MMT-751) THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM, THE PARADIGM REAL-TIME REVEL SYSTEM AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
P120010|S051|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINI-MED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|01/14/2015|||OK30|A CHANGE IN TERTIARY SUPPLIERS AND METHOD FOR THE NICKEL AND GOLD PLATING PROCESS FOR THE KEYPAD FLEXIBLE CIRCUIT FOR THE PARADIGM REAL-TIME INSULIN PUMP (MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MMT-523,MMT-523K, MMT-723, MMT-723K) AND MINIMED 530G INSULIN PUMP (MMT-551, MMT-751) THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM, THE PARADIGM REAL-TIME REVEL SYSTEM AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
P010032|S091|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|09/25/2015|||APPR|Approval for a manufacturing site located at St. Jude Medical Puerto Rico LLC, Lot. A Interior  #2 Street, Km. 67.5 Santana Industrial Park, Arecibo, PR
P120022|S004|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN EGFR RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|01/15/2015|||OK30|RELOCATION OF THE QUALITY CONTROL LABORATORIES WITHIN QIAGEN MANCHESTER LTD. SKELETON HOUSE FACILITY.
P110027|S002|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN KRAS RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|01/15/2015|||OK30|RELOCATION OF THE QUALITY CONTROL LABORATORIES WITHIN QIAGEN MANCHESTER LTD. SKELETON HOUSE FACILITY.
P030053|S023|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2014|01/13/2015|||OK30|CHANGE TO PROVIDE FOR A NEW GEL FILL PUMP SYSTEM USED IN THE MANUFACTURE OF MENTOR MEMORYGEL BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.
P080011|S035|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2014|03/11/2015|||APPR|APPROVAL FOR A CHANGE IN TRADE NAME FOR THE BIOFINITY ENERGYS ASPHERIC LENS AND EXPANDED POWERS FOR THE BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL LENSES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, AND BIOFINITY XR MULTIFOCAL (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOREXTENDED WEAR AND ARE INDICATED FOR:  BIOFINITY ENERGYS ASPHERE (COMFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.BIOFINITY XR TORIC (COMFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA OR HYPEROPIA WITH ASTIGMATISM) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 D AND ASTIGMATISM CORRECTIONS FROM -0.25 TO -5.75 D.BIOFINITY XR MULTIFOCAL (COMFILCON A) LENSES ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) WITH EMMETROPIA WITH PRESBYOPIA IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 D AND WITH ADD POWERS FROM +0.05 TO +4.00 D. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBITASTIGMATISM OF 2.00 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.
P930014|S076|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF ASPHERIC UV ABSORBING INTRAOCULAR LENSES (IOLS)|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2014|03/10/2015|||APPR|APPROVAL FOR THE ACRYSOF® ASPHERIC UV ABSORBING INTRAOCULAR LENS (IOL) MODEL SA60WF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF® ASPHERIC UV ABSORBING INTRAOCULAR LENSES (IOLS) AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. THIS LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
P090022|S024|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2014|01/15/2015|||OK30|NOTIFICATION OF AN ADDITIONAL ROTLEX IOLA PLUS LENS ANALYZER USED DURING THE MANUFACTURING PROCESS.
P900056|S144|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2014|05/12/2015|||APPR|APPROVAL TO UPDATE INSPECTION REQUIREMENTS AT THE BSC CORK, IRELAND SITE.
P960040|S341|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2014|01/06/2015|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE TRANSFORMER USED IN THE HIGH VOLTAGE CIRCUIT IN THE DEVICES.
P010012|S382|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||DYNAGEN, INOGEN, ORIGEN CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2014|01/06/2015|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE TRANSFORMER USED IN THE HIGH VOLTAGE CIRCUIT IN THE DEVICES.
P040045|S048|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2014|01/16/2015|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR THE SENOFILCON AMONOMER USED FOR MANUFACTURING OF VISTAKON® (SENOFILCON A) BRAND CONTACT LENSES.
P960016|S051|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2014|02/02/2015|||APPR|APPROVAL FOR A CHANGE TO THE BUCKLE FORCE PRODUCT REQUIREMENT FOR THELIVEWIRE TC AND SAFIRE BI-DIRECTIONAL ABLATION CATHETERS.
P020025|S066|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2014|01/15/2015|||OK30|ACCEPTANCE OF MANUFACTURING CHANGES CONSISTING OF A NEW FIXTURE AND IN-PROCESS TESTING EQUIPMENT FOR THE INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS.
P910023|S352|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2014|02/25/2015|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 20.0.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM (PCS) PROGRAMMER.
P030054|S281|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2014|02/25/2015|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 20.0.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM (PCS) PROGRAMMER.
P030035|S131|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-P'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2014|02/25/2015|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 20.0.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM (PCS) PROGRAMMER.
P970013|S063|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKER|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2014|02/25/2015|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 20.0.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM (PCS) PROGRAMMER.
P880086|S253|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY /INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2014|02/25/2015|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 20.0.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM (PCS) PROGRAMMER.
P880006|S092|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SESOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2014|02/25/2015|||APPR|APPROVAL FOR THE MODEL 3330 VERSION 20.0.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM (PCS) PROGRAMMER.
P100016|S002|AAREN SCIENTIFIC INC|4290 EAST BRICKELL STREET|BLDG A|ONTARIO|CA|91761||intraocular lens|EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS|HQL|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2014|04/13/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN ONTARIO, CALIFORNIA.
P930029|S047|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONTACTR|LPB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2014|03/05/2015|||APPR|APPROVAL FOR REVISED SPECIFICATION, MANUFACTURING INSPECTION CRITERIA AND ASSOCIATED MEASUREMENT FIXTURE FOR THE IN-PROCESS INSPECTION OF THE DISTAL CURVE RANGE OF THE RF CONTACTR ABLATION CATHETERS.
P130005|S005|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2014|07/07/2015|||APPR|APPROVAL OF CHANGES TO THE STERILIZATION PROCESS, INCLUDING AN ADDITIONAL STERILIZATION CHAMBER, ALTERNATIVE CONFIGURATIONS FOR PROCESS CHALLENGE DEVICES, REDUCTION IN AERATION TIME, AND ADDITIONAL POST-NITROGEN WASHES AND EVACUATIONS.
P100026|S026|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2014|03/10/2015|||APPR|APPROVAL FOR A MODIFICATION TO THE BATTERY ASSEMBLY TO ADD ADDITIONAL CARBON MONOFLOURIDE (CFX) CATHODE MATERIAL.
P890055|S059|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2014|01/15/2015|||OK30|INSTALLATION OF A NEW PACKAGE SEALER.
P110013|S049|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS_ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|12/18/2014|04/08/2015|||APPR|APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE FOR BOTH THE RAPID EXCHANGE AND OVER-THE-WIRE DELIVERY SYSTEMS WITH THE LATEST AVAILABLE FOLLOW-UP CLINICAL DATA FROM THE VARIOUS STUDIES OF THE GLOBAL RESOLUTE CLINICAL TRIAL PROGRAM.
P010031|S477|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO 11 CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, PROTECTA XT CRT-D,|NIK|CV|Real-Time Process||N|12/18/2014|01/30/2015|||APPR|APPROVAL FOR A MINOR DESIGN TOLERANCE CHANGE AND ASSOCIATEDINSPECTION PROCEDURE CHANGES FOR MULTIPOLAR FEEDTHROUGH INSULATORS FOR SELECTED IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS.
P980016|S513|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO I|LWS|CV|Real-Time Process||N|12/18/2014|01/30/2015|||APPR|APPROVAL FOR A MINOR DESIGN TOLERANCE CHANGE AND ASSOCIATEDINSPECTION PROCEDURE CHANGES FOR MULTIPOLAR FEEDTHROUGH INSULATORS FOR SELECTED IMPLANTABLECARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS.
P010032|S092|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/19/2014|07/09/2015|||APPR|APPROVAL FOR THE ST. JUDE MEDICAL INVISIBLE TRIAL SYSTEM COMPRISING OF THE FOLLOWING DEVICES:1) ST. JUDE MEDICAL EXTERNAL PULSE GENERATOR (EPG), 16 CHANNEL: MODEL 3599; 2) ST. JUDE MEDICAL CLINICIAN PROGRAMMER APP (CP): MODEL 3870;3) ST. JUDE MEDICAL PATIENT CONTROLLER APP (PC): MODEL 3871; AND 4) ASSOCIATED ACCESSORIES (LEAD MODELS 3046, 3066, AND 3086 AND MULTI-LEAD TRIAL CABLE (MLTC) 3013).THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL INVISIBLE TRIAL SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME AND INTRACTABLE LOW BACK AND LEG PAIN. THE ST. JUDE MEDICAL INVISIBLE NEUROMODULATION TRIAL SYSTEM IS INTENDED TO BE USED EXTERNALLY WITH ST. JUDE MEDICAL APPROVED TRIAL LEADS AND EXTENSIONS TO DELIVER TRIAL STIMULATION FOR A MAXIMUM OF 30 DAYS.
P040044|S062|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE)|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/19/2014|03/03/2015|||APPR|APPROVAL FOR MINOR MODIFICATIONS TO THE MYNX ACE DEVICE THAT INVOLVE BUTTON 3, THE PACKAGING TRAY, AND INSTRUCTIONS FOR USE (IFU) ASSOCIATED WITH BUTTON 3.
P110037|S017|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/14/2015|||OK30|RELOCATION OF INSTRUMENTS USED FOR FUNCTIONAL TESTING OF COMPONENTS AND FINISHED DEVICES TO A NEW LABORATORY WITHIN THE SAME MANUFACTURING FACILITY AT PENZBERG, GERMANY.
P100026|S027|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/16/2015|||OK30|MODIFY THE QUALITY CONTROL TEST FOR THE TELEMETRY COIL.
P000012|S051|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/14/2015|||OK30|RELOCATION OF INSTRUMENTS USED FOR FUNCTIONAL TESTING OF COMPONENTS AND FINISHED DEVICES TO A NEW LABORATORY WITHIN THE SAME MANUFACTURING FACILITY AT PENZBERG, GERMANY.
P050028|S043|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/14/2015|||OK30|RELOCATION OF INSTRUMENTS USED FOR FUNCTIONAL TESTING OF COMPONENTS AND FINISHED DEVICES TO A NEW LABORATORY WITHIN THE SAME MANUFACTURING FACILITY AT PENZBERG, GERMANY.
P060030|S044|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/14/2015|||OK30|RELOCATION OF INSTRUMENTS USED FOR FUNCTIONAL TESTING OF COMPONENTS AND FINISHED DEVICES TO A NEW LABORATORY WITHIN THE SAME MANUFACTURING FACILITY AT PENZBERG, GERMANY.
P930014|S077|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ TORIC IOLS|HQL|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/19/2014|02/17/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: UPDATE THE TARGETED NUMBER OF SUBJECTS TO BE IMPLANTED FROM 415 TO 400.
P020036|S031|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|SMART AND SMART CONTROL NITINOL STENT SYSTEM|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|07/31/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT NDC, COSTA RICA, S.R.L., EL COYOL ALAJUELA, COSTA RICA, A CONTRACT MANUFACTURER FOR CORDISSMART AND SMART CONTROL NITINOL STENT SYSTEMS.
P120002|S006|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|SMART AND SMART CONTROL VASCULAR STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|07/31/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT NDC, COSTA RICA, S.R.L., EL COYOL ALAJUELA, COSTA RICA, A CONTRACT MANUFACTURER FOR CORDISSMART AND SMART CONTROL NITINOL STENT SYSTEMS.
P130030|S008|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL MONORAIL AND OVER-THE-WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/15/2015|||OK30|ADD AN ADDITIONAL COATING MACHINE.
P000012|S052|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/15/2015|||OK30|CHANGE TO THE HPLC SYSTEM QUALIFICATION RETENTION TIME WINDOW FOR THE PURIFICATION OF AN OLIGONUCLEOTIDE.
P110037|S018|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/15/2015|||OK30|CHANGE TO THE HPLC SYSTEM QUALIFICATION RETENTION TIME WINDOW FOR THE PURIFICATION OF AN OLIGONUCLEOTIDE.
P110020|S012|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/15/2015|||OK30|CHANGE TO THE HPLC SYSTEM QUALIFICATION RETENTION TIME WINDOW FOR THE PURIFICATION OF AN OLIGONUCLEOTIDE.
P120019|S005|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/19/2014|01/15/2015|||OK30|CHANGE TO THE HPLC SYSTEM QUALIFICATION RETENTION TIME WINDOW FOR THE PURIFICATION OF AN OLIGONUCLEOTIDE.
P980022|S176|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2015|08/25/2015|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO THE DSCAP AND CASE BOTTOM TO INCLUDE A METRIC THREAD INTERFACE FOR THE PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODEL NUMBERS MMT-522, 522K, 523, 523K, 722, 722K, 723, 723K), AND MINIMED 530G INSULIN PUMPS (MODEL NUMBERS MMT-551, 751), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THEMINIMED 530G SYSTEM.
P120010|S052|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2015|08/25/2015|||APPR|APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO THE DSCAP AND CASE BOTTOM TO INCLUDE A METRIC THREAD INTERFACE FOR THE PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODEL NUMBERS MMT-522, 522K, 523, 523K, 722, 722K, 723, 723K), AND MINIMED 530G INSULIN PUMPS (MODEL NUMBERS MMT-551, 751), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THEMINIMED 530G SYSTEM.
P910073|S129|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, ENDOTAK RELIANCE 4-SITE LEAD FAMILY|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2014|03/19/2015|||APPR|APPROVAL FOR CHANGING FROM OXYFUME TO 100% ETHYLENE OXIDE STERILIZATION AND UPDATED LABELING.
P010012|S383|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY SPIRAL LEADS|OJX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/22/2014|03/19/2015|||APPR|APPROVAL FOR CHANGING FROM OXYFUME TO 100% ETHYLENE OXIDE STERILIZATION AND UPDATED LABELING.
P120022|S005|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN EGFR RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2014|01/16/2015|||OK30|CHANGE TO THE SUPPLIER¿S PURITY TESTING METHOD FOR THE INTERNAL CONTROL TEMPLATE IN YOUR THERASCREEN EGFR RGQ PCR KIT. THE NEW PURITY TESTING WILL USE REVERSED PHASE-ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (RP-UPLC) WITH A CHANGE IN ACCEPTANCE CRITERION FROM >=90% TO >=80%.
P100033|S002|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Prostrate cancer genes nucleic acid amplification test system|PROGENSA PCA3 ASSAY|OYM|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2014|01/21/2015|||OK30|MANUFACTURING SCALE UP OF THE SELECTION REAGENT USED IN THE PROGENSA PCA3 ASSAY.
P060038|S022|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MTROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2014|01/21/2015|||OK30|CHANGE TO THE INCOMING QUALITY CONTROL INSPECTION FOR THE OCTANEDIOL SOLUTION.
P830055|S154|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2014|01/21/2015|||OK30|CHANGE A MANUFACTURING STEP FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS.
P030017|S211|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice||N|12/22/2014|01/21/2015|||OK30|MOVING CONTACT PADDLE LEAD MANUFACTURING PROCESSES TO A BOSTON SCIENTIFIC FACILITY.
P010030|S059|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|11/06/2015|||APPR|APPROVAL FOR:1) REDESIGNED ECG AND BELT NODE PCAS; 2) ADDITION OF A FERRITE BEAD TO THE TRUNK CABLE ASSEMBLY AND MODIFICATION TO THE BELT NODE PLASTIC ENCLOSURE; 3) CONNECTORIZED THERAPY ELECTRODE (TE); 4) THERAPY ELECTRODE GAS GENERATOR PLASTIC ENCLOSURE INSPECTION WINDOW; 5) ADDITION OF AN ACCELEROMETER TO THE FRONT TE AND ADDITIONAL CONDUCTORS TO THE CABLE ASSEMBLIES6) ADDITION OF THE TE ADVISORY LABELS TO THE ELECTRODE BELT.
P960016|S052|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETERS|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2014|01/15/2015|||APPR|APPROVAL FOR THE ADDITION OF A NEW EFFECTIVE LENGTH INSPECTION.
P110027|S003|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN KRAS RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2014|01/16/2015|||OK30|CHANGE TO THE SUPPLIERS PURITY TESTING METHOD FOR THE INTERNAL CONTROL TEMPLATE IN YOUR THERASCREEN KRAS RGQ PCR KIT. THE NEW PURITY TESTING WILL USE REVERSED PHASE-ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (RP-UPLC) WITH A CHANGE IN ACCEPTANCE CRITERION FROM >=90% TO >=80%.
P060028|S005|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|03/02/2015|||APPR|APPROVAL FOR A CHANGE TO A LOW BLEED PATCH DESIGN FOR MEMORYSHAPE BREAST IMPLANTS.
P890003|S326|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ELITE,ELITE II,MINUET,PREVA,PRODIGY,THERA D,THERA DR IPGS, THERA ID PG,THERA IPG,THERA S IPG,THERA SR IPG,THERA VDD IPG,|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P010015|S255|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA,SYNCRA,VIVA CRT-PS,INSYNC IPG|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P010031|S478|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|BRAVA,BRAVA QUAD,CONCERTO II,CONSULTA,MAXIMO II,PROTECTA,PROTECTA XT,VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CRT-DS, C|OSR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P090013|S165|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P820003|S132|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYMBIOS,SYNERGYST IPGS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P850051|S082|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACTIVITRAX II IPG,ACTIVITRAX IPG,LEGEND II IPG,LEGEND IPG,MICRO MINIX IPG,MINIX IPG,MINIX ST IPG,PREMIER IPG,PREVAIL IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P900061|S133|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC GEM ICD,MEDTRONIC JEWEL ICD,MEDTRONIC JEWEL PLUS ICD,MEDTRONIC MICRO JEWEL ICD,MEDTRONIC MICRO JEWEL II ICD,ME|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P920015|S146|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P860057|S130|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIIAL AORTIC BIOPROSTHESIS, THEON PERICARDINAL AORTIC BIOPROSTHESIS WITH THERMAFIX T|DYE|CV|Special (Immediate Track)||N|12/22/2014|01/12/2015|||APPR|APPROVAL FOR AN ADDITIONAL GLUTERALDEHYDE CHANGE-OUT STEP IN THE MANUFACTURING PROCESS AND RELATED MANUFACTURING PROCEDURE UPDATES TO REFLECT THIS NEW STEP.
P020004|S110|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|12/22/2014|01/22/2015|||OK30|IMPLEMENTATION OF MODIFIED THERMAL PROCESSING PARAMETERS FOR THE ULTRA THIN WALL BASETUBE GRAFT COMPONENT.
P040043|S071|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice||N|12/22/2014|01/22/2015|||OK30|IMPLEMENTATION OF MODIFIED THERMAL PROCESSING PARAMETERS FOR THE ULTRA THIN WALL BASETUBE GRAFT COMPONENT.
P930022|S017|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LEGEND PLUS IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P970012|S096|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|KAPPA 400 DR IPG,KAPPA 400 SR IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P980016|S514|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD, GEM II VR ICD,GEM III VR ICD,I|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P980035|S404|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P980050|S097|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P990001|S119|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2014|10/19/2015|||APPR|APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
P120005|S032|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2014|01/22/2015|||OK30|CHANGE TO THE MANUFACTURING OF THE SENSOR COMPONENT ADHESIVE PATCH TO SUPPORT PEEL ADHESION TEST SPECIFICATIONS. THE SENSOR IS A COMPONENT OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
P040045|S049|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice||N|12/23/2014|01/22/2015|||OK30|ENHANCEMENT OF IN-PROCESS CONTROL POINT LENS SENSOR FOR THEVISTAKON (SENOFILCON A) AND (ETAFILCON A) BRAND CONTACT LENSES.
P930029|S048|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2014|03/05/2015|||APPR|APPROVAL FOR CHANGES TO LABELING AND PACKAGING FOR SPECIFIC ACCESSORIES (I.E., CABLES AND FOOT SWITCH) USED WITH THE MEDTRONIC ATAKR RFCA SYSTEMS.
P080027|S019|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2014|01/28/2015|||OK30|CHANGE TO THE REAGENT DISPENSING SYSTEM USED IN THE MANUFACTURE OF THE DEVICE.
N18033|S075|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice||N|12/23/2014|01/22/2015|||OK30|ENHANCEMENT OF IN-PROCESS CONTROL POINT LENS SENSOR FOR THEVISTAKON (SENOFILCON A) AND (ETAFILCON A) BRAND CONTACT LENSES.
P980040|S056|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, INTRAOCULAR, TORIC OPTICS|TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM|MJP|OP|Normal 180 Day Track||N|12/24/2014|03/17/2015|||APPR|APPROVAL FOR A CHANGE TO THE PACKAGING OF THE MODEL SERIES ZCT INTRAOCULAR LENSES (IOL) FROM A WHEELCASE CONFIGURATION TO A PRELOADED PACKAGING CONFIGURATION/DELIVERY SYSTEM. THE PRELOADED LENS MODELS WILL BE BRANDED UNDER THE NAME ¿TECNIS® TORIC 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODELS PCT150, PCT225, PCT300 AND PCT400.¿
P120007|S003|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV 16 18/45 GENOTYPE ASSAY|OYB|MI|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|12/24/2014|06/05/2015|||APPR|APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA HPV 16 18/45 GENOTYPE ASSAY. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) OF HUMAN PAPILLOMAVIRUS (HPV) TYPES 16, 18, AND 45 IN CERVICAL SPECIMENS FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN DIFFERENTIATE HPV 16 FROM HPV 18 AND/OR HPV 45, BUT DOES NOT DIFFERENTIATE BETWEEN HPV 18 AND HPV 45. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV 16 18/45 GENOTYPE ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM.  FOR FURTHER INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
P010031|S479|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2014|01/21/2015|||OK30|UPDATE TO THE SPUTTER MASK USED ON THE FEEDTHROUGH INSULATORS AS WELL THE ADDITION OF A SECOND SOURCE SUPPLIER FOR THE FEEDTHROUGH INSULATOR.
P980016|S515|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2014|01/21/2015|||OK30|UPDATE TO THE SPUTTER MASK USED ON THE FEEDTHROUGH INSULATORS AS WELL THE ADDITION OF A SECOND SOURCE SUPPLIER FOR THE FEEDTHROUGH INSULATOR.
P860047|S029|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT OVD|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2014|03/03/2015|||APPR|APPROVAL TO REPLACE THE 25 GAUGE CANNULA THAT IS PACKAGED WITH THE1 ML OCUCOAT PRODUCT WITH A 23 GAUGE CANNULA.
P090031|S004|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|MONOVISC INJECTABLE INTRA-ARTICULAR DEVICES|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2014|05/05/2015|||APPR|APPROVAL FOR AN ALTERNATE RAW MATERIAL SUPPLIER.
P030019|S022|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC INJECTABLE INTRA-ARTICULAR DEVICES|MOZ|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2014|05/05/2015|||APPR|APPROVAL FOR AN ALTERNATE RAW MATERIAL SUPPLIER.
P930029|S049|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.|LPB|CV|Real-Time Process||N|12/24/2014|02/12/2015|||APPR|APPROVAL FOR DESIGN CHANGES FOR CABLES AND FOOT SWITCHES REQUIRED TO MEET ROHS COMPLIANCE.
P010032|S093|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/24/2014|07/06/2015|||APPR|APPROVAL FOR 1) ADDITION OF THE PENTA LEAD TO THE PROTÉGÉ MRI NEUROSTIMULATION SYSTEM AND RELATED LABELING CHANGES; AND 2) REMOVAL OF A WARNING CONCERNING A PATIENT WITH A FEVER UNDERGOING AN MRI SCAN.
P010032|S094|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2014|03/24/2015|||APPR|APPROVAL FOR MINOR DESIGN CHANGES TO THE 8-CHANNEL ADAPTER (MODELS 2311 AND 2316) TO INTRODUCE A NEW 8-CHANNEL ADAPTER (MODELS 2321 AND 2326) FOR THE SPINAL CORD STIMULATION SYSTEM.  THE NEW 8-CHANNEL ADAPTER IS INTENDED TO CONNECT A COMPATIBLE 8-CHANNEL BOSTON SCIENTIFIC LEAD OR EXTENSION TO A COMPATIBLE ST. JUDE MEDICAL IMPLANTABLE PULSE GENERATOR.
P100042|S004|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|12/24/2014|06/05/2015|||APPR|APPROVAL FOR A POST APPROVAL STUDY LABELING UPDATE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA HPV ASSAY. THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, AND 68. THE APTIMA HPV ASSAY DOES NOT DISCRIMINATE BETWEEN THE 14 HIGH-RISK TYPES. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM.THE USE OF THE TEST IS INDICATED:1) TO SCREEN WOMEN 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY; AND2) IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV ASSAY CAN BE USED WITH CERVICAL CYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN¿S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.* BROOM-TYPE DEVICE (E.G., WALLACH PIPETTE) OR ENDOCERVICAL BRUSH/SPATULA.
P980037|S045|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/24/2014|03/31/2015|||APPR|APPROVAL FOR THE ADDITION OF AN INRUSH CURRENT LIMITER TO THE ANGIOJET ULTRA CONSOLE.
P970051|S127|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2014|01/23/2015|||OK30|EIGHT CHANGES TO THE BIOBURDEN MONITORING AND PROCESSING.
P130016|S010|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2014|01/23/2015|||OK30|EIGHT CHANGES TO THE BIOBURDEN MONITORING AND PROCESSING.
P010029|S021|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2014|01/21/2015|||OK30|PROPOSED REVISED STABILITY PROTOCOL.
P970004|S187|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/2014|06/26/2015|||APPR|APPROVAL FOR THE MODEL 3579 CABLE AND MODEL 3676 CABLE AND ASSOCIATED CHANGES TO ENABLE USE OF THE APPROVED VERIFY¿ EVALUATION SYSTEM WITH THE APPROVED TEMPORARY TEST STIMULATION LEADS.
P080025|S083|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR URINARY CONTROL AND BOWEL CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/29/2014|06/26/2015|||APPR|APPROVAL FOR THE MODEL 3579 CABLE AND MODEL 3676 CABLE AND ASSOCIATED CHANGES TO ENABLE USE OF THE APPROVED VERIFY EVALUATION SYSTEM WITH THE APPROVED TEMPORARY TEST STIMULATION LEADS.
P120010|S053|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2014|01/29/2015|||OK30|CHANGE TO THE GLUCOSE OXIDASE COATING VOLUME DURING THE ENLITE GLUCOSE SENSOR (MMT-7008) FABRICATION STEP. THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P040046|S013|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track|Other Report|N|12/30/2014|08/05/2015|||APPR|APPROVAL FOR TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES THAT INCLUDE: FOUR (4) SIZES OF STYLE FL 410; FOUR (4) SIZES OF STYLE ML 410; ONE (1) SIZE OF STYLE LM 410; THREE (3) SIZES OF STYLE LL 410; TWO (2) SIZES OF STYLE LF 410; FOUR (4) SIZES OF STYLE FX 410; FOUR (4) SIZES OF STYLE MX 410; AND SIX (6) SIZES OF STYLE LX 410. THESE TWENTY-EIGHT (28) ADDITIONAL NATRELLE 410 DEVICES ENCOMPASS A RANGE OF: VOLUME = 140-775 CC; WIDTH = 9.5-15.5 CM; HEIGHT = 7.6-16.0 CM; AND PROJECTION = 2.9-7.1 CM.
P090018|S028|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM SYSTEM|OAF|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2014|01/30/2015|||OK30|NEW SUPPLIER FOR THE HEADER COMPONENT OF THE SOUND PROCESSOR.
P960058|S114|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/02/2015|08/14/2015|||APPR|APPROVAL FOR EXPANDING THE NAÍDA CI SOUND PROCESSOR FAMILY, WHICH AREEXTERNAL COMPONENTS OF THE HIRESOLUTION BIONIC EAR SYSTEM, BY ADDING TWO NEW SOUND PROCESSORS (CI Q90 AND CI Q30), NEW VERSIONS OF THE POWERCEL BATTERY, AND A NEW VERSION OF THE SOUNDWAVE PROFESSIONAL SUITE FITTING SOFTWARE.
P980022|S177|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/30/2014|01/22/2016|||APPR|APPROVAL FOR THE ADDITION OF AN ANNEALING PROCESS AND CHEMICAL EXPOSURE DURABILITY TEST FOR THE SMOKE COLOR IN THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-753, MMT-753K) AND MINIMED 530G INSULIN PUMPS (MMT-751). THESE ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL AND MINIMED 530G SYSTEMS, RESPECTIVELY.
P120010|S054|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/30/2014|01/22/2016|||APPR|APPROVAL FOR THE ADDITION OF AN ANNEALING PROCESS AND CHEMICAL EXPOSURE DURABILITY TEST FOR THE SMOKE COLOR IN THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-753, MMT-753K) AND MINIMED 530G INSULIN PUMPS (MMT-751). THESE ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL AND MINIMED 530G SYSTEMS, RESPECTIVELY.
P140010|S001|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2014|01/29/2015|||OK30|CHANGE IN THE DISPENSE HANDLE FOR THE DRUG COATING.
P120010|S055|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR.|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2014|01/30/2015|||OK30|REMOVAL OF TWO ENGINEERING PROCESS LEVEL SPECIFICATIONS FOR A MANUFACTURING STEP IN THE ENLITE SENSOR ASSEMBLY. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P120010|S056|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|01/06/2015|03/20/2015|||APPR|APPROVAL FOR ADDITIONAL MANUFACTURING TESTING TO BE PERFORMED ON A DIFFERENT VERSION OF A COMPONENT USED IN THE MANUFACTURE OF THE MINIMED 530G INSULIN PUMP MMT-551, MMT-751 THAT IS PART OF THE MINIMED 530G SYSTEM.
P110038|S009|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/06/2015|03/06/2015|||APPR|APPROVAL TO INCREASE THE RATE OF ENROLLMENT TO A MORE ACCEPTABLE RATE IN THE POST-APPROVAL STUDY PROTOCOL.
P100023|S113|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2015|02/04/2015|||OK30|UPDATE TO THE ANNUAL STABILITY PROTOCOL.
P950020|S071|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2015|02/04/2015|||OK30|UPDATE TO THE ADHESIVE MIXING SOFTWARE AND ASSOCIATED MANUFACTURING WORK INSTRUCTIONS.
P860057|S131|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2015|01/30/2015|||OK30|NEW BOVINE TISSUE SUPPLIER.
P100041|S062|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2015|01/30/2015|||OK30|NEW BOVINE TISSUE SUPPLIER.
P110021|S049|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2015|01/30/2015|||OK30|NEW BOVINE TISSUE SUPPLIER.
P130009|S022|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN CT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2015|01/30/2015|||OK30|NEW BOVINE TISSUE SUPPLIER.
P950037|S146|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DEXTRUS, SETROX S, TILDA, SAFIO S|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2015|02/02/2015|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE EJECTION OF MOLDED PARTS OF THE LEAD FIXATION HELIX IN THE DEVICES.
P980023|S063|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART SD, LINOX SMART S, VOLTA 1CR, VOLTA 2CR|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2015|02/02/2015|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE EJECTION OF MOLDED PARTS OF THE LEAD FIXATION HELIX IN THE DEVICES.
P130009|S023|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS EXPANDABLE INTRODUCER SHEATH SET|NPT|CV|30-Day Notice||N|01/09/2015|02/05/2015|||OK30|MULTIPLE MODIFICATIONS TO THE MANUFACTURING OF THE INTRODUCER SHEATH RELATED TO THE MARKER BAND ON THE SHEATH SHAFT.
N970012|S103|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2015|04/07/2015|||APPR|APPROVAL FOR MODIFICATION OF AMS 800 INHIBIZONE (IZ) LABELING TO MATCH THE AMS 700 IZ LABELING; MODIFY TERMS FOR CLARITY AND ACCURACY, AND MODIFY THE LABELING TO CLARIFY THE UPPER QUANTITY OF IZ COATING ON THE DEVICE.
P860004|S219|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED IMPLANTABLE INFUSION PUMPS|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2015|02/06/2015|||OK30|VASCUTEK TO MANUFACTURE THE ENTIRE MESH POUCH WITH YARN SUPPLIED BY BRILEN.
P000053|S054|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER|EZY|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/09/2015|04/07/2015|||APPR|APPROVAL FOR MODIFICATION OF AMS 800 INHIBIZONE (IZ) LABELING TO MATCH THE AMS 700 IZ LABELING; MODIFY TERMS FOR CLARITY AND ACCURACY, AND MODIFY THE LABELINGTO CLARIFY THE UPPER QUANTITY OF IZ COATING ON THE DEVICE.
P840001|S288|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2015|02/06/2015|||OK30|CHANGES TO THE SOFTWARE AND PROCEDURES FOR THE DIE SORTER EQUIPMENT.
P860004|S218|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2015|02/06/2015|||OK30|CHANGES TO THE SOFTWARE AND PROCEDURES FOR THE DIE SORTER EQUIPMENT.
P960009|S213|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2015|02/06/2015|||OK30|CHANGES TO THE SOFTWARE AND PROCEDURES FOR THE DIE SORTER EQUIPMENT.
P970004|S188|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2015|02/06/2015|||OK30|CHANGES TO THE SOFTWARE AND PROCEDURES FOR THE DIE SORTER EQUIPMENT.
P080025|S084|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/09/2015|02/06/2015|||OK30|CHANGES TO THE SOFTWARE AND PROCEDURES FOR THE DIE SORTER EQUIPMENT.
P090013|S166|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/10/2015|||OK30|TRANSFER OF A SECONDARY SUPPLIERS MANUFACTURING FACILITY AND ASSOCIATED BORON DOPING PROCESS CHANGE.
P130024|S002|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX 035 DRUG COATED BALLOON PTA CATHETER|ONU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/12/2015|06/30/2015|||APPR|APPROVAL FOR THE 120 MM AND 150 MM DEVICE SIZES.
P910001|S077|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/05/2015|||OK30|ADD AN ADDITIONAL COMPONENT SUPPLIER FOR THE CVX-300 AND CVX-300-P LASER SYSTEM.
P840001|S290|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/11/2015|||OK30|CHANGE THE INSPECTION CRITERIA ON AN INSULATOR SUBASSEMBLY.
P960009|S215|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/11/2015|||OK30|CHANGE THE INSPECTION CRITERIA ON AN INSULATOR SUBASSEMBLY.
P010015|S256|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/02/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS, A NEW MEASUREMENT SYSTEM, FOR THE BATTERY CASE SUBASSEMBLY FOR THE DEVICES.
P010031|S480|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D'S;  BRAVA QUAD CRT-D'S;  CONCERTO II CRT-D; CONSULTA CRT-D; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/09/2015|||OK30|IMPLEMENTATION OF AN ADDITIONAL WELD STRENGTH PROOF TEST.
P010015|S257|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/09/2015|||OK30|IMPLEMENTATION OF AN ADDITIONAL WELD STRENGTH PROOF TEST.
P980016|S516|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD; VR ICD, EVERTA XT DR ICD; EVERA XT VR ICD, MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD , SECURA ICD; VI|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/09/2015|||OK30|IMPLEMENTATION OF AN ADDITIONAL WELD STRENGTH PROOF TEST.
P810002|S093|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/10/2015|||OK30|IMPLEMENTATION OF NEW EQUIPMENT FOR SILICON WEIGHT PERCENT MEASUREMENT OF THE ORIFICE AND LEAFLET COMPONENTS OF SJM MECHANICAL HEART VALVES.
P840001|S289|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/10/2015|||OK30|SUPPLIER FACILITY CHANGE AND A CHANGE IN DOPING MATERIAL APPLICATION PROCESS.
P860004|S220|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/10/2015|||OK30|SUPPLIER FACILITY CHANGE AND A CHANGE IN DOPING MATERIAL APPLICATION PROCESS.
P960009|S214|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/10/2015|||OK30|SUPPLIER FACILITY CHANGE AND A CHANGE IN DOPING MATERIAL APPLICATION PROCESS.
P970004|S189|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/10/2015|||OK30|SUPPLIER FACILITY CHANGE AND A CHANGE IN DOPING MATERIAL APPLICATION PROCESS.
P080025|S085|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/10/2015|||OK30|SUPPLIER FACILITY CHANGE AND A CHANGE IN DOPING MATERIAL APPLICATION PROCESS.
N970012|S104|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/12/2015|||OK30|IMPLEMENTATION OF ALTERNATIVE AUTOMATED MANUFACTURING MIXING EQUIPMENT.
P000053|S055|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2015|02/12/2015|||OK30|IMPLEMENTATION OF ALTERNATIVE AUTOMATED MANUFACTURING MIXING EQUIPMENT.
P100025|S008|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATHTEK UBT FOR H.PYLORI KIT|OZA|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/13/2015|03/05/2015|||APPR|APPROVAL FOR AN AMENDMENT TO THE DRUG MASTER FILE FOR THE FOLLOWING CHANGES:  1) ADDITIONAL PROCESS DEVELOPMENT WORK FOR THE PURIFICATION PROCESS; 2) VALIDATION OF THE PURIFICATION PROCESS IMPROVEMENTS;3) SITE TRANSFER FOR THE PURIFICATION PROCESS; 4) CHANGE TO A SPECIFICATION OF A STARTING MATERIAL; 5. ADDITIONAL SIZES FOR THE OUTER CONTAINER AND INNER BAGS FOR THE PURIFICATION PROCESS; AND 6) UPDATED STABILITY INFORMATION.
P920047|S076|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/13/2015|04/06/2015|||APPR|APPROVAL FOR A DESIGN CHANGE TO SYSTEM CABLES FROM LEAD CONTAININGSOLDER TO LEAD-FREE SOLDER.
P020025|S067|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/13/2015|04/06/2015|||APPR|APPROVAL FOR A DESIGN CHANGE TO SYSTEM CABLES FROM LEAD CONTAININGSOLDER TO LEAD-FREE SOLDER.
P980003|S056|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/13/2015|04/06/2015|||APPR|APPROVAL FOR A DESIGN CHANGE TO SYSTEM CABLES FROM LEAD CONTAININGSOLDER TO LEAD-FREE SOLDER.
P060040|S038|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II  LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2015|02/12/2015|||APPR|APPROVAL FOR IMPLEMENTATION OF AN ADDITIONAL EXISTING ELECTRICAL CONTINUITY TEST DURING THE  MANUFACTURING PROCESS OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS).
P100026|S028|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/13/2015|04/08/2015|||APPR|APPROVAL FOR A LABELING CHANGE TO STATE THE CALCULATED BATTERY LIFECONSISTENTLY THROUGHOUT THE INSTRUCTION MANUALS.
P860057|S132|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, WITH THERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIO|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2015|02/11/2015|||OK30|UPGRADE TO THE LABELING SOFTWARE USED TO GENERATE FINISHED DEVICE LABELS.
P100041|S063|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2015|02/11/2015|||OK30|UPGRADE TO THE LABELING SOFTWARE USED TO GENERATE FINISHED DEVICE LABELS.
P110021|S050|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice||N|01/13/2015|02/11/2015|||OK30|UPGRADE TO THE LABELING SOFTWARE USED TO GENERATE FINISHED DEVICE LABELS.
P130009|S024|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2015|02/11/2015|||OK30|UPGRADE TO THE LABELING SOFTWARE USED TO GENERATE FINISHED DEVICE LABELS.
P070015|S127|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2015|02/06/2015|||OK30|IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.
P110019|S074|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2015|02/06/2015|||OK30|IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.
P020047|S061|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION,MULTI-LINK MINI VISION,MULTI-LINK 8 CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2015|02/06/2015|||OK30|IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.
P970020|S081|ABBOTT VASCULAR INC.|26531 YNEZ ROAD||TEMECULA|CA|92591||STENT, CORONARY|MULTI-LINK ULTRA CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2015|02/06/2015|||OK30|IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.
P110028|S014|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR STENT SYSTEMS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2015|02/06/2015|||OK30|IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.
P040012|S054|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2015|02/06/2015|||OK30|IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION.
P990065|S008|SIRTEX MEDICAL LIMITED|UNIT F6 PARKVIEW 16 MARS ROAD||LANE COVE||NSW 2||Microspheres radionuclide|SIR-SPHERES MICROSPHERES|NAW|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2015|02/27/2015|||OK30|ADDITION OF A NEW CLEANROOM WITH TWO NEW PRODUCTION HOT CELLS AND ASSOCIATED EQUIPMENT TO EXISTING MANUFACTURING SPACE.
P000023|S011|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Joint, temporomandibular, implant|TMJ FOSSA-EMINENCE AND CONDYLAR  PROSTHESIS SYSTEM|LZD|DE|30-Day Notice||N|01/16/2015|02/13/2015|||OK30|CHANGES IN TWO CLEANING PROCESSES.
P000035|S011|NEXUS CMF, LLC|17301 WEST COLFAX AVENUE|SUITE 170|GOLDEN|CO|80401||Glenoid fossa prosthesis|TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM|MPI|DE|30-Day Notice||N|01/16/2015|02/13/2015|||OK30|CHANGES IN TWO CLEANING PROCESSES.
P070007|S038|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT THORACIC STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/16/2015|04/05/2016|||APPR|Approval of the following changes to the post-approval study for the device:  sponsor proposes to terminate its THRIVE Trial PAS due to the device no longer beingmanufactured or commercially available.
N970003|S170|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|FORMIO, VITALIO, INGENIO, ADVANTIO, ACCOLADE, PROPONENT, ESSENTIO, & ALTRUA 2 PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2015|02/25/2015|||APPR|APPROVAL FOR A PROGRAMMING APPLICATION SOFTWARE CHANGE FOR SELECTEDPACEMAKERS AND CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS.
P030005|S116|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INTUA, INVIVE, VALITUDE, & VALITUDE X4 CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/16/2015|02/25/2015|||APPR|APPROVAL FOR A PROGRAMMING APPLICATION SOFTWARE CHANGE FOR SELECTEDPACEMAKERS AND CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS.
P030026|S029|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/16/2015|02/12/2015|||OK30|CHANGE TO SCALE UP THE MANUFACTURING PROCESS FOR A DEVICE COMPONENT.
P010031|S481|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/07/2015|||OK30|UPDATE THE CLEANING PROCESS AT A SUPPLIER FOR THE CERAMIC ALUMINA INSULATOR SEAT IN FEEDTHROUGH ASSEMBLY.
P980016|S517|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/07/2015|||OK30|UPDATE THE CLEANING PROCESS AT A SUPPLIER FOR THE CERAMIC ALUMINA INSULATOR SEAT IN FEEDTHROUGH ASSEMBLY.
P810002|S094|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|ST. JUDE MEDICAL MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/19/2015|||OK30|IMPLEMENTATION OF AN UPDATE TO THE RECEIVING INSPECTION CRITERIA OF SEAL STRENGTH FOR THE LID MATERIAL USED IN DEVICE PACKAGING.
P980035|S405|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAOTA, VERSA, SENSIA IPG, ADVISSA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/07/2015|||OK30|MINOR UPDATE TO THE SOFTWARE CONFIGURATION OF THE INTEGRATED CIRCUIT DIE SORTER EQUIPMENT.
P840001|S291|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/19/2015|||OK30|CHANGE TWO MANUFACTURING INSPECTION STEPS.
P100026|S029|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/19/2015|||OK30|ADD ALTERNATE TEST EQUIPMENT FOR BATTERIES.
P010014|S050|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/19/2015|||OK30|REMOVAL OF A STEP FROM THE MANUFACTURING PROCESS.
P010015|S258|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA  CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/07/2015|||OK30|MINOR UPDATE TO THE SOFTWARE CONFIGURATION OF THE INTEGRATED CIRCUIT DIE SORTER EQUIPMENT.
P010031|S482|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUARD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/07/2015|||OK30|MINOR UPDATE TO THE SOFTWARE CONFIGURATION OF THE INTEGRATED CIRCUIT DIE SORTER EQUIPMENT.
P090013|S167|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/07/2015|||OK30|MINOR UPDATE TO THE SOFTWARE CONFIGURATION OF THE INTEGRATED CIRCUIT DIE SORTER EQUIPMENT.
P980016|S518|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, PROTECTA XT ICD, SECUR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2015|02/07/2015|||OK30|MINOR UPDATE TO THE SOFTWARE CONFIGURATION OF THE INTEGRATED CIRCUIT DIE SORTER EQUIPMENT.
P110027|S004|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|QIAGEN THERASCREEN KRAS RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/13/2015|||OK30|NEW ASSEMBLY LINE FOR MANUFACTURING (ASSEMBLING) QIAAMP MINELUTE SPIN COLUMNS USED TO ISOLATE AND PURIFY DNA.
P120022|S006|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|QIAGEN THERASCREEN EGFR RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/13/2015|||OK30|NEW ASSEMBLY LINE FOR MANUFACTURING (ASSEMBLING) QIAAMP MINELUTE SPIN COLUMNS USED TO ISOLATE AND PURIFY DNA.
P110027|S005|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN KRAS RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/19/2015|||OK30|CHANGE OF FILLING PROCESS FOR PROTEINASE K IN THE QIAAMP DSP DNA FFPE TISSUE KIT FROM A MANUAL TO AN AUTOMATED PROCESS AT THE HILDEN, GERMANY FACILITY.
P120022|S007|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN EGFR RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/19/2015|||OK30|CHANGE OF FILLING PROCESS FOR PROTEINASE K IN THE QIAAMP DSP DNA FFPE TISSUE KIT FROM A MANUAL TO AN AUTOMATED PROCESS AT THE HILDEN, GERMANY FACILITY.
P040021|S026|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR, EPIC AND EPIC SUPRA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/12/2015|||OK30|FIVE NEW TISSUE SUPPLIERS.
P100029|S019|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/12/2015|||OK30|FIVE NEW TISSUE SUPPLIERS.
P920015|S147|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD,  SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/07/2015|||OK30|SECOND SOURCE SUPPLIER FOR FIVE LEAD COMPONENTS (SCREW-IN CONNECTOR RING, ROTATING CONNECTOR PIN, CF-1 ELECTRODE PIN, SCREW-IN CONNECTOR RING, AND FOUR POLE LEAD CONNECTOR RING) USED IN THE DEVICES.
P030036|S076|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/07/2015|||OK30|SECOND SOURCE SUPPLIER FOR FIVE LEAD COMPONENTS (SCREW-IN CONNECTOR RING, ROTATING CONNECTOR PIN, CF-1 ELECTRODE PIN, SCREW-IN CONNECTOR RING, AND FOUR POLE LEAD CONNECTOR RING) USED IN THE DEVICES.
P090013|S168|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/07/2015|||OK30|SECOND SOURCE SUPPLIER FOR FIVE LEAD COMPONENTS (SCREW-IN CONNECTOR RING, ROTATING CONNECTOR PIN, CF-1 ELECTRODE PIN, SCREW-IN CONNECTOR RING, AND FOUR POLE LEAD CONNECTOR RING) USED IN THE DEVICES.
P930039|S124|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/07/2015|||OK30|SECOND SOURCE SUPPLIER FOR FIVE LEAD COMPONENTS (SCREW-IN CONNECTOR RING, ROTATING CONNECTOR PIN, CF-1 ELECTRODE PIN, SCREW-IN CONNECTOR RING, AND FOUR POLE LEAD CONNECTOR RING) USED IN THE DEVICES.
P110035|S029|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2015|02/09/2015|||OK30|NEW PLASMA UNIT USED DURING THE RACK BONDING PROCESS FOR THE EPIC VASCULAR SELF-EXPANDING NITINOL STENT SYSTEM.
P870076|S016|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING BAND APPLICATOR KITS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2015|02/19/2015|||OK30|ADDITION OF A PACKAGE SEALING EQUIPMENT.
P970018|S031|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPMATE SLIDE PROCESSOR, BD PREPMATE AUTOMATED ACCESSORY|MKQ|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2015|06/14/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED SPARKS, MD.
P010031|S483|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2015|02/12/2015|||OK30|IMPLEMENTATION OF A NEW 3D LASER MARKER.
P090013|S169|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2015|02/12/2015|||OK30|IMPLEMENTATION OF A NEW 3D LASER MARKER.
P980016|S519|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2015|02/12/2015|||OK30|IMPLEMENTATION OF A NEW 3D LASER MARKER.
P980035|S406|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPGS, ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2015|02/12/2015|||OK30|IMPLEMENTATION OF A NEW 3D LASER MARKER.
P050006|S045|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX EX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|02/19/2015|||OK30|MODIFICATION TO THE DELIVERY CATHETER LINER RESIN.
P130007|S001|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|01/23/2015|04/14/2015|||APPR|APPROVAL FOR IMPLEMENTATION OF DEXCOM¿S APPROVED SINGLE-PRINTED WIRING ASSEMBLY (PWA) CONFIGURATION TRANSMITTER INTO THE ANIMAS VIBE SYSTEM AS AN ALTERNATIVE TO THE CURRENT DUAL-PWA DESIGN.
P980016|S521|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II, PROTECTA, PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/23/2015|03/30/2015|||APPR|APPROVAL FOR THE D453 IC TO BE USED IN THE DEVICES.
P010031|S485|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/23/2015|03/30/2015|||APPR|APPROVAL FOR THE D453 IC TO BE USED IN THE DEVICES.
P840064|S059|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT OPHTHALMIC VISCOSURICAL DEVICE, DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|04/10/2015|||APPR|APPROVAL TO REPLACE THE CURRENT PRODUCT RELEASE INTRAVITREAL TEST WITH THE INFLAMMATORY RELEASE ASSAY (IRA) PRODUCT RELEASE TEST.
P840001|S292|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|02/20/2015|||OK30|CHANGE THE EPOXY MIX RATIO AND THE EQUIPMENT USED TO DISPENSE THE EPOXY.
P960009|S216|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|02/20/2015|||OK30|CHANGE THE EPOXY MIX RATIO AND THE EQUIPMENT USED TO DISPENSE THE EPOXY.
P010015|S259|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|02/19/2015|||OK30|AUTOMATION OF A VISUAL INSPECTION OF THE CONNECTOR ASSEMBLY.
P010031|S484|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|02/19/2015|||OK30|AUTOMATION OF A VISUAL INSPECTION OF THE CONNECTOR ASSEMBLY.
P090013|S170|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|02/19/2015|||OK30|AUTOMATION OF A VISUAL INSPECTION OF THE CONNECTOR ASSEMBLY.
P980016|S520|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|02/19/2015|||OK30|AUTOMATION OF A VISUAL INSPECTION OF THE CONNECTOR ASSEMBLY.
P980035|S407|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/23/2015|02/19/2015|||OK30|AUTOMATION OF A VISUAL INSPECTION OF THE CONNECTOR ASSEMBLY.
P030002|S033|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|TRULIGN TORIC WEB-BASED TORIC CALCULATOR|MJP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/26/2015|04/09/2015|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE WEB-BASED TORIC CALCULATOR (WBTC) USED WITH THE TRULIGN TORIC IOL.
P120010|S057|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2015|02/27/2015|||OK30|REMOVAL OF A CONDUCTIVITY TEST FOR A SOLUTION USED ON THE MANUFACTURE OF ENLITE SENSORS, THE CREATION OF A NEW PART NUMBER FOR THIS SOLUTION AND THE REMOVAL OF ALTERNATE PART NUMBER ALLOWED FOR ENLITE SENSORS MANUFACTURE. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P110027|S006|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|QIAGEN THERASCREEN KRAS RGQ PCR KIT|OWD|PA|Real-Time Process||N|01/26/2015|04/23/2015|||APPR|APPROVAL FOR REPLACEMENT OF LYSIS TUBE IN THE QIAAMP DSP DNA FFPE TISSUE KIT.
P120022|S008|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|QIAGEN THERASCREEN EGFR RGQ PCR KIT|OWD|PA|Real-Time Process||N|01/26/2015|04/23/2015|||APPR|APPROVAL FOR REPLACEMENT OF LYSIS TUBE IN THE QIAAMP DSP DNA FFPE TISSUE KIT.
P110027|S007|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|QIAGEN THERASCREEN KRAS RGQ PCR KIT|OWD|PA|Real-Time Process||N|01/26/2015|04/24/2015|||APPR|APPROVAL FOR REPLACEMENT OF THE RAW MATERIALS USED IN MANUFACTURING OF PRIMARY PACKAGING (BOTTLES AND CAPS) FOR BUFFERS IN THE QIAAMP DSP DNA FFPE TISSUE KIT.
P120022|S009|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|QIAGEN THERASCREEN EGFR RGQ PCR KIT|OWD|PA|Real-Time Process||N|01/26/2015|04/24/2015|||APPR|APPROVAL FOR REPLACEMENT OF THE RAW MATERIALS USED IN MANUFACTURING OF PRIMARY PACKAGING (BOTTLES AND CAPS) FOR BUFFERS IN THE QIAAMP DSP DNA FFPE TISSUE KIT.
P120010|S058|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2015|06/09/2015|||APPR|APPROVAL FOR A CHANGE IN THE PRE-DOSING PROCESS OF THE ENLITE SENSORADHESIVE PATCH. THE ENLITE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P130030|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2015|02/25/2015|||OK30|REMOVE THE INNER COMPONENT TRIMMING PROCESS.
P030017|S212|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/26/2015|02/25/2015|||OK30|SUPPLIER RELOCATION OF PACKAGING AREAS AND COMPONENT   MANUFACTURING PROCESS AREAS.
P140010|S002|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/26/2015|06/19/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P120004|S001|PARASCRIPT, LLC|6273 MONARCH PARK PLACE||LONGMONT|CO|80503||Analyzer,medical image|PARASCRIPT (R) ACCUDETECT (R)|MYN|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/27/2015|10/16/2015|||APPR|APPROVAL FOR PARASCRIPT ACCUDETECT VERSION 7.0.
P970038|S030|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENT ASSAY|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2015|06/09/2015|||APPR|APPROVAL FOR A CHANGE TO THE PROCESS FOR PURIFYING GTXBIOTIN POLYCLONAL ANTIBODY FROM GOAT ANTISERUM.
P000006|S040|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/2015|04/13/2015|||APPR|APPROVAL FOR CHANGES IN THE LABELING OF THE TITAN INFLATABLE PENILE PROSTHESIS SURGICAL PROTOCOL TO INCORPORATE ECTOPIC PLACEMENT.
P050047|S044|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM ULTRA XC INJECTABLE GEL|LMH|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/2015|09/30/2015|15M-3519|10/30/2015|APPR|APPROVAL FOR THE JUVÉDERM ULTRA XC. THIS DEVICE IS INDICATED FOR:1) JUVÉDERM ULTRA XC INJECTABLE GEL IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS); AND 2) JUVÉDERM ULTRA XC IS INDICATED FOR INJECTION INTO THE LIPS AND PERIORAL AREA FOR LIP AUGMENTATION IN ADULTS OVER THE AGE OF 21.
P140010|S003|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/27/2015|06/19/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P130026|S001|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ ABLATION CATHETER|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2015|02/26/2015|||OK30|USE OF AN ALTERNATIVE SUPPLIER FOR THE DISTAL OPTICAL FIBER COMPONENT USED IN THE TACTICATH QUARTZ ABLATION CATHETER.
P130009|S025|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|ASCENDRA + DELIVERY SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2015|02/25/2015|||OK30|NEW NOSE TIP SUPPLIER FOR THE ASCENDRA+ DELIVERY SYSTEM.
P130008|S005|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATOR|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2015|02/27/2015|||OK30|CHANGES TO THE LEAD WELDING, CRIMPING, AND MOLDING PROCESSES AT THE FIRM¿S CONTRACT MANUFACTURER.
P120010|S059|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2015|02/25/2015|||OK30|CHANGE TO AUTOMATE A PROCESS TO PRESS THE GEARBOX SHAFTS INTO THE SUN AND PLANETARY WHEELS OF THE 530G INSULIN PUMP DRIVE MOTOR. THE 530G INSULIN PUMP IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P010031|S486|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA ,  QUAD , VIVA QUAD S  CRT-D'S; VIVA  QUAD S ,   QUAD XT, S  VIVA S CRT-D'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2015|02/26/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS AND SPECIFICATION OF TANTALUM PINS.
P980016|S522|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD,|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2015|02/26/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS AND SPECIFICATION OF TANTALUM PINS.
P910023|S353|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2015|02/18/2015|||OK30|ALTERNATE CASE LID SUPPLIER FOR HIGH VOLTAGE CAPACITORS UTILIZED IN THE DEVICES.
P030054|S282|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2015|02/18/2015|||OK30|ALTERNATE CASE LID SUPPLIER FOR HIGH VOLTAGE CAPACITORS UTILIZED IN THE DEVICES.
P040013|S020|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Biologic material, dental|GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX)|NQA|DE|Special (Immediate Track)||N|01/21/2015|03/09/2015|||APPR|APPROVAL FOR FINAL PATIENT LABELING.
P050033|S018|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|11/03/2015|||APPR|APPROVAL OF AN ALTERNATE SUPPLIER OF A MATERIAL USED IN THE MANUFACTURE HYDRELLE.
P080009|S004|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS|PDR|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/29/2015|03/23/2015|||APPR|APPROVAL OF THE CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.
P980040|S057|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, INTRAOCULAR, TORIC OPTICS|TECNIS TORIC 1-PIECE IOL, MODEL ZCT375|MJP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|01/29/2015|04/17/2015|||APPR|APPROVAL FOR THE TECNIS TORIC 1-PIECE IOL, MODEL ZCT375.
P080009|S005|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/29/2015|03/25/2015|||APPR|APPROVAL OF THE CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.
P010032|S095|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|02/27/2015|||OK30|MANUFACTURING PROCESS CHANGES APPLICABLE TO SHORT ELECTRODES.
P900033|S042|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO|MDD|SU|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2015|01/07/2016|16M-0121|01/11/2016|APPR|APPROVAL FOR THE INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX (A.K.A. OMNIGRAFT) AND INTEGRA DERMAL REGENERATION TEMPLATE. INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX IS INDICATED FOR USE IN THE TREATMENT OF PARTIAL AND FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS THAT ARE GREATER THAN SIX WEEKS IN DURATION, WITH NO CAPSULE, TENDON OR BONE EXPOSED, WHEN USED IN CONJUNCTION WITH STANDARD DIABETIC ULCER CARE AND INTEGRA DERMAL REGENERATION TEMPLATE IS INDICATED FOR THE POSTEXCISIONAL TREATMENT OF LIFE-THREATENING FULL-THICKNESS OR DEEP PARTIAL-THICKNESS THERMAL INJURIES WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE AT THE TIME OF EXCISION OR NOT DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT; REPAIR OF SCAR CONTRACTURES WHEN OTHER THERAPIES HAVE FAILED OR WHEN DONOR SITES FOR REPAIR ARE NOT SUFFICIENT OR DESIRABLE DUE TO THE PHYSIOLOGICAL CONDITION OF THE PATIENT; AND TREATMENT OF PARTIAL AND FULL-THICKNESS NEUROPATHIC DIABETIC FOOT ULCERS THAT ARE GREATER THAN SIX WEEKS IN DURATION WITH NO CAPSULE, TENDON OR BONE EXPOSED, WHEN USED IN CONJUNCTION WITH STANDARD DIABETIC ULCER CARE.
P980016|S523|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR, VR,; EVERA XT DR, EVERA XT VR , MAXIMO II , PROTECTA , PROTECTA XT, SECURA; AND VIRTUOSO II D/RVR ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|02/23/2015|||OK30|ADD AN ADDITIONAL SUPPLIER FOR TANTALUM SUBSTRATES FOR CAPACITORS USED IN THE DEVICES.
P980035|S408|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|02/23/2015|||OK30|ADD AN ADDITIONAL SUPPLIER FOR TANTALUM SUBSTRATES FOR CAPACITORS USED IN THE DEVICES.
P090013|S171|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|02/23/2015|||OK30|ADD AN ADDITIONAL SUPPLIER FOR TANTALUM SUBSTRATES FOR CAPACITORS USED IN THE DEVICES.
P960040|S342|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEBN, PUNCTUA,ENERGEN, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|02/23/2015|||OK30|ADD AN ADDITIONAL SUPPLIER FOR LOW VOLTAGE CAPACITORS USED IN THE DEVICES.
P010012|S384|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||DYNAGEN,INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|02/23/2015|||OK30|ADD AN ADDITIONAL SUPPLIER FOR LOW VOLTAGE CAPACITORS USED IN THE DEVICES.
P020045|S065|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYO-ABLATION CATHETER FAMILIES AND THE ARTIC FRONT|LPB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2015|04/01/2015|||APPR|APPROVAL FOR LABELING CHANGES TO DEVICE ACCESSORIES IN ORDER TO COMPLY WITH IEC 60601-1 3RD EDITION AND/OR TO ALIGN WITH COMPANY POLICY.
P010015|S260|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|02/23/2015|||OK30|ADD AN ADDITIONAL SUPPLIER FOR TANTALUM SUBSTRATES FOR CAPACITORS USED IN THE DEVICES.
P010031|S487|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA- BRAVA QUAD , CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT,VIVA QUAD, QUAD S AND IX CRT-D'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2015|02/23/2015|||OK30|ADD AN ADDITIONAL SUPPLIER FOR TANTALUM SUBSTRATES FOR CAPACITORS USED IN THE DEVICES.
P100010|S047|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT/ ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER FAMILIES OF DEVICES|OAE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2015|04/01/2015|||APPR|APPROVAL FOR LABELING CHANGES TO DEVICE ACCESSORIES IN ORDER TO COMPLY WITH IEC 60601-1 3RD EDITION AND/OR TO ALIGN WITH COMPANY POLICY.
P130009|S026|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice||N|01/30/2015|02/13/2015|||OK30|EXTEND THE SHELF LIFE OF THE POLYTETRA-FLUOROETHYLENE ROUND SUTURE FROM 5 YEARS TO 8 YEARS.
P030017|S213|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|01/30/2015|04/28/2015|||APPR|APPROVAL FOR PACKAGING CHANGES FOR THE PRECISION SPECTRA ORCABLE AND EXTENSIONS.
P120010|S060|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/30/2015|02/25/2015|||OK30|CHANGES TO THE STERILIZATION PROCESS PARAMETERS USED FOR THE ENLITE GLUCOSE SENSOR (MMT-7008A). THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P130005|S006|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEMS (OAS)|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/30/2015|03/18/2015|||APPR|APPROVAL FOR A CHANGE IN THE DESIGN OF THE FLEXIBLE CONTAINER SYSTEM OF THE VIPERSLIDE (LNTRALIPID 10%) LUBRICANT.
P000006|S041|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|03/04/2015|||OK30|IMPLEMENTING USE OF AN ADDITIONAL CAVITY IN AN EXISTING MULTI CAVITY MOLD.
P000006|S042|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|03/04/2015|||OK30|IMPLEMENTING A MODIFIED PREPARATION PROCEDURE FOR TUBING.
P980035|S410|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG.|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/27/2015|||OK30|MANUFACTURING PROCESS CHANGES FOR XE161 CRYSTAL COMPONENT USED IN THE DEVICES.
P010031|S489|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D; BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTCA CRT-D & XT CRT-D, VIVA QUAD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/27/2015|||OK30|MANUFACTURING PROCESS CHANGES FOR XE161 CRYSTAL COMPONENT USED IN THE DEVICES.
P090013|S173|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/27/2015|||OK30|MANUFACTURING PROCESS CHANGES FOR XE161 CRYSTAL COMPONENT USED IN THE DEVICES.
P010015|S262|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/27/2015|||OK30|MANUFACTURING PROCESS CHANGES FOR XE161 CRYSTAL COMPONENT USED IN THE DEVICES.
P980016|S525|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR & VR ICD, EVERA XT DR & VR ICD, MAXIMO II ICD, PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/27/2015|||OK30|MANUFACTURING PROCESS CHANGES FOR XE161 CRYSTAL COMPONENT USED IN THE DEVICES.
P980035|S409|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA VERSA, SENSIA IPG ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/23/2015|||OK30|USE OF A NEW AUTOMATED INSPECTION SYSTEM FOR THE DEVICES FINAL PACKAGE TRAY.
P010015|S261|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/23/2015|||OK30|USE OF A NEW AUTOMATED INSPECTION SYSTEM FOR THE DEVICES FINAL PACKAGE TRAY.
P020050|S019|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRO TOPOLYZER VARIO|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/2015|05/01/2015|||APPR|APPROVAL TO EXPAND THE APPROVAL OF THE TOPOLYZER VARIO TO INCLUDE ITS USE AS A DIAGNOSTIC DEVICE SUPPORTING THE WAVELIGHT EXCIMER LASERS IN PERFORMING T-CAT LASIK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRO TOPOLYZER VARIO AND IS INDICATED FOR THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (TOPOGRAPHER) OR ALLEGRO TOPOLYZER VARIO (TOPOGRAPHER) AND T-CAT TREATMENT PLANNING SOFTWARE IS INDICATED FOR PERFORMING TOPOGRAPHY-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (TOPO-GUIDED (T-CAT) LASIK):1) FOR THE REDUCTION OR ELIMINATION OF UP TO -9.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE;2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50 D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P090013|S172|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/23/2015|||OK30|USE OF A NEW AUTOMATED INSPECTION SYSTEM FOR THE DEVICES FINAL PACKAGE TRAY.
P010031|S488|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/23/2015|||OK30|USE OF A NEW AUTOMATED INSPECTION SYSTEM FOR THE DEVICES FINAL PACKAGE TRAY.
P030008|S017|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM|LZS|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/2015|05/01/2015|||APPR|APPROVAL TO EXPAND THE APPROVAL OF THE TOPOLYZER VARIO TO INCLUDE ITS USE AS A DIAGNOSTIC DEVICE SUPPORTING THE WAVELIGHT EXCIMER LASERS IN PERFORMING T-CAT LASIK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRO TOPOLYZER VARIO AND IS INDICATED FOR THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (TOPOGRAPHER) OR ALLEGRO TOPOLYZER VARIO (TOPOGRAPHER) AND T-CAT TREATMENT PLANNING SOFTWARE IS INDICATED FOR PERFORMING TOPOGRAPHY-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (TOPO-GUIDED (T-CAT) LASIK):1) FOR THE REDUCTION OR ELIMINATION OF UP TO -9.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE;2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50 D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.
P980016|S524|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/23/2015|||OK30|USE OF A NEW AUTOMATED INSPECTION SYSTEM FOR THE DEVICES FINAL PACKAGE TRAY.
P980040|S058|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, INTRAOCULAR, TORIC OPTICS|TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU|MJP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/2015|07/31/2015|||APPR|APPROVAL FOR TECNIS® TORIC 1-PIECE ACRYLIC IOLS, MODELS ZCT450, ZCT525 AND ZCT600, AND THE TECNIS® TORIC CALCULATOR.
P100041|S064|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/27/2015|||OK30|EXTEND A WATER LOOP IN THE DRAPER, UTAH FACILITY.
P110021|S051|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/27/2015|||OK30|EXTEND A WATER LOOP IN THE DRAPER, UTAH FACILITY.
P130009|S027|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/27/2015|||OK30|EXTEND A WATER LOOP IN THE DRAPER, UTAH FACILITY.
P060011|S005|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7||intraocular lens|600C ASPHERIC INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/02/2015|05/01/2015|||APPR|APPROVAL FOR THE FOLLOWING MODIFICATIONS OF THE C-FLEX ASPHERIC IOL MODEL 970C: 1) INCREASE OF OVERALL DIAMETER FROM 12.00 MM TO 12.50 MM; 2) INCREASE OF OPTIC SIZE FROM 5.75 MM TO 6.00 MM; AND 3) AN EXTENSION OF THE HIGH POWERED DIOPTRIC RANGE FROM +30.0D TO +34.0D. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 600C ASPHERIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATIONTHE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
P070015|S128|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/2015|09/23/2015|15M-3516|10/15/2015|APPR|APPROVAL FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE DEVICES ARE INDICATED FOR THE FOLLOWING:XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM.  THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.25 MM. ADDITIONALLY, THE XIENCE V STENT IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM.  THE XIENCE PRIME STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32 MM) WITH REFERENCE VESSEL DIAMETERS OF >=2.25 MM TO <= 4.25 MM.ADDITIONALLY, THE XIENCE PRIME STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.  XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM.THE XIENCE XPEDITION STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32MM) WITH REFERENCE VESSEL DIAMETERS OF >= 2.25 MM TO <= 4.25 MM. IN ADDITION, THE XIENCE XPEDITION STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.  FOR ADDITIONAL INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
P110019|S075|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/02/2015|09/23/2015|15M-3516|10/15/2015|APPR|APPROVAL FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE DEVICES ARE INDICATED FOR THE FOLLOWING:XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM.  THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.25 MM. ADDITIONALLY, THE XIENCE V STENT IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM.  THE XIENCE PRIME STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32 MM) WITH REFERENCE VESSEL DIAMETERS OF >=2.25 MM TO <= 4.25 MM.ADDITIONALLY, THE XIENCE PRIME STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.  XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM.THE XIENCE XPEDITION STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32MM) WITH REFERENCE VESSEL DIAMETERS OF >= 2.25 MM TO <= 4.25 MM. IN ADDITION, THE XIENCE XPEDITION STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.  FOR ADDITIONAL INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
P860004|S221|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|03/02/2015|||OK30|RELOCATION OF AN EXTERNAL SUPPLIERS MANUFACTURING FACILITY AND THE REPLACEMENT OF THE CURRENT LASER MARKING EQUIPMENT.
P080013|S011|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT|NQR|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/02/2015|05/11/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:1) CHANGE THE DEFINITION OF THE MINIMUM NECESSARY FOLLOW-UP FROM 60 TO 45 DAYS FOR THE RETROSPECTIVE CONTROL SUBJECTS ONLY; AND 2) ALLOW ANY NEW STUDY SITES THAT DO NOT HAVE 90 DAY STANDARD OF CARE VISITS TO ENROLL PROSPECTIVE SUBJECTS ONLY (DURASEAL AND/OR CONTROL). THIS WOULD ALLOW NEW SITES TO CONTRIBUTE SUBJECTS PROSPECTIVELY INSIDE THE STUDY WINDOW (60 TO 120 DAYS), BUT EXCLUDE RETROSPECTIVE SUBJECTS THAT WOULD POTENTIALLY HAVE BEEN SEEN OUTSIDE OF THE STUDY WINDOW THUS MAINTAINING CONTROL OVER FOLLOW-UP COMPLIANCE.
P100022|S012|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2015|02/26/2015|||OK30|CHANGE TO THE PUSHER BAND LOCATION ON THE STENT DELIVERY SYSTEM.
P000006|S043|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2015|03/05/2015|||OK30|IMPLEMENTING AN UPDATE TO A DRAWING.
P900033|S043|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2015|03/04/2015|||OK30|QUALIFICATION OF A NEW PRODUCT PACKAGE SEALING EQUIPMENT FOR THE INTEGRA DERMAL REGENERATION TEMPLATE, AT THE PLAINSBORO, NEW JERSEY, INTEGRA MANUFACTURING FACILITY.
P050047|S045|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2015|03/04/2015|||OK30|SCALE-UP OF A GEL COMPOUNDING LINE IN THE JUVEDERM MANUFACTURING PROCESS.
P850064|S028|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR, PATIENT BOX|LSZ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/04/2015|12/17/2015|||APPR|APPROVAL TO UPGRADE THE LIFE PULSE HIGH LIFE PULSE HIGH FREQUENCY VENTILATOR 204 AND PATIENT BOX 213.
P910023|S354|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2015|04/08/2015|||APPR|APPROVAL FOR MERLIN.NET HEART FAILURE WEB APPLICATION V8.5SOFTWARE FOR USE WITH THE DEVICES LISTED.
P980016|S526|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S(DR/VR) ICD, EVERA XT (DR/VR) ICD, MAXIMO II ICD, PROTECTA (XT)ICD,SECURA ICD, VIRTUOUSO II(DR/VR) ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/04/2015|||OK30|ADD ALTERNATIVE ULTRAVIOLET (UV) IRRADIATOR EQUIPMENT IN THE MANUFACTURING PROCESS FOR THE DEVICES.
P980035|S411|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/04/2015|||OK30|ADD ALTERNATIVE ULTRAVIOLET (UV) IRRADIATOR EQUIPMENT IN THE MANUFACTURING PROCESS FOR THE DEVICES.
P090013|S174|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/04/2015|||OK30|ADD ALTERNATIVE ULTRAVIOLET (UV) IRRADIATOR EQUIPMENT IN THE MANUFACTURING PROCESS FOR THE DEVICES.
P010015|S263|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/04/2015|||OK30|ADD ALTERNATIVE ULTRAVIOLET (UV) IRRADIATOR EQUIPMENT IN THE MANUFACTURING PROCESS FOR THE DEVICES.
P010031|S490|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA (CRT-D/QUAD),CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D,PROTECTA XT,VIVA QUAD (S/XT),VIVA (S/XT)||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/04/2015|||OK30|ADD ALTERNATIVE ULTRAVIOLET (UV) IRRADIATOR EQUIPMENT IN THE MANUFACTURING PROCESS FOR THE DEVICES.
P110016|S015|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|FLEXABILITY ABLATION CATHETER|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|02/26/2015|||APPR|APPROVAL FOR AN ADDITIONAL MANUFACTURING INSPECTION STEP.
P950037|S147|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SELOX JT 45 /JT53; ST53/ST60;TILDA R45, R53,R60; SAFIO S53, S60; TILDA JT45,53, TILDA T53,60; DRUG ELUTING PERMANENT RIG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|02/20/2015|||OK30|REPLACE FINISHED STEROID ELUTING LEADS WITH LEAD DUMMIES FOR THE PARTICULATE MATTER TESTING.
P980023|S064|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART SD60/16; SD 65/16; 65/18, 75/18; S60, S65, S75, S DX 65/15, 65/17, T65, TD 65/16, 65/18, VOLTA TA ICR60,65,7|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|02/20/2015|||OK30|REPLACE FINISHED STEROID ELUTING LEADS WITH LEAD DUMMIES FOR THE PARTICULATE MATTER TESTING.
P840001|S293|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/06/2015|||OK30|AUTOMATE INSPECTION OF FINAL DEVICE SEALED TRAY PACKAGE.
P960009|S217|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/06/2015|||OK30|AUTOMATE INSPECTION OF FINAL DEVICE SEALED TRAY PACKAGE.
P860004|S222|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/03/2015|||OK30|UPDATE THE CLEANING PROCESS OF THE PUMP HEAD COMPONENTS.
P970004|S190|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/06/2015|||OK30|AUTOMATE INSPECTION OF FINAL DEVICE SEALED TRAY PACKAGE.
P080025|S086|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|03/06/2015|||OK30|AUTOMATE INSPECTION OF FINAL DEVICE SEALED TRAY PACKAGE.
P030054|S283|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2015|04/08/2015|||APPR|APPROVAL FOR MERLIN.NET HEART FAILURE WEB APPLICATION V8.5SOFTWARE FOR USE WITH THE DEVICES LISTED.
P030035|S132|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2015|04/08/2015|||APPR|APPROVAL FOR MERLIN.NET HEART FAILURE WEB APPLICATION V8.5SOFTWARE FOR USE WITH THE DEVICES LISTED.
P880086|S254|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2015|04/08/2015|||APPR|APPROVAL FOR MERLIN.NET HEART FAILURE WEB APPLICATION V8.5SOFTWARE FOR USE WITH THE DEVICES LISTED.
P070008|S059|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CELERITY 2D 75, 2D 85, 3D75, 3D85, PIOLOT 75,85; COROX OTW 75-UP STEROID, 85-UP, 85-BP, D75-BP|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2015|02/20/2015|||OK30|REPLACE FINISHED STEROID ELUTING LEADS WITH LEAD DUMMIES FOR THE PARTICULATE MATTER TESTING.
P100045|S004|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF SYSTEM|MOM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2015|04/08/2015|||APPR|APPROVAL FOR MERLIN.NET HEART FAILURE WEB APPLICATION V8.5SOFTWARE FOR USE WITH THE DEVICES LISTED.
P110016|S016|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|FLEXABILITY ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|07/02/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH, IN ALAJUELA, COSTA RICA
P120020|S007|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/06/2015|||OK30|ADDITION OF AN ALTERNATE SITE FOR STENT PROCESSING.
P980016|S527|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR, EVERA S VR,EVERA XT DR, EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/01/2015|||OK30|UPDATE THE FINAL VISUAL INSPECTION CRITERIA FOR THE HYBRIDS USED IN THE  DEVICES.
P980035|S412|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPGS, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/01/2015|||OK30|UPDATE THE FINAL VISUAL INSPECTION CRITERIA FOR THE HYBRIDS USED IN THE  DEVICES.
P090013|S175|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/01/2015|||OK30|UPDATE THE FINAL VISUAL INSPECTION CRITERIA FOR THE HYBRIDS USED IN THE  DEVICES.
P010015|S264|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P,VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/01/2015|||OK30|UPDATE THE FINAL VISUAL INSPECTION CRITERIA FOR THE HYBRIDS USED IN THE  DEVICES.
P010031|S491|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CR||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/01/2015|||OK30|UPDATE THE FINAL VISUAL INSPECTION CRITERIA FOR THE HYBRIDS USED IN THE  DEVICES.
P980035|S413|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/03/2015|||OK30|UPDATES TO THE INTEGRATED CIRCUIT TEST SOFTWARE AND TEST PROCESS.
P010031|S492|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA,BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT CR||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/03/2015|||OK30|UPDATES TO THE INTEGRATED CIRCUIT TEST SOFTWARE AND TEST PROCESS.
P960040|S343|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INOGEN, ORIGEN AND DYNAGEN ICDS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/01/2015|||OK30|ALTERNATE SUPPLIER OF THE HV CAPACITOR LIDS FOR THE DEVICES.
P010012|S385|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||INOGEN, ORIGEN AND DYNAGEN CRT-DS||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/01/2015|||OK30|ALTERNATE SUPPLIER OF THE HV CAPACITOR LIDS FOR THE DEVICES.
P980016|S528|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR, EVERA S VR, EVERA XT DR,EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/03/2015|||OK30|UPDATES TO THE INTEGRATED CIRCUIT TEST SOFTWARE AND TEST PROCESS.
P010015|S265|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA, SYNCRA, VIVA CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/03/2015|||OK30|UPDATES TO THE INTEGRATED CIRCUIT TEST SOFTWARE AND TEST PROCESS.
P060006|S065|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/06/2015|||OK30|MODIFY THE TOOLPATH AND SOFTWARE ASSOCIATED WITH THE STENT CUTTING LASERS.
P090003|S038|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTEDSTENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/06/2015|||OK30|MODIFY THE TOOLPATH AND SOFTWARE ASSOCIATED WITH THE STENT CUTTING LASERS.
P110035|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2015|03/06/2015|||OK30|MODIFY THE TOOLPATH AND SOFTWARE ASSOCIATED WITH THE STENT CUTTING LASERS.
P010001|S011|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|03/25/2015|||OK30|ADDITION OF CLEANING EQUIPMENT.
P100026|S030|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|03/06/2015|||OK30|MODIFY THE MANUFACTURING AND INSPECTION PROCESS FOR THE WAND (W-2).
P010031|S493|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA, BRAVA QUAD, VIVA QUAD, VIVA QUAD S, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|03/01/2015|||OK30|CONNECTOR MODULE INSPECTION UPDATES.
P980016|S530|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|03/01/2015|||OK30|CONNECTOR MODULE INSPECTION UPDATES.
P120010|S061|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MiniMed 530G System|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/06/2015|02/22/2016|||APPR|Approval for a change to the shelf height specification for the Enlite Sensor base (part number 6015277-001). The Enlite Sensor base is a subcomponent of Enlite Sensor model MMT-7008, which is a component of the MiniMed 530G System.
P060028|S006|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|03/05/2015|||OK30|CHANGE TO THE ASSIGNED SHELF LIFE OF THE FINAL GEL MIX, IMPLEMENTATION OF NEW EQUIPMENT AND A CHANGE TO THE GEL MIXTURE SAMPLING PROCEDURE.
P980016|S529|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,VR ICD, XT DR ICD,VR ICD, MAXIMO II ICD, PROTECTA ICD,XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|02/23/2015|||OK30|ADD A VAPOR DEGREASER TO THE HYBRID BUILD CLEAN PROCESS.
P980035|S414|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|02/23/2015|||OK30|ADD A VAPOR DEGREASER TO THE HYBRID BUILD CLEAN PROCESS.
P090013|S176|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|02/23/2015|||OK30|ADD A VAPOR DEGREASER TO THE HYBRID BUILD CLEAN PROCESS.
P010015|S266|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|02/23/2015|||OK30|ADD A VAPOR DEGREASER TO THE HYBRID BUILD CLEAN PROCESS.
P010031|S494|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VI||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/06/2015|02/23/2015|||OK30|ADD A VAPOR DEGREASER TO THE HYBRID BUILD CLEAN PROCESS.
P120016|S009|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/11/2015|||OK30|MANUFACTURING OF THE MEMBRANE PRECONDITION SUBASSEMBLY IN A NEW MANUFACTURING FACILITY LOCATED IN GUAYMAS, SONORA MEXICO.
P080030|S013|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/09/2015|08/07/2015|||APPR|APPROVAL TO UPDATE YOUR LABELING TO INCLUDE THE RESULTS OF YOUR POST-APPROVAL STUDY (PAS) FOR THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM, EXTENDED FOLLOW-UP OF THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) COHORT STUDY.
P060025|S014|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||heart-valve, non-allograft tissue|3F AORTIC BIOPROSTHESIS|LWR|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/09/2015|10/13/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P920015|S148|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/03/2015|||OK30|IMPLEMENT A NEW METHOD TO APPLY ADHESIVE TO SLITS IN THE MODELS.
P130009|S028|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|12/07/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE CLEANING PROCESS FOR SMALL AND LARGE COMPONENTS AT THE DRAPER FACILITY.
P100041|S065|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|12/07/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE CLEANING PROCESS FOR SMALL AND LARGE COMPONENTS AT THE DRAPER FACILITY.
P110021|S052|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|12/07/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE CLEANING PROCESS FOR SMALL AND LARGE COMPONENTS AT THE DRAPER FACILITY.
P010029|S022|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/12/2015|||OK30|PROPOSED SCALE-UP OF MANUFACTURING PROCESSES TO INCREASE PRODUCT YIELD PER LOT FOR THE EUFLEXXA PRODUCT.
P010015|S267|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD AND ATTAIN OTW LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P030036|S077|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P060039|S066|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P080006|S076|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD AND ATTAIN QUADRIPOLAR LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P090013|S177|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P830061|S118|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P850089|S113|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD,CAPSURE Z NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P890003|S327|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2 LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P920015|S149|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATRO LEAD,SUBCUTANEOUS LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P930039|S125|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD,SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P980050|S098|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2015|03/02/2015|||OK30|ADDITION OF A NEW SHRINK WRAP MACHINE TO THE FINAL PACKAGING LINE.
P000008|S033|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|01/29/2015|05/27/2015|||APPR|APPROVAL FOR A POST-APPROVAL STUDY PROTOCOL.
P910023|S355|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|08/27/2015|||APPR|APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3 MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.
P030054|S284|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|08/27/2015|||APPR|APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.
P030035|S133|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER / FRONTIER II / ANTHEM FAMILY OF CRT-P'S|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|08/27/2015|||APPR|APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.
P970013|S064|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|08/27/2015|||APPR|APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.
P880086|S255|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY / VICTORY /ZEPHYR ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|08/27/2015|||APPR|APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3 MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.
P880006|S093|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|08/27/2015|||APPR|APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3 MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.
P020050|S020|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2015|03/31/2015|||APPR|APPROVAL FOR A FIRMWARE FIX.
P030008|S018|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2015|03/31/2015|||APPR|APPROVAL FOR A FIRMWARE FIX.
P080030|S014|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/11/2015|03/24/2015|||APPR|APPROVAL TO UPDATE THE MAGNETIC RESONANCE IMAGING (MRI) INFORMATION IN THE INSTRUCTION FOR USE AND PATIENT ID CARD OF THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM.
P030017|S214|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2015|03/13/2015|||OK30|UPGRADE TO NEW BATTERY TEST EQUIPMENT.
P950029|S102|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|09/16/2015|||APPR|APPROVAL FOR THE SMARTVIEW HOTSPOT REMOTE MONITORING SYSTEM.
P060027|S072|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SMARTVIEW REMOTE MONITORING SYSTEM|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|09/16/2015|||APPR|APPROVAL FOR THE SMARTVIEW HOTSPOT REMOTE MONITORING SYSTEM.
P980049|S105|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|SMARTVIEW REMOTE MONITORING SYSTEM|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/11/2015|09/16/2015|||APPR|APPROVAL FOR THE SMARTVIEW HOTSPOT REMOTE MONITORING SYSTEM.
P100027|S021|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2015|03/19/2015|||OK30|CHANGE IN THE METRIC USED TO MONITOR THE MANUFACTURING PROCESS OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL. IN ADDITION, THE METRIC CHANGE, AN INCREASE IN THE NUMBER OF SLIDES TESTED FOR FINAL ACCEPTANCE TESTING, AS WELL AS AN EXPANSION OF THAT FINAL ACCEPTANCE TESTING TO INCLUDE GASTRIC TISSUE, WILL BE IMPLEMENTED.
P040024|S079|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE/RESTYLANE-L/ PERLANE/ PERLANE-L , RESTYLANE SILK(INJECTABLE GELS)|LMH|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/2015|01/26/2016|||APPR|APPROVAL FOR A NEW SYRINGE CONTAINER CLOSURE SYSTEM FOR RESTYLANE®, RESTYLANE-L®, PERLANE®, PERLANE-L® AND RESTYLANE® SILK.
P930014|S078|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2015|03/19/2015|||OK30|TWO ALTERNATE POLYPROPYLENE RESINS, BASELL PD702 AND TOTAL M3766.
P040020|S056|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR INTRAOCULAR LENSES|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2015|03/19/2015|||OK30|TWO ALTERNATE POLYPROPYLENE RESINS, BASELL PD702 AND TOTAL M3766.
P110011|S009|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2015|09/09/2015|||APPR|APPROVAL FOR A CHANGE TO IN-PROCESS TESTING PROCEDURES.
P000006|S044|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2015|02/23/2015|||APPR|APPROVAL TO IMPLEMENT AN ADDITIONAL IN-PROCESS TEST DURING THE MANUFACTURING OF THE TITAN TOUCH PUMP.
P970051|S128|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2015|03/13/2015|||OK30|ADDITION OF THE HELIUM BOMBING, AND REMOVAL OF GROSS LEAK TEST FOR THE MAGNET ASSEMBLY.
P130016|S011|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/13/2015|03/13/2015|||OK30|ADDITION OF THE HELIUM BOMBING, AND REMOVAL OF GROSS LEAK TEST FOR THE MAGNET ASSEMBLY.
P970029|S027|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|PEARL 8.0 HANDPIECE|MNO|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/13/2015|04/03/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: THE SPONSOR HAS REQUESTED TO PLACE THEIR PAS ON HOLD.
P950037|S148|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pacemaker/icd/crt non-implanted components|ACTROS/AXIOS DR/SR/SLR/D/S, BA03 DDDR, CYLOS DR/DR-T/VR, DROMOS DR/SR/SL, KAIROS DR/SR/SL/D/S, PHILOS DR/D|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/13/2015|04/09/2015|||APPR|APPROVAL FOR UPDATES TO YOUR ICS 3000/RENAMIC PROGRAMMERSOFTWARE (1501.U).
P000009|S061|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/13/2015|04/09/2015|||APPR|APPROVAL FOR UPDATES TO YOUR ICS 3000/RENAMIC PROGRAMMERSOFTWARE (1501.U).
P050023|S083|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-T/VR-T DX, & VARIOUS LUMAX ICDS; IFORIA/ILESTO/IPERIA/ITREVIA 5/7 HF-T|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/13/2015|04/09/2015|||APPR|APPROVAL FOR UPDATES TO YOUR ICS 3000/RENAMIC PROGRAMMERSOFTWARE (1501.U).
P070008|S060|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STATOS LV/LV-T, EVIA/ENTOVIS HF/HF-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/13/2015|04/09/2015|||APPR|APPROVAL FOR UPDATES TO YOUR ICS 3000/RENAMIC PROGRAMMERSOFTWARE (1501.U).
P120022|S010|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN EGFR RGQ PCR KIT|OWD|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/2015|08/06/2015|||APPR|APPROVAL FOR THE CHANGE IN MANUFACTURING OF A CRITICAL REAGENT (TAQ POLYMERASE)AND THE CONVERSION OF A MANUAL REAGENT FILL PROCESS TO ONE THAT IS AUTOMATED.
P110027|S008|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN KRAS RGQ PCR KIT|OWD|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/2015|08/06/2015|||APPR|APPROVAL FOR THE CHANGE IN MANUFACTURING OF A CRITICAL REAGENT (TAQ POLYMERASE) AND THE CONVERSION OF A MANUAL REAGENT FILL PROCESS TO ONE THAT IS AUTOMATED.
P850064|S029|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|ADDITION OF AN AUTOMATED WIRE STRIPPER.
P990040|S020|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUEFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM|KGG|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2015|03/24/2015|||APPR|APPROVAL FOR CHANGING THE SUPPLIER AND THE MATERIAL FOR THE N-BUTYL CYANOACRYLATE (N-BCA) CAPS.
P040027|S040|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|USE OF AN EPTFE BONDING FILM MADE FROM AN ALTERNATE RESIN AND THE USE OF FEP FILM FROM AN ALTERNATE SUPPLIER.
P840001|S294|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL  AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|CHANGE THE BRAIDED LEAD BODY CUTTING PROCESS.
P960058|S115|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/18/2015|05/19/2015|||APPR|APPROVAL FOR A NEW CONFIGURATION TO THE HIFOCUS MID-SCALA (HFMS) ELECTRODEINSTRUMENT KIT, NAMELY A STANDALONE HFMS ELECTRODE INSERTION TOOL (MODEL NUMBER CI-4207).
P980022|S178|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2015|05/19/2015|||APPR|APPROVAL FOR A CHANGE TO THE SHELF HEIGHT DIMENSIONS OF THE WATERTIGHT TESTER (MMT-7726), A COMPONENT OF THE MINILINK REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM AND THE MINIMED 530G SYSTEM.
P990004|S026|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE USP|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|CHANGES TO THE SAMPLING FREQUENCY USED FOR THE IN-PROCESS VISUAL INSPECTION, BARCODE SCANNING AND VACUUM TESTING PERFORMED ON THE SURGIFOAM PACKAGING.
P060022|S021|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|AUTOMATED SECONDARY PACKAGING SYSTEM.
P980016|S531|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD,|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|CHANGES TO THE CAPACITOR MANUFACTURING LINE
P010031|S495|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA , BRAVA QUAD/S , VIVA QUAD S/XT ,, VIVA S/XT CRT-D'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|CHANGES TO THE CAPACITOR MANUFACTURING LINE
P850010|S058|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|ADDITION OF A NEW ETHANOL SQUEEZE DEVICE TO REPLACE THE HAND SQUEEZING PROCESS CURRENTLY USED DURING MANUFACTURE OF THE DEVICES.
P070026|S028|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX (R) CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|ADD 2D BARCODE LASER ETCHING MANUFACTURING PROCESS.
P130005|S007|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|11/30/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARDIOVASCULAR SYSTEMS INC., IN ST. PAUL, MINNESOTA.
P120010|S062|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/18/2015|05/19/2015|||APPR|APPROVAL FOR A CHANGE TO THE SHELF HEIGHT DIMENSIONS OF THE WATERTIGHT TESTER (MMT-7726), A COMPONENT OF THE MINILINK REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM AND THE MINIMED 530G SYSTEM.
P990004|S027|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE USP|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|OPTIMIZATION OF A POUCH PACKAGING MACHINE USED FOR THE MANUFACTURE OF SURGIFOAM ABSORBABLE GELATIN SPONGE.
P960009|S218|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|ADDITION OF AN ALTERNATE MATERIAL AND COMPONENT SUPPLIER.
P050006|S046|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/19/2015|||OK30|MODIFICATION TO THE PVA SPECIFICATION.
P810006|S059|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT/ INSTAT ABSORBALE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|ADDITION OF A NEW ETHANOL SQUEEZE DEVICE TO REPLACE THE HAND SQUEEZING PROCESS CURRENTLY USED DURING MANUFACTURE OF THE DEVICES.
P100041|S066|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|ADD A CHAMBER TO THE ETHYLENE OXIDE STERILIZATION PROCESS AT THE STERIGENICS FACILITY (SALT LAKE CITY, UTAH).
P110021|S053|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|ADD A CHAMBER TO THE ETHYLENE OXIDE STERILIZATION PROCESS AT THE STERIGENICS FACILITY (SALT LAKE CITY, UTAH).
P130009|S029|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|ADD A CHAMBER TO THE ETHYLENE OXIDE STERILIZATION PROCESS AT THE STERIGENICS FACILITY (SALT LAKE CITY, UTAH).
P950029|S103|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|ADDITION OF AUTOMATED OPTICAL INSPECTION (AOI) IN MANUFACTURING ASSEMBLY LINE FOR THE DEVICES.
P980049|S106|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL102), INTENSIA VR ICD, INTENSIA DR|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|ADDITION OF AUTOMATED OPTICAL INSPECTION (AOI) IN MANUFACTURING ASSEMBLY LINE FOR THE DEVICES.
P060027|S073|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 (ZL 102), INTENSIA CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|ADDITION OF AUTOMATED OPTICAL INSPECTION (AOI) IN MANUFACTURING ASSEMBLY LINE FOR THE DEVICES.
P010031|S496|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/11/2015|||OK30|ADD NEW EQUIPMENT FOR THE FILL HOLE SEAL (FHS) AND BUTTON (BTN) WELDS WHICH ARE USED TO HERMETICALLY SEAL THE ELECTROLYTE FILL PORT.
P980016|S532|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/11/2015|||OK30|ADD NEW EQUIPMENT FOR THE FILL HOLE SEAL (FHS) AND BUTTON (BTN) WELDS WHICH ARE USED TO HERMETICALLY SEAL THE ELECTROLYTE FILL PORT.
P110004|S011|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX|MAF|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2015|03/17/2015|||APPR|APPROVAL FOR A PATIENT IMPLANT CARD.
P090016|S014|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2015|03/25/2015|||OK30|CHANGES TO THE INCOMING INSPECTION PROCEDURE FOR THE BELOTERO BALANCE DERMAL FILLER.
P860003|S078|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEXPHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2015|03/19/2015|||OK30|MANUFACTURING PROCESS CHANGE FOR A COMPONENT OF THE THERAKOS CELLEX PHOTOPHERESIS SYSTEMS.
P980049|S107|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM (VR/DR) 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF (VR/DR) 9750,INTENSIA (VR 124/DR 154)|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2015|03/13/2015|||OK30|USE OF ADDITIONAL ELECTRICAL WELDING EQUIPMENT IN THE MANUFACTURING LABORATORY.
P060027|S074|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM RF CRT-D9750 (ZL102), INTENSIA CRT-D 174|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2015|03/13/2015|||OK30|USE OF ADDITIONAL ELECTRICAL WELDING EQUIPMENT IN THE MANUFACTURING LABORATORY.
P010031|S497|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS FOR THE CAPACITOR CASE SUBASSEMBLY USED IN THE DEVICES.
P980016|S533|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/17/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS FOR THE CAPACITOR CASE SUBASSEMBLY USED IN THE DEVICES.
P110007|S006|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON ENDOCOAT OPTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|04/02/2015|||OK30|MODIFY THE QUALITY CONTROL TEST METHODS AND/OR ACCEPTANCE CRITERIA ASSOCIATED WITH THE ABBOTT MEDICAL OPTICS (AMO) SODIUM HAYALURONATE (NAHY) SPECIFICATIONS.
P120016|S010|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|03/20/2015|||OK30|TRANSFER OF THE PUSH ROD SUBASSEMBLY TO A NEW MANUFACTURING LOCATION.
P810031|S052|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2015|04/02/2015|||OK30|MODIFY THE QUALITY CONTROL TEST METHODS AND/OR ACCEPTANCE CRITERIA ASSOCIATED WITH THE ABBOTT MEDICAL OPTICS (AMO) SODIUM HAYALURONATE (NAHY) SPECIFICATIONS.
P110010|S102|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2015|02/24/2016|||APPR|Approval for the change to the cleaning process for equipment used during drug-eluting stent manufacturing.
P030053|S024|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/17/2015|||OK30|CHANGE TO AUTOMATE THE GEL MIX MATERIAL SAMPLING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P980040|S059|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR 1-PIECE INTRAOCULAR LENS (IOL)|HQL|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/20/2015|05/15/2015|||APPR|APPROVAL FOR LABELING CHANGES FOR THE SENSAR ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AAB00.
P060028|S007|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/17/2015|||OK30|CHANGE TO AUTOMATE THE GEL MIX MATERIAL SAMPLING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P060028|S008|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/19/2015|||OK30|CHANGES IN THE PRODUCTION OF MEMORYSHAPE BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY. THE CHANGES INCLUDE EXPANDING THE GOWNING AREA, INCREASING THE NUMBER OF DRYING RODS IN THE SHELL DRYING OVEN AND UPDATING THE BOWL FILL PROCEDURE.
P950005|S056|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER DS BI-DIRECTIONAL CATHETER, CELSIUS CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/19/2015|||OK30|ADDITIONAL QUALIFIED SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P990025|S044|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER NAV BI-DIRECTIONAL CATHETER AND NAVISTAR CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/19/2015|||OK30|ADDITIONAL QUALIFIED SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P010068|S045|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EZ STEER NAV DS BI-DIRECTIONAL CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/19/2015|||OK30|ADDITIONAL QUALIFIED SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P030031|S066|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER AND THERMOCOOL CATHETER FAMILIES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/19/2015|||OK30|ADDITIONAL QUALIFIED SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P040036|S049|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMART TOUCH BI-DIRECTIONAL CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/19/2015|||OK30|ADDITIONAL QUALIFIED SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES.
P980006|S024|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PURE VISION (BALAFILCON A)VISIBILITY TINTED CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/23/2015|||OK30|NEW OPTICAL COMPARATOR VISION SYSTEM.
P990025|S045|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER NAV|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/23/2015|||OK30|ADDING A SECOND SUPPLIER FOR THE 1MM SENSOR COMPONENT USED IN THE CATHETER FAMILIES.
P010068|S046|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EZ STEER NAV DS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/23/2015|||OK30|ADDING A SECOND SUPPLIER FOR THE 1MM SENSOR COMPONENT USED IN THE CATHETER FAMILIES.
P030031|S067|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/23/2015|||OK30|ADDING A SECOND SUPPLIER FOR THE 1MM SENSOR COMPONENT USED IN THE CATHETER FAMILIES.
P040036|S050|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ STEER THERMOCOOL NAV|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/20/2015|03/23/2015|||OK30|ADDING A SECOND SUPPLIER FOR THE 1MM SENSOR COMPONENT USED IN THE CATHETER FAMILIES.
P030017|S215|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/25/2015|||OK30|ADD A SUPPLIER OF PRINTED CIRCUIT BOARD COMPONENTS.
N970003|S171|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO AND VITALIO PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/23/2015|||OK30|MANUFACTURE THE BATTERY FEEDTHRU SUBASSEMBLY USED IN THE DEVICES AT THE ST. PAUL FACILITY..
P060006|S066|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/17/2015|||OK30|SOFTWARE UPDATES TO THE FULL BODY STRETCHER OF BALLOON COMPONENTS DURING THE MANUFACTURING PROCESS.
P030005|S117|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE AND INTUA CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/23/2015|||OK30|MANUFACTURE THE BATTERY FEEDTHRU SUBASSEMBLY USED IN THE DEVICES AT THE ST. PAUL FACILITY..
P100023|S114|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/17/2015|||OK30|SOFTWARE UPDATES TO THE FULL BODY STRETCHER OF BALLOON COMPONENTS DURING THE MANUFACTURING PROCESS.
P110010|S103|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/17/2015|||OK30|SOFTWARE UPDATES TO THE FULL BODY STRETCHER OF BALLOON COMPONENTS DURING THE MANUFACTURING PROCESS.
P060040|S039|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/24/2015|||OK30|ALTERNATE METHOD FOR THE MOLDING PROCESS OF THE HEARTMATE II PERCUTANEOUS CABLES.
P130030|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/17/2015|||OK30|SOFTWARE UPDATES TO THE FULL BODY STRETCHER OF BALLOON COMPONENTS DURING THE MANUFACTURING PROCESS.
P050019|S021|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT ENDOPROSTHESIS|NIM|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/23/2015|05/15/2015|||APPR|APPROVAL FOR LABELING CHANGES RELATED TO THE MR COMPATIBILITY OF THE DEVICE.
P100047|S055|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2015|03/25/2015|||APPR|APPROVAL FOR AN ADDITIONAL INDEPENDENT INSPECTION AT FINAL PACKAGING.
P050047|S046|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/26/2015|||OK30|EXPANSION OF THE PRINGY II MANUFACTURING FACILITY AND ASSOCIATED MINOR CHANGES TO THE UTILITIES DISTRIBUTION SYSTEM AT THE FACILITY, TO ACCOMMODATE THE ADDEDMANUFACTURING SPACE.
P110033|S013|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/26/2015|||OK30|EXPANSION OF THE PRINGY II MANUFACTURING FACILITY AND ASSOCIATED MINOR CHANGES TO THE UTILITIES DISTRIBUTION SYSTEM AT THE FACILITY, TO ACCOMMODATE THE ADDEDMANUFACTURING SPACE.
P840062|S044|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/26/2015|||OK30|ENHANCED COMPRESSOR CONFIGURATION.
P980007|S039|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA (LN 6C07)|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/26/2015|||OK30|CHANGES IN THE PRECURSOR CODE FOR BOVINE SERUM AND HUMAN PROSTATE SPECIFIC ANTIGEN WITH EQUIVALENT MATERIALS FOR THE MANUFACTURE OF THE ARCHITECT FREE PSA AND TOTAL PSA CALIBRATORS, CONTROLS, AND SECONDARY CALIBRATORS.
P850010|S059|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/26/2015|||OK30|ENHANCED COMPRESSOR CONFIGURATION.
P810006|S060|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/26/2015|||OK30|ENHANCED COMPRESSOR CONFIGURATION.
P910007|S048|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA (LN 6C06)|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/26/2015|||OK30|CHANGES IN THE PRECURSOR CODE FOR BOVINE SERUM AND HUMAN PROSTATE SPECIFIC ANTIGEN WITH EQUIVALENT MATERIALS FOR THE MANUFACTURE OF THE ARCHITECT FREE PSA AND TOTAL PSA CALIBRATORS, CONTROLS, AND SECONDARY CALIBRATORS.
P110028|S015|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/19/2015|||OK30|ALTERNATE RESINS IN THE MANUFACTURING OF THE HANDLE ASSEMBLY FOR THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM.
P010013|S062|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/19/2015|||OK30|ADDITION OF AN IN-HOUSE ASSEMBLY PROCESS FOR THE RADIO FREQUENCY CONTROLLER COMPONENT.
P950029|S104|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/19/2015|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE GLUE USED IN THE DIE ATTACH PROCESS FOR THE HYBRIDS USED IN THE DEVICES.
P980049|S108|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM (VR/DR) 8750, PARADYM RF (VR/DR) 9750(ZL101),PARADYM RF (VR/DR) 9750 (ZL102),INTENSIA (VR/DR)|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/19/2015|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE GLUE USED IN THE DIE ATTACH PROCESS FOR THE HYBRIDS USED IN THE DEVICES.
P060027|S075|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D 9750 (ZL 102) AND INTENSIA CRT-D|NIK|CV|30-Day Notice||N|02/24/2015|03/19/2015|||OK30|ADD AN ALTERNATE SUPPLIER FOR THE GLUE USED IN THE DIE ATTACH PROCESS FOR THE HYBRIDS USED IN THE DEVICES.
P120014|S003|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||Somatic gene mutation detection system|THXID BRAF KIT|OWD|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/2015|05/27/2015|||APPR|APPROVAL FOR USING THE UPDATED ABI 7500 FAST DX OPERATING SYSTEM AND SDS SOFTWARE.
P060037|S034|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2015|03/27/2015|||OK30|INCORPORATING THE CHANGE IN THE DEVICE.
P110001|S012|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, RENAL|RX HERCULINK ELITE RENAL STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2015|03/27/2015|||OK30|ADDITION OF RECEIVING INSPECTION CAPABILITIES AT THE CLONMEL, IRELAND MANUFACTURING SITE AND CONTRACT LABORATORIES.
P050028|S044|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/2015|05/01/2015|||APPR|APPROVAL FOR CHANGES TO THE MAGNETIC GLASS PARTICLE (MGP) REAGENT BOTTLES AND CLOSURES.
P060030|S045|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/2015|05/01/2015|||APPR|APPROVAL FOR CHANGES TO THE MAGNETIC GLASS PARTICLE (MGP) REAGENT BOTTLES AND CLOSURES.
P110037|S019|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/2015|05/01/2015|||APPR|APPROVAL FOR CHANGES TO THE MAGNETIC GLASS PARTICLE (MGP) REAGENT BOTTLES AND CLOSURES.
P100020|S013|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/25/2015|05/01/2015|||APPR|APPROVAL FOR CHANGES TO THE MAGNETIC GLASS PARTICLE (MGP) REAGENT BOTTLES AND CLOSURES.
P110035|S031|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2015|03/27/2015|||OK30|REDUCTION TO THE POST-ELECTROPOLISHING IN-PROCESS MONITORING INSPECTIONS OF THE EPIC STENT COMPONENT.
P810002|S095|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT MECHANICAL HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2015|03/26/2015|||OK30|NEW METHOD FOR LEAFLET SUBSTRATE SLICING.
P050007|S033|ABBOTT VASCULAR DEVICES|3200 LAKESIDE DRIVE||SANTA  CLARA|CA|95054||Device, hemostasis, vascular|STARCLOSE SE VASCULAR CLOSURE SYSTEM|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2015|10/09/2015|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT ABBOTT VASCULAR, INC., IN TIPPERARY IRELAND, AND SYNERGY HEALTH IRELAND LTD., IN OFFALY IRELAND.
P130024|S003|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX DRUG COATED BALLOON|ONU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2015|11/23/2015|||APPR|APPROVAL TO CHANGE THE PARTICULATE SPECIFICATION FOR THE  DEVICE AT LOT RELEASE AND STABILITY TESTING.
P930038|S075|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2015|03/26/2015|||OK30|ALTERNATE DOSE AUDIT STERILITY TESTING VENDOR.
P120016|S011|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2015|03/26/2015|||OK30|TRANSFER OF THE SLEEVE WITH GRIP SUBASSEMBLY TO A NEW MANUFACTURING LOCATION.
P120005|S033|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/25/2015|08/19/2015|||APPR|APPROVAL FOR CHANGES TO THE DEXCOM TRANSMITTER AND RECEIVER AND THE ADDITION OF THE DEXCOM G5 MOBILE APP, TO ENABLE THE TRANSMISSION OF CGM DATA TO THE RECEIVER AND/OR COMPATIBLE APPLE MOBILE DEVICES, AND TO ALLOW ENTRY OF SYSTEM CALIBRATION INFORMATION DIRECTLY FROM COMPATIBLE APPLE MOBILE DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED AS FOLLOWS:THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING SYSTEM INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 2 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G5 MOBILE SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G5 MOBILE SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G5 MOBILE SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P020012|S011|SUNEVA MEDICAL, INC.|5879 PACIFIC CENTER BLVD.||SAN DIEGO|CA|92121||Implant, dermal, for aesthetic use|BELLAFILL PMMA COLLAGEN DERMAL FILLER|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/24/2015|08/07/2015|||APPR|APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT DESCRIBED THE RESULTS OF YOUR 5-YEAR POST-APPROVAL STUDY (P521-01).
P120010|S063|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2015|03/23/2015|||OK30|MODIFICATION TO THE LASER CUTTING PARAMETERS FOR THE POTOMAC LASERSYSTEM USED DURING THE ENLITE SENSOR MANUFACTURING PROCESS IN ORDER TO QUALIFY IT FOR USE WITH THE 48-UP SENSOR CONFIGURATION. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P100047|S056|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2015|03/25/2015|||OK30|ADD AN ALTERNATE SECOND TIER SUPPLIER AND ADD A VELOUR LENGTH TRIMMING PROCESS FOR THE HEARTWARE VENTRICULAR ASSIST SYSTEM.
P100021|S045|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM, ENDURANT (II/IIS) STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2015|03/25/2015|||APPR|APPROVAL FOR THE ADDITION OF A MANUFACTURING AID TO BE USED DURING THE THUMBWHEEL ASSEMBLY PROCESS.
P130019|S001|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/26/2015|06/02/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P090013|S178|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2015|03/11/2015|||OK30|UPDATES TO PROCEDURES FOR TORQUE TESTING AT FINAL FUNCTIONAL INSPECTION.
P930039|S126|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2015|03/11/2015|||OK30|UPDATES TO PROCEDURES FOR TORQUE TESTING AT FINAL FUNCTIONAL INSPECTION.
P010030|S060|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/27/2015|||OK30|EXPANSION OF AN ELECTRICAL TEST PROCEDURE TO COVER ADDITIONAL COMPONENTS, IMPLEMENTATION OF A NEW WORK INSTRUCTION, AND ADDITION OF AN INDEPENDENT VISUAL VERIFICATION STEP.
N970012|S105|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS (IPP)|JCW|GU|135 Review Track For 30-Day Notice||N|02/27/2015|02/04/2016|||APPR|Approval for the implementation of a replacement injection mold, a contract molding service supplier change and a change to the outgassing process related to the collet component of the three devices.
P000053|S056|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM (AUS)|EZY|GU|135 Review Track For 30-Day Notice||N|02/27/2015|02/04/2016|||APPR|Approval for the implementation of a replacement injection mold, a contract molding service supplier change and a change to the outgassing process related to the collet component of the three devices.
P010020|S029|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS)|MIP|GU|135 Review Track For 30-Day Notice||N|02/27/2015|02/04/2016|||APPR|Approval for the implementation of a replacement injection mold, a contract molding service supplier change and a change to the outgassing process related to the collet component of the three devices.
P110006|S005|U-SYSTEMS, INC.|9900 WEST INNOVATIVE DRIVE|MAIL STOP RP2138|WAUWATOSA|WI|53226||Automated breast ultrasound|INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM|PAA|RA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/27/2015|04/13/2015|||APPR|APPROVAL FOR A CHANGE IN APPLICATIONS TRAINING PROGRAM FOR THE INVENIA ABUS AUTOMATED BREAST ULTRASOUND SYSTEM. TWO ADDITIONAL TRAINING PROGRAMS WERE PROPOSED. THE FIRST ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR ONE TECHNOLOGIST/SCAN OPERATOR, EQUIVALENT TO THE PREVIOUSLY-APPROVED THREE-DAY PROGRAM FOR THREE TECHNOLOGISTS/SCAN OPERATORS. THE SECOND ADDITION CONSISTS OF A ONE-DAY TRAINING PROGRAM FOR A DESIGNATED SITEOPERATIONS SPECIALIST WHO IS EXPERIENCED IN INVENIA ABUS BREAST EXAMS, AND IS QUALIFIED FOR THE TRAINING ACCORDING TO A SET OF SPECIFIED REQUIREMENTS OUTLINED BY THE SPONSOR.
P960009|S220|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2015|05/11/2015|||APPR|APPROVAL FOR MATERIAL CHANGES TO TWO NON-IMPLANTABLE SCREENING CABLES (THE ALLIGATOR CLIP SCREENING CABLE ACCESSORY KIT AND THE TWIST LOCK SCREENING CABLE ACCESSORY KIT) TO COMPLY WITH THE EUROPEAN UNION RESTRICTION OF HAZARDOUS SUBSTANCES II DIRECTIVE 2011/65/EU.
P000037|S039|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/26/2015|||OK30|ADDITIONAL X-RAY MACHINE.
P970004|S192|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/26/2015|||OK30|MANUFACTURING CHANGE AFFECTING THE COMPONENT OF AN IMPLANTABLE NEUROSTIMULATOR (INS) USED FOR THE MEDTRONIC NEUROMODULATION SACRAL NERVE STIMULATION (SNS) THERAPIES.
P080025|S087|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/26/2015|||OK30|MANUFACTURING CHANGE AFFECTING THE COMPONENT OF AN IMPLANTABLE NEUROSTIMULATOR (INS) USED FOR THE MEDTRONIC NEUROMODULATION SACRAL NERVE STIMULATION (SNS) THERAPIES.
P130019|S002|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|02/27/2015|07/24/2015|||APPR|APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
P030017|S216|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2015|05/27/2015|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE ENTRADA NEEDLE TO BE USED WITH THE SCS SYSTEMS; SPECIFICALLY, REQUESTING APPROVAL FOR THE ADDITION OF A STYLET CAP COVER TO THE NEEDLE DESIGN.
P130026|S002|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/26/2015|||APPR|APPROVAL FOR CHANGES TO THE MANUFACTURING PROCESS AND AN ADDITIONAL INSPECTION ASSOCIATED WITH IRRIGATION TUBING
P840001|S295|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/27/2015|||OK30|TRANSFER OF INCOMING INSPECTION ACTIVITIES FOR A NUMBER OF COMPONENTS.
P860004|S223|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/27/2015|||OK30|TRANSFER OF INCOMING INSPECTION ACTIVITIES FOR A NUMBER OF COMPONENTS.
P960009|S221|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/27/2015|||OK30|TRANSFER OF INCOMING INSPECTION ACTIVITIES FOR A NUMBER OF COMPONENTS.
P970004|S193|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/27/2015|||OK30|TRANSFER OF INCOMING INSPECTION ACTIVITIES FOR A NUMBER OF COMPONENTS.
P080025|S088|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/27/2015|03/27/2015|||OK30|TRANSFER OF INCOMING INSPECTION ACTIVITIES FOR A NUMBER OF COMPONENTS.
P020050|S021|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2015|06/02/2015|||APPR|APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028) THE DEVICES, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAMES WAVELIGHT® EX500 EXCIMER LASER SYSTEM - EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028).
P030008|S019|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|02/27/2015|06/02/2015|||APPR|APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028) THE DEVICES, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAMES WAVELIGHT® EX500 EXCIMER LASER SYSTEM - EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028).
P930021|S014|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|STRAUMANN EMDOGAIN|NQA|DE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2015|08/26/2015|||APPR|APPROVAL FOR ADDING THE USE OF BIPHASIC CALCIUM PHOSPHATE (HAIJ3-TCP) BONE GRAFT MATERIALS WITH STRAUMANN EMDOGAIN, ADDING THE USE OF COLLAGEN AND OTHER GRAFT MATERIALS WITH STRAUMANN EMDOGAIN AND CHANGING THE NAME OF A CONTRACT MANUFACTURER, IN NAME ONLY, FROM SVERIGE, SCAN AB TO HKSCAN SWEDEN AB.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STRAUMANN EMDOGAIN AND IS INDICATED FOR USE AS AN ADJUNCT TO PERIODONTAL SURGERY AS A TOPICAL APPLICATION ONTO EXPOSED ROOT SURFACES. EMDOGAIN IS INDICATED FOR THE TREATMENT OF THE FOLLOWING CONDITIONS:1) INTRABONY DEFECTS DUE TO MODERATE OR SEVERE PERIODONTITIS;2) MANDIBULAR DEGREE II FURCATIONS WITH MINIMAL INTERPROXIMAL BONE LOSS; 3) GINGIVAL RECESSION DEFECTS IN CONJUNCTION WITH SURGICAL COVERAGE PROCEDURES SUCH ASTHE CORONALLY ADVANCED FLAP TECHNIQUE; AND4) EMDOGAIN IS ALSO INDICATED FOR USE IN A MINIMALLY INVASIVE SURGICAL TECHNIQUE IN ESTHETIC ZONES TO OPTIMIZE TISSUE HEIGHT FOR INTRABONY DEFECTS ONLY.  IN CASES OF WIDE DEFECTS OR WHERE SOFT TISSUE SUPPORT IS DESIRED, STRAUMANN EMDOGAIN CAN BE USED IN CONJUNCTION WITH A BONE GRAFT MATERIAL. FOR FURTHER INFORMATION ON THE USE OF EMDOGAIN WITH BONE GRAFT MATERIALS, PLEASE REFER TO, FOR STRAUMANN EMDOGAIN IN CONJUNCTION WITH BONE GRAFT MATERIAL IN WIDE DEFECTS IN THE CLINICAL PROCEDURE SECTION OF THE DRAFT INSTRUCTIONS.
P030005|S118|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE, INTUA CRT PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|03/27/2015|||OK30|ADDITION OF A DEBURRING OPERATION AND ADDITIONAL MONITORING DURING THE MANUFACTURING OF CASE HALVES FOR THE DEVICES.
N970003|S172|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO, FORMIO PGS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|03/27/2015|||OK30|ADDITION OF A DEBURRING OPERATION AND ADDITIONAL MONITORING DURING THE MANUFACTURING OF CASE HALVES FOR THE DEVICES.
P130024|S004|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX DRUG COATED BALLOON (DCB)|ONU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/02/2015|04/23/2015|||APPR|APPROVAL FOR THE ADDITION OF MARKERS ON THE PROXIMAL CATHETER SHAFT OF THE 40¿100 MM LUTONIX DRUG COATED BALLOON.
P900009|S039|BIOVENTUS LLC|4721 EMPEROR BLVD SUITE 100||DURHAM|NC|27703||Stimulator, ultrasound and muscle, for use other than applying therapeutic deep|EXOGEN ULTRASOUND BONE HEALING SYSTEM|LPQ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|04/22/2015|||OK30|ALTERNATE SUPPLIER.
P900033|S044|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|04/01/2015|||OK30|QUALIFICATION OF THE YOKOGAWA PAPERLESS CHART RECORDING SYSTEM AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
P810006|S061|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT/INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|04/01/2015|||OK30|QUALIFICATION OF THE YOKOGAWA PAPERLESS CHART RECORDING SYSTEM AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
P850010|S060|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT/ HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|04/01/2015|||OK30|QUALIFICATION OF THE YOKOGAWA PAPERLESS CHART RECORDING SYSTEM AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
P020004|S111|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|03/31/2015|||OK30|USE FILM MATERIALS MANUFACTURED BY GORE¿S APPROVED SUPPLIER ON ANALTERNATING MANUFACTURING LINE FOR GORE TAG ENDOPROSTHESIS AND THE GORE EXCLUDER  AAA ENDOPROSTHESIS.
P840062|S045|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE/COLLATAPE/COLLAPLUG ABSORBABLE COLL WOUND DRESS|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|04/01/2015|||OK30|QUALIFICATION OF THE YOKOGAWA PAPERLESS CHART RECORDING SYSTEM AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
P040043|S072|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2015|03/31/2015|||OK30|USE FILM MATERIALS MANUFACTURED BY GORE¿S APPROVED SUPPLIER ON ANALTERNATING MANUFACTURING LINE FOR GORE TAG ENDOPROSTHESIS AND THE GORE EXCLUDER  AAA ENDOPROSTHESIS.
P010047|S037|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT AND PROGEL EXTENDED APPLICATOR SPRAY TIP|NBE|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/02/2015|03/16/2015|||APPR|APPROVAL TO EXTEND ENROLLMENT BY 13 MONTHS TO COMPLETE ENROLLMENT IN THE PAS TO THE POST-APPROVAL STUDY PROTOCOL.
P860004|S224|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PROGRAMMABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/02/2015|11/24/2015|||APPR|APPROVAL FOR TWO DESIGN CHANGES: 1) ENCAPSULATION OF MOTOR FEEDTHROUGHS WITH MEDICAL ADHESIVE IN ORDER TO REDUCE SYSTEM FAILURES FROM FEEDTHROUGH SHORTING; AND 2) THE ADDITION OF AN IMPEDANCE REQUIREMENT TO ENSURE ELECTRICAL ISOLATION OF THE MOTOR CIRCUIT.
P010019|S037|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|04/02/2015|||OK30|ALTERNATE LENS WATER CONTENT MEASUREMENT PROCEDURE AT ALCONS BATAM, INDONESIA MANUFACTURING SITE.
P070026|S029|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|03/25/2015|||APPR|ADDING A MANUAL CHECK OF THE INLET RO WATER FLOW INTO TANK 7 TO ENSURE THAT ADDITIONAL ORDERS ARE NOT PROCESSED BY THE SYSTEM WHEN THE FLOW RATE IS BELOW THE 3 GALLON PER MINUTE REQUIREMENT.
P830055|S155|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|03/25/2015|||APPR|ADDING A MANUAL CHECK OF THE INLET RO WATER FLOW INTO TANK 7 TO ENSURE THAT ADDITIONAL ORDERS ARE NOT PROCESSED BY THE SYSTEM WHEN THE FLOW RATE IS BELOW THE 3 GALLON PER MINUTE REQUIREMENT.
P010031|S498|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|03/19/2015|||OK30|MERGING TWO DIFFERENT ELECTRICAL CONNECTOR MONITORING PLANS TO ESTABLISH ONE STANDARD PLAN USED FOR BOTH THE BATTERY AND CAPACITOR ELECTRICAL CONNECTORS.
P980016|S534|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|03/19/2015|||OK30|MERGING TWO DIFFERENT ELECTRICAL CONNECTOR MONITORING PLANS TO ESTABLISH ONE STANDARD PLAN USED FOR BOTH THE BATTERY AND CAPACITOR ELECTRICAL CONNECTORS.
P130008|S006|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATOR|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|04/02/2015|||OK30|NEW POST-STERILIZATION TEST AT THE FIRMS CONTRACT MANUFACTURER.
P970004|S194|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|04/03/2015|||OK30|ADDITION OF A NEW FINAL FUNCTION TESTER OF AN IMPLANTABLE NEUROSTIMULATOR(INS) USED FOR THE MEDTRONIC NEUROMODULATION SACRAL NERVE STIMULATION (SNS) THERAPIES.
P080025|S089|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|04/03/2015|||OK30|ADDITION OF A NEW FINAL FUNCTION TESTER OF AN IMPLANTABLE NEUROSTIMULATOR(INS) USED FOR THE MEDTRONIC NEUROMODULATION SACRAL NERVE STIMULATION (SNS) THERAPIES.
P020045|S066|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CRYOCONSOLE|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2015|04/03/2015|||APPR|APPROVAL FOR INSTALLATION OF FOUR NEW CATHETER RECOGNITION FILES, AS WELL AS LABELING CHANGES TO THE CRYOCONSOLE OPERATORS MANUAL.
P120006|S019|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/2015|05/21/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE OUTER DIAMETERS OF THE COMPRESSIONSLEEVES.
P120014|S004|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||Somatic gene mutation detection system|THXID BRAF KIT|OWD|PA|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|04/01/2015|||APPR|APPROVAL FOR ADDITION OF A QUALITY CONTROL TEST FOR THE THXID¿-BRAF MASTERMIX.
P120016|S012|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2015|03/31/2015|||OK30|TRANSFER OF THE EPOXY BRAID TO SHAFT SUBASSEMBLY TO A NEW MANUFACTURING LOCATION.
P000029|S080|VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|400 SOMERSET CORPORATE BOULEVARD||BRIDGEWATER|NJ|08807||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DEFLUX INJECTABLE GEL|LNM|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/03/2015|02/23/2016|||APPR|Approval for modifications to Deflux labeling to reflect the findings of the post-approval study (PAS).
P050052|S060|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2015|04/03/2015|||OK30|CHANGE IN LOCATION FOR IN-PROCESS AND RELEASE TESTING.
P100042|S005|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2015|04/01/2015|||OK30|SCALE-UP OF A BULK SOLUTION, INCREASE IN THE BULK HOLD TIME, AND QUALIFICATION OF A NEW MANUFACTURING FILLING SYSTEM.
P120007|S004|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV 16 18/45 GENOTYPE ASSAY|OYB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2015|04/01/2015|||OK30|SCALE-UP OF A BULK SOLUTION, INCREASE IN THE BULK HOLD TIME, AND QUALIFICATION OF A NEW MANUFACTURING FILLING SYSTEM.
P060040|S040|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/2015|04/01/2015|||APPR|APPROVAL FOR A REVISION TO THE PATIENT HANDBOOK.
P040003|S015|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE|NRZ|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/04/2015|08/31/2015|||APPR|APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE STATEMENT, PHYSICIAN LABELING, AND PATIENT LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXABLATE MAGNETIC RESONANCE GUIDED FOCUSED ULTRASOUND SYSTEM AND IS INDICATED TO ABLATE UTERINE FIBROID TISSUE IN PRE- OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE AND WHOSE UTERINE SIZE IS LESS THAN 24 WEEKS.
P040027|S041|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2015|04/03/2015|||OK30|CHANGE TO THE WATER ENTRY PRESSURE (WEP) TESTING REQUIREMENT FOR THE GRAFT COMPONENTS OF THE GORE VIATORR TIPS ENDOPROSTHESIS FROM A LOT ACCEPTANCE TEST TO A QUALIFICATION TEST.
N16837|S019|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2015|04/04/2016|||APPR|Approval for the use of new polymers for the button and rod that are used in the primary packaging system for this device.
P860003|S079|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/16/2015|||OK30|UPDATE ON POST STERILIZATION AERATION CYCLE TIMES FOR THE THERAKOS CELLEX  PHOTOPHERESIS SYSTEMS.
P840001|S296|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|04/02/2015|||OK30|ADDITION OF AN ADDITIONAL SUPPLIER FOR THE GOLD PREFORMS AND TO INCORPORATE THE USE OF AN ELECTRONIC TRACKING SYSTEM.
P960009|S222|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|04/02/2015|||OK30|ADDITION OF AN ADDITIONAL SUPPLIER FOR THE GOLD PREFORMS AND TO INCORPORATE THE USE OF AN ELECTRONIC TRACKING SYSTEM.
P960016|S053|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|04/02/2015|||OK30|CHANGE FROM A MANUAL RING BRAZING STATION TO A MECHANIZED RING BRAZING STATION.
P860004|S225|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|04/02/2015|||OK30|ADDITION OF AN ADDITIONAL SUPPLIER FOR THE GOLD PREFORMS AND TO INCORPORATE THE USE OF AN ELECTRONIC TRACKING SYSTEM.
P970004|S195|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|04/02/2015|||OK30|ADDITION OF AN ADDITIONAL SUPPLIER FOR THE GOLD PREFORMS AND TO INCORPORATE THE USE OF AN ELECTRONIC TRACKING SYSTEM.
P010029|S023|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|04/02/2015|||OK30|INCREASE IN THE PURIFICATION CAPACITY OF AN INTERMEDIATE USED IN THE MANUFACTURE OF THE EUFLEXXA PRODUCT.
P080025|S090|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|04/02/2015|||OK30|ADDITION OF AN ADDITIONAL SUPPLIER FOR THE GOLD PREFORMS AND TO INCORPORATE THE USE OF AN ELECTRONIC TRACKING SYSTEM.
P990004|S028|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE, USP|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|02/05/2016|||APPR|approval for a manufacturing site located at SteriPack Medical Poland SP.ZO.O., Poland, for the contract packaging of the SURGIFLO Hemostatic Matrix Device and thesterilizing  site located at Synergy Health Ede BV, Netherlands, for the sterilization of theSURGIFLO Hemostatic
P890003|S328|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODEL 25000 MY CARELINK SMART READER|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2015|05/04/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
P010015|S268|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2015|05/04/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
P010031|S499|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CONSULTA CRT-D,MAXIMO II CRT-D, CONCERTO II CRT-D,CONCERTO CRT-D, PROTECTA AND PROTECTA XT,VIVA XT,VIVA S,BRAVA CRT-DS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2015|05/04/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
P090013|S179|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2015|05/04/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
P980016|S535|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUOSO,SECURA, MAXIMO II ,VIRTUOSO II , PROTECTA XT ,PROTECTA VT,EVERA (XT/S) ,EVERA S AND XT VR AND DR'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2015|05/04/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
P980035|S415|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA,SENSIA IPG,ADVISA (DR/DR MRI) IPGS,ENRHYTHM MRI,ENPULSE (E1/E2) IPG,KAPPA D(700/900) IPG,KAPPA DR(650) IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/06/2015|05/04/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
P950037|S149|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SLX 58/11-BP, SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,SLX 65/11-BP,SLX 65/13-BP,SLX 65/14-BP,SLX 65/15-BP,SL|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|07/17/2015|||APPR|APPROVAL FOR IMPLEMENTATION OF PARAMETRIC RELEASE IN PLACE OF CONVENTIONAL PRODUCT RELEASE IN THE STERILIZATION PROCESS FOR PERMANENT PACEMAKER AND DEFIBRILLATION LEADS.
P980023|S065|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|KAINOX VCS,PROTEGO SD (60/16)(65/16),(65/18)(75/18), PROTEGO TD (65/16)(65/18)(75/18), PROTEGO S (60/65/75)PROTEGO T 65|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|07/17/2015|||APPR|APPROVAL FOR IMPLEMENTATION OF PARAMETRIC RELEASE IN PLACE OF CONVENTIONAL PRODUCT RELEASE IN THE STERILIZATION PROCESS FOR PERMANENT PACEMAKER AND DEFIBRILLATION LEADS.
P050023|S084|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|COROX OTW 75-UP STEROID,COROX OTW 85 UP STEROID|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|07/17/2015|||APPR|APPROVAL FOR IMPLEMENTATION OF PARAMETRIC RELEASE IN PLACE OF CONVENTIONAL PRODUCT RELEASE IN THE STERILIZATION PROCESS FOR PERMANENT PACEMAKER AND DEFIBRILLATION LEADS.
P070008|S061|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/06/2015|07/17/2015|||APPR|APPROVAL FOR IMPLEMENTATION OF PARAMETRIC RELEASE IN PLACE OF CONVENTIONAL PRODUCT RELEASE IN THE STERILIZATION PROCESS FOR PERMANENT PACEMAKER AND DEFIBRILLATION LEADS.
P080012|S025|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/08/2015|||OK30|ADDITION OF AN ALTERNATE O-RING RAW MATERIAL SUPPLIER.
P930031|S054|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT ENDOPROSTHESIS TIPS|MIR|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2015|08/12/2015|||APPR|APPROVAL FOR A CHANGE IN DEVICE LABELING FROM MR SAFE TO MR CONDITIONAL.
P980033|S043|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT VENOUS ENDOPROSTHESIS|MAF|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2015|08/12/2015|||APPR|APPROVAL FOR A CHANGE IN DEVICE LABELING FROM MR SAFE TO MR CONDITIONAL.
P840001|S297|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE AND ITREL SPINAL CORD STIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/08/2015|||OK30|ADDITION OF A SECOND COMPONENT SUPPLIER.
P960009|S223|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/08/2015|||OK30|ADDITION OF A SECOND COMPONENT SUPPLIER.
P000053|S057|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/08/2015|||OK30|ACCEPTANCE OF A CHANGE TO IN-PROCESS MEASUREMENT EQUIPMENT.
P010020|S030|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS)|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/08/2015|||OK30|ACCEPTANCE OF A CHANGE TO IN-PROCESS MEASUREMENT EQUIPMENT.
P110010|S104|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/08/2015|||OK30|ELIMINATION OF BURST, DIAMETER, AND DISTENSION IN-PROCESS MONITORING REQUIREMENTS FROM THE BALLOON COMPONENT MANUFACTURING PROCESS.
P040012|S055|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/02/2015|||OK30|ALTERNATE SUPPLIER FOR THE NOTCHED HYPOTUBE OF THE STENT DELIVERY SYSTEM AND ASSOCIATED CHANGES TO THE INSPECTION AND PROCESS MONITORING FOR THIS COMPONENT.
P050037|S055|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/07/2015|||OK30|ACCEPTANCE OF AN OPTIONAL REPROCESSING STEP IN THE MANUFACTURING PROCESS.
P050052|S061|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, RADIESSE (+)|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/07/2015|||OK30|ACCEPTANCE OF AN OPTIONAL REPROCESSING STEP IN THE MANUFACTURING PROCESS.
P070009|S015|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER,ETHICON ENDO-SURGERY GASTRIC BAND|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2015|04/20/2015|||OK30|ADDITION OF A PACKAGE INSPECTION STEP FOR THE ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER, AND THE ETHICON ENDO-SURGERY GASTRIC BAND SUTURELESS PORT AND APPLIER.
P980022|S179|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM, GUARDIAN REAL TIME SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2015|01/21/2016|||APPR|APPROVAL FOR THE ADDITION OF A NEW LEAK TESTER TO THE MANUFACTURING PROCESS OF THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
P120010|S064|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM, MINILINK REAL-TIME SYSTEM|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2015|01/21/2016|||APPR|APPROVAL FOR THE ADDITION OF A NEW LEAK TESTER TO THE MANUFACTURING PROCESS OF THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
P830055|S156|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|05/26/2015|||OK30|CHANGES TO THE PRODUCT INSPECTION.
P810002|S096|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2015|04/09/2015|||OK30|IMPLEMENTATION OF A NEW SEALING PLATE CONFIGURATION AND A CHANGE TO SEALING PARAMETERS FOR TYVEK PACKAGING.
P100026|S031|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2015|04/08/2015|||OK30|ALTERNATE MANUFACTURING PROCESS FOR THE LEAD CONTACTS AND LEAD ELECTRODES.
P030017|S217|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track||N|03/11/2015|07/30/2015|||APPR|APPROVAL FOR A LINE EXTENSION OF PRECISION® SYSTEM TO ADD PRECISION NOVI COMPONENTS.
P120002|S007|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|CORDIS S.M.A.R.T.AND S.M.A.R.T.CONTROL VASCULAR STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/11/2015|05/09/2016|||APPR|Approval for updated labeling to include the post-approval study results.
P970003|S177|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM PROGRAMMING SOFTWARE|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|04/10/2015|||OK30|ADDITIONAL INSPECTION STEP.
P080006|S077|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|04/02/2015|||OK30|UPDATE THE PULL TEST CONTROL LIMITS AND SAMPLING SIZE USED TO MONITOR SPECIAL MANUFACTURING PROCESS IN LEADS MANUFACTURING.
P920047|S077|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II /BLAZER II HTD,BLAZER PRIME (XP/HTD) ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|03/24/2015|||OK30|NEW TRACEABILITY AND TRACKING SYSTEM AT THE HEREDIA, COSTA RICA LOCATION.
P920015|S150|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|04/02/2015|||OK30|UPDATE THE PULL TEST CONTROL LIMITS AND SAMPLING SIZE USED TO MONITOR SPECIAL MANUFACTURING PROCESS IN LEADS MANUFACTURING.
P020025|S068|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP ABLATION CATHETERS, INTELLATIP MIFI XP ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES ASSOICATED WITH CARDIAC|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|03/24/2015|||OK30|NEW TRACEABILITY AND TRACKING SYSTEM AT THE HEREDIA, COSTA RICA LOCATION.
P130021|S011|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE (TM) SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|03/31/2015|||OK30|EXPAND THE CAPACITY OF THE CLEAN ROOMS USED TO MANUFACTURE THE COREVALVETRANSCATHETER AORTIC VALVE AT THE MEDTRONIC MEXICO FACILITY.
P980003|S057|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|03/24/2015|||OK30|NEW TRACEABILITY AND TRACKING SYSTEM AT THE HEREDIA, COSTA RICA LOCATION.
P030017|S218|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2015|04/10/2015|||OK30|UPDATE TO TEST SYSTEM EQUIPMENT AND TEST SOFTWARE.
P050033|S019|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|04/10/2015|||OK30|ACCEPTANCE OF A CHANGE TO SAMPLING FOR A TEST METHOD.
P120016|S013|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|04/09/2015|||OK30|TRANSFER OF THE LOCK AND SLEEVE WITH GRIP SUBASSEMBLY TO A NEW MANUFACTURING LOCATION.
P050044|S030|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT (RT3)|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|04/13/2015|||OK30|CHANGE TO THE RELEASE SPECIFICATION FOR THE VITAGEL SUBASSEMBLY COMPONENT OF THE VITAGEL RT3 SURGICAL HEMOSTAT DEVICE.
P050044|S031|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL SURGICAL HEMOSTAT (RT3)|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|04/14/2015|||OK30|IMPLEMENTATION OF AN ALTERNATIVE CLEANING PROCEDURE FOR EQUIPMENT AND COMPONENTS USED IN THE PRODUCTION OF VITAGEL RT3 SURGICAL HEMOSTAT.
P080011|S036|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/12/2015|04/15/2015|||OK30|CHANGE TO MANUFACTURE ADDITIONAL MULTIFOCAL POWER RANGES OF COMFILCON AN EXTENDED-WEAR CONTACT LENSES.
P130030|S011|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|ELIMINATION OF THE ALIGN STATION OF THE PROXIMAL WELD PROCESS AND CHANGES TO THE HEAT SHRINK REMOVAL PROCESS.
P030017|S219|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/10/2015|||OK30|MANUFACTURING PROCESS CHANGE.
P000012|S053|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST , VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
P050028|S045|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, CONAS AMPLIPREP/COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
P060030|S046|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST,V2.0 FOR USE WITH THE HIGH PURE SYSTEM|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
P100020|S014|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
P110020|S013|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
P110037|S020|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
P120019|S006|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.
P060011|S006|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7|||RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|04/09/2015|||OK30|REMOVAL AND REPLACEMENT OF ONE QUICKVISION UNIT.
P000039|S050|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL DEFECT OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/13/2015|08/14/2015|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT ST. JUDE MEDICAL, COST RICA LTDA.
P950009|S018|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT SLIDE PROFILER|MNM|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/2014|02/12/2016|||APPR|Approval for the BD FocalPoint™ Slide Profiler with slides prepared by the BD Totalys™ SlidePrep.
P100010|S048|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|CRYOCONSOLE|OAE|CV|Real-Time Process||N|03/16/2015|04/03/2015|||APPR|APPROVAL FOR INSTALLATION OF FOUR NEW CATHETER RECOGNITION FILES, AS WELL AS LABELING CHANGES TO THE CRYOCONSOLE OPERATORS MANUAL.
N970012|S106|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS|JCW|GU|30-Day Notice||N|03/16/2015|04/13/2015|||OK30|UPDATE ON SEALING PARAMETERS.
N970012|S107|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS,AMS AMBICOR PENILE PROSTHESIS|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2015|04/15/2015|||OK30|MINOR CHANGES TO THE FILTER PRESS FIXTURE USED IN THE MANUFACTURE OF THE AMS 700 IPP, AMBICOR, AMS 800 AUS, AND ACTICON NEOSPHINCTER DEVICES.
P000053|S058|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SPHINCTER|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2015|04/15/2015|||OK30|MINOR CHANGES TO THE FILTER PRESS FIXTURE USED IN THE MANUFACTURE OF THE AMS 700 IPP, AMBICOR, AMS 800 AUS, AND ACTICON NEOSPHINCTER DEVICES.
P010020|S031|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICON NEOSPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2015|04/15/2015|||OK30|MINOR CHANGES TO THE FILTER PRESS FIXTURE USED IN THE MANUFACTURE OF THE AMS 700 IPP, AMBICOR, AMS 800 AUS, AND ACTICON NEOSPHINCTER DEVICES.
P110023|S014|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2015|04/02/2015|||OK30|REPLACE THE CURRENT THERMAL BONDING MACHINE USED IN THE DISTAL BONDING PROCESS OF THE CATHETER.
P060001|S023|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, ILIAC|PROTEGE GPS CAROTID STENT SYSTEM, PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2015|04/02/2015|||OK30|REPLACE THE CURRENT THERMAL BONDING MACHINE USED IN THE DISTAL BONDING PROCESS OF THE CATHETER.
P890017|S016|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|CORDIS PALMAZ BALLOON-EXPANDABLE STENT|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2015|04/16/2015|||OK30|REPLACE MANUFACTURING EQUIPMENT USED TO SEAL THE PRODUCT PACKAGING WITH AN UPDATED MODEL.
P060037|S035|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2015|04/15/2015|||OK30|CHANGES TO THE FINAL CLEANING.
P030017|S220|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2015|04/14/2015|||OK30|ADDITIONAL COMPONENT SUPPLIER.
P980016|S536|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/2015|09/11/2015|||APPR|APPROVAL OF THE EVERA MRI XT/S DR AND VR IMPLANTABLE CARDIOVERTERDEFIBRILLATOR DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW033 AS WELL AS EXTENSION OF MR CONDITIONAL LABELING AND USE FOR SPRINT QUATTRO SECURE LEAD MODELS 6935M AND 6947M AS MRI SURESCAN LABELED 55 AND 62CM LEADS. IN ADDITION TO THE SYSTEM COMPONENTS LISTED, THE USE OF THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI AND CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 WITH THE EVERA MRI DR (DUAL CHAMBER)SYSTEM WHEN AN ATRIAL PACE/SENSE LEAD IS INDICATED. FURTHERMORE, YOU REQUESTED APPROVAL TO USE CARELINK MONITOR MODEL 2490C, CARELINK EXPRESS MONITOR 2020B, CARDIOSIGHT READER MODEL2020A, MYCARELINK MONITOR MODEL 24950 AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) MODEL 2491 TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE EVERA MRI DEVICES.
P920015|S151|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE S MRI SURESCAN AND SPRINT QUATTRO SECURE MRI SURESCAN|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/2015|09/11/2015|||APPR|APPROVAL OF THE EVERA MRI XT/S DR AND VR IMPLANTABLE CARDIOVERTERDEFIBRILLATOR DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW033 AS WELL AS EXTENSION OF MR CONDITIONAL LABELING AND USE FOR SPRINT QUATTRO SECURE LEAD MODELS 6935M AND 6947M AS MRI SURESCAN LABELED 55 AND 62CM LEADS. IN ADDITION TO THE SYSTEM COMPONENTS LISTED, THE USE OF THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI AND CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 WITH THE EVERA MRI DR (DUAL CHAMBER)SYSTEM WHEN AN ATRIAL PACE/SENSE LEAD IS INDICATED. FURTHERMORE, YOU REQUESTED APPROVAL TO USE CARELINK MONITOR MODEL 2490C, CARELINK EXPRESS MONITOR 2020B, CARDIOSIGHT READER MODEL2020A, MYCARELINK MONITOR MODEL 24950 AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) MODEL 2491 TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE EVERA MRI DEVICES.
P890003|S329|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR AND EXPRESS MONITOR, CARDIOSIGHT READER; CARELINK EXPRESS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/2015|09/11/2015|||APPR|APPROVAL OF THE EVERA MRI XT/S DR AND VR IMPLANTABLE CARDIOVERTERDEFIBRILLATOR DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW033 AS WELL AS EXTENSION OF MR CONDITIONAL LABELING AND USE FOR SPRINT QUATTRO SECURE LEAD MODELS 6935M AND 6947M AS MRI SURESCAN LABELED 55 AND 62CM LEADS. IN ADDITION TO THE SYSTEM COMPONENTS LISTED, THE USE OF THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI AND CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 WITH THE EVERA MRI DR (DUAL CHAMBER)SYSTEM WHEN AN ATRIAL PACE/SENSE LEAD IS INDICATED. FURTHERMORE, YOU REQUESTED APPROVAL TO USE CARELINK MONITOR MODEL 2490C, CARELINK EXPRESS MONITOR 2020B, CARDIOSIGHT READER MODEL2020A, MYCARELINK MONITOR MODEL 24950 AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) MODEL 2491 TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE EVERA MRI DEVICES.
P860057|S134|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTER-EDWARDS  PERIMOUNT  BIOPROSTHESIS HEART VALVE FAMILIES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2015|04/16/2015|||OK30|RELOCATION OF THE SUPPLIER OF THE 3.8 OUNCE PACKAGING JARS USED FOR SURGICAL AND TRANSCATHETER HEART VALVES.
P130009|S031|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2015|04/16/2015|||OK30|RELOCATION OF THE SUPPLIER OF THE 3.8 OUNCE PACKAGING JARS USED FOR SURGICAL AND TRANSCATHETER HEART VALVES.
P120005|S034|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2015|04/16/2015|||OK30|CHANGE TO THE CONFIGURATION OF THE CONTROLLED ENVIRONMENT ROOMS INTENDED FOR THE MANUFACTURING OF THE G4 PLATINUM SENSOR/APPLICATOR USED IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
P100022|S013|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|03/17/2015|06/08/2015|||APPR|APPROVAL FOR A POST-APPROVAL STUDY PROTOCOL.
P130009|S032|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2015|04/13/2015|||OK30|ALTERNATE SAMPLING PLAN FOR THE STENT COMPONENT.
P980022|S180|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/16/2015|||OK30|TRANSFER OF PURCHASING, RECEIVING, AND INCOMING INSPECTION ACTIVITIES OFCERTAIN EXTERNAL INSULIN PUMP COMPONENTS USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIMEPUMP SERIES AND THE MINIMED 530G SERIES FROM THE MEDTRONIC MINIMED NORTHRIDGE FACILITY TO THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY AND FEDEX/3PL FACILITIES IN PUERTO RICO. THE PARADIGM REAL?]TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
P120010|S065|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMPS|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/16/2015|||OK30|TRANSFER OF PURCHASING, RECEIVING, AND INCOMING INSPECTION ACTIVITIES OFCERTAIN EXTERNAL INSULIN PUMP COMPONENTS USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIMEPUMP SERIES AND THE MINIMED 530G SERIES FROM THE MEDTRONIC MINIMED NORTHRIDGE FACILITY TO THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY AND FEDEX/3PL FACILITIES IN PUERTO RICO. THE PARADIGM REAL?]TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
P040008|S011|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/22/2015|||OK30|CHANGE TO REMOVE EXTRANEOUS IN-PROCESS STABILITY TESTS PERFORMED ON THE STRIPS (STR) AND ON THE SOLID PHASE RECEPTACLES (SPR) OF THE KIT, AND CONSEQUENTLY TO ADD AN INSTRUCTION FOR THE STORAGE OF THE STR DURING THE MANUFACTURING PROCESS.
P020036|S032|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|CORDIS SMART CONTROL NITINOL STENT SYSTEMS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/16/2015|||OK30|REMOVAL OF A REDUNDANT MANUFACTURING IN-PROCESS WATERBORNE TESTING STEP USED IN THE STENT CLEANING PROCESS.
P120002|S008|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|SMART CONTROL VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/16/2015|||OK30|REMOVAL OF A REDUNDANT MANUFACTURING IN-PROCESS WATERBORNE TESTING STEP USED IN THE STENT CLEANING PROCESS.
P030047|S028|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE NITINOL STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/16/2015|||OK30|REMOVAL OF A REDUNDANT MANUFACTURING IN-PROCESS WATERBORNE TESTING STEP USED IN THE STENT CLEANING PROCESS.
P030005|S119|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INGENIO 2 CRT-P DEVICES|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2015|05/19/2015|||APPR|APPROVAL FOR DESIGN CHANGES TO THE IS4 OUTER SLEEVE AND VERTICAL INTEGRATION OF IS4 OUTER SLEEVE MANUFACTURING.
P810006|S062|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/14/2015|||OK30|QUALIFICATION OF TWO NEW SPECTROPHOTOMETERS.
P850010|S061|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/14/2015|||OK30|QUALIFICATION OF TWO NEW SPECTROPHOTOMETERS.
P140010|S004|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS ANGIOPLASTY BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/06/2015|||OK30|THE ADDITION OF A NEW CLEANROOM FOR A COATING PROCEDURE AS WELL AS THE RELOCATION OF THE OUTER PACKING PROCESS.
P840062|S046|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSINGS|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/14/2015|||OK30|QUALIFICATION OF TWO NEW SPECTROPHOTOMETERS.
P900033|S045|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2015|04/14/2015|||OK30|QUALIFICATION OF TWO NEW SPECTROPHOTOMETERS.
P990009|S040|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|08/21/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAXTER HEALTHCARE CORPORATION,IN CLEVELAND, MISSISSIPPI.
P840001|S298|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCE, SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|04/17/2015|||OK30|ADDITION OF ALTERNATE UV IRRADIATOR EQUIPMENT.
P100033|S003|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Prostrate cancer genes nucleic acid amplification test system|PROGENSA PCA3 ASSAY|OYM|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|04/16/2015|||OK30|MANUFACTURING SCALE UP OF BULK ENZYME RECONSTITUTION SOLUTION (P/N BS0421), BY ALLOWING BULKING AND FILLING FROM LARGER TANKS (208L AND 303L) AND ADDITIONALLY, TOEXTEND THE BULK HOLD TIME FROM 7 DAYS UP TO 1 MONTH TO ALLOW SUFFICIENT TIME FOR THE SOLUTION TO BE USED WITHIN MANUFACTURING.
P120002|S009|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|11/25/2015|||APPR|APPROVAL FOR REMOVAL OF PERFLUORO-OCTANOIC ACID (PFOA) FROM THE POLYTETRAFLUORO-ETHYLENE (PTFE) TUBING.
P860004|S226|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|04/17/2015|||OK30|ADDITION OF ALTERNATE UV IRRADIATOR EQUIPMENT.
P960009|S224|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|04/17/2015|||OK30|ADDITION OF ALTERNATE UV IRRADIATOR EQUIPMENT.
P970004|S196|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|04/17/2015|||OK30|ADDITION OF ALTERNATE UV IRRADIATOR EQUIPMENT.
P080025|S091|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|04/17/2015|||OK30|ADDITION OF ALTERNATE UV IRRADIATOR EQUIPMENT.
P030047|S029|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|11/25/2015|||APPR|APPROVAL FOR REMOVAL OF PERFLUORO-OCTANOIC ACID (PFOA) FROM THE POLYTETRAFLUORO-ETHYLENE (PTFE) TUBING.
P020036|S033|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|11/25/2015|||APPR|APPROVAL FOR REMOVAL OF PERFLUORO-OCTANOIC ACID (PFOA) FROM THE POLYTETRAFLUORO-ETHYLENE (PTFE) TUBING.
P030053|S026|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/19/2015|04/15/2015|||OK30|CHANGE TO ADD AN ALTERNATE SUPPLIER FOR ISOPROPYL ALCOHOL (IPA) USED IN THE MANUFACTURE OF MENTOR MEMORYGEL BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.
P030009|S080|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P110013|S050|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P070027|S041|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P100021|S046|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT AND ENDURANT II STENT SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P100040|S020|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENTGRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P110011|S010|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COLBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P090006|S015|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P110040|S006|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE VASCULAR STENT SYSTEM|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P130021|S012|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|COREVALVE SYSTEM|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P810006|S063|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|04/16/2015|||OK30|MATERIAL CHANGE FOR THE PIPE THAT LEADS TO CROSSLINKING CHAMBER 2, AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
P850010|S062|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|04/16/2015|||OK30|MATERIAL CHANGE FOR THE PIPE THAT LEADS TO CROSSLINKING CHAMBER 2, AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
P840062|S047|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG, ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|04/16/2015|||OK30|MATERIAL CHANGE FOR THE PIPE THAT LEADS TO CROSSLINKING CHAMBER 2, AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.
P130019|S003|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|04/22/2015|||OK30|ACCEPTANCE OF THE ADDITION OF AN IN PROCESS MANUFACTURING TOOL.
P140010|S005|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL DCB|ONU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/20/2015|07/09/2015|||APPR|APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
P980035|S416|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSIA, SENSIA IPG, ADVISA DR IPG, ADVISA SR MRI IPG, ADVISA DR MRI IPG AND RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/02/2015|||OK30|CHANGE TO THE EXTERNAL APPEARANCE AND WORKMANSHIP STANDARD FOR PLASTIC MOLDED CONNECTOR MODULES AND SURROUNDS.
P090013|S180|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/02/2015|||OK30|CHANGE TO THE EXTERNAL APPEARANCE AND WORKMANSHIP STANDARD FOR PLASTIC MOLDED CONNECTOR MODULES AND SURROUNDS.
P060040|S041|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LVAS|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2015|06/03/2015|||APPR|APPROVAL FOR THE UNSHIELDED 14V POWER MODULE PATIENT CABLE.
P010015|S269|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/13/2015|||OK30|UPDATE TO THE PYCNOMETRY TESTING FOR THE BATTERY OF THE DEVICES.
P090013|S181|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/13/2015|||OK30|UPDATE TO THE PYCNOMETRY TESTING FOR THE BATTERY OF THE DEVICES.
P980035|S417|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/13/2015|||OK30|UPDATE TO THE PYCNOMETRY TESTING FOR THE BATTERY OF THE DEVICES.
P980040|S060|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/17/2015|||OK30|ALTERNATIVE MOLDING SUPPLIER FOR THE UPPER BODY COMPONENT OF THE TECNIS® PRELOADED DELIVERY SYSTEMS (MODELS PCB00, PMB00, PCT150, PCT225, PCT300, AND PCT400) AND AN ALTERNATIVE MOLD SUPPLIER FOR THE 1MTEC30 CARTRIDGE, LOWER BODY AND PROTECTOR CAP COMPONENTS.
P840062|S048|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/22/2015|||OK30|PROPOSED QUALIFICATION OF THE LYO TRAY HANDLING CONVEYOR SYSTEM LOCATED AT THE INTEGRA NEUROSCIENCES, AÑASCO, PUERTO RICO FACILITY, FOR THE DEVICES.
P070004|S008|SIENTRA, INC|6769 HOLLISTER AVENUE|SUITE 201|SANTA BARBARA|CA|93117||Prosthesis, breast, noninflatable, internal, silicone gel-filled|SIENTRA SILICONE GEL BREAST IMPLANTS|FTR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2015|12/02/2016|||APPR|Approval for new implant styles 20512-MP, 20712-MP, 20646-RB (MP), and 20676-E (HP); and additional sizes of the following styles: 10621-HP, 10721-HP, 20621-HP, 20721-HP, 20645-LP, 20645-MP, 20645-HP, 20646-RB (HP), and 20646-RB (MP).
P810006|S064|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/22/2015|||OK30|PROPOSED QUALIFICATION OF THE LYO TRAY HANDLING CONVEYOR SYSTEM LOCATED AT THE INTEGRA NEUROSCIENCES, AÑASCO, PUERTO RICO FACILITY, FOR THE DEVICES.
P850010|S063|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/22/2015|||OK30|PROPOSED QUALIFICATION OF THE LYO TRAY HANDLING CONVEYOR SYSTEM LOCATED AT THE INTEGRA NEUROSCIENCES, AÑASCO, PUERTO RICO FACILITY, FOR THE DEVICES.
P900033|S046|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/22/2015|||OK30|PROPOSED QUALIFICATION OF THE LYO TRAY HANDLING CONVEYOR SYSTEM LOCATED AT THE INTEGRA NEUROSCIENCES, AÑASCO, PUERTO RICO FACILITY, FOR THE DEVICES.
P830055|S157|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process||N|03/23/2015|06/05/2015|||APPR|APPROVAL FOR THE ADDITION OF ATTUNE CEMENTLESS CRUCIATE RETAINING(CR) AND POSTERIOR STABILIZED (PS) FEMORAL COMPONENTS AS COMPATIBLE COMPONENTS WITH THEAPPROVED ATTUNE CR AND PS ROTATING PLATFORM (RP) TIBIAL INSERTS AND ATTUNE RP (CEMENTED) TIBIAL BASES.  INCLUDING STERILE SINGLE USE INSTRUMENTATION, TO BE USED WITH THE APPROVED ATTUNE RP COMPONENTS.
P090018|S029|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2015|06/19/2015|||APPR|APPROVAL FOR A CHANGE TO THE UV EPOXY MATERIAL IN THE HEADER CONNECTOR OF THE SOUND PROCESSOR AND FOR A NEW PLASMA PRE-TREATMENT STEP TO ENHANCE ADHESION OF THE SILICONE DIP COATING.
P130019|S004|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/22/2015|||OK30|ACCEPTANCE OF A CHANGE TO THE RELEASE PROCEDURE.
P860057|S135|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT AORTIC & MITRAL BIOPROSTHESIS FAMILIES|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2015|06/11/2015|||APPR|APPROVAL FOR MODIFICATION (ELIMINATION) TO THE CENTRAIL-HOLE-IN-AIR SPECIFICATION.
P840001|S299|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL,  SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY, VECTRIS SPINAL CORD STIMULAION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/22/2015|||OK30|CHANGE THE PARTS CLEANING PROCESS.
P110023|S015|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM|NIP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|06/24/2015|||APPR|APPROVAL FOR ALTERNATE STENT LASER CUTTING EQUIPMENT.
P970003|S178|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|DEMIPULSE MODEL 103 GENERATOR|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2015|04/22/2015|||OK30|USE OF A NEW INSPECTION SYSTEM.
P050023|S085|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|INVENTRA CRT-D|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2015|06/19/2015|||APPR|APPROVAL FOR THE QP CRT-D DEVICE MODELS WITH ONE IS4 PORT, ONE IS-1 PORT AND ONE DF4 PORT ALONG WITH A UPDATED SOFTWARE ¿ PSW 1502.U FOR THE DEVICES.
P950037|S150|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|DROMOS DRISK RATE ADAPTIVE PACEING SYSTEM|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2015|06/19/2015|||APPR|APPROVAL FOR THE QP CRT-D DEVICE MODELS WITH ONE IS4 PORT, ONE IS-1 PORT AND ONE DF4 PORT ALONG WITH A UPDATED SOFTWARE ¿ PSW 1502.U FOR THE DEVICES.
P000009|S062|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PHYLAX AV ICD SYSTEM|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2015|06/19/2015|||APPR|APPROVAL FOR THE QP CRT-D DEVICE MODELS WITH ONE IS4 PORT, ONE IS-1 PORT AND ONE DF4 PORT ALONG WITH A UPDATED SOFTWARE ¿ PSW 1502.U FOR THE DEVICES.
P070008|S062|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2015|06/19/2015|||APPR|APPROVAL FOR THE QP CRT-D DEVICE MODELS WITH ONE IS4 PORT, ONE IS-1 PORT AND ONE DF4 PORT ALONG WITH A UPDATED SOFTWARE  PSW 1502.U FOR THE DEVICES.
P970051|S129|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process||N|03/23/2015|06/23/2015|||APPR|APPROVAL FOR DESIGN CHANGES TO THE CP900 SERIES PROCESSOR COILWHICH MAKES THE CP900 SERIES PROCESSOR COMPATIBLE WITH THE N22 IMPLANT AND ALLOWS RECIPIENTS OF THE N22 IMPLANT ACCESS TO THE NEWEST PROCESSOR TECHNOLOGY.
P900056|S145|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTAWIRE ELITE GUIDEWIRE|MCX|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|03/23/2015|06/19/2015|||APPR|APPROVAL FOR A CORE WIRE VENDOR CHANGE AND THE ASSOCIATED REBRANDING OF THE ROTAWIRE  GUIDEWIRE AS THE ROTAWIRE ELITE GUIDEWIRE.
P130019|S005|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2015|04/24/2015|||APPR|APPROVAL FOR A FORMULATION CHANGE TO YOUR SILICONE MATERIAL USED IN THE TRANSMIT COILS FOR THE MAESTRO® RECHARGEABLE SYSTEM.
P980035|S418|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA SR MRI|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2015|04/21/2015|||OK30|FOURTEEN (14) MANUFACTURING CHANGES FOR ADVISA SR MRI THAT HAD BEEN PREVIOUSLY REVIEWED AND ACCEPTED TO ALIGN THE ADVISA SR MRI MANUFACTURING PROCESS WITH THE PREDECESSOR DEVICE MANUFACTURING PROCESSES:1) TOOLING CHANGES AND ALTERNATE SUPPLIER FOR FT INSULATOR; 2) MANUFACTURING PROCESS CHANGE FOR PRINTED WIRING BOARD SUBSTRATES; 3) LEAK CHECK TESTER WITH SOFTWARE UPDATES; 4) NEW MATERIAL SUPPLIER AND SPECIFICATION UPDATE FOR P(ETFE); 5) PLASMA CLEANING PROCESS CHANGE; 6) FACTORYWORKS RELEASE 7.11; AND7) SPACE DATA COLLECTOR TRACKING SYSTEM UPDATE AT NIKON ROUT; 8) UPDATE TO FINAL ASSEMBLY PROCESSING TEMPERATURE REQUIREMENTS 9) UNIVERSAL BURN IN TEST SYSTEM (UBITS) SOFTWARE UPDATE; 10) MODIFY IN-PROCESS BATTERY INSPECTION REQUIREMENTS; 11) VISION SYSTEM IMPLEMENTATION AT MJC STERILIZATION AREA; 12) VISION SYSTEM FOR CONNECTOR AND RADIOPAQUE VERIFICATION AT SMO; 13) IC DIE SORTER EQUIPMENT SOFTWARE CONFIGURATION UPDATE; AND 14) FINAL VISUAL CRITERIA CHANGE.
P980035|S419|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA SR MRI|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2015|04/21/2015|||OK30|NINE (9) MANUFACTURING CHANGES FOR ADVISA SR MRI THAT HAD BEEN PREVIOUSLY REVIEWED AND ACCEPTED TO ALIGN THE ADVISA SR MRI MANUFACTURING PROCESS WITH THE PREDECESSOR DEVICE MANUFACTURING PROCESSES:1) ANTENNA WIRE BOND COAT MANUFACTURING STANDARDIZATION; 2) UPDATE TO DISTRIBUTION CENTER SORTER TOOL (DCST) SYSTEM; 3) NEW SUPPLIER FOR GOLD PREFORM COMPONENT (BRAZING PREFORM FOR FEED-THROUGH MANUFACTURING);4) SECOND SOURCE SUPPLIER OF ANODE SUBSTRATES; 5) VAPOR DEGREASER CLEANING BACK PROLIFERATION TO LEGACY PRODUCTS; 6) NEW 3D LASER MARKER AT MJC; 7) STATEK CRYSTAL WITH PRE-PLATED CERAMIC BASE STATEK CRYSTAL WITH PRE-PLATED CERAMIC BASE;8) ALTERNATIVE UV IRRADIATION EQUIPMENT FOR DIEPREP AREA; AND 9) MODIFICATION OF M017/M019 PROBE TEST SOFTWARE.
P910056|S019|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ENVISTA HYDROPHOBIC INTRAOCULAR LENS|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|11/19/2015|||APPR|APPROVAL FOR AN ALTERNATE COMPONENT SUPPLIER FOR THE ACRYLIC SHEET USED TO MILL ENVISTA® HYDROPHOBIC INTRAOCULAR LENS BUTTONS (MODEL MX60). SPECIFICALLY, THE SHEET MANUFACTURING PROCESS IS TO ALTERNATIVELY TRANSFER TO THE BAUSCH AND LOMB FACILITY IN WILMINGTON, MASSACHUSETTS (WIL).
P830061|S119|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/10/2015|||OK30|MANUFACTURING TRANSFER OF THE SPACER-TIP TO RING COMPONENT TO A SUPPLIER.
P130019|S006|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2015|04/17/2015|||APPR|APPROVAL FOR A CHANGE TO THE LOW BATTERY THRESHOLD OF THE MOBILE CHARGER FOR THE MAESTRO® RECHARGEABLE SYSTEM.
P130021|S013|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE (R) SYSTEM|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/25/2015|08/03/2015|||APPR|APPROVAL FOR THE REVISED PLUNGER ASSEMBLY FOR THE ACCUTRAK DELIVERY CATHETER SYSTEM (DCS).
P040044|S063|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/24/2015|||OK30|CHANGE THE BALLOON MATERIAL RESIN OF THE MYNXGRIP VASCULAR CLOSURE DEVICE.
P960040|S344|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INOGEN, ORIGEN AND DYNAGEN ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/02/2015|||OK30|ACCEPTANCE OF NEW TEMPERATURE RECORDERS FOR USE AT THE CLONMEL, IRELAND LOCATION.
P910023|S356|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/17/2015|||OK30|ALTERNATE BURN-IN USING VOLTAGE ACCELERATION FOR HYBRID SUBASSEMBLIES USED IN THE DEVICES.
P010012|S386|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||INOGEN, ORIGEN AND DYNAGEN CRT-D'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/02/2015|||OK30|ACCEPTANCE OF NEW TEMPERATURE RECORDERS FOR USE AT THE CLONMEL, IRELAND LOCATION.
P030054|S285|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/17/2015|||OK30|ALTERNATE BURN-IN USING VOLTAGE ACCELERATION FOR HYBRID SUBASSEMBLIES USED IN THE DEVICES.
P860057|S136|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BI|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/23/2015|||OK30|ADD A CLEANROOM AND EXTEND A SOLUTION PIPING SYSTEM IN THE HORW MANUFACTURING FACILITY.
P130008|S007|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|MODEL 3024 INSPIRE II IMPLANTABLE PULSE GENERATOR (IPG)|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/22/2015|||OK30|IMPLEMENTATION OF AN AUTOMATED SYSTEM FOR INSPECTION OF FINAL SEALED TRAY PACKAGES AND A CHANGE IN THE SUPPLIER OF GOLD PREFORM COMPONENTS.
P100049|S012|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2015|04/21/2015|||OK30|1) UTILIZATION OF AN IN-HOUSE LASER WELDING SYSTEM;2) UTILIZATION OF IN-HOUSE HERMETICITY TESTING SYSTEMS;3) UTILIZATION OF AN IN-HOUSE WIRE CUTTING PROCESS;4) UTILIZATION OF AN IN-HOUSE PNEUMATIC WIRE LINK BENDING PROCESS; AND5) MODIFICATION OF AN INCOMING INSPECTION ACCEPTANCE CRITERION FOR ONE OF THE MAGNET TYPES.
P950018|S018|ALCON LABORATORIES|6201 SOUTH FREEWAY R3-48||FORT WORTH|TX|76134||Fluid, intraocular|PERFLUORON|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2015|04/22/2015|||OK30|ADDITION OF AN ALTERNATE STERILIZER.
P120012|S007|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|REALTIME HCV GENOTYPE II|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2015|04/23/2015|||OK30|CHANGE TO IMPLEMENT A NEW FULLY AUTOMATED SYSTEM FOR FILLING AND CAPPING COMPONENT BOTTLES.
P080026|S014|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV ASSAY|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2015|04/23/2015|||OK30|CHANGE TO IMPLEMENT A NEW FULLY AUTOMATED SYSTEM FOR FILLING AND CAPPING COMPONENT BOTTLES.
P100017|S012|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2015|04/23/2015|||OK30|CHANGE TO IMPLEMENT A NEW FULLY AUTOMATED SYSTEM FOR FILLING AND CAPPING COMPONENT BOTTLES.
P010015|S270|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2015|05/27/2015|||APPR|APPROVAL OF A CHANGE TO THE ELECTRONIC MODULE ASSEMBLY SPECIFICATION.
P980035|S420|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA SR MRI IPG AND ADVISA DR MRI IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2015|05/27/2015|||APPR|APPROVAL OF A CHANGE TO THE ELECTRONIC MODULE ASSEMBLY SPECIFICATION.
P090013|S182|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2015|04/21/2015|||OK30|IMPLEMENTATION OF A MULTIPLE ROTARY FIXTURE, UPDATES TO WELDING PARAMETERS, AND UPDATES TO WELDING INSTRUCTIONS.
P930039|S127|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/26/2015|04/21/2015|||OK30|IMPLEMENTATION OF A MULTIPLE ROTARY FIXTURE, UPDATES TO WELDING PARAMETERS, AND UPDATES TO WELDING INSTRUCTIONS.
P130007|S002|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/26/2015|06/22/2015|||APPR|APPROVAL FOR SUBSTITUTION OF 4 COMPONENTS (MEMORY, TRANSISTOR, MICRO-PROCESSING UNIT, CONNECTOR) ON THE PRINTED CIRCUIT BOARD (PCB) OF THE APPROVED ANIMAS VIBE INSULIN PUMP. ONE OF THE REPLACEMENT COMPONENTS (MICRO-PROCESSING UNIT) REQUIRES A MODIFICATION TO THE PCB LAYOUT.
P040047|S038|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2015|10/28/2015|||APPR|APPROVAL FOR THE IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION SYSTEM THAT REPLACES A MANUAL VISUAL INSPECTION PROCESS.
P050037|S056|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORATION AND OR CORRECTION FOR THE SIGNS OF FACIAL FAT LO|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2015|10/28/2015|||APPR|APPROVAL FOR THE IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION SYSTEM THAT REPLACES A MANUAL VISUAL INSPECTION PROCESS.
P050052|S062|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, RADIESSE (+), RADIESSE WITH LIDOCAINE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2015|10/28/2015|||APPR|APPROVAL FOR THE IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION SYSTEM THAT REPLACES A MANUAL VISUAL INSPECTION PROCESS.
P990046|S040|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|MEDTRONIC OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2015|05/15/2015|||OK30|NEW ALANINE DOSIMETRY SYSTEM AT STERIS ISOMEDIX SERVICES(LIBERTYVILLE, ILLINOIS).
P130026|S003|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/27/2015|04/30/2015|||APPR|APPROVAL FOR PACKAGING CHANGES TO THE TACTICATH QUARTZ SET.
P060038|S023|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2015|04/23/2015|||OK30|REMOVE A QUALITY CONTROL INSPECTION FOR A SEWING RING MATERIAL.
P820003|S133|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|VERSATRAX IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2015|04/02/2015|||OK30|ACCEPTANCE OF A NEW DOSIMETRY SYSTEM AT THE LIBERTYVILLE, IL LOCATION.
P050023|S086|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|LUMAX DR-T, LUMAX VR-T AND LUMAX CRT-D|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/27/2015|05/27/2015|||APPR|APPROVAL FOR AN ALTERNATE BATTERY SEPARATOR MATERIAL.
P930029|S050|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|ATAKR RADIO FREQUENCY (RF) CATHETER ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/27/2015|04/02/2015|||OK30|ACCEPTANCE OF A NEW DOSIMETRY SYSTEM AT THE LIBERTYVILLE, IL LOCATION.
P970018|S032|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD PREPSTAIN SYSTEM|MKQ|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/26/2015|02/12/2016|||APPR|Approval for the BD Totalys™ MultiProcessor, a new cell enrichment system, and the BD SurePath™ collection vial.
P910056|S020|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ENVISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2015|04/29/2015|||OK30|ADDITION OF AN ALTERNATIVE IN VITRO PYROGEN TESTING (IPT) LAB FOR THE ENVISTA® HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL) MODEL MX60.
P030017|S221|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2015|04/29/2015|||OK30|ADDITION OF AN ALTERNATE TEST EQUIPMENT SYSTEM.
P810006|S065|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2015|04/29/2015|||OK30|QUALIFICATION OF A NEW THERMAL TRANSFER PRINTER.
P850010|S064|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2015|04/29/2015|||OK30|QUALIFICATION OF A NEW THERMAL TRANSFER PRINTER.
P100009|S010|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER|NKM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2015|11/18/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS US, LLC, IN LOS ANGELES, CALIFORNIA.
P830055|S158|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)||N|03/30/2015|04/29/2015|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP.
P840062|S049|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2015|04/29/2015|||OK30|QUALIFICATION OF A NEW THERMAL TRANSFER PRINTER.
P000037|S040|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2015|09/15/2015|||APPR|APPROVAL TO ADD A SECOND VACUUM-ASSISTED STEAM STERILIZER.
P950029|S105|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY DR, REPLY SR, ESPRIT DR, ESPRIT SR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/2015|06/24/2016|||APPR|Approval for hardware modifications to the REPLY/ESPRIT pacemaker platform.
P980049|S109|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ORCHESTRA AND ORCHESTRA PLUS PROGRAMMER|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/2015|06/24/2016|||APPR|Approval for hardware modifications to the REPLY / ESPRIT pacemaker platform.
P020004|S112|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2015|04/23/2015|||OK30|CHANGE IN PROCESSING TEMPERATURE AT A SUPPLIER MANUFACTURING FACILITY FOR THE PRODUCTION OF MID AND TRAILING OLIVES USED ON C3 DELIVERY CATHETERS.
N16837|S020|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/2015|04/29/2015|||APPR|APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE BROCHURE INCLUDING: 1) CHANGE THE SIZE LABELING CONVENTION FROM OUTER TO INNER DIAMETER; AND 2) THE ADDITION OF AN INFORMATION STATEMENT NOT MADE WITH NATURAL RUBBER LATEX.
P090013|S183|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2015|04/21/2015|||OK30|CLARIFICATIONS OF THE TEMPERATURE EXPOSURE REQUIREMENTS DURING MANUFACTURING.
P980040|S061|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||SENSAR SOFT ACRYLIC INTRAOCULAR LENSES||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2015|05/01/2015|||OK30|IMPLEMENTATION OF A NEW METHOD FOR MEASUREMENT OF THE OPTICAL PROPERTIES(DIOPTER AND IMAGE QUALITY) OF THE 3-PIECE ACRYLIC AND SILICONE IOLS PRODUCED AT AMO¿S PUERTO RICO FACILITY.
P990080|S039|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2015|05/01/2015|||OK30|IMPLEMENTATION OF A NEW METHOD FOR MEASUREMENT OF THE OPTICAL PROPERTIES(DIOPTER AND IMAGE QUALITY) OF THE 3-PIECE ACRYLIC AND SILICONE IOLS PRODUCED AT AMO¿S PUERTO RICO FACILITY.
P880081|S039|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS CL FOLDABLE SILICONE INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/01/2015|05/01/2015|||OK30|IMPLEMENTATION OF A NEW METHOD FOR MEASUREMENT OF THE OPTICAL PROPERTIES(DIOPTER AND IMAGE QUALITY) OF THE 3-PIECE ACRYLIC AND SILICONE IOLS PRODUCED AT AMO¿S PUERTO RICO FACILITY.
P030002|S034|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS|MJP|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/01/2015|06/02/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P990075|S032|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2015|04/29/2015|||OK30|CHANGE TO CONVERT AN EXISTING IN-PROCESS COMPONENT STORAGE AREA INTO A CLEAN MANUFACTURING ENVIRONMENT (CME) FOR THE MANUFACTURE OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED, MEMORYSHAPE, AND SALINE-FILLED AND SPECTRUM BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P030053|S027|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2015|04/29/2015|||OK30|CHANGE TO CONVERT AN EXISTING IN-PROCESS COMPONENT STORAGE AREA INTO A CLEAN MANUFACTURING ENVIRONMENT (CME) FOR THE MANUFACTURE OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED, MEMORYSHAPE, AND SALINE-FILLED AND SPECTRUM BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P060028|S010|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice||N|04/02/2015|04/29/2015|||OK30|CHANGE TO CONVERT AN EXISTING IN-PROCESS COMPONENT STORAGE AREA INTO A CLEAN MANUFACTURING ENVIRONMENT (CME) FOR THE MANUFACTURE OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED, MEMORYSHAPE, AND SALINE-FILLED AND SPECTRUM BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P100044|S017|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT|OWO|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2015|05/07/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH AST IN DENVER, COLORADO.
P040047|S039|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE INJECTABLE IMPLANT|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2015|04/29/2015|||OK30|IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION SYSTEM FOR PRINTED MEDIA.
P010032|S096|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PROCLAIM NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/02/2015|11/02/2015|||APPR|APPROVAL FOR PROCLAIM NEUROSTIMULATION SYSTEM.
P090016|S015|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BOLOTERO BALANCE INJECTABLE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2015|04/29/2015|||OK30|IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION SYSTEM FOR PRINTED MEDIA.
N18033|S076|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2015|05/01/2015|||OK30|IMPLEMENTATION OF A SECOND SUPPLIER SOURCE FOR THE PRIMARY PACKAGE BLISTER BOWL.
P040045|S050|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice||N|04/03/2015|05/01/2015|||OK30|IMPLEMENTATION OF A SECOND SUPPLIER SOURCE FOR THE PRIMARY PACKAGE BLISTER BOWL.
P050037|S057|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2015|04/29/2015|||OK30|IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION SYSTEM FOR PRINTED MEDIA.
P050052|S063|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE & RADIESSE (+) DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/02/2015|04/29/2015|||OK30|IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION SYSTEM FOR PRINTED MEDIA.
P080006|S078|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN PERFORMA|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2015|04/28/2015|||OK30|THE FOLLOWING MANUFACTURING CHANGES:1) THE ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS; 2) USE OF FACTORYWORKS RELEASE 7.9 MANUFACTURING SOFTWARE; 3) A REDUCTION IN THE EXPOSURE TIME DURING ETHYLENE OXIDE HALF-CYCLE TESTING; 4) A REDUCTION IN THE FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFICMANUFACTURING AREAS; 5) AN UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE; AND 6) USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
P120016|S014|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM  (VCS)|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/03/2015|09/30/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARDIVA MEDICAL, INC., SONORA, MEXICO.
P930014|S079|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ POSTERIOR CHAMBER IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2015|05/05/2015|||OK30|ALTERNATIVE SUPPLIER FOR THE POLYPROPYLENE RESIN MATERIAL FOR THE ACRYSERT® C DELIVERY SYSTEM.
P110009|S010|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/06/2015|10/06/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE MOBI-C LABELING.
P010014|S051|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2015|05/06/2015|||APPR|APPROVAL FOR ADDITIONAL INSPECTION STEP.
P110002|S010|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/06/2015|10/06/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE MOBI-C LABELING.
P080009|S007|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|04/06/2015|10/06/2015|||APPR|APPROVAL FOR SOFTWARE CHANGES TO RESOLVE THREE ANOMALIES.
P980040|S062|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS TORIC 1-PIECE INTRAOCULAR LENS|HQL|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/02/2015|08/25/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDYPROTOCOL.
P110010|S105|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM-OTW|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/07/2015|06/02/2015|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE STENT DELIVERY SYSTEM MANIFOLD.
P110028|S016|ABBOTT VASCULAR INC.|3200 LAKESIDE DRIVE||SANTA CLARA|CA|92054||STENT, ILIAC|ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2015|07/30/2015|||APPR|APPROVAL TO MANUFACTURE A COMPONENT OF THE CATHETER IN-HOUSE.
P980044|S025|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX|MOZ|OR|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/07/2015|05/20/2015|||APPR|APPROVAL FOR A CHANGE OF THE TRADE NAME OF YOUR DEVICE FROM SUPARTZ TO SUPARTZ FX. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUPARTZ FX AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE, NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P040003|S016|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE|NRZ|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/07/2015|10/05/2015|||APPR|APPROVAL FOR CHANGES TO THE SOFTWARE OF THE EXABLATE SYSTEM INCLUDING ENABLING MOVEMENT OF THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTION. THE MODIFIED DEVICE IS REFERRED TO AS THE EXABLATE 2100 V1.1 WITH SOFTWARE VERSION 6.5.
P060002|S036|BARD PERIPHERAL VASCULAR|1625 W. THIRD ST||TEMPE|AZ|85281||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|FLAIR ENDOVASCULAR STENT GRAFT|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/16/2016|||APPR|Approval of a new polytetrafluoroethylene (PTFE) resin.
P130029|S001|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|FLUENCY PLUS ENDOVASCULAR STENT GRAFT|PFV|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/16/2016|||APPR|Approval of a new polytetrafluoroethylene (PTFE) resin.
P100009|S011|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM, MITRACLIP STEERABLE GUIDE CATHETER|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/07/2015|||OK30|ADD A DIMENSIONAL MEASUREMENT SYSTEM.
N970012|S108|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS (IPP)|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/06/2015|||OK30|ADDITION OF THREE (3) DUPLICATE OVENS AS BACK-UP EQUIPMENT.
P000053|S059|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/06/2015|||OK30|ADDITION OF THREE (3) DUPLICATE OVENS AS BACK-UP EQUIPMENT.
P010020|S032|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWL SPHINCTER (ABS)|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/06/2015|||OK30|ADDITION OF THREE (3) DUPLICATE OVENS AS BACK-UP EQUIPMENT.
P010019|S038|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/05/2015|||OK30|CHANGING THE NACL ION PERMEABILITY TEST TO CORRECT FOR VARIABLE THICKNESS LENSES AND THE ASSOCIATED SOFTWARE UPDATE.
P030053|S028|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/08/2015|||OK30|CHANGE TO USE SEGREGATION BASKETS FOR IN-PROCESS SHELL COMPONENT IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P060028|S011|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/08/2015|||OK30|CHANGE TO USE SEGREGATION BASKETS FOR IN-PROCESS SHELL COMPONENT IN THE PRODUCTION OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P020004|S113|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2015|05/07/2015|||OK30|BOXING PROCESS CHANGE IN WHICH THE IFU PACKET IS PLACED IN THE PRODUCT BOX PRIOR TO STERILIZATION.
P020050|S022|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/05/2015|||OK30|QUALIFY AN ALTERNATE SUPPLIER FOR CALIBRATION TARGETS USED FOR THE WAVELIGHT EX500 LASER SYSTEM.
P030008|S020|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 LASER SYSTEM|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/05/2015|||OK30|QUALIFY AN ALTERNATE SUPPLIER FOR CALIBRATION TARGETS USED FOR THE WAVELIGHT EX500 LASER SYSTEM.
P050037|S058|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/06/2015|||OK30|AUTOMATION OF THE FINAL PACKAGING OF THE RADIESSE PRODUCT.
P050052|S064|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE AND RADIESSE(+)|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/06/2015|||OK30|AUTOMATION OF THE FINAL PACKAGING OF THE RADIESSE PRODUCT.
P920048|S009|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|RAPID FFN FOR THE TLIIQ SYSTEM|LKV|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/09/2015|06/24/2015|||APPR|APPROVAL FOR THE USE OF A NEW RESIN IN THE PLASMA FIBRONECTIN (PFN) AFFINITY COLUMN USED TO PURIFY THE A120 FETAL FIBRONECTIN SPECIFIC ANTIBODY CONTAINED IN THE RAPID FFN TEST FOR THE TLIIQ SYSTEM. ADDITIONALLY, THE IMPLEMENTATION OF A MODIFIED ARGININE CONTAINING NEUTRALIZATION BUFFER TO DECREASE PRECIPITATION OF THE A120 ANTIBODY FROM THE BUFFER.
N18033|S077|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/05/2015|||OK30|IMPLEMENT AN ALTERNATE SUPPLIER FOR THE CURE BULB USED IN THE MANUFACTURE OF VISTAKON® (ETAFILCON A) AND VISTAKON® (SENOFILCON A) BRAND CONTACT LENSES.
P040045|S051|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/05/2015|||OK30|IMPLEMENT AN ALTERNATE SUPPLIER FOR THE CURE BULB USED IN THE MANUFACTURE OF VISTAKON® (ETAFILCON A) AND VISTAKON® (SENOFILCON A) BRAND CONTACT LENSES.
P050028|S046|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/08/2015|||OK30|CHANGE IN SUPPLIER FOR A COMPONENT USED IN THE PRODUCTION OF COBAS TAQMAN ANALYZERS.
P060030|S047|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/08/2015|||OK30|CHANGE IN SUPPLIER FOR A COMPONENT USED IN THE PRODUCTION OF COBAS TAQMAN ANALYZERS.
P110037|S021|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/09/2015|05/08/2015|||OK30|CHANGE IN SUPPLIER FOR A COMPONENT USED IN THE PRODUCTION OF COBAS TAQMAN ANALYZERS.
P020011|S008|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|APTIMA HCV RNA QUALITATIVE ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2015|05/08/2015|||OK30|QUALIFICATION AND INTRODUCTION OF A NEW MANUFACTURING FILLING SYSTEM.
P040043|S073|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2015|05/07/2015|||OK30|IMPLEMENT AN OPTIONAL GRAFT WRAPPER MACHINE.
P130013|S001|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY|NGV|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/10/2015|11/21/2016|||APPR|
P130005|S008|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEM (OAS)|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/10/2015|06/25/2015|||APPR|APPROVAL TO CHANGE THE BLACK COLORANT USED IN THE ON/OFF BUTTON OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE.
P030017|S222|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice||N|04/10/2015|05/04/2015|||OK30|ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
P130007|S003|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/10/2015|10/30/2015|||APPR|APPROVAL FOR A CHANGE TO THE MANUFACTURING LOCATION AND PROCESS FOR SPRAY PAINT COATING OF THE ANIMAS VIBE INSULIN PUMP OUTER PLASTIC BASE AND COVER. THE ANIMAS VIBE INSULIN PUMP IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.
P910018|S017|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/2015|07/15/2015|||APPR|APPROVAL FOR A MODIFICATION OF THE INDICATIONS FOR USE OF THE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIPOSORBER® LA-15 SYSTEM AND IS INDICATED FOR USE IN PERFORMING LOW DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) APHERESIS TO ACUTELY REMOVE LDL-C FROM THE PLASMA OF THE FOLLOWING HIGH RISK PATIENT POPULATIONS FOR WHOM DIET HAS BEEN INEFFECTIVE AND MAXIMUM DRUG THERAPY HAS EITHER BEEN INEFFECTIVE OR NOT TOLERATED: 1) GROUP A  FUNCTIONAL HYPERCHOLESTEROLEMIC HOMOZYGOTES WITH LDL-C > 500 MG/DL; 2) GROUP B  FUNCTIONAL HYPERCHOLESTEROLEMIC HETEROZYGOTES WITH LDL-C >= 300 MG/DL; AND 3) GROUP C  FUNCTIONAL HYPERCHOLESTEROLEMIC HETEROZYGOTES WITH LDL-C >= 160 MG/DL AND DOCUMENTED CORONARY HEART DISEASE.
P100034|S013|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)|NZK|NE|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/10/2015|10/05/2015|15M-4015|11/02/2015|APPR|APPROVAL FOR THE OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM). THIS DEVICE IS INDICATED AS A TREATMENT FOR ADULT PATIENTS (22 YEARS OF AGE OR OLDER) WITH HISTOLOGICALLY-CONFIRMED GLIOBLASTOMA MULTIFORME (GBM). OPTUNE WITH TEMOZOLOMIDE IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED, SUPRATENTORIAL GLIOBLASTOMA FOLLOWING MAXIMAL DEBULKING SURGERY AND COMPLETION OF RADIATION THERAPY TOGETHER WITH CONCOMITANT STANDARD OF CARE CHEMOTHERAPY. OPTUNE WAS PREVIOUSLY APPROVED IN 2011 FOR THE TREATMENT OF RECURRENT GBM WITH THE FOLLOWING INDICATIONS FOR USE (IFU): OPTUNE IS INDICATED FOLLOWING HISTOLOGICALLY-OR RADIOLOGICALLY-CONFIRMED RECURRENCE IN THE SUPRA-TENTORIAL REGION OF THE BRAIN AFTER RECEIVING CHEMOTHERAPY. THE DEVICE IS INTENDED TO BE USED AS A MONOTHERAPY, AND IS INTENDED AS AN ALTERNATIVE TO STANDARD MEDICAL THERAPY FOR GBM AFTER SURGICAL AND RADIATION OPTIONS HAVE BEEN EXHAUSTED.
P920047|S078|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II/ II HTD, BLAZER PRIME HTD SYSTEM CABLES|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2015|04/23/2015|||OK30|ACCEPTANCE OF A NEW TRACEABILITY AND TRACKING SYSTEM AT THE SAN JOSE, CALIFORNIA LOCATION.
P020025|S069|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP, BLAZER PRIME XP, INTELLATIP MIFI XP SYSTEM CABLES|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2015|04/23/2015|||OK30|ACCEPTANCE OF A NEW TRACEABILITY AND TRACKING SYSTEM AT THE SAN JOSE, CALIFORNIA LOCATION.
P980003|S058|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED CATHETER ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2015|04/23/2015|||OK30|ACCEPTANCE OF A NEW TRACEABILITY AND TRACKING SYSTEM AT THE SAN JOSE, CALIFORNIA LOCATION.
P040037|S077|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2015|05/07/2015|||OK30|IMPLEMENT THE USE OF NEW EQUIPMENT FOR ONE OF YOUR DELIVERY SYSTEM COMPONENTS.
P130006|S016|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN  ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2015|05/07/2015|||OK30|IMPLEMENT THE USE OF NEW EQUIPMENT FOR ONE OF YOUR DELIVERY SYSTEM COMPONENTS.
P120020|S008|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2015|05/12/2015|||OK30|MOVE THE ENDOTOXIN TESTING PRIOR TO STERILIZATION.
P000058|S059|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE(R) BONE GRAFT|NEK|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/2015|12/04/2015|||APPR|APPROVAL FOR EXPANSION OF THE APPROVED INDICATIONS FOR USE OF INFUSE BONE GRAFT TO INCLUDE IMPLANTATION WITH TWO ADDITIONAL INTERBODY FUSION DEVICES, THE PERIMETER INTERBODY FUSION DEVICE OR THE CLYDESDALE SPINAL SYSTEM, UTILIZING SELECT OPEN SURGICAL PROCEDURES IN CONJUNCTION WITH SUPPLEMENTAL SPINAL FIXATION HARDWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE BONE GRAFT/ MEDTRONIC INTERBODY FUSION DEVICE AND IS INDICATED FOR:SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR GRADE 1 RETROLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE.  THE FOLLOWING INTERBODY DEVICES AND SURGICAL APPROACHES MAY BE USED WITH INFUSE BONE GRAFT:1) THE LT-CAGE LUMBAR TAPERED FUSION DEVICE, IMPLANTED VIA AN ANTERIOR OPEN OR AN ANTERIOR LAPAROSCOPIC APPROACH AT A SINGLE LEVEL;  2) THE INTER FIX OR INTER FIX RP THREADED FUSION DEVICE, IMPLANTED VIA AN ANTERIOR OPEN APPROACH AT A SINGLE LEVEL; 3)  THE PERIMETER INTERBODY FUSION DEVICE IMPLANTED VIA A RETROPERITONEAL ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT A SINGLE LEVEL FROM L2-S1OR AN OBLIQUE LATERAL INTERBODY FUSION (OLIF) APPROACH AT A SINGLE LEVEL FROM L5-S1; AND 4) THE CLYDESDALE SPINAL SYSTEM, IMPLANTED VIA AN OLIF APPROACH AT A SINGLE LEVEL FROM L2-L5.¿
P890003|S330|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK® MONITOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P030017|S223|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPECTRA TM SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2015|05/11/2015|||OK30|PROCESS CHANGE.
P820003|S134|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|SYMBIOS IPG AND SYNERGYST IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P850051|S083|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACTIVITRAX II IPG, ACTIVITRAX IPG, LEGEND II IPG,LEGEND IPG,MICRO MINIX,MINIX,MINIXST IPGS,PREMIER IPG,PREVAIL IPG, VITA|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P980035|S421|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, APPLICATION SOFTWARE,AT500 DDDRP PACING|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P980050|S099|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|APPLICATION SOFTWARE AND JEWEL AF ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P100026|S032|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2015|09/09/2015|||APPR|APPROVAL FOR AN ADDITIONAL DRYING OVEN.
P080011|S037|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2015|05/21/2015|||OK30|VALIDATION OF LINE #11 FOR MANUFACTURING BIOFINITY TORIC(COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES.
P010015|S271|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|APPLICATION SOFTWARE, CONSULTA CRT-P, INSYNC IPG, SYNCRA CRT-P AND VIVA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P130026|S004|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2015|05/02/2015|||APPR|APPROVAL FOR PROCESS CHANGES TO THE TACTICATH QUARTZ CATHETER DISTAL PULLWIRE ASSEMBLY.
P900061|S134|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|APPLICATION SOFTWARE, MEDTRONIC GEM ICD, MEDTRONIC JEWEL ICD, MEDTRONIC JEWEL PLUS ICD, MEDTRONIC MICRO JEWEL ICD,MEDTRO|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P920015|S152|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PCD, TACHYARRHYTHMIA CONTROL SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P930022|S018|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LEGEND PLUS IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P970012|S097|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|APPLICATION SOFTWARE, KAPPA 400 DR IPG AND KAPPA 400 SR IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P980016|S537|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|APPLICATION SOFTWARE, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD,GEM I|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P990001|S120|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|APPLICATION SOFTWARE, PROVIT SOFTWARE, VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P100021|S047|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT II STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYSTEM|MIH|CV|Special (Immediate Track)||N|04/14/2015|05/06/2015|||APPR|APPROVAL FOR INTRODUCING A LAMP MANDREL AS A MANUFACTURING TOOL FOR THE INSPECTION OF THE RADIOPAQUE CONTRALATERAL GATE MARKER DURING THE MARKER ATTACHMENT PROCESS.
P010031|S500|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Programmer, pacemaker|APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC|KRG|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P090013|S184|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|APPLICATION SOFTWARE, REVO MRI IPG AND SOFTWARE|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2015|06/04/2015|||APPR|APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
P130009|S034|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/15/2015|10/09/2015|15M-4017|11/03/2015|APPR|APPROVAL FOR THE SAPIEN XT TRANSCATHETER HEART VALVE, MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO EITHER SEVERE NATIVE CALCIFIC AORTIC STENOSIS OR FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC VALVE WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >8% OR AT A >15% RISK OF MORTALITY AT 30 DAYS).
P880086|S256|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAKER DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2015|05/14/2015|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF LOW VOLTAGE HYBRID ASSEMBLIES.
P030035|S134|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2015|05/14/2015|||OK30|ADDITION OF AN ALTERNATE SUPPLIER OF LOW VOLTAGE HYBRID ASSEMBLIES.
P110014|S005|DUNE MEDICAL DEVICES INC|111 SPEEN ST SUITE 101||FRAMINGHAM|MA|01701||Diagnostic low electric field|MARGINPROBE SYSTEM|OEE|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2015|05/18/2015|||OK30|TWO CHANGES TO THE CALIBRATION PROBE CONTROL (CPC) AND SENSOR SUB-ASSEMBLIES IN THE MARGINPROBE SYSTEM
P050023|S087|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4)|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2015|12/21/2015|||APPR|APPROVAL FOR THE PROMRI FULL BODY SCAN ICD SYSTEM.
P950037|S151|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|LINOX SMART(S65)(SD65/18)(SDX65/15&65/17),PROTEGO DF-1(S65)(SD65/18)(DX65/15&65/17),PROTEGO(S65&75)(SD65/16,65/18,75/18)|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2015|12/21/2015|||APPR|APPROVAL FOR THE PROMRI FULL BODY SCAN ICD SYSTEM.
P000009|S063|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROGRAMMER SOFTWARE(1503.U) FOR ICS 3000/RENAMIC PROGRAMMERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2015|12/21/2015|||APPR|APPROVAL FOR THE PROMRI FULL BODY SCAN ICD SYSTEM.
P070008|S063|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|PROGRAMMER SOFTWARE (1503.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2015|12/21/2015|||APPR|APPROVAL FOR THE PROMRI FULL BODY SCAN ICD SYSTEM.
P950037|S152|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|CARDIOMESSENGER, RELIATY, RENAMIC, REOCOR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2015|05/14/2015|||OK30|ADDITION OF A NEW SUPPLIER FOR PRINTED CIRCUIT BOARDS.
P050023|S088|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIOMESSENGER|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2015|05/14/2015|||OK30|ADDITION OF A NEW SUPPLIER FOR PRINTED CIRCUIT BOARDS.
P010013|S063|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/16/2015|06/15/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: TO INCREASE IN NUMBER OF STUDY SITES.
P980035|S422|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2015|05/14/2015|||OK30|UPDATED BIOBURDEN TEST METHODS FOR THE IMPLANTABLE PULSE GENERATOR AND LEAD MODELS FOR THE DEVICES.
P830061|S120|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2015|05/14/2015|||OK30|UPDATED BIOBURDEN TEST METHODS FOR THE IMPLANTABLE PULSE GENERATOR AND LEAD MODELS FOR THE DEVICES.
P090013|S185|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2015|05/14/2015|||OK30|UPDATED BIOBURDEN TEST METHODS FOR THE IMPLANTABLE PULSE GENERATOR AND LEAD MODELS FOR THE DEVICES.
P930039|S128|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/16/2015|05/14/2015|||OK30|UPDATED BIOBURDEN TEST METHODS FOR THE IMPLANTABLE PULSE GENERATOR AND LEAD MODELS FOR THE DEVICES.
P030017|S224|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/07/2015|||OK30|UPDATE TEST EQUIPMENT SOFTWARE.
P010015|S272|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P930029|S051|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONTACTR,RF ENHANCR II,RF CONDUCTR,RF MARINR 5F,RF MARINR 7FR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P930039|S129|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P950024|S064|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P890003|S331|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2 LEAD,PRODIGY IPG,SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P900061|S135|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|END CAP,EPICARDIAL PATCH LEAD ,UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P920015|S153|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P980016|S538|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P850089|S114|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P830061|S121|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P090013|S186|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD, REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P080006|S079|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P960016|S054|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/11/2015|||OK30|ACCEPTANCE OF A NEW MECHANIZED BRAZE PROCESS FOR THE LIVEWIRE TC ABLATION CATHETER.
P060039|S067|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P030036|S078|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ANCHORING SLEEVE KIT, SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P010031|S501|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P980035|S423|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P980050|S100|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/17/2015|05/04/2015|||OK30|USE OF A NEW ENTERPRISE SYSTEM USED IN CONJUNCTION WITH VARIOUS MANUFACTURING PROCESSES.
P970004|S197|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/20/2015|10/04/2016|||APPR|Approval for a labeling update to incorporate data from the now completed, randomized 6 month cohort (Phase I)  and 12 month data from the ongoing, nonrandomized study cohort (Phase II).
P080025|S092|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/20/2015|10/04/2016|||APPR|Approval for a labeling update to incorporate data from the now completed, randomized 6 month cohort (Phase I)  and 12 month data from the ongoing, nonrandomized study cohort (Phase II).
P080006|S080|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN PERFORMA|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2015|04/29/2015|||OK30|UPDATE TO THE PULL TEST SAMPLE SIZES AND CONTROL LIMITS.
P040014|S025|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2015|05/20/2015|||OK30|CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY.
P040042|S030|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 ABLATION CATHETER, THERAPY 8 MM THERMISTOR , SAFIRE TX ABLATION CATHETERS  & GENERATORS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2015|05/20/2015|||OK30|CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY.
P060019|S031|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH ABLATION CATHETERS (INCLUDING ALL BRAID MODELS)|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2015|05/20/2015|||OK30|CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY.
P110016|S017|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2015|05/20/2015|||OK30|CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY.
P130005|S009|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)|MCX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/20/2015|06/25/2015|||APPR|APPROVAL FOR AN UPDATE TO THE SEAL ON COMPONENTS OF THE ORBITAL ATHERECTOMY DEVICE (OAD).
P930039|S130|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/2015|06/22/2015|||APPR|APPROVAL FOR THE USE OF THE CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 MRI WITH THE ADVISA SR MRI A3SR01 IMPLANTABLE PULSE GENERATOR.
P980035|S424|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA SR IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/2015|06/22/2015|||APPR|APPROVAL FOR THE USE OF THE CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 MRI WITH THE ADVISA SR MRI A3SR01 IMPLANTABLE PULSE GENERATOR.
P110002|S011|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|THE MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/2015|01/27/2016|||APPR|APPROVAL FOR LARGER MOBI-C® ENDPLATE FOOTPRINTS.
P110009|S011|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|THE MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/2015|01/27/2016|||APPR|APPROVAL FOR LARGER MOBI-C® ENDPLATE FOOTPRINTS.
P960004|S068|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II PACE/SENSE LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2015|05/14/2015|||OK30|REPLACE THE PACE/SENSE LEAD ANODE INSULATOR TUBING HOLE DIAMETER VERIFICATION INSPECTION PROCESS WITH A VALIDATED MANUFACTURING PROCESS.
P090015|S003|Leica Biosystems|36 Cherry Hill Drive||Danvers|MA|01923||SYSTEM, TEST, HER-2/NEU, IHC|LEICA BOND ORACLE HER2 IHC SYSTEM|MVC|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/20/2015|05/20/2015|||APPR|APPROVAL FOR LABELLING CHANGES.
P120010|S066|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2015|05/15/2015|||OK30|INCREASE IN THE SHELF LIFE FOR THE ENLITE GLUCOSE SENSORSUBASSEMBLY (SENSOR BASE AND CAPS) AFTER PLASMA TREATMENT, AND AN INCREASE IN THE LOAD (NUMBER)OF TREATED ENLITE SENSOR SUBASSEMBLIES PER PLASMA TREATMENT CYCLE. THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P000037|S041|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/20/2015|06/19/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P140010|S006|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN-PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|04/21/2015|06/24/2015|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF THE PRODUCT FROM 12 TO 24 MONTHS.
P990023|S013|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2015|02/18/2016|||APPR|Approval for an alternate packaging configuration (syringe, rubber tip cap, pouch), change in the release specification for pH, and change in the release and stability specification for osmolality.
N970003|S173|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2015|05/19/2015|||OK30|MODIFY THE CRYSTAL OSCILLATOR MANUFACTURING PROCESS AT AN EXISTING SUPPLIER FOR THE DEVICES.
P130021|S014|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|COREVALVE (TM) EVOLUT(TM) R SYSTEM|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/23/2015|06/22/2015|||APPR|APPROVAL FOR A DESIGN ITERATION OF THE 23, 26, AND 29 MM MEDTRONIC COREVALVE SYSTEM. THE NEW COMPONENTS INCLUDE COREVALVE EVOLUT R TRANSCATHETER AORTIC VALVES, MODELS EVOLUTR-23-US, EVOLUTR-26-US, AND EVOLUTR-29-US, ENVEO R DELIVERY CATHETER SYSTEM, MODEL ENVEOR-US, AND ENVEO R LOADING SYSTEMS, MODELS LS-ENVEOR-23US AND LS-ENVEOR-2629US. THESE COMPONENTS WILL BE MARKETED UNDER THE TRADE NAME COREVALVE EVOLUT R SYSTEM.
P030005|S120|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2015|05/19/2015|||OK30|MODIFY THE CRYSTAL OSCILLATOR MANUFACTURING PROCESS AT AN EXISTING SUPPLIER FOR THE DEVICES.
P010029|S024|FERRING PHARMACEUTICALS, INC.|100 INTERPACE PARKWAY||PARSIPPANY|NJ|07054||Acid, hyaluronic, intraarticular|EUFLEXXA (1% SODIUM HYALURONATE)|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/23/2015|05/07/2015|||OK30|SCALE UP THE MANUFACTURING PROCESS OF EUFLEXXA BY INCREASING THE FORMULATION CAPACITY.
P950009|S019|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT SLIDE PROFILER|MNM|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2015|07/23/2015|||APPR|APPROVAL FOR A REPLACEMENT WORKSTATION AND SOFTWARE MODIFICATIONS FOR THE BD FOCALPOINT SLIDE PROFILER.
P850022|S024|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO|LOF|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2015|07/15/2015|||APPR|APPROVAL FOR A CHANGE IN THE CONDUCTOR OF THE PATIENT LEAD CABLE, BIOMET PN 1067724-().
N970003|S174|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS|LWP|CV|30-Day Notice||N|04/24/2015|05/19/2015|||OK30|MODIFY THE CRYSTAL OSCILLATOR MANUFACTURING PROCESS FOR THE PULSE GENERATOR DEVICES AT AN EXISTING SUPPLIER.
P030005|S121|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE  CRT-P|NKE|CV|30-Day Notice||N|04/24/2015|05/19/2015|||OK30|MODIFY THE CRYSTAL OSCILLATOR MANUFACTURING PROCESS FOR THE PULSE GENERATOR DEVICES AT AN EXISTING SUPPLIER.
P940015|S034|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC, SYNVISC-ONE|MOZ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|04/24/2015|07/24/2015|||APPR|APPROVAL FOR THE FOLLOWING CHANGES FOR THE DELIVERY SYRINGES FOR SYNVISC® AND SYNVISC-ONE®:1) CHANGE OF THE CLEAR PLASTIC RIGID TIP CAP (PRTC) TO A BLUE PRTC;2) CHANGE OF THE CLEAR POLYSTYRENE PLUNGER ROD, WITH DIAMETERS OF 8.0 MM AND 13.4 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A BLUE POLYPROPYLENE PLUNGER ROD WITH DIAMETERS OF 8.2 MM AND 13.7 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 3) CHANGE OF THE THUMB PRESS ON THE PLUNGER ROD FROM A FLAT, SMOOTH SURFACE WITH DIAMETERS OF 12.7 MM AND 18.6 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A FLAT, TEXTURED SURFACE WITH DIAMETERS OF 19 MM AND 26.7 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 4) CHANGE OF THE GREY PROPYLENE OVAL-SHAPED FINGER FLANGE, WITH OVERALL WIDTHS OF 28.4 MM AND 43.8 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A BLUE PROPYLENE WING-SHAPED FINGER FLANGE, WITH OVERALL WIDTHS OF 35.6 MM AND 43.9 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 5) CHANGE OF THE TRANSPARENT SYRINGE LABEL TO A TRANSLUCENT SYRINGE LABEL WITH GRADED BLUE COLOR; AND6) CHANGE OF THE SYNVISC-ONE® BLISTER TRAY TO INCORPORATE A FINGER FLANGE CAVITY MODIFIED TO ACCOMMODATE THE NEW FLANGE DESIGN.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNVISC® AND SYNVISC-ONE® AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G. ACETAMINOPHEN.
P030047|S030|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL  STENT SYSTEMS|NIM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2015|01/04/2016|||APPR|APPROVAL FOR REPLACEMENT OF A RAW MATERIAL SUPPLIER.
P980018|S019|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEP TEST|MVC|PA|30-Day Notice||N|04/27/2015|05/21/2015|||OK30|MODIFY THE IN PROCESS QUALITY CONTROL (IPC) TEST TO VERIFY THE PERFORMANCE OF BULK REAGENTS (INTERMEDIATES) DAB+ BUFFERED SUBSTRATE AND DAB+ CHROMOGEN.
P020004|S114|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2015|05/27/2015|||OK30|REVISED DESTRUCTIVE TESTING SAMPLING PLAN FOR C3 DELIVERY CATHETERS.
P910077|S149|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Pacemaker/icd/crt non-implanted components|LATITUDE NXT PATIENT MANAGEMENT SYSTEM|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2015|07/21/2015|||APPR|APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
P960040|S345|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN ICDS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2015|07/21/2015|||APPR|APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
P010012|S387|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Pacemaker/icd/crt non-implanted components|COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2015|07/21/2015|||APPR|APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
P030005|S122|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE,INTUA,VISIONIST,VALITUDE CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2015|07/21/2015|||APPR|APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
P110042|S045|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM SUBCUTANEOUS ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2015|07/21/2015|||APPR|APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
N970003|S175|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO,INGENIO,VITALIO,FORMIO,ESSENTIO,ACCOLADE,PROPONENT PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/27/2015|07/21/2015|||APPR|APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
P920047|S079|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD, BLAZER PRIME HTD|LPB|CV|30-Day Notice||N|04/28/2015|05/11/2015|||OK30|ACCEPTANCE OF NEW MONITORING EQUIPMENT IN THE MICROBIOLOGY LAB AT THE HEREDIA, COSTA RICA LOCATION.
P020025|S070|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP, BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS|OAD|CV|30-Day Notice||N|04/28/2015|05/11/2015|||OK30|ACCEPTANCE OF NEW MONITORING EQUIPMENT IN THE MICROBIOLOGY LAB AT THE HEREDIA, COSTA RICA LOCATION.
P120020|S009|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2015|07/24/2015|||APPR|APPROVAL FOR NEW INTERMEDIATE PRODUCT SIZES.APPROVAL FOR NEW INTERMEDIATE PRODUCT SIZES.
P010030|S061|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/29/2015|||OK30|ADD NAMSCO AS AN APPROVED SUPPLIER FOR THE DISTRIBUTION NODEBASE COMPONENT.
P860004|S227|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/18/2015|||OK30|REPLACE THE LEGACY SYSTEMS USED AT THE FIRM¿S PUERTO RICO FACILITIES WITH A NEWER, STATE-OF-THE ART SYSTEM.
P100045|S005|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF SYSTEM|MOM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/22/2015|||OK30|ALTERNATE SUPPLIER FOR SKIVING, TIPPING, COATING, HUB BOND, AND HUB ASSEMBLY TASKS PERFORMED IN MANUFACTURING THE PA DELIVERY CATHETER.
P840001|S300|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/18/2015|||OK30|REPLACE THE LEGACY SYSTEMS USED AT THE FIRM¿S PUERTO RICO FACILITIES WITH A NEWER, STATE-OF-THE ART SYSTEM.
P970004|S198|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/18/2015|||OK30|REPLACE THE LEGACY SYSTEMS USED AT THE FIRM¿S PUERTO RICO FACILITIES WITH A NEWER, STATE-OF-THE ART SYSTEM.
P940015|S035|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/26/2015|||OK30|ADDITION OF A FILTRATION STEP IN THE MANUFACTURING PROCESS FOR SYNVISC/SYNVISC-ONE (HYLAN G-F20).
P080025|S093|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/18/2015|||OK30|REPLACE THE LEGACY SYSTEMS USED AT THE FIRM¿S PUERTO RICO FACILITIES WITH A NEWER, STATE-OF-THE ART SYSTEM.
P890064|S032|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS|MAQ|MI|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/29/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN PENANG, MALAYSIA.
P050047|S047|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/22/2015|||OK30|CHANGING THE MANUAL VISUAL INSPECTION PROCESS TO AN AUTOMATED VISUAL INSPECTION PROCESS FOR THE 1.0 ML SYRINGES.
P110033|S014|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/22/2015|||OK30|CHANGING THE MANUAL VISUAL INSPECTION PROCESS TO AN AUTOMATED VISUAL INSPECTION PROCESS FOR THE 1.0 ML SYRINGES.
P960009|S225|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2015|05/18/2015|||OK30|REPLACE THE LEGACY SYSTEMS USED AT THE FIRM¿S PUERTO RICO FACILITIES WITH A NEWER, STATE-OF-THE ART SYSTEM.
P920047|S080|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II HTD TEMPERATURE ABLATION CATHETER|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/29/2015|05/29/2015|||APPR|APPROVAL TO ADD AN ADDITIONAL ADVERSE EVENT TO THE DIRECTIONS FOR USE (DFU) WARNING SECTION.
P900056|S146|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|05/28/2015|||OK30|UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
P920047|S081|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|05/28/2015|||OK30|UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
P980003|S059|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|05/28/2015|||OK30|UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
P020025|S071|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|05/28/2015|||OK30|UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
P060006|S067|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|05/28/2015|||OK30|UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
P100023|S115|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|05/28/2015|||OK30|UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
P950037|S153|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SELOX SR 45,SELOX SR 53,SELOX SR 60,SELOX JT 45,SELOX JT 53,SELOX ST 53,SELOX ST 60,SETROX S 45,SETROX S 53,SETROX S 60,|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|01/28/2016|||APPR|APPROVAL FOR AN ALTERNATIVE DRUG ELUTION METHOD FOR STEROID LEADS.
P980023|S066|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|PROTEGO SD 60/16,PROTEGO SD 65/16,PROTEGO SD 75/18,PROTEGO S 60,PROTEGO S 65,PROTEGO S 75,PROTEGO T 65,PROTEGO TD 65/16,|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|01/28/2016|||APPR|APPROVAL FOR AN ALTERNATIVE DRUG ELUTION METHOD FOR STEROID LEADS.
P120010|S067|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Sensor, glucose, invasive|ENLITE SENSOR|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/29/2015|07/29/2015|||APPR|APPROVAL FOR A DESIGN CHANGE TO THE ENLITE SENSOR BASE COMPONENT OF THE ENLITE SENSOR.
P050023|S089|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|COROX OTW 75 UP STEROID, COROX OTW 85 UP STEROID|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|01/28/2016|||APPR|APPROVAL FOR AN ALTERNATIVE DRUG ELUTION METHOD FOR STEROID LEADS.
P110010|S106|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM/PROMUS PREMIER EVEROLIMUS-ELUTING CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|05/28/2015|||OK30|UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
P070008|S064|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CELERITY 2D 75, CELERITY 2D 85,CELERITY 3D 75, CELERITY 3D 85, CELERITY PILOT 75, CELERITY PILOT 85, COROX OTW-L 75-BP,|NKE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|01/28/2016|||APPR|APPROVAL FOR AN ALTERNATIVE DRUG ELUTION METHOD FOR STEROID LEADS.
P130030|S012|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2015|05/28/2015|||OK30|UPDATE TO SOFTWARE AND VACUUM PUMP SETTINGS USED IN YOUR STERILIZATION CHAMBER.
P130007|S004|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/30/2015|12/24/2015|16M-0120|02/12/2016|APPR|APPROVAL FOR THE ANIMAS VIBE SYSTEM. THE ANIMAS® VIBE SYSTEM CONSISTS OF THE ANIMAS VIBE INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM CGM SENSOR AND TRANSMITTER.THE ANIMAS VIBE INSULIN PUMP IS INTENDED FOR THE CONTINUOUS SUBCUTANEOUS INFUSION OF INSULIN FOR THE MANAGEMENT OF INSULIN-REQUIRING DIABETES. IT CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY OR AS PART OF THE ANIMAS VIBE SYSTEM TO RECEIVE AND DISPLAY CONTINUOUS GLUCOSE MEASUREMENTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER.  THE ANIMAS VIBE SYSTEMS CONTINUOUS GLUCOSE MONITORING (CGM) IS INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 2 AND OLDER) WITH DIABETES, AND IS INTENDED TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. CGM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF RESULTS FROM THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.THE ANIMAS VIBE SYSTEM IS INTENDED FOR SINGLE PATIENT USE IN PERSONS AGE 2 AND OLDER AND REQUIRES A PRESCRIPTION.
P960009|S226|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2015|05/18/2015|||OK30|CHANGES TO THE FINAL FUNCTION ELECTRICAL CONTINUITY TEST FOR LEADS.
P080006|S081|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEAD|OJX|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/30/2015|06/29/2015|||APPR|APPROVALTO THE POST-APPROVAL STUDY TO CLOSE ENROLLMENT OF THE MODEL 4396 PAS UPON COMPLETION OF THE INTERIM ANALYSIS, WHICH WILL BE INCLUDED WITHIN THE 54 MONTH PROGRESS REPORT.
P020004|S115|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2015|05/27/2015|||OK30|IMPLEMENT AN ADDITIONAL PACKAGING LOCATION.
P080015|S012|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|CERVISTA HPV 16/18 ASSAY|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2015|05/29/2015|||OK30|ADDITIONAL MANUFACTURING SITE FOR OLIGONUCLEOTIDE COMPONENTS.
P040027|S042|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/30/2015|05/27/2015|||OK30|IMPLEMENT AN ADDITIONAL PACKAGING LOCATION.
P040047|S040|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE|LNM|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2015|11/12/2015|||APPR|APPROVAL FOR ADJUSTMENTS OF THE STANDARD CURVE RANGE FOR ENDOTOXIN TESTING OF THE COAPTITE AND RADIESSE PRODUCTS.
P130029|S002|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|FLUENCY PLUS ENDOVASCULAR STENT GRAFT|PFV|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2015|04/26/2016|16M-1223|05/12/2016|APPR|Approval for the Fluency Plus Endovascular Stent Graft.  This device is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (AV) fistula or AV graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an AV graft.
P050037|S059|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2015|11/12/2015|||APPR|APPROVAL FOR ADJUSTMENTS OF THE STANDARD CURVE RANGE FOR ENDOTOXIN TESTING OF THE COAPTITE AND RADIESSE PRODUCTS.
P050052|S065|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, RADIESSE (+)|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2015|11/12/2015|||APPR|APPROVAL FOR ADJUSTMENTS OF THE STANDARD CURVE RANGE FOR ENDOTOXIN TESTING OF THE COAPTITE AND RADIESSE PRODUCTS.
P010019|S039|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2015|05/28/2015|||OK30|IMPLEMENTATION OF MODIFICATIONS TO THE PACKAGING AND QUALITY CONTROL TESTING OF A RAW MATERIAL.
P020036|S034|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|CORDIS SMART AND SMART CONTROL NITINOL STENT SYSTEMS VARIOUS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2015|05/28/2015|||OK30|USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.
P120002|S010|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|CORDIS SMART AND SMART CONTROL VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2015|05/28/2015|||OK30|USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.
P030056|S009|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA Centaur® HCV assay|MZO|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/01/2015|09/09/2016|||APPR|Approval for the migration of the ADVIA Centaur® HCV (aHCV) to the ADVIA Centaur® XPT system.
P030047|S031|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL STENT SYSTEMS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2015|05/28/2015|||OK30|USE AN ALTERNATE STABILIZING ADDITIVE IN PLASTIC COMPOUNDING PROCESSES.
P120010|S068|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/01/2015|07/22/2015|||APPR|CHANGE IN THE SUPPLIER OF HUMAN SERUM ALBUMIN (HSA) SOLUTION USED IN THE MANUFACTURE OF THE ENLITE GLUCOSE SENSOR. ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P100009|S012|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETER|NKM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/04/2015|07/23/2015|||APPR|APPROVAL TO ADD A ONE-WAY ACTUATOR TO THE MITRACLIP DELIVERY SYSTEM CATHETER HANDLE.
P040037|S079|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2015|06/02/2015|||OK30|CHANGE IN THE HEAT TREATMENT MANUFACTURING PROCEDURE, THE USE OF A NEW CONTAINER CLOSURE SYSTEM, AS WELL AS THE ADDITION OF TWO SUPPLIERS FOR A PROCESSING AID.
P130006|S018|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2015|06/02/2015|||OK30|CHANGE IN THE HEAT TREATMENT MANUFACTURING PROCEDURE, THE USE OF A NEW CONTAINER CLOSURE SYSTEM, AS WELL AS THE ADDITION OF TWO SUPPLIERS FOR A PROCESSING AID.
P120006|S020|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION IX ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/04/2015|07/17/2015|||APPR|APPROVAL FOR CHANGES TO THE AORTIC BODY DELIVERY CATHETER.
P030017|S226|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2015|05/29/2015|||OK30|PROCESS CHANGES FOR THE NICKEL STRIPS IN THE IPG BATTERY.
N12159|S034|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FAMILY OF ABSORBABLE HEMOSTATS|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2015|06/04/2015|||OK30|EXPANSION OF THE CLEAN MANUFACTURING ENVIRONMENT (CME) AREA AT THE ETHICON, LLC. SAN LORENZO MANUFACTURING FACILITY.
P040027|S043|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2015|06/03/2015|||OK30|USE OF AN ALTERNATE POWDER TO COAT THE STENT FRAME.
P100026|S033|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/05/2015|06/30/2015|||APPR|APPROVAL FOR A POST-APPROVAL STUDY PROTOCOL.
P080020|S014|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/05/2015|08/03/2015|||APPR|APPROVAL FOR REVISIONS TO THE PACKAGE INSERT AND THE PATIENT INFORMATION FOR GEL-ONE® AS FOLLOWS: 1) REVISION OF THE STATEMENT, THE SAFETY AND EFFECTIVENESS OF A REPEAT TREATMENT CYCLE OF GEL-ONE® HAVE NOT BEEN ESTABLISHED. TO THE STATEMENT, THE EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF GEL-ONE® HAS NOT BEEN ESTABLISHED; AND 2) CITATION OF CLINICAL STUDY DATA FOR RETREATMENT WITH GEL-ONE® IN SUPPORT OF THE REVISION OF THIS STATEMENT AS DESCRIBED ABOVE.
P090024|S001|SIEMENS HEALTHCARE DIAGNOSTICS|511 Benedict Avenue||Tarrytown|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HEPATITIS B E ANTIGEN ASSAY|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/05/2015|10/18/2016|||APPR|Approval for the migration of the ADVIA Centaur® HBeAg Assay (ADVIA Centaur® HBeAg Assay and ADVIA Centaur® HBeAg Quality Control Material) to the ADVIA Centaur® XPT system.
P050052|S066|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE (+) 0.8CC, RADIESSE (+) 1.5CC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2015|06/03/2015|||OK30|INCREASE OF THE MAXIMUM BATCH SIZE USING EXISTING EQUIPMENT, AND IMPLEMENTATION OF A NEW MIXING BLADE OPERATED AT A LOWER SPEED.
P100026|S034|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/06/2015|06/30/2015|||APPR|APPROVAL FOR A POST-APPROVAL STUDY PROTOCOL.
P950005|S057|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ELECTROPHYSIOLOGY CATHETER,|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2015|06/02/2015|||OK30|ACCEPTANCE OF A SUPPLIER MANUFACTURING SITE CHANGE FOR VACUUM-FORMED PLASTIC TRAY COMPONENTS.
P990025|S046|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2015|06/02/2015|||OK30|ACCEPTANCE OF A SUPPLIER MANUFACTURING SITE CHANGE FOR VACUUM-FORMED PLASTIC TRAY COMPONENTS.
P010068|S047|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CATHETER, PERCUTANEOUS, CARDIAC ABLATION  NAVISTAR DS ELECTROPHYSIOLOGY CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2015|06/02/2015|||OK30|ACCEPTANCE OF A SUPPLIER MANUFACTURING SITE CHANGE FOR VACUUM-FORMED PLASTIC TRAY COMPONENTS.
P030031|S068|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CATHETER, PERCUTANEOUS, CARDIAC ABLATION  CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2015|06/02/2015|||OK30|ACCEPTANCE OF A SUPPLIER MANUFACTURING SITE CHANGE FOR VACUUM-FORMED PLASTIC TRAY COMPONENTS.
P970051|S130|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2015|12/04/2015|||APPR|APPROVAL FOR THE ADDITION OF AN ALTERNATIVE AUTOMATED ELECTRODE PAD CLEANING METHOD USING LASER ABLATION.
P060040|S042|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2015|06/04/2015|||OK30|IMPLEMENTATION OF  A SUPPLIERS FACILITY RELOCATION FOR CERTAIN COMPONENTS OF THE THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM AND THORATEC VENTRICULAR ASSIST DEVICE SYSTEM.
P990055|S015|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)|ADVIA CENTAUR CPSA ASSAY|NAF|IM|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/2015|10/24/2016|||APPR|Approval for the migration of the ADVIA Centaur cPSA assay to the ADVIA Centaur XPT system
P870072|S060|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2015|06/04/2015|||OK30|IMPLEMENTATION OF  A SUPPLIERS FACILITY RELOCATION FOR CERTAIN COMPONENTS OF THE THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM AND THORATEC VENTRICULAR ASSIST DEVICE SYSTEM.
P930038|S076|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2015|06/04/2015|||OK30|REDUCTION IN THE LOWER SHIPMENT TEMPERATURE LIMIT FOR ANGIO-SEAL PRODUCT TRANSPORTATION TO AND FROM THE STERILIZER.
P980041|S032|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/2015|06/23/2015|||APPR|APPROVAL FOR LABELING CHANGES TO ALIGN WITH GLOBALLY HARMONIZEDSYSTEM OF CLASSIFICATION OF CHEMICALS (GHS) WHICH PROVIDES A CONSISTENT HAZARD CLASSIFICATION SYSTEM THAT IS RECOGNIZED GLOBALLY.
P970038|S031|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTG|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/2015|06/23/2015|||APPR|APPROVAL FOR LABELING CHANGES TO ALIGN WITH GLOBALLY HARMONIZEDSYSTEM OF CLASSIFICATION OF CHEMICALS (GHS) WHICH PROVIDES A CONSISTENT HAZARD CLASSIFICATION SYSTEM THAT IS RECOGNIZED GLOBALLY.
P850048|S041|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|MTF|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/2015|06/23/2015|||APPR|APPROVAL FOR LABELING CHANGES TO ALIGN WITH GLOBALLY HARMONIZEDSYSTEM OF CLASSIFICATION OF CHEMICALS (GHS) WHICH PROVIDES A CONSISTENT HAZARD CLASSIFICATION SYSTEM THAT IS RECOGNIZED GLOBALLY.
P090026|S015|BECKMAN COULTER, INC.|1000 LAKE HAZELTINE DR.||CHASKA|MN|55318||P2psa|ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|OYA|IM|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/07/2015|06/23/2015|||APPR|APPROVAL FOR LABELING CHANGES TO ALIGN WITH GLOBALLY HARMONIZEDSYSTEM OF CLASSIFICATION OF CHEMICALS (GHS) WHICH PROVIDES A CONSISTENT HAZARD CLASSIFICATION SYSTEM THAT IS RECOGNIZED GLOBALLY.
P130013|S002|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY|NGV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/07/2015|06/01/2015|||OK30|ADD THE WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY TO THE SCOPE OF THE MANUFACTURING EXECUTION SYSTEM.
P050047|S048|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2015|10/06/2015|||APPR|APPROVAL FOR AN IMPROVEMENT TO THE METHOD USED TO MEASURE HA CONTENT OF FINAL JUVÉDERM AND VOLUMA XC PRODUCTS DURING BATCH RELEASE.
P110033|S015|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2015|10/06/2015|||APPR|APPROVAL FOR AN IMPROVEMENT TO THE METHOD USED TO MEASURE HA CONTENT OF FINAL JUVÉDERM AND VOLUMA XC PRODUCTS DURING BATCH RELEASE.
N970003|S176|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMPLANTABLE PULSE GENERATOR (PG), ESSENTIO, PROPONENT, ACCOLADE, ALTRUA2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2015|05/31/2015|||OK30|ADD AN ALTERNATE SOURCE SUPPLIER FOR THE ANODE BATTERY RAW MATERIAL, STAINLESS STEEL RIBBON.
P030005|S123|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CARDIAC RESYNCHRONIZATION THERAPY -PACEMAKER (CRT P) VALITUDE: U125 AND U128|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2015|05/31/2015|||OK30|ADD AN ALTERNATE SOURCE SUPPLIER FOR THE ANODE BATTERY RAW MATERIAL, STAINLESS STEEL RIBBON.
P120005|S035|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2015|06/03/2015|||OK30|MODIFICATION TO THE TRANSMITTER (PART # 9438) HOLDING FIXTURE USED DURING MANUFACTURE OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM, DEXCOM G4 PLATINUM PEDIATRIC CGM SYSTEM, AND THE DEXCOM SHARE SYSTEM.
P120014|S005|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||Somatic gene mutation detection system|THXID BRAF KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/08/2015|06/05/2015|||OK30|CHANGE IN THE METHOD USED TO DETERMINE THE CONCENTRATION OF THE OLIGONUCLEOTIDES AND PROBES USED IN THE TEST KIT.
P120020|S010|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2015|06/10/2015|||OK30|ADD AN ALTERNATE ETHYLENE OXIDE STERILIZATION CYCLE AT THE CURRENTLY-APPROVED STERIGENICS FACILITY.
P050023|S090|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|BIOTRONIK ICD FAMILIES|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/11/2015|12/18/2015|||APPR|APPROVAL FOR CARDIOMESSENGER SMART MODEL 401831.
P110033|S016|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2015|06/10/2015|||OK30|CHANGES TO THE DIALYSIS AND HOMOGENIZATION STEPS DURING THE JUVEDERM VOLUMA XC MANUFACTURING PROCESS.
P840001|S301|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATIONS LEA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2015|06/08/2015|||OK30|TRANSFER OF INCOMING INSPECTION ACTIVITIES, FOR A NUMBER OF DEVICE COMPONENTS USED IN THE MANUFACTURE OF NEUROMODULATION LEADS, EXTENSIONS AND ACCESSORIES FROM THE MEDTRONIC RICE CREEK MANUFACTURING FACILITY TO MEDTRONIC PUERTO RICO OPERATION CNETERS (MPROC) IN VILLALBA AND JUNCOS.RANSFER OF INCOMING INSPECTION ACTIVITIES.
P960009|S227|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2015|06/08/2015|||OK30|TRANSFER OF INCOMING INSPECTION ACTIVITIES, FOR A NUMBER OF DEVICE COMPONENTS USED IN THE MANUFACTURE OF NEUROMODULATION LEADS, EXTENSIONS AND ACCESSORIES FROM THE MEDTRONIC RICE CREEK MANUFACTURING FACILITY TO MEDTRONIC PUERTO RICO OPERATION CNETERS (MPROC) IN VILLALBA AND JUNCOS.RANSFER OF INCOMING INSPECTION ACTIVITIES.
P110024|S001|ADVANCED CIRCULATORY SYSTEMS, INC.|1905 COUNTY ROAD C WEST||ROSEVILLE|MN|55113||Combination compression/decompression manual chest pump with impedance respiratory valve|RESQCPR SYSTEM|PIZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2015|06/15/2015|||APPR|APPROVAL FOR A MODIFICATION TO THE TIMING LIGHT SWITCH EXTENSION ON THE RESQPOD ITD 16.
P030017|S227|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPECTRA  SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2015|06/11/2015|||OK30|ADDITION OF A TRAY SEALING MACHINE.
P840064|S060|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2015|06/02/2015|||OK30|REPLACE THE CURRENTLY USED ASSAY AND IDENTIFICATION TECHNIQUES WITH AN ALTERNATE METHOD WHICH WILL IDENTIFY AND ASSAY SODIUM HYALURONATE IN YOUR PROVISC® AND DUOVISC® OPHTHALMIC VISCOSURGICAL DEVICES (OVD).
P890047|S046|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2015|06/02/2015|||OK30|REPLACE THE CURRENTLY USED ASSAY AND IDENTIFICATION TECHNIQUES WITH AN ALTERNATE METHOD WHICH WILL IDENTIFY AND ASSAY SODIUM HYALURONATE IN YOUR PROVISC® AND DUOVISC® OPHTHALMIC VISCOSURGICAL DEVICES (OVD).
P020025|S072|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2015|06/12/2015|||OK30|CHANGE IN THE DISTANCE OF MEASURE IN THE MINI ELECTRODE AND SEVERAL MINOR ADJUSTMENTS TO THE LASER MICROMETER.
P110010|S107|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/11/2015|||OK30|CHANGE EQUIPMENT TO OPTIMIZE INSPECTION OF THE PROXIMAL SUB-ASSEMBY FROM POINT-AND-CLICK SYSTEM TO DIGITAL VISION TECHNOLOGY.
P120005|S036|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|05/14/2015|07/02/2015|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE EXISTING FIRMWARE UPDATE TOOL TO ALLOW THE TOOL TO BE RUN ON MAC OS X OPERATING SYSTEMS, TO IMPROVE THE RUNTIME AND SIMPLIFY INSTALLATION STEPS ON CURRENTLY SUPPORTED WINDOWS PLATFORMS, TO ADD NOTIFICATIONS WHICHALERT USERS COMPATIBILITY ISSUES WITH USB 3.0 PORTS, AND TO IMPROVE COMPATIBILITY WITH FUTURE DEXCOM PRODUCTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 18 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G4 PLATINUM SYSTEM IS INDICATED FOR USEAS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G4 PLATINUM SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G4PLATINUM SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
P100023|S116|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/11/2015|||OK30|CHANGE EQUIPMENT TO OPTIMIZE INSPECTION OF THE PROXIMAL SUB-ASSEMBY FROM POINT-AND-CLICK SYSTEM TO DIGITAL VISION TECHNOLOGY.
P900056|S147|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/12/2015|||OK30|MANUFACTURING PROCESS CHANGE OF THE ROTALINK ADVANCER AND CATHETER MANUFACTURING LINES.
P030009|S081|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/12/2015|||OK30|ALTERNATIVE MANUFACTURING LINE FOR A COMPONENT OF THE MICROTRAC DELIVERY CATHETER.
P110013|S051|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/12/2015|||OK30|ALTERNATIVE MANUFACTURING LINE FOR A COMPONENT OF THE MICROTRAC DELIVERY CATHETER.
P030040|S009|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR AHBCM ASSAY|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/14/2015|03/11/2016|||APPR|Approval for the migration of the ADVIA Centaur® HBc IgM Assay (ADVIA Centaur® HBc IgM ReadyPack Reagents and ADVIA Centaur® HBc IgM Quality Control Materials) to the ADVIA Centaur® XPT system.
P020004|S116|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/11/2015|||OK30|IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS.
P040027|S044|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/11/2015|||OK30|IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS.
P040037|S080|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/11/2015|||OK30|IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS.
P130006|S019|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/11/2015|||OK30|IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS.
P040043|S074|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/11/2015|||OK30|IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS.
P050006|S047|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER, GORE CARDIOFORM SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/14/2015|06/11/2015|||OK30|IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS.
P010001|S012|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2015|06/11/2015|||OK30|ADDITION OF A GRINDING MACHINE.
P100026|S035|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2015|06/05/2015|||OK30|CHANGE NEUROPACE DEPTH LEAD DISTAL TIP ASSEMBLY PROCESS BY MODIFYING THE SLICONE PLUGGING PROCESS STEPS.
P840001|S302|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, & SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2015|06/11/2015|||OK30|UPDATE THE FINAL FUNCTIONAL TESTING SOFTWARE.
P960009|S228|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2015|06/11/2015|||OK30|UPDATE THE FINAL FUNCTIONAL TESTING SOFTWARE.
P060019|S032|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/15/2015|02/24/2016|||APPR|Approval for a manufacturing site located at Irvine Biomedical, Inc., in Irvine, California.
P990071|S031|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|SMARTABLATE SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2015|06/16/2015|||OK30|CHANGE TO THE ASSEMBLER OF THE PRINTED CIRCUIT BOARD MODULES (PCB MODULES) THAT ARE USED IN THE STOCKERT 70 RF GENERATOR.
P930039|S131|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, CAPSUREFIX NOVUS LEAD AND CAPSUREFIX NOVUS MRI SURESCAN LEAD, VITATRON CRYSTALLINE ACTIVE FIXATIO|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2015|06/06/2015|||OK30|UPDATES TO THE EQUIPMENT AND PROCESS FOR PLASMA-TREATED TUBING.
P960043|S090|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2015|10/09/2015|||APPR|APPROVAL FOR NEW MANUFACTURING SITES LOCATED AT ABBOTT VASCULAR, INC., IN TIPPERARY IRELAND, AND SYNERGY HEALTH IRELAND LTD., IN OFFALY IRELAND.
P080012|S028|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE IMPLANTABLE PUMP|LKK|HO|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/18/2015|07/31/2015|||APPR|APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
P120023|S001|ACUFOCUS, INC.|32 DISCOVERY|SUITE 200|IRVINE|CA|92618||Implant, corneal, refractive|KAMRA INLAY|LQE|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/18/2015|05/12/2016|||APPR|Approval of the post approval  study protocol.
P110010|S108|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2015|06/23/2015|||OK30|REMOVAL OF SEVERAL BALLOON CATHETER OUTER COMPONENT SAMPLE INSPECTIONS.
P100023|S117|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2015|06/23/2015|||OK30|REMOVAL OF SEVERAL BALLOON CATHETER OUTER COMPONENT SAMPLE INSPECTIONS.
P950037|S154|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2015|06/12/2015|||OK30|CHANGE TO THE SPRING BUSHINGS USED IN THE DEVICE HEADER AND THE ASSOCIATED MANUFACTURING EQUIPMENT.
P930039|S132|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2015|06/16/2015|||OK30|CHANGE THE SUPPLIER OF THE SLEEVE HEAD COMPONENT.
P960040|S346|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN EL ICD, ORIGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, INCEPTA ICD, ENERGEN I|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2015|06/04/2015|||OK30|ENHANCEMENT OF THE IS-1 AND IS-4 COIL SPRING INSPECTIONS AT THE SUPPLIER BY ADDING AN AUTOMATED VISION (AVI) SYSTEM.
P010012|S388|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2015|06/04/2015|||OK30|ENHANCEMENT OF THE IS-1 AND IS-4 COIL SPRING INSPECTIONS AT THE SUPPLIER BY ADDING AN AUTOMATED VISION (AVI) SYSTEM.
P130009|S035|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS EXPANDABLE INTRODUCER SHEATH SET|NPT|CV|30-Day Notice||N|05/18/2015|06/17/2015|||OK30|MODIFICATIONS TO THE SHEATH AND MARKER BAND MANUFACTURING PROCESS AND INSPECTIONS.
P970051|S131|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|COCHLEAR C1500 SERIES IMPLANTS|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2015|11/19/2015|||APPR|APPROVAL FOR THE MANUFACTURING SPECIFICATION TOLERANCES FOR THREE AREAS OF THE TOP SHELL (DEPTH, DOMING IN CENTER, AND FLATNESS OF CHASSIS MATING EDGE), A COMPONENT OF THE IMPLANT CASING.
P120016|S015|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM (VCS)|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/18/2015|07/08/2015|||APPR|APPROVAL FOR A CHANGE IN THE DEPLOYMENT FORCE PERFORMANCE SPECIFICATION FOR THE VASCADE 5F AND 6/7F DEVICE.
P070008|S065|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|EVIA HF, EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2015|06/12/2015|||OK30|CHANGE TO THE SPRING BUSHINGS USED IN THE DEVICE HEADER AND THE ASSOCIATED MANUFACTURING EQUIPMENT.
P050023|S091|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ILESTO 7 HF-T, ILESTO 5 HF-T, IFORIA 7 HF-T IFORIA 5 HF-T, INVENTRA 7 HF-T (DF-1), INVENTRA 7 HF-T (DF4), IPERIA 7HF-T (|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2015|06/12/2015|||OK30|CHANGE TO THE SPRING BUSHINGS USED IN THE DEVICE HEADER AND THE ASSOCIATED MANUFACTURING EQUIPMENT.
P910023|S357|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2015|07/13/2015|||APPR|APPROVAL FOR THE MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES.
P030054|S286|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2015|07/13/2015|||APPR|APPROVAL FOR THE MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES.
P040002|S054|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/2015|06/17/2015|||APPR|APPROVAL FOR UPDATES TO THE AFX INSTRUCTIONS FOR USE TO CLARIFY EXISTINGINFORMATION RELATED TO PROCEDURE PLANNING AND FOLLOW-UP IMAGING, AND TO IMPROVE THE INSTRUCTIONS FOR DELIVERY SYSTEM WITHDRAWAL OF THE AFX VELA PROXIMAL ENDOGRAFT.
P030035|S135|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2015|07/13/2015|||APPR|APPROVAL FOR THE MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES.
P880086|S257|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/19/2015|07/13/2015|||APPR|APPROVAL FOR THE MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES.
P900033|S047|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE|MDD|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/20/2015|08/06/2015|||APPR|APPROVAL FOR ADDING TWO NEW SIZE OFFERINGS: 4CM X 4CM AND 7CM X 7CM.
P130017|S002|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/20/2015|08/18/2015|||APPR|APPROVAL TO EXTEND THE SHELF LIFE OF THE COLOGUARD ASSAY REAGENTS(COLOGUARD MOLECULAR ASSAY REAGENTS, COLOGUARD MOLECULAR CONTROLS, COLOGUARD HEMOGLOBIN ASSAY REAGENTS, AND COLOGUARD HEMOGLOBIN CONTROLS), ON THE BASIS OF ADDITIONAL REAL-TIME STABILITY TESTING, FROM A SHELF-LIFE OF SIX (6) MONTHS TO A SHELF-LIFE OF NINE (9) MONTHS.
P100040|S021|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|05/20/2015|10/30/2015|||APPR|APPROVAL FOR AN UPDATE TO THE VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM¿S INSTRUCTIONS FOR USE (IFU) TO INCLUDE THE VALOR II POST APPROVAL STUDY DATA.
P940016|S017|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.)FUTURA APHERESIS SYSTEM|MMY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2015|06/15/2015|||OK30|PROPOSED REDUCTION OF CONTROLS PERFORMED AT THE END OF EACH BATCH.
P940016|S019|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM|MMY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/21/2015|06/18/2015|||OK30|IMPLEMENTATION OF AN ADDITIONAL DRYING STEP DURING THE PRODUCTION PROCESS.
P960009|S229|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS|MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE|NHL|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/21/2015|11/17/2015|||APPR|APPROVAL FOR A MODIFICATION TO THE INDICATION FOR USE (IFU) FOR THE MEDTRONIC DEEP BRAIN STIMULATION (BDS) THERAPY FOR PARKINSON¿S DISEASE AND CORRESPONDING LABELING CHANGES ASSOCIATED WITH THE IFU MODIFICATION. BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) USING MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS IN INDIVIDUALS WITH LEVODOPA-RESPONSIVE PARKINSON'S DISEASE OF AT LEAST 4 YEARS¿ DURATION THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.
P940016|S018|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|HEPARIN-INDUCED EXTRACORPOREAL LDL-PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM|MMY|GU|30-Day Notice||N|05/21/2015|06/16/2015|||OK30|REDUCTION IN TESTING AMOUNT FOR ALUMINUM DETERMINATION DURING IN-PROCESS CONTROLS.
P930014|S080|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ SINGLE-PIECE IOL WITH THE ACRYSERT C DELIVERY SYSTME|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/22/2015|07/20/2015|||APPR|APPROVAL FOR A COLOR CHANGE TO THE LENS-STOP AND PLUNGER COMPONENTS OF THE DELIVERY SYSTEM.
P140003|S001|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA 2.5 SYSTEM|OZD|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/22/2015|11/13/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860057|S137|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTH|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2015|06/18/2015|||OK30|ADD A PACKAGING LINE AND INCREASE THE MAXIMUM PERSONNEL CAPACITY OF THE CHANGI, SINGAPORE CLEAN ROOM #4 FROM 285 TO 402 PERSONNEL.
P130009|S036|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2015|06/18/2015|||OK30|ADD A PACKAGING LINE AND INCREASE THE MAXIMUM PERSONNEL CAPACITY OF THE CHANGI, SINGAPORE CLEAN ROOM #4 FROM 285 TO 402 PERSONNEL.
P980023|S067|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16, LINOX SMART TD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2015|06/12/2015|||OK30|USE OF ALTERNATE LASER EQUIPMENT FOR THE MANUFACTURE OF ICD LEADS.
P010015|S273|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2015|06/16/2015|||OK30|REDUCTION IN THE WELD MONITORING FREQUENCY FOR SELECTED WELDMANUFACTURING OPERATIONS FOR THE BATTERY USED IN THE DEVICES.
P090013|S187|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2015|06/16/2015|||OK30|REDUCTION IN THE WELD MONITORING FREQUENCY FOR SELECTED WELDMANUFACTURING OPERATIONS FOR THE BATTERY USED IN THE DEVICES.
P980035|S425|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG,AND ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/22/2015|06/16/2015|||OK30|REDUCTION IN THE WELD MONITORING FREQUENCY FOR SELECTED WELDMANUFACTURING OPERATIONS FOR THE BATTERY USED IN THE DEVICES.
P080030|S016|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|05/22/2015|07/21/2015|||APPR|APPROVAL OF CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.
P140002|S001|TERUMO MEDICAL CORPORATION|950 ELKTON BLVD||ELKTON|MD|21921||STENT, SUPERFICIAL FEMORAL ARTERY|MISAGO RX SELF-EXPANDING PERIPHERAL STENT|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2015|06/24/2015|||OK30|MODIFICATIONS TO THE DELIVERY SYSTEM, CHANGE TO TWO OF THE SUBCOMPONENTS OF THE DELIVERY CATHETER COMPONENT.
P080030|S017|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/26/2015|05/13/2016|||APPR|Approval for protocol modifications for the PAS2 study.
P970003|S179|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|PULSE GENERATOR-MODEL102, PULSE DUO GENERATOR-MODEL 102R|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/26/2015|08/21/2015|||APPR|APPROVAL FOR THE INTRODUCTION OF AN ALTERNATE MICROPROCESSOR, MANUFACTURED BY A DIFFERENT VENDOR, FOR THE MODEL 102/102R PULSE GENERATORS USED IN THE VNS THERAPY SYSTEM.
P100040|S022|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice||N|05/26/2015|06/25/2015|||OK30|MANUFACTURING THE VALIANT 17 APEX SINGLE TAA SUPPORT SPRING AT THE MEDTRONIC MEXICO EG MANUFACTURING SITE.
P830055|S159|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2015|06/25/2015|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP.
P950037|S155|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, EVIA DR, EVIA DR-T, EVIA SR,EVIA SR-T, ESTELLA DR, ESTELLA DR-T, EST|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2015|06/22/2015|||OK30|UPDATE THE BIOBURDEN TEST METHOD FOR ROUTINE MONITORING OF STERILIZED DEVICES.
P980023|S068|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16,LINOX SMART TD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2015|06/22/2015|||OK30|UPDATE THE BIOBURDEN TEST METHOD FOR ROUTINE MONITORING OF STERILIZED DEVICES.
P110013|S052|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2015|06/26/2015|||OK30|UPDATE TO THE VISUAL STANDARDS USED IN THE INSPECTION OF THE FINAL POUCH SEALING.
P050023|S092|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IPERIA 7 VR-T (DF-1),IPERIA 7 VR-T (DF-4),ITREVIA 7 VR-T (DF-1),ITREVIA 7 VR-T (DF-4),INVENTRA 7 VR-T (DF-1),INVENTRA 7|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2015|06/22/2015|||OK30|UPDATE THE BIOBURDEN TEST METHOD FOR ROUTINE MONITORING OF STERILIZED DEVICES.
P070008|S066|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ELUNA 8 HF-T,ETRINSA 8 HF-T, EPYRA 8 HF-T,EVIA HF-T,STRATOS LV,COROX OTW 75-BP,COROX OTW 85BP,COROX OTW-S 75-BP,COROX OT|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2015|06/22/2015|||OK30|UPDATE THE BIOBURDEN TEST METHOD FOR ROUTINE MONITORING OF STERILIZED DEVICES.
P050038|S024|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/ FLEXITIP XL-R|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2015|06/24/2015|||OK30|QUALIFICATION OF AN ADDITIONAL POUCH SEALER.
P130008|S008|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE UPPER AIRWAY STIMULATION THERAPY|MNQ|AN|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/27/2015|08/24/2015|||APPR|APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE MODEL 3024 IMPLANTABLE PULSE GENERATOR (IPG) TO 3 YEARS.
P840002|S013|CARDIOCOMMAND, INC.|4920 WEST CYPRESS STREET|SUITE 110|TAMPA|FL|33607|3837|SYSTEM, ESOPHAGEAL PACING|TAP SYSTEM 2A|LPA|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2015|03/24/2016|||APPR|Approval for a manufacturing site located at Cardiocommand, Inc., in Tampa, Florida, for the manufacture of the Tapsystem Model 2A device.
P010047|S039|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2015|06/26/2015|||OK30|ADD A SECOND SUPPLIER FOR THE BIOBURDEN TESTING, WHICH IS PERFORMED ON A QUARTERLY BASIS TO CONFIRM BIOBURDEN LEVELS PRIOR TO RELEASE OF THE EXTENDED APPLICATOR SPRAY TIPS FOR ETHYLENE OXIDE STERILIZATION REMAIN ACCEPTABLE.
P010012|S389|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA ICD'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2015|06/22/2015|||OK30|REMOVE A PROCESS MONITORING STEP DURING BATTERY ANODEMANUFACTURING FOR THE DEVICES.
P960040|S347|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CRT-D|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2015|06/22/2015|||OK30|REMOVE A PROCESS MONITORING STEP DURING BATTERY ANODEMANUFACTURING FOR THE DEVICES.
P840001|S303|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/2015|06/26/2015|||APPR|APPROVAL FOR CHANGES TO THE USER MANUAL FOR THE IMPLANTABLE NEUROSTIMULATOR RECHARGING SYSTEMS; SPECIFICALLY, THE ADDITION OF A WARNING STATEMENT FOR THE ANTENNA LOCATE FEATURE, AS WELL AS INSTRUCTIONS FOR EXITING THIS FEATURE, AND DIRECTIONS TO CONTACT MEDTRONIC IF THE PATIENT ENCOUNTERS ANY PROBLEMS.
P960009|S230|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|05/28/2015|06/26/2015|||APPR|APPROVAL FOR CHANGES TO THE USER MANUAL FOR THE IMPLANTABLE NEUROSTIMULATOR RECHARGING SYSTEMS; SPECIFICALLY, THE ADDITION OF A WARNING STATEMENT FOR THE ANTENNA LOCATE FEATURE, AS WELL AS INSTRUCTIONS FOR EXITING THIS FEATURE, AND DIRECTIONS TO CONTACT MEDTRONIC IF THE PATIENT ENCOUNTERS ANY PROBLEMS.
P920015|S155|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO MODEL 6946M LEAD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/28/2015|01/05/2016|||APPR|APPROVAL FOR THE SPRINT QUATTRO MODEL 6946M LEAD.
P860004|S228|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2015|06/26/2015|||OK30|RSW INTERFACE CONTROLLER SOFTWARE PROGRAM FOR USE DURING MANUFACTURING OF THE SYNCHROMED II PUMP (MODEL 8637).
P100023|S118|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2015|06/26/2015|||OK30|CHANGE TO THE INCOMING SPECIFICATION FOR AN INACTIVE INGREDIENT MANUFACTURING MATERIAL WHICH INCLUDES THE ELIMINATION OF REDUNDANT SOLVENT USE TESTING
P110010|S109|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/28/2015|06/26/2015|||OK30|CHANGE TO THE INCOMING SPECIFICATION FOR AN INACTIVE INGREDIENT MANUFACTURING MATERIAL WHICH INCLUDES THE ELIMINATION OF REDUNDANT SOLVENT USE TESTING
P010001|S013|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2015|06/19/2015|||OK30|ADDITION OF A GRINDING MACHINE.
P830063|S007|BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|GAMBRO PRISMAFLEX TPE 2000 SET|MDP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2015|06/26/2015|||OK30|CHANGE TO THE PYROGEN TEST METHOD (FROM RABBIT TEST TO KINETIC-CHROMOGENIC LAL TEST) USED FOR PRODUCT RELEASE OF PRISMAFLEX TPE 2000 SETS.
P120019|S007|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST V2|OWD|PA|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|05/28/2015|11/13/2015|15M-4344|11/30/2015|APPR|APPROVAL FOR THE COBAS® EGFR MUTATION TEST V2. THIS DEVICE IS INDICATED FOR:THE COBAS® EGFR MUTATION TEST V2 IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF DEFINED MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED TUMOR TISSUE (FFPET) FROM NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. THE TEST IS INTENDED TO AID IN IDENTIFYING PATIENTS WITH NSCLC WHOSE TUMORS HAVE DEFINED EGFR MUTATIONS AND FOR WHOM SAFETY AND EFFICACY OF A DRUG HAVE BEEN ESTABLISHED AS FOLLOWS: TARCEVA® (ERLOTINIB)/EXON 19 DELETIONS AND L858R AND TAGRISSO® (OSIMERTINIB) T790M.  DRUG SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING EGFR MUTATIONS ALSO DETECTED BY THE COBAS® EGFR MUTATION TEST V2: TARCEVA® (ERLOTINIB)/G719X, EXON 20 INSERTIONS, T790M, S768I AND L861Q/TAGRISSO® (OSIMERTINIB)/G719X, EXON 19 DELETIONS, L858R, EXON 20 INSERTIONS, S768I, AND L861Q.  FOR MANUAL SAMPLE PREPARATION, FFPET SPECIMENS ARE PROCESSED USING THE COBAS® DNA SAMPLE PREPARATION KIT AND THE COBAS Z 480 ANALYZER IS USED FOR AUTOMATED AMPLIFICATION AND DETECTION.
P860004|S229|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2015|06/26/2015|||OK30|ADDITION OF IN-PROCESS MONITORING FOR CATHETER TUBING INNER DIAMETER PLASMA TREATMENT.
P030017|S228|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355|||PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2015|06/26/2015|||OK30|ADDITION FOR ALTERNATE TEST EQUIPMENT SYSTEM USED FOR THE TESTING OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OF THE CHARGER.
P120010|S069|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/29/2015|06/24/2015|||OK30|ADDITION OF NEW EQUIPMENT FOR THE ENLITE SENSOR SUBSTRATE MANUFACTURING PROCESS. THE ENLITE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P010031|S502|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD, VIVA S/XT CRT-D'S||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|06/29/2015|||OK30|UPDATE TO THE HYBRID TRACKING DURING MANUFACTURING FOR THE DEVICES.
P980016|S539|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR/VR, EVERA XT DR/VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|06/29/2015|||OK30|UPDATE TO THE HYBRID TRACKING DURING MANUFACTURING FOR THE DEVICES.
P080032|S016|Boston Scientific Corp.|888 ROSS DRIVE|SUITE 100|SUNNYVALE|CA|94089||Bronchial thermoplasty system|ALAIR BRONCHIAL THERMOPLASTY SYSTEM|OOY|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2015|12/29/2015|||APPR|APPROVAL FOR DESIGN CHANGE TO THE ALAIR RF CONTROLLER TO REPLACE AN OBSOLETE COMPONENT THAT IS NO LONGER COMMERCIALLY AVAILABLE.
P980035|S426|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG AND ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|06/29/2015|||OK30|UPDATE TO THE HYBRID TRACKING DURING MANUFACTURING FOR THE DEVICES.
P010015|S274|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|06/29/2015|||OK30|UPDATE TO THE HYBRID TRACKING DURING MANUFACTURING FOR THE DEVICES.
P840001|S304|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATUION LEA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|07/01/2015|||OK30|CHANGES TO INCREASE SAMPLE SIZE FOR H2 PYCNOMETRY TEST.
P860004|S230|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED DRUG INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|07/01/2015|||OK30|CHANGES TO INCREASE SAMPLE SIZE FOR H2 PYCNOMETRY TEST.
P950037|S156|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2015|06/08/2016|||APPR|Approval for Siello S and Solia S pacing leads.
P930016|S045|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/01/2015|11/14/2016|||APPR|Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio Indication System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) for Use: in patients:1) with mixed astigmatism as measured by iDesign Advanced WaveScan Studio System where the magnitude of cylinder (1.0 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; 2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign Advanced WaveScan Studio System refraction as follows:- Spherical Equivalent: Magnitude of the difference is less than 0.625 D.- Cylinder: Magnitude of the difference is less than or equal to 0.5 D.; and 3) 18 years of age or older, and with refractive stability (a change of <=1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).
P830055|S160|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2015|08/21/2015|||OK30|REPLACEMENT OF VISUAL CHECKS WITH BARCODE SCANNERS AND A COMPUTER SOFTWARE PROGRAM.
P070026|S030|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2015|08/21/2015|||OK30|REPLACEMENT OF VISUAL CHECKS WITH BARCODE SCANNERS AND A COMPUTER SOFTWARE PROGRAM.
P080025|S094|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|07/01/2015|||OK30|CHANGES TO INCREASE SAMPLE SIZE FOR H2 PYCNOMETRY TEST.
P960009|S231|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|07/01/2015|||OK30|CHANGES TO INCREASE SAMPLE SIZE FOR H2 PYCNOMETRY TEST.
P970004|S199|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2015|07/01/2015|||OK30|CHANGES TO INCREASE SAMPLE SIZE FOR H2 PYCNOMETRY TEST.
P090016|S016|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/02/2015|08/06/2015|||APPR|APPROVAL FOR ADDITION OF NEEDLE ARTWORK AND INSTRUCTIONS FOR NEEDLE ATTACHMENT TO THE INSTRUCTIONS FOR USE IN THE PACKAGE INSERT.
P080006|S082|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2015|06/25/2015|||OK30|MINOR MODIFICATIONS TO MANUFACTURING PROCESS STEPS TO IMPROVE BONDING OF THE CONNECTOR SLEEVE AND LEAD BODY TUBING.
P130024|S005|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX 035 DRUG COATED BALLOON PTA CATHETER|ONU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/02/2015|11/20/2015|||APPR|APPROVAL FOR THE ADDITION OF THE 7 X 40 MM AND 7 X 60 MM DEVICE SIZES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUTONIX 035 DRUG COATED BALLOON PTA CATHETER AND IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AFTER PRE-DILATATION, OF DE NOVO OR RESTENOTIC LESIONS UP TO 150MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 4-7 MM.
P100047|S060|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2015|07/02/2015|||OK30|IMPLEMENTATION OF A FUNCTIONAL TESTER TO CONFIRM FUNCTIONALITY OF THECONNECTOR LOCKING MECHANISM FOR THE HEARTWARE® VENTRICULAR ASSIST DEVICE SYSTEM.
P100047|S061|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2015|07/09/2015|||OK30|IMPLEMENTATION OF A RE-QUALIFIED LASER WELDING STATION FOR THE WELDING OF COMPONENTS FOR THE HEARTWARE VENTRICULAR ASSIST SYSTEM.
P810031|S053|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2015|07/01/2015|||OK30|CHANGING FROM A MANUAL PACKAGING LINE TO AN AUTOMATED INSERTION PROCESS OF THE PRODUCT BLISTER AND/OR CANNULA FOR THE HEALON®, HEALON GV®, HEALON 5®, AND HEALON® ULTIMATE DUAL PACK.
P090029|S003|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE LP(TM) CERVICAL DISC|MJO|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/03/2015|07/07/2016|16M-2182|07/25/2016|APPR|Approval for the Prestige LP Cervical Disc. This device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays):  herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.  The PRESTIGE LP™ Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the PRESTIGE LP Cervical Disc.
P100047|S062|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2015|07/02/2015|||OK30|IMPLEMENTATION OF AN ADHESIVE DISPENSER DURING THE ASSEMBLY OF THE HEARTWARE VENTRICULAR ASSIST DEVICE HOUSING.
P900033|S048|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE|MDD|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2015|06/25/2015|||OK30|QUALIFICATION OF A NEW METHOD FOR QUARTERLY STERILIZATION DOSE AUDITS FOR THE INTEGRA DERMAL REGENERATION TEMPLATE MANUFACTURED AT THE PLAINSBORO, NEW JERSEY, INTEGRA MANUFACTURING FACILITY.
P980035|S427|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA SR MRI|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2015|06/27/2015|||OK30|FOUR (4) MANUFACTURING CHANGES FOR THE ADVISA SR MRI MODEL A3SR01 THAT HAD BEEN PREVIOUSLY APPROVED FOR PREDECESSOR DEVICES TO ALIGN THE ADVISA SR MRIMANUFACTURING PROCESS WITH THE PREDECESSOR DEVICE MANUFACTURING PROCESSES:1) IC SUPPLIER PROCESS FLOW UPDATE TO BICMOS;1) ADDITIONAL LEAK TEST STATION FOR MEDIUM RATE BATTERY; 2) ADDITIONAL WORK STATIONS AT MEDIUM RATE BATTERY SUPPLIER; AND3) FINAL PACK EQUIPMENT IMPLEMENTATION (COQUILPULS LINE) ¿ PHASE II.
P010030|S062|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2015|06/30/2015|||OK30|MAKE THE ¿MONITOR DETECT AND TREAT¿ TEST PERMANENT; AUTOMATE THE MONITOR DETECT AND TREAT TEST; REPLACE THE EXISTING AUTOTEST MONITOR PULSE TEST WITH THE AUTOMATED MONITOR DETECT AND TREAT TEST IN A SUBSEQUENT STEP OF THE PRODUCTION PROCESS.
P080012|S029|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE IMPLANTABLE PUMP|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|06/04/2015|09/01/2015|||APPR|APPROVAL FOR VERSION 1.02.1 OF THE PROMETRA TOUCHSCREEN PROGRAMMER SOFTWARE.
P020004|S117|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2015|07/02/2015|||OK30|SPLITTING THE CURRENT COMBINED CATHETER MANUFACTURING LINE INTO TWO SEPARATE LINES.
P000021|S027|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE|MTF|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2015|12/15/2015|||APPR|APPROVAL FOR THE MODIFIED PROCESS OF MANUFACTURING THEPOLYPROPYLENE RESIN USED IN THE PRODUCTION OF DIMENSION HM REACTION VESSELS AND THE VISTA LOCI REACTION VESSELS.
P020027|S022|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE|MTG|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/04/2015|12/15/2015|||APPR|APPROVAL FOR THE MODIFIED PROCESS OF MANUFACTURING THEPOLYPROPYLENE RESIN USED IN THE PRODUCTION OF DIMENSION HM REACTION VESSELS AND THE VISTA LOCI REACTION VESSELS.
P130017|S003|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|06/04/2015|08/19/2015|||APPR|APPROVAL FOR SEVERAL MINOR MODIFICATIONS TO THE TEST DEFINITIONSOFTWARE FOR COLOGUARD¿.
P090016|S017|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/05/2015|07/02/2015|||APPR|APPROVAL FOR CHANGES IN LABELING, UPDATES TO INCLUDE SAFETY INFORMATION RELATED TO SOFT TISSUE FILLERS.
P060011|S007|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7|||RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES||OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|10/15/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE TUMBLING PROCESS.
P980041|S033|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|07/08/2015|||OK30|MANUFACTURING CHANGES TO THE PRODUCTION AND PURIFICATION PROCESS OF ANTIBODY, WHICH IS USED IN PREPARATION OF THE PARAMAGNETIC PARTICLES FOR USE IN THE ACCESS AFP REAGENT.
P140003|S002|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA 2.5 SYSTEM|OZD|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|06/17/2015|||APPR|APPROVAL FOR THE IMPLEMENTATION OF ADDITIONAL QUALITY CONTROL MEASUREMENTS FOR FLUID TIGHTNESS OF THE IMPELLA PURGE CASSETTE.
P010012|S390|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||EASYTRAK 2 AND EASYTRAK  3 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD,ACUITY SPIRAL LEAD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|06/30/2015|||OK30|CHANGE TO THE INTERNAL INSPECTION REQUIREMENTS FOR MOISTURE CONTENT OF THE TWO PART MEDICAL ADHESIVE.
P050046|S025|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|06/30/2015|||OK30|CHANGE TO THE INTERNAL INSPECTION REQUIREMENTS FOR MOISTURE CONTENT OF THE TWO PART MEDICAL ADHESIVE.
P960004|S069|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROX ENDOCARDIAL PACING LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|06/30/2015|||OK30|CHANGE TO THE INTERNAL INSPECTION REQUIREMENTS FOR MOISTURE CONTENT OF THE TWO PART MEDICAL ADHESIVE.
P110002|S012|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/05/2015|06/30/2015|||APPR|APPROVAL FOR CLARIFICATIONS IN THE SURGICAL TECHNIQUE MANUAL.
P110009|S012|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/05/2015|06/30/2015|||APPR|APPROVAL FOR CLARIFICATIONS IN THE SURGICAL TECHNIQUE MANUAL.
N970012|S109|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700/AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|06/24/2015|||OK30|QUALIFICATION OF THE LASER FIXTURE METHOD AS A REPLACEMENT FOR THE CURRENT CALIPER METHOD USED FOR MEASURING A CRITICAL TUBE DIMENSION.
P000053|S060|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|06/24/2015|||OK30|QUALIFICATION OF THE LASER FIXTURE METHOD AS A REPLACEMENT FOR THE CURRENT CALIPER METHOD USED FOR MEASURING A CRITICAL TUBE DIMENSION.
P010020|S033|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Implanted fecal incontinence device|ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER|MIP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/05/2015|06/24/2015|||OK30|QUALIFICATION OF THE LASER FIXTURE METHOD AS A REPLACEMENT FOR THE CURRENT CALIPER METHOD USED FOR MEASURING A CRITICAL TUBE DIMENSION.
P140026|S001|SILK ROAD MEDICAL, INC|735 NORTH PASTORIA AVE||SUNNYVALE|CA|94085||STENT, CAROTID|ENROUTE TRANSCAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/05/2015|08/03/2015|||APPR|APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
P840001|S305|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTOREPRIME NEUROSTIMULATOR, PRIMEADVANCED NEUROSTIMULATOR, RESTOREADVANCED NEUROSTIMULATOR, PRIMEADVANCED SURESCAN MRI|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2015|07/08/2015|||OK30|PROCESS CHANGE FOR THE INSULATING MATERIAL.
P960009|S232|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA PC NEUROSTIMULATOR||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2015|07/08/2015|||OK30|PROCESS CHANGE FOR THE INSULATING MATERIAL.
P970003|S180|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|DEMIPULSE MODEL 103 GENERATOR AND ASPIRESR MODEL 106 GENERATOR|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2015|07/08/2015|||OK30|USE OF AN ALTERNATE ELECTRICAL TEST SYSTEM (ETS) KNOWN AS THE UNIVERSAL TEST SYSTEM (UTS) FOR THE MODEL 106 GENERATOR.
P920015|S156|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2015|07/07/2015|||OK30|UPDATES TO THE PULL TEST CONTROL LIMITS AND SAMPLING SIZE USED TO MONITOR A SPECIAL MANUFACTURING PROCESS.
P130030|S014|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2015|07/01/2015|||OK30|SOFTWARE AND HARDWARE UPDATED TO AN EXISTING MANUAL POLISHING LINE.
P110010|S111|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS ELUTING STENT SYSTEM, PROMUS PREMIER EVEROLIMUS ELUTING STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2015|07/01/2015|||OK30|SOFTWARE AND HARDWARE UPDATED TO AN EXISTING MANUAL POLISHING LINE.
P100023|S120|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2015|07/01/2015|||OK30|SOFTWARE AND HARDWARE UPDATED TO AN EXISTING MANUAL POLISHING LINE.
P050052|S067|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE (+) 1.5CC, RADIESSE (+) 0.8CC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2015|07/06/2015|||OK30|ELIMINATION OF BIOLOGICAL INDICATOR (BI) STERILITY MONITORING OF RADIESSE(+).
P020004|S118|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2015|07/09/2015|||OK30|ADDITION OF NEW EQUIPMENT FOR AUTOMATING THE STENT WINDING PROCESS
P100023|S121|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|06/09/2015|07/01/2015|||OK30|RELOCATION OF STENT CLEANING EQUIPMENT.
P110010|S112|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|06/09/2015|07/01/2015|||OK30|RELOCATION OF STENT CLEANING EQUIPMENT.
P130030|S015|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice||N|06/09/2015|07/01/2015|||OK30|RELOCATION OF STENT CLEANING EQUIPMENT.
P120010|S070|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/09/2015|02/18/2016|||APPR|Approval for replacing the Enlite Serter (MMT-7510) with the 1-Press Serter (MMT-7512), the blue charger (MMT-7705) in the current MiniLink Transmitter Kit (MMT-7725NA) with the grey charger (MMT-7715) and the use of one watertight tester instead of two in the MiniLink Transmitter Kit.
P950037|S157|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2015|07/07/2015|||OK30|ALIGNMENT OF TEST LIMITS FOR THE MOTION TESTS PERFORMED ON THE DEVICES.
P070008|S067|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|EVIA HF,EVIA HF-T, ENTOVIS HF,ENTOVIS HF-T|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2015|07/07/2015|||OK30|ALIGNMENT OF TEST LIMITS FOR THE MOTION TESTS PERFORMED ON THE DEVICES.
P100033|S004|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Prostrate cancer genes nucleic acid amplification test system|PROGENSA PCA3 ASSAY|OYM|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2015|11/12/2015|||APPR|APPROVAL FOR THE INTRODUCTION OF A NEW VIAL FILLER (THE CAPMATIC LINEAR BAMBINO FILLING SYSTEM) AT THE GCD1 MANUFACTURING FACILITY.
P920048|S011|HOLOGIC, INC.|1240 Elko Drive||Sunnyvale|CA|94089||ENZYME IMMUNOASSAY, FETAL FIBRONECTIN|RAPID FFN FOR THE TLIIQ SYSTEM|LKV|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|06/10/2015|02/05/2016|||APPR|Approval for design modifications to the cassette inner housing of your Rapid fFN test, to the pneumatic press plate used in the automated manufacturing process, and for introduction of a thickness gauge in the automated manufacturing process.
P990075|S033|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2015|07/01/2015|||OK30|CHANGES TO ADD A NEW CLEAN MANUFACTURING ENVIRONMENT (CME) ROOM FOR THE STORAGE OF DEVICE COMPONENT SHELLS. THE BREAST IMPLANTS ARE MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P030053|S029|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2015|07/01/2015|||OK30|CHANGES TO ADD A NEW CLEAN MANUFACTURING ENVIRONMENT (CME) ROOM FOR THE STORAGE OF DEVICE COMPONENT SHELLS. THE BREAST IMPLANTS ARE MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P060028|S012|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2015|07/01/2015|||OK30|CHANGES TO ADD A NEW CLEAN MANUFACTURING ENVIRONMENT (CME) ROOM FOR THE STORAGE OF DEVICE COMPONENT SHELLS. THE BREAST IMPLANTS ARE MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
P970004|S200|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|CHANGE TO THE INCOMING WAFER THICKNESS AND AN UPDATE TO THE TEST PROGRAM/SOLUTION FOR WAFER ACCEPTANCE TEST USED IN THE NEUROMODULATION SACRAL NERVE STIMULATION (SNS) THERAPY SYSTEMS.
P080025|S095|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|CHANGE TO THE INCOMING WAFER THICKNESS AND AN UPDATE TO THE TEST PROGRAM/SOLUTION FOR WAFER ACCEPTANCE TEST USED IN THE NEUROMODULATION SACRAL NERVE STIMULATION (SNS) THERAPY SYSTEMS.
P140010|S007|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER|ONU|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/10/2015|07/24/2015|||APPR|APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF THE FREEPAC COATING SOLUTION FROM 7 TO 14 DAYS.
P040004|S011|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
P100039|S003|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
P030049|S012|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAG ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
P110041|S002|SIEMENS CORP.|511 Benedict Avenue||Tarrytown|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAGII ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
P030040|S010|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC IGM ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
P090024|S002|SIEMENS HEALTHCARE DIAGNOSTICS|511 Benedict Avenue||Tarrytown|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBEAG ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
P090012|S011|STRATA SKIN SCIENCES, INC.|100 LAKESIDE DR STE 100||Horsham|PA|19044||Optical diagnostic device for melanoma detection|MELAFIND|OYD|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/11/2015|08/18/2016|||APPR|Approval for changing your calibration validation self-test method from the Field Phantom Imaging Self-Test to the Flap Shutter Self-Test.
P030056|S010|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ADVIA CENTAUR HCV ASSAY|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/11/2015|07/10/2015|||OK30|MANUFACTURE PROCESS CHANGE TO IMPLEMENT THE MLP COMMON PROCESS.
P810031|S054|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5|LZP|OP|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|06/11/2015|08/25/2015|||APPR|APPROVAL TO UPDATE THE LABELING FOR THE HEALON5® OPHTHALMIC VISCOSURGICALDEVICE (OVD) TO REMOVE THE PHYSICIAN TRAINING PROGRAM FOR NEW USERS AND TO REVISE THE PRECAUTIONS SECTION OF THE DIRECTIONS FOR USE TO ALLOW FOR OTHER OVD REMOVAL TECHNIQUES.
P100033|S005|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Prostrate cancer genes nucleic acid amplification test system|PROGENSA PCA3 ASSAY|OYM|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2015|07/09/2015|||OK30|EXTENSION OF THE PRE-CLEANING AND POST-CLEANING HOLD TIMES FOR AUTOMATED CLEANING OF STAINLESS STEEL TANKS USED IN THE MANUFACTURE OF THE SELECTION REAGENT FOR THE PROGENSA PCA3 ASSAY. IN ADDITION, A MANUAL CLEANING PROCESS OPTION IS ADDED FOR THE STAINLESS STEEL TANKS AS A BACKUP METHOD.
P100047|S063|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2015|07/08/2015|||OK30|RELOCATION OF SUPPLIER FOR AN HVAD SYSTEM COMPONENT.
P020025|S074|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER|OAD|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/12/2015|06/23/2015|||APPR|APPROVAL FOR CLARIFICATIONS TO THE ELECTRICAL CONNECTION SEQUENCE IN THE DIRECTIONS FOR USE (DFU).
P130027|S001|QIAGEN, INC.|QAIGEN STRASSE 1|40724|HILDEN||40724||Cytomegalovirus (cmv) dna quantitative assay|ARTUS CMV RGQ MDX KIT|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/12/2015|07/09/2015|||OK30|CHANGE TO THE SUPPLIER OF THE POSITIVE MATERIALS USED IN THE ARTUS CMV RGQ MDX KIT.
P110032|S011|LOMBARD MEDICAL TECHNOLOGIES INC|15420 LAGUNA CANYON ROAD|SUITE 260|IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AORFIX AN AAA FLEXIBLE STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/12/2015|09/01/2015|||APPR|APPROVAL FOR A CHANGE TO THE CENTER TUBE OF THE DELIVERY SYSTEM.
P990009|S041|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Agent, absorbable hemostatic, collagen based|FLOSEAL HEMOSTATIC MATRIX|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2015|07/16/2015|||OK30|CHANGE IN THE SYRINGE PLUNGER TIP MATERIAL FOR THE FLOSEAL HEMOSTATIC MATRIX (FLOSEAL).
P830055|S162|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2015|07/14/2015|||OK30|CHANGES TO TIBIAL INSERT ETCHING AND INSPECTION.
P980023|S069|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|PROTEGO SD 60/16, PROTEGO SD 65/16, PROTEGO SD 65/18, PROTEGO SD 75/18, PROTEGO TD 65/16, PROTEGO TD 65/18, PROTEGO TD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2015|07/07/2015|||OK30|ALTERNATE PLASMA EQUIPMENT TO BE USED IN PRODUCTION OF PROTEGO ICD LEADS.
P110040|S007|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE VASCULAR STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/15/2015|02/25/2016|||APPR|Approval for updating the labeling to include the post-approval study results.
P040037|S081|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/15/2015|10/14/2015|||APPR|APPROVAL FOR A POST-APPROVAL STUDY LABELING UPDATE REGARDING REVISIONS TO THE INSTRUCTIONS FOR USE TO INCLUDE THE FINAL STUDY RESULTS FOR THE RELINE EXTENDED FOLLOW-UP STUDY.
P130006|S020|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/15/2015|10/14/2015|||APPR|APPROVAL FOR A POST-APPROVAL STUDY LABELING UPDATE REGARDING REVISIONS TO THE INSTRUCTIONS FOR USE TO INCLUDE THE FINAL STUDY RESULTS FOR THE RELINE EXTENDED FOLLOW-UP STUDY.
P110029|S021|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE(LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54) ASSAYS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2015|07/13/2015|||OK30|CHANGE TO THE SUPPLIER OF BOVINE SERUM ALBUMIN (BSA) FOR USE INTHE MANUFACTURE OF PRECURSOR COMPONENTS FOR THE ARCHITECT HBSAG QUALITATIVE (LN 4P53),ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54), AND ARCHITECT AFP (LN 3P36) ASSAYS.
P120008|S008|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP ASSAY (LN 3P36)|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2015|07/13/2015|||OK30|CHANGE TO THE SUPPLIER OF BOVINE SERUM ALBUMIN (BSA) FOR USE INTHE MANUFACTURE OF PRECURSOR COMPONENTS FOR THE ARCHITECT HBSAG QUALITATIVE (LN 4P53),ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54), AND ARCHITECT AFP (LN 3P36) ASSAYS.
P900056|S149|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2015|07/09/2015|||OK30|MODIFICATION TO THE NON-DESTRUCTIVE PULL TEST METHOD.
P130029|S003|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|FLUENCY PLUS ENDOVASCULAR STENT GRAFT|PFV|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2015|07/15/2015|||APPR|APPROVAL TO IMPLEMENT AN ADDITIONAL QUALITY CONTROL INSPECTION STEP.
P050044|S032|STRYKER CORP.|2825 AIRVIEW BOULEVARD||PORTAGE|MI|49002||Agent, absorbable hemostatic, collagen based|VITAGEL RT3 SURGICAL HEMOSTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2015|07/16/2015|||OK30|MODIFICATIONS TO THE ON-GOING REAL TIME STABILITY STUDY WHICH IS USED FOR ESTABLISHING SHELF LIFE FOR VITAGEL RT3 SURGICAL HEMOSTAT.
P080009|S008|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/16/2015|07/16/2015|||APPR|APPROVAL FOR CHANGES TO THE CLINICAL USER GUIDE/ OPERATORS MANUAL TO PRECAUTION AGAINST THE USE OF QUATERNARY AMMONIUM COMPOUND (QAC)-BASED DISINFECTANTS.
P830055|S163|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2015|07/15/2015|||OK30|INTRODUCTION OF NEW CMM INSPECTION EQUIPMENT.
P840001|S306|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2015|07/16/2015|||OK30|CHANGES TO THE SOLDER DIPPING PROCESS.
P960009|S233|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2015|07/16/2015|||OK30|CHANGES TO THE SOLDER DIPPING PROCESS.
P080025|S096|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2015|07/16/2015|||OK30|CHANGES TO THE SOLDER DIPPING PROCESS.
P110010|S113|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2015|07/09/2015|||OK30|MODIFICATION TO THE INNER SHAFT MANUFACTURING PROCESS.
P080020|S015|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2015|07/16/2015|||OK30|IMPLEMENTATION OF A NEW LABORATORY INFORMATION MANAGEMENT SYSTEM TO ELECTRONICALLY CAPTURE AND MANAGE QUALITY CONTROL TEST DATA FOR THE MANUFACTURE OF GEL-ONE®.
P100026|S036|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/16/2015|09/02/2016|||APPR|Approval for an update to the Patient Data Management System (PDMS).
P980044|S026|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2015|07/16/2015|||OK30|IMPLEMENTATION OF A NEW LABORATORY INFORMATION MANAGEMENT SYSTEM TO ELECTRONICALLY CAPTURE AND MANAGE QUALITY CONTROL TEST DATA FOR THE MANUFACTURE OF SUPARTZ FX.
P980023|S070|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|PROTEGO DF-1 LEAD FAMILY|NVY|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|06/17/2015|10/29/2015|||APPR|APPROVAL FOR THE TRADE NAME CHANGE OF THE CURRENTLY MARKETED LINOXSMART LEAD FAMILY TO THE PROTEGO DF-1 LEAD FAMILY.
P140017|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MVS83|MOUNDS VIEW|MN|55112||Pulmonary valve prosthesis percutaneously delivered|MELODY TRANSCATHETER PULMONARY VALVE|NPV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2015|07/15/2015|||OK30|ADDITIONAL BOVINE TISSUE SUPPLIER.
P840001|S307|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2015|07/16/2015|||OK30|MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
P860004|S231|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2015|07/16/2015|||OK30|MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
P960009|S234|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2015|07/16/2015|||OK30|MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
P080025|S097|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2015|07/16/2015|||OK30|MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
P930014|S081|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES, ACRYSOF RESTOR INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|07/13/2015|||OK30|ALTERNATE SUPPLIER FOR POLYMERIZATION INITIATOR FOR ACRYSOF® INTRAOCULAR LENSES.
P030005|S124|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE, VALITUDE X4 CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|07/16/2015|||OK30|ADDITIONAL SUPPLIER FOR THE POWER CONDUCTOR COMPONENT.
N970003|S177|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|07/16/2015|||OK30|ADDITIONAL SUPPLIER FOR THE POWER CONDUCTOR COMPONENT.
P860004|S232|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|07/16/2015|||OK30|ADDITION OF A VISUAL INSPECTION FOR THE RL RESISTOR WHICH IS RELATED TO THE ALARM FUNCTION ON THE SYNCHROMED II PUMP.
P980037|S046|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY|MCX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|12/14/2015|||APPR|APPROVAL FOR AN ALTERNATE VENDOR
P090013|S188|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|07/17/2015|||OK30|ADDITION OF IN-PROCESS MONITORING FOR THE TUBING INNER DIAMETER PLASMA TREATMENT PROCESS.
P920015|S157|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|07/17/2015|||OK30|ADDITION OF IN-PROCESS MONITORING FOR THE TUBING INNER DIAMETER PLASMA TREATMENT PROCESS.
P930039|S133|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPESUREFIX LEAD, CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|07/17/2015|||OK30|ADDITION OF IN-PROCESS MONITORING FOR THE TUBING INNER DIAMETER PLASMA TREATMENT PROCESS.
P130023|S001|COHERA MEDICAL, INC|209 SANDUSKY STREET||PITTSBURG|PA|15212||Tissue adhesive for internal use|COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE|PJK|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/18/2015|07/17/2015|||APPR|ADDITION OF SPECIFICATIONS TO THE FOIL POUCH MOISTURE BARRIERPACKAGING.
P970004|S201|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|SNS URINARY NEUROSTIMULATORS IMPLANTABLE INTERSTIM|EZW|GU|30-Day Notice||N|06/16/2015|07/16/2015|||OK30|CHANGES TO THE SOLDER DIPPING PROCESS.
P970004|S202|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2015|07/16/2015|||OK30|MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
P980035|S428|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA, RELIA, IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2015|07/11/2015|||OK30|PROTEUS TEST APPLICATION UPDATE FOR THE DEVICES.
P840001|S308|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPECIFY SURESCAN MRI 5-6-5 LEAD 65 CM, SPECIFY SURESCAN MRI 5-6-5 LEAD 90 CM, SPECIFY SURESCAN MRI 2X8 LEAD 65 CM, SPECI|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/19/2015|02/05/2016|||APPR|Approval for the Specify SureScan MRI 5-6-5 and 2x8 surgical lead kits.
P030017|S229|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2015|09/18/2015|||APPR|APPROVAL FOR AN ALTERNATE QUALIFIED SUPPLIER (RESULTING IN A MINOR DESIGN CHANGE) FOR THE COIL CONNECTOR COMPONENT OF THE PRECISION SCS SYSTEM.
P100022|S014|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/18/2015|01/06/2016|||APPR|APPROVAL FOR CHANGES TO THE DELIVERY SYSTEM OF THE DEVICE.
P880047|S021|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2015|07/21/2015|||OK30|EXPAND THE EXISTING CLEAN MANUFACTURING ENVIRONMENT (CME) AREA IN YOUR SAN LORENZO MANUFACTURING FACILITY. IN ADDITION, THE 30-DAY NOTICE REQUESTED TO ADD A SECOND DEHUMIDIFICATION CHAMBER AS WELL AS ADD TWO ADDITIONAL FILLING BANKS (TO TOTAL FOUR FILLING STATIONS) INTO THIS NEW AREA.
P090013|S189|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2015|07/14/2015|||OK30|ALTERNATE SUPPLIER OF A SILICONE COMPONENT AND FOR INSPECTIONS OFTHAT COMPONENT TO BE PERFORMED BY THE SUPPLIER FOR LOT RELEASE.
P930039|S134|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACTIVE FIX|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/19/2015|07/14/2015|||OK30|ALTERNATE SUPPLIER OF A SILICONE COMPONENT AND FOR INSPECTIONS OFTHAT COMPONENT TO BE PERFORMED BY THE SUPPLIER FOR LOT RELEASE.
P140020|S001|MYRIAD GENETIC LABORATORIES|320 Wakara Way||Salt Lake City|UT|84108||Cancer-related germline gene mutation detection system|BRACANALYSIS CDX|PJG|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2015|04/29/2016|||APPR|Approval to add additional critical instruments of the same type using approved protocols.
P980023|S071|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|PROTEGO (S/SD/T/TD) ICD LEAD|NVY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/19/2015|07/17/2015|||APPR|APPROVAL FOR THE IS4/DF4-ADAPTER.
P040013|S021|Luitpold Pharmaceuticals, Inc.|800 Adams Avenue|Suite 100|Norristown|PA|19403||Biologic material, dental|GEM 21S GROWTH FACTOR ENHANCED MATRIX|NQA|DE|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/22/2015|08/21/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P020004|S119|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/22/2015|||OK30|IMPLEMENTATION OF PRODUCTION OF LARGER SIZES OF THE DEVICE ON ALL ULTRA THIN WALL (UTW) WRAPPER MACHINES.
P030005|S125|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE AND VALITUDE X4 CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/20/2015|||OK30|ADD AN ALTERNATE SUPPLIER OF THE TELEMETRY COIL USED IN THE DEVICES.
N970003|S178|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ALTURA 2, ESSENTIO, PROPONENT AND ACCOLADE|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/20/2015|||OK30|ADD AN ALTERNATE SUPPLIER OF THE TELEMETRY COIL USED IN THE DEVICES.
P910073|S130|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/16/2015|||OK30|ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.
P960006|S044|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Permanent defibrillator electrodes|FLEXTEND PACING LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/16/2015|||OK30|ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.
P010012|S391|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEAD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/16/2015|||OK30|ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.
P050046|S026|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY STEERABLE CORONARY SINUS PACING LEADS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/16/2015|||OK30|ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.
P960004|S070|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE 2 PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/16/2015|||OK30|ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.
P970003|S181|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|CYBERONICS VNS THERAPY SYSTEM|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/31/2015|||OK30|USE OF NEW PROCESSES FOR REPROCESSING TABLET COMPUTERS RETURNED FROM THE FIELD AND A PROCESS TO INSTALL PREVIOUSLY APPROVED SOFTWARE UPGRADES ON TABLET COMPUTERS THAT HAVE BEEN DISTRIBUTED TO THE FIELD FOR THE CYBERONICS® VNS THERAPY® SYSTEM TABLET COMPUTERS (MOTION MODEL CL900 OR CYBERONICS MODEL 700, MOTION MODEL CL910 OR CYBERONICS MODEL 720).
P130011|S001|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|SOLO SMART STENTLESS HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/22/2015|||OK30|MODIFICATION TO THE STERILIZATION PROCESS PARAMETERS, THE INCLUSION OF QUALITY CONTROL TESTS USED ON AN IN-PROCESS DEVICE, AND THE ADDITION OF BATCH TESTING TO THE FINAL STORAGE SOLUTION OF THE SOLO SMART HEART VALVE.
P140004|S001|VERTIFLEX (R), INCORPORATED|1351 Calle Avanzado Suite 100||San Clemente|CA|92673||Prosthesis, spinous process spacer/plate|SUPERION INTERSPINOUS SPACER|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/22/2015|11/18/2015|||APPR|APPROVAL OF POST-APPROVAL STUDY 1 FOR THE DEVICE.
P060037|S036|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-MOBILE AND LPS MOBILE BEARING KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2015|07/17/2015|||APPR|APPROVAL FOR INCREASED INSPECTION OF PMMA COATING THICKNESS.
P140004|S002|VERTIFLEX (R), INCORPORATED|1351 Calle Avanzado Suite 100||San Clemente|CA|92673||Prosthesis, spinous process spacer/plate|SUPERION INTERSPINOUS SPACER|NQO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/22/2015|12/15/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P100003|S006|GLOBUS MEDICAL INC.|2560 GENERAL ARMISTEAD AVE.||AUDUBON|PA|19403||PROSTHESIS, INTERVERTEBRAL DISC|SECURE -C CERVICAL ARTIFICIAL DISC|MJO|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2015|05/17/2016|||APPR|Approval for clarifying the worst-case temperature rise for the subject device and revising the labeling to adequately reflect those temperature. The Secure-C Cervical Artificial Disc can be now be labeled as MR Compatible.
P100049|S013|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2015|07/20/2015|||OK30|IMPLEMENTATION OF AN UPGRADED MEASUREMENT SYSTEM TO FACILITATE RECEIVING/INSPECTION AND VARIOUS R&D PROJECTS.
P020025|S075|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/23/2015|08/19/2015|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE PROXIMAL SHAFT OF YOUR INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER.
P970008|S064|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|MEQ|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/23/2015|08/28/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MANUFACTURING PROCEDURES OF THE PATIENT CABLE.
P890017|S017|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|CORDIS PALMAZ BALLOON-EXPANDABLE STENT|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/18/2016|||APPR|Approval for a change of the type of dosimeter used during routine sterilization dose auditing.
P090013|S190|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/20/2015|||OK30|NEW VENDOR FOR THE SOLDER PROCESS FOR HYBRID COMPONENTS; THE SOLDER PROCESS ITSELF IS ALSO BEING UPDATED TO REMOVE AND REPLACE EXPOSED TIN WITH STANDARD LEAD/TIN.
P890055|S060|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/23/2015|||OK30|CHANGE IN THE VENDOR SUPPLIER THAT SUPPLIES THE TUBING FOR THE MEDSTREAM REFILL KIT AND MEDSTREAM BOLUS KIT AND A CHANGE IN THE FACILITY FOR MANUFACTURING OPERATIONS WITHIN THE SAME CAMPUS FOR THE VENDOR SUPPLIER THAT SUPPLIES THE TYVEK PACKAGING LIDS FOR THE CODMAN 3000 PUMP AND THE TYVEK RULERS FOR THE CODMAN INTRASPINAL CATHETER KITS.
P050028|S047|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST, HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/23/2015|||OK30|REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
P110037|S022|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/23/2015|||OK30|REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
P100020|S015|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPC TEST,240 TESTS AND COBAS HPV TEST, 960 TESTS|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/23/2015|||OK30|REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
P110020|S014|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|ROCHE COBAS DNA SAMPLE PREPARATION KIT, ROCHE COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/23/2015|||OK30|REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
P120019|S008|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/23/2015|||OK30|REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
P140023|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/23/2015|||OK30|REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
P140003|S003|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA 2.5 SYSTEM|OZD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2015|07/08/2015|||OK30|IMPLEMENT A CHANGE TO THE MANUFACTURING PROCEDURE OF THE MOTOR STATOR ASSEMBLY.
P000014|S029|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/24/2015|12/16/2015|||APPR|APPROVAL FOR REMOVAL OF ANTIFOAM FROM A REAGENT AND IMPLEMENTATION OF A NEW WELL WASH PROTOCOL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS.
P910066|S027|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL1000, OL1000 SC, SPINALOGIC|LOF|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/24/2015|07/24/2015|||APPR|APPROVAL FOR THE LABELING TO BE IN CONFORMANCE WITH IEC 60601-1-6 ED. 3.1, IEC 60601-1-2: 2007, ANSI/AAMI ES 60601-1: 2005/A1:2012 AND IEC 60601-1-11: 2011.
P920015|S158|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TUNNELING TOOL|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/13/2015|||OK30|CHANGES TO THE STERILIZATION CYCLE PARAMETERS FOR THE DEVICES.
P100026|S037|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/23/2015|||OK30|CHANGE IN THE MATERIAL USED IN THE MANUFACTURING PROCESS OF THE TUNNELING TOOL STRAW BY REMOVING ONE OF THE MANUFACTURING PROCESS AIDS.
P100049|S014|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/24/2015|||OK30|IMPLEMENT AN UPGRADED, AUTOMATED WIRE LINK CUTTER.
P960016|S055|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/25/2015|08/31/2015|||APPR|APPROVAL OF A PROCESS AND DESIGN CHANGE FOR THE SHAFT OF THE LIVEWIRE TCABLATION CATHETER.
P000014|S030|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/23/2015|||OK30|CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.
P000044|S031|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/23/2015|||OK30|CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.
P010021|S026|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/23/2015|||OK30|CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.
P030024|S022|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/23/2015|||OK30|CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.
P100001|S007|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/23/2015|||OK30|CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.
P090028|S008|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG  REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/25/2015|07/23/2015|||OK30|CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.
N970003|S179|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2015|07/20/2015|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR LOW VOLTAGE CAPACITORS USED IN THE DEVICES.
P030005|S126|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2015|07/20/2015|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR LOW VOLTAGE CAPACITORS USED IN THE DEVICES.
P060037|S037|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2015|07/23/2015|||OK30|INTRODUCTION OF AN ADDITIONAL UPGRADE LINE, WATER GENERATION SYSTEM, AND CLEANROOM.
P040047|S041|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2015|07/23/2015|||OK30|IMPLEMENTATION OF AN IN-HOUSE INDUCTIVELY COUPLED PLASMA (ICP) WITH AN OPTICAL EMISSIONS SPECTROMETRY (OES) DETECTOR TO TEST RAW MATERIAL.
P050037|S060|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2015|07/24/2015|||OK30|IMPLEMENTATION OF AN IN-HOUSE INDUCTIVELYCOUPLED PLASMA (ICP) WITH AN OPTICAL EMISSIONS SPECTROMETRY (OES) DETECTOR TO TEST RAW MATERIAL.
P030017|S230|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/26/2015|09/22/2015|||APPR|APPROVAL FOR A NEW LEAD ANCHOR CONFIGURATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLIK X ANCHOR AND IS INDICATED FOR USE AS AN ANCHOR FOR SPINAL CORD STIMULATOR LEADS.
P050052|S068|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2015|07/24/2015|||OK30|IMPLEMENTATION OF AN IN-HOUSE INDUCTIVELYCOUPLED PLASMA (ICP) WITH AN OPTICAL EMISSIONS SPECTROMETRY (OES) DETECTOR TO TEST RAW MATERIAL.
P080010|S011|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/26/2015|07/24/2015|||OK30|EXTEND PRODUCTION LINE #1 TO MANUFACTURE 1-PIECE AND 3-PIECE ACRYLIC IOLS.
P910077|S150|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Pacemaker/icd/crt non-implanted components|LATITUDE INDUCTIVE COMMUNICATOR ; LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)|OSR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|07/20/2015|||OK30|REPLACE A WATER WASH SYSTEM FOR PRINTED CIRCUIT BOARD ASSEMBLIES.
P030011|S031|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|FREEDOM DRIVER SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|07/29/2015|||OK30|SUPPLIER MOVE TO A NEW FACILITY AND A CHANGE TO INCOMING ACCEPTANCE ACTIVITIES FOR THREE DEVICE COMPONENTS.
P920047|S083|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|02/08/2016|||APPR|approval for a manufacturing site located  in Heredia, Costa Rica.
P980003|S061|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|02/08/2016|||APPR|approval for a manufacturing site located  in Heredia, Costa Rica.
P020025|S076|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CHILLI II COOLED ABLATION SYSTEM|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|02/08/2016|||APPR|approval for a manufacturing site located  in Heredia, Costa Rica.
P930021|S015|THE STRAUMANN COMPANY|60 Minuteman Road||Andover|MA|01810||Biologic material, dental|STRAUMANN EMDOGAIN|NQA|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|07/29/2015|||OK30|QUALIFICATION OF AN ALTERNATIVE SUPPLIER FOR AMINO ACID ANALYIS.
P010030|S063|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/29/2015|11/06/2015|||APPR|APPROVAL FOR V07.5 MONITOR SOFTWARE WHICH INCLUDES NINE SOFTWARE CHANGES TO THE LIFEVEST WEARABLEDEFIBRILLATOR 4000 MONITOR, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FORSUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P060037|S038|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX/ LPS MOBILE BEARING KNEE SYSTEM|NJL|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|10/06/2015|||APPR|APPROVAL FOR AUTOMATING THE FINAL CLEANING PROCESS FOR NEXGEN LPS-FLEX/LPS MOBILE BEARING KNEE SYSTEM COMPONENTS, AND INTRODUCING A NEW CLEANING DETERGENT FOR TIBIAL COMPONENTS.
P110016|S018|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|FLEXABILITY ABLATION CATHETER (BI AND UNI DIRECTIONAL)|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|07/09/2015|||APPR|APPROVAL FOR A NEW IN-PROCESS INSPECTION STEP.
P130015|S003|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2015|07/28/2015|||OK30|ADDITION OF A WEAK POSITIVE CONTROL TO THE IN-PROCESS TESTING OF THE DEVICE.
P120016|S016|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/29/2015|07/29/2015|||APPR|APPROVAL FOR A LABELING CHANGE FOR THE IMPLEMENTATION OF AN ALTERNATIVE TECHNIQUE FOR RELEASE OF COLLAGEN FROM THE VASCADE DEVICE.
P040037|S082|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/30/2015|||OK30|USE OF A MODIFIED MOLD DESIGN FOR THE MANUFACTURE OF THE TRANSITION.
P130006|S021|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDR0PROSTHESIS WITH HEPARIN BIOACTIVE SURFAC, GORE VIABAHN ENDOPROTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/30/2015|||OK30|USE OF A MODIFIED MOLD DESIGN FOR THE MANUFACTURE OF THE TRANSITION.
P130026|S005|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2015|12/02/2015|||APPR|APPROVAL FOR A NEW DISTAL TIP ADHESIVE.
P040037|S083|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/30/2015|||OK30|USE OF A NEW POST BAKE CURING OVEN.
P130006|S022|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE, GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/30/2015|||OK30|USE OF A NEW POST BAKE CURING OVEN.
P980035|S429|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/20/2015|||OK30|HOLD TIME MODIFICATION PRIOR TO THE FINAL FUNCTIONAL TESTING.
P860047|S031|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||AID, SURGICAL, VISCOELASTIC|OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2015|09/25/2015|||APPR|APPROVAL TO CHANGE THE CANNULA ON THE 1 ML OCUCOAT 2% HYDROXYPROPYLMETHYLCELLULOSE OPHTHALMIC SURGICAL DEVICE TO A 25 GAUGE NEEDLE WITH A 32 DEGREE BEND.
P970003|S182|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|ASPIRESR GENERATOR -MODEL 106|MUZ|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2015|12/18/2015|||APPR|APPROVAL FOR USING A 2-POSITION PRE-SURGICAL SURFACE ELECTROCARDIOGRAPH (ECG) ASSESSMENT PROCEDURE TO IDENTIFY IMPLANT LOCATION.
P950029|S106|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR,REPLY DR,ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/31/2015|||OK30|ADDITIONAL REFLOW OVEN AND A MODIFICATION IN THE REFLOW OVEN QUALIFICATION METHOD.
P980049|S110|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101,ZL102))|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/31/2015|||OK30|ADDITIONAL REFLOW OVEN AND A MODIFICATION IN THE REFLOW OVEN QUALIFICATION METHOD.
P090013|S191|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/16/2015|||OK30|MOVE THE WIRE DRAWING PROCESS FOR THE PLATINUM IRIDIUM WIRE USED IN A HELIX COMPONENT FROM THE HERAEUS HANAU, GERMANY FACILITY TO THE HERAEUS SINGAPORE FACILITY.
P060027|S076|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PARADYM RF CRT-D 9750 (ZL102),INTENSIA CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/31/2015|||OK30|ADDITIONAL REFLOW OVEN AND A MODIFICATION IN THE REFLOW OVEN QUALIFICATION METHOD.
P930039|S135|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/16/2015|||OK30|MOVE THE WIRE DRAWING PROCESS FOR THE PLATINUM IRIDIUM WIRE USED IN A HELIX COMPONENT FROM THE HERAEUS HANAU, GERMANY FACILITY TO THE HERAEUS SINGAPORE FACILITY.
P940035|S011|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|ALERE NMP22 BLADDERCHEK TEST|NAH|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/28/2015|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE ALERE NMP22 BLADDERCHEK TEST, IN WHICH HEAT TREATED NORMAL MOUSE SERUM IS USED INSTEAD OF NORMAL MOUSE SERUM AS A CONTROL TEST LINE BLOCKING AGENT.
P130009|S037|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/01/2015|02/29/2016|16M-0926|03/15/2016|APPR|Approval for use in pediatric and adult patients with a dysfunctional, non-compliant Right Ventricular Outflow Tract (RVOT) conduit with a clinical indication for intervention and:  1) pulmonary regurgitation >=  moderate and/or; and 2) mean RVOT gradient >= 35 mmHg.
P010031|S504|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/20/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS FOR THE BATTERY ASSEMBLIES BY ADDING NEW EQUIPMENT TO THE BATTERY HEADER WELD FOR THE DEVICES.
P090013|S192|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/20/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS FOR THE BATTERY ASSEMBLIES BY ADDING NEW EQUIPMENT TO THE BATTERY HEADER WELD FOR THE DEVICES.
P980016|S540|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/20/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS FOR THE BATTERY ASSEMBLIES BY ADDING NEW EQUIPMENT TO THE BATTERY HEADER WELD FOR THE DEVICES.
P980035|S430|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2015|07/20/2015|||OK30|UPDATE TO THE MANUFACTURING PROCESS FOR THE BATTERY ASSEMBLIES BY ADDING NEW EQUIPMENT TO THE BATTERY HEADER WELD FOR THE DEVICES.
P030002|S035|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS)|MJP|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|03/24/2016|||APPR|Approval for a manufacturing site located at Bausch & Lomb, Incorporated, 21 Park Place Boulevard North, Clearwater, Florida 33759 as an alternate manufacturing facility for the Crystalens and Trulign IOLs.
P050052|S069|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/02/2015|11/23/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050052|S070|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/02/2015|09/02/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P050038|S025|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R|LMG|SU|30-Day Notice||N|07/02/2015|07/31/2015|||OK30|CHANGES IN THE DIMENSIONS OF THE ARISTA AH FLEXITIP XL-R COMPONENT¿S BACK CAVITY BASE INNER DIAMETER, HDPE INCOMING INNER TUBE INNER DIAMETER, AND HDPE TUBE COMPONENT LENGTH.
P980049|S111|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL 101) & (ZL102)|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|07/31/2015|||OK30|OPTIMIZE THE ELECTRICAL WELDING PROCESS FOR THE RF ANTENNA OF THE  DEVICES.
P060027|S077|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM RF CRT-D9750 (ZL101) & (ZL102) ; INTENSIA CRT-D 174|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|07/31/2015|||OK30|OPTIMIZE THE ELECTRICAL WELDING PROCESS FOR THE RF ANTENNA OF THE  DEVICES.
P110010|S114|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|07/30/2015|||OK30|UTILIZE POLYPROPYLENE TOTES AS CONTAINERS TO HOLD PRODUCTS DURING THE STERILIZATION PROCESS.
P130026|S006|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/20/2015|||APPR|APPROVAL TO MODIFY HOW THE PROXIMAL END OF THE PULLWIRE IS ATTACHED TO THE CATHETER¿S HANDLE.
P860003|S080|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PROCEDURAL KIT|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|07/30/2015|||OK30|CHANGE IN THE MANUFACTURING PROCESS OF THE EXTERIOR PRINTING OF THE LID STOCK FOR THE CELLEX® PROCEDURAL KITS.
P040044|S064|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|5F MYNXGRIP VASCULAR CLOSURE DEVICE (MX5021)|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|07/28/2015|||OK30|MODIFY THE HYDROGEL MANUFACTURING PROCESS.
P080011|S038|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|07/28/2015|||OK30|ADDITION OF A NEW AUTOCLAVE AT YOUR PUERTO RICO MANUFACTURING FACILITY.
P010030|S064|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|11/06/2015|||APPR|APPROVAL FOR TWO ELECTRICAL DESIGN CHANGES FOR THE LIFEVEST WEARABLEDEFIBRILLATOR 4000 MONITOR PULSE DELIVERY CIRCUITRY. THESE CHANGES INCLUDE AND INCREASE THE VALUES OF FOUR DC BLOCKING CAPACITORS ON THE DEFIBRILLATOR PCA AND TWO BULK CAPACITORS ON THE MONITOR COMPUTER/ANALOG (C/A) BOARD, AS WELL AS CHANGE THE DC BLOCKING CAPACITOR DIELECTRIC FROM Y5V TO X7R AND THE ADDITION OF FERRITE BEAD TO THE BATTERY POWER WIRE ON THE C/A BOARD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTSWHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
P890023|S023|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|07/28/2015|||OK30|ADDITION OF A NEW AUTOCLAVE AT YOUR PUERTO RICO MANUFACTURING FACILITY.
P780007|S054|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/02/2015|07/28/2015|||OK30|ADDITION OF A NEW AUTOCLAVE AT YOUR PUERTO RICO MANUFACTURING FACILITY.
P010032|S097|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|INFINITY NEUROSTIMULATION SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2015|09/19/2016|||APPR|Approval for the Clinician Programmer App (Version 3.1) Model 3874, Programmer App (Version 3.1) Model 3875, and the Infinity Neurostimulation System.
P140009|S001|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|INFINITY NEUROSTIMULATION SYSTEM|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/02/2015|09/19/2016|||APPR|Approval for the Clinician Programmer App (Version 3.1) Model 3874, Programmer App (Version 3.1) Model 3875, and the Infinity Neurostimulation System.
P890003|S333|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ELITE &II, MINUET,PREVA PREVA D PRODIGY SYNERGYST II,THERA &I, , VITATRON LEGACY, VITATRON LEGAACY,REVEAL|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P820003|S135|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P850051|S084|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST, PREMIER, PREVAIL,VITATRON LEGACY SR|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P900061|S136|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II PCD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P920015|S159|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|PCD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P930022|S019|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|LEGEND PLUS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P970012|S098|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|KAPPA 400|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P980016|S541|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST, GEMFAMILY, INTRINSCI, MARGUIS, MAXIMO FAMILY, ONYX, PROTECTA FAMILY,SECURA FAMILY,VITITUSO, EVERA FAMILY|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P980035|S431|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600,KAPPA 650,KAPPA 700,KAPPA 800,KAPPA 900, RELIA,SENSIA,SIGMA, VERSA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P980050|S101|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|JEWEL AF, GEM III AT|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P990001|S121|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|DIVA AND DEMA FAMILIES PULSE GNERATORS|NVZ|CV|Real-Time Process||N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P010015|S275|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, INSYNC, INSYNC III, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P010031|S505|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO, INSYNC, MACIMO, PROTECTA AND VIVA FAMILIES AND BRAVA CRTS-D'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P090013|S193|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI, ENRHYTHM MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/02/2015|08/17/2015|||APPR|APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
P130007|S005|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|Real-Time Process||N|07/06/2015|09/24/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE MATERIALS USED IN THE FLEXIBLE COPPER CIRCUIT FOR THE PRINTED CIRCUIT BOARD ASSEMBLY USED WITH THE ANIMAS VIBE INSULIN PUMP, A COMPONENT OF THE ANIMAS VIBE SYSTEM.
P130009|S038|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|ASCENDRA+ DELIVERY SYSTEM|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/10/2015|09/02/2015|||APPR|APPROVAL TO SUPPLY THE STOPCOCK UNATTACHED FROM THE ASCENDRA+ DELIVERY SYSTEM.
P070016|S010|WILLIAM COOK EUROPE APS|SANDET 6, DK-4632||BJAEVERSKOV||||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH TX2 TAA ENDOVASCULAR GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2015|08/03/2015|||OK30|CHANGE TO THE COATING PROCESS PARAMETERS FOR THE RELEASE-WIRES.
P050039|S017|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS)|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2015|04/26/2016|||APPR|Approval for a manufacturing site located at Orchid Detroit 23149 Commerce Drive, Farmington Hills, Michigan, 48335.
P040037|S084|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2015|08/04/2015|||OK30|IMPLEMENTATION OF A SUPPLIER PROCESS CHANGE TO THE TEMPERATURE SETTING OF THE CURING OVEN USED IN THE MANUFACTURING PROCESS OF A CATHETER COMPONENT.
P130006|S023|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2015|08/04/2015|||OK30|IMPLEMENTATION OF A SUPPLIER PROCESS CHANGE TO THE TEMPERATURE SETTING OF THE CURING OVEN USED IN THE MANUFACTURING PROCESS OF A CATHETER COMPONENT.
P000008|S034|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/06/2015|03/03/2016|||APPR|Approval of the following changes to the post-approval study for the device:  revisions reflecting alignment of protocol terminology with terms used in the electronic datamanagement system and points of clarification based on IRB input.
P040008|S012|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA ASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2015|08/05/2015|||OK30|ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR THE VIDAS STRIPS.
P920015|S160|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2015|07/31/2015|||OK30|AUTOMATED DOCUMENTATION PROCESS FOR FUNCTIONAL RESISTANCE TESTING EQUIPMENT.
P130021|S015|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|COREVALVE ENVOLUT R SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/06/2015|07/14/2015|||OK30|ULTRASONIC WASHING STEP FOR THE TIP GUIDE TUBE COMPONENT OF THE ENVEO R LOADING SYSTEM.
P110014|S006|DUNE MEDICAL DEVICES INC|111 SPEEN ST SUITE 101||FRAMINGHAM|MA|01701||Diagnostic low electric field|MARGINPROBE SYSTEM|OEE|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|07/06/2015|03/14/2016|||APPR|Approval for changes to the console in order to make the console compliant with the European Commission Restriction of the use of certain hazardous substances (RoHS) directive requirements.
P950029|S107|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2015|07/31/2015|||OK30|OPTIMIZATION OF CLEANING PROCESS AND SUBSEQUENT REMOVAL OF PRIMER BEFORE GLUING STEPS.
P060027|S078|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM RF CRT-D9750 (ZL102), INTENSIA CRT-D 174|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2015|07/31/2015|||OK30|OPTIMIZATION OF CLEANING PROCESS AND SUBSEQUENT REMOVAL OF PRIMER BEFORE GLUING STEPS.
P980049|S112|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2015|07/31/2015|||OK30|OPTIMIZATION OF CLEANING PROCESS AND SUBSEQUENT REMOVAL OF PRIMER BEFORE GLUING STEPS.
P130021|S016|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS|NPT|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/2015|11/10/2015|||APPR|APPROVAL FOR MODIFYING THE LABELING TO REMOVE THE PRECAUTIONS REGARDING PATIENTS WITH LOW FLOW/LOW GRADIENT AND END-STAGE RENAL DISEASE.
P030031|S069|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2015|08/06/2015|||OK30|ADDITIONAL SUPPLIER FOR THE CATHETER TIP ELECTRODE.
P040036|S051|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2015|08/06/2015|||OK30|ADDITIONAL SUPPLIER FOR THE CATHETER TIP ELECTRODE.
P960040|S350|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN, INOGEN, ORIGEN ICD DEVICES|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2015|07/31/2015|||OK30|MODIFY THE MINIMUM BURN-IN TIME FOR THE DEVICES.
P010012|S394|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||DYNAGEN, INOGEN, ORIGEN, CRT-D DEVICES||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2015|07/31/2015|||OK30|MODIFY THE MINIMUM BURN-IN TIME FOR THE DEVICES.
P980044|S027|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|VISCO-3|MOZ|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/2015|12/21/2015|||APPR|APPROVAL FOR VISCO-3. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
P980035|S432|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2015|07/31/2015|||OK30|CHANGES TO THE CASE-TO-COVER WELD PROGRAM FOR THE BATTERY USED IN THE DEVICES.
P040044|S065|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX ACE VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2015|08/03/2015|||OK30|ADDITION OF A SECONDARY CONTRACT STERILIZER.
P090013|S194|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/09/2015|07/31/2015|||OK30|CHANGES TO THE CASE-TO-COVER WELD PROGRAM FOR THE BATTERY USED IN THE DEVICES.
P120006|S021|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION ABDOMINAL STENT GRAFT SYSTEM, OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2015|08/07/2015|||OK30|CHANGE TO THE PYROGEN SAMPLING PLAN FOR FINISHED PRODUCT RELEASE OF ETHYLENE OXIDE (EO) STERILIZED PRODUCT IN THE OVATION STENT GRAFT/DELIVERY SYSTEM FAMILY.
P100021|S048|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-LLIAC(AUI) STENT GRAFT SYSTEM, ENDURA|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/10/2015|08/07/2015|||OK30|REPLACEMENT OF THE CURRENT V-BLOCK FIXTURE AT VENTION MEDICAL WITH A NEW DELRIN FIXTURE TO FACILITATE T-TUBE SUBASSEMBLY INSPECTIONS.
P050037|S061|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE DERMAL FILLER|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2015|08/05/2015|||APPR|APPROVAL FOR CHANGES IN PRODUCT LABELING.
P050052|S071|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, RADIESSE (+)|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2015|08/05/2015|||APPR|APPROVAL FOR CHANGES IN PRODUCT LABELING.
P960040|S351|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN EL. DYNAGEN MINI, INOGEN EL, INOGEN MINI,  ORIGEN EL, ORIGEN MINI ICD'S|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2015|09/17/2015|||APPR|APPROVAL FOR MODIFICATIONS TO PULSE GENERATOR FIRMWARE AND PROGRAMMER SOFTWARE, FOR LABELING CHANGES ASSOCIATED WITH THE SOFTWARE UPDATES, AND FOR THE COMBINATION OF PHYSICIAN TECHNICAL MANUALS AND DEVICE REFERENCE GUIDES INTO ONE COMPREHENSIVE DOCUMENT ACROSS DEVICE FAMILIES.
P010012|S395|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|COGNIS, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4, CRT-D|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2015|09/17/2015|||APPR|APPROVAL FOR MODIFICATIONS TO PULSE GENERATOR FIRMWARE AND PROGRAMMER SOFTWARE, FOR LABELING CHANGES ASSOCIATED WITH THE SOFTWARE UPDATES, AND FOR THE COMBINATION OF PHYSICIAN TECHNICAL MANUALS AND DEVICE REFERENCE GUIDES INTO ONE COMPREHENSIVE DOCUMENT ACROSS DEVICE FAMILIES.
P110041|S003|SIEMENS CORP.|511 Benedict Avenue||Tarrytown|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2015|10/26/2016|||APPR|Approval for the migration of the ADVIA Centaur® HBsAg II (HBsII), ADVIA Centaur® HBsAg Confirmatory and ADVIA Centaur® HBsAg Quality Control Material to the ADVIA Centaur® XPT system.
P960058|S116|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2015|11/24/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN VALENCIA, CALIFORNIA
P100039|S004|SIEMENS HEALTHCARE DIAGNOSTICS INC.|511 BENEDICT AVE.||TARRYTOWN|NY|10591||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR ANTI HBS2 ASSAY|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/13/2015|08/20/2016|||APPR|Approval for the migration of the ADVIA Centaur® Anti-HBs2 (aHBs2) Assay and ADVIA Centaur® Anti-HBs2 (aHBs2) Quality Control Material to the ADVIA Centaur® XPT system.
P130007|S006|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2015|08/10/2015|||OK30|CHANGE TO THE MOLDING PRESS EQUIPMENT FOR SEVERAL ANIMAS VIBE PUMP COMPONENTS. THE ANIMAS VIBE PUMP IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.
P010012|S396|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||INCEPTA, ENERGEN, PUNCTUA, DYNAGEN,INOGEN,ORIGEN CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2015|08/08/2015|||OK30|ADD AN ADDITIONAL INSPECTION STEP TO PULSE GENERATOR CASE HALF MANUFACTURING, ALONG WITH ASSOCIATED SPECIFICATION AND INSPECTION CRITERIA, THAT WILL ALLOW PULSE GENERATOR CASE HALF DISCONTINUITIES TO BE DISTINGUISHED FROM DENTS.
P130024|S006|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX 035 DRUG COATED BALLOON PTA CATHETER|ONU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/13/2015|01/29/2016|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGE IN STUDY DESIGN, PRIMARY EFFECTIVENESS COMPARATOR AND PRIMARY SAFETY COMPARATOR.
P960040|S352|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA, ENERGEN,PUNCTUA, DYNAGEN, INOGEN, ORIGEN ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2015|08/08/2015|||OK30|ADD AN ADDITIONAL INSPECTION STEP TO PULSE GENERATOR CASE HALF MANUFACTURING, ALONG WITH ASSOCIATED SPECIFICATION AND INSPECTION CRITERIA, THAT WILL ALLOW PULSE GENERATOR CASE HALF DISCONTINUITIES TO BE DISTINGUISHED FROM DENTS.
P040004|S012|SIEMENS HEALTHCARE DIAGNOSTICS|333 CONEY STREET||WALPOLE|MA|02032|1516|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ADVIA CENTAUR HBC TOTAL ASSAY|LOM|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2015|08/11/2016|||APPR|Approval for the migration of the ADVIA Centaur® HBc Total Assay (ADVIA Centaur® HBc Total ReadyPack Reagents and ADVIA Centaur® HBc Total Quality Control Materials) to the ADVIA Centaur® XPT system.
P920015|S161|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|HV SPLITTER/ADAPTOR KIT, SPRINT QUATTRO LEAD, SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2015|07/28/2015|||OK30|CHANGE TO THE LOCATION OF THE SUPPLIER OF THE LEAD INNER TRAY AND TO ADD VENTING CHANNELS TO THE INNER TRAY PACKAGE FOR THE DEVICES.
P960009|S235|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2015|08/13/2015|||OK30|IMPLEMENTATION OF A NEW AUTOMATED INSPECTION PROCEDURE FOR USE IN THE DBS LEAD DISTAL-END STRAIGHTNESS INSPECTION PROCEDURE; THE AUTOMATED INSPECTION SYSTEM IS INTENDED TO REPLACE THE MANUAL INSPECTION  PROCEDURE.
P980023|S072|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/16/2015|12/21/2015|||APPR|APPROVAL FOR THE PROMRI FULL BODY SCAN ICD SYSTEM.
P100022|S015|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2015|08/13/2015|||APPR|APPROVAL FOR THE ADDITION OF A TACTILE INSPECTION STEP DURING INCOMING QUALITY CONTROL.
P050017|S011|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2015|08/13/2015|||APPR|APPROVAL FOR THE ADDITION OF A TACTILE INSPECTION STEP DURING INCOMING QUALITY CONTROL.
P040033|S028|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/15/2015|08/10/2015|||APPR|APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING.
P120005|S037|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/16/2015|09/23/2015|||APPR|APPROVAL FOR THE FOLLOWING FIRMWARE MODIFICATIONS TO THE SHARE RECEIVER OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM: UPDATES TO PREVENT UNNECESSARY REBOOTS, IMPROVEMENTS OF SPEED OF USB TRANSFERS, PREVENTION OF LONG CHARGE TIMES, IMPROVEMENT OF CONNECTION RELIABILITY, IMPROVEMENT OF BATTERY LIFE, IMPROVEMENT OF BUTTON USABILITY, AND IMPROVEMENT OF UPGRADE PROCESS.
N970012|S110|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, impotence, mechanical/hydraulic|AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP)|FHW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/15/2015|08/04/2015|||APPR|APPROVAL FOR MODIFICATION OF THE INSTRUCTIONS FOR USE TO EXPAND THE ADVERSE DEVICE EFFECTS INFORMATION TO REFLECT NEWLY ACQUIRED INFORMATION.
P050042|S032|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV (LN 1L79)|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2015|08/13/2015|||OK30|REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
P050051|S030|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT AUSAB (LN 1L82)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2015|08/13/2015|||OK30|REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
P080023|S027|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE (LN 6L22)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2015|08/13/2015|||OK30|REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
P060035|S025|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2, DEPT. 09VB|ABBOTT PARK|IL|60064|3500|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT CORE-M (LN 6L23)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2015|08/13/2015|||OK30|REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
P110029|S022|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE (LN 4P53), ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54)|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2015|08/13/2015|||OK30|REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
P120008|S009|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ARCHITECT AFP (LN 3P36)|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2015|08/13/2015|||OK30|REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
P100025|S009|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)|OZA|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/16/2015|11/23/2015|||APPR|APPROVAL FOR (1) A NEW REGULATORY ANALYTICAL REFERENCE METHOD FOR ANALYSIS OF THE FINAL DRUG PRODUCT, PRANACTIN-CITRIC, THE DRUG COMPONENT OF THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT); AND (2) THE ADDITION OF AAIPHARMA SERVICES CORPORATION (AAIPHARMA) IN  WILMINGTON, NORTH CAROLINA (FEI NUMBER 1049418) AS A SECOND ANALYTICAL TESTING FACILITY FOR PRANACTIN-CITRIC.
P980007|S040|Abbott Laboratories|100 ABBOTT PARK RD.|AP5N-2 DEPT 09VB|ABBOTT PARK|IL|60064|6070|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ARCHITECT FREE PSA (LN 6C07)|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2015|08/13/2015|||OK30|REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
P910007|S049|Abbott Laboratories|100 ABBOTT PARK RD.||ABBOTT PARK|IL|60064|3500|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ARCHITECT TOTAL PSA (LN 6C06)|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/16/2015|08/13/2015|||OK30|REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
N970003|S181|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2|LWP|CV|30-Day Notice||N|07/17/2015|08/08/2015|||OK30|ADD AN AUTOMATED VISION INSPECTION SYSTEM FOR THE COIL SPRING INNER DIAMETER OF THE REFERENCED DEVICES AT THE SUPPLIER, BAL SEAL.
P030005|S128|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE CRT-P|NKE|CV|30-Day Notice||N|07/17/2015|08/08/2015|||OK30|ADD AN AUTOMATED VISION INSPECTION SYSTEM FOR THE COIL SPRING INNER DIAMETER OF THE REFERENCED DEVICES AT THE SUPPLIER, BAL SEAL.
P950005|S058|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS FLTR UNI -DIRECTIONAL CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2015|08/18/2015|||OK30|ACCEPTANCE OF A NEW PRODUCTION MACHINE FOR PERFORMING REFLOW OF THE QUAD LUMEN TIP.
P030031|S070|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2015|08/18/2015|||OK30|ACCEPTANCE OF A NEW PRODUCTION MACHINE FOR PERFORMING REFLOW OF THE QUAD LUMEN TIP.
P040036|S052|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2015|08/18/2015|||OK30|ACCEPTANCE OF A NEW PRODUCTION MACHINE FOR PERFORMING REFLOW OF THE QUAD LUMEN TIP.
P010068|S048|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS FLTR BI-DIRECTIONAL CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/17/2015|08/18/2015|||OK30|ACCEPTANCE OF A NEW PRODUCTION MACHINE FOR PERFORMING REFLOW OF THE QUAD LUMEN TIP.
P020050|S023|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM|LZS|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/20/2015|11/21/2016|||APPR|Approval for the WaveLight EX500 Excimer Laser System and Allegretto Wave Eye-Q Excimer Laser System.These devices are indicated for use in Photorefractive Keratectomy (PRK) treatments for:•  the reduction or elimination of up to -6.0 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -6.0 D of spherical component and up to -3.0 D of astigmatic component at the spectacle plane,•  patients who are 18 years of age or older and,•  patients with documentation of a stable manifest refraction defined as ?0.5 D preoperative spherical equivalent shift over one year prior to surgery.
P930039|S136|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/18/2015|||OK30|OUTSOURCE THREE COMPONENTS FROM MEDTRONIC ENERGY AND COMPONENT CENTER (MECC) TO AN ALTERNATE SUPPLIER FOR THE DEVICES.
P010015|S276|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P,SYNCRA CRT-P,VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/18/2015|||OK30|OUTSOURCE THREE COMPONENTS FROM MEDTRONIC ENERGY AND COMPONENT CENTER (MECC) TO AN ALTERNATE SUPPLIER FOR THE DEVICES.
P030036|S079|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/18/2015|||OK30|OUTSOURCE THREE COMPONENTS FROM MEDTRONIC ENERGY AND COMPONENT CENTER (MECC) TO AN ALTERNATE SUPPLIER FOR THE DEVICES.
P090013|S195|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/18/2015|||OK30|OUTSOURCE THREE COMPONENTS FROM MEDTRONIC ENERGY AND COMPONENT CENTER (MECC) TO AN ALTERNATE SUPPLIER FOR THE DEVICES.
P980035|S433|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG,ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/18/2015|||OK30|OUTSOURCE THREE COMPONENTS FROM MEDTRONIC ENERGY AND COMPONENT CENTER (MECC) TO AN ALTERNATE SUPPLIER FOR THE DEVICES.
P110013|S053|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/12/2015|||OK30|CHANGE IN THE CLEANING SOLVENT FOR UTENSILS USED DURING THE DRUG SPRAY PROCESS OF THE PRODUCT.
P110013|S054|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/19/2015|||OK30|MODIFICATIONS TO THE ANALYTICAL TEST METHODS THAT ARE PERFORMED AS PART OF THE QUALITY CONTROL ANALYTICAL BATCH RELEASE TESTING.
P980003|S062|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/19/2015|||OK30|ACCEPTANCE FOR A CHANGE OF EQUIPMENT USED DURING LEAK TESTING.
P120010|S071|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/20/2015|09/18/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P860004|S234|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2015|08/18/2015|||OK30|CHANGE FOR A RE-DESIGN TO THE MANUFACTURING FIXTURE USED TO PLACE THE HYBRID AND BATTERY IN THE SYNCHROMED II INFUSION PUMP.
P020004|S120|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/14/2015|||OK30|IMPLEMENT USE OF A NEW BURST TEST MACHINE.
P040027|S045|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/14/2015|||OK30|IMPLEMENT USE OF A NEW BURST TEST MACHINE.
P040037|S085|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/14/2015|||OK30|IMPLEMENT USE OF A NEW BURST TEST MACHINE.
P040043|S075|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/14/2015|||OK30|IMPLEMENT USE OF A NEW BURST TEST MACHINE.
P020045|S067|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|CRYOABLATION SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2015|09/28/2015|||APPR|APPROVAL FOR PRINTED CIRCUIT BOARD DESIGN AND ASSOCIATED LABELING CHANGES FOR THE AUTO CONNECTION BOX AND ECG CABLE.
P140010|S009|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL BALLOON CATHETER|ONU|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|12/04/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO, TIJUANA, BAJA CALIFORNIA, MEXICO.
P980016|S542|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, S VR ICD; EVERA XT DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/19/2015|||OK30|CHANGE FOR THE CONNECTOR MOLDING MANUFACTURING PROCESS FOR THE DEVICES.
P130007|S007|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/18/2015|||OK30|CHANGE TO THE CURRENT BASE ASSEMBLY PROCESS USED FOR THE MANUFACTURE OF THEPUMP BASE OF THE ANIMAS VIBE SYSTEM TO IMPROVE OVERALL MANUFACTURING PROCESS EFFICIENCY. THE PROPOSED CHANGES INCLUDE REMOVAL OF REDUNDANT TEST STEPS, SEPARATION OF COMPLEX ASSEMBLYOPERATIONS INTO SEVERAL DISCRETE STEPS, AND THE ADDITION OF AN IDENTICAL ASSEMBLY STATION.
P010031|S506|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D,PROTECTA XT CRT-D, VIV||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/19/2015|||OK30|CHANGE FOR THE CONNECTOR MOLDING MANUFACTURING PROCESS FOR THE DEVICES.
P060040|S043|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/20/2015|||OK30|QUALIFY AN ALTERNATE MANUFACTURING SITE FOR THE BEND RELIEF OF THE CANNULA.
P960004|S072|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/18/2015|||OK30|REMOVE CIRCULAR TOOLS FROM USE IN THE MANUFACTURING OF FINELINE II PACING LEADS.
P930014|S082|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|HIGH CYLINDER POWER ACRYSOF IQ TORIC IOLS|HQL|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/20/2015|09/18/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P910001|S078|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|CVX-300/CVX300-P EXCIMER LASER SYSTEM|LPC|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/22/2015|10/20/2015|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE ANTI-REFLECTIVE COATING THAT IS APPLIED TO THE LASER VESSEL WINDOWS.
P140020|S002|MYRIAD GENETIC LABORATORIES|320 Wakara Way||Salt Lake City|UT|84108||Cancer-related germline gene mutation detection system|BRACANALYSIS CDX|PJG|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/22/2015|07/26/2016|||APPR|Approval for 1) labeling changes to include results from additional non-clinical studies, and 2) a variant reclassification process.
P970051|S132|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|CP900 SERIES SOUND PROCESSORS|MCM|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2015|02/24/2016|||APPR|Approval for a manufacturing site located at Cochlear Ltd – Macquarie University, 1 University Avenue, Macquarie University, NSW 2066, Australia.
P840001|S309|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2015|08/20/2015|||OK30|CHANGES TO THE FINAL FUNCTIONAL TESTING (FFT) SOFTWARE OF THE IMPLANTABLE NEUROSTIMULATORS AT MEDTRONIC PUERTO RICO OPERATIONS IN JUNCOS, PUERTO RICO.
P960009|S236|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2015|08/20/2015|||OK30|CHANGES TO THE FINAL FUNCTIONAL TESTING (FFT) SOFTWARE OF THE IMPLANTABLE NEUROSTIMULATORS AT MEDTRONIC PUERTO RICO OPERATIONS IN JUNCOS, PUERTO RICO.
P100013|S012|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2015|08/20/2015|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A COMPONENT OF THE 5F, 6F AND 7F EXOSEAL VASCULAR CLOSURE DEVICES (VCDS).
P900056|S150|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2015|08/20/2015|||OK30|ADDING AN ALTERNATE COMPONENT MATERIAL SUPPLIER.
P930029|S052|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF MARINR CATHETERS, RF ENHANCER II CATHETERS, RF CONTRACTR CATHETERS AND RF CONDUCTR CATHETERS|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/23/2015|05/11/2016|||APPR|Approval for a manufacturing site located at Steris Isomedix, 2500 Commerce Drive, Libertyville, Illinois, as a contract sterilizer.
P910023|S358|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2015|09/16/2015|||APPR|APPROVAL FOR UPDATES TO THE MERLIN@HOME EX2000 V8.1.1 SOFTWARE FOR MODELS EX1150, EX1150W, EX1100, AND EX1100W TRANSMITTERS.
P030054|S287|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+H|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2015|09/16/2015|||APPR|APPROVAL FOR UPDATES TO THE MERLIN@HOME EX2000 V8.1.1 SOFTWARE FOR MODELS EX1150, EX1150W, EX1100, AND EX1100W TRANSMITTERS.
P030035|S136|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2015|09/16/2015|||APPR|APPROVAL FOR UPDATES TO THE MERLIN@HOME EX2000 V8.1.1 SOFTWARE FOR MODELS EX1150, EX1150W, EX1100, AND EX1100W TRANSMITTERS.
P880086|S258|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/23/2015|09/16/2015|||APPR|APPROVAL FOR UPDATES TO THE MERLIN@HOME EX2000 V8.1.1 SOFTWARE FOR MODELS EX1150, EX1150W, EX1100, AND EX1100W TRANSMITTERS.
P120024|S001|AESCULAP IMPLANT SYSTEMS, LLC|3773 Corporate Parkway||Center Valley|PA|18034||PROSTHESIS, INTERVERTEBRAL DISC|ACTIVL ARTIFICIAL DISC|MJO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/24/2015|10/21/2015|||APPR|APPROVAL FOR CHANGES TO THE ACTIVL INSTRUMENT TRAYS.
P020025|S077|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLANAV XP TEMPERATURE ABLATION CATHETER, INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER, INTELLANAV ABLATION CATHE|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/24/2015|02/24/2016|||APPR|Approval for design changes to incorporate a magnetic sensor into the IntellaTip XP and MiFi XP Temperature Ablation Catheters. The device, as modified, will be marketed under the trade name IntellaNav Xp Temperature Ablation Catheter and IntellaNav MiFi XP Temperature Ablation Catheter.
P980016|S543|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR,SVR, XT DR.XT VR ICD'S; MAXIMO II ICD, PROTECTA ICD & XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2015|08/20/2015|||OK30|MANUFACTURING PROCESS CHANGES FOR THE BATTERY USED IN THE DEVICES.
P010031|S507|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA CRT-D, VIVA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2015|08/20/2015|||OK30|MANUFACTURING PROCESS CHANGES FOR THE BATTERY USED IN THE DEVICES.
P120011|S001|IDEALIMPLANT|5005 LBJ FREEWAY SUITE 900||DALLAS,|TX|75244||Prosthesis, breast, inflatable, internal, saline|IDEAL IMPLANT SALINE FILLED BREAST IMPLANT|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2015|08/27/2015|||OK30|AN INCREASE IN THE SCALE AND CAPACITY OF SHELL PRODUCTION EQUIPMENT, AND THE ELIMINATION FOR THE NEED OF THE CONTRACT MANUFACTURER TO DILUTE THE SILICONE DISPERSION MATERIAL.
P100022|S016|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2015|10/26/2015|||APPR|APPROVAL FOR THE ADDITION OF A STENT RECLAIM PROCESS.
P070026|S031|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2015|05/04/2016|||APPR|Approval for a manufacturing site located at Orchid Orthopedics Solutions, 4600 East Shelby Drive, Suite 1, Memphis, Tennessee, 38118.
P130009|S039|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|ASCENDRA + DELIVERY SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2015|08/07/2015|||OK30|EXTEND THE APPLICATION AREA OF THE CURRENTLY APPROVED ADHESIVE AT THE Y-CONNECTOR TO GUIDEWIRE SHAFT BOND OF THE ASCENDRA+ DELIVERY SYSTEM AND ADD A QUALITY INSPECTION OF THE ADHESIVE AT BOTH THE Y-CONNECTOR TO GUIDEWIRE SHAFT AND Y-CONNECTOR TO BALLOON SHAFT BOND SITES.
P010013|S064|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/24/2015|10/22/2015|||APPR|
P010030|S065|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2015|08/22/2015|||OK30|ADDITION OF AN ALTERNATE SUPPLIER, CARCLO TECHNICAL PLASTICS (CTP) LATROBE, PA, FOR THE THERAPY ELECTRODE GEL BLISTER COVER.
P860057|S138|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS; THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX TI|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2015|08/07/2015|||OK30|EXTEND THE SHELF LIFE OF THE POLYTETRAFLUOROETHYLENE SEWING THREAD FROM 5 YEARS TO 10 YEARS.
P130009|S040|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2015|08/07/2015|||OK30|EXTEND THE SHELF LIFE OF THE POLYTETRAFLUOROETHYLENE SEWING THREAD FROM 5 YEARS TO 10 YEARS.
P140031|S001|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2015|08/07/2015|||OK30|EXTEND THE SHELF LIFE OF THE POLYTETRAFLUOROETHYLENE SEWING THREAD FROM 5 YEARS TO 10 YEARS.
P030022|S033|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|ANTHOLOGY FEMORAL STEMS|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2015|06/08/2016|||APPR|Approval for a manufacturing site located at Orchid Detroit 23149 Commerce Drive, Farmington Hills, MI 48335.
P930014|S083|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2015|08/26/2015|||OK30|CHANGE TO A NEW MEASUREMENT SYSTEM FOR QUALITY CONTROL INSPECTION OF OPTICAL PERFORMANCE OF YOUR ACRYSOF® MONOFOCAL IOLS (P930014) (MODELS SN60WF, SN6CWS, SA60WF, SA60AT, SN60AT, TYPE 7B, MA30AC, MN60AC, MA60AC, US60MP, MN60MA, AND MA60MA).
P030022|S032|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)|MRA|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/27/2015|09/25/2015|||APPR|APPROVAL FOR AN INNER LID PACKAGING CHANGE TO BIOLOX FORTE CERAMIC HEADS.
P030017|S231|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2015|08/25/2015|||OK30|MODIFICATION TO THE PLASMA CLEANING PARAMETERS USED DURING THE MANUFACTURING PROCESS.
P130006|S024|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2015|08/14/2015|||OK30|IMPLEMENT USE OF A NEW BURST TEST MACHINE.
P100047|S064|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/27/2015|01/15/2016|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:MODIFIED RANKIN SCORE (MRS) VALIDATION PLAN.
P100010|S050|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT ADVANCE ST|OAE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2015|07/31/2015|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP DURING FINAL INSPECTION OF THE DEVICE.
P130017|S004|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/27/2015|09/25/2015|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040002|S055|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|Real-Time Process||N|07/28/2015|10/07/2015|||APPR|APPROVAL FOR CHANGES TO THE AFX BIFURCATED DELIVERY SYSTEM.
P130021|S017|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|EN VEO R DELIVERY SYSTEM (DCS)COMPONENT OF CORE VALUE EVOLUT R SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2015|08/27/2015|||OK30|REDUCE THE SAMPLE SIZE USED FOR BACTERIAL ENDOTOXIN TESTING ON THE ENVEO R DELIVERY CATHETER SYSTEM COMPONENT OF THE MEDTRONIC COREVALVE EVOLUTE R SYSTEM.
P850007|S034|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|PHYSIO-STIM AND SPINAL-STIM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2015|08/26/2015|||OK30|IMPLEMENTATION OF AN ALTERNATE MACHINE TO PRODUCE TRANSDUCER COILS (CERVICAL-STIM ONLY) AND REMOVE REDUNDANT INSPECTION OF VARIOUS DEVICE COMPONENTS.
P030034|S008|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|CERVICAL-STIM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2015|08/26/2015|||OK30|IMPLEMENTATION OF AN ALTERNATE MACHINE TO PRODUCE TRANSDUCER COILS (CERVICAL-STIM ONLY) AND REMOVE REDUNDANT INSPECTION OF VARIOUS DEVICE COMPONENTS.
P100047|S065|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2015|08/27/2015|||OK30|MODIFICATIONS TO THE IN-PROCESS INSPECTIONS FOR THE SEWING RINGS.
P140018|S001|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||Agent, occluding, vascular, permanent|VENASEAL CLOSURE SYSTEM|PJQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/2015|10/07/2015|||APPR|APPROVAL FOR THE USE OF A SINGLE STERILE BARRIER PACKAGING SYSTEM FOR THE VENASEAL CLOSURE SYSTEM, IN PLACE OF THE DOUBLE STERILE BARRIER SYSTEM
P020050|S024|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Excimer laser system|ALLEGRETTO WAVE EYE-Q|LZS|OP|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/29/2015|10/15/2015|||APPR|APPROVAL FOR LABELING REVISIONS TO ADDRESS DESIGN CHANGE.
P970003|S183|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4)|MUZ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2015|10/28/2015|||APPR|APPROVAL FOR THE INTRODUCTION OF THE MOTION CL910 AND MINOR MODIFICATIONS AND ENHANCEMENTS TO THE VNS THERAPY PROGRAMMING SOFTWARE MODEL 250 VERSION 11.0.4.
P100017|S014|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2015|10/09/2015|||APPR|APPROVAL FOR TWO CHANGES TO THE APPLICATION SPECIFICATION FILES TO EXTEND THE CHILLER DELAY TIMER AND CHANGE THE CONDUCTIVITY SETTING FOR THE DETECTION OF RNA WASH2 LIQUID.
P080026|S016|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2015|10/09/2015|||APPR|APPROVAL FOR TWO CHANGES TO THE APPLICATION SPECIFICATION FILES TO EXTEND THE CHILLER DELAY TIMER AND CHANGE THE CONDUCTIVITY SETTING FOR THE DETECTION OF RNA WASH2 LIQUID.
P120012|S009|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II|OBF|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2015|10/09/2015|||APPR|APPROVAL FOR TWO CHANGES TO THE APPLICATION SPECIFICATION FILES TO EXTEND THE CHILLER DELAY TIMER AND CHANGE THE CONDUCTIVITY SETTING FOR THE DETECTION OF RNA WASH2 LIQUID.
P080020|S016|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2015|08/28/2015|||OK30|ADDITION OF A NEW CONDUCTIVITY METER AND AUTO-SAMPLER SYSTEM FOR MONITORING THE QUALITY OF WATER FOR INJECTION.
P970003|S184|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY MODEL 302 LEAD|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2015|08/28/2015|||OK30|REMOVAL OF AN ACETONE AND ISOPROPYL ALCOHOL PRE-CONDITIONING TREATMENT STEP IN THE MANUFACTURE OF YOUR MODEL 302 LEADS FOR THE VNS THERAPY SYSTEM.
P010012|S397|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, ORIGEN CRT-D, X4 CRT-D, INCEPTA TM ICD, ENERGEN TM ICD & PUNCTUA TM ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2015|08/21/2015|||OK30|ADDITION OF AN ALTERNATE SEMI-AUTOMATED 'THICKNESS AND LOADING' PROCESS STEP TO THE BATTERY MANUFACTURING LINE.
P960040|S353|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN EL ICD, MINI ICD, DYNAGEN EL ICD, MINI ICD, INOGEN EL ICD, MINI ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2015|08/21/2015|||OK30|ADDITION OF AN ALTERNATE SEMI-AUTOMATED 'THICKNESS AND LOADING' PROCESS STEP TO THE BATTERY MANUFACTURING LINE.
P110042|S049|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|GENE2.0 S-ICD: A209|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2015|08/21/2015|||OK30|ADDITION OF AN ALTERNATE SEMI-AUTOMATED 'THICKNESS AND LOADING' PROCESS STEP TO THE BATTERY MANUFACTURING LINE.
P010019|S040|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON B SOFT (HYDROPHILIC) CONTACT LENSE|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2015|08/28/2015|||OK30|CHANGE TO THE APHA COLOR SPECIFICATION.
P080020|S017|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/30/2015|08/28/2015|||OK30|IMPLEMENTATION OF A NEW CONTROL AND ALERT SYSTEM FOR MONITORING AND RECORDING THE CRITICAL SPEEDS DURING MANUFACTURING OF A COMPONENT OF GEL-ONE®.
P050006|S048|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE CARDIOFORM SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2015|09/01/2015|||OK30|REPLACE THE OVEN USED TO CREATE THE LEAFLET BAG COMPONENT OF THE GORE CARDIOFORM SEPTAL OCCLUDER.
P890003|S334|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK MONITOR 24950|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/31/2015|09/30/2015|||APPR|APPROVAL FOR MINOR DESIGN UPDATES TO THE EXISTING TELEMETRY M MODULE TO CREATE AN INSTRUMENT ONLY TELEMETRY M MODULE.
P970051|S133|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS CI532 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/31/2015|03/16/2016|||APPR|Approval for a new member of the CI500 series implant family in the Nucleus® Cochlear Implant System, the CI532 cochlear implant.
P100040|S023|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2015|08/20/2015|||OK30|RELOCATION OF A SUPPLIERS MANUFACTURING OPERATIONS.
P070027|S043|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/31/2015|08/20/2015|||OK30|RELOCATION OF A SUPPLIERS MANUFACTURING OPERATIONS.
P030011|S032|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL  HEART (TAH-T) SYSTEM|LOZ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/31/2015|11/27/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:  MODIFICATION TO THE APPROVED POST APPROVAL STUDY FOR THE COMPANION 2 DRIVER SYSTEM, WHICH USES THE INTERMACS REGISTRY AS THE DATA COLLECTION MECHANISM (INTERMACS COMPANION).
P030011|S033|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/03/2015|10/22/2015|||APPR|APPROVAL FOR A MATERIAL CHANGE TO THE DRIVELINE TUBING OF THE FREEDOM DRIVER SYSTEM.
P100021|S049|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II'S STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/11/2015|||OK30|INTRODUCTION OF A MANUFACTURING AID DURING THE DELIVERY SYSTEM EXTERNAL HANDLE ASSEMBLY PROCESS.
P950037|S158|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SETROX S 45, SETROX S 53, SETROX S 60, DEXTRUS 4135, DEXTRUS 4136, DEXTRUS 4137, SAFIO S 53, SAFIO S 60, TILDA JT45, TIL|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2015|08/31/2015|||OK30|ALTERNATE SUPPLIER FOR THE IRIDIUM COATING PROCESS ON THE LEADS.
P980023|S073|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Permanent defibrillator electrodes|LINOX SMART SD 60/16, LINOX SMART SD 65/16, LINOX SMART SD 65/18, LINOX SMART SD 75/18, LINOX SMART TD 65/16, LINOX SMAR|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2015|08/31/2015|||OK30|ALTERNATE SUPPLIER FOR THE IRIDIUM COATING PROCESS ON THE LEADS.
P960058|S117|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/03/2015|07/15/2016|||APPR|Approval Order should be issued for this PMA supplement.
P070008|S068|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW 75-BP, COROX OTW 85-BP, COROX OTW-S 75-BP, COROX OTW-S 85-BP, COROX OTW-L 85-BP, COROX OTW-L 75-BP, CELERITY 2|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2015|08/31/2015|||OK30|ALTERNATE SUPPLIER FOR THE IRIDIUM COATING PROCESS ON THE LEADS.
P110033|S018|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLBELLA XC|LMH|SU|Panel Track|Change Design/Components/Specifications/Material|N|08/03/2015|05/31/2016|16M-1401|06/02/2016|APPR|Approval for JUVÉDERM VOLBELLA® XC injectable gel.  The device is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.
P040029|S002|Euclid Systems Corporation|2776 Towerview Rd.||Herndon|VA|20171||Lens, contact, orthokeratology, overnight|JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR|NUU|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/03/2015|01/29/2016|||APPR|APPROVAL FOR UPDATED LABELING REFLECTING LONG-TERM DATA FROM THE POST-APPROVAL STUDY.
P030017|S232|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice||N|08/03/2015|09/02/2015|||OK30|USE OF A NEW INCUBATOR (BOEKEL MODEL 138225) IN THE CURING PROCESS FOR THE HEADER OF THE PRECISION SPECTRA IMPLANTED PULSE GENERATOR.
N16895|S097|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS|LPM|OP|30-Day Notice||N|08/03/2015|08/19/2015|||OK30|USE OF A MORE PURIFIED FORM OF THE RAW MATERIAL ANDIMPLEMENTATION FOR A TIGHTENED RAW MATERIAL PURITY SPECIFICATION.
P100040|S024|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2015|09/11/2015|||OK30|INTRODUCTION OF A MANUFACTURING AID DURING THE DELIVERY SYSTEM EXTERNAL HANDLE ASSEMBLY PROCESS AND AN ASSOCIATED MODIFICATION TO THE PACKAGING TRAY.
P860003|S081|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOSPHERESIS SYSTEM INSTRUMENT|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/04/2015|11/02/2015|||APPR|APPROVAL FOR THE REMOVAL OF THE ACCELEROMETER AND ASSOCIATED ACCELEROMETER ALARM FROM THE CELLEX® INSTRUMENT.
P010032|S098|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI)|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/04/2015|11/02/2015|||APPR|APPROVAL FOR 1) EXPANDED MRI CONDITIONS FOR MEDTRONIC DBS SYSTEMS; 2) UPDATES TO THE MODEL 37651 PATIENT RECHARGER SYSTEM;3) CLARIFICATIONS TO THE GUIDELINES FOR CONDUCTING CT SCANS ON DBS PATIENTS; 4) ADDITION OF SYMBOLS TO STERILE AND SHELF-BOX PACKAGE LABELS FOR SPECIFIED MODELS; AND (5) UPDATES TO PACKAGE CONFIGURATIONS FOR SPECIFIED MODELS.
P140009|S002|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO PATIENT PROGRAMMER|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/04/2015|11/02/2015|||APPR|APPROVAL FOR AN ALTERNATIVE RESIN MATERIAL (C1200HF) TO BE USED IN THE MANUFACTURE OF THE OUTER CASING OF THE GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTÉGÉ PROGRAMMER, PATIENT PROGRAMMER -MRI, AND BRIO PATIENT PROGRAMMER.
P060006|S069|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS  SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2015|09/02/2015|||OK30|MANUFACTURING CHANGE TO THE SEALING PROCESS OF POLY-POLY HEADER BAGS.
P130030|S016|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL MONORAIL AND OVER THE WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/04/2015|09/02/2015|||OK30|MANUFACTURING CHANGE TO THE SEALING PROCESS OF POLY-POLY HEADER BAGS.
P980035|S434|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2015|09/02/2015|||OK30|USE OF AN EXISTING ALTERNATE MANUFACTURING LINE TO MANUFACTURE THE DEVICES.
P030011|S034|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2015|11/02/2015|||APPR|APPROVAL FOR A FIRMWARE UPGRADE TO THE SINGLE BOARD COMPUTER OF THECOMPANION 2 DRIVER SYSTEM.
P130026|S008|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ ABLATION CATHETER|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/05/2015|09/03/2015|||APPR|APPROVAL TO UPDATE THE DESIGN AND INSPECTION LOCATION FOR THE SPINE COMPONENT OF THE TACTICATH ABLATION CATHETER.
P050017|S012|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2015|08/31/2015|||OK30|MODIFICATIONS TO THE MANUFACTURE OF THE HANDLE ASSEMBLY OF THE DELIVERY SYSTEM.
P930029|S053|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF CONTACTR, RF ENHANCR II, RF MARINR, RF CONDUCTR.|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2015|09/02/2015|||OK30|IMPLEMENTATION OF AN AUTOMATIC CUTTING MACHINE AND AN ASSOCIATED INSPECTION FIXTURE.
P110004|S012|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2015|09/03/2015|||OK30|CHANGE TO DECREASE THE CRIMPING AND PRE-CRIMPING FORCES IN THE 3.5X 24MM AND 4.0 X 08MM STENT SIZES.
P930014|S084|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRELOADED DELIVERY SYSTEM|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/07/2015|09/29/2015|||APPR|APPROVAL TO MODIFY THE ACRYSERT C DELIVERY SYSTEM BY REDUCING THE SIZE OF THE NOZZLE TIP, ADDING AN EXTERNAL NOZZLE TIP DEPTH GUARD, AND ADDING A PLUNGER SPRING AND PLUNGER LOCK, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ ASPHERIC INTRAOCULAR LENS WITH ULTRASERT PRELOADED DELIVERY SYSTEM. THE ACRYSOF IQ POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
P910071|S015|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2015|08/28/2015|||OK30|ADDITION OF A REINFORCING HEAD SEAM TO THE INNER POUCH OF THE DEVICE.
P120024|S002|AESCULAP IMPLANT SYSTEMS, LLC|3773 Corporate Parkway||Center Valley|PA|18034||PROSTHESIS, INTERVERTEBRAL DISC|ACTIVL ARTIFICIAL DISC|MJO|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/2015|11/04/2015|||APPR|APPROVAL FOR CHANGES TO THE ACTIVL® ARTIFICIAL DISC LABELING THAT PROPOSED CHANGES TO THE INSTRUCTIONS FOR USE, SURGICAL TECHNIQUE, PATIENT BROCHURE, AND PACKAGE LABEL TO REFLECT THE MR TESTING THAT WAS CONDUCTED.
P840001|S310|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2015|09/04/2015|||OK30|ACCEPT A NEW HARD STOP AND UPPER ARM IMPLEMENTATION FOR THE CRIMPERS USED DURING THE SLEEVE TO WIRE ASSEMBLY OF THE SPINAL CORD STIMULATION LEADS.
P130024|S007|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX 035 DRUG COATED BALLOON PTA CATHETER|ONU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/07/2015|09/04/2015|||APPR|APPROVAL FOR CLARIFICATION CHANGES TO THE IFU.
P040043|S076|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2015|09/04/2015|||OK30|IMPLEMENTATION OF AN OPTIC MEASURING AND LASER CUTTING MACHINE.
P130013|S003|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY|NGV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2015|09/03/2015|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P110010|S115|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/07/2015|09/03/2015|||OK30|CHANGE TO THE ENVIRONMENTAL MONITORING DATA COLLECTION PROCESS.
P010012|S398|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/2015|02/22/2016|||APPR|Approval for ACUITY X4 leads and accessories.
P910073|S132|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RELIANCE 4-SITE LEAD FAMILY|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/07/2015|02/22/2016|||APPR|Approval for ACUITYX4 leads and accessories.
P120010|S072|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSORS|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|01/21/2016|||APPR|APPROVAL OF AN ALTERNATE SUPPLIER OF GLUCOSE OXIDASE USED IN THE FABRICATION OF THE ENLITE GLUCOSE SENSOR THAT IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P030024|S023|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/08/2015|||OK30|CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
P910023|S359|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES; MERLIN.NET SYSTEM AND MERLIN@HOME|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/03/2015|||OK30|USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
P030054|S288|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DEVICES; MERLIN PROGRAMMER|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/03/2015|||OK30|USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
P880086|S259|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/03/2015|||OK30|USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
P030035|S137|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/03/2015|||OK30|USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
P990046|S041|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|02/08/2016|||APPR|Approval for modification to in-process inspection.
P970013|S065|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY PACEMAKER|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/03/2015|||OK30|USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
P950022|S088|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA, OPTISURE FAMILY OF HV LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/03/2015|||OK30|USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
P120020|S011|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|08/10/2015|01/22/2016|||APPR|APPROVAL FOR A POST-APPROVAL STUDY PROTOCOL.
P960030|S039|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ISOFLEX OPTIM FAMILY OF PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/03/2015|||OK30|USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
P960013|S077|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/03/2015|||OK30|USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
P850022|S025|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET SPINALPAK NON-INVASIVE SPINE  FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK  NON-INVASIVE BONE GROWTH STIMULATOR|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/09/2015|||OK30|QUALIFY TWO ALTERNATE SUPPLIERS FOR THE SOFT-TOUCH® HYDROGEL DISPOSABLE, CUTANEOUS ELECTRODES AND TO REINSTATE THE SOFT-TOUCH 63B HYDROGEL BASED, DISPOSABLE, CUTANEOUS ELECTRODE USED IN CONJUNCTION WITH THE BIOMET® ORTHOPAK® NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND SPINALPAK® NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM.
P050038|S026|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/09/2015|||OK30|CHANGES IN THE MANUFACTURING PROCESS OF THE ARISTA AH FLEXITIP XL-R STAINLESS STEEL COMPONENT.
P000039|S051|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|08/10/2015|01/08/2016|||APPR|APPROVAL FOR THE ADDITION OF INFORMATION FROM THE POST-APPROVAL STUDY TO THEINSTRUCTIONS FOR USE.
P120005|S038|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|11/06/2015|||APPR|APPROVAL FOR A CHANGE IN THE PACKAGING DESIGN FOR THE SENSOR/ APPLICATOR FOR THE G4 PLATINUM CGM SYSTEM AND THE MANUFACTURING LINE FOR THIS NEW PACKAGING.
P900060|S054|SORIN GROUP ITALIA S.R.L|VIA CRESCENTINO, SN||SALUGGIA, VC||13040||HEART-VALVE, MECHANICAL|CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|08/31/2015|||OK30|UPGRADE THE LEAFLET PROOF TESTER.
P040043|S077|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2015|09/10/2015|||OK30|USE OF AN ALTERNATE PTFE RESIN IN THE SEALING CUFF AND GRAFT COMPONENTS.
P030017|S233|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2015|09/10/2015|||OK30|ACCEPTANCE OF ALTERNATE LASER MARKING EQUIPMENT USED IN THE CASE HALF ETCHING PROCESS DURING THE MANUFACTURING OF THE PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR (IPG).
P980035|S435|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2015|09/09/2015|||OK30|NEW CONTINUOUS MONITORING SYSTEM FOR THE MANUFACTURING AREA AT A FINAL DEVICE MANUFACTURING FACILITY.
P010015|S277|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2015|09/09/2015|||OK30|NEW CONTINUOUS MONITORING SYSTEM FOR THE MANUFACTURING AREA AT A FINAL DEVICE MANUFACTURING FACILITY.
P010031|S509|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA  CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2015|09/09/2015|||OK30|NEW CONTINUOUS MONITORING SYSTEM FOR THE MANUFACTURING AREA AT A FINAL DEVICE MANUFACTURING FACILITY.
P090013|S196|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2015|09/09/2015|||OK30|NEW CONTINUOUS MONITORING SYSTEM FOR THE MANUFACTURING AREA AT A FINAL DEVICE MANUFACTURING FACILITY.
P980016|S546|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR .S VR, XT DR, XT VR ICD'S, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2015|09/09/2015|||OK30|NEW CONTINUOUS MONITORING SYSTEM FOR THE MANUFACTURING AREA AT A FINAL DEVICE MANUFACTURING FACILITY.
P010021|S027|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS ANTI-HCV ASSAY|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/08/2015|||OK30|CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
P000044|S032|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS HBSAG ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/08/2015|||OK30|CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
P030026|S030|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS ANTI-HBC IGM ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/08/2015|||OK30|CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
P000014|S031|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS ANTI-HBS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/08/2015|||OK30|CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
P100001|S008|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS ANTI-HBE ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/08/2015|||OK30|CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
P090028|S009|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS HBEAG ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2015|09/08/2015|||OK30|CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
P130013|S004|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE|NGV|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/12/2015|03/18/2016|||APPR|Approval of the post-approval study protocol.
P100042|S007|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/12/2015|11/24/2015|||APPR|APPROVAL FOR A CHANGE TO THE APTIMA HPV ASSAY SOFTWARE FROM VERSION 4.2.0 TO VERSION 4.2.1. THIS CHANGE IS BEING IMPLEMENTED TO REDUCE THE PROBE REAGENT MIXING SPEED IN THE HYBRIDIZATION PROTECTION ASSAY (HPA) INCUBATOR FROM 14 HZ TO 5 HZ ON THE TIGRIS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV ASSAY. THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, AND 68. THE APTIMA HPV ASSAY DOES NOT DISCRIMINATE BETWEEN THE 14 HIGH-RISK TYPES. CERVICAL SPECIMENS COLLECTED IN THINPREP PAP TEST VIALS CONTAINING PRESESRVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM.
P060037|S039|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2015|09/11/2015|||OK30|CHANGE IN THE PMMA PROCESS SPECIFICATION.
P140003|S004|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA VENTRICULAR SUPPORT SYSTEMS|OZD|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/12/2015|04/07/2016|16M-1915|07/05/2016|APPR|Approval for the Impella 2.5, Impella CP, Impella 5.0, and Impella LD catheters, in conjunction with the Automated Impella Controller, are temporary ventricular support devices intended for short term use (<= 4 days for the Impella 2.5 and Impella CP, and <=6 days for the Impella 5.0 and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.* The intent of the Impella System therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.*Optimal medical management and conventional measures include volume loading, use of pressors and inotropes support with or without IABP.
P010015|S278|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P. VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2015|09/10/2015|||OK30|UPDATES TO THE BATTERY H2 CATHODE MIX PROCESS.
P090013|S197|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2015|09/10/2015|||OK30|UPDATES TO THE BATTERY H2 CATHODE MIX PROCESS.
P980035|S436|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2015|09/10/2015|||OK30|UPDATES TO THE BATTERY H2 CATHODE MIX PROCESS.
P980018|S020|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEP TEST|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|09/10/2015|||OK30|ALTERNATE WAREHOUSE ESTABLISHED WITHIN THE CURRENT FACILITY. THE CHANGE IS BEING MADE FOR THE STORAGE OF FINISHED DEVICES AFTER THEY HAVE BEEN QA RELEASED.
P040005|S011|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 IQFISH PHARMDX|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|09/10/2015|||OK30|ALTERNATE WAREHOUSE ESTABLISHED WITHIN THE CURRENT FACILITY. THE CHANGE IS BEING MADE FOR THE STORAGE OF FINISHED DEVICES AFTER THEY HAVE BEEN QA RELEASED.
P100024|S007|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|09/10/2015|||OK30|ALTERNATE WAREHOUSE ESTABLISHED WITHIN THE CURRENT FACILITY. THE CHANGE IS BEING MADE FOR THE STORAGE OF FINISHED DEVICES AFTER THEY HAVE BEEN QA RELEASED.
P910023|S360|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|09/10/2015|||OK30|ALTERNATE SUPPLIER OF THE DF-1 CONNECTORS FOR THE DEVICES.
P030054|S289|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|09/10/2015|||OK30|ALTERNATE SUPPLIER OF THE DF-1 CONNECTORS FOR THE DEVICES.
P970004|S203|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|09/09/2015|||OK30|MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
P080025|S098|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM FOR BOWEL CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|09/09/2015|||OK30|MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
P140003|S005|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM|OZD|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/13/2015|04/07/2016|16M-1165|05/11/2016|APPR|Approval for the Impella 2.5, Impella CP, Impella 5.0, and Impella LD catheters, in conjunction with the Automated Impella Controller, are temporary ventricular support devices intended for short term use (<= 4 days for the Impella 2.5 and Impella CP, and <=6 days for Impella 5.0 and LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.* The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.*optimal medical management and conventional treatment measures include volume loading and use of pressors and inotropes, with or without IABP.
P060011|S008|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7|||RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES||OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|09/09/2015|||OK30|CHANGE IN THE BLISTER TRAY AND FOIL LID MATERIAL SPECIFICATION.
P100027|S022|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2015|09/11/2015|||OK30|ADDITION OF A NEW SUPPLIER OF A NOZZLE PLATE USED IN THE PRODUCTION OF THE BENCHMARK ULTRA INSTRUMENT, WHICH IS PART OF THE PMA SYSTEM FOR THE REAGENTS.
P990081|S032|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAYANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2015|09/11/2015|||OK30|ADDITION OF A NEW SUPPLIER OF A NOZZLE PLATE USED IN THE PRODUCTION OF THE BENCHMARK ULTRA INSTRUMENT, WHICH IS PART OF THE PMA SYSTEM FOR THE REAGENTS.
P030017|S234|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION,PRECISION SPECTRA, PRECISION NOVI  SPINAL CORD STIMULATOR (SCS) SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|08/14/2015|11/12/2015|||APPR|APPROVAL FOR A MINOR DESIGN CHANGE TO THE PLUG USED IN THE DISTAL TIP OF THE 1X16 INFINION LEADS TO MAKE THE TIP PLUG OF THE 1X16 INFINION LEAD SIMILAR TO THE TIP PLUG OF THE INFINION CX LEAD.
P010032|S099|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2015|09/10/2015|||OK30|ACCEPTANCE OF REPLACING AN EXISTING CENTERLESS GRINDER (GLEBAR TF-9DHD) WITH A NEW CENTERLESS GRINDER (GLEBAR GT-9DHD) USED DURING THE MANUFACTURING OF SCS LEADS, DBS LEADS, AND TERMINAL END SUBASSEMBLIES.
P140009|S003|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|SPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/14/2015|09/10/2015|||OK30|ACCEPTANCE OF REPLACING AN EXISTING CENTERLESS GRINDER (GLEBAR TF-9DHD) WITH A NEW CENTERLESS GRINDER (GLEBAR GT-9DHD) USED DURING THE MANUFACTURING OF SCS LEADS, DBS LEADS, AND TERMINAL END SUBASSEMBLIES.
P140004|S003|VERTIFLEX (R), INCORPORATED|1351 Calle Avanzado Suite 100||San Clemente|CA|92673||Prosthesis, spinous process spacer/plate|SUPERION INTERSPINOUS SPACER SYSTEM|NQO|OR|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/13/2015|12/11/2015|||APPR|APPROVAL FOR A CHANGE IN SUPPLIER OF THE FOLLOWING MANUAL INSTRUMENTS: P/N 100-9135, P/N 100-9146, P/N 100-9136, P/N 100-9137, P/N 100-9117, P/N 100-9127, AND P/N 100-9139.
P110013|S055|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2015|09/18/2015|||OK30|CHANGE TO THE CATHETER SUBASSEMBLY MANUFACTURING PROCESS.
P030009|S082|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2015|09/18/2015|||OK30|CHANGE TO THE CATHETER SUBASSEMBLY MANUFACTURING PROCESS.
P030054|S290|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUARTET FAMILY OF CRT LEADS|NIK|CV|Real-Time Process||N|08/17/2015|10/02/2015|||APPR|APPROVAL FOR 1458QL AND 1456Q QUADRIPOLAR LV LEADS.
P860004|S235|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2015|12/30/2015|||APPR|APPROVAL FOR CHANGES TO THE PROPELLANT TEST METHOD AND PROCESS CONTROL LIMITS USED DURING MANUFACTURING OF THE SYNCHROMED II PUMP.
P010013|S065|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/17/2015|10/15/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY TO REFLECT THE FDA APPROVAL OF THE USE OF TRANSVAGINAL ULTRASOUND (TVU) AS AN ALTERNATE CONFIRMATION TEST FOR ESSURE.
P990071|S032|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/17/2015|09/16/2015|||APPR|APPROVAL FOR AN UPDATED FOOT PEDAL WARNING.
P910023|S361|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/2015|02/12/2016|||APPR|Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.
P030054|S291|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/2015|02/12/2016|||APPR|Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.
P030035|S138|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/2015|02/12/2016|||APPR|Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.
P970013|S066|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/2015|02/12/2016|||APPR|Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.
P880086|S260|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/2015|02/12/2016|||APPR|Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.
P880006|S094|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/17/2015|02/12/2016|||APPR|Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.
P040024|S081|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE LYFT, RESTYLANE SILK|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2015|08/31/2015|||OK30|SITE CHANGE FOR THE STERILIZATION OF EMPTY HYPAK SYRINGES.
P110027|S009|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN KRAS RGQ PCR KIT|OWD|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2015|11/09/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN GMBH IN HILDEN, GERMANY.
P100029|S020|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2015|09/22/2015|||OK30|CHANGE TO TISSUE STITCHING SPECIFICATIONS.
P020025|S078|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EPT-1000XP CARDIAC ABLATION SYSTEM|OAD|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/18/2015|09/15/2015|||APPR|APPROVAL FOR LABELING MODIFICATIONS IN COMPLIANCE WITH ELECTRICAL AND EMC CONSENSUS STANDARDS.
P920047|S084|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/18/2015|09/15/2015|||APPR|APPROVAL FOR LABELING MODIFICATIONS IN COMPLIANCE WITH ELECTRICAL AND EMC CONSENSUS STANDARDS.
P980003|S063|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION SYSTEM|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/18/2015|09/15/2015|||APPR|APPROVAL FOR LABELING MODIFICATIONS IN COMPLIANCE WITH ELECTRICAL AND EMC CONSENSUS STANDARDS.
P140028|S001|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/19/2015|09/21/2015|||APPR|APPROVAL FOR THE POST APPROVAL STUDY PROTOCOL.
P140031|S002|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2015|03/16/2016|||APPR|Approval for a manufacturing site located at Edwards Lifesciences Pte., in Singapore, Singapore.
P980037|S047|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2015|09/17/2015|||OK30|CHANGE TO THE CONSOLE MANUFACTURING PROCESS.
P980037|S048|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|09/21/2015|||OK30|CHANGE TO THE COMPONENT CLEANING PROCESS.
P110016|S020|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|THERAPY COOL FLEX AND FLEXABILITY ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/20/2015|09/02/2015|||OK30|FINAL CLEANING SOLUTION CHANGE.
P130007|S008|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAL VIBE SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|08/20/2015|11/03/2015|||APPR|APPROVAL FOR REPLACING THE FLASH MEMORY OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) USED IN THE ANIMAS VIBE INSULIN PUMP, A COMPONENT OF THE ANIMAS VIBE SYSTEM, AS WELL AS SUBSEQUENT SOFTWARE CHANGES.
P130013|S005|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LAA CLOSURE TECHNOLOGY|NGV|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/21/2015|09/02/2015|||APPR|APPROVAL FOR CHANGES TO THE LABELING TO CLARIFY USE OF THE HEMOSTASIS VALVE ON THE WATCHMAN ACCESS SYSTEM.
P030005|S129|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE (MODEL U125), VALITUDE X4 (MODEL U128) CRT-PS|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/21/2015|11/03/2015|||APPR|APPROVAL FOR DESIGN CHANGES TO THE ACCELEROMETER COMPONENT AND ASSOCIATED CHANGES.
P110013|S056|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|09/17/2015|||OK30|CHANGES TO THE CONTROLLED ENVIRONMENT PROCESSING.
N970003|S182|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/21/2015|11/03/2015|||APPR|APPROVAL FOR DESIGN CHANGES TO THE ACCELEROMETER COMPONENT AND ASSOCIATED CHANGES.
P110035|S032|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|11/30/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC IRELAND LTD., IN GALWAY, IRELAND.
P960058|S118|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HIRESOLUTION BIONIC EAR SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|09/18/2015|||OK30|CHANGE IN LOCATION OF THE SUPPLIER OF RAW POLYETHYLENE MATERIALUSED TO MANUFACTURE BRAIDED FIBER THAT IS THEN USED IN THE HIRES 90KTM ADVANTAGE ANTENNA COIL, AND EXPANDED MATERIAL SPECIFICATIONS FOR BOTH THE RAW FIBER AND THE BRAIDED FIBER.
P100034|S014|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOCURE'S OPTUNE SYSTEM|NZK|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/21/2015|02/09/2016|||APPR|Approval of the following changes to the post-approval study for the device:  modification to enrollment criteria.
P960016|S056|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE CARDIAC ABLATION SYSTEM|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P040014|S026|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY CARDIAC ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P040042|S031|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P060019|S033|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P110016|S021|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|THERAPY COOL PATH DUO ABLATION, THERAPY COOL PATH SP ABLATION CATHETER,SAFIRE BLU DUO ABLATION CATHETER,SAFIRE BLU DUO S|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P100045|S006|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS|MOM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P010032|S100|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS EON,EONC,EON MINI,PROTEGE,PROTEGE MRI,AND PROCLAIM FAMILY SPINAL CORD STIMULATION (SCS) SYSTEMS|LGW|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113 for rework/relabeling of 12 class III devices.
P140009|S004|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO FAMILY DEEP BRAIN STIMULATION (DBS) SYSTEMS|MHY|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P840062|S052|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY|LPG|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2015|03/29/2016|||APPR|Approval for a change to the collagen processing equipment cleaning protocol.
P810006|S068|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTA ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2015|03/29/2016|||APPR|Approval for a change to the collagen processing equipment cleaning protocol.
P850010|S067|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2015|03/29/2016|||APPR|Approval for a change to the collagen processing equipment cleaning protocol.
P900033|S051|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA ARTIFICIAL  SKIN DERMAL REGENERATION TEMPLATE|MDD|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2015|03/29/2016|||APPR|Approval for a change to the collagen processing equipment cleaning protocol.
P000039|S052|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER,CRIBRIFORM OCLUDER,AND DELIVERY AND EXCHANGE SYSTEMS|MAE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P020024|S041|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS|MAE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota,  55113,  for rework/relabeling of 12 class III devices.
P020004|S121|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2015|09/21/2015|||OK30|OPTIONAL USE OF AN ALTERNATE METHOD TO LOOSEN THE GRAFT FROM THE PROCESSING MANDREL.
P020004|S122|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2015|09/23/2015|||OK30|RELOCATION OF THE PROCESSES AND EQUIPMENT FOR THE EXCLUDER SIM-PULL SYSTEM CATHETER MANUFACTURING LINE FROM FLAGSTAFF, AZ TO PHOENIX, AZ.
P930038|S077|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL STS+,ANGIO-SEAL VIP, AND ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICES|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P040040|S024|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/21/2015|04/29/2016|||APPR|Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.
P010003|S019|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/27/2015|09/24/2015|||OK30|CHANGE IN THE METHOD TO DETERMINE PROTEIN CONCENTRATION.
P130026|S009|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/27/2015|11/19/2015|||APPR|APPROVAL FOR CHANGES TO THE OPTICAL SENSOR ANALYZERS IN THE TACTICATH QUARTZ EQUIPMENT.
P990081|S033|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2015|09/24/2015|||OK30|CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS.
P100027|S023|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2015|09/24/2015|||OK30|CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS.
P020055|S017|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)|NKF|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2015|09/24/2015|||OK30|CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS.
P140025|S001|VENTANA MEDICAL SYSTEMS, INC.|1910 EAST INNOVATION PARK DR.||TUCSON|AZ|85755||Immunohistochemistry assay, antibody, anaplastic lymphoma kinase|VENTANA ALK (D5F3) CDX ASSAY|PKW|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2015|09/24/2015|||OK30|CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS.
P030053|S030|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2015|09/24/2015|||OK30|CHANGE THE SAMPLE SIZE FOR IN-PROCESS SILICONE GEL PENETRATION TESTING CONDUCTED AT THE MENTOR IRVING, TEXAS MANUFACTURING FACILITY.
P140012|S001|RESHAPE MEDICAL, INC.|100 CALLE IGLESIA||SAN CLEMENTE|CA|92672||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|RESHAPE INTEGRATED DUAL BALLOON SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/26/2015|01/14/2016|||APPR|APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
P040024|S082|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE LYFT, RESTYLANE SILK|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/28/2015|09/24/2015|||APPR|APPROVAL FOR CHANGES IN PRODUCT LABELING THAT INCLUDED NEW SAFETY INFORMATION.
P910001|S079|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/28/2015|08/31/2016|||APPR|Approval for a substitution of the SpectraGlide hydrophilic coating for the TreeFrog hydrophilic coating on the ELCA catheters.
P890003|S336|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK PATIENT MONITOR 2490G, CARDIOSIGHT READER, CARELINK EXPRESS, REVEAL DX/XT, REVEAL LINQ INSERTABLE CARDIAC MONIT|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2015|10/07/2015|||APPR|APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.
P980016|S547|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II. INSYNC MARQUIS, PROTECTA/ PROTECTA XT DR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2015|10/07/2015|||APPR|APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.
P980035|S437|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA, ENRHYTHM MRI|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2015|10/07/2015|||APPR|APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.
P010015|S279|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2015|10/07/2015|||APPR|APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.
P010031|S510|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|MAXIMO II CRT-D, CONCERTO, CONCERTO II, CONSULTA, INSYNC II MARQUIS, INSYNC III MARQUIS, INSYNC MAXIMO, INSYNC SENTRY,|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2015|10/07/2015|||APPR|APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.
P090013|S198|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/28/2015|10/07/2015|||APPR|APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.
P990040|S021|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM.|KGG|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2015|09/25/2015|||OK30|REMOVAL OF THE INCOMING INSPECTION REQUIREMENT FOR PERFORMING MATERIAL IDENTIFICATION VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING ON THE N-BCA SELF-PIERCING CAPS.  REDUCE THE SAMPLING REQUIREMENT FOR THE VISUAL APPEARANCE INSPECTION OF THE N-BCA.
P100042|S008|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2015|09/19/2016|||APPR|Approval of a new supplier for a critical raw material.
P120007|S006|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV 16 18/45 GENOTYPE ASSAY|OYB|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/28/2015|09/19/2016|||APPR|Approval for a change of a raw material supplier.
P100023|S122|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (OTW AND MR)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|09/29/2015|||OK30|CHANGE TO SECONDARY PACKAGING PROCESS.
P980035|S438|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|09/29/2015|||OK30|USE OF A NEW INFRARED CURE OVEN.
P040024|S083|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK|LMH|SU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/31/2015|12/15/2015|||APPR|APPROVAL FOR A NEW SUPPLIER OF RAW HYALURONIC ACID (HTLBIOTECHNOLOGY S.A.S., FRANCE).
P100040|S025|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|04/22/2016|||APPR|Approval for 1) a site change for inspection and packaging/shipping of delivery system components; 2) addition of a visual inspection process; and 3) change in a detergent for machining operations.
P070027|S044|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM|MIH|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|04/22/2016|||APPR|Approval for 1) a site change for inspection and packaging/shipping of delivery system components; 2) addition of a visual inspection process; and 3) change in a detergent for machining operations.
P080020|S018|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/31/2015|11/25/2015|||APPR|APPROVAL FOR A CHANGE TO THE MANUFACTURING AND STORING OF GEL-ONE® TO ALLOW FOR THE REFRIGERATION (5°C ± 3°C) OF IN-PROCESS PRODUCT (I.E. PRODUCT THAT HAS NOT YET BEEN PACKAGED AND LABELED) FOR A MAXIMUM OF 6 MONTHS FOLLOWING THE DATE OF TERMINAL STEAM STERILIZATION AND PRIOR TO INITIATION OF THE PRODUCT¿S PREVIOUSLY ESTABLISHED 12 MONTH SHELF LIFE WHEN STORED BELOW 25°C (WITHOUT FREEZING).
P840001|S312|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|12/21/2015|||APPR|APPROVAL FOR CHANGES TO THE H2 CATHODE MIX PROCESS USED TO MANUFACTURE BATTERIES FOR IMPLANTABLE DEVICES.
P860004|S236|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|12/21/2015|||APPR|APPROVAL FOR CHANGES TO THE H2 CATHODE MIX PROCESS USED TO MANUFACTURE BATTERIES FOR IMPLANTABLE DEVICES.
P960009|S237|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|12/21/2015|||APPR|APPROVAL FOR CHANGES TO THE H2 CATHODE MIX PROCESS USED TO MANUFACTURE BATTERIES FOR IMPLANTABLE DEVICES.
P970004|S204|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|12/21/2015|||APPR|APPROVAL FOR CHANGES TO THE H2 CATHODE MIX PROCESS USED TO MANUFACTURE BATTERIES FOR IMPLANTABLE DEVICES.
P080025|S099|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|12/21/2015|||APPR|APPROVAL FOR CHANGES TO THE H2 CATHODE MIX PROCESS USED TO MANUFACTURE BATTERIES FOR IMPLANTABLE DEVICES.
P140008|S001|APOLLO ENDOSURGERY INC|1120 S CAPITAL OF TX HWY|BLDG 1, STE 300|AUSTIN|TX|78746|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|ORBERA INTRAGASTRIC BALLOON SYSTEM|LTI|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|03/02/2016|||APPR|Approval for the change in venders of manufacturing materials used to mold components of the ORBERA Intragastric Balloon System.
P970003|S185|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2015|09/30/2015|||OK30|IMPLEMENTATION OF AN ALTERNATE SPOT WELDING SYSTEM USED DURING MANUFACTURE OF THE VNS THERAPY SYSTEM.
P050047|S050|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|Special (Immediate Track)||N|08/31/2015|09/30/2015|||APPR|APPROVAL FOR REVISED LABELING TO INCLUDE FDA¿S SUGGESTED VERBIAGE, VERBATIM, TO ENHANCE THE INFORMATION PROVIDED TO PATIENTS AND PHYSICIANS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.
P110033|S019|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|Special (Immediate Track)||N|08/31/2015|09/30/2015|||APPR|APPROVAL FOR REVISED LABELING TO INCLUDE FDA¿S SUGGESTED VERBIAGE, VERBATIM, TO ENHANCE THE INFORMATION PROVIDED TO PATIENTS AND PHYSICIANS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.
P060030|S048|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0|MZP|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|08/31/2015|02/18/2016|||APPR|Approval for use as an aid in the diagnosis of HCV infection.
P020014|S044|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/01/2015|05/12/2016|||APPR|Approval of changes to the post-approval study protocol.
P110016|S022|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),FLEXABILITY ABLATION CATHETERS (BI-DIRECTIONAL)|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2015|09/14/2015|||OK30|REDUCTION IN BACTERIAL ENDOTOXIN TESTING FREQUENCY FOR THE FLEXABILITY ABLATION CATHETERS MANUFACTURED IN PLYMOUTH, MN.
P910001|S080|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY LASER ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2015|09/30/2015|||OK30|CHANGE TO OPTICAL FIBER MANUFACTURING PROCESS.
P960004|S073|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROX ENDOCARDIAL PACING LOEADS & FINELINE II STEROX EZ ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2015|09/23/2015|||OK30|FINELINE II STEROX ENDOCARDIAL PACING LEADS
P130022|S001|NEVRO CORPORATION|1800 BRIDGE PARKWAY||REDWOOD CITY|CA|94065||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SENZA SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2015|10/02/2015|||OK30|MODIFICATION IN THE MANUFACTURING PROCESS OF THE CONNECTOR STACK SUB-ASSEMBLY.
P140023|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2015|09/24/2015|||OK30|APPROVAL OF GE HEALTHCARE SOURCED MATERIAL MANUFACTURED AT THE THERMOFISHER SCIENTIFIC FACILITY LOCATED IN VILNIUS, LITHUANIA AS AN APPROVED SUPPLIER OF POLYADENYLIC ACID POLYMER, POTASSIUM SALT (POLY A) FOR THE ROCHE MOLECULAR SYSTEMS FACILITY IN BRANCHBURG, NEW JERSEY.
P020004|S123|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS|MIH|CV|Panel Track|Change Design/Components/Specifications/Material|N|09/02/2015|02/29/2016|16M-0928|03/15/2016|APPR|Approval for the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device). This device is indicated for use with the GORE® EXCLUDER® AAA Endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy, including:  1) Adequate iliac/ femoral access; 2) Minimum common iliac diameter of 17 mm at the proximal implantation zone of the IBE; 3) External iliac artery treatment diameter range of 6.5 – 25 mm and seal zone length of at least 10 mm; 4) Internal iliac artery treatment diameter range of 6.5 – 13.5 mm and seal zone length of at least 10 mm; and 5) Adequate length from the lowest major renal artery to the internal iliac artery to accommodate the total endoprosthesis length, calculated by adding the minimum lengths of required components, taking into account appropriate overlaps between components.
P040024|S084|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2015|09/25/2015|||OK30|REBUILDING AIRLOCKS WITHIN THE RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE SILK, AND RESTYLANE LYFT MANUFACTURING FACILITY.
P970021|S043|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE II BALLOON CATHETER|MNB|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2015|10/02/2015|||OK30|CHANGES TO THE MANUFACTURING PROCESS, PROCESS SPECIFICATION FOR DRIVE ASSEMBLY, THERMACHOICE CATHETERS 3.0, FOR THE GYNECARE THERMACHOICE BALLOON CATHETER.
P040024|S085|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2015|09/25/2015|||OK30|REBUILDING OF THE MEDIA SYSTEMS WITHIN THE RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE SILK, AND RESTYLANE LYFT MANUFACTURING FACILITY.
P100033|S006|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Prostrate cancer genes nucleic acid amplification test system|PROGENSA PCA3 ASSAY|OYM|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2015|09/24/2015|||OK30|CHANGE IN SUPPLIER FOR THE MAGNETIC PARTICLES (CH0206) USED IN THE MANUFACTURE OF THE PROGENSA PCA3 ASSAY FROM THERMO FISHER SCIENTIFIC TO GE HEALTHCARE.
P960040|S354|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/02/2015|10/02/2015|||APPR|APPROVAL FOR DESIGN CHANGES TO THE NG3 AND NG2.5 HIGH VOLTAGE CAPACITORS FOR THE DEVICES.
P010012|S399|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/02/2015|10/02/2015|||APPR|APPROVAL FOR DESIGN CHANGES TO THE NG3 AND NG2.5 HIGH VOLTAGE CAPACITORS FOR THE DEVICES.
P060006|S070|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/02/2015|10/23/2015|||APPR|APPROVAL FOR LABELING CHANGES REGARDING MAGNETIC RESONANCE COMPATIBILITY AND REMOVAL OF THE FLUSHING NEEDLE FROM THE PRODUCT PACKAGING.
P140008|S002|APOLLO ENDOSURGERY INC|1120 S CAPITAL OF TX HWY|BLDG 1, STE 300|AUSTIN|TX|78746|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|ORBERA INTRAGASTRIC BALLOON SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Change Design/Components/Specifications/Material|N|09/03/2015|02/26/2016|||APPR|Approval of the post-approval study protocol.
P010030|S066|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2015|10/02/2015|||OK30|ALTERNATE SUPPLIER, SUN STAR, INC., IN LATROBE, PENNSYLVANIA FOR THE ECG BACKCOVER WITH RETAINER DUAL AND ECG BACK COVER WITH RETAINER SINGLE.
P020025|S079|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2015|10/01/2015|||OK30|INCREASED CAPACITY SHIPPING CARTONS AND AN INCREASED PALLET CONFIGURATION.
P080027|S021|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/03/2015|10/15/2015|||OK30|UPDATE TO WELD PARAMETERS AND MODIFICATIONS TO AUTOMATED WELDING EQUIPMENT.
P920047|S085|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS|LPB|CV|30-Day Notice||N|09/03/2015|10/01/2015|||OK30|INCREASED CAPACITY SHIPPING CARTONS AND AN INCREASED PALLET CONFIGURATION.
P040047|S042|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|10/01/2015|||OK30|LIFTING THE REQUIREMENT THAT MANUFACTURING EQUIPMENT REMAIN DEDICATED TO SPECIFIC PRODUCTS.
P000025|S082|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2015|12/03/2015|||APPR|APPROVAL FOR A CHANGE TO THE MAGNET MATERIAL USED TO MANUFACTURETHE MI1200 SYNCHRONY MAGNET ASSEMBLIES AND THE MI1200 REPLACEMENT MAGNETS. THE CHANGE IS INTENDED TO REPLACE THE CURRENTLY USED MAGNET MATERIAL WHICH IS DISCONTINUED BY THESUPPLIER.
P050037|S062|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|10/01/2015|||OK30|LIFTING THE REQUIREMENT THAT MANUFACTURING EQUIPMENT REMAIN DEDICATED TO SPECIFIC PRODUCTS.
P050052|S072|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, RADIESSE(+), RADIESSE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|10/01/2015|||OK30|LIFTING THE REQUIREMENT THAT MANUFACTURING EQUIPMENT REMAIN DEDICATED TO SPECIFIC PRODUCTS.
P110004|S013|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|10/02/2015|||OK30|A CHANGE TO YOUR STENT WELDING PROCESS.
P110013|S057|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|09/29/2015|||OK30|CHANGE TO THE INSPECTION PROCESS FOR THE RESOLUTE INTEGRITY DEVICE.
P110004|S014|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|10/01/2015|||OK30|CHANGE TO STENT WELDING EQUIPMENT.
P130022|S002|NEVRO CORPORATION|1800 BRIDGE PARKWAY||REDWOOD CITY|CA|94065||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SENZA SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/04/2015|12/02/2015|||APPR|APPROVAL FOR MINOR CHANGES IN THE SENZA SYSTEM IMPLANTABLE PULSE GENERATOR (IPG) AND TRIAL STIMULATION (TSM) FIRMWARE.
P980016|S548|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA  S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2015|10/29/2015|||APPR|APPROVAL FOR THREE NEW ALTERNATE ICS TO BE USED IN THE DEVICES.
P010031|S511|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Programmer, pacemaker|BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D|KRG|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/04/2015|10/29/2015|||APPR|APPROVAL FOR THREE NEW ALTERNATE INTEGRATED CIRCUITS TO BE USED IN THE DEVICES.
P020011|S009|GEN-PROBE|10210 GENETIC CENTER DR.||SAN DIEGO|CA|92121||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|APTIMA HCV RNA QUALITATIVE ASSAY|MZP|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|09/19/2016|||APPR|Approval of a new supplier for a critical raw material.
P930038|S078|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL|MGB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|09/30/2015|||APPR|APPROVAL FOR IMPLEMENTATION OF A SUTURE KNOT TEST INSPECTION.
P850079|S068|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|METHAFILCON A AND B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/04/2015|10/15/2015|||OK30|CHANGE IN MATERIAL (FINA) FOR THE BLISTER PACKAGING AND NEW SUPPLIER FOR THIS MATERIAL.
P930014|S085|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL,  ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2015|12/04/2015|||APPR|APPROVAL FOR THE ALCON ONLINE TORIC IOL CALCULATOR WHICH IS A MODIFICATION OF THE TORIC IOL CALCULATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALCON ONLINE TORIC IOL CALCULATOR FOR THE ACRYSOF® TORIC AND IQ TORIC IOLS. THE ACRYSOF® TORIC AND IQ TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INTENDED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION OF RESIDUAL REFRACTIVE CYLINDER AND INCREASED SPECTACLE INDEPENDENCE FOR DISTANCE VISION.
P890055|S061|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2015|10/08/2015|||OK30|CHANGES TO THE STERILIZATION PROCESS: 1) STEAM INJECTION RATE CURRENTLY AT 20 MBAR/MIN WILL CHANGE TO 5 MBAR/MIN; 2) GAS INJECTION RATE CURRENTLY AT 25 MBAR/MIN WILL CHANGE TO 20 MBAR/MIN; 3) MINIMUM PRIMARY DEGASSING TIME OF 10 HOURS WILL CHANGE TO 8 HOURS; 4) THE HANDLES FROM THE STERILIZATION SHIPPER, NUMBER 197548018, WILL BE REMOVED; 5) ADD A SECOND ETHYLENE OXIDE (EO) STERILIZATION CHAMBER (CHAMBER #4; 6) A MINIMUM EO STERILIZATION LOAD IN CHAMBER #3 (EXISTING CHAMBER) AND CHAMBER #4; AND 7) A 2X EO STERILIZATION FOR BOTH CHAMBER #3 AND #4.
P080009|S009|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/08/2015|10/08/2015|||APPR|APPROVAL FOR CHANGES TO THE CLINICAL USER GUIDE/ OPERATOR¿S MANUAL TO WARN AGAINST THE USE OF QUATERNARY AMMONIUM COMPOUND (QAC)-BASED DISINFECTANTS (SPECIFICALLY THOSE CONTAINING AMMONIUM CHLORIDES). ADDITIONALLY, AFFIXING TWO LABELS TO THE EXTERIOR OF THE DEVICE WHICH REITERATE THIS WARNING.
P000037|S043|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2015|10/05/2015|||OK30|THE ADDITION OF A COORDINATE MEASURING MACHINE.
P010023|S012|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|MAXUM SYSTEM|MPV|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2015|05/03/2016|||APPR|Approval for a manufacturing site located at Ototronix LLC, 5000 Township Parkway, St. Paul, Minnesota  to perform manufacturing and distribution.
P110035|S033|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2015|09/25/2015|||OK30|REMOVAL OF THE ALKALINE TANK AND SUBSEQUENT RINSE TANK FROM THE ELECTROPOLISHING PROCESS.
P040044|S066|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP)|MGB|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/09/2015|12/03/2015|||APPR|APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE YEAR TO TWO YEARS.
P140028|S002|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2015|10/02/2015|||OK30|ADDITION OF AN OPTIONAL OXIDE REMOVAL STEP DURING A MANUFACTURING INSPECTION.
P970008|S065|Urologix, LLC|14405 21ST AVENUE N.||MINNEAPOLIS|MN|55447|2000|SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY|UROLOGIX TARGIS SYSTEM|MEQ|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/29/2015|||APPR|APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT SPECTRUM PLASTICS GROUP IN MINNEAPOLIS, MINNESOTA.
P890003|S337|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P900061|S137|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|END CAP,UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P920015|S162|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DF-1 CONNECTOR PORT PIN PLUG,IS-1 CONNECTOR PORT PIN PLUG KIT,SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEA|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P830061|S122|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ADHESIVE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P010015|S280|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P080006|S084|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P090013|S199|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P120017|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MYOCARDIAL PACING LEAD|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P030017|S235|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM, PRECISION MONTAGE SPINAL CORD STIMULATOR SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/10/2015|04/28/2016|||APPR|addition of the PrecisionTM MontageTM MRI and PrecisionTM MontageTM System Components
P900056|S151|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR ROTATIONAL ANGOPLASTY SYSTEM GUIDEWIRE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/13/2015|||OK30|ADDITION OF A VACUUM PUMP ANTI-SURGE DEVICE TO THE EXISTING CHAMBER 1 EQUIPMENT AT THE CONTRACT STERILIZER.
P920047|S086|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/13/2015|||OK30|ADDITION OF A VACUUM PUMP ANTI-SURGE DEVICE TO THE EXISTING CHAMBER 1 EQUIPMENT AT THE CONTRACT STERILIZER.
P980003|S064|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/13/2015|||OK30|ADDITION OF A VACUUM PUMP ANTI-SURGE DEVICE TO THE EXISTING CHAMBER 1 EQUIPMENT AT THE CONTRACT STERILIZER.
P020025|S080|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/13/2015|||OK30|ADDITION OF A VACUUM PUMP ANTI-SURGE DEVICE TO THE EXISTING CHAMBER 1 EQUIPMENT AT THE CONTRACT STERILIZER.
P930039|S137|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P950024|S065|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/10/2015|10/02/2015|||OK30|IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.
P930039|S138|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|5076 CAPSUREFIX NOVUS SURESCAN LEADS|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/2015|09/11/2015|||APPR|APPROVAL OF THE EVERA MRI XT/S DR AND VR IMPLANTABLE CARDIOVERTERDEFIBRILLATOR DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW033 AS WELL AS EXTENSION OF MR CONDITIONAL LABELING AND USE FOR SPRINT QUATTRO SECURE LEAD MODELS 6935M AND 6947M AS MRI SURESCAN LABELED 55 AND 62CM LEADS. IN ADDITION TO THE SYSTEM COMPONENTS LISTED, THE USE OF THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI AND CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 WITH THE EVERA MRI DR (DUAL CHAMBER)SYSTEM WHEN AN ATRIAL PACE/SENSE LEAD IS INDICATED. FURTHERMORE, YOU REQUESTED APPROVAL TO USE CARELINK MONITOR MODEL 2490C, CARELINK EXPRESS MONITOR 2020B, CARDIOSIGHT READER MODEL2020A, MYCARELINK MONITOR MODEL 24950 AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) MODEL 2491 TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE EVERA MRI DEVICES.
P090013|S200|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|5086 MRI CAPSUREFIX MRI SURESCAN LEADS|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/16/2015|09/11/2015|||APPR|APPROVAL OF THE EVERA MRI XT/S DR AND VR IMPLANTABLE CARDIOVERTERDEFIBRILLATOR DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW033 AS WELL AS EXTENSION OF MR CONDITIONAL LABELING AND USE FOR SPRINT QUATTRO SECURE LEAD MODELS 6935M AND 6947M AS MRI SURESCAN LABELED 55 AND 62CM LEADS. IN ADDITION TO THE SYSTEM COMPONENTS LISTED, THE USE OF THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI AND CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 WITH THE EVERA MRI DR (DUAL CHAMBER)SYSTEM WHEN AN ATRIAL PACE/SENSE LEAD IS INDICATED. FURTHERMORE, YOU REQUESTED APPROVAL TO USE CARELINK MONITOR MODEL 2490C, CARELINK EXPRESS MONITOR 2020B, CARDIOSIGHT READER MODEL2020A, MYCARELINK MONITOR MODEL 24950 AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) MODEL 2491 TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE EVERA MRI DEVICES.
N16837|S021|ARTEGRAFT, INC.|206-208B NORTH CENTER DRIVE||NORTH BRUNSWICK|NJ|08902||TISSUE GRAFT OF 6MM AND GREATER|ARTEGRAFT COLLAGEN VASCULAR GRAFT|LXA|CV|Real-Time Process||N|09/11/2015|01/19/2016|||APPR|APPROVAL FOR INCLUDING A NON-ANTIGENIC STATEMENT IN THE INSTRUCTIONS FOR USE.
P140015|S001|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Sensor, glucose, invasive|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2015|10/08/2015|||OK30|ADD A SECOND INSULIN CARTRIDGE ASSEMBLY PRODUCTION LINE.  THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.
P060022|S022|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS INTRAOCULAR LENS|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2015|03/11/2016|||APPR|Approval for the addition of an alternate packaging component supplier for the Akreos Plastic Vial Components.
P140015|S002|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Sensor, glucose, invasive|T SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2015|10/08/2015|||OK30|ADDITION OF A SECOND CARTRIDGE LASER WELD SUBASSEMBLY PRODUCTION LINE.  THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.
P140015|S003|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Sensor, glucose, invasive|TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM.|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2015|10/08/2015|||OK30|ADDITION OF A SECOND INSULIN CARTRIDGE TEST SYSTEM (CTS).  THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.
P030017|S236|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2015|10/09/2015|||OK30|PROCESS CHANGE TO THE WELDING PROCESS FOR ATTACHING THE BATTERY TO THE KOVAR TABS ON THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) DURING THE MANUFACTURE OF IMPLANTABLE PULSE GENERATOR (IPG) DEVICES.
P140015|S004|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Sensor, glucose, invasive|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/11/2015|10/08/2015|||OK30|ADDITION OF A SECOND HEAD-TO-BAG INSULIN CARTRIDGE SUBASSEMBLY TEST SYSTEM.  THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.
P970051|S134|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|COCHLEAR IMPLANT|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2015|10/14/2015|||OK30|ADDITION OF REWORK AND INSPECTION STEPS TO MANUFACTURING PROCEDURES AT THE MACQUARIE MANUFACTURING FACILITY.
P840001|S313|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2015|10/14/2015|||OK30|NEW LASER WELDING EQUIPMENT FOR YOUR SPINAL CORD STIMULATION (SCS) AND DEEP BRAIN STIMULATION (DBS SYSTEMS).
P960009|S238|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2015|10/14/2015|||OK30|NEW LASER WELDING EQUIPMENT FOR YOUR SPINAL CORD STIMULATION (SCS) AND DEEP BRAIN STIMULATION (DBS SYSTEMS).
P060040|S044|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2015|10/14/2015|||OK30|ADDITION OF AN ALTERNATE SUPPLIER FOR A CRITICAL COMPONENT IN THE HEARTMATE II LVAS POCKET CONTROLLER.
P100025|S010|OTSUKA AMERICA PHARMACEUTICAL, INC.|2440 RESEARCH BLVD.||ROCKVILLE|MD|20850||Test, urea adult and pediatric (breath),|BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA|OZA|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/15/2015|01/27/2016|||APPR|APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND THE HOW TO GUIDE FOR THE BREATHTEK® UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA).
P140003|S006|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA 2.5 SYSTEM|OZD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/15/2015|11/03/2015|||APPR|APPROVAL FOR AN UPGRADE OF THE AUTOMATED IMPELLA CONTROLLER (AIC)SOFTWARE TO VERSION 5.0.
P910023|S362|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+, FAMILY OF ICDS|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2015|05/12/2016|||APPR|Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.
P030054|S292|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE/+/RF/Q,PROMOTE ACCEL,PROMOTE QUADRA,UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA,EPIC+/HF/HF+/IIHF/II+HF,ATLAS+|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2015|05/12/2016|||APPR|Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.
P030035|S139|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ALLURE/RF, QUADRA ALLURE/RF FAMILY OF CRT-PS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2015|05/12/2016|||APPR|Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.
P880086|S261|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY PACEMAKERS|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/15/2015|05/12/2016|||APPR|Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.
P010032|S101|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|TRIPOLE, TRIPOLE 16C, TRIPOLE 16, LAMITRODE 4, LAMITRODE 44, LAMITRODE S-4, LAMITRODE S-8, LAMITRODE 88, LAMITRODE WINGE|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2015|10/15/2015|||OK30|IMPLEMENTATION OF A CHANGE TO THE TUMBLING PROCESS OF ELECTRODES USED ON THE SCS LEADS, EXTENSIONS, AND ADAPTERS.
P100009|S013|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2015|10/15/2015|||OK30|CHANGES TO THE CLEANROOM CLASSIFICATION.
P010023|S013|OTOTRONIX, LLC|26620 I-45 NORTH||HOUSTON|TX|77386||Implant, hearing, active, middle ear, partially implanted|SOUNDTECH DIRECT AND MAXUM|MPV|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2015|03/22/2016|||APPR|Approval for a test fixture and inspection process change for the Magnet Canister Assembly (MCA).
P980016|S549|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI XT DR SURESCAN ICD, EVERA MRI XT VR SURESCAN ICD,EVERA MRI S DR SURESCAN ICD, EVERA MRI S VR SURESCAN ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2015|10/14/2015|||OK30|MANUFACTURING CHANGES: EXPANSION OF A CONTROLLED ENVIRONMENT AREA, ADDITION OF A LASER WELDING SYSTEM, UPDATE TO HYBRID TRACKING DURING MANUFACTURING, CONNECTOR MOLDING MANUFACTURING PROCESS CHANGE, ADDITION OF A SOAK OVEN TEMPERATURE VERIFICATION, AND IMPLEMENTATION OF A CONTINUOUS MONITORING SYSTEM.
P030053|S031|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL BREAST IMPLANT|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/16/2015|02/12/2016|||APPR|Approval of the following changes to the post-approval study for the device: to enroll women with both MemoryGel and MemoryShape in a single study to address device specific and device class safety endpoints and updates to the study timeline.
P060028|S013|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYSHAPE BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/16/2015|02/12/2016|||APPR|Approval of the following changes to the post-approval study for the device: to enroll women with both MemoryGel and MemoryShape in a single study to address device specific and device class safety endpoints and updates to the study timeline.
P960040|S355|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, DYNAGEN ICD, INOGEN ICD, ORIGEN ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2015|10/07/2015|||OK30|MANUFACTURE THE SPRING CONNECTOR BLOCK HOUSING COMPONENTS FOR THE REFERENCED PULSE GENERATORS AT BOSTON SCIENTIFIC CORPORATION FACILITY, ST. PAUL, MN
P910023|S363|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2015|10/07/2015|||OK30|ADDITION OF AN ALTERNATE FEEDTHRU SUPPLIER FOR HIGH VOLTAGE CAPACITORS UTILIZED IN THE DEVICES.
P960004|S074|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROX IMPLANTABLE CARDIAC ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2015|10/13/2015|||OK30|INSOURCING BOSTON SCIENTIFIC CORPORATION AS A MANUFACTURER FOR THE MOLDED SILICONE SLIT SUTURE SLEEVE ACCESSORY.
P010012|S400|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||INCEPTA CRT D, ENERGEN CRT D, PUNCTUA CRT-D, DYNAGEN CRT-D, INOGEN CRT D, ORIGEN CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2015|10/07/2015|||OK30|MANUFACTURE THE SPRING CONNECTOR BLOCK HOUSING COMPONENTS FOR THE REFERENCED PULSE GENERATORS AT BOSTON SCIENTIFIC CORPORATION FACILITY, ST. PAUL, MN
P030054|S293|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2015|10/07/2015|||OK30|ADDITION OF AN ALTERNATE FEEDTHRU SUPPLIER FOR HIGH VOLTAGE CAPACITORS UTILIZED IN THE DEVICES.
P110042|S050|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD )|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2015|10/07/2015|||OK30|MANUFACTURE THE SPRING CONNECTOR BLOCK HOUSING COMPONENTS FOR THE REFERENCED PULSE GENERATORS AT BOSTON SCIENTIFIC CORPORATION FACILITY, ST. PAUL, MN
P000012|S054|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV TEST VERSION 2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2015|10/15/2015|||OK30|ELIMINATION OF AN IN-PROCESS FUNCTIONAL TEST FOR A FINAL COMPONENT.
P090013|S201|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/17/2015|10/07/2015|||OK30|WELDING PROCESS CHANGE, FROM A MANUAL WELDING PROCESS TO A SEMI-AUTOMATED WELDING PROCESS FOR THE HEDIX SUBASSEMBLY OF THE ABOVE REFERENCED LEAD SYSTEMS.
P930039|S139|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVY|CV|30-Day Notice||N|09/17/2015|10/07/2015|||OK30|WELDING PROCESS CHANGE, FROM A MANUAL WELDING PROCESS TO A SEMI-AUTOMATED WELDING PROCESS FOR THE HEDIX SUBASSEMBLY OF THE ABOVE REFERENCED LEAD SYSTEMS.
P010013|S066|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||DEVICE, THERMAL ABLATION, ENDOMETRIAL|NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM.|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|09/17/2015|10/27/2015|||APPR|APPROVAL FOR SOFTWARE CHANGES TO THE NOVASURE MODEL 10 RADIOFREQUENCY CONTROLLER.
P140020|S003|MYRIAD GENETIC LABORATORIES|320 Wakara Way||Salt Lake City|UT|84108||Cancer-related germline gene mutation detection system|BRACANALYSIS CDX|PJG|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/17/2015|11/18/2015|||APPR|APPROVAL FOR CLARIFICATIONS TO THE INTENDED USE STATEMENT, AS FOLLOWS:BRACANALYSIS CDX IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION AND CLASSIFICATION OF VARIANTS IN THE PROTEIN CODING REGIONS AND INTRON/EXON BOUNDARIES OF THE BRCA1 AND BRCA2 GENES USING GENOMIC DNA OBTAINED FROM WHOLE BLOOD SPECIMENS COLLECTED IN EDTA. SINGLE NUCLEOTIDE VARIANTS AND SMALL INSERTIONS AND DELETIONS (INDELS) ARE IDENTIFIED BY POLYMERASE CHAIN REACTION (PCR) AND SANGER SEQUENCING. LARGE DELETIONS AND DUPLICATIONS IN BRCA1 AND BRCA2 ARE DETECTED USING MULTIPLEX PCR. RESULTS OF THE TEST ARE USED AS AN AID IN IDENTIFYING OVARIAN CANCER PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA VARIANTS, WHO ARE OR MAY BECOME ELIGIBLE FOR TREATMENT WITH LYNPARZA (OLAPARIB). THIS ASSAY IS FOR PROFESSIONAL USE ONLY AND IS TO BE PERFORMED ONLY AT MYRIAD GENETIC LABORATORIES, A SINGLE LABORATORY SITE LOCATED IN SALT LAKE CITY, UTAH.
P140008|S003|APOLLO ENDOSURGERY INC|1120 S CAPITAL OF TX HWY|BLDG 1, STE 300|AUSTIN|TX|78746|0000|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|ORBERA INTRAGASTRIC BALLOON  SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2015|05/23/2016|||APPR|approval for a manufacturing site located at Apollo Endosurgery, Building 13.3, Zona Franca Coyol, Alajuela, Costa Rica
P140015|S005|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Sensor, glucose, invasive|TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2015|10/15/2015|||OK30|REMOVAL OF A NON-DESTRUCTIVE TEST AND A MOVE OF AN EXISTING DESTRUCTIVE TEST TO AN EARLIER POINT IN THE MANUFACTURING PROCESS OF THE T:SLIM INSULIN CARTRIDGE.  THE INSULIN CARTRIDGE IS A DISPOSABLE COMPONENT OF THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM.
P040024|S086|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L, PERLANE,  RESTYLANE SILK, RESTYLANE LYFT, INJECTABLE GELS.|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2015|02/04/2016|||APPR|Approval for a change in control of the starting material (sodium hyaluronate).
P110006|S006|U-SYSTEMS, INC.|9900 WEST INNOVATIVE DRIVE|MAIL STOP RP2138|WAUWATOSA|WI|53226||Automated breast ultrasound|INVENIA ABUS  --  AUTOMATED BREAST ULTRASOUND SYSTEM|PAA|RA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2015|10/15/2015|||OK30|CHANGES IN SUPPLIERS FOR 12 CRITICAL PARTS, TO IMPROVE THE PARTS' QUALITY, PRODUCTIVITY, AND DELIVERY.  THE COMMON CHARACTERISTIC OF ALL 12 PARTS IS THEIR ELECTRICAL CONDUCTIVITY ON SPECIFIED SURFACES, TO ALLOW ELECTRICAL CONTINUITY FOR PROPER GROUNDING OF YOUR DEVICE.  THE PROPOSED CHANGES DO NOT INVOLVE ANY CHANGES IN THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.
P140010|S010|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2015|10/15/2015|||OK30|AUTOMATED VISION INSPECTION SYSTEM.
P070027|S045|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2015|10/15/2015|||OK30|IMPLEMENTATION OF A NEW INTERNAL PROCESS CHALLENGE DEVICE (IPCD) INOCULATION METHOD FOR BIANNUAL STERILIZATION REQUALIFICATION.
N970012|S111|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, impotence, mechanical/hydraulic|AMS 700 INFLATABLE PENILE PROSTHESIS|FHW|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/18/2015|02/03/2016|||APPR|Approval for a change in supplier for poly(ethylene terephthalate) (PET) yarn resin and supplier.
P010019|S041|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2015|10/13/2015|||OK30|INTRODUCE AN ALTERNATE SOURCE OF ISOPROPYL ALCOHOL.
P000006|S045|COLOPLAST CORP.|1601 WEST RIVER ROAD NORTH||MINNEAPOLIS|MN|55411||Device, impotence, mechanical/hydraulic|TITAN INFLATABLE PENILE PROSTHESIS|FHW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2015|11/23/2015|||APPR|APPROVAL FOR CHANGES TO THE HYDROPHILIC COATING SPECIFICATIONS AND MANUFACTURING PROCESS.
P130021|S018|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|COREVALVE EVOLUT BIOPROSTHESIS, CORE VALVE BIOPROSTHESIS, ACCUTRAK DELIVERY CATHETER SYSTEM, GEN 3 & GEN4 COMPRESSION LO|NPT|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2015|01/25/2016|||APPR|APPROVAL FOR MODIFICATIONS TO THE ACCEPTANCE CRITERIA FOR THE PARAMETERS MEASURED BY THE MANUFACTURING FUNCTIONAL TESTER.
P130007|S009|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2015|10/21/2015|||OK30|TRANSFERRING THE GLUCOSE ENGINE RADIO FREQUENCY BOARD ASSEMBLY (GE ASSEMBLY) SCREENING TESTING TO THE SUPPLIER.  THE GE ASSEMBLY IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.
P010032|S102|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON CHARGING SYSTEM, EON MINI LE CHARGING SYSTEM, PRODIGY CHARGING SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|09/21/2015|12/18/2015|||APPR|APPROVAL FOR MODIFYING THE INTERNAL SWITCH MECHANISM OF THE IPG CHARGING DEVICE.
P140009|S005|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO LE CHARGING SYSTEM|MHY|NE|Real-Time Process||N|09/21/2015|12/18/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO, TIJUANA, BAJA CALIFORNIA, MEXICO.
P970031|S050|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|Special (Immediate Track)||N|09/21/2015|10/21/2015|||APPR|APPROVAL FOR THE ADDITION OF A PRECAUTION TO INSTRUCTIONS FOR USE LABELING.
N18033|S079|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2015|10/15/2015|||OK30|CHANGES TO THE SUPPLIER OF THE MOLD MATERIAL.
P860004|S237|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2015|10/21/2015|||OK30|ADDITION OF MEDTRONIC PUERTO RICO OPERATIONS CO. IN JUNCOS, PUERTO RICO.
P980046|S009|HOME ACCESS HEALTH CORP.|2401 W. HASSELL|SUITE 1510|HOFFMAN ESTATES|IL|60195|5200|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|HOME ACCESS HEPATITIS C CHECK|MZO|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/22/2015|12/09/2015|||APPR|APPROVAL FOR THE ALCON ONLINE TORIC IOL CALCULATOR WHICH IS A MODIFICATION OF THE TORIC IOL CALCULATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALCON ONLINE TORIC IOL CALCULATOR FOR THE ACRYSOF TORIC AND IQ TORIC IOLS. THE ACRYSOF TORIC AND IQ TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INTENDED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION OF RESIDUAL REFRACTIVE CYLINDER AND INCREASED SPECTACLE INDEPENDENCE FOR DISTANCE VISION.
P060038|S024|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)|LWR|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/22/2015|11/24/2015|||APPR|APPROVAL FOR REVISIONS TO THE MRI SAFETY LABELING.
P030017|S237|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2015|10/22/2015|||OK30|IMPLEMENTATION OF AN UPDATE TO THE TEST EQUIPMENT SYSTEM AND ASSOCIATED SOFTWARE USED FOR TESTING CONTINUITY AND HIPOT ON THE ARTISAN (2X8) SURGICAL (PADDLE) LEAD AND COVEREDGE 32 CONTACT SURGICAL (PADDLE) LEADS.
P960040|S356|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN EL ICD & MINI ICD, INOGEN EL ICD & MINI ICD; DYNAGEN EL ICD & MINI ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/19/2015|||OK30|CONVERT ONE SUPER OUTPUT MODULE (SOM) TO ANOTHER SOM BY SUBJECTING IT TO A TEMPERATURE CYCLE SCREENING PROCESS.
P010012|S401|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||ORIGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4 CRT-D; DYNAGEN CRT-D, X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS||CV|30-Day Notice||N|09/23/2015|10/19/2015|||OK30|CONVERT ONE SUPER OUTPUT MODULE (SOM) TO ANOTHER SOM BY SUBJECTING IT TO A TEMPERATURE CYCLE SCREENING PROCESS.
P120005|S039|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; DEXCON G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/23/2015|||OK30|REMOVAL OF AN IN-PROCESS INSPECTION TESTING PERFORMED DURING THE MANUFACTURING PROCESS OF THE G4 PLATINUM AND G5 MOBILE TRANSMITTERS.  THE G4 PLATINUM AND THE G5 MOBILE TRANSMITTERS ARE COMPONENTS OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM AND G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM, RESPECTIVELY.
P090018|S030|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/23/2015|03/18/2016|||APPR|Approval of the following changes to the post-approval study for your device:change in sample size, removal of blinded audiologists, removal of requirement for x-ray ofimplanted device, change in follow-up point of evaluation and data gathering for safety objective.
P960016|S057|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER, SAFIRE BI-DIRECTIONAL ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/21/2015|||OK30|TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
P110042|S051|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM S-ICD PULSE GENERATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/19/2015|||OK30|CHANGE TO THE RADII PROFILE MEASUREMENT METHOD FOR THE FRONT AND BACK CASES OF THE ABOVE REFERENCED DEVICE.
P040014|S027|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/21/2015|||OK30|TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
P040042|S032|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/21/2015|||OK30|TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
P060019|S034|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/21/2015|||OK30|TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
P110016|S023|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|FLEXABILITY ABLATION CATHETER, THERAPY COOL PATH DUO, SAFIRE BLU DUO, COOL PATH DUO, SAFIRE DUO, THERAPY COOL PATH DUO|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/21/2015|||OK30|TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
P130026|S010|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ CATHETER AND TACTISYSQUARTZ EQUIPMENT|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2015|10/21/2015|||OK30|TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
P090006|S016|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM- ILIAC|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2015|10/20/2015|||OK30|CHANGES TO THE MANUFACTURING EQUIPMENT USED IN ASSEMBLY OF THE COMPLETE SE VASCULAR STENT SYSTEM.
P110040|S008|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE VASCULAR STENT SYSTEM- SFA AND PPA|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2015|10/20/2015|||OK30|CHANGES TO THE MANUFACTURING EQUIPMENT USED IN ASSEMBLY OF THE COMPLETE SE VASCULAR STENT SYSTEM.
P070027|S046|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2015|10/23/2015|||OK30|CHANGE IN THE INOCULATION PROCESS SITE FOR STERILIZATION REQUALIFICATION.
P110019|S078|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/24/2015|10/22/2015|||OK30|CHANGE TO THE ACCEPTANCE SAMPLING SYSTEM FOR DISLODGEMENT TESTING FOR THE XIENCE PRIME AND XIENCE PRIME II EVEROLIMUS ELUTING CORONARY STENT SYSTEM.
P010031|S513|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA MRI/COMPIA MRI QUAD CRT-D SURESCAN|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2015|02/01/2016|||APPR|Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
P080006|S085|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY MRI , PLUS MRI,STRAIGHT MRI SURESCAN; ATTAIN PERFORMA MRI, STRAIGHT ANS S MRI SURESCAN|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2015|02/01/2016|||APPR|Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
P920015|S163|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE S MRI SURESCAN ; SPRINT QUATTRO SECURE MRI SURESCAN|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2015|02/01/2016|||APPR|Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
P930039|S140|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS MRI SURESCAN|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2015|02/01/2016|||APPR|Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
P090013|S202|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2015|02/01/2016|||APPR|Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
P890003|S338|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS MONITOR|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/24/2015|02/01/2016|||APPR|Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
P050052|S073|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE (+) 0.8CC, RADIESSE (+) 1.5CC|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2015|05/02/2016|||APPR|Approval for using an alternate supplier for the syringe barrels and assembly of the syringe components.
P110010|S116|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIMUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATIN|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2015|02/16/2016|||APPR|Approval for a change to add an alternate component supplier.
P100023|S123|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2015|02/16/2016|||APPR|Approval for a change to add an alternate component supplier.
P130030|S017|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2015|02/16/2016|||APPR|Approval for a change to add an alternate component supplier.
P100044|S018|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL MINI SINUS IMPLANT|OWO|EN|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|09/25/2015|03/23/2016|16M-1123|04/12/2016|APPR|Approval for the PROPEL Mini Sinus Implant is intended for use in patients >= 18 years of age following ethmoid/frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening. The PROPEL Mini Sinus Implant separates/dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
P120005|S040|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2015|11/25/2015|||APPR|APPROVAL FOR ADDING A SECOND MANUFACTURER FOR PRINTED CIRCUIT BOARD ASSEMBLIES TO BE USED IN THE DEXCOM G5 TRANSMITTER AND RECEIVER.
P020047|S063|ABBOTT VASCULAR|P.O. BOX 9018||TEMECULA|CA|92589|9018|STENT, CORONARY|MULTI-LINK VISION MULTI-LINK MINI-VISION AND MULTI-LINK 8|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2015|10/22/2015|||OK30|CHANGE TO THE STENT PROCESS MONITORING SYSTEM.
P100006|S001|BIOMIMETIC THERAPEUTICS,LLC|389 Nichol Mill Ln||FRANKLIN|TN|37067||Filler, bone void, synthetic peptide|AUGMENT BONE GRAFT|NOX|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2015|10/05/2015|||APPR|APPROVAL FOR PROPOSED EDITS TO THE PACKAGE INSERT.
P110019|S079|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, LL, XIENCE|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2015|10/22/2015|||OK30|A CHANGE TO THE STENT PROCESS MONITORING SYSTEM.
P060038|S025|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/28/2015|10/12/2015|||APPR|APPROVAL FOR EXTENDING THE SHELF LIFE FOR THE DEVICE FROM ONE YEAR TOTWO YEARS.
P120022|S012|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN EGFR RGQ PCR KIT|OWD|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2015|11/09/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN GMBH IN HILDEN, GERMANY.
P050047|S051|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM HYALURONATE GEL IMPLANTS|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2015|10/23/2015|||OK30|IMPLEMENTATION OF AN AUTOMATED VISUAL INSPECTION PROCESS AND ACCOMPANYING IN-PROCESS CONTROL FOR INSPECTING THE 0.8 ML SYRINGE CONFIGURATION OF JUVEDERM HYALURONATE GEL IMPLANTS.
P050033|S020|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Implant, dermal, for aesthetic use|HYDRELLE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/29/2015|10/22/2015|||APPR|APPROVAL FOR LABELING MODIFICATIONS, AS REQUESTED IN FDAS LETTER TO MANUFACTURERS MARKETING SOFT TISSUE FILLER IMPLANTS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.
P140012|S002|RESHAPE MEDICAL, INC.|100 CALLE IGLESIA||SAN CLEMENTE|CA|92672||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT|LTI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|09/28/2015|12/21/2015|||APPR|APPROVAL FOR 1) A NEW DELIVERY CATHETER GEN1; 2) PRODUCT PACKAGING FOR THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM; 3) EXTENSION OF THE BALLOON AND DELIVERY CATHETER ASSEMBLY TO 24 MONTHS; AND 4) A NEW SUPPLIER FOR THE DELIVERY CATHETER ASSEMBLY (MEDBIO, INC., IN GRAND RAPIDS, MICHIGAN).
P140028|S003|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2015|10/23/2015|||OK30|EQUIPMENT UPDATES ASSOCIATED WITH THE INNOVA STENT PROCESS.
P070015|S131|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/25/2015|10/22/2015|||OK30|A CHANGE TO THE STENT PROCESS MONITORING SYSTEM.
P030011|S035|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2015|10/29/2015|||OK30|AN ALTERNATE ASSEMBLER FOR CERTAIN FREEDOM DRIVER PRINTED CIRCUIT BOARD ASSEMBLIES.
P910023|S364|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2015|12/06/2015|||APPR|APPROVAL FOR THE MERLIN.NET MN5000 VERSION 7.3 SOFTWARE.
N970012|S112|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, impotence, mechanical/hydraulic|AMS 700 INFLATABLE PENILE PROSTHESIS|FHW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2015|10/30/2015|||OK30|CHANGES IN THE FABRIC WASH PROCESS WATER LEVEL RANGE, THE RINSE CYCLE PH TESTING, AND THE INSPECTION OF CUT FABRIC ANGLE MEASUREMENT.
P030054|S294|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE/+RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+HF,|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2015|12/06/2015|||APPR|APPROVAL FOR THE MERLIN.NET MN5000 VERSION 7.3 SOFTWARE.
P030035|S140|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ALLURE/RF, ALLURA QUADRA/RF FAMILY OF CRT-P'S|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2015|12/06/2015|||APPR|APPROVAL FOR THE MERLIN.NET MN5000 VERSION 7.3 SOFTWARE.
P880086|S262|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2015|12/06/2015|||APPR|APPROVAL FOR THE MERLIN.NET MN5000 VERSION 7.3 SOFTWARE.
P980037|S049|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SETS|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/30/2015|||OK30|A CHANGE IN THE BIOBURDEN ASSESSMENT.
P060028|S014|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|02/05/2016|||APPR|Approval for 1) change 100291296:  Update packaging processes with Alloyd Heat Sealers and Tyvek Pouch to implement the use of the Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices; and 2) change 100248737:  minor layout modifications to the gel fill area were made to increase operational efficiency.
P860057|S139|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/27/2015|||OK30|THE ADDITION OF A TERMINAL LIQUID STERILIZATION OVEN.
P130009|S041|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/27/2015|||OK30|THE ADDITION OF A TERMINAL LIQUID STERILIZATION OVEN.
P960040|S357|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/21/2015|||OK30|ELIMINATE AN EQUIPMENT CHECK PERFORMED ON EQUIPMENT USED TO TEST PARYLENE COATING THICKNESS OF BATTERIES AND CAPACITORS USED IN THE DEVICE MODELS.
P960022|S011|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2015|10/19/2015|||OK30|QUALIFYING AN ALTERNATE SUPPLIER OF A CRITICAL RAW MATERIAL COMPONENT FOR THE BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) CONTACT LENS.
P100009|S014|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/29/2015|||OK30|CHANGES TO THE CONNECTOR MANUFACTURING PROCESS.
P010012|S402|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNHRONIZATION THERAPY-DEFIBRILLATOR||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/21/2015|||OK30|ELIMINATE AN EQUIPMENT CHECK PERFORMED ON EQUIPMENT USED TO TEST PARYLENE COATING THICKNESS OF BATTERIES AND CAPACITORS USED IN THE DEVICE MODELS.
P110042|S052|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|GEN 2 S-ICD & SQ-RX PULSE GENERATOR,  SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFRILLATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/21/2015|||OK30|ELIMINATE AN EQUIPMENT CHECK PERFORMED ON EQUIPMENT USED TO TEST PARYLENE COATING THICKNESS OF BATTERIES AND CAPACITORS USED IN THE DEVICE MODELS.
P840001|S314|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL SPINAL CORD STIMULATION SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/30/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) AT MEDTRONIC TEMPE CAMPUS (MTC) IN TEMPE, ARIZONA.
P060037|S040|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/27/2015|||OK30|TO ADD A NEW CONTRACT LABORATORY TO INCREASE BIOLOGICAL INDICATOR VERIFICATION TESTING CAPACITY FOR THE LPS MOBILE TIBIAL ARTICULAR SURFACE COMPONENTS.
P860004|S238|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/30/2015|||OK30|TO UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) AT MEDTRONIC'S HYBRID SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), TEMPE, AZ.
P960009|S239|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/30/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) AT MEDTRONIC TEMPE CAMPUS (MTC) IN TEMPE, ARIZONA.
P970004|S205|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/30/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) AT MEDTRONICS HYBRID SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), TEMPE, ARIZONA.
P080025|S100|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/30/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) AT MEDTRONICS HYBRID SUPPLIER, MEDTRONIC TEMPE CAMPUS (MTC), TEMPE, ARIZONA.
P980016|S551|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VISIA AF VR , S VR, AFMRI VR SURESCAN, PROGRAMMER SOFTWARE, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS|LWS|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|01/19/2016|||APPR|APPROVAL FOR THE VISIA AF AND VISIA AF MRI SINGLE-CHAMBER (VR) ICD DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW035.
P980035|S440|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/23/2015|||OK30|REMOVAL OF VARIOUS VISUAL INSPECTIONS AND RE-ORDERING OF STEPS IN THE WORK INSTRUCTIONS IMPLEMENTED IN THE AUTOMATIC LINE OF FINAL PACKAGING.
P890003|S339|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR , CARDIOSIGHT READER, CARELINK EXPRESS MONITOR|NVZ|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|01/19/2016|||APPR|APPROVAL FOR THE VISIA AF AND VISIA AF MRI SINGLE-CHAMBER (VR) ICD DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW035.
P090013|S203|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/23/2015|||OK30|REMOVAL OF VARIOUS VISUAL INSPECTIONS AND RE-ORDERING OF STEPS IN THE WORK INSTRUCTIONS IMPLEMENTED IN THE AUTOMATIC LINE OF FINAL PACKAGING.
P010031|S515|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/23/2015|||OK30|REMOVAL OF VARIOUS VISUAL INSPECTIONS AND RE-ORDERING OF STEPS IN THE WORK INSTRUCTIONS IMPLEMENTED IN THE AUTOMATIC LINE OF FINAL PACKAGING.
P920015|S164|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE S MRI SURESCAN LEAD,  SPRINT QUATTRO SECURE MRI SURESCAN LEAD|LWS|CV|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|01/19/2016|||APPR|APPROVAL FOR THE VISIA AF AND VISIA AF MRI SINGLE-CHAMBER (VR) ICD DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW035.
P980016|S552|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT ICD,MAXIMO II ICD, PROTECTA ICD, PROTECT XT ICD,SEC|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/23/2015|||OK30|REMOVAL OF VARIOUS VISUAL INSPECTIONS AND RE-ORDERING OF STEPS IN THE WORK INSTRUCTIONS IMPLEMENTED IN THE AUTOMATIC LINE OF FINAL PACKAGING.
P920015|S165|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/30/2015|||OK30|MANUFACTURING TRANSFER TO A DIFFERENT INTERNAL SUPPLIER FOR THE DEXAMETHASONE ACETATE (DXAC) MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) COMPONENT USED IN THE ABOVE REFERENCED DEVICE.
P930039|S141|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/30/2015|||OK30|MANUFACTURING TRANSFER TO A DIFFERENT INTERNAL SUPPLIER FOR THE DEXAMETHASONE ACETATE (DXAC) MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) COMPONENT USED IN THE ABOVE REFERENCED DEVICE.
P100044|S019|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL AND PROPEL MINI SINUS IMPLANTS|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/28/2015|||OK30|ADDING AN INCOMING QUALITY ASSURANCE TEST FOR SHRINKAGE OF THE FIBER COMPONENTS OF THE PROPEL AND PROPEL MINI PRODUCTS AND TO INCREASE THE UPPER LIMIT FOR THE INHERENT VISCOSITY (IV) MANUFACTURING LOT RELEASE SPECIFICATION TO MATCH THE UPPER LIMIT FOR THE CURRENT IV DESIGN SPECIFICATION.
P010015|S282|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CTR-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/22/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) TO FACTORY WORKS 9.1, IMPM MES WEB SERVICES 3.0.0, AND OTHER ASSOCIATED CHANGES.
P010031|S514|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,BRAVA QUARD CRT-D,CONCERTO II CRT-D, CONSULTA CRT-D,MAXIMOII CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/22/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) TO FACTORY WORKS 9.1, IMPM MES WEB SERVICES 3.0.0, AND OTHER ASSOCIATED CHANGES.
P090013|S204|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/22/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) TO FACTORY WORKS 9.1, IMPM MES WEB SERVICES 3.0.0, AND OTHER ASSOCIATED CHANGES.
P980016|S553|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD, EVERA S DR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTS ICD, PROTECTS XT ICD, SECURA IC|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/22/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) TO FACTORY WORKS 9.1, IMPM MES WEB SERVICES 3.0.0, AND OTHER ASSOCIATED CHANGES.
P980035|S441|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/22/2015|||OK30|UPDATE THE MANUFACTURING EXECUTION SYSTEM (MES) TO FACTORY WORKS 9.1, IMPM MES WEB SERVICES 3.0.0, AND OTHER ASSOCIATED CHANGES.
N970012|S113|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, impotence, mechanical/hydraulic|AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS|FHW|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/14/2015|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS THAT ADD INSPECTION STEPS TO THE BLUNT NEEDLE ACCESSORY.
P000053|S061|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM|EZY|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/14/2015|||APPR|APPROVAL FOR CHANGES IN QUALITY CONTROLS THAT ADD INSPECTION STEPS TO THE BLUNT NEEDLE ACCESSORY.
P090022|S025|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD,SOFTEC I,SOFTEC HD PS AND  SOFTEC HDO|HQL|OP|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2015|10/20/2016|||APPR|Approval of a new raw material production method for the device molding.
P060040|S045|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2015|11/03/2015|||OK30|TO MODIFY THE MOLD USED TO PRODUCE THE HEARTMATE II POCKET CONTROLLER CASES.
P000013|S012|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRIDENT|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2015|11/05/2015|||OK30|THE ADDITION OF A CMM MACHINE.
P100009|S015|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP NT CLIP DELIVERY SYSTEM|NKM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/01/2015|05/10/2016|||APPR|Approval for a material change to the gripper, design and manufacturing changes to the delivery system, and changes to device packaging.
P980037|S050|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2015|11/02/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED IN FREMONT, CALIFORNIA FOR FINISHED DEVICE RELEASE TEST, PACKAGING AND LABELING.
P950039|S034|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSORS|MKQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|10/01/2015|01/11/2016|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE THINPREP 5000 PROCESSOR.
P100006|S002|BIOMIMETIC THERAPEUTICS,LLC|389 Nichol Mill Ln||FRANKLIN|TN|37067||Filler, bone void, synthetic peptide|AUGMENT BONE GRAFT|NOX|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|09/30/2015|03/16/2016|||APPR|Approval of the protocol for the ODE Lead PMA Post-Approval Study.
P100006|S003|BIOMIMETIC THERAPEUTICS,LLC|389 Nichol Mill Ln||FRANKLIN|TN|37067||Filler, bone void, synthetic peptide|AUGMENT BONE GRAFT|NOX|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/30/2015|10/06/2016|||APPR|Approval  for termination of the New Enrollment Postapproval Study.
P100029|S021|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|TRIFECTA VALVE WITH GLIDE TECHNOLOGY|LWR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/02/2015|04/24/2016|||APPR|Approval for the addition of the Trifecta Valve with Glide Technology (Trifecta GT).
P010014|S052|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/02/2015|10/30/2015|||APPR|APPROVAL FOR AN UPDATE TO ITS PROCESS ENGINEERING SPECIFICATION THAT CONTROLS THE SEALING PARAMETERS FOR THE STERILE PACKAGING FOR THE OXFORD PARTIAL KNEE SYSTEM.
P020036|S035|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|CORDIS S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2015|11/05/2015|||OK30|A CHANGE TO THE MANUFACTURING LOCATION OF YOUR SUPPLIER FOR THE INTERNAL PACKAGING POUCHES.
P120002|S011|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|CORDIS S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2015|11/05/2015|||OK30|A CHANGE TO THE MANUFACTURING LOCATION OF YOUR SUPPLIER FOR THE INTERNAL PACKAGING POUCHES.
P030026|S031|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2015|11/03/2015|||OK30|A CHANGE FOR THE INTRODUCTION OF A NEW PIECE OF MANUFACTURING EQUIPMENT TO PACK COATED WELLS INTO REAGENT PACKS.
P970021|S044|GYNECARE, INC.|P.O. BOX 151||SOMMERVILLE|NJ|08876|0151|DEVICE, THERMAL ABLATION, ENDOMETRIAL|GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM|MNB|OB|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/06/2015|01/04/2016|||APPR|APPROVAL FOR CHANGES TO THE GYNECARE THERMACHOICE III UBT LABELS, INSTRUCTIONS FOR USE, OPERATING MANUAL, AND PATIENT LABELING.
P860004|S239|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2015|11/04/2015|||OK30|APPROVAL TO RELOCATE THE SUPPLIER MANUFACTURING FACILITY FOR THE ROTOR ASSEMBLY AND THE FINISHED MOTOR COMPONENT OF THE SYNCHROMED II MOTOR APPROVED UNDER P860004/S217 AS WELL AS REPLACE EXISTING EQUIPMENT (LASER MARKING EQUIPMENT AND TOOL MAKER'S MICROSCOPE) IN THE MOTOR MANUFACTURING PROCESS.
P100026|S038|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2015|11/05/2015|||OK30|THE USE OF AN ALTERNATE EPOXY ADHESIVE (EPOXY TECHNOLOGY EPO-TEK 301 EPOXY) DURING THE MANUFACTURING OF A COMPONENT FOR THE DEPTH AND CORTICAL STRIP LEADS.
P990021|S003|CONCORDIA LABORATORIES, INC|5 CANEWOOD INDUSTRIAL PARK||ST MICHAEL||BB110||SYSTEM, LASER, PHOTODYNAMIC THERAPY|PHOTOFRIN 630 PDT LASER|MVF|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/06/2015|06/28/2016|||APPR|Approval for the PHOTOFRIN 630 PDT Laser manufactured by Modulight, Inc located in Tampere, Finland.
P010032|S103|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EXTERNAL PULSE GENERATOR, 2 PORT HEADER|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2015|11/05/2015|||OK30|IMPLEMENTATION OF UPDATES TO THE TEST EQUIPMENT AND MEASUREMENT TECHNIQUES USED DURING THE MANUFACTURING PROCESS OF THE MICRO HDMI CONNECTOR OF THE SJM EPG HEADER MODEL 3032.
P990056|S022|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY|MTF|IM|30-Day Notice||N|10/07/2015|11/24/2015|||OK30|CHANGE IN THE TESTING PROCEDURE FOR THE STREPTAVIDIN-COATED MICROPARTICLES COMPONENT USED AS THE SOLID PHASE IN ELECSYS IMMUNOASSAYS.
P990012|S023|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P000027|S021|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|ELECSYS FREE PSA IMMUNOASSAY|MTG|IM|30-Day Notice||N|10/07/2015|11/24/2015|||OK30|CHANGE IN THE TESTING PROCEDURE FOR THE STREPTAVIDIN-COATED MICROPARTICLES COMPONENT USED AS THE SOLID PHASE IN ELECSYS IMMUNOASSAYS.
P010054|S025|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P100031|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P100032|S010|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P110022|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P110025|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P990027|S020|TECHNOLAS PERFECT VISION GMBH|MESSERSCHMITTSTR 1 + 3||MUNCHEN||80992||Excimer laser system|TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI|LZS|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/05/2015|||OK30|THE REPLACEMENT OF THE SUPPLIER OF ONE COMPONENT OF YOUR TREATMENT CARD BY TWO OTHER SUPPLIERS.
P110031|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC-IGM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P090007|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P090008|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P090009|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P130015|S004|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBEAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P140021|S001|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0416|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV II|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/24/2015|||OK30|A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
P010014|S053|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/20/2015|||OK30|THE ADDITION OF APPROVED MANUFACTURING COOLANTS DURING PRODUCTION OF COMPONENTS.
P010032|S104|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS/EON/EONC/EON MINI/PROTEGE SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/06/2015|||OK30|TO USE AN ALTERNATIVE BATCH TEST METHOD FOR ENDOTOXIN MONITORING FOR THE GENESIS/EON/EONC/EON MINI/PROTEGE/BRIO FAMILIES OF DEVICES.
P140009|S006|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO SYSTEMS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/06/2015|||OK30|TO USE AN ALTERNATIVE BATCH TEST METHOD FOR ENDOTOXIN MONITORING FOR THE GENESIS/EON/EONC/EON MINI/PROTEGE/BRIO FAMILIES OF DEVICES.
P080011|S039|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY XR TORIC|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2015|11/06/2015|||OK30|THE IMPLEMENTATION OF A NEW LATHING PROCESS STEP IN (MADE TO ORDER (MTO)) PRODUCTION LINE 1.
P140031|S003|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/07/2015|01/26/2016|||APPR|APPROVAL FOR VARIOUS DESIGN AND MANUFACTURING CHANGES TO THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, MODEL 9600TFX, INCLUDING CHANGE IN MATERIAL SPECIFICATION FOR THE POLYETHYLENE TEREPHTHALATE (PET) RIBBON, CHANGE IN SUTURE MATERIAL, AND REDUCTION IN THE NUMBER OF PERMANENT STITCHES.
P790002|S033|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET EBI BONE HEALING SYSTEM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2015|11/06/2015|||OK30|IMPLEMENTATION OF A NEW SOLDER REFLOW OVEN IN THE PRODUCTION OF THE PRINTED CIRCUIT BOARDS FOR THE DEVICES ABOVE.
P790005|S052|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2015|11/06/2015|||OK30|IMPLEMENTATION OF A NEW SOLDER REFLOW OVEN IN THE PRODUCTION OF THE PRINTED CIRCUIT BOARDS FOR THE DEVICES ABOVE.
P850022|S026|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2015|11/06/2015|||OK30|IMPLEMENTATION OF A NEW SOLDER REFLOW OVEN IN THE PRODUCTION OF THE PRINTED CIRCUIT BOARDS FOR THE DEVICES ABOVE.
P850035|S039|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF- XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS & SPF PLUS MINI SPINAL FUSION STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2015|11/06/2015|||OK30|IMPLEMENTATION OF A NEW SOLDER REFLOW OVEN IN THE PRODUCTION OF THE PRINTED CIRCUIT BOARDS FOR THE DEVICES ABOVE.
P010032|S105|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON, EONC, EON MINI PROTEGE, PROTEGE MRI IMPLANTABLE PULSE GENERATORS (IPG'S)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2015|11/06/2015|||OK30|ACCEPTANCE OF THE ADDITION OF AN ALTERNATE SUPPLIER FOR THE IMPLANTABLE PULSE GENERATOR (IPG) WELD LEVEL SUB-ASSEMBLIES.
P140009|S007|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO IMPLANTABLE PULSE GENERATORS (IPG'S)|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/08/2015|11/06/2015|||OK30|ACCEPTANCE OF THE ADDITION OF AN ALTERNATE SUPPLIER FOR THE IMPLANTABLE PULSE GENERATOR (IPG) WELD LEVEL SUB-ASSEMBLIES.
P060040|S046|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LVAS SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/08/2015|10/19/2015|||APPR|APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE REGARDING CHECKING THE EXPIRATION DATE OF AND REPLACING THE BACKUP BATTERY CONTAINED ON THE POCKET CONTROLLER.
P030031|S071|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMOCOOL, THERMOCOOL SF NAV, THERMOCOOL SMARTTOUCH|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|11/05/2015|||OK30|THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.
P040036|S053|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|11/05/2015|||OK30|THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.
P010031|S516|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D,BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D, EVERA MRI ICD||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|10/29/2015|||OK30|A CHANGE TO THE HIGH VOLTAGE CAPACITOR WELD MONITORING FREQUENCY.
P990025|S047|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|NAVISTAR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|11/05/2015|||OK30|THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.
P010068|S049|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|CELSIUS, CELSIUS FLTR, NAVISTAR DS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|11/05/2015|||OK30|THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.
P980016|S554|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|10/29/2015|||OK30|A CHANGE TO THE HIGH VOLTAGE CAPACITOR WELD MONITORING FREQUENCY.
P950005|S059|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS DS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|11/05/2015|||OK30|THE ADDITION OF AN ALTERNATE LOCATION FOR A PLASMA ETCHING PROCESS, IN ADDITION TO THE QUALIFICATION OF A NEWER EQUIPMENT MODEL FOR THAT SAME MANUFACTURING PROCESS.
P970003|S186|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER|MUZ|NE|30-Day Notice||N|10/09/2015|11/20/2015|||OK30|USE OF A NEW HELIUM LEAK TESTER IN THE MANUFACTURING PROCESS OF PULSE GENERATORS.
P020045|S068|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOBLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC CR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|11/12/2015|||OK30|CHANGES TO SMART CHIP PROGRAMMING EQUIPMENT AND VERIFICATION.
P100010|S051|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYOBLATION CATHETER; ARCTIC FRONT CARDIAC CRYOBLATION CATHETER; ARCTIC FRONT ADVANCE CARDIAC CRYOBL|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|11/12/2015|||OK30|CHANGES TO SMART CHIP PROGRAMMING EQUIPMENT AND VERIFICATION.
P080011|S040|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/09/2015|11/06/2015|||OK30|MANUFACTURING CHANGE TO MODIFY THE LENS TRANSFER PROCESS FOR THE MANUFACTURE OF THE BIOFINITY (COMFILCON A) TORIC CONTACT LENSES APPROVED UNDER THE ORIGINAL PMA.
P970051|S135|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|COCHLEAR CI500 SERIES IMPLANTS|MCM|EN|30-Day Notice||N|10/13/2015|11/12/2015|||OK30|NEW SUPPLIER AND A CHANGE IN THE UPPER TOLERANCE SPECIFICATION OF THE 25 MICRON PLATINUM IRIDIUM WIRE.
P830063|S008|BAXTER INTERNATIONAL, INC.|1 BAXTER PKWY.||DEERFIELD|IL|60015|4633|Separator for therapeutic purposes, membrane automated blood cell/plasma|GAMBRO PRISMAFLEX TPE 2000 SET|MDP|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2015|11/12/2015|||APPR|APPROVAL FOR A LABELING CHANGE TO ADDRESS COMPLAINTS RELATED TO LUER CONNECTOR CRACKS.
P970031|S051|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/04/2015|||OK30|THE ADDITION OF THREE NEW PORCINE TISSUE SUPPLIERS.
P990064|S061|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|MOSAIC PORCINE BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/04/2015|||OK30|THE ADDITION OF THREE NEW PORCINE TISSUE SUPPLIERS.
P980043|S052|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/04/2015|||OK30|THE ADDITION OF THREE NEW PORCINE TISSUE SUPPLIERS.
P870078|S030|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/04/2015|||OK30|THE ADDITION OF THREE NEW PORCINE TISSUE SUPPLIERS.
P790007|S046|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALUED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/04/2015|||OK30|THE ADDITION OF THREE NEW PORCINE TISSUE SUPPLIERS.
P840001|S315|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/12/2015|||OK30|THE UPDATE OF MANUFACTURING PROCESS CHANGES IN THE SURFACE TREATMENT OF METAL PIECE PART FOR THE IMPACTED IMPLATABLE PRODUCTS (I.E., TITANIUM, PLATINUM/IRIDIUM ALLOY, AND STAINLESS STEEL SUBCOMPONENTS) AS WELL AS MINOR UPDATES TO THE SURFACE TREATMENT SPECIFICATIONS FOR THESE SUBCOMPONENTS.
P860004|S240|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/10/2015|||OK30|UPDATE OF MANUFACTURING PROCESS CHANGES IN THE SURFACE TREATMENT OF METAL PIECE PART FOR THE IMPACTED IMPLANTABLE PRODUCTS (I.E., TITANIUM, PLATINUM/IRIDIUM ALLOY, AND STAINLESS STEEL SUBCOMPONENTS) AS WELL AS MINOR UPDATES TO THE SURFACE TREATMENT SPECIFICATIONS FOR THESE SUBCOMPONENTS.
P960009|S240|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/12/2015|||OK30|THE UPDATE OF MANUFACTURING PROCESS CHANGES IN THE SURFACE TREATMENT OF METAL PIECE PART FOR THE IMPACTED IMPLATABLE PRODUCTS (I.E., TITANIUM, PLATINUM/IRIDIUM ALLOY, AND STAINLESS STEEL SUBCOMPONENTS) AS WELL AS MINOR UPDATES TO THE SURFACE TREATMENT SPECIFICATIONS FOR THESE SUBCOMPONENTS.
P970004|S206|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/10/2015|||OK30|THE UPDATE OF MANUFACTURING PROCESS CHANGES IN THE SURFACE TREATMENT OF METAL PIECE PART FOR THE IMPACTED IMPLANTABLE PRODUCTS (I.E., TITANIUM, PLATINUM/IRIDIUM ALLOY, AND STAINLESS STEEL SUBCOMPONENTS) AS WELL AS MINOR UPDATES TO THE SURFACE TREATMENT SPECIFICATIONS FOR THESE SUBCOMPONENTS.
P140028|S004|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA (TM) VASCULAR SELF EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/09/2015|||OK30|THE ADDITION OF EQUIPMENT TO YOUR MANUFACTURING PROCESS.
P080025|S101|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2015|11/10/2015|||OK30|THE UPDATE OF MANUFACTURING PROCESS CHANGES IN THE SURFACE TREATMENT OF METAL PIECE PART FOR THE IMPACTED IMPLANTABLE PRODUCTS (I.E., TITANIUM, PLATINUM/IRIDIUM ALLOY, AND STAINLESS STEEL SUBCOMPONENTS) AS WELL AS MINOR UPDATES TO THE SURFACE TREATMENT SPECIFICATIONS FOR THESE SUBCOMPONENTS.
P980016|S555|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN  ICDS AND PROGRAMMER SOFTWARE|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2015|04/28/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Advisa and Evera SureScan Systems to 3T MRI.
P980035|S442|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE|NVZ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2015|04/28/2016|||APPR|Approval for expansion of MRI conditional labeling for the Advisa and Evera SureScan systems to 3T MRI.
P920015|S166|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M,SPRINT QUATTRO SECURE  MRI SURESCAN LEAD MODEL 6947M|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2015|04/28/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Advisa and Evera SureScan systems to 3T MRI.
P930039|S142|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076|NVY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2015|04/28/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Advisa and Evera SureScan systems to 3T MRI.
P090013|S205|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/13/2015|04/28/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Advisa and Evera SureScan systems to 3T MRI.
P080012|S030|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|10/13/2015|01/12/2016|||APPR|APPROVAL FOR UPDATING THE PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM SOFTWARE TO VERSION 1.03.2. THE SOFTWARE UPDATE CONSOLIDATES THE CONFIGURATION DEVICE SOFTWARE WITH THE CLINICIAN PROGRAMMER.
P890003|S340|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MY CARE-LINK SMART MONITOR PATIENT READER|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2015|11/04/2015|||OK30|THE ADDITION OF A SECONDARY SYSTEM LEVEL TEST AFTER FINAL ASSEMBLY AT THE SUPPLIER.
P110042|S053|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM S-ICD PULSE GENERATOR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2015|11/04/2015|||OK30|TO ADD AN ADDITIONAL SUPPLIER FOR NICKEL FOIL USED IN THE BATTERY ASSEMBLY.
P040024|S087|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2015|11/06/2015|||OK30|A REBUILD OF THE MANUFACTURING LINE L3 CLEAN ROOMS AT Q-MED'S FACILITY 2 IN UPPSALA, SWEDEN.
P910061|S022|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFPORT/SOFLEX INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/15/2015|11/05/2015|||OK30|CHANGING THE TENSILE FORCE TO BREAK SPECIFICATION, ADDING AN ELONGATION TO BREAK SPECIFICATION, AND ADJUSTING THE SAMPLING PLAN FOR OUR HAPTIC MATERIAL.
P060037|S041|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2015|11/12/2015|||OK30|ADDITION OF A NEW MATERIAL SUPPLIER.
P100042|S009|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2015|11/09/2015|||OK30|ADDITION OF A VIAL FILLER FOR USE IN MANUFACTURING AND EXPANSION OF FILL VOLUME SPECIFICATIONS.
P010030|S068|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2015|01/26/2016|||APPR|APPROVAL FOR AN ALTERNATE GEL FIRE POWER SWITCH AND HIGHER CAPACITYSD CARD ON THE LIFEVEST MODEL 4000.
P120007|S007|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV 16 18/45 GENOTYPE ASSAY|OYB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2015|11/09/2015|||OK30|ADDITION OF A VIAL FILLER FOR USE IN MANUFACTURING AND EXPANSION OF FILL VOLUME SPECIFICATIONS.
P890003|S341|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MY CARELINK PATIENT MONITOR MODEL 24950|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P980016|S556|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD, S DR, XT DR ICD, XT VR ICD, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT IC|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P980035|S443|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P010015|S283|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P830055|S164|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2015|11/12/2015|||OK30|ADDITION OF A TWO DIMENSIONAL (2D) BARCODE TO THE DISTAL POST OF THE LCS COMPLETE RP TIBIAL KNEE INSERTS AND CHANGES TO THE INSPECTION PROCESS.
P010031|S517|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D, QUAD CRT-D, CONCERTO OCD,CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, MAXIMO II CRT-D, PROTECT|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P090013|S206|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI, SURESCAN IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/16/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P030039|S019|BAXTER BIO SCIENCE|32650 N WILSON RD|MAIL STOP WG2-3S|ROUND LAKE|IL|60073||Sealant,polymerizing|COSEAL SURGICAL SEALANT, COSEAL REPLACEMENT APPLICATOR, COSEAL EXTENDED APPLICATOR|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/16/2015|11/24/2015|||OK30|A CHANGE IN RESIN USED IN THE MOLDING OF SEVERAL DELIVERY SYSTEM COMPONENTS.
P030016|S028|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/17/2015|||OK30|THE REPLACEMENT OF AN INSTRUMENT TO MEASURE DIOPTRIC POWER AND IMAGE QUALITY (MTF) AT FINAL PRODUCT INSPECTION.
P140028|S005|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA (TM) VASCULAR SELF-EXPANDING STENT  WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/16/2015|||OK30|THE ADDITION OF EQUIPMENT TO YOUR MANUFACTURING PROCESS.
P030011|S036|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/19/2015|12/09/2015|||APPR|APPROVAL FOR THE ADDITION OF TWO WARNINGS TO THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL.
P010031|S518|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D; PROTECTA CRT-D, PROTECTA XT CRT-D,||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/12/2015|||OK30|UPDATE TO THE MANUFACTURING TEST SOFTWARE FOR AN INTEGRATED CIRCUIT USED IN THE DEVICES.
P960016|S058|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/17/2015|||OK30|THE REPLACEMENT OF A MANUAL MEASURING PROCESS WITH AN AUTOMATED MEASURING SYSTEM.
P030017|S238|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/18/2015|||OK30|USE OF AN ALTERNATE DEGREASING CHEMICAL DURING THE VAPOR DEGREASING PROCESS OF THE SET SCREWS, END STOPS, AND FEED THROUGH BLANKS USED IN IPG HEADERS AND LEAD EXTENSIONS.
P930016|S046|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/19/2015|01/11/2016|||APPR|APPROVAL FOR CHANGES TO THE FRONT PANEL ASSEMBLY OF THE STAR S4 IR SYSTEM WITH RELATED CHANGES AND MINOR UPDATES TO THE STAR S4 IR OPERATORS MANUAL.
P980035|S444|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/12/2015|||OK30|UPDATE TO THE MANUFACTURING TEST SOFTWARE FOR AN INTEGRATED CIRCUIT USED IN THE DEVICES.
P010015|S284|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/12/2015|||OK30|UPDATE TO THE MANUFACTURING TEST SOFTWARE FOR AN INTEGRATED CIRCUIT USED IN THE DEVICES.
P980016|S557|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XI ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/12/2015|||OK30|UPDATE TO THE MANUFACTURING TEST SOFTWARE FOR AN INTEGRATED CIRCUIT USED IN THE DEVICES.
P120010|S073|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/18/2015|||OK30|TO USE A RECENTLY APPROVED SENSOR BASE COMPONENT ON MPROC (MEDTRONIC PUERTO RICO OPERATION COMPANY) ENLITE SENSORS MANUFACTURING LINE, TO INCREASE THE NUMBER OF COMPONENTS (BASES AND CAPS) TREATED PER PLASMA CLEANING CYCLE AND TO INCREASE POST-PLASMA SHELF LIFE THE THE TREATED COMPONENTS.  THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P030017|S239|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/18/2015|||OK30|THE USE OF AN ALTERNATE WELDER USED IN THE CONNECTOR STACK ASSEMBLY PROCESS OF YOUR IMPLANTABLE PULSE GENERATOR.
P110038|S010|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/18/2015|||APPR|APPROVAL FOR AN ADDITIONAL INSPECTION STEP OF THE RELEASE GRIP.
P850079|S069|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|FREQUENCY XCEL TORIC XR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/12/2015|||OK30|THE TRANSFER OF FREQUENCY XCEL TORIC XR (METHAFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES MANUFACTURING PROCESS FROM DRY LINE S TO DRY LINE 1.
P040002|S056|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA STENT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|11/18/2015|||OK30|AN ALTERNATE SUPPLIER TO PERFORM MICROBIOLOGICAL TESTING.
P100047|S066|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2015|12/10/2015|||OK30|IMPLEMENTATION OF A CONNECTOR ASSEMBLY FIXTURE, CONNECTOR GLUING FIXTURE, ADDITIONAL INSPECTIONS DURING THE MANUFACTURING PROCESS AND TO MOVE THE CONTINUITY TEST TO FURTHER IN THE MANUFACTURING PROCESS.
P050037|S063|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2015|12/11/2015|||APPR|APPROVAL FOR CHANGES IN PRODUCT LABELING ¿ UPDATE OF ADVERSE EFFECTS DESCRIPTIONS..
P050052|S074|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, RADIESSE (+) [RADIESSE WITH LIDOCAINE]|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/20/2015|12/11/2015|||APPR|APPROVAL FOR CHANGES IN PRODUCT LABELING ¿ UPDATE OF ADVERSE EFFECTS DESCRIPTIONS.
P060027|S079|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PLATINIUM CRT-D (MODELS 1711 AND 1741)|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/2015|07/07/2016|||APPR|Approval for Platinium ICDs and CRT-Ds.
P980049|S113|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PLATINIUM VR (MODELS 1210 AND 1240) AND PLATINIUM DR (MODELS 1510 AND 1540) ICDS|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/20/2015|07/07/2016|||APPR|Approval for Platinium ICDs and CRT-Ds.
P080012|S031|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE PUMP SYSTEM|LKK|HO|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|10/20/2015|12/28/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: A REVISION TO ALLOW FOR THE USE OF THE APPROVED PATIENT THERAPY CONTROLLER OR PTC IN THE POST-APPROVAL CLINICAL STUDY FOR THE PROMETRA IMPLANTABLE PROGRAMMABLE PUMP SYSTEM.
P930014|S086|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2015|11/19/2015|||OK30|CHANGE TO A NEW MEASUREMENT SYSTEM FOR QUALITY CONTROL INSPECTION OF OPTICAL PERFORMANCE OF YOUR ACRYSOF® MONOFOCAL AND TORIC IOLS AT THE IRELAND FACILITY (MODELS SA/N60WF, SA/N60AT, SN6AT3-T5).
P990075|S034|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|SALINE-FILLED & SPECTRUM BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2015|11/20/2015|||OK30|CHANGES IN THE MANUFACTURING PROCESS OF THE PRIMARY PACKAGING EQUIPMENT, AND DEFECT CLASSIFICATION OF THE PRIMARY PACKAGING VISUAL INSPECTION PROCEDURE.
P860004|S241|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2015|11/19/2015|||OK30|ADDITION OF A CO-ORDINATE MEASURING MACHINE (CMM).
P040020|S058|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF IQ RESTORE +3.0D ADD POWER INTRAOCULAR LENS|MFK|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|10/21/2015|01/06/2016|||APPR|APPROVAL FOR A DIOPTRIC POWER RANGE EXPANSION AND NEW METROLOGY INSTRUMENT FOR THE ACRYSOF® IQ RESTOR® INTRAOCULAR LENSES (IOLS).
P030053|S032|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2015|11/20/2015|||OK30|CHANGES IN THE MANUFACTURING PROCESS OF THE PRIMARY PACKAGING EQUIPMENT, AND DEFECT CLASSIFICATION OF THE PRIMARY PACKAGING VISUAL INSPECTION PROCEDURE.
P060028|S015|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2015|11/20/2015|||OK30|CHANGES IN THE MANUFACTURING PROCESS OF THE PRIMARY PACKAGING EQUIPMENT, AND DEFECT CLASSIFICATION OF THE PRIMARY PACKAGING VISUAL INSPECTION PROCEDURE.
P100047|S067|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/22/2015|11/20/2015|||OK30|IMPLEMENTATION OF A VISUAL INSPECTION SYSTEM FOR LABELS.
P890003|S342|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MYCARELINK PATIENT MONITOR MODEL 24950|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P980035|S445|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|11/25/2015|||APPR|APPROVAL FOR THE L409 IC DESIGN AND ASSOCIATED MANUFACTURINGCHANGES, WHICH IS USED IN THE DEVICES.
P980016|S559|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUISI II DR/VR ICD|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|11/25/2015|||APPR|APPROVAL FOR THE L409 IC DESIGN AND ASSOCIATED MANUFACTURINGCHANGES, WHICH IS USED IN THE DEVICES.
P010015|S286|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|11/25/2015|||APPR|APPROVAL FOR THE L409 IC DESIGN AND ASSOCIATED MANUFACTURINGCHANGES, WHICH IS USED IN THE DEVICES.
P010031|S519|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT XT CRT-D|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|11/25/2015|||APPR|APPROVAL FOR THE L409 IC DESIGN AND ASSOCIATED MANUFACTURINGCHANGES, WHICH IS USED IN THE DEVICES.
P890003|S343|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK HOME MONITOR 2490C|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|01/13/2016|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE CARELINK HOME MONITOR 2490C.
P110037|S023|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST|PAB|MI|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|10/22/2015|05/20/2016|||APPR|Approval for use with hematopoietic stem-cell transplant patients and to increase the whole blood stability claim in the Package Insert.
P980016|S558|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD, MARQUIS, SECURA, MAXIMO II, INTRINSIC,PROTECTA, PROTECTA XT, VIRTUOSO II|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P980035|S446|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA, ADVISA, ADVISA MRI, ENPULSE, KAPPA IPGS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P010015|S285|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P010031|S520|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VIVA, BRAVA, PROTECTA XT, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II, INSYNC II PROTECT|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P980016|S560|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ,EVERA, MARQUIS, SECURA, MAXIMO II, INTRINSIC, PROTECTA, PROTECTA XT, VIRTUOSO|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|01/13/2016|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE CARELINK HOME MONITOR 2490C.
P090013|S207|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI, SURESCAN IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|12/08/2015|||APPR|APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
P010031|S521|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA, BRAVA QUAD, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II,PROTECTA, PROTECTA XT, VIVA QUAD, VIVA S, VIVA XT|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/22/2015|01/13/2016|||APPR|APPROVAL FOR SOFTWARE MODIFICATIONS TO THE CARELINK HOME MONITOR 2490C.
P980025|S003|CARESTREAM DENTAL LLC|1765 THE EXCHANGE||ATLANTA|GA|30339||Analyzer,medical image|LOGICON CARIES DETECTOR|MYN|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2015|12/10/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARESTREAM DENTAL IN ATLANTA, GEORGIA.
P030036|S080|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2015|11/18/2015|||OK30|CHANGES TO PASSIVATION PROCESS PARAMETER SETTINGS AND UPDATES TO SAMPLE SIZES USED FOR IN PROCESS/FINAL INSPECTION AT A SUPPLIER FOR SEVERAL COMPONENTS OF THE SUBJECT LEADS.
P090013|S208|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2015|11/18/2015|||OK30|CHANGES TO PASSIVATION PROCESS PARAMETER SETTINGS AND UPDATES TO SAMPLE SIZES USED FOR IN PROCESS/FINAL INSPECTION AT A SUPPLIER FOR SEVERAL COMPONENTS OF THE SUBJECT LEADS.
P920015|S167|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2015|11/18/2015|||OK30|CHANGES TO PASSIVATION PROCESS PARAMETER SETTINGS AND UPDATES TO SAMPLE SIZES USED FOR IN PROCESS/FINAL INSPECTION AT A SUPPLIER FOR SEVERAL COMPONENTS OF THE SUBJECT LEADS.
P930039|S143|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2015|11/18/2015|||OK30|CHANGES TO PASSIVATION PROCESS PARAMETER SETTINGS AND UPDATES TO SAMPLE SIZES USED FOR IN PROCESS/FINAL INSPECTION AT A SUPPLIER FOR SEVERAL COMPONENTS OF THE SUBJECT LEADS.
P970051|S136|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/23/2015|11/20/2015|||OK30|THE INTRODUCTION OF AN ADDITIONAL CLEANING STEP TO REMOVE PRIMER RESIDUE PRIOR TO CURING FROM THE WELD SURFACE OF THE NUCLEUS CI 500 SERIES IMPLANTS (NUCLEUS CI512 AND 522).
P000008|S035|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|05/23/2016|||APPR|approval for a manufacturing site located at Apollo Endosurgery, Building 13.3, Zona Franca Coyol, Alajuela, Costa Rica
P080012|S032|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE IMPLANTABLE PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|11/24/2015|||OK30|TO MODIFY THE MANUFACTURING PROCEDURE FOR THE PATIENT THERAPY CONTROLLER (PTC) TO REROUTE THE PTC'S POWER CABLE WITHIN THE ASSEMBLY TO PREVENT IT FROM DAMAGE.  ADDITIONALLY, UPDATE THE FINAL RELEASE TEST TO ADD A "BOLUS TEST" TO FURTHER VERIFY THE OPERATION OF THE PTC PRIOR TO RELEASE.
P030017|S240|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|11/24/2015|||OK30|USE OF AN UPDATED TEST EQUIPMENT SYSTEM USED FOR TESTING THE PRECISION SPECTRA REMOTE CONTROL USED TO SUPPORT THE PRECISION SPECTRA IPG AND THE FREELINK REMOTE CONTROL USED TO SUPPORT BOTH PRECISION SPECTRA AND PRECISION NOVI IPGS.
P960013|S078|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS LEAD|NVN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|04/28/2016|||APPR|Approval for the reassessment of microbiological levels for cleanrooms.
P960030|S040|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ISOFLEX OPTIM|NVN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|04/28/2016|||APPR|Approval for the reassessment of microbiological levels for cleanrooms.
P950022|S089|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA, DURATA, OPTISURE|NVY|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|04/28/2016|||APPR|Approval for the reassessment of microbiological levels for cleanrooms.
P970013|S067|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|MICRONY|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|04/28/2016|||APPR|Approval for the reassessment of microbiological levels for cleanrooms.
P030035|S141|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ALLURE, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|04/28/2016|||APPR|Approval for the reassessment of microbiological levels for cleanrooms.
P030054|S295|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADRA ASSURA, QUICKFLEX U, QUARTET|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|04/28/2016|||APPR|Approval for the reassessment of microbiological levels for cleanrooms.
P880086|S263|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|04/28/2016|||APPR|Approval for the reassessment of microbiological levels for cleanrooms.
P910023|S365|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2015|04/28/2016|||APPR|Approval for the reassessment of microbiological levels for cleanrooms.
P100021|S050|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-LLIAC (AUI) STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2015|11/24/2015|||OK30|IMPLEMENTATION OF AN IN-PROCESS INSPECTION USING AN AUTOMATIC PICK COUNTER DURING THE KITTING PROCESS TO INSPECT THE PICKS PER INCH (PPI) OF THE RECOVERED GRAFT MATERIALS.
P970003|S187|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY MODEL 303 LEAD|MUZ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2015|11/25/2015|||OK30|ADDITION OF ALTERNATE WELD PARAMETERS FOR THE MODEL 303 IMPLANTABLE LEAD FOR THE VNS THERAPY® SYSTEM.
N12159|S035|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FAMILY OF ABSORBABLE HEMOSTATS|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2015|11/27/2015|||OK30|IMPLEMENT A NEW CUSTOM DESIGNED PIECE OF AUTOMATED CUTTING EQUIPMENT TO CUT THE PRODUCT TO ITS FINAL FORM.
P140010|S011|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2015|11/23/2015|||OK30|THE USE OF AN ELECTRONIC SYSTEM AS AN ALTERNATE TO A PAPER-BASED SYSTEM FOR DETERMINING AND CONTROLLING MASTER LOT RECORDS (MLRS) AND SAMPLING BATCHES OR MLRS FOR THE PURPOSE OF LOT RELEASE TESTING.
P080009|S010|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|10/28/2015|01/26/2016|||APPR|APPROVAL FOR SOFTWARE CHANGES TO FIX ISSUES WITH WIRELESS PRINTING RELIABILITY.
P120023|S002|ACUFOCUS, INC.|32 DISCOVERY|SUITE 200|IRVINE|CA|92618||Implant, corneal, refractive|KAMRA INLAY|LQE|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/28/2015|10/07/2016|||APPR|Approval of incorporation of a new double tray packaging configuration in order to accommodate physicians' ease of use. The new packaging configuration has currently been validated for a 5-year shelf life. In addition, an alternate sterilization site, Sterigenics US LLC, has been validated for the proposed packaging.
P040024|S088|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE-L|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/29/2015|11/23/2015|||APPR|APPROVAL FOR ADDITIONAL LANGUAGE IN PATIENT AND PROVIDER LABELING REGARDING THE RISK OF INTRAVASCULAR INJECTION OF SOFT TISSUE FILLERS.
P040024|S089|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/29/2015|11/23/2015|||APPR|APPROVAL FOR ADDITIONAL LANGUAGE IN PATIENT AND PROVIDER LABELING REGARDING THE RISK OF INTRAVASCULAR INJECTION OF SOFT TISSUE FILLERS.
P970004|S207|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2015|11/20/2015|||OK30|DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN).
P080025|S102|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2015|11/20/2015|||OK30|DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN).
P840001|S316|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY & VECTRIS SPINAL CORD STIMULATION|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2015|11/20/2015|||OK30|DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN).
P860004|S242|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2015|11/20/2015|||OK30|DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN).
P960009|S241|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2015|11/20/2015|||OK30|DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN).
P950034|S043|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2015|12/03/2015|||OK30|A CHANGE IN THE SOFTWARE USED TO MANAGE AND PRINT BARCODES AND LABELS FOR THE SEPRAFILM ADHESION BARRIER DEVICE.
P000044|S033|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/29/2015|11/20/2015|||OK30|REPLACEMENT OF A RAW MATERIAL WITH AN EQUIVALENT MATERIAL AND TO ADD SUPPLIERS FOR THE NEW MATERIAL.
P030017|S241|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/29/2015|08/16/2016|||APPR|Approval for minor design changes to the Precision OR Cable and Extension used with the Precision SCS system, to be procured from alternate qualified supplier Onanon Inc. at Milpitas, California.
P060037|S042|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|11/23/2015|||OK30|THE ADDITION OF A NEW WATER GENERATOR.
P020024|S042|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER, AMPLATZER DUCT OCCLUDER II,|MAE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|02/24/2016|||APPR|Approval for a manufacturing site located at Sterigenics, in Willowbrook, Illinois.
P000039|S053|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER SEPTAL OCCLUDER|MAE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|02/24/2016|||APPR|Approval for a manufacturing site located at Sterigenics, in Willowbrook, Illinois.
P040040|S025|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER  MUSCULAR VSD OCCLUDER|MLV|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|02/24/2016|||APPR|Approval for a manufacturing site located at Sterigenics, in Willowbrook, Illinois.
P110016|S024|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|FLEXABILITY ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|02/24/2016|||APPR|Approval for a manufacturing site located at Sterigenics, in  Willowbrook, Illinois.
P960016|S059|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER|LPB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|02/24/2016|||APPR|Approval for a manufacturing site located at Sterigenics, in  Willowbrook, Illinois.
P980044|S028|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX|MOZ|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|01/27/2016|||APPR|APPROVAL FOR RELOCATION OF MANUFACTURING PROCESSES FOR SUPARTZ FX TO A NEW FACILITY WITHIN THE MANUFACTURING PLANT FOR THE PRODUCT, AS WELL AS A CONCURRENT CHANGE TO THE CONTAINER CLOSURE SYSTEM FOR THE PRODUCT.
P010001|S014|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|12/04/2015|||OK30|ADDITION OF ONE CLEAN ROOM CLASS 7 FOR THE CERAMIC COMPONENTS OF THE TRANSCEND HIP ARTICULATION SYSTEM.
P990046|S042|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE, OPEN PIVOT AORTIC VALVED GRAFT, OPEN PIVOT HEART VALVE-APEX, OPEN PIVOT HEART VALVE-AP360|LWQ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|10/30/2015|02/12/2016|||APPR|Approval to implement leaflet angle design specifications, an in-process inspection for leaflet angle, and modify the magnetic resonance labeling.
P130026|S011|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ ABLATION CATHETER|OAE|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/30/2015|02/24/2016|||APPR|Approval for a manufacturing site located at Sterigenics, in  Willowbrook, Illinois.
P920015|S168|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC MODEL 5019 HV SPLITTER/ADAPTOR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|10/30/2015|01/11/2016|||APPR|APPROVAL FOR THE NEXT GENERATION ANALYZER CABLE INTERFACE ACCESSORY.
P870076|S017|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM|KNH|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/02/2015|07/20/2016|||APPR|Approval to recover and repackage intact and unused Disposable Falope-Ring® Band Applicators, subject them to a second sterilization process, and make them available for sale and distribution.
P940016|S020|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|H.E.L.P. PLASMAT FUTURA SYSTEM|MMY|GU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2015|03/17/2016|||APPR|Approval for a change in manufacturer for your sodium chloride and acetate buffer solution bags.
P040037|S086|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2015|12/02/2015|||OK30|THE ADDITION OF A NEXT GENERATION MACHINE (THIRD GENERATION AUTOMATIC, TAPE, ALIGN, AND TRANSFER (ATAT)) USED IN THE MANUFACTURE OF THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE.
P130006|S025|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS  WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2015|12/02/2015|||OK30|THE ADDITION OF A NEXT GENERATION MACHINE (THIRD GENERATION AUTOMATIC, TAPE, ALIGN, AND TRANSER (ATAT)) USED IN THE MANUFACTURE OF THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE.
P050038|S027|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2015|12/02/2015|||OK30|CHANGES TO THE POLY/TYVEK POUCH PACKAGING USED IN BOTH ARISTA FLEXITIP XL AND FLEXITIP XL-R.  THESE CHANGES INCLUDED 1) REVISION TO POUCH SEALING PARAMETERS 2) ADDITION OF APPEARANCE CRITERIA AND REVISED TOLERANCES TO MANUFACTURED POUCH, AND 3) IMPLEMENTATION OF A NEW SEALER FOR THE FLEXITIP XL POUCH.
P040002|S057|ENDOLOGIX, INC.|11 STUDEBAKER||IRVINE|CA|92618||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|AFX ENDOVASCULAR AAA SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2015|12/02/2015|||OK30|AN INCREASE IN THE STERILIZATION LOAD CONFIGURATION.
P980022|S181|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP. PARADIGM REAL-TIME REVEL INSULIN PUMP.|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2015|02/01/2016|||APPR|Approval to implement a change in the material composition of the loaner pump interior paper foam tray used for packaging the pump, which is a component of the paradigm eal-time, paradigm real-time revel and MiniMed 530G Systems.
P120010|S074|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|11/02/2015|02/01/2016|||APPR|Approval to implement a change in the material composition of the loaner pump interior paper foam tray used for packaging the pump, which is a component of the paradigm real-time, paradigm real-time revel and MiniMed 530G Systems.
P040045|S052|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON.A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2015|11/17/2015|||OK30|THE IMPLEMENTATION OF AN ENHANCEMENT OF INJECTION MOLDING MACHINE (IMM) PROCESS CONDITIONS FOR THE VISTAKON (SENOFILCON A) BRAND CONTACT LENSES.
P840001|S317|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2015|12/03/2015|||OK30|PROCESS CHANGES TO THE BATTERY BURN-IN TESTING FOR THE RESTORE BATTERY USED IN YOUR SPINAL CORD STIMULATION SYSTEMS.
P010030|S069|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2015|12/03/2015|||OK30|ADDITION OF A NEW, OPTIONAL DISPENSING EQUIPMENT USED IN THE THERAPY ELECTRODE MANUFACTURING PROCESS.
P980022|S182|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2015|12/03/2015|||OK30|USE HARVESTED MOTORS WITH SEPARATED FLEX CABLES IN THE MANUFACTURE OF PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G INSULIN PUMPS.
P900033|S053|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE|MDD|SU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/03/2015|05/09/2016|||APPR|Approval of two new product sizes (i.e., 4cm x 4cm and 7cm x 7cm) and revised packaging that permits inclusion of a stapler and staples in the Integra Omnigraft Dermal Regeneration Matrix kit.  The device, as modified, will be marketed under the trade name Omnigraft Dermal Regeneration Matrix.
P120010|S075|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2015|12/03/2015|||OK30|USE HARVESTED MOTORS WITH SEPARATED FLEX CABLES IN THE MANUFACTURE OF PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G INSULIN PUMPS.
P980022|S183|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2015|06/03/2016|||APPR|Approval for changes to the pump case drive support cap assembly process and the automated adhesive dispensing process used in the pump case manufacturing process of the Paradigm family of insulin pumps (models 5xx and 7xx). Paradigm insulin pumps are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System and the MiniMed 530G System.
P120016|S017|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2015|03/24/2016|||APPR|Approval for the implementation of additional equipment used to manufacture the key fusing subassembly.
P120010|S076|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2015|06/03/2016|||APPR|Approval for changes to the pump case drive support cap assembly process and the automated adhesive dispensing process used in the pump case manufacturing process of the Paradigm family of insulin pumps (models 5xx and 7xx). Paradigm insulin pumps are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System and the MiniMed 530G System.
P090016|S018|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/2015|12/11/2015|||APPR|APPROVAL FOR CHANGES IN PRODUCT LABELING-  UPDATE TO THE POST-MARKET SURVEILLANCE INFORMATION, FURTHER CLARIFICATION REGARDING ADVERSE EVENTS AND INFORMATION REGARDING TREATMENTS TO POSTMARKET SURVEILLANCE SECTION
P980022|S184|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP; PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2015|12/04/2015|||OK30|CHANGE FROM A MANUAL TO AUTOMATED PROCESS OF ASSEMBLING THE MOTOR GEARBOX OF THE PARADIGM REAL-TIME INSULIN PUMP AND PARADIGM REAL-TIME REVEL INSULIN PUMP. THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL SYSTEMS, RESPECTIVELY.
P100047|S068|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2015|12/03/2015|||OK30|IMPLEMENTATION OF AN UPGRADED COMPUTER FOR THE CO-ORDINATEMEASURING MACHINE (TS00261-01).
P030017|S242|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION NOVI SPI|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2015|12/04/2015|||OK30|UPDATES TO THE WELDING SCHEDULE FOR RESISTANCE WELDING OF THE DISTAL END OF SPLITTERS, ADAPTORS, AND LEAD EXTENSIONS.
P010012|S403|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D, ORIGEN CRT-D & X4 CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2015|11/19/2015|||OK30|AUTOMATION OF THE STERILE PACKAGING PROCESS.
P960040|S358|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN EL, INOGEN EL, DYNAGEN EL ICD'S ; ORIGEN MINI, INOGEN MINI, DYNAGEN MINI ICD'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2015|11/19/2015|||OK30|AUTOMATION OF THE STERILE PACKAGING PROCESS.
N970003|S183|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2015|11/19/2015|||OK30|AUTOMATION OF THE STERILE PACKAGING PROCESS.
P030005|S130|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INGENIO 2 CRT-P, VALITUDE & VALTITUDE X4 CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2015|11/19/2015|||OK30|AUTOMATION OF THE STERILE PACKAGING PROCESS.
P110042|S055|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2015|11/19/2015|||OK30|AUTOMATION OF THE STERILE PACKAGING PROCESS.
P060038|S026|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|Crown PRT Aortic Pericardial Heart Valve with PR Treatment|LWR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/04/2015|01/13/2016|||APPR|APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL DL, NAMELY THE ADDITION OF RADIOGRAPHIC MARKERS ON THE SEWING RING AND ADDITION OF VISIBLE MARKERS ON THE SEWING CUFF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CROWN PRT AORTIC PERICARDIAL HEART VALVE WITH PR TREATMENT AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
P120011|S002|IDEALIMPLANT|5005 LBJ FREEWAY SUITE 900||DALLAS,|TX|75244||Prosthesis, breast, inflatable, internal, saline|IDEAL IMPLANT SALINE FILLED BREAST IMPLANT|FWM|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|11/04/2015|04/25/2016|||APPR|Approval for a change to the currently approved brand name of IDEAL IMPLANT® Saline-filled Breast Implant to IDEAL IMPLANT® Structured Breast Implant.
P070014|S048|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEMS|NIP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/04/2015|03/11/2016|||APPR|Approval of a 250 mm stent length.
P140010|S012|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2015|01/06/2016|||APPR|APPROVAL OF AN ALTERNATE BUILDING FOR THE END ITEM MANUFACTURING LINE AND ASSOCIATED WORKSTEPS.
P980037|S051|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA XMI THROMBECTOMY SET, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMOBECTOMY SET|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/05/2015|12/02/2015|||OK30|TO ESTABLISH AN ALTERNATE VENDOR, BOSTON SCIENTIFIC CORPORATION MAPLE GROVE, FOR THE PUMP SUB-ASSEMBLY COMPONENT OF THE ANGIOJET ULTRA THROMBECTOMY SYSTEM.
P010032|S106|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON, EONC, EON MINI, PROTEGE, PROTEGE MRI INPLANTABLE PULSE GENERATORS (IPGS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2015|12/04/2015|||OK30|MINOR MODIFICATION ON THE AUTOMATED MANUFACTURING TEST SOFTWARE FOR BOTH SPINAL CORD STIMULATION AND THE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATORS.
P140009|S008|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO IMPLANTABLE PULSE GENERATORS (IPGS)|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2015|12/04/2015|||OK30|MINOR MODIFICATION ON THE AUTOMATED MANUFACTURING TEST SOFTWARE FOR BOTH SPINAL CORD STIMULATION AND THE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATORS.
P820033|S009|Asahi Kasei Medical Co., Ltd.|1-105 KANDA JINBOCHO|CHIYODA-KU|TOKYO||101-8|8101|Separator for therapeutic purposes, membrane automated blood cell/plasma|PLASMAFLO|MDP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2015|12/03/2015|||OK30|ADD A NEW VENDOR FOR THE BROMINATED POLYCARBONATE RAW MATERIAL IN THE MANUFACTURE OF THE COMPONENTS OF THE PLASMAFLOTM OP-05 W (A) ASAHI PLASMA SEPARATOR.
P910056|S021|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2015|12/04/2015|||OK30|IMPLEMENT A BULK EXTRACTION AND HYDRATION PROCESS FOR THE MODEL MX60 IOLS.
P140028|S006|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/06/2015|11/30/2015|||OK30|THE REMOVAL OF STENT OUTER DIAMETER AND LENGTH INSPECTIONS FOR THE INNOVA STENT SYSTEM.
P980037|S052|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA XMI THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/09/2015|||OK30|A CHANGE IN VENDOR FOR THE WASTE BAG SUB-ASSEMBLY AND THE BAG SPIKE SUB-ASSEMBLY.
P010032|S107|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI (IMPLANTABLE PULSE GENERATOR) IPG, PROTEGE IPG, PROTEGE IPG MRI|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/09/2015|||OK30|REMOVAL OF A DUPLICATE INSPECTION PROCEDURE AND CHANGES TO MINIMAL TOLERANCES FOR BATTERIES USED IN YOUR IMPLANTABLE PULSE GENERATORS.
P140009|S009|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO IPG|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/09/2015|||OK30|REMOVAL OF A DUPLICATE INSPECTION PROCEDURE AND CHANGES TO MINIMAL TOLERANCES FOR BATTERIES USED IN YOUR IMPLANTABLE PULSE GENERATORS.
P010012|S404|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112|||DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/07/2015|||OK30|ADDITION OF A NEW MANUFACTURING INSPECTION TO VERIFY THE POLARITY OF THE DISCRETE CAPACITOR ARRAY COMPONENT ON THE PRINTED CIRCUIT BOARD.
P960040|S359|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN ICD, INOGEN ICD, ORIGEN ICD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/07/2015|||OK30|ADDITION OF A NEW MANUFACTURING INSPECTION TO VERIFY THE POLARITY OF THE DISCRETE CAPACITOR ARRAY COMPONENT ON THE PRINTED CIRCUIT BOARD.
P960042|S052|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SLS II AND GLIDELIGHT  LASER SHEATH KITS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/03/2015|||OK30|A MODIFICATION TO THE ETHYLENE OXIDE (EO) STERILIZATION PROCESS.
P100026|S039|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/09/2015|||OK30|ADDITION OF A CLEANING STEP AND CLEANING SOLUTION TO THE MANUFACTURING PROCESS THAT PRODUCES THE LEAD RING MARKER.
P980022|S188|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP &  PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/09/2015|||OK30|APPROVAL FOR UPDATING THE INSPECTION SPECIFICATIONS OF THE DRIVE SUPPORT DISK CAP OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL AND MINIMED 530G INSULIN PUMPS CASE SURFACE.  THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL AND MINIMED 530G INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL AND MINIMED 530G SYSTEMS.
P120010|S079|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/09/2015|||OK30|APPROVAL FOR UPDATING THE INSPECTION SPECIFICATIONS OF THE DRIVE SUPPORT DISK CAP OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL AND MINIMED 530G INSULIN PUMPS CASE SURFACE.  THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL AND MINIMED 530G INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL AND MINIMED 530G SYSTEMS.
P980022|S186|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME SYSTEM,PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/09/2015|||OK30|TO MAKE CHANGES IN THE INCOMING INSPECTION CRITERIA FOR THE BLUE TEST PLUG TO REMOVE THE INSPECTION OF 5 NON-CRITICAL DIMENSIONS.  THE BLUE TEST PLUG IS INTENDED FOR USE WITH THE MINILINK TRANSMITTER (MMT-7703) AND IT IS AN ACCESSORY OF PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G SYSTEMS.
P120010|S077|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/09/2015|||OK30|TO MAKE CHANGES IN THE INCOMING INSPECTION CRITERIA FOR THE BLUE TEST PLUG TO REMOVE THE INSPECTION OF 5 NON-CRITICAL DIMENSIONS.  THE BLUE TEST PLUG IS INTENDED FOR USE WITH THE MINILINK TRANSMITTER (MMT-7703) AND IT IS AN ACCESSORY OF PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G SYSTEMS.
P980022|S187|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME INSULIN PUMP;PARADIGM REAL-TIME REVEL INSULIN PUMP|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/08/2015|||OK30|THE APPROVAL OF A MANUFACTURING CHANGE REGARDING THE PREPARATION OF THE PIEZO COMPONENT OF THE ELECTRONIC STACK ASSEMBLIES WITH THE PARADIGM REAL-TIME/REAL-TIME REVEL AND 530G SYSTEM PUMPS; A NEW PREPARATION FIXTURE IS BEING USED TO ASSEMBLE THE PIEZO COMPONENT.  THE AFFECTED INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND MINIMED 530G SYSTEMS.
P120010|S078|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/08/2015|||OK30|THE APPROVAL OF A MANUFACTURING CHANGE REGARDING THE PREPARATION OF THE PIEZO COMPONENT OF THE ELECTRONIC STACK ASSEMBLIES WITH THE PARADIGM REAL-TIME/REAL-TIME REVEL AND 530G SYSTEM PUMPS; A NEW PREPARATION FIXTURE IS BEING USED TO ASSEMBLE THE PIEZO COMPONENT.  THE AFFECTED INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND MINIMED 530G SYSTEMS.
P040037|S087|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS; GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/02/2015|||OK30|TO IMPLEMENT A PROCESS SETTING CHANGE FOR THE RADIO FREQUENCY INDUCTION BONDER MACHINE (RF BONDER).
P130006|S026|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOAVTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/02/2015|||OK30|TO IMPLEMENT A PROCESS SETTING CHANGE FOR THE RADIO FREQUENCY INDUCTION BONDER MACHINE (RF BONDER).
P910001|S081|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY ATHERECTOMY CATHETERS|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/03/2015|||OK30|A MODIFICATION TO THE ETHYLENE OXIDE (EO) STERILIZATION PROCESS.
P960043|S091|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/09/2015|12/31/2015|||APPR|APPROVAL FOR MANUFACTURING SITES LOCATED AT ABBOTT VASCULAR, INC., INTIPPERARY IRELAND AND SYNERGY HEALTH IRELAND LTD., IN OFFALY IRELAND.
P130024|S008|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX 035 DRUG COATED BALLOON PTA CATHETER|ONU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/09/2015|11/24/2015|||APPR|APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO PROVIDE DETAILS REGARDING THE USE OF BARE METAL STENTS WITH THE DEVICE FOR BAILOUT STENTING.
P960040|S360|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN, INOGEN, AND DYNAGEN ICD, INCEPTA, ENERGEN, AND PUNCTUA ICD, TELIGEN ICD|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/2015|12/21/2015|||APPR|APPROVAL FOR HARDWARE MODIFICATIONS TO THE NG3 FAMILY OF DEVICES.
P010012|S405|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ORIGEN, INOGEN, AND DYNAGEN CRT-D, INCEPTA ENERGEN PUNCTUA CRT-D, COGNIS CRT-D|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/09/2015|12/21/2015|||APPR|APPROVAL FOR HARDWARE MODIFICATIONS TO THE NG3 FAMILY OF DEVICES.
P060040|S047|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/09/2015|01/11/2016|||APPR|APPROVAL FOR DESIGN MODIFICATIONS TO THE 14 V LITHIUM-ION BATTERY.
P980044|S029|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2015|12/10/2015|||OK30|SHARING THE FACILITY AND EQUIPMENT USED TO MANUFACTURE SUPARTZ FX FOR THE PURPOSE OF MANUFACTURING OF AN INVESTIGATIONAL DRUG PRODUCT.
P070014|S049|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2015|12/09/2015|||OK30|APPROVAL OF A NEW SUPPLIER FOR A COMPONENT OF YOUR DELIVERY SYSTEM.
P860004|S243|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II IMPLANTABLE INFUSION PUMP|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/10/2015|07/22/2016|||APPR|Approval for a software change to the Model 8870 Application Software Card to reduce the fixed, default Tubing Volume displayed on the priming bolus screen from 0.199 mL to 0.140 mL. This software card is used in the Model 8840 Clinician Programmer to program the Model 8637 SynchroMed II infusion pump. This change is applicable to the full system priming bolus function of the Model 8840 Clinician Programmer to program the Model 8637 SynchroMed II infusion pump. Labeling changes are also being made in the Instructions for Prescribers, Implant Manual and Clinician Programmer Guide to reflect the software change
P980037|S053|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET XMI THROMBECTOMY SET, ANGIOJET SPIROFLEX THROMBECTOMY SET, ANGIOJEET SPIROFLEX VG THROMBECTOMY SET, ANGIOJET DI|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/10/2015|12/11/2015|||APPR|APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION IN MAPLE GROVE, MINNESOTA.
P010019|S042|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON B SOFT CONTACT LENSES O2OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM, AIR OPTIX AQUA MULTIFOCAL.|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2015|12/03/2015|||OK30|TO INTRODUCE AN ALTERNATE SOURCE/MANUFACTURER OF POLYPROPYLENE MOLDED BLISTER SHELLS FOR PACKAGING.
P010030|S070|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/12/2015|02/09/2016|||APPR|Approval for modifications to the Charger/Modem power supply cable.
P030052|S017|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT|NSD|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2015|12/29/2015|||APPR|APPROVAL FOR MANUFACTURING PROCESS CHANGES TO COMPONENTS OF THEPROBECHEK CONTROL SLIDES FOR FISH USING UROVYSION BLADDER CANCER KIT.
P010047|S040|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2015|12/11/2015|||OK30|APPROVAL FOR PHASE 1 OF THE CLEANROOM EXPANSION PLAN AND ALLOW PRODUCT TO BE BUILT AND DISTRIBUTED USING THE EXPANDED CLEANROOM ENVIRONMENT.
P880086|S264|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2015|12/07/2015|||OK30|THE USE OF A MOLD RELEASE AGENT ON HEADER CASTING ASSEMBLIES IN THE ABOVE DEVICES.
P030035|S142|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM,ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2015|12/07/2015|||OK30|THE USE OF A MOLD RELEASE AGENT ON HEADER CASTING ASSEMBLIES IN THE ABOVE DEVICES.
P110016|S026|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) , FLEXABILITY ABLATION CATHETER (UNI-DIRECTIONAL)|LPB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/12/2015|12/11/2015|||APPR|APPROVAL FOR A NEW MANUFACTURING FIXTURE, AND A NEW IN-PROCESS DESTRUCTIVE TEST.
P030016|S029|STAAR SURGICAL CO.|1911 WALKER AVE.||MONROVIA|CA|91016||LENS, INTRAOCULAR, PHAKIC|VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)|MTA|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/12/2015|12/10/2015|||OK30|TO ADD THE GETINGE AUTOCLAVE AS AN ALTERNATE STERILIZER FOR THE VISIAN LENS.
P130008|S009|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE UPPER AIRWAY STIMULATION THERAPY SYSTEM|MNQ|AN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/12/2015|06/02/2016|||APPR|Approval for the Model 2500 Sleep Remote (i.e. patient programmer).
P070026|S032|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2015|12/10/2015|||OK30|CHANGE IN INSPECTION METHOD FROM 100% VISUAL INSPECTION TO 100% INSPECTION WITH A PIN GAUGE AT A CONTRACT MANUFACTURER.
P010012|S406|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|DYNAGEN™ CRT-D Models G150, G151, G154, G156, G158; INOGEN™ CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2015|03/28/2016|||APPR|Approval for a modification to the charge time ratio limit for the high voltage capacitor.
P960040|S361|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|DYNAGEN™ ICD Models D150, D151, D152, D153; INOGEN™ ICD Models D140,|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2015|03/28/2016|||APPR|Approval for a modification to the charge time ratio limit for the high voltage capacitor.
P110042|S056|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/13/2015|12/09/2015|||OK30|TO IMPLEMENT A NEW FIXTURE FOR AN ELECTRICAL TEST AND TO RE-POSITION A VISUAL INSPECTION STEP TO AFTER ELECTRICAL TESTING.
P000037|S044|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE|LWQ|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/13/2015|01/06/2016|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CLARIFICATION ON THE FOLLOW-UP INTERVALS.
P070015|S132|ABBOTT VASCULAR INC.|26531 YNEZ ROAD, BUILDING G|P.O.BOX 9018|TEMECULA|CA|92589|9018|Coronary drug-eluting stent|XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM 13|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2015|04/27/2016|||APPR|Approval for extending the shelf-life of a solvent from 4 months to 12 months.
P990046|S043|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2015|12/16/2015|||OK30|A CHANGE TO THE BIOBURDEN MONITORING STRATEGY AND STERILITY VERIFICATION DOSE MONITORING.
P110010|S117|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|11/16/2015|12/03/2015|||OK30|TO AUTOMATE THE CARTON PACKAGING PROCESS.
P110019|S080|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME,XIENCE XPEDITION, XIENCE ALPINE  EVEROLIMUS ELUTING CORONARY STENT SYSTEMS|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2015|04/27/2016|||APPR|Approval for extending the shelf-life of a solvent from 4 months to 12 months.
P150003|S001|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice||N|11/16/2015|12/03/2015|||OK30|TO AUTOMATE THE CARTON PACKAGING PROCESS.
P040027|S046|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2015|12/15/2015|||OK30|AN ALTERNATE MANUFACTURING LOCATION FOR THE GRAFT COMPONENT AND ALTERNATE LOCATION FOR COMPONENT DESTRUCTIVE TESTING.
P120016|S018|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/16/2015|12/14/2015|||OK30|REMOVAL OF THE COLLAGEN COMPRESSION STEP AND INCOMING INSPECTION COLLAGEN HYDRATION TEST.
P890003|S344|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR|OSR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2015|02/05/2016|||APPR|Approval for the Alert Management Feature for the CareLink Network.
P010031|S522|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD C, S AND XT, VIVA S, VIVA XT CRT-D|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2015|02/05/2016|||APPR|Approval for the Alert Management Feature for the CareLink Network.
P980016|S561|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA S DR,S VR XT DR, XT VE,ICD'S; MAXIMO II ICD,. PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/16/2015|02/05/2016|||APPR|Approval for the Alert Management Feature for the CareLink Network.
P930016|S047|AMO Manufacturing USA, LLC|510 Cottonwood Drive||Milpitas|CA|95035||Excimer laser system|STAR EXCIMER LASER SYSTEM|LZS|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2015|02/09/2016|||APPR|Approval for a back rest replacement switch for the STAR S4 IR Excimer Laser System.
P050028|S048|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2015|02/09/2016|||APPR|Approval to changes in AMPLILINK software v3.4.0.
P980040|S063|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE, TECNIS MULTIFOCAL 1-PIECE IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2015|12/14/2015|||OK30|PERMISSION TO AUTOMATE THEIR MANUFACTURING LINE.
P060030|S049|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2015|02/09/2016|||APPR|Approval to changes in AMPLILINK software v3.4.0.
P110037|S024|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST|PAB|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|11/17/2015|02/09/2016|||APPR|Approval to changes in AMPLILINK software v3.4.0.
P080009|S011|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER- ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|11/18/2015|02/12/2016|||APPR|Approval for software changes to pulse oximeter artifact mitigation period, redundant pulse oximetry signal quality advisory, allotted time for pulse oximeter synchronization (reset and return to normal operation), and the ability to select Clinician Response (manual) mode after starting treatment using automated response mode.
P140012|S003|RESHAPE MEDICAL, INC.|100 CALLE IGLESIA||SAN CLEMENTE|CA|92672||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT|LTI|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|11/18/2015|01/22/2016|||APPR|APPROVAL FOR A DIMENSIONAL CHANGE TO THE TORQUE TRANSMISSION WIRE COMPONENT OF THE RESHAPE REMOVAL CATHETER ASSEMBLY.
P030004|S009|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR|MFE|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/18/2015|12/18/2015|||OK30|THE ADDITION OF CLARIFICATION TO THE COATING PROCEDURE REGARDING THE TOP COAT CURING TIME AND THE INCLUSION OF AN ADDITIONAL WEIGHING BALANCE TO THE COATING PREPARATION PROCEDURE FOR THE APOLLO ONYX DELIVERY MICRO CATHETER.
P100009|S016|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP CLIP DELIVERY SYSTEM|NKM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/18/2015|04/05/2016|||APPR|Approval of the changes to the post-approval study protocol.
P120024|S003|AESCULAP IMPLANT SYSTEMS, LLC|3773 Corporate Parkway||Center Valley|PA|18034||PROSTHESIS, INTERVERTEBRAL DISC|ACTIVL ARTIFICIAL DISC|MJO|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|11/18/2015|12/17/2015|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGES TO THE REPORTING TIMELINE AND ACTIVL® SURGEON SURVEY.
P020025|S081|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP, BLAZER PRIME XP AND INTELLA TIP MIFI XP|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2015|12/17/2015|||OK30|ADDITIONAL SUPPLIER FOR THE STEERING CONTROL WIRE.
P920047|S087|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER PRIME HTD, BLAZER II, BLAZER II HTD|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2015|12/17/2015|||OK30|ADDITIONAL SUPPLIER FOR THE STEERING CONTROL WIRE.
P910071|S016|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||Fluid, intraocular|ADATO SIL-OL 5000 SILICONE OIL|LWL|OP|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2015|01/15/2016|||APPR|APPROVAL FOR SHELF LIFE EXTENSION FOR THE ADATO® SIL-OL 5000 SILICONE OIL.
P050019|S022|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2015|12/17/2015|||OK30|REMOVAL OF TWO DUPLICATE INSPECTIONS DURING FINAL CATHETER MANUFACTURING.
P790005|S053|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2015|12/17/2015|||OK30|QUALIFY AN ALTERNATE SUPPLIER FOR A MATERIAL USED IN THE DEVICE.
P850035|S040|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/19/2015|12/17/2015|||OK30|QUALIFY AN ALTERNATE SUPPLIER FOR A MATERIAL USED IN THE DEVICE.
P950029|S108|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||Pulse generator, permanent, implantable|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR|NVZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2015|05/11/2016|||APPR|Approval for updates to the coating dispensing and curing manufacturing processes for the microelectronic assemblies.
P980049|S114|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101),PARADYM RF VR 9750, PARADYM RF DR 9750(ZL10|MRM|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2015|05/11/2016|||APPR|Approval for updates to the coating dispensing and curing manufacturing processes for the microelectronic assemblies.
P060027|S080|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PARADYM RF CRT-D 9750(ZL102),INTENSIA CRT-D|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2015|05/11/2016|||APPR|Approval for updates to the coating dispensing and curing manufacturing processes for the microelectronic assemblies.
P010047|S041|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|12/17/2015|||OK30|ALTERNATE SUPPLIER OF ANALYTICAL TESTING SERVICES FOR DETERMINATION OF THE TOTAL SODIUM CONTENT IN BICARBONATE BUFFER SOLUTIONS.
P020004|S124|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|12/16/2015|||OK30|TO IMPLEMENT CIRCUMFERENTIAL TENSILE TESTING AS A LOT ACCEPTANCE TEST FOR THE GRAFT COMPONENT.
P040043|S078|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|12/16/2015|||OK30|TO IMPLEMENT CIRCUMFERENTIAL TENSILE TESTING AS A LOT ACCEPTANCE TEST FOR THE GRAFT COMPONENT.
P910073|S133|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE IS-1 AND ENDOTAK RELIANCE 4-SITE LEAD MODELS|LWS|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|04/29/2016|||APPR|Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.
P960004|S075|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II STEROX AND STEROX EZ LEADS|NVN|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|04/29/2016|||APPR|Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.
P010012|S407|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ACUITY SPIRAL LEAD MODELS|OJX|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|04/29/2016|||APPR|Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.
P110016|S027|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|THERAPY COOL PATH DUO,SAFIRE BLU DUO AND COOL PATH DUO,THERAPY COOL PATH DUO SP,SAFIRE BLU DUO SP,THERAY COOL FLEX CATHP|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2015|02/18/2016|||APPR|Approval for software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.
P060019|S035|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP AND THERAPY COOL PATH SP ABLATION CATHETERS, AND 1500T9-CP RF GENERATORS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2015|02/18/2016|||APPR|Approval for software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.
P020025|S082|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER PRIME XP,INTELLATIP MIFI XP, BLAZER II XP TEMPERATURE ABLATION CATHETERS|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|04/28/2016|||APPR|Approval for a vendor change to manufacture the tube braid component, including a resin material change, used on the ablation catheters.
P920047|S088|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER PRIME HTD,BLAZER II,BLAZER II HTD TEMPERATURE ABLATION CATHETERS|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|04/28/2016|||APPR|Approval for a vendor change to manufacture the tube braid component, including a resin material change, used on the ablation catheters.
P100047|S069|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|12/15/2015|||OK30|TO ADD A SUPPLIER FOR A CRITICAL COMPONENT, WHERE THE SPECIFICATIONS ARE UNCHANGED.
P050019|S023|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|12/16/2015|||OK30|MODIFICATIONS TO THE STENT MOUNT PROCESS.
P040014|S028|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2015|02/18/2016|||APPR|Approval of software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.
P040042|S033|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8, THERAPY 8MM THERMISTOR, AND SAFIRE TX ABLATION CATHETERS, AND 1500T6 AND 1500T9 RF GENERATOR|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2015|02/18/2016|||APPR|Approval for software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.
P980006|S025|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|12/16/2015|||OK30|THE IMPLEMENTATION OF AN ALTERNATE RAW MATERIAL SUPPLIER.
P960016|S060|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2015|02/18/2016|||APPR|Approval for software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.
P130026|S012|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|11/20/2015|02/18/2016|||APPR|Approval for software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.
P110023|S016|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/20/2015|12/17/2015|||OK30|AN ALTERNATE SUPPLIER OF WIRE BRAID COMPONENTS FOR YOUR DELIVERY SYSTEM.
P010030|S071|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2015|12/09/2015|||OK30|AN ADDITIONAL, PRE-APPROVED SUPPLIER OF A CUSTOM COMPONENT TO BE USED AS PART OF THE DEVICE IN CONSIDERATION.
P970051|S137|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2015|07/08/2016|||APPR|Approval requested for 1) a change in indications to allow MRI of implant recipients at 1.5T with the implant magnet in place for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST) provided that a Cochlear-supplied MRI kit is used; 2) a change in indications to allow MRI of implant recipients at 3.0T with the implant magnet removed for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST); and 3) consolidation of MRI-related labeling into a single document that provides appropriate instructions for the following Cochlear-manufactured implants: CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), CI24RE(ST), CI24R(CA), CI24R(CS), CI24R(ST), CI24M, and CI 11+11+2M.
P130016|S012|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM|PGQ|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2015|07/08/2016|||APPR|Approval requested for 1) a change in indications to allow MRI of implant recipients at 1.5T with the implant magnet in place for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST) provided that a Cochlear-supplied MRI kit is used; 2) a change in indications to allow MRI of implant recipients at 3.0T with the implant magnet removed for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST); and 3) consolidation of MRI-related labeling into a single document that provides appropriate instructions for the following Cochlear-manufactured implants: CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), CI24RE(ST), CI24R(CA), CI24R(CS), CI24R(ST), CI24M, and CI 11+11+2M.
P840001|S318|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME,SPECIFY, & VECTRIS CORD STIMULATION LEADS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2015|12/23/2015|||OK30|UPDATE OF THE PULL TEST SAMPLE SIZE AND CONTROL LIMITS USED FOR SPECIAL MANUFACTURING PROCESS MONITORING IN ALIGNMENT WITH THE STATISTICAL PROCESS CONTROL PROGRAM AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN VILLALBA, PUERTO RICO.
P960009|S242|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2015|12/23/2015|||OK30|UPDATE OF THE PULL TEST SAMPLE SIZE AND CONTROL LIMITS USED FOR SPECIAL MANUFACTURING PROCESS MONITORING IN ALIGNMENT WITH THE STATISTICAL PROCESS CONTROL PROGRAM AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN VILLALBA, PUERTO RICO.
P970004|S208|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2015|12/23/2015|||OK30|UPDATE OF THE PULL TEST SAMPLE SIZE AND CONTROL LIMITS USED FOR SPECIAL MANUFACTURING PROCESS MONITORING IN ALIGNMENT WITH THE STATISTICAL PROCESS CONTROL PROGRAM AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN VILLALBA, PUERTO RICO.
P130009|S042|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|ASCENDRA+ DELIVERY SYSTEM, NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET CRIMPER, QUALCRIMP CRIMPI|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2015|12/11/2015|||OK30|ADDITION OF A NEW CLEANROOM TO THE EDWARDS DRAPER, UT FACILITY.
P080025|S103|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2015|12/23/2015|||OK30|UPDATE OF THE PULL TEST SAMPLE SIZE AND CONTROL LIMITS USED FOR SPECIAL MANUFACTURING PROCESS MONITORING IN ALIGNMENT WITH THE STATISTICAL PROCESS CONTROL PROGRAM AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN VILLALBA, PUERTO RICO.
P140011|S001|SIEMENS MEDICAL SOLUTIONS USA, INC.|51 VALLEY STREAM PKWY.||MALVERN|PA|19355|1406|Digital breast tomosynthesis|MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION|OTE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2015|05/12/2016|||APPR|Approval for change to the indications for use statement.  The device, as modified, will be marketed under the trade name MAMMOMAT Inspiration with Tomosynthesis Option and is indicated for acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer.  A screening examination may consist of a 3D DBT image set and/or a 2D FFDM image set.
P060001|S024|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, ILIAC|PROTEGE GPS STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/23/2015|12/14/2015|||OK30|A CHANGE TO YOUR MANUFACTURING EQUIPMENT FOR THE PROTEGE GPS STENT SYSTEM.
P130022|S004|NEVRO CORPORATION|1800 BRIDGE PARKWAY||REDWOOD CITY|CA|94065||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SENZA SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/23/2015|04/15/2016|||APPR|Approval for the Surgical Lead Models LEAD3005-xx, LEAD3015-xx, and LEAD3025-xx.
P970003|S188|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|PULSE/PULSE DUO GENERATOR-MODEL 102/102R|MUZ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|11/24/2015|02/19/2016|||APPR|Approval for labeling changes being made to the Model 102/102R Technical Information Chapter of the VNS Therapy Physician’s Manual involving the addition/correction of information concerning generator performance exceptions.
P100047|S070|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2015|02/09/2016|||APPR|Approval for process changes at the internal battery supplier for HVAD controller.
P030022|S034|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIPS SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2015|12/17/2015|||OK30|ADDITION OF A NEW WATER GENERATOR.
P900033|S054|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||DEVICE, DERMAL REPLACEMENT|INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED|MDD|SU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2015|05/03/2016|||APPR|Approval for a manufacturing site located at Integra LifeSciences Corporation, 109 Morgan Lane, Plainsboro, New Jersey, as a new and alternate manufacturing facility.
P120005|S042|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/2015|02/05/2016|||APPR|Approval for modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of the G4 PLATINUM/G5 Mobile sensor component which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The proposed change occurs at Tech Group, Dexcom’s approved supplier. The sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.
P990046|S044|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE,OPEN PIVOT AORTIC VALVED GRAFT,OPEN PIVOT HEART VALVE-APEX,OPEN PIVOT HEART VALVE-AP360|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2015|12/16/2015|||OK30|TO RELOCATE YOUR FABRIC VENDOR'S MANUFACTURING OPERATIONS TO LA COITAT, FRANCE.
P120020|S012|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/24/2015|12/16/2015|||OK30|MODIFICATIONS TO THE WELDING PROCESS FOR THE SUPERA PERIPHERAL STENT SYSTEM.
P140010|S013|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|11/24/2015|07/06/2016|||APPR|Approval for a 150 mm balloon length.
P830055|S165|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice||N|11/25/2015|12/23/2015|||OK30|CHANGE FROM A MANUAL TO AN AUTOMATED INSPECTION METHOD AND TO INCREASE THE FREQUENCY OF THIS INSPECTION FOLLOWING THE MACHINE MILLING OF A SLOT IN THE LCS COMPLETE MODULAR REVISION FEMORAL COMPONENTS MANUFACTURED AT THE DEPUY INTERNATIONAL, LTD., FACILITY IN LEEDS, UNITED KINGDOM.
P880086|S265|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKERS DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2015|12/15/2015|||OK30|AN ALTERNATE SUPPLIER FOR THE B CONNECTOR (IS-1 CONNECTOR.
P030035|S143|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ANTHEM, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2015|12/15/2015|||OK30|AN ALTERNATE SUPPLIER FOR THE B CONNECTOR (IS-1 CONNECTOR.
P910023|S366|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2015|12/15/2015|||OK30|AN ALTERNATE SUPPLIER FOR THE B CONNECTOR (IS-1 CONNECTOR.
P030054|S296|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2015|12/15/2015|||OK30|AN ALTERNATE SUPPLIER FOR THE B CONNECTOR (IS-1 CONNECTOR.
P140020|S004|MYRIAD GENETIC LABORATORIES|320 Wakara Way||Salt Lake City|UT|84108||Cancer-related germline gene mutation detection system|BRACANALYSIS CDX|PJG|PA|30-Day Notice||N|11/25/2015|12/22/2015|||OK30|CHANGES TO THE LABORATORY SPACE LAYOUT.
P040045|S053|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2015|12/10/2015|||OK30|IMPLEMENTATION OF AN ALTERNATE RAW MATERIAL PROCESS FOR A SENOFILCON A MONOMER COMPONENTS OF VISTAKON (SENOFILCON A) BRAND CONTACT LENSES.
P110007|S007|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE)|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/2015|12/22/2015|||APPR|APPROVAL FOR CHANGES MADE TO THE DIRECTIONS FOR USE (DFU) TO CLARIFY INSTRUCTIONS FOR USE OF THE FINGER GRIP.
P810031|S055|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV, HEALON5 PRODUCTS, HEALON ULTIMATE DUAL PACK, AND H|LZP|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/25/2015|12/22/2015|||APPR|APPROVAL FOR CHANGES MADE TO THE DIRECTIONS FOR USE (DFU).
P910001|S082|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL)|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2015|12/18/2015|||OK30|CHANGE TO THE PROXIMAL MARKER BAND FUSING PROCESS.
P110016|S028|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|Cardiac ablation percutaneous catheter|FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) ; FLEXABILITY ABLATION CATHETER(UNI-DIRECTIONAL)|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/25/2015|12/21/2015|||OK30|AN ALTERNATE DEFLECTION TESTER FOR FINAL RELEASE TESTING.
P980037|S054|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET  RHEOLYTIC THROMBECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2015|12/18/2015|||OK30|CHANGE TO THE SUB-ASSEMBLY MANUFACTURING PROCESS.
P130028|S001|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2015|12/18/2015|||OK30|CHANGE IN SUPPLIER FOR THE LCD MODULE COMPONENT THAT PROVIDES THE PPC TOUCHSCREEN INTERFACE.
P030017|S243|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2015|12/18/2015|||OK30|CHANGE IN SUPPLIER FOR THE 47 ÌH AND 100 ÌH INDUCTORS.
P980022|S189|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2015|12/23/2015|||OK30|TRANSFER OF TWO SUB-ASSEMBLY PROCESSES FOR THE PARADIGMREAL? TIME, PARADIGM REAL? TIME REVEL, AND MINIMED 530G INSULIN PUMPS FROM MEDTRONIC MINIMED IN NORTHRIDGE, CA TO MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM REAL ]TIME AND REAL? TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGMREAL?]TIME AND REAL? TIME REVEL SYSTEMS, RESPECTIVELY. THE MINIMED 530G INSULIN PUMP IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P120010|S080|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/27/2015|12/23/2015|||OK30|TRANSFER OF TWO SUB-ASSEMBLY PROCESSES FOR THE PARADIGMREAL? TIME, PARADIGM REAL? TIME REVEL, AND MINIMED 530G INSULIN PUMPS FROM MEDTRONIC MINIMED IN NORTHRIDGE, CA TO MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM REAL ]TIME AND REAL? TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGMREAL?]TIME AND REAL? TIME REVEL SYSTEMS, RESPECTIVELY. THE MINIMED 530G INSULIN PUMP IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P000025|S083|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR IMPLANT SYSTEM)|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/30/2015|12/29/2015|||OK30|ALTERNATIVES TO BATCH TESTING FOR BACTERIAL ENDOTOXINS AND ESTABLISHMENT OF A DYNAMIC SAMPLING PLAN.
P050037|S064|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2015|12/29/2015|||OK30|FOUR CHANGES IN THE MANUFACTURING PROCESS OF THE CALCIUM HYDROXYLAPATITE (CAHA) PARTICLES IN RADIESSE.
P050052|S075|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE (+) LIDOCAINE DERMAL FILLER|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2015|12/29/2015|||OK30|FOUR CHANGES IN THE MANUFACTURING PROCESS OF THE CALCIUM HYDROXYLAPATITE (CAHA) PARTICLES IN RADIESSE.
P150003|S002|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS ELUTING PLATINUM CHROMIUN CORONARY STENT SYSTEM MONORAIL & OVER THE WIRE.|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2015|04/07/2016|||APPR|Approval for a manufacturing site located at Boston Scientific Maple Grove, One/Two Scimed Place, Maple Grove, Minnesota for stent finishing (electropolishing, passive inspection , and final clean).
P140012|S004|RESHAPE MEDICAL, INC.|100 CALLE IGLESIA||SAN CLEMENTE|CA|92672||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2015|12/31/2015|||OK30|ADDITION OF VESTA, INC., AS A SECOND SOURCE SUPPLIER OF THE BALLOON SHELL (P/N 03-0238).
P070026|S033|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM.|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2015|12/15/2015|||OK30|CHANGE TO A NEW DOSIMETRY SYSTEM AT STERIS ISOMEDIX SERVICES (LIBERTYVILLE, OHIO).
P830055|S166|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2015|12/15/2015|||OK30|CHANGE TO A NEW DOSIMETRY SYSTEM AT STERIS ISOMEDIX SERVICES (LIBERTYVILLE, OHIO).
P890003|S345|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC MODEL 31301 CARELINK EXPRESS APP.|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/2015|05/03/2016|||APPR|Approval for the Model 31301 CareLink Express App.
P830061|S123|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, VITATRON CRYSTALLINE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/01/2015|12/08/2015|||OK30|A SUPPLIER CHANGE FOR A COUPLER COMPONENT.
P980016|S562|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD, S DR ICD, S VR ICD, XT DR ICD, ST VR ICF, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECT ICD, S|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/2015|05/03/2016|||APPR|Approval for the Model 31301 CareLink Express App.
P980035|S447|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG. ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA  SR MRI IPG, ENOUKSE E2 IOG, KAPPA D IPG,KAPPA DR IP|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/2015|05/03/2016|||APPR|Approval for the Model 31301 CareLink Express App.
P010015|S287|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/2015|05/03/2016|||APPR|Approval for the Model 31301 CareLink Express App.
P010031|S523|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D; MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/2015|05/03/2016|||APPR|Approval for the Model 31301 CareLink Express App.
P090013|S209|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENO MRI SURESCAN IPG|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/01/2015|05/03/2016|||APPR|Approval for the Model 31301 CareLink Express App.
P050037|S065|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2015|05/31/2016|||APPR|Approval for the following three changes: 1) Qualification testing of the BI spore strips, 2) Bioburden test frequency, and 3) Endotoxin detection limit.
P050052|S076|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE LOW VISCOSITY INJECTABLE IMPLANT; RADIESSE (+) LIDOCAINE DERMANL FILTER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/02/2015|05/31/2016|||APPR|Approval for the following three changes: 1) Qualification testing of the BI spore strips, 2) Bioburden test frequency, and 3) Endotoxin detection limit.
P140019|S001|CERAPEDICS, LLC|11025 DOVER STREET|SUITE 1600|WESTMINSTER|CO|80021||Filler, bone void, synthetic peptide|I-FACTOR PEPTIDE ENHANCED BONE GRAFT|NOX|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|12/03/2015|03/17/2016|||APPR|Approval of the protocol for the ODE Lead PMA Post-Approval Study.
P090013|S210|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|12/16/2015|||OK30|A CHANGE IN ENVIRONMENTAL MONITORING FROM MANUAL READINGS TO AN AUTOMATED SOFTWARE SYSTEM.
P830061|S124|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|12/16/2015|||OK30|A CHANGE IN ENVIRONMENTAL MONITORING FROM MANUAL READINGS TO AN AUTOMATED SOFTWARE SYSTEM.
P930039|S144|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX NOVUS LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|12/16/2015|||OK30|A CHANGE IN ENVIRONMENTAL MONITORING FROM MANUAL READINGS TO AN AUTOMATED SOFTWARE SYSTEM.
P980035|S448|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|12/16/2015|||OK30|A CHANGE IN ENVIRONMENTAL MONITORING FROM MANUAL READINGS TO AN AUTOMATED SOFTWARE SYSTEM.
P040033|S029|SMITH&NEPHEW ORTHOPAEDICS|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/metal, resurfacing|BIRMINGHAM HIP RESURFACING (BHR) SYSTEM|NXT|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/28/2016|||OK30|LOCATION CHANGE OF A PACKAGE SUPPLIER.
P030022|S035|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/28/2016|||OK30|LOCATION CHANGE OF A PACKAGE SUPPLIER.
P130017|S005|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|12/23/2015|||OK30|CHANGE THE FOLLOWING: USE OF SOFTWARE SPREADSHEET WORKBOOK FOR AUTOMATED DATA PROCESSING IN PLACE OF MANUAL CALCULATIONS OF ACCEPTANCE CRITERIA FOR QUALITYCONTROL (QC) TEST; REVISION OF THE UPPER SPECIFICATION LIMIT FOR QC BLANK POSITIVITY FOR MARKERSBTACT AND ACT; RELOCATION OF THE QC LABORATORIES FROM THE FIRST FLOOR TO THE SECOND FLOORWITHIN THE SAME FACILITY; AND RELOCATION OF THE LABELING AND DISPENSING ACTIVITIES INTO OTHER ROOMSON THE SAME FLOOR.
P970051|S138|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|12/30/2015|||OK30|APPROVAL FOR A CHANGE TO THE PRE-STERILIZATION CLEANING PROCESS TO ALLOW FOR ADDITIONAL DEVICES TO BE CLEANED PRIOR TO THE STERILIZATION CYCLE
P130016|S013|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|12/30/2015|||OK30|APPROVAL FOR A CHANGE TO THE PRE-STERILIZATION CLEANING PROCESS TO ALLOW FOR ADDITIONAL DEVICES TO BE CLEANED PRIOR TO THE STERILIZATION CYCLE.
P050037|S066|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|06/03/2016|||APPR|Approval for changes to CaHA particle lot size and extrusion force testing.
P050052|S077|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, RADIESSE(+)|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/04/2015|06/03/2016|||APPR|Approval for changes to CaHA particle lot size and extrusion force testing.
P050037|S067|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/07/2015|02/22/2016|||APPR|Approval for replacing the 28 GA needle with a 27 GA needle in RADIESSE and RADIESSE (+) Lidocaine Kits, and revision to the labeling to reflect the approved 36 month expiration date for 1.5 cc fill volume.
P050052|S078|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE,RADIESSE (+) LIDOCAINE DERMAL FILLER|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|12/07/2015|02/22/2016|||APPR|Approval for replacing the 28 GA needle with a 27 GA needle in RADIESSE and RADIESSE (+) Lidocaine Kits, and revision to the labeling to reflect the approved 36 month expiration date for 1.5 cc fill volume.
P930014|S087|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|12/31/2015|||OK30|ALCON LABORATORIES IRELAND LTD. AS AN ALTERNATE INTRAOCULAR LENS MANUFACTURING FACILITY FOR ACRYSOF IQ TORIC IOL (MODELS SN6AT6, SN6AT7, SN6AT8, SN6AT9) AND THE USE OF THE MANUAL WET NIMO EQUIPMENT FOR THE SPHERICAL ABERRATION MEASUREMENT MANUFACTURING PROCESS STEP IN PLACE OF THE CURRENT LONG WET MANUAL ABERROMETER SYSTEM SPECIFICALLY FOR LOW DIOPTER (6.0 ¿ 9.5 DIOPTER) IQ TORIC LENSES.
P050037|S068|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE, RADIESSE LOW VISCOSITY|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|06/03/2016|||APPR|Approval for three changes to the calcium hydroxylapatite particle manufacturing process and one change to the sodium carboxymethylcellulose sampling process.
P050052|S079|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE LOW VISCOSITY, RADIESSE (+)|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|06/03/2016|||APPR|Approval for three changes to the calcium hydroxylapatite particle manufacturing process and one change to the sodium carboxymethylcellulose sampling process.
P000021|S028|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|DIMENSION VISTA TPSA ASSAY|MTF|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/2015|10/19/2016|||APPR|Approval for a device modification to add a new photomultiplier tube (PMT) to the Dimension Vista 1500 and 500 Systems.
P130009|S043|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|NOVAFLEX+ DELIVERY SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|12/21/2015|||OK30|A CHANGE TO MEASURING EQUIPMENT USED IN THE RECEIVING INSPECTION OF THE FLEX TIP OF THE NOVAFLEX DELIVERY SYSTEM.
P150003|S003|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL)|NIQ|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|12/07/2015|07/29/2016|16M-2334|08/18/2016|APPR|Approval for the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire).  This device is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >=2.25 mm to <=4.00 mm in diameter in lesions <=34 mm in length.
P130011|S002|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|SOLO SMART STENTLESS HEART VALVE (SOLO SMART)|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|02/09/2016|||APPR|Approval for a change to the sterility testing of the final storage solution.
P880086|S266|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY, ASSURITY+, ENDURITY, ENDURITY CORE FAMILY OF PACEMAKER DEVICES|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|01/04/2016|||OK30|ALTERNATIVE SUPPLIER FOR THE TELEMETRY COIL COMPONENT OF THE HYBRID ASSEMBLIES.
P030035|S144|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|01/04/2016|||OK30|ALTERNATIVE SUPPLIER FOR THE TELEMETRY COIL COMPONENT OF THE HYBRID ASSEMBLIES.
P130026|S013|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH  QUARTZ SET|OAE|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|12/22/2015|||APPR|APPROVAL FOR ADDITIONAL SLIDER RACE COMPONENT MANUFACTURING FIXTURES.
P020027|S023|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION VISTA FPSA ASSAY|MTG|IM|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/07/2015|10/19/2016|||APPR|Approval for a device modification to add a new photomultiplier tube (PMT) to the Dimension Vista 1500 and 500 Systems.
P040044|S068|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F)|MGB|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/07/2015|09/06/2016|||APPR|Approval for a manufacturing site located at 9020 Activity Road, Suite D, San Diego, California, 92126 for the sterilization of the Mynx Grip Vascular Closure Device (5F/6F/7F) and Mynx Ace Vascular Closure Device (5F/6F/7F).
P010032|S108|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EXTERNAL PULSE GENERATOR, 16 CHANNEL, EXTERNAL PULSE GENERATOR, 2 PORT HEADER|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/08/2015|03/07/2016|||APPR|Approval for changes to the packaging configuration of the External Pulse Generator, 2Port Header (Model3032) used with the External Pulse Generator (Model3599) approved under P010032/S092. Specifically, you propose to remove a component, the magnet, from the EPG header kit (model 3032) to allow for separate distribution. In addition, also requested updates to the EPG Clinician’s manual and the MLTC Clinician’s manual.
P870076|S018|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM|KNH|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2015|03/22/2016|||APPR|Approval for a manufacturing site located at 9600 Louisiana Avenue North, Brooklyn Park, MN 55445 for the production of the Falope Ring Band.
P040027|S047|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/08/2015|01/07/2016|||OK30|REQUESTED AN ALTERNATE PTFE RESIN USED TO MANUFACTURE THE REINFORCING FILM COMPONENT.
P100049|S015|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/08/2015|03/02/2016|||APPR|Approval for updating the labeling with safety and effectiveness data out to five (5) years for the pivotal trial cohort extended follow-up that has been completed and modify the Indications For Use.
P930014|S088|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|01/06/2016|||OK30|REQUESTED PARAMETRIC RELEASE FOR THE ALCON HUNTINGTON AODC NORTH (AODC-N) ETHYLENE OXIDE STERILIZATION PROCESS.
P040020|S059|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|01/06/2016|||OK30|REQUESTED PARAMETRIC RELEASE FOR THE ALCON HUNTINGTON AODC NORTH (AODC-N) ETHYLENE OXIDE STERILIZATION PROCESS.
P880087|S023|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|01/06/2016|||OK30|REQUESTED PARAMETRIC RELEASE FOR THE ALCON HUNTINGTON AODC NORTH (AODC-N) ETHYLENE OXIDE STERILIZATION PROCESS.
P810032|S064|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|01/06/2016|||OK30|REQUESTED PARAMETRIC RELEASE FOR THE ALCON HUNTINGTON AODC NORTH (AODC-N) ETHYLENE OXIDE STERILIZATION PROCESS.
P840060|S041|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|01/06/2016|||OK30|REQUESTED PARAMETRIC RELEASE FOR THE ALCON HUNTINGTON AODC NORTH (AODC-N) ETHYLENE OXIDE STERILIZATION PROCESS.
P040043|S079|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|01/08/2016|||OK30|CHANGE IN THE MANUFACTURING PROCESSES OF THE GRAFT BASE TUBE COMPONENT.
P050038|S028|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/FLEXITIP XL-R|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|01/07/2016|||OK30|REQUESTED CHANGES IN THE SUPPLIER OF THE ARISTA AH FLEXITIP XL-R STAINLESS STEEL COMPONENT.
P050039|S018|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS)|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|12/30/2015|||OK30|ADDITION OF CERAMTECH'S MARKTREDWITZ FACILITY FOR THE USE OF THE HOT ISOSTATIC PRESSURE (HIP) PROCESS.
P980044|S030|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/09/2015|01/06/2016|||OK30|REQUESTED MODIFICATIONS TO EXISTING CLEANROOMS IN THE SUPARTZ FX MANUFACTURING FACILITY.
P990081|S034|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||SYSTEM, TEST, HER-2/NEU, IHC|PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY|MVC|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2015|04/13/2016|||APPR|Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.
P100027|S024|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2015|04/13/2016|||APPR|Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.
P020055|S018|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Immunohistochemistry antibody assay, c-kit|VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)|NKF|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2015|04/13/2016|||APPR|Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.
P140025|S002|VENTANA MEDICAL SYSTEMS, INC.|1910 EAST INNOVATION PARK DR.||TUCSON|AZ|85755||Immunohistochemistry assay, antibody, anaplastic lymphoma kinase|VENTANA ALK (D5F3) CDX ASSAY|PKW|PA|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2015|04/13/2016|||APPR|Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.
P030027|S008|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002|0000|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2015|12/30/2015|||OK30|ADDITION OF CERAMTECH'S MARKTREDWITZ FACILITY FOR THE USE OF THE HOT ISOSTATIC PRESSURE (HIP) PROCESS.
P950034|S044|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/10/2015|01/07/2016|||OK30|ADDITIONAL SUPPLIER OF POLY(METHYL METHACRYLATE) (PMMA), PLASKOLITE, TO BE QUALIFIED FOR USE IN THE MANUFACTURE OF THE CASTING SHEETS PRODUCED BY AIN PLASTICS. THE CASTING SHEETS ARE IN TURN USED IN THE MANUFACTURE OF THE DEVICE (SEPRAFILM).
P050037|S069|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2015|04/12/2016|||APPR|Approval for changes in the manufacturers of chemicals used in the Radiesse manufacturing process.
P050052|S080|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE (+) LIDOCAINE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2015|04/12/2016|||APPR|Approval for changes in the manufacturers of chemicals used in the Radiesse manufacturing process.
P050052|S081|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/11/2015|01/20/2016|||APPR|APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:REVISIONS TO THE PATIENT DIARY, ENROLLMENT FORM AND RADIOLOGY FORM.
P990075|S035|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|SPECTRUM BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2015|01/07/2016|||OK30|CHANGE TO THE SUPPLIER FOR THE FILL TUBE; A COMPONENT OF THE MENTOR SPECTRUM BREAST IMPLANTS.
P060040|S048|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS), THORATEC VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2015|02/22/2016|||APPR|Approval for a change in the supplier facility location for the Emergency Backup Battery and Sealed Lead Acid Battery.
P020045|S069|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CATHETER|LPB|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2015|12/31/2015|||APPR|APPROVAL FOR AN ADDITIONAL 20X MAGNIFICATION INSPECTION OF THE CATHETERS¿ SHAFTS.
P030011|S037|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2015|01/07/2016|||OK30|CHANGE IN THE ASSEMBLER AND REPLACEMENT OF COMPONENTS FOR THE FREEDOM DRIVER MAIN PRINTED CIRCUIT BOARD ASSEMBLY.
P010032|S109|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PROTEGE,PRODIGY,PROCLAIM ELITE FAMILY OF SCS IPGS AND SCS EPG|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2015|10/03/2016|||APPR|Approval for the Clinician Programmer App (Version 3.2) Model 3874, Programmer App (Version 3.2) Model 3875, and the Protégé/Prodigy/Proclaim Elite family of SCS IPGs and SCS EPG which includes the following components:1) IPGs:  Protégé (Models 3789), Prodigy (Model 3799), Protégé MRI (Model 377l), Prodigy MRI (Model 3772), and Proclaim 5 Elite (Model 3660);  2) Proclaim 7 Elite (Model 3662) SCS EPG Model 3599; 3) Patient Programmer Models 3855 and 3856; 4) Rapid Programmer Model 3834 (Version 3.7); 5) Clinician Programmer App Model 3874 (Version 3.2); and 6) Patient Controller App Model 3875 (Version 3.2).
P140009|S010|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|INFINITY FAMILY OF DBS IPGS AND DBS EPG|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/11/2015|10/03/2016|||APPR|Approval for the Clinician Programmer App (Version 3.2) Model 3874, Programmer App (Version 3.2) Model 3875 (P140009), and the Protégé/Prodigy/Proclaim Elite family of SCS IPGs and SCS EPG  (P010032) which includes the following components:1) IPGs:  Protégé (Models 3789), Prodigy (Model 3799), Protégé MRI (Model 377l), Prodigy MRI (Model 3772), and Proclaim 5 Elite (Model 3660); 2) Proclaim 7 Elite (Model 3662) SCS EPG Model 3599; 3) Patient Programmer Models 3855 and 3856; 4) Rapid Programmer Model 3834 (Version 3.7); 5) Clinician Programmer App Model 3874 (Version 3.2); and 6) Patient Controller App Model 3875 (Version 3.2).
P860004|S244|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/11/2015|01/08/2016|||OK30|CHANGE TO THE INCOMING INSPECTION METHODS FOR COIL INSULATION AND COIL RESISTANCE FOR THE MOTOR USED IN THE SYNCHROMED® II PUMP.
P970029|S028|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TMR SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/11/2015|12/22/2015|||APPR|APPROVAL OF UPDATES REGARDING FOREIGN MATERIAL INSPECTIONS, AND LEAK TESTING.
P960009|S243|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/14/2015|02/29/2016|||APPR|Approval for the addition of new/updated safety information, specifically a warning for status dystonicus (for dystonia labeling) and potential adverse events, and the consolidation of therapy-wide adverse events supplemented by indication-specific labeling addenda.
P130009|S044|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/14/2015|01/08/2016|||OK30|MODIFY THE RECEIVING VISUAL INSPECTION CRITERIA FOR THE POLYPROPYLENE TUBING USED FOR PACKAGING OF THE NOVAFLEX+ DELIVERY SYSTEM AND EDWARDS EXPANDABLE INTRODUCER SHEATH SET.
P120005|S043|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINIOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2015|01/14/2016|||OK30|ADDITION OF A CONTRACT STERILIZER FOR THE G5 MOBILE/G4 PLATINUM SENSOR.  THE G5 MOBILE/G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM AND THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM.
P120010|S081|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ENLITE GLUCOSE SENSOR|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2015|01/14/2016|||OK30|ADDING AN ALTERNATE ENLITE SENSOR AUTOMATED HYBRID MANUFACTURING LINE (ENLITE AUTOMATION HYBRID LINE).  THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
P030002|S036|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|TRULIGN TORIC WEB BASED TORIC CALCULATOR|MJP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/15/2015|02/17/2016|||APPR|Approval for software changes to the web-based toric calculator (WBTC) used with the Trulign Toric IOL.
P950022|S090|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|OPTISURE FAMILY OF HIGH VOLTAGE LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2015|01/08/2016|||OK30|IMPLEMENTATION OF UPDATED PRIMER APPLICATION INSTRUCTIONS AND UPDATES TO MANUFACTURING TOOL AIDS.
P950034|S045|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2015|01/14/2016|||OK30|AN EXTENSION OF THE POST-DHT DRY HEAT TREATMENT MAXIMUM HOLD TIME FOR YOUR SEPRAFILM ADHESION BARRIER DEVICE.
P080030|S018|GLAUKOS, CORPORATION|26051 MERIT CIRCLE, SUITE 103||LAGUNA HILLS|CA|92653||Intraocular pressure lowering implant|GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM|OGO|OP|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/15/2015|09/30/2016|||APPR|Approvable Pending Inspection
P980035|S449|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA,  VERSA, SENSIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2015|01/05/2016|||OK30|THE REMOVAL OF A SWAB TEST FOR THE ABOVE REFERENCED DEVICE.
P120012|S010|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II|OBF|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2015|03/07/2016|||APPR|Approval for revisions to the application specification file for changes to the liquid level sense and pipette aspiration/dispense volumes during the sample preparation extraction process.
P050023|S093|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IFORIA 5/7 DR-T/VR-T/VR-T DX; INVENTRA 7 DR-T/VR-T/VR-T DX; IPERIA 5/7 DR-T/VR-T/VR-T DX; LUMAX 300/340 DR/DR-T/VR/VR-T|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2015|04/13/2016|||APPR|Approval for the PSW 1506.U Programmer Software.
P070008|S069|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV/LV-T, EVIA HF/HF-T; ENTOVIS HF/HF-T|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2015|04/13/2016|||APPR|Approval for the PSW 1506.U Programmer Software.
P140031|S004|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (26MM SIZE ONLY)|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/16/2015|01/04/2016|||OK30|ADD A NEW LASER FOR THE PRODUCTION OF THE 26 MM SAPIEN 3 TRANSCATHETER HEART VALVE FRAMES.
P100026|S040|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/16/2015|03/15/2016|||APPR|Approval of an alternate supplier to manufacture a lead coil assembly, and resultant minor specification tolerance and testing changes.
P000009|S064|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BELOS DR/DR-T/VR-VR-T LEXOS DR/DR-T/VR-VR-T; LUMOS DR-T/VR-T; XELOS DR-T|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2015|04/13/2016|||APPR|Approval for the PSW 1506.U Programmer Software.
P950037|S160|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|ACROS DR/SR/SLR/D/S,AXIOS  DR/SR/SLR/D/S,BA03 DDDR,CYLOS DR/DR-T/VR,DROMOS DR/SR/SL,KAIROS DR/SR/SL/D/S,PHILOS DR/DR-T/S|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/16/2015|04/13/2016|||APPR|Approval for the PSW 1506.U Programmer Software.
P810031|S056|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705|||HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI||OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/2015|06/14/2016|||APPR|Approval for an alternative secondary blister tray packaging configuration called drop pack for AMOs family of Healon® OVDs that incorporates a transition Tyvek® lid manufactured using DuPonts flash-spinning process.
P100020|S017|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS|MAQ|MI|Panel Track|Change Design/Components/Specifications/Material|N|12/23/2015|07/07/2016|16M-1917|07/19/2016|APPR|Approval for the cobas® HPV Test.  The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the ThinPrep® Pap TestTM PreservCyt® Solution or using a cervical broom and placed in SurePath Preservative Fluid.  The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis.  The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).The cobas® HPV Test is indicated:1) To screen patients 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy; 2) To be used in patients 21 years and older with ASC-US cervical cytology results, to detect high-risk HPV genotypes 16 and 18.  This information, together with the physicians assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management.  The results of this test are not intended to prevent women from proceeding to colposcopy; 3) In women 30 years and older, the cobas® HPV Test can be used with cervical cytology to adjunctively screen to detect high risk HPV types.  This information, together with the physician’s assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management; 4) In women 30 years and older, the cobas® HPV Test can be used to detect HPV genotypes 16 and 18.  This information, together with the physicians assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management; and 5) In women 25 years and older, the cobas® HPV Test can be used for specimens collected only in ThinPrep® Pap TestTM PreservCyt® Solution as a first-line primary cervical cancer screening test to detect high risk HPV, including genotyping for 16 and 18. Women who test negative for high risk HPV types by the cobas® HPV Test should be followed up in accordance with the physicians assessment of screening and medical history, other risk factors, and professional guidelines. Women who test positive for HPV genotypes 16 and/or 18 by the cobas® HPV Test should be referred to colposcopy. Women who test high risk HPV positive and 16/18 negative by the cobas® HPV Test (12 other HR HPV positive) should be evaluated by cervical cytology to determine the need for referral to colposcopy.
P060037|S043|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM|NJL|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|12/17/2015|01/15/2016|||APPR|APPROVAL FOR THE ADDITION OF WARNINGS REGARDING USE OF THE DEVICE IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT.
P120005|S044|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2015|01/13/2016|||OK30|TO ADD AN ADDITIONAL CONTRACT LABORATORY FOR PERFORMING BIOBURDEN AND STERILITY TESTING, WHICH IS USED TO SUPPORT OF STERILIZATION VALIDATION OF THE G5 MOBILE/G4 PLATINUM SENSOR.  THE G5 MOBILE/G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4 PLATINUM AND THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMS.
P080009|S012|ETHICON ENDO-SURGERY, INC.|4545 CREEK RD.|MAIL LOCATION 110|CINCINNATI|OH|45242|2839|Computer-assisted personalized sedation system|SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM|PDR|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|12/17/2015|03/15/2016|||APPR|Approval for software changes to address previous software anomalies (modifications to the Bedside Monitoring Unit (BMU) software to address wireless driver-caused shutdowns, BMU software modifications to address noninvasive blood pressure (NIBP) measurements).
P020045|S070|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/12/2016|||OK30|ACCEPTANCE FOR A MODIFICATION TO A SUPPLIER'S MANUFACTURING EQUIPMENT.
P100010|S052|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYOBLATION CATHETERS|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/12/2016|||OK30|ACCEPTANCE FOR A MODIFICATION TO A SUPPLIER'S MANUFACTURING EQUIPMENT.
P970051|S139|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2015|01/15/2016|||OK30|ADDITION OF AN AUTOMATED MICROBLAST DEFLASHING OF THE FEEDTHROUGH FOR THE CI500 SERIES COCHLEAR IMPLANTS.
P790005|S054|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2015|01/14/2016|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER TO PROVIDE ISOPROPYL ALCOHOL.
P850035|S041|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|SPF IMPLANTABLE SPINAL FUSION STIMULATORS|LOE|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2015|01/14/2016|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER TO PROVIDE ISOPROPYL ALCOHOL.
P790002|S034|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET EBI BONE HEALING SYSTEM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2015|01/14/2016|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER TO PROVIDE ISOPROPYL ALCOHOL.
P850022|S027|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/17/2015|01/14/2016|||OK30|QUALIFICATION OF AN ALTERNATE SUPPLIER TO PROVIDE ISOPROPYL ALCOHOL.
P140021|S002|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0416|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV II IMMUNOASSAY|MZO|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/17/2015|04/12/2016|||APPR|Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 602 analyzer.  The device, as modified, will be marketed under the trade name Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV and is indicated for:   Elecsys Anti-HCV II Immunoassay:  Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate).  Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection.  The test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 601 and cobas e 602 immunoassay analyzers. Elecsys PreciControl Anti-HCV:  Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCVimmunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers and the Elecsys Anti-HCV II immunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers.
P000015|S012|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Implant, auditory brainstem|NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT|MHE|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/18/2015|06/13/2016|||APPR|Approval for the Nucleus ABI541 Auditory Brainstem Implant, a modification to the existing ABI24M device, which is intended to restore a level of auditory sensation via electrical stimulation of the cochlear nucleus in individuals 12 years of age or older who have been diagnosed with Neurofibromatosis Type 2 (NF2). Implantation may occur during first or second side tumor removal or in patients with previously removed acoustic tumors bilaterally. Because the surgical procedure for tumor excision and electrode placement eliminates residual hearing, preoperative audiological criteria are not relevant. This supplement also requested approval for a new bodyworn battery pack compatible with the Nucleus 6 Sound Processor, and the ability to program ABI541 recipients using the Advanced Combination Encoder (ACE) sound coding strategy.
P030017|S244|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/15/2016|||OK30|TO ADD AN ALTERNATE SUPPLIER FOR CERTAIN CAPACITORS USED IN THE PRECISION IPG'S PCBA.
P890003|S346|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARE LINK PATIENT MONITOR|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2015|02/22/2016|||APPR|Approval for firmware updates to the MyCareLink patient home monitor.
P980016|S563|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI, EVERA, MARQUIS, SECURA, MAXIMO II, INTRINSIC, PROTECTA, PROTECTA XT, VIRTUOSO II|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2015|02/22/2016|||APPR|Approval for firmware updates to the MyCareLink patient home monitor.
P980035|S450|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA, ADVISA, ADVISA MRI,ENPULSE, KAPPA|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2015|02/22/2016|||APPR|Approval for firmware updates to the MyCareLink patient home monitor.
P010015|S288|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2015|02/22/2016|||APPR|Approval for firmware updates to the MyCareLink patient home monitor.
P010031|S524|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|VIVA, BRAVA, PROTECTA, PROTECTA XT, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II, INSYNC II PROTECT|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2015|02/22/2016|||APPR|Approval for firmware updates to the MyCareLink patient home monitor.
P090013|S211|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2015|02/22/2016|||APPR|Approval for firmware updates to the MyCareLink patient home monitor.
P960028|S038|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM 3-PC MULTIFOCAL|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/12/2016|||OK30|TO ADD 2 NEW CONTRACTORS TO PURIFY THE MONOMERS AND CROSS-LINKERS TO PRODUCE THE SILICONE MATERIAL USED IN THE ABOVE INTRAOCULAR LENSES.
P980040|S064|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR 3PC & 1PC MONOFOCAL; TECNIS 1PC MONOFOCAL, 1PC MULTIFOCAL AND 1PC TORIC MONOFOCAL, 1PC OPTIBULE & 3PC OPTIBLUE|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/12/2016|||OK30|TO ADD 2 NEW CONTRACTORS TO PURIFY THE MONOMERS AND CROSS-LINKERS TO PRODUCE THE SILICONE MATERIAL USED IN THE ABOVE INTRAOCULAR LENSES.
P080010|S012|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS 3PC MULTIFOCAL|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/12/2016|||OK30|TO ADD 2 NEW CONTRACTORS TO PURIFY THE MONOMERS AND CROSS-LINKERS TO PRODUCE THE SILICONE MATERIAL USED IN THE ABOVE INTRAOCULAR LENSES.
P990080|S040|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TENIS 3-PC MONOFOCAL-ZA9003|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/12/2016|||OK30|TO ADD 2 NEW CONTRACTORS TO PURIFY THE MONOMERS AND CROSS-LINKERS TO PRODUCE THE SILICONE MATERIAL USED IN THE ABOVE INTRAOCULAR LENSES.
P040045|S054|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON(SENOFILCON A) BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/20/2016|||OK30|IMPLEMENTATION OF AN ALTERNATE CATALYST IN RAW MATERIAL PROCESS FOR A SENOFILCON A MONOMER COMPONENT OF VISTAKON (SENOFILCON A) BRAND CONTACT LENSES.
P030002|S037|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS|MJP|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/18/2015|02/09/2016|||APPR|Approval of the following changes to the post-approval study for the device: administrative changes, including changes to personnel and organization and changes to the informed consent form.
P880086|S267|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|ASSURITY AND ENDURITY CORE FAMILY OF PACEMAKERS|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/18/2015|01/30/2016|||APPR|APPROVAL FOR AN ALTERNATE HYBRID ASSEMBLY FOR USE IN THE DEVICES.
P140031|S005|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/18/2015|01/04/2016|||OK30|MANUFACTURING LINE CHANGE AND THE USE OF AMMONIUM PERFLUOROOCTANOATE (APFO) FREE RESIN.
P010019|S043|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A & B SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/21/2015|01/15/2016|||OK30|THE IMPLEMENTATION OF AN ALTERNATE RAW MATERIAL SUPPLIER AND AN ANALYTICAL TEST METHOD.
P910077|S151|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Pacemaker/icd/crt non-implanted components|LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2015|02/05/2016|||APPR|Approval for software changes to the patient management system.
P960040|S362|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2015|02/05/2016|||APPR|Approval for software changes to the patient management system.
P010012|S408|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, CRT-D RESYNCHRONIZATION DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2015|02/05/2016|||APPR|Approval for software changes to the patient management system.
P030005|S131|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE, INTUA, VISIONIST, VALITUDE CRT-P RESYNCHRONIZATION DEVICES|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2015|02/05/2016|||APPR|Approval for software changes to the patient management system.
N970003|S184|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO, FORMIO ESSENTIO, ACCOLADE, PROPONENT, AND ALTRUA 2 SUPPORTED BY LATITUDE CONSULT ONLY) (PACE|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2015|02/05/2016|||APPR|Approval for software changes to the patient management system.
P110042|S057|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM (SUBCUTANEOUS ICD DEVICES)|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|12/21/2015|02/05/2016|||APPR|Approval for software changes to the patient management system.
P030017|S245|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/21/2015|07/28/2016|||APPR|Approval for a modification to the Precision Spectra Implantable Pulse Generator (IPG) Header for improved manufacturability.
P130018|S001|UROMEDICA INC|1840 BERKSHIRE LANE N||PLYMOUTH|MN|55441||Device, incontinence, mechanical/hydraulic|PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN|EZY|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/21/2015|11/02/2016|||APPR|Approval of the protocol for the post-approval study protocol.
P050037|S070|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|06/02/2016|||APPR|Approval for relocation of an automatic packing line within the approved facility.
P050052|S082|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE & RADIESSE (+) LIDOCAINE DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|06/02/2016|||APPR|Approval for relocation of an automatic packing line within the approved facility.
P080006|S086|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEADS|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P010015|S289|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P030036|S081|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P060039|S068|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P090013|S212|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P120017|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MYOCARDIAL PACING LEAD|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P890023|S024|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/11/2016|||OK30|RELOCATION OF THE BIOMEDICS TORIC WET CELL, INSTALLATION OF A NEW TC20I UNIT IN THE BIOMEDICS TORIC QA STATION AND A SOFTWARE UPDATE FOR QA FINAL INSPECTION PRIOR TO MEASUREMENT OF TORIC LENSES.
P830061|S125|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD; VITATRON EXCELLENCE LEAD PS+LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P850089|S115|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD; CAPSURE Z NOVUS LEAD; VITATRON EXCELLENCE SS+LEAD; VITATRON IMPULSE II LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P890003|S347|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2 LEAD; VITATRON BRILLIANT S+VDD LEAD;VITATRON BRILLAIANT S+VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P100034|S015|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|OPTUNE|NZK|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/22/2015|07/13/2016|||APPR|Approval for a smaller, lighter weight version of the original Optune™ System, referred to as the Optune™ System (NovoTTF-200A System).
P920015|S169|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD; TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P930039|S145|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; SUREFIX LEAD;VITATRON CRYSTALLINE ACTIVE FIXATION LEAD; VITATRON CRYSTALLINE ACT|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P950024|S066|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P980050|S102|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/22/2015|01/13/2016|||OK30|IMPLEMENTATION OF THE LEADS SERIAL NUMBER GENERATOR EQUIPMENT CONTROLLER VERSION 4.0.0.
P010032|S110|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EXTERNAL PULSE GENERATOR, 2 PORT HEADER, ADHESIVE POUCH, EPG; NON-ADHESIVE POUCH WITH BELT.|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2015|03/22/2016|||APPR|Approval for a material change to the approved pouch used with the External Pulse Generator, 16 Channel (Model 3599).
P840001|S319|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2015|01/22/2016|||OK30|THE TRANSFER OF RECEIVING AND INCOMING INSPECTION ACTIVITIES FOR DEVICE COMPONENTS USED IN THE MANUFACTURE OF MEDTRONIC NEUROMODULATION THERAPY DELIVERY PRODUCTS TO ALTERNATE FACILITIES.
P960009|S244|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2015|01/22/2016|||OK30|THE TRANSFER OF RECEIVING AND INCOMING INSPECTION ACTIVITIES FOR DEVICE COMPONENTS USED IN THE MANUFACTURE OF MEDTRONIC NEUROMODULATION THERAPY DELIVERY PRODUCTS TO ALTERNATE FACILITIES.
P000025|S084|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|Cochlear implant with combined electrical stimulation and acoustic amplification|MED-EL COCHLEAR IMPLANT SYSTEM|PGQ|EN|Panel Track|Change Design/Components/Specifications/Material|N|12/23/2015|09/15/2016|16M-2974|09/26/2016|APPR|Approval for expanding the indications to include the Electro-acoustic Stimulation (EAS) system that is intended to provide electrical stimulation to the mid- to high-frequency region of the cochlea and acoustic amplification to the low-frequency regions, for candidates with residual low frequency hearing sensitivity.   The MED-EL EAS System is indicated for partially deaf individuals aged 18 years and older who have residual hearing sensitivity in the low frequencies sloping to a severe/profound sensorineural hearing loss in the mid to high frequencies, and who obtain minimal benefit from conventional acoustic amplification. Typical preoperative hearing of candidates ranges from normal hearing to moderate sensorineural hearing loss in the low frequencies (thresholds no poorer than 65 dB HL up to and including 500 Hz) with severe to profound mid- to high-frequency hearing loss (no better than 70 dB HL at 2000 Hz and above) in the ear to be implanted.  For the non-implanted ear, thresholds may be worse than the criteria for the implanted ear, but may not be better.  The CNC word recognition score in quiet in the best-aided condition will be 60% or less, in the ear to be implanted and in the contralateral ear. Prospective candidates should go through a suitable hearing aid trial, unless already appropriately fit with hearing aids.
P140011|S002|SIEMENS MEDICAL SOLUTIONS USA, INC.|51 VALLEY STREAM PKWY.||MALVERN|PA|19355|1406|Digital breast tomosynthesis|MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION|OTE|RA|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|12/23/2015|01/13/2016|||APPR|APPROVAL TO IMPLEMENT A SOFTWARE UPDATE THAT RESOLVES AN ERROR THAT MAY OCCUR DURING TOMOSYNTHESIS RECONSTRUCTION WITH A BREAST THICKNESS LARGER THAN 90 MM.
P970051|S140|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2015|06/20/2016|||APPR|Approval for the optional acoustic component amplifies low frequency sound, and sends it into the ear canal. The acoustic component is intended to provide access to these low frequency sounds for some Cochlear Nucleus implant recipients.The acoustic component is indicated for recipients of traditional Cochlear Nucleus implants with unaided air conduction thresholds less than or equal to 85 dB HL between 125 Hz and 2000 Hz following surgery. The acoustic component should only be used when behavioural audiometric thresholds can be obtained and the recipient can provide feedback regarding sound quality.Speech perception testing should be completed before and after fitting with the acoustic component to ensure that the recipient performs as well, if not better, with the acoustic component than without it.
P130005|S010|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2015|01/21/2016|||OK30|A MANUFACTURING PROCESS CHANGE TO THE JOINING OF THE CROWN TO THE DRIVESHAFT OF THE OAS.
P870072|S061|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2015|01/21/2016|||OK30|REQUESTED A STERILIZATION CYCLE CHANGE FOR THE THORATEC VENTRICULAR ASSIST DEVICE SYSTEM.
P060040|S049|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/23/2015|01/21/2016|||OK30|REQUESTED A STERILIZATION CYCLE CHANGE FOR THE THORATEC HEARTMATE II VENTRICULAR ASSIST DEVICE SYSTEM.
P030036|S082|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2015|03/03/2016|||APPR|Approval for shelf life extension.
P090022|S026|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|12/23/2015|03/28/2016|||APPR|Approval to reduce the center thickness of the currently approved Softec Model HD intraocular lens and assign it the new model designation Softec HDM intraocular lens.
P000008|S036|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/21/2015|02/08/2016|||APPR|Approval of the following changes to the post-approval study for the device: Addition of a Canadian site, which has been operating under the larger, international HERO study protocol.
P050023|S094|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4)|MRM|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2015|05/02/2016|||APPR|Approval for full body scanning of the ProMRI CRT-D System.
P950037|S161|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, permanent, implantable|SETROX S 53, SAFIO S 53|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2015|05/02/2016|||APPR|Approval for full body scanning of the ProMRI CRT-D System.
P000009|S065|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROGRAMMER SOFTWARE (1507.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2015|05/02/2016|||APPR|Approval for full body scanning of the ProMRI CRT-D System.
P070008|S070|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|COROX OTW 75 BP & 85 BP; COROX OTW-L 75 BP & 85 BP; COROX OTW-S 75 BP & 85 BP|NKE|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2015|05/02/2016|||APPR|Approval for full body scanning of the ProMRI CRT-D System.
P860003|S082|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/24/2015|01/21/2016|||OK30|A CHANGE IN THE INSPECTION PROCESS FOR CELLEX PROCEDURAL KIT CARTONS PRIOR TO THEIR PLACEMENT IN THEIR SHIPPING PALLETS.
P980035|S451|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADAPTA  DR IPG, ADVISA DR MRI IPG, ADVISA DR MRI IPG, RELIA IPG,|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P030036|S083|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P060039|S069|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|ATTAIN STARFIX LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P080006|S087|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P090013|S213|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD, REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P830061|S126|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P850089|S116|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE SP NOVUS LEAD; CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD.|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P890003|S348|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2 LEAD. VITATRON BRILLIANT S+ VDD LEAD, VITATRON BRILLIANT S+VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P870076|S019|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|DISPOSABLE FALOPE-RING BAND APPLICATOR KITS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/27/2016|||OK30|CHANGE IN SUPPLIERS FROM SENIOR OPERATIONS LLC (FORMERLY KNOWN AS GORMAC PRODUCTS) TO GYRUS ACMI NORWALK, OH FACILITY (ESTABLISHMENT REGISTRATION NUMBER 1519132) FOR THE MANUFACTURE OF THE FOLLOWING COMPONENTS OF YOUR DEVICE:  FALOPE RING BAND APPLICATOR FORCEPS INNER TUBE (PART NUMBER 005261); OUTER TUBE (PART NUMBER 005262); AND CANNULA SLEEVE (PART NUMBER 004557-3).
P010047|S042|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/26/2016|||OK30|APPROVAL OF ALTERNATE SUPPLIERS OF TESTING REAGENTS USED FOR ANALYTICAL TESTING (I.E., THE BIURET TEST REAGENT AND PROTEIN PRIMARY STANDARD) OF THE TOTAL PROTEIN CONTENT OF THE HUMAN SERUM ALBUMIN (HAS) COMPONENT OF THE PROGEL PALS FINISHED DEVICE.
P120010|S082|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/27/2016|||OK30|THE APPROVAL OF A TRANSITION OF THE MANUFACTURING OF THE TYVEK LIDS USED FOR PACKAGING THE ENLITE SENSOR COMPONENT FROM THE SUPPLIER'S FACILITY IN PHILADELPHIA TO OSHKOSH, WISCONSIN.  ADDITIONALLY, THE FACILITY TRANSITION INCLUDES NEW MANUFACTURING ASSETS INCLUDING COATER AND DIE CUT LID PRESS.  THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEMS.
P840001|S320|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|Acceptance for implementation of new performance software and re-packaging of selective returned products at Medtronics distribution center in Memphis, Tennessee.
P960009|S245|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576||ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM||NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|Acceptance for implementation of new performance software and re-packaging of selective returned products at Medtronics distribution center in Memphis, Tennessee.
P970004|S209|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|Acceptance for implementation of new performance software and re-packaging of selective returned products at Medtronics distribution center in Memphis, Tennessee.
P080025|S104|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|Acceptance for implementation of new performance software and re-packaging of selective returned products at Medtronics distribution center in Memphis, Tennessee.
P030036|S084|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SELECTSECURE LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/21/2016|||OK30|REQUESTED UPDATES TO THE STAINLESS STEEL COMPONENT PASSIVATION PROCESSES FOR THE DEVICES.
P090013|S214|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/21/2016|||OK30|REQUESTED UPDATES TO THE STAINLESS STEEL COMPONENT PASSIVATION PROCESSES FOR THE DEVICES.
P900061|S138|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P920015|S170|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD, HV SPLITTER/ADAPTOR KIT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P100047|S071|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/15/2016|||OK30|IMPLEMENTATION OF A NEW CLEANING AGENT AT ONE OF THE MACHINED PARTS SUPPLIERS.
P930039|S146|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD. CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITRATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON  CRYSTALLINE|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P980050|S103|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P010015|S290|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P950024|S067|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSURE EPICARDIAL PACING LEAD|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P980016|S564|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD. EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA X|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P120017|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MYOCARDIAL PACING LEAD|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P140013|S001|MINERVA SURGICAL|101 SAGINAW DRIVE||REDWOOD CITY|CA|94063||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MINERVA ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|12/28/2015|02/23/2016|||APPR|Approval for a software modification to the Minerva RF Controller software to reduce the occurrence of false error codes.
P900061|S139|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EPICARDIAL PATCH LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/21/2016|||OK30|REQUESTED UPDATES TO THE STAINLESS STEEL COMPONENT PASSIVATION PROCESSES FOR THE DEVICES.
P930029|S054|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF MARINR 5F SC, RF MARINR 5F SCXL, RF MARINR 5F SCXS, RF MARINR 5F SCXXL|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/21/2016|||OK30|REQUESTED UPDATES TO THE STAINLESS STEEL COMPONENT PASSIVATION PROCESSES FOR THE ABOVE REFERENCED DEVICES.
P010031|S525|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D , PROTECTA CRT-D, PROT||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/25/2016|||OK30|IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
P930039|S147|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/21/2016|||OK30|REQUESTED UPDATES TO THE STAINLESS STEEL COMPONENT PASSIVATION PROCESSES FOR THE DEVICES.
P020045|S071|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/14/2016|||OK30|ACCEPTANCE OF CHANGES PERFORMED DURING SUB-COOLER PERFORMANCE TESTING.
P020045|S072|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION SYSTEM|LPB|CV|30-Day Notice||N|12/28/2015|01/27/2016|||OK30|ACCEPTANCE FOR NEW ASSEMBLY AREA FOR REPLACEMENT PARTS THAT ARE USED FOR CONSOLE REPAIR AND SERVICING.
P840062|S054|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/28/2015|01/26/2016|||OK30|ADDITION OF THE KINEMATICA POLYTRON PT 2500E MIXER TO IMPROVE THE TEST METHOD OF DISPERSION SAMPLES PREPARATION TO PROVIDE HOMOGENOUS SAMPLING FOR PERCENT SOLIDS TESTING.
P140015|S006|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Sensor, glucose, invasive|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|12/29/2015|03/24/2016|||APPR|Approval for a change in packaging for the replacement pump of the t:slim G4 insulin pump system with Dexcom G4 Platinum CGM.
P130025|S002|KONING CORPORATION|150 Lucius Gordon Drive|Suite 112|W Henrietta|NY|14586||Cross-sectional mammographic xray system|KONING BREAST CT (MODEL CBCT 1000)|OLQ|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/28/2015|10/06/2016|||APPR|Approval for changes to the patient table shape; detector upgrade; new quality control phantom and labeling; x-ray generator upgrade; image storage, display server and command processor upgrade; minor replacements of electrical components.
P140015|S007|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Sensor, glucose, invasive|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2015|01/28/2016|||OK30|CHANGES TO THE PACKAGING VERIFICATION PROCESSES TO REPLACE 100% VISUAL INSPECTION WITH 100% PACKAGE CONTENTS VERIFICATION USING VALIDATED CHECKWEIGHT SCALE, AND CHANGES TO THE LABELING VERIFICATION PROCESS TO REPLACE 100% VISUAL VERIFICATION WITH ONCE-DAILY VISUAL INSPECTION OF A RETAINED LABEL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM.
P140015|S008|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Sensor, glucose, invasive|T:SLIM G4 INSULIN PUMP WITH DEXCON G4 PLATINUM CGM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2015|01/22/2016|||OK30|TO MODIFY THE GEARBOX RUN-IN PRODUCTION PROCESS STEP TO INCLUDE THE USE OF PRODUCTION MOTORS RATHER THAN TEST MOTORS.
P020056|S032|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS.|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/30/2015|08/25/2016|||APPR|Approval for removal of the DSMB from the BIFS-001 study protocol.
P040021|S027|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|SJM BIOCOR AND EPIC VALVES|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/30/2015|10/14/2016|||APPR|Approval for the replacement of a cleaning detergent used in the manufacturing of Biocor and Epic valves.
P040046|S014|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|12/30/2015|08/25/2016|||APPR|Approval for removal of the DSMB from the BIFS-001 study protocol.
P150013|S001|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC 22C3 PHARMDX|PLS|PA|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|12/31/2015|10/24/2016|||APPR|Approval for PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS greater than or equal to 1% and high PD-L1 expression if TPS is greater than or equal to 50%. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances.  This device is for in vitro diagnostic use.
P110002|S013|LDR Spine USA|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2015|01/21/2016|||OK30|FOUR MANUFACTURING CHANGES, WHICH INCLUDED REPLACEMENT OF A WIRE CUTTING MACHINE, ADDITION OF NEW POLISHING STATIONS, UPDATES TO LASER MARKING MACHINES, AND THE ADDITION OF UPDATED TENSILE TESTING MACHINES.
P030011|S038|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2015|02/22/2016|||APPR|Approval for a location change for a secondary supplier as well as the addition of 3 new machines at the same secondary supplier.
P110009|S013|LDR SPINE USA INC.|13785 RESEARCH BOULEVARD|SUITE 200|AUSTIN|TX|78750||PROSTHESIS, INTERVERTEBRAL DISC|MOBI-C CERVICAL DISC PROSTHESIS|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|12/31/2015|01/21/2016|||OK30|FOUR MANUFACTURING CHANGES, WHICH INCLUDED REPLACEMENT OF A WIRE CUTTING MACHINE, ADDITION OF NEW POLISHING STATIONS, UPDATES TO LASER MARKING MACHINES, AND THE ADDITION OF UPDATED TENSILE TESTING MACHINES.
P040012|S056|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|RX ACCULINK CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/04/2016|03/04/2016|||APPR|Approval of the following changes to the post-approval study for the device:request to modify the conditions of approval follow-up requirement from 3 to 2 years.
P970051|S141|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2016|02/04/2016|||OK30|Introduction of a revised cleaning process for the CI24RE(CA), CI24RE(ST), and CI422 implant electronic assemblies.
P130016|S014|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2016|02/04/2016|||OK30|Introduction of a revised cleaning process for the Nucleus Hybrid L24 implant electronic assemblies.
P040044|S069|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/05/2016|01/31/2016|||OK30|TO SOURCE POLYETHYLENE GLYCOL (PEG) RAW MATERIALS USED IN THE HYDROGEL SEALANT OF MYNX DEVICES FROM AN ALTERNATE MANUFACTURING FACILITY.
P970051|S142|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2016|02/05/2016|||OK30|Introduction of a pre-bake of the electronic assembly prior to pre-tinning and soldering of the implant feedthrough for the Nucleus Freedom cochlear implants.
P130016|S015|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2016|02/05/2016|||OK30|Introduction of a pre-bake of the electronic assembly prior to pre-tinning and soldering of the implant feedthrough for the Nucleus Hybrid L24 implant.
P040037|S088|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2016|02/04/2016|||OK30|Use of an alternate resin in the manufacture of ePTFE fiber of the zipper component of the device, modification to raw material specification requirement and obtaining the alternate resin directly in the form of precursor tapes from the existing supplier.
P130006|S027|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2016|02/04/2016|||OK30|Use of an alternate resin in the manufacture of ePTFE fiber of the zipper component of the device, modification to raw material specification requirement and obtaining the alternate resin directly in the form of precursor tapes from the existing supplier.
P040043|S080|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2016|02/01/2016|||OK30|Use of a PTFE leash line fiber made from PTFE precursor tape provided by an approved supplier.
P150003|S004|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIMUM CORONARY STENT SYSTEM MONORAIL & OVER-THE-WIRE.|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/06/2016|02/04/2016|||OK30|Change to the component inspection process.
P040044|S070|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE )|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/07/2016|03/10/2016|||APPR|Approval for an extension of the Mynx Ace Vascular Closure Device shelf life to 18 months.
P130026|S014|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2016|02/01/2016|||OK30|Acceptance of an alternate supplier for proximal optical fiber components and acceptance of a proposed rework process for distal optical fiber components.
P120016|S019|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2016|02/10/2016|||OK30|Relocation of the Key Fusing subassembly to the manufacturing facility in Guayamas, Sonora, Mexico.
P100026|S041|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2016|02/05/2016|||OK30|Updates/improvements to the LW5A laser welder hardware, operating software, and resulting processes.
P920015|S171|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/07/2016|02/02/2016|||OK30|Change to the location of the supplier of the lead inner tray and the addition of venting channels to the inner tray package; and implementation of an automated documentation process for functional resistance testing equipment.
P040005|S012|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|HER2 IQFISH PHARMDX|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2016|01/29/2016|||OK30|CHANGE OF THE IN-PROCESS QC "METAPHASE FISH TEST', WITH CHANGE NUMBER R02285.  PMA APPROVED DEVICES AFFECTED BY THE CHANGE ARE:  HER2 CISH PHARMDX KIT AND HER2 IQFISH PHARMDX.
P100024|S008|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2016|01/29/2016|||OK30|CHANGE OF THE IN-PROCESS QC "METAPHASE FISH TEST', WITH CHANGE NUMBER R02285.  PMA APPROVED DEVICES AFFECTED BY THE CHANGE ARE:  HER2 CISH PHARMDX KIT AND HER2 IQFISH PHARMDX.
N970003|S185|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO; PROPONENT; ACCOLADE ; ALTRUA 2 PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2016|02/03/2016|||OK30|Vertical integration of the manufacturing of the spring connector block housings for the devices.
P030005|S132|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE , VALITUDE X4 CRT-PS|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/08/2016|02/03/2016|||OK30|Vertical integration of the manufacturing of the spring connector block housings for the devices.
P920015|S172|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2016|02/01/2016|||OK30|Implementation of the Leads Serial Number Generator Equipment Controller Version 4.0.0.
P980037|S055|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA XMI THROMBECTOMY SET; ANGIOJET ULTRA SPIROFLEX & SPIROFLEX VG THROMBECTOMY SET; ANGIOLET ULTRA DISTAFLEX|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2016|02/10/2016|||OK30|Change to the sub-assembly manufacturing process.
P980016|S565|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI; EVERA S DR;EVERA XT DR; EVERA XT VR; MAXIMO II; PROTECTA; PROTECTA XT; SECURA ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/11/2016|03/10/2016|||APPR|Approval for the addition of a passivation layer to the XD429 component used in the hybrid charging circuit and the associated manufacturing changes.
P010031|S526|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA;BRAVA QUAD; CONCERTO II;CONSULTA;MAXIMO II;PROTECTA;PROTECTA XT;VIVA QUAD S;VIVA QUAD XT;VIVA S;VIVA XT CRT-DS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/11/2016|03/10/2016|||APPR|Approval for the addition of a passivation layer to the XD429 MOSFET used in the hybrid charging circuit and changes in the manufacturing process of the XD429
P050006|S049|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/11/2016|02/08/2016|||OK30|Implement alternate equipment to form the delivery system mandrel.
P120014|S006|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||Somatic gene mutation detection system|THXID-BRAF KIT|OWD|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/11/2016|04/05/2016|||APPR|Approval for a change in the THxID-BRAF software to detect a specific fallback threshold value within the SDS file and in such case prevent the generation of a mutation report.
P860003|S083|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT|LNR|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/2016|04/08/2016|||APPR|Approval for a change in the color scheme of the anticoagulant line from green-striped to orange-striped, and in the color of the anticoagulant spike chamber from white to orange.
P910023|S367|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT+ FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2016|02/08/2016|||OK30|Use of a new connector bore plug in the parylene coating process.
P030054|S297|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE+UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DIVICES|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/12/2016|02/08/2016|||OK30|Use of a new connector bore plug in the parylene coating process.
P980035|S452|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG; ADVISA DR MRI IPG|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/2016|03/01/2016|||APPR|Approval for a modified shield fastener bracket.
P090013|S215|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/12/2016|03/01/2016|||APPR|Approval for a modified shield fastener bracket.
P870076|S020|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|DISPOSABLE FALOPE-RING BANK APPLICATOR KITS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2016|02/09/2016|||OK30|Change in suppliers from Senior Operations LLC (formerly known as GA MFG Precision) to C&M Machine for the manufacture of the following components of the subject device:  1) Locating Pin (part number 005267); and 2) Vercap Insert Seal Base (part number 005137).
P910001|S083|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/13/2016|02/12/2016|||OK30|Change to the component manufacturing process.
P110008|S004|PARADIGM SPINE, LLC|505 PARK AVENUE, 14TH  FLOOR||NEW YORK|NY|10022||Prosthesis, spinous process spacer/plate|coflex Interlaminar Technology|NQO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2016|02/09/2016|||OK30|Addition of a second supplier for the instruments with the following part numbers: UAT00008, UAT00010, UAT00012, UAT00014, UAT00016, UBT10008, UBT10010, UBT10012, UBT10014, UBT10016, UAT10100, UAT10200, UAT10300, UAT20100, and UAT20110.
P980037|S056|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY, ANGIOJ|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2016|02/12/2016|||OK30|Change to the component manufacturing process.
P920015|S173|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|SPRINT QUATTRO LEAD ; SPRINT QUATTRO LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/14/2016|02/09/2016|||OK30|Implementation of a peel strength test of blister packages as a process monitoring mechanism.
P040043|S081|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2016|02/11/2016|||OK30|Use of a new oven to process samples of the GORE TAG Thoracic Endoprosthesis for fatigue life testing.
P860057|S141|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS. RSR PERICARDIAL AORTIC BIOPROSTHESIS, MAGNA PERICARDIAL A|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2016|02/10/2016|||OK30|Modify the bioburden recovery efficiency for in-process bioburden testing.
P130009|S045|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2016|02/10/2016|||OK30|Modify the bioburden recovery efficiency for in-process bioburden testing.
P140031|S006|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2016|02/10/2016|||OK30|Modify the bioburden recovery efficiency for in-process bioburden testing.
P130030|S018|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2016|02/12/2016|||OK30|Change to the stent delivery catheter inspection process.
P050010|S017|SYNTHES SPINE|325 Paramount Drive||Raynham|MA|02767||PROSTHESIS, INTERVERTEBRAL DISC|PRODISC-L TOTAL DISC REPLACEMENT|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/15/2016|02/04/2016|||OK30|Change in sterile package sealing pressure parameter (from 60 psi to 90 psi).
P140003|S007|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA 2.5 SYSTEM|OZD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|01/25/2016|||OK30|TO ADD A SECOND SUPPLIER FOR THREE SUB-ASSEMBLIES USED TO BUILD THE FINAL IMPELLA PURGE CASSETTE.
P980035|S453|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/11/2016|||OK30|Updates to the final functional tester used at the final device assembly manufacturing facilities.
P860004|S245|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/18/2016|||OK30|Sub-tier plating supplier change and accompanying minor manufacturing changes for the alarm spring component of the Model 8637 SynchroMed®II pump.
P040040|S026|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/19/2016|03/18/2016|||APPR|Approval of the following changes to the post-approval study for the device:  plan to increase subject enrollment utilizing retrospective data collection.
P140019|S002|CERAPEDICS, LLC|11025 DOVER STREET|SUITE 1600|WESTMINSTER|CO|80021||Filler, bone void, synthetic peptide|I-FACTOR PEPTIDE ENHANCED BONE GRAFT|NOX|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|03/18/2016|||APPR|Approval for the inclusion of additional graft sizes, i.e., 1.0 and 2.5cc, to the approved 5.0cc graft.
P980040|S065|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS|HQL|OP|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/19/2016|07/15/2016|16M-2184|07/25/2016|APPR|Approval for the Tecnis Symfony Extended Range of Vision Intraocular Lens.  The TECNIS® Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed.  The lens mitigates the effects of presbyopia by providing an extended depth of focus.  Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity.  The Model ZXR00 IOL is intended for capsular bag placement only.  The TECNIS® Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed.  The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity.  The Model Series ZXT IOLs are intended for capsular bag placement only.
P010032|S111|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI, PROTEGE, IPG PROTEGE 3.01, IPG PROTEGE MRI|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/17/2016|||OK30|Use of alternative batch sampling methods for bacterial endotoxin testing (BET) at the SJM Arecibo, Puerto Rico facility.
P130009|S046|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS EXPANDABLE INTRODUCER SHEATH SET|NPT|CV|Special (Immediate Track)||N|01/19/2016|02/16/2016|||APPR|Approval for the addition of a visual inspection and functional testing of a component of the Edwards Expandable Introducer Sheath Set.
P080006|S088|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD Models 4196, 4296, 4396|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/12/2016|||OK30|Addition of a new crimper system used to crimp the distal electrode component.
P910066|S028|DJO, LLC|1430 DECISION STREET||VISTA|CA|92081|8553|Stimulator, bone growth, non-invasive|OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS|LOF|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/19/2016|02/18/2016|||APPR|Approval for the labeling to be in conformance with IEC 60601-1-6 ED.3.1, IEC 60601-1-2, ANSI/AAMI ES 60601-1:2005/A1:2012 and IEC 60601-11:2011.
P030054|S298|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKFLEX U AND QUARTET CRT LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/17/2016|||OK30|Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.
P950022|S091|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Permanent defibrillator electrodes|DURATA AND OPTISURE HV LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/17/2016|||OK30|Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.
P130028|S002|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/17/2016|||OK30|Alternate supplier for a component of the device battery packs.
P960030|S041|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ISOFLEX OPTIM LV LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/17/2016|||OK30|Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.
P960013|S079|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Permanent defibrillator electrodes|TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/19/2016|02/17/2016|||OK30|Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.
P110010|S118|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS PREMIER EVEROLIMUS-ELUTING PLANTINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/20/2016|04/19/2016|||APPR|Approval for a change in colorant used in the distal tip component of the delivery catheter.
P130030|S019|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/20/2016|04/19/2016|||APPR|Approval for a change in colorant used in the distal tip component of the delivery catheter.
P090022|S027|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2016|02/12/2016|||OK30|Installation of an additional steam sterilizer.
P960040|S363|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NG3 EXTENDED LIFE ICD: DYNAGEN, INOGEN, ORIGEN, NG2 5 MINI ICD DYNAGEN, INOGEN,|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/2016|03/03/2016|||APPR|Approval for updates to the Physician’s Technical Manuals for ICDs and CRT-Ds
P010012|S409|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable cardioverter defibrillator (non-CRT)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT|LWS|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/2016|03/03/2016|||APPR|Approval for updates to the Physician’s Technical Manuals (PTMs) for ICDs and CRT-Ds
P130019|S007|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2016|02/12/2016|||OK30|Material change for the flux used during in-process rework, the use of a 10 zone Vitronics reflow oven, machine placement of the RF shield component, clarifying process instructions, and use of the alternate Mydata assembly line for the Model 2402 Mobile Charger.
P130009|S047|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/20/2016|02/16/2016|||APPR|Approval for implementation of an additional in-process inspection of the introducer in the Edwards Expandable Introducer Sheath Set.
P970058|S027|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Analyzer,medical image|IMAGE CHECKER, IMAGE CHECKER LICENSE|MYN|RA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/20/2016|04/26/2016|||APPR|Approval for a manufacturing site located at Hologic, Inc., 35 Crosby Drive, Bedford, Massachusetts.
P050023|S095|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PROMRI ICD SYSTEM|MRM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/21/2016|06/16/2016|||APPR|Approval for the ProMRI Full Body Scan ICD System of the post-approval study protocol.
P060040|S050|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/21/2016|02/18/2016|||APPR|Approval for revisions to the labeling for the HeartMate® II Left Ventricular Assist System with Pocket Controller and HeartMate® II Left Ventricular Assist System with Pocket Controller and Mobile Power Unit (MPU).
P960030|S042|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|IsoFlex Models 1642T, 1646T, 1944, 1948|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2016|02/17/2016|||OK30|Add an alternate supplier for the connector pins.
P030011|S039|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA CAMPANION 2 DRIVER SYSTEM|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/21/2016|04/15/2016|||APPR|Approval for a design change in the power cord.
P030054|S299|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QuickFlex u Model 1258T|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2016|02/17/2016|||OK30|Add an alternate supplier for the connector pins.
P130026|S015|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Special (Immediate Track)|Change Design/Components/Specifications/Material|N|01/21/2016|02/19/2016|||APPR|Approval for modifications to the definition of the LSI multi-parameter index in the TactiSys Quartz Instructions for Use document.
P140020|S005|MYRIAD GENETIC LABORATORIES|320 Wakara Way||Salt Lake City|UT|84108||Cancer-related germline gene mutation detection system|BRACANALYSIS CDX DEVICE|PJG|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/21/2015|02/18/2016|||OK30|New polymerase to be used in DNA sequencing process.
P040024|S090|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/22/2016|06/01/2016|||APPR|Approval for an additional control step for the filtration of lidocaine.
P990004|S029|FERROSAN MEDICAL DEVICES A/S|P.O. BOX 151 ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, collagen based|SURGIFOAM ABSORBABLE GELATIN SPONGE,U.S.P.|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|04/07/2016|||OK30|Installation of two separate photocells on the multivac equipment that packs SURGIFOAM® Oral Sponge products.
P010030|S072|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2016|04/26/2016|||APPR|Approval for modifications to the currently approved garment.
P880086|S269|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|Victory Models 5816, 5810, 5610; Zephyr Models 5820, 5826, 5620, 5626; Accent Models PM1110, PM1210, PM2110,  PM2210; As|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/22/2016|||OK30|Changes to the final electrical test equipment.
P830055|S167|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Additional work to be performed at manual process stations and additional inspection steps.
P140031|S007|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS COMMANDER DELIVERY SYSTEM|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/08/2016|02/22/2016|||APPR|Approval for various design and manufacturing modifications to the Commander Delivery System.
P100031|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P110022|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P130015|S005|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBEAG IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P110035|S034|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|07/20/2016|||APPR|Approval for the addition of a sterilization chamber at the Synergy Health Ireland Limited, Tullamore facility.
P130024|S010|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX 035 DRUG COATED BALLOON PTA CATHETER|ONU|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/27/2016|03/10/2016|||APPR|Approval to the addition of a new balloon folding process, implementation of a new in-process leak detection test, changes to the sampling plan for an in-process assay test, and labeling changes for sheath compatibility, crossing profile, and recommended balloon inflation time.
P010001|S015|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/25/2016|||OK30|Additional ultrasonic cleaning and crack detection system.
P910023|S369|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|Ellipse DR Models CD2311-36, CD2311-36Q, CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC; Ellipse VR Models CD1311-36, CD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/22/2016|||OK30|Changes to the foil etching process and lid lip dimension for the high voltage capacitors.
P010001|S016|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/25/2016|||OK30|Addition of  a laser marking machine.
P880086|S270|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, permanent, implantable|Assurity Models PM1240, PM2240; Assurity+ Models PM1260, PM2260; Endurity Models PM1160, PM2160; Endurity Core Models CD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/22/2016|||OK30|Implementation of a visual inspection criterion used during the manufacturing of the hybrid assemblies.
P010032|S112|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/26/2016|||OK30|Change to the sampling interval for bioburden and bacterial endotoxin testing of the two process water systems at the Plano, Texas manufacturing facility.
P140009|S011|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES|MHY|NE|30-Day Notice||N|01/27/2016|02/26/2016|||OK30|Change to the sampling interval for bioburden and bacterial endotoxin testing of the two process water systems at the Plano, Texas manufacturing facility.
P110013|S059|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/27/2016|07/22/2016|||APPR|Approval to update the labeling for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System Instructions for Use (IFU) for both the Rapid Exchange (RX) and Over-The-Wire (OTW) delivery systems to include the most current clinical follow-up data for the Global RESOLUTE Clinical Trial Program and the Resolute Integrity US (RI-US) Primary Enrollment Group (PEG) Post-Approval Study.
P990012|S024|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P010054|S026|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P140021|S003|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0416|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV II IMMUNOASSAY|MZO|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P130017|S006|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/04/2016|||OK30|Change in test methodology for one of the incoming materials used in the Cologuard® sDNA based colorectal cancer screening test.
P150011|S001|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|PERCEVAL SUTURELESS HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Changes to the sterilization process parameters and valve storage solution testing.
P100032|S011|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P110025|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P110031|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY|LOM|MI|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|08/08/2016|||APPR|Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.
P990012|S025|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P010054|S027|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P090007|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV TEST SYSTEM|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P090008|S016|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV TEST SYSTEM|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P090009|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV TEST SYSTEM|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P100031|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P100032|S012|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P110022|S016|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P110025|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P110031|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM TEST SYSTEM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P140021|S004|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0416|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV II TEST SYSTEM|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|02/24/2016|||OK30|Relocation of manufacturing activities for processing human serum raw materials.
P130011|S003|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|THE SOLO SMART STENTLESS HEART VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|03/10/2016|||APPR|Approval for extension of the allowable in-process permanence times for two solutions used in the manufacturing process.
P150011|S002|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|THE PERCEVAL SUTURELESS HEART VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/27/2016|03/10/2016|||APPR|Approval for extension of the allowable in-process permanence times for two solutions used in the manufacturing process.
P860003|S084|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS CELLEX PROCEDURAL KIT|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2016|02/25/2016|||OK30|Addition of an alternate supplier for the drive tube subassembly of the CELLEX Procedural Kit.
P010001|S017|CERAMTEC GMBH|CERAMTEC-PLATZ 1-9|73207|PLOCHINGEN||73207||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRANSCEND HIP ARTICULATION SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2016|02/24/2016|||OK30|Addition of one ultrasonic cleaning system.
P020045|S073|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE|LPB|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|01/28/2016|08/31/2016|16M-2649|09/09/2016|APPR|Approval for the Freezor Xtra Cardiac CryoAblation Catheter, CryoConsole system, and related accessories.  The device is indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT). The Freezor Xtra catheter is also intended for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Freezor Xtra catheter freezes the target tissue and blocks the electrical conduction by creating an inflammatory response or cryonecrosis.
P130030|S020|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2016|02/26/2016|||OK30|Change to the terminal ethylene oxide sterilization process.
P110010|S119|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2016|02/26/2016|||OK30|Change to the terminal ethylene oxide sterilization process.
P060006|S071|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2016|02/26/2016|||OK30|Change to the terminal ethylene oxide sterilization process.
P010019|S044|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2016|02/23/2016|||OK30|Move manufacturing of semi-finished subassemblies for the Alcon class III Lotrafilcon A Soft Contact Lens from Duluth, Georgia, USA to Johor Malaysia.
P980040|S066|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS TORIC CALCULATOR|HQL|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|01/28/2016|08/16/2016|||APPR|Approval for a software update to your TECNIS® Toric Calculator to include the following:1) Prospective addition of the FDA-approved ZCT375 I0OL); and 2) Incorporation of an optional feature to add the posterior corneal astigmatism (PCA) factor into the toric lens calculation.
P140023|S003|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS KRAS MUTATION TEST|OWD|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|01/28/2016|04/25/2016|||APPR|Approval for the proposed formulation change (removal of anti-microbial agent ProClin 300) and process changes to production of KRAS reaction Mix, a component of cobas® KRAS Mutation Test.
P040043|S082|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2016|03/02/2016|||OK30|Implement a new sewing machine to process the sleeve component of the GORE TAG Thoracic Endoprosthesis.
P060040|S051|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/28/2016|02/24/2016|||OK30|Relocation of a primary supplier.
P140021|S005|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0416|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS  ANTI-HCV II TEST SYSTEM|MZO|MI|Normal 180 Day Track||N|01/29/2016|07/25/2016|||APPR|Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the Modular ANALYTICS E170 analyzer.  The device, as modified, will be marketed under the trade name Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV and is indicated for:   Elecsys Anti-HCV II Immunoassay:  Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate).  Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection.  The test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay ECLIA is intended for use on the cobas e 601 and MODULAR ANALYTICS E170 immunoassay analyzers. Elecsys PreciControl Anti-HCV:  Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCV and the Elecsys Anti-HCV II immunoassays on the cobas e 601 and the MODULAR ANALYTICS E170 immunoassay analyzers.
P000008|S037|APOLLO ENDOSURGERY INC|1120 S Capital of TX Hwy|Bldg 1, Ste 300|Austin|TX|78746||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM|LTI|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|01/29/2016|03/28/2016|||APPR|Approval of the post-approval study protocol.
P830055|S168|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|02/09/2016|05/03/2016|||APPR|Approval for changes to the Attune surgical technique (additional cautionary statements, new instruments, instrument modification, and typographical/editorial changes).
P040029|S003|Euclid Systems Corporation|2776 Towerview Rd.||Herndon|VA|20171||Lens, contact, orthokeratology, overnight|EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR|NUU|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2016|05/26/2016|||APPR|Approval of name change from JSZ Orthokeratology (oprifilconA) Contact Lenses for Overnight Wear to Euclid System Orthokeratology (oprifilcon A) Contact Lenses for Overnight Wear.
P950020|S072|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE)|NWX|CV|Normal 180 Day Track||N|01/29/2016|08/18/2016|||APPR|Approval for updates to the atherotomes, adhesive, balloon catheter platform, device packaging and the sterilization process.  The device, as modified, will be marketed under the trade name WOLVERINE Coronary Cutting Balloon (Monorail & Over-The-Wire) and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics: Discrete (<15 mm in length), or tubular (10 mm to 20 mm in length); Reference Vessel Diameter (RVD) of 2.00 mm to 4.00 mm; Readily accessible to the device; Light to moderate tortuosity of proximal vessel segment; Non-angulated lesion segment (<45 Degrees); Smooth angiographic contour; Absence of angiographically visible thrombus and/or calcification.
P110013|S060|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2016|03/04/2016|||OK30|Change to the device history recording process.
P060018|S004|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE® Cervical Disc|MJO|OR|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|01/29/2016|07/20/2016|||APPR|Approval for 1) A 7-year post-approval study to evaluate the longer term safety and effectiveness of the PRESTIGE Cervical Disc. The study will involve the investigational and control patients from the pivotal investigational device exemption (IDE) study arm, as well as the patients who received the device as part of the continued access study (CAS) arm. Data will be collected at 3 years (36 months), 5 years (60 months), and 7 years (84 months) postoperatively for all patients. At each time point, Medtronic will collect the following data: Neck Disability Index score; radiographic information; and neurological status. In addition, all adverse events, including details of the nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome reported for these patients will also be collected. Reports will be submitted annually until the completion of the study. The results of this long-term data must be reflected in the labeling (via supplement) when the post-approval study is completed, as well as any other time point deemed necessary by FDA if significant new information from this study becomes available.2)	A 5-year enhanced surveillance study of the PRESTIGE Cervical Disc to fully characterize adverse events when the device is used in a broader patient population. Medtronic will collect, analyze, and submit all adverse events and complaints received by the company for the PRESTIGE Cervical Disc, as well as information on the total number of devices shipped. The study will commence at the time of PMA approval and reports will be submitted every six months for the first two years and then annually through the fifth year.
P790007|S047|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105)|LWR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/29/2016|04/28/2016|||APPR|Approval for packaging and labeling changes for the Hancock Valved Conduit Modified Orifice (Model 105) and the Hancock Valved Conduit Low Porosity (Model 150).
P870078|S031|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|THE HANCOCK VALVE CONDUIT LOW POROSITY (MODEL 150)|DYE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|01/29/2016|04/28/2016|||APPR|Approval for packaging and labeling changes for the Hancock Valved Conduit Modified Orifice (Model 105) and the Hancock Valved Conduit Low Porosity (Model 150).
P970003|S189|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE|MUZ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2016|02/26/2016|||APPR|Approval for a labeling change to inform clinicians of modified stimulator programming parameters to enhance safety in the use of the device.
P990037|S032|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|D-STAT FLOWABLE HEMOSTAT|MGB|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|01/29/2016|02/25/2016|||APPR|Approval for labeling changes to the D-Stat Flowable Hemostat Instructions for Use.
P020004|S125|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2016|02/26/2016|||OK30|Alternative manufacturing process for the tubular sleeves in the manufacture of the GORE EXCLUDER AAA Endoprosthesis.
P030009|S083|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY RAPID EXCHANGE CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|01/29/2016|03/04/2016|||OK30|Change to the device history recording process.
P000025|S085|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|THE MED-EL C40 + COCHLEAR IMPLANT|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|02/01/2016|04/29/2016|||APPR|Approval for labeling the MED-EL C40+ cochlear implant as conditionally safe for 1.5 Tesla in magnetic resonance (MR) environments, and updating the C40+ labeling with information on radiation therapy and scuba diving for patients and professionals.
P030031|S072|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/2016|08/11/2016|||APPR|Approval for the THERMOCOOL SMARTTOUCH® SF Catheters, part numbers D-1347-XX-S and D-1348-XX-S, indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF generator, for the treatment of:1) Type I atrial flutter in patients age 18 or older; and 2) Drug refractory recurrent symptomatic paroxysmalatrial fibrillation, when used with compatible three dimensional electroanatomic mapping systems. The THERMOCOOL SMARTTOUCH® SF Navigation Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO® 3 Navigation System.
P080027|S022|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2016|02/20/2016|||OK30|Addition of a new supplier for peptides used in the manufacture of the OraQuick® HCV Rapid Antibody Test.
P930038|S079|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/01/2016|02/29/2016|||OK30|Revised inspection requirements for the carrier tube and puncture locator components of the Angio-Seal Vascular Closure Device
P030002|S038|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||LENS, INTRAOCULAR, TORIC OPTICS|CRYSTALENS ACCOMMODATING INTRAOCULAR LENS & TRULIGN TORIC INTRAOCULAR LENS|MJP|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/01/2016|07/27/2016|||APPR|Approval for labeling changes to the patient labeling and directions for use.
P010031|S527|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Viva Quad S CRT-D DTBB1Q1, DTBB1QQ, Viva Quad XT CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|02/29/2016|||OK30|Modifications to the battery header manufacturing process.
P970054|S011|DIASORIN|1951 NORTHWESTERN AVENUE||STILLWATER|MN|55082|0285|ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG|PARVOVIRUS B19 IgG ENZYME IMMUNOASSAY (V519GUS)|MYL|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/03/2016|||OK30|Modification of the conjugate optimization process.
P980016|S566|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|02/29/2016|||OK30|Modifications to the battery header manufacturing process.
P010032|S113|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON, EONC, EON MINI, PROTEGE, PROTEGE MRI IMPLANTABLE PULSE GENERATORS (IPGS)|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/03/2016|||OK30|Alternate manufacturing location for the SMT Level assemblies used in the manufacturing of the Implantable Pulse Generators (IPGs) and the external accessories for the Spinal Cord Stimulation and Deep Brain Stimulation systems.
P140009|S012|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO IMPLANTABLE PULSE GENERATORS (IPGS)|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/03/2016|||OK30|Alternate manufacturing location for the SMT Level assemblies used in the manufacturing of the Implantable Pulse Generators (IPGs) and the external accessories for the Spinal Cord Stimulation and Deep Brain Stimulation systems.
P980035|S454|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA VERSA SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/01/2016|||OK30|Implementation of routine bacterial endotoxin testing.
P010031|S528|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||BRAVA CRT-D, BRAVA QUAD CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROCETA XT CRT-D, VIVA QUAD S CRT-D, VIVA QUARD XT CRT-D||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/01/2016|||OK30|Implementation of routine bacterial endotoxin testing.
P010015|S291|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/01/2016|||OK30|Implementation of routine bacterial endotoxin testing.
P090013|S216|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|RENO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/01/2016|||OK30|Implementation of routine bacterial endotoxin testing.
P130014|S002|HYPERBRANCH MEDICAL TECHNOLOGY, INC.|800-12 Capitola Drive||Durham|NC|27713||Sealant, dural|ADHERUS AUTOSPRAY DURAL SEALANT|NQR|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/02/2016|08/02/2016|||APPR|Approval for changes in a nozzle design and packaging of the Adherus Autospray ET (Extended Tip) Dural Sealant.
P980016|S567|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, VIVA AF VR ICD, VISIA AF|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/01/2016|||OK30|Implementation of routine bacterial endotoxin testing.
P100021|S051|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT II & ENDURANT IIS STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILIAC STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/02/2016|03/03/2016|||OK30|Addition of a Delrin fixture for manufacturing of the Tapered Tip Assembly.
P100026|S042|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2016|03/04/2016|||OK30|Change to use a larger chamber for the ethylene oxide (EO) sterilization of RNS® System products at the same approved sterilization facility (Sterigenics, Salt Lake City, Utah).
P910023|S370|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT+ ELLIPSE, FORTIFY ASSURA  FAMILIES OF THE ICD DEVICES|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2016|04/21/2016|||APPR|Approval for design change to high voltage capacitors.
P040037|S089|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2016|02/18/2016|||OK30|Changes to the manufacturing equipment.
P030054|S301|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE+ QUADRA ASSURA , UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/03/2016|04/21/2016|||APPR|Approval for a design change to high voltage capacitors.
P130006|S028|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2016|02/18/2016|||OK30|Changes to the manufacturing equipment.
P980016|S568|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2016|02/29/2016|||OK30|New supplier of ceramic capacitors.
P010031|S529|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRTD DTBC1Q1, DTBC1QQ; Concerto II CRTD, D274TRK; Consulta CRT-D D204TRM, D224T||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/03/2016|02/29/2016|||OK30|New supplier of ceramic capacitors.
P040020|S060|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF MULTIFOCAL INTRAOCULAR LENS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2016|02/29/2016|||OK30|Change to a new quality control measurement system for measuring spherical aberrations for the AcrySof® Multifocal IOL Model SN6AD1 at the Cork, Ireland manufacturing site and for the AcrySof® Multifocal IOL Models SN6AD1 & MN6AD1 at the Huntington, West Virginia manufacturing site.
P090018|S031|ENVOY MEDICAL CORPORATION|5000 TOWNSHIP PARKWAY||SAINT PAUL|MN|55110||Implant, hearing, active, middle ear, totally implanted|ESTEEM|OAF|EN|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|02/04/2016|08/01/2016|||APPR|Approval for modification of the approved labeling for the Esteem to reflect the findings of the Post-Approval Study protocol.
P870076|S021|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|DISPOSABLE FALOPE-RING BAND APPLICATOR KITS|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2016|03/02/2016|||OK30|Change in supplier from Senior Operations LLC (formerly known as GA MFG Precision) to XL Precision for the manufacture of the Trocar Knife (Part No. 004556-503) and a manufacturing process change to produce a one-piece configuration Trocar Knife.
P010031|S530|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA CRT-D,BRAVA QUAD CRT-D,VIVA QUAD S CRT-D,VIVA QUAD XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CRT-D MRI AMPLIA,CRT-D MRI|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2016|04/15/2016|||APPR|Approval for minor design and manufacturing changes associated with a component on the hybrid (Telemetry M Module) used in Medtronic ICD and CRT devices.
P980016|S569|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,VISIA AF VR,VISIA AF S VR,VISIA AF MRI VR SU|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2016|04/15/2016|||APPR|Approval for minor design and manufacturing changes associated with a component on the hybrid (Telemetry M Module) used in Medtronic ICD and CRT devices.
P970003|S190|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|Stimulator, autonomic nerve, implanted (depression)|VNS THERAPY SYSTEM|MUZ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|02/04/2016|04/29/2016|||APPR|Approval for a new serial adapter cable to connect the programming computer to the programming wand.
P000013|S013|HOWMEDICA OSTEONICS CORP.|325 Corporate Drive||Mahwah|NJ|07430||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|TRIDENT CERAMIC INSERT|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2016|03/04/2016|||OK30|Upgrades to the systems at a vendor.
P890040|S008|Unilens Corp., USA|10431 72ND ST. NORTH||LARGO|FL|33777||Lenses, soft contact, extended wear|SOFT-FORM 55EW; LL-55; SOFTCON EW2|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2016|02/29/2016|||OK30|Increase to the sterilization load size to utilize more of the chamber capacity.
P150003|S005|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/04/2016|03/04/2016|||OK30|Equipment updates to the laser welding process.
P130007|S010|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Sensor, glucose, invasive|ANIMAS VIBE SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|03/02/2016|||OK30|Change in the current Animas Vibe Insulin Pump final QC/kitting process required to implement process improvements to eliminate an unnecessary parts reconciliation  process, eliminate process redundancy, and to improve overall manufacturing process efficiency.  The Animas Vibe Insulin Pump is a component of the Animas Vibe System.
P980016|S570|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|02/29/2016|||OK30|Modify the hybrid ionic contamination limit.
P030017|S246|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|03/04/2016|||OK30|Addition of a rework process for the carrier subassembly of the 32 Contact Paddle Leads.
P010031|S531|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112|||Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Concerto II CRT-D D274TRK; Consulta CRT-D D204TRM, D224||CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|02/29/2016|||OK30|Modify the hybrid ionic contamination limit.
P010015|S292|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|Consulta CRT-P C4TR01; Syncra CRT-P C2TR01|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|02/29/2016|||OK30|Modify the hybrid ionic contamination limit.
P090013|S217|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Revo MRI SureScan IPG RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|02/29/2016|||OK30|Modify the hybrid ionic contamination limit.
P980035|S455|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Advisa DR IPG A4DR01; Advisa DR MRI IPG A2DR01; Advisa SR MRI IPG A3SR01|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|02/29/2016|||OK30|Modify the hybrid ionic contamination limit.
P130009|S048|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|02/16/2016|||OK30|Implement an automated data analysis spreadsheet for use during the incoming inspection for the frame tubing.
P140031|S008|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/05/2016|02/16/2016|||OK30|Implement an automated data analysis spreadsheet for use during the incoming inspection for the frame tubing.
P140030|S001|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||STENT, ILIAC|ASTRON STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2016|03/10/2016|||OK30|Removal of a second aeration phase after ethylene oxide sterilization.
P970051|S143|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/2016|09/01/2016|||APPR|Approval for a new CochlearTM CP950 Kanso sound processor, which is an external component of both the Nucleus 24 Cochlear Implant System and the Nucleus Hybrid L24 Implant System.
P130016|S016|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/08/2016|09/01/2016|||APPR|Approval for a new CochlearTM CP950 Kanso sound processor, which is an external component of both the Nucleus 24 Cochlear Implant System and the Nucleus HybridL24 Implant System.
P110013|S061|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE MICROTRAC/RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2016|03/09/2016|||OK30|Change to the automated device history recording process.
P950029|S109|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|Reply SR, Reply DR, Esprit SR, Esprit DR|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2016|03/01/2016|||OK30|Change in the sequence of some manufacturing steps and in the temperature applied during a drying and a curing step.
N18033|S080|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|ACUVUE CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2016|03/04/2016|||OK30|Alternate supplier of blister bowl polymer.
P040045|S055|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2016|03/04/2016|||OK30|Alternate supplier of blister bowl polymer.
P010031|S532|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2016|03/08/2016|||OK30|Implementation of the following previously accepted manufacturing changes:  1) the removal of various visual inspections and re-ordering of steps in final packaging; 2) a change to the high voltage capacitor weld monitoring frequency; and 3) an update to the manufacturing execution system to FACTORYworks 9.1 and associated changes.
P980016|S571|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2016|03/08/2016|||OK30|Implementation of the following previously accepted manufacturing changes:  1) the removal of various visual inspections and re-ordering of steps in final packaging; 2) a change to the high voltage capacitor weld monitoring frequency; and 3) an update to the manufacturing execution system to FACTORYworks 9.1 and associated changes.
P100049|S016|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/08/2016|03/02/2016|||OK30|Update weld ball formation laser processing parameters at a qualified vendor.
P840001|S321|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/2016|04/21/2016|||APPR|Approval for changes made to the Model 8840 N'Vision® Clinician Programmer including replacement of PCBA components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, Physician Manual labeling changes, EMC Declaration changes, device labeling changes and packaging labeling changes.
P860004|S246|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM|LKK|HO|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/2016|04/21/2016|||APPR|Approval for changes made to the Model 8840 N'Vision® Clinician Programmer including replacement of PCBA components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, Physician Manual labeling changes, EMC Declaration changes, device labeling changes and packaging labeling changes.
P960009|S246|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/2016|04/21/2016|||APPR|Approval for changes made to the Model 8840 N'Vision® Clinician Programmer including replacement of PCBA components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, Physician Manual labeling changes, EMC Declaration changes, device labeling changes and packaging labeling changes.
P970004|S210|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/2016|04/21/2016|||APPR|Approval for changes made to the Model 8840 N'Vision® Clinician Programmer including replacement of PCBA components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, Physician Manual labeling changes, EMC Declaration changes, device labeling changes and packaging labeling changes.
P080025|S105|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/08/2016|04/21/2016|||APPR|Approval for changes made to the Model 8840 N'Vision® Clinician Programmer including replacement of PCBA components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, Physician Manual labeling changes, EMC Declaration changes, device labeling changes and packaging labeling changes.
P010019|S045|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/09/2016|03/09/2016|||OK30|Implementation of a Carton Laser Mark Inspection System.
P090031|S006|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|MONOVISC|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/10/2016|02/25/2016|||APPR|Approval for adding the following language to the Instructions for Use (IFU):  “Intra-articular injection of sodium hyaluronate preparations has occasionally been associated with allergic/anaphylactic reactions and transient hypotension, which have generally resolved spontaneously or after conservative treatment.”
P030019|S023|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|ORTHOVISC|MOZ|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/10/2016|02/25/2016|||APPR|Approval for adding the following language to the Instructions for Use (IFU):  “Intra-articular injection of sodium hyaluronate preparations has occasionally been associated with allergic/anaphylactic reactions and transient hypotension, which have generally resolved spontaneously or after conservative treatment.”
P990046|S045|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/10/2016|03/09/2016|||OK30|Relocate your graft vendor's manufacturing operations to La Ciotat, France.
P130021|S019|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/06/2016|||OK30|Additional sterilization oven for the CoreValve and Evolut R TAV sterilization process.
P020045|S074|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/10/2016|03/11/2016|||APPR|Approval of a new part number and component specifications for an internal USB memory drive to address field reports related to inadequate USB drive performance
P000025|S086|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2016|05/11/2016|||APPR|Approval for the optional protection covering accessory called the WaterWear for SONNET or OPUS 2 behind-the-ear (BTE) audio processors.
P960040|S364|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Dynagen™ Models D150, D151, D152, D153; Inogen™ Models D140, D141, D142, D143; Origen™ Models D050, D051, D052, D053 ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2016|03/09/2016|||OK30|Vertical integration of the high voltage capacitor can.
P010031|S533|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2016|04/22/2016|||APPR|Approval for a dimensional change to the connector module seal.
P840001|S322|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2016|03/10/2016|||OK30|Alternate supplier of capacitors used in the manufacture of hybrid subassemblies for Restore SCS and Activa DBS systems.
P980016|S572|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/11/2016|04/22/2016|||APPR|Approval for a dimensional change to the connector module seal.
P010012|S410|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Dynagen™ Models G150, G151, G154, G156, G158; Inogen™ Models G140, G141, G146, G148; Origen™ Models G050, G051, G056, G0|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2016|03/09/2016|||OK30|Vertical integration of the high voltage capacitor can.
P960009|S247|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2016|03/10/2016|||OK30|Alternate supplier of capacitors used in the manufacture of hybrid subassemblies for Restore SCS and Activa DBS systems.
P850079|S070|COOPERVISION, INC.|370  WOODCLIFF DRIVE|SUITE 200|FAIRPORT|NY|14450|0000|Lenses, soft contact, extended wear|HYDRASOFT (METHAFILCON B) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/09/2016|||OK30|Transfer of the frequency Xcel toric core cylinder powers -0.75, -1.25, -1.75 and -2.25D dry molding manufacturing process from Dry Line S to Dry Line 1.
P790002|S035|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, bone growth, non-invasive|BIO OSTEOGEN SYSTEM 204|LOF|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/11/2016|03/07/2016|||OK30|Qualify and approve an alternate supplier to perform the coil covering/sewing manufacturing process and for fabricating an optional accessory extremity band.
P110042|S058|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/12/2016|08/08/2016|||APPR|Approval for the Model A219 EMBLEM MRI S-ICD as well as modifications to the Model A209 EMBLEM S-ICD, Model 3401 EMBLEM S-ICD Subcutaneous Electrode, Model 4711 EMBLEM S-ICD Subcutaneous Electrode Insertion Tool, Model 2877 Programmer Software Application and Model 3200 EMBLEM S-ICD Programmer.
P900056|S152|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR(R)|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/11/2016|||OK30|Change to the catheter component inspection process.
P020025|S083|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/04/2016|||OK30|Addition of an alternate vendor for components that are utilized in electrophysiology catheters.
P920047|S089|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/04/2016|||OK30|Addition of an alternate vendor for components that are utilized in electrophysiology catheters.
P980003|S065|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED RF ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/04/2016|||OK30|Addition of an alternate vendor for components that are utilized in electrophysiology catheters.
P150019|S001|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/03/2016|||OK30|Addition of a new leak tester to the manufacturing process of the Paradigm® REAL-Time family of insulin pumps at Medtronic Puerto Rico Operations Co. (MPROC). The Paradigm REAL-Time insulin pumps are components of the Paradigm REAL-Time Revel System with Enlite Sensor.
P020025|S084|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/04/2016|||OK30|Acceptance of alternate vendor for catheter tips.
P920047|S090|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|EPT-1000 CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/04/2016|||OK30|Acceptance of alternate vendor for catheter tips.
P150019|S002|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/03/2016|||OK30|Transfer of two sub-assembly processes for the REAL-Time Revel insulin pumps from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Co. (MPROC), Juncos. The Paradigm REAL-Time Revel insulin pumps are components of the Paradigm REAL-Time Revel System with Enlite Sensor.
P840001|S323|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|03/08/2016|||OK30|Changes to test sample sizes and control limits, changes to the surface treatment and cleaning processes of metal subcomponents, and transfer of receiving and incoming inspection activities for device components to alternate facilities used in the manufacture of SCS lead kits.
P130029|S004|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|FLUENCY PLUS ENDOVASCULAR STENT GRAFT|PFV|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/12/2016|08/24/2016|||APPR|Approval for a manufacturing site located at Sterigenics Belgium Petit-Rechain S.A., Zoning Industriel de petit-Rechain, Avenue Andre Ernst 21, Petit-Rechain, Verviers, 4800, Belgium, for contract sterilization.
P110019|S081|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/17/2016|||OK30|Change to the annual stability test plan.
P010019|S046|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/14/2016|||OK30|Revision of internal procedures to harmonize the nomenclature for identifying the tooling used to manufacture approved contact lenses at the Johor and Atlanta manufacturing facilities; and development and implementation of a plan to validate and verify the fabrication of Lotrafilcon B Toric optical tools at the Johor manufacturing facility.
P000030|S001|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/14/2016|||OK30|Revision of internal procedures to harmonize the nomenclature for identifying the tooling used to manufacture approved contact lenses at the Johor and Atlanta manufacturing facilities; and development and implementation of a plan to validate and verify the fabrication of Lotrafilcon B Toric optical tools at the Johor manufacturing facility.
P990012|S026|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P910018|S018|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).|MMY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/10/2016|||OK30|Change of vendor (and manufacturing site) of brominated polycarbonate for the housing and header components in the LIPOSORBER LA-15 System’s SULFLUX KP-05.
P010054|S028|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P090007|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P090008|S017|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P090009|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P100031|S016|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P110022|S017|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P100032|S013|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P110025|S015|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P110031|S014|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P130015|S006|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P140021|S006|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0416|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/16/2016|03/16/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
P970003|S191|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/18/2016|||OK30|Addition of DuPont’s new (Transition) Tyvek for use in sterile packaging of the VNS Therapy® System products.
P150019|S003|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/16/2016|||OK30|Addition of an alternate Enlite sensor automated hybrid manufacturing line (Enlite Automation Hybrid Line). The Enlite sensor is a component of the Paradigm REAL-Time Revel System with Enlite Sensor.
P920015|S174|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC(R) TRANSVENE LEAD SYSTEM|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/16/2016|||OK30|Implementation of the following previously accepted manufacturing change: select final repackaging manufacturing activities at Medtronic’s Memphis Distribution Center in Memphis, Tennessee.
P980016|S573|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/16/2016|||OK30|Implementation of the following previously accepted manufacturing change: select final repackaging manufacturing activities at Medtronic’s Memphis Distribution Center in Memphis, Tennessee.
P150019|S004|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/16/2016|||OK30|Manufacturing change in the preparation of the Piezo component of the electronic stack assemblies within the Paradigm REAL-Time Revel insulin pumps; a new preparation fixture is being used to assemble the Piezo component. The Paradigm REAL-Time Revel insulin pump is a component of the Paradigm REAL-Time Revel System with Enlite Sensor.
P010031|S534|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/16/2016|||OK30|Implementation of the following previously accepted manufacturing change: select final repackaging manufacturing activities at Medtronic’s Memphis Distribution Center in Memphis, Tennessee.
P150019|S005|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/17/2016|||OK30|Transition of the manufacturing of the Tyvek Lids used for packaging the Enlite Sensor component from the supplier’s facility in Philadelphia to Oshkosh, Wisconsin. Additionally, the facility transition includes new manufacturing assets including a coater and die cut lid press. The Enlite Sensor is a component of the Paradigm REAL-Time Revel System with Enlite Sensor.
P150019|S006|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/17/2016|||OK30|Alternate supplier of Glucose Oxidase used in the fabrication of the Enlite Glucose Sensor. Glucose Oxidase is used in the fabrication of the Enlite Glucose Sensor that is a component of the Paradigm REAL-Time Revel System with Enlite Sensor.
P150019|S007|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2016|07/27/2016|||APPR|Approval to implement a change in the material composition of the loaner pump interior paper foam tray used for packaging the pump.
P960040|S365|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2016|05/03/2016|||APPR|Approval for an alternate capacitor to be used in the communications module.
P010012|S411|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2016|05/03/2016|||APPR|Approval for an alternate capacitor to be used in the communications module.
N970003|S186|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2016|05/03/2016|||APPR|Approval for an alternate capacitor to be used in the communications module.
P030005|S133|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/17/2016|05/03/2016|||APPR|Approval for an alternate capacitor to be used in the communications module.
P150003|S006|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/17/2016|08/17/2016|||APPR|Approval for changes to the gradient outers and manifold component of the delivery system.
P860057|S143|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/17/2016|||OK30|Relocation of the Quality Center labs and associated equipment at the Edwards, Changi, Singapore facility.
P130009|S049|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/17/2016|||OK30|Relocation of the Quality Center labs and associated equipment at the Edwards, Changi, Singapore facility.
P100034|S016|Novocure, Ltd.|P.O. BOX 589||RYE BEACH|NH|03871||Stimulator, low electric field, tumor treatment|NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT|NZK|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/17/2016|03/18/2016|||OK30|Additional servicing and repair location for the Optune System.
P860057|S144|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Add a vendor for bovine pericardial tissue.
P990046|S046|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|ATS OPEN PIVOT BILEAFLET HEART VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/10/2016|||OK30|Change to an alternate test facility and alternate test method for bacterial endotoxin testing.
P100041|S068|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE  AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Add a vendor for bovine pericardial tissue.
P110021|S055|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Add a vendor for bovine pericardial tissue.
P130009|S050|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Add a vendor for bovine pericardial tissue.
P140031|S009|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Add a vendor for bovine pericardial tissue.
P090003|S039|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Changes to the stent inspection processes
P060006|S072|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Changes to the stent inspection processes
P110010|S120|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Changes to the stent inspection processes.
P130030|S021|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Changes to the stent inspection processes.
P150003|S007|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Changes to the stent inspection processes.
P130028|S003|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/18/2016|||OK30|Introduction of an additional IPG radiofrequency communications tuning step for IPG final assemblies.
P990056|S023|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/16/2016|||OK30|Transfer the following manufacturing steps to a new building: Purification of antibodies and proteins and manufacturing of antibodies and proteins labelled with biotin or ruthenium complex. In addition, lyophilization of bulk raw materials necessary for production of Elecsys assays will be moved to another new building.
P000027|S022|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK|LTJ|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/16/2016|||OK30|Transfer the following manufacturing steps to a new building: Purification of antibodies and proteins and manufacturing of antibodies and proteins labelled with biotin or ruthenium complex. In addition, lyophilization of bulk raw materials necessary for production of Elecsys assays will be moved to another new building.
P140028|S007|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/18/2016|03/07/2016|||OK30|Update to an in-process catheter inspection.
P100047|S072|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|03/17/2016|||OK30|Automation of an existing manufacturing process via software revision for the HeartWare Ventricular Assist Device (HVAD).
P030017|S247|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|03/18/2016|||OK30|Acceptance of an alternate qualified manufacturing site at the BSN Valencia facility for the laser ablation of the multi-lumen tubes, which are used in the assembly of the Infinion and Infinion CX 16 Contact Leads of the Precision, Precision Spectra, and Precision Novi Spinal Cord Stimulation (SCS) Systems
P960016|S061|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE(R) CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|02/29/2016|||OK30|Acceptance of an automated process for Ampere Generator region configuration.
P040014|S029|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|IBI THERAPY CARDIAC ABLATION SYSTEM                    ERS/ 1500T RF GENERATOR|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|02/29/2016|||OK30|Acceptance of an automated process for Ampere Generator region configuration.
P040042|S034|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|02/29/2016|||OK30|Acceptance of an automated process for Ampere Generator region configuration.
P060019|S036|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|02/29/2016|||OK30|Acceptance of an automated process for Ampere Generator region configuration.
P110016|S029|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|02/29/2016|||OK30|Acceptance of an automated process for Ampere Generator region configuration.
P130026|S016|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|02/29/2016|||OK30|Acceptance of an automated process for Ampere Generator region configuration.
P840062|S055|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(TM)|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|03/17/2016|||OK30|Replacement of the current Wet Processing Dispersion Tanks #3 and #4, located in the 105 Morgan Lane Medical Manufacturing Suite Room 407, used to produce collagen dispersions for medical devices. Both of these tanks will be replaced by Wet Processing Dispersion Tanks #6 and #5, respectively. Both tanks are fabricated by the same vendor and according to the same specifications and drawings as the existing tank.
P810006|S070|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|03/17/2016|||OK30|Replacement of the current Wet Processing Dispersion Tanks #3 and #4, located in the 105 Morgan Lane Medical Manufacturing Suite Room 407, used to produce collagen dispersions for medical devices. Both of these tanks will be replaced by Wet Processing Dispersion Tanks #6 and #5, respectively. Both tanks are fabricated by the same vendor and according to the same specifications and drawings as the existing tank.
P850010|S069|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|03/17/2016|||OK30|Replacement of the current Wet Processing Dispersion Tanks #3 and #4, located in the 105 Morgan Lane Medical Manufacturing Suite Room 407, used to produce collagen dispersions for medical devices. Both of these tanks will be replaced by Wet Processing Dispersion Tanks #6 and #5, respectively. Both tanks are fabricated by the same vendor and according to the same specifications and drawings as the existing tank.
P130005|S011|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|03/16/2016|||OK30|Use for an additional sterilization chamber for the ViperWire component.
P820033|S010|Asahi Kasei Medical Co., Ltd.|1-105 KANDA JINBOCHO|CHIYODA-KU|TOKYO||101-8|8101|Separator for therapeutic purposes, membrane automated blood cell/plasma|PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR|MDP|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/19/2016|03/09/2016|||OK30|Implementation of a new manufacturing site for the vendor [Neat Co., Ltd.] of the GD cap component of the Plasmaflo OP-05W(A) device.
P850035|S042|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR|LOE|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|02/19/2016|03/18/2016|||APPR|Approval for the addition of the following contraindication to the labeling: “Any case where SpF Spinal Fusion Stimulators could come into contact with metallic implant components (i.e., those that contain a mixture of Titanium, Cobalt Chrome, and Stainless Steel).”
P890064|S033|QIAGEN GAITHERSBURG, INC|1201 Clopper Road||Gaithersburg|MD|20878||KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk|MAQ|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|02/19/2016|04/15/2016|||APPR|Approval for a new version of the HC2 Software Suite (version 4.4) and a new hardware model of the PC used with this software.
P120006|S023|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2016|05/05/2016|||APPR|Approval for a change in bottom material for the inner and outer pouch for the AutoInjector.
P030011|S040|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/22/2016|||OK30|Change in the heat spreader used in the Companion 2 Driver Single Board Computer (SBC).
P030011|S041|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/22/2016|||OK30|Change to replace an obsolete subcomponent, a common mode filter, on the Companion 2 Driver Main Printed Circuit Board Assembly (PCBA).
P110038|S011|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2016|04/26/2016|||APPR|Approval for a shelf life extension from 3 to 4 years.
P030011|S042|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/17/2016|||OK30|Change to add three alternate, equivalent subcomponents (one capacitor, two resistors) on the Companion 2 Driver Main Printed Circuit Board Assembly (PCBA).
P980016|S574|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/15/2016|||OK30|Updates to the post sterilization test.
P010031|S535|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/15/2016|||OK30|Updates to the post sterilization test.
P040027|S048|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS|MIR|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/22/2016|08/18/2016|||APPR|Approval for addition of GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion to the GORE® VIATORR® TIPS Endoprosthesis product line.
P110010|S121|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/23/2016|||OK30|Change to the ethylene oxide sterilization  product family processing.
P100047|S073|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/22/2016|||OK30|Modification to the approved internal process challenge device (PCD) utilized for the sterilization process verification of the HeartWare Ventricular Assist System.
P130030|S022|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/23/2016|||OK30|Change to the ethylene oxide sterilization  product family processing.
P970003|S192|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/22/2016|03/23/2016|||OK30|Removal of a solvent treatment step from the manufacture of Model 302 Leads at the Costa Rica facility.
P130026|S017|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2016|03/24/2016|||APPR|Approval for modifications to the TactiSys Quartz enclosure, guide light, chassis, and packaging.
P160006||VENTANA MEDICAL SYSTEMS, INC.|1910 EAST INNOVATION PARK DR.||TUCSON|AZ|85755||Immunohistochemistry assay, antibody, programmed death-ligand 1|VENTANA PD-L1 (SP142) Assay|PLS|PA|||Y|02/22/2016|10/18/2016|16M-3431|11/15/2016|APCB|Approval for the VENTANA PD-L1 (SP142) Assay. This device is indicated for the following: VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma and non-small cell lung cancer (NSCLC) tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity.PD-L1 expression in 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) in a non-randomized study of TECENTRIQ (atezolizumab).PD-L1 expression in 50% TC or 10% IC as detected by VENTANA PD-L1 (SP142) Assay in NSCLC may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).
P060040|S052|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/22/2016|06/17/2016|||APPR|Approval for revisions to the user interface of the HeartMate II (HM II) LVAS System Monitor.
P120010|S083|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2016|03/23/2016|||OK30|Manufacturing facility move by Medtronic’s Enlite sensor substrate supplier. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor. The sensor substrate supplier, Metrigraphics, LLC, currently manufactures the Enlite sensor substrate in Wilmington, Massachusetts and will start manufacturing at the new facility in Lowell, Massachusetts. The firm states that the current sensor substrate manufacturing facility will close at the end of lease.
P150019|S008|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2016|03/23/2016|||OK30|Manufacturing facility move by Medtronic’s Enlite sensor substrate supplier. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor. The sensor substrate supplier, Metrigraphics, LLC, currently manufactures the Enlite sensor substrate in Wilmington, Massachusetts and will start manufacturing at the new facility in Lowell, Massachusetts. The firm states that the current sensor substrate manufacturing facility will close at the end of lease.
P030017|S248|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2016|03/24/2016|||OK30|Addition of an alternate supplier of the cables used in the Infinion 16 and Infinion CX Leads for the Precision SCS systems.
P970003|S193|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2016|03/24/2016|||OK30|Support of Model 105 and Model 106 Final Generator production at Cyberonics Costa Rica facility.
P050038|S029|C.R. Bard, Inc.|160 NEW BOSTON STREET||WOBURN|MA|01801||Agent, absorbable hemostatic, non-collagen based|ARISTA AH ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2016|03/23/2016|||OK30|Including an additional component supplier.
P980044|S031|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/23/2016|03/22/2016|||OK30|Sharing the facility and equipment used to manufacture SUPARTZ FX and VISCO-3 for the purpose of manufacturing a raw material for other products.
P850064|S031|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|MODEL 204 LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|Real-Time Process|Change Design/Components/Specifications/Material|N|02/24/2016|05/24/2016|||APPR|Approval for changing the screw material in the Patient Box model 314 of the Life Pulse High Frequency Ventilator.
P020004|S126|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/24/2016|06/13/2016|||APPR|Approval for an alternate colorant to be used for components of the Gore EXCLUDER AAA Endoprosthesis SIM-PULL Delivery System.
P970051|S144|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/2016|08/23/2016|||APPR|Approval for the new MP3000 cochlear implant digital sound coding strategy.
P130016|S017|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|02/24/2016|08/23/2016|||APPR|Approval for the new MP3000 cochlear implant digital sound coding strategy.
P970003|S194|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2016|03/24/2016|||OK30|Addition of alternate weld parameters for manufacture of the Model 303 implantable lead at the Costa Rica facility.
P020012|S012|SUNEVA MEDICAL, INC.|5879 PACIFIC CENTER BLVD.||SAN DIEGO|CA|92121||Implant, dermal, for aesthetic use|ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2016|04/21/2016|||APPR|Approval for changes in the manufacturing process to remove a sampling step, split sterilization batch records, and add re-sieving steps.
P970051|S145|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2016|03/22/2016|||OK30|Addition of alternative suppliers of platinum raw materials.
P130016|S018|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2016|03/22/2016|||OK30|Addition of alternative suppliers of platinum raw materials.
P080020|S019|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2016|03/22/2016|||OK30|Sharing the facility and equipment used to manufacture Gel-One for the purpose of manufacturing a raw material for other products.
P110010|S122|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/24/2016|07/15/2016|||APPR|Approval for an alternate filter for solution filtration during two manufacturing processes.
P980035|S456|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/21/2016|||OK30|Changes to the accelerometer test system.
P010015|S293|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/21/2016|||OK30|Changes to the accelerometer test system.
P010031|S536|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Protecta CRT-D D334 TRM, Protecta CRT-D D334TRG; Protec|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/23/2016|||OK30|Alternate supplier location and manufacturing process for capacitors.
P980016|S575|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/23/2016|||OK30|Alternate supplier location and manufacturing process for capacitors.
P010015|S294|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Consulta, Syncra, Viva CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/11/2016|||OK30|Replacement of two pick and place machines with one new system used in hybrid manufacturing.
P090013|S218|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG AND PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/11/2016|||OK30|Replacement of two pick and place machines with one new system used in hybrid manufacturing.
P980035|S457|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/11/2016|||OK30|Replacement of two pick and place machines with one new system used in hybrid manufacturing.
P050019|S024|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/17/2016|||OK30|Added in-process control for the pouch manufacturing process.
P090003|S040|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/25/2016|03/17/2016|||OK30|Added in-process control for the pouch manufacturing process.
P020014|S045|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|02/25/2016|04/28/2016|||APPR|Approval for modifications to the post-approval study protocol.
P080012|S033|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM|LKK|HO|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|05/26/2016|||APPR|Approval for the addition of an alternate custom integrated circuit or also called an application specific circuit (ASIC).
P810006|S071|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|10/07/2016|||APPR|Approval for installation, operation and environmental monitoring validations for the addition of three HEPA Flow Stations in the Integra Packaging Room 304 at Integra LifeSciences, 105 Morgan Lane, Plainsboro, New Jersey.
P840062|S056|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(TM)|LPG|DE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|10/06/2016|||APPR|Approval for installation, operation and environmental monitoring validations for the addition of three HEPA Flow Stations in the Integra Packaging Room 304 at Integra LifeSciences, 105 Morgan Lane, Plainsboro, New Jersey.
P850010|S070|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE|LMF|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|10/07/2016|||APPR|Approval for the installation, operation and environmental monitoring validations for the addition of three HEPA Flow Stations in the Integra Packaging Room 304 at Integra LifeSciences, 105 Morgan Lane, Plainsboro, New Jersey.
P060040|S053|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|03/24/2016|||OK30|Qualify a second source supplier for molded parts used in the HeartMate II System.
P050006|S050|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE HELEX  SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|03/24/2016|||OK30|Add equipment for the HLC dipper process.
P150014|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|03/24/2016|||OK30|Manufacturing relocation and process change for a sourced raw material used in the COBAS® systems.
P150015|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|03/24/2016|||OK30|Manufacturing relocation and process change for a sourced raw material used in the COBAS® systems.
P010019|S047|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|03/23/2016|||OK30|Manufacturing changes to include the installation and qualification of new (i.e., replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the Batam, Indonesia production facility.
P000030|S002|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|03/23/2016|||OK30|Manufacturing changes to include the installation and qualification of new (i.e., replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the Batam, Indonesia production facility.
P000018|S047|BEST VASCULAR, INC|4350 INTERNATIONAL BOULEVARD||NORCROSS|GA|30093||Intravascular radiation delivery system|BETA-CATH (TM) SYSTEM|MOU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/26/2016|07/26/2016|||OK30|Use of a new supplier and a change to the Bacterial Endotoxin Test sampling plan.
P000025|S087|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2016|05/24/2016|||APPR|Approval for the SONNET Rechargeable Battery Kit and the SONNET Mini Battery Pack cable and adapter.
P980018|S021|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|DAKO HERCEPTEST|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2016|05/27/2016|||APPR|Approval for addition of Dako PT Link programmable water bath, PT200 for pre-treatment of tissue sections when using HercepTest for Automated Link Platforms.
P140031|S010|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|02/29/2016|08/18/2016|16M-2499|08/19/2016|APPR|Approval for the SAPIEN 3 Transcatheter Heart Valve and accessories for expanding the indication to include patients with intermediate surgical risk for aortic valve replacement.  The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >= 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
P140023|S004|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS KRAS MUTATION TEST|OWD|PA|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|02/29/2016|09/24/2016|||APPR|The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients who should not be treated with Erbitux® (cetuximab) or with Vectibix® (panitumumab) when KRAS Codon 12 or 13 mutation is detected. Safety and efficacy of Erbitux® (cetuximab) or Vectibix® (panitumumab) have not been established in patients whose tumors have Codon 61 mutation.	Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.
P980035|S458|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/23/2016|||OK30|Implementation of an in-house annealing process for titanium shield subassemblies at a second tier supplier.
P010015|S295|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/23/2016|||OK30|Implementation of an in-house annealing process for titanium shield subassemblies at a second tier supplier.
P090013|S219|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG AND PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/23/2016|||OK30|Implementation of an in-house annealing process for titanium shield subassemblies at a second tier supplier.
P010031|S537|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/23/2016|||OK30|Implementation of an in-house annealing process for titanium shield subassemblies at a second tier supplier.
P980016|S577|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/23/2016|||OK30|Implementation of an in-house annealing process for titanium shield subassemblies at a second tier supplier.
P010012|S412|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|DYNAGEN ™ CRT-D G150, G151, G154; DYNAGEN ™ X4 CRT-D G156, G158; INOGEN ™ CRT-D G140, G141; INOGEN ™ X4 CRT-D G146, G148|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/23/2016|||OK30|Alternate supplier for the battery cathode tab insulator top/bottom.
P960040|S366|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ORIGEN ™ EL ICD D050, D051, D052, D053; ORIGEN ™ MINI ICD D000, D001, D002, D003; DYNAGEN ™ EL ICD D150, D151, D152, D15|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/23/2016|||OK30|Alternate supplier for the battery cathode tab insulator top/bottom.
P840001|S324|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/30/2016|||OK30|Acceptance of a new peel test monitoring process for blister trays and new peel tester equipment for the impacted products, as well as process parameter changes and other minor process updates for the package sealing, tray cleaning, and packaging inspection processes at the Rice Creek Facility.
P050042|S033|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|AP5N-2, DEPT 09VB|ABBOTT PARK|IL|60064||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/24/2016|||OK30|Add an additional supplier purity specification for an incoming raw material used in the manufacture of the ARCHITECT Anti-HCV Assay.
P080011|S041|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A)|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|02/29/2016|03/21/2016|||OK30|Expansion of the cylinder powers available for Biofinity XR toric lenses.
P060006|S073|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/29/2016|04/19/2016|||APPR|Approval for a finishing change and vendor change for a delivery system component.
P010019|S048|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/23/2016|||OK30|Installation and qualification of a new water pre-treatment and a new USP purified water system used  in the production of USP purified water at the  Batam, Indonesia  manufacturing site.
P110019|S082|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/31/2016|||OK30|Changes to the in-process packaging verification sampling plan.
P010031|S538|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2016|08/24/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
P080006|S089|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD|OJX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2016|08/24/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
P920015|S175|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC(R) TRANSVENE LEAD SYSTEM|NVY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2016|08/24/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
P930039|S148|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568|NVN|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2016|08/24/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
P860057|S145|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/22/2016|||OK30|Additional abattoir for bovine pericardium.
P090013|S220|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG AND PACING SYSTEM|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2016|08/24/2016|||APPR|Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
P100041|S069|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE  AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/22/2016|||OK30|Additional abattoir for bovine pericardium.
P120007|S008|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV 16 18/45 GENOTYPE ASSAY|OYB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/28/2016|||OK30|Scale up of the manufacturing process for three solutions used in the Aptima HPV 16 18/45 Genotype assay.
P110021|S056|EDWARDS LIFESCIENCES LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/22/2016|||OK30|Additional abattoir for bovine pericardium.
P130009|S051|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/22/2016|||OK30|Additional abattoir for bovine pericardium.
P150005|S001|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OPEN-IRRIGATED ABLATION CATHETER|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|07/05/2016|||APPR|The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its evaluation of your premarket approval application (PMA) supplement, which requested approval for a manufacturing site located at Boston Scientific Corporation, 302 Parkway, Global Park, Heredia, Costa Rica, to manufacture the Blazer Open-Irrigated Ablation Catheter.
P140031|S011|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/22/2016|||OK30|Additional abattoir for bovine pericardium.
P890017|S018|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLOON EXPANDABLE STENT|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|09/28/2016|||APPR|Approval for a change to the packaging materials for the PALMAZ Balloon-Expandable Stent.
P150005|S002|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OPEN-IRRIGATED ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/30/2016|||OK30|Change to add three ethylene oxide sterilization chambers to the BSC Coventry Rhode Island facility.
P070026|S034|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX Ceramic Total Hip System|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/01/2016|03/23/2016|||OK30|Addition of a 2D barcode manufacturing process and equipment and addition of part identification verification steps to the manufacturing process.
P100009|S017|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP DELIVERY SYSTEM|NKM|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/01/2016|03/30/2016|||APPR|Approval to modify the deployment sequence instructions in the Instructions for Use.
P140010|S014|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2016|03/29/2016|||OK30|Transfer of the drug elution test method.
P140028|S008|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2016|03/21/2016|||OK30|Updates to the manufacturing equipment.
P000044|S034|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2016|03/30/2016|||OK30|Addition of an alternate supplier for a raw material.
P030017|S249|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/02/2016|04/01/2016|||OK30|Acceptance of an alternate qualified supplier for the Ball Grid Assemblies (BGA) that are used in the Precision Novi Implantable Pulse Generators.
P070008|S071|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2016|03/29/2016|||OK30|Changes to visual inspection criteria and incoming inspection sample size for polyurethane tubing.
P050023|S096|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2016|03/29/2016|||OK30|Changes to visual inspection criteria and incoming inspection sample size for polyurethane tubing.
P100018|S014|MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Intracranial aneurysm flow diverter|PIPELINE EMBOLIZATION DEVICE|OUT|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2016|03/31/2016|||OK30|Additional sterilization chambers for the Pipeline Embolization Device and Pipeline Flex Embolization Device.
P030004|S010|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM|MFE|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2016|03/31/2016|||OK30|Additional sterilization chambers for the Apollo Onyx Delivery Microcatheter.
P110013|S062|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE MICROTRAC/RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/03/2016|03/31/2016|||OK30|Change to the ethylene oxide sterilization monitoring process.
P840001|S325|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2016|03/31/2016|||OK30|Assembly of hybrid assemblies manufactured at Medtronic Tempe Campus using the Assembleon Pick and Place machine.
P860004|S247|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2016|03/31/2016|||OK30|Assembly of hybrid assemblies manufactured at Medtronic Tempe Campus using the Assembleon Pick and Place machine.
P980016|S578|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2016|03/30/2016|||OK30|Change in the manufacturing flow by relocating the board bake step to a different time spot in the manufacturing process.
P010031|S539|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2016|03/30/2016|||OK30|Change in the manufacturing flow by relocating the board bake step to a different time spot in the manufacturing process.
P960009|S248|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2016|03/31/2016|||OK30|Assembly of hybrid assemblies manufactured at Medtronic Tempe Campus using the Assembleon Pick and Place machine.
P970004|S211|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2016|03/31/2016|||OK30|Assembly of hybrid assemblies manufactured at Medtronic Tempe Campus using the Assembleon Pick and Place machine.
P080025|S106|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/04/2016|03/31/2016|||OK30|Assembly of hybrid assemblies manufactured at Medtronic Tempe Campus using the Assembleon Pick and Place machine.
P950009|S020|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM|MNM|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2016|04/19/2016|||APPR|Approval for a manufacturing site located at BD Diagnostics, 7 Loveton Circle, Sparks, MD 21152.
P980022|S190|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2016|04/05/2016|||OK30|Relocation of a contract manufacturing facility for printed circuit boards and board stack assemblies used in all Medtronic MiniMed Paradigm Real-Time Revel insulin pumps, Paradigm Real-Time insulin pumps, and MiniMed 530G insulin pumps. The firm is also requesting changes in the manufacturing process sequence as well as updates to mechanical drawings to add vendor name and pump models. The Paradigm Real-Time insulin pumps are a component of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and the Paradigm Real-Time Revel System with Enlite Sensor. The MiniMed 530G insulin pumps are a component of the MiniMed 530G System.
P120010|S084|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2016|04/05/2016|||OK30|Relocation of a contract manufacturing facility for printed circuit boards and board stack assemblies used in all Medtronic MiniMed Paradigm Real-Time Revel insulin pumps, Paradigm Real-Time insulin pumps, and MiniMed 530G insulin pumps. The firm is also requesting changes in the manufacturing process sequence as well as updates to mechanical drawings to add vendor name and pump models. The Paradigm Real-Time insulin pumps are a component of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and the Paradigm Real-Time Revel System with Enlite Sensor. The MiniMed 530G insulin pumps are a component of the MiniMed 530G System.
P150019|S009|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2016|04/05/2016|||OK30|Relocation of a contract manufacturing facility for printed circuit boards and board stack assemblies used in all Medtronic MiniMed Paradigm Real-Time Revel insulin pumps, Paradigm Real-Time insulin pumps, and MiniMed 530G insulin pumps. The firm is also requesting changes in the manufacturing process sequence as well as updates to mechanical drawings to add vendor name and pump models. The Paradigm Real-Time insulin pumps are a component of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and the Paradigm Real-Time Revel System with Enlite Sensor. The MiniMed 530G insulin pumps are a component of the MiniMed 530G System.
P130026|S018|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2016|03/31/2016|||OK30|Changes to a fixture used in the irrigation tubing and luer lock assembly process.
P980037|S057|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER|MCX|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2016|04/22/2016|||APPR|Approval for a dual manufacturing site located at Boston Scientific Corporation, 150 Baytech Drive, San Jose, California, for final manufacturing activities, which include incoming inspection, acceptance testing, final packaging, and labeling.
P110014|S007|DUNE MEDICAL DEVICES INC|111 SPEEN ST SUITE 101||FRAMINGHAM|MA|01701||Diagnostic low electric field|DUNE MEDICAL DEVICES MARGINPROBE SYSTEM|OEE|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/07/2016|03/30/2016|||OK30|Software (Seal Test station production software) used in the production of the Margin Probe component of the system was updated to alter the sequence in which a folder name is assigned to an electronic folder containing data from the Seal Test.
P130013|S006|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY|NGV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2016|04/05/2016|||OK30|Process improvements to the implant forming process.
P140026|S002|SILK ROAD MEDICAL, INC|735 NORTH PASTORIA AVE||SUNNYVALE|CA|94085||STENT, CAROTID|ENROUTE TRANSCAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/07/2016|07/19/2016|||APPR|Approval of the following changes to the post-approval study for the device:  editorial, protocol, exclusion changes, as well as verbage changes.
P920015|S176|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|Sprint Quattro Lead 6946M; Sprint Quattro Lead 6935, 6935M, 6944, 6947, 6947M|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2016|04/04/2016|||OK30|Removal of the use of clean benches in the high voltage sterile pack manufacturing area.
P910001|S084|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2016|04/07/2016|||OK30|Changes to the distal jacket manufacturing process.
P010003|S020|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/08/2016|04/07/2016|||OK30|Modified cartoning and labeling process.
P130021|S020|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE SYSTEM|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/08/2016|03/25/2016|||APPR|Approval for reducing the pre-implantation rinsing time for the CoreValve Evolut R Transcatheter Aortic Valve.
P100010|S053|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CRYOCATHETER SYSTEM|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|02/10/2016|03/11/2016|||APPR|Approval of a new part number and component specifications for an internal USB memory drive to address field reports related to inadequate USB drive performance.
P140030|S002|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||STENT, ILIAC|ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|04/13/2016|||OK30|Change to the cleaning process and solution during stent manufacturing.
P040020|S061|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|04/01/2016|||OK30|Use of a new Multi-piece Auto-dimensional Measurement System to conduct final dimensional inspection of the AcrySof Restor Multi-Piece intraocular lenses.
P930014|S089|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|04/01/2016|||OK30|Use of a new Multi-piece Auto-dimensional Measurement System to conduct final dimensional inspection of the AcrySof multi-piece intraocular lenses.
P110008|S005|PARADIGM SPINE, LLC|505 PARK AVENUE, 14TH  FLOOR||NEW YORK|NY|10022||Prosthesis, spinous process spacer/plate|COFLEX® INTERLAMINAR TECHNOLOGY|NQO|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|08/23/2016|||APPR|Approval for the manufacturing sites located at 6688 Dixie Highway, Bridgeport, MI 48722 for the packaging and labeling of the coflex Interlaminar Technology; 11911 Clark Street, Arcadia, CA 91006 for the laser marking, in-process cleaning, and inspection of the coflex Interlaminar Technology; and 1880 Industrial Drive, Libertyville, IL 60048 for the sterilization of the coflex Interlaminar Technology.
P120010|S085|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|04/07/2016|||OK30|Use the adhesive patches supplied for use on the automated assembly line on the manual line and to use a tool in order to facilitate this change in the  Enlite sensors assembly process at Medtronic Puerto Rico Operations Company (MPROC). The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.
P150019|S010|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|04/07/2016|||OK30|Use the adhesive patches supplied for use on the automated assembly line on the manual line and to use a tool in order to facilitate this change in the  Enlite sensors assembly process at Medtronic Puerto Rico Operations Company (MPROC). The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.
P960016|S062|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE(R) CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|03/31/2016|||OK30|Change from a semi-mechanized ring brazing station to a mechanized ring brazing station.
P040037|S090|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|04/07/2016|||OK30|Replacement of a raw material resin.
P130006|S029|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|04/07/2016|||OK30|Replacement of a raw material resin.
P150003|S008|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/09/2016|04/08/2016|||OK30|Changes to the sub-assembly trimming process.
P980053|S016|CARBON MEDICAL TECHNOLOGIES, INC.|1290 HAMMOND RD.||ST. PAUL|MN|55110|5876|AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|DURASPHERE INJECTABLE BULKING AGENT|LNM|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/09/2016|04/06/2016|||APPR|Approval for the addition of an inspection procedure for the verification of shipments to the sterilization vendor; the addition of instructions into an existing manufacturing procedure to document sealer settings on the record; the addition of instructions into an existing manufacturing procedure to record additional information and verify the total amount of sterile water used; and to revise latex labeling in line with recent FDA guidance.
P920046|S009|FEMCARE LTD.|STUART COURT, SPURSHOLT PLACE, SALISBURY RD|ROMSEY|HAMPSHIRE||SO516||Laparoscopic contraceptive tubal occlusion device|FILSHIE CLIP (MARK VI) SYSTEM|KNH|OB|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/09/2016|09/09/2016|||APPR|Approval for changing MR Conditional to 3T.
P110029|S023|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/10/2016|04/06/2016|||OK30|Relocation of manufacturing activities for the purification and production of antibodies used in final test components.
P030017|S250|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/10/2016|06/08/2016|||APPR|Approval for the addition of an alternate qualified supplier for the Coil Connector that is used in the assembly of the Precision Novi Implantable Pulse Generator.
P010019|S049|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2016|03/30/2016|||OK30|Moving the 'lens rinsing' step from after the 100% wet lens QA inspection to before the inspection.
P030027|S009|MicroPort Orthopedics Inc.|5677 AIRLINE RD||ARLINGTON|TN|38002|0000|Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMIC TRANSCEND HIP ARTICULATION|MRA|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2016|09/01/2016|||APPR|Approval for a manufacturing site located at Sterigenics US LLC, 1700 College Blvd, West Memphis, Arizona, 72301.
P140028|S009|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2016|04/12/2016|||OK30|New electropolishing equipment, cleaning equipment, and manufacturing data management system.
P830061|S127|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|Capsure Sense MRI SureScan Lead Model 4074, Capsure Sense MRI SureScan Lead Model 4574|NVN|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|||APPR|Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
P930039|S149|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSureFix MRI 4076,CapSureFix Novus MRI 5076, CapSureFix MRI SureScan 5086MRI LEAD MODELS|NVN|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|||APPR|Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
P980016|S579|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1D4,Evera MRI S DR SureScan Model DDMC3D4, Ev|LWS|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|||APPR|Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
P010031|S540|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI SureScan Model DTMB1D4, Amplia MRI Quad  SureScan Model DTMB1QQ, Compia MRI SureScan Model DTMC1D4, Compia MR|NIK|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|||APPR|Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
P090013|S221|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG AND PACING SYSTEM RVDR01|LWP|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|||APPR|Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
P920015|S177|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|Sprint Quattro Secure S MRI SureScan Lead Model 6935M, Sprint Quattro Secure MRI SureScan Lead Model 6947M|NVY|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|||APPR|Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
P080006|S090|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY MRI SuresScan Lead 4196, ATTAIN ABILITY Plus MRI SureScan Lead Model 4296, ATTAIN ABILITY Straight MRI Su|OJX|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|||APPR|Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
P150005|S003|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OPEN-IRRIGATED ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2016|04/05/2016|||OK30|Transfer of a production site for extruded components.
P150004|S001|Spinal Modulation, Inc|1135 O'BRIEN DR||MENLO PARK|CA|94025||Dorsal root ganglion stimulator for pain relief|Axium Neurostimulator System|PMP|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/11/2016|05/26/2016|||APPR|Approval of the post-approval study protocol.
P140010|S015|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|16M-2650|09/14/2016|APPR|Approval for the IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter.  The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 180 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
P020004|S127|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2016|04/07/2016|||OK30|Implementation of new extruder equipment for manufacturing the base tube component of the GORE® EXCLUDER® AAA Endoprosthesis.
P970003|S195|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2016|11/23/2016|||APPR|Approval for a manufacturing site located at Cyberonics Latam S.L.R., Edificio B49, 51 Ave 0, Zona Franca Coyol, Coyol in Alajuela, Costa Rica.
P020004|S128|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2016|04/08/2016|||OK30|Implementation of two additional catheter part numbers on an existing GORE EXCLUDER AAA Endoprosthesis SIM-PULL catheter manufacturing line in Gore’s Phoenix facility.
P020004|S129|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/11/2016|04/04/2016|||OK30|Alternative manufacturing process for the tubular sleeves in the manufacture of the GORE EXCLUDER Iliac Branch Endoprosthesis.
P020024|S043|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/12/2016|||OK30|Addition of two new ethylene oxide sterilization chambers at the approved contract sterilizer.
P000039|S054|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/12/2016|||OK30|Addition of two new ethylene oxide sterilization chambers at the approved contract sterilizer.
P040040|S027|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/12/2016|||OK30|Addition of two new ethylene oxide sterilization chambers at the approved contract sterilizer.
P110016|S030|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/12/2016|||OK30|Addition of two new ethylene oxide sterilization chambers at the approved contract sterilizer.
P960016|S063|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE(R) CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/12/2016|||OK30|Addition of two new ethylene oxide sterilization chambers at the approved contract sterilizer.
P130026|S019|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/12/2016|||OK30|Addition of two new ethylene oxide sterilization chambers at the approved contract sterilizer.
P140028|S010|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|05/11/2016|||APPR|Approval of the Boston Scientific Maple Grove site as a stent component manufacturing site for the Innova stent.
P030009|S085|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/13/2016|||OK30|Change to the sterilization monitoring process.
P910001|S085|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/14/2016|04/13/2016|||APPR|Approval for the addition of warnings to the Directions for Use (DFU) of the associated Laser Catheters included in the Laser System.
P960042|S053|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH|MFA|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/14/2016|04/13/2016|||APPR|Approval for the addition of warnings to the Directions for Use (DFU) of the associated Laser Catheters included in the Laser System.
P130028|S004|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/14/2016|06/10/2016|||APPR|Approval for the following changes to the 8- and 12-electrode lead extensions for your Algovita Spinal Cord Stimulation System:1)	Decreasing your design specifications for the maximum insertion/withdrawal force from 2.0 lbf to 1.5 lbf;2)	Revising your supplier shipping requirements for the spring system connector subassembly to have the subassembly shipped while threaded on a core pin; and 3)	Elimination of the distal end strain relief.
P080011|S042|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A)|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/05/2016|||OK30|Biofinity Line 17 to manufacture Biofinity Energys Asphere (comfilcon A) minus power lenses within the approved range.
P110010|S123|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|03/14/2016|09/09/2016|||APPR|Approval for an update to the post approval study labeling.
P040043|S083|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/06/2016|||OK30|Supplier process change for the Conformable GORE TAG Thoracic Endoprosthesis delivery system hub.
P030017|S251|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|06/07/2016|||APPR|Approval for adding an alternate qualified supplier for the Coil Connector that is used in the assembly of the Precision M1 and M8 Adaptors.
P020024|S044|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/14/2016|04/12/2016|||OK30|Change in the oven used to form the AMPLATZER Duct Occluder.
P130028|S005|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/14/2016|05/26/2016|||APPR|Approval for design changes to the Model 4500 Clinician Programmer.
P110013|S064|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE MICROTRAC/RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2016|04/14/2016|||OK30|Addition of a degasser to the spray machine currently in use for the drug spray process.
P100022|S017|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2016|04/14/2016|||OK30|Changes made by a supplier of a critical component.
P150022|S001|REX MEDICAL, L.P.|555 E. NORTH LANE SUITE 5035||CONSHOHOCKEN|PA|19428||Device, hemostasis, vascular|CLOSER VASCULAR SEALING SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/15/2016|06/10/2016|||APPR|Approval for the use of the modified Arrow sheath.
P100045|S008|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM|MOM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/15/2016|05/02/2016|||APPR|Approval for an alternate contract sterilizer site located at St Jude Medical-Sylmar, 15900 Valley View Court, Sylmar, California, 93342, to perform as an alternate ethylene oxide sterilization vendor for the CardioMEMS PA Sensor and Delivery Catheter.
P010030|S073|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2016|06/14/2016|||APPR|Approval for modifications to current software (bug fixes, improvements, background noise detection feature).
P100024|S009|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2016|04/12/2016|||OK30|Changes to the DNA propagation and purification processes.
P040005|S013|DAKO DENMARK A/S|42 PRODUKTIONSVEJ||2600 GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|DAKOCYTOMATION HER2 FISH PHARMDX KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2016|04/12/2016|||OK30|Changes to the DNA propagation and purification processes.
P130022|S005|NEVRO CORPORATION|1800 BRIDGE PARKWAY||REDWOOD CITY|CA|94065||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|03/16/2016|06/14/2016|||APPR|Approval to update the design of the charging coil to eliminate the termination wraps at the end of the charging coil.
P110019|S083|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2016|04/15/2016|||OK30|Improvement to the laser welder task sequence by adding a safety light curtain circuit.
P140031|S012|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2016|03/25/2016|||OK30|Addition of an alternate supplier for the SAPIEN 3 Transcatheter Heart Valve frame component.
P130022|S006|NEVRO CORPORATION|1800 BRIDGE PARKWAY||REDWOOD CITY|CA|94065||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2016|04/15/2016|||OK30|Process changes to the manufacture of the spinal cord stimulator system battery charger, including the addition of an adhesive to a component on the printed circuit board (PCB), minor alterations to the PCB layout to improve manufacturability, and the addition of torque wrenches to its manufacturing process.
P110019|S084|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/16/2016|04/15/2016|||OK30|Change the sampling plan for annual stability of the repackaged drug substance.
P090016|S020|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|BELOTERO BALANCE|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/11/2016|||OK30|Change to the conduct of the BDDE test assay.
P030053|S033|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/15/2016|||OK30|Update to the PROC000331 Packaging with Alloyd Heat Sealers and Tyvek Pouch to implement the use of Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices.
P990075|S036|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/15/2016|||OK30|Update to the PROC000331 Packaging with Alloyd Heat Sealers and Tyvek Pouch to implement the use of Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices.
P940015|S036|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/04/2016|||OK30|Process change to add a qualified raw material supplier for frozen sliced chicken combs used in the manufacturing process of hylan G-F20.
P010015|S296|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/08/2016|||OK30|Update to the resistance spot weld equipment used to manufacture battery assemblies.
P090013|S222|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG AND PACING SYSTEM|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/08/2016|||OK30|Update to the resistance spot weld equipment used to manufacture battery assemblies.
P130007|S011|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2016|06/16/2016|||APPR|Approval for a design change to the T1 inductor of the main board used in the Animas Vibe System.
P980035|S459|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/08/2016|||OK30|Update to the resistance spot weld equipment used to manufacture battery assemblies.
P830061|S128|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/12/2016|||OK30|Addition of a new laser welding machine.
P850089|S117|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSure SP Novus Lead 5092, 5592, 5594; CapSure Z Novus Lead 5054, 5554|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/12/2016|||OK30|Addition of a new laser welding machine.
P010031|S541|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/13/2016|||OK30|Implementation of changes to the hybrid assembly and inspection process.
P980016|S580|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/13/2016|||OK30|Implementation of changes to the hybrid assembly and inspection process.
P110016|S031|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/17/2016|04/14/2016|||OK30|Supplier manufacturing changes (facility, welding equipment, and cleaning solvent) for the catheter components of the Therapy Cool Flex and FlexAbility Ablation Catheters.
P890003|S350|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pacemaker/icd/crt non-implanted components|CareLink Programmer (Model 2090), Encore Programmer (Model 29901)|OSR|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/17/2016|04/28/2016|||APPR|Approval for software changes to the Reveal LINQ FullView Application Software.
P890003|S351|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MyCareLink Patient Monitor Model 24950|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|04/29/2016|||APPR|Approval for firmware updates to the MyCareLink Patient Monitor.
P980016|S581|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|04/29/2016|||APPR|Approval for firmware update to the MyCareLink Patient Monitor
P980035|S460|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|04/29/2016|||APPR|Approval for firmware update to the MyCareLink Patient Monitor.
P010015|S297|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|04/29/2016|||APPR|Approval for firmware update to the MyCareLink Patient Monitor.
P010031|S542|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|05/24/2016|||APPR|Approval for changes to the application software and associated labeling for ICD and CRT-D devices.
P090013|S223|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG AND PACING SYSTEM|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|04/29/2016|||APPR|Approval for firmware update to the MyCareLink Patient Monitor.
P010031|S543|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|04/29/2016|||APPR|Approval for firmware update to the MyCareLink Patient Monitor.
P890003|S352|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|SYNERGYST  II PULSE GENERATOR MODELS 7070 & 7071|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|05/24/2016|||APPR|Approval for changes to the application software and associated labeling for ICD and CRT-D devices
P120006|S024|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION ABDOMINAL STENT GRAFT SYSTEM|MIH|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2016|09/29/2016|||APPR|Approval for manufacturing sites located at Synergy Health AST, LLC, 9020 Activity Road Suite D, San Diego, California 92126 and Synergy Health AST, LLC, 3200 Lakeville Highway, Suite 120, Petaluma, California 94954, for E-Beam sterilization of the Ovation Abdominal Stent Graft System Platform.
P980016|S582|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/18/2016|05/24/2016|||APPR|Approval for changes to the application software and associated labeling for ICD and CRT-D devices.
P830055|S169|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2016|04/14/2016|||OK30|Introduction of an alternate manufacturing facility and the addition of a new Coordinate Measurement Machine.
P130009|S052|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/18/2016|04/13/2016|||OK30|Modify the method used to inspect the distance between the catheter marker bands.
P080006|S091|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|04/14/2016|||OK30|Implementation of changes to the molded ring monolithic controlled release device (MCRD) wash process.
P020036|S036|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|04/20/2016|||OK30|Supplier site change.
P120002|S012|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, SUPERFICIAL FEMORAL ARTERY|SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|04/20/2016|||OK30|Supplier site change.
P030047|S032|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CAROTID|CORDIS PRECISE NITINOL STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|04/20/2016|||OK30|Supplier site change.
P010032|S114|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|04/20/2016|||OK30|Change to the electrode manufacturing process and a replacement of 100% inspection with an AQL sampling plan for the Spinal Cord Stimulation (SCS) and Deep Brain Stimulation (DBS) leads, extensions, and adapters.
P140009|S013|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO NEUROSTIMULATION SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|04/20/2016|||OK30|Change to the electrode manufacturing process and a replacement of 100% inspection with an AQL sampling plan for the Spinal Cord Stimulation (SCS) and Deep Brain Stimulation (DBS) leads, extensions, and adapters.
P010032|S115|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/2016|10/18/2016|||APPR|Approval for a Magnetic Resonance labeling change to allow full-body MRI scans under defined conditions.
P130030|S023|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE|MAF|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|09/27/2016|||APPR|Approval to sterilize the REBEL and Blazer products with the BSC2000-2 EO Sterilization Cycle at Synergy Health Costa Rica.
P100006|S004|BIOMIMETIC THERAPEUTICS,LLC|389 Nichol Mill Ln||FRANKLIN|TN|37067||Filler, bone void, synthetic peptide|AUGMENT BONE GRAFT|NOX|OR|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|06/23/2016|||APPR|Approval for a manufacturing site located at BioMimetic Therapeutics, Inc. (BMTI), 389 Nichol Mill Lane, Franklin, Tennessee, for final kit assembly and packaging.
P150005|S004|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OPEN-IRRIGATED ABLATION CATHETER|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|09/27/2016|||APPR|Approval to sterilize the REBEL and Blazer products with the BSC2000-2 EO Sterilization Cycle at Synergy Health Costa Rica.
P140028|S011|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/21/2016|03/30/2016|||OK30|Update the existing catheter coating equipment.
P110033|S021|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLUMA XC|LMH|SU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/21/2016|09/12/2016|||APPR|Approval for the labeling for Juvederm Voluma XC has been revised as follows: 1) to include the results of the completed post-approval study; 2) to include revisions to the postmarket surveillance summary; and 3) to include minor revisions intended to harmonize the directions with those of other Juvederm products.
P140010|S016|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2016|04/19/2016|||OK30|Modifications to the annual stability protocol.
P140025|S003|VENTANA MEDICAL SYSTEMS, INC.|1910 EAST INNOVATION PARK DR.||TUCSON|AZ|85755||Immunohistochemistry assay, antibody, anaplastic lymphoma kinase|VENTANA ALK (D5F3) CDX ASSAY|PKW|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/22/2016|10/21/2016|||APPR|Approval for adding the BenchMark ULTRA instrument to the intended use and labeling for the VENTANA ALK (D5F3) CDx Assay
P960016|S064|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE(R) CARDIAC ABLATION SYSTEM|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2016|08/02/2016|||APPR|Approval to rework the catheter electrode-rings at two different time points in the manufacturing process workflow.
P110023|S018|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2016|04/20/2016|||OK30|Alternative stent laser cutting system.
P130017|S007|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/22/2016|04/20/2016|||OK30|Relocation within current facility of manual dispensing, label printing, and kitting activities.
P130005|S012|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM|MCX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/23/2016|10/26/2016|||APPR|Approval to add heat/light stabilizers to the PEBAX used to construct the Saline Sheaths of the OAD.
P130009|S053|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/23/2016|09/20/2016|||APPR|Approval of the post-approval study protocol.
P960040|S367|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2016|04/20/2016|||OK30|Changes to a fixture used in the manufacturing of electronic assembly hybrids.
P010012|S413|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2016|04/20/2016|||OK30|Changes to a fixture used in the manufacturing of electronic assembly hybrids.
P960040|S368|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2016|04/14/2016|||OK30|Update work instructions for the manufacturing inspection process to define acceptable criteria for a cosmetic defect in high voltage capacitors.
P010012|S414|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2016|04/14/2016|||OK30|Update work instructions for the manufacturing inspection process to define acceptable criteria for a cosmetic defect in high voltage capacitors.
P140017|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MVS83|MOUNDS VIEW|MN|55112||Pulmonary valve prosthesis percutaneously delivered|MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)|NPV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2016|03/25/2016|||OK30|Addition of a new laser welder in the manufacturing of the Melody Transcatheter Pulmonary Valve frame.
P140020|S006|MYRIAD GENETIC LABORATORIES|320 Wakara Way||Salt Lake City|UT|84108||Cancer-related germline gene mutation detection system|BRACANALYSIS CDX|PJG|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|03/23/2016|06/17/2016|||APPR|Approval to remove the Variant Viewer application tool from the BRACAnalysis CDx device.
P930039|S150|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSureFix Novus Lead 5076; Vitatron Crystalline|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/23/2016|04/18/2016|||OK30|Additional supplier for the electrode ring and helix assembly.
P950037|S162|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2016|05/27/2016|||APPR|Approval for programmer software PSW 1506.U/1.
P000009|S066|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PHYLAX AV ICD SYSTEM|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2016|05/27/2016|||APPR|Approval for programmer software PSW 1506.U/1.
P050023|S097|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2016|05/27/2016|||APPR|Approval for programmer software PSW 1506.U/1.
P070008|S072|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|03/24/2016|05/27/2016|||APPR|Approval for programmer software PSW 1506.U/1.
P860003|S085|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|UVAR PHOTOPHERESIS SYSTEM|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2016|04/22/2016|||OK30|Manufacturing site change for the centrifuge bowl components of the Therakos UVAR XTS Procedural Kit used in the Therakos UVAR XTS Photopheresis System.
P040043|S084|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2016|04/22/2016|||OK30|Implementation of an automated laser for use in cutting the graft of the GORE TAG Thoracic Endoprosthesis.
P020025|S085|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2016|04/08/2016|||OK30|Addition of an alternate vendor for components that are utilized in electrophysiology catheters.
P020025|S086|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/24/2016|04/19/2016|||OK30|Acceptance of an alternate vendor for the IntellaNav XP and IntellaNav MiFi XP temperature ablation catheter tips.
P100017|S015|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/20/2016|||OK30|Addition of a new purified water source and a new supplier of a raw material used in the production of bulk reagents.
P120012|S011|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/20/2016|||OK30|Addition of a new purified water source and a new supplier of a raw material used in the production of bulk reagents.
P980022|S191|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/21/2016|||OK30|Transfer of equipment used for environmental conditioning for printed circuit board assemblies from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Co. (MPROC), Juncos, PR. The circuit board assemblies are used in the Paradigm family of insulin pumps which are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Paradigm REAL-Time Revel System with Enlite Sensor, and the MiniMed 530G System.
P120010|S086|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/21/2016|||OK30|Transfer of equipment used for environmental conditioning for printed circuit board assemblies from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Co. (MPROC), Juncos, PR. The circuit board assemblies are used in the Paradigm family of insulin pumps which are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Paradigm REAL-Time Revel System with Enlite Sensor, and the MiniMed 530G System.
P010003|S021|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/27/2016|||OK30|implementation of an autotitrator for the determination of glutaraldehyde concentration and an alternate gel for SDS-PAGE testing
P150019|S011|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/21/2016|||OK30|Transfer of equipment used for environmental conditioning for printed circuit board assemblies from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Co. (MPROC), Juncos, PR. The circuit board assemblies are used in the Paradigm family of insulin pumps which are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Paradigm REAL-Time Revel System with Enlite Sensor, and the MiniMed 530G System.
P120005|S046|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/21/2016|||OK30|Qualification of additional manufacturing space for the manufacture of the G5 Mobile Transmitter.   The G5 Mobile Transmitter is a component of the G5 Mobile Continuous Glucose Monitoring System.
P120010|S087|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/21/2016|||OK30|Additional Plasma Cleaning System to increase the cleaning capacity of the Enlite components at Medtronic Puerto Rico Operations Company (MPROC). The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.
P150019|S012|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/21/2016|||OK30|Additional Plasma Cleaning System to increase the cleaning capacity of the Enlite components at Medtronic Puerto Rico Operations Company (MPROC). The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.
P010033|S028|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|04/27/2016|||OK30|Addition of a component manufacturing site.
P130024|S011|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX DRUG COATED BALLOON PTA CATHETER|ONU|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/25/2016|06/28/2016|||APPR|Approval for a labeling update to include 24 month clinical results.
P100044|S020|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL|OWO|EN|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/25/2016|08/24/2016|||APPR|Approval for a manufacturing site located at Synergy Health AST, LLC, Lakevillle Hwy, Suite 120, Petaluma, CA 94954 as a backup sterilization facility for the Propel and Propel Mini Sinus Implants.
P010014|S054|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/26/2016|||OK30|Addition of a new wax supplier.
P930038|S080|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/25/2016|||OK30|Automate the puncture locator and sheath annealing cycle verification process.
P120010|S088|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/27/2016|||OK30|Change to incorporate a step that allows the operators to wipe excess Glucose Oxidase (GOx) material from the plate during Enlite glucose sensor manufacturing. The Enlite glucose sensor is a component of the MiniMed 530G System, and the Paradigm REAL-Time REVEL System with Enlite Sensor.
P150019|S013|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/27/2016|||OK30|Change to incorporate a step that allows the operators to wipe excess Glucose Oxidase (GOx) material from the plate during Enlite glucose sensor manufacturing. The Enlite glucose sensor is a component of the MiniMed 530G System, and the Paradigm REAL-Time REVEL System with Enlite Sensor.
P130009|S054|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/06/2016|||APPR|Approval for adding a new visual inspection for the Introducer component of the Edwards Ascendra+ Introducer Sheath Set.
P050018|S021|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT SCORING BALLOON CATHETER|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/26/2016|||OK30|Change to the Limulus amebocyte lysate (LAL) bacterial endotoxin test program.
P080026|S017|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV ASSAY|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/12/2016|||OK30|Change to consolidate the current QC testing for the Amplification Reagent Kit from two stages into a single finished kit QC stage.
P100017|S016|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/12/2016|||OK30|Change to consolidate the current QC testing for the Amplification Reagent Kit from two stages into a single finished kit QC stage.
P120012|S012|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|04/12/2016|||OK30|Change to consolidate the current QC testing for the Amplification Reagent Kit from two stages into a single finished kit QC stage.
P060040|S054|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|03/28/2016|04/05/2016|||APPR|Approval for adding an informational card related to the backup battery.
P120011|S003|IDEALIMPLANT|5005 LBJ FREEWAY SUITE 900||DALLAS,|TX|75244||Prosthesis, breast, inflatable, internal, saline|IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT|FWM|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/28/2016|11/17/2016|||APPR|Approval for re-sterilization of the IDEAL IMPLANT® Saline-filled Breast Implant up to a total of 44 hours exposure time if the primary dry heat sterilization (DHS) cycle is interrupted and/or aborted
P110005|S001|IBSA INSTITUT BIOCHIMIQUE SA|VIA AL PONTE 13, CH-6903||LUGANO TICINO||6903||Acid, hyaluronic, intraarticular|Gel-Syn™|MOZ|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|03/25/2016|05/23/2016|||APPR|Approval for the addition of a needle to the Gel-Syn packaging configuration
P810002|S097|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|BILEAFLET-CENTER OPENING CARDIAC VALVE|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/29/2016|04/27/2016|||OK30|Shelf life extension of the conduit component of the SJM Masters Valved Graft.
P040021|S028|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE|LWR|CV|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|03/29/2016|08/01/2016|||APPR|Approval for a final labeling update.
P030011|S043|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)|LOZ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2016|04/27/2016|||APPR|Approval for customer notifications regarding state of charge for batteries separate from consoles in air transportation.
P010032|S116|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/30/2016|04/29/2016|||OK30|Introduction of automated test equipment to measure the pull force for the removal of a stylet from a lead.
P080003|S003|HOLOGIC, INC.|35 CROSBY DR.||BEDFORD|MA|01730||Digital breast tomosynthesis|SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|OTE|RA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|03/30/2016|07/07/2016|||APPR|Approval for the 30 projection tomosynthesis feature.
P130008|S010|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATION SYSTEM|MNQ|AN|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|03/30/2016|06/01/2016|||APPR|Approval of the following changes to the post-approval study for the device:  revisions to the protocol to increase the enrollment rate.
P150011|S003|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|PERCEVAL SUTURELESS HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/27/2016|||OK30|Addition of a new bovine pericardial tissue supplier.
P130011|S004|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|FREEDOM SOLO STENTLESS HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/27/2016|||OK30|Addition of a new bovine pericardial tissue supplier.
P060040|S055|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/28/2016|||OK30|Add a new sterilization chamber for certain components of the Thoratec HeartMate II® Ventricular Assist System.
P880086|S271|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/22/2016|||OK30|Add an alternate supplier for the IS-1 connector assembly.
P060038|S027|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/27/2016|||OK30|Addition of a new bovine pericardial tissue supplier.
P060037|S044|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/29/2016|||OK30|to discontinue redundant in-house testing of Ultra High Molecular Weight Polyethylene (UHMWPE) used in the LPS-Mobile Articular Surface components (i.e., tibial inserts) upon its receipt at Zimmer
P030031|S073|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/25/2016|||OK30|Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.
P040036|S054|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMART TOUCH UNI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/25/2016|||OK30|Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.
P990025|S048|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVI-STAR and EZ Steer Nav Bi-Directional Catheter|DRF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/25/2016|||OK30|Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.
P010068|S050|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS CATHETER, EZ Steer Nav DS Bi-Directional Catheter|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/25/2016|||OK30|Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.
P950005|S060|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Directional CatheterABLATION, Celsius Flutter Bi-Directional Catheter|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/25/2016|||OK30|Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.
P010015|S298|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/22/2016|||OK30|Add an alternate material for a manufacturing gauge tool.
P010031|S544|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/22/2016|||OK30|Add an alternate material for a manufacturing gauge tool.
P090013|S224|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Revo MRI SureScan IPG RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/22/2016|||OK30|Add an alternate material for a manufacturing gauge tool.
P980016|S583|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI ICD DDMB1D4, DDMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1; Evera XT DR ICD DDBB1D1, DDBB1D|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/22/2016|||OK30|Add an alternate material for a manufacturing gauge tool.
P980035|S461|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Versa, Sensia IPG ADDR01, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, ADSR01, ADVDD01;|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|03/31/2016|04/22/2016|||OK30|Add an alternate material for a manufacturing gauge tool.
P080020|S020|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|N|04/01/2016|09/27/2016|16M-2975|09/30/2016|APPR|Approval for Gel-One.  The device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics, e.g., acetaminophen.
P100010|S054|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|Arctic Front Advance Cardiac CryoAblation Catheters|OAE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/01/2016|05/17/2016|||APPR|Approval for modifications to the catheter blood sensor board for the Arctic Front Advance catheters (models 2AF234 & 2AF284).
P050047|S052|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/04/2016|04/29/2016|||APPR|Approval for changes to the Directions for Use and Patient Labeling including updated postmarket surveillance data as well as other changes to harmonize pertinent content across Juvederm labeling documents. Minor typographical revisions and clarifications are also included.
P910023|S371|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|Ellipse/Fortify Assura Family of ICDs|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2016|06/28/2016|||APPR|Approval for Merlin PCS Model 3330 v22.0.1 Software.
P960030|S043|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|IsoFlex 1944, 1948|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2016|04/28/2016|||OK30|Alternate supplier for the lead connector boot.
P960013|S080|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2016|04/28/2016|||OK30|Alternate supplier for the lead connector boot.
P010003|S022|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2016|05/04/2016|||OK30|Change to the frequency of the bioburden assessments from quarterly to annually for BioGlue Accessories that undergo Ethylene Oxide (EO) sterilization, a modification to the Limulus Amebocyte Lysate (LAL) test method for BioGlue to include agitation during the extraction process and change the dilution to test the BioGlue extract, and to eliminate the quarterly autoclave cycle verification and the quarterly issuance of Certificates of Completion for the autoclaves used in production and microbiology.
P030054|S302|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Quadra Assura/Unify Assura Family of CRt-Ds|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2016|06/28/2016|||APPR|Approval for Merlin PCS Model 3330 v22.0.1 Software.
P030035|S146|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ANTHEM AND FRONTIER II CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2016|06/28/2016|||APPR|Approval for Merlin PCS Model 3330 v22.0.1 Software.
P970013|S069|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse-generator, single chamber, sensor driven, implantable|MICRONY PACEMAKERS|LWO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2016|06/28/2016|||APPR|Approval for Merlin PCS Model 3330 v22.0.1 Software.
P040003|S017|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000 SYSTEM|NRZ|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2016|06/27/2016|||APPR|Approval for updates to the software to change the operating system and fix minor software defects.
P880086|S272|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2016|06/28/2016|||APPR|Approval for Merlin PCS Model 3330 v22.0.1 Software.
P110039|S005|InSightec|5 NAHUM HETH STREET||TIRAT-CARMEL||39120||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE|NRZ|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|04/04/2016|06/27/2016|||APPR|Approval for updates to the software to change the operating system and fix minor software defects.
P040044|S072|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MATRIX VASCULAR CLOSURE SYSTEM (VSG)|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/04/2016|05/04/2016|||OK30|Modify the balloon material resin of the MynxAce balloon catheter.
P130013|S007|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY|NGV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2016|05/05/2016|||OK30|Modifications to in-process microbiology testing.
P130013|S008|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE|NGV|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2016|05/03/2016|||APPR|Approval of the BSC Ireland facility.
P840001|S326|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL. AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2016|05/05/2016|||OK30|Relocation of the parts cleaning of the impacted piece parts (components) from the Medtronic Sullivan Lake (SL) facility to the Medtronic Rice Creek (RC) facility.
P860004|S248|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2016|05/05/2016|||OK30|Relocation of the parts cleaning of the impacted piece parts (components) from the Medtronic Sullivan Lake (SL) facility to the Medtronic Rice Creek (RC) facility.
P960009|S249|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRIAN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2016|05/05/2016|||OK30|Relocation of the parts cleaning of the impacted piece parts (components) from the Medtronic Sullivan Lake (SL) facility to the Medtronic Rice Creek (RC) facility.
P970004|S212|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2016|05/05/2016|||OK30|Relocation of the parts cleaning of the impacted piece parts (components) from the Medtronic Sullivan Lake (SL) facility to the Medtronic Rice Creek (RC) facility.
P080025|S107|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/05/2016|05/05/2016|||OK30|Relocation of the parts cleaning of the impacted piece parts (components) from the Medtronic Sullivan Lake (SL) facility to the Medtronic Rice Creek (RC) facility.
P150011|S004|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|PERCEVAL SUTURELESS HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2016|04/29/2016|||OK30|Changes to the incoming inspection of a component used to manufacture the device stent.
P910073|S134|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE™ G/SG with 4-SITE™ Connector Defibrillation Leads, Passive Fixation Lead Models: 0265, 0266, 0282, 0283|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2016|04/27/2016|||OK30|Implementation of a new laser weld system.
P940035|S012|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|ALERE NMP22(TM) TEST|NAH|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2016|05/06/2016|||OK30|Change in the manufacturing process of the Alere NMP22 Test, in which the manufacture of the antigens used in the manufacture of the urine calibrators and urine controls has been outsourced to a Third Party Vendor.
P000039|S055|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2016|05/04/2016|||OK30|Addition of a new laser welding system.
P020024|S045|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER MULTI-FENESTRATED SEPTAL OCCULDER (CRIBRIFORM)|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2016|05/04/2016|||OK30|Addition of a new laser welding system.
P040040|S028|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/06/2016|05/04/2016|||OK30|Addition of a new laser welding system.
P140010|S017|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/06/2016|05/05/2016|||APPR|Approval for minor changes to the Indications for Use statement and Instructions for Use document.
P130007|S012|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/07/2016|06/30/2016|||APPR|Approval for design and material changes to the Force Sensor Flex assembly and Battery Cap O-Ring used in the Animas Vibe pump.
P050028|S050|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2016|04/29/2016|||OK30|New higher capacity oven for the manufacture of a bulk component used in the COBAS® system devices.
P060030|S050|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2016|04/29/2016|||OK30|New higher capacity oven for the manufacture of a bulk component used in the COBAS® system devices.
P110037|S025|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2016|04/29/2016|||OK30|New higher capacity oven for the manufacture of a bulk component used in the COBAS® system devices.
P100020|S018|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2016|04/29/2016|||OK30|New higher capacity oven for the manufacture of a bulk component used in the COBAS® system devices.
P150014|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2016|04/29/2016|||OK30|New higher capacity oven for the manufacture of a bulk component used in the COBAS® system devices.
P150015|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/07/2016|04/29/2016|||OK30|New higher capacity oven for the manufacture of a bulk component used in the COBAS® system devices.
P140017|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MVS83|MOUNDS VIEW|MN|55112||Pulmonary valve prosthesis percutaneously delivered|MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)|NPV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2016|05/04/2016|||OK30|Add bovine tissue suppliers used to manufacture the valve.
P930014|S090|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2016|04/28/2016|||OK30|Use of an automated process for injecting the AcrySof® material into intraocular lens wafers in place of the current manual casting system.
P040020|S063|Alcon Research, Ltd.|6201 South Freeway||Fort Worth|TX|76134|2099|LENS, MULTIFOCAL INTRAOCULAR|ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2016|04/28/2016|||OK30|Use of an automated process for injecting the AcrySof® material into intraocular lens wafers in place of the current manual casting system.
P860003|S086|THERAKOS, INC.|440 ROUTE 22 EAST|SUITE 140|BRIDGEWATER|NJ|08807||System, photopheresis, extracorporeal|THERAKOS UVAR XTS Photopheresis System Procedural Kit|LNR|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2016|05/05/2016|||OK30|Manufacturing process change to the exterior printing of the Tyvek lid stock for the Therakos UVAR XTS Procedural Kit used with the Therakos UVAR XTS Photopheresis System.
P020004|S130|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2016|05/05/2016|||OK30|Use of PTFE and PTFE/FEP fibers made by an approved supplier in the manufacture of the EXCLUDER AAA Endoprosthesis and Iliac Branch Endoprosthesis.
P910018|S019|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).|MMY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2016|04/19/2016|||OK30|Implementation of a new manufacturing site for the vendor [Neat Co., Ltd.] of the GD cap component of the SULFLUX® KP-05 as part of the LIPOSORBER® LA-15 System.
P130008|S011|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II UPPER AIRWAY STIMULATOR|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2016|05/16/2016|||OK30|Transfer of cleaning process from the Medtronic Sullivan Lake, Minneapolis, MN facility (SL) to the Medtronic Rice Creek, Minneapolis, MN facility (RC).
P140013|S002|MINERVA SURGICAL|101 SAGINAW DRIVE||REDWOOD CITY|CA|94063||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MINERVA ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/08/2016|08/30/2016|||APPR|Approval for a manufacturing site located at Minnetronix, Inc., 1635 Energy Park, Saint Paul, Minnesota, as a new manufacturing facility.
P140028|S012|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/11/2016|||OK30|Addition of new manufacturing equipment and an associated process.
P150005|S005|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLANAV OPEN-IRRIGATED ABLATION CATHETER|OAD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/11/2016|07/07/2016|||APPR|Approval for design changes to incorporate a magnetic sensor into the Blazer Open Irrigated Ablation Catheter. The device, as modified, will be marketed under the trade name IntellaNav Open-Irrigated Ablation Catheter and is indicated for:  The IntellaNav™ Open-Irrigated Catheter, when used with a Maestro 4000® Radiofrequency (RF) Controller and MetriQ™ Irrigation Pump, is indicated for:1) cardiac electrophysiological mapping; 2) delivering diagnostic pacing stimuli; and 3) RF ablation of sustained or recurrent type 1 atrial flutter in patients age 18 years or older.
P010012|S415|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Dynagen, Inogen, Origen CRT-D; Dynagen, Inogen, Origen X4 CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/09/2016|||OK30|Automation of transformer component movement at final electrical test and redesign of the associated system fixtures at the supplier.
P960040|S369|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Origen, Dynagen, Inogen EL ICD; Origen, Dynagen, Inogen MINI ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/09/2016|||OK30|Automation of transformer component movement at final electrical test and redesign of the associated system fixtures at the supplier.
N18033|S081|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (etafilcon A) Brand Contact Lenses|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/06/2016|||OK30|Modification to the statistical method and procedures for product sampling of finished product release.
P040045|S056|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/06/2016|||OK30|Modification to the statistical method and procedures for product sampling of finished product release.
P060040|S056|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/11/2016|05/24/2016|||APPR|Approval for a software upgrade to the Mobile Power Unit (MPU).
P930038|S081|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/06/2016|||OK30|Move the Carrier Tube component manufacturing to the existing Puerto Rico facility and automate the Carrier Tube manufacturing process.
P130022|S007|NEVRO CORPORATION|1800 BRIDGE PARKWAY||REDWOOD CITY|CA|94065||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SENZA SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|11/18/2016|||APPR|Approval to use a larger volume of sterilization load (from 4 pallets to 10 pallets) for the ethylene oxide (EO) sterilization of Senza SCS System products.
P010015|S299|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONSULTA, SYNCRA, VIVA CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/09/2016|||OK30|Changes to the integrated circuit wafer manufacturing process.
P050050|S008|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)|NTG|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/11/2016|09/01/2016|||APPR|Approval of changes to the post-approval study protocol.
P010031|S545|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, BRAVA CRT-D, BRAVA QUAD CRT-D, COMPIA MRI CRT-D, COMPIA MRI QUAD CRT-D, CONCERT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/09/2016|||OK30|Changes to the integrated circuit wafer manufacturing process.
P980016|S584|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD, EVERA S DR ICD, EVERA S VR ICD, EVERA XT CR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA X|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/09/2016|||OK30|Changes to the integrated circuit wafer manufacturing process.
P150005|S006|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OPEN-IRRIGATED ABLATION CATHETER|OAD|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|07/05/2016|||APPR|Approval for a manufacturing site located at Availmed S.A. de C.V. Ave. Industrial 20905 Interior A,  Ciudad Industrial, C.P. 22444 Tijuana, Baja California, Mexico.
P980035|S462|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG,RELIA IPG.|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/09/2016|||OK30|Changes to the integrated circuit wafer manufacturing process.
P130017|S008|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/11/2016|05/03/2016|||OK30|Qualification of facility for receiving, inspection and storage of product components.
P130007|S013|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|05/12/2016|||OK30|Change to implement a new fixture, new set-up configuration, and a control software modification for the purpose of increasing throughput for one of the incoming inspection processes used for lot acceptance of the insulin cartridges of the Animas Vibe Insulin Pump. The Animas Vibe Insulin Pump is a component of the Animas Vibe System.
P030054|S303|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QuickFlex u and Quartet CRT leads|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|05/01/2016|||OK30|Alternate analytical testing laboratory and implementation of an identity test for monolithic controlled release devices.
P860057|S146|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|05/06/2016|||OK30|Additional bovine pericardial tissue supplier.
P950022|S092|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|Durata and Optisure HV leads|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|05/01/2016|||OK30|Alternate analytical testing laboratory and implementation of an identity test for monolithic controlled release devices.
P960030|S044|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|IsoFlex Optim LV leads|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|05/01/2016|||OK30|Alternate analytical testing laboratory and implementation of an identity test for monolithic controlled release devices.
P960013|S081|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|Tendril SDX, ST, STS and OptiSense LV leads|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|05/01/2016|||OK30|Alternate analytical testing laboratory and implementation of an identity test for monolithic controlled release devices.
P860057|S147|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|NEW BRANSON ULTRASONIC WELDER GENII|DYE|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|10/28/2016|||APPR|Approval for a new Branson Ultrasonic Welding Gen II machine at Edwards Irvine, California facility.
P130009|S055|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|05/06/2016|||OK30|Additional bovine pericardial tissue supplier.
P140031|S013|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/12/2016|05/06/2016|||OK30|Additional bovine pericardial tissue supplier.
P130028|S006|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2016|05/13/2016|||OK30|Optional replacement of a diode hand-soldering process with an automated surface mount technology process and optional replacement of an uncoated wire with a zero Ohm resistor on the printed circuit boards for the Model 4200 patient programmer charger of your Algovita Spinal Cord Stimulation system.
P110010|S124|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2016|05/10/2016|||OK30|Install an additional stent wetline and inspection equipment to the (BSC) Maple Grove facility.
P130030|S024|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2016|05/10/2016|||OK30|Install an additional stent wetline and inspection equipment to the (BSC) Maple Grove facility.
P150003|S009|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2016|05/10/2016|||OK30|Install an additional stent wetline and inspection equipment to the (BSC) Maple Grove facility.
P860004|S249|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/13/2016|05/13/2016|||OK30|Manufacturing tool change- Medtronic uses a third party vendor to manufacture sub-assembly components. The vendor would like to use a new arbor press which has press force monitoring capabilities, opposed to the current arbor press which does not have such capabilities. The force monitoring will be an internal process, and no device specifications are changed.
P890023|S025|THE COOPER COMPANIES|6150 Stoneridge Mall Road|Suite 370|Pleasanton|CA|94588||Lenses, soft contact, extended wear|Sofmed Toric Weeklies|LPM|OP|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/13/2016|09/22/2016|||APPR|Approval for the addition of a new private label brand name Sofmed Toric Weeklies.
P890003|S353|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK INSTRUMENT COMMAND LIBRARY, MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR.|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2016|04/26/2016|||APPR|Approval for minor software updates to the Instrument Command Library (ICL) Model 2691 to provide support for the Visia AF family of devices.
P980016|S585|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VISIA AF VR, VISIA AF MRI VR SURESCAN, EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, P|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2016|04/26/2016|||APPR|Approval for minor software updates to the Instrument Command Library (ICL) Model 2691 to provide support for the Visia AF family of devices.
P010031|S546|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2016|04/26/2016|||APPR|Approval for minor software updates to the Instrument Command Library (ICL) Model 2691 to provide support for the Visia AF family of devices.
P010012|S416|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/14/2016|06/09/2016|||APPR|Approval for a shelf-life extension to 18 months.
P130017|S009|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/14/2016|05/05/2016|||OK30|Qualify an alternative supplier for reagents utilized in the Cologuard assay.
P080027|S023|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2016|05/10/2016|||OK30|Relocation of the manufacturing process for an OraQuick® HCV Rapid Antibody Test component to another OraSure manufacturing facility.
P120011|S004|IDEALIMPLANT|5005 LBJ FREEWAY SUITE 900||DALLAS,|TX|75244||Prosthesis, breast, inflatable, internal, saline|IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2016|05/11/2016|||OK30|Replacement of dry heat sterilization temperature sensors from pyrobuttons to thermocouples and added digital temperature chart printout, located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, California, 92780.
P980016|S586|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI XT DR SURESCAN MODEL DDMB1D1, EVERA MRI XT VR SURESCAN MODEL DVMB1D1, EVERA MRI S DR SURESCAN MODEL DDMC3D1, E|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2016|10/12/2016|||APPR|Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
P920015|S178|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935 (DF-1), SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947 (DF-1)|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2016|10/12/2016|||APPR|Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
P890003|S354|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2016|10/12/2016|||APPR|Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
P930039|S151|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2016|10/12/2016|||APPR|Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
P090013|S225|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2016|10/12/2016|||APPR|Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
P830061|S129|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574.|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/15/2016|10/12/2016|||APPR|Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
P120011|S005|IDEALIMPLANT|5005 LBJ FREEWAY SUITE 900||DALLAS,|TX|75244||Prosthesis, breast, inflatable, internal, saline|IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2016|05/13/2016|||OK30|Manufacturing sequence change: baffle shell slitting process was moved to follow the 2-inch hole die-cutting step, instead of preceding it. The facility is located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, CA 92780.
P930038|S082|St. Jude Medical, Inc.|5050 Nathan Lane North||Plymouth|MN|55442||Device, hemostasis, vascular|ANGIO-SEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2016|05/12/2016|||OK30|Revised inspection requirements for the insertion sheath and carrier tube components of the Angio-Seal Vascular Closure device.
P920047|S091|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|Blazer II, Blazer II HTD, Blazer Prime HTD|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2016|06/23/2016|||APPR|Approval for the addition of Lake Region Medical as an alternate vendor for ring electrode part numbers 150493, 14295-001, and 90414197-01.
P980003|S066|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED RF ABLATION SYSTEM|LPB|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2016|06/23/2016|||APPR|Approval for the addition of Lake Region Medical as an alternate vendor for the ring electrode component.
P020025|S087|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2016|06/23/2016|||APPR|Approval for the addition of Lake Region Medical as an alternate vendor for the ring electrode component.
P150005|S007|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OPEN-IRRIGATED ABLATION CATHETER|OAD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/15/2016|06/23/2016|||APPR|Approval for the addition of Lake Region Medical as an alternate vendor for the ring electrode component.
P990040|S022|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DRIVE||RAYNHAM|MA|02767|0350|tissue adhesive for use in embolization of brain arteriovenous malformations|TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM|KGG|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/18/2016|06/03/2016|||APPR|Approval for modified acceptance criteria for n-BCA purity and a control limit for n-BCA dimers.
P040034|S025|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL DURAL SEALANT SYSTEM|NQR|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2016|07/15/2016|||APPR|Approval for changes to three of the polymer resins used to make the Biodome BIO-SET needless access system that is a component of the PEG (polyethylene glycol) vial.
P150003|S010|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/18/2016|||OK30|Combine pre-weighing and pre-reducing equipment.
P080013|S013|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Sealant, dural|DURASEAL EXACT SPINE SEALANT SYSTEM|NQR|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2016|07/15/2016|||APPR|Approval for changes to three of the polymer resins used to make the Biodome BIO-SET needless access system that is a component of the PEG (polyethylene glycol) vial.
P060030|S051|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.
P000012|S055|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.
P110037|S026|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.
P120019|S009|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Proposed change is to transfer tube filling device and location.
P110020|S015|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Proposed change is to transfer tube filling device and location.
P100020|S019|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.
P040043|S085|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/17/2016|||OK30|Use of PTFE fibers made by an approved supplier in the manufacture of the Conformable TAG Thoracic Endoprosthesis (CTAG Device).
P050028|S051|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.
P140023|S005|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS KRAS MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Proposed change is to transfer tube filling device and location.
P970003|S196|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/18/2016|07/13/2016|||APPR|Approval for the following device changes:  1) The Model 106 Generator’s technical requirement for Heartbeat amplitude detection is being updated to include a minimum lower threshold (i.e. Minimum alower) for each of the generators five (5) gain settings (as well as adjustments to the maximum lower threshold (i.e. alower); 2) The Universal Test System is being updated of the Model 106 Generator so that the updated firmware can be loaded onto Model 106 generators; and 3) Universal Test System (UTS) Updates and Improvements.
P980040|S068|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1-PIECE IOL, MULTIFOCAL 1-PIECE IOL, TORIC 1-PIECE IOL WITH THE TECNIS iTEC PRELOADED DELIVERY SYSTEM|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/18/2016|05/13/2016|||OK30|Addition of an alternate molding supplier for the lower and upper body components used in all TECNIS iTec Preloaded Delivery System lens models manufactured at the AMO Puerto Rico and AMO Groningen BV sites.
P040037|S091|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|Gore VIABAHN ENDOPROSTHESIS|NIP|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/18/2016|09/22/2016|||APPR|Approval for a Post-Approval study labeling update to include the final study results for the extended follow-up 25cm Viabahn Endoprosthesis study.
P130006|S030|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|04/18/2016|09/22/2016|||APPR|Approval for a Post-Approval study labeling update to include the final study results for the extended follow-up 25cm Viabahn Endoprosthesis study.
P010030|S074|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/19/2016|07/18/2016|||APPR|Approval for a larger capacity battery pack and associated modifications to the battery pack connection to the printed circuit assembly (PCA) for the WCD 4000 System.  This device is indicated for patients of all ages who are at risk for sudden cardiac arrest and either not candidates for or refuse an implantable defibrillator.
P100047|S074|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2016|05/19/2016|||OK30|New facility (same supplier) to provide the battery charger for the HeartWare Ventricular Assist System (HAVD).
P980044|S032|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2016|05/13/2016|||OK30|Modifications to existing cleanrooms in the SUPARTZ FX manufacturing facility.
P980023|S074|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|Drug-Eluting Permanent Defibrillator Electrodes, Accessories to Implantable Pacemaker Pulse Generator|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|12/23/2015|05/02/2016|||APPR|Approval for full body scanning of the ProMRI CRT-D System.
P150003|S011|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/19/2016|05/31/2016|||APPR|Approve Galway, Ireland as a stent manufacturing site for synergy.
P100017|S017|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV ASSAY, ABBOTT REALTIME HCV CALIBRATOR KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT MSAMPLE PREPARATI|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2016|06/10/2016|||OK30|Relocation of manufacturing activities for the production of bulk reagents used for the Abbott mSample Preparation System.
P120012|S013|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/20/2016|06/10/2016|||OK30|Relocation of manufacturing activities for the production of bulk reagents used for the Abbott mSample Preparation System.
P910018|S020|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER® LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/20/2016|09/23/2016|||APPR|Approval for a modification of the indications for use of the system.
P960016|S065|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE(R) TC CARDIAC ABLATION SYSTEM|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/21/2016|05/19/2016|||OK30|Acceptance of modified manufacturing criteria and removal of in-process inspection step for the anchor sleeve assembly component.
P070009|S016|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band|LTI|GU|Normal 180 Day Track No User Fee|Labeling Change - Indications/instructions/shelf life/tradename|N|04/21/2016|05/16/2016|||APPR|Approval for the trade name changes from REALIZE Adjustable Gastric Band-C with Injection Port and Applier to Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier, and REALIZE Injection Port and Applier to Ethicon Endo-Surgery Gastric Band Sutureless Port and Applier.
P910077|S152|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|LATITUDE NXT RELEASE 4.1.1|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2016|07/08/2016|||APPR|Approval for LATITUDE NXT Patient Management System, Release 4.1.1.
P960040|S370|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ICD DEVICES: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, OPRIGEN, INOGEN, DYNAGEN, AUTOGEN.|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2016|07/08/2016|||APPR|Approval for LATITUDE NXT Patient Management System, Release 4.1.1.
P010012|S417|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT-D RESYNCHRONIZATION DEVICES, COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2016|07/08/2016|||APPR|Approval for LATITUDE NXT Patient Management System, Release 4.1.1.
P030005|S134|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CRT-P RESYNCHRONIZATION DEVICES: INVIVE, INTUA, VISIONIST, VALITUDE|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2016|07/08/2016|||APPR|Approval for LATITUDE NXT Patient Management System, Release 4.1.1.
P110042|S059|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS ICD DEVICES: EMBLEM.|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2016|07/08/2016|||APPR|Approval for LATITUDE NXT Patient Management System, Release 4.1.1.
N970003|S187|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PACEMAKER DEVICES. ADVANTION, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA AND ALTRUA 2 SUPPORTED|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2016|07/08/2016|||APPR|Approval for LATITUDE NXT Patient Management System, Release 4.1.1.
P130007|S014|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/21/2016|07/06/2016|||APPR|Approval for a change to the solder composition for three subassemblies used in the Animas Vibe pump as required for RoHS compliance. The Animas Vibe pump is a component of the Animas Vibe System.
P010019|S050|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; AIR OPTIX PLUS HYDRAGLYDE MULTIFOCAL; AIR OPTIX PL|LPM|OP|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/22/2016|07/19/2016|||APPR|Approval for the addition of 0.04% (400ppm) polyoxyethylene-poluoxybutylene copolymer (EO45BO10) to the package saline for lotrafilcon B silicone hydrogel soft contact lenses for extended wear.
P070026|S035|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2016|05/17/2016|||OK30|Addition of a laser marking machine to the manufacturing process.
P060040|S057|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/22/2016|05/24/2016|||APPR|Approval for revisions to the Pocket Controller Primary Application software and the Liquid Crystal Display (LCD) Application software.
P110010|S125|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2016|05/20/2016|||OK30|Update to the software on the automated catheter manufacturing line.
P150003|S012|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2016|05/20/2016|||OK30|Update to the software on the automated catheter manufacturing line.
P130008|S012|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE PROGRAMMER SYSTEM|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/22/2016|05/20/2016|||OK30|Change to replace the machined housing with a new injection molded housing for the Model 2740 Inspire Programmer System (IPS) telemetry module box.
P140031|S015|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|04/22/2016|08/19/2016|||APPR|Approval for various changes to the post-approval study protocol for the continued follow-up of the IDE High Risk Patients Cohort.
P840064|S061|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2016|05/18/2016|||OK30|Implementation of changes made to the depyrogenation process for the ophthalmic viscoelastic devices.
P890047|S047|Alcon Research, Ltd.|6201 SOUTH FREEWAY, R3-48||FORT WORTH|TX|76134|2099|AID, SURGICAL, VISCOELASTIC|PROVISC OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2016|05/18/2016|||OK30|Implementation of changes made to the depyrogenation process for the ophthalmic viscoelastic devices.
P990023|S014|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (OVD)|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2016|05/18/2016|||OK30|Implementation of changes made to the depyrogenation process for the ophthalmic viscoelastic devices.
P100042|S010|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2016|05/20/2016|||OK30|Addition of a new manufacturing site, scale-up, cleaning process, and automated filling for reagent production.
P980035|S463|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2016|05/23/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P900056|S153|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|Rotablator Rotational Atherectomy System (ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER)|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2016|05/25/2016|||OK30|Change to the wireClip Torquer sub-assembly process.
P140017|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MVS83|MOUNDS VIEW|MN|55112||Pulmonary valve prosthesis percutaneously delivered|ENSEMBLE II TRANSCATHETER VALVE DELIVERY SYSTEM|NPV|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/25/2016|09/12/2016|||APPR|Approval for a product line extension to the Ensemble Transcatheter Valve Delivery System.
P110013|S068|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE MICROTRAC/RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2016|05/25/2016|||OK30|Extension of the Laboratory Information Management System (LIMS) capabilities.
P000037|S045|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/25/2016|05/31/2016|||OK30|the addition of a new piece of test equipment used in the manufacture of heart valve subassemblies
P110004|S017|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM)|MAF|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|04/26/2016|06/24/2016|||APPR|Approval of the following changes to the post-approval study for the device:  revisions to the exclusion criteria and clarification of the serious adverse event definition.
P910023|S372|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICD'S|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2016|07/25/2016|||APPR|Approval for software modifications to the Merlin.net MN6000 HF Web Application v9.0 software.
P030054|S304|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2016|07/25/2016|||APPR|Approval for software modifications to the Merlin.net MN6000 HF Web Application v9.0 software.
P030035|S147|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S|NKE|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2016|07/25/2016|||APPR|Approval for software modifications to the Merlin.net MN6000 HF Web Application v9.0 software.
P880086|S273|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable pulse generator, pacemaker (non-CRT)|ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2016|07/25/2016|||APPR|Approval for software modifications to the Merlin.net MN6000 HF Web Application v9.0 software.
P100045|S009|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF SYSTEM|MOM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2016|07/25/2016|||APPR|Approval for software modifications to the Merlin.net MN6000 HF Web Application v9.0 software.
P010015|S300|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2016|05/24/2016|||OK30|Modification to the visual inspection of welded brackets.
P060040|S058|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM|DSQ|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/26/2016|10/05/2016|||APPR|Approval for a relocation of a supplier.
P120005|S047|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE  RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|04/26/2016|07/08/2016|||APPR|Approval for the replacement of the receiver speaker component of the Dexcom G4 PLATINUM/G5 Mobile. Together with the proposed component change, the supplement requested approval of changes to the speaker installation method. The proposed changes occur at Dexcom Inc. as well as OnCore Manufacturing Services, Dexcoms approved supplier. The receiver is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring Systems.
P840001|S327|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2016|05/27/2016|||OK30|Updated software inspection in the distribution center facility to test the batteries of implantable neurostimulators returned from the field prior to restocking.
N970003|S188|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO, INGENIO, VITALIO, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2016|05/25/2016|||OK30|Additional leak tester to the battery manufacturing line.
P010012|S418|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DYNAGEN CRT-D: G150, G151, G154, X4 CRT-D; G156, G158 INOGEN|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2016|05/17/2016|||OK30|Implementation of an automated optical inspection of components on device printed circuit boards.
P960009|S250|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2016|05/27/2016|||OK30|Updated software inspection in the distribution center facility to test the batteries of implantable neurostimulators returned from the field prior to restocking.
P150012|S001|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO VALITUDE MRI, PROPONENT VALITUDE MRI, ACCOLADE VALITUDE MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2016|05/25/2016|||OK30|Additional leak tester to the battery manufacturing line.
P960040|S371|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ORIGEN EL ICD: D050, D051, D052, D053 INOGEN EL ICD: D140, D141, D142,|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2016|05/17/2016|||OK30|Implementation of an automated optical inspection of components on device printed circuit boards.
P030005|S135|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE, VALITUDE X4, INVIVE, INTUA|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2016|05/25/2016|||OK30|Additional leak tester to the battery manufacturing line.
P890055|S062|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP.|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/27/2016|05/27/2016|||OK30|Change for a new packaging equipment to seal the pouches for the Codman 3000 Constant-Flow Implantable Infusion Pump O.R. Prep Kit Tubing Assembly.  External supplier, Command Medical Products (Command), has requested implementation of new packaging sealing equipment, a Sencorp bar sealer (12-PL/2) with a removable work surface.  The supplier has requested the change as a process improvement.
P990023|S015|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2016|07/26/2016|||APPR|Approval for a lower endotoxin specification.
P010031|S547|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|AMPLIA MRI, AMPLIA MRI QUAD, BRAVA, BRAVA QUAD, COMPIA MRI,COMPIA MRI QUAD, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2016|06/16/2016|||APPR|Approval for modifications to the Telemetry M Module.
P980016|S587|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI, EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR, VISIA AF MRI VR, VISIA AF VR ICD.|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2016|06/16/2016|||APPR|Approval for modifications to the Telemetry M Module.
P890003|S355|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MyCareLink Patient Monitor 24950|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|04/28/2016|06/16/2016|||APPR|Approval for modifications to the Telemetry M Module.
P010032|S117|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitr|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2016|05/27/2016|||OK30|Addition of an alternate supplier of inner tubing and addition of isopropyl alcohol to aid in the assembly of SCS and DBS leads.
P140009|S014|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DBS Extensions|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2016|05/27/2016|||OK30|Addition of an alternate supplier of inner tubing and addition of isopropyl alcohol to aid in the assembly of SCS and DBS leads.
P960043|S092|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/28/2016|05/28/2016|||OK30|Modification to the needle retention force specification.
P130015|S007|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG|LOM|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|04/28/2016|10/24/2016|||APPR|Approval for the migration of the Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg to the cobas e 602 immunoassay analyzer.
P110043|S010|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2016|05/27/2016|||OK30|Alternate sampling plan for process monitoring.
P130001|S001|EPIGENOMICS AG|GENESTSTR.5||BERLIN||||System, colorectal neoplasia, DNA methylation and hemoglobin detection|Epi proColon|PHP|PA|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2016|11/18/2016|||APPR|Approval for a manufacturing site located at Sentinel CH. SpA, Via Robert Koch, 2, 20152, Milan, Italy
P130028|S007|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2016|06/08/2016|||OK30|Changes to the workflow for the Clinician Programmer Printed Circuit Board manufacturing process.
P980016|S588|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2016|05/25/2016|||OK30|Change to the supplier's cleaning process for the accelerometer.
P010031|S548|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Brava Quad CRT-D DTBC|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2016|05/25/2016|||OK30|Change to the supplier's cleaning process for the accelerometer.
P100049|S017|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2016|05/19/2016|||OK30|Process change is for gross leak hermeticity testing.
P150033|S001|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM|PNJ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2016|05/25/2016|||OK30|Change to the supplier's cleaning process for the accelerometer.
P140028|S013|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|04/29/2016|05/27/2016|||OK30|Updates to the manufacturing process.
P130024|S012|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX DRUG COATED BALLOON PTA CATHETER|ONU|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|04/29/2016|05/05/2016|||APPR|Approval for minor changes to the Indications for Use statement and Instructions for Use document.
P100026|S043|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|04/29/2016|07/28/2016|||APPR|Approval for changes on the design of the Wand, which is used for communication between the Neurostimulator and the Remote Monitor, and the Neurostimulator and the Programmer.
P020036|S037|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, ILIAC|S.M.A.R.T. CONTROL NITINOL STENT SYSTEM|NIO|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/02/2016|06/09/2016|||APPR|Approval for changes to the MR labeling.
P130007|S015|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2016|06/01/2016|||OK30|Change to transfer the complaint return and investigation operations for the Dexcom G4 Platinum Sensors from the Dexcom facility in San Diego, California, to the Animas facility in West Chester, Pennsylvania.  The Dexcom G4 Platinum Sensors are a component of the Animas Vibe System.
P050047|S053|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM Hyaluronate Gel Implants|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2016|05/26/2016|||OK30|Authorization for the implementation of new equipment for scale-up of Juvederm manufacturing processes.
P130009|S057|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Panel Track|Labeling Change - Indications/instructions/shelf life/tradename|Y|05/02/2016|08/18/2016|16M-2498|08/19/2016|APPR|Approval for the Edwards SAPIEN XT Transcatheter Heart Valve and accessories for expanding the indication to include patients with intermediate surgical risk for aortic valve replacement. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality >= 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
P130022|S008|NEVRO CORPORATION|1800 BRIDGE PARKWAY||REDWOOD CITY|CA|94065||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SENZA SPINAL CORD STIMULATION (SCS) SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/02/2016|07/14/2016|||APPR|Approval for software changes to the Clinician Programmer Model PG2000.
P980043|S053|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2016|06/01/2016|||OK30|Modification of the stent machining process.
P990064|S062|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2016|06/01/2016|||OK30|Modification of the stent machining process.
P150012|S002|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/02/2016|05/31/2016|||OK30|Implementation of the following previously accepted manufacturing changes: 1) Removal of a plating process on the crystal oscillator component; 2) modifications to the crystal oscillator manufacturing process; 3) addition of an alternate supplier of a battery raw material; 4) addition of an alternate supplier of the power conductor component; 5) addition of an alternate supplier of the telemetry coils; 6) addition of an alternate supplier of capacitors; 7) addition of an automated visual inspection system for coil springs; 8) addition of an automated packaging line; and 9) vertical integration of the spring connector housing block.
P140028|S014|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2016|06/01/2016|||OK30|Supplier site change.
P980016|S589|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI, S DR ,S VR, XT DR , XT VR ICD'S; MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2016|05/25/2016|||OK30|Changes to the wafer manufacturing process.
P010031|S549|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|AMPLIA MRI CRT-D; QUAD CRT-D; BRAVA CRT-D; BRAVA QUAD CRT-D; COMPIA MRI CRT-D; QUAD CRT-D; CONCERTO, CONSULTA, MAXIMO II|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2016|05/25/2016|||OK30|Changes to the wafer manufacturing process.
P970003|S197|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators.|LYJ|NE|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/03/2016|07/28/2016|||APPR|Approval for changes to the labeling to update stimulation dosing strategies and modify ECG filter settings.
P080006|S092|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196,4296,4396 LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2016|06/01/2016|||OK30|Addition of a new crimper system used to crimp proximal connector components.
P060037|S045|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2016|06/01/2016|||OK30|Alternative belt dressing for metal finishing and polishing applications for the NexGen® LPS-Flex/LPS Mobile Bearing Knee System components.
P910056|S022|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ENVISTA HYDROPHOBIC INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2016|05/27/2016|||OK30|Addition of an alternate dose audit study facility for the en Vista® Hydrophobic Acrylic Intraocular Lens (IOL).
P040008|S013|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|VIDAS TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/03/2016|05/31/2016|||OK30|Change of subcontractor of mouse ascite.
P010031|S550|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CLARIA MRI CRT-D SURESCAN MODEL DTMA1D4; QUAD MODEL DTMA1QQ; MODEL DTMA1D1, MODEL DTMBIQ1, MODEL DTMB1Q1,MODEL DTMC1D1,|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2016|10/25/2016|||APPR|Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
P080006|S093|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD; ATTAIN ABILITY PLUS MRI SURESCAN LEAD MODEL 4296; ATTAIN ABILITY STRAIGHT MRI|OJX|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2016|10/25/2016|||APPR|Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
P920015|S179|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M & 6935; SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947M & 6947|NVY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2016|10/25/2016|||APPR|Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
P930039|S152|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2016|10/25/2016|||APPR|Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
P090013|S226|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2016|10/25/2016|||APPR|Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
P830061|S130|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574|NVN|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2016|10/25/2016|||APPR|Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
P890003|S356|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CARELINK MONITOR MODEL 2490C, MODEL 24950; CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MODEL 2491 DD|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/03/2016|10/25/2016|||APPR|Approval for the Claria MRI/Claria MRI Quad CRT-D SureScan devices as well as the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI CRT-D SureScan device models with DF-1 connector compatibility.
P020018|S056|COOK, INC.|750 Daniels Way|P.O. Box 489|Bloomington|IN|47402||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM|MIH|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2016|06/03/2016|||APPR|Approval to change the in-process sampling for endotoxin testing.
P960040|S372|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). ORIGEN , INOGEN, DYNAGEN EL ICD'S. NG2.5 IMPLANTABLE CARDIOVERTER DEFIB|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2016|05/25/2016|||OK30|Addition of a new acrylic dispense system in the pulse generator header manufacturing process.
P010012|S419|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2016|05/25/2016|||OK30|Addition of a new acrylic dispense system in the pulse generator header manufacturing process.
N970003|S189|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGENIO 2 PACEMAKERS. ALTRUA 2 , ESSENTIO, PROPONENT, ACCOLADE.  IMPLANTABLE PULSE GENERATOR (PG), ADVANTIO, INGENIO, VI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2016|05/25/2016|||OK30|Addition of a new acrylic dispense system in the pulse generator header manufacturing process.
P030005|S136|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|CARDIAC RESYNCHRONIZATION THERAPY- PACEMAKER (CRT-P); INVIVE AND INTUA MODELS. INGENIO 2.  VALITUDE MODEL U125 ; VALITUD|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2016|05/25/2016|||OK30|Addition of a new acrylic dispense system in the pulse generator header manufacturing process.
P150012|S003|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PACEMAKER MODELS. ESSENTIO , PROPONENT, ACCOLADE MRI'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/04/2016|05/25/2016|||OK30|Addition of a new acrylic dispense system in the pulse generator header manufacturing process.
P830055|S170|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2016|06/03/2016|||OK30|Addition of part identification and traceability components throughout the manufacturing process.
N970012|S115|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESES (IPP)|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2016|05/31/2016|||OK30|Modifications to the injection mold for the Quick Connect Collet.
P000053|S063|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM (AUS)|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2016|05/31/2016|||OK30|Modifications to the injection mold for the Quick Connect Collet.
P090006|S017|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM - ILLIAC|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2016|06/01/2016|||OK30|Changes to the stent manufacturing process.
P110040|S009|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|COMPLETE SE VASCULAR STENT SYSTEM - SFA AND PPA|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/05/2016|06/01/2016|||OK30|Changes to the stent manufacturing process.
P890003|S357|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR SYSTEM|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/06/2016|07/08/2016|||APPR|Approval for software updates to the CareLink Network DDMA Model 2491.
P150033|S002|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|MICRA|PNJ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/06/2016|07/08/2016|||APPR|Approval for software updates to the CareLink Network DDMA Model 2491.
P970031|S052|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2016|05/31/2016|||OK30|Addition of three new tissue suppliers.
P990064|S063|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHETIC|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2016|05/31/2016|||OK30|Addition of three new tissue suppliers.
P980043|S054|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2016|05/31/2016|||OK30|Addition of three new tissue suppliers.
P870078|S032|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOW POROSITY VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2016|05/31/2016|||OK30|Addition of three new tissue suppliers.
P790007|S048|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/06/2016|05/31/2016|||OK30|Addition of three new tissue suppliers.
P120005|S048|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G5 Mobile Continuous Glucose Monitoring System|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|05/06/2016|08/02/2016|||APPR|Approval for firmware changes to the Dexcom G5 Mobile Receiver to decrease occurrence of certain recoverable errors requiring a system reset.  In addition, the firmware changes address customer complaints related to the recoverable errors.  The Dexcom G5 Mobile Receiver is a component of the Dexcom G5® Mobile Continuous Glucose Monitoring System.
P150012|S004|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGENIO 2 MRI PACEMAKERS.|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/06/2016|07/14/2016|||APPR|Approval for design changes to the accelerometer component and associated changes.
P970003|S199|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|PULSE MODEL 102, DEMIPULSE MODEL 103, ASPIREHC MODEL 105, ASPIRESR MODEL 106 GENERATOR.|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2016|06/08/2016|||OK30|Use of a new resistance welder during the spot welding of anchor tabs onto Model 102, 103, 105 and 106 generator-cans of the VNS Therapy Systems.
P040038|S031|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, CAROTID|XACT CAROTID STENT SYSTEM|NIM|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2016|07/13/2016|||APPR|Approval for a manufacturing site located at Sterigenics Costa Rica.
P120020|S013|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2016|07/13/2016|||APPR|Approval for a manufacturing site located at Sterigenics Costa Rica.
P990071|S033|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|SMARTABLATE SYSTEM: SMARTABLATE RF GENERATOR AND REMOTE CONTROL, SMARTABLATE SYSTEM: SMARTABLATE IRRIGATION PUMP|LPB|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|05/09/2016|08/04/2016|||APPR|Approval to implement hardware and software updates to the SmartAblate System - RF Generator and Remote Control and Irrigation Pump.
P060011|S009|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7||intraocular lens|C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/09/2016|06/08/2016|||OK30|Introduction of a new standard blister pouch for the Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses.
P040003|S018|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE 2000 SYSTEM|NRZ|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2016|08/26/2016|||APPR|Approval for change to the ExAblate system to comply with the European directive 2002/95/EC and 2011/65/EU in relation to Restriction of Hazardous Substance (RoHS).
P110039|S006|InSightec|5 NAHUM HETH STREET||TIRAT-CARMEL||39120||Ablation system, high intensity focused ultrasound (hifu), mr-guided|EXABLATE|NRZ|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2016|08/26/2016|||APPR|Approval for change to the ExAblate system to comply with the European directive 2002/95/EC and 2011/65/EU in relation to Restriction of Hazardous Substance (RoHS).
P990038|S021|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2016|06/08/2016|||OK30|Removal of an in-process washing step for a raw material and replacement with additional supplier and manufacturing controls.
P990041|S020|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285||ETI-AB-EBK PLUS ASSAY||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2016|06/08/2016|||OK30|Removal of an in-process washing step for a raw material and replacement with additional supplier and manufacturing controls.
P990042|S017|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ETI-AB-AUK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2016|06/08/2016|||OK30|Removal of an in-process washing step for a raw material and replacement with additional supplier and manufacturing controls.
P990043|S021|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|DIASORIN ETI-EBK PLUS ASSAY|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2016|06/08/2016|||OK30|Removal of an in-process washing step for a raw material and replacement with additional supplier and manufacturing controls.
P990044|S018|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285||ETI-CORE-IGMK PLUS ASSAY||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2016|06/08/2016|||OK30|Removal of an in-process washing step for a raw material and replacement with additional supplier and manufacturing controls.
P990045|S018|DIASORIN, INC.|1951 NORTHWESTERN AVE.||STILLWATER|MN|55082|0285||ETI-AB-COREK PLUS ASSAY||MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2016|06/08/2016|||OK30|Removal of an in-process washing step for a raw material and replacement with additional supplier and manufacturing controls.
P150003|S013|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (Monorail)|NIQ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/10/2016|06/17/2016|||APPR|Approval for a change to the stent protector, carrier tube clip, and addition of a graphic insert to the packaging.
P130001|S002|EPIGENOMICS AG|GENESTSTR.5||BERLIN||||System, colorectal neoplasia, DNA methylation and hemoglobin detection|Epi proColon|PHP|PA|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|05/10/2016|10/18/2016|||APPR|Approval of the post-approval study protocol.
P020004|S131|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|EXCLUDER BIFURCATED AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/10/2016|06/08/2016|||OK30|Change in the radial placement of the catheter torque bump on the GORE® EXCLUDER® AAA Endoprosthesis SIM-PULL catheter.
P100009|S018|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP  CLIP DELIVERY SYSTEM|NKM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/2016|08/09/2016|||APPR|Approval for a design change to the Actuator Slider component of the delivery system.
P980016|S590|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI ICD, VISTA AF MRI VR ICD, VISIA AF VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2016|06/07/2016|||OK30|Updates to the post sterilization test.
P010031|S551|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, COMPIA MRI CRT-D,COMPIA MRI QUAD CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2016|06/07/2016|||OK30|Updates to the post sterilization test.
P020025|S088|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|INTELLATIP MIFI XP TEMPERATURE ABLATION SYSTEM|OAD|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/2016|07/07/2016|||APPR|Approval for a design change to the thermistor wire insulating material.
P130026|S020|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/11/2016|06/06/2016|||OK30|Changes to electrical tests performed during the TactiCath Quartz manufacturing process.
P920047|S092|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/11/2016|07/07/2016|||APPR|Approval for a design change to the thermistor wire insulating material.
P050023|S098|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|CARDIOMESSENGER SMART|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/12/2016|06/08/2016|||APPR|Approval for a minor firmware update.
P970004|S213|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (Urinary)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2016|06/07/2016|||OK30|Changes related to the under bump metallization (UBM) for the telemetry M module subcomponent of the impacted external device (model 3537).
P950020|S073|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|FLEXTOME CUTTING BALLOON MICROSURGICAL DILITATION DEVICE|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2016|06/09/2016|||OK30|Implement changes to the balloon protector component manufacturing of the subject device.
P080025|S108|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (Bowel)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2016|06/07/2016|||OK30|Changes related to the under bump metallization (UBM) for the telemetry M module subcomponent of the impacted external device (model 3537).
P110013|S069|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE MICROTRAC/RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/12/2016|06/10/2016|||OK30|Introduction of an optional chemical treatment into the manufacturing process for chloroform used in the drug/polymer coating process of the Resolute Integrity stents at Medtronic Ireland.
P010030|S075|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2016|06/06/2016|||OK30|Specification of a temperature controlled heat gun to be used in the LifeVest 4000 Electrode Belt Subassembly procedure.
P130005|S013|CARDIOVASCULAR SYSTEMS, INC.|651 CAMPUS DR||MINNEAPOLIS|MN|55211||CATHETER, CORONARY, ATHERECTOMY|DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2016|06/07/2016|||OK30|Use an alternate supplier for a component used to construct the OAS Pump.
P130019|S008|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/13/2016|06/03/2016|||OK30|Changes to the software and hardware associated with the Rechargeable Neuroregulator (RNR) final assembly and circuit assembly test fixtures,
P030011|S044|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/13/2016|07/05/2016|||APPR|Approval for a minor change to the Freedom Driver Printed Circuit Board Assembly (PCBA) and addition of an alternate qualified supplier.
P930014|S091|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF IQ TORIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|05/13/2016|08/05/2016|||APPR|Approval for AcrySof® IQ Toric IOL with the UltraSert Pre-Loaded Delivery System, Models AU00T3, AU00T4, AU00T5, AU00T6, AU00T7, AU00T8 and AU00T9.
P030009|S087|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|Integrity Coronary Stent Systems|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2016|06/15/2016|||OK30|Add a manufacturing facility for the catheter subassembly.
P110013|S070|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2016|06/15/2016|||OK30|Add a manufacturing facility for the catheter subassembly.
P870072|S062|THORATEC LABORATORIES CORP.|2023 EIGHTH ST.||BERKELEY|CA|94710||Ventricular (assisst) bypass|THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2016|06/14/2016|||OK30|Implementation of a new facility (same supplier) to provide the Battery Pack Assembly TLC II for the Thoratec Ventricular Assist Device (VAD).
P080011|S044|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2016|06/10/2016|||OK30|Validation of Line 4 at the CooperVision Inc. Hamble, UK manufacturing facility to manufacture Biofinity Energys asphere minus power (plano to -12.00D, inclusive) and plus power (+0.25D to +8.00D, inclusive) lenses within the power ranges.
P080011|S045|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2016|06/09/2016|||OK30|Removal of the osmolarity surveillance testing performed on the final packaged product.
P130009|S058|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2016|05/23/2016|||APPR|Approval for a new in-process inspection for device accessories.
P140031|S016|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/16/2016|05/23/2016|||APPR|Approval for a new in-process inspection for device accessories.
P010031|S552|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Concerto II CRT-D D274TRK, Consulta CRT-D D204TRM, Consulta CRT-D D224TRK, Maximo II CRT-D D264TRM, D284TRK, Protecta CR|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2016|06/14/2016|||OK30|Update to the high voltage capacitor inspection requirements.
P980016|S591|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Maximo II ICD D264DRM, D264VRM, D284VRC, D284DRG; Protecta ICD D334DRG, D334VRG, D334DRM, D334VRM; Protecta XT ICD D314D|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2016|06/14/2016|||OK30|Update to the high voltage capacitor inspection requirements.
P020056|S033|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2016|06/13/2016|||OK30|New style of pump to replace the pumps currently used to dispense silicone gel components from their storage drums into the mixing vessel.
P040046|S015|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2016|06/13/2016|||OK30|New style of pump to replace the pumps currently used to dispense silicone gel components from their storage drums into the mixing vessel.
P040037|S092|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2016|06/07/2016|||OK30|Updates to supplier manufacturing equipment.
P880090|S029|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|PMMA ABSORBING ANTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2016|06/15/2016|||OK30|Add an alternate packaging component supplier for the PMMA Absorbing Anterior Chamber Intraocular Lenses, Models S122UV and L122UV and PMMA Absorbing Posterior Chamber Intraocular Lenses, Model EZE-60.
P130006|S031|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2016|06/07/2016|||OK30|Updates to supplier manufacturing equipment.
P840039|S061|Bausch & Lomb, Inc.|50 Technology||Irvine|CA|92618||intraocular lens|PMMA ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/17/2016|06/15/2016|||OK30|Add an alternate packaging component supplier for the PMMA Absorbing Anterior Chamber Intraocular Lenses, Models S122UV and L122UV and PMMA Absorbing Posterior Chamber Intraocular Lenses, Model EZE-60.
P100044|S021|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL AND PROPEL MINI SINUS IMPLANTS|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2016|06/17/2016|||OK30|Modification of two packaging related processes: 1) the addition of an automated Desiccant Dispenser to automatically dispense the desiccants used in the manufacturing product packaging; and 2) the addition of a semi-automated Component Verification System for verifying the presence of components during packaging. These changes are being made to implement the addition of two new equipment systems to facilitate the conversion from manual to automated processes
P980040|S069|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1-PIECE IOL, TECNIS 1-PIECE OPTIBLUE IOL, PRELOADED TECNIS 1-PIECE IOL, PRELOADED TECNIS 1-PIECE OPTIBLUE IOL, PR|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2016|06/17/2016|||OK30|Expansion of the compressed air system.
P990080|S041|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC MONOFOCAL IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2016|06/17/2016|||OK30|Expansion of the compressed air system.
P150012|S005|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGEVITY LEADS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/18/2016|06/15/2016|||OK30|Secondary supplier for the helix component.
P020014|S046|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|ESSURE SYSTEM|HHS|OB|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|05/19/2016|11/15/2016|||APPR|Approval for changes to the physicians instructions for use and patient information booklet including a boxed warning and a patient decision checklist.
P880047|S022|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2016|10/24/2016|||APPR|Approval for consolidation of the knitting processes into a single building for the sub-tier supplier, Secant Medical for the GYNECARE INTERCEED® Absorbable Adhesion Barrier.
P950009|S021|BD DIAGNOSTICS|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED|BD FOCALPOINT GS IMAGING SYSTEM|MNM|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2016|06/17/2016|||OK30|Changes to the printed circuit board reported in this supplement in conjunction with the changes to replace VIC chip and change of manufacturing supplier qualify.
P070026|S036|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2016|06/17/2016|||OK30|Change of a second-tier supplier of a raw material used in products of the CERAMAX® Ceramic Total Hip System.
P130013|S009|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE|NGV|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2016|08/04/2016|||APPR|Approval for a manufacturing site located at Boston Scientific Corporation, Maple Grove Facility located at One Scimed Place, Maple Grove, Minnesota, 55311 as an additional manufacturing site for the Watchman Closure Device with Delivery System.
P100021|S052|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/19/2016|06/16/2016|||OK30|Addition of an inspection step to the rear handle assembly process; 2) narrowing of the thread radius dimension tolerances on the handle lock; and 3) addition of detailed cleaning instructions at supplier for the moulding equipment.
P010030|S076|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2016|06/17/2016|||OK30|Multiple changes including the addition of an automated test fixture, automation of specific test steps, expansion of test coverage to include the recently approved WCD model 4000B and correction of test limits used in service/rework process.
N12159|S037|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FAMILY OF ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2016|06/17/2016|||OK30|Existing supplier of critical components would like to qualify a site change to consolidate existing manufacturing processes and equipment.
P110010|S126|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND PROMUS PREMIER EVEROLIMUS-ELUTING PLA|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2016|06/16/2016|||OK30|Introduce an alternate port mandrel manufacturing aid into the stent delivery catheter manufacturing process.
P150003|S014|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2016|06/16/2016|||OK30|Introduce an alternate port mandrel manufacturing aid into the stent delivery catheter manufacturing process.
P010012|S420|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|INGEVITY LEAD|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2016|07/13/2016|||APPR|Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.
P150012|S006|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ACUITY X4 LEAD|LWP|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/20/2016|07/13/2016|||APPR|Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.
P110013|S071|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2016|06/22/2016|||OK30|Implement an alternate control check for the Parylene coating process.
P150033|S003|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|MEDTRONIC MICRA TRANSCATHETER PACING SYSTEM|PNJ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|05/23/2016|07/18/2016|||APPR|Approval for shelf life extension to 12 months.
P970003|S200|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR.|LYJ|NE|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/23/2016|11/23/2016|||APPR|The Office of Compliance recommends that this supplement as "Approve PMA - No Inspection Necessary".  A post-approval of the facility in Costa Rica should be conducted.
P130028|S008|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2016|06/22/2016|||OK30|Use of an alternate polycarbonate/acrylonitrile butadiene styrene (PC/ABS) resin material to manufacture the lower housing of the Trial Cable Interface assembly.
P860057|S149|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/24/2016|06/23/2016|||OK30|Additional laser cutting system to cut fabric components during manufacturing.
P040046|S016|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|05/24/2016|08/17/2016|||APPR|Approval for changes to the presentation format of the indication-specific brochures and mini-brochure.
P970029|S029|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|TMR HOLMIUM LASER SYSTEM|MNO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/21/2016|||OK30|Change to the frequency of the bioburden assessments, from quarterly to annually, for the SoloGrip III and PEARL 5.0 Handpieces.
P970029|S030|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|TMR HOLMIUM LASER SYSTEM|MNO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/23/2016|||OK30|Adding an incoming visual inspection to be conducted after sterilization and before shipping of the laser handpieces.
P130009|S059|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/10/2016|||OK30|Changes to manufacturing aides and manufacturing specifications for the loader accessory.
P140031|S017|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARD SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/10/2016|||OK30|Changes to manufacturing aides and manufacturing specifications for the loader accessory.
P100047|S075|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/23/2016|||APPR|Approval for the manufacturing process updates for the HeartWare Left Ventricular Assist Device Controller.
P910001|S086|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|EXCIMER LASER CORONARY ATHERECTOMY CATHETER|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/16/2016|||OK30|Addition of a manufacturing tool used in the fiber trimming process.
P960042|S054|SPECTRANETICS CORP.|96 TALAMINE CT.||COLORADO SPRINGS|CO|80907|5159|DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS|SPECTRANETICS LASER SHEATHS|MFA|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/16/2016|||OK30|Addition of a manufacturing tool used in the fiber trimming process.
P100047|S076|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/24/2016|||OK30|Implementation of changes to the Splice Kit Assembly and the HVAD Large OD Sheath.
P810006|S072|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/22/2016|||OK30|Create a new procedure, Cutting and Inspection Procedure - ACS, for the cutting and inspection of Absorbable Collagen Sponge (ACS)-(EU) used as a component of the InductOs marketed in the European Union (EU) product in room 304, 105 Morgan Lane, Plainsboro, New Jersey. This procedure directs operators to cull out and reject any cut collagen sponge that has visible foreign matter embedded in or on the surface of the collagen sponge during the inspection process. In addition, a procedure, Packaging of ACS Sponge 3”x 4” or 1”x 2” 6-Pack or 1”x 2” 2-Packs on the Belco Sealer # 2, has been revised to direct operators to reject packaged product that has visible foreign matter on the product or inside the primary or secondary packaging.
P140010|S018|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|10/31/2016|||APPR|Approval for modifications to the potency and related substances test method to include relative retention time and correction factors.
P850010|S071|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/25/2016|06/22/2016|||OK30|Create a new procedure, Cutting and Inspection Procedure - ACS, for the cutting and inspection of Absorbable Collagen Sponge (ACS)-(EU) used as a component of the InductOs marketed in the European Union (EU) product in room 304, 105 Morgan Lane, Plainsboro, New Jersey. This procedure directs operators to cull out and reject any cut collagen sponge that has visible foreign matter embedded in or on the surface of the collagen sponge during the inspection process. In addition, a procedure, Packaging of ACS Sponge 3”x 4” or 1”x 2” 6-Pack or 1”x 2” 2-Packs on the Belco Sealer # 2, has been revised to direct operators to reject packaged product that has visible foreign matter on the product or inside the primary or secondary packaging.
P050037|S071|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/23/2016|||OK30|Change in the calcium hydroxylapatite particle component manufacturing throughput.
P050052|S083|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE INJECTABLE IMPLANT|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/23/2016|||OK30|Change in the calcium hydroxylapatite particle component manufacturing throughput.
P140010|S019|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/24/2016|||OK30|Alternate incoming analytical test procedure for the API.
P100021|S053|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|ENDURANT, ENDURANT II, ENDURANT II AORTO-UNI-ILIAC (AUI), ENDURANT IIS STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/24/2016|||OK30|Relocation of certain stent graft material manufacturing process steps at an approved supplier.
P100009|S019|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP NT CLIP DELIVERY SYSTEM|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/24/2016|||OK30|Add the option to sterilize the MitraClip NT Clip Delivery System (CDS) and Steerable Guide Catheter (SGC) at the existing alternate sterilization site.
N970003|S190|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Ingenio™ 2 Pacemakers; ALTRUA 2™ Models: S701, S702, S722; ESSENTIO™ Models: L100, L101, L121; PROPONENT™ Models: L200,|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/20/2016|||OK30|Remove the final finish wetblast manufacturing process step.
P960040|S373|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ORIGEN ™ EL ICD: D050, D051, D052, D053; INOGEN ™ EL ICD: D140, D141, D142, D143; DYNAGEN ™ EL ICD: D150, D151, D152, D1|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/20/2016|||OK30|Remove the final finish wetblast manufacturing process step.
P010012|S421|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|DYNAGEN ™ CRT-D: G150, G151, G154 DYNAGEN ™ X4 CRT-D: G156, G158; INOGEN ™ CRT-D: G140, G141 INOGEN ™ X4 CRT-D: G146, G1|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/20/2016|||OK30|Remove the final finish wetblast manufacturing process step.
P030005|S137|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|Ingenio™ 2 CRT-P Devices; VALITUDE™ Model: U125; VALITUDE™ X4 Model: U128|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/20/2016|||OK30|Remove the final finish wetblast manufacturing process step.
P150012|S007|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO VALITUDE™ MRI: L110, L111, L131;PROPONENT VALITUDE™ MRI: L210, L211, L231; ACCOLADE VALITUDE™ MRI: L310, L311,|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/26/2016|06/20/2016|||OK30|Remove the final finish wetblast manufacturing process step.
P980035|S464|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Advisa MRI DR & SR Surescan Implantable Pulse Generators Models A2DR01 & A3SR01|NVZ|CV|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|03/11/2016|09/07/2016|||APPR|Approval for 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
P130028|S009|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|05/27/2016|07/14/2016|||APPR|Approval for software and instructions for use (IFU) changes to the Model 4500 Clinician Programmer.
P920015|S180|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|Sprint Quattro Lead|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/17/2016|||OK30|Change to the adhesive mixture process used during lead backfill.
P970051|S146|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Addition of a welding rework process to the existing welding process joining the top shell to the brazed chassis.
P010012|S422|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Contak CD, Contak Renewal, Livian ICD Families; EasyTrak, Acuity Spiral Lead Families; Cognis, Energen, Incepta, Origen,|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P960006|S046|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P960004|S076|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|THINLINE/FINELINE Family of ENDOCARDIAL PACING LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P150012|S008|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P830060|S081|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK ICD Family|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P910073|S135|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK LEAD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P910077|S153|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK PRX and VENTAK MINI ICD Families|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P930035|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|VENTAK(R) P2 ICD FAMILY|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P940008|S032|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|RES-Q and RES-Q MICRON ICD and ICD Lead Family|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P950001|S028|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|SELUTE Pacing Lead Family|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/23/2016|||OK30|Alternate sterilization recipe and addition of a new sterilization release mechanism.
P110016|S032|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL), (UNI-DIRECTIONAL)|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/14/2016|||OK30|Acceptance of a custom test fixture for confirmation of correct thermocouple in-process assembly for the FlexAbility manufacturing line.
P040014|S030|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|THERAPY ABLATION CATHETER (INCLUDING BI-DIRECTIONAL) THERAPY 4MM THERMISTOR ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/24/2016|||OK30|Acceptance to replace test equipment (RF generators) used for final inspection testing for the Therapy Ablation Series Catheters.
P040042|S035|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY DUAL 8 THERAPY 8MM THERMISTER ABLATION CATHETER, SAFIRE TX BI-DIRECTIONAL ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/24/2016|||OK30|Acceptance to replace test equipment (RF generators) used for final inspection testing for the Therapy Ablation Series Catheters.
P060019|S037|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETER, SAFIRE BLU ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/24/2016|||OK30|Acceptance to replace test equipment (RF generators) used for final inspection testing for the Therapy Ablation Series Catheters.
P110016|S033|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|COOL PATH DUO ABLATION CATHETER MEDIGUIDE ENABLED, AND SAFIRE DUO ABLATION CATHETER MEDIGUIDE ENABLED, THERAPY COOL PATH|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/24/2016|||OK30|Acceptance to replace test equipment (RF generators) used for final inspection testing for the Therapy Ablation Series Catheters.
P970018|S033|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD SUREPATH COLLECTION VIAL|MKQ|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|05/27/2016|12/02/2016|||APPR|approval for a change to the labeling on the BD SurePath™ Collection Vial for use with the BD PrepStain system.
P950029|S110|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemakers|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/22/2016|||OK30|Use of Automated Optical Inspection in a portion of the final electrical assembly visual inspection.
P030053|S034|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/27/2016|06/22/2016|||OK30|Implementation of a multi-booth spray system for shell manufacture.
P950037|S163|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|Various models of Evia, Entovis, Estella, Effecta, Ecuro, Eluna, Etrinsa, Epyra Pulse Generator Families|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/24/2016|||OK30|Alternate supplier of the epoxy resin used in the device headers.
P050023|S099|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|Various models of single chamber ICDS in the Lumax, Ilesto, Iforia, Iperia, Itrevia, Inventra Families, Various models o|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/24/2016|||OK30|Alternate supplier of the epoxy resin used in the device headers.
P070008|S073|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|Stratos LV/LV-T, Evia/Entovis HF/HF-T, Eluna/Erinsa/Epyra 8 HF-T CRT-Ps|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/24/2016|||OK30|Alternate supplier of the epoxy resin used in the device headers.
P970018|S034|BD Diagnostic Systems|4025 STIRRUP CREEK DRIVE|SUITE 400|DURHAM|NC|27703||Processor, cervical cytology slide, automated|BD TOTALYS SLIDEPREP|MKQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/17/2016|||OK30|Manufacturing site change.
P050037|S072|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE Injectable Implant|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|10/26/2016|||APPR|Approval for manufacturing process changes to the final product syringe filling process.
P050052|S084|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE Injectable Implant; RADIESSE (+) Lidocaine Dermal Filler|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|10/26/2016|||APPR|Manufacturing process changes to the final product syringe filling process.
P050037|S073|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE Injectable Implant|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/27/2016|||OK30|Modification of particle manufacturing process steps to eliminate a redundant test.
P050052|S085|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE (+) Lidocaine Dermal Filler|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/27/2016|||OK30|Modification of particle manufacturing process steps to eliminate a redundant test.
P040047|S043|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE|COAPTITE Injectable Implant|LNM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/27/2016|||OK30|Modification of particle manufacturing process steps to eliminate a redundant test.
P860004|S250|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ASCENDA INTRATHECAL CATHETER WITH 86 CM SPINAL SEGMENT, 66CM SPINAL SEGMENT, 86 CM SPINAL SEGMENT REVISION KIT, ACCESSOR|LKK|HO|Real-Time Process|Change Design/Components/Specifications/Material|N|05/31/2016|09/09/2016|||APPR|Approval for the addition of a low-PFOA (perfluorooctanoic acid) polytetrafluoroethylene (PTFE) coating to the Anchor Dispenser Tool (ADT) to address customer complaints of difficulty deploying the Ascenda anchor from the Anchor Dispenser Tool; the addition of the flare to the hypotube; the updated materials list in the Ascenda Implant Manual and minor changes to dimension tolerances on the Anchor Dispenser Tool.
P840001|S328|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEMS.|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/29/2016|||OK30|Implement a rework process for filling bubbles within the medical adhesive on the Implantable Pulse Generator (IPG) connector blocks.
P960009|S251|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/29/2016|||OK30|Implement a rework process for filling bubbles within the medical adhesive on the Implantable Pulse Generator (IPG) connector blocks.
P910061|S023|BAUSCH & LOMB|50 Technology Drive||Irvine|CA|92618||intraocular lens|SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|05/31/2016|06/27/2016|||OK30|Addition of an alternate packaging component supplier for the Sofport Posterior Chamber Intraocular Lenses.
P130017|S010|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|05/31/2016|08/19/2016|||APPR|Approval for design changes to Cologuard Collection Kit and associated patient labeling.
P110012|S010|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT|OWE|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|07/13/2016|||OK30|Removal of testing at the cell pellet stage for 2 components of the PathVysion HER-2 DNA Probe Kit: (1) ProbeChek HER-2/neu Cut-Off Control Slides (List No. 02J04-030), (2) ProbeChek HER-2/neu Normal Control Slides (List No. 02J05-030). The second change involves adding the RM2255 Rotary Microtome to the manufacturing procedures of the ProbeChek HER-2/neu Cut-Off Control Slides, the ProbeChek Her-2/neu Normal Control Slides, and 2 components of the Vysis ALK Break Apart FISH Probe Kit: (1) ProbeChek ALK Negative Control Slides (06N38-005), (2) ProbeChek ALK Postitive Control Slides (06N38-010).
P960016|S066|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|LIVEWIRE TC ABLATION CATHETER  AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/29/2016|||OK30|Change to the current Livewire TC and Safire Bi-Directional in-process tensile test frequency for catheter ring brazing and catheter tip brazing.
P980024|S014|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATH VYSION HER-2 DNA PROBE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|07/13/2016|||OK30|Removal of testing at the cell pellet stage for 2 components of the PathVysion HER-2 DNA Probe Kit: (1) ProbeChek HER-2/neu Cut-Off Control Slides (List No. 02J04-030), (2) ProbeChek HER-2/neu Normal Control Slides (List No. 02J05-030). The second change involves adding the RM2255 Rotary Microtome to the manufacturing procedures of the ProbeChek HER-2/neu Cut-Off Control Slides, the ProbeChek Her-2/neu Normal Control Slides, and 2 components of the Vysis ALK Break Apart FISH Probe Kit: (1) ProbeChek ALK Negative Control Slides (06N38-005), (2) ProbeChek ALK Postitive Control Slides (06N38-010).
P980040|S070|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC INTRAOCULAR LENSES, TECNIS ACRYLIC INTRAOCULAR LENS, TECNIS ITEC PRELOADED DELIVERY SYSTEM.|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/27/2016|||OK30|Alternate sheet casting process.
P100017|S018|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|ABBOTT REALTIME HCV ASSAY|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/30/2016|||OK30|Change to bring reagent filling from an external supplier to an in-house process.
P960028|S039|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|REZOOM MULTIFOCAL INTRAOCULAR LENS|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/27/2016|||OK30|Alternate sheet casting process.
P080010|S013|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||LENS, MULTIFOCAL INTRAOCULAR|TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)|MFK|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/27/2016|||OK30|Alternate sheet casting process.
P120012|S014|ABBOTT MOLECULAR|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Assay, genotyping, hepatitis c virus|ABBOTT REALTIME HCV GENOTYPE II ASSAY|OBF|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/30/2016|||OK30|Change to bring reagent filling from an external supplier to an in-house process.
P990080|S042|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 3-PCS MONOFOCAL LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/27/2016|||OK30|Alternate sheet casting process.
P980016|S592|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM II DR/GEM II VR/GEM III DR/GEM III VR/ENTRUST/INTRINSIC 30/INTRINSIC/MARQUIS DR/MARQUIS VR/MAXIMO II DR/MAXIMO II/MA|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2016|08/07/2016|||APPR|Approval for a web-based battery longevity estimation tool for ICD and CRT-D devices and updates to the existing battery longevity estimation tools.
P010031|S553|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO/CONCERTO II/CONSULTA DF4/CONSULTA/INSYNC II PROTECT/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/INSYNC II MA|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2016|08/07/2016|||APPR|Approval for a web-based battery longevity estimation tool for ICD and CRT-D devices and updates to the existing battery longevity estimation tools.
P980050|S104|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|GEM III AT ICD|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/01/2016|08/07/2016|||APPR|Approval for a web-based battery longevity estimation tool for ICD and CRT-D devices and updates to the existing battery longevity estimation tools.
P010019|S051|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT AND DAY (LOTRAFILCON A AND B) EXTENDED WEAR SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/23/2016|||OK30|Qualification of two FTNIR instruments that are used for Betacon Macromer raw material incoming inspection quality control testing.
P000030|S003|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|FOCUS NIGHT & DAY (LOTRAFILCON A) EXTENDED WEAR SOFT CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/01/2016|06/23/2016|||OK30|Qualification of two FTNIR instruments that are used for Betacon Macromer raw material incoming inspection quality control testing.
P100013|S013|Cordis Corporation|6500 Paseo Padre Parkway||Fremont|CA|94555||Device, hemostasis, vascular|CORDIS EXOSEAL VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|06/30/2016|||OK30|Transfer the indicator wire component's manufacturing process to an alternate manufacturing site.
P880081|S040|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS CL FOLDABLE SILICONE INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|07/29/2016|||OK30|Change in the Bioburden Test Method used in the manufacturing of the TECNIS CL, Model Z9002, SENSAR Acrylic Intraocular Lenses (IOLs), Models AR40, AAB00, ZCB00, ZCB00V, and ZMB00, and TECNIS Acrylic Monofocal IOL, Model ZA9003.
P990080|S043|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS ACRYLIC INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|07/29/2016|||OK30|Change in the Bioburden Test Method used in the manufacturing of the TECNIS CL, Model Z9002, SENSAR Acrylic Intraocular Lenses (IOLs), Models AR40, AAB00, ZCB00, ZCB00V, and ZMB00, and TECNIS Acrylic Monofocal IOL, Model ZA9003.
P980040|S071|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|07/29/2016|||OK30|Change in the Bioburden Test Method used in the manufacturing of the TECNIS CL, Model Z9002, SENSAR Acrylic Intraocular Lenses (IOLs), Models AR40, AAB00, ZCB00, ZCB00V, and ZMB00, and TECNIS Acrylic Monofocal IOL, Model ZA9003.
P030017|S252|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|06/29/2016|||OK30|Reduce the minimum time required for the Precision Novi IPG subassembly vacuum bake process.
P990009|S042|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Absorbable collagen hemostatic agent with thrombin|FLOSEAL HEMOSTATIC MATRIX|PMX|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|11/22/2016|||APPR|Approval for artwork changes to the exterior of the product syringes, removal of a colorant clarifier from the syringe plunger, and addition of a black colorant to the plunger tip of the mixing syringe in order to support the addition of an alternative syringe supplier.
P050023|S100|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PROMRI ICD/CRT-D SYSTEM|MRM|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/02/2016|08/01/2016|||APPR|Approval of the post-approval study protocol.
P080006|S094|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|06/24/2016|||OK30|Alternate supplier of the conductor coils.
P100022|S018|COOK MEDICAL INCORPORATED|750 DANIELS WAY|P.O. BOX 489|BLOOMINGTON|IN|47402|0489|Stent, superficial femoral artery, drug-eluting|ZILVER PTX DRUG-ELUTING PERIPHERAL STENT|NIU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|07/01/2016|||OK30|Alternate resin for several delivery system components.
P130009|S060|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|06/27/2016|||APPR|Approval for the addition of a new inspection step to the final inspection process for the Edwards Expandable Introducer Sheath Set.
P050017|S013|Cook Incorporated|P.O.BOX 489||BLOOMINGTON|IN|47402||STENT, ILIAC|ZILVER VASCULAR STENT|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/02/2016|07/01/2016|||OK30|Alternate resin for several delivery system components.
P120016|S020|CARDIVA MEDICAL, INC.|888 W. MAUDE AVE||SUNNYVALE|CA|94085||Device, hemostasis, vascular|VASCADE VASCULAR CLOSURE SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2016|08/01/2016|||APPR|Approval for a change to the material of the Joiner component of the VASCADE 6/7F Sleeve with Grip subassembly.
P010012|S423|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ACUITY X4 STRAIGHT, ACUITY X4 SPIRAL S, ACUITY X4 SPIRAL L Quadripolar Coronary Venous Pace/Sense Leads|NIK|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/03/2016|08/23/2016|||APPR|Approval for modifications to the terminal connector.
P060022|S023|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|AKREOS INTRAOCULAR LENS,MODEL AO60 and MI60L|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2016|06/23/2016|||OK30|Addition of an alternative Fourier Transform Infrared Spectroscopy (FTIR) laboratory.
P910056|S023|Bausch & Lomb, Inc.|50 Technology Drive||Irvine|CA|92618||intraocular lens|ENVISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS, MODEL MX60|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/03/2016|06/23/2016|||OK30|Addition of an alternative Fourier Transform Infrared Spectroscopy (FTIR) laboratory.
P080006|S095|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD|OJX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/03/2016|07/13/2016|||APPR|Approval for a change to the connector sleeve component.
P040044|S073|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNX ACE VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|07/06/2016|||OK30|Add a second sterilization line at a previously approved alternate sterilization facility (Synergy Health in San Diego, California).
P840001|S329|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|07/01/2016|||OK30|Relocate the manufacturing facility for an external supplier of components for neuromodulation leads.
N970012|S116|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|06/30/2016|||OK30|Changes to the components and cleaning method of the equipment for the InhibiZone production line.
P960009|S252|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|07/01/2016|||OK30|Relocate the manufacturing facility for an external supplier of components for neuromodulation leads.
P000053|S064|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 ARTIFICIAL URINARY SPHINCTER WITH INHIBIZONE TREATMENT|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|06/30/2016|||OK30|Changes to the components and cleaning method of the equipment for the InhibiZone production line.
P970004|S214|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (URINARY)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|07/01/2016|||OK30|Relocate the manufacturing facility for an external supplier of components for neuromodulation leads.
P080025|S109|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (BOWEL)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|07/01/2016|||OK30|Relocate the manufacturing facility for an external supplier of components for neuromodulation leads.
P980018|S022|DAKO A/S|42 PRODUKTIONSVEJ||GLOSTRUP||DK-26|2600|SYSTEM, TEST, HER-2/NEU, IHC|HERCEPTEST|MVC|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|06/06/2016|07/22/2016|||APPR|Approval for the DakoLink software version 4.1 update for the HercepTest.
P110013|S072|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY  ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|07/06/2016|||OK30|Option to use an Incubator Shaker apparatus for elution testing.
P140031|S018|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|Commander Delivery System (Including Loader)|NPT|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|11/17/2016|||APPR|Approval for the addition of the Draper, Utah manufacturing facility to manufacture the Commander Delivery System.
P110023|S019|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|06/22/2016|||OK30|Changes to in-process product acceptance activities.
P100009|S020|ABBOTT VASCULAR INC.|4045 CAMPBELL AVENUE||MENLO PARK|CA|94025||Mitral valve repair devices|MITRACLIP AND MITRACLIP NT CLIP DELIVERY SYSTEM|NKM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/06/2016|07/05/2016|||OK30|Expand the cleanroom at the Menlo Park, California facility.
P150004|S002|Spinal Modulation, Inc|1135 O'BRIEN DR||MENLO PARK|CA|94025||Dorsal root ganglion stimulator for pain relief|PROCLAIM DORSAL ROOT GANGLION (DRG) NEUROSTIMULATION SYSTEM|PMP|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/2016|11/28/2016|||APPR|Approval of the Clinician Programmer App (Version 3.3) Model 3874 and Programmer App (Version 3.3) Model 3875, and the Proclaim DRG Neurostimulation System which includes the following components:3664	Proclaim DRG IPG7108	Port PlugMN15000	Tunneling Tool KitNot applicable	Torque WrenchNot applicable	Pocket SizerMN10450-50	Implant Lead Kit, 50cmMN10450-50A	Implant Lead Kit, SlimTip, 50cmNot applicable	Soft Tissue AnchorMN12050	Lead Accessory Kit3874	St. Jude Medical Clinician Programmer App3875	St. Jude Medical Patient Controller App
P010032|S118|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION (SCS) EXTERNAL PROGRAMMER APPS|LGW|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/2016|11/28/2016|||APPR|Approval for the Clinician Programmer App (Version 3.3) Model 3874 and Programmer App (Version 3.3) Model 3875, and the Proclaim DRG Neurostimulation System which includes the following components:3664	Proclaim DRG IPG7108	Port PlugMN15000	Tunneling Tool KitNot applicable	Torque WrenchNot applicable	Pocket SizerMN10450-50	Implant Lead Kit, 50cmMN10450-50A	Implant Lead Kit, SlimTip, 50cmNot applicable	Soft Tissue AnchorMN12050	Lead Accessory Kit3874	St. Jude Medical Clinician Programmer App3875	St. Jude Medical Patient Controller App
P140009|S015|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION (DBS) EXTERNAL PROGRAMMER APPS|MHY|NE|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/06/2016|11/28/2016|||APPR|Approval of the Clinician Programmer App (Version 3.3) Model 3874 and Programmer App (Version 3.3) Model 3875, and the Proclaim DRG Neurostimulation System which includes the following components:3664	Proclaim DRG IPG7108	Port PlugMN15000	Tunneling Tool KitNot applicable	Torque WrenchNot applicable	Pocket SizerMN10450-50	Implant Lead Kit, 50cmMN10450-50A	Implant Lead Kit, SlimTip, 50cmNot applicable	Soft Tissue AnchorMN12050	Lead Accessory Kit3874	St. Jude Medical Clinician Programmer App3875	St. Jude Medical Patient Controller App
P010030|S077|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Addition of automated incoming inspection measuring test equipment.
P140003|S008|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA VENTRICULAR SUPPORT SYSTEM|OZD|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/07/2016|12/01/2016|||APPR|Approval to expand the indication for use to include high risk percutaneous coronary interventions for the Impella CP.
P030053|S035|MENTOR CORP.|33 TECHNOLOGY DRIVE||IRVINE|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYGEL BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/05/2016|||OK30|Use of previously approved Semi-Automated Primary Packaging Equipment SPPS following relocation from the Main Assembly Controlled Manufacturing Environment CME room to the Primary Packaging CME Room at the Mentor Irving, Texas facility.
P060028|S018|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, noninflatable, internal, silicone gel-filled|MENTOR MEMORYSHAPE BREAST IMPLANTS|FTR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/05/2016|||OK30|Use of previously approved Semi-Automated Primary Packaging Equipment SPPS following relocation from the Main Assembly Controlled Manufacturing Environment CME room to the Primary Packaging CME Room at the Mentor Irving, Texas facility.
P990075|S037|MENTOR WORLDWIDE LLC|33 Technology Drive||Irvine|CA|92618||Prosthesis, breast, inflatable, internal, saline|MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/05/2016|||OK30|Use of previously approved Semi-Automated Primary Packaging Equipment SPPS following relocation from the Main Assembly Controlled Manufacturing Environment CME room to the Primary Packaging CME Room at the Mentor Irving, Texas facility.
P840001|S330|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Process parameter changes related to package sealing, tray cleaning, and packaging inspection.
P860004|S251|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Process parameter changes related to package sealing, tray cleaning, and packaging inspection.
P960009|S253|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Process parameter changes related to package sealing, tray cleaning, and packaging inspection.
P970004|S215|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Process parameter changes related to package sealing, tray cleaning, and packaging inspection.
P080025|S110|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Process parameter changes related to package sealing, tray cleaning, and packaging inspection.
P020045|S075|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CATHETERS, FREEZOR MAX SURGICAL CATHETER|LPB|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/29/2016|||APPR|Approval for modification to the display monitor of the Gen V Universal CryoConsole (model 106A3).
P100010|S056|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ST CARDIAC|OAE|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/29/2016|||APPR|Approval for modification to the display monitor of the Gen V Universal CryoConsole (model 106A3).
P100010|S057|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT FAMILY CARDIAC CRYOABLATION CATHETERS|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Acceptance of new impedance criteria for the fluid detection circuit and modified related in-process and final inspection test equipment software.
P020004|S132|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS & ILIAC BRANCH ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Implementation of a change to the thermal processing of Ultra Thin Wall (UTW) basetube graft components of the Gore Excluder AAA Endoprosthesis and the Gore Excluder Iliac Branch Endoprosthesis.
P020045|S076|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR FAMILY CARDIAC CRYOABLATION CATHETERS|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/07/2016|07/07/2016|||OK30|Acceptance of new impedance criteria for the fluid detection circuit and modified related in-process and final inspection test equipment software.
P140020|S007|MYRIAD GENETIC LABORATORIES|320 Wakara Way||Salt Lake City|UT|84108||Cancer-related germline gene mutation detection system|BRACANALYSIS CDx|PJG|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|06/07/2016|06/17/2016|||APPR|Approval to remove the DNA extraction system from serialization, and to remove non-critical instruments from the specified device components.
P130019|S009|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|06/07/2016|06/27/2016|||APPR|Approval of an amended protocol for the ODE Lead PMA Post-Approval Study.
N12159|S038|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL  ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2016|07/01/2016|||OK30|Implementation of new production equipment (automatic foiling equipment).
P050018|S022|SPECTRANETICS CORP.|5055 BRANDIN COURT||FREMONT|CA|94538||Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|ANGIOSCULPT(R) PTCA SCORING BALLOON CATHETER|NWX|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/08/2016|09/06/2016|||APPR|Approval for a non-patient contacting material change for a component of the AngioSculpt PTCA Scoring Balloon Catheter.
P910001|S087|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/08/2016|07/07/2016|||APPR|Approval for the Laser Certification Label modification to conform with CDRH recommendations per Laser Notice 50.
P140026|S003|SILK ROAD MEDICAL, INC|735 NORTH PASTORIA AVE||SUNNYVALE|CA|94085||STENT, CAROTID|ENROUTE TRANSCAROTID STENT SYSTEM|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/08/2016|07/05/2016|||OK30|Supplier site change.
P140015|S009|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Pump, infusion, insulin, to be used with invasive glucose sensor|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/08/2016|||OK30|Implement a pump refurbishment process for the t:slim G4 Insulin Pump.  The refurbishment activities will be conducted in the same building where current pump manufacturing occurs, 11045 Roselle, San Diego, CA.  The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 System.
P000025|S088|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|COMBI 40+ COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/08/2016|||OK30|Gain additional manufacturing space and flexibility with respect to allocation of work spaces for implant production and process flow within implant manufacturing.
P860004|S252|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/07/2016|||OK30|Component and manufacturing process changes to the Catheter Access Port (CAP) Valve, a subcomponent of the Model 8637 SynchroMed II Drug Infusion Pump  (Model 8637 Pump).
P980035|S465|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/05/2016|||OK30|Implementation of new laser welding equipment.
P840001|S331|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|MEDTRONIC SPINAL CORD STIMULATION THERAPY|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/06/2016|||OK30|Transfer of molding and assembly of the lead tip used in the Model 3888 Pisces-Quad® Lead, part number 103162001 from Medtronic Energy and Component Center (MECC), to Accumold located in Ankeny, Iowa.
P050023|S102|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Iperia 7 HF-T (DF-1) Iperia 7 HF-T (DF4) Inventra 7 HF-T (DF-1) Inventra 7 HF-T (DF4) Defibrillator, Automatic Implantab|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2016|07/27/2016|||APPR|Approval for the addition of the Siello S and Solia S leads to the ProMRI CRT-D system.
P950037|S165|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|Solia S 45, 53, 60 Siello S 45, 53, 60 Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Elec|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/09/2016|07/26/2016|||APPR|Approval for the addition of the Siello S and Solia S leads to the ProMRI CRT-D system.
P840001|S332|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/07/2016|||OK30|Addition of new peel test and pouch seal equipment used in the Pouch Sealing process and Blister Package and Pouch Peel Testing process and introduction of a new peel test operation procedure at the Medtronic Sullivan Lake facility.
P110033|S022|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLBELLA XC|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|10/03/2016|||APPR|Approval for changes to the dialysis and homogenization steps during the JUVEDERM VOLBELLA XC manufacturing process.
P860004|S253|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/07/2016|||OK30|Addition of new peel test and pouch seal equipment used in the Pouch Sealing process and Blister Package and Pouch Peel Testing process and introduction of a new peel test operation procedure at the Medtronic Sullivan Lake facility.
P960009|S254|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/07/2016|||OK30|Addition of new peel test and pouch seal equipment used in the Pouch Sealing process and Blister Package and Pouch Peel Testing process and introduction of a new peel test operation procedure at the Medtronic Sullivan Lake facility.
P970004|S216|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/07/2016|||OK30|Addition of new peel test and pouch seal equipment used in the Pouch Sealing process and Blister Package and Pouch Peel Testing process and introduction of a new peel test operation procedure at the Medtronic Sullivan Lake facility.
P960043|S093|ABBOTT VASCULAR INC.|400 Saginaw Drive||Redwood City|CA|94063||Device, hemostasis, vascular|Prostar XL 10F Percutaneous Vascular Surgical System|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/01/2016|||OK30|Modification to the pre-sterile Sheath-Guide tensile strength acceptance criteria.
P080025|S111|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM FOR BOWEL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/09/2016|07/07/2016|||OK30|Addition of new peel test and pouch seal equipment used in the Pouch Sealing process and Blister Package and Pouch Peel Testing process and introduction of a new peel test operation procedure at the Medtronic Sullivan Lake facility.
P030050|S024|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AND SCULPTRA AESTHETIC|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2016|07/07/2016|||OK30|Change to the sterility testing method.
P980041|S034|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|LOK|IM|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2016|11/18/2016|||APPR|Approval for a manufacturing process change to the Working Strength Particles Batch Size process, which is used in preparation of the paramagnetic particles (PMP) for use in the Access AFP Reagent.
P140003|S009|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA VENTRICULAR SUPPORT SYSTEMS|OZD|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/10/2016|08/09/2016|||APPR|Approval of the post-approval study protocol.
P860057|S150|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2016|07/05/2016|||OK30|Use of an automated method for wireforming.
P810031|S057|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2016|06/28/2016|||OK30|Change in shelf life due to the use of a new detergent in the manufacturing process.
P140003|S010|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|Impella Ventricular Support Systems|OZD|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/10/2016|08/09/2016|||APPR|Approval of the post-approval study protocol.
P860057|S151|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|Carpentier-Edwards PERIMOUNT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2016|07/01/2016|||OK30|Use of an automated laser measurement system for in-process dimensional inspections.
P030023|S005|OPHTEC USA, INC.|6421 CONGRESS AVE., SUITE 112||BOCA RATON|FL|33487||Ring, endocapsular|RINGJECT|MRJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/10/2016|07/06/2016|||OK30|Modification of the current blunt finish distal tip on capsular tension ring (CTR) injector to an angular (beveled) distal tip finish.
P050037|S074|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 1.5CC|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/26/2016|||APPR|Approval for modifications to the automated process for syringe filling.
P050052|S086|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 0.8cc|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/26/2016|||APPR|Approval for modifications to the automated process for syringe filling.
P060006|S074|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/13/2016|||OK30|Process changes associated with etching, polishing, and cleaning the stent component.
P060039|S070|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN STARFIX MODEL 4195 LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/07/2016|||OK30|Use of new instrumentation and an update to the analytical test method for monomer tubing.
P090003|S041|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/13/2016|||OK30|Process changes associated with etching, polishing, and cleaning the stent component.
P910023|S373|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|ELLIPSE FAMILY OF ICDS|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/13/2016|09/08/2016|||APPR|Approval for changes to the patient notifier assembly.
P010015|S301|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/06/2016|||OK30|New instrumentation and an updated test method for use in the battery manufacturing process.
P090013|S227|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/06/2016|||OK30|New instrumentation and an updated test method for use in the battery manufacturing process.
P980035|S466|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG, DR MRI IPG, SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/06/2016|||OK30|New instrumentation and an updated test method for use in the battery manufacturing process.
P070026|S037|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/01/2016|||OK30|Introduction of digital, automated hydrometers and water flow rate alarms for products of the CERAMAX® Ceramic Total Hip System that are processed through the final clean lines.
P830055|S171|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|07/01/2016|||OK30|Introduction of digital, automated hydrometers and water flow rate alarms for products of the LCS® Total Knee System that are processed through the final clean lines.
P010032|S119|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|SPINAL CORD STIMULATION SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|06/28/2016|||OK30|Change to the material used for the printed circuit board for the Genesic, Eon-C, Libra, and Libra XP Implantable Pulse Generators (IPGs), the Genesis and Eon/Protégé/Prodigy Patient Programmers, and the Libra and Brio Clinician Programmers.
P140009|S016|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|DEEP BRAIN STIMULATION SYSTEM (LIBRA, LIBRA XP)IPG'S; (LIBRA, BRIO) CLINICIAN PROGRAMMERS|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|06/28/2016|||OK30|Change to the material used for the printed circuit board for the Genesic, Eon-C, Libra, and Libra XP Implantable Pulse Generators (IPGs), the Genesis and Eon/Protégé/Prodigy Patient Programmers, and the Libra and Brio Clinician Programmers.
P940016|S021|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM|MMY|GU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/13/2016|09/09/2016|||APPR|Approval for changes in primary packaging of the H.E.L.P. Futura Set and individually packed filters.
P010003|S024|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2016|07/07/2016|||OK30|Change in the sampling plan used for BioGlue Surgical Adhesive testing.
P110033|S023|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Implant, dermal, for aesthetic use|JUVEDERM VOLBELLA XC|LMH|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/14/2016|09/01/2016|||APPR|Approval for the addition of a 0.55 mL-filled syringe configuration in the same 1 mL COC syringe for Juvederm VOLBELLA XC.
P050051|S031|ABBOTT LABORATORIES INC|100 ABBOTT PARK ROAD|DEPT 9VA- AP8-1|ABBOTT PARK|IL|60064||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ABBOTT ARCHITECT AUSAB|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/14/2016|07/13/2016|||OK30|Relocation of manufacturing activities for the purification and production of antigens used in final test components.
P970051|S147|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2016|10/28/2016|||APPR|Approval to outsource the piercing of the hermetization hole in the top shell to an approved supplier for the CI24RE(ST), CI24RE(CA), CI422 and Hybrid L24 implants.
P130016|S019|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS HYBRID L24 IMPLANT SYSTEM|PGQ|EN|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2016|10/28/2016|||APPR|Approval to outsource the piercing of the hermetization hole in the top shell to an approved supplier for the CI24RE(ST), CI24RE(CA), CI422 and Hybrid L24 implants.
P110035|S036|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2016|08/11/2016|||APPR|Approval for a manufacturing site located at Boston Scientific, 2 Scimed Place, Maple Grove, Minnesota, for stent finishing, inspection, and cleaning.
P060006|S075|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2016|08/11/2016|||APPR|Approval for a manufacturing site located at Boston Scientific, 2 Scimed Place, Maple Grove, Minnesota, for stent finishing, inspection, and cleaning.
P090003|S042|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||STENT, ILIAC|EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM|NIO|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2016|08/11/2016|||APPR|Approval for a manufacturing site located at Boston Scientific, 2 Scimed Place, Maple Grove, Minnesota, for stent finishing, inspection, and cleaning.
P130024|S013|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX 035 DRUG COATED BALLOON PTA CATETER|ONU|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/15/2016|11/09/2016|||APPR|Approval for a manufacturing site located at Lutonix Inc., 9409 Science Center Drive, New Hope, Minnesota to manufacture 7mm balloons.
P130021|S021|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE(R) EVOLUT R  SYSTEM|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2016|06/21/2016|||OK30|Removal of in-process tensile testing on the Flush Hub bond of the EnVeo R Delivery Catheter System.
P130013|S010|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|System, appendage closure, left atrial|WATCHMAN LEFT ATRIAL APPENDAGE  CLOSURE (LAAC) DEVICE|NGV|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/16/2016|06/28/2016|||APPR|Approval of an alternate material and supplier for the suture component of the device.
P160017||MEDTRONIC MINIMED|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325||Artificial pancreas device system, single hormonal control|MiniMed 670G System|OZP|CH|||Y|06/16/2016|09/28/2016|16M-1972|09/28/2016|APPR|MiniMed 670G SystemThe Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.The Medtronic MiniMed 670G System consists of the following devices: MiniMed 670G insulin pump, the Guardian Link (3) Transmitter, the Guardian Sensor (3), One-Press Serter, and the Contour NEXT Link 2.4 Glucose Meter. The system requires a prescription.The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian Sensor (3).Guardian Sensor (3)The Guardian Sensor (3) is intended for use with the MiniMed 670G system to continuously monitor glucose levels in persons with diabetes. It is intended to be used for detecting trends and tracking patterns in persons aged fourteen years and older, and to be used by the MiniMed 670G system to automatically adjust basal insulin levels. It is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. The Guardian Sensor (3) is indicated for 7 days of continuous use.One-press SerterThe One-press Serter is used as an aid for inserting the sensor. It is indicated for single-patient use and it is not intended for multiple-patient use.Guardian Link (3) Transmitter The Guardian Link (3) Transmitter is intended for use with the MiniMed 670G System. The Guardian Link (3) Transmitter powers the glucose sensor, collects and calculates sensor data, and wirelessly sends the data to the MiniMed 670G insulin pump. The Transmitter is intended for single-patient multi-use. Contour NEXT Link 2.4 Glucose MeterThe Contour Next Link 2.4 Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single patient use only and should not be shared. The Contour Next Link 2.4 wireless blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The Contour NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The Contour Next Link 2.4 wireless blood glucose monitoring system is intended to be used to transmit glucose values to the MiniMed 670G pump and facilitate transfer of information to Medtronic CareLink Software through the use of radio frequency communication. The Contour Next Link 2.4 Wireless Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for, diabetes mellitus. It is not intended for use on neonates.
P130028|S010|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2016|07/13/2016|||OK30|Acceptance of an alternate manufacturing site for the supplier of the Algovita IPG electrical connector components.
P970004|S217|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2016|07/13/2016|||OK30|Changes to tapering process for tubing used on leads from a manual tapering process to a semi-automated tapering process and replacement of a ring gauge outer diameter measurement system with a laser micrometer.
P080025|S112|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/16/2016|07/13/2016|||OK30|Changes to tapering process for tubing used on leads from a manual tapering process to a semi-automated tapering process and replacement of a ring gauge outer diameter measurement system with a laser micrometer.
P990023|S016|ALCON LABORATORIES|6201 South Freeway||Fort Worth|TX|76134||AID, SURGICAL, VISCOELASTIC|CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE|LZP|OP|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2016|09/09/2016|||APPR|Approval to replace the current product release intravitreal test with the inflammatory release assay (IRA) product release test.
P140003|S011|ABIOMED, INC.|22 CHERRY HILL DR.||DANVERS|MA|01923||Temporary non-roller type cardiac support blood pump|IMPELLA CP SYSTEM|OZD|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2016|11/03/2016|||APPR|Approval for modifying the inspection criteria for the pump housing component for the Impella CP device.
P020004|S133|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2016|07/11/2016|||OK30|Implementation of circumferential tensile testing as a lot acceptance test for the graft component of the GORE EXCLUDER Iliac Branch Endoprosthesis.
P060038|S028|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/17/2016|07/14/2016|||OK30|Introduction of an alternative verification test method used to verify the Isopropyl Alcohol (IPA) concentration of the sterilant solution.
P140010|S020|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/20/2016|07/08/2016|||OK30|Changes to the manufacturing and inspection processes for the catheter body sub-assembly.
P000058|S060|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT/Medtronic Interbody FUSION DEVICE|NEK|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2016|09/16/2016|||APPR|Approval for increasing the size of the bioreactor used to manufacture rhBMP-2 from 6000 L to 12,000 L at the Pfizer Andover, MA Facility.
P970004|S218|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2016|08/24/2016|||APPR|Approval for a manufacturing site for kitting operations.
P000054|S044|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction|INFUSE BONE GRAFT|MPW|OR|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2016|09/16/2016|||APPR|Approval for increasing the size of the bioreactor used to manufacture rhBMP-2 from 6000 L to 12,000 L at the Pfizer Andover, MA Facility.
P080025|S113|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL|EZW|GU|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2016|08/24/2016|||APPR|Approval for a manufacturing site for kitting operations.
P050053|S035|MEDTRONIC Inc.|1800 Pyramid Place||Memphis|TN|38132||Bone grafting material, dental, with biologic component|INFUSE BONE GRAFT|NPZ|DE|Normal 180 Day Track|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/21/2016|09/16/2016|||APPR|Approval for increasing the size of the bioreactor used to manufacture rhBMP-2 from 6000 L to 12,000 L at the Pfizer Andover, Massachusetts facility.
P070009|S017|OBTECH MEDICAL GMBH|LANDIS AND GYR STRASSE 1||ZUG||CH-63|6300|IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR|LTI|GU|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|06/21/2016|10/11/2016|||APPR|Approval for changes to the device labeling made as a result of the approval of the 5 year Post-Approval Study.
P110038|S012|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/21/2016|09/19/2016|||APPR|Approval for an alternate material and joining method for the delivery system secondary sheath (also referred to as the constraining sleeve).
P120005|S049|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|06/21/2016|09/16/2016|||APPR|Approval for updates to the G5 Mobile iOS App Software and G5 Mobile Transmitter Firmware for Dexcom’s G5 Mobile Continuous Glucose Monitoring System. The App is being modified to: backfill data from the CGM if there are data gaps within the last 3 hours; include mute override settings, which allow users to hear alerts critical to safe and effective use of the device even when their smart device is muted or turned to a very low volume; and to correct software anomalies. The Transmitter Firmware is being modified to: transmit data for backfill in the App; improve efficiency of battery usage on the transmitter; expand transmitter database logging to include additional information; support internal engineering efforts; and to correct software anomalies.
P130021|S022|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE(R) EVOLUT R SYSTEM|NPT|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/21/2016|08/26/2016|||APPR|Approval for modifying the dimensions of the screw gear component.
P030004|S011|EV3 NEUROVASCULAR|9775 Toledo Way||Irvine|CA|92618||Agent, injectable, embolic|ONYX LIQUID EMBOLIC SYSTEM|MFE|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/22/2016|09/20/2016|||APPR|Approval for minor packaging, sterilization and labeling changes to the Onyx 18 and 34 Kits.
P030054|S305|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUICKFLEX u, QUARTET|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|07/19/2016|||OK30|Alternate analytical testing laboratory for the identification testing of dexamethasone sodium phosphate for incoming monolithic controlled release devices.
P950022|S093|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|DURATA, OPTISURE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|07/19/2016|||OK30|Alternate analytical testing laboratory for the identification testing of dexamethasone sodium phosphate for incoming monolithic controlled release devices.
P960030|S045|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ISOFLEX OPTIM|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|07/19/2016|||OK30|Alternate analytical testing laboratory for the identification testing of dexamethasone sodium phosphate for incoming monolithic controlled release devices.
P960013|S082|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|07/19/2016|||OK30|Alternate analytical testing laboratory for the identification testing of dexamethasone sodium phosphate for incoming monolithic controlled release devices.
P980035|S467|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADVISA DR IPG; DR MRI IPG; SR MRI IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|07/20/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P090013|S228|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|07/20/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P010015|S302|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONSULTA, SYNCRA, VIVA CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|07/20/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P010032|S120|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/22/2016|09/15/2016|||APPR|Approval for a new optional accessory, the Lead and Extension Insertion Tool (Model 1803), for use with approved SJM Implantable Pulse Generators (IPGs) and compatible leads, extensions, and adapters.
P140009|S017|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO NEUROSTIMULATION SYSTEM|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|06/22/2016|09/15/2016|||APPR|Approval for a new optional accessory, the Lead and Extension Insertion Tool (model 1803), for use with approved SJM Implantable Pulse Generators (IPGs) and compatible leads, extensions, and adapters.
P000053|S065|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT|EZY|GU|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|08/30/2016|||APPR|Approval for changes to design documentation for the cuff assembly, pressure regulating balloon, and control pump.
P110013|S073|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE  INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/22/2016|07/21/2016|||OK30|Implementation of an alternate solvent in the stent pre-clean manufacturing process.
P970051|S148|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2016|07/21/2016|||OK30|Addition of automated slot cutting of the sorting ring for implant production.
P140015|S010|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Pump, infusion, insulin, to be used with invasive glucose sensor|T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2016|07/20/2016|||OK30|Automate the software loading process performed during manufacture of the t:slim G4 Insulin Pump at the Tandem Diabetes Care manufacturing plant in San Diego, CA. The t:slim G4 Insulin Pump is a component of the Dexcom G4 Platinum CGM System. The proposed change does not alter the device design, materials, or performance specifications. The change does not affect the labeling of the device.
P000015|S014|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Implant, auditory brainstem|NUCLEUS  AUDITORY BRAINSTEM IMPLANT|MHE|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2016|07/21/2016|||OK30|Addition of automated slot cutting of the sorting ring for implant production.
P010030|S078|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/23/2016|07/21/2016|||OK30|Change to the LifeVest 4000 Monitor burn-in test procedure.
P030022|S036|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR HIP SYSTEM|MRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|06/23/2016|07/22/2016|||APPR|Approval for a labeling change for the REFLECTION Ceramic Acetabular Hip System which also includes the R3 Ceramic Acetabular Hip System.
P950008|S013|ALCON|6201 SOUTH FREEWAY|MAIL DROP R7-14|FORT WORTH|TX|76134|2099|Fluid, intraocular|SILIKON 1000|LWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/18/2016|||OK30|Addition of a new biological indicator to be used as an alternate process challenge device (PCD) for terminal sterilization of SILIKON 1000.
P980035|S468|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA, VERSA, SENSIA IPG; ADVISA DR IPG; ADVISA DR MRI IPG; ADVISA SR MRI IPG; RELIA IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P010015|S303|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P890003|S358|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Elite, Elite II, Minuet, Preva, Preva D, Prodigy, Synergyst II, Thera, Thera-i, Analyzer, Vitatron Legacy, Vitatron Lega|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/06/2016|||APPR|Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
P830055|S172|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/22/2016|||APPR|Approval to add the ATTUNE Cementless Rotating Platform (RP) Tibial Bases to LCS Total Knee System.  The subject device adds POROCOAT porous coating to fixation surfaces of the previously approved ATTUNE Cemented RP Tibial Bases.
P970012|S099|MEDTRONIC Inc.|8200 Coral Sea Street NE||Mounds View|MN|55112||Pulse generator, permanent, implantable|Kappa 400|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/06/2016|||APPR|Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
P050039|S019|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|NOVATION CERAMIC ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/21/2016|||OK30|Addition of an extra sealer for the packaging process. The new equipment is intended for the sealing of packages for the acetabular liner and femoral head components and mating bone screw components used with the Exactech Novation Ceramic Articulation Hip System (AHS).
P030036|S085|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|SELECTSECURE LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P980016|S593|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EnTrust, Gem,Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Protecta DF4, Protecta, Protecta XT DF4 Prote|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/06/2016|||APPR|Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
P060039|S071|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN STARFIX MODEL 4195 LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P980035|S469|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Advisa, AT500, EnPulse, EnRhythm, Kappa 600, 650, 700, 800, 900; Relia, Sensia, Sigma, Versa|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/06/2016|||APPR|Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
P080006|S096|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD; ATTAIN PERFORMA LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P910023|S374|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|Current+ ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/19/2016|||OK30|Changes to the hybrid solder reflow process.
P030054|S306|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Promote + ICDS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/19/2016|||OK30|Changes to the hybrid solder reflow process.
P090013|S229|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG AND CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P990001|S122|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Diva family(includes Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR) Dema family, Selection A|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/06/2016|||APPR|Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
P020004|S134|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/11/2016|||OK30|Implementation of the manufacture of the 23mm and 27mm sizes of the GORE EXCLUDER AAA Endoprosthesis Contralateral Leg components at the Sunnyvale manufacturing facility.
P120017|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MYOCARDIAL PACING LEAD|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P010015|S304|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Consulta CRT-P, InSync, InSync III, Syncra CRT-P, Viva CRT-P|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/06/2016|||APPR|Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
P830061|S131|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P850089|S118|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P890003|S359|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2 LEAD, SERVICE KIT-PACEMAKER REPAIR KIT, VITATRON BRILLIANT S+ VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P010031|S554|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Concerto, Right Ventricular Lead Integrity Alert, Concerto II CRT-D. Consulta CRT-D, InSync II Marquis, II Protect, III|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/06/2016|||APPR|Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
P900061|S140|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|END CAP, UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P090013|S230|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Revo MRI, EnRhythm MRI|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/24/2016|09/06/2016|||APPR|Approval for enhancements to the Medtronic Model SW028 Baseline Operating System Software (BOSS) as well as the Vitatron Model VSH04 Desktop Application software running on the CareLink Encore 29901 Programmer.
P920015|S181|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD, TUNNEL|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P930039|S153|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P010031|S555|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|AMPLIA/BRAVA/CONCERTO/INSYNC SENTRY/INSYNC MAXIMO/PROTECTA/VIVA IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC R|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P950024|S068|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE EPICARDIAL PACING LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P980016|S594|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|EVERA MRI/EVERA S DR/EVERA S VR/EVERA XT DR/EVERA XT VR/MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRT|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P980050|S105|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/24/2016|07/14/2016|||OK30|Implementation of a peel strength test to the manufacturing process.
P890003|S360|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MEDTRONIC CARELINK ENCORE 29901 PROGRAMMER|NVZ|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/27/2016|08/11/2016|||APPR|Approval for updated hardware components, minor mechanical changes, and corresponding software updates to the computing platform.
P860022|S059|POLYMER TECHNOLOGY CORP.|1400 N. GOODMAN ST.||ROCHESTER|NY|14692||Lens,contact(rigid gas permeable)-extended wear|BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS|MWL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/25/2016|||OK30|Alternate supplier of a critical raw material component.
P140018|S002|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||Agent, occluding, vascular, permanent|VENASEAL CLOSURE SYSTEM|PJQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/27/2016|||OK30|Implementation of an alternative test method for determination of Butylated hydroxyanisole (BHA) in the n-butyl cyanoacrylate (nBCA) monomer at incoming inspection as well as in the VenaSeal adhesive formulation.
P010062|S010|BAUSCH & LOMB|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14603|0450|Lens, contact, orthokeratology, overnight|BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT|NUU|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/25/2016|||OK30|Alternate supplier of a critical raw material component.
P020056|S034|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Real-Time Process|Change Design/Components/Specifications/Material|N|06/27/2016|09/22/2016|||APPR|Approval for Inspira Cohesive Silicone-Filled Breast Implants filled with highly cohesive silicone gel.
P840001|S333|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, ltrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimula|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/27/2016|||OK30|Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.
P860004|S254|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED(TM) INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/27/2016|||OK30|Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.
P960009|S255|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|Activa Deep Brain Stimulation Therapy System|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/27/2016|||OK30|Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.
P970004|S219|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/27/2016|||OK30|Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.
P080025|S114|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/27/2016|||OK30|Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.
P010012|S425|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ACUITY SPIRAL LEAD, ACUITY X4 LEAD|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/25/2016|||OK30|Change in a reactant used for preparation of the key intermediate in the synthesis of dexamethasone acetate.
P910073|S136|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/25/2016|||OK30|Change in a reactant used for preparation of the key intermediate in the synthesis of dexamethasone acetate.
P840001|S334|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume,Specify, and Vectris Spinal Cord Stimulat|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/20/2016|||OK30|Implementation of peel strength testing in the manufacturing lines at Medtronic Puerto Rico Operations Co. Villalba and Medtronic Puerto Rico Operations Juncos.
P860004|S255|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/20/2016|||OK30|Implementation of peel strength testing in the manufacturing lines at Medtronic Puerto Rico Operations Co. Villalba and Medtronic Puerto Rico Operations Juncos.
P150012|S009|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGEVITY LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/25/2016|||OK30|Change in a reactant used for preparation of the key intermediate in the synthesis of dexamethasone acetate.
P960009|S256|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA Deep Brain Stimulation Therapy System|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/20/2016|||OK30|Implementation of peel strength testing in the manufacturing lines at Medtronic Puerto Rico Operations Co. Villalba and Medtronic Puerto Rico Operations Juncos.
P970004|S220|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/20/2016|||OK30|Implementation of peel strength testing in the manufacturing lines at Medtronic Puerto Rico Operations Co. Villalba and Medtronic Puerto Rico Operations Juncos.
P080025|S115|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/20/2016|||OK30|Implementation of peel strength testing in the manufacturing lines at Medtronic Puerto Rico Operations Co. Villalba and Medtronic Puerto Rico Operations Juncos.
P960040|S375|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Dynagen™ Models: D020, D021, D022, D023; D150, D151, D152, D153; Inogen™ Models: D010, D011, D012, D013, D140, D141, D14|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/22/2016|||OK30|Modifications to the battery weld process.
P010012|S426|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Dynagen™ Models: G150, G151, G154, G156, G158; Inogen™ Models: G140, G141, G146, G148; Origen™|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/27/2016|07/22/2016|||OK30|Modifications to the battery weld process.
P860004|S256|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED II INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2016|07/28/2016|||OK30|Add additional monitor to the SynchroMed II propellant backfill plug weld process for hardness and penetration specifications.
P030031|S075|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|ThermoCool SmartTouch Uni-Directional Navigation Catheter|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2016|07/18/2016|||OK30|Use of new equipment, the Output Control System, to inspect connectivity of force and navigation sensor coils, the data on the device EEPROM, and compare EEPROM information as well as physical attributes against the Work Order Packet Requirements.
P150013|S002|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC 22C3 PHARMDX|PLS|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|06/28/2016|09/23/2016|||APPR|Approval for addition of the Dako PT Link PT200 programmable water bath for pre-treatment of tissue sections when using PD-L1 IHC 22C3 pharmDx.
P040036|S056|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/28/2016|07/18/2016|||OK30|Use of new equipment, the Output Control System, to inspect connectivity of force and navigation sensor coils, the data on the device EEPROM, and compare EEPROM information as well as physical attributes against the Work Order Packet Requirements.
P100040|S026|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2016|07/29/2016|||OK30|Stent graft edge trimming process change for the Valiant Thoracic Stent Graft.
P980044|S033|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ Device Family, Supartz FX, VISCO-3|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2016|07/25/2016|||OK30|Update the application software for the existing intrinsic viscosity measuring system used for the manufacture of SUPARTZ FX and VISCO-3.
P030017|S253|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD, SPECTRA, NOVI, MONTAGE MRI & PRECISION MONTAGE SPINAL CORD  STIMULATION(SCS) SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2016|07/28/2016|||OK30|Suppliers change in site of manufacture of the Stylet Cap Cover component used with Infinion CX Leads.
P980035|S470|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Versa, Sensia IPG AND  Relia IPG|NVZ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/29/2016|09/22/2016|||APPR|Approval for an alternate Hall sensor integrated circuit used in the Adapta, Versa, Sensia, and Relia families of IPG devices.
P150016|S001|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|TRIDYNE VASCULAR SEALANT|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/29/2016|07/27/2016|||OK30|Expansion of the cleanrooms used in the manufacture of Tridyne Vascular Sealant at the existing location, 60 Technology Drive, Irvine, California.
P960013|S083|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL ST, STS AND OPTISENSE LV LEADS|NVN|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|06/30/2016|09/26/2016|||APPR|Approval for changes to the front seal dimensions of the Tendril ST, STS and OptiSense LV leads.
P110020|S016|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|06/30/2016|11/07/2016|||APPR|Approval for the cobas® 4800 BRAF V600 Mutation Test.  The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas® 4800 System, and is intended to be used as an aid in selecting melanoma patients for treatment with the targeted therapies listed in the table below, in accordance with the approved therapeutic product labeling: Therapeutic	Therapeutic Indication	Test ResultZELBORAF® (vemurafenib)	BRAF V600E	Mutation DetectedCOTELLIC® (cobimetinib), in combination with ZELBORAF® (vemurafenib)	BRAF V600E or V600K*	Mutation Detected* *Due to cross-reactivity by the cobas® 4800 BRAF V600 Mutation Test, the clinical trial for cobimetinib, in combination with vemurafenib, included some patients whose tumor carried the BRAF V600K mutation.
P840001|S335|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Lead|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2016|07/29/2016|||OK30|Use of new capacitors and diodes for the manufacture of hybrid assemblies that are used on several Medtronic Neuromodulation implantable neurostimulators (INS).
P960009|S257|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|Activa Deep Brain Stimulation Therapy System|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2016|07/29/2016|||OK30|Use of new capacitors and diodes for the manufacture of hybrid assemblies that are used on several Medtronic Neuromodulation implantable neurostimulators (INS).
P860004|S257|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|ASCENDA INTRATHECAL CATHETERS AND KITS|LKK|HO|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|06/30/2016|09/27/2016|||APPR|Approval for labeling changes for Medtronics Ascenda Intrathecal Catheter and Revision Kit including: Implant Manuals  Catheter Length Measurement; Implant Manuals  Materials Table; Implant Manuals  Verb change; Implant Manuals Reference to Model 8784 Kit added; Implant Manuals Other clarification, administrative and style changes; Package Labels  Catheter Length Measurements; Package Labels  Addition of symbols; Package Labels  Other minor changes. These changes impact the manuals associated with the following models: Full Catheter Kit  8780 Ascenda Intrathecal Catheter (86cm spinal segment); Full Catheter Kit  8781 Ascenda Intrathecal Catheter (66cm spinal segment); Revision Catheter Kit  8782 Ascenda Intrathecal Catheter (86cm spinal segment revision kit); Revision Catheter Kit  8784 Ascenda Intrathecal Catheter (74cm spinal segment revision kit); Revision Catheter Kit  8785 Ascenda Accessory Kit. These changes impact the packaging labels associated with the following labels: Model 8780 Implant Manual; Model 8781 Implant Manual; Model 8782 Implant Manual; Model 8784 Implant Manual; Model 8780 Package Label; Model 8781 Package Label; Model 8782 Package Label; Model 8784 Package Label; Model 8785 Package Label.
P080020|S021|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|06/30/2016|07/25/2016|||OK30|Update the application software for the existing intrinsic viscosity measuring system used for the manufacture of Gel-One.
P130009|S061|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|06/30/2016|08/02/2016|||APPR|Approval of the following changes to the post-approval study for the device:  minor editorial changes and updates to contact information.
P100024|S010|DAKO DENMARK A/S|42 PRODUKTIONSVEJ|DK-2600|GLOSTRUP||DK-26|2600|Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|HER2 CISH PHARMDX KIT|NYQ|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2016|09/27/2016|||APPR|Approval for the DakoLink software version 4.1 update for the HER2 CISH pharmDx Kit
P060040|S060|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/01/2016|09/29/2016|||APPR|Approval for mechanical and marking modifications to the System Controller and Percutaneous Cable.
P020024|S046|AGA MEDICAL CORP.|5050 Nathan Lane North||Plymouth|MN|55442||OCCLUDER, PATENT DUCTUS, ARTERIOSUS|AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II|MAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|08/04/2016|||OK30|Change to the pre-sterilization bioburden action and alert levels.
P000039|S056|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal Occluder|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|08/04/2016|||OK30|Change to the pre-sterilization bioburden action and alert levels.
P040040|S029|St. Jude Medical Cardiovascular Division|5050 Nathan Lane North||Plymouth|MN|55442||Transcatheter septal occluder|AMPLATZER MUSCULAR VSD OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|08/04/2016|||OK30|Change to the pre-sterilization bioburden action and alert levels.
P040021|S029|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT)|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|07/26/2016|||OK30|Addition of three new bovine and porcine tissue suppliers.
P980016|S595|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Visia AF MRI VR ICD DVFB1D4, DVFC3D4; Visia AF VR ICD DVAB1D1, DVAB1D4|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|07/28/2016|||OK30|Update to the distribution control sorter tool system.
P100029|S022|St. Jude Medical, Inc.|177 E.COUNTY RD. B EAST||ST PAUL|MN|55117||heart-valve, non-allograft tissue|BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT)|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|07/26/2016|||OK30|Addition of three new bovine and porcine tissue suppliers.
P020004|S135|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|07/29/2016|||OK30|Implementation of a replicate manufacturing process for wrapped components of the GORE EXCLUDER AAA Endoprosthesis in Gore's Sunnyvale facility.
P010031|S556|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Compia MRI CRT-D DTMC1D4; Compia MRI Quad CRT-D DTMC1QQ|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|07/28/2016|||OK30|Update to the distribution control sorter tool system.
P150033|S004|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|Micra Transcatheter Pacing System MC1VR01|PNJ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|07/28/2016|||OK30|Update to the distribution control sorter tool system.
P970003|S201|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|07/29/2016|||OK30|Removal of the bead blast process from the standard final generator production process and retaining it as an optional process for processing generator cans that do not meet visual acceptance criteria.
P030017|S254|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION,  SPECTRA, NOVI, SPINAL CORD STIMULATION(SCS) SYSTEM; PRECISION MONTAGE MRI AND MONTAGE SPINAL CORD STIMULATOR|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/01/2016|07/29/2016|||OK30|Change in the manufacturing process to integrate two tests into one test system.
P070014|S051|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|BARD LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/01/2016|08/31/2016|||APPR|Approval of the post-approval study protocol.
P110042|S060|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|Emblem SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2016|08/19/2016|||APPR|Approval for a change to the acceptance criteria for a molded component.
P960040|S376|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Dynagen EL & Mini, Inogen EL & Mini, Origen EL & MIni IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2016|08/19/2016|||APPR|Approval for a change to the acceptance criteria for a molded component.
P010012|S427|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Dynagen & X4, Inogen & X4, Origen & X4 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/01/2016|08/19/2016|||APPR|Approval for a change to the acceptance criteria for a molded component.
P130009|S062|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|07/01/2016|08/19/2016|||APPR|Approval for various changes to the post-approval study protocol for the continued follow-up of the IDE Nested Registry #3.
P850007|S035|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|Spinal-Stim|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2016|12/02/2016|||APPR|Approval for a new fabric, modifications to the control unit housing, modifications to enlarge the Liquid Crystal Display (LCD), a change from a three-cell lithium-ion battery to a single lithium-ion battery, a change in the Printed Circuit Assembly (PCA), a modification to include a smaller power supply, updates to device firmware, a new iOS mobile application, and minor updates to labeling. The modified devices will be marketed under the trade names Spinal-Stim Model 5212 and Cervical-Stim Model 5505.
P010030|S079|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR (WCD) 4000|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2016|08/03/2016|||OK30|Use of an intermediate supplier to purchase device components and supply them to ZOLL.
P030034|S009|Orthofix, Inc.|3451 Plano Parkway||Lewisville|TX|75056||Stimulator, bone growth, non-invasive|Cervical-Stim|LOF|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2016|12/02/2016|||APPR|Approval for a new fabric, modifications to the control unit housing, modifications to enlarge the Liquid Crystal Display (LCD), a change from a three-cell lithium-ion battery to a single lithium-ion battery, a change in the Printed Circuit Assembly (PCA), a modification to include a smaller power supply, updates to device firmware, a new iOS mobile application, and minor updates to labeling. The modified devices will be marketed under the trade names Spinal-Stim Model 5212 and Cervical-Stim Model 5505.
P130008|S014|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II IMPLANTABLE PULSE GENERATOR|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2016|08/03/2016|||OK30|Implementation of additional peel strength testing for the Model 3024 Implantable Pulse Generator (IPG) at the contract manufacturer Medtronic MPROC Juncos Puerto Rico.
P910023|S375|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|FORTIFY ASSURA VR, FORTIFY ASSURA DR|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2016|09/06/2016|||APPR|Approval for a minor design modification to the vibratory patient notifier.
P030054|S307|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|UNIFY ASSURA, QUADRA ASSURA|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2016|09/06/2016|||APPR|Approval for a minor design modification to the vibratory patient notifier
P150012|S010|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGEVITY MRI LEAD, INGEVITY Non-MRI Lead|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2016|07/26/2016|||OK30|Modified welding fixture for use in the manufacturing of the Ingevity family of pacemaker leads.
P030054|S308|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QUARTET CRT LEADS|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2016|08/01/2016|||OK30|Assembly and inspection process changes during lead manufacturing.
P130024|S014|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX 035 DRUG COATED BALLOON PTA CATETER|ONU|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/05/2016|11/14/2016|||APPR|Approval for a shelf life extension from 24 to 36 months.
P140013|S003|MINERVA SURGICAL|101 SAGINAW DRIVE||REDWOOD CITY|CA|94063||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MINERVA ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Real-Time Process|Change Design/Components/Specifications/Material|N|07/05/2016|09/21/2016|||APPR|Approval for the addition of two gas shutoff solenoid valves and the implementation of a thermally bonded manifold module.
P130009|S063|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|Edwards Expandable Introducer Sheath Set|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2016|07/21/2016|||OK30|Modifications to the UV curing manufacturing process for the eSheath.
N970012|S117|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2016|08/03/2016|||OK30|Quality control changes related to InhibiZone formulation including reduction of test samples, change in detection method from HPLC to UPLC, and change in facility conducting test.
P000053|S066|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2016|08/03/2016|||OK30|Quality control changes related to InhibiZone formulation including reduction of test samples, change in detection method from HPLC to UPLC, and change in facility conducting test.
P110023|S020|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM ,EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/05/2016|08/02/2016|||OK30|Addition of new stent processing equipment.
P020004|S136|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA ENDOPROSTHESIS|MIH|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/07/2016|09/22/2016|||APPR|Approval for an alternate colorant to be used for components of the AAA Device C3 Delivery System and IBE Device Delivery System
P150025|S001|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION)|PLS|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/07/2016|10/05/2016|||APPR|Approval for addition of the PT Link PT200 for pre-treatment of tissue sections prior to staining with PD-L1 IHC 28-8 pharmDx.
P150027|S001|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)|PLS|PA|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|07/07/2016|10/05/2016|||APPR|Approval for addition of the PT Link PT200 for pre-treatment of tissue sections prior to staining with PD-L1 IHC 28-8 pharmDx.
P960040|S377|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DYNAGEN, INOGEN, ORIGEN ICD'S|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/02/2016|||OK30|Changes to the molding manufacturing line.
P010012|S428|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ACUITY X4 STRAIGHT, SPIRAL, SPIRAL L ; DYNAGEN, INOGEN, ORIGEN CRT-D'S|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/02/2016|||OK30|Changes to the molding manufacturing line.
P030022|S037|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC Acetabular Hip SYSTEM (RCHS)|MRA|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|10/04/2016|||APPR|Approval for packaging change to the SYNERGY, SPECTRON, and ANTHOLOGY hip stems used as part of the subject PMA device; REFLECTION Ceramic Hip System.
N970003|S191|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE,ALTRUA 2 PACEMAKER'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/02/2016|||OK30|Changes to the molding manufacturing line.
P030005|S139|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/02/2016|||OK30|Changes to the molding manufacturing line.
P010012|S429|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|DYNAGEN™ CRT-D: G150, G151, G154; DYNAGEN™ X4 CRT-D: G156, G158; INOGEN™ CRT-D: G140, G141; INOGEN™ X4 CRT-D: G146, G148|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/01/2016|||OK30|Alternate supplier of the titanium raw material used for capacitor can manufacturing.
P110042|S061|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/02/2016|||OK30|Changes to the molding manufacturing line.
P960040|S378|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|DYNAGEN™ EL ICD: D150, D151, D152, D153; INOGEN™ EL ICD: D140, D141, D142, D143; ORIGEN™ EL ICD: D050, D051, D052, D053;|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/01/2016|||OK30|Alternate supplier of the titanium raw material used for capacitor can manufacturing.
P960004|S077|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|FINELINE II|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/02/2016|||OK30|Changes to the molding manufacturing line.
P910073|S137|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE 4-SITE LEADS PASSIVE FIXATION & ENDOTAK RELIANCE 4-SITE ACTIVE FIXATION|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/02/2016|||OK30|Changes to the molding manufacturing line.
P150012|S011|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI PACEMAKER'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/02/2016|||OK30|Changes to the molding manufacturing line.
P130026|S021|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TACTICATH QUARTZ SET|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/07/2016|08/03/2016|||OK30|Addition of an alternate supplier for proximal fiber optic components.
P970004|S221|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/2016|08/05/2016|||APPR|Approval for changes to the labeling to correct and modify instructions regarding the use of the cycling feature and its impact on battery longevity.
P080025|S116|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM FOR BOWEL|EZW|GU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/2016|08/05/2016|||APPR|Approval for changes to the labeling to correct and modify instructions regarding the use of the cycling feature and its impact on battery longevity.
P100010|S058|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM: 23MM AND 28MM ARCTIC FRONT CATHETERS, FREEZOR MAX CATHETER, CRYOCONSOLE, MANUA|OAE|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/08/2016|08/31/2016|||APPR|Approval of the following changes to the post-approval study for the device: reduce the follow-up period from 5 years to 3 years and terminate the study after all subjects have had 3 years of follow-up and the primary endpoint has been reached.
P030050|S025|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|SCULPTRA AND SCULPTRA AESTHETIC|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/08/2016|07/22/2016|||APPR|Approval for labeling changes related to the risks associated with intravascular injection of soft tissue fillers.
P050028|S052|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TAQMAN HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Addition of a new fermenter used in the manufacturing process for enzymes.
P150015|S003|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Addition of a new fermenter used in the manufacturing process for enzymes.
P150014|S003|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS HBV TEST|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Addition of a new fermenter used in the manufacturing process for enzymes.
P140023|S006|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS KRAS MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Equipment change.
P120019|S010|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Equipment change.
P110020|S017|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Equipment change.
P060030|S052|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS TAQMAN HCV|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Addition of a new fermenter used in the manufacturing process for enzymes.
P100020|S020|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/05/2016|||OK30|Addition of a new fermenter used in the manufacturing process for enzymes.
P110037|S027|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Addition of a new fermenter used in the manufacturing process for enzymes.
P000012|S056|Roche Molecular Systems, Inc.|4300 HACIENDA DR.||PLEASANTON|CA|94588|0900|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLICOR HCV|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/08/2016|08/04/2016|||OK30|Addition of a new fermenter used in the manufacturing process for enzymes.
P000037|S046|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2016|07/25/2016|||OK30|Use of an additional Coordinate Measuring Machine for heart valve housing measurements.
P000058|S061|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|LT-CAGE LUMBAR TAPERED/INTER FIX THREADED/INTER FIX RP THREADED/PERIMETER INTERBODY FUSION DEVICE, CLYDESDALE SPINAL SYS|NEK|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2016|08/11/2016|||OK30|Site change for a manufacturing supplier.
P060023|S005|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|BRYAN CERVICAL DISC SYSTEM|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2016|08/11/2016|||OK30|Site change for a manufacturing supplier.
P060018|S005|MEDTRONIC SOFAMOR DANEK, INC.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE CERVICAL DISC SYSTEM|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2016|08/11/2016|||OK30|Site change for a manufacturing supplier.
P090029|S005|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||PROSTHESIS, INTERVERTEBRAL DISC|PRESTIGE LP CERVICAL DISC SYSTEM|MJO|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2016|08/11/2016|||OK30|Site change for a manufacturing supplier.
P010032|S122|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI LE CHARGING SYSTEM AND PRODIGY CHARGER SYSTEM|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2016|10/04/2016|||APPR|Approval for a design change to the charger wand used to charge rechargeable implantable pulse generators.
P140009|S019|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO LE CHARGING SYSTEM|MHY|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2016|10/04/2016|||APPR|Approval of a design change to the charger wand used to charge rechargeable implantable pulse generators.
P150023|S001|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||Absorbable coronary drug-eluting stent|ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM|PNY|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/11/2016|10/07/2016|||APPR|Approval for a shelf life extension from 12 months to 18 months for the small scaffold design (2.5 and 3.0mm diameters), and the implementation of an alternate temperature monitoring system.
P140015|S011|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Pump, infusion, insulin, to be used with invasive glucose sensor|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM|OYC|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/11/2016|10/04/2016|||APPR|Approval for modifications to the fuel gauge register to change the how the t:slim G4 System reads the battery level.
P990046|S047|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT HEART VALVE & OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/11/2016|08/04/2016|||OK30|Update to software used in the manufacturing process for the Open Pivot Heart Valve and Aortic Valved Graft.
P050050|S010|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, ankle, uncemented, non-constrained|SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE)|NTG|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2016|09/28/2016|||APPR|Approval for the use of three specific saw blades in the S.T.A.R. ankle surgical technique.
P140015|S012|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Pump, infusion, insulin, to be used with invasive glucose sensor|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|OYC|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/12/2016|10/04/2016|||APPR|Approval for design and manufacturing changes to implement an alternative Screen On/Quick Bolus button on the t:slim G4 Insulin Pump.  The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM System.
P960053|S005|STRYKER CORPORATION|BOHNACKERWEG 1||SELZACH||CH 25||Prosthesis, finger, constrained, metal/polymer|BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS|KWG|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2016|08/09/2016|||APPR|Approval of changes to the device labeling.
P140028|S015|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/09/2016|||OK30|Changes to the stent processing.
P130028|S011|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/12/2016|||OK30|Addition of 1) supplemental functional inspection; and 2) regular monitoring process of non-implantable electronic devices with integral batteries.
P050019|S025|Boston Scientific Corp.|2011 STIERLIN CT.||MOUNTAIN VIEW|CA|94043|4655|STENT, CAROTID|CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS|NIM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Vendor changes for a resin used in the manufacturing of the stent delivery catheters.
P970003|S202|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS;  VNS THERAPY PERENNIAD|LYJ|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2016|08/12/2016|||APPR|Approval for labeling changes to address adverse events (AE) associated with the VNS stimulation following electrical cardioversion procedures.
N18033|S082|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON(etafilcon A) brand contact lenses|LPM|OP|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/13/2016|08/10/2016|||APPR|Approval for labeling modifications to the device.
P060006|S076|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Vendor changes for a resin used in the manufacturing of the stent delivery catheters.
P890003|S361|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Medtronic Express Monitor|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2016|09/12/2016|||APPR|Approval for an iOS version of the Carelink Express mobile app.
P980016|S596|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI/S DR/S VR/XT DR/XT VR, Intrinsic 30, Marquis VR, Maximo II, Protecta/Protecta VR/XT,  Secura/Secura DR, Virtuo|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2016|09/12/2016|||APPR|Approval for an iOS version of the Carelink Express mobile app.
P980035|S471|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta/Versa/Sensia, Advisa DR/DR MRI/SR MRI, EnPulse E1/E2, Kappa DR (Kappa 700/600, 900/800)/VDD (Kappa 700) families|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2016|09/12/2016|||APPR|Approval for an iOS version of the Carelink Express mobile app.
P010015|S305|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Consulta, Syncra, and Viva CRT-Ps|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2016|09/12/2016|||APPR|Approval for an iOS version of the Carelink Express mobile app.
P010031|S557|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI/MRI Quad, Brava/Brava Quad, Compia MRI/MRI Quad, Concerto/Concert II, Consulta, Maximo II, Protecta/Protecta|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2016|09/12/2016|||APPR|Approval for an iOS version of the Carelink Express mobile app.
P090013|S231|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Revo MRI SureScan IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/13/2016|09/12/2016|||APPR|Approval for an iOS version of the Carelink Express mobile app.
P980049|S115|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|PLATINIUM VR 1210/1240, PLATINIUM DR 1510/1540 (ICD)|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/09/2016|||OK30|Add a second sterilizer for Platinium devices.
P060027|S081|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PLATINIUM CRT-D 1711/1741|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/09/2016|||OK30|Add a second sterilizer for Platinium devices.
P030009|S088|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|Integrity CORONARY STENT SYSTEMS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P110013|S074|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P090006|S018|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, ILIAC|COMPLETE SE VASCULAR STENT SYSTEM Iliac|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P110040|S010|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||STENT, SUPERFICIAL FEMORAL ARTERY|MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM SFA and PPA|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P110011|S012|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, ILIAC|ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P100040|S027|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|VALIANT THORACIC STENT GRAFT SYSTEM W/ the Captivia Delivery System|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P100021|S055|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|MEDTRONIC ENDURANT STENT GRAFT SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P070027|S047|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|TALENT Occluder W Occluder Delivery System|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P130021|S023|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|MEDTRONIC COREVALVE SYSTEM and Medtronic CoreValve Evolut R System|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P140010|S021|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-Coated PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/13/2016|08/10/2016|||OK30|Implement an electronic laboratory management system.
P980049|S116|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|Platinium VR 1210; Platinium VR 1240; Platinium DR 1510; Platinium DR 1540|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2016|08/08/2016|||OK30|Use of the Automated Optical Inspection equipment during the microelectronic and electronic assembly manufacturing.
P060027|S082|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Platinium CRT-D 1711; Platinium CRT-D 1741|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2016|08/08/2016|||OK30|Use of the Automated Optical Inspection equipment during the microelectronic and electronic assembly manufacturing.
P130017|S011|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/14/2016|07/26/2016|||OK30|Qualification of a new water system.
P110010|S128|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/10/2016|||OK30|Software change to the platinum chromium alloy (PCA) wetline used for production of uncoated stent components at the Galway, Ireland; Plymouth, Minnesota; and Maple Grove, Minnesota facilities.
P150003|S016|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/10/2016|||OK30|Software change to the platinum chromium alloy (PCA) wetline used for production of uncoated stent components at the Galway, Ireland; Plymouth, Minnesota; and Maple Grove, Minnesota facilities.
P130030|S025|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM Monorail & OTW|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/10/2016|||OK30|Software change to the platinum chromium alloy (PCA) wetline used for production of uncoated stent components at the Galway, Ireland; Plymouth, Minnesota; and Maple Grove, Minnesota facilities.
P120005|S051|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM/DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/12/2016|||OK30|Extending the temperature excursion period for the Dexcom G5 Mobile/G4 PLATINUM Sensor. The proposed change seeks to extend the allowable temperature excursion period for the sensor component in its primary packaging.  The Dexcom G5 Mobile/G4 PLATINUM Sensor is a component of the Dexcom G5 Mobile and the Dexcom G4 Platinum Continuous Glucose Monitoring System, respectively.
P970003|S203|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|VNS THERAPY SYSTEM|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/12/2016|||OK30|Addition of an alternate automated proofreading system for receiving inspection of printed labeling materials at the Houston manufacturing facility.
N16895|S098|Bausch & Lomb, Inc.|1400 NORTH GOODMAN ST.||ROCHESTER|NY|14609|3547|Lenses, soft contact, extended wear|SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/12/2016|||OK30|Relocation of twelve manufacturing lines.
N18033|S083|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (etafilcon A) Brand Contact Lenses|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/08/2016|||OK30|Implement changes to the method of adjusting the monomer dose level target of the monomer dose system for the VISTAKON® (etafilcon A) Brand Contact Lenses.
N970003|S192|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ALTRUA, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/10/2016|||OK30|Changes to an acceptance limit and sampling rate during battery testing.
P030005|S140|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE CRT-P, ACCOLADE CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/10/2016|||OK30|Changes to an acceptance limit and sampling rate during battery testing.
P890003|S362|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MYCARELINK PATIENT MONITOR, MYCARELINK READER FIELD REPLACEMENT UNIT (FRU), MYCARELINK SMART PATIENT READER, CARELINK EN|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/15/2016|08/10/2016|||OK30|Updates to the final assembly process for monitors and programmers.
P870076|S023|Gyrus ACMI, Inc.|136 TURNPIKE RD.||SOUTHBOROUGH|MA|01772||Laparoscopic contraceptive tubal occlusion device|Falope-Ring Band Contraceptive Tubal Occlusion System|KNH|OB|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2016|09/23/2016|||APPR|Approval for a change in the material used to thermoform the tray and tray insert from Verex 5400, to Polyethylene Terephthalate Glycol (PETG).
P030036|S086|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|SELECTSECURE LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2016|08/15/2016|||OK30|Change in supplier for a molded component used in lead manufacturing.
P010047|S043|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2016|08/17/2016|||OK30|Addition of a particulate matter quality checks at various stages of the Progel manufacturing process.
P980037|S058|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SET'S|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/18/2016|08/18/2016|||OK30|Manufacturing changes to the Angiojet production line.
P910073|S138|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE 4-SITE, Defibrillation Lead Family ,Active Fixation Models (New): 0272, 0273. Passive Fixation Models (|LWS|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/18/2016|09/29/2016|||APPR|Approval for a line extension for silicone backfilled coils.
P040043|S086|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2016|08/18/2016|||OK30|Implement the use of new raw material resins for use in Conformable TAG Thoracic (CTAG) catheter components.
P830055|S173|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS TOTAL KNEE SYSTEM|NJL|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|07/19/2016|10/12/2016|||APPR|Approval for the addition of the ATTUNE INTUITION Reusable Instruments to the ATTUNE Cementless implants.
P070026|S038|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2016|09/21/2016|||OK30|Addition of already approved sterilization site (for other components of the PMA device) for the Pinnacle cups.
P070026|S039|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2016|09/21/2016|||OK30|Addition of already approved sterilization site (for other components of the PMA device) for the Pinnacle cups.
P890055|S063|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|Medstream Programmable Infusion System|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2016|08/18/2016|||OK30|Move downstream manufacturing processes from the Medos International facility located at Chemin Blanc, Le Locle, Switzerland to Codman Neuro Sciences located at Rue Girardet, Le Locle, Switzerland.
P140010|S022|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN.PACT ADMIRAL PACLITAXEL-COATED BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2016|08/04/2016|||OK30|Alternate incoming inspection method to determine the API identity.
P050028|S053|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS AmpliPrep/Cobas TAQMAN HBV TEST and Cobas TaqMan HBV Test for user with The High Pure System|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2016|08/18/2016|||OK30|Change in resin used to manufacture a plastic consumable used with the device.
P060030|S053|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2016|08/18/2016|||OK30|Change in resin used to manufacture a plastic consumable used with the device.
P110037|S028|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/19/2016|08/18/2016|||OK30|Change in resin used to manufacture a plastic consumable used with the device.
P040024|S091|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE / PERLANE INJECTABLE GEL|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2016|08/15/2016|||OK30|Change in the manufacturing site of 0.9% sodium chloride (NaCl)-solution.
P120006|S025|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2016|08/17/2016|||OK30|Implementation of a revised welding program and modification to the weld flange orientation which is used in the manufacturing of the Ovation Abdominal Stent Graft System.
P840001|S336|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify,  and Vectris Spinal Cord Stimul|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/20/2016|08/18/2016|||OK30|Implementation of select repackaging and relabeling activities on Spinal Cord Stimulation MRI Surgical leads that are returned to Medtronics Memphis Distribution Center.
P030017|S255|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM; MRI SPINAL CORD STIMULATOR (SCS) SYSTEM.|LGW|NE|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/2016|10/18/2016|||APPR|Approval for an alternate qualified supplier for the coil connector used in the above referenced implantable pulse generators (IPGs), as well as minor design changes to the coil connector and the connector block to accommodate the new supplier manufacturing process.
P930014|S092|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0|HQL|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|07/20/2016|10/12/2016|||APPR|Approval for modifications to your real time shelf life protocol to substitute the aerosol microbial challenge test with the microbial barrier test and to add a seal strength test for your AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-Loaded Delivery System, Model AU00T0.
P980049|S117|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DR|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2016|09/27/2016|||APPR|Approval for Remote Monitoring System software version 3.7.
P900056|S154|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|ROTABLATOR Rotational Atherectomy System|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/10/2016|||OK30|Sterilize the devices with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P120010|S092|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/15/2016|||OK30|Additional plasma equipment used during manufacture of the Enlite sensor component at the Medtronic’s sensor substrate supplier, Metrigraphics LLC.
P150019|S017|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/15/2016|||OK30|Additional plasma equipment used during manufacture of the Enlite sensor component at the Medtronic’s sensor substrate supplier, Metrigraphics LLC.
P920047|S094|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|BLAZER II CARDIAC ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/11/2016|||OK30|Sterilize the devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P150029|S001|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|IPRO2 CGM SYSTEM WITH ENLITE SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/15/2016|||OK30|Additional plasma equipment used during manufacture of the Enlite sensor component at the Medtronic’s sensor substrate supplier, Metrigraphics LLC.
P060027|S083|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2016|09/27/2016|||APPR|Approval for Remote Monitoring System software version 3.7.
P950029|S111|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|Reply Sr, Reply DR, Esprit SR, Esprit DR Pacemakers|DXY|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/21/2016|09/27/2016|||APPR|Approval for Remote Monitoring System software version 3.7.
P980003|S068|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI COOLED ABLATION CATHETER AND CABLE|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/11/2016|||OK30|Sterilize the devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P020009|S128|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|EXPRESS 2 MR & OTW|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/10/2016|||OK30|Sterilize the devices with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P020025|S090|BOSTON SCIENTIFIC|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/11/2016|||OK30|Sterilize the devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P060006|S077|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/11/2016|||OK30|Sterilize the devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P110010|S129|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/10/2016|||OK30|Sterilize the devices with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P130030|S026|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/10/2016|||OK30|Sterilize the devices with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P150005|S009|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OPEN-IRRIGATED TEMPERATURE ABLATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/11/2016|||OK30|Sterilize the devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
P980003|S069|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||Cardiac ablation percutaneous catheter|CHILLI II|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/19/2016|||OK30|Addition of alternate vendors for manufacturing components for the Chilli II, Blazer OI, and IntellaNav OI Temperature Ablation Catheters.
P150005|S010|Boston Scientific Corp.|150 BAYTECH DRIVE||SAN JOSE|CA|95134||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|BLAZER OI; INTELLANAV OI|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/19/2016|||OK30|Addition of alternate vendors for manufacturing components for the Chilli II, Blazer OI, and IntellaNav OI Temperature Ablation Catheters.
P930014|S093|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF INTRAOCULAR LENSES|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/12/2016|||OK30|Reduction in Plan View Final Dimensional Inspection from 100% to sampling for all AcrySof Single-Piece, non-toric IOL models.
P150004|S004|Spinal Modulation, Inc|1135 O'BRIEN DR||MENLO PARK|CA|94025||Dorsal root ganglion stimulator for pain relief|AXIUM SHEATHS|PMP|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/18/2016|||OK30|Addition of an alternate supplier for a sub-assembly of the delivery sheaths used with the Axium Neurostimulator System.
P010033|S029|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack)|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/21/2016|08/19/2016|||OK30|Addition of two alternate suppliers for a raw material used to produce a critical assay component.
P960058|S119|ADVANCED BIONICS|28515 WESTINGHOUSE PLACE||VALENCIA|CA|91355||IMPLANT, COCHLEAR|HiResolution Bionic Ear System|MCM|EN|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/22/2016|11/29/2016|||APPR|Approval for the HiRes Ultra Implant Reusable Tools to be placed by AB into the market.
P850064|S033|BUNNELL, INC.|436 LAWNDALE DR.||SALT LAKE CITY|UT|84115||VENTILATOR, HIGH FREQUENCY|LIFE PULSE HIGH FREQUENCY VENTILATOR|LSZ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/18/2016|||OK30|Change to the Ultrasonic Welding Process used in fabrication of the Cartridge of the Patient Circuit.
P010015|S306|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/16/2016|||OK30|Update the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.
P010031|S558|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/16/2016|||OK30|Update the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.
P090013|S232|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Revo MRI SureScan IPG RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/16/2016|||OK30|Update the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.
P150033|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|Micra TPS MC1VR01|PNJ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/16/2016|||OK30|Update the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.
P980016|S597|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/16/2016|||OK30|Update the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.
P980035|S472|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/16/2016|||OK30|Update the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.
P150012|S012|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGEVITY ACTIVE FIXATION LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/11/2016|||OK30|Simplify the distal tip subassemblies for finished drug product testing.
P150033|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|MICRA TRANSCATHETER PACING SYSTEM|PNJ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/15/2016|||OK30|Implementation of a laboratory information management system in the microbiology lab.
P050037|S075|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 1.5cc|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|07/29/2016|||OK30|Modification of the nozzle used in the semi-automated filling process to fill RADIESSE product syringes.
P050052|S087|MERZ NORTH AMERICA, INC|4133 COURTNEY ROAD|SUITE 10|FRANKSVILLE|WI|53126||Implant, dermal, for aesthetic use|RADIESSE 0.8cc and 1.5cc|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|07/29/2016|||OK30|Modification of the nozzle used in the semi-automated filling process to fill RADIESSE product syringes.
P130028|S012|Nuvectra Corporation|10675 NAPLES STREET NE||BLAINE|MN|55449||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|ALGOVITA SPINAL CORD STIMULATION SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/22/2016|08/19/2016|||OK30|Changes to update the battery manufacturing equipment and addition of an alternate supplier for a wire battery component.
P970051|S149|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/24/2016|||OK30|Addition of an alternate PCB supplier for sound processor coils.
P130016|S020|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Cochlear implant with combined electrical stimulation and acoustic amplification|NUCLEUS 24 HYBRID  SYSTEM|PGQ|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/24/2016|||OK30|Addition of an alternate PCB supplier for sound processor coils.
P150003|S017|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/18/2016|||OK30|Update to the software used on the Automated Catheter Manufacturing Line Distal and Port Load and Unload stations in Galway.
P110010|S130|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/18/2016|||OK30|Update to the software used on the Automated Catheter Manufacturing Line Distal and Port Load and Unload stations in Galway.
P840001|S337|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/22/2016|||OK30|Changes to the manufacturing execution system (FACTORYworks) for Business Rule Client 9.2, Configuration Client 9.2, and Integrated Manufacturing Process Management Web Services 3.1.0.
P860004|S258|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/22/2016|||OK30|Changes to the manufacturing execution system (FACTORYworks) for Business Rule Client 9.2, Configuration Client 9.2, and Integrated Manufacturing Process Management Web Services 3.1.0.
P960009|S258|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/22/2016|||OK30|Changes to the manufacturing execution system (FACTORYworks) for Business Rule Client 9.2, Configuration Client 9.2, and Integrated Manufacturing Process Management Web Services 3.1.0.
P970004|S222|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (URINARY)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/22/2016|||OK30|Changes to the manufacturing execution system (FACTORYworks) for Business Rule Client 9.2, Configuration Client 9.2, and Integrated Manufacturing Process Management Web Services 3.1.0.
P080025|S117|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (BOWEL)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/22/2016|||OK30|Changes to the manufacturing execution system (FACTORYworks) for Business Rule Client 9.2, Configuration Client 9.2, and Integrated Manufacturing Process Management Web Services 3.1.0.
P910073|S139|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/22/2016|||OK30|Addition of a pull test process monitoring step.
P140004|S004|VERTIFLEX (R), INCORPORATED|1351 Calle Avanzado Suite 100||San Clemente|CA|92673||Prosthesis, spinous process spacer/plate|Superion® Interspinous Spacer|NQO|OR|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|07/25/2016|10/11/2016|||APPR|Approval for a design modification to the Superion® implants and new labeling.
P880086|S274|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|Assurity - PM1240, PM2240, Assurity+ - PM1260, PM2260, Endurity - PM1160, PM2160, Endurity Core - PM1152, PM2152|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/19/2016|||OK30|Alternate supplier of pacemaker case halves.
P030035|S148|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|Allure, Allure RF, Allure Quadra, Allure Quadra RF - PM3120, PM3222, PM3140, PM3242|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/19/2016|||OK30|Alternate supplier of pacemaker case halves.
P900033|S055|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||Dressing, wound and burn, interactive|INTEGRA ARTIFICIAL SKIN  & MESHED  DERMAL REGENERATION TEMPLATE,INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX, Integra Me|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/22/2016|||OK30|Implementation of upgraded equipment and software for pore size analysis.
P100047|S078|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/25/2016|08/18/2016|||OK30|Implementation of a manufacturing change for a component of the DC Power Adapter.
P110004|S019|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRxcell  CoCr Coronary Stent on RX System|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/23/2016|||OK30|Update to the stent rinsing step.
P110004|S020|MEDINOL LTD.|KIRYAT ATIDIM, BLDG. 7|ENTRANCE A, P.O.B. 58165|TEL-AVIV||61581||STENT, CORONARY|NIRxcell CoCr Cornary Stent on RX System|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/25/2016|||OK30|Update to the stent weighing process.
P130007|S018|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/24/2016|||OK30|Modify the cartridge leak test process for the Animas Vibe Insulin Pump, from a manual leak test to an automated leak test. The Animas Vibe Insulin Pump is a component of the Animas Vibe System.
P980049|S118|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|REPLY/ESPRIT PACEMAKER IMPLANTABLE DEVICES|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/26/2016|10/04/2016|||APPR|Approval for version 1.20 of the Orchestra & Orchestra Plus Programmer software used to interrogate and program the Reply/Esprit pacemakers.
P980022|S193|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|Paradigm Real-Time Revel Insulin Pump & Paradigm Real-Time Insulin Pump.|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/25/2016|||OK30|Add a new testing station to conduct a Manual Bolus Time Test (BTT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps.  These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.
P120010|S093|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MiniMed 530G Insulin Pump|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/25/2016|||OK30|Add a new testing station to conduct a Manual Bolus Time Test (BTT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps.  These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.
P150019|S018|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL INSULIN SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/25/2016|||OK30|Add a new testing station to conduct a Manual Bolus Time Test (BTT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps.  These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.
P930031|S056|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT ENDOPROSTHESIS (TIPS)|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/24/2016|||OK30|Outsourcing the compounding process for numerous resins.
P980033|S045|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDOPROSTHESIS (VENOUS)|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/24/2016|||OK30|Outsourcing the compounding process for numerous resins.
P940019|S047|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT ILIAC ENDOPROSTHESIS|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/24/2016|||OK30|Outsourcing the compounding process for numerous resins.
P930039|S154|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSUREFIX NOVUS LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/22/2016|||OK30|Additional laser welding equipment.
P140018|S003|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||Agent, occluding, vascular, permanent|VENASEAL CLOSURE SYSTEM|PJQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/26/2016|08/21/2016|||OK30|Implementation of a new drying oven used to remove moisture from the raw material.
P050006|S051|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE CARDIOFORM Septal Occluder|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2016|08/23/2016|||OK30|Add a new fixture for drying catheters following application of the HLC.
P970037|S009|PerkinElmer, Inc.|940 Winter Street||Waltham|MA|02451||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|AUTODELFIA HAFP TEST SYSTEM|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2016|08/23/2016|||OK30|Modification of two of the incoming quality control test methods performed for the bovine serum albumin (BSA) raw material and Change of the environmental ISO classification.
P120005|S052|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/27/2016|08/25/2016|||OK30|Addition of G4 PLATINUM Transmitter manufacturing space. The G4 PLATINUM Transmitter is a component of the G4 PLATINUM Continuous Glucose Monitoring System.
P850048|S042|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2016|08/26/2016|||OK30|Manufacturing process change to use PSA reference calibrators instead of commercial calibrators to establish a valid calibration curve during the in-process qualification of the coated PSA paramagnetic particles.
P120005|S053|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/28/2016|10/26/2016|||APPR|Approval for modifications to the Dexcom G5 Mobile Transmitter firmware.  The new transmitter firmware version comprises changes to the battery voltage limits, and correction of anomalies for a real time clock range error, firmware version display error, and an unrecoverable transmitter error at initialization.  The Dexcom G5 Mobile Transmitter is a component of the Dexcom G5® Mobile Continuous Glucose Monitoring System.
P110010|S131|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2016|08/19/2016|||OK30|Replace the current aluminum layer in the poly/foil laminate packaging with a different aluminum alloy.
P150003|S018|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2016|08/19/2016|||OK30|Replace the current aluminum layer in the poly/foil laminate packaging with a different aluminum alloy.
P010033|S030|QIAGEN|19300 Germantown Road||Germantown|MD|20874||TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS|QUANTIFERON-TB GOLD AND TB GOLD- Test (reference lab pack)|NCD|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2016|08/25/2016|||OK30|Changes to the sampling plan for the final release testing and removal of a testing specification.
P120006|S026|TRIVASCULAR INC|3910 BRICKWAY BLVD||SANTA ROSA|CA|95403||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/28/2016|08/24/2016|||OK30|Implementation of an update to the iliac stent graft sheath loading fixture configuration and a revision to the corresponding loading process instructions to include the updated fixture configuration; 2) Implementation of the modified maximum loading force specification and in-sheath force specification of the Ovation iX Iliac Limb Stent Graft; and3) Implementation of the modified crimp diameter for the 14 mm Ovation iX Iliac Stent Graft.
P130007|S019|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2016|11/05/2016|||APPR|Approval for modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of Dexcom’s G4 PLATINUM/G5 Mobile sensor component, which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method.  The sensor is a component of the Animas Vibe System.
P910018|S021|KANEKA PHARMA AMERICA CORP.|546 FIFTH AVE., 21ST FLOOR||NEW YORK|NY|10036||LIPOPROTEIN, LOW DENSITY, REMOVAL|LIPOSORBER(R) LA-15 SYSTEM|MMY|GU|Normal 180 Day Track|Labeling Change - Indications/instructions/shelf life/tradename|N|07/29/2016|10/14/2016|||APPR|Approval for modifications to the instructions for use, operator's manual, and the patient guide for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and integration of instructions for use for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and focal segmental glomerulosclerosis.
P150023|S002|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||Absorbable coronary drug-eluting stent|ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM|PNY|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|07/29/2016|08/25/2016|||APPR|Approval for labeling changes to clarify the interpretation of the ABSORB III clinical data for geriatric patients in the Absorb GT1 BVS Instructions for Use.
P020014|S047|BAYER PHARMA AG|MOLLERSTRABE 178||BERLIN||13353||Transcervical contraceptive tubal occlusion device|Essure System for Permanent Birth Control (Model ESS305)|HHS|OB|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|07/29/2016|09/29/2016|||APPR|Approval of changes to the post-approval protocol.
P140010|S023|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER|ONU|CV|Normal 180 Day Track No User Fee|Labeling Change - PAS|N|07/29/2016|10/20/2016|||APPR|Approval for labeling updates to include 24 month data.
P150024|S001|ASPIRE BARIATRICS INC|3200 HORIZON DRIVE|SUITE 100|King of Prussia|PA|19406||Aspiration therapy system|AspireAssist|OYF|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2016|09/01/2016|||APPR|Approval of the addition of a lot number to the Skin Port and Connector.
P150012|S013|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Essentio, Proponent and Accolade MRI Pacemakers|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|07/29/2016|10/04/2016|||APPR|Approval for an alternate capacitor in the medical implant communication service module component.
P840001|S338|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATIONS LE|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2016|08/25/2016|||OK30|Addition of a new supplier of polysulfone resin.
P960009|S259|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|07/29/2016|08/25/2016|||OK30|Addition of a new supplier of polysulfone resin.
P980023|S077|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|Protego SD 60/16, Protego SD 65/16, Protego SD 65/18, Protego SD 75/18, Protego TD 65/16, Protego TD 65/18, Protego TD 7|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/22/2016|||OK30|Addition of an alternate supplier for the DF4 connector.
P130030|S027|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/29/2016|||OK30|Transfer a stent polishing line from the Boston Scientific Corporation (BSC) Plymouth facility to the BSC Maple Grove facility.
P110010|S132|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS PREMIER  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/29/2016|||OK30|Transfer a stent polishing line from the Boston Scientific Corporation (BSC) Plymouth facility to the BSC Maple Grove facility.
P100045|S010|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF SYSTEM|MOM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/30/2016|||OK30|Implementation of an automated system for environmental monitoring in production areas.
P110007|S008|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL  DEVICE (OVD) (3% Sodium Hyaluronate)|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/01/2016|10/07/2016|||APPR|Approval for modification of the finger grips on the Ophthalmic Viscoelastic Device (OVD) delivery device.
P150003|S019|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/29/2016|||OK30|Transfer a stent polishing line from the Boston Scientific Corporation (BSC) Plymouth facility to the BSC Maple Grove facility.
P810031|S058|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||AID, SURGICAL, VISCOELASTIC|Healon Ultimate Dual Pack, HEALON, HEALON GV, HEALON5, and Healon Duet Dual Pack products|LZP|OP|Real-Time Process|Change Design/Components/Specifications/Material|N|08/01/2016|10/07/2016|||APPR|Approval for modification of the finger grips on the Ophthalmic Viscoelastic Device (OVD) delivery device.
P150017|S001|Cartiva, Inc|6120 Windward Parkway|Suite 220|Alpharetta|GA|30005||Prosthesis, metatarsophalangeal joint cartilage replacement implant|CARTIVA SYNTHETIC CARTILAGE IMPLANT|PNW|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/25/2016|||OK30|Change the vendor that supplies the foil lidstock used to seal the primary packaging of the Cartiva SCI device.
P950027|S015|FIDIA FARMACEUTICI SPA|VIA PONTE DELLA FABBRICA 3/A||ABANO TERME, PADUA (PD)||35031||Acid, hyaluronic, intraarticular|HYALGAN|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/26/2016|||OK30|Change in the filter cartridge used during manufacturing of Hyalgan.
P840001|S339|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel Spinal Cord Stimulation Systems|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/31/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P860004|S259|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SYNCHROMED INFUSION SYSTEM|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/31/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P960009|S260|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|Activa Deep Brain Stimulation Therapy System|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/31/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P970004|S223|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/31/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P080025|S118|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM Therapy System for Bowel Control|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/31/2016|||OK30|Alternate printed wiring board for use in hybrid manufacturing.
P150017|S002|Cartiva, Inc|6120 Windward Parkway|Suite 220|Alpharetta|GA|30005||Prosthesis, metatarsophalangeal joint cartilage replacement implant|CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE|PNW|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/01/2016|09/29/2016|||APPR|Approval of the protocol for the ODE Lead PMA Post-Approval Study protocol.
P060011|S010|RAYNER INTRAOCULAR LENSES LTD.|1-2 SACKVILLE TRADING ESTATE,|SACKVILLE ROAD|HOVE, EAST SUSSEX||BN3 7||intraocular lens|C-FLEX MODEL 570C, C-Flex Aspheric 970C and 600 C Aspheric INTRAOCULAR LENS (IOL)|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/01/2016|08/19/2016|||OK30|Change the final stage of the tumble polish process for C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses.
P800036|S039|CODMAN & SHURTLEFF, INC.|325 PARAMOUNT DR.||RAYNHAM|MA|02767|0350|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|Model 400 Implantable Infusion Pump|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2016|08/29/2016|||OK30|Approval for modifications associated with accessories for P800036 and P890055: Needles: needle drawing changes and process control improvements at the supplier; and Luer adaptor: supplier manufacturing site changes.
P890055|S064|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|Codman 3000 Series Constant-Flow Implantable Infusion Pump and MedStream Implantable Infusion Pump|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2016|08/29/2016|||OK30|Approval for modifications associated with accessories for P800036 and P890055: Needles: needle drawing changes and process control improvements at the supplier; and Luer adaptor: supplier manufacturing site changes.
P090013|S233|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CapSureFix MRI Lead|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2016|09/01/2016|||OK30|Update to power and weld settings in the laser welding process.
P930039|S155|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSureFix Novus Lead|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/02/2016|09/01/2016|||OK30|Update to power and weld settings in the laser welding process.
P140015|S013|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Pump, infusion, insulin, to be used with invasive glucose sensor|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2016|09/01/2016|||OK30|Alternative endotoxin test for the t:slim G4 Insulin Pump  and to conduct the test in-house at Tandem Diabetes Care, Inc. The t:slim G4 Insulin Pump is a component of the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM System.
P000021|S029|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE|PO BOX 6101|NEWARK|DE|19714|6101|PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|DIMENSION TPSA FLEX REAGENT CARTRIDGE (RF451)|LTJ|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2016|08/30/2016|||OK30|Add a filtration step in the Chrome Particle Raw Material (CPRM) manufacturing process.
P930014|S095|Alcon Research, Ltd.|6201 SOUTH FREEWAY DR.||FORT WORTH|TX|76134||intraocular lens|ACRYSOF Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2016|08/11/2016|||OK30|Change in aeration time after EO sterilization for PMMA IOLs and for AcrySof® Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System at the Huntington AODC manufacturing facility.
P880087|S025|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|Single-Piece Anterior Chamber IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2016|08/11/2016|||OK30|Change in aeration time after EO sterilization for PMMA IOLs and for AcrySof® Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System at the Huntington AODC manufacturing facility.
P810032|S066|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|Multi-Piece Posterior Chamber IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2016|08/11/2016|||OK30|Change in aeration time after EO sterilization for PMMA IOLs and for AcrySof® Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System at the Huntington AODC manufacturing facility.
P840060|S043|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||intraocular lens|Single-Piece Posterior Chamber IOL|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2016|08/11/2016|||OK30|Change in aeration time after EO sterilization for PMMA IOLs and for AcrySof® Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System at the Huntington AODC manufacturing facility.
P020027|S024|SIEMENS HEALTHCARE DIAGNOSTICS|500 GBC DRIVE, P O BOX 6101|M/S 514|NEWARK|DE|19714|6101|TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS|DIMENSION FPSA FLEX REAGENT CARTRIDGE (RF452)|MTG|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2016|08/30/2016|||OK30|Add a filtration step in the Chrome Particle Raw Material (CPRM) manufacturing process.
P930029|S055|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|RF ENHANCR II|LPB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/03/2016|09/29/2016|||APPR|Approval for molding and pad printing changes to the RF Enhancr II handle.
P150038|S001|InSightec|5 NAHUM HETH STREET||TIRAT-HACARMET||39120||MR-Guided Focused Ultrasound System|EXABLATE NEURO THALAMOTOMY|POH|NE|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/03/2016|09/29/2016|||APPR|Approval of the protocol for the ODE Lead PMA Post-Approval Study protocol.
P100047|S079|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/03/2016|09/01/2016|||OK30|Implementation of an alternate automated option for the Taylor Hobson Profilometer.
P140028|S016|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2016|09/02/2016|||OK30|Modifications to an in-process control.
P010014|S055|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/05/2016|09/01/2016|||APPR|Approval for the addition of a radiographic assessment decision aid to supplement the patient selection criteria provided in the approved surgical technique for the Oxford Partial Knee System.
P080012|S035|FLOWONIX MEDICAL, INC.|500 INTERNATIONAL DRIVE|SUITE 200|MT.OLIVE|NJ|07828||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|PROMETRA PROGRAMMABLE IMPLANTABLE PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/05/2016|08/31/2016|||OK30|Inspection fixtures, inspection set-up, and manufacturing fixture changes used for verifying and assembling the Prometra and Prometra II pumps.
P060037|S046|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2016|09/01/2016|||OK30|Addition of Ambatovy Cobalt and Novotroisk Chromium, as second-tier approved raw material suppliers of Zimaloy Cobalt-Chromium-Molybdenum-Alloy Continuous Cast Ignot, used in the manufacture of the femoral components of the NexGen LPS-Flex/LPS Mobile Bearing Knee System.
P060006|S078|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, RENAL|EXPRESS SD RENAL PREMOUNTED STENT SYSTEM|NIN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2016|08/30/2016|||OK30|Supplier site change.
P130030|S028|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2016|08/30/2016|||OK30|Supplier site change.
P140031|S019|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2016|09/06/2016|||OK30|Removal of an in-process inspection for stent frames.
P150014|S004|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS HBV TEST|MKT|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2016|10/31/2016|||APPR|Approval for cobas 6800/8800 Systems Software version 1.01.10 to address risks related with sample under-aspiration.
P110035|S037|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/08/2016|08/30/2016|||OK30|Supplier site change.
P150015|S004|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS HCV TEST|MZP|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|08/08/2016|10/31/2016|||APPR|Approval for cobas 6800/8800 Systems Software version 1.01.10 to address risks related with sample under-aspiration.
P150014|S005|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS HBV TEST|MKT|MI|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/08/2016|10/31/2016|||APPR|Approval for the addition of a 200µL sample input volume claim.
P980049|S119|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|Platinum VR and DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD's|MRM|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/09/2016|09/07/2016|||APPR|Approval for Platinium embedded software version 2.4.2.
P060027|S084|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Platinum CARDIAC RESYNCHRONIZATION THERAPY DEFBRILLATOR CRT's|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/09/2016|09/07/2016|||APPR|Approval for Platinium embedded software version 2.4.2.
P140015|S014|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Pump, infusion, insulin, to be used with invasive glucose sensor|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2016|09/08/2016|||OK30|Implementation of process improvements to the manufacturing and testing of the cartridge for the t:slim G4 Insulin Pump. The t:slim G4 Insulin Pump is a component of the T:Slim G4 Insulin Pump with Dexcom G4 Platinum CGM.
P070026|S042|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC TOTAL HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2016|09/07/2016|||OK30|Change in dosimetry system from PMMA to Alanine at the subcontractor Synergy Westport sterilization site.
P830055|S174|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2016|09/07/2016|||OK30|Change in dosimetry system from PMMA to Alanine at the subcontractor Synergy Westport sterilization site.
P120022|S013|QIAGEN MANCHESTER LTD|SKELTON HOUSE|LLOYD STREET NORTH|MANCHESTER||M15 6||Somatic gene mutation detection system|THERASCREEN EGFR RGQ PCR KIT|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2016|09/07/2016|||OK30|Change to the mean Ct specification for the positive control (PC) at the final kit release stage and the target Ct value for the manufacturing adjustment process for the L861Q reaction mix.
P140031|S020|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS CRIMPER|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/10/2016|08/23/2016|||OK30|Addition of the Draper, UT facility as an alternate manufacturing site for the Edwards Crimper.
P010030|S080|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LIFEVEST WEARABLE DEFIBRILLATOR (WCD) 3000, 4000|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2016|09/01/2016|||OK30|Automated inspection test for therapy electrode assemblies.
P150011|S005|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|PERCEVAL SUTURELESS HEART VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2016|09/23/2016|||APPR|Approval for the addition of a new bovine tissue supplier.
P130011|S005|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|SOLO SMART STENTLESS HEART VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2016|09/23/2016|||APPR|Approval for the addition of a new bovine tissue supplier.
P060038|S029|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2016|09/23/2016|||APPR|Approval for the addition of a new bovine tissue supplier.
P100047|S080|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2016|09/07/2016|||OK30|Additional coating chamber at the existing coating supplier for processing components of the HVAD.
P130021|S024|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|COREVALVE (TM) EVOLUTE (TM) R SYSTEM|NPT|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/11/2016|08/22/2016|||APPR|Approval for modifications to the CoreValve Evolut R System Instructions for Use.
P970003|S204|Cyberonics, Inc.|100 CYBERONICS BLVD.||HOUSTON|TX|77058|2017|STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY|ASPIRESR MODEL 106 GENERATOR|LYJ|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2016|09/09/2016|||OK30|Implementation of new electrical testing for the Model 106 Generator used in the VNS Therapy System, with additional minor test software corrections and improvements.
P010012|S430|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ACUITY X4 Drug Collar Component Dwell Time|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/11/2016|09/01/2016|||OK30|Extension to the drug collar dwell time.
P010019|S052|Alcon Laboratories, Inc.|6201 South Freeway||Fort Worth|TX|76134|2099|Lenses, soft contact, extended wear|LOTRAFILCON A AND B SOFT CONTACT LENSES FOR DAILY AND EXTENDED WEAR|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/08/2016|||OK30|Adding an alternate foil lidding material.
P840001|S340|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/09/2016|||OK30|Relocation of titanium cleaning and annealing processes from Bodycote to Greatbatch Medical.
P860004|S260|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|SynchroMed Infusion System|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/09/2016|||OK30|Relocation of titanium cleaning and annealing processes from Bodycote to Greatbatch Medical.
P960009|S261|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|Activa Deep Brain Stimulation Therapy System|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/09/2016|||OK30|Relocation of titanium cleaning and annealing processes from Bodycote to Greatbatch Medical.
P860057|S152|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per|DYE|CV|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/12/2016|10/20/2016|||APPR|Approval for labeling changes related to MR compatibility and minor clarifications to the implant procedure.
P970004|S224|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|InterStim Therapy System|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/09/2016|||OK30|Relocation of titanium cleaning and annealing processes from Bodycote to Greatbatch Medical.
P080025|S119|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|InterStim Therapy System|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/09/2016|||OK30|Relocation of titanium cleaning and annealing processes from Bodycote to Greatbatch Medical.
P140031|S021|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE (THV), MODEL 9600TFX|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/08/2016|||OK30|Reduce the sampling plan for the dimensional inspection and remove an inspection step in the manufacturing process of the cloth skirts used in the SAPIEN 3 THV.
P960016|S067|St. Jude Medical|14900 MINNETONKA IND RD||MINNETONKA|MN|55345||Cardiac ablation percutaneous catheter|Livewire TC Steerable Electrophysiology Catheter|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/08/2016|||OK30|Changes to the environmental specifications and installation of data loggers for environmental monitoring.
P040014|S031|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||Cardiac ablation percutaneous catheter|Therapy Ablation Catheters|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/08/2016|||OK30|Changes to the environmental specifications and installation of data loggers for environmental monitoring.
P060019|S038|IRVINE BIOMEDICAL, INC.|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|Therapy Cool Path Ablation Catheters|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/08/2016|||OK30|Changes to the environmental specifications and installation of data loggers for environmental monitoring.
P970029|S032|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION|CARDIOGENESIS TMR LASER SYSTEM|MNO|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/12/2016|08/23/2016|||APPR|Approval for labeling changes to enhance the safety of CardioGenesis® TMR Laser System.
P110016|S035|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|Therapy Cool Path Duo/Safire Blu Duo Ablation Catheters|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/08/2016|||OK30|Changes to the environmental specifications and installation of data loggers for environmental monitoring.
P040042|S036|IRVINE BIOMEDICAL,INC.(IBI)|2375 MORSE AVE.||IRVINE|CA|92614||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|Therapy Dual 8 Ablation Catheters|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/08/2016|||OK30|Changes to the environmental specifications and installation of data loggers for environmental monitoring.
P130026|S022|St. Jude Medical|One St. Jude Medical Drive||St. Paul|MN|55117||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|TactiCath Quartz Catheter and TactiSys Quartz Equipment|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/12/2016|09/08/2016|||OK30|Changes to the environmental specifications and installation of data loggers for environmental monitoring.
P130024|S015|LUTONIX|9409 SCIENCE CENTER DR||NEW HOPE|MN|55428||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|LUTONIX DRUG COATED BALLOON PTA CATETER|ONU|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|08/15/2016|10/14/2016|||APPR|Approval of changes to the post-approval study for the device.
P840001|S341|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimulation Lead|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/13/2016|||OK30|Addition of an alternate supplier of lead wire components and implementation of an alternate test equipment for that supplier.
P970004|S225|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (FOR URINARY CONTROL)|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/2016|11/10/2016|||APPR|Approval for updates to patient and physician labeling for Medtronic Sacral Neuromodulation (SNM) Therapy.
P960009|S262|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|Activa Deep Brain Stimulation Therapy System|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/13/2016|||OK30|Addition of an alternate supplier of lead wire components and implementation of an alternate test equipment for that supplier.
P970004|S226|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|InterStim Therapy System|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/13/2016|||OK30|Addition of an alternate supplier of lead wire components and implementation of an alternate test equipment for that supplier.
P080025|S120|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (FOR BOWEL CONTROL)|EZW|GU|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|08/15/2016|11/10/2016|||APPR|Approval for updates to patient and physician labeling for Medtronic Sacral Neuromodulation (SNM) Therapy.
P080025|S121|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|InterSlim Therapy System|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/13/2016|||OK30|Addition of an alternate supplier of lead wire components and implementation of an alternate test equipment for that supplier.
P100047|S081|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/12/2016|||OK30|Implementation of an alternate supplier for the polyester yarn used in the manufacturing of the HVAD Sewing Ring.
P100042|S011|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV ASSAY|OYB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/13/2016|||OK30|Addition of a new site for the manufacturing of oligonucleotides.
P120007|S009|GEN-PROBE INCORPORATED|10210 Genetic Center Drive||San Diego|CA|92121||Kit, rna detection, human papillomavirus|APTIMA HPV 16 18/45 GENOTYPE ASSAY|OYB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/13/2016|||OK30|Addition of a new site for the manufacturing of oligonucleotides.
P840001|S342|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/14/2016|||OK30|Use of Cell Operating System workstation U-shaped configuration instead of the current use of a clean bench in the Neuromodulation Sterile Packaging manufacturing area at Medtronic Puerto Rico Operation Company (MPROC).
P960009|S263|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|Activa Deep Brain Stimulation Therapy System|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/14/2016|||OK30|Use of Cell Operating System workstation U-shaped configuration instead of the current use of a clean bench in the Neuromodulation Sterile Packaging manufacturing area at Medtronic Puerto Rico Operation Company (MPROC).
P970004|S227|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/14/2016|||OK30|Use of Cell Operating System workstation U-shaped configuration instead of the current use of a clean bench in the Neuromodulation Sterile Packaging manufacturing area at Medtronic Puerto Rico Operation Company (MPROC).
P080025|S122|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/14/2016|||OK30|Use of Cell Operating System workstation U-shaped configuration instead of the current use of a clean bench in the Neuromodulation Sterile Packaging manufacturing area at Medtronic Puerto Rico Operation Company (MPROC).
P150017|S003|Cartiva, Inc|6120 Windward Parkway|Suite 220|Alpharetta|GA|30005||Prosthesis, metatarsophalangeal joint cartilage replacement implant|CARTIVA SYNTHETIC CARTILAGE IMPLANT|PNW|OR|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|11/01/2016|||APPR|Approval for the addition of 8 and 20-unit shipping configurations to accommodate smaller orders.
P150024|S003|ASPIRE BARIATRICS INC|3200 HORIZON DRIVE|SUITE 100|King of Prussia|PA|19406||Aspiration therapy system|AspireAssist|OYF|GU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/15/2016|09/13/2016|||APPR|Approval for the addition of a Skin-Port manufacturing in-process leak test.
P150022|S002|REX MEDICAL, L.P.|555 E. NORTH LANE SUITE 5035||CONSHOHOCKEN|PA|19428||Device, hemostasis, vascular|CLOSER VASCULAR SEALING SYSTEM|MGB|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/15/2016|11/10/2016|||APPR|Approval to implement minor design modifications to the production sheath cap.
P980044|S034|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX, VISCO-3|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2016|09/13/2016|||OK30|Change in the VISCO-3 packaging process from manual to a modified automated packaging process.
P940035|S013|ALERE SCARBOROUGH, INC|10 Southgate Road||Scarborough|ME|04074||System,test,tumor marker,for detection of bladder cancer|Alere NMP22 BladderChek Test|NAH|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2016|09/08/2016|||OK30|Additional vendor for the goat anti-mouse lgG antibody used in the manufacture of the Alere NMP22® BladderChek® Test procedural control line.
P060038|S030|LivaNova Canada Corp.|5005 North Fraser Way||Burnaby||V5J 5||heart-valve, non-allograft tissue|MITROFLOW AORTIC PERICARDIAL HEART VALVE|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2016|09/14/2016|||OK30|Upgrade to the Covered Stent Controlled Environment (CSCE) from a lower ISO cleanroom classification to a higher classification as well as the extension of covered stent manufacturing activities to two additional controlled environments.
P150024|S004|ASPIRE BARIATRICS INC|3200 HORIZON DRIVE|SUITE 100|King of Prussia|PA|19406||Aspiration therapy system|AspireAssist|OYF|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/16/2016|11/04/2016|||APPR|Approval for a design modification to extend the length of the drain tube.
P060030|S054|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AMPLIPREP/COBAS TAQMAN HCV TEST|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/16/2016|09/13/2016|||OK30|Production scale-up of bulk reagents for the COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.
P140028|S017|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2016|09/12/2016|||OK30|Changes to stent machining parameters.
P960040|S379|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|NG3 Implantable Cardioverter Defibrillator (ICD), ORIGEN, INOGEN, DYNAGEN EL ICD'S; NG2 Implantable Cardioverter Defibri|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2016|09/13/2016|||OK30|Changes to visual inspection criteria for cosmetic defects.
P010012|S431|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT); DYNAGEN. INOGEN, ORIGEN CRT-D & X4 CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2016|09/13/2016|||OK30|Changes to visual inspection criteria for cosmetic defects.
N970003|S193|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Ingenio 2 Pacemakers, ALTURA 2, ESSENTIO, PROPONENT, ACCOLADE MODEL'S|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2016|09/13/2016|||OK30|Changes to visual inspection criteria for cosmetic defects.
P030005|S141|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|Cardiac Resynchronization Therapy- Pacemaker (CRT-P); INVIVE & INTUA MODELS; Ingenio 2 CRT-P Devices VALITUDE MODEL U 12|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2016|09/13/2016|||OK30|Changes to visual inspection criteria for cosmetic defects.
P150012|S014|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Ingenio 2 Pacemakers, ESSENTIO, PROPONENT, ACCOLADE MRI MODELS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2016|09/13/2016|||OK30|Changes to visual inspection criteria for cosmetic defects.
P110042|S062|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM S-ICD SYSTEM & EMBLEM MRI S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2016|09/13/2016|||OK30|Changes to visual inspection criteria for cosmetic defects.
P980035|S473|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/17/2016|09/01/2016|||OK30|New annealing vacuum oven used during the manufacture of the battery cases.
P130007|S020|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2016|09/15/2016|||OK30|Addition of a second Main Board assembly line for the Animas Vibe Insulin Pump at the supplier.  The Vibe Insulin Pump is a component of the Animas Vibe System.
P030017|S256|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION, PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/18/2016|09/16/2016|||OK30|Implement an additional rework process for the Clik Anchor subassembly used in the Precision, Precision Spectra, and Precision Novi Spinal Cord Stimulation Systems.
P110043|S011|ABBOTT VASCULAR-CARDIAC THERAPIES|3200 LAKESIDE DR.||SANTA CLARA|CA|95054|2807|STENT, ILIAC|OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/14/2016|||OK30|Move part of the manufacturing process from one room to another.
P980044|S035|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|SUPARTZ FX VISCO-3|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/14/2016|||OK30|Addition of a batch size for the manufacture of SUPARTZ FX and VISCO-3.
P140028|S018|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/16/2016|||OK30|Updated equipment for the stent component manufacturing.
P900033|S056|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||Dressing, wound and burn, interactive|INTEGRA ARTIFICAL SKIN DERMAL REGENERATION TEMPLATE|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/15/2016|||OK30|Replacement of a portion of the water deionization (DI) system, located in the Collagen Manufacturing Center. Integra will replace a portion of the DI system with a new Evoqua IonRight GEN3 system.  The change is being made to lower operating expenses, as well as reduce the frequency of service of the system by reducing the frequency at which the vessels are shipped off site for regeneration.
P990009|S043|BAXTER HEALTHCARE CORP.|32650 N WILSON RD||ROUND LAKE|IL|60073||Absorbable collagen hemostatic agent with thrombin|FLOSEAL HEMOSTATIC MATRIX|PMX|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/19/2016|09/14/2016|||APPR|Approval for labeling changes to enhance the safety of your device, including removal of the phrase spurting from bleeding types for which use of the device is described as effective in the warnings section of the labeling.
P840062|S057|COLLA-TEC, INC.|P.O. BOX 688||PLAINSBORO|NJ|08536||MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID|COLLACOTE(TM) COLLATAPE(R) ABSORBABLE COLLEGAGEN WOUND DRESSINGS|LPG|DE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/15/2016|||OK30|Replacement of a portion of the water deionization (DI) system, located in the Collagen Manufacturing Center. Integra will replace a portion of the DI system with a new Evoqua IonRight GEN3 system.  The change is being made to lower operating expenses, as well as reduce the frequency of service of the system by reducing the frequency at which the vessels are shipped off site for regeneration.
P850010|S072|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08540||Agent, absorbable hemostatic, collagen based|HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/15/2016|||OK30|Replacement of a portion of the water deionization (DI) system, located in the Collagen Manufacturing Center. Integra will replace a portion of the DI system with a new Evoqua IonRight GEN3 system.  The change is being made to lower operating expenses, as well as reduce the frequency of service of the system by reducing the frequency at which the vessels are shipped off site for regeneration.
P810006|S073|INTEGRA LIFESCIENCES CORPORATION|311 ENTERPRISE DR.||PLAINSBORO|NJ|08536||Agent, absorbable hemostatic, collagen based|COLLASTAT / INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS|LMF|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/15/2016|||OK30|Replacement of a portion of the water deionization system located in the Collagen Manufacturing Center at 105 Morgan Lane, Plainsboro, New Jersey, 08536.
P010031|S559|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI & Quad CRT-D's; Brava  CRT-D & Quad CRT-D's; Compia MRI CRT-D & Quad CRT-D; Viva Quad S & XT CRT-D; Viva S CR|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/15/2016|||OK30|Elimination of an in-process pull test performed on the connector subassembly.
P980016|S598|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AM MRI VR ICD and Visia AF VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/19/2016|09/15/2016|||OK30|Elimination of an in-process pull test performed on the connector subassembly.
P150013|S003|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC 22C3 PHARMDX|PLS|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2016|12/01/2016|||APPR|Approval for the DakoLink software version 4.1 update for the PD-L1 IHC 22C3 pharmDx.
P150025|S002|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC 28-8 PHARMDX (Non-Squamous Indication)|PLS|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2016|12/01/2016|||APPR|Approval for the DakoLink software version 4.1 update for the PD-L1 IHC 28-8 pharmDx (non-squamous, non-small cell lung cancer indication).
P150027|S002|DAKO NORTH AMERICA, INC.|6392 VIA REAL||CARPINTERIA|CA|93013||Immunohistochemistry assay, antibody, programmed death-ligand 1|PD-L1 IHC 28-8 PHARMDX (Melanoma Indication)|PLS|PA|Real-Time Process|Change Design/Components/Specifications/Material|N|08/19/2016|12/01/2016|||APPR|Approval for the DakoLink software version 4.1 update for the PD-L1 IHC 28-8 pharmDx (melanoma indication).
P860057|S153|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||replacement Heart-valve|EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/19/2016|||OK30|Implement an additional in-process flow tester at the Singapore facility.
P110020|S018|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS 4800 BRAF V600 MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/20/2016|||OK30|Manufacturing scale increase for bulk manufacturing of components.
P130009|S064|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/19/2016|||OK30|Implement an additional in-process flow tester at the Singapore facility.
P120019|S011|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/20/2016|||OK30|Manufacturing scale increase for bulk manufacturing of components.
P140031|S022|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/19/2016|||OK30|Implement an additional in-process flow tester at the Singapore facility.
P150047|S001|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS EGFR MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/20/2016|||OK30|Manufacturing scale increase for bulk manufacturing of components.
P140023|S007|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS KRAS MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/20/2016|||OK30|Manufacturing scale increase for bulk manufacturing of components.
P030011|S045|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM|LOZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/21/2016|||OK30|Addition of an alternate supplier for the AC Power Cord.
P830055|S175|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/20/2016|||OK30|Addition of a two dimensional (2D) barcode to the PFC Sigma RPF Tibial inserts and changes to the inspection process for the LCS® Total Knee System.
P010003|S025|CRYOLIFE, INC.|1655 ROBERTS BLVD., N.W.||KENNESAW|GA|30144||Glue,surgical,arteries|BIOGLUE SURGICAL ADHESIVE|MUQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/08/2016|||OK30|Reuse of the BioGlue insulated outer shipper for irradiation.
P100047|S083|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/20/2016|||OK30|Implementation of the Rofin Laser Welding station for the welding of the HVAD Impeller Assembly.
P980040|S073|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1-Piece IOL; OptiBlue; Multifocal; Toric 1-Piece IOLs; TECNIS i Tee Preloaded Delivery System; Symfont Extended R|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|09/16/2016|||OK30|Modifications to the cryotumbling process for your TECNIS 1-piece lenses.
P980049|S120|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|Paradym VR, DR,Paradym RF VR, Paradym RF DR (ZL101),(ZL102),Intensia VR, Intensia DR,Platinium VR 1210, Platinium VR 124|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2016|09/20/2016|||OK30|Alternate method for the laser welding process.
P060027|S085|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Paradym CRT-D; Paradym RF CRT-D (ZL101),(ZL102); Intensia CRT-D; Platinium CRT-D 1711,1741.|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2016|09/20/2016|||OK30|Alternate method for the laser welding process.
P980049|S121|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|Platinium VR 1210,1240 (ICD); Platinium DR 1510, 1540 (ICD)|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2016|09/07/2016|||OK30|Change to the execution sequence for the final functional electrical test and the final functional test for radio frequency.
P060027|S086|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Platinium CRT-D 1711, 1741.|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2016|09/07/2016|||OK30|Change to the execution sequence for the final functional electrical test and the final functional test for radio frequency.
P980049|S122|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER|ICDs (Implantable Cardioverter Defibrillator) Platinium VR 1210, 1240; Platinium DR 1510, 1540.|MRM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2016|09/21/2016|||OK30|Alternate manufacturing flow sequence, the addition of new dispensing equipment and an optional step in the manufacturing line for the microelectronic and electronic assembly.
P060027|S087|SORIN GROUP CRM USA, INC|4, AVENUE REAUMUR||CLAMART CEDEX||92140||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CRT-Ds (Cardiac Resynchronization Therapy Defibrillator),Platinium CRT-D 1711, 01741|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2016|09/21/2016|||OK30|Alternate manufacturing flow sequence, the addition of new dispensing equipment and an optional step in the manufacturing line for the microelectronic and electronic assembly.
P130012|S001|Greatbatch Medical|2300 BERKSHIRE LANE NORTH||MINNEAPOLIS|MN|55441||permanent pacemaker Electrode|MYOPORE SUTURELESS MYOCARDIAL PACING LEAD|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2016|09/19/2016|||OK30|Implementation of a new silicone mill.
P140015|S015|Tandem Diabetes Care, Inc.|11045 Roselle Street||San Diego|CA|92121||Pump, infusion, insulin, to be used with invasive glucose sensor|T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM|OYC|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/23/2016|09/23/2016|||OK30|Change testing software for the t:slim G4 Insulin Pump and to remove one upper limit acceptance criterion for the software test at the Tandem Diabetes Care manufacturing plant in San Diego, CA. The t:slim G4 Insulin Pump is a component of the Dexcom G4 Platinum CGM System.
P900033|S057|Integra LifeSciences Corp.|105 MORGAN LN.||PLAINSBORO|NJ|08536||Dressing, wound and burn, interactive|INTEGRA Artificial Skin Dermal Regeneration Template|MGR|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2016|09/22/2016|||OK30|New Tyvek heat sealer and sealing parameters.
P150037|S001|Alcon Research, Ltd|6201 South Freeway||Fort Worth|TX|76134||Intraocular pressure lowering implant|COMPASS-XT|OGO|OP|Normal 180 Day Track No User Fee|Postapproval Study Protocol - ODE/OIR|N|08/24/2016|11/03/2016|||APPR|Approval of the protocol for the post-approval study (PAS).
P030031|S076|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL & UNI-DIRECTIONAL NAVIGATION CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2016|09/20/2016|||OK30|Adding a second source supplier for the tip shell and sensor support component used in the THERMOCOOL SMARTTOUCH SF Navigation Catheters.
P090031|S007|Anika Therapeutics, Inc.|32 WIGGINS AVENUE||BEDFORD|MA|01730||Acid, hyaluronic, intraarticular|MONOVISC|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/24/2016|10/04/2016|||OK30|Change from a manual manufacturing process to an automated process for the assembly of the syringe plunger rod and flange extender.
P120017|S005|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|Myocardial Pacing Lead|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2016|09/20/2016|||OK30|Updates to pull test sample sizes and control limits.
P080006|S097|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|Attain Ability Lead, Attain Performa Lead|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2016|09/20/2016|||OK30|Updates to pull test sample sizes and control limits.
P830061|S132|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSure Sense Lead; Vitatron Crystalline Lead, ICM09|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2016|09/20/2016|||OK30|Updates to pull test sample sizes and control limits.
P920015|S182|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|Sprint Quattro Lead; Subcutaneous Lead|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2016|09/20/2016|||OK30|Updates to pull test sample sizes and control limits.
P040027|S049|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2016|09/21/2016|||OK30|Implementation of changes to zipper manufacturing which include the use of modified braider machines and a new oven rack and spatula to increase manufacturing capacity.
P930039|S156|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSure Fix Novus Lead; Vitatron Crystalline Active; Fixation Lead, ICF09, ICQ09B|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2016|09/20/2016|||OK30|Updates to pull test sample sizes and control limits.
P040037|S093|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2016|09/21/2016|||OK30|Implementation of changes to zipper manufacturing which include the use of modified braider machines and a new oven rack and spatula to increase manufacturing capacity.
P130006|S032|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/25/2016|09/21/2016|||OK30|Implementation of changes to zipper manufacturing which include the use of modified braider machines and a new oven rack and spatula to increase manufacturing capacity.
P970004|S228|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (FOR URINARY CONTROL)|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2016|11/23/2016|||APPR|Approval for changes to two firmware requirements for Medtronics Model 3531 Verify External Neurostimulator.
P080025|S123|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (FOR BOWEL CONTROL)|EZW|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|08/25/2016|11/23/2016|||APPR|Approval for changes to two firmware requirements for Medtronic’s Model 3531 Verify External Neurostimulator.
N970003|S143|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE|LWP|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/25/2012|05/23/2013|||APPR|
P950005|S062|CORDIS CORP.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|CELSIUS/DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2016|09/21/2016|||OK30|Transfer of the extrusion process for the Proximal Reinforcing Sleeve subcomponent.
P990025|S050|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING|NAVISTAR ELECTROPHYSIOLOGY CATHETER|DRF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2016|09/21/2016|||OK30|Transfer of the extrusion process for the Proximal Reinforcing Sleeve subcomponent.
P010068|S052|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|NAVISTAR DS ELECTROPHYSIOLOGY CATHETER|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2016|09/21/2016|||OK30|Transfer of the extrusion process for the Proximal Reinforcing Sleeve subcomponent.
P030031|S077|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|EZ STEER THERMOCOOL NAVIGATION AND THERMOCOOL BI-DIRECTIONAL CATHETER;THERMOCOOL SF/SF NAV BI-DIRECTIONAL AND SF/SF NAV|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2016|09/21/2016|||OK30|Transfer of the extrusion process for the Proximal Reinforcing Sleeve subcomponent.
P040036|S057|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||Cardiac ablation percutaneous catheter|THERMOCOOL SMART TOUCH BI-DIRECTIONAL AND ELECTROPHYSIOLOGY|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2016|09/21/2016|||OK30|Transfer of the extrusion process for the Proximal Reinforcing Sleeve subcomponent.
P130019|S010|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2016|09/20/2016|||OK30|Material change for the flux used during in-process rework, updated inspection steps, and clarified process instructions for the Model 2002 Rechargeable Neuroregulator.
N12159|S039|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL ABSORBABLE HEMOSTAT|LMG|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2016|09/20/2016|||APPR|Approval for the addition of second sensor on the band sealing equipment that seals the open side of the foil pouch of the SURGICEL Family of Absorbable Hemostats and GYNECARE INTERCEED Absorbable Adhesion Barrier products manufactured at Ethicon, Sarl.
P880047|S023|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/26/2016|09/20/2016|||APPR|Approval for the addition of second sensor on the band sealing equipment that seals the open side of the foil pouch of the SURGICEL Family of Absorbable Hemostats and GYNECARE INTERCEED Absorbable Adhesion Barrier products manufactured at Ethicon, Sarl.
P000025|S090|MED-EL CORP.|FURSTENWEG 77A||INNSBRUCK||A-602|6020|IMPLANT, COCHLEAR|Mi1200 Magnet Assembly|MCM|EN|Real-Time Process|Change Design/Components/Specifications/Material|N|08/29/2016|11/22/2016|||APPR|Approval for the addition of a spring ring inside the magnet housing of the implanted Mi1200 Magnet Assembly.
P090022|S028|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/22/2016|||OK30|Inclusion of one additional steam sterilizer unit for use in the sterilization of the IOLs.
P890055|S065|CODMAN|325 PARAMOUNT DR.||RAYNHAM|MA|02767||PUMP, INFUSION, IMPLANTED, PROGRAMMABLE|CODMAN 3000 CONSTANT-FLOW IMPLANTABLE INFUSION PUMP|LKK|HO|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/26/2016|||OK30|Use a suture material for the Codman 3000 Implantable Infusion Pump from a supplier that has changed ownership from Sherwood Davis & Geck to Medtronic.
P090022|S029|LENSTEC, INC.|1765 COMMERCE AVE N||ST. PETERSBURG|FL|33716||intraocular lens|LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/28/2016|||OK30|Addition of a dishwasher for use in the removal of microbial contamination from packaging and device components used in the manufacture of the LENSTEC Softec Posterior Chamber IOLs.
P140031|S023|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|SAPIEN 3 TRANSCATHETER HEART VALVE|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/25/2016|||OK30|Implementation of an upgraded laser for the manufacture of SAPIEN 3 Transcatheter Heart Valve frames at the Draper, Utah facility.
P830061|S133|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSure Sense Lead Models 4074, 4574|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/21/2016|||OK30|Transfer of the vacuum annealing process to the Medtronic Singapore Operations facility.
P930039|S157|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSureFix Novus Lead Model 4076|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/21/2016|||OK30|Transfer of the vacuum annealing process to the Medtronic Singapore Operations facility.
P130012|S002|Greatbatch Medical|2300 BERKSHIRE LANE NORTH||MINNEAPOLIS|MN|55441||permanent pacemaker Electrode|MYOPORE SUTURELESS MYOCARDIAL PACING LEAD|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/27/2016|||OK30|Use of a new anode plate former.
P040044|S074|ACCESS CLOSURE, INC.|5452 BETSY ROSS DRIVE||SANTA CLARA|CA|95054||Device, hemostasis, vascular|MYNXGRIP AND MYNX ACE VASCULAR CLOSURE DEVICE|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/23/2016|||OK30|Qualify a new supplier for the stopcock component.
P040024|S092|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|RESTYLANE INJECTABLE GEL|LMH|SU|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|10/25/2016|||APPR|Approval for changes to the distribution systems for Water for Injection (WFI) and compressed air.
P880047|S024|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/29/2016|09/27/2016|||OK30|Implementation of a new piece of automatic slitting equipment for the GYNECARE INTERCEED Absorbable Adhesion Barrier.
P140031|S024|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|Edwards Certitude Delivery System|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|08/30/2016|12/02/2016|||APPR|Approval for the Edwards Certitude Delivery System and the Edwards Certitude Introducer Sheath Set.
P880086|S275|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||implantable pacemaker Pulse-generator|Assurity, Assurity+, Endurity, Endurity Core|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2016|09/27/2016|||OK30|Implementation of an automated test solution for hybrid assemblies.
P030035|S149|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|Allure, Allure Quadra, Quadra Allure MP|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/30/2016|09/27/2016|||OK30|Implementation of an automated test solution for hybrid assemblies.
P000037|S047|On-X Life Technologies, Inc.|1655 ROBERTS BLVD NW||KENNESAW|GA|30144||HEART-VALVE, MECHANICAL|ON-X  PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2016|09/28/2016|||OK30|Change to the secondary supplier for the valve holder and holder handle material.
P030017|S257|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Precision Spectra & Novi Spinal Cord Stimulator (SCS) Systems; Precision Montage MRI and Precision Montage Spinal Cord S|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2016|09/29/2016|||OK30|Modify the software used to test the printed circuit board assembly in the Remote Control of your Spinal Cord Stimulation systems.
P000058|S062|Medtronic Sofamor Danek USA, Inc.|1800 Pyramid Place||Memphis|TN|38132||FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION|INFUSE BONE GRAFT; CLYDESDALE SPINAL SYSTEM|NEK|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/31/2016|09/29/2016|||OK30|Alternate inspection methods for the Clydesdale Spinal System 18mm implant; 2) alternate manufacturing equipment for the Clydesdale Spinal System; and 3) the option to perform some manufacturing steps for the Clydesdale Spinal System 22mm implant in-house.
P010030|S081|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LifeVest Wearable Defibrillator|MVK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|08/31/2016|11/30/2016|||APPR|approval for an alternate foam material used in the Electrode Belt
P840001|S343|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead|LGW|NE|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|08/31/2016|09/28/2016|||APPR|Approval for updates to the labeling for the Medtronic Specify 5-6-5 and 2x8 surgical leads to clarify that these are not intended for test stimulation outside of the operating room.
P110008|S006|PARADIGM SPINE, LLC|505 PARK AVENUE, 14TH  FLOOR||NEW YORK|NY|10022||Prosthesis, spinous process spacer/plate|coflex® Interlaminar Technology|NQO|OR|Real-Time Process|Change Design/Components/Specifications/Material|N|09/01/2016|11/30/2016|||APPR|approval for a change to the coflex® labeling to indicate a 5-year shelf-life for coflex® devices manufactured by the second source manufacturer, Orchid.
P050039|S020|EXACTECH, INC.|2320 N.W. 66TH CT.||GAINESVILLE|FL|32653||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|NOVATION CERAMIC ARTICULATION HIP SYSTEM|MRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2016|09/28/2016|||OK30|Add a dryer to the implant drying process.
P100046|S008|ATRICURE INC.|386 WEST MAIN STREET, SUITE 7||NORTHBOROUGH|MA|01532||Surgical cardiac ablation device, for treatment of atrial fibrillation|ATRICURE SYNERGY ABLATION SYSTEM|OCM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2016|10/05/2016|||OK30|Add an additional site for citric passivating the proximal jaws of the end effector on the OLL2 and OSL2 Synergy Ablation Clamps.
P130030|S030|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2016|09/27/2016|||OK30|Introduce a new crimping machine for the marker band securement process.
P950020|S075|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|WOLVERINE CORONARY CUTTING BALLOON MONORAIL, OVER-THE WIRE.|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/01/2016|09/27/2016|||OK30|Introduce a new crimping machine for the marker band securement process.
P980024|S015|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM|PATHVYSION HER-2 DNA PROBE KIT|MVD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Location change for a component supplier.
P030052|S018|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018|||UROVYSION BLADDER CANCER KIT||PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Location change for a component supplier.
P110012|S011|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|Vysis ALK Break Apart FISH Probe Kit|OWE|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Location change for a component supplier.
N12159|S040|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL Family of ABSORBABLE HEMOSTAT|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Implementation of a new piece of automatic cutting equipment for the SURGICEL Original, Nu-Knit and Fibrillar Absorbable Hemostat devices.
P150001|S001|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Artificial pancreas device system, threshold suspend|MiniMed 630G Pump|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/30/2016|||OK30|Relocation of the injection molding process for the 630G insulin pump case sub-assembly to a new manufacturing location. The insulin pump is a component of the MiniMed 630G System.
P980050|S106|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P010015|S307|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN BIPOLAR OTW AND OTW LV LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P060039|S072|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN STARFIX LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P080006|S098|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY LEAD; ATTAIN PERFORMA LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P090013|S234|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P830061|S134|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE SENSE LEAD; CAPSURE SP NOVUS LEAD; VITATRON CYRSTALLINE LEAD; VITATRON EXCELLENCE PS+ LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
N970003|S194|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ADVANTIO; INGENIO; VITALIO; FORMIO; ESSENTIO; PROPONENT; ACCOLADE; ALTRUA 2 PACEMAKERS.|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process.
P850089|S119|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS LEADS, VITATRON IMPULSE II LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P890003|S363|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2 LEAD, VITATRON BRILLIANT S+ VVD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P010012|S432|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA CRT-Ds|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process.
P030005|S142|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE; INVIVE CRT-Ps|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process.
P920015|S183|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|SPRINT QUATTRO/SUBCUTANEOUS/TRANSVENE CS/SVC LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P110042|S063|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM; EMBLEM MRI (S-ICD)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process.
P930039|S158|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSUREFIX,CAPSUREFIX NOVUS, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Additional supplier for stylet components.
P150012|S015|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO MRI; PROPONENT MRI; ACCOLADE MRI Pacemakers|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process.
P960040|S380|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA ICDS|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/29/2016|||OK30|Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process.
P030009|S090|MEDTRONIC IRELAND|Parkmore Business Park West||Galway||||STENT, CORONARY|INTEGRITY CORONARY STENT SYSTEM|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Introducing an upgraded laser ablation machine with integrated automated handling.
P110013|S076|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/02/2016|09/28/2016|||OK30|Introducing an upgraded laser ablation machine with integrated automated handling.
P040027|S050|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS ENDOPROSTHESIS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2016|10/05/2016|||OK30|Implementation of an alternate vacuum bond oven for use during manufacturing of the VIATORR TIPS Endoprosthesis and VIATORR TIPS Endoprosthesis with Controlled Expansion.
P820003|S136|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Patient Cable|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2016|09/29/2016|||OK30|Implementation of a user interface to automate interaction with label printing software during packaging and shipping.
P890003|S364|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Analyzer Adaptors, Cable, Patient Cable; ECG Cable, Output Adaptor|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2016|09/29/2016|||OK30|Implementation of a user interface to automate interaction with label printing software during packaging and shipping.
P900061|S141|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Patient Magnet|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2016|09/29/2016|||OK30|Implementation of a user interface to automate interaction with label printing software during packaging and shipping.
P980016|S599|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Patient Magnet|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2016|09/29/2016|||OK30|Implementation of a user interface to automate interaction with label printing software during packaging and shipping.
P030017|S258|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2016|10/05/2016|||OK30|Addition of clarifications to the existing visual inspection criteria for the printed circuit board assembly (PCBA) component of the Precision Spectra Implantable PulseGenerator (IPG).
P110019|S086|ABBOTT VASCULAR|3200 Lakeside Drive||Santa Clara|CA|95054||Coronary drug-eluting stent|XIENCE XPEDITION & ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/06/2016|09/27/2016|||OK30|Change to the catheter process monitoring system.
P020056|S035|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2016|10/07/2016|||APPR|Approval for adding a new mixing specification of ± 2.5 % (by weight) for theplatinum silicone catalyst (Part A) and cross-linked siloxane (Part B) weights, noting that weights vary based on the size of the production run to produce the standard dispersion (P/N 200-003) and the barrier dispersion (P/N 200-004) during the production of breast implant shells.
P040046|S017|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, noninflatable, internal, silicone gel-filled|NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS|FTR|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2016|10/07/2016|||APPR|Approval for adding a new mixing specification of ± 2.5 % (by weight) for theplatinum silicone catalyst (Part A) and cross-linked siloxane (Part B) weights, noting that weights vary based on the size of the production run to produce the standard dispersion (P/N 200-003) and the barrier dispersion (P/N 200-004) during the production of breast implant shells.
P990074|S033|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE BREAST IMPLANTS|FWM|SU|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2016|10/07/2016|||APPR|Approval for adding a new mixing specification of ± 2.5 % (by weight) for theplatinum silicone catalyst (Part A) and cross-linked siloxane (Part B) weights, noting that weights vary based on the size of the production run to produce the standard dispersion (P/N 200-003) and the barrier dispersion (P/N 200-004) during the production of breast implant shells.
P030011|S046|SYNCARDIA SYSTEMS, LLC|1992 E. SILVERLAKE RD.||TUCSON|AZ|85713||Artificial heart|SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART|LOZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/07/2016|10/12/2016|||APPR|Approval for minor design changes to the Motor Controller Printed Circuit Board Assembly (PCBA) for the Companion 2 Driver System.
P140018|S004|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||Agent, occluding, vascular, permanent|VENASEAL CLOSURE SYSTEM|PJQ|CV|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2016|10/21/2016|||APPR|Approval for an alternate site located at Medtronic, Ireland, Parkmore Business Park, West Galway, Ireland, to perform finished device final release activities.
P010030|S083|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LifeVest Wearable Defibrillator|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2016|10/13/2016|||OK30|Automate removal of a printed circuit board assembly from the manufacturing array.
P110010|S133|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2016|09/29/2016|||OK30|Replace the black and white camera with a color camera on the Port Bond Inspection Station.
P150003|S020|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/07/2016|09/29/2016|||OK30|Replace the black and white camera with a color camera on the Port Bond Inspection Station.
P150023|S005|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||Absorbable coronary drug-eluting stent|ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM|PNY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2016|10/07/2016|||OK30|Update transportation methods to and from the contract sterilizer and to update the configuration for sterilization processing at the contract sterilizer.
P980016|S600|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI; S DR,VR;XT DR,VR, ICD; Intrinsic 30 ICD; Marquis VR ICD; Maximo II ICD; Protecta XT ICD; Secura ICD; Virtuoso|LWS|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2016|11/17/2016|||APPR|Approval for software modification to the MyCareLink Patient Monitor Model 24950.
P980035|S474|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Versa, Sensia IPG; Advisa DR MRI IPG; EnPulse E1,E2 IPG; Kappa D (Kappa 700,900) IPG; Kappa DR (Kappa 650/700/60|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2016|11/17/2016|||APPR|Approval for software modification to the MyCareLink Patient Monitor Model 24950.
P010015|S308|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Consulta, Syncra, Viva CRT-P|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2016|11/17/2016|||APPR|Approval for software modification to the MyCareLink Patient Monitor Model 24950.
P010031|S560|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Brava CRT-D; Brava Quad CRT-D; Concerto ICD,II CRT-D; Consulta CRT-D; InSync II Protect ICD; Maximo II CRT-D; Protecta X|NIK|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2016|11/17/2016|||APPR|Approval for software modification to the MyCareLink Patient Monitor Model 24950.
P090013|S235|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|REVO MRI SURESCAN IPG|LWP|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2016|11/17/2016|||APPR|Approval for software modification to the MyCareLink Patient Monitor Model 24950.
P890003|S365|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|MyCareLink Patient Monitor Model 24950|NVZ|CV|Real-Time Process|Change Design/Components/Specifications/Material|N|09/08/2016|11/17/2016|||APPR|Approval for software modification to the MyCareLink Patient Monitor Model 24950.
P110016|S036|St. Jude Medical, Inc.|2375 MORSE AVENUE||IRVINE|CA|92614|6233|catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|FlexAbility Ablation Catheter (Bi-Directional)|OAD|CV|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2016|10/07/2016|||APPR|Approval to add a manufacturing step to the handle assembly process to the Flexability bi-directional catheter.
P120020|S015|ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)|3200 Lakeside Drive||Santa Clara|CA|95054||STENT, SUPERFICIAL FEMORAL ARTERY|SUPERA PERIPHERAL STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/08/2016|10/06/2016|||OK30|Changes to the sampling for lot release testing.
P060037|S047|ZIMMER, INC.|P.O. Box 708||Warsaw|IN|46581|0708|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM|NJL|OR|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/08/2016|11/16/2016|||APPR|Approval of the revised protocol for the post-approval study (PAS).
P980040|S074|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|TECNIS 1-Piece Multifocal IOLs; TECNIS Symfony Extended Range of Vision (EVR) IOL., TECNIS Symfony Toric ERV IOLs|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2016|10/04/2016|||OK30|Modification to and qualification for a new supplier for the PMMA tumbling cups used in IOL manufacturing.
P030017|S259|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA  SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2016|10/06/2016|||OK30|Use of an alternate bonding method during the manufacture of the charging coil, an electronic component on the Printed Circuit Board Assembly (PCBA) of the Precision Spectra Implantable Pulse Generator (IPG).
P990037|S034|Vascular Solutions, Inc.|6464 SYCAMORE COURT NORTH||MINNEAPOLIS|MN|55369||Device, hemostasis, vascular|D-Stat Flowable hemostat|MGB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2016|10/05/2016|||OK30|Implement renovations to controlled environmental areas within the same facility.
P160004|S001|W. L. GORE & ASSOCIATES, INC.|3250 WEST KILTIE LANE||FLAGSTAFF|AZ|86005||STENT, SUPERFICIAL FEMORAL ARTERY|GORE TIGRIS VASCULAR STENT|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/09/2016|10/05/2016|||OK30|New manufacturing equipment and process settings.
P960040|S381|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/12/2016|||OK30|Addition of an alternate sterilization cycle for pulse generators.
P110012|S012|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement|VYSIS ALK BREAK APART FISH PROBE KIT.|OWE|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/11/2016|||OK30|Manufacturing change with updates on ThermoBrite instrument.
P030052|S019|ABBOTT MOLECULAR|1300 E. Touhy Avenue||Des Plaines|IL|60018||Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence|URO VYSION BLADDER CANCER KIT|NSD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/11/2016|||OK30|Manufacturing change with updates on ThermoBrite instrument.
P010012|S433|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 NG3 CRT-D; INCEPTA, ENERGEN, PUNCTUA PROGENY CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/12/2016|||OK30|Addition of an alternate sterilization cycle for pulse generators.
N970003|S195|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|INGENIO 2, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA PACEMAKERS; ADVANTIO, INGENIO, VITALIO, FORMIO (IPG)|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/12/2016|||OK30|Addition of an alternate sterilization cycle for pulse generators.
P030005|S143|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|INVIVE, INTUA, INGENIO 2, VALITUDE, VALITUDE X4 CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/12/2016|||OK30|Addition of an alternate sterilization cycle for pulse generators.
P110042|S064|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM AND EMBLEM MRI S-ICD SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/12/2016|||OK30|Addition of an alternate sterilization cycle for pulse generators.
P150012|S016|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE PACEMAKER|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/12/2016|||OK30|Addition of an alternate sterilization cycle for pulse generators.
P010015|S309|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Attain Bipolar OTW Lead|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/06/2016|||OK30|Consolidation and transfer of the supplier location for extrusion activities for tubing components.
P060039|S073|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN STARFIX MODEL 4195 LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/06/2016|||OK30|Consolidation and transfer of the supplier location for extrusion activities for tubing components.
P080006|S099|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|Attain Ability, Performa Lead 4298,|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/06/2016|||OK30|Consolidation and transfer of the supplier location for extrusion activities for tubing components.
P830061|S135|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSure Sense, SP Novus Lead: Vitatron Crystalline, Excellence PS+ Lead;|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/06/2016|||OK30|Consolidation and transfer of the supplier location for extrusion activities for tubing components.
P920015|S184|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|HV splitter/adaptor kit; Sprint Quattro Lead|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/06/2016|||OK30|Consolidation and transfer of the supplier location for extrusion activities for tubing components.
P930039|S159|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSureFix Novus Lead; Vitatron Crystalline; Active Fixation Lead|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/06/2016|||OK30|Consolidation and transfer of the supplier location for extrusion activities for tubing components.
P100001|S009|ORTHO-CLINICAL DIAGNOSTICS|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/10/2016|||OK30|Production scale-up of a raw material used in the formulation of the VITROS reagents.
P140010|S025|MEDTRONIC Inc.|3576 UNOCAL PL||SANTA ROSA|CA|95403||Drug-Eluting Peripheral Transluminal Angioplasty Catheter|IN PACT ADMIRAL PACLITAXEL-COATED BALLOON CATHETER|ONU|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/07/2016|||OK30|Manufacture the 150 mm length device on an additional, existing manufacturing line.
P900056|S155|Boston Scientific Corp.|TWO SCIMED PLACE||MAPLE GROVE|MN|55311|1566|CATHETER, CORONARY, ATHERECTOMY|Rotablator Rotational Atherectomy System|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/12/2016|10/11/2016|||OK30|Transfer manufacturing for the RotaWire Floppy Core Wires component from the approved vendor, Lake Region Medical Arvada to Lake Region Medical Galway.
P940019|S048|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT ENDOPROSTHESIS LLIAC|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2016|10/12/2016|||OK30|Equipment update to automate features and implementation of a manufacturing database.
P930031|S057|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT ENDOPROSTHESIS TIPS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2016|10/12/2016|||OK30|Equipment update to automate features and implementation of a manufacturing database.
P980033|S046|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDOPROSTHESIS VENOUS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2016|10/12/2016|||OK30|Equipment update to automate features and implementation of a manufacturing database.
P030054|S310|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QuickFlex U|NIK|CV|135 Review Track For 30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2016|10/26/2016|||APPR|Approval for crimping process changes.
P040045|S057|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (senofilcon A) Brand Contact Lenses|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2016|10/07/2016|||OK30|Alternate supplier of a raw material component of the VISTAKON® senofilcon A Brand Contact Lenses.
P080011|S046|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY ENERGY ASPHERE|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/13/2016|10/05/2016|||OK30|Validation of Biofinity Line 17 at the CooperVision Inc. Hamble, UK manufacturing facility to produce Biofinity Energys Asphere plus power lenses (+0.25D to +8.00D).
P050006|S052|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE CARDIOFORM SEPTAL OCCLUDER|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2016|10/13/2016|||OK30|Addition of an annealing process step to two extrusions of the Delivery System Control Catheter.
P870080|S002|RICHARD WOLF MEDICAL INSTRUMENTS CORP.|353 CORPORATE WOODS PKWY.||VERNON HILLS|IL|60061||Laparoscopic contraceptive tubal occlusion device|HULKA CLIP FOR TUBAL OCCLUSION|KNH|OB|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|08/22/2016|10/14/2016|||OK30|Manufacturing process change involving the replacement of a manual cleaning process with an ultrasonic cleaning process.
P130008|S015|INSPIRE MEDICAL SYSTEMS|9700 63RD AVENUE NORTH|SUITE 200|MAPLE GROVE|MN|55369||Stimulator, hypoglossal nerve, implanted, apnea|INSPIRE II IMPLANTABLE PULSE GENERATOR|MNQ|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/14/2016|10/14/2016|||OK30|Implement a change to the manufacturing procedure for annealing of the Model 3024 implantable pulse generator (IPG), which adds an in-house annealing process at 1st tier supplier Greatbatch Medical Minneapolis (GMM).
P010031|S561|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia, Brava, Compia, Concerto II. Consulta, Maximo II, Protecta, Protecta XT, Viva S,XT, Quad CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2016|10/04/2016|||OK30|Update to the manufacturing inspection process for feedthrough assemblies.
P980016|S601|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera S, Maximo II, Protecta, Secura,Quad XT CRT-D; Virtuoso II, Visia AF, MRI VR ICD,|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/15/2016|10/04/2016|||OK30|Update to the manufacturing inspection process for feedthrough assemblies.
P110042|S065|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR DEVICE  (S-ICD) SYSTEM EMBLEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2016|10/13/2016|||OK30|Automate the process of applying medical adhesive to the battery feedthru assembly.
P960040|S382|BOSTON SCIENTIFIC|4100 Hamline Avenue North||St. Paul|MN|55112||Implantable cardioverter defibrillator (non-CRT)|IMPLANTABLE CARDIOVETER DEFIBRILLATOR, DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA MINI, EL, ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2016|10/13/2016|||OK30|Automate the process of applying medical adhesive to the battery feedthru assembly.
P010012|S434|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DYNAGEN, INOGEN, ORIGEN, X4 CRT-D:|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2016|10/13/2016|||OK30|Automate the process of applying medical adhesive to the battery feedthru assembly.
P110038|S014|BOLTON MEDICAL, INC.|799 INTERNATIONAL PARKWAY||SUNRISE|FL|33325||SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/16/2016|10/13/2016|||OK30|Use of an automatic drilling machine in the manufacture of the rotator body component of the Relay Thoracic Stent-Graft Plus Delivery System.
P130007|S022|ANIMAS CORP.|965 CHESTERBROOK BLVD.||WAYNE|PA|19087||Pump, infusion, insulin, to be used with invasive glucose sensor|ANIMAS VIBE SYSTEM|OYC|CH|Real-Time Process|Labeling Change - Indications/instructions/shelf life/tradename|N|09/19/2016|11/05/2016|||APPR|Approval for a change to the Animas Vibe System labeling to specify compatibility with OneTouch infusion sets.
P980022|S195|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|Paradigm REAL-Time Revel Insulin Pump|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2016|10/19/2016|||OK30|Add a new testing station to conduct a manual Displacement Accuracy Test (DAT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps.  These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.
P120010|S095|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G INSULIN PUMP|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2016|10/19/2016|||OK30|Add a new testing station to conduct a manual Displacement Accuracy Test (DAT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps.  These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.
P150019|S020|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|Paradigm REAL-Time Insulin Pump|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2016|10/19/2016|||OK30|Add a new testing station to conduct a manual Displacement Accuracy Test (DAT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps.  These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.
P080011|S047|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY XR TORIC|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2016|10/11/2016|||OK30|Installation and validation of Biofinity MTO production Line 1, collation and packaging module, at the CooperVision, Inc. Hamble, UK manufacturing facility to support post autoclave processing of Biofinity XR Toric.
P080011|S048|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY XR TORIC|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2016|10/11/2016|||OK30|Validation of Biofinity Line 3 at the CooperVision Inc. Hamble, UK manufacturing facility to manufacture Biofinity XR Toric minus power lenses.
P140002|S003|TERUMO MEDICAL CORPORATION|950 ELKTON BLVD||ELKTON|MD|21921||STENT, SUPERFICIAL FEMORAL ARTERY|MISAGO RX SELF-EXPANDING PERIPHERAL STENT|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2016|10/18/2016|||OK30|Modified extrusion process parameters and changes to in-process inspection specifications.
P140002|S004|TERUMO MEDICAL CORPORATION|950 ELKTON BLVD||ELKTON|MD|21921||STENT, SUPERFICIAL FEMORAL ARTERY|MISAGO RX SELF-EXPANDING PERIPHERAL STENT|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/19/2016|10/18/2016|||OK30|Modified processing time for a manufacturing step.
P140013|S004|MINERVA SURGICAL|101 SAGINAW DRIVE||REDWOOD CITY|CA|94063||DEVICE, THERMAL ABLATION, ENDOMETRIAL|MINERVA ENDOMETRIAL ABLATION SYSTEM|MNB|OB|Normal 180 Day Track No User Fee|Location Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2016|11/09/2016|||APPR|Approval for a contract manufacturing site located at Apical Instruments, 2971 Spring Street, Redwood City, CA for the manufacture of the Minerva RF Controller.
P150003|S021|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL (MR)|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2016|10/14/2016|||OK30|Optimize the Port Bond station inspection process to improve operator efficiency.
P110010|S134|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Coronary drug-eluting stent|PROMUS(ELEMENT PLUS/PREMIER)  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/20/2016|10/14/2016|||OK30|Optimize the Port Bond station inspection process to improve operator efficiency.
P010014|S056|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|Oxford Partial Knee System|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2016|10/21/2016|||APPR|Approval to update the instructions provided on preoperative size selection of the femoral component and its cementing technique, within the approved surgical technique for the Oxford Partial Knee System.
P140002|S005|TERUMO MEDICAL CORPORATION|950 ELKTON BLVD||ELKTON|MD|21921||STENT, SUPERFICIAL FEMORAL ARTERY|MISAGO RX Self-expanding Peripheral Stent|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2016|10/14/2016|||OK30|Supplier relocation and equipment change.
P120011|S007|IDEALIMPLANT|5005 LBJ FREEWAY SUITE 900||DALLAS,|TX|75244||Prosthesis, breast, inflatable, internal, saline|IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/21/2016|10/20/2016|||OK30|Extra valve competence testing on valves prior to assembly into implants, implemented during commercial production start-up, will be discontinued; andthe extra valve competence testing on valves in finished (i.e., packaged and sterilized) implants during commercial production start-up, will be discontinued.  However, valve competence testing on valves in finished implants will continue to meet the requirements of the AQL sampling specified in Ideal Implant’s Finished Product Specification FP 001.
P970051|S150|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||IMPLANT, COCHLEAR|NUCLEUS COCHLEAR IMPLANT SYSTEM|MCM|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/21/2016|||OK30|Introduction of a formal tool to measure the Q and tuned frequency of a finished implant in the Nucleus Cochlear Implant System and the Nucleus Auditory Brainstem Implant System.
P000015|S015|Cochlear Americas|13059 EAST PEAKVIEW AVENUE||Centennial|CO|80111||Implant, auditory brainstem|NUCLEUS AUDITORY BRAINSTEM IMPLANT|MHE|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/21/2016|||OK30|Introduction of a formal tool to measure the Q and tuned frequency of a finished implant in the Nucleus Cochlear Implant System and the Nucleus Auditory Brainstem Implant System.
P040045|S058|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/12/2016|||OK30|Implementation of an alternate raw material supplier for VISTAKON® (senofilcon A); ACUVUE OASYS® Brand Contact Lenses.
P050028|S054|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Hepatitis Viral B DNA Detection|COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/18/2016|||OK30|Implementation of AQL sampling in place of online 100% visual inspection for vials filled on 3 high-speed filling lines.
P060030|S055|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS|COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0|MZP|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/18/2016|||OK30|Implementation of AQL sampling in place of online 100% visual inspection for vials filled on 3 high-speed filling lines.
P100020|S021|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS|COBAS HPV TEST|MAQ|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/18/2016|||OK30|Implementation of AQL sampling in place of online 100% visual inspection for vials filled on 3 high-speed filling lines.
P110037|S029|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Cytomegalovirus (cmv) dna quantitative assay|COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test|PAB|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/18/2016|||OK30|Implementation of AQL sampling in place of online 100% visual inspection for vials filled on 3 high-speed filling lines.
P120019|S012|ROCHE|4300 HACIENDA DRIVE|PO BOX 9002|PLEASANTON|CA|94588||Somatic gene mutation detection system|cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/19/2016|||OK30|Implementation of AQL sampling in place of 100% visual inspection for filling line.
P140023|S008|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|COBAS KRAS MUTATION TEST|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/19/2016|||OK30|Implementation of AQL sampling in place of 100% visual inspection for filling line.
P150047|S002|Roche Molecular Systems, Inc.|4300 Hacienda Drive||Pleasanton|CA|94588|2722|Somatic gene mutation detection system|Cobas EGFR MUTATION TEST v2|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/19/2016|||OK30|Implementation of AQL sampling in place of 100% visual inspection for filling line.
P920015|S185|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|MEDTRONIC(R) TRANSVENE LEAD SYSTEM|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/17/2016|||OK30|Changes to bioburden and bacterial endotoxin testing.
P900061|S142|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/17/2016|||OK30|Changes to bioburden and bacterial endotoxin testing.
P010014|S057|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|OXFORD PARTIAL KNEE SYSTEM|NRA|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/13/2016|||OK30|Addition of a new material supplier.
P870078|S033|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/22/2016|10/19/2016|||OK30|Relocation of the manufacturing facility for the conduit supplier.
P090013|S236|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CapSureFix MRI Lead 5086MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2016|10/16/2016|||OK30|Additional laser workstations for leads welding operations.
P930039|S160|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CapSureFix Novus Lead 4076, 5076|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2016|10/16/2016|||OK30|Additional laser workstations for leads welding operations.
P980023|S078|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||Implantable cardioverter defibrillator (non-CRT)|Permanent defibrillator electrodes|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2016|10/03/2016|||OK30|Changes to the in-process quality inspection criteria for Protego leads.
P950037|S168|BIOTRONIK, INC.|6024 Jean Road||Lake Oswego|OR|97035||implantable pacemaker Pulse-generator|Reocor S, Reocor D|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2016|10/21/2016|||OK30|Update of the production test software for the printed circuit board measurement stations from version 1.2.1.0 to 1.3.0.0.
P010047|S044|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|PROGEL PLEURAL AIR LEAK SEALANT|NBE|AN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/23/2016|10/20/2016|||OK30|Removal of the temperature indicator located on the Chemistry Kit component of the Pro gel Pleural Air Leak Sealant.
P980035|S476|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Verds, Sensia IPG ; Advisa DR IPG; Advisa DR & SR MRI IPG; Relia IPG|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/24/2016|||OK30|Extension of a continuous monitoring system for non-controlled manufacturing areas.
P010031|S562|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad CRT-D, Compia MRI CRT-D & Quad CRT-D, Concerto II CRT-D, Consulta CRT-|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/24/2016|||OK30|Extension of a continuous monitoring system for non-controlled manufacturing areas.
P090013|S237|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Reno MRI SureScan IPG|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/24/2016|||OK30|Extension of a continuous monitoring system for non-controlled manufacturing areas.
P150033|S007|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|Micra TPS|PNJ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/24/2016|||OK30|Extension of a continuous monitoring system for non-controlled manufacturing areas.
P980016|S602|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI, S DR, S VR, XT DR, XT VR ICD'S; Maximo Ii ICD; Protecta ICD, XT ICD; Secura DR ICD, Secura ICD; Virtuoso II D|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/24/2016|||OK30|Extension of a continuous monitoring system for non-controlled manufacturing areas.
P010015|S310|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Consulta CRT0P, Syncra CRT-P, Viva CRT-P|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/24/2016|||OK30|Extension of a continuous monitoring system for non-controlled manufacturing areas.
P050034|S017|VISIONCARE, INC.|14395 SARATOGA AVENUE #150||SARATOGA|CA|95070||Telescope, implantable, miniature|IMPLANTABLE MINIATURE TELESCOPE (IMT)|NCJ|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/20/2016|||OK30|Modification to the inspection method for the optical surface of the telescope.
P880047|S025|ETHICON, INC.|ROUTE 22 WEST|P.O. BOX 151|SOMERVILLE|NJ|08876|0151|BARRIER, ABSORABLE, ADHESION|GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER|MCN|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/26/2016|10/26/2016|||APPR|Approval for modification of the warning statement corresponding to use of the subject device in a contaminated surgical site.
P030017|S260|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/26/2016|||OK30|Addition of an alternate qualified supplier of the Charger printed circuit board assembly for your Precision family of spinal cord stimulation systems.
P050006|S053|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|Gore CARDIOFORM Septal Occluder|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/25/2016|||OK30|Addition of an alternate winding machine for use in winding the wire frame of the Gore Cardioform Septal Occluder.
P140012|S005|RESHAPE MEDICAL, INC.|100 CALLE IGLESIA||SAN CLEMENTE|CA|92672||IMPLANT, INTRAGASTRIC FOR MORBID OBESITY|RESHAPE INTEGRATED DUAL BALLOON SYSTEM|LTI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/26/2016|10/25/2016|||OK30|Addition of an inspection step (spin test) during commercial manufacturing and quality control activities.
P980016|S603|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AF MRI VR ICD & Visia AF VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2016|10/24/2016|||OK30|Addition of a laser marker removal process to allow for rework on ICD and CRT-D shields.
P010031|S564|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Amplia MRI CRT-D & QUAD CRT-D, Brava CRT-D, Brava Quad CRT-D, Compia MRI CRT-D & MRI Quad CRT-D, Viva Quad S & XT CRT-D'|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2016|10/24/2016|||OK30|Addition of a laser marker removal process to allow for rework on ICD and CRT-D shields.
P030017|S261|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Precision, Precision Spectra, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulator (SCS) S|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2016|10/26/2016|||OK30|Minor manufacturing process updates at the current supplier of cables, Heraeus Singapore Facility.
N12159|S041|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FAMILY OF ABSORBABLE HEMOSTATS|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2016|10/24/2016|||OK30|Addition of filling/ folding stations. The production capacity of the room increased to allowing 36 operators to perform the existing process at the same time. The above change is located at room 217 in Puits Godet20, Neochatel CH-2000, Switzerland.
N12159|S042|ETHICON, INC.|ROUTE 22 WEST||SOMERVILLE|NJ|08876||Agent, absorbable hemostatic, non-collagen based|SURGICEL FAMILY OF ABSORBABLE HEMOSTATS|LMG|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/27/2016|10/25/2016|||OK30|Approval for the Bergami G10102 transferred to room 221 and re-qualified to overwrap US SURGICEL product codes, which includes medium and large carton boxes. The above change is located at room 221 in Puits Godet20, Neochatel CH-2000, Switzerland
P100044|S024|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL, PROPEL MINI SINUS IMPLANT|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2016|10/28/2016|||OK30|Implementation of alternate analytical testing facilities for finished goods and components used in the manufacture of the Propel and Propel Mini Sinus Implants.
P040045|S059|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON SENOFILCON A BRAND CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2016|10/20/2016|||OK30|Discontinuation of an in-process packing solution monitoring test.
P010015|S311|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CONSULTA/SYNCRA/VIVA CRT-Ps|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2016|10/18/2016|||OK30|Supplier process change for the over etch time.
P010031|S565|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT CRT-Ds|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2016|10/18/2016|||OK30|Supplier process change for the over etch time.
P970004|S229|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2016|10/24/2016|||OK30|Addition of an inspection for a concentricity requirement to the strain relief part of the InterStim II Model 3058.
P980016|S604|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRTUOSO II DR/VR ICDs|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2016|10/18/2016|||OK30|Supplier process change for the over etch time.
P080025|S124|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM FOR BOWEL CONTROL|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2016|10/24/2016|||OK30|Addition of an inspection for a concentricity requirement to the strain relief part of the InterStim II Model 3058.
P980035|S477|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|ADAPTA/VERSA/SENSIA/ADVISA DR/ADVISA DR MRI/ADVISA SR MRI/RELIA IPGs|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/28/2016|10/18/2016|||OK30|Supplier process change for the over etch time.
P040003|S019|INSIGHTEC, LTD|4851 LBJ FRWY, STE 400||DALLAS|TX|75244||Ablation system, high intensity focused ultrasound (hifu), mr-guided|InSightec ExAblate System|NRZ|OB|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/28/2016|10/28/2016|||APPR|Approval for the addition of adenomyosis to the list of conditions for which the safety and effectiveness of ExAblate have not been evaluated.
P110023|S021|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)|NIP|CV|Normal 180 Day Track No User Fee|Postapproval Study Protocol - OSB|N|09/28/2016|11/23/2016|||APPR|Approval to decrease the sample size in the post-approval study protocol.
P100049|S018|TORAX MEDICAL|4188 LEXINGTON AVENUE NORTH||SHOREVIEW|MN|55126||IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX|LINX REFLUX MANAGEMENT SYSTEM, IMPLANT AND SIZING TOOL|LEI|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2016|10/20/2016|||OK30|Revised labeling process of printing labels on a single sheet label stock, per device.
P000053|S068|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEM & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2016|10/21/2016|||OK30|Work instruction updates and inspections of the AMS 800 Pressure Regulating Balloon (PRB) Assembly.
P940015|S037|GENZYME CORP.|55 CAMBRIDGE PARKWAY|4TH FLOOR|CAMBRIDGE|MA|02142||Acid, hyaluronic, intraarticular|SYNVISC|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2016|11/08/2016|||OK30|Qualification of Synvisc and Synvisc-One syringe labels from alternate approved suppliers.
P150033|S008|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM|PNJ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2016|10/26/2016|||OK30|Addition of a manufacturing line at the Swiss Manufacturing Operations facility.
P810002|S098|St. Jude Medical, Inc.|ONE LILLEHEI PLAZA||ST. PAUL|MN|55117||HEART-VALVE, MECHANICAL|SJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit|LWQ|CV|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2016|12/01/2016|||APPR|Approval for revisions to the MRI safety labeling.
P030031|S078|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|The ThermoCool SmartTouch SF Uni-Directional & Bi-Directional Navigational Catheter|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/29/2016|10/27/2016|||OK30|Transfer of the extrusion process of the Reinforcing Sleeve subcomponent.
P950029|S112|SORIN GROUP- CRM|4 AVENUE REAUMUR||CLAMART CEDEX||92140||implantable pacemaker Pulse-generator|Repy SR/DR & Esprit SR/DR Pacemakers|DXY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/01/2016|10/25/2016|||OK30|Process updates in the microelectronics assembly manufacturing line and the addition of new equipment for resin coating.
P130019|S011|ENTEROMEDICS INC.|2800 PATTON ROAD||SAINT PAUL|MN|55113||neuromodulator for obesity|MAESTRO RECHARGEABLE SYSTEM|PIM|GU|Real-Time Process|Change Design/Components/Specifications/Material|N|09/29/2016|11/21/2016|||APPR|Approval for updates to the application firmware (v5.09) used in the Model 2402 mobile charger.
P070014|S052|BARD PERIPHERAL VASCULAR, INC.|1415 WEST 3RD ST.||TEMPE|AZ|85281||STENT, SUPERFICIAL FEMORAL ARTERY|LIFESTENT VASCULAR STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2016|10/28/2016|||OK30|Minor change to the bacterial endotoxin testing.
P150003|S022|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2016|10/26/2016|||OK30|Change the SYNERGY delivery system manufacturing process.
P100044|S025|INTERSECT ENT|1555 ADAMS DR||MENLO PARK|CA|94025||Drug-eluting sinus stent|PROPEL SINUS, MINI SINUS IMPLANT.|OWO|EN|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2016|10/28/2016|||OK30|Modify the incoming quality assurance test method and associated acceptance criteria for the tensile test for the monofilament fiber component in Propel and Propel Mini Sinus Implants.
P990074|S034|Allergan|2525 DUPONT DR.||IRVINE|CA|92612||Prosthesis, breast, inflatable, internal, saline|NATRELLE SALINE FILLED BREAST IMPLANTS|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2016|10/20/2016|||OK30|Change to the worst case device of the BIOCELL-textured, Natrelle Saline-Filled Breast Implant product line, for representative bioburden testing.
P040045|S060|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BAND CONTACT LENS,|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2016|10/27/2016|||OK30|Introduce a new injection molding machine (IMM), Sumitomo dual IMM, to produce front curve and back curve molds for VISTAKON® (senofilcon A) Brand Contact Lenses.
P100045|S011|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF SYSTEM|MOM|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|09/30/2016|10/19/2016|||APPR|Approval for changes to the Hospital System Guide for the CardioMEMS HF System to clarify the instructions for powering down the hospital electronics unit (CM3000).
P140021|S007|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0416|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ELECSYS ANTI-HCV II IMMUNOASSAY.|MZO|MI|Real-Time Process|Change Design/Components/Specifications/Material|N|09/30/2016|11/10/2016|||APPR|Approval for the addition of K3-EDTA plasma as a specimen type for the Elecsys® Anti-HCV II Immunoassay.
P150019|S022|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|Paradigm REAL-Time Revel Insulin Pump with Enlite Sensor System|MDS|CH|Real-Time Process|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|09/30/2016|10/13/2016|||APPR|Approval for a modification to the design of the drive support cap of the Paradigm insulin pump.
P140028|S019|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/01/2016|||OK30|Alternate supplier for a manufacturing aid.
P930031|S058|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|WALLSTENT ENDOPROSTHESIS TIPS|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/01/2016|||OK30|Alternate supplier for a manufacturing aid.
P940019|S049|BOSTON SCIENTIFIC SCIMED, INC.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|WALLSTENT ENDOPROSTHESIS ILIAC|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/01/2016|||OK30|Alternate supplier for a manufacturing aid.
P980033|S047|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, CORONARY|WALLSTENT ENDOPROSTHESIS VENOUS|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/01/2016|||OK30|Alternate supplier for a manufacturing aid.
P110035|S038|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, ILIAC|EPIC VASCULAR SELF-EXPANDING STENT SYSTEM|NIO|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/01/2016|||OK30|Alternate supplier for a manufacturing aid.
P020004|S138|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE EXCLUDER AAA Endoprosthesis|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|10/24/2016|||OK30|Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.
P040027|S051|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS Endoprosthesis|MIR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|10/24/2016|||OK30|Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.
P040037|S094|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|10/25/2016|||OK30|Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.
P040043|S087|W. L. GORE & ASSOCIATES, INC.|3450  KILTIE LANE|P.O. BOX 2400|FLAGSTAFF|AZ|86003|2400|SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT|GORE TAG THORACIC ENDOPROSTHESIS|MIH|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|10/24/2016|||OK30|Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.
N970003|S196|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE, ALTRUA2 PACEMAKER MODELS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/03/2016|||OK30|Additional supplier for the raw material used in low voltage battery lids.
P050006|S054|W.L. GORE & ASSOCIATES,INC|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085|1505|Transcatheter septal occluder|GORE CARDIOFORM Septal Occluder;|MLV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|10/24/2016|||OK30|Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.
P030005|S144|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE CRT-P|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/03/2016|||OK30|Additional supplier for the raw material used in low voltage battery lids.
P130006|S033|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|10/24/2016|||OK30|Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.
P150012|S017|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE MRI PACEMAKERS|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/03/2016|||OK30|Additional supplier for the raw material used in low voltage battery lids.
P110042|S066|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD)|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/03/2016|11/01/2016|||OK30|Changes to a battery manufacturing line including component movement, vision system enhancements, and guardband re-calculation.
P010030|S085|ZOLL MANUFACTURING CORPORATION|121 GAMMA DR||PITTSBURGH|PA|15238|0000|Wearable automated external defibrillator|LifeVest Device|MVK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2016|11/03/2016|||OK30|Implementing an alternate testing method for the 4000/4000B electrode belts and re-sequencing of two existing test steps.
P120011|S008|IDEALIMPLANT|5005 LBJ FREEWAY SUITE 900||DALLAS,|TX|75244||Prosthesis, breast, inflatable, internal, saline|IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT|FWM|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2016|11/07/2016|||OK30|Change in the device sampling plan for endotoxin testing.
P120008|S010|Abbott Laboratories|09V6 AP5-2N|100 ABBOTT PARK ROAD|ABBOTT PARK|IL|60064||KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS|ABBOTT ARCHITECT AFP ASSAY|LOK|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2016|10/27/2016|||OK30|Abbott Laboratories requests approval to transfer the manufacturing and testing of two monoclonal antibodies from one Abbott manufacturing site to another.
P910001|S088|SPECTRANETICS CORP.|9965 Federal Drive||Colorado Springs|CO|80921||DEVICE, ANGIOPLASTY, LASER, CORONARY|SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM|LPC|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/04/2016|10/13/2016|||OK30|Replace the vendor of components of the P5 Connector Cable Assembly, the P9 Connector Cable Assembly, and its corresponding 40 pin connector.
P950039|S035|HOLOGIC, INC.|250 Campus Drive||Marlborough|MA|01752||Processor, cervical cytology slide, automated|THINPREP PROCESSOR,|MKQ|PA|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/05/2016|10/26/2016|||APPR|Approval of labeling changes for the ThinPrep® 3000 Processor.
P100047|S084|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Relocation of a supplier for a HeartWare Ventricular Assist Device (HVAD) System component.
P010015|S312|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ATTAIN BIPOLAR OTW AND OTE LV LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P030036|S087|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ANCHORING SLEEVE KIT/SELECTSECURE LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P060039|S074|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN STARFIX LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P080006|S100|MEDTRONIC Inc.|710 MEDTRONIC PARKWAY NE||MINNEAPOLIS|MN|55432||Drug eluting permanent left ventricular (lv) pacemaker electrode|ATTAIN ABILITY/PERFORMA LEAD|OJX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P090013|S238|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|CAPSUREFIX MRI LEAD|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P120017|S006|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||permanent pacemaker Electrode|MYOCARDIAL PACING LEAD|DTB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P830061|S136|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|ADHESIVE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS+ LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P850089|S120|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS/VITATRON IMPULSE II LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P890003|S366|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|CAPSURE VDD 2/SERVICE KIT-PACEMAKER REPAIR KIT/VITATRON BRILLLIANT S+ VDD LEAD|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P900061|S143|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|END CAP/UPSIZING SLEEVE|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P920015|S186|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|DF-1 CONNECTOR PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/SUBCUTANEOUS/TRANSVENCE CS/SVC LEADS|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P930039|S161|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSUREFIX/CAPSUREFIX NOVUS/VITATRON CRYSTALLINE ACTIVE FIXATION LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P950024|S069|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|CAPSURE EPICARDIAL PACING LEAD|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P980050|S107|MEDTRONIC Inc.|8200 CORAL SEA STREET|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|TRANSVENE CS/SVC LEAD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/05/2016|11/02/2016|||OK30|Endotoxin test method changes for leads and accessories.
P040024|S093|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|Restylane, Perlane, Restylane Lyft (formerly Perlane-L), Restylane Silk|LMH|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2016|11/01/2016|||OK30|Addition of a sterilization site for plungers used with Restylane-L 2 mL and Perlane-L 2 mL.
P000053|S070|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS 800 URINARY CONTROL SYSTEMS & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2016|11/01/2016|||OK30|Manufacturing flow and inspection changes or additions to the cuff shell assembly.
P100047|S085|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/06/2016|11/02/2016|||OK30|Implementation of a semi-automated re-machining process for a component of the HeartWare Ventricular Assist Device (HVAD) Pump Assembly.
P980016|S605|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera S DR,VR ICD; Evera XT DR, VR ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2016|11/02/2016|||OK30|Update the final functional test software and the associated electrical test specification.
P010031|S566|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Brava,Brava Quad CRT-D; Viva S, XT,Viva Quad S, XT CRT-D|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2016|11/02/2016|||OK30|Update the final functional test software and the associated electrical test specification.
P150033|S010|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Leadless pacemaker|Micra TPS MC1VR01|PNJ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/07/2016|11/02/2016|||OK30|Alternate printed wiring board manufactured at the suppliers Singapore facility.
P850048|S043|BECKMAN COULTER, INC.|250 SOUTH KRAEMER BLVD M/S|W-110|BREA|CA|92822||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|TANDEM-R PSA IMMUNORADIOMETRIC ASSAY|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2016|11/09/2016|||OK30|Change in the manufacturing process for the conversion from a Hollow Fiber particle coupling process to a Semi-Automated Magnetic separation particle coupling process used for the paramagnetic particles in the Access Hybritech PSA.
P010014|S058|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|Oxford Partial Knee System - Bearing Components|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2016|11/09/2016|||APPR|Approval for an additional inspection check for the Oxford Partial Knee Meniscal Bearing packaging. The additional check will require operators to visually inspect for presence of vacuum and that no movement of product should occur within the vacuum-sealed pouch.
P120005|S056|DEXCOM, INC.|6340 SEQUENCE DR||SAN DIEGO|CA|92121||Sensor, glucose, invasive|DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2016|11/16/2016|||OK30|Two changes that include an improvement to the G5 Mobile/G4 PLATINUM Transmitter machining process that reduces machining time and to introduce a new visual inspection tool. Both changes apply to G4 PLATINUM and G5 Mobile Transmitters.  The Dexcom G5 Mobile/G4 PLATINUM Transmitter is a component of the Dexcom G5 Mobile and the G4 Platinum Continuous Glucose Monitoring System, respectively.
P130009|S065|EDWARDS LIFESCIENCES, LLC.|One Edwards Way||Irvine|CA|92614||Aortic valve, prosthesis, percutaneously delivered|EDWARDS EXPANDABLE INTRODUCER SHEATH SET|NPT|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/11/2016|11/10/2016|||OK30|Implement a software-based measurement system for the strain relief tubing inner diameter.
P960013|S086|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|TENDRIL  SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2016|11/06/2016|||OK30|Alternate analytical testing laboratory for monolithic controlled release devices.
P960030|S048|PACESETTER, INC.|15900 VALLEY VIEW CT.|P.O. BOX 9221|SYLMAR|CA|91392|9221|Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes|IsoFlex Optim Leads|NVN|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2016|11/06/2016|||OK30|Alternate analytical testing laboratory for monolithic controlled release devices.
P030054|S312|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|QuickFlex and Quartet Leads|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2016|11/06/2016|||OK30|Alternate analytical testing laboratory for monolithic controlled release devices.
P950022|S096|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|Durata and Optisure Leads|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2016|11/06/2016|||OK30|Alternate analytical testing laboratory for monolithic controlled release devices.
P160017|S001|MEDTRONIC MINIMED|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325||Artificial pancreas device system, single hormonal control|MiniMed 670G System|OZP|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/12/2016|11/15/2016|||OK30|Relocation of the injection molding process for the 670G insulin pump case sub-assembly to a new manufacturing location. The insulin pump is a component of the MiniMed 670G System.
P130021|S025|MEDTRONIC COREVALVE  LLC|3576 Unocal Place||Santa Rosa|CA|95403||Aortic valve, prosthesis, percutaneously delivered|Medtronic CoreValve Evolut R XL system|NPT|CV|Normal 180 Day Track|Change Design/Components/Specifications/Material|N|10/13/2016|10/26/2016|||APPR|Approval for a new size of the CoreValve Evolut R System. The new components include CoreValve Evolut R Transcatheter Aortic Valve, model EVOLUTR-34-US, EnVeo R Delivery Catheter System, model ENVEOR-N-US, and EnVeo™ R Loading System, model LS-ENVEOR-34-US.
P080011|S050|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY ENERGYS|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/13/2016|11/03/2016|||OK30|Addition of add power measurement for the Biofinity Energys product.
P160017|S002|MEDTRONIC MINIMED|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325||Artificial pancreas device system, single hormonal control|MiniMed 670G Insulin Pump|OZP|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2016|11/10/2016|||OK30|Addition of an alternative manufacturing equipment as part of the Guardian Sensor shim cutting process. The Guardian Sensor is a component of the MiniMed 670G System.
P150001|S002|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Artificial pancreas device system, threshold suspend|Enlite Sensor|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2016|11/08/2016|||OK30|Additional plasma equipment used during manufacture of the Enlite sensor at the Medtronic’s sensor substrate supplier.
P110029|S024|Abbott Laboratories|100 ABBOTT PARK RD.|DEPT 09V6, BLDG. AP5-2|ABBOTT PARK|IL|60064|6088|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY,|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/14/2016|11/10/2016|||OK30|Increase the batch range and modify the pooling allowances for the bulks and concentrates for components used in the ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory Reagents.
P980035|S479|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Advisa DR IPG A4DR01, Advisa DR MRI IPG A2DR01, Advisa SR MRI IPG A3SR01|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2016|11/10/2016|||OK30|Modifications to the case cover laser welding process parameters for the battery component.
P090013|S239|Medtronic, Inc|8200 Coral Sea Street NE||Mounds View|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|Revo MRI SureScan IPG RVDR01|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2016|11/10/2016|||OK30|Modifications to the case cover laser welding process parameters for the battery component.
P030022|S040|Smith & Nephew, Inc.|7135 Goodlett Farms Parkway||Cordova|TN|38016||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|REFLECTION CERAMIC ACETABULAR SYSTEM|MRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2016|11/09/2016|||APPR|Approval for the addition of an inspection step to the R3 Shells.
P030017|S262|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION NOVI MRI, SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2016|11/16/2016|||OK30|Addition of an alternate qualified supplier for the antenna shield component of the Programming Wand.
P940016|S022|B. Braun Avitum AG|SCHWARZENBERGER WEG 73-79||MELSUNGEN||D-342|3421|LIPOPROTEIN, LOW DENSITY, REMOVAL|H.E.L.P. Futura Apheresis System|MMY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2016|11/15/2016|||OK30|Substitution of the Transducer Protector present in the H.E.L.P lines with a new configuration.
P150003|S023|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2016|11/18/2016|||OK30|Updates to process parameters and software involved in the everolimus solution stent coating process.
P100045|S012|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF SYSTEM|MOM|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/17/2016|11/16/2016|||APPR|Approval for changes to the Hospital System Guide for the CardioMEMS HF System to clarify the instructions for powering down the hospital electronics unit (CM3000), and more detailed instructions for the Merlin.net setup and access.
P030017|S263|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION SPECTRA, NOVI, MONTAGE MRI AND PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2016|11/16/2016|||OK30|Change in the manufacturing process to integrate two tests into one test system.
P100026|S044|NEUROPACE INC|455 N. BERNARDO AVE||MOUNTAIN VIEW|CA|94043||Implanted brain stimulator for epilepsy|NEUROPACE RNS SYSTEM|PFN|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/17/2016|11/16/2016|||OK30|Move the location of the laser and resistance welding processes for neurostimulator and ferrule components to their new manufacturing facility in a NeuroPace’s approved sub-contractor, Cirtec Medical Systems (Cirtec), in Enfield, Connecticut.
P970004|S230|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE, N.E.||MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (URINARY)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2016|11/17/2016|||OK30|Laser welding parameters for case cover welding process for the medium rate battery line.
P080025|S125|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE|MS RCW225|MINNEAPOLIS|MN|55432||Stimulator, electrical, implantable, for incontinence|INTERSTIM THERAPY SYSTEM (BOWEL)|EZW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2016|11/17/2016|||OK30|Laser welding parameters for case cover welding process for the medium rate battery line.
P950034|S046|GENZYME CORP.|55 CAMBRIDGE PARKWAY||CAMBRIDGE|MA|02142||BARRIER, ABSORABLE, ADHESION|SEPRAFILM ADHESION BARRIER|MCN|SU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2016|11/14/2016|||OK30|Replace existing heat sealer equipment with a new heat sealer capable of processing a larger range of packaging sizes.
P010014|S059|BIOMET MANUFACTURING CORP.|56 EAST BELL DRIVE|P.O. BOX 587|WARSAW|IN|46581|0587|PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING|Oxford Partial Knee System|NRA|OR|Special (Immediate Track)|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/18/2016|11/04/2016|||APPR|Approval for updates to package sealing pressure parameters to align with validation reports.
P980016|S607|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/19/2016|11/14/2016|||OK30|Various previously accepted changes to align manufacturing of the Evera MRI and Visia AF DF-1 ICD device models with existing manufacturing, including, 1) Changes to the integrated circuit wafer manufacturing process; 2) an update to the distribution control sorter tool system; 3) updates to the post sterilization test; 4) a change to the suppliers cleaning process for the accelerometer; 5) changes to the wafer manufacturing process; 6) an update to the manufacturing inspection process for feedthrough assemblies; and 7) to update to the manufacturing execution system to FACTORYworks 9.2 at the Medtronic Tempe Campus.
P150003|S024|BOSTON SCIENTIFIC CORPORATION|One Scimed Place||Maple Grove|MN|55311||Coronary drug-eluting stent|SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2016|11/18/2016|||OK30|Alternate endotoxin sampling plan and sampling location.
P060040|S061|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/20/2016|11/17/2016|||OK30|Manufacturing process change from a manual to a semi-automatic application of adhesive during the assembly of the battery clip.
P010021|S028|Ortho-Clinical Diagnostics, Inc.|100 INDIGO CREEK DR.||ROCHESTER|NY|14626|5101|ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2016|11/30/2016|||OK30|introduction of an additional supplier for negative plasma and in-house processing steps for plasma provided by the new supplier
P030054|S313|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA.|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2016|11/17/2016|||OK30|Updated visual inspection step of device setscrews during assembly.
P910023|S376|St. Jude Medical|15900 VALLEY VIEW CT.||SYLMAR|CA|91342|3577|Implantable cardioverter defibrillator (non-CRT)|CURRENT AND FORTIFY FAMILY OF ICD DEVICES|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2016|11/17/2016|||OK30|Updated visual inspection step of device setscrews during assembly.
P030035|S150|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|ALLURE QUADRA, RF, MP|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/21/2016|11/17/2016|||OK30|Updated visual inspection step of device setscrews during assembly.
P840064|S063|ALCON LABORATORIES|6201 S FREEWAY||FT WORTH|TX|76134||AID, SURGICAL, VISCOELASTIC|DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES|LZP|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2016|11/17/2016|||OK30|Alternate supplier of the sodium hyaluronate raw material.
P080027|S024|ORASURE TECHNOLOGIES INC.|220 East First Street||Bethlehem|PA|18015||ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS|ORAQUICK HCV RAPID ANTIBODY TEST|MZO|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2016|11/18/2016|||OK30|Alternate supplier of the OraQuick housing, top and base, used in the manufacture of the device.
P150010|S001|FIDIA FARMACEUTICI|PONTE DELLA FABBRICA 3/A||ABANO TERME||35031||Acid, hyaluronic, intraarticular|HYMOVIS|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2016|11/22/2016|||OK30|Manufacturing process change to preparation of the principal bulk component.
P020045|S077|Medtronic CryoCath LP|8200 CORAL SEA STREET||MOUNDS VIEW|MN|55112||Cardiac ablation percutaneous catheter|FREEZOR CARDIAC CRYOABLATION CATHETER /XTRA SUGICAL/ MAX SURGICAL CARDIA  CRYOABLATION DEVICES, STERILE ACCESSORIES COAX|LPB|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2016|11/17/2016|||OK30|Change to the device history recording process.
P100010|S059|Medtronic CryoCath LP|8200 CORAL SEA STREET|MS MVS46|MOUNDS VIEW|MN|55112||Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|FREEZOR MAX CARDIAC CRYOABLATION CATHETER, AROTIC FRONT/AROTIC FRONT ADVANCE /AROTIC FRONT ADVANCE ST CARDIAC CRYOABLATI|OAE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2016|11/17/2016|||OK30|Change to the device history recording process.
P150023|S006|ABBOTT VASCULAR INC.|3200 Lakeside Drive||Santa Clara|CA|95054||Absorbable coronary drug-eluting stent|ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM|PNY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/24/2016|11/22/2016|||OK30|Add an alternate supplier of platinum marker beads and to automate the marker bead placement process.
P030017|S264|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2016|11/23/2016|||OK30|Addition of an alternate qualified supplier for the carbon fluorination process, which is used to produce polycarbon fluoride (CFx) material for use in the primary cell battery of the Precision Novi Implantable Pulse Generator.
P920015|S187|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Permanent defibrillator electrodes|Sprint Quattro Lead|NVY|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2016|11/22/2016|||OK30|Update process operation descriptions related to in situ molding processes.
P150016|S003|NEOMEND, INC.|60 TECHNOLOGY DR.||IRVINE|CA|92618||Sealant,polymerizing|TRIDYNE VASCULAR SEALANT|NBE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2016|11/29/2016|||OK30|Add particulate matter checks at various stages of the Tridyne Vascular Sealant manufacturing process.
P970031|S053|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|FREESTYLE AORTIC ROOT BIOPROSTHESIS|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2016|11/21/2016|||OK30|Addition of three new porcine tissue suppliers.
P990064|S064|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|MOSAIC PORCINE BIOPROSTHETIC|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2016|11/21/2016|||OK30|Addition of three new porcine tissue suppliers.
P980043|S055|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||replacement Heart-valve|HANCOCK II PORCINE BIOPROSTHESIS|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2016|11/21/2016|||OK30|Addition of three new porcine tissue suppliers.
P870078|S034|MEDTRONIC Inc.|1851 E. Deere Avenue||Santa Ana|CA|92705||replacement Heart-valve|HANCOCK LOWPOROSITY VALVED CONDUIT|DYE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2016|11/21/2016|||OK30|Addition of three new porcine tissue suppliers.
P790007|S049|MEDTRONIC HEART VALVES|1851 EAST DEERE AVE.||SANTA ANA|CA|92705||heart-valve, non-allograft tissue|HANCOCK MODIFIED ORIFICE VALVED CONDUIT|LWR|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/25/2016|11/21/2016|||OK30|Addition of three new porcine tissue suppliers.
P990056|S025|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER|ELECSYS TOTAL PSA|MTF|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2016|11/22/2016|||OK30|Move a portion of the raw material production from one building to another at the Penzberg manufacturing site.
P000027|S024|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS|ELECSYS FREE PSA|LTJ|IM|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2016|11/22/2016|||OK30|Move a portion of the raw material production from one building to another at the Penzberg manufacturing site.
P990012|S027|ROCHE DIAGNOSTICS CORP.|9115 HAGUE ROAD|P.O. BOX 50416|INDIANAPOLIS|IN|46250|0457|Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBSAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2016|11/22/2016|||OK30|Relocation of raw material production from one building to another within the same manufacturing site.
P010054|S029|ROCHE DIAGNOSTICS CORP.|9115 HAGUE RD.||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS ANTI-HBS|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2016|11/22/2016|||OK30|Relocation of raw material production from one building to another within the same manufacturing site.
P130015|S008|ROCHE DIAGNOSTICS OPERATIONS INC|9115 HAGUE RD||INDIANAPOLIS|IN|46250||Test, hepatitis b (b core, be antigen, be antibody, b core igm)|ELECSYS HBEAG|LOM|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2016|11/22/2016|||OK30|Relocation of raw material production from one building to another within the same manufacturing site.
P830055|S177|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM|NJL|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2016|11/22/2016|||OK30|Change to the TruMatch resection guide supplier facility due to relocation.
P030031|S079|BIOSENSE WEBSTER, INC.|3333 DIAMOND CANYON RD.||DIAMOND BAR|CA|91765||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|ThermoCool SmartTouch SF Bi-Directional & Uni-Directional Navigation Catheter's|OAD|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/26/2016|11/22/2016|||OK30|Use of new equipment to partially automate inspection of the Laser weld between the tip shell and sensor support of the devices affected.
P080026|S018|ABBOTT MOLECULAR, INC.|1300 EAST TOUHY AVENUE||DES PLAINES|IL|60018||Hepatitis Viral B DNA Detection|ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.|MKT|MI|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2016|11/22/2016|||OK30|Relocation of manufacturing activities for the production of Abbott mSample Preparation System bulk reagents.
P120014|S007|bioMerieux, Inc.|595 Anglum Rd.||Hazelwood|MO|63042||Somatic gene mutation detection system|THxID-BRAF kit|OWD|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2016|11/22/2016|||OK30|Change of plastic resin used to manufacture the elution tube.
P010031|S568|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.||MOUNDS VIEW|MN|55112||Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)|Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CRT-D SureScan; Compia MRI CRT-D SureScan|NIK|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2016|11/23/2016|||OK30|Iimplementation of a number of manufacturing changes previously approved for other Medtronic products.
P980016|S608|MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT|8200 CORAL SEA STREET N.E.|MS MVS11|MOUNDS VIEW|MN|55112||Implantable cardioverter defibrillator (non-CRT)|Evera MRI XT DR, VR, S DR, S VR SureScan ICD; Visia AF MRI XT, S VR SureScan ICD|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2016|11/23/2016|||OK30|Iimplementation of a number of manufacturing changes previously approved for other Medtronic products.
P000053|S071|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS SPHINCTER 800 URINARY CONTROL SYSTEM WITH AND WITHOUT INHIBIZONE TREATMENT|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/28/2016|11/22/2016|||OK30|Supplier change of the cuff backing fabric.
P110013|S078|Medtronic Vascular|3576 Unocal Place||Santa Rosa|CA|95403||Coronary drug-eluting stent|RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM|NIQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/27/2016|11/22/2016|||OK30|Remove the pre-sterilization Quality Control Visual Inspection.
P100047|S086|Medtronic|8200 Coral SeaSt. N.E.||Mounds View|MN|55112||Ventricular (assisst) bypass|HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2016|11/28/2016|||OK30|Additional testing on the output cable of the AC Power Adapter.
P830055|S178|DEPUY, INC.|P.O. BOX 988|700 ORTHOPAEDIC DRIVE|WARSAW|IN|46581|0988|Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|LCS(R) TOTAL KNEE SYSTEM|NJL|OR|Special|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2016|11/28/2016|||APPR|Approval for the addition of a verification step for the manufacturing operator to visually and audibly confirm once per shift that the ultrasonic generators turn on and transducers are audibly energized.
P070026|S043|DEPUY ORTHOPAEDICS, INC.|700 ORTHOPAEDIC DRIVE||WARSAW|IN|46582||Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|CERAMAX CERAMIC HIP SYSTEM|MRA|OR|Special|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2016|11/28/2016|||APPR|Approval for the addition of a verification step for the manufacturing operator to visually and audibly confirm once per shift that the ultrasonic generators turn on and transducers are audibly energized.
P980035|S480|MEDTRONIC Inc.|8200 CORAL SEA STREET NE|MS MV S11|MOUNDS VIEW|MN|55112||Pulse generator, permanent, implantable|Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, A|NVZ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2016|11/20/2016|||OK30|Alternate supplier for barbed fastener components.
P980037|S060|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM, ANGIOJET ULTRA DISTAFLEX THROMBECTOMY SET|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2016|12/01/2016|||OK30|a parameter change for the laser swage process of the Distaflex Thrombectomy set
P030017|S265|Boston Scientific Corp.|25155 Rye Canyon Loop||Valencia|CA|91355||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|PRECISION MONTAGE MRI AND SPINAL CORD STIMULATION(SCS) SYSTEM|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2016|11/24/2016|||OK30|Changes to the test equipment and associated software used for Continuity and HiPot testing of your Avista MRI Leads.
P110042|S069|BOSTON SCIENTIFIC CORPORATION|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Implantable cardioverter defibrillator (non-CRT)|EMBLEM™ MRI S-CD Pulse Generator (PG) Model A219, EMBLEM™ S-CD Pulse Generator (PG) Model A209|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2016|11/29/2016|||OK30|Addition of a new dispense system in the pulse generator header manufacturing process.
P850035|S043|EBI, LLC|399 JEFFERSON ROAD||PARSIPPANY|NJ|07054||Stimulator, invasive bone growth|Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6|LOE|OR|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|10/31/2016|11/17/2016|||APPR|Approval to add the following contraindication to the labeling: Any surgical implantation procedure such as minimally invasive surgical-MIS procedures requiring the SpF® Spinal Fusion Stimulators cathodes to be disconnected from their corresponding leads prior to or during implantation since this may seriously compromise the electrical performance of the implantable stimulators cathodes to deliver a constant current to the fusion site as intended.
P100045|S013|St. Jude Medical|387 TECHNOLOGY CIRCLE NW|SUITE 500|ATLANTA|GA|30313||System, hemodynamic, implantable|CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM|MOM|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|10/31/2016|11/30/2016|||OK30|revisions to the cleanroom specification for the CardioMEMS HF System at St. Jude Medical’s (SJM) Atlanta site
P040024|S094|Q-Med AB|SEMINARIEGATAN 21||UPPSALA||SE-75|752-|Implant, dermal, for aesthetic use|PERLANE|LMH|SU|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/01/2016|11/30/2016|||APPR|APPROVAL FOR REVISIONS TO PATIENT AND PROVIDER LABELING INCLUDING THE ADDITION OF LANGUAGE ON THE RISK OF INTRAVASCULAR INJECTION OF SOFT TISSUE FILLERS.
P890017|S019|CORDIS CORP.|6500 Paseo Padre Parkway||Fremont|CA|94555||STENT, CORONARY|PALMAZ BALLOON EXPANDABLE STENT|MAF|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|12/01/2016|||OK30|changes to a supplier's manufacturing equipment
P080020|S022|SEIKAGAKU CORP.|6-1, MARUNOUCHI 1-CHOME,|CHIYODA-KU|TOKYO||100-0|0005|Acid, hyaluronic, intraarticular|GEL-ONE|MOZ|OR|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|11/23/2016|||OK30|Sharing of the current facility and equipment used to manufacture Gel-One for the purpose of manufacturing another product in development.
P040045|S061|VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR|7500 CENTURION PARKWAY|SUITE 100 - ERCA|JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (SENOFILCON A) BRAND CONTACT  LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|11/22/2016|||OK30|Implement a change in the finished product parameter measurement system for the VISTAKON® (etafilcon A) and (senofilcon A) Brand Contact Lenses.
N18033|S084|VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|7500 CENTURION PKWY.||JACKSONVILLE|FL|32256||Lenses, soft contact, extended wear|VISTAKON (ETAFILCON A) BRAND  CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|11/22/2016|||OK30|Implement a change in the finished product parameter measurement system for the VISTAKON® (etafilcon A) and (senofilcon A) Brand Contact Lenses.
P140018|S005|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||Agent, occluding, vascular, permanent|VENASEAL CLOSURE SYSTEM|PJQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|12/01/2016|||OK30|modification to the material of the fill nozzle used during the vial filling process for the VenaSeal Closure System adhesive
P010032|S126|St. Jude Medical|6901 Preston Road||Plano|TX|75024||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|EON MINI, PRODIGY AND BRIO CHARGING  SYSTEMS|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|12/01/2016|||OK30|to outsource the supply of an electronic wire component in the device assembly to a new supplier Carlisle Interconnect Technologies for various external devices with a  change in the wire strip length at the tolerance level
P140009|S021|St. Jude Medical Neuromodulation|6901 PRESTON RD.||PLANO|TX|75024||STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|BRIO NEUROSTIMULATION SYSTEM|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|12/01/2016|||OK30|to outsource the supply of an electronic wire component in the device assembly to a new supplier Carlisle Interconnect Technologies for various external devices with a  change in the wire strip length at the tolerance level.
P130017|S012|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|11/17/2016|||OK30|Installation and qualification of an automated fill, cap, and label machine and the associated compressed air system at the 441 Charmany Drive manufacturing facility.
P130017|S013|Exact Sciences Corporation|441 Charmany Drive||Madison|WI|53719||System, colorectal neoplasia, DNA methylation and hemoglobin detection|COLOGUARD|PHP|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/01/2016|12/01/2016|||OK30|Scale up of kit components.
P120010|S097|MEDTRONIC Inc.|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325|1219|Artificial pancreas device system, threshold suspend|MINIMED 530G SYSTEM|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/02/2016|||OK30|to move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System
P150001|S004|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Artificial pancreas device system, threshold suspend|MINIMED 630G SYSTEM WITH SMARTGUARD|OZO|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/02/2016|||OK30|to move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System
P150019|S023|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|PARADIGM REAL-TIME REVEL SYSTEM|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/02/2016|||OK30|to move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System
P150029|S002|MEDTRONIC MINIMED|18000 DEVONSHIRE ST||NORTHRIDGE|CA|91325||Sensor, glucose, invasive|IPRO2 CGM SYSTEM WITH ENLITE SENSOR|MDS|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/02/2016|||OK30|to move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System
P160017|S005|MEDTRONIC MINIMED|18000 DEVONSHIRE STREET||NORTHRIDGE|CA|91325||Artificial pancreas device system, single hormonal control|MiniMed 670G System|OZP|CH|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/02/2016|||OK30|to move a mold to a different press and to change process parameters in the Enlite Sensor and Guardian Sensor manufacturing process. The Enlite Sensor is a component of the MiniMed-530G System, the Minimed Revel Insulin Pump System, the iPro2 CGM System, and the MiniMed 630G System. The Guardian sensor (3) is a component of the MiniMed 670G System
P110023|S022|MEDTRONIC VASCULAR INC|3033 Campus Drive||Plymouth|MN|55441||STENT, SUPERFICIAL FEMORAL ARTERY|EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|11/25/2016|||OK30|Updates to process parameters.
P060040|S063|THORATEC CORP.|6035 STONERIDGE DR.||PLEASANTON|CA|94588||Ventricular (assisst) bypass|HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)|DSQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/01/2016|||OK30|implementation of a manufacturing process change for installing the connector housing into the Battery Clip Housing
P980037|S061|Boston Scientific Corp.|9055 EVERGREEN BLVD NW||MINNEAPOLIS|MN|55433||CATHETER, CORONARY, ATHERECTOMY|AngioJet Ultra Thrombectomy System Console|MCX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/01/2016|||OK30|approval to establish alternate components for the AngioJet Ultra Console, part of the AngioJet Rheolytic Thrombectomy System
P140028|S020|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|Innova Vascular Self-Expanding Stent With Delivery System|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/01/2016|||OK30|modifications to the stent processing parameters
P950020|S076|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|Wolverine Coronary Cutting Balloon (Monorail)|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|12/01/2016|||OK30|manufacturing changes to the Distal Outer extrusion process and subsequent changes to the Distal Outer component specifications.
P980040|S075|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|11/21/2016|||OK30|Addition of a second purified water distribution loop (Loop 2) to the existing purified water system.
P990080|S044|ABBOTT MEDICAL OPTICS INC|1700 E. St. Andrew Place||Santa Ana|CA|92705||intraocular lens|CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A|HQL|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/02/2016|11/21/2016|||OK30|Addition of a second purified water distribution loop (Loop 2) to the existing purified water system.
P840001|S345|MEDTRONIC NEUROMODULATION|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432||STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF|Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads|LGW|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2016|11/28/2016|||OK30|Changes to the integrated circuit wafer manufacturing process flow for the 1.5µm High-density (HD) Bipolar and Complementary Metal Oxide Semiconductor (BiCMOS) at the Singapore AMK6 fabrication facility of Medtronics supplier, STMicroelectronics.
P960009|S264|MEDTRONIC Inc.|7000 CENTRAL AVENUE NE||MINNEAPOLIS|MN|55432|3576|STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR|Activa Deep Brain Stimulation Therapy System|MHY|NE|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2016|11/28/2016|||OK30|Changes to the integrated circuit wafer manufacturing process flow for the 1.5µm High-density (HD) Bipolar and Complementary Metal Oxide Semiconductor (BiCMOS) at the Singapore AMK6 fabrication facility of Medtronics supplier, STMicroelectronics.
N970003|S198|Boston Scientific Corp.|4100 HAMLINE AVE NORTH||ST. PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2016|11/30/2016|||OK30|the addition of an alternate supplier of titanium for pulse generator case halves
P150012|S018|BOSTONSCIENTIFIC|4100 HAMLINE AVENUE NORTH||ST PAUL|MN|55112||Implantable pulse generator, pacemaker (non-CRT)|ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI|LWP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2016|11/30/2016|||OK30|the addition of an alternate supplier of titanium for pulse generator case halves
P030005|S146|GUIDANT CORP.|4100 HAMLINE AVENUE NORTH||ST. PAUL|MN|55112|5798|Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)|VALITUDE, VALITUDE X4|NKE|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2016|11/30/2016|||OK30|the addition of an alternate supplier of titanium for pulse generator case halves
P080011|S051|COOPERVISION MANUFACTURING, LTD.|6140 STONERIDGE MALL ROAD|SUITE 500|PLEASANTON|CA|94588||Lenses, soft contact, extended wear|BIOFINITY COMFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES|LPM|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2016|11/23/2016|||OK30|Removal of UV Sterilization units from the water tanks.
P150037|S003|Alcon Research, Ltd|6201 South Freeway||Fort Worth|TX|76134||Intraocular pressure lowering implant|CyPass Stent|OGO|OP|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/03/2016|11/17/2016|||OK30|Additional Controlled Environment Room (CER) at the approved CyPass manufacturing facility.
N970012|S120|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 SERIES INFLATABLE PENILE PROSTHESIS (IPP) WITH AND WITHOUT INHIBIZONE TREATMENT|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2016|11/29/2016|||OK30|Use of a Belco Packaging Tray Sealer for the sealing of the Rear Tip Extender component packaging.
P100027|S025|VENTANA MEDICAL SYSTEMS, INC.|1910 E. Innovation Park Dr.||Tucson|AZ|85755||Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer|INFORM HER2 DUAL ISH DNA PROBE COCKTAIL|NYQ|PA|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/04/2016|11/30/2016|||OK30|a change of raw material supplier of xenograft tissue blocks.
P040027|S052|W. L. GORE & ASSOCIATES, INC.|32360 N NORTH VALLEY PARKWAY||PHOENIX|AZ|85085||SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS|GORE VIATORR TIPS|MIR|CV|Special (Immediate Track)|Labeling Change - Indications/instructions/shelf life/tradename|N|11/07/2016|11/29/2016|||APPR|Approval for an update to the Instructions for Use to indicate that in VIATORR® devices with controlled expansion, ultrasonic visualization of the lumen of the graft-lined region may be difficult through 7 days or greater post-implantation.
P990046|S048|MEDTRONIC ATS MEDICAL, INC.|3905 ANNAPOLIS LANE, SUITE 105||PLYMOUTH|MN|55447||HEART-VALVE, MECHANICAL|OPEN PIVOT MECHANICAL HEART VALVES AND OPEN PIVOT AORTIC VALVED GRAFT|LWQ|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/07/2016|12/01/2016|||OK30|upgrades to the metrology equipment and software used in manufacturing inspections of valve leaflets
P950022|S097|St. Jude Medical, Inc.|15900 VALLEY VIEW Court||SYLMAR|CA|91342||Implantable cardioverter defibrillator (non-CRT)|Durata Family Of High Voltage Leads|LWS|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2016|11/20/2016|||OK30|Updates to manufacturing tool aids and fixtures used in Durata lead manufacturing.
P040037|S095|W.L. GORE & ASSOCIATES,INC|3450 WEST KILTIE LN.|P.O. BOX 500|FLAGSTAFF|AZ|86002|0500|STENT, SUPERFICIAL FEMORAL ARTERY|GORE VIABAHN ENDOPROSTHESIS|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2016|12/01/2016|||OK30|changes to the laser used in the endoprosthesis assembly process
P130006|S034|W.L. GORE & ASSOCIATES,INC|3250 W.KILTIE LANE||FLAGSTAFF|AZ|86001||System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment|GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|PFV|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/08/2016|12/01/2016|||OK30|changes to the laser used in the endoprosthesis assembly process
P950020|S077|Boston Scientific Corp.|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring|WOLVERINE CORONARY CUTTING BALLOON MONORAIL (MR) AND OVER-THE WIRE (OTW)|NWX|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/17/2016|12/01/2016|||OK30|the addition of an alternative supplier for the atherotome microsurgical blades used on the WOLVERINE Coronary Cutting Balloon
P140028|S023|BOSTON SCIENTIFIC CORPORATION|ONE SCIMED PLACE||MAPLE GROVE|MN|55311|1566|STENT, SUPERFICIAL FEMORAL ARTERY|INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM|NIP|CV|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/22/2016|11/29/2016|||OK30|Modifications to the manufacturing equipment.
N970012|S124|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Prosthesis, penis, inflatable|AMS 700 SERIES INFLATABLE PENILE PROSTHESES|JCW|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2016|12/01/2016|||OK30|removal of inspections from the kink-resistant tubing manufacturing process
P000053|S073|Boston Scientific Corp.|100 Boston Scientific Way||Marlborough|MA|01752||Device, incontinence, mechanical/hydraulic|AMS  800 URINARY CONTROL SYSTEM|EZY|GU|30-Day Notice|Process Change - Manufacturer/Sterilizer/Packager/Supplier|N|11/29/2016|12/01/2016|||OK30|removal of inspections from the kink-resistant tubing manufacturing process